Responsibility for Development. BI shall remain solely responsible for Development and continue to have sole responsibility for all Development activities even if Vitae exercises its Co-Development Option.
Responsibility for Development. As between the Parties, Lilly shall have the sole right and responsibility, at its sole cost and expense, for the conduct of all Development activities applicable to any Licensed Product in the Territory, including the Manufacture and supply of such Licensed Product in such quantities as required for such Development activities pursuant to this Agreement (subject to Sigilon’s manufacturing rights and obligations under Article 7).
Responsibility for Development. Except as otherwise set forth in this Section 4.1 (Responsibility for Development), from and after the Effective Date, responsibility for Development shall be as set forth in the Existing License Agreement. Amgen will be the “Development Lead” for the Product for the United States and shall have primary responsibility for Development activities for the Product in the United States in accordance with the applicable Development Plan and Development Budget, and Novartis shall provide both strategic input and operational support for such activities as agreed in the applicable Development Plan and Development Budget. For clarity, without the prior written consent of Novartis, Amgen shall not undertake any Development activities in the Amgen Territory that would [*] or the US Collaboration. 4.2
Responsibility for Development. Licensee shall be solely responsible for the activities of clinical development related to Licensed Products in the Territory under the terms of this Agreement (other than the Xxxxxxx AR Mutant Activities), including any post-marketing surveillance studies or Clinical Trials eventually required by Regulatory Authorities or any studies voluntarily undertaken by Licensee.
Responsibility for Development. Except as otherwise set forth in this Section 5.1 (Responsibility for Development), from and after the Effective Date, with respect to Franchise Product 1 and Franchise Product 2, and from and after Option Exercise Date, with respect to Franchise Product 3, the Parties will share responsibility for day-to-day Development activities for each Licensed Product worldwide in accordance with the applicable Development Plan and Development Budget, including generating protocols subject to the JSC’s review and approval, conducting clinical trials, and data collection, verification and analysis. Solely with respect to Franchise Product 1 prior to receipt of the first Regulatory Approval therefor in the U.S., (i) Amgen shall be the Development lead and shall have primary responsibility for day-to-day Development activities relating thereto worldwide in accordance with the applicable Development Plan and Development Budget and (ii) Novartis shall provide both strategic input and operational support for such activities as agreed in the applicable Development Plan and Development Budget; provided that, notwithstanding the foregoing, Novartis shall have those responsibilities with respect to Franchise Product 1 and Franchise Product 2 as set forth in the RACI Documents, including with respect to [*]. In the event of a conflict between the terms of this Agreement, a Supply Agreement or a Quality Agreement, on the one hand, and the RACI Documents, on the other hand, the terms of this Agreement, such Supply Agreement or such Quality Agreement shall prevail. Additionally, [*] shall be [*] responsible for the development of any Clinical Trials or other activities directed to Lifecycle Management for the Licensed Products as agreed Amgen Ref. No. 2015641252 Page 28 Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission. by the JSC and approved by the JMC. [*] shall be responsible at its expense for determining and providing all Medical Affairs Activities relating to the Licensed Products in the Territory.
Responsibility for Development. ILDONG shall have the sole right and responsibility for, and shall have full control and authority over, at its sole cost and expense (including without limitation all costs attributable to the supply of Product for the conduct of Clinical Trials), the Development of Products in the Territory, including conducting all Development activities (including bridging study(ies), if such study(ies) are necessary due to regulatory gaps) beyond the Development activities being conducted by the SUBLICENSOR outside of the Territory (which should be supportive of obtaining Marketing Authorization by the FDA and/or EMA, but may or may not be sufficient to support the obtaining of Marketing Authorization in the Territory) and establishing the methods and means by which it performs such activities under this Agreement. Should ILDONG, for any regulatory filing, desire to utilize data from any clinical trials or studies conducted in indications outside *, *, *, and *, which have been fully funded by the SUBLICENSOR, ILDONG shall pay to the SUBLICENSOR *% of the full cost of the trial which produced such data. ILDONG shall have the right to engage Third Party contractors to perform any of its Development activities in the Territory, provided such Third Party contractors are approved by SUBLICENSOR, such approval not to be unreasonably withheld, and subject to the execution by each such Third Party contractor of an agreement containing provisions that are consistent with and comparable in scope to, Articles 7 and 8 of this Agreement. * Confidential material redacted and filed separately with the Commission.
Responsibility for Development. Unless otherwise expressly agreed by the parties in writing, Client will be solely responsible for all Development and distribution of Client Applications, including all related costs, expenses, losses and liabilities.
Responsibility for Development. Clementia shall have the sole right and responsibility, at its sole cost and expense, for the conduct of all Development activities applicable to any Exclusive Licensed Compound and/or any Licensed Product for use in the Clementia Field and in the Territory, including the Development of any Exclusive Licensed Compound or Licensed Product and the Manufacture of any Exclusive Licensed Compound or Licensed Product as required for the Development and registration of any Licensed Products pursuant to this Agreement. Clementia shall at any times use the Licensed Compounds and Galderma Material solely for the Development and the Manufacture of Licensed Products, and in compliance with Applicable Laws and governmental regulations and guidelines of each country where the Exclusive Licensed Compounds and Galderma Material are used. Clementia shall comply with applicable current GLP, current GCP and current GMP as required by governmental authorities and shall make all facilities, books and records relating to the Exclusive Licensed Compounds and Galderma Material available to audit by Regulatory Authorities for regulatory purposes as required by Applicable Laws. Clementia shall be responsible for the proper and safe handling, storage and use of the Exclusive Licensed Compounds and Galderma Material, by Clementia, its Affiliates or Third Parties, in accordance with Applicable Laws and governmental regulations and guidelines of each country where the Exclusive Licensed Compounds and Galderma Material are used.
Responsibility for Development. Other than with respect to Development related to the Junshi Clinical Trials in accordance with this Article 4 (Development) and Article 3 (Governance), or as otherwise set forth under a Joint Development Plan approved by the JDC, each Party will be solely responsible for Development activities with respect to the Licensed Antibodies and Licensed Products for its respective territory.
Responsibility for Development. MSD shall have responsibility for the development of Collaboration Compounds and Products within the scope of the rights granted to it hereunder. MSD shall use Commercially Reasonable Efforts to develop and commercialize Collaboration Compounds for each therapeutic Indication which is scientifically and commercially reasonable, which shall include Pain and urinary incontinence if such Indications are scientifically and commercially reasonable. NEUROGEN FTEs. Upon the mutual written agreement of both Parties, NEUROGEN may make available FTEs to assist MSD in any development activities conducted pursuant to this Agreement. If MSD elects to utilize NEUROGEN FTEs in development activities, then MSD agrees to fund such FTE participation, quarterly in advance, at the Annual FTE Rate, and shall reimburse NEUROGEN for any external costs incurred by NEUROGEN in the performance of activities conducted pursuant to the Development Plan and upon receipt of an invoice from NEUROGEN; provided, that MSD has approved such costs in writing in advance of NEUROGEN incurring such external costs. Development Plan. As soon as practicable following selection of a Collaboration Compound for preclinical development by MSD, MSD shall, in accordance with its regular business practices, develop a reasonably detailed master development plan, which shall be attached hereto as Attachment 4.2 (as amended by MSD from time to time, the "Development Plan"). MSD shall have the right to amend the Development Plan so long as MSD uses Commercially Reasonable Efforts in making such amendment. MSD shall promptly provide NEUROGEN with a copy of any such amended Development Plan. MSD shall prepare and include in the Development Plan a summary clinical development plan for significant Indications, as applicable, suitable to produce a global registration package. MSD shall conduct, at its sole expense, and as appropriate, activities relating to the formulation, process and clinical development of the Product and obtaining Regulatory Approvals in accordance with the Development Plan, including, as appropriate, activities relating to preclinical testing, clinical studies, manufacturing processes, formulation, quality assurance, quality control, packaging and regulatory affairs in the Territory. Clinical Studies. Using Commercially Reasonable Efforts, MSD shall conduct the pre-clinical and clinical studies, at its own cost and expense, necessary for Regulatory Approval of the Products in the Territory (i...
