FDA Event definition

FDA Event means the date on which Borrower has provided Bank with evidence, in Bank’s sole but reasonable discretion, that Borrower has received FDA approval of VP-102 for the treatment of Molluscum Contagiosum.”
Sample 1
FDA Event means the occurrence of any of the following events on or prior to March 31, 2011 (the “FDA Outside Date”): (a) the issuance by a court or other Governmental Authority of competent jurisdiction of an injunction or similar relief (“Injunctive Relief”) against the Company that affects the manufacture or sale of any products by or on behalf of the Company or the business or operations of the Company; (b) the FDA or any other Governmental Authority shall (i) seize any products manufactured or sold by or on behalf of the Company, or (ii) place any prohibition or limitation on the Company’s ability to import, export, ship or sell any products manufactured or sold by or on behalf of the Company (the matters referred to in clauses (i) and (ii), being referred to herein as “Product Relief”); or (c) the FDA or any other Governmental Authority shall threaten to take any of the actions specified in the immediately preceding clause (a) or (b), and as result thereof or in connection therewith, the Company and the FDA or such other Governmental Authority, as the case may be, shall enter into a consent decree or similar agreement that affects the manufacture or sale of any products by or on behalf of the Company or the business or operations of the Company (a “Consent Decree”); provided, however, that an FDA Event shall only be deemed to have occurred pursuant to the immediately preceding clauses (a), (b) or (c) if the issuance of the Injunctive Relief, the granting of the Product Relief or the execution of the Consent Decree, as applicable, arises out of or results from the inspection and audit of the Company that was commenced by the FDA on October 13, 2010 (the “Current FDA Audit”), it being understood and agreed that, for all purposes of this Agreement, the Current FDA Audit shall include any and all inspections or audits of the Company by the FDA that are undertaken on or prior to the FDA Outside Date as follow-up to, or to confirm compliance by the Company with the findings, requests and recommendations of the FDA issued in connection with, the inspection and audit of the Company that was commenced by the FDA on October 13, 2010; provided further, however, that if on or before the FDA Outside Date, the FDA or any other Governmental Authority shall commence any action or proceeding seeking, or shall threaten in writing to seek, any Enforcement Action, then the FDA Outside Date shall be extended until the earlier of (1) in the event any such action or proceeding has b...
Sample 1

Examples of FDA Event in a sentence

  • The significant unobservable input used in the fair value measurement of the forfeiture right is the fair value per share of the underlying common shares that were subject to forfeit upon the occurrence of the FDA Event of certain products acquired from NuTech Medical.

  • For purposes hereof, the term "FDA Event" shall mean the occurrence of either of the following events: (A) receipt from the United States Food and Drug Administration (or any successor thereto) of 510K approval of the Corporation's ViewMate(TM) Ultrasound Imaging System device, or (B) receipt from the United States Food and Drug Administration of pre-market approval of the Corporation's ALERT(R) System device, in each case for the marketing and sale of such devices in the United States.

  • The Corporation shall have the right, at its option, at any time and from time to time, from and after the date of an FDA Event to require the conversion, upon at least twenty (20) days' prior written notice to the holder but without the payment of additional consideration, of outstanding shares of Series A Preferred Stock into an equal number of fully paid and nonassessable shares of Common Stock.

  • The AAMI depiction of a closed-loop91 FDA Event Problem Codes were developed the FDA Center for Devices and Radiological Health, in cooperation with the National Cancer Institute Enterprise Vocabulary Service.

  • The fair value of the forfeiture right asset was determined by considering as inputs the type and probability of occurrence of FDA Event, the number of common shares to be forfeited, which is subject to negotiation, and the fair value per share of its common shares, by completing a third-party valuation of its common shares.

Related to FDA Event

  • 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.

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

  • €STR Index Cessation Event means the occurrence of one or more of the following events, as determined by the Issuer and notified by the Issuer to the Calculation Agent:

  • SOFR Index Cessation Event means the occurrence of one or more of the following events:

  • Index Cessation Event means an Index Cessation Event as defined in Supplement number 70 to the 2006 ISDA Definitions, as amended or supplemented from time to time, and, for the purposes of these Conditions and the definition of "Index Cessation Event" therein, the "Applicable Rate" as used therein is six-month Sterling LIBOR;

  • Regulatory Event means, following the occurrence of a Change in Law (as defined below) with respect to the Issuer and/or Société Générale as Guarantor or in any other capacity (including without limitation as hedging counterparty of the Issuer, market maker of the Certificates or direct or indirect shareholder or sponsor of the Issuer) or any of its affiliates involved in the issuer of the Certificates (hereafter the “Relevant Affiliates” and each of the Issuer, Société Générale and the Relevant Affiliates, a “Relevant Entity”) that, after the Certificates have been issued, (i) any Relevant Entity would incur a materially increased (as compared with circumstances existing prior to such event) amount of tax, duty, liability, penalty, expense, fee, cost or regulatory capital charge however defined or collateral requirements for performing its obligations under the Certificates or hedging the Issuer’s obligations under the Certificates, including, without limitation, due to clearing requirements of, or the absence of, clearing of the transactions entered into in connection with the issue of, or hedging the Issuer’sobligation under, the Certificates, (ii) it is or will become for any Relevant Entity impracticable, impossible (in each case, after using commercially reasonable efforts), unlawful, illegal or otherwise prohibited or contrary, in whole or in part, under any law, regulation, rule, judgement, order or directive of any governmental, administrative or judicial authority, or power, applicable to such Relevant Entity (a) to hold, acquire, issue, reissue, substitute, maintain, settle, or as the case may be, guarantee, the Certificates, (b) to acquire, hold, sponsor or dispose of any asset(s) (or any interest thereof) of any other transaction(s) such Relevant Entity may use in connection with the issue of the Certificates or to hedge the Issuer’s obligations under the Certificates, (c) to perform obligations in connection with, the Certificates or any contractual arrangement entered into between the Issuer and Société Générale or any Relevant Affiliate (including without limitation to hedge the Issuer’s obligations under the Certificates) or(d) to hold, acquire, maintain, increase, substitute or redeem all or a substantial part of its direct or indirect shareholding in the Issuer’s capital or the capital of any Relevant Affiliate or to directly or indirectly sponsor the Issuer or any Relevant Affiliate, or (iii) there is or may be a material adverse effect on a Relevant Entity in connection with the issue of the Certificates.

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

  • OBFR Index Cessation Event means the occurrence of one or more of the following events:

  • Notification Event means (a) the occurrence of a “reportable event” described in Section 4043 of ERISA for which the 30-day notice requirement has not been waived by applicable regulations issued by the PBGC, (b) the withdrawal of any Loan Party or ERISA Affiliate from a Pension Plan during a plan year in which it was a “substantial employer” as defined in Section 4001(a)(2) of ERISA, (c) the termination of a Pension Plan, the filing of a notice of intent to terminate a Pension Plan or the treatment of a Pension Plan amendment as a termination, under Section 4041 of ERISA, if the plan assets are not sufficient to pay all plan liabilities, (d) the institution of proceedings to terminate, or the appointment of a trustee with respect to, any Pension Plan by the PBGC or any Pension Plan or Multiemployer Plan administrator, (e) any other event or condition that would constitute grounds under Section 4042(a) of ERISA for the termination of, or the appointment of a trustee to administer, any Pension Plan, (f) the imposition of a Lien pursuant to the IRC or ERISA in connection with any Employee Benefit Plan or the existence of any facts or circumstances that could reasonably be expected to result in the imposition of a Lien, (g) the partial or complete withdrawal of any Loan Party or ERISA Affiliate from a Multiemployer Plan (other than any withdrawal that would not constitute an Event of Default under Section 8.12), (h) any event or condition that results in the reorganization or insolvency of a Multiemployer Plan under Sections of ERISA, (i) any event or condition that results in the termination of a Multiemployer Plan under Section 4041A of ERISA or the institution by the PBGC of proceedings to terminate or to appoint a trustee to administer a Multiemployer Plan under ERISA, (j) any Pension Plan being in “at risk status” within the meaning of IRC Section 430(i), (k) any Multiemployer Plan being in “endangered status” or “critical status” within the meaning of IRC Section 432(b) or the determination that any Multiemployer Plan is or is expected to be insolvent or in reorganization within the meaning of Title IV of ERISA, (l) with respect to any Pension Plan, any Loan Party or ERISA Affiliate incurring a substantial cessation of operations within the meaning of ERISA Section 4062(e), (m) an “accumulated funding deficiency” within the meaning of the IRC or ERISA (including Section 412 of the IRC or Section 302 of ERISA) or the failure of any Pension Plan or Multiemployer Plan to meet the minimum funding standards within the meaning of the IRC or ERISA (including Section 412 of the IRC or Section 302 of ERISA), in each case, whether or not waived, (n) the filing of an application for a waiver of the minimum funding standards within the meaning of the IRC or ERISA (including Section 412 of the IRC or Section 302 of ERISA) with respect to any Pension Plan or Multiemployer Plan, (o) the failure to make by its due date a required payment or contribution with respect to any Pension Plan or Multiemployer Plan, (p) any event that results in or could reasonably be expected to result in a liability by a Loan Party pursuant to Title I of ERISA or the excise tax provisions of the IRC relating to Employee Benefit Plans or any event that results in or could reasonably be expected to result in a liability to any Loan Party or ERISA Affiliate pursuant to Title IV of ERISA or Section 401(a)(29) of the IRC, or (q) any of the foregoing is reasonably likely to occur in the following 30 days.

  • 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.

  • Application Event means the occurrence of (a) a failure by Borrowers to repay all of the Obligations in full on the Maturity Date, or (b) an Event of Default and the election by Agent or the Required Lenders to require that payments and proceeds of Collateral be applied pursuant to Section 2.4(b)(iii) of this Agreement.

  • 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.

  • Potential Termination Event means an event which but for the lapse of time or the giving of notice, or both, would constitute a Termination Event.

  • Specified Event has the meaning given to such term in the definition of “Consolidated EBITDA.”

  • Relief Event means any of the following:

  • Incipient Event of Termination means an event that but for notice or lapse of time or both would constitute an Event of Termination.

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

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

  • Acquisition Event means a merger or consolidation in which the Company is not the surviving entity, any transaction that results in the acquisition of all or substantially all of the Company’s outstanding Common Stock by a single person or entity or by a group of persons and/or entities acting in concert, or the sale or transfer of all or substantially all of the Company’s assets.

  • Put Event means the occurrence of any of the following:

  • 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.

  • Book-Up Event means an event that triggers a positive adjustment to the Capital Accounts of the Partners pursuant to Section 5.5(d).

  • Event shall have the meaning set forth in Section 2(d).

  • Specified Cause Event shall have the meaning set forth in the SLDs.

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

  • Company Termination Event means any of the following: