“Stop Criterion” means the occurrence of an adverse safety signal in any population in which the Vaccine is being or has been tested that a Party, in good faith and in accordance with such Party’s medical safety evaluation, believes gives rise to a material risk that the safety profile of Vaccine is not suitable for Regulatory Approval;
7. Novavax Commitments
7.1 Regulatory Approval
7.1.1 Novavax shall deliver to Gavi the Regulatory Submission Plan on or before [***], which shall include a timeline for submission for approval of the Vaccine by the WHO for Emergency Use Listing, and for Regulatory Approval.
7.1.2 Novavax shall:
(i) use best endeavours to obtain Emergency Use Authorisation and Emergency Use Listing for the Vaccine by no later than [***] after the expected date set out in the Regulatory Submission Plan, and in any event by no later than [***] after submission for WHO assessment through the Emergency Use Listing or WHO Prequalification procedure; and shall ensure WHO submission is no later than the time of submission to the Stringent Regulatory Authority which is appointed to be the National Regulatory Authority of Record; and
(ii) use Commercially Reasonable Endeavours to obtain Regulatory Approval for the Vaccine, by no later than [***] after the expected date set out in the Regulatory Submission Plan.
7.1.3 Novavax shall use Commercially Reasonable Endeavours to obtain such regulatory approvals as are required to enable the Vaccine to be used in each COVAX Participant country where allocated COVAX Doses are intended to be sold pursuant to this Agreement, taking into account cost, complexity of obtaining approval in such COVAX Participant country and the benefit of such regulatory approval.
7.1.4 Where Novavax receives Emergency Use Authorisation for the Vaccine, but the Vaccine has not yet been granted Regulatory Approval, Novavax shall meet any requirements attached to the Emergency Use Authorisation.
7.1.5 Gavi recognizes the resource requirements for potentially complex regulatory processes and will [***], through outreach within the COVAX Facility and its partnerships in efforts to promote the use by COVAX Participant countries of either Emergency Use Listing and/or WHO Prequalification (including to the COVAX Partners). However, Novavax recognizes that Gavi cannot compel any regulatory authority to take any particular actions.
13. Term and Termination
13.2.3 If a Party, in good faith, considers the conditions of a Stop Criterion to be met, it shall notify the other Party thereof (the “Safety Notice”).