Review and Regulatory Submission Sample Clauses

Review and Regulatory Submission. Institution and Investigator acknowledge that the completed FDQ may be subject to review by governmental or regulatory authorities, Sponsor, and their agents and that the FDQ may be included in a regulatory submission in the USA and that the U.S. Food and Drug Administration (FDA) reserves the right to make the information public if it feels that this is in the public interest. Institution and Investigator shall ensure to obtain, from each investigator, prior written consent as necessary for such review and transfer.
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Review and Regulatory Submission. Institution and Investigator acknowledge that the completed FDQ may be subject to review by governmental or regulatory authorities, Sponsor, and their agents and that the FDQ may be included in a regulatory submission in the USA and that the U.S. Food and Drug Administration (FDA) reserves the right to make the information public if it feels that this is in the public interest. Investigator shall ensure to obtain, from each investigator, prior written consent as necessary for such review and transfer. 11.3 Kontrola a předkládání regulačním orgánům. Zdravotnické zařízení a Zkoušející berou na vědomí, že vyplněné FDQ mohou podléhat kontrole ze strany státních nebo regulačních orgánů, Zadavatele a jeho příslušných zástupců a mohou se stát součástí podání u regulačních orgánů v USA a že si Úřad USA pro kontrolu potravin a léčiv (U.S. Food and Drug Administration – FDA) vyhrazuje právo zveřejnit tyto informace, pokud se domnívá, že je to ve veřejném zájmu. Zkoušející zajistí, aby od každého zkoušejícího obdrželi předchozí písemný souhlas potřebný k takové kontrole a převodu.
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Related to Review and Regulatory Submission

  • Regulatory Filing In the event that this Interconnection Construction Service Agreement contains any terms that deviate materially from the form included in Attachment P or from the standard terms and conditions in this Appendix 2, the Transmission Provider shall file the executed Interconnection Construction Service Agreement on behalf of itself and the Interconnected Transmission Owner with FERC as a service schedule under the Tariff. Interconnection Customer may request that any information so provided be subject to the confidentiality provisions of Section 17 of this Appendix

  • Review and Approval Documents specified above must be submitted for review and approval by CITY Purchasing and Contracts prior to the commencement of work by CONTRACTOR. Neither approval by CITY nor failure to disapprove the insurance furnished by CONTRACTOR shall relieve CONTRACTOR of CONTRACTOR’S full responsibility to provide the insurance required by this Contract. Compliance with the insurance requirements of this Contract shall not limit the liability of CONTRACTOR or its sub-contractors, employees or agents to CITY or others, and shall be in addition to and not in lieu of any other remedy available to CITY under this Contract or otherwise. CITY reserves the right to request and review a copy of any required insurance policy or endorsement to assure compliance with these requirements.

  • REPORT SUBMISSION 1. Copies of reporting packages for audits conducted in accordance with 2 CFR Part 200, Subpart F-Audit Requirements, and required by PART I of this form shall be submitted, when required by 2 CFR 200.512, by or on behalf of the recipient directly to the Federal Audit Clearinghouse (FAC) as provided in 2 CFR 200.36 and 200.512

  • SUBMISSIONS You acknowledge and agree that any questions, comments, suggestions, ideas, feedback, or other information regarding the Site ("Submissions") provided by you to us are non-confidential and shall become our sole property. We shall own exclusive rights, including all intellectual property rights, and shall be entitled to the unrestricted use and dissemination of these Submissions for any lawful purpose, commercial or otherwise, without acknowledgment or compensation to you. You hereby waive all moral rights to any such Submissions, and you hereby warrant that any such Submissions are original with you or that you have the right to submit such Submissions. You agree there shall be no recourse against us for any alleged or actual infringement or misappropriation of any proprietary right in your Submissions.

  • Ongoing Review and Revisions As set forth in Section 35.7, the Parties have agreed to the coordination and exchange of data and information under this Agreement to enhance system reliability and efficient market operations as systems exist and are contemplated as of the Effective Date. The Parties expect that these systems and the technology applicable to these systems and to the collection and exchange of data will change from time to time throughout the term of this Agreement. The Parties agree that the objectives of this Agreement can be fulfilled efficiently and economically only if the Parties, from time to time, review and, as appropriate, revise the requirements stated herein in response to such changes, including deleting, adding, or revising requirements and protocols. Each Party will negotiate in good faith in response to such revisions the other Party may propose from time to time. Nothing in this Agreement, however, shall require any Party to reach agreement with respect to any such changes, or to purchase, install, or otherwise implement new equipment, software, or devices, or functions, except as required to perform this Agreement.

  • TIMELINESS OF BILLING SUBMISSION The parties agree that timeliness of billing is of the essence to this Contract and recognize that the City is on a fiscal year. All xxxxxxxx for dates of service prior to July 1 must be submitted to the City no later that the first Friday in August of the same year.

  • REGULATORY FILINGS AND CAISO TARIFF COMPLIANCE 3.1 Filing

  • Claims Submission We will submit your claims and assist you in any way we reasonably can to help get your claims paid. Your insurance company may need you to supply certain information directly. It is your responsibility to comply with their request. Please be aware that the balance of your claim is your responsibility whether or not your insurance company pays your claim. Your insurance benefit is a contract between you and your insurance company; we are not party to that contract.

  • Program Compliance The School Board shall be responsible for monitoring the program to provide technical assistance and to ensure program compliance.

  • Legal and Regulatory Compliance The Consultant shall perform all services and prepare documents in compliance with the applicable requirements of laws, codes, rules, regulations, ordinances, and standards.

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