Debiotech Compliance Sample Clauses

Debiotech Compliance. If DEBIOTECH complies with such IMED Activation Request, the Parties shall follow such course of action to conclusion and DEBIOTECH shall have a period of up to six (6) months from and after receipt of the IMED Activation Request to have such second source producing an adequate supply. In the event that DEBIOTECH determines to comply with IMED's request against its better judgment, it may promptly deliver a written notice to IMED indicating the date by which it believed in its reasonable judgment that the primary source would have been producing an adequate supply. In the event that such notice was provided to IMED and the primary source was able to cure the Supply Failure prior to the date six (6) months after the IMED Activation Request, DEBIOTECH shall be entitled to an additional grace period under the liquidated damage provisions of Article 8.6 hereof equal to the number of days between (x) the date of receipt of the IMED Activation Request and (y) the date three (3) months after the Supply Interruption Notice.
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Debiotech Compliance. If DEBIOTECH complies with such IMED Activation Request, the Parties shall follow such course of action to conclusion and DEBIOTECH shall have a period of up to [CONFIDENTIAL TREATMENT REQUESTED] from and after receipt of the IMED Activation Request to have such second source producing an adequate supply. In the event that DEBIOTECH determines to comply with IMED's request against its better judgment, it may promptly deliver a written notice to IMED indicating the date by which it believed in its reasonable judgment that the primary source would have been producing an adequate supply. In the event that such notice was provided to IMED and the primary source was able to cure the Supply Failure prior to the date [CONFIDENTIAL TREATMENT REQUESTED] after the IMED Activation Request, DEBIOTECH shall be entitled to an additional grace period under the liquidated damage provisions of Article 8.6 hereof equal to the number of days between (x) the date of receipt of the IMED Activation Request and (y) the date [CONFIDENTIAL TREATMENT REQUESTED] after the Supply Interruption Notice.
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Related to Debiotech Compliance

  • FDA Compliance The Company: (A) is and at all times has been in material compliance with all statutes, rules or regulations of the FDA and other comparable governmental entities applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Laws”); (B) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any governmental entity alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such Authorizations; (D) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA or any governmental entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) has not received notice that the FDA or any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity is considering such action; and (F) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).

  • Millennium Compliance Borrower shall take all action necessary to assure that there will be no material adverse change to Borrower's business by reason of the advent of the year 2000, including without limitation that all computer-based systems, embedded microchips and other processing capabilities effectively recognize and process dates after April 1, 1999, except for personal office computers and network stations which will be compliant by October 1, 1999. At FINOVA's request, Borrower shall provide to FINOVA assurance reasonably acceptable to FINOVA that Borrower's computer-based systems, embedded microchips and other processing capabilities are year 2000 compatible.

  • FCPA Compliance The Company has not and, to the best of the Company’s knowledge, none of its employees or agents at any time during the last five years have (i) made any unlawful contribution to any candidate for foreign office, or failed to disclose fully any contribution in violation of law, or (ii) made any payment to any federal or state governmental officer or official, or other person charged with similar public or quasi-public duties, other than payments required or permitted by the laws of the United States or any jurisdiction thereof.

  • Y2K Compliance PFPC further represents and warrants that any and all electronic data processing systems and programs that it uses or retains in connection with the provision of services hereunder on or before January 1, 1999 will be year 2000 compliant.

  • CRA Compliance Neither Buyer nor any Buyer Subsidiary has received any notice of non-compliance with the applicable provisions of the CRA and the regulations promulgated thereunder. As of the date hereof, Buyer’s and each Buyer Subsidiary’s most recent examination rating under the CRA was “satisfactory” or better. Buyer knows of no fact or circumstance or set of facts or circumstances which would be reasonably likely to cause Buyer or any Buyer Subsidiary to receive any notice of non-compliance with such provisions of the CRA or cause the CRA rating of Buyer or any Buyer Subsidiary to decrease below the “satisfactory” level.

  • ISRA Compliance (a) Tenant shall, at Tenant’s own expense, comply with the Industrial Site Recovery Act, N.J.

  • ADA Compliance If necessary, as of the Closing Date, Borrower shall be in compliance with the Americans with Disabilities Act of 1990 ("ADA"), or, if any renovations of Borrower's facilities or modifications of Borrower's employment practices shall be required to bring them into compliance with the ADA, review and approval by FINOVA of Borrower's proposed plan to come into such compliance. Borrower shall deliver representations and warranties to FINOVA concerning Borrower's compliance with the ADA, and no evidence shall have come to the attention of FINOVA indicating that Borrower is not in compliance with the ADA (except to the extent that FINOVA has reviewed and approved Borrower's plan to come into compliance).

  • Legal Compliance The Company, and the conduct and operations of its business, is in compliance with each applicable law (including rules and regulations thereunder) of any federal, state, local or foreign government, or any Governmental Entity, except for any violations or defaults that, individually or in the aggregate, have not had and would not reasonably be expected to have a Company Material Adverse Effect.

  • FINRA Compliance You represent and warrant that you are (a) a broker or dealer (as defined in Section 3(a)(4) or 3(a)(5) of the 0000 Xxx) that is a member in good standing of FINRA, (b) a non-U.S. bank, broker, dealer or other non-U.S. institution that is not eligible for membership in FINRA and is not required to be registered as a broker or dealer under the 1934 Act (a “non-member non-U.S. dealer”), or (c) only in the case of Offerings of Securities that are exempted securities (as defined in Section 3(a)(12) of the 1934 Act), and such other Securities as from time to time may be sold by a “bank” (as defined in Section 3(a)(6) of the 1934 Act (a “Bank”)), that you are a Bank that is acting in connection with the Offering in accordance with an applicable exception or exemption from the definitions of broker and dealer under Sections 3(a)(4) and 3(a)(5) of the 1934 Act. You further represent, warrant and agree that, in connection with any purchase or sale of the Securities wherein a selling concession, discount or other allowance is received or granted by or to you:

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

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