definiens: means the following information an d materials ( including samples and other tangible embodiments ): ( i ) all in formation concerning the Product formulation and the process by which the Pr oduct formulation is made ( including materials ) ; ( ii ) all technology, in formation, data, regulatory documentation, materials and know - how re lated to the 3 [ * CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO C ERTAIN PORTIONS OF THIS DOCUMENT . EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [ * * * ], HAS BEEN FILED SEPARATELY W ITH THE SECURITIES AND EXCHANGE COMMISSION . ] development, formulation, Manufacturing, packaging, use, testing or Regulatory Approval of the Product, including ( but not limited to ), trade secrets, designs, research and development, results, methods, techniques, derivations, processes, formulations, dosage forms, concepts, ideas, preclinical, clinical, biological, chemical, pharma cological, toxicological, pharmaceutical or other data, valida tion information, adverse effects or experiences, plans, stability hi story, testing methods, experimental methods, specifications, assays, in vi tro data, in vivo data, material and Product supplier information, test met hods for raw materials, components, work - in - process and finished product, s tability test methods, descriptions, expert opinions and analyses, ideas, depictions, discoveries, modifications, improvements and extensions, medical support information ( including data bases ), and market studies ; ( iii ) a ll clinical and other studies performed with respect to the Product and t he results of any other Product testing conducted, including all related cl inical files, data and analyses ; ( iv ) all correspondence to and from the F DA, minutes of meetings with the FDA, and all memoranda, notes, information, filings and documentation relating to obtaining FDA or other Re gulatory Approval for the Product ; and ( v ) all other written, printed or electronically stored information and tangible materials, including combi nations, summaries and compilations of the foregoing, related to the devel opment, Manufacturing, testing, import, export, use, marketing, sale, dist ribution or Regulatory Approval of the Product