DEFINITIONS Adverse Event definition

DEFINITIONS Adverse Event. Means any untoward medical occurrence associated with the use of a drug/device in humans, whether or not considered drug/device related. Affiliates: With respect to either Party, an Affiliate is any entity that is controlled by, controls, or is under common control with the Party named above. Applicable Law: Governing law as provided in the Governing law section (Section 15.9); the International Conference of Harmonization Guidelines for Good Clinical Practices (GCP) and the Helsinki Declaration as well as any other rules, and regulations applicable to this Agreement. KEĎŽE doc.
View Source

Examples of DEFINITIONS Adverse Event in a sentence

  • DEFINITIONS Adverse Event: Means any untoward medical occurrence associated with the use of a drug/device in humans, whether or not considered drug/device related.

Related to DEFINITIONS Adverse Event

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

  • Material Adverse Event means any circumstance or event that, individually or collectively with other circumstances or events, may reasonably be expected to have a material adverse effect on the financial condition or Business of the Borrower, as now conducted or as proposed to be conducted.

  • Unreasonable adverse effects on the environment means any unreasonable risk to humans or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide.

  • Adverse Event means any untoward medical occurrence in a human clinical trial subject or in a patient who is administered a Licensed Product, whether or not having a causal relationship with such Licensed Product, including, without limitation, any unfavorable and unintended sign (including, without limitation, abnormal laboratory findings of clinical concern), symptom or disease temporally associated with the use of such Licensed Product.

  • Deemed Material and Adverse Representation Each representation and warranty identified as such in Section 9.02 of this Agreement.