Quarterly report pursuant to Section 13 or 15(d)

Commitments and Contingencies

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Commitments and Contingencies
9 Months Ended
Sep. 30, 2015
Commitments and Contingencies [Abstract]  
Commitments and Contingencies

Note 7 - Commitments and Contingencies

 

License and Research Agreements

 

The Company has entered into license and research and development agreements with third parties under which the Company is obligated to make upfront payments as well as milestone and royalty payments. Notable inclusions in this category are:

 

a. AbbVie Biotherapeutics Corp. (formerly Abbott Biotherapeutics Corp) - The Company entered into a Product Development and Patent License Agreement with AbbVie Biotherapeutics Corp. in 2003 to secure exclusive rights to a specific antibody when conjugated with alpha emitting radioisotopes. Upon execution of the agreement, the Company made a license fee payment of $3,000,000.

 

The Company agreed to make milestone payments totaling $7,750,000 for the achievement of the following agreed to and contracted milestones:

 

Milestones   Payments  
       
(1) when Company initiates a Phase 1 Clinical Trial of a licensed product   $ 750,000  
(2) when Company initiates a Phase 2 Clinical Trial of a licensed product     750,000  
(3) when Company initiates a Phase 3 Clinical Trial of a licensed product     1,500,000  
(4) Biological License Application filing with U.S. FDA     1,750,000  
(5) First commercial sale     1,500,000  
(6) after the first $10,000,000 in net sales     1,500,000  

 

Under the agreement, the Company shall pay to AbbVie Biotherapeutics Corp. on a country-by-country basis a royalty of 12% of net sales of all licensed products until the later of: (1) 12.5 years after the first commercial sale, or (2) when the patents expire.

 

The Company met its first milestone in 2012 and upon reaching the milestone the Company paid AbbVie Biotherapeutics Corp. a milestone payment of $750,000 on July 24, 2012.  The milestone payment for the Phase 1 Clinical Trial was recorded as research and development expense. The Company has not initiated a Phase 2 Clinical Trial and no payment has been made to AbbVie Biotherapeutics Corp. since the July 24, 2012 payment.

 

b. MSKCC - see Note 2 - Related Party Transactions.

 

c.

AptivSolutions provides project management services for the study of the drug Ac-225-HuM195 (Actimab-A) used in the Company’s Phase 1 and Phase 2 clinical trials.  The total project was estimated to cost approximately $1.9 million and required a 12.5% down payment of the total estimated project cost.  The down payment totaling $239,000 was paid in 2007 and 2012.  On August 6, 2012, October 22, 2012 and May16, 2013, the agreement was amended to provide for additional services.  The total project is now estimated at approximately $2.7 million. AptivSolutions invoices the Company when services are rendered and the Company records the related expense to research and development expense.

 

For nine months ended September 30, 2015 and 2014, the Company incurred expenses of approximately $0.5 million and $0.3 million, respectively, related to this agreement.

   

d.

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 and the Company intends to start preparation for a pivotal trial leading to an FDA approval. The Company has been granted exclusive rights to the BC8 antibody and related master cell bank developed by FHCRC. The cost to develop the trial will range from $13.2 million to $23.5 million, depending on the trial design as required by the FDA. Under the terms of the sponsored research agreement, the Company will fund the FHCRC lab with $150,000 per year for the first two years and $250,000 thereafter. Payments made toward funding the lab will be credited toward royalty payments owed to FHCRC in the given year. 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 nine months ended September 30, 2015 and 2014, the Company incurred expenses of approximately $0.2 million and $0.1 million, respectively, related to this agreement.

 

e. On August 28, 2012, the Company entered into a clinical trial agreement with The University of Texas M.D. Anderson Cancer Center.  The total estimated cost of conducting the clinical trial is approximately $500,000, which includes a non-refundable institutional fee of $14,500.  The estimated cost is based on treating 24 patients through 2015.  Upon execution of the agreement, the Company paid $33,946. There were no expenses recorded during the three or nine months ended September 30, 2015. During the three and nine months ended September 30, 2014, the Company recorded an expense of approximately $0.1 million.
   
f.   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 anticipated to be used in an upcoming phase 3 clinical trial of Iomab-B. Total cost of the agreement is $5.0 million. The Company made a non-refundable payment of $562,790 upon execution of the agreement. Periodic payments will be made upon reaching certain milestones. As of September 30, 2015, the remaining cost of the agreement is approximately $1.7 million. Goodwin bills the Company when services are rendered and the Company records the related expense to research and development costs. For the nine months ended September, 2015 and 2014, the Company paid Goodwin approximately $3.9 million and $2.0 million, respectively. As of September 30, 2015 and December 31, 2014, the Company owed $0.1 million and $0.8 million, respectively, to Goodwin.
   
g.   On September 30, 2014, the Company entered into a research agreement with the Albert Einstein College of Medicine of Yeshiva University (“Einstein”). According to the agreement, Einstein will use certain materials provided by the Company to complete a research project. The research project will explore the feasibility of using Actinium 225 to prepare patients with blood borne cancers to receive a hematopoietic stem cell transplant. Einstein will periodically provide the Company with reports showing project data or research. The total fixed price of the project is $183,391 which is payable to Einstein in three payments. During the nine months ended September 30, 2015 and 2014, the Company paid Einstein approximately $55,000 and $0, respectively. No payments were made during the third quarter of 2015. As of September 30, 2015, the Company paid Einstein a total of $146,713.

 

Lease Agreements

 

On June 30, 2015, July 1, 2015 and October 1, 2015, the Company entered into three separate three-month rental agreements for office space at 757 3rd Avenue, New York, NY. The Company paid a one month refundable deposit on the space that it maintains in New York, NY.  

 

On April 22, 2014, the Company entered into a sublease agreement for office space located at 379 Thornall Street, Edison, NJ. This agreement expires on September 30, 2016. The Company issued a letter of credit for $34,733 to the existing tenant and maintained a $34,733 certified deposit as collateral for the letter of credit.

 

Future minimum obligations on the lease are:

 

For the year ending September 30, 2016   $ 112,015  
Total   $ 112,015