Development Committee. The Joint Management Committee will establish a development and commercialization committee (the "Development Committee") to oversee the pre-clinical and clinical Development and Commercialization of Products in the Field, and, if XOMA elects to Co-Promote such Product as provided in Section 4.1 below, Co-Promotion of Products in the Field. Decisions of the Development Committee will be by unanimous agreement; provided, however, that subject to the terms of this Agreement it is agreed that (x) Alexion shall have primary responsibility for clinical development; (y) XOMA shall have primary responsibility for the development of clinical and commercial-scale manufacturing processes and shall have primary responsibility for and control the preparation of chemistry and manufacturing controls documentation and/or submission of any drug master file relating to a Product manufactured by XOMA; and (z) Alexion shall have primary responsibility for pre-launch and other Commercialization activities. Should the members of the Development Committee fail to agree on any matter for which unanimous agreement has been sought and Alexion or XOMA requests a resolution, the matter shall be referred to the JMC for resolution in accordance with Article 12.
Appears in 3 contracts
Samples: Commercialization Agreement (Alexion Pharmaceuticals Inc), Xoma LTD /De/, Xoma LTD /De/
Development Committee. The Joint Management Committee will establish a development and commercialization committee (the "βDevelopment Committee"β) to oversee the pre-clinical and clinical Development and Commercialization of Products in the Field, and, if XOMA elects to Co-Promote such Product as provided in Section 4.1 below, Co-Promotion of Products in the Field. Decisions of the Development Committee will be by unanimous agreement; provided, however, that subject to the terms of this Agreement it is agreed that (x) Alexion shall have primary responsibility for clinical development; (y) XOMA shall have primary responsibility for the development of clinical and commercial-scale manufacturing processes and shall have primary responsibility for and control the preparation of chemistry and manufacturing controls documentation and/or submission of any drug master file relating to a Product manufactured by XOMA; and (z) Alexion shall have primary responsibility for pre-launch and other Commercialization activities. Should the members of the Development Committee fail to agree on any matter for which unanimous agreement has been sought and Alexion or XOMA requests a resolution, the matter shall be referred to the JMC for resolution in accordance with Article 12.
Appears in 2 contracts
Samples: Commercialization Agreement, Commercialization Agreement (Alexion Pharmaceuticals Inc)