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Note 14 - Licensing Agreement
12 Months Ended
Dec. 31, 2012
Licensing Transaction [Text Block]
14. TECHNOLOGY DEVELOPMENT AND LICENSING AGREEMENTS

In the fourth quarter of 2008, the Company entered into a Development, Product Supply and Commercialization Agreement with Yakult Honsha under which Yakult was granted the exclusive right to commercialize and market ThermoDox® for the Japanese market.  We were paid a $2.5 million up-front licensing fee and we have the potential to receive additional payments from Yakult upon receipt of marketing approval by the Japanese Ministry of Health, Labor and Welfare as well as upon the achievement of certain levels of sales and approval for new indications. We will receive double digit escalating royalties on the sale ThermoDox® in Japan, when and if any such sales occur.  We also will be the exclusive supplier of ThermoDox® to Yakult.

Concurrent with the January 2011 Preferred Equity Financing as discussed in Note 9 to the Financial Statements, the Company amended its Development, Product Supply and Commercialization Agreement with Yakult to provide for up to $4.0 million in an accelerated partial payment to the Company of a future drug approval milestone, which included $2.0 million paid to the Company upon the closing of the preferred equity financing and an additional $2.0 million conditioned upon the resumption of enrollment of Japanese patients in the Japan cohort of the HEAT study.  In consideration of these accelerated milestone payments from Yakult, the Company agreed to reduce future drug approval milestone payments by approximately forty percent (40%).

In May 2012, the Company announced the signing of a long term commercial supply agreement with Zhejiang Hisun Pharmaceutical Co. Ltd. (Hisun) for the production of ThermoDox® in the China territory.  In accordance with the terms of the agreement, Hisun will be responsible for providing all of the technical and regulatory support services, including the costs of all technical transfer, registrational and bioequivalence studies, technical transfer costs, Celsion consultative support costs and the purchase of any necessary equipment and additional facility costs necessary to support capacity requirements for the manufacture of ThermoDox®.  Celsion will repay Hisun for the aggregate amount of these development costs and fees commencing on the successful completion of three registrational batches of ThermoDox®.  Hisun is also obligated to certain performance requirements under the agreement.  The agreement will initially be limited to a percentage of the production requirements of ThermoDox® in the China territory with Hisun retaining an option for additional global supply after local regulatory approval in the China territory.  In addition, Hisun will collaborate with Celsion around the regulatory approval activities for ThermoDox® with the China State Food and Drug Administration (SFDA).  As of December 31, 2012, the Company has incurred approximately $326,000 in costs to be reimbursed to Hisun.

On January 18, 2013, we entered into a technology development contract with Hisun, pursuant to which Hisun paid us a non-refundable research and development fee of $5.0 million to support our development of ThermoDox® and we will provide research data and other technical support in relation to a regulatory filing by Hisun with the SFDA for approval of ThermoDox® for manufacturing and sale in the China territory. On January 18, 2013, we also entered into an exclusive option agreement with Hisun, terminable at any time by Hisun, under which we granted Hisun an option to enter into an exclusive license agreement with us for the manufacturing and commercialization of ThermoDox® with respect to all indications in the China territory under the terms and conditions set forth in the exclusive option agreement and other customary terms and conditions to be set forth in the license agreement, if any. Hisun agreed to pay us an additional $5.0 million within sixty days after the signing of the exclusive option agreement if it has not been terminated within such time period. The exclusive option agreement contemplated payments of an upfront license fee, milestone payments and royalties to Celsion if the exclusive license agreement were entered into.

Following our announcement on January 31, 2013 that ThermoDox® in combination with radiofrequency ablation did not meet the primary endpoint of the Phase III clinical trial for primary liver cancer, Hisun has elected to terminate the exclusive option agreement and not to pursue the option to enter into an exclusive license agreement with us for the China territory, which termination took effect as of February 1, 2013. As a result of the termination, we will not receive the additional $5 million payment or any future payment originally contemplated by the exclusive option agreement. The technology development contract will remain in effect while we and Hisun continue to collaborate and are evaluating next steps in relation to ThermoDox®, which include the sub-group analysis of the Chinese cohort of patients in the HEAT study and other activities to further the development of ThermoDox® for the China territory.