Quality Audits. (a) Upon reasonable advance notice and during reasonable business hours, Alliqua shall have the right to inspect and audit those portions of CCT’s and its Affiliates’ and its Permitted Subcontractors’ facilities in which the Manufactured Products are manufactured, stored or tested, to ascertain compliance with cGTPs, applicable Law, and the terms and conditions of this Agreement and the Quality Agreement; provided, however, that (i) Alliqua’s representatives shall follow all security and facility access procedures as reasonably required by CCT or its Affiliate or Permitted Subcontractor, as applicable, and (ii) Alliqua may not exercise its right under this Section 3.8(a) more than once in any twelve (12)-month period (unless such inspection and audit reveals a material compliance issue, in which event Alliqua shall have the right to conduct a follow-up inspection and audit to verify that such issue has been remedied). CCT shall use commercially reasonable efforts to promptly resolve, and to cause its Affiliates and its Permitted Subcontractors to promptly resolve, any quality issues raised by any inspections and audits of their respective facilities.
(b) Upon reasonable advance notice and during reasonable business hours, CCT shall have the right to inspect and audit (i) those portions of Alliqua’s facilities in which the Manufactured Products are stored, handled or labeled and (ii) if Alliqua elects to manufacture, store, and test Alliqua’s requirements of the Manufactured Products or designate another person or entity to manufacture, store, and test Alliqua’s requirements of the Manufactured Products, in accordance with Section 2.4(a), those portions of Alliqua’s facilities or those of its designated Person, as the case may be, in which the Manufactured Products are manufactured, stored, handled or labeled, in each case, to ascertain compliance with cGTPs, applicable Law, and the terms and conditions of this Agreement and the Quality Agreement; provided, however, that (i) CCT’s representatives shall follow all security and facility access procedures as reasonably required by Alliqua, as applicable, and (ii) CCT may not exercise its right under this Section 3.8(a) more than once in any twelve (12)-month period (unless such inspection and audit reveals a material compliance issue, in which event CCT shall have the right to conduct a follow-up inspection and audit to verify that such issue has been remedied). Alliqua shall use commercially reasonable effort...
Quality Audits. Arena shall maintain all quality control documentation and Product Acceptance Test results for each Batch of Finished Product for a period and in a manner consistent with Regulatory Standards and the Quality Agreement. Eisai may periodically (but no more frequently than once per Calendar Year) review such documentation and results, and, as provided for in the Quality Agreement, audit and verify the adherence of Arena to the Quality Control Procedures and Regulatory Standards. Such review and audit shall be on reasonable prior notice and conducted during business hours and in a manner that does not unreasonably disrupt Arena’s business or operations.
Quality Audits. SANParks will be entitled to conduct regular quality audits to ensure that the quality of the foodstuffs, goods and services provided by the Third Party consistently meet desired standards. Such quality audits shall be conducted by way of “mystery customers”, spot checks, customer questionnaires and SANParks quality control checks or other measures as deemed necessary by SANParks.
Quality Audits. Illumina agrees to allow Customer to audit Illumina’s operations that pertain to TG Consumables, upon […***…] prior written notice, during normal business hours, no more often than […***…], and at […***…], in order to satisfy its obligations under applicable law. The locations, times, dates, scope, and goals for such audits will be mutually agreed upon in writing between the Parties. Customer shall sign Illumina’s confidentiality agreement, if requested by Illumina, prior to conducting such audit.
Quality Audits. Buyer may audit any Supplier facility and records related to this Agreement during Supplier’s regular business hours with reasonable advance notice to evaluate Supplier’s quality and food security and defense procedures and compliance with Specifications. Buyer may conduct these audits itself or through its third-party representatives or Buyer will require Supplier to select an auditor from Buyer’s then-current list of approved third-party auditors for the Products. Supplier will not request that Buyer or any auditor selected by Buyer sign an additional agreement in order to conduct the audit, and Buyer will protect all Confidential Information it learns during the audit under the Confidentiality section. Buyer may also require that Supplier complete a questionnaire either in lieu of or in advance of an audit, or that Supplier register with and provide information to a third-party that Buyer has selected to manage audit information. Buyer will bear its own internal costs and Supplier will bear all other audit costs (including those of the third-party auditors). If Buyer learns of any breaches of this Agreement, Supplier will promptly take all corrective action that Buyer reasonably requires. Buyer will not audit more frequently than once per year unless Buyer has a reasonable health, food safety, or quality concern related to this Agreement or unless Buyer is ensuring that previously identified breaches have been corrected.
Quality Audits. With respect to work performed under Section 4.4 by Emisphere and Emisphere’s supply of Program Carriers under Section 6.4, Novo Nordisk shall have the right, at its own costs, once a year upon reasonable prior written notice to conduct during business hours quality assurance audits of the relevant parts of Emisphere quality management systems and of development, manufacturing, storage or shipping facilities, including computer systems such as those that capture, analyze or store study information or results, where work on the development, manufacture, storage or shipping of Program Carriers and/or Licensed Product(s) is conducted, as reasonably deemed necessary by Novo Nordisk in order to ensure that such facilities meet the standards of Novo Nordisk and any applicable Regulatory Authority, including cGCP, cGLP and cGMP. If a Quality Audit identifies any non-conformity, Emisphere must rectify such non-conformity within a time period mutually agreed by the Parties.
Quality Audits. Owner may perform periodic audits of the Project, or of documents related to the Project, to the extent necessary (in Owner's reasonable judgment) to verify the application of the Quality Assurance Plan set forth in Appendix K hereto and its results. In the event that, as a result of an audit, Owner detects a failure to adhere to or to properly apply such Quality Assurance Plan, upon the receipt of notice thereof from Owner, Contractor shall take all actions necessary to correct such failure. 146
Quality Audits. SeaSpine shall allow Integra to perform quality audits at its manufacturing facility for the Products during regular business hours and upon reasonable prior written notice if Integra has reasonable cause to believe there is a quality issue affecting the Products, or as required by applicable law. Integra shall provide SeaSpine with a written report of all nonconformances to the manufacturing procedures, storage and shipping procedures and test/inspection procedures within thirty (30) days of identification, which non-conformances are identified by Integra during quality audits.
Quality Audits. The Licensee shall immediately notify the Licensor of any quality audits conducted by WHO or a Stringent Regulatory Authority that results in any major observations or actions in relation to Licensed Compound and/or Licensed Product or the manufacturing sites where Licensed Compound and/or Licensed Product is being manufactured or proposed to be manufactured.
Quality Audits. (a) Supplier will allow Purchaser to reasonably audit Supplier and the Facility for the purposes of evaluating and verifying compliance with the Compliance Requirements. Any audit undertaken pursuant to this Section 7.02(a) shall be subject to the following conditions: (i) Supplier shall be given no less than two (2) Business Days’ prior notice of any For Cause Audit, and no less than fifteen (15) Business Days’ prior notice of any other proposed audit; (ii) each such audit shall be conducted during normal working hours and shall take no longer than three (3) Business Days, so long as Supplier furnishes all information requested by Purchaser in a timely fashion; and (iii) each Party shall bear its own costs and expenses incurred in connection with any such audit.
(b) Purchaser may exercise its audit rights under Section 7.02(a) once per calendar year during the Term or otherwise on a frequency as mutually agreed by the Parties and additionally, as may be necessary, in the case of For Cause Audits.
