Notification of Governmental Authority Visit, Inspection or Inquiry Sample Clauses

Notification of Governmental Authority Visit, Inspection or Inquiry. Vendor shall, to the extent permissible by Applicable Law, advise Keryx immediately (but in no event more than [***] hours after Vendor awareness of scheduled visits or inspections and no more than [***] hours after Vendor awareness of unscheduled visits or inspections) of any Regulatory Authority visit or inspection that relates to Product, raw materials, or the Manufacturing Facility, or any written or oral inquiries by such Regulatory Authority concerning Product (including safety and efficacy claims), raw materials, or any Manufacturing Facility. If such visit or inspection or inquiry is related to Product, raw materials, or the Manufacturing Facility, Vendor shall to the extent permissible by Applicable Law ensure that one representative of Keryx is allowed to be present on site, if requested by Keryx. Again to the extent permissible by Applicable Law, Vendor shall promptly (and in no event later than [***] of its own receipt) furnish Keryx available summaries of all reports, documents and correspondence with respect to any Regulatory Authority inquiries, visits or inspections of the Manufacturing Facility or otherwise related to Product or raw materials as well as, to the extent permissible by Applicable Law, a copy of each report, document and correspondence issued by or provided to any Regulatory Authority in connection with such request, visit or inquiry. To the extent permissible by Applicable Law, Vendor and Keryx shall consult with one another in an effort to arrive at a mutually acceptable response to the extent related to Product. Without limiting the foregoing, Vendor shall furnish to Keryx, to the extent permissible by Applicable Law, (a) within [***] after receipt, any report or correspondence issued by the Regulatory Authority in connection with such visit, inspection or inquiry, including if applicable any FDA Form 483, Establishment Inspection Report, or warning letter, and (b) copies of any and all proposed responses or explanations to any Authority relating to items set forth above prior to the submission of such responses or explanations to any Regulatory Authority by Vendor and will consult with, and require approval from, Keryx before responding to each such communication, provided that the documents specified in (a) and (b) of this Section 6.1.19 may be redacted to remove the confidential information of Vendor’s other customers. Vendor will provide Keryx with a copy of its final responses within [***] after submission.
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Related to Notification of Governmental Authority Visit, Inspection or Inquiry

  • Authorization of Governmental Authorities No action by (including any authorization, consent or approval), in respect of, or filing with, any governmental authority or regulatory body is required for, or in connection with, the valid and lawful authorization, execution, delivery and performance by it of this Agreement, subject to, in the case of the Debtors, the entry by the Bankruptcy Court of the Approval Order.

  • Obtaining of Governmental Approvals The Company will from time to time take all action which may be necessary to obtain and keep effective any and all permits, consents and approvals of governmental agencies and authorities and securities act filings under United States Federal and state laws (including without limitation a registration statement in respect of the Warrants and Warrant Securities under the Securities Act of 1933, as amended), which may be or become requisite in connection with the issuance, sale, transfer, and delivery of the Warrant Securities issued upon exercise of the Warrants, the issuance, sale, transfer and delivery of the Warrants or upon the expiration of the period during which the Warrants are exercisable.

  • Compliance; Governmental Authorizations The Seller has complied in all material respects with all applicable Federal, state, local or foreign laws, ordinances, regulations and orders. The Seller has all Federal, state, local and foreign governmental licenses and permits necessary in the conduct of the Subject Business the lack of which would have a material adverse effect on the Buyer's ability to operate the Subject Business after the Closing on substantially the same basis as presently operated, such licenses and permits are in full force and effect, no violations are or have been recorded in respect of any thereof and no proceeding is pending or threatened to revoke or limit any thereof. None of such licenses and permits shall be affected in any material respect by the transactions contemplated hereby.

  • Approvals of Governmental Bodies As promptly as practicable after the date of this Agreement, Buyer will, and will cause each of its Related Persons to, make all filings required by Legal Requirements to be made by them to consummate the Contemplated Transactions (including all filings under the HSR Act). Between the date of this Agreement and the Closing Date, Buyer will, and will cause each Related Person to, cooperate with Sellers with respect to all filings that Sellers are required by Legal Requirements to make in connection with the Contemplated Transactions, and (ii) cooperate with Sellers in obtaining all consents identified in Part 3.2 of the Disclosure Letter; provided that this Agreement will not require Buyer to dispose of or make any change in any portion of its business or to incur any other burden to obtain a Governmental Authorization.

  • Notification of Government Investigation or Legal Proceeding Provider shall notify OIG, in writing, of any ongoing investigation or legal proceeding by a governmental entity or its agents involving an allegation that Provider has committed a crime or has engaged in fraudulent activities, within 30 days of Provider receiving notice of such investigation or legal proceeding. This notification shall include a description of the allegation(s), the identity of the investigating or prosecuting agency, and the status of such investigation or legal proceeding. Within 30 days after resolution of the matter, Provider shall notify OIG, in writing, of the resolution of the investigation or legal proceeding.

  • Consents and Approvals of Governmental Authorities No consent, approval, or authorization of, or declaration, filing, or registration with, any governmental or regulatory authority is required to be made or obtained by the Seller in connection with the execution, delivery, and performance of this Agreement or any of the other Acquisition Documents by the Seller.

  • Notices from Governmental Authority promptly, and in any event within 30 days of receipt thereof, copies of any notice to the Company or any Subsidiary from any Federal or state Governmental Authority relating to any order, ruling, statute or other law or regulation that could reasonably be expected to have a Material Adverse Effect; and

  • Compliance with Legal Requirements; Governmental Authorizations (a) Other than with respect to laws concerning Taxes (which are addressed in Section 3.9), laws concerning employee benefits (which are addressed in Section 3.10), and Environmental Laws (which are addressed in Section 3.14): (i) each Longhorn Entity is, and at all times since January 1, 2010 has been, in compliance in all material respects with each Legal Requirement that is or was applicable to it; (ii) no event has occurred or circumstance exists (with or without notice or lapse of time) (A) that is reasonably likely to constitute or result in a material violation by any Longhorn Entity of, or a material failure on the part of any Longhorn Entity to comply with, any Legal Requirement applicable to it or (B) that is reasonably likely to give rise to any material obligation on the part of any Longhorn Entity; and (iii) no Longhorn Entity has received, at any time since January 1, 2010, any written or other notice or other communication from any Governmental Entity or any other Person regarding (A) any actual or alleged violation of, or failure to comply with, any Legal Requirement applicable it or (B) any actual or alleged material obligation on the part of any Longhorn Entity. (b) Except as set forth on Schedule 3.11(b), each Longhorn Entity possesses all material Permits, all such material Permits are in full force and effect, and each Longhorn Entity is and at all times since January 1, 2010 has been in compliance in all material respects with all material Permits. No Longhorn Entity has received any notice to the effect that, or otherwise been advised of (i) any actual or alleged material violation of, or failure to comply with, any material Permits or (ii) any actual or alleged revocation, withdrawal, suspension, cancellation or termination of, or any modification to, any material Permit or the commencement or threatened commencement of any proceeding to do any of the foregoing. To the Knowledge of Seller, no event has occurred or circumstance exists that (with or without notice or lapse of time) is reasonably likely to (i) constitute or result directly or indirectly in a material violation by any Longhorn Entity of, or a failure on the part of any Longhorn Entity to comply with, any material Permits or (ii) result directly or indirectly in the revocation, withdrawal, suspension, cancellation or termination of, or any modification to, any material Permit.

  • COMPLIANCE WITH GOVERNMENTAL RULES AND REGULATIONS; RECORDS The Trust assumes full responsibility for its compliance with all securities, tax, commodities and other laws, rules and regulations applicable to it.

  • Other Governmental Regulations To the extent that this Agreement may be funded by fiscal assistance from another governmental entity, Consultant and any subcontractors shall comply with all applicable rules and regulations to which City is bound by the terms of such fiscal assistance program.

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