Common use of Development and Commercialization Responsibilities Clause in Contracts

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, Sorrento 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 Sorrento 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 contained herein shall prevent or otherwise restrict Sorrento or any of its Affiliates, in connection with the Reserved CD19 Products, from seeking and obtaining Regulatory Approval of Reserved CD19 Products, and as between Celularity and Sorrento, Sorrento shall own all Regulatory Materials submitted by Sorrento or any of its Affiliates to the Regulatory Authorities and all Regulatory Approvals resulting from such submissions.

Appears in 1 contract

Sources: License and Transfer Agreement (GX Acquisition Corp.)

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, Sorrento 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 Sorrento 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 contained herein shall prevent or otherwise restrict Sorrento TNK or any of its AffiliatesSorrento, in connection with the Reserved CD19 ProductsCD38 Rights, from seeking and obtaining Regulatory Approval of Reserved CD19 CD38 Products, and as between Celularity Celularity, on the one hand, and TNK and Sorrento, Sorrento on the other hand, TNK shall own all Regulatory Materials submitted by TNK or Sorrento or any of its Affiliates to the Regulatory Authorities and all Regulatory Approvals resulting from such submissions.

Appears in 1 contract

Sources: License and Transfer Agreement (Sorrento Therapeutics, Inc.)