definiens: shall mean, with respect to the Development of the Product under a Development Plan or an Additional Trial Pla n, ( a ) the Out - of - Pocket Cost for purchasing or the Manufacturing Cost to Manufacture Finished Product for Development Supply Requirements for activities contemplated under such Development Plan or such Ad ditional Trial Plan, as applicable, ( b ) the Out - of- Pocket Cost for purchasing or the Manufacturing Cost to Ma nufacture, comparator agent, combination agent, or placebo requirements for activities contemplated under the applicable Development Plan or such Additional Tria l Plan, as applicable, ( c ) the Out - of - Pocket Cost or the Manuf acturing Cost for filling, packaging, labeling, dev ice 9 manufacture and assembly, and delivery of such Deve lopment Supply Requirements ( or with respect to any Additional Trial, the Product ), comparator agent, c ombination agent or placebo, as the case may be, fo r activities contemplated under such Development Plan or such Ad ditional Trial Plan, as applicable and ( d ) any irre coverable VAT or similar taxes actually paid with respect to the Manufacture or delivery of Development Supply Requirements