Regulatory Application Sample Clauses

The Regulatory Application clause outlines the obligations of the parties to comply with relevant laws, regulations, or governmental approvals necessary for the execution or performance of the agreement. In practice, this clause may require one or both parties to obtain permits, file applications with regulatory bodies, or ensure ongoing compliance with changing legal requirements. Its core function is to allocate responsibility for regulatory compliance, thereby reducing the risk of legal violations and ensuring that the agreement remains enforceable and operational within the applicable legal framework.
Regulatory Application. Regulatory Application" shall mean any application or request necessary for the development, manufacture, distribution, marketing, promotion, offer for sale, use, import, export or sale of Product, including but not limited to, any applications or requests for: (i) approval of Product, including any NDAs, and supplements and amendments thereto; (ii) pre- and post-approval marketing authorizations (including any applications for prerequisite manufacturing approval or authorization related thereto); (iii) labeling approval; (iv) technical, medical and scientific licenses; and (v) registrations or authorizations from any national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity necessary for the development, manufacture, distribution, marketing, promotion, offer for sale, use, import, export or sale of Product.
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Regulatory Application. Within thirty (30) days of the date of this Agreement, NASB Holding or Acquisition Sub will file applications with OTS to merge Acquisition Sub with and into CBES.
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Regulatory Application. 10 1.27 Sepracor Know-How........................................10 1.28
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Regulatory Application. If the Company believes that any Change in Law or Change in Tax would give rise to a claim by the Company pursuant to Section 16.2, prior to making any such claim the Company shall first make an application to ERA for a review of the Energy Charge and diligently pursue such application with ERA in accordance with any prescribed procedures therefor and otherwise in good faith.
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Regulatory Application. „Povolenie“ znamená buď (i) povolenie na uvedenie na trh (vrátane podmienečného povolenia na uvedenie na trh) udelené Európskou liekovou agentúrou a/alebo (ii) program prístupu pre pacientov pred registráciou (pre-licensed patient access program) („PLPA“) alebo iný druh regulačného povolenia od slovenských orgánov (napr. povolenie pre terapeutické použitie Produktu podľa § 46 ods. 4 a nasl. zákona č. 362/2011 Z. z. o liekoch a zdravotníckych pomôckach a o zmene a doplnení niektorých zákonov, v znení neskorších predpisov 1.1 “Authorization” means either (i) the marketing authorization (including conditional marketing authorization) granted by the European Medicines Agency and/or (ii) a pre-licensed patient access program (“PLPA”) or other kind of regulatory approval from Slovak authorities (e.g. approval for therapeutic use of the Product pursuant to Sec. 46 par. 4 et seq. of Act No. 362/2011 Coll. on Medicinal Products and Medical Devices and on Amending and Supplementing certain laws, as amended (the “Act on Medicinal Products”)) for use of the Product prior to („ Zákon o liekoch“) na použitie Produktu pred udelením povolenia na uvedenie na trh Európskou liekovou agentúrou, ktoré umožňuje použitie Produktu v Slovenskej republike a schválenie takéhoto PLPA od spoločnosti MSD. the grant of the marketing authorization by the European Medicines Agency, enabling the Product to be used in Slovakia and approval for such PLPA program from MSD.
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Regulatory Application. The term "Regulatory Application" means a formal application submitted to the appropriate Regulatory Authority under applicable law seeking approval to market a Licensed Product within a country or group of countries in the Territory.
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Regulatory Application. Buyer shall: (i) as soon as is practicable, file an application on Form Y-3 with the Board of Governors of the Federal Reserve Bank of Chicago or the Federal Reserve System (the "Federal Reserve") seeking the Federal Reserve's approval of the transactions contemplated by this Agreement; (ii) provide OKFC with a copy of such application in advance of filing; (iii) use reasonable efforts to respond as promptly as practicable to all inquiries received from the Federal Reserve for additional information; (iv) request confidential treatment for information which OKFC requests in writing be so treated (although such confidential treatment may be rejected by the Federal Reserve so that such information will be publicly available); and (v) keep OKFC informed of the status of the application.
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Regulatory Application. 17.5.1 Where it is agreed or determined pursuant to Clause 17.3 that either the Company or CEB is entitled to a Tariff adjustment, the Parties shall make an application to the Utility Regulatory Authority for a review of the Tariff and shall diligently pursue such application with the Utility Regulatory Authority in accordance with any prescribed procedures therefor and otherwise in good faith. 17.5.2 If the Utility Regulatory Authority awards an adjustment to the Tariff as a result of such application, the Parties agree that Schedule 4 (Calculation of Payments) shall be deemed amended on the date of such award to reflect the Tariff adjustments awarded by the Utility Regulatory Authority.
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Regulatory Application. Within thirty (30) days of the date hereof, the Purchaser shall file all necessary applications with any federal or state agency required by the purchase of the Preferred Shares by the Purchaser contemplated hereunder.
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Related to Regulatory Application

  • Regulatory Approval 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.

  • Regulatory Approvals (a) Each Party shall, and shall cause its ultimate parent entity (as such term is defined in the HSR Act) to, use reasonable best efforts to file or otherwise submit, as soon as practicable after the date of this Agreement, all applications, notices, reports, filings and other documents reasonably required to be filed by such Party or its ultimate parent entity with or otherwise submitted by such Party or its ultimate parent entity to any Governmental Body with respect to the Contemplated Transactions, and shall file no later than ten (10) Business Days thereafter the Notification and Report Forms required by the HSR Act. Each Party shall (i) promptly supply the other with any information which may be required in order to effectuate such filings, (ii) submit promptly any additional information which may be reasonably requested by any such Governmental Body, and (iii) coordinate with the other Party in making any such filings or information submissions pursuant to and in connection with the foregoing that may be necessary, proper, or advisable in order to consummate and make effective the Contemplated Transactions. (b) Without limiting the generality of anything contained in this Section 5.4, in connection with its efforts to obtain all requisite approvals and authorizations, and the expiration or termination of all applicable waiting periods for the Contemplated Transactions under any Antitrust Law, each Party hereto shall use its reasonable best efforts to (i) cooperate with the other with respect to any investigation or other inquiry; (ii) promptly provide to the other a copy of all communications received by such Party from, or given by such Party to, any Governmental Body, in each case regarding the Contemplated Transactions; and (iii) to the extent not prohibited under applicable Antitrust Law, permit the other to review in advance any communication given by it to any Governmental Body concerning the Contemplated Transactions, consider in good faith the views of the other in connection with any proposed written communications by such Party to any Governmental Body concerning the Contemplated Transactions, and consult with each other in advance of any meeting or telephone or video conference with, any Governmental Body, and give the other or its outside counsel the opportunity to attend and participate in such meetings and conferences unless prohibited by the applicable Governmental Body; provided, that materials required to be provided pursuant to this Section 5.4(b) may be restricted to outside counsel and redacted to (A) remove references concerning the valuation of either Party, (B) comply with contractual arrangements, and (C) preserve attorney-client privilege. Neither Party shall commit to or agree with any Governmental Body to stay, toll or extend any applicable waiting period under applicable Antitrust Law, or pull and refile under the HSR Act, without the prior written consent of the other. Parent and the Company shall each pay one-half of the filing fee under the HSR Act relating to the HSR filing required for the Merger; provided, however, that each Party shall bear its own legal fees. (c) Except as required by this Agreement, prior to Closing, neither the Company nor Parent shall, and shall cause its Affiliates not to, acquire or agree to acquire by merging or consolidating with, or by purchasing a substantial portion of the assets of or equity in, or by any other manner, any Person or portion thereof, or otherwise acquire or agree to acquire any assets, if the entering into of an agreement relating to or the consummation of such acquisition, merger or consolidation would reasonably be expected to (i) impose any delay in the obtaining of, or significantly increase the risk of not obtaining, any authorizations, consents, orders, declarations or approvals of any Governmental Body necessary to consummate the Contemplated Transactions or the expiration or termination of any applicable waiting period, or (ii) increase the risk of any Governmental Body entering an order prohibiting the consummation of the Contemplated Transactions.