Provision of Records. The Contractor and Subcontractor(s) shall produce within five (5) Days on the Site of the Work and upon a written order of the Project Manager, the Commissioner, the ACCO, the EAO, or the Comptroller, such records as are required to be kept by this Article; and
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.
Provision of Records. The Contractor and Subcontractor(s) shall produce within five
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. Manufacturer shall maintain full Batch records that will be accessible to Rhythm on the premises of the Manufacturer. Batch excerpts shall be made available to Rhythm or its nominee within twenty (20) working days at Rhythm’s request. Those Batch excerpts consist of (i) a flow chart of synthesis performed (batch history), including summary of investigation reports, significant deviation reports, planned changes or OOS results generated during manufacture of the Product, (ii) a Certificate of Analysis (CoA), and (iii) a Certificate of Compliance (CoC) (collectively, “Batch Documentation”). For each Batch of Product, Batch Documentation will be delivered at no cost to Rhythm by a reputable overnight courier or by registered or certified mail, postage prepaid, return receipt required to verify delivery date. Upon request Manufacturer will deliver to Rhythm a complete and accurate copy of the Batch records for each Batch of Product. Upon request, 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. Such information (apart from Batch Documentation) requested by Rhythm from Manufacturer will be delivered at cost. If * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Rhythm requires additional copies of such information, these will also be provided by Manufacturer to Rhythm at cost.
Provision of Records. With each batch of Drug Substance or Drug Product delivered by Takeda pursuant to Section 7.1, Takeda shall provide all Batch Documentation for such batch, including a certificate of analysis and certificate of conformance.
Provision of Records. The Collector shall provide OTS’s auditor or designated representative with any and all records requested and shall cooperate with the Audit at no expense to OTS. It is agreed that OTS shall bear the cost of performing the Audit except in circumstances where the auditor determines that the Collector has not complied with the terms of this Agreement and the Plan in which case OTS’ reasonable costs of the Audit, including any follow-up review or inspection undertaken as a result of a finding of non-compliance, shall be paid by the Collector within 30 days of demand therefor being transmitted from OTS to the Collector. In the event the Collector fails to pay OTS’ reasonable costs of the Audit as aforesaid, such costs of the Audit shall be treated as Repayment Amounts and subject to set-off in accordance with Section 7.3.
Provision of Records. The Hauler shall provide OTS’s auditor with any and all records requested and shall cooperate with the Audit at no expense to OTS. It is agreed that OTS shall bear the cost of performing the Audit except in circumstances where the auditor determines that the Hauler has not complied with the terms of this Agreement and the Plan in which case OTS’ reasonable costs of the Audit, including any follow-up review or inspection undertaken as a result of a finding of non-compliance, shall be paid by the Hauler within 30 days of demand therefor being transmitted from OTS to the Hauler. In the event the Hauler fails to pay OTS’ reasonable costs of the Audit as aforesaid, such costs of the Audit shall be treated as Repayment Amounts and subject to set-off in accordance with Section 7.3.
Provision of Records. The Processor shall provide OTS’s auditor with any and all records requested and shall cooperate with the Audit at no expense to OTS. It is agreed that OTS shall pay the costs of the Audit except in circumstances where the auditor determines that the Processor has not complied with the terms of this Agreement and the Plan in which case OTS’ reasonable costs of the Audit, including any follow-up review or inspection undertaken as a result of a finding of non-compliance, shall be paid by the Processor within 30 days of demand therefor being transmitted from OTS to the Processor. In the event the Processor fails to pay OTS’ reasonable costs of the Audit as aforesaid, such costs of the Audit shall be treated as Repayment Amounts and subject to set-off in accordance with Section 7.3.
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.
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.
