Common use of Specific Responsibilities Clause in Contracts

Specific Responsibilities. In particular, the JDC shall: (a) oversee and coordinate the on-going transfer, in accordance with the terms of this Agreement, from Infinity to AbbVie of Infinity Know-How, and from AbbVie to Infinity of AbbVie Know-How, related to the Development of Licensed Compounds 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; (c) 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 GDP, including the Development Budget and the allocation of Development responsibilities between the Parties and present to the JSC for approval proposed amendments to the GDP, including the Development Budget, in accordance with Section 4.1.5; (f) develop and update, on an annual basis, for inclusion in the GDP, the CMC Development plans and the Manufacturing Plans for the pre-clinical and clinical supply of the Licensed Compound and Products in the Territory; (g) review and comment on Regulatory Filings relating to the Products in the Field in accordance with Section 4.4; (h) review and comment on the initial Global Publication Strategy and amendments thereto prepared and presented by the JMAC from time to time in accordance with Section 9.4.1; (i) oversee the Regulatory Working Group, the Pharmacovigilance Working Group, the Manufacturing Working Group, the IP Working Group, the Translational Medicine Working Group and any other Working Groups that reports to the JDC; (j) monitor progress and performance of Development activities under this Agreement, including a review of actual financial results versus budget or plan; and (k) 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 JSC shall continuously monitor the progress of the Development Plan and Budget and provide status reports to the senior management of each of the Parties as appropriate. The Parties contemplate that the responsibilities of the Joint Steering Committee shall evolve during the course of the Parties’ relationship under this Agreement. In particularsupport of its responsibility for overseeing and coordinating the Development and Exploitation of the Licensed Products, the JDC JSC shall: (a) oversee establish a strategy for (i) the Development, Approval, Commercialization and coordinate other Exploitation of the on-going transferLicensed Products in (A) the Human Excluding HIV/AIDS/ID/Pediatric Field in the Salix Human Excluding HIV/AIDS/ID/Pediatric Territory; (B) the HIV/AIDS/Pediatric Field in the Salix HIV/AIDS/Pediatric Territory; and (C) the ID Field in the Salix ID Territory and (ii) the coordination of the Development, Approval, Commercialization and other Exploitation of the Licensed Products in accordance with fields and countries other than those specified in the terms of this Agreement, from Infinity to AbbVie of Infinity Know-How, and from AbbVie to Infinity of AbbVie Know-How, related preceding clause (i) to the Development extent such Development, Approval, Commercialization and other Exploitation impacts or affects the Development, Approval, Commercialization and other Exploitation of the Licensed Compounds and Products so that each Party may undertake Development of Licensed Compounds and Products in accordance with the GDP fields and this Agreementcountries specified in clause (i); (b) coordinate review and monitor the activities of Development Plan and Budget and the implementation thereof and make recommendations to the Parties under regarding updates, amendments and modifications to the GDP Development Plan and oversee the implementation of the GDPBudget; (c) consider the allocation of responsibilities between the Parties for Development pursuant to the extent necessary, share planning Development Plan 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 applicableBudget; (d) develop consider the allocation of responsibilities between the Parties for Commercialization and update, on an annual basis, other Exploitation activities pursuant to one or more written plans covering the proposed global regulatory strategy for the Products in the Field in the Territory, Commercialization and include such proposed strategy in the GDP, for approval by the JSC in accordance with this Agreementother Exploitation of each Licensed Product; (e) on an annual basis, update the GDP, including the Development Budget review and the allocation of Development responsibilities between make recommendations to the Parties regarding the conduct of Clinical Trials for additional indications for Licensed Products, Post Approval Studies for Licensed Products, and present to the JSC for approval proposed amendments to the GDP, including the Development Budget, Plan and Budget in accordance with Section 4.1.5respect thereof; (f) develop and update, on an annual basis, for inclusion in the GDP, the CMC Development review statistical analysis plans and protocols for, and monitor the Manufacturing Plans progress of, all Clinical Trials and Post Approval Studies for the pre-clinical and clinical supply of the Licensed Compound and Products in the TerritoryProducts; (g) review and comment on Regulatory Filings relating make recommendations to the Products in Parties on all proposed product labeling, Drug Approval Applications and other filings with the Field in accordance Regulatory Authorities with Section 4.4respect to Approvals for the Licensed Products; (h) review and comment make recommendations to the Parties on the initial Global Publication Strategy advertising and amendments thereto prepared promotional materials and presented by the JMAC from time to time in accordance with Section 9.4.1strategies, packaging designs and Product Trademarks for each Licensed Product; (i) oversee facilitate the Regulatory Working Group, exchange of Development Information relating to all Clinical Trials and Post Approval Studies and Commercialization Information for the Pharmacovigilance Working Group, the Manufacturing Working Group, the IP Working Group, the Translational Medicine Working Group and any other Working Groups that reports to the JDCLicensed Products; (j) monitor progress and performance of Development activities under this Agreementestablish such other committees (each, including the JSC, a review “Committee”) as deemed appropriate by the JSC, including such Committees as the JSC deems appropriate to coordinate the Development, Approval, Commercialization and other Exploitation of actual financial results versus budget or planthe Licensed Products on a worldwide basis; (k) consider labeling issues and undertake coordination of labeling on a worldwide basis so as to ensure such degree of consistency in labeling as the JSC deems to be desirable; and (kl) perform such other functions as are assigned to it in this Agreement set forth herein or as are appropriate the Parties may mutually agree in writing. For clarity, subject to further the purposes terms of this Agreement as agreed Agreement, the activities and resources of each Party shall be managed by such Party, acting independently and in writing by the Partiesits individual capacity.

Specific Responsibilities. In particular, the JDC shallshall be responsible for the following activities with respect to the Product: (a) oversee and coordinate overseeing the on-going transfer, in accordance with the terms of this Agreement, from Infinity to AbbVie of Infinity Know-Howdevelopment of, and from AbbVie reviewing and revising, if applicable, the GT Operational Plan (and related GT Operational Budget) and Territory Development Plan (and any updates to Infinity any of AbbVie Know-How, related to the Development of Licensed Compounds and Products so that each Party may undertake Development of Licensed Compounds and Products foregoing) for the Product in accordance with the GDP and this AgreementField in the Territory for final approval by the JSC; (b) coordinate the reviewing and overseeing activities of the Parties under the GDP and oversee Development Plans for the implementation of Product in the GDPField in the Territory; (c) overseeing clinical and regulatory matters relating 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 Product in the FieldField in the Territory arising from the Development Plans (including interactions with Regulatory Authorities), and reviewing and approving protocols (including amendments thereto), statistical analysis plans, clinical trial plans (in terms of designs, endpoints, scales, sample sizes, study cohorts, doses and duration), clinical methodology and monitoring requirements for all clinical trials, including post-marketing non-approval trials, of the Product in the Field in the Territory as applicablecontemplated under the Development Plans; (d) develop reviewing and update, on an annual basis, the proposed global regulatory strategy approving ZLAB’s support of any investigator initiated study for the Products Product in the Field in the Territory; (e) reviewing the progress of, and results and data from, ongoing clinical trials under the Development Plans, including ongoing enrollment and budgetary issues and ongoing safety, both protocol-specific and across the Development Plans; provided that Regeneron shall not be required to provide any Proprietary Manufacturing Information to the JDC or ZLAB; (f) reviewing the progress of, and results and data from, Global Trials conducted by or on behalf of Regeneron in the Territory or ROW; provided that with respect to any such Global Trial […***…]; (g) with respect to any Global Trial conducted by or on behalf of ZLAB in the Territory, reviewing and discussing Regeneron’s protocol for such Global Trial (including patient eligibility, sample analysis, and centralized imaging reads), site qualification requirements and any other policies and procedures regarding the conduct of such Global Trial globally (as well as any updates thereto provided by Regeneron) (the “Global Trial Requirements”); (h) with respect to any Global Trial conducted by or on behalf of Regeneron (other than by or on behalf of ZLAB) in the Territory, reviewing and discussing Regeneron’s protocol for such Global Trial; (i) reviewing and discussing the GTC Budgets provided by Regeneron pursuant to Section 5.3.2(b); (j) […***…]; (k) […***…]; (l) evaluating for Development, Manufacturing and Commercialization in the Field in or for the Territory (i) any new doses, forms, formulations, presentations and delivery systems (including Territory Product Changes), (ii) any new proposed Approved Indications and (iii) all other changes or improvements with respect to the Approved Product, in each case ((i), (ii) and (iii)), that a Party may propose from time to time and presenting the same to the JSC; (m) overseeing, monitoring and coordinating the submission of Registration Filings in the Field in the Territory, including reviewing and include such proposed strategy coordinating material communications, filings and correspondence with Regulatory Authorities in the GDP, for approval by Territory in connection with the JSC Product in accordance with this Agreementthe Field; provided that […***…] or […***…] or […***…]; (en) on an annual basis, update the GDP, including the Development Budget developing and the allocation of Development responsibilities between the Parties and present proposing to the JSC for approval proposed amendments to the GDP, including the Development BudgetJSC, in accordance consultation with Section 4.1.5the JCC, the Target Labeling for the Product in the Field (which shall comply with the Global Marketing Guidelines); (fo) develop and update, on an annual basis, reviewing ZLAB’s forecasts for inclusion in the GDP, the CMC quantities of Product required for ZLAB’s Development plans and the Manufacturing Plans for the pre-clinical and clinical supply of the Licensed Compound and Products […***…] in the Territory; (gp) review and comment on Regulatory Filings relating with respect to Regeneron’s Development of the Products Product in the Field Territory, discussing the timing and nature of Regeneron’s and ZLAB’s communications with Regulatory Authorities and key opinion leaders in accordance with Section 4.4; (h) review and comment on the initial Global Publication Strategy and amendments thereto prepared and presented by Territory regarding the JMAC from time to time in accordance with Section 9.4.1; (i) oversee the Regulatory Working Group, the Pharmacovigilance Working Group, the Manufacturing Working Group, the IP Working Group, the Translational Medicine Working Group and any other Working Groups that reports to the JDC; (j) monitor progress and performance of Development activities under this Agreement, including a review of actual financial results versus budget or planProduct; and (kq) perform considering and acting on such other functions matters as are specifically assigned to it in the JDC under this Agreement or as are appropriate to further the purposes of this Agreement as agreed in writing by the PartiesJSC.

Specific Responsibilities. In particularSubject to the oversight of the JSC, the JDC shallshall be responsible for overseeing Development strategy for the Product globally under the Collaboration Agreement and this Agreement, including the following: (a) oversee overseeing the development of goals and coordinate the on-going transfer, in accordance with the terms of this Agreement, from Infinity to AbbVie of Infinity Know-How, and from AbbVie to Infinity of AbbVie Know-How, related to strategy for the Development of Licensed Compounds the Product (including regulatory strategies and Products so that each Party may undertake Development prioritization of Licensed Compounds Clinical Trials and Products in accordance with indications for the GDP Product) for review and this Agreementapproval by the JSC; (b) coordinate overseeing the activities preparation of annual updates to, and other amendments of, the Parties under Global Development Plan for approval by the GDP and oversee the implementation of the GDPJSC; (c) to overseeing the extent necessary, share planning development of goals and budgeting information with strategy for Drug Regulatory Approval Applications for review and approval by 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 applicableJSC; (d) develop preparing the Core Data Sheet pursuant to Section 7.1.6(b) 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 submitting draft to the JSC in accordance with this Agreementfor approval; (e) monitoring compliance with the then-current budget included in the Global Development Plan on an annual a continuing basis, update the GDP, including the Development Budget and the allocation of Development responsibilities between the Parties and present to the JSC for approval proposed amendments to the GDP, including the Development Budget, in accordance with Section 4.1.5; (f) develop reviewing, coordinating and update, on an annual basis, for inclusion monitoring the activities and progress of the Parties in implementing the Development activities in the GDP, the CMC Global Development plans and the Manufacturing Plans for the pre-clinical and clinical supply of the Licensed Compound and Products in the TerritoryPlan; (g) review and comment on Regulatory Filings relating facilitating the flow of information with respect to the Products in Development of the Field in accordance Product and coordinate with Section 4.4other Committees, as appropriate; (h) review and comment on overseeing the initial preparation of recommendations to the JSC for further Development of the Product, including Development for new indications that are not in the then current Global Publication Strategy and amendments thereto prepared and presented by the JMAC from time to time in accordance with Section 9.4.1Development Plan; (i) oversee overseeing the Regulatory Working Groupconduct of Clinical Trials (including Required Phase IV Studies), including approval of the Pharmacovigilance Working Group, the Manufacturing Working Group, the IP Working Group, the Translational Medicine Working Group final version of all Clinical Trial protocols and any other Working Groups that reports to the JDCmaterial amendments thereto; (j) monitor progress subject to the terms of this Agreement and performance the Approved Plans, recommending allocation of responsibilities for Development activities under this Agreement, including a review between Agensys and SGI to the JSC for approval; (k) overseeing the forecasting of actual financial results versus budget or planquantities of Product required for Clinical Trials for incorporation into the Global Manufacturing Plan; (l) providing Quarterly updates on the JDC’s activities and achievements to the JSC; and (km) perform performing such other functions as the JSC may request from time to time or are expressly assigned to it the JDC in this Agreement or as are appropriate to further the purposes of this Agreement as agreed in writing by the PartiesAgreement.

Specific Responsibilities. The JCC shall oversee and coordinate the Commercialization of CNS Compounds and CNS Products in the Territory. In particular, the JDC JCC shall: (a) oversee review and coordinate finalize the onCo-going transferCommercialization Plan and Co‑Commercialization Budget, and material amendments thereto, including any updates to such plan or budget in accordance with the terms of this Agreement, from Infinity to AbbVie of Infinity Know-How, Section ‎5.3.3 (Amendments and from AbbVie to Infinity of AbbVie Know-How, related to the Development of Licensed Compounds and Products so that each Party may undertake Development of Licensed Compounds and Products in accordance with the GDP and this AgreementUpdates); (b) coordinate the activities discuss, review and finalize reasonably in advance of the Parties under first Regulatory Approval for the GDP first CNS Product, and oversee annually thereafter, a non-binding [***] estimated sales forecast for the implementation of the GDPCNS Products; (c) 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 any CNS Product(s) and countries within the DevelopmentCo‑Commercialization Territory with respect to which Denali has exercised the Co‑Commercialization Option, Commercializationprepare and approve, Manufacturing the Parties’ strategies related to field-based medical education activities by either Party and Medical Affairs Activities of Products grant-based medical education programs for such CNS Product(s) in the Field, as applicableeach such country; (d) develop and update, on an annual basis, monitor the proposed global regulatory strategy competitive landscape 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 GDP, including the Development Budget and the allocation of Development responsibilities between the Parties and present to the JSC for approval proposed amendments to the GDP, including the Development Budget, in accordance with Section 4.1.5; (f) develop and update, on an annual basis, for inclusion in the GDP, the CMC Development plans and the Manufacturing Plans for the pre-clinical and clinical supply of the Licensed Compound and CNS Products in the Territory; (e) discuss, review and finalize the Parties’ strategies related to any marketing studies, epidemiological studies, modeling and pharmaco-economic studies, investigator-initiated clinical trials or post-marketing surveillance studies with respect to CNS Products in each country of the Co-Commercialization Territory; (f) discuss pricing of CNS Products; (g) review and comment on Regulatory Filings relating to approve the Detail position for CNS Products in the Field in accordance with Section 4.4conduct of Co-Commercialization Activities; (h) review implement a process for reviewing and comment on the initial Global Publication Strategy and amendments thereto prepared and presented by the JMAC from time to time in accordance with Section 9.4.1; approving (i) oversee the Regulatory Working GroupPromotional Materials and (ii) training materials and programs for sales representatives, the Pharmacovigilance Working Groupin each case (i) and (ii), the Manufacturing Working Group, the IP Working Group, the Translational Medicine Working Group and any other Working Groups that reports are intended for use with Co-Commercialization Products in applicable Co-Commercialization Countries to the JDC; (j) monitor progress and performance of Development activities under this Agreement, including a review of actual financial results versus budget or planextent to which Denali has exercised its Co‑Commercialization Option; and (ki) perform such other functions as are assigned to it set forth in this Agreement as the function of the JCC or as are appropriate to further the purposes of this Agreement as agreed Parties may otherwise mutually agree in writing by the Partieswriting.

Specific Responsibilities. In particularSubject to the oversight of the JSC, the JDC shall: shall be responsible for overseeing Development strategy for the Product globally under this Agreement. The JDC’s responsibilities shall include the following: (a) oversee overseeing the preparation of annual updates and coordinate other amendments to the onGlobal Development Plan (including the budget therefor) for approval by the JSC; (b) subject to Section 8.1.6(a), reviewing and approving a form of Core Data Sheet and submitting a draft thereof to the JSC for its approval pursuant to Section 2.2.3; (c) monitoring compliance with the then-going transfercurrent budget included in the Global Development Plan; (d) reviewing, coordinating and monitoring the activities and progress of the Parties in implementing the Development activities contemplated by the Global Development Plan; (e) monitoring the activities of its Working Groups, including the JMAT, JRT and CDS Working Group in accordance with the terms of this AgreementAgreement (provided, from Infinity for clarity, that despite the JDC’s global role with respect to AbbVie Development, its role with respect to the JMAT and Medical Affairs Activities will be limited to the JMAT’s responsibilities under this Agreement with respect to the Major Markets); (f) in consultation with the JRT, recommending to the JSC whether and when to submit a DAA, including a BLA, for the Product anywhere in the Territory; (g) facilitating the flow of Infinity Know-How, and from AbbVie to Infinity of AbbVie Know-How, related information with respect to the Development of Licensed Compounds the Product and Products so that each Party may undertake Development coordinating such information flow with other Committees, as appropriate; (h) overseeing the strategic planning and conduct of Licensed Compounds and Products in accordance Clinical Trials consistent with the GDP allocation of sponsorship and this Agreement; (b) coordinate responsibility for Clinical Trials set forth in Section 4.6.2; provided, that the activities of the Parties under the GDP and oversee the implementation of the GDP; (c) to the extent necessary, share planning and budgeting information with the JCC and the JMAC and JDC shall coordinate with the JCC and JMAC in preparing comprehensive planning and budgeting proposals JMAT with respect to the DevelopmentJDC’s strategic planning and conduct of Phase III-B Studies and Phase IV Studies; (i) making forecasts of Clinical Supply requirements for Development of the Product and reviewing the supply of Product; (j) making recommendations for further Development of the Product, Commercialization, Manufacturing and Medical Affairs Activities of Products including Development for new indications that are not in the Field, as applicable; then current Global Development Plan; (dk) develop providing Quarterly updates on the JDC’s activities to the JSC; (l) establishing 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 implementing a responsibility assignment matrix consistent with this Agreement; (e) on an annual basis, update Agreement to define the GDP, including the Development Budget roles and the allocation of Development responsibilities between the Parties and present with respect to the JSC for approval proposed amendments to the GDP, including the Development Budget, in accordance with Section 4.1.5; (f) develop and update, on an annual basis, for inclusion in the GDP, the CMC Development plans and the Manufacturing Plans for the pre-clinical and clinical supply of the Licensed Compound and Products in the Territory; (g) review and comment on Regulatory Filings relating to the Products in the Field in accordance with Section 4.4; (h) review and comment on the initial Global Publication Strategy and amendments thereto prepared and presented by the JMAC from time to time in accordance with Section 9.4.1; (i) oversee the Regulatory Working Group, the Pharmacovigilance Working Group, the Manufacturing Working Group, the IP Working Group, the Translational Medicine Working Group and any other Working Groups that reports to the JDC; (j) monitor progress and performance of Development activities under this Agreement, including a review of actual financial results versus budget or planactivities; and (k) 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 JDC DWG shall: (a) oversee and coordinate the on-going transfer, in accordance with the terms sharing and transfer of this Agreement, from Infinity to AbbVie of Infinity Know-How, and from AbbVie to Infinity of AbbVie Know-How, How generated in or related to the Development of Licensed Compounds and Products so that each Party may undertake Development of Licensed Compounds and Products in accordance with the GDP and this AgreementProducts; (b) coordinate the activities of the Parties under the GDP and oversee the implementation of the GDPGDP for each Licensed Product for the Development of such Licensed Product; (c) to the extent necessary, share planning review 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 GDP, including the Core Development Plan for each Co-Promote Product and Core Development Budget and the allocation of Development responsibilities between the Parties and 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 GDPCore Development Plan, including the Core Development Budget, in accordance with Section 4.1.54.2.5; (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) develop in connection with each Co-Promote Option for a Licensed Product, discuss any Phase 1 Clinical Study Report and updateany proposed Core Development Plan and Core Development Budget for such Licensed Product, on an annual basis, for inclusion in the GDP, the CMC along with any amendment to such proposed Core Development plans Plan and the Manufacturing Plans for the pre-clinical and clinical supply of the Licensed Compound and Products in the TerritoryCore Development Budget; (g) provide a forum for the Parties to review and comment on Regulatory Filings relating to the Products discuss regulatory matters as provided in the Field in accordance with Section 4.4; (h) review each clinical study design and comment on protocol, including clinical study endpoints, clinical methodology and monitoring requirements for each Clinical Study with respect to a Licensed Product, and approve the initial Global Publication Strategy and amendments thereto prepared and presented by same with respect the JMAC from time to time in accordance with Section 9.4.1Existing Product or any Co-Promote Product; (i) oversee review each IND, Drug Approval Application, other major Regulatory Filing, and post-filing requirements with respect to a Licensed Product, and approve the Regulatory Working Group, same with respect the Pharmacovigilance Working Group, the Manufacturing Working Group, the IP Working Group, the Translational Medicine Working Group and Existing Product or any other Working Groups that reports to the JDCCo-Promote Product; (j) monitor progress review the design and protocol of and oversee performance of Development activities 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 this the Pharmacovigilance Agreement, including a 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 of actual financial results versus budget or planand submit to the JSC for approval any New Product Proposal; and (km) 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.