Responsibility; Decision-making. During the Term, TESARO will, including through its Affiliates and Sublicensees, have sole responsibility for and sole decision-making authority with respect to, the research, development, manufacture, marketing, sale and use of Licensed Product in the Field, and except as otherwise expressly set forth in this Agreement, will be responsible for all of the costs and expenses associated with such activities during the Term.
Responsibility; Decision-making. During the Term, Trevi will, including through its Affiliates and Sublicensees, have sole responsibility for and sole decision-making authority with respect to, the research, development, manufacture, marketing, sale and use of Licensed Product in the Field, and except as otherwise expressly set forth in this Agreement, will be responsible for all of the costs and expenses associated with such activities during the Term. Trevi shall use its Commercially Reasonable Efforts to develop and commercialize Licensed Product in the Territory.
Responsibility; Decision-making. The JDCC shall be responsible for (i) establishing and amending the European Co-Development Plan and Budget in accordance with Section 2.2; (ii) overseeing the implementation of such plan, including the preparation and submission of regulatory correspondence and filings; (iii) making the Injection Product Election in accordance with Section 3.1; (iv) overseeing the process of entering into European License(s), if such process is the Injection Product Election as defined in Section 3.1 below; (v) overseeing and monitoring Commercialization by any European Partners; (vi) overseeing publication of results from clinical studies and other Development activities; (vii) establishing and overseeing global pharmacovigilance policy for the Product, including adverse event reporting policy and procedures; and (vii) taking such other actions as are specifically allocated to the JDCC under this Agreement. Any approval, determination or other action of the JDCC shall require agreement of the members of the JDCC, with each Party having one (1) vote. Action that may be taken at a meeting of the JDCC also may be taken without a meeting if a written consent setting forth the action so taken is signed by all members of the JDCC. In the event the JDCC is unable to reach consensus on a particular matter within its jurisdiction, the matter shall be referred to executives of the Parties in accordance with Section 14.1, and if such referral does not resolve such matter, then the dispute shall be resolved via arbitration in accordance with Section 14.2. *** Confidential treatment request pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commission.
Responsibility; Decision-making. The JDCC shall perform the following functions: (i) exchange information concerning the overall strategy and timelines for the Development Plan; (ii) review and evaluate data and progress of the activities under the Development Plan; (iii) resolve disputes or disagreements between the Parties with respect to the Development Plan; (iv) ensure open communication between the Parties as relates to the Development Plan, including making arrangements for a third party service provider to provide for a secure electronic data room to share data, documentation, information and materials generated for or used in the research, development, production or other exploitation of the Compound and Products; (v) make amendments to the Development Plan then in effect; and (vi) taking such other actions as are specifically allocated to the JDCC under this Agreement. Any approval, determination or other action of the JDCC shall require agreement of the members of the JDCC, with each Party having one (1) vote. Action that may be taken at a meeting of the [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. JDCC also may be taken without a meeting if a written consent setting forth the action so taken is signed by all members of the JDCC. In the event the JDCC is unable to reach consensus on a particular matter within its jurisdiction, the matter shall be referred to executives of the Parties in accordance with Section 14.1, and if such referral does not resolve such matter, then the dispute shall be resolved via arbitration in accordance with Section 14.2.
Responsibility; Decision-making. During the Term, XBIO will, including through its Affiliates and Sublicensees and their respective contractors, have sole responsibility for and sole decision-making authority with respect to, the research, development, manufacture, marketing, sale and use of Licensed Product in the Field in the Territory and will be responsible for all of the costs and expenses associated with such activities during the Term. XBIO shall keep CLS reasonably informed as to XBIO’s progress in these efforts and XBIO will use good faith efforts to confer with CLS, on at least a quarterly basis, with respect to the development of the Licensed Product. Without limiting the foregoing, XBIO will use good faith efforts to confer with CLS on significant product development decisions (such as design and conduct of clinical trials, entering into research and development collaborations, and entering into license or sublicense agreements) in advance of making such decisions. During the Term, CLS shall be entitled to one seat on the Scientific Advisory Board of XBIO and may fill that seat with a nominee of its choosing that is reasonably acceptable to XBIO.
Responsibility; Decision-making. During the Term, XBIO will, including through its Affiliates and Sublicensees and their respective contractors, have sole responsibility for and sole decision-making authority with respect to, the research, development, manufacture, marketing, sale and use of Licensed Product in the Field in the Territory and will be responsible for all of the costs and expenses associated with such activities during the Term. XBIO shall keep CLS reasonably informed as to XBIO’s progress in these efforts and XBIO will use good faith efforts to confer with CLS, on at least a quarterly basis, with respect to the development of the Licensed Product. Without limiting the foregoing, XBIO will use good faith efforts to confer with CLS on significant product development decisions (such as design and conduct of clinical trials, entering into research and development collaborations, and entering into license or sublicense agreements) in advance of making such decisions.
Responsibility; Decision-making. The Joint Development Committee shall be responsible for managing the development program for the Compound and the Products in the Field in the Territory, and may amend the Development Plan from time to time in writing. At each Joint Development Committee meeting, at least one member appointed by each of BHV and ISLT must be present to constitute a quorum. Decisions shall be made by unanimous vote based on commercially reasonable judgment, with all the members representing BHV collectively having one vote and all the members representing ISLT collectively having one vote. Any disputes will be raised to the Joint Steering Committee for final decision.
Responsibility; Decision-making. The Joint Commercialization Committee shall be responsible for managing the commercialization program for the Products in the Field in the Territory, and may amend the Commercialization Plan from time to time in writing. At each Joint Commercialization Committee meeting, at least one member appointed by each of BHV and ISLT must be present to constitute a quorum. Decisions shall be made by unanimous vote based on commercially reasonable judgment, with all the members representing BHV collectively having one vote and all the members representing ISLT collectively having one vote. Any disputes will be raised to the Joint Steering Committee for final decision.
Responsibility; Decision-making. The Joint Steering Committee shall have the following responsibilities:
Responsibility; Decision-making. During the Term, **** will, including through **** Affiliates and Sublicensees, have **** responsibility for and **** decision-making authority with respect to, the research, development, manufacture, marketing, sale and use of Licensed Product in the Field, and except as otherwise expressly set forth in this Agreement, will be responsible for **** associated with such activities during the Term.
