Specific Responsibilities of the JDC Sample Clauses
Specific Responsibilities of the JDC. In addition to its general responsibilities, the JDC shall in particular:
(i) Manage and oversee the preparation and implementation of the Development Plan;
(ii) Review, discuss and approve non-material amendments to the Development Plan;
(iii) Every [***] months, review, discuss, amend, update and submit to the JSC for approval: the Development Plan (subject to Section 3.6), including the Joint Development Budget, the TPP, and any material amendments thereto; review and discuss proposals for new Development Activities pursuant to Section 3.5 and seek input from the JCC;
(iv) Decide upon which Party will be responsible for the performance of the various activities set forth in the Development Plan on the basis of each Party’s respective experience, capabilities and capacity as set forth in Section 3.11, including which Party will be the Sponsor of a new Global Trial that is a Joint Development Activity;
(v) Oversee the conduct and progress of all Trials required as set forth in the Development Plan, including compliance with Laws and applicable GLP, GCP and/or GMP standards, mitigation actions, e.g. clinical Trial liaison activities and medical scientific activities, in order to improve Trial recruitment and Trial site engagement and any Development Activities;
(vi) Align with the Medical Affairs function with regards to Early Access Programs and investigator initiated Trials;
(vii) Review and discuss the progress of any Sole Funded Development Activity;
(viii) Coordinate and facilitate the exchange of information between the Parties under this Agreement regarding the strategy for implementing the Development Activities, including sharing and reviewing of Development Data created pursuant to this Agreement and establishing procedures for the efficient and prompt sharing of information and materials and Know-How reasonably necessary or useful for the Development of the Product in the Territory;
(ix) Coordinate and facilitate exchange by both Parties of Regulatory Data and Regulatory Materials in support of filings, facility inspections and Product launch in the Co-Commercialization Territory and the COMPANY Territory; review, discuss and, with respect to Joint Development Activities only, approve the design of the Trial protocols and endpoints;
(x) Discuss and agree on the regulatory strategy for filing and maintaining Regulatory Approvals in the Co-Commercialization Territory, in alignment with the JCC;
(xi) Review and discuss the regulatory strategy for f...
Specific Responsibilities of the JDC. In addition to its overall responsibilities described in Section 2.2.1, subject to Section 2.6.1, the JDC shall, in particular:
(a) select Collaboration Products for research and Development under this Agreement in the US Territory and Major EU Markets;
(b) prepare, approve and amend each Development Plan (including regulatory submission strategies and plans) for Collaboration Products in the Major EU Markets;
(c) monitor the progress of the activities undertaken by the Parties pursuant to each Development Plan;
(d) review and approve proposals from the Parties to Develop Improvements and/or Combination Products;
(e) coordinate and oversee the Parties’ Regulatory Approval submission plans in the US Territory;
(f) design and approve all clinical trials of Collaboration Products proposed to be conducted anywhere in the world for consistency and efficiency, including without limitation by creating the protocols, defining the end points, and selecting the primary investigators for such trials;
(g) have primary responsibility for establishing the objectives for all Phase IV Clinical Trials of Collaboration Products proposed to be conducted for the US Territory, including without limitation by creating the protocols, defining the end points, and selecting the primary investigators for such trials;
(h) manage the flow of information with respect to Development being conducted for each Collaboration Product;
(i) review and approve the statistical analysis plans and protocols for all Collaboration Product clinical studies conducted worldwide, and any investigator’s brochure(s) and revisions thereto;
(j) work together with the other Committees during the Development of Collaboration Products to assure a smooth transition from Development of such Collaboration Product to Commercialization of such Collaboration Product;
(k) review and approve compliance plans whereby the Parties prepare for or participate in a Governmental Authority inspection of the preclinical or clinical data or preclinical sites/clinical sites or laboratories; and
(l) review and approve pharmacovigilance plans.
Specific Responsibilities of the JDC. The JDC has the following responsibilities:
2.4.2.1. oversee and review Development responsibilities for each Regional Antibody Candidate and Regional Licensed Product; CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
2.4.2.2. discuss, prepare and approve for submission to the JSC all RLP Development Plans, and all amendments to RLP Development Plans for Regional Antibody Candidates and Regional Licensed Products;
2.4.2.3. oversee the conduct of all RLP Development Plans;
2.4.2.4. create, implement and review the overall strategy for Development, including the design of all Clinical Studies for Regional Antibody Candidates and Regional Licensed Products, conducted under the RLP Development Plans, as applicable;
2.4.2.5. decide whether and when to initiate or discontinue any Clinical Study for any Regional Antibody Candidate or Regional Licensed Product under each RLP Development Plan, as applicable, provided that nothing is intended to limit a Party’s ability to comply with applicable Law or manage subject safety;
2.4.2.6. allocate budgeted resources and determine priorities for each Clinical Study for Regional Antibody Candidates and Regional Licensed Products included under each RLP Development Plan;
2.4.2.7. oversee the conduct of all Clinical Studies for Regional Antibody Candidates and Regional Licensed Products included under each RLP Development Plan;
2.4.2.8. facilitate the flow of information between the Parties with respect to the Development of T1 Antibody Candidates, T1 Licensed Products, Regional Antibody Candidates, Regional Licensed Products, Global Antibody Candidates or Global Licensed Products;
2.4.2.9. allocate primary responsibility as between the Parties for tasks relating to the Development of Regional Antibody Candidates where not already specified in the RLP Development Plans therefor;
2.4.2.10. review, discuss and oversee Manufacturing for the Development of Regional Antibody Candidates and Regional Licensed Products, including the supply chain for Regional Antibody Candidates and Regional Licensed Products; CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FI...
Specific Responsibilities of the JDC. In support of its responsibility for overseeing, coordinating and expediting the Development of, and regulatory filings for, each Product, but subject to Sections 2.1(b) and 2.4(c), the JDC shall, in particular:
(i) monitor Development activities;
(ii) review and approve the Global Development Plans and Annual Development Plans prepared by BMS with input from key PDL clinical development personnel, as well as interim updates to such plans;
(iii) review all material information generated in the course of implementing the Global Development Plan and the Annual Development Plans;
(iv) assist in coordinating scientific interactions and division of responsibilities with respect to Development Activities, and resolving disagreements during the course of implementing the Global Development Plan and the Annual Development Plans;
(v) review and determine whether, and when, to obtain any licenses to intellectual property necessary or reasonably useful for the Development, Commercialization or Manufacture of a Product, other than as set forth in Section 7.7;
(vi) design, in collaboration with the USJCC, pharmacoeconomic studies or Phase IV Clinical Trials;
(vii) discuss all regulatory plans, communications and submissions for Products, including the schedule and implementation strategy for all regulatory filings for Products, it being understood that BMS shall have responsibility for preparing and submitting DAAs and for seeking all Regulatory Approvals; * Certain information on this page has been omitted and filed separately with the SEC. Confidential treatment has been requested with respect to the omitted portions.
(viii) discuss BMS’ plans and activities for the life cycle management of, and co-ordinate with respect to the intellectual property protection for, a Product;
(ix) provide an initial forum for dispute resolution; and
(x) such other responsibilities as may be assigned to the JDC pursuant to the Agreement or as may be agreed between the Parties from time to time.
Specific Responsibilities of the JDC. In addition to its general responsibilities set forth in Section 5.2.1, the JDC shall, in particular, have responsibility for:
(a) facilitating cooperation and coordination between the Parties regarding Development matters;
(b) preparing and proposing, for JSC approval, amendments to the then-current Development Plan and the corresponding Development budget and proposing such Development Plan and Development budget for approval by the JSC. Any amended Development Plan shall cover the next Calendar Year (and additional periods as reasonably determined by the Parties) and shall contain a corresponding Development budget;
(c) monitoring, reviewing, coordinating, and discussing the overall progress of Development under this Agreement;
(d) facilitating the flow of information with respect to Development activities being conducted for Products in or for the Territory, including through the review of data, reports, or other information submitted by either Party with respect to Development activities conducted by or on behalf of such Party;
(e) assigning lead parties for specific tasks or activities identified in the Development Plan;
(f) reviewing, discussing and proposing appropriate Third Party subcontractors to engage for the purpose of supporting the Development activities to be carried out by each of the Parties;
(g) coordinating communications by the Parties with the Regulatory Authorities with respect to Products in accordance with this Agreement; and
(h) reviewing, coordinating, discussing and proposing the overall strategy for Regulatory Filings for approval by the JSC, except to the extent impracticable with respect to expedited safety reports.
Specific Responsibilities of the JDC. The responsibilities of the JDC will be to:
Specific Responsibilities of the JDC. Each JDC shall oversee Development of the applicable Product Candidate under the Product Development Program. In particular, such JDC shall: [***].
Specific Responsibilities of the JDC. In support of its responsibility for overseeing, coordinating and expediting the Development of, and regulatory filings for, each Committee-Governed Product, but subject to Sections 2.1(b) and 2.7(c), the JDC shall, in particular, and solely with respect to Committee Governed Products:
(i) monitor Development activities;
(ii) prepare the Global Development Plan and each Annual Development Plan;
(iii) review all material information generated in the course of implementing the Global Development Plan and the Annual Development Plans;
(iv) assist in coordinating scientific interactions and division of responsibilities with respect to Development Activities, and resolving disagreements during the course of implementing the Global Development Plan and the Annual Development Plans;
(v) design, in collaboration with the JCC, pharmacoeconomic studies or Phase IV Clinical Trials;
(vi) monitor and coordinate all regulatory actions, communications and submissions for Products, including establishing the schedule and implementation strategy for all regulatory filings for Products;
(vii) provide on a quarterly basis updates on its activities and achievements to the JEC for review and comment;
(viii) pursuant to Section 3.6(b), review and determine whether the definition of Identified Target(s) for each applicable Lead Op Program, Provisional Collaboration Program and Collaboration Program need to be modified; and
(ix) such other responsibilities as may be assigned to the JDC pursuant to the Agreement or as may be agreed between the Parties from time to time.
Specific Responsibilities of the JDC. In addition to its general responsibility to manage, monitor, review and coordinate the development and Regulatory Approval of the Product in the Territory according to the Development Plans and to ensure a regular flow of development information among the Parties, the JDC shall in particular:
(i) revise each draft Development Plan prepared by the Parties and present the revised draft Development Plan to the CSC, all in accordance with Sections 4.2 and 4.3;
(ii) review, coordinate and approve all plans for clinical, manufacturing and radiolabeling activities with respect to the Product in or for the Territory;
(iii) facilitate the flow of information between the Parties with respect to all development of the Product for and in the Territory;
(iv) establish the levels of supply of Product needed for the Initial Approval Clinical Trials as provided in Section 4.5 and for Subsequent Clinical Trials; and
(v) perform any other responsibilities set forth for the JDC in this Agreement.
Specific Responsibilities of the JDC. In addition to its general responsibilities, the JDC shall, subject to the terms of this Agreement, in particular: