definiens: means the fully - burdened aggregate reasonable direct andindirect costs and expenses incurred and recorded by a Party in Manufacturing a Product consisting solely 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 ( including start 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, in connection with the Manufacture of aProduct or any component thereof;(g ) any non - refundable or non - creditable indirect taxes, customs and excise duties, or similar taxespaid or payable to any Third Party or Affiliate in relation to the Manufacture of any portion of a Product ; and 6(h ) the reasonable allocation of facility overhead, both fixed and variable, to such Manufacturingoperation ( including the allocable costs of administrators and managers overseeing manufacturing and production)maintenance, engineering, safety, finance, capital equipment depreciation to the extent such capital equipment isutilized with respect to Product, supply chain management, management of agreements with Third Party contractmanufacturers, and inventory write off