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. During the Licensed Period, on a Licensed Product-by-Licensed Product basis, Shionogi will provide to the JSC through its representatives on the JSC in the regular meetings of the JSC, an update regarding Development activities conducted by or on behalf of Shionogi with respect to Licensed Products in the Field in the Shionogi Territory. Shionogi will report through its representatives on the JSC in the regular meetings of the JSC regarding its activities conducted under the Development Plans for Licensed Products in the Field in the Shionogi Territory. In addition, in the regular meetings of the JSC, each Party will cause its representatives to the JSC to inform the JSC of all material developments that it comes to possess relating to the Development of any Licensed Product in the Field in its respective Territory, including Safety Concerns for Licensed Products.
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.
Development Activities Reports. Each Party will periodically provide to the other Party, 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 Licensed Products for its Territory, as well as any Supplemental Studies and Post-Marketing Studies conducted by or on behalf of such Party with respect to such Licensed Products. The Parties will periodically report to each other, but in no event less than on a Calendar Quarter basis, regarding their respective activities conducted under the Development Plans or the Global Development Plan, as applicable, for Licensed Products in their respective Territory. In addition, each Party will promptly share with the other Party all material developments that it comes to possess relating to the Development of any Licensed Product in its Territory, including Safety Concerns for Licensed Products.
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.
