Product Compliance. Supplier represents and warrants to Novation, the Clients and the Members that the Products are, if required, registered, and will not be distributed, sold or priced by Supplier in violation of any federal, state or local law. Supplier represents and warrants that as of the date of delivery to the Members all Products will not be adulterated or misbranded within the meaning of the Federal Food, Drug and Cosmetic Act and will not violate or cause a violation of any applicable law, ordinance, rule, regulation or order. Supplier agrees it will comply with all applicable Good Manufacturing Practices and Standards contained in 21 C.F.R. Parts 210, 211, 225, 226, 600, 606, 610, 640, 660, 680 and 820. Supplier represents and warrants that it will provide adequate warnings and instructions to inform users of the Products of the risks, if any, associated with the use of the Products. Supplier's representations; warranties and agreements in this Subsection will survive the expiration or earlier termination of this Agreement.
Product Compliance. Seller hereby certifies that any Product delivered under this Agreement is in compliance with the standards applicable to the delivery location when delivered to the Buyer. For each delivery of gasoline, Seller shall provide to Buyer a certificate of analysis, a xxxx of lading, a delivery ticket, or a loading ticket that certifies that the gasoline is in compliance with federal and state Xxxx Vapor Pressure requirements applicable at the time of delivery. For each delivery of reformulated and conventional gasoline, Seller shall provide a product transfer document containing the information required under federal regulations, specifically 40 C.F.R. sections 80.77, 80.106, 80.158, and 80.171 as such regulations may be modified from time to time.
Product Compliance. Product delivered to Customer pursuant to this Agreement shall conform to the Specification and be in compliance with all Applicable Law, including but not limited to the requirements of cGMP. Customer acknowledges that it is aware that in May 2011 and November 2011, BVL’s manufacturing facility was inspected by the United States Food and Drug Administration and by the European Medicines Agency in March 2011 and November 2011. Customer further acknowledges that each of these inspections resulted in observations from the regulatory authority citing deviations from current Good Manufacturing Practices. Customer acknowledges The European Medicines Agency and the Therapeutic Goods Administration have issued BVL short-dated, restricted GMP licenses. Customer further acknowledges that it is aware BVL voluntarily suspended manufacturing at its site as of November 2011. Customer has reviewed the records of inspection from the above mentioned regulatory authorities as well as BVL’s corrective action responses to the regulatory agencies and is satisfied that the corrective actions set forth in BVL’s corrective action plan should rectify the cGMP issues at the manufacturing facility that directly or indirectly affect Customer’s Products. Based on the foregoing, Customer acknowledges that the GMP issues set forth above, as well as any prior deviations from cGMP by BVL, shall not constitute grounds for a claim of any breach of this Agreement, and Customer specifically waives any right to claim any breach under this Agreement based on any such prior deviations from cGMP. In the event of conflicting Applicable Law, Product will comply with the most stringent from the conflicting requirements unless otherwise agreed to by the Parties.
Product Compliance. All materials, substances, parts and components used by Seller shall conform to the following (including any future revision of the following): (a) the Registration, Evaluation, Authorization and Restriction of Chemicals (“REACh”) Regulation EC 1907/2007;
Product Compliance. 27 4.1 Reliability and Service Availability.........................................27 4.2
Product Compliance. Product delivered to Customer pursuant to this Agreement shall conform to the Specifications and shall have been Manufactured in compliance with all Applicable Law, including but not limited to the requirements of cGMP, and shall not be contaminated, adulterated or misbranded. In the event of conflicting Applicable Law, Product will comply with United States cGMP requirements unless otherwise agreed to by the Parties.
Product Compliance. Seller represents and warrants that all Products comply with all applicable federal, state, and local laws, codes, statutes, ordinances, rules, regulations, and requirements of any applicable jurisdiction, and orders of any governmental or regulatory authority, including but not limited to the California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65); the Consumer Product Safety Act of 1972 (as amended by the Consumer Product Safety Improvement Act of 2008); the Xxxxxxxx-Xxxx Warranty Federal Trade Commission Improvement Act; the Fair Packaging and Labeling Act; the Textile Fiber Products Identification Act; the Flammable Fabrics Act; the Wool Products Labeling Act; the Federal Food, Drug, and Cosmetic Act; the Toxic Substances Control Act; the Federal Hazardous Substances Act; the Energy Policy and Conservation Act and any amendments thereto; all applicable rules and regulations regarding maximum volatile organic compound content and associated markings; all applicable rules and regulations regarding fees, assessments, and recordkeeping requirements associated with the sale of pesticides; all applicable rules and regulations of the Federal Trade Commission and the U.S. Food and Drug Administration, and all applicable rules and regulations of any other federal, state, or local agency (collectively, the "Law" or the "Laws"), and that any changes to goods hereafter made by Seller shall comply with all applicable Laws.
Product Compliance. Each Party shall make commercially reasonable efforts to comply, at its own expense, with all legal requirements that apply to such Party’s obligations under this Agreement. In connection therewith the Parties shall reasonably cooperate with the other Party in the provision of information required to comply with each other party’s respective legal requirements. In the event there are any changes of the legal requirements or new legal requirements after the date hereof, each Party will use commercially reasonable efforts to comply with such changes or new legal requirements, as applicable to each such Party.
Product Compliance. Section 3.23 of the Seller Letter identifies each product recall, market withdrawal, stock recovery or service bulletin (collectively, “Recall”) (whether voluntary or compulsory) and the circumstances surrounding each Recall, involving any products of the Business since May 1, 2005 and prior to the date of this Agreement. Since May 1, 2005 the Business has maintained accurate sales records, order backlog and other information with respect to all products and services. No product currently manufactured, sold, leased, licensed or delivered by the Business is subject to a Recall required by any Governmental Entity and the Business has no plans to initiate a voluntary Recall. To the knowledge of the Seller, each type of product manufactured, sold, leased, licensed or delivered by the Business conforms in all material respects with all applicable Laws in effect at the time of such manufacture, sale, lease, license or delivery. The Business has complied with all applicable rules, regulations and reporting requirements currently in effect of the United States Food and Drug Administration, the United States Department of Agriculture, the Federal Trade Commission, the United States Consumer Product Safety Commission, and the United States Environmental Protection Agency and any comparable foreign Governmental Entity.
Product Compliance iDEN SUBSCRIBER EQUIPMENT shall be existing iDEN subscriber products commercially available as of the Effective Date and shall comply with their applicable technical specifications, marketing literature, and user guides, in all material respects.
