8. Outbreak And Risk Of Outbreak In The Field
8.1 Notification of Outbreak or Outbreak risk. CEPI shall notify Partner if there is an Outbreak in the Field or risk of an Outbreak in the Field.
[“Field” means the diagnosis, prevention and treatment of infections caused by the pathogens listed in the WHO R&D blueprint priority (December 2015 or January 2017) as updated from time to time.]
8.2 During or after the Project where Outbreak or risk of an Outbreak can be addressed by a Project Vaccine. On receipt of such notice, subject to the respective Work Packages, the Work Package Statements and the Work Package Budgets the Partner agrees to make Reasonable Efforts to:
8.2.1. continue the Development, and Manufacturing the Project Vaccine for use in the Field in the Affected Territory in accordance with the existing or mutually agreed upon IPDP [integrated product development plan] and Work Package Statements;
8.2.2. Manufacture the Project Vaccine for use in the Field in the Affected Territory in accordance with the CEPI Production Timeframe and in the quantities reasonably likely to be necessary and at a Cost of Goods in line with the methodology to determine pricing obligations set out in the CEPI Equitable Access Policy;
8.2.3. establish directly or to enter into an agreement with CEPI, a public sector agency or another Third Party, for the supply of Project Vaccine for use in the Affected Territory;
8.2.4. at the request of CEPI, agree in good faith with CEPI how the Development, and Manufacturing of the Project Vaccine can be accelerated and the amount of any additional funding necessary for such acceleration; and
8.2.5. make the Partner Contribution in accordance with the Work Package Statements.
[“Project Vaccine” means vaccines targeting Lassa, to be Developed and Manufactured, pursuant to this Agreement.]
8.3 When an Outbreak or risk of an Outbreak Cannot be Addressed by a Project Vaccine: During the Initial Project Term and for [*****] thereafter where an Outbreak or risk of Outbreak in the Field cannot be addressed by a Project Vaccine or other Product Developed subject to an Additional Work Package, CEPI may notify Partner of its interest to develop such other Product, and CEPI and Partner may agree that Partner either develops such Product, or utilizes the RNA Optimizer Toolkit [Partner methodology and processes to provide optimized nucleotide sequences] to assist CEPI to develop a candidate vaccine against that pathogen in the Field and to produce a vaccine stockpile, in each case pursuant to an Additional Work Package to be negotiated in good faith and agreed upon.
8.3.1. If Partner declines to enter into such agreement to develop Product, and subject to Partner’s obligations under Clause 8.3.2 below, then CEPI has the right to develop and stockpile such Products for potential use in the Field and to have such Product Manufactured by a Third Party in accordance with the Public Health License under Clause 11 below.
8.3.2. Upon CEPI’s notice in accordance with this Clause 8.3.2, Partner agrees to use Reasonable Efforts to submit optimized antigen nucleotide sequences utilizing the RNA Optimizer Toolkit for up to [*****] specified pathogens (based on amino acid sequences of such antigens provided by CEPI) under Additional Work Packages within the Field and during the Initial Project Term and for [*****] thereafter in order for CEPI to start its own product development. Partner agrees to provide up to [*****] optimized antigen nucleotide sequences per specified pathogen. If Partner agrees to develop another Product, such Product shall count against such [*****] pathogens above. For the avoidance of doubt regarding the scope of these activities, the Parties shall prepare an Additional Work Package that clarifies the specifications of these activities. For clarity, Partner will not be required to undertake any further development activities with respect to a Product, and CEPI with other partners will solely be responsible to advance the candidate Product for emergency use authorization or other marketing approval, such as, for example, pre-clinical studies.
8.3.3 CEPI will give Partner a Partner Right of First Refusal to Manufacture a Product developed pursuant to the foregoing Clause 8.3.2 on the Platform, subject to an Additional Work Package to be negotiated between the Parties in good faith and agreed upon setting out the activities to be conducted, Milestone Criteria, Milestone Dates, Work Package Budget, CEPI funding and the Partner Contribution. If the Partner declines to carry out such activities:
(i) CEPI may exercise the Public Health License and the activities shall be carried out by Trusted Manufacturers; and
(ii) the Partner shall comply with the provisions of Clause 12.
If the Partner agrees to carry out the activities, but the Parties are unable to reach agreement by the deadline, or are unable to agree the Additional Work Package Statement within [*****] of CEPI’s receipt of the Partner’s written notice referred to above, the terms submitted by CEPI will apply.