Common use of Responsibilities of the JDC Clause in Contracts

Responsibilities of the JDC. The JDC shall have the responsibility and authority with respect to Phase I Plans for Phase I Completed Original Products and the clinical development of C4T Co-Dev Products to: (a) Approve each Phase I Plan (if for a Phase I Completed Original Product) and Development Plan (if for a C4T Co-Dev Product); (b) Approve any revisions to the Phase I Plan and Development Plan under (a); (c) Review and oversee the execution of the Phase I Plan and Development Plan under (a) and oversee the progress of activities under such plans; (d) Oversee the Phase I Study of Phase I Completed Original Products; (e) Oversee the Clinical Studies of C4T Co-Dev Products; (f) Establish timelines and criteria for development decision points; (g) Review and discuss filing of the IND for each Phase I Completed Original Product; (h) Determine whether development success criteria have been met (Phase I Data Package); (i) Review the efforts of the Parties and allocate those resources for the Phase I Plan and Clinical Studies; (j) review regular updates to the Shared Development Cost Budget for Development Costs as set forth in Sections 6.2.2 and 6.3.2; (k) identify appropriate resources necessary to conduct the Development Plan; (l) establish and set expectations and mandates for its JOT; (m) create or disband its JOT as deemed appropriate; (n) oversee its JOT, if applicable; (o) align on the drug substance and drug product strategy, including stability program, and its execution for the drug product used for the Phase I Studies of Phase I Completed Original Products; (p) oversee manufacture and release of drug substance and drug product batches to be used for Phase I Studies of Phase I Completed Original Products; (p) depending on the Clinical Studies following Phase I Studies of C4T Co-Dev Products, approve the appropriate CMC strategy for drug substance and drug product to be used in either Phase II Studies or Phase III Studies and oversee its execution; (q) define the drug substance and drug product specifications for the batches used for Phase I Studies of Phase I Completed Original Products and any batches made prior to Roche exercising the Roche Option Right of Phase I Completed Original Products for the subsequent Phase II Studies and/or Phase III Studies after exercise of the Roche Option Right; and (r) Attempt to solve any disputes on an informal basis. The JDC shall have no responsibility and authority other than that expressly set forth in this Section 11.10.

Responsibilities of the JDC. The JDC Joint Development Committee shall have be responsible for performing the responsibility and authority with respect to Phase I Plans for Phase I Completed Original Products and the clinical development of C4T Co-Dev Products tofollowing functions: (a) Approve each Phase I Plan (if for a Phase I Completed Original Product) review progress of Development and regulatory approval of Collaboration Products as reported by the Joint Development Plan (if for a C4T Co-Dev Product)Team; (b) Approve any revisions address and coordinate the resolution of issues that may arise relating to the Phase I Plan Initial Knowledge Transfer and Development Plan the Ongoing Knowledge Transfer (in each case other than to the extent relating to activities under (athe Research Plan); (c) Review review and oversee the execution of the Phase I Plan and Development Plan under (a) and oversee the progress of activities under such plans;decide [***] (d) Oversee review and decide whether to (i) approve amendments to the Phase I Study of Phase I Completed Original ProductsGDP as proposed by the Joint Development Team or (ii) amend the GDP to include any additional Clinical Studies proposed by either Party (including Proposed Studies); (e) Oversee approve new and amended GDP Budgets as proposed by the Clinical Studies of C4T Co-Dev ProductsJoint Development Team; (f) Establish timelines review and decide whether to approve any Proposed Studies as BioNTech Studies based upon the criteria for development decision pointsset forth in Section 4.5.2; (g) Review review and discuss filing of decide whether to approve any GTT Proposed Studies as BioNTech Studies based upon the IND for each Phase I Completed Original Productcriteria set forth in Section 4.5.3; (h) Determine review and decide whether development success to approve any proposed Melanoma Follow-Up Study based upon the criteria have been met (Phase I Data Package)set forth in Section 4.3.2; (i) Review oversee the efforts Conduct and modification of Ongoing Clinical Studies (as set forth in Section 4.3.1), any Melanoma Follow-Up Studies (as set forth in Section 4.3.2) and any BioNTech Studies (as set forth in Section 4.5.4), and to review and decide whether to approve any material deviations from (i) the Ongoing Clinical Studies as such Clinical Studies exist as of the Parties and allocate those resources for Execution Date (as set forth in Section 4.3.1), (ii) any Melanoma Follow-Up Studies as previously approved by the Phase I Plan and Clinical StudiesJDC (as set forth in Section 4.3.2) or (iii) any BioNTech Studies as previously approved by the JDC (as set forth in Section 4.5.4); (j) together with the Joint Research Committee, review regular updates the annual Publication Plan developed by the Joint Development Team together with the Joint Research Team, and approve [***] the portion of such plan addressed to the Shared Development Cost Budget for Development Costs as set forth in Sections 6.2.2 and 6.3.2publications; (k) identify appropriate resources necessary to conduct ensure that each Party keeps the Development PlanJDC informed regarding all material activities Conducted or otherwise performed by such Party under this Agreement that are within the purview of the JDC, including status updates of (i) BioNTech’s progress toward Developing BioNTech Collaboration Products (including Conducting BioNTech Studies) and (ii) Genentech’s progress toward Developing Genentech Collaboration Products (including Conducting Genentech Studies); (l) establish and set expectations and mandates for its JOT;perform such other functions as specified in this Agreement or as agreed to by the Parties in writing; and (m) create oversee all Clinical Studies, comparator studies or disband its JOT as deemed appropriate; (n) oversee its JOTinvestigator-sponsored studies of Collaboration Products Conducted by the Parties, if applicable; (o) align on regardless of which Party Conducts the drug substance and drug product strategystudies or has final decision-making authority in matters related to such studies. For clarity, including stability programall “Non-Clinical GDP Activities” included in the GDP shall not be subject to the decision-making by the JDC, and its execution for but shall be controlled by the drug product used for the Phase I Studies of Phase I Completed Original Products; (p) oversee manufacture and release of drug substance and drug product batches to be used for Phase I Studies of Phase I Completed Original Products; (p) depending on the Clinical Studies following Phase I Studies of C4T Co-Dev Products, approve the appropriate CMC strategy for drug substance and drug product to be used in either Phase II Studies or Phase III Studies and oversee its execution; (q) define the drug substance and drug product specifications for the batches used for Phase I Studies of Phase I Completed Original Products and any batches made prior to Roche exercising the Roche Option Right of Phase I Completed Original Products for the subsequent Phase II Studies and/or Phase III Studies after exercise of the Roche Option Right; and (r) Attempt to solve any disputes on an informal basis. The JDC shall have no responsibility and authority other than that expressly set forth in this Section 11.10JRC.

Responsibilities of the JDC. The JDC shall have the responsibility and authority with respect to Phase I Plans for Phase I Completed Original Products and the clinical development of C4T Co-Dev Products to: (a) Approve each develop and approve initial Phase I Plan (if for a Phase I Completed Original Product) Plans and Development Plan (if for a C4T Co-Dev Product)any revisions thereto; (b) Approve approve Development Plans and any revisions to the Phase I Plan and Development Plan under (a)thereto; (c) Review review and oversee the execution of the Phase I Plan Plans and Development Plan under (a) and oversee the progress of activities under such plansPlans; (d) Oversee oversee the initial Phase I Study Studies for Products prior to Roche’s exercise of Phase I Completed Original Productsan Option Right; (e) Oversee the Clinical Studies determine and maintain a list of C4T Co-Dev Productsall Collaboration Targets in order of advancement of status; (f) Establish designate the MTD for each Product; (g) designate the cut-off date for the data resulting from the Phase I Studies conducted by the Parties for each Collaboration Target in accordance with Section 3.1.3; (h) oversee development of Licensed Products after Roche’s exercise of an Option Right; (i) establish timelines and criteria for development decision points; (gj) Review and discuss filing of the IND for each Phase I Completed Original Product; (h) Determine determine whether development success criteria have been met (Phase I Data Package); (i) Review the efforts of the Parties and allocate those resources for the Phase I Plan and Clinical Studies; (j) review regular updates to the Shared Development Cost Budget for Development Costs as set forth in Sections 6.2.2 and 6.3.2met; (k) review the development efforts of the Parties, including for Companion Diagnostics; (l) identify appropriate resources necessary to conduct the Phase I Plans and Development Plan; (l) establish and set expectations and mandates for its JOTPlans; (m) create or disband its JOT as deemed appropriatereview and approve Phase I Development Costs and Development Costs in accordance with the allocations set forth in Sections 12.5 and 12.6; (n) oversee its JOT, if applicable; (o) align on the drug substance and drug product strategy, including stability program, and its execution for the drug product used for the Phase I Studies of Phase I Completed Original Products; (p) oversee manufacture and release of drug substance and drug product batches to be used for Phase I Studies of Phase I Completed Original Products; (p) depending on the Clinical Studies following Phase I Studies, devise at the latest upon start of Phase I Studies of C4T Co-Dev Products, approve the appropriate CMC CMC-strategy for drug substance and drug product to be used in either Phase II Studies or Phase III Studies and oversee its executionexecution (with Roche deciding where such manufacture of Phase II and Phase III Study supply, both for drug substance and drug product, should occur (including prior to Roche exercising its Option Right); (qo) define the drug substance and drug product specifications for the batches used for Phase I Studies of Phase I Completed Original Products and any batches made prior to Roche exercising the Roche its Option Right of Phase I Completed Original Products for the subsequent Phase II Studies and/or Phase III Studies after exercise of the Roche Option RightRight exercise; (p) determine whether a […***…] or should be re-designated pursuant to Section 5.1.3; (q) establish, set expectations and mandates for, oversee and disband JOTs; (r) recommend action items to each Party’s respective decision making bodies; and (rs) Attempt attempt to solve resolve any disputes on an informal basis. The JDC shall have all responsibility and authority regarding the clinical development of Products and Licensed Products, other than as expressly set forth in this Agreement. The JDC shall have no responsibility and authority other than that expressly set forth in this Section 11.10Section, unless mutually agreed by the Parties.

Responsibilities of the JDC. The JDC shall have the responsibility and authority with respect to Phase I Plans for Phase I Completed Original Products and the clinical development of C4T Co-Dev Products to:: ​ (a) Approve each develop and approve initial Phase I Plan (if for a Phase I Completed Original Product) Plans and Development Plan (if for a C4T Co-Dev Product);any revisions thereto; ​ (b) Approve approve Development Plans and any revisions to the Phase I Plan and Development Plan under (a)thereto; (c) Review review and oversee the execution of the Phase I Plan Plans and Development Plan under (a) and oversee the progress of activities under such plansPlans; (d) Oversee oversee the initial Phase I Study Studies for Products prior to Roche’s exercise of Phase I Completed Original Products;an Option Right; ​ (e) Oversee the Clinical Studies determine and maintain a list of C4T Co-Dev Productsall Collaboration Targets in order of advancement of status; (f) Establish designate the MTD for each Product; ​ (g) designate the cut-off date for the data resulting from the Phase I Studies conducted by the Parties for each Collaboration Target in accordance with Section 3.1.3; ​ (h) oversee development of Licensed Products after Roche’s exercise of an Option Right; (i) establish timelines and criteria for development decision points; (g) Review and discuss filing of the IND for each Phase I Completed Original Product; (h) Determine whether development success criteria have been met (Phase I Data Package); (i) Review the efforts of the Parties and allocate those resources for the Phase I Plan and Clinical Studies;; ​ (j) review regular updates to the Shared Development Cost Budget for Development Costs as set forth in Sections 6.2.2 and 6.3.2determine whether development criteria have been met; (k) review the development efforts of the Parties, including for Companion Diagnostics; (l) identify appropriate resources necessary to conduct the Phase I Plans and Development Plan; (l) establish and set expectations and mandates for its JOT;Plans; ​ (m) create or disband its JOT as deemed appropriate;review and approve Phase I Development Costs and Development Costs in accordance with the allocations set forth in Sections 12.5 and 12.6; ​ (n) oversee its JOT, if applicable; (o) align on the drug substance and drug product strategy, including stability program, and its execution for the drug product used for the Phase I Studies of Phase I Completed Original Products; (p) oversee manufacture and release of drug substance and drug product batches to be used for Phase I Studies of Phase I Completed Original Products; (p) depending on the Clinical Studies following Phase I Studies, devise at the latest upon start of Phase I Studies of C4T Co-Dev Products, approve the appropriate CMC CMC-strategy for drug substance and drug product to be used in either Phase II Studies or Phase III Studies and oversee its execution;execution (with Roche deciding where such manufacture of Phase II and Phase III Study supply, both for drug substance and drug product, should occur (including prior to Roche exercising its Option Right); ​ (qo) define the drug substance and drug product specifications for the batches used for Phase I Studies of Phase I Completed Original Products and any batches made prior to Roche exercising the Roche its Option Right of Phase I Completed Original Products for the subsequent Phase II Studies and/or Phase III Studies after exercise of the Roche Option RightRight exercise; (p) determine whether a […***…] or should be re-designated pursuant to Section 5.1.3; and​ (q) establish, set expectations and mandates for, oversee and disband JOTs; ​ (r) Attempt recommend action items to solve each Party’s respective decision making bodies; and ​ (s) attempt to resolve any disputes on an informal basis. ​ The JDC shall have all responsibility and authority regarding the clinical development of Products and Licensed Products, other than as expressly set forth in this Agreement. The JDC shall have no responsibility and authority other than that expressly set forth in this Section 11.10Section, unless mutually agreed by the Parties.