Medical Device Regulation Sample Clauses

Medical Device Regulation. If any of the Products are medical devices, Buyer acknowledges that it is familiar with SOR /98-282 Medical Devices Regulations and the reporting obligations imposed on device users thereunder. In this regard, Xxxxx agrees to notify ZEISS within ten (10) days of the occurrence of any event identified in the Regulations imposing a reporting obligation on Buyer and/or ZEISS, except for critical incident events representing an imminent hazard that require notification to Health Canada within ten days, in which case, such notice will be delivered to ZEISS immediately. Buyer shall maintain adequate tracking for the Products to enable ZEISS to meet the Health Canada requirements applicable to the tracking of medical devices.
Sample 1
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Medical Device Regulation. In the event Customer uses the SDK to build mobile applications, Customer is solely responsible for complying with all regulatory laws and rules applying to such mobile applications, including but not limited to the laws on medical devices and licensing and professional practice requirements. If Customer is subject to EU laws, Customer will not use the SDK to develop medical devices of class 2 and above as defined in Medical Device Directive 93/42/EEC.
Sample 1
Medical Device Regulation. As to each product subject to the jurisdiction of the FDA under the Federal Food, Drug, and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) or to the jurisdiction of the EMA, AMAR or any other regulatory agency or body of any other country performing similar functions (a “Foreign Device Regulator”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its subsidiaries (each such product, a “Regulated Product”), such Regulated Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have or reasonably be expected to result in a Material Adverse Effect. There is no pending, completed or, to the Company’s knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its subsidiaries, and none of the Company or any of its subsidiaries has received any notice, warning letter or other communication from the FDA or any Foreign Device Regulator, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Regulated Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Regulated Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its subsidiaries, (iv) enjoins production at any facility of the Company or any of its subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its subsidiaries, and which, either individually or in the aggregate, would not have or reasonably be expected to result in a Mate...
Sample 1
Medical Device Regulation. Companies informs Distributor that Sections 1, 2, and 3 are requirements of the Medical Device Directive (93/42/EEC), and that non respect by Distributor of these sections will oblige Companies to immediately cease supply of Products to Distributor, and will be regarded as failure to perform a material obligation, warranty, duty or responsibility.
Sample 1
Medical Device Regulation. Except as set forth in Schedule 3.17, Seller has obtained all applicable licenses, registrations, approvals, clearances, and authorizations required by Governmental Authorities regulating the safety, effectiveness and market clearance of Seller's medical devices which are currently marketed by Seller in respect of the territories in which such devices are currently marketed. Such licenses, registrations, approvals, clearances, and authorizations have not been withdrawn, revoked or challenged and to Seller's Knowledge, Seller has not taken any action with respect to the design, development, manufacture or distribution of any such medical device which could reasonably be expected to lead to such withdrawal, revocation or challenge. Set forth in Schedule 3.17 is information relating to the regulation of Seller's medical devices that are currently marketed or that have been approved for marketing
Sample 1
Medical Device Regulation. (a) Company has obtained all applicable licenses, registrations, approvals, clearances, and authorizations required for Company's business by any governmental entity regulating the safety, effectiveness and market clearance of Company's medical components or devices that are currently marketed by Company in the territories in which such components or devices are currently marketed. Such licenses, registrations, approvals, clearances, and authorizations have not been withdrawn, revoked or challenged and Company has not taken any action with respect to the design, development, manufacture or distribution of any such medical component or device which could reasonably be expected to lead to such withdrawal, revocation or challenge. Set forth on Schedule 3.18 is information related to the regulation of Company's medical devices that are currently marketed or that have been approved for marketing since January 1, 1997, including any recalls, product actions and inspections of Company's Facilities.
Sample 1

Related to Medical Device Regulation

  • Medical Devices This Article applies when the Goods and/or Services involve UC purchasing or leasing one or more medical devices from Supplier, or when Supplier uses one or more medical devices in providing Goods and/or Services to UC. Medical Device as used herein will have the meaning provided by the U.S. Food and Drug Administration (“FDA”) and means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: (i) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them; (ii) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (iii) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. Supplier warrants that prior to UC’s purchase or lease of any Medical Device or Supplier’s use of any Medical Device in providing Goods and/or Services hereunder, Supplier will: (i) perform security testing and validation for each such Goods and/or Services or Medical Device, as applicable; (ii) perform a security scan by an anti-virus scanner, with up-to-date signatures, on any software embedded within any Goods and/or Services or Medical Device, as applicable, in order to verify that the software does not contain any known viruses or malware; (iii) conduct a vulnerability scan encompassing all ports and fuzz testing; and (iv) provide UC with reports for (i) – (iii). Supplier warrants that all security testing performed by Supplier covers all issues noted in the “SANS WE TOP 25” and/or “OWASP Top 10” documentation. Throughout Supplier’s performance of this Agreement, Supplier will provide UC with reasonably up-to-date patches, firmware and security updates for any Medical Device provided to UC, and any other Medical Device used in the course of providing Services, as applicable. All such patches and other security updates will be made available to UC within thirty (30) days of its commercial release or as otherwise recommended by Supplier or Supplier’s sub-supplier, whichever is earlier. Supplier warrants that all software and installation media not specifically required for any Medical Device used by Supplier or Goods and/or Services delivered to UC under this Agreement as well as files, scripts, messaging services and data will be removed from all such Goods and/or Services or Medical Device following installation, and that all hardware ports and drives not required for use or operation of such Goods and/or Services or Medical Device will be disabled at time of installation. In addition, Medical Devices must be configured so that only Supplier-approved applications will run on such Medical Devices. Supplier agrees that UC may take any and all actions that it, in its sole discretion, deems necessary to address, mitigate and/or rectify any real or potential security threat, and that no such action, to the extent such action does not compromise device certification, will impact, limit, reduce or negate Supplier’s warranties or any of Supplier’s other obligations hereunder. Supplier warrants that any Medical Device provided to UC, and any other Medical Device used in the course of providing such Goods and/or Services, meet and comply with all cyber-security guidance and similar standards promulgated by the FDA and any other applicable regulatory body. If the Goods and/or Services entail provision or use of a Medical Device, Supplier will provide UC with a completed Manufacturer Disclosure Statement for Medical Device Security (MDS2) form for each such Medical Device before UC is obligated to purchase or lease such Medical Device or prior to Supplier’s use of such device in its performance of Services. If Supplier provides an MDS2 form to UC concurrently with its provision of Goods and/or Services, UC will have a reasonable period of time to review such MDS2 form, and if the MDS2 form is unacceptable to UC, then UC in its sole discretion may return the Goods or terminate the Agreement with no further obligation to Supplier.

  • Alcohol and Drug Testing Employee agrees to comply with and submit to any Company program or policy for testing for alcohol abuse or use of drugs and, in the absence of such a program or policy, to submit to such testing as may be required by Company and administered in accordance with applicable law and regulations.

  • Alcohol and Drug-Free Workplace City reserves the right to deny access to, or require Contractor to remove from, City facilities personnel of any Contractor or subcontractor who City has reasonable grounds to believe has engaged in alcohol abuse or illegal drug activity which in any way impairs City's ability to maintain safe work facilities or to protect the health and well-being of City employees and the general public. City shall have the right of final approval for the entry or re-entry of any such person previously denied access to, or removed from, City facilities. Illegal drug activity means possessing, furnishing, selling, offering, purchasing, using or being under the influence of illegal drugs or other controlled substances for which the individual lacks a valid prescription. Alcohol abuse means possessing, furnishing, selling, offering, or using alcoholic beverages, or being under the influence of alcohol.

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • Occupational Health and Safety Act The Employer, the Union and the employees agree to be bound by the provisions of the Occupational Health and Safety Act, S.N.S. 1996, c.7.

  • SAFETY REGULATIONS Equipment shall meet all State and Federal safety regulations.

  • DRUG/ALCOHOL TESTING 8.1 The parties agree that the maintenance of a drug/alcohol free work place is a goal of both the College and the Union. Employees are prohibited from possession, consumption and/or being under the influence of a controlled substance/alcohol while on the College’s premises or during time paid by the employer. Violations of this prohibition may result in a disciplinary action up to and including termination.

  • Occupational Health & Safety (a) It is a mutual interest of the parties to promote health and safety in workplaces and to prevent and reduce the occurrence of workplace injuries and occupational diseases. The parties agree that health and safety is of the utmost importance and agree to promote health and safety and wellness throughout the organization. The employer shall provide orientation and training in health and safety to new and current employees on an ongoing basis, and employees shall attend required health and safety training sessions. Accordingly, the parties fully endorse the responsibilities of employer and employee under the Occupational Health and Safety Act, making particular reference to the following:

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

  • Fire Regulations All Exhibitors must comply with the regulations of the local authority and applicable law as they relate to the design and construction of Exhibition stands, and the use of suitably fireproofed materials.

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