Batch Records and Data. Within thirty (30) days following the completion of Manufacturing and Packaging of each batch, Cardinal Health shall provide Reliant with properly completed copies of Manufacturing Related Reference Documents prepared in accordance with the Specifications; provided, however, that if testing reveals an out-of-Specification result, Cardinal Health shall provide such Batch records within ten (10) days following resolution of the out-of Specification result.
Batch Records and Data. Within thirty (30) days following the completion of Processing of each batch, Catalent shall provide Client with properly completed copies of Batch records prepared in accordance with the Specifications; provided, however, that if testing reveals an out-of-Specification result, Catalent shall provide such Batch records within twenty-one (21) days following resolution of the out-of Specification result.
Batch Records and Data. Within […***…] days following the completion of Processing and Packaging of each Batch, Catalent shall provide Client with certificates of analysis and certificates of conformance. Notwithstanding the foregoing, in the event that there is an investigation of Processing or Packaging, such investigation and the time to provide the applicable certificates referenced herein shall be in accordance with the Quality Agreement.
Batch Records and Data. Upon request, within thirty (30) days following Delivery, AAC shall provide (and shall require any Third Party manufacturer to provide) Xxxxxx with properly completed copies of batch records prepared in accordance with the Specifications and applicable laws; provided, however, that if testing reveals an “out-of-Specification” result, AAC (or the Third Party manufacturer, as the case may be) shall provide such batch records within ten (10) days following resolution of the “out-of-Specification” result. The Parties agree that AAC shall provide these records to Xxxxxx solely for the purpose of assisting with manufacturing technology transfer, and Xxxxxx shall not bear the responsibility for correction of any “out-of-Specification” results.
Batch Records and Data. Within [***] ([***]) business days prior to Delivery of the first and each subsequent batch of each Product, CPL shall provide OptiNose with properly completed and accurate copies of manufacturing work orders, packaging work orders, certificates of analysis, and certificates of compliance, each in the forms attached as Schedule 2, and any other documents properly associated with the Product batch release (for example, without limitation, documents relating to any investigations concerning the batch release) (“Batch Records”). OptiNose shall have [***] ([***]) business days after receipt of all Batch Records to either provide CPL with comments or corrections to be addressed or incorporated in such documents or with a Release to Distribution letter authorizing CPL to provide Delivery of the Product.
Batch Records and Data. Within [*] days following the completion of Processing of each Batch, Catalent shall provide Client with properly completed copies of Batch records prepared in accordance with the Specifications; provided, that if testing reveals an out-of-Specification result, Catalent shall provide such Batch records within [*] days following resolution of the out-of Specification result.
Batch Records and Data. Within [**] following the completion of Packaging of each Batch, PCI shall provide Zavante with properly completed copies of Batch records prepared in accordance with the Specifications; provided, that if an unplanned deviation in the Packaging process occurs, PCI shall provide such Batch records within [**] following resolution of the unplanned deviation.
Batch Records and Data. Within a reasonable period of time following the completion of Manufacturing of the first batch of each Product, and on the anniversary of the signing of this Agreement thereafter, Elite shall provide Mikah with properly completed copies of batch records prepared in accordance with the Specifications; provided, however, that if testing reveals an out-of-Specification result, Elite shall provide such batch records within 14 days following resolution of the out-of- Specification result. In addition, for all shipments of Product, Elite shall provide Mikah with an accurate COA and Mikah shall accept such COA given in good faith, regardless of whether or not Mikah shall accept the Product.
Batch Records and Data. Seller shall provide Buyer or its designee with access to the Batch records and associated analytical test data prepared for each Batch of Product released by Seller’s quality assurance group during an audit.
Batch Records and Data. Within […***…] days following the completion of Packaging of each Batch, PCI shall provide Client with properly completed copies of Batch records prepared in accordance with the Specifications; except in the event an unplanned deviation in the Packaging process occurs, PCI promptly notify Client according to terms in the Quality Agreement. PCI shall then provide such Batch records within […***…] days following resolution of the unplanned deviation. The “Review Period” begins upon receipt of the batch records.
