Serious ADEs definition

Serious ADEs shall have the meaning set forth in Section 5.1.
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Serious ADEs means, any adverse drug event occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug event when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse. “Unexpected ADEs” means, any adverse drug event that is not listed in the current labeling for the Product. This includes events that may be symptomatically and pathophysiologically related to an event listed in the labelling, but differ THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. from the event because of greater severity or specificity. The roles and responsibilities of each Party in respect of ADE’s shall be specified in the Technical Agreement attached as Schedule E.
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Serious ADEs means, with respect to a serious adverse event or reaction, is any noxious and unintended response to a drug that at any dose: ● requires in-patient hospitalization or prolongation of existing hospitalization; ● causes congenital malformation; ● results in persistent or significant disability or incapacity; ● is a congenital anomaly/birth defect; ● is a medically important event or reaction; ● results in death; or ● is life-threatening.
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Examples of Serious ADEs in a sentence

  • Each of Cipher and Distributor and their respective Affiliates, SubDistributors, Approved Manufacturers, agents or other relevant parties shall inform the other of all known or suspected ADE’s associated with the Product in the Territory, of which it is notified, or otherwise becomes aware, as soon as reasonably possible but in any event quarterly for ADE’s and within seven (7) days for Serious ADEs and Unexpected ADE’s or within any time limits required by applicable Law, whichever is shorter.

  • Each of Can-Xxxx and Distributor and their respective Affiliates, SubDistributors, Approved Manufacturers, agents or other relevant parties shall inform the other of all known or suspected ADE’s associated with Supplied Product, of which it is notified, or otherwise becomes aware, as soon as reasonably possible but in any event within ten (10) days for ADEs and forty-eight (48) hours for Serious ADEs or within any time limits required by applicable Law, whichever is shorter.

  • Each of Can-Xxxx and CKD and their respective Affiliates, Sublicensees, Approved Manufacturers, agents or other relevant parties shall inform the other of all known or suspected ADE’s associated with a Product, of which it is notified, or otherwise becomes aware, as soon as reasonably possible but in any event within ten (10) days for ADEs and forty-eight (48) hours for Serious ADEs or within any time limits required by applicable Law, whichever is shorter.

Related to Serious ADEs

  • Serious crime means conduct constituting an offence punishable by a maximum deprivation of liberty of at least four years or a more serious penalty;

  • Serious Adverse Event means any adverse event that led to any of the following:

  • Serious health condition means an illness, injury, impairment, or physical or mental condition that involves:

  • Serious illness means an accident, injury, illness, disease, or physical or mental condition that: poses imminent danger of death; requires inpatient care in a hospital, hospice, or residential medical facility; or requires continuing in-home care under the direction of a physician or health care provider. Related current definitions are summarized in (f) below.

  • Serious damage ’ means any specific defect defined in this section; or an equally objectionable variation of any one of these defects, any other defect, or any combination of defects which se- riously detracts from the appearance, or the edible or marketing quality of the fruit. The following specific defects shall be considered as serious damage:

  • Serious means violations that either result in one or more neg- ative outcomes and significant actual harm to residents that does not constitute imminent danger, or there is a reasonable predictability of recurring actions, practices, situations, or incidents with potential for causing significant harm to a resident, or both.

  • Serious Breach means any breach defined as a Serious Breach in the Agreement or any breach or breaches which adversely, materially or substantially affect the performance or delivery of the Services or compliance with the terms and conditions of the Agreement or the provision of a safe, healthy and supportive learning environment or a breach of security that adversely affects the Personal Data or privacy of an individual. Failure to comply with Law, or actions or omissions by the Provider that endanger the Health or Safety of Learners, Provider Personnel, and all other persons including members of the public would constitute a Serious Breach;

  • Serious Mental Illness . means the following mental disorders as classi­

  • serious incident means any incident that directly or indirectly led, might have led or might lead to any of the following:

  • Infectious Disease means an illness that is capable of being spread from one individual to another.

  • Serious Misconduct means any misconduct identified as a ground for termination in the Motorola Code of Business Conduct, or the human resources policies, or other written policies or procedures.

  • Mysterious Disappearance means any disappearance of Property which, after a reasonable investigation has been conducted, cannot be explained.

  • Infectious agent means that term as defined in R 325.9031 of the Michigan administrative code.