Approval of the Product in the Field. When used as a verb, Develop means to engage in Development activities.
1.25 Development Plan means a detailed written plan prepared by Licensee for the Development activities to which such plan relates, and which plan shall (a) identify the Development objectives, projected timeline and activities to be conducted pursuant to this Agreement with respect to the Product during the Term; and (b) contain a reasonably detailed budget identifying the anticipated expenses associated with such Development activities. Development Plan includes the Initial Development Plan.
1.26 Disclosing Party has the meaning set forth in Section 11.1.
1.27 Dispute or Disputes has the meaning set forth in Section 14.1.
1.28 EMA means the European Medicines Agency or any successor agency or authority having substantially the same function.
1.29 Europe means Albania, Andorra, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Kosovo, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Moldova, Monaco, Montenegro, Netherlands, North Macedonia (formerly Macedonia), Norway, Poland, Portugal, Romania, San Marino, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom of Great Britain and Northern Ireland, and Vatican City (Holy See).
1.30 Exploit or Exploitation means to research, make, import, export, distribute, use, sell, or offer for sale, including to Develop, Commercialize, register, modify, enhance, improve, hold, keep (whether for disposal or otherwise), transport, distribute, promote, market, or otherwise dispose of, or to have performed any of the foregoing.
1.31 FDA means the U.S. Food and Drug Administration, or any successor agency thereto.
1.32 FFDCA means the Federal Food, Drug and Cosmetic Act under United States Code, Title 21, as amended.
1.33 Field means all human therapeutic uses.
1.34 First Commercial Sale means, on a country-by-country basis, the first sale of a Product by Licensee, its Affiliates or its sublicensees to an end user or prescriber for use, consumption or resale of the Product in a country in the Territory in the Field where Regulatory Approval of the Product has been obtained.
1.35 Force Majeure means any event beyond the reasonable control of the affected Party including, but not limited to, embargoes; war or acts of war, including terrorism; insurrections, riots, or civil unrest; strikes, lockouts or other labor disturbances; epidemics, fire, floods, earthquakes or other acts of nature; or acts, omissions or delays in acting by any governmental authority (including, but not limited to, the refusal of the competent government agencies to issue required Regulatory Approvals due to reasons other than the affected Partys negligence or willful misconduct or any other cause within the reasonable control of the affected Party), and failure of