Regulatory Denial definition

Regulatory Denial means (i) any required Regulatory Approval is denied or the applicable Regulatory Authority has indicated that such approval will be denied, (ii) any required Regulatory Approval that is subject to the imposition of conditions that the Beneficiary, by written notice to the Managing Trustee, has deemed to be unacceptable or the applicable Regulatory Authority has indicated that such approval will be subject to the imposition of conditions that the Beneficiary, by written notice to the Managing Trustee, has deemed to be unacceptable, or (iii) any required Regulatory Approval has not been obtained by the Outside Date.
Sample 1Sample 2
Regulatory Denial means that any regulatory authority which regulates the Company and/or any of its subsidiaries and/or operations (a “Regulatory Authority” and, collectively, “Regulatory Authorities”) has, following the earlier of (i) exhaustion
Sample 1
Regulatory Denial as used herein, shall mean any of (i) a denial of approval by either of the FTC or a state attorney general as to which neither party seeks further review or (ii) Sanofi’s election to terminate or not to continue (as referred to in paragraph 18(i)) the Regulatory Review or (iii) Sanofi’s option to continue Regulatory Review has expired at a time when Regulatory Clearance has not been obtained or (iv) Sanofi has elected to terminate this agreement after continuing negotiations with DRL pursuant to paragraph 12.
Sample 1

Examples of Regulatory Denial in a sentence

  • Pursuant to Section 1(a)(v) of the Agreement, immediately upon the occurrence of a Regulatory Denial, I irrevocably resign from my position as a director of the Company and from any and all committees of the Board on which I serve.

  • Pursuant to Section 1(a)(iv) of the Agreement, immediately upon the occurrence of a Regulatory Denial, I irrevocably resign from my position as a director of the Company and from any and all committees of the Board on which I serve.

  • In the event that the Beneficiary notifies the Managing Trustee in writing that there is a Regulatory Denial, the Trust shall use its commercially reasonable efforts to (i) sell the Shares to one or more third parties or (ii) otherwise dispose of the Shares in each case during a period of one year after such Regulatory Denial.

  • Furthermore, Ellison et al (2007) argued that people use social media to maintain their existing social networks instead of creating new ones.

  • Notwithstanding the foregoing, in no event shall the parties enter into an amendment, modification, supplement or otherwise alter Section 3 or Section 4 of this Agreement at any time prior to the earlier of (i) the receipt of any Required Regulatory Approval and (ii) Regulatory Denial.


More Definitions of Regulatory Denial

Regulatory Denial means that any regulatory authority which regulates the Company and/or any of its subsidiaries and/or operations (a “Regulatory Authority” and, collectively, “Regulatory Authorities”) has, following the earlier of (i) exhaustion of all available regulatory and subsequent court appeals processes, and (ii) January 1, 2025, (x) required the termination of one or more Icahn Designee (or any Replacement Designee) as a director of the Company, (y) denied or declined to grant any required approvals or clearances necessary to permit the Icahn Designee (or any Replacement Designee) to remain a director of the Company in accordance with this Agreement or (z) included an Unacceptable Condition (as defined below) to any such approval or clearance. “Unacceptable Condition” means any condition, term, commitment, sanction, undertaking, concession or requirement, including a divestiture, rate credit, rate change, operational investment, financial payment, governance requirement, subsidiary board of director change, audit, independent monitor, dividend restriction or limitation, or any ringfencing or financial protection condition, which, individually or in the aggregate, in the opinion of the Company or the Icahn Group, in each case acting reasonably and in good faith, would cause an effect that is more than de minimis on the Company, any of its subsidiaries or affiliates, or any member of the Icahn Group. In the event that any Regulatory Authority shall require the termination of one or more Icahn Designee (or any Replacement Designee) as a director of the Company, (x) each of the Company and the Icahn Group shall cooperate pursuant to Section 1(a)(vii) below to obtain all necessary Regulatory Approvals to permit such Icahn Designee(s) to promptly rejoin the Board and (y) in the interim, the Company shall appoint to the Board, in replacement of each such Icahn Designee, an independent director who is not affiliated with the Icahn Group and who is reasonably acceptable to both the Icahn Group and the Company, and who shall resign from the Board promptly upon such time, if any, that such Icahn Designee is permitted to rejoin the Board.
Sample 1
Regulatory Denial has the meaning set forth in Section 5.5(c)(ii).
Sample 1
Regulatory Denial means that a Regulatory Authority has, following the exhaustion of all available regulatory and subsequent court appeals processes, (x) required the termination of the Investor Nominee as a director of the Company, (y) denied or declined to grant any required approvals or clearances necessary to permit the Investor Nominee to remain a director of the Company in accordance this Agreement or (z) included an Unacceptable Condition to any such approval or clearance. “Unacceptable Condition” means any condition, term, commitment, sanction, undertaking, concession or requirement, including a divestiture, rate credit, rate change, operational investment, financial payment, governance requirement, subsidiary board of director change, audit, independent monitor, dividend restriction or limitation, or any ringfencing or financial protection condition, which, individually or in the aggregate, in the opinion of the Company or the Investor, in each case acting reasonably and in good faith, would cause a material and adverse effect on the Company, any of its Subsidiaries or Affiliates, or the Investor. In the event that any Regulatory Authority shall require the termination of the Investor Nominee as a director of the Company, (x) each of the Company and the Investor shall cooperate pursuant to Section 5.5(c)(iii) below to obtain all necessary Regulatory Approvals to permit such Investor Nominee to promptly rejoin the Board and (y) in the interim, the Company shall appoint to the Board, in replacement of the Investor Nominee, an independent director who is not Affiliated with the Investor and who is reasonably acceptable to both the Investor and the Company, and who shall resign from the Board promptly upon such time, if any, that such Investor Nominee is permitted to rejoin the Board.
Sample 1
Regulatory Denial as used herein, shall mean a denial of approval by either of the FTC or a state attorney general as to which neither party seeks further review. If Regulatory Review has not been completed by July 31, 2006, either party has the right to declare that there has been Regulatory Denial.
Sample 1

Related to Regulatory Denial

  • Regulatory Data means any and all research data, pharmacology data, chemistry, manufacturing, and control data, preclinical data, clinical data or all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product in the Field (including any Drug Master Files (DMFs), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation).

  • 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.

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

  • 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.

  • 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.

  • 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 Disruption Any event that Dealer, based on the advice of counsel, determines makes it reasonably necessary or appropriate with regard to any legal, regulatory or self-regulatory requirements or related policies and procedures that generally apply to transactions of a nature and kind similar to the Transaction and have been adopted in good faith by Dealer for Dealer to refrain from or decrease any market activity in connection with the Transaction. Settlement:

  • 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).

  • 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 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.

  • 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 Problem means any set of facts or circumstance wherein it has been asserted by any governmental regulatory agency (or a Regulated Stockholder reasonably believes that there is a risk of such assertion) that such Regulated Stockholder is not entitled to acquire, own, hold or control, or exercise any significant right (including the right to vote) with respect to, any Equity Securities of the Company or any subsidiary of the Company.

  • Regulatory Documents means the prospectus, annual report, semi-annual report and any other document required under applicable federal securities law to be delivered by the Trust to Fund shareholders.

  • 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.

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • 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;

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • Generic Drug means a Prescription Drug that is medically equivalent to a Brand Name Drug as determined by the FDA. It meets the same standards as a Brand Name Drug for purity, safety, strength and effectiveness and is manufactured and sold under its chemical, common, or official name.

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • Biosimilar Application has the meaning set forth in Section 7.3.3.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Regulatory Authorities means the Commissions and the Exchange;

  • Regulatory entity means any board, commission, agency,

  • Regulatory Filings means all applications, filings, dossiers and the like submitted to a Regulatory Authority in a particular jurisdiction for the purpose of obtaining Regulatory Approval of a Licensed Product from that regulatory authority with respect to such jurisdiction. Regulatory Filings shall include, but not be limited to, all INDs and Drug Approval Applications for Licensed Product.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.