Vigilance Sample Clauses

Vigilance. Distributor shall promptly notify S4S of any infringement in the Territory of S4S’s Trademarks that comes to Distributor’s notice.
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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.
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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 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 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 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. 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 for properly monitoring the file includes, if applicable: - The removal plan - The slips for taking care of and transferring waste with identification of the recip...
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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.
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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.
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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.
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Vigilance 
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Related to Vigilance

  • Pharmacovigilance Licensee shall maintain until the termination of this Agreement (or, as applicable, until the rights and obligations intended to survive termination of this Agreement have been fulfilled) pharmacovigilance and risk management systems, procedures and documentation needed to perform and comply with its regulatory obligations and its related obligations under this Agreement. Licensee shall ensure that it will comply with all Applicable Law regarding Licensed Product in the Territory, including, without limitation, those laws and regulations relating to risk management, drug safety and pharmacovigilance. If Licensee becomes aware of any adverse reaction relating to Licenced Product in connection with this Agreement, Licensee shall inform MPP and Pfizer within twenty-four (24) hours of its becoming aware and cooperate with Pfizer in fulfilling Pfizer’s reporting responsibilities under Applicable Law. Licensee will be responsible for fulfilling all pharmacovigilance activities pursuant to the local regulations and requirements for the Licenced Products in the Territory and provide MPP and Pfizer with a report containing information regarding all such activities. Such report shall be provided annually, on February 1 of each year, and otherwise on reasonable request by MPP or Pfizer to both MPP and Pfizer’s pharmacovigilance contact as may be designated by Pfizer from time to time. Licensee shall notify MPP and Pfizer forthwith of the receipt of an enquiry from an Agency in the Territory relating to Licensed Product that concerns any safety issue. If Licensee becomes aware of any action that may be, will be or has been taken by an Agency for a safety reason connected with Licensed Product, it shall immediately, and in any event no later than twenty-four

  • Pharmacovigilance Agreement Subject to the terms of this Agreement, and at a date to be determined by the JDC, Facet and Trubion shall define and finalize the actions the Parties shall employ to protect patients and promote their well-being in a written agreement (hereinafter referred to as the “Pharmacovigilance Agreement”). These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Collaboration Product. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations to Governmental Authorities. Furthermore, such agreed procedures shall be consistent with relevant ICH guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall prevail. The Pharmacovigilance Agreement will provide for a worldwide safety database to be maintained by the Party appointed by the JDC. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement (as the Parties may agree to modify it from time to time) and to cause its Affiliates and permitted sublicensees to comply with such obligations.

  • Regulatory Cooperation In connection with any foreclosure, collection, sale or other enforcement of Liens granted to the Administrative Agent in the Collateral Documents, Parent will, and will cause its Restricted Subsidiaries to, reasonably cooperate in good faith with the Administrative Agent or its designee in obtaining all regulatory licenses, consents and other governmental approvals necessary or (in the reasonable opinion of the Administrative Agent or its designee) reasonably advisable to conduct all aviation operations with respect to the Collateral and will, at the reasonable request of the Administrative Agent and in good faith, continue to operate and manage the Collateral and maintain all applicable regulatory licenses with respect to the Collateral until such time as the Administrative Agent or its designee obtain such licenses, consents and approvals, and at such time Parent will, and will cause its Restricted Subsidiaries to, cooperate in good faith with the transition of the aviation operations with respect to the Collateral to any new aviation operator (including, without limitation, the Administrative Agent or its designee).

  • Protocols Each party hereby agrees that the inclusion of additional protocols may be required to make this Agreement specific. All such protocols shall be negotiated, determined and agreed upon by both parties hereto.

  • Procurement procedures 11.1 The Recipient must secure the best value for money and shall act in a fair, open and non-discriminatory manner in all purchases of goods and services.

  • Safety Procedures The Contractor shall: (a) comply with all applicable safety regulations according to Attachment H; (b) take care for the safety of all persons entitled to be on the Site; (c) use reasonable efforts to keep the Site and Works clear of unnecessary obstruction so as to avoid danger to these persons; (d) provide fencing, lighting, guarding and watching of the Works until completion and taking over under clause 10 [Employer's Taking Over]; and (e) provide any Temporary Works (including roadways, footways, guards and fences) which may be necessary, because of the execution of the Works, for the use and protection of the public and of owners and occupiers of adjacent land.

  • Mechanisms for Cooperation Pursuant to Article 149 (Objectives), the Parties hereby establish a Committee on Cooperation comprising representatives of each Party.

  • Research Use Reporting To assure adherence to NIH GDS Policy, the PI agrees to provide annual Progress Updates as part of the annual Project Renewal or Project Close-out processes, prior to the expiration of the one (1) year data access period. The PI who is seeking Renewal or Close-out of a project agree to complete the appropriate online forms and provide specific information such as how the data have been used, including publications or presentations that resulted from the use of the requested dataset(s), a summary of any plans for future research use (if the PI is seeking renewal), any violations of the terms of access described within this Agreement and the implemented remediation, and information on any downstream intellectual property generated from the data. The PI also may include general comments regarding suggestions for improving the data access process in general. Information provided in the progress updates helps NIH evaluate program activities and may be considered by the NIH GDS governance committees as part of NIH’s effort to provide ongoing stewardship of data sharing activities subject to the NIH GDS Policy.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Quality Management System Supplier hereby undertakes, warrants and confirms, and will ensue same for its subcontractors, to remain certified in accordance with ISO 9001 standard or equivalent. At any time during the term of this Agreement, the Supplier shall, if so instructed by ISR, provide evidence of such certifications. In any event, Supplier must notify ISR, in writing, in the event said certification is suspended and/or canceled and/or not continued.

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