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Partnerships

Merck & Co., Inc. In November 2007, Dynavax and Merck & Co., Inc. announced a global license and development collaboration to jointly develop HEPLISAV, Dynavax’s novel investigational hepatitis B vaccine. Under the terms of the agreement, Merck receives worldwide exclusive rights to HEPLISAV, will fund future vaccine development, and be responsible for commercialization. Dynavax received an initial payment of $31.5 million, and is eligible to receive up to $105 million in development and sales milestone payments, as well as double-digit tiered royalties on global sales of HEPLISAV. Under Merck’s oversight, Dynavax is responsible for managing the remaining clinical development. The U.S. FDA Biologics Licensing Application (BLA) and other marketing applications will be the joint responsibility of the two companies, and will be filed by Merck. Dynavax will be responsible for the manufacture of the hepatitis B surface antigen component of the vaccine for Merck, which will be produced at Dynavax Europe’s facility in Dusseldorf, Germany.

Novartis Vaccines and Diagnostics, Inc. In July 2008, Dynavax announced a long-term collaboration with Novartis Vaccines and Diagnostics, Inc. for the development and commercialization of Dynavax’s novel Universal Influenza Vaccine. Under the agreement, Novartis is providing Dynavax a supply of trivalent influenza vaccine, an essential component of Dynavax’s Universal Influenza Vaccine, for both clinical trial use and vaccine sales. Novartis has received an exclusive option to negotiate a Joint Development and Commercialization Agreement with Dynavax. Under the agreement Dynavax will conduct early-stage development through a defined proof-of-concept. If Novartis exercises the right to expand the collaboration for further development and commercialization, Dynavax would retain co-commercialization rights in the U.S. and receive product royalties outside of the U.S.. Should the current collaboration not be expanded, Novartis remains committed to providing commercial supply of trivalent influenza vaccine at pre-agreed pricing and quantities and Dynavax retains the right to independently continue with late-stage development and commercialization.

AstraZeneca In September 2006, Dynavax entered into a research collaboration and license agreement with AstraZeneca (AZ) for the discovery and development of TLR9 agonist-based therapies for asthma and chronic obstructive pulmonary disease (COPD). The collaboration is focused on our proprietary second-generation TLR9 agonist ISS. Under the terms of the agreement, Dynavax and AZ are collaborating to identify TLR9 agonist-based approaches and conduct preclinical studies. Financial terms of the collaboration include an upfront fee of $10 million plus research funding and preclinical milestones that could bring the total committed funding to $27 million, resulting in a total potential deal value of approximately $136 million. AZ will be responsible for any development and worldwide commercialization of products arising from the program, and Dynavax may also have the opportunity to co-promote these products in the U.S. Upon commercialization, Dynavax is also eligible to receive royalties based on product sales.

Symphony Dynamo In April 2006, Dynavax initiated a collaborative financing agreement with Symphony Capital Partners, LP and its co-investors to provide $50 million of committed capital to advance our next-generation pipeline of TLR9 agonist ISS-based therapeutic programs in cancer, hepatitis B and hepatitis C through clinical development. This funding is enabling us to investigate seven new indications. Under the terms of the agreement, Symphony Capital, a private equity fund, established Symphony Dynamo, Inc. (SDI), which was capitalized initially with $20 million in 2006 and supplied an additional $30 million in April 2007 to fund Dynavax's identified development programs in cancer and hepatitis therapeutics. Dynavax has granted a license to the intellectual property for the ISS compounds selected for the Symphony Dynamo programs. Through a purchase option, Dynavax retains the exclusive right, but not the obligation, to acquire certain of the programs at specified points in time, or the entire set of funded programs at specified prices during the term of the development period. On May 1, 2007, Dynavax provided notice of exercise of its program option to reacquire rights to the hepatitis B therapy program, currently in a Phase 1 trial, making the SDI funding originally budgeted for this program available for the cancer and hepatitis C therapy programs. Dynavax will continue to develop the hepatitis B therapy outside of the SDI program. The term of the agreement is up to five years. While Symphony provides program support, Dynavax has retained rights to seek strategic partners for future development and commercialization.

National Institutes of Health (NIH) In late 2003, Dynavax was awarded a $3.0 million grant over three and a half years to fund research and development of a pandemic influenza vaccine under a program for biodefense administered by the National Institute of Allergy and Infectious Disease (NIAID), a division of the NIH. In August 2007, the NIAID extended this funding with the award of a two-year $3.25 million grant. Promising preclinical data were presented at two important scientific meetings in 2006: the Second International Conference on Influenza Vaccines for the World in Vienna, Austria, and the Conference on Novel Vaccines: Bridging Research, Development and Production, sponsored by the Cambridge Healthtech Institute. These data showed that the Dynavax flu vaccine was able to confer broad immunity across divergent flu strains. In addition, co-administration with standard vaccines was demonstrated to increase their effectiveness. These data suggest that the Dynavax vaccine has the potential to eliminate annual vaccinations and enable the stockpiling of vaccine for pandemic use. While NIH provides program support, we have retained rights to seek strategic partners for future development and commercialization.