Common use of Responsibilities and Authority Clause in Contracts

Responsibilities and Authority. The JSC’s overall responsibility shall be to encourage and facilitate ongoing cooperation and communication between the Parties and to perform the other obligations specifically delegated to it by this Agreement, subject to the limitations set forth in this Article 3. In particular, the JSC shall: (a) review, coordinate, and discuss the overall strategy for obtaining Regulatory Approvals, Pricing Approvals and reimbursement status for the Product in the Field in the Territory; (b) review and discuss the protocols for any Post-Approval and/or Reimbursement Study to be conducted by or on behalf of Cardiome or any of its Affiliates, subject to Section 5.2 hereof; (c) review and discuss ongoing and planned Commercialization activities and spending in the Territory, including, without limitation, countries in which Product will be launched and priority thereof, pre-launch activities, retention of reimbursement consultant(s), efforts to obtain Pricing Approvals and reimbursement status, sales and marketing commitment and strategy, use and distribution of Promotional Materials and Non-Commercial Product, reimbursement and third-party payor status, and product distribution logistics; (d) determine the number of Non-Commercial Product samples to be supplied by SteadyMed, whether for the Launch Period or otherwise; (e) review progress of Commercialization activities and metrics with respect to Product in the Field in the Territory against Commercialization Plans; (f) ensure consistency of Commercialization activities in the Territory with SteadyMed’s global marketing strategy and efforts for the Product; (g) monitor Cardiome inventory levels of Supplied Items; (h) provide a forum for discussion of Product Manufacturing and supply matters, subject to Article 4 hereof; and (i) perform such other duties as are specifically assigned by the Parties to the Joint Steering Committee pursuant to this Agreement. Each Party shall be responsible for ensuring that, at all times, its representatives on the JSC act reasonably and in good faith in carrying out their respective responsibilities hereunder.

Responsibilities and Authority. The JSCSOC’s overall responsibility shall be to oversee and to encourage and facilitate ongoing cooperation and communication between the Parties parties regarding the Programs and the further development of Development Candidates and to perform the other obligations specifically delegated to it by this Agreement, subject to the limitations set forth in this Article 32. In particular, the JSC SOC shall: (a) review, coordinate, meet periodically to discuss Proposed PTPs for selection as Program Target Profiles for Aurigene to generate and discuss the overall strategy for obtaining Regulatory Approvals, Pricing Approvals and reimbursement status for the Product in the Field in the Territoryconduct R&D Plans; (b) review the initial R&D Plan for each Program and discuss the protocols for any Post-Approval and/or Reimbursement Study to be conducted by or on behalf of Cardiome or any of its Affiliatesthereafter periodically review such R&D Plan, and, subject to Section 5.2 hereofSections 2.5 and 2.6, update or amend such R&D Plan as needed from time to time; (c) review and discuss ongoing and planned Commercialization activities and spending in the Territory, including, without limitation, countries in which Product will initial Target Molecular Profile criteria to be launched and priority thereof, pre-launch activities, retention of reimbursement consultant(s), efforts to obtain Pricing Approvals and reimbursement status, sales and marketing commitment and strategy, use and distribution of Promotional Materials and Non-Commercial Product, reimbursement and third-party payor statusmet by a Program Compound for designation as a Development Candidate, and product distribution logisticsreview updates or amendments thereto from time to time; (d) review the results of activities under each R&D Plan to determine whether a particular Program Compound meets the number of Non-Commercial Product samples to be supplied by SteadyMed, whether for the Launch Period applicable Lead Candidate criteria or otherwiseDevelopment Candidate criteria set forth in such R&D Plan; (e) review progress of Commercialization activities and metrics with respect to Product discuss any technical feasibility issues that may arise in the Field in the Territory against Commercialization Plansperformance of an R&D Plan and consider whether any amendment to such R&D Plan is necessary or advisable; (f) ensure consistency of Commercialization activities in subject to Sections 2.5, 2.6 and 5.1, review and discuss the Territory with SteadyMed’s global marketing strategy and efforts initial Development Plan generated by Curis for the Producteach Licensed Program; (g) monitor Cardiome inventory levels provide a forum for review and discussion of Supplied Itemsthe initial Target Product Profile criteria for a Licensed Program; (h) provide a forum for Aurigene to keep Curis reasonably informed of the progress and results of Aurigene’s discovery and research activities with respect to any Aurigene Immuno-oncology PTPs or Follow-On Molecule Profiles; (i) review each Aurigene Immuno-oncology PTP Data Package, Follow-On Molecule Data Package and Development Candidate Data Package within the time period requested by the Alliance Managers and prior to expiration of the relevant Data Package Review Period or the Option Period to determine whether the Information submitted is sufficient to meet the requirements of an Aurigene Immuno-oncology PTP Data Package, Follow-On Molecule Data Package and Development Candidate Data Package, and, if such Information is determined not to meet the requirements of the applicable Data Package, identify the data and information necessary to meet such requirements; (j) provide a forum for review and discussion of: (i) the results of Product Manufacturing R&D Plan activities, including the data and supply mattersinformation included in each Development Candidate Data Package delivered by Aurigene; (ii) the data and information included in each Aurigene Immuno-oncology PTP Data Package and Follow-On Molecule Data Package generated by Aurigene; (iii) the results of Development Plan activities conducted by Curis; (iv) updates by Curis with respect to any contemplated changes in the Development Plan; and (v) updates by Curis with respect to expected resource requirements for contemplated development activities, subject other than those to Article 4 hereofbe performed by Aurigene; (k) review publication strategy with respect to Program Technology as contemplated by Section 8.5(a); and (il) perform such other duties as are specifically assigned by the Parties to the Joint Steering Committee pursuant to outlined in this Agreement. Each Party shall be responsible for ensuring that, at all times, its representatives on the JSC SOC act reasonably and in good faith in carrying out their respective responsibilities hereunder.