Regulatory Compliance Requirements Sample Clauses

Regulatory Compliance Requirements. The A-E shall not be entitled to any time extensions or compensation for any cost due to any action required as a result of the A-E’s failure to comply with those provisions within the A-E’s control as listed below. The A-E shall be responsible for ensuring that the A-E’s subcontractor(s) and Team Member(s) comply with the provisions of this Section. The A-E shall be liable for any action or inaction resulting in a fine imposed by the regulatory agencies on those incidents of noncompliance that is within the A-E’s area of responsibility.
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Regulatory Compliance Requirements. Distributor shall meet all regulatory requirements as outlined in this section:
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Regulatory Compliance Requirements. In addition to the terms of this agreement, you agree to comply with all laws, statutes, regulations and ordinances pertaining to your use of RDC, as well as laws relating to banking transactions. You also agree to abide by any clearinghouse rules or agreements, image exchange agreements and to hold Credit Union harmless from any loss, damages, liabilities, costs or expenses resulting from a violation of any of the above. Your agreement remains in effect until all RDC images have been successfully processed, without regard to whether or not your account with Credit Union is open or closed.
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Regulatory Compliance Requirements. All County Contracting shall comply with 2 CFR, Part 200 and legislation for the regulation of labor, safety and environmental protection, emergency preparedness and advisories, and any other codified criteria including but not limited to the following as relevant to this Contract: Remedies:
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Regulatory Compliance Requirements. Distributor shall meet all regulatory requirements as outlined in this section: (a) Distributor will market the Products only in countries where regulatory compliance has been confirmed, (b) Distributor will determine requirements for sale of the Products as prescriptive devices in targeted markets. Distributor will document these requirements and inform Company prior to distribution into each country, (c) Distributor will maintain shipping records of all the Products that are distributed, (d) All customer complaints will be informed immediately to Company, and (e) In case of adverse medical events involving the Products, Distributor will submit to Company all information to evaluate applicable regulatory reporting requirements. All complaints shall be reviewed by Company and filed by Company should the results of Company's complaint investigation deem the complaint to meet the criteria of a reportable event. Company shall have sole responsibility for reporting of any complaints or incidents to competent governmental authorities and Distributor shall not make any such [***] Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. report without the Company's prior written approval. Distributor will comply with Company instructions in case of a need for product advisory product recall of the Products. Distributor will maintain all documentation and records referred above for at least seven years. Record will be made available to Company upon request.
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Regulatory Compliance Requirements. Auxilium and Xxxxxxxxx-Xxxxx shall be in compliance with the following regulations and guidelines. The parties agree to work together in good faith to resolve any differences in interpretation of the regulations.
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Regulatory Compliance Requirements. Dyax and Xxxxxxxxx-Xxxxx shall be in compliance with the following regulations and guidelines. The Parties agree that compliance with certain of the regulations is a matter of interpretation and that the Parties will work together in good faith to resolve any differences in interpretation of the regulations.
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Regulatory Compliance Requirements. Licensee and VIVUS shall operate in compliance with all applicable laws, now in effect or hereinafter established, relating in any manner to the processing, Manufacturing, packaging, testing, inspection, storing, handling, delivery, shipping and disposal of the product. Further, Licensee and VIVUS shall at all times be in compliance with the following regulations and guidelines, as amended from time to time and if applicable:
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Regulatory Compliance Requirements 
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Related to Regulatory Compliance Requirements

  • Regulatory Compliance a. Monitor compliance with the 1940 Act requirements, including:

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

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