Signal Detection Sample Clauses

Signal Detection. Each Party shall promptly review all information concerning safety of the Product that it has obtained from any source, foreign or domestic, including data derived from clinical trials, epidemiologic studies, and commercial marketing experience reports as part of the scientific literature and from unpublished scientific papers. Of the said information concerning the safety of the Product, if a detected signal has impact on the established safety profile of the Product and new significant risk factors are identified, each Party shall expeditiously communicate the information to the other Party and prior to any specific safety measures.
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Signal Detection. Ultragenyx will be responsible for the conduct of surveillance and safety signal detection activity using the Global Safety Database and ad-hoc reports in accordance with Ultragenyx sponsored study procedures and will notify Physician of safety signals that do, or may, affect the safety profile of the Investigational Product, taking into consideration the urgency of the matter and the Applicable Laws. Ultragenyx será responsable de la realización de la actividad de vigilancia y detección de señales de seguridad utilizando la Base de Datos Global de Seguridad y los informes ad-hoc de acuerdo con los procedimientos de los estudios patrocinados por Ultragenyx y notificará al Médico las señales de seguridad que afecten o puedan afectar al perfil de seguridad del Producto en Investigación, teniendo en cuenta la urgencia del asunto y la Legislación Aplicable. Ultragenyx and Physician will promptly inform each other of all adverse event information relating to Investigational Product, including but not limited to, safety issues that any Party becomes aware of or material safety-related regulatory queries from regulatory authorities taking into consideration the urgency of the matter and the Applicable Laws. Ultragenyx may request assistance from Physician to evaluate and investigate such safety information and Physician undertakes to use reasonably diligent efforts to promptly investigate and respond to Ultragenyx’s requests. Ultragenyx y Physician se informarán mutuamente y con prontitud de toda la información de eventos adversos relacionados con el Producto en Investigación, incluyendo, pero sin limitarse a ello, los problemas de seguridad de los que cualquiera de las Partes tenga conocimiento o las consultas reglamentarias relacionadas con la seguridad de las autoridades reguladoras, teniendo en cuenta la urgencia del asunto y las Leyes Aplicables. Ultragenyx podrá solicitar asistencia al Médico para evaluar e investigar dicha información de seguridad y el Médico se compromete a realizar esfuerzos razonablemente diligentes para investigar y responder con prontitud a las solicitudes de Ultragenyx.
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Signal Detection. CMS shall immediately, and within one (1) Business Day, inform Gelesis in writing of any newly identified safety issue or signal, or any circumstance arising for the Product in the Territory where an action by a Party may be required to protect public health.
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Signal Detection. The objective of signal detection is to provide early warning or prompt detection of (or the absence of) a communicable disease or other biological hazard event through recognising signals in the data, to enable a timely public health response. Generally temporal and/or spatio-temporal methods are employed with baseline data used to see if there are patterns that are not ‘normal’.
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Signal Detection. The Parties shall keep each other informed of all material risks (e.g., based on nonclinical, clinical, quality, epidemiological studies or post marketing safety data) which become known to each Party that would be reasonably likely to have an adverse consequence on the benefit-risk assessment regarding the Licensed Product labeling, or may require immediate safety measures. This would include directives from Regulatory Authorities regarding changes in labeling that would restrict Licensed Product use.
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Signal Detection. 4.3.1 Company shall be responsible for identifying new risks of the product and for informing Dexcel immediately any safety concern or any change in risk- benefit balance of the product. Company will inform Dexcel about a validated signal within 10 days of validation. Dexcel will inform Company of any safety concerns identified by Dexcel within 10 calendar days. Dexcel will inform the national Health Authority with this information, if applicable.
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Signal Detection. Principal as holder of the global safety database will be responsible for signal detection activities. Principal shall promptly notify Distributor if it becomes aware of potential safety signals. Both Parties will discuss if there are further actions required with Principal, as the global safety database holder, having the right to make final decisions.
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Related to Signal Detection

  • Contamination The presence in, on or under land, air or water of a substance (whether a solid, liquid, gas, odour, heat, sound, vibration or radiation) at a concentration above the concentration at which the substance is normally present in, on or under land, air or water in the same locality, that presents a risk of Environmental Harm, including harm to human health or any other aspect of the Environment, or could otherwise give rise to a risk of non-compliance with any Statutory Requirement for the protection of the Environment.

  • Virus Management Transfer Agent shall maintain a malware protection program designed to deter malware infections, detect the presence of malware within the Transfer Agent environment.

  • Environmental, Health and Safety i. Environment, Health and Safety Performance. Seller acknowledges and accepts full and sole responsibility to maintain an environment, health and safety management system ("EMS") appropriate for its business throughout the performance of this Contract. Buyer expects that Seller’s EMS shall promote health and safety, environmental stewardship, and pollution prevention by appropriate source reduction strategies. Seller shall convey the requirement of this clause to its suppliers. Seller shall not deliver goods that contain asbestos mineral fibers.

  • Access Control Supplier will maintain an appropriate access control policy that is designed to restrict access to Accenture Data and Supplier assets to authorized Personnel. Supplier will require that all accounts have complex passwords that contain letters, numbers, and special characters, be changed at least every 90 days, and have a minimum length of 8 characters.

  • Waste and Nuisance The Lessee shall not commit, or suffer to be committed, any waste on the leased premises, nor shall he maintain, commit, or permit the maintenance or commission of any nuisance on the leased premises.

  • Network Access Control The VISION Web Site and the Distribution Support Services Web Site (the “DST Web Sites”) are protected through multiple levels of network controls. The first defense is a border router which exists at the boundary between the DST Web Sites and the Internet Service Provider. The border router provides basic protections including anti-spoofing controls. Next is a highly available pair of stateful firewalls that allow only HTTPS traffic destined to the DST Web Sites. The third network control is a highly available pair of load balancers that terminate the HTTPS connections and then forward the traffic on to one of several available web servers. In addition, a second highly available pair of stateful firewalls enforce network controls between the web servers and any back-end application servers. No Internet traffic is allowed directly to the back-end application servers. The DST Web Sites equipment is located and administered at DST’s Winchester data center. Changes to the systems residing on this computer are submitted through the DST change control process. All services and functions within the DST Web Sites are deactivated with the exception of services and functions which support the transfer of files. All ports on the DST Web Sites are disabled, except those ports required to transfer files. All “listeners,” other than listeners required for inbound connections from the load balancers, are deactivated. Directory structures are “hidden” from the user. Services which provide directory information are also deactivated.

  • Litigation; Regulatory Action (a) Except as set forth on Schedule 3.10 of the Company Disclosure Schedule, no litigation, claim, suit, investigation or other proceeding before any court, governmental agency or arbitrator is pending against the Company or any of its Subsidiaries, and, to the Knowledge of the Company, (i) no such litigation, claim, suit, investigation or other proceeding has been threatened and (ii) there are no facts which would reasonably be expected to give rise to such litigation, claim, suit, investigation or other proceeding.

  • Environmental, Health and Safety Laws There does not exist any violation by the Borrower or any Subsidiary of any applicable federal, state or local law, rule or regulation or order of any government, governmental department, board, agency or other instrumentality relating to environmental, pollution, health or safety matters which will or threatens to impose a material liability on the Borrower or a Subsidiary or which would require a material expenditure by the Borrower or such Subsidiary to cure. Neither the Borrower nor any Subsidiary has received any notice to the effect that any part of its operations or properties is not in material compliance with any such law, rule, regulation or order or notice that it or its property is the subject of any governmental investigation evaluating whether any remedial action is needed to respond to any release of any toxic or hazardous waste or substance into the environment, the consequences of which non-compliance or remedial action could constitute an Adverse Event.

  • Waste Borrower shall not commit or suffer any waste of the Property or make any change in the use of the Property which will in any way materially increase the risk of fire or other hazard arising out of the operation of the Property, or take any action that might invalidate or give cause for cancellation of any Policy, or do or permit to be done thereon anything that may in any way impair the value of the Property or the security of this Security Instrument. Borrower will not, without the prior written consent of Lender, permit any drilling or exploration for or extraction, removal, or production of any minerals from the surface or the subsurface of the Land, regardless of the depth thereof or the method of mining or extraction thereof.

  • Investigation and Prevention Transfer Agent shall reasonably assist Fund in investigating of any such unauthorized access and shall use commercially reasonable efforts to:

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