Regulatory Closure definition

Regulatory Closure means the approval and acceptance by the proper Governmental Authority or Governmental Authorities of certain cleanup or remediation work at or offsite of a Property in connection with a Release, as evidenced by written letter or similar formal communication affirming such approval and acceptance, including but not limited to “case closure” or “no further action” letters or communications of similar import and finality; provided, however, that any requirements for additional work set forth in any such communication as a condition of such approval and acceptance shall first have been first satisfied in full and confirmed in writing by the applicable Governmental Authority evidencing such satisfaction before Regulatory Closure is deemed to occur.
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Regulatory Closure has the meaning set forth in Section 3.17(g).
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Regulatory Closure means written confirmation from the EPA, the TCEQ, and each other environmental regulatory agency having jurisdiction over the Real Property, as applicable under Environmental Laws, that (i) all Required Remediation Actions have been performed and completed in compliance with all applicable Environmental Laws or other applicable governmental regulations and no further action is required for the Required Remediation Actions, and (ii) Plant Shutdown and Decommissioning and all other Response Actions or Environmental Compliance required pursuant to applicable Environmental Law have been performed and completed in compliance with all applicable Environmental Laws or other applicable governmental regulations and no further action is required for the Purchased Assets.
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Examples of Regulatory Closure in a sentence

  • Dense Non-Aqueous Phase Liquid Remediation: Selected Projects Approaching Regulatory Closure.

  • Regulatory Closure of Project (for research projects only, does not apply to QI projects)a.

  • Non-radiation workers are those individuals who do not work with radiation as part of their normal job duties at KSU.

  • Transition of the Site will be final after all Physical Completion activities are completed and Regulatory Closure is achieved.

  • Regulatory Closure will occur on a later date following completion and approval of all regulatory documentation.

  • All remaining actions will be identified in the RFPCA and will be finalized in accordance with that agreement.• Documentation identifying historical uses, characterization, and the completed remedial actions will be included in the RI/FS and CAD/ROD prior to Regulatory Closure.

  • Details of the remedial actions taken on Lot 3 are described in the “Data Package Report for Regulatory Closure - Lot No. 3,” by CEC and “TECHNICAL MEMORANDUM - Updated Soil Risk Evaluation, Lots 1 through 4,” produced by Evren Northwest (ENW) submitted to DEQ in December of 2008.

  • Regulatory Closure of Former Remediated Gasoline Service StationA gasoline service station was formerly operated on APNs 090-133-011 and 090-133-019 at the northwest corner of the intersection of North Lake Boulevard and Fox Street.

  • The Industry-Wide Course Fee Insurance Scheme (IWC) protects the students against the loss of paid course fees arising from the following events:1) Insolvency of the school 2) Regulatory Closure of the school 3) Direction issued by the Council for Private Education (CPE) For more information on Protection of Course Fees, please refer to CPE’s website: https://www.cpe.gov.sg/for-peis/protection-of-course-fees.

  • SPP Refining agrees to cooperate with MPC to place any land and groundwater use restrictions on the Park Penta Site to effectuate such Park Penta Regulatory Closure.


More Definitions of Regulatory Closure

Regulatory Closure based upon the applicable Real Property’s current use as an industrial facility, and (ii) ensure that the completed remedy will not materially and adversely affect the value or operation of the applicable Real Property in respect of its current uses.
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Related to Regulatory Closure

  • Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.

  • Regulatory Floodway means the channel of a river or other watercourse and the adjacent land areas that must be reserved in order to discharge the base flood without cumulatively increasing the water surface elevation more than a designated height.

  • Monitoring Indicator means a measure of HSP performance that may be monitored against provincial results or provincial targets, but for which no Performance Target is set;

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Regulatory Conditions means the conditions set out in paragraphs 3.3 to 3.5 (inclusive) of Part A of Appendix I to the Announcement;

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Regulatory Submissions means any filing, application or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals and any pricing or reimbursement approvals, as applicable, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Regulatory Approval means any and all approvals (including MAA Approval, and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits, notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a Product in any country or jurisdiction.

  • Regulatory Requirement means any law, regulation or court order, or any rule, direction, guideline, code, notice or restriction (whether or not having the force of law) issued by any regulatory authority, governmental agency (including tax authority), clearing or settlement bank or exchange, or industry or self-regulatory body, whether in or outside Hong Kong, to which HKICL, we or any other Participant or the respective affiliates or group companies, or you are subject or are expected to comply with from time to time.

  • Regulatory entity means any board, commission, agency,

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities as set out in Schedule C hereto;

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

  • Regulatory Authorities means the Commissions and the Exchange;

  • Regulatory Action means an administrative or regulatory enforcement action, proceeding, investigation or inspection, FDA Form 483 notice of inspectional observation, warning letter, untitled letter, other notice of violation letter, recall, seizure, Section 305 notice or other similar written communication, or consent decree, issued by the FDA.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Foreign Financial Regulatory Authority shall have the meaning given by Section 2(a)(50) of the 0000 Xxx.