definiens: or means, with respect to any Licensed Product in [ * * ] ( a ) forproducts and services acquired from or performed by Third Parties, the [ * * ] actual amounts [ * * ] such Third Parties to the extent [ * * ] ; and ( b ) to the extent manufacturing services are performedby [ * * ] or its Affiliates, the fully - burdened cost of all direct materials and labor and fully allocatedmanufacturing overhead directly attributable to the manufacture, storage, packaging, and shippingof a Licensed Product [ * * ], calculated in accordance with the Accounting Standards provided thatfor any Licensed Product manufactured by Akebia, [ * * ] will be excluded from the calculation ofCOGS . In each case ( ( a ) or ( b ) ), COGS includes all [ * * ], Licensed Product testing and yield losscosts, quality control, quality assurance, or other testing of Licensed Products, together with allreasonably allocated indirect costs and overhead applicable to the manufacturing of eachLicensed Product, quality control, or technical operations functions, less costs of goods returnedin accordance with Akebia ’s, or its suppliers ’, return policy