Post-Closing Insect Approval Milestone means that the Company has satisfied the Post-Closing Insect Approval Criteria.
Development Milestone Event shall have the meaning set forth in Section 9.2(a).
Milestone Date means the date set against the relevant Milestone in the Implementation Plan;
Milestone Event has the meaning set forth in Section 8.4.
Milestone 1 means achievement of annual Net Sales of at least $20,000,000 during the Calendar Year ending on December 31, 2021.
Development Milestone Payment shall have the meaning set forth in Section 9.2(a).
Non-Approval Event means, in respect of the Benchmark:
Target Completion Date has the meaning given such term in Section 3.3(b).
Final Approval Date means the date on which the Court enters the Final Order and Judgment.
Milestone Schedule means Seller’s milestone schedule, the form of which is attached to this Agreement as Exhibit Q.
MAA Approval means approval by the EMEA of a marketing authorization application (“MAA”) filed with the EMEA for the applicable Licensed Product under the centralized European procedure. If the centralized EMEA filing procedure is not used, MAA Approval shall be achieved upon the first Approval for the applicable Licensed Product in any two of the following countries: France, Germany, Italy, Spain or the United Kingdom.
Milestone 2 means achievement of annual Net Sales of at least $35,000,000 during any Calendar Year ending on or before December 31, 2024.
Milestone Events has the meaning set forth in Section 3.3 (Milestone Payments).
Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.
NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.
Project Completion Date means the date on which the Completion Certificate is issued;
Application Approval Date means the date that the Application is approved by the Board of Trustees of the District and as further identified in Section 2.3.B of this Agreement.
Project Milestone means the project milestone set forth in Schedule-J;
Post-Closing Straddle Period means the portion of a Straddle Period beginning the day after the Closing Date.
Target Closing Date means three (3) Business Days following receipt of the Approval and Vesting Order, or such other date as the Parties may agree.
project completion period means the period of sixty (60) months commencing from and expiring on for the construction and obtaining of Temporary Occupation Permit or Permits for the whole of the Development as provided in clause 3.3;
Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.
FDA Approval means with respect to the Product, a Regulatory Approval by the FDA for the commercial use of the Product in the United States.
Milestone means an event or task described in the Implementation Plan which must be completed by the corresponding date set out in such plan;
Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).
Final Completion Date means the date on which Final Completion occurs.
Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.