DNDi – BioDelivery Sciences International, Visceral Leishmaniasis Research Collaboration Agreement

Liability | Insurance

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This Research and Development Agreement between the Drugs For Neglected Diseases Initiative (“DNDi”) and BioDelivery Sciences International, Inc. (“BDSI”), was signed on January 20, 2009. The agreement provides for collaboration between the parties to assess the efficiency of CAMB (a pharmaceutical formulation of Amphotericin B using BDSI’s intellectual property rights) in the treatment of visceral leishmaniasis.

The Parties will jointly conduct a Research and Development (R&D) Plan under which BDSI is responsible for making samples of CAMB available to DNDi in sufficient quantities for DNDi to conduct its activities. The parties will provide each other with the data and technical information reasonably required to conduct their respective activities under the R&D Plan. DNDi will appoint a program manager who will be responsible for the overall management of the plan.

Under the agreement, DNDi receives a license to use BDSI’s background IP and the collaboration IP to seek regulatory approvals and distribute the product for the treatment of African Human Trypanosomiasis (HAT), Chagas’ disease, and Visceral & Cutaneous Leishmaniasis (“Field”). The license grants are for all countries of the world excluding Japan, Australia, New Zealand, Russia, CIS countries, China, North America and the European Union (“Territory”), however DNDi’s rights to distribute CAMB are limited to the Public Sector within the Territory. The CAMB distributed by DNDi will be manufactured exclusively by BDSI, but DNDi may engage a secondary supplier if there is a shortfall in the quantities supplied by BDSI.

Provision Language

9. INDEMNIFICATION

[…]

9.4 Insurance. Each Party will maintain comprehensive general liability insurance coverage, including products liability coverage, in reasonable amounts that are appropriate with respect to its obligations and liabilities under this Agreement and will provide the other Party, if requested, with copies of its relevant insurance policies and evidence of payment of all insurance premiums due.

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