Facility Audits. (a) Distributor and/or its nominee shall have the right to conduct an audit of any Approved Manufacturing Site(s) at which the Product is being Manufactured, of Manufacturing records (including batch records) relating to the production of such Product, if applicable, of the Contract Finisher(s)’ facility where Product is Packaged and of any correspondence between Cipher and the Regulatory Authority related to such Product or such facilities, in each case during business hours upon ten (10) Business Days prior written notice to Cipher but not more than once per calendar year during the Term of this Agreement, unless either Party, any Authority or any Third Party raises any questions about the quality of the Product which could have a material detrimental effect on the sales or use of the Product, in which case Distributor’s audit right shall not be subject to the foregoing annual limitation until the specific issue in question has been resolved, and Cipher shall promptly supply or cause its Approved Manufacturer to supply to Distributor all data and results relating to all Testing performed in connection with the issue in question.
Facility Audits. Subject to Xxxxxxx’x safety procedures, access control SOPs, and confidentiality limitations, Brammer will permit Customer’s representatives, not more frequently than [**], during the term of this Agreement at mutually agreed upon times to audit the Facility as more specifically set forth in the Quality Agreement, provided, however, that Customer may conduct any additional for-cause audits at mutually agreed upon times with reasonable advance notification to Brammer. Customer will give Brammer reasonable advanced notice of any proposed routine audit but no fewer than [**] prior notice for a for-cause audit, and identify the individuals who will be in attendance; provided that a general quality audit will require a minimum of [**] prior notice. All routine audits will be during Xxxxxxx’x normal business hours on weekdays and conducted in a manner that does not unreasonably interfere with Xxxxxxx’x Services and does not otherwise unreasonably interfere with normal business activities. Brammer will [**] make its Facilities and all relevant records available for inspection by representatives of Regulatory Authorities in compliance with Applicable Laws, [**] All information, records, or business information concerning Brammer that is disclosed or made available by Brammer to Customer employees and representatives, and representatives of Regulatory Authorities, or otherwise obtained by such employees and representatives, in connection with any audit will be deemed to be Confidential Information of Brammer. [**] Certain confidential information contained in this document, marked by [**], has been omitted because the information (i) is not material and (ii) would likely cause competitive harm to the Company if publicly disclosed.
Facility Audits. The JDC shall propose and submit to the JSC for approval a schedule for periodic audit and inspection of the facilities of any Third Party contract manufacturer on at least an annual basis subject to the terms of any applicable existing contract with a Third Party contract manufacturer. Pursuant to the schedule approved by the JSC, or upon request of the JDC, the Lead Manufacturing Party shall conduct an inspection or audit of the facilities of such Third Party contract manufacturers. The Lead Manufacturing Party shall provide not less than [ * ] notice to the other Party of any planned inspection and such other Party shall be permitted to participate in any audit, provided that, if the consent of the Third [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Party contract manufacturer is required under the applicable contract to allow such other Party to participate in such audit, the Lead Manufacturing Party shall use Diligent Efforts to obtain such consent. Any inspection or audit requested by the JDC (other than pursuant to the schedule approved by the JSC) shall be conducted no more frequently than [ * ] at a given facility, and shall occur as promptly as possible following written notice by the JDC of its desire for such inspection or audit, but in no event shall such inspection commence later than [ * ] thereafter (unless such audit is triggered by a material safety or GMP non-conformance issue, in which case the audit may be conducted as frequently as necessary and the maximum notice period shall be [ * ] if permitted under the applicable contract). Costs associated with auditing shall be Development Costs or Commercialization Costs as applicable.
Facility Audits. Representatives (including internal and external auditors) of Seres and its Affiliates (a) shall upon [***] review GenIbet’s quality control procedures; and (b) may, during normal business hours and [***], conduct a supplier audit of the Facility and Seres Dedicated Area. GenIbet shall make available the Facility, Seres Dedicated Area and its personnel to representatives (including internal and external auditors) of Seres and its Affiliates for purposes of verifying that the Products are being Manufactured and supplied in accordance with the applicable Specifications and Applicable Law and that GenIbet is in compliance with the terms of this Agreement. GenIbet shall promptly remedy or cause the remedy of any deficiencies that may be noted in any such audit.
Facility Audits. Upon commercially reasonable notice (to be provided not less than [***] days in advance) and during Miltenyi’s normal business hours, but not more often than [***] every [***] during the Term of this Agreement, Autolus or Autolus’ Licensees duly authorized representatives may inspect those portions of Miltenyi’s and its Affiliates’ and Subcontractors’ Facilities that are used to manufacture, store or conduct testing of Miltenyi Products to determine compliance with Applicable Laws, Regulatory Laws, Agreed Standards, the Quality Agreement and Product Specifications. Such representatives shall comply with the applicable rules and regulations for workers at such Facilities and shall enter into reasonable confidentiality and non-use agreements if so requested by Miltenyi, as a representative of Autolus or such Licensee (and not in an individual capacity). All audits shall be conducted in a manner that is intended to minimize disruption to the operations at such Facilities. Miltenyi shall promptly address and correct any deficiencies from Agreed Standards identified in connection with such inspections. Notwithstanding anything herein, Autolus or Autolus’ Licensees duly authorized representatives may conduct additional “for cause” audits to investigate a failure or potential failure of Miltenyi to adhere to the Applicable Laws, Regulatory Laws, Agreed Standards, the Quality Agreement or Product Specifications.
Facility Audits. The JDC shall propose and submit to the JSC for approval a schedule for periodic audit and inspection of the facilities of any Third Party contract manufacturer on at least an annual basis subject to the terms of any applicable existing contract with a Third Party contract manufacturer. Pursuant to the schedule approved by the JSC, or upon request of the JDC, the Lead Manufacturing Party shall conduct an inspection or audit of the facilities of such Third Party contract manufacturers. The Lead Manufacturing Party shall provide not less than [ * ] notice to the other Party of any planned inspection and such other Party shall be permitted to participate in any audit, provided that, if the consent of the Third Party contract manufacturer is required under the applicable contract to allow such other Party to participate in such audit, the Lead Manufacturing Party shall use Diligent Efforts to obtain such consent. Any inspection or audit requested by the JDC (other than pursuant to the schedule approved by the JSC) shall be conducted no more frequently than [ * ] at a given facility, and shall occur as promptly as possible following written notice by the JDC of its desire for such inspection or audit, but in no event shall such inspection commence later than [ * ] thereafter (unless such audit is triggered by a material safety or GMP non-conformance issue, in which case the audit may be conducted as frequently as necessary and the maximum notice period shall be [ * ] if permitted under the applicable contract). Costs associated with auditing shall be Development Costs or Commercialization Costs as applicable.
Facility Audits. TearLab shall have the right, during normal business hours and upon reasonable notice, to audit the Provider’s facility (or any one of such facilities) at which the Products are manufactured for compliance with the Specifications, the Regulatory Requirements, and the terms and conditions of this Agreement. MiniFAB shall give TearLab prior written notice (whenever reasonably feasible) of any Governmental Agency inspection of any facility, and shall permit a representative of TearLab to be present at such inspection. MiniFAB shall promptly provide to TearLab copies of all notices, correspondence and other materials delivered to or received from the Governmental Agency regarding such facility or the Products.
Facility Audits. Client shall have the right, acting reasonably and at its expense, upon not less than ten (10) business days advance written notice and during regular business hours, [*****], except for Cause, during the Term hereof, to inspect and audit the Facility to assure compliance with the Agreed Standards and other prevailing quality system requirements. Client shall have the right to conduct a “for Cause” audit during normal working hours with 24 hr advance notice. Such audit shall be limited to those portions of or areas within the Facility that are involved in the production of Biologic including, but not limited to, manufacturing suites and other related areas supporting production of Biologic (e.g., warehouse, water systems, storage, buffer and media prep), and shall be conducted in a manner so as to minimize disruption of business operations. Client shall have the right to appoint an appropriately qualified Third Party selected by Client and reasonably acceptable to CMO to conduct the audit. As a condition to allowing such Third Party contractor to conduct such audit, CMO and/or its Affiliate may require such Third Party to execute a non-disclosure agreement with CMO. CMO and/or its Affiliates reserve the right, at their sole discretion, to deny Client or its Third Party contractor access to documentation that constitutes or contains CMO Technology or other proprietary or Confidential Information of CMO and/or its Affiliates or any of their respective customers; provided, however, that to the extent access to any portion of such documentation is reasonably necessary for the conduct of the audit, CMO and/or its Affiliate shall permit Client or its Third Party contractor to inspect such portion of such documentation at the Facility but Client and its Third Party contractor shall not have the right to remove, copy or make detailed notes of such documentation; and provided, further, that in no event shall CMO and/or its Affiliates be obligated to provide Client or its Third Party contractor with access to any documentation (or portion thereof) to the extent that providing such access would constitute a breach or violation of CMO’s and/or its Affiliates’ obligations to any Third Party. All information disclosed to or otherwise observed by Client or its Third Party contractor during any such audit shall be deemed Confidential Information of CMO and/or its Affiliates, respectively. Client or its Third Party contractor shall at all times while present at the Facilit...
Facility Audits. Cipher and Distributor acknowledge that Cipher’s right to conduct an audit of the facilities and records of Distributor and/or its SubDistributors not more than once per calendar year pursuant to Section 6.11(b) of the Agreement shall include the facilities and records of Sub-Distributor, in the event Cipher desires to audit the facilities and/or records of Sub-Distributor, Cipher shall provide at least ten (10) Business Days notice to Distributor and Distributor shall procure access for Cipher, accompanying Distributor, to Sub-Distributor’s facilities and/or records pursuant to the notice and audit provisions of the Sub-Distribution Agreement.
Facility Audits. (a) American Regent and/or its nominee shall have the right to conduct an audit of any manufacturing site at which the Product is being Manufactured during business hours upon ten (10) Business Days prior written notice to CytoDyn not more than once per calendar year during the Term of this Agreement, unless either Party, the FDA or any Third Party raises any questions about the quality of a Product which could have a material detrimental effect on the sales or use of a Product, in which case American Regent’s audit right shall not be subject to the foregoing limitation until the specific issue in question has been resolved, and CytoDyn shall promptly supply to American Regent all data and results relating to all Testing performed in connection with the issue in question. CytoDyn shall be responsible for its own costs, and those of its contract manufacturers, for a first audit by American Regent hereunder. American Regent shall bear the fees and costs of any subsequent audit, including the fees and costs payable by CytoDyn to any Third-Party subcontractor that Manufactures the Product.
