Quality Audits. Integra shall allow SeaSpine to perform quality audits at its manufacturing facility for the Product during regular business hours and upon reasonable prior written notice if SeaSpine has reasonable cause to believe there is a quality issue affecting the Products or as required by applicable law. SeaSpine shall provide Integra 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 SeaSpine during quality audits.
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. 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. (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.
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. 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. At Sponsor's request, BDI Pharmaceuticals shall permit each Sponsor to perform one quality audit per year without cause, and additional visits if warranted. A Sponsor is allowed to review and access: BDI Pharmaceuticals quality systems, original study records and other primary documents, redacted government inspection reports such as FDA redacted 483s, areas of the BDI Pharmaceuticals facility relevant to provision of Services to the Sponsor, including laboratories and warehousing facilities ("Quality Audit"). A Sponsor may request a Quality Audit only upon reasonable advance notice of not less than ten (10) business days and during BDI Pharmaceutical's regular business hours and one (I) time per calendar year during the term of this Agreement. BDI Pharmaceuticals will not be asked to identify its non• Sponsor clients or disclose any confidential business information provided by those clients. Sponsor shall cause its accounting firm to retain all such information subject to the confidentiality restrictions of this Agreement.
Quality Audits. Client or its designee shall have the right no more than once per calendar year, during normal hours (i.e., 8:00 a.m. to 5:00 p.m. local Facility time), to conduct a complete quality audit upon thirty (30) business days prior written notice to Cardinal Health; provided, however, that no notice shall be required if the audit pertains to recalls, product safety or potential product safety.
