Regulatory Approval Period definition

Regulatory Approval Period means the period between execution of this Agreement and the receipt of all Regulatory Approvals, including the expiration of any notice periods set forth therein.
Sample 1
Regulatory Approval Period means with respect to any proposed Transfer of Shares or issuance of New Shares, (i) in the event that the approval of the IURC is required to consummate such Transfer or issuance, the period beginning on the date a definitive agreement is executed with respect to such Transfer or issuance and ending on the date that is two hundred seventy (270) days thereafter and (ii) in the event that the approval of the IURC is not required to consummate such Transfer or issuance, the period beginning on the date a definitive agreement is executed with respect to such Transfer or issuance and ending on the date that is one hundred eighty (180) days thereafter; provided, however, that in each case, such period shall be extended up to an additional three hundred sixty-five (365) days so long as the parties to the proposed Transfer or issuance have used and continue to use their reasonable best efforts to obtain any required regulatory approvals, but such approvals have not been obtained.
Sample 1
Regulatory Approval Period means, with respect to any proposed Transfer of Units or issuance of New Units, the period beginning on the date a definitive agreement is executed with respect to such Transfer or issuance and ending on the date that is one hundred eighty (180) days thereafter; provided, however, that in each case, such period shall be extended up to an additional ninety (90) days so long as the parties to the proposed Transfer or issuance have used and continue to use their reasonable best efforts to obtain any required regulatory approvals, but such approvals have not been obtained.
Sample 1

Examples of Regulatory Approval Period in a sentence

  • In the event that Buyer is unable to acquire all necessary approvals within the Regulatory Approval Period, as it may be extended, Buyer shall be permitted to cancel this Agreement by providing written notice of said cancellation to Seller during this period, in which case this Agreement shall become null and void.

  • Notwithstanding the foregoing, however, the Assignee shall have the right to terminate this Assignment on or before thirty (30) days from the Effective Date (the "Regulatory Approval Period") in the event the Assignee is not able to obtain, or is denied, approval from the Office of the Comptroller of the Currency and/or the requisite regulatory agency of the State of Maryland (collectively, the "Regulatory Approvals") before the expiration of the Regulatory Approval Period.

  • A constitutionally validated independence referendum in Scotland last Septem- ber was narrowly lost (55-45%), while a constitutionally non-validated plebiscite40 in Catalonia a few weeks later actually favoured independence.

  • During the Regulatory Approval Period (as defined below) and the Additional One Year Period (as defined below), the Buyer may assign the 51% Call Option and/or the Note to any third party.


More Definitions of Regulatory Approval Period

Regulatory Approval Period shall have the meaning ascribed to such term in Section 3.5(a) of the Disclosure Letter. "Remaining Facilities" shall have the meaning ascribed to such term in Section 1.2 of the Disclosure Letter. [Washington DC #361873 v9] 87 "Required Information" shall have the meaning ascribed to such term in Section 5.7(d) hereof.
Sample 1

Related to Regulatory Approval Period

  • Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.

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

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • 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 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.

  • 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.

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

  • FDA Approval means the approval by the FDA of a premarket approval application to market and sell a Product, as evidenced by the publication of such approval by the FDA.

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • 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;

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

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

  • Product Approval means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).

  • 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 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.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.

  • Pricing Approval means any approval, agreement, determination, or decision establishing prices that can be charged to consumers for a pharmaceutical or biological product or that will be reimbursed by Governmental Authorities for a pharmaceutical or biological product, in each case, in a country where Governmental Authorities approve or determine pricing for pharmaceutical or biological products for reimbursement or otherwise.

  • 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.

  • 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).

  • IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

  • Development approval means any written authorization from a

  • 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.

  • 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.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.