Quality Control; Regulatory Compliance Clause Samples

Quality Control; Regulatory Compliance. Licensee agrees that the Licensed Product sold by it and the processes for manufacturing, storage and handling of such Licensed Product shall strictly comply with all Applicable Law (including cGMP) and Licensee’s manufacturing standards (such standards to be no less stringent than industry standards used by companies that manufacture similar products for sales in countries that are regulated by SRAs) relating to any operations involved in the manufacture, packaging, labeling, quality control, testing, receipt, storage of, warehousing, and shipping, of Licensed Product, including but not limited to regulations for protection of worker health and safety. Licensee shall immediately notify MPP in writing of any action (including any official notifications or communications) taken by any Agency in the Territory in connection with Licensee’s failure to meet the standards set forth in this Section 9.1 for the manufacture and handling of the Licensed Product (“Agency Action”), such notice to set forth in reasonable detail all such failures and observations made by such Agency. If at any time, during the term of this Agreement, MPP is made aware of any Agency Action other than by Licensee pursuant to the preceding sentence, MPP shall promptly provide Licensee with a notice of the same. Licensee shall within a period of thirty (30) days from becoming aware of an Agency Action provide MPP with a plan for remedying the same within a timeline to be mutually agreed by the Parties, such agreement by either Party not to be unreasonably withheld or delayed. If Licensee is unable to remedy the same within the mutually agreed timeline (or, in the absence of such a mutually agreed timeline, within a reasonable period of time not to exceed ninety (90) days), MPP may, after giving Licensee written notice, terminate this Agreement at its sole discretion and without prejudice to any other remedies that may be available to MPP; provided however, that in the event that Licensee has already received a prior notice of any such violation, then MPP shall have the right to terminate this Agreement immediately without any notice.
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Related to Quality Control; Regulatory Compliance

  • Regulatory Compliance Neither Borrower nor any of its Subsidiaries is an “investment company” or a company “controlled” by an “investment company” under the Investment Company Act of 1940, as amended. Neither Borrower nor any of its Subsidiaries is engaged as one of its important activities in extending credit for margin stock (under Regulations X, T and U of the Federal Reserve Board of Governors). Borrower and each of its Subsidiaries has complied in all material respects with the Federal Fair Labor Standards Act. Neither Borrower nor any of its Subsidiaries is a “holding company” or an “affiliate” of a “holding company” or a “subsidiary company” of a “holding company” as each term is defined and used in the Public Utility Holding Company Act of 2005. Neither Borrower nor any of its Subsidiaries has violated any laws, ordinances or rules, the violation of which could reasonably be expected to have a Material Adverse Change. Neither Borrower’s nor any of its Subsidiaries’ properties or assets has been used by Borrower or such Subsidiary or, to Borrower’s knowledge, by previous Persons, in disposing, producing, storing, treating, or transporting any hazardous substance other than in material compliance with applicable laws. Borrower and each of its Subsidiaries has obtained all consents, approvals and authorizations of, made all declarations or filings with, and given all notices to, all Governmental Authorities that are necessary to continue their respective businesses as currently conducted. None of Borrower, any of its Subsidiaries, or any of Borrower’s or its Subsidiaries’ Affiliates or any of their respective agents acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement is (i) in violation of any Anti-Terrorism Law, (ii) engaging in or conspiring to engage in any transaction that evades or avoids, or has the purpose of evading or avoiding or attempts to violate, any of the prohibitions set forth in any Anti-Terrorism Law, or (iii) is a Blocked Person. None of Borrower, any of its Subsidiaries, or to the knowledge of Borrower and any of their Affiliates or agents, acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement, (x) conducts any business or engages in making or receiving any contribution of funds, goods or services to or for the benefit of any Blocked Person, or (y) deals in, or otherwise engages in any transaction relating to, any property or interest in property blocked pursuant to Executive Order No. 13224, any similar executive order or other Anti-Terrorism Law.

  • Anti-Bribery Compliance The Parties hereby acknowledge the importance of combating and preventing bribery and to that end both Parties agree to comply fully with all applicable laws, regulations and sanctions relating to anti-bribery and anti-corruption.

  • FERPA Compliance In connection with all FERPA Records that Contractor may create, receive or maintain on behalf of University pursuant to the Underlying Agreement, Contractor is designated as a University Official with a legitimate educational interest in and with respect to such FERPA Records, only to the extent to which Contractor (a) is required to create, receive or maintain FERPA Records to carry out the Underlying Agreement, and (b) understands and agrees to all of the following terms and conditions without reservation: