Causality Sample Clauses

Causality. Relationship to a device refers to a determination of the relationship (if any) between an AE and the device. A causal relationship is present if a determination is made that there is a reasonable possibility that the AE may have been caused by the device. An AE could be considered procedure-related when, in the judgment of the Investigator, it is reasonable to believe that the event is associated with the procedure, regardless of the relationship to the study device. Procedure-related causes that contribute to the occurrence of the event can be attributed to other products, surgical techniques, or medications required specifically for the procedure. Relationship to the device or procedure must be determined by the Investigator and cannot be delegated to other study staff. Causality will be assessed as: - the event is not a known side effect of the product category the device belongs to or of similar devices and procedures; - the event has no temporal relationship with the use of the investigational device or the procedures. - the serious event does not follow a known response pattern to the medical device (if the response pattern is previously known) and is biologically implausible; - the discontinuation of medical device application or the reduction of the level of activation/exposure - when clinically feasible – and reintroduction of its use (or increase of the level of activation/exposure), do not impact on the serious event; - the event involves a body-site or an organ not expected to be affected by the device or procedure; - the serious event can be attributed to another cause (e.g. an underlying or concurrent illness/ clinical condition, an effect of another device, drug, treatment or other risk factors); - the event does not depend on a false result given by the investigational device used for diagnosis, when applicable; - xxxxx to the subject are not clearly due to use error; - in order to establish the non-relatedness, not all the criteria listed above might be met at the same time, depending on the type of device/procedures and the serious event.
Sample 1
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Causality. The relationship between the use of the medical device (including the medical - surgical procedure) and the occurrence of each adverse event shall be assessed and categorized. During causality assessment activity, clinical judgement shall be used and the relevant documents, such as the Investigator’s Brochure, the Clinical Investigation Plan or the Risk Analysis Report shall be consulted, as all the foreseeable serious adverse events and the potential risks are listed and assessed there. The presence of confounding factors, such as concomitant medication/treatment, the natural history of the underlying disease, other concurrent illness or risk factors shall also be considered. The above considerations apply also to the serious adverse events occurring in the comparison group.
Sample 1
Causality. There is a direct causal relationship between the measures taken by the Government and the damage to the investor, since the expropriation of the xxxxx and the loss of expected profits can only be attributed to the Government of Xxxxxxxx.
Sample 1
Causality. In the event the Hangar or the Hangar Space, or the means of access thereto, shall be damaged by fire or any other case, the rent payable hereunder shall not xxxxx provided that the Hangar Space is not rendered untenable by such damage. If the Hangar Space is rendered untenable and Lessor elects to repair the Hangar or Hangar Space, the rent shall xxxxx for the period during which such repairs are being made, provided the damage was not caused by the acts or omissions of Lessee, its employees, agents or invitees, in which case the rent shall not xxxxx. If the Hangar Space is rendered untenable and Lessor elects not to repair the Hangar or Hangar Space, this Agreement shall terminate.
Sample 1

Related to Causality

  • Impact direct impact on people does not necessarily require direct contact, for example, environmental health, trading standards and similar officers may have a direct impact on people, through the implementation or enforcement of regulations, without necessarily having direct contact with those who benefit.

  • Special Risks or Circumstances City reserves the right to modify these requirements, including limits, based on the nature of the risk, prior experience, insurer, coverage, or other special circumstances.

  • Grievability Denial of a petition for reinstatement is grievable. The grievance may not be based on information other than that shared with the Employer at the time of the petition for reinstatement.

  • Outcome Include the following: 1) evaluation of project’s ability to meet goals and expected performance measures and provide explanation for why goals were not met, if applicable; 2) identify successful outcomes, areas for improvement, and quantifiable metrics (including the assigned metric in Exhibit A, if applicable) as a result of the project; and 3) final project photos, if an implementation construction project.

  • No Material Adverse Change in Business Except as otherwise stated therein, since the respective dates as of which information is given in the Registration Statement, the General Disclosure Package or the Prospectus, (A) there has been no material adverse change in the condition, financial or otherwise, or in the earnings, business affairs or business prospects of the Company and its subsidiaries considered as one enterprise, whether or not arising in the ordinary course of business (a “Material Adverse Effect”), (B) there have been no transactions entered into by the Company or any of its subsidiaries, other than those in the ordinary course of business, which are material with respect to the Company and its subsidiaries considered as one enterprise, and (C) there has been no dividend or distribution of any kind declared, paid or made by the Company on any class of its capital stock.

  • Constructability Review Prepare detailed interdisciplinary constructability review within Fourteen (14) days of receipt of the plans from the District that: 10.1.2.1.6.1 Ensures construction documents are well coordinated and reviewed for errors; 10.1.2.1.6.2 Identifies to the extent known, construction deficiencies and areas of concern; 10.1.2.1.6.3 Back-checks design drawings for inclusion of modifications; and 10.1.2.1.6.4 Provides the District with written confirmation that: 10.1.2.1.6.4.1 Requirements noted in the design documents prepared for the Project are consistent with and conform to the District's Project requirements and design standards. 10.1.2.1.6.4.2 Various components have been coordinated and are consistent with each other so as to minimize conflicts within or between components of the design documents.

  • Environmental Impact Notwithstanding any other term, covenant or condition contained in this Lease, in the event that any Alteration has any adverse environmental impact on the Premises. Landlord may deny Tenant the right to proceed in Landlord’s sole and absolute discretion.

  • No Material Adverse Changes There shall not have occurred any material adverse change in the condition (financial or otherwise), properties, assets (including intangible assets), liabilities, business, operations, results of operations or prospects of Acquiror and its subsidiaries, taken as a whole.

  • No Material Adverse Change No event or condition of a type described in Section 3(h) hereof shall have occurred or shall exist, which event or condition is not described in the Pricing Disclosure Package (excluding any amendment or supplement thereto) and the Prospectus (excluding any amendment or supplement thereto) and the effect of which in the judgment of the Representatives makes it impracticable or inadvisable to proceed with the offering, sale or delivery of the Shares on the Closing Date or the Additional Closing Date, as the case may be, on the terms and in the manner contemplated by this Agreement, the Pricing Disclosure Package and the Prospectus.

  • Contamination The presence in, on or under land, air or water of a substance (whether a solid, liquid, gas, odour, heat, sound, vibration or radiation) at a concentration above the concentration at which the substance is normally present in, on or under land, air or water in the same locality, that presents a risk of Environmental Harm, including harm to human health or any other aspect of the Environment, or could otherwise give rise to a risk of non-compliance with any Statutory Requirement for the protection of the Environment.

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