definiens: means the gross amounts invoiced or acc rued on sales of a Product by [COMPANY], or any of its Affiliates or sublicensees, to a Third Party purchaser in an arm’s - length transaction, less the following customary and commercially reasonable deductions, d etermined in accordance with U.S. GAAP and internal policies and procedures of [COMPANY] and actually tak en, paid, accrued, allocated, or allowed based on g ood faith estimates : ( a ) trade, cash and/or quantity discounts, allowances, and credits, excluding commissions for commercialization ; ( b ) excise taxes, use taxes, tariffs, sales taxes and c ustoms duties and/or other government charges imposed on the sale of Products ( including VAT, but only to the extent that such VAT taxes are not reimbursable or refundable ), specifically excluding, for clarity, any income taxes assessed against th e income arising from such sale ; ( c ) compulsory or negotiated payments and cash rebates or other expenditures to governmental authorities ( or designated beneficiari es thereof ) in the context of any national or local health insurance programs or similar programs, including, but not limited to, pay for performance agreements, risk sharing agreements and government - levied fees ; ( d ) rebates, chargebacks, administrative fees, and disc ounts ( or equivalent thereof ) to managed health care organizations, group purchasing organizations, insurers, pharmacy benefit managers ( or equivalent thereof ), specialty pharmacy providers, governmental authorities, or their agencies or purc hasers, reimbursers, or trade customers, as well as amounts owed to patients through co - pay assistance cards o r similar forms of rebate to the extent the latter are direct ly related to the prescribing of the Product ; ( e ) outbound freight, shipment, insurance and other dis tribution costs to the extent included in the price and separately itemized on the invoice price ; ( f ) retroactive price reductions, credits or allowances actually granted upon claims, rejections or returns of the Product, including for recalls or damaged or expired goods, billing error s and reserves for returns ; ( g ) any invoiced amounts that are not collected, and ar e written off, or reserved as bad debt by [COMPANY] or its Affiliates ; and ( h ) any deductions in the context of payments that are due or collected significantly after invoice issuance