definiens: shall mean all ( a ) information, tech niques, technology, practices, trade secrets, inventions ( whether patentable or not ), methods, kn owledge, skill, experience, data, results ( including pharmacological, toxicological and clini cal test data and results, chemical structures, sequences, processes, formulae, techniques, researc h data, reports, standard operating procedures and batch records ), analytical and quality control data, analytical methods ( including applicable reference standards ), full batch documentation, pac kaging records, release, stability, storage and shelf - life data, and manufacturing process informat ion, results or descriptions, software and algorithms of each of the Institutions ; and ( b ) tan gible manifestations thereof . As used in this Agreement, shall include all i nformation related to clinical or non - clinical testing, including patient report forms, investigat ors ’ reports, biostatistical, pharmaco - economic and other related analyses, regulatory filings and communications, de - identified of any individually identifiable health information, inclu ding any data that contains one or more of the identifiers listed in § 164.514(b)(2 ) and in complia nce with any federal and state privacy laws, including the Health Insurance Portability and Acco untability Act of 1996, as amended ( ) . The Parties understand and agree that th is Agreement will not include any patient data for commercial use which has not been de -identified as contemplated above