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Commitments and Contingencies
12 Months Ended
Dec. 31, 2015
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies

9. Commitments and Contingencies

 

The Company is not currently subject to any pending or threatened legal actions or claims.

 

Significant agreements and contracts are summarized as follows:

 

On September 21, 2012, the Company entered into a work order agreement with Theradex, the CRO responsible for the clinical development of the Company’s lead compound, LB-100, to manage and administer the Phase 1 clinical trial of LB-100. The Phase 1 clinical trial of LB-100, which began during April 2013 with the entry of patients into the clinical trial, is being carried out by nationally recognized comprehensive cancer centers, and is estimated to be completed by May 31, 2016. The Phase 1 clinical trial is currently estimated to cost approximately $2,200,000, with such payments expected to be allocated approximately 60% for services provided by Theradex and approximately 40% for pass-through costs for clinical center laboratory costs and investigator costs over the life of the clinical trial. Total costs charged to operations through December 31, 2015 for services paid to or through Theradex pursuant to this arrangement, which were first incurred in 2013, aggregated $1,660,725, of which $958,896 and $423,108 were incurred during the years ended December 31, 2015 and 2014, respectively. Costs pursuant to this agreement are included in research and development costs in the Company’s consolidated statements of operations.

 

On December 24, 2013, the Company entered into an agreement with NDA Consulting Corp. (“NDA”) for consultation and advice in the field of oncology research and drug development. As part of the agreement, NDA also agreed to cause its president, Dr. Daniel D. Von Hoff, M.D., to become a member of the Company’s Scientific Advisory Committee. The term of the agreement was for one year and provided for a quarterly cash fee of $4,000. The agreement was automatically renewed on its anniversary date for an additional one-year term. Consulting and advisory fees charged to operations pursuant to this agreement were $16,000 during the years ended December 31, 2015 and 2014.

 

Effective January 1, 2014, the Company entered into an Advisory Agreement with Dr. Kathleen P. Mullinix, a member of the Board of Directors of the Company, effective for an initial term of one year through December 31, 2014 to advise on business development matters. The Advisory Agreement provided for annual cash compensation of $25,000. The term of the Advisory Agreement was automatically extended for a term of one year annually unless a notice of intent to terminate was given by either party at least 90 days before the end of the applicable term. Accordingly, the Advisory Agreement was extended for additional terms of one year effective January 1, 2015 and 2016. The Company recognized a charge to operations of $25,000 as consulting and advisory fees pursuant to this Advisory Agreement during the years ended December 31, 2015 and 2014.

 

On October 7, 2014, the Company entered into an agreement with ProActive Capital Resources Group LLC for strategic advisory, investor relations and public relations services through October 6, 2015. Among other things, the agreement provided for compensation in the form of a monthly fee of $1,500 in cash. Fees charged to operations pursuant to this agreement and other arrangements were $13,500 and $12,000 during the years ended December 31, 2015 and 2014, respectively.

 

Effective September 14, 2015, the Company entered into a Collaboration Agreement with BioPharmaWorks, pursuant to which the Company engaged BioPharmaWorks to perform certain services for the Company. Those services include, among other things: (a) assisting the Company to (i) commercialize its products and strengthen its patent portfolio, (ii) identify large pharmaceutical companies with potential interest in the Company’s product pipeline, and (iii) prepare and deliver presentations concerning the Company’s products; (b) at the request of the Board of Directors, serving as backup management for up to three months should the Company’s Chief Executive Officer and scientific leader be temporarily unable to carry out his duties; (c) being available for consultation in drug discovery and development; and (d) identifying providers and overseeing tasks relating to clinical use and commercialization of new compounds. BioPharmaWorks was founded in 2015 by former Pfizer scientists with extensive multi-disciplinary research and development and drug development experience. The Collaboration Agreement is for an initial term of two years and automatically renews for subsequent annual periods unless terminated by a party not less than 60 days prior to the expiration of the applicable period. In connection with the Collaboration Agreement, the Company agreed to pay BioPharmaWorks a monthly fee of $10,000, subject to the right of the Company to pay a negotiated hourly rate in lieu of the monthly payment, and agreed to issue to BioPharmaWorks certain equity-based compensation as described at Note 7. Fees charged to operations pursuant to this Collaboration Agreement and other arrangements were $52,625 during the year ended December 31, 2015.

 

The following table sets forth the Company’s principal cash obligations and commitments for the next five fiscal years as of December 31, aggregating $713,927, of which $124,050 is included in current liabilities in the Company’s consolidated balance sheet at December 31, 2015.

 

          Payments Due By Year  
    Total     2016     2017     2018     2019     2020  
                                     
Research and development contracts   $ 409,703     $ 409,703     $     $     $     $  
Clinical trial agreements     48,224       48,224                          
Consulting agreements     256,000       166,000       90,000                    
Total   $ 713,927     $ 623,927     $ 90,000     $     $     $