Losses means damages, losses, liabilities, costs (including costs of investigation and defense), fines, penalties, taxes, expenses, or amounts paid in settlement (in each case, including reasonable attorneys and experts fees and expenses), in each case resulting from an Action.
Macau means the Macao Special Administration Region of the PRC.
Manufacture or Manufacturing of the Compound or Licensed Product, as the case may be, means all activities related to the production of the Compound or Licensed Product, as the case may be, including the production of any of the following to the extent used in the Compound or Licensed Product: any drug substance produced in bulk form for use as an active pharmaceutical ingredient, drug product, compounded or finished final packaged and labeled form, and in intermediate states, including the following activities: reference standard preparation, purification, formulation, scale-up, packaging, quality assurance oversight, quality control testing (including in-process release and stability testing), validation activities directly related to all of the foregoing, and data management and recordkeeping related to all of the foregoing. References to Manufacturing activities performed by a Party will include having any or all of the foregoing activities performed by a Third Party.
Manufacturing Technology Transfer has the meaning set forth in Section 4.2(a).
Marketing Authorization means the grant of all necessary final or conditional permits, registrations, authorizations, licenses and approvals (or waivers) required for the importation and Commercialization of the Licensed Product for use in the Field in the Territory, including any Regulatory Approval for sale or marketing, and, where required, Pricing and Reimbursement Approvals.
[***] means Companys product candidate externally known as [***].
NDA means a new drug application or similar application or submission filed with or submitted to any Regulatory Authority to obtain permission to commence marketing and sales of a pharmaceutical product in any particular jurisdiction.
Net Sales means, with respect to a Licensed Product in a Region for any period, the total amounts invoiced for sales of such Licensed Product in such Region for such period by Licensee, its Affiliates or its or their Sublicensees or Commercialization Partners (the Selling Party) to Third Parties that are not Selling Parties in the Territory, in bona fide arms length transactions and as calculated in accordance with the applicable Accounting Standards, less the following deductions, in each case, related specifically to such Licensed Product and actually incurred, paid or accrued by the Selling Party in accordance with the Selling Partys Accounting Standards and not otherwise recovered by or reimbursed to the Selling Party:
(a) discounts (including trade, cash and quantity discounts), cash and non-cash coupons, charge back payments and rebates granted to managed health care organizations, hospitals, pharmacies, or group purchasing organizations, or to federal, state and local governments, their agencies, and purchasers and reimbursers or to customers or required by applicable Law (including governmental medical assistance programs);
(b) [***] credits, allowances, repayments, discounts to and chargebacks for claims, spoiled, damaged, or outdated goods, rejections or returns of the Licensed Products, including Licensed Products returned in connection with recalls or withdrawals;
(c) any sales, value added or similar taxes, insurance, custom duties, excise (including annual fees due under Section 9008 of the United States Patient Protection and Affordable Care Act of 2010 (Pub. L. No. 111-48)) or other similar governmental charges levied directly on the production, sale, transportation, delivery or use of a Licensed Product [***];