Common use of Specific Responsibilities of the JMC Clause in Contracts

Specific Responsibilities of the JMC. The responsibilities of the JMC will be to: (a) generally facilitate flow of information between the Parties with respect to technical development and Manufacturing clinical supply of Candidates and Products to NVS, and, if applicable, commercial supply; (b) coordinate and oversee the complete Manufacturing Know-How transfer related to each Candidate and Product to the NVS CMC Sub-Team, including with respect to host cell line history, raw materials used for cultivation, available licenses for commercial use, details about vectors, and process and analytical methods applied to Candidates and Products; (c) coordinate, oversee, and approve the type and amount of assistance to be provided by or on behalf of HMI to NVS for any HMI Manufacturing Know-How transfer support requested by NVS pursuant to Section 8.6.2 (Manufacturing Technology Transfer to NVS) to permit NVS to Manufacture such Candidate(s) and Product(s); (d) update NVS about the progress of the HMI facility build-up, or the need to engage Designated CMOs, as appropriate; (e) provide transparency on planning and budget requirements with respect to preclinical and clinical supplies of Candidates and Products to permit each Party to meet its internal budget and planning processes; (f) facilitate and align the Parties’ activities related to any NVS quality assurance audits of HMI’s and Designated CMOs’ facilities, including following up on critical audit findings and supporting the identification and implementations of potential solutions; (g) select and approve the list of Designated CMOs; (h) advise on the material terms of agreements entered into between HMI and Designated CMOs; (i) oversee negotiation of the Development Supply Agreement, Commercial Supply Agreement, In-Vivo [***] Commercial Supply Agreement, and Quality Agreements, as appropriate; and (j) perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties.

Specific Responsibilities of the JMC. The responsibilities of the JMC will be to: (a) generally facilitate flow of information between the Parties with respect to technical development and Manufacturing clinical supply of Candidates and Products to NVS, and, if applicable, commercial supply; (b) coordinate and oversee the complete Manufacturing Know-How transfer related to each Candidate and Product to the NVS CMC Sub-Team, including with respect to host cell line history, raw materials used for cultivation, available licenses for commercial use, details about vectors, and process and analytical methods applied to Candidates and Products; (c) coordinate, oversee, and approve the type and amount of assistance to be provided by or on behalf of HMI to NVS for any HMI Manufacturing Know-How transfer support requested by NVS pursuant to Section 8.6.2 (Manufacturing Technology Transfer to NVS) to permit NVS to Manufacture such Candidate(s) and Product(s); (d) update NVS about the progress of the HMI facility build-up, or the need to engage Designated CMOs, as appropriate; (e) provide transparency on planning and budget requirements with respect to preclinical and clinical supplies of Candidates and Products to permit each Party to meet its internal budget and planning processes; (f) facilitate and align the Parties’ activities related to any NVS quality assurance audits of HMI’s and Designated CMOs’ facilities, including following up on critical audit findings and supporting the identification and implementations of potential solutions; (g) select and approve the list of Designated CMOs; (h) advise on the material terms of agreements entered into between HMI and Designated CMOs; (i) oversee negotiation of the Development Supply Agreement, Commercial Supply Agreement, In-Vivo [***] SCD Commercial Supply Agreement, and Quality Agreements, as appropriate; and (j) perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties.

Specific Responsibilities of the JMC. The responsibilities of JMC shall have the JMC will be tofollowing responsibilities: (a) generally facilitate flow of information between the Parties with respect to technical development and Manufacturing clinical supply of Candidates and Products to NVS, and, if applicable, commercial supply; (b) coordinate and oversee the complete Manufacturing Know-How transfer related to each Candidate and Product to the NVS CMC Sub-Team, including with respect to host cell line history, raw materials used for cultivation, available licenses for commercial use, details about vectors, and process and analytical methods applied to Candidates and Products; (c) coordinate, oversee, and approve the type and amount of assistance to be provided by or on behalf of HMI to NVS for any HMI Manufacturing Know-How transfer support requested by NVS pursuant to Section 8.6.2 (Manufacturing Technology Transfer to NVS) to permit NVS to Manufacture such Candidate(s) and Product(s); (d) update NVS about the progress of the HMI facility build-up, or the need to engage Designated CMOs, as appropriate; (e) provide transparency on planning and budget requirements with respect to preclinical and clinical supplies of Candidates and Products to permit each Party to meet its internal budget and planning processes; (f) facilitate and align the Parties’ activities related to any NVS quality assurance audits of HMI’s and Designated CMOs’ facilities, including following up on critical audit findings and supporting the identification and implementations of potential solutions; (g) select and approve the list of Designated CMOs; (h) advise on the material terms of agreements entered into between HMI and Designated CMOs; (i) oversee negotiation and approve the selection of CMOs for the Manufacturing of Licensed Compound and Licensed Products in accordance with Section 6.1 and Section 6.2; (ii) oversee clinical and commercial supply of the Development Licensed Products (in accordance with the Quality Agreements and Supply Agreement, Commercial Supply Agreement, In-Vivo [***] Commercial Supply AgreementAgreements entered into pursuant to Section 6.3); (iii) review capital investments specifically relating to the Licensed Products, and Quality Agreementson an annual basis, the overall capital plans for the manufacturing facilities and inclusion of such capital investments in the Manufacturing Budget as part of the Joint Development Budget or the Joint Commercialization Budget, as appropriateapplicable; (iv) review, and recommend for approval by the JSC, the Supply Plan; (v) oversee pharmaceutical development, including the assignment of representatives from both parties to technical sub-teams, (vi) oversee packaging/labeling, distribution, and clinical supply planning for the Licensed Products; (vii) discuss terms of the manufacturing agreements with the selected CMOs; (viii) where applicable, review and approve the Technology Transfer plan (including the associated budget) and manage the activities thereunder; (ix) develop clinical supply forecasting requirements for Licensed Products with the JDC; (x) develop commercial supply forecasting requirements for Licensed Products with the JCC; (xi) develop, for inclusion in the Joint Development Budget or Joint Commercialization Budget, as applicable, each annual budget for Manufacturing Costs and pharmaceutical development for the Licensed Product (the “Manufacturing Budget”) and any updates thereto; (xii) review actual Manufacturing Costs versus the Manufacturing Budget on a quarterly basis; (xiii) reviewing results of regulatory and environmental, health, and safety inspections and audits related to the Manufacture of Licensed Products and reviewing steps taken by either Party to address any deficiencies noted; and (jxiv) perform such other functions as appropriate to further the purposes of this Agreement Agreement, as determined directed by the PartiesJSC in accordance with Section 2.2(c)(xi).

Specific Responsibilities of the JMC. The responsibilities In support of its responsibility for overseeing the manufacturing of Licensed Product on a worldwide basis, the JMC will be toshall perform the following activities: (ai) generally facilitate flow delineate requirements and responsibilities for development and licensure of information between manufacturing processes and facilities for Licensed Product and for supply of Licensed Product in the Parties Territory; (ii) jointly develop a manufacturing strategy for the Development Plan and Annual Plan and Budget to enable development and licensure of manufacturing processes and facilities for Licensed Product in the Territory that includes all aspects of manufacture and release, including but not limited to formulations, Intermediate, dosage form, devices, product characterization studies, stability studies and manufacturing plans and forecasts; (iii) determine Manufacturing Plans and Budgets, and [*] for and [*] such plans in accordance with this Agreement; (iv) [*] process development plans prior to the manufacture of registration batches of Licensed Product; (v) review quality assurance efforts, including but not limited to those efforts with respect to technical development the establishment of Specifications and Manufacturing clinical supply of Candidates and Products to NVS, and, if applicable, commercial supplyquality standards for Licensed Product; (bvi) subject to Section 2.5(b)(xiv), [*] the [*] any [*] that [*] Intermediate, E2F Decoy, Vialed Product, Licensed Device or Final Product [*] Licensed Product; (vii) coordinate with the RWG the drafting and oversee contents of the complete Chemistry, Manufacturing Know-How transfer and Controls section of a Drug Approval Application for Licensed Product; (viii) review [*] plans for any changes in [*], and [*] for Licensed Product, it being understood that [*] regarding the [*] shall be [*] any component of a Licensed Product, if [*] of a Licensed Product pursuant to this Agreement or any related supply agreement, shall [*]; (ix) prepare for regulatory inspections and ensure adherence to each Candidate and Product to the NVS CMC Sub-Team, including compliance standards with respect to host cell line history, raw materials used for cultivation, available licenses for commercial use, details about vectors, and process and analytical methods applied to Candidates and ProductsLicensed Product; (cx) coordinateensure that future logistical strategies and capacity planning are consistent with the forecasts provided in the Pre-Launch Marketing Plan and Budget and each Marketing Plan and Budget, oversee, and approve the type and amount of assistance to be provided by or on behalf of HMI to NVS as well as inventory levels for any HMI Manufacturing Know-How transfer support requested by NVS pursuant to Section 8.6.2 (Manufacturing Technology Transfer to NVS) to permit NVS to Manufacture such Candidate(s) and Product(s)Licensed Product; (dxi) update NVS about review quality-related issues concerning the progress of Licensed Product or any component thereof; (xii) coordinate with the HMI facility build-upJCC, or the need to engage Designated CMOs, JDC and JFC as appropriate; (exiii) provide transparency on planning and budget requirements with respect to preclinical and clinical supplies of Candidates and Products to permit each Party to meet its internal budget and planning processes; (f) facilitate and align the Parties’ activities related to any NVS quality assurance audits of HMI’s and Designated CMOs’ facilities, including following up on critical audit findings and supporting the identification and implementations of potential solutions; (g) select and approve the list of Designated CMOs; (h) advise updates on the material terms of agreements entered into between HMI JMC's activities and Designated CMOs; (i) oversee negotiation of achievements to the Development Supply Agreement, Commercial Supply Agreement, In-Vivo [***] Commercial Supply Agreement, and Quality AgreementsJSC, as appropriate; and (jxiv) perform such other functions as appropriate review [*] any significant agreements, purchase orders or amendments (generally involving [*] of [*]) with Third Parties to further be [*] the purposes manufacture of this Agreement as determined by Intermediate, E2F Decoy, Vialed Product, Licensed Device or Final Product for sale and use in the PartiesTerritory.