3Responsibilities Clause Samples
3Responsibilities. The Core Team shall (i) develop and maintain the Project Plan and monitor, review and manage the Service according to the MSA and applicable PSA; (ii) conduct project stage reviews with the JSC as required by the Project Plan at appropriate milestones or completion of key deliverables or a sequence of event to review key deliverables, review its progress and performance against plans; (iii) develop a change management process to identify, review and recommend any significant changes in the project scope, time, fee or risk to the JSC; (iv) investigate and resolve business, manufacturing, supply chain, quality, regulatory or other issues arising during the Service; (v) review and escalate to the JSC, as needed, changes to the Project Plan or applicable QAG; (vi) review and recommend to the JSC changes to the Specifications, analytical methods, the Manufacturing Process, the Facility or equipment; (vii) coordinate the activities of the Parties relating to the Manufacturing hereunder, including but not limited to: managing the technical operations and quality aspects of routine manufacturing, conducting Product testing technical operations and quality aspects of routine manufacturing, conducting Product testing and release, and managing supply chain activities including shipping and delivery logistics; (viii) report periodically on operation and quality progress and performance; and (ix) perform such other tasks and undertake such other responsibilities as may be specifically delegate to the Core Team by mutual agreement of the Parties. For the avoidance of doubt, the Core Team shall be without authority to make decisions not otherwise concurred in by the Parties.
3Responsibilities. With respect to each country in the Territory, the Lead Regulatory Party shall, in accordance with the Global Regulatory Plan, Party Regulatory Plan (if applicable), and the terms and conditions of this Agreement: (a) be responsible for the day-to-day implementation of the regulatory activities required to obtain and maintain Regulatory Approval of the Product in the applicable country (provided that any decision to file a DAA for the Product anywhere in the Territory must be approved by the JSC); (b) subject to consistency with the Core Data Sheet, be responsible for labeling of the Product in the applicable country for which it is the Lead Regulatory Party; (c) take the lead with respect to communications with the Regulatory Authorities in such country; and (d) designate a representative to serve as the designated regulatory official for the Product in such country for purposes of receiving and delivering communications from the Regulatory Authorities in such country. The other Party will cooperate with the Lead Regulatory Party as reasonably necessary, and solely with respect to the Major Markets, the costs thereof will be Development Costs.
3Responsibilities. Except as otherwise set forth in this Section 3.2, the JSC may perform the following functions, subject to the final decision-making authority as set forth in Section 3.2.4:
(a) oversee, review, monitor progress of, and guide the strategic direction of the Collaboration, including the Research Program and the Programs in accordance with this Agreement;
(b) serve as a forum for exchanging information and facilitating discussions regarding the conduct of the Collaboration, including by facilitating discussions between the Parties regarding the identification and evaluation of Collaboration Bispecific Antibodies and Collaboration Targets;
(c) [*];
(d) prioritize the Research Program with respect to particular Collaboration Bispecific Antibodies and determine which Party’s capabilities and infrastructure should be utilized in such Research Program;
(e) designate a Back-Up Bispecific Antibody for inclusion in the same Program as an Optimized Bispecific Antibody;
(f) determine the Joint Clinical Candidate Criteria and any amendments to the Joint Clinical Candidate Criteria;
(g) review and discuss Evaluated Bispecific Antibodies, including with respect to a Joint Program, if any Optimized Bispecific Antibody satisfies the Joint Clinical Candidate Criteria;
(h) approve and designate Optimized Bispecific Antibodies nominated by the JDC for each Joint Program as a Joint Clinical Candidate;
(i) for each Joint Bispecific Antibody and/or Joint Product, review and approve the Joint Development Plan and Joint Development Budget, and any modifications thereto resulting in expenditures over [*] of the then-existing and approved Joint Development Plan and Joint Development Budget, as well as any new Clinical Trials or indications proposed for such Joint Bispecific Antibody or Joint Product;
(j) serve as a forum for each Party to communicate at certain points in time its decisions regarding continuation of its participation in the joint Development of each Joint Bispecific Antibody and/or Joint Product;
(k) discuss and attempt to resolve any disputes in any Subcommittees, including the issues escalated to the JSC by the JRC, JDC, or JCC; and
(l) perform such other responsibilities as may be mutually agreed to by the Parties from time to time. For purposes of clarity, the JSC shall not have any authority beyond the specific matters set forth in this Section 3.2.3 or otherwise expressly set forth in this Agreement, and in particular shall not have any power to amend, m...