LICENSE AGREEMENT by and between ASTRAZENECA AB and NEKTAR THERAPEUTICS DATE: September 20, 2009
Exhibit
10.1
EXECUTION VERSION
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Omitted and Filed Separately with the Securities and Exchange
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Confidential Treatment Requested Under
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C.F.R. Sections 200.80(b)(4) and 240.24b-2
by
and between
ASTRAZENECA
AB
and
DATE: September
20, 2009
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This
License Agreement (the “Agreement”) is made as of the
twentieth (20th) day of September, 2009 (the “Execution Date”), by and
between:
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(1)
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ASTRAZENECA
AB, a Swedish corporation with offices at X-000 00 Xxxxxxxxxx, Xxxxxx
(“AstraZeneca”);
and
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(2)
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Nektar
Therapeutics, a Delaware corporation with offices at 000 Xxxxxxxxxx Xxxx,
Xxx Xxxxxx, Xxxxxxxxxx, XXX 00000 (“Nektar”).
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Recitals
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(A)
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WHEREAS,
Nektar has developed and owns intellectual property covering a pegylated
form of the opioid receptor antagonist naloxol for the treatment and
prevention of opioid-induced
constipation;
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(B)
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WHEREAS,
Nektar has specialized experience in the pegylation of small molecule
compounds;
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(C)
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WHEREAS,
AstraZeneca and its Affiliates have specialized experience in, among other
things, the development and commercialization of pharmaceutical
compounds worldwide; and
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(D)
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WHEREAS,
Nektar desires to grant a license to AstraZeneca, and AstraZeneca desires
to take a license, to develop and commercialize the above-mentioned
pharmaceutical compound and related compounds and products, including
combination products, in accordance with the terms and conditions set
forth below.
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Agreement
NOW,
THEREFORE, in consideration of the mutual covenants contained in this Agreement,
and other good and valuable consideration, the receipt and sufficiency of which
are hereby acknowledged, the Parties, intending to be legally bound, agree as
follows:
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1.
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Definitions
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Unless
otherwise specifically provided herein, the following terms, when used with a
capital letter at the beginning, shall have the following meanings:
1.1. “[***]”
means (a) those Patents described as [***] of this Agreement, (b) any Patents
claiming priority from any such Patents, and (c) any foreign equivalents of any
of the foregoing.
1.2. “[***]”
means a [***] that has been added to the scope of Licensed Products pursuant to
Section 7.4 or 7.10(b), as applicable.
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1.3. “Adverse
Event” means the development of an undesirable medical condition or the
deterioration of a pre-existing medical condition in a patient or clinical
investigation subject following or during exposure to or use of a Licensed
Product, whether or not considered causally related to the Licensed Product, the
exacerbation of any pre-existing condition(s) occurring following or during the
use of the Licensed Product, or any other adverse experience or adverse drug
experience (as described in the FDA’s Investigational New Drug safety reporting
and NDA post-marketing reporting regulations, 21 C.F.R. §§ 312.32 and 314.80,
respectively, and any applicable corresponding regulations outside the United
States, in each case as may be amended from time to time) occurring following or
during exposure to or use of a Licensed Product. For purposes of this
Agreement, “undesirable medical condition” shall include symptoms (e.g., nausea, chest pain),
signs (e.g.,
tachycardia, enlarged liver) or the abnormal results of an investigation (e.g., laboratory findings,
electrocardiogram), including unfavorable side effects, toxicity, injury,
overdose or sensitivity reactions.
1.4. “Affiliate”
means, with respect to a particular Person, any other Person that directly, or
indirectly through one or more intermediaries, controls, is controlled by or is
under common control with such first Person. “Control” as used in
this definition, and, with correlative meanings, the terms “controlled by” and
“under common control with”, means the power to direct and control the
management or policies of the applicable Person, whether through ownership of
voting securities or by contract relating to voting rights or corporate
governance, resolution, regulation or otherwise; provided, however, that with
respect to MedImmune Ventures, Inc. and any other subsidiary of MedImmune, LLC
or MedImmune Limited that is primarily involved in investing in other companies,
such subsidiaries shall not be deemed to “Control” any other Person unless, in
addition to satisfying the foregoing voting control requirement, such MedImmune
subsidiary directly or indirectly owns more than fifty percent (50%) of the
outstanding voting securities or other ownership interest of such
Person.
1.5. “Agreement”
has the meaning set forth in the preamble.
1.6. “Ancillary
Agreement” means, collectively, any Development Agreement, the Safety Agreement
and the Manufacture and Technology Transfer Agreement.
1.7. “ANDA
Act” has the meaning set forth in Section 16.4.
1.8. “Annual
Net Sales” means the aggregate Net Sales made during a given Calendar
Year.
1.9. “Applicable
Law” means the applicable laws, rules and regulations, including any rules,
regulations, guidelines or other requirements of the Health Authorities, that
may be in effect from time to time.
1.10. “AstraZeneca
Party” has the meaning set forth in Section 14.2.
1.11.
“At-Issue Product” has the meaning set forth in Section 7.3.
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1.12.
“Authorized Generic Version” means, with respect to a particular Licensed
Product being sold in a particular country, any other pharmaceutical product
that (a) is sold under the Health Registration Approval for such Licensed
Product in such country by or under the authority of AstraZeneca or its
Affiliate, (b) is sold under a different Trademark than such Licensed
Product (as sold by AstraZeneca and it Affiliates), and (c) in the United
States, has a National Drug Code (“NDC”) number that differs from
the NDC number for such Licensed Product (other than on a temporary basis as may
be necessary to launch the second product in the applicable
market). For clarity, an “Authorized Generic Version” is a Licensed
Product for all purposes of this Agreement.
1.13. “AZ
Program Data” means any and all documentation, data and other
Information Controlled by AstraZeneca and in tangible form at the
time of termination of the Agreement that (a) have been generated in connection
with the research or development of [***], and (b) are [***] to enable Nektar to
develop (including seeking and obtaining Health Registration Approvals), or
[***] to enable Nektar to commercialize, the [***] in the [***] (in the case of
a partial termination of this Agreement) or the Territory (in the case of the
termination of this Agreement in its entirety), as applicable.
1.14. “AZ
Trigger Event” means, [***], the earlier to occur of (a) [***] and (b) the [***]
anniversary of the date of the first written communication by or on behalf of
AstraZeneca with the patent office in such country (provided that such date
shall be extended to account for unanticipated patent office delays or other
events outside of the control of
AstraZeneca). [***].
1.15. “Bankruptcy
Code” means Xxxxx 00, Xxxxxx Xxxxxx Code, as amended, or analogous provisions of
Applicable Law outside the United States.
1.16. “Breaching
Party” has the meaning set forth in Section 18.5(a).
1.17. “Calendar
Quarter” means each successive period of three (3) calendar months commencing on
1st January, 1st April, 1st July and 1st October.
1.18. “Calendar
Year” means each successive period of twelve (12) calendar months commencing on
1st January.
1.19. “Change
of Corporate Control” means the occurrence of any of the following:
(a) Nektar
enters into a merger, consolidation, stock sale or sale or transfer of all or
substantially all of the assets, or other similar transaction or series of
transactions with another Person unless, in the case of a merger, consolidation,
stock sale, or other similar transaction or series of transactions, following
such transaction or transactions, (i) the Persons who were the beneficial owners
of the outstanding voting securities of Nektar immediately prior to such
transaction beneficially own, directly or indirectly, at least fifty percent
(50%) of the combined voting power of the then outstanding voting securities
entitled to vote generally in the election of directors or similar governing
persons of the corporation or other entity resulting from such transaction
(“Successor”), and (ii)
at least fifty percent (50%) of the members of the Board of Directors or similar
governing body of the Successor were members of the Board of Directors of Nektar
at the time of the execution of the initial agreement, or the action of the
Board of Directors of Nektar, providing for such transaction.
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(b) any
transaction or series of related transactions in which any Person or group of
related Persons acquires beneficial ownership of securities of Nektar
representing more than [***] of the combined voting power of the then
outstanding securities of Nektar.
1.20. “Combination
Product” means a product in form suitable for human, veterinary or agricultural
applications that (a) contains a Compound as an active ingredient together with
one or more other active ingredients [***], and (b) is sold as a fixed dose
combination, including any Opioid Combination Product (but excluding for clarity
any Packaged 118 Opioid Products).
1.21. “Commercial
Launch Bonus Milestone” has the meaning set forth in Section
7.10(a)(ii).
1.22. “Commercially
Reasonable Efforts” means, with respect to the research, development,
Manufacture or commercialization of a Compound or Licensed Product, as the case
may be, conducting such tasks using such efforts and resources that are
typically used by AstraZeneca in conducting the same tasks on its own compounds
or products with similar commercial and scientific potential at a similar stage
in their lifecycle and in a similar therapeutic area, taking into consideration
their safety and efficacy, their cost to develop, the competitiveness of
alternative compounds and products and the nature and extent of their market
exclusivity (including Patent coverage and regulatory exclusivity), the
likelihood of Regulatory Approval, their expected profitability, including the
amounts of marketing and promotional expenditures with respect to the Licensed
Products and Generic Products, and all other factors that are typically taken
into consideration by AstraZeneca when determining the level of efforts and
resources to apply to such tasks with respect to its own similar compounds or
products (as described above). Commercially Reasonable Efforts shall
be determined with respect to a specific market or groups of markets (taking
account of effects outside of such markets, if any). For the
avoidance of doubt, the commitment to use “Commercially Reasonable Efforts”
shall not preclude (a) the suspension or discontinuance of specific efforts by
AstraZeneca with respect to any particular Licensed Product, if such suspension
or discontinuance is appropriate and would typically be effected by AstraZeneca
with respect to its own similar compounds or products, based on all of the
foregoing considerations, and (b) the delay of or decision not to launch
commercial sales of the Licensed Product in a given country, if such delay or
decision not to launch is appropriate and is consistent with AstraZeneca’s usual
actions with respect to a similar product of its own in such circumstances, in
each case ((a) and (b)), given all the relevant circumstances and based on all
of the foregoing considerations at the time.
1.23. “Committee”
has the meaning set forth in Section 3.4.
1.24. “Competing
Product” has the meaning set forth in Section 4.5(c)(i).
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1.25. “Competing
Product IP” has the meaning set forth in Section 4.6.
1.26. “Competitive
Indications” means [***].
1.27. “Competitive
Measurements” has [***].
1.28. “Complaining
Party” has the meaning set forth in Section 18.5(a).
1.29. “Compound”
means (a) NKTR-118, or (b) [***], or (c) [***] or (d) [***].
1.30.
“Confidential Information” of a Party means, subject to Section 11.3, any and
all data, results, know-how (including the Licensed Know-How), plans, business
information and other Information, whether oral or in writing or in any other
form, disclosed before, on or after the date of this Agreement by or on behalf
of such Party (or any of its Affiliates) to the other Party (or any of its
Affiliates).
1.31. “Confidentiality
Agreement” means that certain Amended and Restated Confidential Disclosure
Agreement executed as of August 18, 2009 and made effective as of October 25,
2007 by and between Nektar and AstraZeneca UK Limited.
1.32. “Control”
means, with respect to any item of Information, Patent or Intellectual Property
Right, that the applicable Party or its Affiliates owns or has a license under
such Information, Patent or Intellectual Property Right and has the legal right
to assign, or grant a license, sublicense or other applicable right to or under,
such Information, Patent or Intellectual Property Right to the other Party as
provided for herein without violating the terms of any agreement or other
arrangement with any Third Party.
1.33. “Counterparty”
has the meaning set forth in Section 21.4.
1.34. “Counterparty
Affiliate” has the meaning set forth in Section 21.4.
1.35. “CREATE
ACT” has the meaning set forth in Section 15.4.
1.36. “Cure
Period” has the meaning set forth in Section 18.5(a).
1.37.
1.38. “Delay
Event Development Activity” has the meaning [***].
1.39. “Delay
Period” has the meaning [***].
1.40. “Delay
Week” has the meaning [***].
1.41. “Development
Agreement” has the meaning set forth in Section 6.5.
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1.42. “Development
Plan” has the meaning set forth in Section 6.2.
1.43. [***].
1.44. “Disclosing
Party” has the meaning set forth in Section 11.2.
1.45. “Dispute”
has the meaning set forth in Section 19.1.
1.46. “Distributor”
has the meaning set forth in Section 4.3.
1.47. “Effective
Date” has the meaning set forth in Section 18.2.
1.48. “Embodiments
of Intellectual Property” has the meaning set forth in Section
18.18.
1.49. “EMEA”
means the European Medicines Agency, and any successor agency
thereto.
1.50. “End
of Phase II Meeting” has the meaning set forth in Section 6.7(e).
1.51. “Enforcing
Party” has the meaning set forth in Section 16.5.
1.52. “[***]”
means the earlier of: (a) the date [***] following the [***], and (b)
the date on which AstraZeneca (after discussion with the JPT) [***] as set forth
in Section 6.2.
1.53. “Europe”
means the European Economic Area as it may be constituted from time to
time.
1.54. “Excluded
Know-How” means any Information that relates to Compounds or Licensed Products
or their manufacture or use and is licensed or acquired by Nektar or its
Affiliate from a Third Party after the Effective Date rights to which
AstraZeneca rejects pursuant to Section 9.3.
1.55. “Excluded
Patents” means any Patent rights that claim or cover Compounds or Licensed
Products or their manufacture or use and are licensed or acquired by Nektar or
its Affiliate from a Third Party after the Effective Date and which AstraZeneca
rejects pursuant to Section 9.3(c).
1.56. “Excluded
Sublicensee” means a Sublicensee for which AstraZeneca has elected pursuant to
Section 7.6(a) to compensate Nektar as provided in Section 7.6(c) of this
Agreement.
1.57. “Execution
Date” has the meaning set forth in the preamble.
1.58. “Executives”
means, (a) with respect to AstraZeneca, the President and CEO of AstraZeneca AB
and (b) with respect to Nektar, the CEO of Nektar.
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1.59. “Existing
Product” means the Stand-Alone Product containing NKTR-118 that was the subject
of the clinical trial under protocol number [***].
1.60. “Existing
Publications” has the meaning set forth in Section 6.9(a).
1.61. “Existing
Reversion Product” means any Reversion Product that is or has been the subject
of clinical development or commercialization, as such Reversion Product
[***].
1.62. “Exploit”
means to make, have made, import, use, sell, or offer for sale, including to
research, develop, register, modify, enhance, improve, Manufacture, have
Manufactured, hold/keep (whether for disposal or otherwise), formulate,
optimize, have used, export, transport, distribute, promote, market or have sold
or otherwise dispose or offer to dispose of, a product or process.
1.63. “Exploitation”
means the act of Exploiting a product or process.
1.64. “FDA”
means the United States Food and Drug Administration and any successor agency
thereto.
1.65. “FFDCA”
means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301,
et. seq., as it may be
amended from time to time, and the rules, regulations, guidances, guidelines,
and requirements promulgated or issued thereunder.
1.66. “Field
Infringement” has the meaning set forth in Section 16.2(a).
1.67. “First
Commercial Sale” means the first sale for monetary value for use or consumption
by the general public of a Licensed Product in any country in the Territory
after Health Registration Approval for such Licensed Product has been obtained
in such country. For the avoidance of doubt, sales prior to receipt
of all Health Registration Approvals necessary to commence regular commercial
sales, such as so-called “treatment IND sales”, “named patient sales” and
“compassionate use sales”, shall not be construed as a First Commercial
Sale.
1.68. “First
Enforcing Party” has the meaning set forth in Section 16.3.
1.69. “Force
Majeure” has the meaning set forth in Section 22.1(a).
1.70. “Force
Majeure Party” means a Party prevented or delayed in its performance under this
Agreement by an event of Force Majeure.
1.71. “Generic
Product” means, with respect to a Licensed Product, a product sold by a Third
Party that (a) contains a Compound as
an active ingredient, and (b) has been approved for sales introduction into
interstate commerce by reference to such Licensed Product pursuant to
(i) Section 505(b)(2) or Section 505(j) of the FFDCA (21 U.S.C. 355(b)(2)
and 21 U.S.C. 355(j), respectively), (ii) Articles 10(1), 10(2), 10(3), 10(4) or
10a of Directive 2001/83/EC of the European Parliament and of the Council of 6
November 2001 on the Community code relating to medicinal products for human
use, each as amended, or (iii) any similar approval in any country, which
similar approval is based on reference to the Health Registration Approval for
such Licensed Product in such country and a demonstration of bio-equivalence or
similarity to such Licensed Product, but excluding for clarity all
Licensed Products, including Opioid Combination Products and Authorized Generic
Versions, sold by AstraZeneca, its Affiliates, Sublicensees and
Distributors.
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1.72. “Good
Manufacturing Practice” or “cGMP” means applicable current good manufacturing
practices for pharmaceutical products (and components thereof) as described in
regulations promulgated by the applicable Health Authority, as amended from time
to time.
1.73. “Grant-Back
Patents” has the meaning set forth in Section 18.12(a).
1.74. “Health
Authority” means any applicable supra-national, federal, national, regional,
state, provincial or local regulatory agencies, departments, bureaus,
commissions, councils or other government entities regulating or otherwise
having legal authority with respect to the Exploitation of Compounds or Licensed
Products in the Territory.
1.75. “Health
Registration Approval” means, with respect to a country in the Territory, any
and all approvals, licenses, registrations or authorizations of any Health
Authority necessary to commercially distribute, sell and market a Licensed
Product in such country, including, where applicable, (a) pricing or
reimbursement approval in such country, (b) pre- and post-approval marketing
authorizations (including any prerequisite Manufacturing approval or
authorization related thereto), (c) labeling approval and (d) technical, medical
and scientific licenses.
1.76. “HSR
Act” means the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as
amended.
1.77. “HSR
Filing” has the meaning set forth in Section 18.1.
1.78. “Improvement”
means any invention, discovery, development or modification with respect to a
Compound or Licensed Product or directly relating to the Exploitation thereof,
whether or not patented or patentable, that is conceived, reduced to practice,
discovered, developed or otherwise made at any time during the Term, including
any enhancement in the efficiency, operation, Manufacture, ingredients,
preparation, presentation, formulation, means of delivery or dosage of such
Compound or Licensed Product, any discovery or development of any new or
expanded indications for such Compound or Licensed Product, any discovery or
development that improves the stability, safety or efficacy of such Compound or
Licensed Product, or any discovery or development of new Compounds.
1.79. “Included
Sublicensees” means a Sublicensees for which AstraZeneca has elected pursuant to
Section 7.6(a) to compensate Nektar as provided in Section 7.6(b) (by including
in the calculation of royalties based on Net Sales the sales of Licensed
Products by such Sublicensee).
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1.80. “IND”
means an investigational new drug application filed with the FDA for
authorization to commence human clinical trials in the U.S., and its equivalent
in other countries or regulatory jurisdictions in the Territory.
1.81. “Indemnification
Claim Notice” has the meaning set forth in Section 14.3.
1.82. “Indemnified
Party” means a Party, its Affiliates or its or their respective directors,
officers, employees, agents, partners and shareholders seeking to recover a Loss
under Section 14.1 or 14.2.
1.83. “Indemnifying
Party” means a Party from whom recovery of a Loss is sought under Section 14.1
or 14.2.
1.84. “Indirect
Taxes” means value added taxes, sales taxes, consumption taxes and other similar
taxes.
1.85. “Information”
means all technical, scientific, business and other know-how and information,
trade secrets, knowledge, technology, means, methods, processes, practices,
formulae, instructions, skills, techniques, procedures, experiences, ideas,
technical assistance, designs, drawings, assembly procedures, computer programs,
apparatuses, specifications, data, results, laboratory notes and notebooks, and
other material, including: high-throughput screening, gene expression, genomics,
proteomics and other drug discovery and development technology; formulation;
biological, chemical, pharmacological, toxicological, pharmaceutical, physical
and analytical, pre-clinical, clinical, safety, manufacturing and quality
control data and information, including study designs and protocols; assays and
biological methodology; Manufacturing and quality control procedures and data,
including test procedures; and synthesis, purification and isolation techniques,
(whether or not confidential, proprietary, patented or patentable) in written,
electronic or any other form now known or hereafter developed, and any products,
apparatuses, cultures, biological materials and other materials and
compositions, but excluding the Regulatory Documentation.
1.86. “Infringement
Suit” has the meaning set forth in Section 17.3.
1.87. “Initial
Phase III Program” has the meaning set forth in Section 6.3.
1.88. “Intellectual
Property Rights” means trademarks, service marks, trade secrets, trade names,
registered designs, design rights, copyrights (including rights in computer
software), domain names, database rights and any rights or property similar to
any of the foregoing (other than Patents) in any part of the world, whether
registered or not, together with the right to apply for the registration of any
such rights.
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1.89. “Invalidity
Action” has the meaning set forth in Section 17.2(a).
1.90. “IP”
has the meaning set forth in Section 18.18(a).
1.91. “Joint
Know-How” has the meaning set forth in Section 9.4.
1.92. “Joint
Patents” has the meaning set forth in Section 9.4.
1.93. “Joint
Project Team” or “JPT” has the meaning set forth in Section 3.2(a).
1.94. “Joint
Steering Committee” or “JSC” has the meaning set forth in Section
3.1(a).
1.95. “Knowledge”
means [***].
1.96. “Lead
Product” means either (a) the Existing Product, or (b) a modified version of the
Existing Product created or developed by AstraZeneca, its Affiliates or
Sublicensees in the course of its development activities contemplated in Section
6.3 [***].
1.97. “Legal
Matter” means any dispute regarding the rights or obligations of a Party that
arise out of or relate to the existence, negotiation, validity, formation,
interpretation, breach, performance or application of this Agreement or any
Ancillary Agreement.
1.98. “Licensed
Know-How” means all Information (including any applicable Improvements) that (a)
is Controlled by Nektar or its Affiliates as of the Execution Date or at any
time until the end of the Term, and (b) is necessary or useful for, or is
otherwise directly related to, the Exploitation of the Compounds or the Licensed
Products, but excluding the Excluded Know-How and any Information that is
related exclusively to Nektar’s or its Affiliates’ proprietary compounds other
than the Compounds.
1.99. “Licensed
Patents” means (a) the Licensed Product Patents, or (b) the Nektar Technology
Patents.
1.100. “Licensed
Product Patents” means (a) all the Patents set forth in Schedule 1 or Schedule 2
of Exhibit E of this Agreement and (b) any other Patent(s) that (i) is
Controlled by Nektar or its Affiliates as of the Execution Date or at any time
thereafter until the end of the Term, (ii) has one or more claims that
cover specifically one or more Compounds or Licensed Products, and (iii) is
determined, pursuant to Section 15.1(a)(i), to be a Licensed Product
Patent.
1.101. “Licensed
Product” means any (a) Stand-Alone Product containing NKTR-118, (b) Opioid
Combination Product, (c) Packaged 118 Opioid Product, or (d) Added
Product. When the phrase “each Licensed Product” is used herein,
Licensed Products (including Combination Products) that: (i) are [***], (ii)
have the same [***] and (iii) have the same [***] shall be considered to be
the same Licensed Product.
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1.102. “Losses”
means any and all direct or indirect liabilities, damages, losses or expenses,
including interest, penalties, and reasonable lawyers’ fees and
disbursements.
1.103. “Major
Commercial Market” means [***].
1.104. “Major
European Market” means [***].
1.105. “Manufacture”
and “Manufacturing” means, with respect to a product or compound, the synthesis,
manufacturing, processing, formulating, packaging, labeling, holding and quality
control testing of such product or compound.
1.106. “Manufacture
and Technology Transfer Agreement” or “MTTA” has the meaning set forth in
Section 8.2(b).
1.107. “Manufacturing
Law” has the meaning set forth in Section 8.1(a).
1.108. “[***]”
means any pharmaceutical product that contains as an active ingredient a [***]
that exerts its primary pharmacological activity by binding to a
[***]. The term “[***]” shall not include, with respect to
AstraZeneca, the Licensed Products, or, with respect to Nektar, Reversion
Products in Terminated Countries.
1.109. “NDA
Acceptance Bonus Milestone” has the meaning [***].
1.110. “Nektar
Party” has the meaning set forth in Section 14.1.
1.111. “Nektar
Technology” means all Information that relates to Nektar’s pegylation and other
polymer conjugation platform technology generally, including [***] to a small
molecule. For clarity, the Nektar Technology shall not include any
Information that relates specifically to the Compounds or the Licensed
Products.
1.112. “Nektar
Technology Patents” means any Patents, other than the Licensed Product Patents,
that (a) are Controlled by Nektar or its Affiliates as of the Execution Date or
at any time thereafter until the end of the Term, and (b) claim or cover
Information that is necessary or reasonably useful for the Exploitation of
Compounds or the Licensed Products, but excluding (i) the Excluded Patents and
(ii) any other Patents to the extent relating exclusively to Nektar’s or its
Affiliates’ proprietary compounds other than the Compounds.
1.113. “Nektar
Technology Within LPP Patents” has the meaning set forth in Section
15.1(a)(iii).
1.114. “Net
Sales” means [***].
1.115. “New
Patentable Licensed Know-How” has the meaning set forth in Section
15.1(a)(i).
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1.116. “NKTR-118”
means the compound set forth on Exhibit F of this Agreement.
1.117. “Non-Field
Infringement” has the meaning set forth in Section 16.2(a).
1.118. “Non-Terminated
Country” has the meaning set forth in Section 18.6(b).
1.119. “Offset
Amount” has the meaning set forth in Section 16.7.
1.120. “Opioid
Combination Product” means a product that contains as the sole active
ingredients (a) one or more opiates or opioids (but excluding any such [***], which
[***], in a [***] with (b) NKTR-118, but excluding for clarity all
Packaged 118 Opioid Products.
1.121. “Orange
Book Listable Patent” has the meaning set forth in Section 15.6(a).
1.122. “Other
Publication” means any public publication (including in abstracts, scientific
posters, and other similar public presentations) that is not a Product
Publication and that (a) incorporates, references, or discloses Information with
respect to the Nektar Technology, whether such Information relates to activities
conducted prior to, on, or following the Effective Date and (b) is likely (due
to such publication) to have an adverse effect on the Exploitation of the
Licensed Products; provided, however, that such
public presentation shall not constitute an Other Publication as a result of the
inclusion of Information with respect to which Nektar is bound by obligations of
confidentiality to any Third Party.
1.123. “Packaged
118 Opioid Product” means a product that contains (a) one or more opiates or
opioids (but excluding
any such [***], that is combined in a [***] or other similar packaging
with (b) a Stand-Alone Product containing NKTR-118 in a [***], in the aggregate
as the [***], and where such product is sold at a single invoiced price (that
is, there is not [***] for the components in (a) and (b) above of the
product). Each Packaged 118 Opioid Product shall be a Licensed
Product and shall be treated as a Stand-Alone Product that contains NKTR-118 for
all purposes under this Agreement; provided, however, that
calculations of Net Sales of Packaged 118 Opioid Products for all purposes under
this Agreement, including applicable ceilings and thresholds, shall be subject
to the adjustment in Section 7.3.
1.124. “Party”
means either AstraZeneca or Nektar and “Parties” means both AstraZeneca and
Nektar.
1.125. “Patents”
means (a) all national, regional and international patents and patent
applications, including provisional patent applications, (b) all patent
applications filed either from such patents, patent applications or provisional
applications or from an application claiming priority from either of these,
including divisionals, continuations, continuations-in-part, provisionals,
converted provisionals, and continued prosecution applications, (c) any and all
patents that have issued or in the future issue from the foregoing patent
applications ((a) and (b)), including utility models, xxxxx patents and design
patents and certificates of invention, (d) any and all extensions or
restorations by existing or future extension or restoration mechanisms,
including revalidations, reissues, re-examinations and extensions (including any
supplementary protection certificates and the like) of the foregoing patents or
patent applications ((a), (b) and (c)), and (e) any similar rights, including
so-called pipeline protection, or any importation, revalidation, confirmation or
introduction patent or registration patent or patent of additions to any such
foregoing patent applications and patents.
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1.126. “Patent
Exclusivity List” has the meaning set forth in Section 15.6(b).
1.127. “Patent
Family” means, with respect to a given country, one or more Licensed Product
Patents that claim their priority dates from the same Patent.
1.128. “Patent
Working Group” has the meaning set forth in Section 3.3(b).
1.129. “Payments”
has the meaning set forth in Section 7.17(a).
1.130. “Person”
means an individual, sole proprietorship, partnership, limited partnership,
limited liability partnership, corporation, limited liability company, business
trust, joint stock company, trust, unincorporated association, joint venture or
other similar entity or organization, including a government or political
subdivision, department or agency of a government.
1.131. “Phase
III Clinical Trial” means a pivotal, multi-center, human clinical trial (or set
of trials, if required by a Health Authority) to be conducted in a number of
patients estimated to be sufficient to primarily establish efficacy of a
Licensed Product for the Primary Indication, or any other claimed major medical
indication and at a standard suitable to obtain a Health Registration Approval
in the United States or a Major European Market (excluding dose ranging
studies). A Phase III Clinical Trial shall also include any
well-controlled study (or studies) intended to provide the substantial evidence
of efficacy necessary to support the filing of an approvable Health Registration
Approval (such as a combined Phase II/Phase III study, or any Phase III study in
lieu of a Phase II study), whether or not such study is a traditional Phase III
study. A Phase III Clinical Trial shall be deemed to have commenced
when the first patient is dosed in such Phase III Clinical Trial.
1.132. “Post-Termination
Control Agreements” has the meaning set forth in Section 18.11.
1.133. “Primary
Indication” means prevention or treatment of opioid-induced or opiate-induced
constipation.
1.134. “Product
Publication” means any public publication (including in abstracts, scientific
posters, and other similar public presentations) that incorporates or otherwise
discloses any Information (a) contained in any Regulatory Documentation relating
primarily to a Compound, Licensed Product or Reserved Product, or (b) related
directly to the Exploitation of any Compound, Licensed Product or Reserved
Product, including any study data relating to such products, in each case, ((a)
or (b)), whether such Information relates to activities conducted prior to, on,
or following the Effective Date.
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1.135. “Prohibition
Period” has the meaning set forth in Section 21.5.
1.136. “Prosecute”
has the meaning set forth in Section 15.1(a)(ii).
1.137. “Prosecuting
Party” means the Party having the right to Prosecute the relevant
Patent.
1.138. “Publication”
has the meaning set forth in Section 6.9.
1.139. “Receiving
Party” has the meaning set forth in Section 11.2.
1.140. “Regulatory
Documentation” means all applications, registrations, licenses, authorizations
and approvals, all correspondence submitted to or received from Health
Authorities (including minutes and official contact reports relating to any
communications with any Health Authority) and all supporting documents and all
clinical studies and tests, relating to any Compounds or Licensed Products, and
all data contained in any of the foregoing, including all investigational new
drug applications, Health Registration Approvals, regulatory drug lists,
advertising and promotion documents, adverse event files and complaint
files.
1.141. “Regulatory
Reason” has the meaning set forth in Section 18.4(a).
1.142. “Reserved
Product” means (a) a [***] other than NKTR-118, or (b) a
[***] other than an
Opioid Combination Product.
1.143. “Restricted
Information” has the meaning set forth in Section 11.1.
1.144. “Reversion
Products” means all Licensed Products that contain (a) NKTR-118 as the sole
active ingredient, or (b) NKTR-118 and one or more generic opioids or opiates,
as the sole active ingredients; and excluding (for clarity) any other Licensed
Products.
1.145. “Review
Period” has the meaning set forth in Section 18.4(a).
1.146. “ROW”
means all countries in the Territory other than the United States.
1.147. “Safety
Agreement” has the meaning set forth in Section 10.1.
1.148. “Safety
Reasons” has the meaning set forth in Section 18.4(a).
1.149. “Second
Enforcing Party” has the meaning set forth in Section 16.3.
1.150. “Stand-Alone
Product” means any product in a form suitable for human, veterinary or
agricultural applications that contains a Compound as the sole active
ingredient.
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1.151. “Standard
Sales Price” shall mean, with respect to a product and a country, the
wholesale acquisition cost (in the case of product sold in the United States) or
the ex-manufacturing price (in the case of product sold outside the United
States), as such terms are commonly understood in the pharmaceutical industry,
for such product in such country, where such price is the price at which product
is sold to wholesalers or other direct customers in such country before giving
effect to any prompt payment or other discounts.
1.152. “Statement”
has the meaning set forth in Section 18.4(a).
1.153. “Subject
Party” has the meaning set forth in Section 21.4.
1.154. “Sublicensee”
has the meaning set forth in Section 4.2.
1.155. “Sublicense
Income” has the meaning set forth in Section 7.6(c).
1.156. “Substitute
Compound” has the meaning set forth in Section 7.10(b).
1.157. “Target
Product Profile” means the actual “target product profile” for the Existing
Product as set forth in the Development Plan, as provided in Section
6.2.
1.158. “Term”
has the meaning set forth in Section 18.2.
1.159. “Terminated
Country” has the meaning set forth in Section 18.6(b).
1.160. “Termination
Notice” has the meaning set forth in Section 18.5(a).
1.161. “Territory”
means all countries in the world, excluding all Terminated
Countries.
1.162. “Third
Party” means any Person not including the Parties, the Parties’ respective
Affiliates or Sublicensees.
1.163. “Third
Party Claim” has the meaning set forth in Section 14.1.
1.164. “Third
Party Infringing Activities” has the meaning set forth in Section
16.1.
1.165. “TPP
Reason” has the meaning set forth in Section 18.4(a).
1.166. “Trademark”
means any word, name, symbol, color, designation or device or any combination
thereof for use in the course of trade, including any domain name, trademark,
trade dress, brand xxxx, trade name, brand name, logo or business symbol used by
AstraZeneca in connection with the Compounds or Licensed Products.
1.167. “Transition
Agreement” has the meaning set forth in Section 18.12.
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1.168. “United
States” or “U.S.” means the United States of America, including its territories,
possessions and Puerto Rico.
1.169.
“Valid Claim” means, with respect to a Licensed Product in a particular country,
any claim of a Licensed Patent that specifically or generically claims (x) the
Compound included in such Licensed Product as a composition of matter, or (y) a
method of treatment or other use of a Compound for one or more indications for
which Health Registration Approval has been received for a Licensed Product in
such country, and either:
(a) with
respect to a granted and unexpired Licensed Patent in such country, that (i) has
not been held permanently revoked, unenforceable or invalid by a final decision
of a court or other governmental agency of competent jurisdiction, which
decision is unappealable or unappealed within the time allowed for appeal, and
(ii) has not been abandoned, disclaimed, denied or admitted to be invalid or
unenforceable through reissue or disclaimer or otherwise; or
(b) with
respect to a pending Licensed Patent application, that was filed and is being
prosecuted in good faith and has not been [***] without the possibility of [***]
of the application, provided that such
claim [***] for more than [***] years.
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2.
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Construction
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Except
where the context requires otherwise, whenever used the singular includes the
plural, the plural includes the singular, the use of any gender is applicable to
all genders and the word “or” has the inclusive meaning represented by the
phrase “and/or”. Whenever this Agreement refers to a number of days,
unless otherwise specified, such number refers to calendar days. The
headings of this Agreement are for convenience of reference only and do not
define, describe, extend or limit the scope or intent of this Agreement or the
scope or intent of any provision contained in this Agreement. The
term “including” or “includes” as used in this Agreement means “including
without limitation” and shall not be interpreted to limit the generality of any
description preceding such term. The wording of this Agreement shall
be deemed to be the wording mutually chosen by the Parties and no rule of strict
construction shall be applied against any Party.
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3.
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Governance.
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3.1. Joint Steering
Committee.
(a) Formation and
Responsibilities. As of the Effective Date, the Parties have
established a joint steering committee (the “Joint Steering Committee” or
“JSC”), which shall have
the following responsibilities: (i) overseeing at a high level the
work of the JPT, and periodically receiving reports and other information
submitted by the JPT; (ii) resolving all disputes referred to the JSC by the
JPT; and (iii) making such other decisions as may be delegated to the JSC
pursuant to this Agreement or by written agreement of the
Parties.
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(b) Membership. Each
Party shall designate, in its sole discretion, [***] employees to serve as
members of the JSC, each with the requisite experience and seniority to make
decisions on behalf of the Parties with respect to issues falling within the
jurisdiction of the JSC. No member of the JSC may also serve on the
JPT. Nektar and AstraZeneca shall designate their respective initial
members of the JSC within [***] after the Effective Date. Each Party
may invite non-voting representatives (up to [***] non-voting representatives)
to attend JSC meetings; provided that such
Party provides advance notice to the other Party of such
attendance.
(c) Decision-Making and Dispute
Resolution. The members of the JSC shall use reasonable
efforts to reach agreement on all matters. If, despite such efforts,
agreement on a particular matter cannot be reached by the JSC within [***] after
the JSC first considers such matter (or such shorter time as may be reasonable
in the circumstances), then the chair of the JSC shall have the right to make
the final decision with regard to the disputed matter following good faith
consideration of Nektar’s comments. Notwithstanding the
foregoing:
(i) disputes
regarding whether AstraZeneca’s efforts to meet its diligence obligations with
respect to development, regulatory or commercial matters constitute Commercially
Reasonable Efforts shall not be subject to the foregoing decision-making and
shall be resolved pursuant to the procedures set forth in Section
18.5(b);
(ii)
disputes arising out of matters within the jurisdiction of the Patent Working
Group shall be resolved pursuant to the procedures set forth in Article
15;
(iii) disputes
regarding the interpretation or an alleged breach of this Agreement (other than
any dispute described in clause (i)) shall be resolved pursuant to expedited
arbitration pursuant to Section 19.3;
(iv) the
JSC, and the chair of the JSC, shall not have any authority to amend, modify or
waive the provisions of this Agreement; and
(v) no
final decision by the chair of the JSC without the consent of Nektar or Nektar’s
representative on the JSC shall be made that has the effect of materially
increasing the obligations of Nektar or of reducing Nektar’s rights under this
Agreement or any Ancillary Agreement.
3.2. Joint Project
Team.
(a) Formation and
Responsibilities. As of the Effective Date, the Parties have
established a joint project team (the “Joint Project Team” or “JPT”), which (x) shall
oversee, coordinate and expedite the development of the Licensed Products in the
Territory and the submission of applications for Health Registration Approvals
and other regulatory submissions for Licensed Products in the Territory and
shall facilitate the flow of information with respect to development activities
being conducted for the Licensed Products and clinical studies in support of
Health Registration Approvals for the Licensed Products in the Territory; and
(y) shall serve as a forum for facilitating the flow of information with
respect to commercialization of Licensed Products in the
Territory. Specifically, the JPT shall have the following
responsibilities:
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(i) reviewing
and adopting the Development Plan and updates and amendments
thereto;
(ii) reviewing
data, reports or other information submitted by AstraZeneca with respect to
development activities conducted by or on behalf of AstraZeneca pursuant to
Section 6.8 or otherwise, and discussing such data, reports and other
information and reviewing the overall progress of Licensed Product development
by or on behalf of AstraZeneca (or its Affiliates or Sublicensees);
(iii) facilitating
the exchange of information and data between the Parties with respect to the
commercialization of Licensed Product in the Territory (as expressly required
under other terms of this Agreement), and conducting high-level discussion of
such exchanged information and data;
(iv) making
such other decisions as may be delegated to the JPT pursuant to this Agreement
or by written agreement of the Parties;
(v)
establishing and overseeing the Patent Working Group pursuant to
Section 3.3(b); and
(vi) establishing
other working groups to implement the foregoing responsibilities, which working
groups shall have such responsibilities, and be comprised of such number of
employees from each of the Parties with such expertise and seniority, as the JPT
may direct from time to time, supervising and directing the activities of such
working groups and accepting reports and recommendations from such working
groups.
(b) Membership. Each
Party shall designate, in its sole discretion, such number of employees as it
reasonably determines (which number shall be at least [***] and no more than
[***]), each with the requisite experience and seniority to make decisions on
behalf of the Parties with respect to issues falling within the jurisdiction of
the JPT. Nektar and AstraZeneca shall designate their respective
initial members of the JPT within [***] after the Effective Date.
(c) Decision-Making and Dispute
Resolution. The members of the JPT shall use reasonable
efforts to reach agreement on all matters. If, despite such efforts,
agreement on a particular matter within the jurisdiction of the JPT cannot be
reached by the JPT within [***] after the JPT first considers such matter (or
such shorter period as may be reasonable in the circumstances), then (i) if the
matter is a material one, the JPT shall refer the disputed matter to the JSC for
resolution, or (ii) if the matter is not a material one, the chair of the JPT
shall have the right to make the final decision with regard to the disputed
matter following good faith consideration of Nektar’s comments. The
JPT shall not have any authority to amend, modify or waive the provisions of
this Agreement.
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3.3. Working
Groups
(a) In
General. The JPT may delegate specific matters or types of
matters within its jurisdiction to working groups, the composition of which
shall be determined by the JPT; provided, however, that unless
the Parties otherwise agree, each working group shall include (unless otherwise
agreed by the JPT) [***] representatives from each Party. Each
working group shall operate pursuant to procedures to be defined by the JPT in
establishing such working group. Each working group shall make
recommendations to the JPT with respect to the matters delegated to such working
group, and shall use reasonable efforts to have such recommendations reflect
consensus of the Parties whenever possible.
(b) Patent Working
Group. Within [***] after the Effective Date, the Parties
shall cause their respective members on the JPT to establish a working group to
coordinate and direct, in accordance with Article 15, the Prosecution of
Licensed Patents and Joint Patents (the “Patent Working Group”), which
working group shall include [***] internal patent counsel representing each
Party, and shall include such additional representatives of each Party with
appropriate expertise and authority as reasonably required for the Patent
Working Group to conduct its role and exercise its authority efficiently and
effectively.
3.4. General Provisions Governing
Committees. The following general provisions shall govern the
conduct of the JSC, JPT and any working groups the JSC or JPT may establish from
time to time under this Agreement (each, including the JSC and the JPT, a “Committee”), except as
otherwise expressly provided elsewhere in this Agreement or as agreed to by the
Parties in writing:
(a) Chair;
Membership. One of AstraZeneca’s representatives shall be
designated by AstraZeneca as the chair of each Committee. Each Party
shall have the right at any time to substitute qualified individuals, on a
permanent or temporary basis, for any of its previously designated
representatives to each Committee, by giving written notice to the other
Party.
(b) Meetings.
(i) Schedule of Meetings;
Agenda. Each Committee shall establish a schedule of times for
regular meetings. In addition, the chair of each Committee may
convene a special meeting of the Committee with at least [***] written or email
notice to the members of the Committee if such meeting is to be conducted in
person (and if Nektar reasonably objects to such date due to a conflicting
obligation, the chair will make good faith efforts to offer another date that
will accommodate Nektar’s schedule, but in no event shall the chair be obligated
to delay such meeting for more than [***] additional [***]), and with at least
[***] written or email notice if such meeting is to be conducted by
teleconference, and shall prepare and circulate to each Committee member an
agenda for each meeting not later than [***] prior to such
meeting. Notwithstanding the foregoing, (A) notice of any such
special meeting or receipt of such agenda may be waived in writing at any time,
either before, during or after such meeting, and (B) attendance of any
member at a meeting shall constitute a valid waiver of notice of any such
special meeting or receipt of such agenda from such member, unless such member
attends the meeting for the express purpose of objecting to the failure to
provide valid notice or an agenda. Regular and special meetings of
the Committee may be held in person or by teleconference or
videoconference. The chair of the Committee shall determine the
location of each regular and special meeting; provided that the
location of meetings to be held in person shall alternate between sites
designated by each Party.
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(ii) Quorum; Voting;
Decisions. A Committee shall have the right to adopt such
standing rules as shall be necessary for its work to the extent that such rules
are not inconsistent with this Agreement. A quorum of a Committee
shall exist whenever there is present at a meeting at least [***] appointed by
each Party. Members of a Committee may attend a meeting either in
person or by telephone, video conference or similar means in which each
participant can hear what is said by, and be heard by, the other participants
(with any written presentations by either Party provided by electronic means in
advance of or simultaneously with such meeting to the participants of the other
Party). Representation by proxy shall be allowed. A
Committee shall take action by consensus of the members present at a meeting at
which a quorum exists, with, subject to the final decision-making authority of
the chair of the JSC and the JPT, respectively, as set forth in Section 3.1(c)
and Section 3.2(c), each Party having [***] irrespective of the number of
representatives of such Party in attendance or by a written resolution signed by
at least [***] appointed by each Party. Reasonable numbers of
employees of either Party that are not members of a Committee may attend any
meeting of such Committee; provided, however, that such
attendees (A) shall not vote or otherwise participate in the
decision-making process of such Committee and (B) are bound by obligations
of confidentiality and non-disclosure equivalent to those set forth in Article
11.
(iii) Minutes. Each
Committee shall keep minutes of its meetings that record in reasonable detail
all decisions and all actions recommended or taken. Drafts of the
minutes shall be prepared and circulated to Committee members promptly after the
meeting, and the Parties shall alternate responsibility for the preparation and
circulation of the draft minutes. Each Committee member shall have
the opportunity to provide comments on the draft minutes, which comments shall
be provided to all Committee members as soon as practicable after circulation of
the draft minutes. The minutes shall be deemed approved upon the
approval of such minutes by at least [***] appointed by each Party, provided that minutes
for such meeting may reflect a lack of consensus on an issue-by-issue basis, the
person(s) responsible for resolving such matter and by what date such matter
shall be resolved. Upon approval, final minutes shall be circulated
to the members of the Committee by the chair.
(iv) Expenses. Each
Party shall bear all costs of its representatives on a Committee related to
their participation on the Committee and attendance at Committee
meetings.
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(c) Limitations on
Authority. Each Party shall retain the rights, powers and
discretion granted to it under this Agreement and no such rights, powers, or
discretion shall be delegated to or vested in a Committee unless such delegation
or vesting of rights is expressly provided for in this Agreement or the Parties
expressly so agree in writing. No committee shall have the power to
amend, modify or waive compliance with this Agreement.
(d) Interactions Between
Committees and Internal Teams. The Parties recognize that each
Party possesses an internal structure (including various committees, teams and
review boards) that will be involved in administering such Party’s activities
under this Agreement. Each Committee shall establish procedures to
facilitate communications between such Committee and the relevant internal
committee, team or board of each of the Parties in order to maximize the
efficiency of such Committee and the performance of the Parties of their
obligations under this Agreement, including by requiring appropriate members of
such Committee to be available at reasonable times and places and upon
reasonable prior notice for making appropriate oral reports to, and responding
to reasonable inquiries from, the relevant internal committee, team or
board.
(e) Nektar’s Membership in
Committees. Nektar’s membership in any Committee shall be
[***], for the sole purpose of participation in governance, decision-making, and
information exchange with respect to activities within the jurisdiction of such
Committee. [***] in any or all of the Committees [***] prior written
notice to AstraZeneca, which notice shall be effective as to the relevant
Committee upon the expiration of such [***] period (and for the avoidance of
doubt, following such [***], Nektar and AstraZeneca shall each continue to be
required to perform its respective obligations pursuant to this
Agreement). Following the issuance of such notice for a given Committee,
(i) Nektar’s membership in such Committee shall be [***] (and AstraZeneca may
[***] such Committee), (ii) Nektar shall not have the right to [***] therein,
and (iii) Nektar shall have the right to continue to [***] it would otherwise be
entitled to receive under the Agreement.
(i) [***] of
JSC. If the JSC is [***] pursuant to this Section 3.4(e) or
Section 21.3, then any dispute that would have been elevated to the JSC for
resolution shall be elevated directly to the Executives for resolution pursuant
to Section 19.1, and if such executives are unable to resolve the dispute,
AstraZeneca’s executive officer shall have the right to make the final decision
with regard to such disputed matter; provided, however, that
AstraZeneca’s executive officer shall make such decision in good faith after
reasonably considering Nektar’s comments on such matter and in a manner
consistent with the applicable then-current Development Plan. For the
avoidance of doubt, disputes regarding whether AstraZeneca’s efforts meet its
development diligence obligations shall be resolved pursuant to the procedures
set forth in Section 18.5(b).
(ii) [***] of
JPT. If the JPT is [***] pursuant to this Section 3.4(e) or
Section 21.3, then any dispute that would have been considered by the JPT shall
be elevated directly to the JSC and the information that each Party is obligated
to provide to the JPT pursuant to Section 6.8 shall be provided directly to the
other Party.
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4.
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Grant
of Rights
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4.1. License Grants to
AstraZeneca. Subject to the terms and conditions of this
Agreement, Nektar hereby grants to AstraZeneca:
(a) an
exclusive (including with regard to Nektar and its Affiliates), perpetual
(subject to termination under the terms of this Agreement), right and license in
the Territory, with the right to grant sublicenses pursuant to Section 4.2,
under Nektar’s and its Affiliates’ rights, titles, and interests in and to the
Licensed Patents, the Licensed Know-How, the Joint Patents and the Joint
Know-How solely to Exploit the Compounds and Licensed Products for all purposes;
provided, however, that Nektar
shall retain, subject to Article 9, the non-exclusive right solely to perform
its responsibilities under this Agreement or any Ancillary
Agreement.
(b) an
exclusive (including with regard to Nektar and its Affiliates), perpetual
(subject to termination under the terms of this Agreement), right and license
and right of reference in the Territory, with the right to grant sublicenses
pursuant to Section 4.2, under Nektar’s and its Affiliates’ rights, titles and
interests in and to the Regulatory Documentation and the Health Registration
Approvals, to the extent not assigned pursuant to Section 4.9, to Exploit the
Compounds and Licensed Products for all purposes; provided, however, that Nektar
shall retain, subject to Article 9, the non-exclusive right solely to perform
its responsibilities under this Agreement or any Ancillary
Agreement.
(c) an
exclusive (including with regard to Nektar and its Affiliates), perpetual
(subject to termination under the terms of this Agreement), right and license in
the Territory, without the right to grant sublicenses, under Nektar’s and its
Affiliates’ rights, titles, and interests in and to the Licensed Patents, the
Licensed Know-How, the Joint Patents and the Joint Know-How solely to Exploit
the Reserved Products (including the Compound(s) therein) for all
purposes.
4.2. Sublicenses. AstraZeneca
shall have the right to grant sublicenses, through multiple tiers of
sublicensees, under the licenses granted in Section 4.1(a) and (b), to its
Affiliates and to any other Person. Where AstraZeneca grants a
sublicense to a Person that is not an Affiliate of AstraZeneca, and such Person
is not a Distributor or a Third Party to which AstraZeneca or its Affiliates
grants sublicense to sell Generic Products by AstraZeneca, such Person shall be
a “Sublicensee” for
purposes of this Agreement. In the event AstraZeneca desires to grant
a sublicense in the [***] or any country within a [***], AstraZeneca shall
conduct such sublicensing efforts using such efforts and resources that are
typically used by AstraZeneca, and consistent with its typical standards, in
connection with evaluating and negotiating sublicensing transactions for its own
compounds or products with similar commercial potential at a similar stage in
their lifecycle. AstraZeneca shall ensure that all Persons to which
it grants sublicenses comply with all applicable terms and conditions of this
Agreement, and AstraZeneca shall be responsible for any failure of any such
sublicensee to comply with such terms or conditions, with the further
understanding that any action or omission by any such sublicensee that, if
committed by AstraZeneca would be a breach of this Agreement (with respect to
those country(ies) in which such sublicensee is sublicensed), will be deemed a
breach by AstraZeneca of this Agreement (with respect to those country(ies) in
which such sublicensee is sublicensed) for which AstraZeneca is
responsible.
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4.3. Distributorships. AstraZeneca
and its Affiliates shall have the right, in their sole discretion, to appoint
any other Persons, in the Territory or in any country of the Territory, to
distribute, market and sell the Licensed Products, including Authorized Generic
Versions, (with or without packaging rights, but excluding in any case any
rights to make Licensed Product), solely in circumstances where the Person
purchases its entire requirements of Licensed Products from AstraZeneca or its
Affiliates, but does not otherwise make any royalty or other payment to
AstraZeneca with respect to its intellectual property rights. Where
AstraZeneca or its Affiliates appoints such a Person in compliance with the
foregoing and such Person is not an Affiliate of AstraZeneca, that Person shall
be a “Distributor” for
purposes of this Agreement. For clarity, AstraZeneca and any of its
Affiliates shall have the right, in its sole discretion, to appoint one of its
Affiliates to distribute, market and sell the Licensed Products in the
Territory, but any Affiliates so appointed shall not be included in the term
“Distributor” for
purposes of this Agreement. The term “packaging rights” in this
Section 4.3 means the right for the Distributor to package Licensed Products
supplied in unpackaged bulk form into individual ready-for-sale
packs. For clarity, any and all amounts paid by any Distributor to
AstraZeneca or its Affiliate for such distribution appointment with respect to
the Licensed Product and the sale of the Licensed Products to the Distributor
shall be deemed to be included in the calculation of Net Sales.
4.4. Co-Promotion
Rights. For the avoidance of doubt, AstraZeneca and its
Affiliates shall have the right, in their sole discretion, to co-promote the
Licensed Products with any other Person(s), or to appoint one or more Third
Parties to promote the Licensed Products without AstraZeneca in all or any part
of the Territory. Nothing in this Section 4.4 shall be construed to
modify the definition of Distributor or Sublicensee, and it is understood and
agreed that any such Third Party that promotes or co-promotes Licensed Products
may also be a Distributor or Sublicensee, as the case may be, if such definition
is satisfied.
4.5. Covenants
(a) Patent
Filings. To the extent Applicable Law permits Nektar to
conduct research and development activities with respect to Compounds, Licensed
Products or Reserved Products notwithstanding the exclusive licenses grants to
AstraZeneca under Section 4.1, Nektar agrees that neither it nor its Affiliates
shall file any Patent applications based on any inventions conceived or reduced
to practice in connection with such research and development activities without
the prior written consent of AstraZeneca. Nothing contained in this
Section 4.5(a) is in derogation of any provision of Section
4.5(c).
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(b) Covenants of
AstraZeneca. AstraZeneca covenants and agrees that it and its
Affiliates and Sublicensees shall not [***].
(c) Non-Compete. During
the period prior to the [***] of the earlier to occur of (x) [***] of the first
Licensed Product in the [***] or (y) the First Commercial Sale [***], each Party
covenants that it and its Affiliates shall not:
(i) conduct
any [***] of a [***] for any [***], or market or sell any [***] labeled for use
in any [***] (each such product, a “Competing Product”); provided that the
foregoing shall not be interpreted to prevent the [***] for use in an [***]
other than a [***], whether or not such [***] includes one or more [***] (as
such terms is defined below);
(ii) conduct
any [***] of a [***] for an [***] other than the [***] with a [***] that
includes as an [***] any [***], provided that the foregoing shall not
prevent the Party from [***] that the [***] or the [***] requires or directs be
collected, or that the Party reasonably believes would be required, in order to
[***] the [***] with, or obtain [***] for, [***] for an [***] other than a
[***];
(iii) affirmatively
use any [***] in marketing or promoting a [***] (except to the extent required
by Applicable Law);
(iv) conduct
any activity with, for the benefit of, or sponsored by, any Third Party, which
activity would constitute a violation of clauses (i), (ii) or (iii) if it were
conducted by such Party solely on its own behalf; or
(v) knowingly
grant any license or other rights to any Third Party to utilize any intellectual
property Controlled by such Party or its Affiliates (including any Licensed
Patents, Licensed Know-How, Joint Patents or Joint Know-How) for the express
purpose of enabling such Third Party to conduct an activity which would
constitute a violation of clauses (i), (ii) or (iii) if it were conducted by
such Party solely on its own behalf;
(vi) provided, however, that in no
event shall a Party or its Affiliates be restricted under this Section 4.5(c)
from using a [***] (other than, in the case of Nektar, the Licensed Products or
the Reserved Products) as a [***] of a product that is not a Competing Product,
even if such [***] is for the [***] or would require the collection of
[***].
The
Parties acknowledge that all restrictions contained in this Section 4.5(c) are
reasonable, valid and necessary for the adequate protection of the Licensed
Product business and that the Parties would not have entered into this Agreement
without the protection afforded to them by this Section 4.5(c).
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(d) No Conflicting Grant of
Rights. Nektar shall not, and shall cause its Affiliates not
to, assign or transfer any of its rights, title or interests in or to the
Licensed Patents, Licensed Know-How, Joint Patents, Joint Know-How or Health
Registration Approvals to any Third Party, except to a Person that is an
assignee of Nektar of this Agreement pursuant to an assignment permitted under
Section 21.1. Nektar shall not, and shall cause its Affiliates not
to, grant any license or other rights or interests in the Licensed Patents,
Licensed Know-How, Joint Patents, Joint Know-How or Health Registration
Approvals to any Person that are within the scope of the licenses granted to
AstraZeneca under Section 4.1 of this Agreement.
4.6. Right of First
Negotiation. Prior to out-licensing or selling, assigning or
transferring the results of any research or pre-clinical development conducted,
by or on behalf of Nektar during the term of the non-compete covenant in Section
4.5(c), with respect to Competing Products other than Licensed Products or
Reserved Products (or any Intellectual Property Rights with respect to such
results) (collectively, the “Competing Product IP”), Nektar
shall notify AstraZeneca in writing and AstraZeneca shall have [***] in which to
respond and, if applicable, [***]. Provided that Nektar has given
AstraZeneca such notice, Nektar may [***] regarding the terms of a possible
agreement regarding such Competing Product IP to Exploit such Competing
Products, provided that Nektar
shall not enter into any such agreement except as provided in the following
sentence. If either (a) AstraZeneca does not respond to Nektar’s
notice with an intention of interest within the [***] or (b) the Parties are
unable to execute a definitive agreement [***], then, provided that in each
case ((a) and (b)) the non-compete covenant in Section 4.5(c) either does not
cover the rights being licensed or is no longer applicable, Nektar shall
thereafter be free to enter into such an agreement with a Third
Party. For clarity, nothing in the foregoing prevents Nektar (or its
Affiliate) from negotiating and granting licenses under its Competing Product IP
for uses other than
with respect to a Competing Product, Reserved Product, Compound or
Licensed Product.
4.7. Exclusivity
Term. The exclusive nature of AstraZeneca’s license rights
granted by Section 4.1 shall expire with respect to each separate Licensed
Product, on a country-by-country basis, on the date when AstraZeneca’s
obligation to pay royalties with respect to such Licensed Product pursuant to
Section 7.9 expires in the applicable country. Upon such expiry of
the exclusivity of AstraZeneca’s license rights with respect to a Licensed
Product in a country, AstraZeneca’s license rights with respect to such Licensed
Product in such country shall become non-exclusive, fully paid-up, perpetual and
irrevocable, and the Net Sales of such Licensed Product in such country shall be
excluded from the royalty calculations in Sections 7.2, 7.4, 7.5 and 7.10(b)
(including the thresholds and ceilings) and the milestones in Section 7.1 that
are based on Annual Net Sales. AstraZeneca and its Affiliates and
Sublicensees shall be allowed to continue Exploiting such Licensed Product and
using all Licensed Know-How and Joint Know-How in connection therewith on a
non-exclusive basis in such country with no further consideration to Nektar with
respect to such activities. Upon expiration of such exclusivity with
respect to all Licensed Products then being commercialized in the applicable
country, all the license rights granted to AstraZeneca shall automatically
become non-exclusive, fully-paid, perpetual licenses rights in such country, and
all license exclusivity under Section 4.1 shall terminate except that for any Licensed
Product that is in active human clinical development by AstraZeneca or its
Affiliate at the time of such expiration, such license exclusivity shall
continue for so long as AstraZeneca or its Affiliate continues in good faith to
actively develop or commercialize such Licensed Product.
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4.8. License Limitations;
Retained Rights. AstraZeneca and its Affiliates and
Sublicensees shall not intentionally use or practice any Licensed Know-How or
Licensed Patents in a manner that would constitute misappropriate or
infringement thereof, except to the extent permitted under the license rights
expressly granted under Section 4.1 of this Agreement. Without
limiting the foregoing, AstraZeneca and its Affiliates and Sublicensees shall
not intentionally use or practice any Licensed Know-How or Licensed Patents,
knowing that such use or practice would constitute misappropriate or
infringement thereof, to discover, research, develop, make, use or sell any
pegylated or other polymer conjugated compound other than a Compound or Licensed
Product. Notwithstanding the foregoing two sentences, the covenants
therein shall not apply to MedImmune, LLC, MedImmune Limited or any direct or
indirect subsidiaries of MedImmune, LLC or MedImmune
Limited. Notwithstanding the rights granted to AstraZeneca in Section
4.1, Nektar and its Affiliates retain the exclusive rights under all their
respective technology and Intellectual Property Rights to conduct discovery,
research, clinical trials and other development, to manufacture and use, and to
promote, market, offer for sale and sell all pegylated or other polymer
conjugated compounds other than Compounds, and to license Third Parties to do
the same, throughout the world, but subject to the restrictions in Section
4.5(c).
4.9. Assignment of Regulatory
Documentation. Nektar hereby assigns to AstraZeneca all of its
rights, titles and interests in and to all Regulatory Documentation, including,
to the extent permitted by Applicable Law, all Health Registration Approvals,
owned or Controlled by Nektar as of the Effective Date and from time to time
during the Term. Nektar shall duly execute and deliver, or cause to
be duly executed and delivered, such instruments and shall do and cause to be
done such acts and things, including the filing of such assignments, agreements,
documents and instruments, as may be necessary under, or as AstraZeneca may
reasonably request in connection with, or to carry out more effectively the
purpose of, or to better assure and confirm unto AstraZeneca its rights under,
this Section 4.9.
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5.
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Confirmatory
Patent Licenses
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Nektar
shall if reasonably requested to do so by AstraZeneca promptly enter into
confirmatory license agreements in the form or substantially the form set out in
Exhibit C for purposes of recording the licenses granted under this Agreement
with such Patent Offices in the Territory as AstraZeneca considers reasonably
necessary, including to avoid disclosure of this Agreement. As
between the Parties, regardless of whether any required confirmatory licenses
are executed, the Parties’ respective rights and obligations in respect of the
Licensed Patents shall be as set forth under this Agreement.
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6.
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Development
and Commercialization.
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6.1. Ongoing
Development. As of the Effective Date, Nektar has conducted or
is conducting certain clinical studies for the Existing Product. The
Parties acknowledge and agree that additional development will be required to
obtain Health Registration Approval for the Existing Product for the Primary
Indication in the Territory.
6.2. Development
Plan. The Parties agree that AstraZeneca shall prepare and
finalize, in consultation and discussion with the JPT, its actual development
plan governing the development of the Existing Product for the Primary
Indication, and the filing of Regulatory Documentation (including Health
Registration Approvals) in connection therewith (the “Development Plan”), no later
than [***]. Such initial Development Plan shall reflect AstraZeneca’s
good faith plan of the activities required to develop the Existing Product for
the Primary Indication in a manner that is consistent with its diligence
obligations hereunder. The Development Plan shall include a Target
Product Profile developed by AstraZeneca in good faith. AstraZeneca
may but shall not be required to modify the Development Plan with respect to the
development of the Existing Product or other Licensed Products in one or more
countries from time to time, and shall discuss such proposed modifications with
the JPT. From time to time, either Party may propose to the JPT for
review any proposed amendments to the Development Plan. Nektar
shall have the right and opportunity to review and comment upon all proposed
updates or amendments to the Development Plan through its representatives on the
JPT (and the JSC, as applicable).
6.3. AstraZeneca
Development. Except as otherwise expressly provided in any
Ancillary Agreement, AstraZeneca shall have the sole right and (subject to
Section 6.4) responsibility, at its sole expense (which, for clarity, shall not
include any costs incurred by Nektar prior to the Effective Date), to develop
the Compounds and the Licensed Products and (subject to the other applicable
terms of this Agreement) the Reserved Products. Whether or not
AstraZeneca elects to modify the Development Plan, AstraZeneca shall keep Nektar
reasonably apprised of its anticipated development activities through Nektar’s
representatives on the JPT (and the JSC, as applicable) as set forth in Section
6.8. AstraZeneca covenants that it shall use Commercially Reasonable
Efforts to conduct and complete the development activities contained in the
initial Development Plan (the “Initial Phase III Program”),
as such program may be modified by AstraZeneca in its reports to the JPT
pursuant to Section 6.8, subject only to the following provisions of this
Section 6.3. The Parties anticipate that [***] required to obtain FDA
approval of the Lead Product for the Primary
Indication. Notwithstanding the foregoing, it is understood
that: (a) AstraZeneca may discontinue immediately all or part of
the Initial Phase III Program, including any clinical trial included therein, at
any time for any Safety Reason, TPP Reason or Regulatory Reason, and
(b) AstraZeneca may modify the Initial Phase III Program from time to time
as it deems appropriate, in good faith, in the interest of securing FDA approval
for the Lead Product for the Primary Indication for the United States or other
Health Registration Approvals, which modifications shall be discussed with the
JPT as provided in Sections 3.2(a) and 6.8. The Parties acknowledge
that any timelines or estimates with respect to timing included in the
Development Plan are for informational purposes only.
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6.4. Diligence
Obligations.
(a) Development
Diligence. AstraZeneca shall use Commercially Reasonable
Efforts at its own cost and expense to develop the Lead Product and an Opioid
Combination Product as necessary to obtain, and to seek to obtain, Health
Registration Approvals therefor for use in humans in the Territory for the
Primary Indication.
(b) Commercialization. AstraZeneca
shall use Commercially Reasonable Efforts to promote, market, sell and otherwise
commercialize Licensed Products for use in humans in the Territory for
indications for which AstraZeneca (or its Affiliate or Sublicensee) has obtained
Health Registration Approval for such Licensed Products.
It is
expressly agreed that, to the extent that failure by Nektar (or, if applicable,
its Affiliate) to perform its respective obligations under this Agreement or any
Ancillary Agreement, including the information disclosure requirements pursuant
to Section 6.10 or the supply of Licensed Product pursuant to Article 8, impedes
or prevents AstraZeneca’s ability to conduct specific development or
commercialization activities with respect to the applicable Licensed Product,
then AstraZeneca shall not be deemed in breach of its obligations under Section
6.4(a) or (b) or Section 6.3 (as applicable) with respect to the Initial Phase
III Program due to AstraZeneca’s inability to conduct such specific activities,
so long as AstraZeneca otherwise continues to use Commercially Reasonable
Efforts to proceed with development and (if applicable) commercialization of the
applicable Licensed Products to the extent it is able to do so (notwithstanding
such failure by Nektar (or its Affiliate)). Further, the Parties
acknowledge and agree that nothing in Section 6.4(a) or Section 6.3 (as
applicable) is intended, or shall be construed, to require AstraZeneca to
develop any specific Licensed Product other than the Lead Product
and at least one Opioid Combination Product. Other than its
obligations set forth in Section 6.3 and this Section 6.4, AstraZeneca shall
have no other obligation, express or implied, to Exploit the Licensed
Products.
6.5. Development by
Nektar. If AstraZeneca desires Nektar to perform any
development activities with respect to the Licensed Products, AstraZeneca shall
notify Nektar in writing of the specific activities requested, and the Parties
then shall negotiate reasonably and in good faith a development agreement
pursuant to which Nektar would undertake and be responsible for conducting such
development activities (as set forth in such agreement), subject to
reimbursement by AstraZeneca at Nektar’s then-current rates (any such agreement,
a “Development
Agreement”). It is understood that, other than the obligation
to transfer the Licensed Know-How and provide AstraZeneca with reasonable
assistance with respect thereto pursuant to Section 6.10, Nektar has no
obligation to conduct any development activities with respect to Licensed
Products except pursuant to the terms of an agreed and executed Development
Agreement, and further that Nektar is not obligated to enter into any such
Development Agreement except on commercially reasonable terms acceptable to
Nektar that do not materially impede or interfere with its other business
activities and commitments.
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6.6. Acknowledgment Regarding
AstraZeneca’s Other Business Activities. Nektar acknowledges
that AstraZeneca is in the business of researching, developing, manufacturing
and selling small molecule, macromolecule and biologics products and, except as set forth in
Section 4.5(c), nothing in this Agreement shall be construed as restricting such
business or imposing on AstraZeneca a duty to market or sell and exploit the
Licensed Products to the exclusion of, or in preference to, any other product or
process, or in any way other than in accordance with its normal commercial
practices and that of its Affiliates, provided that
AstraZeneca in doing so complies with its obligations to use Commercially
Reasonable Efforts to develop and commercialize Licensed Products as provided in
Section 6.3 and Section 6.4 (as applicable).
6.7. Regulatory
Matters.
(a) In
General. AstraZeneca shall have the sole right and (subject to
Section 6.4) responsibility, at its sole expense, to submit all applications for
Health Registration Approval and make all other submissions with Health
Authorities and to otherwise seek all Health Registration Approvals for Licensed
Products in the Territory, as well as to conduct all correspondence and
communications with Health Authorities regarding such
matters. Without limitation of the reporting requirements in Section
6.8, AstraZeneca shall keep Nektar reasonably informed of submissions for Health
Registration Approval in the [***], or to the [***] or in any [***] and the
status and progress of such submissions.
(b) Opportunity to Comment on
Regulatory Submissions. AstraZeneca shall provide Nektar with
an opportunity to review and comment upon any applications for Health
Registration Approval for the [***] and for the [***], in each case, for the
[***], prior to the anticipated date of such submissions. AstraZeneca
shall reasonably consider Nektar’s comments with respect to such submissions in
good faith.
(c) Written Communications with
FDA. AstraZeneca shall promptly provide Nektar with copies of
all material written or electronic communications received by it or its
Affiliates from, or forwarded or submitted by it or its Affiliates to, the
Health Authorities within the United States with respect to any Licensed Product
(provided that
AstraZeneca may redact any portions relating to aspects of any Combination
Product that are proprietary to AstraZeneca, its Affiliates or any Third Party
including any proprietary compounds or any other proprietary technology of
AstraZeneca, its Affiliates or any Third Party). Such material
communications shall be provided by AstraZeneca to Nektar [***] of such receipt
or forwarding.
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(d) Meetings with
FDA. To the extent practicable, AstraZeneca shall [***] with
prior written or email notice of all meetings,
conferences and discussions that are scheduled with the FDA regarding any
Licensed Product [***] after AstraZeneca or its Affiliate first receives notice
of the scheduling of such meeting, conference or discussion (or within such
shorter period as may be practicable and necessary in order to give Nektar a
[***] to attend such meetings, conferences and discussions). For
clarity, AstraZeneca shall not have any obligation to give Nektar the
opportunity to attend meetings, conferences and discussions with the FDA that
are [***], but shall use reasonable efforts to give Nektar notice as soon as
practicable (whether prior to or after such meetings, conferences or
discussions) of such meetings, conferences and discussions, if
material. Subject to the confidentiality provisions set forth under
Article 11, and to the extent permitted by the FDA, Nektar shall be entitled to
have [***]. The number of representatives and the identities of such
representatives to be present at any such meeting, conference or discussion
shall be determined by AstraZeneca in its good faith judgment, based solely upon
considerations relating to conducting an effective interaction with the
FDA. AstraZeneca shall not be required to account for the schedules
of the Nektar representatives in scheduling such meetings, conferences or
discussions except to the extent that AstraZeneca is requiring the attendance of
certain Nektar representatives, in which case AstraZeneca shall conduct such
scheduling reasonably and in good faith. AstraZeneca shall promptly
forward to Nektar copies of all meeting minutes and summaries of all such
meetings, conferences and discussions with the FDA.
(e) End of Phase II
Meeting. AstraZeneca shall involve Nektar in the development
of the agenda and the preparation of materials to be submitted to FDA for the
end of Phase II meeting with FDA relating to the Existing Product (the “End of Phase II Meeting”), and
shall provide Nektar with an opportunity to review and comment upon the agenda
and materials prior to their submission to
FDA. [***]. AstraZeneca shall reasonably consider Nektar’s
comments with respect to such submission in good faith. Subject to
Nektar’s right to have [***], the number of Nektar representatives and the
identities of such representatives to be present at such meeting shall be
determined by AstraZeneca in its good faith judgment, based solely upon
considerations relating to conducting an effective interaction with the FDA, but
provided
that [***]. AstraZeneca
shall provide Nektar with an opportunity to reasonably review any materials to
be submitted to FDA in response to the End of Phase II Meeting, and shall
reasonably consider Nektar’s comments with respect to any such submission in
good faith.
6.8. Reporting.
(a) FDA and EMEA
Activities. At each JPT meeting (but not more than once per
[***]), AstraZeneca’s members on the JPT will provide a report to the JPT of the
development activities conducted on Compounds and Licensed Products relating to
generating data intended to be used in filing for Health Registration Approvals
by the FDA or the European Commission since the last meeting (including the
filing of INDs with the FDA, the EMEA or Health Registration Authorities in any
Major European Market), a reasonable summary of the results of such activities
and progress of such development, which report is not required to be in
writing. In addition, AstraZeneca shall provide Nektar with [***]
written report on such development activities, which report shall contain (i) a
summary of the development activities planned to be conducted in the next [***]
and (ii) sufficient detail to enable the JPT to assess AstraZeneca’s progress
with respect to development activities that have been conducted [***] and
compliance with its diligence obligations in Sections 6.3 and 6.4,
including: (A) AstraZeneca’s, or its Sublicensees’ or its Affiliates’
activities with respect to seeking and achieving Health Registration Approvals,
and (B) clinical study results and other results of such development
activities. In addition, AstraZeneca shall notify Nektar of the
filing or approval of any application for Health Registration Approval for a
Licensed Product or major supplements or amendments thereto with or by the FDA,
the EMEA or the European Commission, no later than [***] after the filing or
approval thereof in the [***], and no later than [***]after the filing or
approval thereof [***] or the [***]. AstraZeneca shall have no
obligation to provide a translation of any such application for Health
Registration Approval (if there are any applications for Health Registration
Approval in languages other than English) unless AstraZeneca has made such a
translation for its own internal review.
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(b) Other Development
Activities. At least once every [***], AstraZeneca shall also
provide to the JPT a high-level report (which shall not be required to be in
writing) of any development and regulatory efforts by AstraZeneca, its
Affiliates and Sublicensees relating to Licensed Products in the Territory,
other than those efforts already reported to the JPT under Section
6.8(a). In addition, AstraZeneca shall notify Nektar of the filing
and approval of any application for Health Registration Approval for a Licensed
Product or major supplements or amendments thereto with or by any Health
Authority other than the FDA or the EMEA no later than [***] after such filing
or approval. AstraZeneca shall have no obligation to provide a
translation of any such application for Health Registration Approval (if there
are any applications for Health Registration Approval in languages other than
English) unless AstraZeneca has made such a translation for its own internal
review.
(c) Commercialization. Commencing
as of the first Health Registration Approval for a Licensed Product in the
Territory, at each JPT meeting (but not more than once per [***]), AstraZeneca’s
members on the JPT shall provide an update to the JPT regarding AstraZeneca’s
general commercialization efforts relating to Licensed Products in the United
States and the Major Commercial Markets since the last meeting (but in the case
of the Major Commercial Markets, only to the extent such information is
reasonably available to AstraZeneca’s JPT members from such Major Commercial
Markets at the time of such JPT meeting). The update shall generally
describe, for each such country and Licensed Product, AstraZeneca’s level of
commercial efforts (such as prescription, sales, and promotion data), marketing
strategy and plans for future commercialization efforts, but such update shall
not require AstraZeneca to include information deemed to constitute highly
proprietary or competitively sensitive marketing strategy or related information
and is not required to be in writing. Commencing as of the first
Health Registration Approval for a Licensed Product in the Territory,
AstraZeneca shall provide Nektar with [***] written report on such
commercialization activities, which report shall contain (i) a general summary
of the commercialization activities planned to be conducted in the [***], and
(ii) a high-level report of its commercialization efforts relating to Licensed
Products in the Territory outside of the United States and the Major Commercial
Markets, if there are any such efforts to report.
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6.9. Publications and
Presentations. Nektar acknowledges that scientific publications relating
to Compounds, Licensed Products and Reserved Products must be properly monitored
to prevent any material adverse effect from premature publication of results of
the research and development activities with respect to any of the
foregoing. Accordingly, Nektar shall and shall cause its Affiliates
to comply with Section 6.9(a) with respect to any publication or other public
presentation or disclosure to a Third Party of any Product Publication or Other
Publication (each, a “Publication”).
(a) Review
Process. Prior to disclosing any Publication, Nektar shall
provide AstraZeneca with a written copy of the proposed Publication at least
[***] prior to the scheduled date of publication, presentation, submission, or
disclosure (unless the material is an abstract, scientific poster or
presentation, in which case Nektar shall provide AstraZeneca with a written copy
of the proposed Publication at least [***] prior to the scheduled date of
publication, presentation, submission, or disclosure). Nektar shall
not publish or otherwise publicly disclose the proposed Product Publication
prior to consideration thereof by AstraZeneca, which consideration must be
conducted by AstraZeneca [***] receipt by AstraZeneca, and Nektar shall consider
in good faith any comments offered with respect thereto by AstraZeneca,
including with respect to any proposed deletions of Confidential Information of
AstraZeneca, Restricted Information, or patentable Information. With
respect to any such Product Publication, the Parties shall endeavor to come to
agreement on the content of such Product Publications and if the Parties are
unable to come to agreement on such content, then AstraZeneca shall have the
right to (i) require that Nektar remove from such Publication Confidential
Information of AstraZeneca or Restricted Information and (ii) approve the
content of such Publication, provided that such
approval shall not be unreasonably withheld and that in making such decision
AstraZeneca shall reasonably consider Nektar’s comments and AstraZeneca’s
Publication policies, as such policies are modified from time to time by
AstraZeneca. With respect to Other Publications, Nektar shall [***]
any comments offered with respect thereto provided by AstraZeneca [***] of its
receipt of the proposed Other Publication, including with respect to any
proposed deletions of Confidential Information of AstraZeneca, Restricted
Information, or patentable Information. Following such [***] of
AstraZeneca’s comments, Nektar may publish any Other
Publications. The Parties acknowledge that as of the Execution Date,
Nektar is planning to disclose or otherwise publish the Publications identified
on Exhibit G (the “Existing
Publications”). Notwithstanding the general procedures set
forth in this Section 6.9(a), but subject to the right of AstraZeneca to require
that Nektar remove from the applicable Publication Confidential Information of
AstraZeneca or Restricted Information, AstraZeneca agrees that, following
advance disclosure to AstraZeneca of such Publications as set forth in this
Section 6.9(a) and good faith consideration of AstraZeneca’s comments thereto,
Nektar may publish the [***]. Nothing in the foregoing shall prevent,
or be interpreted to prevent, Nektar from making such public disclosures as are
required by Applicable Law or the requirements of any stock exchange on which
Nektar’s securities are listed.
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(b) AZ Publication
Policy. Notwithstanding anything to the contrary in this
Agreement, nothing in this Agreement shall preclude AstraZeneca or any of its
Affiliates from complying with AstraZeneca’s publication policies with respect
to the development and other activities contemplated by this Agreement, as such
policies are modified from time to time by AstraZeneca in any respect or manner,
provided
that the foregoing
shall not permit AstraZeneca to disclose any confidential [***] without Nektar’s
written consent.
6.10. Information Disclosure;
Assistance.
(a) Nektar
shall, and shall cause its Affiliates to, without additional compensation,
disclose and make available to AstraZeneca, in whatever form AstraZeneca may
reasonably request (provided that [***]
any Information from its current form to any such requested form), Regulatory
Documentation and all Licensed Know-How and Joint Know-How relating directly to
or reasonably needed for AstraZeneca to develop or otherwise Exploit the
Licensed Products that AstraZeneca is, at the applicable time, intending to
Exploit (which, as of the Effective Date, include the Existing Product and an
Opioid Combination Product), immediately after the Effective Date to the extent
covering existing Information and not disclosed to AstraZeneca already (but
excluding manufacturing-related Information covered by Section 8.2), and
thereafter promptly upon the earlier of the development, making, conception or
reduction to practice of each such Regulatory Documentation, Licensed Know-How
or Joint Know-How; provided, however, that the
foregoing shall not be construed to relieve AstraZeneca from any payment
obligation under this Agreement or the Manufacturing and Technology Transfer
Agreement, which the Parties agree will provide that AstraZeneca shall bear
certain technology transfer costs incurred by Nektar thereunder.
(b) Except
as set forth in Section 8.2 with respect to all activities under the Manufacture
and Technology Transfer Agreement, Nektar, without additional compensation,
shall provide AstraZeneca with reasonable assistance to the extent required in
order to transfer the Licensed Know-How to AstraZeneca in a timely manner as
needed for AstraZeneca to Exploit the Existing Product and at least one Opioid
Combination Product. Without prejudice to the generality of the
foregoing, if [***] are reasonably required by AstraZeneca for purposes of
transferring such Licensed Know-How to AstraZeneca or for purposes of
AstraZeneca acquiring expertise on the practical application of the Licensed
Know-How or assisting on issues arising during such Exploitation (and other than
the transfer contemplated under the MTTA), Nektar shall [***] appropriate
representatives to AstraZeneca’s facilities, [***]. The Parties
contemplate that the Manufacturing and Technology Transfer Agreement shall
include more detailed provisions regarding technology transfer related to the
Manufacture of the Existing Product, which provisions shall be without
limitation of the general obligation set forth in this Section
6.10(b).
(c) Nektar
shall maintain, or cause to be maintained, accurate records of its development
and other activities directly related to Compounds, Licensed Products and
Reversion Products under this Agreement and any Ancillary Agreement in
sufficient detail and in good scientific manner appropriate for patent and
regulatory purposes, which shall be complete and accurate and shall fully and
properly reflect all work done and results achieved in the performance of its
activities hereunder, which shall record only such activities and shall not
include or be commingled with records of activities outside the scope of this
Agreement, and which shall be retained by Nektar for [***] after the termination
of this Agreement, or for such longer period as may be required by Applicable
Law. AstraZeneca shall have the right, during normal business hours
and upon reasonable notice, to inspect and copy any such
records.
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(d) AstraZeneca
shall maintain, and shall cause its Affiliates and Sublicensees to maintain,
accurate records of all development activities under this Agreement and any
Ancillary Agreement directly related to development of Licensed Products in such
detail as typically recorded by AstraZeneca for its own similar products, and
which shall be retained by AstraZeneca for at least [***] the termination of
this Agreement, or for such longer period as may be required by Applicable
Law.
7.
Consideration
7.1. Milestone
Payments. In partial consideration of the licenses and other
rights granted by Nektar to AstraZeneca under this Agreement, AstraZeneca shall
pay Nektar in readily available funds the following payments following
achievement of the applicable milestone events by AstraZeneca or its Affiliate
or Included Sublicensee (which payments are non-creditable and
non-refundable):
(a) a
payment of One Hundred Twenty-Five Million U.S. Dollars ($125,000,000) within
[***] following the Effective Date, [***] of which the Parties acknowledge and
agree is reimbursement of Nektar’s past research and development expenses with
respect to the Licensed Products (but, for clarity, which expenses are not
reimbursable unless and until such payment becomes due under this Agreement
following the Effective Date);
(b) with
respect to the Stand-Alone Products containing NKTR-118 (which, for clarity,
include the Packaged 118 Opioid Product, but not Opioid Combination Products,
which are addressed in Section 7.1(c)):
(i) a
payment of [***] (subject to Section 7.10(a)) within [***];
(ii) a
payment of [***] (subject to Section 7.10(a)) within [***];
(iii) a
payment of [***];
(iv) a
payment of [***];
(v) a
payment of [***];
(vi) a
payment of [***];
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(vii) a
payment of [***];
(viii) a
payment of [***];
(ix) a
payment of [***];
No
payment in this Section 7.1(b) shall be made more than once irrespective of the
number of Stand-Alone Products that have achieved the milestone events set forth
in this Section 7.1(b), or the number of countries in which such milestone
events have been achieved.
(c) with
respect to [***] to achieve the following events:
(i) a
payment of [***];
(ii) a
payment of [***];
(iii) a payment of [***];
(iv)
a payment of [***];
(v) a payment of [***];
(vi) a payment of [***];
and
(vii) a
payment of [***].
It is
expressly understood that the milestone payments set forth in this subsection
(c) above shall be made with respect to [***] to meet any of the trigger events
in this subsection, but no payment in this Section 7.1(c) will be made more than
[***] irrespective of the number of [***] that have achieved the milestone
events set forth in this Section 7.1 after such [***] of any particular
milestone event, or the number of countries in which such milestone events have
been achieved.
(d) Adjustment of Sales
Milestone Payments. With respect to any milestone event in
Sections 7.1(b)(v)-(ix) achieved by [***] containing [***] (which for clarity
include [***]), or a milestone event in Sections 7.1(c)(iii)-(vii) achieved by
an [***], if during the Calendar Year in which such milestone event was achieved
there were [***] selling the applicable Licensed Product(s) that achieved such
milestone event, then the milestone payment payable for such milestone event
shall be reduced by an amount equal to [***].
7.2. Royalties. In
addition to the foregoing payments, AstraZeneca shall pay Nektar the royalties
set forth below.
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(a) [***]. Subject
to Section 7.7, AstraZeneca shall pay Nektar the following royalties with
respect to all [***] containing [***] (which for clarity include the [***] (but
subject to applicable adjustments as provided in Section 7.3)):
(i) on
the Net Sales of [***] containing [***] in the [***] (but excluding the Net
Sales of such product by an [***]) as follows:
(A) [***]
of Net Sales for that portion of aggregate Net Sales of such [***] in the [***]
during a Calendar Year that are [***];
(B) [***]
of Net Sales for that portion of aggregate Net Sales of such [***] in the [***]
during a Calendar Year that equal or exceed [***];
(C) [***]
of Net Sales for that portion of aggregate Net Sales of such [***] in the [***]
during a Calendar Year that equal or exceed [***];
(D) [***]
of Net Sales for that portion of aggregate Net Sales of such [***] in the [***]
during a Calendar Year that equal or exceed [***]; and
(E) [***]
of Net Sales for that portion of aggregate Net Sales of such [***] in the [***]
during a Calendar Year that equal or exceed [***];
(ii) on
the Net Sales of all [***] containing [***] in the [***] (but excluding the Net
Sales of such product by an [***]) as follows:
(A) [***]
of Net Sales for that portion of aggregate Net Sales of such [***] in the [***]
during a Calendar Year that are less than [***];
(B) [***]
of Net Sales for that portion of aggregate Net Sales of such [***] in the [***]
during a Calendar Year that [***] are less than [***];
(C) [***]
of Net Sales for that portion of aggregate Net Sales of such [***] in the [***]
during a Calendar Year that [***] but are less than [***];
(D) [***]
of Net Sales for that portion of aggregate Net Sales of such [***] in the [***]
during a Calendar Year that [***] but are less than [***]; and
(E) [***]
of Net Sales for that portion of aggregate Net Sales of such [***] in the [***]
during a Calendar Year that equal or exceed [***].
(b) [***]
Products. Subject to Sections 7.3 and 7.7, AstraZeneca shall
pay Nektar the following royalties with respect to each [***]
Product:
(i) on
the Net Sales of each [***] Product in the United States (but excluding the Net
Sales of such product by an [***]) as follows:
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(A) [***]
of Net Sales for that portion of aggregate Net Sales of such [***] Product in
the United States during a Calendar Year that are less than [***];
(B) [***]
of Net Sales for that portion of aggregate Net Sales of such [***] Product in
the United States during a Calendar Year that [***] but are less than
[***];
(C) [***]
of Net Sales for that portion of aggregate Net Sales of such [***] Product in
the United States during a Calendar Year that equal or exceed [***] but are less
than [***];
(D) [***]
of Net Sales for that portion of aggregate Net Sales of such [***] Product in
the United States during a Calendar Year that equal or exceed [***] but are less
than [***];
(E) [***]
of Net Sales for that portion of aggregate Net Sales of such [***] Product in
the United States during a Calendar Year that equal or exceed
[***];
(ii) on
the Net Sales of each [***] Product in the [***] (but excluding the Net Sales of
such product by an Excluded Sublicensee) as follows:
(A) [***]
of Net Sales for that portion of aggregate Net Sales of such [***] Product in
the [***] during a Calendar Year that are less than [***];
(B) [***]of
Net Sales for that portion of aggregate Net Sales of such [***] Product in the
[***] during a Calendar Year that equal or exceed [***] but are less than
[***];
(C) [***]
of Net Sales for that portion of aggregate Net Sales of such [***] Product in
the [***] during a Calendar Year that equal or exceed [***] but are less than
[***];
(D) [***]
of Net Sales for that portion of aggregate Net Sales of such [***] Product in
the [***] during a Calendar Year that equal or exceed [***] but are less than
[***]; and
(E) [***]
of Net Sales for that portion of aggregate Net Sales of such [***] Product in
the [***] during a Calendar Year that [***].
The
calculation of royalties under this Section 7.2 shall be [***].
7.3. [***]. With
respect to [***] Products and [***] Products (in each case, an “[***]”), the Net
Sales based on sales of any such [***] Product in a given country or territory
to be used for purposes of determining whether the sales milestones in Section
7.1(c) (in the case of [***] Products) or 7.1(b) (in the case of [***] Products)
are achieved, and for purposes of calculation of the royalties owed on such
sales under Section 7.2(b) (in the case of [***]) or 7.2(a) (in the case of
[***] Products) (including determining the applicable thresholds and ceilings
and any applicable step-down or adjustment), shall be determined as follows
[***].
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The [***]
for the [***] containing [***] and for each other active ingredient (i.e., the
[***] or [***] other than [***]) shall be for a quantity comparable to that used
in such [***]and of the [***], during the same time period and in the applicable
country. If, in a specific country for a particular [***] Product,
the specific information required to perform the foregoing calculation
applicable to such [***] Product is not available, then the Parties shall
negotiate in good faith and agree on a method of determining the [***] of the
[***] Product in a manner that replicates as nearly as possible to the [***] as
described above. As used herein, and “[***]” means a [***] (and not,
for example, an [***], ingredient to increase [***]).
7.4. Consideration for [***]
Products. If AstraZeneca (or its Affiliate or Sublicensees)
elects to clinically develop and (if successful) commercialize a [***] Product
that is not an [***] Product (an “[***]”), [***].
7.5. [***]. The
milestones and royalties in Sections 7.1, 7.2 and 7.3 shall not apply to
development and commercialization of Licensed Products [***]. In the
event that AstraZeneca (or its Affiliate or Sublicensee) develops a Licensed
Product intended for commercial [***], the Parties shall negotiate reasonably
and in good faith and agree in writing on commercially reasonable milestones and
royalties applicable to the development and sale of such Licensed Product, which
shall reflect the [***] of such Licensed Product for the intended use based on
[***] in the [***] for similar [***], as applicable, and taking into account the
[***] and [***] payments due by AstraZeneca hereunder. AstraZeneca
covenants that it and its Affiliates and Sublicensees shall not conduct [***] on
or [***] any Licensed Product for any [***] unless and until the Parties have
agreed in writing on the [***], including [***] and [***], if mutually agreed,
to be paid by AstraZeneca for such [***] and [***]. If the Parties
are unable to agree on the [***] that AstraZeneca will make with respect to a
Licensed Product for any [***], then such dispute shall be resolved pursuant to
Section 19.4.
7.6. Sublicensees.
(a) Election. In
the event AstraZeneca or any of its Affiliates grants a sublicense to a
Sublicensee, AstraZeneca shall elect, by written notice to Nektar prior to the
date that any payment would first be due to Nektar by AstraZeneca under any term
of this Agreement based upon such grant of sublicense or the actions of the
Sublicensee, whether AstraZeneca shall compensate Nektar with respect to such
Sublicensee’s activities either as described in Section 7.6(b), or in Section
7.6(c). If AstraZeneca elects the compensation model described in
Section 7.6(b) with respect to a Sublicensee, such Sublicensee shall constitute
an “[***]”. If AstraZeneca elects the compensation model described in
Section 7.6(c) with respect to a Sublicensee, such Sublicensee shall constitute
an “[***]”. For clarity, once AstraZeneca has elected a method of
compensating Nektar with respect to a Sublicensee’s activities, AstraZeneca may
not thereafter alter such election.
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(b) [***]. For
all [***] elected by AstraZeneca pursuant to Section 7.6(a), the applicable
milestone payments shall be made under Sections 7.1(b) and (c) for milestone
events therein achieved by such [***], and all the Net Sales of such [***] shall
be included for purposes of calculating the sales milestones set forth in
Section 7.1 and of royalties under Section 7.2 (including in determining
thresholds and ceilings in the royalty tiers). AstraZeneca shall not
owe Nektar any [***] or [***] made by the [***] to AstraZeneca (or its
Affiliate).
(c) Sharing of Sublicense
Income. For all [***] elected by AstraZeneca pursuant to
Section 7.6(a), no milestone payments shall be made under Sections 7.1(b) and
(c) based on the activities of any such [***] (but provided that for clarity each such
milestone event shall be deemed “achieved” upon completion or achievement of the
applicable event by AstraZeneca or its Affiliate or [***] even if an [***] had
previously achieved such event), and all the Net Sales of such [***] shall be
excluded from the calculation of royalties owed under Section 7.2; provided, however, the Net
Sales of all [***] shall be included for purposes of calculating the total
Annual Net Sales for determining if sales milestones set forth in Section 7.1
have been achieved and for determining thresholds and ceilings in the royalty
tiers used in calculating the royalties under Section
7.2. AstraZeneca shall pay to Nektar [***] of any [***] received by
AstraZeneca or any Affiliate from an [***], such payments to be made
[***]. “[***]” means, with respect to the applicable
[***].
7.7. Reduction of
Royalty.
(a) Generic
Competition. If, with respect to a Licensed Product being sold
in a country in a particular Calendar Quarter, any Generic Product of such
Licensed Product is sold by any Third Party in such country in such Calendar
Quarter, then for the purposes of determining the royalties due based on the
sale of such Licensed Product under Sections 7.2, 7.4, 7.5 and 7.10(b) (as
adjusted by the other provisions of this Section 7.7) in such country during
such Calendar Quarter, the royalty owed by AstraZeneca on sales of such Licensed
Products in such country in such Calendar Quarter shall be [***].
(b) Compulsory
Licenses. In the event that a court or a governmental agency
of competent jurisdiction requires AstraZeneca or an AstraZeneca Affiliate or
Sublicensee to grant a compulsory license to a Third Party permitting such Third
Party to make or sell a Licensed Product in a country in the Territory, then for
the purposes of calculating the royalties due under Sections 7.2, 7.4, 7.5 and
7.10(b), with respect to such Licensed Product in such country (but solely for
so long as such compulsory license is in effect and products are being sold
under the license in such country), the royalty rate on Net Sales shall be
[***].
(c) No Valid
Claim. In the event that, at the time a Licensed Product is
sold in a country, there is no Valid Claim in such country with respect to such
Licensed Product, then for the purposes of calculating the royalties owed based
on the sale of such Licensed Product under Sections 7.2, 7.4, 7.5 and 7.10(b) at
that time, the royalties that would otherwise be owed and payable under such
Sections based on such sale shall be [***]. The calculation of the
royalty reduction under this Section 7.7(c) shall be conducted separately for
each Licensed Product.
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(d) [***]
Reduction. Any reductions set forth in this Section 7.7 and in
Section 7.8 shall be applied to the royalty rate payable to Nektar under Section
7.2 and the milestones in Section 7.1 that are based on Annual Net Sales in the
[***].
7.8. Royalty
Stacking. If, during the Term, AstraZeneca enters into an
agreement with a Third Party under which it obtains a license under a patent
right of a Third Party in a particular country in the Territory that [***],
then, upon entry into any such agreement and thereafter during the remainder of
the period during which AstraZeneca owes royalties to such Third Party under
such agreement and to Nektar under this Agreement based upon sales of any [***]
Product containing [***] or any [***] Product containing [***] in such country,
the royalty amounts payable under Section 7.2 hereof based on sales of any [***]
Product containing [***] or [***] Product in the country shall be
[***].
7.9. Royalty
Term. AstraZeneca’s obligation to pay royalties shall
commence, on a country-by-country basis, with respect to each separate Licensed
Product, on the date of First Commercial Sale of such Licensed Product in such
country. The obligation shall expire, on a country-by-country basis,
with respect to each separate Licensed Product:
(a) in
the case of any country in the [***], on the [***] (i) [***] of the First
Commercial Sale of such Licensed Product in the European Union and (ii) the
expiration date in such country of the last to expire of any issued Licensed
Patent that includes at least [***] covering the sale or use of such separate
Licensed Product in such country; or
(b) in
the case of any country not in the [***], the [***] (i) [***] of the First
Commercial Sale of such Licensed Product in such country and (ii) the expiration
date in such country of the last to expire of any issued Licensed Patent that
includes at least [***] covering the sale or use of such separate Licensed
Product in such country.
7.10. Certain Additional
[***].
(a) [***].
(b) Consideration for Compounds
Other than [***]. If AstraZeneca (or its Affiliate or
Sublicensees) elects to develop and (if successful) commercialize a Stand-Alone
Product containing a Compound other than [***] (and such compound is viewed as a
new chemical entity by the FDA) (a “[***] Compound”), then AstraZeneca
shall give Nektar written notice of such election, describing the [***] Compound
covered by such election. After any such notice, the Parties then
shall [***]. AstraZeneca covenants that it and its Affiliates and
Sublicensees shall not [***], subject to the terms of this Agreement and such
commercial payments.
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7.11. Sales Subject to
Royalties. Sales of Licensed Products between [***] shall not
be subject to royalties hereunder (except as otherwise provided in Section
7.6(c)), provided that royalties shall be
calculated on AstraZeneca’s [***] sale of the Licensed Products to a Third Party
(including [***]). Royalties shall be payable only once for any given
quantity of Licensed Products. For purposes of determining Net Sales,
the Licensed Product shall be deemed to be sold when invoiced and a “sale” shall
not include, and no royalties shall be payable on, transfers by AstraZeneca, its
Affiliates or Sublicensees of free samples of Licensed Products or of clinical
trial materials containing Compound that are transferred without charge or at a
price that does not result in a profit to the transferring party, or transfers
of Licensed Products to patients under AstraZeneca’s Patient Assistance Program
or compassionate use program in the US or any similar programs in other
countries, or other transfers or dispositions without charge or at a price that
does not result in a profit to the transferring party for charitable,
promotional, pre-clinical, clinical, manufacturing, testing or qualification,
regulatory or governmental purposes.
7.12. Royalty
Payments. The royalties shall be [***] respectively, for the
[***]. AstraZeneca shall pay the royalties in conjunction with the
delivery of a written report to Nektar within [***] after the end of [***] that
shows, with respect to each country and each Licensed Product,
[***].
7.13. [***]. If
AstraZeneca’s (or its Affiliates’ or Sublicensees’) [***] for the sale or
distribution of the Licensed Products [***], the Parties agree to negotiate in
good faith and agree on [***] obligations for those obligations hereunder which
are based on the [***], which [***] obligations shall be designed to provide
Nektar [***] to the [***] that would have been paid to Nektar hereunder if the
calculation of Net Sales were [***].
7.14. Records Retention;
Audit.
(a) Until
[***], AstraZeneca and its Affiliates shall keep or cause to be kept accurate
records or books of account in accordance with applicable generally accepted
accounting principles showing all information and data that is necessary for the
accurate determination of the royalties and other payments due hereunder with
respect to the sale or other Exploitation of Licensed Product.
(b) Upon
the written request of Nektar, AstraZeneca shall permit a qualified accountant
or a person possessing similar professional status and associated with an
independent accounting firm of nationally recognized standing selected by Nektar
and reasonably acceptable to AstraZeneca to inspect during regular business
hours and [***], all or any part of AstraZeneca’s and its Affiliates’ records
and books necessary to check the accuracy of the royalties and other amounts
paid under this Agreement. The accounting firm shall enter into an
appropriate agreement with AstraZeneca to treat all information it receives
during its inspection in confidence. The accounting firm shall
disclose to Nektar and AstraZeneca only whether the royalty reports and other
payment amounts made are correct and details concerning any discrepancies, but
no other information shall be disclosed to Nektar. The charges of the
accounting firm shall be paid by Nektar, except that if the royalties or other
payments have been [***], the charges shall be paid by
AstraZeneca. If Nektar does not exercise its right under this Section
7.14(b) with respect to [***] within the time period allotted therefor, it shall
constitute a waiver by Nektar of its right to later object to any payments made
by AstraZeneca under this Agreement [***].
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7.15. Mode of
Payment. [***].
7.16. Currency. All
payments required under this Article 7 shall be made in U.S.
Dollars. For the purpose of computing the Net Sales of Licensed
Products sold in a currency other than U.S. Dollars, such currency shall be
converted from local currency to U.S. Dollars by AstraZeneca in accordance with
the rates of exchange for the relevant month for converting such other currency
into U.S. Dollars used by AstraZeneca’s actual internal accounting systems that
are independently audited on an annual basis and are consistently applied to its
products.
7.17. Taxes.
(a) General. The
royalties, milestones and other amounts payable by AstraZeneca to Nektar
pursuant to this Agreement (“Payments”) shall not be
reduced on account of any taxes unless required by Applicable
Law. Nektar alone shall be responsible for paying any and all taxes
(other than withholding taxes required by Applicable Law to be paid by
AstraZeneca) levied on account of, or measured in whole or in part by reference
to, any Payments it receives. AstraZeneca shall deduct or withhold
from the Payments any taxes that it is required by Applicable Law to deduct or
withhold. Notwithstanding the foregoing, if Nektar is entitled under
any applicable tax treaty to a reduction of rate of, or the elimination of,
applicable withholding tax, it may deliver to AstraZeneca or the appropriate
governmental authority (with the assistance of AstraZeneca to the extent that
this is reasonably required and is expressly requested in writing) the
prescribed forms necessary to reduce the applicable rate of withholding or to
relieve AstraZeneca of its obligation to withhold tax, and AstraZeneca shall
apply the reduced rate of withholding, or dispense with withholding, as the case
may be, provided that
AstraZeneca has received evidence, in a form reasonably satisfactory to
AstraZeneca, of Nektar’s delivery of all required forms (and, if necessary, its
receipt of appropriate governmental authorization) at least [***] prior to the
time that the Payments are due. Further, if Nektar is entitled under
any applicable tax treaty to a reduction of rate of, or the elimination of,
applicable withholding tax, but Nektar has not been (or believes it will not be)
able to deliver to AstraZeneca (or the appropriate governmental authority) the
prescribed forms as provided above, with respect to a particular Payment owed
under this Agreement, by the above-required time prior to the date the Payment
is due, then Nektar may by written notice to AstraZeneca delay such due date
until a specified later time (so as to enable Nektar to submit on a timely basis
such prescribed forms and thus be able to benefit from the protections from
withholding afforded by such tax treaty), and in such case AstraZeneca shall not
make such Payment until the later date as specified by Nektar in writing and
shall cooperate reasonably with Nektar’s efforts to submit the prescribed forms
and benefit from the tax treaty (with the understanding that AstraZeneca shall
pay such Payment amount on such specified later date). If, in
accordance with the foregoing, AstraZeneca withholds any amount, it shall pay to
Nektar the balance when due, make timely payment to the proper taxing authority
of the withheld amount, and send to Nektar proof of such payment [***] following
that payment, and shall cooperate reasonably with Nektar’s efforts to obtain the
benefit of any tax credits with respect to such withholding. For
purposes of this Agreement, the stated amount of the Payments payable by
AstraZeneca shall include any sales tax that Nektar may be required to
collect.
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(b) Indirect
Taxes. Nothing in Section 7.17(a) shall apply with respect to
Indirect Taxes. If any Indirect Taxes are chargeable in respect of
any Payments, AstraZeneca shall pay such Indirect Taxes at the applicable rate
in respect of any such Payments following the receipt, where applicable, of an
Indirect Taxes invoice in the appropriate form issued by Nektar in respect of
those Payments, such Indirect Taxes to be payable on the due date of the payment
of the Payments to which such Indirect Taxes relate.
7.18. Imports. For
the avoidance of doubt, the Parties acknowledge and agree that none of the
milestones or royalties payable under this Agreement are related to the license
(or right) to import or any import of Licensed Products. The
receiving Party shall be responsible for any import clearance, including payment
of any import duties and similar charges, in connection with any Licensed
Products transferred to such Party under this Agreement.
7.19. Interest. If
a Party does not receive payment of any sum due to it hereunder on or before the
due date therefor, [***] shall thereafter accrue on the sum due to such Party
until the date of payment at a [***] of [***], or the [***]. This
Section 7.19 shall not apply to any payment by AstraZeneca that is made after
the due date therefor based on a request from Nektar to defer such payment
pursuant to Section 7.17(a).
8.
Manufacturing and Supply
8.1. Clinical
Supplies.
(a) Ordering. Subject
to the terms and conditions of this Agreement, until the Manufacture and
Technology Transfer Agreement is entered into by the Parties, promptly upon
request of AstraZeneca, Nektar shall use commercially reasonable efforts to
supply to AstraZeneca, in accordance with Applicable Law in the United States or
any other jurisdictions in which the applicable supplies are Manufactured by or
on behalf of Nektar (“Manufacturing Law”), clinical
supplies of the Existing Products and placebos (if applicable), in such form and
in such quantities as may be required for any clinical studies to be conducted
by AstraZeneca hereunder. Such supply shall be pursuant to [***],
consistent with industry standards. If AstraZeneca orders any
clinical supplies hereunder, the price for such supplies shall be equal to
[***]. Upon the execution of the MTTA, the Parties agree that the
price charged to AstraZeneca under this Agreement shall be [***] had such
clinical supplies been purchased under the MTTA at the price set forth
therein. Within [***] of the execution of the MTTA, Nektar shall
issue AstraZeneca an invoice for the amount of underpayment or refund for the
amount of overpayment, as applicable.
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(b) Product
Warranty. At the time of delivery to AstraZeneca by or on
behalf of Nektar of all Existing Product ordered by AstraZeneca under subsection
(a), (i) the Existing Product shall be in conformity with the applicable
specifications therefor; (ii) the Existing Product shall have been Manufactured
in compliance with cGMP, all Manufacturing Law, and the applicable terms of this
Agreement; (iii) the Existing Product shall have been Manufactured in facilities
that are in compliance with all Manufacturing Law at the time of such
Manufacture (including applicable inspection requirements of the FDA and other
Health Authorities); (iv) the Existing Product shall not be adulterated or
misbranded under the FFDCA; and (v) Nektar shall have sufficient stability data
to support the planned Phase III Clinical Trial as set forth in the IND for the
Existing Product. AstraZeneca’s [***] (except as provided in Section
14.2) shall be [***]. For clarity, the foregoing warranty does not
cover or apply to any damage or harm to, or other non-conformity of, the
Existing Product caused by improper handling, storage, transportation or use of
the Existing Product after delivery to AstraZeneca by Nektar.
(c) Quality
Agreement. Within [***] following the Execution Date, Nektar
shall execute a reasonable quality agreement based substantially on
AstraZeneca’s then-current form, which shall govern the Parties’ respective
responsibilities with respect to quality-related matters applicable to clinical
supplies of the Existing Product and placebos (if applicable).
8.2. Manufacture and Technology
Transfer.
(a) Manufacturing Technology
Transfer. Nektar shall, and shall cause its Affiliates to,
disclose and make available to AstraZeneca, in accordance with the terms of a
Manufacture and Technology Transfer Agreement to be agreed to by the Parties as
provided in subsection (b) below, all Licensed Know-How and Joint Know-How
relating directly to manufacture of NKTR-118, the Existing Product or an Opioid
Combination Product that is necessary or reasonably useful to enable AstraZeneca
or its designee to manufacture the Existing Product.
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(b) Negotiation. Within
[***] following the Effective Date, AstraZeneca and Nektar shall negotiate the
terms of a manufacturing agreement, pursuant to which (i) Nektar shall make
available to AstraZeneca and its designee the Information described in Section
8.2(a), and (ii) without limitation of Section 8.1, Nektar shall be responsible
for using [***] to Manufacture such non-commercial supplies of the Existing
Product as AstraZeneca may reasonably require to conduct clinical trials of the
Existing Product until the technology transfer described in subsection (a) is
complete and AstraZeneca or its designee is able to commence Manufacture of the
Existing Product (such agreement, the “Manufacture and Technology Transfer
Agreement”). The Parties shall negotiate the Manufacture and
Technology Transfer Agreement reasonably and in good faith and with such
diligence, including by making available such personnel as are necessary to
negotiate, as is required to execute and deliver such an agreement within [***]
of the Effective Date, or such other period as the Parties may agree in
writing. The Parties agree that the MTTA shall require the Parties to
work together cooperatively to effect the contemplated manufacturing technology
transfer as soon as practicable, with the understanding that such transfer
should be able to be completed within [***]. If such Manufacture and
Technology Transfer Agreement is not executed by the Parties within such period,
either Party shall have the right to refer the resolution of any dispute with
respect to such Manufacture and Technology Transfer Agreement to the Executives
pursuant to Section 19.1. Any final decision mutually agreed to by
the Executives shall be reflected in the final, agreed Manufacture and
Technology Transfer Agreement. If the Executives are not able to
agree on the resolution of any such issue within [***] after such issues was
first referred to them or if, following an agreement in principle by the
Executives, the Parties are not able to expeditiously, and in no event later
than [***] after a decision is reached by the Executives, reflect such agreement
in the final agreed Manufacture and Technology Transfer Agreement, either Party
may, by written notice to the other, elect to initiate arbitration pursuant to
Section 19.4 for purposes of having the matter settled.
(c) Certain
Terms. The Manufacture and Technology Transfer Agreement shall
provide that (i) AstraZeneca shall [***] in connection with the transfer of the
manufacturing technology to AstraZeneca, (ii) the price at which AstraZeneca
shall [***] under the Manufacture and Technology Transfer Agreement shall be
equal to [***], and (iii) Nektar shall provide as part of such technology
transfer or any supply of clinical supplies hereunder, all necessary product and
batch related documentation to AstraZeneca to support clinical use of the
Existing Product. The Parties anticipate and agree that the transfer
of Manufacturing responsibility to AstraZeneca under the Manufacture and
Technology Transfer Agreement shall take place as promptly as reasonably
practicable and that the Parties shall cooperate and take all reasonable actions
to facilitate such transfer, and that Nektar’s obligation to Manufacture the
Existing Product pursuant to Section 8.1 and Section 8.2 shall remain in place
only until the completion of the technology transfer.
8.3. Right to Audit. Upon
AstraZeneca’s reasonable request, Nektar shall allow AstraZeneca or its
authorized representatives to audit Nektar’s premises and records (including
those related to Nektar’s subcontractors and suppliers, but solely to the extent
Nektar has the right to compel such audit) that relate directly to the
Manufacture of Existing Product supplied by Nektar under this Article 8, solely
for purposes of verifying Nektar’s performance of Health Authority requirements
in the United States and the requirements in this Agreement with respect to such
Manufacture. This audit may be made as a quality and compliance
audit, an integrated supplier evaluation protocol (ISEP) audit, or an audit for
cause. Any such audit shall be conducted pursuant to the
confidentiality provisions of Article 11 and any other appropriate
confidentiality agreement, during normal business hours and after reasonable
prior written notice, and in compliance with reasonable restrictions and rules
as required by Nektar for safety and confidentiality purposes and to avoid undue
interference with Nektar’s (and its applicable subcontractors’ and suppliers’)
businesses.
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8.4. CMC
Services. Upon AstraZeneca’s reasonable request, Nektar shall
use commercially reasonable efforts to provide any CMC services requested by
AstraZeneca at Nektar’s [***], to the extent Nektar has the required expertise
and experience, and provided that the
Parties shall reasonably cooperate to minimize interference with Nektar’s other
business commitments.
9.
Ownership of Intellectual
Property
9.1. Ownership of
Technology.
(a) Ownership. Subject
to Section 9.2 and the license grants to AstraZeneca under Article 4 and the
license grant to Nektar under Section 9.1(b), as between the Parties, [***] all
right, title and interest in and to any and all: (i) Information, Improvements
and other inventions that are conceived, discovered, developed or otherwise
made, as necessary to establish authorship, inventorship or ownership under
applicable United States law, by or on behalf of [***] (or its Affiliates or its
licensees (other than, in the case of Nektar, AstraZeneca or its Sublicensees)
or Sublicensees) under or in connection with this Agreement, whether or not
patented or patentable, and any and all Patent and Intellectual Property Rights
with respect thereto, except to the extent that any such Information,
Improvements or other inventions, or any Patent or Intellectual Property Rights
with respect thereto, are Joint Know-How or Joint Patents, and (ii) other
Information, Improvements or other inventions, and Patent and Intellectual
Property Rights that are owned or otherwise Controlled (other than pursuant to
the license grants set forth in Article 4) by [***], its Affiliates or its
licensees (other than, in the case of Nektar, AstraZeneca or its Sublicensees)
or Sublicensees.
(b) License Grant to
Nektar. Subject to the terms and conditions of this Agreement,
AstraZeneca hereby grants to Nektar [***] license throughout the world, [***]
pursuant to Section 9.1(c), under AstraZeneca’s and its Affiliates’ right,
title, and interest in and to Information made, created, discovered, developed,
conceived or reduced to practice pursuant to work under this Agreement that
comprise, claim or cover [***] disclosed or made known to AstraZeneca (or its
Affiliate) in connection with this Agreement, and any Patents filed based on any
such Information (collectively, the “[***]”), to use and practice such [***] for
any purpose other than, until the expiration of the exclusivity of AstraZeneca’s
licenses granted under Section 4.1, the Exploitation of the Compounds, the
Licensed Products and the Competing Products (but provided that the foregoing license
excludes, for clarity, the right to use any Information generated by AstraZeneca
(or its Affiliate) specifically relating to the Compounds, Licensed Products and
Reserved Products, including any clinical data).
(c) [***]. Nektar
shall have the right to [***], under the license granted in Section 9.1(b), to
its [***] upon prior written notice to AstraZeneca. Nektar shall
ensure that all [***] to which it [***] are bound by commercially reasonable
confidentiality obligations consistent with the intent of clause (b) covering
any confidential Information of AstraZeneca covered by such
[***].
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9.2. Ownership of Licensed
Patents and Licensed Know-How. Subject to the license grants
to AstraZeneca under Article 4, as between the Parties, Nektar shall own and
retain all right, title and interest in and to all Licensed Patents and Licensed
Know-How.
9.3. Improvements, Excluded
Patents and Excluded Know-How.
(a) Nektar
shall without delay disclose to AstraZeneca any Improvements that become
Controlled by Nektar or its Affiliates, during any period in which AstraZeneca
owes royalties to Nektar pursuant to Section 7.9, and are necessary or
reasonably useful for AstraZeneca to develop or otherwise Exploit the Compounds
and Licensed Products that AstraZeneca is, at the applicable time, intending to
Exploit (but excluding manufacturing-related Information covered by Section 8.2)
and provide AstraZeneca with all relevant Information comprising such
Improvements. AstraZeneca shall have the right, at any time, to
reject any such Improvement on written notice to Nektar, in which event, this
Agreement shall not apply to such Improvement.
(b) All
Improvements disclosed by Nektar pursuant to Section 9.3(a) shall, for clarity,
automatically be included within the licenses granted to AstraZeneca hereunder,
subject to AstraZeneca’s right to reject any such Improvement pursuant to
Section 9.3(a), and any Information Controlled by Nektar or its Affiliates
comprising such Improvements that is not covered or claimed by a Patent and
which is not generally known shall be considered Licensed
Know-How. For clarity, any Patents that are Controlled by Nektar or
its Affiliates that cover such Improvements shall be considered Licensed
Patents.
(c) If,
after the Effective Date and subject to Section 17.1, Nektar (or its Affiliate)
desires to [***] from a Third Party specific Patents or proprietary Information
[***] to the extent relating to rights that could be [***] to AstraZeneca
hereunder. If Nektar (or its Affiliate) [***] from such Third Party
any [***] (absent a rejection as provided below), then Nektar shall
[***].
9.4. Ownership of Joint
Inventions, Joint Patents and Joint Know-How. Subject to the
license grants to AstraZeneca under Article 4, the Parties shall each own an
equal, undivided interest in any and all (a) Information that is conceived,
discovered, developed or otherwise made, as necessary to establish authorship,
inventorship or ownership under applicable United States law, jointly by or on
behalf of Nektar (or its Affiliates), on the one hand, and AstraZeneca (or its
Affiliates, its Distributors or its Sublicensees), on the other hand, in
connection with the work conducted under or in connection with this Agreement,
whether or not patented or patentable (the “[***]”), and (b) Patents (the
“[***]”) and Intellectual Property Rights with respect
thereto. [***]. Notwithstanding the foregoing, subject to
the [***] restrictions set forth in [***] and the [***], with respect to any
[***] or [***] that comprise, claim or cover [***], Nektar shall have the right
to [***] in such [***] and [***] without AstraZeneca’s consent and without
accounting to AstraZeneca.
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9.5. Assignments. Each
Party shall obtain from each of its Affiliates, sublicensees, employees and
agents, and from the employees and agents of its Affiliates, sublicensees and
agents, who are or will be involved in the Manufacture of Licensed Products or
are otherwise participating in the Exploitation of the Compounds or Licensed
Products or who otherwise have access to any Restricted Information or other
Confidential Information of the other Party, rights to any and all Information
that relate to a Compound or Licensed Product, such that each Party shall, by
virtue of this Agreement, receive from the other Party, without payments beyond
those required by Article 7, the licenses and other rights granted to such Party
by the other Party under the terms of this Agreement.
10. Adverse
Event Reporting; Recall
10.1. Safety
Agreement. On or within [***]
following the Execution Date, the Parties shall enter into a safety
agreement with respect to the Licensed Products based on AstraZeneca’s
then-current standard safety agreement governing the Parties’ respective
responsibilities with respect to Adverse Events, complaints and other
safety-related matters (the “Safety
Agreement”).
10.2. Adverse Event
Reporting. The rights and obligations of the Parties (and
their Affiliates) with respect to safety and related reporting activities with
respect to each Licensed Product shall be set forth in the Safety
Agreement. AstraZeneca shall be responsible for Adverse Event
reporting to applicable Health Authorities in the Territory. Nektar
shall report and provide to AstraZeneca all Adverse Event information relating
to the Licensed Products of which it becomes aware (a) [***] for any reports of
Adverse Events that [***] or are [***] and (b) [***] for any reports of
[***]. Nektar and AstraZeneca shall reasonably cooperate to ensure
that Nektar’s Adverse Event reporting processes will efficiently communicate
such Adverse Event information in such manner, time, and format.
10.3. Complaints. Without
limitation of Section 10.2, Nektar shall maintain a record of any and all
complaints it receives with respect to the Licensed Products and shall notify
AstraZeneca in reasonable detail of any complaint received by it [***] after
receipt of such complaint by Nektar. For so long as Licensed Product
is being manufactured by or on behalf of Nektar hereunder, AstraZeneca shall
maintain a record of any and all complaints it or its Affiliates receives with
respect to Licensed Products, and shall notify Nektar in reasonable detail or
any complaint received by it or its Affiliates [***] or, following execution of
the MTTA, within the [***] set forth therein or in a quality agreement entered
into between the Parties pursuant to the MTTA.
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10.4. Product
Recall.
(a) Notification and
Recall. In the event that any government agency or authority
issues or requests a recall or takes similar action in connection with the
Compounds or the Licensed Products, or in the event AstraZeneca determines that
an event, incident or circumstance has occurred that may result in the need for
a recall or market withdrawal with respect to the Compounds or the Licensed
Products, AstraZeneca shall promptly advise Nektar thereof by telephone or
facsimile. Following notification of any such issuance or request or
similar action to AstraZeneca or such a determination by AstraZeneca,
AstraZeneca shall decide and have control of whether to conduct such a recall or
market withdrawal (except in the case of a government-mandated recall) in the
Territory and the manner in which any such recall or market withdrawal shall be
conducted.
(b) Recall
Expenses. AstraZeneca shall [***] of any recall of a Licensed
Product. Such expenses of recall shall include [***] of the recalled
Licensed Product and any [***] for the recalled Licensed
Product. However, to the extent that any such recall covers Licensed
Products supplied by Nektar to AstraZeneca under this Agreement or the MTTA,
then Nektar will be responsible for paying such costs of such recall to the
extent that such recall is attributable to [***] or the [***] set forth in the
[***] with respect to such Licensed Products.
11.
Confidentiality and
Non-Disclosure
11.1. Restricted Nektar
Information. Nektar recognizes that by reason of, inter alia, AstraZeneca’s
status as an exclusive licensee pursuant to the grants under Section 4.1,
AstraZeneca has an interest in Nektar’s retention in confidence of Licensed
Know-How and Joint Know-How that relates to the Compounds, the Licensed Products
or the Reserved Products. Accordingly, until the expiration of the
exclusivity of AstraZeneca’s license rights with respect to a Licensed Product
under Section 4.7, Nektar shall, and shall cause its Affiliates and their
respective officers, directors, employees and agents to, keep completely
confidential, and not publish or otherwise disclose, and not use for any purpose
(except as expressly permitted under this Agreement) any such Licensed Know-How
and Joint Know-How that comprises or relates to any Licensed Product, including
the Compound included therein, and any Regulatory Documentation, including the
Health Registration Approvals, with respect thereto (the “Restricted Information”);
provided
that the “Restricted Information” shall
not include any Information to the extent (a) such Information is in the
public domain through no fault of Nektar, its Affiliates or any of their
respective officers, directors, employees or agents, (b) disclosure or use of
the Information by Nektar would be expressly permitted under Section 11.3, or
(c) disclosure or use of the Information by Nektar is otherwise expressly
permitted by the terms of this Agreement, or (d) such Information is generally
related to and useful in [***] business, including the discovery, research
and/or development of compounds that are not [***]. For
clarification, the disclosure by Nektar to AstraZeneca of Restricted Information
shall not cause such information to cease to be subject to the provisions of
this Section 11.1. In the event this Agreement is [***] by
AstraZeneca pursuant to [***], or by Nektar pursuant to [***] (other than this
final sentence) shall terminate and have no continuing force or effect and the
[***] (other than the [***] included therein) shall thereafter be deemed solely
to be Confidential Information of Nektar, for purposes of the surviving
provisions of this Agreement. Nektar shall ensure that each of its
and its Affiliates’ employees is bound by a written confidentiality agreement
that is at least as protective of the Restricted Information and the
Confidential Information of AstraZeneca as the provisions set forth in this
Article 11. AstraZeneca shall ensure that each of its and its
Affiliates’ employees who is involved in the performance of AstraZeneca’s
obligations or exercise of AstraZeneca’s rights under this Agreement or any
Ancillary Agreement is bound by a written confidentiality agreement that is at
least as protective of the Restricted Information and the Confidential
Information of Nektar as the provisions set forth in this Article
11.
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11.2. Confidentiality
Generally. Subject to Section 11.1, at all times during the
term of this Agreement and for a period of [***] following termination or
expiration hereof, each Party (the “Receiving Party”) shall, and
shall cause its officers, directors, employees, agents, Affiliates and
Sublicensees to, keep confidential and not publish or otherwise disclose and not
use, directly or indirectly, for any purpose, any Confidential Information
provided to it by the other Party (the “Disclosing Party”), except to
the extent such disclosure or use is otherwise expressly permitted by the terms
of this Agreement or is reasonably necessary for the performance of this
Agreement. For the avoidance of doubt, the treatment of Confidential
Information that is also Restricted Information is governed by the terms of
Section 11.1 while the treatment of Confidential Information that is not also
Restricted Information is governed by this Section 11.2.
11.3. Permitted
Disclosures. Nektar may disclose Restricted Information and
each Party may disclose Confidential Information of the other Party (other than
Restricted Information) to the extent that such disclosure is:
(a) made
in response to a valid order of a court of competent jurisdiction or other
competent authority; provided, however, that the
Receiving Party shall first have given notice to the Disclosing Party and given
the Disclosing Party a reasonable opportunity to quash any such order or obtain
a protective order requiring that the Confidential Information and documents
that are the subject of such order be held in confidence by such court or
authority or, if disclosed, be used only for the purpose for which the order was
issued; and provided further that if such
order is not quashed or a protective order is not obtained, the Confidential
Information disclosed in response to such court or governmental order shall be
limited to that information that is legally required to be disclosed in response
to such court or governmental order;
(b) made
by AstraZeneca or its Affiliates, Distributors or Sublicensees to a Health
Authority as may be necessary or useful in connection with any filing,
application or request for a Health Registration Approval; provided, however, that
reasonable measures shall be taken to assure confidential treatment of such
information, to the extent such protection is available;
(c) made
by a Party to a patent authority as may be necessary or useful for purposes of
obtaining or enforcing a Patent (consistent with the terms and conditions of
Article 15); provided, however, that
reasonable measures shall be taken to assure confidential treatment of such
information, to the extent such protection is available;
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(d) otherwise
required by law; provided, however, that if
Nektar is required to disclose Restricted Information, or either Party is
required to disclose Confidential Information of the other Party, the Party
required to make the disclosure shall (i) provide to the other Party reasonable
advance notice of and an opportunity to comment on any such required disclosure,
(ii) if requested by the other Party, seek confidential treatment with respect
to any such disclosure to the extent available, and (iii) use good faith efforts
to incorporate the comments of the other Party in any such disclosure or request
for confidential treatment; or
(e) made
by AstraZeneca or its Affiliates, Distributors or Sublicensees to Third Parties
as may be reasonably necessary in connection with the Exploitation of the
Compounds or Licensed Products as contemplated by this Agreement, including
subcontracting or sublicensing transactions in connection
therewith.
11.4. Exclusions. Notwithstanding
the foregoing, Confidential Information (but not Restricted Information) shall
not include any information that:
(a) is
or hereafter becomes part of the public domain by public use, publication,
general knowledge or the like through no wrongful act, fault or negligence on
the part of the Receiving Party;
(b) can
be demonstrated by documentation or other competent proof to have been in the
Receiving Party’s or its Affiliates’ possession prior to disclosure by the
Disclosing Party;
(c) is
subsequently received by the Receiving Party or its Affiliates from a Third
Party or a Sublicensee who is not bound by any obligation of confidentiality
with respect to said information;
(d) is
generally made available to Third Parties by the Disclosing Party without
restriction on disclosure; or
(e) is
independently developed by or for the Receiving Party or its Affiliates without
reference to the Disclosing Party’s Confidential Information.
Specific
aspects or details of Confidential Information or Restricted Information shall
not be deemed to be within the public domain or in the possession of the
Receiving Party merely because the Confidential Information or Restricted
Information is embraced by more general information in the public domain or in
the possession of the Receiving Party. Further, any combination of
Confidential Information or Restricted Information shall not be considered in
the public domain or in the possession of the Receiving Party merely because
individual elements of such Confidential Information or Restricted Information
are in the public domain or in the possession of the Receiving Party unless the
combination and its principles are in the public domain or in the possession of
the Receiving Party.
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11.5. Confidentiality of Terms of
Agreement. The Parties both agree that the terms of the
Agreement are the confidential information of each Party, and they each shall
keep such terms confidential and not disclose the Agreement, except as otherwise
provided herein. Notwithstanding the foregoing, the Parties
acknowledge and agree that either Party may be required by Applicable Law or the
requirements of a national securities exchange or another similar regulatory
body to disclose this Agreement, or the terms hereof, in whole or in part, and
in such case, such Party shall notify the other Party in writing and shall
provide the other Party with at least [***] thereof prior to making such filing
or disclosure. The disclosing Party shall use reasonable efforts to
seek confidential treatment of any such proposed redactions timely made, to the
extent consistent with law, and use reasonable efforts to procure confidential
treatment of such proposed redactions pursuant to the Securities Act of 1933 or
the Securities Exchange Act of 1934, in each case as amended, and the rules,
regulations and guidelines promulgated thereunder, or any other applicable law
or the rules, regulations or guidelines promulgated thereunder, but provided that the foregoing shall not
prevent the Party from making such public disclosures as it, on advice of
counsel, must make to comply with Applicable Law. Either Party may
disclose the terms of this Agreement in confidence to (a) its directors,
Affiliates and professional service providers and (b) [***] and their respective
[***] who, in each case ((a) and (b)) are subject to [***] (or if applicable
[***]), which restrictions shall, inter alia, in the case of
the Persons described in clause (b), limit the permitted use of the terms of
this Agreement solely to [***] and [***] of the [***] and for no other
purpose.
11.6. Use of
Name.
(a) Neither
Party shall disclose or otherwise commercially use the name, insignia, symbol,
trademark, trade name or logotype of the other Party or its Affiliates in any
publication, press release, promotional material or other form of publicity
without the prior written consent of the other Party (which shall not be
unreasonably withheld or delayed), except for those disclosures for which
consent has previously been obtained. The restrictions imposed by
this Section 11.6(a) shall not prohibit either Party from making any
disclosure identifying the other Party that is required by Applicable Law or the
requirements of a national securities exchange or another similar regulatory
body, provided
that any such disclosure shall be governed by this Article
11. Further, the restrictions imposed on each Party under this
Section 11.6 are not intended, and shall not be construed, to prohibit a Party
from identifying the other Party in its internal business communications, provided that any
Confidential Information in such communications remains subject to this Article
11.
(b) Notwithstanding
the foregoing, AstraZeneca and its Affiliates and Sublicensees shall have the
right to use in a reasonable manner the name of Nektar and its Affiliates to the
extent that (i) AstraZeneca is required by Applicable Law to identify
Nektar or its applicable Affiliate as having developed or Manufactured Licensed
Products sold in the Territory or (ii) as reasonably requested by AstraZeneca in
connection with its Exploitation of the Licensed Products, subject, in the case
of clause (ii) to the consent of Nektar, not to be unreasonably
withheld.
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11.7. Press
Release. The Parties have agreed upon the content of a joint
press release which shall be issued substantially in the form attached hereto as
Exhibit D, the release of which the Parties will coordinate in order to
accomplish the same promptly upon execution and delivery of this
Agreement. Except to the extent already disclosed in a press release
or other public communication, no public announcement concerning this Agreement,
its subject matter or the transactions described herein shall be made, either
directly or indirectly, by Nektar or AstraZeneca or their respective Affiliates,
except as may be legally required by Applicable Laws, judicial order, or
required by stock exchange or quotation system rule without first obtaining the
approval of the other Party and agreement upon the nature, text and timing of
such announcement, which approval and agreement shall not be unreasonably
withheld or delayed. The Party desiring to make any such voluntary
public announcement shall provide the other Party with a written copy of the
proposed announcement in reasonably sufficient time prior to public release to
allow such other Party to comment upon such announcement, prior to public
release. In the case of press releases or other public communications
legally required, or required by stock exchange or quotation system rule, to be
made, the Party making such press release or public announcement shall provide
to the other Party a copy of the proposed press release or public announcement
in written or electronic form upon such advance notice as is practicable under
the circumstances for the purpose of allowing the notified Party to review and
comment upon such press release or public announcement. Under such
circumstances, the releasing Party shall not be obligated to delay making any
such press release or public communication beyond the time when the same is
required to be made in order to facilitate review and comment by the receiving
Party.
12.
Trademarks
AstraZeneca
shall have the sole right to select the Trademarks for the marketing and sale of
the Licensed Products in the Territory, provided that no such Trademarks
shall be [***] to, [***] or [***] with respect to or that [***] the [***] that
are set forth in Exhibit H (as such Exhibit may be updated [***] from time to
time). AstraZeneca shall own such Trademarks and all Intellectual
Property Rights and other rights and goodwill with respect
thereto. Nektar shall not, and shall not permit its Affiliates to,
use any trademark that is the same as or confusingly similar to, misleading or
deceptive with respect to or that dilutes the Trademarks. If
requested by Nektar, AstraZeneca shall consult reasonably with Nektar if Nektar
wishes AstraZeneca to include Nektar’s corporate name or corporate trademark in
connection with the marketing and sale of Licensed Products (which inclusion
shall be in AstraZeneca’s sole discretion) and, if applicable, the location and
size of such corporate name or corporate trademark, which location and size to
be agreed between the Parties. Nektar acknowledges that the inclusion
of Nektar’s corporate name or corporate trademark within marketing materials
associated with Licensed Products may be limited or restricted by regulatory
authorities, and AstraZeneca agrees that any such inclusion shall comply with
all reasonable use guidelines and requirements of Nektar, as provided by Nektar
to AstraZeneca from time to time.
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13.
Representations, Warranties and Covenants
13.1. Representations, Warranties,
and Covenants of Nektar. Nektar represents, warrants, and
covenants to AstraZeneca as of the Execution Date as follows:
(a) Nektar
or its Affiliate is the sole and exclusive owner of the entire right, title and
interest in the Licensed Know-How that is specific to NKTR-118 and the Existing
Product and the Licensed Product Patents, and is entitled to grant the licenses
specified in Section 4.1. Such rights are not subject to any
encumbrance, lien or claim of ownership by any Third Party that conflict with
the exclusive licenses granted in Section 4.1(a). During the Term,
Nektar and its Affiliates shall not encumber or diminish the rights granted to
AstraZeneca under Section 4.1(a) or Section 4.1(c) with respect to the Licensed
Patents (except as expressly permitted in Article 18).
(b) [***],
the Licensed Product Patents are being [***] before the respective Patent
Offices in accordance with Applicable Law. The Licensed Product
Patents have been [***] properly and correctly and all [***] have been [***] the
due date for [***].
(c) [***],
there is no [***] or [***] of the Licensed Product Patents, or [***] of the
Licensed Know-How that is specific to NKTR-118 or the Existing Product or of the
Regulatory Documentation, ongoing by any Third Party.
(d) [***],
AstraZeneca’s Exploitation of the [***], or [***] in combination with a [***]
(whether [***] or [***]), using the Regulatory Documentation, the Licensed
Patents and Licensed Know-How as contemplated under this Agreement will not
infringe any Patent or misappropriate any proprietary right of any Third Party
(other than any such infringement that would arise from (i) the Exploitation of
the applicable [***] or [***] in an [***] in the absence of [***], (ii) the
[***] whereby such [***] or [***] is included in the [***] or (iii) the [***] of
the [***]).
(e) [***],
the Licensed Know-How that is specific to NKTR-118 or the Existing Product, and
the Licensed Product Patents, in each case as of the Execution Date, are [***]
and, [***], there are no Patents or other prior art that render such Patents
[***], in whole or in part. [***], the creation of the Regulatory
Documentation, and the conception, development and reduction to practice of
Licensed Know-How that is specific to NKTR-118 or the Existing Product, and the
Licensed Product Patents, in each case as of the Execution Date, have not
constituted or involved the misappropriation of trade secrets of any Third
Party.
(f) [***],
there are no claims, judgments or settlements against Nektar or any of its
Affiliates, or amounts owed by Nektar or any of its Affiliates with respect
thereto, relating to the Regulatory Documentation, the Licensed Product Patents,
or the Licensed Know-How. There is no pending claim or litigation
brought by any Person alleging that (i) the Licensed Product Patents are invalid
or unenforceable or (ii) the creation of the Regulatory Documentation, or the
Exploitation of the Existing Product based upon the Regulatory Documentation,
violates or infringes any Patent or other intellectual property right of any
Third Party. [***] all past claims or litigation brought by any
Person (and the [***]) alleging that (A) the [***] or the [***] are invalid or
unenforceable or (B) the creation of the [***], or the [***] of the [***] based
upon the [***], violates or infringes any Patent or other intellectual property
right of any Third Party.
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(g) Nektar
has not previously entered into any agreement under which it has encumbered its
right, title or interest in or to, the Licensed Know-How that is specific to
NKTR-118 or the Existing Product, Licensed Product Patents, or Regulatory
Documentation, (including by granting any covenant not to xxx with respect
thereto) in a manner that [***] granted under Section 4.1 (as compared to the
[***] under the terms of this Agreement in the absence of such agreement), and
it will not enter into any such agreements or grant any such right, title or
interest to any Person that will have the effect of limiting the scope or
exclusivity of such license rights granted to AstraZeneca under Section 4.1 of
this Agreement.
(h) In
respect of the [***] included in the Licensed Product Patents, Nektar and its
Affiliates have [***] of which it and the inventors [***]. In respect
of any [***] (as of the Execution Date) [***] included in the Licensed Product
Patents, Nektar and its Affiliates presented all [***] of which it and the
inventors were [***] at the United States Patent and Trademark
Office.
(i) [***],
the Licensed Product Patents listed on Exhibit E represent all Patents within
Nektar’s or its Affiliates’ ownership or Control that [***] to the Compounds and
Licensed Products as of the Execution Date (with the understanding that certain
claims in the Nektar Technology Patents cover certain Compounds or Licensed
Products or aspects thereof [***]). [***], (x) there are no Patents
owned or licensed by Nektar as of the Execution Date that claim or cover
NKTR-118, the Existing Product or other Licensed Products (as contemplated as of
the Execution Date) and are not within the Licensed Patents, and (y) there is no
Information owned or licensed by Nektar as of the Execution Date that directly
relates to NKTR-118, the Existing Product or other Licensed Products (as
contemplated as of the Execution Date) and is not within the Licensed
Know-How.
(j) [***],
each of the Licensed Product Patents [***] thereof as determined in accordance
with the laws of the jurisdiction in which such Licensed Patent is issued or
such application is pending.
(k) [***],
each Person who has or has had any rights in or to any Licensed Know-How owned
by Nektar that is specific to NKTR-118, the Existing Product, or any Opioid
Combination Product or to any Licensed Product Patents, [***] entire right,
title and interest in and to such Licensed Product Patent and Licensed Know-How
to Nektar or its Affiliates. With regard to any inventor of any
Licensed Product Patent from whom Nektar does not have a [***] of his or her
right, title and interest in and to such Licensed Product Patent as of the
Execution Date in a form reasonably acceptable to AstraZeneca, Nektar shall
secure such [***] in a form reasonable acceptable to AstraZeneca as promptly as
practicable and shall make available to AstraZeneca any and all such
[***].
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(l) [***],
the Licensed Know-How that is specific to NKTR-118 or the Existing Product has
been kept confidential or has been disclosed to Third Parties only under terms
of confidentiality (except that certain general aspects of such Information may
have been publicly disclosed by Nektar (for example, in securities filings or
investor disclosures) in a manner that does not [***] of the Licensed Know-How
or the [***] of the Licensed Products). [***], no breach of such
confidentiality has been committed by any Third Party. For the
avoidance of doubt, the [***] existing as of the Execution Date have not, other
than to the extent they have been part of a patent application that is in the
public domain or in a regulatory filing, been publicly disclosed to any Third
Party.
(m) Nektar
or its Affiliates have made available to AstraZeneca, [***], for review in due
diligence (i) all clinical and pre-clinical data relating to the Licensed
Products existing as of the [***] that is intended for use in applications for
Health Registration Approval and any final reports with respect to such clinical
and pre-clinical data in Nektar’s or its Affiliates’ possession, (ii) all
Regulatory Documentation requested by AstraZeneca or, [***], that is material to
the development of NKTR-118, the Existing Product or any Opioid Combination
Products in the forms existing as of the [***], and (iii) other material
Licensed Know-How relating directly to NKTR-118, the Existing Product or any
Opioid Combination Products in the forms existing as of the
[***]. [***], since the date on which Nektar [***], Nektar has not
come into the possession of any of the foregoing categories of information that
would be material to the development of NKTR-118, the Existing Product or any
Opioid Combination Products in the forms existing as of the
[***]. [***], all Regulatory Documentation and Licensed Know-How
regarding or related to any existing Compound or the Existing Product disclosed
by Nektar or its Affiliates to AstraZeneca under this Agreement is true and
correct in all [***]. [***], Nektar and its Affiliates have prepared,
maintained and retained all Regulatory Documentation that is required to be
maintained or reported pursuant to and in accordance with good laboratory and
clinical practice and Applicable Law and, [***], all Information therein is true
and correct.
(n) [***],
all adverse information with respect to the safety and efficacy of the Licensed
Products known to Nektar or its Affiliates [***] has been disclosed by Nektar or
its Affiliates to AstraZeneca through due diligence review.
(o) [***],
Nektar and its Affiliates have conducted, and have caused their respective
contractors and consultants to conduct, any and all preclinical and clinical
studies related to the Compounds and Licensed Products in material accordance
with good laboratory and clinical practice (but excluding from the foregoing any
preclinical studies that need not comply (for regulatory purposes) with the
foregoing requirements) and Applicable Law. [***], Nektar and its
Affiliates have employed Persons with appropriate education, knowledge and
experience to conduct and to oversee the conduct of any and all preclinical and
clinical studies related to the Compounds and Licensed
Products. Nektar is not aware of any Information that [***] could
adversely affect the acceptance, or the subsequent approval, by any Heath
Authority of any filing, application or request for Health Registration Approval
for the Existing Product, other than Information disclosed to AstraZeneca in the
due diligence review.
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(p) During
the period from the Execution Date through the end of the Term of this
Agreement, Nektar shall obtain from each of its Affiliates, sublicensees (other
than Sublicensees), employees and agents, and from the employees and agents of
its Affiliates, sublicensees (other than Sublicensees) and agents, who are or
will be involved in the Manufacture of the Licensed Product or are otherwise
participating in the Exploitation of the Compounds or Licensed Products or who
otherwise have access to any Restricted Information or other Confidential
Information of AstraZeneca, rights to any and all Information that relate to the
Compound or Licensed Products and are generated pursuant to and during the time
of such Person’s relationship with Nektar or its Affiliate, such that
AstraZeneca shall, by virtue of this Agreement, receive from Nektar, without
payments beyond those required by this Agreement, the licenses and other rights
granted to AstraZeneca hereunder (and such that the scope of such licenses and
other rights are not limited in scope or exclusivity by a failure to so obtain
such rights from such Persons).
(q) During
the period from the [***] until the [***], Nektar and its Affiliates shall
conduct its research and development with respect to the Licensed Products in
the [***], including [***] with the FDA or [***] for the Existing Product prior
to the Effective Date.
(r) In
the event that any Patents or Information Controlled by Nektar or its Affiliates
as of the [***] would be Licensed Patents or Licensed Know-How, as applicable,
if such Patent or Know-How were Controlled by Nektar or its Affiliates as of the
Effective Date, then Nektar agrees that during the period from the Execution
Date until the Effective Date, it shall not and shall cause its Affiliates not
to (i) incur, create, assume or permit the incurrence, creation or assumption of
any encumbrance, lien or claim of ownership by any Third Party with respect to
such Patents or Information, (ii) dispose of any of such Patents or Information,
or (iii) waive, release, grant, license or transfer any right, title or interest
in or to any such Patents or Information in any manner that would limit the
scope of the Intellectual Property Rights included in, or the exclusivity of the
license rights granted in Section 4.1.
(s) Promptly
following the [***], and no later than [***] thereafter, Nektar shall inform
AstraZeneca in writing if Nektar or any of its Affiliates becomes aware that the
representations and warranties made by Nektar pursuant to Sections 13.1 and 13.2
as of the [***] are not true and correct in any material respects on and as of
the [***] as though made on and as of the [***].
(t) [***],
Exhibit B lists all Patents that, [***], meet the definition of “Nektar Technology Patents” as
of the [***]; Nektar shall use reasonable efforts to update such Exhibit from
time to time to reflect any additional Patents that are Controlled by Nektar (or
its Affiliate) and that it becomes aware meet such definition.
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13.2. Mutual Representations,
Warranties, and Covenants. Each Party represents and warrants to the
other Party as of the Execution Date and as of the Effective Date
that:
(a) it
has full corporate power and authority to enter into this Agreement and to carry
out the provisions hereof;
(b) it
has full legal power to extend the rights and licenses granted to the other
under this Agreement;
(c) it
has taken all necessary action on its part required to authorize the execution
and delivery of this Agreement; and
(d) neither
it nor its Affiliates has been debarred or is subject to
debarment. Neither it nor its Affiliates will use in any capacity, in
connection with the services to be performed under this Agreement, any Person
who has been debarred pursuant to Section 306 of the FFDCA, or who is the
subject of a conviction described in such section. If such Party is
Nektar, neither Nektar nor its Affiliates has used in any capacity, in
connection with the Exploitation of the Compounds or Licensed Products prior to
the Effective Date, any Person who has been debarred pursuant to Section 306 of
the FFDCA, or who was the subject of a conviction described in such
section. Such Party agrees to inform the other Party in writing
immediately if it or any Person who is performing services hereunder is debarred
or is the subject of a conviction described in Section 306, or if any action,
suit, claim, investigation or legal or administrative proceeding is pending or,
to the best of such Party’s or its Affiliates’ knowledge, is threatened,
relating to the debarment or conviction of such Party or any Person performing
services hereunder.
13.3. DISCLAIMER OF
WARRANTY. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN
SECTIONS 8.1(b), 13.1(a) THROUGH 13.1(t) and 13.2, NEITHER ASTRAZENECA NOR
NEKTAR MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED,
EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND EACH PARTY
SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS
OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A
PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR
THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD
PARTIES. NOTHING IN THIS SECTION 13.3 SHALL OPERATE TO LIMIT OR
INVALIDATE ANY EXPRESS WARRANTY OR REPRESENTATION CONTAINED IN ANY ANCILLARY
AGREEMENT.
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14.
Indemnity
14.1. Indemnification of
Nektar. In addition to any other remedy available to Nektar,
AstraZeneca shall indemnify, defend and hold harmless Nektar, its Affiliates and
its and their respective directors, officers and employees (each a “Nektar Party”) in full and on
demand, from and against any and all Losses incurred by them to the extent
resulting from or arising out of or in connection with any claims or allegations
made or suits, actions or proceedings brought by a Sublicensee or Third Party
(collectively, “Third Party
Claims”) against any Nektar Party that arise or result: (a) from any
[***] on the part of AstraZeneca or any of its Affiliates, Sublicensees or
Distributors in performing any activity contemplated by this Agreement or any
Ancillary Agreement, or the [***] of any provision of this Agreement or any
Ancillary Agreement by AstraZeneca; or (b) from the Exploitation of a Compound,
Licensed Product or Reserved Product by or on behalf of AstraZeneca or any of
its Affiliates, Sublicensees or Distributors, including any violation of
Applicable Law in connection with such Exploitation and any Third Party Claims
alleging that the claimant has [***] as a result of the use of the Licensed
Products sold or distributed by or on behalf of AstraZeneca or any of its
Affiliates, Sublicensees or Distributors, except, in each case ((a) or (b)), (i)
for any Losses for which Nektar has an obligation to indemnify any AstraZeneca
Party pursuant to Section 14.2, as to which Loss each Party shall indemnify the
other to the extent of their respective liability for such Loss, (ii) to the
extent such Losses arise or result from the [***] of a Nektar Party, or the
[***] of any provision of this Agreement or any Ancillary Agreement by Nektar;
and (iii) to the extent Nektar has an obligation to indemnify an AstraZeneca
Party for any such Losses pursuant to an Ancillary Agreement (which agreement
shall set forth the relationship between an indemnification obligation arising
under this Agreement and any indemnification obligation under such
agreement).
14.2. Indemnification of
AstraZeneca. In addition to any other remedy available to
AstraZeneca, Nektar shall indemnify, defend and hold harmless AstraZeneca, its
Affiliates, Distributors, Sublicensees and its and their respective directors,
officers and employees (each an “AstraZeneca Party”) in full
and on demand, from and against any and all Losses incurred by them to the
extent resulting from or arising out of or in connection with any Third Party
Claims against any AstraZeneca Party that arise or result from:
(a) (i)
any [***] on the part of Nektar or its Affiliates in performing any activity
contemplated by this Agreement or any Ancillary Agreement, or the [***] of any
provision of this Agreement or any Ancillary Agreement by Nektar; or (ii) the
Exploitation of a Compound, Licensed Product or Reserved Product by or on behalf
of Nektar or any of its Affiliates, which claim(s) is based on [***], in whole
or in part, prior to the Effective Date, including any violation of Applicable
Law in connection with such Exploitation and any Third Party Claims that allege
that the claimant has suffered [***] as a result of the use of the Licensed
Products distributed by or on behalf of Nektar or any of its Affiliates [***];
except, in each case ((i)) and (ii)), (A) for any Losses for which AstraZeneca
has an obligation to indemnify any Nektar Party pursuant to Section 14.1, as to
which Loss each Party shall indemnify the other to the extent of their
respective liability for such Loss, (B) to the extent such Losses arise or
result from the [***] of an AstraZeneca Party, or the breach of any provision of
this Agreement or any Ancillary Agreement by AstraZeneca; and (C) to the extent
AstraZeneca has an obligation to indemnify a Nektar Party for any such Losses
pursuant to an Ancillary Agreement (which agreement shall set forth the
relationship between an indemnification obligation arising under this Agreement
and any indemnification obligation under such agreement).
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(b) (i)
the Exploitation of any Compound and any product containing any Compound by or
on behalf of Nektar or its Affiliates, licensees, or sublicensees (excluding
such Exploitation by AstraZeneca, its Affiliates, Distributors, and Sublicensees
as licensees and sublicensees of Nektar under this Agreement) (A) anywhere in
the world following termination of this Agreement in its entirety or (B) in one
or more countries following termination of this Agreement with respect to such
country(ies), in each case ((A) and (B)) including claims that arise from any
violation of Applicable Law in connection with such Exploitation or allege that
the claimant has suffered [***] as a result of the use of the Licensed Products
sold or distributed by or on behalf of Nektar or its Affiliates, licensees, or
sublicensees (excluding such sale or distribution by AstraZeneca, its
Affiliates, Distributors, and Sublicensees as licensees and sublicensees of
Nektar hereunder) as contemplated in (A) or (B) above; (ii) the exercise by
Nektar, its Affiliates, licensees, or sublicensees (excluding such exercise by
AstraZeneca, its Affiliates, Distributors, and Sublicensees as licensees and
sublicensees of Nektar hereunder) of rights under any license or right of
reference granted by AstraZeneca to Nektar under this Agreement or following or
in connection with termination of this Agreement in its entirety or with respect
to one or more country(ies), including pursuant to the Transition Agreement; or
(iii) the use by or on behalf of Nektar, its Affiliates, licensees, or
sublicensees (excluding such use by AstraZeneca, its Affiliates, Distributors,
and Sublicensees as licensees and sublicensees of Nektar hereunder) of the
Regulatory Documentation, Health Registration Approvals, Trademarks or other
Information transferred or made available by or on behalf of AstraZeneca or any
of its Affiliates to Nektar following or in connection with termination of this
Agreement in its entirety or with respect to one or more country(ies), including
pursuant to the Transition Agreement.
14.3. Notice of
Claim. An Indemnified Party shall give the Indemnifying Party
prompt written notice of any Loss or discovery of fact upon which such
Indemnified Party intends to base a request for indemnification under Section
14.1 or 14.2 (an “Indemnification Claim
Notice”). In no event shall the Indemnifying Party be liable
for any Loss that results from any delay in providing the Indemnification Claim
Notice. Each Indemnification Claim Notice shall contain a description
of the claim and the nature and amount of the Loss claimed (to the extent that
the nature and amount of such Loss is known at such time). The
Indemnified Party shall furnish promptly to the Indemnifying Party copies of all
papers and official documents received in respect of any such
Loss. For the avoidance of doubt, all indemnification claims in
respect of a Party, its Affiliates or its or their respective directors,
officers, employees and agents shall be made solely by such Party to this
Agreement.
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14.4. Indemnification
Procedures. The obligations of an Indemnifying Party under
this Article 14 shall be governed by and contingent upon the
following:
(a) Assumption of
Defense. The Indemnifying Party shall have the option to
assume the defense of any Third Party Claim by giving written notice to the
Indemnified Party within [***] after the Indemnifying Party’s receipt of an
Indemnification Claim Notice. The assumption of the defense of a
Third Party Claim by the Indemnifying Party shall not be construed as an
acknowledgment that the Indemnifying Party is liable to indemnify any
Indemnified Party in respect of the Third Party Claim, nor shall it constitute a
waiver by the Indemnifying Party of any defenses it may assert against any
Indemnified Party’s claim for indemnification. If the Indemnifying
Party does not assume the defense of a Third Party Claim, or fails to conduct
such defense, then the Indemnified Party may control the defense of such Third
Party Claim and shall have the rights under subsections (d) and (f) below, as
well as any other applicable rights under this Agreement.
(b) Control of
Defense. Upon the assumption of the defense of a Third Party
Claim by the Indemnifying Party:
(i) the
Indemnifying Party may appoint as lead counsel in the defense of the Third Party
Claim any legal counsel selected by the Indemnifying Party, which shall be
reasonably acceptable to the Indemnified Party, and
(ii) except as expressly provided
in Section 14.4(c), the Indemnifying Party shall not be liable to the
Indemnified Party for any legal expenses subsequently incurred by such
Indemnified Party in connection with the analysis, defense or settlement of the
Third Party Claim. In the event that it is ultimately determined that
the Indemnifying Party is not obligated to indemnify, defend or hold harmless an
Indemnified Party from and against the Third Party Claim, the Indemnified Party
shall reimburse the Indemnifying Party for any and all costs and expenses
(including lawyers’ fees and costs of suit) and any Loss incurred by the
Indemnifying Party in its defense of the Third Party Claim with respect to such
Indemnified Party.
(c) Right to Participate in
Defense. Without limiting Section 14.4(a) or 14.4(b), any
Indemnified Party shall be entitled to participate in, but not control, the
defense of a Third Party Claim and to retain counsel of its choice for such
purpose; provided, however, that such retention shall be at the Indemnified
Party’s own expense unless, (i) the Indemnifying Party has failed to assume the
defense and retain counsel in accordance with Section 14.4(a) (in which case the
Indemnified Party shall control the defense), or (ii) the interests of the
Indemnified Party and the Indemnifying Party with respect to such Third Party
Claim are sufficiently adverse to prohibit the representation by the same
counsel of both parties under Applicable Law, ethical rules or equitable
principles.
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(d)
Settlement and
Judgments. With respect to all Losses resulting from or
arising out of or in connection with Third Party Claims, where the Indemnifying
Party has assumed the defense of a Third Party Claim in accordance with Section
14.4(a), (i) the Indemnifying Party shall have authority to consent to the entry
of any judgment, enter into any settlement or otherwise dispose of such Losses,
provided that it obtains the prior written consent of the Indemnified Party ,
which consent shall not be unreasonably withheld and (ii) no
Indemnified Party shall admit any liability with respect to, or settle,
compromise or discharge, any such Third Party Claim without the prior written
consent of the Indemnifying Party, which consent shall not be unreasonably
withheld. With respect to all Losses resulting from or arising out of
or in connection with Third Party Claims, where the Indemnifying Party has not
assumed the defense of a Third Party Claim in accordance with Section 14.4(a),
the Indemnifying Party shall be responsible for all such Losses for which it has
indemnity and hold harmless obligations under Section 14.1 or Section 14.2, as
applicable, with respect to such Third Party Claim, provided that the Indemnified
Party shall not consent to the entry of any judgment, enter into any settlement
or otherwise dispose of such Losses, without first obtaining the prior written
consent of the Indemnifying Party, which consent shall not be unreasonably
withheld.
(e) Cooperation. To
the extent that the Indemnifying Party defends against any Third Party Claim,
the Indemnified Party that is a Party to this Agreement shall, and shall cause
each of its Affiliates and each of their respective directors, officers,
employees and agents to reasonably cooperate in the defense
or prosecution thereof and shall furnish such records, information and
testimony, provide such witnesses and attend such conferences, discovery
proceedings, hearings, trials and appeals as may be reasonably requested in
connection therewith. Such cooperation shall include access during
normal business hours by the Indemnifying Party to, and reasonable retention by
the Indemnified Party of, records and information that are reasonably relevant
to such Third Party Claim (subject to typical confidentiality protections), and
making the Indemnified Party, its Affiliates and its and their respective
directors, officers, employees and agents available on a mutually convenient
basis to provide additional information and explanation of any records or
information provided, and the Indemnifying Party shall reimburse the Indemnified
Party for all of its related reasonable out-of-pocket expenses.
(f)
Expenses. Except
as expressly provided above, the reasonable verifiable costs and expenses,
including fees and disbursements of counsel, incurred by the Indemnified Party
in connection with any Third Party Claim for which it is indemnified under this
Article 14, including all such costs and expenses incurred by Indemnified Party
with respect to defending a Third Party Claim for which the Indemnifying Party
did not assume the defense, shall be reimbursed on a Calendar Quarter basis by
the Indemnifying Party, which reimbursement shall be without prejudice to the
Indemnifying Party’s right to contest the Indemnified Party’s right to
indemnification and subject to refund in the event the Indemnifying Party is
ultimately held not to be obligated to indemnify the Indemnified Party under the
terms of this Article 14.
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14.5. LIMITATION ON
DAMAGES. EXCEPT IN CIRCUMSTANCES OF GROSS NEGLIGENCE OR
INTENTIONAL MISCONDUCT BY A PARTY OR ITS AFFILIATES, OR WITH RESPECT TO
INDEMNIFICATION OBLIGATIONS FOR THIRD PARTY CLAIMS UNDER SECTION 14.1 OR 14.2,
NEITHER PARTY OR ANY OF ITS AFFILIATES SHALL BE LIABLE TO THE OTHER (OR ANY OF
ITS AFFILIATES) FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, OR
FOR LOST PROFITS, LOST MILESTONES, OR LOST ROYALTIES, WHETHER IN CONTRACT,
WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE, ARISING OUT OF (a)
THE DEVELOPMENT, MANUFACTURE, USE OR SALE OF ANY LICENSED PRODUCT OR COMPOUND
DEVELOPED, MANUFACTURED OR MARKETED HEREUNDER OR UNDER ANY ANCILLARY AGREEMENT,
OR (b) ANY BREACH OF OR FAILURE TO PERFORM ANY OF THE PROVISIONS OF THIS
AGREEMENT OR ANY ANCILLARY AGREEMENT; PROVIDED, HOWEVER, THAT THE FOREGOING
LIMITATIONS SHALL NOT APPLY TO ANY LIABILITY OF EITHER PARTY FOR BREACH OF
ARTICLE 11.
14.6. Insurance. Each
Party shall have and maintain such type and amounts of liability insurance
covering the Manufacture, supply, use and sale of the Compounds and the Licensed
Products as is normal and customary in the pharmaceutical industry generally for
Persons similarly situated. Notwithstanding the foregoing, at a
minimum, Nektar shall maintain during any period in which Nektar has
indemnification obligations to AstraZeneca, which indemnification obligations
shall be scheduled in the policies, (a) commercial general liability insurance
with a combined single limit for bodily injury and property damage of not less
than [***], (b) products liability/completed operations coverage with a minimum
[***], and (c) an all-risks insurance policy covering its facilities with a
minimum [***]. Such policies shall (x) be provided by insurance
carrier(s) reasonably acceptable to AstraZeneca, (y) be written on an occurrence
or claims made basis, and (z) show AstraZeneca as additional insured and loss
payee, as its interests may appear, and provide that AstraZeneca will be given
[***] advance written notice of the termination thereof. Such
policies shall remain in effect throughout the Term and shall not be canceled or
subject to a reduction of coverage without the prior written authorization of
AstraZeneca. Should Nektar at any time or for any reason fail to
obtain the insurance required herein, or should such insurance be canceled or
the above limits reduced, AstraZeneca shall have the right to procure the same
and the cost and expense thereof shall be deducted from any compensation then
due or thereafter to become due to Nektar under this Agreement. All
such insurance will be written with a company or companies licensed to do
business in the State of New York having a financial rating of not less than A
‘X’ in the most current edition of Bests Key Rating
Guide. AstraZeneca shall have the right to satisfy the requirements
of this section through a program of self-insurance.
15.
Maintenance and Prosecution of Patents
15.1. Licensed
Patents.
(a) Control.
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(i) Designation of
Patents. Nektar shall notify the Patent Working Group promptly
following its becoming aware of any patentable Licensed Know-How
(A) Controlled by Nektar or its Affiliates [***] set forth on Exhibit B, or
(B) Controlled by Nektar or its Affiliates [***] (but that is [***]) ((A) and
(B), collectively, “New
Patentable Licensed Know-How”). Following such notification,
the Patent Working Group shall confer [***].
(ii) Licensed Product
Patents. Subject to the remainder of this Section 15.1,
including [***] to the Prosecution of Patents pursuant to Section 15.1(d) and
its rights under clause (iii) below with respect to the Nektar Technology,
AstraZeneca, in consultation with the Patent Working Group, shall have the
right, but not the obligation, to prepare, file, prosecute (including the
responsibility to conduct and manage any interferences, reissue proceedings,
oppositions and re-examinations), and maintain (collectively, “Prosecute” or “Prosecution”) the Licensed
Product Patents, other than the Nektar Technology Within LPP Patents (which are
the subject of clause (iii) below), throughout the Territory, at AstraZeneca’s
expense.
(iii) Nektar Technology Within the
LPP Patents. It is understood and agreed between the Parties
that the Licensed Product Patents may disclose [***] (“Nektar Technology Within LPP
Patents”). [***].
(iv) Nektar Technology
Patents. Subject to the remainder of this Section 15.1
including [***] to the Prosecution of Patents pursuant to Section 15.1(d),
Nektar shall, in consultation with the Patent Working Group to the extent the
Prosecution involves claims that relate to the Exploitation of NKTR-118 or any
other known Compound or any then-existing Licensed Product, including the Lead
Product, or an Opioid Combination Product, [***].
(v) Costs and Conduct of
Prosecution. Except as set forth in clause (vi), the
Prosecuting Party with respect to any Licensed Patents as described in clauses
(ii) - (iv) above shall conduct such Prosecution using in-house patent counsel
or agents or outside patent counsel or agents of the Prosecuting Party’s
choosing (subject, in the case of outside patent counsel or agents, to the prior
written consent of the non-Prosecuting Party, such consent not to be
unreasonably withheld), and all expenses and costs of such Prosecution
(including, for example, maintenance fees, attorney fees, filing fees and
translations) directed by the Prosecuting Party shall be paid by and are the
sole responsibility of the Prosecuting Party.
(vi) Simultaneous
Prosecution. Notwithstanding anything to the contrary in this
Section 15.1, in the event that, with respect to a [***] within the Licensed
Product Patents, a Party has Prosecution rights that [***], then (A) such
Prosecution shall be conducted by the [***] selected by mutual agreement of the
Parties in writing, such agreement not to be unreasonably withheld or delayed by
either Party, and (B) the Parties shall cooperate to [***] in the Prosecution of
such Patent Family.
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(b)
Prosecution
Activities.
(i) With
respect to a given Licensed Patent, the Prosecuting Party with respect thereto
shall, unless and until such Party informs the other Party that it elects not to
pursue or continue the Prosecution of a Licensed Patent in a given country:
(A) file and prosecute Patent applications to secure Patent rights for such
Licensed Patent [***] in the [***] and [***] and such other countries as
mutually agreed by AstraZeneca and Nektar (and such other countries as such
Prosecuting Party elects); and (B) consult with the other Party (through its
representatives on the Patent Working Group) regarding such Prosecution efforts
(to the extent required by subsection (a) above), by providing such other Party
a reasonable opportunity to review and participate in such Prosecution efforts
regarding the applicable Patent Rights, including by providing to the Patent
Working Group copies of all material communications from any patent authority in
the Territory regarding such patent applications, and by providing drafts of any
responses and any material filings to be made to such patent authorities
reasonably in advance of submitting such responses or filings, and reasonably
discussing any comments made by the other Party regarding such Prosecution
efforts and in good faith seeking to accommodate all reasonable comments made by
the other Party, and (C) upon issuance, maintain such Licensed Patent
[***].
(ii) [***].
(c) Disputes. If,
following consideration by the Patent Working Group, the Parties disagree with
respect to the Prosecution of any Licensed Patents, [***].
(d) Election not to
Prosecute. If the Prosecuting Party elects not to pursue or
continue the Prosecution of a Licensed Patent in a particular country, the
Prosecuting Party shall so notify the non-Prosecuting Party promptly in writing
[***]. Upon receipt of any such notice, or if at any time the
Prosecuting Party fails within [***] to Prosecute a Licensed Patent that the
non-Prosecuting Party has requested that the Prosecuting Party Prosecute, or if
after initiating such requested Prosecution the Prosecuting Party at any time
thereafter fails to [***], then [***] the non-Prosecuting Party shall have the
right, but not the obligation, to pursue the Prosecution of such Patent at its
expense in such country, [***].
15.2. Cooperation. Each
Party shall, and shall cause its Affiliates to, assist and cooperate with the
other Party, as such other Party may reasonably request from time to time in
connection with its activities under Section 15.1. Without limitation
of Section 15.1, the Prosecuting Party shall keep the Patent Working Group
currently informed of all steps to be taken in the preparation and prosecution
of all applications filed by such Party in its capacity as the Prosecuting Party
according to Section 15.1 and shall furnish the non-Prosecuting Party (through
its members on the Patent Working Group) with copies of such applications for
Patents, amendments thereto and other related correspondence to and from patent
offices, in each case in sufficient time to permit the non-Prosecuting Party the
opportunity to exercise its rights pursuant to Section 15.1 before the
Prosecuting Party makes a submission to a patent office which could materially
affect the scope or validity of the patent coverage that may
result. The non-Prosecuting Party shall offer its comments, if any,
promptly.
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15.3. Joint
Patents.
(a) AstraZeneca
shall have the first right but not the obligation at its expense, through
counsel or agents of its choosing, to Prosecute (including the right to manage
any interferences, reissue proceedings and re-examinations) the Joint Patents
throughout the world. Except with respect to any Joint Patent in any
country with respect to which AstraZeneca has relinquished Prosecution pursuant
to Section 15.3(b), AstraZeneca shall have the sole right to determine in which
countries to obtain, Prosecute and maintain the Joint Patents.
(b) If
AstraZeneca elects not to pursue or continue the Prosecution of a Joint Patent
in a particular country, AstraZeneca shall so notify Nektar promptly in writing
at least thirty (30) days prior to any deadlines by which an action must be
taken to establish or preserve all rights under such Joint Patent in such
country; [***]. Upon receipt of any such notice, or if at any time
AstraZeneca fails within [***] to Prosecute a Joint Patent that Nektar has
requested that AstraZeneca Prosecute, or if after initiating such requested
Prosecution the Prosecuting Party at any time thereafter fails to [***], then
(subject to the foregoing proviso) Nektar shall have the right, but not the
obligation, to pursue the Prosecution of such Joint Patent, at its sole expense,
in such country, on behalf of both Parties. [***].
(c) The
Party Prosecuting any Joint Patent shall keep the other Party currently informed
(through its representative on the Patent Working Group) of all steps to be
taken in the Prosecution of such Joint Patent in such country and shall furnish
the Patent Working Group with copies of such applications for such Joint Patent
in such country, any amendments thereto and any other related material
correspondence to and from patent offices with respect to such Joint Patent in
such country.
(d) AstraZeneca
and Nektar shall, and shall cause their respective Affiliates, as applicable, to
assist and cooperate with one another in Prosecuting the Joint
Patents. The Prosecuting Party shall reimburse the other Party for
its external, out-of-pocket costs associated with such assistance and
cooperation.
15.4. CREATE
Act. Notwithstanding anything to the contrary in this Article
15, neither Party shall have the right to make an election under the Cooperative
Research and Technology Enhancement Act of 2004, 35 U.S.C.
103(c)(2)-(c)(3) (the “CREATE
Act”) when exercising its rights under this Article 15 without the
prior written consent of the other Party, not to be unreasonably
withheld. With respect to any such permitted election, the Parties
shall use reasonable efforts to cooperate and coordinate their activities with
respect to any submissions, filings or other activities in support
thereof. The Parties acknowledge and agree that this Agreement is a
“joint research agreement” as defined in the CREATE Act.
15.5. Patent Term
Extensions. AstraZeneca shall have the sole right to make all
decisions regarding patent term extensions for the Licensed Patents and the
Joint Patents worldwide, including (a) in the United States with respect to
extensions pursuant to 35 U.S.C. § 156 et. seq., (b) in other
jurisdictions pursuant to supplementary protection certificates, and (c) in
all jurisdictions with respect to any other extensions that are now or become
available in the future. Upon request by AstraZeneca, Nektar shall
reasonably cooperate, at AstraZeneca’s expense, in the implementation of
AstraZeneca’s decisions under this Section 15.5.
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15.6. Orange Book
Listings.
(a) Designation of Listable
Patents. Upon the issuance of any Licensed Patent, the
Prosecuting Party shall inform the Patent Working Group. AstraZeneca,
through its representative(s) on the Patent Working Group, may designate, in
good faith, any Licensed Patent as an “Orange Book Listable Patent”
on the basis that such Licensed Patent may be [***] for a Licensed Product;
[***].
(b) Listing of
Patents. AstraZeneca shall have the sole right to make all
filings with the Health Authorities with respect to Licensed Patents and Joint
Patents in connection with required regulatory activities for Licensed Products,
including as required or allowed in connection with: (i) in the
United States, the FDA’s Orange Book and (ii) outside the United States, under
the national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or
other international equivalents (any of the foregoing ((i), (ii) or
international equivalents of (i) or (ii)), a “Patent Exclusivity
List”). Nektar shall, at AstraZeneca’s expense, (A) provide to
AstraZeneca all Information, including a correct and complete list of Licensed
Patents covering any Licensed Product or otherwise necessary or reasonably
useful to enable AstraZeneca to make such filings with Health Authorities with
respect to the Licensed Patents, and (B) cooperate with AstraZeneca’s reasonable
requests in connection therewith, including meeting any submission deadlines, in
each case, to extent required or permitted by Applicable
Law. AstraZeneca shall notify Nektar in writing of any such filings
with the Health Authorities with respect to the Licensed Patents or the Joint
Patents.
16.
Enforcement of Patents
16.1. Notice of
Infringement. If either Party believes that a Third Party is
infringing any of the Licensed Patents or Joint Patents (“Third Party Infringing Activities”), such
Party shall promptly notify the other Party in writing, identifying the alleged
infringer and the alleged infringement complained of and furnishing the
information upon which such determination is based.
16.2. Control of
Enforcement.
(a) Nektar Technology
Patents. Subject to each Party’s [***] pursuant to Section
16.3 (if applicable), if any Third Party Infringing Activity infringes the
Nektar Technology Patents, then if such Third Party Infringing Activity relates
to (i) indications other than the [***] (such Third Party Infringing Activity, a
“[***]”), Nektar shall have the first right, but not the obligation, through
counsel of its choosing, to take any measures it deems appropriate to stop such
Third Party Infringing Activity or to grant to the infringing Third Party
adequate rights and licenses under the Nektar Technology Patents necessary for
continuing such activities [***] or (ii) the [***], AstraZeneca shall have the
first right, but not the obligation, through counsel of its choosing (such Third
Party Infringing Activity, “[***]”), to take any measures it deems appropriate
to stop such Third Party [***] Activity or to grant to the infringing Third
Party adequate rights and licenses under the Nektar Technology Patents [***] for
continuing such activities (but, in the case of a grant of such rights and
licenses, solely to the extent that AstraZeneca has such rights and licenses
under this Agreement). [***].
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(b) Relating to the Licensed
Product Patents and Joint Patents. Subject to [***] pursuant
to Section 16.3 and to the obligations under Section 16.5, for any Third Party
Infringing Activities that comprise the infringement of Licensed Product Patents
or Joint Patents, AstraZeneca shall have the first right, through counsel of its
choosing, to take any measures it deems appropriate to stop such Third Party
Infringing Activities or to grant to the infringing Third Party adequate rights
and (sub)licenses necessary for continuing such activities (but, in
the case of a grant of such rights and licenses, solely to the extent that
AstraZeneca has such rights and licenses under this Agreement).
16.3. [***].
(a) With
respect to any Third Party Infringing Activities, and subject to the other
provisions of this Article 16, if the Party with the first right to enforce a
Patent pursuant to Section 16.2(a) or (b) (the “First Enforcing Party”) (i)
does not [***] following notice of such Third Party Infringing Activities
commence taking commercially appropriate steps to [***] of the applicable
Licensed Patent or Joint Patent that is likely to have a [***] on the sale of
Licensed Products (or earlier notifies the other Party (the “Second Enforcing Party”) in
writing of its intent not to take such steps), and (ii) the First Enforcing
Party has not granted the infringing Third Party rights and licenses to continue
the activities, then the Second Enforcing Party shall have the right, following
written notification to the First Enforcing Party, to take actions to cause
[***] expense [***].
(b) [***].
16.4. ANDA
Act. Notwithstanding the foregoing, Nektar shall [***] advise
AstraZeneca of receipt of any notice of (a) any certification filed under the US
“Drug Price Competition and Patent Term Restoration Act” of 1984 (21 United
States Code §355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV)), as amended or supplemented
(or any successor law) (“ANDA
ACT”) claiming that any Licensed Patent or Joint Patent is invalid or
unenforceable or claiming that any Licensed Patent or Joint Patent will not be
infringed by the Manufacture, use, marketing, or sale of a product for which an
application under the ANDA ACT is filed, or (b) any equivalent or similar
certification or notice in any other
jurisdiction. [***].
16.5. Cooperation. Upon
reasonable request by the Party (the “Enforcing Party”) taking any
legal action permitted under this Article 16 with respect to enforcing
applicable Licensed Patents against Third Party Infringing Activities under this
Article 16, the other Party shall give the Enforcing Party all reasonable
information and assistance, including allowing the Enforcing Party reasonable
access to its files and documents and personnel who may have possession of
relevant information. If necessary for AstraZeneca to prosecute any
legal action, upon AstraZeneca’s request Nektar shall join, or shall ensure that
its applicable Affiliate joins, in the legal action as a
party. [***].
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16.6. Participation. The
Party that is not the Enforcing Party shall have the right to participate in
(but not control), at its sole cost and expense through counsel of its choosing,
any enforcement action with respect to Field Infringement or, in the case of
Nektar as the non-Enforcing Party, Non-Field Infringement.
16.7. RecoveryAny amounts
recovered by either Party with respect to Field Infringement, or, in the case of
AstraZeneca as the enforcing Party, infringement by a [***]. Pursuant to this
Article 16, whether by settlement or judgment, shall be [***] the Parties for
their [***] in making such [***] (which amounts shall be allocated [***] if
insufficient to cover the [***]), with any [***] being allocated between the
Parties as follows: (a) if recovered by Nektar, [***]; and (b) if
recovered by AstraZeneca, [***].
17. Potential
Third Party Actions
17.1. Third Party
Licenses. If, in the good faith opinion of AstraZeneca, a
license to a Patent or other Intellectual Property Right Controlled by a Third
Party [***].
17.2. Invalidity or
Unenforceability Defenses or Actions.
(a) Notice. If
a Third Party asserts that any Licensed Patent or Joint Patent is invalid or
unenforceable, whether as a defense or as a counterclaim in a legal action
(whether such legal action is brought by a Party or its Affiliate with respect
to Third Party Infringing Activities, with respect to an ANDA Act or equivalent
certification under Article 17, or any other action) or in a declaratory
judgment action or similar action or claim (any such defense, counterclaim,
claim, or action, an “Invalidity Action”), then the
Party first becoming aware of the Invalidity Action shall promptly give written
notice to the other Party.
(b) [***].
17.3. Third Party
Litigation. In the event of any actual or threatened suit
against Nektar or its Affiliates, AstraZeneca or its Affiliates, Sublicensees,
Distributors or customers alleging that the Exploitation of Compounds or
Licensed Products infringes the Patent or Intellectual Property Rights of any
Third Party (an “Infringement
Suit”), the Party first becoming aware of such Infringement Suit shall
promptly give written notice to the other Party. [***].
17.4. Cooperation. Nektar
will provide to AstraZeneca, [***], all reasonable assistance requested by
AstraZeneca in connection with any action, claim or suit under Section 17.2
or 17.3, including allowing AstraZeneca reasonable access to Nektar’s files and
documents related to such action, and to Nektar’s personnel who likely have
possession of relevant information, [***] to respond to or defend against the
applicable actions or claims. In particular Nektar will promptly make
available to AstraZeneca, at AstraZeneca’s expense, all Information in its
Control that [***] AstraZeneca in responding to any such action, claim or suit
under Section 17.2 or 17.3. [***].
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17.5. Costs and
Expenses. [***].
18.
Term and Termination
18.1. HSR and Other Governmental
Filings. The Parties shall each, as promptly as practicable
after the Execution Date, file or cause to be filed with the U.S. Federal Trade
Commission and the U.S. Department of Justice and any relevant foreign
governmental authority any notifications required to be filed under the HSR Act
(the “HSR Filing”) or
any similar applicable foreign law or regulation with respect to the
transactions contemplated hereby; provided that the
Parties shall each make the HSR Filing within [***] after the Execution Date and
shall each file any notifications or filings required to be filed under similar
applicable foreign laws and regulations as promptly as reasonably
practicable. The Parties shall use their [***] to respond promptly to
any requests for additional information made by such agencies, and to cause the
waiting period (and any extension thereof) under the HSR Act or any similar
applicable foreign law or regulation to [***] after the date of
filing. Each Party is responsible for its own filing fees and for the
costs and expenses of its own legal and other advice in preparing and conducting
the HSR Filing.
18.2. Term. Notwithstanding
anything in this Agreement to the contrary, this Agreement (other than this
Section 18, which is binding and effective as of the Execution Date) shall not
become effective until the expiration or earlier termination of the waiting
period (or any extension thereof) under the HSR Act in the United States (the
date of such expiration or earlier termination, the “Effective Date”), and upon the
Effective Date the full Agreement and all its terms and provisions shall be
automatically effective and binding on both Parties. If, on the [***]
after the date of filing under the HSR Act the waiting period required
thereunder has not expired, [***] shall have the right, on written notice [***],
and upon receipt of such notice by such other Party, this Agreement shall be
null and void and have no further force and effect. The term of this
Agreement shall become effective as of the Effective Date and shall continue
until (a) expiration, which shall occur automatically upon the expiry of the
exclusivity of AstraZeneca’s license rights with respect to all Licensed
Products in the Territory, as provided in Section 4.7, or (b) earlier terminated
in accordance with this Article 18 (the “Term”).
18.3. Termination for
[***].
(a) If,
in the [***], the Exploitation of NKTR-118 or the Lead Product by AstraZeneca,
its Affiliates or any of their Sublicensees [***]prior written notice to Nektar,
to terminate this Agreement with respect to such country if at any time (i)
AstraZeneca is [***] or (ii) AstraZeneca [***], provided, however, that
AstraZeneca shall have (x) first notified Nektar of [***] and afforded Nektar a
[***] period (or longer, if elected by AstraZeneca) in which Nektar shall have
the opportunity to discuss such [***] with AstraZeneca in good faith, and (y) if
Nektar provides any [***] to AstraZeneca during such period regarding [***],
AstraZeneca shall consider such [***]. If AstraZeneca has delivered a
termination notice to Nektar under this Section 18.3(a), AstraZeneca shall have
the right to cease conducting any further activities under this Agreement [***]
(subject only to compliance with Applicable Laws and ethical
obligations). If (A) AstraZeneca has the right to terminate this
Agreement pursuant to this Section 18.3(a) with respect a country in [***],
AstraZeneca shall have, subject to compliance with all the foregoing, the right
to terminate this Agreement with respect to [***], and (B) AstraZeneca has the
right to terminate this Agreement pursuant to this Section 18.3(a) with respect
to the [***] or a [***], AstraZeneca shall have the right to terminate
[***].
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(b) If
[***] with respect to [***] or the [***] in a country, AstraZeneca shall have
the right upon [***] prior written notice to Nektar to [***] if (i) within
[***], and (ii) [***]. In such case, AstraZeneca shall have the right
to cease conducting the activities that [***] (subject only to compliance with
Applicable Laws and ethical obligations). If (A) AstraZeneca has the
right to terminate this Agreement pursuant to this Section 18.3(b) with respect
a country in [***], AstraZeneca shall have, subject to compliance with all the
foregoing, the right to terminate this Agreement with respect to [***], and (B)
AstraZeneca has the right to terminate this Agreement pursuant to this Section
18.3(b) with respect to the [***] or a [***], AstraZeneca shall have the right
to terminate [***].
18.4. Termination by AstraZeneca
[***].
(a) Termination [***] in the
Territory. AstraZeneca may terminate this Agreement in its
entirety [***] of a Licensed Product in the Territory pursuant to this Section
18.4(a) [***] (a) a Health Authority notifies AstraZeneca, or AstraZeneca
determines in good faith, in accordance with and based on its [***], that there
is a [***] regarding (i) the Lead Product or (ii) any Licensed Product
containing NKTR-118 such that [***] (a “[***]”), (b) the Lead Product does not
meet the [***] (“[***]”), or (c) (i) following the [***], based on such
meeting and any other guidance provided by the FDA, AstraZeneca reasonably
determines that [***], or (ii) for the period following the adoption of the
Development Plan, the FDA or EMEA requires that, or provides guidance that
AstraZeneca [***], or the FDA or EMEA modifies the requirements for obtaining
such a Health Registration Approval (e.g., any modification of the required
[***]) which modifications will [***]in seeking [***] (a “[***]”). If
AstraZeneca is entitled to terminate this Agreement pursuant to the immediately
preceding sentence, AstraZeneca shall have the right to cease conducting any
further activities under this Agreement with respect to development of Licensed
Product (subject only to compliance with Applicable Laws and ethical
obligations). In order to terminate this Agreement pursuant to this
Section 18.4(a), in the case of a [***], AstraZeneca shall provide Nektar [***]
prior written notice. In order to terminate this Agreement pursuant
to this Section 18.4(a), in the case of a [***], AstraZeneca may terminate this
Agreement [***] upon written notice to Nektar for a [***]; provided that if
AstraZeneca has completed at least [***] and has ceased all development,
regulatory and other activities with respect to the Licensed Products under this
Agreement (or, in its sole discretion, is able to [***]), AstraZeneca shall not
[***], AstraZeneca may, in its sole discretion, [***] with respect to the
Compounds and Licensed Products and any and all of AstraZeneca’s diligence
obligations hereunder shall be suspended during the [***] and any obligation of
AstraZeneca to make any milestone payment hereunder shall be suspended during
the [***]. Further, AstraZeneca shall have no obligation during the
[***] or any termination notice period to take any action with respect the
Licensed Products or the Licensed Patents that would require AstraZeneca to
[***]. In the event that AstraZeneca does not provide a notice of
termination under this Section 18.4(a) [***], such diligence obligations and
milestone payment obligations shall recommence. In the event this
Agreement is terminated by AstraZeneca under this Section 18.4(a) [***], any
[***] that was suspended during the Review Period shall not be due from
AstraZeneca.
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(b) Termination [***] in the
Territory. AstraZeneca may terminate the Agreement in its
entirety following the [***] of a Licensed Product in the Territory pursuant to
this Section 18.4(b) [***] if there is a [***] or a [***]. If
AstraZeneca is entitled to terminate this Agreement pursuant to the immediately
preceding sentence, AstraZeneca shall have the right to do so effective (i)
[***] upon written notice to Nektar for a [***] or (ii) on [***] prior written
notice to Nektar for a [***].
18.5. Termination for Material
Breach. A termination by AstraZeneca pursuant to this Section
18.5 shall be a “Termination by
AstraZeneca for Material Breach,” and a termination by Nektar pursuant to
this Section 18.5 shall be a “Termination by Nektar for Material
Breach.”
(a) Termination for Breach Not
Related to Diligence. If either Party (the “Breaching Party”) is in
material breach of this Agreement (except for AstraZeneca’s diligence
obligations under Section 6.3 or Section 6.4, which is covered in subsection (b)
below), in addition to any other right or remedy the other Party (the “Complaining Party”) may have,
the Complaining Party may terminate this Agreement (which termination may be
limited to specific with respect to the country or countries to which such
material breach applies, if applicable, as provided below) by providing the
Breaching Party notice specifying the breach and an opportunity to cure such
breach in accordance with this Section 18.5(a). The Complaining Party
shall provide written notice (the “Termination Notice”) to the
Breaching Party, specifying the breach and its claim of right to
terminate. The Breaching Party shall have [***] from receiving such
notice to cure the breach (or, if such breach cannot be cured within such
period, and if the Breaching Party commences good faith, diligent actions to
cure such breach within such [***] period, such longer period as the Breaching
Party is thereafter diligently continuing such good faith actions to cure the
breach as soon as possible, such longer period not to exceed an additional [***]
(the “Cure Period”), and
provided that
the Cure Period for payment breaches shall be [***] from the date of notice (and
shall not, for clarity, be subject to any extension of the Cure Period under the
foregoing). If the breach is not cured within the Cure Period, the
Termination Notice shall become effective [***] following the expiration of the
Cure Period (unless the Complaining Party waives termination in writing prior
thereto). If AstraZeneca is the Complaining Party, then during the
Cure Period after its Termination Notice to Nektar, any obligation of
AstraZeneca to make any milestone payment hereunder shall be
suspended. In the event AstraZeneca terminates this Agreement in its
entirety under this Section 18.5(a) due to the uncured material breach of
Nektar, then any milestone obligation that was so suspended shall not be due
from AstraZeneca. If, on the other hand, Nektar cures the breach that
was the subject of the Termination Notice, or the Parties otherwise agree that
the Agreement shall not be terminated despite such Termination Notice, such
suspended milestone payments shall then be paid by AstraZeneca to Nektar (except
as otherwise agreed by the Parties in writing in connection with the resolution
of such issue). If the material breach of a Breaching Party relates
solely and exclusively to a particular country or countries, then a Complaining
Party shall have the right to terminate this Agreement solely as to such country
or countries if Breaching Party does not cure the breach by the end of the Cure
Period. For clarity, breach of payment obligations shall not be
considered solely and exclusively relating to a particular country or
countries.
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(b) Termination for Breach of
Diligence Obligations. If at any time Nektar believes that
AstraZeneca is in material breach of its diligence obligations under Section 6.3
or Section 6.4, then Nektar shall so notify AstraZeneca, specifying the basis
for its belief, and the Parties shall meet within [***] after such notice to
discuss [***]. If, after such [***] period, the Parties do not reach
agreement as to whether or not AstraZeneca is in material breach of such
obligations and resolve the issue, then either Party may require that the issue
be resolved by the matter being referred to expedited arbitration in accordance
with Section 19.3 hereof (which arbitration shall determine whether AstraZeneca
is in material breach of such obligations and, if so, what steps must be taken
to cure such material breach). If the arbitrators in such arbitration
determine that AstraZeneca is in material breach of its obligations under
Section 6.3 or 6.4, then (i) the arbitrators shall specify the [***] in order to
cure such breach; (ii) AstraZeneca shall [***] of such arbitration (including
[***] and other similar [***]), and (iii) AstraZeneca shall have the right to
cure such breach by [***], within [***] frame. If AstraZeneca does
not [***], then Nektar may [***] respect to the [***] to which the material
breach [***] (provided that if such
termination is with respect to any [***], it shall be with respect to
[***]). Further, if under any such arbitration the arbitrators
determined that AstraZeneca materially breached its obligations in a [***], then
if Nektar [***] of the most [***] under this subsection (b) with respect to any
such country, based on its belief that AstraZeneca has [***] its obligations
under Section 6.3 or 6.4 with respect to such country, and the arbitrators in
such arbitration rule that AstraZeneca did materially breach such obligations
with respect to such [***], then Nektar may terminate this Agreement with
respect to such [***] (without any opportunity of AstraZeneca to then cure the
breach).
18.6. Rights and Obligations
Following Termination.
(a) Following Termination of
Agreement in Entirety. If this Agreement is terminated in its
entirety, all rights and licenses granted to AstraZeneca under this Agreement
shall terminate and revert exclusively to Nektar, except as otherwise expressly
stated in this Article 18. For [***] after such termination, other
than as expressly permitted under this Agreement or the Transition Agreement,
AstraZeneca covenants that it and its Affiliates shall not [***] that are in
[***] or are [***] immediately prior to such termination; provided that the
foregoing shall not apply to any Licensed Product on or after the date on which
there is first a [***] on the market in the [***] with respect to such Licensed
Product.
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(b) Following Termination with
Respect to a [***]. If this Agreement is terminated with
respect to [***] (but not in its entirety) (each terminated country, a “Terminated Country” and each
other country, a “Non-Terminated
Country”):
(i) the
rights and licenses granted to AstraZeneca in Section 4.1 with respect to the
[***] shall automatically terminate and revert exclusively to Nektar, except
that limited license rights shall remain in effect in the [***] solely for the
limited purpose of allowing AstraZeneca (A) to [***] of the Compounds and the
Licensed Products in the [***] in order to [***] in the Non-Terminated Countries
and (B) to [***] the Licensed Products (including the Compounds therein) in the
[***] for [***] thereof in the Non-Terminated Countries, and correspondingly the
sublicense rights granted to AstraZeneca in Section 4.2 shall remain in effect
solely to allow AstraZeneca to [***] under such rights and licenses solely for
the aforesaid purpose;
(ii) the
rights and licenses granted to AstraZeneca under Sections 4.3, and 4.4 shall
survive termination solely with respect to the Non-Terminated Countries, but
such license rights shall be subject to [***] the Compounds and Licensed
Products in the Non-Terminated Countries solely for seeking [***];
and
(iii) Section
4.5(c) shall, if still in effect, continue (for the period set forth in Section
4.5(c)) to be binding on each Party only with respect to [***] in the
Non-Terminated Countries.
18.7. Termination for [***]. If AstraZeneca or
its Affiliate [***] that any Licensed Product Patent is [***], or, in [***],
otherwise [***] of a Licensed Product Patent, then Nektar may terminate the
Agreement on [***] written notice.
18.8. Assignment of Product
Trademark. In the event of termination of this Agreement in
its entirety other than a Termination by AstraZeneca for Material Breach,
AstraZeneca shall and hereby does assign, at its cost, and shall cause its
Affiliate (as applicable) to assign to Nektar, effective as of the effective
date of termination of this Agreement, all of its (or its Affiliate’s) rights,
title and interests in and to any Trademarks used publicly by AstraZeneca
exclusively in connection with the commercialization of the Existing Reversion
Products at the time of such termination and all relevant applications and
registrations, and all Intellectual Property Rights and other rights and
goodwill with respect thereto. Each Party shall execute and deliver
or shall cause its Affiliates (as applicable) to execute and deliver to the
other Party all documents that are necessary to fulfill the obligations set
forth in this Section 18.8.
18.9. Other Termination
Consequences. The consequences set forth in this Section 18.9
shall apply solely on and after the effective date of the termination of this
Agreement in its entirety or with respect to one or more countries, as
applicable.
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(a) Return of Proprietary
Information. In the event of termination of this Agreement,
each Party shall return all data, files, records and other materials in its
possession or control containing or comprising the other Party’s Information or
other Confidential Information (in the event of termination of this Agreement
with respect to one or more countries but not in its entirety, solely to the
extent relating to Terminated Countries but not other countries) to which such
first Party does not retain rights under the surviving provisions of this
Agreement (except one copy of which may be retained solely for archival
purposes). Upon the effective date of such termination, Restricted
Information that AstraZeneca is required to return pursuant to the preceding
sentence shall be deemed Confidential Information only of Nektar. For
the avoidance of doubt, in the event of termination of this Agreement with
respect to one or more countries (but not in its entirety), AstraZeneca shall
have the right to retain all such Information, including Confidential
Information, that is necessary or useful for AstraZeneca to Exploit Licensed
Products with respect to Non-Terminated Countries.
(b) Access to Data; Right of
Reference. In the event of termination of this Agreement with
respect to one or more countries or in its entirety (other than Termination by
AstraZeneca for Material Breach), in addition to Nektar’s rights elsewhere in
this Agreement (including without limitation Section 18.12(c)), AstraZeneca and
its Affiliates shall disclose and transfer to Nektar copies of all clinical data
of AstraZeneca and its Affiliates relating to Existing Reversion Products and
reasonably needed to Exploit the Existing Reversion Products, and automatically
grants to Nektar, effective as of the effective date of any such termination of
this Agreement, a right to use such clinical data for all purposes related to
Licensed Products (such rights limited to the Terminated Countries if
termination is limited to certain countries), and a right of reference (which
rights is fully transferable to other parties, with AstraZeneca agreeing to
provide any needed letters acknowledging such right of reference as needed by
any transferee) to all Regulatory Documentation (excluding Regulatory
Documentation solely relating to Licensed Products other than Existing Reversion
Products) that AstraZeneca and its Affiliates own and as to which neither
AstraZeneca nor any of its Affiliates has any obligations, financial or
otherwise, to a Third Party to the extent necessary for Nektar to Exploit
Existing Reversion Products (in the event of termination of this Agreement with
respect to one or more countries (but not in its entirety), solely in the
Terminated Countries). Nektar shall be able to exercise such rights
(on a non-exclusive basis if termination is limited to certain countries) but
only to the extent [***] to enable Nektar (and its Affiliates and licensees) to
continue Exploitation of Licensed Products with respect to the Terminated
Countries (or, if applicable, the Territory).
(c) Safety
Reporting. If this Agreement is terminated with respect to one
or more countries, but not in its entirety, then promptly following the
effective date of termination the Parties shall enter into an agreement (or an
amendment to the Safety Agreement) governing the Parties’ respective rights and
responsibilities with respect to the coordination of safety-related regulatory
obligations, including the reporting of Adverse Events and other safety or
quality data. Such agreement shall set forth terms and conditions
with respect to such activities that are reasonable and customary in the
industry for agreements of that nature.
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18.10. No Adverse
Impact. If this Agreement is terminated with respect to one or
more countries, but not in its entirety, then this Section 18.10 shall apply for
so long as both Parties are developing or commercializing Licensed Products in
one or more countries. On a [***] basis, each Party shall provide the
other Party with a [***], including all [***], with respect to Licensed Products
for the upcoming [***] in sufficient detail to permit the other Party to assess
whether such activities could adversely affect the [***] of the Licensed
Products in the countries where such Party has the right to commercialize the
Licensed Products. Further, each Party shall provide reasonable
advance notice prior to [***] respect to Licensed Products. If a
Party notifies the other Party in writing, prior to the commencement of such
[***], that it believes in good faith that such [***] would likely adversely
impact the [***] of any Licensed Product in the countries in which the other
Party has the right to commercialize Licensed Product, then the Parties shall
discuss such matter in good faith and the Party planning to conduct in the [***]
shall consider the other Party’s concerns in good faith. If such
first Party does not address such concerns and does not have the right to
commercialize the Licensed Products in either the [***] or the [***], and the
other Party has the right to commercialize the Licensed Products in the [***]
and the [***], then such first Party shall not commence such [***] without the
consent of such other Party, such consent not to be unreasonably withheld or
delayed.
18.11. Nektar
Responsibilities. Following termination of this Agreement
(other than a Termination by AstraZeneca for Material Breach), Nektar shall
comply with the applicable obligations in any agreement, [***], between
AstraZeneca or its Affiliate or its Sublicensee and a Third Party pursuant to
which AstraZeneca or its Affiliate or Sublicensee Controls (a) any [***] under
which a license is granted pursuant to [***], (b) any [***] transferred pursuant
to [***], or (c) any [***] that is transferred or to which Nektar has a [***]
(such agreements, collectively, “Post-Termination Control
Agreements”), [***] in any agreement that [***] (and provided that Nektar
shall, based on such rejection, not have license rights to any such [***] that
AstraZeneca Controls solely under the terms of such rejected
agreements). Following the effective date of such a termination,
Nektar shall be responsible for any payments owed by AstraZeneca or its
Affiliates or Sublicensees under any Post-Termination Control Agreement arising
as a result of or in connection with any Exploitation of Licensed Products by or
on behalf of Nektar or its Affiliates or licensees or sublicensees (excluding
AstraZeneca and its Affiliates and Sublicensees), including in connection with
its or their Exploitation of any [***] to which Nektar obtains rights under this
Article 18.
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18.12. Transition
Agreement. In the event of termination of this Agreement
(other than a Termination by AstraZeneca for Material Breach), whether in its
entirety, with respect to one or more countries, Nektar and AstraZeneca shall
negotiate in good faith the terms and conditions of a written transition
agreement (the “Transition
Agreement”) pursuant to which AstraZeneca and Nektar will effectuate and
coordinate a smooth and efficient transition of relevant obligations and rights
to Nektar as reasonably necessary for Nektar to Exploit the Existing Reversion
Products after termination of this Agreement (in its entirety or with respect to
one or more country(ies)). Such Transition Agreement shall provide
that (x) in the event Nektar’s or its Affiliates’ practice of any [***] or used
of any [***] would [***] to a Third Party based on such use or practice with
respect to one or more Licensed Products, then Nektar may [***] from the scope
of the rights granted under the Transition Agreement or Nektar shall be solely
responsible for [***], (y) [***], in consideration for AstraZeneca’s investments
in and funding of the Licensed Products, the transfer and assignment, or license
(as applicable), of the [***] and, if applicable, the [***] and other [***] and
agreements as provided below, [***] (provided that, for
purposes of this Section 18.12, references to AstraZeneca in such definition
shall be deemed to be references to Nektar) of each Reversion Product Exploited
by or on behalf of Nektar, its Affiliates or sublicensees from the First
Commercial Sale of each such Licensed Product in a country until the later to
occur of (1) the [***] of such [***] in such country and (2) the expiration date
in such country of the last to expire of any issued [***] that includes at least
[***] (as such definition would apply if the [***] were a Licensed Patent)
covering the sale or use of such [***] in such country, and (z) Nektar shall
indemnify and hold harmless AstraZeneca and its Affiliates, Distributors and
Sublicensees from any Losses with respect to the use of the AZ Program Data or
the Exploitation of the Compound(s) or Licensed Product(s) by or on behalf of
Nektar or its Affiliates, licensees or sublicensees pursuant to Article 14 (or a
substantially equivalent provision) and any such AZ Program Data shall be
subject to the confidentiality obligations at least as restrictive as those set
forth in Article 11. If, despite such efforts, the Parties are unable
to do so within [***] from the effective date of the termination, either Party
may refer the dispute for resolution by expedited arbitration in accordance with
Section 19.3.
(a) Grant-Back
Patents. AstraZeneca automatically grants to Nektar, effective
as of the effective date of any termination of this Agreement, whether in its
entirety, or with respect to one or more countries (other than a Termination by
AstraZeneca for Material Breach), [***] under any Grant-Back Patents to Exploit
all Reversion Products (in the event of such a termination of this Agreement
with respect to one or more countries, solely with respect to the countries for
which this Agreement has been terminated). For the avoidance of
doubt, the rights granted to Nektar will be restricted solely to the Reversion
Products, and AstraZeneca does not grant by such license any rights whatsoever
to any other products or to any intellectual property rights other than to the
Grant-Back Patents as set forth above. For purposes of this Section
18.12, “Grant-Back
Patents” means any and all Patents Controlled by AstraZeneca or its
Affiliates or Sublicensees (but in the case of Patents Controlled by a
Sublicensee, solely if AstraZeneca is able, using commercially reasonable
efforts and without any payment unless such payment is paid by Nektar, to obtain
Control of such Patents from such Sublicensee) covering inventions and
technology necessary to Exploit the Existing Reversion Products that are in [***] or
that are being [***] as of the effective date of any termination of this
Agreement with respect to such countries or, in the case of termination of this
Agreements in its entirety, with respect to all countries in the Territory, and
that, as of such termination, [***].
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(b) AZ Program
Data. In the event of termination of this Agreement, whether
in its entirety, with respect to one or more countries, other than Termination
by AstraZeneca for Material Breach, AstraZeneca shall transfer and provide to
Nektar, promptly after such termination, with copies of any and all AZ Program
Data (in the case of a termination of this Agreement with respect to one or more
countries, solely to the extent relevant to the Terminated
Countries). Following such termination, Nektar shall have the rights
to use such AZ Program Data at Nektar’s discretion on a non-exclusive basis, but
only to the extent [***] to enable Nektar (or its Affiliate or licensee with
respect to the Licensed Products) to continue development and commercialization
and other Exploitation of Licensed Products (in the event of termination of this
Agreement with respect to one or more countries, solely with respect to
Terminated Countries), including use in development and regulatory filings and
in marketing and selling Licensed Products. Nektar may transfer or
license such use rights to its Affiliates and licensees with respect to the
Reversion Products.
(c) Regulatory
Documentation. In the event of termination of this Agreement,
whether in its entirety, or with respect to one or more countries, other than
Termination by AstraZeneca for Material Breach, AstraZeneca shall, to the extent
permitted under Applicable Law (and except to the extent any such Regulatory
Documentation is required by AstraZeneca with respect to one or more countries
where AstraZeneca’s rights have not been terminated), promptly transfer and
assign to Nektar any and all right, title, and interest in any and all Health
Registration Approvals obtained for Existing Reversion Products in the Terminated
Countries and all applications therefor and all other Regulatory Documentation
specifically related to such Existing Reversion Products in such
Terminated Countries (or, in the event of termination of this Agreement in its
entirety, all Health Registration Approvals and all Regulatory Documentation
obtained or submitted by AstraZeneca or any of its Affiliates for Existing
Reversion Products and all other Regulatory Documentation originally assigned by
Nektar to AstraZeneca under Section 4.9 or other provisions of this
Agreement). With respect to such transferred Health Registration
Approvals and Regulatory Documentation, AstraZeneca will submit to the
applicable Health Authorities, within [***] days after the effective date of
such termination, a letter (with a copy to Nektar) notifying such Health
Authorities of such transfer. In the event of termination of this
Agreement with respect to one or more countries (but not in its entirety),
AstraZeneca shall retain a right of reference under all such Health Registration
Approvals and other Regulatory Documentation as necessary or reasonably useful
for AstraZeneca to Exploit Licensed Products in the country or countries in
respect of which the Agreement has not been terminated (and to exercise its
retained rights and licenses under Section 18.6(b)(i)).
(d) Contracts. In
the event of termination of this Agreement, whether in its entirety, or with
respect to one or more countries, other than Termination by AstraZeneca for
Material Breach, AstraZeneca shall assign (or cause its Affiliates to assign) to
Nektar, if requested by Nektar, and Nektar will have the right, but not the
obligation, to assume, all agreements with Third Parties with respect to the
Exploitation of Existing Reversion Products, including the conduct of clinical
trials for any Existing Reversion Product, including agreements with contract
research organizations, clinical sites and investigators, that relate to
clinical trials in support of Health Registration Approvals, manufacturing
agreements, distribution agreements, and the like, for the country or countries
(or, if applicable, the Territory) with respect to which this Agreement is
terminated, unless such agreement (i) prohibits such assignment, (ii) covers
activities other than those relating to the Existing Reversion Products or (iii)
covers development or other activities relating to the Existing Reversion
Products intended for sale or distribution in one or more Non-Terminated
Countries (in which cases, (i)–(iii), if requested by Nektar, AstraZeneca shall
cooperate with Nektar in all reasonable respects to facilitate the execution of
a new agreement between Nektar and the applicable Third Party).
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18.13. No Other
Obligations. In the event of termination of this Agreement for
any reason, AstraZeneca shall not be obligated to provide Nektar with any
intellectual property or other rights or services other than that which is
explicitly provided for under this Article 18.
18.14. Unauthorized
Sales. If this Agreement has not been terminated in its
entirety, if either Party has the right to Exploit Licensed Products in one or
more countries, to the extent permitted by Applicable Law, such
Party: (a) shall, and shall cause its Affiliates, distributors and
(sub)licensees to, distribute, market, promote, offer for sale, and sell
Licensed Products only in such countries, and (b) shall not, and shall not
permit its Affiliates, distributors and (sub)licensees to, distribute, market,
promote, offer for sale or sell Licensed Products directly or indirectly (other
than pursuant to the rights granted pursuant to Section 18.6(b)(i)) (i) to any
Person outside such countries or (ii) to any Person inside such countries if
such Party is aware that such Person (A) is reasonably likely to directly or
indirectly distribute, market, promote, offer for sale or sell Licensed Products
outside such countries (and into one or more countries with respect to which the
other Party has the right to commercialize the Licensed Products) or assist
another Person to do so, or (B) has a demonstrated pattern of directly or
indirectly distributing, marketing, promoting, offering for sale or selling
Licensed Products outside such countries (and into one or more
countries with respect to which the other Party has the right to commercialize
the Licensed Products) or assisting one or more other Third Parties to do
so.
18.15. Remedies. Termination
or expiration of this Agreement by a Party shall in no way affect or limit such
Party’s right to claim against the other Party for any damages arising out of a
breach of this Agreement.
18.16. Accrued Rights; Surviving
Obligations.
(a) Accrued Rights; Survival
Following Termination. The expiration or termination of this
Agreement shall not relieve the Parties from performing any obligations accrued
under this Agreement prior to, or exercising any of its rights hereunder with
respect to any breach by the other Party of the Agreement occurring prior to,
the date this Agreement expires or terminates (including the obligation to make
payments accrued as of the effective date of such expiration or termination but
not yet paid). Each Party’s rights and obligations under Sections
6.10(c), 6.10(d), 7.14, 7.15, 7.16, 7.17, 7.18, 7.19, 10.4 (solely with respect
to Licensed Products sold by or on behalf of AstraZeneca, its Affiliates and
Sublicensees), 13.3, 18.6, 18.8, 18.9, 18.11 through 18.13, 18.15, 18.18, 20.1,
21.1, and this Section 18.16 and Articles 9 (excluding Section 9.3), 11
(excluding Section 11.1, and survival solely for the period set forth in Section
11.2), 14 (excluding Section 14.6), 15 (solely with respect to the Joint
Patents), 19, 20, and 22 shall survive the termination of this Agreement in its
entirety. In the event of a termination of this Agreement with
respect to one or more Terminated Countries, but not in its entirety, following
such termination (a) the foregoing provisions of this Agreement shall remain in
effect with respect to the Terminated Countries, and (b) the other provisions of
this Agreement shall remain in effect with respect to the Terminated Countries
solely to the extent set forth in this Article 18.
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(b) Survival Following
Expiration. If this Agreement expires, pursuant to Section
18.2(a), all of each Party’s obligations shall terminate. Each
Party’s rights and obligations under Sections 7.14, 7.15, 7.16, 7.17, 7.18,
7.19, 13.3, 18.15, 18.18, 21.1, and this Section 18.16 and Articles 4 (but
subject to Section 4.7), 9 (excluding Section 9.3), 10 (but in the case of
Section 10.2 and 10.4, solely with respect to Licensed Products sold by or on
behalf of AstraZeneca, its Affiliates and Sublicensees), 11 (excluding Section
11.1, and survival solely for the period set forth in Section 11.2), 12 (solely
with respect to Licensed Products sold by or on behalf of AstraZeneca, its
Affiliates and Sublicensees), 14 (excluding Section 14.6), 15 (solely with
respect to the Joint Patents), 19, 20, and 22 shall survive the expiration of
this Agreement.
(c) Work-in-Progress. Upon
termination of this Agreement, whether in its entirety, with respect to one or
more countries AstraZeneca, its Affiliates and Sublicensees shall be entitled to
finish any work-in-progress and to sell in the Terminated Countries any
inventory of Licensed Products that remain on hand as of the effective date of
such termination, provided that
AstraZeneca pays Nektar the royalties applicable to said subsequent sales in
accordance with the terms and conditions set forth in this
Agreement.
(d) Sublicenses. In
the case of a Termination by Nektar for Material Breach or a termination by
Nektar pursuant to Section 18.17, all sublicenses granted by AstraZeneca to
Sublicensees shall survive termination of this Agreement (provided that such
Sublicensee is in good standing under its sublicense agreement as of the
effective date of such termination and the [***], and Nektar shall assume all
such sublicense agreements as the licensor thereunder in accordance with the
terms of such sublicense agreement, provided that Nektar
shall not be required to assume any obligations in such sublicense agreement
that are greater in scope than those set forth in this Agreement, unless Nektar
otherwise agrees in writing. In all other cases, all sublicenses
granted by AstraZeneca to Sublicensees shall terminate upon termination of this
Agreement, unless Nektar otherwise agrees in writing.
18.17. Termination Upon
Bankruptcy. A Party shall be deemed a “Debtor” under this Agreement
if, at time during the Term (a) a case is commenced by or against such Party
under the Bankruptcy Code, (b) such Party files for or is subject to the
institution of bankruptcy, liquidation or receivership proceedings (other than a
case under the Bankruptcy Code), (c) such Party assigns all or a
substantially all of its assets for the benefit of creditors, (d) a receiver or
custodian is appointed for such Party’s business, or (e) substantially all of
such Party’s business is subject to attachment or similar process; provided, however, that in the
case of any involuntary case under the Bankruptcy Code, such Party shall not be
deemed a Debtor if the case is dismissed within [***] after the commencement
thereof. In the event that such Party is deemed a Debtor, the other
Party may terminate this Agreement by providing written notice to the
Debtor.
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18.18. Bankruptcy. The
Parties agree that all rights, powers and remedies of a Party provided herein
are in addition to and not in substitution for any and all other rights, powers
and remedies now or hereafter existing at law or in equity (including the
Bankruptcy Code) in the event of the commencement of a case under the Bankruptcy
Code.
(a) Rights in
Bankruptcy. All rights and licenses granted under or pursuant
to this Agreement by Nektar, or by AstraZeneca, including under Articles 4 and
18, are, and shall otherwise be deemed to be, for purposes of Section 365(n) of
the U.S. Bankruptcy Code or analogous provisions of Applicable Law outside the
United States, licenses of right to “intellectual property” as defined under
Section 101 of the U.S. Bankruptcy Code or analogous provisions of Applicable
Law outside the United States (“IP”). The Parties
agree that a Party, as licensee of such rights under this Agreement, shall
retain and may fully exercise all of its rights and elections under the U.S.
Bankruptcy Code or any other provisions of Applicable Law outside the United
States that provide similar protection for IP. The other Party (in
any capacity, including debtor-in-possession) and its successors and assigns
(including any trustee) hereby grants to such Party and its Affiliates a right
to obtain possession of and to benefit from a complete duplicate of (or complete
access to, as appropriate) any IP and all Embodiments of Intellectual Property
held by the other Party or such successors and assigns, or otherwise available
to them, which, if not already in such Party’s possession, shall be promptly
delivered to such Party upon written request therefor. The term
Embodiments of Intellectual Property includes all tangible, electronic or other
embodiments of rights and licenses hereunder, including all Licensed Products,
all Regulatory Documentation and rights of reference therein, and all
Information related to Licensed Products, Compounds, Licensed Patents, Licensed
Know-How, or Intellectual Property Rights. The other Party (in any
capacity, including debtor-in-possession) and its successors and assigns
(including any trustee) shall not interfere with the exercise by such Party or
its Affiliates of rights and licenses to IP and Embodiments of Intellectual
Property Licensed hereunder in accordance with this Agreement and agrees to
assist such Party and its Affiliates to obtain the IP and Embodiments of
Intellectual Property in the possession or control of Third Parties as
reasonably necessary or desirable for such Party or its Affiliates to exercise
such rights and licenses in accordance with this Agreement. Whenever
the other Party (in any capacity, including debtor-in-possession) and its
successors and assigns (including any trustee) provides to such Party, pursuant
to this Section 18.18(a), any of the IP or any Embodiments of Intellectual
Property Licensed hereunder in accordance with this Agreement, such Party shall
have the right to perform the obligations of the other Party hereunder with
respect to such IP and Embodiments of Intellectual Property, but neither such
provision nor such performance by such Party shall release the other Party (in
any capacity, including debtor-in-possession) and its successors and assigns
(including any trustee) from liability resulting from any rejection of the
license or the failure to perform such obligations.
(b) Treatment of Milestone
Payments. The Parties hereto acknowledge and agree that
payments made under Section 7.1 do not constitute royalties within the meaning
of U.S. Bankruptcy Code §365(n) or relate to licenses of intellectual property
hereunder.
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(c) Additional
Rights. The Parties agree that they intend the following
rights to extend to the maximum extent permitted by law, and to be enforceable
under Bankruptcy Code Section 365(n): (i) the right of access to any
IP and Embodiments of Intellectual Property of Nektar, or any Third Party with
whom Nektar contracts to perform an obligation of Nektar under this Agreement,
and, in the case of the Third Party, which is necessary for the development,
Manufacture, commercialization and use of Licensed Products or Compounds; and
(ii) the right to contract directly with any Third Party to complete the
contracted work.
19.
Dispute Resolution
19.1. Executive
Escalation. If a dispute, other than a dispute that is subject
to Article 3, arises between the Parties in connection with or relating to this
Agreement or any document or instrument delivered in connection herewith (a
“Dispute”), then either
Party shall have the right to refer such dispute to the Executives who shall
confer within [***] after such dispute was first referred to them to attempt to
resolve the Dispute by good faith negotiations. Any final decision
mutually agreed to by the Executives in writing shall be conclusive and binding
on the Parties. Except for matters for which this Agreement assigns
decision-making to the Parties or a Committee or requires the consent of one or
both of the Parties, if such Executives are not able to agree on the resolution
of an issue within [***] days after such issue was first referred to them,
either Party may, by written notice to the other Party, initiate arbitration for
resolution of such Dispute pursuant to Section 19.2, provided that such
matter is a Legal Matter. Notwithstanding the foregoing, disputes
arising on issues within the jurisdiction of the Committees shall be resolved in
accordance with the procedures set forth in Article 3.
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19.2. Arbitration,
Generally. Any Dispute which is a Legal Matter and which is
not expressly designated under this Agreement to be submitted to arbitration
pursuant to Section 19.3 or 19.4 shall be resolved by binding arbitration before
the American Arbitration Association (AAA) pursuant to AAA’s Commercial
Arbitration Rules (or the AAA International Arbitration Rules, if recommended
under the AAA guidelines), as such rules may be modified by this Article 19 or
by agreement of the Parties. The arbitration shall be conducted
before a panel of [***] arbitrators (the “Panel”). The
Parties shall each select a single independent, conflict-free arbitrator not
affiliated with either Party, who has appropriate experience in the biotech and
pharmaceutical industry involving pharmaceutical products and with dispute
resolution to resolve the matter in dispute, which individual shall not be or
have been at any time an Affiliate, employee, consultant, officer or director of
either Party or any of their respective Affiliates. Each of the
Party-selected arbitrators shall select a third arbitrator who shall meet the
criteria set forth in the immediately preceding sentence. If a Party
fails to designate a Party-selected arbitrator within [***] after submission to
arbitration or the Party-selected arbitrators are unable to reach agreement on
the selection of the third arbitrator within [***] after selection of the
Party-selected arbitrators, then either or both Parties may [***] request the
AAA to select such arbitrator (or arbitrators, as applicable) with the requisite
independence, experience and expertise. The place of arbitration
shall be, (a) San Francisco, California, if arbitration is initiated by
AstraZeneca and (b) Wilmington, Delaware, if arbitration is initiated by
Nektar. All proceedings and communications shall be in
English. The Parties agree that discovery appropriate to the issues
in the Dispute shall be permitted in the arbitration, including reasonable
document requests, pre-hearing exchanges of information, expert witness
disclosures, limited depositions of important witnesses and other appropriate
discovery, provided that such
discovery shall be limited to the narrower of (x) the scope of discovery agreed
to by the Parties, or if none can be agreed, established by the Panel, and (y)
such discovery as would be permitted by the Federal Rules of Civil Procedure
Interpretation. The arbitration shall be governed by the procedural
and substantive law set forth in Article 20. The arbitration shall be
governed by the United States Arbitration Act, 9 U.S.C. §§1-16 to the exclusion
of any inconsistent state laws. Either Party may apply to the Panel
for interim injunctive relief or may seek from any court having jurisdiction any
injunctive or provisional relief necessary to protect the rights or property of
that Party pending resolution of the matter pursuant to this Article
19. The Parties shall have the right to be represented by
counsel. Any judgment or award rendered by the Panel shall be final
and binding on the Parties, and shall be governed by the terms and conditions
hereof, including the limitation on damages set forth in Section
14.5. The Parties agree that such a judgment or award may be enforced
in any court of competent jurisdiction. The statute of limitations of
the State of New York applicable to the commencement of a lawsuit shall apply to
the commencement of arbitration under this Article 19. Each Party
shall bear its own costs and expenses and attorneys’ fees in the arbitration,
except that in the event that the Party initiating arbitration hereunder is not
the prevailing Party in the arbitration proceeding, then the Panel may order
such Party to bear all or an appropriate part (reflective of the relative
success on the issues) of the costs and expenses and reasonable attorneys’ fees
incurred by the prevailing Party based on the relative merits of each Party’s
positions on the issues in the Dispute. The Party that does not
prevail in the arbitration proceeding shall pay the arbitrator’s fees and
expenses and any administrative fees of arbitration. All proceedings
and decisions of the arbitrator(s) shall be deemed Confidential Information of
each of the Parties, and shall be subject to Article 11.
19.3. Expedited
Arbitration. For any Dispute under this Agreement that is
expressly designated under this Agreement to be submitted for arbitration
pursuant to this Section 19.3, the provisions of Section 19.2 shall apply,
except as follows: Each Party shall prepare and submit a written
summary of such Party’s position and any relevant evidence in support thereof to
the Panel and to the other Party within [***] of the selection of the
Panel. Within [***] of the delivery of such summaries by the Parties,
each Party shall submit a written rebuttal to the other Party’s
summary. At a hearing lasting no more than [***] and to commence no
later than [***] after delivery of the written rebuttals, each Party shall have
an opportunity to submit evidence and argue for its position before the Panel,
subject to reasonable time limitations to be determined by the
Panel. The Panel shall issue a reasoned award with respect to the
matter in dispute within [***] following conclusion of the hearing.
19.4. Baseball
Arbitration. For any dispute under this Agreement that is
expressly designated under this Agreement to be submitted for arbitration
pursuant to this Section 19.4, the provisions of Section 19.2 shall apply,
except as follows:
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(a) The
Party invoking baseball-style arbitration under this Section 19.4 shall so
notify the other Party in writing. The notice shall contain a list of
all issues (of those that are expressly designated under this Agreement to be
submitted to arbitration pursuant to this Section 19.4) the Party proposes to
submit to arbitration. Within [***] after receipt of any such notice,
the Party receiving the notice shall promptly notify the initiating Party of any
additional issues within the scope of issues that may be submitted to
arbitration pursuant to this Section 19.4 that the receiving Party intends to
include in the arbitration. The issues listed in the notice and in
such reply will be the only issues submitted to such arbitration.
(b) In
the case of a dispute with respect to the [***], the arbitrators on the Panel
shall each have sufficient experience with respect to the commercial manufacture
and supply of pharmaceutical products (including in agreements covering such
manufacturing relationships) to resolve the applicable dispute.
(c) If
a Party does not designate such a Party-selected arbitrator (or with respect to
disputes other than with respect to the [***], an arbitrator as described in
19.2) within [***] after submission to arbitration or if the Party-selected
arbitrators are not able to agree on a third arbitrator within [***] after
selection of the Party-selected arbitrators, then either or both Parties may
[***] request the AAA to select such arbitrator(s).
(d) Within
[***] after the designation of the Panel, the Parties shall each simultaneously
submit to the arbitrator(s) and one another in writing a proposal that contains
that Party’s “final best offer” as to the matter that is the subject of the
Dispute. In the case of disputes with respect to the [***], the
Parties shall submit a proposed form [***] and written summary of the issues on
which the Parties disagree and the negotiating history with respect
thereto. If a Party fails to submit a proposal within such timeframe,
then the proposal of the submitting Party shall prevail. Each Party
shall have [***] from receipt of the other Party’s submission to submit a
written response to such summary and at a hearing to take place on no more than
[***] and to commence no later than [***] after submission of the written,
responses, each Party shall have a reasonable period of time to be determined by
the Panel (which period of time shall be sufficient for the Panel to fully
understand the proposals and the relative merits thereof) to argue for its
proposal before the Panel. To the extent permitted by the AAA’s
Commercial Arbitration Rules the arbitrator(s) shall have the right to meet with
the Parties, either alone or together, as necessary to make a
determination.
(e) The
Panel shall, within [***] after the submission of the responses, or such longer
period as the Parties may agree, select the single proposal that, in the
determination of the Panel, as a whole is the most consistent with the
requirements of this Agreement and is the most fair and reasonable to the
Parties in light of the totality of the circumstances and the terms of this
Agreement. At any time prior to the determination, either Party may
accept the other Party’s position on any unresolved issue. The
Parties shall inform the Panel of such accepted position and in such event such
position will be deemed part of the final agreement and no longer subject to
arbitration.
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(f) In
the case of disputes with respect to the [***], the arbitrator’s decision shall
take into account customary and commercially reasonable industry practices for
suppliers and purchasers of similar products. The selected form [***]
shall be deemed to be immediately effective and shall be promptly executed by
the Parties. Such [***] shall include, and the arbitrator shall not
have the authority to change (unless otherwise expressly agreed in writing by
the Parties), the prices and the terms as set forth in 8.2(c).
20.
Governing Law, Jurisdiction, Venue and Service
20.1. Governing
Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of New York, excluding any conflicts or
choice of law rule or principle that might otherwise refer construction or
interpretation of this Agreement to the substantive law of another
jurisdiction. The Parties agree to exclude the application to this
Agreement of the United Nations Convention on Contracts for the International
Sale of Goods.
20.2. Jurisdiction. Subject
to Section 22.9 and Article 19, the Parties hereby irrevocably and
unconditionally consent to the exclusive jurisdiction of the courts located in
the Southern District of New York for any action, suit or proceeding (other than
appeals therefrom) arising out of or relating to this Agreement, and agree not
to commence any action, suit or proceeding (other than appeals therefrom)
related thereto except in such courts. The Parties irrevocably and
unconditionally waive their right to a jury trial.
20.3. Venue. The
Parties further hereby irrevocably and unconditionally waive any objection to
the laying of venue of any action, suit or proceeding (other than appeals
therefrom) arising out of or relating to this Agreement in the courts of New
York, and hereby further irrevocably and unconditionally waive and agree not to
plead or claim in any such court that any such action, suit or proceeding
brought in any such court has been brought in an inconvenient
forum.
20.4. Service. Each
Party further agrees that service of any process, summons, notice or document by
registered mail to its address set forth in Section 22.3 shall be effective
service of process for any action, suit or proceeding brought against it under
this Agreement in any such court.
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21.
Assignment and Change of Control
21.1. Assignment. Neither
Party may assign its rights or delegate its obligations under this Agreement, in
whole or in part, without the prior written consent of the other Party, such
consent not to be unreasonably withheld, except that a Party shall always have
the right, without such consent, (a) to assign any or all of its rights and
delegate any or all of its obligations hereunder to any of its Affiliates, provided, however, that such
assigning Party shall remain responsible for full performance of such assigned
obligations, or (b) to its successor in interest (whether by merger,
acquisition, asset purchase, or otherwise) to, in the case of Nektar as the
assigning Party, all or substantially all of the business of Nektar and its
Affiliates, and in the case of AstraZeneca as the assigning Party, all or
substantially all of the business of AstraZeneca and its Affiliates to which
this Agreement relates; provided that such
assigning Party shall provide written notice to the other Party within [***]
after such assignment or delegation to any Third Party, and the assignee shall
undertake in writing to the other Party to perform all obligations of assigning
Party under this Agreement. Notwithstanding the forgoing, in the case
of Nektar as the assigning Party, (i) until the [***], any permitted successor
of Nektar shall have [***] and (ii) any permitted successor of Nektar in a
transaction closing before the date [***] after the Effective Date shall have
(or shall preserve at Nektar) [***] as of the Effective Date. Any
permitted successor of a Party or any permitted assignee of all of a Party’s
rights under this Agreement that has also assumed all of such Party’s
obligations hereunder in writing shall, upon any such succession or assignment
and assumption, be deemed to be a party to this Agreement as though named herein
in substitution for the assigning Party, whereupon the assigning Party shall
cease to be a party to this Agreement and shall cease to have any rights or
obligations under this Agreement. All validly assigned rights of a
Party shall inure to the benefit of and be enforceable by, and all validly
delegated obligations of such Party shall be binding on and be enforceable
against, the permitted successors and assigns of such Party. Any
attempted assignment or delegation in violation of this Section 21.1 shall be
void. Notwithstanding any other provision of this Section 21.1, the
terms of this Agreement may be varied, amended or modified or this Agreement may
be suspended, canceled or terminated without the consent of any assignee or
delegate that is not deemed pursuant to the provisions of this Section 21.1 to
have become a party to this Agreement.
21.2. Subcontracting. Notwithstanding
Section 21.1, AstraZeneca shall have the right (i) to perform any or all of its
obligations and exercise any or all of its rights hereunder pursuant to Section
4.2, 4.3 or 4.4, (ii) to perform any or all of its obligations and exercise any
or all of its rights under this Agreement through any of its Affiliates; and
(iii) to subcontract its obligations hereunder to a Third Party, provided that
AstraZeneca remains liable for such Third Party’s performance of such
obligations.
21.3. Nektar Change of
Control. Upon any Change of Corporate Control where Nektar is
acquired by (a) [***] or (b) a Third Party that is [***] researching with the
intent to [***] (or directly assisting another Person to commercialize) a [***]
(and such Third Party does not cease permanently all such activities within
[***] of such acquisition), then (i) all of Nektar’s rights to receive reports
and information under this Agreement (including reports and information required
to be delivered pursuant to Section 6.8) shall terminate, except with respect to
royalty reports under Section 7.12 and audit rights under Section 7.14(b) and
(ii) all Committees and the Patent Working Group shall be terminated, and
notwithstanding Article 3, AstraZeneca shall have the sole right to make all
decisions previously in the jurisdiction of any Committee, including decisions
relating to the development and commercialization of Licensed Products without
consultation with Nektar. Decision-making with respect to matters
previously in the jurisdiction of the Patent Working Group shall continue [***],
but without any obligation to coordinate or keep the other Party informed
through the Patent Working Group. Nektar shall provide AstraZeneca
with [***] prior written notice of such Change of Corporate
Control.
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21.4. Obligations of Acquiror of a
Party. Notwithstanding anything in this Agreement to the
contrary, if a Party (the “Subject Party”) merges or
consolidates with, or acquires or is acquired by, a Third Party that is [***] in
any country (but not including, for clarity, an [***] limited to Intellectual
Property Rights), (a) the Patents or Intellectual Property Rights owned or
otherwise Controlled, as of the effective date of the transaction, by any
counterparty with respect to the transaction (the “Counterparty”) (or the
Counterparty’s Affiliate, which Affiliate is not an Affiliate of the Subject
Party immediately prior to the closing of such transaction(s) (“Counterparty Affiliate”))
shall not become subject to the license grants, assignments, reports,
disclosures and other requirements of this Agreement, and (b) the Counterparty
and the Counterparty Affiliates shall not become subject to the covenants in
Section 4.5(c) (but, for clarity, the Subject Party and its Affiliates (other
than the Counterparty and any Counterparty Affiliate), and its and their
successors, shall remain subject to such covenants); provided, in each
case, ((a) and (b)), that neither the Counterparty nor any Counterparty
Affiliate (i) receives or otherwise has access to the Confidential Information
of the Subject Party (and, if Nektar is the Subject Party, the Restricted
Information) or (ii) practices the licenses or rights, directly or indirectly,
granted to the Subject Party by the other Party hereto (whether by the grant of
a sublicense or otherwise). If any such Counterparty or Counterparty
Affiliate receives or gains access to such information, or practices such
licenses or rights, directly or indirectly, then (x) the Patents or Intellectual
Property Rights of such Counterparty or Counterparty Affiliate shall become
automatically subject to the license grants, assignments, reports, disclosures,
and other requirements of this Agreement, and (y) the Counterparty and the
Counterparty Affiliates shall become subject to the covenants in Section
4.5(c). For clarity, this Section 21.4 shall apply solely in the case
in which the Subject Party maintains a separate corporate existence from the
Counterparty and the Counterparty Affiliates.
21.5. [***].
Notwithstanding Section 4.5(c), if [***], or [***], that is researching,
developing, or commercializing a [***] in any country(ies), or acquires assets
that include the business of researching, developing, or commercializing a [***]
in any country(ies), then the continuing research, development, or
commercialization of such Competing Product in such country(ies) by the Party or
its Affiliates following such transaction shall not constitute a breach of
Section 4.5(c) (without limitation of any other exception from the application
of Section 4.5(c) set forth in Section 21.4) during the applicable period in
which Section 4.5(c) is applicable (the “Prohibition Period”), provided that the
affected Party within [***] after the date of such transaction notifies the
other Party that it intends to:
(a) refrain
from, and cause any relevant Affiliate to refrain from, [***] in such
country(ies) within [***] in compliance with Applicable Law during the
Prohibition Period;
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(b) [***]
or cause its relevant Affiliate to [***] in the applicable country(ies) within
[***] (or for such longer period as the Party is actively engaged in [***] to
divest such [***]), it being agreed by the Parties that: (i) the
[***] Party shall be entitled to receive fees, milestones and royalties on sales
of any [***] through license, to Manufacture such [***] for the acquiror or
licensee of the Competing Product, and to provide technology transfer,
transition services and other support in connection with the sale or license;
and (ii) the [***] Party shall have the right to take back rights to the [***]
in the applicable country(ies) (A) at any time following the Prohibition Period,
or (B) at any other time in the event of a breach of any license granted by such
Party as its means of [***] its interest in such [***] by the licensee, in which
event under clause (B) the [***] Party shall be required again to [***] such
program or, if applicable, terminate this Agreement pursuant to this Section
21.5).
If the
Party undergoing such transaction fails to provide such notice within such [***]
period or fails to carry out the designated actions within the time periods set
out above or such longer period as the Parties may otherwise agree in writing,
then, as applicable, such Party shall be deemed to be in breach of Section
4.5(c) to the extent would be the case without application of this Section 21.5,
and as of the day such transaction was consummated.
22.
Miscellaneous
22.1. Force
Majeure.
(a) In
this Agreement, “Force
Majeure” means an event which is beyond a non-performing Party’s
reasonable control, including an act of God, act of the other Party, strike,
lock-out or other industrial/labor disputes (whether involving the workforce of
the Party so prevented or of any other Person), war, riot, civil commotion,
terrorist act, malicious damage, epidemic, quarantine, fire, flood, storm,
natural disaster or compliance with any law or governmental order, rule,
regulation or direction (including changes in the requirements of the Health
Authorities), whether or not it is later held to be invalid.
(b) The
Force Majeure Party shall, within thirty (30) days of the occurrence of a Force
Majeure event, give notice in writing to the other Party specifying the nature
and extent of the event of Force Majeure, its anticipated duration and any
action being taken to avoid or minimize its effect. Subject to
providing such notice and to Section 22.1(a), the Force Majeure Party shall
not be liable for delay in performance or for non-performance of its obligations
under this Agreement, in whole or in part, nor shall the other Party have the
right to terminate this Agreement, except as otherwise provided in this
Agreement, where non-performance or delay in performance has resulted from an
event of Force Majeure. The suspension of performance allowed
hereunder shall be of no greater scope and no longer duration than is reasonably
required.
(c) The
Force Majeure Party shall use reasonable endeavors, without being obligated to
incur any expenditure or cost, to (i) bring the Force Majeure event to a close
or (ii) find a solution by which the Agreement may be performed despite the
continuation of the event of Force Majeure.
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22.2. Severability. To the
fullest extent permitted by Applicable Law, the Parties waive any provision of
law that would render any provision in this Agreement invalid, illegal or
unenforceable in any respect. If any provision of this Agreement is
held to be invalid, illegal or unenforceable, in any respect, then such
provision will be given no effect by the Parties and shall not form part of this
Agreement. To the fullest extent permitted by Applicable Law and if
the rights or obligations of any Party will not be materially and adversely
affected, all other provisions of this Agreement shall remain in full force and
effect, and the Parties shall use their best efforts to negotiate a provision in
replacement of the provision held invalid, illegal or unenforceable that is
consistent with Applicable Law and achieves, as nearly as possible, the original
intention of the Parties.
22.3. Notices.
(a) Notice
Requirements. Any notice, request, demand, waiver, consent,
approval or other communication permitted or required under this Agreement shall
be in writing, shall refer specifically to this Agreement and shall be deemed
given only if delivered by hand or sent by facsimile transmission (with
transmission confirmed) or by internationally recognized overnight delivery
service that maintains records of delivery, addressed to the Parties at their
respective addresses specified in Section 22.3(b) or to such other address as
the Party to whom notice is to be given may have provided to the other Party in
accordance with this Section 22.3. Such notice shall be deemed to
have been given as of the date delivered by hand or transmitted by facsimile
(with transmission confirmed) or on the second
business day (at the place of delivery) after deposit with an internationally
recognized overnight delivery service. Any notice delivered by
facsimile shall be confirmed by a hard copy delivered as soon as practicable
thereafter. This Section 22.3 is not intended to govern the
day-to-day business communications necessary between the Parties in performing
their obligations under the terms of this Agreement.
(b) Address for
Notice.
[***]
22.4. Relationship of the
Parties. The status of a Party under this Agreement shall be that of an
independent contractor. Nothing contained in this Agreement shall be
construed as creating a partnership, joint venture or agency relationship
between the Parties or, except as otherwise expressly provided in this
Agreement, as granting either Party the authority to bind or contract any
obligation in the name of or on the account of the other Party or to make any
statements, representations, warranties or commitments on behalf of the other
Party. All persons employed by a Party shall be employees of such
Party and not of the other Party and all costs and obligations incurred by
reason of any such employment shall be for the account and expense of such
Party.
22.5. Entire Agreement.
This Agreement constitutes the entire agreement between the Parties with respect
to the subject matter of the Agreement. This Agreement supersedes all
prior agreements, whether written or oral, with respect to the subject matter of
the Agreement. Nektar shall, and AstraZeneca shall cause its
applicable Affiliate to, terminate the Confidentiality Agreement effective as of
the Effective Date and to agree that any surviving obligations thereunder are
superseded by this Agreement. Each Party
confirms that it is not relying on any statements, representations, warranties
or covenants of any person (whether a Party to this Agreement or not) except as
specifically set out in this Agreement. Nothing in this Agreement is
intended to limit or exclude any liability for fraud. All Schedules
and Exhibits referred to in this Agreement are intended to be and are hereby
specifically incorporated into and made a part of this Agreement. In
the event of any inconsistency between any such Schedules or Exhibits and this
Agreement, the terms of this Agreement shall govern.
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22.6. English Language.
This Agreement is written and executed in the English language. Any
translation into any other language shall not be an official version of this
Agreement and in the event of any conflict in interpretation between the English
version and such translation, the English version shall prevail.
22.7. Amendment. Any
amendment or modification of this Agreement must be in writing and signed by
authorized representatives of both Parties.
22.8. Waiver and Non-Exclusion of
Remedies. A Party’s failure to enforce, at any time or for any period of
time, any provision of this Agreement, or to exercise any right or remedy shall
not constitute a waiver of that provision, right or remedy or prevent such Party
from enforcing any or all provisions of this Agreement and exercising any rights
or remedies. To be effective any waiver must be in
writing. The rights and remedies provided herein are cumulative and,
except as expressly provided in Article 18 and elsewhere in this Agreement, do
not exclude any other right or remedy provided by law or otherwise available,
except as expressly set forth herein.
22.9. Equitable Relief.
Each Party acknowledges and agrees that the restrictions set forth in Section
4.5(c) and Article 11 of this Agreement are reasonable and necessary to protect
the legitimate interests of the other Party, and that the other Party would not
have entered into this Agreement in the absence of such restrictions, and that
any breach or threatened breach of any provision of Section 4.5(c) and Article
11 will result in irreparable injury to the other Party for which may be no
adequate remedy at law. In the event of a breach or threatened breach
of any provision of Section 4.5(c) and Article 11 by a Party, the other Party
shall be authorized and entitled to seek to obtain from any court of competent
jurisdiction equitable relief, whether preliminary or permanent, specific
performance and an equitable accounting of all earnings, profits and other
benefits arising from such breach, which rights shall be cumulative and in
addition to any other rights or remedies to which such other Party may be
entitled in law or equity. Nothing in this Section 22.9 is intended,
or should be construed, to limit a Party’s rights to equitable relief or any
other remedy for a breach of any other provision of this Agreement.
22.10. Further Assurance.
Each Party shall perform all further acts and things and execute and deliver
such further documents as may be necessary or as the other Party may reasonably
require to implement or give effect to this Agreement.
22.11. Expenses. Except as
otherwise expressly provided in this Agreement, each Party shall pay the fees
and expenses of its respective lawyers and other experts and all other expenses
and costs incurred by such Party incidental to the negotiation, preparation,
execution and delivery of this Agreement.
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22.12. Counterparts. This
Agreement may be executed in any number of counterparts, each of which shall be
deemed an original and all of which taken together shall be deemed to constitute
one and the same instrument. An executed signature page of this
Agreement delivered by facsimile transmission or by electronic mail in “portable
document format” (“.pdf”) shall be as effective as an original executed
signature page.
[Signature
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EXECUTION VERSION
THIS
AGREEMENT IS EXECUTED by the authorized representatives of the Parties as of the
date first written above.
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SIGNED
for and on behalf of
ASTRAZENECA
AB (publ)
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SIGNED
for and on behalf of
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Signature
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Signature
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Name:
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[***]
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Name:
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[***]
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Title:
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Authorised Signatory
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Title:
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[***]
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