Clinical Trial Permits; Certifications; Authorizations Sample Clauses

Clinical Trial Permits; Certifications; Authorizations. As of the Effective Date, it and its Permitted Third Parties have such INDs or other filings with all Regulatory Authorities as are required to conduct the Product Clinical Trials and perform any and all of their obligations in connection with the Product Clinical Trials supervised by it. All such INDs and other filings are (i) valid and in full force and effect and no default has occurred, (ii) validly registered and on file with applicable Regulatory Authorities, (iii) in compliance with all formal filing and maintenance requirements, and (iv) in good standing, valid and enforceable. Opthea and its Affiliates have filed all required notices and responses to notices, supplemental applications, reports (including all adverse event/experience reports) and other required information with the FDA and all other applicable Regulatory Authorities, and all such information is accurate and complete in all material respects. Except as has been made available to Investor, Opthea has not received any notice that the FDA, other Regulatory Authority, institutional review board or independent ethics committee, has initiated, or threatened to initiate, a Clinical Hold or any action to suspend, delay or terminate any IND or otherwise restrict the preclinical or clinical research of either Product.
Sample 1
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Clinical Trial Permits; Certifications; Authorizations. CymaBay hereby represents and warrants that, as of the Effective Date, CymaBay and its Permitted Third Parties have such INDs or other filings with all Regulatory Authorities as are required to conduct the Product Clinical Trials and perform any and all of their obligations in connection with the Product Clinical Trials supervised by it. All such INDs and other filings are valid and in full force and effect and no default has occurred. Except as disclosed to Abingworth prior to the date hereof in the Data Room, CymaBay has not received any notice that the FDA, other Regulatory Authority, institutional review board or independent ethics committee, has initiated, or threatened to initiate, any action to suspend or terminate any IND or otherwise restrict the preclinical or clinical research of any Product.
Sample 1
Clinical Trial Permits; Certifications; Authorizations. Alnylam further covenants that it and its Permitted Third Parties have, or will have at the required times, such INDs or other filings with all Regulatory Authorities as are required to conduct the Product Clinical Trials and perform any and all of their material obligations in connection with the Product Clinical Trials supervised by it. All such INDs and other filings are valid and in full force and effect. Alnylam has not received any notice that the FDA, other Regulatory Authority, institutional review board or independent ethics committee, has initiated, or threatened to initiate, any action to suspend or terminate any IND or otherwise restrict the preclinical or clinical research of any Product.
Sample 1
Clinical Trial Permits; Certifications; Authorizations. Reata further covenants that, as of the Effective Date, (a) it has, and that it has obligated any Permitted Third Parties to have, at the required times, such INDs or other filings with all Regulatory Authorities as are required to conduct the Product Trials, and (b) all INDs and other required filings for the conduct of the Product Trials in existence as of the Effective Date are valid and in full force and effect and, to its knowledge, no default has occurred with respect to any material obligations thereunder. As of the Effective Date, Reata has not received any notice that the FDA, other Regulatory Authority, institutional review board or independent ethics committee, has initiated, or threatened to initiate, any action to suspend or terminate any IND for any Product Trial or otherwise require the indefinite termination or suspension of any planned Clinical Trial for the Product.
Sample 1

Related to Clinical Trial Permits; Certifications; Authorizations

  • Permits, Authorizations, Etc Buyers shall have ----------------------------- obtained any and all material permits, authorizations, consents, waivers and approvals required for the lawful consummation of the Merger.

  • Governmental Authorizations; Private Authorizations; Governmental Filings The Borrower has obtained, maintained and kept in full force and effect all Governmental Authorizations and Private Authorizations which are necessary for it to properly carry out its business, except where the failure to do so could not reasonably be expected to have a Material Adverse Effect, and made all material Governmental Filings necessary for the execution and delivery by it of the Facility Documents to which it is a party, the Borrowings by the Borrower under this Agreement, the pledge of the Collateral by the Borrower under this Agreement and the performance by the Borrower of its obligations under this Agreement, the other Facility Documents, and no material Governmental Authorization, Private Authorization or Governmental Filing which has not been obtained or made, is required to be obtained or made by it in connection with the execution and delivery by it of any Facility Document to which it is a party, the Borrowings by the Borrower under this Agreement, the pledge of the Collateral by the Borrower under this Agreement or the performance of its obligations under this Agreement and the other Facility Documents to which it is a party.

  • Regulatory Filings and Approvals Copies of all necessary governmental and third party approvals, registrations, and filings in respect of the transactions contemplated by this Agreement;

  • PERMITS, LICENSES AND GOVERNMENTAL AUTHORIZATIONS All building or other permits, certificates of occupancy, concessions, grants, franchises, licenses, certificates of need and other governmental authorizations and approvals required for the conduct of the Business or the use of the Assets, or waivers thereof, have been duly obtained and are in full force and effect and are described on EXHIBIT 2.3. There are no proceedings pending or, to the knowledge of Company and Shareholders, threatened, which may result in the revocation, cancellation or suspension, or any adverse modification, of any such licenses or permits.

  • Governmental Permits, Etc The Company has all necessary franchises, licenses, certificates and other authorizations from any foreign, federal, state or local government or governmental agency, department or body that are currently necessary for the operation of the business of the Company as currently conducted, except where the failure to currently possess such franchises, licenses, certificates and other authorizations is not reasonably likely to have a Material Adverse Effect.

  • Authorization; Approvals The issuance of the Policy and the execution, delivery and performance of this Agreement and the Insurance Agreement have been duly authorized by all necessary corporate proceedings. No further approvals or filings of any kind, including, without limitation, any further approvals of or further filings with any governmental agency or other governmental authority, or any approval of the Insurer’s board of directors or stockholders, are necessary for the Policy, this Agreement and the Insurance Agreement to constitute the legal, valid and binding obligations of the Insurer.

  • Government Authorizations No Consent of, with or to any Governmental Authority is required to be obtained or made by or with respect to Buyer or any of its Affiliates in connection with the execution and delivery of this Agreement and the other Transaction Documents by Buyer or the consummation by Buyer of the transactions contemplated hereby and thereby, except for (a) required filings under the HSR Act, (b) as set forth on Section 5.4 of the Buyer Disclosure Schedule, and (c) Consents not required to be made or given until after Closing.

  • Governmental Authorizations and Consents Each Credit Party shall have obtained all Governmental Authorizations and all consents of other Persons, in each case that are necessary or advisable in connection with the transactions contemplated by the Credit Documents and each of the foregoing shall be in full force and effect and in form and substance reasonably satisfactory to Administrative Agent. All applicable waiting periods shall have expired without any action being taken or threatened by any competent authority which would restrain, prevent or otherwise impose adverse conditions on the transactions contemplated by the Credit Documents or the financing thereof and no action, request for stay, petition for review or rehearing, reconsideration, or appeal with respect to any of the foregoing shall be pending, and the time for any applicable agency to take action to set aside its consent on its own motion shall have expired.

  • Governmental Permits and Approvals (a) All approvals, authorizations, consents, permits and licenses from governmental and regulatory bodies required for the transactions contemplated by this Agreement and to permit the business currently carried on by the Corporation to continue to be carried on substantially in the same manner immediately following the Closing Date shall have been obtained and shall be in full force and effect, and Owner shall have been furnished with appropriate evidence, reasonably satisfactory to him, of the granting of such approvals, authorizations, consents, permits and licenses; and

  • Governmental Authorization; Third Party Consent No approval, consent, compliance, exemption, authorization, or other action by or notice to, or filing with, any governmental authority or any other person or entity in respect of any requirements of law or otherwise is necessary or required by the Company in connection with the execution, delivery or performance by the Company of this Agreement, except for such approval, consent, compliance, exemption, authorization, or other action which, if not obtained or made, would not reasonably be likely to prevent or materially delay the Company from performing its obligations under this Agreement in all material respects.

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