Manufacturing Audits Clause Samples

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. 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. 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.

Manufacturing Audits. Immunex shall have the right to perform, directly or -------------------- through its representatives, one annual standard cGMP compliance audit, and additional For Cause Audits, all in accordance with the audit provisions set forth in the Quality Agreement. During the standard audits, personnel of Immunex or its representatives shall have access only to those areas that are directly related to the performance of Genentech'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 Genentech's premises for any such audit and, at Genentech's option, each representative shall be accompanied by a Genentech employee at all times while on Genentech's premises.

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. 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. Pharmion shall have the right to conduct an audit of the Penn facility where the Products are being manufactured at least annually or more frequently if any questions about the quality of the 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. 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 [***].