definiens: means any : ( a ) scientific or technical information, 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 secrets, devices, databases, practices, protocols, regulatory filings, methods, processes ( includ ing manufacturing processes, specification and techniques ), techniques, concepts, ideas, specifications, formulations, formulae, data ( including pharmacological, biological, chemical, toxicological, clinical and analytical information, quality control, tri al and stability data ), case report forms, medical records, data analyses, reports, studies and procedures, designs for experiments and tests and results of experimentation and testing ( including results of research or development ), summaries and inform ation contained in submissions to and information from ethical committees, or Regulatory Authorities, and manufacturing process and development information, results and data, whether or not patentable, all to the extent not claimed or disclosed in a patent or patent application ; and ( b ) compositions of matter, cells, cell lines, assays, animal models and physical, biological or chemical material, including drug substance samples, intermediates of drug substance samples, drug product samples and intermediate s of drug product samples . “ Know -How ’’ includes any rights including copyright, database or design rights protecting such Know -How . excludes Patent Rights