Manufacturing and Quality Audits Sample Clauses

Manufacturing and Quality Audits. ARIAD shall, and shall cause its Affiliates and Approved Manufacturers to, permit the FDA, the EMEA and other Regulatory Authorities to conduct such inspections of the ARIAD Manufacturing Facilities as the FDA, EMEA or such other Regulatory Authorities may request, and shall cooperate with such Regulatory Authorities with respect to such inspections and any related matters, in each case related to API and Clinical Product. ARIAD agrees to notify MERCK immediately (and, in any event within [***] ([***]) hours of becoming aware thereof) of any proposed or unannounced quality visit or quality inspections by any Regulatory Authority to an ARIAD Manufacturing Facility (whether owned by ARIAD, an Affiliate or a Approved Manufacturer) and if such inspection is reasonably related to (i) API or Clinical Product or (ii) equipment or systems used in the Manufacture of API or Clinical Product, agrees to keep MERCK fully informed about the results and conclusions of each such regulatory inspection, including actions taken by ARIAD, its Affiliates and Approved Manufacturers to remedy conditions cited in such inspections. If such visit or inspection is directly related to the API or Clinical Product or its Manufacture, ARIAD shall, and shall cause its Affiliates to (and shall use commercially reasonable efforts to cause its Approved Manufacturers to) permit one or more qualified representative(s) of MERCK to be present if requested by MERCK. ARIAD shall promptly, and in no event later than [***] ([***]) business days of receipt thereof, provide MERCK with copies of any written inspection reports issued by such Regulatory Authorities as well as any reports, documents or correspondence with respect to any Regulatory Authority requests or inspections of a ARIAD Manufacturing Facility if such reports, documents or correspondence are directly related to (i) API or Clinical Product or (ii) equipment or systems used in the Manufacture of API or Clinical Product, including, but not limited to, FDA Form 483, Notice of Observation, Establishment Inspection Report, and all correspondence relating thereto; provided that ARIAD may redact any information from such reports, documents or correspondence that is not reasonably related to API or Clinical Product or (ii) equipment or systems used in the Manufacture of API or Clinical Product. ARIAD, its Affiliates or the applicable Approved Manufacturer will be responsible for the development of responses that are required by any Regulatory...
Sample 1
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Manufacturing and Quality Audits. ARIAD shall permit the FDA, and other Regulatory Authorities to conduct inspections of the Manufacturing Facility as the FDA or such other Regulatory Authorities may request, and shall cooperate with such Regulatory Authorities with respect to such inspections and any related matters, in each case related to API. ARIAD agrees to give MEDINOL prior notice (when possible) of any such inspections, and to keep MEDINOL informed about the results and conclusions of each such regulatory inspection, including actions taken by ARIAD to remedy conditions cited in such inspections. ARIAD shall provide MEDINOL with copies of any written inspection reports issued by such Regulatory Authorities and all correspondence between ARIAD and the Regulatory Authorities related thereto, including, but not limited to, FDA Form 483, Notice of Observation, and all correspondence relating thereto, in each case relating to the API or general manufacturing concerns (i.e., Manufacturing Facility compliance or the like). MEDINOL shall have access, to all quality assurance and audits of ARIAD and to the buildings, records and areas of the Manufacturing Facility for the purposes of assessment of regulatory compliance. Additionally, upon notice by MEDINOL, ARIAD shall allow MEDINOL or MEDINOL’s designees, to conduct quality audits of the Manufacturing Facility and quality programs with respect to API no more frequently than once each calendar year; provided, that, MEDINOL may conduct more frequent audits in the event that specific quality issues arise as a result of manufacturing or testing.
Sample 1

Related to Manufacturing and Quality Audits

  • Manufacturing and Supply Genentech shall be responsible for manufacturing and supplying Licensed Products for clinical use and commercial sale in the Genentech Field.

  • Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

  • 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.

  • 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:

  • 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.

  • Manufacturing Agreement Each of the Sellers (as applicable) shall have executed and delivered to the Buyer the Manufacturing Agreement with respect to the portion of the Business conducted at the applicable Facility.

  • Research Analyst Independence The Company acknowledges that the Underwriters’ research analysts and research departments are required to be independent from their respective investment banking divisions and are subject to certain regulations and internal policies, and that such Underwriters’ research analysts may hold views and make statements or investment recommendations and/or publish research reports with respect to the Company and/or the offering that differ from the views of their respective investment banking divisions. The Company hereby waives and releases, to the fullest extent permitted by law, any claims that the Company may have against the Underwriters with respect to any conflict of interest that may arise from the fact that the views expressed by their independent research analysts and research departments may be different from or inconsistent with the views or advice communicated to the Company by such Underwriters’ investment banking divisions. The Company acknowledges that each of the Underwriters is a full service securities firm and as such from time to time, subject to applicable securities laws, may effect transactions for its own account or the account of its customers and hold long or short positions in debt or equity securities of the companies that may be the subject of the transactions contemplated by this Agreement.

  • 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.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • 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:

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