Regulatory Closure definition

Regulatory Closure means the approval and acceptance by the proper Governmental Authority or Governmental Authorities of certain cleanup, closure, 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 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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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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Examples of Regulatory Closure in a sentence

  • Purchaser will obtain and deliver to Seller in connection with the Closing the original of the Regulatory Closure Bond and will maintain the Regulatory Closure Bond, as potentially modified or adjusted in accordance with this Section 9.06, until released by Seller.

  • Except for the amounts payable by Seller at Closing pursuant to Section 2.04, all costs of the Regulatory Closure Bond and the Environmental Insurance Policy shall be payable by Purchaser.

  • Purchaser shall use the cash paid to Purchaser pursuant to Section 2.04(f) solely to fund Purchaser's obligations arising under this Agreement with respect to the Required Remediation Actions, Plant Shutdown and Decommissioning, and other actions necessary to achieve Regulatory Closure of the Purchased Assets, including any Environmental Compliance and Response Actions.

  • Seller and Purchaser agree that $13,600,000 is the mutually-agreed estimated cost to obtain Preliminary Regulatory Closure of the Site F landfill.

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

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

  • The First Regulatory Closure of the FisheryIn October 1975, New York Governor Hugh Carey appointed a special commission to study the public health implications of elevated concentrations of PCBs in the Hudson River and to make recommendations for action.

  • If, upon Preliminary Regulatory Closure of the Site F landfill, the aggregate costs actually incurred by Purchaser to obtain Preliminary Regulatory Closure of the Site F landfill is less than $13,600,000, Purchaser shall pay such difference to Seller within thirty (30) days of Seller’s written request for such amount, which amount may, at Seller’s election, be paid in whole or in part to Seller as a distribution from the Escrowed Amount in accordance with the terms of the Escrow Agreement.

  • General Findings Sites with DNAPL Contamination Have Reached Regulatory Closure – Seven of the eight sites have received closure letters (or the equivalent) from regulators.

  • These include: 1) The Process for Establishing Soil Cleanup Standards, 2) Requirements for Addressing the Vapor Intrusion Pathway, 3) Fees for Review of Cleanup Related Documents, and 4) Regulatory Closure of Contamination Cases.


More Definitions of Regulatory Closure

Regulatory Closure has the meaning set forth in Section 3.17(g).
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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 an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • 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, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • 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 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 Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • Regulatory Approval means, with respect to a Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization from a Regulatory Authority in a country or other jurisdiction that is necessary to market and sell such Product in such 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 Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to 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 set out in Schedule C hereto;

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Regulatory Filing means any approvals, licenses, registrations, submissions and authorizations, and applications therefor, including IND, NDA, BLA, drug dossier or drug master file filed, or Marketing Approval obtained, with respect to an Option Product, Licensed Product or Companion Diagnostic, as applicable, in the Field, including all amendments, supplements, annual reports and the like thereof or therefor filed with or otherwise provided to the applicable Regulatory Authority.

  • 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.

  • 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 BMS and that otherwise fit the foregoing definition.

  • Regulatory Authorities means the Commissions and the Exchange;

  • Regulatory Action means an administrative, regulatory, or judicial 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, injunction or consent decree, issued by the FDA or a federal or state court.

  • 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.