![]() ![]() Related current definitions are summarized in (f) below. 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. Serious health condition means an illness, injury, impairment, or physical or mental condition that involves: Serious Adverse Event means any adverse event that led to any of the following: ![]() ![]() 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 assault means an act that constitutes a felony violation of chapter XI of the Michigan penal code, 1931 PA 328, MCL 750.81 to 750.90h, or that constitutes an assault and infliction of serious or aggravated injury under section 81a of the Michigan penal code, 1931 PA 328, MCL 750.81a. Serious harm means harm, whether physical or nonphysical, including psychological, economic, or reputational, to an individual which would compel a reasonable individual of the same background and in the same circumstances to perform or continue to perform labor or services or sexual activity to avoid incurring the harm. The roles and responsibilities of each Party in respect of ADE’s shall be specified in the Technical Agreement attached as Schedule E.Įach 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.Įach 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.Įach 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.Īs explained in our consultation paper, the IRD has all along been applying the arm’s length principle to transactions between associated enterprises, regardless of the size and nature of the enterprises concerned. from the event because of greater severity or specificity. ![]() REDACTED MATERIAL IS MARKED WITH AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 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. “ Unexpected ADEs” means, any adverse drug event that is not listed in the current labeling for the Product. 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. 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. 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. ![]()
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