definiens: means, with respect to any Licensed Product, the gross amount received by Licensee, its Affiliates or its Sub licensees ( each, a ) for Sales of such Licensed Product in the applicable country to a Third Party that is not a Sublicensee, following Regulatory Approval of such Licensed Product, less ( i ) credits for sales returns and allowances actually paid, granted or accrued, ( ii ) trade, quantity and cash discounts and any other adjustments actually allowed and taken with respect to such invoiced amounts, including those granted on account of price adjustments, billing errors, damaged or defective good s, recalls, returns, rebates, chargeback rebates, reimbursements or similar payments granted or given to wholesalers or other distributors, as well as retroactive price adjustments, ( iii ) customs or excise duties, sales tax, consumption tax, value added ta x, government user fees and other taxes ( except income taxes ) or duties relating to sales, in each case invoiced as a specific line item in an invoice ( to the extent such taxes are actually incurred by the Selling Party, and are not reimbursable, refundabl e or creditable to the Selling Party ) ; and ( iv ) freight, transportation and insurance levied on the invoiced amount, in each case invoiced as a specific line item in an invoice ( to the extent that the Selling Party actually incurs the cost of freight and i nsurance for a Licensed Product and such amounts are not reimbursable, refundable or creditable to the Selling Party ), in each of ( i ) through ( iv ) as determined in accordance with generally acceptable accounting principles in the United States, consistentl y applied . For purposes of the foregoing, Net Sales shall not include any Sale of any Licensed Products sold or used for development purposes ( including, without limitation for clinical studies ) or as samples or free goods ( including, without limitation, p roduct transferred in connection with patient assistance programs, named patient programs or charitable purposes ) . Sales of Licensed Product among Licensee, its Affiliates or Sublicensees shall be excluded from the computation of Net Sales, and shall not b e Sales, if such sales are not intended for end use, but Net Sales shall include the subsequent final Sales to any Third -Party customers by a Selling Party . In the event that a Licensed Product is a Combination Product, the Net Sales of such Combinatio n Product, for the purposes of determining royalty payments pursuant to this Agreement, shall be determined by [ * * * ] . If the Licensed Product and Other Components are not sold separately in the applicable country or territory, Net Sales for the purposes of determining royalty payments under this Agreement shall be calculated by [ * * * ]