1.28 “GMP” means all applicable Good Manufacturing Practices, including, as applicable, (a) the principles detailed in the U.S. Current Good Manufacturing Practices, including pursuant to 21 C.F.R. Parts 4, 210, and 211, (b) European Directive 2003/94/EC and Eudralex 4, (c) the principles detailed in the International Conference on Harmonization’s Q7 guidelines, and (d) the Applicable Laws in any relevant country or jurisdiction corresponding to (a) through (c) above, each as may be amended and applicable from time to time.
1.29 “Governmental Authority” means any federal, state, national, 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, or any court or tribunal (or any department, bureau or division thereof, or any governmental arbitrator or arbitral body).
1.30 “IND” means an investigational new drug application or similar application filed with a Regulatory Authority in any country or jurisdiction prior to beginning Clinical Trials in that country or jurisdiction.
1.31 “Invention” means any Know-How, composition of matter, article of manufacture, mechanism of action, method of use, method of manufacture, diagnostic method or prognostic method, or other subject matter, whether patentable or not, that is conceived or reduced to practice under and as a result of the Development, manufacture, or Commercialization of a Licensed Compound or Licensed Product, or the exercise of the licenses granted, in each case under this Agreement.
1.32 “Know-How” means all technical information, data, inventions, discoveries, trade secrets, specifications, instructions, processes, formulae, methods, protocols, expertise and other technology applicable to formulations, compositions or products or to their manufacture, development, registration, use or marketing or to methods of assaying or testing them, and all biological, chemical, pharmacological, biochemical, toxicological, pharmaceutical, physical and analytical, safety, quality control, manufacturing, preclinical and clinical data relevant to any of the foregoing. For clarity, Know-How excludes Patent Rights and physical substances.
1.33 “Licensed Compound” means (a) ASN007, (b) any complex, chelate, clathrate, acid, base, ester, salt, isomer, stereoisomer, diastereoisomer, enantiomer, pro-drug, metabolite, hydrate, solvate, polymorph, tautomer (including any purified tautomer), tautomeric mixture, degradant and any other derivative, crystalline form or combination of a compound described in (a) and (c) any other pharmaceutically active compound (i) the principal mechanism of action of which is to inhibit the Target by directly binding thereto and (ii) the composition of matter of which is claimed by one or more of the Patent Rights listed in Exhibit 1.36 as of the Effective Date.
1.34 “Licensed IP” means, collectively, Licensed Know-How and Licensed Patent Rights.
1.35 “Licensed Know-How” means all Know-How, which (a) is Controlled by Asana or any of its Affiliates as of the Effective Date or during the Term of this Agreement, (b) is not generally known and (c) is reasonably necessary or actually used for the Development, manufacture, use, offer for sale, import, sale or other Commercialization of a Licensed Compound in the Field in the Territory.
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