definiens: means, with respect to a Finished Product, the fully - burdened aggregate reasonabledirect and indirect costs and expenses incurred and recorded by Arena in manufacturing such Finished Product consistingsolely of : ( a ) direct labor costs ( salaries, wages, employee benefits, overtime costs and shift premiums ) ; ( b ) direct materials(including raw materials and intermediates and packaging ) costs ; ( c ) operating costs of facilities and equipment ( includingstart up and cleaning costs of production ) ; ( d ) quality, release and in - process control costs ; ( e ) charges for reasonable spoilage, scrap or rework costs ; ( f ) amounts ( without markup ) that are paid to a Third Party, [COMPANY], or an Affiliate of [COMPANY] in connectionwith the manufacture of such Finished Product or any component thereof ; and ( g ) the reasonable allocation of Facilityoverhead, both fixed and variable, to such manufacturing operation ( including the allocable costs of administrators andmanagers overseeing manufacturing and production ), in each case ( ( a ) through ( g ) ), to the extent specifically identifiable tothe manufacture of such Finished Product as determined in accordance with GAAP