definiens: shall mean any and all ( i ) regulatoryfilings, including investigational drug applications ( ), new drugapplications ( ) and abbreviated new drug applications ( ) together with and supporting documents, clinical studies and tests, includingany such filings, Permits, documents, studies and tests related to the Productsand any improvements thereto, and ( ii ) records maintained under GoodManufacturing Practices ( ) or other record keeping or reportingrequirements of the FDA, the Environmental Protection Agency, the OccupationalHealth and Safety Administration, the Nuclear Regulatory Commission or anyother United States or foreign regulatory authorities, including allinvestigational new drug applications, new drug applications, abbreviated newdrug applications, ( including any application withdrawals or expectedwithdrawals of any of the foregoing ), drug master files, FDA approvals forexport, FDA warning letters, FDA Notice of Adverse Finding letters, FDA auditreports ( including any comments on such reports ), other correspondence withregulatory agencies ( registrations and licenses, regulatory drug lists, advertising and promotion documents ), adverse event files, IND safety reports, complaint files and manufacturing records ( as well as any foreign equivalentsof the foregoing ), with respect thereto