definiens: shall mean all applications, registrations, license s, authorizations and approvals ( including all Regulatory Approvals ), all correspondence submitted to or received from Regul atory Authorities ( including minutes and official contact reports relating to any communications with any Re gulatory Authority ) and all supporting documents in connecti on therewith, and all non - clinical and clinical stu dies and tests ( including any Regulatory Clinical Studies and Non- Regulatory Clinical Studies ), relating to the use o f the Product for Agreed Indications in the Field, or as required for regulatory purposes and all Data contained in any of the foregoing, including all INDs, IMPDs, MAA ’s, regula tory drug lists, advertising and promotion document s, manufacturing data, drug master files, Clinical Dat a, adverse event files and complaint files, in each case related to the Product and Agreed Indications in the Field, or as required for regulatory purposes