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.
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.
Regulatory Application. 10 1.27 Sepracor Know-How........................................10 1.28
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.
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.
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.
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.
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.
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.