Compliance with Quality Assurance and Quality System Regulations Sample Clauses

Compliance with Quality Assurance and Quality System Regulations. Supplier represents and warrants as follows: (a) the Manufacturing Processes used to produce the Products comply with all Applicable Laws, including GMPs, and have been validated in compliance with the FDA’s Quality System Regulations at 21 C.F.R. Part 820, (b) the Manufacturing Processes comply with ISO 900x or ISO 13485 series standard in the most current version, including all future changes and substitutions, and (c) the Manufacturing Processes comply with the requirements of European IVD directive (98/79/EC). Supplier further represents and warrants that Supplier shall maintain purchasing controls in accordance with all Applicable Laws, including but not limited to 21 C.F.R. Part 820.50, and shall establish and maintain procedures to ensure that Supplier’s subcontractors, vendors and manufacturers comply with all such Applicable Laws. Supplier shall provide RDR and RDO with any applicable validation certificates upon request. Supplier represents and warrants that an installation qualification, operational qualification, and performance qualification has been performed on all applicable aspects of the Manufacturing Processes. Without limiting the warranty in this Paragraph, Supplier guarantees that none of the Products, at the time of delivery, are adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 321-394) (the “Act”), or similar law of any other jurisdiction. All warranties and commitments set forth in this Paragraph shall be deemed to be made and given by Supplier on a continuing basis throughout the Term of this Agreement and until all of Supplier’s obligations have been satisfied.
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Compliance with Quality Assurance and Quality System Regulations. Supplier represents and warrants as follows: (a) the manufacturing processes used to produce its Products comply with all applicable laws. Supplier further represents and warrants that Supplier shall maintain purchasing controls in accordance with all applicable laws and shall establish and maintain procedures to ensure that Supplier’s subcontractors, vendors and manufacturers comply with all such applicable laws. Supplier shall provide Provider with any applicable validation certificates upon request. Supplier represents and warrants that an installation qualification, operational qualification, and performance qualification has been performed on the manufacturing processes for the Products in accordance with XX X. Without limiting the warranty in this Paragraph, Supplier warrants that none of its Products, at the time of delivery, are adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 321-394), or similar law of any other jurisdiction.

Related to Compliance with Quality Assurance and Quality System Regulations

  • Compliance with NASD Rules The Company hereby agrees that it will ensure that the Reserved Securities will be restricted as required by the National Association of Securities Dealers, Inc. (the "NASD") or the NASD rules from sale, transfer, assignment, pledge or hypothecation for a period of three months following the date of this Agreement. The Underwriters will notify the Company as to which persons will need to be so restricted. At the request of the Underwriters, the Company will direct the transfer agent to place a stop transfer restriction upon such securities for such period of time. Should the Company release, or seek to release, from such restrictions any of the Reserved Securities, the Company agrees to reimburse the Underwriters for any reasonable expenses (including, without limitation, legal expenses) they incur in connection with such release.

  • Compliance with Regulations Tenant shall not use the Premises in any manner which violates any Laws or Private Restrictions which affect the Premises. Tenant shall abide by and promptly observe and comply with all Laws and Private Restrictions. Tenant shall not use the Premises in any manner which will cause a cancellation of any insurance policy covering Tenant’s Alterations or any improvements installed by Landlord at its expense or which poses an unreasonable risk of damage or injury to the Premises. Tenant shall not sell, or permit to be kept, used, or sold in or about the Premises any article which may be prohibited by the standard form of fire insurance policy. Tenant shall comply with all reasonable requirements of any insurance company, insurance underwriter, or Board of Fire Underwriters which are necessary to maintain the insurance coverage carried by either Landlord or Tenant pursuant to this Lease.

  • Compliance with FINRA Rules The Company hereby agrees that it will ensure that the Reserved Securities will be restricted as required by FINRA or the FINRA rules from sale, transfer, assignment, pledge or hypothecation for a period of three months following the date of this Agreement. The Underwriters will notify the Company as to which persons will need to be so restricted. At the request of the Underwriters, the Company will direct the transfer agent to place a stop transfer restriction upon such securities for such period of time. Should the Company release, or seek to release, from such restrictions any of the Reserved Securities, the Company agrees to reimburse the Underwriters for any reasonable expenses (including, without limitation, legal expenses) they incur in connection with such release.

  • Compliance with SAFE Rules and Regulations Except as otherwise disclosed in Disclosure Package and the Prospectus, the Company has taken reasonable steps to cause the Company’s shareholders who are residents or citizens of the PRC, to comply with any applicable rules and regulations of the State Administration of Foreign Exchange (“SAFE”) relating to such shareholders’ shareholding with the Company (the “SAFE Rules and Regulations”), including, without limitation, taking reasonable steps to require each shareholder that is, or is directly or indirectly owned or controlled by, a resident or citizen of the PRC to complete any registration and other procedures required under applicable SAFE Rules and Regulations.

  • Compliance with Regulations T, U and X Neither the Borrower nor any of its Restricted Subsidiaries is engaged principally or as one of its important activities in the business of extending credit for the purpose of purchasing or carrying, and neither the Borrower nor any of its Restricted Subsidiaries owns or presently intends to acquire, any “margin security” or “margin stock” (the “Margin Stock”) as defined in Regulations T, U, and X (12 C.F.R. Parts 220, 221 and 224) of the Board of Governors of the Federal Reserve System (the “Fed Regulations”) which would result in any violation of the Fed Regulations. None of the proceeds of the Loans will be used, directly or indirectly, for the purpose of purchasing or carrying any Margin Stock or for the purpose of reducing or retiring any Indebtedness which was originally incurred to purchase or carry Margin Stock or for any other purpose which might constitute this transaction a “purpose credit” within the meaning of said Regulations, in each case which would result in any violation of the Fed Regulations. The Borrower has not taken, caused or authorized to be taken, and will not take any action which might cause this Agreement to violate any Fed Regulation or any other regulation of the Board of Governors of the Federal Reserve System or to violate the Securities Exchange Act of 1934, in each case as now in effect or as the same may hereafter be in effect. If so requested by the Administrative Agent, the Borrower will furnish the Administrative Agent with (i) a statement or statements in conformity with the requirements of the applicable Federal Reserve Forms referred to in Regulation U of said Board of Governors and (ii) other documents evidencing its compliance with the margin regulations, reasonably requested by the Administrative Agent. Neither the making of the Loans nor the use of proceeds thereof will violate, or be inconsistent with, the provisions of any Fed Regulation. Following the application of the proceeds of each Loan and Letter of Credit, not more than twenty-five percent (25%) of the value of the assets (either of the Borrower only or of the Borrower and its Restricted Subsidiaries on a consolidated basis) subject to the provisions of Section 7.2 or Section 7.4 or subject to any similar restriction contained in any agreement or instrument between the Borrower and any Lender or any Affiliate of any Lender relating to Indebtedness subject to Section 8.1(k) will be “Margin Stock”.

  • Compliance with Rules and Regulations PFPC undertakes to comply with all applicable requirements of the Securities Laws and any laws, rules and regulations of governmental authorities having jurisdiction with respect to the duties to be performed by PFPC hereunder. Except as specifically set forth herein, PFPC assumes no responsibility for such compliance by the Fund or any other entity.

  • Compliance with Rules and Policies The Executive shall perform all services in accordance with the lawful policies, procedures and rules established by the Company and the Board. In addition, the Executive shall comply with all laws, rules and regulations that are generally applicable to the Company or its subsidiaries and their respective employees, directors and officers.

  • Compliance With Insurance Requirements Borrower will comply with all Insurance requirements and will not permit any condition to exist on the Mortgaged Property that would invalidate any part of any Insurance coverage required under this Loan Agreement.

  • Compliance with Applicable Regulations In performing its duties hereunder, the Subadviser

  • Compliance with Rule 15c2-8 In the case of a Registered Offering and any other Offering to which the provisions of Rule 15c2-8 under the 1934 Act are made applicable pursuant to the AAU or otherwise, you will comply with such Rule in connection with the Offering. In the case of an Offering other than a Registered Offering, you will comply with applicable Federal and state laws and the applicable rules and regulations of any regulatory body promulgated thereunder governing the use and distribution of offering circulars by underwriters.

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