Common use of Responsibilities and Authority Clause in Contracts

Responsibilities and Authority. The SOC’s overall responsibility shall be to oversee and to encourage and facilitate ongoing cooperation and communication between the 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 2. In particular, the SOC shall: (a) meet periodically to discuss Proposed PTPs for selection as Program Target Profiles for Aurigene to generate and conduct R&D Plans; (b) review the initial R&D Plan for each Program and thereafter periodically review such R&D Plan, and, subject to Sections 2.5 and 2.6, update or amend such R&D Plan as needed from time to time; (c) review the initial Target Molecular Profile criteria to be met by a Program Compound for designation as a Development Candidate, and review 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 applicable Lead Candidate criteria or Development Candidate criteria set forth in such R&D Plan; (e) discuss any technical feasibility issues that may arise in the performance of an R&D Plan and consider whether any amendment to such R&D Plan is necessary or advisable; (f) subject to Sections 2.5, 2.6 and 5.1, review and discuss the initial Development Plan generated by Curis for each Licensed Program; (g) provide a forum for review and discussion of the 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 R&D Plan activities, including the data and information 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, other than those to be performed by Aurigene; (k) review publication strategy with respect to Program Technology as contemplated by Section 8.5(a); and (l) perform such other duties as outlined in this Agreement. Each Party shall be responsible for ensuring that, at all times, its representatives on the SOC act reasonably and in good faith in carrying out their respective responsibilities hereunder.

Responsibilities and Authority. The SOCJSC’s overall responsibility shall be to oversee and to encourage and facilitate ongoing cooperation and communication between the parties regarding the Programs and the further development of Development Candidates Parties and to perform the other obligations specifically delegated to it by this Agreement, subject to the limitations set forth in this Article 23. In particular, the SOC JSC shall: (a) meet periodically to review, coordinate, and discuss Proposed PTPs the overall strategy for selection as Program Target Profiles obtaining Regulatory Approvals, Pricing Approvals and reimbursement status for Aurigene to generate and conduct R&D Plansthe Product in the Field in the Territory; (b) review and discuss the initial R&D Plan protocols for each Program and thereafter periodically review such R&D Plan, andany Post-Approval and/or Reimbursement Study to be conducted by or on behalf of Cardiome or any of its Affiliates, subject to Sections 2.5 and 2.6, update or amend such R&D Plan as needed from time to timeSection 5.2 hereof; (c) review and discuss ongoing and planned Commercialization activities and spending in the initial Target Molecular Profile criteria Territory, including, without limitation, countries in which Product will be launched and priority thereof, pre-launch activities, retention of reimbursement consultant(s), efforts to be met by a Program Compound for designation as a Development Candidateobtain 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 review updates or amendments thereto from time to timeproduct distribution logistics; (d) review determine the results number of activities under each R&D Plan Non-Commercial Product samples to determine be supplied by SteadyMed, whether a particular Program Compound meets for the applicable Lead Candidate criteria Launch Period or Development Candidate criteria set forth in such R&D Planotherwise; (e) discuss any technical feasibility issues that may arise review progress of Commercialization activities and metrics with respect to Product in the performance of an R&D Plan and consider whether any amendment to such R&D Plan is necessary or advisableField in the Territory against Commercialization Plans; (f) subject to Sections 2.5, 2.6 ensure consistency of Commercialization activities in the Territory with SteadyMed’s global marketing strategy and 5.1, review and discuss efforts for the initial Development Plan generated by Curis for each Licensed ProgramProduct; (g) provide a forum for review and discussion monitor Cardiome inventory levels of the initial Target Product Profile criteria for a Licensed ProgramSupplied Items; (h) provide a forum for Aurigene discussion of Product Manufacturing and supply matters, subject 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 R&D Plan activities, including the data and information 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, other than those to be performed by Aurigene; (k) review publication strategy with respect to Program Technology as contemplated by Section 8.5(a)Article 4 hereof; and (li) perform such other duties as outlined in 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 SOC JSC act reasonably and in good faith in carrying out their respective responsibilities hereunder.