definiens: means all data and information relating to ( i ) the pharmacological or toxicological propertiesof any Product, ( ii ) any pre - clinical or clinical testing and experience in relation to any Product and ( iii ) thechemical composition, synthesis, formulation, compounding, and manufacturing and quality control testing ofany Product, to the extent reasonably required for purposes of any application for Regulatory Approval for aProduct . Supporting Data will also include, but is not limited to, copies of annual reports, integrated studyreports, protocols for clinical research and pre - clinical studies, protocol changes and amendments, Chemistry, Manufacturing and Control ( CMC ) sections and amendments, safety data, clinical databases, case report forms and access to patient records, toxicity, safety and metabolism reports and data, andpharmacokinetic data and reports and relating to any Product, as well as, in general, data or information whichwould typically be part of any submission to FDA or other Regulatory Agency for the purpose of obtainingapproval of any Product for any indication