definiens: means all applications, registrations, licenses, authorizations andapprovals, all correspondence submitted to or received from Regulatory Authorities ( including minutes and official contactreports relating to any communications with any Regulatory Authority ), and all supporting documents and all clinical studiesand tests, in each case, relating to Exclusive Products or Licensed Products, and all data contained in any of the foregoing, including all 12 Execution CopyCertain portions of this Exhibit have been omitted pursuant to a request for confidentiality . Such omittedportions, which are marked with brackets [ ] and an asterisk *, have been separately filed with the Commission INDs, Drug Approval Applications, Regulatory Approvals, regulatory drug lists, marketing and promotion documents, ProductData, adverse event files and complaint files, Manufacturing records ( including any CMC Data ), submission logs, Orphan Productdesignations and any related documentation that are ( i ) with respect to any such documents and data relating to LicensedProducts that are not Exclusive Products, Controlled by [COMPANY] and its Affiliates as of the Effective Date or during theTransition Period, and ( ii ) with respect to any such documents and data relating to Exclusive Products, Controlled by Medtronicand its Affiliates as of the Effective Date or during the Term