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.
Appears in 2 contracts
Samples: Development Collaboration and Commercial License Agreement (Mersana Therapeutics, Inc.), Development Collaboration and Commercial License Agreement (Mersana Therapeutics, Inc.)
Functions and Authority. The Joint Manufacturing Patent Committee shall have responsibility will be responsible for only the following:
(1) facilitating the exchange of information between the Parties, and coordinating resolution of issues relevant Selecting mutually agreeable outside counsel to conduct Patent Prosecution Activities with respect to the Manufacturing and supply Joint Patent Rights; provided that only one Party shall be the client of Licensed Products during such outside counsel, such represented Party selected by the TermJoint Patent Committee;
(2) agreeing upon Overseeing and documenting an overall Licensed Products Manufacturing strategy coordinating Patent Prosecution Activities with respect to ensure reliable the Mersana Product Patent Rights, Mersana Other Patent Rights, Licensee Patent Rights, and timely supply for Development and Commercialization by each Party hereunderthe Joint Patent Rights;
(3) planning Subject to Section 11.3.1, discussing and coordinating Licensed Products Manufacturing activities providing Licensee with the overall patent prosecution strategy determined by Mersana for, the reasonable opportunity to comment with respect to all material steps with regard to Patent Prosecution Activities with respect to, the Mersana Product Patent Rights and supplyMersana Other Patent Rights, including process development, technology transfer, audits, inspections, manufacturing scale-up and material decisions under CMO agreementswhich comments will be considered in good faith by Mersana;
(4) developing Subject to Section 11.3.2, discussing and recommending for review and approval providing Mersana with the overall patent prosecution strategy determined by the Joint Steering Committee, as applicable and subject to Article 6Licensee for, the Global Manufacturing Plan, and any amendments or revisions thereto, and developing and approving, as applicable and subject reasonable opportunity to Article 6comment with respect to all material steps with regard to Patent Prosecution Activities with respect to, the Technical Transfer PlanLicensee Patent Rights, the XMT-1519 Technical Transfer Plan, and any amendments or revisions theretowhich comments will be considered in good faith by Licensee;
(5) selecting which Party shall be responsible for fill and finish Coordinating with the Parties in accordance with Section 11.3.4 to reasonably avoid creating potential issues in prosecution of Licensed Products in the First Supply Chainpatent applications covering each Party’s other respective Patent Rights;
(6) planning Subject to Section 11.4.10, discussing and coordinating determining activities relating to Extensions of any Licensee Patent Right, Mersana Patent Right or Joint Patent Right based on a Licensed Product; provided that except with respect to Mersana Platform Patent Rights in the establishment of the First Supply Chain and Second Supply Chain Licensee Territory (which are governed by the Parties Section 11.4.10) each Party shall have final decision-making authority for such activities in accordance with the Global Manufacturing Plan;its own territory; and
(7) reviewing, commenting on, and recommending for review and approval by the Joint Steering Committee, Such other matters 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.may mutually agree in
Appears in 2 contracts
Samples: Development Collaboration and Commercial License Agreement (Mersana Therapeutics, Inc.), Development Collaboration and Commercial License Agreement (Mersana Therapeutics, Inc.)
Functions and Authority. The Joint Manufacturing Commercialization Committee shall have responsibility for the followingfor:
(1) facilitating the exchange of information between the Partiesdeveloping, 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 supplyreviewing, including process development, technology transfer, audits, inspections, manufacturing scale-up and material decisions under CMO agreements;
(4) developing commenting on and recommending for review and approval by the Joint Steering Committee, as applicable and subject to Article 6Committee the Global Commercialization Plan, 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 PlanBranding Strategy, and any amendments or revisions thereto;
(52) selecting which Party shall be responsible for fill and finish setting overall strategic objectives related to Commercialization of Licensed Products in the First Supply ChainField throughout the world through the Global Commercialization Plan;
(3) monitoring at a high-level the Commercialization activities conducted under this Agreement;
(4) reviewing all Commercialization reports provided in accordance with Section 7.5;
(5) monitoring each Party’s performance against the then-current Global Commercialization Plan, subject to Section 7.1;
(6) planning and coordinating sharing, as may be useful to the establishment Collaboration Activities any promotional materials or educational materials used in the Commercialization of Licensed Products in the First Supply Chain and Second Supply Chain by Field throughout the Parties in accordance with the Global Manufacturing Planworld;
(7) reviewing, commenting on, establish reasonable guidelines for the participation of each Party’s representatives at scientific and recommending for review and approval by medical conferences in the Joint Steering Committeeother Party’s territory, as applicable, any amendments or revisions to the Global Development Plan that relate to Manufacturing or supply of Licensed Products including manufacturing scale-upset forth in Section 7.6.2;
(8) reviewing, commenting on and approving major changes regarding the supply chain(s) reviewing proposed Commercialization activities for Licensed Product(s), including selection Products for the Licensee Territory that will have a material impact on Commercialization of CMOs that would perform Licensed Product or Component Manufacturing Products in accordance with Good Manufacturing Practices (each such CMO so approved by the Joint Manufacturing Committee, an “Approved CMO”) and changes to facility locationsMersana Territory;
(9) reviewingreviewing proposed Commercialization activities for Licensed Products for the Mersana Territory that will have a material impact on Commercialization of Licensed Products in the Licensee Territory;
(10) facilitating the exchange of information between the Parties under this Agreement regarding the strategy for implementing the Commercialization activities;
(11) subject to Applicable Law, commenting on and approving changes to discussing each Party’s pricing strategy for Licensed Products in its territory, provided that each Party shall set the Manufacturing process for each pricing of Licensed Product and Component (including changes relating to the drug product and to the conjugation step)Products in its territory in its sole discretion; and
(1012) such other responsibilities as may be assigned to the Joint Manufacturing Commercialization Committee pursuant to this Agreement or otherwise as may be mutually agreed upon by the Parties in writing from time to time.
Appears in 2 contracts
Samples: Development Collaboration and Commercial License Agreement (Mersana Therapeutics, Inc.), Development Collaboration and Commercial License Agreement (Mersana Therapeutics, Inc.)