definiens: means an application for approval to market commercially such as ( or any successor process to ) theNew Drug Application filed pursuant to the requirements of the United States Food and Drug Administration ( orany successor body ), as more fully defined in 21 CFR.§ 314.3 et seq, or a Biologics License Application filedpursuant to the requirements of the United States Food and Drug Administration ( or any successor body ), asmore fully defined in 21 CFR § 601, or any equivalent or similar application filed with any other CompetentAuthority in any country or region in the Territory, together, in each case, with all additions, deletions orsupplements thereto ; means the aggregate sums received by CRT in respect of any commercial exploitation of aLicensed Product, after the deduction of all Expenses ; for any given period means the gross aggregate amount invoiced on account of sales of LicensedProduct by [COMPANY] or any of its Affiliates or Sub - Licensees in the Territory ( but not including sales betweenTeva, its Affiliates or Sub - Licensees where the Licensed Product is intended for resale ) less the followingdeductions directly relating to such sales of Licensed Product, each to the extent actually incurred based onsuch sale, all determined in accordance with the standard practices of [COMPANY] and its Affiliates for their otherpharmaceutical products, consistently applied . At CRT ’s request, [COMPANY] shall explain to CRT such standardpractices and shall respond promptly to any questions CRT poses in connection therewith : a)cash discounts given off the invoiced price and, with respect to sales in the U.S., a standard [ * * * ] discount solely to the extent that the standard U.S. discount forms part of the standard practices ofTeva and its Affiliates for their other pharmaceutical products and is actually and consistentlyapplied ; b)reasonable estimates for rebates, price reductions, coupons, vouchers, and co - pay assistancereimbursements given in the ordinary course of business which are not already reflected in theamount invoiced ; c)reasonable estimates for any adjustments, credits or allowances on account of price adjustments, billing errors, shelf stock adjustments and discounts to price, such as promotional payments, howsoever referred to by the relevant customer ; d)reasonable estimates for rejected goods, damaged goods and returns, withdrawal, recall or relabelingof the Licensed Product ; e)reasonable estimates for credits, volume rebates, charge - back and prime vendor rebates, fees, reimbursements or similar payments granted or given to wholesalers and other distributors, buyinggroups, health care insurance carriers, pharmacy benefit * * * Certain information on this page has been omitted and filed separately with the Commission . Confidentialtreatment has been requested with respect to the omitted portions