Provide a continuation for this: Source: ETON PHARMACEUTICALS, INC., 10-Q, 11/14/2019
CONFIDENTIAL 1.3 "Applicable Law" means the applicable laws, rules, regulations, guidelines and requirements of any Governmental Entity related to the development, registration, manufacture, importation, commercialization of the Products in the Territory, the manufacture in and export from the Territory of Manufacture, or any obligation under, or related to, this Agreement, including those obligations applicable to the Dossiers. 1.4 "Aucta Background Intellectual Property" means any and all patents and trademarks, patent and trademark applications or other patent and trademark rights, copyrights, inventions, know-how, trade secrets, proprietary knowledge, data, formulations, product specifications and other information owned, licensed to or controlled by Aucta relating to the Products, including but not limited to use, manufacture, and packaging thereof. 1.5 "Aucta Indemnified Parties" shall have the meaning ascribed to the term in Section 13.2 of this Agreement. 1.6 "Breaching Party" shall have the meaning ascribed to the term in Section 11.2 of this Agreement. 1.7 "Business Day" means any day, other than Saturday, Sunday or other day on which commercial banks are authorized or required to close in New York, New York or Rome, Italy. 1.8 "Calendar Quarter" means a three (3) consecutive month period ending on March 31, June 30, September 30 or December 31. 1.9 "Claim" includes a claim, notice, demand, action, proceeding, litigation, prosecution, arbitration, investigation, judgment, award, damage, loss, cost, expense or liability however arising, whether present, unascertained, immediate, future or contingent, whether based in contract, tort or statute and whether involving a Third Party or a Party or otherwise. 1.10 "Confidential Information" shall have the meaning ascribed to the term in Section 9.2 of this Agreement. 1.11 "Dossiers" means the New Drug Applications pursuant to 21 U.S.C. §355(b)(1)-(2), and all amendments and supplements thereof, for the Products as set forth in Exhibit A. 1.12 "Effective Date" shall have the meaning ascribed to the term in Section 11.1 of this Agreement. 1.13 "ETON Indemnified Parties" shall have the meaning ascribed to the term in Section 13.1 of this Agreement. 1.14 "FDA" means the United States Food and Drug Administration and all divisions under its direct control or any successor organizations. 1.15 "Force Majeure Events" shall have the meaning ascribed to such term in Section 15.2 of this Agreement. 2
Source: ETON PHARMACEUTICALS, INC., 10-Q, 11/14/2019
CONFIDENTIAL 1.16 "GMP" means current good manufacturing practices as defined by the FDA. 1.17 "Governmental Entity" means any arbitrator, court, judicial, legislative, administrative, or regulatory agency, commission, department, board, or bureau or body or other government authority or instrumentality or any Person or entity exercising executive, legislative, judicial, regulatory, or administrative functions of or pertaining to government, whether foreign or domestic, whether federal, state, provincial, municipal, or other. 1.18 "Gross Sales" shall have the meaning ascribed to the term in Section 1.26. 1.19 "Indemnitee" shall have the meaning ascribed to the term in Section 13.3.1 of this Agreement. 1.20 "Indemnitor" shall have the meaning ascribed to the term in Section 13.3.1 of this Agreement. 1.21 "Infringement Notification Date" shall have the meaning ascribed to the term in Section 7.4 of this Agreement. 1.22 "Intellectual Rights Suit" shall have the meaning ascribed to the term in Section 7.4 of this Agreement. 1.23 "Losses" means all losses, costs, damages, judgments, settlements, interest, fees or expenses including, without limitation, all reasonable attorneys' fees, experts' or consultants' fees, expenses and costs. 1.24 "Market" or "Marketing" shall have the meaning ascribed to the term in Section 2.1 of this Agreement. 1.25 "NDC" means a national drug code as issued by the FDA. 1.26 "Net Sales" means, with respect to each Product sold in the Territory, the aggregate gross sales amount invoiced by ETON or any sublicensee or other party authorized by ETON to wholesale or distribute the Products on an arms-length basis to Third Parties in the Territory ("Gross Sales"), less (as applicable) the following ETON expenses as accrued and adjusted for amounts actually taken, consistent with ETON'S standard accounting practices in accordance with GAAP: (a) amounts refunded or credited for returned, damaged, outdated, short-dated or defective goods, and bad debts, and (b) all of the following: (i) taxes, duties and other governmental charges related to the production, use or sale of the Products (including, including without limitation the brand manufacturer's tax imposed pursuant to the Patient Protection and Affordable Care Act (Pub. L. No. 111-148) as amended or replaced, but not including taxes assessed against the income derived from such sale); (ii) trade, quantity and cash discounts, allowances, retroactive price adjustments, credit incentive payments, chargebacks, patient support programs, and rebates (including governmental rebates or other price reductions provided, based on sales by ETON to any Governmental Entity or regulatory authority in respect of state or federal Medicare, Medicaid, government pricing or similar programs;); and (iii) any costs incurred in connection with or arising out of compliance with any Risk Evaluation and Mitigation Strategies approved by the FDA and (iv) any expenses associated with serialization of the Products. Distribution of Licensed Products for clinical trials or as samples will not be deemed a "Net Sale" under this definition. 3
Source: ETON PHARMACEUTICALS, INC., 10-Q, 11/14/2019