Governmental Authority Inspections Sample Clauses

Governmental Authority Inspections. Each Party shall promptly notify the other Party of any proposed visit or inspection by any governmental authority relating to markets in the Territory where the Product has been commercialized or is being developed or commercialized, of a relevant manufacturing line for a Product for the purpose of evaluating compliance with quality and manufacturing standards, or equivalent regulatory regimes. Each * CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION. Party shall immediately notify the other Party of any unannounced visits or inspections as described above as soon as reasonably practical. The Party subject to inspection shall provide a brief daily summary during the inspection and a final summary report of the results of the inspection to the other Party in English. The Party subject to inspection shall promptly (and in no event later than ten (10) business days from its receipt of the subject reports, documents, or correspondence) furnish the other Party English summaries of all reports, documents, and correspondence with the governmental authority, with respect to any governmental authority requests or inspections of such facilities, in each case, to the extent relevant to the manufacture or distribution of the Product. For the avoidance of doubt, nothing in this Agreement shall require either Party to share documents subject to such Party’s attorney-client privilege unless the Parties have entered into a mutually acceptable agreement that will protect such privilege.
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Governmental Authority Inspections. Each Party agrees to notify the other Party within three (3) Business Days of any audit, inspection or communication by, or contact with, the FDA or other Governmental Authority which involves the Dental Products. Each Party agrees to provide the other Party with a copy of the portion of the audit or inspection report or contact document and any response provided, which relate to the Dental Products. Each Party will provide reasonable assistance to the other Party, at no charge, if necessary or appropriate to respond to audits, inspections, inquiries, or requests concerning any Dental Product by a Governmental Authority.
Governmental Authority Inspections. Each applicable Governmental Authority shall have duly inspected and approved the Improvements and issued the appropriate permit, license or certificate to evidence such approval.
Governmental Authority Inspections. During the Term, each Party will be responsible for handling and responding to any Governmental Authority inspections with respect to the Party’s role in the Development, manufacture and supply and Commercialization of the Licensed Products. Each Party will provide to the other Party any information reasonably requested by the other Party and all significant information requested by any Governmental Authority concerning any governmental inspection related to the Licensed Products, and will allow Governmental Authorities to conduct reasonable inspections upon the request of such Governmental Authority. In the event such Governmental Authorities conduct an inspection, the Party under inspection will inform the other Party of the occurrence of such inspection, and invite the other Party to participate in the inspection process.
Governmental Authority Inspections. Governmental Authorities shall have the right to inspect the Work, provided that the Governmental Authority has jurisdiction over the Work and as required by Law.

Related to Governmental Authority Inspections

  • 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.

  • Governmental Authorizations, Etc No consent, approval or authorization of, or registration, filing or declaration with, any Governmental Authority is required in connection with the execution, delivery or performance by the Company of this Agreement or the Notes.

  • Governmental Authorities and Consents Buyer is not required to submit any notice, report or other filing with any governmental authority in connection with the execution or delivery by it of this Agreement or the consummation of the Transaction and no consent, approval or authorization of any governmental or regulatory authority is required to be obtained by Buyer in connection with the execution and delivery of this Agreement or the consummation of the Transaction.

  • 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.

  • 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.

  • Governmental Authorizations Any registration, declaration or filing with, or consent, approval, license, permit or other authorization or order by, or exemption or other action of, any governmental, administrative or regulatory authority, domestic or foreign, that was or is required in connection with the valid execution, delivery, acceptance and performance by such Member under this Agreement or consummation by such Member (or any of its Affiliates) of any transaction contemplated hereby has been completed, made or obtained on or before the date hereof.

  • Governmental Authorization; Third Party Consents No approval, consent, compliance, exemption or authorization of any governmental authority or agency, or of any other person or entity, is necessary or required in connection with the execution, delivery or performance by, or enforcement against, the Warrant Holder of this Warrant Agreement or the transactions contemplated hereby.

  • Approvals of Governmental Authorities The Governmental Approvals listed in Schedule 11.01(b) shall have been received (or any waiting period shall have expired or shall have been terminated) and shall be in full force and effect.

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