1.60. “GLP” means all applicable Good Laboratory Practice standards, including, as applicable, as set forth in the then current good laboratory practice standards promulgated or endorsed by the U.S. Food and Drug Administration as defined in 21 C.F.R. Part 58, or the equivalent Applicable Laws in the Region in the Territory, each as may be amended and applicable from time to time.
1.61. “Governmental Authority” means any court, commission, authority, department, ministry, official or other instrumentality of, or being vested with public authority under any law of, any country, Region, state or local authority or any political subdivision thereof, or any association of countries.
1.62. “GSP” means all applicable Good Supply Practice standards, including, as applicable, as set forth in the then current good supply practice standards promulgated or endorsed by the FDA as defined in Good Supply Practice for Pharmaceutical Products or the equivalent Applicable Laws in the Region in the Territory, each as may be amended and applicable from time to time.
1.63. “ICC Rules” shall have the meaning set forth in Section 15.4(a).
1.64. “Improvement” means [***].
1.65. “IND” means an investigational new drug application, or equivalent application filed with the applicable Regulatory Authority, which application is required to commence Clinical Trials in the applicable jurisdiction.
1.66. “Indemnifying Party” shall have the meaning set forth in Section 12.3.
1.67. “Indemnitee” shall have the meaning set forth in Section 12.3.
1.68. “Indication” means a separate and distinct disease or condition, or sign or symptom of a disease or medical condition. [***].
1.69. “Invention” means any process, method, composition of matter, article of manufacture, discovery or finding, patentable or otherwise, that is invented, discovered or generated as a result of a Party (or the Parties jointly) exercising its (their) rights or carrying out its (their) obligations under this Agreement, including all rights, title and interest in and to the intellectual property rights therein.
1.70. “Joint Global Study” shall have the meaning set forth in Section 5.5(b).
1.71. “Joint Invention” shall have the meaning set forth in Section 13.1(b).
1.72. “Joint Patent” shall have the meaning set forth in Section 13.1(b).
1.73. “JSC” shall have the meaning set forth in Section 3.2(a).
1.74. “Know-How” means any proprietary scientific or technical information, results and data of any type whatsoever, in any tangible or intangible form whatsoever, including databases, safety information, practices, methods, techniques, specifications, formulations, formulae, knowledge, know-how, skill, experience, test data including pharmacological, medicinal chemistry, biological, chemical, biochemical, toxicological and clinical test data, analytical and quality control data, stability data, studies and procedures, and manufacturing process and development information, results and data.
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