definiens: or means non - clinical ( including pre - clinical ) and clinical drugdevelopment activities and related research, including : ( i ) assay development, ( ii ) pharmacology studies,(iii ) absorption, distribution, metabolism, elimination ( ADME ) studies, ( iv ) toxicology studies, ( v ) statistical analysisand report writing, ( vi ) test method development and stability testing, ( vii ) process development, ( viii ) formulationdevelopment, ( ix ) delivery system development, ( x ) molecular pathology and biomarker development, ( xi ) qualityassurance and quality control development, ( xii ) compliance related monitoring and activities ( including biometry, datamanagement, drug safety, integrated analysis, and health and economic research ), ( xiii ) manufacture of drug supply(in both active pharmaceutical ingredient and finished product form ) for use in both pre - clinical activities and clinicaltrials, ( xiv ) clinical trials for the purpose of obtaining or maintaining Regulatory Approval ( including post - marketing andmarket expansion studies, ( xv ) safety related studies and risk management programs, ( xvi ) CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT . THE COPY FILEDHEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST . OMISSIONS AREDESIGNATED [ * * * ] . A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THESECURITIES AND EXCHANGE COMMISSION