All Applicable Laws and Regulations definition

All Applicable Laws and Regulations means all Federal, state and local laws and regulations and, where applicable, guidance documents promulgated by the FDA and being currently utilized within the pharmaceutical industry to manufacture the applicable type of products(s) that apply to the Services being provided hereunder by Hollister-Stier, including, but not limited to, the Federal Food, Drxx, xxx Xxxxxxxc Act (the "Act") as amended, and the regulations promulgated thereunder, and the requirements of other domestic or foreign governmental authorities made known to Hollister-Stier by Client, as all of such laws, regulations or requixxxxxxx xxx xx amended or reenacted from time to time.
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All Applicable Laws and Regulations means all Federal, State, and Local laws and regulations and, where applicable, guidance documents promulgated by the FDA and being currently utilized within the pharmaceutical industry to manufacture the applicable type of Intermediate(s) and Product(s) that apply to the services being provided hereunder by Hollister-Stier, including but not limited to , thx Xxxxxxx Xxxx Drug, and Cosmetic Act (the "Act") as amended, and the regulations promulgated thereunder, and the requirements of other domestic or foreign governmental authorities made known to Hollister-Stier by Client, as all of such laws, regulations or xxquirements may be amended or reenacted from time to time.
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All Applicable Laws and Regulations means applicable federal, state, provincial and local laws, orders, ordinances, policies, regulations, rules and guidelines of any countries (including but not limited to the United States and the European Union) having authority over any clinical studies conducted hereunder, the use or review of data obtained as a result of such clinical studies, or the activities of Ergomed in providing Services under this Agreement. For clinical studies conducted under an investigational new drug application and investigational device exemption filed in the United States, Applicable Laws include, without limitation, 21 CFR Pts. 312, 812, 50, 54, and 56, the FDA's Electronic Records and Electronic Signatures Guidance (21 CFR Pt. 11), and the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations (45 CFR Pts. 160 and 164) ("HIPAA"), as amended from time to time. For studies conducted in, or for use in an application for marketing in the European Union or in any Member State of the European Union, Applicable Laws and Regulations include, but are not limited to the Clinical Trials Directive (2001/20/EC), The Medical Device Directive (93/42/EEC), the EU Good Clinical Practice Guideline (Directive 2005/28/EC), and the Personal Data Directive (95/46/EC). Applicable Laws and Regulations also include all conditions of approval imposed by the reviewing IRB/Ethics Committees, FDA and other applicable authorities, ICH guidelines (including the "Good Clinical Practice: Consolidated Guideline") and the ethical principles contained in the Declaration of Helsinki, as set forth in 21 CFR Section 312.120(c)(4), as amended from time to time.
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Examples of All Applicable Laws and Regulations in a sentence

  • Subject to All Applicable Laws and Regulations (Section 23B.56.040)The approved use and/or construction is subject to, and shall comply with, all applicable City Ordinances and laws and regulations of other governmental agencies.

  • Applicable Laws and Regulations: All Applicable Laws and Regulations of the United Kingdom and the prevailing regulations, requirements, determination, practice and guidelines of the FCA in the United Kingdom (or any regulatory authority that may succeed or replace it) or of any other governmental or regulatory organisation to which You and TUTMAN are subject, including the FCA Rules, in each case as amended from time to time.

  • Compliance with All Applicable Laws and Regulations The Developer will comply with all Applicable Laws and Regulations, including all approvals, authorizations, orders, and permits issued by any Governmental Authority; all Applicable Reliability Requirements, and all applicable Transmission Owner Technical Standards in the performance of its obligations under this Agreement.

  • Each Party shall comply with All Applicable Laws and Regulations in connection with the performance of this Agreement.

  • Client has a commercial interest in the manufacture of PLGA Microspheres and AI-700 (hereinafter respectively the "Intermediate" and the "Product") and is desirous of utilizing the services of Hollister-Stier in a phased program whereby Hollister-Stier will perxxxx xxx "XXX Xrogram" for Client related to Xxxxxxxx Xxxxx III supplies of the Intermediate and Product in compliance with All Applicable Laws and Regulations.

  • Client at its discretion may have its representatives observe any performance of the CTM Program, including any equipment, facility, qualification, analytical, manufacturing, inspection and bulk packaging activities to provide appropriate technical support and to ensure compliance with All Applicable Laws and Regulations.

  • Hollister-Stier shall ensure that all Chemicals and Materials supplixx xx Xxxxxxxxx-Stier on behalf of the Manufacturing Program (as may be sex xxxxx xx Xxxxbit 1 of this Agreement) are suitable for use under this Manufacturing Agreement, comply with All Applicable Laws and Regulations (including without limitation those relating to the import of such materials) and receive all required governmental and regulatory approvals, including without limitation customs and FDA approvals.

  • Before authorizing shipment of any batch of the Product, Hollister-Stier shall conduct and complete quality control testing ox xxx Xxxxxxxxxate and Product as set forth in Exhibit 1 and 2 hereto and ensure that the Batches: (i) were manufactured and tested in accordance with the Master Batch Production and Control Records, Master Quality Control analytical testing methods and All Applicable Laws and Regulations and (ii) meet applicable Specifications.

  • REPRESENTATIONS, WARRANTIES AND COVENANTS12.1. General12.2. Good Standing12.3. Authority12.4. No Conflict12.5. Consent and Approval12.6. Compliance with All Applicable Laws and Regulations ARTICLE 13.

  • Client shall ensure that all Chemicals and Materials supplied to Hollister-Stier by or on behalf of Client (as may be set forth in Exxxxxx 0 xx xxxx Agreement) are suitable for use under this Agreement, comply with All Applicable Laws and Regulations (including without limitation those relating to the import of such materials) and receive all required governmental and regulatory approvals, including without limitation customs and FDA approvals.


More Definitions of All Applicable Laws and Regulations

All Applicable Laws and Regulations means all federal, state, provincial, or local laws of the United States, United Kingdom and European Union member states having authority over the conduct of clinical studies, or the use or review of data obtained under this Agreement, or that govern the activities of Contractor in providing Services under this Agreement. For studies conducted under an investigational new drug application ("IND") in the United States, applicable laws and regulations may include, but are not limited to, 21 CFR Pts. 312, 50, and 56, FDA's Electronic Records and Electronic Signatures Rule (21 CFR Pt. 11), and the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") and its implementing regulations (45 CFR Pts. 160 and 164). For studies conducted in, or for use in an application for marketing approval submitted to a European Union member state, applicable laws may include, but are not limited to 65/65/EEC, 75/318/EEC, and 91/507/EEC, and the European Union Personal Data Directive ("Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data"). All Applicable Laws and Regulations also means all conditions of approval imposed by the reviewing IRB/Ethics Committees, FDA, or other applicable authorities.
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Related to All Applicable Laws and Regulations

  • Applicable Laws and Regulations means all duly promulgated applicable federal, State and local laws, regulations, rules, ordinances, codes, decrees, judgments, directives, or judicial or administrative orders, permits and other duly authorized actions of any Governmental Authority having jurisdiction over the relevant parties, their respective facilities, and/or the respective services they provide.

  • Laws and Regulations means federal, state, local and foreign statutes, laws, ordinances, regulations, rules, codes, orders, constitutions, treaties, principles of common law, judgments, decrees or other requirements;

  • Applicable Laws means the requirements relating to the administration of equity-based awards under U.S. state corporate laws, U.S. federal and state securities laws, the Code, any stock exchange or quotation system on which the Common Stock is listed or quoted and the applicable laws of any foreign country or jurisdiction where Awards are, or will be, granted under the Plan.

  • Data Protection Laws and Regulations means all laws and regulations, including laws and regulations of the European Union, the European Economic Area and their Member States, Switzerland and the United Kingdom, applicable to the Processing of Personal Data under the Agreement.

  • Sanctions Laws and Regulations means any sanctions, prohibitions or requirements imposed by any executive order (an “Executive Order”) or by any sanctions program administered by OFAC.

  • Legal Requirements means any federal, state, local, municipal, foreign or other law, statute, constitution, principle of common law, resolution, ordinance, code, order, edict, decree, rule, regulation, ruling or requirement issued, enacted, adopted, promulgated, implemented or otherwise put into effect by or under the authority of any Governmental Entity.

  • SAFE Rules and Regulations means collectively, the Circular 37 and any other applicable SAFE rules and regulations.

  • Bye-laws means the bye-laws of the Company, as amended from time to time.

  • TUPE Regulations means the Transfer of Undertakings (Protection of Employment) Regulations 2006, as amended.

  • Regulatory Requirements means all applicable laws, rules, regulations, orders, requirements, guidelines, interpretations, directives and requests (whether or not having the force of law) from and of, and plans, memoranda and agreements with, any Regulatory Authority.

  • CSD Regulations means the CSD’s rules and regulations applicable to the Issuer, the Agent and the Notes from time to time.

  • Ordinances means the ordinances of the City of Polk City, Iowa, as embodied in this Code of Ordinances, ordinances not repealed by the ordinance adopting this Code of Ordinances, and those enacted hereafter.

  • Applicable Regulations As to any Mortgage Loan, all federal, state and local laws, statutes, rules and regulations applicable thereto.

  • HIPAA Regulations means the regulations promulgated under HIPAA by the United States Department of Health and Human Services, including, but not limited to, 45 C.F.R. Part 160 and 45 C.F.R. Part 164.

  • Healthcare Laws means all Laws of any Jurisdiction relating to the governance or provision of healthcare services or the operation of healthcare facilities, and any rules and regulations adopted and publications promulgated pursuant thereto, including, without limitation, any Laws, rules and regulations relating to obtaining or the maintenance of certificates of need, licenses, permits, authorizations, certificates, and the unauthorized practice of medicine.

  • SEBI Regulations means the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015 together with the circulars issued thereunder, including any statutory modification(s) or re-enactment(s) thereof for the time being in force.

  • Regulations means the Income Tax Regulations promulgated under the Code, as such regulations may be amended from time to time (including corresponding provisions of succeeding regulations).

  • Governmental Regulations means all statutes, ordinances, rules and regulations of the Authorities applicable to Seller or the use or operation of the Real Property or the Improvements or any portion thereof.

  • UCITS Regulations means the European Communities Undertakings for Collective Investment in Transferable Securities) Regulations, 2011 (S.I. No. 352 of 2011) (as amended consolidated or substituted from time to time) and any regulations or notices issued by the Central Bank pursuant thereto for the time being in force.

  • TRADES Regulations means the regulations of the United States Department of the Treasury, published at 31 C.F.R. Part 357, as amended from time to time. Unless otherwise defined herein, all terms defined in the TRADES Regulations are used herein as therein defined.

  • Health Care Laws means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.), the Public Health Service Act (42 U.S.C. §§ 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated pursuant to such statutes; (iii) Medicare (Title XVIII of the Social Security Act); (iv) Medicaid (Title XIX of the Social Security Act); (v) the Controlled Substances Act (21 U.S.C. §§ 801 et seq.) and the regulations promulgated thereunder; and (vi) any and all other applicable health care laws and regulations. Neither the Company nor, to the knowledge of the Company, any subsidiary has received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Neither the Company nor, to the knowledge of the Company, any subsidiary is a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, its Subsidiaries nor any of its respective employees, officers or directors has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion.

  • FHA Regulations Regulations promulgated by HUD under the National Housing Act, codified in 24 Code of Federal Regulations, and other HUD issuances relating to FHA Loans, including the related handbooks, circulars, notices and mortgagee letters.