Regulatory Acceptance definition

Regulatory Acceptance means the acceptance of the transaction contemplated hereby and the approval for listing of the Shares by the TSX Venture, AMEX and NZSX;
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Regulatory Acceptance means the acceptance of the transaction contemplated hereby and the approval for listing of the Shares comprised in the Securities by the Exchange;
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Regulatory Acceptance means the acceptance of the transaction contemplated hereby and the approval for listing of the Shares and the Warrant Shares by the Exchange;(u)
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Examples of Regulatory Acceptance in a sentence

  • Recent Advances in Development and Application of Physiologically-Based Pharmacokinetic (PBPK) Models: a Transition from Academic Curiosity to Regulatory Acceptance.

  • The Issuer also reserves the right to affix to the Securities the legend contained in this §8.2 or a similar legend if such legend is required to be affixed in order to secure Regulatory Acceptance or compliance with the U.S. Securities Act.

  • Additional approvals, such as building permits, are required for construction.CHAPTER 2 What if an Easement is Required?It is often necessary for a transit provider to acquire an easement from a landowner in order to locate a transit stop.

  • This abstract describes work undertaken in the context of the DynoTRAIN project, Railway Vehicle Dynamics and Track Interactions: Total Regulatory Acceptance for the Interoperable Network (www.triotrain.eu).

  • Validation and Regulatory Acceptance of Toxicological Test Methods.

  • In Vitro Tests and Regulatory Acceptance Validation of in vitro assays is necessary to demonstrate the relevance, reliability and predictability of new methodology, before gaining acceptance and usage as replacement for traditional in vivo methods (Balls and Karcher 1995).

  • Report of the Stockholm Conference on Validation and Regulatory Acceptance of New and Updated Methods in Hazard Assessment.

  • Validation and Regulatory Acceptance of Toxicological Test Methods: A Report of the ad hoc Interagency Coordinating Committee on the Validation of Alternative Methods.

  • Delivery against payment for the Units will be completed by the Issuer at its offices on the Closing Date being a date following Regulatory Acceptance at which time certificates representing the Shares and Warrants will be delivered to the Investor as the Investor shall instruct.

  • EPA will prepare a Background Review Document (BRD) addressing all critical areas outlined in Validation and Regulatory Acceptance of Toxicological Test Methods (Ref.


More Definitions of Regulatory Acceptance

Regulatory Acceptance means the acceptance of filing by the FDA or EMA, as applicable, of an application for Marketing Authorization, based on a threshold determination that such application is sufficiently complete to permit a substantive review, as described in 21 CFR 314.101(a) and 21 CFR 601.2(a) and equivalent regulations in any regulatory jurisdiction in the European Market, each as amended.
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Related to Regulatory Acceptance

  • 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.

  • 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.

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

  • Commercial Launch means the initial First Commercial Sale of a Product in the Territory.

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

  • Commercial Product means any such product as defined in FAR 2.101.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • First Indication means the first disease condition for which a particular Licensed Product has been approved by a Regulatory Authority.

  • Approved Product means any water fitting, plumbing product, material or component which is the subject of an existing WRAS Approval;

  • 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.

  • Direction-indicator lamp means the lamp used to indicate to other road-users that the driver intends to change direction to the right or to the left;

  • Commercial use request means a re- quest from or on behalf of one who seeks information for a use or purpose that furthers the commercial, trade, or profit interests of the requester or the person on whose behalf the request is made.

  • Project Application means the federal Section 5311 operating assistance project application submitted by the Municipal Corporation to, and as approved by the Commissioner for the Project described in Appendix C of this Agreement, including all project supporting information submitted therewith;

  • Replacement Product means electric generating capacity, capacity-related benefits, environmental attributes, Energy or other electric products from a generation resource other than the Facility that are provided or delivered to replace or substitute for Contract Capacity or Storage Capacity (or any Capacity-Related Benefit, Environmental Attribute, Other Electric Product, Contract Energy, or Storage Energy associated therewith), in each case, in whole or in part, pursuant to Section 4.6.

  • 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).

  • 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.

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

  • Renewal Application means a document used to collect pertinent data for renewal of permits

  • 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.

  • ANDA means Abbreviated New Drug Application.

  • Regulatory Body means those government departments and regulatory, statutory and other entities, committees, ombudsmen and bodies which, whether under statute, rules, regulations, codes of practice or otherwise, are entitled to regulate or investigate the matters dealt with in this Agreement or any other affairs of the Provider or the Department, including, without limitation Ofsted, the European Commission and the European Court of Auditors;

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

  • 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.

  • 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;