definiens: or means, with respect to a Licensed Compoundand Licensed Product, preclinical and clinical drug development activities, including : the conductof pre - clinical studies ( including the Initial Preclinical Studies ), Clinical Trials, investigatorinitiated studies, synthesis of novel Arginase Inhibitors, biomarker and translational science, testmethod development and stability testing, toxicology, formulation and delivery systemdevelopment, process development, pre - clinical and clinical Licensed Compound and Licensed [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSIONPURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.6EXECUTION VERSION Product supply, manufacturing scale - up, manufacturing technology transfer, development - stagemanufacturing, quality assurance / quality control procedure development and performance withrespect to clinical materials, statistical analysis and report writing and clinical studies, regulatoryaffairs, activities directed toward obtaining Regulatory Approval, and activities conducted under aDevelopment Plan . When used as a verb, means to engage in Development . Forclarity, shall include Required Phase IV Studies