PoC Trial Reports Sample Clauses

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.
Sample 1Sample 2
AutoNDA by SimpleDocs
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.
Sample 1
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”).
Sample 1
PoC Trial Reports 
Sample 1Sample 2Sample 3

Related to PoC Trial Reports

  • 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”):

  • Actuarial Reports Promptly upon receipt thereof by any Loan Party or any ERISA Affiliate, a copy of the annual actuarial valuation report for each Plan the funded current liability percentage (as defined in Section 302(d)(8) of ERISA) of which is less than 90% or the unfunded current liability of which exceeds $5,000,000.

  • 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.

  • Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.

  • Annual Reports As soon as practicable, and in any event within ninety (90) days after the end of each fiscal year, (i) the consolidated balance sheet of the Company and its Subsidiaries as at the end of such fiscal year and the related consolidated statements of income, stockholders’ equity and cash flows of the Company and its Subsidiaries for such fiscal year, and in comparative form the corresponding figures for the previous fiscal year along with consolidating schedules in form and substance sufficient to calculate the financial covenants set forth in Section 7.18 and (ii) an audit report on the consolidated financial statements (but not the consolidating financial statements or schedules) listed in clause (i) hereof of independent certified public accountants of recognized national standing, which audit report shall be unqualified and shall state that such financial statements fairly present the consolidated financial position of the Company and its Subsidiaries as at the dates indicated and the results of their operations and cash flows for the periods indicated in conformity with Agreement Accounting Principles and that the examination by such accountants in connection with such consolidated financial statements has been made in accordance with generally accepted auditing standards. The deliveries made pursuant to this clause (ii) shall be accompanied by (x) any management letter prepared by the above-referenced accountants, and (y) a certificate of such accountants that, in the course of their examination necessary for their certification of the foregoing, they have obtained no knowledge of any Default or Event of Default, or if, in the opinion of such accountants, any Default or Event of Default shall exist, stating the nature and status thereof.

  • Financial Reports Borrower shall furnish to Agent the financial statements and reports listed hereinafter (the “Financial Statements”):

  • Annual Compliance Statements (a) The Master Servicers, the Special Servicers, the Certificate Administrator, the Trustee (but only to the extent set forth in the last sentence of this paragraph), any Additional Servicer and each Servicing Function Participant (if such Servicing Function Participant is a servicer contemplated by Item 1108(a)(2)(i), (ii) or (iii) of Regulation AB) (each, a “Certifying Servicer”) shall and the Master Servicers and the Special Servicers shall (i) with respect to any Additional Servicer or Servicing Function Participant (if such Servicing Function Participant is a servicer contemplated by Item 1108(a)(2)(i), (ii) or (iii) of Regulation AB) that is a Designated Sub-Servicer of such party, use commercially reasonable efforts to cause, and (ii) with respect to any other Additional Servicer or Servicing Function Participant (if such Servicing Function Participant is a servicer contemplated by Item 1108(a)(2)(i), (ii) or (iii) of Regulation AB), cause, each Additional Servicer and Servicing Function Participant (other than any party to this Agreement) with which it has entered into a servicing relationship with respect to the Mortgage Loans to, deliver to the Depositor, the Certificate Administrator, the Trust Advisor (in the case of a Special Servicer only), the Rule 17g-5 Information Provider (who shall promptly post such report to the Rule 17g-5 Information Provider’s Website pursuant to Section 8.12(c) of this Agreement) on or before March 1st (subject to a grace period through March 15th) of each year, commencing in 2015 (or, in the case of an Additional Servicer or Servicing Function Participant with respect to a Special Servicer, such party shall provide such Officer’s Certificate to such Special Servicer on or before March 1st (subject to a grace period through March 5th)), an Officer’s Certificate stating, as to the signer thereof, that (A) a review of such Certifying Servicer’s activities during the preceding calendar year or portion thereof and of such Certifying Servicer’s performance under this Agreement, or the applicable sub-servicing agreement or primary servicing agreement in the case of an Additional Servicer, has been made under such officer’s supervision and (B) to the best of such officer’s knowledge, based on such review, such Certifying Servicer has fulfilled all its obligations under this Agreement, or the applicable sub-servicing agreement or primary servicing agreement in the case of an Additional Servicer, in all material respects throughout such year or portion thereof, or, if there has been a failure to fulfill any such obligation in any material respect, specifying each such failure known to such officer and the nature and status thereof. The Certificate Administrator, shall prior to March 1st of each year, commencing in 2015, contact the Trustee and inquire as to whether any Advance was required to be made by the Trustee during the preceding calendar year, and if no such Advance was required to be made by the Trustee, then the Trustee shall not be required to deliver any compliance statement required by this Section 11.12(a) for such period.

Time is Money Join Law Insider Premium to draft better contracts faster.