definiens: means all costs and expenses ( including material and labor costs, and areasonable allocation of attributable overhead ( including a reasonable allocation of facilities depreciationcosts ) ) of manufacturing, supply, analytical release and stability testing, and clinical formulationdevelopment and scale - up, and other related activities to be performed by or on behalf of Seller under theclinical supply agreement contemplated in Section 8.15, in each case, specifically relating to themanufacture and supply of Compounds and Products, with no mark - up . For clarity, where suchCompound or Product is manufactured or supplied by a third party, Seller ’s Fully Loaded Costs shallinclude the actual fees paid by Seller to the third party, and a reasonable allocation of attributable costsincurred by Seller in managing the applicable third party agreement and related proposals, invoices andpayments and otherwise overseeing the activities of such third party, for such manufacture or supply ofsuch Compound or Product, with no mark - up