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 (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.

Appears in 2 contracts

Samples: Master Research and Collaboration Agreement (Jounce Therapeutics, Inc.), Master Research and Collaboration Agreement (Jounce Therapeutics, Inc.)

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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 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. In the event Celgene elects that an Ongoing Clinical Trial should be wound-down and terminated, or (b) a separate Prothena shall cause such Ongoing Clinical Trial, Trial to be wound-down and such activities, including as described in (a) or (b) have not been completed as of terminated promptly. In the Jounce Lead Effective Date, including any Core Dossier Studyevent that Celgene elects 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 activitiesCERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, including such Clinical Trial(s). [Unless otherwise agreed by the Parties MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (AI) the Direct Costs incurred by Jounce on and after [***] such Ongoing Clinical Trial, provided such NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. Ongoing Clinical Trial [***]Direct Costs incurred in accordance with (i) the Research Plan (as defined in the 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 Effective Date (as may be amended as required by Jounce [***]Applicable Law and applicable guidance issued from time to time by the by the relevant Regulatory Authority) and (iii) otherwise in accordance with the reasonable directions of Celgene, until completion of such Clinical Trial. In such case, the performance of such Clinical Trial by 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 [***] Direct Costs incurred Trial, mutatis mutandis (including that Know-How conceived, created, discovered, first generated, invented, first made or first reduced to practice, by Jounce) [***] (the “Allocable Costs”)or on behalf of Prothena or its Affiliates, together whether solely or jointly 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 any Third Party, pursuant to the Development Cost Share, (x) Jounce may only conduct of such Ongoing Clinical Trial at its sole expenseTrial, subject shall be Licensed Program Know-How hereunder); provided that, notwithstanding the provisions of the Master Collaboration Agreement, Celgene shall have the right to adjustment pursuant make decisions and determinations with respect to the [***] and the [***] set forth belowconduct of such Ongoing Clinical Trial, 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; 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.

Appears in 1 contract

Samples: Global License Agreement (Prothena Corp Public LTD Co)

Ongoing Clinical Trials. Unless expressly prohibited by any Regulatory Authority, at Genelux’s written request, Newsoara shall and hereby does, and shall cause its Affiliates and its and their Sublicensees to, (i) If Jounce was conducting one transfer control to Genelux of any or more Clinical Trials with respect to all clinical studies involving the Co-Co Candidate and/or Co-Co Licensed Product under the Collaboration that involve activities that are in excess being conducted by or on behalf of that which is necessary for the preparation of the applicable Data Package (each such Clinical TrialNewsoara, an “Ongoing Clinical Trial”), including (a) enrollment of additional subjects to such Clinical Trial under an amendment to the protocol for such Clinical Trial, Affiliate or (b) a separate Clinical Trial, and such activities, including as described in (a) or (b) have not been completed Sublicensee as of the Jounce Lead Effective Dateeffective date of termination, including any Core Dossier Studyand (ii) continue to conduct such clinical studies, at Genelux’s cost (except that if the Agreement is terminated before the completion of the NSCLC Multi-Center Trial and the termination of the Agreement is not due to Genelux’s uncured material breach or bankruptcy, then Jounce will continue to be Newsoara shall remain responsible for the performance cost 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 NSCLC Multi-Center Trial [***]Direct Costs incurred by Jounce [***]with respect to such Ongoing Clinical Trial [***] Direct Costs incurred by Jounce) for [***] (the “Allocable Costs”), together with [***]. The Parties understand ) months after the effective date of Termination), for as long as necessary to enable such transfer to be completed without interruption of any such clinical study; provided that with respect to each clinical study for which such transfer is expressly prohibited by the applicable Regulatory Authority, if any, Newsoara or the relevant Affiliate or Sublicensee shall, at Genelux’s written request, continue to conduct such clinical study to completion, at Genelux’s cost and agree thatexpense (except that if the Agreement is terminated before the completion of the NSCLC Multi-Center Trial and the termination is not due to Genelux’s uncured material breach or bankruptcy, then Newsoara shall remain responsible for the cost of the NSCLC Multi-Center Trial for [***] Ongoing Clinical Trial ([***]) months after the effective date of Termination). Genelux shall have no obligation to request the transfer or continuation of any clinical study. For each Ongoing Clinical Trial any clinical study that Celgene Genelux does not agree to include request transfer or continuation, Newsoara shall (shall cause its Affiliates and its and their Sublicensees to) orderly wind down, or complete (if required by Applicable Laws), such clinical study in the Worldwide Development Costs that are subject to the Development Cost Share, (x) Jounce may only conduct such Ongoing Clinical Trial compliance with all Applicable Laws and at its sole Newsoara’s own cost and expense, subject to adjustment pursuant to the [***] and the [***] set forth belowexcept that if this Agreement is terminated by Newsoara in accordance with Section 10.2.1 (Termination for Material Breach), and or 10.2.3 (y) Celgene Termination for Insolvency), Genelux shall always be entitled to reference any safety data generated in any bear all costs for 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 AMENDEDactivity.

Appears in 1 contract

Samples: License Agreement (Genelux Corp)

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 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. In the event Celgene elects that an Ongoing Clinical Trial should be wound-down and terminated, or (b) a separate Prothena shall cause such Ongoing Clinical Trial, Trial to be wound-down and such activities, including as described in (a) or (b) have not been completed as of terminated promptly. In the Jounce Lead Effective Date, including any Core Dossier Studyevent that Celgene elects the Ongoing Clinical Trial to continue, then Jounce will Prothena shall continue to be responsible for the performance of such activitiesof, including such Clinical Trial(s). [Unless otherwise agreed by the Parties [***](A) the Direct Costs incurred by Jounce on and after [***] such Ongoing Clinical Trialshall continue to perform, provided such Ongoing Clinical Trial [***]Direct Costs incurred in accordance with (i) the Research Plan (as defined in the 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 Effective Date (as may be amended as required by Jounce [***]Applicable Law and applicable guidance issued from time to time by the by the relevant Regulatory Authority) and (iii) otherwise in accordance with the reasonable directions of Celgene, until completion of such Clinical Trial. In such case, the performance of such Clinical Trial by 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 [***] Direct Costs incurred Trial, mutatis mutandis (including that Know-How conceived, created, discovered, first generated, invented, first made or first reduced to practice, by Jounce) [***] (the “Allocable Costs”)or on behalf of Prothena or its Affiliates, together whether solely or jointly 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 any Third Party, pursuant to the Development Cost Share, (x) Jounce may only conduct of such Ongoing Clinical Trial at its sole expenseTrial, subject shall be Licensed Program Know-How hereunder); provided that, notwithstanding the provisions of the Master Collaboration Agreement, Celgene shall have the right to adjustment pursuant make decisions and determinations with respect to the [***] and the [***] set forth belowconduct of such Ongoing Clinical Trial, 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; 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.

Appears in 1 contract

Samples: Master Collaboration Agreement (Prothena Corp PLC)

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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 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 perform such Ongoing Clinical Trial. In the [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the protocol for omitted portions. event Celgene elects that an Ongoing Clinical Trial should be wound-down and terminated, Prothena shall cause such Ongoing Clinical Trial, or (b) a separate Trial to be wound-down and terminated promptly. In the event that Celgene elects the Ongoing 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 StudyTrial to continue, then Jounce will Prothena shall continue to be responsible for the performance of such activitiesof, including such Clinical Trial(s). [Unless otherwise agreed by the Parties [***](A) the Direct Costs incurred by Jounce on and after [***] such Ongoing Clinical Trialshall continue to perform, provided such Ongoing Clinical Trial [***]Direct Costs incurred in accordance with (i) the Research Plan (as defined in the 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 Effective Date (as may be amended as required by Jounce [***]Applicable Law and applicable guidance issued from time to time by the by the relevant Regulatory Authority) and (iii) otherwise in accordance with the reasonable directions of Celgene, until completion of such Clinical Trial. In such case, the performance of such Clinical Trial by 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 [***] Direct Costs incurred Trial, mutatis mutandis (including that Know-How conceived, created, discovered, first generated, invented, first made or first reduced to practice, by Jounce) [***] (the “Allocable Costs”)or on behalf of Prothena or its Affiliates, together whether solely or jointly 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 any Third Party, pursuant to the Development Cost Share, (x) Jounce may only conduct of such Ongoing Clinical Trial at its sole expenseTrial, subject shall be Licensed Program Know-How hereunder); provided that, notwithstanding the provisions of the Master Collaboration Agreement, Celgene shall have the right to adjustment pursuant make decisions and determinations with respect to the [***] and the [***] set forth belowconduct of such Ongoing Clinical Trial, 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; 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.

Appears in 1 contract

Samples: Master Collaboration Agreement (Prothena Corp PLC)

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