Licensee means any non-Affiliate third party granted (a) a license by Parent or its Affiliates under the Company IP to make, have made, use, sell, offer for sale, or import tazemetostat, or (b) a right to distribute tazemetostat, but shall exclude any (i) third party distributor of tazemetostat that has no royalty or other payment obligations to any Parent or any of its Affiliates that are calculated based on amounts invoiced or received by such third party for sales of tazemetostat and (ii) third party distributor of tazemetostat that (x) does not take title to tazemetostat, (y) does not invoice tazemetostat sales to third party customers and (z) is responsible only for inventory management and distribution with respect tazemetostat on behalf of Parent or its Affiliates. For the avoidance of doubt, a distributor that agrees to engage in material commercialization activities with respect to tazemetostat in exchange for discounts that are not made generally available to other distributors shall be deemed to be a Licensee.
Milestone means each of the FDA Approval Milestone and the Net Sales Milestone.
Milestone Amount means each of the FDA Approval Milestone Amount and the Net Sales Milestone Amount.
Milestone Non-Achievement Certificate has the meaning set forth in Section 2.4(d).
Milestone Notice has the meaning set forth in Section 2.4(a)
Milestone Payment Date has the meaning set forth in Section 2.4(a).
Net Sales means the gross amount invoiced by Parent, any of its Affiliates (including the Company) or any of its or their Licensees (each, a Selling Party) to a third party (that is not a Selling Party) for any sales of tazemetostat worldwide (except in, with respect to, or for sale in Japan, the Peoples Republic of China, Taiwan, the Hong Kong Special Administrative Region and the Macau Special Administrative Region), less the following deductions as calculated in accordance with the Accounting Standards:
(i) customary trade, cash and quantity discounts;
(ii) customary wholesaler allowances and inventory management fees, which inventory management fees shall not exceed the percentages permitted under applicable Law in the United States (or if lower, in the country where such fees are being charged);
(iii) rebates, credits, chargeback or allowances given by reason of rejections, returns, damaged or defective product or recalls or on account of retroactive price reductions;
(iv) government-mandated rebates, credits and adjustments paid or deducted;
(v) price adjustments, allowances, credits, chargeback payments, discounts, rebates, free of charge concessions, fees and reimbursements granted or made to managed care organizations, group purchasing organizations or other buying groups, pharmacy benefit management companies, health maintenance organizations and any other providers of health insurance coverage, health care organizations or other health care institutions (including hospitals), health care administrators, patient assistance or other similar programs, or to federal state/provincial, local and other governments, including their agencies;
(vi) freight, shipping, insurance and other transportation expenses, including handling and insurance, to the extent borne by the applicable Selling Party without reimbursement from any third party;
(vii) amounts written off as uncollectable debt; provided, that the amount of any uncollectable debt deducted pursuant to this exception and actually collected in a subsequent Calendar Quarter shall be included in Net Sales for such subsequent Calendar Quarter; and