Provision Language
Definitions
“Outbreak” means a Public Health Emergency of International Concern declared by WHO, or a public health emergency on a national or regional scale declared by one or more public health agencies, with respect to Middle East respiratory syndrome (MERS) including any regional outbreak, an epidemic or a pandemic.
“Increased Outbreak Preparation Need” means when, having considered the reasonably accessible and relevant information including epidemiological data, travel and migration patterns and the likely availability of other products or product candidates, CEPI determines, acting reasonably following consultation with experts (for example a sub-group or subcommittee of CEPI’s Scientific Advisory Committee that CEPI determines has appropriate expertise), that, as evidenced by an increase in the number of actual cases of MERS being reported, there is a heightened need for the Project Vaccine to address potential Outbreaks.
“Selected Manufacturer” means an LMIC-based manufacturer within CEPI’s list of preferred manufacturers and which is either (i) agreed with the Partners under the iPDP or (ii) otherwise agreed between CEPI and the relevant Partner(s).
“Ready Reserve of Project Clinical Trial Material” means an agreed quantity of doses of the Project Vaccine for potential use in a clinical trial. At the Effective Date, Barinthus Bio has agreed that it will, subject to achievement of the relevant Stage Gate, manufacture or have manufactured and store as a Ready Reserve of Project Clinical Trial Material [***] in accordance with GMP and all other requirements and specifications agreed with CEPI. Promptly following achievement of the relevant Stage Gate, Barinthus Bio will submit to CEPI a reasonable budget detailing the reasonable costs of storage and stability testing of the Ready Reserve of Project Clinical Trial Material for approval by CEPI, such approval not to be unreasonably withheld, conditioned or delayed. From time to time, Barinthus Bio shall submit to CEPI revised budgets detailing such costs for approval by CEPI, such approval not to be unreasonably withheld, conditioned or delayed. CEPI shall bear Barinthus Bio’s out-of-pocket costs incurred in performing such storage and stability testing, provided that CEPI shall not be required to pay any mark-up or handling charges.
2. PROJECT ORGANISATION AND MANAGEMENT
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2.3 Project Continuity Plan
2.3.1 The iPDP shall include the following in order to address continuity of the Project inthe event either or both Partners becomes unable to continue its activities under this Agreement and must delegate certain activities to another Party or third party (the “Project Continuity Plan”):
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(iii) the identification of a proposed third party for each Partner, for example, a Sub-Contractor, that will, with the prior written approval of CEPI, becontracted by such Partner and will be capable of performing such Partner’s material or critical activities in the agreed Work Packages in geographically diverse locations, in the event that such Partner is unable to continue its activities under this Agreement or declines CEPI’s request to undertake additional Work Packages; and
(iv) a preliminary identification of one or more Selected Manufacturers for technology transfer in the event of an Outbreak or Increased Outbreak Preparation Need in accordance with Clause 4.2.
4. FUNDING FOR FUTURE PROJECTS; TECHNOLOGY TRANSFER TO A SELECTED MANUFACTURER
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4.2 Collaboration in Event of Outbreak. Should there be an Outbreak or Increased Outbreak Preparation Need at any time during the Term:
4.2.1 if CEPI believes, in its reasonable discretion, that the Project Vaccine can be used to help address the relevant Outbreak or Increased Outbreak Preparation Need, each Partner shall, subject to receipt of sufficient funding, continue to develop, and, if relevant, manufacture or have manufactured (to GMP, or another clinical standard if agreed between the Parties), and distribute such Project Vaccine, as agreed with CEPI;
4.2.2 to the extent such technology transfer has not already occurred, at such time as is mutually agreed between the Parties, and on such terms as agreed between the Partner and the relevant third party, acting in good faith, each Partner shall use all reasonable endeavours to transfer or grant licenses or sublicenses to its Background IP, Project Data and Project IP (including, for the avoidance of doubt, all product data, product dossiers, and regulatory submissions submitted to a Regulatory Authority in relation to the Project Vaccine) necessary for the manufacture of the Project Vaccine to a Selected Manufacturer to manufacture such vaccines to address an Outbreak or Increased Outbreak Preparation Need, provided that the foregoing obligations shall apply only if:
(i) CEPI reasonably anticipates that the Partners cannot meet CEPI’s good faith and reasonable estimate of the anticipated demand of public-sector customers in, or purchasing on behalf of, LMICs, in the timeframe required to address an Outbreak or Increased Outbreak Preparation Need and at a price consistent with the pricing provisions contained in Clause 14.5; and
(ii) the Partners have the right to grant necessary licenses or sublicenses to a third party under agreements with Third Party Collaborators, after using reasonable endeavours to secure such rights.
4.2.3 CEPI shall be responsible for the reasonable evidenced cost related to the technology transfer (including, without limitation, capacity reservation fees and process validation engineering runs), provided that, prior to commencing the technology transfer, each Partner has provided a good faith estimate of the costs that it will incur in carrying out such technology transfer and CEPI has provided written confirmation of its acceptance of such estimate. Should CEPI not provide such written confirmation then the relevant Partner shall have no obligation under Clause 4.2.2 to undertake such technology transfer. If CEPI accepts a Partner’s costs estimate, the Parties shall negotiate and enter into a Work Package setting out which activities will be performed by such Partner and the associated Budget.
6. MANUFACTURE
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6.2 Raw Materials. The Partners shall use reasonable endeavours to ensure that all manufacturing, whether performed by a Partner or by any third party acting on a Partner’s behalf, and any raw materials, components and intermediates used in the production of the Project Vaccine, are available, in stock or for purchase, initially in sufficient quantities for research and development purposes, and subsequently in quantities sufficient to meet supply needs under the Equitable Access Plan and in the event of an Outbreak or Increased Outbreak Preparation Need.
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7. CLINICAL TRIALS
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7.8 Priority for Clinical Trials. The Partners acknowledge that the pool of subjects available in areas of Outbreak to participate in a clinical trial to test the Project Vaccine may be limited. Accordingly, if WHO, CEPI or a Regulatory Authority in the area where the Project Clinical Trial is to be conducted determines that a product other than the Project Vaccine has substantially greater potential and should be prioritised instead for a particular clinical trial, the Partners shall consider in good faith any written request of CEPI not to proceed with the Project Clinical Trial of such Project Vaccine, it being understood and agreed that the determination of whether to proceed or not proceed with any such Project Clinical Trial shall be made by the Partner who was to act as the sponsor of such Project Clinical Trial, in its sole discretion. Each Partner shall be reimbursed for its reasonable, non-cancellable costs incurred (whether before or after the determination) resulting from any determination to not proceed as a result of CEPI’s request.
7.9 Potential WHO Clinical Trials. In the event a Partner, pursuant to a subsequent written agreement with CEPI, participates in a Phase IIb or III clinical trial as requested by WHO to compare the Project Vaccine with any other vaccine candidates indicated for use against the same pathogen, each Partner will, promptly following the end of such clinical trial, meet and confer with CEPI regarding the results of such clinical trial and shall provide access to any data and final study reports relating to such clinical trial as may be set out in such subsequent written agreement, to the extent that WHO has given their prior written consent to such access.
13. READY RESERVE OF PROJECT CLINICAL TRIAL MATERIAL
13.1 Ready Reserve
13.1.1 CEPI and a Partner may mutually agree in writing that such Partner shall undertake the manufacturing, or having manufactured, and maintenance of a Ready
Reserve of Project Clinical Trial Material through a Work Package. If at any time a Partner wishes to dispose of the Ready Reserve of Product Clinical Trial Material it is storing, such Partner shall discuss the same with CEPI (including taking into consideration, without limitation, the shelf-life of such materials) and may only dispose of such materials after it has received CEPI’s prior written consent (which shall not be unreasonably withheld, conditioned or delayed). Such Ready Reserve of Project Clinical Trial Material may be used: (a) for further clinical trials pursuant to a mutually agreed Work Package, (b) to otherwise advance development of the Project Vaccine, provided such Research Reserve of Project Clinical Trial Material is not necessary for activities pursuant to clause (a) at such time, or (c) for emergency use (subject to obtaining all necessary regulatory approvals and consents) in emergency situations based on national or international guidance (such as from WHO) or in such other manner, in each case as may be agreed in the relevant Work Package or otherwise by the Parties in writing.
13.1.2 For the purposes of this Agreement, a “Ready Reserve of Project Clinical Trial Material” means an agreed quantity of doses of the Project Vaccine for potential use in a clinical trial. At the Effective Date, Barinthus Bio has agreed that it will, subject to achievement of the relevant Stage Gate, manufacture or have manufactured and store as a Ready Reserve of Project Clinical Trial Material [***] in accordance with GMP and all other requirements and specifications agreed with CEPI. Promptly following achievement of the relevant Stage Gate, Barinthus Bio will submit to CEPI a reasonable budget detailing the reasonable costs of storage and stability testing of the Ready Reserve of Project Clinical Trial Material for approval by CEPI, such approval not to be unreasonably withheld, conditioned or delayed. From time to time, Barinthus Bio shall submit to CEPI revised budgets detailing such costs for approval by CEPI, such approval not to be unreasonably withheld, conditioned or delayed. CEPI shall bear Barinthus Bio’s out-of-pocket costs incurred in performing such storage and stability testing, provided that CEPI shall not be required to pay any mark-up or handling charges.