Common use of Specific Responsibilities of the JSC Clause in Contracts

Specific Responsibilities of the JSC. The responsibilities of the JSC will be to: (a) oversee the overall strategic relationship between the Parties; (b) review, discuss, and approve each Research Plan (including the applicable Research Budget set forth therein), and each amendment or update thereto; (c) review, discuss, develop, and approve the Success Criteria (or any modification thereto) for Candidates that Modulate each Target; (d) review and discuss each Interim Report, each Success Criteria Report, and the Exploratory Research Report; (e) review, discuss, and determine whether any Candidate identified in the Success Criteria Report has achieved the Success Criteria for Candidates that Modulate such Target; (f) facilitate the flow of information (including Development Reports) between the Parties with respect to the Development and Commercialization of Ophthalmic Candidates, Ophthalmic Products, [***] Candidates in the Ex-Vivo Field, and [***] Products in the Ex-Vivo Field; (g) review and discuss any proposed sublicenses to whom NVS proposes to grant rights to Develop or Commercialize In-Vivo [***] Products; (h) review and discuss the Development Plan for In-Vivo [***] Products and all material amendments or updates thereto; (i) develop, discuss, and approve the initial high-level summary (including the associated budget) of marketing strategy and Commercialization activities for In-Vivo [***] Products, and each material amendment or update to such plans and budgets; (j) review, discuss, and approve the Global In-Vivo [***] Commercialization Plan and the U.S. In-Vivo [***] Commercialization Plan (including the applicable Commercialization Budgets set forth therein), and all material amendments or updates to such plans and budgets; (k) review and discuss the status and progress of regulatory activities for In-Vivo [***] Products and provide any comments to NVS with respect to any Jointly-Agreed Regulatory Submissions for In-Vivo [***] Products; (l) review, discuss, and approve each Global Medical Affairs Plan and U.S. Medical Affairs Plan, progress under such plans, and all material amendments or updates thereto; (m) review, discuss, and approve the initial Global Brand Plan for In-Vivo [***] Products, and each material amendment and update thereto; (n) upon request of a Party, develop and discuss whether to approve a Territory-specific brand plan for U.S. [***] Products; (o) review, discuss and coordinate the Parties’ scientific presentation and publication strategy relating to In-Vivo [***] Products in the Territory; (p) review and discuss reports from the JMC and provide guidance to any Subcommittee to resolve any other disputes or disagreements arising from any such Subcommittee; (q) establish additional subcommittees, and other operational committees or ad hoc subcommittees, on an “as needed” basis to oversee particular projects or activities (the JMC, and such other operational committees and subcommittees, each a “Subcommittee”); and (r) perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties.

Specific Responsibilities of the JSC. The responsibilities of In addition to its general responsibilities, the JSC will be toshall in particular: (a) oversee the overall strategic relationship between the Parties; (b) review, discuss, and approve each Research Plan (including the applicable Research Budget set forth therein), and each amendment or update thereto; (c) review, discuss, develop, and approve the Success Criteria (or any modification thereto) for Candidates that Modulate each Target; (d) review and discuss each Interim Report, each Success Criteria Report, and the Exploratory Research Report; (e) review, discuss, and determine whether any Candidate identified in the Success Criteria Report has achieved the Success Criteria for Candidates that Modulate such Target; (f) facilitate the flow of information (including Development Reports) between the Parties with respect to the Development and Commercialization of Ophthalmic Candidates, Ophthalmic Products, [***] Candidates in the Ex-Vivo Field, and [***] Products in the Ex-Vivo Field; (g) review and discuss any proposed sublicenses to whom NVS proposes to grant rights to Develop or Commercialize In-Vivo [***] Products; (h) review and discuss the Development Plan for In-Vivo [***] Products and all material amendments or updates thereto; (i) developDiscuss and decide upon the overall strategy for Developing, discussCommercializing and Manufacturing the Licensed Antibody and Product in both the Co-Commercialization Territory and the COMPANY Territory, including approval of the Development Plan, Joint Development Budget, the TPP, the overall strategy for seeking Regulatory Approvals and approve Pricing Approvals, the initial highCo-level summary (Commercialization Plan, the Co-Commercialization Budget and including discussing and reviewing the associated budget) of marketing strategy and Commercialization activities for In-Vivo [***] Products, and each material amendment or update to such plans and budgets; (j) review, discuss, and approve the Global In-Vivo [***] COMPANY Commercialization Plan and the U.S. In-Vivo [***] approval of alignment of COMPANY Commercialization Plan (including with the applicable Commercialization Budgets set forth therein)overall strategic Product positioning, branding, core messaging, and all material amendments or updates to such plans overall medical congress strategy and budgets; (k) review and discuss the status and progress of regulatory activities for In-Vivo [***] Products and provide any comments to NVS global medical education strategy with respect to any Jointly-Agreed Regulatory Submissions for In-Vivo [***] Products; (l) review, discuss, and approve each Global Medical Affairs Plan and U.S. Medical Affairs Plan, progress under such plans, and all material amendments or updates thereto; (m) review, discuss, and approve the initial Global Brand Plan for In-Vivo [***] Products, and each material amendment and update thereto; (n) upon request of a Party, develop and discuss whether to approve a Territory-specific brand plan for U.S. [***] Products; (o) review, discuss and coordinate the Parties’ scientific presentation and publication strategy relating to In-Vivo [***] Products global Commercialization in the Territory; (pii) review Approve the COMPANY Commercialization Plan, the Co-Commercialization Plan and discuss reports from the JMC Co-Commercialization Budget, and provide guidance to any Subcommittee to resolve any other disputes or disagreements arising from any such Subcommitteeupdates and amendments thereto; (qiii) establish Approve additional subcommitteesGlobal Trials, including Independent Trials, and other operational committees material amendments of the Development Plan, including the determination of proposed new Development activities as either Joint Development Activity or ad hoc subcommitteesSole Funded Development Activity, on subject to Section 3.5; (iv) Approve the strategic aspects of material Regulatory Activities and material Pricing Activities in the Territory; (v) Discuss and decide upon the overall global strategy for Commercializing the Product and material Pricing Activities in both the Co-Commercialization Territory and the COMPANY Territory; (vi) Discuss and decide responsibility for the Common Technical Document (CTD); (vii) Consider in good faith any reasonable concerns of a Party that a Sole Funded Development Activity or investigator initiated Trial might adversely affect in a material way the value proposition of Licensed Antibody or Product, by, as non-limiting examples, positioning Licensed Antibody or Product in a niche or addressing a significant number of patients that would otherwise be treated within the label of an “as needed” basis to oversee particular projects or activities already existing Regulatory Approval for Product; (viii) Review and approve COMPANY’s demand and sales forecasts for the COMPANY Territory and the Parties’ demand and sales forecast for the Co-Commercialization Territory and the respective timelines after reconciliation by the JMC, ; (ix) Discuss and such other operational committees approve a potential Technology Transfer and subcommittees, each a “Subcommittee”the related supply chain strategy after discussion of the same in the JMC; (x) Discuss and review new in-license agreements for Third Party licenses in accordance with Section 8.4(a) and 8.4(b); and (rxi) perform Oversee the JDC, JMC, JCC and Finance Working Group (as defined in Section 7.8), approve proposals, plans and Pre-Tax Profit (Loss) Share calculation methodology presented by these committees or group and decide upon issues, which these committees referred to the JSC pursuant to Section 9.5(e), Section 9.6(e), Section 9.7(e) or Section 7.8 and coordinate matters that affect more than one of such other functions as appropriate to further the purposes of this Agreement as determined by the Partiescommittees.

Specific Responsibilities of the JSC. The responsibilities On an R&D Program-by-R&D Program basis and subject to Section 3.1.5, the JSC shall be responsible for overseeing the entire collaboration between GSK and KineMed during the applicable R&D Program. Without limiting the foregoing, the JSC shall perform the following functions, some or all of which may be addressed directly at any given meeting of the JSC will be toJSC: (a) oversee the overall strategic relationship between the Parties; (b) reviewa. Review, discuss, and approve each Research Plan (including the applicable Research Budget set forth therein), and each amendment or update thereto; (c) review, discuss, developcomment on, and approve the Success Criteria (or Research Plan and Pharmacological Validation Plan for each R&D Program on an annual basis and from time-to-time on an ad hoc basis as requested by the Parties, including any modification updates and amendments thereto) for Candidates that Modulate each Target; (d) review b. Oversee the implementation of the Research Plan and discuss Pharmacological Validation Plan for each Interim Report, R&D Program and each Success Criteria Report, and the Exploratory Research Report; (e) review, discuss, and determine whether any Candidate identified in the Success Criteria Report has achieved the Success Criteria for Candidates that Modulate such Target; (f) facilitate the flow of information (including Development Reports) between the Parties Party’s progress with respect to the Development activities allocated to such Party under the applicable Research Plan; c. On an R&D Program-by-R&D Program basis, review and Commercialization of Ophthalmic Candidatesapprove the Clinical Fluid Biomarker Criteria and Clinical Tissue Biomarker Criteria and propose modifications or amendments thereto; review and approve the Tissue Biomarker Criteria and Fluid Biomarker Criteria for the Fibrosis Application and review any modifications or amendments to the Tissue Biomarker Criteria and Fluid Biomarker Criteria; d. On an R&D Program-by-R&D Program basis, Ophthalmic Productsdetermine whether the applicable milestone events have been achieved, [provided that any disputes ***] Candidates in the Ex-Vivo Field, and [***] Products in the Ex-Vivo Field; (g) review and discuss e. Resolve any proposed sublicenses disputes or other matters raised to whom NVS proposes to grant rights to Develop or Commercialize In-Vivo [***] Productsthe JSC from any Subcommittee established hereunder; (h) review f. Provide a forum for the Parties to exchange information and discuss the Development Plan for In-Vivo [***] Products and all material amendments or updates thereto; (i) develop, discuss, and approve the initial high-level summary (including the associated budget) of marketing strategy and Commercialization coordinate their respective activities for In-Vivo [***] Products, and each material amendment or update to such plans and budgets; (j) review, discuss, and approve the Global In-Vivo [***] Commercialization Plan and the U.S. In-Vivo [***] Commercialization Plan (including the applicable Commercialization Budgets as set forth therein)in this Agreement; and EXECUTION COPY Confidential g. Perform such other duties as are specifically assigned to the JSC in this Agreement or otherwise agreed to in writing by the Parties; provided, and all material amendments however, that in no event shall the Joint Steering Committee have any authority to (x) resolve any disputes involving the breach or updates alleged breach of this Agreement, (y) amend any allocation of costs between the Parties, or require either Party to such plans and budgets; expend additional resources, whether internal or external, except as stated under this Agreement, or (kz) review and discuss the status and progress of regulatory activities for In-Vivo [***] Products and provide any comments to NVS with respect to any Jointly-Agreed Regulatory Submissions for In-Vivo [***] Products; (l) reviewotherwise amend or modify this Agreement, discuss, and approve each Global Medical Affairs Plan and U.S. Medical Affairs Plan, progress under such plans, and all material amendments or updates thereto; (m) review, discuss, and approve the initial Global Brand Plan for In-Vivo [***] Products, and each material amendment and update thereto; (n) upon request of a Party, develop and discuss whether to approve a Territory-specific brand plan for U.S. [***] Products; (o) review, discuss and coordinate the Parties’ scientific presentation respective rights and publication strategy relating to In-Vivo [***] Products in the Territory; (p) review and discuss reports from the JMC and provide guidance to any Subcommittee to resolve any other disputes or disagreements arising from any such Subcommittee; (q) establish additional subcommittees, and other operational committees or ad hoc subcommittees, on an “as needed” basis to oversee particular projects or activities (the JMC, and such other operational committees and subcommittees, each a “Subcommittee”); and (r) perform such other functions as appropriate to further the purposes of this Agreement as determined by the Partiesobligations hereunder.

Specific Responsibilities of the JSC. The responsibilities Without limiting any of the foregoing, subject to Sections 2.1.7 and 2.2.2, the JSC will shall perform the following functions for any given Program, some or all of which may be toaddressed directly at any given meeting of the JSC: (a) oversee the overall strategic relationship between the PartiesReview [...***...] each Research Plan and any amendments thereto as it relates to either an Initial Collaboration Target or a Subsequent Collaboration Target; (b) reviewConfirm that the Discovery Milestone has been achieved for a Program, discuss, and approve each Research Plan (including the applicable Research Budget set forth therein), and each amendment or update thereto[...***...]; (c) review, discussupdate [...***...] (upon unanimous agreement of the Parties) the Candidate Selection Criteria within [...***...] days of recommendation by the JPS, developincluding any amendments thereto proposed by either Party (through the JPS, and approve the Success Criteria (JSC or any modification thereto) for Candidates that Modulate each Targetotherwise); (d) review and discuss each Interim Report, each Success amend ([...***...] of the Parties) the Candidate Selection Criteria Report, and the Exploratory Research Reportfrom time to time; (e) review, discuss, and determine confirm ([...***...] of the Parties) whether any a Collaboration Compound meets the Candidate identified in the Success Criteria Report has achieved the Success Criteria for Candidates that Modulate such TargetSelection Criteria; (f) facilitate the flow of information (including Development Reports) between the Parties with respect to the Development and Commercialization of Ophthalmic Candidatesreview, Ophthalmic Products, update [...***...] Candidates in (upon unanimous agreement of the Ex-Vivo FieldParties) the (i) design and content of the PoC Criteria, (ii) Target Product Profile upon which such PoC Criteria was based, and (iii) design, content and endpoints of the PoC Trial, in each case within [...***...] Products days of recommendation by the JPS, including any amendments to the PoC Criteria design and content, Target Profit Profile or PoC Trial design, content and endpoints which may be proposed by either Party (through the JPS, JSC or otherwise), each of (i), (ii) and (iii) shall be subject to GSK final decision-making authority as described in the Ex-Vivo FieldSection 2.1.7(b); (g) review the overall progress of Regulus’ efforts to discover, identify, optimize and discuss any proposed sublicenses to whom NVS proposes to grant rights to otherwise Develop or Commercialize In-Vivo Collaboration Compounds under each Program, including review and [...***...] Productsof any proposal for termination of a Program; (h) review and discuss the Development Plan for In-Vivo [...***...] Products and all material amendments or updates theretothe Development of any Collaboration Compound for the treatment of any potential additional Indications; (i) developreview, discuss, and approve the initial high-level summary (including the associated budget) of marketing strategy and Commercialization activities for In-Vivo update [...***...] Products(upon unanimous agreement of the Parties) the Initial Research Plan, the Research Plans and, if applicable, the Early Development Plans, including any technical changes or amendments thereto which may be proposed by either Party (through the JPS, JSC or otherwise) to reflect [...***...], with the aim of achieving the [...***...] Criteria and each material amendment or update to such plans and budgets[...***...] Criteria; (j) reviewdiscuss and attempt to resolve (by unanimous agreement of the Parties) any deadlock issues submitted to it by any Subcommittee, discuss, and approve including the Global In-Vivo resolution of any disputes regarding [...***] Commercialization Plan and the U.S. In-Vivo [***] Commercialization Plan (including the applicable Commercialization Budgets set forth therein), and all material amendments or updates to such plans and budgets;...]; and (k) review and discuss such other responsibilities as may be assigned to the status and progress JSC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time; provided, however, that in no event shall the JSC have any authority to (x) resolve any disputes involving the breach or alleged breach of regulatory activities for In-Vivo [***] Products and provide this Agreement, (y) amend any comments budget or allocation of costs between the Parties, or require either Party to NVS with respect expend additional resources, whether internal or external, except as stated under this Agreement pursuant to any Jointly-Agreed Regulatory Submissions for In-Vivo [***] Products; the exercise of discretionary authority expressly granted to the JSC or (lz) review, discuss, and approve each Global Medical Affairs Plan and U.S. Medical Affairs Plan, progress under such plans, and all material amendments otherwise amend or updates thereto; (m) review, discuss, and approve the initial Global Brand Plan for In-Vivo [***] Products, and each material amendment and update thereto; (n) upon request of a Party, develop and discuss whether to approve a Territory-specific brand plan for U.S. [***] Products; (o) review, discuss and coordinate modify this Agreement or the Parties’ scientific presentation respective rights and publication strategy relating to In-Vivo [***] Products in the Territory; (p) review and discuss reports from the JMC and provide guidance to any Subcommittee to resolve any other disputes or disagreements arising from any such Subcommittee; (q) establish additional subcommittees, and other operational committees or ad hoc subcommittees, on an “as needed” basis to oversee particular projects or activities (the JMC, and such other operational committees and subcommittees, each a “Subcommittee”); and (r) perform such other functions as appropriate to further the purposes of this Agreement as determined by the Partiesobligations hereunder.

Specific Responsibilities of the JSC. The responsibilities of the JSC will be to: (a) oversee the overall strategic relationship between the Parties; (b) review, discuss, and approve each Research Plan (including the applicable Research Budget set forth therein), and each amendment or update thereto; (c) review, discuss, develop, and approve the Success Criteria (or any modification thereto) for Candidates that Modulate each Target; (d) review and discuss each Interim Report, each Success Criteria Report, and the Exploratory Research Report; (e) review, discuss, and determine whether any Candidate identified in the Success Criteria Report has achieved the Success Criteria for Candidates that Modulate such Target; (f) facilitate the flow of information (including Development Reports) between the Parties with respect to the Development and Commercialization of Ophthalmic Candidates, Ophthalmic Products, [***] Sickle Cell Candidates in the Ex-Vivo Field, and [***] Sickle Cell Products in the Ex-Vivo Field; (g) review and discuss any proposed sublicenses to whom NVS proposes to grant rights to Develop or Commercialize In-Vivo [***] SCD Products; (h) review and discuss the Development Plan for In-Vivo [***] SCD Products and all material amendments or updates thereto; (i) develop, discuss, and approve the initial high-level summary (including the associated budget) of marketing strategy and Commercialization activities for In-Vivo [***] SCD Products, and each material amendment or update to such plans and budgets; (j) review, discuss, and approve the Global In-Vivo [***] SCD Commercialization Plan and the U.S. In-Vivo [***] SCD Commercialization Plan (including the applicable Commercialization Budgets set forth therein), and all material amendments or updates to such plans and budgets; (k) review and discuss the status and progress of regulatory activities for In-Vivo [***] SCD Products and provide any comments to NVS with respect to any Jointly-Agreed Regulatory Submissions for In-Vivo [***] SCD Products; (l) review, discuss, and approve each Global Medical Affairs Plan and U.S. Medical Affairs Plan, progress under such plans, and all material amendments or updates thereto; (m) review, discuss, and approve the initial Global Brand Plan for In-Vivo [***] SCD Products, and each material amendment and update thereto; (n) upon request of a Party, develop and discuss whether to approve a Territory-specific brand plan for U.S. [***] SCD Products; (o) review, discuss and coordinate the Parties’ scientific presentation and publication strategy relating to In-Vivo [***] SCD Products in the Territory; (p) review and discuss reports from the JMC and provide guidance to any Subcommittee to resolve any other disputes or disagreements arising from any such Subcommittee; (q) establish additional subcommittees, and other operational committees or ad hoc subcommittees, on an “as needed” basis to oversee particular projects or activities (the JMC, and such other operational committees and subcommittees, each a “Subcommittee”); and (r) perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties.

Specific Responsibilities of the JSC. The responsibilities of In addition to its overall responsibility for monitoring and providing strategic oversight and overseeing the Collaboration, the JSC will be toshall in particular: (ai) oversee the overall strategic relationship between Collaboration, including the PartiesDevelopment, Manufacture, Commercialization and Medical Affairs Activities of Licensed Compound and Licensed Products in the Territory and any other ongoing activities under this Agreement; (b) review, discuss, and approve each Research Plan (including the applicable Research Budget set forth therein), and each amendment or update thereto; (c) review, discuss, develop, and approve the Success Criteria (or any modification thereto) for Candidates that Modulate each Target; (d) review and discuss each Interim Report, each Success Criteria Report, and the Exploratory Research Report; (e) review, discuss, and determine whether any Candidate identified in the Success Criteria Report has achieved the Success Criteria for Candidates that Modulate such Target; (fii) facilitate the flow of information (including Development Reports) between the Parties with respect to the Development Development, Manufacture, Commercialization and Commercialization Medical Affairs Activities of Ophthalmic Candidates, Ophthalmic Products, [***] Candidates in the Ex-Vivo Field, Licensed Compound and [***] Products in the Ex-Vivo Field; (g) review and discuss any proposed sublicenses to whom NVS proposes to grant rights to Develop or Commercialize In-Vivo [***] Licensed Products; (hiii) review oversee the activities of the JDC, JCC, JMAC, JMC, JFC, IPOC and discuss the Development Plan for In-Vivo [***] Products any other Committee and all material amendments or updates provide guidance thereto; (iiv) develop, discuss, review and approve the initial high-level summary Joint Development Plan (including the associated budget) of marketing strategy and Commercialization activities for In-Vivo [***] ProductsJoint Development Budget), and each material amendment or update all annual and interim amendments to such plans and budgetsthe Joint Development Plan (including Joint Development Cost); (jv) review, discuss, review and approve the Global In-Vivo [***] Commercialization Supply Plan; (vi) discuss, review and approve the Joint Medical Affairs Plan (including the budget related thereto) and all annual and interim amendments to such Joint Medical Affairs Plan (including the U.S. In-Vivo [***] budget related thereto); (vii) discuss, review and approve the Joint Commercialization Plan (including the applicable Joint Commercialization Budgets set forth therein), Budget) and all material annual and interim amendments or updates to such plans and budgetsJoint Commercialization Plan (including Joint Commercialization Budget); (kviii) review reviewing and discuss the status and progress of regulatory activities for In-Vivo approving any [***] Products and provide any comments to NVS with respect to any Jointly-Agreed Regulatory Submissions for In-Vivo [***] Products]; (lix) review, discussdecide whether to enter into, and review and approve each Global Medical Affairs Plan and U.S. Medical Affairs Planthe terms of, progress under such plans, and all material amendments or updates theretoa Third Party License; (mx) review, discuss, discuss and approve the initial Global Brand Plan for In-Vivo [***] Products, and each material amendment and update theretodetermine Single Party Designation; (nxi) upon request of a Partyattempt to resolve issues presented to it by, develop and discuss whether to approve a Territory-specific brand plan for U.S. [***] Productsdisputes within, the JDC, JCC, JMC, JMAC, JFC, IPOC and any other Committee; (oxii) review, discuss and coordinate the Parties’ scientific presentation and publication strategy relating to In-Vivo [***] Products in the Territory; (p) review and discuss reports from the JMC and provide guidance to any Subcommittee to resolve any other disputes or disagreements arising from any such Subcommittee; (qaccordance with Section 2.2(f) establish such additional subcommittees, Committees as it deems necessary to achieve the objectives and other operational committees or ad hoc subcommittees, on an “as needed” basis to oversee particular projects or activities (the JMC, and such other operational committees and subcommittees, each a “Subcommittee”)intent of this Agreement; and (rxiii) perform such other functions as appropriate appropriate, and direct each other Committee to perform such other functions as appropriate, to further the purposes of this Agreement Agreement, in each case as determined agreed in writing by the Parties.

Specific Responsibilities of the JSC. The responsibilities of In addition to its overall responsibility for coordinating the Parties’ activities under this Agreement, the JSC will be toshall, in particular and in a timely manner: (ai) oversee monitor progress of the overall strategic relationship between Development of the PartiesProduct in the Field in the Territory, including the Ongoing Lilly Trials; (bii) reviewreview and, discussas further described in Section 6.2, comment upon the Commercialization Plan, and approve each Research Plan (including the applicable Research Budget set forth therein), and each amendment all updates or update amendments thereto; (ciii) reviewreview and comment upon plans for Development of the Product in the Field, discussincluding clinical trial protocols, developmonitoring plans, and approve the Success Criteria (data disclosure plans included with each such protocol, and all updates or any modification amendments thereto) for Candidates that Modulate each Target; (div) review any and discuss each Interim Reportall clinical trials, each Success Criteria Reportincluding audit plans with respect thereto, conducted by United Therapeutics with respect to the Product in the Field in the Territory and conducted by Lilly with respect to the Exploratory Research ReportOngoing Lilly Trials; (ev) review, discuss, review any and determine whether any Candidate identified in the Success Criteria Report has achieved the Success Criteria for Candidates that Modulate such Targetall audit reports and action plans with respect thereto provided by United Therapeutics pursuant to Section 5.2(d); (fvi) review confirmation of United Therapeutics’ completion of any monitoring and quality oversight actions required to be taken pursuant to this Agreement; (vii) review any serious and/or persistent site non-compliance issues that affect patient safety and/or data integrity along with the corrective action plan, each to the extent regarding the Product in the Field in the Territory; (viii) facilitate the flow of information with respect to the Commercialization of the Product in the Field in the Territory by United Therapeutics and Commercialization of the Product in the Field outside the Territory by Lilly, where such information is Useful to the other Party; (including Development Reportsix) facilitate mechanisms for discussion between the Parties with respect to submission of Regulatory Filings for the Product in the Field in the Territory, including processes for preparing Regulatory Filings for the Product in the Field in the Territory consistent with Lilly’s standard operating procedures; (x) facilitate mechanisms for discussion between the Parties with respect to Development of the Product in the Field, including the contents and submission of Regulatory Filings, to the extent such Development and such Regulatory Filings are Useful to United Therapeutics or to Lilly; (xi) facilitate communication between the Parties with respect to all serious adverse events or significant safety issues for products which contain the Compound in all fields throughout the world to the extent such information is Useful to United Therapeutics or to Lilly, consistent with the terms of the Safety Agreement and coordinate efforts of the Parties to ensure proper reporting of all Adverse Events for the Product in the Field in the Territory in accordance with Applicable Law and consistent with the terms of the Safety Agreement; (xii) facilitate the flow of information with respect to any material new studies of which either Party becomes aware which relate to the Product in the Field (whether inside or outside of the Territory); (xiii) facilitate the flow of publicly available information with respect to any material studies of which either Party becomes aware which relate to any Competitive Product controlled by a Third Party in the Field throughout the world, in either case to the extent such information is Useful to United Therapeutics or to Lilly; (xiv) facilitate the flow of information with respect to any material studies being conducted by Lilly which relate to products which contain the Compound outside the Field throughout the world, to the extent such information would be reasonably likely to materially adversely affect the Product in United Therapeutics’ Domain; (xv) implement policies and procedures for providing United Therapeutics with copies of all correspondence and communications with Regulatory Authorities relating to products which contain the Compound in PAH, and in the event that United Therapeutics pursues any Secondary Indication with the approval of Lilly as described in Section 5.2(i), such Secondary Indication, to the extent such correspondence and communications are Useful to United Therapeutics; (xvi) implement policies and procedures for providing United Therapeutics with updates regarding all correspondence and communications with Regulatory Authorities relating to products which contain the Compound in all fields throughout the world other than PAH, and in the event that United Therapeutics pursues any Secondary Indication with the approval of Lilly as described in Section 5.2(i), such Secondary Indication, to the extent such correspondence and communications are reasonably likely to materially adversely affect the Product; (xvii) coordinate the availability, timing, and amount of placebo to be supplied by Lilly to United Therapeutics for the Development of the Product in the Field in the Territory and for supply of the Product in the Field in the Territory, and procedures for forecasting and ordering such placebo and Product pursuant to the Manufacturing and Supply Agreement; (xviii) monitor Lilly’s manufacturing capacity for the Product for use in the Field in the Territory pursuant to the Manufacturing and Supply Agreement; (xix) establish subcommittees as needed to address issues in the Development and Commercialization of Ophthalmic Candidates, Ophthalmic Products, [***] Candidates the Product in the Ex-Vivo Field, and [***] Products in the Ex-Vivo Field; (g) review and discuss any proposed sublicenses to whom NVS proposes to grant rights to Develop or Commercialize In-Vivo [***] Products; (h) review and discuss the Development Plan for In-Vivo [***] Products and all material amendments or updates thereto; (i) develop, discuss, and approve the initial high-level summary (including the associated budget) of marketing strategy and Commercialization activities for In-Vivo [***] Products, and each material amendment or update to such plans and budgets; (j) review, discuss, and approve the Global In-Vivo [***] Commercialization Plan and the U.S. In-Vivo [***] Commercialization Plan (including the applicable Commercialization Budgets set forth therein), and all material amendments or updates to such plans and budgets; (k) review and discuss the status and progress of regulatory activities for In-Vivo [***] Products and provide any comments to NVS with respect to any Jointly-Agreed Regulatory Submissions for In-Vivo [***] Products; (l) review, discuss, and approve each Global Medical Affairs Plan and U.S. Medical Affairs Plan, progress under such plans, and all material amendments or updates thereto; (m) review, discuss, and approve the initial Global Brand Plan for In-Vivo [***] Products, and each material amendment and update thereto; (n) upon request of a Party, develop and discuss whether to approve a Territory-specific brand plan for U.S. [***] Products; (o) review, discuss and coordinate the Parties’ scientific presentation and publication strategy relating to In-Vivo [***] Products Field in the Territory; (p) review , and discuss reports from the JMC and provide guidance to any Subcommittee to resolve any other address disputes or disagreements arising from in any such Subcommittee; (q) establish additional subcommittees, and other operational committees or ad hoc subcommittees, on an “as needed” basis to oversee particular projects or activities (the JMC, and such other operational committees and subcommittees, each a “Subcommittee”)subcommittee so established; and (rxx) perform such other functions as appropriate to further the purposes of this Agreement as determined by the PartiesParties may agree in writing.

Specific Responsibilities of the JSC. The responsibilities of JSC shall have the JSC will be tofollowing responsibilities: (ai) develop and approve the Research Plan and Research Budget for the second Program Target and third Program Target; (ii) review, discuss and approve updates or amendments to each Research Plan and Research Budget; (iii) oversee the overall strategic relationship between conduct and performance of each Program during the PartiesResearch Term; (biv) reviewfor each Program, discussdiscuss the progress of the Research Plan and any interim Results; (v) determine whether or not to use any Third Party intellectual property in the conduct of a Research Plan; (vi) discuss whether or not a particular iADC is a DC Compound; (vii) discuss whether to select DC Compounds for further Development and Commercialization; (viii) discuss the progress of Development of each Cost Share Option Product and Cost Share Product; (ix) discuss and decide whether or not a Cost Share Option Product and Cost Share Product may be Developed as part of a Combination Product in the United States; (x) [*]; (xi) for each Licensed Product for which Astellas is planning to conduct a Pivotal Study, discuss the anticipated initial Cost Share Development Plan and Cost Share Development Budget for such Licensed Product; (xii) oversee the co-promotion (including Promotion compliance) of each CoPro Product in the United States, if any; (xiii) review and approve each Research update to a Cost Share Development Plan and Cost Share Development Budget; (including the applicable Research Budget set forth therein)xiv) review and approve each Cost Share Commercialization Plan and Cost Share Commercialization Budget, and each amendment or any update thereto; (cxv) review, discuss, develop, discuss timing and approve the Success Criteria (or any modification thereto) coordination of each Manufacturing Technology Transfer and clinical supply manufacturing for Candidates that Modulate each TargetLicensed Product; (dxvi) review and discuss each Interim Report, each Success Criteria Report, and the Exploratory Research Report[*]; (exvii) review, discuss, establish and determine whether any Candidate identified in the Success Criteria Report has achieved the Success Criteria for Candidates that Modulate such Targetoversee subcommittees; (fxviii) facilitate the flow of information (including Development Reports) between the Parties with respect resolve all matters that are in dispute as escalated to the Development and Commercialization of Ophthalmic Candidates, Ophthalmic Products, [***] Candidates in the Ex-Vivo Field, and [***] Products in the Ex-Vivo Field; (g) review and discuss any proposed sublicenses to whom NVS proposes to grant rights to Develop or Commercialize In-Vivo [***] Products; (h) review and discuss the Development Plan for In-Vivo [***] Products and all material amendments or updates thereto; (i) develop, discuss, and approve the initial high-level summary (including the associated budget) of marketing strategy and Commercialization activities for In-Vivo [***] Products, and each material amendment or update to such plans and budgets; (j) review, discuss, and approve the Global In-Vivo [***] Commercialization Plan and the U.S. In-Vivo [***] Commercialization Plan (including the applicable Commercialization Budgets set forth therein), and all material amendments or updates to such plans and budgets; (k) review and discuss the status and progress of regulatory activities for In-Vivo [***] Products and provide any comments to NVS with respect to any Jointly-Agreed Regulatory Submissions for In-Vivo [***] Products; (l) review, discuss, and approve each Global Medical Affairs Plan and U.S. Medical Affairs Plan, progress under such plans, and all material amendments or updates thereto; (m) review, discuss, and approve the initial Global Brand Plan for In-Vivo [***] Products, and each material amendment and update thereto; (n) upon request of JSC by a Party, develop and discuss whether to approve a Territory-specific brand plan for U.S. [***] Products; (o) review, discuss and coordinate the Parties’ scientific presentation and publication strategy relating to In-Vivo [***] Products in the Territory; (p) review and discuss reports from the JMC and provide guidance to any Subcommittee to resolve any other disputes or disagreements arising from any such Subcommittee; (q) establish additional subcommittees, and other operational committees or ad hoc subcommittees, on an “as needed” basis to oversee particular projects or activities (the JMC, and such other operational committees and subcommittees, each a “Subcommittee”)subcommittee; and (rxix) perform such other functions as appropriate to further the purposes of expressly set forth in this Agreement or as determined otherwise agreed by the PartiesParties in writing.

Specific Responsibilities of the JSC. The responsibilities Without limiting any of the foregoing, subject to Sections 2.1.7 and 2.2.2, the JSC will shall perform the following functions for any given Program, some or all of which may be toaddressed directly at any given meeting of the JSC: (a) oversee the overall strategic relationship between the PartiesReview [***] each Research Plan and any amendments thereto as it relates to either an Initial Collaboration Target or a Subsequent Collaboration Target; (b) reviewConfirm that the Discovery Milestone has been achieved for a Program, discuss, and approve each Research Plan (including the applicable Research Budget set forth therein), and each amendment or update thereto[***]; (c) review, discussupdate [***] (upon unanimous agreement of the Parties) the Candidate Selection Criteria within [***] days of recommendation by the JPS, developincluding any amendments thereto proposed by either Party (through the JPS, and approve the Success Criteria (JSC or any modification thereto) for Candidates that Modulate each Targetotherwise); (d) review and discuss each Interim Report, each Success amend ([***] of the Parties) the Candidate Selection Criteria Report, and the Exploratory Research Reportfrom time to time; (e) review, discuss, and determine confirm ([***] of the Parties) whether any a Collaboration Compound meets the Candidate identified in the Success Criteria Report has achieved the Success Criteria for Candidates that Modulate such TargetSelection Criteria; (f) facilitate the flow of information (including Development Reports) between the Parties with respect to the Development and Commercialization of Ophthalmic Candidatesreview, Ophthalmic Products, update [***] Candidates (upon unanimous agreement of the Parties) the (i) design and content of the PoC Criteria, (ii) Target Product Profile upon which such PoC Criteria was based, and (iii) design, content and endpoints of the PoC Trial, in each case within [***] days of recommendation by the ExJPS, including any amendments to the PoC Criteria design and content, Target Profit Profile or PoC Trial design, content and endpoints which may be proposed by either Party (through the JPS, JSC or otherwise), each of (i), (ii) and (iii) shall be subject to GSK final decision-Vivo Fieldmaking authority as described in Section 2.1.7(b); (g) review the overall progress of Regulus’ efforts to discover, identify, optimize and otherwise Develop Collaboration Compounds under each Program, including review and [***] Products in the Ex-Vivo Field; (g) review and discuss of any proposed sublicenses to whom NVS proposes to grant rights to Develop or Commercialize In-Vivo [***] Productsproposal for termination of a Program; (h) review and discuss the Development Plan for In-Vivo [***] Products and all material amendments or updates theretothe Development of any Collaboration Compound for the treatment of any potential additional Indications; (i) developreview, discuss, and approve the initial high-level summary (including the associated budget) of marketing strategy and Commercialization activities for In-Vivo update [***] Products(upon unanimous agreement of the Parties) the Initial Research Plan, the Research Plans and, if applicable, the Early Development Plans, including any technical changes or amendments thereto which may be proposed by either Party (through the JPS, JSC or otherwise) to reflect [***], with the aim of achieving the [***] Criteria and each material amendment or update to such plans and budgets[***] Criteria; (j) reviewdiscuss and attempt to resolve (by unanimous agreement of the Parties) any deadlock issues submitted to it by any Subcommittee, discuss, and approve including the Global In-Vivo resolution of any disputes regarding [***] Commercialization Plan and the U.S. In-Vivo [***] Commercialization Plan (including the applicable Commercialization Budgets set forth therein), and all material amendments or updates to such plans and budgets;]; and (k) review and discuss such other responsibilities as may be assigned to the status and progress JSC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time; provided, however, that in no event shall the JSC have any authority to (x) resolve any disputes involving the breach or alleged breach of regulatory activities for In-Vivo [***] Products and provide this Agreement, (y) amend any comments budget or allocation of costs between the Parties, or require either Party to NVS with respect expend additional resources, whether internal or external, except as stated under this Agreement pursuant to any Jointly-Agreed Regulatory Submissions for In-Vivo [***] Products; the exercise of discretionary authority expressly granted to the JSC or (lz) review, discuss, and approve each Global Medical Affairs Plan and U.S. Medical Affairs Plan, progress under such plans, and all material amendments otherwise amend or updates thereto; (m) review, discuss, and approve the initial Global Brand Plan for In-Vivo [***] Products, and each material amendment and update thereto; (n) upon request of a Party, develop and discuss whether to approve a Territory-specific brand plan for U.S. [***] Products; (o) review, discuss and coordinate modify this Agreement or the Parties’ scientific presentation respective rights and publication strategy relating to In-Vivo [***] Products in the Territory; (p) review and discuss reports from the JMC and provide guidance to any Subcommittee to resolve any other disputes or disagreements arising from any such Subcommittee; (q) establish additional subcommittees, and other operational committees or ad hoc subcommittees, on an “as needed” basis to oversee particular projects or activities (the JMC, and such other operational committees and subcommittees, each a “Subcommittee”); and (r) perform such other functions as appropriate to further the purposes of this Agreement as determined by the Partiesobligations hereunder.

Specific Responsibilities of the JSC. The responsibilities of the JSC will be to: (a) oversee manage the overall strategic alignment between the Parties under this Agreement and maintain the relationship between the Parties; (b) review, discuss, and approve each Research Plan (including the applicable Research Budget set forth therein), and each amendment or update theretodetermine whether to [***]; (c) review, discuss, develop, and approve the Success Criteria (or any modification thereto) for Candidates that Modulate each Targetdetermine whether [***]; (d) review and discuss each Interim Reportreview, each Success Criteria Reportdiscuss, and the Exploratory Research Reportdetermine whether [***]; (e) review, discuss, and determine whether any Candidate identified in the Success Criteria Report has achieved the Success Criteria for Candidates that Modulate such Target[***]; (f) facilitate the flow of information (including Development Reports) between the Parties with respect to the Development review, discuss and Commercialization of Ophthalmic Candidates, Ophthalmic Products, determine whether [***] Candidates in the Ex-Vivo Field, and [***] Products in the Ex-Vivo Field]; (g) review and discuss any proposed sublicenses to whom NVS proposes to grant rights to Develop or Commercialize In-Vivo [***] Products; (h) review and discuss the Development Plan for In-Vivo [***] Products and all material amendments or updates thereto; (i) develop, discuss, and approve the initial high-level summary (including the associated budget) of marketing strategy and Commercialization activities for In-Vivo [***] Products, and each material amendment or update to such plans and budgets; (j) review, discuss, and determine whether to approve the Global In-Vivo [***] Commercialization Plan and the U.S. In-Vivo [***] Commercialization Plan (including the applicable Commercialization Budgets set forth therein), and all material amendments or any updates to such plans and budgetsthe Shared Development Budget, as described in Section 4.4.2(a) (Shared Development Budget); (k) review and discuss the status and progress of regulatory activities for In-Vivo [***] Products and provide any comments to NVS with respect to any Jointly-Agreed Regulatory Submissions for In-Vivo [***] Products; (lh) review, discuss, and determine whether to approve [***] and the Shared Development Budget, as described in Section 4.4.4(a) (Shared Costs); (i) share information related to, and review and discuss activities and progress of each Global Medical Affairs Plan Party in connection with the Development of Licensed Products in its Territory, including activities and U.S. Medical Affairs progress under the Cross-Territory Clinical Development Plan, progress under such plansNon-Clinical HAE Development Plan, and all material amendments the Otsuka Territory-Specific Development Plan, including through updates from each Party of the status of Development for the Licensed Products in each Party’s Territory, as described in Section 4.5 (Development Reports); (j) review and discuss any matters related to the Development of the Licensed Products referred to the JSC by either Party’s representatives; (k) discuss any concerns raised by either Party regarding any action that the other Party is taking or updates theretointends to take with respect to a Licensed Product that is [***], as described in Section 5.8 (No Harmful Actions); (l) discuss [***]; (m) review, discuss, and determine whether to approve the initial Global Brand Plan for In-Vivo [***] Products, and each material amendment and update thereto]; (n) upon request of a Partyreview, develop discuss, and discuss determine whether to approve a Territory-specific brand plan for U.S. [***] Products]; (o) review, discuss discuss, and coordinate the Parties’ scientific presentation and publication strategy relating determine whether to In-Vivo approve [***] Products in the Territory]; (p) review review, discuss and discuss reports from the JMC and provide guidance determine whether to any Subcommittee to resolve any other disputes or disagreements arising from any such Subcommitteeapprove [***]; (q) establish additional subcommittees, review and other operational committees or ad hoc subcommittees, on an “as needed” basis discuss any matters related to oversee particular projects or activities (the JMC, and such other operational committees and subcommittees, each a “Subcommittee”); and (r) perform such other functions as appropriate Commercialization of the Licensed Products referred to further the purposes of this Agreement as determined JSC by the Parties.either Party’s representatives;

Specific Responsibilities of the JSC. The responsibilities of the JSC will be to: (a) oversee Discuss and approve the overall strategic relationship between the PartiesScreening Plan and any amendments thereto; (b) review, discuss, Manage the overall Research collaboration alignment between the Parties under this Agreement and approve each Research Plan (including maintain the applicable Research Budget set forth therein), and each amendment or update theretorelationship; (c) reviewSelect and decide on the Target Pairs (and any replacements thereof) based on ArriVent’s nomination and available information, discuss, develop, and approve including the Success Criteria (or any modification thereto) for Candidates that Modulate each Targetscreening results; (d) review Discuss and discuss each Interim Reportapprove the Research Plan, each Success Criteria Report, ArriVent Directed Research and the Exploratory Research Reportany amendments thereto; (e) review, discuss, Discuss and determine whether any Candidate identified in decide the Success Criteria Report has achieved the Success Criteria for Candidates that Modulate such Targetdesign and process of Compounds and Products during Research stage; (f) facilitate Discuss the flow Research results; (g) Discuss and approve the costs and expenses budget on screening activities and budget on Research activities in excess of [***] of the Research Budget; (h) Discuss and approve the costs and expenses budget on Development activities within and for the ArriVent Territory and Dual Territory Study; (i) Supervise on the performance of the Supply Agreements; (j) Report and discuss the Development Plan and any updates thereto; (k) Report and share information for Development activities in the Alphamab Territory; (l) Report and share information for the regulatory and Commercialization strategy of the Product within ArriVent Territory and the Alphamab Territory; (m) Discuss any concerns raised by either Party regarding any action that the other Party is taking or intends to take with respect to any Product that is likely to have a material adverse effect upon the regulatory status of any Product in the other Party’s Territory; (n) Forming any subcommittee as it or the Parties deem appropriate or necessary, deciding the scope of responsibilities of any subcommittee, supervising the subcommittees and making decisions resolving matters submitted by any subcommittee in accordance with Article 3.8; (o) Review and discuss patenting and Intellectual Property Right protection strategies for Products and other Joint New IP; 5 / 55 (p) Facilitate access to and the exchange of information (including Development Reports) between the Parties with respect pursuant to this Agreement and any Ancillary Agreements, including the exchange of relevant information and data between the Parties (i) as required for the performance of any rights or obligations and (ii) related to the Development and Commercialization of Ophthalmic Candidates, Ophthalmic Products, [***] Candidates in the Ex-Vivo Field, and [***] Products in the Ex-Vivo Field; (g) review and discuss any proposed sublicenses to whom NVS proposes to grant rights to Develop or Commercialize In-Vivo [***] Products; (h) review and discuss the Development Plan for In-Vivo [***] Products and all material amendments or updates thereto; (i) develop, discuss, and approve the initial high-level summary (including the associated budget) of marketing strategy and Commercialization activities for In-Vivo [***] Products, and each material amendment or update to such plans and budgets; (j) review, discuss, and approve the Global In-Vivo [***] Commercialization Plan and the U.S. In-Vivo [***] Commercialization Plan (including the applicable Commercialization Budgets set forth therein), and all material amendments or updates to such plans and budgets; (k) review and discuss the status and progress of regulatory activities for In-Vivo [***] Products and provide any comments to NVS with respect to any Jointly-Agreed Regulatory Submissions for In-Vivo [***] Products; (l) review, discuss, and approve each Global Medical Affairs Plan and U.S. Medical Affairs Plan, progress under such plans, and all material amendments or updates thereto; (m) review, discuss, and approve the initial Global Brand Plan for In-Vivo [***] Products, and each material amendment and update thereto; (n) upon request of a Party, develop and discuss whether to approve a Territory-specific brand plan for U.S. [***] Products; (o) review, discuss and coordinate Territory by the Parties’ scientific presentation and publication strategy relating to In-Vivo [***] Products in the Territory; (p) review and discuss reports from the JMC and provide guidance to any Subcommittee to resolve any other disputes or disagreements arising from any such Subcommittee; (q) establish additional subcommittees, and other operational committees or ad hoc subcommittees, on an “Establish procedures for Publications as needed” basis to oversee particular projects or activities (the JMC, and such other operational committees and subcommittees, each a “Subcommittee”)set forth in Article 11; and (r) perform such Such other functions responsibilities as appropriate may be assigned to further the purposes of JSC pursuant to this Agreement as determined by the Partiesand any Ancillary Agreement.