Ongoing Clinical Studies. The Termination Party will responsibly wind-down, in accordance with accepted biopharmaceutical industry norms and ethical practices, any on-going clinical studies for which it has responsibility hereunder in which patient dosing has commenced, and Amgen will be responsible for any costs and expenses reasonably associated with or actually incurred with such wind-down.
Ongoing Clinical Studies. For each Collaboration Product that is not a CoDev Product, there shall not be a period of longer than [***] year during which there is no ongoing Clinical Study being conducted by SGEN for such Collaboration Product. In the event of one or more material delays outside of SGEN’s reasonable control (e.g., for technical, including manufacturing, scientific or regulatory reasons), then such [***] year period shall be reasonably extended to account for such delay(s), provided that SGEN shall provide sufficient documentation to PIRS to substantiate the basis for the material delay(s). 86 Portions of the exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. CONFIDENTIAL TREATMENT REQUESTED
Ongoing Clinical Studies the Parties will collaborate to identify and prioritize the transfer of the working study management files for study A4991014 and such other documents and data related to such study as may not have been specifically identified in this Schedule B but the transfer of which nevertheless would facilitate a smooth transition of such trial. In addition, the Parties will meet during the first *** months following the Effective Date at the request of either Transition Coordinator, to discuss such other exchanges of information or steps as shall ensure a smooth transition of such trial.
Ongoing Clinical Studies. The Parties acknowledge and agree that (i) PEI shall be responsible for continuing to manage, and shall use Commercially Reasonable Efforts to complete, the Ongoing Clinical Studies in accordance with the Development Plan; and (ii) MERRIMACK shall bear the Development Costs associated with the conduct of the Ongoing Clinical Studies incurred after the Effective Date in accordance with Section 4.1(d).
Ongoing Clinical Studies. For each Collaboration Product that is not a CoDev Product, there shall not be a period of longer than [***] year during which there is no ongoing Clinical Study being conducted by SGEN for such Collaboration Product. In the event of one or more material delays outside of SGEN’s reasonable control (e.g., for technical, including manufacturing, scientific or regulatory reasons), then such [***] year period shall be reasonably extended to account for such delay(s), provided that SGEN shall provide sufficient documentation to PIRS to substantiate the basis for the material delay(s). [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. 66
Ongoing Clinical Studies. If Astellas is conducting (or having conducted on its behalf) any on-going clinical studies for which it has responsibility hereunder in which patient dosing has commenced, Astellas shall, subject to CytomX’s rights under Section 13.5, either (a) continue to conduct such clinical studies, or (b) responsibly wind-down, in accordance with accepted biopharmaceutical industry norms and ethical practices, and [***].
Ongoing Clinical Studies. Seres shall remain responsible for and shall complete at its sole cost all ongoing Clinical Studies as of the Effective Date in the Licensed Territory, as listed in the initial Development and Regulatory Activity Plan attached to this Agreement as Exhibit C (each, an “Ongoing Clinical Study”), including preparing all analysis and reports therefor, to support Regulatory Approval of SER-109 in the Licensed Territory for the treatment of rCDI, and shall remain responsible for contracting with and managing any Third Party independent contractor performing activities in connection with such Clinical Studies. For the sake of clarity, no costs incurred by Seres in performing its obligations under this Section 4.1(a) shall constitute Allowable Expenses.
Ongoing Clinical Studies. As of the Effective Date, EMD Serono is conducting, sponsoring and supporting the Ongoing Clinical Studies. To effect the transfer of the conduct, sponsorship and support of the Ongoing Clinical Studies to Thera, on the Closing Date, EMD Serono shall assign and delegate to Thera all of EMD Serono’s rights and obligations under those Ongoing Clinical Study Contracts which do not require the prior consent of any Third Parties and, after the Closing Date, EMD Serono shall use commercially reasonable efforts to obtain the prior consent of any Third Parties to assign and delegate to Thera all of EMD Serono’s rights and obligations under those Ongoing Clinical Study Contracts requiring such consent and Thera shall assume all such rights and obligations after the Closing Date. EMD Serono shall retain all rights and obligations relating to performance or non-performance under the Ongoing Clinical Study Contracts prior to the Closing Date. EMD Serono shall use commercially reasonable efforts to complete the assignments of the Ongoing Clinical Study Contracts requiring the prior consent of Third Parties before the Closing Date and Thera shall take any actions necessary, including the execution of any applicable instruments or agreements, to complete such assignments. After the Closing Date, EMD Serono shall have the right to terminate any of the Ongoing Clinical Study Contracts that are not assigned or transferred, and any costs associated with such termination shall be borne by Thera.
Ongoing Clinical Studies. If Santen is conducting (or having conducted on its behalf) any on-going clinical studies for which it has responsibility hereunder in which patient dosing has commenced, Santen shall, subject to Aerie’s rights under Section 13.5, either (a) transfer responsibility for such clinical studies to Aerie, or (b) responsibly wind-down, in accordance with accepted pharmaceutical industry norms and ethical practices, and in the case of (a) and (b) Santen will be responsible for any costs associated therewith.
Ongoing Clinical Studies. With respect to each IND for an Ongoing Study listed in Exhibit O, the Parties shall use commercially reasonable efforts to enter into a mutually acceptable IND Transfer Agreement to enable Xxxxxxx to assume responsibility for performing the activities set forth in Exhibit O and such activities as may be hereafter agreed by the Parties in any IND Transfer Agreement. Geron shall remain responsible in all cases for all costs and liabilities arising in connection with its performance of, or failure to perform, any activities or obligations with respect to any Ongoing Study (x) prior to the Effective Date and thereafter until IND transfer for such Ongoing Study, and (y) regardless of the date of such IND transfer as specified or assigned in Exhibit O for Geron’s performance, in both cases (x) and (y) in relation to each Ongoing Study listed on Exhibit O, unless the Parties agree otherwise in any IND Transfer Agreement. Geron shall reimburse Xxxxxxx for the Development Costs expended by Xxxxxxx in connection with its performance of the activities or obligations set forth in Exhibit O and any IND Transfer Agreement, unless such IND Transfer Agreement provides otherwise. Until such time (if any) that the Parties are able to enter into a mutually acceptable IND Transfer Agreement with respect to any such IND described in this subsection, at Geron’s request, Xxxxxxx [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. shall use commercially reasonable efforts to expend the FTE resources necessary to assist Geron (as Geron’s designee) in performing any activities specified in Exhibit O for Geron’s performance, such as by preparing Regulatory Filings for review and submission by Geron, and Geron shall (x) remain responsible for all costs and liabilities arising from acts, or any failure to act, in relation to such Geron-held INDs, and (y) shall reimburse Xxxxxxx for the Development Costs expended by Xxxxxxx in connection with its performance of such requested activities. For clarity, Exhibit O is intended to assign to the Parties their respective internal operational responsibilities hereunder (and not, e.g., allocate or transfer any liabilities or costs), and in the event of any inconsistency between the terms of Exhibit O and the body of this Agreement, the body of this Agreement shall control.
