definiens: means Supplier 's actual cost of ( a ) raw materials ( including the 4 genetic sub - units ), ( b ) direct labor pl<.ls ( c ) Factory Overhead, in each case, used in manufacturing the Prod<.lcts plus a pro - rata allocation of administrative, supervisory and support personnd e"'penses ( if such expenses are primarily related to the supply hereunder of the Product ) . S<.lch costs and expenses shall be consistently applied and shall be dotcnnincd and allocatod in a manner consistent with generally accepted acconnting principles in effect in the 2 Unit<:<.i States from time to time . Raw materials and direct labor are the actual cost of materials aud labor consumed to manufacture the Products . iucludes an allocalion of building and equipment depreciation and rent and l1tilities . Flmher, Manllfacturing Cost shall excludc any cost or eKpeuses paid by Medlronic and expeuses related te ( i ) research and development, ( ii ) marketing and sales and, ( iii ) fmance, legal and other general corporate overhead . : Manufacturing Cost shall bc dctcnnincd in accordance with, and ~hall be subject to, ExhihitB