Regulatory and Quality Assurance Sample Clauses

Regulatory and Quality Assurance. (a) Dynavax acknowledges that, except for its or any of its subcontractor's DMF's, Triangle shall be solely responsible for (i) filing all regulatory documents with the FDA and foreign regulatory agencies in connection with the Development Program and Registration of all Licensed Products and (ii) quality assurance oversight in respect of the Licensed Products. Dynavax will reasonably assist Triangle by providing such data as are available to Dynavax which are necessary for Triangle to fulfill all FDA and foreign regulatory reporting requirements in respect of the Finished Drug Substance supplied hereunder. Dynavax will use its best efforts to cause any subcontractor which it uses in connection with the manufacture of the Licensed Products to fully disclose all data relating to such subcontractor's manufacturing activities to Triangle.
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Regulatory and Quality Assurance. (a) Dynavax acknowledges that, except for any of its subcontractor's DMF's, Triangle shall be solely responsible for (i) filing all regulatory documents with the FDA and foreign regulatory agencies in connection with the Development Program and Registration of all Licensed Products and (ii) quality assurance oversight in respect of the Licensed Products. Dynavax will reasonably assist Triangle by providing with such data as area available to Dynavax which are necessary for Triangle to fulfill all FDA and foreign regulatory reporting requirements in respect of the Licensed Products supplied hereunder. Dynavax will use its best efforts to cause any subcontractor which it uses in connection with the manufacture of the Licensed Products to fully disclose all data relating to such subcontractor's manufacturing activities to Triangle.
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Regulatory and Quality Assurance 
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Related to Regulatory and Quality Assurance

  • Quality Assurance Licensee agrees that all use of the Licensed Subject Matter shall be only upon the Products manufactured by or for Licensee in accordance with quality standards approved by Licensor prior to the commencement of manufacturing of the Products. Licensee shall submit for Licensor's sole and absolute approval the type of cereal, the name of cereal, the packaging design, advertising material, and all other materials to be used in connection with the Products subject to the sole and absolute approval of Licensor which shall not be unreasonably delayed or withheld.

  • SEC Reporting and Compliance (a) Parent filed a registration statement on Form SB-2 under the Securities Act which became effective on February 1, 2002 and was not withdrawn, and a registration statement on Form 10-SB under the Exchange Act, which became effective on October 15, 2001. Since October 15, 2001 and except as set forth on Schedule 3.8, Parent has timely filed with the Commission all registration statements, proxy statements, information statements and reports required to be filed pursuant to the Exchange Act. Parent has not filed with the Commission a certificate on Form 15 pursuant to Rule 12h-3 of the Exchange Act.

  • Money Market Fund Compliance Testing and Reporting Services Subject to the authorization and direction of the Trust and, in each case where appropriate, the review and comment by the Trust’s independent accountants and legal counsel, and in accordance with procedures that may be established from time to time between the Trust and the Administrator, the Administrator will:

  • Scope of Cooperation 1) Party A authorizes Party B as the sole distribution agent of the “Case edition” and “Channel edition” of China Marketing and China Business and Trade in the territory of Hunan Province (not including post offices) and Party B is responsible for the distribution matter within such area. Party A will support Party B to achieve a good performance in the regional marketing and promotion and guarantee the legitimate rights and interests of Party B during the term of this agreement.

  • MARKETING AND REPRESENTATIONS 8.1 The Fund or its underwriter shall periodically furnish Insurance Company with the following documents, in quantities as Insurance Company may reasonably request:

  • Maintenance of Company Separateness The Company will, and will cause each of its Subsidiaries to, satisfy customary Business formalities, including (to the maximum extent required under applicable Business laws) the holding of regular board of directors’ and shareholders’ meetings or action by directors or shareholders without a meeting and the maintenance of Business records. Neither the Company nor any other Credit Party shall make any payment to a creditor of any Non-Guarantor Subsidiary in respect of any liability of any Non-Guarantor Subsidiary, and no lender account of any Non-Guarantor Subsidiary shall be commingled with any lender account of the Company or any other Credit Party. Any financial statements distributed to any creditors of any Non-Guarantor Subsidiary shall clearly establish or indicate the corporate separateness of such Non-Guarantor Subsidiary from the Company and its other Subsidiaries. Finally, neither the Company nor any of its Subsidiaries shall take any action, or conduct its affairs in a manner, which is likely to result in the Business existence of the Company, any other Credit Party or any Non-Guarantor Subsidiaries being ignored, or in the assets and liabilities of the Company or any other Credit Party being substantively consolidated with those of any other such Person or any Non-Guarantor Subsidiary in a bankruptcy, reorganization or other insolvency proceeding.

  • MARKETING MATERIALS AND REPRESENTATIONS (a) The Participant represents and warrants that it will not make any representations concerning a Fund, Creation Units or Shares, other than those consistent with the Prospectus or any Marketing Materials (as defined below) furnished to the Participant by the Distributor.

  • REGULATORY ADMINISTRATION SERVICES BNY Mellon shall provide the following regulatory administration services for each Fund and Series:  Assist the Fund in responding to SEC examination requests by providing requested documents in the possession of BNY Mellon that are on the SEC examination request list and by making employees responsible for providing services available to regulatory authorities having jurisdiction over the performance of such services as may be required or reasonably requested by such regulatory authorities;  Assist with and/or coordinate such other filings, notices and regulatory matters and other due diligence requests or requests for proposal on such terms and conditions as BNY Mellon and the applicable Fund on behalf of itself and its Series may mutually agree upon in writing from time to time; and

  • Certain Assurances (a) Owner shall duly execute, acknowledge and deliver, or shall cause to be executed, acknowledged and delivered, all such further agreements, instruments, certificates or documents, and shall do and cause to be done such further acts and things, in any case, as Mortgagee shall reasonably request for accomplishing the purposes of this Agreement and the other Operative Agreements, provided that any instrument or other document so executed by Owner will not expand any obligations or limit any rights of Owner in respect of the transactions contemplated by any Operative Agreement.

  • Fund Valuation and Financial Reporting Services (1) Account for Fund share purchases, sales, exchanges, transfers, dividend reinvestments, and other Fund share activity as reported by the Fund’s transfer agent on a timely basis.

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