definiens: means technical and other information which is not in the public domain, including information and datacomprising or relating to ( i ) non - clinical data including pharmacological, toxicological and metabolic data and results of allnon - clinical studies relevant to the product ; and ( ii ) clinical safety and efficacy data including data analyses, study reportsand information contained in protocols, filings or other submissions to and responses from ethical committees andRegulatory Authorities ; and ( iii ) safety ( pharmacovigilance ) data ; and ( iv ) production facilities and processes including anydrug master file, specifications, techniques, manufacturing line procedures, chemistry and manufacturing control data, standard operating procedures quality assurance and quality control processes and techniques, and all otherdocumentation retained to comply with GMP procedures ; and ( v ) information relating to contract manufacturers and themanufacturing supply chain of the Product, including API, fill finish, primary and secondary packaging ( items ( iv ) and ( v)together being ) . Know How includes ( a ) Documents containing Know How ; and ( b ) includesand covers any legal rights including trade secrets, copyright, database or design rights protecting such Know How . Thefact that an item is known to the public shall not be taken to preclude the possibility that a compilation including the item, and/or a development relating to the item, is not known to the public