definiens: Development Costs " means the directly allocable out - of - pocket costs ofdevelopment ( but not capital investment costs ), plus FTE Charges, incurred by CVT or FHI inaccordance with Section 3.4(a ) in conducting their respective work under this Agreement and theDevelopment Program in accordance with the Development Plan, including, without limitation, costs associated with preparation and filing of submissions for Regulatory Approvals forLicensed Compounds and/or Licensed Products . Development Costs do not include any costsassociated with marketing, sales, promotion or distribution of Licensed Compounds and / orLicensed Products . With respect to the manufacture and supply of Licensed Compounds and / orLicensed Products, Development Costs shall only include the directly allocable out - of - pocketcosts ( but not capital investment costs ), plus FTE Charges, incurred by CVT in conducting CVTManufacturing Activities under Section 3.4(a ), and the directly allocable out - of - pocket costs ( butnot capital investment costs ), plus FTE Charges, incurred by FHI in conducting FHIManufacturing Activities under Section 3.4(a ), and in any event shall not include the costs tomanufacture registration batches run at gleater than ten percent ( 10 % ) of commercial scale or thecosts of producing any Licensed Compounds and/or Licensed Products which could be soldcommercially . In no event shall such directly allocable out - of - pocket costs include any costswhich are otherwise included in FTE Charges