definiens: means, with respect to each Compound or Licensed Product, the reasonable out - of - pocketcosts, internal costs of a Party or any of its Affiliates, and costs with respect to the supply of such Compound or LicensedProduct ( including placebos ) for use in Clinical Studies, in each case that are incurred after the Effective Date and that areboth specifically attributable to the Development of such Compound or Licensed Product and generally consistent with suchParty ’s Co - Development Activities as specified in the then - current Amplixa Annual Global Development Plan . For purposesof this definition and subject to the conditions set forth above : ( a ) means, with respect to eachCompound or Licensed Product, actual amounts paid to a Third Party, including all license fees ( excluding any payments to aThird Party under the [COMPANY] Sublicense Agreements ) and filing fees required for, and other costs associated with, anyRegulatory Filings applicable to such Compound or Licensed Product ; ( b ) means the applicable FTE Rate(s)multiplied by the actual number of FTEs utilized ; ( c ) with respect to each Clinical Study, unless otherwise agreed by theParties, in no event shall the internal costs incurred by a Party for such Clinical Study, excluding costs with respect to thesupply of the applicable Compound or Licensed Product ( including placebos ) for use in such Clinical Study, exceed * * * * * * * * ( * * * * * * * * % ) of the out - of - pocket costs incurred by such Party therefor ; and ( d ) costs with respect to the supply ofthe applicable Compound or Licensed Product ( including placebos ) for use in Clinical Studies means ( i ) if such Compound orLicensed Product ( or placebo ) is purchased from a Third Party, the actual costs paid by [COMPANY] or [COMPANY] to such ThirdParty with respect to such Compound or Licensed Product ( or placebo ), or ( ii ) if such Compound or Licensed Product ( orplacebo ) is Manufactured by [COMPANY] or any of its Affiliates, [COMPANY] ’s ( or its Affiliate ’s ) fully burdened ( determinedas provided on Schedule 10 attached hereto ) costs for Manufacturing such Compound or Licensed Product ( or placebo )