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TECHNOLOGY DEVELOPMENT AND LICENSING AGREEMENTS
12 Months Ended
Dec. 31, 2023
Technology Development And Licensing Agreements  
TECHNOLOGY DEVELOPMENT AND LICENSING AGREEMENTS

18. TECHNOLOGY DEVELOPMENT AND LICENSING AGREEMENTS

 

On May 7, 2012, the Company entered into a long-term commercial supply agreement with Zhejiang Hisun Pharmaceutical Co. Ltd. (“Hisun”) for the production of ThermoDox® in mainland China, Hong Kong and Macau (the “China territory”). In accordance with the terms of the agreement, Hisun is responsible for providing all of the technical and regulatory support services, including the costs of all technical transfer, registration and bioequivalence studies, technical transfer costs, Imunon consultative support costs and the purchase of any necessary equipment and additional facility costs necessary to support capacity requirements for the manufacture of ThermoDox®. Imunon is obligated to repay Hisun for the aggregate amount of these development costs and fees commencing on the successful completion of three registration batches of ThermoDox®. Hisun is also obligated to meet certain performance requirements under the agreement. The agreement was initially 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, the agreement provided that Hisun would collaborate with Imunon around the regulatory approval activities for ThermoDox® with the China State Food and Drug Administration.

 

On January 18, 2013, the Company entered into a technology development contract with Hisun, pursuant to which Hisun paid Imunon a non-refundable research and development fee of $5 million to support development of ThermoDox® in the China territory. Following the Company’s announcement on January 31, 2013 that the HEAT study failed to meet its primary endpoint, Imunon and Hisun agreed that the Technology Development Contract entered into on January 18, 2013 would remain in effect while the parties continued to collaborate and evaluate the next steps in relation to ThermoDox®, which include the sub-group analysis of patients in the Phase III HEAT Study for the HCC clinical indication and other activities to further the development of ThermoDox® for the Greater China market. The $5.0 million received as a non-refundable payment from Hisun in the first quarter 2013 was recorded to deferred revenue and was amortized over the 10-year term of the agreement, until such time as the parties would find a mutually acceptable path forward on the development of ThermoDox® based on findings of the ongoing post-study analysis of the HEAT study data. The Hisun agreement has expired.