| Commitments and Contingencies |
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:
|
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, 2018, 2017 and 2016, the Company purchased material from ORNL of approximately $0.3 million, $0.6 million and $1.0
million, respectively. On December 19, 2018, the Company signed a contract with ORNL to purchase $0.2 million of radioactive material
during calendar year 2019. |
|
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 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. |
|
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, 2018, the remaining cost of the service agreement is
$1.0 million. During the years ended December 31, 2018, 2017 and 2016, the Company paid Goodwin $1.2 million, $1.4 million and
$0.7 million, respectively. |
|
d. |
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 approximately $10.2 million. As of December 31, 2018, the remaining cost of the agreement
is approximately $3.3 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, 2018, 2017 and 2016, the Company paid Medpace $3.1 million,
$2.8 million and $2.6 million, respectively. |
|
e. |
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. As of December 31, 2018, the remaining cost of the agreement is approximately $0.5
million. George 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, 2018, 2017 and 2016, the Company paid George $1.9 million, $0.7 million and $0.1 million,
respectively. |
Lease Agreements
The Company does not
own any real property. It currently leases office space located at 275 Madison Avenue, New York, NY. The lease is for 5,790 square
feet and has a term of seven years and three months, with an expiration date of September 6, 2022, with a current annual rate of
$312,660 until June 8, 2019 and $341,610 for the remaining life of the lease. The Company is also responsible for certain other
costs, such as insurance, taxes, utilities, and maintenance. The Company issued a letter of credit of $390,825 in connection with
the lease and maintained a $391,131 certified deposit as collateral for the letter of credit.
In 2017, the Company
also entered into a license agreement for furniture and fixtures located at its office space. Pursuant to the terms of the agreement,
the Company leases the furniture and fixtures and tenant improvements located in the office space for the same term as the office
space for $7,529 per month. At any time during the term of this amended agreement, the Company has the right to purchase the furniture,
and fixtures.
In December 2018,
the Company entered into a five-year lease agreement for office equipment and services for $906 per month and the capitalized value
associated with the lease agreement was $16,078.
Future minimum obligations
on all of the Company’s operating leases with a term over one year are:
| For the year ending December 31: |
|
|
|
| 2019 |
|
$ |
419,896 |
|
| 2020 |
|
|
431,958 |
|
| 2021 |
|
|
431,958 |
|
| 2022 |
|
|
287,972 |
|
| Total |
|
$ |
1,571,784 |
|
|