FDA Milestone Date definition

FDA Milestone Date means the date that the FDA Milestone occurs.
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FDA Milestone Date means the date that the FDA approves brentuximab vedotin for sale and marketing.
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Examples of FDA Milestone Date in a sentence

  • This agreement shall not be assigned either by the parties or by operation of law without prior written consent of the other party; however, in the case of Gliatech, Gliatech may, without obtaining the consent of the Manufacturers Representative, assign its rights and obligations under this Agreement to any corporation with which Gliatech may merge or consolidate or to which Gliatech may transfer substantially all of its assets.

  • Notwithstanding any other provision of the Plan, all Stock Awards to Covered Employees under the Plan shall be subject to the approval by the Company’s stockholders of an amendment to the Equity Incentive Plan at the annual stockholder meeting for the Company that occurs in 2010, and in all cases prior to the FDA Milestone Date.

  • Each Stock Award granted to a Participant shall be unvested on the date of grant and shall vest in four (4) equal tranches on the first, second, third and fourth anniversaries of the FDA Milestone Date (each, a “Vesting Date”), provided that the Participant does not incur a Termination of Employment (as defined in the Equity Incentive Plan) through the applicable Vesting Date.

  • The actual Awards earned by each Participant shall be determined by multiplying (x) the applicable percentage in the Payout Matrix based on the FDA Milestone Date by (y) the Participant’s Target Award Values for such Participant’s Cash Award and/or Stock Award (as applicable) to arrive at an “Actual Award Value” for such Cash Award and/or Stock Award.

  • The number of shares underlying the Stock Award will be determined by dividing (a) the Actual Award Value for such Stock Award by (b) the closing price of the Common Stock on the trading day immediately prior to the FDA Milestone Date.

  • Subject to Section 4(e) of the Plan, payment of the FDA Portions and EU Portions of Cash Awards to Participants shall be made as soon as administratively practicable following the applicable Certification Date, and no later than March 15 of the year following the year in which the FDA Milestone Date or EU Milestone Date, respectively, occurs.

  • In the event that the Company’s stockholders do not approve such an amendment to the Equity Incentive Plan prior to the FDA Milestone Date, then no Stock Awards shall be issued to Covered Employees pursuant to the Plan.

  • All Stock Awards issued to Participants on the Payout Date shall be unvested, and shall fully vest on the second (2nd) anniversary of the FDA Milestone Date (the “Vesting Date”), subject to continued employment with the Company through such date.

  • Subject to Section 4(d) of the Plan, payment of Cash Awards to Participants shall be made as soon as administratively practicable following the Certification Date, and no later than March 15 of the year following the year in which the FDA Milestone Date occurs; provided, however, that if payment of a Cash Award is accelerated pursuant to Section 8 of the Plan, then with respect to such Cash Award, such accelerated payment date shall be the “Payout Date” for purposes of the Plan.

  • The FDA Portion of a Stock Award shall fully vest on the second anniversary of the FDA Milestone Date, provided that the Participant does not incur a Termination of Employment (as defined in the Equity Incentive Plan) through the applicable Vesting Date.

Related to FDA Milestone Date

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

  • 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.

  • Development Milestone Event shall have the meaning set forth in Section 9.2(a).

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

  • Milestone means an event or task described in the Implementation Plan which must be completed by the corresponding date set out in such plan;

  • Sales Milestone Payment shall have the meaning set forth in Section 8.4.

  • Performance Milestone means an act or event specified in section 5.1 and described in section 9 of the EPLA.

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

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

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

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

  • 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;

  • 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.

  • 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).

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

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

  • KPI Target means the acceptable performance level for a KPI as set out in each KPI;

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

  • EBITDA Target means the Company's projected earnings before interest, taxes, one-time transition expenses, non-cash compensation expense charges, depreciation and amortization, as contained in the Company's budget for the Applicable Period and which is approved by the Board (without reference to any adjustments or revision, upwards or downwards, to such projected earnings which are subsequently approved by the Board as part of any subsequent revision to such budget), and (ii) the term "Financial Results" shall mean the Company's EBITDA calculated by reference to the Company's financial statements for the Applicable Period as filed with the Securities and Exchange Commission (the "SEC").

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • FDA Approval means with respect to the Product, a Regulatory Approval by the FDA for the commercial use of the Product in the United States.