Common use of Audit Notice Clause in Contracts

Audit Notice. Client shall provide SBL with a written notice at least [***] prior to the initiation of the audit or visit to the Facility and, if necessary the Warehouse, set forth in Section 8.2.1, which shall be conducted on a mutually agreeable date and time, and with a mutually agreed duration, agenda, and visitor list. Notwithstanding the foregoing, if the audit or visit is required for cause (i) due to safety reasons that necessitate immediate audit of or visit to the Facility or (ii) Client asserts that a violation of the Quality Agreement has occurred which cannot be resolved through the normal Core Team / JSC process, the foregoing sentence shall not apply and Client may conduct such audit or visit as soon as reasonably possible by providing SBL with a prior notice by email. Access to SBL’s facilities shall be coordinated with SBL so as to minimize disruption to SBL’s ability to perform services for its other clients. Client representatives must comply with all of SBL’s cGMP, confidentiality and security procedures and protocols during such observations, consultations, and inspections. SBL shall at all times cooperate and provide all the necessary documents reasonably required by Client during such audit; provided that, to the extent necessary, SBL may redact that portion of documents to protect the confidential information of its other clients. Client shall be responsible for any costs and liability to the extent caused by Client’s or its representatives’ failure to comply with SBL’s security, safety or confidentiality procedures.

Audit Notice. Client shall provide SBL * with a written notice at least [***] three (3) months prior to the initiation of the audit or visit to of the Facility and, if necessary in the judgment of Client, the Warehouse, set forth in Section 8.2.18.3.1, which shall be conducted on a mutually agreeable date and time, and with a mutually agreed duration, agenda, and visitor listnumber of attendees, which in the case of Client shall not be limited to less than three (3) without the consent of Client. Notwithstanding the foregoing, if the audit or visit is required for cause (i) due to safety reasons or other reasons that necessitate necessitates immediate audit of or visit to the Facility or (ii) Client asserts that a violation of due to the Quality Agreement has occurred which cannot be resolved through the normal Core Team / JSC process* Assignable Error, the foregoing sentence shall not apply and Client may conduct such audit or visit as soon as reasonably possible by providing SBL * with a prior notice by email. Access to SBL*’s facilities shall be coordinated with SBL * so as to minimize disruption to SBL*’s ability to perform services for its other clients. Client representatives must comply with all of SBL*’s generally applicable cGMP, confidentiality and security procedures and protocols during such observations, consultations, and inspections. SBL * shall at all times cooperate and provide all the necessary documents reasonably required by Client during such audit; provided that, to the extent necessary, SBL * may redact that portion of or withhold documents to protect the confidential information of its other clients. Client shall be solely responsible for any costs and liability to the extent caused by Client’s or its representatives’ failure to comply with SBL*’s security, safety or confidentiality procedures. * Confidential material redacted and filed separately with the Commission.

Audit Notice. Client shall provide SBL with a written notice at least [***] three (3) months prior to the initiation of the audit or visit to of the Facility and, if necessary in the judgment of Client, the Warehouse, set forth in Section 8.2.18.3.1, which shall be conducted on a mutually agreeable date and time, and with a mutually agreed duration, agenda, and visitor listnumber of attendees, which in the case of Client shall not be limited to less than three (3) without the consent of Client. Notwithstanding the foregoing, if the audit or visit is required for cause (i) due to safety reasons or other reasons that necessitate necessitates immediate audit of or visit to the Facility or (ii) Client asserts that a violation of due to the Quality Agreement has occurred which cannot be resolved through the normal Core Team / JSC processSBL Assignable Error, the foregoing sentence shall not apply and Client may conduct such audit or visit as soon as reasonably possible by providing SBL with a prior notice by email. Access to SBL’s facilities shall be coordinated with SBL so as to minimize disruption to SBL’s ability to perform services for its other clients. Client representatives must comply with all of SBL’s generally applicable cGMP, confidentiality and security procedures and protocols during such observations, consultations, and inspections. SBL shall at all times cooperate and provide all the necessary documents reasonably required by Client during such audit; provided that, to the extent necessary, SBL may redact that portion of or withhold documents to protect the confidential information of its other clients. Client shall be solely responsible for any costs and liability to the extent caused by Client’s or its representatives’ failure to comply with SBL’s security, safety or confidentiality procedures.

Audit Notice. Client shall provide SBL with a written notice of a Standard Audit at least [*** * *] prior to the initiation of the audit or visit to Standard Audit of the Facility and, if necessary the Warehouse, set forth in Section 8.2.17.2, which shall be conducted on a mutually agreeable date and time, and with a mutually agreed duration, agenda, and visitor list[* * *]. Notwithstanding the foregoing, if the audit or visit is required for cause (i) due to safety reasons that necessitate immediate audit of or visit to the Facility or (ii) Client asserts that a violation of the Quality Agreement has occurred which cannot be resolved through the normal Core Team / JSC processFor Cause Audits, the foregoing sentence shall not apply and Client may conduct such audit or visit as soon as reasonably possible by providing SBL with a prior notice by email. Access to SBL’s facilities shall be coordinated with SBL so as to minimize disruption to SBL’s ability to perform services for its other clients. Client representatives must comply with all of SBL’s cGMP, confidentiality and security procedures and protocols during such observations, consultations, and inspections. SBL shall at all times cooperate and provide all the necessary documents reasonably required by Client during such audit; provided that, to the extent necessary, SBL may redact that portion of or withhold documents to protect the confidential information of its other clients. Client shall be solely responsible for any costs and liability to the extent caused by Client’s or its representatives’ failure to comply with SBL’s security, safety or confidentiality proceduresprocedures that are communicated to Client before or during such audit or that Client or its employees know or should know are generally expected to be complied with in such audit.