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 or its designee 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 in its Territory; and (c) Collaborator shall be the Sponsor and have the operational responsibility for the Collaborator Local Development Work and Exelixis or its designee shall be the Sponsor and have the operational responsibility for the Exelixis Local Development Work.
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) foster 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. Proton shall design, develop ----------------------------- and manufacture the Systems substantially in accordance with the Specifications. Matheson shall select commercial names and design the trademarks and trade dress for the Systems, and supply Proton such names, trademarks and trade dress designs for use in the manufacturing of the Systems.
Development Responsibilities. All decisions regarding the Combined Phase III Clinical Trial in the Territory in the Field, including but not limited to formulation of overall development plans, making overall decisions regarding the design of all clinical trials in the Territory, management of clinical team activity, and management of regulatory activity shall be made through the Steering Committee, Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential treatment under Rule 406 of the Securities Act. subject to the dispute resolution mechanism set forth in Section 16.1 below. Prior to the Combined Phase III Clinical Trial, ALTUS shall keep the Steering Committee informed of the progress of the clinical development, including development plans, time lines and process development work, and will discuss with the Steering Committee developments and decisions that ALTUS anticipates will have a significant impact on the Combined Phase III Clinical Trial and/or Regulatory Approvals in the Territory.
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. Biosite and Merck shall conduct the Development Program under the direction of the Steering Committee. Biosite shall be responsible for the design, development and manufacturing scale-up of the Reagents and the Testing Device, the clinical trials and regulatory approval of the Product for use in the Field in the United States of America and Canada. Merck shall be responsible for the clinical trials and regulatory approval of the Product for use in the Field in the countries of Europe and Latin America and in South Africa. Biosite shall be responsible for the clinical trials and regulatory approval of the Product for use in the Field in Japan and the rest of the world. Pursuant to the Reader Development and Supply Agreement, LRE shall be responsible for the design and development of the Reader. Biosite and Merck shall cooperate with LRE in the design and development of the Reader.
Development Responsibilities. Biosite shall be responsible to conduct or cause the design, development and manufacturing scale-up of the Product. Biosite shall be responsible for the clinical trials and regulatory approval of the Product in the United States of America. KDK shall be responsible for the clinical trials and regulatory approval of the Product in the Territory for use in the Field.
Development Responsibilities. Conor shall have the sole right and responsibility, at its expense, to perform all preclinical, clinical, and other development activities necessary to commercialize Conor Devices incorporating Product, including, without limitation, conducting preclinical research and clinical trials within the Field of Use. Conor shall have sole control over the development (including, without limitation, the clinical development) of all Conor Devices incorporating Product.