definiens: means all data and information owned orcontrolled by either Party relating to ( i ) the pharmacological or toxicological properties ofany Product, ( ii ) any pre - clinical or clinical testing and experience in relation to anyProduct and ( iii ) the chemical composition, manufacturing processes and quality controltesting of any Product, to the extent reasonably required for purposes of any applicationfor Marketing Authorization . Supporting Data shall also include copies of annual reports, integrated study reports, protocols for clinical research and pre - clinical studies, protocolchanges and amendments, safety data, contract research organization databases, casereport forms and access to patient records, toxicity, safety and metabolism reports anddata, and pharmacokinetic data and reports owned or controlled by DOY or a sublicenseeofDOY and relating to any Product that would be useful for a person pursuing clinicalresearch and regulatory approval, or that would typically be part of any submission to a4Regulatory Authority for the purpose of obtaining approval ofa Product for theindication in question