Compliance Audits. D.
4.1 Compliance Audit(s). Without limiting the generality of section A.7.4 (Records Review), if requested by the Province from time to time, which request shall be at the Province’s sole discretion, the Recipient, at its own expense, will forthwith retain an independent third party auditor to conduct one or more compliance audits of the Recipient or any Project. The audit will be conducted in accordance with Canadian Generally Accepted Auditing Standards, as adopted by the Canadian Institute of Chartered Accountants, applicable as of the date on which a record is kept or required to be kept under such standards. In addition, the audit will assess the Recipient’s compliance with the terms of the Agreement and will address, with respect to each Project, without limitation, the following:
(a) whether the Funds were spent in accordance with the Agreement and with due regard to economy, efficiency, and effectiveness;
(b) the Project’s progress or state of completion;
(c) whether the financial information the Recipient provided is complete, accurate, and timely, and in accordance with the Agreement;
(d) whether the Recipient’s information and monitoring processes and systems are adequate to identify, capture, validate, and monitor the achievement of intended benefits of the Project;
(e) the overall management and administration of the Project;
(f) recommendations for improvement or redress; and
(g) whether prompt and timely corrective action is taken on prior audit findings.
Compliance Audits. This Contract may be audited by the Owner, DSBS and the City Comptroller to determine the Contractor’s compliance with the requirements of the Owner’s M/WBE Program and the Contractor’s M/WBE Utilization Plan.
Compliance Audits. Flexion and its designated representatives shall have the right to audit all applicable non-financial records of Patheon for the purpose of determining Patheon’s compliance with the obligations set forth in this Agreement and the Technical Transfer Agreement, including Sections 2.2(a) and 6.2 of this Agreement, and the terms of any Purchase Order. Such audit right shall include the right to inspect: (a) the Materials used in the Manufacture of the Product, (b) the holding facilities for such Materials and Product, (c) the Equipment used in the Manufacture of the Product, (d) all non-financial records relating to the Manufacturing Suite and the Manufacturing of the Product (subject to any other restrictions set forth in this Agreement) and (e) all other documentation set forth in the Quality Agreement. Flexion shall provide Patheon with reasonable prior advance notice of its intention to conduct such audit and the Parties will determine a mutually agreeable date for such audit. Flexion shall include no more than […***…] of Flexion’s representatives in each such audit, with each such audit lasting no more than […***…] days without Patheon’s prior written consent. Flexion may exercise its audit rights under this Section 3.8 no more than […***…] per calendar year; provided that, in the event any of the following circumstances arise, Flexion may elect and Patheon shall permit Flexion to conduct additional audits in a timely manner: (i) where there is the occurrence of a condition or event relating to the Materials or any Product which constitutes a serious health risk; (ii) where either Party has received correspondence or a report from a Regulatory Authority pointing out a deficiency in the Product by or on behalf of Patheon; (iii) where the Specifications have not been complied with or there is otherwise evidence that compliance with the Specifications is at risk; or (iv) in the event of a recall related to the Product. The Steering Committee will discuss the findings of any audit conducted by Flexion under this Section 3.8 and shall mutually agree upon a plan to remedy any issues identified by Flexion in such audit and Patheon shall use commercially reasonable efforts to implement such plan in a timely manner. Patheon will support the first Product approval, including its inspection if required, of the FDA or equivalent regulatory launch for other jurisdictions (where applicable) (a “PAI”) (including one mock-readiness review and efforts conducted with Flexi...
Compliance Audits. In its agreements with the various regulatory bodies, Precise ParkLink (West) Ltd. agrees to allow their auditors reasonable access to our business premises containing registered owner information without prior notice. Precise ParkLink (West) Ltd. has never had its access suspended or any terms and conditions imposed by anybody for failure to comply with any of our access agreements.
Compliance Audits. Once per year during the term of this Agreement and for one year thereafter, on dates and at times agreed upon by the parties, COMPANY shall have the right to have up to two (2) representatives present at the Facility, for up to two (2) days, in order to conduct a compliance audit of DPT’s facilities pertaining to the manufacture, laboratory work, packaging, storage, testing, shipping or receiving of the Product and its components.
Compliance Audits. Upon notice from MII, MVWC shall provide MII, its auditors (including internal audit staff and external auditors), inspectors, regulators and other reasonably designated representatives as MII may from time to time designate in writing (collectively, the “MII Auditors”) with access to, at reasonable times, to any MVWC facility or part of a facility at which MVWC is using the Transition Services, to MVWC personnel, and to data and records relating to the Transition Services for purposes of verifying compliance with this Agreement. MII audits may include security reviews (including MVWC’s completion of security related questionnaires) of the Transition Services and MVWC’s systems, including reasonable use of automated scanning tools such as network scanners, port scanners, and web inspection tools. MVWC will provide any assistance that MII Auditors may reasonably require with respect to such audits.
Compliance Audits. MOVA shall permit representatives of DEPOMED to conduct audits to confirm MOVA’s compliance with cGMPs and Specifications upon reasonable advance notice and subject to the provisions of Article 6. MOVA shall notify DEPOMED within twenty-four (24) hours after it receives notice of an FDA audit or inspection involving the Product, any component thereof, or any portion of MOVA’s facility used or likely to be used in connection with the activities of MOVA to be conducted under this Agreement, and shall allow DEPOMED to be present and to participate in any such inspection. In each such case, whether or not DEPOMED attended such audit or inspection provide to DEPOMED copies of any resulting document of action (FDA Form 483 inspection observation report, regulatory letters, etc.) resulting from these audits, which pertains to the Product, any component thereof, or any portion of MOVA’s facility used or likely to be used in connection with the activities of MOVA to be conducted under this Agreement, within two (2) calendar days after receipt. Should either MOVA or DEPOMED receive any such document of action, it shall so notify the other within two (2) business days after receipt and shall provide to the other an opportunity to the extent feasible under the circumstances, to provide input to any response to any such document of action.
Compliance Audits. 11.1 Sunesis reserves the right to have a “person in plant” during any manufacturing or testing activities.
11.2 Sunesis reserves the right to conduct an annual audit, in person or by other means, of any work performed, and compliance to GMPs and other applicable regulations, as well as an initial qualification audit. For cause” audits may be scheduled in addition to the qualification and/or annual audit. “Man-in-plant” during Sunesis project work is not considered an audit.
11.2.1 If deviations or concerns are noted within the audit, AAIPS will provide a written response to Sunesis’ written audit report within four (4) weeks of receipt of the report from Sunesis. The response will include the corrective actions to be taken by AAIPS, if any, and a timeline for such implementation.
11.3 Reasonable prior notice will be given before any visit or audit, and audits will be conducted at mutually agreed upon times. Prior to an audit, Sunesis will communicate to AAIPS the scope of the audit.
11.4 In the event of an inspection by any governmental or regulatory authority concerning the work being performed for Sunesis, AAIPS shall notify Sunesis promptly upon learning of such an inspection. AAIPS shall also supply Sunesis with copies of any FDA Form 483, any correspondence or portions of [ * ] = 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. correspondence relating to Sunesis’ materials and shall inform Sunesis of the general findings and outcomes of such inspections. By: /s/ Xxxxxx X. Xxxxxxx By: /s/ Xxxxxxxxxxx Xxxxx Name: Xxxxxx X. Xxxxxxx Name: Xxxxxxxxxxx Xxxxx Title: Senior Vice President, Research & Development and Quality Title: VP, Quality & Regulatory Affairs Date: October 25, 2010 Date: October 25, 2010 [ * ] = 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. This Master Services Agreement (“Agreement”) is made and entered into as of January 1, 2010 (the “Effective Date”), by and between Albany Molecular Research, Inc., having its principal place of business at 00 Xxxxxxxxx Xxxxxx, Xxxxxx, Xxx Xxxx 00000 (together with its subsidiaries hereinafter collectively referred to as “AMRI”)...
Compliance Audits. 12 5.1 Manufacturing Audits.................................................................................................................................................................................................................................................................................. 13
Compliance Audits. XXXXXX will have the right to perform compliance/quality audits, as set forth in the QUALITY AGREEMENTS.
