Provision Language
Definitions
“Affected Territory” means any country, or any geographic area within a country, in which there is an Outbreak or for which there is an Increased Outbreak Preparation Need. For clarity, the Affected Territory includes any country in Awardee’s Traveler’s Market and any Non-Traveler’s Market Countries, in each case in which there is an Outbreak or for which there is an Increased Outbreak Preparation Need.
“Awardee’s Traveler’s Market” means those countries listed below and any country that is defined by the Organization for Economic Co-operation and Development from time to time as a high income country; provided that if any such country becomes an LMIC, such country will no longer be included in the Awardee’s Traveler’s Market and will become a Non-Traveler’s Market Country.
- USA, Canada; and
- Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden andthe United Kingdom, Andorra, Iceland, Lichtenstein, Malta, Monaco, Norway, San Marino, Switzerland; and
- Japan, South Korea, Taiwan, Singapore, Hong-Kong; and
- Australia, New Zealand; and
- Israel, Bahrain, Turkey, Kuwait, Oman, Qatar, Saudi Arabia, United Arab Emirates.
“Non-Traveler’s Market Countries” means all countries of the world other than the countries in the Awardee’s Traveler’s Market.
11. Regulatory Activities
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11.4 Regulatory Approvals in LMICs. Awardee will ensure the LMIC manufacturer will use commercially reasonable endeavours to obtain regulatory approvals and licensure for the Product in Non-Traveler’s Market countries where there is a demand for the Product. The Parties, through the JMAG, may discuss and agree on a list of such Non-Traveler’s Market countries in which to seek such approvals and licensure and on a schedule for seeking such approvals and licensure, and Awardee will, or will obligate its Sub-Awardee(s) to, use commercially reasonable endeavours to meet such schedule in such countries.
11.5 WHO Prequalification. Awardee will ensure that the LMIC manufacturer will use commercially reasonable endeavours to obtain WHO prequalification for the Product.
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16. Equitable Access
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16.6 Supply Commitment.
16.6.1 Awardee shall ensure its Sub-Awardees, to the greatest extent possible, prioritise the supply of Product to public health systems in Non-Traveler’s Market Countries taking into consideration public sector demand, production capacity and contractual obligations existing prior to any public sector purchase agreements entered into in accordance with 16.6.2.
16.6.2 Awardee shall ensure its Sub-Awardees shall use all reasonable endeavours to bid on applicable public sector tenders for the supply of Product in Non-Traveler’s Market Countries in time and at the price specified in the relevant tender (and [***]). Awardee shall ensure its Sub-Awardees use all reasonable endeavours to deliver the Product in accordance with the tender, or any subsequent purchase agreements with any public sector purchaser and meet the lead-time specified in the tender and/or purchase agreement.
16.6.3 Nothing in this Clause 16.6 shall preclude Awardee and its Sub-Awardees from supplying Product to the private market in Non-Traveler’s Market Countries as long as the Awardee or Sub-Awardee does not discriminate against the public health system in the Non-Traveler’s Market Countries in favour of the private market in such countries. In the event there is insufficient Product for Sub-Awardees to be able to fulfil orders to public sector markets, Awardee shall ensure its Sub-Awardees prioritise supply to the public market in accordance with Clause 16.6.1.
16.6.4 Except in the event that Awardee has transferred the manufacturing processes for drug substance to Awardee’s Sub-Awardee Instituto Butantan and any potential future Sub-Awardee, Awardee shall use reasonable commercial endeavours to manufacture and supply drug substance in the quantities needed to meet public sector demand in Non-Traveler’s Market Countries for the Term and for [***] following the grant of marketing approval for VLA1555 by ANVISA.
16.6.5 Within [***] of the expected launch date of each of VLA1555 and VLA1556, Awardee shall ensure that its Sub-Awardees develop and provide Awardee and CEPI with a launch readiness supply plan for Non-Traveler’s Market Countries.
16.6.6 Awardee undertakes to ensure that no LMIC Manufacturer has or will have the right to supply Product in Awardee’s Traveler’s Market.
18. Preparation for Outbreaks
18.1 Outbreak. CEPI will notify awardee in writing in the event of an outbreak or if there is an increased Outbreak Preparation Need, in each case identifying the Affected Territory (“Outbreak Notice“). Once an Outbreak Notice has been provided by CEPI, CEPI shall have the right to direct how the Safety Stock referred to in Clause 17.2. or any Product manufactured pursuant to Clause 18.2 may be used and to whom it may be provided in the Affected Territory. In consultation with relevant public health authorities in the Affected Territory, CEPI may request that Awardee discuss in good faith whether and how the Project Results could be utilized in response to the Outbreak Notice. Awardee is committed to use commercially reasonable endeavours to address Outbreaks and Increased Outbreak Preparation Need wherever they occur in the world. Following receipt of an Outbreak Notice, Awardee will use its commercially reasonable endeavours to increase the supply of Product available for use by CEPI or its nominees to an amount which equals at least [***] of the production forecast for the Products prepared by Awardee immediately prior to service of the Outbreak Notice and Awardee will use its commercially reasonable endeavours to ensure that such increased capacity is available for delivery to CEPI within [***] of the date of service of the Outbreak Notice. For clarity, Awardee will use commercially reasonable endeavours to keep such deadline of [***] (including discussing with Awardee’s contract manufacturers how they can meet the proposed deadlines), however, Awardee’s ability to meet deadlines will be subject to the lead times of Awardee’s contract manufacturers and the time required for the release testing of the Product. In the event that CEPI’s request for Product to meet the increased demand during an Outbreak or Increased Outbreak Preparation Need is in excess of the quantities that Awardee is able to supply to CEPI based on Awardee’s commercially reasonable endeavours, Awardee shall not be obliged to supply Product to CEPI under this Clause 18.1 to the extent that the supply of such quantities of Product to CEPI would result in Awardee being in breach of any binding contracts in existence on the date of service of the Outbreak Notice (which for the avoidance of doubt may include the supply of Products to customers for Awardee’s Traveler’s Market or in connection with any clinical trials). In such event, provided that Awardee has supplied Product in accordance with this Clause 18.1, Awardee shall not be considered to be in default, and Clauses 18 and 19 shall not apply.
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18.8 Outbreak in Awardee’s Traveler’s Market. Notwithstanding anything to the contrary herein, in the event any country in the Awardee’s Traveler’s Market is included in the Affected Territory, Clauses 18 and 19 shall not apply to such country in the Awardee’s Traveler’s Market on the condition that Awardee shall, at the request of public health agencies in such country in the Awardee’s Traveler’s Market, supply the Product to all such public health agencies that request the Product in a quantity and at a price as agreed with the relevant public health agencies. The price agreed with the relevant public health agency shall not exceed the lowest supply price of the Product for similar volumes of Product agreed by Awardee with any customer in the Affected Territory in the [***] preceding the receipt of the Outbreak Notice by Awardee. For purposes of this Clause 18.8, “similar volume” shall mean a volume within the range of [***]. For clarity, if Awardee fails to comply with the foregoing supply obligation with respect to any country in the Awardee’s Traveler’s Market that is included in the Affected Territory, the terms of Clauses 18 and 19 shall apply to such country in the Awardee’s Traveler’s Market that is included in the Affected Territory. However, if the reason why Awardee cannot comply with the supply obligation is that (i) the quantity of Product requested by the relevant public health agency is impossible to fulfil due to Awardee’s capacities or (ii) the price proposed by the public health agency would be unsustainable to Awardee, Clauses 18 and 19 shall not apply in such case. In any case, “sustainable price” shall never be below Awardee’s manufacturing costs.
Annex C. Integrated Product Development Plan (IPDP)
1. Project Description
1.1. Introduction and Background
The disease. To provide a sustainable commercial basis and stable market for this vaccine despite the epidemic nature of chikungunya, Valneva has developed the vaccine for high-income traveller’s markets like US and Europe. Simultaneously, to combat the huge burden from chikungunya afflicted on endemic regions, we have implemented a partnering strategy as foreseen under our 2019 CEPI grant and partnered with Instituto Butantan of Brazil for making the product available to Low- and Middle-Income Countries (LMICs).
The Butantan-Valneva partnership also enables significant development synergies, whereby data generated with Valneva’s chikungunya vaccine VLA1553 will be supporting LMIC partners to achieve licensure. For example, Valneva’s pivotal Phase 3 studies with VLA1553 in US adults, complemented by data generated in adolescents in Brazil with VLA1553 and enabled through CEPI funding, have served as the basis for the ANVISA submission of IXCHIQ, and will continue to support future licensure submission of VLA1555 (which is locally produced after tech-transfer of VLA1553 lyophilisation and packaging to Instituto Butantan).
5. Regulatory Strategy
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- The new territories split between IB [Instituto Butantan] and SII [Serum Institute of India] are as follows (amendments and agreements not yet signed):
- IB Territory is to include all LatAm countries, China, Africa, plus PAHO and GAVI; and
- SII Territory is to include India, Asia LMICs, Middle East LMICs, plus UNICEF.
- Valneva and IB finalized the re-negotiations of IB’s territory, which was agreed to include all LatAm countries, including, for avoidance of doubt, LatAm HICs, China, Africa, PAHO and GAVI.
- Meanwhile, Valneva and SII are negotiating a full deal like that of Valneva/IB wherein SII will be an exclusive licensee to VLA for the development, manufacturing (including a DP tech transfer), and commercialization of a Chikungunya vaccine in India, Asian and Middle Eastern LMICs, and UNICEF.
- The way GAVI, PAHO and UNICEF operate is currently being evaluated to decide on the best solution, especially in light of the new 2024 GAVI investment strategy.
- Regional Market Strategies:
- Latin America
- Private market: Butantan to perform NRA submissions to different countries directly or via partners (selection of distributors is ongoing). Submission and approval timelines TBD.
- Public market: Butantan to follow the regulatory processes in LatAm via WHO PQ + PAHO, which gains access to most countries. In case of WHO PQ absence, NRA submissions to different countries to be performed directly or via partners. Submission and approval timelines TBD.
- India/Asia
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- Public market: Following WHO PQ, the Indian partner will supply any Asian LMIC public market.
- Our future partner SII will also push for ‘Export Only’ license for VLA1556 whereby the product can be exported out of India without product approval in India.
- Africa: IB to stockpile and supply outbreaks via WHO PQ and supranationals (GAVI, UNICEF). African private and public markets to be further assessed.
- Supranationals (PAHO/GAVI/UNICEF): interactions have started and will continue in parallel to the WHO PQ process, so that once WHO PQ is available, the product is considered eligible for all supranational procurement.
- Latin America