Provision Language
8. Quality Requirements and Responsibilities
8.1 Awardee shall ensure that all activities performed under this agreement shall be performed in accordance with all applicable safety, legal, ethical and regulatory authority requirements or standards, including the CEPI Third Party Code, any associated regulatory approval, clinical trials application and/or all applicable GxPs.
8.2 During the term, awardee will:
8.2.1 inform CEPI of any significant quality-related issues, events or changes that are reasonably likely to adversely affect the supply of Products to Non-Traveler’s Market Countries;
8.2.2 within [***], notify CEPI of the outcome of GxP regulatory inspections and any material adverse quality findings and any critical quality events (including serious breaches, deviations, audit findings, breaches of data integrity etc.) that are reasonably likely to adversely affect the supply of Products to Non-Traveler’s Market Countries; and
8.2.3 consider in good faith quality recommendations identified by CEPI relating to the Project as may arise throughout the course of the Term in respect of the supply of Products to Non-Traveler’s Market Countries.
8.3 Quality-related disputes between the parties that are not resolved in the normal course of business shall be brought to the attention of the JMAG in writing. Both Parties shall use all reasonable endeavours to agree to a prompt resolution of the disagreement and agree to work jointly to develop a strategy for such solution. If the quality-related dispute relates to the LMIC Manufacturer, Awardee shall encourage the LMIC Manufacturer to work jointly with CEPI to develop a strategy for solution. The Parties shall record any such resolution in writing.
8.4 Awardee shall, and shall use commercially reasonable endeavours to facilitate that the LMIC Manufacturers, permit CEPI, or its designee (subject to prior written consent by Awardee and/or the LMIC Manufacturer (as applicable) or such designee, not to be unreasonably conditioned, withheld or delayed), to conduct a detailed due diligence assessment of the relevant party’s quality systems on-site, provided such site visits shall be restricted to [***] visit per manufacturer each [***] during the Term. CEPI shall cause its designee to enter into a reasonably acceptable confidentiality agreement with the relevant party obliging such designee to retain all such information in confidence pursuant to such confidentiality agreement. In the event that such assessment identifies any major or critical deficiencies in the relevant party’s quality system, Awardee shall, or shall obligate the LMIC Manufacturer to, take all actions reasonably necessary to correct such deficiencies.