Section 1.70. GMP or Good Manufacturing Practice means all applicable then-current standards for Manufacturing, including, as applicable, (a) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. §§ 201, 211, 600 and 610 and all applicable FDA guidelines and requirements, (b) European Directive 2003/94/EC for medicines and investigational medicines for human use and the applicable guidelines stated in the Eudralex guidelines, (c) Pharmaceutical Good Manufacturing Practice of the PRC effective as of March 1, 2011 and its appendices, (d) the principles detailed in the applicable ICH guidelines, (e) the conduct of an inspection by a Qualified Person (as defined therein) and the execution by such Qualified Person of an appropriate certification of inspection and (f) the equivalent applicable Laws in any relevant Region, each as may be amended and applicable from time to time.
Section 1.71. Governmental Authority means any multinational, federal, national, state, provincial, local or other entity, office, commission, bureau, agency, political subdivision, instrumentality, branch, department, authority, board, court, arbitral or other tribunal, official or officer, exercising executive, judicial, legislative, police, regulatory, administrative or taxing authority or functions of any nature pertaining to government.
Section 1.72. ICH means the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.
Section 1.73. Indemnified Party means a Person entitled to indemnification under ARTICLE X.
Section 1.74. Indemnifying Party means a Party from whom indemnification is sought under ARTICLE X.
Section 1.75. Indication means each separate and distinct disease, disorder, illness, health condition, or interruption, cessation or disruption of a bodily function, system, tissue type or organ, for which a separate Regulatory Approval Application is required to be filed to obtain Regulatory Approval.
Section 1.76. Infringement has the meaning set forth in Section 7.3.
Section 1.77. Infringement Action has the meaning set forth in Section 7.3(b).
Section 1.78. Infringement Claim has the meaning set forth in Section 7.4.
Section 1.79. Invention has the meaning set forth in Section 7.1(b).
Section 1.80. Jointly-Invented Patent means any Patent Right claiming any Invention conceived jointly by employees, contractors or agents of Licensee or its Affiliates, on the one hand, and employees, contractors or agents of Company or its Affiliates, on the other hand.
Section 1.81. JSC has the meaning set forth in Section 5.1.
Section 1.82. Know-How means all proprietary chemical and biological materials and other tangible materials, inventions, practices, methods, protocols, formulae, knowledge, know-how, trade secrets, processes, procedures, assays, skills, experience, techniques, information, data and results of experimentation and testing, including pharmacological, toxicological and pre-clinical and clinical test data and analytical and quality control data, whether patentable or otherwise.