Common use of Functions and Authority Clause in Contracts

Functions and Authority. The JSC will be responsible for overseeing the Research Collaboration and the Research Programs, Phase I Clinical Trials, Phase I/II Clinical Trials, and Phase II Clinical Trials (for so long as Codiak or its Affiliates are conducting such trials), and any Development after the exercise by Codiak of its Development and Commercialization Option, and will oversee the activities under the Co-Promotion Agreement(s), if applicable, as set forth below. Its functions (which may be delegated to any subcommittees) include: i. Oversee the conduct of the Research Programs, the EDPs and the JDPs, including reviewing any expected or actual delays in the conduct of the activities thereunder; ii. Oversee the commencement of IND-Enabling Studies and designation of Development Candidates; iii. Oversee development of regulatory strategies for the Licensed Compounds and Licensed Products; iv. Review and approve Work Plans (subject to Section 2.3), EDPs, JDPs, and Shared Territory Commercialization Plans and, to the extent applicable, corresponding budgets and amendments to any of the foregoing, including in connection with Schedule 4.3.3; v. As contemplated in Section 2.4 and Section 4.6, approve subcontractors, decide which types of subcontractor agreements do not require review, and otherwise consider ways to streamline review of subcontracting; vi. Coordinate the Manufacturing activities and technology transfer activities of Codiak and its Affiliates and Jazz and its Affiliates hereunder and under any supply agreement entered into by the Parties or their respective Affiliates; vii. Facilitate the flow of information between the Parties regarding Development, and the transfer of Codiak Know-How and Research Program Materials in accordance with the applicable Work Plan; viii. Resolve issues referred to the JSC by the Alliance Managers or any subcommittee created by the JSC; ix. Review reports received from either Party as contemplated herein; x. Coordinate the logistics of the Parties’ financial reporting obligations; xi. Following exercise of the Development and Commercialization Option, review and discuss Jazz’s reports and updates to the JSC regarding its Commercialization activities and plans for Licensed Products in the Shared Territory; xii. Following exercise of the Development and Commercialization Option, (1) review and update financial forecasts at least quarterly to ensure actual and anticipated spend is within the approved Commercial Budget; and (2) to the extent that any Commercialization costs and expenses apply to both the Shared Territory and the ROW, reasonably allocate such costs between the Shared Territory and the ROW based on the expected benefit in the Shared Territory and the ROW as determined by the composition of the expected target audience or any other reasonable criteria determined by the JSC; xiii. Discuss and attempt to resolve financial disputes and accounting issues, including the interpretation of relevant defined financial terms, in order to achieve the proper allocation of Development Costs and the sharing of Net Profit/Net Losses in the manner set forth in this Agreement; and xiv. Such other matters as the Parties may mutually agree in writing or as are assigned to the JSC herein.

Functions and Authority. The JSC will be responsible for Joint Development Committee shall have responsibility for: (1) overseeing the Research Collaboration and the Research Programs, Phase I Clinical Trials, Phase I/II Clinical Trials, and Phase II Clinical Trials (for so long as Codiak or its Affiliates are conducting such trials), and any Mersana Early Development after the exercise by Codiak of its Development and Commercialization Option, and will oversee the activities under the Co-Promotion Agreement(s), if applicable, as set forth below. Its functions under Section 4.1; (which may 2) overseeing any Licensee Early Development as set forth under Section 4.2; (3) setting overall strategic objectives related to the Development of Licensed Products in the Field throughout the world (but such objectives shall not be delegated construed to any subcommittees) include: i. Oversee prevent the conduct of Independent Development pursuant to Section 4.7); (4) overseeing the Research Programsdesign and planning of Clinical Trials to be included in and conducted under the Global Development Plan, including the EDPs development of protocols and budgets for such Clinical Trials and determining which Party shall serve as the operational lead for each such Clinical Trial; (5) reviewing, commenting on, and recommending for review and approval by the Joint Steering Committee, as applicable, any amendments or revisions to the Global Development Plan, and the JDPsbudget relating thereto (other than as expressly reserved for the Joint Manufacturing Committee under Section 3.3.3(b)); (6) overseeing the Development activity conducted under this Agreement other than Independent Development, including and facilitating reasonable transparency with respect to Independent Development; (7) establishing the reporting obligations of the Parties with respect to Development activities and reviewing any expected all such Development reports provided in accordance with Section 4.5; (8) monitoring each Party’s performance against the then-current Global Development Plan, except to the extent such function is assigned to the Joint Manufacturing Committee; (9) establishing a medical affairs subcommittee to review all investigator-sponsored studies with respect to Licensed Products as to which a Party agrees to provide clinical supply or actual delays other support, where the other Party’s medical affairs subcommittee representatives may object only if they believe the study will have a material adverse effect on Commercialization of Licensed Products in the conduct of Mersana Territory, if such other Party is Mersana, or in the activities thereunderLicensee Territory, if such other Party is Licensee; provided that any dispute regarding an alleged material adverse effect shall be escalated to the Joint Development Committee; ii. Oversee the commencement of IND-Enabling Studies (10) reviewing and designation of Development Candidates; iii. Oversee development of commenting on Licensee’s regulatory strategies for obtaining and maintaining Regulatory Approvals for the sale of Licensed Compounds and Licensed ProductsProducts in the Field in the Licensee Territory; iv. Review and approve Work Plans (subject to Section 2.3), EDPs, JDPs, and Shared 11) reviewing proposed Development activities for Licensed Products for the Licensee Territory Commercialization Plans and, to that may impact Development of Licensed Products by Mersana for the extent applicable, corresponding budgets and amendments to any of the foregoing, including in connection with Schedule 4.3.3Mersana Territory; v. As contemplated (12) reviewing and commenting on Mersana’s regulatory strategies for obtaining and maintaining Regulatory Approvals for the sale of Licensed Products in Section 2.4 and Section 4.6, approve subcontractors, decide which types of subcontractor agreements do not require review, and otherwise consider ways to streamline review of subcontractingthe Field in the Mersana Territory; vi. Coordinate (13) reviewing proposed Development activities for Licensed Products for the Manufacturing activities and technology transfer activities Mersana Territory that may impact Development of Codiak and its Affiliates and Jazz and its Affiliates hereunder and under any supply agreement entered into Licensed Products by Licensee for the Parties or their respective AffiliatesLicensee Territory; vii. Facilitate (14) facilitating the flow exchange of information between the Parties under this Agreement regarding Development, and the transfer of Codiak Know-How and Research Program Materials in accordance with the applicable Work Plan; viii. Resolve issues referred to the JSC by the Alliance Managers or any subcommittee created by the JSC; ix. Review reports received from either Party as contemplated herein; x. Coordinate the logistics of the Parties’ financial reporting obligations; xi. Following exercise of strategy for implementing the Development and Commercialization Option, review and discuss Jazz’s reports and updates to the JSC regarding its Commercialization activities and plans for Licensed Products in the Shared Territory; xii. Following exercise of the Development and Commercialization Option, (1) review and update financial forecasts at least quarterly to ensure actual and anticipated spend is within the approved Commercial Budget; and (2) to the extent that any Commercialization costs and expenses apply to both the Shared Territory and the ROW, reasonably allocate such costs between the Shared Territory and the ROW based on the expected benefit in the Shared Territory and the ROW as determined by the composition of the expected target audience or any other reasonable criteria determined by the JSC; xiii. Discuss and attempt to resolve financial disputes and accounting issues, including the interpretation of relevant defined financial terms, in order to achieve the proper allocation of Development Costs and the sharing of Net Profit/Net Losses in the manner set forth in this Agreementactivities; and xiv. Such (15) performing such other matters functions as the Parties may mutually agree in writing or as are be assigned to the JSC hereinJoint Development Committee pursuant to this Agreement or as may be mutually agreed upon by the Parties in writing.