definiens: means a filed with the FDA as described in 21 CFR § 314, or any corresponding application for Regulatory Approval in any country other than the U.S. _ _ _ _ --------- ... --- .. -01Net Sales " means, n a [COMPANY] Product - by - [COMPANY] Product basis, the gross 10306055 _ 4.DOC amoun s InVOice or sales of all such [COMPANY] Products by [COMPANY], its Affiliates and sublicensees ( each a ) to Third Parties which are not sublicensees, less the following deductions, in each case to the extent specifically related to the [COMPANY] Product and taken by the Selling Person or otherwise paid for or accrued by the Selling Person ( ): ( i ) ( ii ) trade, cash, promotional and quantity discounts, and wholesaler fees ; taxes on sales ( such as excise, sales or use taxes or value added taxes ) to the extent imposed upon and paid directly with respect to the sales price ( and excluding national, sales or local taxes based on income ) ; -8 - CF1 - 00369805 10306055 _ 4.DOC ( iii ) freight, insurance, packing costs and other transportation charges to the extent included in the invoice price to the buyer ; i i ( iv ) amounts repaid or credits taken by reason of damaged goods, l rejections, defects, expired dating, recalls, returns or because of