definiens: means any : ( a ) scientific or technical informatio n, results and data of any type whatsoever, in any tangible or intangible form whatsoever, that is not in the public domain or otherwise publicly known, including discoveries, inventions, trade sec rets, devices, databases, practices, protocols, reg ulatory filings, methods, processes ( including manufacturin g processes, specification and techniques ), techniq ues, concepts, ideas, specifications, formulations, form ulae, data ( including pharmacological, biological, chemical, toxicological, clinical and analytical in formation, quality control, trial and stability dat a ), case reports forms, medical records, data analyses, repo rts, studies and procedures, designs for experiment s and tests and results of experimentation and testing ( i ncluding results of research or development ), summa ries and information contained in submissions to and inf ormation from ethical committees, or Regulatory Authorities, and manufacturing process and developm ent information, results and data, whether or not patentable, all to the extent not claimed or disclo sed in a patent or patent application ; and ( b ) comp ositions of matter, assays, animal models and physical, biol ogical or chemical material, including drug substan ce samples, intermediates of drug substance samples, d rug product samples and intermediates of drug produ ct samples . The fact that an item is known to the publ ic shall not be taken to exclude the possibility th at a compilation including the item, and/or a developmen t relating to the item, is ( and remains ) not known to the public . includes any rights includin g copyright, database or design rights protecting s uch Know -How . excludes Patent Rights