Common use of Batch Records Clause in Contracts

Batch Records. Batch records, including information relating to the Manufacturing for each lot of finished Generic Product produced hereunder, will be prepared in accordance with cGMP. Batch records and all other records relating to Manufacturing hereunder shall be retained by Salix for such period of time as is required under applicable rules and regulations of the FDA. In the event (i) Salix receives a regulatory letter or comments from any federal agency in connection with its Manufacture of Generic Product or the facility(ies) where Generic Product is Manufactured requiring a response or action by Salix, or the Third Party manufacturer, including, but not limited to, receipt of a Form 483 (Inspectional Observations) or a “Warning Letter,” or (ii) any batch of Generic Product purchased by Xxxxxx pursuant to this Agreement is the subject of a recall or market withdrawal (each of (i) and (ii) a “For Cause Incident”), promptly following Xxxxxx’x prior written request therefor, Salix shall make available to Xxxxxx, at Salix’s premises during business hours, a complete copy of an executed batch record for each SKU of Generic Product associated with such For Cause Incident. Additionally, Salix shall, upon Xxxxxx’x written request in connection with any audit under Section 4.8, and to the extent applicable, make available for review by Xxxxxx during the course of such audit, updates to the process validation report and equipment cleaning validation for Generic Product. Any representative of Xxxxxx shall be accompanied by a representative of Salix at all times during any such review. All records made available to Xxxxxx hereunder shall be considered highly confidential materials of Salix, shall not be disclosed by Xxxxxx to any person, and shall be used by Xxxxxx solely for purposes of ensuring compliance by Salix with its obligations hereunder.

Batch Records. Batch records, including information relating to the Manufacturing manufacturing, Packaging, and quality control testing and analysis for each lot of finished Generic Product produced hereunder, will be prepared in accordance with cGMPSeller’s standard operating procedures. Batch records and all other records relating to Manufacturing production hereunder shall be retained by Salix Seller for such period of time as is required under applicable rules and regulations of the FDA. In the event (i) Salix Seller receives a regulatory letter or comments from any federal agency in connection with its Manufacture manufacture of Generic the Product or the facility(ies) facility where Generic the Product is Manufactured manufactured requiring a response or action by SalixSeller, or the Third Party third party manufacturer, including, but not limited to, receipt of a Form 483 (Inspectional Observations) or a “Warning Letter,” or (ii) any batch of Generic Product purchased by Xxxxxx Purchaser pursuant to this Agreement is the subject of a recall or market withdrawal (each of (i) and (ii) a “For Cause Incident”), promptly following Xxxxxx’x Purchaser’s prior written request therefortherefore, Salix shall Seller make available to XxxxxxPurchaser, at SalixSeller’s premises during business hours, a complete copy of an executed batch record for each SKU of Generic Product associated with such For Cause Incident. Additionally, Salix Seller shall, upon Xxxxxx’x Purchaser’s written request in connection with any audit under Section 4.8Audit, and to the extent applicable, make available for review by Xxxxxx Purchaser during the course of such auditAudit, updates to the process validation report and equipment cleaning validation for Generic each Product. Any representative of Xxxxxx shall be accompanied by a representative of Salix at all times during any such review. All records made available to Xxxxxx Purchaser hereunder shall be considered highly confidential materials of Salix, shall Seller and may not be disclosed by Xxxxxx to any person, and shall be used by Xxxxxx solely Purchaser for any purpose other than the furtherance of the purposes of ensuring compliance by Salix with its obligations hereunderthis Agreement.