definiens: means, with respect to a Product, the FTE Costs and Out - of - Pocket Costs incurred by either Party or any of their respective Affiliates in Manufacturing such Product, in accordance with this Agreement and consistent with the applicable Development Plan or, if applicable, the Commercialization Plan, including : ( a ) to the extent that such Product or its corresponding Licensed Antibody is Manufactured by a Third Party manufacturer, the Out - of - Pocket Costs incurred by a Party or its Affiliates to the Third Party manufacturer for the Manufacture and supply ( including packaging and labeling ) thereof, determined in accordance with the books and records of such Party or its Affiliates maintained in accordance with Accounting Standards ; and ( b ) to the extent that such Product or its corresponding Licensed Antibody is Manufactured by a Pal1y or its Affiliates, direct material costs and FTE Costs attributable to the Manufacture of such Product or its corresponding Licensed Antibody ( excluding the cost of general corporate overhead and administrative personnel ), determined in accordance with the books and records of such Party or its Affiliates maintained in accordance with Accounting Standards