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Monday, June 14, 2021

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HYDERABAD: Bharat Biotech’s US accomplice Ocugen stated it is going to be searching for an emergency use nod for India’s first indigenously developed Covid-19 vaccine Covaxin from the Canadian well being authorities. The firm stated it has already initiated discussions with Health Canada to seek regulatory approval.
“The company will pursue expedited authorisation for Covaxin under the interim order respecting the importation, sale and advertising of drugs for use in relation to Covid-19 in Canada,” Ocugen stated in a regulatory submitting to the Securities & Exchange Commission (SEC).
Ocugen had lately acquired the Covaxin rights for the Canadian market as effectively from Bharat Biotech and final week stated it had made an upfront cost of $15 million to the Indian vaccine maker for the Canadian rights of the vaccine.
Apart from the non-refundable upfront cost, Ocugen may even be making a milestone cost of $10 million to Bharat Biotech inside 30 days of the primary business sale of Covaxin in Canada.
Earlier this month, Bharat Biotech and Ocugen had introduced that they’d amended the unique settlement inked earlier for the US market to embody the Canadian market as effectively.
Just just like the deal for the US market, aside from the upfront cost and milestone cost upon first business sale, Ocugen can be retaining 45% of the earnings from Covaxin gross sales in Canada, whereas Bharat Biotech would get 55% share of the earnings.
“In clinical trials to date, the emerging safety profile of Covaxin is supportive of it being generally well tolerated with a good safety profile, with the Ministry of Health and Family Welfare of Republic of India reporting no potential thromboembolic events following the administration of over 6.7 million doses of Covaxin in that country,” stated Dr Bruce Forrest, performing Chief Medical Officer and member of the vaccine scientific advisory board of Ocugen.





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