definiens: means, with respect to the Product supplied hereunder, the directand indirect costs incurred by OPKO or its Affiliates determined in accordance with theAccounting Standards and consistent with OPKO ’s internal accounting practices, consistentlyapplied, for the manufacture and supply of Product ( provided that any such indirect costs arereasonably allocable to the manufacture and supply of Product in accordance with theAccounting Standards and consistent with OPKO ’s internal accounting practices, consistentlyapplied ), which costs may include:(a)the cost of active pharmaceutical ingredients, materials, components, supplies and other resources directly or indirectly consumed for the manufacture, testing, andsupply of Product, in each case including freight, insurance, shipping, packaging ( and includingthe cost of packaging ) and other similar costs associated with acquiring such items;(b)labor ( including salaries, wages and current period employee benefits, but specifically excluding expenses associated with stock options or other equity - based ordeferred compensation ), including management salary and benefits reasonably allocable to themanufacture, testing, packaging ( as applicable ) and supply of Product;(c)out - of - pocket expenses paid to a Third Party for the manufacture, testingand supply of Product, including transportation costs, customs, duty and transit insurance costs;(d)scraps and batches that do not conform to the applicable specificationsresulting from the manufacture and supply of the Product to the extent such failure to meet thespecifications and non - conformities are not caused [ * * * ] ; provided that [ * * * ] ; ( e)costs for quality control / assurance ( including the costs of quantitiesdestroyed in quality control testing ) of the Product, including the costs of inspection, rejection andreturn of components, materials or services;(f)costs reasonably allocable to ensuring manufacture and supply operationsfor Product comply with Applicable Laws, including costs for obtaining and maintaining permits, registrations, and authorizations required by Governmental Authorities;(g)other costs reasonably allocable to the manufacture and supply ofProduct, including allocable occupancy, depreciation and amortization of facilities, allocablefacilities costs, general and administrative costs ; and(h)the amount of any royalty payable by OPKO to Catalent PharmaSolutions, LLC ( ) with respect to the use of Catalent Optishell technology