definiens: means ( a ) all regulatory filings and supporting documents ( including copies ofall correspondence between Seller Parent or any of its Subsidiaries and the applicable Regulatory Authority),chemistry, manufacturing and controls data and documentation, and preclinical and clinical studies and tests, ( b ) allregulatory files and foreign equivalents related thereto, current approved packaging and any other existing files anddossiers, including the underlying data or information used to support, maintain or obtain marketing authorization ofthe underlying Product, ( c ) all records maintained under record keeping or reporting Laws of the FDA or any otherGovernmental Authority including all applications, annual and safety reports, drug master files, FDA warning letters, FDA notices of -18 - adverse finding letters, FDA audit reports ( including Establishment Inspection Reports ( EIR ) and any responses tosuch reports ), any correspondence with the Office of Prescription Drug Promotion, periodic safety update reports, complaint files, and annual product quality reviews, ( d ) the complete complaint, adverse event and medical inquiryfilings with respect to the Products as required by applicable Laws, including the Regulatory Registrations and ( e ) allequivalent, comparable or analogous documentation with respect to any other country outside the United States