Early July 2020 saw Emergent enter into a manufacturing services deal with Janssen Pharmaceuticals for large-scale drug substance manufacturing of J&J's investigational COVID-19 vaccine.
The termination notice, according to Reuters, comes about a week after J&J had initially informed Emergent of its intent to end the arrangement, with the drug maker citing what it termed the CDMO’s contract breaches, including failure by Emergent to perform its obligations in compliance with current good manufacturing practices (cGMP) or other applicable laws and regulations and its failure to supply Janssen with the product.
In a SEC filing yesterday, Emergent said that J&J breached an agreement by failing to buy the minimum quantity of COVID-19 vaccines made by the company. The contract manufacturer added that J&J had failed to provide required forecasts for the amount of vaccines it needed and had wound down the agreement instead of fulfilling minimum requirements.
J&J, as per an article in the Wall Street Journal, called that Emergent filing "false and misleading."
If the agreement is terminated, Emergent said J&J would owe it roughly $125 million to $420 million.
In 2021, a manufacturing mishap at an Emergent plant in Baltimore rendered millions of Janssen COVID doses unusable.
Meanwhile, the use of J&J's COVID-19 vaccine has been stalled in the US after the Food and Drug Administration (FDA) in May significantly restricted its use due to safety concerns.