definiens: means ( a ) those out - of - pocket Development costs and expenses paid by OGX to Third Parties pursuant to the Clinical Development Plan ( including any budgets promulgated thereunder and approved by the JSC ), to the extent such costs and expenses are approved by the JSC, ( b ) the direct costs incurred by OGX, measured at the FTE Rate based on the FTEs actually applied by OGX for the OGX employees who perform those activities related to the conduct of the Clinical Studies specified in the Clinical Development Plan, in all cases in accordance with the budget approved by the JSC therefor, or related to terminating a Clinical Study for safety or futility in accordance with Section 3.5(c)(iii ), to the extent such costs are approved by the JSC, and ( c ) the actual costs incurred by OGX prior to the Effective Date as set forth on Schedule 4.3, with all of the foregoing ( under subsections ( a ), ( b ) & ( c ) above ) subject to receipt of appropriate supporting documentation in fonn and substance reasonably acceptable to [COMPANY]