Quality Audit. The Private Party shall participate in and work together with SANParks in conducting and establishing quality audits.
Quality Audit. Licensor shall have a continuing right to audit and examine the manufacturing steps and processes utilized by Licensees or any permitted third party manufacturers in the manufacture of the Licensed Products as well as their adherence to Licensor’s trademark utilization criteria. No more than once per year at each facility, Licensor’s authorized representatives shall have the right, upon reasonable notice and during normal business hours, to inspect the facilities of Licensees or any permitted third party manufacturers to assure Licensor that the Licensed Products are being produced and utilized in accordance with the requirements of this Agreement and all applicable laws. If Licensor has good cause to believe that issues exist at any facility which may harm its goodwill in the Licensed Trademarks or affect the quality of the Licensed Products, then Licensor or its authorized representatives shall have the right, upon reasonable notice and during normal business hours, to conduct additional inspections of such facilities to confirm that the Licensed Products are being produced and utilized in accordance with the requirements of this Agreement and all applicable laws. Such inspectors and the inspection reports shall be subject to the same confidentiality obligations as described in the audit process in Section 3.9.
Quality Audit. Upon submission of a proposal by Progenics which is approved by PerImmune, PerImmune shall permit Progenics to audit, in cooperation with PerImmune's personnel, production, packaging, and quality control facilities of PerImmune and any of its significant suppliers as they relate to production of KLH to allow Progenics to verify PerImmune's compliance with its responsibilities under this Agreement.
Quality Audit. During normal working hours and upon reasonable notice, Knight shall be entitled to inspect areas within Synergy’s or its contract manufacturer’s establishment where Licensed Products are manufactured or stored, and to inspect the manufacturing, packaging, and quality control records relating to the Licensed Products.
Quality Audit. Unity shall be entitled, during normal working hours and upon reasonable prior notice to Ascentage, to inspect the Facility(ies), not more than once every [***], or if more frequent, at each variation of the manufacturing process for the Products. To that effect, Ascentage shall inform Unity of any variation to the manufacturing process of the Products in accordance with the Quality Agreement and as soon as reasonably practicable. Ascentage shall give Unity prior notice, to the extent practicable, of any inspections by the FDA, EMA or other regulatory authority in the Territory of the Facility(ies). Upon Unity’s reasonable written request, Ascentage shall, to the extent Ascentage has the right to do so: (a) permit a representative of Unity to be present at such inspections; (b) disclose to Unity the results of any such inspection by the FDA, EMA or any other regulatory authority in the Territory to the extent related to the Products, but in no event shall Ascentage be obligated to disclose the results of any such inspection to the extent relating to any other product of Ascentage or its Affiliates and/or (c) implement any measures necessary to respond to the regulatory authorities in a satisfactory manner. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Quality Audit. A quality agreement will be executed at the same time as, or prior to, the execution of a Project Addendum for GMP manufacture (the “Quality Agreement”). The Supply Agreement will include rights for Kolltan to audit and inspect MedImmune’s books, records and facilities as reasonably required to comply with regulatory requirements or confirm MedImmune’s compliance with its obligations under the Supply Agreement.
Quality Audit. To the extent required by law, CBC shall permit Progenics to audit, in cooperation with CBC's personnel, production, packaging, and quality control facilities of CBC and any of its significant suppliers as they relate to production of the Adjuvant to allow Progenics to verify CBC's compliance with its responsibilities under this Agreement.
Quality Audit. Licensor shall allow an independent Third Party auditor selected by Licensee and reasonably acceptable to Licensor to carry out on-site audits upon reasonable prior notice. Licensor shall permit such independent Third Party auditor to access the manufacturing, packaging, warehousing and laboratory areas related to the manufacture of the Product, including pertinent documentations. Any such audit shall take place during normal business hours and will not interfere with Licensor’s normal manufacturing operations. Licensee shall bear the cost of such audit. Licensor may require such auditor to enter into a customary confidentiality agreement to protect Licensor’s confidential information. Such auditor shall only disclose to Licensee any non-compliance with the terms of this Agreement or the Quality Agreement or applicable laws and regulations revealed by such audit, and shall not disclose any confidential information of Licensor to Licensee. In the event that such audit reveals any non-compliance, the auditor shall provide the results of the audit and the observation(s) to the Licensor and Licensee by means of a written report. If the auditor provides such written report, Licensor shall take corrective actions to remedy such non-compliance as mutually agreed upon by the Parties. The audit frequency shall be not more than once every twelve (12) months; provided that, Licensee may undertake more frequent audits if previous audits reveal quality incidents or non-compliance with applicable cGMP standards, applicable laws and regulations, or this Agreement or the Quality Agreement.
Quality Audit. 13.1 UNILIFE undertakes to run the Industrialisation in compliance in particular with ISO 13485, the Medical Devices Directive requirements (Council Directive 93/42/EEC of 14 June 1993, as amended 2007/47/EC) and FDA regulation (GMP, 21CFR Part 820, GDP). Furthermore, both Parties will agree on a regulatory plan which lists notably all relevant applicable standards, guidelines etc.
Quality Audit. At the request and expense of Neuralab, but not more frequently than [**] at a time and date reasonably acceptable to Aquila, Aquila shall permit Neuralab to audit, in cooperation with Aquila’s personnel, production, packaging, and quality control facilities of Aquila and any of its significant suppliers as they relate to production of the Adjuvant to allow Neuralab to verify Aquila’s compliance with its responsibilities under this Agreement. Neuralab and Aquila agree to cooperate in the event that Neuralab may determine, in its reasonable discretion, that changed circumstances dictate more frequent inspections.
