Approval Milestone Date definition

Approval 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 Octreotide (as defined in the Merger Agreement), which approval letter grants the Company the right to market and sell Octreotide immediately for the treatment of acromegaly or carcinoid syndrome (the “Approval Milestone”) ; provided, however, that, subject to Section 7(k) hereof, if the Approval Milestone Date does not occur on or before the fourth anniversary of the Offer Closing (the “Approval Deadline”), the Octreotide CCCPs will terminate and all rights thereunder and all rights in respect thereof under this Agreement shall cease.
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Approval Milestone Date means the date on which Borrower achieves the Approval Milestone. “Assignee” has the meaning given to it in Section 11.13. “Blocked Person” means any Person: (a) listed in the annex to, or is otherwise subject to the provisions of, Executive Order No. 13224, (b) a Person owned or controlled by, or acting for or on behalf of, any Person that is listed in the annex to, or is otherwise subject to the provisions of, Executive Order No. 13224, (c) a Person with which any Lender is prohibited from dealing or otherwise engaging in any transaction by any Anti-Terrorism Law, (d) a Person that commits, threatens or conspires to commit or supports “terrorism” as defined in Executive Order No. 13224, or (e) a Person that is named a “specially designated national” or “blocked person” on the most current list published by OFAC or other similar list. “Borrower Products” means all products, software, service offerings, technical data or technology currently being designed, manufactured or sold by Borrower or which Borrower intends to sell, license, or distribute in the future including any products or service offerings under development, collectively, together with all products, software, service offerings, technical data or technology that have been sold, licensed or distributed by Borrower since its incorporation. “Business Day” means any day other than Saturday, Sunday and any other day on which banking institutions in the State of California or the Commonwealth of Massachusetts are closed for business. “Cash” means all cash, cash equivalents and liquid funds.
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Approval Milestone Date means the date on which Borrower achieves the Approval Milestone.
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Examples of Approval Milestone Date in a sentence

  • Rather, it is a statement of an understanding about modalities for cooperation and, as such, is a political rather than a legal docu- ment.58The existing arrangements raise questions about how to address the need for the strengthening of the global financial architecture so that it provides for a level playing field, global financial stability, innovation and market discipline.


More Definitions of Approval Milestone Date

Approval 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 Octreotide (as defined in the Merger Agreement), which approval letter grants the Company the right to market and sell Octreotide immediately for the treatment of acromegaly or carcinoid syndrome the "Approval Milestone")") ; provided, however, that, subject to Section 7(k) hereof, if the Approval Milestone Date does not occur on or before the fourth anniversary of the Offer Closing (the "Approval Deadline"), the Octreotide CCCPs will terminate and all rights thereunder and all rights in respect thereof under this Agreement shall cease.
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Related to Approval Milestone Date

  • 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.