definiens: means, in whatever media, any and all books and records, reports and accounts in connection with or relative to the Atrix Manufacturing Costs, Development Costs, Bulk Drug, Raw Materials and Components, Products, and the Professional Samples, any costs [COMPANY] or Atrix is obligated to reimburse or pay to the other Party under this Agreement, Manufacturing ( including without limitation, yield reports and batch records ), Testing, Shipment, delivery or handling of the Bulk Drug, Raw Materials and Components, the Professional Samples and/or the Product, production and quality control records, any pre - clinical or clinical studies, as approved by the JDMC or as required by the Competent Authorities as Phase IV commitments [ ( excluding, however, any clinical studies related to any MSL Single Center Studies but including any clinical studies related to any MSL Multi - Center Studies ), ( * including any and all books, records, reports, research notes, charts, graphs, comments, computations, analyses, recordings, photographs, computer programs and documentation thereof, and other graphic or written data generated in connection with the Development Program [ and MSL Multi - Center Studies ' ( * as well as any other books and records as may be required from time to time by Applicable Laws or this Agreement . Books and Records shall not include any market research and competitive reports, marketing reports and data