definiens: or . Develop or Development shall mean non - clinical ( including pre - clinical ) andclinical drug development activities and related research, including : ( i ) chemical lead series generation, ( ii ) medicinalchemistry, ( iii ) assay development, ( iv ) pharmacology studies, ( v ) absorption, distribution, metabolism, elimination ( ADME)studies, ( vi ) toxicology studies, ( vii ) statistical analysis and report writing, ( viii ) test method development and stabilitytesting, ( ix ) process development, ( x ) formulation development, ( xi ) delivery system development, ( xii ) molecular pathologyand biomarker development, ( xiii ) quality assurance and quality control development, ( xiv ) compliance related monitoringand activities ( including biometry, data management, drug safety, integrated analysis, and health 3and economic research, and including the establishment and maintenance of any global safety database as described inSection 3.1(f ) ), ( xv ) manufacture of drug supply ( in both active pharmaceutical ingredient and finished product form ) for usein both pre - clinical activities and clinical trials, ( xvi ) clinical trials for the purpose of obtaining or maintaining RegulatoryApproval ( including post - marketing and market expansion studies but excluding Country - Specific Studies ), ( xvii ) safetyrelated studies and risk management programs, ( xviii ) support of investigator - initiated clinical trials, ( xix ) new productplanning activities, and ( xx ) regulatory affairs activities related to all of the foregoing