testing of medical devices and/or pharmaceutical materials, as applicable, in jurisdictions outside the EU, as may be updated from time to time. Good Manufacturing Practices shall include applicable quality guidelines promulgated under the ICH.
1.56 Governmental Authority means any court, agency, department, authority, or other instrumentality of any multi-national, national, state, county, city, province, or other political subdivision.
1.57 IFRS means International Financial Reporting Standards, consistently applied.
1.58 Insolvency Event means, in relation to either Party, any one of the following: (a) filing by such Party in any court or agency pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization, or for an arrangement or for the appointment of a receiver or trustee of the Bankrupt Party or of its assets; (b) such Party being served with an involuntary petition against the Bankrupt Party, filed in any insolvency proceeding, which petition shall not be dismissed within one-hundred twenty (120) days after the filing thereof; (c) such Party proposing or being a party to any dissolution or liquidation of such Party; or (d) such Party making a general assignment for the benefit of creditors.
1.59 Intellectual Property Rights means any and all proprietary or intellectual property rights, in, to, or under any of the following, whether protected, created or arising under any jurisdiction or under any international convention: (a) inventions (whether or not patentable or reduced to practice); (b) Patent Rights; (c) trademarks, service marks, trade dress, domain names, corporate, trade, and business names, certification marks, logos, slogans and other indicia of origin, whether registered or unregistered, and all registrations and applications for the same (including all translations, adaptations, derivations, and combinations of the foregoing), and all goodwill of the business connected with the use of and symbolized by the foregoing; (d) all copyrights and works of authorship, (including in software, data, databases, and collections of data, design rights and economic rights) whether registered as copyrights or unregistered, all registrations and applications for the same and all associated moral rights and special rights of authorship; (e) Know-How; (f) trade secrets; (g) all other intellectual property rights, proprietary rights and industrial property rights, or other intangible assets, of every kind and nature however denominated; and (h) all registrations, renewals, recordations and applications of or for any of the foregoing.
1.60 Know-How means any and all know-how, data, including inventions (whether patentable or not), discoveries, trade secrets, technical information, formulae, materials, expertise and information, testing and manufacturing processes, instructions, techniques, methods and data, physical and analytical, safety, quality control, manufacturing, preclinical and Clinical Trial Data, medical uses, product forms and product drawings and specifications, in each case relevant to the Development, Manufacture, use, or Commercialization of and/or which may be useful in studying, testing, development, or production of medical device technologies.
1.61 Later Acquired Acutus Know-How means such Know-How that is Controlled by Acutus or any of its Affiliates beginning and after the Effective Date that is conceived of by Acutus or any of its Affiliates or Sublicensees in performance of Acutus Development, Manufacture, and Commercialization, as applicable, of the FS Product Line or External Products, and which is reasonably necessary for the Commercialization of the FS Product Line or External Products.
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