definiens: ( a ) means the expenses incurred by [COMPANY] or [COMPANY] or for its account after the Effective Date, and which arespecifically attributable to the Development of Development Compounds and Licensed Products, including, withoutlimitation:(i ) costs of preclinical design and evaluation of Candidate Compounds, Development Compounds andLicensed Products, and costs of studies on the toxicological, pharmacokinetic, metabolic or clinical aspects of CandidateCompounds, Development Compounds and Licensed Products ( such costs include the costs of any consultants or other ThirdParties engaged by [COMPANY] to conduct such design or evaluation);(ii ) costs of pre - IND studies including the manufacturing cost of preclinical supplies of CandidateCompounds, Development Compounds and Licensed Products, including GMP materials;(iii ) costs of conducting clinical trails on Development Compounds and Licensed Products including themanufacturing cost of clinical supplies of the Development Compounds and Licensed Products;(iv ) costs of preparing, submitting, reviewing or developing data or information for the purpose of submissionto a Regulatory Authority to obtain approval to Commence Phase 1 Trails or to obtain Regulatory Approval for DevelopmentCompounds and Licensed Products;(v ) fees, including FDA user fees, associated with U.S. and foreign regulatory filings or other U.S. and foreigngovernmental requirements related to Development Compounds and Licensed Products ; 4.(vi ) costs of Third Party licenses under Patents or other intellectual property rights reasonably necessary todevelop Development Compounds or Licensed Products or to commercialize Licensed Products;(vii ) external and internal costs of process development, manufacturing, quality assurance, release testing, andclinical materials relating to Development Compounds or Licensed Products ; and(viii ) such other costs directly incurred in Development of Development Compounds or Licensed Products