definiens: means ( i ) all regulatory files relating thereto, including anylicenses ( to the extent transferable ), and minutes of meetings and telephone conferences with any RegulatoryAuthorities, validation data, preclinical and clinical studies and tests related to the Product including originaldata, case report forms, study files relating to the aforementioned studies and tests, and all audit reports ofclinical studies, plus all applications ( and amendments thereto ) for Regulatory Approvals, annual reports andsafety reports associated therewith, drug master files, which are in Seller ’s or its Affiliates ’ possession orControl, and all correspondence with Regulatory Authorities regarding the marketing status of the Product;and ( ii ) all records maintained under cGMPs or other record keeping or reporting requirements ofRegulatory Authorities in the Territory, including all correspondence and communications with RegulatoryAuthorities in connection with the Product ( including any advertising and promotion documents ), adverseevent files, complaint files, manufacturing records . shall mean the [COMPANY] Patents and [COMPANY] Know How