|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 three months ended March
31, 2019 and 2018, the Company purchased material from ORNL of $0.1 million.
June 15, 2012, the Company entered into a license and sponsored research agreement with Fred Hutchinson Cancer Research
Center ("FHCRC") for BC8 (licensed antibody), the antibody used in our Iomab-B and Iomab-ACT programs. The
Company has been granted exclusive rights to any products or process which utilizes the master cell bank or the BC8
monoclonal antibody, the master cell bank and related documentation, BC8 antibody manufacturing documentation and all
clinical, preclinical and technical data owned or controlled by FHCRC related to the BC8 program. 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. In addition, Goodwin is also conducting manufacturing activity to support a potential
BLA filing. For the three months ended March 31, 2019 and 2018, the Company paid Goodwin $0.9 million and $0.4 million, respectively.
||On 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 $10.2 million. As of March 31, 2019, the remaining cost of the agreement is $3.1 million.
Medpace bills the Company when services are rendered and the Company records the related expense to research and development costs.
For the three months ended March 31, 2019 and 2018, the Company paid Medpace $0.4 million and $0.6 million, respectively.
March 2018, the Company entered into a research and option agreement with Astellas Pharma Inc. ("Astellas") to develop
ARCs using the Company's AWE Platform Technology. 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.