Amended Approval Milestone Event definition

Amended Approval Milestone Event means after the occurrence of the Approval Milestone Event, the approval of a any new, amended or supplemental New Drug Application and/or Biologics License Application for a Collaboration Product by the FDA in the United States, or equivalent regulatory action in a foreign jurisdiction, to expand the approved clinical indication for such Collaboration Product beyond the indication approved at the time of the Approval Milestone Event.
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Examples of Amended Approval Milestone Event in a sentence

  • Histogenics shall pay Intrexon a milestone payment of one million United States dollars ($1,000,000) within thirty (30) days of each instance of the achievement of the Amended Approval Milestone Event, said payment being made, at Histogenics’ option subject to Section 5.3(b) and 5.3(c), either in cash or in shares of Histogenics’ common stock.

Related to Amended Approval Milestone Event

  • Development Milestone Event has the meaning set forth in Section 7.1.

  • Milestone Event has the meaning set forth in Section 8.4.

  • Milestone Date means the date set against the relevant Milestone in the Implementation Plan;

  • Milestone Events has the meaning set forth in Section 3.3 (Milestone Payments).

  • Development Milestone Payment 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 means an event or task described in the Implementation Plan which, if applicable, must be completed by the relevant Milestone Date;

  • Required Approval has the meaning specified in Section 2.2(b).

  • Non-Approval Event means, in respect of the Benchmark:

  • Project Milestone means the project milestone set forth in Schedule-J;

  • 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 Dates means the dates for completion of specified Project activities as contained in the Project Schedule.

  • Sales Milestone Payment is defined in Section 5.3.

  • 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.

  • 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.

  • 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;

  • 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.

  • 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.

  • Milestone Failure means a failure by the Grant Recipient fully to achieve any Milestone by the relevant Milestone Date;

  • 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.

  • Project Milestones means the project milestones set forth in Schedule-G;

  • Milestone Payment Date has the meaning set forth in Section 2.4(a).

  • Approval Notice means, with respect to any Eligible Loan Asset, the written notice, in substantially the form attached hereto as Exhibit A, evidencing the approval by the Administrative Agent, in its sole discretion, of the conveyance of such Eligible Loan Asset by the Transferor to the Borrower pursuant to the terms of the Purchase and Sale Agreement and the Loan Assignment by which the Transferor effects such conveyance.