definiens: means all ( a ) regulatory filings and supporting documents, chemistry, manufacturing and controls data and documentation ( including, but not limited to, batch records, master batch productionrecords, standard operating procedures, testing logs, sample logs, laboratory logs, and stability logs ) in each case to the extentpertaining to the Products, preclinical and clinical studies and tests for the Products, ( b ) records maintained under record - keeping or reporting requirements of the FDA or any Governmental Body with respect to the Products, ( c ) the completecomplaint, adverse event and medical inquiry filings with respect to the Products, ( d ) all documentation relating to the FDA orany other Governmental Body inspections to the extent pertaining to the Products and any communication with the FDA orany other Governmental Body to the extent pertaining to the Products, including correspondence and written minutes oftelephone calls or meetings, and ( e ) all documentation related to the FDA or any other Governmental Body inspections of thefacilities of ChemWerth USA, King Pharmaceuticals, Sigma Aldrich Corp., American Type Culture Collection, Drug SourceCompany, NucroTechnics, SafeTec, Tetrionics, Hauser, Livingston or any other Entity conducting material activities relatingto the manufacture or sale of the Products, in each of ( a ) through ( e ) only to the extent ( i ) Seller possesses and can legallytransfer such information, and ( ii ) such information exclusively pertains to the Products, and in all events exclusive of ProductRegistrations