definiens: means any scientific or technical information, re sults and data of any type whatsoever, in any tangible or intangible form what soever, that is not in the public domain, including, without limitation, discoveries, inventions, trade secrets, databases, practices, protocols, regulatory filing s, methods, processes, techniques, software, works of authorshi p, plans, concepts, ideas, biological and other mat erials, reagents, specifications, formulations, formulae, c ase reports forms, data analyses, reports, studies and procedures, designs for experiments and tests and results of ex perimentation and testing ( including results of res earch or development ), summaries and information contained i n submissions to and information from ethical commi ttees, the FDA or other Regulatory Authorities, manufactur ing process and Development information, results an d data, specifications, instructions, materials, expertise and other technology applicable to compounds, formu lations, compositions or products or to their manufacture, D evelopment, registration, use or Commercialization or methods of assaying or testing them or processes for their manufacture, formulations containing them, composit ions incorporating or comprising them and including all biological, chemical, pharmacological, biochemical, toxicological, pharmaceutical, physical and analyti cal, safety, stability, quality control, manufactur ing, preclinical and clinical data, expertise and information, regul atory filings and copies thereof, including without limitation those that relate to or are directed to Captisol or its manufacture and/or use . Notwithstanding the fo regoing, the defined term Know - How ( and derivative defined terms thereof ) shall not include Licensor Patents or inv entions claimed thereby, nor any portion of the DMF not wit hin the definition of Captisol Data Package