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Agreements

Date: 2014-08-26

Type of information: Services contract

Compound: Imvamune® smallpox vaccine

Company: Bavarian Nordic (Denmark) Canadian Government (Canada)

Therapeutic area: Infectious diseases

Type agreement:

services

Action mechanism:

Disease: smallpox

Details:

* On November 11, 2012, Bavarian Nordic has announced that the Canadian Government, through exercise of an option under an ongoing contract, has ordered 20,000 doses of Imvamune® smallpox vaccine to replace the current stockpile, that was delivered in 2009. Since 2008, Bavarian Nordic has collaborated with the Canadian Government to address their biological preparedness requirements. The company was initially awarded a contract to supply 20,000 doses of Imvamune® to the Canadian armed forces. Also, the contract provided milestone-based funding for the filing of a New Drug Substance application for Imvamune® for use in the general population. The NDS was filed in 2011 and is currently under review by Health Canada with anticipated decision in the first half of 2013.

Financial terms:

Due to the new order and reimbursement of costs related to the licensing of Imvamune® in Canada, the company raises its financial expectations for the year. Revenues are raised from approximately DKK 975 million to approximately DKK 1 billion and the result before tax is improved by DKK 20 million from a loss of approximately DKK 70 million to a loss of approximately DKK 50 million. The cash preparedness at year-end is now expected to be approximately DKK 540 million against previously approximately DKK 525 million, including a credit facility of DKK 120 million.

Latest news:

* On August 26, 2014, Bavarian Nordic announced that it has signed two contracts with the Canadian authorities for the delivery of a total of 65,700 doses of Imvamune® smallpox vaccine. The vaccines will be delivered in 2014 and 2015. This will bring the current number of delivered doses of Imvamune® to Canada above 100,000 doses. Following a public tender, the Public Health Agency of Canada has awarded Bavarian Nordic a contract to deliver 45,700 doses of Imvamune® with the option to deliver an additional 314,300 doses. This contract represents the first commercial contract awarded by the Canadian authorities to Bavarian Nordic after receiving approval of Imvamune® by Health Canada in 2013.

Secondly, the Canadian Department of National Defence, through exercise of an option under an ongoing contract, has ordered 20,000 doses of Imvamune® smallpox vaccine to replace the current stockpile for the Canadian Armed Forces. This contract was awarded in 2008 with initial deliveries of 20,000 doses in 2009, followed by a replacement order in 2012. Under this contract, an option of an additional 140,000 doses remains.

Is general: Yes