Remedial Event definition

Remedial Event means an event whereby Product is subject to a recall, field corrective action, or other regulatory action, including a clinical hold.
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Examples of Remedial Event in a sentence

  • In the event of a Remedial Event the Parties agree that Company’s obligation to supply and LBIO’s obligation to purchase any Batches included in the Forecast that would be affected by such Remedial Event, shall be suspended commencing upon receipt by Company of written notice from LBIO of the Remedial Event and continuing until such time as such Remedial Event is resolved.

  • LBIO shall promptly notify Company when any such Remedial Event is resolved and the Parties obligations which were suspended shall resume.

  • Regardless of any such suspension, LBIO shall remain obligated to pay for the manufacturing suite fees as specified in an applicable Statement of Work; provided, that, if an investigation conducted under the Quality Agreement determines that such Remedial Event was caused by the negligence or willful misconduct of Company, LBIO shall have no obligation to pay such fees during the period of suspension.

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  • Regardless of any such suspension, Iovance shall remain obligated to pay for the manufacturing suite fees as specified in an applicable Statement of Work; provided, that, if an investigation conducted under the Quality Agreement determines that such Remedial Event was caused by the negligence or willful misconduct of Company, Iovance shall have no obligation to pay such fees during the period of suspension.

Related to Remedial Event

  • Environmental Event shall have the meaning set forth in Section 12.2.1.

  • Material Event has the meaning set forth in Section 3(i) hereof.

  • Material Events means any of the events listed in Section 3 of this Continuing Disclosure Undertaking.

  • Potential Material Event means any of the following: (i) the possession by the Company of material information not ripe for disclosure in the Registration Statement, which shall be evidenced by determinations in good faith by the Board of Directors of the Company that disclosure of such information in the Registration Statement would be detrimental to the business and affairs of the Company, or (ii) any material engagement or activity by the Company which would, in the good faith determination of the Board of Directors of the Company, be adversely affected by disclosure in the Registration Statement at such time, which determination shall be accompanied by a good faith determination by the Board of Directors of the Company that the Registration Statement would be materially misleading absent the inclusion of such information.

  • Potential Event of Default means any event which, with the giving of notice or the lapse of time or both, would constitute an Event of Default.

  • Medical event means an event that meets the criteria in 12VAC5-481-2080.

  • Insured Environmental Event As defined in Section 3.07(d).

  • Material Event of Default means the occurrence of an Event of Default (as defined in the Senior Unsecured Loan Agreement) under any of the following sections of the Senior Unsecured Loan Agreement:

  • Removal Event has the meaning set forth in Section 12.12 hereof.

  • Special Event means any of a Tax Event, an Investment Company Event or a Capital Treatment Event.

  • Clean-Up Period has the meaning specified in Section 8.02(b).

  • ERISA Event means (a) any “reportable event”, as defined in Section 4043 of ERISA or the regulations issued thereunder with respect to a Plan (other than an event for which the 30-day notice period is waived); (b) the existence with respect to any Plan of an “accumulated funding deficiency” (as defined in Section 412 of the Code or Section 302 of ERISA), whether or not waived; (c) the filing pursuant to Section 412(d) of the Code or Section 303(d) of ERISA of an application for a waiver of the minimum funding standard with respect to any Plan; (d) the incurrence by the Borrower or any of its ERISA Affiliates of any liability under Title IV of ERISA with respect to the termination of any Plan; (e) the receipt by the Borrower or any ERISA Affiliate from the PBGC or a plan administrator of any notice relating to an intention to terminate any Plan or Plans or to appoint a trustee to administer any Plan; (f) the incurrence by the Borrower or any of its ERISA Affiliates of any liability with respect to the withdrawal or partial withdrawal from any Plan or Multiemployer Plan; or (g) the receipt by the Borrower or any ERISA Affiliate of any notice, or the receipt by any Multiemployer Plan from the Borrower or any ERISA Affiliate of any notice, concerning the imposition of Withdrawal Liability or a determination that a Multiemployer Plan is, or is expected to be, insolvent or in reorganization, within the meaning of Title IV of ERISA.

  • Terminating Event means any of the following events:

  • Emergency Event means any situation arising from sudden and reasonably unforeseen natural disaster such as earthquake, flood, fire, or other acts of God, or other unforeseen events beyond the control of drayage truck owners and operators that threatens public health and safety or the reasonable flow of goods movement.

  • Special event permit means a permit granted by the Division

  • Special Events means musical events, concerts, shows, pageants, sporting events, festivals, competitions, and other events of limited duration presented by LICENSEE for which the "Gross Revenue" of such Special Event exceeds $25,000.

  • Foreign Plan Event means, with respect to any Foreign Plan or Foreign Benefit Arrangement, (i) the failure to make or, if applicable, accrue in accordance with normal accounting practices, any employer or employee contributions required by applicable law or by the terms of such Foreign Plan or Foreign Benefit Arrangement; (ii) the failure to register or loss of good standing (if applicable) with applicable regulatory authorities of any such Foreign Plan or Foreign Benefit Arrangement required to be registered; or (iii) the failure of any Foreign Plan or Foreign Benefit Arrangement to comply with any provisions of applicable law and regulations or with the terms of such Foreign Plan or Foreign Benefit Arrangement.

  • Environmental Activity means any activity, event or circumstance in respect of a Contaminant, including, without limitation, its storage, use, holding, collection, purchase, accumulation, assessment, generation, manufacture, construction, processing, treatment, stabilization, disposition, handling or transportation, or its Release, escape, leaching, dispersal or migration into the natural environment, including the movement through or in the air, soil (land surface or subsurface strata), surface water or groundwater;

  • Remediation Period has the meaning specified in Section 8.2(a);

  • Withdrawal Event means the earliest to occur of any event which causes a Partner to cease to be a Partner, and to become a Former Partner, as set forth in Section 1.29.

  • Catastrophic Event means a rare circumstance in which mass casualties and/or significant property damage has occurred or is imminent (e.g. September 11th, hurricanes, earthquakes greater than 6.1 on the Richter scale)

  • ii) Event means any event described in Section 11(a)(ii) hereof.

  • ERISA Termination Event means (i) a “Reportable Event” described in Section 4043 of ERISA and the regulations issued thereunder (other than a “Reportable Event” not subject to the provision for 30-day notice to the PBGC under such regulations), or (ii) the withdrawal of a Borrower or any of its ERISA Affiliates from a “single employer” Plan during a plan year in which it was a “substantial employer”, both of such terms as defined in Section 4001(a) of ERISA, or (iii) the filing of a notice of intent to terminate a Plan or the treatment of a Plan amendment as a termination under Section 4041 of ERISA, or (iv) the institution of proceedings to terminate a Plan by the PBGC or (v) any other event or condition which might constitute grounds under Section 4042 of ERISA for the termination of, or the appointment of a trustee to administer, any Plan or (vi) the partial or complete withdrawal of a Borrower or any ERISA Affiliate of such Borrower from a “multiemployer plan” as defined in Section 4001(a) of ERISA.

  • Capital Event means and includes: (i) any transaction involving the sale, exchange or other disposition of the Project or the Company (but excluding any incidental sales or exchanges of tangible personal property and fixtures), (ii) any financing, refinancing or borrowing secured by the Project or the Company, and (iii) any condemnation or recovery of damage awards and property insurance proceeds (excluding proceeds from any rent or business interruption insurance).

  • 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.

  • Barrier Event means that R (final) is lower than the Barrier.