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Note 6 - Commitments and Contingencies
License and Research Agreements
The Company has entered
into agreements with third parties for the rights to certain intellectual property, manufacturing and clinical trial services under
which the Company may incur obligations to make payments, including upfront payments, as well as milestone and royalty payments.
Notable inclusions in this category are:
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a. |
Oak Ridge National Laboratory ("ORNL") – The Company is contracted to purchase radioactive material to be used for research and development, with a renewal option at the contract end. During the years ended December 31, 2019 and 2018, the Company purchased material from ORNL of $0.2 million and $0.3 million, respectively. In November 2019, the Company signed a contract with ORNL to purchase $0.3 million of radioactive material during calendar year 2020. |
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b. |
On June 15, 2012, the Company entered into a license and sponsored research agreement with Fred Hutchinson Cancer Research Center ("FHCRC") to build upon previous and ongoing clinical trials with BC8 (licensed antibody). FHCRC has completed both a Phase 1 and Phase 2 clinical trial with BC8. The Company has been granted exclusive rights to the BC8 antibody and related master cell bank developed by FHCRC. A milestone payment of $1 million will be due to FHCRC upon FDA approval of the first drug utilizing the licensed BC 8 antibody. Upon commercial sale of the drug, royalty payments of 2% of net sales will be due to FHCRC. |
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c. |
On February 27, 2014, the Company entered into a manufacturing agreement with Goodwin Biotechnology Inc. ("Goodwin"). Goodwin oversees the current Good Manufacturing Practices ("cGMP") production of a monoclonal antibody used in the Phase 3 clinical trial of Iomab-B. As of December 31, 2019, the remaining cost of the service agreement is $0.3 million. During the years ended December 31, 2019 and 2018, the Company paid Goodwin $1.5 million and $1.2 million, respectively. |
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d. |
On February 16, 2016, the Company entered into an agreement with Medpace, Inc. ("Medpace"), a contract research organization. Medpace provides project management services for the Iomab-B study. In January 2020, the Company and Medpace amended their agreement. The total project is currently estimated to cost $11.9 million. Medpace bills the Company when services are rendered and the Company records the related expense to research and development costs. During the years ended December 31, 2019 and 2018, the Company paid Medpace $3.1 million and $3.1 million, respectively. These payments are for Medpace project management services and pass-through expenses incurred by investigators and clinical sites. |
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