definiens: means ( a ) all regulatory filings and supporting d ocuments ( including copies of all correspondence between any of Sellers and their Controlled Affiliates and the applicable Regulatory Authority ), chemistry, manufacturing and controls d ata and documentation, preclinical and clinical stu dies and tests, ( b ) the ANDA and all regulatory files and fo reign equivalents related thereto, current approved packaging and any other existing files and dossiers, includin g the underlying data or information used to suppor t, maintain or obtain marketing authorization of the underlying Product, ( c ) all records maintained under record k eeping or reporting Laws of the FDA or any other Governmental Authority including all applications, annual and s afety reports, drug master files, FDA warning letters, FD A notices of adverse finding letters, FDA audit rep orts ( including any responses to such reports ), any corr espondence with the Office of Prescription Drug Pro motion, periodic safety update reports, complaint files, an d annual product quality reviews, ( d ) the complete complaint, adverse event and medical inquiry filings with resp ect to the Products as required by applicable Laws and Related to the Business, including the Regulatory Registrat ions and ( e ) all equivalent, comparable or analogou s documentation with respect to any other country out side the United States