For Cause Audits. If Sponsor reasonably believes that the Projects are not being performed, or were not performed, in compliance with the terms of this Agreement or a Statement of Work hereunder, Sponsor may audit BDI Pharmaceuticals and/or any Affiliate of BDI Pharmaceuticals subcontracted hereunder upon reasonable advance notice to BDI Pharmaceuticals of not less than two (2) business days and during BDI Pharmaceuticals' or its Affiliates, if applicable, regular business hours. Sponsor or its agents may inspect BDI Pharmaceuticals' or its Affiliates', if applicable, facilities and may audit all records, including, but not limited to, Study Data and accounting records, relating to the Projects, subject to all confidentiality obligations and other restrictions herein or otherwise reasonably required by BDI Pharmaceuticals, or its Affiliate, prior to such inspection. BDI Pharmaceuticals will make or cause to be made available all such records and will provide reasonable assistance in the inspection or audit. Sponsor's right to audit will survive the expiration or earlier termination of this Agreement. Audits in accordance with the terms and conditions of this Section 3.1 may occur no more than four (4) times per calendar year. Audits conducted under this Section 3.1 shall be at Sponsor's expense, provided, however, that if any audit under this Section 3.1 results in material findings, the cost of such audit shall be paid by BDI Pharmaceuticals. If Sponsor issues an audit report to BDI Pharmaceuticals, BDI Pharmaceuticals shall be allowed twenty (20) business days to correct and/or issue corrective actions for any non-conformities found in the course of the audit. BDI Pharmaceuticals lack of adherence to this timeline will result in a material breach of this Agreement.
For Cause Audits. Theravance shall also have the right to conduct “for-cause” audits to address significant product or safety concerns as discovered through Product failures related to Hospira’s manufacture of the Product. Product failures would include issues related to stability out of specification, sterility, labeling or container integrity. Theravance shall notify Hospira in writing in advance of the audit and thereafter, Theravance and Hospira shall mutually determine the timing of the audit. Each for-cause audit shall be limited to two (2) auditors for no more than two (2) days, except if the parties mutually agree that a longer for-cause audit period is necessary.
For Cause Audits. Xxxxxxx shall also have the right to conduct “for-cause” audits to address significant product or safety concerns as discovered through Product failures related to Pfizer’s manufacture of the Product. Product failures would include issues related to stability out of specification, sterility, labeling or container integrity. Xxxxxxx shall notify Pfizer in writing in advance of the audit and thereafter, Xxxxxxx and Pfizer shall mutually determine the timing of the audit, which shall be as soon as possible, and in any event within [*]. Each for-cause audit shall be [*], except if the parties mutually agree that a longer for-cause audit period is necessary.
For Cause Audits. If Sponsor has a reasonable basis to believe that the Project is not being, or has not been, performed, in compliance with this Agreement or the Protocol, Sponsor may schedule an inspection and audit of CRO, excluding accounting records, with fourteen (14) days advance notice. If Sponsor has a reasonable basis to believe that such continuing noncompliance will likely affect the health or safety of subjects, such inspection and audit may be conducted with three (3) day advance notice. For cause audits and audits to ascertain implementation of an Audit Remediation Plan shall not be subject to the limitation on frequency of audits set forth elsewhere in this Attachment 4.
For Cause Audits. Cempra shall also have the right to conduct (or to cause Hospira to allow Cempra’s Affiliates or any of Cempra’s Affiliates’ licensees or sublicensees to conduct) “for-cause” audits to address material product or safety concerns related to Product failures related to [*]. Product failures would include issues related to stability out of specification, sterility, labeling or container integrity. Cempra shall notify Hospira in writing in advance of any such audit and thereafter, the parties shall mutually agree on the timing of the audit, such agreement not to be unreasonably withheld by either party. Each for-cause audit shall be limited to [*], for no more than [*] days, except to the extent that the parties mutually agree, such agreement not to be unreasonably withheld by either party, that a longer for cause audit period is required.
For Cause Audits. Client shall also have the right to conduct “for-cause” audits to address significant Client Product or Production failures. Client Product failures shall include by way of example and not limitation, failures related to stability out of specification, sterility, or regulatory audits. Client shall notify Xxxxxx in writing in advance of its intent to conduct a “for cause” audit and thereafter, Xxxxxx and Client shall mutually determine the timing of the audit.
For Cause Audits. If Dyadic reasonably believes that BDI Pharmaceuticals is not in compliance with the terms of this Agreement or other Agreements between Dyadic and BDI Pharmaceuticals, Dyadic may schedule audits upon reasonable advance notice of not less than two (2) business days and during BDI Pharmaceuticals’ regular business hours. Dyadic or its agents may inspect BDI Pharmaceuticals’ facilities and may audit records, including records relating to the implementation of, including the accounting of costs incurred, the Development Plan and/or Commercialization Plan, subject to all confidentiality obligations and other restrictions herein or otherwise reasonably required by BDI Pharmaceuticals prior to such inspection. BDI Pharmaceuticals will make available all such records and will provide reasonable assistance in the inspection or audit. Audits in accordance with the terms and conditions of Section 12.1 may occur more frequently than one (1) time per calendar year, but in no case more than four (4) times per calendar year. In the event any audit under Section 12.1 results in Material Findings, the cost of such audit shall be paid by BDI Pharmaceuticals. Dyadic will issue an audit report to BDI Pharmaceuticals and allow BDI Pharmaceuticals twenty (20) business days to correct and/or issue corrective actions for any nonconformities found in the course of an audit. BDI Pharmaceuticals’ lack of adherence to this timeline will result in a material breach of this Agreement.
For Cause Audits. Orchid shall also have the right to conduct “for-cause” audits to address significant product or safety concerns as discovered through Product failures related to Hospira’s manufacture of Products. Product failures would include issues related to stability out 140 CONFIDENTIAL TREATMENT [***] Indicates that text has been omitted which is the subject of a confidential treatment request. This text has been separately filed with the SEC. of specification, sterility, labeling or container integrity. Orchid shall notify Hospira in writing in advance of the audit and thereafter, Hospira and Orchid shall mutually determine the timing of the audit. Each for-cause audit shall be limited to two (2) auditors for no more than two (2) days, except if the Parties mutually agree that a longer for-cause audit period is necessary.
For Cause Audits. Genzyme shall also have the right to conduct “for-cause” audits to address significant Product or safety concerns as discovered through Product failures related to Hospira’s manufacture of the Products. Product failures would include issues related to stability out of specification, sterility, labeling, container integrity, or any other issues or concerns related to Bulk. Genzyme shall notify Hospira in writing in advance of the audit and thereafter, Genzyme and Hospira shall mutually determine the timing of the audit. Each for-cause audit shall be limited to [**] auditors for no more than [**] days, except if the Parties mutually agree that a longer for-cause audit period is necessary.
For Cause Audits. For-cause audits shall be for the purpose of investigating a potential quality problem or significant complaint regarding a Product potentially attributable to Manufacturing or other operations at Mxxxx. If Medtronic believes a for-cause audit is needed, Medtronic shall notify Mxxxx of the request and reason for the for-cause audit. Mxxxx shall not unreasonably reject a request for a for-cause audit. For-cause audits shall be scheduled as quickly as possible, taking into consideration the urgency of the request, but in no event later than ten (10) days from the request date. Medtronic reserves the right to audit Sub-tier Suppliers under similar circumstances. Mxxxx shall cooperate with and support such audits and shall use reasonable efforts to maintain contractual rights to such audits.
