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 and economic research),(xv ) manufacture of drug supply ( in both active pharmaceutical ingredient and finished product form ) for use in both pre - clinical activities and clinical trials, ( xvi ) clinical trials for the purpose of obtaining or maintaining Regulatory Approval(including post - marketing and market expansion studies, ( xvii ) safety related studies and risk management programs,(xviii ) support of investigator - initiated clinical trials, ( xix ) new product planning activities, and ( xx ) regulatory affairsactivities related to all of the foregoing