definiens: means all ( a ) information, techniques, technology, practices, trade secrets, inventions ( whetherpatentable or not ), methods, knowledge, know - how, skill, experience, data, results ( including pharmacological, toxicological and clinical test data and results, and Research or Development data, reports and batch records ), clinical, safety, analytical and quality control data, analytical methods ( including applicable reference standards ), full batchdocumentation, packaging records, release, stability, storage and shelf - life data, manufacturing process informationand quality control data, results or descriptions, software and algorithms, regulatory filings, pharmaceutical data, instructions, processes, procedures, formulas, drawings, technical and non - technical data and ( b ) compositions ofmatter, cells, cell lines, assays, animal models and physical, biological or chemical material . As used in this definition, shall be deemed to include all information related to the clinical or pre - clinical testing of aCompound or Product, including without limitation patient report forms, investigators ’ reports, biostatistical, pharmaco - economic and other related analyses, regulatory filings and communications, and the like