|Commitments and Contingencies
2 - Commitments and Contingencies
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:
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. On December 19, 2018, the Company signed a contract
with ORNL to purchase $0.2 million of radioactive material during calendar year 2019. During the nine months ended September
30, 2019 and 2018, the Company purchased material from ORNL of approximately $0.2 million in each period.
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 currently
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.
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 September 30, 2019, the remaining cost of the service agreement is $0.3
million. For the nine months ended September 30, 2019 and 2018, the Company paid Goodwin $1.5 million and $1.0 million, respectively.
February 16, 2016, the Company entered into an agreement with Medpace, Inc. ("Medpace"), a Contract Research Organization,
("CRO"). Medpace provides project management services for the Iomab-B study. The total project is currently estimated
to cost approximately $10.2 million. As of September 30, 2019, the remaining cost of the agreement is approximately $0.9 million.
Medpace bills the Company when services are rendered and the Company records the related expense to research and development
costs. During the nine months ended September 30, 2019 and 2018, the Company paid Medpace $2.0 million and $2.6 million, respectively. These
payments are for Medpace project management services and pass-through expenses incurred by investigators and clinical sites.
March 2018, the Company entered into a research and option agreement with Astellas Pharma Inc. ("Astellas") to develop
ARC's using the Company's AWE Technology Platform. Under this collaboration, the Company will utilize its AWE Platform
to conjugate and label selected Astellas targeting agents with an Actinium-225 payload. The Company will also be responsible for
conducting preclinical validation studies on any ARCs generated. Payments from Astellas under this agreement are accounted
for as a reduction to research and development expense.