definiens: means, with respect to any Product, the amounts inv oiced or received by Vivelix and its Affiliates and Sublicensees for sales of such P roduct in the Field in the Territory to a Third Par ty less the following deductions solely to the extent incurred or a llowed with respect to such sales, and solely to th e extent such deductions from amounts invoiced or received a re in accordance with GAAP applied consistently, an d which are not already reflected as a deduction from the i nvoiced price : ( a ) charge- back payments, rebates, and fees granted or paid to managed health care organizations or to federal, state and local govern ments, their agencies, and purchasers and reimburse rs or to trade customers, in all cases in customary and reasonable amounts ; ( b ) credits or allowances actually granted upon, or rei mbursements for, damaged goods, rejections, or returns of such Product, including r eturns of such Product in connection with recalls o r withdrawals ; ( c ) freight out, postage, shipping, and i nsurance charges for delivery of such Product, to t he extent separately billed on the invoice ; ( d ) taxes or duties levied on, absorbed, or otherwise i mposed on and directly linked to the sale of such Product, including value - added taxes, or ot her gover nmental charges otherwise imposed upon the billed amount, as adjusted for rebates and refunds, to the extent not paid by the Third Party and only to the extent such taxes, charges and other amounts are not reimbursed to the paying party, but excluding all income taxes ; ( e ) distribution fees allowed or paid to Third Party di stributors, brokers, or agents for Product sales outside the United States, other than sales personnel, sales representatives, and sales a gents employed by such Party ( or its Affiliat e ) ; ( f ) the actual amount of any write- offs for bad debt relating to such sales during the applicable period ; and 6 CONFIDENTIAL ( g ) any other deductions from gross invoiced sales amou nts to determine product sales as reported by Vivelix, its Affiliate, or Sublicensee, as applicable, in its financial statements in acco rdance with GAAP ; subject to Idera ’s prior written consent not to be unreasonably withheld, delayed, or conditioned