definiens: means each event identified in clause 7 which trigg er a Milestone Payment ; means the payments by United Therapeutics to Supern us of the sum identified in clause 7 on the occurrence of a Milestone Event ; means a New Drug Application and all supplements fi led with the FDA, including all documents, data and other information concerning Li censed Products and Licensed Combination Products which are necessary for, or included in, a Product Approval to market Licensed Products and Licensed Combination Products in the United States of America, as more fully defined in the Act ; means the amount invoiced by United Therapeutics, i ts Affiliates or its Sub - Licensees to Third Parties for the Commercial Sale of Licensed P roducts and Licensed Combination Products in the Territory commencing upon the date of First Commerc ial Sale, after deducting in accordance with GAAP, the following : ( a ) trade, quantity or ordinary discounts including wit hout limitation prompt payment and volume discounts ; 5 ( b ) credits, allowances for Licensed Product and Licens ed Combination Product returns, discounts and rebates to, and chargebacks from, the account o f Third Parties for spoiled, damaged, obsolete, outdated, rejected or returned Licensed P roducts or Licensed Combination Products ; ( c ) sales, use or excise taxes, VAT or other taxes ; or governmental charges incurred in connection with the sale, exportation or importation, transpor tation, or delivery of Licensed Products or Licensed Combination Products in final form ; and ( d ) rebates or similar payments made in connection with sales of Licensed Products and Licensed Combination Products to any governmental or regulat ory authority in respect of any State or Federal Medicare, Medicaid or similar programs in a ny country of the Territory