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 means January 2, 2002.
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IND Clearance Date shall have the meaning set forth in Section 3.1(a).
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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 million two hundred and fifty thousand dollars ($13,250,000) of the upfront fee paid under Section 8.1 shall be creditable towards clinical and sales milestones that are or become due under the Platform Agreement.

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

  • In addition, within 15 days following the IND Clearance Date, Cypress shall pay ▇▇▇▇▇▇ ▇▇▇▇▇ [...***...

  • Notwithstanding the above, CELGENE shall be deemed to have exercised the CELGENE Worldwide Rights Option upon the Second IND Clearance Date, in which case CELGENE shall notify SUTRO promptly after such filing, and shall pay the applicable Option Exercise Fee within five (5) Business Days following filing.

  • I▇ ▇▇▇▇▇▇▇▇, within 15 days following the IND Clearance Date, Cypress shall pay Pierre Fabre $750,000.


More Definitions of IND Clearance Date

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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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 earliest date on which the Parties have actual knowledge that all applicable waiting periods under the HSR Act with respect to the transactions contemplated hereunder have expired or have been terminated.

  • HSR Clearance means either (a) early termination of the applicable waiting period under the HSR Act with respect to the HSR Filings or (b) expiration of the applicable waiting period under the HSR Act with respect to the HSR Filings.

  • CFIUS Clearance means any of the following: (a) if a joint voluntary notification is submitted to CFIUS that (i) the parties hereto shall have received written notice from CFIUS that it has concluded its review, or, if applicable, investigation of the transactions contemplated by this Agreement, and has determined that there are no unresolved national security concerns with respect to the transactions contemplated by this Agreement and that action under the DPA is concluded; or (ii) the parties hereto shall have received written notice from CFIUS that the transactions contemplated by this Agreement do not constitute a Covered Transaction (as such term is defined in 31 C.F.R. §800.213); (b) if CFIUS has sent a report to the President requesting the President’s decision with respect to the transactions contemplated by this Agreement, that either (i) the President has announced a decision not to take any action to suspend, prohibit or place any limitations on the transactions contemplated by this Agreement or (ii) the time permitted under the DPA for the President to take action to suspend or prohibit the transactions contemplated by this Agreement shall have lapsed without any such action being threatened, announced or taken; or (c) if a declaration is submitted to CFIUS pursuant to 31 C.F.R. §800.402, that the parties hereto shall have received written notice from CFIUS that (i) CFIUS has concluded its assessment of the transactions contemplated by this Agreement and determined there are no unresolved national security concerns related thereto, or (ii) CFIUS is not able to conclude its assessment of the transactions contemplated by this Agreement but CFIUS has not requested that the parties hereto submit a joint voluntary notice to CFIUS in connection thereto or initiated a unilateral review thereof.

  • 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.