Collaboration and Option Agreement

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

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.

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.

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.

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.

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.

[***];

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

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

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 [***].

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:

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.

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.

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

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

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

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

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

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 [***];

(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

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