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:
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 the activities performed and any Results achieved or generated during its Development of the Products.
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. 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. During the term of this Agreement, Respirics shall (i) provide monthly status reports via teleconference with TEAMM regarding Respirics’ progress with respect to the Development Program and (ii) furnish written reports regarding the progress of the Development Program within thirty (30) days of the completion of each Phase of the Development Program. A final written report setting forth the results of the Development Program shall be prepared by Respirics and submitted to TEAMM within thirty (30) days following the sooner of (i) completion of the Development Program or (ii) the effective date of any early termination pursuant to Section 5. In addition, during Phases TV and V of the Development Program, Respirics shall keep TEAMM periodically informed as to the progress of the regulatory approval process with respect to the Product, and, to the extent reasonably possible, shall provide TEAMM with advance notice of any pending approval in order to provide sufficient time to prepare for the initiation of TEAMM’s marketing and sales efforts pursuant to the Distribution Agreement (as defined below).
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.
Development Reporting. Xxxxx shall provide the Joint Steering Committee no later than ten (10) Business Days prior to each scheduled Joint Steering Committee meeting, with written materials that summarize, in reasonable detail, material Development activities performed during the immediately preceding period since the last meeting of the Joint Steering Committee, and compare such performance with the goals and timelines set forth in the Development Plan. Xxxxx shall also provide the Joint Steering Committee with notice of any material delay in Development or material excess of the Budget when compared to the Development Plan promptly after Xxxxx reasonably determines that material delay or excess of the Budget is or is likely to occur.
Development Reporting. Beginning in calendar year 2019 and until the Date of First Commercial Sale, Licensee will provide XXXX with a written Development Report summarizing its development activities since the last Development Report (including the status and expected timelines for applications for regulatory approvals), and identifying any adjustments to the Development Plan Licensee believes in good faith are necessary for commercially reasonable and diligent development of Products. XXXX will consider Licensee’s proposed adjustments in good faith, and promptly inform Licensee of any comments on the Development Plan, which Licensee will consider in good faith. This Agreement will be amended to include the good faith, commercially reasonable adjustments to the Development Plan provided by Licensee, with any further adjustments that Licensee incorporates based upon XXXX’x comments, but in no case will those adjustments in the Development Plan be less favorable to the Licensee than the current terms specified in Section 3B. Moreover, and for clarity, Licensee’s adjustments to the Development Plan shall not affect the timelines for the Financial or Diligence Milestones above, nor relieve Licensee of its diligence obligation under Section 3A, unless XXXX and Licensee agree in writing to an amendment to the Financial or Diligence Milestones. Licensee will submit Development Reports on an annual basis within [***] days of December 31 of each calendar year and include sufficient detail to enable XXXX to determine Licensee’s progress toward the Development Plan and Diligence Milestones, as well as summarizing the business and activities of its sublicensee(s) including the extent to which any sublicensee has made progress toward the Development Plan and/or Diligence Milestones.
