Ongoing Clinical Trials. (i) If Jounce was conducting one or more Clinical Trials with respect to the Co-Co Candidate and/or Co-Co Product under the Collaboration that involve activities that are in excess of that which is necessary for the preparation of the applicable Data Package (each such Clinical Trial, an “Ongoing Clinical Trial”), including (a) enrollment of additional subjects to such Clinical Trial under an amendment to the protocol for such Clinical Trial, or (b) a separate Clinical Trial, and such activities, including as described in (a) or (b) have not been completed as of the Jounce Lead Effective Date, including any Core Dossier Study, then Jounce will continue to be responsible for the performance of such activities, including such Clinical Trial(s). [Unless otherwise agreed by the Parties [***](A) the Direct Costs incurred by Jounce on and after [***] such Ongoing Clinical Trial, provided such Ongoing Clinical Trial [***]Direct Costs incurred by Jounce [***]with respect to such Ongoing Clinical Trial [***] Direct Costs incurred by Jounce) [***] (the “Allocable Costs”), together with [***]. The Parties understand and agree that[***] Ongoing Clinical Trial [***]. For each Ongoing Clinical Trial that Celgene does not agree to include in the Worldwide Development Costs that are subject to the Development Cost Share, (x) Jounce may only conduct such Ongoing Clinical Trial at its sole expense, subject to adjustment pursuant to the [***] and the [***] set forth below, and (y) Celgene shall always be entitled to reference any safety data generated in any such Ongoing Clinical Trial; and 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.
Ongoing Clinical Trials. Licensee shall promptly assign to Company the management and continued performance of any clinical trials for Licensed Product ongoing hereunder as of the effective date of such termination, ***.
Ongoing Clinical Trials. ARES TRADING shall transfer to Intrexon at Intrexon’s expense the management and continued performance of all clinical trials for Terminated Products ongoing as of the effective date of such termination, unless Intrexon gives written notice that it elects not to continue any such clinical trial, in which case ARES TRADING shall be responsible for an orderly conclusion of such trial in accordance with applicable law and at its own expense.
Ongoing Clinical Trials. As soon as practicable and subject to applicable law, including GCP, AstraZeneca shall transfer to FibroGen the management and continued performance of all Clinical Trials for Products for the terminated regions ongoing as of the effective date of such termination, that are being conducted by AstraZeneca at such time.
Ongoing Clinical Trials. Subject to Section 7.6(b)(ii), unless expressly prohibited by any Regulatory Authority or applicable Laws, at vTv’s written request made within [***] days of the effective date of termination, Reneo shall, and shall cause its Affiliates and Sublicensees to, (i) wind down in accordance with Applicable Law any or all clinical studies involving Licensed Products being conducted by or on behalf of Reneo or its Affiliate or Sublicensee as of the effective date of termination, at Reneo’s cost and expense, or (ii) (x) transfer control to vTv of any or all clinical studies involving Licensed Products being conducted by or on behalf of Reneo or any of its Affiliate or Sublicensees as of the effective date of termination and (y) continue to conduct such clinical studies involving Licensed Products being conducted by or on behalf of Reneo or any Affiliate or Sublicensee as of the effective date of termination for up to [***] months to enable such transfer to be completed without interruption of any such clinical study, in each case ((ii)(x) and (ii)(y)), at vTv’s cost and expense.
Ongoing Clinical Trials. XXXXX shall continue to supply finished drug product and, upon PFIZER’s request, active pharmaceutical ingredients, for use by subjects in the [*************************] clinical trials from XXXXX’x available inventory, in each case at no cost to PFIZER, until such trials are completed. XXXXX confirms that it has set aside sufficient materials from its currently available inventory to complete such clinical trials in accordance with current projections. Notwithstanding the preceding sentence, if XXXXX’x available inventory becomes insufficient to supply such clinical trials through no fault of XXXXX, PFIZER shall supply the additional finished drug product or active pharmaceutical ingredients required to complete such trials at PFIZER’s sole expense.
Ongoing Clinical Trials. If this Agreement is terminated while any clinical trial is ongoing, Lumena shall notify Sanofi of its decision either to continue or wind down all such trials. The Parties shall negotiate in good faith and adopt a plan to wind-down the development activities in an orderly fashion (not to exceed [...***...]) or, at Sanofi’s election, promptly transition such development activities to Sanofi, with due regard for patient safety and the rights of any subjects that are participants in any clinical trials of any terminated Licensed Products, and take any actions it deems reasonably necessary or appropriate to avoid any human health or safety problems and in compliance with all applicable laws.
Ongoing Clinical Trials. (i) If Jounce was conducting one or more Clinical Trials with respect to the Co-Co Candidate and/or Co-Co Product under the Collaboration that involve activities that are in excess of that which is necessary for the preparation of the applicable Data Package solely for the Lead Program (each such Clinical Trial, an “Ongoing Clinical Trial”), including (a) enrollment of additional subjects to such Clinical Trial under an amendment to the protocol for such Clinical Trial, or (b) a separate Clinical Trial, and such Clinical Trial described in (a) or (b) has not been completed as of the Celgene Lead Effective Date, including any Core Dossier Study, then Jounce will continue to be responsible for the performance of such Clinical Trial(s); and
Ongoing Clinical Trials. If at the time Allergan provides notice of termination pursuant to Section 11.2.2 or upon UroGen’s termination pursuant to Section 11.2.1, Section 11.2.3, or Section 11.2.5, there are ongoing Clinical Trials being conducted by or on behalf of Allergan (or its Affiliate or Sublicensee), then Allergan shall terminate such Clinical Trial as permitted by Applicable Law and shall be responsible for the diligent, ethical and orderly wind-down of the Clinical Trials in accordance with Applicable Law and the instructions of any applicable Regulatory Authority. Allergan shall endeavor to complete any such termination within [*] days of the relevant notice of termination and shall provide to UroGen a final clinical study report for any such terminated Clinical Trial no later than [*] months following the date of such Clinical Trial’s termination.
Ongoing Clinical Trials. As soon as practicable after the Effective Date, the Parties shall meet and discuss at the Governance Committee, the status, as of the Effective Date, of any ongoing clinical trials with respect to the Products being sponsored and/or conducted pursuant to the terms of the Option 264813180 v3 Agreement in order to determine the manner in which such clinical trials will be completed, the responsibilities of the Parties with respect thereto (taking into account MPAG’s reasonably available personnel resources and capabilities), and the estimated MPAG Ongoing Clinical Trial Costs that would be incurred by MPAG in the event that MPAG continued to sponsor and conduct such ongoing clinical trials after the Effective Date. To the extent the Governance Committee reasonably determines that MPAG will continue after the Effective Date to sponsor any ongoing clinical trial being sponsored and/or conducted by MPAG as of the Effective Date (an “MPAG Ongoing Clinical Trial”), Novartis (i) shall be responsible for and shall reimburse MPAG after issuance of an invoice therefor, for the MPAG Ongoing Clinical Trial Costs actually incurred, (ii) shall cooperate with MPAG to transfer the sponsorship and conduct of such MPAG Ongoing Clinical Trial to Novartis or its designee as soon as reasonably practicable as determined by the Governance Committee, and (iii) shall indemnify the MPAG Indemnitees with respect to each MPAG Ongoing Clinical Trials as set forth in Section 15.2(c).
