***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

Exhibit 10.1

COLLABORATION AND LICENSE AGREEMENT

by and between

DAIICHI SANKYO EUROPE GMBH

and

NEKTAR THERAPEUTICS

DATE:  May 30, 2016

 

  

 

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

1.

Definitions and Interpretations

1

 

 

 

 

 

1.1

Definitions

1

 

1.2

Interpretation

14

 

 

 

2.

Grant of Rights

15

 

 

 

 

 

2.1

License Grants to Daiichi Sankyo

15

 

2.2

Retained Rights

15

 

2.3

Sublicenses

15

 

2.4

License Limitations

16

 

2.5

Non-compete

16

 

2.6

No Implied Licenses

17

 

2.7

Territory/Outside the Territory

17

 

 

 

3.

Governance

18

 

 

 

 

 

3.1

JSC Formation and Responsibilities

18

 

3.2

Membership

19

 

3.3

Meetings and Quorum

19

 

3.4

Decision-Making and Dispute Resolution

20

 

3.5

Limitations on Authority

20

 

 

 

4.

Development

20

 

 

 

 

 

4.1

BCBM Trial

20

 

4.2

Development by Daiichi Sankyo

21

 

4.3

Development Reporting

21

 

4.4

Records of Development Activities

21

 

4.5

New NKTR-102 Data

22

 

4.6

Post MA Approval Obligations Imposed by Health Authorities

22

 

 

 

5.

Commercialization

22

 

 

 

 

 

5.1

Allocation of Responsibilities

22

 

5.2

Primary Indication

22

 

5.3

New Indications

23

 

5.4

Commercialization Diligence

23

 

5.5

Commercialization Reporting

23

 

 

 

6.

Regulatory Matters

23

 

 

 

 

 

6.1

Nektar Responsibilities for MAAs and MAs

23

 

6.2

Daiichi Sankyo Responsibilities for MAAs and MAs

24

 

6.3

Right of Reference

25

 

6.4

Opportunity to Comment on Regulatory Submissions

25

 

6.5

Written Communications with Health Authorities

26

 

6.6

Meetings with Health Authorities

26

 

6.7

Pharmacovigilance and Quality Agreements

27

 

 

 

 

-i-

 

  

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

7.

Payments and Consideration

27

 

 

 

 

 

7.1

Initial License Fee

27

 

7.2

Milestone Payments

28

 

7.3

Royalties

29

 

7.4

Payment Terms

30

 

7.5

Records Retention; Audit

31

 

7.6

No Guarantee

32

 

 

 

8.

Manufacturing and Supply

32

 

 

 

 

 

8.1

Manufacturing Responsibility

32

 

8.2

Supply Agreement Provisions – Manufacturing

33

 

8.3

Supply Agreement Provisions – Packaging

33

 

 

 

9.

Ownership of Intellectual Property

34

 

 

 

 

 

9.1

Disclosure

34

 

9.2

Ownership of Inventions

34

 

9.3

Assignments

35

 

9.4

Trademarks

35

 

 

 

10.

Confidentiality and Non-Disclosure

36

 

 

 

 

 

10.1

Confidentiality Generally

36

 

10.2

Permitted Disclosures

36

 

10.3

Exclusions

37

 

10.4

Confidentiality of Terms of Agreement

37

 

10.5

Use of Name

38

 

10.6

Press Release

38

 

10.7

Publication

39

 

 

 

11.

Representations, Warranties and Covenants

40

 

 

 

 

 

11.1

Mutual Representations and Warranties

40

 

11.2

Representations and Warranties of Nektar

40

 

11.3

Compliance with Laws

42

 

11.4

DISCLAIMER OF WARRANTY

44

 

 

 

12.

Indemnity

44

 

 

 

 

 

12.1

Indemnification by Daiichi Sankyo

44

 

12.2

Indemnification by Nektar

45

 

12.3

Indemnification Procedures

45

 

12.4

LIMITATION OF LIABILITY

46

 

12.5

Insurance

46

 

 

 

13.

Maintenance and Prosecution of Licensed Patents

46

 

 

 

 

 

13.1

Prosecution of Licensed Patents

46

 

13.2

Patent Term Extensions

47

 

 

 

 

-ii-

 

  

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

14.

Enforcement of Patents

47

 

 

 

 

 

14.1

Notice of Infringement

47

 

14.2

Control of Enforcement

48

 

14.3

Cooperation

48

 

14.4

Recovery

48

 

 

 

15.

Potential Third Party Actions

48

 

 

 

 

 

15.1

Invalidity or Unenforceability Defenses or Actions

48

 

15.2

Third Party Litigation

48

 

15.3

Cooperation

48

 

 

 

16.

Term and Termination

49

 

 

 

 

 

16.1

Term

49

 

16.2

Termination by Either Party

49

 

16.3

Termination by Daiichi Sankyo

51

 

16.4

Termination by Nektar

51

 

16.5

Rights and Obligations Following Termination

51

 

16.6

Post-termination Indemnification

53

 

16.7

Remedies

53

 

16.8

Accrued Rights; Surviving Obligations

53

 

 

 

17.

Informal Dispute Resolution

53

 

 

 

18.

Governing Law, Jurisdiction, Venue and Service

54

 

 

 

 

 

18.1

Governing Law

54

 

18.2

Jurisdiction

54

 

18.3

Venue

54

 

18.4

[Reserved]

54

 

18.5

Change of Control

54

 

18.6

Assignment

54

 

 

 

19.

Miscellaneous

55

 

 

 

 

 

19.1

Force Majeure

55

 

19.2

Severability

55

 

19.3

Notices

56

 

19.4

Relationship of the Parties

56

 

19.5

Entire Agreement

57

 

19.6

English Language

57

 

19.7

Amendment

57

 

19.8

Waiver

57

 

19.9

Equitable Relief

57

 

19.10

Further Assurance

58

 

19.11

Expenses

58

 

19.12

Counterparts

58

 

 

 

-iii-

 

  

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

TABLE OF CONTENTS

Exhibits

 

 

 

 

 

Exhibit A

 

Licensed Product Patents

Exhibit B-1

 

Nektar Marks

Exhibit B-2

 

Nektar House Marks

Exhibit C

 

Summary of BCBM Protocol

Exhibit D

 

Trademark Quality Guidelines

 

 

 

 

-v-

 

  

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

This Collaboration and License Agreement (the “Agreement”) is made as of the 30
day of May, 2016 (the “Effective Date”), by and between

(1)

Daiichi Sankyo Europe GmbH, a company with limited liability incorporated under
German law with offices at Zielstattstr. 48, 81379 Munich, Germany (“Daiichi
Sankyo”); and

(2)

Nektar Therapeutics, a Delaware corporation with offices at 455 Mission Bay
Boulevard South, San Francisco, California, USA 94158 (“Nektar”).

Recitals

(A)

WHEREAS, Nektar is Developing and Controls Intellectual Property Rights covering
the Licensed Product;

(B)

WHEREAS, Daiichi Sankyo has experience in, among other things, the Development
and Commercialization of pharmaceutical compounds in the Territory; and

(C)

WHEREAS, Nektar desires to supply and to grant, a license to Daiichi Sankyo, and
Daiichi Sankyo desires to receive a license, to Commercialize the Licensed
Product in the Territory in accordance with the terms and conditions set forth
below.

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:

1.Definitions and Interpretations.

1.1Definitions.  Unless otherwise specifically provided herein, the following
terms, when used with a capital letter at the beginning, shall have the
following meanings:

“Actual Labeled Indication” means the labeling for the Licensed Product for the
Primary Indication in the form approved by the applicable Health Authority in
the Final Marketing Authorization for the EMA Territory.

“Actual Labeled Indication Population” means the number of patients in the EMA
Territory for the Actual Labeled Indication, as of the date of the receipt of
Final Marketing Authorization.

“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 such 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 any applicable corresponding regulations in
countries within the

1/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

Territory, as may be amended from time to time) occurring following or during
exposure to or use of a Licensed Product.

“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 (a) direct or indirect ownership of
fifty percent (50%) or more of the shares of stock entitled to vote for the
election of directors, in the case of a corporation, or fifty percent (50%) or
more of the equity interest in the case of any other type of legal entity; (b)
status as a general partner in any partnership; or (c) any other arrangement
whereby a Person has the power to direct and control the management or policies
of another Person, whether through ownership of voting securities or by contract
relating to voting rights or corporate governance, resolution, regulation or
otherwise.  In the case of entities organized under the laws of certain
countries, the maximum percentage ownership permitted by law for a foreign
investor may be less than fifty percent (50%), and in such case such lower
percentage shall be substituted in the preceding sentence, provided that such
foreign investor has the power to direct the management and policies of such
entity.

“Agreed Indication” means a particular use for a Licensed Product in the
Licensed Field that is (a) the Primary Indication, and (b) any New Indication,
approved pursuant to Section 4.2.

“Agreement” has the meaning set forth in the preamble.

“Ancillary Agreements” means, collectively, the Pharmacovigilance Agreement, the
Quality Agreement and the Supply Agreement.

“Annual Net Sales” means the aggregate Net Sales made during a given Calendar
Year.

“Anti-Corruption Laws” means the U.S. Foreign Corrupt Practices Act, as amended,
the UK Bribery Act 2010, as amended, and any other applicable anti-corruption
laws and laws for the prevention of fraud, racketeering, money laundering or
terrorism in the Territory.

“Anticipated Labeled Indication” means the labeling for the Licensed Product for
the Primary Indication in the form in which it is submitted to the EMA in the
Conditional MAA by Nektar, which is expected to be substantially similar to
either the Narrow Labeled Indication or the Broad Labeled Indication, depending
on the regulatory strategy decision made by Nektar after consultation with
Daiichi Sankyo through the JSC.

“Anticipated Labeled Indication Population” means the number of patients in the
EMA Territory for the Anticipated Labeled Indication, as of the date of
submission of the Conditional MAA by Nektar.

2/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

“Applicable Law” means individually and collectively, any 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.

“Arbitrator” has the meaning set forth in Section 7.2(b).

“Bankruptcy Code” means Title 11, United States Code, as amended, or analogous
provisions of Applicable Law outside the United States.

“BCBM” means metastatic breast cancer in adult patients with brain metastases
and/or a history of brain metastases.

“BCBM Trial Protocol” means that certain Clinical Trial Protocol entitled “A
Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 versus Treatment
of Physician’s Choice (TPC) in Patients with Metastatic Breast Cancer Who Have
Stable Brain Metastases and Have Been Previously Treated with an Anthracycline,
a Taxane, and Capecitabine,” a summary of which is set forth on Exhibit C of
this Agreement, as amended from time to time in accordance with Section 4.1.

“BCBM Trial” means that certain Phase 3 Clinical Study to be conducted by Nektar
pursuant to the BCBM Trial Protocol.

“Breaching Party” has the meaning set forth in Section 16.2(a).

“Broad Labeled Indication” means the following:  treatment of adult patients
with advanced breast cancer [***].

“Business Day” means any day other than (a) Saturday or Sunday, (b) any other
day on which national banks in New York, New York are generally permitted or
required to be closed, (c) any other day on which national banks in Munich,
Germany are generally permitted or required to be closed, or (d) the nine (9)
consecutive days beginning on December 24th and continuing through January 1st
to the extent not already covered in (a), (b) or (c).

“Calendar Quarter” means each successive period of three (3) calendar months
commencing on January 1st, April 1st, July 1st and October 1st.

“Calendar Year” means each successive period of twelve (12) calendar months
commencing on January 1st.

“Change of Control” means, with respect to a Party: (a) the sale, conveyance,
transfer or lease of all or substantially all of such Party’s assets or business
relating to this Agreement to any Third Party; (b) a merger, reorganization or
consolidation involving such Party in which the total voting power of the stock
of such Party outstanding immediately prior thereto ceases to represent at least
[***] of the combined voting power of the stock outstanding of the surviving
entity normally entitled to vote in elections of directors immediately after
such merger, reorganization or consolidation; or (c) a Person or group of
Persons acting in concert becoming

3/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

the beneficial owner, directly or indirectly, of more than [***] of the total
voting power of the stock then outstanding of such Party normally entitled to
vote in elections of directors.

“Clinical Study” means a human clinical study conducted on human subjects,
including any Phase 1 Clinical Study, Phase 2 Clinical Study or Phase 3 Clinical
Study.

“Commercialization Plan” has the meaning set forth in Section 5.2.

“Commercialize” or “Commercializing” means to market, promote, distribute, offer
for sale, sell, have sold, import, have imported, export, have exported or
otherwise commercialize a compound or product, including establishing the price,
reimbursement and formulary listing for such compound or product, but excluding
for the avoidance of doubt, Manufacturing.  When used as a noun,
“Commercialization” means any and all activities involved in Commercializing.

“Commercially Reasonable Efforts” means, with respect to the efforts to be
expended by a Party with respect to any objective under this Agreement, diligent
efforts to accomplish such objective that are consistent with the then current
usual practice of such Party in pursuing the Manufacture, Development or
Commercialization, as the case may be, of its other comparable compounds or
products, it being understood and agreed that, with respect to the Development,
Manufacture or Commercialization of the Licensed Product, as the case may be,
conducting such tasks using such efforts and resources that are typically used
by such Party and its Affiliates in conducting the same tasks on its own
comparable compounds or products, which means compounds and products with
similar commercial and scientific potential at a similar stage in their
lifecycle, taking into consideration safety and efficacy, the cost to Develop,
the competitiveness of alternative compounds and products, the cost of goods,
the nature and extent of market exclusivity (including Patent coverage and
regulatory data protection), the likelihood of Health Registration Approval,
expected profitability and all other factors that are typically taken into
consideration by such Party and its Affiliates 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).  Further, to the extent that a
Party’s obligations hereunder or a Party’s ability to exercise its rights
hereunder are adversely affected by the other Party’s failure to perform any of
its respective obligations hereunder or by the other Party’s breach of any of
its representations or warranties hereunder, such affected Party shall be
relieved of its obligations to perform any affected obligations hereunder to the
extent such obligations are impacted by the failure to perform and the impact of
such other Party’s performance failure or breach will be taken into account in
determining whether such affected Party has used its Commercially Reasonable
Efforts hereunder.

“Competing Product” means a [***] which has approved labeling for the [***],
other than the Licensed Product. [***] as used in the preceding sentence shall
not include [***].

“Competitor” means a Person engaged in the business of Commercializing [***] in
any country in the Territory.

“Complaining Party” has the meaning set forth in Section 16.2(a).

4/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

“Conditional MAA” means a conditional marketing authorization application for a
medicinal product for human use pursuant to Regulation (EC) 507/2006, falling
within the scope of Regulation (EC) 726/2004 of the European Parliament and of
the Council, each as amended from to time, or the equivalent application
required by the applicable Health Authority under the provisions of Applicable
Law in a country within the Other Territory.

“Conditional Marketing Authorization” means (a) authorization by the applicable
Health Authority of a Conditional MAA for the Licensed Product for the Primary
Indication in the EMA Territory; and (b) authorization by the applicable Health
Authority of a Conditional MAA for the Licensed Product for the Primary
Indication in a country within the Other Territory.

“Confidential Information” of a Party means, subject to Section 10.3, any and
all confidential or proprietary information of such Party or its Affiliates,
including 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, and whether or not such information is identified as confidential at
the time of disclosure if a reasonable person receiving such information would
have known it to be confidential (with the burden of proof for such showing on
the disclosing Party), which is disclosed prior to or after the Effective Date
of this Agreement by or on behalf of such Party (or any of its Affiliates or
Representatives) to the other Party (or any of its Affiliates or
Representatives).  As set forth in Section 10.4, the terms and conditions of
this Agreement shall be considered Confidential Information of both Parties.

“Confidentiality Agreements” means (a) that certain Mutual Confidential
Disclosure Agreement, dated as of April 23, 2015, by and between Nektar and
Daiichi Sankyo Europe GmbH; and (b) that certain Mutual Confidential Disclosure
Agreement, dated as of May 19, 2015, by and between Nektar and Daiichi Sankyo,
Inc.

“Control” means, with respect to any item of Information, Patent or other
Intellectual Property Right, that the applicable Party or its Affiliates owns or
has a license under such Information, Patent or other 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 other 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, or
misappropriating the proprietary or trade secret information of a Third Party.

“Cover”, “Covering” or “Covered” means that, but for a license granted to a
Person under a claim included in a Patent, the use, sale, offer for sale,
manufacturing, importation or other exploitation of such Licensed Product in the
Territory by such Person would infringe such claim.

“CTA” means a clinical trial application or other documentation required to be
filed with the applicable Health Authority for authorization to commence
Clinical Studies in the applicable jurisdiction.

“Cure Period” has the meaning set forth in Section 16.2(a).

5/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

“Daiichi Sankyo Core Technology” means technology encompassing (a) [***]; (b)
[***]; and (c) [***].

“Daiichi Sankyo Core Technology Inventions” has the meaning set forth in Section
9.2(b).

“Daiichi Sankyo Parties” has the meaning set forth in Section 12.2.

“Debtor” has the meaning set forth in Section 16.2(b).

“Develop” or “Developing” means any and all drug development activities
conducted before or after obtaining Health Registration Approval that are
reasonably related to or leading to the development, preparation and submission
of data and information to a Health Authority for the purpose of obtaining,
supporting or expanding a Health Registration Approval, including but not
limited to all activities related to pharmacokinetic profiling, design and
conduct of pre-clinical development, non-clinical development, pre-clinical
studies, in vitro studies, Clinical Studies, other studies and scientific
activities ordinarily conducted in the pharmaceutical industry in the EMA
Territory as a prerequisite to or in connection with a Clinical Study,
regulatory affairs, statistical analysis, report writing and regulatory filing
creation and submission, but excluding for the avoidance of doubt, Research and
Manufacturing.  When used as a noun, “Development” means any and all activities
involved in Developing.

“Development Plan” has the meaning set forth in Section 4.2.

“Disclosing Party” has the meaning set forth in Section 10.1.

“EC Community Code” means Directive 2001/83/EC issued by the European Parliament
and of the Council on the Community code on November 6, 2001, as amended from
time to time.

“Effective Date” has the meaning set forth in the preamble.

“EMA” means the European Medicines Agency, and any successor agency thereto.

“EMA Territory” means those countries in the Territory subject to the
jurisdiction of the EMA.

“Enforcing Party” has the meaning set forth in Section 14.3.

“European Economic Area” means those countries that are party to that certain
European Economic Area Agreement dated as of January 1, 1994, as amended from
time to time.

“Executives” means, (a) with respect to Daiichi Sankyo, Head, Affiliate and
Brand Management and (b) with respect to Nektar, the CEO of Nektar.

6/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

“Final Marketing Authorization” means Health Registration Approval by the
applicable Health Authority for the Licensed Product for the Primary Indication
in the EMA Territory.

“First Commercial Sale” means the first sale for monetary value for use or
consumption by the general public of a Licensed Product in a country in the
Territory after Health Registration Approval and Pricing Approval for such
Licensed Product has been obtained in such country.

“Force Majeure” has the meaning set forth in Section 19.1(a).

“Force Majeure Party” means a Party prevented or delayed in its performance
under this Agreement by an event of Force Majeure.

“GAAP” means generally accepted accounting principles in the United States,
consistently applied.

“Generic Product” means a product with the same active ingredient as the
Licensed Product and which is approved in reliance, in whole or in part, on the
applicable  Marketing Authorization of such Licensed Product as determined by
the applicable Health Authority under the provisions of Applicable Law in each
jurisdiction in the Territory.

“Government Authority” or “Government Authorities” means any federal, state,
national, regional, provincial or local government or political subdivision
thereof, or any multinational organization or any authority, agency or
commission entitled to exercise any administrative, executive, judicial,
legislative, police, regulatory or taxing authority or power, any court or
tribunal (or any department, bureau or division thereof, or any governmental
arbitrator or arbitral body).

“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 Development, Manufacture, use or
Commercialization of the Licensed Product in the Territory.

“Health Registration Approval” means, with respect to the Licensed Product in
any country in the Territory, any and all approvals, licenses, registrations or
authorizations of any Health Authority necessary for the commercial sale of such
Licensed Product in such country, including a Conditional Marketing
Authorization, Final Marketing Authorization, or other Marketing Authorization,
but excluding any pricing or reimbursement approvals.

“IFRS” means the International Financial Reporting Standards developed by the
International Accounting Standards Board, consistently applied.

“Indemnification Claim Notice” has the meaning set forth in Section 12.3.

“Indemnitee” has the meaning set forth in Section 12.3.

7/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

“Indemnitor” has the meaning set forth in Section 12.3.

“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, but excluding the Regulatory Documentation.

“Infringement Suit” has the meaning set forth in Section 15.2.

“Intellectual Property Rights” means Patents, Information, Trademarks,
copyrights (including rights in computer software), domain names, database
rights and any rights or property similar to any of the foregoing in any part of
the world, whether registered or not, together with the right to apply for the
registration of any such rights.

“Invalidity Action” has the meaning set forth in Section 15.1(a).

“Invention” means any invention, discovery, development or modification, whether
or not patented or patentable, including Information, 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 a Licensed Product, any discovery or development of any new or expanded
Indications for a Licensed Product, and any discovery or development that
improves the stability, safety or efficacy of a Licensed Product.

“Joint Inventions” has the meaning set forth in Section 9.2.

“JSC” has the meaning set forth in Section 3.1.

“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.

“Licensed Field” means all therapeutic, prophylactic and diagnostic uses in
humans.

“Licensed Know-How” means all Information, other than New NKTR-102 Data, that
(a) is Controlled by Nektar or its Affiliates as of the Effective Date or at any
time until the

8/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

end of the Term, and (b) is necessary or otherwise directly related to, the
Development or Commercialization of the Licensed Product.

“Licensed Patent Action” has the meaning set forth in Section 16.4.

“Licensed Patents” means (a) the Licensed Product Patents, and (b) any other
Patents granted or pending in a country or jurisdiction within the Territory
that are Controlled by Nektar or its Affiliates during the Term that have one or
more claims that Cover any Licensed Product or the use or sale thereof.

“Licensed Product” means the pharmaceutical product containing (i) NKTR-102
(free base), (ii) NKTR-102 derivatives, and (iii) any salts of (i) or (ii).

“Licensed Product Patents” means those patent applications set forth in Exhibit
A of this Agreement, and any patent granted in a country or jurisdiction within
the Territory that issues therefrom.

“Losses” means any and all costs, liabilities, losses, obligations, claims,
causes of action, damages, deficiencies, expenses, judgments, awards,
assessments or amounts paid in settlement, including interest, penalties, costs
of investigation and defense and reasonable attorneys’ fees and disbursements.

“MA” or “Marketing Authorization” means a marketing authorization issued by a
Health Authority to import, market and sell a Licensed Product in any country in
the Territory.

“MAA” means a marketing authorization application filed for Health Registration
Approval to import, market and sell a Licensed Product in any country in the
Territory.

“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 up to and
including the primary container, suitably labeled and packaged for storage and
transportation, in bulk quantities.  For clarity Manufacture and Manufacturing
does not include Packaging.

“Narrow Labeled Indication” means the following:  treatment of adult patients
with advanced breast cancer [***].

“Narrow Labeled Indication Population” means the number of patients in the EMA
Territory for the Narrow Labeled Indication, as of the Effective Date.

“Nektar Account” means [***]

“Nektar Core Technology” means technology encompassing (a) [***]; (b) [***]; (c)
[***]; (d) [***]; (e) [***]; and (f) [***].

“Nektar Core Technology Inventions” has the meaning set forth in Section 9.2(a).

9/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

“Nektar House Marks” means (i) the corporate logo of Nektar, (ii) the trademark
“NEKTAR”, (iii) any other trademark, trade name or service mark (whether
registered or unregistered) containing the word “NEKTAR”, and (iv) any other
trademark or service mark associated with goods or services of NEKTAR, but
excluding the Nektar Marks and trademarks, trade names or service marks
associated with goods or services outside the scope of this Agreement; and all
Intellectual Property Rights residing in any of the foregoing set forth in
Exhibit B-2 of this Agreement.

“Nektar Marks” means those Trademarks set forth in Exhibit B-1 this Agreement.

“Nektar Party” has the meaning set forth in Section 12.1.

“Net Sales” means the gross invoiced amount on sales of the Licensed Product by
Daiichi Sankyo, its Affiliates and Sublicensees to Third Parties (other than
Sublicensees) commencing on the First Commercial Sale.  Net Sales shall be
reduced by the following, to the extent included in the amount invoiced and
consistent with the internal audited systems of Daiichi Sankyo (or its
Affiliates or Sublicensees) in accordance with IFRS:

(a)customary trade and quantity discounts actually allowed or taken (and any
related wholesaler chargebacks actually allowed or taken);

(b)allowances actually given for returned Licensed Product;

(c)freight and insurance, if separately identified on the invoice;

(d)mandatory discounts or rebates imposed by any Government Authority against
Daiichi Sankyo or its Affiliates or Sublicensees (including any clawbacks or
similar pharma taxes directly related to the Licensed Product and paid directly
by Daiichi Sankyo or its Affiliates or Sublicensees, or, in the case of
clawbacks related to aggregate sales of Daiichi Sankyo or its Affiliates or
Sublicensees, such portion of the clawback as shall be reasonably determined by
Daiichi Sankyo based on the proportion between the share of Net Sales hereunder
and aggregate sales of Daiichi Sankyo);

(e)trade allowances or rebates, including any federal, state and/or local
government-mandated programs which qualify for or require a
manufacturer/distributor rebate;

(f)value-added tax, sales, use or turnover taxes, excise taxes and customs
duties assessed by Government Authorities on the sale of the Licensed Product;
and

(g)other reductions or specifically identifiable amounts deducted for reasons
similar to those listed above in accordance with IFRS; provided that no item
shall be deducted pursuant to this clause (g) if included in any other deduction
provided for under clauses (a)–(f) above.

10/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

Net Sales shall be deemed to accrue upon the date of the invoice for the
Licensed Product.  In addition, Daiichi Sankyo’s Net Sales hereunder are subject
to the following:

(i)In the case of pharmacy incentive programs involving the Licensed Product and
other products; hospital performance incentive program charge backs involving
the Licensed Product and other products; disease management programs or other
programs involving the Licensed Product and other products; or discounts on
“bundles” or any groups of products involving the Licensed Product and other
products, for the purpose of calculating Net Sales hereunder, all discounts and
the like shall be deemed to have been allocated equally among all products (the
Licensed Product and other products) as the basis on which such discounts and
the like were accrued, or if such basis cannot be determined, proportionately
based on the list price of such Licensed Product and other products (regardless
of the actual prices paid by the customer).  Notwithstanding the foregoing, in
the case of discounts on bundles or any groups of products involving the
Licensed Product and other products, if in any Calendar Quarter the discount
from list price offered for any Licensed Product is greater (in percentage
terms) than the discount offered from list price for any other product in the
same bundle or group of products, then for the purpose of calculating Net Sales
hereunder, all such discounted sales of the Licensed Product during such
Calendar Quarter shall be deemed to have been made at the list price for the
applicable Licensed Product during the relevant Calendar Quarter (regardless of
the actual prices paid by the customer).

(ii)In the case of any sale or other disposal of Licensed Product by Daiichi
Sankyo to an Affiliate, for resale, the Net Sales shall be calculated as set
forth above on the value received on the first arm’s length sale to a Third
Party.

(iii)In the event of a sublicense of Licensed Product, the Sublicensee’s Net
Sales will be calculated as set forth herein.

For the avoidance of doubt, sales between Daiichi Sankyo, its Affiliates and
Sublicensees shall not be considered Net Sales (unless such Person is the end
user of the Licensed Product), which shall be calculated as Net Sales of Daiichi
Sankyo, its Affiliates and Sublicensees independent of Third Party customers.

“New Indication” means an indication other than the Primary Indication.

“New NKTR-102 Data” means all data and other Information arising out of any
Clinical Studies of the Licensed Product conducted after the Effective Date
other than the BCBM Trial, that are conducted by or on behalf of Nektar or its
Affiliates or licensees, excluding any Clinical Studies conducted by or on
behalf of Daiichi Sankyo or its Affiliates or Sublicensees.

“NKTR-102” means [***].

“Non-Compete Arbitrator” has the meaning set forth in Section 2.5(b).

“Other Territory” means those countries in the Territory that are not subject to
the jurisdiction of the EMA, which as of the Effective Date, are Switzerland and
Turkey.

11/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

“Package” and “Packaging” means applying labeling as approved by the applicable
Health Authorities to each vial of the Licensed Product Manufactured and
supplied to Daiichi Sankyo by Nektar pursuant to the Supply Agreement and any
further packaging materials (cartons, shippers, dividers, etc.) and labeling
(including branding printed materials and text) that are specific to individual
markets or market segments within the Territory that is required to
Commercialize the Licensed Product in the Territory, including as required by
Health Authorities.

“Party” means either Daiichi Sankyo or Nektar and “Parties” means both Daiichi
Sankyo and Nektar.

“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, petty 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.

“Payments” has the meaning set forth in Section 7.4(e).

“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.

“Pharmacovigilance Agreement” has the meaning set forth in Section 6.7.

“Phase 1 Clinical Study” means a clinical study that generally provides for the
first introduction into humans of a pharmaceutical product with the primary
purpose of determining safety, metabolism and pharmacokinetic properties and
clinical pharmacology of such product, in a manner that is generally consistent
with 21 CFR § 312.21(a), as amended (or its successor regulation).

“Phase 2 Clinical Study” means a clinical study, the principal purpose of which
is to make a preliminary determination as to whether a pharmaceutical product is
safe for its intended use and to obtain sufficient information about such
product’s efficacy, in a manner that is generally consistent with 21 CFR §
312.21(b), as amended (or its successor regulation), to permit the design of
further Clinical Studies.

12/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

“Phase 3 Clinical Study” means a pivotal clinical study with a defined dose or a
set of defined doses of a pharmaceutical product designed to ascertain efficacy
and safety of such product, in a manner that is generally consistent with 21 CFR
§ 312.21(c), as amended (or its successor regulation), for the purpose of
enabling the preparation and submission of an MAA.

“Pricing Approvals” means, in any country where a Government Authority, as a
required condition precedent to the launch of Licensed Product or in order to
continue the marketing or sale of the Licensed Product following launch under
provisional pricing or reimbursement, authorizes reimbursement for, or approves
or determines pricing for, pharmaceutical products or medical devices, receipt
(or, if required to make such authorization, approval or determination
effective, publication) of such reimbursement authorization or pricing approval
or determination (as the case may be).

“Primary Indication” means BCBM.

“Prosecute” has the meaning set forth in Section 13.1.

“Publishing Party” means the Party permitted to make a publication or public
presentation under Section 10.7(a).

“Quality Agreement” has the meaning set forth in Section 6.7.

“Receiving Party” has the meaning set forth in Section 10.1.

“Regulatory Documentation” means all applications, registrations, licenses,
authorizations and approvals, all correspondence submitted to or received from
Health Authorities within the Territory (including minutes and official contact
reports relating to any communications with any Health Authority) and all
supporting documents, relating to the Licensed Product, and all data contained
in any of the foregoing, including all CTAs, Health Registration Approvals and
applications therefor, regulatory drug lists, advertising and promotion
documents, adverse event files and complaint files.

“Representatives” has the meaning set forth in Section 11.3(c)(i).  

“Research” means activities related to the design, discovery, generation,
identification, profiling, characterization, production, process development, or
cell line development of drug candidates and products, and shall include but not
be limited to any activity involving or related to the alteration of the
molecular structure of NKTR-102.

“Safety-Related Information” means information resulting from Daiichi Sankyo
Development activities or contained in New Nektar Data that has potential
relevance to the safety of the Licensed Product.

“Sensitive Information” has the meaning set forth in Section 18.5(b).

“Sole Invention” has the meaning set forth in Section 9.2.

13/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

“Sublicensee” has the meaning set forth in Section 2.3.

“Supply Agreement” has the meaning set forth in Section 8.1.

“Swiss MA” means the Health Registration Approval issued by the applicable
Health Authority for the Licensed Product for the Primary Indication in
Switzerland.

“Term” has the meaning set forth in Section 16.1.

“Termination Notice” has the meaning set forth in Section 16.2(a).

“Territory” means the European Economic Area as it may be constituted from time
to time, Switzerland and Turkey.

“Third Party” means any Person not including the Parties or the Parties’
respective Affiliates.

“Third Party Claim” has the meaning set forth in Section 12.1.

“Third Party Infringing Activities” has the meaning set forth in Section 14.1.

“Trademark” means all trademarks, service marks, registrations, and applications
therefor.

“United States” or “U.S.” means the United States of America, its territories
and possessions.

“Valid Claim” means, with respect to a Licensed Product in a particular country,
any claim of a Licensed Patent that:

(a)with respect to a granted and unexpired Licensed Patent in such country, (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, was filed and is being
prosecuted in good faith and has not been abandoned or finally disallowed
without the possibility of appeal or re-filing of the application, provided that
with respect to (i) pending Licensed Patent applications (a) and (b) identified
on Exhibit A, such claim has not been pending for more than [***] years from the
Effective Date, and (ii) any other pending Licensed Patent applications, such
claim has not been pending for more than [***] years.

1.2Interpretation.  Except where the context requires otherwise, whenever used
the singular includes the plural, the plural includes the singular and the use
of any gender is applicable to all genders.  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

14/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

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. 

2.Grant of Rights.

2.1License Grants to Daiichi Sankyo.

(a)Licensed Patents, Licensed Know-How and Regulatory Documentation.  Subject to
the terms and conditions of this Agreement, during the Term, Nektar hereby
grants to Daiichi Sankyo a sublicensable (subject to Section 2.3),
non-transferable (subject to Section 18.6), exclusive (even as to Nektar)
license under the Licensed Patents, the Licensed Know-How and the Regulatory
Documentation solely to Commercialize the Licensed Product in the Territory for
any and all indications.  Subject to the terms and conditions of this Agreement,
during the Term, Nektar hereby grants to Daiichi Sankyo a sublicensable (subject
to Section 2.3), non-transferable (subject to Section 18.6), co-exclusive
license under the Licensed Patents, the Licensed Know-How and the Regulatory
Documentation solely to Develop and Package the Licensed Product in the
Territory for any and all indications.

(b)Nektar Marks.  Subject to the terms and conditions of this Agreement, during
the Term, Nektar hereby grants to Daiichi Sankyo a sublicensable (subject to
Section 2.3), non-transferable (subject to Section 18.6), exclusive (even as to
Nektar) license under the Nektar Marks solely to Package and Commercialize the
Licensed Product in the Territory.

(c)Nektar House Marks.  Subject to the terms and conditions of this Agreement,
during the Term, Nektar hereby grants to Daiichi Sankyo a sublicensable (subject
to Section 2.3), non-transferable (subject to Section 18.6), non-exclusive,
royalty-free license under the Nektar House Marks solely to Package and
Commercialize the Licensed Product in the Territory.

2.2Retained Rights.  For the avoidance of doubt, notwithstanding the provisions
of Section 1.2 or any other provision of this Agreement, Nektar shall retain
rights under the Licensed Patents, Licensed Know-How, Regulatory Documentation,
Nektar Marks and Nektar House Marks to (a) perform its responsibilities under
this Agreement or any Ancillary Agreement; and (b) Develop and Manufacture the
Licensed Product in the Territory for purposes of the Development of the
Licensed Product worldwide and Commercialization of the Licensed Product outside
the Territory.

2.3Sublicenses.  Daiichi Sankyo shall have the right to grant sublicenses solely
in furtherance of existing Daiichi Sankyo’s rights under this Agreement to (i)
its Affiliates (ii) distributors selected by Daiichi Sankyo, and (iii) contract
sales agents and organizations acting on behalf of Daiichi Sankyo, in each case
of the foregoing (i) through (iii) (inclusive), at Daiichi Sankyo’s sole
discretion and without obtaining the prior written consent of or providing prior

15/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

notice to Nektar.  In addition, Daiichi Sankyo shall have the right to grant
sublicenses to other Third Parties solely in furtherance of exercising Daiichi
Sankyo’s rights under this Agreement after obtaining Nektar’s prior written
consent, not to be unreasonably withheld.  Each such sublicensee, whether an
Affiliate or a Third Party, shall be a “Sublicensee” hereunder.  Any such
Sublicensee shall be obligated in writing, as a condition to the grant of such
sublicense, (a) to be bound by provisions with respect to non-disclosure and
non-use which are at least as restrictive as those provisions that are set forth
in this Agreement and (b) to comply with all applicable terms and conditions of
this Agreement.  Daiichi Sankyo 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 Daiichi Sankyo would be a breach of this Agreement, will be deemed
a breach by Daiichi Sankyo of this Agreement for which Daiichi Sankyo is
responsible. 

2.4License Limitations.  Nothing in this Agreement will grant (or be construed
to grant) to Daiichi Sankyo any right to make, have made, use, offer for sale,
sell, import or otherwise exploit any products other than the Licensed Product
for the Agreed Indication in the Territory in accordance with the terms and
conditions of this Agreement. Daiichi Sankyo shall not, and shall cause its
Affiliates and Sublicensees not to, use or practice any Licensed Know-How,
Regulatory Documentation, Licensed Patents, Nektar Marks or Nektar House Marks
in any manner whatsoever except to the extent expressly licensed or permitted
under this Agreement.

2.5Non-compete.  During [***], Daiichi Sankyo shall not, and shall cause its
Affiliates not to, Commercialize a Competing Product in [***]. Daiichi Sankyo
shall not be deemed to have breached Section 2.5, and shall have no obligation
to provide compensation to Nektar hereunder, if Daiichi Sankyo acquires a Person
that is Commercializing a Competing Product in [***] at the time of the
acquisition, and within [***] of the acquisition, ceases its Commercialization
of the Competing Product in [***]. In the event that Nektar believes Daiichi
Sankyo has breached Section 2.5, Nektar shall promptly notify Daiichi Sankyo,
including in the notice a summary of the material facts underlying the Nektar
belief.  Daiichi Sankyo shall have [***] to respond to the notice from Nektar.

(a)If Daiichi Sankyo agrees that it has breached Section 2.5, then it shall
promptly cease all activities that constitute the breach and provide Nektar with
written confirmation that it has done so.  The Parties shall designate
representatives to determine the amount of compensation due to Nektar for the
breach of Section 2.5 by Daiichi Sankyo.  If the Parties agree on the amount of
compensation due to Nektar, then Daiichi Sankyo shall pay such amount to Nektar
within [***] of receipt by Daiichi Sankyo of an invoice from Nektar for such
amount.  In the event that the Parties are unable to agree on the amount of
compensation due to Nektar within [***] following the initiation of their
discussions, then the amount shall be determined as outlined in Section 2.5(c)
below.  

(b)If Daiichi Sankyo disagrees that it has breached Section 2.5, then the
dispute shall be independently determined by a third party expert with
significant experience and expertise in the oncology market in [***] (the
“Non-Compete Arbitrator”), with the selection of such Non-Compete Arbitrator to
be mutually agreed by the Parties in good faith and the costs of such
arbitration to be [***].  Each of the Parties shall submit its position on the
breach

16/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

outlined in the Nektar notice to the Non-Compete Arbitrator within [***] after
the Non-Compete Arbitrator is appointed, and the Non-Compete Arbitrator shall
issue a determination as to whether Daiichi Sankyo has breached Section 2.5
within [***] of the last submission of the Parties.  The decision of the
Non-Compete Arbitrator shall be binding on both Parties, and shall be final,
unappealable and subject to enforcement by any court of competent jurisdiction.
 

(c)In the event that the Non-Compete Arbitrator decides in Nektar’s favor, then
Daiichi Sankyo shall promptly cease all activities that constitute the breach
and provide Nektar with written confirmation that it has done so, and the
Parties shall designate representatives to determine the amount of compensation
due to Nektar for the breach of Section 2.5 by Daiichi Sankyo.  In the event
that the Parties are unable to agree on the amount of compensation due to Nektar
within [***] following the decision of the Non-Compete Arbitrator on the
question of breach, then the amount of compensation due to Nektar shall also be
independently determined by the Non-Compete Arbitrator.  By a date set by the
Non-Compete Arbitrator, each of the Parties shall submit its estimate of the
compensation due to Nektar, and the Non-Compete Arbitrator shall issue a
determination within [***] of the last submission of the Parties selecting the
estimate submitted by the Party which is closest to the Non-Compete Arbitrator’s
independent estimate of the compensation due to Nektar.  The Party’s estimate
selected by the Non-Compete Arbitrator shall be binding on both Parties for the
determination of the amount to be paid by Daiichi Sankyo to Nektar in
compensation for the breach of Section 2.5 by Daiichi Sankyo, shall be paid by
Daiichi Sankyo within [***] of receipt by Daiichi Sankyo of an invoice from
Nektar for such amount, and shall be final, unappealable and subject to
enforcement by any court of competent jurisdiction.

(d)The rights set forth in Section 2.5(a), Section 2.5(b) and Section 2.5(c)
shall be Nektar’s sole and exclusive remedy for a breach of Section 2.5.  For
clarity, (i) Nektar shall not have any right to seek a remedy (including to seek
termination of this Agreement) under Section 16.2(a); and Section 19.9(b) shall
not apply in respect of any breach of Section 2.5 or otherwise with respect to
Section 2.5.

2.6No Implied Licenses.  Except as specifically set forth in this Agreement,
neither Party shall acquire any license or other right or interest, by
implication or otherwise, in any Intellectual Property Rights of the other Party
or any of its Affiliates.

2.7Territory/Outside the Territory.

(a)Ex-Territory Sales. To the extent permitted by Applicable Laws, Daiichi
Sankyo will not, and will cause its Affiliates and Sublicensees not to, actively
sell the Licensed Product outside the Territory.  For greater certainty, Daiichi
Sankyo shall not be in breach of this Agreement only by reason that an end-user
purchases a Licensed Product in the Territory and uses it outside the Territory.

(b)Territory Sales. To the extent permitted by Applicable Laws, Nektar will not,
and shall require its licensees Commercializing the Licensed Product outside the
Territory  not to, actively sell the Licensed Product in the Territory.  For
greater certainty, Nektar shall not

17/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

be in breach of this Agreement only by reason that an end-user purchases a
Licensed Product outside the Territory and uses it in the Territory. 

(c)Interpretation.  For purposes of this Section 2.7, “actively sell” shall be
interpreted in accordance with European Commission Regulation (EU) No 330/2010
and the Commission Notice entitled “Guidelines on Vertical Restraints,” as the
same may be amended from time to time.

3.Governance.

3.1JSC Formation and Responsibilities.  Within [***] following the Effective
Date, the Parties will establish a joint steering committee (the “JSC”), to
oversee, review, and coordinate the Development of the Licensed Product for the
Territory and Manufacturing (and related supply chain matters) of the Licensed
Product for the Territory.  Specifically, the JSC shall:

(a)review and approve the Development activities to be conducted by the Parties
hereunder, including (i) reviewing and approving any Clinical Study conducted in
support of receiving the Conditional Marketing Authorization, Final Marketing
Authorization, or any other Health Registration Approval for the Licensed
Product in the Territory; and (ii) reviewing and approving any Development
Plans;

(b)review and approve the regulatory activities to be conducted by the Parties
hereunder and regulatory strategies with respect to the Development of the
Licensed Product in the Territory, including (i) the preparation and submission
of the Conditional MAA seeking Conditional Marketing Authorization and any
supplements or renewals thereof, including whether to pursue the Narrow Labeled
Indication or the Broad Labeled Indication; (ii) the preparation and submission
of the MAA seeking Final Marketing Authorization, including whether to pursue
the Narrow Labeled Indication or the Broad Labeled Indication; and (iii) the
preparation and submission of any other MAA seeking Health Registration Approval
for the Licensed Product in the Territory;

(c)serve as a forum for the Parties to exchange information with respect to the
progress of the Development and Manufacturing of the Licensed Product in the
Territory;

(d)serve as a forum for the Parties to exchange information provided under
Article 5 with respect to the progress of the Commercialization of the Licensed
Product in the Territory;

(e)make such other decisions as may be delegated to the JSC pursuant to this
Agreement or by written agreement of the Parties; and

(f)establish other working groups to implement the foregoing responsibilities,
which working groups shall have such responsibilities, and be comprised of such
number of representatives from each of the Parties with such expertise and
seniority, as the JSC may direct from time to time, supervising and directing
the activities of such working groups and reviewing reports and recommendations
from such working groups.  Promptly following the

18/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

Effective Date, the JSC will establish working groups with responsibility for
each of the following areas: Development (industry regulatory matters),
publication, and Manufacturing (including supply chain and regulatory matters). 

3.2Membership.  Each Party shall, within [***] after the Effective Date,
designate [***] to serve as their initial members of the JSC, each with the
requisite experience and seniority in the Development and Manufacture of
pharmaceutical products in the Territory to make decisions on behalf of the
Parties with respect to issues falling within the jurisdiction of the JSC.  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 the JSC, by giving written notice to the other Party.  Each
Party may invite non-voting representatives to attend JSC meetings; provided
that such Party provides advance notice to the other Party of such attendance
and such non-voting representatives are bound by confidentiality and non-use
obligations no less restrictive than those set forth in this Agreement.

3.3Meetings and Quorum.  The JSC 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 the JSC shall exist whenever
there is present at a meeting at least [***] appointed by each Party.  The JSC
shall take action by consensus of the representatives present at a meeting at
which a quorum exists, with, subject to the final decision-making authority of
the JSC as set forth in Section 3.4, each Party collectively having a single
vote irrespective of the number of representatives of such Party in attendance
or by a written resolution signed by at least [***] appointed by each Party.

(a)Timing and Attendance at Meetings.  The JSC shall establish a schedule of
times for regular meetings.  The JSC shall meet at least [***] or as more or
less often as otherwise agreed to by the Parties.  In addition, either Party may
call a meeting of the JSC upon reasonable notice to the other Party where such
meeting is reasonably necessary to fulfill the JSC’s responsibilities under this
Agreement.  The location of JSC meetings, when in person, shall alternate
between the offices of Nektar and Daiichi Sankyo, unless otherwise agreed to by
the Parties.  Members of the JSC 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 also be allowed.

(b)Chairs.  The JSC shall have [***], with each Party electing [***].  [***] of
the [***] shall have any greater authority than any other representative to the
JSC.

(c)Minutes.  The JSC 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 JSC members promptly after the
meeting, and the Parties’ chairs shall alternate responsibility for the
preparation and circulation of the draft minutes.  The minutes shall be deemed
approved upon the approval of such minutes by the co-chairs.  Upon approval,
final minutes shall be circulated to the members of the JSC by the co-chairs.

19/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

(d)Expenses.  Each Party shall bear all costs of its representatives on the JSC
related to their participation on the JSC and attendance at JSC meetings. 

3.4Decision-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, the matter in dispute shall be referred to
the Executives who shall confer within [***] after such matter was first
referred to them to attempt to resolve the matter in dispute by good faith
negotiations.  If such dispute is not resolved by the Executives following good
faith negotiations within [***] after the Executives first confer on such
matter, then Nektar shall have the right to make the final decision with regard
to all disputed matters falling within the decision-making authority of the JSC;
it being understood that all matters related solely to the Commercialization of
the Licensed Product in the Territory are outside the decision-making authority
of the JSC.  For the avoidance of doubt, JSC involvement in the preparation and
submission of the MAA seeking Final Marketing Authorization, including whether
to pursue the Narrow Labeled Indication or the Broad Labeled Indication, and any
decisions made under this Section 3 in connection therewith shall be without
prejudice to Daiichi Sankyo’s rights under Sections 7.2(b) or 16.2(c).

3.5Limitations 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 the JSC unless such delegation or
vesting of rights is expressly provided for in this Agreement or the Parties
expressly so agree in writing.  Notwithstanding the foregoing or anything else
to the contrary, the JSC shall not have the power to (a) amend, modify or waive
compliance with this Agreement or any Ancillary Agreement; (b) cause a Party to
take on additional obligations, including financial obligations, over such
Party’s objections; (c) determine that either Party has fulfilled any obligation
under this Agreement or that either Party has breached any obligation under this
Agreement or make any other determination with respect to a Legal Matter; or (d)
to expand the scope of its authority or determine any issue before the JSC in a
manner that would conflict with the express terms of this Agreement.

4.Development.

4.1BCBM Trial.  Nektar shall, at its own expense, use Commercially Reasonable
Efforts to conduct the BCBM Trial with the Licensed Product for the Primary
Indication in accordance with the BCBM Trial Protocol in effect as of the
Effective Date, and in a good scientific manner and in compliance with
Applicable Law.  Notwithstanding the foregoing, the JSC will have the right to
modify the BCBM Trial Protocol from time to time as reasonably necessary based
on, among other concerns, interactions with Health Authorities, feedback from
sites participating in the BCBM Trial Protocol, as well as any study
feasibility, safety, regulatory, and commercial considerations.  Nektar shall
keep Daiichi Sankyo reasonably and promptly apprised of its activities in
respect of the BCBM Trial through Daiichi Sankyo’s representatives on the JSC.
Notwithstanding anything to the contrary in this Agreement, and excluding the
BCBM Trial, Nektar shall not have any obligation to undertake or support any
other Development of the Licensed Product in any field, for any use or in any
jurisdiction.

20/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

4.2Development by Daiichi Sankyo.  If Daiichi Sankyo desires to conduct
additional Development of the Licensed Product for the Primary Indication or any
New Indication in the Territory, Daiichi Sankyo shall provide Nektar with
written notice of such interest and a written plan with respect to the
activities to be undertaken by Daiichi Sankyo in connection with such proposed
Development activities (the “Development Plan”).  No Clinical Study or any other
Development activity in respect of a Licensed Product shall be conducted by or
on behalf of Daiichi Sankyo without the prior written approval of Nektar, such
approval not to be unreasonably withheld (which approval, for the avoidance of
doubt, may not, except as provided under Section 4.5, be conditioned on the
imposition of additional payments that would be due to Nektar).  Daiichi Sankyo
will, at its own expense, conduct any such Development in accordance with the
applicable Development Plan in a good scientific manner and in compliance with
Applicable Law.  Notwithstanding anything to the contrary in this Agreement,
Daiichi Sankyo shall not have any obligation to undertake or support any
Development of the Licensed Product in any field, for any use or in any
jurisdiction. At Nektar’s option, Nektar and its licensees outside the Territory
shall have the right to use Information generated by Daiichi Sankyo in the
course of executing any Development Plan hereunder for any legal purpose
provided there is a mutual agreement in writing of the Parties on appropriate
cost sharing, such agreement to be entered into at the time the Nektar consent
to the Development by Daiichi Sankyo is granted, or at any later time as
mutually agreed by the Parties.  If the Parties are not able to agree on such
cost sharing, then other than with respect to Safety-Related Information, Nektar
and its licensees outside the Territory shall have no right to use such Daiichi
Sankyo Information.  Nektar and its licensees outside the Territory may, at no
cost and without making any payments to Daiichi Sankyo, use any and all
Safety-Related Information generated by Daiichi Sankyo in submissions for Health
Registration Approval and in other Regulatory Documentation and in filings with
Health Authorities, in each case outside the Territory in connection with the
Licensed Product. 

4.3Development Reporting.  Each Party shall keep the other Party reasonably and
[***] apprised of its planned as well as undertaken Development activities under
Section 4.1 and 4.2 (as well as through Nektar’s reservation of rights under
Section 2.2 in respect of any New NKTR-102 Data and Development activities
giving rise to such data) respectively, through its representatives on the JSC,
and will provide such additional information, including copies of Regulatory
Documentation, and reports as reasonably requested by a JSC member to enable the
JSC to assess progress with respect to such Development activities.  Each Party
shall provide (a) an update to the JSC at each JSC meeting regarding all such
Development efforts since the last meeting, and describing the results of such
activities and progress of such Development, and strategy and plans for the
Development efforts for the following year; and (b) an [***] written report
(using a format specified by the JSC) on such Development activities, including
a detailed summary of the applicable Development activities planned to be
conducted in the next [***].

4.4Records of Development Activities.  Each Party shall maintain, and shall
cause its Affiliates and sublicensees to maintain, complete and accurate records
of all Development activities under this Agreement in such detail as typically
recorded by such Party for its own similar products, and which shall be retained
by such Party for at least [***] after the termination of this Agreement, or for
such longer period as may be required by Applicable Law.

21/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

4.5New NKTR-102 Data.  Other than with respect to Safety-Related Information,
Daiichi Sankyo shall have no rights to, and Nektar shall have no obligation to
grant to Daiichi Sankyo, for use in a submission for Health Registration
Approval, any New NKTR-102 Data generated from such Development without Nektar’s
prior written consent, which consent is expressly conditioned upon mutual
agreement of the Parties on appropriate cost sharing and other business terms
with respect to Clinical Studies or other Development activities giving rise to
such New NKTR-102 Data.  Daiichi Sankyo may, at no additional cost and without
making any additional payments to Nektar, use any and all Safety-Related
Information of Nektar in submissions for Health Registration Approval and in
other Regulatory Documentation and in filings with Health Authorities, in each
case in connection with the Licensed Product for the Approved Indications. 

4.6Post MA Approval Obligations Imposed by Health Authorities.  Until the
receipt of Final Marketing Authorization in the EMA Territory, subject to
Nektar’s right to terminate this Agreement pursuant to Section 16.2(g), Nektar
shall be solely responsible for undertaking, at its cost and expense, all
post-approval commitments and obligations imposed by the Health Authority in the
EMA Territory with respect to the Licensed Product under the Conditional
Marketing Authorization.  If the Swiss Health Authority grants Conditional
Marketing Authorization for the Licensed Product, then until the receipt of
final marketing authorization in Switzerland, subject to Nektar’s right to
terminate this Agreement pursuant to Section 16.2(g), Nektar shall be solely
responsible for undertaking, at its cost and expense, all post-approval
commitments and obligations imposed by the Health Authority in Switzerland with
respect to the Licensed Product under the Conditional Marketing Authorization.
If the Turkish Health Authority grants Conditional Marketing Authorization for
the Licensed Product, then until the receipt of final marketing authorization in
Turkey, Daiichi Sankyo shall be solely responsible for undertaking, at its cost
and expense, all post-approval commitments and obligations imposed by the Health
Authority in Turkey with respect to the Licensed Product under the Conditional
Marketing Authorization. From and after the receipt of each of the Final
Marketing Authorization in a country in the Territory Daiichi Sankyo shall be
solely responsible for undertaking, at its cost and expense, all post-approval
commitments and obligations imposed by the applicable Health Authorities with
respect to the Licensed Product in such country in the Territory.

5.Commercialization.

5.1Allocation of Responsibilities.  Subject to the terms and conditions of this
Agreement or any Ancillary Agreement, Daiichi Sankyo shall have the sole right
and responsibility, at its sole expense, to Commercialize the Licensed Product
for the Primary Indication in the Territory.

5.2Primary Indication.  Within [***] of the Effective Date, Daiichi Sankyo shall
deliver to Nektar an initial written plan setting forth a summary of the
anticipated activities to be undertaken by Daiichi Sankyo in connection with the
Commercialization of the Licensed Product (the “Commercialization Plan”) for the
Primary Indication in the Territory, excluding any information relating to
pricing or reimbursement submissions (including Pricing Approvals).  The
Commercialization Plan shall include an outline of the Commercialization
activities for the

22/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

Licensed Product for the Primary Indication in the Territory, including (a)
[***], (b) [***], (c) [***], (d) [***] (e) [***].  Thereafter, and no later than
[***], Daiichi Sankyo will update the Commercialization Plan on an [***] basis,
including any changes required to take into account ongoing Development
activities, including the BCBM Trial. 

5.3New Indications.  Subject to the terms and conditions of this Agreement,
including Article 4 or any Ancillary Agreement, Daiichi Sankyo shall have the
sole right and responsibility, at its sole expense, to Commercialize the
Licensed Product for any New Indication that has been approved for Development
as an Agreed Indication for Commercialization in the Territory pursuant to the
terms of this Agreement, and will provide Nektar with an updated
Commercialization Plan reflecting the Commercialization activities within the
Territory with respect to Commercialization of the Licensed Product for such New
Indication.

5.4Commercialization Diligence.  Daiichi Sankyo shall use Commercially
Reasonable Efforts, at its own cost and expense, to promote, market, sell and
otherwise Commercialize the Licensed Product in such countries in the Territory
where the relevant factors to such Commercially Reasonable Efforts sufficiently
support doing so.

5.5Commercialization Reporting.  Commencing as of the [***] and continuing
thereafter during the Term, Daiichi Sankyo shall provide Nektar with (a) an
update at each [***] JSC meeting with respect to Daiichi Sankyo’s
Commercialization-related activities related to the Licensed Product in the
Territory; and (b) an [***] summary written report on the Commercialization
activities undertaken by Daiichi Sankyo with respect to the Licensed Product in
the Territory [***].

6.Regulatory Matters.

6.1Nektar Responsibilities for MAAs and MAs.

(a)EMA Territory.  Subject to the other provisions of this Article 6, including
Section 6.2, Nektar shall have the sole right and responsibility, at its sole
expense, to prepare and submit the applications for Conditional Marketing
Authorization and Final Marketing Authorization, and make all other related
submissions with the applicable Health Authority for the Licensed Product in the
EMA Territory, as well as to conduct all correspondence and communications with
such Health Authority regarding such matters.  Nektar will use Commercially
Reasonable Efforts to prepare and submit in a timely manner, (i) the Conditional
MA seeking Conditional Marketing Authorization for the Licensed Product in the
EMA Territory, including all annual renewals thereto, until [***]; and (ii) if
applicable, [***].  Nektar shall keep Daiichi Sankyo reasonably informed of the
submissions for Conditional Marketing Authorization in the EMA Territory and
Final Marketing Authorization, including any major supplements or amendments
thereto and the progress of such submissions.  Nektar hereby designates Daiichi
Sankyo to be its “local representative” in each jurisdiction in the Territory
for purposes, amongst others, of seeking to obtain, and to hold and maintain
Pricing Approvals for the Licensed Product.  Nektar shall reasonably cooperate
with Daiichi Sankyo in connection therewith, including executing such documents
as may be necessary to confirm its status as such

23/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

local representative.  Daiichi Sankyo shall submit all necessary applications
and documentation to seek to obtain, hold and maintain Pricing Approvals, and
shall do so in the manner determined by Daiichi Sankyo.   

(b)Switzerland.  Subject to the other provisions of this Article 6, including
Section 6.2, Nektar shall have the sole right and responsibility, at its sole
expense, to prepare and submit the applications for the Swiss MA, and make all
other related submissions with Health Authorities, for the Swiss MA as well as
to conduct all correspondence and communications with Health Authorities
regarding all such matters.  Nektar will use Commercially Reasonable Efforts to
prepare and submit in [***], such MAAs with the applicable Health Authority
seeking the Swiss MA, including, if applicable, the MAA seeking Conditional
Marketing Authorization; provided however, that Nektar will only be required to
submit an MAA based on the data generated from the BCBM Trial and the
information supplied to the EMA in connection with the Conditional Marketing
Authorization or Final Marketing Authorization in the EMA Territory and Nektar
shall not be obligated to conduct any Clinical Studies or other Development
activities in support of any such MAA.  Nektar shall keep Daiichi Sankyo
reasonably informed of the submissions of such MAAs for the Swiss MA, including
any major supplements or amendments thereto and the progress of such
submissions.

(c)[***].

(d)Transfer of Marketing Authorizations.  [***] of each of the Final Marketing
Authorization and the Swiss MA, subject to the terms and conditions of this
Agreement, Nektar shall transfer and assign to Daiichi Sankyo any and all right,
title, and interest in and to such Final Marketing Authorization and the Swiss
MA, and Nektar will [***] submit to the applicable Health Authorities a letter
(with a copy to Daiichi Sankyo) or other communication required by the
applicable Health Authorities, notifying such Health Authorities of each such
transfer.

6.2Daiichi Sankyo Responsibilities for MAAs and MAs.

(a)EMA Territory and Switzerland.  Except as provided in Section 6.1 above and
subject to the other provisions of this Article 6, Daiichi Sankyo shall have the
sole right and responsibility, at its sole discretion and expense, to (i)
prepare and submit the applications for any Health Registration Approval, and
make all other related submissions with Health Authorities for the Licensed
Product in the EMA Territory and Switzerland in connection with any additional
Development activities undertaken pursuant to Article 4 [***], and (ii) maintain
and renew all Health Registration Approvals for the Licensed Product for the
Agreed Indications in the EMA Territory and Switzerland, including the Final
Marketing Authorization and Swiss MA, as well as in the case of each of (i) and
(ii) to conduct all correspondence and communications with Health Authorities
regarding such matters.  Daiichi Sankyo shall use Commercially Reasonable
Efforts to conduct its activities hereunder, and shall keep Nektar reasonably
informed of any submissions hereunder, including any supplements or amendments
thereto and the progress of all such submissions.  Without limiting the
foregoing, in no event will Daiichi Sankyo allow any Health Registration
Approval related to the Licensed Product in the

24/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

EMA Territory or Switzerland to lapse, expire or otherwise terminate without
Nektar’s prior written consent. 

(b)Turkey.  Subject to the other provisions of this Article 6, Daiichi Sankyo
shall have the sole right, at its sole discretion and expense, to (i) prepare
and submit the applications for Health Registration Approval, including any such
submissions with Health Authorities for the Licensed Product in Turkey in
connection with the Primary Indication or any additional Development activities
undertaken pursuant to Article 4, and (ii) maintain and renew all Health
Registration Approvals for the Licensed Product for the Agreed Indications in
Turkey, as well as in the case of each of (i) and (ii) to conduct all
correspondence and communications with Health Authorities regarding all such
matters.  Daiichi Sankyo will use Commercially Reasonable Efforts to prepare and
submit in a timely manner such MAAs with the applicable Health Authority seeking
Health Registration Approval for the Licensed Product for the Primary Indication
in Turkey; provided however, that neither Nektar nor Daiichi Sankyo shall be
obligated to conduct any Clinical Studies or other Development activities in
support of any such MAA in Turkey.  Upon Daiichi Sankyo’s request, Nektar agrees
to provide reasonable assistance to Daiichi Sankyo to obtain any required Health
Registration Approvals for the Licensed Product for the Agreed Indications in
Turkey.  Daiichi Sankyo shall keep Nektar reasonably informed of any submissions
hereunder, including any supplements or amendments thereto and the progress of
all such submissions.  Without limiting the foregoing, in no event will Daiichi
Sankyo allow any Marketing Authorization related to the Licensed Product in
Turkey to lapse, expire or otherwise terminate without Nektar’s prior written
consent.

(c)Pricing Approvals.  Subject to the terms and conditions of this Agreement,
Daiichi Sankyo shall have the sole right, at its sole expense, to, and shall
[***] prepare and submit all necessary applications and documentation to seek to
obtain, hold and maintain Pricing Approvals for the Licensed Product for the
Agreed Indications in the Territory, as well as to conduct all correspondence
and communications with Government Authorities regarding all such
matters.  Nektar shall reasonably cooperate with Daiichi Sankyo in connection
therewith, including executing such documents as may be necessary to confirm
Daiichi Sankyo’s rights to prepare, submit, and obtain such Pricing Approvals
for the Licensed Product for such Agreed Indications in the Territory.

6.3Right of Reference.  Daiichi Sankyo hereby grants Nektar and its Affiliates
and sublicensees the right and license to access, cross-reference, file or
incorporate by reference, any MA held by or on behalf of Daiichi Sankyo or its
Affiliates or Sublicensees with respect to the Licensed Product in the
Territory, including all data and other information included or referenced
therein, to support submission to Health Authorities and other regulatory
authorities outside the Territory.  Upon request, Daiichi Sankyo shall issue a
letter of authorization or other documentation to allow Nektar to effectuate
such right of access to such MAs.

6.4Opportunity to Comment on Regulatory Submissions.  Without limiting the
foregoing, each Party shall, in connection with its obligations under this
Article 6, provide the other Party with a reasonable opportunity to review and
comment prior to submission upon (a) any regulatory communications with any
Health Authority with respect to the Licensed Product in the Territory or with
respect to Manufacturing globally (other than any such communications

25/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

that are purely ministerial in nature), and (b) all regulatory filings and
submissions, including Health Registration Approvals, but excluding Pricing
Approvals, for a Licensed Product that are made to any Health Authority in the
Territory.  Notwithstanding the foregoing: (i) Nektar shall be entitled to make
the final determination with respect to the content of any communications,
filings, submissions and/or applications (A) related to Manufacturing, and (B)
related to the Final Marketing Authorization and the Swiss MA prior to the
transfer date of the Final Marketing Authorization and the Swiss MA,
respectively, following good faith consideration of any comments and suggestions
that Daiichi Sankyo may have; and (ii) Daiichi Sankyo shall be entitled to make
the final determination with respect to the content of any such communications,
filings, submissions and/or applications for which Daiichi Sankyo is responsible
for making under Section 6.2, following good faith consideration of any comments
and suggestions that Nektar may have.  For the avoidance of doubt, Nektar shall
not have a role in determining how Daiichi Sankyo will go about seeking, holding
or maintaining the Pricing Approvals for the Licensed Product for the Agreed
Indications in the Territory. 

6.5Written Communications with Health Authorities.  Each Party shall promptly
provide the other Party with copies of all material written or electronic
communications received by it, its Affiliates or sublicensees from any Health
Authorities within the Territory with respect to the Manufacture, Development or
Commercialization of the Licensed Product in the Territory under this
Agreement.  Such material communications shall be provided by a Party [***] but
in any event within [***] of such receipt; provided that [***] as used in the
foregoing, shall in addition to the days specified in the definition of [***] in
Section 1.1, also provide for any additional days to take into account any
applicable days on which national banks in the country in which the applicable
Health Authority is located are generally permitted or required to be closed.

6.6Meetings with Health Authorities.  To the extent practicable, Nektar or
Daiichi Sankyo, as the case may be, shall [***] provide the other Party with
prior written or email notice of all meetings, conferences and discussions that
are scheduled with any Health Authorities within the Territory regarding its
activities with respect to the Licensed Product in the Territory under this
Agreement within [***] after such Party 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 the other
Party a reasonable opportunity to attend such meeting, conference or
discussion); provided that [***] as used in the foregoing, shall in addition to
the days specified in the definition of [***] in Section 1.1, also provide for
any additional days to take into account any applicable days on which national
banks in the country in which the applicable Health Authority is located are
generally permitted or required to be closed.  Each Party shall be entitled to
have [***] of its representatives present at such meeting, conference or
discussion, with the opportunity to participate (provided that a Party shall be
entitled to have [***] of its representatives present if the applicable Health
Authority limits the number of participants in a meeting).  Each Party shall in
good faith take into account the schedules of the representatives of the other
Party in scheduling any such meetings, conferences or discussions.  Nektar or
Daiichi Sankyo, as the case may be, shall [***] forward to the other Party
copies of all meeting minutes and summaries of all such meetings, conferences
and discussions with such Health Authority.

26/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

6.7Pharmacovigilance and Quality Agreements.  Within [***] following the
Effective Date, the Parties shall negotiate in good faith and enter into a
pharmacovigilance agreement and a quality agreement, as provided below.  

(a) The pharmacovigilance agreement (“Pharmacovigilance Agreement”) shall be
entered into on reasonable and customary terms and conditions with respect to
the use of the Licensed Product in the Territory, and shall govern the Parties’
respective responsibilities with respect to reporting to the applicable Health
Authorities any Adverse Events, complaints and other safety-related matters,
with (i) Nektar responsible for such activities at its own cost outside the
Territory at all times and in the Territory, until the receipt of the
Conditional Marketing Authorization in the EMA Territory; and (ii) Daiichi
Sankyo responsible for such activities at its own cost in the Territory, [***].
The foregoing allocation of responsibilities is subject to the following:  (A)
[***], Daiichi Sankyo shall be responsible for investigating, creating records
relating to, compiling safety-related reports (including Adverse Events), and
preparing and transmitting to Nektar submissions intended for the Health
Authority; (B) Nektar, as the holder of the Conditional Marketing Authorization,
shall be responsible for submitting to the Health Authority safety-related
reports and other submissions prepared by Daiichi Sankyo on Nektar’s behalf; (C)
[***] Daiichi Sankyo, as the holder of the Final Marketing Authorization, shall
be responsible for submitting safety-related reports and other submissions to
the Health Authority; and (D) if the Swiss Health Authority grants conditional
marketing authorization to Nektar for the Licensed Product, then (A) and (B)
shall also be applicable for Switzerland while [***], and (C) shall be
applicable to Switzerland [***].

(b) The quality agreement (“Quality Agreement”) shall be entered into on
reasonable and customary terms and conditions with respect to the Licensed
Product supplied to Daiichi Sankyo. The Quality Agreement will be based on
Nektar’s existing quality agreement with Nektar’s drug product contract
manufacturer for the Licensed Product.

7.Payments and Consideration.

7.1Initial License Fee.  In partial consideration of the licenses and other
rights granted by Nektar to Daiichi Sankyo under this Agreement, Daiichi Sankyo
shall pay Nektar, within [***] following the Effective Date, a payment of Twenty
Million U.S. Dollars ($20,000,000).  Such payment shall be non-creditable,
non-refundable (except as provided in Section 16.2(f)), and not subject to
set-off.

27/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

7.2Milestone Payments. 

(a)Milestone Payment Amount.  In partial consideration of the licenses and other
rights granted by Nektar to Daiichi Sankyo under this Agreement, and subject to
Section (b) below, Daiichi Sankyo shall pay Nektar upon the first achievement of
the applicable milestone event described in the table below; provided however,
[***].  Each of the milestone payments hereunder is non-creditable,
non-refundable and not subject to set-off.

 

Milestone Event

Milestone Payment

1.

First Commercial Sale of the Licensed Product in the Territory following receipt
of Conditional Marketing Authorization in the EMA Territory

$10,000,000

2.

First Commercial Sale of the Licensed Product in the Territory following receipt
of Final Marketing Authorization

$25,000,000

3.

First time the aggregate Net Sales for the Licensed Product in the Territory
equal or exceed Sixty Million Euros (€60,000,000) at any point during a given
Calendar Year

$25,000,000

 

(b)Reduction to Milestone Payment Number Two (2).  

(i)In the event that the Actual Labeled Indication is narrower than the Narrow
Labeled Indication, within [***] following the date of Nektar’s receipt of the
Final Marketing Authorization, representatives appointed by each of the Parties
shall meet and determine the Actual Labeled Indication Population and the Narrow
Labeled Indication Population.  In their determination of the number of patients
in each such population, the Parties shall make each determination as of the
date set forth in the definition of the population (i.e., the Actual Labeled
Indication Population shall each be determined [***], and the Narrow Labeled
Indication Population shall be determined [***].

(ii)In the event that the Parties mutually determine that the Actual Labeled
Indication Population is lower than the Narrow Labeled Indication Population,
then the amount of the milestone payment corresponding to milestone number two
(2) above shall be multiplied by a fraction, the numerator of which shall be the
Actual Labeled Indication Population and the denominator of which shall be the
Narrow Labeled Indication Population.  In the event that the Parties are unable
to agree on either of the Actual Labeled Indication Population or the Narrow
Labeled Indication Population within [***] following the date of Nektar’s
receipt of the Final Marketing Authorization, the population(s) on which the
Parties are unable to agree shall be independently determined by a third party
expert with significant experience and expertise in the oncology market in the
Territory (the “Arbitrator”), with the selection of such Arbitrator to be
mutually agreed by the Parties in good faith and [***].  Each of the Parties
shall submit its estimate of the contested population(s) to the Arbitrator
together with

28/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

a written statement of the rationale for the estimate within [***] after the
Arbitrator is appointed, and the Arbitrator shall issue a determination [***] of
the last submission of the Parties selecting the estimate submitted by the Party
which is closest to the Arbitrator’s independent estimate of the contested
population(s).  The Party’s estimate selected by the Arbitrator shall be binding
on both Parties for the determination of the amount to be paid for milestone
number two (2), and shall be final, unappealable and subject to enforcement by
any court of competent jurisdiction. 

7.3Royalties.

(a)Royalty.  In partial consideration of the licenses and other rights granted
by Nektar to Daiichi Sankyo under this Agreement, and in addition to the
foregoing payments, Daiichi Sankyo shall pay Nektar a royalty at the rate
described in the table below on Annual Net Sales of the Licensed Product in the
Territory by Daiichi Sankyo, its Affiliates and Sublicensees.  All royalty
payments under this Agreement are non-creditable, non-refundable and, except as
provided in Section 7.4(f), not subject to set-off.  For the avoidance of doubt,
royalties with respect to sales of Licensed Product shall be payable by Daiichi
Sankyo to Nektar irrespective of whether such Licensed Product is for the
Primary Indication or any other New Indication.

Applicable Territory

Royalty Rate on Annual Net Sales

EMA and Switzerland

20%

Turkey

15%

 

(b)Royalty Term.  Daiichi Sankyo’s obligation to pay royalties shall commence,
on a country-by-country basis, on the date of First Commercial Sale of the
Licensed Product in such country in the Territory, and shall expire, on a
country-by-country basis, on the latest to occur of (i) the [***] anniversary of
the First Commercial Sale of such Licensed Product in such country, or (ii) the
expiration date in such country of the last to expire of any Licensed Patent
that includes at least one Valid Claim Covering such Licensed Product, including
the Manufacture, use or sale thereof in such country.

(c)Reduction of Royalty.  In the event that, at the time a Licensed Product is
sold in a country in the Territory, there is no Valid Claim Covering such
Licensed Product, including the Manufacture, use or sale thereof in such
country, then for the purposes of calculating the royalties owed based on the
sale of such Licensed Product under Section (a) at that time, the royalties that
would otherwise be due and payable based on such sale shall be [***]; provided
however, that if a Generic Product is being Commercialized in such country, then
the royalties shall be [***].

(d)License Grants and Third Party Obligations.  In the event Daiichi Sankyo
reasonably determines that Intellectual Property Rights owned or Controlled by a
Third Party are required for Daiichi Sankyo to Commercialize a Licensed Product
in the Territory for which Daiichi Sankyo has exercised its Development rights
under Article 4, in each case in order not to infringe or misappropriate such
Intellectual Property Rights, Daiichi Sankyo shall have the right, but not the
obligation, to negotiate for and acquire such rights through a license or
otherwise, but shall have no right to deduct from royalty payments due under
this Section 7.3 or milestone

29/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

payments due under Section 7.2, any of the amounts paid (including milestone
payments, royalties or other license fees) by Daiichi Sankyo to such Third
Party.  Upon Daiichi Sankyo’s request, Nektar agrees to cooperate with Daiichi
Sankyo to acquire such rights. 

7.4Payment Terms.

(a)Manner of Payment.  All payments due hereunder shall be remitted in United
States Dollars by wire transfer to the Nektar Account.

(b)Milestone Payments. With respect to each of milestone numbers one (1), two
(2) and three (3), Daiichi Sankyo shall [***], and in all events no later than
[***] after such milestone is achieved, provide Nektar with written notice of
the achievement of such milestone.  Nektar shall then submit an invoice to
Daiichi Sankyo with respect to the corresponding milestone, provided that no
such invoice shall be submitted prior to the Effective Date.  Daiichi Sankyo
shall make the corresponding milestone payment within [***] after receipt of the
invoice from Nektar.

For the avoidance of doubt, (x) each milestone payment shall be payable only on
the first occurrence of the applicable milestone event; and (y) none of the
milestone payments shall be payable more than once, regardless of with respect
to which Agreed Indication such milestone event is achieved.

(c)Royalty Payments.  The royalties shall be calculated [***] as of the last day
of [***] respectively, for the [***] ending on that date.  Daiichi Sankyo shall
deliver a written report to Nektar within [***] after the end of each [***] that
shows, with respect to each country in the Territory, the total sales volumes
(total vials) and Net Sales (including calculation of the Net Sales in
reasonable detail as outlined in the definition of “Net Sales” in Section 1.1)
of the Licensed Product during such [***].  Following delivery of the written
report, Nektar shall invoice Daiichi Sankyo for the royalties due, and Daiichi
Sankyo shall make the corresponding royalty payment within [***] following
receipt of the invoice.

(d)Currency Exchange.  For the purpose of computing the Net Sales of a Licensed
Product sold in a currency other than U.S. Dollars or, solely with respect to
determining achievement of milestone number three (3), Euros, such currency
shall be converted from local currency to U.S. Dollars or Euros, as applicable,
by Daiichi Sankyo in accordance with the rates of exchange for the relevant
month for converting such other currency into U.S. Dollars or Euros as is quoted
by the Bundesbank on the last day of the month for which such conversion is to
be computed or other foreign conversion rate source to be mutually agreed upon
by the Parties.

(e)Taxes.  The payments made by one Party to the other Party under this
Agreement (including in the case of payments made to Nektar, the royalties and
milestone payments hereunder) or the Supply Agreement (“Payments”) shall not be
reduced on account of any taxes unless required by Applicable Law.  The Parties
agree to cooperate and produce on a timely basis any tax forms or reports
reasonably requested by the other Party in connection with any Payment.  Each
Party further agrees to provide reasonable cooperation to the other Party, at

30/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

the other Party’s expense, in connection with any official or unofficial tax
audit or contest relating to any Payment.  In addition, in the event any of the
Payments made by a Party to the other Party in connection with this Agreement or
the Supply Agreement become subject to withholding taxes under the Applicable
Laws of any jurisdiction, the paying Party shall deduct and withhold the amount
of such taxes for the account of the receiving Party to the extent required by
Applicable Law, such Payment to receiving Party shall be reduced by the amount
of taxes deducted and withheld, and the paying Party shall pay the amount of
such taxes to the proper Government Authority in a timely manner and promptly
transmit to the receiving Party an official tax certificate or other evidence of
such tax obligations, together with proof of payment from the relevant
Government Authority of all amounts deducted and withheld sufficient to enable
the receiving Party to claim such payment of taxes.  Each Party shall provide
the other Party with reasonable assistance to enable them to reduce or recover
such taxes as permitted by Applicable Law. 

(f)Set-off Rights.  In the event that Nektar, after receipt of written notice
from Daiichi Sankyo, fails to perform any of its indemnity obligations under
Section 12.2 of this Agreement and as a result of Nektar’s failure to perform
Daiichi Sankyo is required to incur out-of-pocket costs in order to obtain the
benefits it is entitled to under this Agreement, then if and to the extent
Nektar fails to pay, reimburse, or credit Daiichi Sankyo for such out-of-pocket
costs within [***] of a receipt of an invoice from Daiichi Sankyo, Daiichi
Sankyo may, at its election, with notice to Nektar of its election but without
demand, charge and set off such costs against amounts otherwise due from Daiichi
Sankyo pursuant to Section 7.3, and Nektar hereby authorizes all such charges
and set offs. If requested by Nektar in writing, prior to taking any such charge
or set off, Daiichi Sankyo agrees to designate at least [***] to meet with a
representative designated by Nektar at a mutually agreed time and place to
attempt to resolve the amount and payment of Daiichi Sankyo’s out-of-pocket
costs without the need for such charge or set off.

(g)Interest.  If Nektar does not receive payment of any sum due to it hereunder
on or before the due date therefor, interest shall thereafter accrue at the rate
of [***].

7.5Records Retention; Audit.

(a)For [***] following each [***] in which a Licensed Product is sold or a
payment obligation of Daiichi Sankyo under this Agreement accrues, Daiichi
Sankyo shall keep, or cause its Affiliates and Sublicensees to keep, complete
and accurate records or books of account in accordance with IFRS, to confirm
Daiichi Sankyo’s compliance with its financial obligations under this Agreement,
including the correctness of any payment made or required to be made by or on
behalf of Daiichi Sankyo, as applicable, and any report underlying such payment
(or lack thereof), pursuant to the terms of this Agreement.

(b)Upon the written request of Nektar, Daiichi Sankyo shall permit an
independent accounting firm of internationally recognized standing selected by
Nektar and reasonably acceptable to Daiichi Sankyo to inspect during regular
business hours and no more than [***] preceding the then-current Calendar Year,
all or any part of Daiichi Sankyo’s and its Affiliates’ and Sublicensees’
records and books necessary to confirm Daiichi Sankyo’s

31/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

compliance with its financial obligations under this Agreement, including the
correctness of any payment made or required to be made by or on behalf of
Daiichi Sankyo, as applicable, and any report underlying such payment (or lack
thereof), pursuant to the terms of this Agreement.  Daiichi Sankyo shall, and
shall cause its Affiliates and Sublicensees to, make their records available for
inspection by the accounting firm during regular business hours at such place or
places where such records are customarily kept, upon receipt of reasonable
advance notice from the accounting firm.  The records shall be reviewed solely
to verify the accuracy of any payment made or required to be made by or on
behalf of Daiichi Sankyo, as applicable, and any report underlying such payment
(or lack thereof), pursuant to the terms of this Agreement. 

(c)Prior to commencing any such audit, the accounting firm shall execute an
undertaking (or similar non-disclosure agreement) reasonably acceptable to
Daiichi Sankyo by which the accounting firm agrees to keep confidential all
information reviewed during the audit.  The accounting firm shall have the right
to disclose to Nektar only its conclusions regarding any payments owed under
this Agreement.  All information received and all information learned in the
course of any audit or inspection by Nektar shall constitute the Confidential
Information of Daiichi Sankyo for purposes of this Agreement.  Daiichi Sankyo
shall have the right to request a further determination by such accounting firm
as to matters which Daiichi Sankyo disputes within [***] following receipt of
such report.  Daiichi Sankyo will provide Nektar and the accounting firm with a
reasonably detailed statement of the grounds upon which it disputes any findings
in the audit report and the accounting firm shall undertake to complete such
further determination within [***] after the dispute notice is provided, which
determination shall be limited to the disputed matters.

(d)Nektar shall pay for such inspections, as well as its expenses associated
with enforcing its rights with respect to any payments hereunder.  If an
underpayment of more than [***] of the total payments due hereunder for the
applicable [***] is discovered, the fees and expenses charged of the accounting
firm shall be paid by Daiichi Sankyo.

7.6No Guarantee.  Nektar and Daiichi Sankyo acknowledge and agree that (a)
nothing in this Agreement shall be construed as representing an estimate or
projection of anticipated sales of any Licensed Product, and that (b) the
milestone events and Net Sales levels set forth in this Agreement or that have
otherwise been discussed by the Parties are merely intended to define the
milestone payments and royalty obligations to Nektar in the event such milestone
events or Net Sales levels are achieved.  Neither Party provides any
representation, warranty or guarantee that (i) the Manufacture of the Licensed
Product for the Agreed Indications will be successful, or even if successful
that it will be commercially viable; (ii) Development of the Licensed Product
will be successful; (iii) that Health Registration Approvals and Pricing
Approvals for the Licensed Product will be obtained; or (iv) that any other
particular results will be achieved with respect to Commercialization of the
Licensed Product hereunder.

8.Manufacturing and Supply.

8.1Manufacturing Responsibility.  Nektar shall have the sole right and
responsibility to Manufacture the Licensed Product for the Agreed Indications in
the Territory, subject to the terms of the separate Supply Agreement, in order
to supply Licensed Product to Daiichi Sankyo

32/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

to fulfill all of Daiichi Sankyo’s requirements for the Licensed Product in the
Territory.  Within [***] following the Effective Date, Daiichi Sankyo and Nektar
shall negotiate in good faith the terms of an agreement which will provide for
the exclusive supply by or on behalf of Nektar to Daiichi Sankyo of Manufactured
Licensed Product for use in the Territory on reasonable and customary terms and
conditions, including forecasting and ordering terms that are consistent with
Nektar’s obligations to its third party Manufacturing contractors and subject to
Section 8.2 (the “Supply Agreement”).  Nektar shall keep Daiichi Sankyo
reasonably apprised of its Manufacturing activities through Daiichi Sankyo’s
representatives on the JSC.  In addition, Nektar shall regularly and timely
report to Daiichi Sankyo any material developments or discoveries relating to
the Manufacture of the Licensed Product, including any material enhancements in
the Manufacture of the Licensed Product, whether made by or on behalf of Nektar
or otherwise of which Nektar becomes aware. 

8.2Supply Agreement Provisions – Manufacturing.  With respect to the Manufacture
of the Licensed Product, the Supply Agreement shall provide, inter alia, that:
(a) Daiichi Sankyo shall reimburse Nektar for its fully burdened manufacturing
costs in Manufacturing the Licensed Product for use in the Territory; (b) the
price at which the Licensed Product will be sold to Daiichi Sankyo shall be
adjusted [***] to reflect changes in Nektar’s fully burdened manufacturing cost
without profit markup; (c) for purposes of establishing the supply price for
Daiichi Sankyo, fully burdened manufacturing cost without profit markup shall
(i) be determined per unit of Licensed Product in accordance with GAAP and
consistent with the Manufacturing party’s internal accounting practices,
consistently applied, for the Manufacture of the Licensed Product, and (ii)
subject to audit by Daiichi Sankyo on terms substantially similar to those audit
rights exercised by Nektar under Section 7.5 of this Agreement; (d) in the event
of a shortage, and to the extent permitted under the agreements with Nektar’s
third party Manufacturing contractors, allocating to the Territory [***] of
Daiichi Sankyo’s requirements of the Licensed Product for the Territory before
any allocation outside the Territory; (e) payment terms of [***] following
delivery of the Licensed Product FCA Nektar’s designated third party
Manufacturer (Incoterms 2010); (f) for Licensed Product to be Packaged by
Daiichi Sankyo (if any), legal title and risk of loss will pass from Nektar to
Daiichi Sankyo upon delivery of the Licensed Product to the common carrier at
the facility of Nektar’s designated third party Manufacturer; (g) any necessary
import of the Licensed Product to the EU to be undertaken by Nektar (including
customs and analytics); (h) batch sizes shall be optimized to match with
reasonably expected overall order volumes to allow for reasonable order
frequencies and optimized shelf-life; and (i) reasonable safety stock
requirements of [***] (at Nektar’s expense, which shall be included in Nektar’s
fully burdened manufacturing costs).  [***]

8.3Supply Agreement Provisions – Packaging.  At the option of Daiichi Sankyo,
the Supply Agreement shall also provide for Nektar to be responsible for the
Packaging of the Licensed Product.  In the event that Daiichi Sankyo opts to
have Nektar be responsible for Packaging of the Licensed Product, then the
Supply Agreement shall provide, inter alia, that (a) in addition to the fully
burdened manufacturing costs of Manufacturing the Licensed Product, Daiichi
Sankyo shall also reimburse Nektar for its fully burdened manufacturing costs
without profit markup of Packaging the Licensed Product; (b) the [***]
adjustment to the price provided in Section 8.2 shall also include an adjustment
to reflect changes in Nektar’s costs of Packaging the Licensed Product; (c) for
purposes of establishing the supply price for Daiichi Sankyo for

33/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

Packaged Product, fully burdened manufacturing cost shall (i) be determined per
unit of Licensed Product in accordance with GAAP and consistent with the
Packaging party’s internal accounting practices, consistently applied, for the
Packaging of the Licensed Product, and (ii) subject to audit by Daiichi Sankyo
on terms substantially similar to those audit rights exercised by Nektar under
this Agreement; (d) payment terms of [***] following delivery of the Packaged
Licensed Product FCA Nektar’s designated third party Packager (Incoterms 2010);
(e) for Licensed Product to be Packaged by Nektar, legal title and risk of loss
will pass from Nektar to Daiichi Sankyo upon delivery of the Licensed Product to
the common carrier at the facility of Nektar’s designated third party Packager;
(f) any necessary import of Packaged Licensed Product to the EU to be undertaken
by Nektar (including customs and analytics); and (g) Packaging batch sizes shall
be optimized to match with reasonably expected overall order volumes to allow
for reasonable order frequencies and optimized shelf-life.  At the option of
Daiichi Sankyo, the Supply Agreement shall also provide for the right for
Daiichi Sankyo to transfer the responsibility for Packaging from Nektar to a
third party Packager of Daiichi Sankyo’s choice or to Daiichi Sankyo or its
Affiliate, on reasonable advance written notice to Nektar and reimbursement of
Nektar’s costs occasioned by the transfer.  For the avoidance of doubt,
Packaging for the purpose of Regulatory Documentation subject to Section 6.1
shall remain under the sole responsibility of Nektar. 

9.Ownership of Intellectual Property.

9.1Disclosure.  Each Party shall promptly disclose in writing to the other
Party, all Inventions arising from the joint or separate activities (including
any Inventions first made, conceived or first reduced to practice as a result of
such activities) of the Parties (including its employees, Affiliates,
sublicensees and agents) under or in connection with this Agreement.

9.2Ownership of Inventions.  Except as otherwise set forth in Sections 9.2(a) or
9.2(b), all Inventions made solely by employees, Affiliates, sublicensees or
agents of a Party under or in connection with this Agreement (each, a “Sole
Invention”) shall be the exclusive property of such Party.  Except as otherwise
set forth in Sections 9.2(a) or 9.2(b), if at least one employee, Affiliate,
sublicensee or agent of each of Nektar and Daiichi Sankyo jointly develop any
Invention under or in connection with this Agreement (each, a “Joint
Invention”), Nektar and Daiichi Sankyo shall each own an undivided one-half
(1/2) interest in and to such Joint Invention, and shall have the right to
freely exploit and grant licenses under any such Joint Invention and any Patent
claiming such Joint Invention without consent of or a duty of accounting to the
other Party.  For the avoidance of doubt, the determination as to whether an
Invention has been “solely” or “jointly” made shall be based upon whether
employees, Affiliates, sublicensees and agents of a Party would be or are
properly named as an inventor on a corresponding patent application under United
States inventorship laws.

(a)Nektar Core Technology Inventions.  Any and all rights, title and interest in
and to all Sole Inventions and Joint Inventions which fall within the scope of
Nektar Core Technology shall belong solely to Nektar (“Nektar Core Technology
Inventions”).  Daiichi Sankyo, on behalf of itself and its employees,
Affiliates, Sublicensees and agents, hereby agrees to and hereby does, without
additional consideration, transfer and assign to Nektar, all of its right, title
and interest in and to such Nektar Core Technology Inventions and all
intellectual

34/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

property rights therein including enforcement rights, and shall cause its
employees, Affiliates, Sublicensees and agents to so cooperate to vest rights,
title and interest therein to Nektar.  Nektar shall be responsible, at its sole
expense and discretion, and with the cooperation of Daiichi Sankyo, for the
filing, prosecution and maintenance of foreign and domestic patent applications
and patents covering such Nektar Core Technology Inventions. 

(b)Daiichi Sankyo Core Technology Inventions.  Any and all rights, title and
interest in and to all Sole Inventions and Joint Inventions which fall within
the scope of Daiichi Sankyo Core Technology shall belong solely to Daiichi
Sankyo (“Daiichi Sankyo Core Technology Inventions”).  Nektar, on behalf of
itself and its employees, Affiliates, sublicensees and agents, hereby agrees to
and hereby does, without additional consideration, assign to Daiichi Sankyo, all
of its right, title and interest in and to any Daiichi Sankyo Core Technology
Inventions and all intellectual property rights therein including enforcement
rights, and shall cause its employees, Affiliates, sublicensees and agents to so
cooperate to vest right, title and interest therein to Daiichi Sankyo.  Daiichi
Sankyo shall be responsible, at its sole expense and discretion, and with the
cooperation of Nektar if requested by Daiichi Sankyo, for the filing,
prosecution and maintenance of foreign and domestic patent applications and
patents covering such Daiichi Sankyo Core Technology Inventions.

9.3Assignments.  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
Development of the Licensed Product for Commercialization in the Territory or
who are otherwise participating in the Commercialization of the Licensed Product
in the Territory or who otherwise have access to any Confidential Information of
the other Party, rights to any and all Information that relates to a Licensed
Product in the Territory, 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, ownership and other rights granted to such Party by
the other Party under the terms of this Agreement.

9.4Trademarks.  Subject to the limitations and restrictions by the relevant
Health Authorities, Daiichi Sankyo will Commercialize the Licensed Product under
the Nektar Marks in connection with the Commercialization of the Licensed
Product in the Territory.  Should the Nektar Marks not be approved as the trade
name in an MA (or otherwise by a competent Governmental Authority in the event
the MA is silent with regard to the trade name), expire or become ineffective
for any reason in the Territory, Daiichi Sankyo may use a different trademark
from the Nektar Marks in the Territory, in which case the Parties will discuss
in good faith and mutually agree upon what different Trademark should be used in
connection with the Licensed Product in the Territory.  This Section 9.4 shall
apply accordingly to the so decided different Trademark as the Nektar
Marks.  The Licensed Product, including all labels (to the extent possible
taking into account space considerations) and labeling (including package
inserts), and all promotional materials will include, to the extent permitted by
Applicable Law, the Nektar House Marks.  Nektar shall own all right, title and
interest in and to the Nektar Marks and Nektar House Marks and shall retain the
sole and exclusive control and responsibility for the registration, filing,
maintenance, and enforcement of any Nektar Marks against any Trademark
challenge, misappropriation, or infringement suit, including instituting or
defending any claims or settling or otherwise resolving such challenge,
misappropriation, or Infringement Suit in the

35/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

Territory.  Daiichi Sankyo (a) shall adhere to any reasonable requests from
Nektar relating to Daiichi Sankyo’s use of such Nektar Marks and Nektar House
Marks, including those quality guidelines set forth on Exhibit D of this
Agreement, and shall not at any time do or authorize to be done any act or thing
that may impair the rights of Nektar therein; (b) shall not, except for the
licenses granted herein, at any time claim any right or interest in or to such
mark or the registrations or applications therefor; (c) shall, in each reference
to and use of the Nektar Marks and Nektar House Marks in any marketing material
related to the Licensed Product, identify Nektar as the owner of the Nektar
Marks and Nektar House Marks; and (d) shall not register or use any Trademark
confusingly similar to or identical with the Nektar Marks and Nektar House
Marks. 

10.Confidentiality and Non-Disclosure.

10.1Confidentiality Generally.  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.

10.2Permitted Disclosures.  Each Party may disclose Confidential Information of
the other Party 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 a Party or its respective Affiliates 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 as permitted under
this Agreement or any Ancillary Agreement; 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 13 through 15); provided however, that reasonable measures
shall be taken to assure confidential treatment of such information, to the
extent such protection is available; or

36/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

(d)otherwise required by law to be disclosed; provided however, that if 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. 

10.3Exclusions.  Notwithstanding the foregoing, Confidential 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 use or 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 shall not be deemed to
be within the public domain or in the possession of the Receiving Party merely
because the Confidential 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 shall not be considered in the public
domain or in the possession of the Receiving Party merely because individual
elements of such Confidential 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.

10.4Confidentiality 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 [***] to request redactions thereof prior
to making such filing or disclosure.  The Disclosing Party shall use reasonable
efforts to seek confidential treatment of any such proposed

37/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

redactions timely made, to the extent consistent with law, and use reasonable
efforts to procure confidential treatment of such proposed redactions pursuant
to any 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) bona fide potential investors, merger partners or acquirers and their
respective professional advisors, including, with respect to Nektar, its
potential licensees of the Licensed Product outside the Territory, who, in each
case ((a) and (b)) are subject to reasonable written confidentiality
restrictions (or if applicable ethical obligations of confidentiality), 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 evaluation
and negotiation of the prospective transaction and for no other purpose. 

10.5Use of Name.  Neither Party shall disclose or otherwise commercially use the
Trademark 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 written consent shall not be
unreasonably withheld or delayed), except for those disclosures for which
consent has previously been obtained or as provided under Section 9.4 and 10.4
through 10.6.  The restrictions imposed by this Section 10.5 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 10.  Further, the restrictions imposed on each Party
under this Section 10.5 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 contained in such
communications remains subject to this Article 10.

10.6Press Release.  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 Daiichi Sankyo 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.

38/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

10.7Publication. 

(a)Publishing Party.  Unless otherwise agreed to by the Parties, (i) Nektar will
have the sole right to submit a publication or arrange a public presentation
with respect to any Development of the Licensed Product conducted by or on
behalf of Nektar under this Agreement, and (ii) Daiichi Sankyo will have the
sole right to submit a publication or arrange a public presentation with respect
to any Development of the Licensed Product conducted by or on behalf of Daiichi
Sankyo under this Agreement.

(b)Review of Publications and Public Presentations.

(i)The JSC will establish a working group to coordinate publication and
presentation strategy and to review all publications and presentations with
respect to any Development of the Licensed Product submitted or arranged by or
on behalf of Nektar or Daiichi Sankyo under this Agreement.  Such working group
shall be comprised of such number of representatives from each of the Parties as
the JSC may direct from time to time, supervising and directing the activities
of such working group.  Neither Party shall be bound by any decisions or
directives of such working group, and each Party, acting as a Publishing Party,
shall have the right to exercise its rights in this Section 10.7(b) independent
of any decisions or directives of such working group.

(ii)If the Publishing Party desires to submit a publication or arrange a public
presentation that does not contain the Confidential Information of the other
Party, the Publishing Party will deliver to the other Party a copy of the
proposed written publication or presentation at least [***] prior to the initial
submission for publication or presentation to any Third Party.  The Publishing
Party agrees to give due consideration to any written comments made by the other
Party on the proposed publication or presentation.

(iii)If the Publishing Party desires to submit a publication or arrange a public
presentation that contains the Confidential Information of the other Party, the
Publishing Party will deliver to the other Party a copy of the proposed written
publication or presentation at least [***] prior to the initial submission for
publication or presentation to any Third Party.  The reviewing Party will have
the right (A) to propose modifications to the publication or presentation for
patent reasons or trade secret reasons or to remove Confidential Information of
the reviewing Party or its Affiliates or sublicensees, and the Publishing Party
will remove all Confidential Information of the other Party if requested by the
reviewing Party, and (B) to request a reasonable delay in publication or
presentation in order to protect patentable information.  If the reviewing Party
requests a delay, the Publishing Party will delay submission or presentation for
a period of [***] (or such shorter period as may be mutually agreed by the
Parties) to enable the non-publishing Party to file patent applications
protecting such Party’s rights in such information.  Without limiting the
foregoing, the Publishing Party agrees to give due consideration to any written
comments made by the other Party on the proposed publication or presentation.

(iv)With respect to any proposed publications or disclosures by investigators or
academic or non-profit collaborators, such materials will be subject to review

39/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

under this Section 10.7 to the extent that the Publishing Party has the right
and ability (after using Commercially Reasonable Efforts to obtain such right
and ability) to do so.  Further, neither Party will submit or publish any
article or other publication to or with any scientific journal or other
publisher that requires, as a condition of publication, that the submitting
Party agree to make available to the publisher or Third Parties any materials
which are the subject of the publication. 

11.Representations, Warranties and Covenants.

11.1Mutual Representations and Warranties.  Each Party represents and warrants
to the other Party 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 Party under this Agreement;

(c)it has taken all necessary action on its part required to authorize the
execution and delivery of this Agreement;

(d)it will conduct its activities under this Agreement in compliance with
Applicable Laws; and

(e)neither it nor its Affiliates (i) has been debarred or is subject to
debarment proceedings; or (ii) will use in any capacity, in connection with the
services to be performed under this Agreement, any Person who has been debarred
pursuant to Applicable Law, or who is the subject of a conviction thereof.  Each
Party agrees to inform the other Party in writing immediately if it or any
Person who is performing services hereunder is debarred under Applicable Law or
is the subject of a conviction thereof, 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.

11.2Representations and Warranties of Nektar.  Nektar represents and warrants to
Daiichi Sankyo as of the Effective Date as follows:

(a)Nektar is the sole and exclusive owner of all of the Licensed Patents and
Licensed Know-How in the Territory, and Nektar is entitled to grant the licenses
specified in Section 2.1 free and clear of all liens, claims, security interests
or other encumbrances of any kind (including prior license grants) that would
interfere, or the exercise of which would interfere, with Daiichi Sankyo’s
exercise of the licenses or rights granted hereunder;

(b)to the knowledge of Nektar, the Licensed Product Patents listed on Exhibit A
represent all Patents Controlled by Nektar or its Affiliates that are
particularly related to the Licensed Product in the Territory as of the
Effective Date (with the understanding that there are

40/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

other claims within the Licensed Patents that may cover NKTR-102 or aspects
thereof, e.g., cover Manufacturing aspects of NKTR-102); 

(c)to the knowledge of Nektar, (i) the issued patents in the Licensed Patents
are valid and enforceable, and (ii) there are no claims, challenges,
oppositions, interferences or other proceedings pending or threatened with
regard to any patent applications existing as of the Effective Date within the
Licensed Product Patents;

(d)there are no 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 Licensed Product Patents;

(e)[***], Nektar has not received written notice alleging the Development,
Manufacturing or Commercialization of the Licensed Product for the Primary
Indication in the Territory violates, misappropriates or infringes any Patent or
other Intellectual Property Right of any Third Party;

(f)[***], Nektar has obtained (i) from all individuals who are listed as
inventors in the Licensed Patents effective assignments of all ownership rights
of such individuals in such Licensed Patents and (ii) ownership interests in the
Licensed Know-How sufficient for Daiichi Sankyo to Commercialize a Licensed
Product in the Territory for which Daiichi Sankyo has exercised its Development
rights under Article 4, and in the case of each of (i) and (ii), either pursuant
to written agreement or by operation of law;

(g)all application, registration, maintenance and renewal fees in respect of the
Licensed Patents in the Territory as of the Effective Date have been paid and
all necessary documents and certificates have been filed with the relevant
agencies for the purpose of maintaining such Licensed Patents;

(h)the Licensed Patents and Licensed Know-How comprise all of the Patents,
Know-How and other Intellectual Property Rights used by Nektar, its Affiliates,
consultants and contractors in the Development and Manufacture of the Licensed
Product in the Territory prior to the Effective Date;

(i)Nektar has not committed any act, or omitted to commit any act, that may
cause the Licensed Patents to expire prematurely or be declared invalid or
unenforceable;

(j)Nektar has not initiated or been involved in any proceedings or Claims in
which it alleges that any Third Party is or was infringing or misappropriating
any Nektar Intellectual Property Rights licensed to Daiichi Sankyo under Section
2.1 in the Territory, nor have any such proceedings been threatened by Nektar,
nor does Nektar know of any valid basis for any such proceedings;

(k)to the knowledge of Nektar, no officer or employee of Nektar is subject to
any agreement with any other Third Party which requires such officer or employee
to assign any interest in any Nektar Intellectual Property Rights relating to
the Licensed Product or the Licensed Patents or Licensed Know-How in the
Territory to any Third Party; and

41/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

(l)Nektar has not granted any right to any Third Party or Government Authority
which would conflict with the rights granted to Daiichi Sankyo hereunder. 

11.3Compliance with Laws.

(a)Export Laws.  Notwithstanding anything to the contrary contained herein, all
obligations of Nektar and Daiichi Sankyo are subject to compliance with export
and import regulations and such other Applicable Laws in effect in such
jurisdictions or any other relevant country as may be applicable, and to
obtaining all necessary approvals required by the applicable Government
Authority of any relevant countries.  Nektar and Daiichi Sankyo shall cooperate
with each other and shall provide assistance to the other as reasonably
necessary to obtain any required approvals.

(b)Securities Laws.  Each of the Parties acknowledges that it is aware that the
securities laws of the United States and other countries prohibit any Person who
has material non-public information about a publicly listed company from
purchasing or selling securities of such company or from communicating such
information to any Person under circumstances in which it is reasonably
foreseeable that such Person is likely to purchase or sell such
securities.  Each Party agrees to comply with such securities laws and make its
Affiliates, licensees, sublicensees, distributors, employees, contractors and
agents aware of the existence of such securities laws and their need to comply
with such laws.

(c)Anti-Bribery and Anti-Corruption Compliance.

(i)Each Party agrees, on behalf of itself, its officers, directors and employees
and on behalf of its Affiliates, agents, representatives, distributors,
consultants and subcontractors hired in connection with the subject matter of
this Agreement (together with such Party, the “Representatives”) that for the
performance of its obligations hereunder:

(A)The Representatives shall not directly or indirectly pay, offer or promise to
pay, authorize the payment of any money or give, offer or promise to give, or
authorize the giving of anything else of value, to: (a) any Government Authority
official in order to influence official action; (b) any individual or entity
(whether or not a Government Authority official) (1) to influence such
individual or entity to act in breach of a duty of good faith, impartiality or
trust (as used in this subsection, “acting improperly”), (2) to reward such
individual or entity for acting improperly or (3) where such individual or
entity would be acting improperly by receiving the money or other thing of
value; (c) any individual or entity (whether or not a Government Authority
official) while knowing or having reason to know that all or any portion of the
money or other thing of value will be paid, offered, promised or given to, or
will otherwise benefit, a Government Authority official in order to influence
official action for or against either Party in connection with the matters that
are the subject of this Agreement; or (d) any individual or entity (whether or
not a Government Authority official) to reward that individual or entity for
acting improperly or to induce that individual or entity to act improperly.

42/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

(B)The Representatives shall not, directly or indirectly, solicit, receive or
agree to accept any payment of money or anything else of value in violation of
the Anti-Corruption Laws. 

(ii)The Representatives shall comply with the Anti-Corruption Laws and shall not
take any action that will, or would reasonably be expected to, cause either
Party or their respective Affiliates to be in violation of the Anti-Corruption
Laws.

(iii)Each Party, on behalf of itself and its other Representatives, represents
and warrants to the other Party that to the best of such Party’s and its
Affiliates’ knowledge, no Representative that will participate or support its
performance of its obligations hereunder has, directly or indirectly, (1) paid,
offered or promised to pay or authorized the payment of any money, (2) given,
offered or promised to give or authorized the giving of anything else of value
or (3) solicited, received or agreed to accept any payment of money or anything
else of value, in each case ((1), (2) and (3)), in violation of the
Anti-Corruption Laws during the three (3) years preceding the Effective Date.

(iv)Each Party shall [***] provide the other Party with written notice of the
following events: (1) upon becoming aware of any breach or violation by such
Party or its Representative of any representation, warranty or undertaking set
forth in Sections 11.3(c)(i) through 11.3(c)(iii); or (2) upon receiving a
formal notification that it is the target of a formal investigation by a
Government Authority for a material Anti-Corruption Law violation or upon
receipt of information from any of the Representatives connected with this
Agreement that any of them is the target of a formal investigation by a
Government Authority for a material Anti-Corruption Law violation.

(v)On the occurrence of any of the following events: (1) a Party becomes aware
that the other Party (or any other Representative) is in breach or violation of
any representation, warranty or undertaking in Sections 11.3(c)(i) and
11.3(c)(i) or of the Anti-Corruption Laws; or (2) notification is received under
Section 11.3(c)(iv) relating to any suspected or actual material Anti-Corruption
Law violation by a Party or its Representative, in either case ((1) or (2)), the
other Party shall have the right, in addition to any other rights or remedies
under this Agreement or to which such other Party may be entitled in law or
equity, to (x) take such steps as are reasonably necessary in order to avoid a
potential violation or continuing violation by such other Party or any of its
Affiliates of the Anti-Corruption Laws, including by requiring that the Party
agrees to such additional measures, representations, warranties, undertakings
and other provisions as such other Party believes in good faith are reasonably
necessary and (y) terminate any or all of the activities conducted by the Party
pursuant to this Agreement or this Agreement in its entirety, [***] in the event
that a Party reasonably concludes that there is no provision of this Agreement
available that would enable such Party or its Affiliates to avoid a potential
violation or continuing violation of applicable Anti-Corruption Laws.

(vi)Each Party shall be responsible for any breach of any representation,
warranty or undertaking in this Section 11.3(c) or of the Anti-Corruption Laws
by any of its Representatives.

43/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

(d)No Liens; Title.  In addition to the covenants made by Nektar elsewhere in
this Agreement, Nektar hereby covenants to Daiichi Sankyo that, from the
Effective Date until expiration or termination of this Agreement: 

(i)it shall not, and shall cause its Affiliates not to, incur or permit to
exist, with respect to any Licensed Patents or Licensed Know-How in the
Territory, any lien, encumbrance, charge, security interest, mortgage,
liability, assignment, grant of license or other binding obligation that is or
would be inconsistent with the licenses and other rights granted to Daiichi
Sankyo under this Agreement; and

(ii)where Nektar’s or its Affiliates’ ownership of all right, title and interest
to any of the Licensed Patents is based upon or depends on a sequence of
historical transfers of title to any such Licensed Patents (e.g. chain of title
to the applicable Licensed Patent) being free from defects, if at any time
during the Term there is a potential defect with the validity or effectiveness
in such transfers or other defect in such chain of title, then Nektar and its
Affiliates shall, at their expense, use Commercially Reasonable Efforts to make
any corrections and clarifications, including preparing any necessary Third
Party signatures and consents, as may be necessary, and filing such documents
with the applicable Government Authority, to correct such defect in chain of
title.

11.4DISCLAIMER OF WARRANTY.  EXCEPT FOR THE EXPRESS REPRESENTATIONS AND
WARRANTIES SET FORTH IN SECTIONS 11.1, 11.2, AND 11.3, NEITHER DAIICHI SANKYO
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 REPRESENTATIONS OR 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, THE NON-INFRINGEMENT OF ANY
INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES OR THE SUCCESSFUL EXPLOITATION OF
ANY LICENSED PRODUCT OR THAT ANY PARTICULAR RESULTS WILL BE ACHIEVED IN
CONNECTION WITH ACTIVITIES IN RESPECT THEREOF.

12.Indemnity.

12.1Indemnification by Daiichi Sankyo.  Subject to the other provisions of this
Article 12, Daiichi Sankyo shall defend Nektar, its Affiliates and its licensees
and each of their respective officers, directors, agents, representatives and
employees (collectively, “Nektar Parties”) from and against all charges,
allegations, civil, criminal or administrative claims, demands, complaints,
causes of action, proceedings or investigations of a Third Party (collectively,
“Third Party Claims”), and indemnify and hold harmless such Nektar Parties from
and against any and all Losses that result from any such Third Party Claims,
where and to the extent that such Third Party Claims are made or brought against
any Nektar Party by or on behalf of a Third Party, and solely to the extent such
Third Party Claim is based on, or arises out of: (a) Daiichi Sankyo’s, its
Affiliates’ or any of their respective Sublicensees’, distributors’,

44/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

subcontractors’ or other agents’ activities in connection with (i) Development
of the Licensed Product under this Agreement by or on behalf of Daiichi Sankyo;
and (ii) Commercialization of the Licensed Product Developed under this
Agreement by or on Daiichi Sankyo’s behalf; (b) the breach of any obligation,
covenant, warranty or representation made by Daiichi Sankyo under this Agreement
or any Ancillary Agreement; (c) any violation of Applicable Law by Daiichi
Sankyo, its Affiliates or any of their respective Sublicensees, distributors,
subcontractors or other agents in the course of activities under this Agreement
or any Ancillary Agreement; or (d) the gross negligence or willful misconduct of
any Daiichi Sankyo Party, their Sublicensees, subcontractors or other agents in
the course of their activities under this Agreement; provided however, that
Daiichi Sankyo shall not be required to defend, indemnify or hold harmless any
Nektar Party to the extent that such Third Party Claim or Loss is attributable
to any matter for which Nektar is obligated to indemnify a Daiichi Sankyo Party
pursuant to Section 12.2 below. 

12.2Indemnification by Nektar.  Subject to the other provisions of this Article
12, Nektar shall defend Daiichi Sankyo, its Affiliates and its Sublicensees and
each of their respective officers, directors, agents, representatives and
employees (collectively, “Daiichi Sankyo Parties”) from and against any Third
Party Claims, and indemnify and hold harmless such Daiichi Sankyo Parties from
and against any and all Losses that result from any such Third Party Claims,
where and to the extent that such Third Party Claims are made or brought against
any Daiichi Sankyo Party by or on behalf of a Third Party, and solely to the
extent such Third Party Claim is based on or arises out of: (a) claims that (i)
use of the Licensed Product in the BCBM Trial infringes the Intellectual
Property Rights of a Third Party; or (ii) Commercialization of the Licensed
Product as Developed by Nektar or its Affiliates for the Primary Indication in
the Territory infringes the Intellectual Property Rights of a Third Party; (b)
the breach of any obligation, covenant, warranty or representation made by
Nektar under this Agreement or any Ancillary Agreement; (c) any violation of
Applicable Law by Nektar, its Affiliates or any of their respective
subcontractors or other agents in the course of their activities under this
Agreement; (d) the Development of the Licensed Product for the Primary
Indication in the Territory by or on behalf of Nektar; (e) the Commercialization
of the Licensed Product outside the Territory; or (f) the gross negligence or
willful misconduct of any Nektar Party, their subcontractors or other agents in
the course of their activities under this Agreement; provided however, that
Nektar shall not be required to defend, indemnify or hold harmless any Daiichi
Sankyo Party to the extent that such Third Party Claim or Loss is attributable
to any matter for which Daiichi Sankyo is obligated to indemnify a Nektar Party
pursuant to Section 12.1 above.

12.3Indemnification Procedures.  A Person entitled to indemnification pursuant
to either Section 12.1 or Section 12.2 will hereinafter be referred to as an
“Indemnitee.”  A Party obligated to indemnify an Indemnitee hereunder will
hereinafter be referred to as an “Indemnitor.”  In the event a Nektar Indemnitee
or a Daiichi Sankyo Indemnitee is seeking indemnification under either Section
12.1 or Section 12.2, Nektar or Daiichi Sankyo, as applicable, will inform the
Indemnitor of a Third Party Claim (an “Indemnification Claim Notice”) [***]
after it receives notice of the Third Party Claim, it being understood and
agreed that the failure to give notice of a Third Party Claim as provided in
this Section 12.3 will not relieve the Indemnitor of its indemnification
obligation under this Agreement except and only to the extent that such
Indemnitor is actually and materially prejudiced as a result of such failure to
give notice.  Upon the written acknowledgement by the Indemnitor, within [***]
following

45/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

receipt of such Indemnification Claim Notice acknowledging that such Third Party
Claim is one with respect to which the Indemnitor is obligated to indemnify, the
Indemnitee will permit the Indemnitor to assume direction and control of the
defense of the Third Party Claim, and, at the Indemnitor’s expense, will
cooperate as reasonably requested in the defense of the Third Party Claim.  The
Indemnitee will have the right to retain its own counsel at its own
expense.  The Indemnitor may not settle such Third Party Claim, or otherwise
consent to an adverse judgment in such Third Party Claim without the
Indemnitee’s prior written consent, not to be unreasonably withheld, conditioned
or delayed; provided that the Indemnitor shall not require such consent with
respect to the settlement of any Third Party Claim under which the sole relief
provided is for monetary damages that are paid in full by the Indemnitor, which
would not materially diminish or limit or otherwise adversely affect the rights,
activities or financial interests of the Indemnitee or the Party to which that
Person relates, and which does not result in any finding or admission of fault
by the Indemnitee or the Party to which that Person relates.  If the Indemnitor
does not assume direction and control of the defense of the Third Party Claim,
the Indemnitee may defend and settle such Third Party Claim (including consent
to an adverse judgment in such Third Party Claim) without the Indemnitor’s prior
written consent. 

12.4LIMITATION OF LIABILITY.  EXCEPT IN CIRCUMSTANCES OF (A) GROSS NEGLIGENCE OR
WILLFUL MISCONDUCT BY A PARTY, (B) A BREACH OF ARTICLE 10 OR SECTION 2.4, (C)
SOLELY WITH RESPECT TO LOSS OF PROFITS BUT NOT WITH RESPECT TO ANY OTHER
SPECIAL, INDIRECT OR CONSEQUENTIAL DAMAGES, SECTION 2.5, OR (D) FOR THIRD PARTY
CLAIMS WHICH ARE SUBJECT TO INDEMNIFICATION UNDER THIS ARTICLE 12, IN NO EVENT
SHALL ANY PARTY OR ANY OF ITS RESPECTIVE AFFILIATES BE LIABLE UNDER THIS
AGREEMENT FOR SPECIAL, INDIRECT OR CONSEQUENTIAL DAMAGES, WHETHER IN CONTRACT,
WARRANTY, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, INCLUDING LOSS OF
PROFITS, SUFFERED BY DAIICHI SANKYO, NEKTAR OR ANY OF THEIR RESPECTIVE
AFFILIATES.

12.5Insurance.  Each Party shall, at its own expense, maintain comprehensive
general commercial liability insurance, including product liability insurance,
contractual liability, bodily injury, property damage and personal injury
coverage adequate to cover its obligations and liabilities under this Agreement
and the Ancillary Agreements, and which are consistent with normal business
practices of comparable companies with respect to similar obligations and
liabilities.  Such coverage shall be purchased for a minimum limit of
[***].  The Parties shall maintain such insurance for so long as this Agreement
or an Ancillary Agreement is in effect, and shall from time to time provide
copies of certificates of such insurance to each other upon request.  If the
insurance policy is written on a claims-made basis, then the coverage must be
kept in place for at least [***] after the termination of this Agreement.

13.Maintenance and Prosecution of Licensed Patents.

13.1Prosecution of Licensed Patents.

(a)Licensed Patents.  Nektar shall, at its own cost, have the right and the
obligation to prepare, file, prosecute (including the responsibility to conduct
and manage any

46/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

interferences, reissue proceedings, oppositions and re-examinations), and
maintain (collectively, “Prosecute” or “Prosecution”) the Licensed Patents. 

(b)Individual Patent Filings.  Without limiting Section 13.1(a), Nektar shall
have sole discretion and right to Prosecute Patents for Sole Inventions and
Joint Inventions contained within Nektar Core Technology Inventions, and Daiichi
Sankyo shall have the sole discretion and right to Prosecute Patents for Sole
Inventions and Joint Inventions contained within Daiichi Sankyo Core Technology
Inventions.

(c)Joint Patent Applications.  With respect to applications for Patents on Joint
Inventions that are neither Nektar Core Technology Inventions nor Daiichi Sankyo
Core Technology Inventions (the “Joint Patent Applications”), the Parties shall
determine which Party shall be responsible for Prosecuting Patents on behalf of
both Parties (the “Responsible Party”) based on a good faith determination of
the relative contributions of the Parties to the Joint Invention and the
relative interests of the Parties in the Joint Invention.  At least [***] prior
to the contemplated filing of such Joint Patent Application, the Responsible
Party shall submit a substantially completed draft of the Joint Patent
Application to the other Party for its approval, which shall not be unreasonably
withheld or delayed.  Except as set forth below, the Parties shall share equally
the costs of the Prosecution of all Joint Patent Applications.  If either Party
elects not to pay its portion of any shared costs for a Joint Patent Application
or Patent issuing therefrom, the other Party may proceed with such Joint Patent
Application in its own name and at its sole expense, in which case the Party
electing not to pay its share of costs hereby agrees to transfer and assign and
shall transfer and assign its entire right, title and interest in and to such
Joint Patent Application to the other Party and such Invention shall be treated
as a Sole Invention of the assignee for the purposes of Section 13.1(b).

(d)Further Actions.  Each Party shall cooperate with the other Party to execute
all documents and take all reasonable actions to effect the intent of this
Section 13.1.

13.2Patent Term Extensions.  [***].  If any such extension may only be sought by
a party holding the applicable Marketing Authorization within the Territory,
then following the transfer of such Marketing Authorization by Nektar to Daiichi
Sankyo, if requested by Nektar, and at Nektar’s expense, Daiichi Sankyo shall
apply to obtain such an extension at Nektar’s direction, in which case Daiichi
Sankyo agrees to cooperate with Nektar in the exercise of such authorization and
shall execute such documents and take such additional action as Nektar may
reasonably request in connection therewith.  [***]

14.Enforcement of Patents.

14.1Notice of Infringement.  If either Party believes that a Third Party is
infringing any of the Patents licensed to the other Party under this Agreement
in the Territory, or is requesting a license or other right under such Patents
in the Territory (“Third Party Infringing Activities”), such Party shall [***]
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.

47/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

14.2Control of Enforcement.  If any Third Party Infringing Activity infringes
any Licensed Patent, then Nektar shall have the sole right and subject to this
Section 14.2, the obligation, through counsel of its choosing, to take any
measures it deems appropriate to stop such Third Party Infringing Activity that
materially affects the Licensed Product in the Territory, including granting to
the infringing Third Party adequate rights and licenses under the Licensed
Patents necessary for continuing such activities; [***].  The Parties will
cooperate in good faith to determine the appropriate measures to stop any Third
Party Infringing Activity that infringes any jointly owned Joint Inventions. 

14.3Cooperation.  Upon reasonable request by the Party permitted to take legal
action against Third Party Infringing Activities under this Article 14 (the
“Enforcing Party”), 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.

14.4Recovery.  Any amounts recovered with respect to Third Party Infringing
Activities, whether by settlement or judgment, shall be used first to reimburse
the Parties for their reasonable costs and expenses in making such recovery
(which amounts shall be allocated pro rata if insufficient to cover the totality
of such expenses), with any remainder being paid to the Parties [***].

15.Potential Third Party Actions.

15.1Invalidity or Unenforceability Defenses or Actions.

(a)Notice.  If a Third Party asserts that any Patent licensed to the other Party
under this Agreement is invalid or unenforceable in the Territory, whether as a
defense or as a counterclaim in a legal 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 [***] give written notice to the other Party.  For the
avoidance of doubt, in no event shall any interferences, reissue proceedings,
oppositions and re-examinations be deemed an Invalidity Action, and the conduct
and management of any such matters shall be governed by the provisions of
Article 14.

(b)Control of Action.  [***].

15.2Third Party Litigation.  In the event of any actual or threatened suit
against Nektar or its Affiliates or licensees, or Daiichi Sankyo or its
Affiliates, Sublicensees or customers alleging that the Development,
Manufacturing or Commercialization of the Licensed Product in the Territory
infringes the Intellectual Property Rights of any Third Party (an “Infringement
Suit”), the Party first becoming aware of such Infringement Suit shall [***]
give written notice to the other Party.  [***]

15.3Cooperation.  Except to the extent restricted from doing so by Applicable
Law or contract, each Party will provide to the other Party, at other Party’s
expense, all reasonable assistance requested by other Party in connection with
any action, claim or suit under Section

48/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

15.1 or 15.2 solely to the extent necessary or reasonably useful to respond to
or defend against the applicable actions or claims. 

16.Term and Termination.

16.1Term.  The term of this Agreement shall take effect as of the Effective Date
and shall continue until (a) expiration, which shall occur automatically upon
the expiry of all obligations of Daiichi Sankyo to pay royalties with respect to
the Licensed Product in all countries in the Territory, or (b) earlier
terminated in accordance with this Article 16 (the “Term”).  [***] prior to
expiration of this Agreement, the Parties will meet and negotiate in good faith
about new supply terms for the Manufacture of the Licensed Product in the
Territory following such expiration.  If the Parties are unable to agree on new
supply terms, then Nektar shall have no obligation to continue to Manufacture
(and, if applicable, Package) Licensed Product following such expiration.  

16.2Termination by Either Party.

(a)Termination for Material Breach.  If either Party (the “Breaching Party”) is
in material breach of this Agreement, in addition to any other right or remedy
the other Party (the “Complaining Party”) may have, the Complaining Party may
terminate this Agreement by providing the Breaching Party notice specifying the
breach and an opportunity to cure such breach in accordance with this Section
16.2(a) (the “Termination Notice”).  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 [***] as the
Breaching Party is thereafter diligently continuing such good faith actions to
cure the breach as soon as possible) (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).

(b)Termination Upon Bankruptcy.  A Party shall be deemed a “Debtor” under this
Agreement if, at any time during which a Party has rights to the other Party’s
Intellectual Property Rights under this Agreement, (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 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.  All rights and licenses granted under
or pursuant to this Agreement by Nektar are, and shall be deemed to be, for
purposes of Section 365(n) of the Bankruptcy Code, licenses of rights to
“intellectual property” as defined under Section 101 of the Bankruptcy
Code.  The

49/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

Parties agree that the Parties, as licensees of such rights under this
Agreement, shall retain and may fully exercise all of their rights and elections
under the Bankruptcy Code.  If a Party is the Debtor, then the other Party shall
be entitled to a complete duplicate of (or complete access to, as appropriate)
any such intellectual property necessary to enjoy the benefits of this Agreement
and all embodiments of such intellectual property, and if not already in the
non-Debtor Party’s possession, such shall be promptly delivered to such Party
upon its written request therefor and in the case where Nektar is the Debtor,
the same shall not affect Daiichi Sankyo’s payment or other obligations to
Nektar hereunder. 

(c)Termination Prior to Receipt of Final Marketing Authorization by Daiichi
Sankyo.  Daiichi Sankyo may terminate this Agreement in its entirety pursuant to
this Section 16.2(c) prior to receipt of Final Marketing Authorization for the
Licensed Product, if (i) the BCBM Trial is completed and is determined by the
Health Authority for the EMA Territory to be insufficient to support a grant of
Final Marketing Authorization; (ii) (A) the Conditional Marketing Authorization
is not granted in the EMA Territory on or prior to [***], or (B) prior to [***]
it becomes apparent that it is impossible for the Conditional Marketing
Authorization to be granted in the EMA Territory on or prior to [***]; (iii) the
BCBM Trial is stopped after [***] due to a bona fide material safety issue or a
finding of lack of efficacy regarding the Licensed Product; or (iv) the EMA
requires any changes to the Anticipated Labeled Indication and such changes
result in the Anticipated Labeled Indication being narrower than the Narrow
Labeled Indication.

(d)Termination Prior to Receipt of Final Marketing Authorization by Nektar.
Nektar may terminate this Agreement in its entirety pursuant to this Section
16.2(d) prior to receipt of Final Marketing Authorization for the Licensed
Product, if (i) the BCBM Trial is completed and is determined by the Health
Authority for the EMA Territory to be insufficient to support a grant of Final
Marketing Authorization; (ii) the Conditional Marketing Authorization is not
granted in the EMA Territory on or prior to [***]; (iii) the BCBM Trial is
stopped after [***] due to a bona fide material safety issue or a finding of
lack of efficacy regarding the Licensed Product; or (iv) the EMA requires any
changes to the Anticipated Labeled Indication and such changes result in a
material increase in the costs and expenses of the BCBM Trial and Daiichi Sankyo
has, within [***] from having been notified by Nektar about the expected amount
of the increase, failed to offer to Nektar in writing to reimburse it for the
additional costs and expenses [***].  

(e)Notice period. In order to terminate this Agreement pursuant to Section
16.2(c) and 16.2(d), the Party electing to terminate this Agreement shall
provide the other Party with written notice of its election to terminate not
later than [***] following the occurrence of the event giving rise to the right
to so terminate this Agreement, such termination to be effective [***] following
the date upon which the terminating Party delivers such written notice.

(f)Refund upon termination. If Daiichi Sankyo terminates this Agreement pursuant
to clauses (ii) or (iv) of Section 16.2(c), or if Nektar terminates this
Agreement pursuant to clause (iv) of Section 16.2(d), then, as Daiichi Sankyo’s
sole and exclusive remedy, Nektar shall issue to Daiichi Sankyo a refund in an
amount equal to twelve million five hundred thousand U.S. Dollars ($12,500,000)
within [***] of the effective date of such termination.

50/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

(g)Termination by Nektar Related to Post MA Approval Obligations. In the event
that any post-approval commitments or obligations imposed by the Health
Authority for either the EMA Territory or Switzerland which are the
responsibility of Nektar pursuant to Section 4.6 would require Nektar to conduct
a clinical trial of the Licensed Product in addition to the BCBM Trial, then (A)
if the applicable commitment or obligation is imposed by the Health Authority
for the EMA Territory, Nektar may terminate this Agreement in its entirety by
providing Daiichi Sankyo [***] prior written notice, such notice to be delivered
to Daiichi Sankyo not later than [***] from Nektar’s receipt of the written
imposition of the commitment or obligation from the Health Authority for the EMA
Territory;  and (B) if the applicable commitment or obligation is imposed by the
Health Authority for Switzerland, Nektar may terminate this Agreement solely as
it relates to Switzerland by providing Daiichi Sankyo [***] prior written
notice, such notice to be delivered to Daiichi Sankyo not later than [***] from
Nektar’s receipt of the written imposition of the commitment or obligation from
the Health Authority for Switzerland.  In the event that within [***] of Daiichi
Sankyo’s receipt of a termination notice from Nektar pursuant to Section
16.2(g)(A) or (B) Daiichi Sankyo agrees in writing to reimburse Nektar’s
out-of-pocket costs and expenses of fulfilling the commitment or obligation
giving rise to the Nektar termination notice [***], then Nektar shall withdraw
its termination notice and perform the commitment or obligation.   

16.3Termination by Daiichi Sankyo.  Daiichi Sankyo may terminate this Agreement
in its entirety at any time following receipt of Final Marketing Authorization
for the Licensed Product subject to providing Nektar [***] prior written notice.

16.4Termination by Nektar.  If Daiichi Sankyo, any of its Affiliates or any of
its Sublicensees makes any request for, or filing or declaration of, or
commences or maintains any action involving, or otherwise directly or indirectly
pursues, any interference, opposition, challenge as to ownership, assertion of
invalidity or unenforceability, unpatentability, revocation or reexamination
relating to any Licensed Patents, or based on any of the foregoing, challenges
or withholds the payment of any royalty under this Agreement in any lawsuit or
any other civil or administrative proceeding, or in connection with making of
any claim or counterclaim, before any court, tribunal, agency or governmental
entity anywhere in the world (“Licensed Patent Action”), or otherwise assists
any Third Party in connection with any Licensed Patent Action, then Nektar shall
have the right, but not the obligation, to terminate this Agreement upon
providing written notice of such termination to Daiichi Sankyo [***].

16.5Rights and Obligations Following Termination.  If this Agreement is
terminated, all rights and licenses granted to Daiichi Sankyo under this
Agreement shall terminate and revert exclusively to Nektar and the consequences
set forth in this Section 16.5 shall apply on and after the effective date of
the termination of this Agreement.

(a)Continuation of Right to Sell and Distribute.  Upon termination of this
Agreement with respect to any Licensed Product Manufactured prior to the
effective date of termination and supplied to Daiichi Sankyo, Daiichi Sankyo,
its Affiliates and Sublicensees shall have the ongoing right (including after
the date of termination) to sell and distribute such Licensed Product in
accordance with this Agreement, provided that, until such Licensed Product

51/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

has been sold, Daiichi Sankyo’s payment and record keeping obligations under
Article 7 shall continue to apply. 

(b)Return of Confidential Information.  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 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 and which remains subject to continuing compliance with the non-use and
non-disclosure obligations set forth in Article 10).

(c)Access to Data; Right of Reference.  In addition to Nektar’s rights elsewhere
in this Agreement, Daiichi Sankyo and its Affiliates shall disclose and transfer
to Nektar (i) copies of all Information of Daiichi Sankyo and its Affiliates and
Sublicensees relating to the Licensed Product, and automatically grant to
Nektar, effective as of the effective date of any such termination of this
Agreement, an exclusive (even as to Daiichi Sankyo) right to use such
Information for all purposes related to the Licensed Product; and (ii) a right
of reference (which right is fully transferable to other parties, with Daiichi
Sankyo agreeing to provide any needed letters acknowledging such right of
reference as needed by any transferee) to all Regulatory Documentation that
Daiichi Sankyo and its Affiliates Control, to the extent necessary for Nektar to
Develop, Manufacture and Commercialize the Licensed Product.

(d)License to Information and Daiichi Sankyo Patents.  

(i)Daiichi Sankyo shall grant to Nektar, effective as of the effective date of
any such termination of this Agreement, a perpetual, irrevocable,
sublicenseable, non-exclusive license under any Information generated by Daiichi
Sankyo, its Affiliates or Sublicensees under this Agreement to Develop,
Manufacture and Commercialize the Licensed Product. If Nektar has not previously
compensated Daiichi Sankyo for the use of such Information pursuant to Section
4.2, then Nektar and Daiichi Sankyo shall mutually negotiate in good faith the
reasonable compensation to be paid by Nektar to Daiichi Sankyo for the license
granted in this Section 16.5(d)(i), provided that no such compensation shall be
payable by Nektar if the termination of this Agreement was due to breach by
Daiichi Sankyo pursuant to Section 16.2(a).  

(ii) Upon request of Nektar, the Parties shall negotiate in good faith the grant
by Daiichi Sankyo to Nektar of a license under any and all Patents Controlled by
Daiichi Sankyo or its Affiliates or Sublicensees, covering inventions,
technology or other Information necessary to Develop, Manufacture and
Commercialize the Licensed Product with respect to all countries in the
Territory.

(e)Regulatory Documentation.  Daiichi Sankyo shall, to the extent technically
possible and if not prohibited under Applicable Law, promptly transfer and
assign to Nektar any and all right, title, and interest in any and all Health
Registration Approvals and Pricing Approvals, all applications therefor, and all
Regulatory Documentation assigned by Nektar to Daiichi Sankyo under the terms of
this Agreement, including the Final Marketing Authorization and any other
Marketing Authorization.  With respect to such transferred Health

52/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

Registration Approvals, Pricing Approvals and Regulatory Documentation, Daiichi
Sankyo will submit to the applicable Health Authorities, within [***] after the
effective date of such termination, a letter (with a copy to Nektar) or other
communication required by the applicable Health Authorities, notifying such
Health Authorities of such transfer.  Prior to submitting any such letters,
Daiichi Sankyo shall make available any such letter to Nektar at least [***]
prior to its submission, and shall make such changes as Nektar may reasonably
request prior to the submission of such letter to the applicable Health
Authority, each such letter or other communication to be reasonably satisfactory
to Nektar in form and content. 

(f)Termination of Manufacturing and Packaging Obligations of Nektar. Termination
of this Agreement shall also terminate Nektar’s obligation to Manufacture (and,
if applicable, Package) Licensed Product.

16.6Post-termination Indemnification.  Nektar shall indemnify and hold Daiichi
Sankyo harmless from and against any and all Losses that result from any Third
Party Claims brought against Daiichi Sankyo to the extent based on the
Development, Manufacture, and Commercialization of the Licensed Product
conducted by or on behalf of Nektar worldwide from and after the effective date
of such termination.

16.7Remedies.  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.

16.8Accrued Rights; Surviving Obligations.

(a)Accrued Rights.  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).

(b)Survival Following Expiration or Termination.  If this Agreement expires or
terminates, each Party’s rights and obligations under Sections 2.6, 4.4 (for a
period of [***] following the termination of this Agreement), 7.5 (for the
applicable period of time provided therein), 7.6, 9.2, 9.3, and Articles 10 (for
a period of [***] following the termination of this Agreement), 11, 12, 16, 18
and 19 shall survive the expiration or termination of this Agreement.

17.Informal Dispute Resolution.

If a dispute, other than a dispute under Article 3 of this Agreement or a Legal
Matter, arises between the Parties in connection with or relating to this
Agreement or any document or instrument delivered in connection herewith, 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.

53/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

18.Governing Law, Jurisdiction, Venue and Service. 

18.1Governing 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.

18.2Jurisdiction.  Subject to Section 19.9, the Parties hereby irrevocably and
unconditionally consent to the exclusive jurisdiction of the U.S. District Court
for the Southern District of New York (or if such court does not have subject
matter jurisdiction, the state courts of the State of New York located in New
York County) for any action, suit or proceeding (other than appeals therefrom)
arising out of or relating to this Agreement or any Ancillary 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.

18.3Venue.  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
set forth in Section 18.2, 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.

18.4[Intentionally left blank.]

18.5Change of Control.  In the event of a Change of Control in Nektar involving
a Third Party who is a Competitor as of the date of such Change of Control:

(a)Daiichi Sankyo shall have the right to require that Nektar, the Competitor
with whom such Change of Control is effected, and each of their respective
Affiliates, adopt procedures reasonably calculated to limit the use by or the
dissemination of Sensitive Information to, only those Persons employed by or
under contract with Nektar or its Affiliates, in each case having a need to know
such Sensitive Information in order for Nektar to perform its obligations and
exercise its rights under this Agreement.

(b)For the purpose of this Section 18.5, “Sensitive Information” means all
Confidential Information of Daiichi Sankyo or its Affiliates disclosed to
Nektar, its Affiliates or Persons employed by or under contract with Nektar or
its Affiliates including Confidential Information arising from Daiichi Sankyo’s
Commercialization of the Licensed Product hereunder.

18.6Assignment.  Neither Party will assign this Agreement or any rights or
obligations hereunder without the prior written consent of the other Party,
which consent will not be unreasonably withheld or delayed, except as follows:
(a) Nektar may assign its rights and obligations under this Agreement by way of
sale of Nektar or the sale of all or substantially all of the business of Nektar
to which this Agreement relates, through merger, sale of assets or sale of

54/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

stock or ownership interest; (b) either Party may assign its rights and
obligations under this Agreement to an Affiliate of such Party; and (c) Nektar
may assign any or all of its rights under Article 7 in connection with a
financing transaction, and Daiichi Sankyo agrees that, upon written notice from
Nektar (or any direct or indirect permitted assignee contemplated by this
Section 18.6), Daiichi Sankyo shall deliver any future payments, together with
any reports or statements contemplated under Article 7, in accordance with the
directions in such written notice.  Nektar will timely notify Daiichi Sankyo of
any assignment or transfer under the provisions of clause (a) of this Section
18.6.  The assigning Party will remain liable for all of its rights and
obligations under this Agreement, including those in effect after the applicable
assignment.  This Agreement will be binding upon the successors and permitted
assigns of the Parties, and the name of a Party appearing herein will be deemed
to include the names of such Party’s successors and permitted assigns to the
extent necessary to carry out the intent of this Agreement.  Any assignment not
in accordance with this Section 18.6 will be void. 

19.Miscellaneous.

19.1Force 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 [***] 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 19.1(a), the Force Majeure Party shall not be liable for
delay in performance or for non-performance of its obligations under this
Agreement or any Ancillary Agreement, in whole or in part, nor shall the other
Party have the right to terminate this Agreement (or the applicable Ancillary
Agreement), except as otherwise provided in this Agreement (or the applicable
Ancillary 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 Commercially Reasonable Efforts 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.

19.2Severability.  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

55/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

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. 

19.3Notices.

(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 by internationally recognized overnight delivery
service, addressed to the Parties at their respective addresses specified in
Section 19.3(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
19.3.  Such notice shall be deemed to have been given as of the date delivered
by hand or on the second Business Day (at the place of delivery) after deposit
with an internationally recognized overnight delivery service.  This Section
19.3 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.

For:Daiichi Sankyo Europe GmbH
Address: Zielstattstr 48, 81379 Munich, Germany
For the attention of:Affiliate and Brand Management

With a copy to:Legal Department
Address:Zielstattstr 48, 81379 Munich, Germany

For:Nektar Therapeutics
Address:455 Mission Bay Boulevard South
San Francisco, California, USA  94158
For the attention of:General Counsel

With a copy to:Hogan Lovells US LLP
Address: 875 Third Avenue
New York, NY  10022
For the attention of:Adam H. Golden, Esq.

19.4Relationship 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

56/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

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. 

19.5Entire Agreement.  This Agreement, together with the Ancillary Agreements,
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.  The Parties shall (or shall cause their applicable Affiliate to)
terminate the Confidentiality Agreements effective as of the Effective Date and
to agree that any surviving obligations thereunder are superseded by this
Agreement; provided that each of the Parties acknowledges and agrees that such
termination of the Confidentiality Agreements shall not relieve the Parties for
obligations under such agreement for breaches thereof which occurred prior to
the Effective Date.  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
or the Ancillary Agreements.  All 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 Exhibits and
this Agreement, the terms of this Agreement shall govern.

19.6English 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.

19.7Amendment.  Any amendment, modification or supplement of this Agreement must
be in writing and signed by authorized representatives of both Parties.

19.8Waiver.  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.

19.9Equitable Relief.  Notwithstanding anything in this Agreement to the
contrary:

(a)Each Party acknowledges and agrees that the restrictions set forth in Section
2.6 and Article 10 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 2.6 or Article 10 will
result in irreparable injury to the other Party for which there may be no
adequate remedy at law.

(b)In the event of a breach or threatened breach of any provision of Section
2.4, Section 2.6 or Article 10 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, 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.

57/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

(c)Nothing in this Section 19.9 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. 

19.10Further 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.

19.11Expenses.  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.

19.12Counterparts.  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 Page Follows]

 

58/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

***Text Omitted and Filed Separately with the Securities and Exchange
Commission. Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

THIS AGREEMENT IS EXECUTED by the authorized representatives of the Parties as
of the date first written above.

DAIICHI SANKYO EUROPE GmbH

 

NEKTAR THERAPEUTICS

 

/s/ Jan Van Ruymbeke

 

 

/s/ Howard W. Robin

 

 

 

Signature

 

Signature

Name:

Dr. Jan Van Ruymbeke

 

Name:

Howard W. Robin

Title:

Managing Director, CEO

 

Title:

President & CEO

 

/s/ Martin Hesse

 

 

Signature

 

 

 

Name:

Martin Hesse

 

 

 

Title:

Managing Director, CFO

 

 

 

 

59/66

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

Exhibit A

Licensed Product Patents

[***]

60/66

 

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

Exhibit B-1

Nektar Marks

ONZEALD

 

 

61/66

 

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

Exhibit B-2

Nektar House Marks

[gbljdgkle2s3000001.jpg]

NEKTAR

 

 

  62/66

 

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

Exhibit C

Summary of BCBM Protocol

[***]

 

  63/66

 

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016

--------------------------------------------------------------------------------

Exhibit D

Trademark Quality Guidelines

[gbljdgkle2s3000002.jpg]

 

In the event of a corporate-wide update to Nektar's logo, the Trademark Quality
Guidelines (this Exhibit D) to be updated accordingly with sufficient notice to
Daiichi Sankyo.  

 

  66/66

 

Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016