Common use of Licensee Participation Clause in Contracts

Licensee Participation. (a) If Zenas wishes to perform a Global Study that includes clinical sites in the Territory, Zenas shall prepare and provide to the JSC (i) a Development Plan relating to such Global Study and (ii) in the case of a Global Registrational Trial, a Post-Study Drug Access Plan for the Territory. Licensee shall have [***] (the “Election Period”) to elect to participate in such Global Study and, upon such election, such Global Study shall be deemed a “Joint Global Study”, and the JSC shall review and approve the Development Plan for such Joint Global Study (such Development Plan being a “Joint Development Plan”) and a budget for such Joint Global Study (a “Joint Development Plan Budget”). Within [***] of the Effective Date, the Parties will mutually agree on a Post-Study Drug Access Plan for the Territory that is consistent with Licensee’s then applicable standard operating procedures (“SOPs”) for patients in Clinical Studies to access study drugs following the conclusion of such Clinical Studies, which SOPs would be provided to Zenas at Zenas’s request through the JSC, and any costs associated with the implementation of such Post-Study Drug Access Plan for the Territory would be paid by Licensee. [***]. (b) If Licensee declines to participate in a Global Study that is a Global Registrational Trial and Licensee has determined that the conduct of such Global Registrational Trial using clinical sites in the Territory violates Applicable Laws or internationally accepted guidance (such as Declaration of Helsinki or ICH GCP principles) in the jurisdictions in the Territory in which such clinical sites will be located (a “Local Law Issue”), Licensee shall notify Zenas in writing of such determination prior to the expiration of the Election Period, which written notice shall include details supporting Licensee’s determination that there is a Local Law Issue. If Licensee does not provide written notice of a Local Law Issue prior to the expiration of the Election Period, then no Local Law Issue will be deemed to exist for purposes of Section 4.4.2(c). The Parties shall promptly meet to discuss any Local Law Issue alleged by Licensee and any potential solutions relating thereto. If the Parties are unable to agree, within a [***] period after Zenas receives Licensee’s written notice of a Local Law Issue, (A) that a Local Law Issue exists, or (B) on a potential solution that will permit Zenas to proceed with such Global Registrational Trial without causing a Local Law Issue, either Party may submit such matter for resolution in accordance with Section 15.3. (c) If, pursuant to Section 4.4.2(a), Zenas proposes a Global Registrational Trial and Licensee elects not to participate in such Global Registrational Trial, Zenas shall be entitled to enroll patients in such Global Registrational Trial in the Territory without Licensee’s prior written consent; provided, that (i) no Local Law Issue exists, (ii) Zenas’ Post-Study Drug Access Plan for the Territory is reasonably acceptable to Licensee, such Post-Study Drug Access Plan is consistent with Licensee’s then applicable SOPs for patients in Clinical Studies to access study drugs following the conclusion of such Clinical Studies, which SOPs would be provided to Zenas at Zenas’ request through the JSC, and Licensee would not be required to incur any costs or perform any material obligations associated with the implementation of such Post-Study Drug Access Plan for the Territory, (iii) pharmacovigilance matters are handled in the same manner as any Joint Global Study in accordance Section 5.7, (iv) enrolling patients in the Territory in such Global Registrational Trial could not reasonably be expected to have a material adverse effect on the Development or Commercialization of the Compound or the Products inside the Territory, and (v) Zenas provides to Licensee, through the JSC, a copy of the applicable clinical study design and protocol (including any changes thereto) and regular updates at JSC meetings on the clinical sites, clinical investigators and key opinion leaders that are involved in such Global Study; provided further, for the avoidance of doubt, that subject to Section 4.3, Licensee shall be permitted at any time to conduct its own Registrational Trial in the Territory, which Registrational Trial shall constitute a Local Study. (d) If, pursuant to Section 4.4.2(a), Zenas proposes a Global Non-Registrational Trial that includes clinical sites in the Territory and Licensee elects not to participate in such Global Non-Registrational Trial, Zenas shall be entitled to enroll patients in such Global Non-Registrational Trial in the Territory without Licensee’s prior written consent; provided that Zenas shall provide Licensee with regular updates through the JSC regarding any activities it conducts in the Territory, including identifying clinical sites. (e) If Licensee elects to participate in the Global Study proposed by Zenas pursuant to Section 4.4.2(a), Licensee shall share the costs for such Global Study in accordance with Section 4.4.5(b). (f) For clarity, Zenas may, in its sole discretion, decide whether to participate in any Licensee-proposed Global Study. If Zenas declines to participate in such Licensee-proposed Global Study, then Licensee shall not have the right to perform such Licensee-proposed Global Study outside the Territory, and such study shall not be deemed as a “Global Study” under this Agreement. (g) [***]

Licensee Participation. Licensee (ai) If Zenas wishes to perform a shall, at its sole cost and expense, participate in specific Existing Global Study that includes Studies in accordance with the Clinical Development Plan by coordinating clinical trial sites in the TerritoryLicensed Territory for such Existing Global Studies to enroll a certain percentage of the total subjects for each such Existing Global Studies, Zenas shall prepare and provide to the JSC (i) a Development Plan relating to such Global Study and (ii) may agree to participate in such other Global Studies presented by Mirati pursuant to Section 5.4(e) (each of the case of a Existing Global Registrational TrialStudies that Licensee participates in and any such future Global Studies that Licensee participates in, a Post-“Joint Global Study”), provided that (A) upon any suspension initiated by Mirati with respect to any Joint Global Study, Licensee shall be relieved of obligations to meet the Enrollment Period (if applicable) or [***] Enrollment Allocation with respect to such Joint Global Study Drug Access Plan that would have applied during such period of suspension, and upon [***] of such suspended Joint Global Study, the Parties shall agree to either (1) extend the Enrollment Period by a period of [***] and agree to new [***] Enrollment Allocation for any additional [***] of the Territoryextended Enrollment Period with respect to such Joint Global Study; or (2) reduce the Minimum Enrollment Threshold for such Joint Global Study by [***] and, if adopting (1) or (2) would be insufficient to eliminate the negative effect of Mirati’s suspension on Licensee’s ability to meet the Enrollment Period, [***] Enrollment Allocation, or Minimum Enrollment Threshold, the Parties will in good faith agree to further adjustment to the Enrollment Period, [***] Enrollment Allocation, or Minimum Enrollment Threshold, with respect to such Joint Global Study; and (B) after any cessation initiated by Mirati with respect to any Joint Global Study in its entirety, Licensee shall be relieved of the obligations with respect to such Joint Global Study set forth in Section 5.4, Section 5.6, Section 5.8, and Section 6.3(b)(i) (for clarity, Licensee’s obligation to provide Mirati with access or copies to Reference Data, Regulatory Filing, and correspondence generated prior to such cessation shall be unaffected). Licensee shall have be responsible for all activities (if any) associated with conducting each Joint Global Study in the Licensed Territory set forth in the Clinical Development Plan existing as of the Effective Date and each additional Joint Global Study as outlined in the plan for such Joint Global Study as mutually agreed by the Parties and any additional Joint Global Study so agreed between the Parties shall be included in an amendment to the Clinical Development Plan. With respect to each Existing Global Study, Licensee shall recruit and enroll in a timely manner [***] (or such other percentage as agreed to by Mirati) of the total number of patients to be treated under the applicable protocol for such Joint Global Study (each applicable percentage, a “Minimum Enrollment Threshold”) with respect to the applicable enrollment period for such Joint Global Study (the “Election Enrollment Period”) in accordance with the Clinical Development Plan. With respect to elect each Existing Global Study, [***] shall timely meet the [***] Enrollment Allocation, and provide the JDC [***] updates as to participate whether it expects to meet each [***] Enrollment Allocation, and the Parties (through the JDC) shall cooperate in such good faith to assist Licensee in meeting each [***] Enrollment Allocation. The [***] Enrollment Allocation for certain Existing Global Studies are set forth in Exhibit 5.4 attached hereto. Licensee shall be solely responsible for any and all costs (including costs of supply for any combination agents under the applicable Joint Global Study andprotocol) incurred by or on behalf of Licensee to meet the applicable Minimum Enrollment Threshold. Mirati may, upon such electionin its sole discretion, such request Licensee to enroll a number of patients for any Joint Global Study in excess of the applicable Minimum Enrollment Threshold. If Licensee agrees to enroll such number of excess patients, within [***] of Licensee’s receipt of Mirati’s request, Licensee shall submit to Mirati for Mirati’s review and written approval a detailed budget of all estimated costs (including Manufacturing Costs) to be deemed incurred by or on behalf of Licensee for such excess enrollment (such approved budget, the “Excess Enrollment Budget”). Mirati shall reimburse Licensee for documented costs actually incurred by or on behalf of Licensee up to [***] of the Excess Enrollment Budget on a “[***] basis. For avoidance of doubt, if with respect to a given Joint Global Study”, and the JSC shall review and approve total patients to be enrolled based on the applicable Clinical Development Plan for such Joint Global Study (such Development Plan being a “Joint Development Plan”) and a budget are enrolled prior to the end of the Enrollment Period for such Joint Global Study (a such date the total patient enrollment is achieved, the “Joint Development Plan BudgetEnrollment Completion Date”). Within [***] of , then starting from the Effective Enrollment Completion Date, the Parties will mutually agree on a Post-Study Drug Access Plan for the Territory that is consistent with Licensee’s then applicable standard operating procedures (“SOPs”) for Licensee would not be obligated to enroll any more patients in Clinical Studies to access study drugs following the conclusion as part of such Clinical Studies, which SOPs would be provided to Zenas at Zenas’s request through the JSCJoint Global Study, and any costs associated Licensee shall be relieved of all its obligations under Section 5.4(b) or Section 5.4(c) with respect to such Joint Global Study, subject to the implementation of such Post-Study Drug Access Plan for the Territory would be paid by Licensee. following: [***]. (b) If Licensee declines to participate in a Global Study that is a Global Registrational Trial and Licensee has determined that the conduct of such Global Registrational Trial using clinical sites in the Territory violates Applicable Laws or internationally accepted guidance (such as Declaration of Helsinki or ICH GCP principles) in the jurisdictions in the Territory in which such clinical sites will be located (a “Local Law Issue”), Licensee shall notify Zenas in writing of such determination prior to the expiration of the Election Period, which written notice shall include details supporting Licensee’s determination that there is a Local Law Issue. If Licensee does not provide written notice of a Local Law Issue prior to the expiration of the Election Period, then no Local Law Issue will be deemed to exist for purposes of Section 4.4.2(c). The Parties shall promptly meet to discuss any Local Law Issue alleged by Licensee and any potential solutions relating thereto. If the Parties are unable to agree, within a [***] period after Zenas receives Licensee’s written notice of a Local Law Issue, (A) that a Local Law Issue exists, or (B) on a potential solution that will permit Zenas to proceed with such Global Registrational Trial without causing a Local Law Issue, either Party may submit such matter for resolution in accordance with Section 15.3. (c) If, pursuant to Section 4.4.2(a), Zenas proposes a Global Registrational Trial and Licensee elects not to participate in such Global Registrational Trial, Zenas shall be entitled to enroll patients in such Global Registrational Trial in the Territory without Licensee’s prior written consent; provided, that (i) no Local Law Issue exists, (ii) Zenas’ Post-Study Drug Access Plan for the Territory is reasonably acceptable to Licensee, such Post-Study Drug Access Plan is consistent with Licensee’s then applicable SOPs for patients in Clinical Studies to access study drugs following the conclusion of such Clinical Studies, which SOPs would be provided to Zenas at Zenas’ request through the JSC, and Licensee would not be required to incur any costs or perform any material obligations associated with the implementation of such Post-Study Drug Access Plan for the Territory, (iii) pharmacovigilance matters are handled in the same manner as any Joint Global Study in accordance Section 5.7, (iv) enrolling patients in the Territory in such Global Registrational Trial could not reasonably be expected to have a material adverse effect on the Development or Commercialization of the Compound or the Products inside the Territory, and (v) Zenas provides to Licensee, through the JSC, a copy of the applicable clinical study design and protocol (including any changes thereto) and regular updates at JSC meetings on the clinical sites, clinical investigators and key opinion leaders that are involved in such Global Study; provided further, for the avoidance of doubt, that subject to Section 4.3, Licensee shall be permitted at any time to conduct its own Registrational Trial in the Territory, which Registrational Trial shall constitute a Local Study. (d) If, pursuant to Section 4.4.2(a), Zenas proposes a Global Non-Registrational Trial that includes clinical sites in the Territory and Licensee elects not to participate in such Global Non-Registrational Trial, Zenas shall be entitled to enroll patients in such Global Non-Registrational Trial in the Territory without Licensee’s prior written consent; provided that Zenas shall provide Licensee with regular updates through the JSC regarding any activities it conducts in the Territory, including identifying clinical sites. (e) If Licensee elects to participate in the Global Study proposed by Zenas pursuant to Section 4.4.2(a), Licensee shall share the costs for such Global Study in accordance with Section 4.4.5(b). (f) For clarity, Zenas may, in its sole discretion, decide whether to participate in any Licensee-proposed Global Study. If Zenas declines to participate in such Licensee-proposed Global Study, then Licensee shall not have the right to perform such Licensee-proposed Global Study outside the Territory, and such study shall not be deemed as a “Global Study” under this Agreement. (g) [***]

Licensee Participation. Licensee (ai) If Zenas wishes to perform a shall, at its sole cost and expense, participate in specific Existing Global Study that includes Studies in accordance with the Clinical Development Plan by coordinating clinical trial sites in the TerritoryLicensed Territory for such Existing Global Studies to enroll a certain percentage of the total subjects for each such Existing Global Studies, Zenas shall prepare and provide to the JSC (i) a Development Plan relating to such Global Study and (ii) may agree to participate in such other Global Studies presented by Mirati pursuant to Section 5.4(e) (each of the case of a Existing Global Registrational TrialStudies that Licensee participates in and any such future Global Studies that Licensee participates in, a Post-“Joint Global Study”), provided that (A) upon any suspension initiated by Mirati with respect to any Joint Global Study, Licensee shall be relieved of obligations to meet the Enrollment Period (if applicable) or [***] Enrollment Allocation with respect to such Joint Global Study Drug Access Plan that would have applied during such period of suspension, and upon [***] of such suspended Joint Global Study, the Parties shall agree to either (1) extend the Enrollment Period by a period of [***] and agree to new [***] Enrollment Allocation for any additional [***] of the Territoryextended Enrollment Period with respect to such Joint Global Study; or (2) reduce the Minimum Enrollment Threshold for such Joint Global Study by [***] and, if adopting (1) or (2) would be insufficient to eliminate the negative effect of Mirati’s suspension on Licensee’s ability to meet the Enrollment Period, [***] Enrollment Allocation, or Minimum Enrollment Threshold, the Parties will in good faith agree to further adjustment to the Enrollment Period, [***] Enrollment Allocation, or Minimum Enrollment Threshold, with respect to such Joint Global Study; and (B) after any cessation initiated by Mirati with respect to any Joint Global Study in its entirety, Licensee shall be relieved of the obligations with respect to such Joint Global Study set forth in Section 5.4, Section 5.6, Section 5.8, and Section 6.3(b)(i) (for clarity, Licensee’s obligation to provide Mirati with access or copies to Reference Data, Regulatory Filing, and correspondence generated prior to such cessation shall be unaffected). Licensee shall have be responsible for all activities (if any) associated with conducting each Joint Global Study in the Licensed Territory set forth in the Clinical Development Plan existing as of the Effective Date and each additional Joint Global Study as outlined in the plan for such Joint Global Study as mutually agreed by the Parties and any additional Joint Global Study so agreed between the Parties shall be included in an amendment to the Clinical Development Plan. With respect to each Existing Global Study, Licensee shall recruit and enroll in a timely manner [***] (or such other percentage as agreed to by Mirati) of the total number of patients to be treated under the applicable protocol for such Joint Global Study (each applicable percentage, a “Minimum Enrollment Threshold”) with respect to the applicable enrollment period for such Joint Global Study (the “Election Enrollment Period”) in accordance with the Clinical Development Plan. With respect to elect each Existing Global Study, [***] shall timely meet the [***] Enrollment Allocation, and provide the JDC [***] updates as to participate whether it expects to meet each [***] Enrollment Allocation, and the Parties (through the JDC) shall cooperate in such good faith to assist Licensee in meeting each [***] Enrollment Allocation. The [***] Enrollment Allocation for certain Existing Global Studies are set forth in Exhibit 5.4 attached hereto. Licensee shall be solely responsible for any and all costs (including costs of supply for any combination agents under the applicable Joint Global Study andprotocol) incurred by or on behalf of Licensee to meet the applicable Minimum Enrollment Threshold. Mirati may, upon such electionin its sole discretion, such request Licensee to enroll a number of patients for any Joint Global Study in excess of the applicable Minimum Enrollment Threshold. If Licensee agrees to enroll such number of excess patients, within [***] of Licensee’s receipt of Mirati’s request, Licensee shall submit to Mirati for Mirati’s review and written approval a detailed budget of all estimated costs (including Manufacturing Costs) to be deemed incurred by or on behalf of Licensee for such excess enrollment (such approved budget, the “Excess Enrollment Budget”). Mirati shall reimburse Licensee for documented costs actually incurred by or on behalf of Licensee up to [***] of the Excess Enrollment Budget on a “[***] basis.For avoidance of doubt, if with respect to a given Joint Global Study”, and the JSC shall review and approve total patients to be enrolled based on the applicable Clinical Development Plan for such Joint Global Study (such Development Plan being a “Joint Development Plan”) and a budget are enrolled prior to the end of the Enrollment Period for such Joint Global Study (a such date the total patient enrollment is achieved, the “Joint Development Plan BudgetEnrollment Completion Date”), then starting from the Enrollment Completion Date, Licensee would not be obligated to enroll any more patients as part of such Joint Global Study, and Licensee shall be relieved of all its obligations under Section 5.4(b) or Section 5.4(c) with respect to such Joint Global Study, subject to the following: [***]. Within [***] of the Effective Date, the Parties will mutually agree on a Post-Study Drug Access Plan for the Territory that is consistent with Licensee’s then applicable standard operating procedures (“SOPs”) for patients in Clinical Studies to access study drugs following the conclusion of such Clinical Studies, which SOPs would be provided to Zenas at Zenas’s request through the JSC, and any costs associated with the implementation of such Post-Study Drug Access Plan for the Territory would be paid by Licensee. [***]. (b) If Licensee declines to participate in a Global Study that is a Global Registrational Trial and Licensee has determined that the conduct of such Global Registrational Trial using clinical sites in the Territory violates Applicable Laws or internationally accepted guidance (such as Declaration of Helsinki or ICH GCP principles) in the jurisdictions in the Territory in which such clinical sites will be located (a “Local Law Issue”), Licensee shall notify Zenas in writing of such determination prior to the expiration of the Election Period, which written notice shall include details supporting Licensee’s determination that there is a Local Law Issue. If Licensee does not provide written notice of a Local Law Issue prior to the expiration of the Election Period, then no Local Law Issue will be deemed to exist for purposes of Section 4.4.2(c). The Parties shall promptly meet to discuss any Local Law Issue alleged by Licensee and any potential solutions relating thereto. If the Parties are unable to agree, within a [***] period after Zenas receives Licensee’s written notice of a Local Law Issue, (A) that a Local Law Issue exists, or (B) on a potential solution that will permit Zenas to proceed with such Global Registrational Trial without causing a Local Law Issue, either Party may submit such matter for resolution in accordance with Section 15.3. (c) If, pursuant to Section 4.4.2(a), Zenas proposes a Global Registrational Trial and Licensee elects not to participate in such Global Registrational Trial, Zenas shall be entitled to enroll patients in such Global Registrational Trial in the Territory without Licensee’s prior written consent; provided, that (i) no Local Law Issue exists, (ii) Zenas’ Post-Study Drug Access Plan for the Territory is reasonably acceptable to Licensee, such Post-Study Drug Access Plan is consistent with Licensee’s then applicable SOPs for patients in Clinical Studies to access study drugs following the conclusion of such Clinical Studies, which SOPs would be provided to Zenas at Zenas’ request through the JSC, and Licensee would not be required to incur any costs or perform any material obligations associated with the implementation of such Post-Study Drug Access Plan for the Territory, (iii) pharmacovigilance matters are handled in the same manner as any Joint Global Study in accordance Section 5.7, (iv) enrolling patients in the Territory in such Global Registrational Trial could not reasonably be expected to have a material adverse effect on the Development or Commercialization of the Compound or the Products inside the Territory, and (v) Zenas provides to Licensee, through the JSC, a copy of the applicable clinical study design and protocol (including any changes thereto) and regular updates at JSC meetings on the clinical sites, clinical investigators and key opinion leaders that are involved in such Global Study; provided further, for the avoidance of doubt, that subject to Section 4.3, Licensee shall be permitted at any time to conduct its own Registrational Trial in the Territory, which Registrational Trial shall constitute a Local Study. (d) If, pursuant to Section 4.4.2(a), Zenas proposes a Global Non-Registrational Trial that includes clinical sites in the Territory and Licensee elects not to participate in such Global Non-Registrational Trial, Zenas shall be entitled to enroll patients in such Global Non-Registrational Trial in the Territory without Licensee’s prior written consent; provided that Zenas shall provide Licensee with regular updates through the JSC regarding any activities it conducts in the Territory, including identifying clinical sites. (e) If Licensee elects to participate in the Global Study proposed by Zenas pursuant to Section 4.4.2(a), Licensee shall share the costs for such Global Study in accordance with Section 4.4.5(b). (f) For clarity, Zenas may, in its sole discretion, decide whether to participate in any Licensee-proposed Global Study. If Zenas declines to participate in such Licensee-proposed Global Study, then Licensee shall not have the right to perform such Licensee-proposed Global Study outside the Territory, and such study shall not be deemed as a “Global Study” under this Agreement. (g) [***]= CERTAIN CONFIDENTIAL INFORMATION OMITTED