Even as it prepares to conduct late stage human trials on the Oxford-AstaZeneca vaccine candidate — branded ‘Covishield’ in India — Pune-headquartered Serum Institute of India (SII) has entered into a supply and licence agreement with American vaccine developer Novavax Inc.
According to a filing with the US Securities and Exchange Commission (SEC) by the Maryland-headquartered firm late on Wednesday, the two companies entered into an agreement on July 30 for the “development, co-formulation, filling and finishing, registration and commercialisation” of its Covid-19 vaccine candidate, NVX-CoV2373.
Novavax reported on Tuesday that its candidate had “elicited robust antibody responses” during early stage human trials conducted on 50 volunteers.
The agreement will give SII exclusive right to supply the vaccine in India, and non-exclusive rights, “during the pandemic period”, in all countries except those designated by the World Bank as “upper-middle or high-income” countries. After the pandemic period, SII will be able to market the vaccine in low- or middle-income countries.
Under the agreement, Serum Institute will purchase two components of the vaccine — the antigen drug substance and Novavax’s trademarked adjuvant (a component that is added to the vaccine to help those who have been injected with it, to produce more antibodies).
The parties will “equally split the revenue from sale of the product in its licenced territory, net agreed costs,” according to the filing.
Following the pandemic period, Novavax may notify SII of any “bona fide opportunities” for it to license the vaccine to any third party vaccine maker in low- and middle-income countries. SII would have the opportunity to “match or improve” such third party’s terms, failing which Novavax would have the discretion to remove one or more non-exclusive countries from the Pune firm’s licence.
SII will employ “commercially reasonable efforts to develop and obtain regulatory approval” for the vaccine in countries in its licensed territory. The agreement will expire on a country-by-country basis 15 years after the first commercial sale of the product in those countries.
Upon expiration, SII will retain a “fully-paid, non-exclusive licence” that will allow it to continue with its manufacturing and commercialisation rights on a country-by-country basis in its licensed territory.
SII is also engaged in developing a Covid-19 vaccine with another American firm, Codagenix. This vaccine is still in the pre-clinical stage.
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