Reports; Results Sample Clauses
Reports; Results. Until the end of the Research Term, each Party shall provide written progress reports on the status of its activities under Research Plans during the Collaboration, on a Selected Target-by-Selected Target basis, including detailed summaries of data associated with such activities and, in the case of EPIZYME, reasonably detailed summaries of data generated in the course of its ongoing platform discovery activities to the extent not previously provided to GSK and relevant to the identification or attractiveness for selection of potential Available Targets under Section 2.2, at least [**] Business Days in advance of each JPT meeting.
Reports; Results. Each Party shall provide to the other Party quarterly written progress reports on the status of its Development activities under the Collaboration, including summaries of data and results associated with such Development activities, and (with respect to EPIZYME) progress toward completing the milestones in Section 6.3 hereof, at least five (5) Business Days in advance of each JSC meeting.
Reports; Results. Each Party shall maintain complete, current and accurate records of all research, Development and Manufacturing activities conducted by it hereunder, and all data and other information resulting from such activities. Such records shall fully and properly reflect all work done and results achieved in the performance of the research and Development activities in good scientific manner appropriate for regulatory and patent purposes. Each Party shall document all IND-Enabling Studies and Clinical Trials in formal written study records according to applicable Laws, including national and international guidelines such as ICH, GCP, GLP and GMP. Each Party shall have the right to review and copy such records maintained by the other Party at reasonable times, as reasonably requested by a Party. At least [***] in advance of each JSC meeting and subject to Section 2.2.4, each Party shall provide the JSC written progress reports on the status of such Party’s material activities under each Program during the Collaboration prepared in a manner consistent with such Party’s customary internal procedures for preparing such reports, including (a) the identification of any Collaboration Candidates that are being pursued by Jounce under this Agreement, and Development Candidates, and (b) reasonably detailed summaries of data associated with such Party’s material activities with respect to each Program. In addition, at any time upon Celgene’s reasonable request and subject to Section 2.8.1, Jounce shall provide Celgene with reasonable CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. quantities of any Collaboration Candidates that are not Development Candidates, and related Diagnostic Products.
Reports; Results. Until achievement of Proof of Concept of a Licensed Compound, each Party shall provide [**] written progress reports on the status of its Development activities under the Collaboration, including summaries of data and results associated with such Development activities, progress toward completing milestones in Section 7.3 hereof, and, with respect to EISAI, all information described in Section 6.1.2 for the period covered by such report, at least [**] Business Days in advance of each JSC meeting.
Reports; Results. After achievement of Proof of Concept of a Licensed Compound, EISAI shall provide EPIZYME with periodic written reports summarizing in reasonable detail (to the extent applicable) the material activities and anticipated plans of EISAI, its Affiliates and Sublicensees with respect to the Development and Commercialization of such Licensed Compound, any Therapeutic Product or Veterinary Product comprising such Licensed Compound and any related Diagnostic Product(s) (in each case excluding Shared Products, which are addressed in Article 6) in the Field in the Territory, by each Major Market Country and the rest of the world in which the foregoing activities are conducted, such information to be provided for each Licensed Compound. Such written reports shall be provided to EPIZYME at least once every [**] months (and reasonably in advance of each [**] meeting of the Parties held in accordance with Section 3.3).
Reports; Results. At each meeting of the JSC or as otherwise agreed by the Parties, Company will provide the JSC with written reports or presentations identifying each Collaboration Candidate or potential Drug Candidate under Development by Company and its Affiliates and summarizing the results, information, data generated by and material developments, including any Significant Developments, with respect to each Collaboration Program.
Reports; Results. 2.5.1 Until the end of the Research Term, each Party shall provide written progress reports on the status of its activities under Research Plans during the Collaboration, on a Selected Target-by-Selected Target basis, including detailed summaries of data associated with such activities, at least [**] Business Days in advance of each JPT meeting. Without limiting the foregoing, EPIZYME shall deliver to GSK all data, reports and other results, and analyses thereof, specifically set forth in Appendix A, related to the “Lead Compounds” defined as those Lead Candidate Compounds that are under consideration for designation as Development Candidates generated in the course of performing the Research Plans for the Selected Targets known as [**] and [**] (the “Development Candidate Data”). EPIZYME will transfer the Development Candidate Data for each of [**] and [**] on the timelines set forth in Appendix A, and will complete transfer of all Development Candidate Data for both [**] and [**] within [**] weeks following EPIZYME’s completion of experiments that generate Development Candidate Data for such Selected Target. Epizyme shall notify GSK in writing (which may be provided via email between Alliance Managers) when transfer of all Development Candidate Data is complete for each Selected Target (each date referred to as a “Transfer Date”). Execution Version
2.5.2 GSK will review Development Candidate Data as soon as reasonably practicable after receipt from EPIZYME, and in any event will commence such review prior to the applicable Transfer Date. The JPT shall discuss the Development Candidate Criteria as needed during GSK’s review thereof. Within [**] weeks after the Transfer Date for each Selected Target, the JPT shall meet to decide whether to recommend at least one (1) Lead Compound for each Selected Target to the JSC as a Development Candidate. If the JPT decides to recommend at least one (1) Lead Compound to the JSC, then the JSC shall meet promptly thereafter to determine whether the applicable Development Candidate Selection Criteria have been achieved with respect to such Lead Compound. Notwithstanding Sections 4.3 and 4.1.2 of the Agreement, the JPT and JSC shall not disband and shall continue to function beyond the end of the Research Term for so long as is necessary to fulfill the obligations set forth in this Amendment No. 5.
2. Within [**] days after the Amendment Effective Date, EPIZYME shall provide the following information to GSK in writing (whi...
Reports; Results. During the Research Term and the Pre-Development Term, each Party shall provide written progress reports on the status of its activities under the Research Plan (and/or, with respect to SUTRO, the Pre-Development Plan, as applicable), on a BAC/ADC Program-by-BAC/ADC Program basis, including detailed summaries of data associated with such activities, at least five (5) Business Days in advance of each JSC meeting with respect to matters that are under the purview of the JSC.
Reports; Results. Subject to Sections 2.3.6 and 2.8.2, each Party shall provide written progress reports on the status of its activities under the Research Plan during the Collaboration, on an Available Target-by-Available Target, including detailed summaries of data associated with such activities and, in the case of EPIZYME, reasonably detailed summaries of data generated in the course of its ongoing platform discovery activities to the extent not previously provided to CELGENE and relevant to the identification or attractiveness for selection of potential Available Targets under Section 2.9.3, at least [**] Business Days in advance of each JRC meeting.
Reports; Results