definiens: means, in respect of a Product, ( a ) the trial mas ter file and all regulatory files relating to the development, Regulatory Approval ( i ncluding Regulatory Filings ), manufacture or commercialization of the Product, including any lic enses ( to the extent transferable ), minutes of meet ings and telephone conferences with any Governmental Authori ties ( to the extent maintained in such files ), vali dation data, preclinical and clinical studies and tests re lated to the Product ( including all Clinical Trial Reports, audit reports of clinical studies and all other clinical data, annual reports and safety reports associated therewith, which are in a Seller 's or its Subsidiaries ' control, and all correspondence with Governmental Authorities r egarding the marketing status of the Product ; and ( b ) all record s maintained under Good Manufacturing Practices or other applicable Legal Requirements, including record kee ping or reporting requirements of Governmental Authorities, all correspondence and communications with Governmental Authorities in connection with th e Product, including those relating to any product la beling or promotional materials, adverse event file s, complaint files or manufacturing records