Common use of Ongoing Clinical Trials Clause in Contracts

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 (ii) Celgene shall determine in its sole discretion whether to include any such Ongoing Clinical Trial in the Worldwide Development Costs and subject to the Development Cost Share. If Celgene elects to include such Ongoing Clinical Trial in the Worldwide Development Costs in accordance with Section 2.3.2(a)(i), (A) the Direct Costs incurred by Jounce on and [***] for such Ongoing Clinical Trial [***] Direct Costs incurred by Jounce [***] with respect to such Ongoing Clinical Trial [***] of Direct Costs incurred by Jounce) [***] (the “Allocable Costs”), together with [***]. If Celgene does not does not agree to include any such Ongoing Clinical Trial in the Worldwide Development Costs subject to the Development Cost Share in accordance with Schedule 2.3.4, then (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. 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. (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 activities, including as described in (a) or (b) has have not been completed as of the Celgene 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); and (ii) Celgene shall determine in its sole discretion whether to include any such Ongoing Clinical Trial in . [Unless otherwise agreed by the Worldwide Development Costs and subject to the Development Cost Share. If Celgene elects to include such Ongoing Clinical Trial in the Worldwide Development Costs in accordance with Section 2.3.2(a)(i), Parties [***](A) the Direct Costs incurred by Jounce on and after [***] for such Ongoing Clinical Trial, provided such Ongoing Clinical Trial [***] ]Direct Costs incurred by Jounce [***] ]with respect to such Ongoing Clinical Trial [***] of Direct Costs incurred by Jounce) [***] (the “Allocable Costs”), together with [***]. If The Parties understand and agree that[***] Ongoing Clinical Trial [***]. For each Ongoing Clinical Trial that Celgene does not does not agree to include any such Ongoing Clinical Trial in the Worldwide Development Costs that are subject to the Development Cost Share in accordance with Schedule 2.3.4Share, then (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. (ii) Notwithstanding the foregoing, in the event that Jounce was conducting one or more Pivotal Clinical Trials with respect to any Co-Co Candidate and/or Co-Co Product that have not been completed as of the Jounce Lead Effective Date, including any Core Dossier Study, then Celgene shall determine in its sole discretion whether to include such Pivotal Clinical Trial in the Worldwide Development Costs and subject to the Development Cost Share. If Celgene elects to include such Pivotal Clinical Trial in the Worldwide Development Costs in accordance with Section 2.3.2(a)(i), then Jounce shall provide to Celgene a report of actual Development costs incurred by Jounce for such Pivotal Clinical Trial prior to Celgene’s opt-in to this Jounce Lead Co-Co Agreement, together with reasonable supporting evidence of such incurred Development costs. If Celgene does not does not agree to include any such Pivotal Clinical Trial in the Worldwide Development Costs subject to the Development Cost Share in accordance with Schedule 2.3.4, then (x) Jounce may only conduct such Pivotal 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 Pivotal Clinical Trial.](1)

Ongoing Clinical Trials. (iIf any Clinical Trial(s) If Jounce was conducting one that were being conducted by or more Clinical Trials with respect on behalf of Prothena under the Licensed Program pursuant to the Co-Co Candidate and/or Co-Co Product under the Master Collaboration that involve activities that are in excess of that which is necessary for the preparation Agreement have not been completed as of the applicable Data Package solely for the Lead Program Effective Date (each such Clinical Trial, an “Ongoing Clinical Trial”), including (a) enrollment of additional subjects to then, at Celgene’s written election, Prothena will, at its expense, either wind-down and terminate such Ongoing Clinical Trial under an amendment or continue to the protocol for perform such Ongoing Clinical Trial, or (b) a separate Clinical Trial, and such . In the event Celgene elects that an Ongoing Clinical Trial described in (a) or (b) has not been completed as of should be wound-down and terminated, Prothena shall cause such Ongoing Clinical Trial to be wound-down and terminated promptly. In the event that Celgene Lead Effective Date, including any Core Dossier Studyelects the Ongoing Clinical Trial to continue, then Jounce will Prothena shall continue to be responsible for the performance of such Clinical Trial(s); and (ii) Celgene of, and shall determine in its sole discretion whether continue to include any perform, such Ongoing Clinical Trial in accordance with (i) the Worldwide Development Costs and subject to Research Plan (as defined in the Development Cost Share. If Celgene elects to include such Ongoing Master Collaboration Agreement) as in existence as of the Effective Date, (ii) the terms of the applicable Clinical Trial protocol as in existence as of the Worldwide Development Costs Effective Date (as may be amended as required by Applicable Law and applicable guidance issued from time to time by the by the relevant Regulatory Authority) and (iii) otherwise in accordance with Section 2.3.2(a)(i)the reasonable directions of Celgene, (A) until completion of such Clinical Trial. In such case, the Direct Costs incurred by Jounce on and [***] for performance of such Ongoing Clinical Trial [***] Direct Costs incurred by Jounce [***] or on behalf of Prothena shall continue to be governed by the terms and conditions of the Master Collaboration Agreement as if the Licensed Program were continuing under the Master Collaboration Agreement solely with respect to such Ongoing Clinical Trial [***] Trial, mutatis mutandis (including that Know-How conceived, created, discovered, first generated, invented, first made or first reduced to practice, by or on behalf of Direct Costs incurred by Jounce) [***] (Prothena or its Affiliates, whether solely or jointly with any Third Party, pursuant to the “Allocable Costs”), together with [***]. If Celgene does not does not agree to include any conduct of such Ongoing Clinical Trial in Trial, shall be Licensed Program Know-How hereunder); provided that, notwithstanding the Worldwide Development Costs subject provisions of the Master Collaboration Agreement, Celgene shall have the right to make decisions and determinations with respect to the Development Cost Share in accordance with Schedule 2.3.4, then (x) Jounce may only conduct of such Ongoing Clinical Trial at its sole expense, subject to adjustment pursuant to the [***] and the [***] set forth belowTrial, and (y) Prothena shall comply with all such reasonable decisions and determinations, provided that Celgene consults with and reasonably considers Prothena’s comments with respect thereto prior to making any such decision or determination. In addition, Celgene shall always be entitled have the right, at any time, to reference any safety data generated notify Prothena to cease performance of an Ongoing Clinical Trial, and in such case, Prothena shall immediately wind-down any such Ongoing Clinical Trial. 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. (iIf any Clinical Trial(s) If Jounce was conducting one that were being conducted by or more Clinical Trials with respect on behalf of Prothena under the Licensed Program pursuant to the Co-Co Candidate and/or Co-Co Product under the Master Collaboration that involve activities that are in excess of that which is necessary for the preparation Agreement have not been completed as of the applicable Data Package solely for the Lead Program Effective Date (each such Clinical Trial, an “Ongoing Clinical Trial”), including (a) enrollment of additional subjects to then, at Celgene’s written election, Prothena will, at its expense, either wind-down and terminate such Ongoing Clinical Trial under an amendment or continue to the protocol for perform such Ongoing Clinical Trial, or (b) a separate Clinical Trial, and such . In the event Celgene elects that an Ongoing Clinical Trial described in (a) or (b) has not been completed as of should be wound-down and terminated, Prothena shall cause such Ongoing Clinical Trial to be wound-down and terminated promptly. In the event that Celgene Lead Effective Date, including any Core Dossier Studyelects the Ongoing Clinical Trial to continue, then Jounce will Prothena shall continue to be responsible for the performance of of, and shall continue to perform, such Clinical Trial(s); and CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (iiI) Celgene shall determine in its sole discretion whether to include any such NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. Ongoing Clinical Trial in accordance with (i) the Worldwide Development Costs and subject to Research Plan (as defined in the Development Cost Share. If Celgene elects to include such Ongoing Master Collaboration Agreement) as in existence as of the Effective Date, (ii) the terms of the applicable Clinical Trial protocol as in existence as of the Worldwide Development Costs Effective Date (as may be amended as required by Applicable Law and applicable guidance issued from time to time by the by the relevant Regulatory Authority) and (iii) otherwise in accordance with Section 2.3.2(a)(i)the reasonable directions of Celgene, (A) until completion of such Clinical Trial. In such case, the Direct Costs incurred by Jounce on and [***] for performance of such Ongoing Clinical Trial [***] Direct Costs incurred by Jounce [***] or on behalf of Prothena shall continue to be governed by the terms and conditions of the Master Collaboration Agreement as if the Licensed Program were continuing under the Master Collaboration Agreement solely with respect to such Ongoing Clinical Trial [***] Trial, mutatis mutandis (including that Know-How conceived, created, discovered, first generated, invented, first made or first reduced to practice, by or on behalf of Direct Costs incurred by Jounce) [***] (Prothena or its Affiliates, whether solely or jointly with any Third Party, pursuant to the “Allocable Costs”), together with [***]. If Celgene does not does not agree to include any conduct of such Ongoing Clinical Trial in Trial, shall be Licensed Program Know-How hereunder); provided that, notwithstanding the Worldwide Development Costs subject provisions of the Master Collaboration Agreement, Celgene shall have the right to make decisions and determinations with respect to the Development Cost Share in accordance with Schedule 2.3.4, then (x) Jounce may only conduct of such Ongoing Clinical Trial at its sole expense, subject to adjustment pursuant to the [***] and the [***] set forth belowTrial, and (y) Prothena shall comply with all such reasonable decisions and determinations, provided that Celgene consults with and reasonably considers Prothena’s comments with respect thereto prior to making any such decision or determination. In addition, Celgene shall always be entitled have the right, at any time, to reference any safety data generated notify Prothena to cease performance of an Ongoing Clinical Trial, and in such case, Prothena shall immediately wind-down any such Ongoing Clinical Trial. 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.