Definition of Adverse Event Sample Clauses

Definition of Adverse Event. Adverse event means any untoward medical occurrence associated with the use of an investigational product in humans, whether or not considered product-related. An adverse event (also referred to as an adverse experience) can be any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product and does not imply any judgment about causality. An adverse event can arise with any use of the investigational product (e.g. off-label use, use in combination with another product) and with any route of administration, formulation, or dose, including an overdose. Medical conditions that exist prior to administration of the study vaccine (pre-existing conditions) will be recorded in the participant’s medical history to establish baseline. Day-to-day fluctuations in pre-existing conditions that do not represent a clinically significant change in the participant’s status will not necessarily be reported as adverse events. Any adverse change from the participant’s baseline condition (determined from screening evaluations conducted to confirm study eligibility) that occurs following the administration of the study vaccine will be considered an adverse event. This includes the occurrence of a new adverse event or the worsening of a baseline condition, whether or not considered related to the study vaccine. Intermittent conditions such as headaches in adults or irritability in infants may be present on study Day 0 but may represent an adverse event if the intensity or duration of the event is worse than usual following receipt of study vaccine. Adverse events include but are not limited to: adverse changes from baseline that represent increases in severity, adverse changes in the general condition of the participant, signs and symptoms noted by the participant, concomitant disease with onset or increased severity after study vaccine administration, and clinically significant changes in laboratory safety parameters occurring after study vaccine administration.
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Definition of Adverse Event. Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom (including an AE occurring from drug abuse, an AE occurring from drug withdrawal and any failure of expected pharmacological action), or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. An elective surgery/procedure scheduled to occur during a study will not be considered an adverse event if the surgery/procedure is being performed for a pre-existing condition and the surgery/procedure has been pre-planned prior to study entry. However, if the pre-existing condition deteriorates unexpectedly during the study (e.g. surgery performed earlier than planned), then the deterioration of the condition for which the elective surgery/procedure is being done will be considered an adverse event.
Definition of Adverse Event. A "Serious Adverse Event" for the Product shall have the meaning set forth in 21 C.F.R. Section 314.80(a), as amended from time to time and a "Non-Serious Adverse Event" is defined as an untoward medical occurrence at any dose for the Product that is not a Serious Adverse Event.
Definition of Adverse Event. An AE is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, whether or not the event has a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. This definition includes intercurrent illnesses, accidents or injuries, exacerbations or preexisting conditions, changes on physical examination or physiological testing, abuse of drugs, or withdrawal reactions. [***] Severity Assessment [***] Confidential Information Protocol version 1.1, 21 Aug 2012 Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by [***]. Protocol XX-000-000 XX-000 Xxxxxxxxx Assessment [***]

Related to Definition of Adverse Event

  • Notification of Events of Default and Adverse Developments The Borrower shall promptly notify the Lender upon obtaining knowledge of the occurrence of:

  • Notice of Suits, Adverse Events Furnish Agent with prompt notice of (i) any lapse or other termination of any Consent issued to any Borrower by any Governmental Body or any other Person that is material to the operation of any Borrower's business, (ii) any refusal by any Governmental Body or any other Person to renew or extend any such Consent; and (iii) copies of any periodic or special reports filed by any Borrower with any Governmental Body or Person, if such reports indicate any material change in the business, operations, affairs or condition of any Borrower, or if copies thereof are requested by Lender, and (iv) copies of any material notices and other communications from any Governmental Body or Person which specifically relate to any Borrower.

  • 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.

  • Definition of Change of Control For purposes of this Agreement, a “Change of Control” will mean the first to occur of:

  • Definition of Change in Control For purposes of this Agreement, a “Change in Control” shall mean the occurrence of any of the following events:

  • Material Adverse Events Since the date of the latest audited financial statements included within the SEC Reports, except as specifically disclosed in a subsequent SEC Report filed prior to the date hereof, (i) there has been no event, occurrence or development that has had or that could reasonably be expected to result in a Material Adverse Effect, (ii) the Company has not incurred any liabilities (contingent or otherwise) other than (A) trade payables and accrued expenses incurred in the ordinary course of business consistent with past practice and (B) liabilities not required to be reflected in the Company’s financial statements pursuant to GAAP or required to be disclosed in filings made with the Commission, (iii) the Company has not altered its method of accounting, (iv) the Company has not declared or made any dividend or distribution of cash or other property to its stockholders or purchased, redeemed or made any agreements to purchase or redeem any shares of its capital stock and (v) the Company has not issued any equity securities to any officer, director or “Affiliate” (defined as any Person that, directly or indirectly through one or more intermediaries, controls or is controlled by or is under common control with a Person, as such terms are used in and construed under Rule 144 under the Act), except pursuant to existing Company stock option plans. The Company does not have pending before the Commission any request for confidential treatment of information. No event, liability or development has occurred or exists with respect to the Company or its Subsidiaries or their respective business, properties, operations or financial condition, that would be required to be disclosed by the Company under applicable securities laws at the time this representation is deemed made that has not been publicly disclosed at least 1 Trading Day prior to the date that this representation is deemed made.

  • Definition of Market Price The market price for any security shall be (i) the market price for that security quoted at the close of the trading day effective on the Bank Closing Date as published electronically by Bloomberg, L.P., or alternatively, at the discretion of the Receiver, by IDC/Financial Times (FT) Interactive Data; (ii) provided that if such market price is not available for such security, the Assuming Institution will submit a written purchase price bid for such security within three days of notification/bid request by the Receiver (unless a different time period is agreed to by the Assuming Institution and the Receiver) and the Receiver, in its sole and absolute discretion, will accept or reject each such purchase price bid; (iii) further provided that in the absence of an acceptable bid from the Assuming Institution, or in the event that a security is deemed essential to the Receiver as determined by the Receiver in its discretion (see Section 3.6 Retention or Repurchase of Assets Essential to the Receiver) such security shall not pass to the Assuming Institution and shall be deemed to be an excluded asset hereunder and listed on Schedule 3.5(l).

  • Material Adverse Event A Material Adverse Event occurs.

  • Description of Change in Terms A. Modification(s) to Loan Agreement.

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