definiens: means ( i ) all regulatory files relating thereto, including, but not limited to, any licenses ( to the extent transferable ), and minutes of meetings and telephone conferences with the FDA, validation dat a, preclinical and clinical studies and tests related to the Product including original data, case report forms, study files relating to the aforementioned studies and tests, and all audit reports of clinical studies, plus all investigational new drug appl ications and amendments, annual reports and safety reports associated therewith, drug master files, as well as any foreign equivalents of any of the foregoing, which are in [COMPANY] 's or its Affiliates ' possession or control, and all correspondence with the FDA regarding the marketing status of the Product ; and ( ii ) all records maintained under current Good Manufacturing Practices ( ) or other record keeping or reporting requirements of the FDA, the Environmental Protection Agency, the Occupational Safe ty and Health Administration or any other United States or foreign regulatory authorities, including, but not limited to, FDA warning letters, FDA Notices of Adverse Finding Letters, FDA audit reports ( including any comments on such reports ), all other cor respondence and communications with regulatory agencies in connection with the Product ( including any advertising and promotion documents and 2253 forms ), adverse event files, complaint files, manufacturing records ; as well as any foreign equivalents of an y of the foregoing which are in [COMPANY] 's or its Affiliates ' possession or Control