definiens: shall mean all data and informati on relating to ( a ) the pharmacological or toxicological properties of the Products, ( b ) any p re - clinical or clinical testing and experience in relation to the Products and ( c ) the chemical composition, s ynthesis, formulation, compounding, and Manufacturing and quality control testing of the Pr oducts, to the extent reasonably required for purpo ses of any application for Marketing Authorization for the Products . Supporting Data shall also include, b ut is not limited to, copies of annual reports, integr ated study reports, protocols for clinical research and pre - clinical studies, protocol changes and amendmen ts, Chemistry, Manufacturing and Control ( ) sections and amendments, safety data, clini cal databases, case report forms and access to patient records, toxicity, safety and metabolism re ports and data, and pharmacokinetic data and report s and relating to the Products, as well as, in general, data or information * Denotes confidential information that has been omit ted from the exhibit and filed separately, accompan ied by a confidential treatment request, with the Secur ities and Exchange Commission pursuant to Rule 24b- 2 of the Securities Exchange Act of 1934