definiens: or means the fully burdened cost of alldirect materials and labor and fully allocated manufacturing overhead directly attributable to themanufacture, storage, packaging, and shipping of a Licensed Product, calculated in accordancewith U.S. GAAP and Akebia ’s or its suppliers ’, as applicable, then - prevailing standard procedurefor calculating COGS as reflected in Akebia ’s or its suppliers ’, as applicable, audited financialstatements . COGS includes, without limitation, all bulk API, work in process ( where applicable)and transfer prices paid by Akebia, Licensed Product testing and yield loss costs, quality control, quality assurance, or other testing of Licensed Products, together with all reasonably allocatedindirect costs and overhead applicable to manufacturing of Licensed Product, quality control ortechnical operations functions, less costs of goods returned in accordance with Akebia ’s, or itssuppliers ’, return policy