1.32 GMP means the then-current good manufacturing practices required by the FDA, as set forth in the FFDCA, as amended, and the regulations promulgated thereunder, for the manufacture and testing of pharmaceutical materials, and comparable applicable Law related to the manufacture and testing of pharmaceutical materials in jurisdictions outside the U.S., including the quality guideline promulgated by the ICH designated ICH Q7A, titled Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients and the regulations promulgated thereunder, in each case as they may be updated from time to time.
1.33 Governmental Authority means any federal, state, national, state, provincial or local government, or political subdivision thereof, or any multinational organization or any authority, agency or commission entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, any court or tribunal (or any department, bureau or division thereof, or any governmental arbitrator or arbitral body).
1.34 IFRS means International Financial Reporting Standards.
1.35 IND means any investigational new drug application, clinical trial application, clinical trial exemption or similar or equivalent application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority.
1.36 Indication means any human diseases, syndromes and medical conditions that can be diagnosed, treated, prevented or ameliorated; provided that all Indications for which one or more Clinical Trials are conducted under one IND will be deemed, for all purposes under this Agreement, the same Indication, regardless of: (a) subtypes of the same disease, (b) different symptoms of the same disease, (c) prevention, treatment or cure of the same disease, (d) product formulation, packaging, dosage amount, dosage form, route of administration, monotherapy vs. combination or add-on therapies, and (e) patients gender and age. Notwithstanding the foregoing, different types of autoimmune diseases and other diseases listed on Exhibit F shall be deemed to be different Indications.
1.37 Know-How means any information and materials, including discoveries, improvements, modifications, processes, methods, assays, designs, protocols, formulas, data, inventions, algorithms, forecasts, profiles, strategies, plans, results, coordinates for compound or protein structures, expression constructs, know-how and trade secrets (in each case, patentable, copyrightable or otherwise), but excluding any Patent Rights.
1.38 Law means any federal, state, local, foreign or multinational law, statute, standard, ordinance, code, rule, regulation, resolution or promulgation, or any order by any Governmental Authority, or any license, franchise, permit or similar right granted under any of the foregoing, or any similar provision having the force or effect of law.
1.39 Licensed Compound means any Compound that is designated by the JSC (or, if the Research Term has ended, by Astellas) for the earlier of: (a) GLP or GMP scale Manufacturing, or (b) first dosing in GLP-toxicology studies using non-human primates, in either case pursuant to Section 3.7.
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