Applicable Laws and Standards definition
Applicable Laws and Standards means (a) all laws, ordinances, rules, directives and regulations applicable to the Products, the Project or this Agreement, including without limitation applicable local laws and regulations in each country in the Transave Territory, (b) applicable regulations and guidelines of the FDA and other Regulatory Authorities and the ICH guidelines; (c) as applicable to the particular activities performed, Good Manufacturing Practices, Good Laboratory Practices and Good Clinical Practices promulgated by the FDA and other Regulatory Authorities or the ICH; and (d) all applicable industry and trade standards, including the applicable standards of the International Organization for Standardization (ISO).
Applicable Laws and Standards means (a) all applicable laws, ordinances, rules, orders, directives and regulations of any and all supra-national, federal, state, provincial and local authorities and agencies, including without limitation all laws and regulations of such territories applicable to the maintenance of the manufacturing equipment and facilities and the manufacturing, transportation, storage, use, handling and disposal of medical devices, components and of any hazardous materials, (b) applicable regulations and guidelines of the FDA and other Regulatory Authorities and the ICH guidelines; (c) as applicable to the particular activities performed, Good Manufacturing Practices, Good Laboratory Practices and Good Clinical Practices promulgated by the FDA and other Regulatory Authorities or the ICH; and (d) all applicable industry and trade standards, including the applicable standards of the International Organization for Standardization (ISO).
Applicable Laws and Standards means all applicable engineering and safety laws, guidelines and standards governing the installation, maintenance and operation of any facility or structure in the public right-of-way, and the performance of all work in or around any facility or structure, and includes but is not limited to: the most current versions of the National Electric Safety Code (“NESC”), the Manual on Uniform Traffic Control Devices (“MUTCD”), the National Electrical Code (“NEC”), the guidelines of the Federal Communication Commission (“FCC”) and the Occupational Safety and Health Administration (“OSHA”); uniform building, fire, electrical, plumbing, or mechanical codes adopted by a recognized national code organization or local amendments to those codes, highway engineering manuals,
Examples of Applicable Laws and Standards in a sentence
The Applicable Laws and Standards shall include, but not be limited to, state and federal privacy and security laws related to the use and disclosure of health and medical information, the requirements of the Department of Health ("DOH"), The Joint Commission and the National Committee on Quality Assurance ("NCQA"), as applicable.
Contractor shall include in any permitted subcontract a requirement to comply with the following Contract provisions: 6.6 Representations and Warranties, 6.10 Compliance with Applicable Laws and Standards, 6.11 Governing Law, 6.12 Venue; Consent to Jurisdiction, 6.13 Indemnification, 6.14 False Claims, 6.18 Access To Records, and, if applicable, Exhibit B – Prevailing Wage Rates.
The Parties shall retain audit logs in accordance with Applicable Laws and Standards and in all cases for at least thirty (30) days.
Subject to the provisions of Section 5.5, Centogene will be responsible that the Contract DBS Test Kits, including but not limited to the Patient’s informed consent forms, comply at the point of time of the Yearly Review with Applicable Laws and Standards of the respective destination country.
Centogene shall maintain and document a vigilance system for Contract DBS ▇▇.▇▇ Kits which is in accordance with Regulatory Approvals, Applicable Laws and Standards.
More Definitions of Applicable Laws and Standards
Applicable Laws and Standards means all applicable federal, state, and local laws, statutes, acts, ordinances, rules, codes, standards, regulations and judicial or administrative decisions promulgated by any governmental agency, as any of the foregoing may be amended, modified, codified, reenacted, promulgated or published, in whole or in part, and in effect from time to time which is enforceable against a Party. Without limiting the generality of the foregoing, “Applicable Laws and Standards” includes HIPAA, as defined below.
Applicable Laws and Standards means (a) all laws, ordinances, rules, directives and regulations applicable to the Materials, the Evaluation Purpose, the Evaluation Studies, the Services or this Agreement, including without limitation applicable local laws and regulations in each relevant country, (b) applicable regulations and guidelines of the U.S. Food and Drug ACTIVE/204255671.1 Administration (“FDA”) and other regulatory authorities and applicable guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”), (c) as applicable to the particular activities performed under this Agreement, Good Manufacturing Practices, Good Laboratory Practices and Good Clinical Practices promulgated by the FDA and other regulatory authorities or the ICH, and (d) all applicable industry and trade standards.”
Applicable Laws and Standards means all laws, rules, regulations, and licensing requirements that are now or hereafter promulgated by any local, state, and federal governmental authority or agency that governs or applies to their respective duties and obligations hereunder and with any and all rules and/or standards that are now or hereafter promulgated by any accrediting or administrative body that governs or applies to their respective duties and obligations hereunder.
Applicable Laws and Standards means:
(a) all existing and/or enacted or later enacted laws, rules, ordinances, codes, regulations, treaties, orders, decisions, directives and/or requirements of any governmental, judicial or administrative body, of the Country of Origin of any Product, any country in which a component part of any Product is manufactured, distributed or offered, the United States, Canada, Mexico, each U.S. state, Canadian Province and each locality and jurisdiction where the Products are sold, whether in the United States or in any foreign country, whether or not such laws or standards are specifically referred to in this Agreement, whether amended or modified, including, but not limited to, the Federal Trade Commission (“FTC”); Federal Communications Commission (“FCC”); U.S. Food and Drug Administration (“FDA”); Environmental Protection Agency (“EPA”); Consumer Products Safety Commission (“CPSC”) and the U.S. Department of Transportation, including without limitation, the Consumer Product Safety Act; ▇▇▇▇▇▇▇▇-▇▇▇▇ Warranty-Federal Trade Commission Improvement Act; Wool Products Labeling Act; Federal Food, Drug and Cosmetics Act; Federal Hazardous Substances Act; California Safe Drinking Water and Toxic Enforcement Act of 1986 (“Proposition 65”); the ▇▇▇▇▇▇▇▇-▇▇▇▇▇▇ Act; Hazardous Materials Transportation Act; the Solid Waste Disposal Act, including the Resource Conservation and Recovery Act; the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA”); the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”); the Toxic Substances Control Act (‘‘TCSA”); the Marine Mammal Protection Act; the Endangered Species Act; the Forest and Rangeland Renewable Resources Planting Act of 1974; the Federal Water Pollution Control Act; the Clean Air Act; the Noise Control Act; the National Environmental Policy Act; the Safe Drinking Water Act; the Emergency Planning and Community Right-to-Know Act; the Pollution Prevention Act of 1990; the Montreal Protocol on Substances that Deplete the Ozone Layer; the Atomic Energy Act; Fair Packaging and Labeling Act; Textile Fiber Products Identification Act NAFTA and any other trade agreement(s); and the export and re-export control laws of the U.S. or any other app\cable jurisdiction; and
(b) all rules, regulations, requirements and standards of any applicable industry or trade organization, safety organization or entity that sets applicable standards, in the United States, Canada, Mexico or any other applicable j...
Applicable Laws and Standards means all applicable state and federal laws, statutes, acts, regulations, rules, standards, policies, guidelines, conditions and judicial or administrative rulings, orders, or opinions. Such laws and standards include, but are not limited to: [insert citations to appropriate state statutes]; the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Pub. L. No. 104-191 (Aug. 21, 1996), 45 C.F.R. parts 160 and 164 (HIPAA Privacy and Security Rules); the federal confidentiality law and regulations, 42 U.S.C. § 290dd-2, 42 C.F.R. Part 2; standards of the Centers for Medicare and Medicaid Services Conditions of Participation; and standards of accrediting agencies such as the Joint Commission on Accreditation of Health care Organizations.
Applicable Laws and Standards means, in addition to the definition set forth in the Data Sharing Agreement, the federal Confidentiality of Alcohol and Drug Abuse Patient Records statute, section 543 of the Public Health Service Act, 42 U.S.C. 290dd-2, and its implementing regulation, 42 CFR Part 2; the Michigan Mental Health Code, at MCLA §§ 333.1748 and 333.1748a; and the Michigan Public Health Code, at MCL § 333.5131, 5114a.
Applicable Laws and Standards means all applicable federal, state, local, and foreign and international laws, rules, regulations, codes, constitutions, treaties, standards, requirements, guidance, bulletins, white papers, reports or similar communications of any Governmental Authority, including any administrative, self-regulatory, industry, trade or safety body, organization or entity, as may be amended and in effect and whether or not having the force of law related to the services or products of a PO.