definiens: means, with respect to a Collaboration Product, the gross amount invoicedfor sales of such Collaboration Praductto customers which are not Affiliates ( or which are Affiliates butare end users of such Collaboration Product ), less the following uhreimbursed or non - refunded deductionswith respect thereto, determined in accordance with GAAP and calculated in United States dollars and tothe extent such amounts have not already been deducted from the amount invoiced : ( a ) amounts actuallyallowed as volume or quantity discounts, rebates, price reductions, returns ( including recalls ) and charge - backs ( including without limitation, with respect to any Net Sales in Japan, any sales - based contributionfor and any sales - based contribution for in each case as required by applicable Laws or Regulatory Authority in the amount determinedby and payable to the Pharmaceuticals and Medical Devices Agency ( so - called », ( b ) sales, excise and turnover taxes and similar duties, levies and charges collected, charged or otherwise imposeddirectly upon and actually paid by such party and its Affiliates, and ( c ) all other direct expenses ordiscounts, including but not limited to cash discounts, custom duties and transportation and insurancecharges