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. Records which include the information relating to the manufacturing, packaging and quality operation for each lot of Product shall be prepared by Supplier for each lot at the time at which such operations occur. The records shall include, but are not limited to, the following documentation: manufacturing, raw materials and components charge-in-records; mixing and filling records; packaging component charge-in records; packaging records; container and component traceability records; in-process and final laboratory testing results; in-process and final product physical inspection results; yield reconciliation for bulk and finished product; label samples; deviations and/or excursions from approved procedure (as well as the Supplier investigation and corrective actions) incurred during the processing and packaging of the lot. Company may review the original documents for each lot at its request when auditing the manufacturing site of Product(s). Supplier shall keep all batch records according to this section [*] after the expiration date of each Product lot.
Batch Records. GMN shall prepare and maintain Batch Records with respect to each production lot of Product, including information relating to the manufacturing, quality control testing and analysis in accordance with applicable Laws. Such Batch Records and all other records relating to production hereunder shall be retained by GMN in accordance with the Technical Agreement. In addition, GMN shall make available such Batch Records, as well as updates to the validation package for Product, to PDL during any audit or site visit in accordance with Section 6.2.
Batch Records. Batch records, including information relating to the manufacturing, packaging, labeling, and quality control testing and analysis for each lot of finished Product produced hereunder, will be prepared as and when BMS performs any such tasks, in accordance with applicable Laws and BMS’ then current standard operating procedures. Batch records and all other records relating to production hereunder shall be retained by BMS for the period required by applicable Laws. Batch records for any SKU of the Product, as well as updates to the validation package for the Product, will be made available during an Audit. Upon request of the Company not more than once every calendar quarter, BMS will copy and provide to the Company batch records for each SKU of the Product.
Batch Records. Records which include the information relating to the manufacturing, packaging and quality operation for each lot of Product will be prepared by [MANUFACTURER] at the time such operations occur. [MANUFACTURER] will prepare such records in accordance with cGMP’s, the Specifications and the Technical Quality Agreement.
Batch Records. Records which include the information relating to the manufacturing, packaging and quality operations for each lot of Captisol delivered or to be delivered hereunder shall be prepared by CyDex for each lot at the time such operations occur. Such records shall be prepared in accordance with Good Manufacturing Practices and any similar laws or regulations of applicable Major-Market Regulatory Authorities and CyDex’s standard operating procedures. These documents for each lot may be reviewed by Hospira at CyDex’s and each of its subcontractors’ site of manufacturing of the Captisol upon Hospira giving CyDex [***] written notice of its intent to review such documents; provided, however, that in the event of any regulatory or quality issues relating to the Captisol, Hospira shall be permitted to review such documents as soon as practicable after giving notice to CyDex of its intent to do so. CyDex shall keep batch records for each lot of Captisol for the period of time required by any and all applicable statutes, ordinances and regulations of Major-Market Regulatory Authorities, including without limitation, the Act and the regulations promulgated by the FDA.
Batch Records. To the extent any batch records related to the manufacture of BioNTech Products by Genevant are required to be reviewed in order for BioNTech to conduct any clinical trials, such batch records may only be made available to employees of BioNTech or its Affiliates who have signed a separate non-disclosure agreement relating to the use of the batch records under which such employees will agree to only use such batch records for quality purposes relating to the relevant batches Manufactured by Genevant, to maintain the batch records in strict confidence and not to use the batch records in the research and development of any products or technology including or relating to LNP (other than BioNTech Products). Such employees will not be involved in or have any responsibility or decision making authority for the research and development of any products or technology including or relating to LNP (other than BioNTech Products).
Batch Records. Talecris GmbH shall provide to Xxxxx a written report for each production batch (each a “Manufacturing Record”) for the purpose of complying with the registration and the documentation requirements of applicable Regulations, including without limitation, ED GMP Guidelines and of ED directive 91/356 article 9, as each may be amended from time to time, and any successors thereto.
Batch Records. Records which include the information relating to the manufacturing, packaging and quality operation for each lot of Product shall be prepared by Gland for each lot at the time at which such operations occur. The records shall include, but are not limited to, the following documentation: manufacturing, raw materials and components charge-in-records; mixing and filling records; packaging component charge-in records; packaging records; container and component traceability records; in-process and final laboratory testing results; in-process and final product physical inspection results; yield reconciliation for bulk and finished product; label samples; deviations and/or excursions from approved procedure (as well as the Gland investigation and corrective actions) incurred during the processing and packaging of the lot. Sagent may review the original documents for each lot at its request when auditing the sites of manufacture of Products. Copies of all batch records and deviation/exception reports are to be sent to Sagent’s QA organization for release review for the first three lots of Product and every tenth lot thereafter. Copies of all batch records and deviation / exception reports shall also be made available upon reasonable request.
Batch Records. CIRCA will supply for each batch of Product, including ------------- each pilot batch, complete batch production and control records. Records which include the information relating to the manufacturing, packaging and quality operation for each lot of Product will be prepared by CIRCA at the time such operations occur. The records will include, without limitation, mixing and filling records; container and component traceability records; equipment usage records; in-process and final laboratory testing results; in-process and final Product physical inspection results; yield reconciliation for bulk and finished Product; labeling and packaging records; and records relating to deviations from approved procedure, as well as CIRCA's investigation and corrective actions. Copies of batch records will be forwarded to CEPHALON prior to or along with shipment of each Product lot.
