Filed by Bowne Pure Compliance
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-K
FOR ANNUAL AND TRANSITION REPORTS PURSUANT TO SECTIONS 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934. |
For the fiscal year ended December 31, 2008
or
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TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934. |
Commission File Number: 0-24006
NEKTAR THERAPEUTICS
(Exact name of registrant as specified in its charter)
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Delaware
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94-3134940 |
(State or other jurisdiction of
incorporation or organization)
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(IRS Employer
Identification No.) |
201 Industrial Road
San Carlos, California 94070
(Address of principal executive offices and zip code)
650-631-3100
(Registrants telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
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Title of Each Class
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Name of Each Exchange on Which Registered |
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Common Stock, $0.0001 par value
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NASDAQ Global Select Market |
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule
405 of the Securities Act. Yes o No þ
Indicate by check mark if the registrant is not required to file reports pursuant to Section
13 or Section 15(d) of the Act. Yes o No þ
Indicate by check mark whether the registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days) Yes þ No o
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation
S-K (§ 229.405) is not contained herein, and will not be contained, to the best of registrants
knowledge, in definitive proxy or information statements incorporated by reference in Part III of
this Form 10-K or any amendment to this Form 10-K. þ
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer, and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
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Large accelerated filer o
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Accelerated filer þ
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Non-accelerated filer o
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
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Indicate by check mark whether the registrant is a shell company (as defined in Exchange Act
Rule 12b-2) Yes o No þ
The approximate aggregate market value of voting stock held by non-affiliates of the
registrant, based upon the last sale price of the registrants common stock on the last business
day of the registrants most recently completed second fiscal quarter, June 30, 2008 (based upon
the closing sale price of the registrants common stock listed as reported on the NASDAQ Global
Select Market), was approximately $300,233,348. This calculation excludes approximately 2,792,787
shares held by directors and executive officers of the registrant. Exclusion of these shares does
not constitute a determination that each such person is an affiliate of the registrant.
As of February 27, 2009, the number of outstanding shares of the registrants common stock was
92,506,054.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of registrants definitive Proxy Statement to be filed for its 2009 Annual Meeting of
Stockholders are incorporated by reference into Part III hereof. Such Proxy Statement will be filed
with the Securities and Exchange Commission within 120 days of the end of the fiscal year covered
by this Annual Report on Form 10-K.
NEKTAR THERAPEUTICS
2008 ANNUAL REPORT ON FORM 10-K
TABLE OF CONTENTS
2
Forward-Looking Statements
This report includes forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities
Exchange Act of 1934, as amended (the Exchange Act). All statements other than statements of
historical fact are forward-looking statements for purposes of this annual report on Form 10-K,
including any projections of earnings, revenue or other financial items, any statements of the
plans and objectives of management for future operations (including, but not limited to,
pre-clinical development, clinical trials and manufacturing), any statements concerning proposed
drug candidates or other new products or services, any statements regarding future economic
conditions or performance and any statements of assumptions underlying any of the foregoing. In
some cases, forward-looking statements can be identified by the use of terminology such as may,
will, expects, plans, anticipates, estimates, potential or continue, or the negative
thereof or other comparable terminology. Although we believe that the expectations reflected in the
forward-looking statements contained herein are reasonable, such expectations or any of the
forward-looking statements may prove to be incorrect and actual results could differ materially
from those projected or assumed in the forward-looking statements. Our future financial condition
and results of operations, as well as any forward-looking statements, are subject to inherent risks
and uncertainties, including, but not limited to, the risk factors set forth in Part I, Item 1A
Risk Factors below and for the reasons described elsewhere in this annual report on Form 10-K.
All forward-looking statements and reasons why results may differ included in this report are made
as of the date hereof and we do not intend to update any forward-looking statements except as
required by law or applicable regulations.
Except where the context otherwise requires, in this annual report of Form 10-K, the
Company, Nektar, we, us, and our refer to Nektar Therapeutics, a Delaware corporation,
and, where appropriate, its subsidiaries.
Trademarks
The Nektar brand and product names, including but not limited to Nektar®, contained
in this document are trademarks, registered trademarks or service marks of Nektar Therapeutics in
the United States (U.S.) and certain other countries. This document also contains references to
trademarks and service marks of other companies that are the property of their respective owners.
3
PART I
Item 1. Business
We are a clinical-stage biopharmaceutical company developing a pipeline of drug candidates
that utilize our PEGylation and advanced polymer conjugate technology platforms, which are designed
to improve the benefits of drugs for patients. Our current proprietary product pipeline is
comprised of drug candidates across a number of therapeutic areas including oncology, pain,
anti-infectives, anti-viral and immunology. Our research and development activities involve small
molecule drugs, peptides and other potential biologic drug candidates. We create our innovative
drug candidates by using our proprietary chemistry platform to modify the chemical structure of
drugs using unique polymer conjugates. Polymer chemistry is a science focused on the synthesis or
bonding of polymer architectures with drug molecules to alter the properties of the molecule when
it is bonded with our proprietary polymers. Additionally, we may utilize established pharmacologic
targets to engineer a new drug candidate relying on a combination of the known properties of these
targets and our polymer chemistry technology and expertise. Our drug candidates are designed to
improve the pharmacokinetics, pharmacodynamics, half-life, bioavailability, metabolism or
distribution of drugs and improve the overall benefits and use of a drug for the patient. Our
objective is to apply our advanced polymer conjugate technology platform to create new drugs in
multiple therapeutic areas.
Each of our drug candidates which we are currently developing internally is a proprietary new
chemical or biological entity that addresses large potential markets. We are developing drug
candidates that can be delivered by oral or subcutaneous administration. Our most advanced
proprietary product candidate, Oral NKTR-118, is a peripheral opioid antagonist that is currently
being evaluated for the treatment of opioid-induced constipation (OIC) and we recently announced
that we were terminating our Phase 2 clinical trial for this program due to positive preliminary
results. Our other lead product candidate, NKTR-102, is a cytotoxic topoisomerase I inhibitor
that is being evaluated or will be evaluated in four separate Phase 2 clinical trials for the
treatment of multiple cancers, including ovarian, breast, cervical and colorectal.
In addition to our internal pipeline, we have a number of collaborations and license
agreements for our technology with leading biotechnology and pharmaceutical companies, including
Amgen, Schering-Plough, Baxter, UCB and Roche. A total of nine products using our PEGylation
technology platform have received regulatory approval in the U.S. or Europe, and are currently
marketed by our partners. There are also a number of other products in clinical development that
use our technology platform. These licensing collaborations will represent the majority of our
revenue stream in 2009 which will be comprised of a combination of upfront and contract research
fees, milestones, manufacturing product sales and product royalties.
We also have a significant collaboration with Bayer Healthcare LLC to develop BAY41-6551
(NKTR-061, Amikacin Inhale), which is an inhaled solution of amikacin, an aminoglycoside
antibiotic. We originally developed the liquid aerosol inhalation platform and product and entered
into a collaboration with Bayer Healthcare LLC in 2007 for its development. We have another
proprietary product candidate, NKTR-063 (Inhaled Vancomycin), which uses the same aerosol platform
as BAY41-6551. A Phase 1 clinical trial has been completed for NKTR-063 to treat patients with
Gram-positive pneumonias.
On December 31, 2008, we completed the sale and transfer of certain pulmonary technology
rights, certain pulmonary collaboration agreements and approximately 140 of our dedicated pulmonary
personnel and operations to Novartis Pharma AG. We retained all of our rights to BAY41-6551 and
NKTR-063, certain rights to receive royalties on net sales of the Cipro Inhale (also known as
Ciprofloxacin Inhaled Powder or CIP) program with Bayer Schering Pharma AG that we transferred to
Novartis as part of the transaction, and we also retained certain intellectual property rights to
patents specific to inhaled insulin. In connection with the closing of the transaction, we also
terminated the Tobramycin Inhalation Powder (TIP) collaboration agreement with Novartis.
We were incorporated in California in 1990 and reincorporated in Delaware in 1998. We maintain
our executive offices at 201 Industrial Road, San Carlos, California 94070, and our main telephone
number is (650) 631-3100.
Our Technology Platform
With our expertise as a leader in the field of PEGylation, we have advanced our technology
platform to include first-generation PEGylation and new advanced polymer conjugate chemistries that
can be tailored in very specific and customized ways to optimize and significantly improve the
profile of a wide range of molecules and many classes of drugs and disease areas.
4
PEGylation has been a highly effective technology platform for the development of therapeutics
with significant commercial success, such as Roches PEGASYS® (PEG-interferon alfa-2a) and Amgens
Neulasta® (pegfilgrastim). All of the PEGylated drugs approved over the last fourteen years were
enabled with our PEGylation technology through our collaborations and licensing partnerships with
pharmaceutical companies. PEG (polyethylene glycol) is a versatile technology and is a water
soluble, amphiphilic, non-toxic, non-immunogenic compound that is safely cleared from the body.
Its primary use to date has been in currently approved biologic drugs to favorably alter their
pharmacokinetic or pharmacodynamic properties. However, in spite of its widespread success in
commercial drugs, there are limitations with the first-generation PEGylation approaches used with
biologics. These limitations include the inability of the earlier approaches of PEGylation
technology to be used successfully with small molecule drugs, antibody fragments and peptides, all
of which could potentially benefit from the application of the technology. Other limitations of
the early approaches of PEGylation technology include resulting sub-optimal bioavailability and
bioactivity, and its limited ability to be used to fine-tune properties of the drug, as well as its
inability to be used to create oral drugs.
With our expertise and proprietary technology in PEGylation, we have created the
next-generation of PEGylation technology. Our advanced polymer conjugate technology platform is
designed to overcome the limitations of the first generation of the technology platform and allow
the platform to be utilized with a broader range of molecules across many therapeutic areas.
Both our PEGylation and advanced polymer conjugate technology platforms have the potential to
offer one or more of the following benefits:
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improve efficacy or safety in certain instances as a result of better pharmacokinetics,
pharmacodynamics, longer half-life and sustained exposure of the drug; |
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improve targeting or binding affinity of a drug to its target receptors with the
potential to improve efficacy and reduce toxicity or drug resistance; |
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enable oral administration of parenterally-administered drugs, or drugs that must be
administered intravenously or subcutaneously, and increase oral bioavailability of small
molecules; |
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prevent drugs from crossing the blood-brain barrier and limiting undesirable central
nervous system effects; |
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reduce first-pass metabolism effects of certain drug classes with the potential to
improve efficacy, which could reduce the need for other medicines and reduce toxicity; |
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reduce rate of drug absorption and of elimination or metabolism by improving stability
of the drug in the body and providing it with more sufficient time to act on its target;
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reduce immune response to certain macromolecules with the potential to prolong their
effectiveness with repeated doses. |
We have a broad range of approaches that we may use when designing our own drug candidates,
some of which are outlined below:
Small Molecule Polymer Conjugates
Our customized approaches with small molecule polymer conjugates allows for the fine-tuning of
the physicochemical and pharmacological properties of small molecule oral drugs to potentially
increase their therapeutic benefit. In addition, this approach can enable oral administration of
subcutaneously-delivered small molecule drugs that have shown low bioavailability when delivered
orally. Benefits of this approach can also include: improved potency, increased oral
bioavailability, modified biodistribution with enhanced pharmacodynamics, and reduced transport
across specific membrane barriers in the body, such as the blood-brain barrier. A primary example
of the application of membrane transport inhibition, specifically
reducing transport across the blood-brain barrier is Oral NKTR-118, a novel peripheral opioid
antagonist that is in the final stages of Phase 2 clinical
development. An example of a drug candidate that uses this approach to avoid first-pass
metabolism is NKTR-140, a novel protease inhibitor in preclinical development.
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Small Molecule Pro-Drug Conjugates
The pro-drug polymer conjugation approach can be used to optimize the pharmacokinetics and
pharmacodynamics of a small molecule drug to substantially increase both its efficacy and side
effect profile. We are currently using this platform with oncolytics, which typically have
sub-optimal half-lives that can limit their therapeutic efficacy. With our technology platform, we
believe that these drugs can be modulated for programmed release within the body, optimized
bioactivity and increased sustained exposure of active drug to tumor cells in the body. We are
using this approach with the two oncolytic candidates in our pipeline, NKTR-102, a novel PEGylated
form of irinotecan in Phase 2 clinical development, and NKTR-105, a novel PEGylated form of
docetaxel in Phase 1 clinical development.
Peptide Large Molecule Polymer Conjugates
Our customized approaches with large molecule polymer conjugates have enabled numerous
successful PEGylated biologics on the market today. We are using our advanced polymer conjugation
technology-based approach to enable peptides, which are much smaller in size than other biologics,
such as proteins and antibody fragments. We are in the early stages of research with a number of
peptides that utilize this proprietary approach. Peptides are important in modulating many
physiological processes in the body. Some of the benefits of working with peptides are: they are
small, more easily optimized, and can be rapidly investigated for therapeutic potential. However,
peptide drug discovery has been slowed by the extremely short half-life and limited bioavailability
of these molecules.
Based on our knowledge of the technology and biologics, our scientists have designed a novel
hydrolyzable linker that can be used to optimize the bioactivity of a peptide. Through rational
drug design and the use of our approach, a peptides pharmacokinetics and pharmacodynamics can be
substantially improved and its half-life can be significantly extended. The approach can also be
used with proteins and larger molecules, as well.
Antibody Fragment Conjugates
This approach uses a large molecular weight polyethylene glycol (PEG) conjugated to antibody
fragments in order to potentially improve their toxicity profile, extend their half-life and allow
for ease of synthesis with the antibody. The specially designed PEG then becomes part of the
antibody fragment Fc. Since the antibody fragment is more like a biologic, this conjugation has a
branched architecture with either stable or degradable linkage. This approach can be used to reduce
antigenicity, reduce glomerular filtration rate, and retain antigen-binding affinity and
recognition. There is currently one approved product on the market that utilizes our technology
with an antibody fragment, CIMZIA (certoluzimab pegol), which was developed by our partner UCB
Pharma and is approved for the treatment of Crohns Disease in the U.S.
Our Strategy
The key elements of our business strategy are outlined below:
Advance Our Internal Clinical Pipeline of Drug Candidates that Leverage Our PEGylation and
Advanced Polymer Conjugate Chemistry Platform
Our objective is to create value by advancing our lead drug candidates through early to
mid-stage clinical development. To support this strategy, in 2008, we significantly expanded our
strong internal expertise in our clinical development and regulatory
departments. We intend to decide on a product-by-product basis whether we wish to continue development into Phase 3 pivotal clinical
trials and commercialize products on our own, or seek a partner, or pursue a combination of these
approaches.
A key component of our development strategy is to potentially reduce the risks and time
associated with drug development by capitalizing on the known safety and efficacy of approved drugs
as well as established pharmacologic targets and drugs directed to those targets. For many of our
novel drug candidates, we may seek approval in indications for which the parent drugs have not been
studied or approved. We believe that the improved characteristics of our drug candidates will
provide meaningful benefit to patients compared to the existing therapies, and allow for approval
to provide new treatments for patients for which the parent drugs are not currently approved.
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Ensure Future Growth of our Pipeline through Internal Research Efforts and Advancement of our
Preclinical Drug Candidates into Clinical Trials
We believe it is important to maintain a diverse pipeline of new drug candidates to continue
to build on the value of our business. Our early research organization is identifying new drug
candidates by applying our technology platform to a wide range of molecule classes, including small
molecules and large proteins, peptides and antibodies, across multiple therapeutic areas. We
continue to advance our most promising early research drug candidates into preclinical development
with the objective to advance these early stage research programs to human clinical studies over
the next several years.
Enter into Strategic and High-Value Partnerships to Bring Our Drugs to Market
Our partnering strategy is to enter into collaborations with larger pharmaceutical and
biotechnology companies at appropriate stages in our drug development process to fund further
clinical development, manage the global regulatory filing process, and market and sell the approved
drugs. The options for future collaboration arrangements range from comprehensive licensing
arrangements to co-promotion and co-development agreements with the structure of the collaboration
depending on factors such as the cost and complexity of development, marketing and
commercialization needs and therapeutic area focus.
Continue to Build a Leading Intellectual Property Estate in the Field of PEGylation and
Polymer Conjugate Chemistry across Therapeutic Modalities
We are committed to continuing to build on our intellectual property position in the field of
PEGylation and polymer conjugate chemistry. To that end, we have a comprehensive patent strategy
providing us with ownership of patents and patent applications covering a wide range of
approaches, including, among others, polymer materials, conjugates, formulations, synthesis,
therapeutic areas and methods of treatment.
Approved Drugs and Drug Candidates Enabled By Our Technology through Licensing Collaborations
The following table outlines our collaborations with a number of pharmaceutical companies that
license our technology, including Amgen, Schering-Plough, Baxter, UCB and F. Hoffmann-La Roche. A
total of nine products using our PEGylation technology have received regulatory approval in the
U.S. or Europe. There are also a number of other candidates that have been filed for approval or
are in various stages of clinical development. These collaborations generally contain several
elements including license rights to our proprietary technology, manufacturing and supply
agreements under which we may receive manufacturing revenue, milestone payments, and/or product
royalties on commercial sales.
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Drug |
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Primary or Target Indications |
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Licensing Partner and Drug Marketer |
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Status(1) |
Neulasta® (pegfilgrastim)
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Neutropenia
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Amgen Inc.
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Approved |
PEGASYS® (peginterferon alfa-2a)
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Hepatitis-C
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F. Hoffmann-La Roche Ltd
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Approved |
Somavert® (pegvisomant)
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Acromegaly
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Pfizer Inc.
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Approved |
PEG-INTRON® (peginterferon alfa-2b)
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Hepatitis-C
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Schering-Plough Corporation
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Approved |
Macugen® (pegaptanib sodium injection)
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Age-related macular degeneration
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OSI Pharmaceuticals (formerly Eyetech)
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Approved |
CIMZIA (certolizumab pegol)
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Crohns disease
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UCB Pharma
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Approved in U.S. and Switzerland |
MIRCERA® (C.E.R.A.) (Continuous
Erythropoietin Receptor Activator)
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Anemia associated with chronic
kidney disease in patients on
dialysis and patients not on
dialysis
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F. Hoffmann-La Roche Ltd
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Approved in U.S. and EU
(Launched only in the EU)* |
CIMZIA (certolizumab pegol)
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Rheumatoid arthritis
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UCB Pharma
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Filed in the U.S. and EU |
Hematide(synthetic peptide-based,
erythropoiesis- stimulating agent)
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Anemia
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Affymax, Inc.
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Phase 3 |
MAP0004
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Migraine
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MAP Pharmaceuticals
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Phase 3 |
Cipro Inhale
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Cystic fibrosis lung infections
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Bayer Schering Pharma AG
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Phase 2** |
CIMZIA (certoluzimab pegol)
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Psoriasis
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UCB Pharma
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Phase 2 |
CDP-791 (PEG-antibody fragment angiogenesis
inhibitor)
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Non-small cell lung cancer
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UCB Pharma
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Phase 2 |
Longer-acting Factor VIII and other blood
clotting proteins
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Hemophilia
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Baxter
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Preclinical |
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Status definitions are: |
Approvedregulatory approval to market and sell product obtained in the U.S., EU and other
countries.
Filed Products for which a New Drug Application (NDA) or Biologics License Application (BLA) has
been filed
Phase 3 or Pivotalproduct in large-scale clinical trials conducted to obtain regulatory approval
to market and sell the drug (these trials are typically initiated following encouraging Phase 2
trial results).
Phase 2product in clinical trials to establish dosing and efficacy in patients.
Phase 1 product in clinical trials, typically in healthy subjects, to test safety. In the case of
oncology drug candidates, Phase 1 clinical trials are typically conducted in cancer patients.
Research/preclinical
product is being studied in research by way of vitro studies and/or animal studies
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Amgen Inc. prevailed in a patent lawsuit against F. Hoffmann-La Roche Ltd and as a result of this
legal ruling Roche is currently prevented from marketing MIRCERA® in the U.S. |
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This product candidate was developed using our proprietary pulmonary delivery technology that was
transferred to Novartis in an asset sale transaction that closed on December 31, 2008. As part of
the transaction, Novartis assumed our rights and obligations for our Cipro Inhale agreements with
Bayer Schering PharmaAG; however, we maintained the rights to receive certain royalties on
commercial sales of Cipro Inhale if the product candidate is approved. |
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Nektar Proprietary Internal Drug Candidates in Clinical Development
The following table summarizes our proprietary product development pipeline and significant
partnerships. The table includes the type of molecule or drug, the primary indication for the
product or product candidate, and the clinical trial status of the program.
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Drug Candidate |
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Target Indications |
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Status (1) |
BAY41-6551 (NKTR-061, Amikacin Inhale)
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Gram-negative pneumonias
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Phase 2 (Partnered with Bayer Healthcare LLC)* |
NKTR-102 (PEGylated irinotecan)
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Second-line colorectal cancer in
patients with the KRAS gene
mutation
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Phase 2 |
NKTR-102 (PEGylated irinotecan)
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Metastatic breast cancer
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Phase 2 |
NKTR-102 (PEGylated irinotecan)
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Metastatic ovarian cancer
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Phase 2 |
NKTR-102 (PEGylated irinotecan)
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Metastatic cervical cancer
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Phase 2 |
Oral NKTR-118 (PEGylated naloxol)
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Opioid-induced constipation (OIC)
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Phase 2 |
NKTR-105 (PEGylated docetaxel)
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Solid tumors
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Phase 1 |
NKTR-063 (Inhaled Vancomycin)
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Gram-positive pneumonias
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Phase 1* |
NKTR-140 (protease inhibitor candidate)
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HIV
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Research/Preclinical |
NKTR-171 (undisclosed pain candidate)
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Neuropathic pain
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Research/Preclinical |
NKTR-125 (PEGylated antihistamine candidate)
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Allergic rhinitis
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Research/Preclinical |
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(1) |
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Status definitions are: |
Phase 3 or Pivotalproduct in large-scale clinical trials conducted to obtain regulatory approval
to market and sell the drug (these trials are typically initiated following encouraging Phase 2
trial results).
Phase 2product in clinical trials to establish dosing and efficacy in patients.
Phase 1 product in clinical trials, typically in healthy subjects, to test safety. In the case of
oncology drug candidates, Phase 1 clinical trials are typically conducted in cancer patients.
Research/preclinical
product is being studied in research by way of vitro studies and/or animal studies
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This product candidate uses a liquid aerosol technology platform that was transferred to Novartis
in the pulmonary asset sale transaction that was completed on December 31, 2008. As part of that
transaction, we retained an exclusive license to this technology for the development and
commercialization of this drug candidate originally developed by Nektar.
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Overview of Selected Proprietary Product Development Programs
NKTR-102 (PEGylated irinotecan)
We are developing NKTR-102, a novel PEGylated form of irinotecan that was designed using our
advanced polymer conjugate technology platform. The product candidate is currently in Phase 2
clinical development. Irinotecan, also known as Camptosar®, is a topoisomerase I
inhibitor used for the treatment of solid tumors, including colorectal and lung cancers. By
applying our proprietary pro-drug conjugate technology to irinotecan, NKTR-102 has the potential to
be a more effective and tolerable anti-tumor agent. Using a proprietary approach that directly
conjugates the drug to a multi-arm polymer architecture, we are the first company to have created a
PEGylated small molecule with a unique pharmacokinetic profile that has demonstrated therapeutic
activity in patients.
NKTR-102 is currently in Phase 2 clinical development for the treatment of multiple cancers,
including colorectal, ovarian, and breast. In addition, we also plan to commence a Phase 2 trial
for NKTR-102 in patients with cervical cancer. A Phase 2 randomized trial of NKTR-102 was
initiated in early 2009 that will evaluate the efficacy and safety of NKTR-102 monotherapy versus
irinotecan in second-line colorectal cancer patients with the KRAS mutant gene. According to the
National Comprehensive Clinical Network, colorectal cancer is the most frequently diagnosed cancer
in men and women in the United States. In 2008, it is estimated that over 108,000 new cases of
colon cancer and approximately 40,780 cases of rectal cancer occurred. During the same year, it is
estimated that 49,960 people died from colon and rectal cancer. The primary endpoint of the Phase
2 placebo-controlled trial of NKTR-102 in colorectal cancer will be a clinically meaningful
improvement in progression-free survival as compared to standard irinotecan monotherapy. According
to recent data presented at the American Society of Clinical Oncology in 2008, it is estimated that
up to 45% of colorectal cancer cases have this mutation in the KRAS gene and do not respond to
EGFR-inhibitors, such as cetuximab. A Phase 2a study of NKTR-102 is also ongoing to evaluate
NKTR-102 in combination with cetuximab in 18 patients with refractory solid tumors, primarily
gastrointestinal-related cancers.
8
Two separate NKTR-102 Phase 2 studies are also ongoing in ovarian and breast cancers. These
studies are open label, single arm studies encompassing two treatment regimens (every 14 days or
every 21 days). Patients include those with
metastatic breast cancer with prior taxane treatment, those with metastatic and
platinum-resistant ovarian cancer. The Phase 2 study for cervical cancer that we plan to initiate
in 2009 is for patients with metastatic cervical cancer. The trials will evaluate the overall
response rate (ORR) of NKTR-102 monotherapy in each tumor setting, with secondary endpoints
including progression-free survival, safety and six and 12-month overall survival.
Ovarian, breast, and cervical cancers remain significant health problems for women worldwide.
In 2008, there were an estimated 21,650 new diagnoses and an estimated 15,520 deaths from ovarian
cancer in the United States and, historically, less than 40% of women with ovarian cancer are
cured. The American Cancer Society estimated that over 184,000 new cases of invasive breast
cancer were diagnosed and nearly 41,000 women died of breast cancer in the United States in 2008.
Cervical cancer is a major world health problem for women. The global annual incidence of cervical
cancer in 2002 was over 490,000 with an annual death rate of over 270,000. It is currently the
third most common cancer in women worldwide.
Oral NKTR-118 (PEGylated naloxol)
Oral
NKTR-118 is a novel oral drug candidate that is in the final stages
of Phase 2 clinical development, combines our
stable conjugate polymer technology with naloxol, a derivative of the opioid-antagonist drug
naloxone. On March 2, 2009, we announced that we were terminating the Phase 2 trial for Oral
NKTR-118 as a result of positive preliminary results. The peripheral opioid antagonist Oral
NKTR-118 targets opioid receptors within the enteric nervous system, which mediate opioid-induced
bowel dysfunction (OBD), a symptom resulting from opioid use that encompasses constipation,
bloating, abdominal cramping and gastroesophageal reflux. Opioid-induced constipation (OIC) is the
hallmark of this syndrome and is generally its most prominent component. According to the American
Pain Society, over 200 million opioid prescriptions are filled in the U.S. annually with worldwide
sales of opioids reaching $7.5 billion in 2007. Depending on the population studied and the
definitions used, constipation occurs in up to 90% of patients taking opioids. Currently, there
are no specific oral drugs approved or specifically indicated to treat OBD or OIC.
We are also conducting early discovery research on a new drug candidate, NKTR-119, which we
intend to develop as a co-formulation of NKTR-118 and a long-acting opioid analgesic. Our research
plan for NKTR-119 program is to create a long-acting opioid without the related gastrointestinal
side effects, such as OBD including OIC.
NKTR-105 (PEGylated docetaxel)
NKTR-105 is a novel PEGylated conjugate form of docetaxel, an anti-neoplastic agent belonging
to the taxoid family that acts by disrupting the microtubular network in cells. Docetaxel is a
major chemotherapy agent approved for use in five different cancer indications: breast, non-small
cell lung, prostate, gastric, and head and neck. Annual sales of docetaxel in 2007 exceeded $2 billion. Oncolytics, such as docetaxel, typically have sub-optimal half-lives which
can limit their therapeutic efficacy. Our advanced polymer conjugation technology can be used to
optimize the bioactivity of these drugs and increase the sustained exposure of active drug to tumor
cells in the body.
NKTR-105 is currently being evaluated in a Phase 1 clinical trial in cancer patients that
began in February 2009. The study will assess the safety, pharmacokinetics, and anti-tumor
activity of NKTR-105 in approximately 30 patients with refractory solid tumors who have failed all
prior available therapies.
NKTR-140 (protease inhibitor)
NKTR-140 is a novel protease inhibitor product candidate to treat human immunodeficiency virus
(HIV), which can lead to acquired immunodeficiency syndrome or AIDS. The product was developed
using Nektars advanced small molecule polymer conjugate technology. The drug candidate is
designed to have improved potency as compared to leading protease inhibitors used in clinical
practice today, and also to eliminate the need for a co-administered protease inhibitor booster,
such as ritonavir. NKTR-140 is currently being studied in a number of preclinical trials.
Overview of Select Licensing Partnerships for Approved Products
All of the approved products today that use our technology platforms are a result of licensing
collaborations with partners. We also have a number of product candidates in clinical development
by our partners that use our technology or involve rights over which we have patents or other
proprietary intellectual property. In a typical collaboration involving our PEGylation
technology, we license our proprietary intellectual property related to our PEGylation technology
or proprietary conjugated drug molecules in consideration for upfront payments, development
milestone payments and royalties from sales of the resulting commercial product as well as sales
milestones. We also manufacture and supply our proprietary PEGylation materials to our partners.
9
Neulasta®, Agreement with Amgen, Inc.
In July 1995, we entered into a non-exclusive supply and license agreement with Amgen, Inc.
(Amgen), pursuant to which we license our proprietary PEGylation technology to be used in the
development and manufacture of Neulasta. Neulasta selectively stimulates the production of
neutrophils that are depleted by cytotoxic chemotherapy, a condition called neutropenia that makes
it more difficult for the body to fight infections. We manufacture and supply our proprietary
PEGylation materials for Amgen on a fixed price basis. The term of the agreement is for a fixed
duration with a limited number of renewal options. This agreement is scheduled to expire in 2010.
PEGASYS®, Agreement with F. Hoffmann-La Roche Ltd
In February 1997, we entered into a license, manufacturing and supply agreement with F.
Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche), under which we granted Roche a worldwide,
exclusive license to use certain PEGylation materials to manufacture and commercialize a certain
class of products, of which PEGASYS is the only product currently commercialized. PEGASYS is
approved in the U.S., E.U. and other countries for the treatment of Hepatitis C and is designed to
help the patients immune system fight the Hepatitis C virus. We currently manufacture our
proprietary PEGylation materials for Roche on a price per gram basis. Roche has an option for a
license extension related to the agreement. The agreement expires on the later of January 10, 2015
or the expiration of our last relevant patent containing a valid claim.
Somavert®, Agreement with Pfizer, Inc.
In January 2000, we entered into a license, manufacturing and supply agreement with Sensus
Drug Development Corporation (subsequently acquired by Pharmacia Corp. in 2001 and then acquired by
Pfizer, Inc. in 2003), for the PEGylation of Somavert (pegvisomant), a human growth
hormone receptor antagonist for the treatment of acromegaly. We currently manufacture our
proprietary PEGylation reagent for Pfizer on a price per gram basis. The agreement expires on the
later of ten years from the grant of first marketing authorization in the designated territory,
which occurred in March 2003, or the expiration of our last relevant patent containing a valid
claim. In addition, Pfizer may terminate the agreement if marketing authorization is withdrawn or
marketing is no longer feasible due to certain circumstances, and either party may terminate for
cause if certain conditions are met.
PEG-Intron®, Agreement with Schering-Plough Corporation
In February 2000, we entered into a manufacturing and supply agreement with Schering-Plough
Corporation (Schering) for the manufacture and supply of our proprietary PEGylation materials to be
used by Schering in production of a pegylated recombinant human interferon-alpha (PEG-Intron).
PEG-Intron is a treatment for patients with Hepatitis C. We currently manufacture our proprietary
PEGylation materials for Schering on a price per gram basis. The agreement is for a fixed duration
with renewal terms conditioned upon mutual agreement.
Macugen®, Agreement with OSI Pharmaceuticals (formerly Eyetech)
In 2002, we entered into a license, manufacturing and supply agreement with Eyetech
Pharmaceuticals, Inc., subsequently acquired by OSI Pharmaceuticals, Inc. (OSI) in 2005, pursuant
to which we license our proprietary PEGylation technology for the development and commercialization
of Macugen®, a PEGylated anti-vascular endothelial growth factor aptamer currently approved in the
U.S. and E.U. for use in treating age-related macular degeneration. We currently manufacture our
proprietary PEGylation materials for OSI on a price per gram basis. Under the terms of the
agreement, we will receive royalties on net product sales in any particular country covered by a
valid patent claim for the longer of ten years from the date of the first commercial sale of the
product in that country or the manufacture, use or sale of such product in that country. The
agreement expires upon the expiration of our last relevant patent containing a valid claim. In
addition, OSI may terminate the agreement if marketing authorization is withdrawn or marketing is
no longer feasible due to certain circumstances, and either party may terminate for cause if
certain conditions are met.
CIMZIA, Agreement with UCB Pharma
In December 2000, we entered into a license, manufacturing and supply agreement for CIMZIA
(certolizumab pegol, CDP870) with Celltech Chiroscience Ltd., which was acquired by UCB Pharma
(UCB) in 2004. Under the terms of the agreement, UCB is responsible for all clinical development,
regulatory, and commercialization expenses. We have the right to receive manufacturing revenue on
a cost-plus basis and royalties on net product sales. We are entitled to receive
royalties on net sales of the CIMZIA product in any particular country for the longer of ten
years from the first commercial sale of the product in that country or the expiration of patent
rights in that particular country. CIMZIA is currently approved in the treatment of Crohns
Disease in the U.S. The agreement expires upon the expiration of all of UCBs royalty obligations,
provided that the agreement can be extended for successive two year renewal periods upon mutual
agreement of the parties. In addition, UCB may terminate the agreement should it cease the
development and marketing of CIMZIA and either party may terminate for cause under certain
conditions.
10
In April 2008, UCB received FDA approval for CIMZIA in the U.S. in the treatment of moderate
to severe Crohns disease. Crohns disease is a chronic digestive disorder of the intestines
commonly referred to as inflammatory bowel disease that affects an estimated 400,000 to 600,000
individuals in the U.S. In March 2008, the European Medicines Agency (EMEA) rejected the appeal
following CHMP refusal of the MAA for CIMZIA in the treatment of patients with Crohns disease, a
chronic and debilitating inflammatory disease.
In December 2007, UCB submitted a Biologics License Application (BLA) to the FDA for CIMZIA
for the treatment of rheumatoid arthritis. Rheumatoid arthritis is an autoimmune disease that
causes chronic inflammation of the joints. The submission was accepted in February of 2008. In
January 2009, UCB announced that the FDA issued a Complete Response Letter (CRL) relating to the
BLA of CIMZIA, the first PEGylated anti-TNF, for the treatment of rheumatoid arthritis. In July
2008, UCB announced that a Marketing Authorisation Application (MAA) has been submitted to and
accepted for review by the EMEA requesting the approval of CIMZIA (certolizumab pegol) as a
subcutaneous treatment for adults with moderate to severe active rheumatoid arthritis.
UCB is also conducting clinical trials on CIMZIA for psoriasis and other indications. The
product is in Phase 2 trials for the treatment of psoriasis.
MIRCERA® (C.E.R.A.) (Continuous Erythropoietin Receptor Activator), Agreement with F. Hoffmann-La
Roche Ltd
In December 2000, we entered into a license, manufacturing and supply agreement with F.
Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche), which was amended and restated in its
entirety in December 2005. Pursuant to the agreement, we license our proprietary PEGylation
materials for use in the development and manufacture of Roches MIRCERA product. MIRCERA is a
novel continuous erythropoietin receptor activator indicated for the treatment of anemia associated
with chronic kidney disease in patients on dialysis and patients not on dialysis. We are entitled
to receive royalties on net sales of the MIRCERA product in any particular country for the longer
of ten years from the first commercial sale of the product in that country or the expiration of
patent rights in that particular country. The agreement expires upon the expiration of all of
Roches royalty obligations, unless earlier terminated by Roche for convenience or by either party
for cause under certain conditions.
In April 2006, Roche filed a BLA for MIRCERA with the FDA for the treatment of anemia
associated with chronic kidney disease, including patients on dialysis or not on dialysis, and an
MAA with the EMEA to treat patients with chronic kidney disease. In May 2007, MIRCERA was approved
in the EU and the product was subsequently launched by Roche in the EU in August of 2007. In
November 2007, the FDA approved Roches BLA application for MIRCERA but the product has not been
launched in the U.S. as a result of patent-related issues.
In October 2008, a federal district court ruled in favor of Amgen Inc. in a patent
infringement lawsuit involving MIRCERA and issued a permanent injunction which prevents Roche from
marketing or selling MIRCERA in the U.S. even though the FDA approved MIRCERA. This federal
district court decision is currently on appeal to the U.S. Court of Appeals for the Federal
Circuit. Given the uncertain and lengthy nature of the legal appeal process, it is not possible
for us to estimate the timing of a decision on Roches appeal or potential remand of this case for
additional proceedings. If Roche is not successful in getting relief from the current permanent
injunction, we estimate that Roche would not be able to market or sell MIRCERA in the U.S. until
2013 at the earliest.
11
Overview of Select Partnered Drug Development Programs
BAY41-6551 (NKTR-061, Amikacin Inhale), Agreement with Bayer Healthcare LLC
In August 2007, we entered into a co-development, license and co-promotion agreement with
Bayer Healthcare LLC (Bayer) to develop a specially-formulated Amikacin (BAY41-6551, NKTR-061,
Amikacin Inhale). Under the terms of the agreement, Bayer is responsible for most future clinical
development and commercialization costs, all activities to support worldwide regulatory filings,
approvals and related activities, further development of formulated Amikacin and final product
packaging for BAY41-6551. We are responsible for any future development of the nebulizer device
used in BAY41-6551through the completion of Phase 3 clinical trials and scale-up for commercialization.
Under the terms of the agreement, we are entitled to development milestones and sales milestones
upon achievement of certain annual sales targets. We are also entitled to royalties based on
annual worldwide net sales of BAY41-6551. Our right to receive these royalties in any particular
country will expire upon the later of ten years after the first commercial sale of the product in
that country or the expiration of certain patent rights in that particular country, subject to
certain exceptions. The agreement expires in relation to a particular country upon the expiration
of all royalty and payment obligations between the parties related to such country. Subject to
termination fee payment obligations, Bayer also has the right to terminate the agreement for
convenience. In addition, the agreement may also be terminated by either party for certain product
safety concerns, the products failure to meet certain minimum commercial profile requirements or
uncured material breaches by the other party. For certain Bayer terminations, we may have
reimbursement obligations to Bayer.
BAY41-6551 is under development to treat Gram-negative pneumonias, including Hospital-Acquired
(HAP), Healthcare-Associated, and Ventilator-Associated pneumonias. Gram-negative pneumonias are
often the result of complications of other patient conditions or surgeries. BAY41-6551 will be
adjunctive therapy to the current antibiotic therapies administered intravenously as standard of
care. The targeted aerosol delivery platform in BAY41-6551 delivers antimicrobial agent directly to
the site of infection in the lungs. The product can be integrated with conventional mechanical
ventilators or used as a hand-held off-vent device for patients no longer requiring breathing
assistance.
Gram-negative pneumonia carries a mortality risk of over 50% in mechanically-ventilated
patients and accounts for a substantial proportion of the pneumonias in intensive care units (ICUs)
today.
Hematide, Agreement with Affymax, Inc.
In April 2004, we entered into a license, manufacturing and supply agreement with Affymax,
Inc. (Affymax), under which we granted Affymax a worldwide, non-exclusive license under certain of
our proprietary PEGylation technology to develop, manufacture and commercialize Hematide. We
currently manufacture our proprietary PEGylation materials for Affymax on a fixed price basis
subject to annual adjustments. Affymax has an option to convert this manufacturing pricing
arrangement to cost plus at any time prior to the date the NDA for Hematide is submitted to the
FDA. In addition, Affymax is responsible for all clinical development, regulatory and
commercialization expenses and we are entitled to development milestones and royalties on net sales
of Hematide. Our right to receive royalties in any particular country will expire upon the later
of ten years after the first commercial sale of the product in that country or the expiration of
patent rights in that particular country. The agreement expires on a country-by-country basis upon
the expiration of Affymaxs royalty obligations. The agreement may also be terminated by either
party for the other partys continued material breach after a cure period or by us in the event
that Affymax challenges the validity or enforceability of any patent licensed to them under the
agreement.
CDP-791, Agreement with UCB Pharma
In December 2000, we entered into a licensing, manufacturing and supply agreement with
Celltech Chiroscience Ltd. (subsequently acquired by UCB Pharma or UCB) for several PEGylated
antibody fragment products, one of which was a PEG-antibody fragment angiogenesis inhibitor for
non-small cell lung cancer. In August 2002, the agreement was superseded by an agreement that
relates only to CDP-791. Under the terms of the 2002 agreement, we provide development and
manufacturing services for the CDP-791 product. UCB is responsible for all clinical development,
regulatory and commercialization expenses. We have the right to receive development milestone
payments, manufacturing revenue on a cost-plus basis and royalties on net product sales following
commercial launch. Our right to receive royalties in any particular country will expire upon the
later of between ten or twelve years (which period depends on certain factors) after the first
commercial sale of the product in that country or the expiration of patent rights in that
particular country. The agreement expires upon the expiration of all of UCBs royalty obligations,
provided that the agreement can be extended for successive two year renewal periods upon mutual
agreement of the parties. In addition, UCB may terminate the agreement should it cease the
development and marketing of the product and either party may terminate for cause under certain
conditions.
12
Hemophilia Programs, Agreement with Subsidiaries of Baxter International
In September 2005, we entered into an exclusive research, development, license and
manufacturing and supply agreement with Baxter Healthcare SA and Baxter Healthcare Corporation
(Baxter) to develop products with an extended half-life for the treatment and prophylaxis of
Hemophilia A patients using our PEGylation technology. In December 2007, we expanded our agreement
with Baxter to include the license of our PEGylation technology and proprietary PEGylation methods
with the potential to improve the half-life of any future products Baxter may develop for the
treatment and prophylaxis of Hemophilia B patients. Under the terms of the agreement, we are
entitled to research and development
funding, and we manufacture our proprietary PEGylation materials for Baxter on a cost plus
basis. Baxter is responsible for all clinical development, regulatory, and commercialization
expenses. In relation to Hemophilia A, we are entitled to development milestones and royalties on
net sales varying by product and country of sale. Our right to receive these royalties in any
particular country will expire upon the later of ten years after the first commercial sale of the
product in that country or the expiration of patent rights in certain designated countries or in
that particular country. In relation to Hemophilia B, we are entitled to development and sales
milestones and royalties on net sales varying by product and country of sale. Our right to receive
these royalties in any particular country will expire upon the later of twelve years after the
first commercial sale of the product in that country or the expiration of patent rights in certain
designated countries or in that particular country. The agreement expires in relation to a
particular product and country upon the expiration of all of Baxters royalty obligations related
to such product and country. The agreement may also be terminated by either party for the other
partys material breach or insolvency, provided that such other party has been given a chance to
cure or remedy such breach or insolvency. Subject to certain limitations as to time, and possible
termination fee payment obligations, Baxter also has the right to terminate the agreement for
convenience. We have the right to terminate the agreement or convert Baxters license from
exclusive to non-exclusive in the event Baxter fails to comply with certain diligence obligations.
Cipro Inhale, Assigned to Novartis as of December 31, 2008
We were a party to a collaborative research, development and commercialization agreement with
Bayer Schering Pharma AG related to the development of an inhaled powder formulation of
Ciprofloxacin for the treatment of chronic lung infections caused by Pseudomonas aeruginosa in
cystic fibrosis patients. As of December 31, 2008, we assigned the collaborative research,
development and commercialization agreement to Novartis Pharma AG in connection with the closing of
the asset sale transaction. Pursuant to the terms of the transaction, we maintain the right to
receive certain potential royalties in the future based on net product sales if Cipro Inhale
receives regulatory approval and is successfully commercialized.
2008 Developments in Our Business
Exit from the Inhaled Insulin Programs
In 1995, we entered into a collaborative development and licensing agreement with Pfizer to
develop and market Exubera® and, in 2006 and 2007, we entered into a series of interim
letter agreements with Pfizer to develop a next generation form of dry powder inhaled insulin and
proprietary inhaler device, also known as NGI. In January 2006, Exubera received marketing approval
in the U.S. and EU for the treatment of adults with Type 1 and Type 2 diabetes. Under the
collaborative development and licensing agreement, Pfizer had sole responsibility for marketing and
selling Exubera. We performed all of the manufacturing of the Exubera dry powder insulin, and
through third party contract manufacturers (Bespak Europe Ltd. and Tech Group, Inc.), we supplied
Pfizer with the Exubera inhalers. Our total revenue from Pfizer was nil, $189.1 million, and
$139.9 million, representing 0%, 69% and 64% of total revenue, for the years ended December 31,
2008, 2007, and 2006, respectively.
On October 18, 2007, Pfizer announced that it was exiting the Exubera business and gave notice
of termination under our collaborative development and licensing agreement. On November 9, 2007,
we entered into a termination agreement and mutual release with Pfizer. Under this agreement we
received a one-time payment of $135.0 million in November 2007 from Pfizer in satisfaction of all
outstanding contractual obligations under our then-existing agreements relating to Exubera and NGI.
All agreements between Pfizer and us related to Exubera and NGI, other than the termination
agreement and mutual release and a related interim Exubera manufacturing maintenance letter,
terminated on November 9, 2007. In February 2008, we entered into a termination agreement with
Bespak and Tech Group pursuant to which we paid an aggregate of $39.9 million in satisfaction of
outstanding accounts payable and termination costs and expenses that were due under the Exubera
inhaler contract manufacturing agreement. We also entered into a maintenance agreement with both
Pfizer and Tech Group to preserve key personnel and manufacturing capacity to support potential
future Exubera inhaler manufacturing if we found a new partner for the inhaled insulin program.
On April 9, 2008, we announced that we had ceased all negotiations with potential partners for
Exubera and NGI as a result of new data analysis from ongoing clinical trials conducted by Pfizer
which indicated an increase in the number of new cases of lung cancer in Exubera patients who were
former smokers as compared to patients in the control group who were former smokers. In April
2008, we ceased all spending associated with maintaining Exubera manufacturing capacity and any
further NGI development, including, but not limited to, terminating the Exubera manufacturing
capacity maintenance arrangements with Pfizer and Tech Group.
13
Asset Sale to Novartis
On December 31, 2008, we completed the sale of certain assets related to our pulmonary
business, associated technology and intellectual property to Novartis Pharma AG and Novartis
Pharmaceuticals Corporation (together referred to as Novartis) for a purchase price of $115.0
million in cash (Novartis Pulmonary Asset Sale). Under the terms of the transaction, we
transferred to Novartis certain assets and obligations related to our pulmonary technology,
development and manufacturing operations including:
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dry powder and liquid pulmonary technology platform including but not limited to our
pulmonary inhalation devices, formulation technology, manufacturing technology and related
intellectual property; |
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capital equipment, information systems and facility lease obligations for our pulmonary
development and manufacturing facility in San Carlos, California; |
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manufacturing and associated development services payments for the Cipro Inhale program; |
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manufacturing and royalty rights to the Tobramycin Inhalation Powder (TIP) program
through the termination of our collaboration agreement with Novartis; |
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certain other interests that we had in two private companies; and |
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approximately 140 of our personnel primarily dedicated to our pulmonary technology,
development programs, and manufacturing operations. |
In consideration for the transfer of the above described pulmonary assets, we received $115.0
million in cash on December 31, 2008. In addition, we retained all of our rights to BAY41-6551,
partnered with Bayer Healthcare LLC, certain royalty rights for the Cipro Inhale development
program partnered with Bayer Schering Pharma AG, all rights to the ongoing development program for
NKTR-063, and certain intellectual property rights specific to inhaled insulin.
In connection with Novartis Pulmonary Asset Sale, we also entered into an Exclusive License
Agreement with Novartis Pharma. Pursuant to the Exclusive License Agreement, Novartis Pharma
granted back to us an exclusive, irrevocable, perpetual, non-transferable, royalty-free and
worldwide license under certain specific patent rights and other related intellectual property
rights acquired by Novartis Pharma from Nektar in the transaction, as well as certain improvements
or modifications thereto that are made by Novartis Pharma after the closing. Certain of such
patent rights and other related intellectual property rights relate to our development program for
NKTR-063 or are necessary for us to satisfy certain of our continuing contractual obligations to
third parties, including in connection with development, manufacture, sale, and commercialization
activities related to BAY41-6551. We also entered into a service agreement pursuant to which we
have subcontracted to Novartis certain services to be performed related to our partnered program
for BAY41-6551 and a transition services agreement pursuant to which Novartis and we will provide
each other with specified services for limited time periods following the closing of the Novartis
Pulmonary Asset Sale to facilitate the transition of the acquired assets and business from us to
Novartis.
Research and Development
Our total Research and development expenditures can be disaggregated into the following
significant types of expenses (in millions):
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Years ended December 31, |
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|
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2008 |
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2007 |
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2006 |
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Salaries and employee benefits |
|
$ |
58.4 |
|
|
$ |
70.7 |
|
|
$ |
69.9 |
|
Stock compensation expense |
|
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4.6 |
|
|
|
6.3 |
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|
|
9.7 |
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Facility and equipment |
|
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25.9 |
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33.9 |
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|
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31.0 |
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Outside services, including Contract Research Organizations |
|
|
40.2 |
|
|
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26.8 |
|
|
|
24.1 |
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Supplies, including clinical trial materials |
|
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19.0 |
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|
|
10.8 |
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|
|
8.9 |
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Travel, lodging, and meals |
|
|
3.3 |
|
|
|
2.2 |
|
|
|
2.4 |
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Other |
|
|
3.0 |
|
|
|
2.9 |
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|
|
3.4 |
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
$ |
154.4 |
|
|
$ |
153.6 |
|
|
$ |
149.4 |
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14
Manufacturing and Supply
We have a manufacturing facility located in Huntsville, Alabama related to our PEGylation and
advanced polymer conjugate technologies. This facility is capable of manufacturing PEGylation
derivatives and starting materials for active pharmaceutical ingredients (APIs). The facility is also used to produce
APIs for clinical development for our proprietary product candidates that utilize our PEGylation
and advanced polymer conjugate technology. The facility and associated equipment is designed and
operated to be in compliance with the guidelines of the International Conference on Harmonization
of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) applicable to
APIs (ICH Q7A guidelines).
We source drug starting materials for our manufacturing activities from one or more suppliers.
If we are responsible for manufacturing activities under a collaboration arrangement, we typically
source drug starting materials from the collaboration partner. For the drug starting materials
necessary for our proprietary drug candidate development, we have agreements for the supply of such
drug components with drug suppliers that we believe have sufficient capacity to meet our demands.
However, from time to time, we source critical raw materials from one or a limited number of
suppliers and there is a risk that if such supply were interrupted, it would materially harm our
business. In addition, we typically order raw materials on a purchase order basis and do not
enter into long-term dedicated capacity or minimum supply arrangements.
Prior to the closing of the Novartis Pulmonary Asset Sale on December 31, 2008, we operated a
drug powder manufacturing and packaging facility in San Carlos, California capable of producing
drug powders in quantities sufficient for clinical trials of product candidates utilizing our
pulmonary technology. As part of the Novartis Pulmonary Asset Sale, we transferred this
manufacturing facility and the related operations, and Novartis hired approximately 140 of the
related supporting personnel, as of December 31, 2008.
Government Regulation
The research and development, clinical testing, manufacture and marketing of products using
our technologies are subject to regulation by the Food and Drug Administration (FDA) and by
comparable regulatory agencies in other countries. These national agencies and other federal, state
and local entities regulate, among other things, research and development activities and the
testing (in vitro, in animals, and in human clinical trials), manufacture, labeling, storage,
recordkeeping, approval, marketing, advertising and promotion of our products.
The approval process required by the FDA before a product using any of our technologies may be
marketed in the U.S. depends on whether the chemical composition of the product has previously been
approved for use in other dosage forms. If the product is a new chemical entity that has not been
previously approved, the process includes the following:
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extensive preclinical laboratory and animal testing; |
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submission of an Investigational New Drug application (IND) prior to commencing
clinical trials; |
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adequate and well-controlled human clinical trials to establish the safety and
efficacy of the drug for the intended indication; and |
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submission to the FDA of a New Drug Application (NDA) for approval of a drug, a
Biologic License Application (BLA) for approval of a biological product or a Premarket
Approval Application (PMA) or Premarket Notification 510(k) for a medical device product
(a 510(k)). |
If the active chemical ingredient has been previously approved by the FDA, the approval
process is similar, except that certain preclinical tests relating to systemic toxicity normally
required for the IND and NDA or BLA may not be necessary if the company has a right of reference to
such data or is eligible for approval under Section 505(b)(2) of the Federal Food, Drug, and
Cosmetic Act.
Preclinical tests include laboratory evaluation of product chemistry and animal studies to
assess the safety and efficacy of the product and its chosen formulation. Preclinical safety tests
must be conducted by laboratories that comply with FDA good laboratory practices (GLP) regulations.
The results of the preclinical tests for drugs, biological products and
combination products subject to the primary jurisdiction of the FDAs Center for Drug
Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) are submitted
to the FDA as part of the IND and are reviewed by the FDA before clinical trials can begin.
Clinical trials may begin 30 days after receipt of the IND by the FDA, unless the FDA raises
objections or requires clarification within that period.
15
Clinical trials involve the administration of the drug to healthy volunteers or patients under
the supervision of a qualified, identified medical investigator according to a protocol submitted
in the IND for FDA review. Drug products to be used in clinical trials must be manufactured
according to current good manufacturing practices (cGMP). Clinical trials are conducted in
accordance with protocols that detail the objectives of the study and the parameters to be used to
monitor participant safety and product efficacy as well as other criteria to be evaluated in the
study. Each protocol is submitted to the FDA in the IND.
Apart from the IND process described above, each clinical study must be reviewed by an
independent Institutional Review Board (IRB) and the IRB must be kept current with respect to the
status of the clinical study. The IRB considers, among other things, ethical factors, the potential
risks to subjects participating in the trial and the possible liability to the institution where
the trial is conducted. The IRB also reviews and approves the informed consent form to be signed by
the trial participants and any significant changes in the clinical study.
Clinical trials are typically conducted in three sequential phases. Phase 1 involves the
initial introduction of the drug into healthy human subjects (in most cases) and the product
generally is tested for tolerability, pharmacokinetics, absorption, metabolism and excretion. Phase
2 involves studies in a limited patient population to:
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determine the preliminary efficacy of the product for specific targeted indications; |
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determine dosage and regimen of administration; and |
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identify possible adverse effects and safety risks. |
If Phase 2 trials demonstrate that a product appears to be effective and to have an acceptable
safety profile, Phase 3 trials are undertaken to evaluate the further clinical efficacy and safety
of the drug and formulation within an expanded patient population at geographically dispersed
clinical study sites and in large enough trials to provide statistical proof of efficacy and
tolerability. The FDA, the clinical trial sponsor, the investigators or the IRB may suspend
clinical trials at any time if any one of them believes that study participants are being subjected
to an unacceptable health risk. In some cases, the FDA and the drug sponsor may determine that
Phase 2 trials are not needed prior to entering Phase 3 trials.
Following a series of formal and informal meetings between the drug sponsor and the regulatory
agencies, the results of product development, preclinical studies and clinical studies are
submitted to the FDA as an NDA or BLA for approval of the marketing and commercial shipment of the
drug product. The FDA may deny approval if applicable regulatory criteria are not satisfied or may
require additional clinical or pharmaceutical testing or requirements. Even if such data are
submitted, the FDA may ultimately decide that the NDA or BLA does not satisfy all of the criteria
for approval. Additionally, the approved labeling may narrowly limit the conditions of use of the
product, including the intended uses, or impose warnings, precautions or contraindications which
could significantly limit the potential market for the product. Further, as a condition of
approval, the FDA may impose post-market surveillance, or Phase 4, studies or risk management
programs. Product approvals, once obtained, may be withdrawn if compliance with regulatory
standards is not maintained or if safety concerns arise after the product reaches the market. The
FDA may require additional post-marketing clinical testing and pharmacovigilance programs to
monitor the effect of drug products that have been commercialized and has the power to prevent or
limit future marketing of the product based on the results of such programs. After approval, there
are ongoing reporting obligations concerning adverse reactions associated with the product,
including expedited reports for serious and unexpected adverse events.
Each manufacturer of drug product for the U.S. market must be registered with the FDA and
typically is inspected by the FDA prior to NDA or BLA approval of a drug product manufactured by
such establishment. Establishments handling controlled substances must also be licensed by the U.S.
Drug Enforcement Administration. Manufacturing establishments of U.S. marketed products are subject
to inspections by the FDA for compliance with cGMP and other U.S. regulatory requirements. They are
also subject to U.S. federal, state, and local regulations regarding workplace safety,
environmental protection and hazardous and controlled substance controls, among others.
A number of the drugs we are developing are already approved for marketing by the FDA in
another form or using another delivery system. We believe that, when working with drugs approved in
other forms, the approval process for products using our alternative drug delivery or formulation
technologies may involve less risk and require fewer tests than new chemical entities do. However,
we expect that our formulations will often use excipients not currently approved for use. Use of
these excipients will require additional toxicological testing that may increase the costs of, or
length of time needed to, gain regulatory approval. In addition, as they relate to our products,
regulatory procedures may change as regulators gain relevant experience, and any such changes may
delay or increase the cost of regulatory approvals.
16
For product candidates currently under development utilizing pulmonary technology, the
pulmonary inhaler devices are considered to be part of a drug and device combination for deep lung
delivery of each specific molecule. The FDA will make a determination as to the most appropriate
center and division within the agency that will assume prime responsibility for the review of the
applicable applications, which would consist of an IND and an NDA or BLA where CDER or CBER are
determined to have primary jurisdiction or an investigational device exemption application and PMA
or 510(k) where the Center for Devices and Radiological Health (CDRH) is determined to have primary
jurisdiction. In the case of our product candidates, CDER in consultation with CDRH could be
involved in the review. The assessment of jurisdiction within the FDA is based upon the primary
mode of action of the drug or the location of the specific expertise in one of the centers.
Where CDRH is determined to have primary jurisdiction over a product, 510(k) clearance or PMA
approval is required. Medical devices are classified into one of three classesClass I, Class II,
or Class IIIdepending on the degree of risk associated with each medical device and the extent of
control needed to ensure safety and effectiveness. Devices deemed to pose lower risks are placed in
either Class I or II, which requires the manufacturer to submit to the FDA a Premarket Notification
requesting permission to commercially distribute the device. This process is known as 510(k)
clearance. Some low risk devices are exempted from this requirement. Devices deemed by the FDA to
pose the greatest risk, such as life-sustaining, life-supporting or implantable devices, or devices
deemed not substantially equivalent to a previously cleared 510(k) device are placed in Class III,
requiring PMA approval.
To date, our partners have generally been responsible for clinical and regulatory approval
procedures, but we may participate in this process by submitting to the FDA a drug master file
developed and maintained by us which contains data concerning the manufacturing processes for the
inhaler device or drug. For our proprietary products, we prepare and submit an IND and are
responsible for additional clinical and regulatory procedures for product candidates being
developed under an IND. The clinical and manufacturing development and regulatory review and
approval process generally takes a number of years and requires the expenditure of substantial
resources. Our ability to manufacture and market products, whether developed by us or under
collaboration agreements, ultimately depends upon the completion of satisfactory clinical trials
and success in obtaining marketing approvals from the FDA and equivalent foreign health
authorities.
Sales of our products outside the U.S. are subject to local regulatory requirements governing
clinical trials and marketing approval for drugs. Such requirements vary widely from country to
country.
In the U.S., under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs
intended to treat a rare disease or condition, which is generally a disease or condition that
affects fewer than 200,000 individuals in the U.S. The company that obtains the first FDA approval
for a designated orphan drug for a rare disease receives marketing exclusivity for use of that drug
for the designated condition for a period of seven years. In addition, the Orphan Drug Act provides
for protocol assistance, tax credits, research grants, and exclusions from user fees for sponsors
of orphan products. Once a product receives orphan drug exclusivity, a second product that is
considered to be the same drug for the same indication may be approved during the exclusivity
period only if the second product is shown to be clinically superior to the original orphan drug
in that it is more effective, safer or otherwise makes a major contribution to patient care or
the holder of exclusive approval cannot assure the availability of sufficient quantities of the
orphan drug to meet the needs of patients with the disease or condition for which the drug was
designated.
In the U.S., the FDA may grant Fast Track designation to a product candidate, which allows the
FDA to expedite the review of new drugs that are intended for serious or life-threatening
conditions and that demonstrate the potential to address unmet medical needs. An important feature
of Fast Track designation is that it emphasizes the critical nature of close, early communication
between the FDA and the sponsor company to improve the efficiency of product development.
Patents and Proprietary Rights
We invest a significant portion of our resources in the creation and development of new drug
compounds that serve unmet needs in the treatment of patients. In doing so, we create intellectual
property. As part of our strategy to secure our intellectual property created by these efforts, we
routinely apply for patents, rely on trade secret protection, and enter into contractual
obligations with third parties. When appropriate, we will defend our intellectual property, taking
any and all legal remedies available to us, including, for example, asserting patent infringement,
trade secret misappropriation and breach of contract claims. As of January 1, 2009, we owned
approximately 80 U.S. and 335 foreign patents. Currently, we have over approximately 56 patent
applications pending in the U.S. and 466 pending in other countries.
A focus area of our current drug creation and development efforts centers on our innovations
in and improvements to our PEGylation and advanced polymer conjugate technology platforms. In this
area, our patent portfolio contains patents and patent applications that encompass our PEGylation
and advanced polymer conjugate technology platforms, some of which we acquired in our acquisition
of Shearwater Corporation in June 2001. More specifically, our patents and patent applications
cover polymer architecture, drug conjugates, formulations, methods of making polymers and polymer
conjugates, and methods of administering polymer conjugates. Our patent strategy is to file patent
applications on innovations and improvements to cover a significant majority of the major
pharmaceutical markets in the world. Generally, patents have a term of twenty years from the
earliest priority date (assuming all maintenance fees are paid). In some instances, patent terms
can be increased or decreased, depending on the laws and regulations of the country or jurisdiction
that issued that patent.
17
In connection with the Novartis Pulmonary Asset Sale, as of December 31, 2008, we entered into
an exclusive license agreement with Novartis Pharma. Pursuant to the exclusive license agreement,
Novartis Pharma grants back to us an exclusive, irrevocable, perpetual, royalty-free and worldwide
license under certain specific patent rights and other related intellectual property rights
acquired by Novartis from us in the Novartis Pulmonary Asset Sale, as well as certain improvements
or modifications thereto that are made by Novartis. Certain of such patent rights and other
related intellectual property rights relate to our development program for NKTR-063 or are
necessary for us to satisfy certain continuing contractual obligations to third parties, including
in connection with development, manufacture, sale, and commercialization activities related to
BAY41-6551 partnered with Bayer Healthcare LLC.
Our revenue is derived from our collaboration agreements with partners, under which we may
receive contract research payments, milestone payments based on clinical progress, regulatory
progress or net sales achievements, royalties or manufacturing revenue. Bayer (including Bayer
Healthcare LLC and Bayer Schering Pharma AG), UCB Pharma, Novartis, and Roche represented 24%, 16%,
15%, and 14%, respectively, of our total revenue during the year ended December 31, 2008. No other
partner accounted for more than 10% of our total revenue during the year ended December 31, 2008.
If we are unable to continue to develop and protect proprietary intellectual property and license
our technologies to partners, our business, results of operations and financial condition could
suffer.
The patent positions of pharmaceutical and biotechnology companies, including ours, involve
complex legal and factual issues. There can be no assurance that the patents we apply for will be
issued to us or that the patents that are issued to us will be held valid and enforceable in a
court of law. Even for patents that are enforceable, we anticipate that any attempt to enforce our
patents would be time consuming and costly. Additionally, the coverage claimed in a patent
application can be significantly reduced before the patent is issued. As a consequence, we do not
know whether any of our pending patent applications will be granted with broad coverage or whether
the claims that eventually issue, or those that have issued, will be circumvented. Since
publication of discoveries in scientific or patent literature often lag behind actual discoveries,
we cannot be certain that we were the first inventor of inventions covered by our patents or patent
applications or that we were the first to file patent applications for such inventions. Moreover,
we may have to participate in interference proceedings in the U.S. Patent and Trademark Office,
which could result in substantial cost to us, even if the eventual outcome is favorable. An adverse
outcome could subject us to significant liabilities to third parties, require disputed rights to be
licensed from or to third parties or require us to cease using the technology in dispute.
U.S. and foreign patent rights and other proprietary rights exist that are owned by third
parties and relate to pharmaceutical compositions and reagents, medical devices and equipment and
methods for preparation, packaging and delivery of pharmaceutical compositions. We cannot predict
with any certainty which, if any, of these rights will be considered relevant to our technology by
authorities in the various jurisdictions where such rights exist, nor can we predict with certainty
which, if any, of these rights will or may be asserted against us by third parties. We could incur
substantial costs in defending ourselves and our partners against any such claims. Furthermore,
parties making such claims may be able to obtain injunctive or other equitable relief, which could
effectively block our ability to develop or commercialize some or
all of our products in the U.S. and abroad and could result in the award of substantial
damages. In the event of a claim of infringement, we or our partners may be required to obtain one
or more licenses from third parties. There can be no assurance that we can obtain a license to any
technology that we determine we need on reasonable terms, if at all, or that we could develop or
otherwise obtain alternative technology. The failure to obtain licenses if needed may have a
material adverse effect on our business, results of operations and financial condition.
We also rely on trade secret protection for our confidential and proprietary information. No
assurance can be given that we can meaningfully protect our trade secrets. Others may independently
develop substantially equivalent confidential and proprietary information or otherwise gain access
to, or disclose, our trade secrets.
In certain situations in which we work with drugs covered by one or more patents, our ability
to develop and commercialize our technologies may be affected by a limited or a complete lack of
unfettered access to these proprietary drugs. Even if we believe we are free to work with a
proprietary drug, we cannot guarantee we will not be accused of, or determined to be, infringing a
third partys rights and be prohibited from working with the drug or found liable for damages. Any
such restriction on access or liability for damages would have a material adverse effect on our
business, results of operations and financial condition.
18
It is our policy to require our employees and consultants, outside scientific collaborators,
sponsored researchers and other advisors who receive confidential information from us to execute
confidentiality agreements upon the commencement of employment or consulting relationships with us.
These agreements provide that all confidential information developed or made known to the
individual during the course of the individuals relationship with us is to be kept confidential
and not disclosed to third parties except in specific circumstances. The agreements provide that
all inventions conceived by an employee shall be our property. There can be no assurance, however,
that these agreements will provide meaningful protection or adequate remedies for our trade secrets
in the event of unauthorized use or disclosure of such information.
Backlog
In our partnered programs where we manufacture and supply our proprietary drug formulations,
inventory is produced and sales are made pursuant to customer purchase orders for delivery. The
volume of drug formulation actually purchased by our customers, as well as shipment schedules, are
subject to frequent revisions that reflect changes in both the customers needs and product
availability. In our partnered programs where we provide contract research services, those services
are typically provided under a work plan that is subject to frequent revisions that change based on
the development needs and status of the program. The backlog at a particular time is affected by a
number of factors, including scheduled date of manufacture and delivery and development program
status. In light of industry practice and our own experience, we do not believe that backlog as of
any particular date is indicative of future results.
Competition
Competition in the pharmaceutical and biotechnology industry is intense and characterized by
aggressive research and development and rapidly-evolving science, technology, and standards of
medical care throughout the world. We frequently compete with pharmaceutical companies and other
institutions with greater financial, research and development, marketing and sales, manufacturing
and managerial capabilities. We face competition from these companies not just in product
development but also in areas such as recruiting employees, acquiring technologies that might
enhance our ability to commercialize products, establishing relationships with certain research and
academic institutions, enrolling patients in clinical trials and seeking program partnerships and
collaborations with larger pharmaceutical companies.
Science and Technology Competition
We believe that our proprietary and partnered products will compete with others in the market
on the basis of one or more of the following parameters: efficacy, safety, ease of use and cost.
We face intense science and technology competition from a multitude of technologies seeking to
enhance the efficacy, safety and ease of use of approved drugs and new drug molecule candidates. A
number of the products in our pipeline have direct and indirect competition from large
pharmaceutical companies and biopharmaceutical companies. With our PEGylation and advanced polymer
conjugate technologies, we believe we have competitive advantages relating to factors such as
efficacy, safety, ease of use and cost for certain applications and molecules. We constantly
monitor scientific and medical developments in order to improve our current technologies, seek
licensing opportunities where appropriate, and determine the best applications for our technology
platforms.
In the fields of PEGylation and advanced polymer conjugate technologies, our competitors
include The Dow Chemical Company, Enzon Pharmaceuticals, Inc., SunBio Corporation, Mountain View
Pharmaceuticals, Inc., Neose Technologies, Inc., and NOF Corporation. Several other chemical,
biotechnology and pharmaceutical companies may also be developing PEGylation technology, advanced
polymer conjugate technology or technologies intended to deliver similar scientific and medical
benefits. Some of these companies license or provide the technology to other companies, while
others develop the technology for internal use.
Product and Program Specific Competition
Oral NKTR-118 (oral PEGylated naloxol)
There are no oral drugs approved specifically for the treatment of opioid-induced constipation
(OIC) or opioid bowel dysfunction (OBD). The only approved treatment for OIC is a subcutaneous
treatment known as methylnaltrexone bromide marketed by Wyeth. Other current therapies that are
utilized to treat OIC and OBD include over-the-counter laxatives and stool softeners, such as
docusate sodium, senna, and milk of magnesia. These therapies do not address the underlying cause
of constipation as a result of opioid use and are generally viewed as ineffective or only partially
effective to treat the symptoms of OID and OBD.
There are a number of companies developing potential products which are in various stages of
clinical development and are being evaluated for the treatment of OIC and OBD in different patient
populations. Potential competitors include Progenics Pharmaceuticals, Inc., Wyeth, Adolor
Corporation, GlaxoSmithKline, Mundipharma Int. Limited, Sucampo Pharmaceuticals, and Takeda
Pharmaceutical Company Limited.
19
NKTR-102 (PEGylated irinotecan)
There are a number of chemotherapies and cancer therapies approved today and in clinical
development for the treatment of colorectal cancer. Approved therapies for the treatment of
colorectal cancer include Eloxatin, Camptosar, Avastin, Erbitux, Vectibux, Xeloda, Adrucil, and
Wellcovorin. These therapies are only partially effective in treating the disease. There are a
number of drugs in various stages of preclinical and clinical development from companies exploring
cancer therapies or improved chemotherapeutic agents to potentially treat colorectal cancer. If
these drugs are approved, they could be competitive with NKTR-102. These include products in
development from Bristol-Myers Squibb Company, Pfizer, Inc., GlaxoSmithKline plc, Antigenics, Inc.,
F. Hoffman-La Roche Ltd, Novartis AG, Cell Therapeutics, Inc., Neopharm Inc., Meditech Research
Ltd, Alchemia Limited, Enzon Pharmaceuticals, Inc., and others.
There are also a number of chemotherapies and cancer therapies approved today and in various stages of clinical
development for ovarian, breast and cervical cancers including but not limited to: Avastin® (bevacizumab), Camptosar®
(irinotecan), Ellence® (epirubicin), Gemzar® (gemcitabine), Herceptin® (trastuzumab), Hycamtin® (topotecan),
Paraplatin® (carboplatin), and Taxol® (paclitaxel). These therapies are only partially effective in treating ovarian,
breast or cervical cancers. Major pharmaceutical or biotechnology companies with approved drugs or drugs in
development for these cancers include Bristol-Meyers Squibb, Genentech, Inc., GlaxoSmithKline plc, Pfizer, Inc., Eli
Lilly & Co., and many others.
BAY41-6551 (NKTR-061, Amikacin Inhale)
There are currently no approved drugs on the market for adjunctive treatment or prevention of
Gram-negative pneumonias in mechanically ventilated patients which are also administered via the
pulmonary route. The current standard of care includes approved intravenous antibiotics which are
partially effective for the treatment of either hospital-acquired pneumonia or
ventilator-associated pneumonia in patients on mechanical ventilators. These drugs include drugs
that fall into the categories of antipseudomonal cephalosporins, antipseudomonal carbepenems,
beta-Lactam/beta-lactamase inhibitors, antipseudomonal fluoroquinolones, such as Ciprofloxacin or
levofloxacin, and aminoglycosides, such as amikacin, gentamycin or Tobramycin.
Environment
As a manufacturer of drug products for the U.S. market, we are subject to inspections by the
FDA for compliance with cGMP and other U.S. regulatory requirements, including U.S. federal, state
and local regulations regarding environmental protection and hazardous and controlled substance
controls, among others. Environmental laws and regulations are complex, change frequently and have
tended to become more stringent over time. We have incurred, and may continue to incur, significant
expenditures to ensure we are in compliance with these laws and regulations. We would be subject to
significant penalties for failure to comply with these laws and regulations.
Employees and Consultants
As of December 31, 2008, after the completion of the Novartis asset sale transaction, we had
338 employees, of which 235 employees were engaged in research and development, commercial
operations and quality activities and 103 employees were engaged in general administration and
business development. Of the 338 employees, 290 were located in the United States and 48 were
located in India as of December 31, 2008. We have a number of employees who hold advanced degrees,
such as Ph.D.s. None of our employees are covered by a collective bargaining agreement, and we have
experienced no work stoppages. We believe that we maintain good relations with our employees.
To complement our own expert professional staff, we utilize specialists in regulatory affairs,
process engineering, manufacturing, quality assurance, clinical development and business
development. These individuals include certain of our scientific advisors as well as independent
consultants.
Available Information
Our website address is http://www.nektar.com. The information in, or that can be accessed
through, our website is not part of this annual report on Form 10-K. Our annual reports on Form
10-K, quarterly reports on Form 10-Q and current reports on Form 8-K and amendments to those
reports are available, free of charge, on or through our website as soon as reasonably practicable
after we electronically file such material with, or furnish it to, the Securities Exchange
Commission (SEC). The public may read and copy any materials we file with the SEC at the SECs
Public Reference Room at 100 F Street, NE, Washington, D.C. 20549. Information on the operation of
the Public Reference Room can be obtained by calling 1-800-SEC-0330. The SEC maintains an Internet
site that contains reports, proxy and information statements and other information regarding our
filings at www.sec.gov.
20
EXECUTIVE OFFICERS OF THE REGISTRANT
The following table sets forth the names, ages and positions of our executive officers as of
February 1, 2009:
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Name |
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Age |
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Position |
Howard W. Robin
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56 |
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Director, President and Chief Executive Officer |
John Nicholson
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57 |
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Senior Vice President and Chief Financial Officer |
Bharatt M. Chowrira, Ph.D., J.D.
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43 |
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Senior Vice President and Chief Operating Officer |
Randall W. Moreadith, M.D., Ph.D.
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55 |
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Senior Vice President, Drug Development and Chief Development Officer |
Gil M. Labrucherie, J.D.
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37 |
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Senior Vice President, General Counsel and Secretary |
Jillian B. Thomsen
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43 |
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Vice President and Chief Accounting Officer |
Howard W. Robin has served as our Director, President and Chief Executive Officer since
January 2007 and was appointed as a member of our Board of Directors in February 2007. Mr. Robin
served as Chief Executive Officer, President and director of Sirna Therapeutics, Inc., a
clinical-stage biotechnology company pioneering RNAi-based therapies for serious diseases and
conditions, from July 2001 to November 2006 and served as their Chief Operating Officer, President
and Director from January 2001 to June 2001. From 1991 to 2001, Mr. Robin was Corporate Vice
President and General Manager at Berlex Laboratories, Inc., the U.S. pharmaceutical subsidiary of
the German pharmaceutical firm Schering AG, and, from 1987 to 1991, he served as their Vice
President of Finance and Business Development and Chief Financial Officer. From 1984 to 1987, Mr.
Robin was Director of Business Planning and Development at Berlex and was a Senior Associate with
Arthur Andersen LLP prior to joining Berlex. Since February 2006, Mr. Robin has served as a member
of the Board of Directors of Acologix, Inc., a biopharmaceutical company focused on therapeutic
compounds for the treatment of osteo-renal diseases. He received his B.S. in Accounting and Finance
from Fairleigh Dickinson University in 1974.
John Nicholson has served as our Senior Vice President and Chief Financial Officer since
December 2007. Mr. Nicholson joined the Company as Senior Vice President of Corporate Development
and Business Operations in October 2007 and was appointed Senior Vice President and Chief Financial
Officer in December 2007. Before joining Nektar, Mr. Nicholson spent 18 years in various executive
roles at Schering Berlin, Inc., the U.S. management holding company of Bayer Schering Pharma AG, a
pharmaceutical company. From 1997, he served as Schering Berlin Inc.s Vice President of Corporate
Development and Treasurer. Since 2001, he served concurrently as the President of Schering Berlin
Insurance Co., and since 2007, he served concurrently as President of Bayer Pharma Chemicals Co.
and Schering Berlin Capital Corp. Mr. Nicholson holds a B.B.A. from the University of Toledo.
Bharatt M. Chowrira, Ph.D., J.D. has served as our Senior Vice President and Chief Operating
Officer since May 2008, as well as Chairman of Nektar Therapeutics India Pvt. Ltd. From January
2007 until May 2008, Dr. Chowrira, served as Executive Director, Licensing / External Research at
Merck & Co., Inc., a global pharmaceutical company. From January 2005 through 2006, Dr. Chowrira
served as Chief Patent Counsel and Vice President, Legal Affairs of Sirna Therapeutics, Inc., a
clinical-stage biotechnology company pioneering RNAi-based therapies for serious diseases and
conditions that was acquired by Merck & Co. in January 2007. In that position, Dr. Chowrira was
responsible for all legal and business licensing activities and general corporate matters. From
January 2002 until December 2004, Dr. Chowrira was Vice President of Legal Affairs, Licensing and
Patent Counsel at Sirna Therapeutics. Dr. Chowrira joined Sirna Therapeutics (then operating as
Ribozyme Pharmaceuticals Inc.) in 1993 as a scientist. Dr. Chowrira holds a J.D. from the College
of Law at the University of Denver and a Ph.D. in Microbiology and Molecular Genetics from the
University of Vermont. Dr. Chowrira is a member of the Colorado Bar Association, admitted to
practice in California as a registered in-house counsel, and is a registered patent attorney before
the U.S. Patent and Trademark Office. He is also a member of the American Intellectual Property Law
Association, Licensing Executive Society and the Association of Corporate Counsel.
Randall W. Moreadith, M.D., Ph.D. has served as our Senior Vice President, Drug Development
and Chief Development Officer since August 2008. From January 2006 until August 2008, Dr.
Moreadith, served as Executive Vice President and Chief Medical Officer of Cardium Therapeutics, a
company developing therapeutic products and devices for cardiovascular, ischemic and related
indications. While at Cardium, he also served as Chief Medical Officer of InnerCool Therapies, a
company focused on technology to warm and cool patients, and the Tissue Repair Company, a company
focused on the development of growth factor therapeutics that promote tissue repair and
regeneration, both of which are wholly-owned subsidiaries of Cardium and were acquired by Cardium
in 2006. From August 2004 to December 2005, Dr. Moreadith served as Chief Medical Officer of
Renovis, Inc., a company that developed drugs to treat neurological diseases and disorders. He was
a cofounder of ThromboGenics Ltd., a company developing biotherapeutics for the treatment of
vascular diseases, including acute ischemic stroke, and served as ThromboGenics President and
Chief Operating Officer from
December 1998 to December 2003. From April 1996 to February 1997, Dr. Moreadith served as
Principal Medical Officer of Quintiles, Inc. and was also a co-founder of the Cardiovascular
Therapeutics Group. He received his M.D. from Duke University and his Ph.D. from Johns Hopkins
University, and was a Howard Hughes Medical Institute Postdoctoral Fellow in Genetics at Harvard
Medical School. His faculty appointments include the University of Texas Southwestern Medical
Center, where he was an Established Investigator of the American Heart Association.
21
Gil M. Labrucherie has served as our Senior Vice President, General Counsel and Secretary
since April 2007, responsible for all aspects of our legal affairs. Mr. Labrucherie served as our
Vice President, Corporate Legal from October 2005 through April 2007. From October 2000 to
September 2005, Mr. Labrucherie was Vice President of Corporate Development at E2open. While at
E2open, Mr. Labrucherie was responsible for global corporate alliances and merger and acquisition
activity. Prior to E2open, he was the Senior Director of Corporate Development at AltaVista
Company, an Internet search company, where he was responsible for strategic partnerships and
mergers and acquisitions. Mr. Labrucherie began his career as an associate in the corporate
practice of the law firm of Wilson Sonsini Goodrich & Rosati and Graham & James (DLA Piper
Rudnick). Mr. Labrucherie received his J.D. from the Berkeley Law School and a B.A. from the
University of California Davis.
Jillian B. Thomsen has served as our Vice President Finance and Chief Accounting Officer since
April 2008. Ms. Thomsen joined Nektar in March 2006 as our Vice President Finance and Corporate
Controller. Before joining Nektar, Ms. Thomsen was Vice President Finance and Deputy Corporate
Controller of Calpine Corporation from September 2002 to February 2006. Previously, Ms. Thomsen is
a certified public accountant and was a senior manager at Arthur Andersen LLP, where she worked
from 1990 to 2002, and specialized in audits of multinational consumer products, life sciences,
manufacturing and energy companies. Ms. Thomsen holds a Masters of Accountancy from the University
of Denver and a B.A. in Business Economics from Colorado College.
Item 1A. Risk Factors
We are providing the following cautionary discussion of risk factors, uncertainties and
possibly inaccurate assumptions that we believe are relevant to our business. These are factors
that, individually or in the aggregate, we think could cause our actual results to differ
materially from expected and historical results and our forward-looking statements. We note these
factors for investors as permitted by Section 21E of the Exchange Act and Section 27A of the
Securities Act. You should understand that it is not possible to predict or identify all such
factors. Consequently, you should not consider this section to be a complete discussion of all
potential risks or uncertainties that may substantially impact our business.
Risks Related to Our Business
Drug development is an inherently uncertain process and there is a high risk of failure at every
stage of development and development failures can significantly harm our business.
We have a number of proprietary product candidates and partnered product candidates in
research and development ranging from the early discovery research phase through preclinical
testing and clinical trials. Preclinical testing and clinical trials are long, expensive and a
highly uncertain processes. It will take us, or our collaborative partners, several years to
complete clinical trials. Drug development is an uncertain scientific and medical endeavor and
failure can unexpectedly occur at any stage of clinical development. Typically, there is a high
rate of attrition for product candidates in preclinical and clinical trials due to scientific
feasibility, safety, efficacy, changing standards of medical care and other variables.
Even with success in preclinical testing and clinical trials, the risk of clinical failure
remains high prior to regulatory approval.
A number of companies in the pharmaceutical and biotechnology industries have suffered
significant unforeseen setbacks in later stage clinical trials (i.e., Phase 2 or Phase 3 trials)
due to factors such as inconclusive efficacy results and adverse medical events, even after
achieving positive results in earlier trials that were satisfactory both to them and to reviewing
regulatory agencies. Although we recently announced positive preliminary Phase 2 clinical results
for NKTR-118 (oral PEGylated naloxol), there are still substantial risks associated with the future
outcome of a Phase 3 clinical trial and the regulatory review process. In addition, although
NKTR-102 (PEGylated irinotecan) continues in active Phase 2 clinical development, there remains a
significant uncertainty that this drug candidate will eventually receive regulatory approval or
this drug candidate will be a commercial success even if approved. The risk of failure is
increased for our product candidates that are based on new technologies such as the application of
our advanced polymer conjugate technology to small molecules
including without limitation NKTR-118 and NKTR-102. If our PEGylation and advanced polymer
conjugate technologies fail to generate new drug candidates with positive clinical trial results
and approved drugs, our business would be materially harmed.
22
If we are unable to establish and maintain collaboration partnerships on attractive commercial
terms, our business, results of operations and financial condition could suffer.
We intend to continue to seek partnerships with pharmaceutical and biotechnology partners to
fund a portion of our research and development expenses and develop and commercialize our product
candidates. For example, following the recent announcement of our preliminary Phase 2 clinical
results for Oral NKTR-118 (oral PEGylated naloxol), we will be actively seeking a collaboration
partner for this program. Our ability to successfully conclude a collaboration partnership for
Oral NKTR-118 on commercially favorable terms, or at all, will have a significant impact on our
business and financial position in 2009. The timing of any future partnership, as well as the
terms and conditions of the partnership, will affect our ability to benefit from the relationship.
If we are unable to fund suitable partners or to negotiate collaborative arrangements with
favorable commercial terms with respect to our existing and future product candidates or the
licensing of our technology, or if any arrangements we negotiate, or have negotiated, are
terminated, our business, results of operations and financial condition could suffer. While we may
enter new collaboration or license agreements in 2009, we currently expect revenue to decrease in
2009 as a result of the termination of our collaboration agreements with Novartis Vaccines and
Diagnostics, Inc. for Tobramycin inhalation powder (TIP) and our assignment of our rights and
obligations, other than certain royalty rights, related to the Cipro Inhale program partnered with
Schering Pharma AG. Revenue from the TIP and Cipro Inhale collaboration agreements was $13.7
million and $11.7 million, or 15% and 13%, respectively for the year ended December 31, 2008. We
will not receive any revenue related to these programs in 2009.
The commercial potential of a drug candidate in development is difficult to predict and if the
market size for a new drug is significantly smaller than we anticipated, it could significantly and
negatively impact our revenue, results of operations and financial condition.
It is very difficult to estimate the commercial potential of product candidates due to factors
such as safety and efficacy compared to other available treatments, including potential generic
drug alternatives with similar efficacy profiles, changing standards of care, third party payer
reimbursement, patient and physician preferences and the availability of competitive alternatives
that may emerge either during the long drug development process or after commercial introduction.
If due to one or more of these risks the market potential for a product candidate is lower than we
anticipated, it could significantly and negatively impact the commercial terms of any collaboration
partnership potential for such product candidate or, if we have already entered into a
collaboration for such drug candidate, the revenue potential from royalty and milestones could be
significantly diminished and would negatively impact our revenue, results of operations and
financial condition.
Our revenue is exclusively derived from our collaboration agreements, which can result in
significant fluctuation in our revenue from period to period, and our past revenue is therefore not
necessarily indicative of our future revenue.
Our revenue is derived from our collaboration agreements with partners, under which we may
receive contract research payments, milestone payments based on clinical progress, regulatory
progress or net sales achievements, royalties or manufacturing revenue. Bayer (including Bayer
Healthcare LLC and Bayer Schering Pharma AG), UCB Pharma, Novartis, and Roche represented 24%, 16%,
15%, and 14%, respectively, of our total revenue during the year ended December 31, 2008. No other
partner accounted for more than 10% of our total revenue during the year ended December 31, 2008.
Significant variations in the timing of receipt of cash payments and our recognition of revenue can
result from the nature of significant milestone payments based on the execution of new
collaboration agreements, the timing of clinical, regulatory or sales events which result in single
milestone payments and the timing and success of the commercial launch of new drugs by our
collaboration partners. The amount of our revenue derived from collaboration agreements in any
given period will depend on a number of unpredictable factors, including our ability to find and
maintain suitable collaboration partners, the timing of the negotiation and conclusion of
collaboration agreements with such partners, whether and when we or our partner achieve clinical
and sales milestones, whether the partnership is exclusive or whether we can seek other partners,
the timing of regulatory approvals and the market introduction of new drugs, as well as other
factors.
23
If our partners, on which we depend to obtain regulatory approvals for and to commercialize our
partnered products, are not successful, or if such collaborations fail, the development or
commercialization of our partnered products may be delayed or unsuccessful.
When we sign a collaborative development agreement or license agreement to develop a product
candidate with a pharmaceutical or biotechnology company, the pharmaceutical or biotechnology
company is generally expected to:
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design and conduct large scale clinical studies; |
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prepare and file documents necessary to obtain government approvals to sell a given
product candidate; and/or |
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market and sell our products when and if they are approved. |
Our reliance on collaboration partners poses a number of risks to our business, including
risks that:
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we may be unable to control whether, and the extent to which, our partners devote
sufficient resources to the development programs or commercial efforts; |
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disputes may arise in the future with respect to the ownership of rights to
technology or intellectual property developed with partners; |
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disagreements with partners could lead to delays in, or termination of, the research,
development or commercialization of product candidates or to litigation or arbitration; |
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contracts with our partners may fail to provide us with significant protection, or to
be effectively enforced, in the event one of our partners fails to perform; |
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partners have considerable discretion in electing whether to pursue the development
of any additional product candidates and may pursue alternative technologies or products
either on their own or in collaboration with our competitors; |
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partners with marketing rights may choose to devote fewer resources to the marketing
of our partnered products than they do to products of their own development; |
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the timing and level of resources that our partners dedicate to the development
program will affect the timing and amount of revenue we receive; |
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partners may be unable to pay us as expected; and |
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partners may terminate their agreements with us unilaterally for any or no reason, in
some cases with the payment of a termination fee penalty and in other cases with no
termination fee penalty. |
Given these risks, the success of our current and future partnerships is highly uncertain. We
have entered into collaborations in the past that have been subsequently terminated, such as our
collaboration with Pfizer for the development and commercialization of inhaled insulin that was
terminated by Pfizer in November 2007. If other collaborations are suspended or terminated, our
ability to commercialize certain other proposed product candidates could also be negatively
impacted. If our collaborations fail, our product development or commercialization of product
candidates could be delayed or cancelled, which would negatively impact our business, results of
operations and financial condition.
If we or our partners do not obtain regulatory approval for our product candidates on a timely
basis, if at all, or if the terms of any approval impose significant restrictions or limitations on
use, our business, results of operations and financial condition will be negatively affected.
We or our partners may not obtain regulatory approval for product candidates on a timely
basis, if at all, or the terms of any approval (which in some countries includes pricing approval)
may impose significant restrictions or limitations on use. Product candidates must undergo rigorous
animal and human testing and an extensive FDA mandated or equivalent foreign
authorities review process for safety and efficacy. This process generally takes a number of
years and requires the expenditure of substantial resources. The time required for completing
testing and obtaining approvals is uncertain, and the FDA and other U.S. and foreign regulatory
agencies have substantial discretion to terminate clinical trials, require additional testing,
delay or withhold registration and marketing approval and mandate product withdrawals, including
recalls. In addition, undesirable side effects caused by our product candidates could cause us or
regulatory authorities to interrupt, delay or halt clinical trials and could result in a more
restricted label or the delay or denial of regulatory approval by regulatory authorities.
Even if we or our partners receive regulatory approval of a product, the approval may limit
the indicated uses for which the product may be marketed. Our partnered products that have obtained
regulatory approval, and the manufacturing processes for these products, are subject to continued
review and periodic inspections by the FDA and other regulatory authorities. Discovery from such
review and inspection of previously unknown problems may result in restrictions on marketed
products or on us, including withdrawal or recall of such products from the market, suspension of
related manufacturing operations or a more restricted label. The failure to obtain timely
regulatory approval of product candidates, any product marketing limitations or a product
withdrawal would negatively impact our business, results of operations and financial condition.
24
We are a party to numerous collaboration agreements and other significant agreements, including in
connection with the Novartis Pulmonary Asset Sale, which contain complex commercial terms that
could result in disputes, litigation or indemnification liability that could adversely affect our
business, results of operations and financial condition.
We currently derive, and expect to derive in the foreseeable future, all of our revenue from
collaboration agreements with biotechnology and pharmaceutical companies. These collaboration
agreements contain complex commercial terms, including:
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research and development performance and reimbursement obligations for our personnel
and other resources allocated to partnered product development programs; |
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clinical and commercial manufacturing agreements, some of which are priced on an
actual cost basis for products supplied by us to our partners with complicated cost
allocation formulas and methodologies; |
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intellectual property ownership allocation between us and our partners for
improvements and new inventions developed during the course of the partnership; |
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royalties on end product sales based on a number of complex variables, including net
sales calculations, geography, patent life and other financial metrics; and |
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indemnity obligations for third-party intellectual property infringement, product
liability and certain other claims. |
In addition, we have also entered into complex commercial agreements with Novartis in
connection with the sale of certain assets related to our pulmonary business, associated technology
and intellectual property to Novartis (Novartis Pulmonary Asset Sale), which was completed on
December 31, 2008. Our agreements with Novartis contain complex representations and warranties,
covenants and indemnification obligations that could result in substantial future liability and
harm our financial condition if we breach any of our agreements with Novartis or any third party
agreements impacted by this complex transaction. In addition to the asset purchase, we entered an
exclusive license agreement with Novartis Pharma pursuant to which Novartis Pharma grants back to
us an exclusive, irrevocable, perpetual, royalty-free and worldwide license under certain specific
patent rights and other related intellectual property rights necessary for us to satisfy certain
continuing contractual obligations to third parties, including in connection with development,
manufacture, sale and commercialization activities related to our partnered program for BAY41-6551
with Bayer Healthcare LLC . We also entered into a service agreement pursuant to which we have
subcontracted to Novartis certain services to be performed related to our partnered program for
BAY41-6551 and a transition services agreement pursuant to which Novartis and we will provide each
other with specified services for limited time periods following the closing of the Novartis
Pulmonary Asset Sale to facilitate the transition of the acquired assets and business from us to
Novartis.
From time to time, we have informal dispute resolution discussions with third parties
regarding the appropriate interpretation of the complex commercial terms contained in our
agreements. One or more disputes may arise in the future regarding our collaborative contracts or
the Novartis Pulmonary Asset Purchase that may ultimately result in costly litigation
and unfavorable interpretation of contract terms, which would have a material adverse impact
on our business, results of operations or financial condition.
If we or our partners are not able to manufacture drugs in quantities and at costs that are
commercially feasible, our proprietary and partnered product candidates may experience clinical
delays or constrain commercial supply which could significantly harm our business.
If we are not able to scale-up manufacturing to meet the drug quantities required to support
large clinical trials or commercial manufacturing in a timely manner or at a commercially
reasonable cost, we risk delaying our clinical trials or those of our partners and may breach
contractual obligations and incur associated damages and costs. In some cases, we may subcontract
manufacturing or other services. For instance, we entered a service agreement with Novartis
pursuant to which we subcontract to Novartis certain important services to be performed in relation
to our partnered program for BAY41-6551 with Bayer Healthcare LLC. If our subcontractors do not
dedicate adequate resources to our programs, we risk breach of our obligations to our partners.
Building and validating large scale clinical or commercial-scale manufacturing facilities and
processes, recruiting and training qualified personnel and obtaining necessary regulatory approvals
is complex, expensive and time consuming. In the past we have encountered challenges in scaling up
manufacturing to meet the requirements of large scale clinical trials without making modifications
to the drug formulation, which may cause significant delays in clinical development. Failure to
manufacture products in quantities or at costs that are commercially feasible could cause us not to
meet our supply requirements, contractual obligations or other requirements for our proprietary
product candidates and, as a result, would negatively impact our business, results of operations
and financial condition.
25
We purchase some of the raw starting material for drugs and drug candidates from a single source or
a limited number of suppliers, and the partial or complete loss of one of these suppliers could
cause production delays, clinical trial delays, substantial loss of revenue and contract liability
to third parties.
We often face very limited supply of a critical raw material that can only be obtained from a
single, or a limited number of, suppliers, which could cause production delays, clinical trial
delays, substantial lost revenue opportunity or contract liability to third parties. For example,
there are only a limited number of qualified suppliers for the raw materials included in our
PEGylation and advanced polymer conjugate drug formulations, and any interruption in supply or
failure to procure such raw materials on commercially feasible terms could harm our business by
delaying our clinical trials, impeding commercialization of approved drugs or increasing operating
loss to the extent we cannot pass on increased costs to a manufacturing customer.
The current crisis in global credit and financial markets could materially and adversely affect our
business, results of operations and financial condition.
Financial markets have experienced extreme disruption in recent months, including, among other
things, extreme volatility in security prices, severely diminished liquidity and credit
availability, rating downgrades of certain investments and declining valuations. There could be
further deterioration in credit and financial markets and confidence in economic conditions. While
we do not currently require access to credit markets to finance our operations, these economic
developments are likely to affect our business in various ways. The current tightening of credit
in financial markets may harm the ability of our partners to finance operations and they may
dedicate fewer resources to our partnered product candidates, which could result in delays in the
regulatory approval process and increase the estimated time to commercialization of our product
candidates. Since we expect that licensing deals, comprised of a combination of upfront and
contract research fees, milestones, manufacturing product sales and product royalties, will
represent the majority of our revenue in 2009, such delays could harm our business, results of
operations and financial condition. Further, our partners may be unable to continue to develop our
partnered product candidates, and some partners may terminate our collaborations. In addition, to
date all of our revenue has come from payments from partners, and it may become more difficult to
collect any payments due from our partners on a timely basis, or at all. The economic crisis may
also affect the ability of suppliers of starting materials to meet our capacity requirements or
cause them to increase the price of starting materials. We are unable to predict the likely
duration and severity of the current disruption in financial markets and adverse economic
conditions in the U.S. and other countries. As a result of the worldwide economic slowdown, it is
extremely difficult for us and our partners to forecast future sales levels based on historical
information and trends.
If any of our pending patent applications do not issue, or are deemed invalid following issuance,
we may lose valuable intellectual property protection.
The patent positions of pharmaceutical, medical device and biotechnology companies, such as
ours, are uncertain and involve complex legal and factual issues. We own approximately 80 U.S. and
approximately 335 foreign patents and a number of patent applications pending that cover various
aspects of our technologies. We have filed patent applications, and plan to file additional patent
applications, covering various aspects of our PEGylation and advanced polymer conjugate
technologies. There can be no assurance that patents that have issued will be valid and enforceable
or that patents for which we apply will issue with broad coverage, if at all. The coverage claimed
in a patent application can be significantly reduced before the patent is issued and, as a
consequence, our patent applications may result in patents with narrow coverage. Since publication
of discoveries in scientific or patent literature often lag behind the date of such discoveries, we
cannot be certain that we were the first inventor of inventions covered by our patents or patent
applications. As part of the patent application process, we may have to participate in interference
proceedings declared by the U.S. Patent and Trademark Office, which could result in substantial
cost to us, even if the eventual outcome is favorable. Further, an issued patent may undergo
further proceedings to limit its scope so as not to provide meaningful protection and any claims
that have issued, or that eventually issue, may be circumvented or otherwise invalidated. Any
attempt to enforce our patents or patent application rights could be time consuming and costly. An
adverse outcome could subject us to significant liabilities to third parties, require disputed
rights to be licensed from or to third parties or require us to cease using the technology in
dispute. Even if a patent is issued and enforceable, because development and commercialization of
pharmaceutical products can be subject to substantial delays, patents may expire early and provide
only a short period of protection, if any, following commercialization of related products.
There are many laws, regulations and judicial decisions that dictate and otherwise influence
the manner in which patent applications are filed and prosecuted and in which patents are granted
and enforced. Changes to these laws, regulations and judicial decisions are subject to influences
outside of our control and may negatively affect our business, including our ability to obtain
meaningful patent coverage or enforcement rights to any of our issued patents. New laws,
regulations and judicial decisions may be retroactive in effect, potentially reducing or
eliminating our ability to implement our patent-related strategies to these changes. Changes to
laws, regulations and judicial decisions that affect our business are often difficult or impossible
to foresee, which limits our ability to adequately adapt our patent strategies to these changes.
26
We may not be able to obtain intellectual property licenses related to the development of our
technology on a commercially reasonable basis, if at all.
Numerous pending and issued U.S. and foreign patent rights and other proprietary rights owned
by third parties relate to pharmaceutical compositions, medical devices and equipment and methods
for preparation, packaging and delivery of pharmaceutical compositions. We cannot predict with any
certainty which, if any, patent references will be considered relevant to our or our collaborative
partners technology by authorities in the various jurisdictions where such rights exist, nor can
we predict with certainty which, if any, of these rights will or may be asserted against us by
third parties. There can be no assurance that we can obtain a license to any technology that we
determine we need on reasonable terms, if at all, or that we could develop or otherwise obtain
alternate technology. If we are required to enter into a license with a third party, our potential
economic benefit for the products subject to the license will be diminished. The failure to obtain
licenses on commercially reasonable terms, or at all, if needed, would have a material adverse
effect on us.
We rely on trade secret protection and other unpatented proprietary rights for important
proprietary technologies, and any loss of such rights could harm our business, results of
operations and financial condition.
We rely on trade secret protection for our confidential and proprietary information. No
assurance can be given that others will not independently develop substantially equivalent
confidential and proprietary information or otherwise gain access to our trade secrets or disclose
such technology, or that we can meaningfully protect our trade secrets. In addition, unpatented
proprietary rights, including trade secrets and know-how, can be difficult to protect and may lose
their value if they are independently developed by a third party or if their secrecy is lost. Any
loss of trade secret protection or other unpatented proprietary rights could harm our business,
results of operations and financial condition.
We expect to continue to incur substantial losses and negative cash flow from operations and may
not achieve or sustain profitability in the future.
In the year ended December 31, 2008, we reported net losses of $34.3 million. If and when we
achieve profitability depends upon a number of factors, including the timing and recognition of
milestone payments and license fees received, the timing of revenue under collaboration agreements,
the amount of investments we make in our proprietary product candidates and the regulatory approval
and market success of our product candidates. We may not be able to achieve and sustain
profitability.
Other factors that will affect whether we achieve and sustain profitability include our
ability, alone or together with our partners, to:
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develop products utilizing our technologies, either independently or in collaboration
with other pharmaceutical or biotech companies; |
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receive necessary regulatory and marketing approvals; |
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maintain or expand manufacturing at necessary levels; |
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achieve market acceptance of our partnered products; |
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receive royalties on products that have been approved, marketed or submitted for
marketing approval with regulatory authorities; and |
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maintain sufficient funds to finance our activities. |
27
If we do not generate sufficient cash flow through increased revenue or raising additional capital,
we may not be able to meet our substantial debt obligations.
As of December 31, 2008, we had cash, cash equivalents, short-term investments and investments
in marketable securities valued at approximately $379.0 million and approximately $242.6 million of
indebtedness, including approximately $215.0 million in convertible subordinated notes due
September 2012, $21.6 million in capital lease obligations and $6.0 million of other long-term
liabilities. We expect to use a substantial portion of our cash to fund our ongoing operations over
the next few years. In the three months ended December 31, 2008, we repurchased approximately
$100.0 million in par value of our 3.25% convertible subordinated notes for an aggregate purchase
price of $47.8 million.
Our substantial indebtedness has and will continue to impact us by:
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making it more difficult to obtain additional financing; |
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constraining our ability to react quickly in an unfavorable economic climate; |
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constraining our stock price; and |
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constraining our ability to invest in our proprietary product development programs. |
Currently, we are not generating positive cash flow. If we are unable to satisfy our debt
service requirements, substantial liquidity problems could result. In relation to our convertible
subordinated notes, since the market price of our common stock is significantly below the
conversion price, the holders of our outstanding convertible subordinated notes are unlikely to
convert the notes to common stock in accordance with the existing terms of the notes. If we do not
generate sufficient cash from operations to repay principal or interest on our remaining
convertible subordinated notes, or satisfy any of our other debt obligations, when due, we may have
to raise additional funds from the issuance of equity or debt securities or otherwise restructure
our obligations. Any such financing or restructuring may not be available to us on commercially
acceptable terms, if at all.
If we cannot raise additional capital, our financial condition will suffer.
We have no material credit facility or other material committed sources of capital. To the
extent operating and capital resources are insufficient to meet our future capital needs, we will
have to raise additional funds from new collaboration partnerships or the capital markets to
continue the marketing and development of our technologies and proprietary products. Such funds may
not be available on favorable terms, if at all. We may be unable to obtain suitable new
collaboration partners on attractive terms and our substantial indebtedness may limit our ability
to obtain additional capital markets financing. If adequate funds are not available on reasonable
terms, we may be required to curtail operations significantly or obtain funds by entering into
financing, supply or collaboration agreements on unattractive terms. Our inability to raise capital
could harm our business and our stock price. To the extent that additional capital is raised
through the sale of equity or convertible debt securities, the issuance of such securities would
result in dilution to our stockholders.
If government and private insurance programs do not provide reimbursement for our partnered
products or proprietary products, those products will not be widely accepted, which would have a
negative impact on our business, results of operations and financial condition.
In both domestic and foreign markets, sales of our partnered and proprietary products that
have received regulatory approval will depend in part on market acceptance among physicians and
patients, pricing approvals by government authorities and the availability of reimbursement from
third-party payers, such as government health administration authorities, managed care providers,
private health insurers and other organizations. Such third-party payers are increasingly
challenging the price and cost effectiveness of medical products and services. Therefore,
significant uncertainty exists as to the pricing approvals for, and the reimbursement status of,
newly approved healthcare products. Moreover, legislation and regulations affecting the pricing of
pharmaceuticals may change before regulatory agencies approve our proposed products for marketing
and could further limit pricing approvals for, and reimbursement of, our products from government
authorities and third-party payers. A government or third-party payer decision not to approve
pricing for, or provide adequate coverage and reimbursements of, our products would limit market
acceptance of such products.
We depend on third parties to conduct the clinical trials for our proprietary product candidates
and any failure of those parties to fulfill their obligations could harm our development and
commercialization plans.
We depend on independent clinical investigators, contract research organizations and other
third-party service providers to conduct clinical trials for our proprietary product candidates.
Though we rely heavily on these parties for successful execution of our clinical trials and are
ultimately responsible for the results of their activities, many aspects of their activities are
beyond our control. For example, we are responsible for ensuring that each of our clinical trials
is conducted in accordance with the general investigational plan and protocols for the trial, but
the independent clinical investigators may prioritize other projects over ours or communicate
issues regarding our products to us in an untimely manner. Third parties may not complete
activities on schedule or may not conduct our clinical trials in accordance with regulatory
requirements or our stated protocols. The early termination of any of our clinical trial
arrangements, the failure of third parties to comply with the regulations and requirements
governing clinical trials or our reliance on results of trials that we have not directly conducted
or monitored could hinder or delay the development, approval and commercialization of our product
candidates and would adversely affect our business, results of operations and financial condition.
28
Our manufacturing operations and those of our contract manufacturers are subject to governmental
regulatory requirements, which, if not met, would have a material adverse effect on our business,
results of operations and financial condition.
We and our contract manufacturers are required in certain cases to maintain compliance with
current good manufacturing practices (cGMP), including cGMP guidelines applicable to active
pharmaceutical ingredients, and are subject to inspections by the FDA or comparable agencies in
other jurisdictions to confirm such compliance. We anticipate periodic regulatory inspections of
our drug manufacturing facilities and the manufacturing facilities of our contract manufacturers
for compliance with applicable regulatory requirements. Any failure to follow and document our or
our contract manufacturers adherence to such cGMP regulations or satisfy other manufacturing and
product release regulatory requirements may lead to significant delays in the availability of
products for commercial use or clinical study, result in the termination or hold on a clinical
study or delay or prevent filing or approval of marketing applications for our products. Failure to
comply with applicable regulations may also result in sanctions being imposed on us, including
fines, injunctions, civil penalties, failure of regulatory authorities to grant marketing approval
of our products, delays, suspension or withdrawal of approvals, license revocation, seizures or
recalls of products, operating restrictions and criminal prosecutions, any of which could harm our
business. The results of these inspections could result in costly manufacturing changes or
facility or capital equipment upgrades to satisfy the FDA that our manufacturing and quality
control procedures are in substantial compliance with cGMP. Manufacturing delays, for us or our
contract manufacturers, pending resolution of regulatory deficiencies or suspensions would have a
material adverse effect on our business, results of operations and financial condition.
Significant competition for our polymer conjugate chemistry technology platforms, our partnered and
proprietary products and product candidates could make our technologies, products or product
candidates obsolete or uncompetitive, which would negatively impact our business, results of
operations and financial condition.
Our PEGylation and advanced polymer conjugate chemistry platforms and our partnered and
proprietary products and product candidates compete with various pharmaceutical and biotechnology
companies. Competitors of our PEGylation and polymer conjugate chemistry technologies include The
Dow Chemical Company, Enzon Pharmaceuticals, Inc., SunBio Corporation, Mountain View
Pharmaceuticals, Inc., Neose Technologies, Inc., and NOF Corporation. Several other chemical,
biotechnology and pharmaceutical companies may also be developing PEGylation technologies or
technologies that have similar impact on target drug molecules. Some of these companies license or
provide the technology to other companies, while others are developing the technology for internal
use.
There are several competitors for our proprietary product candidates currently in development.
For NKTR-061 (inhaled Amikacin), the current standard of care includes several approved intravenous
antibiotics for the treatment of either hospital-acquired pneumonia or ventilator-associated
pneumonia in patients on mechanical ventilators. For NKTR-118 (PEGylated naloxol), there are
currently several alternative therapies used to address opioid-induced constipation (OIC) and
opioid-induced bowel dysfunction (OBD), including over-the-counter laxatives and stool softeners
such as docusate sodium, senna and milk of magnesia. In addition, there are a number of companies
developing potential products which are in various stages of clinical development and are being
evaluated for the treatment of OIC and OBD in different patient populations, including Adolor
Corporation, GlaxoSmithKline, Progenics Pharmaceuticals, Inc., Wyeth, Mundipharma Int. Limited,
Sucampo Pharmaceuticals and Takeda Pharmaceutical Company Limited. For NKTR-102 (PEG-irinotecan),
there are a number of approved therapies for the treatment of colorectal cancer, including
Eloxatin, Camptosar, Avastin, Erbitux, Vectibux, Xeloda, Adrucil and Wellcovorin. In addition,
there are a number of drugs in various stages of preclinical and clinical development from
companies exploring cancer therapies or improved chemotherapeutic agents to potentially treat
colorectal cancer, including, but not limited to, products in development from Bristol-Myers Squibb
Company, Pfizer, Inc., GlaxoSmithKline plc, Antigenics, Inc., F. Hoffmann-La Roche Ltd, Novartis
AG, Cell Therapeutics, Inc., Neopharm Inc., Meditech Research Ltd, Alchemia Limited, Enzon
Pharmaceuticals, Inc. and others.
There can be no assurance that we or our partners will successfully develop, obtain regulatory
approvals and commercialize next-generation or new products that will successfully compete with
those of our competitors. Many of our competitors have greater financial, research and development,
marketing and sales, manufacturing and managerial capabilities. We face competition from these
companies not just in product development but also in areas such as recruiting employees, acquiring
technologies that might enhance our ability to commercialize products, establishing relationships
with certain research and academic institutions, enrolling patients in clinical trials and seeking
program partnerships and collaborations with larger pharmaceutical companies. As a result, our
competitors may succeed in developing competing technologies, obtaining regulatory approval or
gaining market acceptance for products before we do. These developments could make our products or
technologies uncompetitive or obsolete.
29
We could be involved in legal proceedings and may incur substantial litigation costs and
liabilities that will adversely affect our business, results of operations and financial condition.
From time to time, third parties have asserted, and may in the future assert, that we or our
partners infringe their proprietary rights. The third party often bases its assertions on a claim
that its patents cover our technology. Similar assertions of infringement could be based on future
patents that may issue to third parties. In certain of our agreements with our partners, we are
obligated to indemnify and hold harmless our partners from intellectual property infringement,
product liability and certain other claims, which could cause us to incur substantial costs if we
are called upon to defend ourselves and our partners against any claims. If a third party obtains
injunctive or other equitable relief against us or our partners, they could effectively prevent us,
or our partners, from developing or commercializing, or deriving revenue from, certain products or
product candidates in the U.S. and abroad. For instance, F. Hoffmann-La Roche Ltd, to which we
license our proprietary PEGylation reagent for use in the MIRCERA product, was a party to a
significant patent infringement lawsuit brought by Amgen Inc. related to Roches proposed marketing
and sale of MIRCERA to treat chemotherapy anemia in the U.S. Amgen prevailed in this lawsuit and a
U.S. federal district court issued an injunction preventing Roche from marketing and selling
MIRCERA in the U.S. Third-party claims could also result in the award of substantial damages to be
paid by us or a
settlement resulting in significant payments to be made by us. For instance, a settlement
might require us to enter a license agreement under which we pay substantial royalties to a third
party, diminishing our future economic returns from the related product. In 2006, we entered into a
litigation settlement related to an intellectual property dispute with the University of Alabama in
Huntsville pursuant to which we paid $11.0 million and agreed to pay an additional $10.0 million in
equal $1.0 million installments over ten years ending with the last payment due on July 1, 2016. We
cannot predict with certainty the eventual outcome of any pending or future litigation. Costs
associated with such litigation, substantial damage claims, indemnification claims or royalties
paid for licenses from third parties could have a material adverse effect on our business, results
of operations and financial condition.
If product liability lawsuits are brought against us, we may incur substantial liabilities.
The manufacture, clinical testing, marketing and sale of medical products involve inherent
product liability risks. If product liability costs exceed our product liability insurance
coverage, we may incur substantial liabilities that could have a severe negative impact on our
financial position. Whether or not we are ultimately successful in any product liability
litigation, such litigation would consume substantial amounts of our financial and managerial
resources and might result in adverse publicity, all of which would impair our business.
Additionally, we may not be able to maintain our clinical trial insurance or product liability
insurance at an acceptable cost, if at all, and this insurance may not provide adequate coverage
against potential claims or losses.
Our future depends on the proper management of our current and future business operations and their
associated expenses.
Our business strategy requires us to manage our business to provide for the continued
development and potential commercialization of our proprietary and partnered product candidates.
Our strategy also calls for us to undertake increased research and development activities and to
manage an increasing number of relationships with partners and other third parties, while
simultaneously managing the expenses generated by these activities. If we are unable to manage
effectively our current operations and any growth we may experience, our business, financial
condition and results of operations may be adversely affected. If we are unable to effectively
manage our expenses, we may find it necessary to reduce our personnel-related costs through further
reductions in our workforce, which could harm our operations, employee morale and impair our
ability to retain and recruit talent. Furthermore, if adequate funds are not available, we may be
required to obtain funds through arrangements with partners or other sources that may require us to
relinquish rights to certain of our technologies or products that we would not otherwise
relinquish.
We are dependent on our management team and key technical personnel, and the loss of any key
manager or employee may impair our ability to develop our products effectively and may harm our
business, operating results and financial condition.
Our success largely depends on the continued services of our executive officers and other key
personnel. The loss of one or more members of our management team or other key employees could
seriously harm our business, operating results and financial condition. The relationships that our
key managers have cultivated within our industry make us particularly dependent upon their
continued employment with us. We are also dependent on the continued services of our technical
personnel because of the highly technical nature of our products and the regulatory approval
process. Because our executive officers and key employees are not obligated to provide us with
continued services, they could terminate their employment with us at any time without penalty. We
do not have any post-employment noncompetition agreements with any of our employees and do not
maintain key person life insurance policies on any of our executive officers or key employees.
30
Because competition for highly qualified technical personnel is intense, we may not be able to
attract and retain the personnel we need to support our operations and growth.
We must attract and retain experts in the areas of clinical testing, manufacturing,
regulatory, finance, marketing and distribution and develop additional expertise in our existing
personnel. We face intense competition from other biopharmaceutical companies, research and
academic institutions and other organizations for qualified personnel. Many of the organizations
with which we compete for qualified personnel have greater resources than we have. Because
competition for skilled personnel in our industry is intense, companies such as ours sometimes
experience high attrition rates with regard to their skilled employees. Further, in making
employment decisions, job candidates often consider the value of the stock options they are to
receive in connection with their employment. Our equity incentive plan and employee benefit plans
may not be effective in motivating or retaining our employees or attracting new employees, and
significant volatility in the price
of our stock may adversely affect our ability to attract or retain qualified personnel. If we
fail to attract new personnel or to retain and motivate our current personnel, our business and
future growth prospects could be severely harmed.
If earthquakes and other catastrophic events strike, our business may be harmed.
Our corporate headquarters, including a substantial portion of our research and development
operations, are located in the San Francisco Bay Area, a region known for seismic activity and a
potential terrorist target. In addition, we own facilities for the manufacture of products using
our PEGylation and advanced polymer conjugate technologies in Huntsville, Alabama and lease offices
in Hyderabad, India. There are no backup facilities for our manufacturing operations located in
Huntsville, Alabama. In the event of an earthquake or other natural disaster or terrorist event in
any of these locations, our ability to manufacture and supply materials for drug candidates in
development and our ability to meet our manufacturing obligations to our customers would be
significantly disrupted and our business, results of operations and financial condition would be
harmed. Our collaborative partners may also be subject to catastrophic events, such as hurricanes
and tornadoes, any of which could harm our business, results of operations and financial condition.
We have not undertaken a systematic analysis of the potential consequences to our business, results
of operations and financial condition from a major earthquake or other catastrophic event, such as
a fire, sustained loss of power, terrorist activity or other disaster, and do not have a recovery
plan for such disasters. In addition, our insurance coverage may not be sufficient to compensate us
for actual losses from any interruption of our business that may occur.
We have implemented certain anti-takeover measures, which make it more difficult to acquire us,
even though such acquisitions may be beneficial to our stockholders.
Provisions of our certificate of incorporation and bylaws, as well as provisions of Delaware
law, could make it more difficult for a third party to acquire us, even though such acquisitions
may be beneficial to our stockholders. These anti-takeover provisions include:
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establishment of a classified board of directors such that not all members of the
board may be elected at one time; |
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|
lack of a provision for cumulative voting in the election of directors, which would
otherwise allow less than a majority of stockholders to elect director candidates; |
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|
the ability of our board to authorize the issuance of blank check preferred stock
to increase the number of outstanding shares and thwart a takeover attempt; |
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prohibition on stockholder action by written consent, thereby requiring all
stockholder actions to be taken at a meeting of stockholders; |
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|
establishment of advance notice requirements for nominations for election to the
board of directors or for proposing matters that can be acted upon by stockholders at
stockholder meetings; and |
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limitations on who may call a special meeting of stockholders. |
Further, we have in place a preferred share purchase rights plan, commonly known as a poison
pill. The provisions described above, our poison pill and provisions of Delaware law relating to
business combinations with interested stockholders may discourage, delay or prevent a third party
from acquiring us. These provisions may also discourage, delay or prevent a third party from
acquiring a large portion of our securities or initiating a tender offer or proxy contest, even if
our stockholders might receive a premium for their shares in the acquisition over the then current
market prices. We also have a change of control severance benefits plan which provides for certain
cash severance, stock award acceleration and other benefits in the event our employees are
terminated (or, in some cases, resign for specified reasons) following an acquisition. This
severance plan could discourage a third party from acquiring us.
31
Risks Related to Our Securities
The price of our common stock and senior convertible debt are expected to remain volatile.
Our stock price is volatile. During the year ended December 31, 2008, based on closing bid
prices on the NASDAQ Global Select Market, our stock price ranged from $2.83 to $7.50 per share. We
expect our stock price to remain volatile. In addition, as our convertible senior notes are
convertible into shares of our common stock, volatility or depressed prices of our common stock
could have a similar effect on the trading price of our notes. Also, interest rate fluctuations can
affect the price of our convertible senior notes. A variety of factors may have a significant
effect on the market price of our common stock or notes, including:
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announcements of data from, or material developments in, our clinical trials or those
of our competitors, including delays in clinical development, approval or launch; |
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|
|
announcements by collaboration partners as to their plans or expectations related to
products using our technologies; |
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|
announcements or terminations of collaborative relationships by us or our
competitors; |
|
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|
fluctuations in our results of operations; |
|
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|
developments in patent or other proprietary rights, including intellectual property
litigation or entering into intellectual property license agreements and the costs
associated with those arrangements; |
|
|
|
announcements of technological innovations or new therapeutic products that may
compete with our approved products or products under development; |
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|
announcements of changes in governmental regulation affecting us or our competitors; |
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|
hedging activities by purchasers of our convertible senior notes; |
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|
litigation brought against us or third parties to whom we have indemnification
obligations; |
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public concern as to the safety of drug formulations developed by us or others; and |
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general market conditions. |
Our stockholders may be diluted, and the price of our common stock may decrease, as a result of the
exercise of outstanding stock options and warrants or the future issuances of securities.
We may issue additional common stock, preferred stock, restricted stock units or securities
convertible into or exchangeable for our common stock. Furthermore, substantially all shares of
common stock for which our outstanding stock options or warrants are exercisable are, once they
have been purchased, eligible for immediate sale in the public market. The issuance of additional
common stock, preferred stock, restricted stock units or securities convertible into or
exchangeable for our common stock or the exercise of stock options or warrants would dilute
existing investors and could adversely affect the price of our securities.
Item 1B. Unresolved Staff Comments
None.
Item 2. Properties
We currently lease approximately 100,000 square feet of facilities in San Carlos, California
under a capital lease which expires in 2016. The San Carlos facility is home to our administrative
headquarters, as well as research and development for our PEGylation and advanced polymer conjugate
technology operations. Until December 31, 2008, we leased approximately 230,000 additional square
feet in San Carlos, which housed our pulmonary manufacturing facility, as well as research and
development laboratories and administrative offices, under a lease which expired in 2012. This
lease was assigned to Novartis Pharmaceuticals Corporation in connection with our sale to Novartis
of certain of our pulmonary assets on December 31, 2008.
We currently own two facilities consisting of 145,000 square feet in Huntsville, Alabama,
which house laboratories as well as administrative, commercial and clinical manufacturing
facilities for our PEGylation and advanced polymer conjugate technology operations. Additionally,
we lease 18,000 square feet of facilities in Hyderabad, India under various operating leases, with
expiration dates ranging from 2009 to 2011. The Hyderabad facilities are used for research and
development activities. We are currently constructing an 80,000 square foot research and
development facility near Hyderabad, India. We expect to complete construction of this facility by
the end of 2009.
32
Item 3. Legal Proceedings
On June 30, 2006, we, our subsidiary Nektar AL, and a former officer, Milton Harris, entered
into a settlement agreement and general release with the University of Alabama Huntsville (UAH)
related to an intellectual property dispute. Under the terms of the settlement agreement, we,
Nektar AL, Mr. Harris and UAH agreed to full and complete satisfaction of all claims asserted in
the litigation in exchange for $25.0 million in cash payments. We and Mr. Harris made an initial
payment of $15.0 million on June 30, 2006, of which we paid $11.0 million and Mr. Harris paid $4.0
million. During the year ended December 31, 2006, we recorded a litigation settlement charge of
$17.7 million, which reflects the net present value of the settlement payments using an 8% annual
discount rate. We made payments of $1.0 million in June 2007 and June 2008, respectively. As of
December 31, 2008 and 2007, our accrued liability related to the UAH settlement was $6.0 million
and $6.5 million, respectively.
In addition, from time to time, we may be subject to other legal proceedings and claims in the
ordinary course of business. We are not aware of any such proceedings or claims that we believe
will have, individually or in the aggregate, a material adverse effect on our business, financial
condition or results of operations.
Item 4. Submission of Matters to a Vote of Security Holders
No matters were submitted to a vote of our security holders in the three-month period ended
December 31, 2008.
PART II
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Item 5. |
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Market for Registrants Common Equity Related Stockholder Matters and Issuer Purchases of
Equity Securities |
Our common stock trades on the NASDAQ Global Select Market under the symbol NKTR. The table
below sets forth the high and low closing sales prices for our common stock as reported on the
NASDAQ Global Select Market during the periods indicated.
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High |
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Low |
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Year Ended December 31, 2007: |
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|
|
|
|
|
1st Quarter |
|
$ |
15.24 |
|
|
$ |
11.20 |
|
2nd Quarter |
|
|
13.58 |
|
|
|
9.32 |
|
3rd Quarter |
|
|
9.75 |
|
|
|
7.63 |
|
4th Quarter |
|
|
8.98 |
|
|
|
5.22 |
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|
|
|
|
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|
Year Ended December 31, 2008: |
|
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|
|
|
|
|
1st Quarter |
|
$ |
7.50 |
|
|
$ |
6.12 |
|
2nd Quarter |
|
|
7.35 |
|
|
|
3.35 |
|
3rd Quarter |
|
|
5.36 |
|
|
|
3.10 |
|
4th Quarter |
|
|
5.97 |
|
|
|
2.83 |
|
Holders of Record
As of February 27, 2009, there were approximately 301 holders of record of our common stock.
Dividend Policy
We have never declared or paid any cash dividends on our common stock. We currently expect to
retain any future earnings for use in the operation and expansion of our business and do not
anticipate paying any cash dividends on our common stock in the foreseeable future.
There were no sales of unregistered securities and there were no common stock repurchases made
during the year ended December 31, 2008.
33
Securities Authorized for Issuance Under Equity Compensation Plans
Information regarding our equity compensation plans as of December 31, 2008 is disclosed in
Item 12 Security Ownership of Certain Beneficial Owners and Management and Related Stockholder
Matters of this Annual Report on Form 10-K and is incorporated herein by reference from our proxy
statement for our 2009 annual meeting of stockholders to be filed with the SEC pursuant to
Regulation 14A not later than 120 days after the end of the fiscal year covered by this Annual
Report on Form 10-K.
Performance Measurement Comparison
The material in this section is being furnished and shall not be deemed filed with the SEC
for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that
section, nor shall the material in this section be deemed to be incorporated by reference in any
registration statement or other document filed with the SEC under the Securities Act or the
Exchange Act, except as otherwise expressly stated in such filing.
The following graph compares, for the five year period ended December 31, 2008, the cumulative
total stockholder return (change in stock price plus reinvested dividends) of our common stock with
(i) the NASDAQ Composite Index, (ii) the NASDAQ Pharmaceutical Index, (iii) the RGD SmallCap
Pharmaceutical Index, (iv) the NASDAQ Biotechnology Index and (v) the RDG SmallCap Biotechnology
Index. Measurement points are the last trading day of each of our fiscal years ended December 31,
2003, December 31, 2004, December 31, 2005, December 31, 2006, December 31, 2007 and December 31,
2008. The graph assumes that $100 was invested on December 31, 2003 in the common stock of the
Company, the NASDAQ Composite Index, the Nasdaq Pharmaceutical Index, the RGD SmallCap
Pharmaceutical Index, the NASDAQ Biotechnology Index and the RDG SmallCap Biotechnology Index and
assumes reinvestment of any dividends. The stock price performance in the graph is not intended to
forecast or indicate future stock price performance.
34
Item 6. Selected Financial Data
SELECTED CONSOLIDATED FINANCIAL INFORMATION
(In thousands, except per share information)
The selected consolidated financial data set forth below should be read together with the
consolidated financial statements and related notes, Managements Discussion and Analysis of
Financial Condition and Results of Operations, and the other information contained herein.
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Years ended December 31, |
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2008 |
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
|
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|
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Statements of Operations Data: |
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Revenue: |
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|
|
|
|
|
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|
|
|
|
|
|
|
|
Product sales and royalties (1) |
|
$ |
41,255 |
|
|
$ |
180,755 |
|
|
$ |
153,556 |
|
|
$ |
29,366 |
|
|
$ |
25,085 |
|
Collaboration and other (2) |
|
|
48,930 |
|
|
|
92,272 |
|
|
|
64,162 |
|
|
|
96,913 |
|
|
|
89,185 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
|
90,185 |
|
|
|
273,027 |
|
|
|
217, 718 |
|
|
|
126,279 |
|
|
|
114,270 |
|
Total operating costs and expenses (3)(4) |
|
|
172,837 |
|
|
|
309,175 |
|
|
|
376,948 |
|
|
|
308,912 |
|
|
|
188,212 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Loss from operations |
|
|
(82,652 |
) |
|
|
(36,148 |
) |
|
|
(159,230 |
) |
|
|
(182,633 |
) |
|
|
(73,942 |
) |
Gain (loss) on debt extinguishment |
|
|
50,149 |
|
|
|
|
|
|
|
|
|
|
|
(303 |
) |
|
|
(9,258 |
) |
Interest and other income (expense), net |
|
|
(2,639 |
) |
|
|
4,696 |
|
|
|
5,297 |
|
|
|
(2,312 |
) |
|
|
(18,849 |
) |
Provision (benefit) for income taxes |
|
|
(806 |
) |
|
|
1,309 |
|
|
|
828 |
|
|
|
(137 |
) |
|
|
(163 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(34,336 |
) |
|
$ |
(32,761 |
) |
|
$ |
(154,761 |
) |
|
$ |
(185,111 |
) |
|
$ |
(101,886 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share (5) |
|
$ |
(.37 |
) |
|
$ |
(0.36 |
) |
|
$ |
(1.72 |
) |
|
$ |
(2.15 |
) |
|
$ |
(1.30 |
) |
Shares used in computing basic and
diluted net loss per share (5) |
|
|
92,407 |
|
|
|
91,876 |
|
|
|
89,789 |
|
|
|
85,915 |
|
|
|
78,461 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
|
Balance Sheet Data: |
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|
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|
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|
|
|
|
|
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|
|
|
|
|
|
|
|
Cash, cash equivalents and
investments |
|
$ |
378,994 |
|
|
$ |
482,353 |
|
|
$ |
466,977 |
|
|
$ |
566,423 |
|
|
$ |
418,740 |
|
Working capital |
|
$ |
337,846 |
|
|
$ |
425,191 |
|
|
$ |
369,457 |
|
|
$ |
450,248 |
|
|
$ |
223,880 |
|
Total assets |
|
$ |
560,536 |
|
|
$ |
725,103 |
|
|
$ |
768,177 |
|
|
$ |
858,554 |
|
|
$ |
744,921 |
|
Deferred revenue |
|
$ |
65,577 |
|
|
$ |
80,969 |
|
|
$ |
40,106 |
|
|
$ |
23,861 |
|
|
$ |
31,021 |
|
Convertible subordinated notes |
|
$ |
214,955 |
|
|
$ |
315,000 |
|
|
$ |
417,653 |
|
|
$ |
417,653 |
|
|
$ |
173,949 |
|
Other long-term liabilities |
|
$ |
25,585 |
|
|
$ |
27,543 |
|
|
$ |
29,189 |
|
|
$ |
27,598 |
|
|
$ |
36,250 |
|
Accumulated deficit |
|
$ |
(1,124,090 |
) |
|
$ |
(1,089,754 |
) |
|
$ |
(1,056,993 |
) |
|
$ |
(902,232 |
) |
|
$ |
(717,121 |
) |
Total stockholders equity |
|
$ |
190,154 |
|
|
$ |
214,439 |
|
|
$ |
227, 060 |
|
|
$ |
326,811 |
|
|
$ |
467,342 |
|
|
|
|
(1) |
|
2006 and 2007 product sales and royalties include commercial manufacturing revenue from
Exubera bulk dry powder insulin and Exubera inhalers. |
|
(2) |
|
2007, 2006, and 2005 collaboration and other revenue included Exubera commercialization
readiness revenue. |
|
(3) |
|
We changed our method of accounting for stock based compensation on January 1, 2006 in
connection with the adoption of SFAS No. 123R, Share-Based Payment. |
|
(4) |
|
Operating costs and expenses includes the Gain on sale of pulmonary assets of $69.6 million
in 2008 and the Gain on termination of collaborative agreements, net of $79.2 million in 2007. |
|
(5) |
|
Basic and diluted net loss per share is based upon the weighted average number of common
shares outstanding. |
35
Item 7. Managements Discussion and Analysis of Financial Condition and Results of Operations
The following discussion contains forward-looking statements that involve risks and
uncertainties. Our actual results could differ materially from those discussed here. Factors that
could cause or contribute to such differences include, but are not limited to, those discussed in
this section as well as factors described in Part I, Item 1ARisk Factors.
Overview
Strategic Direction of Our Business
We are a clinical-stage biopharmaceutical company developing a pipeline of drug candidates
that utilize our PEGylation and advanced polymer conjugate technology platforms to improve the
therapeutic benefits of drugs. Our proprietary product pipeline is comprised of drug candidates
across a number of therapeutic areas, including oncology, pain, anti-infectives and immunology. We
create our innovative product candidates by using our proprietary chemistry platform to modify the
chemical structure of drugs using unique polymer conjugates. Additionally, we may utilize
established pharmacologic targets to engineer a new drug candidate relying on a combination of the
known properties of these targets and the attributes of our customized polymer chemistry. Our drug
candidates are designed to correct deficiencies in the pharmacokinetics, half-life, oral
bioavailability, metabolism or distribution of drugs to improve their therapeutic efficacy.
During 2009, we expect to continue to make substantial investments to advance our pipeline of
drug candidates from early stage discovery research through clinical
development. On March 2, 2009, we
announced that we were terminating our Phase 2 clinical trial for Oral NKTR-118 (oral PEGylated
naloxol) as a result of positive preliminary results. We also have several Phase 2 clinical trials
for NKTR-102 (PEGylated irinotecan) directed at a number of different indications in the oncology
therapeutic area already underway or scheduled to begin during 2009. In addition, on February 17,
2009, we announced that we had dosed the first patient in a Phase 1 clinical trial for NKTR-105
(PEGylated docetaxel) for patients with refractory solid tumors. We also have several other
products in the early discovery or preclinical stage that we are preparing to move into clinical
development or will be moving into clinical development in 2009.
Our focus on research and clinical development requires substantial investments that continue
to increase as we advance each drug candidate through the development cycle. While we believe that
our strategy has the potential to create significant value if one or more of our drug candidates
demonstrates positive clinical results and/or receives regulatory approval in one or more major
markets, drug development is an inherently uncertain process and there is a high risk of failure at
every stage prior to approval and clinical results are very difficult to predict. Clinical
development success and failures can have an unpredictable and disproportionate positive or
negative impact on our scientific and medical prospects, financial prospects, financial condition,
and market value.
We intend to decide on a product-by-product basis whether we wish to continue development into
Phase 3 pivotal clinical trials and commercialize products on our own, or seek a partner, or pursue
a combination of these approaches. Following completion of Phase 2 development, or earlier in the
development cycle in certain circumstances, we will generally be seeking collaborations with one or
more biotechnology or pharmaceutical companies to conduct Phase 3 clinical development, to be
responsible for the regulatory approval process and, if such drug candidate is approved, to market
and sell the drug in one or more world markets. The commercial terms of such future
collaborations, if any, including, without limitation, up-front payments, development milestone
payments, and royalty rates, will be critical to the future prospects of our business and financial
condition. In particular, our ability to successfully conclude a new collaboration for Oral
NKTR-118 on commercially favorable terms (or at all), will have a significant impact on our financial position
and business prospects in 2009.
We also have a number of existing license and collaboration agreements with third parties who
have licensed our proprietary technologies for drugs that have either received regulatory approval
in one or more markets or drug candidates that are still in the clinical development stage. For
example, the future clinical and commercial success of Bayers Amikacin Inhale (BAY41-6551 or
NKTR-061), UCBs CIMZIA, Roches MIRCERA and Affymaxs Hematide, among others, will together have
a material impact on our long-term revenue prospects, as will the success of Bayers Cipro Inhale
program, in relation to which we have certain royalty rights. Because drug development and
commercialization is subject to a number of risks and uncertainties, there is a risk that our
future revenue from one or more of these agreements will be less than we anticipate.
36
We Exited the Inhaled Insulin Drug Programs in 2008
In 1995, we entered into a collaborative development and licensing agreement with Pfizer to
develop and market dry powder inhaled insulin (Exubera) for patients with diabetes. In 2006 and
2007, we entered into a series of interim letter agreements with Pfizer to develop a next generation form of dry powder inhaled insulin (NGI).
In January 2006, Exubera received marketing approval in the U.S. and EU. Under the collaborative
development and licensing agreement, Pfizer had sole responsibility for marketing and selling
Exubera. We performed all of the manufacturing of the bulk dry powder insulin, and through our
third party contract manufacturers Bespak Europe Ltd. and Tech Group North America, Inc., we
supplied Pfizer with the Exubera inhalers. Our total revenue from Pfizer was nil, $189.1 million,
and $139.9 million, representing 0%, 69%, and 64% of total revenue, for the years ended December
31, 2008, 2007, and 2006, respectively.
On October 18, 2007, Pfizer announced that it was exiting the Exubera and inhaled insulin
development and gave notice of termination under our collaborative development and licensing
agreement. On November 9, 2007, we entered into a termination agreement and mutual release with
Pfizer. Under this agreement we received a one-time payment of $135.0 million from Pfizer in
November 2007 in satisfaction of all outstanding contractual obligations under our then-existing
agreements relating to Exubera and NGI. All agreements between Pfizer and us related to Exubera
and NGI, other than the termination agreement and mutual release and a related interim Exubera
manufacturing maintenance letter, terminated on November 9, 2007. In February 2008, we entered
into a manufacturing termination agreement with Bespak and Tech Group pursuant to which we paid an
aggregate of $39.9 million in satisfaction of outstanding accounts payable and termination costs
and expenses that were due to the contract manufacturers under the Exubera inhaler contract
manufacturing agreement. We also entered into a maintenance agreement with both Pfizer and Tech
Group to preserve key personnel and manufacturing capacity to support potential future Exubera
manufacturing if we were successful in finding a new partner for the inhaled insulin program.
On April 9, 2008, we announced that we had ceased all negotiations with potential partners for
Exubera and NGI as a result of new data analysis from ongoing clinical trials conducted by Pfizer
which indicated an increase in the number of new cases of lung cancer in Exubera patients who were
former smokers as compared to patients in the control group who were not former smokers. In April
2008, we ceased all spending associated with maintaining Exubera manufacturing capacity and any
further NGI development, including, but not limited to, terminating the Exubera manufacturing
capacity maintenance arrangements with Pfizer and Tech Group.
We Completed the Sale of Certain Pulmonary Assets and Operations at the End of 2008
On December 31, 2008, we completed the sale of certain assets related to our pulmonary
business, associated technology and intellectual property to Novartis Pharma AG and Novartis
Pharmaceuticals Corporation (together referred to as Novartis) for a purchase price of $115.0
million in cash (Novartis Pulmonary Asset Sale). Pursuant to the asset purchase agreement entered
between Novartis and us, we transferred to Novartis assets and obligations which include certain
dry powder and liquid pulmonary formulation and manufacturing assets, including capital equipment
and manufacturing facility lease obligations, certain intellectual property and manufacturing
methods and associated information systems related to the pulmonary business, and certain other
interests in two private companies, and Novartis hired approximately 140 of our pulmonary
personnel. In addition, we assigned our rights and obligations, other than certain royalty rights,
related to the Cipro Inhale partnered with Bayer Schering Pharma AG to Novartis, and terminated our
collaborative research, development, and commercialization agreement related to the Tobramycin
inhalation powder (TIP) program with Novartis Vaccines and Diagnostics, Inc. Pursuant to the asset
purchase agreement, we retain our rights and obligations under our co-development, license and
co-promotion agreement with Bayer Healthcare LLC related to BAY41-6551 (NKTR-061, Amikacin Inhale),
our development program related to NKTR-063 (Inhaled Vancomycin) and intellectual property specific
to inhaled insulin. Although we completed the Novartis Pulmonary Asset Sale on December 31, 2008,
we will pay approximately $4.4 million in related transaction costs in the three months ended March
31, 2009, including legal fees, investment banker fees, and other costs.
Following the completion of the Novartis transaction, we expect our contract research revenue
and total revenue to significantly decline in 2009 due to the termination of the inhaled TIP
collaboration agreement with Novartis Vaccines and Diagnostics, Inc. and our assignment and
transfer of our inhaled Cipro Inhale collaboration agreement with Bayer Schering Pharma AG to
Novartis. Our collaboration revenue related to TIP and Cipro Inhale was $13.7 million and $11.7
million, or 15% and 13%, respectively, of our total revenue for the year ended December 31, 2008.
We will not receive any revenue from these programs in 2009. However, also following the Novartis
transaction, we will no longer incur expenses from the approximately 140 pulmonary personnel and
the dedicated pulmonary manufacturing facility, as well as certain other costs related to the
assets and obligations, transferred to Novartis. The only future research and development
obligations associated with the pulmonary assets that we retained in relation to the Novartis
transaction relate to BAY41-66551 and NKTR-063. Under our collaboration agreement with Bayer
Healthcare LLC, we are responsible for the completion of final device development and have a
reimbursement obligation for up to $10.0 million of Phase 3 development costs incurred by Bayer
Healthcare LLC.
37
Key Developments and Trends in Liquidity and Capital Resources
At December 31, 2008, we had approximately $379.0 million in cash and cash equivalents and
$242.6 million in indebtedness. In the three months ended December 31, 2008, we repurchased
approximately $100.0 million in par value of our 3.25% convertible subordinated notes for an
aggregate purchase price of $47.8 million. We may from time to time purchase or retire additional
convertible subordinated notes through cash purchase or exchanges for other securities of the
Company in open market or privately negotiated transactions, depending on, among other factors, our
levels of available cash and the price at which such convertible notes are available for purchase.
We will evaluate such transactions, if any, in light of then-existing market conditions. These
transactions, individually or in the aggregate, may be material to our business.
We have financed our operations primarily through revenue from product sales and royalties and
research and development contracts and public and private placements of debt and equity. To date
we have incurred substantial debt as a result of our issuances of subordinated notes that are
convertible into our common stock. Our substantial debt, the market price of our securities, and
the general economic climate, among other factors, could have material consequences for our
financial condition and could affect our sources of short-term and long-term funding. Our ability
to meet our ongoing operating expenses and repay our outstanding indebtedness is dependent upon our
and our partners ability to successfully complete clinical development of, obtain regulatory
approvals for and successfully commercialize new drugs. Even if we or our partners are successful,
we may require additional capital to continue to fund our operations and repay our debt obligations
as they become due. There can be no assurance that additional funds, if and when required, will be
available to us on favorable terms, if at all.
For the year ended December 31, 2008, net cash used for our operating activities was $145.8
million. During the year ended December 31, 2008, we made the following payments, among others:
(i) $39.9 million to Bespak Europe Ltd. and Tech Group as payment for termination amounts due under
our Exubera inhaler manufacturing and supply agreement with those companies, all of which was
recorded as an expense in 2007, (ii) $6.8 million to maintain Exubera manufacturing capacity
through April 2008 and (iii) $5.4 million for severance, employee benefits and outplacement
services in connection with our workforce reduction plans. We do not anticipate incurring any
costs in 2009 associated with inhaled insulin.
Our substantial investment in our preclinical and clinical research and any potential new
licensing or partnership agreements, if any, will be the key drivers of our results of operations
and financial position during 2009. One of our collaboration partners has a one-time license
extension option exercisable in December 2009. If this partner elects to exercise this license
extension option right, we will receive a cash payment of $31.0 million in December 2009.
Results of Operations
Years Ended December 31, 2008, 2007, and 2006
Revenue (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
Product sales and
royalties |
|
$ |
41,255 |
|
|
$ |
180,755 |
|
|
$ |
153,556 |
|
|
$ |
(139,500 |
) |
|
$ |
27,199 |
|
|
|
(77 |
)% |
|
|
18 |
% |
Collaboration and other |
|
|
48,930 |
|
|
|
92,272 |
|
|
|
64,162 |
|
|
|
(43,342 |
) |
|
|
28,110 |
|
|
|
(47 |
)% |
|
|
44 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Revenue |
|
$ |
90,185 |
|
|
$ |
273,027 |
|
|
$ |
217,718 |
|
|
$ |
(182,842 |
) |
|
$ |
55,309 |
|
|
|
(67 |
)% |
|
|
25 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During the year ended December 31, 2008, the decrease in total revenue from the year ended
December 31, 2007 was primarily attributable to the termination of our collaboration agreements
with Pfizer related to Exubera and NGI, which accounted for $182.4 million, or 67%, of our total
revenue during the year ended December 31, 2007. We had no revenue from Pfizer related to Exubera
or NGI for the year ended December 31, 2008. Four of our customers, Bayer (including Bayer
Healthcare LLC and Bayer Schering Pharma AG), UCB Pharma, Novartis, and Roche represented 24%, 16%,
15%, and 14%, respectively, of our total revenue during the year ended December 31, 2008.
In connection with the completion of the Novartis Pulmonary Asset Sale on December 31, 2008,
our collaboration agreement with Novartis Vaccines and Diagnostics, Inc. for TIP was terminated and
our collaboration agreement with Bayer Schering Pharma AG for Cipro Inhale was assigned to
Novartis. Collaboration revenue related to TIP and Cipro Inhale was $13.7 million and $11.7
million, or 15% and 13%, of our total revenue for the year ended December 31, 2008. We will not
receive any revenue related to these programs in 2009. While we may enter new collaboration or
license agreements in 2009,
we expect revenue to decrease in 2009 as a result of the TIP agreement termination, the
assignment of the Cipro Inhale agreement, and lower product sales volumes required by our licensing
partners. In addition, if our collaboration partner elects not to exercise its one-time license
extension option in December 2009 and pay us the one-time $31.0 million license fee for such
option, our revenue would significantly decrease in 2009 as compared to the year ended December 31,
2008.
38
Product sales and royalties
For the year ended December 31, 2007, Exubera product sales to Pfizer accounted for $132.9
million of our total revenue. We had no revenue from Pfizer related to Exubera for the year ended
December 31, 2008. Non-Exubera product sales and royalties decreased by approximately $6.6 million,
or 14%, for the year ended December 31, 2008, compared to the year ended December 31, 2007. The
decrease in non-Exubera product sales and royalties is primarily attributable to the November 30,
2007 sale of Aerogen Ireland Ltd., one of our former subsidiaries that manufactured and supplied
general purpose nebulizer devices, which accounted for $5.5 million in revenue for the year ended
December 31, 2007.
Product sales and royalties increased 18% to $180.8 million for the year ended December 31,
2007 as compared to the year ended December 31, 2006. Exubera product sales to Pfizer increased by
approximately $32.0 million during the year ended December 31, 2007 as compared to the year ended
December 31, 2006. Exubera commercial sales began in January 2006. During the year ended December
31, 2006, we deferred recognition of all Exubera product sales until Pfizers contractual 60-day
right of return period lapsed. As a result, as of December 31, 2006, we deferred $22.9 million in
Exubera product sales and we recognized ten months of product shipments in revenue. In January
2007, we began estimating product warranty returns and recognizing Exubera product sales upon
shipment. During the year ended December 31, 2007, we recognized product sales through November 9,
2007, when our collaboration agreements with Pfizer terminated, as well as the revenue deferred at
December 31, 2006.
Royalty revenues were $3.5 million, $3.7 million, and $9.2 million for the years ended
December 31, 2008, 2007, and 2006, respectively.
Collaboration and other revenue
Collaboration and other revenue includes reimbursed research and development expenses,
amortization of deferred up-front signing and milestone payments received from our collaboration
partners, and intellectual property license fee revenue. Collaboration revenue fluctuates from year
to year, and therefore future collaboration revenue cannot be predicted accurately. The level of
collaboration and other revenues depends in part upon the continuation of existing collaborations,
signing of new collaborations, the stage of program development, and the achievement of milestones.
For the year ended December 31, 2007, collaboration and other revenue from Pfizer related to
Exubera and NGI accounted for $49.5 million of our collaboration and other revenue. We had no
collaboration and other revenue from Pfizer related to Exubera or NGI for the year ended December
31, 2008. The increase in non-Pfizer collaboration and other revenue of $6.1 million during the
year ended December 31, 2008 compared to the year ended December 31, 2007 is primarily attributable
to a new intellectual property license agreement we entered into with F. Hoffmann-La Roche Ltd. For
the year ended December 31, 2008, we have recognized increased collaboration and other revenue from
Bayer (including Bayer Healthcare LLC and Bayer Schering Pharma AG) of $12.3 million under our
collaboration agreements for BAY41-6551 (NKTR-061, Amikacin Inhale) and Cipro Inhale. These
increases are offset by decreased collaboration and other revenue of $3.3 million from Novartis
Vaccines and Diagnostics, Inc. under our collaboration agreement for TIP and of $3.7 million from
Solvay Pharmaceuticals, Inc. and Zelos Therapeutics Inc. following the termination of those
collaboration agreements in 2008.
The increase in collaboration and other revenue for the year ended December 31, 2007 compared
to the year ended December 31, 2006 is primarily attributable to increased revenue from Pfizer of
$15.8 million, which includes recognition of $24.6 million in NGI up-front fees upon termination of
the Pfizer Agreements. Additionally, collaboration and other revenue from Novartis increased by
$8.5 million under our collaboration agreement for TIP, and Bayer (including Bayer Healthcare LLC
and Bayer Schering Pharma AG) increased by $3.2 million, and $1.3 million, respectively, under our
collaboration agreements for Cipro Inhale and BAY41-6551, respectively. These increases in
collaboration and other revenue were partially offset by decreased revenue from Zelos of $4.2
million under our collaboration agreement to develop Ostabolin-C.
The timing and future success of our drug development programs and those of our collaboration
partners are subject to a number of risks and uncertainties. See Part I, Item 1ARisk Factors
for discussion of the risks associated with our partnered research and development programs.
39
Revenue by geography
Revenue by geographic area is based on the shipping locations of our customers. The following
table sets forth revenue by geographic area (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
United States |
|
$ |
30,800 |
|
|
$ |
212,990 |
|
|
$ |
182,959 |
|
European countries |
|
|
59,385 |
|
|
|
60,037 |
|
|
|
33,471 |
|
All other countries |
|
|
|
|
|
|
|
|
|
|
1,288 |
|
|
|
|
|
|
|
|
|
|
|
Total Revenue |
|
$ |
90,185 |
|
|
$ |
273,027 |
|
|
$ |
217,718 |
|
|
|
|
|
|
|
|
|
|
|
The decrease in revenue attributable to the United States for the year ended December 31, 2008
compared to the year ended December 31, 2007 is primarily attributable to our receipt of no revenue
from Pfizer related to Exubera for the year ended December 31, 2008.
The increase in revenue attributable to the United States for the year ended December 31, 2007
compared to the year ended December 31, 2006 is primarily attributable to the increase in revenue
from Pfizer related to Exubera for the year ended December 31, 2007. The increase in revenue
attributable to European countries for the year ended December 31, 2007 compared to the year ended
December 31, 2006 is primarily due to the increase in revenue from Novartis under our collaborative
agreement for TIP and from Bayer (including Bayer Healthcare LLC and Bayer Schering Pharma AG)
under our collaborative agreements for BAY41-6551 and Cipro Inhale.
Cost of goods sold (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
Cost of goods sold |
|
$ |
28,216 |
|
|
$ |
137,696 |
|
|
$ |
113,921 |
|
|
$ |
(109,480 |
) |
|
$ |
23,775 |
|
|
|
(80 |
)% |
|
|
21 |
% |
Product gross margin |
|
|
13,039 |
|
|
|
43,059 |
|
|
|
39,635 |
|
|
|
(30,020 |
) |
|
|
3,424 |
|
|
|
(70 |
)% |
|
|
9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product gross
margin % |
|
|
32 |
% |
|
|
24 |
% |
|
|
26 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The decrease in cost of goods sold and product gross margin during the year ended December 31,
2008 compared to the year ended December 31, 2007 was primarily due to the termination of our
agreements with Pfizer related to Exubera. During the year ended December 31, 2007, Exubera cost
of goods sold totaled $103.6 million and Exubera gross margin totaled $29.3 million. The increase
in product gross margin percentage is attributable to the change in product mix with our product
sales based on our PEGylation and advanced polymer conjugate technologies which have a relatively
higher gross margin.
Cost of goods sold during the year ended December 31, 2007 includes Exubera manufacturing
costs through the November 9, 2007 termination of the Pfizer agreements. Costs related to our
Exubera manufacturing operations after November 9, 2007 are included in other cost of revenue.
The increase in cost of goods sold and product gross margin during the year ended December 31,
2007 compared to the year ended December 31, 2006 is consistent with the proportionate increase in
Exubera product sales, which contributed $19.5 million to our product gross margin during the year
ended December 31, 2006. The decrease in gross margin percentage during the year ended December 31,
2007 compared to the year ended December 31, 2006 is primarily attributable to product mix, the
terms of our cost plus manufacturing arrangement with Pfizer, and the decline in royalty revenue of
$5.5 million during 2007.
We expect Cost of goods sold and Product gross margin to decline in 2009 as compared to the
year ended December 31, 2008 in connection with the lower manufacturing requirements forecasted by
our licensing partners.
40
Cost of Workforce Reduction Plans (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
Cost of goods sold, net of change
in inventory |
|
$ |
148 |
|
|
$ |
974 |
|
|
$ |
|
|
|
$ |
(826 |
) |
|
$ |
974 |
|
|
|
(85 |
%) |
|
|
n/a |
|
Other cost of revenue |
|
|
1,221 |
|
|
|
|
|
|
|
|
|
|
|
1,221 |
|
|
|
|
|
|
|
n/a |
|
|
|
n/a |
|
Research and development |
|
|
3,087 |
|
|
|
5,791 |
|
|
|
|
|
|
|
(2,704 |
) |
|
|
5,791 |
|
|
|
(47 |
%) |
|
|
n/a |
|
General and administrative |
|
|
517 |
|
|
|
1,617 |
|
|
|
|
|
|
|
(1,100 |
) |
|
|
1,617 |
|
|
|
(68 |
%) |
|
|
n/a |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of workforce reduction plans |
|
$ |
4,973 |
|
|
$ |
8,382 |
|
|
$ |
|
|
|
$ |
(3,409 |
) |
|
$ |
8,382 |
|
|
|
(41 |
%) |
|
|
n/a |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We executed workforce reduction plans in May 2007 (2007 Plan) and February 2008 (2008 Plan)
designed to streamline the company, consolidate corporate functions, and strengthen decision
making. The total cost of the 2007 Plan was $8.4 million and the total cost of the 2008 Plan was
$5.0 million, comprised of cash payments for severance, medical insurance and outplacement
services. Both plans were substantially complete at December 31, 2008. We have already begun to
realize the cost savings related to these two plans, as discussed further under Research and
development and General and administrative below.
Other cost of revenue (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
Other cost of revenue |
|
$ |
6,821 |
|
|
$ |
9,821 |
|
|
$ |
4,168 |
|
|
$ |
(3,000 |
) |
|
$ |
(5,653 |
) |
|
|
(31 |
%) |
|
|
>(100 |
%) |
Other cost of revenue includes the idle Exubera manufacturing capacity costs and Exubera
commercialization readiness costs that were incurred by us prior to the termination of all of our
inhaled insulin programs in April 2008.
Idle Exubera manufacturing capacity costs includes the costs of maintaining our manufacturing
operating capacity after the termination of the Pfizer agreements on November 9, 2007 through the
termination of our inhaled insulin programs on April 9, 2008. Idle Exubera manufacturing capacity
costs include amounts payable to Pfizer and Tech Group under interim manufacturing capacity
maintenance agreements and an allocation of manufacturing costs shared between commercial
operations and research and development, including employee compensation and benefits, rent, and
utilities. Idle Exubera manufacturing costs were $6.8 million, $6.3 million, and nil for the year
ended December 31, 2008, 2007, and 2006, respectively.
Exubera commercialization readiness costs were start-up manufacturing costs we incurred in our
Exubera inhalation bulk powder manufacturing facility and our Exubera inhaler device third party
contract manufacturing locations in preparation for commercial scale manufacturing in early 2006.
Exubera commercialization readiness costs were nil, $3.5 million, and $4.2 million for the year
ended December 31, 2008, 2007, and 2006, respectively.
We do not expect to incur any additional idle Exubera manufacturing capacity or Exubera
commercialization readiness costs.
Research and development (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
Research &
development |
|
$ |
154,417 |
|
|
$ |
153,575 |
|
|
$ |
149,381 |
|
|
$ |
842 |
|
|
$ |
4,194 |
|
|
|
1 |
% |
|
|
3 |
% |
Research and development expenses consist primarily of personnel costs, including salaries,
benefits and stock-based compensation, clinical studies performed by contract research
organizations (CROs), materials and supplies, licenses and fees and overhead allocations consisting
of various support and facilities related costs. Our research and development activities are
broken down between proprietary and partnered drug development programs. Under the terms of our
collaboration agreements, we are generally reimbursed for research and development activities and
will receive milestones and royalties on commercial sales of the drug.
41
Research and development costs include certain allocations of resources shared across our
research and development programs, including facilities, manufacturing quality personnel and other
shared resources. We have generally allocated these shared costs based on personnel hours. The
costs incurred in connection with our research and development programs, is as follows (in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical |
|
Years ended December 31, |
|
|
|
Study
Status(1) |
|
2008 |
|
|
2007 |
|
|
2006 |
|
NKTR-102 (PEGylated irinotecan) |
|
Phase 2 |
|
$ |
24.2 |
|
|
$ |
12.7 |
|
|
$ |
2.7 |
|
NKTR-118 (oral PEGylated naloxol) |
|
Phase 2 |
|
|
24.6 |
|
|
|
12.9 |
|
|
|
5.5 |
|
Tobramycin inhalation powder (TIP)(2) |
|
Phase 2 |
|
|
19.7 |
|
|
|
16.3 |
|
|
|
12.8 |
|
BAY41-6551 (NKTR-061, Amikacin Inhale) (3) |
|
Phase 2 |
|
|
17.7 |
|
|
|
15.2 |
|
|
|
13.6 |
|
Cipro Inhale(4) |
|
Phase 2 |
|
|
11.4 |
|
|
|
8.3 |
|
|
|
5.9 |
|
NKTR-105 (PEGylated docetaxel) |
|
Phase 1 |
|
|
8.4 |
|
|
|
0.4 |
|
|
|
|
|
Inhaled Insulin(5) |
|
Discontinued |
|
|
3.5 |
|
|
|
37.6 |
|
|
|
39.5 |
|
NKTR-063 (Inhaled Vancomycin) |
|
Phase 1 |
|
|
2.3 |
|
|
|
|
|
|
|
|
|
Other PEGylation product candidates |
|
Various |
|
|
21.0 |
|
|
|
16.2 |
|
|
|
12.4 |
|
Other pulmonary product candidates(6) |
|
Various |
|
|
15.7 |
|
|
|
28.2 |
|
|
|
54.0 |
|
Other(7) |
|
|
|
|
5.9 |
|
|
|
5.8 |
|
|
|
3.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
|
$ |
154.4 |
|
|
$ |
153.6 |
|
|
$ |
149.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Clinical Study Status definitions are provided in the chart found in Part I, Item 1. Business |
|
(2) |
|
The collaboration agreement with Novartis Vaccines and Diagnostics, Inc. was terminated on December 31, 2008 in connection
with the Novartis Pulmonary Asset Sale. |
|
(3) |
|
Partnered with Bayer Healthcare LLC since August 2007. As part of the Novartis Pulmonary Asset Sale , we retained an exclusive
license to this technology for the development and commercialization of this product originally developed by Nektar. |
|
(4) |
|
The collaboration agreement with Bayer Schering Pharma AG was assigned to Novartis on December 31, 2008 in connection with
the Novartis Pulmonary Asset Sale. |
|
(5) |
|
Partnership for the collaboration and development of Exubera inhalation powder and the next generation inhaled insulin with
Pfizer was terminated on November 9, 2007. Inhaled insulin programs were terminated in April 2008. |
|
(6) |
|
Certain proprietary pulmonary intellectual property was transferred to Novartis as part of the Novartis Pulmonary Asset Sale. |
|
(7) |
|
Other includes additional costs related Novartis Pulmonary Asset Sale in 2008, workforce reduction charges in 2008 and 2007, and
research and development costs related to our ceased super-critical fluids business in 2006. |
Research and development expense remained at a consistent level in 2008 as compared to 2007
despite a significant increase in our investment in clinical development of our proprietary drug
candidates in 2008. This was a result of the continued transition of our business to focus on our
internal proprietary drug candidates in 2008 and a decrease in other research and development
activities.
Salaries, benefits, and stock-based compensation expense decreased by approximately $14.0
million for the year ended December 31, 2008 compared to the year ended December 31, 2007, as we
continued to realize the benefits of our workforce reduction plans executed in May 2007 and
February 2008. Facilities and equipment expense decreased by approximately $8.0 million primarily
as a result of lower depreciation due to the write-off of the Pfizer-related equipment in 2007 and
certain pulmonary property and equipment classified as held for sale at September 30, 2008. These
decreases were offset by increased costs related to our ongoing clinical trials for our proprietary
drug candidates, comprised increased outside services
of $13.4 million, including costs to CROs, and increased materials and supplies expense of
$8.2 million. During the year ended December 31, 2008, research and development expense included
approximately $2.7 million in additional costs related to the Novartis Pulmonary Asset Sale,
including one-time termination benefits and other costs.
During the year ended December 31, 2008, our research and development spending in our
partnered drug development programs decreased after the termination of our Pfizer agreements for
inhaled insulin in November 2007. Spending related to our proprietary drug development programs
increased as we continued to advance clinical development for NKTR-102, NKTR-118, and NKTR-105.
Research and development expense, excluding workforce reduction charges, decreased by
approximately $1.6 million during the year ended December 31, 2007, compared to the year ended
December 31, 2006. Research and development expense related to our drug candidates based on
PEGylation technology and advanced polymer conjugate technologies increased by approximately $21.6
million as a result of the completion of the Phase 1 clinical trials for NKTR-118 and NKTR-102 and
the commencement of Phase 2 clinical trials for these drug development programs. Pulmonary
research and development program expenses decreased by approximately $20.2 million as a result of a
$20.0 million decrease related to NKTR-024 and a $12.9 million decrease related to Exubera. These
decreases are partially offset by increased spending on NGI of $11.0 million, increased spending on
TIP of $3.5 million and increased spending on BAY41-6551 of approximately $1.6 million.
Additionally, we decreased spending on non-pulmonary and non-PEGylation programs by $3.0 million in
connection with the winding down of our Bradford, UK operations in 2006 which related to our
super-critical fluid technology.
42
We anticipate that our research and development expenses will decrease in the year ended
December 31, 2009 compared to the year ended December 31, 2008, which will be comprised of
decreases in our internal salaries, benefits, and facilities costs as a result of the Novartis
Pulmonary Asset Sale, partially offset by an increase in materials and supplies and third party
costs for our CROs as we continue to advance clinical trials for NKTR-102, NKTR-118, and NKTR-105.
The estimated completion dates for our programs are not reasonably certain. See Item 1a. Risk
Factors for discussion of the risks associated with drug candidates in development and the risks
and uncertainties associated with clinical development at any stage.
General and administrative (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
General &
administrative |
|
$ |
51,497 |
|
|
$ |
57,282 |
|
|
$ |
82,358 |
|
|
$ |
(5,785 |
) |
|
$ |
(25,076 |
) |
|
|
(10 |
%) |
|
|
(30 |
%) |
General and administrative expenses are associated with administrative staffing, business
development, marketing, and legal.
The decrease in general and administrative expenses during the year ended December 31, 2008
compared to the year ended December 31, 2007 is primarily attributable to decreased professional
fees of $5.1 million and decreased salaries and benefits of $8.8 million, partially offset by
increased marketing costs of $1.7 million related to our co-promotion agreement with Bayer
Healthcare LLC for BAY41-6551, decreased corporate overhead costs allocated out of general and
administrative departments to manufacturing and research and development of $4.0 million, and other
net increases of $2.4 million.
The decrease in general and administrative expenses during the year ended December 31, 2007
compared to the year ended December 31, 2006 is primarily attributable to decreased non-cash
stock-based compensation expense of $11.9 million, decreased intangible asset amortization of $3.1
million, decreased headcount resulting in decreased salaries and benefits of $2.3 million,
decreased professional fees of $5.9 million, and a $1.8 million decrease in connection with the
winding down of our Bradford, UK operations in 2006.
Impairment of long lived assets (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
Impairment of long
lived assets |
|
$ |
1,458 |
|
|
$ |
28,396 |
|
|
$ |
9,410 |
|
|
$ |
(26,938 |
) |
|
$ |
18,986 |
|
|
|
(95 |
%) |
|
|
>100 |
% |
43
During the year ended December 31, 2008, impairment of long lived assets includes an
impairment charge of $1.5 million related to a specialized dryer designed for our PEGylation
manufacturing facility. The dryer was not functioning properly and was not being used in
operations. We determined the carrying value of the manufacturing equipment exceeded the fair
value based on a discounted cash flow model.
During the year ended December 31, 2007, impairment of long lived assets includes an
impairment charge of $28.4 million for Exubera-related assets following the termination of our
collaborative agreements with Pfizer.
During the year ended December 31, 2006, impairment of long lived assets includes a write-off
of $5.5 million of certain intangible assets relating to the operations of our former Ireland
subsidiary, $1.2 million relating to the remaining laboratory and office equipment at our Bradford,
UK site, and $2.8 million relating to an asset being constructed for use in one of our partnered
pulmonary drug development programs.
Gain on sale of pulmonary assets (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
Gain on sale of
pulmonary assets |
|
$ |
(69,572 |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
69,572 |
|
|
$ |
|
|
|
|
n/a |
|
|
|
n/a |
|
On December 31, 2008, we sold certain of our pulmonary assets to Novartis for $115.0 million.
The gain on sale of pulmonary assets includes the purchase price received from Novartis less the
net book value of property and equipment of $37.3 million, an equity investment in Pearl
Therapeutics, Inc. of $2.7 million, transaction costs of $4.6 million, and other costs of $0.9
million.
Gain on termination of collaborative agreements, net (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
Gain on termination
of collaborative
agreements, net |
|
$ |
|
|
|
$ |
(79,178 |
) |
|
$ |
|
|
|
$ |
(79,178 |
) |
|
$ |
79,178 |
|
|
|
n/a |
|
|
|
n/a |
|
On November 9, 2007, we terminated our collaborative development and license agreement with
Pfizer and all other agreements between us and Pfizer related to Exubera and NGI. Pursuant to the
termination agreement, we received a one-time payment of $135.0 million from Pfizer in full
satisfaction and release of all contract obligations. The gain on termination of collaborative
agreements, net, includes the Pfizer termination payment received of $135.0 million less our
contractual aggregate liability to Bespak and Tech Group of $32.4 million and less settlement of
outstanding receivables and payables with Pfizer of $23.5 million.
Litigation settlement
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
Litigation settlement |
|
$ |
|
|
|
$ |
1,583 |
|
|
$ |
17,710 |
|
|
$ |
(1,583 |
) |
|
$ |
(16,127 |
) |
|
|
n/a |
|
|
|
(91 |
)% |
During the year ended December 31, 2007, we recorded a litigation settlement charge of $1.6
million related to three employee-related litigation settlements that were entered into in 2007.
On June 30, 2006, we entered into a litigation settlement related to an intellectual property
dispute with the University of Alabama, Huntsville pursuant to which we paid $11.0 million and
agreed to pay an additional $10.0 million in equal $1.0 million installments over ten years
beginning on July 1, 2007. During the year ended December 31, 2006 we recorded a litigation
settlement charge of $17.7 million which reflects the net present value of the settlement payments
using an 8% annual discount rate.
44
Interest income (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
Interest income |
|
$ |
12,495 |
|
|
$ |
22,201 |
|
|
$ |
23,646 |
|
|
$ |
(9,706 |
) |
|
$ |
(1,445 |
) |
|
|
(44 |
%) |
|
|
(6 |
%) |
The decrease in interest income for the year ended December 31, 2008, compared to the year
ended December 31, 2007, was primarily due to lower interest rates on our cash, cash equivalents,
and available-for-sale investments in 2008 compared to 2007.
The decrease in interest income during the year ended December 31, 2007 compared to the year
ended December 31, 2006 is primarily due to a decline in the average balance of cash, cash
equivalents, and investments in marketable securities due to repayment of $102.7 million in
convertible subordinated notes.
Interest expense (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
Interest expense |
|
$ |
15,192 |
|
|
$ |
18,638 |
|
|
$ |
20,793 |
|
|
$ |
(3,446 |
) |
|
$ |
(2,155 |
) |
|
|
(18 |
%) |
|
|
(10 |
%) |
The decrease in interest expense for the year ended December 31, 2008, compared to the year
ended December 31, 2007, was primarily attributable to a lower average balance of convertible
subordinated notes outstanding in 2008. We repurchased $100.0 million of our 3.25% convertible
subordinated notes during the fourth quarter of 2008. We expect interest expense to decrease in
2009 as a result of this convertible subordinated note repurchase.
The decrease in interest expense during the year ended December 31, 2007 compared to the year
ended December 31, 2006 was primarily due to a lower average balance of convertible subordinated
notes outstanding during 2007. We repaid $36.0 million of our 5% convertible subordinated notes in
February 2007 and we repaid $66.6 million of our 3.5% convertible subordinated notes in October
2007.
Other income, net (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
Other income
(expense), net |
|
$ |
58 |
|
|
$ |
1,133 |
|
|
$ |
2,444 |
|
|
$ |
(1,075 |
) |
|
$ |
(1,311 |
) |
|
|
(95 |
%) |
|
|
(54 |
%) |
During the year ended December 31, 2007, we recognized a $0.9 million gain from the sale of
the management buy-out of our nebulizer device business operated in our wholly-owned Ireland
subsidiary, which was completed on November 30, 2007 in consideration of a payment to us of $2.2
million and a net gain of $0.9 million.
During the year ended December 31, 2006, we recognized a $2.2 million gain from the sale of an
equity investment in Confluent Technologies. We do not expect to realize income from such
transactions in the future.
45
Gain on debt extinguishment (in thousands except percentages)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
Increase/ |
|
|
|
Years ended December 31, |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
(Decrease) |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
|
2008 vs. 2007 |
|
|
2007 vs. 2006 |
|
Gain on debt extinguishment |
|
$ |
50,149 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
50,149 |
|
|
$ |
|
|
|
|
n/a |
|
|
|
n/a |
|
During the three months ended December 31, 2008, we repurchased approximately $100.0 million
in par value of our 3.25% convertible subordinated notes for an aggregate purchase price of $47.8
million. The recognized gain on debt extinguishment is net of transaction costs of $1.0 million
and accelerated amortization of our deferred financing costs of $1.1 million.
Liquidity and Capital Resources
We have financed our operations primarily through revenue from product sales and royalties and
research and development contracts, public and private placements of debt and equity. We do not
utilize off-balance sheet financing arrangements as a source of liquidity or financing.
Additionally, at December 31, 2008, we had letter of credit arrangements with certain financial
institutions and vendors, including our landlord, totaling $2.9 million. These letters of credit
expire during 2009 and are secured by investments in similar amounts.
As of December 31, 2008, we had cash, cash equivalents and investments in marketable
securities of $379.0 million and indebtedness of $242.6 million, including $215.0 million of
convertible subordinated notes, $21.6 million in capital lease obligations and $6.0 million in
other liabilities.
Due to the recent adverse developments in the credit markets, we may experience reduced
liquidity with respect to some of our short-term investments. These investments are generally held
to maturity, which is less than one year. However, if the need arose to liquidate such securities
before maturity, we may experience losses on liquidation. As of December 31, 2008, we held $233.6
million of available-for-sale investments, excluding money market funds, with an average time to
maturity of 72 days. To date we have not experienced any liquidity issues with respect to these
securities, but should such issues arise, we may be required to hold some, or all, of these
securities until maturity. We believe that, even allowing for potential liquidity issues with
respect to these securities, our remaining cash and cash equivalents and short-term investments
will be sufficient to meet our anticipated cash needs for at least the next twelve months. We have
the ability and intent to hold our debt securities to maturity when they will be redeemed at full
par value. Accordingly, we consider unrealized losses to be temporary and have not recorded a
provision for impairment.
Cash flows used in operating activities
During the year ended December 31, 2008, net cash used for our operating activities was $145.8
million. The decrease in net cash provided by our operating activities for the year ended December
31, 2008 as compared to the year ended December 31, 2007, resulted from the $135.0 million cash
payment received from Pfizer in 2007 under the Exubera termination agreement and up-front payments
of $50.0 million and $24.6 million received in 2007 from Bayer Healthcare LLC and Pfizer,
respectively. In addition, the net cash used for our operating activities for the year ended
December 31, 2008 included a number of significant items including a $10.0 million clinical
development milestone received from Bayer Healthcare LLC under our collaboration agreement for
BAY41-6551 (NKTR-061, Amikacin Inhale), payments by us to Bespak Europe Ltd. and Tech Group, Inc.
of $39.9 million for amounts due under termination agreements with these Exubera inhaler device
contract manufacturers, all of which was recorded as an expense in 2007, $6.8 million paid to
maintain Exubera manufacturing capacity through April 2008, and $5.4 million for severance,
employee benefits, and outplacement services in connection with our workforce reduction plans. We
expect our cash flows used in operations to decrease in 2009.
During the year ended December 31, 2007, net cash provided by operating activities was $146.3
million. During the year ended December 31, 2007, net cash provided by operating activities
increased by $239.0 million compared to the year ended December 31, 2006, in which we used $92.7
million in operating activities. The increase in cash provided by operations in the year ended
December 31, 2007 included a number of significant items including a contract termination payment
received from Pfizer of $135.0 million and up-front payments of $50.0 million and $24.6 million
received from Bayer Healthcare LLC and Pfizer, respectively.
46
Cash flows from investing activities
On December 31, 2008, we completed the sale of certain pulmonary assets to Novartis for a
purchase price of $115.0 million. We paid $0.2 million in transaction costs related to the sale
during the year ended December 31, 2008 and expect to pay approximately $4.4 million in transaction
costs in the three months ending March 31, 2009, all of which we expensed in the three months ended
December 31, 2008.
We purchased $18.9 million, $32.8 million, and $22.5 million of property and equipment in the
year ended December 31, 2008, 2007, and 2006, respectively. We expect our capital additions to
remain at a consistent level during the year ended December 31, 2009, as we complete our research
and development facility in Hyderabad, India.
In July 2008, we invested $4.2 million in Pearl Therapeutics Inc. (Pearl). In 2007, we
granted Pearl a limited field intellectual property license to certain of our proprietary pulmonary
delivery technology. Upon the closing of the Novartis asset sale transaction on December 31, 2008,
we transferred our ownership interest in Pearl to Novartis and assigned the intellectual property
license to Novartis.
Cash flows used in financing activities
During the year ended December 31, 2008, we repurchased approximately $100.0 million in par
value of our 3.25% convertible subordinated notes for an aggregate purchase price of $47.8 million.
The $215.0 million of 3.25% convertible subordinated notes outstanding at December 31, 2008, are
due in September 2012.
During the year ended December 31, 2007, we repaid $102.7 million of convertible subordinated
notes.
Contractual Obligations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments due by period |
|
|
|
|
|
|
|
<=1 yr |
|
|
2-3 yrs |
|
|
4-5 yrs |
|
|
|
|
|
|
Total |
|
|
2009 |
|
|
2010-2011 |
|
|
2012-2013 |
|
|
2014+ |
|
Obligations (1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible subordinated notes, including interest |
|
$ |
241,153 |
|
|
$ |
6,986 |
|
|
$ |
13,972 |
|
|
$ |
220,195 |
|
|
$ |
|
|
Capital leases, including interest |
|
|
38,822 |
|
|
|
4,717 |
|
|
|
9,659 |
|
|
|
10,022 |
|
|
|
14,424 |
|
Purchase commitments (2) |
|
|
17,042 |
|
|
|
17,042 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Litigation settlement, including interest |
|
|
8,000 |
|
|
|
1,000 |
|
|
|
2,000 |
|
|
|
2,000 |
|
|
|
3,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
305,017 |
|
|
$ |
29,745 |
|
|
$ |
25,631 |
|
|
$ |
232,217 |
|
|
$ |
17,424 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The above table does not include certain commitments and contingencies which are discussed in
Note 8 of Item 8. Financial Statements and Supplementary Data. |
|
(2) |
|
Substantially all of this amount was subject to open purchase orders as of December 31, 2008
that were issued under existing contracts. This amount does not represent minimum contract
termination liability. |
Given our current cash requirements, we forecast that we will have sufficient cash to meet our
net operating expense requirements and contractual obligations at least through December 31, 2010.
We plan to continue to invest in our growth and our future cash requirements will depend upon the
timing and results of these investments. Our capital needs will depend on many factors, including
continued progress in our research and development programs, progress with preclinical and clinical
trials of our proprietary and partnered drug candidates, our ability to successfully enter into
additional collaboration agreements for one or more of our proprietary drug candidates or
intellectual property that we control, the time and costs involved in obtaining regulatory
approvals, the costs of developing and scaling our clinical and commercial manufacturing
operations, the costs involved in preparing, filing, prosecuting, maintaining and enforcing patent
claims, the need to acquire licenses to new technologies and the status of competitive products.
Included in our purchase commitments above is approximately $2.7 million of capital purchase
commitments.
47
To date we have incurred substantial debt as a result of our issuances of subordinated notes
that are convertible into our common stock. Our substantial debt, the market price of our
securities, and the general economic climate, among other factors, could have material consequences
for our financial condition and could affect our sources of short-term and long-term funding. Our
ability to meet our ongoing operating expenses and repay our outstanding indebtedness is dependent
upon our and our partners ability to successfully complete clinical development of, obtain
regulatory approvals for and successfully commercialize new drugs. Even if we or our partners are
successful, we may require additional capital to continue to fund our operations and repay our debt
obligations as they become due. There can be no assurance that additional funds, if and when
required, will be available to us on favorable terms, if at all.
Off Balance Sheet Arrangements
We do not utilize off-balance sheet financing arrangements as a source of liquidity or
financing.
Critical Accounting Policies
The preparation of financial statements in conformity with U.S. Generally Accepted Accounting
Principles (GAAP) requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date
of the financial statements and the reported amounts of revenues and expenses during the reporting
period.
We base our estimates on historical experience and on various other assumptions that we
believe to be reasonable under the circumstances, the results of which form our basis for making
judgments about the carrying value of assets and liabilities that are not readily apparent from
other sources, and evaluate our estimates on an ongoing basis. Actual results may differ from those
estimates under different assumptions or conditions. We have determined that for the periods
reported in this report, the following accounting policies and estimates are critical in
understanding our financial condition and results of our operations.
Revenue Recognition
Collaboration and other research revenue includes amortization of up-front fees. Up-front fees
should be recognized ratably over the expected benefit period under the arrangement. Given the
uncertainties of research and development collaborations, significant judgment is required to
determine the duration of the arrangement. We have $57.2 million of deferred up-front fees related
to five research and collaboration agreements that are being amortized over an average of 12 years.
We considered shorter and longer amortization periods. The shortest reasonable period is the end of
the development period (estimated to be 4 to 6 years). Given the statistical probability of drug
development success in the bio-pharmaceutical industry, drug development programs have only a
5%-10% probability of reaching commercial success. The longest period is either the contractual
life of the agreement, which is generally 10-12 years from the first commercial sale, or the end of
the patent life, which is frequently 15-17 years. If we had determined a longer or shorter
amortization period was appropriate, our annual up-front fee amortization could be as low as $4.0
million or as high as $14.0 million.
Milestone payments that we receive under our collaboration agreements are deferred and
recorded as revenue ratably over the period of time between the achievement of the milestone and
the estimated date of completion of the next development milestone. Management makes its best
estimate of the period of time until the next milestone is reached. This estimate affects the
recognition of revenue for completion of the previous milestone. The original estimate is
periodically evaluated to determine if circumstances have caused the estimate to change and if so,
amortization of revenue is adjusted prospectively.
Stock-Based Compensation
We use the Black-Scholes option valuation model adjusted for the estimated historical
forfeiture rate for the respective grant to determine the estimated fair value of our stock-based
compensation arrangements on the date of grant (grant date fair value) and expense this value
ratably over the service period of the option or performance period of the Restricted Stock Unit
award (RSU). The Black-Scholes option pricing model requires the input of highly subjective
assumptions. Because our employee stock options have characteristics significantly different from
those of traded options, and because changes in the subjective input assumptions can materially
affect the fair value estimate, in managements opinion, the existing models may not provide a
reliable single measure of the fair value of our employee stock options or common stock purchased
under our employee stock purchase plan. In addition, management continually assesses these assumptions
and methodologies used to calculate the estimated fair value of stock-based compensation.
Circumstances may change and additional data may become available over time, which could result in
changes to the assumptions and methodologies, and which could materially impact our fair value
determination.
48
Further, we have issued performance-based RSU awards totaling approximately 1,010,000 shares
of our common stock to certain employees. These awards vest based upon achieving three
pre-determined performance milestones. We are expensing the grant date fair value of the awards
ratably over the expected performance period for the RSU awards in which the performance milestones
are probable of achievement under a Statement of Financial Accounting Standards No. 5, Accounting
for Contingencies, definition. The total grant date fair value of the RSU awards was $19.8 million,
including $4.0 million for the first milestone, $7.9 million for the second milestone, and $7.9
million for the third milestone.
The first performance milestone was achieved and approximately 174,035 shares were fully
vested and released during the year ended December 31, 2007. The second performance milestone
related to the achievement of $30.0 million of Exubera royalty revenue from Pfizer in one calendar
quarter. During the year ended December 31, 2007, we determined that it is not probable that future
Exubera product sales will be sufficient to meet the second performance milestone and we reversed
$2.8 million of previously recognized expense. The third performance milestone relates to the first
filing (whether by us or a third party licensee or partner of ours) and acceptance of a New Drug
Application (NDA) or Biologics License Application (BLA) by the FDA or an equivalent filing and
acceptance with the European Medicines Agency for a proprietary drug candidate. Based on our
current product pipeline development efforts, we currently estimate that the third performance
milestone is currently probable of achievement by the end of the third quarter of 2011.
Evaluating and estimating the probability of achieving the remaining performance milestone and
the appropriate timing related to the achievement is highly subjective and requires periodic
reassessment of rapidly changing facts and circumstances. Actual achievement of these performance
milestones or changes in facts and circumstances may cause significant fluctuations in expense
recognition between reporting periods and would result in changes in the timing and amount of
expense recognition related to these RSU awards.
Clinical Trial Accruals
We record accruals for the estimated costs of our clinical trials. Most of our clinical trials
are performed by third-party CROs, which are a significant component of our Research and
development expense. We accrue costs associated with the start-up and reporting phases of the
clinical trials ratably over the estimated duration of the start-up and reporting phases. If the
actual timing of these phases varies from the estimate, we will adjust the accrual prospectively.
We accrue costs associated with treatment phase of clinical trials based on the total estimated
cost of the clinical trials and are expensed ratably based on patient enrollment in the trials.
Income Taxes
We account for income taxes under the liability method in accordance with FASB Statement No.
109, Accounting for Income Taxes, and FASB Interpretation No. 48 (FIN 48), Accounting for
Uncertainty in Income TaxesAn Interpretation of FASB Statement No. 109. Under this method,
deferred tax assets and liabilities are determined based on differences between financial reporting
and tax reporting bases of assets and liabilities and are measured using enacted tax rates and laws
that are expected to be in effect when the differences are expected to reverse. Realization of
deferred tax assets is dependent upon future earnings, the timing and amount of which are
uncertain. FIN 48 contains a two-step approach to recognizing and measuring uncertain tax
positions. The first step is to evaluate the tax position by determining if the weight of available
evidence indicates that it is more likely than not that the position will be sustained upon tax
authority examination, including resolution of related appeals or litigation processes, if any. The
second step is to measure the tax benefit as the largest amount that is more than 50% likely of
being realized upon ultimate settlement.
Adoption of FIN 48, which occurred on January 1, 2007, had no impact on our consolidated
financial position, results of operations, cash flows or our effective tax rate. However, revisions
to the estimated net realizable value of the deferred tax asset in the future could cause our
provision for income taxes to vary significantly from period to period.
At December 31, 2008, we had significant federal and state net operating loss and research
credit carry forwards which were offset by a full valuation allowance, due to our inability to
estimate long-term future taxable income with a more likely than not certainty. Upon adoption of
FIN 48, we did not recognize an increase or a decrease in the liability for net unrecognized tax
benefits, which would be accounted for through retained earnings. We historically accrued for
uncertain tax
positions in deferred tax assets as we have been in a net operating loss position since
inception and any adjustments to our tax positions would result in an adjustment of our net
operating loss or tax credit carry forwards rather than resulting in a cash outlay. If we are
eventually able to recognize these uncertain positions, our effective tax rate would be reduced. We
currently have a full valuation allowance against our net deferred tax asset which would impact the
timing of the effective tax rate benefit should any of these uncertain tax positions be favorably
settled in the future.
49
On a periodic basis, we will continue to evaluate the realizability of our deferred tax assets
and liabilities and adjust such amounts in light of changing facts and circumstances, including but
not limited to the level of past and future taxable income, the utilization of the carry forwards,
tax legislation, rulings by relevant tax authorities, tax planning strategies and if applicable,
the progress of ongoing tax audits. The ultimate realization of deferred tax assets is dependent
upon the generation of future taxable income during the period in which those temporary differences
become deductible or the net operating loss and research credit carry forwards can be utilized.
Recent Accounting Pronouncements
FASB Statement of Position No. 157-2
In February 2008, the FASB issued FASB Staff Position 157-2, Effective Date of FASB Statement
No. 157 (FSP 157-2), which delays the effective date of SFAS No. 157 to fiscal years beginning
after November 15, 2008, for all nonfinancial assets and nonfinancial liabilities, except for items
that are recognized or disclosed at fair value in the financial statements on a recurring basis (at
least annually). In accordance with FSP 157-2, the fair value measurements for non-financial
assets and liabilities is required to be adopted effective for fiscal years beginning after
November 15, 2008 We believe the adoption of the delayed items of SFAS No. 157 will not have a
material impact on our financial statements.
EITF 07-1
In December 2007, the FASB ratified EITF Issue No. 07-1, Accounting for Collaborative
Arrangements, which defines collaborative arrangements and establishes reporting and disclosure
requirements for transactions between participants in a collaborative arrangement and between
participants in the arrangements and third parties. This issue is effective retrospectively to all
prior periods presented for all collaborative arrangements existing as of the effective date for
fiscal years beginning after December 15, 2008. We believe the adoption of EITF 07-1 will not
have a material impact on our financial statements.
FSP APB 14-1
In May 2008, the FASB issued FSP Accounting Principles Board (APB) 14-1 Accounting for
Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash
Settlement) (FSP APB 14-1). FSP APB 14-1 addresses instruments commonly referred to as Instrument
C from EITF 90-19, which requires the issuer to settle the principal amount in cash and the
conversion spread in cash or net shares at the issuers option. FSP APB 14-1 requires the issuer
of these instruments account for the liability (debt) and equity (conversion option) components of
the instrument in a manner that reflects the issuers nonconvertible debt borrowing rate. FSP APB
14-1 is effective for fiscal years beginning after December 15, 2008 and interim periods within
those fiscal years on a retroactive basis. Early application is not permitted. The noteholders may
only convert outstanding convertible subordinated notes to shares of our common stock, therefore we
do not expect FSP APB 14-1 to have a material impact on our financial position or results of
operations.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
Interest Rate and Market Risk
The primary objective of our investment activities is to preserve principal while at the same
time maximizing yields without significantly increasing risk. To achieve this objective, we invest
in liquid, high quality debt securities. Our investments in debt securities are subject to interest
rate risk. To minimize the exposure due to an adverse shift in interest rates, we invest in
short-term securities and maintain a weighted average maturity of one year or less.
A hypothetical 50 basis point increase in interest rates would result in an approximate $0.4
million decrease, less than 1%, in the fair value of our available-for-sale securities at December
31, 2008. This potential change is based on sensitivity
analyses performed on our investment securities at December 31, 2008. Actual results may
differ materially. The same hypothetical 50 basis point increase in interest rates would have
resulted in an approximate $0.7 million decrease, less than 1%, in the fair value of our
available-for-sale securities at December 31, 2007.
50
Due to the adverse developments in the credit markets in 2008, we may experience reduced
liquidity with respect to some of our short-term investments. These investments are generally held
to maturity, which is less than one year. However, if the need arose to liquidate such securities
before maturity, we may experience losses on liquidation. As of December 31, 2008, we held $233.6
million of available-for-sale investments, excluding money market funds, with an average time to
maturity of 72 days. To date we have not experienced any liquidity issues with respect to these
securities, but should such issues arise, we may be required to hold some, or all, of these
securities until maturity. We believe that, even allowing for potential liquidity issues with
respect to these securities, our remaining cash and cash equivalents and short-term investments
will be sufficient to meet our anticipated cash needs for at least the next twelve months. We have
the ability and intent to hold our debt securities to maturity when they will be redeemed at full
par value. Accordingly, we consider unrealized losses to be temporary and have not recorded a
provision for impairment.
Foreign Currency Risk
The majority of our revenue, expense, and capital purchasing activities are transacted in U.S.
dollars. However, since a portion of our operations consists of research and development activities
outside the United States, we have entered into transactions in other currencies, primarily the
Indian Rupee, and we therefore are subject to foreign exchange risk.
Our international operations are subject to risks typical of international operations,
including, but not limited to, differing economic conditions, changes in political climate,
differing tax structures, other regulations and restrictions, and foreign exchange rate volatility.
We do not utilize derivative financial instruments to manage our exchange rate risks.
51
Item 8. Financial Statements and Supplementary Data
NEKTAR THERAPEUTICS
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
52
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders, Nektar Therapeutics
We have audited the accompanying consolidated balance sheets of Nektar Therapeutics as of
December 31, 2008 and 2007, and the related consolidated statements of operations, stockholders
equity and cash flows for each of the three years in the period ended December 31, 2008. Our audits
also included the financial statement schedule listed in the Index at Item 15(a)(2). These
financial statements and schedule are the responsibility of the Companys management. Our
responsibility is to express an opinion on these financial statements and schedule based on our
audits.
We conducted our audits in accordance with the standards of the Public Company Accounting
Oversight Board (United States). Those standards require that we plan and perform the audit to
obtain reasonable assurance about whether the financial statements are free of material
misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements. An audit also includes assessing the accounting principles
used and significant estimates made by management, as well as evaluating the overall financial
statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in all material
respects, the consolidated financial position of Nektar Therapeutics at December 31, 2008 and 2007,
and the consolidated results of its operations and its cash flows for each of the three years in
the period ended December 31, 2008, in conformity with U.S. generally accepted accounting
principles. Also, in our opinion, the related financial statement schedule, when considered in
relation to the basic financial statements taken as a whole, presents fairly in all material
respects the information set forth therein.
As discussed in Note 1 to the consolidated financial statements, Nektar Therapeutics changed
its method of accounting for uncertain tax positions as of January 1, 2007.
We also have audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), Nektars internal control over financial reporting as of December
31, 2008, based on criteria established in Internal Control-Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission and
our report dated March 4, 2009
expressed an unqualified opinion thereon.
/s/ ERNST & YOUNG LLP
San Jose, California
March 4, 2009
53
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders, Nektar Therapeutics
We have audited Nektar Therapeutics internal control over financial reporting as of December
31, 2008, based on criteria established in Internal ControlIntegrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission (the COSO criteria). Nektar
Therapeutics management is responsible for maintaining effective internal control over financial
reporting, and for its assessment of the effectiveness of internal control over financial reporting
included in the accompanying Management Report on Internal Control over Financial Reporting. Our
responsibility is to express an opinion on the companys internal control over financial reporting
based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting
Oversight Board (United States). Those standards require that we plan and perform the audit to
obtain reasonable assurance about whether effective internal control over financial reporting was
maintained in all material respects. Our audit included obtaining an understanding of internal
control over financial reporting, assessing the risk that a material weakness exists, testing and
evaluating the design and operating effectiveness of internal control based on the assessed risk,
and performing such other procedures as we considered necessary in the circumstances. We believe
that our audit provides a reasonable basis for our opinion.
A companys internal control over financial reporting is a process designed to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with generally accepted accounting
principles. A companys internal control over financial reporting includes those policies and
procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately
and fairly reflect the transactions and dispositions of the assets of the company; (2) provide
reasonable assurance that transactions are recorded as necessary to permit preparation of financial
statements in accordance with generally accepted accounting principles, and that receipts and
expenditures of the company are being made only in accordance with authorizations of management and
directors of the company; and (3) provide reasonable assurance regarding prevention or timely
detection of unauthorized acquisition, use or disposition of the companys assets that could have a
material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent
or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are
subject to the risk that controls may become inadequate because of changes in conditions, or that
the degree of compliance with the policies or procedures may deteriorate.
In our opinion, Nektar Therapeutics maintained, in all material respects, effective internal
control over financial reporting as of December 31, 2008, based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), the consolidated balance sheets of Nektar Therapeutics as of
December 31, 2008 and 2007, and the related consolidated statements of operations, stockholders
equity and cash flows for each of the three years in the period ended December 31, 2008 of Nektar
Therapeutics and our report dated March 4, 2009 expressed an unqualified opinion thereon.
/s/ ERNST & YOUNG LLP
San Jose, California
March 4, 2009
54
NEKTAR THERAPEUTICS
CONSOLIDATED BALANCE SHEETS
(In thousands, except per share information)
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
155,584 |
|
|
$ |
76,293 |
|
Short-term investments |
|
|
223,410 |
|
|
|
406,060 |
|
Accounts receivable, net of allowance of
$92 and $33 at December 31, 2008 and 2007,
respectively |
|
|
11,161 |
|
|
|
21,637 |
|
Inventory |
|
|
9,319 |
|
|
|
12,187 |
|
Other current assets |
|
|
6,746 |
|
|
|
7,106 |
|
|
|
|
|
|
|
|
Total current assets |
|
$ |
406,220 |
|
|
$ |
523,283 |
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
73,578 |
|
|
|
114,420 |
|
Goodwill |
|
|
76,501 |
|
|
|
78,431 |
|
Other assets |
|
|
4,237 |
|
|
|
8,969 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
560,536 |
|
|
$ |
725,103 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
13,832 |
|
|
$ |
3,589 |
|
Accrued compensation |
|
|
11,570 |
|
|
|
14,680 |
|
Accrued clinical trial expenses |
|
|
17,622 |
|
|
|
2,895 |
|
Accrued expenses to contract manufacturers |
|
|
|
|
|
|
40,444 |
|
Accrued expenses |
|
|
9,923 |
|
|
|
9,551 |
|
Deferred revenue, current portion |
|
|
10,010 |
|
|
|
19,620 |
|
Other current liabilities |
|
|
5,417 |
|
|
|
7,313 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
$ |
68,374 |
|
|
$ |
98,092 |
|
Convertible subordinated notes |
|
|
214,955 |
|
|
|
315,000 |
|
Capital lease obligations |
|
|
20,347 |
|
|
|
21,632 |
|
Deferred revenue |
|
|
55,567 |
|
|
|
61,349 |
|
Deferred gain |
|
|
5,901 |
|
|
|
8,680 |
|
Other long-term liabilities |
|
|
5,238 |
|
|
|
5,911 |
|
|
|
|
|
|
|
|
Total liabilities |
|
$ |
370,382 |
|
|
$ |
510,664 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Stockholders equity: |
|
|
|
|
|
|
|
|
Preferred stock, 10,000 shares authorized
|
|
|
|
|
|
|
|
|
Series A, $0.0001 par value: 3,100 shares
designated; no shares issued or
outstanding at December 31, 2008 and 2007 |
|
|
|
|
|
|
|
|
Common stock, $0.0001 par value; 300,000
authorized; 92,503 shares and 92,301
shares issued and outstanding at December
31, 2008 and 2007, respectively |
|
|
9 |
|
|
|
9 |
|
Capital in excess of par value |
|
|
1,312,796 |
|
|
|
1,302,541 |
|
Accumulated other comprehensive income |
|
|
1,439 |
|
|
|
1,643 |
|
Accumulated deficit |
|
|
(1,124,090 |
) |
|
|
(1,089,754 |
) |
|
|
|
|
|
|
|
Total stockholders equity |
|
|
190,154 |
|
|
|
214,439 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
560,536 |
|
|
$ |
725,103 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
55
NEKTAR THERAPEUTICS
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share information)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
Product sales and royalties |
|
$ |
41,255 |
|
|
$ |
180,755 |
|
|
$ |
153,556 |
|
Collaboration and other |
|
|
48,930 |
|
|
|
92,272 |
|
|
|
64,162 |
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
90,185 |
|
|
$ |
273,027 |
|
|
$ |
217,718 |
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
28,216 |
|
|
|
137,696 |
|
|
|
113,921 |
|
Other cost of revenue |
|
|
6,821 |
|
|
|
9,821 |
|
|
|
4,168 |
|
Research and development |
|
|
154,417 |
|
|
|
153,575 |
|
|
|
149,381 |
|
General and administrative |
|
|
51,497 |
|
|
|
57,282 |
|
|
|
82,358 |
|
Impairment of long lived assets |
|
|
1,458 |
|
|
|
28,396 |
|
|
|
9,410 |
|
Gain on sale of pulmonary assets |
|
|
(69,572 |
) |
|
|
|
|
|
|
|
|
Gain on termination of collaborative agreements, net |
|
|
|
|
|
|
(79,178 |
) |
|
|
|
|
Litigation settlement |
|
|
|
|
|
|
1,583 |
|
|
|
17,710 |
|
|
|
|
|
|
|
|
|
|
|
Total operating costs and expenses |
|
$ |
172,837 |
|
|
$ |
309,175 |
|
|
$ |
376,948 |
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(82,652 |
) |
|
|
(36,148 |
) |
|
|
(159,230 |
) |
|
|
|
|
|
|
|
|
|
|
Non-Operating income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
12,495 |
|
|
|
22,201 |
|
|
|
23,646 |
|
Interest expense |
|
|
(15,192 |
) |
|
|
(18,638 |
) |
|
|
(20,793 |
) |
Other income (expense), net |
|
|
58 |
|
|
|
1,133 |
|
|
|
2,444 |
|
Gain on extinguishment of debt |
|
|
50,149 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total non-operating income |
|
|
47,510 |
|
|
|
4,696 |
|
|
|
5,297 |
|
|
|
|
|
|
|
|
|
|
|
Loss before provision (benefit) for income taxes |
|
$ |
(35,142 |
) |
|
$ |
(31,452 |
) |
|
$ |
(153,933 |
) |
Provision (benefit) for income taxes |
|
|
(806 |
) |
|
|
1,309 |
|
|
|
828 |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(34,336 |
) |
|
$ |
(32,761 |
) |
|
$ |
(154,761 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.37 |
) |
|
$ |
(0.36 |
) |
|
$ |
(1.72 |
) |
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per share |
|
|
92,407 |
|
|
|
91,876 |
|
|
|
89,789 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
56
NEKTAR THERAPEUTICS
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
Preferred Shares |
|
|
Common Shares |
|
|
Capital In |
|
|
|
|
|
|
Other |
|
|
|
|
|
|
Total |
|
|
|
|
|
|
|
Amount |
|
|
|
|
|
Excess of |
|
|
Deferred |
|
|
Comprehensive |
|
|
Accumulated |
|
|
Stockholders |
|
|
|
Shares |
|
|
Paid In |
|
|
Shares |
|
|
Par Value |
|
|
Par Value |
|
|
Compensation |
|
|
Income/(Loss) |
|
|
Deficit |
|
|
Equity |
|
Balance at December 31, 2005 |
|
|
20 |
|
|
|
|
|
|
|
87,707 |
|
|
$ |
9 |
|
|
$ |
1,233,690 |
|
|
$ |
(2,949 |
) |
|
$ |
(1,707 |
) |
|
$ |
(902,232 |
) |
|
$ |
326,811 |
|
Stock option exercises |
|
|
|
|
|
|
|
|
|
|
2,326 |
|
|
|
|
|
|
|
20,642 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,642 |
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29,143 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29,143 |
|
SFAS No. 123R transition adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,949 |
) |
|
|
2,949 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of Preferred Stock |
|
|
(20 |
) |
|
|
|
|
|
|
1,023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercises |
|
|
|
|
|
|
|
|
|
|
12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares issued for employee plans(1) |
|
|
|
|
|
|
|
|
|
|
212 |
|
|
|
|
|
|
|
3,425 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,425 |
|
Stock-based compensation to consultants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31 |
|
Other comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,769 |
|
|
|
|
|
|
|
1,769 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(154,761 |
) |
|
|
(154,761 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(152,992 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006 |
|
|
|
|
|
|
|
|
|
|
91,280 |
|
|
$ |
9 |
|
|
$ |
1,283,982 |
|
|
$ |
|
|
|
$ |
62 |
|
|
$ |
(1,056,993 |
) |
|
$ |
227,060 |
|
Stock option exercises and RSU release |
|
|
|
|
|
|
|
|
|
|
761 |
|
|
|
|
|
|
|
2,915 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,915 |
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,193 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,193 |
|
Shares issued for employee plans(1) |
|
|
|
|
|
|
|
|
|
|
260 |
|
|
|
|
|
|
|
2,451 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,451 |
|
Other comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,581 |
|
|
|
|
|
|
|
1,581 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(32,761 |
) |
|
|
(32,761 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(31,180 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007 |
|
|
|
|
|
|
|
|
|
|
92,301 |
|
|
$ |
9 |
|
|
$ |
1,302,541 |
|
|
$ |
|
|
|
$ |
1,643 |
|
|
$ |
(1,089,754 |
) |
|
$ |
214,439 |
|
Stock option exercises and RSU release |
|
|
|
|
|
|
|
|
|
|
146 |
|
|
|
|
|
|
|
122 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
122 |
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,871 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,871 |
|
Shares issued for employee plans(1) |
|
|
|
|
|
|
|
|
|
|
56 |
|
|
|
|
|
|
|
262 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
262 |
|
Other comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(204 |
) |
|
|
|
|
|
|
(204 |
) |
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(34,336 |
) |
|
|
(34,336 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(34,540 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
|
|
|
|
|
|
|
|
|
92,503 |
|
|
$ |
9 |
|
|
$ |
1,312,796 |
|
|
$ |
|
|
|
$ |
1,439 |
|
|
$ |
(1,124,090 |
) |
|
$ |
190,154 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Employee plans include Employee Stock Purchase Plan (ESPP) and 401K Plan |
The accompanying notes are an integral part of these consolidated financial statements.
57
NEKTAR THERAPEUTICS
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
Cash flows provided by (used in) operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(34,336 |
) |
|
$ |
(32,761 |
) |
|
$ |
(154,761 |
) |
Adjustments to reconcile net loss to net cash provided by (used in)
operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Gain on sale of pulmonary assets |
|
|
(69,572 |
) |
|
|
|
|
|
|
|
|
Gain on extinguishment of debt |
|
|
(50,149 |
) |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
22,489 |
|
|
|
29,028 |
|
|
|
33,509 |
|
Stock-based compensation |
|
|
9,871 |
|
|
|
14,779 |
|
|
|
30,982 |
|
Impairment of long lived assets |
|
|
1,458 |
|
|
|
28,396 |
|
|
|
9,410 |
|
Other non-cash transactions |
|
|
1,251 |
|
|
|
109 |
|
|
|
(3,003 |
) |
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Decrease (increase) in trade accounts receivable |
|
|
10,476 |
|
|
|
24,318 |
|
|
|
(34,654 |
) |
Decrease (increase) in inventories |
|
|
2,868 |
|
|
|
1,503 |
|
|
|
3,971 |
|
Decrease (increase) in other assets |
|
|
1,166 |
|
|
|
7,443 |
|
|
|
1,095 |
|
Increase (decrease) in accounts payable |
|
|
6,181 |
|
|
|
(3,147 |
) |
|
|
(8,926 |
) |
Increase (decrease) in accrued compensation |
|
|
(3,382 |
) |
|
|
986 |
|
|
|
3,581 |
|
Increase (decrease) in accrued clinical trial expenses |
|
|
14,727 |
|
|
|
907 |
|
|
|
1,322 |
|
Increase (decrease) in accrued expenses to contract manufacturers |
|
|
(40,444 |
) |
|
|
40,444 |
|
|
|
|
|
Increase (decrease) in accrued expenses |
|
|
(1,332 |
) |
|
|
(5,200 |
) |
|
|
4,181 |
|
Increase (decrease) in deferred revenue |
|
|
(15,392 |
) |
|
|
40,863 |
|
|
|
16,245 |
|
Increase (decrease) in other liabilities |
|
|
(1,662 |
) |
|
|
(1,366 |
) |
|
|
4,333 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) operating activities |
|
$ |
(145,782 |
) |
|
$ |
146,302 |
|
|
$ |
(92,715 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from sale of pulmonary assets, net of transaction costs |
|
|
114,831 |
|
|
|
|
|
|
|
|
|
Investment in Pearl Therapeutics |
|
|
(4,236 |
) |
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(18,855 |
) |
|
|
(32,796 |
) |
|
|
(22,524 |
) |
Maturities of investments |
|
|
588,168 |
|
|
|
591,202 |
|
|
|
405,622 |
|
Sales of investments |
|
|
70,060 |
|
|
|
2,057 |
|
|
|
2,252 |
|
Purchases of investments |
|
|
(475,316 |
) |
|
|
(593,118 |
) |
|
|
(502,230 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
$ |
274,652 |
|
|
$ |
(32,655 |
) |
|
$ |
(116,880 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock, net of issuance costs |
|
|
384 |
|
|
|
3,780 |
|
|
|
22,259 |
|
Payments of loan and capital lease obligations |
|
|
(2,368 |
) |
|
|
(2,895 |
) |
|
|
(10,488 |
) |
Repayments of convertible subordinated notes |
|
|
(47,757 |
) |
|
|
(102,653 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities |
|
$ |
(49,741 |
) |
|
$ |
(101,768 |
) |
|
$ |
11,771 |
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rates on cash and cash equivalents |
|
|
162 |
|
|
|
654 |
|
|
|
311 |
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
$ |
79,291 |
|
|
$ |
12,533 |
|
|
$ |
(197,513 |
) |
Cash and cash equivalents at beginning of year |
|
|
76,293 |
|
|
|
63,760 |
|
|
|
261,273 |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of year |
|
$ |
155,584 |
|
|
$ |
76,293 |
|
|
$ |
63,760 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flows information: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for interest |
|
$ |
14,706 |
|
|
$ |
17,389 |
|
|
$ |
17,751 |
|
Cash paid for income taxes |
|
$ |
812 |
|
|
$ |
801 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental schedule of non-cash investing and financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Property acquired through capital leases |
|
$ |
|
|
|
$ |
4,445 |
|
|
$ |
|
|
The accompanying notes are an integral part of these consolidated financial statements.
58
NEKTAR THERAPEUTICS
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2008
Note 1Organization and Summary of Significant Accounting Policies
Organization and Basis of Presentation
We are a clinical-stage biopharmaceutical company headquartered in San Carlos, California and
incorporated in Delaware. We are developing a pipeline of drug candidates that utilize our
PEGylation and advanced polymer conjugate technology platforms designed to improve the therapeutic
benefits of drugs.
Principles of Consolidation and Use of Estimates
Our consolidated financial statements include the financial position and results of operations
and cash flows of our wholly-owned subsidiaries: Nektar Therapeutics AL, Corporation, Nektar
Therapeutics (India) Private Limited, Nektar Therapeutics UK, Ltd., and Aerogen Inc. All
intercompany accounts and transactions have been eliminated in consolidation.
Our consolidated financial statements are denominated in U.S. dollars. Accordingly, changes in
exchange rates between the applicable foreign currency and the U.S. dollar will affect the
translation of each foreign subsidiarys financial results into U.S. dollars for purposes of
reporting our consolidated financial results. Translation gains and losses are included in
accumulated other comprehensive loss in the stockholders equity section of the balance sheet. To
date, such cumulative translation adjustments have not been material to our consolidated financial
position. Transaction gains and losses arising from activities in other than applicable functional
currency are calculated using the average exchange rate for the applicable period and reported in
net income as a non-operating item in each period. Aggregate gross foreign currency transaction
gains (losses) recorded in net income for the years ended December 31, 2008, 2007, and 2006 were
not material.
The preparation of financial statements in conformity with U.S. generally accepted accounting
principles (GAAP) requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date
of the financial statements and the reported amounts of revenues and expenses during the reporting
period. Actual results could differ from those estimates. On an ongoing basis, we evaluate our
estimates, including those related to inventories and related impairment of investments and long
lived assets, restructuring and contingencies, stock based compensation, and litigation. We base
our estimates on historical experience and on other assumptions that management believes are
reasonable under the circumstances. These estimates form the basis for making judgments about the
carrying values of assets and liabilities when these values are not readily apparent from other
sources.
Reclassifications
Certain items previously reported in specific financial statement captions have been
reclassified to conform to the current period presentation. Such reclassifications have not
impacted previously reported revenues, operating loss or net loss.
Cash, Cash Equivalents, and Investments and Fair Value of Financial Instruments
We consider all investments in marketable securities with an original maturity of three months
or less to be cash equivalents. Investments are designated as available-for-sale and are carried at
fair value, with unrealized gains and losses reported in stockholders equity as accumulated other
comprehensive income (loss). The disclosed fair value related to our investments is based primarily
on the reported fair values in our period-end brokerage statements. We independently validate these
fair values using available market quotes and other information. Investments with maturities
greater than one year from the balance sheet date, if any, are classified as long-term.
Interest and dividends on securities classified as available-for-sale, as well as amortization
of premiums and accretion of discounts to maturity, are included in interest income. Realized gains
and losses and declines in value of available-for-sale securities judged to be
other-than-temporary, if any, are included in other income (expense). The cost of securities sold
is based on the specific identification method.
59
The carrying value of cash, cash equivalents, and investments approximates fair value and is
based on quoted market prices. On January 1, 2008, we adopted the provisions of Statement of
Financial Accounting Standards No. 157, Fair Value Measurements (SFAS No. 157), for financial
assets and financial liabilities. SFAS No. 157 defines fair value, establishes a framework for
measuring fair value in GAAP, and expands disclosures about fair value measurements. SFAS No. 157
does not require any new fair value measurements, but provides guidance on how to measure fair
value by providing a fair value hierarchy used to classify the source of the information. The
standard describes a fair value hierarchy based on three levels of inputs, of which the first two
are considered observable and the last unobservable, that may be used to measure fair value which
are the following:
Level 1Quoted prices in active markets for identical assets or liabilities that the entity
has the ability to access.
Level 2Inputs other than Level 1 that are observable, either directly or indirectly, such as
quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or
other inputs that are observable or can be corroborated by observable market data for substantially
the full term of the assets or liabilities.
Level 3Unobservable inputs that are supported by little or no market activity and that are
significant to the fair value of the assets or liabilities.
A financial instruments level within the fair value hierarchy is based on the lowest level of
any input that is significant to the fair value measurement.
In accordance with FASB Statement of Position No. 157-2, we have deferred adoption of SFAS No.
157 for non-financial assets and non-financial liabilities, including goodwill and property and
equipment, until January 1, 2009.
Accounts Receivable and Significant Customer Concentrations
Our customers are primarily pharmaceutical and biotechnology companies that are located in the
U.S. and Europe. Our accounts receivable balance contains billed and unbilled trade receivables
from product sales and royalties and collaborative research agreements. We provide for an allowance
for doubtful accounts by reserving for specifically identified doubtful accounts. We generally do
not require collateral from our customers. We perform a regular review of our customers payment
histories and associated credit risk. We have not experienced significant credit losses from our
accounts receivable. At December 31, 2008, three different customers represented 29%, 19%, and 15%,
respectively, of our accounts receivable. At December 31, 2007, three different customers
represented 28%, 24%, and 22%, respectively, of our accounts receivable.
Inventories and Significant Supplier Concentrations
Inventories are computed on a first-in, first-out basis and stated net of reserves at the
lower of cost or market. Inventory costs include direct materials, direct labor, and manufacturing
overhead. Supplies inventory related to research and development activities are expensed when
purchased.
We are dependent on our partners and vendors to provide raw materials, drugs and devices of
appropriate quality and reliability and to meet applicable regulatory requirements. Consequently,
in the event that supplies are delayed or interrupted for any reason, our ability to develop and
produce our products could be impaired, which could have a material adverse effect on our business,
financial condition and results of operation.
Property and Equipment
Property and equipment are stated at cost. Major improvements are capitalized, while
maintenance and repairs are expensed when incurred. Manufacturing, laboratory and other equipment
are depreciated using the straight-line method generally over estimated useful lives of three to
seven years. Leasehold improvements and buildings are depreciated using the straight-line method
over the shorter of the estimated useful life or the remaining term of the lease.
In accordance with SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived
Assets, we periodically review our property and equipment for recoverability whenever events or
changes in circumstances indicate that the carrying value may not be recoverable. Generally, an
impairment loss would be recognized if the carrying amount of an asset exceeds the sum of the
discounted cash flows expected to result from the use and eventual disposal of the asset. Please
refer to Note 13 of Notes to Consolidated Financial Statements for additional information on the
impairment analysis performed.
Goodwill
Goodwill represents the excess of the price paid for another entity over the fair value of the
assets acquired and liabilities assumed in a business combination. We account for our goodwill
asset in accordance with SFAS No. 142, Goodwill and Other Intangible Assets (SFAS No. 142), and
test for impairment in the fourth quarter of each year using an October 1 measurement date, as well
as at other times when impairment indicators exists or when events occur or circumstances change
that would indicate the carrying amount may not be fully recoverable.
60
For purposes of our annual impairment test, we have identified and assigned goodwill to two
reporting units (as defined in SFAS No. 142): (1) pulmonary technology and (2) PEGylation and
advanced polymer conjugate technology. Goodwill is tested for impairment at the reporting unit
level using a two-step approach. The first step is to compare the fair value of a reporting units
net assets, including assigned goodwill, to the book value of its net assets, including assigned
goodwill. If the fair value of the reporting unit is greater than its net book value, the assigned
goodwill is not considered impaired. If the fair value is less than the reporting units net book
value, we perform a second step to measure the amount of the impairment, if any. The second step
would be to compare the book value of the reporting units assigned goodwill to the implied fair
value of the reporting units goodwill. As of December 31, 2008 and 2007, the carrying value of
our goodwill was $76.5 million and $78.4 million, respectively. Approximately $1.9 million of
goodwill allocated to our pulmonary reporting unit was included in the sale of certain pulmonary
assets to Novartis. There were no indications of impairment at December 31, 2008 or December 31,
2007.
Revenue Recognition
We recognize revenue in accordance with Securities and Exchange Commission Staff Accounting
Bulletin No. 104, Revenue Recognition in Financial Statements (SAB 104) and Emerging Issues Task
Force, Issue No. 00-21 (EITF 00-21), Revenue Arrangements with Multiple Deliverables.
Revenue is recognized when there is persuasive evidence that an arrangement exists, delivery
has occurred, the price is fixed and determinable, and collection is reasonably assured. Allowances
are established for estimated sales returns and uncollectible amounts.
Product Sales and Royalty Revenue
Product sales are primarily derived from cost-plus manufacturing and supply agreements with
our collaboration partners, and revenue is recognized in accordance with the terms of the related
collaboration agreement. We have not experienced any significant returns from our customers.
Generally, we are entitled to royalties from our partners based on their net sales once their
products are approved for commercial sale. We recognize royalty revenue when the cash is received
or when the royalty amount to be received is estimable and collection is reasonably assured.
Collaboration and other revenue
Collaborative research and development arrangements
We enter into collaborative research and development arrangements with pharmaceutical and
biotechnology partners that may involve multiple deliverables. Our arrangements may contain the
following elements: upfront fees, collaborative research, milestone payments, manufacturing and
supply, royalties and license fees. The principles and guidance outlined in EITF No. 00-21 provide
a framework to (a) determine whether an arrangement involving multiple deliverables contains more
than one unit of accounting, and (b) determine how the arrangement consideration should be measured
and allocated to the separate units of accounting in the arrangement. Significant judgment is
required when determining the separate units of accounting and the fair value of individual
deliverables. For each separate unit of accounting we have objective and reliable evidence of fair
value using available internal evidence for the undelivered item(s) and our arrangements generally
do not contain a general right of return relative to the delivered item. We use the residual method
to allocate the arrangement consideration when it does not have fair value of a delivered item(s).
Under the residual method, the amount of consideration allocated to the delivered item equals the
total arrangement consideration less the aggregate fair value of the undelivered items.
Contract research revenue from collaborative research and development agreements is recorded
when earned based on the performance requirements of the contract. Advance payments for research
and development revenue received in excess of amounts earned are classified as deferred revenue
until earned. Amounts received under these arrangements are generally non-refundable even if the
research effort is unsuccessful.
Payments received for milestones achieved are deferred and recorded as revenue ratably over
the period of time from the achievement of milestone for which we received payment and our estimate
of the date on which the next milestone will be achieved. Management makes its best estimate of the
period of time until the next milestone is reached. This estimate affects the recognition of
revenue for completion of the previous milestone. The original estimate is periodically evaluated
to determine if circumstances have caused the estimate to change and if so, amortization of revenue
is adjusted prospectively. Final milestone payments are recorded and recognized upon achieving the
respective milestone, provided that collection is reasonably assured.
61
License Fee Revenue
We have granted licenses for certain of our intellectual property assets for use in developing
new molecules. We recognize revenue when delivery has occurred and we have no further performance
obligations. We consider delivery to have occurred when the license is granted on an exclusive
basis and the license is for the duration of the intellectual property life.
Exubera Commercialization Readiness Revenue
Exubera commercialization readiness revenue represents reimbursements from Pfizer, of certain
agreed upon operating costs relating to our Exubera inhalation powder manufacturing facilities and
our device contract manufacturing locations in preparation for commercial production, plus a markup
on such costs. Exubera commercialization readiness costs are start up manufacturing costs we have
incurred in our Exubera Inhalation Powder manufacturing facility and our Exubera Inhaler device
contract manufacturing locations in preparation for commercial production.
Shipping and Handling Costs
We record costs related to shipping and handling of product to customers in cost of goods
sold.
Stock-Based Compensation
Stock-based compensation arrangements covered by SFAS No. 123R, Share-Based Payment (SFAS No.
123R) currently include stock option grants and restricted stock unit (RSU) awards under our equity
incentive plans and purchases of common stock by our employees at a discount to the market price
under our Employee Stock Purchase Plan (ESPP). Under SFAS No. 123R, the value of the portion of the
option or award that is ultimately expected to vest is recognized as expense on a straight line
basis over the requisite service periods in our Consolidated Statements of Operations. Stock-based
compensation expense for purchases under the ESPP are recognized based on the estimated fair value
of the common stock during each offering period and the percentage of the purchase discount.
We use the Black-Scholes option valuation model adjusted for the estimated historical
forfeiture rate for the respective grant to determine the estimated fair value of our stock-based
compensation arrangements on the date of grant (grant date fair value) and expense this value
ratably over the service period of the option or performance period of the RSU award. Expense
amounts are allocated among inventory, cost of goods sold, research and development expenses, and
general and administrative expenses based on the function of the applicable employee. The
Black-Scholes option pricing model requires the input of highly subjective assumptions. Because our
employee stock options have characteristics significantly different from those of traded options,
and because changes in the subjective input assumptions can materially affect the fair value
estimate, in managements opinion, the existing models may not provide a reliable single measure of
the fair value of our employee stock options or common stock purchased under the ESPP. In addition,
management will continue to assess the assumptions and methodologies used to calculate estimated
fair value of stock-based compensation. Circumstances may change and additional data may become
available over time, which could result in changes to these assumptions and methodologies, and
which could materially impact our fair value determination.
Research and Development Expense
Research and development costs are expensed as incurred and include salaries, benefits and
other operating costs such as outside services, supplies and allocated overhead costs. We perform
research and development for our proprietary drug candidates and technology development and for
certain third parties under collaboration agreements. For our proprietary drug candidates and our
internal technology development programs, we invest our own funds without reimbursement from a
third party. Costs associated with treatment phase of clinical trials are accrued based on the
total estimated cost of the clinical trials and are expensed ratably based on patient enrollment in
the trials. Costs associated with the start-up and reporting phases of the clinical trials are
expensed ratably over the duration of the reporting and start-up phases.
Our collaboration agreements typically include a license to our intellectual property,
technology and clinical development support, and in certain cases, the manufacture and supply of
our proprietary drug components. Under these collaboration agreements, we may receive up-front
license fees, development cost reimbursement, clinical development and regulatory milestone
payments, fees for manufacturing our proprietary drug components, and royalties on sales if the
drug candidate receives regulatory approval. Many of our collaboration agreements are cancelable
by the partner without significant financial penalty.
62
On January 1, 2008, we adopted EITF No. 07-3, Accounting for Nonrefundable Advance Payments
for Goods or Services for Use in Future Research and Development Activities, which provides
guidance on the accounting for certain nonrefundable advance payments for goods or services that
will be used or rendered for future research and development activities. The adoption did not have
a material impact on our financial position or results of operations.
Net Loss Per Share
Basic net loss per share is calculated based on the weighted-average number of common shares
outstanding during the periods presented. For all periods presented in the Consolidated Statements
of Operations, the net loss available to common stockholders is equal to the reported net loss.
Basic and diluted net loss per share are the same due to our historical net losses and the
requirement to exclude potentially dilutive securities which would have an anti-dilutive effect on
net loss per share. The weighted average of these potentially dilutive securities has been excluded
from the diluted net loss per share calculation and is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
Convertible subordinated notes |
|
|
13,804 |
|
|
|
15,781 |
|
|
|
16,896 |
|
Stock options |
|
|
14,147 |
|
|
|
11,108 |
|
|
|
8,901 |
|
Warrants |
|
|
|
|
|
|
|
|
|
|
13 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
27,951 |
|
|
|
26,889 |
|
|
|
25,810 |
|
|
|
|
|
|
|
|
|
|
|
Income Taxes
We account for income taxes under the liability method in accordance with SFAS No. 109,
Accounting for Income Taxes (SFAS No. 109), and FASB Interpretation No. 48 (FIN 48), Accounting for
Uncertainty in Income TaxesAn Interpretation of FASB Statement No. 109. Under this method,
deferred tax assets and liabilities are determined based on differences between financial reporting
and tax reporting bases of assets and liabilities and are measured using enacted tax rates and laws
that are expected to be in effect when the differences are expected to reverse. Realization of
deferred tax assets is dependent upon future earnings, the timing and amount of which are
uncertain.
FIN 48 contains a two-step approach to recognizing and measuring uncertain tax positions. The
first step is to evaluate the tax position for recognition by determining if the weight of
available evidence indicates that it is more likely than not that the position will be sustained
upon tax authority examination, including resolution of related appeals or litigation processes, if
any. The second step is to measure the tax benefit as the largest amount that is more than 50%
likely of being realized upon ultimate settlement.
We adopted FIN 48 on January 1, 2007. Upon adoption, we did not recognize an increase or a
decrease in the liability for net unrecognized tax benefits, which would be accounted for through
retained earnings.
We have incurred net operating losses since inception and we do not have any significant
unrecognized tax benefits. Our policy is to include interest and penalties related to unrecognized
tax benefits, if any, within the provision for taxes in the consolidated statements of operations.
If we are eventually able to recognize our uncertain positions, our effective tax rate would be
reduced. We currently have a full valuation allowance against our net deferred tax asset which
would impact the timing of the effective tax rate benefit should any of these uncertain tax
positions be favorably settled in the future. Any adjustments to our uncertain tax positions would
result in an adjustment of our net operating loss or tax credit carry forwards rather than
resulting in a cash outlay.
We file income tax returns in the U.S., California and other states, and various foreign
jurisdictions. We are currently not the subject of any income tax examinations. In general, the
earliest open year subject to examination is 2004, although depending upon jurisdiction, tax years
may remain open, subject to certain limitations.
Recent Accounting Pronouncements
FASB Statement of Position No. 157-2
In February 2008, the FASB issued FASB Staff Position 157-2, Effective Date of FASB Statement
No. 157 (FSP 157-2), which delays the effective date of SFAS No. 157 to fiscal years beginning
after November 15, 2008, for all nonfinancial assets and nonfinancial liabilities, except for items
that are recognized or disclosed at fair value in the financial statements on a recurring basis (at
least annually). In accordance with FSP 157-2, the fair value measurements for non-financial
assets and liabilities is required to be adopted effective for fiscal years beginning after
November 15, 2008 We believe the adoption of the delayed items of SFAS No. 157 will not have a
material impact on our financial statements.
63
EITF 07-1
In December 2007, the FASB ratified EITF Issue No. 07-1, Accounting for Collaborative
Arrangements, which defines collaborative arrangements and establishes reporting and disclosure
requirements for transactions between participants in a collaborative arrangement and between
participants in the arrangements and third parties. This issue is effective retrospectively to all
prior periods presented for all collaborative arrangements existing as of the effective date for
fiscal years beginning after December 15, 2008. We believe the adoption of EITF 07-1 will not
have a material impact on our financial statements.
FSP APB 14-1
In May 2008, the FASB issued FSP Accounting Principles Board 14-1 Accounting for Convertible
Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement)
(FSP APB 14-1). FSP APB 14-1 addresses instruments commonly referred to as Instrument C from EITF
90-19, which requires the issuer to settle the principal amount in cash and the conversion spread
in cash or net shares at the issuers option. FSP APB 14-1 requires the issuer of these
instruments account for the liability (debt) and equity (conversion option) components of the
instrument in a manner that reflects the issuers nonconvertible debt borrowing rate. FSP APB 14-1
is effective for fiscal years beginning after December 15, 2008 and interim periods within those
fiscal years on a retroactive basis. Early application is not permitted. The noteholders may
convert outstanding convertible subordinated notes to shares of our common stock only, therefore we
do not expect FSP APB 14-1 to have a material impact on our financial position or results of
operations.
Note 2Cash, Cash Equivalents, and Available-For-Sale Investments
Cash, cash equivalents, and available-for-sale investments are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Estimated Fair Value at |
|
|
|
December 31, 2008 |
|
|
December 31, 2007 |
|
Cash and cash equivalents |
|
$ |
155,584 |
|
|
$ |
76,293 |
|
Short-term investments (less than one year to maturity) |
|
|
223,410 |
|
|
|
406,060 |
|
|
|
|
|
|
|
|
Total cash, cash equivalents, and available-for-sale investments |
|
$ |
378,994 |
|
|
$ |
482,353 |
|
|
|
|
|
|
|
|
Our portfolio of cash, cash equivalents, and available-for-sale investments includes (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
Estimated Fair Value at |
|
|
|
December 31, 2008 |
|
|
December 31, 2007 |
|
U.S. corporate commercial paper |
|
$ |
115,658 |
|
|
$ |
293,866 |
|
Obligations of U.S. corporations |
|
|
26,275 |
|
|
|
100,727 |
|
Obligations of U.S. government agencies |
|
|
91,667 |
|
|
|
37,333 |
|
Cash and money market funds |
|
|
145,394 |
|
|
|
50,427 |
|
|
|
|
|
|
|
|
Total cash, cash equivalents, and available-for-sale investments |
|
$ |
378,994 |
|
|
$ |
482,353 |
|
|
|
|
|
|
|
|
The primary objective of our investment activities is to preserve principal while at the same
time maximizing yields without significantly increasing risk. To achieve this objective, we invest
in liquid, high quality debt securities. Our investments in debt securities are subject to interest
rate risk. To minimize the exposure due to an adverse shift in interest rates, we invest in
short-term securities and maintain a weighted average maturity of one year or less. At December
31, 2008, the average portfolio duration was approximately two months and the contractual maturity
of any single investment did not exceed twelve months. At December 31, 2007, the average portfolio
duration was approximately four months and the contractual maturity of any single investment did
not exceed twelve months
Gross unrealized gains and losses were insignificant at December 31, 2008 and at December 31,
2007. The gross unrealized losses were primarily due to changes in interest rates on fixed income
securities. We have a history of holding our investments to maturity and we have the ability and
intent to hold our debt securities to maturity when they will be redeemed at full par value.
Accordingly, we consider these unrealized losses to be temporary and have not recorded a provision
for impairment.
During the year ended December 31, 2008, we sold available-for-sale securities to fund our
convertible subordinated note repurchase. We received proceeds from these sales totaling $70.1
million and realized a gain of $0.1 million in the income statement for the year period ended
December 31, 2008.
64
At December 31, 2008 and 2007, we had letter of credit arrangements with certain financial
institutions and vendors, including our landlord, totaling $2.9 million and $2.8 million,
respectively. These letters of credit are secured by investments of similar amounts.
The following table represents the fair value hierarchy for our financial assets measured at
fair value on a recurring basis as of December 31, 2008 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
Money market funds |
|
$ |
134,686 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
134,686 |
|
U.S. corporate commercial paper |
|
|
|
|
|
|
115,658 |
|
|
|
|
|
|
|
115,658 |
|
Obligations of U.S. corporations |
|
|
|
|
|
|
26,275 |
|
|
|
|
|
|
|
26,275 |
|
Obligations of U.S. government agencies |
|
|
|
|
|
|
91,667 |
|
|
|
|
|
|
|
91,667 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents and available-for-sale investments |
|
$ |
134,686 |
|
|
$ |
233,600 |
|
|
$ |
|
|
|
$ |
368,286 |
|
Cash |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,708 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, Cash equivalents, and available-for-sale investments |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
378,994 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 1Quoted prices in active markets for identical assets or liabilities.
Level 2Inputs other than Level 1 that are observable, either directly or indirectly, such as
quoted prices for similar assets or liabilities; quoted prices in markets that are not active;
or other inputs that are observable or can be corroborated by observable market data for
substantially the full term of the assets or liabilities.
Level 3Unobservable inputs that are supported by little or no market activity and that are
significant to the fair value of the assets or liabilities.
Note 3Inventory
Inventory consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Raw materials |
|
$ |
6,964 |
|
|
$ |
9,522 |
|
Work-in-process |
|
|
1,743 |
|
|
|
1,749 |
|
Finished goods |
|
|
612 |
|
|
|
916 |
|
|
|
|
|
|
|
|
Total |
|
$ |
9,319 |
|
|
$ |
12,187 |
|
|
|
|
|
|
|
|
Inventory consists of raw materials, work-in-process, and finished goods for our commercial
PEGylation business.
Reserves are determined using specific identification plus an estimated reserve for potential
defective or excess inventory based on historical experience or projected usage. Inventories are
reflected net of reserves of $5.0 million and $5.8 million as of December 31, 2008 and 2007,
respectively.
Note 4Property and Equipment
Property and equipment consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Building and leasehold improvements |
|
$ |
62,260 |
|
|
$ |
114,210 |
|
Laboratory equipment |
|
|
24,549 |
|
|
|
48,425 |
|
Manufacturing equipment |
|
|
8,682 |
|
|
|
18,493 |
|
Furniture, fixtures and other equipment |
|
|
14,717 |
|
|
|
21,169 |
|
Construction-in-progress |
|
|
6,875 |
|
|
|
18,374 |
|
|
|
|
|
|
|
|
Property and equipment at cost |
|
$ |
117,083 |
|
|
$ |
220,671 |
|
|
|
|
|
|
|
|
Less: accumulated depreciation |
|
|
( 43,505 |
) |
|
|
(106,251 |
) |
|
|
|
|
|
|
|
Property and equipment, net |
|
$ |
73,578 |
|
|
$ |
114,420 |
|
|
|
|
|
|
|
|
Building and leasehold improvements include our commercial manufacturing, clinical
manufacturing, research and development and administrative facilities and the related improvements
to these facilities. Laboratory and manufacturing equipment includes assets that support both our
manufacturing and research and development efforts. Construction-in-progress includes assets being
built to enhance our manufacturing and research and development programs. Property and equipment
includes assets acquired through capital leases, please refer to Note 6 of Notes to Consolidated
Financial Statements for additional information on assets acquired through capital leases. During
the year ended December 31, 2008, we capitalized $1.9 million of purchased software costs, which
are included in furniture, fixtures and other equipment.
65
Depreciation expense, including depreciation of assets acquired through capital leases, for
the years ended December 31, 2008, 2007, and 2006 was $19.8 million, $25.9 million, and $26.8
million, respectively.
On December 31, 2008, we sold certain assets and obligations related to our pulmonary
technology, development and manufacturing operations to Novartis Pharmaceuticals Corporation and
Novartis Pharma AG (together referred to as Novartis), including property and equipment with a
gross book value of $108.0 million, accumulated depreciation of $70.7 million, and a net book value
of $37.3 million. Please refer to Note 11 of Notes to Consolidated Financial Statements for
additional information related to the sale of certain pulmonary assets to Novartis.
In accordance with SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived
Assets, we periodically review our Property and Equipment for recoverability whenever events or
changes in circumstances indicate that the carrying value may not be recoverable. During the years
ended December 31, 2008, 2007, and 2006, we recorded impairment charges on our Property and
Equipment of $1.5 million for a specialized dryer in our PEGylation commercial manufacturing
facility, $28.4 million for Exubera-related property and equipment, and $2.8 million for our
property and equipment at Bradford, UK due to shut down of its operations, respectively. Please
refer to Note 13 of Notes to Consolidated Financial Statements for additional information related
to Impairment of Long-Lived Assets.
Note 5Convertible Subordinated Notes
The outstanding balance of our convertible subordinated notes is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Semi-Annual |
|
|
December 31, |
|
|
|
Interest Payment Dates |
|
|
2008 |
|
|
2007 |
|
3.25% Notes due September 2012 |
|
March 28, September 28 |
|
$ |
214,955 |
|
|
$ |
315,000 |
|
Our convertible subordinated notes are unsecured and subordinated in right of payment to any
future senior debt. Costs related to the issuance of these convertible notes are recorded in other
assets in our Consolidated Balance Sheets and are generally amortized to interest expense on a
straight-line basis over the contractual life of the notes. The unamortized deferred financing
costs were $2.2 million and $5.1 million as of December 31, 2008 and 2007, respectively.
Gain on Extinguishment of Debt
During the fourth quarter of 2008, we repurchased $100.0 million of our 3.25% notes for $47.8
million. The recognized gain on debt extinguishment of $50.1 million is net of transaction costs
of $1.0 million and accelerated amortization of deferred financing costs of $1.1 million.
Conversion and Redemption
The notes are convertible at the option of the holder at any time on or prior to maturity into
shares of our common stock. The 3.25% Notes have a conversion rate of 46.4727 shares per $1,000
principal amount, which is equal to a conversion price of approximately $21.52. Additionally, at
any time prior to maturity, if a fundamental change as defined in the 3.25% subordinated debt
indenture occurs, we may be required to pay a make-whole premium on notes converted in connection
therewith by increasing the conversion rate applicable to the notes.
We may redeem the 3.25% Notes in whole or in part for cash at a redemption price equal to 100%
of the principal amount of the Notes plus any accrued but unpaid interest if the closing price of
the common stock has exceeded 150% of the conversion price for at least 20 days in any consecutive
30 day trading period.
66
Note 6Capital Leases
We lease office space and office equipment under capital lease arrangements. The gross
carrying value by major asset class and accumulated depreciation included in Property and equipment
as of December 31, 2008 and 2007 are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Building and leasehold improvements |
|
$ |
23,962 |
|
|
$ |
23,962 |
|
Furniture, fixtures and other equipment |
|
|
261 |
|
|
|
591 |
|
Construction in progress |
|
|
|
|
|
|
1,602 |
|
|
|
|
|
|
|
|
Total assets recorded under capital leases |
|
$ |
24,223 |
|
|
$ |
26,155 |
|
Less: accumulated depreciation |
|
|
(8,050 |
) |
|
|
(6,124 |
) |
|
|
|
|
|
|
|
Net assets recorded under capital leases |
|
$ |
16,173 |
|
|
$ |
20,031 |
|
|
|
|
|
|
|
|
Building Lease
We lease office space at 201 Industrial Road in San Carlos, California under capital lease
arrangements. During the year ended December 31, 2007, we modified our existing lease agreement to
increase our office space by 20,123 square feet of additional premises. We re-evaluated the lease
as amended and continue to classify it as a capital lease.
Under the terms of the lease, the rent will escalate 2% in October of each year for the
original leased premises and the rent will escalate 3% in November of each year for the additional
leased premises. The lease termination date for the original and additional premises is October 5,
2016.
Office Equipment
In November 2007, we entered into a twelve-month lease with Cisco Systems Capital Corporation
related to communication equipment. In October 2008, the lease term ended and we purchased the
equipment for $1.
Future Minimum Lease Payments
Future minimum payments for our capital leases at December 31, 2008 are as follows (in
thousands):
|
|
|
|
|
Years ending December 31, |
|
|
|
|
2009 |
|
$ |
4,717 |
|
2010 |
|
|
4,752 |
|
2011 |
|
|
4,907 |
|
2012 |
|
|
4,958 |
|
2013 |
|
|
5,064 |
|
2014 and thereafter |
|
|
14,424 |
|
|
|
|
|
Total minimum payments required |
|
$ |
38,822 |
|
Less: amount representing interest |
|
|
(17,190 |
) |
|
|
|
|
Present value of future payments |
|
$ |
21,632 |
|
Less: current portion |
|
|
(1,285 |
) |
|
|
|
|
Non-current portion |
|
$ |
20,347 |
|
|
|
|
|
Note 7Litigation Settlement
On June 30, 2006, we, our subsidiary Nektar AL, and a former officer, Milton Harris, entered
into a settlement agreement and general release with the University of Alabama, Huntsville (UAH)
related to an intellectual property dispute. Under the terms of the settlement agreement, we,
Nektar AL, Mr. Harris and UAH agreed to full and complete satisfaction of
all claims asserted in the litigation in exchange for $25.0 million in cash payments. We and
Mr. Harris made an initial payment of $15.0 million on June 30, 2006, of which we paid $11.0
million and Mr. Harris paid $4.0 million. During the year ended December 31, 2006, we recorded a
litigation settlement charge of $17.7 million, which reflects the net present value of the
settlement payments using an 8% annual discount rate. In June 2007 and 2008, respectively, we paid
our annual $1.0 million installment payments. As of December 31, 2008, our accrued liability
related to the UAH settlement was $6.0 million, which is the net present value of our eight annual
$1.0 million payments remaining.
67
Note 8Commitments and Contingencies
Unconditional Purchase Obligations
As of December 31, 2008, we had approximately $17.0 million of unconditional purchase
obligations for purchases of goods and services in 2009 that have not been recognized on our
consolidated balance sheet. These obligations include approximately $6.5 million for research and
development activities pertaining to our ongoing proprietary development of NKTR-102, NKTR-105,
and NKTR-118, $3.4 million for early research activities pertaining to PEGylation and advanced
polymer conjugate drug candidates, $2.7 million for capital projects to enhance our manufacturing
capabilities, research and development programs, and facilities, $1.4 million for inventory
purchases related to PEGylation and advanced polymer conjugate programs, and $2.0 million for
partnered contract research programs.
Royalty Expense
We have certain royalty commitments associated with the shipment and licensing of certain
products. Royalty expense, which is reflected in cost of goods sold in our Consolidated Statements
of Operations, was approximately $4.8 million, $3.9 million, and $5.5 million for the years ended
December 31, 2008, 2007, and 2006, respectively. The overall maximum amount of the obligations is
based upon sales of the applicable product and cannot be reasonably estimated.
Operating Leases
For the years ended December 31, 2008, 2007, and 2006, rent expense for operating leases was
approximately $3.5 million, $4.3 million, and $4.1 million.
We were a party of an operating lease for our San Carlos manufacturing facility through 2012.
On December 31, 2008, this operating lease was assigned to Novartis Pharmaceuticals Inc as part of
the pulmonary asset sale. We have no further liabilities related to this lease.
Legal Matters
From time to time, we may be involved in lawsuits, claims, investigations and proceedings,
consisting of intellectual property, commercial, employment and other matters, which arise in the
ordinary course of business. In accordance with the SFAS No. 5, Accounting for Contingencies, we
make a provision for a liability when it is both probable that a liability has been incurred and
the amount of the loss can be reasonably estimated. These provisions are reviewed at least
quarterly and adjusted to reflect the impact of negotiations, settlements, ruling, advice of legal
counsel, and other information and events pertaining to a particular case. Litigation is inherently
unpredictable. If any unfavorable ruling were to occur in any specific period, there exists the
possibility of a material adverse impact on the results of operations of that period or on our cash
flows and liquidity.
Indemnifications in Connection with Commercial Agreements
As part of our collaboration agreement with our partners related to the license, development,
manufacture and supply of drugs based on our proprietary technologies, we generally agree to
defend, indemnify and hold harmless our partners from and against third party liabilities arising
out of the agreement, including product liability (with respect to our activities) and infringement
of intellectual property to the extent the intellectual property is developed by us and licensed to
our partners. The term of these indemnification obligations is generally perpetual any time after
execution of the agreement. There is generally no limitation on the potential amount of future
payments we could be required to make under these indemnification obligations.
As part of our pulmonary asset sale to Novartis that closed on December 31, 2008, we and
Novartis made representations and warranties and entered into certain covenants and ancillary
agreements which are supported by an indemnity obligation. In the event it were determined that we
breached any of the representations and warranties or covenants and agreements made by us in the
transaction documents, we could incur an indemnification liability depending on the timing, nature,
and amount of any such claims.
68
To date we have not incurred costs to defend lawsuits or settle claims related to these
indemnification obligations. If any of our indemnification obligations is triggered, we may incur
substantial liabilities. Because the obligated amount under these agreements is not explicitly
stated, the overall maximum amount of the obligations cannot be reasonably estimated. No
liabilities have been recorded for these obligations on our Consolidated Balance Sheets as of
December 31, 2008 or 2007.
Indemnification of Underwriters and Initial purchasers of our Securities
In connection with our sale of equity and convertible debt securities, we have agreed to
defend, indemnify and hold harmless our underwriters or initial purchasers, as applicable, as well
as certain related parties from and against certain liabilities, including liabilities under the
Securities Act of 1933, as amended. The term of these indemnification obligations is generally
perpetual. There is no limitation on the potential amount of future payments we could be required
to make under these indemnification obligations. We have never incurred costs to defend lawsuits or
settle claims related to these indemnification obligations. If any of our indemnification
obligations are triggered, however, we may incur substantial liabilities. Because the obligated
amount of this agreement is not explicitly stated, the overall maximum amount of the obligations
cannot be reasonably estimated. Historically, we have not been obligated to make significant
payments for these obligations, and no liabilities have been recorded for these obligations in our
Consolidated Balance Sheets as of December 31, 2008 or 2007.
Director and Officer Indemnifications
As permitted under Delaware law, and as set forth in our Certificate of Incorporation and our
Bylaws, we indemnify our directors, executive officers, other officers, employees, and other agents
for certain events or occurrences that arose while in such capacity. The maximum potential amount
of future payments we could be required to make under this indemnification is unlimited; however,
we have insurance policies that may limit our exposure and may enable us to recover a portion of
any future amounts paid. Assuming the applicability of coverage, the willingness of the insurer to
assume coverage, and subject to certain retention, loss limits and other policy provisions, we
believe any obligations under this indemnification are not material, other than an initial $500,000
per incident for securities related claims and $250,000 per incident for non-securities related
claims retention deductible per our insurance policy. However, no assurances can be given that the
covering insurers will not attempt to dispute the validity, applicability, or amount of coverage
without expensive litigation against these insurers, in which case we may incur substantial
liabilities as a result of these indemnification obligations. Because the obligated amount of this
agreement is not explicitly stated, the overall maximum amount of the obligations cannot be
reasonably estimated. Historically, we have not been obligated to make significant payments for
these obligations, and no liabilities have been recorded for these obligations in our Consolidated
Balance Sheets as of December 31, 2008 or 2007.
Note 9Stockholders Equity
Preferred Stock
We have authorized 10,000,000 shares of Preferred Stock, each share having a par value of
$0.0001. Of these shares, 3,100,000 shares are designated Series A Junior Participating Preferred
Stock (Series A Preferred Stock). The remaining shares are undesignated. We have no preferred
shares issued and outstanding as of December 31, 2008 or 2007.
Series A Preferred Stock
On June 1, 2001, the Board of Directors approved the adoption of a Share Purchase Rights Plan.
Terms of the Rights Plan provide for a dividend distribution of one preferred share purchase right
for each outstanding share of our Common Stock. The Rights have certain anti-takeover effects and
will cause substantial dilution to a person or group that attempts to acquire us on terms not
approved by our Board of Directors. The dividend distribution was payable on June 22, 2001, to the
stockholders of record on that date. Each Right entitles the registered holder to purchase from us
one one-hundredth of a share of Series A Preferred Stock at a price of $225.00 per one
one-hundredth of a share of Series A Preferred Stock, subject
to adjustment. Each one one-hundredth of a share of Series A Preferred Stock has designations
and powers, preferences and rights, and the qualifications, limitations and restrictions which make
its value approximately equal to the value of a share of Common Share.
The Rights are not exercisable until the Distribution Date (as defined in the Certificate of
Designation for the Series A Preferred Stock). The Rights will expire on June 1, 2011, unless the
Rights are earlier redeemed or exchanged by us. Each share of Series A Preferred Stock will be
entitled to a minimum preferential quarterly dividend payment of $1.00, or if greater than $1.00,
will be entitled to an aggregate dividend of 100 times the dividend declared per share of Common
Stock. In the event of liquidation, the holders of the Series A Preferred Stock would be entitled
to $100 per share or, if greater than $100, an aggregate payment equal to 100 times the payment
made per share of Common Stock. Each share of Series A Preferred Stock will have 100 votes, voting
together with the Common Stock. Finally, in the event of any merger, consolidation or other
transaction in which our Common Stock is exchanged, each share of Series A Preferred Stock will be
entitled to receive 100 times the amount of consideration received per share of Common Stock.
Because of the nature of the Series A Preferred Stock dividend and liquidation rights, the value of
one one-hundredth of a share of Series A Preferred Stock should approximate the value of one share
of Common Stock. The Series A Preferred Stock would rank junior to any other future series of
preferred stock. Until a Right is exercised, the holder thereof, as such, will have no rights as a
stockholder, including, without limitation, the right to vote or to receive dividends.
69
Reserved Shares
At December 31, 2008, we have reserved shares of common stock for issuance as follows (in
thousands):
|
|
|
|
|
|
|
As of December 31, 2008 |
|
Convertible subordinated notes |
|
|
9,989 |
|
Option Plans |
|
|
28,922 |
|
ESPP |
|
|
161 |
|
401(k) retirement plans |
|
|
220 |
|
|
|
|
|
Total |
|
|
39,292 |
|
|
|
|
|
Stock Option Plans
The following table summarizes information with respect to shares of our common stock that may
be issued under our existing equity compensation plans as of December 31, 2008 (share number in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of securities remaining |
|
|
|
|
|
|
|
|
|
|
|
available for issuance under |
|
|
|
Number of securities to be |
|
|
Weighted-average |
|
|
equity compensation plans |
|
|
|
issued upon exercise of |
|
|
exercise price of |
|
|
(excluding securities reflected |
|
|
|
outstanding options |
|
|
outstanding options |
|
|
in column(a)) |
|
Plan Category |
|
(a) (1) |
|
|
(b) |
|
|
(c) |
|
Equity compensation
plans approved by
security holders
(2) |
|
|
7,833 |
|
|
$ |
12.53 |
|
|
|
12,443 |
|
Equity compensation
plans not approved
by security holders |
|
|
5,948 |
|
|
$ |
11.66 |
|
|
|
2,827 |
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
13,781 |
|
|
$ |
12.16 |
|
|
|
15,270 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Does not include options 31,738 shares we assumed in connection with the acquisition of
Shearwater Corporation (with a weighted-average exercise price of $0.03 per share). |
|
(2) |
|
Includes shares of common stock available for future issuance under our ESPP as of December
31, 2008. |
2008 Equity Incentive Plan
Our 2008 Equity Incentive Plan (2008 Plan) was adopted by the Board of Directors on March 20,
2008 and was approved by our stockholders on June 6, 2008. The purpose of the 2008 Equity Incentive
Plan is to attract and retain qualified personnel, to provide additional incentives to our
employees, officers, consultants and employee directors and to promote the
success of our business. Pursuant to the 2008 Plan, we may grant or issue incentive stock
options to employees and officers and non-qualified stock options, rights to acquire restricted
stock, restricted stock units, and stock bonuses to consultants, employees, officers and
non-employee directors.
The maximum number of shares of our common stock that may be issued or transferred pursuant to
awards under the 2008 Plan is 9,000,000 shares. Shares issued in respect of any stock bonus or
restricted stock award granted under the 2008 Plan will be counted against the plans share limit
as 1.5 shares for every one share actually issued in connection with the award. The 2008 Plan will
terminate on March 20, 2018, unless earlier terminated by the Board.
The maximum term of a stock option under the 2008 Equity Incentive Plan is eight years, but if
the optionee at the time of grant has voting power of more than 10% of our outstanding capital
stock, the maximum term of an incentive stock option is five years. The exercise price of stock
options granted under the 2008 Plan must be at least equal to 100% (or 110% with respect to holders
of more than 10% of the voting power of our outstanding capital stock) of the fair market value of
the stock subject to the option as determined by the closing price of our common stock on the
Nasdaq Global Market on the date of grant.
70
To the extent that shares are delivered pursuant to the exercise of a stock option, the number
of underlying shares as to which the exercise related shall be counted against the applicable share
limits of the 2008 Plan, as opposed to only counting the shares actually issued. Shares that are
subject to or underlie awards which expire or for any reason are cancelled or terminated, are
forfeited, fail to vest or for any other reason are not paid or delivered under the 2008 Plan will
again be available for subsequent awards under the 2008 Plan.
2000 Equity Incentive Plan
On April 19, 2000 the Board of Directors adopted our 2000 Equity Incentive Plan (2000 Plan) by
amending and restating our 1994 Equity Incentive Plan. The purpose of the 2000 Equity Incentive
Plan is to attract and retain qualified personnel, to provide additional incentives to our
employees, officers, consultants and employee directors and to promote the success of our business.
Pursuant to the 2000 Plan, we may grant or issue incentive stock options to employees and officers
and non-qualified stock options, rights to acquire restricted stock, restricted stock units, and
stock bonuses to consultants, employees, officers and non-employee directors.
The maximum term of a stock option under the 2000 Plan is eight years, but if the optionee at
the time of grant has voting power of more than 10% of our outstanding capital stock, the maximum
term of an incentive stock option is five years. The exercise price of incentive stock options
granted under the 2000 Equity Incentive Plan must be at least equal to 100% (or 110% with respect
to holders of more than 10% of the voting power of our outstanding capital stock) of the fair
market value of the stock subject to the option as determined by the closing price of our common
stock on the Nasdaq Global Market on the date of grant.
The Board may amend the 2000 Plan at any time, although certain amendments would require
stockholder approval. The 2000 Plan will terminate on February 9, 2010, unless earlier terminated
by the Board. On June 1, 2006, our stockholders approved an amendment to the 2000 Plan to increase
the number of shares of Common Stock authorized for issuance under the Purchase Plan to a total of
18,250,000 shares.
2000 Non-Officer Equity Incentive Plan
Our 1998 Non-Officer Equity Incentive Plan was adopted by the Board of Directors on August 18,
1998, and was amended and restated in its entirety and renamed the 2000 Non-officer Equity
Incentive Plan on June 6, 2000 ( 2000 Non-Officer Plan). The purpose of the 2000 Non-Officer Plan
is to attract and retain qualified personnel, to provide additional incentives to employees and
consultants and to promote the success of our business. Pursuant to the 2000 Non-Officer Plan, we
may grant or issue non-qualified stock options, rights to acquire restricted stock and stock
bonuses to employees and consultants who are neither Officers nor Directors of Nektar. The maximum
term of a stock option under the 2000 Non-Officer Plan is eight years. The exercise price of stock
options granted under the 2000 Non-Officer Plan are determined by the Board of Directors by
reference to closing price of our common stock on the Nasdaq Global Market.
Non-Employee Directors Stock Option Plan
On February 10, 1994, our Board of Directors adopted the Non-Employee Directors Stock Option
Plan under which options to purchase up to 400,000 shares of our Common Stock at the then fair
market value may be granted to our non-employee directors. There are no remaining options available
for grant under this plan as of December 31, 2008.
Restricted Stock Units
During the years ended December 31, 2008, 2007 and 2006, we issued Restricted Stock Unit
awards (RSU awards) to certain officers, non-employees, directors, employees and consultants. RSU
awards are similar to restricted stock in that they are issued for no consideration; however, the
holder generally is not entitled to the underlying shares of common stock until the RSU award
vests. Also, because the RSU awards are issued for $0.01, the grant-date fair value of the award is
equal to the intrinsic value of our common stock on the date of grant. The RSU awards were issued
under both the 2000 Plan and the 2000 Non-Officer Plan and are settled by delivery of shares of our
common stock on or shortly after the date the awards vest.
We issued approximately 48,000, 345,000 and 1,089,000 RSU awards during the years ended
December 31, 2008, 2007 and 2006. The RSU awards issued in 2008 and 2007 are service based awards
and vest based on the passage of time. Approximately 1,010,000 of the RSU awards issued in 2006
vest upon the achievement of three performance-based milestones. During the year ended December 31,
2007, one of the performance based milestones was achieved and 174,035 shares vested and were
released. Beginning with shares granted in the year ended December 31, 2005, each RSU award
depletes the pool of options available for grant under our equity incentive plans by a ratio of
1:1.5.
71
Employee Stock Purchase Plan
In February 1994, our Board of Directors adopted the Employee Stock Purchase Plan (ESPP),
pursuant to section 423(b) of the Internal Revenue Code of 1986. Under the ESPP, 800,000 shares of
common stock have been authorized for issuance. The terms of the ESPP provide eligible employees
with the opportunity to acquire an ownership interest in Nektar through participation in a program
of periodic payroll deductions for the purchase of our common stock. Employees may elect to enroll
or re-enroll in the plan on a semi-annual basis. Stock is purchased at 85% of the lower of the
closing price on the first day of the enrollment period or the last day of the enrollment period.
401(k) Retirement Plan
We sponsored a 401(k) retirement plan whereby eligible employees may elect to contribute up to
the lesser of 60% of their annual compensation or the statutorily prescribed annual limit allowable
under Internal Revenue Service regulations. The 401(k) plan permits us to make matching
contributions on behalf of all participants.
An amendment was made to the current 401(k) plan, effective January 1, 2008, to provide each
eligible participant with a base employer matching cash contribution of $1,000 and up to an
additional $2,000 in matching cash contributions (for a maximum aggregate of $3,000). The base
annual employer matching contribution of $1,000 accrues to the participant for participating at any
level in the 401(k) plan during the calendar year. The additional matching contribution accrues to
the participant on a $1 for $1 basis based upon each participants annual contribution to the
401(k) plan. In order for a participant to be eligible for any amount of the employer contribution
match, the participant must be an employee at the end of the calendar year. If the participant
commences employment during the calendar year, the base matching contribution will be pro-rated
based on the number of calendar quarters the participant is employed during the year. Both the
base and additional employer matching contribution are 100% vested on the date of the match.
In 2007 and 2006, we matched the lesser of 75% of year to date participant contributions or 3%
of eligible wages. The matching contribution is in the form of shares of our common stock
Vesting of the employer match, plus actual earnings thereon, is based on years of service.
Participants vest 33% in employer matching contributions each year with 100% vesting after three
years of service.
We issued approximately 161,000 shares and 103,000 shares of our common stock valued at
approximately $1.6 million and $1.8 million in connection with the employer matching common stock
contributions in 2007 and 2006 respectively. During part of 2007, shares reserved for issuance
related to matching contributions that had been previously been approved by our Board of Directors
became fully depleted. During the year ended December 31, 2007, our Board of Directors approved an
additional 300,000 shares to be reserved for issuance related to matching contributions.
Change in Control Severance Plan
On December 6, 2006, the Board of Directors approved a Change of Control Severance Benefit
Plan (CIC Plan) and on February 14, 2007 and October 21, 2008, the Board of Directors amended and
restated the CIC Plan. The CIC Plan is designed to make certain benefits available to eligible
employees of the Company in the event of a change of control of the Company and, following such
change of control, an employees employment with the Company or successor company is terminated in
certain specified circumstances. We adopted the CIC Plan to support the continuity of the business
in the context of a change of control transaction. The CIC Plan was not adopted in contemplation of
any specific change of control transaction. A brief description of the material terms and
conditions of the CIC Plan is provided below.
Under the CIC Plan, in the event of a change of control of the Company and a subsequent
termination of employment initiated by the Company or a successor company other than for Cause or
initiated by the employee for a Good Reason Resignation (as hereinafter defined) in each case
within twelve months following a change of control transaction, (i) the Chief Executive Officer
would be entitled to receive cash severance pay equal to 24 months base salary plus annual target
incentive pay, the extension of employee benefits over this severance period and the full
acceleration of unvested outstanding equity awards, and (ii) the Senior Vice Presidents and Vice
Presidents (including Principal Fellows) would each be entitled to receive cash severance pay equal
to twelve months base salary plus annual target incentive pay, the extension of employee benefits
over this severance period and the full acceleration of unvested outstanding equity awards. In the
event of a change of control of the Company and a subsequent termination of employment initiated by
the Company or a successor company other than for Cause (as hereinafter defined) within twelve
months following a change of control transaction, all other employees would each be entitled to
receive cash severance pay equal to 6 months base salary plus annual target incentive pay, the
extension of employee benefits over this severance period and the full acceleration of each such
employees unvested outstanding equity awards.
72
On December 6, 2006, the Board of Directors approved an amendment to all outstanding stock
awards held by non-employee directors to provide for full acceleration of vesting in the event of a
change of control transaction.
Note 10Collaborative Agreements
We have entered into various license and collaborative research and development agreements
with pharmaceutical and biotechnology companies. Under these arrangements, we are entitled to
receive license fees, up-front payments, milestone payments when and if certain development or
regulatory milestones are achieved, and/or reimbursement for research and development activities.
All of our research and development agreements are generally cancelable by our partners without
significant financial penalty to the partner. Revenues generated from our collaboration agreements
are recorded as Collaboration and other revenue and our costs of performing these services are
included in Research and development expense.
In accordance with these agreements, we recorded Collaboration and other revenue as follows
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
Partner |
|
Agreement |
|
2008 |
|
|
2007 |
|
|
2006 |
|
Novartis Vaccines and Diagnostics, Inc. |
|
Tobramycin inhalation powder (TIP) |
|
$ |
13,723 |
|
|
$ |
17,036 |
|
|
$ |
8,516 |
|
Bayer Schering Pharma AG |
|
Cipro Inhale |
|
|
11,653 |
|
|
|
8,116 |
|
|
|
4,884 |
|
Bayer Healthcare LLC |
|
BAY41-6651 (NKTR-061, Amikacin Inhale) |
|
|
10,054 |
|
|
|
1,306 |
|
|
|
|
|
Pfizer Inc. |
|
Exubera® inhalation powder |
|
|
|
|
|
|
49,490 |
|
|
|
33,674 |
|
|
|
Next-generation inhaled insulin (NGI) |
|
|
|
|
|
|
|
|
|
|
|
|
Other |
|
|
|
|
13,500 |
|
|
|
16,324 |
|
|
|
17,088 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration and other revenue |
|
|
|
$ |
48,930 |
|
|
$ |
92,272 |
|
|
$ |
64,162 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Novartis Vaccines and Diagnostics, Inc.
Tobramycin inhalation powder (TIP)
We were party to a collaborative research, development and commercialization agreement with
Novartis Vaccines and Diagnostics, Inc. related to the development of Tobramycin inhalation powder
(TIP) for the treatment of lung infections caused by the bacterium Pseudomonas aeruginosa in cystic
fibrosis patients. We were reimbursed for the cost of work performed on a revenue per annual
full-time equivalent (FTE) basis, plus out of pocket third party costs. Revenue recognized
approximates the cost associated with these billable services. We recognized $13.2 million,
$17.0 million, and $8.5 million in reimbursed research and development revenue during the years
ended December 31, 2008, 2007, and 2006.
Our collaborative research, development and commercialization agreement with Novartis Vaccines
and Diagnostics, Inc. for related to TIP was terminated on December 31, 2008. As part of the
termination, we relinquished its rights to future research and development funding and milestone
payments, as well as to any future royalty payments or manufacturing revenue.
Bayer Schering Pharma AG
Cipro Inhale
We were party to a collaborative research, development and commercialization agreement with
Bayer Schering Pharma AG related to the development of an inhaled powder formulation of Cipro
Inhale for the treatment of chronic lung infections caused by Pseudomonas aeruginosa in cystic
fibrosis patients. We were reimbursed for the cost of work performed on a revenue per annual FTE
basis, plus out of pocket third party costs. Revenue recognized approximates the cost associated
with these billable services. We recognized $10.3 million, $7.7 million, and $4.8 million in
reimbursed research and development revenue during the years ended December 31, 2008, 2007, and
2006.
As of December 31, 2008, we assigned the collaborative research, development and
commercialization agreement to Novartis Pharma AG. Pursuant to the terms of the Asset Purchase
Agreement with Novartis, we maintain the right to receive potential royalties in the future based
on net product sales if Cipro Inhale receives regulatory approval and is successfully
commercialized. See Note 11 to Notes to Consolidated Financial Statements for further information
on the pulmonary asset sale to Novartis.
73
Bayer Healthcare LLC
BAY41-6651 (NKTR-061, Amikacin Inhale)
On August 1, 2007, we entered into a co-development, license and co-promotion agreement with
Bayer Healthcare LLC to develop a specially-formulated inhaled Amikacin (BAY41-6651). We are
responsible for any future development of the nebulizer device included in the Amikacin product
through the completion of Phase 3 clinical trials and scale-up for commercialization. Bayer
Healthcare LLC is responsible for most future clinical development and commercialization costs, all
activities to support worldwide regulatory filings, approvals and related activities, further
development of BAY41-6651 and final product packaging. We received an up-front payment of $40.0
million in 2007 and performance milestone payments of $20.0 million, of which we have recognized
$10.1 million and $1.3 million during the years ended December 31, 2008 and 2007, respectively. We
are entitled to development milestones and sales milestones upon achievement of certain annual
sales targets and royalties based on annual worldwide net sales of BAY 41-6651.
Pfizer Inc.
Exubera ® inhalation powder and Next-generation inhaled insulin (NGI)
We were a party to collaboration agreements with Pfizer related to the development of Exubera
and the next-generation inhaled insulin that terminated on November 9, 2007. Under the terms of
the collaboration agreements, we received contract research and development revenue as well as
milestone and up-front fees related to the Exubera bulk powder insulin manufacturing, Exubera
inhaler device manufacturing through our contract manufacturers, and development related to NGI.
We were reimbursed for the cost of work performed on a revenue per annual FTE basis, plus out of
pocket third party costs. Revenue recognized approximates the cost associated with these billable
services. We recognized nil, $18.5 million, and $22.7 million, respectively, in reimbursed
research and development revenue during the years ended December 31, 2008, 2007, and 2006. Please
refer to Note 12 of Notes to Consolidated Financial Statements for further information on the
termination of our collaborative agreements with Pfizer Inc.
Note
11 Novartis Pulmonary Asset Sale
On December 31, 2008, we completed the sale of certain assets related to our pulmonary
business, associated technology and intellectual property to Novartis Pharma AG and Novartis
Pharmaceuticals Corporation (together referred to as Novartis) for a purchase price of $115.0
million in cash (the Novartis Pulmonary Asset Sale). Pursuant to the asset purchase agreement
entered between Novartis and us, we transferred to Novartis certain assets and obligations related
to our pulmonary technology, development and manufacturing operations including:
|
|
|
dry powder and liquid pulmonary technology platform including but not limited to our
pulmonary inhalation devices, formulation technology, manufacturing technology and related
intellectual property; |
|
|
|
manufacturing and associated development services payments for the Cipro Inhale program; |
|
|
|
|
manufacturing and royalty rights to the TIP program; |
|
|
|
|
capital equipment, information systems and facility lease obligations for our pulmonary
development and manufacturing facility in San Carlos, California; |
|
|
|
|
certain other interests that we had in two private companies, Pearl Therapeutics Inc. and
Stamford Devices Limited; and |
|
|
|
|
approximately 140 of our personnel primarily dedicated to our pulmonary technology,
development programs, and manufacturing operations, whom Novartis hired immediately
following the closing of the transaction. |
We have retained all of our rights to BAY41-6651 partnered with Bayer Healthcare LLC, certain
royalty rights on commercial sales of Cipro Inhale by Bayer Schering Pharma AG, all rights to the
ongoing development program for NKTR-063 and certain intellectual property rights specific to
inhaled insulin.
74
Gain on sale of pulmonary assets
On December 31, 2008, we recognized a Gain on sale of pulmonary assets for certain assets sold
to Novartis, which is comprised of the following (in thousands):
|
|
|
|
|
|
|
Year ended December 31, 2008 |
|
Proceeds from sale of certain pulmonary assets |
|
$ |
115,000 |
|
Transaction costs |
|
|
(4,609 |
) |
Net book value of property and equipment sold |
|
|
(37,291 |
) |
Equity investment in Pearl Therapeutics, net |
|
|
(2,658 |
) |
Goodwill related to pulmonary assets sold |
|
|
(1,930 |
) |
Other, net |
|
|
1,060 |
|
|
|
|
|
Gain on sale of pulmonary assets |
|
$ |
69,572 |
|
|
|
|
|
Additional Costs
In addition to the transaction costs recorded as part of the Gain on sale of pulmonary assets,
we expect to incur approximately $3.7 million to $4.2 million of additional costs in connection
with the Novartis Pulmonary Asset Sale, comprised of $1.9 million of one-time employee termination
costs, $1.0 million to $1.5 million to relocate our IT server room, and $0.8 million in other
costs. Under our Transition Service Agreement with Novartis, we have until December 31, 2009 to
relocate our server room. During 2008, we have recognized approximately $2.7 million of additional
costs incurred in our Statement of operations within Research and development expenses, of which we
paid $1.8 million.
Note 12 Termination of Pfizer Agreements and Inhaled Insulin Program
On November 9, 2007, we entered into a termination agreement and mutual release of our
collaborative development and license agreements agreement with Pfizer and all other related
agreements (Pfizer agreements). Under the termination agreement, we received a one-time payment of
$135.0 million in November 2007 from Pfizer in satisfaction of all outstanding contractual
obligations under our existing agreements relating to Exubera and NGI. Contractual obligations
included unbilled product sales and contract research revenue through November 9, 2007, outstanding
accounts receivable as of November 9, 2007, unrecovered capital costs at November 9, 2007, and
contract termination costs.
On February 12, 2008, we entered into a Termination and 2008 Continuation Agreement (TCA) with
Tech Group pursuant to which the manufacturing and supply agreement for the Exubera inhaler device
(Exubera Inhaler MSA) was terminated in its entirety and we agreed to pay Tech Group $13.8 million
in termination costs and $4.8 million in satisfaction of outstanding accounts payable. As part of
the TCA, we agreed to compensate Tech Group to retain a limited number of core Exubera inhaler
manufacturing personnel and its dedicated Exubera inhaler manufacturing facility for a limited
period in 2008. We also entered into a letter agreement with Pfizer to retain a limited number of
Exubera manufacturing personnel at Pfizers Terre Haute, Indiana manufacturing facility during
March and April 2008.
On February 14, 2008, we entered into a Termination and Mutual Release Agreement with Bespak
pursuant to which the Exubera Inhaler MSA was terminated in its entirety and we agreed to pay
Bespak £11.0 million, or approximately $21.6 million, including $3.0 million in satisfaction of
outstanding accounts payable and $18.6 million in termination costs and expenses that were due and
payable under the termination provisions of the Exubera Inhaler MSA, which included reimbursement
of inventory, inventory purchase commitments, unamortized depreciation on property and equipment,
severance costs and operating lease commitments.
On April 9, 2008, we announced that we had ceased all negotiations with potential partners for
Exubera and NGI as a result of new data analysis from ongoing clinical trials conducted by Pfizer
which indicated an increase in the number of new cases of lung cancer in Exubera patients who were
former smokers as compared to patients in the control group who were former smokers. Following
the termination of our inhaled insulin programs on April 9, 2008, we terminated our continuation
agreements with Tech Group and Pfizer.
75
Gain on Termination of Collaborative Agreements, Net
During the year ended December 31, 2007, we recognized a Gain on termination of collaborative
agreements, net which is comprised of the following (in thousands):
|
|
|
|
|
|
|
Year ended December 31, 2007 |
|
Pfizer termination settlement payment received |
|
$ |
135,000 |
|
Exubera Inhaler Manufacturing and Supply Agreement Termination |
|
|
|
|
Tech Group |
|
|
(13,765 |
) |
Bespak |
|
|
(18,598 |
) |
|
|
|
|
|
|
|
102,637 |
|
Settlement of assets and liabilities related to Pfizer |
|
|
(23,459 |
) |
|
|
|
|
Gain on termination of collaborative agreements, net |
|
$ |
79,178 |
|
|
|
|
|
Idle Exubera Manufacturing Capacity Costs
Idle Exubera manufacturing capacity costs, which is disclosed as a component of Other cost of
revenue, include costs payable to Pfizer and Tech Group under our continuation agreements and
internal salaries, benefits and stock-based compensation related to Exubera commercial
manufacturing employees, overhead at our San Carlos manufacturing facility, including rent,
utilities and maintenance and depreciation of property and equipment. We incurred these costs from
the termination of the Pfizer Agreements on November 9, 2007 through the termination of our inhaled
insulin programs in April 2008. For the years ended December 31, 2008 and 2007, we recognized
Cost of idle Exubera manufacturing capacity of $6.8 million and $6.3 million, respectively.
Accrued Expenses to Contract Manufacturers
As of December 31, 2007, we recorded $40.4 million of accrued expenses to Bespak and Tech
Group for outstanding accounts payable and termination costs and expenses that were due and payable
under the termination provisions of the Exubera Inhaler MSA. This liability was repaid in its
entirety in 2008. As of December 31, 2008, we have no further liabilities related to the Pfizer
Agreements.
Note 13Impairment of Long Lived Assets
During the years ended December 31, 2008, 2007, and 2006, we recorded the following charges in
the Impairment of long lived assets line item of our Consolidated Statements of Operations (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
Property and Equipment |
|
|
|
|
|
|
|
|
|
|
|
|
PEGylation manufacturing equipment |
|
$ |
1,458 |
|
|
$ |
|
|
|
$ |
|
|
Exubera-related |
|
|
|
|
|
|
28,396 |
|
|
|
|
|
Bradford, UK |
|
|
|
|
|
|
|
|
|
|
1,156 |
|
Construction in progress |
|
|
|
|
|
|
|
|
|
|
2,757 |
|
Aerogen core-technology intangible assets |
|
|
|
|
|
|
|
|
|
|
5,497 |
|
|
|
|
|
|
|
|
|
|
|
Impairment of long lived assets |
|
$ |
1,458 |
|
|
$ |
28,396 |
|
|
$ |
9,410 |
|
|
|
|
|
|
|
|
|
|
|
76
PEGylation manufacturing equipment
As of December 31, 2008, we determined that a specialized dryer used in our PEGylation
manufacturing facility was not functioning properly and is not being used in operations currently.
We performed an impairment analysis and determined the carrying value exceeded the fair value based
on a discounted cash flow model. As a result, we recorded an impairment loss for the net book
value of the equipment of $1.5 million.
Exubera-related property and equipment
On November 9, 2007, we entered into a termination agreement and mutual release with Pfizer
related to Exubera and NGI. As a result, we performed an impairment analysis of the property and
equipment that support Exubera commercial operations and NGI (Exubera-related assets), including
machinery and equipment at our contract manufacturer locations and machinery, equipment, and
leasehold improvements in San Carlos and determined the fair value based on a discounted cash flow
model. As of December 31, 2007, we concluded that the carrying value exceeded the estimated future
cash flow and recorded an impairment charge of $28.4 million for the Exubera-related assets. See
Note 12 for further discussion of the termination of the inhaled insulin programs.
Bradford UK property and equipment
In June 2006, we involuntarily terminated the majority of the personnel located at our
Bradford, UK site, commenced with plans to wind-down the location and its related operations, and
reassessed the useful life of the remaining laboratory and office equipment. We determined that
these assets could not be redeployed and had no future or alternative use. Due to our revised
estimate of the useful life of these assets, we accelerated approximately $1.2 million of remaining
depreciation in the year ended December 31, 2006.
Construction in progress
In December 2006, we determined that one of our construction-in-progress assets would no
longer be completed based on the contract renegotiation with one of our collaboration partners and
we recorded an impairment loss for the costs incurred to date of $2.8 million.
Aerogen core-technology intangible assets
As part of the October 2005 acquisition of Aerogen, Inc., we also acquired $7.2 million in
core technology intangible assets. In late December 2006, we entered into a non-binding letter of
intent to sell our general purpose nebulizer device business to the former management of Aerogen
Ireland, a wholly-owned subsidiary of Aerogen, Inc. During the year ended December 31, 2006, we
determined that the non-binding letter of intent to sell the general purpose nebulizer device
business, the anticipated proceeds of such potential sale, and the historical losses of the general
purposes nebulizer device business were indicators that this intangible asset did not have future
value and, as a result, we recorded a $5.5 million impairment charge.
Note 14Workforce Reduction Plans
In an effort to reduce ongoing operating costs and improve our organizational structure,
efficiency and productivity, we executed workforce reduction plans in May 2007 (2007 Plan) and
February 2008 (2008 Plan) designed to streamline the company, consolidate corporate functions, and
strengthen decision-making and execution within our business units.
The 2007 Plan reduced our workforce by approximately 180 full-time employees, or approximately
25 percent of our regular full-time employees. The 2008 Plan reduced our workforce by
approximately 110 employees, or approximately 20 percent of our regular full-time employees. The
2007 Plan and the 2008 Plan cost approximately $8.4 million and $5.0 million, respectively,
comprised of cash payments for severance, medical insurance, and outplacement services. Both
plans were substantially complete at December 31, 2008.
For the years ended December 31, 2008 and 2007, workforce reduction charges were recorded in
our Consolidated Financial Statements as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
Cost of goods sold, net of inventory change |
|
$ |
148 |
|
|
$ |
974 |
|
Other cost of revenue |
|
|
1,221 |
|
|
|
|
|
Research and development expense |
|
|
3,087 |
|
|
|
5,791 |
|
General and administrative expense |
|
|
517 |
|
|
|
1,617 |
|
|
|
|
|
|
|
|
Total workforce reduction charges |
|
$ |
4,973 |
|
|
$ |
8,382 |
|
|
|
|
|
|
|
|
77
The following table summarizes the liabilities associated with the 2007 Plan and the 2008 Plan
included in Accrued compensation in our Consolidated Balance Sheets as of December 31, 2008 and
December 31, 2007, and the activity during the year ended December 31, 2008 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 Plan |
|
|
2008 Plan |
|
|
Total |
|
Balance at December 31, 2007 |
|
$ |
580 |
|
|
$ |
|
|
|
$ |
580 |
|
Charges |
|
|
|
|
|
|
4,973 |
|
|
|
4,973 |
|
Payments |
|
|
(580 |
) |
|
|
(4,868 |
) |
|
|
(5,448 |
) |
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
$ |
|
|
|
$ |
105 |
|
|
$ |
105 |
|
|
|
|
|
|
|
|
|
|
|
Note 15Stock-Based Compensation
We issue stock-based awards from three equity incentive plans, which are more fully described
in Note 9 Stockholders Equity. Stock-based compensation cost is recorded in the following line
items of our Consolidated Financial Statements:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
Cost of goods sold, net of change in inventory |
|
$ |
269 |
|
|
$ |
1,003 |
|
|
$ |
1,614 |
|
Research and development |
|
|
4,642 |
|
|
|
6,275 |
|
|
|
9,692 |
|
General and administrative |
|
|
4,960 |
|
|
|
5,915 |
|
|
|
17,837 |
|
|
|
|
|
|
|
|
|
|
|
Total compensation cost for share-based arrangements |
|
$ |
9,871 |
|
|
$ |
13,193 |
|
|
$ |
29,143 |
|
|
|
|
|
|
|
|
|
|
|
For the years ended December 31, 2008, 2007, and 2006, we recorded approximately $2.2 million,
$0.5 million, and $11.8 million, respectively, of stock-based compensation expense related to
modifications of certain stock grants in connection with employment separation agreements.
Generally, the modifications extended the option holders exercise period beyond the 90 day period
after termination and accelerated a portion of the option holders unvested grants. Stock-based
compensation charges are non-cash charges and as such have no impact on our financial position or
reported cash flows.
Aggregate Unrecognized Stock-based Compensation Expense
As of December 31, 2008, total unrecognized compensation expense related to unvested
stock-based compensation arrangements under the Options Plans is expected to be recognized over a
weighted-average period of 1.98 years as follows (in thousands):
|
|
|
|
|
|
|
As of |
|
|
|
December 31, |
|
Fiscal Year |
|
2008 |
|
2009 |
|
$ |
8,080 |
|
2010 |
|
|
6,845 |
|
2011 |
|
|
5,662 |
|
2012 and thereafter |
|
|
966 |
|
|
|
|
|
|
|
$ |
21,553 |
|
|
|
|
|
Black-Scholes Assumptions
The following tables list the Black-Scholes assumptions used to calculate the fair value of
employee stock options and ESPP purchases.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, 2008 |
|
|
Year ended December 31, 2007 |
|
|
Year ended December 31, 2006 |
|
|
|
Employee |
|
|
|
|
|
|
Employee |
|
|
|
|
|
|
Employee |
|
|
|
|
|
|
Stock Options |
|
|
ESPP |
|
|
Stock Options |
|
|
ESPP |
|
|
Stock Options |
|
|
ESPP |
|
Average risk-free interest rate |
|
|
2.5 |
% |
|
|
2.00 |
% |
|
|
4.2 |
% |
|
|
4.8 |
% |
|
|
4.8 |
% |
|
|
5.2 |
% |
Dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
Volatility factor |
|
|
51.58 |
% |
|
|
72.34 |
% |
|
|
53.3 |
% |
|
|
38.4 |
% |
|
|
63.1 |
% |
|
|
33.3 |
% |
Weighted average expected life |
|
4.97 years |
|
|
0.5 years |
|
|
5.09 years |
|
|
0.5 years |
|
|
5.20 years |
|
|
0.5 years |
|
78
Generally the stock-based grants have expected terms ranging from 30 months to 61 months. For
the period ended December 31, 2008, the annual forfeiture rate for directors, employee options, and
employee RSU awards was estimated to be 0%, 11%, and 25% respectively. For the twelve months ended
December 31, 2007 and 2006, the annual forfeiture rate for executives and staff was estimated to be
4.7% and 7.4%, respectively, based on our qualitative and quantitative analysis of our historical
forfeitures.
The grant date fair value of RSU awards is always equal to the intrinsic value of the award on
the date of grant since the awards were issued for no consideration. The weighted average life of
the 2008, 2007, and 2006 RSU awards is estimated to be 0.8 years, 1.2 years, and 3.0 years,
respectively.
Summary of Stock Option Activity
The table below presents a summary of stock option activity under the 2000 Equity Incentive
Plan, the Non-Employee Directors Stock Option Plan, and the 2000 Non-Officer Equity Incentive Plan
(in thousands, except for price per share information):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Average |
|
|
|
|
|
|
Options Outstanding |
|
|
Exercise |
|
|
Remaining |
|
|
Aggregate |
|
|
|
Number of |
|
|
Exercise Price |
|
|
Price |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
Shares |
|
|
Per Share |
|
|
Per Share |
|
|
Life (in years) |
|
|
Value (1) |
|
Balance at December 31, 2005 |
|
|
13,253 |
|
|
$ |
0.0161.63 |
|
|
$ |
17.85 |
|
|
|
5.38 |
|
|
$ |
37,678 |
|
Options granted |
|
|
1,115 |
|
|
|
14.3621.51 |
|
|
|
17.88 |
|
|
|
|
|
|
|
|
|
Options exercised |
|
|
(2,160 |
) |
|
|
0.0520.41 |
|
|
|
9.51 |
|
|
|
|
|
|
$ |
18,651 |
|
Options forfeited & canceled |
|
|
(1,501 |
) |
|
|
4.6252.16 |
|
|
|
21.86 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006 |
|
|
10,707 |
|
|
$ |
0.0161.63 |
|
|
$ |
18.97 |
|
|
|
4.78 |
|
|
$ |
15,348 |
|
Options granted |
|
|
5,257 |
|
|
|
5.9815.24 |
|
|
|
9.87 |
|
|
|
|
|
|
|
|
|
Options exercised |
|
|
(429 |
) |
|
|
0.0114.25 |
|
|
|
6.80 |
|
|
|
|
|
|
$ |
1,770 |
|
Options forfeited & canceled |
|
|
(3,323 |
) |
|
|
4.5055.19 |
|
|
|
18.47 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007 |
|
|
12,212 |
|
|
$ |
0.0161.63 |
|
|
$ |
15.62 |
|
|
|
5.20 |
|
|
$ |
643 |
|
Options granted |
|
|
6,180 |
|
|
|
2.837.13 |
|
|
|
6.02 |
|
|
|
|
|
|
|
|
|
Options exercised |
|
|
(39 |
) |
|
|
0.037.33 |
|
|
|
5.72 |
|
|
|
|
|
|
$ |
42 |
|
Options forfeited & canceled |
|
|
(4,802 |
) |
|
|
0.0161.63 |
|
|
|
12.93 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
|
13,551 |
|
|
$ |
0.0160.88 |
|
|
$ |
12.13 |
|
|
|
4.84 |
|
|
$ |
2,032 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at December 31, 2008 |
|
|
7,144 |
|
|
|
|
|
|
$ |
16.57 |
|
|
|
2.89 |
|
|
$ |
276 |
|
Exercisable at December 31, 2007 |
|
|
7,023 |
|
|
|
|
|
|
$ |
19.15 |
|
|
|
3.64 |
|
|
$ |
584 |
|
Exercisable at December 31, 2006 |
|
|
8,185 |
|
|
|
|
|
|
$ |
19.88 |
|
|
|
4.09 |
|
|
$ |
12,229 |
|
|
|
|
(1) |
|
Aggregate Intrinsic Value represents the difference between the exercise price of the option
and the closing market price of our common stock on the exercise date or December 31, as
applicable. |
The weighted-average grant-date fair value of options granted during the years ended December
31, 2008, 2007, and 2006 was $2.79, $5.11, and $10.54, respectively. The estimated fair value of
options that vested during the years ended December 31, 2008, 2007, and 2006 was $9.8 million, $8.7
million, and $12.0 million, respectively.
The following table provides information regarding our outstanding stock options as of
December 31, 2008 (in thousands except for price per share information and contractual life):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
|
Options Exercisable |
|
Range of |
|
|
|
|
|
Weighted-Average |
|
|
Weighted-Average |
|
|
|
|
|
|
Weighted-Average |
|
Exercise |
|
|
|
|
|
Exercise Price Per |
|
|
Remaining Contractual |
|
|
|
|
|
|
Exercise Price Per |
|
Prices |
|
Number of Shares |
|
|
Share |
|
|
Life (in years) |
|
|
Number of Shares |
|
|
Share |
|
$0.01 $4.83 |
|
|
1,505 |
|
|
$ |
4.34 |
|
|
|
7.40 |
|
|
|
38 |
|
|
$ |
0.20 |
|
$4.90 $6.46 |
|
|
1,376 |
|
|
$ |
5.99 |
|
|
|
6.24 |
|
|
|
521 |
|
|
$ |
5.97 |
|
$6.50 $6.65 |
|
|
2,590 |
|
|
$ |
6.65 |
|
|
|
5.99 |
|
|
|
499 |
|
|
$ |
6.65 |
|
$6.66 $7.58 |
|
|
1,463 |
|
|
$ |
7.01 |
|
|
|
5.99 |
|
|
|
568 |
|
|
$ |
7.04 |
|
$7.63 $11.86 |
|
|
1,423 |
|
|
$ |
9.86 |
|
|
|
4.64 |
|
|
|
970 |
|
|
$ |
9.88 |
|
$12.30 $14.52 |
|
|
1,626 |
|
|
$ |
13.97 |
|
|
|
3.74 |
|
|
|
1,162 |
|
|
$ |
13.90 |
|
$14.53 $19.29 |
|
|
1,373 |
|
|
$ |
17.55 |
|
|
|
3.47 |
|
|
|
1,216 |
|
|
$ |
17.62 |
|
$19.40 $27.88 |
|
|
1,864 |
|
|
$ |
26.16 |
|
|
|
1.99 |
|
|
|
1,839 |
|
|
$ |
26.24 |
|
$27.96 $60.88 |
|
|
331 |
|
|
$ |
37.91 |
|
|
|
1.12 |
|
|
|
331 |
|
|
$ |
37.91 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,551 |
|
|
$ |
12.13 |
|
|
|
4.84 |
|
|
|
7,144 |
|
|
$ |
16.57 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
79
Summary of RSU Award Activity
During 2008, we issued 47,900 RSU awards, respectively to certain officers on a time-based
vesting schedule. Expense for these awards is recognized ratably over the underlying time-based
vesting period and will settle by delivery of shares of our common stock on or shortly after the
date the awards vest. The RSU awards become fully vested over a period of 12 months. We are
expensing the grant date fair value of the awards ratably over the service period.
During 2007, we issued 344,811 RSU awards, respectively to certain officers and employees on a
time-based vesting schedule. Expense for these awards is recognized ratably over the underlying
time-based vesting period and will settle by delivery of shares of our common stock on or shortly
after the date the awards vest. The RSU awards become fully vested over a period of 12 to 48
months. We are expensing the grant date fair value of the awards ratably over the service period.
During 2006, we issued RSU awards totaling 1,088,300 shares of our common stock to certain
employees and directors. The RSU awards are settled by delivery of shares of our common stock on or
shortly after the date the awards vest. A significant portion of these awards vest based upon
achieving three pre-determined performance milestones which were initially expected to occur over a
period of 40 months. We are expensing the grant date fair value of the awards ratably over the
expected performance period.
One of the three milestones was achieved during the three-month period ended June 30, 2007 and
approximately 174,000 shares were vested and released. During 2007, we determined that the second
milestone would not be met. As a result, we reversed all previously recorded compensation expense
related to this performance milestone, approximately $2.8 million, in the third quarter of 2007.
Based on our current drug candidate development efforts, we currently estimate that the achievement
of the third performance milestone is probable by the third quarter in 2011. If our actual
experience in future periods differs from these current estimates, we may change our determination
of the probability of achieving the performance milestone or the estimate of the period in which
the milestone will be achieved.
A summary of RSU award activity is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average |
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining |
|
|
Weighted-Average |
|
|
Aggregate |
|
|
|
|
|
|
|
contractual Life |
|
|
Grant-Date |
|
|
Intrinsic |
|
|
|
Units Issued |
|
|
(in years) |
|
|
Fair value(1) |
|
|
Value |
|
Balance at December 31, 2005 |
|
|
284 |
|
|
|
1.14 |
|
|
|
|
|
|
$ |
4,676 |
|
Granted |
|
|
1,088 |
|
|
|
|
|
|
$ |
19.55 |
|
|
|
|
|
Released |
|
|
(178 |
) |
|
|
|
|
|
|
|
|
|
$ |
3,184 |
|
Forfeited & Canceled |
|
|
(110 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006 |
|
|
1,084 |
|
|
|
1.52 |
|
|
|
|
|
|
$ |
16,479 |
|
Granted |
|
|
345 |
|
|
|
|
|
|
$ |
11.01 |
|
|
|
|
|
Released |
|
|
(334 |
) |
|
|
|
|
|
|
|
|
|
$ |
3,808 |
|
Forfeited & Canceled |
|
|
(360 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007 |
|
|
735 |
|
|
|
2.03 |
|
|
|
|
|
|
$ |
4,925 |
|
Granted |
|
|
48 |
|
|
|
|
|
|
$ |
5.26 |
|
|
|
|
|
Released |
|
|
(107 |
) |
|
|
|
|
|
|
|
|
|
$ |
487 |
|
Forfeited & Canceled |
|
|
(411 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
|
265 |
|
|
|
2.48 |
|
|
|
|
|
|
$ |
1,472 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Fair value represents the difference between the exercise price of the award and the closing
market price of our common stock on the release date or the year ended December 31, 2008 as
applicable. |
80
Note 16Income Taxes
For financial reporting purposes, Loss before provision for income taxes, includes the
following components (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
Domestic |
|
$ |
(69,350 |
) |
|
$ |
(30,143 |
) |
|
$ |
(147,059 |
) |
Foreign |
|
|
34,208 |
|
|
|
(1,309 |
) |
|
|
(6,874 |
) |
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
(35,142 |
) |
|
$ |
(31,452 |
) |
|
$ |
(153,933 |
) |
|
|
|
|
|
|
|
|
|
|
As of December 31, 2008, we had a net operating loss carryforward for federal income tax
purposes of approximately $720.6 million, portions of which will begin to expire in 2009. We had a
total state net operating loss carryforward of approximately $423.1 million, which will begin to
expire in 2010. Due to the discontinuation of our Bradford, UK operations, we no longer have a
foreign net operating loss carryforward available as of December 31, 2008.
Utilization of the federal and state net operating loss and credit carryforwards may be
subject to a substantial annual limitation due to the change in ownership provisions of the
Internal Revenue Code of 1986 and similar state provisions. The annual limitation may result in the
expiration of net operating losses and credits before utilization.
The provision (benefit) for income taxes consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
Current: |
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
$ |
(970 |
) |
|
$ |
194 |
|
|
$ |
|
|
State |
|
|
(69 |
) |
|
|
782 |
|
|
|
6 |
|
Foreign |
|
|
519 |
|
|
|
333 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Current |
|
|
(520 |
) |
|
|
1,309 |
|
|
|
6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred: |
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
|
|
|
|
|
|
|
|
|
|
|
State |
|
|
|
|
|
|
|
|
|
|
822 |
|
Foreign |
|
|
(286 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Deferred |
|
|
(286 |
) |
|
|
|
|
|
|
822 |
|
|
|
|
|
|
|
|
|
|
|
Provision (Benefit) for income taxes |
|
$ |
(806 |
) |
|
$ |
1,309 |
|
|
$ |
828 |
|
|
|
|
|
|
|
|
|
|
|
81
Income tax provision (benefit) related to continuing operations differs from the amounts
computed by applying the statutory income tax rate of 35% to pretax loss as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
U.S. federal provision (benefit) |
|
|
|
|
|
|
|
|
|
|
|
|
At statutory rate |
|
$ |
(12,300 |
) |
|
$ |
(10,998 |
) |
|
$ |
(52,337 |
) |
State taxes |
|
|
(69 |
) |
|
|
782 |
|
|
|
6 |
|
Change in valuation allowance |
|
|
29,768 |
|
|
|
27,829 |
|
|
|
50,385 |
|
Foreign tax differential |
|
|
(11,754 |
) |
|
|
|
|
|
|
|
|
Foreign subsidiary investment |
|
|
(4,777 |
) |
|
|
|
|
|
|
|
|
Unrecognized tax credits |
|
|
(2,366 |
) |
|
|
(13,109 |
) |
|
|
|
|
Capital lease true-up |
|
|
(1,431 |
) |
|
|
|
|
|
|
|
|
Expiring tax attributes |
|
|
1,508 |
|
|
|
|
|
|
|
|
|
Non-deductible employee compensation |
|
|
14 |
|
|
|
210 |
|
|
|
2,138 |
|
Sale of Irish subsidiary |
|
|
|
|
|
|
(3,604 |
) |
|
|
|
|
Investment impairment and non-deductible amortization |
|
|
|
|
|
|
|
|
|
|
636 |
|
Other |
|
|
601 |
|
|
|
199 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
(806 |
) |
|
$ |
1,309 |
|
|
$ |
828 |
|
|
|
|
|
|
|
|
|
|
|
Deferred income taxes reflect the net tax effects of loss and credit carryforwards and
temporary differences between the carrying amounts of assets and liabilities for financial
reporting purposes and the amounts used for income tax purposes. Significant components of our
deferred tax assets for federal and state income taxes are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Deferred tax assets: |
|
|
|
|
|
|
|
|
Net operating loss carryforwards |
|
$ |
289,631 |
|
|
$ |
254,419 |
|
Research and other credits |
|
|
50,350 |
|
|
|
47,274 |
|
Capitalized research expenses |
|
|
4,563 |
|
|
|
6,670 |
|
Deferred revenue |
|
|
28,659 |
|
|
|
11,050 |
|
Depreciation |
|
|
|
|
|
|
7,423 |
|
Reserve and accruals |
|
|
9,629 |
|
|
|
24,495 |
|
Stock based compensation |
|
|
20,315 |
|
|
|
16,375 |
|
Capital loss carryforward |
|
|
|
|
|
|
3,918 |
|
Other |
|
|
5,163 |
|
|
|
6,170 |
|
|
|
|
|
|
|
|
Deferred tax assets before valuation allowance |
|
|
408,310 |
|
|
|
377,794 |
|
Valuation allowance for deferred tax assets |
|
|
(402,907 |
) |
|
|
(375,318 |
) |
|
|
|
|
|
|
|
Total deferred tax assets |
|
$ |
5,403 |
|
|
$ |
2,476 |
|
|
|
|
|
|
|
|
Deferred tax liabilities: |
|
|
|
|
|
|
|
|
Depreciation |
|
|
(1,479 |
) |
|
|
|
|
Acquisition related intangibles |
|
|
(3,352 |
) |
|
|
(2,476 |
) |
Other |
|
|
(286 |
) |
|
|
|
|
|
|
|
|
|
|
|
Total deferred tax liabilities |
|
$ |
(5,117 |
) |
|
$ |
(2,476 |
) |
|
|
|
|
|
|
|
Net deferred tax assets |
|
$ |
286 |
|
|
$ |
|
|
|
|
|
|
|
|
|
Realization of our deferred tax assets is dependent upon future earnings, if any, the timing
and amount of which are uncertain. Because of our lack of U.S. earnings history, the net U.S.
deferred tax assets have been fully offset by a valuation allowance. The valuation allowance
increased by $27.6 million and $52.8 million during the years ended December 31, 2008 and 2007,
respectively. The valuation allowance includes approximately $35.6 million of benefit as of
December 31, 2008 and December 31, 2007 related to stock based compensation and exercises, prior to
the implementation of SFAS No. 123R, that will be credited to additional paid in capital when
realized. We have federal research credits of approximately $20.8 million, which will begin to
expire in 2009 and state research credits of approximately $16.8 million which have no expiration
date. We have federal orphan drug credits of $12.8 million which will expire in 2024.
82
Undistributed earnings of our foreign subsidiary in India are considered to be permanently
reinvested and accordingly, no deferred U.S. income taxes have been provided thereon. Upon
distribution of those earnings in the form of dividends or otherwise, we would be subject to U.S.
income tax.
In July 2006, the FASB issued Interpretation No. 48, Accounting for Uncertainty in Income
Taxes. This interpretation, among other things, creates a two-step approach for evaluating
uncertain tax positions. Recognition occurs when an enterprise concludes that a tax position, based
on its technical merits, is more-likely-than-not to be sustained upon examination. Measurement
determines the amount of benefit that more-likely-than-not will be realized. De-recognition of a
tax position that was previously recognized would occur when a company subsequently determines that
a tax position no longer meets the more-likely-than-not threshold of being sustained. FIN 48
specifically prohibits the use of a valuation allowance as a substitute for de-recognition of tax
positions, and it has expanded disclosure requirements.
As of December 31, 2008 and December 31, 2007, we had $11.7 million and $9.2 million,
respectively, of unrecognized tax benefits. We historically accrued for uncertain tax positions in
deferred tax assets as we have been in a net operating loss position since inception and any
adjustments to our tax positions would result in an adjustment of our net operating loss or tax
credit carry forwards rather than resulting in a cash outlay. If we are eventually able to
recognize these uncertain positions, our effective tax rate would be reduced. We currently have a
full valuation allowance against our net deferred tax asset which would impact the timing of the
effective tax rate benefit should any of these uncertain tax positions be favorably settled in the
future.
It is reasonably possible that certain unrecognized tax benefits may increase or decrease
within the next twelve months due to tax examination changes, settlement activities, expirations of
statute of limitations, or the impact on recognition and measurement considerations related to the
results of published tax cases or other similar activities. We do not anticipate any significant
changes to unrecognized tax benefits over the next 12 months.
Our policy is to include interest and penalties related to unrecognized tax benefits, if any,
within the provision for taxes in the consolidated condensed statements of operations under the
provisions of FIN 48. During the years ended December 31, 2008 and 2007, no interest or penalties
were required to be recognized relating to unrecognized tax benefits.
We file income tax returns in the U.S., as well as California, Alabama, and various foreign
jurisdictions. We are currently not the subject of any income tax examinations. In general, the
earliest open year subject to examination is 2005 for U.S. and Alabama and 2004 for California,
although depending upon jurisdiction, tax years may remain open subject to limitations. We have
evaluated the need for additional tax reserves for any audits as part of our FIN 48 adoption
process.
We have the following activity relating to unrecognized tax benefits (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Beginning balance |
|
$ |
9,222 |
|
|
$ |
7,176 |
|
Tax positions related to current year |
|
|
|
|
|
|
|
|
Additions |
|
|
2,438 |
|
|
|
2,046 |
|
Reductions |
|
|
|
|
|
|
|
|
Tax positions related to prior year |
|
|
|
|
|
|
|
|
Additions |
|
|
|
|
|
|
|
|
Reductions |
|
|
|
|
|
|
|
|
Settlements |
|
|
|
|
|
|
|
|
Lapses in statute of limitations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ending balance |
|
$ |
11,660 |
|
|
$ |
9,222 |
|
|
|
|
|
|
|
|
83
Note 17Segment Reporting
We operate in one business segment which focuses on applying our technology platforms to
improve the performance of established and novel medicines. We operate in one segment because our
business offerings have similar economics and other characteristics, including the nature of
products and production processes, types of customers, distribution methods and regulatory
environment. We are comprehensively managed as one business segment by our Chief Executive Officer
and his management team. Within our one business segment we have two components, PEGylation
technology and pulmonary technology.
Our revenue is derived primarily from clients in the pharmaceutical and biotechnology
industries. Four of our customers, Bayer (including Bayer Healthcare LLC and Bayer Schering Pharma
AG), UCB Pharma, Novartis, and Roche represented 24%, 16%, 15%, and 14%, respectively, of our total
revenue during the year ended December 31, 2008. Due to the termination of our collaborative
agreements with Pfizer, we did not receive any revenue from Pfizer in 2008 related to Exubera or
NGI. Revenue from Pfizer Inc. represented 69% and 64% of our revenue for the years ended December
31, 2007 and 2006, respectively.
Revenue by geographic area is based on the shipping locations of the customers. The following
table sets forth revenue by geographic area (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2006 |
|
United States |
|
$ |
30,800 |
|
|
$ |
212,990 |
|
|
$ |
182,959 |
|
European countries |
|
|
59,385 |
|
|
|
60,037 |
|
|
|
33,471 |
|
All other countries |
|
|
|
|
|
|
|
|
|
|
1,288 |
|
|
|
|
|
|
|
|
|
|
|
Total Revenue |
|
$ |
90,185 |
|
|
$ |
273,027 |
|
|
$ |
217,718 |
|
|
|
|
|
|
|
|
|
|
|
At December 31, 2008, $69.2 million, or approximately 94%, of the net book value of our
property and equipment was located in the United States and $4.4 million, or approximately 6%, was
located in India. At December 31, 2007, approximately 98% of the net book value of our property
and equipment of $114.4 million was located in the United States.
Note 18Selected Quarterly Financial Data (Unaudited)
The following table sets forth certain unaudited quarterly financial data. In our opinion, the
unaudited information set forth below has been prepared on the same basis as the audited
information and includes all adjustments necessary to present fairly the information set forth
herein. We have experienced fluctuations in our quarterly results. We expect these fluctuations to
continue in the future. Due to these and other factors, we believe that quarter-to-quarter
comparisons of our operating results will not be meaningful, and you should not rely on our results
for one quarter as an indication of our future performance. Certain items previously reported in
specific financial statement captions have been reclassified to conform to the current period
presentation. Such reclassifications have not impacted previously reported revenues, operating loss
or net loss. All data is in thousands except per share information.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year 2008 |
|
|
Fiscal Year 2007 |
|
|
|
Q1 |
|
|
Q2 |
|
|
Q3 |
|
|
Q4 |
|
|
Q1 |
|
|
Q2 |
|
|
Q3 |
|
|
Q4 |
|
Product sales and royalty revenue (1) |
|
$ |
10,371 |
|
|
$ |
9,010 |
|
|
$ |
9,474 |
|
|
$ |
12,400 |
|
|
$ |
71,355 |
|
|
$ |
47,001 |
|
|
$ |
35,697 |
|
|
$ |
26,702 |
|
Collaboration and other revenue |
|
$ |
9,621 |
|
|
$ |
11,392 |
|
|
$ |
11,965 |
|
|
$ |
15,952 |
|
|
$ |
13,661 |
|
|
$ |
18,916 |
|
|
$ |
20,624 |
|
|
$ |
39,071 |
|
Gross margin on product sales |
|
$ |
3,144 |
|
|
$ |
3,566 |
|
|
$ |
4,125 |
|
|
$ |
2,204 |
|
|
$ |
15,727 |
|
|
$ |
8,626 |
|
|
$ |
9,391 |
|
|
$ |
9,315 |
|
Research and development expenses |
|
$ |
37,373 |
|
|
$ |
33,500 |
|
|
$ |
38,265 |
|
|
$ |
45,279 |
|
|
$ |
37,492 |
|
|
$ |
41,000 |
|
|
$ |
35,773 |
|
|
$ |
39,310 |
|
General and administrative expenses (2) |
|
$ |
11,947 |
|
|
$ |
13,329 |
|
|
$ |
12,386 |
|
|
$ |
13,835 |
|
|
$ |
16,971 |
|
|
$ |
13,415 |
|
|
$ |
12,663 |
|
|
$ |
14,233 |
|
Impairment of long lived assets |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
1,458 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
28,396 |
|
Gain on sale of pulmonary assets |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
(69,572 |
) |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Gain on termination of collaborative agreements, net |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
(79,178 |
) |
Operating income (loss) |
|
$ |
(41,889 |
) |
|
$ |
(33,358 |
) |
|
$ |
(34,561 |
) |
|
$ |
27,156 |
|
|
$ |
(25,969 |
) |
|
$ |
(27,988 |
) |
|
$ |
(19,572 |
) |
|
$ |
37,381 |
|
Interest expense |
|
$ |
3,918 |
|
|
$ |
3,929 |
|
|
$ |
3,988 |
|
|
$ |
3,357 |
|
|
$ |
4,933 |
|
|
$ |
4,702 |
|
|
$ |
4,773 |
|
|
$ |
4,230 |
|
Gain on extinguishment of debt |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
50,149 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Net income (loss) |
|
$ |
(40,705 |
) |
|
$ |
(33,375 |
) |
|
$ |
(37,038 |
) |
|
$ |
76,782 |
|
|
$ |
(25,673 |
) |
|
$ |
(27,510 |
) |
|
$ |
(18,620 |
) |
|
$ |
39,042 |
|
Basic and diluted net income (loss) per share (3)(4) |
|
$ |
(0.44 |
) |
|
$ |
(0.36 |
) |
|
$ |
(0.40 |
) |
|
$ |
0.83 |
|
|
$ |
(0.28 |
) |
|
$ |
(0.30 |
) |
|
$ |
(0.20 |
) |
|
$ |
0.42 |
|
|
|
|
(1) |
|
Exubera commercialization readiness revenue was reclassified from Product sales and royalties
to Collaboration and other revenue. |
|
(2) |
|
Amortization of other intangible assets was previously separately disclosed, but has been
combined with General and administrative expenses for the years ended December 31, 2008, 2007,
and 2006. |
|
(3) |
|
Quarterly loss per share amounts may not total the year-to-date loss per share due to
rounding. |
|
(4) |
|
During the fourth quarter of 2008 and 2007, there were approximately 81 dilutive shares and
578 dilutive shares, respectively, outstanding which did not change earnings per share. |
84
SCHEDULE II
NEKTAR THERAPEUTICS
VALUATION AND QUALIFYING ACCOUNTS AND RESERVES
YEARS ENDED DECEMBER 31, 2008, 2007, and 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Charged to |
|
|
|
|
|
|
|
|
|
|
Balance at |
|
|
Costs and |
|
|
|
|
|
|
Balance At |
|
|
|
Beginning |
|
|
Expenses, |
|
|
|
|
|
|
End |
|
Description |
|
of Year |
|
|
Net of Reversals |
|
|
Utilizations |
|
|
of Year |
|
|
|
(In thousands) |
|
2008: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for doubtful accounts |
|
$ |
33 |
|
|
$ |
61 |
|
|
$ |
(2 |
) |
|
$ |
92 |
|
Allowance for inventory reserves |
|
$ |
5,772 |
|
|
$ |
2,668 |
|
|
$ |
(3,451 |
) |
|
$ |
4,989 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for doubtful accounts |
|
$ |
357 |
|
|
$ |
(16 |
) |
|
$ |
(308 |
) |
|
$ |
33 |
|
Allowance for inventory reserves |
|
$ |
4,160 |
|
|
$ |
4,670 |
|
|
$ |
(3,058 |
) |
|
$ |
5,772 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for doubtful accounts |
|
$ |
70 |
|
|
$ |
380 |
|
|
$ |
(93 |
) |
|
$ |
357 |
|
Allowance for inventory reserves |
|
$ |
3,068 |
|
|
$ |
2,592 |
|
|
$ |
(1,500 |
) |
|
$ |
4,160 |
|
85
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
Not applicable.
Item 9A. Controls and Procedures
Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information
required to be disclosed in our Securities Exchange Act reports is recorded, processed, summarized
and reported within the time periods specified in the SECs rules and forms, and that such
information is accumulated and communicated to management, including our Chief Executive Officer
and Chief Financial Officer, as appropriate, to allow timely decisions regarding required financial
disclosure.
As of the end of the period covered by this report, we carried out an evaluation, under the
supervision and with the participation of our management, including the Chief Executive Officer and
the Chief Financial Officer, of the effectiveness of the design and operation of our disclosure
controls and procedures pursuant to Exchange Act Rule 13a-15. Based upon, and as of the date of,
this evaluation, the Chief Executive Officer and the Chief Financial Officer concluded that our
disclosure controls and procedures were effective. Accordingly, management believes that the
financial statements included in this report fairly present in all material respects our financial
condition, results of operations and cashflows for the periods presented.
Managements Annual Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over
financial reporting, as such term is defined in Exchange Act Rule 13a-15(f). Our internal control
over financial reporting is a process designed to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of financial statements for external
purposes in accordance with GAAP.
Our management has assessed the effectiveness of our internal control over financial reporting
as of December 31, 2008. In making its assessment of internal control over financial reporting,
management used the criteria described in Internal ControlIntegrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission.
Based on our evaluation under the framework described in Internal ControlIntegrated
Framework, our management concluded that our internal control over financial reporting was
effective as of December 31, 2008.
The effectiveness of our internal control over financial reporting as of December 31, 2008 has
been audited by an independent registered public accounting firm, as stated in their report, which
is included herein.
Changes in Internal Control Over Financial Reporting
We continuously seek to improve the efficiency and effectiveness of our internal controls.
This results in refinements to processes throughout the Company. In October 2008, we completed the
implementation of an upgraded enterprise resource planning (ERP) system designed and implemented to
make our financial reporting more efficient and integrated across our enterprise. The
implementation of the ERP system did not result in changes to our controls over financial
reporting. As a result, there was no change in our internal control over financial reporting
during the quarter ended December 31, 2008, which was identified in connection with our
managements evaluation required by Exchange Act Rules 13a-15(f) and 15d-15(f) that has materially
affected, or is reasonably likely to materially affect, our internal control over financial
reporting.
Inherent Limitations on the Effectiveness of Controls
Our management, including the Chief Executive Officer and Chief Financial Officer, does not
expect that our disclosure controls and procedures or our internal control over financial reporting
will prevent all error and all fraud. A control system, no matter how well conceived and operated,
can provide only reasonable, not absolute, assurance that the objectives of the control system are
met. Because of the inherent limitations in all control systems, no evaluation of controls can
provide absolute assurance that all control issues and instances of fraud, if any, within the
company have been detected. These inherent limitations include the realities that judgments in
decision making can be faulty and that breakdowns can occur because of simple error or mistake.
Additionally, controls can be circumvented by the individual acts of some persons, by collusion of
two or more people or by management override of the control. The design of any system of controls
also is based in part upon certain assumptions about the likelihood of future events, and there can
be no assurance that any design will succeed in achieving its stated goals under all potential
future conditions. Over time, controls may become inadequate because of changes in conditions, or
the degree of compliance with the policies or procedures may deteriorate. Because of the inherent
limitations in a cost-effective control system, misstatements due to error or fraud may occur and
not be detected.
Item 9B. Other Information
None.
86
PART III
Item 10. Directors, Executive Officers and Corporate Governance
Information relating to our executive officers required by this item is set forth in Part
IItem 1 of this report under the caption Executive Officers of the Registrant and is
incorporated herein by reference. The other information required by this Item is incorporated by
reference from the definitive proxy statement for our 2009 Annual Meeting of Stockholders to be
filed with the SEC pursuant to Regulation 14A (Proxy Statement) not later than 120 days after the
end of the fiscal year covered by this Form 10-K under the captions Corporate Governance and Board
of Directors, Proposal 1Election of Directors and Section 16(a) Beneficial Ownership
Reporting Compliance.
Information regarding our audit committee financial expert will be set forth in the Proxy
Statement under the caption Audit Committee, which information is incorporated herein by
reference.
In December 2003, we adopted a Code of Business Conduct and Ethics applicable to all
employees, including the principal executive officer, principal financial officer and principal
accounting officer or controller, or persons performing similar functions. The Code of Business
Conduct and Ethics is posted on our website at www.nektar.com. Amendments to, and waivers from, the
Code of Business Conduct and Ethics that apply to any of these officers, or persons performing
similar functions, and that relate to any element of the code of ethics definition enumerated in
Item 406(b) of Regulation S-K will be disclosed at the website address provided above and, to the
extent required by applicable regulations, on a current report on Form 8-K.
As permitted by SEC Rule 10b5-1, certain of our executive officers, directors and other
employees have set up a predefined, structured stock trading program with their broker to sell our
stock. The stock trading program allows a broker acting on behalf of the executive officer,
director or other employee to trade our stock during blackout periods or while such executive
officer, director or other employee may be aware of material, nonpublic information, if the trade
is performed according to a pre-existing contract, instruction or plan that was established with
the broker during a non-blackout period and when such executive officer, director or employee was
not aware of any material, nonpublic information. Our executive officers, directors and other
employees may also trade our stock outside of the stock trading programs set up under Rule 10b5-1
subject to our blackout periods and insider trading rules.
Item 11. Executive Compensation
The information required by this Item is included in the Proxy Statement and incorporated
herein by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder
Matters
The information required by this Item is included in the Proxy Statement and incorporated
herein by reference.
Item 13. Certain Relationships and Related Transactions and Director Independence
The information required by this Item is included in the Proxy Statement and incorporated
herein by reference.
Item 14. Principal Accountant Fees and Services
The information required by this Item is included in the Proxy Statement and incorporated
herein by reference.
87
PART IV
Item 15. Exhibits, Financial Statement Schedules
(a) The following documents are filed as part of this report:
(1) Consolidated Financial Statements:
The following financial statements are filed as part of this report under Item 8 Financial
Statements and Supplementary Data.
|
|
|
|
|
|
|
Page |
|
Reports of Independent Registered Public Accounting Firm |
|
|
53 |
|
Consolidated Balance Sheets at December 31, 2008 and 2007 |
|
|
55 |
|
Consolidated Statements of Operations for each of the three years in the period ended December 31, 2008 |
|
|
56 |
|
Consolidated Statements of Stockholders Equity for each of the three years in the period ended December 31, 2008 |
|
|
57 |
|
Consolidated Statements of Cash Flows for each of the three years in the period ended December 31, 2008 |
|
|
58 |
|
Notes to Consolidated Financial Statements |
|
|
59 |
|
(2) Financial Statement Schedules:
Schedule II, Valuation and Qualifying Accounts and Reserves, is filed as part of this Annual
Report on Form 10-K. All other financial statement schedules have been omitted because they are not
applicable, or the information required is presented in our consolidated financial statements and
notes thereto under Item 8 of this Annual Report on Form 10-K.
(3) Exhibits.
Except as so indicated in Exhibit 32.1, the following exhibits are filed as part of, or
incorporated by reference into, this Annual Report on Form 10-K.
|
|
|
|
|
|
|
|
|
Exhibit |
|
|
|
|
|
|
Number |
|
|
|
|
|
Description of Documents |
|
|
|
|
|
|
|
|
|
|
2.1 |
|
|
|
(23 |
) |
|
Asset Purchase Agreement, dated October 20, 2008, by and between Nektar Therapeutics, a Delaware
corporation, AeroGen, Inc., a Delaware corporation and wholly-owned subsidiary of Nektar Therapeutics,
Novartis Pharmaceuticals Corporation, a Delaware corporation, and Novartis Pharma AG, a Swiss
corporation+ |
|
|
|
|
|
|
|
|
|
|
3.1 |
|
|
|
(1 |
) |
|
Certificate of Incorporation of Inhale Therapeutic Systems (Delaware), Inc. |
|
|
|
|
|
|
|
|
|
|
3.2 |
|
|
|
(2 |
) |
|
Certificate of Amendment of the Amended Certificate of Incorporation of Inhale Therapeutic Systems, Inc. |
|
|
|
|
|
|
|
|
|
|
3.3 |
|
|
|
(3 |
) |
|
Certificate of Designation of Series A Junior Participating Preferred Stock of Nektar Therapeutics |
|
|
|
|
|
|
|
|
|
|
3.4 |
|
|
|
(4 |
) |
|
Certificate of Designation of Series B Convertible Preferred Stock of Nektar Therapeutics |
|
|
|
|
|
|
|
|
|
|
3.5 |
|
|
|
(5 |
) |
|
Certificate of Ownership and Merger of Nektar Therapeutics |
|
|
|
|
|
|
|
|
|
|
3.6 |
|
|
|
(6 |
) |
|
Amended and Restated Bylaws of Nektar Therapeutics |
|
|
|
|
|
|
|
|
|
|
4.1 |
|
|
|
|
|
|
Reference is made to Exhibits 3.1, 3.2, 3.3, 3.4, 3.5 and 3.6 |
|
|
|
|
|
|
|
|
|
|
4.2 |
|
|
|
(5 |
) |
|
Specimen Common Stock certificate |
|
|
|
|
|
|
|
|
|
|
4.3 |
|
|
|
(3 |
) |
|
Rights Agreement, dated as of June 1, 2001, by and between Nektar Therapeutics and Mellon Investor
Services LLC, as Rights Agent |
|
|
|
|
|
|
|
|
|
|
4.4 |
|
|
|
(3 |
) |
|
Form of Right Certificate |
|
|
|
|
|
|
|
|
|
|
4.5 |
|
|
|
(7 |
) |
|
Indenture, dated September 28, 2005, by and between Nektar Therapeutics, as Issuer, and J.P. Morgan
Trust Company, National Association, as Trustee |
|
|
|
|
|
|
|
|
|
|
4.6 |
|
|
|
(7 |
) |
|
Registration Right Agreement, dated as of September 28, 2005, among Nektar Therapeutics and entities
named therein |
88
|
|
|
|
|
|
|
|
|
Exhibit |
|
|
|
|
|
|
Number |
|
|
|
|
|
Description of Documents |
|
|
|
|
|
|
|
|
|
|
10.1 |
|
|
|
(8 |
) |
|
1994 Non-Employee Directors Stock Option Plan, as amended++ |
|
|
|
|
|
|
|
|
|
|
10.2 |
|
|
|
(9 |
) |
|
1994 Employee Stock Purchase Plan, as amended and restated++ |
|
|
|
|
|
|
|
|
|
|
10.3 |
|
|
|
(10 |
) |
|
2000 Non-Officer Equity Incentive Plan, as amended and restated++ |
|
|
|
|
|
|
|
|
|
|
10.4 |
|
|
|
(11 |
) |
|
Form of 2000 Non-Officer Equity Incentive Plan Stock Option
Agreement (Nonstatutory Stock Option)++ |
|
|
|
|
|
|
|
|
|
|
10.5 |
|
|
|
(11 |
) |
|
Form of 2000 Non-Officer Equity Incentive Plan Stock Option Agreement (Nonstatutory (Unapproved) Stock
Option)++ |
|
|
|
|
|
|
|
|
|
|
10.6 |
|
|
|
(12 |
) |
|
Forms of 2000 Non-Officer Equity Incentive Plan Restricted Stock Unit Grant Notice and Restricted Stock
Unit Agreement++ |
|
|
|
|
|
|
|
|
|
|
10.7 |
|
|
|
(13 |
) |
|
2000 Equity Incentive Plan, as amended and restated++ |
|
|
|
|
|
|
|
|
|
|
10.8 |
|
|
|
(14 |
) |
|
Form of Stock Option Agreement under the 2000 Equity Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.9 |
|
|
|
(12 |
) |
|
Forms
of Restricted Stock Unit Grant Notice and Restricted Stock Unit
Agreement under the 2000 Equity
Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.10 |
|
|
|
(15 |
) |
|
Form of Non-Employee Director Stock Option Agreement under the 2000 Equity Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.11 |
|
|
|
(15 |
) |
|
Form of Non-Employee Director Restricted Stock Unit Agreement under the 2000 Equity Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.12 |
|
|
|
(15 |
) |
|
Employment Transition and Separation Release Agreement, executed effective on September 4, 2007, with
Louis Drapeau++ |
|
|
|
|
|
|
|
|
|
|
10.13 |
|
|
|
(15 |
) |
|
Employment Transition and Separation Release Agreement, executed effective on October 5, 2007, with
David Johnston++ |
|
|
|
|
|
|
|
|
|
|
10.14 |
|
|
|
(22 |
) |
|
Compensation Plan for Non-Employee Directors, as amended and restated++ |
|
|
|
|
|
|
|
|
|
|
10.15 |
|
|
|
(10 |
) |
|
401(k) Retirement Plan++ |
|
|
|
|
|
|
|
|
|
|
10.16 |
|
|
|
(22 |
) |
|
2008 Discretionary Performance-Based Incentive Compensation Policy++ |
|
|
|
|
|
|
|
|
|
|
10.17 |
|
|
|
(23 |
) |
|
Amended and Restated Change of Control Severance Benefit Plan++ |
|
|
|
|
|
|
|
|
|
|
10.18 |
|
|
|
(17 |
) |
|
Transition and Retirement Agreement, dated March 13, 2006, with Ajit S. Gill++ |
|
|
|
|
|
|
|
|
|
|
10.19 |
|
|
|
(18 |
) |
|
Letter Amendment, dated October 5, 2006, with Ajit S. Gill, amending that certain Transition and
Retirement Agreement, dated March 13, 2006, with Mr. Gill++ |
|
|
|
|
|
|
|
|
|
|
10.20 |
|
|
|
(23 |
) |
|
2008 Equity Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.21 |
|
|
|
(23 |
) |
|
Forms
of Stock Option Grant Notice and of Stock Option Agreement under the 2008 Equity Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.22 |
|
|
|
(23 |
) |
|
Forms
of Restricted Stock Unit Grant Notice and Restricted Stock Unit
Agreement under the 2008 Equity
Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.23 |
|
|
|
(19 |
) |
|
Separation and General Release Agreement, dated November 17, 2008, with John S. Patton++ |
|
|
|
|
|
|
|
|
|
|
10.24 |
|
|
|
(20 |
) |
|
Bonus and General Release Agreement, dated December 27, 2008, with Nevan C. Elam++ |
|
|
|
|
|
|
|
|
|
|
10.25 |
|
|
|
(15 |
) |
|
Form of Severance Letter for executive officers of the company++ |
|
|
|
|
|
|
|
|
|
|
10.26 |
|
|
|
(23 |
) |
|
Amended and Restated Letter Agreement, executed effective on December 1, 2008, with Howard W. Robin++ |
|
|
|
|
|
|
|
|
|
|
10.27 |
|
|
|
(23 |
) |
|
Amended and Restated Letter Agreement, executed effective on December 1, 2008, with John Nicholson++ |
|
|
|
|
|
|
|
|
|
|
10.28 |
|
|
|
(23 |
) |
|
Amended and Restated Letter Agreement, executed effective on December 1, 2008, with Bharatt M.
Chowrira, Ph.D., J.D.++ |
89
|
|
|
|
|
|
|
|
|
Exhibit |
|
|
|
|
|
|
Number |
|
|
|
|
|
Description of Documents |
|
|
|
|
|
|
|
|
|
|
10.29 |
|
|
|
(23 |
) |
|
Amended and Restated Letter Agreement, executed effective on December 1, 2008, with Dr. Randall
Moreadith++ |
|
|
|
|
|
|
|
|
|
|
10.30 |
|
|
|
(15 |
) |
|
Amended and Restated Built-to-Suite Lease between Nektar Therapeutics and BMR-201 Industrial Road LLC,
dated August 17, 2004, as amended on January 11, 2005 and July 19, 2007 |
|
|
|
|
|
|
|
|
|
|
10.31 |
|
|
|
(21 |
) |
|
Settlement Agreement and General Release, dated June 30, 2006, by and between The Board of Trustees of
the University of Alabama, The University of Alabama in Huntsville, Nektar Therapeutics AL Corporation
(a wholly-owned subsidiary of Nektar Therapeutics), Nektar Therapeutics and J. Milton Harris |
|
|
|
|
|
|
|
|
|
|
10.32 |
|
|
|
(15 |
) |
|
Co-Development, License and Co-Promotion Agreement, dated August 1, 2007, between Nektar Therapeutics
(and its subsidiaries) and Bayer Healthcare LLC+ |
|
|
|
|
|
|
|
|
|
|
10.33 |
|
|
|
(16 |
) |
|
Termination Agreement and Mutual Release, dated November 9, 2007, between Nektar Therapeutics and
Pfizer Inc.+ |
|
|
|
|
|
|
|
|
|
|
10.34 |
|
|
|
(23 |
) |
|
Exclusive Research, Development, License and Manufacturing and Supply Agreement, by and among Nektar AL
Corporation, Baxter Healthcare SA, and Baxter Healthcare Corporation, dated September 26, 2005, as
amended+ |
|
|
|
|
|
|
|
|
|
|
10.35 |
|
|
|
(23 |
) |
|
Exclusive License Agreement, dated December 31, 2008, between Nektar Therapeutics, a Delaware
corporation, and Novartis Pharma AG, a Swiss corporation+ |
|
|
|
|
|
|
|
|
|
|
21.1 |
|
|
|
(23 |
) |
|
Subsidiaries of Nektar Therapeutics |
|
|
|
|
|
|
|
|
|
|
23.1 |
|
|
|
(23 |
) |
|
Consent of Independent Registered Public Accounting Firm |
|
|
|
|
|
|
|
|
|
|
24 |
|
|
|
|
|
|
Power of Attorney (reference is made to the signature page) |
|
|
|
|
|
|
|
|
|
|
31.1 |
|
|
|
(23 |
) |
|
Certification of Nektar Therapeutics principal executive officer required by Rule 13a-14(a) or Rule
15d-14(a) |
|
|
|
|
|
|
|
|
|
|
31.2 |
|
|
|
(23 |
) |
|
Certification of Nektar Therapeutics principal financial officer required by Rule 13a-14(a) or Rule
15d-14(a) |
|
|
|
|
|
|
|
|
|
|
32.1 |
* |
|
|
(23 |
) |
|
Section 1350 Certifications |
|
|
|
+ |
|
Confidential treatment with respect to specific portions of this
Exhibit has been requested, and such portions are omitted and have
been filed separately with the SEC. |
|
++ |
|
Management contract or compensatory plan or arrangement. |
|
* |
|
Exhibit 32.1 is being furnished and shall not be deemed to be filed for purposes of Section
18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability
of that section, nor shall such exhibit be deemed to be incorporated by reference in any
registration statement or other document filed under the Securities Act of 1933, as amended,
or the Securities Exchange Act, except as otherwise stated in such filing. |
|
(1) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 1998. |
|
(2) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 2000. |
|
(3) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on June 4, 2001. |
|
(4) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on January 8, 2002. |
|
(5) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on January 23, 2003. |
|
(6) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on December 12, 2007. |
|
(7) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on September 28, 2005. |
90
|
|
|
(8) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 1996. |
|
(9) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Registration
Statement on Form S-8 (No. 333-98321), filed on August 19, 2002. |
|
(10) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 2004. |
|
(11) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Registration
Statement on Form S-8 (No. 333-71936), filed on October 19, 2001, as amended. |
|
(12) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Annual Report on
Form 10-K, as amended, for the year ended December 31, 2005. |
|
(13) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on June 7, 2006. |
|
(14) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended September 30, 2000. |
|
(15) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended September 30, 2007. |
|
(16) |
|
Incorporated by reference to the indicated exhibit in Nektar
Therapeutics Annual Report on
Form 10-K for the year ended December 31, 2007. |
|
(17) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K/A, filed on March 16, 2006. |
|
(18) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended September 30, 2006. |
|
(19) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on November 21, 2008. |
|
(20) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on January 2, 2009. |
|
(21) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 2006. |
|
(22) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended March 31, 2008. |
|
(23) |
|
Filed herewith. |
91
SIGNATURES
Pursuant to the Securities Exchange Act of 1934, the Registrant has duly caused this report to
be signed on its behalf by the undersigned, thereunto duly authorized, in the City of San Carlos,
County of San Mateo, State of California on March 6, 2009.
|
|
|
|
|
|
By: |
/s/ John Nicholson
|
|
|
|
John Nicholson |
|
|
|
Senior Vice President and Chief Financial Officer |
|
|
|
|
|
By: |
/s/ Jillian B. Thomsen
|
|
|
|
Jillian B. Thomsen |
|
|
|
Vice President and Chief Accounting Officer |
|
92
POWER OF ATTORNEY
KNOW ALL PERSON BY THESE PRESENTS, that each person whose signature appears below constitutes
and appoints John Nicholson and Jillian B. Thomsen and each of them, as his or her true and lawful
attorneys-in-fact and agents, with full power of substitution and resubstitution, for him or her
and in his or her name, place and stead, in any and all capacities, to sign any and all amendments
to this Annual Report on Form 10-K and to file the same, with all exhibits thereto and other
documents in connection therewith, with the Securities and Exchange Commission, granting unto said
attorneys-in-fact and agents and each of them, full power and authority to do and perform each and
every act and thing requisite and necessary to be done in connection therewith, as fully to all
intents and purposes as he or she might or could do in person, hereby ratify and confirming all that said
attorneys-in-fact and agents, or any of them, or their or his or her substitute or substitutes, may
lawfully do or cause to be done by virtue hereof.
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, this
report has been signed by the following persons in the capacities and on the dates indicated:
|
|
|
|
|
SIGNATURE |
|
TITLE |
|
DATE |
|
|
|
|
|
/s/ Howard W. Robin
Howard W. Robin
|
|
Chief Executive Officer, President and Director (Principal
Executive Officer)
|
|
March 6, 2009 |
|
|
|
|
|
/s/ John Nicholson
John Nicholson
|
|
Senior Vice President and Chief Financial Officer (Principal
Financial Officer)
|
|
March 6, 2009 |
|
|
|
|
|
/s/ Jillian B, Thomsen
Jillian B. Thomsen
|
|
Vice President Finance and Chief Accounting Officer (Principal
Accounting Officer)
|
|
March 6, 2009 |
|
|
|
|
|
/s/ Robert B. Chess
Robert B. Chess
|
|
Director, Chairman of the Board of Directors
|
|
March 6, 2009 |
|
|
|
|
|
/s/ Michael A. Brown
Michael A. Brown
|
|
Director
|
|
March 6, 2009 |
|
|
|
|
|
/s/ Hoyoung Huh
Hoyoung Huh
|
|
Director
|
|
March 6, 2009 |
|
|
|
|
|
/s/ Joseph J. Krivulka
Joseph J. Krivulka
|
|
Director
|
|
March 6, 2009 |
|
|
|
|
|
/s/ Christopher A. Kuebler
Christopher A. Kuebler
|
|
Director
|
|
March 6, 2009 |
|
|
|
|
|
/s/ Lutz Lingnau
Lutz Lingnau
|
|
Director
|
|
March 6, 2009 |
|
|
|
|
|
/s/ Susan Wang
Susan Wang
|
|
Director
|
|
March 6, 2009 |
|
|
|
|
|
/s/ Roy A. Whitfield
Roy A. Whitfield
|
|
Director
|
|
March 6, 2009 |
93
Except as so indicated in Exhibit 32.1, the following exhibits are filed as part of, or
incorporated by reference into, this Annual Report on Form 10-K.
|
|
|
|
|
|
|
|
|
Exhibit |
|
|
|
|
|
|
Number |
|
|
|
|
|
Description of Documents |
|
|
|
|
|
|
|
|
|
|
2.1 |
|
|
|
(23 |
) |
|
Asset Purchase Agreement, dated October 20, 2008, by and between Nektar Therapeutics, a Delaware
corporation, AeroGen, Inc., a Delaware corporation and wholly-owned subsidiary of Nektar Therapeutics,
Novartis Pharmaceuticals Corporation, a Delaware corporation, and Novartis Pharma AG, a Swiss
corporation+ |
|
|
|
|
|
|
|
|
|
|
3.1 |
|
|
|
(1 |
) |
|
Certificate of Incorporation of Inhale Therapeutic Systems (Delaware), Inc. |
|
|
|
|
|
|
|
|
|
|
3.2 |
|
|
|
(2 |
) |
|
Certificate of Amendment of the Amended Certificate of Incorporation of Inhale Therapeutic Systems, Inc. |
|
|
|
|
|
|
|
|
|
|
3.3 |
|
|
|
(3 |
) |
|
Certificate of Designation of Series A Junior Participating Preferred Stock of Nektar Therapeutics |
|
|
|
|
|
|
|
|
|
|
3.4 |
|
|
|
(4 |
) |
|
Certificate of Designation of Series B Convertible Preferred Stock of Nektar Therapeutics |
|
|
|
|
|
|
|
|
|
|
3.5 |
|
|
|
(5 |
) |
|
Certificate of Ownership and Merger of Nektar Therapeutics |
|
|
|
|
|
|
|
|
|
|
3.6 |
|
|
|
(6 |
) |
|
Amended and Restated Bylaws of Nektar Therapeutics |
|
|
|
|
|
|
|
|
|
|
4.1 |
|
|
|
|
|
|
Reference is made to Exhibits 3.1, 3.2, 3.3, 3.4, 3.5 and 3.6 |
|
|
|
|
|
|
|
|
|
|
4.2 |
|
|
|
(5 |
) |
|
Specimen Common Stock certificate |
|
|
|
|
|
|
|
|
|
|
4.3 |
|
|
|
(3 |
) |
|
Rights Agreement, dated as of June 1, 2001, by and between Nektar Therapeutics and Mellon Investor
Services LLC, as Rights Agent |
|
|
|
|
|
|
|
|
|
|
4.4 |
|
|
|
(3 |
) |
|
Form of Right Certificate |
|
|
|
|
|
|
|
|
|
|
4.5 |
|
|
|
(7 |
) |
|
Indenture, dated September 28, 2005, by and between Nektar Therapeutics, as Issuer, and J.P. Morgan
Trust Company, National Association, as Trustee |
|
|
|
|
|
|
|
|
|
|
4.6 |
|
|
|
(7 |
) |
|
Registration Right Agreement, dated as of September 28, 2005, among Nektar Therapeutics and entities
named therein |
|
|
|
|
|
|
|
|
|
|
10.1 |
|
|
|
(8 |
) |
|
1994 Non-Employee Directors Stock Option Plan, as amended++ |
|
|
|
|
|
|
|
|
|
|
10.2 |
|
|
|
(9 |
) |
|
1994 Employee Stock Purchase Plan, as amended and restated++ |
|
|
|
|
|
|
|
|
|
|
10.3 |
|
|
|
(10 |
) |
|
2000 Non-Officer Equity Incentive Plan, as amended and restated++ |
|
|
|
|
|
|
|
|
|
|
10.4 |
|
|
|
(11 |
) |
|
Form of 2000 Non-Officer Equity Incentive
Plan Stock Option Agreement (Nonstatutory Stock Option)++ |
|
|
|
|
|
|
|
|
|
|
10.5 |
|
|
|
(11 |
) |
|
Form of 2000 Non-Officer Equity Incentive Plan Stock Option Agreement (Nonstatutory (Unapproved) Stock
Option)++ |
|
|
|
|
|
|
|
|
|
|
10.6 |
|
|
|
(12 |
) |
|
Forms of 2000 Non-Officer Equity Incentive Plan Restricted Stock Unit Grant Notice and Restricted Stock
Unit Agreement++ |
|
|
|
|
|
|
|
|
|
|
10.7 |
|
|
|
(13 |
) |
|
2000 Equity Incentive Plan, as amended and restated++ |
|
|
|
|
|
|
|
|
|
|
10.8 |
|
|
|
(14 |
) |
|
Form of Stock Option Agreement under the 2000 Equity Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.9 |
|
|
|
(12 |
) |
|
Forms
of Restricted Stock Unit Grant Notice and Restricted Stock Unit
Agreement under the 2000 Equity
Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.10 |
|
|
|
(15 |
) |
|
Form of Non-Employee Director Stock Option Agreement under the 2000 Equity Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.11 |
|
|
|
(15 |
) |
|
Form of Non-Employee Director Restricted Stock Unit Agreement under the 2000 Equity Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.12 |
|
|
|
(15 |
) |
|
Employment Transition and Separation Release Agreement, executed effective on September 4, 2007, with
Louis Drapeau++ |
|
|
|
|
|
|
|
|
|
|
10.13 |
|
|
|
(15 |
) |
|
Employment Transition and Separation Release Agreement, executed effective on October 5, 2007, with
David Johnston++ |
|
|
|
|
|
|
|
|
|
94
|
|
|
|
|
|
|
|
|
Exhibit |
|
|
|
|
|
|
Number |
|
|
|
|
|
Description of Documents |
|
|
|
|
|
|
|
|
|
|
10.14 |
|
|
|
(22 |
) |
|
Compensation Plan for Non-Employee Directors, as amended and restated++ |
|
|
|
|
|
|
|
|
|
|
10.15 |
|
|
|
(10 |
) |
|
401(k) Retirement Plan++ |
|
|
|
|
|
|
|
|
|
|
10.16 |
|
|
|
(22 |
) |
|
2008 Discretionary Performance-Based Incentive Compensation Policy++ |
|
|
|
|
|
|
|
|
|
|
10.17 |
|
|
|
(23 |
) |
|
Amended and Restated Change of Control Severance Benefit Plan++ |
|
|
|
|
|
|
|
|
|
|
10.18 |
|
|
|
(17 |
) |
|
Transition and Retirement Agreement,
dated March 13, 2006, with Ajit S. Gill++ |
|
|
|
|
|
|
|
|
|
|
10.19 |
|
|
|
(18 |
) |
|
Letter Amendment, dated October 5, 2006, with Ajit S. Gill, amending that certain Transition and Retirement Agreement, dated March 13, 2006, with Mr. Gill++ |
|
|
|
|
|
|
|
|
|
|
10.20 |
|
|
|
(23 |
) |
|
2008 Equity Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.21 |
|
|
|
(23 |
) |
|
Form of Stock Option Agreement under the 2008 Equity Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.22 |
|
|
|
(23 |
) |
|
Forms
of Restricted Stock Unit Grant Notice and Restricted Stock Unit
Agreement under the 2008 Equity
Incentive Plan++ |
|
|
|
|
|
|
|
|
|
|
10.23 |
|
|
|
(19 |
) |
|
Separation and General Release Agreement, dated November 17, 2008, with John S. Patton++ |
|
|
|
|
|
|
|
|
|
|
10.24 |
|
|
|
(20 |
) |
|
Bonus and General Release Agreement, dated December 27, 2008, with Nevan C. Elam++ |
|
|
|
|
|
|
|
|
|
|
10.25 |
|
|
|
(15 |
) |
|
Form of Severance Letter for executive officers of the company++ |
|
|
|
|
|
|
|
|
|
|
10.26 |
|
|
|
(23 |
) |
|
Amended and Restated Letter Agreement, executed effective on December 1, 2008, with Howard W. Robin++ |
|
|
|
|
|
|
|
|
|
|
10.27 |
|
|
|
(23 |
) |
|
Amended and Restated Letter Agreement, executed effective on December 1, 2008, with John Nicholson++ |
|
|
|
|
|
|
|
|
|
|
10.28 |
|
|
|
(23 |
) |
|
Amended and Restated Letter Agreement, executed effective on December 1, 2008, with Bharatt M.
Chowrira, Ph.D., J.D.++ |
|
|
|
|
|
|
|
|
|
|
10.29 |
|
|
|
(23 |
) |
|
Amended and Restated Letter Agreement, executed effective on December 1, 2008, with Dr. Randall
Moreadith++ |
|
|
|
|
|
|
|
|
|
|
10.30 |
|
|
|
(15 |
) |
|
Amended and Restated Built-to-Suite Lease between Nektar Therapeutics and BMR-201 Industrial Road LLC,
dated August 17, 2004, as amended on January 11, 2005 and July 19, 2007 |
|
|
|
|
|
|
|
|
|
|
10.31 |
|
|
|
(21 |
) |
|
Settlement Agreement and General Release, dated June 30, 2006, by and between The Board of Trustees of
the University of Alabama, The University of Alabama in Huntsville, Nektar Therapeutics AL Corporation
(a wholly-owned subsidiary of Nektar Therapeutics), Nektar Therapeutics and J. Milton Harris |
|
|
|
|
|
|
|
|
|
|
10.32 |
|
|
|
(15 |
) |
|
Co-Development, License and Co-Promotion Agreement, dated August 1, 2007, between Nektar Therapeutics
(and its subsidiaries) and Bayer Healthcare LLC+ |
|
|
|
|
|
|
|
|
|
|
10.33 |
|
|
|
(16 |
) |
|
Termination Agreement and Mutual Release, dated November 9, 2007, between Nektar Therapeutics and
Pfizer Inc.+ |
|
|
|
|
|
|
|
|
|
|
10.34 |
|
|
|
(23 |
) |
|
Exclusive Research, Development, License and Manufacturing and Supply Agreement, by and among Nektar AL
Corporation, Baxter Healthcare SA, and Baxter Healthcare Corporation, dated September 26, 2005, as
amended+ |
|
|
|
|
|
|
|
|
|
|
10.35 |
|
|
|
(23 |
) |
|
Exclusive License Agreement, dated December 31, 2008, between Nektar Therapeutics, a Delaware
corporation, and Novartis Pharma AG, a Swiss corporation+ |
|
|
|
|
|
|
|
|
|
|
21.1 |
|
|
|
(23 |
) |
|
Subsidiaries of Nektar Therapeutics |
|
|
|
|
|
|
|
|
|
|
23.1 |
|
|
|
(23 |
) |
|
Consent of Independent Registered Public Accounting Firm |
95
|
|
|
|
|
|
|
|
|
Exhibit |
|
|
|
|
|
|
Number |
|
|
|
|
|
Description of Documents |
|
|
|
|
|
|
|
|
|
|
24 |
|
|
|
|
|
|
Power of Attorney (reference is made to the signature page) |
|
|
|
|
|
|
|
|
|
|
31.1 |
|
|
|
(23 |
) |
|
Certification of Nektar Therapeutics principal executive officer required by Rule 13a-14(a) or Rule
15d-14(a) |
|
|
|
|
|
|
|
|
|
|
31.2 |
|
|
|
(23 |
) |
|
Certification of Nektar Therapeutics principal financial officer required by Rule 13a-14(a) or Rule
15d-14(a) |
|
|
|
|
|
|
|
|
|
|
32.1 |
* |
|
|
(23 |
) |
|
Section 1350 Certifications |
|
|
|
+ |
|
Confidential treatment with respect to specific portions of this
Exhibit has been requested, and such portions are omitted and have
been filed separately with the SEC.
|
|
++ |
|
Management contract or compensatory plan or arrangement. |
|
* |
|
Exhibit 32.1 is being furnished and shall not be deemed to be filed for purposes of Section
18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability
of that section, nor shall such exhibit be deemed to be incorporated by reference in any
registration statement or other document filed under the Securities Act of 1933, as amended,
or the Securities Exchange Act, except as otherwise stated in such filing. |
|
(1) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 1998. |
|
(2) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 2000. |
|
(3) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on June 4, 2001. |
|
(4) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on January 8, 2002. |
|
(5) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on January 23, 2003. |
|
(6) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on December 12, 2007. |
|
(7) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on September 28, 2005. |
|
(8) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 1996. |
|
(9) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Registration
Statement on Form S-8 (No. 333-98321), filed on August 19, 2002. |
|
(10) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 2004. |
|
(11) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Registration
Statement on Form S-8 (No. 333-71936), filed on October 19, 2001, as amended. |
|
(12) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Annual Report on
Form 10-K, as amended, for the year ended December 31, 2005. |
|
(13) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on June 7, 2006. |
|
(14) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended September 30, 2000. |
|
(15) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended September 30, 2007. |
|
(16) |
|
Incorporated by reference to the indicated exhibit in
Nektar Therapeutics Annual Report on Form 10-K for the year ended December 31, 2007. |
|
(17) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K/A, filed on March 16, 2006. |
|
(18) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended September 30, 2006. |
|
(19) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on November 21, 2008. |
|
(20) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Current Report on
Form 8-K, filed on January 2, 2009. |
|
(21) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended June 30, 2006. |
|
(22) |
|
Incorporated by reference to the indicated exhibit in Nektar Therapeutics Quarterly Report
on Form 10-Q for the quarter ended March 31, 2008. |
|
(23) |
|
Filed herewith. |
96
Filed by Bowne Pure Compliance
Exhibit 2.1
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
EXECUTION COPY
ASSET PURCHASE AGREEMENT
Dated as of October 20, 2008
By and Between
NEKTAR THERAPEUTICS (the Company),
AEROGEN, INC. (the Transferring Subsidiary),
NOVARTIS PHARMACEUTICALS CORPORATION (the Buyer)
and
NOVARTIS PHARMA AG (the Intangibles Purchaser)
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
ASSET PURCHASE AGREEMENT
This ASSET PURCHASE AGREEMENT is dated as of October 20, 2008 (this Agreement), by
and among (i) Novartis Pharmaceuticals Corporation, a Delaware corporation (the Buyer),
(ii) Novartis Pharma AG, a corporation organized under the laws of Switzerland, and an Affiliate of
the Buyer (the Intangibles Purchaser), (iii) Nektar Therapeutics, a Delaware corporation
(the Company), and (iv) AeroGen, Inc., a Delaware corporation and a direct Subsidiary of
the Company (the Transferring Subsidiary).
RECITALS
WHEREAS, the Company Parties are engaged in the research and development of technology arising
out of the business unit commonly referred to as pulmonary by the Company, including the
formulation, filling, manufacturing and device capabilities of such unit (the Business);
and
WHEREAS, upon the terms and conditions set forth herein, the Buyer and the Intangibles
Purchaser desire to purchase, and the Company and the Transferring Subsidiary desire to sell to the
Buyer and the Intangibles Purchaser, [***] the Business as set forth herein, including the Business
Intellectual Property (as defined below) (the Acquisition);
NOW, THEREFORE, in consideration of the foregoing and the respective representations,
warranties, covenants and agreements set forth herein, and intending to be legally bound hereby,
the parties hereto agree as follows:
ARTICLE I
DEFINITIONS
1.1 Defined Terms. Defined terms used in this Agreement have the meanings ascribed to
them as follows:
Affiliate shall mean, with respect to any Person, any other Person that directly or
indirectly, through one or more intermediaries, controls, is controlled by, or is under common
control with, such Person. When used in this Agreement, control (including, with correlative
meanings, the terms controlling, controlled by and under common control with), as used with
respect to any Person, shall mean the possession, directly or indirectly, of a majority of the
equity interests or the power to elect a majority of the board of directors (or Persons performing
similar functions) of such Person, whether through the ownership of voting securities, status as a
general partner, by contract or otherwise.
Board of Directors shall mean the board of directors of the Company.
Business shall have the meaning set forth in the Recitals, and, for the avoidance of
doubt, is intended to define the scope of assets being purchased and sold hereunder, subject to the
terms and conditions hereof, not the purposes for which such assets may be used.
2
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
Business Day shall mean any day other than (i) a Saturday or Sunday, (ii) a day on
which banks in New York, New York are required or authorized by law, executive order or
governmental decree to be closed or (iii) a public holiday in the cantons of Basel-Landschaft and
Basel-Stadt, Switzerland.
Business Employees shall mean the employees of the Business set forth in
Schedule 1.1(a) attached hereto.
Business Intellectual Property shall mean any or all Intellectual Property Rights
that are owned by or licensed to the Company Parties, in each case which are used, held for use in,
intended for use in, developed by or that arise or have arisen out of, or necessary for the
operation of the Business other than SEDS Intellectual Property and the Intellectual Property
Rights on Schedule 1.1(f).
Business Records shall mean all books and records, including all books of account,
ledgers, financial, accounting, scientific (including laboratory notebooks and invention
disclosures) records and files, personnel records and files of the Transferred Employees, manuals,
supplier lists and correspondence (in all cases in any form or medium) used, held for use or
intended for use in the Business or arising from or necessary for the operation of the Business and
such other books and records that otherwise relate primarily to the Business; provided,
however, that, in each case, the Company may exclude (i) those personnel-related books and
records that are prohibited by applicable Law from being transferred to the Buyer, (ii) those books
and records related solely to the Retained Assets [***] and (iii) the Corporate Records.
Buyer Service Agreement shall mean that certain Service Agreement, to be dated as of
the Closing Date, by and between the Company, the Transferring Subsidiary and the Buyer, in the
form attached hereto as Exhibit A or otherwise mutually agreed by the Company and the
Buyer.
Code shall mean the Internal Revenue Code of 1986, as amended.
Combination DMF shall have the meaning set forth in the Exclusive License Agreement.
Company Disclosure Schedule shall mean the Companys disclosure schedule delivered
by the Company to the Buyer immediately prior to the execution of this Agreement and attached
hereto and made a part hereof.
Company Parties shall mean the Company, the Transferring Subsidiary and the other
direct and indirect Subsidiaries of the Company.
Confidentiality Agreement shall mean the Confidential Disclosure Agreement effective
as of May 26, 2008, by and between the Company and Novartis Pharma AG.
3
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
Contracts shall mean all binding contractual arrangements, as amended from time to
time (subject to Section 5.2 of this Agreement), to which any Company Party is a party or
by which any of them is bound that are used, held for use or intended for use in, or that arise out
of, the Business, and such other binding contractual arrangements that otherwise relate primarily
to the Business.
dollars or $ shall mean United States dollars.
[***] means [***].
Environmental Laws shall mean all Laws or Orders applicable to the Business or
Transferred Assets relating to (i) pollution, contamination, restoration or protection of the
environment, health or safety or natural resources or (ii) the handling, use, presence, disposal,
release or threatened release of any Hazardous Substance.
Environmental Reports shall mean the documents set forth in Schedule 1.1(b)
attached hereto.
ERISA shall mean the Employee Retirement Income Security Act of 1974, as amended,
and the rules and regulations promulgated thereunder.
Exchange Act shall mean the Securities Exchange Act of 1934, as amended, and the
rules and regulations promulgated thereunder.
Excluded Taxes shall mean (i) all Taxes imposed on or payable by, or due to any
Governmental Authority from, any Company Party other than (x) the [***] of California sales Taxes
that the Buyer has agreed to pay pursuant to Section 6.4 hereof, and (y) Taxes relating to
the Business or to the Transferred Assets that are attributable to, or payable for, any
Post-Closing Period; and (ii) all Taxes relating to the Business or Transferred Assets that are
attributable to, or payable for, any Pre-Closing Period.
Exclusive License Agreement shall mean that certain Exclusive License Agreement, to
be dated as of the Closing Date, by and between the Company and the Intangibles Purchaser, in the
form attached hereto as Exhibit B or otherwise mutually agreed by the Company and the
Intangibles Purchaser.
FDA means the United States Food and Drug Administration, or any successor agency
thereto.
GAAP shall mean United States generally accepted accounting principles.
Governmental Authority shall mean any federal, state, municipal, foreign or other
governmental body, department, commission, board, bureau, agency, court or instrumentality,
domestic or foreign, or other entity exercising any executive, legislative, judicial,
quasi-judicial, tax, regulatory or administrative function of government, including the FDA and all
foreign equivalents thereof.
4
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
Hazardous Substance shall mean any substance that is (i) listed, classified or
regulated pursuant to any Environmental Law, (ii) any petroleum or petroleum product or by-product,
asbestos-containing material, lead-containing paint or plumbing, polychlorinated biphenyls,
radioactive materials or radon or (iii) any other substance which may be the subject of regulatory
action by any Governmental Authority pursuant to any Environmental Law.
HSR Act shall mean the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as
amended.
Independent Accounting Firm shall mean KPMG LLP or, if KPMG is unable to provide
services as contemplated herein, such other independent accounting firm as the parties mutually
agree.
Intellectual Property Rights shall mean any and all rights in, arising out of or
associated with (a) all United States, international and foreign patents and applications therefor
and all reissues, divisions, renewals, extensions, provisionals, continuations and
continuations-in-part thereof; (b) all Know-How; (c) all copyrights, copyright registrations and
applications therefor, and all other rights corresponding thereto throughout the world; (d) all
industrial designs and any registration and applications therefor throughout the world; (e) all
trade names, brand names, model names and other source indicators, logos, domain names, URLs,
common law trademarks and service marks, including all good will associated therewith, and all
registration and applications therefor throughout the world; (f) all mask works and all
applications, registrations, and renewals in connection therewith; and (g) all databases and data
collections and all rights therein throughout the world.
Inventory shall mean all of the Company Parties inventory and raw materials,
work-in-process, finished products, supplies, biological and chemical materials, accessories,
packaging materials, goods or parts used, held for use, held for sale or intended for use or sale
in, or to be furnished in relation to the Business, or such other inventory that otherwise relates
primarily to the Business.
Know-How shall mean ideas, inventions, discoveries, concepts, formulas, practices,
procedures, processes, methods, knowledge, know-how, trade secrets, technology, designs, drawings,
computer programs, skill, experience, documents, apparatus, results, clinical and regulatory
strategies, test data, including pharmacological, toxicological and clinical data, analytical and
quality control data, manufacturing data and descriptions, patents and legal data, market data,
financial data or descriptions, devices, assays, chemical formulations, results of experiments,
notes of experiments, specifications, compositions of matter, product samples and other samples,
physical, chemical and biological materials and compounds, and the like, whether in intangible,
tangible, written, electronic or other form.
Knowledge of the Company and similar phrases shall mean, with respect to any matter
in question, the actual knowledge after due inquiry and investigation of the Persons listed in
Schedule 1.1(c) attached hereto as would be reasonably expected for each such Person in
such role.
Law shall mean any federal, state, local or foreign law, statute, common law, rule,
regulation, code, directive, ordinance or other requirement of general application of any
Governmental Authority, including Environmental Laws.
5
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
Lease shall mean that certain Sublease and Lease Agreement dated as of October 2,
1996, by and between TMT Associates, LLC (the Landlord) and the Company, as amended by
that certain (i) First Amendment to Sublease and Lease Agreement dated as of October 30, 1996, by
and between the Landlord and the Company, (ii) Letter Agreement dated as of April 9, 1997, by and
between the Landlord and the Company, (iii) Third Amendment to Sublease and Lease Agreement dated
as of April 16, 1997, by and between the Landlord and the Company, and (iv) Fourth Amendment to
Sublease and Lease Agreement dated as of November 5, 1997, by and between the Landlord and the
Company.
Liabilities shall mean any direct or indirect liability, indebtedness, claim, loss,
damage, deficiency, Tax, obligation or responsibility, fixed or unfixed, liquidated or
unliquidated, secured or unsecured, accrued, absolute or contingent.
Licenses and Permits shall mean all licenses, permits, concessions, exemptions,
consents, franchises, certificates, DMFs (as defined in the Exclusive License Agreement),
variances, approvals, filings and other authorizations that are required by Governmental
Authorities under any applicable Law for the Company Parties to operate the Business as presently
conducted and to own or use the other Transferred Assets.
Lien shall mean any lien, claim, charge, option, mortgage, pledge or security
interest, rights of first refusal or rights of first offer, encumbrance (including leases,
easements, licenses, zoning ordinances, covenants, conditions, restrictions and rights-of-way) or
other similar right affecting real or personal property, in each case, whether arising by contract,
operation of law or otherwise.
[***] means [***].
Losses of any Person shall mean any and all demands, claims, suits, actions, causes
of action, proceedings, assessments, losses, damages, Liabilities, Taxes, costs and expenses
incurred by such Person, including settlement costs, costs of collection, interest, penalties and
customary attorneys fees, third-party expert and consultant fees and expenses, fines, judgments
and awards.
Material Adverse Effect shall mean any event, change, circumstance or effect that is
materially adverse to the financial condition, properties, assets, business, liabilities or results
of operations of the Transferred Assets or the Business or the ability of the Company or the
Transferring Subsidiary to consummate the transactions contemplated hereunder on a timely basis;
provided, however, that a Material Adverse Effect shall not include (i) changes,
effects and circumstances in connection with factors generally affecting the device and
pharmaceutical industries, but which do not have a disproportionate impact on the Transferred
Assets or the Business; or (ii) compliance by any party hereto with their respective express
obligations pursuant to the terms and conditions of this Agreement.
Nektar UK shall mean Nektar Therapeutics UK Limited, a limited liability company
formed under the laws of England and Wales.
[***] shall mean [***].
6
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
Option Agreement shall mean that certain Option Agreement dated as of October 2,
1996, by and between the Company and T.M.T. Associates, LLC.
Order shall mean any order, writ, injunction, judgment, decree or ruling entered,
issued, made or rendered by any court, administrative agency, arbitration tribunal or other
Governmental Authority of competent jurisdiction.
Permitted Liens shall mean (i) mechanics, carriers, workers or repairmens Liens
arising in the ordinary course of business and securing payments or obligations that are not
delinquent; (ii) Liens for Taxes, assessments and other similar governmental charges which are not
due and payable; (iii) Liens that arise under zoning, land use and other similar Laws and other
imperfections of title or encumbrances, if any, which do not materially affect the marketability of
the property subject thereto and do not materially impair the use of the property subject thereto
as used as of the date hereof; (iv) Liens that arise under leasing arrangements relating to
equipment or other personal property transferred to the Buyer or the Intangibles Purchaser pursuant
to this Agreement and set forth in Schedule 1.1(e) attached hereto; (v) licenses that arise
under the agreements set forth in Schedules 4.1(q)(iv) or (q)(v); and (vi) other
Liens set forth in Schedule 1.1(e) attached hereto.
Person shall mean any individual, corporation, partnership, firm, limited liability
company, joint venture, association, joint stock company, trust, unincorporated organization,
Governmental Authority or other entity.
Post-Closing Period shall mean (i) any taxable period that begins after the Closing
Date and (ii) the portion of a Straddle Period that begins after the Closing Date.
Pre-Closing Period shall mean (i) any taxable period that ends on or before the
Closing Date and (ii) the portion of a Straddle Period that ends on the Closing Date.
Proceeding shall mean any action, suit, dispute, litigation, hearing, claim,
grievance, arbitral action or other proceeding before any Governmental Authority, at law or in
equity.
Registered Intellectual Property shall mean those United States, international and
foreign: (a) patents and patent applications (including provisional applications); (b) registered
trademarks, registered service marks, registered tradenames, applications to register trademarks,
service marks or tradenames, intent-to-use applications, or other registrations or applications
related to trademarks or service marks; (c) registered copyrights and applications for copyright
registration; and (d) registered domain names and applications for domain name registrations, in
each case that are owned by the Company Parties as part of the Business Intellectual Property.
Representative shall mean any attorney, accountant, financial advisor or other
authorized representative of any Person.
Retained Intellectual Property shall mean the Intellectual Property Rights that are
owned by or licensed to the Company or the Transferring Subsidiary that do not constitute Business
Intellectual Property.
7
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
SEC shall mean the United States Securities and Exchange Commission.
Securities Act shall mean the Securities Act of 1933, as amended, and the rules and
regulations promulgated thereunder.
SEDS Intellectual Property shall mean those certain Intellectual Property Rights
held by any Company Party relating solely to SEDS Technology and not to any other Business
Intellectual Property. Notwithstanding anything to the contrary in this Agreement but subject to
Section 5.15 of this Agreement, the representations or warranties of any Company Party set forth in
this Agreement, any Transaction Document or any certificate executed by any Company Party for the
benefit of the Buyer or the Intangibles Purchaser delivered in connection herewith apply to any of
the SEDS Intellectual Property.
SEDS Technology shall mean [***].
Service Agreements shall mean the Buyer Service Agreement and the Transition
Services Agreement.
Specified Equipment shall mean the tangible personal property set forth in
Schedule 2.1(a)(iii), and the spray dryers and filler heads set forth in
Schedule 1.1(g) attached hereto whether or not located at the Transferred Real Property.
Stamford Notes shall mean that certain $7,000,000 Vendor Loan Note (6.7% per annum)
and those certain 662,727 (Euros) in loan notes payable by Stamford Devices Limited to the
Company.
Straddle Period shall mean any taxable period that begins on or before, and ends
after, the Closing Date.
Subsidiary and Subsidiaries when used with respect to any Person shall
mean any Person in which such Person directly or indirectly owns fifty percent (50%) or more of the
aggregate equity interests of such Person, whether voting or non-voting, or controls the ability to
appoint, remove or replace a general partner, fifty percent (50%) or more of the board of directors
or Persons conducting a similar function.
[***] shall mean [***].
Tax or Taxes shall mean (i) any taxes of any kind, including those
measured on, measured by or referred to as, income, alternative or add-on minimum, gross receipts,
escheat,
capital, capital gains, sales, use, ad valorem, franchise, profits, license, privilege,
transfer, withholding, payroll, employment, social, excise, severance, stamp, occupation, premium,
value added, property, environmental or windfall profits taxes, customs, duties or similar fees,
assessments or charges of any kind whatsoever, together with any interest and any penalties,
additions to tax or additional amounts (including any interest thereon) imposed by any Governmental
Authority and (ii) any liability for the payment of any amount of the type described in clause (i)
above as a result of a Person (A) being a transferee (within the meaning of Section 6091 of the
Code or any other applicable Law) of another Person, (B) being a member of an affiliated, combined
or consolidated group, (C) being disregarded as an entity separate from its owner (under Treasury
Regulations Section 301.7701-2(c)(2)(i) or similar provision of state, local or non U.S. law), or
(D) being subject to a contractual or other arrangement.
8
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
Tax Proceeding shall mean any pending or threatened Tax audit, assessment,
examination, investigation or administrative or court proceeding.
Tax Returns shall mean all reports, estimates, declarations of estimated Tax, claims
for refund, information statements and returns relating to, or required to be filed in connection
with, any Taxes, including any schedule or attachment thereto, and including any amendment thereof.
TIP Termination Agreement shall mean that certain Termination Agreement, to be dated
as of the Closing Date, by and between the Company and Novartis Vaccines and Diagnostics, Inc., in
the form attached hereto as Exhibit C or otherwise mutually agreed by the Company and the
Buyer.
Transaction Documents shall mean the Exclusive License Agreement, the Service
Agreements and the TIP Termination Agreement.
Transfer Taxes shall mean all sales, use, value added, documentary, stamp, gross
receipts, registration, transfer, conveyance, excise, recording, license, stock transfer stamps and
other similar Taxes and fees arising out of or in connection with or attributable to the
transactions effected pursuant to this Agreement.
Transferred Real Property shall mean the real property subject to the Lease.
Transition Services Agreement shall mean that certain Transition Services Agreement,
to be dated as of the Closing Date, by and between the Company and the Buyer, in the form attached
hereto as Exhibit D or otherwise mutually agreed by the Company and the Buyer.
1.2 Other Defined Terms. The following capitalized terms are defined in this
Agreement in the Section indicated below:
|
|
|
Defined Term |
|
Section |
401(k) Plan |
|
5.7(c) |
1060 Forms |
|
3.2(a) |
Acquisition |
|
Recitals |
Acquisition Proposal |
|
5.3 |
Adjustment |
|
2.5(c) |
Agreement |
|
Preamble |
Applicable Period |
|
5.3 |
ARC |
|
5.5(b) |
Assignment and Assumption Agreement |
|
8.2(d) |
Assumed Liabilities |
|
2.2(a) |
[***] |
|
[***] |
Building |
|
4.1(e) |
Business |
|
Recitals |
Buyer |
|
Preamble |
Buyers 401(k) Plan |
|
5.7(c) |
[***] |
|
[***] |
9
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
|
|
|
Defined Term |
|
Section |
CIP Royalties |
|
2.1(b)(vii) |
Closing |
|
7.1 |
Closing Date |
|
7.1 |
COBRA |
|
5.7(h) |
Company |
|
Preamble |
Company Plan |
|
4.1(k)(i) |
Consents |
|
2.4(a) |
Corporate Records |
|
2.1(b)(v) |
Direct Claim |
|
10.4(b) |
DOJ |
|
5.5(b) |
ERISA Affiliate |
|
4.1(k)(iii) |
Excluded Contracts |
|
2.1(b)(xii) |
FTC |
|
5.5(b) |
GFCO |
|
5.5(b) |
Identified Employee |
|
5.7(a) |
indemnified party |
|
10.3 |
indemnifying party |
|
10.3 |
Intangibles Purchaser |
|
Preamble |
Material Contracts |
|
4.1(p)(2) |
Nonassignable Asset |
|
2.4 |
Option |
|
4.1(e) |
Pearl |
|
2.1(a)(ix) |
Purchase Price |
|
3.1 |
Related Person |
|
4.1(o) |
Retained Assets |
|
2.1(b) |
Retained Liabilities |
|
2.2(b) |
[***] |
|
[***] |
SEDS Contracts |
|
4.1(q)(x) |
SEDS Option Period |
|
5.15(a) |
SEDS Notice |
|
5.15(a) |
Seller Parties |
|
5.1(c) |
Severance Costs |
|
5.7(a) |
Stamford |
|
2.1(a)(ix) |
Termination Date |
|
9.1(b) |
Third Party Claim |
|
10.4(a) |
[***] |
|
[***] |
Transfer Costs |
|
2.2(b)(v) |
Transferred 201 Assets |
|
2.1(a)(iii) |
Transferred Assets |
|
2.1(a) |
Transferred Licenses |
|
2.1(a)(v) |
Transferred Employees |
|
5.7(a) |
Transferred Share Agreements |
|
2.1(a)(ix) |
Transferred Shares |
|
2.1(a)(ix) |
Transferring Subsidiary |
|
Preamble |
Violation |
|
4.1(c) |
WARN |
|
5.2(a)(xi) |
10
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
1.3 Rules of Construction. References in this Agreement to gender include references
to all genders, and references to the singular include references to the plural and vice versa.
The words include, includes and including when used in this Agreement shall be deemed to be
followed by the phrase without limitation. The words to the extent when used in this Agreement
shall be deemed to be followed by the phrase and only to the extent. Unless the context
otherwise requires, references in this Agreement to Articles, Sections, Exhibits and Schedules
shall be deemed references to Articles and Sections of, and Exhibits and Schedules to, this
Agreement. Unless the context otherwise requires, the words hereof, hereby and herein and
words of similar meaning when used in this Agreement refer to this Agreement in its entirety and
not to any particular Article, Section or provision of this Agreement. The table of contents and
headings contained in this Agreement and the Company Disclosure Schedule are for reference purposes
only and shall not affect in any way the meaning or interpretation of this Agreement.
ARTICLE II
PURCHASE AND SALE OF THE TRANSFERRED ASSETS
2.1 Purchase and Sale of the Transferred Assets.
(a) Subject to the satisfaction or waiver of the conditions set forth in this Agreement, at
the Closing and as of the Closing Date, the Company or the Transferring Subsidiary shall (or shall
cause the other Company Parties to) sell, transfer, convey, assign and deliver to the Buyer or the
Intangibles Purchaser, and the Buyer or the Intangibles Purchaser shall purchase and acquire all
of the Company Parties right, title and interest in, to and under all of the assets (other than
the Retained Assets) used, held for use or intended for use in, or that arise out of, the
Business, and such other assets that otherwise relate primarily to the Business, including:
(i) the Inventory existing on the Closing Date;
(ii) the Company Parties owned or leased tangible personal property that is either located at
the Transferred Real Property or used, held for use or intended for use in, or that arises out of,
the Business, and such other tangible personal property that otherwise relates primarily to the
Business, including machinery, mobile and immobile equipment, the Specified Equipment, furniture,
office equipment, furnishings, transportation equipment, supplies and other tangible personal
property, and any warranties or guarantees, express or implied, existing for the benefit of the
Company Parties in respect to such tangible personal property;
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(iii) the Company Partys owned or leased tangible personal property located, as of the date
hereof or the Closing Date, at 201 Industrial Road in San Carlos, California and that is either set
forth in Schedule 2.1(a)(iii) attached hereto or used, held for use or intended for use in,
or that arises out of, the Business, and such other tangible personal property that otherwise
relates primarily to the Business, including machinery, mobile and immobile equipment, furniture,
office equipment, furnishings, transportation equipment, supplies and other tangible personal
property, and any warranties or guarantees, express or implied, existing for the benefit of the
Company Parties in respect to such tangible personal property (the Transferred 201
Assets);
(iv) each of the Contracts, including the Lease and the Option Agreement, but excluding the
Excluded Contracts;
(v) the Licenses and Permits, to the extent transferable, each of which is set forth in
Schedule 2.1(a)(v) attached hereto (the Transferred Licenses);
(vi) express or implied warranties, representations or guarantees, whether oral, written or
implied, made by suppliers of furnishing goods or services for the benefit of the Business to the
extent transferable;
(vii) the information systems, hardware, software systems, transferable software licenses and
database systems either (A) located at the Transferred Real Property, (B) located elsewhere but
that are used exclusively in relation to the Business or run on the servers set forth in
Schedule 2.1(a)(vii), and (C) the servers set forth in Schedule 2.1(a)(vii)
attached hereto but, in the case of (A) and (B), excluding Company-wide systems and other Retained
Assets;
(viii) the Business Intellectual Property;
(ix) subject to Schedule 3.1, the Stamford Notes, all of the shares of capital stock,
options to acquire capital stock and all other securities, if any, held by any Company Party (in
each case, including all accrued but unpaid dividends, interest or other rights) in each of
(A) Pearl Therapeutics, Inc., a Delaware corporation (Pearl), and (B) Stamford Devices
Limited, a company organized under the laws of the Republic of Ireland (Stamford)
(collectively, the Transferred Shares), including all agreements of the Company
and its Subsidiaries associated with the Transferred Shares set forth in
Schedule 2.1(a)(ix) attached hereto (the Transferred Share Agreements);
(x) copies of the Business Records which shall be shared and transferred pursuant to Section
5.12(a); and
(xi) copies of the portions of the Corporate Records that relate primarily to the Business.
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The properties, assets, rights and claims to be purchased by the Buyer or the Intangibles
Purchaser pursuant to this Section 2.1(a) shall collectively be referred to herein as the
Transferred Assets. As of the Closing, all right, title and interest to and risk of loss
as to the Transferred Assets (whether or not covered by insurance) shall pass from the applicable
Company Party to the Buyer or the Intangibles Purchaser free and clear of all Liens other than
Permitted Liens. As of the Closing, the Transferred Assets set forth in clauses (i), (ii), (iii),
(iv), (v), (vi), and(vii) of this Section 2.1(a) shall be purchased and acquired by the
Buyer and the Transferred Assets set forth in clauses (viii), (ix) and (x) of this
Section 2.1(a) shall be purchased and acquired by the Intangibles Purchaser.
(b) Notwithstanding anything to the contrary in Section 2.1(a) hereof, the Company
and the Transferring Subsidiary shall retain all of their respective existing right, title and
interest in, to and under, and the Transferred Assets shall exclude, the following assets
(collectively, the Retained Assets):
(i) all inventory owned or used by the Company Parties relating solely to the other Retained
Assets;
(ii) any Company Partys owned or leased tangible personal property located, as of the date
hereof, on the Transferred Real Property set forth in Schedule 2.1(b)(ii) attached hereto,
including any warranties or guarantees, express or implied, existing for the benefit of any Company
Party in respect to such tangible personal property;
(iii) all cash and cash equivalents;
(iv) all income Tax Returns, Tax refunds, Tax losses, Tax carryforwards, Tax credits and Tax
benefits of any Company Party;
(v) the books, records, files and minutes of meetings of the board of directors, committees or
shareholders, incorporation, stock transfer and Tax documents and all similar or related corporate
records of any Company Party (the Corporate Records) to the extent not relating to the
Business or not reasonably necessary for the reporting, operation, conduct or planning of the
Business;
(vi) all of the Company Parties right, title and interest under this Agreement and the
Transaction Documents;
(vii) [***] all right, title and interest to [***] (the CIP Royalties);
(viii) records pertaining to the Business Employees not constituting Transferred Employees;
(ix) the Company-wide information systems, telephone systems, the servers set forth in
Schedule 2.1(b)(x) attached hereto, and database systems and software systems that are run
on the servers set forth in Schedule 2.1(b)(x);
(x) the Companys Enterprise Resource Planning (ERP) system;
(xi) the Retained Intellectual Property;
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(xii) each of the contracts, agreements, and arrangements set forth in Schedule
2.1(b)(xiii) (the Excluded Contracts);
(xiii) subject to Section 5.15, the SEDS Intellectual Property and SEDS Contracts; and
(xiv) the Combination DMF.
2.2 Assumption of Liabilities.
(a) Subject to the satisfaction or waiver of the conditions set forth in this Agreement, at
the Closing and as of the Closing Date, the Buyer or the Intangibles Purchaser shall (or, subject
to Section 11.7 hereof, shall cause their respective Affiliates to) assume and agree to
pay, discharge or perform when due, only the Liabilities expressly set forth below:
(i) subject to Section 2.4 hereof, all Liabilities arising under the Contracts
relating to periods after the Closing, to the extent such Liabilities have not arisen as a result
of a default or breach of any such Contract by any Company Party;
(ii) all Liabilities related to the Transferred Employees (other than salary, wages, accrued
but unused paid time off, expense reimbursement payments, commissions and bonuses accrued prior to
the Closing) to the extent relating to periods after the Closing and, subject to
Sections 5.7 and 5.9, certain Liabilities related to the Transferred Employees
under WARN;
(iii) all Liabilities related to the Transferred Assets to the extent relating to periods
after the Closing, including arising out of Buyers or the Intangibles Purchasers use or ownership
of the Transferred Assets relating to periods after the Closing;
(iv) all Liabilities with respect to the Transferred Assets and the Transferred Real Property
arising pursuant to Environmental Laws to the extent relating to periods after the Closing;
(v) all Liabilities relating to any fees and expenses of the Buyer, the Intangibles Purchaser
or any of their Affiliates incurred in connection with this Agreement, the Acquisition or the
transactions contemplated hereby or thereby, including any fees or expenses of counsel to, or any
brokers, financial advisors or comparable other persons retained or employed by, the Buyer, the
Intangibles Purchaser or any of their Affiliates;
(vi) all Liabilities for Taxes arising out of the Business or the Transferred Assets to the
extent relating to periods after the Closing Date, and all liability for [***] of California sales
taxes that the Buyer has agreed to pay pursuant to Section 6.4 hereof;
(vii) all Liabilities for death, personal injury, other injury to persons or property damage
relating to, resulting from, caused by or arising out of, directly or indirectly, use after the
Closing Date of, or exposure after the Closing Date to, any of the Transferred Assets, or any part
or component thereof serviced, distributed, leased or sold after the Closing Date by or on behalf
of the Buyer, the Intangibles Purchaser or any of their Affiliates, including any such Liabilities
based on negligence, strict liability, product liability, design or manufacturing defect,
conspiracy, failure to warn or breach of express or implied warranties of merchantability or
fitness for any purpose or use, or any allegations concerning any of the foregoing;
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(viii) all Liabilities related to the Transferred Shares or the Transferred Share Agreements
to the extent relating to periods after the Closing; and
(ix) all Liabilities that the Buyer or the Intangibles Purchaser has expressly agreed to
retain, pay for or be responsible for pursuant to this Agreement.
The Liabilities assumed by the Buyer or the Intangibles Purchaser pursuant to this Section
2.2(a) shall collectively be referred to herein as the Assumed Liabilities.
(b) Except as otherwise expressly provided in this Agreement or any Transaction Document, the
Company and the Transferring Subsidiary shall retain all Liabilities other than the Assumed
Liabilities, including:
(i) all Liabilities related to or arising out of the Company Partys use or ownership of the
Retained Assets;
(ii) all Liabilities for Taxes relating to or arising out of the Transferred Assets or the
Business to the extent attributable to or relating to periods on or prior to the Closing Date and,
subject to Section 6.4, all Liabilities imposed on or payable by or due to any Governmental
Authority from any Company Party;
(iii) all Liabilities related to (A) the Transferred Employees to the extent relating to
periods on or prior to the Closing Date (including salary, wages, accrued but unused paid time off,
expense reimbursement payments, commissions, bonuses accrued prior to the Closing, severance
obligations, obligations related to stock options granted by the Company, other rights under any
Company Plan (as defined herein) or other rights of payment) and (B) all employees of the Company
who are not Transferred Employees;
(iv) all Liabilities relating to any fees and expenses of any Company Party incurred in
connection with this Agreement, the Acquisition or the transactions contemplated hereby or thereby,
including any fees or expenses of counsel to, or any brokers, financial advisors or comparable
other Persons, including J.P. Morgan Securities, Inc., retained or employed by, any Company Party;
(v) all transfer, assumption or assignment fees or expenses or other amounts or obligations
paid or incurred in connection with or by reason of assigning or transferring the Contracts or
other Transferred Assets and Assumed Liabilities to the Buyer or the Intangibles Purchaser (the
Transfer Costs);
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(vi) any termination fee payable by the Company, the Transferring Subsidiary, the Buyer, the
Intangibles Purchaser or any of their respective Affiliates under any Contract as a result of the
Acquisition or the other transactions to be consummated at the Closing, including any Contract not
transferable to the Buyer or the Intangibles Purchaser pursuant to the terms of such Contract or
assignable only upon the consent of the respective third party to such Contract and such third
party does not consent to the assignment to the Buyer or the Intangibles Purchaser of such Contract
pursuant to this Agreement;
(vii) all Liabilities with respect to the Transferred Assets and the Transferred Real Property
arising pursuant to Environmental Laws to the extent relating to periods prior to or at the
Closing;
(viii) subject to Section 2.4 hereof, all Liabilities arising under or related to (A)
the Contracts relating to periods prior to or at the Closing, or (B) the Excluded Contracts
regardless of time period;
(ix) all Liabilities related to the Transferred Assets to the extent relating to periods prior
to the Closing, including arising out of the Company Parties use or ownership of the Transferred
Assets relating to periods prior to or at the Closing;
(x) all Liabilities related to Permitted Liens to the extent arising prior to or at the
Closing;
(xi) all accounts payable of the Company Parties, including all accounts payable relating to
the Transferred Assets and the Business incurred by any Company Party prior to or at the Closing;
(xii) all Liabilities for death, personal injury, other injury to persons or property damage
relating to, resulting from, caused by or arising out of, directly or indirectly, use prior to or
on the Closing Date of, or exposure prior to or on the Closing Date to, any of the Transferred
Assets, or any part or component thereof serviced, distributed, leased or sold prior to or on the
Closing Date by or on behalf of any Company Party, including any such Liabilities based on
negligence, strict liability, product liability, design or manufacturing defect, conspiracy,
failure to warn or breach of express or implied warranties of merchantability or fitness for any
purpose or use, or any allegations concerning any of the foregoing;
(xiii) all Liabilities related to the Transferred Shares or the Transferred Share Agreements
to the extent related to periods prior to or at the Closing;
(xiv) all Liabilities that the Company or the Transferring Subsidiary has expressly agreed to
retain, pay for or be responsible for pursuant to this Agreement; and
(xv) all Liabilities related to the SEDS Contracts or the SEDS Intellectual Property.
The Liabilities retained by the Company and the Transferring Subsidiary pursuant to this
Section 2.2(b) are referred to herein as the Retained Liabilities.
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2.3 Transfer of Transferred Assets and Assumed Liabilities. The Transferred Assets
shall be sold, acquired, conveyed, transferred, assigned and delivered free and clear of all Liens
other than Permitted Liens, and the Assumed Liabilities shall be assumed, pursuant to transfer and
assumption agreements, notifications, or other instruments in such form, reasonably satisfactory to
the Company and the Buyer, as are necessary to effect a conveyance of the Transferred Assets and an
assumption of the Assumed Liabilities in the jurisdictions in which such transfers are to be made.
Such agreements and instruments, and such other conveyance and assumption documents as may be
required in such jurisdictions, shall be executed, upon the terms and subject to the conditions
hereof, on the Closing Date by the Company, the Transferring Subsidiary, the Buyer or the
Intangibles Purchaser, as applicable.
2.4 Procedures for Assets Not Transferable. (a) Notwithstanding anything to the
contrary contained in this Agreement and subject to Schedule 3.1, to the extent that the
sale, conveyance, transfer, assignment or delivery, or attempted sale, conveyance, transfer,
assignment or delivery, to the Buyer or the Intangibles Purchaser of any Transferred Asset (a
Nonassignable Asset) is prohibited by applicable Law or would require any governmental or
third-party authorizations, approvals, consents or waivers (collectively, the Consents),
and such Consent is not required to be delivered pursuant to Section 8.2(i) hereof, if any
such Consent shall not have been obtained prior to the Closing, this Agreement shall not constitute
a sale, conveyance, transfer, assignment or delivery thereof if any of the foregoing would
constitute a breach of applicable Law or the rights of any third party; provided,
however, that, notwithstanding the foregoing, subject to Article VIII hereof, the
Closing shall occur on the terms and conditions set forth herein, including the Companys right to
receipt of the Purchase Price in full at the Closing pursuant to Section 3.1 hereof;
provided, further, that the Company and the Transferring Subsidiary shall not be
relieved of their obligations to sell, and the Buyer and the Intangibles Purchaser shall not be
relieved of their obligations to purchase, acquire and assume, any such Nonassignable Asset.
Following the Closing, the Company shall use its reasonable best efforts, and the Buyer shall
cooperate with the Company, to obtain promptly such Consents. If any such Consent is obtained
after the Closing, the Company or the Transferring Subsidiary, as applicable, shall convey,
transfer, assign and deliver the applicable Nonassignable Asset to the Buyer or the Intangibles
Purchaser. Pending receipt of any such Consent, the parties shall use their reasonable best
efforts to implement an alternative arrangement to permit the Buyer or the Intangibles Purchaser,
as the case may be, to realize,
receive and enjoy substantially similar rights and the full benefits of any such Nonassignable
Asset as if such impediment to assignment or transfer did not exist. To the extent such
Nonassignable Asset is a Contract and such Contract may not be assigned to the Buyer by reason of
the absence of any such Consent, then (i) the Company shall promptly pay over to the Buyer the
amount of all payments received by it, from time to time, in respect of the applicable
Nonassignable Assets, and (ii) the Buyer shall promptly reimburse (or the Company shall reduce any
amounts payable by it under clause (i) by) the amount of any expenses incurred by the Company in
the course of providing the benefits of such Nonassignable Assets in amounts consistent with
expenses incurred by the Company performing such services prior to the Closing.
(b) In the event any Specified Equipment is not transferred to the Buyer at Closing, the
Company and Transferring Subsidiary shall pay to Buyer (or reduce the Purchase Price hereunder) by
an amount equal to the replacement cost of such Specified Equipment that is not so transferred.
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2.5 Payments Post-Closing; Prorations.
(a) If, following the Closing Date, the Company, the Transferring Subsidiary or any of their
Affiliates receives any payment or other proceeds any portion of which constitutes a Transferred
Asset, the Company or the Transferring Subsidiary shall promptly remit to the Buyer the amount of
any such payment or proceeds to the extent such payment or proceeds constitute Transferred Assets.
Any such payment or proceeds received, and any remittance made pursuant to this Section
2.5(a), shall be treated as having been received and made by the relevant entity solely as an
agent for the Buyer.
(b) If, following the Closing Date, the Buyer, the Intangibles Purchaser or any of their
Affiliates receives any payment or other proceeds any portion of which constitutes a Retained
Asset, including the CIP Royalties, the Buyer or the Intangibles Purchaser shall promptly remit to
the Company the amount of any such payment or proceeds (net of Taxes on the Buyer or the
Intangibles Purchaser) to the extent such payment or proceeds constitute Retained Assets [***].
Any such payment or proceeds received, and any remittance made pursuant to this Section
2.5(b), shall be treated as having been received and made by the relevant entity solely as an
agent for the Company.
(c) Except as otherwise expressly provided in this Agreement or any Transaction Document,
including Section 2.2 hereof, expenses and costs (including business and license fees, utility
charges, property and equipment rentals, fees, sales and service charges, and similar items, but
not Taxes or other types of Liabilities) related to the Business or the Transferred Assets that
are periodically invoiced (whether in advance or arrears) and the period in any such invoice
includes the Closing Date, shall be prorated between the Buyer and the Company on the following
basis: (i) the Company shall be responsible for all such expenses and costs allocable to the
conduct of the Business or operation of the Transferred Assets for the period ending at midnight
on the Closing Date and (ii) the Buyer shall be responsible for all expenses and costs allocable
to the conduct of the Business or operation of the Transferred Assets after midnight on the
Closing Date (the Proration).
(d) In the case of any Straddle Period, the amount of any Taxes for the Pre-Closing Tax
Period shall (i) in the case of ad valorem or property Taxes, be deemed to be the amount of such
Taxes for the entire Straddle Period multiplied by a fraction, the numerator of which is the
number of calendar days during the Straddle Period ending on (and including) the Closing Date and
the denominator of which is the total number of calendar days in the Straddle Period, and (ii) in
the case of all other Taxes, be determined based on an interim closing of the books as of the
close of business on the Closing Date. The balance of any Taxes for the Straddle Period shall be
attributable to the Post-Closing Tax Period. In the event the Company has received prepayment on
any Contract that constitutes a Transferred Asset for services to be provided after the Closing
Date, such prepayment shall be credited to the account of the Buyer. In the event any Company
Party has prepaid any Taxes that constitute an Assumed Liability, such Taxes shall be reimbursed
by the Buyer to the Company.
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(e) The initial determination of the final amount of the Proration shall be made by the
Buyer. Upon such determination, but no more than ninety (90) days after the Closing Date or such
later date if an invoice is received after such date, the Buyer shall submit such determination to
the Company for approval. If the Company disagrees with the determination made by the Buyer of
the Proration, the Company shall give prompt notice thereof, but in no event later than thirty
(30) days after receipt of such determination, specifying in reasonable detail the nature and
extent of such disagreement, and the Buyer and the Company shall have a period of thirty (30) days
to resolve such disagreement. If the parties are unable to resolve such disagreement within such
thirty (30) day period, the matter shall be resolved following the procedures contemplated in
Section 3.2(b) hereof.
ARTICLE III
PURCHASE PRICE
3.1 Purchase Price. Subject to Schedule 3.1, the aggregate purchase price for
the Transferred Assets and the rights conveyed by the Company and the Transferring Subsidiary to
the Buyer and the Intangibles Purchaser pursuant to this Agreement shall be an amount equal to
$115,000,000 (ONE HUNDRED FIFTEEN MILLION DOLLARS) (the Purchase Price), payable, subject
to the terms and conditions hereof, in full in cash by the Buyer to the Company at the Closing by
wire transfer of immediately available funds to an account designated by the Company at least five
(5) Business Days prior to the Closing.
3.2 Allocation of Purchase Price.
(a) The parties hereto agree to allocate the Purchase Price (and any Liabilities assumed
hereunder or under the Exclusive License Agreement that are properly treated as purchase price) in
accordance with the rules under Section 1060 of the Code and the Treasury Regulations promulgated
thereunder. The parties agree to act in accordance with the computations and allocations as
determined pursuant to this Section 3.2 in any relevant Tax Returns or filings, including
any forms or reports required to be filed pursuant to Section 1060 of the Code, the Treasury
Regulations promulgated thereunder or any provisions of local, state
and foreign law (the 1060 Forms), and to cooperate in the preparation of any 1060
Forms and to file such 1060 Forms in the manner required by applicable Law. Notwithstanding the
foregoing, the parties agree to allocate the Purchase Price (and any Liabilities assumed hereunder
or under the Exclusive License Agreement that are properly treated as purchase price) in
accordance with Schedule 3.2(a) attached hereto. The Buyer shall prepare draft 1060 Forms
that are consistent with the foregoing within thirty (30) days of the Closing, which it shall
submit to the Company and the Transferring Subsidiary for their consent, which consent shall not
be unreasonably withheld or delayed.
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(b) Any issues with respect to the allocation referred to in Section 3.2(a) above
which have not been finally resolved within forty-five (45) days following the Closing shall be
referred to the Independent Accounting Firm, which shall, within twenty (20) days after such
submission or such longer period as the Independent Accounting Firm may reasonably require,
determine and report to the Buyer and the Company upon such remaining disputed items, and such
determination shall be final, binding and conclusive on the parties hereto. The fees and
disbursements of the Independent Accounting Firm shall be allocated between the Buyer and the
Intangibles Purchaser, on the one hand, and the Company and the Transferring Subsidiary, on the
other hand, in such manner that the Buyer and the Intangibles Purchaser shall be responsible for
that portion of the fees and expenses equal to such fees and expenses multiplied by a fraction,
the numerator of which is the aggregate dollar value of disputed items submitted to the
Independent Accounting Firm that are resolved against the Buyer and the Intangibles Purchaser (as
finally determined by the Independent Accounting Firm) and the denominator of which is the total
dollar value of the disputed items so submitted, and the Company and the Transferring Subsidiary
shall be responsible for the remainder of such fees and expenses.
ARTICLE IV
REPRESENTATIONS AND WARRANTIES
4.1 Representations and Warranties of the Company. Except as set forth in the Company
Disclosure Schedule, the Company and the Transferring Subsidiary hereby, jointly and severally,
represent and warrant to the Buyer and the Intangibles Purchaser as set forth in this Article
IV. Each disclosure set forth in the Company Disclosure Schedule shall be deemed disclosed for
purposes of, and shall qualify and be treated as an exception to, any section of this Agreement to
the extent disclosure in one specific section of the Company Disclosure Schedule is specifically
referred to in another specific section of the Company Disclosure Schedule or indicated by
appropriate cross-reference or where it is reasonably apparent from the face of the disclosure
(without any additional investigation or knowledge) that a reference in one specific section in the
Company Disclosure Schedule also relates to another specific section of the Company Disclosure
Schedule.
(a) Due Organization. Each of the Company and the Transferring Subsidiary is a
corporation duly organized, validly existing and, where applicable, in good standing under the
laws of the jurisdiction of its organization. Each Company Party (i) has all
requisite corporate power and authority to own, lease and operate all of its properties and
assets (including all of the Transferred Assets) and to carry on the Business and its other
businesses as they are now being conducted and (ii) is in good standing and is duly qualified to
do business in each jurisdiction in which the nature of the Business and its other businesses or
the ownership, leasing or operation of its properties (including all of the Transferred Assets)
makes such qualification necessary, except where the failure to so qualify or be in good standing
has not had and would not reasonably be expected to have, individually or in the aggregate, a
Material Adverse Effect. The copies of the certificate of incorporation and by-laws or similar
organizational documents of the Company and the Transferring Subsidiary, which were previously
made available to the Buyer, are true, complete and correct copies of such documents as in effect
on the date of this Agreement. The Company Parties include all entities that are presently
Affiliates of the Company. Neither the Company nor the Transferring Subsidiary holds any stock,
limited liability company interest, partnership interest or any other equity interest in any
Person other than the other Company Parties, Pearl and Stamford.
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(b) Authorization and Validity of Agreement. The Company and the Transferring
Subsidiary have all requisite corporate power and authority to enter into this Agreement and the
Transaction Documents to which each is, or is specified to be, a party and to consummate the
transactions contemplated hereby and thereby. The execution, delivery and performance by the
Company and the Transferring Subsidiary of this Agreement and the Transaction Documents and the
consummation by the Company and the Transferring Subsidiary of the transactions contemplated
hereby and thereby have been duly and validly authorized by all necessary corporate action and no
other corporate action or proceeding (including the approval of Company stockholders) on the part
of the Company or the Transferring Subsidiary is or will be necessary for the execution, delivery
and performance by the Company and the Transferring Subsidiary of this Agreement or the
Transaction Documents and the consummation by the Company and the Transferring Subsidiary of the
transactions contemplated hereby or thereby. This Agreement and the Transaction Documents to
which each is, or is specified to be, a party have been duly and validly executed and delivered by
the Company and the Transferring Subsidiary, as applicable, and, assuming the due authorization,
execution and delivery hereof and thereof by the Buyer and the Intangibles Purchaser party
thereto, constitute legal, valid and binding obligations of the Company and the Transferring
Subsidiary, enforceable against each of them in accordance with its terms, except as may be
limited by bankruptcy, insolvency, reorganization, moratorium or other Laws relating to or
affecting creditors rights generally and by general equity principles (whether considered in a
proceeding in equity or at law). The Board of Directors and the board of directors of the
Transferring Subsidiary, by resolutions duly adopted at a meeting duly called and held, has each
(i) determined that the Acquisition and the transactions contemplated by this Agreement and the
Transaction Documents are expedient and in the best interests of the Company, the Transferring
Subsidiary and their respective stockholders and declared the Acquisition and the transactions
contemplated by this Agreement and the Transaction Documents advisable and (ii) approved this
Agreement and the Transaction Documents and the transactions contemplated by this Agreement and
the Transaction Documents, including the Acquisition.
(c) No Conflict. The execution and delivery by the Company and the Transferring
Subsidiary of this Agreement does not, and the execution and delivery by the Company and the
Transferring Subsidiary of each Transaction Document to which it is or is specified to be a party
will not, and the consummation of the Acquisition and the other transactions contemplated hereby
and thereby and compliance by the Company and the Transferring Subsidiary with the terms hereof
and thereof will not, except as set forth in the exceptions to Section 4.1(d) hereof,
(i) conflict with, or result in any violation in any material respect of, or constitute in any
material respect a default (with or without notice or lapse of time or both) under, or give rise
to a right of termination, cancellation, acceleration or increase of any obligation or liability
or the loss of a material benefit under, or the creation of a Lien on any of the Transferred
Assets (any such conflict, violation, default, right of termination, cancellation or acceleration,
loss or creation, a Violation), (ii) result in a Violation pursuant to any provision of
the certificate of incorporation, bylaws or other governing documents of any Company Party,
(iii) result in any Violation in any material respect of any material contractual obligations
(including the Contracts) of any Company Party, including any contract constituting a Retained
Asset, or (iv) result in any Violation in any material respect of any Licenses and Permits, Order
or Law applicable to the Business or the Transferred Assets.
21
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
(d) Consents. No consent, approval, authorization, Order, Licenses and Permits, or
registration, declaration or filing with, or notice to, any Governmental Authority or of, with or
from any other Person, is required in connection with the execution and delivery of this Agreement
or any Transaction Document by the Company or the Transferring Subsidiary or the consummation by
the Company or the Transferring Subsidiary of the transactions contemplated hereby or thereby,
except for (i) the filing with the SEC of such reports and other materials under the Exchange Act
as may be required in connection with this Agreement and the Transaction Documents and the
transactions contemplated hereby and thereby, (ii) any such consent, approval, authorization,
Order, Licenses and Permits, registration, declaration, filing or notice required under the HSR
Act and ARC and (iii) consents, approvals, authorizations, Orders, Licenses and Permits,
registrations, declarations, filings or notices which are set forth in Schedule 4.1(d) or
are not material to the Transferred Assets and the Business.
(e) Transferred Real Property. The Company has furnished to the Buyer an accurate
and complete copy of each instrument comprising the Lease, together with accurate and complete
copies of each material notice or waiver delivered in connection with the Lease. The Company is
not in breach in any material respect or default under the Lease and, to the Knowledge of the
Company, no event has occurred which, with notice or lapse of time or both, would constitute a
breach in any material respect or default under the Lease. Neither the Company nor the
Transferring Subsidiary has received any written notice from the Landlord alleging that any breach
or default by any Company Party exists under the terms of the Lease. The Lease will continue to
be binding in accordance with its terms immediately following the Closing, except in the event the
Lease would no longer be binding as a result of actions that are taken by the Buyer, the
Intangibles Purchaser or any of their respective Affiliates, provided that the failure to satisfy
the condition specified in Section 8.2(i) shall not in any case be deemed to result from
the actions taken by the Buyer or any of its Affiliates other than if such failure results from a
breach by the Buyer of Section 5.5 hereof. Other than by the instruments
referred to in the definition of Lease, the Lease has not been amended or modified and no
material consent or waiver has been granted with respect to any of the terms thereof. The Company
has furnished to the Buyer an accurate and complete copy of the Option Agreement, pursuant to
which the Company has rights to an option (the Option) to purchase the building (the
Building) in which the premises subject to the Lease are located. The Company has not
exercised the Option, and the Option is, to the Knowledge of the Company, in full force and
effect. Other than by the instruments referred to in the definition of Option Agreement, the
Option Agreement has not been amended or modified and no material consent or waiver has been
granted with respect to any of the terms thereof. The Company has furnished to the Buyer a
complete and accurate copy of any non-disturbance agreement presently in effect between the
Company and the holder of any deed of trust encumbering the Building.
(f) Title; Sufficiency of the Assets.
(i) The Company or the Transferring Subsidiary has good, valid and marketable title, of record
and beneficially, to all of the Transferred Assets (the Transferred Assets) and at the
Closing will transfer and deliver to the Buyer or the Intangibles Purchaser legal and valid title
to the Transferred Assets, free and clear of all Liens other than Permitted Liens. All of the
machinery, equipment and other tangible assets included in the Transferred Assets are in good and
usable condition, ordinary wear and tear excepted, have been maintained in accordance with normal
industry practice and are otherwise suitable for the purposes for which they are presently used by
the Company and the Transferring Subsidiary.
22
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
(ii) Schedule 4.1(f)(ii) lists all of the Transferred Shares, the Stamford Notes and
the record owners thereof. The Transferred Shares are validly issued, fully paid and nonassessable
and constitute all of the securities held by any Company Party in Pearl and Stamford. Other than
the Transferred Share Agreements, there are no outstanding obligations, options, warrants or other
rights, agreements, arrangements or commitments of any kind held by the Company Parties relating to
any securities of Pearl or Stamford. Other than the Transferred Shares listed in Schedule
4.1(f)(ii), none of the Company Parties holds, directly or indirectly, any securities of any
entity engaged in the Business.
(iii) The Transferred Assets comprise all of the assets employed by the Company Parties in
connection with the Business, other than the Retained Assets. The Transferred Assets, the rights
of the Buyer and the Intangibles Purchaser under the Transaction Documents and the rights of the
Buyer and the Intangibles Purchaser under the Business Intellectual Property (subject to
Section 4.1(q)(vi) hereof) are sufficient for the Buyer and the Intangibles Purchaser to
operate the Business (other than the items in clauses 2.1(b)(iii), (iv), (v), (vii), (viii), (ix),
(x), (xi) and (xii)) immediately following the Closing in substantially the same manner as the
Business is presently conducted.
(g) Taxes. There are no Liens (other than Permitted Liens) for Taxes upon the
Transferred Assets. All Taxes related to the Transferred Assets, to the extent attributable to
the Pre-Closing Period, have been or shall be, when due, paid by the Company or the Transferring
Subsidiary. All Tax Returns required to have been filed by the Company Parties
have been timely filed (and were true, correct and complete in all material respects) and all
Taxes required to be paid (including any Taxes shown to be payable on such Tax Returns) by the
Company Parties have been paid. All Taxes which the Company Parties are required by Law to
withhold and collect on or prior to the Closing Date from the wages of employees (including sales
Taxes, withholding of Taxes from the wages of employees and withholding of Taxes on distribution
or payments made to non-U.S. entities) have been, or will have been, duly withheld, collected and
paid over, in each case, to the proper taxing authorities to the extent due and payable. To the
Knowledge of the Company, no written claim has ever been made by any Governmental Authority in any
jurisdiction where any of the Company Parties does not file Tax Returns, or pay and collect Taxes
in respect of a particular type of Tax imposed by that jurisdiction, that any of such entities is,
or may be, subject to an obligation to file Tax Returns, or pay or collect Taxes, in respect of
such Tax in that jurisdiction. None of the Company Parties has agreed to any extension or waiver
of the statute of limitations applicable to any Tax Return, or agreed to any extension of time
with respect to a Tax assessment or deficiency, which period (after giving effect to such
extension or waiver) has not yet expired. There are no ongoing or pending Tax audits of any
Company Party.
23
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
(h) Legal Proceedings. There are no, and since November 1, 2005 there have not been
any, material Proceedings pending or, to the Knowledge of the Company, threatened in writing
against, affecting or involving any of the Transferred Assets or arising out of the conduct of the
Business. Neither the Company nor the Transferring Subsidiary is, or since November 1, 2005 has
been, subject to any material Order affecting the Business or involving the Transferred Assets.
(i) Licenses and Permits; Compliance with Laws.
(i) Schedule 4.1(i) contains a complete and accurate list of all Licenses and Permits.
The Licenses and Permits (whether or not comprising Transferred Licenses) include all licenses,
permits, concessions, exemptions, consents, franchises, certificates, variances, approvals and
filings with Governmental Authorities necessary for the Company Parties to own, lease and operate
the Transferred Assets and to carry on the conduct of the Business as it is being conducted as of
the date hereof.
(ii) The Company or the Transferring Subsidiary owns or possesses, as of the date hereof, each
of the Licenses and Permits and has made (on a timely basis in all material respects) all required
filings, applications and registrations with Governmental Authorities required to be made by the
Company or the Transferred Subsidiary in relation to the Business and the Transferred Assets
(including all authorizations required by the regulations of the FDA and all foreign equivalents
thereof). All Licenses and Permits are in full force and effect and all Transferred Licenses shall
remain in full force and effect immediately after the Closing.
(iii) No loss of any License or Permit is pending in any Proceeding or, to the Knowledge of
the Company, has been threatened in writing by a Governmental Authority,
except for normal expirations in accordance with the terms thereof or applicable Law, and all
Transferred Licenses may be transferred to the Buyer or the Intangibles Purchaser.
(iv) The Company and the Transferring Subsidiary are, and for the past three (3) years have
been, in compliance in all material respects with (A) the terms and conditions of the Licenses and
Permits and (B) all Laws applicable to the ownership or use of the Transferred Assets or the
conduct of the Business as conducted by the Company or the Transferring Subsidiary at the
applicable time, and the Company has not received any written notice alleging facts which, if true,
would constitute a failure to comply with either (A) or (B) of this Section 4.1(i)(iv).
(v) The Company has filed with the FDA all material required notices, supplemental
applications and annual or other reports required to be filed by the Company Parties in connection
with the operation of the Transferred Assets or the conduct of the Business.
24
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
(j) Environmental Matters.
(i) The Company Parties have complied in all material respects with all Environmental Laws
applicable to the Business, Transferred Real Property and the Transferred Assets.
(ii) Except as set forth in the Environmental Reports and as would not reasonably be expected
to result in the Buyer and the Intangibles Purchaser incurring material Liabilities pursuant to
Environmental Laws, (i) the Company Parties have not contaminated the Transferred Real Property
with any Hazardous Substance and (ii) to the Knowledge of the Company, no other Person has
contaminated the Transferred Real Property with any Hazardous Substance.
(iii) None of the Company Parties have received any written notice, demand, letter, claim or
request for information indicating that any such Person may be in violation of or subject to
Liability under any Environmental Laws relating to the Transferred Real Property.
(iv) No Proceeding is pending or, to the Knowledge of the Company, threatened against any
Company Party with respect to the Business, the Transferred Real Property or the Transferred
Assets, or against the Business, the Transferred Real Property or the Transferred Assets, under any
applicable Environmental Laws, and none of the Company Parties has assumed by Contract or operation
of Law with respect to the Business, the Transferred Real Property or the Transferred Assets any
outstanding material Liability pursuant to any applicable Environmental Law.
(k) Employee Benefits.
(i) The term Company Plan includes (1) each employee benefit plan (within the
meaning of Section 3(3) of ERISA) and (2) any other material plan, contract, agreement, policy or
other arrangement providing for employment, severance, deferred
compensation, bonus, performance awards, change-in-control benefits, stock or stock-related
awards, fringe benefits, disability benefits, supplemental employment benefits, paid time off,
vacation benefits, if any, retirement benefits, profit-sharing, post-retirement benefits or other
employee benefits or remuneration of any kind, in each case entered into, maintained or contributed
to in respect of any Business Employees or with respect to which any Company Party has any material
Liability in respect of any Business Employees. Schedule 4.1(k)(i) contains a true and
complete list of each Company Plan under which any Business Employee has or may have any present or
future right to benefits with respect to his or her employment with the Company or the Transferring
Subsidiary. Each Company Plan is maintained by and in the name of the Company or the Transferring
Subsidiary.
(ii) With respect to each Company Plan, the Company has provided or made available to the
Buyer a current, accurate and complete copy (or, to the extent no such copy exists, an accurate
description) of (A) all plan documents (including all amendments thereto), (B) the most recent
summary plan description together with the summary or summaries of material modifications thereto,
if any, (C) the most recent Annual Report (Form 5500) for each plan for which such a report is
required and (D) the most recent Internal Revenue Service determination letter issued to any
Company Plan intended to be qualified under Section 401(a) of the Code.
25
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
(iii) No plan presently or ever in the past maintained, sponsored, contributed to or required
to be contributed to by the Company, the Transferring Subsidiary or any of their respective ERISA
Affiliates is or ever in the past was (i) a multiemployer plan as defined in Section 3(37) of
ERISA, (ii) a plan described in Section 413 of the Code, (iii) a plan subject to Title IV of ERISA,
Section 302 of ERISA, or Section 412 of the Code or (iv) a plan that provided health or other
non-pension benefits following an employees retirement. The term ERISA Affiliate means
any Person that, together with the Company or any of its Subsidiaries, would be deemed a single
employer within the meaning of Section 414(b), (c), (m) or (o) of the Code.
(iv) Each Company Plan has been maintained, administered and operated in material compliance
with the terms and applicable provisions of ERISA, the Code and other Applicable law. The Company
or the Transferring Subsidiary has received a favorable determination letter from the Internal
Revenue Service or that each Company Plan that is intended to meet the qualification requirements
of Section 401(a) of the Code has met such requirements and, to the Companys knowledge, nothing
has occurred since the date of such letter that could be expected to adversely affect such
qualified status.
(v) All Business Employees have been paid in full all wages, salaries, bonuses, commissions,
paid time off and severance for services performed up to the date hereof, and all contributions
required to be made to any Company Plan have been timely made.
(vi) The Transferred Employees do not participate in any employee benefit plan, program or
arrangement maintained or contributed to by the Company Parties outside of the United States.
(vii) With respect to any Company Plan that is a group health plan within the meaning of
Section 607 of ERISA and is subject to Section 4980B of the Code, the Company has complied in all
material respects with the continuation coverage requirements of the Code and ERISA with respect to
the Business Employees.
(l) Labor and Employment Matters.
(i) With respect to the Business Employees (a) there are no collective bargaining or other
labor union agreements presently in existence or being negotiated by the Company Parties to which
any of the Company Parties is or may become a party or by which any of them is or may become bound;
(b) no labor organization has been certified or recognized as the representative of any Business
Employees; (c) none of the Company Parties has encountered any labor union organizing activity or
had any employee strikes, material work stoppages, material slowdowns or lockouts; (d) there are no
unfair labor practice charges, administrative charges or complaints pending or, to the Knowledge of
the Company, threatened against the Company Parties; (e) there are no Proceedings pending or, to
the Knowledge of the Company, threatened in writing against the Company Parties by or with respect
to any of the Business Employees asserting violations of any laws respecting employment, including
provisions related to payment of wages, hours of work, equal opportunity, discrimination,
harassment, retaliation, occupational health and safety and employee privacy rights; and (f) the
Company Parties are in compliance in all material respects with all Laws respecting employment,
including provisions related to payment of wages, hours of work, equal opportunity, discrimination,
harassment, retaliation, citizenship and immigration, occupational health and safety, WARN and
employee privacy rights.
26
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
(ii) Schedule 4.1(l)(ii) sets forth a true, complete and accurate list of each
Business Employee, his or her date(s) of hire by the Company, position and title, if any, current
rate of compensation (including bonuses, commissions and incentive compensation, if any), and in
the case of each Business Employee, whether such employee is hourly or salaried, whether such
employee is exempt or non-exempt and whether such employee is absent from active employment and, if
so, the date such employee became inactive, the reason for such inactive status and, if applicable,
the anticipated date of return to active employment. All such Business Employees are employed by
the Company or the Transferring Subsidiary. The Company has delivered or made available to the
Buyer all written employee handbooks, policies, programs and arrangements with respect to the
Business Employees.
(iii) All Business Employees are employees at will or, subject to applicable employment Laws,
otherwise employed such that the Company may lawfully terminate their employment at any time, with
or without cause (in some cases subject to notice requirements and/or obligations to pay severance
or other termination payments), without creating severance obligations. A true and correct copy of
any form of non-compete, non-solicitation or confidentiality agreement presently in force with any
of the Business Employees has been delivered or made available to Buyer.
(iv) Neither the execution of this Agreement nor the consummation of the transactions
contemplated hereby shall cause the Company Parties to be in material breach of any material
contract with any Business Employee or cause the Company Parties to be liable to pay any material
severance or other material amount to any such employee.
(v) The Company reviewed all work permits, visas and other immigration documents relating to
any Transferred Employees, determining that they were in compliance with Applicable Laws.
(m) Brokers, Finders, etc. No agent, broker, investment banker, financial advisor or
other firm or Person is or will be entitled to any brokers or finders fee or any other similar
commission or fee in connection with any of the transactions contemplated by this Agreement,
except J.P. Morgan Securities, Inc., whose fees and expenses will be paid by the Company in
accordance with the Companys agreement with such advisor.
(n) Insurance. Schedule 4.1(n) contains a complete and accurate list of all
policies or binders of insurance presently maintained by the Company or the Transferring
Subsidiary that provide coverage with respect to the Transferred Assets or the conduct of the
Business, showing as to each policy or binder the carrier, policy number, expiration dates and a
general description of the type of coverage provided. All such policies are in full force and
effect, all premiums due and payable thereon have been paid and no written notice of cancellation
or termination has been received with respect to any such policy, which has not been replaced on
substantially similar terms prior to the date of such cancellation.
27
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
(o) Transactions with Related Persons. Other than employment related Contracts, the
Contracts do not include any agreements with any of the stockholders holding five (5) percent or
more of the outstanding common stock of the Company, directors, officers or employees of the
Company, the Transferring Subsidiary or any Affiliate thereof or any relative or spouse of any of
the foregoing Persons or any other Affiliate of the foregoing Persons (collectively, the
Related Persons).
(p) Material Contracts.
(i) Schedule 4.1(p) sets forth all of the Contracts, other than the SEDS Contracts:
(A) with respect to the employment or termination of, or severance or retirement
arrangements relating to, any Business Employees, excluding offer letters that confirm
at-will employment and ordinary course agreements to arbitrate, confidentiality agreements
and equity award agreements substantially in the Companys standard form;
(B) with respect to any bonus, retention, profit sharing, stock option, stock purchase,
phantom stock, pension, retirement, post-retirement, deferred compensation, employment or
other employee benefit plans, agreements, trusts, funds or other arrangements for the
benefit or welfare of any Business Employee, excluding offer letters that confirm at-will
employment and ordinary course agreements to arbitrate, confidentiality agreements and
equity award substantially in the Companys standard form;
(C) which is a material contract (as such term is defined in Item 601(b)(10) of
Regulation S-K of the SEC);
(D) which provides for any payment by or to the Company or the Transferring Subsidiary
in excess of [***] in any year or which is not terminable within one (1) year of that date
hereof without penalty;
(E) which provides for or requires any aggregate future payments in excess of [***]
with respect to, or in connection with, any capital expenditures or the acquisition or
construction of fixed assets;
(F) which contains any ongoing indemnification obligation by any of the Company Parties
which could reasonably be expected to require the payment by such entity in excess of [***]
in the aggregate;
(G) relating to, or evidencing, indebtedness for borrowed money or any guarantee of
indebtedness for borrowed money, in each case involving an amount in excess of [***] or
otherwise placing a Lien on any portion of the Business or Transferred Assets;
(H) to which any Governmental Authority is a party;
28
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
(I) the Contracts disclosed or required to be disclosed pursuant to Sections
4.1(q)(iv) or (v);
(J) with respect to any all joint venture, partnership or similar agreements or
arrangements;
(K) that limit or purport to limit the ability of the any of the Company Parties, or
would limit or purport to limit the ability of the Buyer, the Intangibles Purchaser or any
of their Affiliates, to compete in any line of business or with any Person or in any
geographic area or during any period of time and that relate to the Business or the
Transferred Assets;
(L) with respect to which (a) the provider thereunder is the sole source of the
respective goods or services or (b) the goods or services could not be reasonably obtained
from an alternate provider on commercially reasonable terms no less favorable to the Company
or the Buyer in any material respect than those set forth in relevant agreement; or
(M) is otherwise material to the conduct of the Business as presently conducted or with
respect to the Transferred Assets.
(ii) The Company has previously made available to the Buyer complete and accurate copies of
each Contract set forth in Schedule 4.1(p) (the Material Contracts). All of the
Material Contracts are valid and in full force and effect. Either of the Company or the
Transferring Subsidiary is party to each Material Contract and no Affiliate of the Company or the
Transferring Subsidiary is party thereto. Neither the Company nor the Transferring Subsidiary,
and, to the Knowledge of the Company, none of the other parties thereto, has violated in any
material respect, or committed or failed to perform any act which (with or without notice, lapse of
time or both) would constitute a material default under the provisions of, any Material Contract.
(q) Intellectual Property.
(i) Schedule 4.1(q)(i) lists all pending Proceedings before any Governmental Authority
(including the United States Patent and Trademark Office or equivalent
authority anywhere in the world) related to any Business Intellectual Property, but excluding
any such Proceedings in the normal course of prosecution of any pending trademark or patent
application included in the Registered Intellectual Property (including any office action, examiner
interview and the like). No Business Intellectual Property is the subject of any pending
Proceeding, Order or stipulation binding on any Company Party restricting in any material respect
the use, transfer or licensing thereof by such Company Party.
29
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
(ii) With respect to each item of material Registered Intellectual Property, necessary
registration, maintenance, annuities and renewal fees in connection with such Registered
Intellectual Property have been made in a timely manner and all necessary documents and
certificates in connection with such Registered Intellectual Property have been filed in a timely
manner with the relevant patent authorities in the United States and other countries of the world
for the purposes of maintaining such Registered Intellectual Property, except for any failure to
pay any fees or file any documents or certificates in a timely manner which has been made known to
Buyer and may be corrected before the date on which the applicable Registered Intellectual Property
could not be renewed or revived (as determined under applicable statute, rule or regulation).
(iii) All Registered Intellectual Property is listed in Schedule 4.1(q)(iii). The
Company or the Transferring Subsidiary, and not any other Company Party, owns and has good and
exclusive title, in each case free and clear of any Lien (other than Permitted Liens), to all
Business Intellectual Property.
(iv) Schedule 4.1(q)(iv) lists each agreement pursuant to which any Company Party has
received a license or similar rights to any Intellectual Property Rights owned by a third party
that constitutes Business Intellectual Property, but excluding shrink-wrap software agreements that
are generally commercially available or non-disclosure agreements that provide to any Company Party
no more than limited use for evaluation of trade secrets.
(v) Schedule 4.1(q)(v) lists each agreement pursuant to which any Company Party has
transferred ownership of, or granted any license or similar rights with respect to, any Business
Intellectual Property to any third party.
(vi) To the Knowledge of the Company, the Company or the Transferring Subsidiary owns or
possesses adequate licenses or rights to use, in each case free and clear of any Lien (other than
Permitted Liens) and subject to existing rights or obligations under any Contracts or Excluded
Contracts, all Business Intellectual Property, in the conduct of the Business as presently
conducted.
(vii) To the Knowledge of the Company, (A) no person has infringed or misappropriated or is
infringing or misappropriating any Business Intellectual Property and (B) neither the Company nor
the Transferring Subsidiary nor any of their respective Affiliates has infringed or misappropriated
or is infringing or misappropriating, in connection with the operation of the Transferred Assets or
the conduct of the Business as presently conducted, the Intellectual Property Rights of any third
party. No Company Party has received written notice that it infringes or misappropriates, or is
alleged to infringe or misappropriate, the Intellectual Property Rights of any third party in
connection with the operation of the Transferred Assets or the conduct of the Business as presently
conducted.
(viii) All employees, officers, contractors and consultants of the Company Parties employed or
providing technology-related services for the Business have executed agreements requiring
assignment to a Company Party of all inventions made during the course of and as a result of their
association with it as part of the Business and obligating the individual to maintain as
confidential the confidential information of the applicable Company Party that constitutes Business
Intellectual Property.
(ix) To the Knowledge of the Company, there are no conduct or matters which could reasonably
be expected to adversely affect the validity or the enforceability of any Business Intellectual
Property.
(x) Neither the SEDS Intellectual Property nor any contract, agreement or arrangement relating
thereto is necessary to conduct the Business as it is presently conducted.
30
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
(r) Financial Information.
(i) [***].
(ii) [***].
(s) No Material Adverse Effect. Since June 30, 2008, no event, occurrence or
circumstance has arisen that has had or could reasonably be expected to result in a Material
Adverse Effect.
(t) Absence of Changes or Events. Except as expressly contemplated by this Agreement
since June 30, 2008, neither the Company nor the Transferring Subsidiary, in relation to the
Transferred Assets or the Business, has:
(i) borrowed any amount or incurred or become subject to any Liabilities, other than (A)
Liabilities incurred in the ordinary course of business), (B) Liabilities under contracts entered
into in the ordinary course of business (provided such contracts are
disclosed pursuant to Section 4.1(p) hereof or are not required to be disclosed
thereunder) and (C) borrowings from banks (or similar financial institutions) necessary to meet
ordinary course working capital requirements);
(ii) mortgaged, pledged or subjected to any Liens (other than Permitted Liens) any portion of
the Transferred Assets;
(iii) amended the charter or bylaws (or similar organizational document) of the Company or the
Transferring Subsidiary;
(iv) sold, assigned, transferred or otherwise disposed of any Business Intellectual Property;
(v) adopted a plan or agreement of restructuring, merger, arrangement, consolidation,
recapitalization or other reorganization;
(vi) made any change to the methods of accounting, accounting practices, accounting policies,
or accounting procedures;
(vii) made any capital investment in, any loan to or any acquisition of the securities or
assets constituting a business of any other Person (other than an investment by the Company in a
wholly-owned Subsidiary);
(viii) entered into any employment contract with any Business Employee with base compensation
exceeding $50,000 per year or any collective bargaining agreement or other labor-related agreements
with any labor union, labor organization, employee association, employee bargaining agent or
affiliated bargaining agent, or modified the terms of any such existing contract or agreement;
31
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
(ix) made any other material change in employment terms (including compensation) for any
Business Employees having employment contracts with annual payments exceeding $50,000 per year; or
(x) entered into any contract or agreement, whether written or oral, to do any of the actions
referred to in Sections 4.1(t)(i) through (ix) above.
(u) Solvency. The Company is not now insolvent, and will not be rendered insolvent,
by consummating the Acquisition. As used in this section, insolvent means that the sum of the
debts and other probable Liabilities of the Company exceeds the present fair saleable value of the
Companys assets. Immediately after giving effect to the transactions contemplated by this
Agreement and the Transaction Documents (i) the Company will be able to pay its Liabilities as they become due in the normal course of its business; (ii) the
Company will not have unreasonably small capital with which to conduct its present or proposed
business; (iii) the Company will have assets (calculated at fair market value) that exceed its
Liabilities; and (iv) taking into account all pending and threatened litigation, final judgments
against the Company in actions for money damages are not reasonably anticipated to be rendered at
a time when, or in amounts such that, the Company will be unable to satisfy any such judgments
promptly in accordance with their terms (taking into account the maximum probable amount of such
judgments in any such actions and the earliest reasonable time at which such judgments might be
rendered) as well as all other obligations of the Company then due by the Company. Immediately
after giving effect to the transactions contemplated by this Agreement and the Transaction
Documents, the cash available to the Company, after taking into account all other expected uses of
such cash, will be sufficient to pay all such debts and judgments promptly in accordance with
their terms.
(v) Regulatory Status. The Company has not received any written notice that any
filings with any Governmental Authority in relation to the Business or the Transferred Assets are
not presently in good standing. The Company or, to the Knowledge of the Company, the applicable
third party has filed with the FDA all required notices, supplemental applications and annual or
other reports, which are material to the operation of the Business as presently conducted by the
Company. The Company has delivered to the Buyer copies of all (i) material reports of inspection
observations, (ii) material establishment inspection reports, (iii) material warning letters and
(iv) any other material documents received by the Company from the FDA or any other Governmental
Authority relating to the Business or Transferred Assets that assert ongoing material lack of
compliance with any Laws (including regulations promulgated by the FDA and any other Governmental
Authority) by the Company.
(w) Inventory. The Inventory of the Business consists of raw materials and supplies,
manufactured and purchased parts, goods in process and finished goods, all of which is
merchantable and fit for the purpose for which it was procured or manufactured, held in amounts as
required in the ordinary course of business.
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Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
4.2 Representations and Warranties of the Buyer. The Buyer and the Intangibles
Purchaser hereby, jointly and severally, represent and warrant to the Company and the Transferring
Subsidiary as set forth in this Section 4.2.
(a) Due Organization and Power. Each of the Buyer and the Intangibles Purchaser is a
corporation duly incorporated or otherwise organized, validly existing and in good standing under
the laws of its jurisdiction of incorporation or organization.
(b) Authorization and Validity of Agreement. The Buyer and the Intangibles Purchaser
have all requisite corporate power and authority to enter into this Agreement and the Transaction
Documents to which each is, or is specified to be, a party and to consummate the
transactions contemplated hereby and thereby. The execution, delivery and performance by the
Buyer and the Intangibles Purchaser of this Agreement and the Transaction Documents and the
consummation by the Buyer and the Intangibles Purchaser of the transactions contemplated hereby
and thereby have been duly and validly authorized by all necessary corporate action by the board
of directors of the Buyer and the Intangibles Purchaser and no other corporate action or
proceeding on the part of the Buyer or the Intangibles Purchaser is or will be necessary for the
execution, delivery and performance by the Buyer and the Intangibles Purchaser of this Agreement
or the Transaction Documents and the consummation by the Buyer and the Intangibles Purchaser of
the transactions contemplated hereby or thereby. This Agreement and the Transaction Documents to
which each is, or is specified to be, a party have been duly and validly executed and delivered by
the Buyer and the Intangibles Purchaser, as applicable, and, assuming the due authorization,
execution and delivery hereof by the Company and the Transferring Subsidiary party thereto,
constitute legal, valid and binding obligations of the Buyer and the Intangibles Purchaser,
enforceable against the Buyer and the Intangibles Purchaser in accordance with its terms, except
as may be limited by bankruptcy, insolvency, reorganization, moratorium or other Laws relating to
or affecting creditors rights generally and by general equity principles (whether considered in a
proceeding in equity or at law).
(c) No Conflict. The execution and delivery of this Agreement or any Transaction
Documents does not, and the Closing will not except as set forth in the exceptions to Section
4.2(d) hereof, (i) result in any violation of any provision of the articles or certificate of
incorporation, by-laws or similar organizational documents of the Buyer, the Intangibles Purchaser
or any of their Subsidiaries, (ii) conflict with any material loan or credit agreement, note,
bond, mortgage, guarantee, deed of trust, indenture or lease, to which the Buyer, the Intangibles
Purchaser or any of their Subsidiaries is a party or (iii) result in any violation of any license,
permit, concession, exemption, consent, franchise, certificate, variance, approval, Order or Law
applicable to the Buyer, the Intangibles Purchaser or any of their Subsidiaries or their
respective properties, rights or assets, except in the case of subclause (ii) or (iii) for any
such conflict or violation which would not materially adversely affect the ability of the Buyer or
the Intangibles Purchaser to perform its obligations under this Agreement.
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Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
(d) Consents. No consent, approval, authorization, Order, licenses, permits, or
registration, declaration or filing with, or notice to, any Governmental Authority or of, with or
from any other Person, is required in connection with the execution and delivery of this Agreement
or any Transaction Documents by the Buyer or the Intangibles Purchaser or the consummation by the
Buyer or the Intangibles Purchaser of the transactions contemplated hereby or thereby, except for
(i) the filing with the SEC of such reports and other materials under the Exchange Act as may be
required in connection with this Agreement and the transactions contemplated hereby (ii) any such
consent, approval, authorization, registration, declaration, filing or notice required under the
HSR Act and ARC and (iii) consents, approvals, authorizations or registrations which are set forth
in Schedule 4.2(d) or which would not materially adversely affect the ability of the Buyer
or the Intangibles Purchaser to perform its obligations under this Agreement.
(e) Brokers, Finders, etc. None of the Buyer, the Intangibles Purchaser nor any of
their Affiliates has employed any agent, broker, investment banker, financial advisor or other
firm or Person in connection with the transactions contemplated by this Agreement, who is entitled
to a fee or commission in connection with such transactions.
(f) Financing. The Buyer and the Intangibles Purchaser will have available to them,
at the Closing, immediately available funds necessary to pay the Purchase Price.
(g) Legal Proceedings. There are no Proceedings pending or threatened against or
affecting the Buyer, the Intangibles Purchaser or any of their Subsidiaries, or any of their
respective properties, assets or rights, and none of the Buyer, the Intangibles Purchaser nor any
of their Subsidiaries is subject to any Order which, in either case, would or seeks to enjoin,
rescind or materially delay the transactions contemplated by this Agreement or otherwise hinder
the Buyer or the Intangibles Purchaser from timely complying with the terms and provisions of this
Agreement.
(h) Investment Intent. The Buyer or the Intangibles Purchaser, as applicable, is
acquiring the Transferred Shares for investment and not with a view toward, or for sale in
connection with, any distribution thereof in violation of any applicable federal or state
securities Laws. The Buyer and the Intangibles Purchaser acknowledge that the Transferred Shares
have not been registered under the Securities Act or the securities or blue sky laws of any
state or province and that the Transferred Shares may not be sold, transferred, offered for sale,
pledged, hypothecated or otherwise disposed of without registration under the Securities Act,
except pursuant to an exemption from such registration available under the Securities Act, and
without compliance with state, provincial and foreign securities Laws, in each case to the extent
applicable.
(i) [***].
(i) [***].
(ii) No Fraud Waiver. Notwithstanding anything to the contrary set forth in this
Agreement, including this Section 4.2(j), in no event shall the Buyer, the Intangibles
Purchaser, the Company, the Transferring Subsidiary or any of their Affiliates waive hereby, or be
deemed to have waived hereby, any right, claim or cause of action that the Buyer, the Intangibles
Purchaser, the Company, the Transferring Subsidiary or any of their Affiliates may have or assert
against any other party hereto or any of its Affiliates relating to fraud, and the waivers in this
Agreement shall not be deemed to waive or absolve the Buyer, the Intangibles Purchaser, the
Company, the Transferring Subsidiary or any of their Affiliates from any Liability for fraud.
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Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
ARTICLE V
COVENANTS
5.1 Access; Information and Records.
(a) Subject to Section 5.10 hereof, from the date hereof to the earlier of the
Closing Date or the termination of this Agreement, upon reasonable prior written notice, the
Company shall afford the officers, employees, auditors and other Representatives of the Buyer
reasonable access, consistent with applicable Law, at all reasonable times, to officers,
employees, properties, offices, plants and other facilities of the Transferring Subsidiary or any
of its Subsidiaries and to all books and records of the Company Subsidiaries related to the
Transferred Assets or the Business and shall furnish the Buyer with all financial, operating and
other data and information as the Buyer, through its officers, employees, auditors or other
Representatives, may from time to time reasonably request in writing and any reports and other
documents filed by the Company Parties during such period with any Governmental Authority pursuant
to the requirements of applicable Law relating to the Transferred Assets or the Business.
(b) The Buyer and the Intangibles Purchaser agree that all communications by, or at the
direction of, the Buyer or the Intangibles Purchaser to any director, officer, employee or
Representative of any Company Party shall be coordinated through the Company, unless the Company
shall otherwise consent in writing, such consent not to be unreasonably withheld, conditioned or
delayed; provided, however, once initially coordinated by the Company, the Buyer,
the Intangibles Purchaser or their Affiliates shall be entitled to have direct communication and
contact with Business Employees with regard to the terms and conditions of employment by the
Buyer, the Intangibles Purchaser or their Affiliates.
(c) Within three days of the date hereof, the Company shall request from the Landlord consent
for the Buyer to conduct, or cause to be conducted, a Phase II environmental risk assessment for
soil and ground water at the Transferred Property (the Phase II). The Company shall use
commercially reasonable efforts to obtain such consent and enable the Phase II to be conducted
prior to Closing. The Phase II shall occur during normal business hours. The Buyer and its
Representatives shall be entitled to enter the Transferred Real Property to perform the Phase II
and any and all other reasonable inspections and tests reasonably required by the Buyer of the
Transferred Real Property; provided, however, that (i) any inspections or tests of
the Transferred Real Property leased or subleased by the Company or any of its Affiliates,
including the Phase II, shall be conducted only upon receipt by the Company and the Buyer of the
prior written consent of the owner of such Transferred Real Property, to the extent required by
Law or contract, (ii) such inspections or tests shall be conducted at the Buyers sole cost and
expense, and (iii) such inspections or tests shall not materially disrupt or disturb the ongoing
operation of the Business, the Transferred Real
35
Property or the rights of any tenants or users
thereof beyond a de minimis extent. In connection with the Phase II, the Buyer shall provide the
Company with an original certificate of insurance, in a form reasonably approved by the Company,
naming the Company, and each such other Person as the Company reasonably may name, as an
additional named insured. After making any tests and inspections pursuant to this Section
5.1(c), the Buyer agrees to promptly restore
the Transferred Real Property to substantially the same condition prior to such tests and
inspections, which obligation shall survive any termination of this Agreement. Prior to the
Closing, the Buyer agrees not to cause any lien to be imposed upon the Transferred Real Property
and to indemnify, defend and hold harmless the Company, the Transferring Subsidiary and their
Affiliates and respective directors, officers, managers, employees, agents, advisors,
Representatives, successors and assigns (collectively, the Seller Parties) from and
against any and all Losses by reason of any damage to the Transferred Real Property or injury to
Persons caused solely by the Buyer or any of its Affiliates, agents or other Representatives in
exercising their rights under this Section 5.1(c). The indemnity provided pursuant to
this Section 5.1(c) shall survive the Closing and any termination of this Agreement.
5.2 Conduct of the Business Prior to the Closing Date.
From the date hereof to the earlier of the Closing Date or the termination of this Agreement
(except as expressly permitted or required by this Agreement, as set forth in Schedule
5.2(a) attached hereto or to the extent the Buyer otherwise consents in writing, the Company
and the Transferring Subsidiary shall, and shall cause the other Company Parties to, (A) operate
the Transferred Assets and conduct the Business in the ordinary course of business consistent with
past practice and (B) use its reasonable best efforts to preserve the Business intact and retain
all Business Employees. Without limiting the foregoing, the Company and the Transferring
Subsidiary shall, and shall cause the other Company Parties to:
(a) perform in all material respects all of their respective obligations under the Contracts
in accordance with the terms thereof;
(b) pay and discharge all Liabilities related to the Transferred Assets or the Business as
they become due and payable in the ordinary course of business consistent with past practice
(subject to the Companys ability to pursue in good faith any bona fide disputes);
(c) comply in all material respects with all Laws applicable to the Transferred Assets or the
Business and, promptly following receipt thereof, give to the Buyer copies of any notice received
from any Governmental Authority or other Person alleging any violation of any such Laws;
(d) not sell, lease, assign, transfer, license, sublicense, encumber or otherwise dispose of,
in whole or in part, any of the Transferred Assets;
(e) not modify, change or otherwise alter in any material respect the fundamental nature of
the Transferred Assets or the Business;
(f) not cancel, rescind, terminate, renew, assign or make any material amendment or change to
any Contract, other than the expiration of a Contract in accordance with its terms as of the date
hereof;
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Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
(g) not incur, create or assume any indebtedness or Liabilities for borrowed money or
guarantee any such obligation which would constitute an Assumed Liability;
(h) (A) not incur, create, assume or suffer to exist any Lien on any Transferred Asset
(except for the Permitted Liens) unless such Lien is released upon or prior to the Closing and (B)
remove the Liens by Pfizer Incorporated and its Affiliates on any Transferred Assets, including
any Business Intellectual Property;
(i) except as required by any applicable Law, Governmental Authority or any Company Plan, not
(A) increase the compensation, bonus or benefits of any Business Employee, (B) loan or advance any
money or other property to any Business Employee, (C) establish, adopt, enter into, amend or
terminate any Company Plan or any plan, agreement, program, policy, trust, fund or other
arrangement that would be a Company Plan with respect to any Business Employee, (D) pay any
benefit or amount to any Business Employee not required under any Company Plan as in effect on the
date of this Agreement other than payment of normal wages and salary in the ordinary course of
business consistent with past practice, (E) grant any awards to any Business Employee under any
bonus, incentive, performance or other compensation plan, arrangement or Company Plan or (F) take
any action to accelerate the vesting or payment of any compensation or benefit under any Company
Plan;
(j) not terminate any Business Employee, except for cause (as such term is defined in a
contract with any such Business Employee or in the Companys personnel policies or practices);
(i) not effectuate a plant closing, mass layoff or other similar triggering event as those
terms are defined in the Worker Adjustment and Retraining Notification Act (WARN) or any
other applicable analogous Law, affecting in whole or in part the Identified Employees;
(ii) not institute, settle or agree to settle any Proceeding by or before any Governmental
Authority that creates or imposes any continuing obligation or restriction on the Transferred
Assets or would otherwise constitute an Assumed Liability;
(iii) not receive a license of the kind required to be disclosed on Schedule
4.1(q)(iv) and not sell, license or sublicense or otherwise transfer any rights to any third
party under any Business Intellectual Property;
(iv) not surrender, revoke or otherwise terminate any Licenses or Permits, except in
connection with any renewal or reissuance of any such License or Permit;
(v) not waive, release or assign any material rights, which rights, but for such waiver,
release or assignment, would have been classified as a Transferred Asset, other than in the
ordinary course of business consistent with past practice;
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(vi) preserve materially intact the goodwill of the Business;
(vii) maintain the Transferred Assets in reasonably good condition and repair in all material
respects and maintain Inventory and supplies at customary operating levels in the ordinary course
of business;
(viii) maintain insurance reasonably comparable to that in effect on the date hereof and, in
the event of a casualty, loss or damage to any Transferred Asset prior to the Closing Date for
which the Company is insured, either repair or replace such Transferred Asset or, if the Buyer
agrees, transfer the proceeds of such insurance to the Buyer at the Closing;
(ix) maintain the books, accounts and records relating to, used in or necessary for the
operation of the Business in accordance with past custom and practice and in accordance with GAAP,
as applicable;
(x) maintain in full force and effect all material Business Intellectual Property;
(xi) not take or omit to take any action that would reasonably be anticipated to have a
Material Adverse Effect; and
(xii) not authorize any of, or commit or agree, whether in writing or otherwise, to take any
of, the foregoing actions.
5.3 Acquisition Proposals. From the date hereof until the earlier of the Closing Date
or the termination of this Agreement (the Applicable Period), without limiting the
provisions of Section 5.2 hereof, the Company shall not, and shall cause its directors,
officers and Representatives not to, directly or indirectly, (i) solicit, initiate, knowingly
encourage or knowingly take any action designed to facilitate any inquiries or the making of any
proposal that constitutes an Acquisition Proposal, (ii) participate in any negotiations or
discussions regarding, or furnish to any Person any nonpublic information with respect to, any
Acquisition Proposal, (iii) approve, endorse or recommend any Acquisition Proposal or (iv) enter
into any letter of intent or similar document or any contract, agreement or commitment accepting
any Acquisition Proposal. For purposes of this Agreement, an Acquisition Proposal shall
mean any bona fide inquiry, proposal, request or offer from any third party relating to (A) any
direct or indirect acquisition or purchase of any material portion of the Transferred Assets or the
Business or (B) any merger, consolidation, business combination, recapitalization, liquidation,
dissolution or similar transaction involving the Company or the Transferring Subsidiary, unless, in
the case of
clause (B), such third party would be required to perform, or cause any Company Party to any
Transaction Document to perform, their obligations under each of the Transaction Documents and such
third party expressly affirms and assumes such obligations by written instrument, a copy of which
is promptly provided to the Buyer.
5.4 Non-Solicitation.
(a) Each of the Company and the Transferring Subsidiary agrees that, for a period of [***]
from and after the Closing Date, neither it nor any of its Subsidiaries shall, without the prior
written consent of the Buyer, directly or indirectly, solicit (i) any Transferred Employee or (ii)
any Person employed by the Buyer, the Intangibles Purchaser or any of their Affiliates who became
known to the Company or the Transferring Subsidiary in connection with the transactions
contemplated by this Agreement. Notwithstanding the foregoing, the restrictions set forth in this
Section 5.4(a) shall not apply to [***].
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Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
(b) Each of the Buyer and the Intangibles Purchaser agrees that, for a period of [***] from
and after the Closing Date, neither it nor any of its Subsidiaries shall, without the prior
written consent of the Company, directly or indirectly, solicit (i) any Business Employee that is
not a Transferred Employee or (ii) any Person employed by the Company, the Transferring Subsidiary
or any of their Affiliates who became known to the Buyer or the Intangibles Purchaser in
connection with the transactions contemplated by this Agreement. Notwithstanding the foregoing,
the restrictions set forth in this Section 5.4(b) shall not apply to [***].
(c) The parties agree that if, in the opinion of any court of competent jurisdiction, any of
the provisions contained in this Section 5.4 are not reasonable in any respect, then such
court shall have the right, power and authority to excise or modify such provision or provisions
of this Section 5.4 that such court may find unreasonable and to enforce the remainder of
the restrictions as so amended.
5.5 Further Actions; Efforts.
(a) Subject to the terms and conditions of this Agreement, each party thereto shall use its
commercially reasonable efforts to take, or cause to be taken, all actions and to do, or cause to
be done, all things necessary, proper or advisable under applicable Law to consummate the
Acquisition and the other transactions contemplated by this Agreement and the Transaction
Documents, including preparing and filing as promptly as practicable all documentation, if any, to
effect all necessary filings, notices, petitions, statements, registrations, submissions of
information, applications and other documents necessary to consummate the Acquisition and the
other transactions contemplated by this Agreement and the Transaction Documents, including under
the HSR Act and ARC.
(b) As soon as may be reasonably practicable and in any event within (i) fourteen (14) days
of the date hereof, the Company and the Buyer shall each file with the United States Federal Trade
Commission (the FTC) and the Antitrust Division of the United States Department of
Justice (the DOJ) the notification and report forms relating to the transactions
contemplated hereby as required by the HSR Act and (ii) twenty (20) days of the date hereof, the
Company and the Buyer shall each file with the German Federal Cartel Office (Bundeskartellamt)
(the GFCO) the notification and report forms relating to the transactions contemplated
hereby as required by the German Act against Restraints of Competition (Gesetz gegen
Wettbewerbsbeschraenkungen) (the ARC). The Company and the Buyer shall promptly (a)
supply the other with any information that may be required in order to effectuate such filings and
(b) supply any additional information that may reasonably be required by the FTC, the DOJ, the
GFCO or the competition or acquisition control authorities of any other jurisdiction and which the
Company and the Buyer may reasonably deem appropriate. Notwithstanding anything to the contrary
in this Section 5.5, the obligation to use commercially reasonable efforts in connection
with this Section 5.5 shall not require the Buyer, the Intangibles Purchaser, the Company,
the Transferring Subsidiary or any of their Affiliates to divest any business, asset or property
owned by any of them or to agree to any hold separate orders or conduct or licensing provisions
relating to any business, asset or property.
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Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
(c) In the event that any Proceeding or Order is instituted (or threatened to be instituted)
by a Governmental Authority or private party challenging the Acquisition or any other transaction
contemplated by this Agreement and the Transaction Documents, including under the HSR Act and ARC,
(i) the parties hereto shall cooperate in all respects with each other and use their commercially
reasonable efforts to contest and resist any such Proceeding or Order and to have vacated, lifted,
reversed or overturned any decree, judgment, injunction or other order, whether temporary,
preliminary or permanent, that is in effect and that prohibits, prevents or restricts consummation
of the transactions contemplated by this Agreement, and (ii) the parties hereto shall use their
commercially reasonable efforts to defend, each at their own cost and expense, any action or
actions, whether judicial or administrative, in connection with the transactions contemplated by
this Agreement and the Transaction Documents, including under the HSR Act and ARC.
5.6 Public Announcements. No party to this Agreement shall originate any publicity,
news release or other public announcement, written or oral, whether relating to this Agreement or
the existence of any arrangement between the parties, without the prior written consent of the
Company (in the case of origination by the Buyer or the Intangibles Purchaser) or the Buyer (in the
case of origination by the Company or the Transferring Subsidiary), whether named in such
publicity, news release or other public announcement or not, except where such publicity, news
release or other public announcement is required by law; provided, however, in such
event, the party issuing such publicity, news release or other public announcement shall still
be required to consult with the Company or the Buyer, as applicable, whether named in such
publicity, news release or public announcement or not, a reasonable time but no less than
forty-eight (48) hours prior to its release to allow the Company or the Buyer, as applicable, to
comment thereon and, after its release, shall provide the other party with a copy thereof. If any
party, based on the advice of its counsel, determines that this Agreement, or any of the other
documents executed in connection herewith, must be filed with the SEC, then such party, prior to
making any such filing, shall provide the Company or the Buyer, as applicable, and its counsel with
a version of this Agreement or any other related documents which it intends to file, showing any
proposed redactions, and will give due consideration to any comments provided by the Company or the
Buyer, as applicable, or its counsel and use reasonable efforts to ensure the confidential
treatment by the SEC of those sections specified by the Company or the Buyer, as applicable, or its
counsel.
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Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
5.7 Company Employee Benefits.
(a) As promptly as practicable after satisfaction or waiver (subject to applicable Law) of
the conditions (excluding conditions that, by their terms, are to be satisfied on the Closing
Date) set forth in Article VIII hereof, the Company shall deliver an updated Schedule
1.1(a) to the Buyer, which Schedule shall provide the Buyer with the job title, base salary
and other compensation provided each Business Employee. At least two (2) days prior to the
Closing Date, the Buyer shall deliver to the Company a list of the Business Employees to whom the
Buyer has made or intends to make offers of employment (each, an Identified Employee).
The Buyer shall offer employment, commencing on the Closing Date, to each Identified Employee,
each at a wage, salary and incentive compensation level that are substantially comparable in the
aggregate to those provided to such Identified Employee on the day preceding the Closing Date and
on such other employment terms and conditions Buyer deems appropriate, including Buyers
customary, confidentiality and non-solicitation agreements. Each Identified Employee who accepts
the offer of employment from the Buyer shall be a Transferred Employee for purposes of
this Agreement, effective as of the Closing Date (except for any Identified Employee who is
receiving either short-term or long-term disability benefits as of the Closing Date, which
individual shall become a Transferred Employee when he or she returns to active employment with
the Buyer). The Company shall be liable for all Severance Costs. For purposes of this Agreement,
the term Severance Costs shall mean, for each Identified Employee who does not accept
the offer of employment described above, the amount of severance payments and benefits to which
such employee would be entitled under any Company Plan that is a severance plan or agreement (as
in effect on the date hereof) applicable to such employee, as if his employment had been
involuntarily terminated on the Closing Date.
(b) From and after the Closing Date until the first anniversary of the Closing Date, the
Buyer shall provide the Transferred Employees, for so long as such Transferred Employees remain
employed by the Buyer or any of its Subsidiaries during such one (1) year
period, health benefits (which term shall include medical, dental, vision and other welfare
benefits but shall not include life insurance and post-retirement medical benefits) which are
substantially comparable, in the aggregate, to those provided to employees of a division of the
Buyer or any of its Subsidiaries that is of a size and nature, and in a geographic location,
substantially comparable to the Company and who are in positions comparable to the positions held
by such Transferred Employees with the Buyer or any of its Subsidiaries from time to time after
the Closing Date.
(c) Effective as of the Closing Date, the Company shall fully vest each Transferred Employee
(including any such Transferred Employee then on short-term or long-term disability) in his or her
account balance under the Companys 401(k) Plan (the 401(k) Plan) and such Transferred
Employees shall cease to participate in the 401(k) Plan as of the Closing Date. Effective on or
as soon as practicable after the Closing Date, each Transferred Employee shall be eligible to
commence participation in a 401(k) plan maintained by the Buyer (the Buyers 401(k)
Plan). The Buyers 401(k) Plan will recognize the months and years of service credited to
such employees under the 401(k) Plan for purposes of eligibility and vesting, but not for benefit
accrual. The Buyers 401(k) Plan will accept the transfer of a Transferred Employees account
balance under the 401(k) Plan, including any outstanding loans, provided that the Buyer determines
that the distribution and transfer of such amount constitutes an eligible rollover distribution
under the Code.
(d) The Company shall remain liable and retain responsibility for and continue to pay all
medical, life insurance and other welfare plan expenses, premiums or adjustments, and benefits for
each Business Employee with respect to claims incurred by such Business Employees on or prior to
the Closing Date. The Buyer shall be liable and responsible for all medical and other welfare
plan expenses, premiums or adjustments and benefits with respect to claims incurred by Business
Employees after the Closing Date. For purposes of this paragraph, a claim is deemed incurred: in
the case of medical benefits, when the services that are the subject of the claim are performed;
in the case of life insurance, when death occurs; and in the case of accidental death and
dismemberment, when the event giving rise to the claim occurs.
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Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
(e) From and after the Closing Date, the Buyer shall recognize each Transferred Employees
prior service with the Company, any of its Subsidiaries or a Person acquired by the Company to the
same extent such service was credited by the Company, in connection with those employee benefit
plans, programs or arrangements of the Buyer or any of its Affiliates (excluding Buyers Stock
Incentive Plan and any plan or program providing life insurance or post-retirement medical
benefits) in which any such employees are eligible to participate following the Closing Date, for
purposes of (i) eligibility, vesting and levels of paid time off or vacation and severance
benefits but not for purposes of benefit accruals under any
defined benefit pension plan; (ii) benefit eligibility or accrual under a retiree medical
plan or program (or its equivalent); or (iii) to the extent that such recognition would result in
duplication of benefits. From and after the Closing Date, and to the extent permitted by
applicable Law and/or applicable insurance providers and to the extent practicable and
commercially reasonable, the Buyer shall cause any pre-existing conditions or limitations and
eligibility waiting periods (to the extent such waiting periods would be inapplicable, taking into
account service with the Company and any of its Affiliates), under any group health plans of the
Buyer or any of its Affiliates in which the Transferred Employees are otherwise to become eligible
to participate after the Closing Date, to be waived with respect to such employees and their
eligible dependents. The Buyer shall give each Transferred Employee credit for any deductibles
and annual out-of-pocket limits for medical expenses paid during the applicable plan year in which
the Closing occurs under any welfare benefit plans (within the meaning of Section 3(i) of ERISA)
maintained or contributed to by the Company prior to the Closing in satisfying any deductibles and
annual out-of-pocket limits for medical expenses for the same plan year under any welfare plans
maintained or contributed to by the Buyer or its Affiliates in which such employees participate
during such year.
(f) Except as required by applicable Law, as of the Closing Date, the Transferred Employees
shall cease to accrue further benefits under the employee benefit plans and arrangements
maintained by the Company and its Affiliates. From and after the Closing Date, the Company shall
remain solely responsible for any and all Liabilities in respect of the Company Plans, except as
otherwise provided herein.
(g) Subject to Section 5.9 hereof, the Company shall be responsible for providing or
discharging any and all notifications, benefits and liabilities to Business Employees and
Governmental Authorities required by WARN or any other applicable Law, including but not limited
to, the California Labor Code and any similar state law in relation to the transactions
contemplated by this Agreement. At the Closing, the Company shall provide notice to Buyer setting
forth the number of employees of the Company terminated in the period that is ninety (90) days
prior to the Closing at any facility located in San Carlos, California.
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Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
(h) The Company shall be responsible for providing all Business Employees (and their
dependents) with any notices required by the Consolidated Omnibus Budget Reconciliation Act
(COBRA) with respect to any qualifying events that occur on or prior to the Closing Date
and retain all obligations with respect to continuation coverage under COBRA (and any similar
state law) and the regulations thereunder with respect to such qualifying events. The Buyer shall
be responsible for providing all Transferred Employees (and their dependents) with any notices
required by COBRA with respect to any qualifying events that occur following the Closing Date and
retain all obligations with respect to any qualifying events that occur following the Closing Date
and retain all obligations with respect to continuation coverage under COBRA (and any similar
state law) and the regulations thereunder with respect to such qualifying events.
(i) No provision of this Agreement shall create any third party beneficiary rights in any
Business Employee, any beneficiary or dependent thereof or any collective bargaining
representative thereof, with respect to the compensation, terms and conditions of employment or
benefits that may be provided to any Transferred Employee by the Buyer or any of its Affiliates
under any benefit plan that Buyer or any of its Affiliates may maintain, or otherwise. Nothing
herein shall be construed as an amendment to any Company Plan for any purpose.
(j) The Company will pay, on or prior to the Closing Date, each Transferred Employee a bonus
in an amount equal to each Transferred Employees 2008 annual bonus target under the Companys
Discretionary Performance-Based Incentive Compensation Policy for the 2008 calendar year,
determined on a prorated basis for the period from January 1, 2008 to the Closing Date, payable to
such Transferred Employee.
(k) The Company shall retain liability for all Company-issued stock options, restricted stock
units and any other equity or equity equivalents of the Company held by the Transferred Employees
as of the Closing Date.
(l) Notwithstanding anything herein to the contrary, each Business Employee who is receiving
short-term or long-term disability benefits as of the Closing Date will continue employment with
the Company until he or she is able to return to active employment. At such time, the Buyer will
offer any such Business Employee employment on the same terms as set forth in Section
5.7(a) hereof.
(m) The Company and the Buyer will cooperate with respect to any employee communications
regarding the matters provided for herein. Until the Closing Date, the Company will allow the
Buyer and its representatives and agents access, upon reasonable notice, during normal working
hours to the personnel, including arranging and effectuating meetings with Business Employees,
provided that, by the Closing Date, the Company shall have delivered to or furnished Buyer with
the complete employment and personnel files of each Identified Employee (except to the extent
information is protected by any applicable Law after giving effect to any consent or waiver given
by such Identified Employee). Buyer shall have the right to review any and all notices provided
to the Business Employees in connection with the transactions contemplated before any such notice
is distributed to such Employees. The Company shall have the right to review any and all
communications, offer letters, employment agreements, confidentiality agreements, and non-compete
or non-solicitation agreements that Buyer intends to provide to any Identified Employee before any
such communication, offer letter or agreement is provided to an Identified Employee.
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Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
(n) Immediately prior to the Closing, the Transferred Employees will cease to contribute to
the Companys Section 125 Plan (the Companys 125 Plan) and the Companys 125 Plan will
reimburse the Transferred Employees for those claims (if any) they
incurred prior to the Closing Date. Contributions will be made to any Transferred
Employees accounts under the Companys 125 Plan for compensation earned before but not after the
Closing Date. Transferred Employees who were participants in the Companys 125 Plan for the 2008
plan year will become participants in the section 125 plan maintained by the Buyer as of the
Closing Date (the Buyers 125 Plan) as if their participation in the Buyers 125 Plan
had been continuous from January 1, 2008. Each Transferred Employee will be reimbursed for
medical and dependent care expenses incurred by him or her at any time during 2008 (including
claims incurred before the Closing Date), up to the amount of the elections made by each
Transferred Employee under the Companys 125 Plan for 2008, reduced by amounts previously
reimbursed by the Company pursuant to the Companys 125 Plan in 2008. To effectuate the
foregoing, as soon as administratively practicable after the Closing Date, the Company will notify
the Buyer whether the amounts of the account balances (if any) under the Companys 125 Plan are
positive or negative in the aggregate immediately prior to the Closing Date, and the Company will
pay the Buyer such aggregate balance (if positive) or the Buyer will pay the Company such
aggregate balance (if negative), with respect to all Transferred Employees who become participants
in the Buyers 125 Plan for the 2008 plan year.
5.8 Certain Notices. From and after the date of this Agreement until the Closing, the
Company and the Buyer shall promptly notify each other orally and in writing of (a) any notice or
other communication from any Person alleging that the Consent of such Person may be required in
connection with the Transferred Assets, including the Transferred Shares, and (b) any Proceedings
commenced or, to the Knowledge of the Company or the knowledge of the Buyer, as the case may be,
threatened in writing against, relating to or involving or otherwise affecting such party or any of
its Subsidiaries that, if pending on the date of this Agreement, would have been required to be
disclosed pursuant to Article IV or that relate to the transactions contemplated by this
Agreement or (c) any breach of a representation or warranty of such party which such party expects
will make it unable to satisfy any condition of such party set forth in Article VIII
hereof.
5.9 WARN. Subject to Section 5.7(f) hereof, the Buyer shall not, at any time
within the ninety (90) day period following the Closing Date, effectuate a plant closing, mass
layoff or other similar triggering event as those terms are defined in the WARN or any other
similar applicable Law, affecting in whole or in part any site of employment, facility or operating
unit of the Business that results in the loss of employment of any Transferred Employees.
Notwithstanding any other provision of this Agreement, the Company shall retain any and all
Liabilities under WARN arising from the Acquisition in respect to all employees of the Company
other than Transferred Employees.
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Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
5.10 Confidentiality. (a) The parties hereto and/or their respective Affiliates have
disclosed, and may hereafter from time to time in the course of the performance of this
Agreement and the other Transaction Documents disclose for a period of [***] after the date
hereof, proprietary, secret or confidential data and information (Confidential
Information) to the other parties hereto. For the avoidance of doubt, all such data and
information relating to the Business or the Transferred Assets, other than those related to the
Retained Assets (collectively, Business Confidential Information), is Confidential
Information of Buyer. Except as expressly permitted by this Agreement or a Transaction Document,
the Company and the Transferring Subsidiary shall, and shall cause their respective Affiliates to,
hold in confidence all Confidential Information of the Buyer, the Intangibles Purchaser and their
Affiliates. Notwithstanding the foregoing, the receiving party may disclose Confidential
Information of the disclosing party to the receiving partys directors, officers, employees,
Affiliates, consultants, subcontractors, sublicensees, agents or external advisors on a need to
know basis, and solely to the extent reasonably necessary to carry out its obligations under this
Agreement or the Transaction Documents, provided that such directors, officers, employees,
Affiliates, consultants, subcontractors, sublicensees, agents or external advisors have been
advised of the confidential nature of such information and have agreed to maintain such information
as confidential and comply with non-use obligations to the same extent required by, and as
stringent as, this Section 5.10.
(b) Confidential Information shall not include information that the receiving party can
demonstrate:
(i) was known by the receiving party or its Affiliates prior to the date it was disclosed to
the receiving party or its Affiliates by the disclosing party or its Affiliates, as evidenced by
the prior written records of the receiving party or its Affiliates, provided that this exception
will not apply, in the case of the Company, to any Business Confidential Information;
(ii) is lawfully disclosed to the receiving party or its Affiliates by a third party
rightfully in possession of such information without an obligation of confidentiality after the
date of the disclosure to the receiving party or the Affiliates;
(iii) becomes generally known to the public through no act or omission on the part of the
receiving party or its Affiliates, either before or after the date of the disclosure to the
receiving party or its Affiliates; or
(iv) is independently developed by the receiving party or its Affiliates without reference or
access to, or reliance upon, any Confidential Information of the disclosing party or its Affiliates
as demonstrated by the receiving partys written records.
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Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
(c) The restrictions set forth in this Section 5.10 shall not prevent either party
from (i) disclosing Confidential Information in connection with preparing, filing, prosecuting or
maintaining the Licensed Intellectual Property (as defined in the Exclusive License Agreement) in
accordance with the Exclusive License Agreement, (ii) disclosing Confidential Information to governmental agencies to the extent required by applicable Laws
or desirable to obtain a regulatory approval, (iii) disclosing Confidential Information to
potential private financial institution investors (under a confidentiality agreement at least as
restrictive as the provisions of this Section 5.10) in connection with fundraising
activities, (iv) disclosing Confidential Information to underwriters and financial advisors (under
an obligation of confidentiality at least as restrictive as the provisions of this Section
5.10) in connection with the public offering of securities, (v) disclosing Confidential
Information that is reasonably determined is required to be disclosed by the receiving party
pursuant to a judicial or governmental order, or to public investors or governmental agencies (to
comply with applicable securities or other laws) in connection with the public offering of
securities, or (vi) disclosing Confidential Information as required pursuant to the exercise by
each Party of its rights granted to it under this Agreement or its retained rights (under an
obligation of confidentiality at least as restrictive as the provisions of this Section
5.10); provided that in the cases of (i), (ii) and (v) above, the party disclosing
Confidential Information of the disclosing party shall use all reasonable efforts to provide prior
written notice of such disclosure to the disclosing party and to take reasonable and lawful
actions to avoid or limit such disclosure (such as seeking a protective order) or to assist the
disclosing party in avoiding or limiting such disclosure.
5.11 Required Notices, Approvals and Consents. The Company shall (i) provide all
notices to third parties as required pursuant to the terms of, or as otherwise required by, any of
the Contracts; (ii) use its commercially reasonable efforts (A) to obtain all consents required to
effect the assignment of the Contracts to the Buyer and (B) to obtain an estoppel certificate from
the Landlord in form and substance reasonably acceptable to the Buyer from the Landlord; (iii) file
or submit, to the FDA or any other Governmental Authority, all such duly executed filings and
submissions as are necessary to transfer the rights to the Licenses and Permits (to the extent so
transferable) to the Buyer; and (iv) make such filings as are reasonably necessary to transfer, to
the extent so transferable from the Company under applicable Law, all special permits or licenses
issued by the state or municipality in which the Transferred Real Property is located (including
any environmental protection permits).
5.12 Availability of Records.
(a) After the Closing, the Company and the Transferring Subsidiary, on the one hand, and the
Buyer and the Intangibles Purchaser, on the other hand, (i) shall cooperate to promptly effectuate
the copying and delivery of the Corporate Records and Business Records to which the Buyer or the
Intangibles Purchaser are entitled to have copies hereunder and (ii) shall make available to each
other party and its respective Affiliates and Representatives, during normal business hours when
reasonably requested (including in relation to any filing required to be made with the SEC), all
other information, records and documents related to the Transferred Assets or the Business Records
in its possession and shall preserve the same until the later of (A) six (6) years after the
Closing, (B) the expiration of all statutes of limitations for assessing or collecting Taxes for
periods ending on or prior to the Closing and periods including the Closing Date, including
extensions thereof applicable to the Company or the Buyer, or (C) the required retention period
under any applicable Law for all such information, records or documents (it being understood that
the parties shall not be required to provide any Tax returns to any Person, other than as required
by applicable Law). The Buyer, the Intangibles Purchaser, the Company and the Transferring
Subsidiary shall also make available to each other during
normal business hours, when reasonably requested, personnel responsible for preparing or
maintaining information, records and documents in connection with Tax matters, governmental
contracts, litigation or potential litigation, each as it relates to the Business, the Transferred
Assets or Assumed Liabilities prior to the Closing (with respect to the Company) or from and after
the Closing Date (with respect to the Buyer), including products liability and general insurance
liability.
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Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
(b) Following the Closing, each of the Company and the Transferring Subsidiary will afford to
the Buyer and the Intangibles Purchaser and their counsel and accountants, and each of the Buyer
and the Intangibles Purchaser will afford to the Company and the Transferring Subsidiary and their
counsel and accountants, during normal business hours, reasonable access to the Corporate Records
or the Business Records, as applicable, in its respective possession with respect to periods prior
to the Closing (in the case of Corporate Records in the possession of the Company or the
Transferring Subsidiary) or the after the Closing (in the case of Business Records in the
possession of the Buyer or the Intangibles Purchaser) and the right to make copies and extracts
therefrom, to the extent that such access may be reasonably required by the applicable party
hereto to facilitate the investigation, litigation and final disposition of any claims that may
have been or may be made against such party or its Affiliates, or for any other reasonable
business purpose, relating to the Business, the Transferred Assets or the Assumed Liabilities (in
the case of Buyer or the Intangibles Purchaser) or the Business, the Retained Assets or the
Retained Liabilities (in the case of the Company or the Transferring Subsidiary). The applicable
partys agents shall keep confidential and not disclose any information learned as a result of any
examination conducted pursuant to this Section 5.12(b) to any other Person without the
prior consent of the Company (in the case of the Buyer or the Intangibles Purchaser) or the Buyer
(in the case of the Company or the Transferring Subsidiary), unless (i) the disclosure is in
response to legal order or subpoena or (ii) the information is readily ascertainable from public
or published information or trade sources without violation of the foregoing provisions of this
sentence. The Buyer or the Company, as applicable, shall reimburse the other for reasonable
out-of-pocket costs and expenses incurred in assisting the requesting party pursuant to this
Section 5.12(b). None of the parties hereto shall be required by this Section
5.12(b) to take any action that would unreasonably interfere with the conduct of its business
or unreasonably disrupt its normal operations.
(c) Subject to Section 5.10 hereof, the Company may retain a copy of any Business
Records that are transferred to the Buyer or the Intangibles Purchaser and the Buyer or the
Tangibles Purchaser may retain a copy of any Corporate Records of which the Buyer or the
Intangibles Purchaser may receive a copy pursuant to this Agreement, and each party hereto
consents and agrees to retain such records in accordance with the Companys standard retention
policies and practices.
5.13 [***].
5.14 [***].
(a) [***].
(b) [***].
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Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
5.15 SEDS Option.
(a) [***].
(b) [***].
(c) To the extent the Buyer or the Intangibles Purchaser does not provide the Company with
the SEDS Notice prior to the expiration of the SEDS Option Period, the Buyer will forfeit all of
its rights to acquire SEDS Intellectual Property pursuant to this Agreement and this Section
5.15 shall automatically expire and be of no further force or effect.
(d) Nektar UK is executing and delivering a copy of this Agreement solely with respect to
this Section 5.15 and Article XI hereof and the Buyer and the Intangibles
Purchaser may enforce this Section 5.15 directly against the Company, the Transferring
Subsidiary and/or Nektar UK.
5.16 [***].
5.17 [***].
5.18 [***]. (a)
(i) [***]; and
(ii) [***].
[***].
(b) [***].
5.19 Parking Spaces. For so long as the Company is a tenant at 201 Industrial Road in
San Carlos, California, the Company shall provide to the Buyers employees located at the
Transferred Real Property, at no cost, such access to Parking Lot B as necessary to comply with
applicable regulations and ordinances. The Company shall give Buyer written notice at
least thirty (30) days prior to the termination of its lease at 201 Industrial Road, San
Carlos, California.
5.20 [***].
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Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
ARTICLE VI
TAX MATTERS
6.1 Company Tax Returns. The Company and the Transferring Subsidiary shall be
responsible for the preparation and filing of all Tax Returns required to be filed by the Company,
the Transferring Subsidiaries and any of their Affiliates that include items with respect to the
Business and the Transferred Assets. The Company and the Transferring Subsidiary shall make all
payments required with respect to any such Tax Return, provided that the Buyer shall promptly
reimburse the Company for any Taxes for which the Buyer or the Intangibles Purchaser is responsible
under this Agreement upon written notice from the Company of the amount of such Taxes together with
appropriate documentation.
6.2 Buyer Tax Returns. The Buyer and the Intangibles Purchaser shall be responsible
for the preparation and filing of all Tax Returns required to be filed by the Buyer, the
Intangibles Purchaser and any of their Affiliates that include items with respect to the Business
and the Transferred Assets. The Buyer and the Intangibles Purchaser shall make all payments
required with respect to any such Tax Return, provided that the Company shall promptly reimburse
the Buyer for any Taxes for which the Company or the Transferring Subsidiary is responsible under
this Agreement upon written notice from the Buyer of the amount of any such Taxes together with
appropriate documentation.
6.3 Assistance. Each of the Company, the Transferring Subsidiary, the Buyer and the
Intangibles Purchaser shall, at their own expense:
(a) provide reasonable assistance to any other party in preparing any Tax Returns which such
other party is responsible for preparing and filing in accordance with this Article VI;
(b) provide reasonable assistance to any other party in preparing for any audits of, or
disputes with Taxing authorities regarding, any Tax Returns relating to the Transferred Assets;
(c) make available to any other party and to any Taxing authority, as reasonably requested,
all information, records and documents relating to Taxes related to the Transferred Assets;
(d) provide timely written notice to any other party of any Tax Proceeding with respect to
the Transferred Assets for taxable periods for which such other party may have a Liability under
this Article VI;
(e) furnish any other party with copies of all correspondence received from any Taxing
authority in connection with any Tax Proceeding with respect to any taxable period for which such
other party may have a Liability under this Agreement; and
(f) retain any books and records that could reasonably be expected to be necessary or useful
in connection with the Companys, the Transferring Subsidiarys, the Buyers or the Intangibles
Purchasers preparation, as the case may be, of any Tax Return, or for any Tax Proceeding related
to the Transferred Assets. Such books and records shall be retained until the expiration of the
applicable statute of limitations, including extensions thereof; provided,
however, that in the event a Tax Proceeding has been instituted prior to the expiration of
the applicable statute of limitations or in the event of any claim under this Agreement, the books
and records shall be retained until there is a final determination thereof and the time for any
appeals has expired.
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Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
6.4 Transfer Taxes. The Company shall be responsible for the timely payment (on an
after-tax basis) of, and shall indemnify the Buyer, the Intangible Purchaser and their respective
Affiliates for, all Transfer Taxes; provided, however, that all California sales
taxes arising out of or in connection with or attributable to the transactions effected pursuant to
this Agreement shall be [***] by the Company and the Buyer, and the Buyer or the Company, as the
case may be, shall promptly reimburse the other party for its share of such sales taxes upon
written notice from the other party of the amount of such sales taxes together with appropriate
documentation. The Company shall use commercially reasonable efforts to determine whether the
transactions effected pursuant to this Agreement qualify for an exemption from sales tax, provided,
that the decision to claim any such exemption (on a Tax Return or otherwise) is within the
Companys sole discretion. If the Company claims an exemption from sales tax, and the exemption is
later denied by the taxing authority or a court of competent jurisdiction, the Buyer shall promptly
reimburse the Company for [***] of the California sales tax determined to be due and [***] of the
interest assessed thereon. The Company, the Transferring Subsidiary, the Buyer and Intangibles
Purchaser shall use their respective commercially reasonable efforts to deliver or facilitate
delivery, as applicable, certain of the Transferred Assets, as appropriate, through an electronic
delivery or in such other manner reasonably calculated and legally permitted, and take all other
commercially reasonable actions necessary, to minimize or avoid the incurrence of Transfer Taxes.
ARTICLE VII
CLOSING
7.1 Closing Date. Unless this Agreement shall have been terminated and the
transactions herein shall have been abandoned pursuant to Article IX hereof, the closing of
the transactions contemplated by this Agreement (the Closing) shall take place at the
offices of
Kaye Scholer LLP located at 425 Park Avenue, New York, New York 10022 at 10:00 a.m. New York
time on the date (the Closing Date) that is the later of (a) December 31, 2008 and (b)
five (5) Business Days after satisfaction or waiver (subject to applicable Law) of the conditions
(excluding conditions that, by their terms, are to be satisfied on the Closing Date) set forth in
Article VIII, or at such other time or date as agreed to in writing by the parties hereto.
Notwithstanding the foregoing, the Closing shall for all purposes be deemed to occur at 11:59 p.m.
Eastern Standard Time on the Closing Date.
ARTICLE VIII
CONDITIONS PRECEDENT
8.1 Conditions Precedent to Obligations of Parties. The respective obligations of
each of the parties hereto to effect the Acquisition are subject to the satisfaction or waiver, at
or prior to the Closing Date, of each of the following conditions:
(a) No Injunctions; Illegality. At the Closing Date, there shall be no Order or
other legal restraint or prohibition of any nature of any court or Governmental Authority of
competent jurisdiction that is in effect that restrains or prohibits the consummation of the
Acquisition. There shall not be any action taken, or any statute, rule or regulation enacted,
entered, enforced or deemed applicable to the Acquisition, by any Governmental Authority which
makes the consummation of the Acquisition illegal.
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17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
(b) Governmental Consents. All material consents, approvals and authorizations of
any Governmental Authority, including under the HSR Act and ARC, required to be made or obtained
by the Company, the Transferring Subsidiary, the Buyer or the Intangibles Purchaser or any of
their respective Affiliates to consummate the Acquisition, shall be in full force and effect.
(c) No Proceedings. There shall not be pending or threatened any investigation or
Proceeding to which a Governmental Authority is a party, including under the HSR Act and ARC, (i)
seeking to restrain or prohibit the consummation of the transactions contemplated hereby or (ii)
seeking to prohibit or limit the ownership or operation by the Buyer, the Intangibles Purchaser,
the Company or the Transferring Subsidiary of any material portion of the Transferred Assets or
the Business.
8.2 Conditions to Obligations of the Buyer and the Intangibles Purchaser. The
obligations of the Buyer and the Intangibles Purchaser to effect the Acquisition are subject to the
satisfaction (unless waived by the Buyer), at or prior to the Closing Date, of each of the
following conditions:
(a) Representations and Warranties. Each of the representations and warranties of
the Company or the Transferring Subsidiary set forth in this Agreement that are qualified as to
materiality shall be true and correct in all respects, and those not so qualified shall be true
and correct in all material respects, as of the date of this Agreement and (except to the extent
such representations and warranties speak as of any earlier date) as of the Closing Date as though
made on and as of the Closing Date, and the Buyer shall have received a certificate signed on
behalf of the Company by the Chief Executive Officer and the Chief Financial Officer of the
Company to such effect.
(b) Performance of Obligations of the Company. Each of the Company and the
Transferring Subsidiary shall have performed or complied, in all material respects, with all of
its respective obligations required to be performed or complied with by it under this Agreement at
or prior to the Closing Date, and the Buyer shall have received a certificate signed on behalf of
the Company by the Chief Executive Officer and Chief Financial Officer of the Company to such
effect.
(c) Assignment and Conveyance Instruments. The Buyer shall have received an
Assignment and Assumption Agreement, in a form mutually agreed by the Company and the Buyer (the
Assignment and Assumption Agreement), duly executed and delivered by the Company and the
Transferring Subsidiary and any other assignment and conveyance instruments required under
Section 2.3 hereof, including such instruments as are necessary to effect the valid
transfer to the Buyer or the applicable the Intangibles Purchaser of the Specified Equipment.
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17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
(d) Service Agreements. The Buyer shall have received the Services Agreements duly
executed and delivered by the Company.
(e) Exclusive License Agreement. The Buyer shall have received the Exclusive License
Agreement duly executed and delivered by the Company.
(f) FIRPTA Certificate. The Company and the Transferring Subsidiary shall each have
delivered to Buyer a certificate in form and substance reasonably satisfactory to Buyer, duly
executed and acknowledged, certifying any facts that would exempt the transactions contemplated
hereby from withholding under section 1445 of the Code and the Treasury Regulations promulgated
thereunder.
(g) Opinions of the Companys Counsel. The Buyer shall have received opinions dated
the Closing Date from each of the counsel to the Company, substantially in the forms of
Exhibit E and Exhibit F.
(h) Consents and Permits. The written consents to the transfer and assignment of the
Contracts set forth in Schedule 8.2(i) attached hereto shall have been obtained.
(i) Other Documents. The Buyer shall have received such other documents and
instruments as counsel for the Buyer and the Company mutually agree to be reasonably necessary to
consummate the transactions described herein.
(j) No Litigation. There shall not be pending any meritorious Proceeding to which a
third party is a party (i) seeking to restrain or prohibit the consummation of the transactions
contemplated hereby or (ii) seeking to prohibit or limit the ownership or operation by the Buyer,
the Intangibles Purchaser, the Company or the Transferring Subsidiary of any material portion of
the Transferred Assets or the Business.
8.3 Conditions to the Obligations of the Company and the Transferring Subsidiary. The
obligations of the Company and the Transferring Subsidiary to effect the Acquisition are subject to
the satisfaction (unless waived by the Company), at or prior to the Closing Date, of each of the
following conditions:
(a) Representations and Warranties. Each of the representations and warranties of
the Buyer or the Intangibles Purchaser set forth in this Agreement that are qualified as to
materiality shall be true and correct in all respects, and those not so qualified shall be true
and correct in all material respects, as of the date of this Agreement and (except to the extent
such representations and warranties speak as of any earlier date) as of the Closing Date as though
made on and as of the Closing Date, and the Company shall have received a certificate signed on
behalf of the Buyer by the Chief Executive Officer and the Chief Financial Officer of the Buyer to
such effect.
(b) Performance of Obligations of the Buyer. Each of the Buyer and the Intangibles
Purchaser shall have performed or complied, in all material respects, with all of its respective
obligations required to be performed or complied with by it under this Agreement at or prior to
the Closing Date, and the Company shall have received a certificate signed on behalf of the Buyer
by the Chief Executive Officer and Chief Financial Officer of the Buyer to such effect.
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(c) Purchase Price. The Company shall have received the Purchase Price at the
Closing in full in cash by wire transfer of immediately available funds to an account designated
by the Company at least two (2) Business Days prior to the Closings.
(d) Assignment and Conveyance Instruments. The Company shall have received the
Assignment and Assumption Agreement duly executed and delivered by the Buyer
and the Intangibles Purchaser and any other assignment and conveyance instruments required
under Section 2.3 hereof.
(e) Service Agreements. The Company shall have received the Buyer Service Agreement
and the Transition Services Agreement duly executed and delivered by the Buyer.
(f) Exclusive License Agreement. The Company shall have received the Intellectual
Property License agreement duly executed and delivered by the Intangibles Purchaser.
(g) Other Documents. The Company shall have received such other documents and
instruments as counsel for the Buyer and the Company mutually agree to be reasonably necessary to
consummate the transactions described herein.
ARTICLE IX
TERMINATION
9.1 Termination. This Agreement may be terminated and the Acquisition contemplated
hereby may be abandoned at any time prior to the Closing:
(a) by mutual written consent of the Buyer and the Company;
(b) by either the Company or the Buyer, upon written notice to the other party, in the event
the Acquisition shall not have been consummated within one (1) year of the date hereof (the
Termination Date); provided, however, that the right to terminate this
Agreement under this Section 9.1(b) shall not be available to any party whose failure to
fulfill any obligation under this Agreement has been the primary cause of, or resulted in, the
failure of such consummation to occur on or before the Termination Date;
(c) by either the Company or the Buyer, upon written notice to the other party, if any
Governmental Authority shall have issued an Order or taken any other action (which the parties
shall have used their respective reasonable best efforts to resist, resolve or lift, as
applicable, in accordance with Section 5.5 hereof) permanently restraining, enjoining or
otherwise prohibiting the transactions contemplated by this Agreement and such Order shall have
become final and nonappealable;
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(d) by the Buyer, upon written notice to the Company, if there shall have been a breach of
any representation, warranty, covenant or agreement on the part of the Company or the Transferring
Subsidiary contained in this Agreement, which breach would, individually or in the aggregate
together with all such other then uncured breaches by the
Company and the Transferring Subsidiary, constitute grounds for the conditions set forth in
Section 8.2(a) or (b) not to be satisfied at the Closing Date and such breach is
not reasonably capable of being cured (i) prior to the Termination Date or (ii) if such breach is
reasonably capable of being cured prior to the Termination Date, such breach shall not have been
cured prior to the earlier of (A) thirty (30) days after the Buyer has provided to the Company
written notice of such breach and (B) three (3) Business Days prior to the Termination Date; or
(e) by the Company, upon written notice provided to the Buyer, if there shall have been a
breach of any representation, warranty, covenant or agreement on the part of the Buyer or the
Intangibles Purchaser contained in this Agreement which breach would, individually or in the
aggregate together with all such other then uncured breaches by the Buyer and the Intangibles
Purchaser, constitute grounds for the conditions set forth in Section 8.3(a) or
(b) not to be satisfied at the Closing Date and such breach is not reasonably capable of
being cured (i) prior to the Termination Date or (ii) if such breach is reasonably capable of
being cured prior to the Termination Date, such breach shall not have been cured prior to the
earlier of (A) thirty (30) days after the Company has provided to the Buyer written notice of such
breach and (B) three (3) Business Days prior to the Termination Date.
9.2 Effect of Termination. In the event of termination of this Agreement by either
the Company or the Buyer as provided in Section 9.1 hereof, this Agreement shall forthwith
become null and void and there shall be no liability or obligation on the part of the parties
hereto or their respective officers, directors or other Affiliates, except for Section 5.6,
Section 5.10, this Section 9.2, Article X and Article XI, each of
which shall survive termination; provided, however, that nothing herein shall
relieve any party from liability for any intentional and material breach of any of the
representations, warranties, covenants or agreements set forth in this Agreement.
ARTICLE X
INDEMNIFICATION
10.1 Indemnification by the Company.
(a) From and after the Closing, the Company and the Transferring Subsidiary, jointly and
severally, shall indemnify the Buyer, the Intangibles Purchaser, their respective Affiliates and
each of their respective officers, directors, employees, stockholders, agents and representatives
against, and hold them harmless, from and against, any and all Losses, as incurred (payable
promptly upon written request), arising from, in connection with or otherwise with respect to:
(i) any breach of any representation or warranty of the Company or the Transferring Subsidiary
contained in this Agreement or any Transaction Document or in any certificate executed by the
Company or the Transferring Subsidiary for the benefit of the Buyer or the Intangibles Purchaser
delivered in connection herewith;
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(ii) the failure by the Company or the Transferring Subsidiary to perform any covenant,
agreement, obligation or undertaking contained in this Agreement, including Section 11.3
hereof, or any Transaction Document;
(iii) any Retained Liability or the operation or ownership of the Retained Assets, except to
the extent any such Loss results from a failure by the Buyer or the Intangibles Purchaser to
perform any covenant, agreement, obligation or undertaking contained in this Agreement or any
Transaction Document;
(iv) any Excluded Taxes; and
(v) any fees, expenses or other payments incurred or owed by the Company, the Transferring
Subsidiary or any of their respective Affiliates to any brokers, financial advisors or comparable
other persons retained or employed by it in connection with the transactions contemplated by this
Agreement.
(b) Notwithstanding anything to the contrary in this Agreement, any Transaction Document or
any certificate or agreement executed by the Company or the Transferring Subsidiary for the
benefit of the Buyer or the Intangibles Purchaser delivered in connection herewith, the Company
and the Transferring Subsidiary shall not have any liability:
(i) under Section 10.1(a)(i) unless the aggregate of all Losses for which the Company
and the Transferring Subsidiary would, but for this clause (i), be liable under Section
10.1(a)(i) exceeds, on a cumulative basis, an amount equal to [***] of such Losses;
provided, however, that this clause (i) shall not apply to any claim for
indemnification arising out of (x) fraud (including any willful misrepresentation or willful
concealment) by or on behalf of the Company or the Transferring Subsidiary or (y) a breach or
alleged breach of [***]; or
(ii) under Section 10.1(a)(i) in excess of [***] in the aggregate; provided,
however, that this clause (ii) shall not apply to any claim for indemnification arising out
of (x) fraud (including any willful misrepresentation or willful concealment) by or on behalf of
the Company or the Transferring Subsidiary or (y) a breach or alleged breach of [***].
For the avoidance of doubt, the limits set forth in this Section 10.1(b) shall apply only to such
claims made pursuant to Section 10(a)(i) and shall not limit claims made in respect of the
same subject matter pursuant to another provision of this Agreement or otherwise.
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10.2 Indemnification by the Buyer. From and after the Closing, the Buyer and the
Intangibles Purchaser, jointly and severally, shall indemnify the Company, the Transferring
Subsidiary, their respective Affiliates and each of their respective officers, directors,
employees, stockholders, agents and representatives against, and hold them harmless from and
against, any
and all Losses, as incurred (payable promptly upon written request), arising from, in
connection with or otherwise with respect to:
(a) any breach of any representation or warranty of the Buyer or the Intangibles Purchaser
contained in this Agreement, any Transaction Document or in any certificate executed by the Buyer
or the Intangibles Purchaser for the benefit of the Company or the Transferring Subsidiary
delivered in connection herewith;
(b) the failure by the Buyer or the Intangibles Purchaser to perform any covenant, agreement,
obligation or undertaking contained in this Agreement or any Transaction Document; and
(c) any Assumed Liability or the ownership or operation of the Transferred Assets by the
Buyer, the Intangible Purchaser or their respective Affiliates, except to the extent any such Loss
results from a failure by the Company or the Transferring Subsidiary to perform any covenant,
agreement, obligation or undertaking contained in this Agreement or in any Transaction Document.
10.3 Termination of Indemnification. (i) The obligations to indemnify and hold
harmless any party, pursuant to Section 10.1(a)(i) or 10.2(a), shall terminate when
the applicable representation or warranty terminates pursuant to Section 10.5; and (ii) the
other clauses of Sections 10.1 and 10.2, shall not terminate; provided,
however, that such obligations to indemnify and hold harmless shall not terminate with
respect to any item as to which the person to be indemnified pursuant to this Article X (an
indemnified party) shall have, before the expiration of the applicable period, previously
made a claim by delivering a written notice of such claim pursuant to Section 10.4 hereof
to the party to be providing such indemnification (an indemnifying party).
10.4 Procedures.
(a) Procedures for Third Party Claims.
(i) If a claim by a third party is made against an indemnified party arising out of a matter
for which such indemnified party is entitled to be indemnified under this Agreement (a Third
Party Claim), such indemnified party shall promptly notify the indemnifying party in writing
of such claim. The failure to notify promptly the indemnifying party hereunder shall not relieve
the indemnifying party of its obligations hereunder except to the extent that the indemnifying
party is actually and materially prejudiced by such failure. The indemnifying party shall be
responsible for the reasonable fees and expenses of counsel employed by the indemnified party,
provided that in no event shall the indemnifying party be liable for the fees and expenses
of more than one such counsel (in addition to the reasonable fees
of one local counsel) for all indemnified parties in connection with any one action or
separate but similar or related actions arising out of the same general allegations or
circumstances.
(ii) The indemnifying party shall be entitled to participate in the defense of a Third Party
Claim, individually or jointly, through their counsel, at their own expense, provided that
with respect to any Third Party Claim, the indemnified party shall control all proceedings taken in
connection with such Third Party Claim and, without limiting the foregoing, may in its sole
discretion, subject to Section 10.4(a)(iii), either pay the amount claimed and sue for a
refund where applicable Law permits such refund suits, settle or contest the Third Party Claim in
any permissible manner.
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(iii) So long as the indemnifying party is participating in the defense of a Third Party Claim
in good faith, the indemnified party shall reasonably cooperate with the indemnifying party by (x)
providing records, information and testimony that are reasonably relevant to such Third Party
Claim, including any counterclaims filed by the indemnified party, (y) providing access to
properties and individuals as reasonably requested by the indemnified party and (z) attending such
conferences, discovery proceedings, hearings, trials, appeals and other proceedings as may be
reasonably requested in connection therewith, in each case at the expense of the indemnifying
parties. Neither the indemnified party nor the indemnifying party shall settle or compromise any
Third Party Claim without the written consent of the other party, which consent will not be
unreasonably withheld, conditioned or delayed. No such consent will be required if the party
proposing such settlement (a)(A) agrees in writing to forego all claims for indemnification from
the indemnifying party with respect to such Third Party Claim or (B) reasonably believes itself to
be potentially or actually exposed to non-monetary remedies and (b) the settlement provides a
release of the other party with respect to all such Third Party Claims and does not contain any
allegations or statements that the other party or its Affiliates is culpable, liable or at fault.
(b) Procedures for Direct Claims. In the event any indemnified party should have a
claim against any indemnifying party under this Agreement that does not involve a Third Party
Claim being asserted against or sought to be collected from such indemnified party (a Direct
Claim), the indemnified party shall deliver notice of such Direct Claim with reasonable
promptness to the indemnifying party. The failure by any indemnified party to so notify the
indemnifying party hereunder shall not relieve the indemnifying party of its obligations hereunder
except to the extent that the indemnifying party is actually and materially prejudiced by such
failure. If the indemnifying party does not notify in writing the indemnified party within thirty
(30) calendar days that it disputes its liability to the indemnified party such Direct Claim
specified by the indemnified party in such notice shall be conclusively deemed a liability of the
indemnifying party and the indemnifying party shall pay the amount of such liability to the
indemnified party on demand or, in the case of any notice in which the amount of
the Direct Claim (or any portion thereof) is estimated, on such later date when the amount of
such Direct Claim (or such portion thereof) becomes finally determined.
10.5 Survival. The representations and warranties of the parties contained in this
Agreement or any certificate delivered in connection herewith shall survive the Closing for [***].
The agreements and covenants and other indemnification provisions of the parties contained in this
Agreement shall survive indefinitely, unless otherwise provided in this Agreement.
10.6 Tax Treatment. All payments made pursuant to this Article X shall be
treated to the extent permitted by applicable Law as adjustments to the Purchase Price for all Tax
purposes.
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10.7 Tax Refunds. The party bearing the liability or obligation to indemnify for any
Taxes shall be entitled to any refunds, credits or offsets of such Taxes. The Buyer shall promptly
forward to the Company, or after the Buyers receipt reimburse the Company, for any refunds or
credits due the Company (net of the cost to, or the Taxes imposed on, the Buyer with respect to the
receipt of such Tax refunds) pursuant to the terms of this Section 10.7, and the Company
shall promptly forward to the Buyer, or after the Companys receipt reimburse the Buyer, for any
refunds or credits due the Buyer pursuant to the terms of this Section 10.7.
10.8 Indemnification Not Affected by Investigation. The Company and the Transferring
Subsidiary hereby acknowledge and agree that any actual or constructive knowledge on the part of
the Buyer of any breach of any of the representations and warranties of the Company and the
Transferring Subsidiary contained in this Agreement to be true and correct shall in no way affect
or limit the applicability of the indemnification provisions contained in this Article X or
the ability of the Buyer and any of its Affiliates to seek any such indemnification against the
Company and the Transferring Subsidiary. The Buyer and the Intangibles Purchaser hereby
acknowledge and agree that any actual or constructive knowledge on the part of the Company of any
breach of any of the representations and warranties of the Buyer and the Intangibles Purchaser
contained in this Agreement to be true and correct shall in no way affect or limit the
applicability of the indemnification provisions contained in this Article X or the ability
of the Company and any of its Affiliates to seek any such indemnification against the Buyer and the
Intangibles Purchaser.
10.9 Insurance. Each indemnified party shall use reasonable efforts to collect any
amounts available under insurance coverage, or from any other Person alleged to be responsible, for
any Losses payable under this Article X. The amount of any Losses for which
indemnification is provided under this Agreement shall be net of any amounts actually recovered by
the indemnified party under insurance policies with respect to such Losses in excess of the sum of
(i) reasonable out-of-pocket costs and expenses relating to collection under such policies,
(ii) any deductible associated therewith to the extent paid and (iii) any corresponding
increase in insurance premiums or other chargebacks arising or resulting from or in respect of
insurance payments for the Losses.
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ARTICLE XI
MISCELLANEOUS
11.1 Notices. All notices and other communications hereunder shall be in writing and
shall be deemed duly given (a) on the date of delivery if delivered personally, or by telecopy or
facsimile, upon confirmation of receipt, (b) on the first Business Day following the date of
dispatch if delivered by a recognized next-day courier service or (c) on the fifth Business Day
following the date of mailing if delivered by registered or certified mail return receipt
requested, postage prepaid. All notices hereunder shall be delivered as set forth below, or
pursuant to such other instructions as may be designated in writing by the party to receive such
notice:
(i) if to the Company or the Transferring Subsidiary, to it at:
Nektar Therapeutics
201 Industrial Road
San Carlos, California 94070
Attention: Gil M. Labrucherie
Facsimile: +1 (650) 620-5360
with copies to:
OMelveny & Myers LLP
2765 Sand Hill Road
Menlo Park, California 94025
Attention: Sam Zucker
Facsimile: +1 (650) 473-2601
(ii) if to the Buyer or the Intangibles Purchaser, to it at:
Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, NJ 07936
Attention: General Counsel
Facsimile: +1 (973) 781-5260
with copies to:
Novartis Pharma AG
Lichtstrasse 35
CH-4056 Basel
Switzerland
Attention: General Counsel
Facsimile: +41 (61) 324-6859
Novartis International AG
Lichtstrasse 35
CH-4056 Basel
Switzerland
Attention: Joerg Walther
Facsimile: +41 (61) 324-7476
and
Kaye Scholer LLP
425 Park Avenue
New York, New York 10022
Attention: Adam Golden
Facsimile: +1 (212) 836-8689
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11.2 Counterparts; Facsimile Signature. This Agreement may be executed in any number
of counterparts, each of which shall be considered one and the same agreement and shall become
effective when all counterparts have been signed by each of the parties and delivered to the other
party, it being understood that the parties need not sign the same counterpart. Any party may
execute this Agreement by facsimile or scanned signature, and the other parties will be entitled to
rely on such facsimile or scanned signature as conclusive evidence that this Agreement has been
duly executed by such party.
11.3 Bulk Sales. The parties hereto agree to waive compliance with the provisions of
the Laws of any jurisdiction relating to a bulk sale or transfer of assets that may be applicable
to the transactions contemplated by this Agreement; provided, however, that to the
extent the Buyer or the Intangibles Purchaser is required to make any payments with respect to any
provisions of the Laws of any jurisdiction relating to a bulk sale that may be applicable to the
transactions contemplated by this Agreement, the Company shall indemnify the Buyer for such
payments pursuant to Section 10.1(a)(ii).
11.4 Further Assurances. From time to time after the Closing and without further
consideration, the parties hereto shall, and shall cause their respective Affiliates to, execute,
acknowledge and deliver such documents and instruments of conveyance, assignment, assumption,
transfer and delivery and take or cause to be taken such other actions as the Buyer or the Company,
as applicable, may reasonably request in order to carry out the purpose and intention of this
Agreement and the Transaction Documents, including to consummate more effectively the purchase,
sale, conveyance, assignment, assumption, transfer and delivery of the Transferred Assets as
contemplated by this Agreement, to vest in the Buyer or the Intangibles Purchaser title to the
Transferred Assets, to document and evidence the Companys or the Transferring Subsidiarys, as
applicable, continuing ownership or control of the Retained Assets, to evidence the assumption of
the Assumed Liabilities by the Buyer and the Intangibles Purchaser or as otherwise appropriate to
consummate the transactions contemplated by this Agreement and the Transaction Documents.
11.5 Entire Agreement. This Agreement and the agreements, documents, certificates and
instruments referred to herein or delivered pursuant hereto, including the Confidentiality
Agreement, the Exclusive License Agreement and the Service Agreements, constitute the entire
agreement among the parties hereto with respect to the subject matter hereof and terminate and
supersede all prior agreements and understandings, oral and written, among the parties hereto with
respect to the subject matter hereof and thereof.
11.6 No Third-Party Beneficiaries. This Agreement shall inure to the benefit of and
be binding upon the parties hereto and their respective successors and assigns. Nothing in this
Agreement (except as expressly set forth in Article X hereof), expressed or implied, is
intended to or shall confer on any Person other than the parties hereto or their respective
successors and assigns, any rights, remedies or Liabilities under or by reason of this Agreement.
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11.7 Assignment. Neither this Agreement nor any of the rights, interests or
obligations hereunder shall be assigned by any of the parties hereto, in whole or in part (whether
by operation of law or otherwise), without the prior written consent of the other parties, and any
attempt to make any such assignment without such consent shall be null and void; provided,
however, that the Buyer and/or the Intangibles Purchaser may assign in writing its rights
and obligations, in whole or in part, to one or more of its Affiliates, but the Buyer shall remain
jointly and severally liable with any such assignee(s) with respect to all obligations and
liabilities of the Buyer and/or the Intangibles Purchaser hereunder.
11.8 Amendment and Modification; Waiver. This Agreement may not be amended, modified
or supplemented, except by an instrument in writing signed on behalf of each of the parties hereto.
At any time prior to the Closing, the parties hereto may, to the extent legally permitted, (a)
extend the time for the performance of any of the obligations or other acts of any other party
hereto, (b) waive any inaccuracies in the representations and warranties
contained herein or in any document delivered hereto or (c) waive compliance with any of the
agreements or conditions contained herein. Any agreement by a party hereto to any such extension
or waiver shall be valid only if set forth in a written instrument signed on behalf of such party.
The failure of a party to assert any of its rights under this Agreement or otherwise shall not
constitute a waiver of those rights.
11.9 Enforcement; Jurisdiction. The parties agree that irreparable damage would occur
in the event that any of the provisions of this Agreement were not performed in accordance with
their specific terms or were otherwise breached. It is accordingly agreed that the parties shall
be entitled to an injunction or injunctions to prevent breaches of this Agreement and to enforce
specifically the terms and provisions of this Agreement in any federal court or state court sitting
in the State of New York, this being in addition to any other remedy to which they are entitled at
law or in equity subject to the terms hereof. In addition, each of the parties hereto (a) hereby
irrevocably agrees that any legal action or proceeding with respect to this Agreement or for
recognition and enforcement of any judgment in respect hereof brought by another party hereto or
its successors or assigns may be brought and determined in the federal courts located in the State
of New York, or, if such federal courts lack jurisdiction, in the state courts of the State of New
York located in Manhattan, and each party hereto hereby irrevocably submits with regard to any such
action or proceeding for itself and in respect of its property, generally and unconditionally, to
the exclusive jurisdiction of the aforesaid courts, and (b) irrevocably waives, and agrees not to
assert, by way of motion, as a defense, counterclaim or otherwise, in any action or proceeding with
respect to this Agreement, (i) any claim that it is not personally subject to the jurisdiction of
the above-named courts for any reason other than the failure to lawfully serve process, (ii) that
it or its property is exempt or immune from jurisdiction of any such court or from any legal
process commenced in such courts (whether through service of notice, attachment prior to judgment,
attachment in aid of execution of judgment, execution of judgment or otherwise), and (iii) to the
fullest extent permitted by applicable Law, that (A) the suit, action or proceeding in any such
court is brought in an inconvenient forum, (B) the venue of such suit, action or proceeding is
improper and (C) this Agreement, or the subject matter hereof, may not be enforced in or by such
courts.
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11.10 Waiver of Jury Trial. EACH OF THE PARTIES TO THIS AGREEMENT HEREBY IRREVOCABLY
WAIVES, TO THE FULLEST EXTENT PERMITTED BY LAW, ALL RIGHTS TO A TRIAL BY JURY IN ANY ACTION,
PROCEEDING OR COUNTERCLAIM (WHETHER BASED ON CONTRACT, TORT OR OTHERWISE) ARISING OUT OF OR
RELATING TO THIS AGREEMENT OR ANY OF THE TRANSACTIONS CONTEMPLATED HEREBY.
11.11 Costs and Expenses. Regardless of whether the transactions contemplated by this
Agreement are consummated and except as otherwise provided in this Agreement, the Company and the
Transferring Subsidiary, on the one hand, and the Buyer and the Intangibles
Purchaser, on the other hand, shall each bear their own costs and expenses (including
attorneys fees and costs) incurred in connection with this Agreement and the transactions
contemplated by this Agreement, except that fees relating to any filings pursuant to the HSR Act
and ARC shall be shared equally.
11.12 Mutual Drafting. The parties hereto have been represented by counsel who have
carefully negotiated the provisions hereof. As a consequence, the parties do not intend that the
presumptions of any laws or rules relating to the interpretation of contracts against the drafter
of any particular clause should be applied to this Agreement and therefore waive their effects.
The provisions of this Agreement shall be interpreted in a reasonable manner to effect the intent
of the parties.
11.13 Governing Law. This Agreement (and any claims or disputes arising out of or
related hereto or to the transactions contemplated hereby or to the inducement of any party to
enter herein, whether for breach of contract, tortious conduct or otherwise and whether predicated
on common law, statute or otherwise) shall in all respects be governed by, and construed in
accordance with, the laws of the State of New York, including all matters of construction, validity
and performance, in each case without reference to any conflict of law rules that might lead to the
application of the laws of any other jurisdiction.
11.14 Severability. Any term or provision of this Agreement which is invalid or
unenforceable in any jurisdiction shall, as to that jurisdiction, be ineffective to the extent of
such invalidity or unenforceability and shall not render invalid or unenforceable the remaining
terms and provisions of this Agreement or affect the validity or enforceability of any of the terms
or provisions of this Agreement in any other jurisdiction. If any provision of this Agreement is
so broad as to be unenforceable, the provision shall be interpreted to be only so broad as is
enforceable.
[Remainder of page intentionally left blank.]
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed and delivered
as of the date first above written.
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COMPANY
NEKTAR THERAPEUTICS
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/s/ Gil M. Labrucherie
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Name: |
Gil M. Labrucherie |
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Title: |
General Counsel |
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TRANSFERRING SUBSIDIARY
AEROGEN, INC.
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By: |
/s/ Gil M. Labrucherie
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Name: |
Gil M. Labrucherie |
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Title: |
Secretary |
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[SIGNATURE PAGE TO ASSET PURCHASE AGREEMENT]
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
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BUYER
NOVARTIS PHARMACEUTICALS CORPORATION
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By: |
/s/ Ludwig Hantson
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Name: |
Ludwig Hantson |
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Title: |
Chief Executive Officer |
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INTANGIBLES PURCHASER
NOVARTIS PHARMA AG
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By: |
/s/ Joseph Jimenez
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Name: |
Joseph Jimenez |
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Title: |
Chief Executive Officer |
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By: |
/s/ Jörg Walther
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Name: |
Jörg Walther |
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Title: |
Authorized Signatory |
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[SIGNATURE PAGE TO ASSET PURCHASE AGREEMENT]
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
SOLELY FOR THE PURPOSES OF
SECTION 5.15 AND ARTICLE XI HEREOF:
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NEKTAR UK
NEKTAR THERAPEUTICS UK LIMITED
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By: |
/s/ Gil M. Labrucherie
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Name: |
Gil M. Labrucherie |
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Title: |
Director |
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[SIGNATURE PAGE TO ASSET PURCHASE AGREEMENT]
Exhibit 10.17
Exhibit 10.17
NEKTAR THERAPEUTICS
AMENDED AND RESTATED CHANGE OF CONTROL
SEVERANCE BENEFIT PLAN
PLAN DOCUMENT AND SUMMARY PLAN DESCRIPTION
NEKTAR THERAPEUTICS
AMENDED AND RESTATED
CHANGE OF CONTROL SEVERANCE BENEFIT PLAN
PLAN DOCUMENT AND SUMMARY PLAN DESCRIPTION
Section 1. Introduction
The Nektar Therapeutics Amended and Restated Change of Control Severance Benefit Plan (the Plan)
is designed to provide severance benefits to eligible employees of Nektar Therapeutics (the
Company or Nektar) whose employment is involuntarily terminated by the Company following a
Change of Control (as defined below). The Plan was initially approved by the Board of Directors on
December 6, 2006 and subsequently amended and restated and approved by the Board of Directors on
February 14, 2007 and on October 21, 2008. The Plan supersedes any prior plan, policy or practice
involving the payment of severance benefits by Nektar in the event of an involuntary termination
that occurs in connection with or following a Change of Control. While the Plan is in effect, any
severance benefits provided to an employee by the Company with respect to an employees involuntary
termination in connection with or following a Change of Control must be paid pursuant to the Plan
or pursuant to an express written agreement between Nektar and the individual employee.
The Plan is designed to be an employee welfare benefit plan, as defined in Section 3(1) of the
Employee Retirement Income Security Act of 1974, as amended (ERISA) and, accordingly, this Plan
is governed by ERISA. This document constitutes both the official plan document and the required
summary plan description under ERISA.
Section 2. Eligibility For Participation in the Plan
Each employee of the Company is eligible to participate in the Plan; provided, however, that an
employee who has an individual agreement with the Company providing for severance benefits with
respect to termination of employment with the Company in connection with or following a Change of
Control that would otherwise be covered by this Plan shall not be eligible to participate in this
Plan (i.e. an eligible employee cannot receive severance benefits both under their individual
agreement and this Plan), and an individual who is not treated as an employee of the Company for
payroll and income tax withholding purposes or who is treated as a consultant or independent
contractor, regardless of a court or agencys determination of employee status of such person
during any period for any purpose, shall not be eligible to participate in this Plan.
Section 3. Eligibility For Severance Benefits
3.1 Conditions for Eligibility. To be eligible to receive severance benefits under the
Plan, in addition to meeting the requirements for eligibility to participate in the Plan, the
participant must terminate employment with the Company under circumstances that the Plan
Administrator determines constitute a Covered Termination, and the participant must meet the
following conditions:
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The participant must execute and deliver to the Company a Separation and General Release
Agreement in substantially the form attached hereto as Exhibit A and must not revoke
such agreement within any revocation period provided under applicable law. |
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If the participant is notified by the Company or Successor Company that his or her
employment will be terminated following a Change of Control in advance of his or her
termination date, the participant must not voluntarily terminate his or her employment or fail
to perform his or her assigned duties prior to the termination date established by the Company
or Successor Company. |
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The participant must not at any time have engaged in conduct that would be Cause for
termination, as defined in Section 3.3 below, as determined by the Plan Administrator in its
sole discretion. The Plan Administrator shall have the discretion to terminate any and all
severance benefits provided under this Plan to a participant who is discovered to have engaged
in such conduct, regardless of when such discovery occurs. |
3.2 Covered Termination. For purposes of this Plan, a Covered Termination is an
involuntary termination of the participants employment with the Company or Successor Company in
conjunction with a Change of Control under the circumstances described below applicable to the
participant, as follows:
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Officer Participants. For a participant who is an officer holding a position of
Executive Chairman, Chief Executive Officer, President, Chief Operating Officer, Business Unit
Head, Chief Scientific Officer, Chief Development Officer, Chief Technical Officer, Chief
Financial Officer, Senior Vice President, Vice President or Principal Fellow (an Officer
Participant), a Covered Termination is the involuntary termination of the participants
employment by the Company or Successor Company without Cause, other than on account of the
participants death or disability, or the participants Good Reason Resignation, which (i)
termination occurs at the request of a third party in the context of discussions regarding a
Change of Control or (ii) termination or resignation occurs within the period beginning with
the execution of an agreement providing for a Change of Control (and such Change of Control is
consummated) and ending 12 months following the Change of Control. |
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Non-Officer Participants. For any other participant (a Non-Officer Participant),
a Covered Termination is the involuntary termination of the participants employment by the
Company or Successor Company without Cause, other than on account of the participants death
or disability, which termination occurs within the period beginning on the date of the Change
of Control and ending 12 months following the Change of Control. |
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Termination of Employment Asset Sale. Notwithstanding anything else contained in
this Plan to the contrary, a participant shall not be entitled to benefits under this Plan as
a result of a termination of the participants employment with the Company or Successor
Company if such termination of employment occurs in connection with a sale of assets by the
Company or Successor Company and each of the following conditions is satisfied in connection
with such sale: (1) the participant becomes employed by the purchaser (which term shall
include
for these purposes a parent, subsidiary, or other affiliated entity of such purchaser) of such
assets upon or within sixty (60) days following such sale or such purchaser offers the
participant employment effective upon or within sixty (60) days following such sale (regardless
of whether the participant actually accepts or commences such employment) on substantially the
same terms; and (2) such purchaser adopts this Plan (or a substantially similar severance plan)
to provide the participant with substantially the same severance protections afforded by this
Plan had this Plan continued in effect as to the participant after such sale on its terms
(subject, without limitation, to any such entitys right to terminate this Plan as provided
herein). Whether employment is on substantially the same terms for this purpose shall be
determined by comparing the relevant aspects of the terms of the participants employment before
giving effect to such asset sale to the relevant aspects of the terms of the participants
employment (or offer of employment, as the case may be) with the purchaser after giving effect
to such asset sale (in each case relative to the Company and its subsidiaries, or the purchaser
and its parent, subsidiary, and other affiliated entities, as the case may be, on a consolidated
basis, not simply with reference to the participants employer). |
3.3 Cause. For purposes of this Plan, Cause shall mean, as determined by the Plan
Administrator:
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An employees conviction of any felony or any crime involving fraud, dishonesty or moral
turpitude; |
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An employees commission of, or participation in, a fraud or act of dishonesty against the
Company or Successor Company that materially benefits the employee; |
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An employees intentional, material violation of any contract or agreement between the
employee and the Company or Successor Company or of any statutory or fiduciary duty owed to
the Company or Successor Company; |
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An employees intentional unauthorized use of Company or Successor Company property that
materially benefits the employee or intentional unauthorized use or disclosure of Company or
Successor Company confidential information or trade secrets; |
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An employees intentional gross misconduct or intentional material failure to comply with
the Companys or Successor Companys written policies; or |
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An employees intentional material failure or refusal to perform his or her position
responsibilities, other than on account of a mental or physical disability. |
No act or failure to act on the part of an individual shall be considered intentional unless
done, or omitted to be done, by that individual not in good faith and without reasonable belief
that such individuals action or omission was in the best interest of the Company. In no event
shall mere failure to achieve desired strategic, operational, financial or other results constitute
Cause.
3
3.4 Good Reason Resignation. For purposes of this Plan, an Officer Participants Good
Reason Resignation shall mean a voluntary resignation by the Officer Participant following the
occurrence of any of the following conditions without the Officer Participants express written
consent:
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Assignment of any authority, duties or responsibilities that results in a material
diminution in the participants authority, duties or responsibilities as in effect immediately
prior to the Change of Control. |
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Assignment to a work location more than 50 miles from the participants immediately
previous work location, unless such reassignment of work location decreases the participants
commuting distance from his or her residence to his or her assigned work location. |
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A material diminution in the participants monthly base salary as in effect on the date of
the Change of Control or as increased thereafter. |
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Notice to the participant by the Company or Successor Company during the 12-month period
following the Change of Control that the participants employment will be terminated under
circumstances that would be a Covered Termination but for the designation of a date for
termination that is greater than 12 months following the Change of Control (provided that such
participant does in fact terminate his or her employment within the time period prescribed
below). |
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In the case of the Chief Executive Officer and President, such individual does not serve in
that position in the Successor Company (as defined below) and/or is not appointed to the board
of directors of the Successor Company. |
provided, however, that any such condition shall not constitute grounds for a Good Reason
Resignation unless both (x) the Officer Participant provides written notice to the Company of the
condition claimed to constitute grounds for the Good Reason Resignation within sixty (60) days of
the initial existence of such condition, and (y) the Company fails to remedy such condition within
thirty (30) days of receiving such written notice thereof; and provided, further, that in all
events the termination of the Officer Participants employment with the Company shall not be
treated as a Good Reason Resignation unless such termination occurs not more than six (6) months
following the initial existence of the condition claimed to constitute Good Reason.
3.5 Change of Control. A Change of Control with respect to the Company shall mean any of
the following events or circumstances:
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The sale, lease or other disposition of all or substantially all of the Companys assets; |
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The acquisition of securities of the Company representing more than 50% of the combined
voting power of the Companys then outstanding securities, other than by virtue of a merger,
consolidation or similar transaction; |
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The merger, consolidation or similar transaction involving the Company, immediately after
which the stockholders of the Company immediately prior thereto do not own either
(i) outstanding voting securities representing more than 50% of the combined outstanding
voting power of the surviving entity in such merger, consolidation or similar transaction or
(ii) more than 50% of the combined outstanding voting power of the parent of the surviving
entity in such merger, consolidation or similar transaction, in each case in substantially the
same proportions as their ownership of the outstanding voting securities of the Company
immediately prior to such transaction; or |
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Individuals who, on the date the Plan is adopted by the Board, are members of the Board
(the Incumbent Board) cease for any reason to constitute at least a majority of the members
of the Board, provided, however, that if the appointment or election of any new Board member
was approved or recommended by a majority vote of the members of the Incumbent Board then
still in office, such new member will, for purposes of the Plan, be considered as a member of
the Incumbent Board. |
In the event of a Change of Control following which Nektar is not the surviving entity, the
surviving entity for purposes of this Plan is the Successor Company.
Section 4. Severance Benefits
A participant who is eligible to participate in this Plan in accordance with Section 2 and who
becomes eligible to receive severance benefits under this Plan as determined under Section 3 shall
be entitled to receive, subject to the terms and conditions herein, the following severance
benefits set forth in this Section 4:
4.1 Cash Severance Pay; Amount. The amount of a participants Cash Severance Pay benefit
under this Plan shall be determined based on position title as follows, and then reduced as
specified below:
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Executive Chairman: Cash Severance Pay shall equal 24 months of monthly base salary plus
annual target incentive pay as in effect immediately prior to the Covered Termination or for
the immediately preceding calendar year, whichever is greater. |
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Chief Executive Officer and President: Cash Severance Pay shall equal 24 months of monthly
base salary plus annual target incentive pay as in effect immediately prior to the Covered
Termination or for the immediately preceding calendar year, whichever is greater. |
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Chief Scientific Officer, Chief Development Officer, Chief Financial Officer, Chief
Technical Officer, Chief Operating Officer and Business Unit Head: Cash Severance Pay shall
equal 12 months of monthly base salary plus annual target incentive pay as in effect
immediately prior to the Covered Termination or for the immediately preceding calendar year,
whichever is greater. |
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Senior Vice Presidents, Vice Presidents and Principal Fellows: Cash Severance Pay shall
equal 12 months of monthly base salary plus annual target incentive pay as in effect
immediately prior to the Covered Termination or for the immediately preceding calendar year,
whichever is greater. |
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All Other Participants: Cash Severance Pay shall equal 6 months of monthly base salary
plus annual target incentive pay as in effect immediately prior to the Covered Termination or
for the immediately preceding calendar year, whichever is greater. |
Cash Severance Pay shall be reduced by each of the following:
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any severance benefits (including, without limitation, any other change-in-control
severance benefits and any other severance benefits generally) that the participant may be
entitled to under any other plan or program with the Company. For purposes of the foregoing,
any cash severance benefits payable to the participant under any other plan or program with
the Company (including, without limitation, the Companys Severance Benefit Plan or any
similar successor plan) shall offset the Cash Severance Pay otherwise payable to the
participant under this Plan on a dollar-for-dollar basis. For purposes of the foregoing,
non-cash severance benefits to be provided to the participant under any other plan or program
with the Company shall offset any corresponding benefits otherwise to be provided to the
participant under this Plan or, if there are no corresponding benefits otherwise to be
provided to the participant under this Plan, the value of such benefits shall offset the cash
severance benefits otherwise payable to the participant under this Plan on a dollar-for-dollar
basis. If the amount of other benefits to be offset against the Cash Severance Pay otherwise
payable to the participant under this Plan in accordance with the preceding two sentences
exceeds the amount of Cash Severance Pay otherwise payable to the participant under this Plan,
then the excess may be used to offset other non-cash severance benefits otherwise to be
provided to the participant under this Plan on a dollar-for-dollar basis. For purposes of
this paragraph, the Plan Administrator shall reasonably determine the value of any non-cash
benefits; |
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any wages or wage replacement benefits paid or payable to the participant with respect to
any applicable notice period (including any pay in lieu of notice) in connection with the
participants termination of employment, whether such notice period is required under the
Worker Adjustment and Retraining Notification Act or any state law with respect to notice, if
applicable, or any Company policy, or any written agreement between the participant and the
Company; |
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the amount of any wages or other compensation the participant has received during a leave
of absence in excess of his or her accrued paid time off (other than disability plan income
replacement benefits); and |
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to the extent permitted by law, by any debt that the participant owes the Company at the
time the Cash Severance Pay becomes payable. |
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4.2 Cash Severance Pay: Time of Payment. The Cash Severance Pay for which a participant is
eligible under this Plan will be paid to the participant in a lump sum cash payment no later than
sixty (60) days following the date on which the participants Separation from Service (as defined
below) occurs, subject to the provisions of Section 3.1. Notwithstanding the foregoing sentence or
any other provision of this Plan to the contrary, if the participant is an Officer Participant or
is otherwise a specified employee within the meaning of Treasury Regulation Section 1.409A-1(i)
as of the date of the participants Separation from Service, the participant shall not be entitled
to any payment of Cash Severance Pay until the earlier of (i) the date which is six (6) months
after the participants Separation from Service for any reason other than death, or (ii) the date
of the participants death. Any amounts otherwise payable to the participant upon or in the six
(6) month period following the participants Separation from Service that are not so paid by reason
of this paragraph shall be paid (without interest) as soon as practicable (and in all events within
thirty (30) days) after the date that is six (6) months after the participants Separation from
Service (or, if earlier, as soon as practicable, and in all events within thirty (30) days, after
the date of the participants death). The provisions of this paragraph shall only apply if, and to
the extent, required to avoid the imputation of any tax, penalty or interest pursuant to Section
409A of the U.S. Internal Revenue Code of 1986, as amended (the Code).
As used herein, a participants Separation from Service occurs when the participant dies,
retires, or otherwise has a termination of employment with the Company that constitutes a
separation from service within the meaning of Treasury Regulation Section 1.409A-1(h)(1), without
regard to the optional alternative definitions available thereunder.
4.3 COBRA Premiums. For an eligible participant who is covered by one or more of the
Companys group health plans on the date of termination of employment and who makes a timely
election to continue such coverage under the Consolidated Omnibus Budget Reconciliation Act
(COBRA), the Company will pay the portion of such participants COBRA premium equal to the
portion of such group health plan premium cost the Company pays for active employees for the number
of months base salary represented by the participants Cash Severance Pay determined under Section
4.1; provided that such payment of a portion of the COBRA premium by the Company shall cease
earlier on the date the participant becomes eligible for group medical, dental or vision coverage
through a subsequent employer. To the extent that the payment of any COBRA premiums pursuant to
this Section 4.3 is taxable to the participant, any such payment shall be paid to the participant
on or before the last day of the participants taxable year following the taxable year in which the
related expense was incurred. The participants right to payment of such premiums is not subject
to liquidation or exchange for another benefit and the amount of such benefits that the participant
receives in one taxable year shall not affect the amount of such benefits that the participant
receives in any other taxable year.
4.4 Outplacement Program. An eligible participant shall receive reimbursement for
reasonable outplacement services up to a maximum of $5,000 for services received within 12 months
following termination, any such reimbursement to be made in accordance with the Companys
reimbursement policies generally and in all events not later than the end of the calendar year
following the year in which the related expense was incurred. The participants right to benefits
under this Section 4.4 is not subject to liquidation or exchange for another
benefit and the amount of such benefits that the participant receives in one taxable year shall not
affect the amount of such benefits that the participant receives in any other taxable year.
7
4.5 Withholding. All cash and reimbursement severance benefits provided under the Plan will
be subject to all applicable withholding deductions as required by law.
4.6 Equity Acceleration. An eligible participant will become fully vested in any
outstanding stock awards held by such participant as of the date of termination, including
restricted stock and stock options.
4.7 Limitation on Benefits Subject to Parachute Rules. Notwithstanding Section 4.1 and
4.6, in the event the severance benefits payable hereunder to a participant who is a disqualified
individual within the meaning of Code Section 280G, together with all other payments to which such
participant is entitled in connection with a Change of Control (collectively, the Payments),
would cause any portion of the Payments to be nondeductible under Code Section 280G and subject to
the excise tax imposed under Code Section 4999 (the Excise Tax), then the following rules shall
apply:
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If a reduction in the amount of the Payments by an amount up to but not in excess of ten
percent (10%) of the amount of the Payments would avoid the imputation of any Excise Tax on
the remaining Payments (after such reduction), then the Payments shall be reduced (but not
below zero) if and to the extent that such a reduction in the Payments would result in the
participant retaining a larger amount, on an after-tax basis (taking into account federal,
state and local income taxes and the Excise Tax), than if the participant received the entire
amount of the Payments. The Company shall reduce or eliminate the Payments by first reducing
or eliminating any Cash Severance Pay, then by reducing or eliminating any accelerated vesting
of equity awards, then by reducing or eliminating any other remaining Payments. |
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If a reduction in the amount of the Payments by 10% of the amount of the Payments would not
avoid the imputation of any Excise Tax on the remaining Payments (after such reduction), then
the Company shall pay to the participant (or to the applicable taxing authority on
participants behalf) an additional cash payment (the Gross-Up Payment) equal to an amount
such that after payment by the participant of all taxes, interest, penalties, additions to tax
and costs imposed or incurred with respect to the Gross-Up Payment (including, without
limitation, any income and excise taxes imposed upon the Gross-Up Payment), the participant
retains an amount of the Gross-Up Payment equal to the Excise Tax imposed upon such Payment or
Payments. The Gross-Up Payment, if triggered pursuant to this Section 4.7(ii), is intended to
put the participant in the same position as the participant would have been had no Excise Tax
been imposed upon or incurred as a result of any Payment. Any such Gross-Up Payment shall be
paid as soon as practicable and in all events no later than the end of the calendar year
following the year in which the participant remits the related taxes. |
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Section 5. Notices
Any notice or other communication under the Plan must be in writing and will be deemed given when
delivered personally or when sent by certified or registered mail, return receipt requested, or by
overnight courier, addressed as follows or to such other address as any party may hereafter
designate in accordance with this provision:
If to Nektar or the Plan Administrator:
Nektar Therapuetics
150 Industrial Road
San Carlos, CA 94070
Attn: Vice President, Human Resources
If to the participant: to the address appearing in the payroll records of the Company.
Section 6. Claims
6.1 Initial Claims Procedure. Any employee who does not receive a benefit under the Plan
that he or she feels he or she is entitled to receive may make a written claim to the Plan
Administrator within 90 days after his or her termination, in accordance with the Notice provisions
described above, and which explains the reasons for such claim. The claimant will be informed of
the Plan Administrators decision with respect to the claim within 90 days after it is filed.
Under special circumstances, the Plan Administrator may require an additional period of not more
than 90 days to review the claim. If that happens, the claimant will receive a written notice of
that fact, which will also indicate the special circumstances requiring the extension of time and
the date by which the Plan Administrator expects to make a determination with respect to the claim.
If the extension is required due to the claimants failure to submit information necessary to
decide the claim, the period for making the determination will be tolled from the date on which the
extension notice is sent until the date on which the claimant responds to the Plan Administrators
request for information.
6.2 Notice of Claim Determination. If a claim is denied in whole or in part, or any
adverse benefit determination is made with respect to the claim, the claimant will be provided with
a written notice setting forth the reason for the determination, along with specific references to
Plan provisions on which the determination is based. This notice will also provide an explanation
of what additional information is needed to evaluate the claim (and why such information is
necessary), together with an explanation of the Plans claims review procedure and the time limits
applicable to such procedure, as well as a statement of the claimants right to bring a civil
action under Section 502(a) of ERISA following an adverse benefit determination on review. If an
internal rule, guideline, protocol, or other similar criterion was relied upon in making the
determination, the notice will either provide that rule, guideline, protocol or other similar
criterion or will contain a statement that it will be provided upon request.
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6.3 Claims Appeal Procedure. If the claim has been denied, and the claimant wishes to
pursue the claim further, the claimant must request that the Plan Administrator review the denial.
The request must be in writing and must be made within 60 days after written notification of
denial. In connection with this request, the claimant may review documents pertinent to the claim
(other than those that are legally privileged) and may submit to the Plan Administrator written
comments, documents, records, and other information related to the claim.
The review by the Plan Administrator will take into account all comments, documents, records, and
other information that the claimant submits relating to the claim. The Plan Administrator will
make a final written decision on a claim review, in most cases within 60 days after receipt of a
request for a review. In some cases, the claim may take more time to review, and an additional
processing period of up to 60 days may be required. If that happens, the claimant will receive a
written notice of that fact, which will also indicate the special circumstances requiring the
extension of time and the date by which the Plan Administrator expects to make a determination with
respect to the claim. If the extension is required due to the claimants failure to submit
information necessary to decide the claim, the period for making the determination will be tolled
from the date on which the extension notice is sent to the claimant until the date on which the
claimant responds to the Plans request for information.
6.4 Notice of Appeal Determination. The Plan Administrators decision on the claim for
review will be communicated to the claimant in writing. If an adverse benefit determination is
made with respect to the claim, the notice will include (i) the specific reason(s) for any adverse
benefit determination, with references to the specific Plan provisions on which the determination
is based; (ii) a statement that the claimant is entitled to receive, upon request and free of
charge, reasonable access to (and copies of) all documents, records and other information relevant
to the claim (other than those that are legally privileged); and (iii) a statement of the
claimants right to bring a civil action under Section 502(a) of ERISA. If an internal rule,
guideline, protocol, or other similar criterion was relied upon in making the determination, the
notice will either provide that rule, guideline, protocol or other similar criterion or will
contain a statement that it will be provided upon request. The decision of Plan Administrator is
final and binding on all parties.
6.5 Requirement to Follow Claims Procedures. If a claimant does not file his or her claim
in accordance with the Plans claim procedures described above, including applicable time limits,
the claimant will not be entitled to benefits under this Plan.
6.6 Limitation on Legal Action. No legal action with respect to this Plan may be brought
until a claimant has exhausted the claims procedures described above, including the claims appeal
procedure. No legal action for coverage or benefits under the Plan may be commenced or maintained
more than 2 years after the circumstances giving rise to the claim arose or, if earlier, 1 year
after the claims procedures, including the claims appeal procedure, is exhausted.
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Section 7. Plan Amendment and Termination
The Company reserves the right to amend or modify the Plan at any time, and in any respect, by
action of its duly authorized officer, with or without prior notice to, and effective with respect
to, employees who may become eligible to participate in the Plan or become eligible for benefits
under the Plan in the case of a reduction in benefits payable under the Plan, or who may otherwise
have become eligible to participate in the Plan in the case of an amendment that excludes such
employees from eligibility to participate under the Plan. However, no such amendment or
termination will be effective to: (i) decrease benefits under the Plan for which an employee has
already met all of the eligibility criteria and payment conditions set forth herein or (ii)
negatively or adversely impact the rights of the Chief Executive Officer and President hereunder
without the written consent of the Chief Executive Officer and President.
Section 8. Legal Rights Under ERISA
An employee covered under the Plan is entitled to certain rights and protections under the Employee
Retirement Income Security Act of 1974, as amended (ERISA). ERISA provides that you are entitled
to:
Receive Information About Your Plan and Benefits
Examine, without charge, at the Plan Administrators office and at other specified
locations, such as worksites, all documents governing the Plan, including a copy of the
latest annual report (Form 5500 Series), if any, filed by the Plan with the U.S. Department
of Labor and available at the Public Disclosure Room of the Employee Benefits Security
Administration.
Obtain, upon written request to the Plan Administrator, copies of documents governing the
operation of the Plan, including copies of the latest annual report (Form 5500 Series), if
any, and updated summary plan description. The Plan Administrator may make a reasonable
charge for the copies.
Receive a summary of the Plans annual financial report (if any). The Plan Administrator is
required by law to furnish each participant with a copy of this summary annual report.
Prudent Actions by Plan Fiduciaries
In addition to creating rights for Plan participants, ERISA imposes duties upon the people
who are responsible for the operation of the Plan. The people who operate the Plan, called
fiduciaries of the Plan, have a duty to do so prudently and in the interest of the Plan
participants and beneficiaries. No one, including the employer or any other person, may
fire an employee or otherwise discriminate against an employee in any way to prevent such
employee from obtaining a welfare benefit or exercising such employees rights under ERISA.
11
Enforce Rights
If a claim for a welfare benefit is denied or ignored, in whole or in part, the claimant has
a right to know why this was done, to obtain copies of documents relating to the decision
without charge, and to appeal any denial, all within certain time schedules.
Under ERISA, there are steps an employee can take to enforce the above rights. For
instance, if an employee makes a written request for a copy of Plan documents or the latest
annual report from the Plan Administrator and does not receive them within 30 days, the
employee may file suit in a Federal court. In such a case, the court may require the Plan
Administrator to provide materials and pay the employee up to $110 a day until the employee
receives the materials, unless the materials were not sent because of reasons beyond the
control of the Plan Administrator.
If an employee has a claim for benefits that is denied or ignored, in whole or in part, the
employee may file suit in a state or Federal court. If it should happen that Plan
fiduciaries misuse the Plans money or if an employee is discriminated against for asserting
his or her rights, such employee may seek assistance from the U.S. Department of Labor, or
such employee may file suit in a Federal court. The court will decide who should pay court
costs and legal fees. If the employee is successful, the court may order the person sued to
pay these costs and fees. If the employee loses, the court may order the employee to pay
these costs and fees, for example, if it finds the employees claim is frivolous.
An employee who has any questions about the Plan should contact the Plan Administrator. An
employee who has any questions about this statement or his or her rights under ERISA should contact
the nearest office of the Employee Benefits Security Administration, U.S. Department of Labor,
listed in the telephone directory, or the Division of Technical Assistance and Inquiries, Employee
Benefits Security Administration, U.S. Department of Labor, 200 Constitution Avenue, N.W.,
Washington, D.C. 20210.
Section 9. Other Important Information
9.1 No Additional Rights Created. Neither the establishment of this Plan, nor any
modification thereof, nor the payment of any benefits hereunder, shall be construed as giving to
any individual (or any beneficiary of either), or other person any legal or equitable right against
the Company, or any of its affiliates, or any officer, director or employee thereof; and in no
event shall the terms and conditions of employment by the Company (or any affiliate) of any
individual be modified or in any way affected by this Plan.
9.2 Records. The records of the Company with respect to the determination of Eligible
Years of Service, employment history, Base Pay, absences, and all other relevant matters shall be
conclusive for all purposes of this Plan.
12
9.3 Construction. The Plan is intended to be governed by ERISA. The respective terms and
provisions of the Plan shall be construed, whenever possible and for all purposes, to be in
conformity with the requirements of ERISA, or any subsequent laws or amendments thereto. To the
extent not in conflict with ERISA or the terms of the Plan, the construction and administration of
the Plan shall be in accordance with applicable federal law and the laws of the State of California
applicable to contracts made and to be performed within the State of California (without
application of California conflict of laws provisions). The Plan is intended to comply with
Section 409A of the Code (including the Treasury regulations and other published guidance relating
thereto) so as not to subject any participant to payment of any interest or additional tax imposed
under Code Section 409A. The provisions of the Plan shall be construed and interpreted to avoid
the imputation of any such additional tax, penalty or interest under Code Section 409A yet preserve
(to the nearest extent reasonably possible) the intended benefit payable to the participant.
9.4 Nontransferability of Benefits Rights. In no event shall the Company make any payment
under this Plan to any assignee or creditor of an employee, except as otherwise required by law.
Prior to the time of a payment hereunder, an employee shall have no rights by way of anticipation
or otherwise to assign or otherwise dispose of any interest under this Plan, nor shall rights be
assigned or transferred by operation of law.
9.5 Plan Interpretation and Benefit Determination. The Plan is administered and operated
by the Plan Administrator, which has complete authority, in such person or entitys sole and
absolute discretion, to construe and interpret the terms of the Plan (and any related or underlying
documents or policies), and to determine the eligibility for, and amount of, benefits due under the
Plan. All such interpretations and determinations of the Plan Administrator shall be final and
binding upon all parties and persons affected thereby. The Plan Administrator may appoint one or
more individuals and delegate such of its powers and duties with respect to this Plan as it deems
desirable to any such individual(s), in which case every reference herein made to the Plan
Administrator shall be deemed to mean or include the appointed individual(s) as to matters within
their jurisdiction as delegated by the Plan Administrator. The discretion and authority of the
Plan Administrator under this Section 9.5 is subject to the notice, claims and appeals procedures
set forth in Section 6.
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Section 10. Important Plan Information
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Sponsors Name and Address:
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Nektar Therapeutics
150 Industrial Road
San Carlos, CA 94070
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Plan Number:
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503 |
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Employer Identification Number:
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94-3134940 |
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Plan Administrator:
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Nektar Therapeutics
150 Industrial Road
San Carlos, CA 94070
Tel: 650-631-3100 |
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The Plan Administrator has delegated day-to-day |
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administration of the Plan to the following person: |
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Vice President, Human Resources |
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Agent to Receive Process:
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Nektar Therapeutics
150 Industrial Road
San Carlos, CA 94070
Attn: General Counsel |
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Type of Plan:
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The Plan is an unfunded employee welfare benefit plan. Benefits under the Plan are paid from the
general assets of Nektar Therapeutics. Benefits under the Plan are not insured by the Pension
Benefit Guaranty Corporation. |
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Effective Date:
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January 1, 2007 |
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Plan Year:
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The calendar year, from January 1 to December 31. |
14
EXHIBIT A
FORM OF SEPARATION AND GENERAL RELEASE AGREEMENT
This Separation and General Release Agreement (this Agreement) is entered into this
day of
20 ,
by and between , an individual (Employee),
and Nektar Therapeutics, a Delaware corporation (the Company).
WHEREAS, Employee has been employed by the Company or one of its subsidiaries; and
WHEREAS, Employees employment by the Company or one of its subsidiaries has terminated and,
in connection with the Companys Amended and Restated Change in Control Severance Plan (the
Plan), the Company and Employee desire to enter into this Agreement upon the terms set
forth herein;
NOW, THEREFORE, in consideration of the covenants undertaken and the releases contained in
this Agreement, and in consideration of the Companys (or one of its subsidiaries) obligation to
pay severance benefits (conditioned upon this release) under and pursuant to the Plan, Employee and
the Company agree as follows:
1. Separation Date. Your last day of work is [ , 20 ] (the Separation Date).
2. Accrued Salary and Paid Time Off.
(a) Accrued Salary. The Company will pay you on the Separation Date all accrued and unpaid
salary through the Separation Date subject to applicable payroll deduction and withholding.
(b) Accrued Paid Time Off. The Company will pay you any accrued and unused paid time off
earned by you through the Separation Date, subject to applicable payroll deduction and withholding.
In the event you have negative paid time off balance, such amount will be deducted from your
Severance (as defined below) as provided in Section 6(a).
3. Incentive Compensation. You will be eligible for payments under the Companys
Discretionary Performance-Based Incentive Compensation Policy (Bonus Plan) if the Company
meets its corporate objectives and goals under the Bonus Plan for the six-month performance period
that ended on [
, 20 ]. Your bonus payment (if any) will be based on the Companys
corporate performance percentage rating such six-month performance period and your managers rating
of your individual performance, and will be paid to you at approximately the same time payments are
made to the Companys employees under the Bonus Plan for such period. The foregoing payments (if
any) are subject to standard payroll deductions and withholdings.
1.
4. Payment in Full. You acknowledge and agree that you have received all salary, wages,
accrued vacation, bonuses, commissions, expense reimbursements, or other such sums due to you other
than the severance benefits to be paid or provided to you pursuant to the Plan.
In light of the payment by Company of all wages due, you and the Company further acknowledge
and agree that California Labor Code § 206.5 is not applicable. That section provides in pertinent
part as follows:
No employer shall require the execution of any release of any claim or
right on account of wages due, or to become due, or made as an event
on wages to be earned, unless payment of such wages has been made.
5. Non-Disparagement. Both you and the Company (through its officers and directors) agree not
to disparage the other party, and the other partys officers, directors, employees, shareholders
and agents, in any manner likely to be harmful to them or their business, business reputation or
personal reputation; provided that both you and the Company shall respond accurately and fully to
any question, inquiry or request for information when required by legal process.
6. Confidentiality. The provisions of this Agreement shall be held in strictest confidence by
you and the Company and shall not be publicized or disclosed in any manner whatsoever; provided,
however, that: (a) you may disclose this Agreement to your immediate family; (b) the parties may
disclose this Agreement in confidence to their respective attorneys, accountants, auditors, tax
preparers, and financial advisors; (c) the Company may disclose this Agreement as necessary to
fulfill standard or legally required corporate reporting or disclosure requirements; and (d) the
parties may disclose this Agreement insofar as such disclosure may be necessary to enforce its
terms or as otherwise required by law.
7. Expense Reimbursements. You agree that, within ten (10) business days following the
Separation Date, you will submit your final documented expense reimbursement statement reflecting
all business expenses you incurred through the Separation Date, if any, for which you seek
reimbursement. The Company will reimburse you for these expenses pursuant to its regular business
practice.
8. Return of Company Property. You agree that, on the Separation Date, you shall return to
the Company all Company documents (and all copies thereof) and other Company property in your
possession or control, including, but not limited to: Company files, email, notes, memoranda,
correspondence, agreements, draft documents, notebooks, logs, drawings, records, plans, proposals,
reports, forecasts, financial information, sales and marketing information, research and
development information, personnel information, specifications, computer-recorded information,
tangible property and equipment, cell phones, pagers, PDAs (e.g., Blackberrys), credit cards, entry
cards, identification badges and keys; and any materials of any kind that contain or embody any
proprietary or confidential information of the Company (and all reproductions thereof in whole or
in part). If you have used any personal computer, server, or e-mail system to receive, store,
review, prepare or transmit any Company confidential or proprietary data, materials or information,
you agree to provide the Company with a computer-useable copy of such information and then
permanently delete and expunge such Company confidential or proprietary information from those
systems; and you agree to provide the Company access to your system as requested to verify that the
necessary copying and/or deletion is done. YOU AGREE NOT TO RETAIN ANY PAPER OR ELECTRONIC COPIES
OF ANY COMPANY DOCUMENTS OR DATA (INCLUDING BUT NOT LIMITED TO EMAIL) OTHER THAN THIS
AGREEMENT AND OTHER DOCUMENTS EVIDENCING YOUR EMPLOYMENT RELATIONSHIP WITH THE COMPANY. YOU WILL
NOT BE ENTITLED TO ANY SEVERANCE BENEFITS UNLESS AND UNTIL YOU COMPLY FULLY WITH THE TERMS SET
FORTH IN THIS PARAGRAPH.
2.
9. Employment Agreement Continues. Following the Separation Date, you have continuing
obligations under your Employee Agreement with the Company which include, among other obligations,
not to use or disclose any confidential or proprietary information of the Company.
10. Non-Solicitation. You agree that, for twelve (12) months following the Separation Date,
you shall not, directly or indirectly (e.g. through directing a recruiting firm to target Company
employees), without prior written consent of the Company, solicit or induce any employee of the
Company to leave the employ of the Company.
11. General Release. Except as otherwise stated in this Agreement, and in exchange for the
consideration given under the Plan, you hereby generally and completely release the Company and its
subsidiaries, successors, predecessors and affiliates, and its and their respective partners,
members, directors, officers, employees, stockholders, shareholders, agents, attorneys,
predecessors, insurers, affiliates and assigns, from any and all claims, liabilities and
obligations, both known and unknown, that arise out of or are in any way related to events, acts,
conduct, or omissions occurring at any time prior to and including the date you sign this
Agreement. This general release includes, but is not limited to:
(a) all claims arising out of or in any way related to your employment with the Company or the
termination of that employment;
(b) all claims related to your compensation or benefits, including salary, bonuses,
commissions, vacation pay, expense reimbursements, severance pay, fringe benefits, stock, stock
options, restricted stock units, or any other ownership interests in the Company;
(c) all claims for breach of contract, wrongful termination, and breach of the implied
covenant of good faith and fair dealing;
(d) all tort claims, including claims for fraud, defamation, emotional distress, and discharge
in violation of public policy; and
(e) all federal, state, and local statutory claims, including claims for discrimination,
harassment, retaliation, attorneys fees, or other claims arising under the federal Civil Rights
Act of 1964 (as amended), the federal Americans with Disabilities Act of 1990 (as amended), the
federal Age Discrimination in Employment Act (as amended) (ADEA), the federal Employee
Retirement Income Security Act of 1974 (as amended), and the California Fair Employment and Housing
Act (as amended).
3.
You represent that you have no lawsuits, claims or actions pending in your name, or on behalf of
any other person or entity, against the Company or any other person or entity subject to the
release granted in this paragraph.
Notwithstanding the release of claims otherwise provided for in this Section of the Agreement, it
is expressly understood that nothing in this Agreement will prevent you from filing a charge of
discrimination with the Equal Employment Opportunity Commission or any of its state or local
deferral agencies, or participating in any investigation by the Equal Employment Opportunity
Commission or any of its state or local deferral agencies, although you understand that by signing
this Agreement, you waive the right to recover any damages or to receive other relief in any claim
or suit brought by or through the Equal Employment Opportunity Commission or any other state or
local deferral agency on your behalf. Further, it is expressly understood that nothing in this
Agreement shall be construed to be a waiver by you of any benefit that vested in any benefit plan
prior to his termination date or as a waiver of his right to continue any benefit in accordance
with the terms of a benefit plan. Likewise nothing in this Agreement shall be construed to waive
any right that is not subject to waiver by private agreement, including any right that you may have
under California Labor Code Section 2802 to indemnification of any expenses or losses incurred in
discharging your duties. It is also expressly understood that nothing in this Agreement shall in
any way prohibit you from bringing any complaint, claim or action seeking to challenge the validity
of this Agreement and/or bringing any complaint claim or action alleging a breach of this Agreement
by the Company.
12. [ADEA Waiver.1 You acknowledge that your waiver and release of any rights you
may have under ADEA is knowing and voluntary, and that the consideration given under the Plan
(severance, COBRA payments, outplacement), in exchange for your general waiver and release, is in
addition to anything of value to which you were already entitled. You are hereby advised that:
(a) your waiver and release do not apply to any rights or claims that may arise after the date
you sign this Agreement;
(b) prior to signing this Agreement you should consult with an attorney (although you may
choose voluntarily not to do so);
(c) you have [twenty-one (21)/forty-five (45)] days to consider this Agreement (although you
may choose voluntarily to sign it earlier);
(d) you have seven (7) days following the date you sign this Agreement to revoke it by
providing written notice to the Companys General Counsel;
(e) this Agreement shall not be effective until the revocation period expires which will be
the eighth day after you sign this Agreement;
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Section 12 will be included if the Employee is age 40
or older as of the date that the Employees employment with the Company
terminates or in such other circumstances (if any) as the Employee may have
claims under the ADEA. In the event Section 12 is included, whether the
Employee has 21 days, 45 days, or some other period in which to consider the
Release Agreement will be determined with reference to the requirements of the
ADEA in order for such waiver to be valid in the circumstances. The
determinations referred to in the preceding two sentences shall be made by the
Company in its sole discretion. |
4.
(f) nothing in this Agreement prevents or precludes you from challenging or seeking a
determination in good faith of the validity of this waiver under the ADEA, nor does it
impose any condition precedent, penalties or costs for doing so, unless specifically
authorized by federal law; and
(g) in order to revoke this Agreement, you must deliver to Gil Labrucheries attention at the
following address a written revocation before 12:00 a.m. (midnight) p.s.t. on the seventh calendar
day following the date you sign the Agreement:
Gil M. Labrucherie
General Counsel
Nektar Therapeutics
201 Industrial Road
San Carlos, CA 94070
(650) 620-5360]
13. Waiver of Unknown Claims. You further agree and acknowledge that the release provided for
in this Agreement shall apply to all unknown and unanticipated injuries and/or damages. You
acknowledge and understand that Section 1542 of the Civil Code of the State of California provides
as follows:
A general release does not extend to claims which the creditor does
not know or suspect to exist in his/her favor at the time of
executing the release, which if known by him/her must have
materially affected his/her settlement with the debtor.
Being aware of Section 1542 of the California Civil Code, you by signing this Agreement
expressly waive the provision of Section 1542 of the California Civil Code and any similar
provisions of law that may be applicable.
14. Entire Agreement; Modification. This Agreement, together with the Plan and your Employee
Agreement, constitute the complete and only agreement between you and the Company on these
subjects. You are agreeing to it without reliance on any promise or representation, written or
oral, other than those expressly contained in this Agreement, and it supersedes any other such
promises, warranties or representations. This Agreement may not be modified except in a writing
signed by both you and the Companys Vice President, Human Resources. This Agreement shall bind
the heirs, personal representatives, successors and assigns of both you and the Company, and inure
to the benefit of both you and the Company, their heirs, successors and assigns. Any determination
that a provision of this Agreement is invalid or unenforceable, in whole or in part, will not
affect any other provision of this Agreement, and the provision in question shall be modified by
the court so as to be rendered enforceable in accordance with the intent of the parties to the
extent possible.
5.
If this Agreement is acceptable to you, please sign below and return the original to Human
Resources on or before , 2008. You will not be entitled to any severance benefits
under the Plan if we do not receive the fully executed Agreement from you by the aforementioned
date and you do not revoke this Agreement within any revocation period provided under applicable
law.
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Nektar Therapeutics |
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By:
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Dated: |
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Dorian Rinella |
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SVP, Human Resources |
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[Employee Name] |
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Dated: |
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6.
Exhibit 10.20
Exhibit 10.20
NEKTAR THERAPEUTICS
2008 Equity Incentive Plan
Termination Date: March 20, 2018
1. Purposes.
(a) Adoption. The 2008 Equity Incentive Plan was approved by the Board of Directors on March
20, 2008.
(b) Eligible Stock Award Recipients. The persons eligible to receive Stock Awards are the
Employees, Directors and Consultants of the Company and its Affiliates.
(c) Available Stock Awards. The purpose of the Plan is to provide a means by which eligible
recipients of Stock Awards may be given an opportunity to benefit from increases in value of the
Common Stock through the granting of the following Stock Awards: (i) Incentive Stock Options, (ii)
Nonstatutory Stock Options, (iii) stock bonuses and (iv) rights to acquire restricted stock.
(d) General Purpose. The Company, by means of the Plan, seeks to retain the services of the
group of persons eligible to receive Stock Awards, to secure and retain the services of new members
of this group and to provide incentives for such persons to exert maximum efforts for the success
of the Company and its Affiliates.
2. Definitions.
(a) Affiliate means any parent corporation or subsidiary corporation of the Company, whether
now or hereafter existing, as those terms are defined in Sections 424(e) and (f), respectively, of
the Code.
(b) Board means the Board of Directors of the Company.
(c) Code means the Internal Revenue Code of 1986, as amended.
(d) Committee means a Committee appointed by the Board in accordance with subsection 3(c).
(e) Common Stock means the common stock of the Company.
(f) Company means Nektar Therapeutics, a Delaware corporation.
(g) Consultant means any person, including an advisor, (1) engaged by the Company or an
Affiliate to render consulting or advisory services and who is compensated for such services or (2)
who is a member of the Board of Directors of an Affiliate. However, the term Consultant shall not
include either Directors of the Company who are not compensated
by the Company for their services as Directors or Directors of the Company who are merely paid
a directors fee by the Company for their services as Directors.
(h) Continuous Service means that the Participants service with the Company or an
Affiliate, whether as an Employee, Director or Consultant, is not interrupted or terminated. The
Participants Continuous Service shall not be deemed to have terminated merely because of a change
in the capacity in which the Participant renders service to the Company or an Affiliate as an
Employee, Consultant or Director or a change in the entity for which the Participant renders such
service, provided that there is no interruption or termination of the Participants Continuous
Service. For example, a change in status from an Employee of the Company to a Consultant of an
Affiliate or a Director of the Company will not constitute an interruption of Continuous Service.
The Board or the chief executive officer of the Company, in that partys sole discretion, may
determine whether Continuous Service shall be considered interrupted in the case of any leave of
absence approved by that party, including sick leave, military leave or any other personal leave.
(i) Covered Employee means the chief executive officer and the four (4) other highest
compensated officers of the Company for whom total compensation is required to be reported to
stockholders under the Exchange Act, as determined for purposes of Section 162(m) of the Code.
(j) Director means a member of the Board of Directors of the Company.
(k) Disability means the permanent and total disability of a person within the meaning of
Section 22(e)(3) of the Code.
(l) Employee means any person employed by the Company or an Affiliate. Mere service as a
Director or payment of a directors fee by the Company or an Affiliate shall not be sufficient to
constitute employment by the Company or an Affiliate.
(m) Exchange Act means the Securities Exchange Act of 1934, as amended.
(n) Fair Market Value means, as of any date, the value of the Common Stock determined as
follows:
(i) If the Common Stock is listed on any established stock exchange or traded on the Nasdaq
Global Select Market, the Fair Market Value of a share of Common Stock shall be the closing sales
price for such stock (or the closing bid, if no sales were reported) as quoted on such exchange or
market (or the exchange or market with the greatest volume of trading in the Common Stock) on the
day of determination, as reported in The Wall Street Journal or such other source as the Board
deems reliable.
(ii) In the absence of such markets for the Common Stock, the Fair Market Value shall be
determined in good faith by the Board.
(o) Incentive Stock Option means an Option intended to qualify as an incentive stock option
within the meaning of Section 422 of the Code and the regulations promulgated thereunder.
2.
(p) Non-Employee Director means a Director of the Company who either (i) is not a current
Employee or Officer of the Company or its parent or a subsidiary, does not receive compensation
(directly or indirectly) from the Company or its parent or a subsidiary for services rendered as a
consultant or in any capacity other than as a Director (except for an amount as to which disclosure
would not be required under Item 404(a) of Regulation S-K promulgated pursuant to the Securities
Act (Regulation S-K)), does not possess an interest in any other transaction as to which
disclosure would be required under Item 404(a) of Regulation S-K and is not engaged in a business
relationship as to which disclosure would be required under Item 404(b) of Regulation S-K; or (ii)
is otherwise considered a non-employee director for purposes of Rule 16b-3.
(q) Nonstatutory Stock Option means an Option not intended to qualify as an Incentive Stock
Option.
(r) Officer means a person who is an officer of the Company within the meaning of Section 16
of the Exchange Act and the rules and regulations promulgated thereunder.
(s) Option means an Incentive Stock Option or a Nonstatutory Stock Option granted pursuant
to the Plan.
(t) Option Agreement means a written agreement between the Company and an Optionholder
evidencing the terms and conditions of an individual Option grant. Each Option Agreement shall be
subject to the terms and conditions of the Plan.
(u) Optionholder or Optionee means a person to whom an Option is granted pursuant to the
Plan or, if applicable, such other person who holds an outstanding Option.
(v) Outside Director means a Director of the Company who either (i) is not a current
employee of the Company or an affiliated corporation (within the meaning of Treasury Regulations
promulgated under Section 162(m) of the Code), is not a former employee of the Company or an
affiliated corporation receiving compensation for prior services (other than benefits under a tax
qualified pension plan), was not an officer of the Company or an affiliated corporation at any
time and is not currently receiving direct or indirect remuneration from the Company or an
affiliated corporation for services in any capacity other than as a Director or (ii) is otherwise
considered an outside director for purposes of Section 162(m) of the Code.
(w) Participant means a person to whom a Stock Award is granted pursuant to the Plan or, if
applicable, such other person who holds an outstanding Stock Award.
(x) Plan means this Nektar Therapeutics 2008 Equity Incentive Plan.
(y) Rule 16b-3 means Rule 16b-3 promulgated under the Exchange Act or any successor to Rule
16b-3, as in effect from time to time.
(z) Securities Act means the Securities Act of 1933, as amended.
3.
(aa) Stock Award means any right granted under the Plan, including an Option, a stock bonus
and a right to acquire restricted stock.
(bb) Stock Award Agreement means a written agreement between the Company and a holder of a
Stock Award evidencing the terms and conditions of an individual Stock Award grant. Each Stock
Award Agreement shall be subject to the terms and conditions of the Plan.
(cc) Ten Percent Stockholder means a person who owns (or is deemed to own pursuant to
Section 424(d) of the Code) stock possessing more than ten percent (10%) of the total combined
voting power of all classes of stock of the Company or of any of its Affiliates.
3. Administration.
(a) Administration by Board. The Board will administer the Plan unless and until the Board
delegates administration to a Committee, as provided in subsection 3(c).
(b) Powers of Board. The Board shall have the power, subject to, and within the limitations
of, the express provisions of the Plan:
(i) To determine from time to time which of the persons eligible under the Plan shall be
granted Stock Awards; when and how each Stock Award shall be granted; what type or combination of
types of Stock Award shall be granted; the provisions of each Stock Award granted (which need not
be identical), including the time or times when a person shall be permitted to receive stock
pursuant to a Stock Award; and the number of shares with respect to which a Stock Award shall be
granted to each such person.
(ii) To construe and interpret the Plan and Stock Awards granted under it, and to establish,
amend and revoke rules and regulations for its administration. The Board, in the exercise of this
power, may correct any defect, omission or inconsistency in the Plan or in any Stock Award
Agreement, in a manner and to the extent it shall deem necessary or expedient to make the Plan
fully effective.
(iii) To amend the Plan or a Stock Award as provided in Section 12.
(iv) Generally, to exercise such powers and to perform such acts as the Board deems necessary
or expedient to promote the best interests of the Company which are not in conflict with the
provisions of the Plan.
(c) Delegation to Committee.
(i) General. The Board may delegate administration of the Plan to a Committee or Committees
of one (1) or more members of the Board, and the term Committee
shall apply to any person or persons to whom such authority has been delegated. If
administration is delegated to a Committee, the Committee shall have, in connection with the
administration of the Plan, the powers theretofore possessed by the Board, including the power to
delegate to a subcommittee any of the administrative powers the Committee is authorized to exercise
(and references in this Plan to the Board shall thereafter be to the Committee or subcommittee),
subject, however, to such resolutions, not inconsistent with the provisions of the Plan, as may be
adopted from time to time by the Board. The Board may abolish the Committee at any time and revest
in the Board the administration of the Plan.
4.
(ii) Committee Composition when Common Stock is Publicly Traded. At such time as the Common
Stock is publicly traded, in the discretion of the Board, a Committee may consist solely of two or
more Outside Directors, in accordance with Section 162(m) of the Code, and/or solely of two or more
Non-Employee Directors, in accordance with Rule 16b-3. Within the scope of such authority, the
Board or the Committee may (i) delegate to a committee of one or more members of the Board who are
not Outside Directors, the authority to grant Stock Awards to eligible persons who are either (a)
not then Covered Employees and are not expected to be Covered Employees at the time of recognition
of income resulting from such Stock Award or (b) not persons with respect to whom the Company
wishes to comply with Section 162(m) of the Code and/or (ii) delegate to a committee of one or more
members of the Board who are not Non-Employee Directors the authority to grant Stock Awards to
eligible persons who are not then subject to Section 16 of the Exchange Act.
(d) Effect of Boards Decision. All determinations, interpretations and constructions made by
the Board in good faith shall not be subject to review by any person and shall be final, binding
and conclusive on all persons.
4. Shares Subject to the Plan.
(a) Share Reserve. Subject to the provisions of Section 11 relating to adjustments upon
changes in stock, the stock that may be issued pursuant to Stock Awards shall not exceed in the
aggregate Nine Million (9,000,000) shares of Common Stock. Subject to Section 4(b), the number of
shares available for issuance under the Plan shall be reduced by (i) one (1) share for each share
of stock issued pursuant to an Option granted under Section 6, and (ii) one and one-half (1.5)
shares for each share that is issued pursuant to a stock bonus award or restricted stock award
under Section 7.
(b) Reversion of Shares to the Share Reserve. If any Stock Award shall for any reason expire
or otherwise terminate, in whole or in part, without having been exercised in full or if any shares
of Common Stock issued to a Participant pursuant to a Stock Award are forfeited to or reacquired or
repurchased by the Company, including, but not limited to, any forfeiture, reacquisition or
repurchase caused by the failure to meet a contingency or condition required for the vesting of
such shares, the stock not acquired under such Stock Award shall revert to and again become
available for issuance under the Plan at the rate of (i) one (1) share for each share of stock that
had been issued pursuant to an Option granted under Section 6, and (ii) one and one-half (1.5)
shares for each share that had been issued pursuant to a stock bonus award or restricted stock
award under Section 7; provided, however, that if any unvested Common Stock
acquired pursuant to a Stock Award is forfeited to or reacquired or repurchased by the
Company, the unvested stock forfeited to or reacquired or repurchased by the Company shall revert
to and again become available for issuance under the Plan for all Stock Awards other than Incentive
Stock Options.
(c) Source of Shares. The stock subject to the Plan may be unissued shares or reacquired
shares, bought on the market or otherwise.
5.
5. Eligibility.
(a) Eligibility for Specific Stock Awards. Incentive Stock Options may be granted only to
Employees. Stock Awards other than Incentive Stock Options may be granted to Employees, Directors
and Consultants.
(b) Ten Percent Stockholders. No Ten Percent Stockholder shall be eligible for the grant of
an Incentive Stock Option unless the exercise price of such Option is at least one hundred ten
percent (110%) of the Fair Market Value of the Common Stock at the date of grant and the Option is
not exercisable after the expiration of five (5) years from the date of grant.
(c) Section 162(m) Limitation. Subject to the provisions of Section 11 relating to
adjustments upon changes in stock, no employee shall be eligible to be granted Options covering
more than Three Million (3,000,000) shares of the Common Stock during any calendar year.
(d) Consultants. A Consultant shall not be eligible for the grant of a Stock Award if, at the
time of grant, a Form S-8 Registration Statement under the Securities Act (Form S-8) is not
available to register either the offer or the sale of the Companys securities to such Consultant
because of the nature of the services that the Consultant is providing to the Company, or because
the Consultant is not a natural person, or as otherwise provided by the rules governing the use of
Form S-8, unless the Company determines both (i) that such grant (A) shall be registered in another
manner under the Securities Act (e.g., on a Form S-3 Registration Statement) or (B) does not
require registration under the Securities Act in order to comply with the requirements of the
Securities Act, if applicable, and (ii) that such grant complies with the securities laws of all
other relevant jurisdictions.
6. Option Provisions.
Each Option shall be in such form and shall contain such terms and conditions as the Board
shall deem appropriate. All Options shall be separately designated Incentive Stock Options or
Nonstatutory Stock Options at the time of grant, and a separate certificate or certificates will be
issued for shares purchased on exercise of each type of Option. The provisions of separate Options
need not be identical, but each Option shall include (through incorporation of provisions hereof by
reference in the Option or otherwise) the substance of each of the following provisions:
(a) Term. Subject to the provisions of subsection 5(b) regarding Ten Percent Stockholders, no
Incentive Stock Option shall be exercisable after the expiration of eight (8)
years from the date it was granted. No Nonstatutory Stock Option shall be exercisable after
the expiration of eight (8) years from the date it was granted.
6.
(b) Exercise Price of an Incentive Stock Option. Subject to the provisions of subsection 5(b)
regarding Ten Percent Stockholders, the exercise price of each Incentive Stock Option shall be not
less than one hundred percent (100%) of the Fair Market Value of the stock subject to the Option on
the date the Option is granted. Notwithstanding the foregoing, an Incentive Stock Option may be
granted with an exercise price lower than that set forth in the preceding sentence if such Option
is granted pursuant to an assumption or substitution for another option in a manner satisfying the
provisions of Section 424(a) of the Code.
(c) Exercise Price of a Nonstatutory Stock Option. The exercise price of each Nonstatutory
Stock Option shall be not less than one hundred percent (100%) of the Fair Market Value of the
stock subject to the Option on the date the Option is granted. Notwithstanding the foregoing, a
Nonstatutory Stock Option may be granted with an exercise price lower than that set forth in the
preceding sentence if such Option is granted pursuant to an assumption or substitution for another
option in a manner satisfying the provisions of Section 424(a) of the Code.
(d) Consideration.
(i) The purchase price of stock acquired pursuant to an Option shall be paid, to the extent
permitted by applicable statutes and regulations, either (A) in cash at the time the Option is
exercised or (B) at the discretion of the Board at the time of the grant of the Option (or
subsequently in the case of a Nonstatutory Stock Option) by delivery to the Company of other Common
Stock, according to a deferred payment or other similar arrangement (which may include, without
limiting the generality of the foregoing, the use of other Common Stock) with the Participant or in
any other form of legal consideration that may be acceptable to the Board; provided, however, that
at any time that the Company is incorporated in Delaware, payment of the Common Stocks par
value, as defined in the Delaware General Corporation Law, shall not be made by deferred payment.
(ii) Unless otherwise specifically provided in the Option, the purchase price of Common Stock
acquired pursuant to an Option that is paid by delivery to the Company of other Common Stock
acquired, directly or indirectly from the Company, shall be paid only by shares of the Common Stock
of the Company that have been held for more than six (6) months (or such longer or shorter period
of time required to avoid a charge to earnings for financial accounting purposes).
(iii) In the case of any deferred payment arrangement, interest shall be compounded at least
annually and shall be charged at the minimum rate of interest necessary to avoid the treatment as
interest, under any applicable provisions of the Code, of any amounts other than amounts stated to
be interest under the deferred payment arrangement.
(e) Transferability of an Incentive Stock Option. An Incentive Stock Option shall not be
transferable except by will or by the laws of descent and distribution and shall be
exercisable during the lifetime of the Optionholder only by the Optionholder. Notwithstanding
the foregoing provisions of this subsection 6(e), the Optionholder may, by delivering written
notice to the Company, in a form satisfactory to the Company, designate a third party who, in the
event of the death of the Optionholder, shall thereafter be entitled to exercise the Option.
7.
(f) Transferability of a Nonstatutory Stock Option. A Nonstatutory Stock Option shall be
transferable to the extent provided in the Option Agreement. If the Nonstatutory Stock Option does
not provide for transferability, then the Nonstatutory Stock Option shall not be transferable
except by will or by the laws of descent and distribution and shall be exercisable during the
lifetime of the Optionholder only by the Optionholder. Notwithstanding the foregoing provisions of
this subsection 6(f), the Optionholder may, by delivering written notice to the Company, in a form
satisfactory to the Company, designate a third party who, in the event of the death of the
Optionholder, shall thereafter be entitled to exercise the Option.
(g) Vesting Generally. The total number of shares of Common Stock subject to an Option may,
but need not, vest and therefore become exercisable in periodic installments which may, but need
not, be equal. The Option may be subject to such other terms and conditions on the time or times
when it may be exercised (which may be based on performance or other criteria) as the Board may
deem appropriate. The vesting provisions of individual Options may vary. The provisions of this
subsection 6(g) are subject to any Option provisions governing the minimum number of shares as to
which an Option may be exercised.
(h) Termination of Continuous Service. In the event an Optionholders Continuous Service
terminates (other than upon the Optionholders death or Disability), the Optionholder may exercise
his or her Option (to the extent that the Optionholder was entitled to exercise it as of the date
of termination) but only within such period of time ending on the earlier of (i) the date three (3)
months following the termination of the Optionholders Continuous Service (or such longer or
shorter period specified in the Option Agreement), or (ii) the expiration of the term of the Option
as set forth in the Option Agreement. If, after termination, the Optionholder does not exercise his
or her Option within the time specified in the Option Agreement, the Option shall terminate.
(i) Extension of Termination Date. An Optionholders Option Agreement may also provide that
if the exercise of the Option following the termination of the Optionholders Continuous Service
(other than upon the Optionholders death or Disability) would be prohibited at any time solely
because the issuance of shares would violate the registration requirements under the Securities
Act, then the Option shall terminate on the earlier of (i) the expiration of the term of the Option
set forth in subsection 6(a) or (ii) the expiration of a period of three (3) months (or such longer
or shorter period specified in the Option Agreement) after the termination of the Optionholders
Continuous Service during which the exercise of the Option would not be in violation of such
registration requirements.
(j) Disability of Optionholder. In the event an Optionholders Continuous Service terminates
as a result of the Optionholders Disability, the Optionholder may exercise his or her Option (to
the extent that the Optionholder was entitled to exercise it as of the date of termination), but
only within such period of time ending on the earlier of (i) the date twelve (12)
months following such termination (or such longer or shorter period specified in the Option
Agreement) or (ii) the expiration of the term of the Option as set forth in the Option Agreement.
If, after termination, the Optionholder does not exercise his or her Option within the time
specified herein, the Option shall terminate.
8.
(k) Death of Optionholder. In the event an Optionholders Continuous Service terminates as a
result of the Optionholders death, then, subject to any restrictions in the Option Agreement, the
Option shall become fully vested and exercisable as of the date of termination. In the event (i)
an Optionholders Continuous Service terminates as a result of the Optionholders death or (ii) the
Optionholder dies within the period (if any) specified in the Option Agreement after the
termination of the Optionholders Continuous Service for a reason other than death, then the Option
may be exercised (to the extent the Optionholder was entitled to exercise the Option as of the date
of death) by the Optionholders estate, by a person who acquired the right to exercise the Option
by bequest or inheritance or by a person designated to exercise the Option upon the Optionholders
death pursuant to subsection 6(e) or 6(f), but only within the period ending on the earlier of (1)
the date eighteen (18) months following the date of death (or such longer or shorter period
specified in the Option Agreement) or (2) the expiration of the term of such Option as set forth in
the Option Agreement. If, after death, the Option is not exercised within the time specified
herein, the Option shall terminate.
(l) Early Exercise. The Option may, but need not, include a provision whereby the
Optionholder may elect at any time before the Optionholders Continuous Service terminates to
exercise the Option as to any part or all of the shares subject to the Option prior to the full
vesting of the Option. Any unvested shares so purchased may be subject to an unvested share
repurchase option in favor of the Company or to any other restriction the Board determines to be
appropriate.
7. Provisions of Stock Awards Other than Options.
(a) Stock Bonus Awards. Each stock bonus agreement shall be in such form and shall contain
such terms and conditions as the Board shall deem appropriate. The terms and conditions of stock
bonus agreements may change from time to time, and the terms and conditions of separate stock bonus
agreements need not be identical, but each stock bonus agreement shall include (through
incorporation of provisions hereof by reference in the agreement or otherwise) the substance of
each of the following provisions:
(b) Consideration. A stock bonus shall be awarded in consideration for past services actually
rendered to the Company for its benefit.
(c) Vesting. Shares of Common Stock awarded under the stock bonus agreement may, but need
not, be subject to a share repurchase option in favor of the Company in accordance with a vesting
schedule to be determined by the Board.
(d) Termination of Participants Continuous Service. In the event a Participants Continuous
Service terminates, the Company may reacquire any or all of the shares of Common Stock held by the
Participant that have not vested as of the date of termination under the terms of
the stock bonus agreement; provided, however, that in the event a Participants Continuous
Service terminates as a result of the Participants death, then, subject to any restrictions in the
stock bonus agreement, the shares acquired pursuant to the stock bonus agreement shall become fully
vested as of the date of termination.
9.
(e) Transferability. Rights to acquire shares under the stock bonus agreement shall be
transferable by the Participant only upon such terms and conditions as are set forth in the stock
bonus agreement, as the Board shall determine in its discretion, so long as stock awarded under the
stock bonus agreement remains subject to the terms of the stock bonus agreement.
(f) Restricted Stock Awards. Each restricted stock purchase agreement shall be in such form
and shall contain such terms and conditions as the Board shall deem appropriate. The terms and
conditions of the restricted stock purchase agreements may change from time to time, and the terms
and conditions of separate restricted stock purchase agreements need not be identical, but each
restricted stock purchase agreement shall include (through incorporation of provisions hereof by
reference in the agreement or otherwise) the substance of each of the following provisions:
(g) Purchase Price. The purchase price under each restricted stock purchase agreement shall
be such amount as the Board shall determine and designate in such restricted stock purchase
agreement. The purchase price shall not be less than one hundred percent (100%) of the stocks Fair
Market Value on the date such award is made or at the time the purchase is consummated.
(h) Consideration. The purchase price of stock acquired pursuant to the restricted stock
purchase agreement shall be paid either: (i) in cash at the time of purchase; (ii) at the
discretion of the Board, according to a deferred payment or other similar arrangement with the
Participant; or (iii) in any other form of legal consideration that may be acceptable to the Board
in its discretion; provided, however, that at any time that the Company is incorporated in
Delaware, payment of the Common Stocks par value, as defined in the Delaware General Corporation
Law, shall not be made by deferred payment.
(i) Vesting. Shares of Common Stock acquired under the restricted stock purchase agreement
may, but need not, be subject to a share repurchase option in favor of the Company in accordance
with a vesting schedule to be determined by the Board.
(j) Termination of Participants Continuous Service. In the event a Participants Continuous
Service terminates, the Company may repurchase or otherwise reacquire any or all of the shares of
Common Stock held by the Participant that have not vested as of the date of termination under the
terms of the restricted stock purchase agreement; provided, however, that in the event a
Participants Continuous Service terminates as a result of the Participants death, then, subject
to any restrictions in the restricted stock purchase agreement, the shares acquired pursuant to the
restricted stock purchase agreement shall become fully vested as of the date of termination.
(k) Transferability. Rights to acquire shares under the restricted stock purchase agreement
shall be transferable by the Participant only upon such terms and conditions as are set forth in
the restricted stock purchase agreement, as the Board shall determine in its discretion, so long as
stock awarded under the restricted stock purchase agreement remains subject to the terms of the
restricted stock purchase agreement.
10.
8. Covenants of the Company.
(a) Availability of Shares. During the terms of the Stock Awards, the Company shall keep
available at all times the number of shares of Common Stock required to satisfy such Stock Awards.
(b) Securities Law Compliance. The Company shall seek to obtain from each regulatory
commission or agency having jurisdiction over the Plan such authority as may be required to grant
Stock Awards and to issue and sell shares of Common Stock upon exercise of the Stock Awards;
provided, however, that this undertaking shall not require the Company to register under the
Securities Act the Plan, any Stock Award or any stock issued or issuable pursuant to any such Stock
Award. If, after reasonable efforts, the Company is unable to obtain from any such regulatory
commission or agency the authority which counsel for the Company deems necessary for the lawful
issuance and sale of stock under the Plan, the Company shall be relieved from any liability for
failure to issue and sell stock upon exercise of such Stock Awards unless and until such authority
is obtained.
9. Use of Proceeds From Stock.
Proceeds from the sale of stock pursuant to Stock Awards shall constitute general funds of the
Company.
10. Miscellaneous.
(a) Acceleration of Exercisability and Vesting. The Board shall have the power to accelerate
the time at which a Stock Award may first be exercised or the time during which a Stock Award or
any part thereof will vest in accordance with the Plan, notwithstanding the provisions in the Stock
Award stating the time at which it may first be exercised or the time during which it will vest.
(b) Stockholder Rights. No Participant shall be deemed to be the holder of, or to have any of
the rights of a holder with respect to, any shares subject to such Stock Award unless and until
such Participant has satisfied all requirements for exercise of the Stock Award pursuant to its
terms.
(c) No Employment or other Service Rights. Nothing in the Plan or any instrument executed or
Stock Award granted pursuant thereto shall confer upon any Participant or other holder of Stock
Awards any right to continue to serve the Company or an Affiliate in the capacity in effect at the
time the Stock Award was granted or shall affect the right of the Company or an Affiliate to
terminate (i) the employment of an Employee with or without notice
and with or without cause, (ii) the service of a Consultant pursuant to the terms of such
Consultants agreement with the Company or an Affiliate or (iii) the service of a Director pursuant
to the Bylaws of the Company or an Affiliate, and any applicable provisions of the corporate law of
the state in which the Company or the Affiliate is incorporated, as the case may be.
11.
(d) Incentive Stock Option $100,000 Limitation. To the extent that the aggregate Fair Market
Value (determined at the time of grant) of stock with respect to which Incentive Stock Options are
exercisable for the first time by any Optionholder during any calendar year (under all plans of the
Company and its Affiliates) exceeds one hundred thousand dollars ($100,000), the Options or
portions thereof which exceed such limit (according to the order in which they were granted) shall
be treated as Nonstatutory Stock Options.
(e) Investment Assurances. The Company may require a Participant, as a condition of
exercising or acquiring stock under any Stock Award, (i) to give written assurances satisfactory to
the Company as to the Participants knowledge and experience in financial and business matters
and/or to employ a purchaser representative reasonably satisfactory to the Company who is
knowledgeable and experienced in financial and business matters and that he or she is capable of
evaluating, alone or together with the purchaser representative, the merits and risks of exercising
the Stock Award; and (ii) to give written assurances satisfactory to the Company stating that the
Participant is acquiring the stock subject to the Stock Award for the Participants own account and
not with any present intention of selling or otherwise distributing the stock. The foregoing
requirements, and any assurances given pursuant to such requirements, shall be inoperative if (iii)
the issuance of the shares upon the exercise or acquisition of stock under the Stock Award has been
registered under a then currently effective registration statement under the Securities Act or (iv)
as to any particular requirement, a determination is made by counsel for the Company that such
requirement need not be met in the circumstances under the then applicable securities laws. The
Company may, upon advice of counsel to the Company, place legends on stock certificates issued
under the Plan as such counsel deems necessary or appropriate in order to comply with applicable
securities laws, including, but not limited to, legends restricting the transfer of the stock.
(f) Withholding Obligations. To the extent provided by the terms of a Stock Award Agreement,
the Participant may satisfy any federal, state or local tax withholding obligation relating to the
exercise or acquisition of stock under a Stock Award by any of the following means (in addition to
the Companys right to withhold from any compensation paid to the Participant by the Company) or by
a combination of such means: (i) tendering a cash payment; (ii) authorizing the Company to withhold
shares from the shares of the Common Stock otherwise issuable to the Participant as a result of the
exercise or acquisition of stock under the Stock Award, provided, however, that no shares of Common
Stock are withheld with a value exceeding the minimum amount of tax required to be withheld by law;
or (iii) delivering to the Company owned and unencumbered shares of the Common Stock. The
Participant is solely responsible for satisfaction of all federal, state or local tax withholding
obligations relating to the exercise or acquisition of stock under a Stock Award and no shares of
Common Stock will be issued until the Company has received a definitive agreement or other
documentation satisfactory to the
Company, in its sole discretion, that such withholding obligations have been or will be
satisfied by the Participant.
12.
11. Adjustments Upon Changes in Stock.
(a) Capitalization Adjustments. If any change is made in the stock subject to the Plan, or
subject to any Stock Award, without the receipt of consideration by the Company (through merger,
consolidation, reorganization, recapitalization, reincorporation, stock dividend, dividend in
property other than cash, stock split, liquidating dividend, combination of shares, exchange of
shares, change in corporate structure or other transaction not involving the receipt of
consideration by the Company), the Plan will be appropriately adjusted in the class(es) and maximum
number of securities subject to the Plan pursuant to subsection 4(a) and the maximum number of
securities subject to award to any person pursuant to subsection 5(c), and the outstanding Stock
Awards will be appropriately adjusted in the class(es) and number of securities and price per share
of stock subject to such outstanding Stock Awards. Such adjustments shall be made by the Board, the
determination of which shall be final, binding and conclusive. (The conversion of any convertible
securities of the Company shall not be treated as a transaction without receipt of consideration
by the Company.)
(b) Dissolution or Liquidation. In the event of a dissolution or liquidation of the Company,
then such Stock Awards shall be terminated if not exercised (if applicable) prior to such event.
(c) Corporate Transaction. In the event of (1) a sale, lease or other disposition of all or
substantially all of the assets of the Company, (2) a merger or consolidation in which the Company
is not the surviving corporation or (3) a reverse merger in which the Company is the surviving
corporation but the shares of Common Stock outstanding immediately preceding the merger are
converted by virtue of the merger into other property, whether in the form of securities, cash or
otherwise (a Corporate Transaction), then any surviving corporation or acquiring corporation
shall assume any Stock Awards outstanding under the Plan or shall substitute similar stock awards
(including an award to acquire the same consideration paid to the stockholders in the Corporate
Transaction) for those outstanding under the Plan. In the event any surviving corporation or
acquiring corporation refuses to assume such Stock Awards or to substitute similar stock awards for
those outstanding under the Plan, then with respect to Stock Awards held by Participants whose
Continuous Service has not terminated, the vesting of such Stock Awards (and, if applicable, the
time during which such Stock Awards may be exercised) shall be accelerated in full, and the Stock
Awards shall terminate if not exercised (if applicable) at or prior to such Corporate Transaction.
With respect to any other Stock Awards outstanding under the Plan, such Stock Awards shall
terminate if not exercised (if applicable) prior to such Corporate Transaction.
(d) Securities Acquisition. In the event of an acquisition by any person, entity or group
within the meaning of Section 13(d) or 14(d) of the Exchange Act, or any comparable successor
provisions (excluding any employee benefit plan, or related trust, sponsored or maintained by the
Company or an Affiliate) of the beneficial ownership (within the meaning of Rule 13d-3 promulgated
under the Exchange Act, or comparable successor rule) of securities of
the Company representing at least fifty percent (50%) of the combined voting power entitled to
vote in the election of Directors and provided that such acquisition is not a result of, and does
not constitute, a Corporate Transaction described in subsection 11(c) hereof, then with respect to
Stock Awards held by Participants whose Continuous Service has not terminated, the vesting of such
Stock Awards (and, if applicable, the time during which such Stock Awards may be exercised) shall
be accelerated in full.
13.
12. Amendment of the Plan and Stock Awards.
(a) Amendment of Plan. The Board at any time, and from time to time, may amend the Plan.
However, except as provided in Section 11 relating to adjustments upon changes in stock, no
amendment shall be effective unless approved by the stockholders of the Company to the extent
stockholder approval is necessary to satisfy the requirements of Section 422 of the Code, Rule
16b-3 or any Nasdaq or securities exchange listing requirements.
(b) Stockholder Approval. The Board may, in its sole discretion, submit any other amendment
to the Plan for stockholder approval, including, but not limited to, amendments to the Plan
intended to satisfy the requirements of Section 162(m) of the Code and the regulations thereunder
regarding the exclusion of performance-based compensation from the limit on corporate deductibility
of compensation paid to certain executive officers.
(c) Contemplated Amendments. It is expressly contemplated that the Board may amend the Plan
in any respect the Board deems necessary or advisable to provide eligible Employees with the
maximum benefits provided or to be provided under the provisions of the Code and the regulations
promulgated thereunder relating to Incentive Stock Options and/or to bring the Plan and/or
Incentive Stock Options granted under it into compliance therewith.
(d) No Impairment of Rights. Rights under any Stock Award granted before amendment of the
Plan shall not be impaired by any amendment of the Plan unless (i) the Company requests the consent
of the Participant and (ii) the Participant consents in writing.
(e) Amendment of Stock Awards. The Board at any time, and from time to time, may amend the
terms of any one or more Stock Awards; provided, however, that the rights under any Stock Award
shall not be impaired by any such amendment unless (i) the Company requests the consent of the
Participant and (ii) the Participant consents in writing.
(f) Repricing of Stock Awards. Without prior stockholder approval, the Board will not effect
a repricing (as hereinafter defined) of any Stock Awards under the Plan. For purposes of the
immediately preceding sentence, a repricing shall be deemed to mean any of the following actions:
(a) the lowering of the purchase price of a Stock Award after it is granted; (b) the canceling of a
Stock Award in exchange for another Stock Award at a time when the purchase price of the cancelled
Stock Award exceeds the Fair Market Value of the underlying stock (unless the cancellation and
exchange occurs in connection with a merger, acquisition, spin-off, dissolution, winding up or
other similar corporate transaction with respect to the Company or any subsidiary of the Company to
which the holder of such Stock Award is providing or had provided service); or (c) the purchase of
a Stock Award for cash or other
consideration at a time when the purchase price of the purchased Stock Award exceeds the Fair
Market Value of the underlying stock (unless the purchase occurs in connection with a merger,
acquisition, spin-off, dissolution, winding up or other similar corporate transaction with respect
to the Company or any subsidiary of the Company to which the holder of such Stock Award is
providing or had provided service).
14.
13. Termination or Suspension of the Plan.
(a) Plan Term. The Board may suspend or terminate the Plan at any time. Unless sooner
terminated, the Plan shall terminate on March 20, 2018. No Stock Awards may be granted under the
Plan while the Plan is suspended or after it is terminated.
(b) No Impairment of Rights. Rights and obligations under any Stock Award granted while the
Plan is in effect shall not be impaired by suspension or termination of the Plan, except with the
written consent of the Participant.
14. Effective Date of Plan.
The Plan shall become effective upon adoption by the Board, but no Stock Award shall be
exercised (or, in the case of a stock bonus, shall be granted) unless and until the Plan has been
approved by the stockholders of the Company, which approval shall be within twelve (12) months
before or after the date the Plan is adopted by the Board.
15. Choice of Law.
The law of the State of Delaware shall govern all questions concerning the construction,
validity and interpretation of this Plan, without regard to such states conflict of laws rules.
15.
Filed by Bowne Pure Compliance
Exhibit 10.21
Nektar Therapeutics
2008 Equity Incentive Plan
Stock Option Grant Notice
(US Optionholders)
Nektar Therapeutics (the Company), pursuant to its 2008 Equity Incentive Plan (the Plan),
hereby grants to you, the Optionholder, an option to purchase the number of shares of the Companys
Common Stock set forth below. This Option is subject to all of the terms and conditions as set
forth herein and in the Stock Option Agreement, the Plan and the Notice of Exercise, all of which
are attached hereto and incorporated herein in their entirety. Capitalized terms not otherwise
defined herein shall have the meanings set forth in the Plan or the Stock Option Agreement.
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Optionholder: |
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Date of Grant:
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Vesting Commencement Date:
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Number of Shares Subject to Option:
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Exercise Price Per Share:
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Expiration Date:
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Exercise Schedule: |
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Same as Vesting Schedule |
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Vesting Schedule: |
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of the shares vest one year after the Vesting Commencement Date. |
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of the shares vest monthly thereafter over the next |
years. |
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Additional Terms/Acknowledgements: You acknowledge receipt of, and understand and agree to, this
Grant Notice, the Stock Option Agreement and the Plan. You further acknowledge that as of the Date
of Grant, this Grant Notice, the Stock Option Agreement and the Plan set forth the entire
understanding between you and the Company regarding the acquisition of stock in the Company and
supersede all prior oral and written agreements on that subject with the exception of (i) Options
previously granted and delivered to you under the Plan, and (ii) the following agreements only:
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Nektar Therapeutics: |
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Signature
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Attachments: Stock Option Agreement, 2008 Equity Incentive Plan, and Notice of Exercise
1
Nektar Therapeutics
2008 Equity Incentive Plan
Stock Option Agreement
(US Optionholders)
Pursuant to the Stock Option Grant Notice (Option Notice) and this Stock Option Agreement,
Nektar Therapeutics (the Company) has granted you an option under its 2008 Equity Incentive Plan
(the Plan) to purchase the number of shares of the Companys Common Stock indicated in the Option
Notice at the exercise price indicated in the Option Notice. Defined terms not explicitly defined
in this Stock Option Agreement but defined in the Plan shall have the same definitions as in the
Plan.
The details of your option are as follows:
1. Vesting. Subject to the limitations contained herein, your option will vest as
provided in the Option Notice, provided that vesting will cease upon the termination of your
Continuous Service. Notwithstanding the foregoing, in the event your Continuous Service is
terminated as a result of your death, your option shall become fully vested and exercisable as of
the date of such termination.
2. Number of Shares and Exercise Price. The number of shares subject to your option
and your exercise price per share referenced in the Option Notice may be adjusted from time to time
for capitalization adjustments, as provided in the Plan.
3. Exercise
Restriction for Non-Exempt Employees. If you are an Employee eligible
for overtime compensation under the Fair Labor Standards Act of 1938, as amended (i.e., a
Non-Exempt Employee), you may not exercise your option until at least six (6) months following
the Date of Grant specified in your Option Notice, notwithstanding any other provision of your
option.
4. Method of Payment. Payment of the exercise price is due in full upon exercise of
all or any part of your option. You may elect to make payment of the exercise price in one or more
of the following forms:
(a) In cash or by check;
(b) In the Companys sole discretion at the time your option is exercised and provided that at
the time of exercise the Common Stock is publicly traded and quoted regularly in The Wall Street
Journal, pursuant to a program developed under Regulation T as promulgated by the Federal Reserve
Board which, prior to the issuance of Common Stock, results in either the receipt of cash (or
check) by the Company or the receipt of irrevocable instructions to pay the aggregate exercise
price to the Company from the sales proceeds; or
2
(c) In the Companys sole discretion at the time your option is granted and provided that at
the time of exercise the Common Stock is publicly traded and quoted regularly in The Wall Street
Journal, by delivery of already-owned shares of Common Stock either that you have held for the
period required to avoid a charge to the Companys reported earnings (generally six months) or that
you did not acquire, directly or indirectly from the Company, that are owned free and clear of any
liens, claims, encumbrances or security interests, and that are valued at Fair Market Value on the
date of exercise. Delivery for these purposes, in the sole discretion of the Company at the time
your option is exercised, shall include delivery to the Company of your attestation of ownership of
such shares of Common Stock in a form approved by the Company. Notwithstanding the foregoing, your
option may not be exercised by tender to the Company of Common Stock to the extent such tender
would constitute a violation of the provisions of any law, regulation or agreement restricting the
redemption of the Companys stock.
5. Securities Law Compliance. Notwithstanding anything to the contrary contained
herein, your option may not be exercised unless the shares issuable upon exercise of your option
are then registered under the Securities Act or, if such shares are not then so registered, the
Company has determined that such exercise and issuance would be exempt from the registration
requirements of the Securities Act. The exercise of your option must also comply with other
applicable laws and regulations governing the option, and the option may not be exercised if the
Company determines that the exercise would not be in material compliance with such laws and
regulations.
6. Term. The term of your option commences on the Date of Grant and expires upon the
earliest of the following:
(a) three (3) months after the termination of your Continuous Service for any reason other
than death or Disability, provided that (i) if during any part of such three (3)-month period the
option is not exercisable solely because of the condition set forth in Section 5, the option shall
not expire until the earlier of the Expiration Date indicated on the Option Notice or until it
shall have been exercisable for an aggregate period of three (3) months after the termination of
your Continuous Service, and (ii) if (x) you are a Non-Exempt Employee, (y) you terminate your
Continuous Service within six (6) months after the Date of Grant specified in your Option Notice,
and (z) you have vested in a portion of your option at the time of your termination of Continuous
Service, your option shall not expire until the earlier of (A) the later of the date that is seven
(7) months after the Date of Grant specified in your Option Notice or the date that is three (3)
months after the termination of your Continuous Service or (B) the Expiration Date;
(b) twelve (12) months after the termination of your Continuous Service due to Disability;
(c) eighteen (18) months after your death if you die either during your Continuous Service or
within three (3) months after your Continuous Service terminates for a reason other than death;
3
(d) the Expiration Date indicated in the Option Notice; or
(e) the eighth (8th) anniversary of the Date of Grant.
Note, if you are a US taxpayer and your option is an incentive stock option, to obtain the
federal income tax advantages associated with an incentive stock option, the Code requires that
at all times beginning on the Date of Grant of your option and ending on the day three (3) months
before the date of your options exercise, you must be an employee of the Company or an Affiliate,
except in the event of your death or Disability. The Company has provided for extended
exercisability of your option under certain circumstances for your benefit but cannot guarantee
that your option will necessarily be treated as an incentive stock option if you continue to
provide services to the Company or an Affiliate as a Consultant or Director after your employment
terminates or if you otherwise exercise your option more than three (3) months after the date your
employment terminates.
7.
Exercise.
(a) You may exercise the vested portion of your option during its term by delivering a Notice
of Exercise (in a form designated by the Company) together with the exercise price to the Secretary
of the Company, or to such other person as the Company may designate, during regular business
hours, together with such additional documents as the Company may then require.
(b) By exercising your option you agree that, as a condition to any exercise of your option,
the Company may require you to enter an arrangement providing for the payment by you to the Company
of any tax withholding as described in Section 10 below by reason of (1) the exercise of your
option, (2) the lapse of any substantial risk of forfeiture to which the shares of Common Stock are
subject at the time of exercise, or (3) the disposition of shares of Common Stock acquired upon
such exercise.
(c) If your option is an incentive stock option, by exercising your option you agree that you
will notify the Company in writing within fifteen (15) days after the date of any disposition of
any of the shares of the Common Stock issued upon exercise of your option that occurs within two
(2) years after the date of your option grant or within one (1) year after such shares of Common
Stock are transferred upon exercise of your option.
8. Transferability. Your option is not transferable, except by will or by the laws
of descent and distribution, and is exercisable during your life only by you. Notwithstanding the
foregoing, by delivering written notice to the Company, in a form satisfactory to the Company, you
may designate a third party who, in the event of your death, shall thereafter be entitled to
exercise your option.
9. Option not a Service Contract. Your option is not an employment or service
contract, and nothing in your option shall be deemed to create in any way whatsoever any obligation
on your part to continue in the employ of the Company or an Affiliate, or of the Company or an
Affiliate to continue your employment. In addition, nothing in your option shall
obligate the Company or an Affiliate, their respective shareholders, Boards of Directors,
Officers or Employees to continue any relationship that you might have as a Director or Consultant
for the Company or an Affiliate.
4
10.
Tax Obligations.
(a) You are responsible for satisfaction of all federal, state, local and foreign tax
withholding obligations of the Company and its Affiliates, if any, which arise in connection with
the option, including, without limitation, obligations arising upon (i) the exercise, in whole or
in part, of the option, (ii) the transfer, in whole or in part, of any shares acquired upon
exercise of the option, (iii) the operation of any law or regulation providing for the imputation
of interest, or (iv) the lapsing of any restriction with respect to any shares acquired upon
exercise of the option. No shares of Common Stock will be issued until the Company has received a
definitive agreement or other documentation satisfactory to the Company, in its sole discretion,
that all such obligations have been or will be satisfied by you. Regardless of whether the Company
properly withholds the full amount of such obligations, you hereby acknowledge and agree that that
all such obligations shall transfer in their entirety from the Company to you and that such
liability shall be ultimately your responsibility and liability.
(b) You hereby authorize withholding from payroll and any other amounts payable to you and
otherwise agree to make adequate provision for any sums required to satisfy the federal, state,
local and foreign tax obligations, if any, which are owed by you in connection with the option.
(c) The Company may, in its discretion, permit or require you to satisfy all or any portion
of the tax obligations described in this Section 10 by deducting from the shares of Common Stock
otherwise deliverable to you in settlement of the option a number of shares of Common Stock having
a fair market value, as determined by the Company as of the date on which the tax obligations
arise, not in excess of the amount of such tax obligations determined by the applicable withholding
rates. In the event that the Company determines that the tax obligations will not be satisfied by
the methods described above, you authorize the designated plan administrator or any successor plan
administrator, to sell a number of shares of Common Stock that are exercised under the option,
which the Company determines is sufficient to generate an amount that meets the tax obligations
plus additional shares of Common Stock, as necessary, to account for rounding and market
fluctuation, and to pay such tax withholding amounts to the Company. The shares may be sold as
part of a block trade with other Participants of the Plan in which all Participants receive an
average price. Any adverse consequences to you resulting from the procedure permitted under this
Section 10, including, without limitation, tax consequences, shall be your sole responsibility.
(d) You hereby acknowledge that you understand that you may suffer adverse tax consequences
as a result of the exercise of the option or disposition of the shares. You hereby represent that
you have consulted with any tax consultants the you deem advisable in connection with the exercise
of the option or disposition of the shares and that you are not relying on the Company for any tax
advice.
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11.
Employment Conditions. In accepting the option, you acknowledge that:
(a) Any notice period mandated under the applicable laws shall not be treated as service for
the purpose of determining the vesting of the option; and your right to receive shares of Common
Stock in settlement of the option after termination as an Employee, if any, will be measured by the
date of your termination as an Employee and will not be extended by any notice period mandated
under the applicable law. Subject to the foregoing and the provisions of the Plan, the Company, in
its sole discretion, shall determine whether your status as an Employee has terminated and the
effective date of such termination.
(b) The vesting of the option shall cease upon, and no portion of the option shall become
vested following, your termination as an Employee for any reason except as may be explicitly
provided by the Plan or this Stock Option Agreement. Unless otherwise provided in the Plan or this
Stock Option Agreement, the unvested portion of the option at the time of your termination as an
Employee will be forfeited.
(c) The Plan is established voluntarily by the Company. It is discretionary in nature and it
may be modified, amended, suspended or terminated by the Company at any time, unless otherwise
provided in the Plan and this Stock Option Agreement.
(d) The grant of the option is voluntary and occasional and does not create any contractual
or other right to receive future grants of options, or benefits in lieu of options, even if options
have been granted repeatedly in the past.
(e) All decisions with respect to future option grants, if any, will be at the sole
discretion of the Company.
(f) You are voluntarily participating in the Plan.
(g) The option is an extraordinary item that does not constitute compensation of any kind for
service rendered to the Company (or any Affiliate), and which is outside the scope of your
employment contract, if any. In addition, the option is not part of normal or expected
compensation or salary for any purpose, including, but not limited to, calculating any severance,
resignation, termination, redundancy, end-of-service payments, bonuses, long-service awards,
pension or retirement benefits or similar payments.
(h) The future value of the underlying shares of Common Stock is unknown and cannot be
predicted with certainty. If you obtain shares upon settlement of the option, the value of those
shares may increase or decrease.
(i) No claim or entitlement to compensation or damages arises from termination of the option
or diminution in value of the option or shares of Common Stock acquired upon settlement of the
option resulting from your termination as an Employee (for any reason whether or not in breach of
the local law) and you irrevocably release the Company and each Affiliate from any such claim that
may arise. If, notwithstanding the foregoing, any such claim is found
by a court of competent jurisdiction to have arisen then, by signing this Stock Option
Agreement, you shall be deemed irrevocably to have waived your entitlement to pursue such a claim.
6
12.
General Provisions.
(a) Successors and Assigns. Except as provided herein to the contrary, this Stock
Option Agreement shall be binding upon and inure to the benefit of the parties to this Stock Option
Agreement, their respective successors and permitted assigns.
(b) No Assignment. Except as otherwise provided in this Stock Option Agreement, you
shall not assign any of your under this Stock Option Agreement without the prior written consent of
the Company, which consent may be withheld in its sole discretion. The Company shall be permitted
to assign its rights or obligations under this Stock Option Agreement, but no such assignment shall
release the Company of any obligations pursuant to this Stock Option Agreement.
(c) Severability. The validity, legality or enforceability of the remainder of this
Stock Option Agreement shall not be affected even if one or more of the provisions of this Stock
Option Agreement shall be held to be invalid, illegal or unenforceable in any respect.
(d) Administration. Any determination by the Administrator in connection with any
question or issue arising under the Plan or this Stock Option Agreement shall be final, conclusive,
and binding on you, the Company, and all other persons.
(e) Headings. The section headings in this Stock Option Agreement are inserted only
as a matter of convenience, and in no way define, limit or interpret the scope of this Stock Option
Agreement or of any particular section.
(f) Delivery of Documents and Notices. Any document relating to participation in the
Plan, or any notice required or permitted hereunder shall be given in writing and shall be deemed
effectively given (except to the extent that this Stock Option Agreement provides for effectiveness
only upon actual receipt of such notice) upon personal delivery through electronic delivery at the
e-mail address, if any, provided for you by the Company, or, upon deposit in the local postal
service, by registered or certified mail, or with a nationally recognized overnight courier service
with postage and fees prepaid, addressed to the other party at the address of such party set forth
in this Stock Option Agreement or at such other address as such party may designate in writing from
time to time to the other party.
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(i) Description of Electronic Delivery. The Plan documents, which may include but do
not necessarily include: the Plan, the Option Notice, this Stock Option Agreement, and any reports
of the Company provided generally to the Companys shareholders, may be delivered to you
electronically. In addition, if permitted by the Company, you may deliver electronically this
Stock Option Agreement and Exercise Notice called for by Section 7(a) to the Company or to such
third party involved in administering the Plan as the Company may designate from time to time.
Such means of electronic delivery may include but do not necessarily include the delivery of a link
to a Company intranet or the internet site of a third party involved in administering the Plan, the
delivery of the document via e-mail or such other means of electronic delivery specified by the
Company.
(ii) Consent to Electronic Delivery. You acknowledge that you have read
Section 12(f)(i) of this Stock Option Agreement and consent to the electronic delivery of the Plan
documents and, if permitted by the Company, the delivery of this Stock Option Agreement and
exercise notice, as described in Section 12(f)(i) You acknowledge that you may receive from the
Company a paper copy of any documents delivered electronically at no cost to you by contacting the
Company by telephone or in writing. You further acknowledge that you will be provided with a paper
copy of any documents if the attempted electronic delivery of such documents fails. Similarly, you
understand that you must provide the Company or any designated third party administrator with a
paper copy of any documents if the attempted electronic delivery of such documents fails. You may
revoke your consent to the electronic delivery of documents described in Section 12(f)(i) or may
change the electronic mail address to which such documents are to be delivered (if you have
provided an electronic mail address) at any time by notifying the Company of such revoked consent
or revised e-mail address by telephone, postal service or electronic mail. Finally, you understand
that you are not required to consent to electronic delivery of documents described in
Section 12(f)(i).
14. Governing Plan Document. Your option is subject to all the provisions
of the Plan, the provisions of which are hereby made a part of your option, and is further subject
to all interpretations, amendments, rules and regulations which may from time to time be
promulgated and adopted pursuant to the Plan. In the event of any conflict between the provisions
of your option and those of the Plan, the provisions of the Plan shall control. This Stock Option
Agreement is governed by the laws of the State of Delaware.
8
Filed by Bowne Pure Compliance
Exhibit 10.22
Nektar Therapeutics
2008 Equity Incentive Plan
Restricted Stock Unit Grant Notice
(US Participants)
Nektar Therapeutics (the Company), pursuant to its 2008 Equity Incentive Plan (the Plan),
hereby awards to you, the Participant, the number of Restricted Stock Units set forth below
(Award). This Award is subject to all of the terms and conditions as set forth herein and in the
Restricted Stock Unit Agreement and the Plan, both of which are attached hereto and incorporated
herein in their entirety.
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Vesting Schedule:
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Subject to the limitations contained herein, the
Restricted Stock Units subject to this Award shall vest
as follows: (i)
_____% of the Restricted Stock Units
shall vest on [date], (ii)
_____% of the Restricted Stock
Units shall vest on [date], (iii)
_____% of the Restricted
Stock Units shall vest on [date], and (iv)
_____% of the
Restricted Stock Units shall vest on [date]. |
Additional Terms/Acknowledgements: You acknowledge receipt of, and understand and agree to, this
Restricted Stock Unit Grant Notice, the Restricted Stock Unit Agreement and the Plan. You further
acknowledge that as of the Date of Grant, this Restricted Stock Unit Grant Notice, the Restricted
Stock Unit Agreement and the Plan set forth the entire understanding between you and the Company
regarding the acquisition of Restricted Stock Units of the Company and supersede all prior oral and
written agreements on that subject with the exception of (i) Awards previously granted and
delivered to you under the Plan, and (ii) the following agreements only:
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Nektar Therapeutics: |
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Signature
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Attachments: Restricted Stock Unit Agreement, 2008 Equity Incentive Plan
Nektar Therapeutics
2008 Equity Incentive Plan
Restricted Stock Unit Agreement
(US Participants)
Pursuant to your Restricted Stock Unit Grant Notice (Grant Notice) and this Restricted Stock
Unit Agreement (Agreement) (collectively, the Award), Nektar Therapeutics (the Company) has
awarded you, pursuant to its 2008 Equity Incentive Plan (the Plan), the number of Restricted
Stock Units as indicated in the Grant Notice. Defined terms not explicitly defined in this
Agreement but defined in the Plan shall have the same definitions as in the Plan.
The details of your Award are as follows.
1. Vesting. Subject to the limitations contained herein, your Award shall vest as
provided in the Grant Notice, provided that vesting shall cease upon the termination of your
Continuous Service. Any Restricted Stock Units that have not vested shall be forfeited upon the
termination of your Continuous Service.
2. Dividends. You shall not receive any payment or other adjustment in the number of
your Restricted Stock Units for dividends or other distributions that may be made in respect of the
shares of Common Stock to which your Restricted Stock Units relate.
3. Distribution of Shares of Common Stock. The Company will deliver to you a number
of shares of Common Stock equal to the number of vested shares of Common Stock subject to your
Award on the vesting date or dates provided in your Grant Notice; provided, however, that the
shares of Common Stock subject to your Award that vest on or prior to the execution of your Grant
Notice shall be delivered as soon as practicable following the date of execution of your Grant
Notice; and provided further, however, that in the event that the Company determines that you are
subject to its policy regarding insider trading of the Companys stock and any shares of Common
Stock subject to your Award are scheduled to be delivered on a day (the Original Distribution
Date) that does not occur during a window period applicable to you, as determined by the Company
in accordance with such policy, then such shares shall not be delivered on such Original
Distribution Date and shall instead be delivered as soon as practicable within the next window
period applicable to you pursuant to such policy.
4. Number of Shares. The number of Restricted Stock Units subject to your Award may
be adjusted from time to time for capitalization adjustments, as provided in Section 11(a) of the
Plan.
5. Securities Law Compliance. You may not be issued any shares of Common Stock under
your Award unless the shares of Common Stock are either (i) then registered under the Securities
Act or (ii) the Company has determined that such issuance would be exempt from the registration
requirements of the Securities Act. Your Award must also comply with other applicable laws and
regulations governing the Award, and you shall not receive such shares if the
Company determines that such receipt would not be in material compliance with such laws and
regulations.
6. Execution
of Documents. You hereby acknowledge and agree that the manner selected
by the Company by which you indicate your consent to your Grant Notice is also deemed to be your
execution of your Grant Notice and of this Agreement. You further agree that such manner of
indicating consent may be relied upon as your signature for establishing your execution of any
documents to be executed in the future in connection with your Award. This Agreement shall be
deemed to be signed by the Company and you upon the respective signing by the Company and you of
the Grant Notice to which it is attached.
7. Restrictive
Legends. The shares of Common Stock issued under your Award shall be
endorsed with appropriate legends, if any, determined by the Company.
8. Transferability. Your Award is not transferable, except by will or by the laws of
descent and distribution. Notwithstanding the foregoing, by delivering written notice to the
Company, in a form satisfactory to the Company, you may designate a third party who, in the event
of your death, shall thereafter be entitled to receive any distribution of shares of Common Stock
pursuant to Section 3 of this Agreement.
9. Award not a Service Contract. Your Award is not an employment or service
contract, and nothing in your Award shall be deemed to create in any way whatsoever any obligation
on your part to continue in the service of the Company or an Affiliate, or on the part of the
Company or an Affiliate to continue such service. In addition, nothing in your Award shall
obligate the Company or an Affiliate, their respective stockholders, boards of directors, Officers
or Employees to continue any relationship that you might have as an Employee, Director or
Consultant for the Company or an Affiliate.
10. Unsecured Obligation. Your Award is unfunded, and as a holder of vested
Restricted Stock Units subject to your Award, you shall be considered an unsecured creditor of the
Company with respect to the Companys obligation, if any, to issue shares of Common Stock pursuant
to Section 3 of this Agreement.
11.
Tax Obligations.
(a) At the time the Grant Notice is executed, or at any time thereafter as requested by the
Company, you hereby authorize withholding from payroll and any other amounts payable to you, and
otherwise agree to make adequate provision for, any sums required to satisfy the federal, state,
local and foreign tax withholding obligations of the Company, if any, which arise in connection
with the Award or the issuance of shares of Common Stock in settlement thereof. The Company shall
have no obligation to deliver shares of Common Stock until the tax withholding obligations of the
Company have been satisfied by you.
(b) The Company may, in its sole discretion, permit or require you to satisfy all or any
portion of the tax obligations by deducting from the shares of Common Stock otherwise deliverable
to you in settlement of the Award a number of shares of Common Stock having a fair market value, as
determined by the Company as of the date on which the tax obligations arise, not in excess of the
amount of such tax obligations determined by the applicable withholding
rates. In the event that the Company determines that the tax obligations will not be
satisfied by the method described above, you authorize the designated plan administrator, or any
successor plan administrator, to sell a number of shares of Common Stock that are issued under the
Award, which the Company determines is sufficient to generate an amount that meets the tax
obligations plus additional shares, as necessary, to account for rounding and market fluctuations,
and to pay such tax withholding amounts to the Company. The shares of Common Stock may be sold as
part of a block trade with other Participants of the Plan in which all Participants receive an
average price. Any adverse consequences to you resulting from the procedure permitted under this
Section 11, including, without limitation, tax consequences, shall be your sole responsibility.
(c) You hereby acknowledge that you understand that you may suffer adverse tax consequences
as a result of your participation in the Plan. You hereby represent that you have consulted with
any tax consultants you deem advisable in connection with the Award or disposition of the shares of
Common Stock received under the Award and that you are not relying on the Company for any tax
advice.
(d) Payments contemplated with respect to the Award are intended to comply with the
short-term deferral exemption under Section 409A of the Code. Notwithstanding any contrary
provision in the Plan or in the Agreement, if any provision of the Plan or the Agreement
contravenes any regulations or guidance promulgated under Section 409A of the Code or could cause
the Awards to be subject to additional taxes, accelerated taxation, interest or penalties under
Section 409A of the Code, the Company may, in its sole discretion and without your consent, modify
the Plan and/or the Agreement: (i) to comply with, or avoid being subject to, Section 409A of the
Code, or to avoid the imposition of any taxes, accelerated taxation, interest or penalties under
Section 409A of the Code, and (ii) to maintain, to the maximum extent practicable, the original
intent of the applicable provision without contravening the provisions of Section 409A of the Code.
This Section 11(d) does not create an obligation on the part of the Company to modify the Plan or
the Agreement and does not guarantee that the Award will not be subject to interest or penalties
under Section 409A of the Code.
12. Employment Conditions. In accepting the Award, you acknowledge that:
(a) Any notice period mandated under the laws of the local jurisdiction shall not be treated
as service for the purpose of determining the vesting of the Award; and your right to receive
shares of Common Stock in settlement of the Award after termination of service, if any, will be
measured by the date of termination of your status as an Employee and will not be extended by any
notice period mandated under the local law. Subject to the foregoing and the provisions of the
Plan, the Company, in its sole discretion, shall determine whether your status as an Employee has
terminated and the effective date of such termination.
(b) The vesting of the Award shall cease upon, and no portion of the Award shall become
vested following, your termination as an Employee for any reason except as may be explicitly
provided by the Plan or this Agreement.
(c) The Plan is established voluntarily by the Company. It is discretionary in nature and it
may be modified, amended, suspended or terminated by the Company at any time, unless otherwise
provided in the Plan and this Agreement. Unless otherwise provided by the
Plan or this Agreement, the unvested portion of the Award at the time of your termination as
an Employee will be forfeited.
(d) The grant of the Award is voluntary and occasional and does not create any contractual or
other right to receive future grants of Awards, or benefits in lieu of Awards, even if Awards have
been granted repeatedly in the past.
(e) All decisions with respect to future Award grants, if any, will be at the sole discretion
of the Company.
(f) You are voluntarily participating in the Plan.
(g) The Award is an extraordinary item that does not constitute compensation of any kind for
service of any kind rendered to the Company (or any Affiliate), and which is outside the scope of
your employment contract, if any. In addition, the Award is not part of normal or expected
compensation or salary for any purpose, including, but not limited to, calculating any severance,
resignation, termination, redundancy, end-of-service payments, bonuses, long-service awards,
pension or retirement benefits or similar payments.
(h) The future value of the underlying shares of Common Stock is unknown and cannot be
predicted with certainty. If you obtain shares upon settlement of the Award, the value of those
shares may increase or decrease.
(i) No claim or entitlement to compensation or damages arises from termination of the Award
or diminution in value of the Award or shares of Common Stock acquired upon settlement of the Award
resulting from termination of your status as an Employee (for any reason whether or not in breach
of the local law) and you irrevocably release the Company and each Affiliate from any such claim
that may arise. If, notwithstanding the foregoing, any such claim is found by a court of competent
jurisdiction to have arisen then, by signing this Agreement, you shall be deemed irrevocably to
have waived your entitlement to pursue such a claim.
13. Headings. The headings of the Sections in this Agreement are inserted for
convenience only and shall not be deemed to constitute a part of this Agreement or to affect the
meaning of this Agreement.
14. Severability. If all or any part of this Agreement or the Plan is
declared by any court or governmental authority to be unlawful or invalid, such unlawfulness or
invalidity will not invalidate any portion of this Agreement or the Plan not declared to be
unlawful or invalid. Any Section of this Agreement (or part of such a Section) so declared to be
unlawful or invalid will, if possible, be construed in a manner which will give effect to the terms
of such Section or part of a Section to the fullest extent possible while remaining lawful and
valid.
15. Amendment.
Nothing in this Agreement shall restrict the Companys ability to
exercise its discretionary authority pursuant to Section 3 of the Plan; provided, however, that no
such action may, without your consent, adversely affect your rights under your Award and this
Agreement.
16. Delivery of Documents and Notices. Any document relating to
participation in the Plan, or any notice required or permitted hereunder shall be given in writing
and shall be deemed effectively given (except to the extent that this Agreement provides for
effectiveness only upon actual receipt of such notice) upon personal delivery electronic delivery
at the e-mail address, if any, provided for you by the Company, or, upon deposit in the local
postal service, by registered or certified mail, or with a nationally recognized overnight courier
service with postage and fees prepaid, addressed to the other party at the address of such party
set forth in the Grant Notice or at such other address as such party may designate in writing from
time to time to the other party.
(a) The Plan documents, which may include but do not necessarily include: the Plan, this
Agreement, and any reports of the Company provided generally to the Companys shareholders, may be
delivered to you electronically. In addition, if permitted by the Company, you may deliver
electronically the notices called for under the Agreement or the Plan to the Company or to such
third party involved in administering the Plan as the Company may designate from time to time.
Such means of electronic delivery may include but do not necessarily include the delivery of a link
to a Company intranet or the internet site of a third party involved in administering the Plan, the
delivery of the document via e-mail or such other means of electronic delivery specified by the
Company.
(b) You acknowledge that you have read this Section 16 of this Agreement and consent to the
electronic delivery of the Plan documents and, if permitted by the Company, the delivery of the
notices, as described in the Agreement or the Plan. You acknowledge that you may receive from the
Company a paper copy of any documents delivered electronically at no cost to you by contacting the
Company by telephone or in writing. You further acknowledge that you will be provided with a paper
copy of any documents if the attempted electronic delivery of such documents fails. Similarly, you
understand that you must provide the Company or any designated third party administrator with a
paper copy of any documents if the attempted electronic delivery of such documents fails. You may
revoke your consent to the electronic delivery of documents described in this Section 16 or may
change the electronic mail address to which such documents are to be delivered (if you have
provided an electronic mail address) at any time by notifying the Company of such revoked consent
or revised e-mail address by telephone, postal service or electronic mail. Finally, you understand
that you are not required to consent to electronic delivery of documents described in this
Section 16.
17. Miscellaneous.
(a) The rights and obligations of the Company under your Award shall be transferable to any
one or more persons or entities, and all covenants and agreements hereunder shall inure to the
benefit of, and be enforceable by the Companys successors and assigns.
(b) You agree upon request to execute any further documents or instruments necessary or
desirable in the sole determination of the Company to carry out the purposes or intent of your
Award.
(c) You acknowledge and agree that you have reviewed your Award in its entirety, have had an
opportunity to obtain the advice of counsel prior to executing and accepting your Award and fully
understand all provisions of your Award.
18. Governing Plan Document. Your Award is subject to all the provisions of
the Plan, the provisions of which are hereby made a part of your Award, and is further subject to
all interpretations, amendments, rules and regulations which may from time to time be promulgated
and adopted pursuant to the Plan. In the event of any conflict between the provisions of your
Award and those of the Plan, the provisions of the Plan shall control.
19. Choice of Law. The interpretation, performance and enforcement of this
Agreement shall be governed by the law of the state of Delaware without regard to such states
conflicts of laws rules.
Exhibit 10.26
Exhibit 10.26
Nektar Therapeutics
201 Industrial Road
San Carlos, California 94070
December 1, 2008
Mr. Howard W. Robin
c/o Nektar Therapeutics
201 Industrial Road
San Carlos, California 94070
Dear Howard,
This letter agreement supersedes the offer letter agreement you entered into with Nektar
Therapeutics (Nektar or the Company) on January 5, 2007 and any other understandings and
agreements, written or oral, between you and the Company with respect to the subject matter herein
and is made effective as of the date set forth above. Capitalized terms used herein and not
defined shall have the meanings ascribed to them in the Companys Change of Control Severance
Benefit Plan, as it may be amended from time to time (the COC Plan a copy of which is included
herein).
As President and Chief Executive Officer, you shall have the general powers and duties of
management usually vested in the office of chief executive officer of a corporation of the size and
nature of Nektar. You shall report directly to the Board. The Chairman of the Board shall be a
non-executive chairman. Your principal place of employment will be 201 Industrial Road, San Carlos,
CA.
Your annual cash compensation will consist of two components: base salary and an annual
performance bonus. Your base salary will be $680,000 on an annual basis and paid in accordance with
Nektars regular payroll schedule. Your annual performance bonus target each year will be at least
65% of your annual base salary (Target Annual Bonus). Your base salary and Target Annual Bonus
shall be subject to an annual performance review by the Board for appropriate upward adjustment.
The actual amount of your annual performance bonus will range from 0% to 200% of the Target Annual
Bonus based on the Boards assessment of your achievement of a combination of corporate and
personal objectives agreed upon by you and the Board at the beginning of each annual performance
period. Your annual performance bonus for a particular year will be paid not later than March 15 of
the following year.
You will be eligible for annual equity awards, in the sole discretion of the Board, based on
the Boards review of your individual performance and annual equity compensation levels of
non-founder chief executive officers of comparator companies as analyzed by a reputable,
nationally-recognized, independent compensation consultancy firm.
You will also be eligible to participate in Nektars executive benefits program including
medical, dental and vision insurance, term life insurance, 401(k), the flexible health spending
plan, short & long-term disability upon the terms specified in those plans, and the COC Plan.
Your employment is by continued mutual agreement and may be terminated at will with or without
cause by either you or Nektar at any time with or without advanced notice.
In the event that your employment terminates due to your death or Disability (as defined in
the Companys 2000 Equity Incentive Plan), (a) 50% of the then-unvested portion of any outstanding
stock options granted to you by the Company will automatically vest in the event of your Disability
(with the remainder of such unvested portion terminating immediately thereafter), and 100% of the
then-unvested portion of any outstanding stock options granted to you by the Company shall
automatically vest in the event of your death, (b) Nektar will pay to you or your estate, as
applicable, all unreimbursed expenses, all of your then accrued but unpaid base salary, and your
target bonus prorated for the portion of the last year in which you were employed by Nektar prior
to death or Disability, and (c) you and your dependents shall be entitled to continued medical,
dental, and vision insurance, at your or their expense, at the same level of coverage as was
provided to you and your dependents under Nektars insurance and benefits plans immediately prior
to the termination by electing COBRA continuation coverage in accordance with applicable law.
In the event your employment is terminated for reasons not related to a Change of Control
(a) by the Company without Cause, or (b) by you for a Good Reason Resignation, then you and the
Company will meet in good faith to discuss the terms of an appropriate separation. In any event, at
a minimum, the Company will enter into a severance arrangement with you which will include the
following: (i) a fully effective mutual waiver and release in such form as the Company may
reasonably require, (ii) a cash severance payment equal to your total annual cash compensation
target (defined as your current monthly base salary annualized for 12 months, plus your then
effective bonus target multiplied by the expected pay-out percentage used by the Company for its
GAAP financial statements in the previous calendar quarter, but not to exceed 100%), payable in
accordance with the severance payment schedule described in Section 4.2 of the COC Plan (including,
without limitation and as applicable, the six-month delay for payments to specified employees as
set forth in such section), (iii) the exercise period for any stock options granted to you by the
Company that are outstanding and vested as of your termination date shall be 18 months following
the termination date (subject to earlier termination at the end of the option term or in connection
with a change in control of the Company in accordance with the applicable option plan and
agreement), and (iv) the Company shall pay all applicable COBRA payments for you and your family
for one year after the termination date (such payments shall cease in the event that you become
eligible for comparable benefits with another employer).
Any reimbursements pursuant to the foregoing provisions of this offer letter shall be made in
accordance with the Companys reimbursement policies, practices and procedures in effect from time
to time and shall be paid as soon as reasonably practicable and in all events not later than the
end of the calendar year following the year in which the related expense
was incurred. Your rights to reimbursement hereunder are not subject to liquidation or
exchange for another benefit and the amount of expenses eligible for reimbursement in one calendar
year shall not affect the amount of expenses eligible for reimbursement in any other year.
2
The terms, compensation and benefits set forth in this letter, which shall be governed by
California law, without reference to principles of conflicts of laws, may not be reduced without
your prior written consent and shall be binding upon and inure to the benefit of (a) your heirs,
executors, and legal representatives upon your death and (b) any person or entity which at any
time, whether by purchase, merger, or otherwise, directly or indirectly acquires all or a majority
of the assets, business, capital stock, or voting stock of the Nektar. Any such person or entity
shall be deemed substituted for the Nektar under this letter for all purposes.
Howard, on behalf of the Board, I am delighted at the prospect of your continued leadership at
Nektar as the President and Chief Executive Officer.
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Sincerely, |
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/s/ Michael A. Brown |
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Michael A. Brown |
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Chairman, Organization and Compensation Committee of the Board of Directors
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AGREED AND ACCEPTED: |
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/s/ Howard W. Robin |
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3
Filed by Bowne Pure Compliance
Exhibit 10.27
Nektar Therapeutics
201 Industrial Road
San Carlos, California 94070
December 1, 2008
John Nicholson
c/o Nektar Therapeutics
201 Industrial Road
San Carlos, California 94070
Dear John:
I present you with this amended and restated version of your offer letter agreement setting
forth certain terms and conditions of your continued employment in the position of Senior Vice
President and Chief Financial Officer at Nektar Therapeutics (Nektar or the
Company) reporting directly to me. Capitalized terms used herein and not defined shall
have the meanings ascribed to them in the Companys Change of Control Severance Benefit Plan, as it
may be amended from time to time (the COC Plan a copy of which is enclosed herewith).
This offer letter agreement supersedes the offer letter agreement you entered into with Nektar on
December 10, 2007 and any other understandings and agreements, written or oral, between you and the
Company with respect to the subject matter herein and is made effective as of the first date set
forth above.
Your annual cash compensation will consist of two components: base salary and an annual
performance bonus. Your base salary will be $425,000 on an annual basis and paid in accordance
with Nektars regular payroll schedule. Your annual performance bonus target each year will be at
least 50% of your annual base salary for each annual period (Target Annual Bonus). Your
base salary and Target Annual Bonus shall be subject to annual performance review by the
Compensation Committee of the Board of Directors (Compensation Committee) in consultation
with me for appropriate upward adjustment. The actual amount of your annual performance bonus will
range from 0% to 200% of the Target Annual Bonus based on the Compensation Committees assessment
in consultation with me of the achievement of a combination of annual corporate objectives and your
achievement of personal objectives agreed upon by you and me at the beginning of each annual
performance period. Your annual performance bonus for a particular year will be paid not later
than March 15 of the following year.
You will be eligible for annual equity awards, in the sole discretion of the Compensation
Committee, based on the Compensation Committees review, in consultation with me, of your
individual performance and annual equity compensation levels of senior executive officers with
similar roles at comparator companies as analyzed by a reputable, nationally-recognized,
independent compensation consultancy firm.
Commencing with your first day of employment, you and your family will be eligible to
participate in Nektars executive benefits program including medical, dental and vision insurance,
term life insurance, 401(k), the flexible health spending plan, short & long-term disability upon
the terms specified in those plans, and the COC Plan. There will be no restrictions that will
limit you or your familys participation in Nektars medical insurance plan.
Nektar will also provide you with the following additional benefits related to your relocation
to the San Francisco Bay Area from your current home in Parsippany, New Jersey (New Jersey
Home):
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(1) |
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Reimbursement for normal and customary closing costs actually incurred on the
sale of your New Jersey Home including but not limited to up to a 6% real estate sales
commission. Closing costs not considered deductible by you for tax purposes will be
grossed up and added to those costs that are considered deductible (which will be
subject to standard withholding). |
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(2) |
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Reimbursement for normal and customary closing costs actually incurred in
connection with the purchase of a home in the San Francisco Bay Area (California
Home) including but not limited to up to 3% of the loan amount for
points/commission etc. Closing costs not considered deductible by you for tax purposes
will be grossed up and added to those costs that are considered deductible (which
will be subject to standard withholding). |
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(3) |
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Reimbursement for shipment of your household goods from your New Jersey Home to
your California Home. |
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(4) |
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Reimbursement for temporary housing for you in the San Francisco Bay Area and
reasonable expenses incurred in connection therewith through December 31, 2009, and
this benefit will be provided to you on a grossed up basis if determined to be
taxable to you. |
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(5) |
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Nektar will reimburse you for your reasonable travel expenses to and from
Northern California and your New Jersey Home prior to your familys relocation to your
California Home. |
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(6) |
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Following your relocation to California, you will then be entitled to a
one-time relocation bonus of $75,000 on grossed up basis (i.e. the total you receive
after applicable withholding will be $75,000). |
Your employment is by continued mutual agreement and may be terminated at will with or without
cause by either you or Nektar at any time with or without advanced notice. You have also entered
into Nektars standard Employment Agreement and such agreement contains certain terms and
conditions of your employment with Nektar other than those set forth herein.
2
In the event that your employment terminates due to your death or Disability (as defined in
the Companys 2000 Equity Incentive Plan), (a) 50% of the then-unvested portion of any outstanding
stock options granted to you by the Company will automatically vest in the event of your Disability
(with the remainder of such unvested portion terminating immediately thereafter), and 100% of the
then-unvested portion of any outstanding stock options granted to you by the Company shall
automatically vest in the event of your death, (b) Nektar will pay to you or your estate, as
applicable, all unreimbursed expenses, all of your then accrued but unpaid base salary, and your
target bonus prorated for the portion of the last year in which you were employed by Nektar prior
to death or Disability, and (c) you and your dependents shall be entitled to continued medical,
dental, and vision insurance, at your or their expense, at the same level of coverage as was
provided to you and your dependents under Nektars insurance and benefits plans immediately prior
to the termination by electing COBRA continuation coverage in accordance with applicable law.
In the event your employment is terminated for reasons not related to a Change of Control (a)
by the Company without Cause, or (b) by you for a Good Reason Resignation, then you and the Company
will meet in good faith to discuss the terms of an appropriate separation. In any event, at a
minimum, the Company will enter into a severance arrangement with you which will include the
following: (i) a fully-effective mutual waiver and release in such form as the Company may
reasonably require, (ii) a cash severance payment equal to your total annual cash compensation
target (defined as your current monthly base salary annualized for 12 months, plus your bonus
target multiplied by the expected pay-out percentage used by the Company for its GAAP financial
statements in the previous calendar quarter, but not to exceed 100%), payable in accordance with
the severance payment schedule described in Section 4.2 of the COC Plan (including, without
limitation and as applicable, the six-month delay for payments to specified employees as set
forth in such section), (iii) if the termination of your employment occurs prior to the first
anniversary of your employment commencement date (the Start Date), pro-rata vesting
credit on your stock option granted by the Company on your Start Date through the date of
termination, based on the number of months of employment with the Company completed since your
Start Date, (iv) the exercise period for the portion of your outstanding stock options that are
vested as of your termination date shall be 12 months following the termination date (subject to
earlier termination at the end of the option term or in connection with a change in control of the
Company in accordance with the applicable option plan and agreement), and (v) the Company shall pay
all applicable COBRA payments for you and your family for one year
after the termination date (such payments shall cease in the event that you become eligible
for comparable benefits with another employer).
Any reimbursements pursuant to the foregoing provisions of this offer letter shall be made in
accordance with the Companys reimbursement policies, practices and procedures in effect from time
to time and shall be paid as soon as reasonably practicable and in all events not later than the
end of the calendar year following the year in which the related expense was incurred. Your rights
to reimbursement hereunder are not subject to liquidation or exchange for another benefit and the
amount of expenses eligible for reimbursement in one calendar year shall not affect the amount of
expenses eligible for reimbursement in any other year. Any tax gross-up payments made pursuant to
the foregoing provisions of this offer letter shall be made as soon as practicable and in all
events not later than the end of the calendar year following the year in which you remit the
related taxes.
3
The terms, compensation and benefits set forth in this letter, which shall be governed by
California law, without reference to principles of conflicts of laws, may not be reduced without
your prior written consent and shall be binding upon and inure to the benefit of (a) your heirs,
executors, and legal representatives upon your death and (b) any person or entity which at any
time, whether by purchase, merger, or otherwise, directly or indirectly acquires all or a majority
of the assets, business, capital stock, or voting stock of Nektar. Any such person or entity shall
be deemed substituted for Nektar under this letter for all purposes.
John, I am delighted at the prospect of your continued leadership at Nektar as Senior Vice
President and Chief Financial Officer.
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Sincerely,
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/s/ Howard W. Robin
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Howard W. Robin |
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President and Chief Executive Officer |
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ACCEPTED:
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/s/ John Nicholson
John Nicholson
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4
Filed by Bowne Pure Compliance
Exhibit 10.28
Nektar Therapeutics
201 Industrial Road
San Carlos, California 94070
December 1, 2008
Bharatt M. Chowrira. Ph.D., J.D.
c/o Nektar Therapeutics
201 Industrial Road
San Carlos, California 94070
Dear Bharatt:
I present you with this amended and restated version of your offer letter agreement setting
forth certain terms and conditions of your continued employment in the position of Senior Vice
President and Chief Operating Officer at Nektar Therapeutics (Nektar or the
Company) reporting directly to me and in the position of Chairman of Nektar India.
Capitalized terms used herein and not defined shall have the meanings ascribed to them in the
Companys Change of Control Severance Benefit Plan, as it may be amended from time to time (the
COC Plan a copy of which is enclosed herewith). This offer letter agreement supersedes
the offer letter agreement you entered into with Nektar on May 13, 2008, and any other
understandings and agreements, written or oral, between you and the Company with respect to the
subject matter herein and is made effective as of the date set forth above.
As Chief Operating Officer, you shall have the general powers and duties of management usually
vested in the office of chief operating officer of a corporation of the size and nature of Nektar.
Your principal place of employment will be 201 Industrial Road, San Carlos, California.
Your annual cash compensation will consist of two components: base salary and an annual
performance bonus. Your base salary will be $475,000 on an annual basis and paid in accordance
with Nektars regular payroll schedule. Your annual performance bonus target each year will be at
least 60% of your annual base salary for each annual period and shall be $285,000 in 2008 and not
pro-rated for your partial period of service in 2008 (Target Annual Bonus). Your base
salary and Target Annual Bonus shall be subject to annual performance review by the Compensation
Committee of the Board of Directors (Compensation Committee) in consultation with me for
appropriate upward adjustment. The actual amount of your annual performance bonus will range from
0% to 200% of the Target Annual Bonus based on the Compensation Committees assessment in
consultation with me of the achievement of a combination of annual corporate objectives and your
achievement of personal objectives agreed upon by you and me at the beginning of each annual
performance period; provided that your
objectives for your partial period of service in 2008 will be agreed upon by you and I as soon
as practicable following your first day of full-time employment with the Company (the Start
Date). Your annual performance bonus for a particular year will be paid not later than March
15 of the following year.
You will be eligible for annual equity awards, in the sole discretion of the Compensation
Committee, based on the Compensation Committees review, in consultation with me, of your
individual performance and annual equity compensation levels of senior executive officers with
similar roles at comparator companies as analyzed by a reputable, nationally-recognized,
independent compensation consultancy firm.
You will be eligible to participate in Nektars executive benefits program including medical,
dental and vision insurance, term life insurance, 401(k), the flexible health spending plan, short
& long-term disability upon the terms specified in those plans, and the COC Plan in accordance with
the terms of those programs.
Your employment is by continued mutual agreement and may be terminated at will with or without
cause by either you or Nektar at any time with or without advanced notice. You have also entered
into Nektars standard Employment Agreement and such agreement contains certain terms and
conditions of your employment with Nektar other than those set forth herein.
In the event that your employment terminates due to your death or Disability (as defined in
the Companys 2000 Equity Incentive Plan), (a) 50% of the then-unvested portion of any outstanding
stock options granted to you by the Company will automatically vest in the event of your Disability
(with the remainder of such unvested portion terminating immediately thereafter), and 100% of the
then-unvested portion of any outstanding stock options granted to you by the Company shall
automatically vest in the event of your death, (b) Nektar will pay to you or your estate, as
applicable, all unreimbursed expenses, all of your then accrued but unpaid base salary, and your
target bonus prorated for the portion of the last year in which you were employed by Nektar prior
to death or Disability, and (c) you and your dependents shall be entitled to continued medical,
dental, and vision insurance, at your or their expense, at the same level of coverage as was
provided to you and your dependents under Nektars insurance and benefits plans immediately prior
to the termination by electing COBRA continuation coverage in accordance with applicable law.
In the event your employment is terminated for reasons not related to a Change of Control (a)
by the Company without Cause, or (b) by you for a Good Reason Resignation, then you and the Company
will meet in good faith to discuss the terms of an appropriate separation. In any event, at a
minimum, the Company will enter into a severance arrangement with you which will include the
following: (i) a fully effective waiver and release in such form as the Company may reasonably
require, (ii) a cash severance payment equal to your total annual cash compensation target (defined
as your current monthly base salary annualized for 12 months, plus your bonus target multiplied by
the expected pay-out percentage used by the Company for its GAAP financial statements in the
previous calendar quarter, but not to exceed 100%), payable in accordance with the severance
payment schedule described in Section 4.2 of the COC Plan
(including, without limitation and as applicable, the six-month delay for payments to
specified employees as set forth in such section), (iii) if the termination of your employment
occurs prior to the first anniversary of your Start Date, pro-rata vesting credit on your stock
option granted by the Company on your Start Date through the date of termination, based on the
number of months of employment with the Company completed since your Start Date, (iv) the exercise
period for the portion of your outstanding stock options that are vested as of your termination
date shall be 18 months following the termination date (subject to earlier termination at the end
of the option term or in connection with a change in control of the Company in accordance with the
applicable option plan and agreement), and (v) the Company shall pay all applicable COBRA payments
for you and your family for one year after the termination date (such payments shall cease in the
event that you become eligible for comparable benefits with another employer).
2
Any reimbursements pursuant to the foregoing provisions of this offer letter shall be made in
accordance with the Companys reimbursement policies, practices and procedures in effect from time
to time and shall be paid as soon as reasonably practicable and in all events not later than the
end of the calendar year following the year in which the related expense was incurred. Your rights
to reimbursement hereunder are not subject to liquidation or exchange for another benefit and the
amount of expenses eligible for reimbursement in one calendar year shall not affect the amount of
expenses eligible for reimbursement in any other year.
The terms, compensation and benefits set forth in this letter, which shall be governed by
California law, without reference to principles of conflicts of laws, may not be reduced without
your prior written consent and shall be binding upon and inure to the benefit of (a) your heirs,
executors, and legal representatives upon your death and (b) any person or entity which at any
time, whether by purchase, merger, or otherwise, directly or indirectly acquires all or a majority
of the assets, business, capital stock, or voting stock of the Nektar. Any such person or entity
shall be deemed substituted for the Nektar under this letter for all purposes.
Bharatt, I am delighted at the prospect of your continued leadership at Nektar as Chief
Operating Officer and Head of the PEGylation Business Unit.
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Sincerely,
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/s/ Howard W. Robin
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Howard W. Robin |
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President and Chief Executive Officer |
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ACCEPTED:
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/s/ Bharatt M. Chowrira
Bharatt M. Chowrira
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3
Filed by Bowne Pure Compliance
Exhibit 10.29
Nektar Therapeutics
201 Industrial Road
San Carlos, California 94070
December 1, 2008
Randall W. Moreadith, M.D.
c/o Nektar Therapeutics
201 Industrial Road
San Carlos, California 94070
Dear Randall,
I present you with this amended and restated version of your offer letter agreement (the
Letter Agreement) setting forth certain terms and conditions of your continued employment
in the position of Senior Vice President, Drug Development and Chief Development Officer at Nektar
Therapeutics (Nektar or the Company), reporting to me. Capitalized terms used herein and not
defined shall have the meanings ascribed to them in the Companys Change of Control Severance
Benefit Plan, as it may be amended from time to time (the COC Plan a copy of which is
enclosed herewith). This Letter Agreement supersedes the offer letter agreement you entered into
with Nektar on July 28, 2008 and any other understandings and agreements, written or oral, between
you and the Company with respect to the subject matter herein and is made effective as of the date
set forth above.
Your annual cash compensation will consist of two components: base salary and an annual
performance bonus. Your base salary will be $425,000 on an annual basis and paid in accordance
with Nektars regular payroll schedule. Your annual performance bonus target each year will be at
least 60% of your annual base salary for each annual period and shall be $255,000 in 2008 and not
pro-rated for your partial period of service in 2008 (Target Annual Bonus). Your base
salary and Target Annual Bonus shall be subject to annual performance review by the Compensation
Committee of the Board of Directors (Compensation Committee) in consultation with me.
The actual amount of your annual performance bonus will range from 0% to 200% of the Target Annual
Bonus based on the Compensation Committees assessment in consultation with me of the achievement
of a combination of annual corporate objectives and your achievement of personal objectives agreed
upon by you and me at the beginning of each annual performance period; provided that your
objectives for your partial period of service in 2008 will be agreed upon by you and I as soon as
practicable following your first day of full time employment (the Start Date). Your
annual performance bonus for a particular year will be paid not later than March 15 of the
following year.
In connection with your commencing employment with the Company, the Company agreed to pay you
a sign-on bonus of $35,000, payable to you in your first paycheck following your Start Date and
such amount has been paid to you. We also agreed to pay the ordinary income taxes due on the
sign-on bonus, payable directly to the appropriate taxing authorities as and when these amounts
become due, but in no event later than April 15 of the year following the year in which
the sign-on bonus was paid. If, before the first anniversary of your Start Date, your employment
is terminated by the Company for Cause or if you resign other than for a Good Reason Resignation,
then you agree to reimburse Nektar for the full amount of this sign-on bonus within 30 days.
You are also eligible to participate in Nektars standard employee benefits programs including
Medical, Dental and Vision Insurance, Term Life Insurance, 401(k), ESPP, Flexible Health Spending
Account, Short & Long Term Disability, COC Plan and the terms specified in those plans.
Nektar also agreed to reimburse you for reasonable expenses incurred in connection with the
following (collectively, the Relocation Expenses):
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Shipment of your household goods from Solano Beach, California to the San Francisco Bay
Area. |
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Subject to your continued employment through the first anniversary of your Start Date,
we will pay you $5,000 per month (subject to applicable tax withholdings) for the first 12
months of your employment to cover the cost of housing in the San Francisco Bay Area, such
amount to be paid to you each pay period (15th and 30th of the month)
on a prorata basis. (The cost of this housing is taxable to you and will be included in
your total W-2 income). |
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Travel expenses for you to the San Francisco Bay Area. |
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Use of a rental car for up to 14 days after your Start Date or until your car arrives. |
The Company has also agreed that you would receive a relocation allowance of $10,000
(Relocation Allowance), to paid to you in your first paycheck and such amount has already
been paid to you. This amount is subject to standard payroll withholding and deductions. If,
before the first anniversary of your Start Date, your employment is terminated by the Company for
Cause or if you resign other than for a Good Reason Resignation, you agree to reimburse the Company
for the full amount of the Relocation Expenses and Relocation Allowance within 30 days of your
temployment termination date.
2
The Company also agreed to provide you with the following relocation assistance benefits if
you purchase a home in the San Francisco Bay Area before the first anniversary of your Start Date
(collectively, the Housing Transaction Costs):
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Provide normal and customary closing costs on the sale of your home. Those items
considered not deductible for income tax purposes will be grossed up and added to those
costs considered deductible (this portion is subject to standard payroll withholding and
deductions). In no event will we reimburse you for more than 6% of the sale price. |
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Provide normal and customary single-family home purchase closing costs and loan discount
points (not to exceed 1%). Those items considered not deductible for income tax purposes
will be grossed up and added to those costs considered deductible (this portion is
subject to standard payroll withholding and deductions). In no event will we reimburse you
for more than 3% of the purchase price. |
If, before your first anniversary of your Start Date, your employment is terminated by the
Company for Cause or if you resign other than for a Good Reason Resignation, you agree to reimburse
Nektar for the full amount of the Housing Transaction Costs within 30 days.
Your employment is by continued mutual agreement and may be terminated at will with or without
cause by either you or Nektar at any time with or without advanced notice. You have also entered
into Nektars standard Employment Agreement and such agreement contains certain terms and
conditions of your employment with Nektar other than those set forth herein.
In the event that your employment terminates due to your death or Disability (as defined in
the Companys 2000 Equity Incentive Plan), (a) 50% of the then-unvested portion of any outstanding
stock options granted to you by the Company will automatically vest in the event of your Disability
(with the remainder of such unvested portion terminating immediately thereafter), and 100% of the
then-unvested portion of any outstanding stock options granted to you by the Company shall
automatically vest in the event of your death, (b) Nektar will pay to you or your estate, as
applicable, all unreimbursed expenses, all of your then accrued but unpaid base salary, and your
target bonus prorated for the portion of the last year in which you were employed by Nektar prior
to death or Disability, and (c) you and your dependents shall be entitled to continued medical,
dental, and vision insurance, at your or their expense, at the same level of coverage as was
provided to you and your dependents under Nektars insurance and benefits plans immediately prior
to the termination by electing COBRA continuation coverage in accordance with applicable law.
3
In the event your employment is terminated for reasons not related to a Change of Control (a)
by the Company without Cause, or (b) by you for a Good Reason Resignation, then you and the Company
will meet in good faith to discuss the terms of an appropriate separation. In any event, at a
minimum, the Company will enter into a severance arrangement with you which will include the
following: (i) a fully effective waiver and release in such form as the Company may reasonably
require, (ii) a cash severance payment equal to your total annual cash compensation target (defined
as your current monthly base salary annualized for 12 months, plus your bonus target multiplied by
the expected pay-out percentage used by the Company for its GAAP financial statements in the
previous calendar quarter, but not to exceed 100%), payable in accordance with the severance
payment schedule described in Section 4.2 of the COC Plan
(including, without limitation and as applicable, the six-month delay for payments to
specified employees as set forth in such section), (iii) the exercise period for the portion of
your outstanding stock options that are vested as of your termination date shall be 12 months
following the termination date (subject to earlier termination at the end of the option term or in
connection with a change in control of the Company in accordance with the applicable option plan
and agreement), and (iv) the Company shall pay all applicable COBRA payments for you and your
family for one year after the termination date (such payments shall cease in the event that you
become eligible for comparable benefits with another employer).
Any reimbursements pursuant to the foregoing provisions of this Letter Agreement shall be made
in accordance with the Companys reimbursement policies, practices and procedures in effect from
time to time and shall be paid as soon as reasonably practicable and in all events not later than
the end of the calendar year following the year in which the related expense was incurred. Your
rights to reimbursement hereunder are not subject to liquidation or exchange for another benefit
and the amount of expenses eligible for reimbursement in one calendar year shall not affect the
amount of expenses eligible for reimbursement in any other year. Any tax gross-up payments made
pursuant to the foregoing provisions of this Letter Agreement shall be made as soon as practicable
and in all events not later than the end of the calendar year following the year in which you remit
the related taxes.
The terms, compensation and benefits set forth in this Letter Agreement shall be governed by
California law without reference to principles of conflicts of laws, may not be reduced without
your prior written consent and shall be binding upon and inure to the benefit of (a) your heirs,
executors, and legal representatives upon your death and (b) any person or entity which at any
time, whether by purchase, merger, or otherwise, directly or indirectly acquires all or a majority
of the assets, business, capital stock, or voting stock of Nektar. Any such person or entity shall
be deemed substituted for Nektar under this Letter Agreement for all purposes.
The compensation and benefits payable hereunder are intended to either be exempt from or
comply with Section 409A of the Internal Revenue Code of 1986, as amended (Section 409A),
so as not to subject you to payment of any additional tax, penalty or interest imposed under
Section 409A. The provisions of this offer letter shall be construed and interpreted to avoid the
imputation of any such additional tax, penalty or interest under Section 409A yet preserve (to the
nearest extent reasonably possible) the intended benefit payable you.
4
Randall, we are delighted at the prospect of your continued leadership as a key member of
Nektars executive team.
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Sincerely,
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/s/ Howard W. Robin
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Howard W. Robin |
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President and Chief Executive Officer |
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ACCEPTED:
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/s/ Randall W. Moreadith
Randall W. Moreadith
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5
Exhibit 10.34
Exhibit 10.34
FOIA CONFIDENTIAL TREATMENT REQUESTED
EXCLUSIVE RESEARCH, DEVELOPMENT,
LICENSE AND MANUFACTURING
AND SUPPLY AGREEMENT
BY AND AMONG
NEKTAR THERAPEUTICS AL, CORPORATION
AND
BAXTER HEALTHCARE SA
AND
BAXTER HEALTHCARE CORPORATION
DATED SEPTEMBER 26, 2005
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[***] |
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indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
TABLE OF CONTENTS
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1. DEFINITIONS |
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2 |
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2. RESEARCH AND DEVELOPMENT ACTIVITIES |
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16 |
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2.1 OVERVIEW |
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16 |
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2.2 NEKTAR AL PAYMENTS |
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17 |
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2.3 MARKETING AUTHORIZATION |
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18 |
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2.4 MATERIALS |
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18 |
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2.5 HANDLING |
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20 |
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2.6 SELECTION OF POTENTIAL PRODUCTS AND [***] |
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20 |
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2.7 DISCLAIMER OF WARRANTY WITH RESPECT TO BAXTER MATERIALS |
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20 |
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3. GOVERNANCE |
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21 |
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3.1 JOINT STEERING COMMITTEE |
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21 |
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3.2 RESEARCH COMMITTEE |
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23 |
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3.3 DEVELOPMENT AND PRODUCTION COMMITTEE |
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25 |
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3.4 AMENDMENT; WAIVER |
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25 |
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[***] |
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indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
-ii-
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Page |
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4. LICENSES TO NEKTAR AL LICENSED TECHNOLOGY AND BAXTER TECHNOLOGY |
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26 |
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4.1 LICENSE TO BAXTER |
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26 |
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4.2 TERMS OF SUBLICENSE |
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26 |
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4.3 NEKTAR AL RESEARCH RIGHTS AND LIMITATIONS |
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27 |
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4.4 NO IMPLIED RIGHTS OR LICENSES |
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28 |
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4.5 LICENSE TO NEKTAR AL |
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28 |
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4.6 MUTUAL COVENANT |
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28 |
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5. MANUFACTURE AND SUPPLY OF SELECTED REAGENTS |
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29 |
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5.1 [***] |
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29 |
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5.2 SUPPLY PRIOR TO PIVOTAL TRIAL/SUPPLY AGREEMENT |
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29 |
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5.3 PIVOTAL TRIAL AND COMMERCIAL PRODUCT SUPPLY AGREEMENT |
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30 |
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6. SPECIFICATIONS AND MANUFACTURING WARRANTY FOR SELECTED REAGENTS |
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31 |
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6.1 SPECIFICATIONS |
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31 |
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6.2 COMPLIANCE AUDITS |
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31 |
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6.3 WARRANTY |
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31 |
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6.4 DISCLAIMER OF WARRANTY |
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32 |
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[***] |
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indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
-iii-
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Page |
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7. EXCLUSIVITY; [***] |
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33 |
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7.1 NEKTAR AL |
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33 |
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7.2 BAXTER |
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33 |
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8. QUALITY AND COMPLAINTS |
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34 |
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8.1 ANALYSIS |
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34 |
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8.2 ACCEPTANCE AND REJECTION |
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35 |
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8.3 REPLACEMENT OF NONCONFORMING REAGENT |
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36 |
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8.4 LIABILITY TO BAXTER FOR NONCONFORMING REAGENT |
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36 |
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8.5 [INTENTIONALLY OMITTED] |
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37 |
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8.6 FEES FOR MANUFACTURING AND SUPPLY OF SELECTED REAGENTS PRIOR TO PIVOTAL TRIAL |
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37 |
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9. MILESTONES; ROYALTY PAYMENTS; ROYALTY REPORTS |
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39 |
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9.1 MILESTONE PAYMENTS |
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39 |
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9.2 ROYALTIES |
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42 |
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9.3 SEPARATE COMPONENTS |
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45 |
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9.4 COMMERCIAL DILIGENCE |
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45 |
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9.5 REPORTS, EXCHANGE RATES |
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46 |
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9.6 THIRD PARTY ROYALTIES, ETC |
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47 |
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[***] |
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indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
-iv-
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Page |
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10. RECORDS; AUDITS; SHIPMENT TERMS; PAYMENT TERMS |
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47 |
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10.1 RECORDS |
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47 |
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10.2 AUDITS |
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48 |
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10.3 INVOICING; PAYMENT TERMS |
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49 |
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10.4 PAYMENT METHOD |
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49 |
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10.5 TAXES |
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49 |
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11. CONFIDENTIALITY |
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50 |
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11.1 TERMINATION OF NON-DISCLOSURE AGREEMENT |
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50 |
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11.2 IN GENERAL |
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50 |
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11.3 ADDITIONAL PROTECTIONS |
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52 |
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11.4 PERMITTED DISCLOSURES |
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52 |
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11.5 IRREPARABLE INJURY |
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53 |
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12. REGULATORY MATTERS |
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53 |
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12.1 COMPLAINTS/ADVERSE EVENTS |
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53 |
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12.2 SPECIFIC REQUIREMENTS |
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53 |
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13. REPRESENTATIONS & WARRANTIES; COVENANTS |
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54 |
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13.1 REPRESENTATIONS AND WARRANTIES |
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54 |
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13.2 COMPLIANCE WITH LAWS |
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54 |
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[***] |
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indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
-v-
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Page |
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14. LIMITATION OF LIABILITY; EXCLUSION OF DAMAGES |
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55 |
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14.1 LIMITATION OF LIABILITY |
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55 |
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14.2 REMEDIES |
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55 |
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14.3 APPLICABILITY, EXCLUSIVITY OF REMEDIES |
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56 |
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15. INDEMNIFICATION; INSURANCE |
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56 |
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15.1 INDEMNITY |
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56 |
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15.2 INSURANCE |
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57 |
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15.3 PROCEDURES |
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57 |
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16. INVENTIONS, KNOW-HOW AND PATENTS |
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59 |
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16.1 EXISTING INTELLECTUAL PROPERTY |
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59 |
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16.2 DISCLOSURE |
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59 |
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16.3 OWNERSHIP OF INVENTIONS |
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59 |
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16.4 NEKTAR AL CORE TECHNOLOGY INVENTIONS |
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60 |
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16.5 BAXTER CORE TECHNOLOGY INVENTIONS |
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61 |
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16.6 INDIVIDUAL PATENT FILINGS |
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61 |
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16.7 JOINT PATENT FILINGS |
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62 |
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16.8 DISPOSITION OF INVENTIONS |
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62 |
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16.9 FURTHER ACTIONS |
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63 |
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16.10 PATENT MARKING AND POTENTIAL PRODUCT AND
COMMERCIAL PRODUCT MARKING |
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63 |
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16.11 SUPPLEMENTAL PATENT PROTECTION |
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63 |
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[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
-vi-
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Page |
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17. INFRINGEMENT |
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64 |
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17.1 INFRINGEMENT OF THIRD PARTY RIGHTS |
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64 |
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17.2 INFRINGEMENT BY THIRD PARTIES |
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65 |
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18. [INTENTIONALLY OMITTED] |
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67 |
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19. TERM AND TERMINATION |
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67 |
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19.1 EXPIRATION |
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67 |
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19.2 DISCRETIONARY TERMINATION |
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67 |
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19.3 TERMINATION FOR CAUSE |
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68 |
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19.4 TERMINATION FOR INSOLVENCY |
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68 |
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19.5 TERMINATION/[***] FOR LACK OF
DILIGENCE |
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68 |
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19.6 TERMINATION ON CHALLENGE |
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71 |
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19.7 EFFECT OF TERMINATION |
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71 |
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[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
-vii-
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20. ASSIGNMENT |
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74 |
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21. NOTICES |
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74 |
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22. MISCELLANEOUS |
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76 |
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22.1 FORCE MAJEURE |
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76 |
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22.2 SEVERABILITY |
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77 |
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22.3 VARIATION |
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77 |
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22.4 FORBEARANCE AND WAIVER |
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77 |
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22.5 COUNTERPARTS; FACSIMILE |
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77 |
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22.6 NO PARTNERSHIP |
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78 |
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22.7 CONSTRUCTION |
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78 |
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22.8 ENTIRE AGREEMENT |
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78 |
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22.9 GOVERNING LAW |
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79 |
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22.10 PUBLICITY |
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79 |
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[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
-viii-
TABLE OF CONTENTS
(continued)
|
SCHEDULE I RESEARCH PLAN |
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SCHEDULE II MILESTONES |
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SCHEDULE III QUALITY AGREEMENT |
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SCHEDULE IV BAXTER DE ELOPMENT DILIGENCE TIMELINES |
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SCHEDULE V TERMS AND CONDITIONS OF SUPPLY AGREEMENT |
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SCHEDULE VI MANUFACTURING COST |
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SCHEDULE VII PERMITTED ACTIVITIES |
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EXHIBIT 1 BAXTER RESEARCH PLAN |
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[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
-ix-
EXCLUSIVE RESEARCH, DEVELOPMENT, AND LICENSE
AGREEMENT
This Agreement (this AGREEMENT) is made and entered into as of September 26, 2005 (the EFFECTIVE
DATE) by and among Nektar Therapeutics AL, Corporation, an Alabama corporation, having its
principal place of business at 490 Discovery Drive, Huntsville, AL 35806 (NEKTAR AL), Baxter
Healthcare SA (BHSA), a corporation organized and existing under the laws of Switzerland, and
Baxter Healthcare Corporation (BHC), a Delaware corporation, having its principal place of
business at One Baxter Parkway, Deerfield, Illinois 60015 (BHSA and BHC collectively referred to as
BAXTER). NEKTAR AL and BAXTER may be referred to herein individually as a PARTY and
collectively as the PARTIES.
RECITALS
WHEREAS, BAXTER is in the business of developing, making, marketing and selling biopharmaceutical
products for the treatment of bleeding disorders;
WHEREAS, NEKTAR AL has proprietary technology useful for attaching poly(ethylene) glycol-based
molecules to pharmaceutical compounds, and is engaged in the business of performing research in
relation to REAGENTS and CONJUGATES and manufacturing bulk quantities of REAGENTS used in the
manufacture of pharmaceutical products;
WHEREAS, BAXTER has developed proprietary technology concerning FACTOR VIII and [***], including
the [***] for improving the half-life of FACTOR VIII, and desires to continue such development by
entering into an exclusive research and development agreement with NEKTAR AL for the purpose of
determining whether NEKTAR ALs proprietary technology can improve the same, and NEKTAR AL desires
to exclusively partner with BAXTER to perform such continued development for extending the
half-life of FACTOR VIII using its proprietary technology directly with FACTOR VIII or [***];
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
1
WHEREAS, BAXTER desires to provide NEKTAR AL with recombinant FACTOR VIII and [***] to use in
developing SELECTED REAGENTS and CONJUGATES, and NEKTAR AL desires to, as provided for in this
AGREEMENT, provide BAXTER with CONJUGATES and SELECTED REAGENTS for BAXTERs evaluation and
potential pre-clinical, clinical and/or commercial development;
WHEREAS, BAXTER shall bear all costs associated with the research and development of NEKTAR ALs
CONJUGATES and REAGENTS into POTENTIAL PRODUCTS and COMMERCIAL PRODUCTS, and shall have ultimate
control over all product development decisions;
WHEREAS, NEKTAR AL desires to manufacture and supply BAXTER with all of its SELECTED REAGENT
requirements (including pre-clinical, clinical trial, POTENTIAL PRODUCT and COMMERCIAL PRODUCT
requirements) and BAXTER desires to satisfy all of its SELECTED REAGENT requirements from NEKTAR
AL; and
WHEREAS, BAXTER shall have an exclusive license to any POTENTIAL PRODUCTS or COMMERCIAL PRODUCTS
developed in the course of this AGREEMENT.
NOW, THEREFORE, in consideration of the foregoing and the covenants and promises contained in this
AGREEMENT and in accordance with and subject to the terms and conditions specified below, the
PARTIES agree as follows:
AGREEMENT 1.
Definitions
|
1.1 |
|
AFFILIATE means, with respect to any person or entity, any other person or
entity that directly or indirectly controls, is controlled by, or is under common
control with, such person or entity. For purposes of this definition only, control,
controlled by and under common control with shall mean the possession of the power
to direct or
cause the direction of the management and policies of an entity, whether through
the ownership of voting stock or partnership interest, by contract or otherwise. In
the case of a corporation, the direct or indirect ownership of fifty percent (50%)
or more of its outstanding voting shares or the ability otherwise to elect a
majority of the board of directors or other managing authority of the entity shall
in any event be deemed to confer control, it being understood that the direct or
indirect ownership of a lesser percentage of such shares shall not necessarily
preclude the existence of control. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
2
|
1.2 |
|
BAXTER CORE TECHNOLOGY means: |
|
(i) |
|
[***]; |
|
|
(ii) |
|
a composition of a [***] as disclosed in any of the examples of
the [***] on the EFFECTIVE DATE, or [***] shall not fall within the BAXTER CORE
TECHNOLOGY and shall instead be considered JOINTLY OWNED TECHNOLOGY; |
|
|
(iii) |
|
a method of: (a) [***]; provided that in each case none of
such methods employs a NEKTAR PROPRIETARY METHOD on the EFFECTIVE DATE. |
|
|
(iv) |
|
methods of [***]; |
|
|
(v) |
|
methods of [***]; |
|
|
(vi) |
|
methods of [***]; |
|
|
(vii) |
|
[***]; |
|
|
(viii) |
|
methods of [***]; |
|
|
(ix) |
|
the methods [***]; |
|
|
(x) |
|
[***]. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
3
|
1.3 |
|
BAXTER CORE TECHNOLOGY INVENTIONS has the meaning set forth in Section 16.5. |
|
|
1.4 |
|
BAXTER INDEMNITEE has the meaning set forth in Section 15.1.1. |
|
1.5 |
|
BAXTER KNOW-HOW means all KNOW-HOW [***]. For the avoidance of doubt, [***]
are excluded from the definition of BAXTER KNOW-HOW. |
|
|
1.6 |
|
BAXTER MATERIALS has the meaning set forth in Section 2.4.2. |
|
1.7 |
|
BAXTER PATENT RIGHTS means all claims in those PATENTS and PATENT
APPLICATIONS (i) [***] and (ii) that [***]. |
|
1.8 |
|
BAXTER PROPRIETARY CONJUGATE means a CONJUGATE, the composition of matter,
manufacture, use, offer for sale, sale or import of which is covered by a claim of the
[***]. |
|
1.9 |
|
[***] means BAXTERs provisional patent applications [***] (the
PROVISIONALS), and any U.S. or other patent applications claiming priority therefrom,
including any continuation, divisional, reissue, reexamination or substitution (and in
each case any foreign counterpart thereto), and any extension, renewal or supplemental
protection certificate; provided that the only additional information that may be added
after the EFFECTIVE DATE to the disclosure of the PROVISIONALS (ADDITIONAL
INFORMATION) in the preparation of a U.S. or other patent application claiming
priority from the PROVISIONALS shall be [***]. For avoidance of doubt, BAXTER agrees
that (a) [***]. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
4
|
1.10 |
|
BLA means a Biologics License Application filed with the FDA pursuant to 21
C.F.R. § 601.2 et seq., or any foreign equivalent filed with the regulatory
authorities in a country or territory to obtain MARKETING AUTHORIZATION for a
COMMERCIAL PRODUCT in such country or territory. |
|
|
1.11 |
|
CLAIMS has the meaning set forth in Section 15.1.1. |
|
|
1.12 |
|
COMMERCIAL DILIGENCE THRESHOLD has the meaning set forth in Section 9.4. |
|
1.13 |
|
COMMERCIAL PRODUCT means any POTENTIAL PRODUCT that has received MARKETING
AUTHORIZATION which BAXTER, its AFFILIATES and/or SUBLICENSEES market and/or sell for
administration to or use by humans or animals. |
|
|
1.14 |
|
CONFIDENTIAL INFORMATION has the meaning set forth in Section 11.2. |
|
1.15 |
|
CONJUGATE(S) means any chemical entity obtained by the PEGYLATION of a
REAGENT to a therapeutic agent (including a THERAPEUTIC AGENT). |
|
1.16 |
|
CONTRACT MANUFACTURER means a THIRD PARTY who (a) manufactures POTENTIAL
PRODUCT or COMMERCIAL PRODUCT on behalf of BAXTER as permitted herein, or (b)
manufactures SELECTED REAGENT as permitted under and pursuant to Schedule V. |
|
1.17 |
|
CONTROL(LED) means the ability to grant a license or sublicense as provided
for herein without violating the terms of any agreement or other arrangement with any
THIRD PARTY and, with respect to KNOW-HOW, also means that which is not known to the
other PARTY prior to disclosure thereto (whether under this AGREEMENT or the
NON-DISCLOSURE AGREEMENT), nor freely available from the public domain or THIRD
PARTIES. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
5
|
1.18 |
|
DEVELOPMENT AND PRODUCTION COMMITTEE means the committee described in Section
3.3. |
|
1.19 |
|
DISCLOSING PARTY means the PARTY disclosing CONFIDENTIAL INFORMATION to the
other PARTY hereunder. |
|
1.20 |
|
DOLLAR(S) means United States dollars. |
|
1.21 |
|
EMEA means the European Medicines Evaluation Agency, and any successor agency
thereto having the administrative authority to regulate the marketing of human
pharmaceutical products, biological therapeutic products and delivery systems in the
European Union. |
|
1.22 |
|
ESTIMATED COST has the meaning set forth in Schedule VI. |
|
1.23 |
|
[***] means a compound that is a [***]. For clarity, [***]. |
|
1.24 |
|
FACTOR VIII means a compound that is a Factor VIII molecule [***]. For
clarity, [***]. |
|
1.25 |
|
FDA means the United States Food and Drug Administration or any successor
entity that may be established hereafter which has substantially the same authority or
responsibility currently vested in the United States Food and Drug Administration. |
|
1.26 |
|
FIELD means [***], either for use alone for the treatment of [***], in the
treatment of Hemophilia A, or PEGYLATED FACTOR VIII or [***] for the treatment of
Hemophilia A. |
|
1.27 |
|
FIRST COMMERCIAL SALE means, with respect to a COMMERCIAL PRODUCT, the first
sale by BAXTER or its AFFILIATES or SUBLICENSEES to a THIRD PARTY following receipt of
MARKETING AUTHORIZATION for such
COMMERCIAL PRODUCT in the country of sale. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
6
|
1.28 |
|
FTE means the equivalent of an employee working [***] labor hours per year. |
|
1.29 |
|
FTE RATE has the meaning set forth in Section 2.2. 1.30 GAAP has the
meaning set forth in Schedule VI. |
|
1.31 |
|
INITIAL ROYALTY TERM has the meaning set forth in Section 9.2. |
|
1.32 |
|
INVENTIONS means any and all ideas, concepts, methods, procedures, processes,
improvements, inventions and discoveries, whether or not patentable, that are conceived
or first reduced to practice during and in the course of the performance of activities
conducted in connection with this AGREEMENT, including the development or manufacture
of a POTENTIAL PRODUCT or a COMMERCIAL PRODUCT. |
|
|
1.33 |
|
JOINT INVENTION has the meaning set forth in Section 16.3. |
|
1.34 |
|
JOINT PATENT APPLICATIONS and JOINT PATENT have the meanings set forth in
Section 16.7. |
|
|
1.35 |
|
JOINT STEERING COMMITTEE means the committee described in Section 3.1. |
|
1.36 |
|
JOINTLY OWNED TECHNOLOGY means an INVENTION covering the composition of
[***]. |
|
1.37 |
|
KNOW-HOW means all technical, scientific and other know-how, data, materials,
information, trade secrets, ideas, formulae, inventions, discoveries, processes,
machines, compositions of matter, improvements, protocols, techniques, works of
authorship, and results of experimentation and testing (whether or not patentable) in
written, electronic, oral or any other form that is not known to the other PARTY prior
to disclosure thereto (whether under this AGREEMENT or the NON-DISCLOSURE
AGREEMENT), nor freely available from the public domain or from THIRD PARTIES. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
7
|
1.38 |
|
LAW(S) means any local, state or federal rule, regulation, statute or law in
any jurisdiction relevant to the activities undertaken pursuant to this AGREEMENT or
applicable to either of the PARTIES with respect to any matters set forth herein. |
|
1.39 |
|
MAJOR MARKETS has the meaning set forth in Section 9.2.1. |
|
|
1.40 |
|
MANUFACTURING COST has the meaning set forth in Schedule VI. |
|
1.41 |
|
MARKETING AUTHORIZATION means the requisite governmental approval for the
marketing and sale of a COMMERCIAL PRODUCT in a given country. |
|
|
1.42 |
|
MILESTONE means the milestone payments set forth in Schedule II. |
|
|
1.43 |
|
NEKTAR AL CORE TECHNOLOGY means: |
|
(i) |
|
[***]; |
|
|
(ii) |
|
methods of [***]; |
|
|
(iii) |
|
methods of [***]; |
|
|
(iv) |
|
methods of [***]; |
|
|
(v) |
|
methods of [***]; |
|
|
(vi) |
|
[***]; |
|
|
(vii) |
|
methods of [***]. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
8
|
1.44 |
|
NEKTAR AL CORE TECHNOLOGY INVENTIONS has the meaning set forth in
Section 16.4. |
|
|
1.45 |
|
NEKTAR AL INDEMNITEE has the meaning set forth in Section 15.1.2. |
|
|
1.46 |
|
NEKTAR AL KNOW-HOW means all KNOW-HOW [***]. |
|
1.47 |
|
NEKTAR AL LICENSED TECHNOLOGY means, collectively, the NEKTAR AL PATENT
RIGHTS and NEKTAR AL KNOW-HOW. |
|
|
1.48 |
|
NEKTAR AL MATERIALS has the meaning set forth in Section 2.4.1. |
|
1.49 |
|
NEKTAR AL PATENT RIGHTS means all of the claims in those PATENTS and PATENT
APPLICATIONS CONTROLLED by NEKTAR AL which (i) pertain to [***]. |
|
|
1.50 |
|
NEKTAR PROPRIETARY METHODS means (i) [***]. |
|
1.51 |
|
NEKTAR PROPRIETARY REAGENT means a REAGENT, the composition of matter,
manufacture, use, offer for sale, sale or import of which is covered by [***]. |
|
1.52 |
|
NET SALES means the amount invoiced by BAXTER, its AFFILIATES or SUBLICENSEES
for the sale to THIRD PARTIES of COMMERCIAL PRODUCT commencing with the FIRST
COMMERCIAL SALE. [***]: |
|
(i) |
|
[***]; |
|
|
(ii) |
|
[***]; |
|
|
(iii) |
|
[***]; |
|
|
(iv) |
|
[***]; |
|
|
(v) |
|
[***]. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
9
In addition to the foregoing [***], BAXTER may [***] of the aggregate gross amount
invoiced on account of sales of a COMMERCIAL PRODUCT by BAXTER, its AFFILIATES or
SUBLICENSEES to THIRD PARTIES in the relevant country during the relevant calendar
quarter in respect of which royalties are being calculated or (b) [***] during the
relevant calendar quarter in respect of which royalties are being calculated.
[***]. In addition, BAXTERS NET SALES hereunder are subject to the following:
|
(A) |
|
[***]; |
|
|
(B) |
|
[***]; |
|
|
(C) |
|
[***]. |
|
1.53 |
|
NONCONFORMING REAGENTS has the meaning set forth in Section 6.3. |
|
|
1.54 |
|
NON-DISCLOSURE AGREEMENT means that agreement entered into between the
PARTIES on [***], providing for confidential treatment of the PARTIES information. |
|
1.55 |
|
PATENT means any claim in a patent including any extension, substitution,
registration, confirmation, reissue, supplemental protection certificate,
re-examination or renewal of such patent, to the extent valid and enforceable rights
are granted by a governmental authority thereunder (and in each case any foreign
counterpart thereto). |
|
1.56 |
|
PATENT APPLICATION means any claim in an application for letters patent,
including a provisional application, converted provisional application, continuation
application, a continued prosecution application, a continuation-in-part application, a
divisional application, a re-examination application, and a reissue application (and
in each case any foreign counterpart thereto). |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
10
|
1.57 |
|
PEG means poly(ethylene) glycol. |
|
1.58 |
|
PEGYLATION, with correlative meanings PEGYLATED or to PEGYLATE, means
covalent chemical bonding of any REAGENT (including a SELECTED REAGENT and including
covalent chemical bonding through linking groups), with or to another material or
materials. Such materials include, without limitation, proteins, peptides, polymers,
oligomers, oligonucleotides, other biomolecules, small molecules, therapeutic agents
(including a THERAPEUTIC AGENT), diagnostic agents, imaging agents and detectable
labels. Additional materials that may be PEGYLATED include, without limitation,
polymers, liposomes, films, chemical separation and purification surfaces, solid
supports, metal/metal oxide surfaces and other surfaces such as, by way of example but
not limitation, those on implanted devices, and equipment, where a REAGENT is
covalently chemically bonded to one or more reactive molecules on the surface of such
device or equipment. PEGYLATION shall include the synthesis, derivatization,
characterization, and modification of PEG for such purposes, together with the
synthesis, derivatization, characterization, and modification of the raw materials and
intermediates for the manufacture of REAGENTS (including SELECTED REAGENTS) or products
(including POTENTIAL PRODUCTS and COMMERCIAL PRODUCTS) incorporating such REAGENT by
means of covalent chemical bonding, and all methods of making and using each and all of
the foregoing. |
|
1.59 |
|
PHASE 1 CLINICAL TRIAL means the first lawful study in humans, conducted in
accordance with 21 C.F.R. §312.21(a) (or the equivalent LAWS and regulations in
jurisdictions outside the United States). |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
11
|
1.60 |
|
PHASE 2 CLINICAL TRIAL means a controlled clinical trial, conducted in
accordance with 21 C.F.R. §312.21(b) (or the equivalent LAWS and regulations in
jurisdictions outside the United States). |
|
1.61 |
|
PIVOTAL TRIAL, also known as a Phase 3 clinical trial, means a controlled or
uncontrolled clinical trial, conducted in accordance with § 21 C.F.R. 312.21(c) (or the
equivalent LAWS and regulations in jurisdictions outside the United States). |
|
1.62 |
|
POTENTIAL PRODUCT means (i) any chemical entity resulting from attachment of
any THERAPEUTIC AGENT to a SELECTED REAGENT by means of PEGYLATION that is selected by
the RESEARCH COMMITTEE or (ii) any product using PEGYLATION to extend or otherwise
improve the half-life of [***] FACTOR VIII, whether by using PEGYLATION technology
directly with [***] FACTOR VIII, or by means of the PEGYLATION of [***]. |
|
1.63 |
|
PURCHASE PRICE has the meaning set forth in Section 8.6.1 |
|
|
1.64 |
|
QUALITY AGREEMENT(S) shall include: |
|
(i) |
|
the quality agreement governing the manufacture and supply of
[***], which shall be negotiated by the PARTIES [***]; and |
|
(ii) |
|
the quality agreement governing the manufacture and supply of
[***], which shall be negotiated by the PARTIES [***]. |
The QUALITY AGREEMENT(S) shall be in substantially the same form as Schedule III
hereto. For purposes hereof, [***].
|
1.65 |
|
REAGENT means a PEG derivative used in the manufacture of a pharmaceutical
or diagnostic product or medical device, including a SELECTED REAGENT. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
12
|
1.66 |
|
RECIPIENT means the PARTY receiving CONFIDENTIAL INFORMATION hereunder. |
|
|
1.67 |
|
RESEARCH COMMITTEE means the committee described in Section 3.2. |
|
1.68 |
|
RESEARCH PLAN means the PARTIES respective activities and responsibilities
as set forth in the RESEARCH PLAN attached hereto as Schedule I, as amended and
revised by the RESEARCH COMMITTEE from time to time. |
|
1.69 |
|
RESPONSIBLE PARTY has the meaning set forth in Section 16.7.
|
|
1.70 |
|
ROYALTY RATE means the following: |
|
(i) |
|
[***] NET SALES of all COMMERCIAL PRODUCTS sold in a calendar
year; |
|
(ii) |
|
[***] NET SALES of all COMMERCIAL PRODUCTS sold in such
calendar year; and |
|
(iii) |
|
[***] NET SALES of all COMMERCIAL PRODUCTS sold in such
calendar year [***]. |
By way of example but not limitation, if NET SALES of all COMMERCIAL PRODUCTS sold
in a calendar year are [***] then BAXTER shall pay to NEKTAR AL a royalty of [***]
on the [***] of such NET SALES, [***] on the portion of such NET SALES between
[***] and [***] and [***] on the portion of such NET SALES [***]. For clarity, the
ROYALTY RATE shall be applied to the aggregate annual worldwide NET SALES of all
COMMERCIAL PRODUCTS, and [***]. By way of example but not limitation, if during any
one calendar year, there are two (2) COMMERCIAL PRODUCTS being sold by or on behalf
of BAXTER or its AFFILIATES or SUBLICENSEES, and NET SALES of one COMMERCIAL
PRODUCT sold in such calendar year are [***], and NET SALES of the other
COMMERCIAL PRODUCT sold in the same calendar year are [***] then, for the purposes
hereof, the aggregate annual NET SALES of all COMMERCIAL PRODUCTS will be deemed to
be [***] for such calendar year, and BAXTER shall pay to NEKTAR AL a royalty of
[***] on the [***] of such NET SALES, [***] on the portion of such NET SALES
between [***] and [***], and [***] on the portion of such NET SALES in excess of
[***], for total payments by BAXTER of [***].
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
13
|
1.71 |
|
SCIENTIFIC ADVISORS has the meaning set forth in Section 3.1. |
|
1.72 |
|
SCIENTIFIC AND TECHNICAL ADVISORY BOARD means the board described in Section
3.1. |
|
1.73 |
|
SELECTED REAGENT means a REAGENT that is attached to a THERAPEUTIC AGENT by
means of PEGYLATION in a POTENTIAL PRODUCT or COMMERCIAL PRODUCT, as selected by the
RESEARCH COMMITTEE. |
|
|
1.74 |
|
SOLE INVENTION has the meaning set forth in Section 16.3. |
|
1.75 |
|
SPECIFICATIONS means the specifications for a SELECTED REAGENT to be used in
a POTENTIAL PRODUCT or COMMERCIAL PRODUCT determined based upon definitive testing
criteria that are agreed in writing by the DEVELOPMENT AND PRODUCTION COMMITTEE and
which will be set forth in the applicable QUALITY AGREEMENT. |
|
1.76 |
|
SUBLICENSEE means any person or entity, including AFFILIATES, to which BAXTER
grants a sublicense (i) to research and/or develop POTENTIAL PRODUCTS or COMMERCIAL
PRODUCTS or (ii) to make, have made, use, sell, have sold, offer for sale and/or import
POTENTIAL PRODUCTS or COMMERCIAL PRODUCTS (which for the purposes hereof will include
the right to
distribute, market or promote). |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
14
|
1.77 |
|
SUPPLY AGREEMENT means the supply agreement to be entered into by the PARTIES
in accordance with Section 5.3. |
|
|
1.78 |
|
TERM has the meaning set forth in Section 19.1. |
|
|
1.79 |
|
TERRITORY means the world. |
|
1.80 |
|
THERAPEUTIC AGENT means [***] FACTOR VIII [***] of each of the foregoing. For
clarity, THERAPEUTIC AGENT does not include [***]. |
|
1.81 |
|
THIRD PARTY means any entity other than NEKTAR AL, BAXTER, a SUBLICENSEE of
BAXTER or their respective AFFILIATES, whether such THIRD PARTY is a person, company,
corporation, limited liability company, partnership or other such legal entity, or a
division or operating or business unit of such legal entity. |
|
1.82 |
|
VALID PATENT CLAIM means a claim of an issued and unexpired PATENT within the
[***] covering the manufacture, use, sale, offer for sale or import of a SELECTED
REAGENT or a COMMERCIAL PRODUCT, which PATENT is owned or CONTROLLED by NEKTAR AL or
jointly by the PARTIES and has not (a) expired or been canceled, (b) been declared
invalid by an unreversed and unappealable decision of a court or other appropriate body
of competent jurisdiction, (c) been admitted to be invalid or unenforceable through
reissue, disclaimer, or otherwise or (d) been abandoned. |
|
1.83 |
|
[***] means the [***]. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
15
2. |
|
RESEARCH AND DEVELOPMENT ACTIVITIES |
|
2.1 |
|
OVERVIEW. The PARTIES research and development responsibilities are
set forth in the RESEARCH PLAN, which shall be an evolving document that is updated and
revised from time to time in writing by the RESEARCH COMMITTEE. |
As decided by the RESEARCH COMMITTEE provided for in Section 3.2, and provided that
BAXTER provides NEKTAR AL with [***] in a timely manner in accordance with the time
frames set forth in the RESEARCH PLAN as provided for herein, NEKTAR AL shall, in a
timely manner in accordance with the time frames set forth in the RESEARCH PLAN,
provide BAXTER with [***] in its research and development activities to extend the
half-life of FACTOR VIII using PEGYLATION directly with FACTOR VIII [***]. BAXTER
shall, in a timely manner in accordance with the time frames set forth in the
RESEARCH PLAN, provide NEKTAR AL with [***] to use in developing REAGENTS and
CONJUGATES.
NEKTAR AL shall use commercially reasonable efforts to collaborate and cooperate
with BAXTER in researching and developing CONJUGATES and REAGENTS (including
SELECTED REAGENTS) to be utilized in developing POTENTIAL PRODUCTS pursuant to the
RESEARCH PLAN, as amended from time to time. [***] After the RESEARCH COMMITTEE
selects one or more CONJUGATES to develop into POTENTIAL PRODUCTS, the REAGENT that
is used to make each such CONJUGATE shall be deemed a SELECTED REAGENT hereunder,
and [***].
[***], in accordance with the RESEARCH PLAN, and for all costs and expenses
associated therewith (subject to the approval requirements set forth herein).
For clarity, [***]. During such clinical trials, or in the event of the
cancellation or failure of any such clinical trials, [***], in accordance with
Section 3.2.
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
16
|
2.2 |
|
NEKTAR AL PAYMENTS. In addition to the MILESTONES and royalties to be
paid by BAXTER to NEKTAR AL hereunder, BAXTER shall pay NEKTAR AL for all [***]
directly incurred and solely associated with the development and manufacture of such
CONJUGATES and REAGENTS (including SELECTED REAGENTS). NEKTAR ALs [***], subject to
the following increases: NEKTAR AL shall adjust the [***] for each calendar year
commencing with the year 2006 to reflect any year-to-year increase in the Consumer
Price Index (CPI) (based on a cumulative index of CPI numbers starting on the EFFECTIVE
DATE to the date of the calculation of such [***]). |
[***], which materials shall be equipment purchased by NEKTAR AL that is required
for the performance of its activities under the RESEARCH PLAN. The cost of such
additional materials shall not exceed [***]. BAXTER shall respond to such a request
by NEKTAR AL promptly, and in no event later than thirty (30) days after its receipt
of such request.
NEKTAR AL shall not bill BAXTER, and BAXTER shall not be required to pay NEKTAR AL,
for the first [***] expended by NEKTAR AL in performing activities under the
RESEARCH PLAN.
NEKTAR AL shall invoice such [***] to BAXTER on a [***], pursuant to Section 10.2.
For clarity, BAXTER shall pay for [***], which shall be calculated by multiplying
(i) [***] pursuant to this AGREEMENT by (ii) the quotient of (a) the [***] divided
by (b) [***]. BAXTER shall pay the amounts set forth in each such invoice within
[***] after the date thereof.
For clarity, BAXTER shall pay NEKTAR AL as provided for under this Section 2.2 for
so long as NEKTAR AL is performing activities under the RESEARCH PLAN; provided,
however, that on a POTENTIAL PRODUCT-by-POTENTIAL PRODUCT
basis, [***] and, thereafter, the costs and expenses to be paid by [***].
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
17
|
2.3 |
|
MARKETING AUTHORIZATION. As between the PARTIES, BAXTER shall be
responsible for all development activities under the RESEARCH PLAN, all manufacturing
activities associated with the manufacture of POTENTIAL PRODUCTS and COMMERCIAL
PRODUCTS, all activities associated with the [***], and for the [***] for COMMERCIAL
PRODUCTS. [***]. |
|
2.4.1 |
|
NEKTAR AL MATERIALS. Any samples of SELECTED REAGENTS
or CONJUGATES that are provided by NEKTAR AL to BAXTER in the course of the
RESEARCH PLAN (collectively, the NEKTAR AL MATERIALS) are owned exclusively
by NEKTAR AL and provided solely for the performance of the RESEARCH PLAN, or
to otherwise extend the half-life of a THERAPEUTIC AGENT, and for no other
purpose. Without limitation, BAXTER will not: |
|
(i) |
|
[***]; |
|
|
(ii) |
|
[***]; |
|
|
(iii) |
|
[***]; |
|
|
(iv) |
|
[***]; |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
18
except in each case, to extend the half-life of a THERAPEUTIC AGENT or otherwise in
conjunction with the RESEARCH PLAN. For clarity, BAXTER understands and agrees that
any activities (and the results thereof) that are carried out
by or on behalf of BAXTER outside of the RESEARCH PLAN, which utilize any NEKTAR AL
MATERIALS or CONFIDENTIAL INFORMATION of NEKTAR AL (including those activities to
extend the half-life of a THERAPEUTIC AGENT utilizing any NEKTAR AL MATERIALS or
any CONFIDENTIAL INFORMATION OF NEKTAR AL), are subject to and governed by the
terms and conditions of this AGREEMENT. For avoidance of doubt, [***].
|
2.4.2 |
|
BAXTER MATERIALS. Any samples of [***] FACTOR VIII
[***] provided by BAXTER to NEKTAR AL (collectively, the BAXTER MATERIALS)
are owned exclusively by BAXTER and provided solely for the development of
CONJUGATES and REAGENTS to extend the half-life of a THERAPEUTIC AGENT in
conjunction with the RESEARCH PLAN, and for no other purpose. Without
limitation, NEKTAR AL will not: |
|
(i) |
|
[***]; |
|
|
(ii) |
|
[***]; |
|
|
(iii) |
|
[***]; |
|
|
(iv) |
|
[***]; or |
except in each case, to extend the half-life of a THERAPEUTIC AGENT in conjunction
with the RESEARCH PLAN.
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
19
|
2.5 |
|
HANDLING. The PARTIES understand and agree the BAXTER MATERIALS and
NEKTAR AL MATERIALS may have unpredictable and unknown biological and/or chemical
properties and that they are to be handled and used with caution. The
PARTIES will handle and use such materials and conduct their respective activities
under the RESEARCH PLAN in compliance with all applicable LAWS. Each PARTY will
maintain reasonable security measures, no less strict than it maintains to protect
its own valuable tangible property, to protect the other PARTYS materials against
loss, theft or destruction. Other than in connection with the performance of its
obligations under this AGREEMENT, neither PARTY will sell, lease, license, copy,
transfer, disclose or otherwise provide access to the other PARTYs materials to
any person, entity or location without the prior written consent of the other
PARTY, such consent not to be unreasonably withheld or delayed. This provision
shall not prevent BAXTER from sublicensing (to the extent provided for in Article
4) or outsourcing some or all if its research or development activities. In such
case, BAXTER shall require any SUBLICENSEE or THIRD PARTY performing such
obligations to be bound by similar security, handling, confidentiality and
assignment of INVENTIONS obligations as are set forth in this AGREEMENT, including
without limitation, under Sections 2.4.1, 2.5 and 4.4 and Articles 11 and 16. |
|
2.6 |
|
SELECTION OF POTENTIAL PRODUCTS AND [***]. The RESEARCH COMMITTEE shall
select POTENTIAL PRODUCT(S) from the CONJUGATES and SELECTED REAGENTS provided by
NEKTAR AL and, following such selection, [***]. |
|
2.7 |
|
DISCLAIMER OF WARRANTY WITH RESPECT TO BAXTER MATERIALS. BAXTER HEREBY
ACKNOWLEDGES THE EXPERIMENTAL NATURE OF THE RESEARCH AND THAT NEKTAR AL CANNOT
GUARANTEE OR PROVIDE ANY WARRANTIES REGARDING THE QUANTITY OF BAXTER MATERIALS
REQUIRED TO CONDUCT THE RESEARCH OR TO BE CONSUMED IN THE PERFORMANCE OF THE RESEARCH.
EXCEPT IN THE CASE OF NEKTAR ALS NEGLIGENCE OR WILLFUL MISCONDUCT,
NEKTAR AL SHALL NOT BE LIABLE FOR ANY DAMAGES OR LOSSES SUFFERED BY BAXTER ARISING
FROM THE USE, CONSUMPTION OR LOSS OF BAXTER MATERIALS IN THE PERFORMANCE OF THE
RESEARCH PURSUANT TO THIS AGREEMENT. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
20
|
3.1 |
|
JOINT STEERING COMMITTEE. To facilitate communication between the
PARTIES, implement the RESEARCH PLAN and oversee development of POTENTIAL PRODUCTS and
COMMERCIAL PRODUCTS (all during the TERM), the PARTIES shall appoint a JOINT STEERING
COMMITTEE consisting of [***] representatives from each of NEKTAR AL and BAXTER. The
initial representatives are: |
|
|
|
BAXTER: [***] |
|
|
|
|
NEKTAR AL: [***] |
and the initial meeting of the JOINT STEERING COMMITTEE shall take place no later
than [***] after the EFFECTIVE DATE. Each PARTY may replace its representatives on
the JOINT STEERING COMMITTEE by prior written notice to the other PARTY. The JOINT
STEERING COMMITTEE shall supervise the activities of the RESEARCH COMMITTEE and the
DEVELOPMENT AND PRODUCTION COMMITTEE; resolve issues referred by members of the
RESEARCH COMMITTEE and the DEVELOPMENT AND PRODUCTION COMMITTEE; make strategic
decisions related to research and development activities in connection with
POTENTIAL PRODUCTS and COMMERCIAL PRODUCTS; review the progress of research and
development activities in connection with POTENTIAL PRODUCTS and COMMERCIAL
PRODUCTS with
respect to BAXTERs progress in pre-clinical studies, clinical trials, and meeting
the Development Diligence Timeline set forth in Schedule IV; and review progress in
seeking MARKETING AUTHORIZATIONS. The JOINT STEERING COMMITTEE shall also be
responsible for sharing certain data and information relating to the PARTIES
respective research and development, manufacturing and commercialization activities
in connection with the POTENTIAL PRODUCTS and COMMERCIAL PRODUCTS, which data and
information shall include, without limitation, the following: (i) any delays in
meeting the Development Diligence milestone dates set forth in Schedule IV; (ii)
any failure in any pre-clinical or clinical trials; (iii) any termination of active
development of any POTENTIAL PRODUCT or SELECTED REAGENT; (iv) commencing any
clinical trial and completing any clinical trial; and (v) summary data
demonstrating whether the milestone success criteria set forth in Schedule II
(including endpoints) have been met. [***].
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
21
The JOINT STEERING COMMITTEE shall meet at such times and places, in person or by
telephone conferencing, web-conferencing, video conferencing or other electronic
communication, as it shall determine to carry out its responsibilities. The JOINT
STEERING COMMITTEE shall operate [***]. If a dispute arises regarding matters within
the scope of responsibilities of the JOINT STEERING COMMITTEE (other than disputes
referred to the JOINT STEERING COMMITTEE by the RESEARCH COMMITTEE for resolution in
accordance with Section 3.2), and the JOINT STEERING COMMITTEE fails to reach a
consensus on its resolution [***], then the dispute shall be referred to the senior
management representatives of each PARTY. For purposes of the JOINT STEERING
COMMITTEE, BAXTERS senior management representative shall be its [***].
The PARTIES to the JOINT STEERING COMMITTEE shall create a SCIENTIFIC AND TECHNICAL
ADVISORY BOARD for the purpose of reviewing results and
decisions occurring from the development of a POTENTIAL PRODUCT. The SCIENTIFIC AND
TECHNICAL ADVISORY BOARD shall consist of [***]. The SCIENTIFIC AND TECHNICAL
ADVISORY BOARD should bring their expertise to support matters referred to it by
the RESEARCH COMMITTEE or the DEVELOPMENT AND PRODUCTION COMMITTEE. Any
representative on the RESEARCH COMMITTEE or the DEVELOPMENT AND PRODUCTION
COMMITTEE may refer matters to the SCIENTIFIC AND TECHNICAL ADVISORY BOARD for its
input and advice. The input and advice of the SCIENTIFIC AND TECHNICAL ADVISORY
BOARD shall be for informational purposes only and shall not be binding on the
PARTIES.
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
22
|
3.2 |
|
RESEARCH COMMITTEE. The RESEARCH COMMITTEE shall be comprised of
appropriate representatives of both PARTIES, initially consisting of [***]
representatives from each of NEKTAR AL and BAXTER. Each PARTY shall appoint a RESEARCH
PLAN team leader (and other key contacts, as necessary) to serve as principal RESEARCH
COMMITTEE liaisons for the PARTIES. Employees of each PARTY who are not on the
RESEARCH COMMITTEE may attend meetings of the RESEARCH COMMITTEE, as required to
further the research and development of POTENTIAL PRODUCTS and COMMERCIAL PRODUCTS.
The initial team leader and PARTY representatives are: |
BAXTER: (1) [***]
NEKTAR AL: (1) [***]
Any representative of the RESEARCH COMMITTEE may designate another individual from
such representatives PARTY to attend a meeting of the RESEARCH COMMITTEE in his or
her place. In such case, the representative shall notify the other PARTYs
representative in writing prior to the applicable meeting.
The RESEARCH COMMITTEE shall plan and manage the research and development
activities to be conducted in connection with CONJUGATES, POTENTIAL PRODUCTS and
COMMERCIAL PRODUCTS and to facilitate communication on research and development
issues between the PARTIES. The RESEARCH COMMITTEE shall also be responsible for
the sharing of certain data relating to the PARTIES respective research and
development activities in connection with the RESEARCH PLAN and data related to
CONJUGATES and POTENTIAL PRODUCTS, including the results [***].
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
23
Modification to, and implementation of, the RESEARCH PLAN and other day-to-day
research and development activities shall be managed by the RESEARCH COMMITTEE,
subject to oversight by the JOINT STEERING COMMITTEE. The RESEARCH COMMITTEE shall
meet no less frequently than [***] in person, by teleconference, web-conference or
video conference as agreed upon by the PARTIES.
Notwithstanding anything herein to the contrary, the RESEARCH COMMITTEE shall
operate by consensus with representatives of NEKTAR AL having [***] and
representatives of BAXTER having [***]. In the event of any disagreements between
the PARTIES representatives at the RESEARCH COMMITTEE level (including, without
limitation, with respect to selection of a SELECTED REAGENT), the disagreement shall
be referred to the JOINT STEERING COMMITTEE for resolution and, if the JOINT
STEERING COMMITTEE is unable to resolve the disagreement within [***] after the
matter is referred to the JOINT STEERING COMMITTEE, [***].
In order to enable NEKTAR AL to plan its [***] beyond those already contemplated by
the RESEARCH PLAN, the RESEARCH COMMITTEE shall notify NEKTAR AL in writing no less
than [***] in advance of any additional requirements for
REAGENTS (including SELECTED REAGENTS) and CONJUGATES that are to be developed under
the RESEARCH PLAN, or the conduct of studies or the performance of other related
services under the RESEARCH PLAN.
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
24
|
3.3 |
|
DEVELOPMENT AND PRODUCTION COMMITTEE. Within [***] after a POTENTIAL PRODUCT has been
selected by the RESEARCH COMMITTEE, the JOINT STEERING COMMITTEE shall appoint a DEVELOPMENT AND
PRODUCTION COMMITTEE to plan and manage the manufacturing and supply activities to be performed
under this AGREEMENT with respect to the SELECTED REAGENT for such POTENTIAL PRODUCT, and
facilitate communication between the PARTIES during such time as NEKTAR AL supplies BAXTER with
such SELECTED REAGENT hereunder. The
DEVELOPMENT AND PRODUCTION COMMITTEE shall be responsible for discussing in good faith and
agreeing on issues relating to forecasting and contingency planning. The DEVELOPMENT
AND PRODUCTION COMMITTEE shall operate by consensus with representatives of NEKTAR AL
having [***] and representatives of BAXTER having [***]. In the event of any
disagreements between the PARTIES representatives at the DEVELOPMENT AND PRODUCTION
COMMITTEE level, the disagreement shall first be referred to the JOINT STEERING
COMMITTEE for resolution. If the disagreement is not resolved by the JOINT STEERING
COMMITTEE within [***] after the matter is referred to it for resolution, then the
matter shall be referred to the senior management representatives of each PARTY for
resolution, which senior management representatives shall be for Baxter [***] and for
Nektar AL [***]. |
|
3.4 |
|
AMENDMENT; WAIVER. Notwithstanding anything to the contrary herein,
neither the JOINT STEERING COMMITTEE, the RESEARCH COMMITTEE nor the DEVELOPMENT AND
PRODUCTION COMMITTEE shall have the right or
power to amend the terms of this AGREEMENT or waive rights or obligations of the
PARTIES hereunder, or take any action that would conflict with any provision of
this AGREEMENT, the SUPPLY AGREEMENT or a QUALITY AGREEMENT. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
25
4. |
|
LICENSES TO NEKTAR AL LICENSED TECHNOLOGY AND BAXTER TECHNOLOGY |
|
4.1 |
|
LICENSE TO BAXTER. Subject to the terms and conditions of this
AGREEMENT, NEKTAR AL hereby grants to BAXTER a worldwide, exclusive, royalty-bearing
license, with the right to grant sublicenses as provided in Section 4.2, under the
NEKTAR AL LICENSED TECHNOLOGY to develop, make, have made, import, export, use, sell,
offer for sale and have sold POTENTIAL PRODUCTS and COMMERCIAL PRODUCT(S) in the
FIELD. For clarity, [***]. |
|
4.2 |
|
TERMS OF SUBLICENSE. The terms of each sublicense under the license
granted to BAXTER in Section 4.1 of this AGREEMENT shall provide that any SUBLICENSEE
shall be subject to and consistent with the terms and conditions of this AGREEMENT;
provided, however, that: |
|
(i) |
|
All royalties or other amounts due to NEKTAR AL with respect
to such SUBLICENSEES development and/or commercialization of POTENTIAL
PRODUCT or COMMERCIAL PRODUCT shall be collected by BAXTER and transmitted to
NEKTAR AL in accordance with the payment terms set forth in Article 9; |
|
(ii) |
|
BAXTERS grant of any sublicense shall not relieve BAXTER from
any of its obligations under this AGREEMENT; and |
|
(iii) |
|
BAXTER shall remain jointly and severally liable for any
breach of a
sublicense by a SUBLICENSEE. |
Notwithstanding the foregoing, [***].
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
26
|
4.3 |
|
NEKTAR AL RESEARCH RIGHTS AND LIMITATIONS. Notwithstanding anything to
the contrary in this AGREEMENT and without limiting any other retained rights, the
license granted under Section 4.1 shall be subject to the retained right of NEKTAR AL
and its AFFILIATES: |
|
(i) |
|
to practice the NEKTAR AL LICENSED TECHNOLOGY for the conduct
of research and development of products that it is developing itself; |
|
(ii) |
|
to practice the NEKTAR AL LICENSED TECHNOLOGY for any
purposes, including the research, development, manufacture and
commercialization of products, whether itself or with or for others, outside
of the FIELD; |
|
(iii) |
|
to sell REAGENTS (including SELECTED REAGENTS) through NEKTAR
ALS catalog for research purposes (subject to the limitations set forth
below); and |
|
(iv) |
|
to perform their respective obligations to THIRD PARTIES set
forth in agreements existing as of the EFFECTIVE DATE, [***]. |
NEKTAR AL covenants that during the TERM, [***]. NEKTAR AL further covenants that
during the TERM, [***].
NEKTAR AL covenants that during the TERM, [***]. BAXTER understands and agrees that
neither NEKTAR AL nor its AFFILIATES will have an obligation to [***].
For clarification, nothing in this Agreement, including any retained rights of
NEKTAR AL and its AFFILIATES, grants NEKTAR AL or its AFFILIATES any rights under
BAXTER PATENT RIGHTS, [***], other than for the purposes of performing any
obligations under this AGREEMENT, including, without limitation, NEKTAR ALs
obligations under the RESEARCH PLAN, for the research and development for BAXTER of
CONJUGATES, POTENTIAL PRODUCTS OR COMMERCIAL PRODUCTS.
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
27
|
4.4 |
|
NO IMPLIED RIGHTS OR LICENSES. Neither PARTY grants to the other any
rights or licenses, including to any BAXTER PATENT RIGHTS or BAXTER KNOW HOW, or NEKTAR
AL PATENT RIGHTS or NEKTAR AL KNOW HOW or other intellectual property rights, whether
by implication, estoppel or otherwise, except to the extent expressly provided for
under this AGREEMENT. Other than as expressly provided for herein, neither BAXTER nor
its AFFILIATES, SUBLICENSEES or its or their contractors, may [***]. |
|
4.5 |
|
LICENSE TO NEKTAR AL. BAXTER hereby grants to NEKTAR AL a
non-exclusive, non-sublicensable, non-assignable, non-transferable, worldwide,
royalty-free license, under BAXTER KNOW-HOW and BAXTER PATENT RIGHTS, and the NEKTAR AL
LICENSED TECHNOLOGY that is licensed exclusively to BAXTER hereunder, for the sole
purpose of performing NEKTAR ALs obligations under this AGREEMENT, including the
RESEARCH PLAN. This provision shall not prevent NEKTAR AL from [***]. BAXTER shall
respond within [***] of receipt of such a request by NEKTAR AL. [***]. |
|
4.6 |
|
MUTUAL COVENANT. Each PARTY covenants and agrees that it and its
AFFILIATES shall not use or practice the intellectual property rights licensed under
this AGREEMENT except as expressly permitted by this AGREEMENT. Any use or practice of
the intellectual property rights licensed under this AGREEMENT except
as expressly permitted by this AGREEMENT that results in material harm to the other
PARTY shall constitute a material breach of this AGREEMENT. Each PARTY covenants and
agrees to cease any non-permitted use and to take all actions necessary to assign to
the other PARTY any inventions made through use or practice of such PARTYS
intellectual property rights outside the scope of the license rights granted
hereunder. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
28
5. |
|
MANUFACTURE AND SUPPLY OF SELECTED REAGENTS |
|
5.1 |
|
[***]. NEKTAR AL shall manufacture and supply and BAXTER shall purchase from
NEKTAR AL, [***] of BAXTERS and BAXTERS AFFILIATES and SUBLICENSEES requirements
of SELECTED REAGENTS, for the sole purpose of developing and manufacturing POTENTIAL
PRODUCTS and COMMERCIAL PRODUCTS pursuant to the license granted hereunder. |
|
5.2 |
|
SUPPLY PRIOR TO PIVOTAL TRIAL/SUPPLY AGREEMENT. |
|
(i) |
|
FORECAST. No later than [***] after selection of a
POTENTIAL PRODUCT by the RESEARCH COMMITTEE, BAXTER shall provide NEKTAR AL
with a [***] rolling forecast of its estimated requirements of the SELECTED
REAGENT for such POTENTIAL PRODUCT for research, pre-clinical development and
clinical development. BAXTER shall update such estimated forecast within
thirty (30) days following the start of each calendar quarter. BAXTER shall
issue purchase orders to NEKTAR AL [***] prior to the start of the calendar
quarter (such time period to be negotiated by the PARTIES in good faith after
the applicable SELECTED REAGENT is selected by the RESEARCH COMMITTEE) during
which BAXTER wishes to receive supplies of SELECTED REAGENT for use in
pre-clinical and Phase 1 and Phase 2 clinical development, until such time as
the PARTIES execute the SUPPLY AGREEMENT. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
29
|
(ii) |
|
PRICE. The price of each SELECTED REAGENT shall be the
PURCHASE PRICE, as set forth in Section 8.6.1. |
|
(iii) |
|
DELIVERY AND SHIPMENT; TITLE AND RISK OF LOSS. NEKTAR
AL shall deliver all SELECTED REAGENT to BAXTER, and [***]. |
|
5.3 |
|
PIVOTAL TRIAL AND COMMERCIAL PRODUCT SUPPLY AGREEMENT. At least [***]
prior to the anticipated date of commencement of the first PIVOTAL TRIAL for a
POTENTIAL PRODUCT, the parties shall negotiate and execute a SUPPLY AGREEMENT for the
manufacture and supply of SELECTED REAGENT for such POTENTIAL PRODUCT. The SUPPLY
AGREEMENT shall be negotiated in good faith after the PARTIES have gained insight into
the attributes of the SELECTED REAGENT, including quality requirements, testing
requirements, production cycles and production costs. For purposes of this AGREEMENT,
commencement of a clinical trial shall be deemed to occur on the date on which
POTENTIAL PRODUCT is first administered to the first patient or subject in such trial. |
The SUPPLY AGREEMENT shall include the essential terms and conditions set forth in
Schedule V and such other terms and conditions that are usual and customary for
agreements of this type.
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
30
6. |
|
SPECIFICATIONS AND MANUFACTURING WARRANTY FOR SELECTED REAGENTS |
|
6.1 |
|
SPECIFICATIONS. The SPECIFICATIONS for SELECTED REAGENTS to be supplied
pursuant to Article 5 will be set forth in the applicable QUALITY
AGREEMENT. Any modifications of the SPECIFICATIONS shall require prior written
approval of BAXTER and NEKTAR AL, not to be unreasonably withheld or delayed. Prior
to entering into the SUPPLY AGREEMENT, BAXTER shall reimburse NEKTAR AL for its
reasonable costs associated with implementing any agreed upon modifications to the
SPECIFICATIONS, including without limitation any increases in MANUFACTURING COSTS.
NEKTAR AL shall be responsible for any changes to SPECIFICATIONS initiated by NEKTAR
AL to accommodate its business needs that do not directly relate to the development
or improvement of SELECTED REAGENTS. For clarity, a change in regulatory
requirements that is unique to a SELECTED REAGENT is not a NEKTAR AL business need.
For example, if NEKTAR AL requests relocating the SELECTED REAGENT manufacturing
operations from Alabama to California to accommodate the closure of its Alabama
facility, NEKTAR AL shall be responsible for all costs related to such relocation. |
|
6.2 |
|
COMPLIANCE AUDITS. BAXTER will have the right to perform
compliance/quality audits, as set forth in the QUALITY AGREEMENTS. |
|
6.3 |
|
WARRANTY. NEKTAR AL warrants that each shipment of SELECTED REAGENT
shall, upon delivery, be in compliance/conformity with: |
|
(i) |
|
All applicable SPECIFICATIONS, |
|
|
(ii) |
|
The applicable QUALITY AGREEMENT, and |
|
(iii) |
|
ICH Q7A GUIDELINES and LAWS, as they apply to critical raw
materials, in each case with respect to those SELECTED REAGENTS used in the
manufacture of (a) POTENTIAL PRODUCTS for human clinical trials and (b) for
COMMERCIAL PRODUCTS. |
SELECTED REAGENTS that do not meet the foregoing warranties shall be deemed
NONCONFORMING REAGENTS for the purposes hereof.
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
31
|
6.4 |
|
DISCLAIMER OF WARRANTY. |
|
6.4.1 |
|
EXCEPT AS PROVIDED IN SECTION 6.3, NEKTAR AL PROVIDES NO
WARRANTIES, EXPRESS OR IMPLIED, REGARDING ANY SELECTED REAGENT, POTENTIAL
PRODUCT OR COMMERCIAL PRODUCT, OR NEKTAR AL LICENSED TECHNOLOGY, AND HEREBY
DISCLAIMS ALL OTHER WARRANTIES, EXPRESS AND IMPLIED, INCLUDING WITHOUT
LIMITATION THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE AND NON-INFRINGEMENT. BAXTER ACKNOWLEDGES THAT NEKTAR AL CANNOT
GUARANTEE THE SAFETY, NON-TOXICITY, FITNESS OR EFFICACY OF SELECTED REAGENTS,
POTENTIAL PRODUCTS OR COMMERCIAL PRODUCTS, AND BAXTER ACCEPTS ANY AND ALL RISK
RESULTING FROM ITS USE OF CONJUGATES, REAGENTS, SELECTED REAGENTS, POTENTIAL
PRODUCTS OR COMMERCIAL PRODUCTS. |
|
6.4.2 |
|
EXCEPT AS PROVIDED IN SECTION 6.3, NEITHER PARTY PROVIDES ANY
WARRANTIES, EXPRESS OR IMPLIED, REGARDING THE RESEARCH PLAN OR ANY REAGENT,
CONJUGATE, PRODUCT (INCLUDING THE SUCCESSFUL DEVELOPMENT, REGISTRATION,
MANUFACTURE OR COMMERCIALIZATION OF ANY POTENTIAL PRODUCT) OR DELIVERABLE
PROVIDED PURSUANT TO THE RESEARCH PLAN, AND EACH PARTY DISCLAIMS ALL EXPRESS
AND IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION
THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE
AND NON-INFRINGEMENT. FOR CLARITY, THE FOREGOING SHALL NOT DIMINISH NEKTAR
ALS OBLIGATIONS PURSUANT TO SECTION 15.1.1. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
32
|
7.1 |
|
NEKTAR AL. In consideration of the MILESTONES, royalties and other
consideration set forth herein, NEKTAR AL agrees to partner exclusively with BAXTER in
the FIELD. Specifically, during the TERM, other than as provided for in this AGREEMENT
or under the RESEARCH PLAN, [***]. |
Nothing set forth in this Section 7.1 shall prohibit NEKTAR AL from owning not in
excess of 5% in the aggregate of any class of capital stock of any corporation if
such stock is publicly traded and listed on any national or regional stock exchange
or on the NASDAQ national market system or the NASDAQ Small Cap Market.
|
7.2 |
|
BAXTER. For good and valuable consideration (the receipt and
sufficiency of which is hereby acknowledged by BAXTER), BAXTER agrees to partner
exclusively with NEKTAR AL in the FIELD. Specifically, during the TERM, [***]. |
NEKTAR AL acknowledges that, [***].
Nothing set forth in this Section 7.2 shall prohibit BAXTER from owning not in
excess of 5% in the aggregate of any class of capital stock of any corporation if
such stock is publicly traded and listed on any national or regional stock exchange
or on the NASDAQ national market system or the NASDAQ Small Cap Market.
In the event that the provisions of Sections 7.1 or 7.2 should ever be deemed to
exceed the limitation provided by applicable law, then the PARTIES agree that such
provisions shall be reformed to set forth the maximum limitations permitted.
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
33
8. |
|
QUALITY AND COMPLAINTS |
|
8.1 |
|
ANALYSIS. After the RESEARCH COMMITTEES designation of a POTENTIAL
PRODUCT or a SELECTED REAGENT, the PARTIES shall cooperate and work in good faith to
establish written evaluation procedures and evaluation time lines in which to analyze
shipments of SELECTED REAGENTS and verify SELECTED REAGENT quality (including meeting
SPECIFICATIONS) using methods consistent with test procedures set forth in the
applicable QUALITY AGREEMENT. In the event the PARTIES are not able to agree upon such
procedures and timelines within [***] prior to the first PHASE 1 CLINICAL TRIAL of such
POTENTIAL PRODUCT, (i) the matter shall first be referred to the DEVELOPMENT AND
PRODUCTION COMMITTEE for resolution in accordance with Section 3.3; (ii) if within
[***] the DEVELOPMENT AND PRODUCTION COMMITTEE is unable to reach resolution, either
PARTY may elect to have a mutually acceptable laboratory or consultant establish such
procedures and time lines, whose determination thereof shall be binding; and (iii) if
within [***] the PARTIES are unable to select a mutually acceptable laboratory or
consultant, each PARTY shall select an independent consultant within [***] and such
consultants shall within [***] thereof select a mutually acceptable laboratory or
consultant to establish such time lines and procedures, whose determination thereof
shall be binding. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
34
|
8.2 |
|
ACCEPTANCE AND REJECTION. BAXTER shall notify NEKTAR AL in writing if
BAXTER believes that a shipment of SELECTED REAGENT does not comply with the testing
criteria identified pursuant to Section 8.1 above within [***] after BAXTERS receipt
of the relevant shipment of SELECTED REAGENT at BAXTERS designated destination
facility (NOTICE OF NON-CONFORMITY),
which notice shall include the basis for its assertion of such noncompliance
(including, at NEKTAR ALS request, supporting data) for purposes of consideration
and verification by NEKTAR AL. Unless otherwise set forth in the SUPPLY AGREEMENT
for the applicable SELECTED REAGENT, if no such written NOTICE OF NON-CONFORMITY is
received by NEKTAR AL within the above [***] period, BAXTER shall be deemed to have
accepted the applicable shipment of SELECTED REAGENT as meeting SPECIFICATIONS and
any other quality requirements which were verified using the agreed-upon evaluation
procedures set forth in the QUALITY AGREEMENT, which shall thereafter conclusively
be presumed to meet the SPECIFICATIONS and such quality requirements. If NEKTAR AL
receives such NOTICE OF NON-CONFORMITY within such [***] period, then NEKTAR AL will
evaluate BAXTERS NOTICE OF NON-CONFORMITY within [***] of receipt thereof and
provide a written response (RESPONSE TO NOTICE OF NON-CONFORMITY). If NEKTAR AL
fails to provide to BAXTER a RESPONSE TO NOTICE OF NON-CONFORMITY within the [***]
period, then NEKTAR AL shall be deemed to have accepted BAXTERS conclusion that the
SELECTED REAGENTS are non-conforming and waived its right to object to such
conclusion. |
If NEKTAR AL disagrees with such NOTICE OF NON-CONFORMITY, then (i) the matter
shall first be referred to the DEVELOPMENT AND PRODUCTION COMMITTEE for resolution
in accordance with Section 3.3; (ii) if the DEVELOPMENT AND PRODUCTION COMMITTEE is
not able to agree on such matter within [***], SELECTED REAGENT samples or
documentation will be supplied to a mutually acceptable laboratory or consultant
for resolution, whose determination of conformity or non-conformity shall be
binding; provided that in the event the PARTIES do not select a mutually acceptable
laboratory or consultant
within [***], each PARTY shall select an independent testing consultant within
[***] and such consultants shall select a mutually acceptable or laboratory within
[***] thereof. If the SELECTED REAGENT is determined to be non-conforming, then
[***]. If the SELECTED REAGENT is determined to be conforming, then [***].
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
35
|
8.3 |
|
REPLACEMENT OF NONCONFORMING REAGENT. NEKTAR AL shall [***], supply
BAXTER with a replacement quantity of SELECTED REAGENT in an amount equal to that
which, pursuant to the agreed upon procedures set forth herein and in the applicable
QUALITY AGREEMENT, is determined to be NONCONFORMING REAGENT. [***], BAXTER shall
promptly return all NONCONFORMING REAGENT to NEKTAR AL. Unless otherwise specified in
the applicable SUPPLY AGREEMENT, such replacement shipment shall be made within a
reasonable period of time not to exceed [***], which period of time shall be agreed
upon once the production cycle time for the applicable SELECTED REAGENT has been
established. |
|
8.4 |
|
LIABILITY TO BAXTER FOR NONCONFORMING REAGENT. |
|
8.4.1 |
|
NONCONFORMING REAGENT DETECTABLE BY TESTING. With
respect to SELECTED REAGENT that was determined to be NONCONFORMING REAGENT
through testing in accordance with the agreed-upon evaluation procedures for
the applicable SELECTED REAGENT established pursuant to Section 8.1 and the
applicable QUALITY AGREEMENT and for which BAXTER gave to NEKTAR AL a NOTICE
OF NONCONFORMITY in accordance with the requirements of Section 8.2, [***].
For clarity, if BAXTER does not comply with the procedures set forth in
Section 8.2 with respect to SELECTED REAGENT and BAXTER could
reasonably have detected that such SELECTED REAGENT was NONCONFORMING
REAGENT through testing in accordance with the agreed-upon evaluation
procedures for the applicable SELECTED REAGENT established pursuant to
Section 8.1 and the applicable QUALITY AGREEMENT, or if BAXTER otherwise
failed to comply with the notice requirements in Section 8.2 for
NONCONFORMING REAGENT, [***]. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
36
|
8.4.2 |
|
NONCONFORMING REAGENT NOT DETECTABLE BY TESTING. With
respect to (a) NEKTAR ALS negligence or willful misconduct regarding SELECTED
REAGENT or (b) SELECTED REAGENT that is NONCONFORMING REAGENT because of
breaches of the warranties set forth in Sections 6.3(ii) or (iii) that could
not reasonably have been detected through testing in accordance with the
agreed-upon evaluation procedures for the applicable SELECTED REAGENT
established pursuant to Section 8.1 and the applicable QUALITY AGREEMENT,
[***]. |
|
8.5 |
|
[INTENTIONALLY OMITTED.] |
|
8.6 |
|
FEES FOR MANUFACTURING AND SUPPLY OF SELECTED REAGENTS PRIOR TO
PIVOTAL TRIAL. |
|
8.6.1 |
|
From the date of selection of SELECTED REAGENT until the
earlier of the date of commencement of a PIVOTAL TRIAL or the date on which
the PARTIES enter into the SUPPLY AGREEMENT, BAXTER shall pay NEKTAR AL its
MANUFACTURING COST plus [***] for each SELECTED REAGENT supplied to BAXTER,
[***] (PURCHASE PRICE). BAXTER shall be entitled to audit such MANUFACTURING
COST pursuant to Section 10.2. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
37
|
8.6.2 |
|
In addition to the PURCHASE PRICE, BAXTER shall [***] as
described herein. [***]. To the extent available, NEKTAR AL shall [***]: |
|
|
|
BAXTER [***] and NEKTAR AL shall provide invoices for such fees and
services, as incurred. BAXTER shall also reimburse NEKTAR AL for NEKTAR ALS
reasonable pre-approved expenses incurred in connection with travel at
BAXTERS request. |
|
|
|
BAXTER shall be entitled to audit such fees pursuant to Section 10.2.
However, NEKTAR AL shall not be required to produce records that are not
maintained in the normal course of business. For example, if NEKTAR AL
[***]. |
|
8.6.3 |
|
BAXTER shall pay for or reimburse NEKTAR AL (as the case may
be) for such [***] services or expenses within [***] after the date of NEKTAR
ALS invoice therefor. For clarity, BAXTER shall not be responsible for any
fees, services, or travel that: (i) expand NEKTAR ALs capacity to develop or
produce PEG reagents for other customers; or (ii) do not directly or uniquely
relate to this AGREEMENT or otherwise directly benefit BAXTER. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
38
9. |
|
MILESTONES; ROYALTY PAYMENTS; ROYALTY REPORTS |
|
9.1 |
|
MILESTONE PAYMENTS. BAXTER shall pay to NEKTAR AL MILESTONES in
accordance with and pursuant to the events described in Schedule II hereto for
POTENTIAL PRODUCT and/or COMMERCIAL PRODUCT, as the case may be. Each such MILESTONE
shall be payable at the time the corresponding event occurs, and due within [***] of
the event triggering such MILESTONE. All milestones payments shall not be advance
payments against any royalties or other payments due and payable hereunder, but
shall be in addition to any royalty or other payments due under this AGREEMENT. In
the event BAXTER [***]. |
|
(i) |
|
SKIPPED MILESTONE EVENT. If, for whatever reason, a
particular milestone activity or event for which a MILESTONE is due is not
carried out, then in such case the MILESTONE that NEKTAR AL would have received
upon the occurrence of such milestone event for the POTENTIAL PRODUCT or
COMMERCIAL PRODUCT had the particular milestone event been carried out shall be
paid [***]. For example, [***]. |
|
|
(ii) |
|
[***]. |
|
(iii) |
|
NON-REFUNDABLE. Once a MILESTONE is due and payable
hereunder or once a MILESTONE is paid, BAXTER shall not have any basis for
claiming that such MILESTONE is not to be paid or is to be refunded (as the
case may be). This provision shall not preclude BAXTER from seeking to recover
damages from NEKTAR AL for the breach of this AGREEMENT. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
39
|
(iv) |
|
MARKETING AUTHORIZATION OUTSIDE OF THE FIELD. For
clarity BAXTER shall have no rights whatsoever with respect to the development,
manufacture, use, sale or importation of POTENTIAL PRODUCTS or COMMERCIAL
PRODUCTS outside of the FIELD. For clarification, BAXTER [***]. If BAXTER
desires to develop, manufacture, have manufactured, use, sell, offer for sale
or import any POTENTIAL
PRODUCT or COMMERCIAL PRODUCT outside of the
FIELD, including without limitation obtaining MARKETING AUTHORIZATION for the
addition of label claims that are outside of the FIELD for then-existing
COMMERCIAL PRODUCT(S), BAXTER shall discuss the matter with NEKTAR AL. If
NEKTAR AL (in its discretion) wishes to grant such additional rights to
BAXTER, the PARTIES shall negotiate in good faith the terms and conditions
(which may include, among other things, the payment of additional milestone
payments) applicable to the grant of such rights.
|
|
9.1.1 |
|
[***] MILESTONES FOR THE DEVELOPMENT AND
COMMERCIALIZATION OF ONE COMMERCIAL PRODUCT FOR THE TREATMENT OF
HEMOPHILIA A. The MILESTONES that are provided for under Schedule II shall
apply with respect to the first POTENTIAL PRODUCT being developed for the
treatment of Hemophilia A that achieves each such MILESTONE, and the first
COMMERCIAL PRODUCT receiving MARKETING AUTHORIZATION having a label indication
for the treatment of Hemophilia A. Such POTENTIAL PRODUCT and COMMERCIAL
PRODUCT may be the same, but in the event they are not, [***]. |
|
|
|
|
For clarity, BAXTER or its AFFILIATE or SUBLICENSEE, at BAXTERS discretion,
shall be [***]. In the event BAXTER or its AFFILIATE or SUBLICENSEE [***]. |
|
|
|
|
For example, [***], BAXTER shall [***]. |
|
|
|
|
NEKTAR AL shall not be entitled to additional MILESTONES for additional label claims that are obtained by BAXTER or its AFFILIATE or SUBLICENSEE for
then-existing COMMERCIAL PRODUCT(S) for the treatment of Hemophilia A. For
example, [***]. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
40
|
9.1.2 |
|
ADDITIONAL MILESTONES FOR THE COMMERCIALIZATION OF
MORE THAN ONE COMMERCIAL PRODUCT FOR THE TREATMENT OF HEMOPHILIA
A. After the receipt of MARKETING AUTHORIZATION for the first COMMERCIAL
PRODUCT, NEKTAR AL shall be entitled to receive milestone payments in addition
to the MILESTONES provided for in Schedule II, for each additional POTENTIAL
PRODUCT with a label indication for the treatment of Hemophilia A, for which
BAXTER or its AFFILIATE or SUBLICENSEE receives a new MARKETING AUTHORIZATION
in the United States and/or European Union. With respect to any additional
POTENTIAL PRODUCTS [***]. The amounts of such payments will be negotiated by
the PARTIES in good faith and agreed upon in a formal written amendment hereto
[***], provided that the additional milestone payments for each such additional
POTENTIAL PRODUCT [***]. |
|
|
|
|
For clarity, [***]. |
|
9.1.3 |
|
POTENTIAL PRODUCTS FOR [***]. If BAXTER elects to
develop a POTENTIAL PRODUCT to treat [***], BAXTER shall pay to NEKTAR AL
milestone payments in addition to the MILESTONES that are set forth in
Schedule II, which additional milestone payments will be negotiated by the
PARTIES in good faith and agreed upon in a formal written amendment hereto.
The additional milestone payments for such POTENTIAL PRODUCT to treat [***]
shall be agreed upon in advance but no later than
[***]. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
41
|
9.1.4 |
|
INDICATIONS FOR [***]. While NEKTAR AL shall not be
entitled to additional milestone payments for additional label claims that are
obtained by BAXTER or its AFFILIATE or SUBLICENSEE for then-existing COMMERCIAL
PRODUCT(S) within the FIELD, if BAXTER or its AFFILIATE or SUBLICENSEE seeks to
obtain [***] are for a then-existing COMMERCIAL PRODUCT with a label indication
for the [***], then in such case, additional milestone payments shall be due.
The provisions of Section 9.1.2, as they pertain to [***], shall apply such
that clinical development of COMMERCIAL PRODUCT(S) associated with obtaining
label claims for the treatment of [***] shall be deemed to constitute
development of an additional POTENTIAL PRODUCT. |
|
9.2 |
|
ROYALTIES. BAXTER shall pay NEKTAR AL royalties in an amount equal to
the product of the ROYALTY RATE and the annual aggregate NET SALES of all COMMERCIAL
PRODUCTS on a COMMERCIAL PRODUCT-by-COMMERCIAL PRODUCT and country-by-country basis for
an initial period of ten (10) years from the FIRST COMMERCIAL SALE of the applicable
COMMERCIAL PRODUCT in the applicable country (the INITIAL ROYALTY TERM). Royalties
shall be paid during the INITIAL ROYALTY TERM in each and every country where
COMMERCIAL PRODUCT is sold, without regard to whether a VALID PATENT CLAIM covers the
manufacture, use, sale, offer for sale or import of the COMMERCIAL PRODUCT or the
SELECTED REAGENT contained in such COMMERCIAL PRODUCT. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
42
|
9.2.1 |
|
After the expiration of the INITIAL ROYALTY TERM for a
particular COMMERCIAL PRODUCT in a particular country, BAXTER shall
continue to pay such royalties on NET SALES of such COMMERCIAL PRODUCT on a
world-wide basis provided that there exists, in each of the following major
markets in which MARKETING AUTHORIZATION is received for such COMMERCIAL
PRODUCT, a VALID PATENT CLAIM which would be infringed by the making, using,
having made, offering for sale, sale or importation of such COMMERCIAL
PRODUCT or the SELECTED REAGENT contained in such COMMERCIAL PRODUCT: [***]
(collectively, MAJOR MARKETS). Such royalties shall be paid on NET SALES
of COMMERCIAL PRODUCTS in those countries where the manufacture, import,
use, offer for sale or sale of the applicable COMMERCIAL PRODUCT or the
SELECTED REAGENT contained in such COMMERCIAL PRODUCT is not covered by a
VALID PATENT CLAIM, provided that the manufacture, import, use, offer for
sale or sale of such applicable COMMERCIAL PRODUCT or such SELECTED REAGENT
is covered by a VALID PATENT CLAIM in each of the MAJOR MARKETS. [***]. |
|
9.2.2 |
|
If, at the time of sale of a COMMERCIAL PRODUCT in a
particular country after the expiration of the INITIAL ROYALTY TERM in such
country, there is no VALID PATENT CLAIM covering the manufacture, use, import,
offer for sale or sale of such COMMERCIAL PRODUCT or the SELECTED REAGENT
contained in such COMMERCIAL PRODUCT in each of the MAJOR MARKETS, then BAXTER
shall only owe royalties with respect to NET SALES of COMMERCIAL PRODUCTS in
those countries in which a VALID PATENT CLAIM covers the manufacture, use,
import, offer for sale or sale of such COMMERCIAL PRODUCTS or the SELECTED
REAGENT contained in such COMMERCIAL PRODUCTS in such countries. For
example, after the expiration of the INITIAL ROYALTY TERM [***]. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
43
|
9.2.3 |
|
The PARTIES agree that a VALID PATENT CLAIM exists, for
purposes of determining whether royalties are payable after the expiration of
the INITIAL ROYALTY TERM, even if components of a COMMERCIAL PRODUCT are sold
separately as more fully described in Section 9.3 below, and the only VALID
PATENT CLAIM covers the manufacture, use, sale, offer for sale or import of
only one component of such COMMERCIAL PRODUCT ([***]). |
|
|
9.2.4 |
|
BAXTER shall [***]. |
|
9.2.5 |
|
Neither PARTY shall contest the accuracy of any royalty,
including the overpayment or underpayment of any royalty, after [***] from the
end of the calendar year in which such royalties are due and payable. For
clarity, prior to the expiration of such [***] period, BAXTER may allege the
overpayment of such royalties (and if determined that overpayment was made, be
entitled to a refund payable within [***] of NEKTAR ALS receipt of an invoice
for the overpaid amount) and NEKTAR AL may allege the underpayment of
royalties (and if determined that underpayment was made, be entitled to such
shortfall). Thereafter, the accuracy of the payment of such royalties shall be
deemed conclusively binding. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
44
|
9.3 |
|
SEPARATE COMPONENTS. If components of a COMMERCIAL PRODUCT are sold
separately, the NET SALES of such COMMERCIAL PRODUCT shall be calculated as if the
components of the COMMERCIAL PRODUCT were not sold separately; provided that no
provision of this AGREEMENT shall be construed as [***]. For example, if a COMMERCIAL
PRODUCT consists of [***] which is intended to be used with and to improve the
half-life of FACTOR VIII, the NET
SALES of such COMMERCIAL PRODUCT shall be deemed to include the amount invoiced
([***]) by BAXTER, its SUBLICENSEES and/or their respective AFFILIATES for the
FACTOR VIII with which such product is intended to be used and the [***], it being
understood and agreed that, for purposes of calculating royalties, the [***] and
the FACTOR VIII are the COMMERCIAL PRODUCT. |
|
9.4 |
|
COMMERCIAL DILIGENCE. If, during the TERM, BAXTER sells or markets
another FACTOR VIII extended half-life product using a non-PEGYLATION technology which
is used to treat Hemophilia A, then BAXTER must meet the COMMERCIAL DILIGENCE
THRESHOLD, as set forth below. No later than [***] after the FIRST COMMERCIAL SALE of a
COMMERCIAL PRODUCT in each MAJOR MARKET in which MARKETING AUTHORIZATION has been
obtained, the sales of all COMMERCIAL PRODUCTS in the aggregate shall constitute at
least [***] of the total sales of all FACTOR VIII extended half-life products used to
treat Hemophilia A in such MAJOR MARKET (the COMMERCIAL DILIGENCE THRESHOLD). If
sales of such COMMERCIAL PRODUCTS, in the aggregate, do not meet the COMMERCIAL
DILIGENCE THRESHOLD in such MAJOR MARKET within such timeframe, then [***]. In the
event [***], the ROYALTY RATE to which NEKTAR AL is otherwise entitled shall be [***].
For example, [***]. The terms of any such [***] shall be negotiated in good faith by
the PARTIES, and shall include minimum [***] and shall provide that [***]. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
45
|
9.5 |
|
REPORTS, EXCHANGE RATES. BAXTER shall notify NEKTAR AL in writing
promptly upon the FIRST COMMERCIAL SALE of each COMMERCIAL PRODUCT in each country in
which BAXTER elects to pursue commercialization. Commencing upon the FIRST COMMERCIAL
SALE of a COMMERCIAL PRODUCT, BAXTER shall furnish to NEKTAR AL a [***] showing, on a
country-by-country basis, according to the volume of units of such COMMERCIAL
PRODUCT sold in each such country (by SKU) during the reporting period: (a) the
gross invoiced sales of the COMMERCIAL PRODUCT sold in each country during the
reporting period, and the amounts deducted therefrom to determine NET SALES from
such gross invoiced sales detailed in accordance with those deductions provided for
in the definition of NET SALES; (b) the royalties payable in DOLLARS, if any, which
shall have accrued hereunder based upon the NET SALES of the COMMERCIAL PRODUCT; (c)
the withholding taxes, if any, required by LAW to be deducted in respect of such
sales; and (d) the date of the FIRST COMMERCIAL SALE of the COMMERCIAL PRODUCT in
each country during the reporting period. With respect to sales of COMMERCIAL
PRODUCT invoiced in DOLLARS, the gross invoiced sales, NET SALES, and royalties
payable shall be expressed in the report in DOLLARS. With respect to sales of
COMMERCIAL PRODUCT invoiced in a currency other than DOLLARS, the gross invoiced
sales, NET SALES and royalties payable shall be expressed in the report provided
hereunder in the domestic currency of the PARTY making the sale as well as in the
DOLLAR equivalent of the royalty payable and the exchange rate used in determining
the amount of DOLLARS. The DOLLAR equivalent shall be calculated using the average
exchange rate (local currency per DOLLAR) published in The Wall Street Journal,
Western Edition, under the heading Currency Trading, on the last business day of
each month during the applicable calendar quarter. Reports shall be due hereunder on
the forty-fifth (45th) day following the close of each calendar quarter. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
46
|
9.6 |
|
THIRD PARTY ROYALTIES, ETC. If either PARTY is required to pay
royalties or any other payments to a THIRD PARTY because the composition of matter or
method of manufacture of a SELECTED REAGENT contained in a POTENTIAL PRODUCT or
COMMERCIAL PRODUCT used, manufactured, imported, sold or offered for sale in a
particular country infringes a PATENT of such THIRD PARTY
in that country or misappropriates know-how of such THIRD PARTY in that country,
then [***] for a license under such PATENT or know-how necessary to use,
manufacture, import, sell or offer for sale such POTENTIAL PRODUCT or COMMERCIAL
PRODUCT in such country. In such event, BAXTER [***]. For example, [***] as a result
of the manufacture, use, import, export, offer for sale or sale of a SELECTED
REAGENT, POTENTIAL PRODUCT or COMMERCIAL PRODUCT, and shall be in addition to
BAXTERs obligations under Sections 15.1.2 and 17.1. In no event shall the royalties
due to NEKTAR AL on the NET SALES of COMMERCIAL PRODUCT in a country on account of
[***] pursuant to this Section 9.6 [***], except in the case where BAXTER is [***],
in which event the royalties due to NEKTAR AL on the NET SALES of COMMERCIAL PRODUCT
may be [***]. |
10. |
|
RECORDS; AUDITS; SHIPMENT TERMS; PAYMENT TERMS |
|
10.1 |
|
RECORDS. The PARTIES shall keep complete and accurate records in
sufficient detail to make the reports required hereunder, to confirm their respective
compliance with the provisions of this AGREEMENT, to properly reflect all amounts
billed, owed or reported and to verify the determination of all amounts payable
hereunder. Without limiting the foregoing, BAXTER shall include in each sublicense
granted by it pursuant to this AGREEMENT a provision requiring the SUBLICENSEE to make
reports to BAXTER consistent with those BAXTER is required to provide hereunder, to
keep and maintain records of sales made and deductions taken in calculating royalties
due to NEKTAR AL with respect to such sublicense, and to grant access to such records
by NEKTAR ALS independent accountant pursuant to Section 10.2 below to the same extent
required of BAXTER under this AGREEMENT. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
47
|
10.2 |
|
AUDITS. Upon the written request of a PARTY, the other PARTY shall
permit an independent certified public accounting firm of recognized national standing
in the
United States, selected by the requesting PARTY and reasonably acceptable to the
other PARTY, at the requesting PARTYS expense, to have access to such PARTYS
records as may be reasonably necessary to verify (i) the accuracy of any amounts
reported, actually paid or payable under this AGREEMENT, and (ii) in the case of
NEKTAR AL, BAXTERs compliance with Section 5.1, for any year ending not more than
[***] prior to the date of such request. Such audits shall be conducted under
conditions of confidentiality and may be made no more than once each calendar year,
during normal business hours at reasonable times mutually agreed by the PARTIES, and
shall not be conducted on a contingent fee basis. |
The accounting firm shall provide each PARTY with a draft of its preliminary
findings and allow each PARTY [***] to review and comment on such preliminary
report. During such period, either PARTY is free to provide the accounting firm
with additional information, which shall be considered by the accounting firm. The
accounting firm may ask for additional information and/or perform additional
procedures it deems appropriate to ensure the accuracy of its final report. Copies
of the accounting firms final report will be issued to both PARTIES.
If such accounting firm concludes that additional amounts were owed to the
requesting PARTY during such period, or if the requesting PARTY overpaid for any
rates or fees for products, the other PARTY shall pay such additional amounts or
credit such overpayment ([***]) within [***] of the date the requesting PARTY
delivers to the other PARTY such accounting firms written report so concluding.
The fees charged by such accounting firm shall be paid by the requesting PARTY;
provided however, that if the audit discloses that the amounts payable by the
audited PARTY for the audited period are more than [***] of the amounts actually
paid for such period, or if the audit discloses that the audited PARTY has
overcharged the requesting PARTY for rates or fees for products by [***], then the
audited PARTY
shall pay the reasonable fees and expenses charged by such accounting firm. Upon
the expiration of [***] following the end of any calendar year, the calculation of
any amounts payable with respect to such calendar year, or rates or fees charged
for such year shall be binding and conclusive upon the PARTIES.
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
48
|
10.3 |
|
INVOICING; PAYMENT TERMS. NEKTAR AL shall send invoices to BAXTER for
any SELECTED REAGENT shipped to BAXTER no earlier than the date of shipment. All
invoices shall be in DOLLARS. Other than as provided for in Section 9.5 with respect to
royalty payments, which shall be made within [***] after the end of each calendar
quarter as provided for therein, all payments due under this AGREEMENT shall be due and
payable [***] from date of invoice. Royalties shown to have accrued to NEKTAR AL as set
forth in each royalty report to be provided under Section 9.5 shall be due and payable
on the date such royalty report is due. Any and all amounts past due under this
AGREEMENT shall [***]. |
|
10.4 |
|
PAYMENT METHOD. Except as otherwise provided for herein, all payments
by BAXTER under this AGREEMENT shall be paid in DOLLARS, and all such payments shall be
made by electronic funds transfer in immediately available funds to such account as
NEKTAR AL shall designate before such payment is due. If at any time legal restrictions
prevent the prompt remittance of part or all royalties due with respect to sales of any
COMMERCIAL PRODUCT in any country where such COMMERCIAL PRODUCT is sold, payment shall
be made through such lawful means or methods as BAXTER shall reasonably determine. |
|
10.5 |
|
TAXES. All amounts due hereunder shall be paid net of any deduction for
withholding for any taxes or similar governmental charges imposed by any applicable
jurisdiction, and BAXTER shall provide NEKTAR AL evidence of its payment of any such
withholdings that may be required. BAXTER agrees to cooperate with and
provide reasonable assistance to NEKTAR AL in order to facilitate NEKTAR ALs
recovery of any withholdings that NEKTAR AL is due. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
49
|
11.1 |
|
TERMINATION OF NON-DISCLOSURE AGREEMENT. All provisions of, rights
granted and covenants made in the NON-DISCLOSURE AGREEMENT are hereby terminated and of
no further force and effect and are superseded in their entirety by the provisions of,
rights granted and covenants made in this AGREEMENT. The PARTIES acknowledge and agree
that any disclosure made pursuant to the NON-DISCLOSURE AGREEMENT shall be subject to
and governed by the terms and conditions of this Article 11. |
|
11.2 |
|
IN GENERAL. For the TERM and for a period of [***] thereafter, each
PARTY shall maintain in confidence all information and materials of the other PARTY
(including, but not limited to, KNOW-HOW and samples of THERAPEUTIC AGENT, CONJUGATES,
REAGENT, SELECTED REAGENT, POTENTIAL PRODUCT and COMMERCIAL PRODUCT) disclosed or
provided to it by the other PARTY (either pursuant to this AGREEMENT or the
NON-DISCLOSURE AGREEMENT). CONFIDENTIAL INFORMATION shall be identified as
confidential in writing or, if disclosed verbally or by observation, summarized in
writing and submitted to RECIPIENT within [***] of the oral or visual disclosure
thereof (together with all embodiments thereof, the CONFIDENTIAL INFORMATION).
CONFIDENTIAL INFORMATION shall include both BAXTER MATERIALS and NEKTAR AL MATERIALS.
It may also include information regarding intellectual property and confidential or
proprietary information of AFFILIATES and THIRD PARTIES. The terms and conditions of
this AGREEMENT and the NON-DISCLOSURE AGREEMENT also shall be
deemed CONFIDENTIAL INFORMATION of both PARTIES. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
50
Notwithstanding the foregoing, CONFIDENTIAL INFORMATION shall not include that
portion of information or materials that the RECIPIENT can demonstrate by
contemporaneous written records was:
|
(i) |
|
known to the general public at the time of its
disclosure to the RECIPIENT, or thereafter became generally known to
the general public, other than as a result of actions or omissions of
the RECIPIENT in violation of this AGREEMENT or the NONDISCLOSURE
AGREEMENT; |
|
(ii) |
|
known by the RECIPIENT prior to the date of
disclosure by the DISCLOSING PARTY; |
|
(iii) |
|
disclosed to the RECIPIENT on an unrestricted
basis from a source unrelated to the DISCLOSING PARTY and not known to
be under a duty of confidentiality to the DISCLOSING PARTY; or |
|
(iv) |
|
independently developed by the RECIPIENT without
the use of CONFIDENTIAL INFORMATION of the DISCLOSING PARTY. |
Any combination of features or disclosures shall not be deemed to fall within the
foregoing exclusions merely because individual features are published or known to
the general public or in the rightful possession of the RECIPIENT unless the
combination itself and principle of operation thereof are published or known to the
general public or are in the rightful possession of the RECIPIENT.
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
51
|
11.3 |
|
ADDITIONAL PROTECTIONS. Each PARTY shall take reasonable steps to
maintain the confidentiality of the CONFIDENTIAL INFORMATION of the other
PARTY, which steps shall be no less protective than those that such PARTY takes to
protect its own information and materials of a similar nature, but in no event less
than a reasonable degree of care. Neither PARTY shall use or permit the use of any
CONFIDENTIAL INFORMATION of the other PARTY except for the purposes of carrying out
its obligations or exercising its rights under this AGREEMENT. All CONFIDENTIAL
INFORMATION of a PARTY, including all copies and derivations thereof, is and shall
remain the sole and exclusive property of the DISCLOSING PARTY and subject to the
restrictions provided for herein. Neither PARTY shall disclose any CONFIDENTIAL
INFORMATION of the other PARTY other than to those of its directors, officers,
AFFILIATES, employees, licensors, independent contractors (including CONTRACT
MANUFACTURERS), SUBLICENSEES, assignees, agents and external advisors directly
concerned with the carrying out of this AGREEMENT, on a strictly applied need to
know basis. Other than as expressly permitted herein, RECIPIENT may not use
CONFIDENTIAL INFORMATION of the DISCLOSING PARTY in applying for PATENTS or securing
other intellectual property rights. |
|
11.4 |
|
PERMITTED DISCLOSURES. The obligations of Sections 11.1 and 11.2 shall
not apply to the extent that RECIPIENT is required to disclose information by LAW,
judicial order by a court of competent jurisdiction, or rules of a securities exchange
or requirement of a governmental agency for purposes of obtaining approval to test or
market POTENTIAL PRODUCT or COMMERCIAL PRODUCT (provided that the RECIPIENT shall
provide prior written notice thereof to the DISCLOSING PARTY and sufficient opportunity
for the DISCLOSING PARTY to review and comment on such required disclosure and request
confidential treatment thereof or a protective order therefor), or discloses
information to a patent office for the purposes of filing or maintaining a PATENT
APPLICATION or PATENT as permitted in this
AGREEMENT. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
52
|
11.5 |
|
IRREPARABLE INJURY. The PARTIES acknowledge that either PARTYS breach
of this Article 11 would cause the other PARTY irreparable injury for which it would
not have an adequate remedy at LAW. In the event of a breach, the nonbreaching PARTY
shall be entitled to injunctive relief in addition to any other remedies it may have at
LAW or in equity, without necessity of posting a bond. |
|
12.1 |
|
COMPLAINTS/ADVERSE EVENTS. Each PARTY shall promptly notify the other
in writing of any information that comes to its attention concerning the safety or
efficacy of any SELECTED REAGENT, POTENTIAL PRODUCT and/or COMMERCIAL PRODUCT,
including, without limitation, any threatened or pending action by any regulatory
authority with respect thereto, in accordance with the applicable QUALITY AGREEMENT. |
|
12.2 |
|
SPECIFIC REQUIREMENTS. Without limiting the generality of Section 12.1,
BAXTER shall [***]. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
53
13. |
|
REPRESENTATIONS & WARRANTIES; COVENANTS |
|
13.1 |
|
REPRESENTATIONS AND WARRANTIES. Each PARTY represents and warrants to
the other that as of the EFFECTIVE DATE to the best of its knowledge and belief: (a)
it has the full corporate power to enter into and perform this AGREEMENT; (b) this
AGREEMENT constitutes its legal, valid and binding obligation; (c) it has sufficient
legal and/or beneficial title or other rights under its intellectual property rights
to grant the licenses contained in this AGREEMENT; (d) each PARTYS professional
employees, officers, contractors (including any
CONTRACT MANUFACTURERS) and consultants that will be involved with this AGREEMENT
and the RESEARCH PLAN (and in the case of BAXTER, its AFFILIATES and SUBLICENSEES),
has executed or will execute an agreement that requires such person or entity, to
the extent permitted by LAW, to assign all INVENTIONS, PATENTS, and KNOW-HOW made
during the course of and as a result of the performance of such PARTYS obligations
under this AGREEMENT, to such PARTY; and (e) each of such PARTYS employees,
officers, contractors (including any CONTRACT MANUFACTURERS) and consultants (and
in the case of BAXTER, its AFFILIATES and SUBLICENSEES) are or will be subject to
written confidentiality obligations no less restrictive than those provided for in
this AGREEMENT. If the obligation to assign under subsection 13.1(d) is not
permitted in a particular country, then such person or entity will be required to
grant an exclusive, worldwide, perpetual, royalty-free license to all such
INVENTIONS, PATENTS, and KNOW-HOW to the PARTY to whom such assignment was to be
made, with the right to sublicense. |
|
13.2 |
|
COMPLIANCE WITH LAWS. Each PARTY will comply with all LAWS in
performing its obligations and exercising its rights hereunder. Nothing in this
AGREEMENT shall be deemed to permit BAXTER or its SUBLICENSEES to export, re-export or
otherwise transfer any information or materials (including SELECTED REAGENT or
CONJUGATES) transferred hereunder or POTENTIAL PRODUCT or COMMERCIAL PRODUCT
manufactured therefrom without complying with LAWS. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
54
14. |
|
LIMITATION OF LIABILITY; EXCLUSION OF DAMAGES |
|
14.1 |
|
LIMITATION OF LIABILITY. EXCEPT (I) FOR THE PARTIES OBLIGATIONS FOR
THIRD PARTY CLAIMS UNDER ARTICLE 15 AND (II) IN THE CASE OF A BREACH OF ARTICLE 7 OR 11: |
|
14.1.1 |
|
IN NO EVENT SHALL NEKTAR ALS LIABILITY ARISING OUT OF THIS AGREEMENT,
INCLUDING WITHOUT LIMITATION AS A RESULT OF THE RESEARCH, DEVELOPMENT,
MANUFACTURE, SUPPLY, USE OR SALE OF CONJUGATES, SELECTED REAGENTS, POTENTIAL
PRODUCTS OR COMMERCIAL PRODUCTS, EXCEED IN THE AGGREGATE, AN AMOUNT THAT IS
[***]. FOR CLARITY, [***] ARE NOT SUBJECT TO THE FOREGOING. |
|
14.1.2 |
|
IN NO EVENT SHALL A PARTY OR ITS AFFILIATES BE LIABLE TO THE OTHER PARTY OR
ITS AFFILIATES OR SUBLICENSEES FOR ANY SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE
OR CONSEQUENTIAL DAMAGES (INCLUDING WITHOUT LIMITATION, DAMAGES RESULTING FROM
LOSS OF USE, LOSS OF PROFITS, INTERRUPTION OR LOSS OF BUSINESS OR OTHER
ECONOMIC LOSS) ARISING OUT OF THIS AGREEMENT OR WITH RESPECT TO A PARTYS
PERFORMANCE OR NON-PERFORMANCE HEREUNDER. THIS REPRESENTS AN EXPRESS
ALLOCATION OF RISK BETWEEN THE PARTIES. |
|
14.2 |
|
REMEDIES. Notwithstanding anything herein to the contrary, the PARTIES
acknowledge that either PARTYS breach of Articles 7 and 11 would cause the other PARTY
irreparable injury for which it would not have an adequate remedy at LAW. In the event
of a breach, the nonbreaching PARTY shall be entitled to injunctive relief in addition
to any other remedies it may have at LAW or in equity, without necessity of posting a
bond. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
55
|
14.3 |
|
APPLICABILITY, EXCLUSIVITY OF REMEDIES. The limitations on liability
and exclusion of damages under this AGREEMENT: (i) apply even if a PARTY had or should
have had knowledge, actual or constructive, of the possibility of such damages; (ii)
are a fundamental element of the basis of the bargain between the PARTIES and this
AGREEMENT would not be entered into without such limitations and exclusions and
(iii) other than as set forth in this Article 14, shall apply whether a claim is
based on breach of contract, breach of warranty, tort (including negligence),
product liability, strict liability or otherwise, and notwithstanding any failure of
essential purpose of any limited remedy herein. Moreover, the remedies under this
AGREEMENT are intended to be exclusive, and, other than as set forth in this Article
14, the limitations on liability and exclusion of damages under this AGREEMENT are
intended to apply even if there is a total and fundamental breach of this AGREEMENT,
and the essential purpose of these provisions is to limit the PARTIES respective
liabilities hereunder. |
15. |
|
INDEMNIFICATION; INSURANCE |
|
15.1.1 |
|
BY NEKTAR AL. NEKTAR AL shall defend, indemnify and hold BAXTER,
BAXTERS SUBLICENSEES and their respective shareholders, directors, officers,
employees and agents (each, a BAXTER INDEMNITEE) harmless from and against
all losses, liabilities, damages, costs and expenses (including reasonable
attorneys fees and costs of investigation and litigation, regardless of
outcome) resulting from all claims, demands, actions and other proceedings by
or on behalf of any THIRD PARTY (including any governmental authority)
(collectively, CLAIMS) to the extent arising from: (a) the breach of any
representation, warranty, covenant or material
obligation of NEKTAR AL under this AGREEMENT; [***]. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
56
|
15.1.2 |
|
BY BAXTER. BAXTER shall defend, indemnify and hold NEKTAR AL, NEKTAR
AL AFFILIATES, and their respective shareholders, directors, officers,
employees and agents (each, a NEKTAR AL INDEMNITEE) harmless from and
against all CLAIMS to the extent arising from: (a) the breach of any
representation, warranty, covenant or material obligation of BAXTER under this
AGREEMENT; [***]. |
|
15.2 |
|
INSURANCE. Each PARTY shall, at its own expense, maintain comprehensive
general liability insurance, including product liability insurance, in the minimum
amount of [***] per occurrence, and [***] in the aggregate. BAXTER has the right to
self-insure. Any independent insurance carriers must be rated A-, VII or better by A.M.
Best Company. The PARTIES shall maintain such insurance for so long as they continue to
research or develop or manufacture or commercialize POTENTIAL PRODUCTS or COMMERCIAL
PRODUCTS, and shall from time to time provide copies of certificates of such insurance
to each other upon request. If the insurance policy is written on a claims-made basis,
then the coverage must be kept in place for at least [***] after the termination of
this AGREEMENT. |
|
15.3 |
|
PROCEDURES. If any CLAIM covered by Section 15.1 is brought, the
indemnifying PARTYS obligations are conditioned upon the following: |
|
(i) |
|
the indemnified PARTY shall promptly notify the indemnifying
PARTY in writing of such CLAIM, provided, however, the failure to provide such
notice within a reasonable period of time shall not relieve the indemnifying
PARTY of any of its obligations hereunder except if the indemnifying PARTY is
prejudiced by such failure or delay; |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
57
|
(ii) |
|
the indemnifying PARTY shall assume, at its cost and expense,
the sole defense of such CLAIM through counsel selected by the indemnifying
PARTY, except that those indemnified may at their option and expense select and
be represented by separate counsel; |
|
(iii) |
|
the indemnifying PARTY shall maintain control of such defense
and/or the settlement of such CLAIM, and the indemnified PARTY shall cooperate
with the indemnifying PARTY; |
|
(iv) |
|
those indemnified may, at their option and expense, participate
in such defense, and if they so participate, the indemnifying PARTY and those
indemnified shall cooperate with one another in such defense; |
|
(v) |
|
the indemnifying PARTY will have authority to consent to the
entry of any monetary judgment, to enter into any settlement or otherwise to
dispose of such CLAIM (provided and only to the extent that an indemnified
PARTY does not have to admit liability and such judgment does not involve
equitable relief), and an indemnified PARTY may not consent to the entry of any
judgment, enter into any settlement or otherwise to dispose of such CLAIM
without the prior written consent of the indemnifying PARTY; and |
|
(vi) |
|
the indemnifying PARTY shall pay the full amount of any
judgment, award or settlement with respect to such CLAIM and all other costs,
fees and expenses related to the resolution thereof; provided that such other
costs, fees and expenses have been incurred or agreed, as the case may be, by
the indemnifying PARTY in its defense or settlement of the CLAIM. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
58
16. |
|
INVENTIONS, KNOW-HOW and PATENTS |
|
16.1 |
|
EXISTING INTELLECTUAL PROPERTY. Other than as expressly provided in
this AGREEMENT, neither PARTY grants nor shall be deemed to grant any right, title or
interest to the other PARTY in any PATENT, PATENT APPLICATION, KNOW-HOW or other
intellectual property right CONTROLLED by such PARTY as of the EFFECTIVE DATE. |
|
16.2 |
|
DISCLOSURE. Each PARTY shall promptly disclose in writing to the other
all INVENTIONS arising from the joint or separate activities (including any INVENTIONS
conceived or first reduced to practice as a result of such activities) of the PARTIES
or their agents, employees, SUBLICENSEES or independent contractors (including CONTRACT
MANUFACTURERS) during and in connection with the performance of their obligations or
activities under this AGREEMENT (including in carrying out its activities under the
RESEARCH PLAN and the development or manufacture of POTENTIAL PRODUCT or COMMERCIAL
PRODUCT); provided, however, that [***]. |
|
16.3 |
|
OWNERSHIP OF INVENTIONS. Except as otherwise set forth in Sections 16.4
or 16.5, all INVENTIONS conceived or first reduced to practice solely by employees,
agents, SUBLICENSEES or independent contractors (including CONTRACT MANUFACTURERS) of a
PARTY during the course and in the performance of this AGREEMENT (including in carrying
out its activities under the RESEARCH PLAN and the development or manufacture of
POTENTIAL PRODUCT or COMMERCIAL PRODUCT) (each, a SOLE INVENTION) shall be the
exclusive property of such PARTY. Except as otherwise set forth in Sections 16.4 or
16.5, if employees, agents, SUBLICENSEES or independent contractors (including CONTRACT
MANUFACTURERS) of each of NEKTAR AL and BAXTER jointly, conceive or first reduce to
practice any INVENTION during the course and in the performance of activities conducted
in connection with this AGREEMENT (including in carrying out its activities |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
59
under the RESEARCH PLAN and the
development or manufacture of POTENTIAL PRODUCT or COMMERCIAL PRODUCT) (each, a
JOINT INVENTION) then such JOINT INVENTION, and any PATENT APPLICATION or PATENT
claiming the same shall be [***] JOINT INVENTION, and any PATENT APPLICATION or
PATENT claiming the same, [***]. For the avoidance of doubt, the determination as to
whether an INVENTION has been solely or jointly made shall be based upon whether
employees, agents, SUBLICENSEES or independent contractors (including CONTRACT
MANUFACTURERS) of a PARTY would be or are properly named as an inventor on a
corresponding PATENT APPLICATION under United States inventorship LAWS. Any JOINTLY
OWNED TECHNOLOGY, regardless of whether such INVENTION is conceived or first reduced
to practice solely or jointly by employees, agents, SUBLICENSEES or independent
contractors (including CONTRACT MANUFACTURERS) of each of NEKTAR AL and BAXTER,
shall be considered a JOINT INVENTION for the purposes of this AGREEMENT.
|
16.4 |
|
NEKTAR AL CORE TECHNOLOGY INVENTIONS. Any and all rights, title and
interest in and to all SOLE INVENTIONS and JOINT INVENTIONS (except those JOINT
INVENTIONS that are JOINTLY OWNED TECHNOLOGY), which fall solely within the scope of
NEKTAR AL CORE TECHNOLOGY, shall belong solely to NEKTAR AL (NEKTAR AL CORE TECHNOLOGY
INVENTIONS). BAXTER hereby agrees to and hereby does, and shall, without additional
consideration transfer and assign to NEKTAR AL all of its right, title and interest in
and to such NEKTAR AL CORE TECHNOLOGY INVENTIONS and all intellectual property rights
therein including enforcement rights, and shall require its employees, agents,
SUBLICENSEES and independent contractors (including CONTRACT MANUFACTURERS) to so
assign their right, title and interest therein to NEKTAR
AL. NEKTAR AL shall be responsible, [***], for the filing, prosecution and
maintenance of foreign and domestic PATENT APPLICATIONS and PATENTS covering such
NEKTAR AL CORE TECHNOLOGY INVENTIONS. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
60
|
16.5 |
|
BAXTER CORE TECHNOLOGY INVENTIONS. Any and all rights, title and
interest in and to all SOLE INVENTIONS and JOINT INVENTIONS (except those JOINT
INVENTIONS that are JOINTLY OWNED TECHNOLOGY), which fall solely within the scope of
BAXTER CORE TECHNOLOGY, shall belong solely to BAXTER (BAXTER CORE TECHNOLOGY
INVENTIONS). NEKTAR AL hereby agrees to and hereby does, and shall, without additional
consideration assign to BAXTER all of its right, title and interest in and to any
BAXTER CORE TECHNOLOGY INVENTIONS and all intellectual property rights therein
including enforcement rights, and shall require its employees, agents or independent
contractors (including CONTRACT MANUFACTURERS) to so assign their right, title and
interest therein to BAXTER. BAXTER shall be responsible, [***], for the filing,
prosecution and maintenance of foreign and domestic PATENT APPLICATIONS and PATENTS
covering such BAXTER CORE TECHNOLOGY INVENTIONS. |
|
16.6 |
|
INDIVIDUAL PATENT FILINGS. Each PARTY shall have sole discretion and
right to prepare, file, prosecute, maintain and defend PATENT APPLICATIONS or PATENTS
for INVENTIONS it solely owns under this AGREEMENT, and shall be responsible for
related interference proceedings. [***]. Costs incurred with respect to PATENT
APPLICATIONS shall be borne by the PARTY with the right to prosecute each such PATENT
APPLICATION. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
61
|
16.7 |
|
JOINT PATENT FILINGS. With respect to all PATENT APPLICATIONS on JOINT
INVENTIONS that are jointly owned by the PARTIES (i.e., JOINT INVENTIONS that have not
been assigned nor are assignable to the other PARTY
pursuant to Sections 16.4 and 16.5) (the JOINT PATENT APPLICATIONS), the PARTIES
shall determine which PARTY shall be responsible for filing, prosecuting and
maintaining PATENT APPLICATIONS and PATENTS on behalf of both PARTIES (the
RESPONSIBLE PARTY) [***]. All PATENTS issuing from such PATENT APPLICATIONS shall
be defined as JOINT PATENTS. It is understood that BAXTER shall have the
preferential right to prosecute those JOINT INVENTIONS directed solely at POTENTIAL
or COMMERCIAL PRODUCTS. At least [***] prior to the contemplated filing of such
PATENT APPLICATION, the RESPONSIBLE PARTY shall submit a substantially completed
draft of the JOINT PATENT APPLICATION to the other PARTYs patent attorneys only for
its approval, which shall not be unreasonably withheld or delayed. Except as set
forth below, [***] of the preparation, filing, prosecution and maintenance of all
JOINT PATENT APPLICATIONS. [***] of preparing, filing, prosecuting and maintaining
all of the foreign and domestic JOINT PATENT APPLICATIONS that cover INVENTIONS
within the scope of JOINTLY OWNED TECHNOLOGY, and the JOINT PATENTS that issue
therefrom. |
|
16.8 |
|
DISPOSITION OF INVENTIONS. It is understood and agreed that for the
purposes of this AGREEMENT, even if an employee, agent, SUBLICENSEE or contractor of a
PARTY is an inventor of an INVENTION that is claimed in a PATENT or PATENT APPLICATION,
the PARTY who owns said INVENTION as a result of the operation of Article 16 shall not
assign, transfer, license or otherwise dispose of any other claim in such PATENT or
PATENT APPLICATION, unless such PARTY solely or jointly owns or otherwise has the right
to license rights with respect to said other claim (in each case as expressly provided
for in this AGREEMENT). |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
62
|
16.9 |
|
FURTHER ACTIONS. Each PARTY shall cooperate with the other PARTY to
execute all documents and take all reasonable actions to effect the intent of this
Article 16. |
|
16.10 |
|
PATENT MARKING AND POTENTIAL PRODUCT AND COMMERCIAL PRODUCT MARKING. |
|
(i) |
|
BAXTER shall place appropriate NEKTAR AL patent and/or patent
pending markings on each POTENTIAL PRODUCT and COMMERCIAL PRODUCT or the
packaging therefor. The content, form, size, location and language of such
markings shall be in accordance with the LAWS and practices of the country in
which the applicable units of each POTENTIAL PRODUCT or COMMERCIAL PRODUCT are
distributed. |
|
(ii) |
|
BAXTER shall be responsible for all packaging (non-commercial
and commercial) and labeling of POTENTIAL PRODUCT or COMMERCIAL PRODUCT. To the
extent allowed by LAWS, all POTENTIAL PRODUCT or COMMERCIAL PRODUCT labeling,
packaging and package inserts and any promotional materials associated with the
POTENTIAL PRODUCT or COMMERCIAL PRODUCT shall carry, in a conspicuous location,
the trademark of NEKTAR AL, the identity and style of which shall be at NEKTAR
ALS sole discretion. NEKTAR AL authorizes the use of its trademark pursuant to
this Section 16.10(ii). |
|
16.11 |
|
SUPPLEMENTAL PATENT PROTECTION. [***]. Such protection shall include
the listing of any requested [***] in any book, or book equivalent, of any country
necessary for extending the term of such [***]. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
63
|
17.1 |
|
INFRINGEMENT OF THIRD PARTY RIGHTS. |
|
17.1.1 |
|
NOTICE. If the development, manufacture, use, import, sale or offer
for sale of a POTENTIAL PRODUCT or a COMMERCIAL PRODUCT results in a claim for
PATENT infringement by a THIRD PARTY, the PARTY to this AGREEMENT first having
notice shall promptly notify the other PARTY in writing. The notice shall set
forth the facts of the claim in reasonable detail. |
|
17.1.2 |
|
LITIGATION UNRELATED TO SELECTED REAGENT. Except to the extent any
infringement of patents or misappropriation of know-how results solely from
the composition of matter or the method of manufacture of a SELECTED REAGENT,
[***] from and against all losses, liabilities, damages, costs and expenses
(including reasonable attorneys fees and costs of investigation and
litigation, regardless of outcome) resulting from any claim that the
development, manufacture, use, import, offer for sale or sale of a POTENTIAL
PRODUCT or a COMMERCIAL PRODUCT infringes a THIRD PARTY patent or
misappropriates THIRD PARTY know-how, and the provisions of Sections 15.1.2
and 15.3 shall apply with respect to any such claim to the same extent as
though it were a CLAIM [***]. In the event of a conflict between the
provisions of Article 15 and this Section 17.1.2, [***]. |
|
17.1.3 |
|
LITIGATION RELATED TO SELECTED REAGENT. If infringement of a THIRD
PARTY patent or misappropriation of THIRD PARTY know-how is alleged solely
because the composition of the SELECTED REAGENT or the method of making the
same, is used in the development, manufacture, use, offer for sale, sale, or
import of a POTENTIAL PRODUCT or COMMERCIAL PRODUCT, [***], any such action
taken by such THIRD PARTY against either PARTY or both PARTIES, including the
costs and expenses (including reasonable attorneys fees and costs of
investigation and
litigation, regardless of outcome) resulting from such defense. [***]. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
64
|
17.2 |
|
INFRINGEMENT BY THIRD PARTIES. |
|
17.2.1 |
|
NOTICE OF INFRINGEMENT. If any VALID PATENT CLAIM is infringed by a
THIRD PARTY, or any KNOW-HOW utilized in the manufacture, use, import, offer
for sale or sale of SELECTED REAGENT or POTENTIAL PRODUCT or COMMERCIAL
PRODUCT is misappropriated by a THIRD PARTY, the PARTY first having knowledge
of such infringement or misappropriation shall promptly notify the other PARTY
in writing. The notice shall set forth the facts of such infringement or
misappropriation in reasonable detail. |
|
|
17.2.2 |
|
PROSECUTION OF ACTIONS RELATED TO SELECTED REAGENT. |
|
A. |
|
NEKTAR AL shall have the right, but not the
obligation, to carry out actions against THIRD PARTIES arising from such
THIRD PARTIES infringement or misappropriation of NEKTAR AL LICENSED
TECHNOLOGY covering the manufacture, use, import, offer for sale or sale
of a SELECTED REAGENT. [***]. |
|
B. |
|
If NEKTAR AL fails to bring an action or
proceeding within a period of [***] after receiving written notice from
BAXTER of the possibility of a claim, or otherwise having knowledge of a
claim described in Section 17.2.2(A), BAXTER shall have the right, but
not the obligation, to bring and control any such action using counsel
of its own choice, [***]. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
65
|
C. |
|
AWARDS. If either PARTY brings an action
for infringement or
misappropriation by a THIRD PARTY under this Section 17.2.2 any
damages or other monetary awards or payments in settlement recovered
by such PARTY shall be applied first to defray the costs and
expenses incurred by both PARTIES in the action. Any remainder shall
be shared by the PARTIES as follows: [***], when the action for
infringement or misappropriation relates to a COMMERCIAL PRODUCT;
and [***]. |
|
17.2.3 |
|
PROSECUTION OF ACTIONS RELATED TO THE FIELD. |
|
A. |
|
Except as set forth in Section 17.2.2, BAXTER
shall have the primary right, but not the obligation, to carry out
actions against THIRD PARTIES arising from such THIRD PARTIES
infringement or misappropriation of NEKTAR AL LICENSED TECHNOLOGY in
the FIELD, including the manufacture, use, import, offer for sale or
sale of a POTENTIAL PRODUCT or COMMERCIAL PRODUCT. [***]. |
|
B. |
|
If BAXTER fails to bring an action or proceeding
within a period of sixty (60) days after receiving written notice from
NEKTAR AL of the possibility of a claim, or otherwise having knowledge
of a claim described in Section 17.2.3(A), NEKTAR AL shall have the
right, but not the obligation, to bring and control any such action
using counsel of its own choice, [***]. |
|
C. |
|
AWARDS. If either PARTY brings an action
for infringement or misappropriation by a THIRD PARTY under this
Section 17.2.3 any damages or other monetary awards or payments in
settlement recovered by such PARTY shall be applied first to defray the
costs and
expenses incurred by both PARTIES in the action. Any remainder shall
be shared by the PARTIES as follows: [***].
|
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
66
18. |
|
[INTENTIONALLY OMITTED] |
|
19. |
|
TERM AND TERMINATION |
|
19.1 |
|
EXPIRATION. The term of this AGREEMENT (the TERM) shall commence on
the EFFECTIVE DATE and shall continue until terminated as set forth herein. Once a
POTENTIAL PRODUCT is a COMMERCIAL PRODUCT and has been commercialized, this AGREEMENT
shall expire on a country-by-country basis upon the expiration of all royalty
obligations with respect to such COMMERCIAL PRODUCT in the applicable country, unless
earlier terminated as provided herein. Upon the expiration of royalty obligations with
respect to a COMMERCIAL PRODUCT in any applicable country, BAXTER is hereby granted by
NEKTAR AL a paid-up, exclusive, royalty-free, perpetual, non-cancelable, license, with
rights to sublicense, in the FIELD under the NEKTAR AL LICENSED TECHNOLOGY to make,
have made, use, sell, offer for sale and import such COMMERCIAL PRODUCT in such
country, [***]. The terms and conditions of such manufacture and supply of SELECTED
REAGENT shall be negotiated in good faith by the PARTIES. |
|
19.2 |
|
DISCRETIONARY TERMINATION. [***], other than pursuant to any other
provision of this AGREEMENT, [***], payable in accordance with Section 19.7.5, upon
[***]. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
67
|
19.3 |
|
TERMINATION FOR CAUSE. Each PARTY shall have the right to terminate
this AGREEMENT by written notice to the other PARTY for a failure to comply with the
material terms of this AGREEMENT by the other PARTY, provided such failure to
comply is not corrected by the failing PARTY within: (i) [***] of written notice of
any failure to make timely payment of royalties or any other amount that is not in
dispute, when due hereunder, or (ii) [***] of receipt of written notice of any other
failure from the non-failing PARTY. |
|
19.4 |
|
TERMINATION FOR INSOLVENCY. Either PARTY may terminate this AGREEMENT
immediately by written notice in the event: (i) the other PARTY voluntarily enters into
bankruptcy proceedings; (ii) the other PARTY makes an assignment for the benefit of
creditors; (iii) a petition is filed against the other party under a bankruptcy law, a
corporate reorganization law, or any other law for relief of debtors or similar law
analogous in purpose or effect, which petition is not stayed or dismissed within [***]
of filing thereof; or (iv) the other PARTY enters into liquidation or dissolution
proceedings or a receiver is appointed with respect to any assets of the other PARTY,
which appointment is not vacated within [***] (herein a BANKRUPTCY PROCEEDING). |
|
19.5 |
|
TERMINATION/[***] FOR LACK OF DILIGENCE. In the event [***]. In the
event [***] provided for herein shall continue to apply, except as otherwise set forth
in Section 19.5.2. Notwithstanding the foregoing, before [***] may provide notice of
termination of the AGREEMENT or termination of [***] shall call a special meeting of
the JOINT STEERING COMMITTEE for the sole purpose of discussing the reasons for [***].
Such special meeting of the JOINT STEERING COMMITTEE shall be held [***]. At any time
during the period commencing on the conclusion of such meeting up through the date that
is [***]. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
68
|
19.5.1 |
|
An ACCEPTABLE DELAY shall be the failure to meet a Development Diligence
milestone event due to: |
|
A. |
|
an event of force majeure as described in Section 22.1; |
|
B. |
|
any breach by NEKTAR AL, or NEKTAR AL delay,
that materially adversely affects BAXTERs ability to meet a relevant
Development Diligence milestone event; |
|
C. |
|
a dispute or disagreement in one or more of the
governance committees (JOINT STEERING COMMITTEE, RESEARCH COMMITTEE,
DEVELOPMENT AND PRODUCTION COMMITTEE) which is [***]; |
|
D. |
|
a regulatory requirement that comes into effect
after the EFFECTIVE DATE; |
|
E. |
|
a development issue involving safety, toxicity,
efficacy or pharmacokinetics, or the ability to scale up to commercial
manufacturing (including the inability to obtain commercially viable
yields); |
|
F. |
|
any other delay deemed to be an ACCEPTABLE DELAY
by both PARTIES in writing, the intent of which is to be inclusive of
unanticipated delays outside of the control of BAXTER; or |
|
G. |
|
[***] in accordance with the timelines set forth
in the RESEARCH PLAN, [***]. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
69
In the event the PARTIES cannot agree whether a delay is outside the control of
BAXTER and deemed an ACCEPTABLE DELAY, (i) either PARTY may refer the matter to the
JOINT STEERING COMMITTEE for resolution, (ii) if the JOINT STEERING COMMITTEE
cannot resolve such matter within [***], then the matter shall be sent to the
PARTIES [***] for resolutions, (iii) if [***], then the PARTIES
shall refer the matter to a [***] and/or significant professional experience with
respect to the specific subject matter under dispute, such professional shall make
a determination within [***] of being selected by the PARTIES and such
professionals determination shall be conclusive and binding on the PARTIES.
In the case of an ACCEPTABLE DELAY, and except as otherwise set forth in Section
19.5.1(G), the [***]. In the event [***] due to one or more of these events, the
[***].
|
(i) |
|
[***]; |
|
|
(ii) |
|
[***]; |
|
|
(iii) |
|
[***]; |
|
|
(iv) |
|
[***]. |
|
19.5.2 |
|
If, at the time that [***] elects to exercise its rights to terminate this
AGREEMENT [***] solely for the treatment of [***]. In such event, the following
shall occur: |
|
(i) |
|
The definition of FIELD in Section 1.26 shall automatically be
narrowed to consist only of [***] for use alone for the treatment of
[***]; |
|
(ii) |
|
The definition of THERAPEUTIC AGENT shall
automatically be limited to [***]; |
|
(iv) |
|
All royalty and milestone provisions applicable
to such POTENTIAL PRODUCTS and COMMERCIAL PRODUCTS shall remain in
effect. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
70
|
19.6 |
|
TERMINATION ON CHALLENGE. [***] may terminate this AGREEMENT by giving
written notice to [***] challenging the validity of any of the [***]; provided that
[***] may not exercise such termination rights if [***] (whether under contract or
other legal theory) [***] allege in defense of such claim or action that the COMMERCIAL
PRODUCT does not infringe a VALID PATENT CLAIM. |
|
19.7 |
|
EFFECT OF TERMINATION. |
|
19.7.1 |
|
The provisions of Articles [***] (and in each case together with any defined
terms applicable to such provisions) shall survive expiration or termination
of this AGREEMENT for any reason whatsoever. |
|
19.7.2 |
|
Notwithstanding anything in this AGREEMENT to the contrary, if this AGREEMENT
is terminated for any reason other than for cause [***]: |
|
A. |
|
[***]; |
|
|
B. |
|
[***]; |
|
|
C. |
|
BAXTER shall pay NEKTAR AL all
earned milestone payments and accrued royalties in accordance
with the terms of this AGREEMENT; |
|
|
D. |
|
[***] Subject to the foregoing,
if this AGREEMENT is terminated for any reason whatsoever, any
licenses and sublicenses granted under this AGREEMENT shall
automatically terminate and all licensed rights shall revert
in their entirety to the respective licensor; and |
|
|
E. |
|
Termination of this AGREEMENT by
a PARTY shall not be an exclusive remedy and all other remedies
will be available to the terminating PARTY, in equity and at
LAW, subject to the limitations and exclusions that are
provided for in this AGREEMENT. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
71
|
19.7.3 |
|
If this AGREEMENT is terminated by [***], then on the effective date of such
termination, [***], including any of the intellectual property rights therein,
including any JOINT PATENT APPLICATIONS and JOINT PATENTS covering such
JOINTLY OWNED TECHNOLOGY. As of the effective date of such termination, [***]
shall have the sole right, as between NEKTAR AL and BAXTER, to bring actions
against THIRD PARTIES arising from such THIRD PARTIES infringement or
misappropriation of JOINTLY OWNED TECHNOLOGY. [***]. |
|
19.7.4 |
|
In the event of a BANKRUPTCY PROCEEDING, NEKTAR AL hereby agrees to grant
and hereby grants to BAXTER and its AFFILIATES, and the PARTIES agree that
this AGREEMENT shall be deemed an executory contract and that BAXTER and its
AFFILIATES shall be deemed to retain, an exclusive, perpetual, non-cancelable,
license, with rights to sublicense as provided for herein, in the FIELD under
the NEKTAR AL LICENSED TECHNOLOGY to develop, make, have made, import, export,
use, sell and have sold POTENTIAL PRODUCTS and COMMERCIAL PRODUCT(S) in the
FIELD; provided that BAXTER shall continue to fulfill its MILESTONES and
royalty payment obligations under this AGREEMENT.
BAXTER agrees to pay NEKTAR AL, or any trustee, in such BANKRUPTCY
PROCEEDING a royalty for such a license equivalent to the license royalty
provision provided in this AGREEMENT. In addition to the surviving Sections
in Section 19.7.1, Sections 9.2, 9.3, 9.5 and 9.6 shall survive termination
or expiration of this Agreement. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
72
|
19.7.5 |
|
TERMINATION FEE. If this AGREEMENT is terminated by BAXTER under
Section 19.2, BAXTER shall pay to NEKTAR AL a termination fee (TERMINATION
FEE) within [***] after the effective date of such termination as follows:
(i) if such termination occurs prior to the payment to NEKTAR AL of all of the
[***], then the TERMINATION FEE shall be equal to [***], (ii) if such
termination occurs after payment to NEKTAR AL of all of the [***], then the
TERMINATION FEE shall be [***]; (iii) if such termination occurs after the
successful completion of the [***], then the TERMINATION FEE shall be [***];
and (iv) if such termination occurs after the successful completion of the
[***], then the TERMINATION FEE shall be [***]. In addition to the foregoing
and, if applicable, if a COMMERCIAL PRODUCT is not launched within [***] after
the date on which [***]. Notwithstanding the foregoing, if BAXTER terminates
the AGREEMENT under Section 19.2 due to a COMMERCIAL FAILURE, the TERMINATION
FEE [***]. COMMERCIAL FAILURE means: |
|
(i) |
|
[***]; |
|
|
(ii) |
|
[***]; |
|
|
(iii) |
|
[***]; |
|
|
(iv) |
|
[***]; |
|
|
(v) |
|
[***]; |
|
|
(vi) |
|
[***]. |
For clarity, if this AGREEMENT is terminated by BAXTER in connection with a COMMERCIAL
FAILURE, there shall be [***].
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
73
20. |
|
ASSIGNMENT |
|
|
|
Unless otherwise expressly permitted hereunder, neither PARTY may assign any of its rights
or delegate any of its duties under this AGREEMENT without the prior written consent of the
other PARTY, except that either PARTY may assign any or all of its rights and/or
responsibilities hereunder without the other PARTYS consent as part of: (i) the sale of all
or substantially all of the assets or the entire business to which this AGREEMENT relates,
(ii) a merger, consolidation, reorganization or other combination with or into another
person or entity; or (iii) the transfer or assignment to an AFFILIATE, in each case,
pursuant to which the surviving entity or assignee assumes the assigning or merging PARTYS
obligations hereunder. Any assignment made in violation of this Article 20 shall be null and
void. |
|
21. |
|
NOTICES |
|
|
|
Wherever notice is required or permitted hereunder, it shall be by personal delivery, first
class mail, overnight delivery service, or sent by facsimile transmission, with electronic
confirmation, properly directed to the PARTY at its address and contact information listed
below. Said address and contact information may be changed from time to time by similar
written notice. |
If to BAXTER, addressed to:
Baxter Healthcare Corporation One
Baxter Parkway
Deerfield, Illinois 60015
Attention: [***]
Telephone: [***]
Facsimile: [***]
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
74
Baxter Healthcare SA
CH-8304 Wallisellen
Zurich, Switzerland
Attention: [***]
Telephone: [***]
Facsimile: [***]
With copies to:
Baxter Healthcare Corporation
One Baxter Parkway
Deerfield Illinois 60015
Attention: [***]
Telephone: [***]
Facsimile: [***]
Baxter Healthcare SA
CH-8304 Wallisellen
Zurich, Switzerland
Attention: [***]
Telephone: [***]
Facsimile: [***]
If to NEKTAR AL, addressed to:
NEKTAR Therapeutics AL, Corporation
1112 Church Street
Huntsville, AL 35801
Attention: [***]
Facsimile: [***]
With a copy to: [***]
Nektar Therapeutics
150 Industrial Road
San Carlos, CA 94070-6256
Attention: [***]
Facsimile: [***]
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
75
|
22.1 |
|
FORCE MAJEURE. Except for each PARTYs confidentiality and indemnity
obligations, the obligations of either PARTY under this AGREEMENT shall be excused
during each period of delay caused by matters such as acts of God, strikes, supplier
delays, failure of utilities or common carriers, shortages of raw materials,
government orders, sufferance of or voluntary compliance with acts of government or
governmental regulation, or acts of war or terrorism, which are reasonably beyond the
control of the PARTY obligated to perform. Force majeure shall not include a lack of
funds, bankruptcy or other financial cause or disadvantage, and force majeure shall
not excuse or delay any PARTYS payment obligations under this AGREEMENT. Nothing
contained in this AGREEMENT shall affect either PARTYs ability or discretion
regarding any strike or other employee dispute or disturbance and all such strikes,
disputes or disturbances shall be deemed to be beyond the control of such PARTY. A
condition of force majeure shall be deemed to continue only so long as the affected
PARTY shall be taking all reasonable actions necessary to overcome such condition. If
either PARTY shall be affected by a condition of force majeure, such PARTY shall give
the other PARTY prompt notice thereof, which notice shall contain the affected PARTYS
estimate of the duration of such condition and a description of the steps being taken
or proposed to be taken to overcome such condition of force majeure. Any delay
occasioned by any such cause shall not constitute a default, breach or failure under
this AGREEMENT, and the obligations of the PARTIES shall be suspended during the
period of delay so occasioned. During any period of force majeure, the PARTY that is
not directly affected by such condition of force majeure may take any reasonable
action
necessary to mitigate the effects of such condition of force majeure. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
76
|
22.2 |
|
SEVERABILITY. All the terms and provisions of this AGREEMENT are
distinct and severable, and if any term or provision is held unenforceable, illegal or
void in whole or in part by any court, regulatory authority or other competent
authority it shall to that extent be deemed not to form part of this AGREEMENT, and the
enforceability, legality and validity of the remainder of this AGREEMENT shall not be
affected thereby. |
|
22.3 |
|
VARIATION. This AGREEMENT may not be amended, varied or modified in any
manner except by an instrument in writing signed by a duly authorized officer or
representative of each PARTY hereto. |
|
22.4 |
|
FORBEARANCE AND WAIVER. No waiver by a PARTY in respect of any breach
shall operate as a waiver in respect of any subsequent breach. No forbearance, failure
or delay by a PARTY in exercising any right or remedy shall operate as a waiver
thereof, nor shall any single or partial forbearance, exercise or waiver of any right
or remedy prejudice its further exercise of any right or remedy under this AGREEMENT or
at LAW. |
|
22.5 |
|
COUNTERPARTS; FACSIMILE. This AGREEMENT may be executed in more than
one counterpart, each of which constitutes an original and all of which together shall
constitute one enforceable agreement. For purposes of this AGREEMENT and any other
document required to be delivered pursuant to this AGREEMENT, facsimiles of signatures
shall be deemed to be original signatures. In addition, if any of the PARTIES sign
facsimile copies of this AGREEMENT, such copies shall be deemed originals. |
|
|
|
[***] |
|
indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
77
|
22.6 |
|
NO PARTNERSHIP. The relationship of the PARTIES is that of independent
contractors and this AGREEMENT shall not operate so as to create a partnership or
joint venture of any kind between the PARTIES. |
|
22.7 |
|
CONSTRUCTION. The PARTIES have participated jointly in the negotiation
and drafting of this AGREEMENT. In the event that an ambiguity or question of intent or
interpretation arises, this AGREEMENT shall be construed as if drafted jointly by the
PARTIES and no presumption or burden of proof shall arise favoring or disfavoring any
PARTY by virtue of the authorship of any of the provisions of this AGREEMENT. Except
where the context otherwise requires, where used, the singular shall include the
plural, the plural the singular, the use of any gender shall be applicable to all
genders and the word or is used in the inclusive sense (and/or). The captions of this
AGREEMENT are for convenience of reference only and in no way define, describe, extend
or limit the scope or intent of this AGREEMENT or the intent of any provision contained
in this AGREEMENT. The term includes and including as used herein means including,
but not limited to. |
|
22.8 |
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ENTIRE AGREEMENT. This AGREEMENT and the Schedules and Exhibit attached
hereto constitute the entire understanding between the PARTIES and supersedes any prior
or contemporaneous written or oral understanding, negotiations or agreements between
and among them respecting the subject matter hereof. This AGREEMENT may not be modified
or amended other than by a writing signed by both PARTIES duly authorized officers.
This AGREEMENT shall be binding upon, and inure to the benefit of, the PARTIES and
their respective successors and assigns. |
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[***] |
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indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
78
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22.9 |
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GOVERNING LAW. This AGREEMENT shall be governed by and construed in
accordance with the LAWS of the State of California without regard to its or any other
jurisdictions choice of law rules. Any disputes under this AGREEMENT shall be brought
in the state or federal courts located in California. The PARTIES submit to
the personal jurisdiction of such courts for any such action, agree that such courts
provide a convenient forum for any such action, and waive any objections or
challenges to venue with respect to such courts. |
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22.10 |
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PUBLICITY. Neither PARTY shall make any public announcement concerning
this AGREEMENT without the prior written consent of the other PARTY, unless counsel to
such PARTY advises that such announcement or statement may be required by LAW
(including applicable stock exchange rule). In the case of an announcement required by
LAW, the other PARTY shall be advised in advance and both PARTIES shall use good faith
efforts to cause a mutually agreeable announcement to be issued in a timely basis.
Notwithstanding the foregoing, NEKTAR AL and BAXTER shall prepare and issue a joint
press release acceptable to both PARTIES announcing the relationship created under this
AGREEMENT. |
[Signature Page Follows.]
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[***] |
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indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
79
IN WITNESS WHEREOF, the PARTIES hereto have caused their authorized representatives to execute
this AGREEMENT by signing below:
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Signed: |
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For and on behalf of:
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For and on behalf of: |
NEKTAR Therapeutics AL, Corporation
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Baxter Healthcare Corporation |
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Signature [***]
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Signature [***] |
Name: [***]
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Name: [***] |
Title: [***]
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Title: [***] |
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For and on behalf of: |
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Baxter Healthcare SA |
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Signature [***] |
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Name: [***] |
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Title: [***]
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[***] |
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indicates that certain information contained herein has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions. |
80
AMENDMENT NO. 1 TO EXCLUSIVE RESEARCH, DEVELOPMENT, LICENSE
AND MANUFACTURING AND SUPPLY AGREEMENT
This Amendment No. 1 to Exclusive Research, Development, License and Manufacturing and Supply
Agreement (the Amendment) is made and entered into effective as of October 19, 2005 (the
Effective Date of the Amendment), by and between Nektar Therapeutics AL, Corporation, (Nektar)
and Baxter Healthcare SA and Baxter Healthcare Corporation (collectively, Baxter). Nektar and
Baxter may be referred to herein as a Party or, collectively, as Parties.
RECITALS
WHEREAS, Nektar and Baxter are parties to an Exclusive Research, Development, License and
Manufacturing and Supply Agreement dated September 26, 2005 (the Agreement); and
WHEREAS, the Parties desire to amend the Agreement;
NOW, THEREFORE, the Parties agree as follows:
Amendment of the Agreement
The Parties hereby agree to amend the Agreement as of the Effective Date of the Amendment as
provided below. Capitalized terms used in this Amendment that are not otherwise defined herein
shall have the meanings provided in the Agreement.
1. The first sentence of Section 3.1 of the Agreement is hereby amended and restated in its
entirety to read as follows: To facilitate communication between the PARTIES, implement the
RESEARCH PLAN and oversee development of POTENTIAL PRODUCTS and COMMERCIAL PRODUCTS (all during the
TERM), the PARTIES shall appoint a JOINT STEERING COMMITTEE consisting of [***] representatives
from each of NEKTAR AL and BAXTER. The initial representatives are:
BAXTER: [***]
NEKTAR AL: [***]
and the initial meeting of the JOINT STEERING COMMITTEE shall take place no later than [***] after
the EFFECTIVE DATE.
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[***] |
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indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. |
1
2. For clarification purposes only, [***] to the Agreement is hereby amended by the addition of the
following language to the introductory paragraph thereof:
[***] defined below as [***] shall be a [***], as provided for in the [***] of this
Agreement.
2. Miscellaneous
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a. |
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Full Force and Effect. Except as expressly amended by this Amendment, the
Agreement shall remain unchanged and continue in full force and effect as provided
therein. |
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b. |
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Entire Agreement of the Parties. This Amendment and the Agreement constitute
the complete final and exclusive understanding and agreement of the Parties with
respect to the subject matter of the Agreement, and supersede any and all prior or
contemporaneous negotiations, correspondence, understandings and agreements, whether
oral or written, between the Parties respecting the subject matter of the Agreement. |
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c. |
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Counterparts. This Amendment may be executed in two or more counterparts, each
of which shall be deemed an original, but all of which together shall constitute one
and the same instrument. |
IN WITNESS WHEREOF, the Parties hereto have executed this Amendment in duplicate originals by
their authorized officers as of the Effective Date of the Amendment.
ACCEPTED AND AGREED,
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NEKTAR THERAPEUTICS AL, CORPORATION
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BAXTER HEALTHCARE CORPORATION |
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By: [***]
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By: [***] |
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Name: [***]
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Name: [***] |
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Title: [***]
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Title: [***] |
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BAXTER HEALTHCARE SA |
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By: [***] |
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Name: [***] |
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Title: [***] |
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[***] |
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indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. |
2
AMENDMENT NO. 2 TO EXCLUSIVE RESEARCH, DEVELOPMENT, LICENSE
AND MANUFACTURING AND SUPPLY AGREEMENT
This Amendment No. 2 to Exclusive Research, Development, License and Manufacturing and Supply
Agreement (the Amendment) is made and entered into effective as of December 14, 2005 (the
Effective Date of the Amendment), by and between Nektar Therapeutics AL, Corp., an Alabama
corporation (NEKTAR) and Baxter Healthcare SA and Baxter Healthcare Corp., (collectively,
BAXTER). NEKTAR and BAXTER may be referred to herein as a Party or, collectively, as Parties.
RECITALS
WHEREAS, NEKTAR and BAXTER are parties to an Exclusive Research, Development, License and
Manufacturing and Supply Agreement dated September 26, 2005, as amended (the Agreement); and
WHEREAS, the Parties desire to further amend the Agreement;
NOW, THEREFORE, for good and valuable consideration, the sufficiency and receipt of which is
hereby acknowledged, the Parties agree as follows:
Amendment of the Agreement
The Parties hereby agree to amend the Agreement as of the Effective Date of the Amendment as
provided below. Capitalized terms used in this Amendment that are not otherwise defined herein
shall have the meanings provided in the Agreement.
1. |
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A new Section 2.8 is hereby added to the Agreement as follows: |
The PARTIES have agreed to amend the RESEARCH PLAN attached to the Agreement as Schedule 1, [***]
(the Amended Research Plan). As more fully described in the Amended Research Plan, the RESEARCH
COMMITTEE is expanding the RESEARCH PLAN [***]. [***] have been approved [***] and will provide
[***] without affecting the RESEARCH PLAN that has already been agreed to by the Parties and
attached to the Agreement as Schedule 1, [***], as set forth hereinbelow, solely for the purpose
[***] shall, for purposes of this Amendment, be referred to as the [***].
Prior to initiating the [***], BAXTER will evaluate the [***]. As already provided for in the
RESEARCH PLAN that has already been agreed to by the Parties and attached to the Agreement
as Schedule 1, [***], will also proceed with [***]. If agreed by the RESEARCH COMMITTEE, [***].
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[***] |
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indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. |
3
Pursuant to the Amended Research Plan, (i) NEKTAR has agreed to and shall [***]; (ii) BAXTER shall
use such [***] for the sole purpose of making a [***]; and (iii) BAXTER shall use such [***] for
the sole purpose of conducting [***] as provided for in the Amended Research Plan. In view of the
foregoing, it is further agreed that:
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(a) |
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[***] under the Agreement; |
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(b) |
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[***] of the Agreement; and |
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(c) |
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[***] as of the EFFECTIVE DATE of the Agreement. |
In addition to the foregoing, it is understood and agreed that [***] as provided for in the Amended
Research Plan.
BAXTER further agrees to disclose in writing to NEKTAR all INVENTIONS arising from its activities
under the Amended Research Plan (including those activities relating to manufacture and/or use of
the [***]) as required by and pursuant to Section 16.2 of the Agreement. Moreover, through the
RESEARCH COMMITTEE, BAXTER shall share with NEKTAR data relating to such activities under the
Amended Research Plan as required by and pursuant to Section 3.2 of the Agreement.
It is understood and agreed that other than as specifically provided for in the Agreement, and
herein and in the Amended Research Plan, [***], and carried out under and in accordance with the
RESEARCH PLAN and the Agreement.
Notwithstanding anything herein to the contrary, [***] pursuant to the Agreement.
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a. |
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Full Force and Effect. Except as expressly amended by this Amendment, the
Agreement shall remain unchanged and continue in full force and effect as provided
therein. |
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b. |
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Entire Agreement of the Parties. This Amendment and the Agreement constitute
the complete final and exclusive understanding and agreement of the Parties with
respect to the subject matter of the Agreement, and supersede any and all prior or
contemporaneous negotiations, correspondence, understandings and agreements, whether
oral or written, between the Parties respecting the subject matter of the Agreement. |
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c. |
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Counterparts. This Amendment may be executed in two or more counterparts, each
of which shall be deemed an original, but all of which together shall constitute one
and the same instrument. |
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[***] |
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indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. |
4
IN WITNESS WHEREOF, the parties hereto have executed this Amendment in duplicate originals by
their authorized officers as of the Effective Date of the Amendment.
ACCEPTED AND AGREED,
NEKTAR THERAPEUTICS, AL
By: [***]
Name: [***]
Title: [***]
BAXTER HEALTHCARE CORPORATION
By: [***]
Name: [***]
Title: [***]
BAXTER HEALTHCARE SA
By: [***]
Name: [***]
Title: [***]
By: [***]
Name: [***]
Title: [***]
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[***] |
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indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. |
5
AMENDMENT NO. 3 TO EXCLUSIVE RESEARCH, DEVELOPMENT,
LICENSE AND MANUFACTURING AND SUPPLY AGREEMENT
This Amendment No. 3 to Exclusive Research, Development, License and Manufacturing and Supply
Agreement (the Amendment) is made and entered into effective as of December 17, 2007 (the
Effective Date of the Amendment), by and between Nektar Therapeutics AL, Corp., an Alabama
corporation (Nektar AL) and Baxter Healthcare SA and Baxter Healthcare Corp., (collectively,
Baxter). NEKTAR and BAXTER may be referred to herein as a Party or, collectively, as Parties.
RECITALS
WHEREAS, NEKTAR AL and BAXTER are parties to an Exclusive Research, Development, License and
Manufacturing and Supply Agreement dated September 26, 2005, as amended (the Agreement); and
WHEREAS, the Parties desire to further amend the Agreement;
NOW, THEREFORE, in consideration of the foregoing and the covenants and promises contained in
this Amendment and in accordance with and subject to the terms and conditions specified below the
Parties agree as follows:
Amendment of the Agreement
The Parties hereby agree to amend the Agreement as of the Effective Date of the Amendment as
provided below. Capitalized terms used in this Amendment that are not otherwise defined herein
shall have the meanings provided in the Agreement.
Any references to [***] up to but not including the sentence that begins with the words
[***], shall (as applicable) include the [***].
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[***] |
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indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. |
6
All references to the Agreement contained in any Section or subsection of the Agreement
shall mean the Agreement (as amended).
Section 1.26 is hereby deleted in its entirety and replaced by the following:
FIELD means [***], either for use alone for the treatment of [***], in the treatment of
[***]; PEGYLATED FACTOR VIII for the treatment of Hemophilia A; [***] for the treatment of
[***] and/or [***]; and/or PEGYLATED FACTOR IX for the treatment of Hemophilia B.
Section 1.46 is hereby deleted in its entirety and replaced by the following:
NEKTAR AL KNOW-HOW means all [***].
Section 1.54 is hereby deleted in its entirety and replaced by the following:
NON-DISCLOSURE AGREEMENTS means that agreement entered into between the PARTIES on [***],
providing for confidential treatment of the PARTIES information, and those agreements entered into
between the PARTIES on [***], providing for confidential treatment of the PARTES information.
Section 1.62 is hereby deleted in its entirety and replaced by the following:
POTENTIAL PRODUCT means [***] FACTOR VIII or FACTOR IX, [***] FACTOR VIII or FACTOR IX,
[***].
A new Section 1.68.A. is hereby added as follows:
PEG-FIX RESEARCH PLAN means the PARTIES respective activities and responsibilities as set
forth in the research plan attached hereto as Schedule I-A, as amended and revised by the RESEARCH
COMMITTEE from time to time.
The first sentence of Section 1.70 is hereby amended as follows:
ROYALTY RATE for COMMERCIAL PRODUCTS [***] means the following:
(i) [***] of all COMMERCIAL PRODUCTS sold in the TERRITORY in a calendar year;
(ii) [***] of all COMMERCIAL PRODUCTS sold in the TERRITORY in such calendar year; and
(iii) [***] of all COMMERCIAL PRODUCTS sold in the TERRITORY in such calendar year [***].
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[***] |
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indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. |
7
Section 1.80 is hereby deleted in its entirety and replaced by the following:
THERAPEUTIC AGENT means [***],FACTOR VIII OR FACTOR IX [***].
Section 1.82 is hereby deleted in its entirety and replaced by the following:
VALID PATENT CLAIM means [***].
A new Section 1.84 is hereby added as follows:
FACTOR IX means a compound that is a Factor IX [***].
A new Section 1.85 is hereby added as follows:
ROYALTY RATE for COMMERCIAL PRODUCTS [***], means the following:
(i) [***] of the [***] of all COMMERCIAL PRODUCTS sold in the TERRITORY in such calendar year;
(ii) [***] of the [***] of all COMMERCIAL PRODUCTS sold in the TERRITORY in such calendar year; and
(iii) [***] of all COMMERCIAL PRODUCTS sold in the TERRITORY in such calendar year [***].
Section 2.1 is hereby deleted in its entirety and replaced by the following:
OVERVIEW. The PARTIES research and development responsibilities are set forth in the
RESEARCH PLAN and/or the PEG-FIX RESEARCH PLAN (as applicable) each of which shall be an evolving
document that is updated and revised from time to time in writing by the RESEARCH COMMITTEE.
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[***] |
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indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. |
8
As decided by the RESEARCH COMMITTEE provided for in Section 3.2, and provided that [***]
(with respect to the PEG-FIX RESEARCH PLAN) each in a timely manner in accordance with the time
frames set forth in the RESEARCH PLAN or the PEG-FIX RESEARCH PLAN (as applicable) as provided for
herein, NEKTAR AL shall, in a timely manner in accordance with the time frames set forth in the
RESEARCH PLAN or the PEG-FIX RESEARCH PLAN (as applicable), [***]. BAXTER shall, in a timely manner
in accordance with the time frames set forth in the RESEARCH PLAN and the PEG-FIX RESEARCH PLAN (as
applicable), provide NEKTAR AL with [***].
NEKTAR AL shall use commercially reasonable efforts to collaborate and cooperate with BAXTER
in researching and developing CONJUGATES and REAGENTS (including SELECTED REAGENTS) to be utilized
in developing POTENTIAL PRODUCTS pursuant to the RESEARCH PLAN and the PEG-FIX RESEARCH PLAN, as
each may be amended from time to time. Initially, [***]. After the RESEARCH COMMITTEE selects one
or more CONJUGATES to develop into POTENTIAL PRODUCTS, the REAGENT that is used to make each such
CONJUGATE shall be deemed a SELECTED REAGENT hereunder, and [***], as set forth in [***] below.
BAXTER is responsible for the development of POTENTIAL PRODUCTS after receipt of the
CONJUGATES and SELECTED REAGENTS, in accordance with the RESEARCH PLAN and/or the PEG-FIX RESEARCH
PLAN (as applicable), and [***].
For clarity, [***]. During such clinical trials, or in the event of the cancellation or
failure of any such clinical trials, [***].
A new Section 2.2.1 is hereby added as follows:
NEKTAR AL PAYMENTS. For clarity, Section 2.2 shall apply only with respect to NEKTAR
ALS activities in relation to [***] PEGYLATED FACTOR VIII [***] and this Section 2.2.1 shall apply
only with respect to NEKTAR ALS activities in relation to PEGYLATED FACTOR IX. Accordingly, in
addition to the MILESTONES and royalties to be paid by BAXTER to NEKTAR AL under the AGREEMENT,
BAXTER shall reimburse NEKTAR AL for those activities directly incurred and solely associated with
the research, development and/or manufacture of CONJUGATES and REAGENTS (including SELECTED
REAGENTS) for PEGYLATED FACTOR IX at the applicable FTE rate as described in the immediately
following paragraph.
The applicable FTE rate (which includes time, standard supplies and material) shall be charged
and invoiced at [***] for each FTE per year (PEG-FIX FTE RATE), subject to the following
increases: the PEG-FIX FTE RATE shall be adjusted each calendar year commencing with calendar year
2009 to reflect any year-to-year increase in the Consumer Price Index (CPI)
(based on a cumulative index of CPI numbers starting on the Effective Date of the Amendment to
the date of the calculation of such PEG-FIX FTE RATE). Moreover, for purposes of work performed by
NEKTAR AL in relation to PEGYLATED FACTOR IX, one (1) FTE will equal [***].
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[***] |
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indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. |
9
In addition to the foregoing, BAXTER shall reimburse NEKTAR AL for additional materials
purchased by NEKTAR AL to perform its activities under the PEG-FIX RESEARCH PLAN, [***], which
materials shall be equipment purchased by NEKTAR AL that is required for the performance of its
activities under the PEG-FIX RESEARCH PLAN. The cost of such materials shall not exceed [***].
BAXTER shall respond to such a request by NEKTAR AL promptly, and in no event later than [***]
after its receipt of such request.
NEKTAR AL shall invoice FTE costs (which includes time at the PEG-FIX FTE RATE, standard
supplies and material) and costs of additional materials to BAXTER [***], which BAXTER may audit,
pursuant to Section 10.2 of the AGREEMENT. For clarity, BAXTER shall pay for [***], which shall be
calculated by multiplying (i) [***] pursuant to this Amendment by (ii) the quotient of (a) the
PEG-FIX FTE RATE divided by (b) [***]. BAXTER shall pay the amounts set forth in each such invoice
within [***] after the date thereof.
For clarity, BAXTER shall pay NEKTAR AL as provided for under this Section 2.2.1 for so long
as NEKTAR AL is performing activities under the PEG-FIX RESEARCH PLAN; provided, however, that on a
POTENTIAL PRODUCT-by-POTENTIAL PRODUCT basis, such [***], at which point the [***] and, thereafter,
the [***] used in such POTENTIAL PRODUCT [***] of the AGREEMENT and the SUPPLY AGREEMENT.
For the avoidance of doubt, the PARTIES acknowledge that the [***] that is required to be paid
by BAXTER to NEKTAR AL within [***], as set forth on Schedule II-A, is an [***] by BAXTER of the
FTE costs (which includes time at the PEG-FIX FTE RATE, standard supplies and material) to be paid
by BAXTER pursuant to this Section 2.2.1. Notwithstanding the foregoing, NEKTAR AL shall provide an
invoice to BAXTER as required above which invoice shall set forth a calculation of the FTE costs
totaling [***] and a corresponding credit for the [***]; provided, however, that such calculation
shall only include a total [***].
The first sentence of Section 2.4.2 is hereby deleted in its entirety and shall be
replaced by the following:
Any samples of [***] (collectively, the BAXTER MATERIALS) are owned exclusively by BAXTER
and provided solely for the development of CONJUGATES and REAGENTS to extend the half-life of a
particular THERAPEUTIC AGENT in conjunction with the RESEARCH PLAN or the PEG-FIX RESEARCH PLAN (as
applicable), and for no other purpose.
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[***] |
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indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. |
10
A new Section 2.6.1 is hereby added as follows:
SELECTION OF PEGYLATED FACTOR IX POTENTIAL PRODUCTS AND [***]. The RESEARCH COMMITTEE
shall select PEGYLATED FACTOR IX POTENTIAL PRODUCT(S) from the CONJUGATES and SELECTED REAGENTS
provided by NEKTAR AL under the PEG-FIX RESEARCH PLAN and, [***].
The first paragraph of Section 3.2 is hereby deleted in its entirety and replaced by the
following:
RESEARCH COMMITTEE. The RESEARCH COMMITTEE shall be comprised of appropriate
representatives of both PARTIES, initially consisting of [***] representatives from each of NEKTAR
AL and BAXTER. Each PARTY shall appoint a RESEARCH PLAN team leader (and other key contacts, as
necessary) to serve as principal RESEARCH COMMITTEE liaisons for the PARTIES. Employees of each
PARTY who are not on the RESEARCH COMMITTEE may attend meetings of the RESEARCH COMMITTEE, as
required to further the research and development of POTENTIAL PRODUCTS and COMMERCIAL PRODUCTS. The
initial team leader and PARTY representatives are:
BAXTER: (1) [***]
NEKTAR AL: (1) [***].
A new Section 3.6 is hereby added as follows:
3.6.1 [***].
3.6.2 Disbanding of Committees. [***], the PARTIES shall have the right to disband any
committee upon mutual agreement. Additionally, to the extent the applicable committee is not
disbanded, such committees shall be automatically disbanded, as applicable, as set forth below:
(i) The JOINT STEERING COMMITTEE shall be automatically disbanded upon [***].
(ii) The DEVELOPMENT AND PRODUCTION COMMITTEE shall be automatically disbanded when [***].
(iii) The RESEARCH COMMITTEE shall be automatically disbanded upon [***].
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[***] |
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indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. |
11
3.6.3 Decision Making After [***] or Disbanding of Committees. If [***], or if a
committee is disbanded pursuant to Section 3.6.2, then after such [***] disbanding, the following
shall apply to decisions formerly within the jurisdiction of the committee(s) [***] or that has
been disbanded:
(a) Decisions formerly within the jurisdiction of the JOINT STEERING COMMITTEE shall be
submitted for resolution by senior officers of each PARTY, subject to the decision making processes
and principles set forth in Section 3.1 applied to decisions to be made by such senior officers
rather than to decisions to be made by the JOINT STEERING COMMITTEE.
(b) Decisions formerly within the jurisdiction of the DEVELOPMENT AND PRODUCTION COMMITTEE
shall be submitted for resolution by the JOINT STEERING COMMITTEE, if it then exists, or otherwise
by senior officers appointed by each PARTY as described in Section 3.6.3(a).
(c) Decisions formerly within the jurisdiction of the RESEARCH COMMITTEE shall be submitted
for resolution by the JOINT STEERING COMMITTEE, if it then exists, or otherwise by senior officers
appointed by each PARTY as described in Section 3.6.3(a).
Notwithstanding the amendments to the decision making structure as set forth in this Section
3.6.3, with respect to all decisions that would have been within the jurisdiction of the Research
Committee BAXTER shall retain the deciding vote pursuant to Section 3.2 of the Agreement.
Section 4.2 is hereby amended by deleting the first paragraph through subsection (iii) and
replacing it with the following:
TERMS OF SUBLICENSE. The terms of each sublicense under the license granted to BAXTER in
Section 4.1 of this AGREEMENT shall provide that any sublicense shall be subject to and consistent
with the terms and conditions of this AGREEMENT; provided, however, that:
(i) all royalties or other amounts due to NEKTAR AL with respect to such SUBLICENSEES development
and/or commercialization of POTENTIAL PRODUCTS or
COMMERCIAL PRODUCTS shall be collected by BAXTER and transmitted to NEKTAR AL in accordance with
the payment terms set forth in Article 9.
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[***] |
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indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. |
12
(ii) BAXTERS grant of any sublicense shall not relieve BAXTER from any of its obligations under
this AGREEMENT; and
(iii) BAXTER shall remain jointly and severally liable for any breach of a sublicense by a
SUBLICENSEE.
Section 4.3 is hereby amended by deleting subsection (iii) of the first paragraph and deleting
the second and third full paragraphs.
A new Section 7.2.1 is hereby added as follows:
For clarity, Section 7.2 shall apply with respect to the activities of BAXTER, its AFFILIATES
or SUBLICENSEES in relation to the development, manufacture or commercialization of POTENTIAL
PRODUCTS and/or COMMERCIAL PRODUCTS utilizing (directly or indirectly) [***]. For good and valuable
consideration (the receipt and sufficiency of which is hereby acknowledged by BAXTER), with respect
to the activities of BAXTER, its AFFILIATES and SUBLICENSEES in relation to the development,
manufacture or commercialization of [***], BAXTER agrees to partner exclusively with NEKTAR AL in
the FIELD. Specifically, during the TERM, [***] other than as provided for in this Amendment or
[***], anywhere in the TERRITORY. [***].
Nothing set forth in this Section 7.2.1 shall prohibit BAXTER from owning not in excess of 5%
in the aggregate of any class of capital stock of any corporation if such stock is publicly traded
and listed on any national or regional stock exchange or on the NASDAQ national market system or
the NASDAQ Small Cap Market.
In the event that the provisions of Sections 7.1, 7.2 or 7.2.1 should ever be deemed to exceed
the limitation provided by applicable law, then the PARTIES agree that such provisions shall be
reformed to set forth the maximum limitations permitted.
Section 8.6.1 is hereby amended as follows:
From the date of selection of a SELECTED REAGENT until the earlier of the date of
commencement of a PIVOTAL TRIAL or the date on which the PARTIES enter into the SUPPLY AGREEMENT
for such SELECTED REAGENT, BAXTER shall pay NEKTAR AL its MANUFACTURING COST [***] for each
SELECTED REAGENT supplied to BAXTER [***] (PURCHASE PRICE). BAXTER shall be entitled to audit
such MANUFACTURING COST pursuant to Section 10.2.
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[***] |
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indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. |
13
The first paragraph of Section 9.1 (up to but excluding subsection (i)) is hereby deleted in its entirety and is replaced with the following:
BAXTER shall pay to NEKTAR AL MILESTONES in accordance with and pursuant to the events
described in Schedule II (with respect to POTENTIAL PRODUCT and/or COMMERCIAL PRODUCT ([***]) and
in Schedule II-A (with respect to [***], each as the case may be. Each such applicable MILESTONE
shall be payable at the time the corresponding event occurs, and due within [***] of the event
triggering such MILESTONE. Except as set forth in the last paragraph of Section 2.2.1, MILESTONE
payments shall not be advance payments against any royalties or other payments due and payable
hereunder, but shall be in addition to any royalty or other payments due under the AGREEMENT and
this Amendment. In the event BAXTER [***].
A new Section 9.1.5 is hereby added as follows:
[***] MILESTONES FOR THE DEVELOPMENT AND COMMERCIALIZATION OF ONE COMMERCIAL PRODUCT FOR
THE TREATMENT OF HEMOPHILIA B. The MILESTONES that are provided for under Schedule II-A shall
apply with respect to the first POTENTIAL PRODUCT being developed for Hemophilia B using FACTOR IX
as the THERAPEUTIC AGENT that achieves each such MILESTONE, and the first COMMERCIAL PRODUCT
receiving MARKETING AUTHORIZATION having a label indication for the treatment of Hemophilia B using
FACTOR IX as the THERAPEUTIC AGENT. Such POTENTIAL PRODUCT and COMMERCIAL PRODUCT for the treatment
of Hemophilia B using FACTOR IX as the THERAPEUTIC AGENT may be the same, but in the event they are
not, [***]. For clarity, additional milestone payments may be payable by BAXTER in accordance with
the provisions of Section 9.1.6.
For clarity, BAXTER or its AFFILIATE or SUBLICENSEE, at BAXTERS discretion, shall be [***].
NEKTAR AL shall not be entitled to additional MILESTONES for additional label claims that are
obtained by BAXTER or its AFFILIATE or SUBLICENSEE for then-existing COMMERCIAL PRODUCTS for the
treatment of Hemophilia B using FACTOR IX as the THERAPEUTIC AGENT. [***].
For the avoidance of doubt, NEKTAR AL shall not be entitled to the payment of any MILESTONES
with respect to any POTENTIAL PRODUCT or COMMERCIAL PRODUCT developed for [***] as the THERAPEUTIC
AGENT, unless those milestones to be negotiated under Section 9.1.2 have not yet been paid when the
MILESTONE events occur with [***].
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[***] |
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indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. |
14
A new Section 9.1.6 is hereby added as follows:
ADDITIONAL MILESTONES FOR THE COMMERCIALIZATION OF MORE THAN ONE COMMERCIAL PRODUCT FOR
THE TREATMENT OF HEMOPHILIA B. After the receipt of MARKETING AUTHORIZATION for the first
FACTOR IX COMMERCIAL PRODUCT for the treatment of Hemophilia B (using FACTOR IX as the THERAPEUTIC
AGENT), NEKTAR AL shall be entitled to receive milestone payments in addition to the MILESTONES
provided for in Schedule II-A, for each additional POTENTIAL PRODUCT with a label indication for
the treatment of Hemophilia B using FACTOR IX as the THERAPEUTIC AGENT, for which BAXTER or its
AFFILIATE or SUBLICENSEE receives a new MARKETING AUTHORIZATION in the United States and/or
European Union. With respect to any additional POTENTIAL PRODUCTS that are FACTOR IX half-life
extension products, additional milestone payments shall be made upon the successful completion of a
PIVOTAL TRIAL in adults for each such additional POTENTIAL PRODUCT and for each MARKETING
AUTHORIZATION received in the United States and/or European Union for each such additional
POTENTIAL PRODUCT. [***] for each such additional POTENTIAL PRODUCT, provided that the [***] for
each such additional POTENTIAL PRODUCT [***] per POTENTIAL PRODUCT.
[***].
For the avoidance of doubt, a modified COMMERCIAL PRODUCT (including, but not limited to,
modified with respect to formulation, presentation, packaging or dosage strength) shall not be
considered an additional COMMERCIAL PRODUCT and NEKTAR AL shall not be entitled to any additional
milestone payments pursuant to Section 9.1.2 or pursuant to Section 9.1.6 upon the
commercialization of any such modified COMMERCIAL PRODUCT if such
COMMERCIAL PRODUCT uses the same THERAPEUTIC AGENT and SELECTED REAGENT as the unmodified
COMMERCIAL PRODUCT.
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[***] |
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indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. |
15
The first paragraph of Section 9.2 (up to but excluding Section 9.2.1) is hereby
deleted in its entirety and replaced with the following:
ROYALTIES. With respect to COMMERCIAL PRODUCTS that either (a) contain a chemical
entity resulting from attachment of [***] to a SELECTED REAGENT by means of PEGYLATION that is
selected by the RESEARCH COMMITTEE, or (ii) use PEGYLATION to [***], whether by using PEGYLATION
technology [***], BAXTER shall pay NEKTAR AL royalties in an amount equal to the product of the
applicable ROYALTY RATE and the annual aggregate NET SALES of all such COMMERCIAL PRODUCTS on a
COMMERCIAL PRODUCT-by-COMMERCIAL PRODUCT and country-by-country basis for an initial period of
[***] from the FIRST COMMERCIAL SALE of the applicable COMMERCIAL PRODUCT in the applicable country
(the INITIAL ROYALTY TERM). Royalties shall be paid during the INITIAL ROYALTY TERM in each and
every country where such COMMERCIAL PRODUCT is sold, without regard to whether a VALID PATENT CLAIM
covers the composition, manufacture, use, sale, offer for sale or import of the COMMERCIAL PRODUCT
or the SELECTED REAGENT contained in such COMMERCIAL PRODUCT.
With respect to COMMERCIAL PRODUCTS that either (a) contain a chemical entity resulting from
attachment of FACTOR IX to a SELECTED REAGENT by means of PEGYLATION that is selected by the
RESEARCH COMMITTEE, or (b) use PEGYLATION to extend or otherwise improve the half-life of FACTOR
IX, BAXTER shall pay NEKTAR AL royalties in an amount equal to the product of the applicable
ROYALTY RATE and the annual aggregate NET SALES of all such COMMERCIAL PRODUCTS on a COMMERCIAL
PRODUCT-by-COMMERCIAL PRODUCT and country-by-country basis for an initial period of [***] from the
FIRST COMMERCIAL SALE of the applicable COMMERCIAL PRODUCT in the applicable country (the PEG-FIX
INITIAL ROYALTY TERM). Royalties shall be paid during the PEG-FIX INITIAL ROYALTY TERM in each and
every country where such COMMERCIAL PRODUCT is sold, without regard to whether a VALID PATENT CLAIM
covers the composition, manufacture, use, sale, offer for sale or import of the COMMERCIAL PRODUCT
or the SELECTED REAGENT contained in such COMMERCIAL PRODUCT.
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[***] |
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indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. |
16
Section 9.2.1 is hereby deleted in its entirety and replaced by the following:
After the expiration of the INITIAL ROYALTY TERM or PEG-FIX INITIAL ROYALTY TERM, as the case
may be, for a particular COMMERCIAL PRODUCT in a particular country, BAXTER shall continue to pay
such royalties on NET SALES of such COMMERCIAL PRODUCT on a world-wide basis provided that there
exists, in each of the
following major markets in which MARKETING AUTHORIZATION is received for such COMMERCIAL
PRODUCT, a VALID PATENT CLAIM which would be infringed by the composition, making, using, having
made, offering for sale, sale or importation of such COMMERCIAL PRODUCT or the SELECTED REAGENT
contained in such COMMERCIAL PRODUCT: [***] (collectively, MAJOR MARKETS). Such royalties shall
be paid on NET SALES of COMMERCIAL PRODUCTS in those countries where the composition, manufacture,
import, use, offer for sale or sale of the applicable COMMERCIAL PRODUCT or the SELECTED REAGENT
contained in such COMMERCIAL PRODUCT is not covered by a VALID PATENT CLAIM, provided that the
composition, manufacture, import, use, offer for sale or sale of such applicable COMMERCIAL PRODUCT
or such SELECTED REAGENT is covered by a VALID PATENT CLAIM in each of the MAJOR MARKETS. [***].
Section 9.2.2 is hereby deleted in its entirety and replaced by the following:
If, at the time of sale of a COMMERCIAL PRODUCT in a particular country after the expiration
of the INITIAL ROYALTY TERM or PEG-FIX INITIAL ROYALTY TERM, as the case may be, in such country,
there is no VALID PATENT CLAIM covering the composition, manufacture, use, import, offer for sale
or sale of such COMMERCIAL PRODUCT or the SELECTED REAGENT contained in such COMMERCIAL PRODUCT in
each of the MAJOR MARKETS, then BAXTER shall only owe royalties with respect to NET SALES of
COMMERCIAL PRODUCTS in those countries in which a VALID PATENT CLAIM covers the composition,
manufacture, use, import, offer for sale or sale of such COMMERCIAL PRODUCTS or the SELECTED
REAGENT contained in such COMMERCIAL PRODUCTS in such countries. [***].
Section 9.2.3 is hereby deleted in its entirety and replaced by the following:
The PARTIES agree that a VALID PATENT CLAIM exists, for purposes of determining whether
royalties are payable after the expiration of the INITIAL ROYALTY TERM or PEG-FIX INITIAL ROYALTY
TERM, as the case may be, even if components of a COMMERCIAL PRODUCT are sold separately as more
fully described in Section 9.3 below, and the only VALID PATENT CLAIM covers the composition,
manufacture, use, sale, offer for sale or import of only one component of such COMMERCIAL PRODUCT
([***]).
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[***] |
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indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. |
17
Section 9.4 is hereby deleted in its entirety and replaced by the following:
COMMERCIAL DILIGENCE FOR COMMERCIAL PRODUCTS FOR THE TREATMENT OF HEMOPHILIA A. If,
during the TERM, BAXTER sells or markets another FACTOR VIII extended half-life product using a
non-PEGYLATION technology which is used to treat Hemophilia A, then BAXTER must meet the COMMERCIAL
DILIGENCE THRESHOLD, as set forth below. No later than [***] after the FIRST COMMERCIAL SALE
of a COMMERCIAL PRODUCT for the treatment of Hemophilia A, where [***] is the THERAPEUTIC
AGENT, in each MAJOR MARKET in which MARKETING AUTHORIZATION has been obtained, the sales ([***])
of all such COMMERCIAL PRODUCTS in the aggregate shall constitute [***] of the total sales ([***])
of all FACTOR VIII extended half-life products used to treat Hemophilia A in such MAJOR MARKET (the
COMMERCIAL DILIGENCE THRESHOLD). If sales ([***]) of such COMMERCIAL PRODUCTS, in the aggregate,
do not meet the COMMERCIAL DILIGENCE THRESHOLD in such MAJOR MARKET within such timeframe, then
NEKTAR AL may, [***], upon written notice to BAXTER, [***]. In the event NEKTAR AL [***], the
ROYALTY RATE to which NEKTAR AL is otherwise entitled shall be [***] for all NET SALES of all
COMMERCIAL PRODUCTS [***]. The terms of any such co-promotion agreement shall be negotiated in good
faith by the PARTIES, and shall include minimum co-promotion requirements and shall provide that
[***].
A new Section 9.4.1 is hereby added as follows:
COMMERCIAL DILIGENCE FOR COMMERICAL PRODUCTS FOR THE TREATMENT OF HEMOPHILIA B. If,
during the TERM, BAXTER sells or markets another FACTOR IX extended half-life product using a
non-PEGYLATION technology which is used to treat Hemophilia B, then BAXTER must meet the COMMERCIAL
DILIGENCE THRESHOLD, as set forth below. No later than [***] after the FIRST COMMERCIAL SALE of a
COMMERCIAL PRODUCT for the treatment of Hemophilia B using FACTOR IX as the THERAPEUTIC AGENT, in
each MAJOR MARKET in which MARKETING AUTHORIZATION has been obtained, the sales ([***]) of all such
COMMERCIAL PRODUCTS in the aggregate shall constitute [***] of the total sales ([***]) of all
FACTOR IX extended half-life products used to treat Hemophilia B in such MAJOR MARKET (the
COMMERCIAL DILIGENCE THRESHOLD). If sales ([***]) of such COMMERCIAL PRODUCTS, in the aggregate,
do not meet the COMMERCIAL DILIGENCE THRESHOLD in such MAJOR MARKET within such timeframe, then
NEKTAR AL may, [***], upon written notice to BAXTER, [***]. In the event NEKTAR AL [***] such
FACTOR IX COMMERCIAL PRODUCTS, the ROYALTY RATE to which NEKTAR AL is otherwise entitled shall be
[***] for all NET SALES of all COMMERCIAL PRODUCTS [***]. The terms of any such co-promotion
agreement shall be negotiated in good faith by the PARTIES, and shall include minimum co-promotion
requirements and shall provide that [***].
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[***] |
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indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. |
18
A new Section 9.4.2 is hereby added as follows:
COMMERCIAL DILIGENCE FOR COMMERICIAL PRODUCTS FOR THE TREATMENT OF HEMOPHILIA A AND/OR
B. If, during the TERM, BAXTER sells or markets another [***] extended half-life product [***]
which is used to treat Hemophilia A
and/or Hemophilia B, then BAXTER must meet the COMMERCIAL DILIGENCE THRESHOLD, as set forth
below. No later than [***] after the FIRST COMMERCIAL SALE of a COMMERCIAL PRODUCT for the
treatment of Hemophilia A or Hemophilia B using [***] as the THERAPEUTIC AGENT, in each MAJOR
MARKET in which MARKETING AUTHORIZATION has been obtained, the sales ([***]) of all such COMMERCIAL
PRODUCTS in the aggregate shall constitute [***] of the total sales ([***]) of all [***] extended
half-life products used to treat Hemophilia A and/or Hemophilia B in such MAJOR MARKET (the
COMMERCIAL DILIGENCE THRESHOLD). If sales ([***]) of such COMMERCIAL PRODUCTS, in the aggregate,
do not meet the COMMERCIAL DILIGENCE THRESHOLD in such MAJOR MARKET within such timeframe, then
NEKTAR AL may, [***], upon written notice to BAXTER, [***] COMMERCIAL PRODUCTS in such MAJOR
MARKET. In the event NEKTAR AL [***] COMMERCIAL PRODUCTS, the ROYALTY RATE to which NEKTAR AL is
otherwise entitled shall be [***] for all NET SALES of all COMMERCIAL PRODUCTS [***]. The terms of
any such co-promotion agreement shall be negotiated in good faith by the PARTIES, and shall include
minimum co-promotion requirements and shall provide that [***].
A new Section 9.7 is hereby added as follows:
OPTION TO ACQUIRE ADDITONAL LICENSE. In addition to the license granted by NEKTAR AL to
BAXTER under Section 4.1, BAXTER may wish to exercise an option to enter into negotiations with
NEKTAR AL to acquire an additional license (the OPTION). The conditions under which such OPTION
may be exercised, and certain of the terms of such license, [***]. The PARTIES acknowledge and
agree that the [***].
References to NON-DISCLOSURE AGREEMENT in Article 11 are hereby made plural. Any reference to
BAXTER MATERIALS and NEKTAR AL MATERIALS in Article 11 includes BAXTER FIX MATERIALS and NEKTAR AL
PEG-FIX MATERIALS.
The first sentence of Section 17.2.2A. is hereby deleted in its entirety and replaced by the
following:
NEKTAR AL shall have the right, but not the obligation, to carry out actions against THIRD
PARTIES arising from such THIRD PARTIES infringement or misappropriation of NEKTAR AL LICENSED
TECHNOLOGY covering the composition, manufacture, use, import, offer for sale or sale of a SELECTED
REAGENT.
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[***] |
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indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. |
19
Section 19.2 is hereby deleted in its entirety and replaced by the following:
DISCRETIONARY TERMINATION. BAXTER may terminate this AGREEMENT
(i) in its entirety, other than pursuant to any other provision of this AGREEMENT, at any time,
without any liability other than payment of the TERMINATION FEES, if applicable, payable in
accordance with both Sections 19.7.5 and 19.7.6, upon [***] to NEKTAR AL;
(ii) in part, upon [***] to NEKTAR AL, with respect to the development and/or commercialization of
POTENTIAL PRODUCTS and COMMERCIAL PRODUCTS utilizing (directly or indirectly) [***], other than
pursuant to any other provision of this AGREEMENT, at any time, without any liability other than
payment of the TERMINATION FEE, if applicable, payable in accordance with Section 19.7.5; or
(iii) in part, upon [***] to NEKTAR AL, with respect to the development and/or commercialization of
POTENTIAL PRODUCTS and COMMERCIAL PRODUCTS utilizing (directly or indirectly) [***], other than
pursuant to any other provision of this AGREEMENT, at any time, without any liability other than
payment of the TERMINATION FEE, if applicable, payable in accordance with Section 19.7.6.
Section 19.3 is hereby amended by adding the following to the end of the existing
text:
Notwithstanding the foregoing, if the failure to comply relates [***], the non-breaching
party may only terminate the AGREEMENT in part with respect to all of the THERAPEUTIC AGENTS
specified in (a), or with respect to the THERAPETIC AGENT specified in (b). If the failure to
comply relates to both (c) [***], the non-breaching party [***].
The first two paragraphs of Section 19.5 are hereby deleted in their entirety and
replaced by the following:
In the event [***] (each such failure to meet and lack of extension hereinafter referred to
as a DILIGENCE DEFECT), then [***]:
(i) at its option, terminate this AGREEMENT in part with respect to [***], if the DILIGENCE DEFECT
relates to a Development Diligence milestone set forth in Schedule IV;
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[***] |
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indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. |
20
(ii) at its option, terminate this AGREEMENT in part with respect to [***], if the DILIGENCE DEFECT
relates to a Development Diligence milestone set forth in Schedule IV-A; or
(iii) at its option, terminate this AGREEMENT [***] DILIGENCE DEFECT relating to a Development
Diligence milestone set forth in Schedule IV and a DILIGENCE DEFECT relating to a Development
Diligence milestone set forth in Schedule IV-A.
In the event [***], Section 7.1 shall no longer apply with respect to that portion of the
AGREEMENT and those THERAPEUTIC AGENTS that have been so [***], but the royalties and MILESTONES
provided for herein shall continue to apply except as otherwise set forth in Section 19.5.2.
Notwithstanding the foregoing, before [***] under this Section 19.5, [***] shall call a special
meeting of the JOINT STEERING COMMITTEE for the [***]. Such special meeting of the JOINT STEERING
COMMITTEE shall be held as soon as practicable, but in no event later than [***] from the date on
which [***] requests such meeting. At any time during the period commencing on the conclusion of
such meeting up through the date that is [***] and [***] after the applicable milestone date,
[***]. Thereafter, [***] to either cure (by meeting such Development Diligence milestone event) or
to extend the milestone date by the duration of the applicable extension period set forth in
Schedule IV or Schedule IV-A (as applicable), by providing written notice of its intent to extend
and by paying the applicable extension payment within [***] thereafter. For clarity, the extension
period shall commence at the end of the [***].
Subsection G. of Section 19.5.1 is hereby deleted its entirety and replaced by the following:
G. [***].
A new Section 19.7.6 is hereby added as follows:
For clarity, Section 19.7.5 shall apply with respect to termination of the AGREEMENT by
BAXTER in its entirety pursuant to Section 19.2(i) or in part under Section 19.2(ii). If
BAXTER terminates the AGREEMENT in its entirety pursuant to Section 19.2(i) or in part under
Section 19.2(iii), or if NEKTAR AL terminates the AGREEMENT in its entirety or in part (with
respect to FACTOR IX) under Section 19.3(b), or if NEKTAR AL terminates the AGREEMENT in part
([***], then BAXTER shall pay to NEKTAR AL a termination fee (PEG-FIX TERMINATION FEE) within
[***] after the effective date of such termination as follows:
(a) If termination occurs after the [***], BAXTER shall pay NEKTAR AL a PEG-FIX TERMINATION
FEE of [***];
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indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. |
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(b) If termination occurs after the [***], BAXTER shall pay NEKTAR AL a PEG-FIX TERMINATION
FEE of [***]; and
(c) If termination occurs after the [***], BAXTER shall pay NEKTAR AL a PEG-FIX TERMINATION
FEE of [***].
If BAXTER terminates the AGREEMENT in its entirety under Section 19.2(i), BAXTER shall pay
NEKTAR AL both the TERMINATION FEE due and owing to NEKTAR AL under Section 19.7.5, and the PEG-FIX
TERMINATION FEE due and owing to NEKTAR AL under this Section 19.7.6. If NEKTAR AL terminates the
AGREEMENT in its entirety under Section 19.3, BAXTER shall pay NEKTAR AL [***]. If NEKTAR AL
terminates the AGREEMENT in part under Section 19.3(a) ([***]), BAXTER shall pay NEKTAR AL [***].
If NEKTAR AL terminates the AGREEMENT in part under Section 19.3(b) ([***]), BAXTER shall pay
NEKTAR AL [***].
Notwithstanding the foregoing, if BAXTER terminates the AGREEMENT in part under Section
19.2(iii) due to a COMMERCIAL FAILURE, the TERMINATION FEE set forth in this Section 19.7.6 [***].
COMMERCIAL FAILURE means:
(i) [***], as defined by the RESEARCH COMMITTEE;
(ii) [***];
(iii) [***];
(iv) [***];
(v) [***];
(vi) [***].
For clarity, if the AGREEMENT is terminated by BAXTER in part under Section 19.2(iii) due to a
COMMERCIAL FAILURE, there shall be [***].
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[***] |
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indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. |
22
Miscellaneous
a. Full Force and Effect. Except as expressly amended by this Amendment, the
AGREEMENT shall remain unchanged and continue in full force and effect as provided therein.
b. Entire Agreement of the Parties. This Amendment and the AGREEMENT
constitute the complete final and exclusive understanding and agreement of the PARTIES with
respect to the subject matter of the AGREEMENT, and supersede any and all prior or contemporaneous
negotiations, correspondence, understandings and agreements, whether oral or written, between the
PARTIES respecting the subject matter of the AGREEMENT.
c. Counterparts. This Amendment may be executed in two or more counterparts,
each of which shall be deemed an original, but all of which together shall constitute one and
the same instrument. One or more counterparts of this Amendment may be executed my facsimile or
other electronic means.
[Signature Page Follows]
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indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. |
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[Signature Page to Amendment No. 3]
IN WITNESS WHEREOF, the parties hereto have executed this Amendment in duplicate originals by
their authorized officers as of the Effective Date of the Amendment.
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ACCEPTED AND AGREED, |
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NEKTAR THERAPEUTICS AL, CORP. |
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BAXTER HEALTHCARE SA |
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indicates that certain information contained herein has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been requested with
respect to the omitted portions. |
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
Execution Copy
AMENDMENT NO. 4 TO EXCLUSIVE RESEARCH, DEVELOPMENT, LICENSE AND
MANUFACTURING AND SUPPLY AGREEMENT
This Amendment No. 4 to Exclusive Research, Development, License and Manufacturing and Supply
Agreement (the Amendment) is made and entered into and is effective as of 11:59 pm on December
31, 2008 (the Effective Date of Amendment No. 4), by and between Nektar Therapeutics AL, Corp., an
Alabama corporation (Nektar AL) and Baxter Healthcare SA and Baxter Healthcare Corp.,
(collectively, Baxter). NEKTAR and BAXTER may be referred to herein as a Party or,
collectively, as Parties.
RECITALS
WHEREAS, NEKTAR AL and BAXTER are parties to an Exclusive Research, Development, License and
Manufacturing and Supply Agreement dated as of September 26, 2005, and amended as of October 19,
2005, December 14, 2005, and December 17, 2007 (the Agreement); and
WHEREAS, the Parties desire to further amend the Agreement;
NOW, THEREFORE, in consideration of the foregoing and the covenants and promises contained in
this Amendment and in accordance with and subject to the terms and conditions specified below the
Parties agree as follows:
Amendment of the Agreement
The Parties hereby agree to amend the Agreement as of the Effective Date of Amendment No. 4
as provided below. Capitalized terms used in this Amendment that are not otherwise defined herein
shall have the meanings provided in the Agreement.
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1. |
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All references to the Agreement contained in any Section or subsection of the
Agreement shall mean the Agreement (as amended). |
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2. |
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New Section 1.86 is added to the Agreement, as follows: |
1.86 EXCLUSIVE LICENSE AGREEMENT shall mean that certain Exclusive License Agreement
dated as of December 31, 2008, by and among Nektar and Baxter.
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3. |
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The Parties agree to add a new Section 2.2.2 to the Agreement, as follows; |
[***]. BAXTER agrees that as of [***], BAXTER shall have expended an
aggregate amount of at least [***] in actual cash payments to NEKTAR AL for research
and development costs directly incurred and solely associated with the development of
[***]. BAXTERs obligation to pay any remaining unpaid portion of the [***] shall
terminate in the event of [***].
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
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The Parties agree to amend Section 36 of Amendment No. 3 of the Agreement, amending
Section 19.2(ii) of the Agreement by deleting the present Section 19.2(ii) in its entirety
and replacing it with the following: |
(ii) Subject to the limitation on termination in part of this AGREEMENT by BAXTER set
forth in Section 19.2(iv), upon [***] to NEKTAR AL, with respect to the development
and/or commercialization of POTENTIAL PRODUCTS and COMMERCIAL PRODUCTS utilizing
(directly or indirectly) [***], other than pursuant to any other provision of this
AGREEMENT, which termination may be effected in whole or in part for any one or more of
[***], at any time, without any liability other than payment of the [***], if
applicable, payable in accordance with Section 19.7.5 (which [***] otherwise due and
payable to NEKTER AL in the event of a termination effected in whole shall be prorated
in the case of a termination in part on the following basis: [***];
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The Parties agree to amend Section 36 of Amendment No. 3 of the Agreement to add the
following Subsection (iv) to Section 19.2 of the Agreement: |
Notwithstanding anything in this AGREEMENT seemingly to the contrary, BAXTER agrees
that it will not terminate this AGREEMENT in whole or in part pursuant to Section 19.2
prior to [***], except for [***].
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The Parties agree to add a new Section 23 to the Agreement, as follows: |
23. ALTERNATIVE DISPUTE RESOLUTION.
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Mediation. The PARTIES agree that any and all disputes, claims or
controversies arising out of or relating to this AGREEMENT shall be submitted to [***]
for mediation, and if the matter is not resolved through mediation, then it shall be
submitted to [***] for final and binding arbitration pursuant to the arbitration clause
set forth in Section 23(b) below; provided, however, that either PARTY may apply to any
court of appropriate jurisdiction to seek equitable relief without the requirement of
pursuing arbitration pursuant to Section 23(b).
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The PARTIES shall attempt to resolve any and all disputes, claims or
controversies arising out of or relating to this AGREEMENT promptly by
negotiation between executives who have authority to settle the controversy.
If such disputes, claims or controversies are not resolved through such
negotiation, then they shall be submitted for final and binding arbitration
pursuant to the arbitration clause set forth below. Either PARTY may
initiate arbitration with respect to the matters
submitted to negotiation by filing a written demand for arbitration at any
time following the initial negotiation session.
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***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
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To the extent not resolved by mediation, any dispute, claim or
controversy arising out of or relating to this AGREEMENT or the breach,
termination, enforcement, interpretation or validity thereof, including the
determination of the scope or applicability of this AGREEMENT to arbitrate,
shall be determined by arbitration conducted in the English language. The
arbitration shall take place in [***]. The arbitration shall be
administered by [***] pursuant to its Arbitration Rules and Procedures.
References herein to any arbitration rules or procedures mean such rules or
procedures as amended from time to time, including any successor rules or
procedures, and references herein to the [***] include any successor
thereto. The arbitration shall be before [***] arbitrators. [***]. All
[***] arbitrators shall have experience in the area under dispute. This
arbitration provision, and the arbitration itself, shall be governed by the
laws of the [***], and [***] the Federal Arbitration Act, 9 U.S.C. §§ 1-16.
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Consistent with the expedited nature of arbitration, each PARTY will,
upon the written request of the other PARTY, promptly provide the other with
copies of documents on which the producing PARTY may rely in support of or
in opposition to any claim or defense. At the request of a PARTY, the
arbitrators shall have the discretion to order examination by deposition of
witnesses to the extent the arbitrator deems such additional discovery
relevant and appropriate. Depositions shall be limited to a maximum of [***]
per PARTY and shall be held within [***] days of the grant of a request.
Additional depositions may be scheduled only with the permission of the
arbitrators, and for good cause shown. Each deposition shall be limited to a
maximum of [***] duration. All objections are reserved for the arbitration
hearing except for objections based on privilege and proprietary or
confidential information. The PARTIES shall not utilize any other discovery
mechanisms, including international processes and U.S. federal statutes, to
obtain additional evidence for use in the arbitration. Any dispute regarding
discovery, or the relevance or scope thereof, shall be determined by the
arbitrators, which determination shall be conclusive. All discovery shall be
completed within [***] days following the appointment of the arbitrators.
All costs and/or fees relating to the retrieval, review and production of
electronic discovery shall be paid by the PARTY requesting such discovery.
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The panel of arbitrators shall have no power to award non-monetary or
equitable relief of any sort. [***]. The arbitrators shall have no power
or authority, under the [***] or otherwise, to relieve the PARTIES from
their agreement hereunder to arbitrate or otherwise to amend or disregard
any provision of this AGREEMENT. Subject to the provisions set forth in
Section 23(b)(v) below, the award of the arbitrators shall be final, binding
and the sole and exclusive remedy to the PARTIES. Either PARTY may seek to
confirm and enforce any final award entered in arbitration, in any court of
competent jurisdiction. The cost of the
arbitration, including the fees of the arbitrators, shall be borne by the
PARTY the arbitrator determines has not prevailed in the arbitration.
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***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
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If an arbitral award does not contain an award of money damages in excess
of [***], then the arbitral award shall not be appealable and shall only be
subject to such challenges as would otherwise be permissible under the
Federal Arbitration Act, 9 U.S.C. §§ 1-16. In the event that the
arbitration results in an arbitral award, which imposes a monetary award in
excess of [***], such award may be appealed to a tribunal of appellate
arbitrators via the [***] Appeal Procedure.
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Except as may be required by law, and except to the extent necessary for
either PARTY to seek to confirm and enforce any final award entered in
arbitration in a court of competent jurisdiction, neither a PARTY nor an
arbitrator may disclose the existence, content, or results of any
arbitration hereunder without the prior written consent of both PARTIES.
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c. [***].
7. Miscellaneous
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Full Force and Effect. Except as expressly amended by this Amendment, the
AGREEMENT shall remain unchanged and continue in full force and effect as provided
therein. |
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Entire Agreement of the Parties. This Amendment and the AGREEMENT constitute
the complete final and exclusive understanding and agreement of the PARTIES with
respect to the subject matter of the AGREEMENT, and supersede any and all prior or
contemporaneous negotiations, correspondence, understandings and agreements, whether
oral or written, between the PARTIES respecting the subject matter of the AGREEMENT. |
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Counterparts. This Amendment may be executed in two or more counterparts, each
of which shall be deemed an original, but all of which together shall constitute one
and the same instrument. One or more counterparts of this Amendment may be executed by
facsimile, electronic reproductions of signatures or other electronic means, all of
which shall be deemed originals. |
[Signature Page Follows]
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
[Signature Page to Amendment No. 4]
IN WITNESS WHEREOF, the Parties hereto have executed this Amendment in duplicate originals by
their authorized officers as of the Effective Date of Amendment No. 4.
ACCEPTED AND AGREED,
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NEKTAR THERAPEUTICS AL, CORP |
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Filed by Bowne Pure Compliance
Exhibit 10.35
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
EXECUTION COPY
EXCLUSIVE LICENSE AGREEMENT
This EXCLUSIVE LICENSE AGREEMENT (this Agreement) dated as of December 31, 2008 is entered
into by and between Novartis Pharma AG, a corporation organized under the laws of Switzerland,
having a place of business at Lichtstrasse 35, 4056, Basel, Switzerland (Licensor), and Nektar
Therapeutics, a Delaware corporation, having a place of business at 201 Industrial Road, San
Carlos, CA 94070 (the Company). Licensor and Company are each referred to herein as a Party,
and collectively, as the Parties.
RECITALS
WHEREAS, Novartis Pharmaceuticals Corporation, Licensor and Company have entered into an Asset
Purchase Agreement (the APA) for the sale and purchase of the Transferred Assets related to the
Business (each as defined in the APA); and
WHEREAS, as a condition to Closing under the APA, Licensor will grant Company certain
exclusive license under Intellectual Property included in the Transferred Assets in certain
Licensed Fields (as defined below) and Company will assign and license rights to certain
Improvements (as defined below) [***], on the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the foregoing and the mutual covenants contained herein
and other good and valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, the Parties agree as follows:
AGREEMENT
ARTICLE I
DEFINITIONS
For the purposes of this Agreement, the following terms shall have the following meanings.
All other capitalized terms used herein and not defined in this Article shall be as defined in the
body of this Agreement or the APA.
[***] means [***].
[***] means [***].
[***] means [***].
[***] means [***].
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
Collaborators means, with respect to an Existing Agreement, the Third Party(ies) who are
parties to such Existing Agreement with the Company or its Affiliate.
Company Group means, collectively, Company and each of its Affiliates.
Company Improvements means [***].
Controlled means, with respect to specific Intellectual Property, that Intellectual Property
which the applicable Party owns or has a license such that it can grant a license or sublicense
thereto as contemplated under this Agreement without violating the terms of any then-existing
agreement or other arrangement with, or the rights of, any Third Party and without additional
payment or obligation to such Third Party.
Effective Date means the date set forth in the Preamble.
Existing Agreements means [***].
Future Collaborators means Third Parties to whom the Company or Licensor or the respective
Affiliates, licenses or sublicenses, as applicable, rights granted hereunder, to the extent
permitted hereby.
Improvements means any improvement, modification, derivative, analogue, mutation,
alteration, enhancement, translation, adaptation, addition, new version or new invention,
Controlled by either Party (including, in the case of the Company, Controlled by any Future
Collaborator of the Company), solely or jointly, in or to any processes, products or materials that
are part of or related to the Business or the Licensed Intellectual Property.
[***] means [***].
[***] means [***].
Intellectual Property shall have the meaning set forth in the APA.
Know-How shall have the meaning set forth in the APA.
Licensed Field means [***].
Licensed Intellectual Property means [***].
Licensed Improvements means [***].
Licensor Group means, collectively, Licensor and each of its Affiliates.
Patent Right means any of the following, whether existing now or in the future anywhere in
the Territory: (a) any issued patent, including inventors certificates, utility model,
substitutions, extensions, confirmations, reissues, re-examination, renewal or any like
governmental grant for protection of inventions; and (b) any pending application for any of the
foregoing, including any continuation, divisional, substitution, additions,
continuations-in-part, provisional and converted provisional applications.
2
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
Product means, with respect to a Licensed Field, products or services that may be developed,
manufactured or commercialized within such Licensed Field.
Regulatory Approval means all approvals necessary, including price approval, for the
commercial sale of a therapeutic product in a given country or regulatory jurisdiction.
[***] means [***].
[***] means [***].
Select Patent Rights means the list of Patent Rights transferred to Licensor or its
Affiliates as part of the Transferred Assets under the APA described on Exhibit D.
Services Agreement means the Services Agreement attached hereto in Exhibit C, under
which Licensor or an Affiliate thereof will provide Company certain services as specified therein.
Territory means worldwide.
Third Party means any Person other than the Licensor Group and the Company Group.
[***] means [***].
ARTICLE II
LICENSES AND ASSIGNMENT
2.1 Licenses.
(a) License to Company. Subject to the terms and conditions of this Agreement,
Licensor hereby grants to Company, with the right to sublicense pursuant to Section 2.2, an
exclusive (even as to Licensor) irrevocable, perpetual, non-transferable (except pursuant to
Section 7.9), royalty-free, fully paid-up license in the Territory under the Licensed Intellectual
Property and Licensed Improvements to develop, manufacture, have manufactured, use, import, export,
sell, offer to sell or otherwise commercialize Products within the Licensed Field.
(b) License to Licensor. Subject to the terms and conditions of this Agreement,
Company hereby grants to Licensor, with the right to sublicense pursuant to Section 2.2, an
exclusive (even as to Company) irrevocable, perpetual, non-transferable (except pursuant to Section
7.9), royalty-free, fully paid-up license in the Territory under the Company Improvements to
develop, manufacture, have manufactured, use, import, export, sell, offer to sell or otherwise
commercialize products or services outside the Licensed Field. The foregoing shall not limit
Licensors rights under Section 2.1(c).
3
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
(c) Assignment to Licensor. [***].
2.2 Sublicenses. Subject to the terms and conditions of this Agreement, each Party
shall have the right to grant sublicenses (to multiple tiers of sublicensees) under the licenses
granted under this Agreement to any Affiliate or Third Party; provided that each such sublicensee
shall be subject to a written agreement with terms and condition that are consistent with, and no
less protective of, the other Party than the terms and conditions hereunder.
2.3 No Implied Licenses. Any Intellectual Property rights of a Party not expressly
granted to the other Party under the provisions of this Agreement shall be retained by such Party.
Except as expressly provided in this Agreement, Party does not grant to the other Party any right
or license in any Intellectual Property right, whether by implication, estoppel or otherwise.
2.4 Consideration. The rights and obligations provided under this Agreement are being
provided as a condition to Closing under the APA. As such, no further consideration, financial or
otherwise, will be due under this Agreement, except as expressly provided herein.
2.5 Representations and Warranties. The Company represents and warrants that it has
provided true, correct and complete copies of the Existing Agreements to Licensor. Licensor
represents and warrants that it has reviewed the Existing Agreements and understands the terms
thereof.
ARTICLE III
SERVICES
3.1 Services. Licensor shall perform or have performed certain services in connection
with the Companys or its Affiliates obligations under the Existing Agreements as and to the
extent and for the consideration provided in the Services Agreement.
ARTICLE IV
PATENT PROSECUTION AND ENFORCEMENT; DMFs
4.1 Invention Disclosures.
(a) [***].
(b) [***].
4.2 Ownership. [***].
4.3 Patent Prosecution.
4
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
(a) [***]. Licensor shall file, prosecute and maintain the [***] in manner consistent with
the standards it applies with respect to the filing, prosecution and maintenance of its own patents and patent applications. With respect to all other Patent Rights included in
the Licensed Intellectual Property and all other Patent Rights included in Improvements owned by
Licensor or its Affiliates, Licensor will be solely responsible for filing, prosecuting and
maintaining such Patent Rights in its sole discretion.
(b) [***].
(c) Patent Term Extensions. Company shall provide written notice to Licensor of any
applicable Regulatory Approval obtained by or on behalf of the Company (Company Approval) that
can provide a basis for a patent term extension of Patent Rights or Licensor Patent Rights (as
defined below) within ten (10) days of receiving such Regulatory Approval. The Parties shall
cooperate, if necessary and appropriate, with each other in gaining patent term extension based on
such Company Approval wherever applicable to Patent Rights included in the Licensed Intellectual
Property or any Patent Rights to Improvements owned by Licensor that are applicable to the Licensed
Fields (Licensor Patent Rights). The Parties shall, if necessary and appropriate, agree upon a
joint strategy relating to patent term extensions based on a Company Approval, but, in the absence
of mutual agreement with respect to any extension issue, if Licensor does not wish to file for an
extension of any Patent Rights included in the Licensed Intellectual Property and any Patent Rights
to Improvements owned by Licensor that are applicable to the Licensed Fields, then Licensor shall
timely let Company know sufficiently in advance so as to permit Company to request Licensor to file
for such extension, in which case, Licensor shall file such extension at Companys expense.
(d) Select Patent Rights. [***].
4.4 Third Party Infringement.
(a) Notice. Company shall promptly report in writing to Licensor any actual or
potential infringement that it becomes aware of related to any Licensed Intellectual Property or
Improvements related thereto, and shall provide Licensor with all available evidence supporting
such infringement or unauthorized use. Licensor shall promptly report in writing to Company any
actual infringement that it becomes aware of related to [***].
(b) Licensor Rights. [***].
(c) Company Rights. [***].
(d) Conduct of Certain Actions; Costs. [***].
(e) Recoveries. [***].
(f) Patent Invalidity Claim. [***].
4.5 Drug Master Files. The provisions set forth in Schedule 4.5 attached
hereto are hereby incorporated by reference as if fully set forth herein.
5
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
ARTICLE V
CONFIDENTIAL INFORMATION
5.1 Treatment of Confidential Information. In carrying out its obligations under this
Agreement, the Services Agreement or the Transition Services Agreement, each Party or its
Affiliates will be sharing confidential and proprietary data and information (Confidential
Information) with the other Party or its Affiliates, with such Confidential Information including,
without limitation, any information generated under this Agreement or the confidential or
proprietary information of Third Parties (including without limitation Collaborators and Future
Collaborators). For the avoidance of doubt, all such data and information relating to the Business
or the Transferred Assets, other than those related to the Retained Assets, (collectively,
Business Confidential Information) is Confidential Information of Licensor. As between the
Parties, all such data and information relating to the Retained Assets is Confidential Information
of Company. Except as expressly permitted by this Agreement, each Party shall, and shall cause its
Affiliates to, treat Confidential Information received from the other Party (the Disclosing
Party) or its Affiliates as it treats its own proprietary information of like nature and
importance to maintain the confidentiality of such Confidential Information, but in no event less
than reasonable care. During the term of this Agreement and for a period of [***] thereafter, the
Party in receipt of the Disclosing Partys Confidential Information (the Receiving Party) shall
not disclose, divulge or otherwise communicate such Confidential Information to any Third Party, or
use it for any purpose except pursuant to and in order to carry out its obligations under this
Agreement, the Services Agreement or the Transition Services Agreement. Notwithstanding the
foregoing, the Receiving Party may disclose Confidential Information of the Disclosing Party to the
Receiving Partys directors, officers, employees, Affiliates, consultants, subcontractors,
sublicensees, agents or external advisors on a need to know basis, and solely to the extent
reasonably necessary to carry out its obligations under this Agreement, the Services Agreement or
the Transition Services Agreement, provided that such directors, officers, employees, Affiliates,
consultants, subcontractors, sublicensees, agents or external advisors have been advised of the
confidential nature of such information and have agreed to maintain such information as
confidential and comply with non-use obligations to the same extent required by, and as stringent
as, this Article V.
5.2 Exceptions to Definition of Confidential Information. Confidential Information
shall not include information that the Receiving Party can demonstrate:
(a) was known by the Receiving Party or its Affiliates prior to the date it was disclosed to
the Receiving Party or its Affiliates by the Disclosing Party or its Affiliates, as evidenced by
the prior written records of the Receiving Party or its Affiliates, provided that this exception
will not apply, in the case of the Company, to any Business Confidential Information;
(b) is lawfully disclosed to the Receiving Party or its Affiliates by a Third Party rightfully
in possession of such information without an obligation of confidentiality after the date of the
disclosure to the Receiving Party or the Affiliates;
6
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
(c) becomes generally known to the public through no act or omission on the part of the
Receiving Party or its Affiliates, either before or after the date of the disclosure to the
Receiving Party or its Affiliates; or
(d) is independently developed by the Receiving Party or its Affiliates without reference or
access to, or reliance upon, any Confidential Information of the Disclosing Party or its Affiliates
as demonstrated by the Receiving Partys written records.
5.3 Permitted Disclosures. The restrictions set forth in this Article V shall not
prevent either Party from (i) disclosing Confidential Information in connection with preparing,
filing, prosecuting or maintaining the Licensed Intellectual Property in accordance with Article
IV, (ii) disclosing Confidential Information to governmental agencies to the extent required by
applicable Laws or desirable to obtain a Regulatory Approval, (iii) disclosing Confidential
Information to potential private financial institution investors (under a confidentiality agreement
at least as restrictive as the provisions of this Article V) in connection with fundraising
activities, (iv) disclosing Confidential Information to underwriters and financial advisors (under
an obligation of confidentiality at least as restrictive as the provisions of this Article V) in
connection with the public offering of securities, (v) disclosing Confidential Information that is
reasonably determined is required to be disclosed by the Receiving Party pursuant to a judicial or
governmental order, or to public investors or governmental agencies (to comply with applicable
securities or other laws) in connection with the public offering of securities or (vi) disclosing
Confidential Information as required pursuant to the exercise by each Party of its rights granted
to it under this Agreement or its retained rights (under an obligation of confidentiality at least
as restrictive as the provisions of this Article V), provided that in the cases of (i), (ii) and
(v) above, the Party disclosing Confidential Information of the Disclosing Party shall use all
reasonable efforts to provide prior written notice of such disclosure to the Disclosing Party and
to take reasonable and lawful actions to avoid or limit such disclosure (such as seeking a
protective order) or to assist the Disclosing Party in avoiding or limiting such disclosure. The
existence and terms of this Agreement, the Services Agreement and the Transition Services Agreement
shall constitute Confidential Information of both Parties, provided, however, that each Party may
disclose the existence and terms of such agreements to (i) [***], (ii) to its attorneys and
advisors with a need to know, (iii) potential acquirers in connection with a potential change of
control or sale of all or substantially all of the assets to which this Agreement relates (provided
that such disclosure is limited solely to principal financial terms disclosed to potential
acquirers financial advisers and otherwise solely to potential acquirers counsel on an attorneys
only basis) as part of their due diligence investigation, (iv) to potential financial
institutional investors or lenders of such Party, as a part of their due diligence investigations,
and (v) subject to the foregoing, to Assignees, provided, that in each of the foregoing cases
referenced in clauses (i)-(v) above, such disclosure is made under an agreement to keep the terms
of this Agreement, the Services Agreement and the Transition Services Agreement confidential under
an obligation of confidentiality at least as restrictive as the provisions of this Article V.
7
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
ARTICLE VI
TERM AND TERMINATION
6.1 Term. The term of this Agreement shall commence on the Effective Date and shall
continue until the expiration of the last to expire of the Patent Rights included in the Licensed
Intellectual Property and the Licensed Improvements, unless sooner terminated as specifically
provided in this Agreement.
6.2 Bankruptcy. Any licenses granted under or pursuant to this Agreement by either
Party to the other Party are, and shall otherwise be deemed to be, for purposes of Section 365(n)
of Title 11, US Code (the Bankruptcy Code), licenses of rights to intellectual property as
defined under Section 101(35A) of the Bankruptcy Code. The Parties agree that during the term of
this Agreement, each Party, as a licensee of rights under this Agreement, shall retain and may
fully exercise all of its rights and elections under the Bankruptcy Code, subject to the continued
performance of its obligations under this Agreement.
6.3 Survival of Obligations. Sections [***] and any definitions used in any such
Sections and Articles shall survive the termination of this Agreement in accordance with their
terms. Termination or expiration of this Agreement shall not relieve either Party from any accrued
obligations prior to such termination or expiration. Termination is not intended to be an
exclusive remedy and is without prejudice to any other rights and remedies of the Parties under
this Agreement at law or in equity.
ARTICLE VII
MISCELLANEOUS
7.1 Disclaimer of Warranty. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN THIS
AGREEMENT OR THE APA, NEITHER PARTY MAKES ANY REPRESENTATIONS AND GRANTS NO WARRANTIES, EXPRESS OR
IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE RELATED TO THE LICENSED
INTELLECTUAL PROPERTY AND LICENSED IMPROVEMENTS, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER
REPRESENTATIONS AND WARRANTIES, WHETHER WRITTEN OR ORAL, EXPRESS, STATUTORY OR IMPLIED, INCLUDING
ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE.
7.2 Governing Law. This Agreement (and any claims or disputes arising out of or
related hereto or to the transactions contemplated hereby or to the inducement of any party to
enter herein, whether for breach of contract, tortious conduct or otherwise and whether predicated
on common law, statute or otherwise) shall in all respects be governed by, and construed in
accordance with, the laws of the State of New York, including all matters of construction, validity
and performance, in each case without reference to any conflict of law rules that might lead to the
application of the laws of any other jurisdiction.
8
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
7.3 Force Majeure. Neither Party shall be responsible to the other Party for
nonperformance or delay in performance of the terms or conditions of this Agreement due to acts of
God, acts of governments, war (declared or undeclared), acts of terrorism, riots, strikes,
accidents in transportation, or other causes beyond the reasonable control of such Party, but such
force majeure shall toll any and all obligations and time periods for so long as such force majeure
continues. Upon the occurrence of an event of force majeure, the Party whose performance is
affected thereby shall notify the other Party promptly of such event. Upon the cessation of such
event, such Party shall take all reasonable steps within its power to resume with the least
possible delay compliance with its obligations hereunder.
7.4 Waiver. The waiver by a Party of a breach or a default of any provision of this
Agreement by the other Party shall not be construed as a waiver of any subsequent breach of the
same or any other provision hereof, nor shall any delay or omission on the part of a Party to
exercise or avail itself of any right, power or privilege that it has or may have hereunder operate
as a waiver of that or any other right, power or privilege of such Party hereunder.
7.5 Notices. Any notice or other communication required or permitted to be given in
connection with this Agreement must be in writing and may be given by any of the following methods:
(i) personal delivery with a signed acknowledgement of receipt; (ii) registered or certified mail,
postage prepaid, return receipt requested; or (iii) by overnight delivery service with a signed
acknowledgement of receipt. Notice shall be effective when delivered to the addressee at the
address listed below or such other address as the addressee shall have specified in a written
notice actually received by the addresser.
(a) if to the Company, to it at:
Nektar Therapeutics
201 Industrial Road
San Carlos, California 94070
Attention: Gil M. Labrucherie
Facsimile: (650) 620-5360
with copies to:
OMelveny & Myers LLP
2765 Sand Hill Road
Menlo Park, California 94025
Attention: Sam Zucker
Facsimile: (650) 473-2601
(b) if to the Licensor, to it at:
Novartis Pharma AG
Lichtstrasse 35
CH-4056 Basel
Switzerland
Attention: General Counsel
9
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
Facsimile: + (41) (61) 324-6859
and
with copies to:
Novartis International AG
Lichtstrasse 35
CH-4056 Basel
Switzerland
Attention: Global Head Legal M&A and Antitrust
Facsimile: + (41) (61) 324-7476
and
Novartis International AG
Lichtstrasse 35
CH-4056 Basel
Switzerland
Attention: Head Corporate Intellectual Property
Facsimile: + (41) (61) 324-7424
and
Kaye Scholer LLP
425 Park Avenue
New York, New York 10022
Attention: Adam Golden
Facsimile: +1 (212) 836-8689
7.6 (a) Relationship of the Parties. The Parties are independent contractors.
Nothing herein is intended, or shall be deemed, to constitute a partnership, agency, joint venture
or employment relationship between the Parties. Neither Party shall be responsible for the other
Partys acts or omissions [***]; and neither Party shall have authority to speak for, represent or
obligate the other Party in any way without prior written authority from the other Party. Subject
to the terms of this Agreement, the activities and resources of each Party shall be managed by such
Party, acting independently and in its individual capacity.
(b) Subcontractor Status. [***].
(c) No Amendments. [***].
10
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
(d) Indemnification; Limitation of Liability. In connection with performing its
obligations under Article IV hereof, Licensor and its Affiliates will be entitled to the benefit of
the indemnity and limitation of liability provisions set forth in Article IV of the Services
Agreement, as if fully set forth herein.
(e) Standard of Performance. [***].
7.7 Entire Agreement. This Agreement and the Exhibits attached hereto (which Exhibits
are incorporated herein by reference and are deemed to be a part of this Agreement for all
purposes) constitute the entire agreement of the Parties with respect to the subject matter hereof
and supersede all prior understandings and writings between the Parties relating thereto; provided
that the terms of this Agreement should be interpreted to be consistent with the terms of the APA
and are not intended to modify the Parties respective rights and obligations under the APA. No
amendment, waiver, alteration or modification of any of the provisions of this Agreement shall be
binding unless made in writing and signed by the Parties.
7.8 Severability. In the event that any provision of this Agreement is held by a
court of competent jurisdiction to be unenforceable because it is invalid or in conflict with any
law of any relevant jurisdiction, the validity of the remaining provisions of this Agreement shall
not be affected thereby, and the Parties shall negotiate a substitute provision that, to the extent
possible, accomplishes the original business purpose of the unenforceable provision. During the
period of such negotiation, and thereafter if no substituted provision is agreed upon in writing by
the Parties, any such provision which is enforceable in part but not in whole shall be enforced to
the maximum extent permitted by law.
7.9 Assignment and Transfer.
(a) Neither this Agreement nor any right or obligation hereunder may be assigned or otherwise
transferred by the Company without the prior written consent of the Licensor, except the Company
may, without consent of the Licensor, assign or otherwise transfer this Agreement and its rights
and obligations hereunder in whole or in part: (i) to any Affiliate; (ii) in connection with a
merger, reorganization or a sale or transfer of all or substantially all of the assets to which
this Agreement relates or (iii) as part of the transfer of all or one or more programs inside the
Licensed Field. Licensor shall be entitled to freely assign its rights or obligations hereunder.
Any attempted assignment or other transfer not in accordance with this Section 7.9 shall be void.
Any permitted assignee shall assume in writing all assigned obligations of its assignor under this
Agreement. The Party making any assignment or other transfer permitted under this Section 7.9
shall provide prompt written notice to the other Party of such assignment or transfer. The
assignor shall remain jointly and severally liable with any such assignee(s) with respect to all
obligations and liabilities of the assignor hereunder.
(b) Successors and Assigns. Except as otherwise provided herein, this Agreement shall
be binding upon and inure to the benefit of the Parties hereto and their successors and permitted
assigns.
11
***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
7.10 Interpretation. Unless the context of this Agreement otherwise requires, (a)
words of one gender include the other gender; and (b) words using the singular or plural number also include the plural or singular number, respectively. Reference to days are to
calendar days unless specified otherwise. References to any statute, act, or regulation are to
that statute, act, or regulation as amended, modified or supplemented from time to time in
accordance with the terms hereof and thereof. The headings contained in this Agreement are for
convenience of reference only and shall not be considered in interpreting this Agreement. Any
capitalized terms used in any Exhibit but not otherwise defined therein, shall have the meaning as
defined in this Agreement. The words hereof, herein and hereunder and words of like import
used in this Agreement shall refer to this Agreement as a whole and not to any particular provision
of this Agreement. Whenever the words include, includes or including are used in this
Agreement, they shall be deemed to be followed by the words without limitation, whether or not
they are in fact followed by those words or words of like import. Writing, written and
comparable terms refer to printing, typing and other means of reproducing words (including
electronic media) in a visible form. This Agreement is a negotiated document between the two
Parties and shall not be construed against the drafter of any particular provision.
7.11 Counterparts. This Agreement may be executed manually, electronically in Adobe®
PDF file format, or by facsimile by the Parties, in any number of counterparts, each of which shall
be considered one and the same agreement and shall become effective when a counterpart hereof shall
have been signed by each of the Parties and delivered to the other Party.
7.12 Further Actions. Each Party will duly execute and deliver, or cause to be duly
executed and delivered, such further instruments and do and cause to be done such further acts and
things, as may be reasonably necessary or as the other Party may reasonably request in connection
with this Agreement in order to carry out more effectively the provisions and purposes hereof.
12
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be duly executed as of
the date first above written.
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NEKTAR THERAPEUTICS |
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By:
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/s/ Gil M. Labrucherie |
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Name:
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Gil M. Labrucherie |
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Title:
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SVP & General Counsel |
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NOVARTIS PHARMA AG |
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By:
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/s/ Jörg Walther |
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Name:
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Jörg Walther |
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Title:
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Authorized Signatory |
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By:
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/s/ Cristina Ruggeberg |
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Name:
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Cristina Ruggeberg |
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Title:
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Authorized Signatory |
Filed by Bowne Pure Compliance
Exhibit 21.1
Subsidiaries of Nektar Therapeutics*
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Name |
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Jurisdiction of Incorporation or Organization |
Nektar Therapeutics AL, Corporation
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Alabama |
Nektar Therapeutics UK, Ltd.
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United Kingdom |
Inhale Therapeutic Systems Deutschland GmbH
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Germany |
Nektar Therapeutics (India) Pvt. Ltd
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India |
Aerogen, Inc.
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Delaware |
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* |
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Includes subsidiaries that do not fall under the definition of
Significant Subsidiary as defined under Rule 1-02(w) of Regulation
S-X. |
Filed by Bowne Pure Compliance
Exhibit 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the incorporation by reference in the Registration Statements (Form S-8 Nos. 333-07969, 333-59735,
333-65919, 333-74669, 333-32788, 333-54078, 333-55032, 333-67342, 333-71936, 333-76638, 333-98321, 333-103040,
333-117975, 333-136498, 333-145259 and 333-153106) pertaining to the amended and restated 1994 Equity
Incentive Plan, the 1998 Non-Officer Equity Incentive Plan, the 2000 Non-Officer Equity Incentive Plan, the 401(k)
Retirement Plan, the Employee Stock Purchase Plan, the 2000 Equity Incentive Plan, the 2008 Equity Incentive Plan, the
Bradford Particle Design plc Share Option Schemes, the Shearwater Corporation 1996 Nonqualified Stock Option Plan, and
in the Registration Statements (Form S-3 Nos. 333-54080, 333-108859, 333-120009, 333-67340, 333-130591) of Nektar
Therapeutics, and in the related Prospectuses, of our reports dated
March 4, 2009, with respect to the consolidated
financial statements and schedule of Nektar Therapeutics, and the effectiveness of internal control over financial
reporting of Nektar Therapeutics included in this Annual Report Form 10-K for the year ended December 31, 2008.
/s/ Ernst & Young LLP
San Jose, California
March 4, 2009
Filed by Bowne Pure Compliance
Exhibit 31.1
CERTIFICATIONS
I, Howard W. Robin, certify that:
1. I have reviewed this Annual Report on Form 10-K of Nektar Therapeutics for the year ended
December 31, 2008;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact
or omit to state a material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect to the period
covered by this report;
3. Based on my knowledge, the financial statements and other financial information included in
this report, fairly present in all material respects the financial condition, results of operations
and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer(s) and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) and internal control over financial reporting (as defined in Exchange Act rules
13a-15(f) and 15d-15(f)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls
and procedures to be designed under my supervision, to ensure that material information
relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being
prepared;
b) Designed such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under my supervision, to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrants disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the disclosure controls and
procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrants internal control over financial
reporting that occurred during the registrants most recent fiscal quarter (the registrants
fourth fiscal quarter in the case of an annual report) that has materially affected, or is
reasonably likely to materially affect, the registrants internal control over financial
reporting.
5. The registrants other certifying officer(s) and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the audit
committee of the registrants board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to adversely affect the
registrants ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who
have a significant role in the registrants internal control over financial reporting.
Date: March 6, 2009
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/s/ Howard W. Robin
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Howard W. Robin |
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Chief Executive Officer, President and Director |
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Filed by Bowne Pure Compliance
Exhibit 31.2
CERTIFICATIONS
I, John Nicholson, certify that:
1. I have reviewed this Annual Report on Form 10-K of Nektar Therapeutics for the year ended
December 31, 2008;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact
or omit to state a material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect to the period
covered by this report;
3. Based on my knowledge, the financial statements and other financial information included in
this report, fairly present in all material respects the financial condition, results of operations
and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer(s) and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) and internal control over financial reporting (as defined in Exchange Act rules
13a-15(f) and 15d-15(f)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls
and procedures to be designed under my supervision, to ensure that material information
relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being
prepared;
b) Designed such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under my supervision, to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrants disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the disclosure controls and
procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrants internal control over financial
reporting that occurred during the registrants most recent fiscal quarter (the registrants
fourth fiscal quarter in the case of an annual report) that has materially affected, or is
reasonably likely to materially affect, the registrants internal control over financial
reporting.
5. The registrants other certifying officer(s) and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the audit
committee of the registrants board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to adversely affect the
registrants ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who
have a significant role in the registrants internal control over financial reporting.
Date: March 6, 2009
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/s/ John Nicholson
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John Nicholson |
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Senior Vice President and
Chief Financial Officer |
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Filed by Bowne Pure Compliance
Exhibit 32.1
SECTION 1350 CERTIFICATIONS*
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of
1934, as amended (the Exchange Act), and Section 1350 of Chapter 63 of Title 18 of the United
States Code (18 U.S.C. § 1350), Howard W. Robin, Chief Executive Officer, President and Director of
Nektar Therapeutics (the Company), and John Nicholson, Senior Vice President and Chief Financial
Officer of the Company, each hereby certifies that, to the best of his knowledge:
1. The Companys Annual Report on Form 10-K, for the year ended December 31, 2008, to
which this Certification is attached as Exhibit 32.1 (the Annual Report), fully complies with
the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended;
and
2. The information contained in the Annual Report fairly presents, in all material
respects, the financial condition and results of operations of the Company for the period
covered by the Annual Report.
Dated: March 6, 2009
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/s/ Howard W. Robin
Howard W. Robin
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/s/ John Nicholson
John Nicholson
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Chief Executive Officer, President and Director
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Senior Vice President and Chief Financial Officer |
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* |
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This certification accompanies the Annual Report on Form 10-K, to which it relates, is not deemed
filed with the Securities and Exchange Commission and is not to be incorporated by reference into
any filing of the Company under the Securities Act of 1933, as amended, or the Securities Exchange
Act of 1934, as amended (whether made before or after the date of the Form 10-K), irrespective of
any general incorporation language contained in such filing. |