Master Production Record. 2.5.1 Based on the Process developed by CBSW and Clients pursuant to the Development Plan, CBSW will prepare the Master Production Record for the Process. Clients will inform CBSW of any specific requirements Clients may have relating to the Master Production Record, including, without limitation, any information or procedures Clients wish to have incorporated therein. If CBSW intends to include in the Master Production Record the use of any assay, medium, or other technology that is not commercially available, CBSW will inform Clients of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. 2.5.2 Clients will cooperate with CBSW to assist CBSW to develop the Master Production Record and Process, including, without limitation, by providing CBSW with additional information and procedures as may be required to create the Master Production Record, Process, and/or any of the following: (i) manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information, (vi) Product Specifications. 2.5.3 CBSW will deliver a draft version of the Master Production Record to Clients for review and approval, within the time period specified in the Development Plan. Clients will notify CBSW in writing of any objections to the Master Production Record, and upon such notification, representatives of CBSW and Clients will meet promptly to resolve such objections. 2.5.4 The Process, Master Production Record, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any CBSW Operating Documents or CBSW Confidential Information included in any of the foregoing, will be deemed Confidential Information of Clients and subject to the provisions set forth in Section 9. Each of the Clients has the right to use (itself or through a Third Party) the Process and/or the Master Production Record, conditioned on the following: such Client and any such Third Party must agree in writing to protect CBSW Confidential Information contained therein and such Client’s and/or any such Third Party’s use shall be limited to uses related to Product.
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Sources: Clinical Supply Agreement (Skinmedica Inc), Clinical Supply Agreement (Skinmedica Inc)