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. 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. 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 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. 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. Individuals engaged at this level may have a range of tasks to be completed, generally by following established procedures. Individuals have some discretion in establishing priorities provided the work is done within agreed timeframes. Problems that may arise at this level are either referred to a more senior staff member for guidance or resolved by following established procedures. More experienced individuals within this level may exercise judgment in applying procedures to resolve an issue.
Responsibility; Decision-making. Individuals engaged at this level typically operate within specific objectives and interpret established work procedures to resolve operational issues. Individuals are strongly encouraged to show initiative in making suggestions to improve work processes and contribute to the enhancement of established procedures. Individuals will have considerable discretion in establishing priorities. Roles at this level will require interpretive skills to enhance existing procedures and precedents to the work situation.
Responsibility; Decision-making. Individuals engaged at this level typically operate within a clearly defined job purpose through operational procedures. Many roles will require positions at this level to modify or adapt work processes on a recurring or regular basis. Level 3 roles are likely to be engaged in frequent resolution of problems. Incumbents need to weigh alternative courses of action and make recommendations accordingly.
Responsibility; Decision-making. Individuals engaged at this level develop and modify policies, programs and initiatives often in the absence of definitive operational procedures. Where guidelines and precedent exist, a variety of alternatives will be considered, taking account of broader organisational priorities to recommend the best approach.
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.
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.
