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.
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.
IND Clearance Date shall have the meaning set forth in Section 3.1(a).

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 these cases, the client must assume all the expenses incurred.

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

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

  • 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.


More Definitions of IND Clearance Date

IND Clearance Date means January 2, 2002.
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.

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 under this Agreement 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 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 Contemplated Transactions do 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 Contemplated Transactions do 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 Contemplated Transactions; 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 Contemplated Transactions 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 Contemplated Transactions.

  • 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).

  • 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;

  • 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 1:00 p.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 by the 10th Business Day following the end of the Quarter for which the information prescribed in Annex V4 is being provided.

  • 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 upon which Final Approval occurs.

  • Notification Period means a set period of time between the submittal of a Notice of Intent and the beginning of lead - based paint abatement activities (including all on-site worksite preparation).

  • Required Holding Period means the requisite period prescribed by the ITO and the Rules, or such other period as may be required by the ITA, with respect to 102 Trustee Grants, during which Awards granted by the Company must be held by the Trustee for the benefit of the person to whom it was granted. As of the date of the adoption of this Sub-Plan, the Required Holding Period for 102 Capital Gains Track Grants is 24 months from the date of grant of the Award.

  • Qualification Deadline has the meaning set forth in Section 2(a)(ii).

  • Certification Date means the later of the date on which an order granting certification or authorization of a Proceeding against one or more Non-Settling Defendants is issued by a Court and the time to appeal such certification or authorization has expired without any appeal being taken, or if an appeal is taken the date of the final disposition of such appeal.

  • Collateral Quality Test means a test that is satisfied if, as of any date of determination, in the aggregate, the Collateral Loans owned (or in relation to a proposed acquisition of a Collateral Loan, both owned and proposed to be owned) by the Borrower satisfy each of the tests set forth below, calculated in each case in accordance with Section 1.3:

  • Application Approval Date means the date that the Application is approved by the Board of Trustees of the District and as further identified in Section 2.3.B of this Agreement.

  • Waiting Period shall have the meaning set forth in Section 2.2.

  • Agreement End Date has the meaning specified in Section 10.1(e).

  • Collateral Quality Tests means the Collateral Quality Tests set out in the Investment Management Agreement being each of the following:

  • Qualifying exigency means a situation where the eligible employee seeks leave for one or more of the following reasons:

  • Initial compliance period means the three-year compliance period that begins January 1, 1993, except for the MCLs for dichloromethane, 1,2,4-trichlorobenzene, 1,1,2-trichloroethane, benzo(a)pyrene, dalapon, di(2-ethylhexyl)adipate, di(2-ethyl- hexyl)phthalate, dinoseb, diquat, endothall, endrin, glyphosate, hexachlorobenzene, hexachlorocyclopentadiene, oxamyl, picloram, simazine, 2,3,7,8-TCDD, antimony, beryllium, cyanide, nickel, and thallium, as they apply to a supplier whose system has fewer than 150 service connections, for which it means the three-year compliance period that began on January 1, 1996.