Common use of Adverse Event Clause in Contracts

Adverse Event. Any adverse events, device malfunctions or quality complaints related to the Receiver products should be dealt in accordance with local legal requirements. Service Provider shall forward to the Receiver’s local vigilance representative, any vigilance related information, as soon as possible, at the Receiver’s address listed in the Service Agreement. In case the Service Provider is conducting Market research activities for the Receiver, the Service Provider is required to comply with the terms in Exhibit 1. In case the Service Provider is involved in the activities of handling, posting, reposting on Social Media on behalf of the Receiver, then the Service Provider is required to comply with the terms in Exhibit 2. Adverse Event (AE) is any untoward medical occurrence in a patient or clinical-trial subject administered a medicinal product/ Alcon Medical Device and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A complaint is any oral, electronic, or written communication that alleges deficiencies related to the identity (labelling), quality, durability, reliability, safety, effectiveness, or performance of a marketed product, including failure of the product, labelling or packaging to meet specifications, whether or not the product is related to or caused the alleged deficiency. Examples of product/device complaints include but are not limited to: Product dissatisfaction, Torn contact lenses, Lenses filmy, product not cleaning lenses, Broken haptic on an intraocular lens etc.