| Commitments and Contingencies |
Note
3 - Commitments and Contingencies
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:
| a. |
MSKCC
- On February 11, 2002, the Company entered into a License, Development and Commercialization Agreement with Sloan-Kettering
Institute of Cancer Research (“SKI”), an entity related to Memorial Sloan-Kettering Cancer Institute, Inc. (“MSKCC”). The
agreement was amended in August 2006. Pursuant to the agreement, the Company licensed certain intellectual property
from SKI, including critical patents with respect to the Company’s core technology that also supports ongoing research and
clinical development of related drug candidates. MSKCC agreed, subject to certain conditions, to utilize the funds
paid for certain clinical and preclinical programs and activities related to the Company’s drug development and clinical
study programs, including the payment of certain costs and expenses that would otherwise have been borne by the Company. |
The
Company is obligated to make the following milestone payments:
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Milestones |
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Payments |
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(1) filing of a New Drug Application (“NDA”) or regulatory approval for each licensed product |
|
$ |
750,000 |
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(2) upon the receipt of regulatory approval from the U.S. FDA for each licensed product |
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1,750,000 |
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Under
the agreement, the Company shall pay to MSKCC on a country-by-country basis a royalty of 2% of net sales of all licensed products
until the later of: (1) 10 years from the first commercial sale, or (2) when the patents expire.
For
the six months ended June 30, 2018 and 2017, respectively, the Company incurred $0.1 million for maintenance fees and research
conducted by MSKCC.
| b. |
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. On December 13, 2017, the Company signed a contract
with ORNL to purchase $0.2 million of radioactive material during calendar year 2018. During the six months ended June 30,
2018 and 2017, the Company purchased material from ORNL of approximately $0.1 million and $0.3 million, respectively. |
| c. |
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 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. Upon commercial sale of the drug, royalty payments of 2% of net sales will be due to FHCRC. For the six
months ended June 30, 2018 and 2017, the Company incurred expenses of $0 and $44,000, respectively, related to this agreement. |
| d. |
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 June 30, 2018, the remaining cost of the service agreement is approximately
$1.5 million. For each of the six months ended June 30, 2018 and 2017, the Company paid Goodwin $0.8 million and $0.3 million,
respectively. |
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| e. |
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. The total project is estimated to cost approximately
$7.2 million. Medpace bills the Company when services are rendered and the Company records the related expense to research
and development costs. For the six months ended June 30, 2018 and 2017, the Company paid Medpace $1.5 million and $1.4 million,
respectively. |
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|
| f. |
On
August 4, 2016, the Company entered into a CRO agreement with George Clinical Services, (“George”). George provides
project management services for the study of Actimab-A used for a Phase 2 clinical trial. The total project is estimated
to cost approximately $4.6 million. For the six months ended March 31, 2018 and 2017, the Company paid George $0.7 million
and $0.2 million, respectively. |
Collaborative
Agreement
In 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.
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