definiens: or means, with respect to any ProductManufactured by CANbridge or its Affiliates under this Agreement, the reasonable internal andexternal costs of CANbridge or its Affiliates incurred in Manufacturing such Product, including : ( a)to the extent such Product is Manufactured by CANbridge or its Affiliates, the cost of goods sold ofsuch Product, consisting of direct materials and direct labor costs, plus overhead directlyattributable to Product supplied ( including pre - batch and post - batch specific cleaning, all directlyincurred Manufacturing variances and a reasonable allocation of related Manufacturingadministrative, facilities operations and facilities depreciation costs ( to the extent not otherwiseincluded as direct labor costs or overhead ), which allocation will be mutually agreed in good faithby the Parties, but excluding facilities or plant start - up costs and costs associated with excess oridle capacity ), all calculated in accordance with GAAP in the United States consistently applied, and ( b ) to the extent that such Product is Manufactured by a Third Party manufacturer ( including aCMO ), the actual fees paid by such Party or any of its Affiliates to the Third Party for theManufacture, supply, testing, packaging, labeling and shipping of such Product, and anyreasonable out - of - pocket and direct labor costs actually incurred by such Party or any of itsAffiliates in managing or overseeing the Third Party relationship