definiens: means the files ( including all electronic data files),documents, correspondence, lists, drawings and specifications, creativematerials, marketing plans, studies, reports, and other printed or writtenmaterials of the Business ( in whatever form or medium ), including, withoutlimitation, ( i ) all clinical or pre - clinical scientific studies and datarelating to the Products, ( ii ) all files and data packages that are part of eachIND and NDA and all correspondence with any Governmental Entity related to eachIND and NDA ( including information on clinical and pre - clinical studies andadverse event reports ), ( iii ) all correspondence with any Governmental Entityrelated to the use of the Products ( including any information on clinical andpre - clinical studies, adverse events, written contact regulatory reports andformal minutes with any Governmental Entity to the extent Seller normallyretains such records and minutes in the ordinary course of its regulatoryactivities ), ( iv ) any and all rights of reference to any files ( including anydrug master files ) cited in each IND and NDA, ( v ) all other documents relatingto each IND and NDA or to the subject matter of each IND and NDA and ( vi ) allfinancial books, records, statements or reports of Seller to the extent suchitems relate to the Acquired Assets