Development Responsibilities. From and after the Effective Date, BMS shall assume sole responsibility for the Development of Compounds and Products in the Field in the Territory during the Term at its own cost and expense (including responsibility for all funding, resourcing and decision-making, subject to Sections 3.3 and 3.4), except with respect to the performance by Ambrx of the Research Program activities assigned to Ambrx pursuant to the Research Plan and as otherwise may be agreed upon by the Parties in writing. BMS, by itself or through its Affiliates and Sublicensees, shall use Diligent Efforts to Develop a Compound or Product in the Field in accordance with the Development Plan for the purpose of obtaining a Regulatory Approval in each Major Market. For clarity, it is understood and acknowledged that Diligent Efforts in the Development of Compounds and Products may include sequential implementation of Clinical Trials and/or intervals between Clinical Trials for data interpretation and clinical program planning and approval.
Development Responsibilities. The JDC shall reasonably allocate Development responsibilities of the Compound and Products under the GDP between the Parties and such allocation shall be set forth in the GDP, provided that: (a) Exelixis shall be the Sponsor and have the operational responsibility for all Development work under the GDP that is ongoing as of the Effective Date; (b) each Party shall have the operational responsibility for its own Independent Work; and (c) Licensee shall be the Sponsor and have the operational responsibility for the Licensee Only Development Work and Exelixis shall be the Sponsor and have the operational responsibility for the Exelixis Only Development Work.
Development Responsibilities. Except for CytomX’ responsibilities in the conduct of the Preclinical Development Program, BMS shall have the sole right and responsibility for the Development of Compounds and Products in the Field in the Territory during the Term at its own cost and expense (including responsibility for all funding, resourcing and decision-making), including whether to advance Compounds into Development and to terminate this Agreement with respect to a Collaboration Target. BMS, by itself or through its Affiliates and Sublicensees, shall use Diligent Efforts to Develop and obtain Regulatory Approval for at least one Compound or Product in the Field for each Collaboration Target in accordance with a development plan for the purpose of obtaining a Regulatory Approval in the Major Markets.
Development Responsibilities. Subject to the terms and conditions of this Agreement, including this Article 3 (Development) and Section 5.5 (Decision-Making; Escalation to Senior Officers), Lian will have sole authority to, at its own expense, Develop the Licensed Product for the purpose of obtaining Regulatory Approval in the Field in the Territory. Lian will be responsible for the day-to-day implementation of any Development activities for which it (or any of its Affiliates) is assigned responsibility under this Agreement (including the Development Plans).
Development Responsibilities. The JSC shall select the lead development party (“Lead Development Party”) for each Clinical Trial of a Collaboration Product, provided that Trubion shall be the initial Lead Development Party for all Clinical Trials and Non-Clinical Studies of TRU-016 that are on-going as of the Signing Date. The JSC shall, in allocating Lead Development Party responsibilities between the Parties: (a) endeavor to take advantage of the respective resources, capabilities and expertise of Facet and Trubion; (b) endeavor to (i) maintain, to the extent reasonably practical and appropriate, continuity in functions and commitments of personnel and physical resources of the Parties, (ii) avoid duplication of efforts by the Parties and (iii) xxxxxx efficient use by the Parties of resources and personnel, consistent with this Agreement and the Development Plan and Development Budget; and (c) act in the best interests of the Collaboration. The Lead Development Party shall be responsible for implementing the Development Plan with respect to the applicable Clinical Trial, provided that the other Party shall perform all tasks with respect to such Clinical Trial that are allocated to it pursuant to the Development Plan and may direct and conduct certain additional Development activities not specifically allocated to either Party pursuant to the Development Plan, if the JDC agrees upon such allocation. The Lead Development Party shall not have the right to change the Development Plan or to make changes to the Clinical Trial protocol or the statistical analysis plan or make changes that affect study design or Clinical Trial strategy (any of the foregoing actions falling under the authority of the JDC or JSC, as applicable).
Development Responsibilities. As between the Parties, Reneo shall have sole authority and responsibility for conducting or having conducted Development activities with respect to Compounds and Licensed Products in the Territory, at its sole cost and expense, in accordance with the terms and conditions of this Agreement. Reneo shall conduct all such activities in compliance in all material respects with all applicable Laws. Reneo shall have sole responsibility and control with respect to seeking Regulatory Approvals with respect to Licensed Products. As between the Parties, Reneo shall hold legal title to all Regulatory Materials within the Territory. Promptly following the Effective Date, vTv shall take and cause to be taken such actions and execute such documents that are requested in writing by Reneo to the extent necessary to transfer to Reneo all Regulatory Materials within the vTv Know-How.
Development Responsibilities. KHK shall, during the Term, have sole authority and responsibility for the Development of Products in the Field in the Territory, including the conduct of Clinical Trials of Product in the Territory in support of Regulatory Approval in the Territory (collectively, “Territory Trials”). In the event that Syndax or its designee conducts a global Clinical Trial in countries including the United States and Europe for ***, KHK, in its sole discretion, shall have the right to join such global Clinical Trial.
Development Responsibilities. For each Development Compound developed by Xxxxxx, its Affiliates and sublicensees, Xxxxxx shall be solely responsible, and shall bear the full cost and expense, for the clinical development, governmental approval, manufacturing, marketing and sale of such Development Compound and/or related Product. Xxxxxx agrees to use reasonable commercial efforts to pursue the clinical development, governmental approval, manufacturing, marketing and sale of each Development Compound or Product, as applicable, resulting from the Research Program, and for which it has rights; provided that Xxxxxx may hold a Candidate Compound in reserve as a back-up for a Development Compound or Product in accordance with Section 9.1 above. As used herein, “reasonable commercial efforts” shall mean efforts which are consistent with those utilized by Xxxxxx for its own internally-developed or in-licensed pharmaceutical products of similar relative efficacy and safety profile and similar market potential, at a similar stage of its product life, taking into account the existence of other competitive products in the marketplace or under development, the proprietary position of the product, the anticipated profitability of the product and other relevant factors. Xxxxxx’x obligation to pursue clinical development, governmental approval, manufacturing, marketing and sales of a Development Compound or Product shall not apply with respect to a Candidate Compound which is a backup for a Development Compound or Product in accordance with Section 9.1 above.
Development Responsibilities. As between the Parties, Lumena shall have sole authority and responsibility for conducting or having conducted Development activities with respect to Compounds and Licensed Products in the Territory, at its sole cost and expense, in accordance with the terms and conditions of this Agreement. Lumena shall conduct all such activities in compliance in all material respects with all applicable Laws. Lumena shall have sole responsibility and control with respect to seeking Regulatory Approvals to Commercialize the Licensed Products. As between the Parties, Lumena shall hold legal title to all Regulatory Materials within the Territory. Promptly following the Effective Date, Sanofi shall take and cause to be taken such actions and execute such documents that are requested in writing by Lumena to the extent necessary to transfer to Lumena all Regulatory Materials within the Sanofi Know-How.
Development Responsibilities. Unless the Parties agree in writing upon an alternative allocation of responsibilities, the Parties shall have the following rights and obligations with respect to the conduct of the Studies:
(a) BMS and Pfizer Responsibilities. BMS and/or Pfizer shall be responsible for:
(i) manufacturing and supplying cGMP-grade Apixaban required for the Studies (with such manufacturing to be undertaken by BMS pursuant to Article 4);
(ii) providing Portola with the right of reference to regulatory materials of Apixaban that are reasonably necessary to conduct the Studies and to facilitate the Regulatory Approval for PRT064445 use as an antidote for Apixaban;
(iii) [*] the Preclinical Studies directed by Regulatory Authorities or otherwise agreed upon by the JCC;
(iv) [*] protocols and amendments relating to the use of Apixaban in the Clinical Trial;
(v) [*] the resulting Clinical Trial data relating to Apixaban;
(vi) providing [*] with respect to [*], which [*] may be provided by BMS or Pfizer [*];
(vii) [*] management of the Clinical Trial;
(viii) performing the regulatory activities as set forth in Section 6.1(c); and
(ix) performing such Preclinical Studies as the JCC (by mutual agreement) assigns to BMS or Pfizer and that BMS or Pfizer agrees to carry out (it being understood that the Clinical Study shall remain the responsibility of Portola).
