Governmental and Regulatory Inspections Sample Clauses

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. 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. 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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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. 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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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 TCI and TLIC agree to cooperate fully in any insurance or judicial regulatory investigation or proceeding arising in connection with Contracts distributed under this Agreement. TCI and TLIC further agree to cooperate fully in any securities regulatory inspection, inquiry, investigation or proceeding or any judicial proceeding with respect to TLIC, TCI, their affiliates and their representatives to the extent that such inspection, inquiry, investigation or proceeding or judicial proceeding is in connection with Contracts distributed under this Agreement. Without limiting the foregoing: (a) TCI will be notified promptly of any customer complaint or notice of any regulatory inspection, inquiry investigation or proceeding or judicial proceeding received by TLIC with respect to TCI or any representative or which may affect TLIC’s issuance of any Contracts marketed under this Agreement; and (b) TCI will promptly notify TLIC of any customer complaint or notice of any regulatory inspection, inquiry, investigation or judicial proceeding received by TCI or any representative with respect to TLIC or its affiliates in connection with any Contracts distributed under this Agreement. In the case of a customer complaint, TCI and TLIC will cooperate in investigating such complaint and shall arrive at a mutually satisfactory response.

  • Governmental and Regulatory Approvals Approvals from any Governmental or Regulatory Authority (if any) necessary for consummation of the transactions contemplated hereby shall have been obtained.

  • 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 ‌ 4.22.1 During the term of this Contract, Contractor must comply with all local, state, and federal licensing, accreditation and registration requirements/standards, necessary for the performance of this Contract and all other applicable federal, state and local laws, rules, and regulations. 4.22.2 While on the HCA premises, Contractor must comply with HCA operations and process standards and policies (e.g., ethics, Internet / email usage, data, network and building security, harassment, as applicable). HCA will make an electronic copy of all such policies available to Contractor. 4.22.3 Failure to comply with any provisions of this section may result in Contract termination.

  • 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.

  • Regulatory Information (a) All the notaries at De Pinna LLP are regulated through the Faculty Office of the Archbishop of Canterbury. Its address is The Faculty Office, 0 Xxx Xxxxxxxxx, Xxxxxxxxxxx, Xxxxxx XX0X 0XX, its telephone: 000 0000 0000, and it can be reached by email at xxxxxxx.xxxxxx@0xxxxxxxxxxxx.xxx. It also has a website at xxx.xxxxxxxxxxxxx.xxx.xx. (b) We are required to comply with the rules of professional conduct and other regulatory arrangements of the Master of the Faculties, the sole regulator of notarial activities under the Legal Services Act 2007. Information about those rules and regulations may be found at xxxx://xxx.xxxxxxxxxxxxx.xxx.xx/notary/i-am-a-notary/notaries-rules-regulations/. (c) We comply with the Code of Practice published by the Master of the Faculties: xxxx://xxx.xxxxxxxxxxxxx.xxx.xx/notary/code-of-practice.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement 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; 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 or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals 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”); 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 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, regulations and policies of the Regulatory Agencies.

  • Legal and Regulatory Actions Contractor represents and warrants that it is not aware of and has received no notice of any court or governmental agency proceeding, investigation, or other action pending or threatened against Contractor or any of the individuals or entities included in numbered paragraph 1 of these Contract Affirmations within the five (5) calendar years immediately preceding execution of this Contract or the submission of any related Solicitation Response that would or could impair Contractor’s performance under this Contract, relate to the contracted or similar goods or services, or otherwise be relevant to System Agency’s consideration of entering into this Contract. If Contractor is unable to make the preceding representation and warranty, then Contractor instead represents and warrants that it has provided to System Agency a complete, detailed disclosure of any such court or governmental agency proceeding, investigation, or other action that would or could impair Contractor’s performance under this Contract, relate to the contracted or similar goods or services, or otherwise be relevant to System Agency’s consideration of entering into this Contract. In addition, Contractor acknowledges this is a continuing disclosure requirement. Contractor represents and warrants that Contractor shall notify System Agency in writing within five (5) business days of any changes to the representations or warranties in this clause and understands that failure to so timely update System Agency shall constitute breach of contract and may result in immediate contract termination.

  • Governmental Compliance The Tenant Improvements shall comply in all respects with the following: (i) the Code and other state, federal, city or quasi-governmental laws, codes, ordinances and regulations, as each may apply according to the rulings of the controlling public official, agent or other person; (ii) applicable standards of the American Insurance Association (formerly, the National Board of Fire Underwriters) and the National Electrical Code; and (iii) building material manufacturer’s specifications.

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