Manufacturing Audits Clause Samples
The Manufacturing Audits clause grants one party the right to inspect and review the manufacturing processes, facilities, and records of the other party to ensure compliance with agreed standards and requirements. Typically, this clause allows for scheduled or sometimes unannounced visits, during which auditors may examine production lines, quality control procedures, and relevant documentation. Its core function is to provide transparency and assurance that products are being manufactured according to contract specifications, thereby reducing the risk of defects, non-compliance, or quality issues.
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Manufacturing Audits. Trubion shall have the right to perform, directly or through its representatives, *** standard cGMP compliance audit per *** (up to *** per calendar year), and additional For Cause Audits, all in accordance with the audit provisions set forth in the Quality Agreement. During the standard audits, personnel of Trubion or its representatives shall have access only to those areas that are directly related to the performance of Lonza's obligations under this Agreement, including the manufacture, testing, storage and shipping of Bulk Drug. No more than a reasonable number of representatives shall be permitted on Lonza's premises for any such audit, and, at Lonza's option, each representative shall be accompanied by a Lonza employee at all times while on Lonza's premises. Lonza shall use its best efforts to ensure that Trubion has similar audit and access rights to Lonza's suppliers.
Manufacturing Audits. Helix shall have the right to perform, directly or through its representatives, certain manufacturing compliance audits as set forth in the Quality Assurance Agreement, or as otherwise agreed in writing by CPL and Helix from time to time. Helix shall be responsible for all Third Party costs of all compliance audits.
Manufacturing Audits. Owlet shall have the right, at its expense, upon reasonable advance notice and at reasonable times, to inspect and audit Supplier's facilities involved in manufacturing the Product and other operations for the purpose of and to the extent necessary for verifying Supplier's compliance with its obligations hereunder and Owlet quality system requirements, including the right to (a) inspect the Products, (b) observe manufacturing and related operations, processes and methods with respect to the Products, (c) review documentation, and (d) conduct quality assurance, quality system and regulatory compliance audits with respect to the Products. Supplier shall cooperate in good faith with Owlet's inspection and verification efforts.
Manufacturing Audits. Tercica shall have the right to perform, directly or through its representatives, certain manufacturing audits as set forth in the Quality Agreement, or as otherwise agreed in writing by CBSB and Tercica. All CBSB personnel time and resources necessary to complete the [*] manufacturing audit [*] shall be provided [*] to Tercica; provided that any CBSB personnel time and resources necessary to complete [*] manufacturing audits [*] shall be invoiced to Tercica as Additional Services in accordance with the Project Rates. Tercica shall be responsible for all third party costs of all manufacturing audits.
Manufacturing Audits. Chugai shall have customary audit rights with respect to Rani’s (and/or any CMO engaged by Rani) Manufacturing of Product, which shall be further addressed in the quality agreement. The Manufacturing process of the Device and Product, and the Device and Product supplied by Rani shall meet all quality requirements agreed by the Parties.
Manufacturing Audits. At Jazz’s reasonable request [***], Zymeworks will exercise its right to inspect, or will use reasonable efforts to obtain the right for Jazz to inspect (which may be a joint inspection with Zymeworks), Zymeworks’ CMO under the applicable agreement between Zymeworks and such CMO, to audit compliance with all Applicable Laws in the conduct of manufacturing activities hereunder, including GMP. No later than [***] following the completion of any such audit, the inspecting Party will provide the other Party and the Manufacturing Working Group with a written summary of the auditing Party’s findings, including any deficiencies or other areas of remediation that were identified during such audit, and the Manufacturing Working Group shall promptly meet to discuss any such deficiencies or other areas of remediation. Zymeworks will use reasonable efforts remediate such deficiencies[***].
Manufacturing Audits. PATHEON shall permit RELYPSA to conduct pre-approval inspections (“PAI”) and pre-PAI audits, compliance inspections and manufacturing audits of the Patheon Facility as set forth in the Quality Agreement. RELYPSA may conduct additional pre-PAI audits, cGMP-type audits, request additional audit days, or the participation of additional auditors in addition to the inspection rights provided in the Quality Agreement, subject to [***]. The right of access set forth in this Section 9.1 will [***].
Manufacturing Audits. ChemGenex shall have, and Stragen must grant or procure for ChemGenex, the right to conduct an audit of any facility where the HHT Products are being manufactured at least annually or more frequently if any questions about the quality of the HHT Products are raised by either party or by a third party.
Manufacturing Audits. During regular business hours and upon at least four (4) weeks prior notice to LONZA, PROTEON shall have the right to perform, directly or through its representatives (agreed with * 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. LONZA in advance), certain manufacturing audits as set forth in the Quality Agreement, or as otherwise agreed in writing by LONZA and PROTEON. All LONZA personnel time and resources necessary to complete the first manufacturing audit for a calendar year shall be provided at no cost to PROTEON; provided, however, any LONZA personnel time and resources necessary to complete any additional manufacturing audits (over and above one) in that same year shall be invoiced to PROTEON as Additional Services in accordance with the Project Rates, unless such additional audits are reasonably deemed necessary by PROTEON as a result of findings of the first audit. PROTEON shall be responsible for all Third Party costs of all manufacturing audits. Audits shall not exceed three (3) Business Days with no more than 2 sub-groups of Auditors.
Manufacturing Audits. Client shall have the right to perform, directly or through its representatives, certain manufacturing audits as set forth in the Quality Agreement, or as otherwise necessary for cause or as agreed in writing by LONZA and Client. All LONZA personnel time and resources necessary to complete the first manufacturing audit for a calendar year shall be provided at no cost to Client; provided, however, any LONZA personnel time and resources necessary to complete any additional manufacturing audits (over and above one) in that same year shall be invoiced to Client [*] in accordance with the Project Rates, unless such subsequent audits are for cause, in which case such audits shall be at no cost to Client. Client shall be responsible for all third party costs of all manufacturing audits. For purposes of this Article 7, “for cause” means, without limitation, a circumstance relating to the LONZA Facility or Manufacturing Process that affects or could reasonably be expected to affect LONZA’s compliance with the warranties set forth in Section 14.2.1 and Section 14.2.4.