Common use of Provision of Records Clause in Contracts

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. 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 of: (i) a flow chart of synthesis performed (batch history), including summary of investigation reports, significant deviation reports, planned changes or OOS 00S 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.