Common use of Regulatory Inspections Clause in Contracts

Regulatory Inspections. APCETH will permit BBB or its designees to be present and participate in any visit or inspection by any regulatory authority of the Facility which solely relates to any Product or the manufacturing process of the Product. For the avoidance of doubt, this shall not include any visit or inspection related to other products manufactured at APCETH or the general GMP inspection by the regulatory authority. APCETH shall notify BBB promptly if a regulatory authority requests permission to inspect any Clean Room made available to BBB as set forth in Section 3.2 and/or any of APCETH’s records or documents related to APCETH’s performance under this Agreement. Upon notification of an inspection, APCETH shall promptly notify BBB of the date and time of such inspection and allow BBB to assist in the preparation for such inspection by a regulatory authority. APCETH will provide [***] notice to BBB, or as may be otherwise provided in the Quality Agreement, if the purpose of any such visit or inspection relates to or might affect the manufacture of Product, provided that the visit or inspection was announced to APCETH in advance with sufficient notice. APCETH agrees to provide BBB with copies of all regulatory authority documentation including but not limited to correspondence, statements, warnings, enforcement actions, pleadings, summons, forms and records that APCETH receives as a result of or in anticipation of an inspection of the Clean Rooms. APCETH agrees to promptly notify BBB of any findings resulting from any inspection by a regulatory authority relating to the manufacture of Product, to take any necessary corrective action within the timelines set by the relevant authority within [***] and to provide copies of any relevant correspondence to BBB within [***] after submission, or as may be otherwise provided in the Quality Agreement.

Regulatory Inspections. APCETH Cognate agrees, in each case, to the extent not prohibited by Applicable Law or the applicable Authority, to advise Asterias by telephone and email as soon as reasonably possible of any proposed or announced visit or inspection, and as soon as possible but in any case [***] any unannounced visit or inspection, by the FDA or other Authority of any Facility used to Manufacture Products under this Agreement. Subject to Cognate’s obligations of confidentiality to any third parties, to the extent practicable and if not prohibited by Applicable Laws, Cognate will permit BBB or its designees Asterias to be present and participate in any FDA or other Authority visit or inspection by any regulatory authority of the Facility which solely relates to any Product or the manufacturing process of the Product. For the avoidance of doubt, this shall not include any visit or inspection related to other products manufactured at APCETH or the general GMP inspection by the regulatory authority. APCETH shall notify BBB promptly if a regulatory authority requests permission to inspect any Clean Room made available to BBB as set forth in Section 3.2 and/or any of APCETH’s records or documents related to APCETH’s performance under this Agreement. Upon notification of an inspection, APCETH shall promptly notify BBB of the date and time of such inspection and allow BBB to assist in the preparation for such inspection by a regulatory authority. APCETH will provide [***] notice to BBB, or as may be otherwise provided in the Quality Agreement, if the purpose of any extent such visit or inspection relates directly to the Product Manufactured for Asterias by Cognate pursuant to this Agreement. Cognate will (unless prohibited by Applicable Law from doing so) provide Asterias with a copy of any report, notice or might affect other written communication received from the manufacture of Product, provided that the FDA or other Authority in connection with such visit or inspection was announced to APCETH in advance with sufficient notice. APCETH agrees to provide BBB with copies of all regulatory authority documentation including but not limited to correspondence, statements, warnings, enforcement actions, pleadings, summons, forms and records that APCETH receives as a result of or in anticipation of an inspection of the Clean Rooms. APCETH agrees to promptly notify BBB of any findings resulting from any inspection by a regulatory authority relating to the manufacture Product or the Facility (if it relates directly to or directly affects the Development and/or Manufacture of Product), which report, notice or other communication will be redacted to remove information directly pertaining to or directly affecting any other third party. Cognate will provide, to take any necessary corrective action within the timelines set extent not prohibited by Applicable Law or the relevant authority within [***] and to provide copies applicable Authority, Asterias with a copy of that portion of any relevant correspondence written response or filing Cognate submits to BBB within [***] after submissionthe FDA or other Authority addressing the Manufacture of Product or the Manufacturing Process reasonably prior to submission of such response or filing so that Asterias may comment thereon (which comments Cognate shall reasonably consider but shall not be obligated to include). Notwithstanding the preceding sentence, in no event will Asterias require Cognate to delay or as may be otherwise provided in the Quality Agreementimpair Cognate’s ability to timely respond to or submit any filing to FDA or any other Authority.

Regulatory Inspections. APCETH will permit BBB The ACCEPTOR shall allow foreign and local governmental authorities to inspect and review their facilities, operations and quality systems as necessary in order to facilitate, obtain or its designees maintain the required registration in those countries where CONTRACT GIVER and ACCEPTOR desire to be present and participate in sell PRODUCT(s). Each party acknowledges that the other party may respond independently to any visit correspondence or inquiry from any Regulatory Authority. The ACCEPTOR shall however agree to the following: • To notify the CONTRACT GIVER promptly of any inspection or inquiry by any regulatory authority Regulatory Authority concerning one or more of the Facility which solely relates PRODUCT(s). The responsible contact persons are listed in Enclosure B. • To forward to the CONTRACT GIVER copies of any Product correspondence from any Regulatory Authority relating to one or the manufacturing process more of the ProductPRODUCT(s). For the avoidance of doubtThe ACCEPTOR agrees that, this shall not include any visit or inspection related to other products manufactured at APCETH or the general GMP inspection by the regulatory authority. APCETH shall notify BBB promptly if a regulatory authority requests permission to inspect any Clean Room made available to BBB as set forth in Section 3.2 and/or any of APCETH’s records or documents related to APCETH’s performance under this Agreement. Upon notification of during an inspection, APCETH shall promptly notify BBB of the date and time of such inspection and allow BBB to assist in the preparation for such inspection by a regulatory authorityRegulatory Authority concerning one or more of the PRODUCT(s) that it will not disclose information and materials that are not required to be disclosed to such a Regulatory Authority, without the prior consent of the CONTRACT GIVER, which shall not be unreasonably withheld. APCETH The ACCEPTOR will immediately inform the responsible contact persons of the CONTRACT GIVER as listed in Enclosure B concerning any critical or major issues encountered during any Regulatory Authority inspection that might adversely affect the quality of one or more of the PRODUCT(s). The ACCEPTOR shall submit to CONTRACT GIVER, within 5 business days of receipt of the official report, a copy of the relevant parts of the report issued by the authorities and the proposed corrective actions that the ACCEPTOR will undertake. The report and the proposed corrective actions should be in English if requested by CONTRACT GIVER. CONTRACT PROVIDER should provide [***] notice the ACCEPTOR with all the necessary information to BBB, or as may be otherwise provided carry out the contracted operations correctly in accordance with the Quality Agreement, if pharmaceutical registration and any other legal requirements. The Contract Giver should ensure that the purpose Contract Acceptor is fully aware of any such visit problems associated with the product or inspection relates the work which might pose a hazard to his premises, equipment, personnel, other materials or might affect the manufacture of Product, provided other products. ACCEPTOR shall have a procedure in place to ensure that the visit or inspection was announced to APCETH qualified person releasing every batch ensures that each batch has been manufactured and checked in advance compliance with sufficient notice. APCETH agrees to provide BBB with copies the requirements of all regulatory authority documentation including but not limited to correspondence, statements, warnings, enforcement actions, pleadings, summons, forms and records that APCETH receives as a result of or in anticipation of an inspection of the Clean Rooms. APCETH agrees to promptly notify BBB of any findings resulting from any inspection by a regulatory authority relating to the manufacture of Product, to take any necessary corrective action within the timelines set by the relevant authority within [***] and to provide copies of any relevant correspondence to BBB within [***] after submission, or as may be otherwise provided in the Quality Agreementpharmaceutical registration.

Regulatory Inspections. APCETH Upon request by any properly authorized representative of any Regulatory Authority of appropriate jurisdiction to have access to or verify any record, report, documentation or data relating to a Project, Services, a Work Order, or otherwise relating to CymaBay in the possession, custody or control of CRO, CRO will permit BBB promptly notify CymaBay and will arrange access by such Regulatory Authority to CRO to the extent legally required for the purposes of verifying and/or copying any record, report, documentation or its designees data pertaining to be present the a Study or Work Order. In the event that a Regulatory Authority conducts an inspection of CRO specifically related to a Study (and participate in any visit or such Study is not selected for audit as part of a routine inspection by any regulatory authority a Regulatory Authority of the Facility which solely relates CRO’s performance of contract research organization activities), CymaBay will reimburse CRO’s reasonable costs, on a time and materials basis, incurred in connection with hosting and responding to any Product or the manufacturing process such inspection (including any preparation, participation, follow-up and resolution of the Product. For the avoidance findings) up to a maximum amount of doubt[*], this shall except that CymaBay will not include any visit or inspection related to other products manufactured at APCETH or the general GMP inspection by the regulatory authority. APCETH shall notify BBB promptly if a regulatory authority requests permission to inspect any Clean Room made available to BBB as set forth in Section 3.2 and/or any of APCETH’s records or documents related to APCETH’s performance under this Agreementreimburse CRO for [*]. Upon notification of an inspectionimpending inspection or audit by the FDA or any other Regulatory Authority at CRO’s premises, APCETH shall CRO will promptly notify BBB of the date CymaBay and time will follow up with written notification of such inspection or audit. Unless prohibited by the applicable Regulatory Authority, and allow BBB where appropriate, CymaBay will have the right, but not the obligation, to assist in the preparation for be present at any such inspection or audit and to review and comment on any responses required. CRO will provide CymaBay with monthly updates and summaries of such inspection or audit, will forward CymaBay copies of correspondence from any Regulatory Authority, and will provide CymaBay with a copy of any written correspondence to such Regulatory Authority for CymaBay’s input prior to submitting it to such Regulatory Authority, except that CRO may redact from such copy any information therein that would, if disclosed, violate any of CRO’s confidentiality obligations to third parties. CRO will promptly take steps necessary to correct any deficiencies noted by a regulatory authority. APCETH will provide [***] notice Regulatory Authority during an inspection or audit at no cost to BBB, or as may be otherwise provided in the Quality AgreementCymaBay, if such deficiencies are the purpose of any such visit or inspection relates to or might affect the manufacture of Product, provided that the visit or inspection was announced to APCETH in advance with sufficient notice. APCETH agrees to provide BBB with copies of all regulatory authority documentation including but not limited to correspondence, statements, warnings, enforcement actions, pleadings, summons, forms and records that APCETH receives as a result of or in anticipation of an inspection of the Clean Rooms. APCETH agrees to promptly notify BBB of any findings resulting from any inspection by a regulatory authority relating to the manufacture of Product, to take any necessary corrective action within the timelines set by the relevant authority within [***] and to provide copies of any relevant correspondence to BBB within [***] after submission, or as may be otherwise provided in the Quality AgreementCRO’s performance.