definiens: means, in respect of the Product, ( a ) the trial master file and all regulatory filesrelating to the Development, Regulatory Approval, Manufacture or Commercialization of the product, minutes ofmeetings and telephone conferences with any Regulatory Authorities, validation data, preclinical and clinicalstudies and tests related to the product ( including all audit reports of clinical studies and all other clinical data ), allapplications ( and amendments thereto ) for Regulatory Approvals, annual reports and safety reports associatedtherewith, and all correspondence with Regulatory Authorities regarding the marketing status of the product ; and(b ) all records maintained under Current Good Manufacturing Practices or other applicable Laws, including recordkeeping or reporting requirements of Regulatory Authorities, all correspondence and communications withRegulatory Authorities in connection with the product, including those relating to any Product Labeling orPromotional Materials, adverse event files, complaint files or manufacturing records