Common use of Provision of Records Clause in Contracts

Provision of Records. A Certificate of Analysis, the Specifications, and a complete and accurate copy of the Batch records (collectively, the “Batch Documentation”) for CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. each Batch of Product will be delivered to Alnylam by a reputable overnight courier or by registered or certified mail, postage prepaid, return receipt required to verify delivery date. Upon request, Manufacturer will also deliver to Alnylam 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 Alnylam requires additional copies of such Batch Documentation, these will be provided by Manufacturer to Alnylam at cost. In addition, at least [***] days prior to the shipment of any Product to Alnylam, Manufacturer’s quality assurance department shall provide Alnylam with (1) a Certificate of Compliance which certifies that the Batch of Product to be shipped conforms to the Specifications and was Manufactured according to cGMP (if applicable), Applicable Law and the Manufacturing Process, and (2) BSE and TSE Certificates.

Provision of Records. A If, based upon such tests and documentation review, a Batch of Product conforms to the Specifications and was Manufactured according to cGMP (if applicable), the Specifications 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, all quality control data Supporting the Certificate of Analysis, the Specifications, and a complete and accurate copy of the Batch records (collectively, the “Batch Documentation”) for each Batch of CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. each Batch of Product will be delivered electronically to Alnylam by a reputable overnight courier or by registered or certified mail, postage prepaid, return receipt required to verify delivery dateAlnylam. Upon request, Manufacturer will also deliver to Alnylam all raw data, reports, authorizations, certificates, methodologies, raw material specifications, SOPs, standard test methods, and other documentation Records 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 Alnylam requires additional copies of such Batch Documentation, these will be provided by Manufacturer to Alnylam at cost. In addition, at least [***] days prior to the shipment of any Product to Alnylam, Manufacturer’s quality assurance department shall provide Alnylam with (1) a Certificate of Compliance which certifies that the Batch of Product to be shipped conforms to the Specifications and was Manufactured according to cGMP (if applicable), Applicable Law and the Manufacturing Process, and (2) BSE and TSE Certificates.

Provision of Records. A 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 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. each Batch of Product will be delivered to Alnylam Atara by a reputable overnight courier or by registered or certified mail, postage prepaid, return receipt required to verify delivery date. Upon request, Manufacturer will also deliver to Alnylam [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Xxxxx, xx Xxxxx’s sole cost and expense, all relevant raw data, reports, authorizations, certificates, methodologies, raw material specifications, SOPs, standard test methods, and other documentation documentation, in each case, in the possession or under the control of Manufacturer and relating to the Manufacture of each Batch of Product. If Alnylam Atara requires additional copies of such Batch Documentation, these will be provided by Manufacturer to Alnylam Atara at costAtara’s sole cost and expense. In addition, at least [***] days prior Manufacturer will retain a copies of all of such Batch Documentation and Atara will provide Manufacturer full access to the shipment all original Batch Documentation if Manufacturer is required or compelled to furnish any of such original Batch Documentation in connection with a regulatory inspection by any Product to Alnylam, Manufacturer’s quality assurance department shall provide Alnylam Authority or otherwise in connection with (1) a Certificate of Compliance which certifies that the Batch of Product to be shipped conforms to the Specifications and was Manufactured according to cGMP (if applicable), Applicable Law and the Manufacturing Process, and (2) BSE and TSE CertificatesLaw.