Causality Sample Clauses

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 ▇▇▇▇▇ and the loss of expected profits can only be attributed to the Government of ▇▇▇▇▇▇▇▇.

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.

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; - ▇▇▇▇▇ 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.

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 ▇▇▇▇▇ 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 ▇▇▇▇▇ 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 ▇▇▇▇▇. If the Hangar Space is rendered untenable and Lessor elects not to repair the Hangar or Hangar Space, this Agreement shall terminate.