Development and Commercialization Responsibilities. Licensee shall have the sole right and responsibility for, and control over, all development, manufacturing and commercialization activities (including all regulatory activities) with respect to Licensed Products and Licensed Services in the Field.
Development and Commercialization Responsibilities. Dicerna shall have the sole right and responsibility for, and control over, all research, development, manufacturing and commercialization activities (including all regulatory activities) with respect to Licensed Products in the Fields.
Development and Commercialization Responsibilities. Otonomy (itself or through its Affiliates or designees) shall pay for all costs related to and shall bear all responsibility for the development, manufacturing, registration and sale of the Licensed Product(s). Otonomy (itself or through its Affiliates or designees) shall pay for all costs related to and shall bear all responsibility for all marketing and promotional activities related to Licensed Product(s) in the Territory and shall decide on the strategy regarding such activities. Otonomy shall use Commercially Reasonable Efforts to develop, obtain Approvals for, promote and sell Licensed Product(s) being granted Approval in the Territory, it being understood that the efforts of Otonomy’s Affiliates and Sublicensees shall count towards Otonomy’s own Commercially Reasonable Efforts.
Development and Commercialization Responsibilities. Except as expressly set forth herein or otherwise agreed upon by the Parties in writing on a case-by-case basis, Celularity or its sublicensee(s) shall be solely responsible for all development, pre-clinical and clinical testing of the Licensed Products and preparation and filing of all Regulatory Materials and any other documents required in connection with seeking and obtaining Regulatory Approval of the Licensed Products, at Celularity’s or its sublicensee’s (as applicable) sole cost and expense. Notwithstanding the foregoing, TNK may provide Celularity with certain assistance in connection with such development and testing activities and obtaining Regulatory Approval, provided that any such services shall be subject to and governed by a separate definitive written services agreement to be executed by TNK and Celularity (“Services Agreement”). As between the Parties, Celularity shall own all Regulatory Materials submitted by Celularity to the Regulatory Authorities and all Regulatory Approvals resulting from such submissions. Following receipt of Regulatory Approval for a Licensed Product, Celularity or its sublicensee(s) will be solely responsible for all sales, marketing and distribution decisions and costs and related commercialization activities related to such Licensed Product. Notwithstanding anything contained herein to the contrary, nothing herein shall prevent or otherwise restrict TNK or Sorrento, in connection with the Reserved CD38 Rights, from seeking and obtaining Regulatory Approval of Reserved CD38 Products, and as between Celularity, on the one hand, and TNK and Sorrento, on the other hand, TNK shall own all Regulatory Materials submitted by TNK or Sorrento to the Regulatory Authorities and all Regulatory Approvals resulting from such submissions.
Development and Commercialization Responsibilities. Subject to Section 3.1, all decisions concerning the Research, Development, Manufacture and Commercialization of the Licensed Product, including the clinical and regulatory strategy of the Licensed Product, the marketing and sales of the Licensed Product, and the design, price, and promotion of the Licensed Product, shall be at the sole discretion of Fulcrum. If Fulcrum reasonably requests assistance or input from CAMP4 with respect to Research or Development activities being undertaken by Fulcrum in respect of a Licensed Product, CAMP4 shall (at Fulcrum’s expense), use its Commercially Reasonable Efforts to cooperate in good faith with Fulcrum in response to such request (e.g., by responding to regulatory inquiries relating to the pre-clinical development of a Licensed Product by CAMP4, intellectual property matters with respect to Licensed Patents and Know-How, etc.).
Development and Commercialization Responsibilities. (a) Sublicensee shall be solely responsible for, and shall bear the entire cost of performing or having performed, all Development of Licensed Compounds and Licensed Products in the Sublicensed Field in the Territory, and all Commercialization of Licensed Products in the Sublicensed Field in the Territory, and the satisfaction of all regulatory requirements with respect thereto. As between the Parties, and subject to the provisions of Article IV. Sublicensee shall assume responsibility for fulfilling the obligations set forth in Article 3 of the Head License for the Sublicensed Field in the Territory.
Development and Commercialization Responsibilities. Subject to paragraph (a), the Licensee will comply with the current Development Plan including all timeframes set out in the Development Plan. Licensee shall have the sole right and control over, all of its development, manufacturing and commercialization activities (including all regulatory activities) with respect to Licensed Products in the Field and in the Territory. Licensee will update the Development Plan and provide a copy of the same to the Licensor at least once every six (6) months. The format of such updated Development Plan shall be no less detailed than, and consistent with the format of, the version annexed at Schedule 1 at the Effective Date, unless agreed otherwise by the Parties.
Development and Commercialization Responsibilities. Subject to this Section 6.7, NeuroSystec shall pay for all costs related to and shall bear all responsibility for the development, manufacturing, registration and sale of the Licensed Product(s). Subject to this Section 6.7, NeuroSystec shall pay for all costs related to and shall bear all responsibility for all marketing and promotional activities related to Licensed Product(s) in the Territory and shall decide on the strategy regarding such activities. NeuroSystec shall use Commercially Reasonable Efforts to develop, obtain Approvals for, promote and sell Licensed Product(s) being granted Approval in the Territory. ***Material has been omitted pursuant to a request for confidential treatment and such material has been filed separately with the SEC.
Development and Commercialization Responsibilities. During the Term, Curis shall have the sole right and responsibility for, and control over, all research, development, manufacturing and commercialization activities, including all regulatory activities, with respect to Licensed Products, at Curis’ sole cost and expense.
Development and Commercialization Responsibilities. (i) During the term of this Agreement, Sorrento shall have sole control over all Licensed Products in the Field in the Territory. As between the Parties, following receipt of Regulatory Approval for a Licensed Product, and subject to ACEA’s obligation to supply Product Materials to Sorrento as provided hereunder or pursuant to one or more Supply Agreements (including CMC and clinical development obligations), and further subject to any other obligations of ACEA under this Agreement or in any Supply Agreement, Sorrento shall be solely responsible, at its own expense, for all aspects of the development (including, but not limited to, chemistry manufacturing controls, and clinical development), manufacture, registration and commercialization (including, but not limited to, marketing, promoting, selling, distributing and determining pricing) of such Licensed Product in the Field in the Territory.
