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 is defined in Section 6.8(a).
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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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Examples of Regulatory Transfer in a sentence

  • As of the close of business on the date of conversion, shares of Non-Voting Common Stock converted in accordance with this Section 4.6 shall not be deemed to be outstanding for any purpose and holders of converted Non-Voting Common Stock shall have no rights with respect to the Non-Voting Common Stock so converted, other than the right for the transferee in the Permitted Regulatory Transfer to receive the shares of Voting Common Stock issuable upon conversion of such Non-Voting Common Stock.

  • Effective immediately upon any Permitted Regulatory Transfer (as defined below), each share of Non-Voting Common Stock so transferred shall automatically be converted into one share of Voting Common Stock.

  • For clarity, if the Regulatory Transfer Date does not occur prior to the expiration of the Option Term for such Program, Section 2.6.1(a) (and not this Section 2.6.1(b)) shall apply.

  • Buyer shall notify the Seller at least twenty (20) Business Days prior to any Restricted Transfer or Regulatory Transfer, and at least five (5) Business Days prior to an Unrestricted Transfer.

  • For clarity, (a) during the Regulatory Transfer Period, NOVARTIS shall not be permitted to cancel or withdraw the IMD IND, and (b) NOVARTIS will file on a timely basis any annual report for the IMD IND due during the Regulatory Transfer Period.

  • 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”).

  • 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.

  • After the Regulatory Transfer in any country, Licensee will keep records of all Regulatory Reports and Requests as mandated by Applicable Law, and will provide Licensor with a monthly report summarizing trend analysis and results but only until the date upon which Licensor’s labeled Products are no longer being offered for sale by Licensor or its agents or distributors anywhere in the world.

  • Prior to the Regulatory Transfer Date, TBIL shall be responsible for, and, after the Regulatory Transfer Date, Takeda shall be responsible for, responding to medical questions or inquiries from members of the medical and paramedical professions and consumers regarding the Product in the Field in the Territory.

  • Appendix VII contains a complete and accurate list of the Contractual Transfer Restrictions and Regulatory Transfer Restrictions applicable to the transactions contemplated hereby that the parties have identified as of the date of this Agreement using commercially reasonable efforts.


More Definitions of Regulatory Transfer

Regulatory Transfer has the meaning set forth in Section 2.4.2.
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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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Regulatory Transfer has the meaning set forth in Section 3.2.3.
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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 Floodway means the channel of a river or other watercourse and the adjacent land areas that must be reserved in order to discharge the base flood without cumulatively increasing the water surface elevation more than a designated height.

  • 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 Corporation’s reasonable determination that as a result of any (i) amendment to, or change (including any announced prospective 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 shares of Series N Preferred Stock; (ii) proposed change in those laws or regulations that is announced or becomes effective after the initial issuance of any shares of Series N Preferred Stock; or (iii) 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 shares of Series N Preferred Stock, there is more than an insubstantial risk that the Corporation will not be entitled to treat the full liquidation preference amount of all shares of Series N Preferred Stock then outstanding as Tier 1 capital (or its equivalent) for purposes of the capital adequacy guidelines or regulations of the appropriate federal banking agency, as then in effect and applicable, for as long as any share of Series N 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 federal, national, multinational, state, county, city, provincial, or local regulatory agency, department, bureau or other governmental entity with authority over the marketing, commercialization, manufacture or sale of a pharmaceutical product in the Territory, including the FDA in the United States and the EMA in the EU.

  • 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.

  • Unproven/ Experimental treatment means the treatment including drug experimental therapy which is not based on established medical practice in India.

  • 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 any and all approvals (including MAA Approval, and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits, notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a Product in any 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, when used with respect to any Insurance Subsidiary, the insurance department or similar administrative authority or agency located in (x) the state or other jurisdiction in which such Insurance Subsidiary is domiciled or (y) to the extent asserting regulatory jurisdiction over such Insurance Subsidiary, the insurance department, authority or agency in each state or other jurisdiction in which such Insurance Subsidiary is licensed, and shall include any Federal insurance regulatory department, authority or agency that may be created in the future and that asserts regulatory jurisdiction over such Insurance Subsidiary.

  • Marketing Authorization means all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport, marketing and sale of Licensed Products in a country or regulatory jurisdiction.

  • 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 regulatory applications, submissions, notifications, registrations, Marketing Authorizations or other written materials, correspondence, submissions made to or with a Regulatory Authority that are necessary or reasonably desirable in order to Develop, Manufacture or Commercialize the Licensed Products in the Field in a particular country.

  • Nationwide Mortgage Licensing System and Registry means a mortgage licensing system developed and maintained by the conference of state bank supervisors and the American association of residential mortgage regulators for the licensing and registration of licensed mortgage loan originators.