1.34 “Europe” means the countries comprising the European Economic Area as it may be constituted from time to time, which as of the Effective Date consists of the member countries of the European Union, Iceland, Norway, Liechtenstein and Switzerland.
1.35 “European Union” means the economic, scientific and political organization of member states as it may be constituted from time to time, which as of the Effective Date consists of Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom of Great Britain and Northern Ireland and that certain portion of Cyprus included in such organization. For avoidance of doubt, European Union includes the United Kingdom and any other country that is a member of the European Union on the Effective Date even if such country ceases to be a member of the European Union during the Term.
1.36 “Executive Officers” means the Chief Executive Officer of Licensee and the Senior Vice President, Research and External Science and Innovation of Allergan.
1.37 “Exploit” means, with respect to a Licensed Product, to make, have made, import, use, sell or offer for sale, including to research, Develop, Commercialize, register, Manufacture, have Manufactured, hold or keep (whether for disposal or otherwise), have used, export, transport, distribute, promote, market or have sold or otherwise dispose of such Licensed Product and “Exploitation” means the act of Exploiting a Licensed Product.
1.38 “FDA” means the United States Food and Drug Administration and any successor agency thereto.
1.39 “FFDCA” means the United States Food, Drug, and Cosmetic Act, as amended from time to time.
1.40 “Field” means all fields, including the treatment of diseases and conditions of the central nervous system covering functional retraining, cognition, and psychological retraining, which includes Alzheimer’s disease, cognitive disorders, depression, traumatic brain injury, amblyopia, stroke, Parkinson’s disease, schizophrenia, addiction, anxiety and stress disorders.
1.41 “First Commercial Sale” means, with respect to a Licensed Product in the Field in a country in the Territory, the first sale to a Third Party for monetary value for use or consumption by the general public of such Licensed Product in such country after the applicable Regulatory Authority has approved the Drug Approval Application for such Licensed Product in such country. Sales prior to the approval of the applicable Drug Approval Application, such as so-called “treatment IND sales”, “named patient sales” and “compassionate use sales”, shall not constitute a First Commercial Sale.
1.42 “Force Majeure Event” has the meaning set forth in Section 11.1.
1.43 “GAAP” means United States generally accepted accounting principles, consistently applied.
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