definiens: shall mean, with respect to production of a Licensed Product, the cost of goods incurred by SANO in the production thereof determined in accordance with generally accepted ac counting principles applied on a consistent basis, as determined by SAN O 's independent certified public accountants ; provided, however, th at notwithstanding the foregoing, it being the intent of the parties that Costs make SANO whole with respect to all reasonable expenditures related to the Licensed Product, Costs shall include, without limitation, ( i ) the delivered cost of all ingredients and other raw materials used therei n, ( ii ) a percentage of SANO 's overall labor cost equal to the portion whic h labor hours devoted to the Licensed Product 's production bears to total la bor hours devoted to all SANO product production, ( iii ) packaging and other direct manufacturing and quality control costs and ( iv ) ratably allocated co sts of marketing and promotion ( if any ), product liability insurance and general overhead ; provided, further, that, notwithstanding the forego ing, Costs shall not include ( i ) any cost incurred by SANO in completing the Development Program, ( ii ) any royalties or similar payments paid or payable by SANO with respect to any Licensed Product, or ( i ii ) any cost specifically related to the distribution of the Lic ensed Product outside the United States ; additionally, ( x ) with respect t o the transdermal nicotine Licensed Product ( generic of Habitrol(R ) ) described herein as Product B, Costs shall be reduced on a one - time bas is by [ * * * * ], and ( y ) with respect to the transdermal nitroglycerin produ ct ( generic of Nitro Dur(R ) ) described herein as Product A, Costs shall be reduced on a one - time basis by the sum of the amount set forth as an addi tional Licensed Product Fee for that Licensed Product pursuant to Section 7 .4 hereof