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.
Source 1Source 2Source 3
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.
Source 1Source 2
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.
Source 1Source 2

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 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 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.

  • 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 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.

  • 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.

  • If, after such audit is conducted it is determined that Contractor has failed to meet its material obligations under this Agreement or has failed to materially comply with All Applicable Laws and Regulations, Contractor shall reimburse LSC for all commercially reasonable audit costs, including, but not limited to, all travel costs and professional fees incurred to conduct such audit(s).


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.
Source 1

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: (i) any legislation, regulation, by-law or subordinate legislation in force from time to time to which a party is subject and/or in any jurisdiction that the Goods and Services are provided to or in respect of; (ii) any binding court order, judgment or decree; (iii) any applicable industry code, policy or standard; or (iv) any applicable direction, policy, rule or order that is binding on a Party and that is made or given by any regulatory body having jurisdiction over a Party or any of that Party’s assets, resources or business.

  • 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.