Development Activities Reports Clause Samples
Development Activities Reports. During the Option Period for a given Collaboration Program, Voyager shall periodically provide to the DAC, at each regularly scheduled meeting thereof, but in no event less than on a Calendar Quarter basis, or more frequently as reasonably requested by the other Party or the DAC, a report regarding Development activities conducted by or on behalf of Voyager or planned to be undertaken with respect to each Collaboration Program, 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 (including a disclosure of Collaboration Technology developed or generated since the last written report) relating to each Collaboration Program. In addition, (a) in connection with each regularly scheduled meeting of the DAC during the Option Period, Voyager shall provide to the DAC and Genzyme copies of all then-available research, preclinical, clinical, regulatory and supporting data, summaries and reports and any material correspondence with Regulatory Authority with respect to any Collaboration Product, and (b) Voyager shall promptly share with Genzyme all material developments and information that it comes to possess relating to the Development of any Collaboration Products, including Safety Concerns, study reports and data generated from Clinical Studies of such Collaboration Product. Genzyme shall have the right to reasonably request clarifications and answers to questions with respect to such reports and Voyager shall provide such clarifications and answers to Genzyme in a timely manner.
Development Activities Reports. On a Regional Target-by-Regional Target basis, each Party will periodically provide to the JDC, on a [***] basis, or more frequently as reasonably requested by the JDC, an update regarding Development activities conducted by or on behalf of such Party with respect to Regional Antibody Candidates and Regional Licensed Products for such Regional Target, as well as any Supplemental Studies, Regional [***] Activities and Post-Marketing Studies conducted by or on behalf of such Party with respect to Regional Antibody Candidates and Regional Licensed Products for such Regional Target. The Parties will periodically report to the JDC, but in no event less than on a [***] basis, regarding their respective activities conducted under the RLP Development Plan for Regional Antibody Candidates and Regional Licensed Products for such Regional Target. In addition, each Party will promptly share with the other Party all material developments and information that it comes to possess relating to the Development of any Regional Antibody Candidates and Regional Licensed Products for such Regional Target, including (a) Safety Concerns for Regional Antibody Candidates or Regional Licensed Products, and (b) study reports and data generated from Clinical Studies of such Regional Antibody Candidates and Regional Licensed Products for such Regional Target; provided however, that excluding Safety Concerns or as required under the SDEA, a Party as Proposing Party will not be obligated to share any study reports and data generated from Clinical Studies for any Additional Development Activities (including Regional [***] Activities) 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. conducted by or on behalf of the Proposing Party where the Non-Proposing Party has not exercised an Additional Development Opt-in Notice other than to permit the Non-Proposing Party data to determine whether to deliver an Additional Development Opt-In Notice in accordance with Section 5.2.2.4(d).
Development Activities Reports. On a Global Target-by-Global Target basis and until the transition of Development to Novartis, each Party will periodically (a) provide to the JDC, on a [***] basis, an update regarding Development activities conducted by or on behalf of such Party with respect to Global Antibody Candidates or Global Licensed Products for such Global Target, and (b) report to the JDC, but in no event less than on a [***] basis, regarding their respective activities conducted under the Global Transition Plan for Global Antibody Candidates and Global Licensed Products for such Global Target. Following the transition period with respect to a Global Target, once per [***] Novartis will provide to Surface, through the JDC, an update regarding Development activities conducted by or on behalf of Novartis with respect to such Global Target Antibody Candidates and Global Licensed Product, as well as 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. any Clinical Studies with respect to such Global Target Antibody Candidates and Global Licensed Product conducted by Novartis. The Parties will share any Safety Concerns with respect to such Global Antibody Candidates and Global Licensed Products in accordance with the SDEA.
Development Activities Reports. Each Party shall provide and shall cause its Related Parties to provide to the JSC semi-annually, an update regarding Development activities conducted by or on behalf of such Party with respect to such Licensed Drug Candidate and Licensed Product. The Parties shall report to the JSC semi-annually, regarding their respective activities conducted under the Global Development Plan for such Licensed Drug Candidate and Licensed Product. In addition, each Party shall promptly share with the other Party all material developments and information that it comes to possess relating to the Development of any Licensed Drug Candidate and Licensed Products, including safety concerns and study reports and data generated from Clinical Studies of such Licensed Drug Candidate and Licensed Product.
Development Activities Reports. Licensee will periodically provide to the JDC, but no less than at each meeting of the JDC or more frequently as reasonably requested by the JDC, an update regarding Development activities conducted by or on behalf of Licensee or its Related Parties with respect to the Licensed Products in the Licensee Territory, as well as any Phase 4 Required Clinical Trial or Phase 4 Optional Clinical Trial conducted by or on behalf of Licensee or its Related Parties with respect to the Licensed Products in the Licensee Territory.
Development Activities Reports. On a Global Target Pair-by-Global Target Pair basis, Novartis will provide to the JDC, on a [...***...] basis, an update regarding Development activities for such Global Target Pair, including any material Research or pre-clinical Development activities or Clinical Studies conducted by Novartis. Without limiting the foregoing, on a Global Target Pair-by-Global Target Pair basis, Novartis shall provide Xencor with annual written reports within [...***...] after the end of each Calendar Year, summarizing Novartis’ and its Affiliates’ and Sublicensees’ Development efforts with respect to such Global Target Pair during such Calendar Year, including significant preclinical, clinical and regulatory events such as initiation and results of Clinical Studies and filing of significant Regulatory Materials and a description of planned activities for the following Calendar Year. In addition to such report and during such same period, at Xencor’s reasonable request, Xencor and Novartis will meet in-person or remotely by telephone or video-conference at least [...***...] in order for Novartis to update Xencor regarding the matters described in this Section 5.2.4.1.
Development Activities Reports. DS shall provide to Esperion, [***]basis through the JCC, a confidential written progress report that summarizes for each Licensed Product [***]t. In addition, DS shall translate, [***], CSRs and top-line data derived from Clinical Studies of Licensed Products as soon as practically possible into English and shall share such translated CSRs and top-line data with Esperion promptly after completion of such translation into English. Esperion shall provide to DS, [***] basis through the JCC, an update on the progress of the Pre-Approval Clinical Studies and the preparation for the Registration Dossiers in South Korea and Taiwan.
Development Activities Reports. Esperion shall provide to the JCC [***], a confidential written progress report that summarizes for each Licensed Product: [***]. In addition to the foregoing, Esperion shall promptly share with DSE all material developments and information that it comes to possess relating to the Development of any Licensed Product, including Safety Concerns and study reports and data generated from Global Clinical Studies, including but not limited to patient-level data, of any such Licensed Product.
Development Activities Reports. Each Party will periodically provide to the PJSC responsible for a Regional Licensed Product, but in no event less than on a Calendar Quarter basis, or more frequently as reasonably requested by the other Party, an update regarding Development activities conducted by or on behalf of such Party with respect to such Regional Licensed Product, as well as any Secondary Indication Studies and Post-Marketing Studies conducted by or on behalf of such Party with respect to such Regional Licensed Product. The Parties will periodically report to the PJSC responsible for a Regional Licensed Product, but in no event less than on a Calendar Quarter basis, regarding their respective activities conducted under the Global Development Plan for such Regional Licensed Product. In addition, each Party will promptly share with the other Party all material developments and information that it comes to possess relating to the Development of any Regional Licensed Products, including Safety Concerns and study reports and data generated from Clinical Studies of such Regional Licensed Product.
Development Activities Reports. On a Global Target-by-Global Target basis and until the transition of Development to Novartis, each Party will periodically (a) provide to the JDC, on a [***] basis, an update regarding Development activities conducted by or on behalf of such Party with respect to Global Antibody Candidates or Global Licensed Products for such Global Target, and (b) report to the JDC, but in no event less than on a [***] basis, regarding their respective activities conducted under the Global Transition Plan for Global Antibody Candidates and Global Licensed Products for such Global Target. Following the transition period with respect to a Global Target, once per [***] Novartis will provide to Surface, through the JDC, an update regarding Development activities conducted by or on behalf of Novartis with respect to such Global Target Antibody Candidates and Global Licensed Product, as well as any Clinical Studies with respect to such Global Target Antibody Candidates and Global Licensed Product conducted by Novartis. The Parties will share any Safety Concerns with respect to such Global Antibody Candidates and Global Licensed Products in accordance with the SDEA.