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. 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. 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. 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. 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. 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. 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. CORRESPONDENCE; ------------------------------------- COMPLAINTS; RECORDS; INSPECTIONS -------------------------------- 9.1
Manufacturing Audits. (a) [* *] MA. With respect to any Contract Year, --------------------- Customer shall have the right to conduct [* *] Manufacturing Audits (as defined below) according to the terms specified in Sections 9.1(b) and 9.1(c) hereof (such [* *] Manufacturing Audits to be hereinafter referred to as a "[* *] MA"). Customer will be --------------------- responsible for any travel and personnel expenses related to the [* *] MAs. Additionally, any [* *] unless an audit establishes a material breach by Catalytica (including, without limitation, a material non-compliance with cGMPs), [* *]. (b)
Manufacturing Audits. 11.1 HOVIONE shall inform ACHAOGEN of any FDA or other Regulatory Authority inspection of the Facility in which the Product is Manufactured within [***] that such inspection is initiated or known by HOVIONE, and shall allow ACHAOGEN (or its designee) to attend and act as a consultant to HOVIONE in such audits if the inspection is directly related to the Manufacture of the Product (ACHAOGEN will have the right to be present on site, but not participate in, any such investigation or inspection).). HOVIONE shall, within [***] after receipt by HOVIONE, provide copies to ACHAOGEN of all inspection observation reports and other regulatory communications that may affect any of the Product or its Manufacture. HOVIONE shall also provide copies of HOVIONE’s proposed responses to such inspection observation reports and other regulatory communications within [***] of their preparation (the inspection observation reports, HOVIONE’s proposed and actual responses, and other regulatory communications are referred to collectively as “Regulatory Audit Materials”). ACHAOGEN will be allowed to review and comment on those Regulatory Audit Materials which pertain directly to the Product or the Manufacture thereof. HOVIONE shall promptly notify ACHAOGEN as to what corrective measure HOVIONE is taking, whether before or following any regulatory inspection or audit, and keep ACHAOGEN informed on a regular, ongoing, and periodic basis of related developments. For the avoidance of doubt, HOVIONE shall control and have full authority with regard to communications in connection with its Facilities with any Regulatory Authority.
