definiens: means ( a ) with respect to Product or CFE manufact ured by a CMO, Sutro ’s actual costs to acquire the Product or CFE from the CMO together with [ * ] allocation for actual overhead and administrative costs for managing the CMO relations hip, and ( b ) with respect to Product or CFE manufactured by Sutro, [ * ] % of Sutro ’s fully burden ed manufacturing cost of the Product or the CFE, as the case may be, as calculated in accordance with g enerally accepted accounting principles of the Unit ed States ( ) to the extent applicable and the ge nerally applied principles, policies and procedures concerning manufacturing products . Fully burdened m anufacturing cost shall consist of the following : ( i ) Material Cost, which means the standard prices paid for raw material components and purchased fini shed goods [ * ] which are purchased from outside vendors as well as any freight, duties, taxes and other foe s, where applicable . Material Cost includes the quanti ty of the components included in the bill of materi al times the purchase price and the waste factor ( i.e., scrap percentage ) included in the bill of materia ls . It also includes the normal quality assurance sample q uantity included in the bill of materials ; ( ii ) Direct Labor Costs, which means the standard l abor hours required for an operation according to s tandard operating procedures ( including internal manufactur ing of components and products ) multiplied by the direct labor rate for individuals within the releva nt manufacturing operating unit, which labor rate, if for an employee, includes the cost of such employees sa lary, benefits and employer tax burden provided tha t such salaries and benefits are consistent with the salaries and benefits provided to employees in simi lar positions within Sutro not involved in manuf acturing the Product or CFE, as the case may be ; an d ( iii ) Overhead Costs, which means other costs assoc iated with the operating unit(s ) manufacturing the Product or CFE, as the case may be, provided, however, that such Overhead Costs shall exclude [ * ] . Overhead Costs shall include appropriate direct and identifi able costs ( or appropriate allocation thereof ), inc luding expenses associated with quality control, quality a ssurance, manufacturing, engineering services associated with the operating unit(s ) manufacturing a product . Overhead Costs shall also include the f ully loaded allocation of the facility costs ( such as, w ithout limitation, rent, taxes, heat, electricity a nd maintenance ) used to manufacture the Product or CFE, as the case may be, and the allocated costs of manufacturing administration . These costs shall be allocated to each product line in such operating un it(s ) or plant(s ), whichever is applicable, based on spec ific criteria consistent with the standard operatin g procedures for each product, determined and allocat ed in a manner consistently applied within and acro ss its operating units