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, PROSENSA owns all regulatory filings and Regulatory Approvals (including, orphan drug designations) with respect to PRO051. As soon as reasonably practical after the Effective Date, PROSENSA will transfer and assign ownership of all such regulatory filings and approvals 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, at which time GSK shall own and be fully responsible for all such filings and approvals, including any resulting Market Exclusivity Rights, at its own expense. (ii) Prior to exercise by GSK of its Option over any PROSENSA Collaboration Program, PROSENSA shall own all regulatory filings and Regulatory Approvals (including orphan drug designations) for Compounds. Upon GSK exercising its Option with respect to a PROSENSA Collaboration Program, PROSENSA shall provide notice in writing to GSK of all such regulatory filings and approvals as soon as reasonably practicable for the resulting GSK Development Compounds (including the Secondary Compound), including all relevant INDs, if any, and provide GSK with copies of such INDs and other regulatory filings and approvals 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, 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. 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 Compounds.

Ownership and Transfer of Regulatory Filings and Regulatory Authorizations. (i) The Parties acknowledge that, to the extent existing as of the Effective Date, PROSENSA TELETHON-HSR owns all regulatory filings and Regulatory Approvals (including, orphan drug designations) with respect to PRO051Products included under the ADA-SCID Program. As soon as reasonably practical after the Effective Date, PROSENSA 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/assignmentsassignments 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 PROSENSA Collaboration Program, PROSENSA TELETHON-HSR shall own all regulatory filings and Regulatory Approvals (including orphan drug designations) for CompoundsProducts. Upon GSK exercising its Option with respect to a PROSENSA Collaboration Program, PROSENSA 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 Compounds (including the Secondary Compound)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, PROSENSA 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/assignmentsassignments 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 Compounds.Vectors and Products throughout the Territory. An example of the documents and materials to be transferred to GSK is described in Exhibit B.