Facility Audit. RELIANT shall have the right, either by itself or through independent outside auditors or consultants, not more than once per year during the term of this Agreement, unless reasonable cause is shown, to inspect and audit any areas of PRONOVA’s facilities in which any portion of the manufacturing of the Product or the API is performed for the examination of production or quality records or to perform cGMP audits, at its sole expense, on reasonable advance notice, during PRONOVA’s normal business hours in a manner that does not interfere unreasonably with PRONOVA’s operations. Any such auditor or consultant shall enter into an agreement with the Parties on terms in which such independent auditor shall agree to maintain the confidentiality of the information obtained during the course of such audit.
Facility Audit. Curia shall give Indivior or each of its authorized representatives, which are not competitors of Curia, access to the Facility for a site and/or Facility risk evaluation, any such audit to be at Indivior's cost and expense, as set forth in an SOW or other written documentation signed by the parties. The aforementioned access shall be granted if requested by Xxxxxxxx, once per Calendar Year. The cost of such Facility audit shall be $6,700 per day for Calendar Year 2022 and thereafter such amount shall be the base cost and subject to a price increase based on PPI for each subsequent Calendar Year during the Term. Curia shall use reasonable endeavors to ensure that its employees, its Affiliates and their employees cooperate with and provide reasonable assistance to Indivior during such audit. To schedule any audit under this Section 9.5, Indivior shall give Curia reasonable advance notice, but not less than two (2) weeks' prior written notice. All audits shall be carried out during normal business hours and performed in such a manner as not to unduly delay the performance of the services hereunder or interfere with Xxxxx's business. The number of visitors during any audit is limited to two (2) persons for two (2) days. Indivior shall ensure that any of its representatives who are sent to the Facility to perform an audit pursuant to this Section 9.5 shall comply with all confidentiality, security, safety, quality or similar guidelines that apply to persons present in the Facility and that are communicated by Curia, and Indivior shall be responsible for any breach of these guidelines by such representatives.
Facility Audit. Upon prior notification to ELITE and within normal working hours, PRECISION DOSE is entitled to perform an annual quality inspection of the facilities connected with the manufacture of the Product(s). Such representatives will be allowed to access all relevant premises and facilities and to witness the manufacture of the Product(s) in all its aspects to satisfy itself of the compliance of ELITE to the Governmental Approval(s) with respect to the manufacture of the Product(s) and compliance with cGMP regulations. If deficiencies are found, the parties shall meet promptly to discuss and resolve them and PRECISION DOSE shall be entitled to make reasonable follow up inspections (as often as quarterly) to monitor the correction of the deficiencies
Facility Audit. At mutually acceptable times, SSI may: (i) audit the areas of the Supplier’s facility that directly affect the design, development, manufacture, testing, packaging, labeling, storage, and shipment of any Products; (ii) observe the design, development, manufacture, testing, packaging, labeling, storage, and shipment of any Products; (iii) observe any inspection of any such areas by the U.S. FDA or any other regulatory or certification authorities; and (iv) inspect copies of the manufacturing and related records for the purposes of assuring quality of the Products and compliance with Specifications; provided in each case that SSI is responsible for the acts of its own personnel or any auditors, and that such personnel and auditors are subject to the Supplier’s security requirements and confidentiality restrictions.
Facility Audit. Subject to OXB’s safety procedures, access control SOPs, and confidentiality obligations to other clients, OXB will permit or ensure permission for Client’s representatives, to conduct a routine audit of any OXB Facility as more specifically set forth in the applicable Quality Agreement (“Facility Audit”), such audits to be carried out in a manner that minimises any interference with OXB’s normal operations.
Facility Audit. Anytime during the continuance of this Agreement, but only once a year, on receipt of thirty (30) calendar days’ notice from HETERO, OASMIA shall permit authorised representative(s) of [***] INDICATES CONFIDENTIAL PORTION HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT AND HAS BEEN FILED SEPARATELY WITH THE COMMISSION HETERO or HETERO designated third parties to enter during working hours with prior intimation to inspect OASMIA’s Facility or any such locations agreed in the Purchase Order used for manufacturing and storage of the Products, in order to examine and supervise the process or method of manufacturing and packing and storage of the said Product, storing of the Raw Materials, ingredients and other materials used in relation to manufacture and packing of the said Products in compliance with terms and conditions of this Agreement. OASMIA shall extend full co-operation to the authorised representative(s) for conducting such inspection or supervision. The objective of such Audit shall be to ensure Manufacturer’s compliance with cGMP and FDA regulations with regards to the Manufacturing Facility, Products and related process. OASMIA will, upon request, supply copies to HETERO of all standard operating procedures/ licenses/ permits of OASMIA relevant to the Manufacturing Facility and the Product including but not limited to manufacturing processes, packing, QC, storage and release in order to verify compliance with cGMP.
Facility Audit. Details of facilities provided on site by the Development which will encourage the use of sustainable means of transport, in particular cycling and walking.
Facility Audit. CoreRx shall permit Client personnel and representative(s) to (and shall ensure that Client personnel and representative(s) shall be entitled to): (a) to inspect, observe, and audit the Processing, including the Manufacturing of Product, the Facility, and other locations at which Product is Processed and/or Manufactured, (b) to examine the condition of the Raw Materials and Product stored at the Facility, and (c) to examine all results and all other documentation related to this Agreement, including maintenance logs for the purposes of ensuring compliance with cGMP. Subject to any agreed procedures in the Quality Agreement, Client shall also be entitled to conduct audits following issuance of Form 483 or similar reports delivered by Regulatory Authorities to CoreRx pertaining to the Manufacturing of Product or the occurrence of other events which are likely to materially and adversely affect the Manufacturing of Product upon reasonable notice, during CoreRx’s regular business hours for reasonable duration (which may not exceed [***] business days) until CoreRx has corrected such deficiencies. CoreRx shall have no obligation to disclose third-party Confidential Information in connection with any audit.
Facility Audit. If Leidos is unable to determine whether Supplier is compliant with its obligations under this DPE following an audit pursuant to Section 11.3or if Leidos determines that an audit under Section 11.3will not provide Leidos with the information it needs to determine Supplier’s compliance with this DPE, Leidos may initiate an audit of Supplier’s facilities that Process Personal Information. Leidos shall provide Supplier with at least thirty (30) days prior notice of any facility audit. Supplier shall provide Leidos or Leidos’ third-party auditor with sufficient access to Supplier’s facilities and systems to permit Leidos to determine whether Supplier has complied with its obligations under this DPE.
Facility Audit. The Company shall be entitled, with 20-day prior notice and during Provider’s regular business hours, to audit at its sole expense (i) for quality assurance purposes no more than once per twelve (12) months, and (ii) for regulatory purposes, as required, Provider’s facilities, equipment and procedures that are directly used by Provider to provide Services. In exercising such audit rights, the Company and its representatives shall comply with Provider’s site access policies and obligations of confidentiality that are commercially reasonable and no less stringent than those set out in this Agreement.
