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, 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 requirements may be amended or reenacted from time to time.
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

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.

  • Hollister-Stier shall ensure that all Chemicals and Materials supplied by Hollister-Stier on behalf of the Manufacturing Program (as may be set forth in Exhibit 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 of the Intermediate 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.

  • 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.

  • 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.

  • Client shall ensure that all Chemicals and Materials supplied to Hollister-Stier by or on behalf of Client (as may be set forth in Exhibit 1 of this 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.

  • 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 perform the "CTM Program" for Client related to Clinical Phase III supplies of the Intermediate and Product in compliance with All Applicable Laws and Regulations.

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 any and all applicable current or future laws, rules, regulations, ordinances, codes, orders and permits of any and all federal, state and local governmental and quasi-governmental bodies, agencies, authorities and courts having jurisdiction.

  • 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 or requirements imposed by, or based upon the obligations or authorities set forth in, (a) the USA PATRIOT Act, the Executive Order No. 13224 of September 23, 2001, entitled Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten to Commit, or Support Terrorism (66 Fed. Reg. 49079 (2001)), the U.S. International Emergency Economic Powers Act (50 U.S.C. §§ 1701 et seq.), the U.S. Trading with the Enemy Act (50 U.S.C. App. §§ 1 et seq.), the U.S. Syria Accountability and Lebanese Sovereignty Act, the U.S. Comprehensive Iran Sanctions, Accountability, and Divestment Act of 2010 or the Iran Sanctions Act, Section 1245 of the National Defense Authorization Act of 2012, all as amended, or any of the foreign assets control regulations (including but not limited to 31 C.F.R., Subtitle B, Chapter V, as amended) or any other law or executive order relating thereto administered by the U.S. Department of the Treasury Office of Foreign Assets Control or the U.S. Department of State, and any similar law, regulation, or executive order enacted in the United States after the date of this Agreement and (b) by a government of Canada pursuant to Canadian Economic Sanctions and Export Control Laws.

  • Legal Requirements means, with respect to the Property, all federal, state, county, municipal and other governmental statutes, laws, rules, orders, regulations, ordinances, judgments, decrees and injunctions of Governmental Authorities affecting the Property or any part thereof, or the construction, use, alteration or operation thereof, or any part thereof, whether now or hereafter enacted and in force, and all permits, licenses and authorizations and regulations relating thereto, and all covenants, agreements, restrictions and encumbrances contained in any instruments, either of record or known to Borrower, at any time in force affecting the Property or any part thereof, including, without limitation, any which may (a) require repairs, modifications or alterations in or to the Property or any part thereof, or (b) in any way limit the use and enjoyment thereof.

  • 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.

  • PPPFA Regulations means the Preferential Procurement Regulations, 2017 published in terms of the PPPFA.

  • Regulatory Requirements means all applicable statutes, statutory instruments, orders, regulations and codes of practice (whether or not having the force of law) in force from time to time, and in particular but without limitation the requirements, rules, regulations, guidance and codes of practice of FSMA and the relevant regulator;

  • other applicable legislation means any other legislation applicable to municipal supply chain management, including –

  • EP Regulations means The Environmental Permitting (England and Wales) Regulations SI 2010 No.675 and words and expressions used in this permit which are also used in the Regulations have the same meanings as in those Regulations.

  • 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 Grimes, Iowa, as embodied in the Code of Ordinances, ordinances not repealed by the ordinance adopting the 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 applicable Laws relating to the possession, control, warehousing, marketing, sale and distribution of pharmaceuticals, the operation of medical or senior housing facilities (such as, but not limited to, nursing homes, skilled nursing facilities, rehabilitation hospitals, intermediate care facilities, assisted living and adult care facilities), patient healthcare, patient healthcare information, patient abuse, the quality and adequacy of medical care, rate setting, equipment, personnel, operating policies, fee splitting, including, without limitation, (a) all federal and state fraud and abuse laws, including, but not limited to the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(6)), the Stark Law (42 U.S.C. §1395nn), the civil False Claims Act (31 U.S.C. §3729 et seq.); (b) TRICARE; (c) CHAMPUS, (d) Medicare; (e) Medicaid; (f) HIPAA; (g) quality, safety and accreditation standards and requirements of all applicable state laws or regulatory bodies; (h) all laws, policies, procedures, permits, requirements, certifications, and regulations pursuant to which licenses, approvals and accreditation certificates are issued in order to operate medical, senior housing facilities, assisted living facilities, or skilled nursing facilities; and (i) any and all other applicable health care laws, regulations, manual provisions, policies and administrative guidance, each of (a) through (i) as may be amended from time to time.

  • 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 guidance 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.

  • Medicare Regulations means, collectively, all federal statutes (whether set forth in Title XVIII of the Social Security Act or elsewhere) affecting Medicare, together with all applicable provisions of all rules, regulations, manuals and orders and administrative, reimbursement and other guidelines having the force of law of all Governmental Authorities (including without limitation, Health and Human Services (“HHS”), Centers for Medicare and Medicaid Services, the Office of the Inspector General for HHS, or any Person succeeding to the functions of any of the foregoing) promulgated pursuant to or in connection with any of the foregoing having the force of law, as each may be amended or supplemented.