Regulatory Exception definition

Regulatory Exception means any action that could reasonably be expected to result in a violation of any provision of federal, state, or local law or regulation applicable to any Grantor or Subsidiary of a Grantor, any order, writ, judgment, injunction or decree of any court or other Governmental Authority binding on any Grantor or Subsidiary of a Grantor, or any contract between a Grantor or Subsidiary of a Grantor with any Governmental Authority (including any such agreement that limits sharing of any information) other than any such contracts entered into for purposes of avoiding compliance with any representation and warranty, covenant or other provision in this Agreement. In the event that a Government Contract contains restrictions on disclosure of classified information (as that term is defined in the National Industrial Security Program Operating Manual (DoD 5220.22-M)), information identified on a DD Form 254, or a clause such as DFARS 252.204-7004, and such information is required in order to complete the notices and assignment of such Government Contract pursuant to the Federal Assignment of Claims Act and such Government Contract requires government approval for release of the information by the Grantor or a Subsidiary of Grantor outside of the Grantor or a Subsidiary of Grantor, the Grantor or Subsidiary of Grantor will promptly undertake the procedures set forth in the Government Contract, applicable government regulation or guidance, or clause, to request the required government approval for such disclosure. In the event Collateral Agent or Grantor seeks to file a Notice of Assignment and the Instrument of Assignment with the federal government pursuant to the Assignment of Claims Act with respect to a Government Contract, the Grantor agrees to cooperate with the Collateral Agent to submit such Notice of Assignment and Instrument of Assignment to the federal government. If pursuant to Federal Acquisition Regulation (“FAR”) 52.232-23(c), submission of such Notice of Assignment and Instrument of Assignment requires the disclosure of classified information, the Grantor agrees to immediately seek the authorization of the contracting officer with authority for the contract as set forth in FAR 52.232-23(c) in order to effect the filing of such Notice of Assignment.
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Regulatory Exception means any action that would, in the good faith determination of Borrower, be inconsistent with (i) any applicable law, rule or regulation (or any policy interpretation of any governmental or other regulatory authority relating thereto) that is applicable to Borrower, any of its Subsidiaries or any of their respective businesses or assets, including, without limitation, any law, rule or regulation relating to export controls and (ii) any agreement with any Governmental Authority to which Borrower or any of its Subsidiaries is a party (including any such agreement that limits sharing of any information) other than any such agreements entered into for purposes of avoiding compliance with any representation and warranty, covenant or other provision in this Agreement.
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Examples of Regulatory Exception in a sentence

  • Notwithstanding anything set forth in this Agreement to the contrary, the Grantor shall not be required to register, or disclose any information which would result in a Regulatory Exception, provided that Grantor provide notice to Collateral Agent of any such determination along with such additional information as the Collateral Agent may reasonably request to verify to their satisfaction that such information is subject to a Regulatory Exception.

  • The provisions of this Section 5.6 shall be subject to the Regulatory Exception in all respects.

  • Each Material Contract existing on the Closing Date is listed on Schedule 4.16 (other than any Material Contract subject to a Regulatory Exception).

  • AstraZeneca also submitted a markup of the form of merger agreement, which accepted the Regulatory Exception and ZS Pharma’s proposed approach regarding antitrust matters, but did not accept the IP Exception.

  • The revised draft merger agreement included the same version of the Regulatory Exception and the IP Exception and the same risk allocation regarding antitrust matters as were included in ZS Pharma’s initial draft.

Related to Regulatory Exception

  • 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 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 which confers an exclusive Commercialization period during which AbbVie or its Affiliates or Sublicensees have the exclusive right to market and sell a Licensed Compound or Licensed Product in such country through a regulatory exclusivity right.

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

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • 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.

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities as set out in Schedule C hereto;

  • Regulatory Approvals means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

  • CFIUS Approval means that any of the following shall have occurred: (a) the review period under the DPA commencing on the date that a CFIUS Notice is accepted by CFIUS shall have expired and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS to the effect that such review has been concluded and that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, (b) an investigation under the DPA shall have been commenced after such review period and CFIUS shall have determined to conclude all action under the DPA without sending a report to the President of the United States, and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, or (c) CFIUS shall have sent a report to the President of the United States requesting the President’s decision and either (i) the President shall have announced a decision not to take any action to suspend or prohibit the Contemplated Transactions or, (ii) the period under the DPA during which the President may announce his decision to take action to suspend, prohibit or place any limitations on the Contemplated Transactions shall have expired without any such action being threatened, announced or taken.

  • Regulatory Permits means all Permits granted by the FDA or any comparable Governmental Entity to the Company or any of its Subsidiaries, including investigational new drug applications, Biologics License Applications, manufacturing approvals and authorizations, clinical trial authorizations and ethical reviews, or their national or foreign equivalents.

  • 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.

  • 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.

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • Regulatory Conditions means the conditions set out in paragraphs 3.3 to 3.5 (inclusive) of Part A of Appendix I to the Announcement;

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Licensed Product as a drug in a 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.

  • Property Reinvestment Application means, with respect to any Transfer of property, the application of an amount equal to the Net Proceeds Amount with respect to such Transfer to the acquisition by the Company of operating assets of the Company to be used in the principal business of the Company.

  • Environmental Approval means any consent, authorisation, licence or approval of any governmental or public body or authorities or courts applicable to any Relevant Ship or its operation or the carriage of cargo and/or passengers thereon and/or the provision of goods and/or services on or from any Relevant Ship required under any Environmental Law;

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • 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.

  • Product Approval(s) means any approvals, registrations, permits, licenses, consents, authorizations, and other approvals, and pending applications and requests therefor, required by applicable Agencies related to the research, Development, manufacture, distribution, finishing, packaging, marketing, sale, storage or transport of a Product within the United States of America, and includes, without limitation, all approvals, registrations, licenses or authorizations granted in connection with any Application related to that 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.

  • 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 entity means any board, commission, agency,