Common use of JSC Roles and Responsibilities Clause in Contracts

JSC Roles and Responsibilities. The responsibilities of the JSC will be to: (a) provide a forum for the discussion of the Parties’ activities under this Agreement; (b) review and discuss matters that Kiniksa believes may have a Material Adverse Impact on the Licensed Product; (c) review and discuss Partner’s engagement of Subcontractors that are not Preapproved Subcontractors, as described in Section 2.2.3 (Right to Subcontract); (d) establish and oversee the JDC and JMC and settle any disputes that arise within the JDC or JMC, as described in Section 3.6.2 (Resolution of JDC and JMC Disputes); (e) oversee the implementation of, and the coordination between the Parties of activities to be performed under, the Clinical Supply Agreement, the Commercial Supply Agreement, the Safety Agreements, and any other written agreement between the Parties with respect to the subject matter hereof; (f) determine the appropriate time to perform the Manufacturing Technology Transfer for the Licensed Product, which in all cases will be conducted with sufficient time ​ ​ so that Partner can be the Marketing Authorization Holder for the Licensed Product throughout the Territory, either (i) to those CMOs selected by Partner to Manufacture the Licensed Product for use by Partner in the Territory (which CMOs Partner will engage), or (ii) if agreed by the JSC for the Licensed Product, to Partner, as described in Section 4.2 (Manufacturing Technology Transfer). (g) if the Manufacturing Technology Transfer for the Licensed Product will be to Partner (and not one or more CMOs), review, discuss, and determine whether to approve (i) the Manufacturing Technology Transfer Plan for the Licensed Product and (ii) any change in the scope of Manufacturing activities to be transferred to Partner if agreed by the JSC in connection with the Manufacturing Technology Transfer for the Licensed Product, each as described in Section 4.2 (Manufacturing Technology Transfer); (h) review, discuss, and determine whether to approve any updates to the Territory Development Plan for the Licensed Product, in each case, as described in Section 5.2.1 (Territory Clinical Development); (i) [***]; (j) review, discuss, and determine whether to approve any material updates to, the Global Development Plan for the Licensed Product with respect to activities to be conducted by Partner in the Territory, including Partner’s participation in the conduct of any Global Clinical Trial, each as described in Section 5.3 (Global Development Plan); (k) review and discuss if Partner will be the Territory Sponsor for Global Clinical Trials to be conducted under the Global Development Plan (as set forth therein), as described in Section 5.3 (Global Development Plan); provided that Partner will have the right, following such review and discussion, to make such determination; (l) review, discuss, and determine whether to add any countries in the Territory as Selected Territory GCT Countries for a given Global Clinical Trial to be conducted under the Global Development Plan, as described in Section 5.3 (Global Development Plan); (m) determine the total number of patients to be enrolled in the Territory for a given Global Clinical Trial, as contemplated in the applicable protocol for such Global Clinical Trial, as described in Section 5.3 (Global Development Plan); (n) review, discuss, and determine whether to approve any New Development Proposal, and review, discuss, and determine whether to approve any New Territory-Specific Development Activities, in each case, as described in Section 5.4 (New Development by Partner); (o) discuss the status, progress, and results of the Parties’ respective Development activities, as described in Section 5.10 (Development Reports); (p) review, discuss, and determine whether to approve the regulatory strategy for receipt of Regulatory Approval in each country or region in the Territory, as described in Section 6.1 (Regulatory Strategy); ​ ​ (q) review and discuss Partner’s plan for undertaking additional regulatory activities for the Licensed Product delegated by Kiniksa or the JSC to Partner, as described in Section 6.2.1 (Obtaining and Maintaining Regulatory Approvals); (r) review and discuss the transfer of the Manufacturing of the Licensed Product (or any component thereof) in the Territory to one or more CMOs in the Territory selected by Partner, as described in Section 6.2.1 (a) (Local Manufacturing); (s) review, discuss, and determine whether to permit Partner to Manufacture the Licensed Product in the Territory itself, instead of through one or more CMOs selected by Partner, as described in Section 6.2.1 (a) (Local Manufacturing); (t) review, discuss, and determine whether to approve Partner’s plan for undertaking any activities and interactions relating to obtaining and maintaining Local Manufacturing Approvals for the Licensed Product in the Territory, as described in Section 6.2.1 (a) (Local Manufacturing); (u) review, discuss, and determine whether to approve any Regulatory Submissions that are in the name of Kiniksa, as described in Section 6.2.3 (Review of Regulatory Submissions); (v) facilitate the Parties’ review and updating of Partner Process and Specifications and develop a plan for remediation of any deficiencies or limitations with respect to such Partner Process and Specifications, as described in Section 7.2.4 (Process and Specifications); (w) review, discuss, and determine whether to approve Medical Affairs Plans for the Territory and any updates thereto for the Licensed Product, as described in Section 8.1 (Medical Affairs Plan); (x) review, discuss, and determine whether to approve the Commercialization Plan for the Territory and any updates thereto for the Licensed Product, as described in Section 9.2 (Commercialization Plan); (y) review, discuss, and determine whether to approve any brand strategy for the Licensed Product that is specific to the Territory (or any country or region therein) and that is inconsistent with the Global Brand Strategy for the Licensed Product, as described in Section 9.2 (Commercialization Plan); (z) review, discuss, and determine whether to approve the use of any Product Xxxx for the Licensed Product in the Territory that deviates from Kiniksa’s Global Brand Elements, as described in Section 14.9.2 (Product Marks in the Territory); and (aa) perform such other functions as expressly set forth in this Agreement or allocated to the JSC by the Parties’ written agreement.

JSC Roles and Responsibilities. The responsibilities of the JSC will be to: (a) provide a forum for the discussion of the Parties’ activities under this Agreement; (b) review and discuss matters that Kiniksa believes may have a Material Adverse Impact on the Development and Manufacturing of the Licensed ProductProduct both inside and outside of the Territory for Commercialization purposes in the Field in the Territory (including any material changes to the Current Phase III Protocols), and Commercialization of the Licensed Product in the Field in the Territory; (c) review and discuss Partner’s engagement of Subcontractors that are not Preapproved Subcontractorsthe protocol for the Post-Marketing Activities, and review, discuss, and determine whether to approve the Post-Marketing Budget and any update thereto or overrun thereof, in each case, as described in Section 2.2.3 3.1.2 (Right to SubcontractPost-Marketing Activities); (d) establish review, discuss, and oversee determine whether to approve the JDC and JMC and settle plan for the performance of any disputes Additional Development to be performed in the event that arise within Torii does not terminate the JDC or JMCAgreement in accordance with Section 13.2.1(a), as described in Section 3.6.2 4.1.3 (Resolution of JDC and JMC DisputesAdditional Development); (e) review, discuss, and determine whether to approve the conduct of (i) any Development activities for the Licensed Product proposed by Torii for purposes of Commercializing the Licensed Product in the Field in the Territory or (ii) any Investigator Initiated Clinical Development, and determine whether to allocate to Torii responsibility for any Torii Development Activities, in each case, as described in Section 4.1.4 (Other Development); (f) oversee the implementation of, and the coordination between the Parties of activities to be performed under, the Clinical Supply Agreement, the Commercial Supply Agreement, the Safety SDE Agreements, and any other written agreement between the Parties with respect to the subject matter hereofLicensed Product in the Field in the Territory; (fg) determine the appropriate time to perform the Manufacturing Technology Transfer review and discuss a detailed timeline for the Licensed Product, which in all cases will be conducted with sufficient time ​ ​ so that Partner can be transfer of the Marketing Authorization Holder for the Licensed Product throughout the Territory, either (i) to those CMOs selected by Partner to Manufacture the Licensed Product for use by Partner in the Territory (which CMOs Partner will engage), or (ii) if agreed by the JSC for the Licensed Product, to PartnerAssigned Regulatory Materials and each Party’s roles and responsibilities therefor, as described in Section 4.2 3.4 (Manufacturing Technology Transfer). (g) if the Manufacturing Technology Transfer for the Licensed Product will be to Partner (and not one or more CMOs), review, discuss, and determine whether to approve (i) the Manufacturing Technology Transfer Plan for the Licensed Product and (ii) any change in the scope of Manufacturing activities to be transferred to Partner if agreed by the JSC in connection with the Manufacturing Technology Transfer for the Licensed Product, each as described in Section 4.2 (Manufacturing Technology TransferRegulatory Materials); (h) discuss and determine whether Torii will perform any Territory-Specific Packaging and Labeling, as described in Section 5.1.3 (Territory-Specific Packaging and Labeling); (i) review, discuss, and determine whether to approve the Commercialization Plan (including the Performance Targets set forth therein) and any updates to the Territory Development Plan for the Licensed Product, in each casethereto, as described in Section 5.2.1 6.3 (Territory Clinical DevelopmentCommercialization Plans); (ij) [***]review and discuss any request by Torii that BioCryst apply for a Product Xxxx that is used or intended be used in the Field in the Territory, as described in Section 6.9.4 (Torii’s Rights for Trademarks); (jk) review, discuss, and determine whether to approve any matters in the Territory that may have a material updates to, adverse impact upon the Global Development Plan for regulatory status of the Licensed Product with respect to activities to be conducted by Partner in outside the Territory, including Partner’s participation in the conduct of any Global Clinical Trial, each Territory as described provided in Section 5.3 7.6 (Global Development PlanNo Harmful Actions); (k) review and discuss if Partner will be the Territory Sponsor for Global Clinical Trials to be conducted under the Global Development Plan (as set forth therein), as described in Section 5.3 (Global Development Plan); provided that Partner will have the right, following such review and discussion, to make such determination; (l) review, discuss, and determine whether to add any countries in the Territory as Selected Territory GCT Countries for a given Global Clinical Trial to be conducted under the Global Development Plan, as described in Section 5.3 (Global Development Plan); (m) determine the total number of patients to be enrolled in the Territory for a given Global Clinical Trial, as contemplated in the applicable protocol for such Global Clinical Trial, as described in Section 5.3 (Global Development Plan); (n) review, discuss, Publication and determine whether to approve any New Development Proposal, and review, discuss, and determine whether to approve any New Territory-Specific Development Activities, in each case, as described in Section 5.4 (New Development by Partner); (o) discuss the status, progress, and results of the Parties’ respective Development activities, as described in Section 5.10 (Development Reports); (p) review, discuss, and determine whether to approve the regulatory strategy for receipt of Regulatory Approval in each country or region in the Territory, as described in Section 6.1 (Regulatory Strategy); ​ ​ (q) review and discuss Partner’s plan for undertaking additional regulatory activities for the Licensed Product delegated by Kiniksa or the JSC to Partner, as described in Section 6.2.1 (Obtaining and Maintaining Regulatory Approvals); (r) review and discuss the transfer of the Manufacturing of the Licensed Product (or any component thereof) in the Territory to one or more CMOs in the Territory selected by Partner, as described in Section 6.2.1 (a) (Local Manufacturing); (s) review, discuss, and determine whether to permit Partner to Manufacture the Licensed Product in the Territory itself, instead of through one or more CMOs selected by Partner, as described in Section 6.2.1 (a) (Local Manufacturing); (t) review, discuss, and determine whether to approve Partner’s plan for undertaking any activities and interactions relating to obtaining and maintaining Local Manufacturing Approvals for the Licensed Product in the Territory, as described in Section 6.2.1 (a) (Local Manufacturing); (u) review, discuss, and determine whether to approve any Regulatory Submissions that are in the name of Kiniksa, as described in Section 6.2.3 (Review of Regulatory Submissions); (v) facilitate the Parties’ review and updating of Partner Process and Specifications and develop a plan for remediation of any deficiencies or limitations with respect to such Partner Process and Specifications, as described in Section 7.2.4 (Process and Specifications); (w) review, discuss, and determine whether to approve Medical Affairs Plans for the Territory Communication Strategy and any updates thereto for the Licensed Product, as described in Section 8.1 9.6 (Medical Affairs PlanPublications); (xm) review, discuss, and determine whether to approve the Commercialization Plan for the Territory FTE Rate and any updates update thereto for prior to the Licensed Product, as described in Section 9.2 (Commercialization Plan)commencement of any relevant activities under this Agreement that require reimbursement at the FTE Rate; (yn) reviewserve as a forum to receive updates on market access, discussreimbursement, and determine whether to approve any brand pricing strategy for the Licensed Product that is specific to the Territory (or any country or region therein) and that is inconsistent with the Global Brand Strategy for the Licensed Product, as described in Section 9.2 (Commercialization Plan); (z) review, discuss, and determine whether to approve the use of any Product Xxxx for the Licensed Product in the Territory that deviates from Kiniksa’s Global Brand Elements, as described in Section 14.9.2 (Product Marks Field in the Territory); (o) establish and dissolve any subcommittee or working group to discuss specific matters under this Agreement; and (aap) perform such other functions as expressly set forth in this Agreement or allocated to the JSC by the Parties’ written agreement.

JSC Roles and Responsibilities. The responsibilities of the JSC will be to: (a) provide a forum for the discussion of the Parties’ activities under this Agreement; (b) review and discuss matters that Kiniksa a Party believes may have a Material Adverse Impact safety impact on the any Licensed ProductProduct in such Party’s territory; (c) review review, discuss, and discuss Partner’s engagement determine whether to approve the initial list of Subcontractors that are not Preapproved Subcontractors[***] and any updates thereto, as described in Section 2.2.3 (Right to Subcontract)) and (ii) the engagement of any CSO that is not a [***]; (d) establish and oversee the JDC JDC, [***], and JMC JCC, and settle any disputes that arise within the JDC JDC, [***], or JMCJCC, as described in Section 3.6.2 3.7.2 (Resolution of JDC JDC, [***], and JMC JCC Disputes); (e) oversee the implementation of, and the coordination between the Parties of activities to be performed under, the Clinical Supply Agreement, the Commercial Supply Agreement, the Safety Agreements, and any other written agreement between the Parties with respect to the subject matter hereof; (f) review, discuss, and determine the appropriate time whether to perform the Manufacturing Technology Transfer for the Licensed Product, which in all cases will be conducted with sufficient time ​ ​ so that permit Partner can be the Marketing Authorization Holder for to [***] the Licensed Product throughout in the Territory, either (i) to those CMOs selected by Partner to Manufacture the Licensed Product for use by Partner in the Territory (which CMOs Partner will engage), or (ii) if agreed by the JSC for the Licensed Product, to Partner, as described in Section 4.2 6.2.1(a) (Manufacturing Technology Transfer). (gLocal [***]) if the Manufacturing Technology Transfer for the Licensed Product will be to Partner (and not one or more CMOs), review, discuss, and determine whether to approve (i) the Manufacturing Technology Transfer Plan for the Licensed Product [***] and (ii) any change in the scope of Manufacturing [***] activities to be transferred to Partner if agreed by the JSC in connection with the Manufacturing Technology Transfer [***] for the any Licensed Product, each as described in Section 4.2 (Manufacturing Technology Transfer[***]); (hg) review, discuss, and determine whether to approve any updates to the Territory Development Plan for the Licensed ProductProducts, in each case, as described in Section 5.2.1 5.2 (Territory Clinical DevelopmentDevelopment Plan); (i) [***]; (jh) review, discuss, and determine whether to approve any material updates to, the Global Development Plan for the Licensed Product Products with respect to activities to be conducted by Partner in the Territory, including Partner’s participation in the conduct of any Global Clinical Trial, each as described in Section 5.3 (Global Development Plan); (ki) review review, discuss, and discuss determine if Partner will be the Territory Sponsor for Global Clinical Trials to be conducted under the Global Development Plan (as set forth therein), as described in Section 5.3 (Global Development Plan); provided that Partner will have the right, following such review and discussion, to make such determination; (l) review, discuss, and determine whether to add any countries in the Territory as Selected Territory GCT Countries for a given Global Clinical Trial to be conducted under the Global Development Plan, as described in Section 5.3 (Global Development Plan); (m) determine the total number of patients to be enrolled in the Territory for a given Global Clinical Trial, as contemplated in the applicable protocol for such Global Clinical Trial, as described in Section 5.3 (Global Development Plan); (nj) review, discuss, and determine whether to approve any New Development Proposal, and review, discuss, and determine whether to approve any New Territory-Specific Development Activities, in each case, as described in Section 5.4 (New Development by Partner);; ​ ​ (o) discuss the status, progress, and results of the Parties’ respective Development activities, as described in Section 5.10 (Development Reports); (pk) review, discuss, and determine whether to approve the regulatory strategy for receipt of Regulatory Approval in each country or region in the Territory, as described in Section 6.1 (Regulatory Strategy); ​ ​ ; (ql) review and discuss Partner’s plan for undertaking additional regulatory activities for the any Licensed Product delegated by Kiniksa ImmunoGen or the JSC to Partner, as described in Section 6.2.1 (Obtaining and Maintaining Regulatory Approvals); (rm) review and discuss the transfer of the Manufacturing of the Licensed Product (or any component thereof) in the Territory to one or more CMOs in the Territory selected by Partner, as described in Section 6.2.1 (a) (Local Manufacturing); (s) review, discuss, and determine whether to permit Partner to Manufacture the Licensed Product in the Territory itself, instead of through one or more CMOs selected by Partner, as described in Section 6.2.1 (a) (Local Manufacturing); (t) review, discuss, and determine whether to approve Partner’s plan for undertaking any activities and interactions relating to obtaining and maintaining Local Manufacturing Approvals for the Licensed Product in the Territory, as described in Section 6.2.1 (a) (Local Manufacturing); (u) review, discuss, and determine whether to approve any substantive Regulatory Submissions that are in the name of KiniksaImmunoGen, as described in Section 6.2.3 6.2.1(b) (Review of Other Regulatory SubmissionsApprovals); (v) facilitate the Parties’ review and updating of Partner Process and Specifications and develop a plan for remediation of any deficiencies or limitations with respect to such Partner Process and Specifications, as described in Section 7.2.4 (Process and Specifications); (wn) review, discuss, and determine whether to approve Medical Affairs Plans for the Territory and any updates thereto for the Licensed ProductProducts, as described in Section 8.1 (Medical Affairs Plan); (xo) review, discuss, and determine whether to approve the Commercialization Plan for the Territory and any updates thereto for the Licensed ProductProducts, as described in Section 9.2 (Commercialization Plan); (yp) review, discuss, and determine whether to approve any brand strategy for the a Licensed Product that is specific to the Territory (or any country or region therein) and that is inconsistent with the Global Brand Strategy for the such Licensed Product, as described in Section 9.2 (Commercialization Plan); (zq) review, discuss, and determine whether to approve the use of any Product Xxxx for the a Licensed Product in the Territory that deviates from KiniksaImmunoGen’s Global Brand Elements, as described in Section 14.9.2 14.8.2 (Product Marks in the Territory); (r) review, discuss, and determine whether to approve [***] that are proposed by either Party [***]; and (aas) perform such other functions as expressly set forth in this Agreement or allocated to the JSC by the Parties’ written agreement.

JSC Roles and Responsibilities. The responsibilities of the JSC will be to: (a) provide a forum for the discussion of the Parties’ activities under this Agreement; (b) review and discuss matters that Kiniksa believes may have a Material Adverse Impact on the Development, Manufacturing, and CMC activities, performance of Medical Affairs, and Commercialization of Licensed ProductProducts in the Field in the Territory; (c) review ensure the Assigned Regulatory Materials and discuss Partnereach Party’s engagement of Subcontractors that are not Preapproved Subcontractorsroles and responsibilities therefor, as described in Section 2.2.3 3.5.1 (Right to SubcontractRegulatory Transfer), are reflected in operation between uniQure and Partner; (d) establish receive the Partner Development Plan and oversee any updates thereto, as described ​ ​ in Section 4.2 (Partner Development Plan); (e) receive the JDC Development reports, sublicense compliance reports and JMC and settle any disputes that arise within the JDC or JMCinvention disclosure reports provided by each Party, as described in Section 3.6.2 2.2.5 (Resolution Reports of JDC Sublicensees and JMC DisputesSubcontractors), Section 4.3 (Development Reporting) and Section 12.1.2 (Disclosure); (ef) review, discuss, and determine whether to approve the plan for the performance of any uniQure Additional Development Activities and, if so approved, the uniQure Additional Development Plan and uniQure Additional Development Budget, as described in Section 4.1.3 (uniQure Additional Development Activities); (g) review, discuss, and determine whether to approve any update to the Current Phase III Budget, as described in Section 4.4.1 (Current Phase III Protocol); (h) review, discuss, and determine whether to approve any update to the uniQure Additional Development Plan or uniQure Additional Development Budget, in each case, as described in Section 4.4.3 (uniQure Additional Development Plan and Budget); (i) oversee the implementation of, and the coordination between the Parties of activities to be performed under, the Clinical Supply Agreement, the Commercial Supply Agreement, the Safety SDE Agreements, and any other written agreement between the Parties with respect to the subject matter hereof; (f) determine Licensed Products in the appropriate time to perform the Manufacturing Technology Transfer for the Licensed Product, which Field in all cases will be conducted with sufficient time ​ ​ so that Partner can be the Marketing Authorization Holder for the Licensed Product throughout the Territory, either (i) to those CMOs selected by Partner to Manufacture the Licensed Product for use by Partner in the Territory (which CMOs Partner will engage), or (ii) if agreed by the JSC for the Licensed Product, to Partner, as described in Section 4.2 (Manufacturing Technology Transfer). (g) if the Manufacturing Technology Transfer for the Licensed Product will be to Partner (and not one or more CMOs), review, discuss, and determine whether to approve (i) the Manufacturing Technology Transfer Plan for the Licensed Product and (ii) any change in the scope of Manufacturing activities to be transferred to Partner if agreed by the JSC in connection with the Manufacturing Technology Transfer for the Licensed Product, each as described in Section 4.2 (Manufacturing Technology Transfer); (h) review, discuss, and determine whether to approve any updates to the Territory Development Plan for the Licensed Product, in each case, as described in Section 5.2.1 (Territory Clinical Development); (i) [***]; (j) review, discuss, and determine whether to approve any all material updates toto the Manufacturing Development Plan, the Global Development Plan for the Licensed Product with respect to activities to be conducted by Partner in the Territory, including Partner’s participation in the conduct of any Global Clinical Trial, each as described in Section 5.3 5.2 (Global Manufacturing Development Plan); (k) review and discuss if Partner will be the Territory Sponsor for Global Clinical Trials to be conducted under the Global Development Plan (as set forth therein), as described in Section 5.3 (Global Development Plan); provided that Partner will have the right, following such review and discussion, to make such determination; (l) review, discuss, and determine whether to add any countries in approve all updates to the Territory as Selected Territory GCT Countries for a given Global Clinical Trial to be conducted under the Global Development Manufacturing Responsibility Transfer Plan, as described in Section 5.3 5.3.3 (Global Development Manufacturing Responsibility Transfer Plan); (l) review and discuss the Partner Commercialization Plan and any updates thereto, as described in Section 6.4 (Partner Commercialization Plans); (m) determine review and discuss the total number of patients to be enrolled in the Territory for a given Global Clinical Trial, as contemplated in the applicable protocol for such Global Clinical TrialCommercialization reports provided by Partner, as described in Section 5.3 6.5 (Global Development PlanPartner Commercialization Reporting); (n) review, discuss, and determine whether resolve any disputed change to approve any New Development Proposal, the Product Specifications requested in accordance with Section 4.1.1 of the Supply Agreement and review, discuss, and determine whether that has been referred to approve any New Territory-Specific Development Activities, the JSC in each case, as described in accordance with Section 5.4 (New Development by Partner)4.1.3 of the Supply Agreement; (o) discuss the status, progress, and results of the Parties’ respective Development activities, as described in Section 5.10 (Development Reports); (p) review, discuss, and determine whether resolve any disputed change to approve the regulatory strategy for receipt of Regulatory Approval Manufacturing Process requested in each country or region in the Territory, as described in accordance with Section 6.1 (Regulatory Strategy); ​ ​ (q) review and discuss Partner’s plan for undertaking additional regulatory activities for the Licensed Product delegated by Kiniksa or the JSC to Partner, as described in Section 6.2.1 (Obtaining and Maintaining Regulatory Approvals); (r) review and discuss the transfer 4.1.2 of the Manufacturing of the Licensed Product (or any component thereof) in the Territory to one or more CMOs in the Territory selected by Partner, as described in Section 6.2.1 (a) (Local Manufacturing); (s) review, discuss, and determine whether to permit Partner to Manufacture the Licensed Product in the Territory itself, instead of through one or more CMOs selected by Partner, as described in Section 6.2.1 (a) (Local Manufacturing); (t) review, discuss, and determine whether to approve Partner’s plan for undertaking any activities and interactions relating to obtaining and maintaining Local Manufacturing Approvals for the Licensed Product in the Territory, as described in Section 6.2.1 (a) (Local Manufacturing); (u) review, discuss, and determine whether to approve any Regulatory Submissions that are in the name of Kiniksa, as described in Section 6.2.3 (Review of Regulatory Submissions); (v) facilitate the Parties’ review and updating of Partner Process and Specifications and develop a plan for remediation of any deficiencies or limitations with respect to such Partner Process and Specifications, as described in Section 7.2.4 (Process and Specifications); (w) review, discuss, and determine whether to approve Medical Affairs Plans for the Territory and any updates thereto for the Licensed Product, as described in Section 8.1 (Medical Affairs Plan); (x) review, discuss, and determine whether to approve the Commercialization Plan for the Territory and any updates thereto for the Licensed Product, as described in Section 9.2 (Commercialization Plan); (y) review, discuss, and determine whether to approve any brand strategy for the Licensed Product that is specific to the Territory (or any country or region therein) Supply Agreement and that is inconsistent with the Global Brand Strategy for the Licensed Product, as described in Section 9.2 (Commercialization Plan); (z) review, discuss, and determine whether to approve the use of any Product Xxxx for the Licensed Product in the Territory that deviates from Kiniksa’s Global Brand Elements, as described in Section 14.9.2 (Product Marks in the Territory); and (aa) perform such other functions as expressly set forth in this Agreement or allocated has been referred to the JSC by the Parties’ written agreement.in accordance with Section ​ ​

JSC Roles and Responsibilities. The responsibilities of the JSC will be to: (a) provide a forum for the discussion of the Parties’ activities under this Agreement; (b) review review, discuss, and discuss matters that Kiniksa believes may have a Material Adverse Impact on determine whether to approve the Licensed Product; (c) review initial list of Preapproved Subcontractors and discuss Partner’s engagement of Subcontractors that are not Preapproved Subcontractorsany updates thereto, as described in Section 2.2.3 (Right to Subcontract); (dc) oversee the JPTs and establish and oversee Working Groups as necessary or advisable to further the JDC and JMC purpose of this Agreement and settle any disputes that arise within the JDC any JPT or JMCWorking Groups, as described in Section 3.6.2 (Resolution of JDC JPT and JMC Working Group Disputes); (ed) oversee the implementation of, and the coordination between the Parties of activities to be performed under, the Clinical Supply Agreement, the Commercial Supply Agreement, the Safety Agreements, and any other written agreement between the Parties with respect to the subject matter hereof; (fe) review, discuss, and determine the appropriate time whether to perform the approve each Manufacturing Technology Transfer for the Licensed Product, which in all cases will be conducted with sufficient time ​ ​ so that Partner can be the Marketing Authorization Holder for the Licensed Product throughout the Territory, either (i) to those CMOs selected by Partner to Manufacture the Licensed Product for use by Partner in the Territory (which CMOs Partner will engage), or (ii) if agreed by the JSC for the Licensed Product, to PartnerPlan, as described in Section 4.2 (Manufacturing Technology Transfer).; (gf) if the Manufacturing Technology Transfer for the Licensed Product will be to Partner (and not one or more CMOs), review, discuss, and determine whether to approve (i) the Manufacturing Technology Transfer Plan for the Licensed Product and (ii) any change in the scope of Manufacturing activities to be transferred to Partner if agreed by the JSC Zai in connection with the Manufacturing Technology Transfer for the Licensed Productany Blueprint Compound and any updates or amendments thereto, each as described in Section 4.2 (Manufacturing Technology Transfer); (g) review, discuss, and determine whether to approve the [****] PRC Submission Estimated Timeline for each Licensed Product and each update thereto for each Licensed Product, in each case, as described in Section 5.6.2 (Amendments and Obligations); (h) review, discuss, and determine whether to approve any updates to the Territory initial Territory-Specific Development Plan for each Licensed Product and each update thereto, in each case, as described in Section 5.4 (Territory-Specific Development Plans); (i) review and discuss the initial Global Development Plan for each Licensed Product and each update thereto for any Licensed Product, in each case, as described in Section 5.2.1 5.1 (Territory Clinical DevelopmentGlobal Development Plan); (i) [***]; (j) review, discuss, and determine whether to approve allocation to Zai of any material updates to, new or additional activities under the Global Development Plan for the Licensed Product with respect to activities to be conducted by Partner in the TerritoryPlan, including Partner’s participation in the conduct of any Global Clinical Trialadditional Committed Trials proposed by Blueprint, each as described in Section 5.3 5.1 (Global Development Plan); (k) review and discuss if Partner will be the Territory Sponsor for Global Clinical Trials to be conducted under the Global Development Plan (as set forth therein), as described in Section 5.3 (Global Development Plan); provided that Partner will have the right, following such review and discussion, to make such determination; (l) review, discuss, and determine whether to add any countries in the Territory as Selected Territory GCT Countries approve for a given Global Clinical Trial to be conducted Development under the Global Development Plan, as described in Section 5.3 (Global Development Plan)this Agreement [****]; (m) determine the total number of patients to be enrolled in the Territory for a given Global Clinical Trial, as contemplated in the applicable protocol for such Global Clinical Trial, as described in Section 5.3 (Global Development Plan); (nl) review, discuss, and determine whether to approve any New Development Proposal, and review, discuss, and determine whether to approve any New Territory-Specific Development Activities, in each case, as described in Section 5.4 5.9 (New Development Proposed by PartnerXxx); (o) discuss the status, progress, and results of the Parties’ respective Development activities, as described in Section 5.10 (Development Reports); (pm) review, discuss, and determine whether to approve the regulatory strategy for receipt of Regulatory Approval in the Territory with respect to each country or region in the TerritoryLicensed Product and each update thereto, as described in Section 6.1 (Regulatory Strategy); ​ ​ ; (qn) review and discuss PartnerXxx’s plan for undertaking additional regulatory activities for the any Licensed Product delegated by Kiniksa Blueprint or the JSC to PartnerZai, as described in Section 6.2.1 (Obtaining and Maintaining Regulatory Approvals); (ro) review review, discuss, and discuss determine matters that may have a material adverse impact upon the transfer of the Manufacturing regulatory status of the Licensed Product Products pursuant to Section 6.7 (or any component thereof) in the Territory to one or more CMOs in the Territory selected by Partner, as described in Section 6.2.1 (a) (Local ManufacturingNo Harmful Actions); (sp) discuss and determine whether to approve [****]; (q) review, discuss, and determine whether to permit Partner to Manufacture the Licensed Product in the Territory itself, instead of through one or more CMOs selected by Partnerapprove each Medical Affairs Plan and each update thereto, as described in Section 6.2.18.1 (Medical Affairs Plans); (ar) review, discuss, and determine whether to approve each Commercialization Plan and each update thereto, as described in Section 9.2 (Local ManufacturingCommercialization Plans); (s) determine whether a Product Xxxx is not appropriate for the Territory due to linguistic reasons or market research showing that such Product Mark is not appropriate, and review and comment on any alternative Product Marks selected by Xxx, in each case, as described in Section 14.9.2 (Product Marks in the Territory); (t) review, discuss, and determine whether to approve Partner’s plan any brand strategy for undertaking any activities and interactions relating to obtaining and maintaining Local Manufacturing Approvals for the a Licensed Product in that is specific to the TerritoryTerritory (or any region therein) and that is inconsistent with the Global Brand Strategy for such Licensed Product, as described in Section 6.2.1 9.2 (a) (Local ManufacturingCommercialization Plans); (u) review, discuss, and determine whether to approve any Regulatory Submissions that are in the name of Kiniksa, as described in Section 6.2.3 (Review of Regulatory Submissions); (v) facilitate the Parties’ review and updating of Partner Process and Specifications and develop a plan for remediation of any deficiencies or limitations with respect to such Partner Process and Specifications, as described in Section 7.2.4 (Process and Specifications); (w) review, discuss, and determine whether to approve Medical Affairs Plans for the Territory and any updates thereto for the alternative Licensed Product, as described -specific trademark selected by Zai in Section 8.1 (Medical Affairs Plan); (x) review, discuss, and determine whether to approve the Commercialization Plan for the Territory and any updates thereto for the Licensed Product, as described in Section 9.2 (Commercialization Plan); (y) review, discuss, and determine whether to approve any brand strategy for the Licensed Product that is specific to the Territory (or any country or region therein) and that is inconsistent accordance with the Global Brand Strategy for the Licensed Product, as described in Section 9.2 (Commercialization Plan); (z) review, discuss, and determine whether to approve the use of any Product Xxxx for the Licensed Product in the Territory that deviates from Kiniksa’s Global Brand Elements, as described in Section 14.9.2 (Product Marks in the Territory); and (aav) perform such other functions as expressly set forth in this Agreement or allocated to the JSC by the Parties’ written agreement.