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 data and documentation, and preclinical a nd clinical studies and tests, ( b ) all regulatory file s 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 u nderlying Product, ( c ) all records maintained under record keeping or reporting Laws of the FDA or any other G overnmental Authority including all applications, a nnual and safety reports, drug master files, FDA warning letters, FDA notices of adverse finding letters, FD A audit reports ( including Establishment Inspection Reports ( EIR ) and any responses to such reports ), any correspondence with the Office of Prescription Drug Promotion, periodic safety update reports, complai nt files, and annual product quality reviews, ( d ) the complet e complaint, adverse event and medical inquiry fili ngs with respect to the Products as required by applicable L aws, including the Regulatory Registrations and ( e ) all equivalent, comparable or analogous documentation w ith respect to any other country outside the United States