definiens: or . Develop or Development means, with respect to a Product, all activities upto and including development of commercial scale process for such Product, whether such activities are conducted prior to thefiling of the relevant Application(s ) for such Product in the relevant country(ies ) in the relevant Territory or thereafter untilApplication Final Approval of such Product in each such country, including : ( a ) Characterization of such Product ; ( b)preclinical and, if applicable, clinical studies, bioequivalence studies, development of analytical assays, stability studies andquality analysis / quality control development ; ( c ) formulation, process development and development of commercial scaleprocess ; ( d ) validation of commercial scale process ( for drug substance and drug product, as well as associated stabilitystudies ) ( but all costs with respect thereto are included in Commercialization Costs as Commercial Scale Validation Costs ) ; ( e)statistical analysis ; and ( f ) pre - Launch regulatory affairs ( including legal activities with respect thereto )