Regulatory Review Period definition

Regulatory Review Period means the period of time defined in 35 U.S.C. § 156(g) and applicable to any Licensed Product;
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Regulatory Review Period means the period from the date on which the Regulators’ Draft is submitted to ASIC to the date on which ASIC approves in writing the form of the Scheme Booklet.
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Regulatory Review Period means the period from the date on which the Regulators' Draft is submitted to ASIC to the date on which ASIC provides a letter under section 411(1 7)(b) of the Corporations Act stating that ASIC has no objection to the Scheme.
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Examples of Regulatory Review Period in a sentence

  • Average transaction deposits increased $212 million from the second quarter of 2014 primarily driven by higher money market account and demand deposit balances, partially offset by lower savings, foreign office, and interest checking balances.

  • Except as may otherwise be contemplated under this Agreement with respect to the transfer of rights or obligations to Affiliates, Sublicensees and permitted assignees, ACORDA may not transfer, assign, license, mortgage or hypothecate in whole or in part to any person, whether voluntarily or involuntarily, its right to a Regulatory Review Period for any Licensed Product without the prior written consent of MAYO, which consent shall not be unreasonably withheld or delayed.

  • If such Agencies have not filed for an injunction enjoining the Parties from entering into this Agreement or the License Agreement before the end of the Regulatory Review Period, then the Parties shall then take all actions described in Paragraph 4 of this Agreement.

  • Determination of Regulatory Review Period for Purposes of Patent Extension; ZOLGENSMA at 33308 (Novartis Tab 1) with Novartis’s Comment at 3-4.

  • FDA–2016–E–1234 and FDA– 2016–E–1257] Determination of Regulatory Review Period for Purposes of Patent Extension; CORLANORAGENCY: Food and Drug Administration, HHS.ACTION: Notice.SUMMARY: The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CORLANOR and is publishing this notice of that determination as required by law.

  • E6–16216 Filed 9–29–06; 8:45 am]BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration[Docket No. 2006E–0050] Determination of Regulatory Review Period for Purposes of Patent Extension; BYETTAAGENCY: Food and Drug Administration, HHS.ACTION: Notice.SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for BYETTA and is publishing this notice of that determination as required by law.

  • Federal Register Notice of Determination of Regulatory Review Period On June 24, 2021, in response to PTO’s request, FDA published a notice of determination of the Zolgensma regulatory review period for the REGENXBIO PTE application.9 The notice, which does not apply certain statutory limitations, concluded that the maximum potential length of a patent extension is 2,088 days.

  • The Parties, upon mutual agreement in writing, may extend this Regulatory Review Period.

  • Determination of Regulatory Review Period for Purposes of Patent Extension; ZOLGENSMA, 86 Fed.

  • Furthermore, any interested person may petition FDA forDEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration [Docket No. 00E–1239] Determination of Regulatory Review Period for Purposes of Patent Extension; RapamuneAGENCY: Food and Drug Administration, HHS.ACTION: Notice.SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for Rapamune and is publishing this notice of that determination as required by law.


More Definitions of Regulatory Review Period

Regulatory Review Period shall be the period of time defined in 35 U.S.C. §156(g) and applicable to any FDA Product.
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Regulatory Review Period means the period
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Related to Regulatory Review Period

  • Review Period has the meaning set forth in Section 2.04(c)(i).

  • Title Review Period shall have the meaning set forth in Section 4.3.

  • Participating Certified Clinical Nurse Specialist means a Certified Clinical Nurse Specialist who has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Application Review Start Date means the later date of either the date on which the District issues its written notice that the Applicant has submitted a completed Application or the date on which the Comptroller issues its written notice that the Applicant has submitted a completed Application and as further identified in Section 2.3.A of this Agreement.

  • Non-Participating Certified Clinical Nurse Specialist means a Certified Clinical Nurse Specialist who does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Study Period means the period commencing at 9:00 a.m. on the date hereof, and continuing through 5:00 p.m. on the Closing Date.

  • JCC has the meaning set forth in Section 3.1.

  • Inspection Period means the period beginning on the Effective Date and expiring at 5:00 p.m. eastern time on the forty-fifth day after the Effective Date.

  • 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).

  • JDC has the meaning set forth in Section 3.2.

  • JMC has the meaning set forth in Section 3.2(a).

  • Participating Clinical Professional Counselor means a Clinical Professional Counselor who has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Examination Period means the last ten reporting cycles including the reporting cycle in which the involuntary examination is commenced except for instruments evidencing ownership, or rights to them or funds paid toward the purchase of them, or any dividend, capital credit, profit, distribution, interest, or payment on principal or other sum, held or owed by a holder, including funds deposited with a fiscal agent or fiduciary for payment of them, or pertaining to debt of a publicly traded corporation.

  • Dispute Period shall have the meaning specified in Section 9.3(a).

  • JSC has the meaning set forth in Section 3.1.

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Expedited review means an examination, in accordance with

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

  • Dispute Notice means a written notice served by one Party on the other stating that the Party serving the notice believes that there is a Dispute;

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

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

  • Engineer’s Representative means the official in the civil/ electrical engineering department who is authorized to be in-charge of the work to which these presents relate. It shall include any other official nominated to attend to the supervision of day to day execution of the work to which this CONTRACT relates.