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

  • Delivery against payment for the Shares 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 will be delivered to the Investor as the Investor shall instruct.

  • 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.

  • Delivery against payment for the Shares and Warrants 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 will be delivered to the Investor as the Investor shall instruct.

  • Once the Subscription Agreement is accepted by the Corporation, the completion of the sale of Shares contemplated by this Subscription Agreement is subject only to Regulatory Acceptance being obtained.

  • Regulatory Acceptance Both parties agree to seek regulatory acceptance, to the extent required to do so.


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, with respect to the Licensed Product in any country or jurisdiction, all approvals (including, where required, pricing and reimbursement approvals), registrations, licenses or authorizations from the relevant regulatory authority in a country or jurisdiction that is specific to the Licensed Product and necessary to market and sell such Licensed Product in such country or jurisdiction.

  • FDA Approval means the approval of the United States Food and Drug Administration necessary for the marketing, distribution in interstate commerce and sale of the Initial Product (as defined in the Collaboration and License Agreement) in the United States.

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

  • Commercial Launch means the first commercial sale in the Territory of the Product by Par, its Affiliate or a permitted sublicensee, as the case may be, to a Third Party.

  • 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.

  • Project Application means the federal Section 5311 capital assistance project application submitted by the County 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).

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Licensed Product as a drug 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 an abbreviated new drug application filed with the FDA, pursuant to its rules and regulations (or any equivalent or replacement mechanism).

  • 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.