By Governmental Entities Sample Clauses

By Governmental Entities. (i) Upon the request of any governmental entity or any third party entity authorized by a governmental entity, such entity shall have access to observe and inspect the Nordion Site and procedures used for the storage of B1 Antibody for the Labeled Drug and the manufacture, testing, storage or shipment of Labeled Drug, including without limitation, manufacturing operations, and to audit such facilities for compliance with cGMP and/or other applicable regulatory standards. To the extent it has advance notice, Nordion shall give Corixa notice of any inspections or audits by a governmental entity (or a third party authorized by a governmental entity) of the above-mentioned facilities or procedures within at least twenty-four (24) hours prior to the commencement of said inspection or audit. In all events, Nordion shall provide Corixa with a verbal summary of such inspection or audit at the end of each day in which inspection activity occurs and a written report within five (5) business days of the inspection or audit. Such summary and report will be subject to the confidentiality requirements of Section 14. (ii) Nordion shall notify Corixa within five (5) business days of any written or oral inquiries, notifications with respect to inspection activity by any governmental entity (or any third party authorized by a governmental entity) on matters that could adversely affect, whether directly or indirectly, Nordion's ability to perform under this Agreement. Nordion shall provide a reasonable description to Corixa of any such governmental inquiries, notifications or inspections promptly (but in no event later than five (5) business days) after such visit or inquiry. Nordion shall furnish to Corixa within five (5) business days after receipt, a summary of any report or correspondence issued by the governmental entity (or a third party authorized by a governmental entity) in connection with such visit or inquiry, including without limitation, any FDA Form 483 (List of Inspectional Observations) or warning letter with respect to Labeled Drug. Nordion shall also furnish to Corixa not later than five (5) business days after the time it provides such to a governmental entity, summaries of any and all proposed responses or explanations relating to the items set forth above (each a "Proposed Response"), in each case purged only of trade secrets or other Nordion Confidential Information. After the filing of a response with the appropriate governmental entity, Nordion shall ...
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Related to By Governmental Entities

  • Governmental Entities 19.1 For those customers, which are government entities, provisions within this agreement will apply to the extent the agency is not legally barred from executing such provisions by State or Federal law.

  • 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.

  • Governmental Entity “Governmental Entity” shall mean any federal, state, local or foreign court, arbitral tribunal, administrative agency or commission or other governmental or regulatory authority or administrative agency.

  • Governmental Authorities From the date of this Agreement and until the End Date, the Company shall duly observe and conform in all material respects to all valid requirements of governmental authorities relating to the conduct of its business or to its properties or assets.

  • 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.

  • 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.

  • 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.

  • No Governmental Consents No governmental, administrative or other third party consents or approvals are required, necessary or appropriate on the part of Subscriber in connection with the transactions contemplated by this Agreement.

  • Actions Before Governmental Authorities There are no actions, suits or proceedings at law or in equity or by or before any governmental authority now pending or, to the knowledge of Borrower, threatened against or affecting Borrower or its property, that is reasonably expected to result in a Material Adverse Effect.

  • Governmental Authorities; Consents No action by, consent, approval, permit or authorization of, or designation, declaration or filing with, any Governmental Authority or notice, approval, consent waiver or authorization from any Governmental Authority is required on the part of Acquiror with respect to the execution or delivery and performance of this Agreement by Acquiror or any Transaction Agreement to which any of Acquiror is a party, as applicable, or the consummation of the Transactions or the transactions contemplated thereby, except for (a) applicable requirements of the HSR Act, (b) the filing with the SEC of (i) the Proxy Statement (and the expiration of the waiting period in Rule 14a-6(a) under the Exchange Act or, if the preliminary Proxy Statement is reviewed by the SEC, receipt of oral or written notification of the completion of the review by the SEC) and (ii) such reports under Section 13(a) or 15(d) of the Exchange Act as may be required in connection with this Agreement, the Transaction Agreements or the Transactions or the transactions contemplated thereby, (c) such filings with and approval of Nasdaq to permit the Acquiror Common Stock to be issued in connection with the Transactions and the other Transaction Agreements to be listed on the Nasdaq, (d) the Acquiror Stockholder Approval, or (e) any actions, consents, approvals, permits or authorizations, designations, declarations or filings, the absence of which would not, individually or in the aggregate, reasonably be expected to have an Acquiror Material Adverse Effect.

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