Role of Committees. The Parties will establish several committees (each a “Committee” and collectively the “Committees”), as follows: Portions of this Exhibit, indicated by the mxxx “[***],” 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. 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 mxxx “[***],” 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. xx. 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 essential items); xiv. reviewing the protocols and 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 mxxx “[***],” 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 meet to discuss an alternative approach to the conduct of such activities in a manner that avoids the creation of such jurisdiction but that preserves, insofar as reasonably practicable, the rights and obligations of the Parties hereunder with respect to such activities. The JRDC may appoint, if and when needed, sub-committees on specific matters such as marketing, intellectual property and manufacturing.
Appears in 1 contract
Role of Committees. The Subject to Section 2.1(b) and the other terms and conditions of this Agreement, the Parties will establish several committees shall establish: (each i) a joint executive committee (the “Joint Executive Committee” and collectively the “Committees”), as follows: Portions of this Exhibit, indicated by the mxxx “[***],” 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. Joint Executive Committee (or “JEC”). The JEC shall manage ) that will oversee the overall collaboration strategy Collaboration and facilitate communications between the Parties with respect to the Development, Regulatory Approval, and Commercialization of Committee-Governed Products hereunder; and (including the intellectual property strategy), discuss and approve or reject the recommendations ii) three (3) specialized joint committees consisting of one to focus on each of the JSC and resolve any disputed matter following areas arising out of the JSC. The JEC shall be composed of an equal number of representatives of SERVIER Collaboration: (A) Development and INTERCEPT. Regulatory Approval and other regulatory matters (such committee, the “Joint Steering Committee Development and Regulatory Committee” or “JDC”); (B) Commercialization (such committee, the “JSCJoint Commercialization Committee” or “JCC”); and (C) financial issues (such committee, the “Joint Finance Committee” or “JFC”). The JSC Each Committee shall be composed 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 an equal number of representatives of SERVIER and INTERCEPT and shall validate and followCommittee-up on the research, development, manufacturing, regulatory and intellectual property strategies Governed Products and the approval 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 recommendations of JDC, JCC, and the corresponding committees. This includes in particular:
JFC shall provide, on a [*] basis (i) approving criteria for Selected Preclinical Compound proposed unless otherwise requested by the JRDC;
(ii) upon proposal of the JRDCJEC), approving if updates on its activities 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 achievements to the JEC; and
(vii) resolving matters in dispute before the JRDC. Joint Research JEC for review and Development Committee (“JRDC”)comment. 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 intend that their respective organizations will work together to assure the success 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 mxxx “[***],” 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 amendedCollaboration.
xx. 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 essential items);
xiv. reviewing the protocols and 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 mxxx “[***],” 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 meet to discuss an alternative approach to the conduct of such activities in a manner that avoids the creation of such jurisdiction but that preserves, insofar as reasonably practicable, the rights and obligations of the Parties hereunder with respect to such activities. The JRDC may appoint, if and when needed, sub-committees on specific matters such as marketing, intellectual property and manufacturing.
Appears in 1 contract
Role of Committees. The Subject to Section 2.1(b) and the other terms and conditions of this Agreement, the Parties will establish several committees shall establish: (each i) a joint executive committee (the “Joint Executive Committee” and collectively the “Committees”), as follows: Portions of this Exhibit, indicated by the mxxx “[***],” 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. Joint Executive Committee (or “JEC”). The JEC shall manage ) that will oversee the overall collaboration strategy Collaboration and facilitate communications between the Parties with respect to the Development, Regulatory Approval, and Commercialization of Committee-Governed Products hereunder; and (including the intellectual property strategy), discuss and approve or reject the recommendations ii) four (4) specialized joint committees consisting of one to focus on each of the JSC and resolve any disputed matter following areas arising out of the JSC. The JEC shall be composed of an equal number of representatives of SERVIER Collaboration: (A) discovery efforts in connection with Screening Programs, Lead Op Programs, Provisional Collaboration Programs and INTERCEPT. Collaboration Programs, as described in Article 3 (such committee, the “Joint Steering Committee Research Committee” or “JRC”); (B) Development and Regulatory Approval and other regulatory matters (such committee, the “JSCJoint Development and Regulatory Committee” or “JDC”); (C) Commercialization (such committee, the “Joint Commercialization Committee” or “JCC”); and (D) financial issues (such committee, the “Joint Finance Committee” or “JFC”). The JSC Each Committee shall be composed 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 2.7(c)(ii)) relating to: (I) the discovery and pre-clinical Development of an equal number Collaboration Compounds; and (II) the clinical Development of representatives of SERVIER and INTERCEPT and shall validate and followCommittee-up on the research, development, manufacturing, regulatory and intellectual property strategies Governed Products and the approval Commercialization of Co-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 2.7(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 recommendations of JRC (to the corresponding committees. This includes in particular:
extent applicable), JDC, JCC, and the JFC shall provide, on a [*] basis (i) approving criteria for Selected Preclinical Compound proposed unless otherwise requested by the JRDC;
(ii) upon proposal of the JRDCJEC), approving if updates on its activities 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 achievements to the JEC; and
(vii) resolving matters in dispute before the JRDC. Joint Research JEC for review and Development Committee (“JRDC”)comment. 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 intend that their respective organizations will work together to assure the success 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 mxxx “[***],” 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 amendedCollaboration.
xx. 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 essential items);
xiv. reviewing the protocols and 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 mxxx “[***],” 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 meet to discuss an alternative approach to the conduct of such activities in a manner that avoids the creation of such jurisdiction but that preserves, insofar as reasonably practicable, the rights and obligations of the Parties hereunder with respect to such activities. The JRDC may appoint, if and when needed, sub-committees on specific matters such as marketing, intellectual property and manufacturing.
Appears in 1 contract
Role of Committees. The Parties will establish several committees (each a “Committee” and collectively the “Committees”), as follows: Portions of this Exhibit, indicated by the mxxx “[***],” 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. 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 mxxx “[***],” 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.
xx. 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 essential items);
xiv. reviewing the protocols and 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 mxxx “[***],” 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 meet to discuss an alternative approach to the conduct of such activities in a manner that avoids the creation of such jurisdiction but that preserves, insofar as reasonably practicable, the rights and obligations of the Parties hereunder with respect to such activities. The JRDC may appoint, if and when needed, sub-committees on specific matters such as marketing, intellectual property and manufacturing.
Appears in 1 contract
Role of Committees. The Subject to Section 2.1.2 and the other terms and conditions of this Agreement, the Parties will shall establish several committees (each a) a joint executive committee (the “Joint Executive Committee” and collectively or “JEC”) that will oversee the Parties’ activities under this Agreement (the “CommitteesCollaboration”) and facilitate communications between the Parties with respect to the Development, Approval, manufacturing and Commercialization of the Products hereunder, and (b) four (4) specialized joint committees consisting of one to focus on each of the following areas: Development and Approval and other regulatory matters (such committee, the “Joint Development and Regulatory Committee” or “JDC”), as follows: Portions of this ExhibitCommercialization (such committee, indicated by the mxxx “[***],Joint Commercialization Committee” were omitted or “JCC”), manufacturing (such committee, the “Joint Manufacturing Committee” or “JMC”) and have been filed separately with financial issues (such committee, the Secretary “Joint Financial Committee” or “JFC”), respectively, arising out of the Commission pursuant Collaboration. Each Committee shall have the responsibilities and authority allocated to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amendedit in this Article 2 and elsewhere in this Agreement. 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:
It is contemplated that (i) approving criteria for Selected Preclinical Compound proposed all significant matters (other than Party Implementation Matters, as defined in Section 2.7.3(b)) relating to the Development and Commercialization of Products under this Agreement will be addressed by the JRDC;
applicable first tier Committees (i.e., the JDC, the JCC, the JMC or the JFC) and, if appropriate, by the JEC, as contemplated by Section 2.7.3, 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 (ii) upon proposal of the JRDC, approving if and when the above criteria have been met for a Compound;
Parties’ respective activities under this Agreement (iiiincluding Party Implementation Matters) 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 will be reported to the JEC; and
(vii) resolving matters relevant Committees in dispute before the JRDC. Joint Research a reasonable and Development Committee (“JRDC”)appropriate level of detail. 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 intend that their respective organizations will work together to assure the success 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 mxxx “[***],” 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 amendedCollaboration.
xx. 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 essential items);
xiv. reviewing the protocols and 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 mxxx “[***],” 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 meet to discuss an alternative approach to the conduct of such activities in a manner that avoids the creation of such jurisdiction but that preserves, insofar as reasonably practicable, the rights and obligations of the Parties hereunder with respect to such activities. The JRDC may appoint, if and when needed, sub-committees on specific matters such as marketing, intellectual property and manufacturing.
Appears in 1 contract
Samples: Collaboration and Co Promotion Agreement (Medarex Inc)
Role of Committees. The Subject to Section 2.1(b) and the other terms and conditions of this Agreement, the Parties will establish several committees shall establish: (each i) a joint executive committee (the “Joint Executive Committee” and collectively the “Committees”), as follows: Portions of this Exhibit, indicated by the mxxx “[***],” 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. Joint Executive Committee (or “JEC”). The JEC shall manage ) that will oversee the overall collaboration strategy Collaboration and facilitate communications between the Parties with respect to the Development, Regulatory Approval, and Commercialization of Committee-Governed Products hereunder; and (including the intellectual property strategy), discuss and approve or reject the recommendations ii) three (3) specialized joint committees consisting of one to focus on each of the JSC and resolve any disputed matter following areas arising out of the JSC. The JEC shall be composed of an equal number of representatives of SERVIER Collaboration: (A) Development and INTERCEPT. Regulatory Approval and other regulatory matters (such committee, the “Joint Steering Committee Development and Regulatory Committee” or “JDC”); (B) Commercialization (such committee, the “JSCJoint Commercialization Committee” or “JCC”); and (C) financial issues (such committee, the “Joint Finance Committee” or “JFC”). The JSC Each Committee shall be composed 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 an equal number of representatives of SERVIER and INTERCEPT and shall validate and followCommittee-up on the research, development, manufacturing, regulatory and intellectual property strategies Governed Products and the approval 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 recommendations of JDC, JCC, and the corresponding committees. This includes in particular:
JFC shall provide, on a [ * ] basis (i) approving criteria for Selected Preclinical Compound proposed unless otherwise requested by the JRDC;
(ii) upon proposal of the JRDCJEC), approving if updates on its activities 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 achievements to the JEC; and
(vii) resolving matters in dispute before the JRDC. Joint Research JEC for review and Development Committee (“JRDC”)comment. 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 intend that their respective organizations will work together to assure the success 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 mxxx “[***],” 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 amendedCollaboration.
xx. 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 essential items);
xiv. reviewing the protocols and 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 mxxx “[***],” 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 meet to discuss an alternative approach to the conduct of such activities in a manner that avoids the creation of such jurisdiction but that preserves, insofar as reasonably practicable, the rights and obligations of the Parties hereunder with respect to such activities. The JRDC may appoint, if and when needed, sub-committees on specific matters such as marketing, intellectual property and manufacturing.
Appears in 1 contract
Role of Committees. The Subject to Section 2.1(b) and the other terms and conditions of this Agreement, the Parties will establish several committees shall establish: (each i) a joint executive committee (the “Joint Executive Committee” and collectively the “Committees”), as follows: Portions of this Exhibit, indicated by the mxxx “[***],” 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. Joint Executive Committee (or “JEC”). The JEC shall manage ) that will oversee the overall collaboration strategy Collaboration and facilitate communications between the Parties with respect to the Development, Regulatory Approval, and Commercialization of Committee-Governed Products hereunder; and (including the intellectual property strategy), discuss and approve or reject the recommendations ii) four (4) specialized joint committees consisting of one to focus on each of the JSC and resolve any disputed matter following areas arising out of the JSC. The JEC shall be composed of an equal number of representatives of SERVIER Collaboration: (A) discovery efforts in connection with Screening Programs, Lead Op Programs, Provisional Collaboration Programs and INTERCEPT. Collaboration Programs, as described in Article 3 (such committee, the “Joint Steering Committee Research Committee” or “JRC”); (B) Development and Regulatory Approval and other regulatory matters (such committee, the “JSCJoint Development and Regulatory Committee” or “JDC”); (C) Commercialization (such committee, the “Joint Commercialization Committee” or “JCC”); and (D) financial issues (such committee, the “Joint Finance Committee” or “JFC”). The JSC Each Committee shall be composed 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 2.7(c)(ii)) relating to: (I) the discovery and pre-clinical Development of an equal number Collaboration Compounds; and (II) the clinical Development of representatives of SERVIER and INTERCEPT and shall validate and followCommittee-up on the research, development, manufacturing, regulatory and intellectual property strategies Governed Products and the approval Commercialization of Co-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 2.7(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 recommendations of JRC (to the corresponding committees. This includes in particular:
extent applicable), JDC, JCC, and the JFC shall provide, on a [ * ] basis (i) approving criteria for Selected Preclinical Compound proposed unless otherwise requested by the JRDC;
(ii) upon proposal of the JRDCJEC), approving if updates on its activities 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 achievements to the JEC; and
(vii) resolving matters in dispute before the JRDC. Joint Research JEC for review and Development Committee (“JRDC”)comment. 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 intend that their respective organizations will work together to assure the success 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 mxxx “[***],” 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 amendedCollaboration.
xx. 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 essential items);
xiv. reviewing the protocols and 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 mxxx “[***],” 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 meet to discuss an alternative approach to the conduct of such activities in a manner that avoids the creation of such jurisdiction but that preserves, insofar as reasonably practicable, the rights and obligations of the Parties hereunder with respect to such activities. The JRDC may appoint, if and when needed, sub-committees on specific matters such as marketing, intellectual property and manufacturing.
Appears in 1 contract
