Regulatory Approval Condition definition

Regulatory Approval Condition means the Investors or any of their Affiliates is required to wait for the expiration of any waiting period under, file any notice, report or other submission with, or obtain any consent, registration, approval, permit or authorization from any Governmental Entity under any applicable Law in connection with such transaction, including under (a) any U.S. or non-U.S. competition, merger control, antitrust or similar law, (b) any law that may be applicable to the direct or indirect ownership of equity in the Company and its Subsidiaries or (c) any law related to the foregoing.
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Regulatory Approval Condition means: (a) the Purchaser having received the RBI Approval on or prior to the Long Stop Date; (b) the Company having received the approval from the SEBI waiving or relaxing the enforcement of the requirement set out in Rule 19(2)(b) of the SCRR on or prior to the Long Stop Date; and (c) the Company having received the final listing and trading approval for the Equity Shares from the Stock Exchanges on or prior to the Long Stop Date.
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Regulatory Approval Condition means the condition set out in paragraph (b) of Section 4 of the Offers to Purchase, "Conditions of the Offers".
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Examples of Regulatory Approval Condition in a sentence

  • The Offer is conditioned upon, among other things, satisfaction of the Minimum Condition, the Insurance Regulatory Approval Condition, the Purchaser Obtaining Financing Condition and the Purchaser Obtaining Control Condition.

  • The Offer is conditioned upon, among other things, the satisfaction of the Minimum Condition, the Regulatory Approval Condition, the Governmental Authority Condition, the Representations Condition, the Covenants Condition and the Material Adverse Effect Condition.

  • For the avoidance of doubt, nothing contained herein shall require the Purchaser to complete all filings necessary to pursue the Regulatory Approval Condition before any specific date (including before the end of 2020), so long as the Purchaser is acting reasonably in pursuit thereof and otherwise in compliance with the provisions of this Agreement.

  • The Purchased Shares may not be exchanged, unless (a) the Regulatory Approval Condition is and remains satisfied at the time of the Exchange and (b) the Purchased Shares are exchanged in accordance with this Article VI.

  • Cooperation with third States and international organisations was identified as an issue of particular relevance.

  • Topco and the Company shall have the right to review in advance and, to the extent practicable, and subject to any restrictions under Applicable Law, the Purchaser shall consult with Topco and the Company with respect to, any filing made with, or written materials submitted to, any Governmental Authority or any third party in connection with the Regulatory Approval Condition and the consummation of the Exchange and the Purchaser shall incorporate any comments of Topco and the Company thereon.

  • The Laidlaw Environmental Offer is conditioned upon, among other things, the Minimum Tender Condition, the Laidlaw Environmental Stockholder Approval Condition, the Wisconsin Statutory Condition, the Rights Plan Condition and the Regulatory Approval Condition (in each case as defined in the Amended Exchange Offer).

  • The Offer is conditioned upon, among other things, satisfaction of the Rights Redemption Condition, the Minimum Condition, the Business Combination Condition, the Control Share Acquisitions Condition, the Insurance Regulatory Approval Condition, and the Purchaser Obtaining Financing Condition.

  • The Bidder shall not have any obligation to, and shall not have any obligation to procure that any of its Affiliates, (i) take any action to procure the satisfaction of the Regulatory Approval Condition that is not conditioned on the settlement of the Offer or (ii) offer or accept any undertakings, restrictions or conditions in order to obtain any regulatory approval, if such undertakings, restrictions or conditions would permit the Offeror to terminate the Offer.

  • The Application Materials and the Affiliated Person Notification shall have been timely submitted to the DOH and the Regulatory Approval Condition shall have been satisfied.


More Definitions of Regulatory Approval Condition

Regulatory Approval Condition means the Investor Parties or any of their Affiliates is required to wait for the expiration of any waiting period under, file any notice, report or other submission with, or obtain any consent, registration, approval, permit or authorization from any governmental entity under any applicable law in connection with such transaction, including under
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Regulatory Approval Condition means, as of any date of determination, the receipt by the Purchaser of all Governmental Approvals (including, for the avoidance of doubt, Governmental Approvals of Governmental Authorities that regulate Topco or its Subsidiaries and including complying with or meeting any conditions set out in such Governmental Approvals or expiration of any waiting periods required thereunder) required to enable the Exchange to take place at the time of the Exchange, and for the Purchaser to acquire such number of Topco Ordinary Shares as is equal to the number of Topco Ordinary Shares which are to be received by the Purchaser at the time of the Exchange; provided, that such Governmental Approvals shall be in full force and effect at the time of the Exchange; provided, further, that such Governmental Approvals shall be obtained no later than the Exchange Cutoff Date.
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Regulatory Approval Condition means that any Holder or any of its Affiliates is required to wait for the expiration of any waiting period under, file any notice, report or other submission with, or
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Regulatory Approval Condition means each condition set out in clause 2.2
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Related to Regulatory Approval Condition

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

  • Regulatory Approval means any and all approvals, licenses, registrations or authorizations of any Regulatory Authority that are necessary for the marketing and sale of a product in a country or group of countries.

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

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

  • Regulatory Approvals with respect to the Warrantholder, means, to the extent applicable and required to permit the Warrantholder to exercise this Warrant for shares of Common Stock and to own such Common Stock without the Warrantholder being in violation of applicable law, rule or regulation, the receipt of any necessary approvals and authorizations of, filings and registrations with, notifications to, or expiration or termination of any applicable waiting period under, the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended, and the rules and regulations thereunder.

  • 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.

  • FDA Approval means with respect to the Product, a Regulatory Approval by the FDA for the commercial use of the Product in the United States.

  • 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.

  • 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;

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

  • 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 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).

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

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

  • Regulatory Conditions means the conditions set out in paragraphs 3.3 to 3.5 (inclusive) of Part A of Appendix I to the Announcement;

  • 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 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.

  • Phase II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.

  • 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.

  • Development approval means a document from a governmental entity which authorizes the commencement of a development.

  • Phase I Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • 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).

  • 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 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.

  • 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.