Common use of Specific Responsibilities Clause in Contracts

Specific Responsibilities. In particular, the DWG shall: (a) oversee and coordinate the on-going sharing and transfer of Know-How generated in or related to the Development of Licensed Products; (b) oversee the implementation of the GDP for each Licensed Product for the Development of such Licensed Product; (c) review and update the Core Development Plan for each Co-Promote Product and Core Development Budget for such Co-Promote Product set forth therein [***] a year and, from time to time, present to the JSC for review and approval proposed substantive amendments to the Core Development Plan, including the Core Development Budget, in accordance with Section 4.2.5; (d) on a Licensed Product-by-Licensed Product basis, develop and propose to the JSC for review and approval a regulatory and clinical strategy for such Licensed Product (“Regulatory Strategy”); (e) oversee the implementation of the Regulatory Strategy for the Regulatory Approval of each Co-Promote Product once it has been approved by the JSC; (f) in connection with each Co-Promote Option for a Licensed Product, discuss any Phase 1 Clinical Study Report and any proposed Core Development Plan and Core Development Budget for such Licensed Product, along with any amendment to such proposed Core Development Plan and Core Development Budget; (g) provide a forum for the Parties to review and discuss regulatory matters as provided in Section 4.4; (h) review each clinical study design and protocol, including clinical study endpoints, clinical methodology and monitoring requirements for each Clinical Study with respect to a Licensed Product, and approve the same with respect the Existing Product or any Co-Promote Product; (i) review each IND, Drug Approval Application, other major Regulatory Filing, and post-filing requirements with respect to a Licensed Product, and approve the same with respect the Existing Product or any Co-Promote Product; (j) review the design and protocol of and oversee performance of GLP toxicology studies or other studies to support IND filing of Licensed Products in the Field, and approve the same with respect the Existing Product or any Co-Promote Product; (k) discuss and implement processes and procedures, including under the Pharmacovigilance Agreement, for sharing information needed to support each Party’s (or their Affiliates’) respective regulatory responsibilities and which may be necessary for compliance with the applicable regulatory pharmacovigilance requirements; (l) review and submit to the JSC for approval any New Product Proposal; and (m) perform such other functions as are assigned to it in this Agreement or as are appropriate to further the purposes of this Agreement as agreed in writing by the Parties.

Specific Responsibilities. In particular, The JMC shall have the DWG shallfollowing specific responsibilities: (a) oversee review and coordinate the on-going sharing and transfer of Know-How generated in or related to approve the Development of Licensed ProductsPlan (and the Development Budget set forth therein), the Commercialization Plans (and the Commercialization Budgets set forth therein), and any updates or modifications thereto, on an annual basis; (b) oversee the implementation keep each Party reasonably informed of the GDP for each Licensed Product for other Party’s Development activities, Commercialization activities and interactions with Regulatory Authorities, by receiving no less than quarterly updates from the Development of Party conducting such Licensed Productactivities; (c) review and update reconcile the Core actual Development Plan for Costs incurred by each Co-Promote Product and Core Development Budget for such Co-Promote Product set forth therein [***] a year and, from time to time, present to the JSC for review and approval proposed substantive amendments to the Core Development Plan, including the Core Development Budget, Party in accordance with Section 4.2.54.2 (Development Costs); (d) on a Licensed Product-by-Licensed Product basis, develop and propose to the JSC for review and approval a regulatory and clinical strategy for such Licensed Product (“Regulatory Strategy”)[***]; (e) oversee and approve the implementation process by which Partner may undertake any second source manufacture and supply responsibilities and the allocation of the Regulatory Strategy for the Regulatory Approval supply of each Co-Promote Licensed Product once it has been approved by the JSCfrom such second source, pursuant to Section 6.4 (Partner’s Ability to Become a Second Manufacturing Source); (f) discuss and agree upon the nature and scope of Commercialization activities that require a unified approach or coordination across the European Union, in connection accordance with each Co-Promote Option for a Licensed ProductSection 7.1 (Generally); Portions of this Exhibit, discuss any Phase 1 Clinical Study Report indicated by the ▇▇▇▇ “[***],” were omitted and any proposed Core Development Plan have been filed separately with the Securities and Core Development Budget for such Licensed ProductExchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, along with any amendment to such proposed Core Development Plan and Core Development Budget;as amended. (g) provide a forum for determine and approve (i) the Parties Product Marks to review be used to Commercialize Licensed Product in the Territory and discuss regulatory matters as provided (ii) the guidelines and cost allocation with respect such use, in each case pursuant to Section 4.47.4 (Trademarks; Packaging; Promotional Materials); (h) prepare and review each clinical study design and protocolupdates to the Collaboration P&L, including clinical study endpoints, clinical methodology and monitoring requirements for each Clinical Study in accordance with respect to a Licensed Product, and approve the same with respect the Existing Product or any Co-Promote ProductSection 8.2 (Collaboration P&L); (i) review each IND, Drug Approval Application, other major Regulatory Filing, and post-filing requirements resolve any disputes regarding the ownership of Inventions in accordance with respect to a Licensed Product, and approve the same with respect the Existing Product or any Co-Promote ProductSection 10.1 (Ownership of Inventions); (j) review the design and protocol approve any Third Party license agreements entered into by either Party in accordance with Section 10.2 (JMC Approval of and oversee performance of GLP toxicology studies or other studies to support IND filing of Licensed Products in the Field, and approve the same with respect the Existing Product or any Co-Promote ProductThird Party Licenses; [***]); (k) on a periodic basis as appropriate, discuss (i) any additional Biosimilar products that either Party seeks to include as a Licensed Product hereunder as contemplated by Section 2.5 (Additional Licensed Compounds), and implement processes and procedures(ii) for any then-existing Licensed Products, including under expanding the Pharmacovigilance Agreement, for sharing information needed Territory to support each Party’s (or their Affiliates’) respective regulatory responsibilities and which may be necessary for compliance with the applicable regulatory pharmacovigilance requirements;include any additional countries; and (l) review and submit to the JSC for approval perform any New Product Proposal; and (m) perform such other activities or functions as are assigned to it the Parties may mutually agree in this Agreement or as are appropriate to further the purposes of this Agreement as agreed in writing by the Partieswriting.

Specific Responsibilities. In particular, the DWG shall: (a) oversee addition to its overall responsibility for monitoring and providing a forum to discuss and coordinate the on-going sharing and transfer of Know-How generated in or related to the Development of Licensed Products; (b) oversee the implementation of the GDP for each Licensed Product for the Development of such Licensed Product; (c) review and update the Core Development Plan for each Co-Promote Product and Core Development Budget for such Co-Promote Product set forth therein [***] a year andParties’ activities under this Agreement, from time to time, present to the JSC for review and approval proposed substantive amendments to the Core Development Plan, including the Core Development Budget, shall in accordance with Section 4.2.5; (d) on a Licensed Product-by-Licensed Product basis, develop and propose to the JSC for review and approval a regulatory and clinical strategy for such Licensed Product (“Regulatory Strategy”); (e) oversee the implementation of the Regulatory Strategy for the Regulatory Approval of each Co-Promote Product once it has been approved by the JSC; (f) in connection with each Co-Promote Option for a Licensed Product, discuss any Phase 1 Clinical Study Report and any proposed Core Development Plan and Core Development Budget for such Licensed Product, along with any amendment to such proposed Core Development Plan and Core Development Budget; (g) provide a forum for the Parties to review and discuss regulatory matters as provided in Section 4.4; (h) review each clinical study design and protocol, including clinical study endpoints, clinical methodology and monitoring requirements for each Clinical Study with respect to a Licensed Product, and approve the same with respect the Existing Product or any Co-Promote Product;particular: (i) oversee the collaborative activities of the Parties under this Agreement, create and review each INDthe overall strategy for Developing and seeking Regulatory Approval for, Drug Approval Application, other major Regulatory FilingManufacturing, and post-filing requirements Commercializing Collaboration Products, in the Field in the Territory; (ii) receive and discuss reports from the JDC, the JCC, the JFC, and the JPC, and provide guidance thereto, approve the Development Plan(s) (including the Development Budget(s)) and the Commercialization Plan(s) (including the Commercialization Budget(s)), and any amendments thereto; (iii) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; (iv) attempt to resolve issues presented to it by, and disputes within, the JDC, the JCC, the JFC, and the JPC, or any other committee; (v) review and approve decisions to terminate Development on any Collaboration Product, including with respect to a Licensed Productspecific indications; (vi) discuss and decide whether to Develop Collaboration Products (other than TRU-016) and for which indications; (vii) select the Lead Development Party, Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and review and approve any changes thereto; (viii) review and approve the same manufacturing plan [*] with respect the Existing Product or any Co-Promote Productassociated budget, resource allocation and regulatory plans; (jix) review the design and protocol approve (A) inclusion of and oversee performance of GLP toxicology studies or other studies to support IND filing of Licensed Products any costs not specifically enumerated in the Fielddefinitions of Development Costs or Commercialization Costs or any component thereof, and approve (B) any costs incurred by a Party that exceed that the same portion of the applicable Development Budgets or Commercialization Budgets allocated to such Party with respect to the Existing Product or any Co-Promote Productrelevant Calendar Quarter by more than [*]; (kx) review and approve any changes to the specific responsibilities of the JDC, the JCC, the JFC, and the JPC; (xi) discuss and implement processes and procedures, including under the Pharmacovigilance Agreement, for sharing information needed to support each Party’s (or their Affiliates’) respective regulatory responsibilities and which may be necessary for compliance make determinations regarding material safety issues with the applicable regulatory pharmacovigilance requirements; (l) review and submit respect to the JSC for approval any New Product ProposalCollaboration Product; and (mxii) perform such other functions as are assigned to it in this Agreement or as are appropriate to further the purposes of this Agreement as agreed allocated to it in writing by the Parties.

Specific Responsibilities. In particularThe JSC shall have the following responsibilities with respect to the Project generally, the DWG shallProject Plan, and to the Assay and the IVD Kit: (ai) oversee Oversee the progress of the Activities under the Project and coordinate facilitate the on-going sharing exchange of information between the Parties during the Term; ​ 1. ​ ​ (ii) Review quarterly progress reports under the Project and transfer of Know-How generated in or related Project Plan, as well as quarterly updates on regulatory activities (including the Regulatory Approval process and timelines), communications and coordination. Each Party shall deliver such reports to the Development of Licensed ProductsJSC on a timely manner; (biii) oversee Review and approve any scope changes as described in Section 2.2 to the implementation of the GDP for each Licensed Product for the Development of such Licensed ProductProject Plan and timelines therefor; (civ) Maintain the list of Target Countries and make modifications thereto upon APR’s notification and upon the appropriate adjustments in the Budget and Pass Through Expenses pursuant to Section 3.6. For clarity, Target Countries shall be determined by APR and not the JSC, but subject to agreement on the amended Budget as provided in Section 3.6; (v) Align strategy and timing for the Regulatory Approval of the Assay and IVD Kit (including the labeling thereof) with the regulatory strategy and timing for the APR Product (including the labeling thereof); provided that the regulatory strategy for the APR Product (including the labeling thereof) shall be solely determined by APR, as set forth in Section 4.1; (vi) Annually review and update modify the Core Project Plan (including timelines) and Budget (including appropriate adjustments to reflect costs for Regulatory Approval of the Assay and/or the IVD Kit arising from newly identified and/or changes to Target Countries); (vii) Establish, monitor and delegate duties to other committees, subcommittees, or directed teams (each a “Working Group”) on an “as needed” basis to oversee particular projects or activities, including the Joint Development Plan for each CoCommittee (the “JDC”), which is described below; (viii) Hear and resolve disputes of the Working Groups, including the JDC; (ix) Approve all Pass-Promote Product and Core Development Budget for such Co-Promote Product set forth therein Through Expenses in excess of $[***] a year in total; and, (x) Taking such other actions as may be specifically allocated to the JSC by the Parties from time to time; Each Party shall retain the rights, present powers and discretion granted to it under this Agreement and no such rights, powers or discretion shall be delegated to or vested in the JSC unless such delegation or vesting of rights is expressly provided for review and approval proposed substantive amendments to the Core Development Plan, including the Core Development Budget, in accordance with Section 4.2.5; (d) on a Licensed Product-by-Licensed Product basis, develop and propose to the JSC for review and approval a regulatory and clinical strategy for such Licensed Product (“Regulatory Strategy”); (e) oversee the implementation of the Regulatory Strategy for the Regulatory Approval of each Co-Promote Product once it has been approved by the JSC; (f) in connection with each Co-Promote Option for a Licensed Product, discuss any Phase 1 Clinical Study Report and any proposed Core Development Plan and Core Development Budget for such Licensed Product, along with any amendment to such proposed Core Development Plan and Core Development Budget; (g) provide a forum for the Parties to review and discuss regulatory matters as provided in Section 4.4; (h) review each clinical study design and protocol, including clinical study endpoints, clinical methodology and monitoring requirements for each Clinical Study with respect to a Licensed Product, and approve the same with respect the Existing Product or any Co-Promote Product; (i) review each IND, Drug Approval Application, other major Regulatory Filing, and post-filing requirements with respect to a Licensed Product, and approve the same with respect the Existing Product or any Co-Promote Product; (j) review the design and protocol of and oversee performance of GLP toxicology studies or other studies to support IND filing of Licensed Products in the Field, and approve the same with respect the Existing Product or any Co-Promote Product; (k) discuss and implement processes and procedures, including under the Pharmacovigilance Agreement, for sharing information needed to support each Party’s (or their Affiliates’) respective regulatory responsibilities and which may be necessary for compliance with the applicable regulatory pharmacovigilance requirements; (l) review and submit to the JSC for approval any New Product Proposal; and (m) perform such other functions as are assigned to it in this Agreement or as are appropriate to further the purposes Parties expressly so agree in writing. For the avoidance of this Agreement as agreed in writing by doubt, APR shall be solely responsible for the Partiesperformance of all clinical trials of the APR Product.

Specific Responsibilities. In particular, the DWG JCC shall: (a) oversee and coordinate the on-going sharing and transfer transfer, in accordance with the terms of this Agreement, from Infinity to AbbVie of Infinity Know-How generated in or How, and from AbbVie to Infinity of AbbVie Know-How, related to the Development Commercialization of Licensed ProductsCompounds and Products so that each Party may undertake Commercialization of Licensed Compounds and Products in accordance with the Commercialization Plans and this Agreement; (b) oversee the implementation of Manufacturing Working Group to ensure that Manufacturing Plans, and related budget information, are incorporated into the GDP for each Licensed Product for the Development of such Licensed Productapplicable Commercialization Plans; (c) develop and update, on an annual basis, Manufacturing Plans for inclusion in the Commercialization Plans to ensure a reliable commercial supply of the Licensed Compound and Products in the Territory; (d) coordinate with the JDC with respect to regulatory matters; (e) coordinate with the JDC with respect to pharmacovigilance matters; (f) develop and present to the JSC for approval the Global Branding Strategy and updates to such Global Branding Strategy during the Term as necessary; (g) review and update present to the Core Development JSC for approval the initial US Commercialization Plan, including the US Commercialization Budget therein and the allocation of Commercialization activities between the Parties, which US Commercialization Plan for each Co-Promote Product shall be consistent with the Global Branding Strategy and Core Development Budget for such Co-Promote Product set forth therein [***] a year Section 5.3.1, in accordance with this Agreement and, from time to timeas appropriate, present to the JSC for review and approval proposed substantive updates and amendments to the Core Development such US Commercialization Plan, including the Core Development Budget, in accordance with Section 4.2.5US Commercialization Budget included therein; (dh) review and comment on a Licensed Productthe initial or updated (as applicable) Ex-byUS Commercialization Plan, and any material amendments to such Ex-Licensed Product basisUS Commercialization Plans, develop and propose submit such plans to the JSC for review and approval a regulatory and clinical strategy for such Licensed Product (“Regulatory Strategy”)approval; (ei) coordinate the activities of the Parties under the US Commercialization Plan and oversee the implementation of the Regulatory Strategy for the Regulatory Approval of each Co-Promote Product once it has been approved by the JSC; (f) in connection with each Co-Promote Option for a Licensed Product, discuss any Phase 1 Clinical Study Report and any proposed Core Development US Commercialization Plan and Core Development Budget for such Licensed Product, along with any amendment to such proposed Core Development Plan and Core Development Budget; (g) provide a forum for oversee the Parties to review and discuss regulatory matters as provided in Section 4.4; (h) review each clinical study design and protocol, including clinical study endpoints, clinical methodology and monitoring requirements for each Clinical Study with respect to a Licensed Product, and approve implementation of the same with respect the Existing Product or any CoEx-Promote Product; (i) review each IND, Drug Approval Application, other major Regulatory Filing, and post-filing requirements with respect to a Licensed Product, and approve the same with respect the Existing Product or any Co-Promote ProductUS Commercialization Plan; (j) review the design and protocol of and oversee performance of GLP toxicology studies or other studies to support IND filing of Licensed Products each Party’s Commercialization activities in the FieldUS and AbbVie’s Commercialization activities in the Ex-US Territory, and approve the same with respect the Existing Product including a review of actual financial results versus budget or any Co-Promote Productplan; (k) discuss to the extent necessary, share planning and implement processes and procedures, including under the Pharmacovigilance Agreement, for sharing budgeting information needed to support each Party’s (or their Affiliates’) respective regulatory responsibilities and which may be necessary for compliance with the applicable regulatory pharmacovigilance requirementsJDC and JMAC and coordinate with the JDC and JMAC in preparing comprehensive planning and budgeting proposals with respect to the Development, Manufacture and Commercialization of Products and Medical Affairs Activities in the Field in the US, as applicable; (l) review and submit comment upon amendments and updates to the JSC Global Publication Strategy developed and presented by the JMAC in accordance with Section 9.4.1; (m) oversee the Manufacturing Working Group, Co-Promotion Working Group and any other Working Group that reports to the JCC; (n) review and approve terms for approval any New Co-Promotion of Product Proposalin the United States for inclusion in the US Commercialization Plan; (o) review and update, on an annual basis, pricing, discounting and reimbursement decisions for inclusion in the US Commercialization Plan; and (mp) perform such other functions as are assigned to it in this Agreement or as are appropriate to further the purposes of this Agreement as to the extent agreed in writing by the Parties.

Specific Responsibilities. In particular, the DWG JMAC shall: (a) oversee and coordinate the on-going sharing and transfer transfer, in accordance with the terms of this Agreement, from Infinity to AbbVie of Infinity Know-How generated in or How, and from AbbVie to Infinity of AbbVie Know-How, related to the Development Medical Affairs Activities with respect to the Licensed Compounds and Products so that each Party may undertake Medical Affairs Activities of Licensed ProductsCompounds and Products in accordance with the Medical Affairs Plan and this Agreement; (b) oversee prepare and present to the implementation JSC for approval the initial Medical Affairs Plan (with input from the JDC and JCC), including the Medical Affairs Budget therein, and the allocation of responsibilities between the GDP for each Licensed Product for the Development of such Licensed Product; (c) review and update the Core Development Plan for each Co-Promote Product and Core Development Budget for such Co-Promote Product set forth therein [***] a year Parties and, from time to timeas appropriate, prepare and present to the JSC for review and approval proposed substantive interim and annual updates and amendments to the Core Development such Medical Affairs Plan, including the Core Development Medical Affairs Budget; (c) review, in accordance with Section 4.2.5approve and manage all Investigator Sponsored Clinical Studies and ensure adherence to the Parties’ corporate policies and all federal/state regulations; (d) on a Licensed Product-by-Licensed Product basis, develop coordinate the activities of the Parties under the Medical Affairs Plan and propose to oversee the JSC for review and approval a regulatory and clinical strategy for such Licensed Product (“Regulatory Strategy”)implementation of the Medical Affairs Plan; (e) oversee prepare and approve the implementation of Global Publication Strategy (with input from the Regulatory Strategy for the Regulatory Approval of each Co-Promote Product once it has been approved by the JSCJDC and JCC) and any amendments thereto; (f) prepare a MSL Deployment Plan for each of the United States, each Major Market Country and certain other territories or regions in connection the Territory in accordance with each Co-Promote Option for a Licensed Product, discuss any Phase 1 Clinical Study Report and any proposed Core Development Plan and Core Development Budget for such Licensed Product, along with any amendment to such proposed Core Development Plan and Core Development Budgetthe Medical Affairs Plan; (g) provide a forum for the Parties to review coordinate Congresses, scientific symposia, and discuss regulatory matters as provided in Section 4.4scientific advisory boards; (h) review each clinical study design develop scientific and protocol, including clinical study endpoints, clinical methodology and monitoring requirements for each Clinical Study with respect to a Licensed Product, and approve the same with respect the Existing Product or any Co-Promote Productmedical education communication platforms; (i) review each IND, Drug Approval Application, other major Regulatory Filing, provide a forum for and post-filing requirements facilitate communications between the Parties with respect to a the Medical Affairs Activities for the Licensed Product, Compound and approve the same with respect the Existing Product or any Co-Promote ProductProducts; (j) review the design and protocol of and oversee performance of GLP toxicology studies or other studies meet promptly following its formation to support IND filing of Licensed Products in the Field, and approve the same discuss Infinity’s ongoing Medical Affairs Activities with respect to the Existing Product or any Co-Promote Productand the continuation of such activities until such time as the JMAC establishes the initial Medical Affairs Plan; (k) discuss oversee the IST/IIS Working Group and implement processes and procedures, including under any other Working Group that reports to the Pharmacovigilance Agreement, for sharing information needed to support each Party’s (or their Affiliates’) respective regulatory responsibilities and which may be necessary for compliance with the applicable regulatory pharmacovigilance requirementsJMAC; (l) review and submit to each Party’s Medical Affairs Activities under the JSC for approval any New Product ProposalMedical Affairs Plan including review of actual financial results versus budget or plan; and (m) perform such other functions as are assigned to it in this Agreement or as are may be appropriate to further the purposes of this Agreement as agreed in writing by with respect to the PartiesMedical Affairs activities for the Licensed Compound and Products.

Specific Responsibilities. In particular, the DWG shall: (a) oversee addition to its overall responsibility for monitoring and providing a forum to discuss and coordinate the on-going sharing and transfer of Know-How generated in or related to the Development of Licensed Products; (b) oversee the implementation of the GDP for each Licensed Product for the Development of such Licensed Product; (c) review and update the Core Development Plan for each Co-Promote Product and Core Development Budget for such Co-Promote Product set forth therein [***] a year andParties’ activities under this Agreement, from time to time, present to the JSC for review and approval proposed substantive amendments to the Core Development Plan, including the Core Development Budget, shall in accordance with Section 4.2.5; (d) on a Licensed Product-by-Licensed Product basis, develop and propose to the JSC for review and approval a regulatory and clinical strategy for such Licensed Product (“Regulatory Strategy”); (e) oversee the implementation of the Regulatory Strategy for the Regulatory Approval of each Co-Promote Product once it has been approved by the JSC; (f) in connection with each Co-Promote Option for a Licensed Product, discuss any Phase 1 Clinical Study Report and any proposed Core Development Plan and Core Development Budget for such Licensed Product, along with any amendment to such proposed Core Development Plan and Core Development Budget; (g) provide a forum for the Parties to review and discuss regulatory matters as provided in Section 4.4; (h) review each clinical study design and protocol, including clinical study endpoints, clinical methodology and monitoring requirements for each Clinical Study with respect to a Licensed Product, and approve the same with respect the Existing Product or any Co-Promote Product;particular: (i) oversee the collaborative activities of the Parties under this Agreement, create and review each INDthe overall strategy for Developing and seeking Regulatory Approval for, Drug Approval Application, other major Regulatory FilingManufacturing, and post-filing requirements Commercializing Collaboration Products, in the Field in the Territory; (ii) receive and discuss reports from the JDC, the JCC, the JFC, and the JPC, and provide guidance thereto, approve the Development Plan(s) (including the Development Budget(s)) and the Commercialization Plan(s) (including the Commercialization Budget(s)), and any amendments thereto; (iii) establish such additional joint subcommittees as it deems necessary to achieve the objectives and intent of this Agreement; (iv) attempt to resolve issues presented to it by, and disputes within, the JDC, the JCC, the JFC, and the JPC, or any other committee; [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (v) review and approve decisions to terminate Development on any Collaboration Product, including with respect to a Licensed Productspecific indications; (vi) discuss and decide whether to Develop Collaboration Products (other than TRU-016) and for which indications; (vii) select the Lead Development Party, Lead Regulatory Party, Lead Manufacture Party, and Lead Commercialization Party, and review and approve any changes thereto; (viii) review and approve the same manufacturing plan [ * ] with respect the Existing Product or any Co-Promote Productassociated budget, resource allocation and regulatory plans; (jix) review the design and protocol approve (A) inclusion of and oversee performance of GLP toxicology studies or other studies to support IND filing of Licensed Products any costs not specifically enumerated in the Fielddefinitions of Development Costs or Commercialization Costs or any component thereof, and approve (B) any costs incurred by a Party that exceed that the same portion of the applicable Development Budgets or Commercialization Budgets allocated to such Party with respect to the Existing Product or any Co-Promote Productrelevant Calendar Quarter by more than [ * ]; (kx) review and approve any changes to the specific responsibilities of the JDC, the JCC, the JFC, and the JPC; (xi) discuss and implement processes and procedures, including under the Pharmacovigilance Agreement, for sharing information needed to support each Party’s (or their Affiliates’) respective regulatory responsibilities and which may be necessary for compliance make determinations regarding material safety issues with the applicable regulatory pharmacovigilance requirements; (l) review and submit respect to the JSC for approval any New Product ProposalCollaboration Product; and (mxii) perform such other functions as are assigned to it in this Agreement or as are appropriate to further the purposes of this Agreement as agreed allocated to it in writing by the Parties.

Specific Responsibilities. In particular, the DWG JDC shall: (a) oversee and coordinate the on-going sharing and transfer transfer, in accordance with the terms of this Agreement, from Infinity to AbbVie of Infinity Know-How generated in or How, and from AbbVie to Infinity of AbbVie Know-How, related to the Development of Licensed ProductsCompounds and Products so that each Party may undertake Development of Licensed Compounds and Products in accordance with the GDP and this Agreement; (b) coordinate the activities of the Parties under the GDP and oversee the implementation of the GDP for each Licensed Product for the Development of such Licensed ProductGDP; (c) review to the extent necessary, share planning and budgeting information with the JCC and the JMAC and coordinate with the JCC and JMAC in preparing comprehensive planning and budgeting proposals with respect to the Development, Commercialization, Manufacturing and Medical Affairs Activities of Products in the Field, as applicable; (d) develop and update, on an annual basis, the proposed global regulatory strategy for the Products in the Field in the Territory, and include such proposed strategy in the GDP, for approval by the JSC in accordance with this Agreement; (e) on an annual basis, update the Core Development Plan for each Co-Promote Product and Core GDP, including the Development Budget for such Co-Promote Product set forth therein [***] a year and, from time to time, and the allocation of Development responsibilities between the Parties and present to the JSC for review and approval proposed substantive amendments to the Core Development PlanGDP, including the Core Development Budget, in accordance with Section 4.2.5; (d) on a Licensed Product-by-Licensed Product basis, develop and propose to the JSC for review and approval a regulatory and clinical strategy for such Licensed Product (“Regulatory Strategy”); (e) oversee the implementation of the Regulatory Strategy for the Regulatory Approval of each Co-Promote Product once it has been approved by the JSC4.1.5; (f) develop and update, on an annual basis, for inclusion in connection with each Cothe GDP, the CMC Development plans and the Manufacturing Plans for the pre-Promote Option for a clinical and clinical supply of the Licensed Product, discuss any Phase 1 Clinical Study Report Compound and any proposed Core Development Plan and Core Development Budget for such Licensed Product, along with any amendment to such proposed Core Development Plan and Core Development BudgetProducts in the Territory; (g) provide a forum for the Parties to review and discuss regulatory matters as provided comment on Regulatory Filings relating to the Products in the Field in accordance with Section 4.4; (h) review each clinical study design and protocol, including clinical study endpoints, clinical methodology comment on the initial Global Publication Strategy and monitoring requirements for each Clinical Study amendments thereto prepared and presented by the JMAC from time to time in accordance with respect to a Licensed Product, and approve the same with respect the Existing Product or any Co-Promote ProductSection 9.4.1; (i) review each INDoversee the Regulatory Working Group, Drug Approval Applicationthe Pharmacovigilance Working Group, the Manufacturing Working Group, the IP Working Group, the Translational Medicine Working Group and any other major Regulatory Filing, and post-filing requirements with respect Working Groups that reports to a Licensed Product, and approve the same with respect the Existing Product or any Co-Promote ProductJDC; (j) review the design monitor progress and protocol of and oversee performance of GLP toxicology studies or other studies to support IND filing of Licensed Products in the Field, and approve the same with respect the Existing Product or any Co-Promote Product; (k) discuss and implement processes and proceduresDevelopment activities under this Agreement, including under the Pharmacovigilance Agreement, for sharing information needed to support each Party’s (a review of actual financial results versus budget or their Affiliates’) respective regulatory responsibilities and which may be necessary for compliance with the applicable regulatory pharmacovigilance requirements; (l) review and submit to the JSC for approval any New Product Proposalplan; and (mk) perform such other functions as are assigned to it in this Agreement or as are appropriate to further the purposes of this Agreement as agreed in writing by the Parties.

Specific Responsibilities. The JDC shall, consistent with the rights and obligations of the Parties set forth in this Agreement, develop the strategies for and oversee the Development, but not the Manufacturing or Commercialization, of the Product in the Territory, and shall serve as a forum for the coordination of Development, but not Manufacturing or Commercialization, activities for the Product for the Territory. In particular, the DWG JDC shall: (a) oversee and coordinate the on-going sharing and transfer of Know-How generated in or related to the Development of Licensed Products; (b) oversee the implementation of the GDP for each Licensed Product for the Development of such Licensed Product; (c) review and update the Core Development Plan for each Co-Promote Product and Core Development Budget for such Co-Promote Product set forth therein [***] a year and, from time to time, present to the JSC for review and approval proposed substantive amendments to the Core Development Plan, including the Core Development Budget, in accordance with Section 4.2.5; (d) on a Licensed Product-by-Licensed Product basis, develop and propose to the JSC for review and approval a regulatory and clinical strategy for such Licensed Product (“Regulatory Strategy”); (e) oversee the implementation of the Regulatory Strategy for the Regulatory Approval of each Co-Promote Product once it has been approved by the JSC; (f) in connection with each Co-Promote Option for a Licensed Product, discuss any Phase 1 Clinical Study Report and any proposed Core Development Plan and Core Development Budget for such Licensed Product, along with any amendment to such proposed Core Development Plan and Core Development Budget; (g) provide a forum for the Parties to review and discuss regulatory matters as provided in Section 4.4; (h) review each clinical study design and protocol, including clinical study endpoints, clinical methodology and monitoring requirements for each Clinical Study with respect to a Licensed Product, and approve the same with respect the Existing Product or any Co-Promote Product; (i) review each IND, Drug Approval Application, other major and provide input regarding the Development of and Regulatory Filing, Approvals for the Product for the Initial Indication and post-filing requirements with respect to a Licensed Product, the [**] in the United States and approve the same with respect the Existing Product or any Co-Promote ProductEuropean Union; (jii) oversee all Clinical Studies and Post-Approval Studies for the Product for the Initial Indication and the [**] in the United States and the European Union; (iii) review, provide input and direction regarding, and oversee strategies for obtaining Regulatory Approvals, including Regulatory Approvals for Product Labeling for indications in addition to the Initial Indication, for the Product in the United States and the European Union; (iv) review, provide input and direction regarding, and oversee strategies for obtaining Regulatory Approvals, including Regulatory Approvals for Product Labeling, for the Product in the Territory outside of the United States and the European Union for any indication; (v) review the design and protocol of and oversee performance of GLP toxicology studies or other studies progress reports made by each Party pursuant to support IND filing of Licensed Products in the Field, and approve the same with respect the Existing Product or any Co-Promote ProductSection 6.1.3; (kvi) discuss and implement processes and procedures, including under establish a common secure information exchange platform for the Pharmacovigilance Agreement, for purpose of electronically sharing information needed accessible to support each Party’s Party for the receipt, review, investigation, recording, communication, and exchange (or their Affiliates’as between the Parties) respective of Clinical Data and other Information arising from Clinical Studies and regulatory responsibilities and which may be necessary for compliance with the applicable regulatory pharmacovigilance requirements; (l) review and submit to the JSC for approval any New Product Proposalactivities; and (mvii) perform such other functions as are assigned to it in this Agreement set forth herein or as are appropriate to further the purposes Parties may mutually agree in writing, except where in conflict with any provision of this Agreement as agreed in writing by the PartiesAgreement. CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

Specific Responsibilities. In particularaddition to its overall responsibility for the activities under this Agreement, the DWG shallJSC shall in particular: (a) oversee review and coordinate the on-going sharing approve annual updates and transfer of Know-How generated in or related amendments to the Development of Licensed ProductsGDP, including the global regulatory strategy (and amendments and updates thereto) included in the GDP and presented by the JDC; (b) oversee review and discuss, as necessary, the implementation performance of each Party, or a Party’s Affiliate or Sublicensee, as applicable, in performing the activities under the GDP, the Medical Affairs Plan or the Commercialization Plans, including actual financial results versus budget or plan, compliance with applicable Laws and any agreed-upon standards for conduct of such activities and progress of the GDP for each Licensed Product for the Development of such Licensed ProductClinical Studies then on-going; (c) review and update approve the Core Development Plan for each Co-Promote Product and Core Development Budget for such Co-Promote Product set forth therein [***] a year and, from time to time, present to the JSC for review and approval proposed substantive amendments to the Core Development initial US Commercialization Plan, including the Core Development initial US Commercialization Budget, and any amendments and updates to such US Commercialization Plan and US Commercialization Budget, in accordance with Section 4.2.5each case presented to the JSC by the JCC; (d) on a Licensed Productreview and approve the initial Ex-by-Licensed Product basisUS Commercialization Plan and any amendments and updates thereto, develop and propose in each case presented to the JSC for review and approval a regulatory and clinical strategy for such Licensed Product (“Regulatory Strategy”)by the JCC; (e) review and approve the initial Medical Affairs Plan, including the initial Medical Affairs Budget, and any amendments and updates thereto, in each case presented to the JSC by the JMAC; (f) review and approve the Global Branding Strategy, and any amendments and updates thereto, presented by the JCC; (g) oversee the implementation of the Regulatory Strategy for the Regulatory Approval of each Co-Promote Product once it has been approved by Finance Working Group and any other Working Groups that reports into the JSC; (f) in connection with each Co-Promote Option for a Licensed Product, discuss any Phase 1 Clinical Study Report and any proposed Core Development Plan and Core Development Budget for such Licensed Product, along with any amendment to such proposed Core Development Plan and Core Development Budget; (g) provide a forum for the Parties to review and discuss regulatory matters as provided in Section 4.4; (h) review each clinical study design and protocolattempt to resolve disputes within the JDC, including clinical study endpointsthe JCC, clinical methodology and monitoring requirements for each Clinical Study with respect to a Licensed Productthe JMAC, and approve the same with respect the Existing Product Finance Working Group or any Co-Promote Product; (i) review each IND, Drug Approval Application, other major Regulatory Filing, and post-filing requirements with respect to a Licensed Product, and approve the same with respect the Existing Product or any Co-Promote Product; (j) review the design and protocol of and oversee performance of GLP toxicology studies or other studies to support IND filing of Licensed Products in the Field, and approve the same with respect the Existing Product or any Co-Promote Product; (k) discuss and implement processes and procedures, including under the Pharmacovigilance Agreement, for sharing information needed to support each Party’s (or their Affiliates’) respective regulatory responsibilities and which may be necessary for compliance with the applicable regulatory pharmacovigilance requirements; (l) review and submit Working Group that reports to the JSC for approval any New Product ProposalJSC; and (mi) perform such other functions as are assigned to it in this Agreement or as are appropriate to further the purposes of this Agreement as to the extent agreed to in writing by the Parties.