Vaccine Approval Criteria definition

Vaccine Approval Criteria means the requirement that Project COVID-19 Vaccine: (a) has received regular or emergency licensure or authorization from at least one (1) of the Stringent Regulatory Authority identified by WHO for vaccines procured and/or supplied under the COVAX Facility, as may be amended from time to time by WHO; or (b) has received WHO Prequalification (PQ) or WHO Emergency Use Listing (EUL); or (c) has met such other criteria as may be agreed in writing between the Recipient and the Association.
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Vaccine Approval Criteria means that the Project COVID-19 Vaccine: (a) has received regular or emergency licensure or authorization from at least one of the Stringent Regulatory Authorities identified by WHO for vaccines procured and/or supplied under the COVAX Facility, as may be amended from time to time by WHO; (b) has received the WHO Prequalification or WHO Emergency Use Listing; or (c) has met such other criteria as may be agreed in writing between the Recipient and the Association.
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Vaccine Approval Criteria means that the Project COVID-19 Vaccine: (a) has been approved by three (3) Stringent Regulatory Authorities (including by Emergency Use Authorization) in two (2) Regions; or (b) has received the WHO Prequalification and has been approved (including by Emergency Use Authorization) by one (1) Stringent Regulatory Authority; or (c) has met such other criteria as may be agreed in writing between the Recipient and the Association.
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Examples of Vaccine Approval Criteria in a sentence

  • All Project COVID-19 Vaccines shall satisfy the Vaccine Approval Criteria.

  • All Project COVID-19 Vaccines to be purchased/procured under the Project shall satisfy the Vaccine Approval Criteria.

  • All Project COVID-19 Vaccines to be procured or administered under the Project shall satisfy the Vaccine Approval Criteria.

  • All Project COVID-19 Vaccine shall satisfy the Vaccine Approval Criteria.

  • All Project COVID-19 Vaccines to be procured under the Project shall satisfy the Vaccine Approval Criteria.

  • All Project COVID-19 Vaccine acquired under Part 1.1 of the Project shall satisfy the Vaccine Approval Criteria.


More Definitions of Vaccine Approval Criteria

Vaccine Approval Criteria means that the vaccine: (a) has been approved by three (3) Stringent Regulatory Authorities (including by Emergency Use Authorization) in two (2) Regions; or (b) has received the WHO Emergency Use Listing and has been produced with a licensing or similar arrangement from a manufacturer of a parent/bioequivalent vaccine that has received a prior Stringent Regulatory Authority approval (including Emergency Use Authorization); or (c) has met such other criteria as may be agreed in writing between the Recipient and the Association.
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Vaccine Approval Criteria means that the Project COVID-19 Vaccine: (a) has received regular or emergency licensure or authorization from at least one of the Stringent
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Vaccine Approval Criteria means that the Project COVID-19 Vaccine:
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Related to Vaccine Approval Criteria

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • 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 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Target Population means persons with low incomes who have one or more disabilities, including mental illness, HIV or AIDS, substance abuse, or other chronic health condition, or individuals eligible for services provided pursuant to the Lanterman Developmental Disabilities Services Act (Division 4.5 (commencing with Section 4500) of the Welfare and Institutions Code) and may include, among other populations, adults, emancipated minors, families with children, elderly persons, young adults aging out of the foster care system, individuals exiting from institutional settings, veterans, and homeless people.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.