Common use of Role of Committees Clause in Contracts

Role of Committees. Subject to Section 2.1(b) and the other terms and conditions of this Agreement, the Parties shall establish: (i) a joint executive committee (the “Joint Executive Committee” or “JEC”) that will oversee the Collaboration and facilitate communications between the Parties with respect to the Development, Regulatory Approval, and Commercialization of Committee-Governed Products hereunder; and (ii) three (3) specialized joint committees consisting of one to focus on each of the following areas arising out of the Collaboration: (A) Development and Regulatory Approval and other regulatory matters (such committee, the “Joint Development and Regulatory Committee” or “JDC”); (B) Commercialization (such committee, the “Joint Commercialization Committee” or “JCC”); and (C) financial issues (such committee, the “Joint Finance Committee” or “JFC”). Each Committee shall have the responsibilities and authority allocated to it in this Article 2 and elsewhere in this Agreement. It is contemplated that: (X) all significant matters (other than Party Implementation Matters, as defined in Section 2.6(c)(ii)) relating to the pre-clinical and clinical Development of Committee-Governed Products and the Commercialization of Co-Developed Products, in each case under this Agreement will be addressed by the applicable first-tier Committees (i.e., the JDC, the JCC, or the JFC) and, if appropriate, by the JEC, as contemplated by Section 2.6(c); and (Y) the Parties’ respective activities under this Agreement (including Party Implementation Matters) will be reported to the relevant Committees in a reasonable and appropriate level of detail. Each of the JDC, JCC, and the JFC shall provide, on a [*] basis (unless otherwise requested by the JEC), updates on its activities and achievements to the JEC for review and comment. The Parties intend that their respective organizations will work together to assure the success of the Collaboration.

Role of Committees. Subject to Section 2.1(b) and the other terms and conditions of this Agreement, the Parties shall establish: (i) a joint executive committee (the “Joint Executive Committee” or “JEC”) that will oversee the Collaboration and facilitate communications between the Parties with respect to the Development, Regulatory Approval, and Commercialization of Committee-Governed Products hereunder; and (ii) three four (34) specialized joint committees consisting of one to focus on each of the following areas arising out of the Collaboration: (A) discovery efforts in connection with Screening Programs, Lead Op Programs, Provisional Collaboration Programs and Collaboration Programs, as described in Article 3 (such committee, the “Joint Research Committee” or “JRC”); (B) Development and Regulatory Approval and other regulatory matters (such committee, the “Joint Development and Regulatory Committee” or “JDC”); (BC) Commercialization (such committee, the “Joint Commercialization Committee” or “JCC”); and (CD) financial issues (such committee, the “Joint Finance Committee” or “JFC”). Each Committee shall have the responsibilities and authority allocated to it in this Article 2 and elsewhere in this Agreement. It is contemplated that: (X) all significant matters (other than Party Implementation Matters, as defined in Section 2.6(c)(ii2.7(c)(ii)) relating to to: (I) the discovery and pre-clinical Development of Collaboration Compounds; and (II) the clinical Development of Committee-Governed Products and the Commercialization of Co-Developed Promotion Products, in each case under this Agreement will be addressed by the applicable first-tier Committees (i.e., the JRC, the JDC, the JCC, or the JFC) and, if appropriate, by the JEC, as contemplated by Section 2.6(c2.7(c); and (Y) the Parties’ respective activities under this Agreement (including Party Implementation Matters) will be reported to the relevant Committees in a reasonable and appropriate level of detail. Each of the JRC (to the extent applicable), JDC, JCC, and the JFC shall provide, on a [*] basis (unless otherwise requested by the JEC), updates on its activities and achievements to the JEC for review and comment. The Parties intend that their respective organizations will work together to assure the success of the Collaboration.

Role of Committees. Subject to Section 2.1(b) The Parties will establish several committees (each a “Committee” and collectively the “Committees”), as follows: Joint Executive Committee (“JEC”). The JEC shall manage the overall collaboration strategy (including the intellectual property strategy), discuss and approve or reject the recommendations of the JSC and resolve any disputed matter of the JSC. The JEC shall be composed of an equal number of representatives of SERVIER and INTERCEPT. Joint Steering Committee (“JSC”). The JSC shall be composed of an equal number of representatives of SERVIER and INTERCEPT and shall validate and follow-up on the research, development, manufacturing, regulatory and intellectual property strategies and the other terms and conditions approval of this Agreement, the Parties shall establish: recommendations of the corresponding committees. This includes in particular: (i) a joint executive committee (approving criteria for Selected Preclinical Compound proposed by the “Joint Executive Committee” or “JEC”) that will oversee the Collaboration and facilitate communications between the Parties with respect to the Development, Regulatory Approval, and Commercialization of Committee-Governed Products hereunder; and JRDC; (ii) three upon proposal of the JRDC, approving if and when the above criteria have been met for a Compound; (3iii) specialized joint committees consisting upon proposal of one the JRDC, approving the targeted pathology, the population and the expected indications for the Compound; (iv) upon proposal of the JRDC, approving the Pre-Clinical Development Plan and the Clinical Development Plan including the design of the studies, methodologies, the choice of the doses and establishing the main criteria for demonstrating drug efficacy and following their implementation; (v) upon proposal of the JRDC, approving a publication plan for the Compounds and Products; (vi) making recommendations to focus on each the JEC; and (vii) resolving matters in dispute before the JRDC. Joint Research and Development Committee (“JRDC”). The Parties shall establish a Joint Research and Development Committee composed of an equal number of representatives of SERVIER and INTERCEPT. The JRDC shall include members who are competent in some or all of the following areas arising out of disciplines: chemistry, pharmaceutical development pharmacology, safety pharmacology, toxicology, pharmacokinetics (ADME), clinical development and regulatory affairs. The JRDC shall be responsible for developing (subject to JSC approval), overseeing the Collaboration: (A) Development implementation and Regulatory Approval assessing the research and other regulatory matters (such committee, the “Joint Development and Regulatory Committee” or “JDC”); (B) Commercialization (such committee, the “Joint Commercialization Committee” or “JCC”); and (C) financial issues (such committee, the “Joint Finance Committee” or “JFC”). Each Committee shall have the responsibilities and authority allocated to it in this Article 2 and elsewhere in this Agreement. It is contemplated that: (X) all significant matters (other than Party Implementation Matters, as defined in Section 2.6(c)(ii)) relating to the pre-clinical and clinical Development of Committee-Governed Products development activities and the Commercialization of Co-Developed Products, associated budget and in each case under this Agreement will be addressed by the applicable first-tier Committees (i.e., the JDC, the JCC, or the JFC) and, if appropriate, by the JEC, as contemplated by Section 2.6(c); and (Y) the Parties’ respective activities under this Agreement (including Party Implementation Matters) will be reported to the relevant Committees in a reasonable and appropriate level of detail. Each of the JDC, JCC, and the JFC shall provide, on a [*] basis (unless otherwise requested by the JEC), updates on its activities and achievements to the JEC for review and comment. The Parties intend that their respective organizations will work together to assure the success of the Collaboration.particular:

Role of Committees. Subject to Section 2.1(b) 2.1.2 and the other terms and conditions of this Agreement, the Parties shall establish: establish (ia) a joint executive committee (the “Joint Executive Committee” or “JEC”) that will oversee the Collaboration Parties’ activities under this Agreement (the “Collaboration”) and facilitate communications between the Parties with respect to the Development, Regulatory Approval, manufacturing and Commercialization of Committee-Governed the Products hereunder; , and (iib) three four (34) specialized joint committees consisting of one to focus on each of the following areas arising out of the Collaborationareas: (A) Development and Regulatory Approval and other regulatory matters (such committee, the “Joint Development and Regulatory Committee” or “JDC”); (B) , Commercialization (such committee, the “Joint Commercialization Committee” or “JCC”); , manufacturing (such committee, the “Joint Manufacturing Committee” or “JMC”) and (C) financial issues (such committee, the “Joint Finance Financial Committee” or “JFC”), respectively, arising out of the Collaboration. Each Committee shall have the responsibilities and authority allocated to it in this Article 2 and elsewhere in this Agreement. It is contemplated that: that (Xi) all significant matters (other than Party Implementation Matters, as defined in Section 2.6(c)(ii2.7.3(b)) relating to the pre-clinical Development and clinical Development of Committee-Governed Products and the Commercialization of Co-Developed Products, in each case Products under this Agreement will be addressed by the applicable first-first tier Committees (i.e., the JDC, the JCC, the JMC or the JFC) and, if appropriate, by the JEC, as contemplated by Section 2.6(c); 2.7.3, regardless of whether or not Development of an Indication is being fully co-funded by the Parties, whether or not a Product is being Co-Promoted by Medarex or whether or not Medarex retains an option to Co-Promote a Product, and (Yii) the Parties’ respective activities under this Agreement (including Party Implementation Matters) will be reported to the relevant Committees in a reasonable and appropriate level of detail. Each of the JDC, JCC, and the JFC shall provide, on a [*] basis (unless otherwise requested by the JEC), updates on its activities and achievements to the JEC for review and comment. The Parties intend that their respective organizations will work together to assure the success of the Collaboration.

Role of Committees. Subject to Section 2.1(b) and the other terms and conditions of this Agreement, the Parties shall establish: (i) a joint executive committee (the “Joint Executive Committee” or “JEC”) that will oversee the Collaboration and facilitate communications between the Parties with respect to the Development, Regulatory Approval, and Commercialization of Committee-Governed Products hereunder; and (ii) three four (34) specialized joint committees consisting of one to focus on each of the following areas arising out of the Collaboration: (A) discovery efforts in connection with Screening Programs, Lead Op Programs, Provisional Collaboration Programs and Collaboration Programs, as described in Article 3 (such committee, the “Joint Research Committee” or “JRC”); (B) Development and Regulatory Approval and other regulatory matters (such committee, the “Joint Development and Regulatory Committee” or “JDC”); (BC) Commercialization (such committee, the “Joint Commercialization Committee” or “JCC”); and (CD) financial issues (such committee, the “Joint Finance Committee” or “JFC”). Each Committee shall have the responsibilities and authority allocated to it in this Article 2 and elsewhere in this Agreement. It is contemplated that: (X) all significant matters (other than Party Implementation Matters, as defined in Section 2.6(c)(ii2.7(c)(ii)) relating to to: (I) the discovery and pre-clinical Development of Collaboration Compounds; and (II) the clinical Development of Committee-Governed Products and the Commercialization of Co-Developed Promotion Products, in each case under this Agreement will be addressed by the applicable first-tier Committees (i.e., the JRC, the JDC, the JCC, or the JFC) and, if appropriate, by the JEC, as contemplated by Section 2.6(c2.7(c); and (Y) the Parties’ respective activities under this Agreement (including Party Implementation Matters) will be reported to the relevant Committees in a reasonable and appropriate level of detail. Each of the JRC (to the extent applicable), JDC, JCC, and the JFC shall provide, on a [*[ * ] basis (unless otherwise requested by the JEC), updates on its activities and achievements to the JEC for review and comment. The Parties intend that their respective organizations will work together to assure the success of the Collaboration.

Role of Committees. Subject to Section 2.1(b) and the other terms and conditions of this Agreement, the Parties shall establish: (i) a joint executive committee (the “Joint Executive Committee” or “JEC”) that will oversee the Collaboration and facilitate communications between the Parties with respect to the Development, Regulatory Approval, and Commercialization of Committee-Governed Products hereunder; and (ii) three (3) specialized joint committees consisting of one to focus on each of the following areas arising out of the Collaboration: (A) Development and Regulatory Approval and other regulatory matters (such committee, the “Joint Development and Regulatory Committee” or “JDC”); (B) Commercialization (such committee, the “Joint Commercialization Committee” or “JCC”); and (C) financial issues (such committee, the “Joint Finance Committee” or “JFC”). Each Committee shall have the responsibilities and authority allocated to it in this Article 2 and elsewhere in this Agreement. It is contemplated that: (X) all significant matters (other than Party Implementation Matters, as defined in Section 2.6(c)(ii)) relating to the pre-clinical and clinical Development of Committee-Governed Products and the Commercialization of Co-Developed Products, in each case under this Agreement will be addressed by the applicable first-tier Committees (i.e., the JDC, the JCC, or the JFC) and, if appropriate, by the JEC, as contemplated by Section 2.6(c); and (Y) the Parties’ respective activities under this Agreement (including Party Implementation Matters) will be reported to the relevant Committees in a reasonable and appropriate level of detail. Each of the JDC, JCC, and the JFC shall provide, on a [*[ * ] basis (unless otherwise requested by the JEC), updates on its activities and achievements to the JEC for review and comment. The Parties intend that their respective organizations will work together to assure the success of the Collaboration.

Role of Committees. Subject The Parties will establish several committees (each a “Committee” and collectively the “Committees”), as follows: Portions of this Exhibit, indicated by the m▇▇▇ “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to Section 2.1(b) the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. Joint Executive Committee (“JEC”). The JEC shall manage the overall collaboration strategy (including the intellectual property strategy), discuss and approve or reject the recommendations of the JSC and resolve any disputed matter of the JSC. The JEC shall be composed of an equal number of representatives of SERVIER and INTERCEPT. Joint Steering Committee (“JSC”). The JSC shall be composed of an equal number of representatives of SERVIER and INTERCEPT and shall validate and follow-up on the research, development, manufacturing, regulatory and intellectual property strategies and the approval of the recommendations of the corresponding committees. This includes in particular: (i) approving criteria for Selected Preclinical Compound proposed by the JRDC; (ii) upon proposal of the JRDC, approving if and when the above criteria have been met for a Compound; (iii) upon proposal of the JRDC, approving the targeted pathology, the population and the expected indications for the Compound; (iv) upon proposal of the JRDC, approving the Pre-Clinical Development Plan and the Clinical Development Plan including the design of the studies, methodologies, the choice of the doses and establishing the main criteria for demonstrating drug efficacy and following their implementation; (v) upon proposal of the JRDC, approving a publication plan for the Compounds and Products; (vi) making recommendations to the JEC; and (vii) resolving matters in dispute before the JRDC. Joint Research and Development Committee (“JRDC”). The Parties shall establish a Joint Research and Development Committee composed of an equal number of representatives of SERVIER and INTERCEPT. The JRDC shall include members who are competent in some or all of the following disciplines: chemistry, pharmaceutical development pharmacology, safety pharmacology, toxicology, pharmacokinetics (ADME), clinical development and regulatory affairs. The JRDC shall be responsible for developing (subject to JSC approval), overseeing the implementation and assessing the research and development activities and the associated budget and in particular: i. monitoring the progress of the research and development activities; ii. drafting and proposing updates to the Pre-Clinical Development Plan and the Clinical Development Plan for approval (or rejection) by the JSC and implementing it once approved; iii. approving the pharmacological protocols; Portions of this Exhibit, indicated by the m▇▇▇ “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. ▇▇. defining and validating screening strategies; v. designing of the criteria for Selected Preclinical Compound; vi. evaluating if and when the above criteria have been met for a Compound; vii. defining the objectives of the non-clinical studies, their methodology, the choice of the doses; viii. designing of the criteria for non clinical work and evaluating if and when the end-points are met; ix. overseeing the set up of the studies; x. following up on the implementation of the studies; xi. reporting its activities to the JSC; xii. defining the objectives of the Clinical Trials, their methodology, the choice of the doses, the main criteria for evaluating success or failure and the statistical analysis plan; xiii. stipulating the objectives of chemical development (methodology, choice of chemical pathways, specifications and all other terms essential items); xiv. reviewing the protocols and conditions reports for Clinical Trials and non-clinical studies; xv. reviewing the amendments to protocols for Clinical Trials and non-clinical studies; xvi. overseeing the set up of Clinical Trials and non-clinical studies, and reviewing their progress, follow-up and results; xvii. reviewing the studies’ specifications to ensure in particular the consistency of the clinical and non-clinical databases generated by or on behalf of the Parties with the Regulatory Authority requirements in the EU and in the USA; xviii. defining the way the results of the Clinical Trials and non-clinical studies will be publicly disclosed, in accordance with all applicable laws and Parties’ specific internal procedures; xix. reviewing the investigator brochures, product labels and package inserts; and xx. discussing and controlling the prosecution and maintenance of the patents in accordance with article 5.2 of this Agreement. Portions of this Exhibit, indicated by the m▇▇▇ “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. Notwithstanding the tasks assigned to the JRDC, it is the intention of the Parties that nothing in this Agreement shall require the performance of the activities described in the Pre-Clinical Development Plan and in the Clinical Development Plan in a manner that would result in SERVIER being subjected to the jurisdiction of the courts of the USA or any of its territories or possessions. In the event that SERVIER reasonably determines that performance of its obligations under Pre-Clinical Development Plan or the Clinical Development Plan in accordance with this Agreement would subject SERVIER to such jurisdiction, then the Parties shall establish: (i) meet to discuss an alternative approach to the conduct of such activities in a joint executive committee (manner that avoids the “Joint Executive Committee” or “JEC”) creation of such jurisdiction but that will oversee preserves, insofar as reasonably practicable, the Collaboration rights and facilitate communications between obligations of the Parties hereunder with respect to the Development, Regulatory Approval, and Commercialization of Committee-Governed Products hereunder; and (ii) three (3) specialized joint committees consisting of one to focus on each of the following areas arising out of the Collaboration: (A) Development and Regulatory Approval and other regulatory matters (such committee, the “Joint Development and Regulatory Committee” or “JDC”); (B) Commercialization (such committee, the “Joint Commercialization Committee” or “JCC”); and (C) financial issues (such committee, the “Joint Finance Committee” or “JFC”)activities. Each Committee shall have the responsibilities and authority allocated to it in this Article 2 and elsewhere in this Agreement. It is contemplated that: (X) all significant matters (other than Party Implementation Matters, as defined in Section 2.6(c)(ii)) relating to the pre-clinical and clinical Development of Committee-Governed Products and the Commercialization of Co-Developed Products, in each case under this Agreement will be addressed by the applicable first-tier Committees (i.e., the JDC, the JCC, or the JFC) andThe JRDC may appoint, if appropriateand when needed, by the JECsub-committees on specific matters such as marketing, as contemplated by Section 2.6(c); intellectual property and (Y) the Parties’ respective activities under this Agreement (including Party Implementation Matters) will be reported to the relevant Committees in a reasonable and appropriate level of detail. Each of the JDC, JCC, and the JFC shall provide, on a [*] basis (unless otherwise requested by the JEC), updates on its activities and achievements to the JEC for review and comment. The Parties intend that their respective organizations will work together to assure the success of the Collaborationmanufacturing.