Common use of Manufacturing Process Validation Clause in Contracts

Manufacturing Process Validation. Promptly after the Parties have completed the Master Batch Records, and at Cempra’s request, FFFC will commence and conduct certain validation studies (the “Validation Studies”) to validate the API Manufacturing Procedures pursuant to a mutually agreeable validation plan, in preparation for commercialization, to be reasonably negotiated in good faith and agreed upon in writing by the Parties (which plan, upon such agreement in writing by the Parties, will be set forth in Exhibit H). The actual detailed protocols for such Validation Studies shall be established by the FFFC, in consultation with, and subject to the written agreement of, Cempra, with FFFC preparing the initial proposed protocols for review and comment by Cempra and written approval by Cempra. FFFC shall disclose to Cempra in written reports all results of such Validation Studies and all other deliverables as required under the mutually-agreed upon plan for such Validation Studies. Notwithstanding the foregoing, unless otherwise agreed by FFFC, such protocols for the Validation Studies and such reports shall not contain any information of FFFC included as confidential in the DMF maintained by FFFC under this Agreement. Cempra shall pay FFFC as provided in the form of Exhibit H to be agreed upon for FFFC’s conduct of the Validation Studies. In the event that the Validation Studies are not successfully completed (i.e., they do not satisfy the predefined acceptance criteria in the validation protocol and related site SOPs), FFFC shall work cooperatively with Cempra using commercially diligent efforts to determine the cause of the failure, and shall work diligently and, as soon as possible, implement such changes in the Facility or as otherwise needed to assure that the Validation Studies are successfully completed. Each such validation Batch supplied by FFFC shall meet the API Specifications and shall be suitable for human clinical trial use and/or commercial use in humans, as applicable. FFFC shall use reasonable efforts to work in good faith with Cempra to obtain appropriate Marketing Approvals as needed.