Governmental and Regulatory Inspections Sample Clauses

Governmental and Regulatory Inspections. BMS shall notify the Company immediately by telephone and in writing of any inspections conducted by any Governmental Entity of the premises where the Product is being manufactured, to the extent such inspection relates to the manufacture of the Product, and shall provide to *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. the Company copies of all correspondence, reports, notices, findings and other material pertinent to such inspections and that specifically relate to the Product. BMS may redact portions that do not specifically relate to the Product.
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Governmental and Regulatory Inspections. WSP shall notify WC of any inspections by any governmental or regulatory authorities of the premises where the Product is being manufactured, to the extent such inspection relates to the manufacture of the Products, promptly after such inspection, and shall provide to WC copies of all correspondence, reports, notices, findings and other material pertinent to such inspections or otherwise relating to the production, use or sale of the Products (including all Form 483s), promptly after they are received or produced by or on behalf of WSP from or to the FDA or any other federal, state or foreign governmental or regulatory authority. All notices sent to WC pursuant to this Section shall be sent to the attention of the Senior Vice-President of Regulatory Affairs, Normx Xxxxxx.
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Governmental and Regulatory Inspections. BMSLC shall notify WC of any inspections by any governmental or regulatory authorities of the premises where the Product is being manufactured, to the extent such inspection relates to the manufacture of the Products, promptly after such inspection, and shall provide to WC copies of all correspondence, reports, notices, findings and other material pertinent to such inspections or otherwise relating to the production, use or sale of the Products (including all Form 483s), promptly after they are received or produced by or on behalf of BMSLC from or to the FDA or any other federal, state or foreign governmental or regulatory authority. All notices sent to WC pursuant to this Section shall be sent to the attention of the Senior Vice-President of Regulatory Affairs, Normx Xxxxxx.
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Governmental and Regulatory Inspections. Each Party will notify the other Party of any inspections by any Governmental Authorities of the premises where the Product is being manufactured, tested or stored, to the extent such inspection relates to the manufacture, storage or distribution of the Products, within five Business Days after such inspection, and will provide to the other Party copies of all Forms 483 or other similar notifications of observations relating to the production, testing, storage, use or sale of the Products, redacted as necessary with respect to any portions of the Form 483 not pertaining to the Products, within five Business Days after they are received by or on behalf of a Party from the FDA or any Governmental Authority. All notices sent to a Party pursuant to this Section 9.2 will be sent to such Party in accordance with the Quality Agreement.
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Governmental and Regulatory Inspections. Xxxx shall promptly notify Kos of any inspections by any Governmental Authorities of the premises where any Processing Activities are taking place, to the extent such inspection relates to the Processing Activities for the Licensed Products in the Territory, and shall provide Kos copies of all correspondence, reports, notices, findings and other material pertinent to such inspections (including all Form 483s) promptly after they are received or produced by or on behalf of Xxxx from or to the FDA or any other Governmental Authority.
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Governmental and Regulatory Inspections. NTP shall notify LMI of any inspections by a regulatory authority relating to the manufacturing, packaging and testing of Raw Materials supplied to LMI, within five (5) business days of the inspection. When Final Materials supplied to LMI are implicated in regulatory inspection findings, NTP will provide redacted copies of all correspondence, reports, notices, findings and any other material pertinent to such inspections or otherwise relating to the production, use, or sale of the LMI products.
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Governmental and Regulatory Inspections. BMS shall notify the Company of any inspections by any governmental or regulatory authorities of the premises where the Product is being manufactured, to the extent such inspection relates to the manufacture of the Products, promptly after such inspection, and shall provide to the Company copies of all correspondence, reports, notices, findings and other material pertinent to such inspections (including all Form 483s) promptly after they are received or produced by or on behalf of BMS from or to the FDA or any other federal, state or foreign governmental or regulatory authority. All notices sent to Galex Xxxdings PLC, 100 Xxxxxxxxxx Xxxxx, Xxxxxxxx, XX 00000 Xxxention: Vice President Regulatory Affairs.
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Governmental and Regulatory Inspections. Xxxx shall promptly notify Xxxxx of any inspections by any Governmental Authorities of the premises where any Processing Activities are taking place, to the extent such inspection relates to the Processing Activities for the Licensed Product, and shall provide Xxxxx copies of all correspondence, reports, notices, findings and other material pertinent to such inspections (including all Form 483s) promptly after they are received or produced by or on behalf of Xxxx from or to the FDA or any other Governmental Authority. All notices shall be sent to Xxxxxx Xxxxxxxx, Inc., 000 Xxxxxxxxxx Xxxxx, Xxxxxxxx, XX 00000 Attention: Vice President Regulatory Affairs.
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Related to Governmental and Regulatory Inspections

  • Regulatory Inspections Manufacturer will permit Rhythm or its agents to be present and participate in any visit or inspection by any Authority of the Facility (to the extent it relates in any way to any Product) or the Manufacturing Process. Manufacturer will give as much advance notice as reasonably possible to Rhythm of any such visit or inspection. Manufacturer will provide Rhythm with a copy of any report or other written communication * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. received from such Authority in connection with such visit or inspection, and any written communication received from any Authority relating to any Product, the Facility (if it relates to or affects the Development and/or Manufacture of Product) or the Manufacturing Process, within two (2) business days after receipt, and will consult with, and require approval from, Rhythm before responding to each such communication. Manufacturer will provide Rhythm with a copy of its final responses within five (5) business days after submission.

  • Regulatory Investigations It shall be the Administrator’s duty and responsibility, and not the Owner Trustee’s duty and responsibility, to cause the Trust to respond to, defend, participate in or otherwise act in connection with any regulatory, administrative, governmental, investigative or other proceeding or inquiry relating in any way to the Trust, its assets or the conduct of its business.

  • Governmental and Regulatory Approvals Other than the filing of the Articles of Merger provided for under Section 1.3, all consents, approvals and actions of, filings with and notices to any Governmental Entity required by the Company, Parent or any of their subsidiaries under applicable law or regulation to consummate the Merger and the transactions contemplated by this Agreement, the failure of which to be obtained or made would result in a material adverse effect on Parent’s ability to conduct the business of the Company in substantially the same manner as presently conducted, shall have been obtained or made (all such approvals and the expiration of all such waiting periods, the “Requisite Regulatory Approvals”).

  • Governmental and Regulatory Consents All material filings required to be made prior to the Closing with, and all material consents, approvals, permits and authorizations required to be obtained prior to the Closing from, Governmental Entities, in connection with the execution and delivery of this Agreement and the consummation of the transactions contemplated hereby by Holding Co and Public Company will have been made or obtained (as the case may be).

  • Legal and Regulatory Compliance The issuance of Shares shall be subject to compliance with all applicable requirements of federal, state or foreign law with respect to such securities. If at any time the Company determines, in its discretion, that the listing, registration or qualification of the Shares upon any securities exchange or under any state or federal law, or the consent or approval of any governmental regulatory authority is necessary as a condition to the issuance of Shares to Participant (or his or her estate), such issuance will not occur unless and until such listing, registration, qualification, consent or approval will have been effected or obtained free of any conditions not acceptable to the Company. If the Company determines that the issuance of any Shares will violate federal securities laws or other applicable laws or regulations or the requirements of any exchange or market system upon which the Shares are listed, the Company may defer issuance until the earliest date at which the Company reasonably anticipates that the issuance of Shares will no longer cause such violation. The Company will make all reasonable efforts to meet the requirements of any such state or federal law or securities exchange and to obtain any such consent or approval of any such governmental authority, but the inability of the Company to obtain from any regulatory body having jurisdiction the authority, if any, deemed by the Company’s legal counsel to be necessary to the lawful issuance of any Shares shall relieve the Company of any liability in respect of the failure to issue such Shares as to which such requisite authority shall not have been obtained. As a condition to the issuance of Shares, the Company may require Participant to satisfy any qualifications that may be necessary or appropriate, to evidence compliance with any applicable law or regulation and to make any representation or warranty with respect thereto as may be requested by the Company.

  • Governmental and Third Party Approvals The Credit Parties shall have received all material governmental, shareholder and third party consents and approvals necessary (or any other material consents as determined in the reasonable discretion of the Administrative Agent) in connection with the transactions contemplated by this Agreement and the other Loan Documents and the other transactions contemplated hereby and all applicable waiting periods shall have expired without any action being taken by any Person that could reasonably be expected to restrain, prevent or impose any material adverse conditions on any of the Credit Parties or such other transactions or that could seek or threaten any of the foregoing, and no law or regulation shall be applicable which in the reasonable judgment of the Administrative Agent could reasonably be expected to have such effect.

  • Governmental Reporting Nothing in this Agreement is intended to interfere with or discourage the Executive’s good faith disclosure related to a suspected violation of federal or state law or regulation to any governmental agency or entity or making other disclosures that are protected under the whistleblower provisions of federal or state law or regulation. The Executive cannot and will not be held criminally or civilly liable under any federal or state trade secret law for disclosing otherwise protected trade secrets and/or confidential or proprietary information so long as the disclosure is made in (1) confidence to a federal, state, or local government official, directly or indirectly, or to an attorney and solely for the purpose of reporting or investigating a suspected violation of law; or (2) a complaint or other document filed in a lawsuit or other proceeding, so long as such filing is made under seal. Company will not retaliate against the Executive in any way for a disclosure made pursuant to this Section. Further, in the event the Executive makes such a disclosure, and files a lawsuit against the Company alleging that the Company retaliated against the Executive because of the disclosure, the Executive may disclose the relevant trade secret or confidential information to the Executive’s attorney, and may use the same in the court proceeding only if (1) the Executive ensures that any court filing that includes the trade secret or confidential information at issue is made under seal; and (2) the Executive does not otherwise disclose the trade secret or confidential information except as required by court order.

  • Regulatory Information Promptly, from time to time, copies of such reports and written information to and from any Governmental Authority, including the FCC and any PUC, with jurisdiction over the Property or business of any Company, as the Administrative Agent may reasonably request; and

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials conducted by the Company, and to the knowledge of the Company, the preclinical tests and clinical trials conducted on behalf of or sponsored by the Company, that are described in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures and all applicable laws and regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Prospectuses or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such Permits as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) for the operation of the Company’s business as currently conducted, except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement, the Time of Sale Prospectus or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

  • Governmental and Third Party Authorizations The execution and delivery by the Purchaser of the Transaction Documents to which the Purchaser is party, the performance by the Purchaser of its obligations hereunder and thereunder and the consummation of any of the transactions contemplated hereunder and thereunder do not require any consent, approval, license, order, authorization or declaration from, notice to, action or registration by or filing with any Governmental Authority or any other Person, except as described in Section 3.5.

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