Written Communications to Governmental Authorities Sample Clauses

Written Communications to Governmental Authorities. In addition to all documents otherwise required to be provided to the other party by this Agreement, the applicable Study Agreement and applicable law, [***] agrees to promptly provide the [***] with a copy of all documents and other written or electronic communications related to any Clinical Study which it has submitted to any governmental authority including protocol amendments, information amendments, safety reports, annual reports, investigator reports, reports of unanticipated problems involving risks to subjects or others, reports of serious or continuing noncompliance with applicable laws and regulations or the requirements of an institutional review board/ethics committee (“IRB/EC”) or reports of the suspension or termination of IRB/EC approval of human subjects research related to a Clinical Study. Information provided will be deemed Confidential Information (as defined in Section 8.1) of the party providing it as long as it otherwise qualifies as Confidential Information.
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Written Communications to Governmental Authorities. In addition to all documents otherwise required to be provided to the other party by this AGREEMENT, the applicable RESEARCH PROGRAM, CLINICAL TRIAL and APPLICABLE LAWS, to the extent permitted by APPLICABLE LAWS each party agrees to promptly provide the other parties with a copy of all documents and other written or electronic communications related to any RESEARCH PROGRAM or CLINICAL TRIAL which such party has submitted to any governmental authority including protocol amendments, information amendments, safety reports, annual reports, investigator reports, reports of unanticipated problems involving risks to subjects or others, reports of serious or continuing noncompliance with APPLICABLE LAWS and regulations or the requirements of an Institutional Biosafety Committee (IBC), institutional review board/ethics committee (“IBC/IRB/EC”) or reports of the suspension or termination of IBC/IRB/EC approval of human subjects research related to a RESEARCH PROGRAM [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. or CLINICAL TRIAL. Information provided will be deemed CONFIDENTIAL INFORMATION (as defined in Section 15) of the party providing it as long as it otherwise qualifies as CONFIDENTIAL INFORMATION.
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Written Communications to Governmental Authorities. In addition to all documents otherwise required to be provided to the other party by this Agreement, the applicable Project Agreement and applicable law, [***] agrees to promptly provide the COG and [***] with a copy of all documents and other written or electronic communications related to any Collaboration Project which it has submitted to any governmental authority including protocol amendments, information amendments, safety reports, annual reports, investigator reports, reports of unanticipated problems involving risks to subjects or others, reports of serious or continuing noncompliance with applicable laws and regulations or the requirements of an institutional review board/ethics committee (“IRB/EC”) or reports of the suspension or termination of IRB/EC approval of human subjects research related to a Collaboration Project. Information provided will be deemed Confidential Information (as defined in Section 8.1) of the party providing it as long as it otherwise qualifies as Confidential Information.
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Written Communications to Governmental Authorities. In addition to all documents otherwise required to be provided to the other party by this Agreement, the applicable Project Agreement and applicable law, the RA Sponsor agrees to promptly provide the COG and the other party with a copy of all material documents and other written or electronic communications related to any RA or Collaboration Project which it has submitted to any governmental authority including protocol amendments, information amendments, safety reports, adverse event reports, annual reports, investigator reports, reports of unanticipated problems involving risks to subjects or others, reports of serious or continuing noncompliance with applicable laws and regulations or the requirements of an institutional review board/ethics committee (“IRB/EC”) or reports of the suspension or termination of IRB/EC approval of human subjects research related to a Collaboration Project. To the extent reasonably possible, the RA Party agrees to seek and give due consideration to comments from the other party with respect to any material communication to any governmental authority that is related to any RA or Collaboration Project. Information provided under this Section 7.2 will be deemed Confidential Information (as defined in Section 8.1) of the party providing it as long as it otherwise qualifies as Confidential Information.
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Related to Written Communications to Governmental Authorities

  • 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.

  • 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.

  • 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 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.

  • 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

  • Requisite Governmental Approvals No Consent of any Governmental Authority is required on the part of Parent, Merger Sub or any of their Affiliates (a) in connection with the execution and delivery of this Agreement by each of Parent and Merger Sub; (b) the performance by each of Parent and Merger Sub of their respective covenants and obligations pursuant to this Agreement; or (c) the consummation of the Transactions, except (i) the filing of the Certificate of Merger with the Secretary of State of the State of Delaware and such filings with Governmental Authorities to satisfy the applicable laws of states in which the Company Group is qualified to do business; (ii) such filings and approvals as may be required by any federal or state securities laws, including compliance with any applicable requirements of the Exchange Act; (iii) compliance with any applicable requirements of the HSR Act and any other applicable Antitrust Laws; and (iv) such other Consents the failure of which to obtain would not, individually or in the aggregate, prevent or materially delay the consummation of the Transactions or the ability of Parent and Merger Sub to fully perform their respective covenants and obligations pursuant to this Agreement.

  • 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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