Milestone Date means the date set against the relevant Milestone in the Implementation Plan;
Development Milestone Event shall have the meaning set forth in Section 9.2(a).
Milestone 1 means achievement of annual Net Sales of at least $20,000,000 during the Calendar Year ending on December 31, 2021.
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 Event has the meaning set forth in Section 8.4.
Milestone Dates means the dates for completion of specified Project activities as contained in the Project Schedule.
Development Milestone Payment shall have the meaning set forth in Section 9.2(a).
Milestone Events has the meaning set forth in Section 3.3 (Milestone Payments).
Project Milestone means the project milestone set forth in Schedule-J;
Milestone means an event or task described in the Implementation Plan which must be completed by the corresponding date set out in such plan;
Non-Approval Event means, in respect of the Benchmark:
Project Milestones means the project milestones set forth in Schedule-G;
Sales Milestone Payment has the meaning set forth in Section 8.3.1.
Performance Milestone means an act or event specified in section 5.1 and described in section 9 of the EPLA.
Milestone Schedule means Seller’s milestone schedule, the form of which is attached to this Agreement as Exhibit Q.
NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.
Final Approval Date means the date on which the Court enters its Order and Judgment approving the Settlement.
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 Payment means a payment identified in the Implementation Plan to be made following the issue of a Satisfaction Certificate in respect of Achievement of the relevant Milestone;
Milestone Failure means a failure by the Grant Recipient fully to achieve any Milestone by the relevant Milestone Date;
Milestones means control points in the project that help to chart progress. Milestones may correspond to the completion of a key deliverable, allowing the next phase of the work to begin. They may also be needed at intermediary points so that, if problems have arisen, corrective measures can be taken. A milestone may be a critical decision point in the project where, for example, the consortium must decide which of several technologies to adopt for further development.
FDA Approval means the approval of the United States Food and Drug Administration necessary for the marketing, distribution in interstate commerce and sale of the Initial Product (as defined in the Collaboration and License Agreement) in the United States.
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.
Approval Date means the date on which the Plan is approved by the Company’s stockholders.
IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.