Post-Closing Insect Approval Milestone means that the Company has satisfied the Post-Closing Insect Approval Criteria.
Development Milestone Event has the meaning set forth in Section 7.1.
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 its Order and Judgment approving the Settlement.
Milestone Schedule means Seller’s milestone schedule, the form of which is attached to this Agreement as Exhibit Q.
MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.
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;
FDA Approval means the approval by the FDA of a premarket approval application to market and sell a Product, as evidenced by the publication of such approval by the FDA.
Milestone means an event or task described in the Implementation Plan which, if applicable, must be completed by the relevant Milestone Date;
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 a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).
Initial approval means authorization to admit students and enter into contractual agreements for clinical facilities. It is granted only after an application has been submitted, reviewed and a survey visit made by the Board. No students shall be admitted to the program until the institution has received written notification that initial approval has been granted. Failure to comply will delay initial approval.