PoC Trial Report definition

PoC Trial Report shall have the meaning assigned to such term in Section 4.2.1.
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PoC Trial Report has the meaning set forth in Section 3.6.3.
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PoC Trial Report means the final study report from the Phase 2 POC Trial by the trial investigators, including completed case report forms for all patients who participated in the ▇▇▇▇▇ ▇ ▇▇▇ ▇▇▇▇▇. For purposes of this definition, the study report shall be deemed “final” at such time as such report is in the form that will be filed with the FDA and Xencor has no further comments to such report and accepts such report as final.
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Examples of PoC Trial Report in a sentence

  • Unless otherwise agreed to by the Parties, the JRC will schedule an ad hoc meeting not more than [***] after receipt of any such PoC Trial report to review such PoC Trial Report and determine whether or not such Collaboration Compound meets the PoC Compound Criteria.

  • The JSC shall have a period of [***] after receipt of such PoC Trial Report to review, comment and agree on whether such Candidate Selection Compound in such PoC Trial has met the PoC Criteria.

  • Regulus shall endeavor in good faith to provide GSK with a reasonably accurate estimate of the time that the PoC Trial Report will be available at least [...***...] months in advance.

  • Unless otherwise agreed to by the Parties, the JRC will schedule an ad hoc meeting not more than [ * ] after receipt of any such PoC Trial Report to review such PoC Trial Report and other relevant information.

  • The Option shall have a term of [********] from the date of delivery of the PoC Trial Report for the relevant EPIX Program (the "Option Period"), subject to extension of the Option Period as provided in Section 4.1.

  • Unless otherwise agreed to by the Parties, the JRC will schedule an ad hoc meeting not more than thirty [ * ] after receipt of such PoC Trial Report to review such PoC Trial Report and determine whether or not such Candidate Selection Compound meets the PoC Compound Criteria.

  • Targacept shall endeavor to provide GSK with a good faith estimate of the time that such PoC Trial Report will be available at least [********] in advance.

  • Regulus shall endeavor in good faith to provide GSK with a reasonably accurate estimate of the time that the PoC Trial Report will be available at least [***] months in advance.

  • The Research Collaboration shall commence at the Effective Date and shall expire upon the earlier of (a) Anacor’s completion of a PoC Trial and delivery of a PoC Trial Report to the JRC under Section 2.6.6(c), and (b) [ * ] after the Effective Date, unless extended upon Medicis’s election pursuant to Section 2.6.6(d), or unless earlier terminated as provided herein (the “Research Collaboration Term”).

  • For clarity, the PoC Trial Report need not include the final report from any particular preclinical study or Clinical Study but shall include all resulting data and results reasonably expected to be pertinent to such decision.


More Definitions of PoC Trial Report

PoC Trial Report has the meaning assigned to such term in Section 2.6.5(c). [***] THE SYMBOL [***] IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTION.
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PoC Trial Report has the meaning assigned to such term in Section 2.6.6(c).
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Related to PoC Trial Report

  • Final Report means the report described as a final report in RCW 42.17A.235(11)(a).

  • Phase I Trial means a clinical trial of a Licensed Product in human patients designated as a Phase I Trial and conducted primarily for the purpose of determining the safety of and/or the metabolism and pharmacologic actions of the Licensed Product in humans, as described under 21 CFR § 312.21(a) (as hereafter modified or amended) and any of its foreign equivalents. For purposes of this definition, Phase I Trial shall specifically exclude trials in healthy volunteers.

  • Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

  • Root Cause Analysis Report means a report addressing a problem or non-conformance, in order to get to the ‘root cause’ of the problem, which thereby assists in correcting or eliminating the cause, and prevent the problem from recurring.

  • Financial Report means the annual financial report prepared under Chapter 2M of the Corporations Act for the Company and its controlled entities;