Development Reporting. BIOSANTE undertakes to provide PERMATEC regularly, but at least twice yearly (within sixty (60) days of the start of the calendar year and July 1, respectively), with an update reasonably detailing the steps and actions performed and results achieved or gained by BIOSANTE in pursuing the Development pursuant to the Development Plan, including without limitation information on the status of any filing for Approvals for each Product.
Development Reporting. Within […***…] of […***…] during the term of this Agreement, Bayer shall provide Dimension with written progress reports through the JSC and JPT, setting forth in reasonable detail the progress of the development, evaluation, testing, and commercialization of each Licensed GT Product and Licensed Treatment. Bayer will also notify Dimension within […***…] of the First Commercial Sale by Bayer, its Affiliates, or any Sublicensees of each Licensed Treatment. Such a report (“Development Progress Report”), setting forth the current stage of development of Licensed GT Products, shall include:
7.3.1 Date of Development Progress Report and time covered by such report;
7.3.2 Major activities and accomplishments completed by Bayer, its Affiliates, and any Sublicensees relating directly to the Licensed GT Product since the last Development Progress Report;
7.3.3 Significant research and development projects relating directly to the Licensed GT Product currently being performed by Bayer, its Affiliates, and any Sublicensees and projected dates of completion;
7.3.4 Development activities anticipated for the next […***…];
7.3.5 Projected total development remaining before product launch of each Licensed Treatment; and
7.3.6 Summary of significant development efforts using the Sublicensed Technology being performed by Third Parties, including the nature of the relationship between Bayer and such Third Parties.
Development Reporting. With respect to each Calendar Year in which NVS conducts any Development activities (a) for any Candidates or any Products other than an In-Vivo [***] Product, NVS will, on or before December 30th of such Calendar Year, provide to HMI (through the JSC) for its review and discussion, [***] report summarizing (i) NVS’ and its Affiliates’ and Sublicensees’ material Development and regulatory activities with respect to each such Product over the prior Calendar Year, and (ii) any planned future Development and regulatory activities, including those activities it anticipates to initiate or have initiated for the following Calendar Year; and (b) for any In-Vivo [***] Products, NVS will, on or before May 31st and December 30th of such Calendar Year, provide to HMI (through the JSC) for its review and discussion, [***] report summarizing (i) NVS’ and its Affiliates’ and Sublicensees’ material Development and regulatory activities with respect to each In-Vivo [***] Product during the prior 6 month period; and (ii) any planned future Development and regulatory activities, including those activities it anticipates to initiate or have initiated during the following 6 month period (each of (a) and (b), a “Development Report”).
Development Reporting. XYNOMIC shall inform BII on an [****] basis on the activities performed and any Results achieved or generated during its Development of the Products.
Development Reporting. Every year within [***] days after the anniversary of the Effective Date, ProNAi shall provide a written report to Marina and the Parties shall meet by teleconference to discuss the progress and results of the development program on Licensed Products during the previous year, including a summary of results and of the efforts taken in relation to the preparation submission of applications and other filings for Regulatory Approvals for each of the Licensed Products in the Field of Use. ProNAi shall also provide prompt written notice to Marina of (i) any Regulatory Approval received for any Licensed Product in any country and (ii) the anticipated commercial launch date for the Licensed Product in each country. The information communicated in such reports, at such meetings and in such notices shall be deemed to be ProNAi’s Confidential Information.
Development Reporting. Every year within [***] after the anniversary of the Effective Date, MirnaRx shall provide to Marina Bio a written report setting out a reasonably detailed summary of progress and results of the development program on Licensed Product since the last report, including a summary of results and of the efforts taken in relation to the preparation submission of applications and other filings for Regulatory Approvals for the Licensed Product in the Field of Use. MirnaRx shall also provide prompt written notice to [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Marina Bio of (i) any Regulatory Approval received for any Licensed Product in any country and (ii) the anticipated commercial launch date for the Licensed Product in each country. The information contained in such reports and notices shall be deemed to be MirnaRx’s Confidential Information.
Development Reporting. Argent shall provide TEAMM with monthly status reports prior to the submission of the ANDAs for the Products, and quarterly status reports following the submission of the ANDAs for the Products and prior to the Approval, via teleconference with TEAMM regarding Argent’s progress with respect to the drug development required hereunder. Such status reports shall include “Xxxx Charts” to TEAMM regarding Argent’s progress and timelines with respect to the drug development required hereunder.
Development Reporting. Filings and acceptance of filings for Regulatory Approval of the Licensed Products in any Major Market in the Territory
Development Reporting. Every year within [***] after the anniversary of the Effective Date, MirnaRx shall provide to Marina Bio a written report setting out a reasonably detailed summary of progress and results of the development program on Licensed Product since the last report, including a summary of results and of the efforts taken in relation to the preparation submission of applications and other filings for Regulatory Approvals for the Licensed Product in the Field of Use. MirnaRx shall also provide prompt written notice to Marina Bio of (i) any Regulatory Approval received for any Licensed Product in any country and (ii) the anticipated commercial launch date for the Licensed Product in each country. The information contained in such reports and notices shall be deemed to be MirnaRx’s Confidential Information.
Development Reporting. No later than [***] during the Term for so long as GSK is conducting the Development, GSK will provide Surface, via the Alliance Managers pursuant to Section 6.1(f), with reasonably detailed written reports summarizing the material Development activities it has performed, or caused to be performed, since the preceding report, its material Development activities in process, and the future material Development activities it expects to initiate prior to the next report. GSK will respond to the reasonable questions or requests of the JDC or Surface, as applicable, for additional information relating to such activities in a timely manner. In addition, upon Surface’s request, no more than [***] per [***], GSK’s senior executives responsible for the Development and related Manufacturing activities with respect to the Licensed Products will meet with Surface’s senior executives to discuss GSK’s or its Affiliates’ or its or their Sublicensees’ Development and related Manufacturing activities for such Licensed Product.
