Facility Audits Sample Clauses
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.
(b) Cipher and/or its nominee shall have the right to conduct an audit of the facilities and records of Distributor, and/or its SubDistributors relating to the Marketing, Testing, and storage of the Product and of any correspondence between Distributor, its SubDistributors and the Regulatory Authority related to the Product or such facilities, during business hours upon ten (10) Business Days prior written notice to Distributor not more than once per calendar year during the Term of this Agreement, unless any Authority or any Third Party raises any questions about the quality of the Product or the Testing, Marketing or storage thereof which could have a material detrimental effect on the sales or use of the Product, in which case Cipher’s audit right shall not be subject to the foregoing annual limitation until the specific issue or question has been resolved, and Distributor shall promptly supply to Cipher all data and results relating to all Testing performed by Distributor on the Product.
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. [**]
Facility Audits. Each Party shall be permitted to conduct an inspection or audit of the other Party's facility or a facility of any Third Party contract manufacturer under contract with such other Party for the manufacture and supply of the Bulk API or Finished Product, as applicable, in or for the Licensed Territory. The audited Party shall allow the auditing Party to make such inspection or audit of any such the audited Party facility, and shall exercise its rights under any agreement between the audited Party and any such Third Party contract manufacturer to enable the auditing Party to make such inspection or audit of such Third Party contract manufacturer's facility, in each case to the extent relevant to the Bulk API or Finished Product supplied in or for the Licensed Territory and during normal business hours. The audited Party shall reasonably cooperate with the auditing Party to facilitate such inspection or audit. Any such inspection or audit by the auditing Party pursuant to this Section 7.5 shall be conducted no more frequently than once every year at a given facility, and shall occur as promptly as possible following written notice by the auditing Party of its desire for such inspection or audit, but in no event later than [*] thereafter (unless such audit is triggered by a material safety issue, in which case the maximum notice period shall be [*]). Notwithstanding the foregoing, if any notice or observation is made by a Regulatory Authority of noncompliance of such facility with applicable Law in connection with Bulk API, the auditing Party may conduct an inspection or audit of such manufacturing facility more frequently than provided in the prior sentence to the extent necessary to confirm that the relevant matters in such notice or observation are adequately addressed. The Supply Agreement shall include additional rights of audit and inspection of facilities used to manufacture Bulk API to be supplied to Takeda in circumstances other than those described in this Section 7.5, to the extent and on such terms as the Parties may reasonably agree. Costs associated with auditing shall be solely borne by the auditing Party.
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. 2.1. GenMark or a third party designated by GenMark shall have the right to inspect/audit LBS’s facilities and the facilities located the Manufacturing Location and all documents and records relating to the Products, e.g., the design, manufacturing, quality control, testing, storage, packaging, and handling of the Products. LBS shall cooperate (and cause the cooperation) with any such inspection/audit, and comply (and cause the compliance) with any reasonable requests made by GenMark in relation to such inspection/audit. During an audit, LBS shall make a qualified member of staff available to Genmark or third party designated by Genmark. Any such inspection/audit shall be made by GenMark at (subject to Section [1.20]) GenMark’s expense during LBS’s business hours applicable to the facility at issue and with reasonable advance notice. All information gathered and data reviewed during any such audit shall be Confidential Information according to the provisions of Section 20 of this Agreement. If a third party conducts an inspection under this Section, LBS may require, and GenMark will procure, that the third party enter into a reasonable confidentiality agreement on terms no less than those set out in Section 20 of this Agreement.
2.2. Where such inspection/audit detects any manufacturing quality control issue which has an adverse impact on the quality of the Products or their compliance with Specifications, Product safety, efficacy, stability, or performance, such issue must be cured without delay by LBS at LBS’s expense (including reimbursement to GenMark for the full inspection/audit cost). LBS shall promptly provide GenMark with proposed corrective and preventive actions and with time-lines for implementation. LBS will provide GenMark with reasonable opportunities to be involved in and to provide input with respect to each corrective and preventive action.
2.3. LBS must permit and cooperate with any inspection/audit by any Governmental Authorities, and comply with any requests made by the Governmental Authorities. LBS will notify GenMark immediately of any such inspection/audit. Where it is relating to Genmark product, LBS shall promptly provide GenMark with copies of any inspection reports it receives from any Governmental Authority or notice of any claim or action from any Governmental Authority relating to non-compliance with any applicable laws, rules, or regulations. Except to the extent as may be required by law, LBS shall not communicate directly ...
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. Amneal will permit Metsera to conduct a periodic audit (not more often than once per [***], except in the event of a for-cause audit based on Metsera’s belief that there are quality issues with respect to the applicable Facility(ies) for the Manufacturing of Product) of Amneal’s and its Affiliates’ records and the Facility(ies) at which the Product is Manufactured, in accordance with the Quality Agreement. Amneal shall use reasonable efforts to include in its agreements with its Permitted Subcontractors that are entered into following the Effective Date, that the Permitted Subcontractors shall permit audits at least annually and permit one representative of Metsera to be present as an observer at any such audits that are scheduled and conducted by Amneal with respect to Products.