Examples of API Manufacturing Procedures in a sentence
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).
Upon Cempra’s written request, FFFC shall provide to Cempra, in English, the complete Master Batch Records, Batch Records, and any other API production records, and specific API Manufacturing Procedures and updates, and copies of the relevant documents containing any other FFFC technology used in manufacturing API, to the extent such technology and API Manufacturing Procedures are not maintained as confidential in the DMF maintained by FFFC.
If Cempra adopts the proposed API Specifications or API Manufacturing Procedures revision, the Transfer Prices for the API will be adjusted as per such agreement, upon the implementation of such revisions or as otherwise agreed by the Parties.
Before implementing any agreed revision to the API Specifications or API Manufacturing Procedures, the Project Managers shall, if needed, develop and agree on a reasonable and appropriate implementation plan, which sets forth the specific procedures to be used in preparing for and implementing such change to the API Specifications and/or API Manufacturing Procedures.
Notwithstanding anything to the contrary, FFFC shall not disclose any of Cempra’s Confidential Information concerning any API Manufacturing Procedures to Toyama, any Affiliate thereof, or any other Affiliate of FFFC except to the extent approved in advance and in writing by Cempra (such approval not to be unreasonably withheld).
FFFC shall prepare and maintain a DMF in the Territory for the API manufactured hereunder, and update such DMF as required by Applicable Law, with such DMF to contain reasonably appropriate information concerning Master Batch Records (and API Manufacturing Procedures) as necessary and appropriate for all Regulatory Submissions in the Territory and for the development, manufacture, commercialization, and use of Drug Product in the Territory.
FFFC shall prepare and maintain the Batch Records for each Batch of API manufactured hereunder, and shall provide Cempra, its Affiliates, and its and its Affiliates’ licensees access to such Batch Records for review and inspection, and shall provide copies thereof to Cempra upon request to the extent such technology and API Manufacturing Procedures are not maintained as confidential in the DMF maintained by FFFC.
If Cempra, in consultation with FFFC, determines that FFFC cannot implement the proposed revision to the API Specifications or API Manufacturing Procedures in a cost-effective manner, it may withdraw the proposed revision.
FFFC shall ensure that all API supplied to Cempra hereunder shall be manufactured in accordance with the API Manufacturing Procedures, cGMP, the Quality Agreement, and all other Applicable Laws, and all other applicable requirements of Regulatory Authorities, (collectively, “Regulatory Standards”) and shall comply with the API Specifications.
Without Cempra’s prior written consent, FFFC shall make no change to any part of the API manufacturing process, including: (i) the API Manufacturing Procedures; (ii) any validated analytical methods used to test critical Raw Materials, Intermediates, or the API; (iii) any Regulatory Submission (including but not limited to any DMF) made by FFFC for the API product; (iv) the Master Batch Records; and (v) Batch records or other process documentation.