definiens: means the directly allocable out -of - pocket costs of development ( but not capital investment costs ), plus FTE Charges, incurred by CVT or FHI in accordance with Section 3.4(a ) in conducting their respective work under this Agreement and the Development Program in acc ordance with the Development Plan, including, without limitation, costs associated with preparation and filing of submissions for Regulatory Approvals for Licensed Compounds and/or Licensed Products . Development Costs do not include any costs associated with marketing, sales, promotion or distribution of Licensed Compounds and/or Licensed Products . With respect to the manufacture and supply of Licensed Compounds and/or Licensed Products, Development Costs shall only include ( i ) the directly allocable out -of - pocket costs ( but not capital investment costs ), plus FTE Charges, incurred by CVT in conducting CVT Manufacturing Activities under Section 3.4(a ) up to and in connection with FDA approval of the first NDA for the first Licensed Product hereunder, and ( ii ) the directly allocable out -of - pocket costs ( but not capital investment costs ), plus FTE Charges, incurred by FHI in conducting FHI Manufacturing Activities under Section 3.4(a ) up to and in connection with FDA approval of the first NDA for the first L icensed Product hereunder, and the Parties specifically agree that the costs and FTE Charges specifically included within Development Costs under the foregoing clauses ( i ) and ( ii ) shall include all directly allocable out -of - pocket costs ( but not capital i nvestment costs ), plus FTE Charges, incurred by CVT or by FHI in preparing, conducting or completing the Validation Package, irrespective of whether the timing of completion of some of said validation activities relating to the first NDA for the first Lice nsed Product is before or after the receipt of FDA approval of the first NDA for the first Licensed Product . In any event, with respect to the manufacture and supply of Licensed Compounds and Licensed Products, Development Costs shall not include the costs of producing any Licensed Compounds and/or Licensed Products which could be sold commercially as determined by the Management Committee . In no event shall such directly allocable out -of - pocket costs include any costs which are otherwise included in FTE Ch arges . ” 5 . FHI Development Technology