CANADA'S DEAL WITH VACCINE FIRM NOVAVAX HAS BEEN RELEASED IN REGULATORY FILINGS, SHOWING THE DRUG MAKER HAS SET DELIVERY SCHEDULES, BUT ALSO HAS BROAD LEEWAY TO MISS THEM FOR A VARIETY OF REASONS.
Regulatory filings released to U.S. authorities
OTTAWA • Canada's agreement with COVID-19 vaccine manufacturer Novavax has been released in regulatory filings, showing the drug maker has set delivery schedules, but also has broad leeway to miss them for a variety of reasons.
Novavax was the fifth vaccine maker to submit their COVID-19 vaccine to Health Canada for approval and could be given the green light as early as April. The company has a deal to provide at least 52 million doses and as many as 76 million doses of its twodose vaccine to Canada.
All of Canada's seven vaccine contracts have been kept confidential since they were signed last year and the government has fought moves in Parliament to force the disclosure of the contracts. The released contract is still heavily redacted, with all the details on price, deliveries and penalties for missed timelines for Novavax blacked out.
The contract, filed with the U.S Securities and Exchange Commission on Monday, does specifically acknowledge there are many problems that could prevent the company from making its deliveries on time.
“Customer acknowledges that the delivery schedule may change due to several variables. Including but not limited to speed of clinical trial enrolment and accrual of events, manufacturing delays and/or timing of regulatory approval,” reads the contract. It also specifies the delivery schedule is an “estimate only.”
Under the deal, Novavax is set to deliver vaccines monthly to Canada and like other vaccine manufacturers has quarterly targets, though the specifics of those targets are redacted from the deal. The government agreed to pay up front for the vaccines, in part because the company agreed to manufacture doses ahead of regulatory approval so they can be moved out quickly after the vaccine is approved.
The company's CEO has said they could produce as many as 150 million doses per month starting in May.
They have also signed deals with the United Kingdom, United States and several other countries, but Canada is one of the biggest orders.
If Novavax misses targets it has the opportunity to catch up and if they continue to fail Canada has the ability to cancel the agreement. Canada paid an upfront payment, but it is unclear how much Canada would be out if it cancelled the contract.
The deal does specify the company has to make “commercially reasonable efforts” to deliver on the contract, a phrase, which also exists in the company's contracts with U.K. and Australia, though its specific definition is redacted.
On deliveries, the U.K. and Australia's contract includes similar language, but the U.K deal includes lots of specifics on the company's commitment to attempt to manufacture the vaccine in British facilities.
The company has also signed a deal to produce its vaccine on Canadian soil, at the National Research Council's under-construction facility in Montreal, but that was not part of
CUSTOMER ACKNOWLEDGES THAT THE DELIVERY SCHEDULE MAY CHANGE DUE TO SEVERAL VARIABLES.
the original agreement.
The Montreal facility is expected to take until late December to actually produce doses, and Canada's first shipments are expected to come from other countries.
The regulatory documents include the detail that the company is committed to go further and will expand its presence in Canada
“The MOU also includes a broader intention for the Government of Canada and us to work together to increase our Canadian presence,” reads the filing. “We will explore a range of partnership opportunities for us to expand vaccine production in Canada, including partnerships with Canadian contract manufacture.”