transferee or its Affiliate not so transferred, directly or indirectly, by the Company or its Affiliate shall be considered a Covered Patent.
“First Commercial Sale” means, with respect to a pharmaceutical product in a country, the first bona fide arms-length commercial sale of such product by a Selling Person to a Purchaser in such country after Regulatory Approval has been obtained for such product in such country.
“Net Sales” means, with respect to a Royalty-Bearing Product during a calendar year (or relevant portion thereof) during the Royalty Period, on a Royalty-Bearing Product-by-Royalty-Bearing Product and country-by-country basis, the gross amount invoiced by a Selling Person to a Purchaser, for such Royalty-Bearing Product in such country (“Gross Sales”), less the following deductions:
(a)discounts (including trade, quantity and cash discounts, discounts pursuant to indigent patient programs and patient discount programs), credits, refunds, rebates, chargebacks, retroactive price adjustments, incentives offered to certain indirect customers, including patients, and any other allowances which effectively reduce the net selling price;
(b)returns and allowances, including amounts repaid or credited by reason of defects, rejection, recalls, returns and allowances of goods;
(c)chargebacks and other amounts paid on the sale or dispensing of such Royalty-Bearing Product;
(d)amounts payable resulting from governmental (or agency thereof) mandated rebate programs;
(e)tariffs, duties, and excise, sales, use, value-added and other taxes (other than taxes based on net income) imposed on the production, sale, delivery or use of the Royalty-Bearing Product, or any fees imposed on the pharmaceutical manufacturers by any governmental entity, including any fees under the Patient Protection and Affordable Care Act;
(f)freight, postage, transportation, handling and insurance costs;
(g)uncollectible amounts on previously sold units of Royalty Bearing Products;
(h)wholesaler inventory management fees and wholesaler allowance for distribution expenses; and
(i)any other similar and customary deductions which are in accordance with generally accepted accounting principles, as practiced in the United States or in the applicable country and followed by the relevant Selling Person; provided, however, that in the case of any sale or other disposal for value, such as barter or countertrade, of such Royalty-Bearing Product, otherwise than in an arm’s-length transaction exclusively for money, Net Sales shall be calculated as above on the fair market value of the non-cash consideration received.
Such amounts shall be determined from the books and records of the Selling Person, maintained in accordance with the relevant generally accepted accounting principles, consistently applied. Such amounts shall be determined by applying the Selling Person’s then-current standard procedures and methodology, including its then-current standard exchange rate methodology for the translation of foreign currency into U.S. Dollars or, if applicable, the