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 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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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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Examples of All Applicable Laws and Regulations in a sentence

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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Regardless of the aforementioned, Hollister-Stier remains responsible for cxxxxxxxxx xx xxiting that the Intermediate and Product (1) were manufactured according to Manufacturing Procedures and All Applicable Laws and Regulations and (2) meet the applicable Specifications.

  • Client at its discretion may have its representatives observe the performance of the Product Development Programs under this Agreement, including any equipment, facility or analytical qualification; manufacturing, inspection and bulk packaging activities to provide appropriate technical support and to ensure compliance with All Applicable Laws and Regulations.

  • As fiduciaries, the Adviser and CIM Personnel have an affirmative duty of care, loyalty, honesty and good faith to act in the best interests of Clients.·CIM Personnel Must Comply With All Applicable Laws and Regulations.


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.

  • Applicable law and regulations means the Federal Credit Union Act and rules and regulations issued thereunder or other applicable federal and state statutes and rules and regulations issued thereunder as the context indicates.

  • 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.

  • Applicable Laws/ Rules means the laws/ Rules of Islamic Republic of Pakistan/Punjab, as they may be issued and enforced from time to time.

  • 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.

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

  • Regulatory Requirements means all applicable federal and state statutes, regulations, regulatory guidance, judicial or administrative rulings, requirements of Governmental Contracts and standards and requirements of any accrediting or certifying organization, including, but not limited to, the requirements set forth in a Product Attachment.

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

  • Applicable Technical Requirements and Standards means those certain technical requirements and standards applicable to interconnections of generation and/or transmission facilities with the facilities of an Interconnected Transmission Owner or, as the case may be and to the extent applicable, of an Electric Distributor, as published by Transmission Provider in a PJM Manual provided, however, that, with respect to any generation facilities with maximum generating capacity of 2 MW or less (synchronous) or 5 MW or less (inverter-based) for which the Interconnection Customer executes a Construction Service Agreement or Interconnection Service Agreement on or after March 19, 2005, “Applicable Technical Requirements and Standards” shall refer to the “PJM Small Generator Interconnection Applicable Technical Requirements and Standards.” All Applicable Technical Requirements and Standards shall be publicly available through postings on Transmission Provider’s internet website.

  • EP Regulations means The Environmental Permitting (England and Wales) Regulations SI 2016 No.1154 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 Waukon, Iowa, as embodied in this Code of Ordinances, ordinances not repealed by the ordinance adopting this Code of Ordinances, and those enacted hereafter.

  • Trade Laws means, with respect to any Person, all applicable customs, import and export Laws in jurisdictions in which such Person or any of its Subsidiaries does business or is otherwise subject to jurisdiction.

  • 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 has the meaning provided in Section 5.19(a).

  • 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