Provision of Records. If, based upon such tests and documentation review, a Batch of Product conforms to the Specifications and was Manufactured according to cGMP (if applicable) and the Manufacturing Process, then a Certificate of Compliance will be completed and approved by the quality assurance department of Manufacturer. This Certificate of Compliance, a Certificate of Analysis, the Specifications, and a complete and accurate copy of the Batch records (collectively, the “Batch Documentation”) for each Batch of Product will be delivered to Rhythm by a reputable overnight courier or by registered or certified mail, postage prepaid, return receipt required to verify delivery date. Upon request, at reasonable frequency, Manufacturer will also deliver to Rhythm all raw data, reports, authorizations, certificates, methodologies, raw material specifications, SOPs, standard test methods, and other documentation in the possession or under the control of Manufacturer relating to the Manufacture of each Batch of Product. If Rhythm requires additional copies of such Batch Documentation, these will be provided by Manufacturer to Rhythm at cost.
Appears in 3 contracts
Samples: Development and Manufacturing Services Agreement, Development and Manufacturing Services Agreement (Rhythm Pharmaceuticals, Inc.), Development and Manufacturing Services Agreement (Rhythm Pharmaceuticals, Inc.)
Provision of Records. If, based upon such tests and documentation review, a Batch of Product conforms to the Specifications and was Manufactured according to cGMP (if applicable) and the Manufacturing Process, then a Certificate of Compliance will be completed and approved by the quality assurance department of Manufacturer. This Certificate of Compliance, a Certificate of Analysis, the Specifications, and a complete and accurate copy of the Batch records (collectively, the “Batch Documentation”) for each Batch of Product will be delivered to Rhythm Tectonic by a reputable overnight courier or by registered or certified mail, postage prepaid, return receipt required to verify delivery date. Upon request, at reasonable frequency, Manufacturer will also deliver to Rhythm Tectonic all raw data, reports, authorizations, certificates, methodologies, raw material specifications, SOPs, standard test methods, Records and other documentation Supporting Documentation in the possession or under the control of Manufacturer relating to the Manufacture of each Batch of Product (or any intermediate or component of Product). If Rhythm Tectonic requires additional copies of such Batch Documentation, these will be provided by Manufacturer to Rhythm Tectonic at cost.
Appears in 1 contract
Samples: Development and Manufacturing Services Agreement (AVROBIO, Inc.)