or the NMPA prior to beginning clinical trials in humans or any comparable application filed with any Governmental or Regulatory Authority within the Territory.
1.23. “Intellectual Property” means all licensed patents, patent applications, inventions or discoveries (whether or not patentable), copyrights, copyright applications, domain names, Product specifications, data, trade secrets, trade dress, know-how and all other intellectual property rights, and all related documentation or other tangible expressions , including the proprietary information set forth in Exhibit A attached hereto as will be updated from time to time, which are necessary to the Commercialization of the Product within the Territory, but excluding any intellectual property solely relating to the development and manufacture of the Product.
1.24. “Improvements” means any inventions, discoveries, know-how, clinical data or other proprietary information related to the Product created, generated or acquired by either Party during the Term of this Agreement.
1.25. “Laws” means: (a) all constitutions, treaties, laws, statutes, codes, ordinances, guidance, orders, decrees, rules, regulations, and municipal by-laws, (b) all judgments, orders, writs, injunctions, decisions, rulings, decrees and awards of any governmental, regulatory or judicial authority, and (c) all policies, practices and guidelines of any governmental or regulatory authority.
1.26. “Losses” means any and all claims, liabilities, losses, damages, fees, penalties, judgments, awards, interest, costs and expenses (including, without limitation, reasonable attorneys’ fees and expenses and court’s costs) incurred by a Party to this Agreement, or any Affiliate thereof, resulting from a third party Proceeding against either Party.
1.27. “NDA” means a New Drug Application filed with the FDA, the EMEA, the NMPA and other Regulatory Authorities to obtain approval for commercial sale or use of the Product as a pharmaceutical or medicinal product in any formulation or dosage form (excluding any pricing and reimbursement approvals) or any comparable application filed with any Governmental or Regulatory Authority within the Territory.
1.28. “Net Sales” means the gross amount invoiced for sales of the Product by CASI, or its Affiliates or its permitted sublicensee to any third party in the Territory, less the following amounts: (i) sales taxes or other taxes separately stated on the Product invoice; (ii) price adjustments, credits, refunds or deductions for returned or defective Product, all to the extent reasonably demonstrated by CASI by written records, provided that such calculation is not in violation of the Generally Accepted Accounting Principles (GAAP) of the United States. Notwithstanding anything in this Agreement to the contrary, the transfer of the Product between or among CASI and any of its Affiliates and sublicensees will not be considered a sale.
1.29. “Person” means an individual, corporation, partnership, limited liability company, trust, business trust, association, joint stock company, joint venture, pool, syndicate, sole proprietorship, unincorporated organization, governmental authority or any other form of entity not specifically listed herein.