Final Regulatory Approval definition

Final Regulatory Approval means in relation to any Licensed Product, the approval by the regulatory authority in a given country as may be required before such Licensed Product may be sold in such country.
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Final Regulatory Approval means Regulatory Approval that allows for the immediate marketing and sale of a Licensed Product.
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Final Regulatory Approval means the Regulatory Approval granted by a Governmental Authority after the successful completion of a Phase III Clinical Trial.
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Examples of Final Regulatory Approval in a sentence

  • If Final Regulatory Approval is not obtained by May 1, 2018, or if, before that date, the applicable regulatory agency or a reviewing court rejects, modifies or imposes conditions on any of the Three Agreements, then, unless the Parties agree otherwise in writing, this Stipulation shall immediately terminate and the Parties shall not be bound by this Stipulation.

  • Regulatory Assets Pending Final Regulatory Approval June 30, December 31, Noncurrent Regulatory Assets If these costs are ultimately determined not to be recoverable, it could reduce future net income and cash flows and impact financial condition.

  • Regulatory Assets Pending Final Regulatory ApprovalMarch 31, December 31, 2017 2016 Noncurrent Regulatory Assets (in thousands) Regulatory Assets Currently Not Earning a ReturnStorm Related Costs $ 4,377 $ 4,377Other Regulatory Assets Pending Final Regulatory Approval 68 52 Total Regulatory Assets Pending Final Regulatory Approval $ 4,445 $ 4,429 If these costs are ultimately determined not to be recoverable, it could reduce future net income and cash flows and impact financial condition.

  • Within thirty (30) days of Final Regulatory Approval, the TAPS Carriers identified in Confidential Attachment C shall pay the Non- TAPS Parties identified in that attachment the amounts shown in order to defray litigation costs incurred and in consideration of litigation costs that will be avoided as a result of this Agreement.

  • Regulatory Assets Pending Final Regulatory ApprovalMarch 31, December 31, 2017 2016 Noncurrent Regulatory Assets (in millions) Regulatory Assets Currently Earning a ReturnStorm Related Costs $ 24.8 $ 25.1Regulatory Assets Currently Not Earning a ReturnRate Case Expenses 0.1 0.1 Total Regulatory Assets Pending Final Regulatory Approval $ 24.9 $ 25.2 If these costs are ultimately determined not to be recoverable, it could reduce future net income and cash flows and impact financial condition.

  • Within five (5) business days after Final Regulatory Approval, CPTAI and EMPCo shall dismiss with prejudice their appeal in the Settled Alaska Superior Court Case.

  • Upon Final Regulatory Approval, this Stipulation shall settle with prejudice all aspects of the challenges to the TAPS Carriers’ intrastate rates that are currently pending in the Settled RCA Dockets as well as the appeal pending before the Superior Court of the State of Alaska in Case No. 3AN-16-07498CI (the “Settled Alaska Superior Court Case”).

  • Upon Final Regulatory Approval, the challenges to the TAPS Carriers’ intrastate rates in the Settled RCA dockets shall be dismissed with prejudice and the dockets shall be terminated and closed.

  • Within thirty (30) days of Final Regulatory Approval, each of the Remaining Carriers shall file new permanent intrastate rates that are no higher than (a) $4.885 per barrel to Valdez, (b) $4.851 to Petro Star Valdez, and(c) $3.085 to GVEA, with such rates to take effect as permanent rates on the first day of the month that occurs at least thirty (30) days after the filing of the new rates.

  • The following discusses ratemaking developments in 2014 and updates TNC’s 2013 Annual Report.Regulatory Assets Pending Final Regulatory ApprovalSeptember 30, December 31, 2014 2013 Noncurrent Regulatory Assets (in thousands) Regulatory Assets Currently Not Earning a ReturnRate Case Expenses $ 3 $ 3 Total Regulatory Assets Pending Final Regulatory Approval $ 3 $ 3 If these costs are ultimately determined not to be recoverable, it could reduce future net income and cash flows and impact financial condition.


More Definitions of Final Regulatory Approval

Final Regulatory Approval means the approvals of this Agreement and the Renewable Resource procurement by the IPUC and OPUC pursuant to orders the terms of which are fully satisfactory to both Idaho Power and City of Boise.
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Final Regulatory Approval means all approvals and master files, establishment licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the promotion, manufacture, use, storage, transport or sale of a Collaboration Product in the Territory (including NDA Approvals and approvals of Product Labeling). CONFIDENTIAL TREATMENT HAS BEEN GRANTED FOR THE REDACTED PORTIONS OF THE AGREEMENT THAT ARE MARKED WITH ASTERISKS AND BRACKETS ([***]). A COMPLETE COPY OF THIS AGREEMENT, INCLUDING THE REDACTED PORTIONS, HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.
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Final Regulatory Approval means that a Consent Judgment Compliance Letter was issued by NJDEP pursuant to the 2011 Consent Judgment for the specified contaminants, media and areas of concern identified in the letter . The Consent Judgment Compliance Letter is the Department’s equivalent of a No Further Action letter that is issued after all appropriate remediation documents have been finalized with respect to the applicable contaminants, media and areas of concern, an RAR Determination has been made, and after the issuance by the Department of any required remedial action permits. The Notes to the Master Schedule, Attachment 2 to this Report defines the term “RAR Determination.”
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Related to Final Regulatory Approval

  • 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.

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • MAA Approval means approval by the EMEA of a marketing authorization application (“MAA”) filed with the EMEA for the applicable Licensed Product under the centralized European procedure. If the centralized EMEA filing procedure is not used, MAA Approval shall be achieved upon the first Approval for the applicable Licensed Product in any two of the following countries: France, Germany, Italy, Spain or the United Kingdom.

  • Regulatory Approvals with respect to the Warrantholder, means, to the extent applicable and required to permit the Warrantholder to exercise this Warrant for shares of Common Stock and to own such Common Stock without the Warrantholder being in violation of applicable law, rule or regulation, the receipt of any necessary approvals and authorizations of, filings and registrations with, notifications to, or expiration or termination of any applicable waiting period under, the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended, and the rules and regulations thereunder.

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

  • 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.

  • 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.

  • 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.