Common use of Provision of Records Clause in Contracts

Provision of Records. If, based upon such tests, 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 and the Specifications (collectively, the “Batch Documentation”, excluding any batch and master batch records) for each Batch of Product will be delivered to RADIUS by a reputable overnight courier or by registered or certified mail, postage prepaid, return receipt required to verify delivery date. Upon reasonable request, Manufacturer will also deliver to RADIUS 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 RADIUS has not received all such Batch Documentation at the time of receipt of the Batch, RADIUS will notify Manufacturer in writing. If RADIUS requires additional copies of such Batch Documentation, these will be provided by Manufacturer to RADIUS at cost.

Appears in 4 contracts

Samples: Development and Manufacturing Services Agreement (Radius Health, Inc.), Development and Manufacturing Services Agreement (Radius Health, Inc.), Development and Manufacturing Services Agreement (Radius Health, Inc.)

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Provision of Records. If, based upon such tests, a Batch of Product conforms to the Specifications and was Manufactured according to cGMP (if applicable) and the Manufacturing Process, and 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 Analysis, the Specifications, and a complete and accurate copy of the Specifications Batch records (collectively, the “Batch Documentation”, excluding any batch and master batch records) for each Batch of Product will be delivered to RADIUS Customer by a reputable overnight courier or by registered or certified mail, postage prepaid, return receipt required to verify delivery date. Upon reasonable request, Manufacturer will also deliver to RADIUS Customer 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 RADIUS Customer has not received all such Batch Documentation at the time of receipt of the Batch, RADIUS Customer will notify Manufacturer in writing. If RADIUS Customer requires additional copies of such Batch Documentation, these will be provided by Manufacturer to RADIUS Customer at cost.

Appears in 3 contracts

Samples: Supply Agreement (CorMedix Inc.), Supply Agreement (CorMedix Inc.), Supply Agreement (CorMedix Inc.)

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Provision of Records. If, based upon such tests, 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 Analysis, the Specifications, and a complete and accurate copy of the Specifications Batch records (collectively, the “Batch Documentation”, excluding any batch and master batch records) for each Batch of Product will be delivered to RADIUS Anterios by a reputable overnight courier or by registered or certified mail, postage prepaid, return receipt required to verify delivery date. Upon reasonable request, Manufacturer will also deliver to RADIUS Anterios 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 RADIUS Anterios has not received all such Batch Documentation at the time of receipt of the Batch, RADIUS Anterios will notify Manufacturer in writing. If RADIUS Anterios requires a reasonable number of additional copies of such Batch Documentation, these will be provided by Manufacturer to RADIUS Anterios at cost.

Appears in 3 contracts

Samples: Development and Manufacturing Services Agreement (Anterios Inc), Development and Manufacturing Services Agreement (Anterios Inc), Development and Manufacturing Services Agreement (Anterios Inc)

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