IND Clearance Date definition

IND Clearance Date means, with respect to any IND, the date on which the sponsor of such IND is permitted to initiate clinical trials following submission of such IND to the applicable Regulatory Authority.
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IND Clearance Date shall have the meaning set forth in Section 3.1(a).
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IND Clearance Date means the earlier of (a) receipt of an IND clearance letter from the FDA with respect to any IND for a Licensed Product or (b) provided there is no clinical hold in effect, [***] days after the date of submission of any IND for a Licensed Product.
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Examples of IND Clearance Date in a sentence

  • In the event that the IND Clearance Date has not occurred prior to January 30, 2017, thirteen [***] Portions of this exhibit have been redacted pursuant to a confidential treatment request.

  • In addition, within 15 days following the IND Clearance Date, Cypress shall pay Xxxxxx Xxxxx $750,000 (Xxxxxx Xxxxx acknowledges that is has received such payment).

  • Participate in weekly/bi-weekly staff meetings with internal planning team to review progress and outcomes.

  • A Knowledge of the pattern of Sex Ratio* helps to explain the employment and consumption pattern, social needs of the people and perhaps the psychological characteristics of a community”.


More Definitions of IND Clearance Date

IND Clearance Date means January 2, 2002.
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IND Clearance Date means, with respect to an IND for a Licensed Product that was filed by Licensee, or any Affiliate or Sublicensee of Licensee, (a) in the U.S., the date that is [***] days following the filing of the first IND for such Licensed Product, if Licensee or its Affiliates or Sublicensees has not received any notice of a clinical hold or any other administrative delay from the FDA during such [***] day period; provided that, if Licensee or its Affiliate or Sublicensee does receive a notice of a clinical hold or there is such other administrative delay, then “IND Clearance Date” for such Licensed Product will be the date on which the FDA lifts such clinical hold or such other administrative delay is otherwise resolved and the FDA first allows the Licensed Product to be administered to a human pursuant to such IND, or (b) in other regulatory jurisdictions outside the U.S., the date on which such Licensed Product is first permitted by the applicable Regulatory Authority of such jurisdiction to be administered to a human pursuant to an IND in accordance with Applicable Law.
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Related to IND Clearance Date

  • HSR Clearance Date means the expiration or termination of all applicable waiting periods and requests for information (and any extensions thereof) under the HSR Act.

  • HSR Clearance means, as pertaining to this Agreement, the expiration or termination of all applicable waiting periods and requests for information (and any extensions thereof) under the HSR Act.

  • CFIUS Clearance means that any of the following shall have occurred: (i) the 45 day review period under the DPA commencing on the date that the CFIUS Notice is accepted by CFIUS shall have expired and the parties shall have received written notice from CFIUS that such review has been concluded and that either the Transaction does not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns; (ii) an investigation shall have been commenced after such 45 day review period and CFIUS shall have determined to conclude all deliberative action under the DPA without sending a report to the President of the United States, and the parties shall have received written notice from CFIUS that either the Transaction does not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Transaction; or (iii) CFIUS shall have sent a report to the President of the United States requesting the President’s decision and either (A) the period under the DPA during which the President may announce his decision to take action to suspend, prohibit or place any limitations on the Transaction shall have expired without any such action being threatened, announced or taken or (B) the President shall have announced a decision not to take any action to suspend, prohibit or place any limitations on the Transaction.

  • Medical clearance means a physician or other health care

  • Investment End Date : means 11 November 2022, or if such day is not a Scheduled Trading Day, the following day which is a Scheduled Trading Day.

  • Notification Date means 30 days from an Account statement date (see section 6.3).

  • Final Distribution Date The Distribution Date on which the final distribution in respect of the Certificates is made pursuant to Section 9.01.

  • Security Clearance means that level of security clearance required by the City or its police department for Contractor personnel accessing the information or premises required to be accessed in order to perform the Work under this Contract;

  • Interim Distribution Date means the date as soon as reasonably practicable after the Plan Implementation Date;

  • Assumed Final Distribution Date The Distribution Date occurring in November 2035.

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

  • Clearance System means the principal domestic clearance system customarily used for settling trades with respect to the Underlying as determined by the Calculation Agent acting in accordance with relevant market practice and in good faith.

  • Notification Time means 11:00 a.m., New York time, on a Local Business Day.

  • Escrow End Date has the meaning specified in the Escrow Agreement.

  • Drop Dead Date has the meaning set forth in Section 9.01(b)(i).

  • Required Date means the date given a Registered Entity in a notice from the Compliance Enforcement Authority by which some action by the Registered Entity is required.

  • Clearance System Business Day means, with respect to the Clearance System, any day (other than a Saturday or Sunday) on which the Clearance System is open for the acceptance and execution of settlement instructions.

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

  • Notification Period has the meaning given to such term in Clause 3.10(b) or 3.10(c) of the Gold Bullion Terms, as the case may be.

  • Parent Intervening Event means any event, change, occurrence or development that is unknown and not reasonably foreseeable to the Parent Board as of the date of this Agreement, or if known or reasonably foreseeable to the Parent Board as of the date of this Agreement, the material consequences of which were not known or reasonably foreseeable to the Parent Board as of the date of this Agreement; provided, that the receipt, existence or terms of a Parent Alternative Proposal shall not be deemed to be a Parent Intervening Event hereunder.

  • Relevant Distribution Date With respect to (a) any Significant Obligor with respect to the Trust, the Distribution Date, and (b) any Significant Obligor with respect to an Other Securitization Trust, the “Distribution Date” (or an analogous concept) under the related Other Pooling and Servicing Agreement.