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 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.

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.

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-▇▇▇▇ 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-▇▇▇▇ 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.