definiens: means ( i ) all pre -clinical and clinical protocols, studies, data and results and study -related forms, materials and reports ( e.g., investigator brochures, informed consent forms, data safety monitoring board related documents, patient recruitment related materials, biocompatibility studies, animal studies, safety studies, and chemistry, manufacturing and control data ) used in or resulting from any pre -clinical or clinical study or trial and any audits of any pre -clinical or clinical study or trial of any First Generation Exclusive Licensed Product or the Vitrasert Licensed Pr oduct in the Licensed Field, and ( ii ) all INDs, NDAs, any unfiled applications, components or materials normally associated with an IND or NDA, regulatory filings or applications comparable to INDs or NDAs in any foreign jurisdictions, and other r egulatory applications and approvals regarding any First Generation Exclusive Licensed Product or the Vitrasert Licensed Product in the Licensed Field