Regulatory Transition Date definition

Regulatory Transition Date means, on a Product-by-Product and country-by-country basis, the date on which the relevant Regulatory Approval for the applicable Product in the applicable country and applicable requirements under the relevant applicable Laws respect of such Product in the applicable country are transferred from the relevant Seller that holds the existing Regulatory Approval to Buyer (or its Affiliate), and Buyer (or Affiliate) takes over all regulatory responsibilities for that Product in respect of such Product in such country as holder of a Buyer Marketing Authorization with respect to such Product in such country.
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Regulatory Transition Date has the meaning set forth in Section 4.1 1.169 […***…].
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Examples of Regulatory Transition Date in a sentence

  • Following the Regulatory Transition Date, Gilead shall provide Galapagos with reasonable advance notice of all formal meetings and teleconferences with the FDA and EMA pertaining to any Licensed Product, or with as much advance notice as practicable under the circumstances.

  • Following the Regulatory Transition Date, Gilead will be solely responsible for all regulatory matters relating to any Licensed Product or Gilead Combination Product in the Territory, and shall use Commercially Reasonable Efforts with respect to such regulatory matters for the first Licensed Product in each Major Market in each Target Indication, and Galapagos shall use Commercially Reasonable Efforts as requested by Gilead to assist Gilead with such regulatory matters.

  • Subject to ARTICLE VII, for each Optioned Program, unless otherwise agreed by the Parties in writing, following the Regulatory Transition Date, each Party shall be solely responsible for all regulatory matters (including applications for Regulatory Approval and communications with Regulatory Authorities) and the conduct of all Clinical Trials in its Respective Territory.

  • Without limiting the terms of the Asset Purchase Agreement, (i) the transfer of the Acquired Product Registrations to be effectuated in each applicable country or territory to Kamada or its Affiliate, including the Regulatory Transition Date for each applicable country and (ii) the Transition Services to be provided by Saol in respect of regulatory matters prior to the Regulatory Transition Date in each applicable country, are set forth in Exhibit A hereto.

  • For the purpose of this Section 5.2(f), “Gilead IND” means INDs that are filed after the Regulatory Transition Date with respect to an Optioned Product, and any supplements to an IND that has been requested by and transferred to Gilead pursuant to Section 5.2(b)(i)(A).

  • Features such as lintels, brackets, and columns were constructed with materials and finishes that are associated with particular styles, and are character-defining features as well.

  • Following the Regulatory Transition Date, within […***…] days after receipt of any Material Communication from a Regulatory Authority in a Major Market with respect to any Licensed Product, Gilead will provide Galapagos, through its Alliance Manager, with a brief written description of the principal issues raised in such Material Communication.

Related to Regulatory Transition Date

  • SOFR Benchmark Transition Event means the occurrence of a Benchmark Transition Event with respect to the then-current Benchmark;

  • Benchmark Transition Event means the occurrence of one or more of the following events with respect to the then-current Benchmark:

  • Benchmark Transition Start Date means, in the case of a Benchmark Transition Event, the earlier of (a) the applicable Benchmark Replacement Date and (b) if such Benchmark Transition Event is a public statement or publication of information of a prospective event, the 90th day prior to the expected date of such event as of such public statement or publication of information (or if the expected date of such prospective event is fewer than 90 days after such statement or publication, the date of such statement or publication).

  • Regulatory Exclusivity Period means, with respect to each Licensed Product in any country in the Territory, a period of exclusivity (other than Patent exclusivity) granted or afforded by Applicable Law or by a Regulatory Authority in such country that confers exclusive marketing rights with respect to such Licensed Product in such country or prevents another Person from using or otherwise relying on any data supporting the approval of the Drug Approval Application for such Licensed Product to support an application for regulatory approval of another product for any indication without the prior written consent of the Drug Approval Application holder.

  • Term SOFR Transition Event means the determination by the Administrative Agent that (a) Term SOFR has been recommended for use by the Relevant Governmental Body, (b) the administration of Term SOFR is administratively feasible for the Administrative Agent and (c) a Benchmark Transition Event or an Early Opt-in Election, as applicable, has previously occurred resulting in a Benchmark Replacement in accordance with Section 2.14 that is not Term SOFR.

  • Contract Transition Period means the 90 day transition as defined in Section F of this Contract.

  • 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 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.

  • New Services Queue Closing Date means each April 30 and October 31 shall be the Queue Closing Date for the New Services Queue comprised of Interconnection Requests, Completed Applications, and Upgrade Requests received during the six-month period ending on such date. “New York ISO” or “NYISO” shall mean the New York Independent System Operator, Inc. or any successor thereto.

  • Transition Date means the date on which this contract comes into effect for all purposes.

  • Application Approval Date means the date that the Application is approved by the Board of Trustees of the District and as further identified in Section 2.3.B of this Agreement.

  • Regulatory entity means any board, commission, agency,

  • Acquisition Period means the period ending five (5) business days prior to

  • Regulatory Capital Event means the good faith determination by the Company that, as a result of (i) any amendment to, clarification of, 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 the Series A Preferred Stock, (ii) any proposed change in those laws or regulations that is announced or becomes effective after the initial issuance of any share of the Series A 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 or policies with respect thereto that is announced after the initial issuance of any share of the Series A Preferred Stock, there is more than an insubstantial risk that the Company will not be entitled to treat the full liquidation preference amount of $25,000 per share of the Series A Preferred Stock then outstanding as “tier 1 capital” (or its equivalent) for purposes of the capital adequacy guidelines of the Federal Reserve (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 so long as any share of the Series A Preferred Stock is outstanding.

  • TARGET Business Day means a day on which the TARGET System is operating.

  • Control Appraisal Period shall exist with respect to the Mortgage Loan, if and for so long as:

  • SOFR Benchmark Replacement Date means the Benchmark Replacement Date with respect to the then-current Benchmark;

  • Benchmark Determination Date means (a) if the Benchmark is LIBOR, the LIBOR Determination Date, (b) if the Benchmark is Term SOFR, the date that is two Business Days before the first day of the applicable Accrual Period, (c) if the Benchmark is Compounded SOFR, the date that is five Business Days before the last day of the applicable Accrual Period and (d) if the Benchmark is any other rate, the date determined by the Trust according to Section 2.16 of the Indenture.

  • ECB Recommended Rate Index Cessation Event means the occurrence of one or more of the following events, as determined by the Issuer and notified by the Issuer to the Calculation Agent:

  • Non-Lead Securitization Determination Date means the “determination date” (or any term substantially similar thereto) as defined in the related Non-Lead Securitization Servicing Agreement.

  • Initial Negotiation End Date has the meaning set forth in Section 12.2(a).

  • Notification Date means 30 days from an Account statement date (see section 6.3).

  • Notification Time means 1:00 p.m., New York time, on a Local Business Day.

  • Ramp Period The Ramp Period begins on the Effective Date and ends after three (3) full months. At all times during the Ramp period, Customer will receive the rates, discounts, charges and credits in the agreement and will not be subject to an AVC. Annual Volume Commitment (“AVC”): Customer agrees to pay Company no less than $2,836,000 in Total Service Charges in each twelve-month period during the Initial Term (“Contract Year”), which is the Annual Volume Commitment (“AVC”).

  • Reference Interest Rate Transition Event means the occurrence of one or more of the following events with respect to the then-current Reference Interest Rate:

  • ECB Recommended Rate Index Cessation Effective Date means, in respect of an ECB Recommended Rate Index Cessation Event, the first date on which the ECB Recommended Rate is no longer provided, as determined by the Issuer and notified by the Issuer to the Calculation Agent;