Foreign Regulatory Approvals definition

Foreign Regulatory Approvals means all necessary regulatory approvals, permits, certifications, consents, licenses, registrations, listings, certificates of origin, and any other requisite documents and authorizations for the operation of a Plasma collection facility and the sourcing, collection, manufacture, testing, marketing, use, sale, handling, storage or distribution of Plasma, pursuant to any laws, treaties, statues, regulations or other requirements applicable in the European Union or any member country of the European Union.
Sample 1Sample 2Sample 3
Foreign Regulatory Approvals means all regulatory and other governmental approvals, clearances, registrations or permits which may be required to sell, market or otherwise commercialize a Product in any jurisdiction outside of the United States.
Sample 1Sample 2Sample 3
Foreign Regulatory Approvals means the Foreign Investment Approvals and the consents or approvals required under Antitrust as listed on Section 6.1(a)(ii) of the Company Disclosure Letter.
Sample 1

Examples of Foreign Regulatory Approvals in a sentence

  • Any Required Foreign Regulatory Approvals shall have been obtained and the required 30-day waiting period set forth in Section 323 of the Companies Law shall have lapsed.

  • As of the date hereof, all documents and other information and materials provided (including via email) or otherwise made available to the Company and its representatives in response to the Company’s or its representatives’ requests with respect to the Company’s analysis of Foreign Regulatory Approvals are true and correct in all material respects.

  • In the event that a New Center is found by Buyer to be materially deficient in its compliance with the applicable procedures or Regulatory Approvals (including Foreign Regulatory Approvals), Seller shall have fifteen (15) days to provide, in writing, a corrective action plan acceptable to Buyer in Buyer’s reasonable discretion.

  • Parent shall, with the reasonable cooperation of the Company, be responsible for making any filing or notification required for the purposes of the Foreign Regulatory Approvals.

  • In witness whereof, the Corporation has caused this Agreement to be executed and its seal affixed hereto by its officers thereunto duly authorized; and the Employee has executed this Agreement, as of the day and year first above written.

  • As of the date hereof, all documents and other information and materials provided (including by email) or otherwise made available to Parent and its representatives in response to Parent’s or its representatives’ requests with respect to Parent’s analysis of Foreign Regulatory Approvals are true and correct in all material respects.

  • To the Knowledge of Parent, as of the date hereof, the execution, delivery and performance by Parent and Merger Sub of this Agreement and the consummation of the Transactions requires no Foreign Regulatory Approvals other than the Required Regulatory Approvals.

  • The New Centers shall be constructed and operated in a manner that is compliant with all Regulatory Approvals, including Foreign Regulatory Approvals and qualify for approval by the relevant regulatory authorities in the United State and the European Union.


More Definitions of Foreign Regulatory Approvals

Foreign Regulatory Approvals means either (i) Parent receives notice in writing from the Australian Treasurer or his or her delegate to the effect that there are no objections under the Foreign Acquisitions and Takeovers Axx 0000 (Cth) (FATA) to the Parent consummating the Transactions, either unconditionally or subject to conditions with which the Parent is willing to comply (in its absolute discretion) or (ii) the Australian Treasurer (and each of his or her delegates) is, by reason of lapse of time, no longer empowered to make an order under FATA in respect of the Transactions.
Sample 1

Related to Foreign 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.

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

  • foreign regulatory authority means a securities commission, exchange or other securities market regulatory authority in a designated foreign jurisdiction;

  • 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.

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

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

  • Product Approval(s) 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.

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

  • Regulatory Authorizations means all approvals, clearances, notifications, authorizations, orders, exemptions, registrations, certifications, licenses and permits granted by, submitted to or filed with any Regulatory Agencies, including all Product Authorizations.

  • 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.

  • Foreign Financial Regulatory Authority shall have the meaning given by Section 2(a)(50) of the 0000 Xxx.

  • 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.

  • 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.

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation, all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).

  • Gaming Approvals means all Permits and Approvals issued by any Gaming Authority or under Gaming Laws necessary for or relating to the conduct of gaming and related activities or the manufacture, distribution, service or sale of alcoholic beverages, the ownership or the operation, management and development of any gaming operations, and, in the case of the Company, including the ownership, operation, management and development of the business of the Company and its Subsidiaries, and, in the case of the Acquirors, including the ownership, operation, management and development of the business of the Acquirors and its Subsidiaries.

  • 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.

  • Regulatory Authorities means the Commissions and the Exchange;

  • 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.

  • 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.

  • 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.

  • Foreign Antitrust Laws means the applicable requirements of antitrust competition or other similar Laws, rules, regulations and judicial doctrines of jurisdictions other than the United States.

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

  • 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.

  • 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.