Common use of Specific Responsibilities of the JDC Clause in Contracts

Specific Responsibilities of the JDC. In addition to its general responsibilities, the JDC shall in particular: (i) Manage and oversee the preparation and implementation of the Development Plan; (ii) Review, discuss and approve non-material amendments to the Development Plan; (iii) Every [***] months, review, discuss, amend, update and submit to the JSC for approval: the Development Plan (subject to Section 3.6), including the Joint Development Budget, the TPP, and any material amendments thereto; review and discuss proposals for new Development Activities pursuant to Section 3.5 and seek input from the JCC; (iv) Decide upon which Party will be responsible for the performance of the various activities set forth in the Development Plan on the basis of each Party’s respective experience, capabilities and capacity as set forth in Section 3.11, including which Party will be the Sponsor of a new Global Trial that is a Joint Development Activity; (v) Oversee the conduct and progress of all Trials required as set forth in the Development Plan, including compliance with Laws and applicable GLP, GCP and/or GMP standards, mitigation actions, e.g. clinical Trial liaison activities and medical scientific activities, in order to improve Trial recruitment and Trial site engagement and any Development Activities; (vi) Align with the Medical Affairs function with regards to Early Access Programs and investigator initiated Trials; (vii) Review and discuss the progress of any Sole Funded Development Activity; (viii) Coordinate and facilitate the exchange of information between the Parties under this Agreement regarding the strategy for implementing the Development Activities, including sharing and reviewing of Development Data created pursuant to this Agreement and establishing procedures for the efficient and prompt sharing of information and materials and Know-How reasonably necessary or useful for the Development of the Product in the Territory; (ix) Coordinate and facilitate exchange by both Parties of Regulatory Data and Regulatory Materials in support of filings, facility inspections and Product launch in the Co-Commercialization Territory and the COMPANY Territory; review, discuss and, with respect to Joint Development Activities only, approve the design of the Trial protocols and endpoints; (x) Discuss and agree on the regulatory strategy for filing and maintaining Regulatory Approvals in the Co-Commercialization Territory, in alignment with the JCC; (xi) Review and discuss the regulatory strategy for filing and maintaining Regulatory Approvals in the COMPANY Territory, in alignment with the JCC; (xii) Review and discuss the contents of all submissions to Regulatory Authorities and Governmental Authorities in the Territory for Regulatory Approvals, Regulatory Materials and all necessary filing and registration activities related thereto; (xiii) Discuss and agree on all matters related to the maintenance of each Party’s safety database and the global safety database, as applicable; (xiv) Review, discuss and oversee issues regarding pharmacovigilance and safety in both the Co-Commercialization Territory and the COMPANY Territory; (xv) Review and provide comments to the JMC regarding Manufacturing Development Activities and discuss progress and issues concerning Manufacturing Development Activities; (xvi) Review and discuss demand forecasts and timelines of Drug Product for supply of the Development Activities under the Supply Agreement and report such demand forecasts and timelines to the JMC; (xvii) Discuss and agree the publication strategy for Development Data; (xviii) Review and discuss subcontractors (e.g. contract research organizations, and vendors) and collaboration partners for Joint Development Activities (subject to qualification of such subcontractors in accordance with Laws, GMP and GDP), and report the proposed subcontractors to the JSC for approval; decide on thresholds for seeking the other Party’s approval to engage such subcontractors and partners, and decide which Party (or the Parties) negotiates the respective agreements and signs such agreements with such subcontractor, with the other Party’s prior approval; (xix) Review results of subcontracted Joint Development Activities.

Specific Responsibilities of the JDC. In addition to its general responsibilities, the JDC shall shall, subject to the terms of this Agreement, in particular: (ia) Manage discuss, prepare and oversee approve for submission to the preparation JSC any Development Plan, and implementation any amendments to a Development Plan (including, for Collaboration Products, the Development Budget under a Subsequent Development Plan); (b) with respect to Collaboration Products, if any, review and update [**] financial forecasts for Development, including regulatory activities, to ensure actual and anticipated expenditure is within the approved Development Budget for the relevant Calendar Year, and make recommendations to the JSC for approval regarding any variances before such additional expenditure is incurred; (c) create, approve for submission to the JSC, and implement the overall strategy for Development and the design and objectives of the all Clinical Trials and non-clinical studies conducted under each Development Plan; (iid) Reviewadvise the JSC on whether and when to Initiate or discontinue, discuss and approve the conduct of, any Clinical Trial and any non-material amendments to the clinical study under each Development Plan; (iiie) Every [***] months, review, discuss, amend, update and submit to the JSC for approval: the Development Plan (subject to Section 3.6), including the Joint Development Budget, the TPP, and any material amendments thereto; review and discuss proposals for new Development Activities pursuant to Section 3.5 and seek input from the JCC; (iv) Decide upon which Party will be responsible for the performance of the various activities set forth in the Development Plan on the basis of each Party’s respective experience, capabilities and capacity as set forth in Section 3.11, including which Party will be the Sponsor of a new Global Trial that is a Joint Development Activity; (v) Oversee the conduct and progress of all Trials required as set forth in the Development Plan, including compliance with Laws and applicable GLP, GCP and/or GMP standards, mitigation actions, e.g. clinical Trial liaison activities and medical scientific activities, in order to improve Trial recruitment and Trial site engagement and any Development Activities; (vi) Align with the Medical Affairs function with regards to Early Access Programs and investigator initiated Trials; (vii) Review and discuss the progress of any Sole Funded Development Activity; (viii) Coordinate and facilitate the exchange flow of information between the Parties under this Agreement regarding the strategy for implementing the with respect to Development Activities, including sharing and reviewing of Development Data created pursuant to this Agreement and establishing procedures for the efficient and prompt sharing of information and materials and Know-How reasonably necessary or useful for the Development Marketing Authorizations of the Product Collaboration Products in the Territory; (ixf) Coordinate discuss and facilitate exchange by both Parties of Regulatory Data approve for submission to the JSC the overall regulatory and Regulatory Materials in support of filings, facility inspections and Product launch filing strategy for obtaining Marketing Authorization for Collaboration Products in the Co-Commercialization Territory and the COMPANY Territory; review, discuss and, with respect to Joint Development Activities only, approve the design of the Trial protocols for maintaining such Marketing Authorization including post-approval commitments and endpointslife cycle management; (xg) Discuss and agree advise the JSC on the regulatory strategy submission of the NDAs for filing and maintaining Regulatory Approvals in the Co-Commercialization Territory, in alignment with the JCCCollaboration Products; (xih) Review review, coordinate and discuss the regulatory strategy approve for filing and maintaining Regulatory Approvals in the COMPANY Territory, in alignment with the JCC; (xii) Review and discuss the contents of all submissions to Regulatory Authorities and Governmental Authorities in the Territory for Regulatory Approvals, Regulatory Materials and all necessary filing and registration activities related thereto; (xiii) Discuss and agree on all matters related to the maintenance of each Party’s safety database and the global safety database, as applicable; (xiv) Review, discuss and oversee issues regarding pharmacovigilance and safety in both the Co-Commercialization Territory and the COMPANY Territory; (xv) Review and provide comments to the JMC regarding Manufacturing Development Activities and discuss progress and issues concerning Manufacturing Development Activities; (xvi) Review and discuss demand forecasts and timelines of Drug Product for supply of the Development Activities under the Supply Agreement and report such demand forecasts and timelines to the JMC; (xvii) Discuss and agree the publication strategy for Development Data; (xviii) Review and discuss subcontractors (e.g. contract research organizations, and vendors) and collaboration partners for Joint Development Activities (subject to qualification of such subcontractors in accordance with Laws, GMP and GDP), and report the proposed subcontractors submission to the JSC for approvalthe scientific presentation and publication strategy relating to the Collaboration Products in the Territory; decide on thresholds for seeking the other Party’s approval to engage such subcontractors and partners, and decide which Party (or the Parties) negotiates the respective agreements and signs such agreements with such subcontractor, with the other Party’s prior approval;and (xixi) Review results perform such other functions as may be appropriate to further the purposes of subcontracted Joint Development Activitiesthis Agreement, as directed by the JSC or as specified in this Agreement.

Specific Responsibilities of the JDC. In addition to support of its general responsibilitiesresponsibility for overseeing, coordinating and expediting the Development of, and regulatory filings for, the Licensed Product, the JDC shall in particular: shall: (ia) Manage review and, if necessary, amend the Development Plan and oversee Development Budget from time to time, but no less frequently than once per Calendar Year; (b) establish a worldwide strategy for the preparation Development and Regulatory Approval of the Licensed Product, consistent with the applicable Development Plan and Budget; (c) direct and supervise the implementation of the Development Plan; Plan for the Licensed Product; (iid) Review, discuss review and approve non-material amendments to the Development Plan; (iii) Every [***] months, review, discuss, amend, update statistical analysis plans and submit to protocols for all Clinical Studies for the JSC for approval: Licensed Product conducted under the Development Plan (subject to Section 3.6)and, including the Joint Development Budget, the TPP, and any material amendments thereto; review and discuss proposals for new Development Activities pursuant to Section 3.5 and seek input from in consultation with the JCC; (iv) Decide upon which Party will be responsible , Post Approval Studies for the performance of the various activities set forth in the Development Plan on the basis of each Party’s respective experience, capabilities and capacity as set forth in Section 3.11, including which Party will be the Sponsor of a new Global Trial that is a Joint Development Activity; (v) Oversee the conduct and progress of all Trials required as set forth in Licensed Product conducted under the Development Plan, including compliance with Laws and applicable GLP, GCP and/or GMP standards, mitigation actions, e.g. clinical Trial liaison activities and medical scientific activities, in order to improve Trial recruitment and Trial site engagement and any Development revisions thereto (in each case other than with respect to Unilateral Activities; ); (vie) Align with the Medical Affairs function with regards to Early Access Programs and investigator initiated Trials; (vii) Review review and discuss the development plan for and execution of any Unilateral Activities; (f) review all proposed Product Labeling; (g) review all proposed Drug Approval Applications and other filings with the Regulatory Authorities with respect to Regulatory Approvals in the Licensee Territory; (h) monitor the progress of any Sole Funded all Clinical Studies and Post Approval Studies for the Licensed Product, including reviewing costs and activities against the Development Activity; Plan and Budget; (viiii) Coordinate and facilitate the exchange of all information between the Parties under this Agreement regarding the strategy for implementing the and data relating to all Clinical Studies, Post Approval Studies and other Development Activities, including sharing and reviewing of Development Data created pursuant to this Agreement and establishing procedures activities for the efficient Licensed Product; (j) consult and prompt sharing of information and materials and Know-How reasonably necessary or useful for coordinate with the JCC to assure a smooth transition from Development to Commercialization of the Licensed Product in the Territory; (ix) Coordinate for each indication and facilitate exchange by both Parties of Regulatory Data and Regulatory Materials in support of filings, facility inspections and Product launch in the Co-Commercialization Territory and the COMPANY Territory; review, discuss and, with respect to Joint Post Approval Studies or the proposed Development Activities only, approve of Additional Indications and lines of therapy for the design Licensed Product; (k) consult with the JCC with respect to such other matters as may have an effect on the Commercialization of the Trial protocols Licensed Product; (l) provide updates on JDC’s activities and endpoints; (x) Discuss and agree on the regulatory strategy for filing and maintaining Regulatory Approvals in the Co-Commercialization Territory, in alignment with the JCC; (xi) Review and discuss the regulatory strategy for filing and maintaining Regulatory Approvals in the COMPANY Territory, in alignment with the JCC; (xii) Review and discuss the contents of all submissions to Regulatory Authorities and Governmental Authorities in the Territory for Regulatory Approvals, Regulatory Materials and all necessary filing and registration activities related thereto; (xiii) Discuss and agree on all matters related achievements to the maintenance JEC no less often than each Calendar Quarter during the term of each Party’s safety database this Agreement; and (m) perform such other functions as are set forth herein or as the global safety databaseParties may mutually agree in writing, as applicable; (xiv) Review, discuss and oversee issues regarding pharmacovigilance and safety except where in both the Co-Commercialization Territory and the COMPANY Territory; (xv) Review and provide comments to the JMC regarding Manufacturing Development Activities and discuss progress and issues concerning Manufacturing Development Activities; (xvi) Review and discuss demand forecasts and timelines conflict with any provision of Drug Product for supply of the Development Activities under the Supply Agreement and report such demand forecasts and timelines to the JMC; (xvii) Discuss and agree the publication strategy for Development Data; (xviii) Review and discuss subcontractors (e.g. contract research organizations, and vendors) and collaboration partners for Joint Development Activities (subject to qualification of such subcontractors in accordance with Laws, GMP and GDP), and report the proposed subcontractors to the JSC for approval; decide on thresholds for seeking the other Party’s approval to engage such subcontractors and partners, and decide which Party (or the Parties) negotiates the respective agreements and signs such agreements with such subcontractor, with the other Party’s prior approval; (xix) Review results of subcontracted Joint Development Activitiesthis Agreement.

Specific Responsibilities of the JDC. In addition to its general responsibilities, the JDC (or the JSC until the JDC is formed, with certain delegations as set forth in this Section 2.3 and Schedule G(a)) shall in particular: (i) Manage and oversee provide regular reports to the preparation and implementation JSC regarding the development of the Product, and discuss, prepare and submit to the JSC for approval annual and interim amendments to the Development PlanPlan (and the Development Budget) for each Product; (ii) Review, discuss and approve non-material amendments to manage the implementation of the Initial Development Plan; (iii) Every [***] months, review, discuss, amend, update and submit to oversee the JSC for approval: the Development Plan (subject to Section 3.6), including the Joint Development Budget, the TPP, and any material amendments thereto; review and discuss proposals for new Development Activities pursuant to Section 3.5 and seek input from the JCCconduct of Development; (iv) Decide upon which Party will be responsible for discuss the performance of audited final report from the various activities set forth in the Development Plan on the basis of each Party’s respective experience, capabilities and capacity as set forth in Section 3.11Carcinogenicity Studies, including which Party will be whether or not a Technical Product Failure has occurred, and provide input thereon to the Sponsor of a new Global Trial that is a Joint Development ActivityJSC; (v) Oversee propose to the conduct and progress of all Trials required as set forth in the Development Plan, including compliance with Laws and applicable GLP, GCP and/or GMP standards, mitigation actions, e.g. clinical Trial liaison activities and medical scientific activities, in order JSC particular studies to improve Trial recruitment and Trial site engagement and any Development Activitiesbe conducted; (vi) Align with create, implement and review the Medical Affairs function with regards to Early Access Programs Development Strategy for Development in the Territory and investigator initiated the design of all Clinical Trials and Nonclinical Studies conducted under each Development Plan, including Phase 4 Clinical Trials; (vii) Review oversee any CMC related development activities, e.g. stability studies or packaging development, as well as other activities to prepare for supply of drug substance and discuss finished Product for Commercialization, including to oversee the progress of any Sole Funded Development Activityselection process for, and select (pursuant to Section 6.4), a contract manufacturer to be used by FibroGen for commercial supplies; (viii) Coordinate decide whether and facilitate the exchange of information between the Parties when to initiate or discontinue any Clinical Trial and any Nonclinical Study under this Agreement regarding the strategy for implementing the each Development ActivitiesPlan, including sharing and reviewing of Development Data created pursuant to this Agreement and establishing procedures for the efficient and prompt sharing of information and materials and Know-How reasonably necessary or useful for the Development of the Product in the TerritoryPhase 4 Clinical Trials; (ix) Coordinate allocate budgeted resources and facilitate exchange by both Parties of Regulatory Data determine priorities for each Clinical Trial and Regulatory Materials in support of filingsNonclinical Study under each Development Plan, facility inspections and Product launch in the Co-Commercialization Territory and the COMPANY Territory; review, discuss and, with respect to Joint Development Activities only, approve the design of the Trial protocols and endpointsincluding Phase 4 Clinical Trials; (x) Discuss oversee the conduct of all Clinical Trials and agree on the regulatory strategy for filing and maintaining Regulatory Approvals in the Co-Commercialization TerritoryNonclinical Studies under each Development Plan, in alignment with the JCCincluding Phase 4 Clinical Trials; (xi) Review and discuss the regulatory strategy for filing and maintaining Regulatory Approvals in the COMPANY Territory, in alignment with the JCCselect Third Party contractors to conduct Clinical Trials of Products; (xii) Review and discuss facilitate the contents flow of all submissions Information between the Parties with respect to Regulatory Authorities and Governmental Authorities in the Territory for Regulatory ApprovalsDevelopment of Products, Regulatory Materials and all necessary filing and registration activities related theretoincluding Development Data [ * ] under this Agreement; (xiii) Discuss discuss whether to Develop Products for other indications and agree on all matters related propose any such indications to the maintenance of each Party’s safety database and the global safety database, as applicableJSC; (xiv) Review, discuss and oversee issues regarding pharmacovigilance and safety in both the Co-Commercialization Territory and the COMPANY Territory; (xv) Review and provide comments to the JMC regarding Manufacturing Development Activities and discuss progress and issues concerning Manufacturing Development Activities; (xvi) Review and discuss demand forecasts and timelines of Drug Product for supply of the Development Activities under the Supply Agreement and report such demand forecasts and timelines to the JMC; (xvii) Discuss and agree the publication strategy for Development Data; (xviii) Review and discuss subcontractors (e.g. contract research organizations, and vendors) and collaboration partners for Joint Development Activities (subject to qualification of such subcontractors in accordance with Laws, GMP and GDP), and report the proposed subcontractors to the JSC for approval; decide on thresholds for seeking the other Party’s approval to engage such subcontractors and partners, and decide which Party (or the Parties) negotiates the respective agreements and signs such agreements with such subcontractor, with the other Party’s prior approval; (xix) Review results of subcontracted Joint Development Activities.

Specific Responsibilities of the JDC. In addition to its general responsibilities, the The JDC shall in particular:, in accordance with the decision-making principles set forth in Section 2.3(c): (i) Manage review Development activities for Licensed Product and oversee Co-Developed Product; (ii) provide a forum for and facilitate communications between the preparation Parties with respect to the Development of Licensed Product and implementation Cancer Product; (iii) facilitate the transfer of Information and materials between the Parties with respect to the Development of Licensed Product and Co-Developed Product (and as needed establish subcommittees to coordinate such transfer); (iv) discuss updates to and progress against the Licensed Field Development Plan; (iiv) Reviewdiscuss updates to the Cancer Development Plan in the case where BMS has not exercised and in the case where BMS does not exercise the Option, in each case to the extent required in Section 3.5; (vi) review proposed Clinical Trials and non-clinical studies in accordance with Section 3.5 and 3.6, and recommend for discussion by the JEC any proposed Clinical Trials and non-clinical studies that may have an Adverse Impact; (vii) review, discuss and approve non-material amendments coordinate the Parties’ scientific presentation and publication plans relating to Licensed Compound and Product, and review any proposed publications pursuant to Section 12.4; (viii) in the case where BMS exercises the Option, with respect to the Co-Developed Product: (1) oversee and monitor the Development of Co-Developed Product in accordance with the Joint Cancer Development Plan; [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (2) discuss, prepare and recommend for approval by the JEC the annual Joint Cancer Development Plan (and the associated Cancer Development Budget) and any interim amendments thereto; (3) discuss and approve any cost overruns incurred for Clinical Trials in excess of the Cancer Development Budget as described in Section 3.7(f); (4) discuss and recommend for JEC approval decision as to whether and when to initiate or discontinue any Clinical Trial and any nonclinical study under the Joint Cancer Development Plan; (iii5) Every discuss the regulatory strategy for Regulatory Approval and oversee regulatory matters in the U.S. and EU for the Co-Developed Product; (6) establish a regulatory subcommittee to review all material regulatory aspects of Development of the Co-Developed Product for the U.S. and EU; (7) review and approve the scientific integrity, statistical analysis plans and protocols (and any investigators’ brochure(s) and revisions thereto) for all Clinical Trials under Joint Cancer Development Plan (it being understood that the JDC may delegate to a working group established by the JDC the review of such matters to avoid inappropriate delay), and reviewing and approving expedited safety reports; (8) review the content, strategies for, and other aspects for the U.S. and EU: product labeling and package insert (including any proposed changes thereto); early access and compassionate use programs; the content of, or any change to the then existing content of, any material regulatory filings; the content of any pharmacovigilance reports; any patient risk management and risk minimization strategies and plans; investigator sponsored clinical studies; and significant post–Approval filings and submissions (including supplements and amendments to Approvals); (9) discuss and develop a regulatory strategy plan for obtaining Approvals in the EU and U.S. and publication strategies for data arising out of co-funded Clinical Trials; (10) make recommendations to the JEC concerning whether to seek new indications for Co-Developed Product; (11) review, coordinate and align Medical Education Activities for the Co-Developed Product; and (12) review, for JCC approval, packaging designs and trademarks (in accordance with Article 10) for the Co-Developed Product; (ix) facilitate the exchange of information in accordance with Section 4.6 in order to ensure that significant issues concerning Adverse Event information and safety issues are addressed consistently and in a timely manner; and (x) perform such other duties as are expressly assigned to the JDC in this Agreement or as may be properly assigned to it by the JEC. [***] months= CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, reviewMARKED BY BRACKETS, discussIS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, amend, update and submit to the JSC for approval: the Development Plan (subject to Section 3.6), including the Joint Development Budget, the TPP, and any material amendments thereto; review and discuss proposals for new Development Activities pursuant to Section 3.5 and seek input from the JCC; (iv) Decide upon which Party will be responsible for the performance of the various activities set forth in the Development Plan on the basis of each Party’s respective experience, capabilities and capacity as set forth in Section 3.11, including which Party will be the Sponsor of a new Global Trial that is a Joint Development Activity; (v) Oversee the conduct and progress of all Trials required as set forth in the Development Plan, including compliance with Laws and applicable GLP, GCP and/or GMP standards, mitigation actions, e.g. clinical Trial liaison activities and medical scientific activities, in order to improve Trial recruitment and Trial site engagement and any Development Activities; (vi) Align with the Medical Affairs function with regards to Early Access Programs and investigator initiated Trials; (vii) Review and discuss the progress of any Sole Funded Development Activity; (viii) Coordinate and facilitate the exchange of information between the Parties under this Agreement regarding the strategy for implementing the Development Activities, including sharing and reviewing of Development Data created pursuant to this Agreement and establishing procedures for the efficient and prompt sharing of information and materials and Know-How reasonably necessary or useful for the Development of the Product in the Territory; (ix) Coordinate and facilitate exchange by both Parties of Regulatory Data and Regulatory Materials in support of filings, facility inspections and Product launch in the Co-Commercialization Territory and the COMPANY Territory; review, discuss and, with respect to Joint Development Activities only, approve the design of the Trial protocols and endpoints; (x) Discuss and agree on the regulatory strategy for filing and maintaining Regulatory Approvals in the Co-Commercialization Territory, in alignment with the JCC; (xi) Review and discuss the regulatory strategy for filing and maintaining Regulatory Approvals in the COMPANY Territory, in alignment with the JCC; (xii) Review and discuss the contents of all submissions to Regulatory Authorities and Governmental Authorities in the Territory for Regulatory Approvals, Regulatory Materials and all necessary filing and registration activities related thereto; (xiii) Discuss and agree on all matters related to the maintenance of each Party’s safety database and the global safety database, as applicable; (xiv) Review, discuss and oversee issues regarding pharmacovigilance and safety in both the Co-Commercialization Territory and the COMPANY Territory; (xv) Review and provide comments to the JMC regarding Manufacturing Development Activities and discuss progress and issues concerning Manufacturing Development Activities; (xvi) Review and discuss demand forecasts and timelines of Drug Product for supply of the Development Activities under the Supply Agreement and report such demand forecasts and timelines to the JMC; (xvii) Discuss and agree the publication strategy for Development Data; (xviii) Review and discuss subcontractors (e.g. contract research organizations, and vendors) and collaboration partners for Joint Development Activities (subject to qualification of such subcontractors in accordance with Laws, GMP and GDP), and report the proposed subcontractors to the JSC for approval; decide on thresholds for seeking the other Party’s approval to engage such subcontractors and partners, and decide which Party (or the Parties) negotiates the respective agreements and signs such agreements with such subcontractor, with the other Party’s prior approval; (xix) Review results of subcontracted Joint Development ActivitiesAS AMENDED.

Specific Responsibilities of the JDC. In addition to its general responsibilities, subject to the terms and conditions of this Agreement, the JDC shall shall, in particular: (ia) Manage and oversee the preparation and implementation of the Development Plan; (ii) Review, discuss and approve non-material amendments to the Development Plan; (iii) Every [***] months, review, discuss, amend, update and submit to the JSC for approval: the Development Plan (subject to Section 3.6), including the Joint Development Budget, the TPP, and any material amendments thereto; review and discuss proposals for new Development Activities pursuant to Section 3.5 and seek input from the JCC; (iv) Decide upon which Party will be responsible for the performance of the various activities set forth in the Development Plan on the basis of each Party’s respective experience, capabilities and capacity as set forth in Section 3.11, including which Party will be the Sponsor of a new Global Trial that is a Joint Development Activity; (v) Oversee the conduct and progress of all Trials required as set forth in the Development Plan, including compliance with Laws and applicable GLP, GCP and/or GMP standards, mitigation actions, e.g. clinical Trial liaison activities and medical scientific activities, in order to improve Trial recruitment and Trial site engagement and any Development Activities; (vi) Align with the Medical Affairs function with regards to Early Access Programs and investigator initiated Trials; (vii) Review and discuss the progress of any Sole Funded Development Activity; (viii) Coordinate and facilitate the exchange of information between the Parties under this Agreement regarding the strategy for implementing Developing the Products; (b) establish one (1) or more plans for data and technology transfers and coordinate and ensure successful completion of the Know-How transfers, as described in Section 2.4 (Technology, Data, and Regulatory Transfer); (c) review and discuss the conduct of all Clinical Trials set forth in the Global Development Plan, as described in Section 4.4 (Development Plans; Unilateral Development Activities; Amendments); (d) at least [**] during the Term (or more or less frequently as may be agreed upon in writing by the Alliance Managers), review, update, and determine whether to approve the updated Global Development Plan and, if applicable, the corresponding Global Development Budget, and submit to the JEC for review and approval any such update that includes Additional Global Development Activities or is otherwise material, as described in Section 4.4.6 (Updating the Global Development Plan); (e) review, discuss, and submit to the JEC to review, discuss, and determine whether to approve each Additional Development Proposal and Combination Therapy Development Proposal, and update the Global Development Plan with any such approved Additional Global Development Activities and Combination Therapy Global Development Activities, including sharing as described in Section 4.4.4 (Additional Development) and reviewing of Development Data created pursuant to this Agreement and establishing procedures for the efficient and prompt sharing of information and materials and Know-How reasonably necessary or useful for the Development of the Product in the TerritorySection 4.8 (Combination Products, Combination Therapies); (ixf) Coordinate review and facilitate exchange by both Parties discuss each Party’s conduct of Regulatory Data and Regulatory Materials in support of filings, facility inspections and Product launch its respective Global Development Activities set forth in the Co-Commercialization Territory Global Development Plan and the COMPANY Territory; review, discuss and, with respect to Joint Development Activities only, approve the design of the Trial protocols and endpointsreview any [**] update reports thereof as described in Section 4.10.2 (Reports); (xg) Discuss and agree on the regulatory strategy for filing and maintaining Regulatory Approvals in the Co-Commercialization Territory, in alignment with the JCC; (xi) Review review and discuss the regulatory strategy for filing Apellis Territory Regional Development Plan and maintaining Regulatory Approvals in the COMPANY TerritorySobi Territory Regional Development Plan, in alignment with the JCC; (xii) Review and discuss the contents of all submissions to Regulatory Authorities and Governmental Authorities in the Territory for Regulatory Approvals, Regulatory Materials and all necessary filing and registration activities related thereto; (xiii) Discuss and agree on all matters related to the maintenance of each Party’s safety database and the global safety database, as applicable; (xiv) Review, discuss conduct and oversee issues regarding pharmacovigilance and safety in both status of the Co-Commercialization Apellis Territory and the COMPANY Territory; (xv) Review and provide comments to the JMC regarding Manufacturing Regional Development Activities and discuss progress and issues concerning Manufacturing Sobi Territory Regional Development Activities; (xvih) Review review, discuss, and discuss demand forecasts approve protocols and timelines of Drug Product statistical analysis plans for supply of the Development Activities Clinical Trials conducted under the Supply Agreement and report such demand forecasts and timelines Global Development Plan pursuant to the JMCSection 4.7 (Clinical Trials); (xviii) Discuss review, discuss, and agree the publication strategy for Development Datacoordinate with each Party’s regulatory team all strategies, communications, and contents of all meetings, conferences, and discussions with Regulatory Authorities related to each Product, as described in Section 5.2.3 (Meetings with Governmental Authorities); (xviiij) Review coordinate, review, and discuss subcontractors (e.g. contract research organizations, and vendors) and collaboration partners for Joint Development Activities (subject to qualification of such subcontractors in accordance with Laws, GMP and GDP), and report the proposed subcontractors to the JSC for approval; decide on thresholds for seeking the other Party’s approval to engage such subcontractors and partners, and decide which Party (or the Parties) negotiates the respective agreements and signs such agreements with such subcontractor, with the other Party’s prior approval’ Shared Development Costs; (xixk) Review results review, discuss, approve, and coordinate the Apellis Readiness Activities and determine any activities additional to those set out in Schedule 4.3.6 (Apellis Readiness Activities) required to ensure inspection readiness for the PEGASUS and PRINCE Clinical Trials in PNH; (l) review and discuss any material decisions or actions with respect to the EMA PNH Regulatory Approval as described in Section 5.2.5(b) (Regulatory Strategy for EMA PNH Regulatory Approval) and Section 5.2.6(b) (Assignment of subcontracted Joint Development ActivitiesEMA PNH Regulatory Approval); and (m) perform such other non-decision making functions as appropriate to further the purposes of this Agreement, as directed by the JEC, or as specified in this Agreement.

Specific Responsibilities of the JDC. In addition to its general responsibilities, the JDC shall in particular: (i) Manage discuss, prepare and approve for submission to the JSC annual and interim amendments to the Joint Development Plan and Joint Development Budget for each Product; (ii) oversee the conduct of the Development Program; (iii) review and modify the Development FTE Rate used to calculate Joint Development Costs; [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. (iv) review and update monthly financial forecasts to ensure actual and anticipated spend is within the approved Joint Development Budget; (v) create, implement and review the overall strategy for Development and the design and objectives of all Clinical Trials and Non-Clinical Studies conducted under each Joint Development Plan (other than investigator initiated Clinical Trials and Phase 4 Clinical Trials). For the Initial Approval Studies that have not been initiated and Non-Clinical Studies and Clinical Trials that are not included in the Initial Development Plan, the JDC will form a joint development working group for each study with members from each Party (as designated by such Party) that will prepare and make recommendations on study design (including objectives, study endpoints, population, sample size, duration and statistical analysis plan) and the execution of such studies to the JDC and the JDC will review and approve the final study design and protocols for such studies. (vi) decide whether and when to initiate or discontinue, and oversee the preparation conduct of, any Clinical Trial and implementation of the any Non-Clinical Study under each Joint Development Plan; (iivii) Review, discuss and approve non-material amendments allocate budgeted resources (to the Development Plan; (iiiextent applicable) Every [***] months, review, discuss, amend, update and submit to the JSC determine priorities for approval: the Development Plan (subject to Section 3.6), including the each Clinical Trial and Non-Clinical Study under each Joint Development Budget, the TPP, and any material amendments thereto; review and discuss proposals for new Development Activities pursuant to Section 3.5 and seek input from the JCC; (iv) Decide upon which Party will be responsible for the performance of the various activities set forth in the Development Plan on the basis of each Party’s respective experience, capabilities and capacity as set forth in Section 3.11, including which Party will be the Sponsor of a new Global Trial that is a Joint Development Activity; (v) Oversee the conduct and progress of all Trials required as set forth in the Development Plan, including compliance with Laws and applicable GLP, GCP and/or GMP standards, mitigation actions, e.g. clinical Trial liaison activities and medical scientific activities, in order to improve Trial recruitment and Trial site engagement other than Phase 4 Clinical Trials and any Development Activities; (vi) Align with the Medical Affairs function with regards to Early Access Programs and investigator investigator-initiated Clinical Trials; (vii) Review and discuss the progress of any Sole Funded Development Activity; (viii) Coordinate and facilitate the exchange flow of information Information between the Parties under this Agreement regarding the strategy for implementing the Development Activities, including sharing and reviewing of Development Data created pursuant with respect to this Agreement and establishing procedures for the efficient and prompt sharing of information and materials and Know-How reasonably necessary or useful for the Development of the Collaboration Molecules and Product in the Territory; (ix) Coordinate discuss and facilitate exchange by both Parties of Regulatory Data decide whether to Develop (x) Products (other than the Initial Dimebon Product) and Regulatory Materials in support of filings, facility inspections for which indications and (y) the Initial Dimebon Product launch in the Co-Commercialization Territory and the COMPANY Territory; review, discuss and, with respect to Joint Development Activities only, approve the design of the Trial protocols and endpointsfor Other Indications; (x) Discuss allocate primary responsibility as between the Parties for tasks relating to Development of Collaboration Molecules and agree on the regulatory strategy for filing and maintaining Regulatory Approvals Products where not already specified in the Co-Commercialization Territory, in alignment with the JCC;Joint Development Plan; and (xi) Review and discuss perform such other functions as may be appropriate to further the regulatory strategy for filing and maintaining Regulatory Approvals in the COMPANY Territory, in alignment with the JCC; (xii) Review and discuss the contents purposes of all submissions to Regulatory Authorities and Governmental Authorities in the Territory for Regulatory Approvals, Regulatory Materials and all necessary filing and registration activities related thereto; (xiii) Discuss and agree on all matters related to the maintenance of each Party’s safety database and the global safety databasethis Agreement, as applicable; (xiv) Reviewdirected by the JSC or as specified in this Agreement pursuant to Sections 1.139, discuss and oversee issues regarding pharmacovigilance and safety in both the Co-Commercialization Territory and the COMPANY Territory; (xv) Review and provide comments to the JMC regarding Manufacturing Development Activities and discuss progress and issues concerning Manufacturing Development Activities; (xvi) Review and discuss demand forecasts and timelines of Drug Product for supply of the Development Activities under the Supply Agreement and report such demand forecasts and timelines to the JMC; (xvii) Discuss and agree the publication strategy for Development Data; (xviii) Review and discuss subcontractors (e.g. contract research organizations, and vendors3.2(b) and collaboration partners for Joint Development Activities (subject to qualification of such subcontractors in accordance with Laws, GMP and GDP8.2(a)(i), and report the proposed subcontractors to the JSC for approval; decide on thresholds for seeking the other Party’s approval to engage such subcontractors and partners, and decide which Party (or the Parties) negotiates the respective agreements and signs such agreements with such subcontractor, with the other Party’s prior approval; (xix) Review results of subcontracted Joint Development Activities.

Specific Responsibilities of the JDC. In addition The respective applicable JDC will have the following responsibilities: 2.3.2.1 discussing, preparing and determining whether to its general responsibilitiesapprove for submission to the JSC each Joint Development Plan (including the designation of Development Lead Party between the Parties and changes to the Major Development Activities thereunder and the corresponding Joint Development Budget) for the Licensed 217 Products and the Licensed 324 Products, including, in each case, and all annual and interim amendments thereto to add to the applicable Joint Development Plan any Clinical Study or Indications, as described in Section 3.2 (Joint Development Plans) and Section 3.3 (Operational Responsibilities for Development; Additional Development); 2.3.2.2 overseeing, reviewing and discussing the Development of each Licensed Product in the Profit-Share Territory, including (a) overseeing the conduct of all Clinical Studies and Nonclinical Studies, (b) discussing updates from the Parties regarding such Development, and (c) updating the JSC on such Development, in each case, in a manner consistent with Article 3 (Development); 2.3.2.3 (a) determining whether and when to initiate or discontinue any Clinical Studies and any Nonclinical Study that is set forth under each Joint Development Plan, (b) reviewing, discussing and determining whether to approve the final protocols for Clinical Studies and Nonclinical Studies, and (c) reviewing, discussing and determining priorities for each Clinical Study and Nonclinical Study under each Joint Development Plan, provided that the foregoing is not intended to limit a Party’s ability to comply with applicable Law or manage subject safety, in each case, in a manner consistent with Article 3 (Development); 2.3.2.4 determining whether to conduct further Development of the Licensed [**] Products, and, if the JDC shall so determines, then also determining each Party’s responsibilities for the performance of such Development activities and the budget therefor, as described in particular:Section 3.10.1 (Licensed [**] Product Development); (i) Manage and oversee 2.3.2.5 at any time during the preparation and implementation period commencing as of the Effective Date and ending upon the Substitution Termination Date, determining whether to approve the substitution of the Licensed [**] Product for the Licensed 217 Products or the Licensed 324 Products, as described in Section 3.10.1 (Licensed [**] Product Development); 2.3.2.6 determining the feasibility and timing of pursuing, and overseeing collaboration on, new formulations of any Licensed Product for the Profit-Share Territory, in a manner consistent with Article 3 (Development), for inclusion in the applicable Joint Development Plan; 2.3.2.7 serving as a forum for exchange and discussion with respect to Development reports for the Licensed Products for the Profit-Share Territory, as described in Section 3.5 (ii) Review, discuss and approve non-material amendments to the Development PlanReports); (iii) Every 2.3.2.8 [***] months, review, discuss, amend, update and submit to the JSC for approval: the Development Plan (subject to Section 3.6), including the Joint Development Budget, the TPP, and any material amendments thereto; review and discuss proposals for new Development Activities pursuant to Section 3.5 and seek input from the JCC]; (iv) Decide upon which Party will be responsible for the performance of the various activities set forth in the Development Plan on the basis of each Party’s respective experience, capabilities and capacity as set forth in Section 3.11, including which Party will be the Sponsor of a new Global Trial that is a Joint Development Activity; (v) Oversee the conduct and progress of all Trials required as set forth in the Development Plan, including compliance with Laws and applicable GLP, GCP and/or GMP standards, mitigation actions, e.g. clinical Trial liaison activities and medical scientific activities, in order to improve Trial recruitment and Trial site engagement and any Development Activities; (vi) Align with the Medical Affairs function with regards to Early Access Programs and investigator initiated Trials; (vii) Review and discuss the progress of any Sole Funded Development Activity; (viii) Coordinate and facilitate the exchange of information between the Parties under this Agreement regarding the strategy for implementing the Development Activities, including sharing and reviewing of Development Data created pursuant to this Agreement and establishing procedures for the efficient and prompt sharing of information and materials and Know-How reasonably necessary or useful for the Development of the Product in the Territory; (ix) Coordinate and facilitate exchange by both Parties of Regulatory Data and Regulatory Materials in support of filings, facility inspections and Product launch in the Co-Commercialization Territory and the COMPANY Territory; review, discuss and, with respect to Joint Development Activities only, approve the design of the Trial protocols and endpoints; (x) Discuss and agree on the regulatory strategy for filing and maintaining Regulatory Approvals in the Co-Commercialization Territory, in alignment with the JCC; (xi) Review and discuss the regulatory strategy for filing and maintaining Regulatory Approvals in the COMPANY Territory, in alignment with the JCC; (xii) Review and discuss the contents of all submissions to Regulatory Authorities and Governmental Authorities in the Territory for Regulatory Approvals, Regulatory Materials and all necessary filing and registration activities related thereto; (xiii) Discuss and agree on all matters related to the maintenance of each Party’s safety database and the global safety database, as applicable; (xiv) Review, discuss and oversee issues regarding pharmacovigilance and safety in both the Co-Commercialization Territory and the COMPANY Territory; (xv) Review and provide comments to the JMC regarding Manufacturing Development Activities and discuss progress and issues concerning Manufacturing Development Activities; (xvi) Review and discuss demand forecasts and timelines of Drug Product for supply of the Development Activities under the Supply Agreement and report such demand forecasts and timelines to the JMC; (xvii) Discuss and agree the publication strategy for Development Data; (xviii) Review and discuss subcontractors (e.g. contract research organizations, and vendors) and collaboration partners for Joint Development Activities (subject to qualification of such subcontractors in accordance with Laws, GMP and GDP), and report the proposed subcontractors to the JSC for approval; decide on thresholds for seeking the other Party’s approval to engage such subcontractors and partners, and decide which Party (or the Parties) negotiates the respective agreements and signs such agreements with such subcontractor, with the other Party’s prior approval; (xix) Review results of subcontracted Joint Development Activities.

Specific Responsibilities of the JDC. In addition to its general responsibilities, the The JDC shall in particular:, in accordance with the decision-making principles set forth in Section 2.3(c): (i) Manage review Development activities for Licensed Product and oversee Co-Developed Product; (ii) provide a forum for and facilitate communications between the preparation Parties with respect to the Development of Licensed Product and implementation Cancer Product; (iii) facilitate the transfer of Information and materials between the Parties with respect to the Development of Licensed Product and Co-Developed Product (and as needed establish subcommittees to coordinate such transfer); (iv) discuss updates to and progress against the Licensed Field Development Plan; (iiv) Reviewdiscuss updates to the Cancer Development Plan in the case where BMS has not exercised and in the case where BMS does not exercise the Option, in each case to the extent required in Section 3.5; (vi) review proposed Clinical Trials and non-clinical studies in accordance with Section 3.5 and 3.6, and recommend for discussion by the JEC any proposed Clinical Trials and non-clinical studies that may have an Adverse Impact; (vii) review, discuss and approve non-material amendments coordinate the Parties’ scientific presentation and publication plans relating to Licensed Compound and Product, and review any proposed publications pursuant to Section 12.4; [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (viii) in the case where BMS exercises the Option, with respect to the Co-Developed Product: (1) oversee and monitor the Development of Co-Developed Product in accordance with the Joint Cancer Development Plan; (iii2) Every discuss, prepare and recommend for approval by the JEC the annual Joint Cancer Development Plan (and the associated Cancer Development Budget) and any interim amendments thereto; (3) discuss and approve any cost overruns incurred for Clinical Trials in excess of the Cancer Development Budget as described in Section 3.7(f); (4) discuss and recommend for JEC approval decision as to whether and when to initiate or discontinue any Clinical Trial and any nonclinical study under the Joint Cancer Development Plan; (5) discuss the regulatory strategy for Regulatory Approval and oversee regulatory matters in [***] monthsfor the Co-Developed Product; (6) establish a regulatory subcommittee to review all material regulatory aspects of Development of the Co-Developed Product for [***]; (7) review and approve the scientific integrity, review, discuss, amend, update statistical analysis plans and submit to the JSC protocols (and any investigators’ brochure(s) and revisions thereto) for approval: the all Clinical Trials under Joint Cancer Development Plan (subject it being understood that the JDC may delegate to Section 3.6a working group established by the JDC the review of such matters to avoid inappropriate delay), including the Joint Development Budget, the TPP, and any material amendments thereto; review reviewing and discuss proposals for new Development Activities pursuant to Section 3.5 and seek input from the JCCapproving expedited safety reports; (iv) Decide upon which Party will be responsible 8) review the content, strategies for, and other aspects for [***]: product labeling and package insert (including any proposed changes thereto); early access and compassionate use programs; the performance content of, or any change to the then existing content of, any material regulatory filings; the content of the various activities set forth in the Development Plan on the basis of each Party’s respective experience, capabilities any pharmacovigilance reports; any patient risk management and capacity as set forth in Section 3.11, risk minimization strategies and plans; investigator sponsored clinical studies; and significant post–Approval filings and submissions (including which Party will be the Sponsor of a new Global Trial that is a Joint Development Activitysupplements and amendments to Approvals); (v9) Oversee the conduct discuss and progress develop a regulatory strategy plan for obtaining Approvals in [***] and publication strategies for data arising out of all Trials required as set forth in the Development Plan, including compliance with Laws and applicable GLP, GCP and/or GMP standards, mitigation actions, e.g. clinical Trial liaison activities and medical scientific activities, in order to improve Trial recruitment and Trial site engagement and any Development Activities; (vi) Align with the Medical Affairs function with regards to Early Access Programs and investigator initiated co-funded Clinical Trials; (vii10) Review and discuss make recommendations to the progress of any Sole Funded Development ActivityJEC concerning whether to seek new indications for Co-Developed Product; (viii11) Coordinate review, coordinate and align Medical Education Activities for the Co-Developed Product; and (12) review, for JCC approval, packaging designs and trademarks (in accordance with Article 10) for the Co-Developed Product; (ix) facilitate the exchange of information between the Parties under this Agreement regarding the strategy for implementing the Development Activities, including sharing and reviewing of Development Data created pursuant in accordance with Section 4.6 in order to this Agreement and establishing procedures for the efficient and prompt sharing of ensure that significant issues concerning Adverse Event information and materials safety issues are addressed consistently and Know-How reasonably necessary or useful for the Development of the Product in the Territory; (ix) Coordinate and facilitate exchange by both Parties of Regulatory Data and Regulatory Materials in support of filings, facility inspections and Product launch in the Co-Commercialization Territory and the COMPANY Territorya timely manner; review, discuss and, with respect to Joint Development Activities only, approve the design of the Trial protocols and endpoints; (x) Discuss and agree on the regulatory strategy for filing and maintaining Regulatory Approvals in the Co-Commercialization Territory, in alignment with the JCC; (xi) Review and discuss the regulatory strategy for filing and maintaining Regulatory Approvals in the COMPANY Territory, in alignment with the JCC; (xii) Review and discuss the contents of all submissions to Regulatory Authorities and Governmental Authorities in the Territory for Regulatory Approvals, Regulatory Materials and all necessary filing and registration activities related thereto; (xiii) Discuss and agree on all matters related perform such other duties as are expressly assigned to the maintenance of each Party’s safety database and JDC in this Agreement or as may be properly assigned to it by the global safety databaseJEC. [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, as applicable; (xiv) ReviewMARKED BY BRACKETS, discuss and oversee issues regarding pharmacovigilance and safety in both the Co-Commercialization Territory and the COMPANY Territory; (xv) Review and provide comments to the JMC regarding Manufacturing Development Activities and discuss progress and issues concerning Manufacturing Development Activities; (xvi) Review and discuss demand forecasts and timelines of Drug Product for supply of the Development Activities under the Supply Agreement and report such demand forecasts and timelines to the JMC; (xvii) Discuss and agree the publication strategy for Development Data; (xviii) Review and discuss subcontractors (e.g. contract research organizationsIS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, and vendors) and collaboration partners for Joint Development Activities (subject to qualification of such subcontractors in accordance with Laws, GMP and GDP), and report the proposed subcontractors to the JSC for approval; decide on thresholds for seeking the other Party’s approval to engage such subcontractors and partners, and decide which Party (or the Parties) negotiates the respective agreements and signs such agreements with such subcontractor, with the other Party’s prior approval; (xix) Review results of subcontracted Joint Development ActivitiesAS AMENDED.

Specific Responsibilities of the JDC. In addition to support of its general responsibilitiesresponsibility for overseeing, coordinating and expediting the preclinical and clinical development of, and regulatory filings for, Licensed Product, the JDC shall in particular: (i) Manage establish strategy for the preclinical and oversee clinical development and Approval of Licensed Product on a worldwide basis for all indications for which the preparation and implementation of the Development PlanParties have jointly agreed to develop Licensed Products; (ii) Review, discuss propose Development Plans and approve non-material amendments to the Development Planbudgets and Annual Plans and Budgets; (iii) Every [***] monthsdirect the pre-clinical, review, discuss, amend, update clinical and submit to the JSC regulatory program for approval: the Development Plan (subject to Section 3.6)Licensed Product, including the Joint Development Budgetwithout limitation decisions on whether to conduct pre-clinical studies, the TPPPhase I Clinical Trials, and any material amendments thereto; review and discuss proposals for new Development Activities pursuant to Section 3.5 and seek input from the JCCPhase I/II Clinical Trials, Phase II Clinical Trials or Phase III Clinical Trials; (iv) Decide upon which Party will be responsible for monitor the performance progress of the various activities set forth all clinical and pre-clinical studies of Licensed Product in the Development Plan on the basis of each Party’s respective experience, capabilities and capacity as set forth in Section 3.11Territory, including which Party will be reviewing costs and activities against the Sponsor of a new Global Trial that is a Joint Development ActivityPlans and Annual Plans and Budgets; (v) Oversee the conduct and progress of all Trials required as set forth in the Development Plan, including compliance with Laws and applicable GLP, GCP and/or GMP standards, mitigation actions, e.g. clinical Trial liaison activities and medical scientific activities, in order to improve Trial recruitment and Trial site engagement and any Development Activities; (vi) Align with the Medical Affairs function with regards to Early Access Programs and investigator initiated Trials; (vii) Review and discuss the progress of any Sole Funded Development Activity; (viii) Coordinate and facilitate the exchange of information between the Parties under this Agreement regarding the strategy for implementing the Development Activities, including sharing and reviewing of Development Data created pursuant to this Agreement and establishing procedures for the efficient and prompt sharing of all development information and materials and Know-How reasonably necessary or useful data relating to all studies described in subsection (iii) above for the Development of the Licensed Product in the Territory; (vi) review and approve the statistical analysis plans and protocols for all Licensed Product clinical studies conducted in the Territory, and any investigator's brochure(s) and revisions thereto; (vii) work together with the JCC and JMC during the development of Licensed Product to assure a smooth transition from development of such Licensed Product to Commercialization of such Licensed Product; (viii) review and approve any significant agreements (generally an agreement with an expense of more than [*]) with Third Parties to be entered into by either or both Parties that cover the preclinical or clinical development of Licensed Product; (ix) Coordinate discuss and facilitate exchange by both recommend to the Parties whether to initiate research and development of Regulatory Data and Regulatory Materials in support of filings, facility inspections and Product launch (A) Other Licensed Products for use in the Co-Commercialization Territory and Field or (B) additional indications for the COMPANY Territory; review, discuss and, with respect initial Licensed Product to Joint Development Activities only, approve be developed containing the design of the Trial protocols and endpointsE2F Decoy described in Section 1.37(a); (x) Discuss review and agree on approve the regulatory strategy for filing and maintaining Regulatory Approvals in the Co-Commercialization Territory, in alignment with the JCCscientific integrity of Phase IV Clinical Trials; (xi) Review provide updates on its activities and discuss achievements to the regulatory strategy for filing and maintaining Regulatory Approvals in the COMPANY Territory, in alignment with the JCCJSC; (xii) Review review and discuss approve activities of the contents of all submissions to Regulatory Authorities and Governmental Authorities in the Territory for Regulatory Approvals, Regulatory Materials and all necessary filing and registration activities related theretoRWG; (xiii) Discuss work with the JCC to make recommendations for approval by the JSC for early access and agree on all matters related to the maintenance of each Party’s safety database and the global safety database, as applicable;compassionate use programs; and (xiv) Review, discuss and oversee issues regarding pharmacovigilance and safety in both the Co-Commercialization Territory and the COMPANY Territory; (xv) Review and provide comments to the JMC regarding Manufacturing Development Activities and discuss progress and issues concerning Manufacturing Development Activities; (xvi) Review and discuss demand forecasts and timelines of Drug Product for supply of the Development Activities under the Supply Agreement and report such demand forecasts and timelines to the JMC; (xvii) Discuss and agree the publication strategy for Development Data; (xviii) Review and discuss subcontractors (e.g. contract research organizations, and vendors) and collaboration partners for Joint Development Activities (subject to qualification of such subcontractors in accordance with Laws, GMP and GDP), and report the proposed subcontractors to the JSC for approval; decide on thresholds for seeking the other Party’s approval to engage such subcontractors and partners, and decide which Party (or the Parties) negotiates the respective agreements and signs such agreements with such subcontractor, coordinate with the other Party’s prior approval; (xix) Review results of subcontracted Joint Development ActivitiesJCC, JMC and JFC as appropriate.

Specific Responsibilities of the JDC. In addition to its general responsibilities, the The JDC shall in particularshall: (i) Manage discuss, prepare and oversee approve for submission to the preparation and implementation of JSC all Joint Development Plans (including Joint Development Budgets) for Products in the Territory (except for the Initial Joint Development Plan), and all annual and interim amendments to Joint Development Plans (including Joint Development Budgets) for each Product; (ii) Review, discuss and approve non-material amendments to oversee the conduct of the Development PlanProgram; (iii) Every [***] months, review, discuss, amend, update review and submit recommend for the Parties’ consideration modifications to the JSC for approval: the Development Plan (subject FTE Rates used to Section 3.6), including the calculate Joint Development Budget, the TPP, and any material amendments thereto; review and discuss proposals for new Development Activities pursuant to Section 3.5 and seek input from the JCCCosts; (iv) Decide upon which Party will be responsible create, implement and review the overall strategy for global Development and the performance design of the various activities set forth in the all Clinical Trials and Nonclinical Studies conducted under each Joint Development Plan on the basis of each Party’s respective experience, capabilities and capacity as set forth in Section 3.11Plan, including which Party will be the Sponsor of a new Global Trial that is a Joint Development ActivityRequired Phase 4 Clinical Trials; (v) Oversee the conduct decide whether and progress of all Trials required as set forth in the when to initiate or discontinue any Clinical Trial and any Nonclinical Study under each Joint Development Plan, including compliance Required Phase 4 [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with Laws the Securities and applicable GLPExchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, GCP and/or GMP standardsas amended. Clinical Trials, mitigation actions, e.g. clinical Trial liaison activities and medical scientific activities, in order provided that nothing is intended to improve Trial recruitment and Trial site engagement and any Development Activitieslimit a Party’s ability to comply with Applicable Law or manage subject safety; (vi) Align with the Medical Affairs function with regards to Early Access Programs allocate budgeted resources and investigator initiated determine priorities for each Clinical Trial and Nonclinical Study under each Joint Development Plan, including Required Phase 4 Clinical Trials; (vii) Review oversee the conduct of all Clinical Trials and discuss the progress of any Sole Funded Nonclinical Studies under each Joint Development ActivityPlan, including Required Phase 4 Clinical Trials; (viii) Coordinate and facilitate the exchange flow of information between the Parties under this Agreement regarding the strategy for implementing the Development Activities, including sharing and reviewing of Development Data created pursuant with respect to this Agreement and establishing procedures for the efficient and prompt sharing of information and materials and Know-How reasonably necessary or useful for the Development of the Product in the TerritoryProducts; (ix) Coordinate discuss and facilitate exchange by both Parties of Regulatory Data and Regulatory Materials in support of filingsdecide whether to Develop (x) any Product other than an MDV3100 Product (including any Backup Product), facility inspections and (y) any Combination Product launch in the Co-Commercialization Territory and the COMPANY Territory; review, discuss and, with respect to Joint Development Activities only, approve the design of the Trial protocols and endpoints(including any Combination Product including MDV3100) or (z) any Product for any Other Indication; (x) Discuss and agree on allocate primary responsibility as between the regulatory strategy Parties for filing and maintaining Regulatory Approvals tasks relating to Development of Products where not already specified in the Co-Commercialization Territory, in alignment with the JCCJoint Development Plan; (xi) Review discuss the requirements for Regulatory Approval in the Territory and discuss (x) with respect to the Shared Territory, approve the regulatory strategy for filing and maintaining Regulatory Approvals coordinate regulatory matters with respect to Products in accordance with Section 4.1, and (y) with respect to the COMPANY Licensed Territory, in alignment review the regulatory strategy with the JCCrespect to Products; (xii) Review and discuss without limitation to clause (xi), (A) determine the contents of all submissions to Regulatory Authorities and Governmental Authorities regulatory strategy regarding the special protocol assessments contemplated in the Territory for Regulatory ApprovalsInitial Joint Development Plan, Regulatory Materials (B) approve the content of the protocol(s) to be submitted to the FDA in connection with such special protocol assessments and all necessary filing and registration activities related thereto(C) determine whether to recommend to the JSC whether to initiate a pivotal Clinical Trial with respect to either the [*] Indication or the [*] Indication (but not both, unless otherwise determined by the JDC); (xiii) Discuss without limitation to clause (xi), determine the regulatory strategy with respect to discussions with and agree on all matters related commitments to the maintenance of each Party’s safety database and the global safety databaseor agreements with Regulatory Authorities (including post-approval commitments) with respect to Product labeling, as applicablerisk management or Required Phase 4 Clinical Trials; (xiv) Reviewwithout limitation to clause (xi), discuss review and oversee issues regarding pharmacovigilance approve any material submission to, or any material agreement with or material commitment made to, a Regulatory Authority with respect to a Product, such as any NDA or MAA, or any submission, agreement or commitment with respect to Product labeling, any risk management plans, any Required Phase 4 Clinical Trial or other post-approval commitment for such Product, in each case with respect to the Shared Territory, the EU and safety in both the Co-Commercialization Territory and the COMPANY TerritoryJapan; (xv) Review facilitate the flow of information between the Parties with respect obtaining Regulatory Approval for Products; and provide comments [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the JMC regarding Manufacturing Development Activities and discuss progress and issues concerning Manufacturing Development Activities;Securities Exchange Act of 1934, as amended. (xvi) Review and discuss demand forecasts and timelines perform such other functions as may be appropriate to further the purposes of Drug Product for supply of this Agreement, as directed by the Development Activities under the Supply Agreement and report such demand forecasts and timelines to the JMC; (xvii) Discuss and agree the publication strategy for Development Data; (xviii) Review and discuss subcontractors (e.g. contract research organizations, and vendors) and collaboration partners for Joint Development Activities (subject to qualification of such subcontractors JSC in accordance with Laws, GMP and GDPSection 2.2(c)(x), and report the proposed subcontractors . References to Clinical Trials in clauses (iv) through (vii) shall be deemed to include only those Voluntary Phase 4 Clinical Trials that the JSC for approval; decide on thresholds for seeking has directed be undertaken by the other Party’s approval to engage such subcontractors and partners, and decide which Party (or JDC instead of the Parties) negotiates the respective agreements and signs such agreements with such subcontractor, with the other Party’s prior approval; (xix) Review results of subcontracted Joint Development ActivitiesJMAC.

Specific Responsibilities of the JDC. In addition to its general responsibilities, the JDC (or the JSC until the JDC is formed, with certain delegations as set forth in this Section 2.3 and Schedule G(a)) shall in particular: (i) Manage and oversee provide regular reports to the preparation and implementation JSC regarding the development of the Product, and discuss, prepare and submit to the JSC for approval annual and interim amendments to the Development PlanPlan (and the Development Budget) for each Product; (ii) Review, discuss and approve non-material amendments to manage the implementation of the Initial Development Plan; (iii) Every [***] months, review, discuss, amend, update and submit to oversee the JSC for approval: the Development Plan (subject to Section 3.6), including the Joint Development Budget, the TPP, and any material amendments thereto; review and discuss proposals for new Development Activities pursuant to Section 3.5 and seek input from the JCCconduct of Development; (iv) Decide upon which Party will be responsible for discuss the performance of audited final report from the various activities set forth in the Development Plan on the basis of each Party’s respective experience, capabilities and capacity as set forth in Section 3.11Carcinogenicity Studies, including which Party will be whether or not a Technical Product Failure has occurred, and provide input thereon to the Sponsor of a new Global Trial that is a Joint Development ActivityJSC; (v) Oversee propose to the conduct and progress of all Trials required as set forth in the Development Plan, including compliance with Laws and applicable GLP, GCP and/or GMP standards, mitigation actions, e.g. clinical Trial liaison activities and medical scientific activities, in order JSC particular studies to improve Trial recruitment and Trial site engagement and any Development Activitiesbe conducted; (vi) Align with create, implement and review the Medical Affairs function with regards to Early Access Programs Development Strategy for Development in the Territory and investigator initiated the design of all Clinical Trials and Nonclinical Studies conducted under each Development Plan, including Phase 4 Clinical Trials; (vii) Review oversee any CMC related development activities, e.g. stability studies or packaging development, as well as other activities to prepare for supply of drug substance and discuss finished Product for Commercialization, including to oversee the progress of any Sole Funded Development Activityselection process for, and select (pursuant to Section 6.4), a contract manufacturer to be used by FibroGen for commercial supplies; (viii) Coordinate decide whether and facilitate the exchange of information between the Parties when to initiate or discontinue any Clinical Trial and any Nonclinical Study under this Agreement regarding the strategy for implementing the each Development ActivitiesPlan, including sharing and reviewing of Development Data created pursuant to this Agreement and establishing procedures for the efficient and prompt sharing of information and materials and Know-How reasonably necessary or useful for the Development of the Product in the TerritoryPhase 4 Clinical Trials; (ix) Coordinate allocate budgeted resources and facilitate exchange by both Parties of Regulatory Data determine priorities for each Clinical Trial and Regulatory Materials in support of filingsNonclinical Study under each Development Plan, facility inspections and Product launch in the Co-Commercialization Territory and the COMPANY Territory; review, discuss and, with respect to Joint Development Activities only, approve the design of the Trial protocols and endpointsincluding Phase 4 Clinical Trials; (x) Discuss oversee the conduct of all Clinical Trials and agree on the regulatory strategy for filing and maintaining Regulatory Approvals in the Co-Commercialization TerritoryNonclinical Studies under each Development Plan, in alignment with the JCCincluding Phase 4 Clinical Trials; (xi) Review and discuss the regulatory strategy for filing and maintaining Regulatory Approvals in the COMPANY Territory, in alignment with the JCCselect Third Party contractors to conduct Clinical Trials of Products; (xii) Review and discuss facilitate the contents flow of all submissions Information between the Parties with respect to Regulatory Authorities and Governmental Authorities in the Territory for Regulatory ApprovalsDevelopment of Products, Regulatory Materials and all necessary filing and registration activities related theretoincluding Development Data [ * ] under this Agreement; (xiii) Discuss discuss whether to Develop Products for other indications and agree on all matters related propose any such indications to the maintenance of each Party’s safety database and the global safety database, as applicableJSC; (xiv) Review, discuss and oversee issues regarding pharmacovigilance and safety allocate primary responsibility as between the Parties for tasks relating to Development of Products where not already specified in both the Co-Commercialization Territory and the COMPANY TerritoryDevelopment Plan; (xv) Review discuss the requirements for Regulatory Approval in the Territory and provide comments oversee and coordinate regulatory matters with respect to Products in the JMC regarding Manufacturing Development Activities Territory, including to review and discuss progress and issues concerning Manufacturing Development Activitiesapprove material regulatory filings (other than the filing of an NDA in the U.S., which shall be approved by the JSC) prior to submission thereof; (xvi) Review establish a publication strategy for publications and discuss demand forecasts presentations related to Products in the Territory and timelines of Drug Product for supply of the Development Activities under the Supply Agreement review and report approve all such demand forecasts and timelines to the JMCpublications in accordance with Section 12.5; (xvii) Discuss and agree facilitate the publication strategy flow of Information between the Parties with respect to obtaining Regulatory Approval for Development Data;Products; and (xviii) Review and discuss subcontractors (e.g. contract research organizationsperform such other functions as may be appropriate to further the purposes of this Agreement, and vendors) and collaboration partners for Joint Development Activities (subject to qualification of such subcontractors in accordance with Laws, GMP and GDP), and report as directed by the proposed subcontractors to the JSC for approval; decide on thresholds for seeking the other Party’s approval to engage such subcontractors and partners, and decide which Party (or the Parties) negotiates the respective agreements and signs such agreements with such subcontractor, with the other Party’s prior approval; (xix) Review results of subcontracted Joint Development ActivitiesJSC.

Specific Responsibilities of the JDC. In addition to its general responsibilities, The JDC will have the JDC shall following responsibilities in particularconnection with the Collaboration: (i) Manage 2.3.2.1. overseeing and oversee the preparation and implementation of reviewing the Development Planof each Licensed Product in the Licensee Territory, including the conduct of any Post-Marketing Study; (ii) Review, discuss 2.3.2.2. reviewing and approve non-material providing input on any amendments to the Development Plan; (iii) Every [***] months, review, discuss, amend, update and submit to the JSC for approval: the Development Plan (subject to Section 3.6), including the Joint Development Budget, the TPP, and any material amendments thereto; review and discuss proposals for new Development Activities pursuant to Section 3.5 and seek input from the JCC; (iv) Decide upon which Party will be responsible for the performance of the various activities set forth in the Development Plan on the basis of each Party’s respective experience, capabilities and capacity as set forth in Section 3.11, including which Party will be the Sponsor of a new Global Trial that is a Joint Development Activity; (v) Oversee the conduct and progress of all Trials required as set forth in the Initial Indications Development Plan, including compliance with Laws and applicable GLPthe proposed addition of any PMDA-Required Supplemental Study or Licensee Additional Development Activities thereto, GCP and/or GMP standards, mitigation actions, e.g. clinical Trial liaison activities and medical scientific activities, in order to improve Trial recruitment and Trial site engagement and for approval by the JSC of any Development Activitiessuch amendments; (vi) Align with 2.3.2.3. reviewing and providing input on any Licensee Additional Development Proposals and corresponding Licensee Additional Development Activities proposed to be conducted, for approval thereof by the Medical Affairs function with regards to Early Access Programs and investigator initiated TrialsJSC; (vii) Review 2.3.2.4. reviewing and discuss providing input on any proposed Post-Marketing Studies for any Licensed Product in the progress of any Sole Funded Development ActivityLicensee Territory, for approval thereof by the JSC; (viii) Coordinate 2.3.2.5. creating and implementing the overall strategy regarding Regulatory Approval of Licensed Products in the Licensee Territory, including content of label or other prescribing information; 2.3.2.6. reporting on subcontracting services pursuant to Section 3.6; 2.3.2.7. without limiting Section 2.3.2.5, reviewing and providing input on any material Regulatory Filings to Regulatory Authorities for Regulatory Approval of Licensed Products in the Licensee Territory; 2.3.2.8. determining and overseeing a reasonable and expeditious process to identify, and under which C▇▇▇▇▇ will provide to Licensee, any submissions, filings or other material communications with a Regulatory Authority with respect to a Licensed Product in the C▇▇▇▇▇ Territory to which Licensee needs access to support obtaining or maintaining a Regulatory Approval for a Licensed Product in the Licensee Territory; 2.3.2.9. without limiting Sections 2.3.2.5 and 2.3.2.7, providing a forum to facilitate the exchange flow of information between the Parties under this Agreement regarding the strategy for implementing the Development Activities, including sharing and reviewing of Development Data created pursuant to this Agreement and establishing procedures for the efficient and prompt sharing of information and materials and Know-How reasonably necessary or useful for the Development of the Product in the Territory; (ix) Coordinate and facilitate exchange by both Parties of Regulatory Data and Regulatory Materials in support of filings, facility inspections and Product launch in the Co-Commercialization Territory and the COMPANY Territory; review, discuss and, with respect to Joint the Development Activities only, approve the design and Regulatory Approval of the Trial protocols and endpoints; (x) Discuss and agree on the regulatory strategy for filing and maintaining Regulatory Approvals Licensed Products in the Co-Commercialization Licensee Territory, in alignment including the reporting of and discussion of communications with the JCC;Regulatory Authorities; and (xi) Review 2.3.2.10. reviewing and discuss the regulatory strategy for filing and maintaining Regulatory Approvals in the COMPANY Territory, in alignment with the JCC; (xii) Review and discuss the contents of all submissions to Regulatory Authorities and Governmental Authorities in the Territory for Regulatory Approvals, Regulatory Materials and all necessary filing and registration activities related thereto; (xiii) Discuss and agree providing input on all matters related any proposed amendments to the maintenance of each Party’s safety database and the global safety database, as applicable; (xiv) Review, discuss and oversee issues regarding pharmacovigilance and safety in both the Co-Commercialization Territory and the COMPANY Territory; (xv) Review and provide comments to the JMC regarding Manufacturing Development Activities and discuss progress and issues concerning Manufacturing Development Activities; (xvi) Review and discuss demand forecasts and timelines of Drug Product CMC Work Plan for supply of the Development Activities under the Supply Agreement and report such demand forecasts and timelines to the JMC; (xvii) Discuss and agree the publication strategy for Development Data; (xviii) Review and discuss subcontractors (e.g. contract research organizations, and vendors) and collaboration partners for Joint Development Activities (subject to qualification of such subcontractors in accordance with Laws, GMP and GDP), and report the proposed subcontractors to approval by the JSC for approval; decide on thresholds for seeking the other Party’s approval to engage of any material such subcontractors and partners, and decide which Party (or the Parties) negotiates the respective agreements and signs such agreements with such subcontractor, with the other Party’s prior approval; (xix) Review results of subcontracted Joint Development Activitiesamendments.

Specific Responsibilities of the JDC. In addition to its general responsibilities, the The JDC shall in particularshall: (i) Manage discuss, prepare and oversee approve for submission to the preparation and implementation of JSC all Joint Development Plans (including Joint Development Budgets) for Products in the Territory (except for the Initial Joint Development Plan), and all annual and interim amendments to Joint Development Plans (including Joint Development Budgets) for each Product; (ii) Review, discuss and approve non-material amendments to oversee the conduct of the Development PlanProgram; (iii) Every [***] months, review, discuss, amend, update review and submit recommend for the Parties’ consideration modifications to the JSC for approval: the Development Plan (subject FTE Rates used to Section 3.6), including the calculate Joint Development Budget, the TPP, and any material amendments thereto; review and discuss proposals for new Development Activities pursuant to Section 3.5 and seek input from the JCCCosts; (iv) Decide upon which Party will be responsible create, implement and review the overall strategy for global Development and the performance design of the various activities set forth in the all Clinical Trials and Nonclinical Studies conducted under each Joint Development Plan on the basis of each Party’s respective experience, capabilities and capacity as set forth in Section 3.11Plan, including which Party will be the Sponsor of a new Global Trial that is a Joint Development ActivityRequired Phase 4 Clinical Trials; (v) Oversee the conduct decide whether and progress of all Trials required as set forth in the when to initiate or discontinue any Clinical Trial and any Nonclinical Study under each Joint Development Plan, including compliance Required Phase 4 Clinical Trials, provided that nothing is intended to limit a Party’s ability to comply with Laws and applicable GLP, GCP and/or GMP standards, mitigation actions, e.g. clinical Trial liaison activities and medical scientific activities, in order to improve Trial recruitment and Trial site engagement and any Development ActivitiesApplicable Law or manage subject safety; (vi) Align with the Medical Affairs function with regards to Early Access Programs allocate budgeted resources and investigator initiated determine priorities for each Clinical Trial and Nonclinical Study under each Joint Development Plan, including Required Phase 4 Clinical Trials; (vii) Review oversee the conduct of all Clinical Trials and discuss the progress of any Sole Funded Nonclinical Studies under each Joint Development ActivityPlan, including Required Phase 4 Clinical Trials; (viii) Coordinate and facilitate the exchange flow of information between the Parties under this Agreement regarding the strategy for implementing the Development Activities, including sharing and reviewing of Development Data created pursuant with respect to this Agreement and establishing procedures for the efficient and prompt sharing of information and materials and Know-How reasonably necessary or useful for the Development of the Product in the TerritoryProducts; (ix) Coordinate discuss and facilitate exchange by both Parties of Regulatory Data and Regulatory Materials in support of filingsdecide whether to Develop (x) any Product other than an MDV3100 Product (including any Backup Product), facility inspections and (y) any Combination Product launch in the Co-Commercialization Territory and the COMPANY Territory; review, discuss and, with respect to Joint Development Activities only, approve the design of the Trial protocols and endpoints(including any Combination Product including MDV3100) or (z) any Product for any Other Indication; (x) Discuss and agree on allocate primary responsibility as between the regulatory strategy Parties for filing and maintaining Regulatory Approvals tasks relating to Development of Products where not already specified in the Co-Commercialization Territory, in alignment with the JCCJoint Development Plan; (xi) Review discuss the requirements for Regulatory Approval in the Territory and discuss (x) with respect to the Shared Territory, approve the regulatory strategy for filing and maintaining Regulatory Approvals coordinate regulatory matters with respect to Products in accordance with Section 4.1, and (y) with respect to the COMPANY Licensed Territory, in alignment review the regulatory strategy with the JCCrespect to Products; (xii) Review and discuss without limitation to clause (xi), (A) determine the contents of all submissions to Regulatory Authorities and Governmental Authorities regulatory strategy regarding the special protocol assessments contemplated in the Territory for Regulatory ApprovalsInitial Joint Development Plan, Regulatory Materials (B) approve the content of the protocol(s) to be submitted to the FDA in connection with such special protocol assessments and all necessary filing and registration activities related thereto(C) determine whether to recommend to the JSC whether to initiate a pivotal Clinical Trial with respect to either the [*] Indication or the [*] Indication (but not both, unless otherwise determined by the JDC); (xiii) Discuss without limitation to clause (xi), determine the regulatory strategy with respect to discussions with and agree on all matters related commitments to the maintenance of each Party’s safety database and the global safety databaseor agreements with Regulatory Authorities (including post-approval commitments) with respect to Product labeling, as applicablerisk management or Required Phase 4 Clinical Trials; (xiv) Reviewwithout limitation to clause (xi), discuss review and oversee issues regarding pharmacovigilance approve any material submission to, or any material agreement with or material commitment made to, a Regulatory Authority with respect to a Product, such as any NDA or MAA, or any submission, agreement or commitment with respect to Product labeling, any risk management plans, any Required Phase 4 Clinical Trial or other post-approval commitment for such Product, in each case with respect to the Shared Territory, the EU and safety Japan; [*] = Certain confidential information contained in both this document, marked by brackets, has been omitted and filed separately with the Co-Commercialization Territory securities and exchange commission pursuant to rule 24b-2 of the COMPANY Territory;securities exchange act of 1934, as amended. (xv) Review and provide comments to facilitate the JMC regarding Manufacturing Development Activities and discuss progress and issues concerning Manufacturing Development Activities;flow of information between the Parties with respect obtaining Regulatory Approval for Products; and (xvi) Review and discuss demand forecasts and timelines perform such other functions as may be appropriate to further the purposes of Drug Product for supply of this Agreement, as directed by the Development Activities under the Supply Agreement and report such demand forecasts and timelines to the JMC; (xvii) Discuss and agree the publication strategy for Development Data; (xviii) Review and discuss subcontractors (e.g. contract research organizations, and vendors) and collaboration partners for Joint Development Activities (subject to qualification of such subcontractors JSC in accordance with Laws, GMP and GDPSection 2.2(c)(x), and report the proposed subcontractors . References to Clinical Trials in clauses (iv) through (vii) shall be deemed to include only those Voluntary Phase 4 Clinical Trials that the JSC for approval; decide on thresholds for seeking has directed be undertaken by the other Party’s approval to engage such subcontractors and partners, and decide which Party (or JDC instead of the Parties) negotiates the respective agreements and signs such agreements with such subcontractor, with the other Party’s prior approval; (xix) Review results of subcontracted Joint Development ActivitiesJMAC.

Specific Responsibilities of the JDC. In addition to its general responsibilities, the The JDC shall in particularhave the following responsibilities: (i) Manage Discuss all Development Plans prepared by Gilead (including Development Budgets), and oversee the preparation all annual and implementation of the Development Plan; (ii) Review, discuss and approve non-material interim amendments to the Development Plan; Plans (iiiincluding Development Budgets) Every [***] monthsfor, review, discuss, amend, update and submit to the JSC for approval: the Development Plan (subject to Section 3.6), including the Joint Development Budget, the TPP, and any material amendments thereto; review and discuss proposals for new Development Activities pursuant to Section 3.5 and seek input from the JCC; (iv) Decide upon which Party will be responsible for the performance of the various activities set forth in the Development Plan on the basis of each Party’s respective experience, capabilities and capacity as set forth in Section 3.11, including which Party will be the Sponsor of a new Global Trial that is a Joint Development Activity; (v) Oversee the conduct and progress of all Trials required as set forth in the Development Plan, including compliance with Laws and applicable GLP, GCP and/or GMP standards, mitigation actions, e.g. clinical Trial liaison activities and medical scientific activities, in order to improve Trial recruitment and Trial site engagement and any Development Activities; (vi) Align with the Medical Affairs function with regards to Early Access Programs and investigator initiated Trials; (vii) Review and discuss the progress of any Sole Funded Development Activity; (viii) Coordinate and facilitate the exchange of information between the Parties under this Agreement regarding the strategy for implementing the Development Activities, including sharing and reviewing of Development Data created pursuant to this Agreement and establishing procedures for the efficient and prompt sharing of information and materials and Know-How reasonably necessary or useful for the Development of the Product Licensed Compound in the Territory; (ixii) Coordinate and facilitate exchange by both Parties review the conduct of Regulatory Data and Regulatory Materials in support the Development Plans; (iii) discuss Development of filings, facility inspections and Product launch new indications for Licensed Products in the Co-Commercialization Territory Territory: (iv) implement and review the overall strategy created for global Development and the COMPANY Territory; reviewdesign of all Clinical Trials and Nonclinical Studies conducted under each Development Plan; (v) discuss whether and when to initiate or discontinue any Clinical Trial and any Nonclinical Study under each Development Plan, discuss andprovided that nothing is intended to limit a Party’s ability to comply with Applicable Law or manage subject safety; (vi) review the conduct of all Clinical Trials and Nonclinical Studies under each Development Plan, including Required Phase 4 Clinical Trials or any other Phase 4 Clinical Trial included in Development; (vii) facilitate the flow of information between the Parties with respect to Joint the Development Activities onlyof Licensed Compound; (viii) implement and review the overall strategy regarding Regulatory Approval of Licensed Products in the Territory created by Gilead; (ix) discuss Manufacturing, approve the design of the Trial protocols including progress with formulation, validation scaleup, and endpointsother activities to maintain supply; (x) Discuss and agree on review the regulatory strategy for filing with respect to discussions with and maintaining commitments to or agreements with Regulatory Approvals Authorities (including post-approval commitments) with respect to risk management or Required Phase 4 Clinical Trials or any other Phase 4 Clinical Trial included in the Co-Commercialization Territory, in alignment with the JCCDevelopment; (xi) Review and discuss the regulatory strategy review any material submission to, or any material agreement with or material commitment made to, a Regulatory Authority by Gilead with respect to a Licensed Product, such as any NDA or MAA, or any submission, agreement or commitment with respect to Licensed Product labeling, any risk management plans, any Required Phase 4 Clinical Trial or any other Phase 4 Clinical Trial included in Development or other post-approval commitment for filing and maintaining Regulatory Approvals in the COMPANY Territorysuch Licensed Product, in alignment each case with respect to the JCCMajor Markets; (xii) Review and discuss facilitate the contents flow of all submissions to information between the Parties with respect obtaining Regulatory Authorities and Governmental Authorities in the Territory Approval for Regulatory Approvals, Regulatory Materials and all necessary filing and registration activities related thereto;Licensed Products; and (xiii) Discuss and agree on all matters related to the maintenance of each Party’s safety database and the global safety database, as applicable; (xiv) Reviewreview, discuss and oversee issues regarding pharmacovigilance coordinate the Parties’ scientific presentation and safety in both the Co-Commercialization Territory and the COMPANY Territory; (xv) Review and provide comments publication strategy relating to the JMC regarding Manufacturing Development Activities and discuss progress and issues concerning Manufacturing Development Activities; (xvi) Review and discuss demand forecasts and timelines of Drug Product for supply of Licensed Products in the Development Activities under the Supply Agreement and report such demand forecasts and timelines to the JMC; (xvii) Discuss and agree the publication strategy for Development Data; (xviii) Review and discuss subcontractors (e.g. contract research organizations, and vendors) and collaboration partners for Joint Development Activities (subject to qualification of such subcontractors in accordance with Laws, GMP and GDP), and report the proposed subcontractors to the JSC for approval; decide on thresholds for seeking the other Party’s approval to engage such subcontractors and partners, and decide which Party (or the Parties) negotiates the respective agreements and signs such agreements with such subcontractor, with the other Party’s prior approval; (xix) Review results of subcontracted Joint Development ActivitiesTerritory.

Specific Responsibilities of the JDC. In addition The respective applicable JDC will have the following responsibilities: 2.3.2.1 discussing, preparing and determining whether to its general responsibilitiesapprove for submission to the JSC each Joint Development Plan (including the designation of Development Lead Party between the Parties and changes to the Major Development Activities thereunder and the corresponding Joint Development Budget) for the Licensed 217 Products and the Licensed 324 Products, including, in each case, and all annual and interim amendments thereto to add to the applicable Joint Development Plan any Clinical Study or Indications, as described in Section 3.2 (Joint Development Plans) and Section 3.3 (Operational Responsibilities for Development; Additional Development); 2.3.2.2 overseeing, reviewing and discussing the Development of each Licensed Product in the Profit-Share Territory, including (a) overseeing the conduct of all Clinical Studies and Nonclinical Studies, (b) discussing updates from the Parties regarding such Development, and (c) updating the JSC on such Development, in each case, in a manner consistent with Article 3 (Development); (a) determining whether and when to initiate or discontinue any Clinical Studies and any Nonclinical Study that is set forth under each Joint Development Plan, (b) reviewing, discussing and determining whether to approve the final protocols for Clinical Studies and Nonclinical Studies, and (c) reviewing, discussing and determining priorities for each Clinical Study and Nonclinical Study under each Joint Development Plan, provided that the foregoing is not intended to limit a Party’s ability to comply with applicable Law or manage subject safety, in each case, in a manner consistent with Article 3 (Development); 2.3.2.4 determining whether to conduct further Development of the Licensed [**] Products, and, if the JDC shall so determines, then also determining each Party’s responsibilities for the performance of such Development activities and the budget therefor, as described in particular:Section 3.10.1 (Licensed [**] Product Development); (i) Manage and oversee 2.3.2.5 at any time during the preparation and implementation period commencing as of the Effective Date and ending upon the Substitution Termination Date, determining whether to approve the substitution of the Licensed [**] Product for the Licensed 217 Products or the Licensed 324 Products, as described in Section 3.10.1 (Licensed [**] Product Development); 2.3.2.6 determining the feasibility and timing of pursuing, and overseeing collaboration on, new formulations of any Licensed Product for the Profit-Share Territory, in a manner consistent with Article 3 (Development), for inclusion in the applicable Joint Development Plan; 2.3.2.7 serving as a forum for exchange and discussion with respect to Development reports for the Licensed Products for the Profit-Share Territory, as described in Section 3.5 (ii) Review, discuss and approve non-material amendments to the Development PlanReports); (iii) Every 2.3.2.8 [***] months, review, discuss, amend, update and submit to the JSC for approval: the Development Plan (subject to Section 3.6), including the Joint Development Budget, the TPP, and any material amendments thereto; review and discuss proposals for new Development Activities pursuant to Section 3.5 and seek input from the JCC]; (iv) Decide upon which Party will be responsible for the performance of the various activities set forth in the Development Plan on the basis of each Party’s respective experience, capabilities and capacity as set forth in Section 3.11, including which Party will be the Sponsor of a new Global Trial that is a Joint Development Activity; (v) Oversee the conduct and progress of all Trials required as set forth in the Development Plan, including compliance with Laws and applicable GLP, GCP and/or GMP standards, mitigation actions, e.g. clinical Trial liaison activities and medical scientific activities, in order to improve Trial recruitment and Trial site engagement and any Development Activities; (vi) Align with the Medical Affairs function with regards to Early Access Programs and investigator initiated Trials; (vii) Review and discuss the progress of any Sole Funded Development Activity; (viii) Coordinate and facilitate the exchange of information between the Parties under this Agreement regarding the strategy for implementing the Development Activities, including sharing and reviewing of Development Data created pursuant to this Agreement and establishing procedures for the efficient and prompt sharing of information and materials and Know-How reasonably necessary or useful for the Development of the Product in the Territory; (ix) Coordinate and facilitate exchange by both Parties of Regulatory Data and Regulatory Materials in support of filings, facility inspections and Product launch in the Co-Commercialization Territory and the COMPANY Territory; review, discuss and, with respect to Joint Development Activities only, approve the design of the Trial protocols and endpoints; (x) Discuss and agree on the regulatory strategy for filing and maintaining Regulatory Approvals in the Co-Commercialization Territory, in alignment with the JCC; (xi) Review and discuss the regulatory strategy for filing and maintaining Regulatory Approvals in the COMPANY Territory, in alignment with the JCC; (xii) Review and discuss the contents of all submissions to Regulatory Authorities and Governmental Authorities in the Territory for Regulatory Approvals, Regulatory Materials and all necessary filing and registration activities related thereto; (xiii) Discuss and agree on all matters related to the maintenance of each Party’s safety database and the global safety database, as applicable; (xiv) Review, discuss and oversee issues regarding pharmacovigilance and safety in both the Co-Commercialization Territory and the COMPANY Territory; (xv) Review and provide comments to the JMC regarding Manufacturing Development Activities and discuss progress and issues concerning Manufacturing Development Activities; (xvi) Review and discuss demand forecasts and timelines of Drug Product for supply of the Development Activities under the Supply Agreement and report such demand forecasts and timelines to the JMC; (xvii) Discuss and agree the publication strategy for Development Data; (xviii) Review and discuss subcontractors (e.g. contract research organizations, and vendors) and collaboration partners for Joint Development Activities (subject to qualification of such subcontractors in accordance with Laws, GMP and GDP), and report the proposed subcontractors to the JSC for approval; decide on thresholds for seeking the other Party’s approval to engage such subcontractors and partners, and decide which Party (or the Parties) negotiates the respective agreements and signs such agreements with such subcontractor, with the other Party’s prior approval; (xix) Review results of subcontracted Joint Development Activities.

Specific Responsibilities of the JDC. In addition to its general responsibilities, the The JDC shall in particularhave the following responsibilities: (i) Manage Discuss all Development Plans prepared by Gilead (including Development Budgets), and oversee all annual and interim amendments to Development Plans (including Development Budgets) for, Licensed Compound in the preparation and implementation Territory; (ii) review the conduct of the Development Plans; (iii) discuss Development of new indications for Licensed Products in the Territory: (iv) implement and review the overall strategy created by Gilead for global Development and the design of all Clinical Trials and Nonclinical Studies conducted under each Development Plan; (iiv) Review, discuss whether and approve non-material amendments when to the Development Plan; (iii) Every [***] months, review, discuss, amend, update and submit to the JSC for approval: the Development Plan (subject to Section 3.6), including the Joint Development Budget, the TPP, initiate or discontinue any Clinical Trial and any material amendments thereto; review and discuss proposals for new Development Activities pursuant to Section 3.5 and seek input from the JCC; (iv) Decide upon which Party will be responsible for the performance of the various activities set forth in the Development Plan on the basis of Nonclinical Study under each Party’s respective experience, capabilities and capacity as set forth in Section 3.11, including which Party will be the Sponsor of a new Global Trial that is a Joint Development Activity; (v) Oversee the conduct and progress of all Trials required as set forth in the Development Plan, including compliance provided that nothing is intended to limit a Party’s ability to comply with Laws and applicable GLP, GCP and/or GMP standards, mitigation actions, e.g. clinical Trial liaison activities and medical scientific activities, in order to improve Trial recruitment and Trial site engagement and any Development ActivitiesApplicable Law or manage subject safety; (vi) Align with review the Medical Affairs function with regards to Early Access Programs conduct of all Clinical Trials and investigator initiated Nonclinical Studies under each Development Plan, including Required Phase 4 Clinical Trials; (vii) Review and discuss facilitate the progress flow of any Sole Funded information between the Parties with respect to the Development Activityof Licensed Compound; (viii) Coordinate implement and review the overall strategy regarding Regulatory Approval of Licensed Products in the Territory created by Gilead; (ix) discuss Manufacturing, including progress with formulation, validation scaleup, and other activities to maintain supply; * Confidential Information, indicated by […***…], has been omitted from this filing and filed separately with the Securities and Exchange Commission. (x) review the regulatory strategy with respect to discussions with and commitments to or agreements with Regulatory Authorities (including post-approval commitments) with respect to risk management or Required Phase 4 Clinical Trials; (xi) review any material submission to, or any material agreement with or material commitment made to, a Regulatory Authority by Gilead with respect to a Licensed Product, such as any NDA or MAA, or any submission, agreement or commitment with respect to Licensed Product labeling, any risk management plans, any Required Phase 4 Clinical Trial or other post-approval commitment for such Licensed Product, in each case with respect to the Major Markets; (xii) facilitate the exchange flow of information between the Parties under this Agreement regarding the strategy for implementing the Development Activities, including sharing and reviewing of Development Data created pursuant to this Agreement and establishing procedures for the efficient and prompt sharing of information and materials and Know-How reasonably necessary or useful for the Development of the Product in the Territory; (ix) Coordinate and facilitate exchange by both Parties of Regulatory Data and Regulatory Materials in support of filings, facility inspections and Product launch in the Co-Commercialization Territory and the COMPANY Territory; review, discuss and, with respect to Joint Development Activities only, approve the design of the Trial protocols and endpoints; (x) Discuss and agree on the regulatory strategy obtaining Regulatory Approval for filing and maintaining Regulatory Approvals in the Co-Commercialization Territory, in alignment with the JCC; (xi) Review and discuss the regulatory strategy for filing and maintaining Regulatory Approvals in the COMPANY Territory, in alignment with the JCC; (xii) Review and discuss the contents of all submissions to Regulatory Authorities and Governmental Authorities in the Territory for Regulatory Approvals, Regulatory Materials and all necessary filing and registration activities related thereto;Licensed Products; and (xiii) Discuss and agree on all matters related to the maintenance of each Party’s safety database and the global safety database, as applicable; (xiv) Reviewreview, discuss and oversee issues regarding pharmacovigilance coordinate the Parties’ scientific presentation and safety in both the Co-Commercialization Territory and the COMPANY Territory; (xv) Review and provide comments publication strategy relating to the JMC regarding Manufacturing Development Activities and discuss progress and issues concerning Manufacturing Development Activities; (xvi) Review and discuss demand forecasts and timelines of Drug Product for supply of Licensed Products in the Development Activities under the Supply Agreement and report such demand forecasts and timelines to the JMC; (xvii) Discuss and agree the publication strategy for Development Data; (xviii) Review and discuss subcontractors (e.g. contract research organizations, and vendors) and collaboration partners for Joint Development Activities (subject to qualification of such subcontractors in accordance with Laws, GMP and GDP), and report the proposed subcontractors to the JSC for approval; decide on thresholds for seeking the other Party’s approval to engage such subcontractors and partners, and decide which Party (or the Parties) negotiates the respective agreements and signs such agreements with such subcontractor, with the other Party’s prior approval; (xix) Review results of subcontracted Joint Development ActivitiesTerritory.

Specific Responsibilities of the JDC. In addition to its general responsibilities, the The JDC shall in particularhave the following responsibilities: (i) Manage discuss, prepare and oversee submit to the preparation and implementation JSC for approval of the Joint Development PlanPlan (including Joint Development Budget), and all annual and interim amendments to the Joint Development Plan (including Joint Development Budget); (ii) Review, discuss and approve non-material amendments to oversee the conduct of the Joint Development Plan; (iii) Every [***] monthscreate, reviewimplement and review the overall strategy for Development and the design of all Clinical Trials, discuss, amend, update and submit to the JSC for approval: the Development Plan (subject to Section 3.6), including Nonclinical Studies conducted under the Joint Development Budget, the TPP, and any material amendments thereto; review and discuss proposals for new Development Activities pursuant to Section 3.5 and seek input from the JCCPlan; (iv) Decide upon which Party will be responsible for decide when to Initiate or whether or when to discontinue any Clinical Trial and any Nonclinical Study under the performance of the various activities set forth in the Joint Development Plan on the basis of each Plan, and Initiate or discontinue any Clinical Trial and any Nonclinical Study; provided, that nothing is intended to limit a Party’s respective experience, capabilities and capacity as set forth in Section 3.11, including which Party will be the Sponsor of a new Global Trial that is a Joint Development Activityability to comply with Applicable Law or manage subject safety; (v) Oversee in coordination with the conduct JFC, review and progress of all Trials required as set forth propose to the JSC for approval any [**] for inclusion in the applicable Joint Development Plan, including compliance with Laws and applicable GLP, GCP and/or GMP standards, mitigation actions, e.g. clinical Trial liaison activities and medical scientific activities, in order to improve Trial recruitment and Trial site engagement and any Development ActivitiesBudget; (vi) Align with discuss and decide whether to include any Proposed Co-Administration Study in the Medical Affairs function with regards to Early Access Programs Joint Development Plan and investigator initiated TrialsJoint Development Budget, including reviewing and discussing the study plan(s), proposed protocol(s) and budget(s) for such Proposed Co-Administration Study; (vii) Review allocate budgeted resources and discuss determine priorities for each Clinical Trial and Nonclinical Study under the progress Joint Development Plan, and oversee the conduct of any Sole Funded all Clinical Trials and Nonclinical Studies under the Joint Development ActivityPlan; (viii) Coordinate discuss and facilitate the exchange of information coordinate roles and responsibilities between the Parties under this Agreement regarding the strategy for implementing the Development Activities, including sharing and reviewing of Development Data created pursuant to this Agreement and establishing procedures for the efficient and prompt sharing of information and materials and Know-How reasonably necessary or useful for the Development of the Product activities in the Territory; (ix) Coordinate discuss and facilitate exchange by both coordinate roles and responsibilities between the Parties of Regulatory Data and Regulatory Materials in support of filings, facility inspections and Product launch for regulatory activities in the Co-Commercialization Territory Territory, including the Party (which may be different for different activities) responsible for preparing, publishing and the COMPANY Territory; review, discuss and, with respect to Joint Development Activities only, approve the design of the Trial protocols and endpointsfiling applicable Regulatory Materials; (x) Discuss and agree on facilitate the regulatory strategy for filing and maintaining Regulatory Approvals in flow of information between the Co-Commercialization TerritoryParties with respect to the Development of a Licensed Product, in alignment with the JCCincluding any Manufacturing updates; (xi) Review prepare and discuss submit to the regulatory strategy for filing and maintaining Regulatory Approvals JMC the clinical study details of the Licensed Product set forth in the COMPANY Territory, in alignment with the JCCJoint Development Plan for projections of necessary clinical supply quantities; (xii) Review and discuss review the contents overall strategy regarding Regulatory Approval of all submissions to Regulatory Authorities and Governmental Authorities a Licensed Product in the Territory for Regulatory Approvals, Regulatory Materials and all necessary filing and registration activities related thereto;Territory (xiii) Discuss discuss and agree on all designate the Lead Party to lead regulatory matters related to for a Licensed Product in a country or jurisdiction in the maintenance of each Party’s safety database and the global safety database, as applicableTerritory; (xiv) Reviewdiscuss, discuss review and oversee issues regarding pharmacovigilance and safety the conduct of any Clinical Trials in both the Co-Commercialization Territory and the COMPANY Territorythat may be included in a Joint Development Plan; (xv) Review review and provide comments approve terms (other than those set forth in Section 3.10) between a Party and a Third Party subcontractor with respect to the JMC regarding Manufacturing any Development Activities and discuss progress and issues concerning Manufacturing Development Activities;work to be conducted by such subcontractor; and (xvi) Review and discuss demand forecasts and timelines of Drug Product for supply of perform such other functions as directed by the Development Activities under the Supply Agreement and report such demand forecasts and timelines to the JMC; (xvii) Discuss and agree the publication strategy for Development Data; (xviii) Review and discuss subcontractors (e.g. contract research organizations, and vendors) and collaboration partners for Joint Development Activities (subject to qualification of such subcontractors JSC in accordance with Laws, GMP and GDPSection 2.2(c)(xi), and report the proposed subcontractors to the JSC for approval; decide on thresholds for seeking the other Party’s approval to engage such subcontractors and partners, and decide which Party (or the Parties) negotiates the respective agreements and signs such agreements with such subcontractor, with the other Party’s prior approval; (xix) Review results of subcontracted Joint Development Activities.

Specific Responsibilities of the JDC. In addition to its general responsibilities, with respect to Licensed Compounds and the Licensed Product, the JDC shall shall, subject to the terms of this Agreement, in particular: : (ia) Manage and oversee the preparation and implementation of the Development Plan; (ii) Reviewdiscuss, discuss prepare and approve non-material for submission to the JSC amendments to the Development Plan (including the Development Budget and the Regulatory Plan; ); (iiib) Every [***] months, review, discuss, amend, review and update quarterly financial forecasts for Development of the Licensed Product (including timing of expenditures) to endeavor to ensure actual and submit anticipated expenditure is within the approved Development Budget for the relevant Calendar Year and make recommendations to the JSC for approval: approval of any variances before additional expenditures are incurred; (c) create, implement and review the overall strategy for Development of the Licensed Product (including the Regulatory Plan) and the design and objectives of all Clinical Trials and non-clinical studies conducted under the Development Plan; (d) review and approve the protocols for all Clinical Trials conducted under the Development Plan (subject to Section 3.6), including the Joint Development Budget, the TPP, and any material amendments theretothereto (including any amendments which would change the primary endpoint of such Clinical Trial, dosage or similar matters); provided that such review and approval shall be conducted within a timeframe that does not unduly delay any Clinical Trial; (e) review and discuss proposals the Next Generation Compound Notices and related data; (f) decide timing for new Development Activities pursuant filing or withdrawal of any registration application or any submission to Section 3.5 and seek input from the JCC; (iv) Decide upon which Party will be responsible conduct investigative studies for the performance of the various activities set forth in the Development Plan on the basis of each Party’s respective experience, capabilities and capacity as set forth in Section 3.11Licensed Product, including which Party will be the Sponsor of a new Global Trial that is a Joint Development Activity; any IND or MAA; (vg) Oversee oversee the conduct and progress of all Trials required as set forth in any Clinical Trial under the Development Plan, including compliance discuss, coordinate and share information regarding operational activities associated with Laws such Clinical Trials, including study feasibility, study-specific key opinion leader (KOL) engagement, country and applicable GLPsite selection, GCP and/or GMP standardssite contracting, mitigation actionsuse of contract research organizations (including preparation of guidelines with respect to the use of contract research -49- [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, e.g. clinical Trial liaison activities MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED (i) review and medical scientific activitiesdiscuss, in order consultation with the JCC, medical affairs activities for the Licensed Product, including field-based medical education activities by either Party, use of medical liaisons and grant-based medical education programs for Licensed Product, medical affairs materials to improve Trial recruitment be used by the Parties, plans for investigator-initiated studies, and Trial site engagement grant plans; and (ii) discuss, prepare and approve guidelines specifying the content of the Other Field- Based Materials (including, for clarity, with respect to medical liaison and other medical affairs activities) with respect to use of the Licensed Product as a monotherapy or in any Combination Therapy (the “Other Field-Based Materials Guidelines”) and any Development Activities; amendments thereto; provided that the Proprietary Product Party will determine the content of the Other Field-Based Materials Guidelines relating to its Proprietary Product; (vil) Align discuss and approve plans for development of Companion Diagnostics, if any, specifically for use in connection with any Licensed Compound or the Licensed Product; (m) review, discuss and approve, in consultation with the Medical Affairs function with regards to Early Access Programs JCC, strategies for distribution of Licensed Product for “compassionate use” or as free goods; (n) review, discuss, coordinate and investigator initiated Trials; approve a global publication strategy for the Licensed Products (vii) Review and discuss including a strategy for the progress publication of any Sole Funded Development Activity; (viii) Coordinate and facilitate the exchange of information between the Parties Data developed under this Agreement regarding from the strategy for implementing the Development Activities, including sharing and reviewing conduct of Development Data created pursuant to this Agreement and establishing procedures Clinical Trials for the efficient Licensed Products) (“Global Publication Strategy”); (o) discuss, coordinate and prompt sharing of information and materials and Know-How reasonably necessary or useful approve a strategy for the Development of the Licensed Product for use in a Combination Therapy with pharmaceutical product(s) other than the Territory; Initial Merck Proprietary Product (ixincluding testing and conducting Clinical Trials for the Licensed Product for use in a Combination Therapy with [ * ]) Coordinate and facilitate exchange by both Parties reasonably in advance of Regulatory Data and Regulatory Materials in support loss of filings, facility inspections and Product launch in the Co-Commercialization Territory and the COMPANY Territory; review, discuss and, patent exclusivity with respect to Joint Development Activities only, approve the design composition of matter of the Trial protocols and endpoints; Initial Merck Proprietary Product; -50- [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (xI) Discuss and agree on the regulatory strategy for filing and maintaining Regulatory Approvals in the Co-Commercialization Territory, in alignment with the JCC; NOT MATERIAL AND (xiII) Review and discuss the regulatory strategy for filing and maintaining Regulatory Approvals in the COMPANY Territory, in alignment with the JCC; (xii) Review and discuss the contents of all submissions to Regulatory Authorities and Governmental Authorities in the Territory for Regulatory Approvals, Regulatory Materials and all necessary filing and registration activities related thereto; (xiii) Discuss and agree on all matters related to the maintenance of each Party’s safety database and the global safety database, as applicable; (xiv) Review, discuss and oversee issues regarding pharmacovigilance and safety in both the Co-Commercialization Territory and the COMPANY Territory; (xv) Review and provide comments to the JMC regarding Manufacturing Development Activities and discuss progress and issues concerning Manufacturing Development Activities; (xvi) Review and discuss demand forecasts and timelines of Drug Product for supply of the Development Activities under the Supply Agreement and report such demand forecasts and timelines to the JMC; (xvii) Discuss and agree the publication strategy for Development Data; (xviii) Review and discuss subcontractors (e.g. contract research organizations, and vendors) and collaboration partners for Joint Development Activities (subject to qualification of such subcontractors in accordance with Laws, GMP and GDP), and report the proposed subcontractors to the JSC for approval; decide on thresholds for seeking the other Party’s approval to engage such subcontractors and partners, and decide which Party (or the Parties) negotiates the respective agreements and signs such agreements with such subcontractor, with the other Party’s prior approval; (xix) Review results of subcontracted Joint Development Activities.WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED

Specific Responsibilities of the JDC. In addition to its general responsibilities, the JDC shall in particular: (i) Manage monitor, implement, and oversee the preparation Development of the Products through Regulatory Approval in accordance with, and implementation of compare Development progress against, the Development Plan; (ii) Review, discuss and approve non-material amendments approve, for submission to the JSC, any proposed changes, amendments, or other updates to the Development Plan (including the Development Budget) no less than [****], including amendments regarding whether to: conduct additional Pre-Approval Trials of Products for use in the Field in the Territory; develop Products for use in the Field in combination (whether co-administered or co-formulated) with any other active pharmaceutical ingredient or other pharmaceutical product; or discuss and amend the Development Plan (including the Development Budget) to include any Additional Program Plan or Device Program Plan; (iii) Every [***] months, review, discuss, amend, update discuss and submit to the JSC approve a template clinical trial agreement for approval: use in connection with Clinical Trials conducted in accordance with the Development Plan (subject to Section 3.6), including the Joint Development Budget, the TPP, and any material amendments thereto; review and discuss proposals for new Development Activities pursuant to Section 3.5 and seek input from the JCCor Co-Commercialization Plan; (iv) Decide upon which Party will be responsible for the performance of the various activities set forth in review and discuss the Development Plan on the basis of Reports submitted by each Party’s respective experience, capabilities and capacity as set forth in Section 3.11, including which Party will be the Sponsor of a new Global Trial that is a Joint Development Activity; (v) Oversee discuss and approve a regulatory strategy to meet the conduct and progress objectives of all Trials required as set forth the target product profile for Products in the Development Plan, including compliance with Laws and applicable GLP, GCP and/or GMP standards, mitigation actions, e.g. clinical Trial liaison activities and medical scientific activities, Field in order to improve Trial recruitment and Trial site engagement and any Development Activitiesthe Territory; (vi) Align with approve the Medical Affairs function with regards to Early Access Programs Indication, overall study design and investigator initiated Trials; (vii) Review and discuss the progress of dosing, as applicable, for any Sole Funded Development Activity; (viii) Coordinate and facilitate the exchange of information between the Parties under this Agreement regarding the strategy Post-Approval Study for implementing the Development Activities, including sharing and reviewing of Development Data created pursuant to this Agreement and establishing procedures for the efficient and prompt sharing of information and materials and Know-How reasonably necessary or useful for the Development of the any Product in the Territory; (ixvii) Coordinate and facilitate exchange by both Parties prior to initiation of Regulatory Data and Regulatory Materials in support of filings, facility inspections and any Phase 3 Clinical Trial for a Product launch for use in the Co-Commercialization Territory and the COMPANY Territory; reviewField, discuss and, with respect to Joint Development Activities only, approve the design of the Trial protocols and endpoints[****]; (xviii) Discuss approve (subject to the timing requirement set forth in the last sentence of Section 3.7(b)) the initiation of [****]; (ix) following completion of the Phase 3 Clinical Trial for a Product or Indication in the Field, review and agree on approve the regulatory Regulatory Approval strategy (including label strategy, label negotiation strategy and any proposed changes thereto, for filing and maintaining Regulatory Approvals use in the Co-Commercialization Territory, ) therefor; (x) approve the initial submission of an NDA and major labeling updates for a Product for use in alignment with the JCCField to the FDA; (xi) Review and discuss the regulatory strategy if applicable, develop a plan for filing and maintaining Regulatory Approvals an Expanded Access Program with respect to Products for use in the COMPANY Field in the Territory, in alignment with the JCC; (xii) Review and discuss the contents of all submissions to Regulatory Authorities and Governmental Authorities in the Territory for Regulatory Approvals, Regulatory Materials and all necessary filing and registration activities related thereto;[****]; and (xiii) Discuss and agree on all matters related perform such other functions as may be appropriate to further the maintenance purposes of each Party’s safety database and the global safety databasethis Agreement, as applicable; (xiv) Review, discuss and oversee issues regarding pharmacovigilance and safety in both the Co-Commercialization Territory and the COMPANY Territory; (xv) Review and provide comments to the JMC regarding Manufacturing Development Activities and discuss progress and issues concerning Manufacturing Development Activities; (xvi) Review and discuss demand forecasts and timelines of Drug Product for supply of the Development Activities under the Supply Agreement and report such demand forecasts and timelines to the JMC; (xvii) Discuss and agree the publication strategy for Development Data; (xviii) Review and discuss subcontractors (e.g. contract research organizations, and vendors) and collaboration partners for Joint Development Activities (subject to qualification of such subcontractors in accordance with Laws, GMP and GDP), and report the proposed subcontractors to directed by the JSC for approval; decide on thresholds for seeking or as expressly specified in this Agreement. For clarity, the JDC shall have no responsibility or authority other Party’s approval to engage such subcontractors and partners, and decide which Party (or the Parties) negotiates the respective agreements and signs such agreements with such subcontractor, with the other Party’s prior approval; (xix) Review results of subcontracted Joint Development Activitiesthan that expressly set forth in this Agreement.

Specific Responsibilities of the JDC. In addition to its general responsibilities, the JDC shall in particular: (i) Manage review and discuss applicable Development Plans and material amendments and updates to such Development Plans, including, with respect to the U.S., the U.S. Development Budget, and strategy for Development set forth therein, and present such Development Plans to the JSC for the JSC’s review and approval; (ii) work with the JFC to develop and review budgets for Development Plans; (iii) provide regular reports to the JSC regarding the Development of the Products; (iv) discuss and manage the implementation of the initial Development Plans; (v) oversee the preparation conduct of Development in the Territory, including all Clinical Trials and implementation nonclinical studies; (vi) create, implement and review the design of all Clinical Trials and nonclinical studies conducted under each Development Plan; (vii) establish trial/project-specific addenda to the U.S. Development Plan that will set forth applicable Development FTE Rates and an allocation of time by such Development FTEs to be spent on such activities; (viii) decide whether and when to initiate or discontinue any Clinical Trial and any nonclinical study under each Development Plan; (ix) determine the amount of Product to be distributed free of charge annually for regulatory or Clinical Trials, including investigator-initiated trials; (x) allocate budgeted resources and determine priorities for each Clinical Trial and nonclinical study under each Development Plan; (xi) facilitate the flow of information between the Parties with respect to the Development of Products, including with respect to obtaining Regulatory Approval for Products; (xii) discuss whether to Develop Products for new Indications and propose any such Indications to the JSC; (xiii) allocate primary responsibility as between the Parties for tasks relating to Development of Products in or for the U.S. where not already specified in the Development Plan; (iixiv) Review, discuss the requirements for Regulatory Approval in the Territory and approve non-material amendments to the Development Plan; (iii) Every [***] months, review, discuss, amend, update and submit to the JSC for approval: the Development Plan (subject to Section 3.6)oversee regulatory matters, including the Joint Development Budget, the TPP, and any material amendments thereto; review and discuss proposals for new Development Activities pursuant to Section 3.5 and seek input from the JCC; (iv) Decide upon which Party will be responsible for the performance of the various activities set forth in the Development Plan on the basis of each Party’s respective experience, capabilities and capacity as set forth in Section 3.11, including which Party will be the Sponsor of a new Global Trial that is a Joint Development Activity; (v) Oversee the conduct and progress of all Trials required as set forth in the Development Plan, including compliance with Laws and applicable GLP, GCP and/or GMP standards, mitigation actions, e.g. clinical Trial liaison activities and medical scientific activities, in order to improve Trial recruitment and Trial site engagement and any Development Activities; (vi) Align with the Medical Affairs function with regards to Early Access Programs and investigator initiated Trials; (vii) Review and discuss the progress of any Sole Funded Development Activity; (viii) Coordinate and facilitate the exchange of information between the Parties under this Agreement regarding the strategy for implementing the Development Activities, including sharing and reviewing of Development Data created pursuant to this Agreement and establishing procedures for the efficient and prompt sharing of information and materials and Know-How reasonably necessary or useful for the Development of the Product in the Territory; (ix) Coordinate and facilitate exchange by both Parties of Regulatory Data and Regulatory Materials in support of filings, facility inspections and Product launch in the Co-Commercialization Territory and the COMPANY Territory; review, discuss and, regulatory communication strategies with respect to Joint Development Activities only, approve the design of the Trial protocols and endpoints; (x) Discuss and agree on the regulatory strategy for filing and maintaining Regulatory Approvals in the Co-Commercialization Territory, in alignment with the JCC; (xi) Review and discuss the regulatory strategy for filing and maintaining Regulatory Approvals in the COMPANY Territory, in alignment with the JCC; (xii) Review and discuss the contents of all submissions to Regulatory Authorities and Governmental Authorities Products in the Territory for in conjunction with the regulatory department of the Party which holds or will hold the relevant Regulatory Approvals, Regulatory Materials and all necessary filing and registration activities related thereto; (xiii) Discuss and agree on all matters related to the maintenance of each Party’s safety database and the global safety database, as applicable; (xiv) Review, discuss and oversee issues regarding pharmacovigilance and safety in both the Co-Commercialization Territory and the COMPANY TerritoryApproval; (xv) Review establish a publication strategy for publications and provide comments presentations related to the JMC regarding Manufacturing Development Activities and discuss progress and issues concerning Manufacturing Development Activities;Product in the Territory in cooperation with the JCC; and (xvi) Review and discuss demand forecasts and timelines perform such other functions as may be appropriate to further the purposes of Drug Product for supply of this Agreement, as directed by the Development Activities under the Supply Agreement and report such demand forecasts and timelines to the JMC; (xvii) Discuss and agree the publication strategy for Development Data; (xviii) Review and discuss subcontractors (e.g. contract research organizations, and vendors) and collaboration partners for Joint Development Activities (subject to qualification of such subcontractors in accordance with Laws, GMP and GDP), and report the proposed subcontractors to the JSC for approval; decide on thresholds for seeking the other Party’s approval to engage such subcontractors and partners, and decide which Party (or the Parties) negotiates the respective agreements and signs such agreements with such subcontractor, with the other Party’s prior approval; (xix) Review results of subcontracted Joint Development ActivitiesJSC.

Specific Responsibilities of the JDC. In addition to its general responsibilities, the The JDC shall in particularhave the following responsibilities: (i) Manage and oversee the preparation and implementation of the Transition Plans with respect to Development activities, including costs associated with such activities; (ii) discuss, review and approve the Lead Product Development Plan (including Joint Development Cost Budget), and all annual and interim amendments to the Lead Product Development Plan (including Joint Development Cost Budget); ​ ​ (iii) oversee the conduct of the Lead Product Development Plan, including lifecycle planning; (iv) create, implement and review the overall strategy for Development and the design of all Clinical Trials, Nonclinical Studies and pre-clinical studies conducted under the Lead Product Development Plan; (iiv) Reviewdecide whether and when to initiate or discontinue any Clinical Trial and any Nonclinical Study under the Lead Product Development Plan, discuss and approve non-material amendments initiate or discontinue any Clinical Trial and any Nonclinical Study, provided that nothing is intended to limit a Party’s ability to comply with Applicable Law or manage subject safety; (vi) allocate budgeted resources and determine priorities for each Clinical Trial and Nonclinical Study under the Lead Product Development Plan, and oversee the conduct of all Clinical Trials and Nonclinical Studies under the Lead Product Development Plan; (iiivii) Every [***] months, review, discuss, amend, update discuss and submit to coordinate roles and responsibilities between the JSC Parties for approval: the Development Plan (subject to Section 3.6), including the Joint Development Budget, the TPP, and any material amendments thereto; review and discuss proposals for new Development Activities pursuant to Section 3.5 and seek input from the JCC; (iv) Decide upon which Party will be responsible for the performance of the various activities set forth in the Development Plan on the basis of each Party’s respective experience, capabilities and capacity as set forth in Section 3.11, including which Party will be the Sponsor of a new Global Trial that is a Joint Development Activity; (v) Oversee the conduct and progress of all Trials required as set forth in the Development Plan, including compliance with Laws and applicable GLP, GCP and/or GMP standards, mitigation actions, e.g. clinical Trial liaison activities and medical scientific activities, in order to improve Trial recruitment and Trial site engagement and any Development Activities; (vi) Align with the Medical Affairs function with regards to Early Access Programs and investigator initiated Trials; (vii) Review and discuss the progress of any Sole Funded Development ActivityTerritory; (viii) Coordinate and facilitate the exchange flow of information between the Parties under this Agreement regarding the strategy for implementing the Development Activities, including sharing and reviewing of Development Data created pursuant with respect to this Agreement and establishing procedures for the efficient and prompt sharing of information and materials and Know-How reasonably necessary or useful for the Development of the Lead Product, including any Manufacturing updates; (ix) review the overall strategy regarding Regulatory Approval of the Lead Product in the Territory; (ixx) Coordinate discuss, review and facilitate exchange by both Parties oversee the conduct of Regulatory Data and Regulatory Materials in support of filings, facility inspections and Product launch any Phase 4 Clinical Trials in the Co-Commercialization Territory and the COMPANY Territory; review, discuss and, with respect to Joint that may be included in a Development Activities only, approve the design of the Trial protocols and endpoints; (x) Discuss and agree on the regulatory strategy for filing and maintaining Regulatory Approvals in the Co-Commercialization Territory, in alignment with the JCCPlan; (xi) Review discuss, review and discuss the regulatory strategy for filing and maintaining Regulatory Approvals in the COMPANY Territory, in alignment with the JCCapprove any Supplemental Studies; (xii) Review discuss, review and discuss the contents decide whether to initiate Development of all submissions a Diagnostic Test or Biomarker to support Regulatory Authorities and Governmental Authorities in the Territory for Regulatory Approvals, Regulatory Materials and all necessary filing and registration activities related theretoApproval or Commercialization of a Licensed Product pursuant to Section 3.14; (xiii) Discuss discuss, review and agree on all matters related to approve the maintenance initiation of each Party’s safety database any activities under a Second Generation Research Plan in accordance with Section 3.13 (and any amendments thereto), oversee the global safety database, as applicableactivities under such Second Generation Research Plan [***]; (xiv) Review, discuss and oversee issues regarding pharmacovigilance and safety in both the Co-Commercialization Territory and the COMPANY Territory[***]; (xv) Review discuss, review and provide comments approve any Early Program Development Plan (including and following Roche’s exercise of its Option Right pursuant to Section 3.13, the JMC regarding Manufacturing Early Program Development Activities and discuss progress and issues concerning Manufacturing Cost Budget for such Early Program Development Activities;Plan) consistent with the foregoing clauses (ii) through (xi);and (xvi) Review and discuss demand forecasts and timelines of Drug Product for supply of perform such other functions as directed by the Development Activities under the Supply Agreement and report such demand forecasts and timelines to the JMC; (xvii) Discuss and agree the publication strategy for Development Data; (xviii) Review and discuss subcontractors (e.g. contract research organizations, and vendors) and collaboration partners for Joint Development Activities (subject to qualification of such subcontractors JSC in accordance with Laws, GMP and GDPSection 2.2(c)(vi), and report the proposed subcontractors . References to Clinical Trials in clauses (iv) through (vi) shall be deemed to include only those Phase 4 Clinical Trials that the JSC for approval; decide on thresholds for seeking has directed to be undertaken by the other Party’s approval to engage such subcontractors and partners, and decide which Party (or JDC instead of the Parties) negotiates the respective agreements and signs such agreements with such subcontractor, with the other Party’s prior approval; (xix) Review results of subcontracted Joint Development Activities.JMAC. ​ ​