definiens: means ( i ) all regulatory files relating thereto, including any licenses ( to theextent transferable ), and minutes of meetings and telephone conferences with any Regulatory Authorities, validation data, preclinical and clinical studies and tests related to the Product including original data, case report forms, study files relating tothe aforementioned studies and tests, and all audit reports of clinical studies, plus all applications ( and amendments thereto ) forRegulatory Approvals, annual reports and safety reports associated therewith, drug master files, which are in [COMPANY] ’s or itsAffiliates ’ possession or Control, and all correspondence with Regulatory Authorities regarding the marketing status of theProduct ; and ( ii ) all records maintained under cGMPs or other record keeping or reporting requirements of RegulatoryAuthorities in the Territory, including all correspondence and communications with Regulatory Authorities in connection withthe Product ( including any advertising and promotion documents ), adverse event files, complaint files, manufacturing records