Common use of New Clinical Trials and Other Studies Clause in Contracts

New Clinical Trials and Other Studies. If, following the Jounce Lead Effective Date, a Party (the “Proposing Party”) wishes (i) to conduct a Clinical Trial or other study of Co-Co Products for ROW Administration (where the Proposing Party is Celgene), or for U.S. Administration (where the Proposing Party is Jounce), (ii) to Develop Co-Co Products in a country for which it is the Development Lead Party for any Co-Co Indication in the Field other than a Co-Co Indication for which such Co-Co Products are being Developed pursuant to the Jounce Co-Co Development Plan, (iii) to Develop a dosage form or formulation of Co-Co Products in a country for which the Proposing Party is the Development Lead Party other than that being studied in the Jounce Co-Co Development Plan, or (iv) to conduct any other Clinical Trial of a Co-Co Product in the Field in a country for which the Proposing Party is the Development Lead Party, including any Clinical Trial that the JSC determines is a Core Dossier Study after the Jounce Lead Effective Date, or any Clinical Trial or study that is not otherwise set forth in the Jounce Co-Co Development Plan, or any Clinical Trial that the Proposing Party believes may have utility to support Regulatory Approval on a global basis (each such study not already included in a Jounce Co-Co Development Plan, a “Jounce Co-Co Additional Study”), then (A) the Proposing Party shall first provide the proposed trial design and protocol for such Jounce Co-Co Additional Study to the JSC for review and approval as to the clinical and regulatory aspects of such Jounce Co-Co Additional Study, and shall incorporate reasonable comments from the JSC into such Jounce Co-Co Additional Study design and protocol, and (B) following such review by the JSC, provide the final proposed design and projected costs of such Jounce Co-Co Additional Study to the JSC.

New Clinical Trials and Other Studies. If, following the Jounce Lead Effective Date, If (i) a Party (the “Proposing Party”) wishes (i) to conduct a Clinical Trial or other study of Co-Co Products for ROW Administration (where the Proposing Party is Celgene), or for U.S. Administration (where the Proposing Party is Jounce), (iiA) to Develop Co-Co Licensed Products in a country for which it is the Development Lead Party for any Co-Co Indication in the Field other than a Co-Co the Indication for which such Co-Co Licensed [***] 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 omitted portions. Products are being Developed pursuant to the Jounce Co-Co License Development Plan, (iiiB) to Develop a dosage form or formulation of Co-Co Licensed Products in a country for which the Proposing Party is the Development Lead Party other than that being studied in the Jounce Co-Co License Development Plan, or (ivC) to conduct any other Clinical Trial of a Co-Co Product Licensed Products in the Field in a country for which the Proposing Party is the Development Lead Party, including any Clinical Trial Party that the JSC determines is a Core Dossier Study after the Jounce Lead Effective Date, not at such time [***] or any Clinical Trial or study that is not otherwise set forth in the Jounce Co-Co License Development Plan, or including any Clinical Trial that the Proposing Party believes may have utility to support Regulatory Approval on a global basis and any Phase 4 Clinical Trial (each such study not already included in a Jounce Co-Co License Development Plan, a an “Jounce Co-Co Additional Study”), then (A) the Proposing Party shall first provide may so notify the proposed trial design other Party and protocol for such Jounce Co-Co Additional Study to present the JSC for review and approval as to the clinical and regulatory aspects of such Jounce Co-Co Additional Study, and shall incorporate reasonable comments from the JSC into such Jounce Co-Co Additional Study design and protocol, and (B) following such review by the JSC, provide the final proposed design and projected costs of such Jounce Co-Co Additional Study to the JSCJRDC, and the following shall apply: (1) If the other Party (the “Non-Proposing Party”), through its members of the JRDC, agrees to conduct such co-Development and co-fund such Additional Study, the Parties would amend the License Development Plan to include such Additional Study and to provide a budget for the associated costs. The Parties shall negotiate in good faith to agree upon a [***] such Additional Study between the Parties during the [***] period following the date upon which the Non-Proposing Party agrees [***] such Additional Study, provided that if [***] within such time period, each Party shall [***]. If the Parties agree to [***] any Additional Study, [***]. (2) If the Non-Proposing Party does not wish to [***] such proposed Additional Study, but the Non-Proposing Party has no material objection to such Additional Study as set forth in Section 2.2.6(c)(3), then the Proposing Party may proceed with such Additional Study and would be solely responsible for the [***]. In such case, the Non-Proposing Party [***], unless and until a [***]; (3) Notwithstanding subsections (1) and (2), if the Non-Proposing Party believes a proposed Additional Study would be likely to [***], such Non-Proposing Party would have the right to refer such matter to the JRDC and, as needed, the JRDC and JSC (if applicable) shall review such Non-Proposing Party’s concerns and consider mechanisms to mitigate or obviate any such concerns. If the JRDC or, if applicable, the JSC does not agree upon whether or not a proposed Additional Study would have [***], then [***] for such Program [***] such matter.

New Clinical Trials and Other Studies. If, following the Jounce Lead Effective Date, If (i) a Party (the “Proposing Party”) wishes (i) to conduct a Clinical Trial or other study of Co-Co Products for ROW Administration (where the Proposing Party is Celgene), or for U.S. Administration (where the Proposing Party is Jounce), (iiA) to Develop Co-Co Licensed Products in a country for which it is the Development Lead Party for any Co-Co Indication in the Field other than a Co-Co the Indication for which such Co-Co Licensed Products are being Developed pursuant to the Jounce Co-Co License Development Plan, (iiiB) to Develop a dosage form or formulation of Co-Co Licensed Products in a country for which the Proposing Party is the Development Lead Party other than that being studied in the Jounce Co-Co License Development Plan, or (ivC) to conduct any other Clinical Trial of a Co-Co Product Licensed Products in the Field in a country for which the Proposing Party is the Development Lead Party, including any Clinical Trial Party that the JSC determines is a Core Dossier Study after the Jounce Lead Effective Date, not at such time [***] or any Clinical Trial or study that is not otherwise set forth in the Jounce Co-Co License Development Plan, or including any Clinical Trial that the Proposing Party believes may have utility to support Regulatory Approval on a global basis and any Phase 4 Clinical Trial (each such study not already included in a Jounce Co-Co License Development Plan, a an “Jounce Co-Co Additional Study”), then (A) the Proposing Party shall first provide may so notify the proposed trial design other Party and protocol for such Jounce Co-Co Additional Study to present the JSC for review and approval as to the clinical and regulatory aspects of such Jounce Co-Co Additional Study, and shall incorporate reasonable comments from the JSC into such Jounce Co-Co Additional Study design and protocol, and (B) following such review by the JSC, provide the final proposed design and projected costs of such Jounce Co-Co Additional Study to the JSCJRDC, and the following shall apply: (1) If the other Party (the “Non-Proposing Party”), through its members of the JRDC, agrees to conduct such co-Development and co-fund such Additional Study, the Parties would amend the License Development Plan to include such Additional Study and to provide a budget for the associated costs. The Parties shall negotiate in good faith to agree upon a [***] such Additional Study between the Parties during the [***] period following the date upon which the Non-Proposing Party agrees [***] such Additional Study, provided that if [***] within such time period, each Party shall [***]. If the Parties agree to [***] any Additional Study, [***]. (2) If the Non-Proposing Party does not wish to [***] such proposed Additional Study, but the Non-Proposing Party has no material objection to such Additional Study as set forth in Section 2.2.6(c)(3), then the Proposing Party may proceed with such Additional Study and would be solely responsible for the [***]. In such case, the Non-Proposing Party [***], unless and until a [***]; (3) Notwithstanding subsections (1) and (2), if the Non-Proposing Party believes a proposed Additional Study would be likely to [***], such Non-Proposing Party would have the right to refer such matter to the JRDC and, as needed, the JRDC and JSC (if applicable) shall review such Non-Proposing Party’s concerns and consider mechanisms to mitigate or obviate any such concerns. If the JRDC or, if applicable, the JSC does not agree upon whether or not a proposed Additional Study would have [***], then [***] for such Program [***] such matter.

New Clinical Trials and Other Studies. If, following the Jounce Juno Lead Co-Co Agreement Effective Date, a Party (the “Proposing Party”) wishes (i) to conduct a Clinical Trial or other study of Juno Program Co-Co Products for ROW Celgene Territory Administration (where the Proposing Party is Celgene), or for U.S. Juno Territory Administration (where the Proposing Party is JounceJuno), (ii) to Develop Juno Program Co-Co Products in a country for which it is the Development Lead Party for any Co-Co Indication in the Field other than a Co-Co an Indication for which such Juno Program Co-Co Products are being Developed pursuant to the Jounce Co-Co Development Plan, (iii) to Develop a dosage form or formulation of Juno Program Co-Co Products in a country for which the Proposing Party is the Development Lead Party other than that being studied in the Jounce Juno Co-Co Development Plan, or (iv) to conduct any other Clinical Trial of a Juno Program Co-Co Product in the Field in a country for which the Proposing Party is the Development Lead Party, including any Clinical Trial that the JSC JRDC determines is a Core Dossier Study after the Jounce Lead Effective Date[***], or any Clinical Trial or study that is not otherwise set forth in the Jounce Juno Co-Co Development Plan, or any Clinical Trial that the Proposing Party believes may have utility to support Regulatory Approval on a global basis and any Phase 4 Clinical Trial (each such study not already included in a Jounce Juno Co-Co Development Plan, a “Jounce Juno Co-Co Additional Study”), then (A) the Proposing Party shall first provide the proposed trial design and protocol for such Jounce Juno Co-Co Additional Study to the JSC JRDC for review and approval [***] as to the clinical and regulatory aspects [***] of such Jounce Juno Co-Co Additional Study, and shall incorporate reasonable comments from the JSC into such Jounce Co-Co Additional Study design and protocol[***], and (B) following such review by the JSC[***], provide the final proposed design and projected costs of such Jounce Juno Co-Co Additional Study to the JSCJRDC. In any such case the following shall apply: (1) If the other Party (the “Non-Proposing Party”), through its members of the JRDC, agrees [***] such Juno Co-Co Additional Study, the Parties shall amend the Juno Co-Co Development Plan and the Juno Co-Co Development Budget to include such Juno Co-Co Additional Study, and 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 omitted portions. (2) If the Non-Proposing Party does not wish to [***] such proposed Juno Co-Co Additional Study [***], but the Non-Proposing Party has no material objection to such Juno Co-Co Additional Study, and Section 2.2.5(b)(4) does not apply, the Proposing Party may proceed with such Juno Co-Co Additional Study and would be solely responsible for [***]. In such case, the Non-Proposing Party [***], unless and until [***]. (3) For any Juno Co-Co Additional Study that the Non-Proposing Party does not wish to [***], [***], or to [***] of such Juno Program Co-Co Product for the Indication, formulation, dosage form or other attribute of such Juno Program Co-Co Product that was the subject of such Juno Co-Co Additional Study, if the data from such Juno Co-Co Additional Study is [***] then upon such [***], such Non-Proposing Party shall be deemed to have [***], and shall make the [***], with respect to such Juno Co-Co Additional Study. Notwithstanding the foregoing, the following mechanism shall apply [***]: Upon [***], the Non-Proposing Party shall [***], at the Non-Proposing Party’s option, either (x) [***], or (y) [***]. If upon [***] to the Proposing Party for [***] for such Juno Co-Co Additional Study [***], then the remainder [***] shall be [***], provided that in no event shall [***], with any [***] to the Non-Proposing Party [***], always subject to [***]. (4) Notwithstanding subsections (1) and (2), if the Non-Proposing Party believes a proposed Juno Co-Co Additional Study [***], such Non-Proposing Party would have the right to refer such matter to the JRDC and, as needed, the JRDC and JSC (if applicable) shall review such Non-Proposing Party’s concerns and consider mechanisms to mitigate or obviate any such concerns. If the JRDC or, if applicable, the JSC does not agree upon whether or not a proposed Juno Co-Co Additional Study would have [***], then [***] for such Program [***] such matter. (5) If the Non-Proposing Party elects to [***] a Juno Co-Co Additional Study, or elects to [***] pursuant to Section 2.2.6, or is subject to a [***], as set forth in this Section 2.2.5, then following such Non-Proposing Party’s decision to [***], as applicable, [***] (including any Juno Program Co-Co Product Data) would be available for use by (A) [***] in connection with Juno Program Co-Co Products in the Field in the [***] and for [***] Territory Administration, (B) [***] in the [***] Territory and for [***] Territory Administration, and (C) by [***] in the Territory to [***] set forth in this Juno Lead Co-Co Agreement.

New Clinical Trials and Other Studies. If, following the Jounce Celgene Lead Co-Co Agreement Effective Date, a Party (the “Proposing Party”) Celgene wishes (i) to propose to conduct a Clinical Trial or other study of Celgene Program Co-Co Products for ROW Administration (where in the Proposing Party is Celgene), or for U.S. Administration (where the Proposing Party is Jounce)Territory, (ii) to propose to Develop Celgene Program Co-Co Products in a country for which it is the Development Lead Party North America Territory and/or the ROW Territory for any Co-Co Indication in the Field other than a Co-Co an Indication for which such Celgene Program Co-Co Products are being Developed pursuant to the Jounce Celgene Co-Co Development Plan, (iii) to propose to Develop a dosage form or formulation of Celgene Program Co-Co Products in a country for which the Proposing Party is North America Territory and/or the Development Lead Party ROW Territory other than that being studied in the Jounce Celgene Co-Co Development Plan, or (iv) to propose to conduct any other Clinical Trial of a Celgene Program Co-Co Product in the Field in a country for which the Proposing Party is the Development Lead PartyField, including any Clinical Trial that the JSC JRDC determines is a Core Dossier Study after the Jounce Lead Effective Date[***], or any Clinical Trial or study that is not otherwise set forth in the Jounce Celgene Co-Co Development Plan, or including any Clinical Trial that the Proposing Party Celgene believes may have utility to support Regulatory Approval on a global basis and any Phase 4 Clinical Trial (each such study not already included in a Jounce Celgene Co-Co Development Plan, a “Jounce Celgene Co-Co Additional Study”), then (A) the Proposing Party Celgene shall first provide the proposed trial design and protocol for such Jounce Celgene Co-Co Additional Study to the JSC for review and approval JRDC [***] as to the clinical and regulatory aspects [***] of such Jounce Celgene Co-Co Additional Study, and shall incorporate reasonable comments from the JSC into such Jounce Co-Co Additional Study design and protocol[***], and (B) following such review by the JSCJRDC, Celgene shall provide the final proposed design and projected costs of such Jounce Celgene Co-Co Additional Study to the JSCJRDC, and (C) the following shall apply: (1) If Juno, through its members of the JRDC, agrees that such Celgene Co-Co Additional Study should be conducted, the Parties shall amend the Celgene Co-Co Development Plan and the Celgene Co-Co Development Budget to include such Celgene Co-Co Additional Study, and the [***] such Celgene Co-Co Additional Study shall be an Allowable Expense and shall be subject to the Profit & Loss Share pursuant to Section 5.2 and Exhibit D. (2) If the Parties disagree on whether [***] such Celgene Co-Co Additional Study, then, subject to subsection (3), [***] shall have the final decision making right on whether the Parties will conduct such Celgene Co-Co Additional Study, subject to Section 2.2.5(b)(3). [***] 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 omitted portions. (3) If [***] does not [***], then Celgene may proceed with such Celgene Co-Co Additional Study and would be solely responsible for the [***]). (4) For any Celgene Co-Co Additional Study conducted that Juno does not wish to [***], or to [***] of such Celgene Program Co-Co Product for the Indication, formulation, dosage form or other attribute of such Celgene Program Co-Co Product that was the subject of such Celgene Co-Co Additional Study, if the data from such Celgene Co-Co Additional Study is [***], then upon such [***], Juno shall be deemed to have [***], and shall make the [***], with respect to such Celgene Co-Co Additional Study. Notwithstanding the foregoing, the following mechanism shall apply [***]: Upon [***], Juno shall [***], at Juno’s option, either (x) [***], or (y) [***]. If upon [***] to Celgene for a [***] for such Celgene Co-Co Additional Study is [***], then the remainder [***] shall be [***], provided that in no event shall [***], with any [***] to Juno to [***], always subject to [***]. (5) If Juno elects to [***] a Celgene Co-Co Additional Study, or elects to [***], or is subject to a [***] as set forth in this Section 2.2.5, then following Juno’s decision to [***], as applicable, all data resulting from such Celgene Co-Co Additional Study (including any Celgene Program Co-Co Product Data) would be available for use by each Party in connection with Celgene Program Co-Co Products in the Field in the North America Territory and the ROW Territory for the purpose of performing activities in accordance with the Celgene Co-Co Development Plan or otherwise as set forth in this Celgene Lead Co-Co Agreement.