Vigilance. Distributor shall promptly notify S4S of any infringement in the Territory of S4S’s Trademarks that comes to Distributor’s notice.
Vigilance. To inform ITC about incidents and adopted corrective actions, including the contact data regarding the competent authority addressed – MEDDEV 2.12-1 rev. 8 *) Immediately after receiving of information about an incident, after a set-up of corrective actions and after their efficiency verification To inform ITC about changes regarding authorized representative in EU – MEDDEV 2.5/10 )* Immediately after any change of the representative, his address or his authorization scope Notification of any plan for substantial changes to the quality system or the product-range covered by it **) Immediately notify ITC of the plan and wait for ITC decision about proposed changes approval or refusal Notification of any change in the approved design of the product that could affect conformity with the essential requirements of the relevant Directive on medical devices ***) Immediately notify ITC and wait for ITC decision about approval or refusal of the device design change In the case of medical devices containing a medicinal substance – notification ITC about any change regarding used raw materials or technology of the medicinal product manufacture. Notify ITC immediately after receiving the information from the medicinal product supplier. This change is a subject of an obligation to apply at medicines competent authority SÚKL for additional scientific opinion confirming the that the quality and safety of the substance are maintained For IVD devices: To inform ITC about changes to the pathogen and markers of infections to be tested, including ability of such changes to affect the performance of IVD medical device concerned. Notify ITC immediately after receiving the information and after evaluation of the possibility to affect the performance of the IVD device in question. Notes:
Vigilance. You must pay attention to possible changes in the state of preservation of these materials. If you notice a well-known change in the state of preservation of a material containing asbestos, in its close environment or if the current use of the premises has an effect on this risk, you must contact the person in charge of the asbestos technical file who can be reached at the address indicated in the preamble of the summary sheet. In the event of an incident In the event of accidental dispersion of asbestos fibres: - Prohibit all persons from accessing the area - Confine the potentially contaminated area without taking risks - Contact the person in charge of the asbestos technical file Specific provisions None Copyright Provexi SAS – xxx.xxxxxxx.xx Site No. PG40026 – 10, xx Xxxxxxxxx Summary sheet version t-01 01/08/2006 0/00 xxx Xx Xxxxxxxx 00000 PARIS Asbestos technical file All premises Instructions in the event of works on or near materials containing asbestos When works are planned, the general safety instructions do in no way replace the existing statutory obligations regarding risk prevention for workers. The reinforce measures are set by the regulations relative to the protection of workers against risks related to the inhalation of asbestos dust (decree 96-98 amended). Generally, your business activity is subject to the obligations promulgated by Article L. 230-2 of the Labour Code: - Obligation for the employer to ensure the health and safety of workers (I of Article L.230-2) - Implementation of general professional risk prevention principles (II of Article L. 230-2) - Obligation to evaluate the risks (III of Article L. 230-2). If, after the completion of the works, you notice a well-known change in the state of the material containing asbestos or its close environment, you must indicate this to the person in charge of the asbestos technical file who can be reached at the address indicated in the preamble of the summary sheet. Specific provisions Any work project which is likely to affect the material containing asbestos must be the subject of a prior request to the owner or its representative, and must be carried out in adherence to the specific technical clauses applicable locally, if any. It is compulsory to supply all documents relative to the works concerning the materials or products containing asbestos to the owner or its representative with a view to meeting the provisions of Article R1334-26 of the Public Health Code; the book of documents ...
Vigilance. Plexus shall promptly notify GenMark if it becomes aware of any information about the Products indicating that it may not conform to the Specifications or otherwise perform as intended. The parties will promptly confer to discuss such circumstances and to consider appropriate courses of action. In the event that (a) an event, incident, or circumstance may result in the need for a removal of any Product or any lot or lots thereof from the market or any regulatory reportable event occurs which is attributable to the Product, (b) any Governmental Authority threatens to prohibit the use of any Product as a result of a defect of the Product, or (c) any Governmental Authority requires distribution of a “Dear Doctor” letter or its equivalent regarding the use of any Product, in each case the parties shall promptly advise each other in writing, and shall provide each other with copies of all relevant correspondence, notices and the like. Notwithstanding anything to the contrary herein, GenMark shall have final authority to make all decisions relating to corrective and/or preventive action with respect to Products. Internal investigation of any such event will take place promptly after the parties become aware of the reportable event and the root cause and appropriate remedial measures will be determined and documented to the best of the parties’ capabilities. GenMark or its designee will make all contacts with any Governmental Authorities in respect of any event described in this Section 3.11 and will be responsible for coordinating all of the necessary activities in connection with such action. Plexus will cooperate with GenMark in the conduct of any such activities. Notwithstanding anything to the contrary herein, GenMark is solely responsible for all complaint handling, including, without limitation, maintenance of complaint files, investigation and resolution of complaints, trend analysis of complaints, and maintenance of complaint-related records. GenMark is solely responsible for FDA medical device reporting obligations under 21 CFR Part 803 and similar reporting regulations in jurisdictions outside the United States. GenMark shall promptly provide to Plexus copies of all written complaints of any Governmental Authority received by GenMark that relate to any Product. Plexus shall provide to GenMark information regarding any complaints Plexus receives about the Products.
Vigilance. Instructions shall advise operators to cease operation if there is cause to suspect hazard or malfunction, with gui- dance concerning the particular machinery and advice to report to maintenance personnel.
Vigilance. To measure vigilance, we used a racism-related vigilance measure created from ethnographic research that described how individuals anticipate and prepare for racial discrimination (Essed, 1991). The 4-item scale ask responses to the following questions: In your day-to-day life, how often do you do the following things: “try to prepare for possible insults from other people before leaving home?” “feel that you always have to be very careful about your appearance to get good service or avoid being harassed?” “carefully watch what you say and how you say it” and “try to avoid certain social situations and places?” Responses were on a 6-point Likert scale ranging, from “almost everyday” to “never”. Both discrimination measures, the everyday discrimination and vigilance scale, were reverse coded and then summed, with higher values representing higher levels of perceived discrimination and vigilance.
Vigilance
