definiens: means ( a ) all regulatory filings and supporting documents ( including copies of all correspondence between any of Sellers and their Controlled Affiliates and the applicable Regulatory Authority ), chemistry, manufacturing and con trols data and documentation, preclinical and clinical studies and tests, ( b ) the ANDA and all regulatory files and foreign equivalents related thereto, current approved packaging and any other existing files and dossiers, including the underlying data or information used to support, maintain or obtain marketing authorization of the underlying Product, ( c ) all records maintained under record keeping or reporting Laws of the FDA or any other Governmental Authority including all applications, annual and safet y reports, drug master files, FDA warning letters, FDA notices of adverse finding letters, FDA audit reports ( including any responses to such reports ), any correspondence with the Office of Prescription Drug Promotion, periodic safety update reports, compl ai nt files, and annual product quality reviews, ( d ) the complete complaint, adverse event and medical inquiry filings with respect to the Products as required by applicable Laws and Related to the Business, including the Regulatory Registrations and ( e ) al l equivalent, comparable or analogous documentation with respect to any other country outside the United States