1.15 “EMA” means the European Medicines Agency, or its successor.
1.16 “EU” means the economic, scientific, and political organization of member states known as the European Union, as its membership may be altered from time to time, and any successor thereto. For the purposes of this Agreement, the United Kingdom shall be deemed to be a member of the EU regardless of the withdrawal of the United Kingdom from the European Union.
1.17 “FDA” means the U.S. Food and Drug Administration, or its successor.
1.18 “Field” means human diagnostic, prophylactic, and therapeutic uses of the Product, including for the prevention, treatment, diagnosis or amelioration of cardiomyopathy due to Friedreich’s ataxia.
1.19 “First Commercial Sale” means, on a country-by-country basis, the first sale of the Product in such country by Licensee, its Affiliates, or Sublicensees to a Third Party for end use of such Product after Regulatory Approval of such Product has been granted in such country. For clarity, [***]
1.20 “Gene Therapy Vehicle” means the viral vector(s) set forth in Exhibit B.
1.21 “Government 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, any court, or tribunal (or any department, bureau or division thereof, or any governmental arbitrator or arbitral body), including Regulatory Authorities.
1.22 “IND” means any investigational new drug application, clinical trial application, clinical trial exemption, or similar or equivalent application filed with the applicable Regulatory Authority for approval to conduct clinical testing of a pharmaceutical product in humans in the applicable country.
1.23 “Inserm Rights” means the intellectual property rights licensed to Licensor pursuant to the Inserm License Agreement.
1.24 “Invention” means inventions, improvements, developments or discoveries, whether patentable or non-patentable, invented or otherwise developed or generated by or on behalf of either Party during the Term in the course of performing activities under this Agreement, whether directly or via its Affiliates, agents, contractors, or sublicensees, and any and all intellectual property rights therein.
1.25 “Know-How” means all technical information, know-how, and data, including inventions, discoveries, trade secrets, specifications, instructions, processes, formulae, compositions of matter, cells, cell lines, assays, animal models, and other physical, biological, or chemical materials, expertise and other technology, including all biological, chemical, pharmacological, biochemical, toxicological, pharmaceutical, physical, and analytical, safety, nonclinical, and clinical data, regulatory documents, data and filings, instructions, processes, formulae, expertise, and information relevant to the research, development, use, importation, offering for sale, or sale of, or which may be useful in studying, testing, or developing, pharmaceutical products.
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