definiens: . Development, as it pertains to Ficlatuzumab, means non - clinical ( including pre - clinical ) andclinical drug development activities and related research, including, among other things : ( i ) pharmacology studies,(ii ) absorption, distribution, metabolism, elimination ( ADME ) studies, ( iii ) toxicology studies, ( iv ) statistical analysisand report writing, ( v ) drug - test method development and stability testing, ( vi ) process development, ( vii ) formulationdevelopment, ( viii ) delivery system development, ( ix ) translational research, ( x ) 4EXECUTION VERSION quality assurance and quality control development, ( xi ) compliance related monitoring and activities ( includingbiometry, data management, drug safety, integrated analysis, and health and economic research ), ( xii ) clinical trialsfor the purpose of obtaining or maintaining Regulatory Approval, ( xiii ) Investigator Sponsored Clinical Studies,(xiv ) safety related studies and risk management programs, ( xv ) preparation of applications for regulatory approval,(xvi ) clinical supply operations, including packaging and labeling a drug for investigational supply and shipping drug toclinical trial sites, and ( xvii ) regulatory affairs related to all of the foregoing . Development, as it pertains to VeriStrat inconnection with Ficlatuzumab, means non - clinical ( including pre - clinical ) and clinical assay development, relatedresearch, analytical development and validation and regulatory submission activities, including development andsubmission of a PMA or CE - IVD submission to be filed with the relevant Regulatory Authority . When used as a verb, means to engage in Development