Phase IIIb Trial definition

Phase IIIb Trial means (a) a product support human clinical trial of a Licensed Product (i.e., a clinical trial that is not required for receipt of the first Approval of a Licensed Product for a particular indication in a country but which may be useful in providing additional drug profile data in support of such Approval of the Licensed Product for such indication) that is commenced before receipt of the first Approval of the Licensed Product for a particular indication in the country for which such trial is conducted or (b) a human clinical trial that is required or advised by a Regulatory Authority as a condition of or in connection with obtaining or maintaining the first Approval of a Licensed Product for a particular indication (whether commenced prior to or after receipt of such Approval).
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Phase IIIb Trial means (a) a product support human clinical trial of a Licensed Product ( i.e., a clinical trial that is not required for receipt of the first Approval of a Licensed Product for a particular indication in a country but which may be useful in providing additional drug profile data in support of such Approval of the Licensed Product for such indication) that is commenced before receipt of the first Approval of the Licensed Product for a particular indication in the country for which such trial is conducted or (b) a human clinical trial that is required or advised by a Regulatory Authority as a condition of or in connection with obtaining or maintaining the first Approval of a Licensed Product for a particular indication (whether commenced prior to or after receipt of such Approval).
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Phase IIIb Trial means product support clinical trials of a Collaboration Product (i.e., a clinical trial which is not required for receipt of Regulatory Approval but which may be useful in providing additional drug profile data) commenced before receipt of Regulatory Approval.
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Examples of Phase IIIb Trial in a sentence

  • If a Phase IIIb Trial is included within the scope of Development pursuant to Section 3.2(e), then such Phase IIIb Costs shall be classified as Development Costs and shall be subject to the procedures set forth in Section 3.3(f) if the Parties have entered into a Phase III Loan which covers such Phase IIIb Trial or if Syrrx pays its half of such costs.

  • By way of example, a Phase IIIb Trial for non-insulin dependent type II diabetes with more advanced disease is an example of a Phase IIIb Trial that is highly supportive of an NDA for type II diabetes.

  • For some diseases, the Parties may, but shall not be obligated to, choose to treat a selected Phase IIIb Trial as falling within the scope of Development, such as when such Phase IIIb Trial is typically performed in the industry in order to support a NDA or to expand the product label.

  • All Phase IIIb Costs and Phase IV Costs shall be Post-Launch Product R&D Expenses, which are taken into account in the calculation of Product Profit, except for those Phase IIIb Costs incurred with respect to a Phase IIIb Trial that the Parties mutually agree to include within the scope of Development pursuant to Section 3.2(e).

  • Within [*] after the JOC has agreed upon the Development Budget for a Phase IIIa Trial (and Phase IIIb Trial, if applicable) for a Collaboration Product (the “Due Diligence Period”), PPD shall conduct its due diligence upon Syrrx, Syrrx’s financial condition, the Collateral (as defined in Section 4.4(h)) and other matters.

  • For clarity, if the Parties are unable to agree whether to include a Phase IIIb Trial within the scope of Development, the dispute will not be subject to arbitration under Article 16 and the Phase IIIb Costs will be deemed to be part of Commercialization.

  • In the event that the Parties mutually agree to discontinue pursuing any further development of a Collaboration Product, repayment of the principal of the Phase III Loan shall commence on the first day of the first calendar month following the [*] anniversary of the last administration under the Phase IIIa Trial (or Phase IIIb Trial, if applicable) (the “Discontinued Development Commencement Date”) and continue on the same date of each month thereafter.


More Definitions of Phase IIIb Trial

Phase IIIb Trial means a pivotal Clinical Trial of the Product that is initiated following submission of a marketing application but prior to receipt of Marketing Approval for the Indication(s) being studied.
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