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Note 6 - Licences, Royalty Agreements and Collaborative Arrangements
6 Months Ended
Dec. 31, 2012
Collaborative Arrangement Disclosure [Text Block]
(6)     Licenses, Royalty Collaborative and Contractual Arrangements

Royalty agreements

The Company entered into a royalty-bearing research and license agreement with GSK in 1990 for the development and commercialization of zanamivir, a neuraminidase inhibitor (NI) marketed by GSK as RelenzaTM to treat influenza. Under the terms of the agreement, the Company licensed zanamivir to GSK on an exclusive, worldwide basis and is entitled to receive royalty payments of 7% of GSK's annual net sales of RelenzaTM in the U.S., Europe, Japan and certain other countries as well as 10% of GSK's annual net sales of RelenzaTM in Australia, New Zealand, South Africa and Indonesia. Royalties earned by the Company under this agreement for the three month period ending December 31, 2012 and 2011, were $1.0 million and $(1.6) million, respectively, and royalties earned for the six month period ending December 31, 2012 and 2011 were $1.0 million and $0.7 million, respectively. Beginning in 2014, the patents on RelenzaTM will begin to expire in certain countries and are scheduled to fully expire in 2019.

The Company also generates royalty revenue from the sale of Inavir® in Japan, pursuant to a collaboration and license agreement that the Company entered into with Daiichi Sankyo related to the development and commercialization of second generation, long-acting NI’s ("LANI"), including laninamivir octanoate. In September 2010, laninamivir octanoate was approved for sale by the Japanese Ministry of Health and Welfare for the treatment of influenza in adults and children, which Daiichi Sankyo markets as Inavir®. Under the agreement, the Company currently receives a 4% royalty on net sales of Inavir® in Japan. Royalties earned by the Company under this agreement for the three month periods ending December 31, 2012 and 2011, were $0.9 million and $0.5 million, respectively, and royalties earned for the six month periods ending December 31, 2012 and 2011 were $0.9 million and $0.7 million, respectively. Under the collaboration and license agreement, the Company and Daiichi Sankyo co-own the related intellectual property, and have agreed to share equally in any royalties, license fees, or milestone or other payments received from any third party licenses outside of Japan, the specific terms of which have yet to be finalized. Patents on laninamivir octanoate in Japan generally expire in 2027.

Collaborative and contract arrangements

On March 31, 2011, the Company’s wholly owned subsidiary, Biota Scientific Management Pty Ltd., was awarded a contract by the U.S. Office of Biomedical Advanced Research and Development Authority (“BARDA”). BARDA is part of the U.S. Office of the Assistant Secretary for Preparedness and Response ("ASPR") within the U.S. Department of Health and Human Services ("HHS"). The BARDA contract is for the late-stage development of laninamivir octanoate on a cost-plus-fixed-fee basis, the total of which is not to exceed $231.2 million. Pursuant to the BARDA contract, reimbursable costs include, but are not limited to, those incurred by the Company for clinical development, scale-up, formulation and manufacture leading to the potential licensure of laninamivir octanoate by the FDA. The BARDA contract is designed to fund and provide the Company with technical and clinical data, and U.S. based manufacturing to support the filing of a U.S. new drug application ("NDA") with the FDA for laninamivir octanoate. The performance period of the BARDA contract commenced on March 31, 2011, and continues for five years.

The Company is considered an active participant in the BARDA contract, with exposure to significant risks and rewards of commercialization relating to the development of laninamivir octanoate. Therefore, revenues from the contract and costs associated with the contract are recorded and recognized on a gross basis in the consolidated statement of operations.

Revenue earned by the Company under the BARDA contract for the three month periods ending December 31, 2012 and 2011, were $7.9 million and $3.1 million, respectively, and revenue earned for the six month periods ending December 31, 2012 and 2011 were $9.2 million and $4.5 million, respectively. Revenue totaling $18.4 million has been recognized to-date pursuant to this contract.