Phase IIIb Clinical Trial means a clinical trial of a Product, initiated before regulatory approval and is not required for same, but which may provide data that further defines how and where the drug should be used. A Phase IIIb Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials that are approved by the JDC and that otherwise fit the foregoing definition.
Phase IIIb Clinical Trial means a clinical trial of a Licensed Product in human patients, which provides for product support (i.e., a clinical trial which is not required for receipt of initial Marketing Authorization but which may be useful in providing additional drug profile data or in seeking a label expansion) commenced before receipt of Marketing Authorization for the indication for which such trial is being conducted.
Phase IIIb Clinical Trial means a Phase III Clinical Trial commenced before receipt of Approval in the jurisdiction where such trial is being conducted, but which is not required for receipt of Approval and is conducted primarily for the purpose of IL-1 Product support (i.e., providing additional drug profile data).
Examples of Phase IIIb Clinical Trial in a sentence
Jennum, Early Automatic Detection of Parkinson ’ s Disease Based on Sleep Recordings, American Clinical Neurophisiology Society 31 (2014) 409–415.
More Definitions of Phase IIIb Clinical Trial
Phase IIIb Clinical Trial means a clinical trial of a Product, initiated before regulatory approval and is not required for same, but which may provide data that further defines how and where the drug should be used. A Phase IIIb Clinical Trial may be a clinical trial that is advised or required by a Regulatory Authority as a condition of or in connection with obtaining or maintaining Regulatory Approval (whether commenced prior to or after receipt of such Regulatory Approval). They may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials that are approved by the JDC and that otherwise fit the foregoing definition.
Phase IIIb Clinical Trial means a human clinical trial of a compound or product for an indication that (a) is not required for receipt of Regulatory Approval for such indication for a country but which may be useful in providing additional drug profile data in support of such Regulatory Approval or, as applicable, Pricing Approval (whether the trial is commenced prior to or after receipt of such Regulatory Approval), or (b) is required, requested or advised by a Regulatory Authority as a condition of, or in connection with, obtaining or maintaining such Regulatory Approval (whether the trial is commenced prior to or after receipt of such Regulatory Approval).
Phase IIIb Clinical Trial means one of those product-support clinical trials of a drug (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 or to support label expansion for such drug) commenced before receipt of Regulatory Approval in the country where such trial is being conducted.
Phase IIIb Clinical Trial means a human clinical trial of a Compound or Product for an indication that (a) is not required for receipt of Regulatory Approval for such indication for a country but which may be useful in providing additional drug profile data in support of such Regulatory Approval (whether the trial is commenced prior to or after receipt of such Regulatory Approval), or (b) is required, requested or advised by a Regulatory Authority as a condition of, or in connection with, obtaining or maintaining such Regulatory Approval (whether the trial is commenced prior to or after receipt of such Regulatory Approval). For clarity, for purposes of this Agreement, Phase IIIb Clinical Trials do not include clinical trials or other studies where a Product is used in such study as provided in Section 4.3(a)(iii).
Phase IIIb Clinical Trial means a product support human clinical trial of a Licensed Product (i.e., a clinical trial which is not required for receipt of Approval for a country but which may be useful in providing additional drug profile data) that is approved by the JDC and made part of the Development Plan and that is (i) commenced before receipt of Approval in the country for which such trial is conducted or (ii) is required or requested by a Regulatory Authority as a condition of or in connection with an Approval (whether commenced prior to or after receipt of Approval).
Phase IIIb Clinical Trial means (a) a product support human clinical trial of Final Product (i.e., a clinical trial that is not required for receipt of Approval for an Indication in Japan or new line of therapy within an Indication, but which may be useful in providing additional drug profile data in support of such Approval in Japan for such Indication or new line of therapy) that is commenced before receipt of Approval for such Indication (or new line of therapy) in Japan, or (b) a clinical trial that is required or advised by a Japanese Regulatory Authorities as a condition of or in connection with obtaining or maintaining a regulatory approval for an Indication or new line of therapy (and that is commenced after receipt of such regulatory approval).
Phase IIIb Clinical Trial means a human clinical trial of a compound or product for an indication that (a)(i) is not required for receipt of Regulatory Approval for such indication for a country but which may be useful in providing additional drug profile data in support of such Regulatory Approval (whether the trial is commenced prior to or after receipt of such Regulatory Approval), or (ii) is required, requested or advised by a Regulatory Authority as a condition of, or in connection with, obtaining or maintaining such Regulatory Approval (whether the trial is [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. commenced prior to or after receipt of such Regulatory Approval), and (b) is approved by the JDC and made part of the Long-Term Development Plan.