definiens: means the fully - burdened cost of manufacturing the Product, including the cost of ( i ) raw materials other than API used in the actual production, bulk labelling and bulk packaging of Product, ( ii ) direct labour of Jagotec employees or its Affiliate 's employees ( including basic wages, labour and related payroll taxes and benefits ) incurred or spent in the actual production, bulk labelling and bulk packaging of Product, including without limitation for quality assurance and manufacturing facility operations, and ( iii ) overhead of Jagotec and its Affiliates ( including operating expenses, indirect labour and related payroll taxes and benefits, depreciation, applicable taxes, insurance, repairs and maintenance, supplies ) incurred or spent in support of the actual production, bulk packaging and bulk labelling of Product, but not for cost of any unused manufacturing capacities that Jagotec may have in excess of the requirements contained in the forecasts provided by CRTX, and, in the case of ( ii ) and ( iii ) above, excluding taxable benefits, remuneration based on profitability or bonuses, and ( iv ) ( without prejudice to delivery being Ex Works hereunder ) any transportation, storage, non - reimbursable import or export taxes of or for Product as may be incurred or spent by Jagotec or its Affiliates in connection with the supply of Product pursuant to the terms of this Agreement, all as determined in accordance with generally accepted accounting principles consistently applied ; provided, however, any increase in the overhead of Jagotec and its Affiliates shall not exceed,§,% of their overhead of the previous Year