definiens: shall mean the following costs incurred by [COMPANY], itsAffiliates or subcontractors in performing IND - Enabling Studies pursuant to Section 3.7.4(a ) or activities under the applicableDevelopment Plan pursuant to Section 3.7.4(b ), as applicable, including the following : ( i ) [COMPANY] FTEs engaged in INDdrafting, preparation and submission ; ( ii ) out - of - pocket costs paid to Third Parties ( such as contract research organizations, testing labs, imaging labs, quality assurance auditors or groups for trial sites or vendors, or other contractors ) for theperformance of such activities on a pass - through basis ; ( iii ) [COMPANY] FTEs planning, performing or overseeing the activitiesunder Section 3.7.4(a ) or ( b ), as applicable at a rate of $ 325,000 per FTE ; ( iv ) [COMPANY] ’s actual costs for obtaining ormanufacturing reasonable quantities of the Development Compound for use as clinical supplies ( such as stability testing ) inperforming [COMPANY] ’s obligations under Sections 3.7.4(a ) and 3.7.4(b ) above ; and ( v ) costs incurred with respect to meeting ofinvestigators ( single site, regional and global ) and associated travel expenses