PoC Trial Reports Clause Samples

PoC Trial Reports. Within [***] after database lock of the PoC Trial for each Collaboration Program pursuant to the applicable Pre-Exercise Development Plan and Budget, Licensor shall provide or make available to AbbVie all raw Clinical Data generated in such PoC Trial that are available to Licensor. Within [***] after database lock of the PoC Trial for each Collaboration Program pursuant to the applicable Pre-Exercise Development Plan and Budget, Licensor shall provide AbbVie with a study report for such PoC Trial consisting of the Information, Clinical Data and supporting documentation set forth on Schedule 3.1.3, along with a quality assurance statement describing quality issues, if any, limiting the validity of the PoC Trial that were raised during its conduct, together with such other information as AbbVie may reasonably request in connection with its evaluation that (a) is in existence as of the date of delivery of the PoC Trial Report, (b) is reasonably accessible to Licensor, and (c) is reasonably necessary to make an informed decision as to whether to exercise the Option (the “PoC Trial Report”). In addition, following database lock of the PoC Trial, Licensor shall fully cooperate to permit AbbVie to conduct a reasonable and customary due diligence review with respect to such Licensed Product as is reasonably necessary to enable AbbVie to reach a decision of whether to exercise the Option. *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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PoC Trial Reports. Once a Development Candidate has been determined to meet the PoC Criteria by the JSC to be an Option Compound, Targacept shall, within [********] of such occurrence (unless impractical depending on the nature of the applicable PoC Trial and the data generated thereunder), provide or make available to GSK at Targacept’s offices or another mutually acceptable location a data package containing all analysis, results [********] from the PoC Trial for such Option Compound, as well as any previously undisclosed preclinical or clinical data generated or any related correspondence or information received from or sent to any Regulatory Authority relating to the Progressed Compounds then known to be subject to the Program Option, in each case to assist and enable GSK to make its decision on whether to elect to exercise its Program Option (the “PoC Trial Report”). 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. However, Targacept shall provide each applicable final report to GSK as soon as reasonably practicable following its receipt or completion by Targacept.
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PoC Trial Reports. 4.2.1 For Collaboration Compounds Other than CCX282. Once a Development Candidate has been determined to meet the PoC Criteria and the endpoints of the PoC Trial by the JSC, ChemoCentryx shall, within sixty (60) days of such occurrence (unless impractical depending on the nature of the trial and the data generated thereunder), provide a data package to GSK containing all analysis, results and raw data from the PoC Trial for such Option Compound, as well as any previously undisclosed preclinical data and/or clinical data generated or any -42- related correspondence or information received from or sent to any Regulatory Authority up to the completion of the PoC Trial relating to the Progressed Compounds at issue, in each case to assist and enable GSK to make its decision on whether to elect to exercise its Product Option with respect to such Option Compound and its associated Back-up Compounds, as Product Candidates for further development and commercialization (the “PoC Trial Report”).
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PoC Trial Reports 
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Related to PoC Trial Reports

  • Initial Report An initial performance report no later than 30 days after FEMA has approved the first Public Assistance project.

  • SPECIAL REPORTS Generate or develop and distribute special data, notices, reports, programs and literature required by Institutions or by Account holders generally in light of developments, such as changes in tax laws; and

  • Final Reports Within ninety (90) days of receipt of the Required Documents, the Asset Representations Reviewer shall publish its findings to the Sponsor and the Indenture Trustee. The Asset Representations Reviewer shall provide the Sponsor and the Indenture Trustee with the following reports as a result of the Asset Representations Review (collectively, the “Final Reports”):

  • Additional Reports Upon ADMINISTRATOR’s request, CONTRACTOR shall make such additional reports as required by ADMINISTRATOR concerning CONTRACTOR's activities as they affect the services hereunder. ADMINISTRATOR shall be specific as to the nature of information requested and allow up to thirty (30) calendar days for CONTRACTOR to respond.

  • Final Report The goal of this subtask is to prepare a comprehensive Final Report that describes the original purpose, approach, results, and conclusions of the work performed under this Agreement. The CAM will review the Final Report, which will be due at least two months before the Agreement end date. When creating the Final Report Outline and the Final Report, the Recipient must use the Style Manual provided by the CAM.