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
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Examples of Regulatory Review Period in a sentence

  • Regulatory Review Period means the period from the date on which the Regulator’s Draft is submitted to ASIC to the date on which ASIC confirms that it does not intend to make any submissions at the Court hearing on the First Court Date or otherwise object to the Scheme.

  • Regulatory Review Period means the period from the date on which the Target provides the Regulator's Draft to ASIC in accordance with clause 4.1(e) to the date on which ASIC provides a letter indicating whether or not it proposes to appear to make submissions, or will intervene to oppose the Scheme, when the application made to the Court for orders under section 411(1) of the Corporations Act convening the Scheme Meeting is heard.

  • Regulatory Review Period means the period from the date on which SKILLED provides the Regulator's Draft to ASIC in accordance with clause 4.2(i) to the date on which ASIC provides a letter indicating whether or not it proposes to appear to make submissions, or will intervene to oppose the Scheme, when the application made to the Court for orders under section411(1) of the Corporations Act convening the Scheme Meeting to consider the Scheme is heard.

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

  • Regulatory Review Period means the period from the date on which Target provides the Regulator's Draft to ASIC in accordance with clause 4.3(h) to the date on which ASIC provides a letter indicating whether or not it proposes to appear to make submissions, or will intervene to oppose the Scheme, when the application made to the Court for orders under section 411(1) of the Corporations Act convening the Scheme Meeting to consider the Scheme is heard.

  • DEPARTMENT OF HEALTH ANDHUMAN SERVICESFood and Drug Administration[Docket No. 2005E–0251] Determination of Regulatory Review Period for Purposes of Patent Extension; MYCAMINEAGENCY: Food and Drug Administration, HHS.ACTION: Notice.SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for MYCAMINE and is publishing this notice of that determination as required by law.

  • Regulatory Review Period means the period from the date on which Target provides the Regulator's Draft to ASIC in accordance with clause 4.4(i) to the date on which ASIC provides a letter indicating whether or not it proposes to appear to make submissions, or will intervene to oppose the Scheme, when the application made to the Court for orders under section 411(1) of the Corporations Act convening the Scheme Meeting to consider the Scheme is heard.

  • Patent Term Extensions (For Regulatory Review Period) (Article 20.F.11) 1.

  • Regulatory Review Period means the period from the date on which the Target provides the Regulator's Draft to ASIC in accordance with clause 4.1(h) to the date on which ASIC provides a letter indicating whether or not it proposes to appear to make submissions, or will intervene to oppose the Scheme, when the application made to the Court for orders under section 411(1) of the Corporations Act convening the Scheme Meeting to consider the Scheme is heard.

  • FDA–2016–E–1279 and FDA– 2016–E–1282] Determination of Regulatory Review Period for Purposes of Patent Extension; SAPIEN 3 TRANSCATHETER HEART VALVEAGENCY: Food and Drug Administration, HHS.ACTION: Notice.SUMMARY: The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SAPIEN 3 TRANSCATHETERHEART VALVE 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 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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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.

  • Supervisory Review means ongoing clinical case reviews in accordance with procedures developed by ADMINISTRATOR, to determine the appropriateness of Diagnosis and treatment and to monitor compliance to the minimum ADMINISTRATOR and Medi-Cal charting standards. Supervisory review is conducted by the program/clinic director or designee.

  • Ambulatory review means utilization review of health care services performed or provided in an outpatient setting.

  • 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 2.1.

  • 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, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • JDC has the meaning set forth in Section 3.2.

  • JMC has the meaning set forth in Section 3.01.

  • Xxxx Dispute Notice means the notice issued by a Party raising a Dispute regarding a Monthly Xxxx or a Supplementary Xxxx issued by the other Party;

  • 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 as defined in Section 4.01.

  • 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 study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • 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

  • Summary Subcontract Report (SSR) Coordinator, as used in this clause, means the individual at the department or agency level who is registered in eSRS and is responsible for acknowledging or rejecting SSRs in eSRS for the department or agency.

  • 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.