Unanticipated Adverse Device Effects (UADE) Sample Clauses

Unanticipated Adverse Device Effects (UADE). An Unanticipated Adverse Device Effect (UADE) is a serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect or problem was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects. Anticipated potential adverse device effects have been identified in the sponsor Risk Management files and/or product labeling. The Principal Investigator will assure that all unanticipated adverse device effect (UADE) involving risk to subjects or others will be reported to the sponsor within 24 hours of knowledge of event. All UADE’s will be evaluated and the results of such evaluation will be reported to the IRB within ten (10) working days after the event is reported by the study subjects. The sponsor will report all SAE’s and UADE’s to the appropriate regulatory authority. All Serious and Unanticipated Adverse Effects will be reviewed by a Medical Monitor.
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Related to Unanticipated Adverse Device Effects (UADE)

  • Litigation; Adverse Effects (a) To the best of Borrower’s knowledge, there is no Proceeding, pending or threatened, against Borrower or any property of Borrower (including the Property), which, if adversely determined, would result in a Material Adverse Effect. (b) Except as disclosed on Schedule 5.11 hereto, Borrower is not (i) in violation of any applicable law, which violation has a Material Adverse Effect, or (ii) subject to or in default with respect to any Court Order which has a Material Adverse Effect.

  • No Adverse Events Between the date hereof and the Closing Date, neither the business, assets or condition, financial or otherwise, of the Company taken as a whole shall have been materially adversely affected in any manner.

  • No Material Adverse Event Since the respective dates as of which information is disclosed in the Registration Statement, the Prospectus and the Incorporated Documents, except as otherwise stated therein, there shall not have been (i) any change or decrease in previously reported results specified in the letter or letters referred to in paragraph (d) of this Section 6 or (ii) any change, or any development involving a prospective change, in or affecting the condition (financial or otherwise), earnings, business or properties of the Company and its subsidiaries taken as a whole, whether or not arising from transactions in the ordinary course of business, except as set forth in or contemplated in the Registration Statement, the Prospectus and the Incorporated Documents (exclusive of any amendment or supplement thereto) the effect of which, in any case referred to in clause (i) or (ii) above, is, in the sole judgment of the Manager, so material and adverse as to make it impractical or inadvisable to proceed with the offering or delivery of the Shares as contemplated by the Registration Statement (exclusive of any amendment thereof), the Incorporated Documents and the Prospectus (exclusive of any amendment or supplement thereto).

  • Company Material Adverse Effect Since the date of this Agreement, there shall not have been any Company Material Adverse Effect or any event, change, or effect that would, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect.

  • No Material Adverse Change or Ratings Agency Change For the period from and after the date of this Agreement and through and including the First Closing Date and, with respect to any Optional Shares purchased after the First Closing Date, each Option Closing Date: (i) in the judgment of the Representatives there shall not have occurred any Material Adverse Change; and (ii) there shall not have occurred any downgrading, nor shall any notice have been given of any intended or potential downgrading or of any review for a possible change that does not indicate the direction of the possible change, in the rating accorded any securities of the Company or any of its subsidiaries by any “nationally recognized statistical rating organization” as that term is used in Rule 15c3-1(c)(2)(vi)(F) under the Exchange Act.

  • Notice of Material Adverse Effect The Company shall notify the Buyer (and any subsequent holder of the Debentures), as soon as practicable and in no event later than three (3) business days of the Company’s knowledge of any Material Adverse Effect on the Company. For purposes of the foregoing, “knowledge” means the earlier of the Company’s actual knowledge or the Company’s constructive knowledge upon due inquiry.

  • Notice of Material Adverse Change Firm agrees to notify Citizens in writing of any “Material Adverse Change” to Firm within ten (10) days of said change. A “Material Adverse Change” means: (i) a change in the business operations or financial condition of Firm which negatively impacts its capacity to meet its professional or financial obligations;

  • Litigation; Adverse Facts There are no actions, suits, proceedings, arbitrations or governmental investigations (whether or not purportedly on behalf of Holdings or any of its Subsidiaries) at law or in equity, or before or by any federal, state, municipal or other governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign (including any Environmental Claims) that are pending or, to the knowledge of Holdings or Company, threatened against or affecting Holdings or any of its Subsidiaries or any property of Holdings or any of its Subsidiaries and that, individually or in the aggregate, would reasonably be expected to result in a Material Adverse Effect. Neither Holdings nor any of its Subsidiaries (i) is in violation of any applicable laws (including Environmental Laws) that, individually or in the aggregate, would reasonably be expected to result in a Material Adverse Effect, or (ii) is subject to or in default with respect to any final judgments, writs, injunctions, decrees, rules or regulations of any court or any federal, state, municipal or other governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, that, individually or in the aggregate, would reasonably be expected to result in a Material Adverse Effect.

  • Professional Development; Adverse Consequences of School Exclusion; Student Behavior The Board President or Superintendent, or their designees, will make reasonable efforts to provide ongoing professional development to Board members about the adverse consequences of school exclusion and justice-system involvement, effective classroom management strategies, culturally responsive discipline, appropriate and available supportive services for the promotion of student attendance and engagement, and developmentally appropriate disciplinary methods that promote positive and healthy school climates, i.e., Senate Bill 100 training topics. The Board will conduct periodic self-evaluations with the goal of continuous improvement. New Board Member Orientation The orientation process for newly elected or appointed Board members includes:

  • Absence of Material Adverse Change On the Closing Date, no circumstance shall exist that constitutes a REIT II Material Adverse Effect.

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