Post-Approval Failure definition

Post-Approval Failure means: (a) a mandatory withdrawal or recall of a Product by a Regulatory Authority, or (b) any voluntary withdrawal or recall of a Product that arises from risks associated with a serious adverse health consequence or death reported to a Regulatory Authority anywhere in the world. Notwithstanding the foregoing, any such recall that results primarily from Licensee’s or its Affiliate’s or Sublicensee’s gross negligence, willful misconduct, or failure to comply with Applicable Law in the Development, Manufacture or Commercialization of a Product in the Territory shall not be considered a Post-Approval Failure for purposes of this Agreement.
Sample 1Sample 2Sample 3
Post-Approval Failure means: (a) a mandatory withdrawal or recall of a Product by a Regulatory Authority, or (b) any voluntary withdrawal or recall of a Product in a Major Ex-U.S. Market country that arises from risks associated with a serious adverse health consequence or death reported to a Regulatory Authority anywhere in the Territory. Notwithstanding the foregoing, any such recall that results primarily from Licensee’s or its Affiliate’s or Sublicensee’s gross negligence, willful misconduct, or failure to comply with Applicable Law in the Development, Manufacture or Commercialization of a Product in the Territory shall not be considered a Post-Approval Failure for purposes of this Agreement.
Sample 1Sample 2
Post-Approval Failure means: (a) a mandatory withdrawal or recall of a Product by a Regulatory Authority, or (b) any voluntary
Sample 1

Examples of Post-Approval Failure in a sentence

  • If a Post-Approval Failure occurs anywhere in the Territory, Licensee may, at its option, terminate the Agreement either in its entirety, or in the country where the Post-Termination Failure occurred only, or on a country-by-country basis with respect to one or more countries of the Territory; provided, that written notice of termination must be delivered to POZEN within *** (***) days following such Post-Approval Failure.

  • Davis and Steinbock (2014), with reference to the work of Max Scheler, argue that the subjective (which includes the affective or emotional) inevitably precedes all acts of reasoning (Davis and Steinbock, 2014).

  • Sinclair Community College holds a Federalwide Assurance (FWA) through OHRP.

  • If a Post-Approval Failure occurs in the Territory, Licensee may, at its option, terminate the Agreement in its entirety; provided, that written notice of termination must be delivered to POZEN within sixty (60) days following such Post-Approval Failure.

Related to Post-Approval Failure

  • 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;

  • 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.

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

  • 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);

  • 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.

  • 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.

  • 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.

  • 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)

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

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

  • Listing Failure Event means that:

  • 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.

  • 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.

  • 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.

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

  • 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;

  • 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.

  • 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).

  • Pre-approval means written notification via a pre-approval letter to Customer that Ameren Illinois has reviewed Customer's Application and determined that the project meets the program eligibility requirements for a maximum pre-approved incentive amount if the project is completed by the estimated completion date and all final application paperwork is submitted and approved.

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • Preliminary Approval Date means the date the Preliminary Approval Order is entered by the Court.

  • Completion Deadline means August 15, 2018, or such later date as may be agreed to in writing by the Parties;

  • Milestone Event has the meaning set forth in Section 8.4.

  • 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.

  • Consistent Failure means any of: