definiens: or . Develop or Development shall mean non - clinical ( including pre - clinical ) andclinical drug development activities and related research, 2including : ( i ) chemical lead series generation, ( ii ) medicinal chemistry, ( iii ) assay development, ( iv ) pharmacology studies,(v ) absorption, distribution, metabolism, elimination ( ADME ) studies, ( vi ) toxicology studies, ( vii ) statistical analysis andreport writing, ( viii ) test method development and stability testing, ( ix ) process development, ( x ) formulation development,(xi ) delivery system development, ( xii ) molecular pathology and biomarker development, ( xiii ) quality assurance and qualitycontrol development, ( xiv ) compliance related monitoring and activities ( including biometry, data management, drug safety, integrated analysis, and health and economic research ), ( xv ) manufacture of drug supply ( in both active pharmaceuticalingredient and finished product form ) for use in both pre - clinical activities and clinical trials, ( xvi ) clinical trials for thepurpose 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 ) newproduct planning activities, and ( xx ) regulatory affairs activities related to all of the foregoing