Regulatory Transfer definition

Regulatory Transfer means a Transfer by the Investor pursuant to a Permitted Sale to the extent necessary (i) to comply with applicable Law, effectively binding written or oral “administrative guidance” from a Governmental Authority in Japan having competent jurisdiction over the Investor or its business (“Administrative Guidance”) or an Order by a Governmental Authority with competent jurisdiction over the Investor or its business (“Governmental Order”), or (ii) following the Company informing the Investor of an acquisition or change pursuant to Items (1)(c) and (2) of Schedule 5.3 of the Disclosure Letter that would or would reasonably be expected to result in the Investor being in violation of applicable Law in Japan, for the Company to no longer be deemed to be an affiliate of the Investor under applicable Law in Japan, and in each case of clauses (i) and (ii), only for the minimum amount of Shares that would be necessary to comply with such Law, Administrative Guidance or Governmental Order or for the Company to no longer be deemed to be an affiliate of the Investor under applicable Law in Japan, as applicable; provided, that the Investor shall notify the Company in writing about any such requirement or affiliation issue promptly after the Investor becomes aware of such requirement or affiliation issue, and, if practicable based on the timing of the actions required for compliance or disaffiliation, prior to any Transfer of Shares pursuant to this Section 4.1(b), a Senior Executive (as hereinafter defined) of the Investor shall discuss with a
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Regulatory Transfer has the meaning set forth in Section 2.4.2.
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Regulatory Transfer is defined in Section 6.8(a).
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Examples of Regulatory Transfer in a sentence

  • Shares of Series D-1 Preferred Stock shall not be convertible into Common Stock pursuant to Section 4.1.1 in the hands of a Regulated Holder or its Transferees (unless such conversion is in connection with a Permitted Regulatory Transfer (as defined below) (such restriction, the “Regulatory Conversion Restriction”).

  • Shares of Series D-1 Preferred Stock and Series E-1 Preferred Stock shall not be convertible into Common Stock pursuant to this Section 4 or otherwise in the hands of a Regulated Holder or its BHCA Transferees, except in connection with a Permitted Regulatory Transfer (as defined below) (such restriction, the “Regulatory Conversion Restriction”).

  • After the Effective Date but prior to occurrence of Regulatory Transfer in a given country, Licensor shall (i) have the authority to make all decisions regarding recalls and field actions and responses thereto with respect to the Products in such countries, and (ii) be responsible for performing or having performed the necessary corrective actions and management activities in response to such recall or field corrective action, subject to Section 4.1(d) below.

  • From the Effective Date until Regulatory Transfer occurs in a given country, Licensee will send to Licensor by secure email within 24 hours of its receipt, a copy of any correspondence from that country’s Regulatory Authority specifically involving the Product, with the exception that any information not specifically involving the Product may be redacted at Licensee’s discretion.

  • Unless otherwise determined by Purchaser, the shares of Series C Preferred Stock shall, upon the consummation of a Permitted Regulatory Transfer, automatically convert into shares of Voting Common Stock in accordance with this Section 8 and Section 9.

  • If the Option Exercise Condition has been satisfied, the Buyer may exercise the Option at any time between the Regulatory Transfer Date and on or prior to the Option Exercise Outside Date.

  • Shares of Series B-1 Preferred Stock shall not be convertible into Common Stock pursuant to this Section 4 or otherwise in the hands of a Regulated Holder or its BHCA Transferees, except in connection with a Permitted Regulatory Transfer (as defined below) (such restriction, the “Regulatory Conversion Restriction”).

  • After the Effective Date but prior to occurrence of Regulatory Transfer in a given country, Licensor shall be responsible for, with respect to any such country, all of the regulatory reporting related to such Products, and shall incur the costs associated therewith, in accordance with the Transition Plan.

  • From the date of the applicable Regulatory Transfer in a given country and thereafter, Licensee shall be responsible for performing all complaint handling activities for the Products and bearing any costs related thereto.

  • Subject to Section 4.1(d) below with respect to Major Challenges, in the event of routine Product changes, Licensor shall be responsible for performing the necessary engineering and supply management activities until such time as US Regulatory Transfer occurs, and Licensee shall provide support related thereto, all in accordance with the Transition Plan.


More Definitions of Regulatory Transfer

Regulatory Transfer means, for the United States, the US Regulatory Transfer; for countries of the European Union, the EU Regulatory Transfer; and for the rest of the world, the OUS/OEU Regulatory Transfer. Unless otherwise specifically noted, references to the “Regulatory Transfer” herein are intended to cover any of the foregoing.
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Regulatory Transfer means the Transfer by a Majority Investor of Class A Units or other Equity Securities to the extent required to (i) bring such Majority Investor or its Affiliates into compliance (or into anticipated prospective compliance) with a Change in Law, provided that such requirement shall be supported by the advice of legal counsel or (ii) materially reduce or eliminate the impact on, or applicability to, the Majority Investor of any bank regulatory or other regulatory restrictions that might otherwise be imposed upon such Majority Investor or its Affiliates as a result of the Majority Investor’s or its Affiliates’ status as a bank holding company or a financial holding company under the BHC Act or the Xxxx-Xxxxx Act and would reasonably be expected to have a material and adverse impact on such Majority Investor or its Affiliates; provided that, in respect of this sub-clause (ii), such Majority Investor shall have attempted in good faith, using commercially reasonable efforts, to restructure its ownership interest in the Company prior to such Regulatory Transfer to address such bank regulatory or other regulatory restrictions such that it would not reasonably be expected to have a material and adverse impact on the Majority Investor or its Affiliates.
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Related to Regulatory Transfer

  • Regulatory entity means any board, commission, agency,

  • Regulatory Exclusivity means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to a pharmaceutical product other than Patents, including orphan drug exclusivity, new chemical entity exclusivity, data exclusivity, or pediatric exclusivity.

  • Regulatory Event means, following the occurrence of a Change in Law (as defined below) with respect to the Issuer and/or Société Générale as Guarantor or in any other capacity (including without limitation as hedging counterparty of the Issuer, market maker of the Certificates or direct or indirect shareholder or sponsor of the Issuer) or any of its affiliates involved in the issuer of the Certificates (hereafter the “Relevant Affiliates” and each of the Issuer, Société Générale and the Relevant Affiliates, a “Relevant Entity”) that, after the Certificates have been issued, (i) any Relevant Entity would incur a materially increased (as compared with circumstances existing prior to such event) amount of tax, duty, liability, penalty, expense, fee, cost or regulatory capital charge however defined or collateral requirements for performing its obligations under the Certificates or hedging the Issuer’s obligations under the Certificates, including, without limitation, due to clearing requirements of, or the absence of, clearing of the transactions entered into in connection with the issue of, or hedging the Issuer’s obligation under, the Certificates, (ii) it is or will become for any Relevant Entity impracticable, impossible (in each case, after using commercially reasonable efforts), unlawful, illegal or otherwise prohibited or contrary, in whole or in part, under any law, regulation, rule, judgement, order or directive of any governmental, administrative or judicial authority, or power, applicable to such Relevant Entity (a) to hold, acquire, issue, reissue, substitute, maintain, settle, or as the case may be, guarantee, the Certificates, (b) to acquire, hold, sponsor or dispose of any asset(s) (or any interest thereof) of any other transaction(s) such Relevant Entity may use in connection with the issue of the Certificates or to hedge the Issuer’s obligations under the Certificates,(c) to perform obligations in connection with, the Certificates or any contractual arrangement entered into between the Issuer and Société Générale or any Relevant Affiliate (including without limitation to hedge the Issuer’s obligations under the Certificates) or (d) to hold, acquire, maintain, increase, substitute or redeem all or a substantial part of its direct or indirect shareholding in the Issuer’s capital or the capital of any Relevant Affiliate or to directly or indirectly sponsor the Issuer or any Relevant Affiliate, or (iii) there is or may be a material adverse effect on a Relevant Entity in connection with the issue of the Certificates.

  • Regulatory Capital Treatment Event means the good faith determination by the Corporation that, as a result of (i) any amendment to, or change in, the laws or regulations of the United States or any political subdivision of or in the United States that is enacted or becomes effective after the initial issuance of any share of Series F Preferred Stock, (ii) any proposed change in those laws or regulations that is announced after the initial issuance of any share of Series F Preferred Stock, or (iii) any official administrative decision or judicial decision or administrative action or other official pronouncement interpreting or applying those laws or regulations that is announced after the initial issuance of any share of Series F Preferred Stock, there is more than an insubstantial risk that the Corporation will not be entitled to treat the full liquidation value of the shares of Series F Preferred Stock then outstanding as “tier 1 capital” (or its equivalent) for purposes of the capital adequacy guidelines of the Board of Governors of the Federal Reserve System, Regulation Y, 12 CFR 225 (or, as and if applicable, the capital adequacy guidelines or regulations of any successor Appropriate Federal Banking Agency), as then in effect and applicable, for as long as any share of Series F Preferred Stock is outstanding.

  • Regulatory asset means an asset recorded on the books of an

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

  • Regulatory Authority means any applicable supranational, national, regional, state or local regulatory agency, department, bureau, commission, counsel, or other government entity involved in granting of Regulatory Approval for a Licensed Product in a regulatory jurisdiction within the Territory, including the FDA and the EMEA.

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • 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.

  • Regulatory Submissions means any filing, application or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals and any pricing or reimbursement approvals, as applicable, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.

  • Requesting Authority means the Authority making a request under this MoU.

  • Regulatory assets means the unamortized net regulatory assets that are capitalized or deferred on the regulatory books of the electric utility, pursuant to an order or practice of the public utilities commission or pursuant to generally accepted accounting principles as a result of a prior commission rate-making decision, and that would otherwise have been charged to expense as incurred or would not have been capitalized or otherwise deferred for future regulatory consideration absent commission action. "Regulatory assets" includes, but is not limited to, all deferred demand-side management costs; all deferred percentage of income payment plan arrears; post-in-service capitalized charges and assets recognized in connection with statement of financial accounting standards no. 109 (receivables from customers for income taxes); future nuclear decommissioning costs and fuel disposal costs as those costs have been determined by the commission in the electric utility's most recent rate or accounting application proceeding addressing such costs; the undepreciated costs of safety and radiation control equipment on nuclear generating plants owned or leased by an electric utility; and fuel costs currently deferred pursuant to the terms of one or more settlement agreements approved by the commission.

  • 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 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.

  • securities regulatory authority or “SRA” means a body created by statute in any Canadian or foreign jurisdiction to administer securities law, regulation and policy (e.g. securities commission), but does not include an exchange or other self regulatory entity;

  • 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.

  • Regulatory Agreement means the regulatory agreement between HPD and the Owner establishing certain controls upon the operation of the Exemption Area during the term of the Exemption.

  • Regulatory Body means those government departments and regulatory, statutory and other entities, committees, ombudsmen and bodies which, whether under statute, rules, regulations, codes of practice or otherwise, are entitled to regulate or investigate the matters dealt with in this Agreement or any other affairs of the Provider or the Department, including, without limitation Ofsted, the European Commission and the European Court of Auditors;

  • Regulatory Documentation means, with respect to the Compounds, all submissions to Regulatory Authorities in connection with the development of such Compounds, including all INDs and amendments thereto, NDAs and amendments thereto, drug master files, correspondence with regulatory agencies, periodic safety update reports, adverse event files, complaint files, inspection reports and manufacturing records, in each case together with all supporting documents (including documents that include Clinical Data).

  • Applicable Insurance Regulatory Authority means the insurance department or similar insurance regulatory or administrative authority or agency of the jurisdiction in which the Company is domiciled.

  • 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).

  • Regulatory Law means the Xxxxxxx Act, as amended, the Xxxxxxx Act, as amended, the HSR Act, the Federal Trade Commission Act, as amended, and all other federal, state and foreign, if any, statutes, rules, regulations, orders, decrees, administrative and judicial doctrines and other laws that are designed or intended to prohibit, restrict or regulate actions having the purpose or effect of monopolization or restraint of trade or lessening of competition through merger or acquisition.

  • Regulatory Materials means materials developed or compiled in preparation for Regulatory Authority meetings, regulatory applications, submissions, dossiers, notifications, registrations, Regulatory Approvals and/or other filings made to or with, or other approvals granted by, a Regulatory Authority that are necessary or reasonably desirable for the Development, manufacture, market, sale, or Commercialization of a Licensed Product in a particular regulatory jurisdiction.