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.
Development Reports. Commencing with the beginning of 2003, COMPANY shall furnish, and shall oblige its SUBLICENSEES to furnish to COMPANY for inclusion in its reports to GI, to GI in writing, within 30 (thirty) days after the end of each calendar quarter with COMPANY's standard R&D report, as provided to the investors pursuant to the Amended and Restated Investor's Rights Agreement Series B, on the progress of its efforts during the immediately preceding calendar quarter to develop and commercialize LICENSED PRODUCTS for each indication and sub-indication within the FIELD. The report shall also contain a discussion of intended R&D efforts for the calendar quarter in which the report is submitted.
Development Reports. GlobeImmune shall provide the JRC with written development reports or presentations quarterly at JRC meetings or as otherwise agreed between the Parties. Each report or presentation shall include the Development activities relating to each Program performed by GlobeImmune since the previous JRC meeting, including a summary of results, information, and data generated, any activities planned with respect to Development going forward (including, for example, updates regarding regulatory matters and Development activities for the next Calendar Quarter), challenges anticipated and updates regarding intellectual property issues relating to each Program. Upon request by the JRC or Celgene, GlobeImmune shall provide the JRC with clinical study protocols, Statistical Analysis Plans (SAPs), investigator brochures, non-clinical protocols and reports, serious adverse events reports, data listings and tables of ongoing studies, final clinical study reports of completed studies, manufacturing information (including CMC) regulatory submissions and correspondence from Regulatory Authorities with respect to Collaboration Compounds in all regions of the Territory, and shall provide other information and such additional access to records with respect to Collaboration Compounds as the JRC or Celgene may reasonably request, including the underlying information used to create such summaries, such as case report forms (CRFs), annotated CRFs, data listings, data sets, programs used for the analyses, and imaging data (such as CT or MRI scans).
Development Reports. At each JRC meeting or as otherwise agreed between the Parties, during the Term, Celgene will provide the JRC with presentations regarding the Development activities performed by Celgene, including a summary of results, information, and data generated, and any activities planned with respect to the Development Plans going forward, including, for example, updates regarding regulatory matters, and the status of any Regulatory Approvals, in each case relating to each Celgene Development Compound. Celgene shall provide the JRC with a summary of material clinical protocols and Regulatory Filings with respect to each Celgene Development Compound.
Development Reports. From and after the date that a Licensed Product becomes Development-Ready, Gilead shall provide to Hookipa within [***] days after the end of each Calendar Year a written report which summarizes [***]. Each report shall be compiled and reported in English and shall be the Confidential Information of Gilead. If, within [***] days of Hookipa’s receipt of a written report pursuant to this Section 6.2. Hookipa provides Gilead written notice that it wishes to discuss such written report, then Gilead shall make available to Hookipa, [***].
Development Reports. At [ * ] JDC meeting, each Party shall provide the JDC with regular reports detailing its Development activities for the Products under this Agreement, and the results of such activities. In addition, after the completion of any Clinical Trial or other study of the Products, the Party responsible for the conduct of such Clinical Trial or study shall provide the other Party with a data package consisting of, at a minimum, tables, lists, and figures, as well as any other Data specified in the GDP or otherwise agreed by the Parties, within [ * ] following the completion of such data package. The Parties shall discuss the status, progress, and results of each Party’s Development activities under this Agreement at such JDC meetings.
Development Reports. The status, progress and results of Zai’s Development activities under this Agreement shall be discussed at meetings of the JDC. At least [***] Business Days before each regularly scheduled JDC meeting, Zai shall provide the JDC with a written report detailing its Product Development activities and the results thereof, covering subject matter at a level of detail reasonably requested by TPTX and sufficient to enable TPTX to determine Zai’s compliance with its obligations pursuant to Section 5.1 to Section 5.4. Through the JDC, each Party shall keep the other Party reasonably informed on the Development of the Product conducted by or on behalf of such Party. In addition, each Party shall make available to the other Party such additional information about its Development activities with Products as may be reasonably requested by the other Party from time to time. All updates and reports provided by a Party pursuant to this Section 5.5 shall be the Confidential Information of such Party.
Development Reports. Licensee shall provide Merck with reasonably detailed reports describing its progress with respect to its Development efforts under this Agreement (hereinafter “Development Reports”). Such Development Reports shall be furnished annually until the First Commercial Sale. Each Development Report shall include the following information for the Licensed Product: a description of the Development work conducted during the year in reasonable detail, including clinical studies, formulation work, manufacturing work, and other testing work and regulatory activity; timelines for such work; and key decision gates and milestones anticipated for such work. All Development Reports created by Licensee shall be deemed the Proprietary Information of Licensee and are subject to the confidentiality obligations of Article IX.
Development Reports. Xxxxxx shall keep the JSC regularly informed of the progress of its efforts to Develop Compounds in the Field and in the Territory. Without limiting the generality of the foregoing, Xxxxxx shall, at least once per Calendar Quarter, provide the JSC with reports in reasonable detail regarding the status of all pre-clinical IND-enabling studies and activities (including toxicology and pharmacokinetic studies), clinical trials and other activities conducted under each Development Plan, together with summary data and results and raw data made available if requested for each such pre-clinical IND-enabling study or activity, clinical trial and such additional information that it has in its possession as may be reasonably requested from time to time by the JSC.
Development Reports. Eiger shall provide BMS with written Development reports on or before January 31 of each Calendar Year during the term of Development activities summarizing (but without disclosing specific data or results) such activities in sufficient detail to enable BMS to determine Eiger’s compliance with its diligence obligations in Section 5.1. Such reports shall include without limitation (a) the research and other Development activities accomplished by Eiger under the existing Development Plan through the end of the immediately preceding Calendar Year with respect to Licensed Compounds and Licensed Products, and (b) updates on Eiger’s progress against the existing Development Plan; provided, however, that the first such report shall be due on or before January 31, 2017. If any such Development obligations have been sublicensed to a Sublicensee, Eiger shall require the Sublicensee to provide to BMS the same information as required of Eiger hereunder with respect to the progress of the Development of Licensed Compounds and Licensed Products by such Sublicensee. If requested by BMS, Eiger (and, if applicable, Sublicensee) personnel who prepared the report will meet with BMS (which may be by teleconference) to discuss and answer any reasonable questions or comments that BMS might have on the report and Eiger’s (and, if applicable, each of its Sublicensee’s) Development activities.
