JJSI Clinical Data definition

JJSI Clinical Data means any and all Data obtained from an LC Study associated with JJSI Samples, including any clinical and demographic data (including health and disease history) and imaging data in the form of raw images and reports, and any other clinical data obtained from the enrolled patient, in each case that JJSI or a JJSI Affiliate is to provide or has provided to Veracyte as referenced in the Program Plan. “JJSI Clinical Data” includes data that ▇▇▇▇▇▇▇ Research & Development, LLC, may have previously provided to Veracyte under the MTA.
View Source

Examples of JJSI Clinical Data in a sentence

  • For clarity, JJSI hereby grants to Veracyte a right of reference to the JJSI Clinical Data, including the right to disclose in regulatory submissions, for the purpose of developing the Diagnostic Products under this Agreement, provided that Veracyte does not have the right to disclose any other JJSI Confidential Information in a regulatory submission without the written approval of JJSI.

Related to JJSI Clinical Data

  • Clinical Data means the information with respect to the Licensed Product or the Licensed Compound made, collected or otherwise generated under or in connection with pre-clinical, clinical, or the post-Approval studies for the Licensed Compound or Licensed Product, including any data, reports and results with respect to any of the foregoing.

  • 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).

  • 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 III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.