definiens: shall mean ( a ) the Out - of - Pocket Cost for purchasingor the Manufacturing Cost to Manufacture Formulated Bulk Product for Clinical SupplyRequirements for activities contemplated under the applicable Development Plan, ( b ) the Out - of - Pocket Cost for purchasing or the Manufacturing Cost to Manufacture, comparator agent, combination agent, or placebo requirements for activities contemplated under the applicableDevelopment Plan, ( c ) the Out - of - Pocket Cost or the Manufacturing Cost for filling, packaging, labeling and delivery of such Clinical Supply Requirements, comparator agent, combinationagent or placebo, as the case may be, for activities contemplated under the applicableDevelopment Plan and ( d ) any irrecoverable VAT or similar taxes actually paid with respect tothe Manufacture or delivery of Clinical Supply Requirements . To the extent that ManufacturingCost for comparator agent, combination agent or placebo includes any markup overManufacturing Cost to the benefit of one of the Parties or its Affiliates, such markup shall bededucted in the calculation of Clinical Supply Cost