7. Partner Obligations
7.4 Master Files for the Platform, and for the commercial use of Project Vaccine. At the request and cost of CEPI pursuant to a specific request from a Regulatory Agency, the Partner agrees to provide copies of Master Files and existing Data for Products to Regulatory Authorities that request such information to support Regulatory Filings and submissions for the Platform and/or for Project Vaccines for use in the Field.
7.5 Meetings with Regulatory Authorities. The Partner shall invite a CEPI nominee to observe relevant interactions between the Partner and Regulatory Authorities relating to the Platform and Project Vaccines for use in the Field. At CEPI’s reasonable request, the Partner will request a meeting with Regulatory Authorities to deal with any significant unresolved issues. The Parties acknowledge and agree that CEPI is bound by confidentiality obligations to the Partner pursuant to Clause 17 of this Agreement and that confidentiality concerns will not prevent the Partner and the Regulatory Authorities from having open and frank discussions in CEPI’s presence.
7.11 Partner reporting and compliance. Subject to specific Work Packages, Partner shall provide the following reports, notifications and samples to CEPI:
7.11.6. Safety Issues. The Partner shall notify CEPI and relevant JMAG members immediately by email (with receipt acknowledgement) as well as in writing in accordance with Clause 21.9:
(i) on receipt of any information that raises any material concerns regarding safety or efficacy of Product or the Platform;
(ii) where any data relating to a Product discloses a serious adverse event;
(iii) where a serious adverse event is suspected;
(iv) on the occurrence of a serious adverse event, serious adverse reaction, or any other material safety signal;
(v) of any Product recalls; and
(vi) of any recommendations from the data safety monitoring board for a clinical trial of a Product to end a clinical trial;
(together, the “Safety Issues”).
7.11.7. Pharmacovigilance. The Partner shall notify CEPI promptly in writing of any relevant event under any pharmacovigilance activities;