Applicable Regulatory Approvals definition

Applicable Regulatory Approvals means the Held Regulatory Approvals, the Withdrawn/Rejected Regulatory Approvals and the Regulatory Approvals Under Review. For clarity, Applicable Regulatory Approvals does not include the Retained Regulatory Approval.
Sample 1Sample 2
Applicable Regulatory Approvals means the requisite approvals of (i) the Prophecy Shareholders, if required, (ii) the Ursa Shareholders, (iii) the Court, (iv) the Exchange and
Sample 1
Applicable Regulatory Approvals means all approvals, consents and authorizations of all Governmental Entities and other regulators (including stock exchanges) reasonably necessary or desirable in connection with the Arrangement and the other transactions contemplated hereby;
Sample 1

Examples of Applicable Regulatory Approvals in a sentence

  • No Licence contains any burdensome term, provision, condition or limitation which has or could have a Material Adverse Effect on Normabec or the Business, and except the Applicable Regulatory Approvals, requires the consent, approval, permit or acknowledgement of any Person in connection with the completion of the transactions herein contemplated.

  • No Licence contains any term, provision, condition or limitation which has or could have a Material Adverse Effect on Prophecy, and except the Applicable Regulatory Approvals, requires the consent, approval, permit or acknowledgement of any Person in connection with the completion of the transactions herein contemplated.

  • Cook will cooperate reasonably with ACS to adjust packaging and make xxxxr changes necessary to sell the replaced Product in countries other than the country for which the replaced Product was originally intended, subject to Applicable Regulatory Approvals in such country and subject to agreement between Cook and ACS as to reimbursement of Cook's out-of-pocket costs.

  • The Plan is the product of an arms-length, good faith negotiation between Debtor, certain bondholders, the bond trustees, and SCDOT.c. Section 1129(a)(6) is Satisfied as the Applicable Regulatory Approvals Have Been Obtained.

  • Except as disclosed in Schedule “F”, no Licence contains any term, provision, condition or limitation which has or could have a Material Adverse Effect on Northern, and except the Applicable Regulatory Approvals, requires the consent, approval, permit or acknowledgement of any Person in connection with the completion of the transactions herein contemplated.

  • Parent and the Company each have filed, or as promptly as practicable hereafter, shall prepare and file, any applicable filings, including the filing necessary to obtain the Applicable Regulatory Approvals, required under Applicable Corporate Laws, the Investment Canada Act (Canada), the Competition Act (Canada), Applicable Securities Laws or any other applicable law relating to the Acquisition, the Information Circular and the transactions contemplated hereby.


More Definitions of Applicable Regulatory Approvals

Applicable Regulatory Approvals means the Authorizations of Governmental Entities or self-regulatory organizations set forth in Schedule 1.1 hereto.
Sample 1

Related to Applicable Regulatory Approvals

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

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

  • 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;

  • 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.

  • 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.

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

  • Product Approvals means any approvals, registrations, permits, licenses, consents, authorizations, and other approvals, and pending applications and requests therefor, required by applicable Agencies related to the research, Development, manufacture, distribution, finishing, packaging, marketing, sale, storage or transport of a Product within the United States of America, and includes, without limitation, all approvals, registrations, licenses or authorizations granted in connection with any Application related to that Product.

  • 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.

  • Required Governmental Approvals means the Company Required Governmental Approvals and the Parent Required Governmental Approvals.

  • Marketing Authorization means all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport, marketing and sale of Licensed Products in a country or regulatory jurisdiction.

  • 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.

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

  • Regulatory Authorizations means all approvals, clearances, authorizations, registrations, certifications, licenses and permits granted by any Regulatory Authority, including all INDs and NDAs.

  • Regulatory Laws means all Applicable Laws governing (i) the import, export, testing, investigation, manufacture, marketing or sale of the Product, (ii) establishing recordkeeping or reporting obligations, (iii) any Field Action or (iv) similar regulatory matters.

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

  • 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.

  • 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.

  • Gaming Approvals means with respect to any action by a particular Person, any consent, finding of suitability, license, approval or other authorization required for such action by such Person from a Gaming Authority or under Gaming Laws.

  • Regulatory Authorities means the Commissions and the Exchange;

  • Export Approvals has the meaning specified in Section 4.26(a).

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

  • 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.

  • Government Approvals means all permits, licenses, authorisations, consents, clearances, decrees, waivers, privileges, approvals from and filing with government instrumentalities necessary for the development, construction and operation of the Work.

  • Development Approvals means all permits and other entitlements for use subject to approval or issuance by CITY in connection with development of the Property including, but not limited to: (a) general plan, general plan amendments, specific plans and specific plan amendments; (b) tentative and final subdivision and parcel maps; (c) conditional use permits and master plans; (d) zoning, zoning map amendments, and zoning text amendments; and, (e) grading and building permits.

  • Project Approvals means all approvals, consents, waivers, orders, agreements, authorizations, permits and licenses required under Applicable Laws or under the terms of any restriction, covenant, easement or agreement affecting all or any applicable Phase of the Project, or otherwise necessary or desirable for the ownership, acquisition, construction, development, equipping, use or operation of the Project.

  • Insurance Regulatory Authority means, with respect to any Insurance Subsidiary, the insurance department or similar Governmental Authority charged with regulating insurance companies or insurance holding companies, in its jurisdiction of domicile and, to the extent that it has regulatory authority over such Insurance Subsidiary, in each other jurisdiction in which such Insurance Subsidiary conducts business or is licensed to conduct business.