1.34. “Exploit” means, with respect to a product, to use, have used, Develop, have Developed, Manufacture, have Manufactured, Commercialize, have Commercialized or otherwise exploit such product and “Exploitation” means the act of Exploiting a product.
1.35. “FDA” means the United States Food and Drug Administration and any successor agency thereto.
1.36. “FFDCA” means the United States Food, Drug, and Cosmetic Act, as amended from time to time.
1.37. “Field” means all human therapeutic, prophylactic and diagnostic uses.
1.38. “First Commercial Sale” means, with respect to a Licensed Product in a country in the Territory, the first sale to a Third Party for monetary value for use or consumption by the general public of such Licensed Product in such country after the applicable Regulatory Authority has approved the Drug Approval Application for such Licensed Product in such country. [***].
1.39. “Force Majeure Event” has the meaning set forth in Section 13.1.
1.40. “Generic Market Share” means with respect to a particular market segment in a particular country, the total [***], as measured by reputable published data for such country for example, market share data collected by IQVIA and other similar Third Party organizations. For example, [***].
1.41. “Generic Product” means any pharmaceutical product that is (a) sold in a country under Market Approval by a Third Party who is not a Sublicensee, (b) contains a Licensed Compound, and (c) can be sold or is used for the same Indication or Indications as any Licensed Product actually sold in such country by Licensee or its Affiliate or Sublicensee.
1.42. “Hatch-Waxman Act” means the Drug Price Competition and Patent Term Restoration Act of 1984, as amended.
1.43. “IND” means an investigational new drug application filed with the FDA for authorization to commence Clinical Studies in the United States (including all additions, supplements, extensions and modifications thereto), or any corresponding foreign application in the Territory.
1.44. “Indemnification Claim Notice” has the meaning set forth in Section 11.3.
1.45. “Indemnified Party” has the meaning set forth in Section 11.3.
1.46. “Indemnifying Party” means the Party from whom indemnification is sought pursuant to Section 11.1 or Section 11.2.
1.47. “Indication” means any distinct human disease category, as evidenced by the filing of a separate Drug Approval Application (or supplemental Drug Approval Application, as the case may be).
1.48. “Information and Inventions” means all technical, scientific and other know-how and information, trade secrets, knowledge, technology, means, methods, processes, practices, formulas, instructions, techniques, procedures, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, including pre-clinical trial results and Clinical Study results, Manufacturing procedures, test procedures, and purification and isolation techniques, (whether or not confidential, proprietary, patented or patentable) in written, electronic or any other form now known or hereafter developed, and all other discoveries, developments, inventions, and tangible embodiments of any of the foregoing.
1.49. “Infringement” has the meaning set forth in Section 7.3.1.
1.50. “Infringement Notice” has the meaning set forth in Section 7.3.1.
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