Common use of Transfer of Regulatory Materials Clause in Contracts

Transfer of Regulatory Materials. At Summit’s option, Sarepta shall as promptly as practicable transfer to Summit or Summit’s designee (i) possession and ownership of all governmental or regulatory correspondence, conversation logs, filings and approvals (including all Regulatory Approvals and pricing and reimbursement approvals) relating to the Development, Manufacture or Commercialization of the applicable Terminated Licensed Product(s) in the applicable Terminated Country(ies), (ii) copies of all data, reports, records and materials and other sales and marketing related information in Sarepta’s possession or Control to the extent that such data, reports, records, materials or other information relate to the Development, Manufacture or Commercialization of the applicable Terminated Licensed Product(s) in the applicable Terminated Country(ies), including all non-clinical and clinical data relating to the applicable Terminated Licensed Product(s), and customer lists and customer contact information and all adverse event data in Sarepta’s possession or Control relating to the applicable Terminated Licensed Product(s); provided that Sarepta shall use Commercially Reasonable Efforts to obtain for Summit the right to access all such data, reports, records, materials and other sales and marketing related information and (iii) all records and materials in Sarepta’s possession or Control containing Confidential Information of Summit relating to the applicable Terminated Licensed Product(s) in the applicable Terminated Country(ies). Sarepta shall further appoint Summit as Sarepta’s or Sarepta’s Related Parties’ agent for all applicable Terminated Licensed Product(s)-related matters involving Regulatory Authorities in the Sarepta Territory (or the in the applicable Terminated Country(ies), if applicable) until all applicable Regulatory Approvals and other regulatory filings have been transferred to Summit or its designee.

Appears in 2 contracts

Sources: License and Collaboration Agreement (Sarepta Therapeutics, Inc.), License and Collaboration Agreement (Summit Therapeutics PLC)