Functions and Authority. The Joint Manufacturing Committee shall have responsibility for the following:
(1) facilitating the exchange of information between the Parties, and coordinating resolution of issues relevant to the Manufacturing and supply of Licensed Products during the Term;
(2) agreeing upon and documenting an overall Licensed Products Manufacturing strategy to ensure reliable and timely supply for Development and Commercialization by each Party hereunder;
(3) planning and coordinating Licensed Products Manufacturing activities and supply, including process development, technology transfer, audits, inspections, manufacturing scale-up and material decisions under CMO agreements;
(4) developing and recommending for review and approval by the Joint Steering Committee, as applicable and subject to Article 6, the Global Manufacturing Plan, and any amendments or revisions thereto, and developing and approving, as applicable and subject to Article 6, the Technical Transfer Plan, the XMT-1519 Technical Transfer Plan, and any amendments or revisions thereto;
(5) selecting which Party shall be responsible for fill and finish of Licensed Products in the First Supply Chain;
(6) planning and coordinating the establishment of the First Supply Chain and Second Supply Chain by the Parties in accordance with the Global Manufacturing Plan;
(7) reviewing, commenting on, and recommending for review and approval by the Joint Steering Committee, as applicable, any amendments or revisions to the Global Development Plan that relate to Manufacturing or supply of Licensed Products including manufacturing scale-up;
(8) reviewing, commenting on and approving major changes regarding the supply chain(s) for Licensed Product(s), including selection of CMOs that would perform Licensed Product or Component Manufacturing in accordance with Good Manufacturing Practices (each such CMO so approved by the Joint Manufacturing Committee, an “Approved CMO”) and changes to facility locations;
(9) reviewing, commenting on and approving changes to the Manufacturing process for each Licensed Product and Component (including changes relating to the drug product and to the conjugation step); and
(10) such other responsibilities as may be assigned to the Joint Manufacturing Committee pursuant to this Agreement or otherwise mutually agreed upon by the Parties in writing from time to time.
Functions and Authority. The JSC will be responsible for overseeing the Research Collaboration and the Research Programs, Phase I Clinical Trials, Phase I/II Clinical Trials, and Phase II Clinical Trials (for so long as Codiak or its Affiliates are conducting such trials), and any Development after the exercise by Codiak of its Development and Commercialization Option, and will oversee the activities under the Co-Promotion Agreement(s), if applicable, as set forth below. Its functions (which may be delegated to any subcommittees) include:
i. Oversee the conduct of the Research Programs, the EDPs and the JDPs, including reviewing any expected or actual delays in the conduct of the activities thereunder;
ii. Oversee the commencement of IND-Enabling Studies and designation of Development Candidates;
iii. Oversee development of regulatory strategies for the Licensed Compounds and Licensed Products;
iv. Review and approve Work Plans (subject to Section 2.3), EDPs, JDPs, and Shared Territory Commercialization Plans and, to the extent applicable, corresponding budgets and amendments to any of the foregoing, including in connection with Schedule 4.3.3;
v. As contemplated in Section 2.4 and Section 4.6, approve subcontractors, decide which types of subcontractor agreements do not require review, and otherwise consider ways to streamline review of subcontracting;
vi. Coordinate the Manufacturing activities and technology transfer activities of Codiak and its Affiliates and Jazz and its Affiliates hereunder and under any supply agreement entered into by the Parties or their respective Affiliates;
vii. Facilitate the flow of information between the Parties regarding Development, and the transfer of Codiak Know-How and Research Program Materials in accordance with the applicable Work Plan;
viii. Resolve issues referred to the JSC by the Alliance Managers or any subcommittee created by the JSC;
ix. Review reports received from either Party as contemplated herein;
x. Coordinate the logistics of the Parties’ financial reporting obligations;
xi. Following exercise of the Development and Commercialization Option, review and discuss Jazz’s reports and updates to the JSC regarding its Commercialization activities and plans for Licensed Products in the Shared Territory;
xii. Following exercise of the Development and Commercialization Option, (1) review and update financial forecasts at least quarterly to ensure actual and anticipated spend is within the approved Commercial Budget; and (2) to the exten...
Functions and Authority. The Project Leaders will be responsible for supervising and managing the Research Programs. Their functions will be:
(a) Overseeing and coordinating the progress, timelines, budget and results of the Research Programs;
(b) Reviewing and approving each Research Plan (including the budget therein) and any proposed amendments to the Research Plans proposed pursuant to Section 2.2.4, provided that the Research Plan (including the budget therein) for the first and second Designated Targets attached hereto as Schedule 2.2.3-1 shall be deemed approved by the Project Leaders;
(c) Reviewing each Party’s reports regarding its activities under each Research Plan;
(d) Deciding whether it is scientifically or technically feasible to create an ADC Directed to the applicable Designated Target in accordance with each Research Plan;
(e) Deciding whether an ADC meets the applicable Performance Specifications set forth in each Research Plan;
(f) Approval of and any changes to the Strategic IP Plan proposed by the JIPC.
(g) Resolving any disputes delegated to the Project Leaders by the JPT or the JIPC;
(h) Overseeing the activities conducted pursuant to each Supply Agreement; and
(i) Such other matters as the Parties may mutually agree in writing.
Functions and Authority. During the Term the JIPC shall:
(a) for each Research Program, draft and propose a Strategic IP Plan (and any amendments thereto) to the Project Leaders, which Strategic IP Plan at a minimum needs to detail the countries of filing and a patent filing strategy, which strategy shall (1) be aligned between the Parties to secure the maximum protection of Product Technology and Mersana Platform Technology, (2) [***] and (3) include that any proposed filing of a Mersana Platform Patent Right [***];
(b) oversee the drafting, filing, prosecution and maintenance of all Patent Rights generated from the activities under this Agreement in accordance with the Strategic IP Plan and Section 8, which shall include overseeing Mersana’s reasonable opportunity to comment on all [***] Patent Right filings and Merck’s obligation to reasonably consider in good faith Mersana’s comments with respect thereto;
(c) as necessary, take day-to-day decisions relating to the drafting, filing, prosecution and maintenance of the resulting Patent Rights in accordance with the Strategic IP Plan and Section 8;
(d) report to the Project Leaders on the drafting, filing, prosecution and maintenance of such Patent Rights;
(e) propose to the Project Leaders any changes or additions to the Strategic IP Plan that the JIPC deems fit, and upon approval of said changes and additions, implement said changes and additions; and
(f) consider whether it is necessary to enter into any license agreements with a Third Party in respect of a Designated Target. In the event of a conflict between the JIPC’s authority under this Section 2.5.4.1 and a Party’s rights under Section 8.3.3 or Section 8.3.4, as applicable, Mersana’s and Merck’s respective rights under Section 8.3.3 and Section 8.3.4 shall prevail.
Functions and Authority. The Joint Patent Committee will be responsible for only the following:
i. Coordinating with the Parties in accordance with Section 8.3.3 to reasonably avoid creating potential issues in prosecution of the patent applications claiming each Party’s respective Patent Rights;
ii. Subject to Section 8.3.1, discussing patent prosecution strategy relating to prosecution of Patent Rights under this Article VIII other than the Takeda Background Patent Rights, Target Program Patent Rights and Other Program Patent Rights solely owned by Takeda, and status updates with respect to such Patent Rights; and
iii. Such other matters as the Parties may mutually agree in writing.
Functions and Authority. The Joint Manufacturing Committee will be responsible for developing a plan for manufacturing process development and supply chain development, including CMO selection, including coordinating inspections of potential CMOs by both Parties, reviewing the progress of such plan, reviewing and serving as a forum for discussing and approving changes to such plan, any Supply Agreement or change in facility location, and such other matters as the Parties may mutually agree in writing. The Joint Manufacturing Committee will keep Joint Scientific Committee reasonably informed of the foregoing.
Functions and Authority. The mission of the Neutral Nations Supervisory Commission shall be to carry out the functions of supervision, observation, inspection, and investigation, as stipulated in Sub-paragraphs 13(c) and 13(d) and Paragraph 28 hereof, and to report the results of such supervision, observation, inspection, and investigation to the Military Armistice Commission.
Functions and Authority. The authority of the designated and alternate stewards designated by the Union shall be limited to, and shall not exceed, the following duties and activities:
1. The investigation and presentation of grievances and the participation in the Grievance/Arbitration procedures, including Employer conducted investigatory interviews, as provided in Section (Investigatory Interviews of Unit Employees by Management and Supervision) or Article (Discipline and Discharge) and Article (Grievance and Arbitration Procedure) of this Agreement;
2. The collection of dues when authorized by the appropriate Local Union official;
3. The transmission of such messages and information which shall originate with, and are authorized by the Local Union, or its officers, provided such messages and information:
(a) have been reduced to writing, or
(b) if not reduced to writing, are of a routine nature and do not involve work stoppages, slow-downs, refusals to handle goods, or any other interference with the Employer’s business. The designated and alternate stewards are employees of DHL and have no managerial or supervisory authority. The designated xxxxxxx and alternate stewards have no authority to take strike action or any other action interrupting the Employer’s business, except as authorized by official action of the Union which it communicates in advance to the Company. The Employer recognizes these limitations upon the authority of the designated xxxxxxx and alternate stewards, and shall not hold the Union liable for any unauthorized acts. The Employer, in so recognizing such limitations upon the authority of the designated xxxxxxx and alternate stewards, shall have the authority to impose proper discipline, including discharge, in the event the designated xxxxxxx and/or alternate stewards has/have taken an unauthorized strike action, slow down, or work stoppage in violation of this Agreement.
Functions and Authority. The authority of the designated and alternate stewards designated by the Union shall be limited to, and shall not exceed, the following duties and activities:
1. The investigation and presentation of grievances and the participation in the Grievance/Arbitration procedures, including Employer conducted investigatory interviews, as provided in Section (Investigatory Interviews of Unit Employees by Management and Supervision) or Article
Functions and Authority. The Joint Scientific Committee will be responsible for supervising and managing the Programs. Its functions will be:
i. Reviewing and approving Program Plans and amendments or other modifications thereto;
ii. Guiding and reviewing the progress of the Programs;
iii. Making decisions that are assigned to the Joint Scientific Committee hereunder; and
iv. Such other matters as the Parties may mutually agree in writing.
