Generic Drug Enforcement Act of 1992 Clause Examples

The Generic Drug Enforcement Act of 1992 is a legislative provision designed to prevent individuals or companies convicted of certain offenses related to drug approval or manufacturing from participating in the generic drug industry. In practice, this clause empowers the Food and Drug Administration (FDA) to debar, or ban, such parties from submitting new generic drug applications or working with companies that do. For example, if a manufacturer is found guilty of falsifying data in drug applications, they can be prohibited from future involvement in the generic drug approval process. The core function of this clause is to protect public health and ensure the integrity of the generic drug market by deterring fraud and misconduct.
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Generic Drug Enforcement Act of 1992. Consultant represents that it has never been (i) debarred or (ii) convicted of a crime for which a person can be debarred, under Section 306(a) or 306(b) of the Generic Drug Enforcement Action of 1992. Consultant represents that it has never been and, to the best of its knowledge after due inquiry, has ever been (a) threatened to be debarred or (b) indicted for a crime or otherwise engaged in conduct for which a person can be debarred, under Section 306(a) or (b). Consultant agrees that it will promptly notify each Client in the event of any such debarment, conviction, threat or indictment.
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Generic Drug Enforcement Act of 1992. Each party will comply at all times with the provisions of the United States Generic Drug Enforcement Act of 1992, as amended, and will upon request certify in writing to the other parties that none of its employees nor any person providing services in connection with this Agreement and/or involved in the manufacture, shipment, distribution or sale of any Product has been debarred under the provisions of such Act.
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Generic Drug Enforcement Act of 1992. UNIVERSITY represents that the UNIVERSITY is not debarred. The UNIVERSITY will not knowingly use in any capacity the services of any person debarred under subsection 306(A) or 306(B) of the Generic Drug Enforcement Act of 1992 in connection with any of the services performed by UNIVERSITY for this study hereunder. UNIVERSITY will immediately disclose in writing to SPONSOR if any person who is performing services to this study hereunder is debarred or if any debarment action, suit, claim, investigation, legal or administrative proceeding is pending or, to the best of UNIVERSITY'S knowledge, threatened, relating to the debarment of UNIVERSITY or any person performing services for this study hereunder.
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Generic Drug Enforcement Act of 1992. BEL represents that it has never been debarred or convicted of a crime for which a person can be debarred, under Section 335a or 335b of the Generic Drug Enforcement Act of 1992 (Section 335a or 335b). BEL further represents that it has never been threatened to be debarred or indicted for a crime or otherwise engaged in conduct for which a person can be debarred, under Section 335a or b. BEL agrees to promptly notify URGP in the event of any such debarment, conviction, threat or indictment.
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Generic Drug Enforcement Act of 1992. Genzyme represents to the best of its knowledge that it and its employees have never been (i) debarred or (ii) convicted of a crime for which a person can be debarred, under Section 306(a) or 306(b) of the Generic Drug Enforcement Action of 1992. Genzyme represents that it has never been and, to the best of its knowledge, none of its employees, affiliates or agents has ever been (a) threatened to be debarred or (b) indicted for a crime or otherwise engaged in conduct for which a person can be debarred, under Section 306(a) or (b). Genzyme agrees that it will promptly notify Discovery in the event it becomes aware of any such debarment, conviction, threat or indictment.
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Generic Drug Enforcement Act of 1992. Averion represents that it and its employees, affiliates and agents have never been (i) debarred or (ii) convicted of a crime for which a person can he debarred under Section 306(a) or 306(b) of the Generic Drug Enforcement Action of 1992. Averion represents that it has never been and, to the best of its knowledge after due inquiry, none of its employees, affiliates, or agents has ever been (1) threatened to be debarred or (2) indicted for a crime or otherwise engaged in conduct for which a person can be debarred, under Section 306(a) or (b). Averion agrees that it will promptly notify Client in the event of any such debarment, conviction, threat or indictment. Assignment Neither party shall assign this MSA or any Work Assignment/Change Order without the prior written consent of the other party; provided, however a party may assign this MSA or any Work Assignment/Change Order without prior consent in the event of the sale of its business. Non-Waiver The waiver, forbearance or failure by either party to claim a breach of any provision of this MSA or any Work Assignment or Change Order pursuant hereto, or to exercise any right or remedy provided by this MSA, shall not be deemed to constitute a modification of any provision of this MSA, or a waiver or estoppel with respect to any subsequent breach or with respect to any provision thereof. Changes and Modifications No changes or modifications of this MSA or any Work Assignment or Change Order shall be deemed effective unless in writing and executed by the parties hereto.
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Generic Drug Enforcement Act of 1992. Institution represents that it has never been and, to the best of its knowledge after reasonable inquiry, its employees, affiliates, and agents have never been 1) debarred or 2) convicted of a crime for which a person can be debarred, under Section 306(a) or 306(b) of the Generic Drug Enforcement Act of 1992 ("Section 306(a) or (b)"). Institution represents that it has never been and, to the best of its knowledge, after our inquiry, none of its employees, affiliates, or agents has ever been 1) threatened to be debarred or 2) indicted for a crime or otherwise engaged in conduct for which a person can be debarred, under Section 306(a) or (b). Institution agrees that it will promptly notify Warner in the event of any such debarment, conviction, threat, or indictment. The terms of the preceding sentence shall survive the termination or expiration of this Agreement.
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Generic Drug Enforcement Act of 1992. Vendor represents that it and its employees have never been (i) debarred or (ii) convicted of a crime for which a person can be debarred, under Section 306(a) or 306(b) of the Generic Drug Enforcement Action of 1992. Vendor represents that it has never been and, to the best of its knowledge after due inquiry, none of its employees, affiliates or agents has ever been (a) threatened to be debarred or (b) indicted for a crime or otherwise engaged in conduct for which a person can be debarred, under Section 306(a) or (b). Vendor agrees that it will promptly notify IMCOR in the event of any such debarment, conviction, threat or indictment.
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Related to Generic Drug Enforcement Act of 1992

  • OMNIBUS PROCUREMENT ACT OF 1992 It is the policy of New York State to maximize opportunities for the participation of New York State business enterprises, including minority and women-owned business enterprises as bidders, subcontractors and suppliers on its procurement contracts. Information on the availability of New York State subcontractors and suppliers is available from: NYS Department of Economic Development Division for Xxxxx Xxxxxxxx Xxxxxx, Xxx Xxxx 00000 Telephone: 000-000-0000 Fax: 000-000-0000 email: [email protected] A directory of certified minority and women-owned business enterprises is available from: NYS Department of Economic Development Division of Minority and Women's Business Development 000 Xxxxx Xxxxxx Xxx Xxxx, XX 00000 212-803-2414 email: [email protected] xxxxx://xx.xxxxxxxxxxxxxx.xxx/FrontEnd/VendorSearchPu blic.asp The Omnibus Procurement Act of 1992 requires that by signing this bid proposal or contract, as applicable, Contractors certify that whenever the total bid amount is greater than $1 million: (a) The Contractor has made reasonable efforts to encourage the participation of New York State Business Enterprises as suppliers and subcontractors, including certified minority and women-owned business enterprises, on this project, and has retained the documentation of these efforts to be provided upon request to the State; (b) The Contractor has complied with the Federal Equal Opportunity Act of 1972 (P.L. 92-261), as amended; (c) The Contractor agrees to make reasonable efforts to provide notification to New York State residents of employment opportunities on this project through listing any such positions with the Job Service Division of the New York State Department of Labor, or providing such notification in such manner as is consistent with existing collective bargaining contracts or agreements. The Contractor agrees to document these efforts and to provide said documentation to the State upon request; and (d) The Contractor acknowledges notice that the State may seek to obtain offset credits from foreign countries as a result of this contract and agrees to cooperate with the State in these efforts.

  • Federal Regulations No part of the proceeds of any Loans will be used for "purchasing" or "carrying" any "margin stock" within the respective meanings of each of the quoted terms under Regulation U as now and from time to time hereafter in effect or for any purpose that violates the provisions of the Regulations of the Board. If requested by any Lender or the Administrative Agent, the Borrower will furnish to the Administrative Agent and each Lender a statement to the foregoing effect in conformity with the requirements of FR Form G-3 or FR Form U-1 referred to in Regulation U.

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