definiens: DocU : NYl234 : 4325332.2 means any New Drug Application in relation to a Product(s ) filed by [COMPANY] or its approved designee with the FDA or a similar application filed in another jurisdiction ; means with respect to the Product(s ) the gross amount invoiced by [COMPANY], its Affiliates and/or any sub­licensee of [COMPANY] or its Affiliates to . unrelated third parties for the Product(s ) less the following seven items : ( a ) trade quantity and cash discounts actually allowed ; ( b ) commission, discounts, refunds, rebates, charge backs, retroactive price adjustments, and any other allowances which effectively reduce the net selling price ; ( c ) actual product returns and allowances ; ( d ) that portion of the sales value associated with non pharmaceutical drug delivery devices ( not to include [COMPANY] 's Carriers ) ; ( e ) any tax imposed on the production, sale, delivery or use of the Product(s ) ; ( f ) allowance for distribution ( transportation ) expenses ( limit of Fi'"':5o / cl of gross sales ) ; ( g ) any other similar, reasonablhrur'customary deductions which are properly recorded as a reduction of sales under GAAP, consistently applied