Common use of Manufacturing for Clinical Supply Requirements Clause in Contracts

Manufacturing for Clinical Supply Requirements. CDS and/or its Permitted Subcontractors shall use Commercially Reasonable Efforts to provide an adequate and timely clinical supply, but limited to such quantities and such type and specification as set forth in Section 3.1.2 and all in accordance with GMP and/or ISO standards, to the extent applicable for clinical trials in the relevant country, and other applicable laws and regulations. The Manufacturing Costs for such supply shall be reimbursed by Alimera in accordance with Section 3.1.2 and shall be Direct Development Costs (except that the Manufacturing Costs associated with the wet AMD trial, the vein occlusion trial and the additional marketing support trial shall be deemed Direct Commercialization Costs to the extent such trials are Non-NDA Trials). All Clinical Supply Requirements (beyond those listed in Section 3.1.2) will be Alimera’s sole responsibility.