Approval With Label Milestone Date definition

Approval With Label Milestone Date means the date on which the Company (or any of its subsidiaries) receives an approval letter from the U.S. Food and Drug Administration (the “FDA”) with respect to its new drug application for Nebido (as defined in the Merger Agreement), which approval letter grants the Company the right to market and sell Nebido immediately and provides labeling for Nebido that does not contain a “boxed warning” (as defined in 21 CFR 201.57(c)(1)) (the “Approval With Label Milestone”); provided, however, that, subject to Section 7(l) hereof, if the Approval With Label Milestone Date does not occur on or before the third anniversary of the Offer Closing (the “Approval Deadline”), the Nebido CCCPs will terminate and all rights thereunder and all rights in respect thereof under this Agreement shall cease; provided, further, that in no event shall the Approval With Label Milestone Date occur if the Approval Without Label Milestone Date shall have already occurred.
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Approval With Label Milestone Date means the date on which the Company (or any of its subsidiaries) receives an approval letter from the U.S. Food and Drug Administration (the "FDA") with respect to its new drug application for Nebido (as defined in the Merger Agreement), which approval letter grants the Company the right to market and sell Nebido immediately and provides labeling for Nebido that does not contain a "boxed warning" (as defined in 21 CFR 201.57(c)(1)) (the "Approval With Label Milestone"); provided, however, that, subject to Section 7(l) hereof, if the Approval With Label Milestone Date does not occur on or before the third anniversary of the Offer Closing (the "Approval Deadline"), the Nebido CCCPs will terminate and all rights thereunder and all rights in respect thereof under this Agreement shall cease; provided, further, that in no event shall the Approval With Label Milestone Date occur if the Approval Without Label Milestone Date shall have already occurred.
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Related to Approval With Label Milestone Date

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

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

  • 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.

  • 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).

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

  • 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.

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • Target Completion Date has the meaning given such term in Section 3.3(b).

  • 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;

  • Milestone Schedule means Seller’s milestone schedule, the form of which is attached to this Agreement as Exhibit Q.

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

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

  • 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.

  • Substantial Completion Date means the date on which Substantial Completion occurs.

  • Sales Milestone Payment is defined in Section 5.3.

  • Final Approval Date means the date on which the Court enters its Order and Judgment approving the Settlement.

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • 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.

  • Final Completion Date means the date on which Final Completion occurs.

  • Completion Date means the date of completion of the Services by the Service Provider as certified by the Procuring Entity

  • Product Schedule means PTC’s standard order form entitled “PTC Product Schedule” (including all schedules, attachments and other document(s) specifically referenced therein) or such alternative order form as may be submitted by Customer and accepted by PTC, in each case that specifies (i) the Licensed Products and/or Services ordered; and (ii) for Licensed Products, the installation address (including the Designated Country) and the Licence Term.

  • 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.