FDA Milestone Payment definition

FDA Milestone Payment has the meaning set forth in Section 4.2(a).
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FDA Milestone Payment has the meaning set forth in Section 3.9(c).
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FDA Milestone Payment has the meaning set forth in Section 4.2(a). --------------
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Examples of FDA Milestone Payment in a sentence

  • The parties hereto agree to issue separate individual press releases, each in a form approved by the other party, to announce the execution of this Agreement and the payment of the FDA Milestone Payment pursuant to Section 4.2(a).

  • On or prior to the thirtieth (30th) day following the achievement of the FDA Milestone, Buyer shall deliver to Seller the FDA Milestone Payment Amount; provided, however, that Buyer shall not be required to make, and Seller shall not be entitled to receive, the FDA Milestone Payment if the FDA Milestone is achieved after October 1, 2012.

  • Each of Buyer and Seller hereby acknowledge that the achievement of the FDA Milestone is uncertain and that Buyer and its Affiliates may not achieve the FDA Milestone prior to October 1, 2012 or at all, and it is therefore not assured that Buyer will be required to pay the FDA Milestone Payment at all.

  • Subject to the set-off rights of Buyer pursuant to Section 2.7(h) and Article 9 hereof, Buyer shall make a one-xxxx Xxxxxx Contingent Payment equal to the FDA Milestone Payment Amount if and only if the FDA Milestone is achieved on or before October 1, 2012 (the “FDA Milestone Payment”).

  • Any Holder that does not provide a Questionnaire to Parent by the Participation Deadline or return a new Election form by the Election Change Deadline, shall receive his, her or its respective share of the FDA Milestone Payment in accordance with such Holder’s original Election.

  • For the avoidance of doubt, no FDA Milestone Payment shall be payable if the Additional Investment Opt-In Right is not exercised in accordance with Section 2.3.

  • Each of Parent, the Company and the Equityholders’ Representative hereby acknowledge that the achievement of the FDA Milestone is uncertain and that Parent and its Affiliates may not achieve the FDA Milestone prior to the Contingent Payment Termination Date or at all, and it is therefore not assured that Parent will be required to pay the FDA Milestone Payment at all.

  • If the Buyer had already funded the Maximum Additional Investment Payment Amount prior to the Buyer’s receipt of notice of the occurrence of the FDA Milestone Event, then the Seller shall, within [ * ] Business Days of the occurrence of the FDA Milestone Event, pay the FDA Milestone Payment to the Buyer.

  • The parties hereto agree to issue separate individual press releases, each in a form approved by the other party, to announce the execution of this Agreement and the payment of the FDA Milestone Payment pursuant to S ection 4.2(a).

  • Subject only to the set-off rights of Parent and the Surviving Corporation pursuant to Section 1.8(j) and Article 9 hereof, and other rights of reduction specifically contemplated hereby, Parent and the Surviving Corporation shall, jointly and severally, make a Contingent Payment (the “FDA Milestone Payment”) equal to the FDA Milestone Payment Amount following achievement of the FDA Milestone.


More Definitions of FDA Milestone Payment

FDA Milestone Payment is defined in Section 2.3(a). “Final Order” means an order or judgment of the Bankruptcy Court (or any other court of competent jurisdiction) entered by the clerk of the Bankruptcy Court (or such other court) on the docket in the Chapter 11 Case (or the docket of such other court), which has not been modified, amended, reversed, vacated or stayed and as to which (i) the time to appeal, petition for certiorari, or move for a new trial, reargument or rehearing has expired and as to which no appeal, petition for certiorari or motion for new trial, reargument or rehearing shall then be pending or (ii) if an appeal, writ of certiorari new trial, reargument or rehearing thereof has been sought, such order or judgment of the Bankruptcy Court (or other court of competent jurisdiction) shall have been affirmed by the highest court to which such order was appealed, or certiorari shall have been denied, or a new trial, reargument or rehearing shall have been denied or resulted in no modification of such order, and the time to take any further appeal, petition for certiorari or move for a new trial, reargument or rehearing shall have expired, as a result of which such order shall have become final in accordance with Rule 8002 of the Federal Rules of Bankruptcy Procedure; provided, that the possibility that a motion under Rule 60 of the Federal Rules of Civil Procedure, or any analogous rule under the Bankruptcy Rules, may be filed relating to such order, shall not cause an order not to be a Final Order.
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FDA Milestone Payment means $2.00 per FDA CVR less, in the case of Accredited Unaffiliated Holders, each such Holder’s pro rata share of the Indemnification Amount, if any.
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FDA Milestone Payment means a payment equal to seventy-five percent (75%) of the Funded Amount at the time of such determination, less any EMA Milestone Payment previously paid to the Buyer pursuant to Section 5.12(a). For clarity, if the Buyer has paid the Maximum Additional Investment Payment Amount to the Seller at the time of the FDA Milestone Event, and the FDA Milestone Event occurs prior to the EMA Milestone Event, the FDA Milestone Payment shall equal $150,000,000 and no EMA Milestone Payment shall be payable under this Agreement.
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Related to FDA Milestone Payment

  • 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;

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

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

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

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

  • Milestone Event has the meaning set forth in Section 1.11(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 Payments means, collectively, the Development Milestone Payments and Sales Milestone Payments.

  • 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 has the meaning set forth in Section 7.2.1.

  • Development Milestone is defined in Section 5.3.

  • Milestone Date means the target date set out against the relevant Milestone in the Implementation Plan by which the Milestone must be Achieved;

  • Milestone Events has the meaning set forth in Section 7.2.

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

  • 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.

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

  • Project Milestones means the Project milestones set out in Schedule 3;

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

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

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

  • Sublicense Revenue means [***].

  • Royalty Payment has the meaning set forth in Section 6.1.

  • Sublicense Fees shall have the meaning set forth in Section 7.3 below.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • 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.

  • 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).