“Approved Regulatory Authority” means the EU European Medicines Agency, the US Food and Drug Administration, SwissMedic, Japanese PMDA, Australian Therapeutic Goods Agency, South Korean Ministry of Drug Safety, Health Canada, the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) or Singapore Health Sciences Authority.
7. Partner Obligations
7.2 Regulatory. Subject to specific Work Packages, the Partner agrees to use Reasonable Efforts to develop the regulatory strategy for the Platform for use in the Field and the Project Vaccine for use in the Field, in both cases in accordance with the relevant Work Package Statement for review and approval by JMAG. Such strategy shall include the strategy with respect to any data, market or other regulatory exclusivity periods that may be applicable in the Affected Territory or a territory which may be served by an Approved Regulatory Authority.
7.3 IND or CTA. Subject to specific Work Packages, the Partner agrees to use Reasonable Efforts to file for, obtain and maintain an IND or a CTA for Project Vaccine Developed by Partner for use in the Field in both a territory served by an Approved Regulatory Agency and the Affected Territory.
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;
9. Clinical Trials
9.2 Clinical trial data. Subject to specific Work Packages with respect to each clinical trial under the Project:
9.2.1. the Partner shall procure that the Data is complete and include all completed case report forms and all other clinical trial documentation required to be in the possession of a clinical trial sponsor by Article 15(5) of Directive 2001/20/EC, Article 16 of Directive 2005/28/EC or other relevant applicable law;
9.2.2. a CEPI representative or nominee shall have the right (except for any matters which should remain blinded to CEPI in the interests of the integrity of the clinical trial) to:
– attend meetings of the TSC and the data safety monitoring board (DSMB) for the clinical trial as an observer;
– receive all papers that a member of the TSC or DSMB would be entitled to receive; and
– attend TSC or DSMB meetings by telephone or other electronic means rather than in person.
15. Project Technology – Exploitation
15.2 Right of Reference. The Parties grant each other a right of reference to the regulatory materials relating to the Platform and the Product for use in their respective fields of use.