definiens: means, as to Product, the direct and identifiable internal and external costs of manufacturing, packaging and shipping such Product, consisting of the following : ( i ) with regard to a Party ’s or its Affiliates ’ internal costs and charges, Cost of Goods shall include the direct costs and charges, including API and other materials, manufacturing plant overhead c harges reasonably allocable to the Product, quality oversight ( including stability and annual product reviews ) an d ( starting in the first year of the commercializat ion of the Finished Product ) GDUFA or similar manufacturing fa cility fees, in each case related to such manufactu re, packaging and shipment, and shall exclude ( A ) costs and charges related to or occasioned by unused manufacturing capacity ; ( B ) the manufacture of othe r products at such Party ’s facilities ; ( C ) amortiza tion of property, plant or equipment not specifically relat ed to manufacturing of Product ; and ( D ) any allocat ion of general corporate overhead ; and ( ii ) with regard to a Party ’s or its Affiliates ’ external costs and ch arges, Cost of Goods shall include the commercially reasonable inv oiced costs and charges of suppliers of goods and s ervices directly related to the manufacture, packaging and shipment of Product, quality oversight ( including s tability and 3 annual product reviews ) and ( starting in the first year of the commercialization of the Finished Produ ct ) GDUFA or similar manufacturing facility fees, as well as the costs of API and other materials directly sourc ed by a Party, in each case related to such manufacture, packaging and shipment . A Party ’s Cost of Goods shall be det ermined on an accrual basis in accordance with U.S. general ly accepted accounting principles, applied on a bas is consistent with such Party ’s annual audited financi al statements . For the avoidance of doubt, shipping costs included in the Cost of Goods definition include co sts relating to the shipment of the API, the Bulk P roduct and the Finished Product to their intended destinations, but do not include the cost of shipping the Finis he d Product from the [COMPANY] distribution center to the intende d customers . Those costs are included in the Sales Allowance