1.31 Drug Approval Application means a New Drug Application (an NDA) as defined in the FFDCA and the regulations promulgated thereunder (including all additions, supplements, extensions and modifications thereto), or any corresponding foreign application in the Territory, including, with respect to the European Union, a Marketing Authorization Application (an MAA) filed with the EMA pursuant to the centralized approval procedure or with the applicable Regulatory Authority of a country in Europe with respect to the mutual recognition or any other national approval procedure (including all additions, supplements, extensions and modifications thereto).
1.32 Effective Date has the meaning set forth in the preamble hereto.
1.33 EMA means the European Medicines Agency and any successor agency thereto.
1.34 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, Croatia, 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.
1.35 Executive Officers means the Chief Executive Officer of X4 and the Head of Strategy & Business Development of Genzyme (or his/her designee).
1.36 Exploit means, with respect to a Licensed Product, to make, have made, import, have imported, use, sell or offer for sale, research, Develop, Commercialize, register, Manufacture, have Manufactured, hold or keep (whether for disposal or otherwise), have used, export, have exported, transport, distribute, have distributed, promote, have promoted, market or have sold or otherwise dispose of such Licensed Product and Exploitation means the act of Exploiting a Licensed Product.
1.37 FDA means the United States Food and Drug Administration and any successor agency thereto.
1.38 FFDCA means the United States Food, Drug, and Cosmetic Act, as amended from time to time.
1.39 Field means all therapeutic, prophylactic and diagnostic uses in humans for all indications, excluding (a) the Mozobil Indications, and (b) any use for Auto-HSCT Treatments and Allo-HSCT Treatments.
1.40 Financial Commitment means a private placement of capital or debt ownership interests or securities of X4 (including rights or options to acquire ownership interests) which results in aggregate proceeds to X4 of at least [***].
Portions of this Exhibit, indicated by the mark [***], were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrants application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.