definiens: means fully burdened internal and external costs of developing and manufacturing a LicensedProduct, excluding the Active Pharmaceutical Ingredient in a Licensed Product ( as this will be supplied by NovoNordisk to Zosano free - of - charge ), consisting of the following : [ * * ] and shall exclude ( i ) costs and charges related to oroccasioned by unused manufacturing capacity not otherwise committed to Licensed Product ; ( ii ) the manufacture ofother products at Zosano ’s facilities ; ( iii ) amortization of property, plant or equipment not specifically related to thedevelopment or manufacturing of Licensed Product, and ( iv ) allocation of general corporate overhead ; and ( b ) withregard to external costs and charges these shall include the actual invoiced costs and charges of suppliers of goodsand services directly related to the manufacture and shipment of Licensed Product . Manufacturing Cost shall bedetermined on an accrual basis in accordance with GAAP, applied on a basis consistent in the annual auditedfinancial statements