definiens: means confidential and proprietary information and tangible materials, whether patentable or unpatentable, within the Control of : ( i ) with respect to [COMPANY] Sankyo, [COMPANY] Sankyo ; or ( ii ) with respect to [COMPANY], [COMPANY] ; in either case that is necessary or useful for the development or commercialization of the API or Product and that exists as of the Effective Date or is discovered, developed or acquired during the Term, including, without limitation : ( i ) ideas, discoveries, Inventions, improvements or trade secrets, ( ii ) tests, assays, techniques, methods, procedures, formulas, processes and data, including, but not limited to, clinical data ( including patient report forms, investigators ' reports ( both preliminary and final ), statistical analyses, expert opinions and reports, safety and other electronic databases, Regulatory Filings and communications, and the like ), pharmacological, preclinical and toxicological data, as well as manufacturing information and descriptions, with respect to the API or Product, and ( iii ) pharmaceutical, chemical and biological materials, products and compositions of matter in each case that are reasonably necessary or useful for the research, development, manufacture and commercialization of the API or Product III accordance with this Agreement . Know - How shall not include any Patents