Collaboration Agreement

You are currently viewing:

This Collaboration Agreement involves

AMGEN INC | Daiichi Sankyo Company, Limited

. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here.

Title: Collaboration Agreement
Governing Law: California Date: 11/9/2007
Industry: Biotechnology and Drugs Sector: Healthcare

Collaboration Agreement, Parties: amgen inc , daiichi sankyo company limited

Exhibit 10.80

Execution Copy

Collaboration Agreement

By and Between

Amgen Inc.

and

Daiichi Sankyo Company, Limited

Dated

July 11, 2007

CONFIDENTIAL

Amgen Contract #200710717

Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.

Table of Contents


1. DEFINITIONS		7

2. COLLABORATION SCOPE AND GOVERNANCE		14
2.1 Conduct of the Collaboration		14
2.2 Ex-Territory Activities		14
2.3 Activities in Competition with the Collaboration		14
2.4 Post-Effective Date Affiliates		14
2.5 Termination or Divesture		15
2.6 Governance		15
2.7 Membership		15
2.8 Replacement of Members		16
2.9 Input from other Personnel		16
2.10 No Authority to Amend or Modify		16
2.11 Development Committee		16
2.11.1 Meetings		16
2.11.2 Reporting		16
2.11.3 Development Plans		17
2.11.4 Decision Making		17
2.12 Commercialization Committee		17
2.12.1 Meetings		17
2.12.2 Reporting		18
2.12.3 Commercialization Plans		18
2.12 4 Decision Making		18

3. GRANT OF LICENSE		18
3.1 Licensed Amgen Patents		18
3.2 Licensed Amgen Know-How		19
3.3 Licensed Collaborator Patents		19
3.4 Licensed Collaborator Know-How		19
3.5 Collaborator Sublicensing		20
3.6 Provision of Know-How		20
3.7 Trademarks		20
3.7.1 Grant to Collaborator		20
3.7.2 Grant to Amgen		21
3.8 Trademark Quality Standards		21
3.9 Retained Rights and Limitations		22

4. DEVELOPMENT AND REGULATORY APPROVAL		22
4.1 Responsibility for Development in Collaborator Indications		22
4.2 Preclinical Development in Collaborator Indications		22
4.3 [*]		23

Page 2 of 65


4.4 Development in Combination or Outside Territory		23
4.5 Responsibility for Development in Amgen Additional Indications		23
4.6 Development Outside the Territory		24
4.7 Global Development		24
4.8 Sharing of Regulatory Filings		24
4.9 Clinical Supply		25
4.10 Quality Agreement		25
4.11 Transfer of Regulatory Filing		25
4.12 Transfer of Regulatory Matters		25
4.13 Safety Agreement		25
4.14 Adverse Event Reporting		25
4.15 Communications		26
4.15.1 Collaborator Responsibility		26
4.15.2 AmgenResponsibility		26
4.15.3 Amgen Cooperation – Manufacturing Information		27
4.16 Recalls		28
4.16.1 Collaborator Right		28
4.16.2 Amgen Right		28
4.17 Cooperation Generally		28
4.18 Transition in Oncology Development		28

5. COMMERCIALIZATION		29
5.1 Operational Control in Collaborator Indications		29
5.2 Amgen Co-Promotion Right		29
5.3 Operational Control in Amgen Additional Indications		30
5.4 Commercialization Outside the Territory		30
5.5 Compliance with Laws, Regulations and Guidelines		30
5.6 Cooperation Generally		30

6. COLLABORATOR AND AMGEN ADDITIONAL INDICATIONS		31
6.1 Reasonably Diligent Efforts		31
6.2 Additional Indications		31
6.2.1 Amgen Developed Indications		31
6.2.2 Collaborator Proposed Indications		31

7. MANUFACTURE AND SUPPLY		31
7.1 Manufacturing Rights		31
7.2 Supply Agreement		31
7.3 Responsibility for Regulatory Filings with Respect to Manufacturing		32

8. PAYMENT		32
8.1 License Fee		32
8.1.1 License Fee		32
8.1.2 Milestone Payments		32
8.2 License Payments by Amgen		32

Page 3 of 65


8.2.1 License Fee		32
8.2.2 Milestone Payments		33
8.2.3 Maintenance Payments		33
8.2.4 Payments Survive		33
8.3 Royalty Payments		34
8.3.1 Collaborator Payments to Amgen		34
8.3.2 Calculation of Royalty Tiers		34
8.3.3 Amgen Payments to Collaborator		34
8.3.4 No Royalty on Amgen Sales Outside Territory		34
8.4 Appropriate Measure of Value		34
8.5 Calculation of Net Sales		34
8.5.1 Free Products		34
8.5.2 Bundled Products		34
8.6 Reports		35
8.7 No Wrongful Reductions		35
8.8 Development Cost Sharing		35
8.8.1 Amounts		35
8.8.2 Maximum Payments		35
8.8.3 Reports		36
8.8.4 Payments		36
8.8.5 Example		36
8.9 No Other Compensation		36
8.10 Payment Method		36
8.11 Change in Accounting Periods		37
8.12 Audits		37
8.13 Blocked Currency		37
8.14 Taxes		38
8.15 Withholding		38
8.16 VAT		38
8.17 Late Payment		38
8.18 Third Party Royalties		38

9. SETTLEMENT OF PATENT DISPUTES		38
9.1 Settlement		38

10. INTELLECTUAL PROPERTY		39
10.1 Ownership		39
10.2 Transition and Cooperation		39
10.2.1 Transition		39
10.2.2 Cooperation		39
10.3 Prosecution and Maintenance		40
10.3.1 In Territory		40
10.3.1.1 Collaborator [*] Prosecution		40
10.3.1.2 Amgen [*] Prosecution		40
10.3.2 Outside Territory		40

Page 4 of 65


10.4 Defense and Settlement of Third Party Claims		40
10.5 Enforcement		41
10.5.1 In Territory		41
10.5.1.1 Collaborator [*] Enforcement		41
10.5.1.2 Amgen [*] Enforcement		41
10.5.2 Outside Territory		41
10.6 Allocation of Recoveries		41
10.7 Patent Term Extensions		41
10.8 Employee Agreements		42
10.9 Patent Marking		42

11. CONFIDENTIALITY AND PUBLICATIONS		42
11.1 Confidentiality; Exceptions		42
11.2 Authorized Disclosure		43
11.3 Terms and Conditions Confidential		43
11.4 Prior Agreement		44
11.5 Publications		44
11.5.1 Primary Right		44
11.5.2 Other Publications		44
11.5.3 Oversight and Review		44
11.6 Attorney Client Privilege		45

12. REPRESENTATIONS, WARRANTIES AND COVENANTS		45
12.1 Mutual Representations, Warranties and Covenants		45
12.2 Amgen Additional Representations and Warranties		46
12.3 Disclaimer of Warranties		46

13. LIMITATIONS OF LIABILITY; INSURANCE		47
13.1 Limitations of Liability		47
13.2 Insurance		47

14. INDEMNIFICATION		47
14.1 Indemnity		47
14.2 Claim for Indemnification		48

15. TERM AND TERMINATION		48
15.1 Term		48
15.2 Termination		49
15.2.1 Termination for Breach		49
15.2.2 Termination for Challenge		49
15.2.3 Termination for Change of Control		49
15.2.4 Voluntary Termination		49
15.2.5 Termination for []*		49
15.2.6 []*		49
15.2.6.1 Conditions		49

Page 5 of 65


15.2.6.2 Good Faith Discussion		49
15.2.6.3 Notice; Effectiveness		49
15.3 Effect of Termination		50
15.3.1 General		50
15.3.2 Intellectual Property Licenses		50
15.3.3 Development Cost Share		50
15.3.4 []*		51
15.3.5 []*		51
15.4 Additional Surviving Provisions		51
15.5 Transition Period		51
15.6 [*]		51

16. MISCELLANEOUS		52
16.1 Affiliates		52
16.2 Assignment		52
16.3 Choice of Law		52
16.4 Construction		52
16.5 Counterparts		53
16.6 Currency		53
16.7 Entire Agreement		53
16.8 Force Majeure		53
16.9 Further Assurances		53
16.10 Headings		54
16.11 Jurisdiction and Venue		54
16.12 No Set-Off		54
16.13 Notices		54
16.14 Relationship of the Parties		55
16.15 Severability		55
16.16 Third Party Beneficiaries		55
16.17 Waivers and Modifications		55
16.18 Reimportation		55

SCHEDULES
Development Costs
Development Costs Example
Dmab Amino Acid Sequence
Form of Press Release
Licensed Amgen Patents
Licensed Collaborator Patents
Settled Patents
Supply Agreement Term Sheet

Page 6 of 65

Collaboration Agreement

This Collaboration Agreement (this “Agreement” ) is entered into as of the 11 ^th day of July, 2007 (the “Effective Date” ) by and between Amgen Inc., a Delaware corporation having its principal place of business at One Amgen Center Drive, Thousand Oaks, CA 91320-1799 ( “Amgen” ) and Daiichi Sankyo Company, Limited, a Japanese corporation with a principal place of business at 3-5-1 Nihonbashi-honcho, Chuo-ku, Tokyo 103-8426 ( “Collaborator” ). Amgen and Collaborator are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”

Recitals

WHEREAS, Amgen is a global biotechnology company that conducts pharmaceutical research, development, manufacturing and commercialization;

WHEREAS, Amgen is developing Dmab (as defined below) for the potential treatment of osteoporosis, cancer, rheumatoid arthritis, and other diseases and conditions;

WHEREAS, Amgen wishes to partner with Collaborator for the development and commercialization of Dmab in the Territory (as defined below) in accordance with the terms and conditions hereof;

WHEREAS, Collaborator has existing development and commercialization capabilities in the Territory;

WHEREAS, Collaborator wishes to partner with Amgen with respect to the development and commercialization of Dmab in the Territory in accordance with the terms and conditions hereof;

WHEREAS, the Parties have disputes [*] of various patents relating to [*] owned by each of the Parties [*] (collectively the “Patent Disputes”) ; and

WHEREAS, the Parties wish to [*] settle the Patent Disputes on a world-wide basis.

NOW, THEREFORE, in consideration of the mutual promises contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound, the Parties hereto agree as follows:

1. D EFINITIONS

1.1.

“Affiliate” shall mean any corporation or other entity which directly or indirectly controls, is controlled by or is under common control with a Party, for so long as such control exists. For the purposes of this Section 1.1 (“Affiliate”), “control” shall mean: (i) in the case of any corporate entity, direct or indirect ownership of more than fifty percent (50%) of the stock having the right to vote for the election of directors thereof; or (ii) in the case of any non-corporate entity, direct or indirect ownership of more than fifty percent (50%) of the equity or income interest therein.

1.2.	“Aggregate Maximum” shall have the meaning set forth in Section 8.8.2 (Maximum Payments).

1.3.	“Agreement” shall have the meaning set forth in Page 3, Paragraph 1 .

Page 7 of 65

1.4.	“Amgen Additional Indication” shall have the meaning set forth in Section 6.2.1 (Amgen Developed Indications).

1.5.	“Amgen Assumed Item” shall have the meaning set forth in Section 10.3.1.2 (Amgen [*] Prosecution).

1.6.	“Amgen Development Costs” shall mean Amgen’s (and its Affiliates’) fully-burdened, world-wide development costs [*] related to development of Dmab, as more specifically set forth in the Development Costs Schedule.

1.7.	“Amgen Development Data” shall mean the preclinical and clinical data generated by or on the behalf of Amgen or its Affiliates (both within and outside the Territory) in the course of its preclinical and clinical development of Dmab, both before and after the Effective Date of this Agreement.

1.8.	“Amgen Indemnitees” shall have the meaning set forth in Section 14.1 (Indemnity).

1.9.	“Amgen Net Sales” shall mean Net Sales in the Territory made by or on the behalf of Amgen, its Affiliates or licensees. Amgen Net Sales shall not include sales made to, by or on behalf of Collaborator.

1.10.

“Annual Maximum” shall have the meaning set forth in Section 8.8.2 (Maximum Payments).

1.11.

“Bundle” shall mean Dmab sold together with another pharmaceutical compound for a single price.

1.12.

“Calendar Quarter” shall mean a three-month period beginning on January, April, July or October 1 ^st .

1.13.

“Calendar Year” shall mean a one-year period beginning on January 1 ^st and ending on December 31 ^st .

1.14.

“Change of Control” shall mean, with respect to a Party, the occurrence of any of the following events: [*].

1.15.

“Claims” shall have the meaning set forth in Section 14 (Indemnification).

1.16.

“Collaboration” shall mean the activities conducted by the Parties hereunder with respect to the development and commercialization of Dmab in the Territory, as described in more detail herein.

1.17.

“Collaborator” shall have the meaning set forth in Page 3, Paragraph 1.

1.18.

“Collaborator Development Data” shall mean the preclinical and clinical data generated by or on behalf of Collaborator or its Affiliates in the course of its preclinical (if any) and clinical development of Dmab, on or after the Effective Date of this Agreement.

1.19.

“Collaborator Indemnitees” shall have the meaning set forth in Section 14.1 (Indemnity).

1.20.

“Collaborator Indications” shall mean: (i) any and all uses for Oncology indications being developed by Amgen outside the Territory; (ii) any and all uses for the treatment, palliation, prevention or prophylaxis of osteoporosis or rheumatoid arthritis; and (iii)

Page 8 of 65

any other indications that have been added to the definition of Collaborator Indication pursuant to Sections 6.2.1 (Amgen Developed Indications) or 6.2.2 (Collaborator Proposed Indications).

1.21.

“Collaborator Net Sales” shall mean Net Sales made by or on behalf of Collaborator, its Affiliates or licensees in the Territory.

1.22.

“Commercialization Committee” shall mean the committee established by the Parties to oversee and coordinate the commercialization of Dmab in the Territory.

1.23.

“Competing Product” shall mean: (i) any [*], [*],[*]; and (ii) any product that, as a therapeutic mechanism of action,[*]. Competing Product shall not include Dmab.

1.24.

“Competing Program” shall mean the [*], in the Territory, of any Competing Product. Notwithstanding the foregoing, [*] of a Competing Product in the Territory [*]of such Competing Product [*] shall not be considered a Competing Program.

1.25.

“Competing Transaction” shall mean any transaction entered into by a Party or its Affiliate after the Effective Date whereby a Third Party that is engaged in a Competing Program becomes an Affiliate of such Party.

1.26.

“Competing Transaction Affiliates” shall mean those entities that become Affiliates of a Party by virtue of a Competing Transaction.

1.27.

“Competing Transaction Party” shall mean the Party that enters into a Competing Transaction.

1.28.

“Confidential Information” shall have the meaning set forth in Section 11.1 (Confidentiality; Exceptions).

1.29.

“Contract Interest Rate” shall mean [*] plus the [*] rate effective for the date that payment was due, as published by The Wall Street Journal , Eastern U.S. Edition, on the date such payment was due (or, if unavailable on such date, the first date thereafter on which such rate is available), or, if lower, the maximum rate permitted by Law.

1.30.

“Control” shall mean, with respect to any Information or intellectual property, that the applicable Party owns or has a license to such Information or intellectual property and has the ability to grant to the other Party access to and a license or sublicense (as applicable) under such Information or intellectual property as set forth herein without violating the terms of any agreement with any Third Party as of the time such Party would first be required hereunder to grant such access and license or sublicense, or requiring any payment under any agreement with any Third Party.

1.31.

“Defending Party” shall have the meaning set forth in Section 10.4 (Defense and Settlement of Third Party Claims).

1.32.

“Development Committee” shall mean the committee established by the Parties to oversee and coordinate the development of Dmab in the Territory.

1.33.

“Divest” shall mean, with respect to any Competing Program, the sale, exclusive license or other transfer of all of the right, title and interest in and to such Competing Program, including technology, intellectual property and other assets materially relating thereto, to an independent Third Party, without the retention or reservation of any rights or interest (other than solely an economic interest) in such Competing Program by the Competing Transaction Party or its Affiliates.

Page 9 of 65

1.34.

“Dmab” shall mean Amgen’s proprietary product denosumab, a fully human monoclonal antibody that targets the receptor activator of nuclear factor Kappa B Ligand. [*].

1.35.

“Effective Date” shall have the meaning set forth in Page 3, Paragraph 1.

1.36.

“Federal Court” shall have the meaning set forth in Section 16.11 (Jurisdiction and Venue).

1.37.

“First Commercial Sale” shall mean the first sale of Dmab following Regulatory Approval by or on the behalf of Amgen or Collaborator, or its or their respective Affiliates or licensees.

1.38.

“Force Majeure” shall have the meaning set forth in Section 16.8 (Force Majeure).

1.39.

“FTE” shall mean the equivalent of the work of one employee full time for one year (consisting of at least a total of 45.5 weeks or 1,820 hours per year (excluding vacations and holidays)). Overtime, and work on weekends, holidays and the like shall not be counted with any multiplier (e.g., time-and-a-half or double time) toward the number of hours that are used to calculate the FTE contribution.

1.40.

“FTE Rate” shall mean $[*] per full-time employee per year (as of the Effective Date), increasing by [*] ([*]%) of the then-current FTE Rate on January 1 ^st of 2008 and each subsequent Calendar Year.

1.41.

“GAAP” shall mean either Japanese or U.S. generally accepted accounting principles, consistently applied, as used by a Party to record the relevant transaction.

1.42.

“Governmental Authority” shall mean any government administrative agency, commission or other governmental authority, body or instrumentality, or any federal, state, local, domestic or foreign governmental regulatory body.

1.43.

“Indemnified Party” shall have the meaning set forth in Section 14.2 (Claim for Indemnification).

1.44.

“Indemnifying Party” shall have the meaning set forth in Section 14.2 (Claim for Indemnification).

1.45.

“Information” shall mean all tangible and intangible techniques, information, technology, practices, trade secrets, inventions (whether patentable or not), methods, knowledge, know-how, conclusions, skill, experience, test data and results (including pharmacological, toxicological and clinical test data and results), analytical and quality control data, results or descriptions, software and algorithms.

1.46.

“Joint Patents” shall mean any invention, patent or patent application jointly owned by the Parties pursuant to Section 10.1 (Ownership).

1.47.

“Law” shall mean, individually and collectively, any and all laws, ordinances, rules, directives and regulations of any kind whatsoever of any Governmental Authority within the applicable jurisdiction.

1.48.

“Licensed Amgen Know-How” shall mean Information in Amgen’s (or its Affiliate’s) possession and Control, as of the Effective Date or thereafter during the Term, that is reasonably necessary for Collaborator to develop or commercialize Dmab in the Territory in the Collaborator Indications. Licensed Amgen Know-How shall include

Page 10 of 65

Amgen Development Data that is reasonably necessary for Collaborator to develop or commercialize Dmab in the Territory in the Collaborator Indications. Licensed Amgen Know-How does not include Amgen manufacturing information.

1.49.

“Licensed Amgen Patents” shall mean those patents and patent applications set forth on the Licensed Amgen Patents Schedule, as well as any continuation, divisional, substitution, continuations-in-part, reissue, reexamination, provisional and converted provisional applications thereof [*]. For purposes of determining whether a patent application falls within this definition, a patent application shall be considered “infringed” if its pending claims would be infringed if issued as then currently set forth in the patent application.

1.50.

“Licensed Amgen Trademarks” shall mean any trademark rights Controlled by Amgen in the Territory on or after the Effective Date and corresponding to any trademarks adopted by Amgen for use with Dmab outside the Territory (not including any corporate or house marks, and not including any such marks to the extent such marks would conflict with any right of any Third Party inside the Territory).

1.51.

“Licensed Collaborator Know-How” shall mean Information in Collaborator’s (or its Affiliate’s) possession and Control, as of the Effective Date or thereafter during the Term, that is reasonably necessary for Amgen to develop or commercialize Dmab within or outside the Territory in any indication. Licensed Collaborator Know-How shall include Collaborator Development Data that is reasonably necessary for Amgen to develop or commercialize Dmab within or outside the Territory in any indication.

1.52.

“Licensed Collaborator Patents” shall mean those patents and patent applications set forth on the Licensed Collaborator Patents Schedule, as well as any continuation, divisional, substitution, continuations-in-part, reissue, reexamination, provisional and converted provisional applications thereof [*]. For purposes of determining whether a patent application falls within this definition, a patent application shall be considered “infringed” if its pending claims would be infringed if issued as then currently set forth in the patent application.

1.53.

“Licensed Collaborator Trademarks” shall mean any trademarks adopted by Collaborator for use with Dmab in the Territory in the Collaborator Indications (not including any corporate or house marks).

1.54.

“Losses” shall have the meaning set forth in Section 14.1 (Indemnity).

1.55.

“MHLW” shall mean the Japanese Ministry of Health, Labour and Welfare, and any successor agency thereto.

1.56.

“Net Sales” shall mean with respect to a given period, the gross invoiced sales price for Dmab sold by or for a Party, its Affiliates or licensees hereunder to Third Parties (not including such Party’s licensees hereunder, unless and to the extent such licensee is the end-user of such Dmab) during such period, less the total of the following charges or expenses, as determined in accordance with GAAP:

1.56.1.

Trade, cash, prompt payment and quantity discounts;

1.56.2.

Returns, allowances, rebates, chargebacks and payments to government agencies;

Page 11 of 65

1.56.3.

Retroactive price reductions;

1.56.4.

Fees paid to distributors, wholesalers, selling agents (excluding any sales representatives of a Party or any of its Affiliates), group purchasing organizations and managed care entities;

1.56.5.

Credits and allowances for product replacement, whether cash or trade; and

1.56.6.

Non-recoverable sales taxes, excise taxes, tariffs and duties (excluding taxes when assessed on income derived from sales); in each case, to the extent related to sales of Dmab in the Territory and actually given.

1.57.

“Oncology” shall mean any and all uses for the treatment, palliation, prevention or prophylaxis of cancer or other uncontrolled cell proliferation (including myeloma), and the treatment, palliation, prevention or prophylaxis of the effects of cancer or cancer treatment.

1.58.

“Ongoing Oncology Study” shall have the meaning set forth in Section 4.7 (Global Development).

1.59.

“Party/Parties” shall have the meaning set forth in Page 3, Paragraph 1.

1.60.

“Patent Disputes” shall have the meaning set forth in the recitals.

1.61.

“Payee Party” shall mean the Party receiving or entitled to receive a payment pursuant to Article 8 (Payment).

1.62.

“Payor Party” shall mean the Party making or obligated to make a payment pursuant to Article 8 (Payment).

1.63.

“Prior Agreement” shall have the meaning set forth in Section 11.4 (Prior Agreement).

1.64.

“Publishing Party” shall have the meaning set forth in Section 11.5 (Publications).

1.65.

“Quarterly Maximum” shall have the meaning set forth in Section 8.8.2 (Maximum Payments).

1.66.

“Reasonably Diligent Efforts” shall mean, with respect to a Party, the application of a level of resources, efforts and urgency to develop and commercialize Dmab consistent with such Party’s practices in pursuing the development and commercialization of its other high-value pharmaceutical products with similar value and market potential to Dmab in light of its characteristic features, target indication, competitiveness and sales volume, but in no event less than the high professional standards and level commonly applied by other pharmaceutical companies to their high-value pharmaceutical products. For clarity, it is understood that Reasonably Diligent Efforts shall not take into account: (i) any other pharmaceutical product such Party is then discovering, researching, developing, manufacturing or commercializing outside the Collaboration, alone or with one or more collaborators; or (ii) the payments required to be made by such Party to the other Party pursuant to this Agreement.

1.67.

“Recall” means a “recall” (as per Article 70 of the Japanese Pharmaceutical Affairs Law) or “market withdrawal” (as per Article 77-4-3 of the Japanese Pharmaceutical Affairs Law) of Dmab or any lots thereof.

Page 12 of 65

1.68.

“Recoveries” shall mean all cash amounts (plus the fair market value of all non-cash consideration) received by a Party from a Third Party in connection with the final judgment, award or settlement of any enforcement with respect to any Licensed Amgen Patent, Licensed Amgen Trademark, Licensed Amgen Know-How, Licensed Collaborator Patent, Licensed Collaborator Trademark, Licensed Collaborator Know-How, or Joint Patent, each of the foregoing in the Territory.

1.69.

“Regulatory Approval” shall mean the product-specific approvals necessary for the distribution, use and sale of Dmab.

1.70.

“Regulatory Filing” shall mean any filing with any Governmental Authority with respect to the development, marketing, commercialization or reimbursement of Dmab.

1.71.

“[*]” shall mean clinical development that, as reasonably demonstrated by [*], either: (i) is [*]; or (ii) [*].

1.72.

“Reviewing Party” shall have the meaning set forth in Section 11.5 (Publications).

1.73.

“Settled Patents” shall mean all patents and patent applications set forth on the Settled Patents Schedule, as well as any continuation, divisional, substitution, continuations-in-part, reissue, reexamination, provisional and converted provisional applications thereof, as well as any patent or patent application [*] as well as any continuations, divisionals, substitutions, continuations-in-part, reissues, reexaminations, provisional and converted provisional applications thereof.

1.74.

“Sites” shall have the meaning set forth in Section 4.18 (Transition in Oncology Development).

1.75.

“SOPs” shall have the meaning set forth in Section 4.16 (Recalls).

1.76.

“SPC” shall mean any patent term extension or related extension of rights, including supplementary protection certificates and similar rights.

1.77.

“State Court” shall have the meaning set forth in Section 16.11 (Jurisdiction and Venue).

1.78.

“Taxes” shall mean any tax, excise or duty, other than taxes upon income.

1.79.

“Term” shall mean the period beginning on the Effective Date and ending on [*], any sooner termination of this Agreement pursuant to Article 15 (Term and Termination) or, in the event of a written extension to this Agreement, such date as specified therein.

1.80.

“Termination Date” shall have the meaning set forth in Section 15.3.1.

1.81.

“Territory” shall mean Japan.

1.82.

“Territory IP” shall have the meaning set forth in Section 10.5.1 (In Territory).

1.83.

“Territory Patents and Trademarks” shall have the meaning set forth in Section 10.3.1.1 (Collaborator [*] Prosecution).

1.84.

“Third Party” shall mean any entity other than a Party or an Affiliate of a Party.

1.85.

“Transition Period” shall have the meaning set forth in Section 15.5 (Transition Period).

Page 13 of 65

1.86.

“VAT” shall mean any value added tax.

1.87.

Additional Definitions. Each of the following capitalized terms shall have the meanings set forth in the corresponding Sections of this Agreement indicated in the table below:


Definition		Section
“Amgen”		Preamble

“Amgen K.K.”		Section 3.7.1

“Amgen Royalty Percentage”		Section 15.3.5

“Drug Product”		Schedule: Supply Agreement Term Sheet

“Oncology Approval”		Section 8.1.2

“Partnering Share Percentage”		Section 15.3.5

“Prior Agreement”		Section 11.4

2. C OLLABORATION S COPE AND G OVERNANCE

2.1.	Conduct of the Collaboration . The Parties shall cooperate to develop and commercialize Dmab in the Territory, in accordance with the terms and conditions of this Agreement.

2.2.

Ex-Territory Activities . The Parties acknowledge that no rights are granted hereunder to Collaborator with respect to any country outside the Territory, and that Collaborator shall have no authority with respect to the research, development, manufacture or commercialization of Dmab outside the Territory. Amgen shall have the sole right to research, develop, manufacture and commercialize Dmab outside the Territory.

2.3.

Activities in Competition with the Collaboration . Except as set forth in Sections 2.4 (Post-Effective Date Affiliates) and 2.5 (Termination or Divestiture), during the Term, [*] shall, itself or through its Affiliates, conduct, participate in, or advise, assist or enable any Third Party to conduct or participate in, any Competing Program.

2.4.

Post-Effective Date Affiliates . In the event that either Party enters into a Competing Transaction then the Competing Transaction Party shall provide notice to the other Party, within five (5) business days of the closing of the Competing Transaction, specifying the identity of the Competing Transaction Affiliate(s) and describing in reasonable detail, to the extent permitted by Law and without disclosing any proprietary information, the Competing Program and its focus. During the pendency of any potential Competing Transaction, and until the provisions of Section 2.5 (Termination or Divestiture) are effectuated, the Competing Transaction Party shall ensure that information and materials relating to the Collaboration are not shared with or used for the benefit of, and are sequestered from, such Competing Transaction Affiliate(s).

Page 14 of 65

2.5.

Termination or Divestiture . The notice provided pursuant to Section 2.4 (Post-Effective Date Affiliates) shall include a notification as to whether the Competing Transaction Party intends to: (i) Divest the Competing Program, in which case the Competing Transaction Party shall hold separate such Competing Program (including ensuring that no personnel working directly on the Collaboration works on a Competing Program (and vice versa), and ensuring that information from the Collaboration is sequestered from personnel working directly on the Competing Program (and vice versa)) and use its commercially reasonable, good-faith efforts to Divest such Competing Program; in the foregoing case, the Competing Transaction Party and its Affiliates (including Competing Transaction Affiliates) shall not assert any intellectual property or proprietary right of the Competing Program to obstruct the Parties’ (or their Affiliates’ or sublicensees’) efforts under the Collaboration or Amgen’s (or its Affiliates’ or sublicensees’) efforts with respect to Dmab outside the Territory during such divestiture period; (ii) terminate such Competing Program, in which case the Competing Transaction Party shall terminate all activities of such program within one hundred and twenty (120) days of the closing of the Competing Transaction, during which period the Competing Transaction Party shall hold separate such Competing Program (including ensuring that no personnel working directly on the Collaboration works on a Competing Program (and vice versa), and ensuring that information from the Collaboration is sequestered from personnel working directly on the Competing Program (and vice versa)); in the foregoing case, the Competing Transaction Party and its Affiliates (including Competing Transaction Affiliates) shall not assert any intellectual property or proprietary right of the Competing Program to obstruct the Parties’ (or their Affiliates’ or sublicensees’) efforts under the Collaboration or Amgen’s (or its Affiliates’ or sublicensees’) efforts with respect to Dmab outside the Territory during such termination period or thereafter; or (iii) if Collaborator is the Party providing such notice, [*] pursuant to Section [*] unless the Competing Program constituted the majority of the assets acquired by Collaborator in the Competing Transaction in which case such [*]; during the pendency of such termination and any transition pursuant to Section 15.5 (Transition Period), Collaborator shall hold separate such Competing Program (including ensuring that no personnel working directly on the Collaboration works on a Competing Program (and vice versa), and ensuring that information from the Collaboration is sequestered from personnel working directly on the Competing Program (and vice versa)). In the event the Competing Transaction Party selects option (i) and fails to complete such divestiture within one year of the closing of the Competing Transaction, then such Party shall be deemed to have chosen option (ii), effective as of such one year anniversary, and shall promptly comply with the requirements of such subsection (ii), above.

2.6.	Governance . The Collaboration shall be governed by a Development Committee and a Commercialization Committee, which shall coordinate and oversee the development and commercialization, respectively, of Dmab in the Territory. Each such committee shall be formed promptly following the Effective Date.

2.7.	Membership . Each of the committees shall be comprised of three (3) members appointed by Amgen, and three (3) members appointed by Collaborator. Each committee shall be led by two (2) co-chairs, one (1) appointed by each of the Parties.

Page 15 of 65

Each of the committees shall have the right to delegate any of its responsibilities to one or more subcommittees as it determines appropriate.

2.8.

Replacement of Members . Each Party shall have the right to replace its committee members or co-chairs by written notice to the other Party. In the event any committee member or co-chair becomes unwilling or unable to fulfill his or her duties hereunder, the Party that appointed such member shall promptly appoint a replacement by written notice to the other Party.

2.9.	Input from other Personnel . Any committee member shall have the right to solicit input or assistance from any other personnel of the Party that appointed such member.

2.10.

No Authority to Amend or Modify . Notwithstanding anything herein to the contrary, no committee shall have any authority to amend, modify or waive compliance with this Agreement.

2.11.

Development Committee . The Development Committee shall be responsible for: (i) reviewing and approving development plans (and changes thereto) for Dmab in the Territory prior to adoption of such plans or changes by a Party; (ii) providing for communication and discussion between the Parties to optimize the efficacy and safety of the development of Dmab in the Territory; (iii) reviewing and monitoring the activities and progress against the development plans, including site enrollment, patient enrollment, progress of trials and data received; (iv) communicating with the Commercialization Committee regarding the interrelationship between development activities and potential commercialization of Dmab in the Territory; (v) monitoring and reporting on the competitive landscape for Dmab in the Territory (in consultation with the Commercialization Committee); and (vi) communicating with the Parties regarding all of the foregoing.

2.11.1.

Meetings . The Development Committee shall meet quarterly in person or telephonically (with at least two meetings per Calendar Year being in person), more frequently as may be required by ongoing development activities, or as otherwise agreed by the Parties. Any in-person meetings shall be held on an alternating basis between Collaborator’s and Amgen’s facilities, unless otherwise agreed by the Parties. Each Party shall be responsible for its own expenses relating to such meetings. As appropriate, other employee representatives of the Parties may attend Development Committee meetings as nonvoting participants, but no Third Party personnel may attend unless otherwise agreed by the Parties. Each Party may also call for special meetings as reasonably required to resolve particular matters requested by such Party by at least five (5) business days written notice to the co-chair appointed by the other Party.

2.11.2.

Reporting . Each Party shall keep the Development Committee fully and promptly informed of progress and results of development activities for which it is responsible or that it is permitted to conduct hereunder through its members on the Development Committee and as otherwise provided herein, including by promptly providing copies of all clinical data and results for Dmab as reasonably requested by the other Party. Each Party shall fully inform the Development Committee with respect to all relevant facts and activities regarding any Dmab

Page 16 of 65

development matter reasonably requested by any member thereof. At least five (5) business days prior to the first Development Committee meeting of each Calendar Quarter, each Party shall deliver to the Development Committee a written summary of development activities conducted hereunder and material clinical data and results received by each such Party since the last such report.

2.11.3.

Development Plans . At least five (5) business days prior to the first Development Committee meeting of each Calendar Year, Collaborator (and, during the transition period referenced in Section 15.5 (Transition Period) and any other period during which Amgen is developing any Amgen Additional Indication in the Territory, Amgen) shall provide the Development Committee a copy of its proposed development plan for Dmab in the Territory for the next four Calendar Quarters for the Development Committee’s review, comment and approval (with Collaborator and Amgen (should Amgen be developing any Amgen Additional Indication in the Territory) each having its own development plan (either by indication or for all indications for which it is responsible in the Territory)). In addition, should a Party seek to make material changes to an approved development plan, then at least five (5) business days prior to the next meeting of the Development Committee it shall provide the Development Committee any proposed changes to the previously approved development plan for the Development Committee’s approval.

2.11.4.

Decision Making . The Development Committee shall strive to reach consensus on decisions, taking into account the views of each committee member. In the event the committee fails to reach consensus, the committee [*] determination unless the decision relates primarily to [*], in which case the committee [*] determination (in all cases subject to [*]).

2.12.

Commercialization Committee . The Commercialization Committee shall be responsible for: (i) reviewing and approving commercialization plans (and changes thereto) for Dmab in the Territory prior to adoption of such plans or changes by a Party; (ii) communicating with the Development Committee regarding the interrelationship between development activities and potential commercialization of Dmab in the Territory; (iii) reviewing and monitoring the activities and progress against the commercialization plans; (iv) monitoring and reporting on the competitive landscape for Dmab in the Territory; (v) establishing appropriate processes for coordinating review of promotional materials for the Territory to ensure compliance with Law and industry best practices; (vi) overseeing the trademark and publication strategies for the Territory; and (vii) communicating with the Parties regarding all of the foregoing.

2.12.1.

Meetings . The Commercialization Committee shall meet quarterly in person or telephonically (with at least two meetings per Calendar Year being in person), more frequently as may be required by ongoing commercialization activities, or as otherwise agreed by the Parties. Any in-person meetings shall be held on an alternating basis between Collaborator’s and Amgen’s facilities, unless otherwise agreed by the Parties. Each Party shall be responsible for its own expenses relating to such meetings. As appropriate, other employee representatives of the Parties may attend Commercialization Committee

Page 17 of 65

meetings as nonvoting participants, but no Third Party personnel may attend unless otherwise agreed by the Parties. Each Party may also call for special meetings as reasonably required to resolve particular matters requested by such Party by at least five (5) business days written notice to the co-chair appointed by the other Party.

2.12.2.

Reporting . Each Party shall keep the Commercialization Committee fully and promptly informed of progress and results of commercialization activities in the Territory for which it is responsible or that it is permitted to conduct hereunder through its members on the Commercialization Committee and as otherwise provided herein. Each Party shall fully inform the Commercialization Committee with respect to all relevant facts and activities regarding any Dmab commercialization matter reasonably requested by any member thereof. At least five (5) business days prior to the first Commercialization Committee meeting of each Calendar Quarter, each Party shall deliver to the Commercialization Committee a written summary of commercialization activities conducted hereunder by each such Party since the last such report.

2.12.3.

Commercialization Plans . At least five (5) business days prior to the first Commercialization Committee meeting of each Calendar Year, Collaborator (and should Amgen be commercializing any Amgen Additional Indication in the Territory, Amgen) shall provide the Commercialization Committee a copy of its proposed commercialization plan for Dmab in the Territory for the next four Calendar Quarters for the Commercialization Committee’s review, comment and approval (with Collaborator and Amgen (should Amgen be commercializing any Amgen Additional Indication in the Territory) each having its own commercialization plan (either by indication or for all indications for which it is responsible in the Territory)). In addition, should a Party seek to make material changes to an approved commercialization plan, then at least five (5) business days prior to the next meeting of the Commercialization Committee it shall provide the Commercialization Committee any proposed changes to the previously approved commercialization plan for the Commercialization Committee’s approval.

2.12.4.

Decision Making . The Commercialization Committee shall strive to reach consensus on decisions, taking into account the views of each committee member. In the event the committee fails to reach consensus, the committee [*] determination unless the decision relates primarily to [*], in which case the committee [*] determination.

3. G RANT OF L ICENSE

3.1.

Licensed Amgen Patents . Amgen hereby grants Collaborator [*] (except as otherwise expressly set forth herein (such exception to include the transition periods described in Section 4.18 (Transition in Oncology Development) and Section 15.5 (Transition Period))) right and license during the Term, subject to the terms and conditions hereof, solely to develop, commercialize, use and sell Dmab in the Territory for the

Page 18 of 65

Collaborator Indications under the Licensed Amgen Patents. Such license shall include the right to sublicense only as set forth in Section 3.5 (Collaborator Sublicensing).

3.2.

Licensed Amgen Know-How . Amgen hereby grants Collaborator [*] right and license during the Term, subject to the terms and conditions hereof, to utilize the Licensed Amgen Know-How solely for the purpose of supporting its development, commercialization, use and sale of Dmab in the Territory for the Collaborator Indications. Such license shall include the right to sublicense only as set forth in Section 3.5 (Collaborator Sublicensing).

3.3.

Licensed Collaborator Patents . Collaborator hereby grants Amgen [*] right and license under the Licensed Collaborator Patents, subject to the terms and conditions hereof, solely to develop, commercialize, make, have made, use, import, sell and offer for sale [*] for all uses. Such [*]shall be subject to a retained exclusive right in the Territory during the Term solely for Collaborator to develop, commercialize, use and sell Dmab in the Territory for the Collaborator Indications. Such license shall include the right to sublicense [*] provided, however, that: (i) any sublicensee shall be required to enter into a written agreement obligating it to maintain the confidentiality of the Confidential Information of Collaborator; (ii) Amgen shall be responsible for any disclosure of the Confidential Information of Collaborator by such sublicensee in violation of the provisions of Article 11 (Confidentiality and Publications); (iii) no such sublicense shall operate to excuse Amgen’s compliance with its obligations hereunder; (iv) to the extent that such sublicense grants rights with respect to the Territory, it shall require such sublicensee to comply with the obligations and prohibitions of this Agreement relevant to the right(s) sublicensed; and (v) Amgen shall be responsible for a breach by such sublicensee of any such obligations or prohibitions. For the avoidance of doubt, Collaborator is retaining the right to develop, commercialize, make, have made, use, import, sell and offer for sale products and services other than [*] under the Licensed Collaborator Patents and no rights with respect to products and services other than [*] are granted to Amgen hereunder.

3.4.

Licensed Collaborator Know-How . Collaborator hereby grants Amgen [*] right and license, subject to the terms and conditions hereof, to utilize the Licensed Collaborator Know-How solely for the purpose of supporting its development, commercialization, manufacture, use and sale of [*]: (x) in the Territory, outside the Collaborator Indications during the Term and for all uses thereafter; and (y) outside the Territory for all uses both during the Term and thereafter. Such license shall include the right to sublicense [*] provided, however, that (i) any sublicensee shall be required to enter into a written agreement obligating it to maintain the confidentiality of the Confidential Information of Collaborator; (ii) Amgen shall be responsible for any disclosure of the Confidential Information of Collaborator by such sublicensee in violation of the provisions of Article 11 (Confidentiality and Publications); (iii) no such sublicense shall operate to excuse Amgen’s compliance with its obligations hereunder; (iv) to the extent that such sublicense grants rights with respect to the Territory, it shall require such sublicensee to comply with the obligations and prohibitions of this Agreement relevant to the right(s) sublicensed; and (v) Amgen shall be responsible for a breach by such sublicensee of any such obligations or prohibitions. Notwithstanding the foregoing, the license granted in this Section 3.4 (Licensed Collaborator Know-How) shall be exclusive to the extent the relevant Licensed Collaborator Know-How is developed in the course of the Collaboration.

Page 19 of 65

3.5.

Collaborator Sublicensing . Collaborator shall have the right to sublicense the rights granted it hereunder only with Amgen’s prior written consent, which Amgen may withhold or condition in its sole discretion. Any permitted sublicensee shall be required to enter into a written agreement obligating it to maintain the confidentiality of the Confidential Information of Amgen and Collaborator shall be responsible for any disclosure of the Confidential Information of Amgen by such sublicensee in violation of the provisions of Article 11 (Confidentiality and Publications). In addition, such written agreement shall require such sublicensee to comply with the obligations and prohibitions of this Agreement relevant to the right(s) sublicensed, and Collaborator shall be responsible for a breach by such sublicensee of any such obligations or prohibitions. No sublicense shall operate to excuse Collaborator’s compliance with its obligations hereunder. Collaborator shall have the right to distribute Dmab in the Territory through reputable distributors.

3.6.

Provision of Know-How . Following the Effective Date, the Parties shall cooperate to establish procedures for the provision of Licensed Amgen Know-How to Collaborator and Licensed Collaborator Know-How to Amgen. During the Term, Amgen shall use reasonable efforts to provide all material Licensed Amgen Know-How to Collaborator, and Collaborator shall use reasonable efforts to provide all material Licensed Collaborator Know-How to Amgen. In any event, each of the Parties shall provide to the other any Licensed Amgen Know-How or Licensed Collaborator Know-How (respectively) as the other Party shall reasonably request. Notwithstanding the foregoing, Amgen shall have no obligation to provide manufacturing information to Collaborator and neither Party shall have an obligation to provide information relating to any product other than Dmab.

3.7.	Trademarks .

3.7.1.

Grant to Collaborator . Amgen hereby grants Collaborator [*] (except as otherwise expressly set forth herein (such exception to include Amgen’s co-promotion rights pursuant to Section 5.2 (Amgen Co-Promotion Right) and the transition period described in Section 15.5 (Transition Period)) right and license during the Term, subject to the terms and conditions hereof, solely to develop, commercialize, use and sell Dmab in the Territory in the Collaborator Indications under the same Licensed Amgen Trademarks as used by Amgen in the corresponding indications outside the Territory. Such license shall include the right to sublicense only as set forth in Section 3.5 (Collaborator Sublicensing). Such license is subject to Amgen’s retained right to utilize such Licensed Amgen Trademarks in the Territory outside Collaborator Indications. The Parties acknowledge that the use of the Licensed Amgen Trademarks in the Territory may have commercial value to Collaborator, and that Collaborator shall have the right to commercialize Dmab in the Collaborator Indications in the Territory under the same Licensed Amgen Trademarks as utilized for such indications by Amgen outside the Territory. Should the Parties desire that a different trademark be used for Collaborator Indications in the Territory, or if

Page 20 of 65

additional trademarks to those used outside the Territory are otherwise required, the Parties shall consult and agree upon an additional or replacement trademark (or trademarks). Upon Amgen’s request, Collaborator shall include an Amgen trademark designated by Amgen to Collaborator in writing (e.g., “Amgen” or “Amgen K.K.”) on all packaging, labeling, promotional and marketing materials for Dmab in equal prominence to those of Collaborator. Collaborator shall utilize those Amgen trademarks as requested by Amgen to the extent that Amgen provides the necessary trademark approvals within thirty (30) days of request by Collaborator for such approval. Amgen hereby grants Collaborator a non-exclusive right and license, with the right to sublicense as set forth in Section 3.5 (Collaborator Sublicensing), during the Term, subject to the terms and conditions hereof, to use such marks solely for such purpose.

3.7.2.

Grant to Amgen . Collaborator hereby grants Amgen a [*] license during the Term to use Licensed Collaborator Trademarks to the extent Amgen desires or may be required to utilize the same in connection with its development and commercialization of Dmab in the Territory hereunder[*]. Subject to the foregoing, such license shall include the right to sublicense [*]. Any sublicensee shall be required to enter into a written agreement obligating it to comply with the provisions of Section 3.8 (Trademark Quality Standards). No such sublicense shall operate to excuse Amgen’s compliance with its obligations hereunder. To the extent that such sublicense grants rights with respect to the Territory, it shall require such sublicensee to comply with the obligations and prohibitions of this Agreement relevant to the right(s) sublicensed, and Amgen shall be responsible for a breach by such sublicensee of any such obligations or prohibitions. Upon any termination or expiration of this Agreement, Collaborator shall, upon Amgen’s request but at no charge, promptly assign the Licensed Collaborator Trademarks (and the associated goodwill) to Amgen.

3.8.

Trademark Quality Standards . Each Party shall (i) maintain such reasonable quality standards for the Licensed Amgen Trademarks (with respect to Collaborator) or the Licensed Collaborator Trademarks (with respect to Amgen) as it maintains for its own trademarks of a similar nature and shall comply with the other Party’s reasonable specifications and usage standards supplied to it in writing (and as may be updated by written notice from time to time); (ii) not use any Licensed Amgen Trademark (with respect to Collaborator) or Licensed Collaborator Trademark (with respect to Amgen) in a manner that suggests any connection with any product other than Dmab or any service; and (iii) not use or display the Licensed Amgen Trademarks (with respect to Collaborator) or the Licensed Collaborator Trademarks (with respect to Amgen) in any manner that might dilute, tarnish, disparage or reflect adversely on the other Party or such marks. Prior to using any Licensed Amgen Trademark (with respect to Collaborator) or Licensed Collaborator Trademark (with respect to Amgen), the Parties shall agree upon a guideline for use of such trademarks, including the review procedure and timing. From time to time, upon request by a Party, the other Party shall provide copies of the usage of the Licensed Amgen Trademarks (with respect to Collaborator) or Licensed Collaborator Trademarks (with respect to Amgen) used in the marketing or promotion of Dmab in order to review such usage. Amgen agrees that it shall not seek

Page 21 of 65

to register or obtain ownership rights in any Licensed Collaborator Trademark (or confusingly similar trademark) and Collaborator agrees that it shall not seek to register or obtain ownership rights in any Licensed Amgen Trademark or any trademark used by Amgen in connection with Dmab outside the Territory in any indication (or confusingly similar trademark to any of the foregoing).

3.9.

Retained Rights and Limitations . No rights are granted to Collaborator hereunder to Licensed Amgen Patents, Licensed Amgen Know-How or Licensed Amgen Trademarks outside the Collaborator Indications, or outside the Territory. No rights are granted to Collaborator hereunder to make or have made Dmab or any other product. No rights are granted herein to Collaborator to control the research, development or commercialization of Dmab outside the Territory. No rights to either Party’s patents, trademarks or other proprietary rights are granted pursuant to this Agreement except as expressly set forth herein, and all other rights are reserved.

4.	D EVELOPMENT AND R EGULATORY A PPROVAL

4.1.

Responsibility for Development in Collaborator Indications . Collaborator shall develop Dmab in Collaborator Indications in the Territory in accordance with the then-current development plan approved by the Development Committee for such Collaborator Indications. Collaborator’s responsibility with respect to Collaborator Indications in the Territory shall include: (a) filing for and seeking Regulatory Approval in the name of Collaborator from the relevant Governmental Authorities; (b) identifying and carrying out all major development tasks to be conducted prior to submission of filings for Regulatory Approval of Dmab in the Territory for a particular Collaborator Indication and any post-approval activities to be conducted for any such Collaborator Indication; (c) identifying key development objectives, expected associated resources, risk factors, timelines, decision points and relevant decision criteria; (d) carrying out all aspects of all clinical trials necessary to obtain Regulatory Approval in the name of Collaborator in the Territory for each Collaborator Indication pursued (including post-approval clinical studies) including, but not limited to, (i) designing study protocols; (ii) establishing/contracting with clinical trial sites, investigators and clinical research organizations, (iii) enrolling clinical trial subjects, (iv) organizing investigator meetings, scientific meetings, advisory panel workshops and regulatory meetings, and (v) analyzing and summarizing clinical trial results; (e) performing any other additional clinical research in support of the clinical development of Dmab; (f) forecasting clinical manufacturing production requirements; and (g) reporting on study design, study outcome, other communications and regulatory filings to the appropriate Governmental Authority. Collaborator shall be solely responsible for its costs incurred in its development of Dmab.

4.2.

Preclinical Development in Collaborator Indications . Notwithstanding the provisions of Section 4.1 (Responsibility for Development in Collaborator Indications), Amgen shall be responsible for performing (itself or through a subcontractor) any preclinical research that is required (as reasonably demonstrated by written communication from or written meeting minutes of discussions with the relevant Governmental Authority) in order to conduct development of Dmab in one or more Collaborator Indications in the Territory in accordance with this Agreement. [*]. Such research shall be conducted in

Page 22 of 65

accordance with a research plan to be agreed in writing by Amgen and Collaborator. Notwithstanding the foregoing, should [*] is likely to [*], then it shall notify [*]. In such case, [*]. Upon the request of either Party, the Parties shall [*], and should such [*], then [*] in accordance with Section [*].

4.3.

[*]. Should Collaborator determine to [*] of Dmab for the [*] (including with respect to [*] and including [*]), Collaborator shall give Amgen prompt prior written notice thereof. The Parties shall promptly meet to discuss [*] and Collaborator shall, thereafter, have the right to [*] in accordance with such [*] unless [*] that [*] that such [*] would [*] of Dmab [*]. In such event the Parties [*]. Notwithstanding the above, if such development [*], then Collaborator [*] in accordance with [*]. Prior to any such [*], and Collaborator shall [*] as requested by Amgen [*]. Notwithstanding the foregoing, should [*] is likely to [*] of Dmab [*], then Amgen shall notify Collaborator of the same. In such case, Collaborator shall [*]. Upon the request of either Party, the Parties shall meet to discuss [*] and, should the Parties [*], and should [*], [*] shall have the right to [*] in accordance with [*].

4.4.	Development in Combination or Outside Territory . Collaborator shall not, without Amgen’s prior express written consent, conduct any development of Dmab outside the Territory, or conduct any development of Dmab in combination with any other pharmaceutical product.

4.5.

Responsibility for Development in Amgen Additional Indications . Amgen shall develop Dmab for any Amgen Additional Indication(s) then under development by Amgen in the Territory in accordance with the then-current development plan approved by the Development Committee for such indications. Amgen’s responsibility with respect to Amgen Additional Indications in the Territory shall include: (a) filing for and seeking Regulatory Approval in the name of Amgen from the relevant Governmental Authorities; (b) investigating additional indications for which Dmab will be developed; (c) identifying and carrying out all major development tasks to be conducted prior to submission of filings for Regulatory Approval for Dmab for a particular indication and any post-approval activities to be conducted for any such indication; (d) identifying key development objectives, expected associated resources, risk factors, timelines, decision points and relevant decision criteria; (e) carrying out all aspects of all clinical trials necessary to obtain Regulatory Approval in the name of Amgen for each indication pursued (including post-approval clinical studies) including, but not limited to, (i) designing study protocols; (ii) establishing/contracting with clinical trial sites, investigators and clinical research organizations, (iii) enrolling clinical trial subjects, (iv) organizing investigator meetings, scientific meetings, advisory panel workshops and regulatory meetings, and (v) analyzing and summarizing clinical trial results; (f) performing any other additional clinical and preclinical research in support of the clinical development of Dmab; (g) forecasting clinical manufacturing production requirements; and (h) reporting on study design, study outcome, other communications and regulatory filings to the appropriate Governmental Authority. Subject to Section 4.18 (Transition in Oncology Development) and Section 8.8 (Development Cost Sharing) Amgen shall be solely responsible for its costs incurred in its development of Dmab in the Territory.

Page 23 of 65

4.6.	Development Outside the Territory . Amgen shall have the sole right to manage and conduct the development of Dmab outside the Territory in all indications. The foregoing is without prejudice to Collaborator’s payment obligations pursuant to Section 8.8 (Development Cost Sharing).

4.7.

Global Development . The Parties acknowledge that it may be in their mutual interests to integrate Collaborator’s development of Dmab within the Territory into Amgen’s global development plan for Dmab for a particular Collaborator Indication. The Parties agree to discuss in good faith where it may be appropriate to so include such development, and the relevant cost-sharing that will be applicable thereto. As requested by either Party, the Parties shall meet and confer in good faith as to the feasibility and potential efficiency gains of cooperating to integrate Collaborator’s development of Dmab for [*] in the Territory into Amgen’s global development plan for such indication. The Parties acknowledge that one ongoing study within Oncology, a study of [*], the “Ongoing Oncology Study” ), currently includes sites both inside and outside the Territory. The Ongoing Oncology Study is a global registration trial intended to support a filing for approval in the United States and Europe, as well as in the Territory. After the Effective Date, the management of those sites shall be addressed as provided in Section 4.18 (Transition in Oncology Development), and shall be conducted strictly in accordance with Amgen’s global procedures and protocol for such trial, as in effect at the relevant time, as communicated by Amgen to Collaborator (and/or any relevant contract research organization). If Amgen elects to [*] that would be likely to [*] in the Territory, the Parties will discuss [*] and will discuss [*] in the Territory.

4.8.

Sharing of Regulatory Filings . Each of the Parties will disclose to the other a draft copy of any Regulatory Filing in the Territory in the original language no less than thirty (30) days prior to filing it with a Governmental Authority. Each Party will consider in good faith any comments made by the other Party with respect to such filings. Each Party shall, no less frequently than quarterly, and more often as reasonably requested by the other Party, provide to the other Party (in such format as reasonably requested) all material preclinical and clinical data arising out of or relating to Dmab in trials thereof in the Territory (and outside the Territory, for Amgen) (or such subset of such data as the Parties may agree). Each of the Parties shall maintain a database which contains all clinical trial data accumulated from all clinical trials of Dmab in the Territory (in a computer readable format reasonably requested by Amgen). Upon the request of either Party, the other Party shall provide a right of reference to any requested Regulatory Filings or Regulatory Approvals in the Territory, and Amgen shall provide the same such right of reference to Collaborator with respect to such Regulatory Filings and Regulatory Approvals outside the Territory, in each case as reasonably necessary for the requesting Party’s development or commercialization of Dmab as permitted hereunder (or, with respect to Amgen, manufacture of Dmab). Notwithstanding the foregoing, Amgen shall not be required to provide to Collaborator nor to allow Collaborator to access (but shall provide a right of reference as set forth in Section 4.15.3 (Amgen Cooperation) to the extent necessary) Amgen’s manufacturing information with respect to Dmab or any sections of any such Regulatory Filing related thereto and neither Party shall have an obligation to provide information relating to any product other than Dmab.

Page 24 of 65

4.9.

Clinical Supply . Collaborator shall obtain its requirements of Dmab for use in clinical development from Amgen, and shall [*] provision of such clinical supply. Amgen shall use reasonably diligent efforts to provide Collaborator with such supply in a form materially the same as the form of clinical supply used by Amgen outside the Territory (i.e. with respect to formulation, presentation, raw materials, diluent and components). Should Collaborator request Amgen to provide clinical supply that materially varies from that used by Amgen outside the Territory, Collaborator and Amgen shall meet to discuss in good faith the best approach with respect to such request. Collaborator shall provide Amgen, at least thirty (30) days prior to the start of each Calendar Quarter, a rolling, one-year forecast for its requirements of clinical Dmab supply. Amgen shall use its reasonable efforts to satisfy such need, and shall promptly notify Collaborator of any difficulty foreseen in doing so. In such event, the Parties shall meet promptly to discuss how to best address such situation.

4.10.

Quality Agreement . Promptly following the Effective Date, the quality assurance departments of Amgen and Collaborator will develop and agree upon a quality agreement governing the quality and specifications of clinical Dmab to be supplied hereunder including with respect to product quality and product complaints (to the extent not covered in a separate safety agreement entered into pursuant to Section 4.13 (Safety Agreement)) with respect to Dmab. The quality agreement will be documented in writing, and routinely updated by mutual written agreement of the Parties.

4.11.

Transfer of Regulatory Filing . Promptly after the Effective Date, Amgen shall transfer to Collaborator all Regulatory Filings in the Territory with respect to Dmab in Collaborator Indications.

4.12.

Transfer of Regulatory Matters . Collaborator shall not transfer title in, fail to maintain or otherwise attempt in any manner to dispose of any Regulatory Filings or Regulatory Approvals or other governmental licenses, approvals or certificates for Dmab in the Territory without the prior written approval of Amgen.

4.13.

Safety Agreement . Promptly following the Effective Date, the safety departments of Amgen and Collaborator will develop and agree upon safety data exchange procedures governing the coordination of collection, investigation, reporting, and exchange of information concerning adverse events with respect to Dmab sufficient to permit each Party, its Affiliates, permitted sublicensees and licensees to comply with Law, including, to the extent applicable, those obligations contained in U.S. Food and Drug Administration (or any successor agency) and MHLW regulations. The safety data exchange procedures will be documented in writing, and promptly updated if required by changes in Law or by agreement of the Parties.

4.14.

Adverse Event Reporting . Each Party shall inform the other Party of any adverse event with respect to Dmab of which it becomes aware in a timely manner commensurate with the seriousness of the adverse event. Each Party shall be responsible for reporting to the MHLW all adverse events with respect to Dmab (whether within or outside the Territory), to the extent required by and in accordance with Law. Each Party will ensure that its Affiliates, permitted sublicensees and licensees, as applicable, comply with all such reporting obligations. Each Party will designate a safety liaison to be responsible for communicating with the other Party regarding the reporting of adverse events with respect to Dmab.

Page 25 of 65

4.15.

Communications .

4.15.1.

Collaborator Responsibility. Collaborator shall have exclusive responsibility for all correspondence and for any official communication (except as Amgen may be required by Law or a Governmental Authority to communicate) regarding Dmab in Collaborator Indications with applicable Governmental Authorities in the Territory (other than with respect to manufacturing). Collaborator will supply to Amgen a copy of: (i) all such correspondence and communications to any such Governmental Authority at least ten (10) business days prior to provision of such correspondence or communication to such Governmental Authority (or as promptly as possible where exigent circumstances make such provision impractical); and (ii) all such correspondence and communications from any such Governmental Authority within (10) business days of receipt of any such correspondence. Collaborator shall consider in good faith any comments or suggestions made by Amgen with respect to any such communication. Amgen shall reasonably cooperate with Collaborator in responding to any inquiry made by a Governmental Authority in the Territory regarding Dmab in Collaborator Indications, and Collaborator shall reimburse all reasonable, documented, out-of-pocket expenses incurred by Amgen in connection therewith. Amgen shall be entitled to observe and participate in any discussions between Collaborator and any Governmental Authority, and Collaborator shall give Amgen ten (10) business days prior written notice thereof (or prompt written notice, if ten (10) business days notice is impractical). Should Collaborator be unable to solicit Amgen’s participation in any such discussion (as, for example, with respect to a call or visit to Collaborator by such Governmental Authority without notice), then Collaborator shall provide Amgen prompt written notice of such communication with a summary of the discussion.

4.15.2.

Amgen Responsibility. Amgen shall have exclusive responsibility for all correspondence and for any official communication (except as Collaborator may be required by Law or a Governmental Authority to communicate) regarding Dmab in Amgen Additional Indications with applicable Governmental Authorities in the Territory and with applicable Governmental Authorities in all indications outside the Territory. Amgen shall have exclusive responsibility for all correspondence and for any official communication with Government Authorities in and outside the Territory regarding manufacture of Dmab. With respect to the Territory, Amgen will supply to Collaborator a copy of: (i) all such correspondence and communications (other than those related to manufacturing or relating to Amgen proprietary manufacturing information) to any such Governmental Authority at least ten (10) business days prior to provision of such correspondence or communication to such Governmental Authority (or as promptly as possible where exigent circumstances make such provision impractical); and (ii) all such correspondence and communications (other than those related to manufacturing or relating to Amgen proprietary manufacturing information) from any such Governmental Authority within (10)

Page 26 of 65

business days of receipt of any such correspondence. Amgen shall consider in good faith any comments or suggestions made by Collaborator with respect to any such communication. Collaborator shall be entitled to observe and participate in any discussions between Amgen and any Governmental Authority in the Territory (other than those related to manufacturing or to Amgen proprietary manufacturing information), and Amgen shall give Collaborator ten (10) business days prior written notice thereof (or prompt written notice, if ten (10) business days notice is impractical). Should Amgen be unable to solicit Collaborator’s participation in any such discussion (as, for example, with respect to a call or visit to Amgen by such Governmental Authority without notice), then Amgen shall provide

SITE SEARCH

AGREEMENTS / CONTRACTS

CLAUSES

Search Contract Clauses >>

Browse Contract Clause Library>>

Get Email Updates