Common use of Committee I Clause in Contracts

Committee I. Within twenty (20) business days after the Effective Date, TARCANTA and TARCANTA LTD. shall appoint three (3) individuals and CIMAB shall appoint three (3) individuals to serve as its representatives on Committee I. Each of the Operating Parties shall have the right to change any or all of its representatives on Committee I upon written notice to the other Operating Parties. Committee I may appoint individuals to serve as representatives on subcommittees to assist Committee I with respect to any particular area required for development of the Licensed Products under the Development Plan, including, product manufacturing, process development, qualification and validation of Manufacturing Facilities necessary for the manufacture and supply of the Licensed Products, research, quality control and assurance, pre-clinical studies design, implementation and evaluation, clinical protocols design, implementation and evaluation, and regulatory filings directly related to the Licensed Products. Committee I shall: (a) Elaborate written plans for the transfer to TARCANTA or TARCANTA LTD., as designated by TARCANTA, of the Transferred Assets and all related materials and documentation; (b) Prepare and approve the Development Plan, including, without limitation, go/no-go criteria, timelines and responsibilities; (c) Monitor and make recommendations regarding the performance of the Operating Parties under the Development Plan and the conduct of the Development Work, including, without limitation, the design of clinical trial protocols and elaboration of quality controls; (d) Prepare and approve modifications to the Development Plan; (e) Adopt Specifications for the Licensed Products, taking into account any Applicable Laws; (f) Comment and advise on each of the Operating Party's plans for obtaining Regulatory Approvals relating to the Licensed Products; (g) Develop adverse event reporting criteria and procedures in accordance with Applicable Laws; and (h) Review any and all proposed publications or communications relating to the Development Plan, and activities relating to any Improvement, if applicable, and the results therefrom, and any and all proposed filings of patent applications in connection therewith.

Committee I. Within twenty (20) business days after the Effective Date, TARCANTA and TARCANTA LTD. shall appoint three (3) individuals and CIMAB shall appoint three (3) individuals to serve as its representatives on Committee I. Each of the Operating Parties Party shall have the right to change any or all of its representatives on Committee I upon written notice to the other Operating PartiesParty. Committee I may appoint individuals to serve as representatives on subcommittees to assist Committee I with respect to any particular area required for development of the Licensed Products under the Development Plan, including, including product manufacturing, process development, qualification and validation of Manufacturing Facilities necessary for the manufacture licensing and supply of the Licensed ProductsProduct, research, quality control and assurance, pre-clinical studies design, implementation and evaluation, clinical protocols design, implementation and evaluation, and regulatory filings directly related to the Licensed Products. Committee I shall: (a) Elaborate written plans for the transfer to TARCANTA or TARCANTA LTD., as designated by TARCANTA, of the Transferred Assets and all related materials and documentation; (b) Prepare and approve the Development Plan, including, without limitation, go/no-go criteria, timelines and responsibilities; (c) Monitor and make recommendations regarding the performance of the Operating Parties under the Development Plan and the conduct of the Development Work, including, without limitation, the design of clinical trial protocols and elaboration of quality controls; (d) Prepare and approve modifications to the Development Plan; (e) Adopt Specifications for the Licensed Products, taking into account any Applicable Laws; (f) Comment and advise on each of the Operating Party's plans for obtaining Regulatory Approvals relating to the Licensed Products; (g) Develop adverse event reporting criteria and procedures in accordance with Applicable Laws; and (h) Review any and all proposed publications or communications relating to the Development Plan, and activities relating to any Improvement, if applicable, and the results therefrom, and any and all proposed filings of patent applications in connection therewith.