Final Regulatory Approval definition

Final Regulatory Approval means, with respect to the United States or a jurisdiction within the Territory, receipt of all authorizations by the FDA or the appropriate Territorial Regulator or Regulators, as the case may be, necessary for commercial sale of the Product within such jurisdiction, including, without limitation, approval of manufacturing, labeling, price (if required) and treatment parameters.
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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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Examples of Final Regulatory Approval in a sentence

  • With an aim to promote all renewable energy grid-parity projects participating in green power trading, China will steadily promote the participation of green power projects enjoying national renewable energy subsidies in green power trading.

  • 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.

  • Subject to Section 3.4 herein, Endo shall commercialize the LidoPAIN(R) BP Product in the United States within six (6) months from the date on which LidoPAIN(R) BP Product receives Final Regulatory Approval in the United States so long as EpiCept shall have supplied Endo with quantities of the LidoPAIN(R) BP Product sufficient to commercially launch the Product as set forth in Endo's committed forecast delivered pursuant to the Supply Agreement.

  • With respect to those countries outside the United States in which EpiCept has obtained Final Regulatory Approval of the LidoPAIN(R) BP Product.

  • Within [* *] following NDA Approval for the Lead Product [* *], GSK will notify POZEN in writing of [* *], GSK will use Commercially Reasonable Efforts to initiate Commercial Launch of the Lead Product in the Territory as soon as commercially practicable after Final Regulatory Approval is granted, [* *] (excluding delays not within GSK’s control, if any, related to manufacturing issues or the requirements of the FDA), in accordance with the Product Launch Plan and Commercialization Plan.

  • Let us now take a look at the mode of creation and dissemination of the Methodological Recommendations.

  • Regulatory Assets Pending Final Regulatory Approval June 30, December 31, 2016 2015 Noncurrent Regulatory Assets (in thousands) Regulatory Assets Currently Earning a ReturnStorm Related Costs $ 24,532 $ 24,156Regulatory Assets Currently Not Earning a Return Rate Case Expenses 145 145 Total Regulatory Assets Pending Final Regulatory Approval $ 24,677 $ 24,301 If these costs are ultimately determined not to be recoverable, it could reduce future net income and cash flows and impact financial condition.

  • The approved costs of obtaining Final Regulatory Approval in the Non-U.S. Territory shall be included in budgets for Research and Development and Clinical Trials Costs for the Non-U.S. Territory and shall be reimbursed to Fresenius AG out of Non-U.S. Cash Flow in accordance with the terms of this Agreement.

  • This lack of awareness has been reinforced in many places by historically subsidized low electricity rates, which materially reduce the efficiency payoffs that may be realized by facility owners, and result in unacceptably long paybacks and low internal rates of return (IRR) on any such investments, including for up-front investments of capital.

  • The provisions of this Section I-6(d) shall remain in full force and effect even if Final Regulatory Approval of the Three Agreements is not obtained.


More Definitions of Final Regulatory Approval

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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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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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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Related to Final Regulatory Approval

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

  • 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.

  • 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;

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale of a Product as a pharmaceutical product in a regulatory jurisdiction.

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

  • FDA Approval means the approval, license, clearance or authorization of the FDA necessary for the marketing and sale of a product for human use in the United States.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

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

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

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • Pricing Approval means such governmental approval, agreement, determination or decision establishing prices for a Licensed Product that can be charged and/or reimbursed in regulatory jurisdictions where the applicable Governmental Authorities approve or determine the price and/or reimbursement of pharmaceutical products.

  • Regulatory Approvals means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

  • Product Approval means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).

  • FDA means the United States Food and Drug Administration and 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 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 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.

  • 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.

  • 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.

  • 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).

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • 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).

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • 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.