Approval Failure definition

Approval Failure means, in reference to a Licensed Product being Developed toward Regulatory Approval in any Major Market Country, an actual or probable final rejection of the Licensed Product for use in the Field from the Regulatory Authority for such Major Market Country.
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Approval Failure means a complete and final response letter from the FDA failing to grant Regulatory Approval of the first to be filed of either an ANDA or 505(b)(2) Application for the Licensed Product.
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Approval Failure has the meaning set forth in Section 3.03(e).
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Examples of Approval Failure in a sentence

  • Suspension or Revocation or Approval Failure to comply with any provision of this rule shall constitute grounds for suspension or revocation of the approval of a course, a provider or an instructor, or other such action as deemed appropriate by the Board.

  • Vardaro determined the garage permit would extend the nonconformity of the original structure over the rear yard and side yard setbacks, and the rear property line.

  • If a Gaming Approval Failure occurs, then this Agreement shall automatically terminate.

  • If a Gaming Approval Failure occurs, the HLV Repurchase Right shall automatically terminate and be deemed null and void.

  • If a Gaming Approval Failure occurs, the Put Right shall automatically terminate and be deemed null and void.

  • These offices can address issues relate to: Maintaining Status, SEVIS Reporting Requirements, Grace Periods, Program Extensions, Regulations for F-2 Dependents, Change of Address, Change of Major, Transfers, Reduced Course Load, Dropping To Part-Time Enrollment Without Prior Approval, Failure And Consequences To Maintain Status, Reinstatement, and Employment In F-1 Status.

  • In the event any Required Approval cannot be obtained during the period ending 45 days subsequent to the date of the filing of the registration statement (an "Approval Failure"), the Company's obligations to offer the Eligible Shares to the Eligible Members shall terminate and the Company shall have no further obligation or liability pursuant to this Section 6.

  • Failure to Obtain Advance Approval: Failure to obtain approval of the transfer of accreditation in advance of the change of control will result in the withdrawal of the school’s accreditation and removal of the school from the list of ACCSC-accredited schools as of the date that the change of control occurred.

  • Rescinding Approval Failure of the owner, operator or leaseholder of an approved wireless communications facility to renew or replace any required performance guarantee or insurance certificates, provide information to the Township about the facility as required by this Section, or maintain and operate the facility in compliance with the provisions of this Section shall be grounds for the Township to rescind any previous approval to construct or operate the facility.

  • Notwithstanding anything else in this Agreement, in the event of an Alkermes Approval Failure, Biogen shall have no obligation to Exploit (including, for clarity, to seek Regulatory Approval for) the Alkermes 8700 Product.


More Definitions of Approval Failure

Approval Failure where a review of a Documentary Deliverable is recorded as unsuccessful because the relevant Quality Criteria have not been met;
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Approval Failure has the meaning set forth in Section 1.4(b).
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Related to Approval Failure

  • GEP Failure means Seller’s failure to produce Delivered Energy in an amount equal to or greater than the Guaranteed Energy Production amount for the applicable Performance Measurement Period.

  • MI Failure means when an MI report: a) contains any material errors or material omissions or a missing mandatory field; or b) is submitted using an incorrect MI reporting Template; or c) is not submitted by the reporting date(including where a Nil Return should have been filed);

  • Supply Failure shall have the meaning ascribed to it in Section 2.8.

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

  • Listing Failure means the situation where the Bonds have not been listed on the corporate bond list of Nasdaq Stockholm (or any other Regulated Market) within sixty (60) calendar days after the Issue Date.

  • Listing Failure Event means that:

  • Technical Failure means the discontinuation of Development or Commercialization of a Product for technical, scientific, medical or regulatory reasons, including, but, not limited to, unacceptable preclinical toxicity, demonstration of a side effect profile significantly worse than currently marketed products, or inability to manufacture in an acceptable purity or for an acceptable price.

  • Price Failure means, with respect to a particular date of determination, the VWAP of the Common Stock on any Trading Day during the seven (7) Trading Day period ending on the Trading Day immediately preceding such date of determination fails to exceed the Floor Price (as adjusted for stock splits, stock dividends, stock combinations, recapitalizations or other similar transactions occurring after the date hereof). All such determinations to be appropriately adjusted for any stock splits, stock dividends, stock combinations, recapitalizations or other similar transactions during any such measuring period.

  • Transaction Failure means the failure to consummate a Business Combination within 18 months of the Effective Date (or 24 months after the Effective Date, if a letter of intent, agreement in principle or definitive agreement has been executed within 18 months after the Effective Date and the Business Combination relating thereto has not yet been consummated within such 18-month period).

  • Service Failure means a failure by the Contractor to provide the Services in accordance with any individual service level described above (measured on a monthly/quarterly/annual basis)

  • Reporting Failure has the meaning set forth in Section 2.4.

  • Volume Failure means, with respect to a particular date of determination, the aggregate daily dollar trading volume (as reported on Bloomberg) of the Common Stock on the Principal Market on any Trading Day during the twenty (20) Trading Day period ending on the Trading Day immediately preceding such date of determination (such period, the “Volume Failure Measuring Period”), is less than $2,000,000 (as adjusted for any stock splits, stock dividends, stock combinations, recapitalizations or other similar transactions occurring after the Subscription Date). All such determinations to be appropriately adjusted for any stock splits, stock dividends, stock combinations, recapitalizations or other similar transactions during such Volume Failure Measuring Period.

  • Persistent Failure means any two (2) or more failures by the Supplier in any rolling period of twelve (12) months to comply with obligations in respect of the Contract Services under the Contract;

  • Epidemic Failure means a series of repeating failures or defects resulting in at least a 0.5% failure rate for the same Product or Material during any twelve-month period.

  • Transaction Failure Date means the 18-month anniversary of the Effective Date (or the 24 month anniversary of the Effective Date, if a letter of intent, agreement in principle or definitive agreement has been executed within 18 months after the Effective Date and the Business Combination relating thereto has not yet been consummated within such 18-month period).

  • Non-Approval Event means, in respect of the Benchmark:

  • Consistent Failure means any of:

  • Service Level Failure means a failure to perform the Software Support Services fully in compliance with the Support Service Level Requirements.

  • 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.

  • Approval Date means the date on which the Plan is approved by the Company’s stockholders.

  • Equity Conditions Failure means that on any applicable date the Equity Conditions have not been satisfied (or waived in writing by the Holder).

  • Potential Failure to Pay means the failure by a Reference Entity to make, when and where due, any payments in an aggregate amount of not less than the Payment Requirement under one or more Obligations, without regard to any grace period or any conditions precedent to the commencement of any grace period applicable to such Obligations, in accordance with the terms of such Obligations at the time of such failure.

  • Notice Event means any of the events enumerated in paragraph (b)(5)(i)(C) of the Rule and listed in Section 4(a) of this Disclosure Agreement.

  • Force Majeure Failure has the meaning set forth in Section 8.1(d).

  • Approval Notice means, with respect to any Eligible Loan Asset, the written notice, in substantially the form attached hereto as Exhibit A, evidencing the approval by the Administrative Agent, in its sole discretion, of the conveyance of such Eligible Loan Asset by the Transferor to the Borrower pursuant to the terms of the Purchase and Sale Agreement and the Loan Assignment by which the Transferor effects such conveyance.

  • FDA Approval means the approval by the FDA of a premarket approval application to market and sell a Product, as evidenced by the publication of such approval by the FDA.