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Collaboration and Option Agreement

Collaboration Agreement

Collaboration and Option Agreement | Document Parties: Amgen Inc | Cytokinetics, Incorporated You are currently viewing:
This Collaboration Agreement involves

Amgen Inc | Cytokinetics, Incorporated

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Title: Collaboration and Option Agreement
Governing Law: California     Date: 3/12/2007
Law Firm: Wilson Sonsini    

Collaboration and Option Agreement, Parties: amgen inc , cytokinetics  incorporated
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Exhibit 10.63

Collaboration and Option Agreement

between

Amgen Inc.

and

Cytokinetics, Incorporated

dated

December 29, 2006

 

 

 

Collaboration and Option Agreement

     This Collaboration and Option Agreement (this "Agreement" ) is entered into as of the 29th day of December, 2006 (the "Effective Date" ) by and between Cytokinetics, Incorporated, a Delaware corporation ( "CK" ) and Amgen Inc., a Delaware corporation ( "Amgen" ). CK and Amgen are sometimes referred to herein, individually, as a "Party" or, collectively, as "Parties."

      WHEREAS, CK is a leading biopharmaceutical company focused on the discovery, development and commercialization of novel small molecule drugs that specifically target the cytoskeleton;

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

      WHEREAS, CK has developed proprietary technologies and intellectual property relating to the Collaboration (as defined below);

      WHEREAS, CK has conducted research into, and has developed expertise in, the cell biology related to cardiac muscle contractility;

      WHEREAS, CK is developing CK-452 (as defined below) for the potential treatment of heart failure;

      WHEREAS, CK intends to conduct the Research Program (as defined below) to develop back-up and follow-on molecules to CK-452, and to better characterize the actin-myosin interaction in cardiac muscle;

      WHEREAS, Amgen may wish to perform similar research in coordination with CK and the Research Plan;

      WHEREAS, Amgen desires to obtain a non-exclusive license in the Field in the Territory to certain of CK’s intellectual property and proprietary rights related to cardiac muscle contractility;

      WHEREAS, Amgen desires to obtain an exclusive right to obtain an exclusive license in the Field in the Territory (as defined below) to research, develop, manufacture and commercialize CK-452 and other Compounds (as defined below); and

      WHEREAS, contemporaneous with the execution of this Agreement, the Parties are entering into a stock purchase agreement whereby CK shall sell to Amgen equity securities of CK.

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

1. Definitions

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, "control" shall mean: (i) in the case of any corporate entity, direct or indirect ownership of fifty percent (50%) or more (or, if less than fifty percent (50%), the maximum ownership interest permitted by applicable Law) 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 fifty percent (50%) or more (or, if less than fifty percent (50%), the maximum ownership interest permitted by applicable Law) of the equity or income interest therein.

1.2.

 

"Amgen Joint Patent Rights" shall mean Amgen’s (or its Affiliates’) interest in any and all Patent Rights jointly owned by Amgen or its Affiliate, on the one hand, and CK or its Affiliate, on the other, to the extent they claim: (i) the composition, formulation, manufacture or use of Research Eligible Compounds; or (ii) any method of treatment involving modulation of the contractile elements of cardiac muscle tissue to activate cardiac contractility; in each case, that arise out of the performance of the Collaboration.

 

   

1.3.

 

"Alliance Manager" shall have the meaning set forth in Section 2.1.

1.4.

 

"Amgen Patent Rights" shall mean any and all Patent Rights Controlled by Amgen or its Affiliates on or after the Effective Date to the extent they claim: (i) the composition, formulation, manufacture or use of Research Eligible Compounds; or (ii) any method of treatment involving modulation of the contractile elements of cardiac muscle tissue to activate cardiac contractility; in each case, that arise out of the performance of the Collaboration.

1.5.

 

"Amgen Option" shall mean Amgen’s exclusive option to obtain the license set forth in Section 9.1.2 on the terms and conditions set forth herein, as more fully described in Article 10 below, and other rights as expressly set forth herein.

1.6.

 

"Change of Control" shall mean, with respect to a Party, the occurrence of any of the following events: (i) any corporation or other person or entity is or becomes the "beneficial owner" (as such term is used in sections 12(d) and 13(d) of the Securities Exchange Act of 1934, as amended, except that a corporation or other entity shall be deemed to have "beneficial ownership" of all shares that any such corporation or other entity has the right to acquire, whether such right may be exercised immediately or only after the passage of time), of a majority of the total voting power represented by all classes of capital stock then outstanding of such Party normally entitled to vote in elections of directors of the Party; (ii) such Party consolidates with or merges into another corporation or entity, or any corporation or

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entity consolidates with or merges into such Party, other than: (A) a merger or consolidation which would result in the voting securities of such Party outstanding immediately prior to such merger or consolidation continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity or any parent thereof) a majority of the combined voting power of the voting securities of such Party or such surviving entity or any parent thereof outstanding immediately after such merger or consolidation; or (B) a merger or consolidation effected to implement a recapitalization of such Party (or similar transaction) in which no corporation or other person or entity becomes the beneficial owner, directly or indirectly, of voting securities of such Party representing a majority of the combined voting power of such Party’s then outstanding securities; and (iii) such Party conveys, transfers or leases all or substantially all of its assets to any corporation or other entity other than a wholly-owned subsidiary of such Party in one or more related transactions.

 

   

1.7.

 

" [ *** ] Compound" shall mean a Compound that is: (i) [ *** ] pursuant to the [ *** ] , or is [ *** ] , for [ *** ] (e.g., [ *** ] or [ *** ] ) [ *** ] , [ *** ] or [ *** ] ; or (ii) [ *** ] at the relevant time, subsequent to the Amgen Option Effective Date, [ *** ] Compound.

 

   

1.8.

 

"CK- [ *** ] " shall mean the Compound designated by CK as CK- [ *** ] .

 

   

1.9.

 

"CK-452" shall mean the Compound designated by CK as CK-1827452, and the subject of clinical development by CK as of the Effective Date pursuant to IND number [ *** ] .

 

   

1.10.

 

"CK Intellectual Property" shall mean all intellectual property or proprietary rights Controlled by CK or its Affiliates on or after the Effective Date and necessary or useful in the conduct of the Collaboration, and CK’s (or its Affiliates’) interest in any such intellectual property or proprietary right jointly owned by Amgen or its Affiliate, on the one hand, and CK or its Affiliate on the other. The CK Intellectual Property includes the CK Patent Rights.

 

   

1.11.

 

"CK Joint Patent Rights" shall mean CK’s (or its Affiliates’) interest in any Patent Rights jointly owned by Amgen or its Affiliate, on the one hand, and CK or its Affiliate on the other.

 

   

1.12.

 

" CK Market Segment " shall mean: (i) [ *** ] , (ii) [ *** ] and (iii) [ *** ] .

 

   

1.13.

 

"CK Patent Rights" shall mean: (i) any and all Patent Rights Controlled by CK or its Affiliates on or after the Effective Date in the Territory to the extent they claim (x) the composition, formulation, manufacture or use of a Compound; or (y) any method of treatment involving modulation of the contractile elements of cardiac muscle tissue to activate cardiac contractility, including, without limitation, those set forth on Schedule 1.13; and (ii) the CK Joint Patent Rights.

*** Certain information on this page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted portions.

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1.14.

 

"Clinical Trial" shall mean a Phase I Trial, Phase IIa Trial, Phase IIb Trial or Phase III Trial.

1.15.

 

"Co-Chair" shall mean a co-chairperson of the applicable Committee appointed by one of the Parties pursuant to Article 2.

1.16.

 

"Co-Invest Option" shall mean CK’s option to increase its participation with respect to a Compound, and to increase its potential royalties for that Compound and to co-promote that Compound, as detailed more fully in Article 11.

1.17.

 

"Collaboration" shall mean the activities undertaken hereunder by the Parties, including the research, development, manufacture and commercialization of Compounds.

1.18.

 

"Collaboration Patent Rights" shall mean the Joint Patent Rights, Amgen Patent Rights and CK Patent Rights.

1.19.

 

"Commercialization Plan" shall mean the plan adopted by the JCC in accordance with Section 2.13.3 for commercialization of Compounds, including a budget for the work to be provided therein.

1.20.

 

"Committee" shall mean one of the Joint Steering Committee, Joint Commercialization Committee, Joint Development Committee and Joint Research Committee.

1.21.

 

"Compound" shall mean any chemical or molecular entity, however formulated, that [ *** ] and that, as a [ *** ] of such Compound (as [ *** ] ), [ *** ] and shall include any [ *** ] . Compound shall include, inter alia, CK-452 and CK- [ *** ] .

1.22.

 

"Compound Criteria" shall mean: (i) those criteria set forth in Exhibit 1.22, and (ii) such other or modified criteria as are approved by the JRC and agreed in writing by the Parties. No criteria shall be deemed Compound Criteria under (ii) unless such criteria are formally approved by the JRC and agreed in writing by the Parties, regardless of whether such criteria are used informally or discussed by the Parties in the course of the Research Program.

1.23.

 

"Control" with respect to any intellectual property or proprietary right shall mean ownership or the possession of the legal authority or right of a Party hereto (or any of its Affiliates) to grant a license or sublicense of such property or right to the other Party, or to otherwise disclose proprietary or trade secret information to the other Party, without breaching the terms of any agreement with a Third Party, or misappropriating the intellectual property or proprietary right or trade secret information of a Third Party.

*** Certain information on this page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted portions.

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1.24.

 

" [ *** ] " shall mean any of the following [ *** ] : (i) any [ *** ] with respect to the [ *** ] of any Compound in [ *** ] including a [ *** ] concerning whether or not to [ *** ] of any Compound; (ii) the [ *** ] of [ *** ] of a Compound; (iii) [ *** ] for a Compound; (iv) [ *** ] a Compound; or (v) [ *** ] (which are expected to [ *** ] ).

1.25.

 

"Development Plan" shall mean the plan adopted by the JDC in accordance with Section 2.12 for the conduct of the Development Program, including, from and after the Amgen Option Effective Date, a budget for the work to be provided therein. The initial Development Plan (consisting of a detailed [ *** ] development plan for CK-452 and summary plans for [ *** ] for CK-452 for the [ *** ] following the Effective Date is attached hereto as Schedule 1.25).

1.26.

 

"Development Program" shall mean the program of pharmaceutical development for the Compounds in the Field in the Territory to be carried out pursuant to this Agreement and, in particular, Article 4 hereof. The Development Program shall, prior to the Amgen Option Effective Date, include the activities set forth on Schedule 10.2.1 and shall include activities reasonably intended to provide the data called for in such schedule.

1.27.

 

"E.U. Marketing Approval" shall mean a Marketing Approval sufficient for the promotion and sale of a product in [ *** ] of the following: [ *** ] .

1.28.

 

" Extended Research Term " shall mean the period commencing on the second anniversary of the Effective Date until the earlier of (i) the expiration of the Amgen Option; (ii) termination of this Agreement, or (iii) the Amgen Option Effective Date.

1.29.

 

"FDA" shall mean the United States Food and Drug Administration, or any successor entity thereto.

1.30.

 

"Field" shall mean any and all uses for the treatment, diagnosis, prevention or prophylaxis of any disease or condition in humans.

1.31.

 

"First Commercial Sale" shall mean the first sale in the Territory to a Third Party of a Compound by or under the authority of Amgen or its Affiliate after receipt of the applicable Marketing Approval.

1.32.

 

"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) of work on or directly related to the Collaboration). Overtime, 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. No one person shall be permitted to account for more than one FTE in a given twelve month period.

*** Certain information on this page has been omitted and filed separately with the Commission.
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1.33.

 

" [ *** ] Co-Invest" shall mean, with respect to a particular Compound, for CK to exercise its Co-Invest Option [ *** ] for such Compound.

1.34.

 

"GAAP" shall mean then-current generally accepted accounting principles in the United States as established by the Financial Accounting Standards Board or any successor entity or other entity generally recognized as having the right to establish such principles, in each case consistently applied.

1.35.

 

" Global Registration Dossier " shall mean, with respect to a particular Compound being developed under the Collaboration, the collective data package from clinical and other studies specifically applicable to obtaining, maintaining and expanding regulatory approvals for such Compound throughout the United States and European Union, excluding country-specific requirements.

1.36.

 

"GLP Toxicology Studies" shall mean, with respect to a Compound, the animal toxicology studies conducted in accordance with cGLP that are a necessary prerequisite for and intended to support the filing of an IND for such Compound in the United States.

1.37.

 

"IND" shall mean, with respect to the United States, an investigational new drug application filed with the FDA as more fully defined in 21 C.F.R. §312.3 or, with respect to a jurisdiction other than the United States, an equivalent filing with the applicable Regulatory Authority for purposes of obtaining permission to Initiate human clinical testing in such jurisdiction.

1.38.

 

"Initial Research Plan" shall mean the plan attached as Exhibit 1.38 hereto.

1.39.

 

"Initial Research Term" shall mean the period from the Effective Date until the sooner to occur of: (i) the two (2) year anniversary thereof; and (ii) the Amgen Option Effective Date.

1.40.

 

"Initiation" of a clinical trial or to "Initiate" a clinical trial shall mean the first dosing of a human subject in such trial.

1.41.

 

"Joint Commercialization Committee" or "JCC" shall mean the committee formed by the Parties pursuant to Section 2.13 to oversee the commercialization activities to be conducted with respect to Compounds in the Field in the Territory hereunder.

1.42.

 

"Joint Development Committee" or "JDC" shall mean the committee formed by the Parties pursuant to Section 2.12 to oversee the Development Program in the Field in the Territory hereunder.

1.43.

 

"Joint Patent Rights" shall mean the Amgen Joint Patent Rights and the CK Joint Patent Rights.

1.44.

 

"Joint Research Committee" or "JRC" shall mean the committee formed by the Parties pursuant to Section 2.11 to oversee the Research Program to be conducted in the Field in the Territory hereunder.

*** Certain information on this page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted portions.

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1.45.

 

"Law" shall mean, individually and collectively, any and all laws, ordinances, rules, directives and regulations of any kind whatsoever of any governmental or Regulatory Authority within the applicable jurisdiction.

 

   

1.46.

 

[Intentionally omitted.]

1.47.

 

"Marketing Approval" shall mean with respect to any Compound in any regulatory jurisdiction in the Territory, approval from the applicable Regulatory Authority sufficient for the promotion and sale of the Compound in such jurisdiction in accordance with applicable Laws.

1.48.

 

"Net Sales" shall mean with respect to a given period, the [ *** ] during such period, less [ *** ] :

1.48.1.

 

[ *** ] ;

 

   

1.48.2.

 

[ *** ] ;

 

   

1.48.3.

 

[ *** ] ;

 

   

1.48.4.

 

[ *** ] ;

 

   

1.48.5.

 

[ *** ] ;

 

   

1.48.6.

 

[ *** ] ; and

 

   

1.48.7.

 

[ *** ] ;

in each case, as applicable to sales of such Compound: (i) [ *** ] the Territory; or (ii) [ *** ] (a) [ *** ] of this Agreement, or (b) [ *** ] the Territory.

1.49.

 

" [ *** ] Compound" shall mean any Compound that is: (i) [ *** ] pursuant to the [ *** ] , or is [ *** ] , for [ *** ] , [ *** ] or [ *** ] ; or (ii) [ *** ] at the relevant time, subsequent to the Amgen Option Effective Date, to be [ *** ] other than [ *** ] (e.g., [ *** ] or [ *** ] ) [ *** ] , [ *** ] or [ *** ] and which is being so [ *** ]. Every Compound shall be a [ *** ] Compound [ *** ] .

1.50.

 

"Patent Right" shall mean any of the following, whether existing now or in the future anywhere in the Territory: (i) any issued patent, including without limitation inventor’s certificates, utility model, substitutions, extensions, confirmations, reissues, re-examination, renewal or any like governmental grant for protection of inventions; and (ii) any pending application for any of the foregoing, including

*** Certain information on this page has been omitted and filed separately with the Commission.
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without limitation any continuation, divisional, substitution, additions, continuations-in-part, provisional and converted provisional applications.

1.51.

 

"Phase I Trial," "Phase IIa Trial," "Phase IIb Trial" and "Phase III Trial" shall have the following meanings:

 

   

1.51.1.

 

"Phase I Trial" shall mean, with respect to the United States, any human clinical trial, the principal purpose of which is preliminary determination of safety in healthy individuals or patients as described under 21 C.F.R. §312.21(a), or, with respect to a jurisdiction other than the United States, a similar clinical study.

 

   

1.51.2.

 

"Phase IIa Trial" shall mean, with respect to the United States, any human clinical trial conducted in patients with the disease or condition of interest for the purpose of studying the pharmacokinetic or pharmacodynamic properties and preliminary assessment of safety of the drug being studied over a measured dose response range as described under 21 C.F.R. §312.21(b), or, with respect to a jurisdiction other than the United States, a similar clinical study.

 

   

1.51.3.

 

"Phase IIb Trial" shall mean, with respect to the United States, any human clinical trial conducted in the specific patient population with the disease or condition of interest intended to be studied in Phase III for the purposes of preliminary assessment of safety and efficacy, and selection of the dose regimen(s) to be studied in a Phase III Trial, as described under 21 C.F.R. §312.21(b), and that if the defined end-points are met, is sufficient to allow the Initiation of a Phase III Trial, or, with respect to a jurisdiction other than the United States, a similar clinical study.

 

   

1.51.4.

 

"Phase III Trial" shall mean, with respect to the United States, any human clinical trial, that, if the defined end-points are met, is intended to be a pivotal trial for obtaining Marketing Approval or to otherwise establish safety and efficacy in patients with the indication being studied for purposes of filing for Marketing Approval with the FDA as described under 21 C.F.R. §312.21(c), or, with respect to a jurisdiction other than the United States, a similar clinical study.

 

   

1.52.

 

"Plan" shall mean the Research Plan, Development Plan, or Commercialization Plan.

 

   

1.53.

 

"Program" shall mean the program to research, develop, manufacture and commercialize Compounds as set forth herein and in the Plans.

 

   

1.54.

 

" [ *** ] " shall mean that certain technology Controlled by CK or its Affiliates and known internally at CK as " [ *** ] ", consisting of a [ *** ] of [ *** ] technologies to interrogate the potential of [ *** ] to yield [ *** ] that [ *** ] .

 

   

1.55.

 

" [ *** ] " shall mean, with respect to a Party, the [ *** ] by or on behalf of such Party of [ *** ] of [ *** ] , [ *** ] and [ *** ] to discover, research, develop, manufacture and commercialize (as applicable) a Compound [ *** ] in pursuing the discovery, research, development, manufacture and commercialization of

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[ *** ] of [ *** ] of [ *** ] and [ *** ] , but in no event less than [ *** ] and [ *** ] to [ *** ] of [ *** ] of [*** ] and [ *** ] . For clarity, it is understood that [ *** ] shall be evaluated as to the [ *** ] as a [ *** ] based on [ *** ] and may change over time, but shall not take into account: (i) any [ *** ] ; (ii) the [ *** ] such Party to the other Party pursuant to this Agreement; or (iii) such Party’s [ *** ] hereunder in accordance with the [ *** ] .

1.56.

 

"Regulatory Authority" shall mean any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the research, development, manufacture, commercialization or other use (including the granting of Marketing Approvals) of any Compound in any jurisdiction, including the FDA and European Medicines Evaluation Agency.

1.57.

 

"Research Eligible Compounds" shall mean Compounds: (i) determined by the JRC to [ *** ] ; and (ii) if such Compound is [ *** ] by [*** ] for [ *** ] in the Collaboration, that [ *** ] for research hereunder.

1.58.

 

"Research Plan" shall mean the research plan established in accordance with Section 2.11 for the conduct of the Research Program, which shall include, from and after the Amgen Option Effective Date, a budget for the work to be provided therein. The Initial Research Plan shall consist of the plan established by [ *** ] (as of the Effective Date) for [ *** ] to the research of Compounds (and [ *** ] Third Parties), and is attached as Exhibit 1.58 hereto.

1.59.

 

"Research Program" shall mean the program of research to be carried out pursuant to this Agreement and, in particular, Article 3 hereof.

1.60.

 

"Royalty Term" shall mean, with respect to a Compound, on a country-by-country basis, that period from the First Commercial Sale of such Compound following Marketing Approval in such country until the [ *** ] : (i) the [ *** ] ; and (ii) such time as the [ *** ] .

*** Certain information on this page has been omitted and filed separately with the Commission.
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1.61.

 

" [ *** ] " shall mean [ *** ] of the activities and [ *** ] , each as described in [ *** ] .

1.62.

 

"Share Purchase Agreement" shall mean that certain Common Stock Purchase Agreement entered into by the Parties of even date herewith, whereby CK shall sell, and Amgen shall purchase, common stock of CK.

 

   

1.63.

 

"Territory" shall mean the world, with the exception of Japan.

1.64.

 

"Third Party" shall mean any person or entity other than one of the Parties, or an Affiliate of a Party.

1.65.

 

"United States" or "U.S." shall mean the United States of America, its possessions, protectorates, territories and Puerto Rico.

1.66.

 

"Valid Claim" shall mean a claim of an issued and unexpired patent or patent application included in the Collaboration Patent Rights, which claim has not been revoked or held invalid or unenforceable by a court or other government agency of competent jurisdiction and has not been held or admitted to be invalid or unenforceable through re-examination or disclaimer, reissue, opposition procedure, nullity suit or otherwise. [ *** ] if a [***] within the CK Patent Rights, CK Joint Patent Rights, Amgen Patent Rights or Amgen Joint Patent Rights [ *** ] from which such [ *** ] of this Agreement [ *** ] (from and after which [ *** ] subject to the [ *** ] ). With respect to a [ *** ] , the phrase to "infringe a Valid Claim" shall mean to engage in activity that would infringe such claim if it were contained in an issued patent.

1.67.

 

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

" Acquired Party "

 

18.7

" Acquiror "

 

18.7

"Agreement"

 

Preamble

"Alliance Manager"

 

2.1

" Amgen "

 

Preamble

"Amgen Controlled Territories"

 

9.4

" [ *** ] "

 

10.2.1.

"Amgen Indemnitees"

 

17.1

"Amgen Option Effective Date"

 

19.1.1

" [ *** ] "

 

8.8

"Breach Notice"

 

18.5

"Bundle"

 

13.4.3.2

"CK Indemnitees"

 

17.1

"CK Option Notice Date"

 

11.1



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Definition

 

Section

" CK Product Opportunity "

 

4.6.1.3

" CK "

 

Preamble

"Claims"

 

17.1

"Commercial Operating Team"

 

5.2

" [ *** ] "

 

2.9

"Confidential Information"

 

14.1

" [ *** ] "

 

10.2.1

"CREATE Act"

 

8.7

"Defending Party"

 

8.8

"Development Plan"

 

4.1

"Development Project Team"

 

4.2

" [ *** ] "

 

2.9

"DOJ"

 

19.1.5.1

" [ *** ] Milestones "

 

13.3.2

"Effective Date"

 

Preamble

"Federal Court"

 

21.11

"FTC"

 

19.1.5.2

"Governmental Authority"

 

19.1.5.3

" Guiding Principles "

 

2.3

"HSR Act"

 

19.1.5.4

"HSR Clearance Date"

 

19.1.5.5

"Indemnified Party"

 

17.2

"Indemnifying Party"

 

17.2

" [ *** ] Compound"

 

9.2.3

" [ *** ] "

 

13.7

"Joint Steering Committee" or "JSC"

 

2.10.1

" [ *** ] "

 

8.8

"Losses"

 

17.1

"Maintenance Period"

 

10.5

"New Affiliates"

 

2.9

"No Adequate Remedies"

 

18.5

"Notifying Party"

 

2.9

"Party" or "Parties"

 

Preamble

"Patent Subcommittee"

 

8.2

" Paying Party "

 

13.15.2

"Prior Agreement"

 

14.3

" Publishing Party "

 

14.4

" [ *** ] Notice"

 

10.2.4

"Recoveries"

 

8.11

"Research Term"

 

3.3

" Reviewing Party "

 

14.4

" Security Agreement"

 

20



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Definition

 

Section

"SPCs"

 

8.14

"State Court"

 

21.11

"Subcommittee"

 

2.14

"Subject Transaction"

 

2.9

"Taxes"

 

13.15.1

" Term "

 

18.1

"VAT"

 

13.15.1

"Wind-Down Period"

 

18.3.2



2. Governance and Oversight

2.1.

 

Alliance Manager . Each Party will appoint one senior representative who possesses a general understanding of clinical, regulatory, manufacturing and marketing issues to act as its respective alliance manager under the Collaboration (each, an "Alliance Manager" ). Promptly following the Effective Date, each Party will notify the other Party of the name and contact information of its initial Alliance Manager. Either Party may replace its Alliance Manager at any time upon written notice to the other Party. Either Alliance Manager may designate a substitute to temporarily perform the functions of that Alliance Manager. Each Alliance Manager shall be charged with creating and maintaining a collaborative work environment within and among the Committees. Each Alliance Manager will also be responsible for: (i) coordinating the relevant functional representatives of the Parties, in developing and executing Plans; and (ii) providing a single point of communication for seeking consensus both internally within the respective Party’s organizations and together regarding key elements of each Plan. The Alliance Managers shall be entitled to attend meetings of any Committee, but shall not have, or be deemed to have, any rights or responsibilities of a member of any Committee. Each Alliance Manager may bring any matter to the attention of any Committee where such Alliance Manager reasonably believes that such matter requires such attention.

2.2.

 

Plans . The timing to establish all Plans (and associated budgets) shall be consistent with the internal requirements for each Party’s planning and budgeting cycles and shall be finalized no later than [ *** ] of each year (subject to change based on changes to the Party’s planning periods). Each Plan shall be updated at least annually and provide for [***] ([***]) [***] of detailed activities with [***] ([***]) [***] of general guidance; provided that the existing Plan shall continue to govern until updated by the applicable Committee.

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2.3.

 

Guiding Principles . Each Party shall make its decisions and conduct its obligations under the Collaboration in a manner in its good faith determination to be consistent with and in accordance with the "Guiding Principles" set forth in Exhibit 2.3 (the " Guiding Principles "), consistent with its obligations pursuant to Section 2.4.

2.4.

 

Conduct of the Collaboration . Subject to the terms and conditions of this Agreement: (i) prior to the Amgen Option Effective Date, [ *** ] to conduct the Research Program and the Development Program; and (ii) subsequent to the Amgen Option Effective Date, [ *** ] to research, develop, manufacture and commercialize Compounds in the Territory in the Field in accordance with this Agreement (subject to Section [ *** ] hereof). Amgen shall have no obligation pursuant to this Section unless and until the occurrence of the Amgen Option Effective Date.

2.5.

 

Activities in Competition with the Collaboration . Except as otherwise provided in Section 2.9, and Section 18.8.4, other than through the Collaboration in accordance with the Plans, neither Party nor its Affiliates shall research, develop, manufacture or commercialize Compounds, itself or through a Third Party, in the Territory during the term of this Agreement, except as the Parties otherwise expressly agree in writing.

2.6.

 

[ *** ] Activities . Notwithstanding Section 2.5, [ *** ] shall have the right to [ *** ] the Territory and to [ *** ] Compounds (or [ *** ] Compounds), in each case solely for the purpose of supporting the [ *** ] the Territory, subject to [ *** ] , as to: (i) the [ *** ] and; (ii) the [ *** ] Compounds ( [ *** ] ).

2.7.

 

Other . There shall be no restriction under this Agreement on either Party’s research, development or commercialization activities, except as expressly set forth herein. Accordingly, subject to the confidentiality obligations set forth in Article 14, nothing herein shall prevent either Party from using generally applicable information or technology generated in the performance of the Collaboration for internal research as follows: (i) for general technology development purposes, including the discovery, research and development of assay, informatics or other technologies, in each case with general applicability, (ii) to inform structure activity relationships (SAR) for chemical or molecular entities in other programs, [ *** ] to limit the possibility of chemistry overlap with Compounds in the Collaboration or otherwise, or (iii) to generate specificity data, including negative controls and information with respect thereto, in each case of (i) – (iii) outside the Collaboration.

2.8.

 

Acknowledgement . Each of the Parties acknowledges that the other Party has ongoing research, development and/or commercialization activities and, except as expressly set forth herein, such activities are outside the scope of this Agreement and the Collaboration and such activities are not prohibited by Section 2.5.

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2.9.

 

Post-Effective Date Affiliates . In the event that either Party enters into any transaction (a "Subject Transaction" ) after the Effective Date with a Third Party whereby a Third Party becomes an Affiliate of such Party and such Third Party is [ *** ] (a " [ *** ] " ), then such Party (the "Notifying Party" ) shall provide notice to the other Party, within [ *** ] ( [ *** ] ) [ *** ] of the closing of the Subject Transaction, specifying the identity of the Affiliate and describing in reasonable detail, to the extent permitted by Law and without disclosing any proprietary information, [ *** ] and [ *** ] . Any Third Party that so becomes an Affiliate of the Notifying Party by reason of the Subject Transaction are referred to below, collectively, as the "New Affiliates" . Such notice shall include a notification as to whether the Notifying Party intends to: (i) [ *** ] , in which case, where CK is the Notifying Party [ *** ] or, in the case where Amgen is the Notifying Party, the [ *** ] hereunder, and in each case any [ *** ] (to the extent [ *** ] hereunder; (ii) [ *** ] , in which case the Notifying Party shall [ *** ] (including [ *** ] (and vice-versa), and [ *** ] and vice-versa) and use [ *** ] to [ *** ] . In the foregoing case, the Notifying Party and its Affiliates shall [ *** ] to [ *** ] either Party’s efforts under the Collaboration [ *** ] ; (iii) [ *** ] , in which case the Notifying Party shall [ *** ] within [ *** ] ( [ *** ] ) [ *** ] of the closing of the Subject Transaction, during which period the Notifying Party shall [ *** ] (including [ *** ] (and vice-versa), and [ *** ] and vice-versa); in the foregoing case, the Notifying Party and its Affiliates shall [ *** ] to [ *** ] either Party’s efforts under the Collaboration [ *** ] . Notwithstanding the foregoing, (x) where such Subject Transaction is undertaken by Amgen, Amgen may [ *** ] , effective [ *** ] ( [ *** ] ) [ *** ] after provision of such notice; or (y) where such Subject Transaction is undertaken by CK, CK may [ *** ] , effective [ *** ] ( [ *** ] ) [ *** ] after provision of such notice. In the event such Party selects option (ii) and, despite the Notifying Party’s [ *** ] , [ *** ] to [ *** ] such [ *** ] within [ *** ] of

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the closing of the Subject Transaction, then such Party shall be deemed to have [ *** ] , effective as of such [ *** ] . In the case of [ *** ] , Section [ *** ] shall not apply to the [ *** ] by the New Affiliate and the [ *** ] , provided, however that the Party that entered into the Subject Transaction shall not utilize [ *** ] to benefit the [ *** ] . For purposes of this Section 2.9, " [ *** ] " shall mean, with respect to any [ *** ] the [ *** ] ( [ *** ] ) or [ *** ] of [ *** ] or a [ *** ] (in which case the above provisions shall apply to the [ *** ] ) of the [ *** ] , including [ *** ] thereto, to [ *** ] , without the [ *** ] (other than [ *** ] ) [ *** ] by the Notifying Party in such [ *** ] .

2.10.

 

Joint Steering Committee .

 

   

2.10.1.

 

Membership . The Collaboration shall be overseen by a joint steering committee (the "Joint Steering Committee" or "JSC" ) consisting of the [ *** ] or the [ *** ] of Amgen and the [ *** ] of Cytokinetics. The initial members are set forth on Schedule 2.10.1.

2.10.2.

 

Decision Making . The JSC shall decide issues by [ *** ] , provided, that, after the Amgen Option Effective Date, in the event [ *** ] .

2.10.3.

 

Responsibilities . The JSC shall be responsible for: (i) [ *** ] to the Collaboration; (ii) providing a [ *** ] ; (iii) [ *** ] of the Compounds in accordance with the [ *** ] ; (iv) [ *** ] , and (v) undertaking and/or approving such other matters as are specifically provided for the JSC under this Agreement.

2.10.4.

 

Meetings . The JSC shall meet annually, or more frequently as the members thereof may agree, in person or via telephone or videoconference, to discuss the progress of the Collaboration as a whole, and any issue with respect to the Collaboration as desired by either member thereof. Other than the members thereof, no personnel of any Party and no Third Party shall be entitled to attend such meetings without the JSC’s consent.

 

   

2.11.

 

Joint Research Committee .

2.11.1.

 

Membership . The JRC shall be established as soon as practical subsequent to the Effective Date and shall be comprised of three (3) members appointed by CK and three (3) members appointed by Amgen, or such other equal number of members appointed by each of the Parties as the Parties may agree. All members appointed by each of the Parties shall be [ *** ] . The initial appointees for the

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JRC are set forth on Schedule 2.11.1. In addition, each Party’s Co-Chair shall be a [ *** ] . Each Party shall appoint one of the members appointed by it as a Co-Chair. At least one member appointed by each Party shall have the breadth of responsibilities necessary to assert decision-making authority and oversight such that the JRC may make the appropriate decisions within the scope of its responsibility.

 

   

2.11.2.

 

Decision Making . Decisions of the JRC shall be made by [ *** ] of the members present in person or by other means (e.g., teleconference) at any meeting, with [ *** ] and the Parties shall endeavor in good faith to [ *** ] with respect to matters appropriately before the JRC. In order to make any decision the JRC must have present (in person or telephonically) at least one representative of each Party.

 

   

2.11.3.

 

Initial Meeting . Promptly after January 1, 2007, the JRC shall meet to discuss and review the Initial Research Plan and determine appropriate modifications thereto including the [ *** ] hereunder consistent with the objectives for research hereunder set forth in the Initial Research Plan. The JRC shall endeavor to [ *** ] and [ *** ] . For clarity, unless the Parties otherwise agree, all such activities performed by a Party shall be at such Party’s expense. As of the Effective Date, the Parties anticipate that the JRC will [ *** ] . In the event that the Research Plan [ *** ] , the [ *** ] of the Research Plan may be [ *** ] .

 

   

2.11.4.

 

Responsibilities . The JRC shall be responsible for: (i) deciding and establishing the objectives and direction for the Research Program; (ii) modifying and updating the Research Plan, and adopting an annual detailed Research Plan for the upcoming year, including for the Extended Research Term and including [ *** ] ; (iii) reviewing, discussing and updating the [ *** ] ; (iv) reviewing and monitoring the [ *** ] ; (v) communicating with the [ *** ] of Compounds; (vi) providing such information as requested by [ *** ] activities with respect thereto; (vii) [ *** ] ; (viii) undertaking and/or approving such other matters as are specifically provided for the JRC under this Agreement; (ix) otherwise providing a forum for the exchange of scientific information among the scientists participating in the Research Program; and (x) communicating to the Parties regarding all of the foregoing.

 

   

2.11.5.

 

Meetings . The JRC shall meet quarterly during each year in person or as otherwise agreed by the Parties. Any in-person meetings shall be held on an alternating basis between CK’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

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appropriate, other employee representatives of the Parties may attend JRC meetings as nonvoting observers, 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 [ *** ] ( [ *** ] ) [ *** ] notice to the Co-Chair appointed by the other Party. At its meetings, the JRC shall discuss the progress of the Parties in executing the Research Program and any other matters pertaining to the Research Program.

 

   

2.11.6.

 

Reporting . Each Party shall keep the JRC fully and promptly informed of progress and results of research activities for which it is responsible or which it is permitted to conduct under the Collaboration through its members on the JRC and as otherwise provided herein. Each Party shall fully inform the JRC of all relevant facts and activities with respect to any research matter reasonably requested by any member thereof. At least [ *** ] ( [ *** ] ) [ *** ] prior to each regularly scheduled JRC meeting, each Party shall deliver to the JRC a written summary of research activities conducted hereunder by each such Party since the last such report.

 

   

2.12.

 

Joint Development Committee .

 

   

2.12.1.

 

Membership . The JDC shall be established as soon as practical subsequent to the Effective Date and shall be comprised of three (3) members appointed by CK and three (3) members appointed by Amgen, or such other equal number of members appointed by each of the Parties as the Parties may agree. All members appointed by each of the Parties shall be [ *** ] . The initial appointees for the JDC are set forth on Schedule 2.12.1. In addition, each Party’s Co-Chair shall be a [ *** ] . Each Party shall appoint one of the members appointed by it as a Co-Chair. At least one member appointed by each Party shall have the breadth of responsibilities necessary to assert decision-making authority and oversight such that the JDC may make the appropriate decisions within the scope of its responsibility.

 

   

2.12.2.

 

Decision Making . Prior to the Amgen Option Effective Date, the JDC shall constitute a consultative, information sharing and advisory body and shall not have decision-making authority. During this time, [ *** ] with respect to the Development Program and Development Plan. Subsequent to the Amgen Option Effective Date, the JDC shall be a decision-making body with respect to the Development Program. Decisions of the JDC shall be made by [ *** ] of the members present in person or by other means (e.g., teleconference) at any meeting, with [ *** ] , and the Parties shall endeavor in good faith to [ *** ] with respect to matters appropriately before the JDC. In order to make any decision the JDC must have present (in person or telephonically) at least one representative of each Party. [ *** ] . Notwithstanding anything to the contrary, [ *** ] shall not have the

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right to [ *** ] except as expressly agreed by [ *** ] in writing.

 

   

2.12.3.

 

Responsibilities .

 

2.12.3.1.

 

Pre-Exercise. Prior to the Amgen Option Effective Date, the JDC shall be responsible for: (i) providing a [ *** ] of such development; (ii) ensuring the [ *** ] relating to the development activities being conducted hereunder; (iii) reviewing [ *** ] ; and (iv) providing a [ *** ] relating to development of Compounds generally.

 

     

 

2.12.3.2.

 

Post-Exercise. Subsequent to the Amgen Option Effective Date, in addition to the responsibilities set forth in Section 2.12.3.1, the JDC shall be responsible for: (i) amending or modifying the Development Plan, and adopting an annual detailed Development Plan for the upcoming year; (ii) reviewing and monitoring [ *** ] ; (iii) communicating with the [ *** ] ; (iv) establishing the [ *** ] as necessary for the [ *** ] ; (v) [ *** ] hereunder; (vi) [***]; (vii), monitoring and reporting [ *** ] ; (viii) [ *** ] relating to the Development Program; (ix) undertaking and/or approving such other matters as are specifically provided for the JDC under this Agreement, including those set forth in Schedule 2.12.3.2; and (x) communicating to the Parties regarding all of the foregoing.

2.12.4.

 

Meetings . The JDC shall meet quarterly during each year in person or telephonically, or as otherwise agreed by the Parties. Any in-person meetings shall be held on an alternating basis between CK’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 JDC meetings as nonvoting observers, 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 [ *** ] ( [ *** ] ) [ *** ] notice to the Co-Chair appointed by the other Party. At its meetings, the JDC shall discuss the

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progress of the Parties in executing the Development Program and the status of and potential for Amgen exercising the Amgen Option.

 

   

2.12.5.

 

Reporting . Each Party shall keep the JDC fully and promptly informed of progress and results of development activities for which it is responsible or permitted to conduct hereunder through its members on the JDC and as otherwise provided herein, including by promptly providing copies of all clinical data and results (in no event later than [ *** ] ( [ *** ] ) [ *** ] after such information becomes available to the relevant Party). Each Party shall fully inform the JDC with respect to all relevant facts and activities with respect to any development matter reasonably requested by any member thereof. At least [ *** ] ( [ *** ] ) [ *** ] prior to each JDC meeting, each Party shall deliver to the JDC a written summary of development activities conducted hereunder by each such Party since the last such report.

 

   

2.13.

 

Joint Commercialization Committee .

 

   

2.13.1.

 

Membership . The JCC shall be formed within [ *** ] ( [ *** ] ) [ *** ] after the [ *** ] . The JCC shall be comprised of three (3) members appointed by CK and three (3) members appointed by Amgen, or such other equal number of members appointed by each of the Parties as the Parties may agree. All members appointed by each of the Parties shall be [ *** ] . In addition, each Party’s Co-Chair shall be a [ *** ] . Each Party shall appoint one of the members appointed by it as a Co-Chair. At least one member appointed by each Party shall have the breadth of responsibilities necessary to assert decision-making authority and oversight such that the JCC may make the appropriate decisions within the scope of its responsibility.

 

   

2.13.2.

 

Decision Making . Decisions of the JCC shall be made by [ *** ] of the members present in person or by other means (e.g., teleconference) at any meeting, with [ *** ] , and the Parties shall endeavor in good faith to [ *** ] with respect to matters appropriately before the JCC. In order to make any decision the JCC must have present (in person or telephonically) at least one representative of each Party. [ *** ] . [ *** ] shall not have the right to [ *** ] except as expressly set forth in Article 5 and as otherwise agreed by [ *** ] in writing.

 

   

2.13.3.

 

Responsibilities . The JCC shall be responsible for: (i) adopting an initial Commercialization Plan for each Compound at such time as determined by the JCC, amending or modifying the Commercialization Plan, and adopting an annual detailed Commercialization Plan for the upcoming year, in each case consistent with the description set forth on Schedule 2.13.3A; (ii) reviewing, coordinating and ensuring [ *** ] ; (iii) communicating with the [ *** ] ; (iv) [ *** ] (v) reviewing and monitoring the [ *** ] ; (vi) monitoring and reporting [ *** ] ;

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(vii) developing the [ *** ] of Compounds; (viii) [ *** ] ; (ix) undertaking and/or approving such other matters as are specifically provided for the JCC under this Agreement, including those set forth on Schedule 2.13.3B; and (x) communicating to the Parties regarding all of the foregoing. When determining the foregoing, the JCC shall give consideration to [ *** ] performing commercialization activities. Notwithstanding the foregoing, the JCC shall have no obligation to [ *** ] except as set forth in Section [ *** ] .

 

   

2.13.4.

 

Meetings . The JCC shall meet quarterly during each year in person or telephonically, or as otherwise agreed by the Parties. Any in-person meetings shall be held on an alternating basis between CK’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 JCC meetings as nonvoting observers, 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 [ *** ] ( [ *** ] ) [ *** ] notice to the Co-Chair appointed by the other Party. At its meetings, the JCC shall discuss the progress of the Parties in executing the Commercialization Plan and any other matters pertaining to commercialization conducted hereunder.

 

   

2.13.5.

 

Reporting . Each Party shall keep the JCC informed of progress and results of commercialization activities for which it is responsible under the Collaboration through its members on the JCC and as otherwise provided herein. At least [ *** ] ( [ *** ] ) [ *** ] prior to each JCC meeting, each Party shall deliver to the JCC a written summary of commercialization activities conducted hereunder by each such Party since the last such report.

 

   

2.14.

 

Subcommittees . From time to time, the JRC, JDC or JCC may establish subcommittees to oversee particular projects or activities, and such subcommittees shall be constituted as such Committee approves (each, a "Subcommittee" ). If any Subcommittee is unable to reach a decision on any matter after endeavoring for [ *** ] ( [ *** ] ) [ *** ] to do so, such matter shall be referred to the applicable Committee that established such Subcommittee for resolution.

 

   

2.15.

 

Replacement of Committee 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

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a replacement by written notice to the other Party. Any replacement member (or Co-Chair) shall be subject to the requirements for such member as described in this Article 2, provided, however, that if a Party nominates a replacement member that does not meet such criteria, the other Party shall consider the relevant qualifications and experience of such proposed replacement.

2.16.

 

Input from other Personnel . Any Committee member shall have the right to solicit input or assistance from any other personnel of the relevant Party.

 

   

2.17.

 

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.

 

   

2.18.

 

Exigent Circumstances . Notwithstanding anything in this Article 2 to the contrary, each of the Parties shall have the right to take prompt action within the scope of their rights hereunder where exigent circumstances so require, without the necessity for Committee review. In any such case, such Party shall promptly notify the Committee of such action and the exigent circumstances.

 

   

2.19.

 

Japan . Notwithstanding anything to the contrary, the Committees shall have no authority to govern activities conducted for purposes outside the Territory and expressly permitted hereunder.

 

   

3.

 

Joint Research Program

 

   

3.1.

 

Research Plan . The JRC shall establish, update and approve annually an integrated work plan and budget that defines each Party’s responsibilities and contribution of resources under the Research Program. The Initial Research Plan shall be in effect until the JRC agrees to modify such Initial Research Plan in accordance with Section 2.11.4.

 

   

3.2.

 

Conduct of the Research Program Prior to Amgen Option Exercise . During the Initial Research Term, CK shall conduct the Research Program in accordance with the Research Plan at CK’s sole cost and expense except as expressly provided herein. CK shall use [ *** ] to perform such research in accordance with the then-current Research Plan. CK’s intellectual property or proprietary rights developed in the course of such research shall be included in the definition of CK Intellectual Property. As currently contemplated by the Parties, the focus of the Research Program shall be as described in the Initial Research Plan, and CK shall perform activities thereunder towards meeting the objectives set forth therein, as such may be modified based on allocation of responsibilities and activities between the Parties as established by the JRC. Notwithstanding the foregoing, the JRC shall have the right to tailor the Research Program to take into account the best avenue for advancing such program at a given time taking into account the information available to it at such time. Amgen shall have the right to request CK to conduct additional research activities at Amgen’s cost, and CK shall consider such requests in good-faith and, if CK so agrees, shall perform such activities. Prior to the Amgen Option Effective Date, Amgen shall conduct research

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activities with respect to Compounds, including with respect to the activities set forth above, solely in accordance with the Research Plan or as otherwise approved by the JRC, provided, however that the JRC shall have no right to assign any research activities to Amgen except as expressly agreed by Amgen in writing. Amgen and CK shall coordinate through the JRC any such research activity so conducted by Amgen with the research conducted by CK. Amgen shall conduct such research at its sole cost and expense, and any intellectual property or proprietary rights developed in the course of such research shall be owned by Amgen, but such rights shall be included in the Collaboration, to the extent and as provided in Section 9.2. CK shall provide Amgen with any reasonable assistance and materials requested by Amgen to enable it to conduct such research, and Amgen shall reimburse CK any reasonable, out-of-pocket costs incurred by CK in connection with such cooperation.

 

   

3.3.

 

Conduct of the Research Program Subsequent to Amgen Option Exercise . Subsequent to the Amgen Option Effective Date the Parties shall conduct research in accordance with the then-current Research Plan for a period of [ *** ] (such period from the Amgen Option Effective Date until the conclusion thereof, the "Research Term") . The JRC shall consult and develop a plan to ensure the continuity of the research efforts then being undertaken as and to the extent necessary to maximize continuing progress of the Research Plan. The JRC shall have the right to tailor the Research Program to take into account the best avenue for advancing each Program at a given time taking into account the information available to the JRC at such time. The JRC shall allocate responsibility for the various aspects of the Research Plan to the Parties provided, however, that the JRC shall not allocate more than [ *** ] ( [ *** ] ) FTEs of research responsibility per year to CK without CK’s prior written consent. Each Party agrees to allocate those FTEs as reasonably necessary to progress and complete the tasks assigned to it in the then-current Research Plan on the timeframes as set forth therein (as currently contemplated, to potentially include [ *** ] ), but no less than the number of FTEs set forth for such Party in the then-current Research Plan on a task-by-task basis (subject to any changes necessary due to unexpected progress and/or setbacks). From and after the Amgen Option Effective Date, Amgen shall be responsible for the direct, reasonable out-of-pocket costs incurred by the Parties in accordance with the Research Plan, including the Third Party costs for any activities specified to be outsourced in the Research Plan. In addition, Amgen shall support [ *** ] CK FTEs [ *** ] and provided in accordance with the Research Plan by CK at the FTE Rate, payable in accordance with Section 13.6. With the prior consent of the JRC, CK shall have the right to provide additional FTEs to the Research Program [ *** ] .

 

   

3.4.

 

Provision of [ *** ] . Promptly following the Effective Date, the Parties shall [ *** ] , for a [ *** ] of no less than [ *** ] ( [ *** ] ) [ *** ] , for [ *** ] to [ *** ] from [ *** ] for [ *** ] to discover Compounds for research, development, manufacture and commercialization in the Territory pursuant to this Agreement,

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subject to [ *** ] relating thereto. It is contemplated that such [ *** ] , and for [ *** ] to [ *** ] for research, development, manufacture and commercialization by the Collaboration [ *** ] . Each [ *** ] for research, development, manufacture and commercialization to the Collaboration by [ *** ] shall be a [***] if it [***]. If [ *** ] or if [ *** ] , [ *** ] shall be [ *** ] , subject to the provisions of Section [ *** ] .

 

   

3.5.

 

Extended Research Term . Within [ *** ] ( [ *** ] ) [ *** ] following the initiation of the Extended Research Term, the JRC shall meet and establish a Research Plan that sets forth responsibilities of the Parties for the continuation of the Research Program during the Extended Research Term. The responsibilities of the Parties shall be allocated in a manner consistent with the prior responsibilities of the Parties, provided, however that the JRC shall have no right to allocate any activities to a Party except as expressly agreed by such Party in writing.

 

   

4.

 

Joint Development Program

4.1.

 

Development Plan . The JDC shall establish, update and approve annually an integrated work plan and budget that defines each Party’s responsibilities and contribution of resources under the Development Program, including for creating and maintaining the Global Registration Dossier (the "Development Plan" ). For clarity, the Development Plan shall encompass and govern the activities of the Parties in the Field across the Territory.

 

   

4.2.

 

Development Project Team . The Parties will establish a project team for each Compound (the "Development Project Team" ) that will be responsible for managing, reviewing and implementing the performance of the day to day activities of both Parties for all stages of the Development Program for such Compound, including review and decision making regarding CMC, toxicology, clinical trial designs and regulatory filings and strategy. Each Party will have representation on the Development Project Team throughout the Development Program, and the Development Project Team shall be subordinate to and governed by the JDC.

 

   

4.3.

 

Manufacturing Subcommittee . Promptly after the Amgen Option Effective Date, the Parties shall establish a manufacturing subcommittee to manage, oversee, facilitate and coordinate the transfer of manufacturing information and protocols by, and transition manufacturing from, CK to Amgen. Each Party will have representation on the Manufacturing Subcommittee throughout the Development Program, and the Manufacturing Subcommittee shall be subordinate to and governed by the JDC.

 

   

4.4.

 

Regulatory Subcommittee . The Parties shall establish a regulatory subcommittee that will be responsible for coordinating activities regarding regulatory matters as charged by the JDC. Each Party will have representation on the Regulatory Sub-

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committee throughout the Development Program, and the Regulatory Sub-committee shall be subordinate to and governed by the JDC.

4.5.

 

Conduct of the Development Program Prior to Amgen Option Exercise . Prior to the Amgen Option Effective Date, CK shall conduct a development program designed to pursue the clinical development of Compounds in accordance with the Development Plan. CK shall use [ *** ] to perform such development in accordance with the then-current Development Plan and to undertake the activities and [ *** ] in a manner [ *** ] . As currently contemplated by the Parties, the initial focus of the Development Program with respect to CK-452 shall be: (i) the [ *** ] , and the [ *** ] ; and (ii) the conduct of the activities and [ *** ] . Notwithstanding the foregoing, CK shall have the right to control and tailor the Development Program to take into account the best avenue for advancing the Development Program at a given time taking into account the information available to it at such time. For clarity, prior to the Amgen Option Effective Date, Amgen shall not perform any development activities directed toward CK-452 or any other Compound unless otherwise expressly agreed by the Parties.

 

   

4.6.

 

Conduct of the Development Program Subsequent to Amgen Option Exercise . Subsequent to the Amgen Option Effective Date, the JDC shall regularly evaluate Compounds that are the subject of the Research Program to determine which Compounds, if any, shall be developed by the Parties hereunder.

 

   

4.6.1.

 

Development Responsibilities .

 

4.6.1.1.

 

[ *** ] Development . Subsequent to the Amgen Option Effective Date, but prior to the [ *** ] for a Compound, the JDC shall delegate operational responsibility for all clinical trials and all other development activities for such Compound to CK or Amgen, while in any event [ *** ] in the area. It is the intent of the Parties that the JDC shall [ *** ] , unless the JDC determines that [ *** ] (as, for example, [ *** ] ).

 

     

 

4.6.1.2.

 

[ *** ] Development . Subsequent to the Amgen Option Effective Date and the [ *** ] for a Compound, the JDC shall [ *** ] .

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The JDC shall [ *** ] related to such development. The JDC shall assign to CK primary responsibility for the operational aspects of [ *** ] for such Compound. If [ *** ] is anticipated to be conducted, significant [ *** ] shall be assigned by the JDC to CK.

 

     

 

4.6.1.3.

 

CK Product Opportunities . If CK, through its participation on the JDC, identifies a development and commercialization opportunity that arises in consideration of the Development Program that may fall outside of the then-current Development Plan and that does not [ *** ] , (each such development opportunity, a " CK Product Opportunity ") and [ *** ] and the [ *** ] and [ *** ] hereunder (giving consideration to all relevant factors), then [ *** ] CK perform such activities under a mutually agreed modification to the Development Plan, provided that [ *** ] . If [ *** ] , CK will have responsibility for the development and commercialization of the Compound for the CK Product Opportunity, and all costs associated therewith, and subject to [ *** ] to be agreed in writing prior to such authorization. CK shall apply [ *** ] to conduct the development and commercialization of the Compound for the CK Product Opportunity and communicate regularly to Amgen through its participation on the JDC and JCC as to the plans and progress therefor.

 

     

 

4.6.1.4.

 

CK Preference . Amgen shall [ *** ] utilize CK as its [ *** ] services hereunder, subject to CK [ *** ] for the particular activities and CK’s agreement to perform such activities [ *** ] with [ *** ] for [ *** ] from [ *** ] , including by [ *** ] for development activities [ *** ] . In the event of [ *** ] in good faith.

 

     

 

4.6.1.5.

 

[ *** ] . Subsequent to the Amgen Option Effective Date, and subject to Section 10.4, the Parties shall use

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[ *** ] to conduct development as assigned by the JDC and in accordance with the Development Plan.

4.7.

 

Development Costs .

 

4.7.1.1.

 

Pre-Exercise . Prior to the Amgen Option Effective Date, CK shall be responsible for all costs expended by CK on development.

 

     

 

4.7.1.2.

 

Post-Exercise. Subsequent to the Amgen Option Effective Date, if CK performs development services pursuant to Section 4.6.1.4, then Amgen shall reimburse CK for internal FTEs approved in advance by Amgen at the then agreed FTE rate, payable in accordance with Section 13.6. In addition, Amgen shall bear all Third Party costs for any activities specified to be outsourced pursuant to the Development Plan, provided that such Third Party costs are approved in advance by Amgen.

5.

 

Joint Commercialization Program

 

   

5.1.

 

Commercialization Plan . The JCC shall establish, update and approve annually a plan and budget for commercialization activities for the Compounds hereunder consistent with Schedule 2.13.3A. For clarity, the Commercialization Plan shall encompass and govern the activities of the Parties in the Field across the Territory.

 

   

5.2.

 

Commercial Operating Team . From and after the time [ *** ] , the JCC will establish an operating team for each Compound ( "Commercial Operating Team" ) that will be responsible for managing, reviewing, and implementing the performance of the day to day responsibilities of both Parties for all stages of the commercialization program for such Compound, including review and decision making regarding plans for manufacture, promotion, marketing, sale, distribution, and medical education. [ *** ] the Commercial Operating Team for such Compound throughout the commercialization of such Compound hereunder, and the Commercial Operating Team shall be subordinate to and governed by the JCC.

 

   

5.3.

 

Pre-Option Exercise Activities . Prior to the Amgen Option Effective Date, subject to consultation with Amgen, CK shall have the right to continue its commercialization activities that it has undertaken prior to the Effective Date including [ *** ] . Subsequent to the Amgen Option Effective Date, the Parties shall cooperate through the JCC to coordinate the transition of such activities.

 

   

5.4.

 

Amgen Commercialization . Except as set forth in Section 5.5, subsequent to the Amgen Option Effective Date, Amgen shall have sole responsibility for commercialization of Compounds in the Territory, and shall use [ *** ] to do so in accordance with the Commercialization Plan. Except for those costs to be borne by CK pursuant to Section 5.5.4, Amgen shall bear its

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own internal and out-of-pocket costs incurred with respect to such commercialization activities. In addition, Amgen shall bear all Third Party costs for any activities specified to be outsourced in the Commercialization Plan.

 

   

5.5.

 

Co-Promotion .

5.5.1.

 

Election and Percentage . For Compounds in which CK has [ *** ] Co-Invested, CK shall have the right, but not the obligation, to provide a percentage elected by CK of up to [ *** ] percent ( [ *** ] %) of the details within the CK Market Segment in the U.S., Canada and/or Mexico. To exercise its co-promotion rights for a Compound in which CK has [ *** ] Co-Invested, CK must notify Amgen in writing, within [ *** ] ( [ *** ] ) [ *** ] of the filing of the first application for Marketing Approval in U.S., Mexico or Canada with respect to such Compound and receipt of the Commercialization Plan therefor, of CK’s election to co-promote such Compound and the percentage of the details CK elects to provide within the CK Market Segment (subject to a maximum of [ *** ] percent ( [ *** ] %)). Specific details in the CK Market Segment in the U.S., Canada and Mexico shall be allotted by the JCC, taking into account CK’s interests in developing and maintaining relationships in the CK Market Segment, and product strategy for the relevant Compound. In determining CK’s elected percentage share of the details in the CK Market Segment, details provided pursuant to Section 5.5.3 shall be taken into account.

 

   

5.5.2.

 

Co-Promotion Agreement . At such time as CK has [ *** ] Co-Invested with respect to a particular Compound pursuant to Section 11.1 and makes the election to co-promote such Compound in the U.S., Canada and/or Mexico pursuant to Section 5.5.1, the Parties shall prepare and enter into a definitive agreement specifying in more detail the overall framework for the co-promotion activities of the Parties for such Compound in the U.S., Canada and Mexico, consistent with this Section 5.5, and the Parties shall finalize such agreement as promptly as practical following the filing of an application for Marketing Approval for such Compound. Such agreement shall provide for CK’s sales force responsible for promotion of the Compounds to [ *** ] , and for CK’s sales force to [ *** ] . In addition, such co-promotion agreement shall include provisions for [ *** ] .

 

   

5.5.3.

 

CK Hospitals . For Compounds in which CK has [ *** ] Co-Invested, the [ *** ] as set forth in this Section 5.5.3. With respect to [ *** ] specific hospitals in the U.S., Mexico and Canada ( [ *** ] and [ *** ] ), CK shall have [ *** ] within such hospitals in accordance with the Commercialization Plan for such Compound (even where those [ *** ] the hospital setting). Amgen and CK shall coordinate their efforts subject to oversight by the JCC. Such responsibility shall include [ *** ] to be taken with such [ *** ] , as well as

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coordinating the details and educational programs called for in the Commercialization Plan. All promotional materials, sales aids, monographs, and educational program materials used by CK shall be approved by the JCC to ensure compliance with the Commercialization Plan, consistency between the efforts of the Parties and conformance with compliance standards to be adopted or approved by the JCC and applicable Law. Amgen shall have responsibility for [ *** ] the hospital setting, even where those [ *** ] the hospital setting; for all such [ *** ] , Amgen and CK shall coordinate their efforts subject to oversight by the JCC.

 

   

5.5.4.

 

Payment . Amgen shall pay CK for details performed pursuant to Section 5.5 in accordance with the Commercialization Plan [ *** ] , as agreed by the Parties, provided that the cost to be reimbursed [ *** ] . CK shall bear any other costs associated with its commercialization activities. In addition, should the JCC request CK to undertake additional activities and CK agree to do so, then Amgen shall reimburse CK’s reasonable, out-of-pocket costs and FTE costs at the FTE Rate, in accordance with a budget to be established by the JCC.

 

   

5.5.5.

 

[ *** ] . [ *** ] pursuant to this Article 5 shall be [ *** ] , or [ *** ] necessary to do so in [ *** ] and [ *** ] in such manner.

6.

 

Manufacturing, Sales and Distribution

6.1.

 

Responsibility . Prior to the Amgen Option Effective Date, CK shall be solely responsible for the manufacture of Compounds, provided Amgen shall have the right to manufacture quantities of Compounds as may be required for its own research conducted in accordance with the Research Plan. In addition, CK shall provide to Amgen reasonable quantities of Compounds as requested by Amgen for its research use, and Amgen shall reimburse CK therefor [ *** ] (including [ ***]) as applicable. Subsequent to the Amgen Option Effective Date, Amgen shall be solely responsible for the manufacture, distribution and sale of Compounds in the Territory, provided, however, that CK shall have the right to manufacture Compounds in accordance with Section 2.6. Amgen shall book all sales of Compounds in the Territory.

 

   

6.2.

 

Regulatory Responsibility . Prior to the Amgen Option Effective Date, CK shall be solely responsible for securing and maintaining any regulatory approvals needed in connection with the manufacture of Compounds (except with respect to Compounds manufactured by Amgen for its research). Subsequent to the Amgen Option Effective Date, Amgen shall have the sole responsibility for securing and maintaining any regulatory approvals needed in connection with the manufacture, distribution and sale of Compounds in the Territory (except with respect to Compounds manufactured by or under authority of CK in accordance with Section

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2.6). Subsequent to the Amgen Option Effective Date, all regulatory approvals in the Territory shall be owned by Amgen, and CK shall promptly transfer to Amgen any such approvals held in its name [ *** ] and relevant information, data and protocols to the extent reasonably necessary for Amgen to manufacture Compounds hereunder and on hand API and formulated Compounds (other than those reasonably necessary for CK’s conduct of clinical trials for which it has been assigned operational responsibility by the JCC, or reasonably necessary for CK’s use outside the Territory) to Amgen (and Amgen shall reimburse CK [ *** ] cost with respect to such API and formulated Compounds), and the Parties shall cooperate to ensure a smooth transition of regulatory responsibility. Amgen agrees to reimburse CK’s [ *** ] costs in connection with such transfer. Subject to [ *** ] , CK shall have the right to reference relevant approvals to the extent reasonably necessary for CK to manufacture and supply Compounds in support of its activities outside the Territory in accordance with Section 2.6.

 

   

6.3.

 

Reasonable Cooperation . After the Amgen Option Effective Date, CK shall cooperate reasonably with Amgen in connection with the manufacture, distribution or sale of Compounds in the Field in the Territory, and the regulatory approvals therefor, for which Amgen is responsible under this Agreement, and Amgen shall reimburse CK [ *** ] costs incurred by CK in connection therewith, as well as for time incurred by CK at the FTE Rate. Amgen shall cooperate with CK in connection with the manufacture, distribution or sale of Compounds for use under the Collaboration and to support activities outside the Territory and the regulatory approvals therefor, and CK shall reimburse Amgen [ *** ] costs incurred by Amgen in connection therewith, as well as for time incurred by Amgen at the FTE Rate. Without prejudice to any other provision of this Agreement, the foregoing sentence shall not be deemed to [ *** ] , and [ *** ] . The Parties acknowledge the possible advantage of collaborative sourcing for Compounds, and each Party shall consider in good-faith any request by the other Party to cooperate with respect to such sourcing.

 

   

6.4.

 

Extent of Cooperation . The Parties’ cooperation obligations pursuant to this Article 6 shall not impose upon a Party any obligation to create any data, file any approval or take any action that the Party is not undertaking for its own accord. By way of example, a Party shall share, as described herein, information generated by it in the course of its own activities, but shall have no obligation to generate additional information that may be useful for the other Party, except as expressly set forth herein.

7.

 

Regulatory

 

   

7.1.

 

Regulatory Responsibility .

 

   

7.1.1.

 

Prior to the Amgen Option Effective Date. Prior to the Amgen Option Effective Date, CK shall own and be solely responsible for filing, obtaining and maintaining

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all approvals necessary for the research and development of Compounds; all such approvals shall be held in the name of CK or its designee. CK shall: (i) promptly provide Amgen with copies of any written communication from and a summary of any oral communication with any Regulatory Authority relating to a Compound; (ii) allow Amgen a reasonable opportunity (but in no event less than [ *** ] ( [ *** ] ) [ *** ] ) to review and comment on any submission or correspondence to any Regulatory Authority relating to any Compound; (iii) consider in good-faith any comments made by Amgen pursuant to subsection (ii) or otherwise with respect to interactions with any Regulatory Authority concerning any Compound or activities conducted pursuant to the Collaboration; (iv) allow Amgen to attend any in person meetings with any Regulatory Authority and to listen in on any planned calls with any Regulatory Authority; and (v) otherwise provide Amgen with any reasonably requested information or documentation relating to regulatory submissions or approvals. While CK is responsible for regulatory activities for a Compound pursuant to this Section 7.1.1, Amgen shall not independently communicate with any Regulatory Authority with respect to any such Compounds, except as may be required by Law.

 

   

7.1.2.

 

Subsequent to the Amgen Option Effective Date . Subsequent to the Amgen Option Effective Date, Amgen shall own and be solely responsible for filing, obtaining and maintaining approvals necessary for the development and commercialization of Compounds in the Territory in the Field and any approval for any product labeling or promotional materials in the Territory with respect thereto; and unless otherwise agreed or required by applicable Law, all such approvals shall be held in the name of Amgen or its designee. Within [ *** ] ( [ *** ] ) [ *** ] of the Amgen Option Effective Date, CK shall transfer to Amgen, at [ *** ] , all Marketing Approvals in the Territory held in the name of CK or its designee. CK shall provide Amgen any assistance reasonably requested in connection with any such approval, and Amgen shall reimburse CK [ *** ] costs incurred in connection therewith. Following such transfer, Amgen shall (i) promptly provide CK with copies of any written communication from and a summary of any oral communication with any Regulatory Authority relating to a Compound; (ii) allow CK a reasonable opportunity (but in no event less than [ *** ] ( [ *** ] ) [ *** ] ) to review and comment on any submission or correspondence to any Regulatory Authority relating to any Compound; (iii) consider in good-faith any comments made by CK pursuant to subsection (ii) or otherwise with respect to interactions with any Regulatory Authority concerning any Compound or activities conducted pursuant to the Collaboration; (iv) allow CK to attend any in person meetings with any Regulatory Authority and to listen in on any planned calls with any Regulatory Authority; and (v) otherwise provide CK with any reasonably requested information or documentation relating to regulatory submissions or approvals. While Amgen is responsible for regulatory activities for a Compound pursuant to this Section 7.1.2, CK shall not independently communicate with any Regulatory Authority in the Territory with respect to any such Compounds, except as may be required by Law.

 

   

7.2.

 

Clinical Safety Reporting; Pharmacovigilance . At all times subsequent to the Amgen Option Effective Date, Amgen shall be solely responsible for establishing

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and shall establish operating and other procedures reasonably sufficient to report to the appropriate Regulatory Authority(ies) all adverse event reports, safety reports and similar matters, unless otherwise determined by the JDC in accordance with the Laws in the Territory (and CK outside the Territory). Promptly following the Amgen Option Effective Date, the safety personnel of Amgen and CK 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 Compounds (including with respect to pregnancies), product quality and product complaints involving adverse events with respect to Compounds, sufficient to permit each Party, its Affiliates and licensees to comply with their legal obligations, including to the extent applicable, those obligations contained in FDA regulations. Each Party shall further provide the other Party any assistance reasonably requested by the other Party in connection with safety reporting and fulfilling its obligations to Regulatory Authorities with respect thereto, and the requesting Party shall reimburse the other Party [ *** ] costs incurred in connection therewith.

 

   

7.3.

 

Transfer of Data, Technology and Regulatory Filings . Promptly following the Amgen Option Effective Date, such that such transfer is completed within [ *** ] ( [ *** ] ) [ *** ] of the Amgen Option Effective Date, CK shall deliver to Amgen (or provide copies where CK is required by Law to maintain original records), [ *** ] data, [ *** ] data, [ *** ] data, [ *** ] data and [ *** ] data (including [ *** ] (both [ *** ] and [ *** ] ), [ *** ] , [ *** ] , [ *** ] ) reasonably necessary for Amgen to exercise its rights and perform its obligations under this Agreement with respect to Compounds, and other information pertaining to the Compounds reasonably requested by Amgen, in each case Controlled by CK or its Affiliates, and Amgen shall reimburse CK [ *** ] costs incurred in connection therewith. Each Party shall provide the other with such assistance as the other Party reasonably requests from time to time, to enable such other Party to fully understand and implement the foregoing and the requesting Party shall reimburse the other [ *** ] costs incurred in connection therewith. Without limiting the foregoing, with respect to Confidential Information of a Party, which Confidential Information the other Party desires to include in any regulatory filing, the Party whose Confidential Information it is shall either: (i) make such information available to the other Party or (ii) make such information available directly to the applicable Regulatory Authority (whether by reference or otherwise). In addition, CK (itself or through a designee) shall have the right to reference regulatory filings and data [ *** ] with respect to [ *** ] Compounds for CK’s use [ *** ] for the purposes of development and commercialization of [ *** ] Compounds [ *** ] , subject to [ *** ] of Section [ *** ] . The Parties shall [ *** ] , including [ *** ] and [ *** ] with respect thereto. The Parties will [ *** ] .

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7.4.

 

Use of Contractors . CK ( [ *** ] and [ *** ] ) and Amgen shall each have the right to use the services of Third Party contractors, including contract research organizations, contract manufacturing organizations, contract sales forces and the like, to assist such Party in fulfilling its obligations and exercising its rights under this Agreement, [ *** ] , including [ *** ] and [ *** ] . Each Party shall consider in good faith the possibility of using the other Party’s resources to perform such activities as an alternative to utilizing the services of a subcontractor.

 

   

7.5.

 

Extent of Cooperation . The Parties’ cooperation obligations pursuant to this Article 7 shall not impose upon a Party any obligation to create any data, file any approval or take any action that the Party is not undertaking for its own accord. By way of example, a Party shall share, as described herein, information generated by it in the course of its own activities, but shall have no obligation to generate additional information that may be useful for the other Party, except as expressly set forth herein.

8.

 

Intellectual Property

 

   

8.1.

 

Ownership .

 

   

8.1.1.

 

General. Except to the extent expressly specified to the contrary in this Agreement, including any exclusivity in this Agreement, (i) each Party shall retain and own all right, title, and interest in and to all patent rights, trade secret, proprietary right and other intellectual property rights conceived or created solely by such Party, (ii) the Parties shall jointly own all right, title, and interest in and to all patent rights, trade secret, proprietary right and other intellectual property rights conceived or created jointly by the Parties and, subject to the provisions of this Agreement neither Party shall have any duty to account or obtain the consent of the other Party in order to exploit or license such intellectual property rights, and (iii) inventorship and authorship of any invention or work of authorship conceived or created by either Party, or jointly by the Parties, shall follow the rules of the U.S. Patent and Trademark Office and the Laws of the United States (without reference to any conflict of law principles). Each Party shall ensure that all employees and consultants providing services related to the Compounds executes all documentation necessary to vest ownership of intellectual property in such Party or its Affiliate.

 

   

8.1.2.

 

[ *** ] . All right, title and interest in and to all technology, patent rights, trade secrets and other intellectual property and proprietary rights that are or include a [ *** ] or [ *** ] by CK, or any portion of any of the foregoing, shall, to the extent such [ *** ] or [ *** ] , be exclusively owned by CK. All right, title and interest in and to all technology, patent rights, trade secrets and other

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intellectual property and proprietary rights that are or include a [ *** ] or [ *** ] by Amgen, or any portion of any of the foregoing, shall, to the extent such [ *** ] or [ *** ] , be exclusively owned by Amgen.

8.2.

 

Patent Subcommittee . Promptly following the Effective Date, the JDC shall establish a Subcommittee (the "Patent Subcommittee" ) to oversee, review and coordinate (i) the prosecution, maintenance, defense and enforcement of Patent Rights within the Collaboration Patent Rights and (ii) other Patent Rights-related matters as are specifically provided for the Patent Subcommittee under this Agreement or assigned to it by the JDC. Such Subcommittee shall meet, in-person or telephonically, as frequently as agreed to discuss matters related to such activities. The Patent Subcommittee shall have equal representation from each Party, with each Party selecting a co-chair. Each Party’s representatives on the Patent Subcommittee shall consist essentially of at least one (1) patent attorney having significant experience relating to pharmaceutical Patent Rights, and other individuals as agreed to be appropriate by the Patent Subcommittee. The Patent Subcommittee in consultation with the JDC shall establish practices and procedures for the identification and disclosure of patentable subject matter and the prosecution maintenance of Patent Rights disclosing such subject matter consistent with the terms and conditions of this Article 8. In determining which outside counsel to use pursuant to Sections 8.4 and 8.5, the Patent Subcommittee shall take into account existing relationships and historical knowledge of the relevant matters, in addition to other relevant factors.

 

   

8.3.

 

Cooperation Generally . Subject to control by each Party as more particularly set forth below and decisions of the Patent Subcommittee, the Parties shall cooperate in order to coordinate reasonably the filing, prosecution, maintenance, defense and enforcement of the Collaboration Patent Rights in, and foreign counterparts thereto outside, the Territory, and each Party shall keep the Patent Subcommittee informed with respect to activities that it performs pursuant to this Article 8 or otherwise based upon its activities in connection with this Agreement. Without limiting the foregoing, in any action by a Party in the Territory pursuant to this Article 8, whether or not the non-enforcing Party chooses to participate in the action, the non-enforcing Party will not oppose being joined, and the enforcing Party shall have the right to join the non-enforcing Party, in such enforcement actions as a party plaintiff, and the non-enforcing Party will take such other actions as necessary for standing or to satisfy other requirements to file, pursue or maintain the action, at the enforcing Party’s request and expense, including reasonably providing testimony, documents, and the like.

 

   

8.4.

 

Prosecution and Maintenance – Pre-Option Exercise .

 

   

8.4.1.

 

Prior to the Amgen Option Effective Date, subject to the oversight of the Patent Subcommittee, CK shall control, through outside counsel mutually acceptable to the Parties and directed by CK, the filing for, prosecution and maintenance (including office actions, oppositions and interferences) of CK Patent Rights and Joint Patent

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Rights, at [ *** ] , in consultation with Amgen, as well as filing for any patent term extensions or similar protections therefor. CK shall provide Amgen copies of and an opportunity to review and comment upon the text of the applications relating to CK Patent Rights and Joint Patent Rights [ *** ] ( [ *** ] ) [ *** ] before filing. CK shall provide Amgen with a copy of each application for each such CK Patent Right or Joint Patent Right as filed, together with notice of its filing date and application number. CK shall keep Amgen advised of the status of all material communications, actual and prospective filings or submissions regarding such CK Patent Rights and Joint Patent Rights, and shall give Amgen copies of and an opportunity to review and comment on any such communications, filings and submissions proposed to be sent to any patent office or judicial body. CK shall reasonably consider in good faith Amgen’s comments on the communications, filings and submissions for the CK Patent Rights and Joint Patent Rights. If CK declines to file for, prosecute or maintain (including defending or prosecuting office actions, prosecutions or interferences) any CK Patent Right or Joint Patent Right, it shall give Amgen reasonable notice thereof and thereafter, Amgen may, upon written notice to CK and at Amgen’s sole cost, control the filing for, prosecution and maintenance (including defending or prosecuting office actions, prosecutions or interferences) of such CK Patent Right or Joint Patent Right thereafter in accordance with Section 8.4.2 below. Amgen shall provide CK any cooperation or assistance reasonably requested by CK in connection with the filing, prosecution and maintenance (including defending or prosecuting office actions, prosecutions or interferences) of CK Patent Rights and Joint Patent Rights, and CK shall reimburse Amgen’s [ *** ] expenses incurred in connection therewith. From and after such time as Amgen exercises the Amgen Option, CK Patent Rights and Joint Patent Rights shall be handled as set forth in Section 8.5 below. With respect to CK Patent Rights and Joint Patent Rights, CK shall not [ *** ] without Amgen’s prior written consent, not to be unreasonably withheld or delayed.

8.4.2.

 

Prior to the Amgen Option Effective Date, subject to the oversight of the Patent Subcommittee, Amgen shall control, through outside counsel mutually acceptable to the Parties and directed by Amgen, the filing for, prosecution and maintenance (including defending or prosecuting office actions, oppositions and interferences) of Amgen Patent Rights, at Amgen’s expense, in consultation with CK, as well as filing for any patent term extensions or similar protections therefor. Amgen shall provide CK copies of and an opportunity to review and comment upon the text of the applications relating to Amgen Patent Rights [ *** ] ( [ *** ] ) [ *** ] before filing. Amgen shall provide CK with a copy of each application for such an Amgen Patent Right as filed, together with notice of its filing date and application number. Amgen shall keep CK advised of the status of all material communications, actual and prospective filings or submissions regarding such Amgen Patent Rights, and shall give CK copies of and an opportunity to review and comment on any such communications, filings and submissions proposed to be sent to any patent office or judicial body. Amgen shall reasonably consider in good faith CK’s comments on the communications, filings and submissions for the Amgen Patent Rights. If Amgen declines to file for, prosecute or maintain (including defending or

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prosecuting office actions, prosecutions or interferences) any Amgen Patent Right, it shall give CK reasonable notice thereof and thereafter, CK may, upon written notice to Amgen and at CK’s sole cost, control the filing for, prosecution and maintenance (including defending or prosecuting office actions, prosecutions or interferences) of such Amgen Patent Right thereafter in accordance with Section 8.4.1. CK shall provide Amgen any cooperation or assistance reasonably requested by Amgen in connection with the filing, prosecution and maintenance (including defending or prosecuting office actions, prosecutions or interferences) of Amgen Patent Rights, and Amgen shall reimburse CK’s [ *** ] incurred in connection therewith. From and after the Amgen Option Effective Date, Amgen Patent Rights shall be handled as set forth in Section 8.5 below.

8.5.

 

Prosecution and Maintenance – Post-Option Exercise . Following the Amgen Option Effective Date, subject to the oversight of the Patent Subcommittee, Amgen shall, through outside counsel mutually acceptable to the Parties and directed by Amgen, control the filing for, prosecution and maintenance (including defending or prosecuting office actions, prosecutions or interferences) of Collaboration Patent Rights in the Territory, at Amgen’s expense, in consultation with CK, as well as filing for any patent term extensions or similar protections. Amgen shall provide CK copies of and an opportunity to review and comment upon the text of the applications relating to such Collaboration Patent Rights [ *** ] ( [ *** ] ) [ *** ] before filing. Amgen shall provide CK with a copy of each application for a Collaboration Patent Right as filed, together with notice of its filing date and application number. Amgen shall keep CK advised of the status of all material communications, actual and prospective filings or submissions regarding Collaboration Patent Rights, and shall give CK copies of and an opportunity to review and comment on any such communications, filings and submissions proposed to be sent to any patent office or judicial body. Amgen shall reasonably consider in good faith CK’s comments on the communications, filings and submission for the Collaboration Patent Rights. If Amgen declines to file for, prosecute or maintain (including defending or prosecuting office actions, prosecutions or interferences) any Collaboration Patent Right, it shall give CK reasonable notice thereof and thereafter, CK may, upon written notice to Amgen and at CK’s sole cost, control the filing for, prosecution and maintenance of such Collaboration Patent Right thereafter in accordance with Section 8.4.1 above. CK shall provide Amgen any cooperation or assistance reasonably requested by Amgen in connection with such filing, prosecution and maintenance (including defending or prosecuting office actions, prosecutions or interferences), and Amgen shall reimburse CK’s [ *** ] expenses incurred in connection therewith.

 

   

8.6.

 

Patent Files . Within [ *** ] ( [ *** ] ) [ *** ] after the Amgen Option Effective Date or [ *** ] , CK shall (to the extent not previously provided) (i) provide Amgen, at [ *** ] ( [ *** ] ), with copies of all documents (including file histories and then current dockets) for the

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applicable CK Patent Rights in the Territory that are in the file maintained by CK’s outside patent counsel for such CK Patent Rights or otherwise available to CK, including any communications, filings and drafts as well as written notice of any pending deadlines or communications for such CK Patent Rights in the Field in the Territory (provided, however, that CK shall provide notice of pending deadlines as promptly as possible after the Amgen Option Effective Date so as to ensure adequate time and coordination with respect to such deadlines), and (ii) execute and deliver any legal papers reasonably requested by Amgen to effectuate transfer of control of the


 
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