definiens: means any know how that is necessary or useful for the Research, Development, use, manufacture, or Commercialisation of a Product which has as its primary mode ofaction inhibition of FGFR1, FGFR2, FGFR3 and/or FGFR4 and associated biomarkers and/or diagnostictools, including information and data comprising or relating to ( i ) non - clinical data including mode ofaction, biomarker, pharmacological, toxicological and metabolic data and results of all non - clinicalstudies relevant to the Product ; ( ii ) clinical data including data analyses, study reports and informationcontained in protocols, filings or other submissions to and responses from ethical committees andRegulatory Authorities ; ( iii ) safety ( pharmacovigilance ) data ; and ( iv ) data or results of InvestigatorInitiated Trials ( IITs ) . For clarity, Product Know How includes Documents containing Product KnowHow