definiens: means technical and other information which is not in the public domain, including information anddata comprising or relating to ( i ) non - clinical data including pharmacological, toxicological and metabolic data andresults of all non - clinical studies relevant to the product ; and ( ii ) clinical safety and efficacy data including dataanalyses, study reports and information contained in protocols, filings or other submissions to and responses fromethical committees and Regulatory Authorities ; and ( iii ) pharmacovigilance data ; ( items ( i ) ( ii ) and ( iii ) together being ) and ( iv ) production facilities and processes including any drug master file, specifications, techniques, manufacturing line procedures, chemistry and manufacturing control ( ) data, standard operatingprocedures ( ) quality analysis ( ) and quality control ( ) processes and techniques, and all otherdocumentation retained to comply with GMP procedures ; and ( v ) information relating to contract manufacturers andthe manufacturing 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 ) includes and covers any legal rights 9EXECUTION DRAFT including trade secrets, copyright, database or design rights protecting such Know How . The fact that an item isknown to the public shall not be taken to preclude the possibility that a compilation including the item, and/or adevelopment relating to the item, is not known to the public