Common use of Ownership and Transfer of Regulatory Filings and Regulatory Authorizations Clause in Contracts

Ownership and Transfer of Regulatory Filings and Regulatory Authorizations. (i) The Parties acknowledge that, to the extent existing as of the Effective Date, TELETHON-HSR owns all regulatory filings and Regulatory Approvals (including, orphan drug designations) with respect to Products included under the ADA-SCID Program. As soon as reasonably practical after the Effective Date, TELETHON-HSR will transfer and assign ownership of all such regulatory filings and approvals throughout the Territory to GSK (or its designated Affiliate), and send any correspondence to regulatory authorities, execute any instruments, or take any other steps GSK reasonably deems necessary to effectuate such transfers/assignments to GSK (or its designated Affiliate) throughout the Territory, at which time GSK shall own and be fully responsible for all such regulatory filings and approvals, including any resulting Market Exclusivity Rights, at its own expense, throughout the Territory. An example of the documents and materials to be transferred to GSK is described in Exhibit B. (ii) Prior to exercise by GSK of its Option over any Collaboration Program, TELETHON-HSR shall own all regulatory filings and Regulatory Approvals (including orphan drug designations) for Products. Upon GSK exercising its Option with respect to a Collaboration Program, TELETHON-HSR shall provide notice in writing to GSK of all such regulatory filings and approvals in the Territory as soon as reasonably practicable for the resulting GSK Development Vectors and Products, including all relevant INDs, if any, and provide GSK with copies of such INDs and other regulatory filings and approvals in the Territory and all pre-clinical and clinical data and results (including pharmacology, toxicology, formulation, and stability studies). Upon exercise of such Option, as soon as reasonably practical thereafter, TELETHON-HSR shall assign and transfer to GSK (or its designated Affiliate), and send any correspondence to Regulatory Authorities, execute any instruments, or take any other steps GSK reasonably deems necessary to effectuate such transfers/assignments to GSK or its designated Affiliate throughout the Territory. GSK (or its designated Affiliate) shall thereafter own and be fully responsible for maintaining all regulatory filings and Regulatory Approvals (including orphan drug designations) and any resulting Market Exclusivity Rights for GSK Development Vectors and Products throughout the Territory. An example of the documents and materials to be transferred to GSK is described in Exhibit B.

Ownership and Transfer of Regulatory Filings and Regulatory Authorizations. (i) The Parties acknowledge that, to the extent existing as of the Effective Date, TELETHON-HSR PROSENSA owns all regulatory filings and Regulatory Approvals (including, orphan drug designations) with respect to Products included under the ADA-SCID ProgramPRO051. As soon as reasonably practical after the Effective Date, TELETHON-HSR PROSENSA will transfer and assign ownership of all such regulatory filings and approvals throughout the Territory to GSK (or its designated Affiliate), and send any correspondence to regulatory authorities, execute any instruments, or take any other steps GSK reasonably deems necessary to effectuate such transfers/assignments to GSK (or its designated Affiliate) throughout the Territoryassignments, at which time GSK shall own and be fully responsible for all such regulatory filings and approvals, including any resulting Market Exclusivity Rights, at its own expense, throughout the Territory. An example of the documents and materials to be transferred to GSK is described in Exhibit B.. (ii) Prior to exercise by GSK of its Option over any PROSENSA Collaboration Program, TELETHON-HSR PROSENSA shall own all regulatory filings and Regulatory Approvals (including orphan drug designations) for ProductsCompounds. Upon GSK exercising its Option with respect to a PROSENSA Collaboration Program, TELETHON-HSR PROSENSA shall provide notice in writing to GSK of all such regulatory filings and approvals in the Territory as soon as reasonably practicable for the resulting GSK Development Vectors and ProductsCompounds (including the Secondary Compound), including all relevant INDs, if any, and provide GSK with copies of such INDs and other regulatory filings and approvals in the Territory and all pre-clinical and clinical data and results (including pharmacology, toxicology, formulation, and stability studies). Upon exercise of such Option, as soon as reasonably practical thereafter, TELETHON-HSR PROSENSA shall assign and transfer to GSK (or its designated Affiliate), and send any correspondence to Regulatory Authorities, execute any instruments, or take any other steps GSK reasonably deems necessary to effectuate such transfers/assignments to GSK or its designated Affiliate throughout the Territoryassignments. GSK (or its designated Affiliate) shall thereafter own and be fully responsible for maintaining all regulatory filings and Regulatory Approvals (including orphan drug designations) and any resulting Market Exclusivity Rights for GSK Development Vectors and Products throughout the Territory. An example of the documents and materials to be transferred to GSK is described in Exhibit B.Compounds.