0001168220-15-000076.txt : 20150814 0001168220-15-000076.hdr.sgml : 20150814 20150814160925 ACCESSION NUMBER: 0001168220-15-000076 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 12 CONFORMED PERIOD OF REPORT: 20150630 FILED AS OF DATE: 20150814 DATE AS OF CHANGE: 20150814 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ULURU Inc. CENTRAL INDEX KEY: 0001168220 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 412118656 STATE OF INCORPORATION: NV FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-33618 FILM NUMBER: 151055828 BUSINESS ADDRESS: STREET 1: 4452 BELTWAY DRIVE CITY: ADDISON STATE: TX ZIP: 75001 BUSINESS PHONE: 214-905-5145 MAIL ADDRESS: STREET 1: 4452 BELTWAY DRIVE CITY: ADDISON STATE: TX ZIP: 75001 FORMER COMPANY: FORMER CONFORMED NAME: ULURU INC. DATE OF NAME CHANGE: 20060417 FORMER COMPANY: FORMER CONFORMED NAME: OXFORD VENTURES INC DATE OF NAME CHANGE: 20020225 10-Q 1 form10q_063015.htm FORM 10-Q 06/30/2015 form10q_063015.htm


 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-Q

[X] Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

For the quarterly period ended: June 30, 2015

OR

[_] Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

For the transition period from: ___ to ___.

Commission File Number: 001-336180

ULURU Inc.
(Exact Name of Registrant as Specified in its Charter)

Nevada
41-2118656
(State or Other Jurisdiction of
(I.R.S. Employer Identification No.)
Incorporation or Organization)
 

4452 Beltway Drive
Addison, Texas
75001
(Address of Principal Executive Offices)
(Zip Code)

(214) 905-5145
Registrant's Telephone Number, including Area Code

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  þ    No  o

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
    Yes  þ    No  o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company.  See the definitions of “large accelerate filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b-2 of the Exchange Act.  (Check one):

Large accelerated filer o
Accelerated filer o
Non-accelerated filer o
Smaller reporting company þ


Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes  o    No  þ

As of August 14, 2015, there were 24,819,534 shares of the registrant’s Common Stock, $0.001 par value per share (“Common Stock”), and no shares of Series A Preferred Stock, $0.001 par value per share, issued and outstanding.

 
 

 



INDEX TO FORM 10-Q

For the Quarter Ended JUNE 30, 2015

   
Page
 
     
     
 
 
 
 
     
     
     
     
 
     
     
     
     
     
     
     
     
 
     
     
     
     



PART I – FINANCIAL INFORMATION


ITEM 1.
Financial Statements.

ULURU Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
   
June 30, 2015
   
December 31, 2014
 
   
(Unaudited)
   
(Audited)
 
ASSETS
           
Current Assets
           
Cash and cash equivalents
  $ 19,296     $ 550,458  
Accounts receivable, net
    2,381       3,879  
Accounts receivable – related party, net
    1,249,683       798,147  
Inventory
    538,187       325,657  
Prepaid expenses and deferred charges
    60,713       137,858  
Total Current Assets
    1,870,260       1,815,999  
                 
Property, Equipment and Leasehold Improvements, net
    328,370       432,110  
                 
Other Assets
               
Intangible assets, net
    2,960,067       3,195,689  
Investment in unconsolidated subsidiary
    ---       ---  
Deposits
    18,069       18,069  
Total Other Assets
    2,978,136       3,213,758  
                 
TOTAL ASSETS
  $ 5,176,766     $ 5,461,867  
                 
LIABILITIES AND STOCKHOLDERS' EQUITY
         
Current Liabilities
               
Accounts payable
  $ 1,986,356     $ 1,536,612  
Accrued liabilities
    327,001       273,201  
Accrued interest
    11,764       ---  
Promissory notes payable, net of unamortized debt discount and debt issuance costs, current portion
    405,275       ---  
Deferred revenue, current portion
    64,100       58,959  
Total Current Liabilities
    2,794,496       1,868,772  
                 
Long Term Liabilities
               
Promissory notes payable, net of unamortized debt discount, debt issuance costs, and current portion
    44,728       ---  
Deferred revenue, net of current portion
    841,435       839,174  
Total Long Term Liabilities
    886,163       839,174  
                 
TOTAL LIABILITIES
    3,680,659       2,707,946  
                 
COMMITMENTS AND CONTINGENCIES
    ---       ---  
                 
STOCKHOLDERS' EQUITY
               
                 
Preferred stock - $0.001 par value; 20,000 shares authorized;
               
Preferred Stock Series A, 1,000 shares designated; no shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively
    ---       ---  
                 
Common Stock - $0.001 par value; 200,000,000 shares authorized;
               
24,819,534 and 24,458,018 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively
    24,820       24,458  
Additional paid-in capital
    56,499,358       56,289,882  
Accumulated  (deficit)
    (55,028,071 )     (53,560,419 )
TOTAL STOCKHOLDERS’ EQUITY
    1,496,107       2,753,921  
                 
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
  $ 5,176,766     $ 5,461,867  
                 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
 



ULURU Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)


   
Three Months Ended June 30,
   
Six Months Ended June 30,
 
   
2015
   
2014
   
2015
   
2014
 
Revenues
                       
License fees
  $ 15,979     $ 14,698     $ 30,518     $ 29,237  
Royalty income
    ---       17,012       ---       17,012  
Product sales, net
    243,018       177,584       523,127       265,026  
Total Revenues
    258,997       209,294       553,645       311,275  
                                 
Costs and Expenses
                               
Cost of product sold
    81,286       113,090       182,816       154,132  
Research and development
    219,335       184,423       423,494       372,019  
Selling, general and administrative
    495,034       411,279       941,191       880,352  
Amortization of intangible assets
    118,461       118,461       235,622       235,622  
Depreciation
    46,218       59,553       104,527       120,107  
Total Costs and Expenses
    960,334       886,806       1,887,650       1,762,232  
Operating (Loss)
    (701,337 )     (677,512 )     (1,334,005 )     (1,450,957 )
                                 
Other Income (Expense)
                               
Interest and miscellaneous income
    69       519       211       5,060  
Interest (expense) income
    (63,185 )     (32,722 )     (76,154 )     2,969  
Equity in earnings (loss) of unconsolidated subsidiary
    ---       ---       ---       ---  
Foreign currency transaction gain (loss)
    35,074       ---       (57,704 )     ---  
Loss on early extinguishment of convertible note
    ---       ---       ---       (135,078 )
(Loss) Before Income Taxes
    (729,379 )     (709,715 )     (1,467,652 )     (1,578,006 )
                                 
Income taxes
    ---       ---       ---       ---  
Net (Loss)
  $ (729,379 )   $ (709,715 )   $ (1,467,652 )   $ (1,578,006 )
                                 
                                 
Basic and diluted net (loss) per common share
  $ (0.03 )   $ (0.03 )   $ (0.06 )   $ (0.07 )
                                 
Weighted average number of common shares outstanding
    24,767,889       24,122,176       24,613,809       22,776,695  
                                 
The accompanying notes are an integral part of these consolidated financial statements.
 



ULURU Inc.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)

   
Six Months Ended June 30,
 
   
2015
   
2014
 
OPERATING ACTIVITIES :
           
Net loss
  $ (1,467,652 )   $ (1,578,006 )
                 
Adjustments to reconcile net loss to net cash used in operating activities:
               
                 
Amortization of intangible assets
    235,622       235,622  
Depreciation
    104,527       120,107  
Share-based compensation for stock and options issued to employees
    24,933       9,276  
Share-based compensation for options issued to non-employees
    120,253       37,647  
Equity in earnings (loss) of unconsolidated subsidiary
    ---       ---  
Amortization of debt discount on convertible note
    ---       (78,630 )
Amortization of debt discount on promissory note
    11,035       ---  
Amortization of debt issuance costs
    8,103       7,309  
Warrants issued (cancelled) for services
    ---       72,771  
Common stock issued for services
    ---       42,600  
Common stock issued for interest due on convertible note
    ---       2,063  
Loss on early extinguishment of convertible note
    ---       135,078  
                 
Change in operating assets and liabilities:
               
Accounts receivable
    (450,038 )     (243,915 )
Inventory
    (212,530 )     46,912  
Prepaid expenses and deferred charges
    77,145       36,063  
Notes receivable and accrued interest
    ---       777,710  
Accounts payable
    449,744       (343,456 )
Accrued liabilities
    53,800       (150,742 )
Accrued interest
    11,764       (859 )
Deferred revenue
    7,402       (29,237 )
Total
    441,760       676,319  
                 
Net Cash Used in Operating Activities
    (1,025,892 )     (901,687 )
                 
INVESTING ACTIVITIES :
               
Purchase of property and equipment
    (787 )     (16,233 )
Net Cash Used in Investing Activities
    (787 )     (16,233 )
                 
FINANCING ACTIVITIES :
               
Proceeds from sale of common stock and warrants, net
    ---       610,000  
Proceeds from exercise of common stock warrants
    ---       1,800,000  
Proceeds from issuance of convertible note and warrant, net
    485,008       ---  
Offering cost adjustment – preferred stock sale in 2011
    10,509       ---  
Repayment of principle due on convertible note
    ---       (776,609 )
Net Cash Provided by Financing Activities
    495,517       1,633,391  
                 
Net Increase (Decrease) in Cash
    (531,162 )     715,471  
                 
Cash,  beginning of period
    550,458       5,119  
Cash,  end of period
  $ 19,296     $ 720,590  
                 
SUPPLEMENTAL CASH FLOW DISCLOSURE:
               
Cash paid for interest
  $ 1,601     $ 14,516  
                 
Non-cash investing and financing activities:
               
Issuance of common stock for principle due on convertible note
  $ ---     $ 597,029  
                 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 
 



ULURU Inc.

NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)


NOTE 1.
COMPANY OVERVIEW AND BASIS OF PRESENTATION

Company Overview

ULURU Inc. (hereinafter “we”, “our”, “us”, “ULURU”, or the “Company”) is a Nevada corporation.  We are a diversified specialty pharmaceutical company committed to developing and commercializing a broad range of innovative wound care and muco-adhesive film products based on our patented Nanoflex® and OraDiscTM technologies, with the goal of improving outcomes for patients, health care professionals, and health care payers.

Basis of Presentation

In the opinion of management, the accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and include the accounts of ULURU Inc., a Nevada corporation, and its wholly-owned subsidiary, Uluru Delaware Inc., a Delaware corporation.  They do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation of the Company’s financial position as of June 30, 2015 and the results of its operations for the three and six months ended June 30, 2015 and 2014 and cash flows for the six months ended June 30, 2015 and 2014 have been made.

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, as well as disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods.  Actual results may differ from those estimates and assumptions.  These differences are usually minor and are included in our consolidated financial statements as soon as they are known.  Our estimates, judgments, and assumptions are continually evaluated based on available information and experience. Because of the use of estimates inherent in the financial reporting process, actual results could differ from those estimates.

All intercompany transactions and balances have been eliminated in consolidation.

Operating results for the three and six months ended June 30, 2015 are not necessarily indicative of the results that may be expected for the year ending December 31, 2015.

These condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014, as filed with the Securities and Exchange Commission on April 1, 2015, including the risk factors set forth therein.

Liquidity and Going Concern

The report of our independent registered public accounting firm for the fiscal year ended December 31, 2014, contained an explanatory paragraph to reflect its significant doubt about our ability to continue as a going concern as a result of our history of losses and our liquidity position, as discussed herein and in this Form 10-Q.  Based on our existing liquidity, the expected level of operating expenses, projected sales of our existing products combined with other revenues and financing transactions we are exploring, we believe that we do not have sufficient working capital to meet our working capital and capital expenditure requirements through the third quarter of 2015.  In the long run we cannot be sure that our anticipated revenue growth will be realized or that we will generate significant positive cash flow from operations.  Moreover, we may not be able to raise sufficient additional capital on acceptable returns, or at all, to continue operations and may not be able to execute any strategic transactions.  Therefore, we are unable to assert that our financial position is sufficient to fund operations beyond the third quarter of 2015, and as a result, there is substantial doubt about our ability to continue as a going concern beyond the third quarter of 2015.
 

 
NOTE 2.
SIGNIFICANT ACCOUNTING POLICIES

The significant accounting policies used in preparation of these condensed consolidated financial statements for the three and six months ended June 30, 2015 are consistent with those discussed in Note 2 to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2014, as filed with the Securities and Exchange Commission on April 1, 2015.
 
NOTE 3.
THE EFFECT OF RECENTLY ISSUED ACCOUNTING STANDARDS

In April 2015, the Financial Accounting Standards Board issued Update No. 2015-03, Simplifying the Presentation of Debt Issuance Costs, which requires debt issuance costs related to a recognized debt liability to be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. The guidance is effective January 1, 2016 with early adoption permitted.  The Company has elected early adoption as the guidance is a change in financial statement presentation only and will not have a material impact in the consolidated financial results.

There were no other new accounting pronouncements adopted or enacted during the periods presented that had, or are expected to have, a material impact on our financial statements.

 
NOTE 4.
SEGMENT INFORMATION

We operate in one business segment: the research, development and commercialization of pharmaceutical products.  Our corporate headquarters in the United States collects product sales, licensing fees, royalties, and sponsored research revenues from our arrangements with external customers and licensees.  Our entire business is managed by a single management team, which reports to the Chief Executive Officer.

Our revenues are currently derived primarily from seven licensees for international activities and our domestic sales activities of Altrazeal®.

Revenues per geographic area, along with relative percentages of total revenues, for the three and six months ended June 30 are summarized as follows:

   
Three Months Ended June 30,
   
Six Months Ended June 30,
 
Revenues
 
2015
   
%
   
2014
   
%
   
2015
   
%
   
2014
   
%
 
Domestic
  $ 7,085       3 %   $ 11,770       6 %   $ 13,887       3 %   $ 21,442       7 %
International
    251,912       97 %     197,524       94 %     539,758       97 %     289,833       93 %
Total
  $ 258,997       100 %   $ 209,294       100 %   $ 553,645       100 %   $ 311,275       100 %

A significant portion of our revenues are derived from a few major customers.  Customers with greater than 10% of total sales, along with their relative percentage of all sales, for the three and six months ended June 30 are represented on the following table:

     
Three Months Ended June 30,
   
Six Months Ended June 30,
 
Customers
Product
 
2015
   
2014
   
2015
   
2014
 
  Customer A
Altrazeal®
    91 %     87 %     92 %     59 %
  Customer B
Altrazeal®
    2 %     3 %     2 %     28 %
  Total
      93 %     90 %     94 %     87 %
 
 
NOTE 5.
INVENTORY

As of June 30, 2015, our inventory was composed of Altrazeal® finished goods, manufacturing costs incurred in the production of Altrazeal®, and raw materials.  Inventories are stated at the lower of cost (first in, first out method) or market.  We regularly review inventories on hand and write down the carrying value of our inventories for excess and potentially obsolete inventories based on historical usage and estimated future usage.  In assessing the ultimate realization of our inventories, we are required to make judgments as to future demand requirements.  As actual future demand or market conditions may vary from those projected by us, adjustment to inventories may be required.

The components of inventory, at the different stages of production, consisted of the following at June 30, 2015 and December 31, 2014:

Inventory
 
June 30, 2015
   
December 31, 2014
 
  Raw materials
  $ 48,393     $ 41,648  
  Work-in-progress
    468,573       271,571  
  Finished goods
    21,221       12,438  
  Total
  $ 538,187     $ 325,657  


NOTE 6.
PROPERTY, EQUIPMENT and LEASEHOLD IMPROVEMENTS

Property, equipment and leasehold improvements, net, consisted of the following at June 30, 2015 and December 31, 2014:

Property, equipment and leasehold improvements
 
June 30, 2015
   
December 31, 2014
 
  Laboratory equipment
  $ 424,888     $ 424,888  
  Manufacturing equipment
    1,599,894       1,599,894  
  Computers, office equipment, and furniture
    153,865       153,078  
  Computer software
    4,108       4,108  
  Leasehold improvements
    95,841       95,841  
      2,278,596       2,277,809  
  Less: accumulated depreciation and amortization
    (1,950,226 )     (1,845,699 )
  Property, equipment and leasehold improvements, net
  $ 328,370     $ 432,110  

Depreciation expense on property, equipment and leasehold improvements was $46,218 and $59,553 for the three months ended June 30, 2015 and 2014, respectively, and was $104,527 and $120,107 for the six months ended June 30, 2015 and 2014, respectively.

 
NOTE 7.
INTANGIBLE ASSETS

Intangible assets are composed of patents acquired in October, 2005.  Intangible assets, net consisted of the following at June 30, 2015 and December 31, 2014:

Intangible assets
 
June 30, 2015
   
December 31, 2014
 
  Patent - Amlexanox (Aphthasol®)
  $ 2,090,000     $ 2,090,000  
  Patent - Amlexanox (OraDisc™ A)
    6,873,080       6,873,080  
  Patent - OraDisc™
    73,000       73,000  
  Patent - Hydrogel nanoparticle aggregate
    589,858       589,858  
      9,625,938       9,625,938  
  Less: accumulated amortization
    ( 6,665,871 )     (6,430,249 )
  Intangible assets, net
  $ 2,960,067     $ 3,195,689  

Amortization expense for intangible assets was $118,461 and $118,461 for the three months ended June 30, 2015 and 2014, respectively, and was $235,622 and $235,622 for the six months ended June 30, 2015 and 2014, respectively.

The future aggregate amortization expense for intangible assets, remaining as of June 30, 2015, is as follows:
Calendar Years
 
Future Amortization
Expense
 
  2015 (Six months)
  $ 239,526  
  2016
    476,450  
  2017
    475,148  
  2018
    475,148  
  2019
    475,148  
  2020 & Beyond
    818,647  
  Total
  $ 2,960,067  


NOTE 8.
INVESTMENTS IN UNCONSOLIDATED ENTITIES

We use the equity method of accounting for investments in other companies that are not controlled by us and in which our interest is generally between 20% and 50% of the voting shares or we have significant influence over the entity, or both.

Altrazeal Trading Ltd.

On January 11, 2012, we executed a shareholders’ agreement for the establishment of Altrazeal Trading Ltd., a single purpose entity to be used for the exclusive marketing of Altrazeal® throughout the European Union, Australia, New Zealand, North Africa, and the Middle East.  As a result of this transaction, we received a non-dilutable 25% ownership interest in Altrazeal Trading Ltd.  On February 1, 2014, Altrazeal Trading Ltd. transferred all of their rights and obligations under the existing shareholders’ agreement to Altrazeal Trading GmbH.

Audited financial statements of Altrazeal Trading Ltd. for the years ended December 31, 2013 and 2014 and unaudited financial statements for the three and six months ended June 30, 2015 have not been released to us and, therefore, we have not included the effect of the financial activities of Altrazeal Trading Ltd. in our financial statements for each reporting period.  We believe that our share of the cumulative losses of Altrazeal Trading Ltd. for the six months ended June 30, 2015 and for the years ended December 31, 2014, 2013, and 2012 would exceed the carrying value of our investment, therefore the equity method of accounting would be suspended for such reporting periods and no additional losses would be charged to operations.

Based upon audited financial statements received in May 2014, our unrecorded share of Altrazeal Trading Ltd. losses for the year ended December 31, 2012 totaled $129,207.

Summarized financial information for our investment in Altrazeal Trading Ltd. assuming 100% ownership is as follows:

Altrazeal Trading Ltd.
 
December 31, 2012
 
  Balance sheet
     
Total assets
  $ 136,661  
Total liabilities
  $ 660,006  
Total stockholders’ (deficit)
  $ (523,345 )
  Statement of operations
       
Revenues
  $ 61,028  
Net (loss)
  $ (516,829 )

Altrazeal Trading GmbH

On February 1, 2014, Altrazeal Trading Ltd. transferred all of their rights and obligations under the existing shareholders’ agreement to Altrazeal Trading GmbH (“Altrazeal Trading”).  As a result of this transfer, we received a non-dilutable 25% ownership interest in Altrazeal Trading.

Audited financial statements of Altrazeal Trading for the years ended December 31, 2013 and 2014 and unaudited financial statements for the three and six months ended June 30, 2015 have not been released to us and, therefore, we have not included the effect of the financial activities of Altrazeal Trading in our financial statements for each reporting period.  We believe that our share of the cumulative losses of Altrazeal Trading for the six months ended June 30, 2015 and for the years ended December 31, 2014 and 2013 would exceed the carrying value of our investment, therefore the equity method of accounting would be suspended for such reporting periods and no additional losses would be charged to operations.

Based upon the unaudited financial statements for the year ended December 31, 2014, our unrecorded share of Altrazeal Trading cumulative losses as of December 31, 2014 totaled $295,477.

Summarized financial information for our investment in Altrazeal Trading assuming 100% ownership is as follows:

Altrazeal Trading GmbH
 
December 31, 2014
(Unaudited)
   
December 31, 2013
(Unaudited)
 
  Balance sheet
           
Total assets
  $ 1,039,343     $ 757,784  
Total liabilities
  $ 2,178,865     $ 1,563,046  
Total stockholders’ (deficit)
  $ (1,139,522 )   $ (805,262 )
  Statement of operations
               
Revenues
  $ 882,583     $ ---  
Net (loss)
  $ (465,580 )   $ (798,009 )

 
 
Purchase of Altrazeal Trading GmbH – May 2015

On May 12, 2015, we entered into a Binding Term Sheet (the “Term Sheet”) with IPMD GmbH, an Austrian limited liability company, and Firnron Ltd., a Cypriot limited liability company (collectively, the “Seller”) related to our purchase of 75% of the share capital of Altrazeal Trading.  We currently own the remaining 25% of share capital of Altrazeal Trading.  Altrazeal Trading is the distributor of Altrazeal® transforming powder dressing in European Union, Australia, New Zealand, Middle East (excluding Jordan and Syria), North Africa, Albania, Bosnia, Croatia, Kosovo, Macedonia, Montenegro, and Serbia.

Pursuant to the terms and conditions in the Term Sheet, the purchase price will be composed of 3,150,000 Euro for the purchase of the share capital of Altrazeal Trading and 88,834 Euro for the purchase of product inventory.  The purchase of the share capital of Altrazeal Trading will be paid in installments, with 1,147,200 Euro due at closing (of which 646,500 Euro will be paid with an offset of accounts receivable) and five installment payments of 500,700 Euro due by no later than June 30, 2015, August 31, 2015, October 31, 2015, and December 31, 2015.  The sale is structured as an “installment sale”, with 15% of equity in Altrazeal Trading being transferred upon the payment of each installment by us.  The installments are payable in either cash or in shares of our common stock at our option.  If installment payments are made in common stock, the calculation of shares to be issued will be 110% of the average closing price for the last 10 trading days prior to the installment payment date and include a warrant for 10% of the shares issued with a premium of $0.30 per share to the market price. The purchase of the product inventory for 88,834 Euro will be paid on September 30, 2015.
 
To the extent we issue shares of common stock to pay the purchase price, we have agreed to register the resale of such shares to the extent possible. The Term Sheet anticipates the negotiation and execution of a purchase agreement containing all terms of the Term Sheet and other standard terms for such a transaction within 60 days.  Such 60 day period expired on July 21, 2015 but both parties are continuing in their efforts to finalize the negotiation and execution of a purchase agreement by no later than November 15, 2015.
 
ORADISC GmbH

On October 19, 2012, we executed a shareholders’ agreement for the establishment of ORADISC GmbH, a single purpose entity to be used for the exclusive development and marketing of OraDisc™ erodible film technology products.  We received a non-dilutable 25% ownership interest in ORADISC GmbH.

Audited financial statements of ORADISC GmbH for the years ended December 31, 2013 and 2014 and unaudited financial statements for the three and six months ended June 30, 2015 have not been released to us and, therefore, we have not included the effect of the financial activities of ORADISC GmbH. in our financial statements for each reporting period.  We believe that our share of the cumulative losses of ORADISC GmbH for the six months ended June 30, 2015 and for the years ended December 31, 2014 and 2013 would exceed the carrying value of our investment, therefore the equity method of accounting would be suspended for such reporting periods and no additional losses would be charged to operations.

Based upon the unaudited financial statements for the year ended December 31, 2013, our unrecorded share of ORADISC GmbH cumulative losses as of December 31, 2013 totaled $11,430.

Summarized financial information for our investment in ORADISC GmbH assuming 100% ownership is as follows:

ORADISC GmbH
 
December 31, 2013
(Unaudited)
 
  Balance sheet
     
Total assets
  $ 305,069  
Total liabilities
  $ 302,572  
Total stockholders’ equity
  $ 2,497  
  Statement of operations
       
Revenues
  $ ---  
Net (loss)
  $ (34,671 )
 
Altrazeal AG

On February 1, 2014, we executed a shareholders’ agreement with Altrazeal AG, a single purpose entity for the marketing of Altrazeal® in several territories, including Africa (markets not already licensed), Latin America, Georgia, Turkmenistan, Ukraine, the Commonwealth of Independent States, Jordan, Syria, Asia and the Pacific (excluding China, Hong Kong, Macau, Taiwan, South Korea, Japan, Australia, and New Zealand).  As a result of this transaction, we received a non-dilutable 25% ownership interest in Altrazeal AG.

Audited or unaudited financial statements of Altrazeal AG for the three and six months ended June 30, 2015 and for the year ended December 31, 2014 have not been released to us and, therefore, we have not included the effect of the financial activities of Altrazeal AG in our financial statements for such reporting period.  We believe that our share of the cumulative losses of Altrazeal AG for the six months ended June 30, 2015 and for the year ended December 31, 2014 would exceed the carrying value of our investment, therefore the equity method of accounting would be suspended for such reporting periods and no additional losses would be charged to operations.

 
- 10 -


NOTE  9.
ACCRUED LIABILITIES

Accrued liabilities consisted of the following at June 30, 2015 and December 31, 2014:

Accrued Liabilities
 
June 30, 2015
   
December 31, 2014
 
  Accrued taxes – payroll
  $ 106,299     $ 106,299  
  Accrued compensation/benefits
    208,678       96,795  
  Accrued insurance payable
    6,616       69,815  
  Accrued property taxes
    5,400       ---  
  Product rebates/returns
    8       13  
  Other
    ---       279  
  Total accrued liabilities
  $ 327,001     $ 273,201  


NOTE 10.
PROMISSORY NOTE PAYABLE

Debt Financing – April 2015

On April 15, 2015, we entered into a Securities Purchase Agreement dated April 14, 2015 (the “Purchase Agreement”) with Inter-Mountain Capital Corp. (“Inter-Mountain”) related to our issuance of a $550,000 Promissory Note (the “April 2015 Note”).  The purchase price for the April 2015 Note, which reflects a $50,000 original issue discount, was $500,000. The Purchase Agreement also included representations and warranties, restrictive covenants and indemnification provisions standard for similar transactions.

The April 2015 Note bears interest at the rate of 10.0% per annum, with monthly installment payments of $45,000 commencing on the date that is 120 calendar days after the issuance date of the Note. At our option, subject to certain volume, price and other conditions, the monthly installments may be paid in whole, or in part, in cash or in Common Stock.  If the monthly installments are paid in Common Stock, such shares being issued will be based on a price that is 80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days.  The percentage declines to 70% if the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days is less than $0.05 per share.  The April 2015 Note is not subject to conversion at the discretion of Inter-Mountain.

At our option, the outstanding principal balance of the April 2015 Note, or a portion thereof, may be prepaid in cash at 120% of the amount elected to be prepaid.  The April 2015 Note is unsecured.

Events of default under the April 2015 Note include failure to make required payments, the entry of a $100,000 judgment not stayed within 30 days, breach of representations or covenants under the transaction documents, various events associated with insolvency or failure to pay debts, delisting of the Common Stock, a restatement of financial statements and a default under certain other agreements.  In the event of default, the interest rate under the April 2015 Note increases to 18% and the April 2015 Note becomes callable at a premium.  In addition, Inter-Mountain has all remedies under law and equity.

As part of the debt financing, Inter-Mountain also received a warrant (the “Warrant”) to purchase up to an aggregate of 194,118 shares of Common Stock.  The Warrant has an exercise price of $0.85 per share and expires on April 30, 2020. The Warrant includes a standard net cashless exercise provision and provisions requiring proportionate adjustments in connection with a recapitalization transaction.

As part of the debt financing, we entered into a Registration Rights Agreement whereby we agreed to prepare and file with the Securities and Exchange Commission (the “SEC”) a registration statement no later than May 11, 2015 and to cause such registration statement to be declared effective no later than 120 after the closing date and to keep such registration statement effective for a period of no less than 180 days.  In accordance with our obligations under the Registration Rights Agreement, we filed with the SEC a registration statement that was declared effective on June 4, 2015.
 
 
- 11 -

 
Using specific guidelines in accordance with U.S. GAAP, we allocated the value of the proceeds received to the promissory note and to the warrant on a relative fair value basis.  We calculated the fair value of the warrant issued with the debt instrument using the Black-Scholes valuation method, using the same assumptions used for valuing employee stock options, except the contractual life of the warrant was used. Using the effective interest method, the allocated fair value of the warrant was recorded as a debt discount and is being amortized over the expected term of the promissory note to interest expense.

Information relating to our promissory note payable is as follows:

                   
As of June 30, 2015
       
Transaction
 
Initial Principal Amount
   
Interest
Rate
 
Maturity
Date
Conversion Price (1)
 
Principal
Balance
   
Unamortized Debt
Discount
   
Unamortized Debt Issuance Costs
   
Carrying
Value
 
  April 2015 Note
  $ 550,000       10.0 %
08/12/2016
    $ 550,000     $ 58,100     $ 41,897     $ 450,003  
  Total
  $ 550,000                 $ 550,000     $ 58,100     $ 41,897     $ 450,003  

  (1)
As part of the April 2015 Note, at our option, subject to certain volume, price and other conditions, the monthly installments of principle and interest due under the April 2015 Note may be paid in whole, or in part, in cash or in Common Stock.  If the monthly installments are paid in Common Stock, such shares being issued will be based on a price that is 80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days.  The percentage declines to 70% if the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days is less than $0.05 per share.
 
The amount of interest cost recognized from our promissory note and convertible notes payable was $11,764 and $5,952 for the three months ended June 30, 2015 and 2014, respectively, and was $11,764 and $19,897 for the six months ended June 30, 2015 and 2014, respectively.

The amount of debt discount amortized from our promissory note and convertible notes payable was $11,035 and $2,655 for the three months ended June 30, 2015 and 2014, respectively, and was $11,035 and $(78,630) for the six months ended June 30, 2015 and 2014, respectively.

The future minimum payments relating to our promissory note payable, as of June 30, 2015, are as follows:

   
Payments Due By Period
 
Transaction
 
Total
   
2014 (Six Months)
   
2015
   
2016
   
2017
   
2018
 
  April 2015 Note
  $ 550,000     $ 225,000     $ 325,000     $ ---     $ ---     $ ---  
  Total
  $ 550,000     $ 225,000     $ 325,000     $ ---     $ ---     $ ---  

 
- 12 -

 
NOTE 11.
STOCKHOLDERS’ EQUITY

Common Stock

As of June 30, 2015, we had 24,819,534 shares of Common Stock issued and outstanding.  For the three months ended June 30, 2015, we issued 361,516 shares of Common Stock issued for the cashless exercise of a warrant held by Inter-Mountain Capital Corp.

Preferred Stock

As of June 30, 2015, we had no shares of Series A Preferred Stock (the “Series A Shares”) issued and outstanding.  For the three months ended June 30, 2015, we did not issue or redeem any Series A Shares.

Warrants

The following table summarizes the warrants outstanding and the number of shares of Common Stock subject to exercise as of June 30, 2015 and the changes therein during the six months then ended:

   
Number of Shares of Common Stock Subject to Exercise
   
Weighted – Average
Exercise Price
 
Balance as of December 31, 2014
    1,676,401     $ 1.14  
Warrants issued
    194,118     $ 0.85  
Warrants exercised
    (392,857 )   $ 0.35  
Warrants cancelled
    (357,155 )   $ 2.85  
Balance as of June 30, 2015
    1,120,507     $ 0.82  

For the three months ended June 30, 2015, we issued a warrant to Inter-Mountain to purchase up to an aggregate of 194,118 shares of Common Stock.  The Warrant has an exercise price of $0.85 per share and expires on April 30, 2020.

Of the warrant shares subject to exercise as of June 30, 2015, expiration of the right to exercise is as follows:
Date of Expiration
 
Number of Warrant Shares of Common Stock Subject to Expiration
 
  June 13, 2016
    35,000  
  July 16, 2016
    116,667  
  July 28, 2016
    34,722  
  March 14, 2018
    660,000  
  January 15, 2019
    80,000  
  April 30, 2020
    194,118  
  Total
    1,120,507  


 
- 13 -




NOTE 12.
EARNINGS PER SHARE

Basic and Diluted Net Loss Per Share

In accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 260, Earnings per Share, basic earnings (loss) per common share is computed by dividing net income (loss) by the weighted average number of common shares outstanding for the period.  Diluted earnings (loss) per common share is computed by dividing net income (loss) by the weighted average number of common shares outstanding during the period, increased to include potential dilutive common shares.  The effect of outstanding stock options, restricted vesting Common Stock, convertible debt, convertible preferred stock, and warrants, when dilutive, is reflected in diluted earnings (loss) per common share by application of the treasury stock method.  We have excluded all outstanding stock options, restricted vesting Common Stock, convertible debt, convertible preferred stock, and warrants from the calculation of diluted net loss per common share because all such securities are antidilutive for all periods presented.

Shares used in calculating basic and diluted net loss per common share exclude these potential common shares as of June 30, 2015 and December 31, 2014:


   
June 30, 2015
   
December 31, 2014
 
Warrants to purchase Common Stock
    1,120,507       1,676,401  
Stock options to purchase common stock
    1,664,573       1,699,907  
Common stock issuable upon the assumed conversion of payments due under our promissory note from April 2015 (1)
    1,189,050       ---  
  Total
    3,974,130       3,376,308  

(1)
As part of the April 2015 Note, at our option, subject to certain volume, price and other conditions, the monthly installments of principle and interest due under the April 2015 Note may be paid in whole, or in part, in cash or in Common Stock.  If the monthly installments are paid in Common Stock, such shares being issued will be based on a price that is 80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days.  The percentage declines to 70% if the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days is less than $0.05 per share.  For the purposes of this Table, we have assumed that all outstanding monthly installments of principal and interest will be paid in Common Stock based on a price of $0.50 per share (80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days prior to June 30, 2015).

 
- 14 -

 
NOTE 13.
SHARE BASED COMPENSATION

The Company’s share-based compensation plan, the 2006 Equity Incentive Plan, as amended (“Equity Incentive Plan”), is administered by the compensation committee of the Board of Directors (“Board”), which selects persons to receive awards and determines the number of shares subject to each award and the terms, conditions, performance measures and other provisions of the award.

Our Board granted the following incentive stock option awards to executives or employees and nonstatutory stock option awards to directors or non-employees for the three and six months ended June 30:

   
Three Months Ended
June 30,
   
Six Months Ended
 June 30,
 
   
2015
   
2014
   
2015
   
2014
 
Incentive Stock Options  (1)
                       
Quantity
    ---       ---       ---       ---  
Weighted average fair value per share
    ---       ---       ---       ---  
Fair value
    ---       ---       ---       ---  
                                 
Nonstatutory Stock Options  (2)
                               
Quantity
    ---       ---       ---       ---  
Weighted average fair value per share
    ---       ---       ---       ---  
Fair value
    ---       ---       ---       ---  

 
(1)
The Company did not award any incentive stock options for the three and six months ended June 30, 2015 and 2014, respectively.
 
(2)
The Company did not award any nonstatutory stock options for the three and six months ended June 30, 2015 and 2014, respectively.

We account for share-based compensation under FASB ASC Topic 718, Stock Compensation, which requires the measurement and recognition of compensation expense for all share-based payment awards made to employees, consultants, and directors based on estimated fair values of the award on the grant date.  We use the Black-Scholes option-pricing model to estimate the fair value of share-based awards.
 
Stock Options (Incentive and Nonstatutory)

The following table summarizes share-based compensation related to stock options for the three and six months ended June 30:

   
Three Months Ended
 June 30,
   
Six Months Ended
 June 30,
 
   
2015
   
2014
   
2015
   
2014
 
Research and development
  $ 18,819     $ 5,365     $ 37,431     $ 10,672  
Selling, general and administrative
    51,019       17,018       107,755       36,251  
  Total share-based compensation expense
  $ 69,838     $ 22,383     $ 145,186     $ 46,923  

At June 30, 2015, the balance of unearned share-based compensation to be expensed in future periods related to unvested stock option awards, as adjusted for expected forfeitures, is approximately $408,000.  The period over which the unearned share-based compensation is expected to be recognized is approximately twenty seven months.

The following table summarizes the stock options outstanding and the number of shares of Common Stock subject to exercise as of June 30, 2015 and the changes therein during the six months then ended:

   
Stock Options
   
Weighted Average Exercise Price per Share
 
Outstanding as of December 31, 2014
    1,699,907     $ 1.73  
Granted
    ---       ---  
Forfeited/cancelled
    (35,334 )   $ 1.77  
Exercised
    ---       ---  
Outstanding as of June 30, 2015
    1,664,573     $ 1.73  
 
 
 
- 15 -

The following table presents the stock option grants outstanding and exercisable as of June 30, 2015:

Options Outstanding
   
Options Exercisable
 
Stock Options Outstanding
   
Weighted Average Exercise Price per Share
   
Weighted Average Remaining Contractual Life in Years
   
Stock Options Exercisable
   
Weighted Average Exercise Price per Share
 
  882,500     $ 0.33       7.7       640,000     $ 0.33  
  680,000       1.15       7.4       77,500       1.15  
  33,334       2.55       4.8       33,334       2.55  
  68,739       25.07       2.1       68,739       25.07  
  1,664,573     $ 1.73       7.3       819,573     $ 2.57  

Restricted Stock Awards

Restricted stock awards, which typically vest over a period of two to five years, are issued to certain key employees and are subject to forfeiture until the end of an established restriction period.  We utilize the market price on the date of grant as the fair market value of restricted stock awards and expense the fair value on a straight-line basis over the vesting period.

For the three and six months ended June 30, 2015 and 2014, we did not grant any restricted stock awards.

At June 30, 2015, the balance of unearned share-based compensation to be expensed in future periods related to restricted stock awards, as adjusted for expected forfeitures, is zero.
 
Summary of Plans

2006 Equity Incentive Plan

In March 2006, our Board adopted and our stockholders approved our Equity Incentive Plan, which initially provided for the issuance of up to 133,333 shares of our Common Stock pursuant to stock option and other equity awards.  At the annual meetings of the stockholders held on May 8, 2007, December 17, 2009, June 15, 2010, June 14, 2012, June 13, 2013, and on June 5, 2014, our stockholders approved amendments to the Equity Incentive Plan to increase the total number of shares of Common Stock issuable under the Equity Incentive Plan pursuant to stock options and other equity awards by 266,667 shares, 200,000 shares, 200,000 shares, 400,000 shares, 600,000 shares, and 1,000,000 shares, respectively, to a total of 2,800,000 shares.

In December 2006, we began issuing stock options to employees, consultants, and directors.  The stock options issued generally vest over a period of one to four years and have a maximum contractual term of ten years.  In January 2007, we began issuing restricted stock awards to our employees.  Restricted stock awards generally vest over a period of six months to five years after the date of grant.  Prior to vesting, restricted stock awards do not have dividend equivalent rights, do not have voting rights and the shares underlying the restricted stock awards are not considered issued and outstanding.  Shares of Common Stock are issued on the date the restricted stock awards vest.

As of June 30, 2015, we had granted options to purchase 2,061,167 shares of Common Stock since the inception of the Equity Incentive Plan, of which 1,664,573 were outstanding at a weighted average exercise price of $1.73 per share, and we had granted awards for 68,616 shares of restricted stock since the inception of the Equity Incentive Plan, of which none were outstanding.  As of June 30, 2015, there were 1,065,981 shares that remained available for future grants under our Equity Incentive Plan.

 
- 16 -


NOTE 14.
FAIR VALUE MEASUREMENTS

In accordance with FASB ASC Topic 820, Fair Value Measurements, (“ASC Topic 820”) certain assets and liabilities of the Company are required to be recorded at fair value.  Fair value is determined based on the exchange price that would be received for an asset or paid to transfer a liability in an orderly transaction between market participants.  The guidance in ASC Topic 820 also establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimized the use of unobservable inputs by requiring that the most observable inputs be used when available.

Observable inputs are based on market data obtained from independent sources, while unobservable inputs are based on our market assumptions.  Unobservable inputs require significant management judgment or estimation.  In some cases, the inputs used to measure an asset or liability may fall into different levels of the fair value hierarchy.  In those instances, the fair value measurement is required to be classified using the lowest level of input that is significant to the fair value measurement.  Such determination requires significant management judgment.
 
The three-tier value hierarchy, which prioritizes the inputs used in the valuation methodologies, is as follows:

 
Level 1
Valuations based on quoted prices (unadjusted) for identical assets or liabilities in active markets.

 
Level 2
Valuations based on observable inputs other than quoted prices in Level 1, such as quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, and other inputs that are observable or can be corroborated by observable market data.

 
Level 3
Valuations based on unobservable inputs reflecting the Company’s own assumptions, consistent with reasonably available assumptions made by other market participants.

Assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurements.  We review the fair value hierarchy classification on a quarterly basis.  Changes in the observability of valuation inputs may result in a reclassification of levels for certain securities within the fair value hierarchy.

Our financial instruments, including cash, cash equivalents, accounts receivable, and accounts payable are carried at cost, which approximates their fair value because of the short-term maturity of these instruments.  We believe that the carrying value of our other receivable and convertible note payable balances approximates fair value based on a valuation methodology using the income approach and a discounted cash flow model.

The following table summarizes the fair value of our financial instruments at June 30, 2015 and December 31, 2014.

Description
 
June 30, 2015
   
December 31, 2014
 
  Liabilities:
           
Promissory note – April 2015
  $ 550,000       ---  
                 
                 


NOTE 15.
INCOME TAXES

There was no current federal tax provision or benefit recorded for any period since inception, nor were there any recorded deferred income tax assets, as such amounts were completely offset by valuation allowances.


 
- 17 -


 
NOTE 16.
COMMITMENTS AND CONTINGENCIES

Operating Leases

On January 31, 2006 we entered into a lease agreement for office and laboratory space in Addison, Texas.  The lease commenced on April 1, 2006 and originally continued until April 1, 2013.  The lease required a minimum monthly lease obligation of $9,330, which was inclusive of monthly operating expenses, until April 1, 2011 and at such time increased to $9,776, which was inclusive of monthly operating expenses.  On February 22, 2013, we executed an Amendment to Lease Agreement (the “Lease Amendment”) that renewed and extended our lease until March 31, 2015.  The Lease Amendment required a minimum monthly lease obligation of $9,193, which was inclusive of monthly operating expenses, until March 31, 2014 and at such time, increased to $9,379, which was inclusive of monthly operating expenses.  On March 17, 2015, we executed a Second Amendment to Lease Agreement (the “Second Amendment”) that renewed and extended our lease until March 31, 2018.  The Second Amendment requires a minimum monthly lease obligation of $9,436, which is inclusive of monthly operating expenses.

On December 10, 2010 we entered into a lease agreement for certain office equipment that commenced on February 1, 2011 and continued until February 1, 2015 and required a minimum lease obligation of $744 per month.  On January 16, 2015 we entered into a new lease agreement for certain office equipment.  The new office equipment lease, that commenced on February 1, 2015 and continues until February 1, 2018, requires a minimum lease obligation of $551 per month.

The future minimum lease payments under the 2015 office lease and the 2015 equipment lease are as follows as of June 30, 2015:

Calendar Years
 
Future Lease Expense
 
  2015 (Six months)
  $ 59,920  
  2016
    119,840  
  2017
    119,840  
  2018
    28,858  
  2019
    ---  
  Total
  $ 328,458  

Rent expense for our operating leases amounted to $29,837 and $30,446 for the three months ended June 30, 2015 and 2014, respectively, and $61,002 and $60,826 for the six months ended June 30, 2015 and 2014, respectively.

Indemnification

In the normal course of business, we enter into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications. Our exposure under these agreements is unknown because it involves claims that may be made against us in the future, but have not yet been made. To date, we have not paid any claims or been required to defend any action related to our indemnification obligations. However, we may record charges in the future as a result of these indemnification obligations.
 
In accordance with our restated articles of incorporation and our amended and restated bylaws, we have indemnification obligations to our officers and directors for certain events or occurrences, subject to certain limits, while they are serving at our request in their respective capacities. There have been no claims to date and we have a director and officer insurance policy that enables us to recover a portion of any amounts paid for future potential claims. We have also entered into contractual indemnification agreements with each of our officers and directors.
 
 
 
- 18 -



Related Party Transactions and Concentration

On January 17, 2013, the Board of Directors of the Company appointed Helmut Kerschbaumer and Klaus Kuehne to each serve as a director of the Company.

Mr. Kerschbaumer currently serves as a director of Altrazeal Trading GmbH, Altrazeal AG, and Melmed Holding AG (collectively, the “Altrazeal Distributors”) and Mr. Kuehne currently serves as a director of Altrazeal AG.  In such capacities, Mr. Kerschbaumer may be considered, either singularly or collectively, to have control of, and make investment and business decisions on behalf of the Altrazeal Distributors and Mr. Kuehne may be considered, either singularly or collectively, to have control of, and make investment and business decisions on behalf of Altrazeal AG.

Each of Mr. Kerschbaumer and Mr. Kuehne are shareholders of ORADISC GmbH and may be considered, either singularly or collectively, to have control of, and make investment and business decisions on behalf of the ORADISC GmbH.

Currently, we are party to License and Supply Agreements with Altrazeal Trading GmbH, Altrazeal AG, and Melmed Holding AG for the marketing and distribution of Altrazeal in various international territories.  We are also party to a License and Supply Agreement with ORADISC GmbH for the marketing of all applications of our OraDisc™ erodible film technology for dental applications including benzocaine (OraDisc™ B), re-mineralization dental strips, fluoride dental strips, long-acting breath freshener, amlexanox (OraDisc™ A) in certain territories, anti-psychotics, neurologic products, and actives for the treatment of erectile dysfunction.

For the six months ended June 30, 2015 and 2014, the Company recorded revenues, in approximate numbers, of $527,000 and $278,000, respectively, with the various Altrazeal Distributors, which represented 95% and 89% of our total revenues.  As of June 30, 2015 and December 31, 2014, Altrazeal Distributors had an outstanding net accounts receivable, in approximate numbers, of $1,250,000 and $798,000, respectively, which represented 99.8% and 99.5% of our total outstanding accounts receivables.

Purchase of Altrazeal Trading GmbH – May 2015

On May 12, 2015, we entered into a Binding Term Sheet (the “Term Sheet”) with IPMD GmbH, an Austrian limited liability company, and Firnron Ltd., a Cypriot limited liability company (collectively, the “Seller”) related to our purchase of 75% of the share capital of Altrazeal Trading.  We currently own the remaining 25% of share capital of Altrazeal Trading.  Altrazeal Trading is the distributor of Altrazeal® transforming powder dressing in European Union, Australia, New Zealand, Middle East (excluding Jordan and Syria), North Africa, Albania, Bosnia, Croatia, Kosovo, Macedonia, Montenegro, and Serbia.
 
Pursuant to the terms and conditions in the Term Sheet, the purchase price will be composed of 3,150,000 Euro for the purchase of the share capital of Altrazeal Trading and 88,834 Euro for the purchase of product inventory.  The purchase of the share capital of Altrazeal Trading will be paid in installments, with 1,147,200 Euro due at closing (of which 646,500 Euro will be paid with an offset of accounts receivable) and five installment payments of 500,700 Euro due by no later than June 30, 2015, August 31, 2015, October 31, 2015, and December 31, 2015.  The sale is structured as an “installment sale”, with 15% of equity in Altrazeal Trading being transferred upon the payment of each installment by us.  The installments are payable in either cash or in shares of our common stock at our option.  If installment payments are made in common stock, the calculation of shares to be issued will be 110% of the average closing price for the last 10 trading days prior to the installment payment date and include a warrant for 10% of the shares issued with a premium of $0.30 per share to the market price. The purchase of the product inventory for 88,834 Euro will be paid on September 30, 2015.

To the extent we issue shares of common stock to pay the purchase price, we have agreed to register the resale of such shares to the extent possible. The Term Sheet anticipates the negotiation and execution of a purchase agreement containing all terms of the Term Sheet and other standard terms for such a transaction within 60 days.  Such 60 day period expired on July 21, 2015 but both parties are continuing in their efforts to finalize the negotiation and execution of a purchase agreement by no later than November 15, 2015.

 
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Related Party Obligations

Since 2011, our named executive officers and certain key executives have temporarily deferred portions of their compensation as part of a plan to conserve the Company’s cash and financial resources.

As of June 30, 2015, the following table summarizes the compensation temporarily deferred and subsequent repayments:

Name
 
2015
   
2014
   
2013
   
2012
   
2011
   
Total
 
  Kerry P. Gray (1) (2) (3)
  $ 151,806     $ (119,986 )   $ (91,000 )   $ 220,673     $ 140,313     $ 301,806  
  Terrance K. Wallberg
    14,966       (25,000 )     (35,769 )     24,230       36,539       14,996  
  Total
  $ 166,772     $ (144,986 )   $ (126,769 )   $ 244,903     $ 176,852     $ 316,772  

 
(1)
During 2015, Mr. Gray temporarily deferred compensation of $151,806 which consisted of $46,806 earned as salary compensation for his duties as President of the Company and $105,000 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors.
 
(2)
During 2014, Mr. Gray temporarily deferred compensation of $150,000 which consisted of $62,500 earned as salary compensation for his duties as President of the Company and $87,500 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors.  During 2014, Mr. Gray was also repaid $269,986 of temporarily deferred compensation, of which $100,000 was used by Mr. Gray for funding required pursuant to the March 2013 Offering.
 
(3)
During 2013, Mr. Gray temporarily deferred compensation of $221,500 which consisted of $11,500 earned pursuant to a Separation Agreement and $210,000 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors.  During 2013, Mr. Gray was also repaid $312,500 of temporarily deferred compensation, of which $300,000 was used by Mr. Gray for funding required pursuant to the March 2013 Offering.

As of June 30, 2015, the Company’s obligation for temporarily deferred compensation was $316,772 of which $124,272 was included in accrued liabilities and $192,500 was included in accounts payable, respectively.

As of December 31, 2014, the Company’s obligation for temporarily deferred compensation was $150,000 of which $62,500 was included in accrued liabilities and $87,500 was included in accounts payable, respectively.

Contingent Milestone Obligations

We are subject to paying Access Pharmaceuticals, Inc. (“Access”) for certain milestones based on our achievement of certain annual net sales, cumulative net sales, and/or our having reached certain defined technology milestones including licensing agreements and advancing products to clinical development.  As of June 30, 2015, the future milestone obligations that we are subject to paying Access, if the milestones related thereto are achieved, total $4,750,000.  Such milestones are based on total annual sales of 20 and 40 million dollars of certain products, annual sales of 20 million dollars of any one certain product, and cumulative sales of such products of 50 and 100 million dollars.

On March 7, 2008, we terminated the license agreement with ProStrakan Ltd. for Amlexanox-related products in the United Kingdom and Ireland.  As part of the termination, we agreed to pay ProStrakan Ltd. a royalty of 30% on any future payments received by us from a new licensee in the United Kingdom and Ireland territories, up to a maximum of $1,400,000.  On November 17, 2008, we entered into a licensing agreement for Amlexanox-related product rights to the United Kingdom and Ireland territories with MEDA AB.

 
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NOTE 17.
LEGAL PROCEEDINGS

On or about August 22, 2014, Inter-Mountain Capital Corp. (“Inter-Mountain”) filed a Complaint against ULURU in the U.S. Federal Court for the District of Utah, Central Division.  The Complaint relates to Inter-Mountain’s delivery of a notice of a cashless exercise with respect to its last remaining warrant to purchase Common Stock on or about May 1, 2014 purporting to exercise it with respect to the delivery of 782,284 shares of Common Stock under the non-standard cashless exercise or conversion provisions in the warrant.  The Company declined to honor the exercise on the basis that, as a result of an amendment to the warrant agreed to in December 2013, the warrant was exercisable, on a cashless basis, with respect to only 261,516 shares of Common Stock as of May 1, 2014.  Inter-Mountain alleged that the Company’s refusal to honor the exercise constituted a breach of the warrant, breach of implied covenant of good faith and fair dealing, unjust enrichment, a violation of securities laws and common law fraud and sought actual damages, consequential damages, treble damages, specific performance, attorneys’ fees and costs and other relief.  Answers and counterclaims were filed.

On April 15, 2015, the Company and Inter-Mountain entered into a Settlement Agreement (the “Settlement Agreement”) for the purpose of settling the pending litigation between the Company and Inter-Mountain.  Under the Settlement Agreement and related documents, the Company and Inter-Mountain agreed that Inter-Mountain would exercise the warrant and receive 361,516 shares of Common Stock.  The Settlement Agreement also included standard releases and anticipated the prompt filing of dismissal documents.  As part of the settlement, the Company and Inter-Mountain signed and closed under the Securities Purchase Agreement described in Note 10.
 
From time to time, we may be involved in litigation relating to claims arising out of our operations in the normal course of business. We are not currently a party to any legal proceedings, the adverse outcome of which, in management’s opinion, individually or in the aggregate, would have a material adverse effect on the results of our operations or financial position. There are no material proceedings to which any director, officer or any of our affiliates, any owner of record or beneficially of more than five percent of any class of our voting securities, or any associate of any such director, officer, our affiliates, or security holder, is a party adverse to us or our consolidated subsidiary or has a material interest adverse thereto.

NOTE 18.
SUBSEQUENT EVENTS

None.
 

 


 
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ITEM 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis together with all financial and non-financial information appearing elsewhere in this report and with our consolidated financial statements and related notes included in our 2014 Annual Report on Form 10-K, referred to as our 2014 Form 10-K, which has been previously filed with the Securities and Exchange Commission on April 1, 2015, including the risk factors set forth therein.  In addition to historical information, the following discussion and other parts of this report contain forward-looking information that involve risks and uncertainties.  Our actual results could differ materially from those anticipated by such forward-looking information due to competitive factors and other risks discussed in our 2014 Form 10-K under “Risks Associated with our Business”.

Business Overview

ULURU Inc. (together with our subsidiaries, “we”, “our”, “us”, “ULURU”, or the “Company”) is a Nevada corporation.  We are a diversified specialty pharmaceutical company committed to developing and commercializing a broad range of innovative wound care and mucoadhesive film products based on our patented Nanoflex® and OraDiscTM technologies, with the goal of improving outcomes for patients, health care professionals and health care payers.

Our strategy is twofold:

§
Establish a market leadership position in wound management by developing and commercializing a customer focused portfolio of innovative wound care products based on our Nanoflex® technology to treat the various phases of wound healing; and
§
Develop our oral mucoadhesive film technology (OraDiscTM) and for systemic drug delivery and delivery of actives to the oral cavity.

Utilizing our technologies, three of our products have been approved for marketing in various global markets.  In addition, numerous additional products are under development utilizing our patented Nanoflex® and OraDiscTM technologies.

Altrazeal® Transforming Powder Dressing, based on our Nanoflex® technology, has the potential to change the way health care providers approach their treatment of wounds.  Launched domestically in September 2008 and internationally in July 2012, the product is indicated for exuding wounds such as partial thickness burns, donor sites, abrasions, surgical, acute and chronic wounds.

Aphthasol®, our Amlexanox 5% paste product, is the first drug approved by the FDA for the treatment of canker sores.

OraDisc™ A was initially developed as a drug delivery system to treat canker sores with the same active ingredient (amlexanox) that is used in Aphthasol® paste. We anticipate that higher amlexanox concentrations will be achieved at the disease site, increasing the effectiveness of the product.  OraDisc™ A was approved by the FDA in September 2004.
 
Recent Developments

Debt Financing – April 2015

On April 15, 2015, we entered into a Securities Purchase Agreement dated April 14, 2015 (the “Purchase Agreement”) with Inter-Mountain Capital Corp., a Delaware corporation (“Inter-Mountain”) related to our issuance of a $550,000 Promissory Note (the “April 2015 Note”).  The purchase price for the April 2015 Note, which reflects a $50,000 original issue discount, was $500,000.  The Purchase Agreement also included representations and warranties, restrictive covenants and indemnification provisions standard for similar transactions.

The April 2015 Note bears interest at the rate of 10.0% per annum, with monthly installment payments of $45,000 commencing on the date that is 120 calendar days after the issuance date of the April 2015 Note.  At our option, subject to certain volume, price and other conditions, the monthly installments may be paid in whole, or in part, in cash or in Common Stock.  If the monthly installments are paid in Common Stock, such shares being issued will be based on a price that is 80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days.  The percentage declines to 70% if the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days is less than $0.05 per share.  The April 2015 Note is not subject to conversion at the discretion of Inter-Mountain.

At our option, the outstanding principal balance of the April 2015 Note, or a portion thereof, may be prepaid in cash at 120% of the amount elected to be prepaid.  The April 2015 Note is unsecured.

Events of default under the April 2015 Note include failure to make required payments, the entry of a $100,000 judgment not stayed within 30 days, breach of representations or covenants under the transaction documents, various events associated with insolvency or failure to pay debts, delisting of the Common Stock, a restatement of financial statements and a default under certain other agreements.  In the event of default, the interest rate under the April 2015 Note increases to 18% and the April 2015 Note becomes callable at a premium.  In addition, Inter-Mountain has all remedies under law and equity.

 
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As part of the debt financing, Inter-Mountain also received a warrant (the “Warrant”) to purchase up to an aggregate of 194,118 shares of Common Stock.  The Warrant has an exercise price of $0.85 per share and expires on April 30, 2020. The Warrant includes a standard net cashless exercise provision and provisions requiring proportionate adjustments in connection with a recapitalization transaction.

As part of the debt financing, we entered into a Registration Rights Agreement whereby we agreed to prepare and file with the Securities and Exchange Commission (the “SEC”) a registration statement no later than May 11, 2015 and to cause such registration statement to be declared effective no later than 120 after the closing date and to keep such registration statement effective for a period of no less than 180 days.  In accordance with our obligations under the Registration Rights Agreement, we filed with the SEC a registration statement that was declared effective on June 4, 2015.
 
In connection with the Purchase Agreement, the Company and Inter-Mountain entered into a Settlement Agreement (the “Settlement Agreement”) for the purpose of settling the pending litigation between the Company and Inter-Mountain in the U.S. Federal Court for the District of Utah, Central Division with respect to Inter-Mountain’s cashless exercise on May 1, 2014 of a warrant to purchase Common Stock issued in June 2012.  Under the Settlement Agreement and related documents, the Company and Inter-Mountain agreed that Inter-Mountain would exercise the warrant as part of closing and receive 361,516 shares of Common Stock.  The Settlement Agreement also included standard releases and anticipated the prompt filing of dismissal documents.

Purchase of Altrazeal Trading, GmbH – May 2015

On May 12, 2015, we entered into a Binding Term Sheet (the “Term Sheet”) with IPMD GmbH, an Austrian limited liability company, and Firnron Ltd., a Cypriot limited liability company (collectively, the “Seller”) related to our purchase of 75% of the share capital of Altrazeal Trading GmbH, an Austrian limited liability company (“Altrazeal Trading”).  Uluru currently owns the remaining 25% of share capital of Altrazeal Trading.  Altrazeal Trading is the distributor of Altrazeal® transforming powder dressing in European Union, Australia, New Zealand, Middle East (excluding Jordan and Syria), North Africa, Albania, Bosnia, Croatia, Kosovo, Macedonia, Montenegro, and Serbia.

Pursuant to the terms and conditions in the Term Sheet, the purchase price will be composed of 3,150,000 Euro for the purchase of the share capital of Altrazeal Trading and 88,834 Euro for the purchase of product inventory.  The purchase of the share capital of Altrazeal Trading will be paid in installments, with 1,147,200 Euro due at closing (of which 646,500 Euro will be paid with an offset of accounts receivable) and five installment payments of 500,700 Euro due by no later than June 30, 2015, August 31, 2015, October 31, 2015, and December 31, 2015.  The sale is structured as an “installment sale”, with 15% of equity in Altrazeal Trading being transferred upon the payment of each installment by us.  The installments are payable in either cash or in shares of our common stock at our option.  If installment payments are made in common stock, the calculation of shares to be issued will be 110% of the average closing price for the last 10 trading days prior to the installment payment date and include a warrant for 10% of the shares issued with a premium of $0.30 per share to the market price. The purchase of the product inventory for 88,834 Euro will be paid on September 30, 2015

To the extent we issue shares of common stock to pay the purchase price, we have agreed to register the resale of such shares to the extent possible. The Term Sheet anticipates the negotiation and execution of a purchase agreement containing all terms of the Term Sheet and other standard terms for such a transaction within 60 days.  Such 60 day period expired on July 21, 2015 but both parties are continuing in their efforts to finalize the negotiation and execution of a purchase agreement by no later than November 15, 2015.


RESULTS OF OPERATIONS

Fluctuations in Operating Results

Our results of operations have fluctuated significantly from period to period in the past and are likely to continue to do so in the future. We anticipate that our quarterly and annual results of operations will be impacted for the foreseeable future by several factors, including the timing and amount of payments received pursuant to our current and future collaborations, and the progress and timing of expenditures related to our development and commercialization efforts. Due to these fluctuations, we believe that the period-to-period comparisons of our operating results may not be a good indication of our future performance.

Comparison of the three months ended June 30, 2015 and 2014

Total Revenues

Revenues were approximately $259,000 for the three months ended June 30, 2015, as compared to revenues of approximately $209,000 for the three months ended June 30, 2014, and were composed of, in approximate amounts, licensing fees of $16,000 from Altrazeal® and OraDisc™ licensing agreements and product sales of $243,000 for Altrazeal®.

The increase of approximately $50,000 in revenues is primarily attributable to an increase of approximately $67,000 in Altrazeal® product sales to our international distributors.  This revenue increase was partially offset by a decrease of $17,000 in royalties from our international distributors.

 
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Costs and Expenses

Cost of Goods Sold

Cost of goods sold for the three months ended June 30, 2015 and 2014 were approximately $81,000 and $113,000, respectively, and were composed entirely of costs associated with Altrazeal®.

Research and Development

Research and development expenses totaled approximately $219,000 for the three months ended June 30, 2015, including $19,000 in share-based compensation, compared to approximately $184,000 for the three months ended June 30, 2014, which included $5,000 in share-based compensation.  The increase of approximately $35,000 in research and development expenses was primarily due to, in approximate numbers, an increase of $16,000 in scientific compensation related to share-based compensation and a higher head count, an increase of $8,000 in direct research costs primarily related to Altrazeal®, an increase of $7,000 in operating costs, and an increase of $4,000 in regulatory consulting costs.
 
The direct research and development expenses for the three months ended June 30, 2015 and 2014 were, in approximate numbers, as follows:

   
Three Months Ended June 30,
 
Technology
 
2015
   
2014
 
  Wound care & nanoparticle
  $ 71,000     $ 63,000  
  OraDisc™
    4,000       4,000  
  Aphthasol® & other technologies
    1,000       1,000  
  Total
  $ 76,000     $ 68,000  
 
Selling, General and Administrative

Selling, general and administrative expenses totaled approximately $495,000 for the three months ended June 30, 2015, including $51,000 in share-based compensation, compared to approximately $411,000 for the three months ended June 30, 2014, which included $17,000 in share-based compensation.  The increase of approximately $84,000 in selling, general and administrative expenses was primarily due to, in approximate numbers, an increase of $75,000 in marketing costs, an increase of $32,000 in directors fees related to share-based compensation, an increase of $7,000 in costs associated with financing activities, and an increase of $3,000 in insurance costs.  These expense increases were partially offset by, in approximate numbers, a decrease of $24,000 in legal costs due to the settlement of a licensing agreement dispute and a decrease of $9,000 in legal fees related to our patents.

Amortization of Intangible Assets

Amortization of intangible assets expense totaled approximately $118,000 for the three months ended June 30, 2015 as compared to approximately $118,000 for the three months ended June 30, 2014.  The expense for each period consists primarily of amortization associated with our acquired patents.  There were no additional purchases of patents during the three months ended June 30, 2015 and 2014, respectively.

Depreciation

Depreciation expense totaled approximately $46,000 for the three months ended June 30, 2015 as compared to approximately $60,000 for the three months ended June 30, 2014.  The decrease of approximately $14,000 is attributable to certain equipment being fully depreciated.

Interest and Miscellaneous Income

Interest and miscellaneous income totaled approximately $70 for the three months ended June 30, 2015 as compared to approximately $500 for the three months ended June 30, 2014

Interest Expense

Interest expense totaled approximately $63,000 for the three months ended June 30, 2015 as compared to approximately $33,000 for the three months ended June 30, 2014.  Interest expense typically includes financing costs for our insurance policies, interest costs related to regulatory fees, and interest costs and amortization of debt discount and debt issuance costs.  The increase of approximately $30,000 is primarily attributable to costs associated with our convertible debt and interest costs relating to regulatory fees.

Foreign Currency Transaction Gain

Foreign currency transaction gain totaled approximately $35,000 for the three months ended June 30, 2015 as compared to nil for the three months ended June 30, 2014.  The gain is related to the fluctuations in the Euro exchange rate experienced during 2014 and 2015 and the pricing of Altrazeal® to our international distributors being denominated in Euros.

 
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Comparison of the six months ended June 30, 2015 and 2014

Total Revenues

Revenues were approximately $554,000 for the six months ended June 30, 2015, as compared to revenues of approximately $311,000 for the six months ended June 30, 2014, and were composed of, in approximate amounts, licensing fees of $31,000 from Altrazeal® and OraDisc™ licensing agreements and product sales of $523,000 for Altrazeal®.

The increase of $243,000 in revenues is primarily attributable to an increase of approximately $258,000 in Altrazeal® product sales to our international distributors and an increase of $2,000 in license fees related to Altrazeal®.  These revenues increases were partially offset by a decrease of $17,000 in royalties from our international distributors.

Costs and Expenses

Cost of Goods Sold

Cost of goods sold for the six months ended June 30, 2015 and 2014 were approximately $183,000 and $154,000, respectively, and were composed entirely of costs associated with Altrazeal®.
 
Research and Development

Research and development expenses totaled approximately $423,000 for the six months ended June 30, 2015, including $37,000 in share-based compensation, compared to approximately $372,000 for the six months ended June 30, 2014, which included $11,000 in share-based compensation.  The increase of approximately $51,000 in research and development expenses was primarily due to, in approximate numbers, an increase of $37,000 in scientific compensation related to share-based compensation and a higher head count, an increase of $20,000 direct research costs primarily related to Altrazeal®, and an increase of $6,000 in operating costs.  These expense increases were partially offset by a decrease of $12,000 in regulatory consulting costs.
 
The direct research and development expenses for the six months ended June 30, 2015 and 2014 were, in approximate numbers, as follows:

   
Six months Ended June 30,
 
Technology
 
2015
   
2014
 
  Wound care & nanoparticle
  $ 143,000     $ 124,000  
  OraDisc™
    8,000       7,000  
  Aphthasol® & other technologies
    2,000       2,000  
  Total
  $ 153,000     $ 133,000  

Selling, General and Administrative

Selling, general and administrative expenses totaled approximately $941,000 for the six months ended June 30, 2015, including $108,000 in share-based compensation, compared to approximately $880,000 for the six months ended June 30, 2014, which included $36,000 in share-based compensation.  The increase of approximately $61,000 in selling, general and administrative expenses was primarily due to, in approximate numbers, an increase of $155,000 in marketing costs, an increase of $67,000 in directors fees related to share-based compensation, an increase of $11,000 in compensation cost primarily related to share-based compensation, an increase of $7,000 in costs associated with financing activities, an increase of $7,000 in accounting fees related to our annual audit, and an increase of $5,000 in insurance costs.  These expense increases were partially offset by, in approximate numbers, a decrease of $86,000 in investor relations consulting as the prior year included the recognition of a share-based compensation award, a decrease of $76,000 in legal costs due to settlement of a licensing agreement dispute, a decrease of $25,000 in commission costs relating to product licensing, and a decrease of $4,000 in legal fees related to our patents.

Amortization of Intangible Assets

Amortization of intangible assets expense totaled approximately $236,000 for the six months ended June 30, 2015 as compared to approximately $236,000 for the six months ended June 30, 2014.  The expense for each period consists primarily of amortization associated with our acquired patents.  There were no additional purchases of patents during the six months ended June 30, 2015 and 2014, respectively.

Depreciation

Depreciation expense totaled approximately $105,000 for the six months ended June 30, 2015 as compared to approximately $120,000 for the six months ended June 30, 2014.  The decrease of approximately $15,000 is attributable to certain equipment being fully depreciated.
 
 
- 25 -

 
Interest and Miscellaneous Income

Interest and miscellaneous income totaled approximately $200 for the six months ended June 30, 2015 as compared to approximately $5,000 for the six months ended June 30, 2014.  The decrease of approximately $4,800 is attributable to a decrease in interest income resulting from the deduction and offset in January 2014 of the outstanding notes receivable against the outstanding principle due on the convertible promissory note with Inter-Mountain.

Interest Expense (Income)

Interest expense totaled approximately $76,000 for the six months ended June 30, 2015 as compared to approximately $(3,000) for the six months ended June 30, 2014.  Interest expense typically includes financing costs for our insurance policies, interest costs related to regulatory fees, and interest costs and amortization of debt discount and debt issuance costs.  The increase of approximately $79,000 in interest expense is primarily attributable to the prior year expense including a credit of approximately $101,000 associated with the deduction and offset in January 2014 of the outstanding notes receivable against the outstanding principle due on the convertible promissory note with Inter-Mountain and the final payoff of the convertible promissory note with Inter-Mountain in March 2014.

Foreign Currency Transaction (Loss)

Foreign currency transaction loss totaled approximately $58,000 for the six months ended June 30, 2015 as compared to nil for the six months ended June 30, 2014.  The increase of approximately $58,000 is related to the fluctuations in the Euro exchange rate experienced during 2014 and 2015 and the pricing of Altrazeal® to our international distributors being denominated in Euros.

Loss on Early Extinguishment of Convertible Note

Loss on early extinguishment of convertible note was nil for the six months ended June 30, 2015 as compared to $135,000 for the six months ended June 30, 2014, with such loss in 2014 occurring as a result of our election to exercise our rights under the June 2012 Note and to offset amounts we owed to Inter-Mountain against amounts it owed to us under the Investor Notes.
 
LIQUIDITY AND CAPITAL RESOURCES

We have funded our operations primarily through the public and private sales of convertible debentures and Common Stock.  Product sales, royalty payments, contract research, licensing fees and milestone payments from our corporate alliances have provided, and are expected in the future to provide, funding for operations. Our principal source of liquidity is cash and cash equivalents.  As of June 30, 2015 our cash and cash equivalents were approximately $19,000 which is a decrease of approximately $531,000 as compared to our cash and cash equivalents at December 31, 2014 of approximately $550,000.  Our working capital (current assets less current liabilities) was approximately $(924,000) at June 30, 2015 as compared to our working capital at December 31, 2014 of approximately $(53,000).

Consolidated Cash Flow Data
   
Six Months Ended June 30,
 
Net Cash Provided by (Used in)
 
2015
   
2014
 
  Operating activities
  $ (1,026,000 )   $ (902,000 )
  Investing activities
    (1,000 )     (16,000 )
  Financing activities
    496,000       1,633,000  
  Net increase (decrease) in cash and cash equivalents
  $ (531,000 )   $ 715,000  

Operating Activities

For the six months ended June 30, 2015, net cash used in operating activities was approximately $1,026,000.  The principal components of net cash used for the six months ended June 30, 2015 were, in approximate numbers, our net loss of $1,468,000, an increase of $450,000 in accounts receivable related to higher international product sales, and an increase of $212,000 in inventory related to the manufacture of Altrazeal®.  Our net loss for the six months ended June 30, 2015 included substantial non-cash charges of approximately $504,000 in the form of share-based compensation, amortization of patents, amortization of debt discount, amortization of debt issuance costs, and depreciation.  The aforementioned net cash used for the six months ended June 30, 2015 was partially offset by, in approximate numbers, an increase of $450,000 in accounts payable due to timing of vendor payments, an increase of $54,000 in accrued liabilities due to compensation deferrals, an increase of $11,000 in accrued interest related to Inter-Mountain debt, an increase of $8,000 in deferred revenues, and a decrease of $77,000 in prepaid expenses related to insurance, listing fees, and consulting.

For the six months ended June 30, 2014, net cash used in operating activities was approximately $902,000.  The principal components of net cash used for the six months ended June 30, 2014 were, in approximate numbers, our net loss of $1,578,000, a decrease of $344,000 in accounts payable due to timing of vendor payments, a decrease of $152,000 in accrued liabilities related to compensation and insurance, a decrease of $29,000 in deferred revenues due to amortization of revenues, and an increase of $244,000 in accounts receivable.  Our net loss for the six months ended June 30, 2014 included substantial non-cash charges of approximately $584,000 in the form of share-based compensation, amortization of patents, depreciation, amortization of debt discount, amortization of deferred financings costs, interest due on convertible notes settled with common stock, common stock and warrants issued for services, and the loss on early extinguishment of a convertible note.  The aforementioned net cash used for the six months ended June 30, 2014 was partially offset by, in approximate numbers, a decrease of $778,000 in notes receivable due to our offset in January 2014 of all outstanding Investor Notes issued by Inter-Mountain, a decrease of $47,000 in inventory, and a decrease of $36,000 in prepaid expenses.
 
 
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Investing Activities

Net cash used in investing activities for the six months ended June 30, 2015 was approximately $1,000 and relates to the purchase of computer equipment.

Net cash used in investing activities for the six months ended June 30, 2014 was approximately $16,000 and relates to the purchase of manufacturing equipment.

Financing Activities

Net cash provided by financing activities for the six months ended June 30, 2015 was approximately $496,000 and was composed of $485,000 from the debt transaction with Inter-Mountain in April 2015 and an adjustment of $11,000 of offering costs associated with our sale of preferred stock in 2011.

Net cash provided by financing activities for the six month ended June 30, 2014 was approximately $1,633,000 and was composed of, in approximate numbers, the final funding of $500,000 from the sale of common stock and warrants pursuant to the January 2013 Offering,  the final funding $110,000 from the sale of common stock and warrants pursuant to the March 2013 Offering, the funding of $1,800,000 from the exercise of warrants to purchase 2,250,000 shares of common stock pursuant to the Implementation Agreement with Sacks and TPT, and the repayment of $777,000 of principle due on the convertible promissory note with Inter-Mountain attributable to the deduction and offset in January 2014 of the outstanding Investor Notes against the outstanding principle due on the convertible promissory note with Inter-Mountain.
 
Liquidity

As of June 30, 2015, we had cash and cash equivalents of approximately $19,000.  We expect to use our cash, cash equivalents, and investments on working capital, general corporate purposes, property and equipment, and the payment of contractual obligations.  Our long-term liquidity will depend to a great extent on our ability to fully commercialize our Altrazeal® and OraDisc™ technologies; therefore we are continuing to look both domestically and internationally for opportunities that will enable us to expand our business.  At this time, we cannot accurately predict the effect of certain developments on the rate of sales growth, if any, during 2015 and beyond, such as the speed and degree of market acceptance, the impact of competition, the effectiveness of the sales and marketing efforts of our licensees, and the outcome of our current efforts to develop, receive approval for, and successfully launch our near-term product candidates.

As of June 30, 2015, our net working capital (current assets less current liabilities) was approximately $(924,000).  Based on our liquidity as of June 30, 2015, we believe that our liquidity will not be sufficient to fund operations through the third quarter of 2015.  In order to continue to advance our business plan and outstanding obligations, we need to raise additional capital.  We will need capital in the immediate-term to fund our current operations.  In addition, in light of our stage of development and limited sales, we may need additional capital in the foreseeable future in order to expand our business and fund our operations.  We expect to seek funding through public and/or private offerings of debt and equity securities.  We may also seek capital from other sources, including contribution by others to joint ventures, or collaborative arrangements or licensing for the development, testing, manufacturing and marketing of products under development.  We have no agreements with respect to our potential receipt of additional capital.

Historically, we have been able to raise capital as needed to fund our operations at a base level, but we have generally not raised capital sufficient to fund unexpected occurrences, to cover projected expenses over the long term or to fund extensive research, marketing and development.  We are currently in discussions with various parties about potential financings, and management believes that we can raise capital as necessary for our near term needs; however, no party has signed any binding commitment to provided capital.  As a result, there is a risk that we will not be able to obtain capital as needed in the near term.  In addition, we will need to continue to seek capital from the market over the long term. To the extent we raise capital, it generally will be on terms that are dilutive to shareholders and may require the issuance of warrants or similar incentives, the agreement to restrictive covenants and/or the pledge of our assets as securities for debt financings.

Our future capital requirements and adequacy of available funds will depend on many factors including:

§ 
our ability to successfully commercialize our wound management products and the market acceptance of these products;
§ 
our ability to establish and maintain collaborative arrangements with corporate partners for the development and commercialization of certain product opportunities;
§ 
continued scientific progress in our development programs;
§ 
our ability to collect outstanding receivables;
§ 
the costs involved in filing, prosecuting and enforcing patent claims;
§ 
competing technological developments;
§ 
the trading volume and price of our capital stock;
§ 
the actions of parties whose consents, waivers or prompt responses are required for approval of a financing (such as parties with rights of first refusal or consent rights);
§ 
our general financial situation, including the amount of our indebtedness; and
§ 
the cost of manufacturing and production scale-up.


 
- 27 -

 
Contractual Obligations

The following table summarizes our outstanding contractual cash obligations as of June 30, 2015, which is composed of the April 2015 Note, a lease agreement for office and laboratory space in Addison, Texas, and a lease agreement for office equipment.  These obligations and commitments assume non-termination of agreements and represent expected payments based on current operating forecasts, which are subject to change:

   
Payments Due By Period
 
Contractual Obligations
 
Total
   
Less Than
1 Year
   
1-2
Years
   
3-5
Years
   
After 5
Years
 
  April 2015 Note
  $ 550,000     $ 495,000     $ 55,000     $ ---     $ ---  
  Operating leases
  $ 328,458     $ 119,840     $ 208,618     $ ---     $ ---  
  Total contractual cash obligations
  $ 878,458     $ 614,840     $ 263,618     $ ---     $ ---  

Capital Expenditures

For the six months ended June 30, 2015 and 2014, our expenditures for property, equipment, and leasehold improvements were, in approximate numbers, $1,000 and $16,000, respectively.  The expenditures in 2015 relate to the purchase of computer equipment and the expenditures in 2014 relate primarily to the purchase of equipment for the manufacture of Altrazeal®.  At this time, we believe that our capital expenditures for the remainder of 2015 will be approximately $59,000 and consist of equipment related to the manufacture of our products.

Off-Balance Sheet Arrangements

As of June 30, 2015, we did not have any off balance sheet arrangements.

Impact of Inflation

We have experienced only moderate price increases over the last three fiscal years under our agreements with third-party manufacturers as a result of raw material and labor price increases.  However, there can be no assurance that possible future inflation would not impact our operations.

Concentrations of Credit Risk

Concentration of credit risk with respect to financial instruments, consisting primarily of cash and cash equivalents, potentially expose us to concentrations of credit risk due to the use of a limited number of banking institutions and due to maintaining cash balances in banks, which, at times, may exceed the limits of amounts insured by the Federal Deposit Insurance Corporation.  Currently, we utilized Bank of America, N.A. as our banking institution.  At June 30, 2015 and December 31, 2014 our cash and cash equivalents totaled approximately $19,000 and $550,000, respectively.  We also invest cash in excess of immediate requirements in money market accounts, certificates of deposit, corporate commercial paper with high quality ratings, and U.S. government securities.  These investments are not held for trading or other speculative purposes.  We are exposed to credit risk in the event of default by these institutions.

Concentration of credit risk with respect to trade accounts receivable are customers with balances that exceed 5% of total consolidated trade accounts receivable at June 30, 2015 and at December 31, 2014.  As of June 30, 2015, three customers, each being one of our international distributors, exceeded the 5% threshold, with 83%, 12%, and 5%, respectively.  Three customers, each being one of our international distributors, exceeded the 5% threshold at December 31, 2014, with 71%, 19%, and 9%, respectively.  To reduce risk, we routinely assess the financial strength of our most significant customers and monitor the amounts owed to us, taking appropriate action when necessary.  As a result, we believe that accounts receivable credit risk exposure is limited.  We maintain an allowance for doubtful accounts, but historically have not experienced any significant losses related to an individual customer or group of customers.

Concentrations of Foreign Currency Risk

Currently, a portion of our revenues and all of our expenses are denominated in U.S. dollars. We are experiencing an increase in revenues in international territories denominated in a foreign currency.  Certain of our licensing and distribution agreements in international territories are denominated in Euros.  Currently, we do not employ forward contracts or other financial instruments to mitigate foreign currency risk.  As our international operations continue to grow, we may engage in hedging activities to hedge our exposure to foreign currency risk.

 
- 28 -



CRITICAL ACCOUNTING POLICIES AND ESTIMATES

Management’s Discussion and Analysis of Financial Condition and Results of Operations addresses our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information. The preparation of our financial statements requires that we make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. On an on-going basis, we evaluate these estimates and judgments. We base our estimates and judgments on historical experience and on various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.  Our critical accounting policies are summarized in our Annual Report on Form 10-K for the year ended December 31, 2014 as filed with the Securities and Exchange Commission on April 1, 2015.  We had no significant changes in our critical accounting policies since our last annual report.


SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This quarterly report on Form 10-Q (including documents incorporated by reference) and other written and oral statements the Company makes from time to time contain certain “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.  You can identify these forward-looking statements by the fact that they use words such as “should”, “expect”, “anticipate”, “estimate”, “target”, “may”, “project”, “guidance”, “will”, “intend”, “plan”, “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. One can also identify forward-looking statements by the fact that they do not relate strictly to historical or current facts.  Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes to differ materially from current expectations. These statements are likely to relate to, among other things, the Company’s goals, plans and projections regarding its financial position, statements indicating that the Company has cash and cash equivalents sufficient to fund our operations in the future, results of operations, cash flows, market position, product development, product approvals, sales efforts, expenses, performance or results of current and anticipated products and the outcome of contingencies such as legal proceedings, acquisitions, and financial results, which are based on current expectations that involve inherent risks and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years.
 
Although the Company believes it has been prudent in its plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statements can be achieved, and readers are cautioned not to place undue reliance on such statements, which speak only as of the date made.  We undertake no obligation to release publicly any revisions to forward-looking statements as a result of new information, future events or otherwise.
 

ITEM 3.
Quantitative and Qualitative Disclosures About Market Risk.

This item is not applicable to smaller reporting companies.


ITEM 4.
Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Based on their evaluation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the "Exchange Act")) as of the end of the period covered by this quarterly report, our chief executive officer and chief financial officer have concluded that our disclosure controls and procedures are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC's rules and forms and is accumulated and communicated to the Company's management, as appropriate, to allow timely decisions regarding required disclosure, and are operating in an effective manner.

Changes in Internal Controls Over Financial Reporting

During the fiscal quarter ended June 30, 2015, there were no changes in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 
- 29 -


PART II - OTHER INFORMATION


ITEM 1.
 Legal Proceedings.

On or about August 22, 2014, Inter-Mountain filed a Complaint against ULURU in the U.S. Federal Court for the District of Utah, Central Division.  The Complaint relates to Inter-Mountain’s delivery of a notice of a cashless exercise with respect to its last remaining warrant to purchase Common Stock on or about May 1, 2014 purporting to exercise it with respect to the delivery of 782,284 shares of Common Stock under the non-standard cashless exercise or conversion provisions in the warrant.  The Company declined to honor the exercise on the basis that, as a result of an amendment to the warrant agreed to in December 2013, the warrant was exercisable, on a cashless basis, with respect to only 261,516 shares of Common Stock as of May 1, 2014.  Inter-Mountain alleged that the Company’s refusal to honor the exercise constituted a breach of the warrant, breach of implied covenant of good faith and fair dealing, unjust enrichment, a violation of securities laws and common law fraud and seeking actual damages, consequential damages, treble damages, specific performance, attorneys’ fees and costs and other relief.  Answers and counterclaims were filed.

On April 15, 2015, the Company and Inter-Mountain entered into a Settlement Agreement for the purpose of settling the pending litigation between the Company and Inter-Mountain.  Under the Settlement Agreement and related documents, the Company and Inter-Mountain agreed that Inter-Mountain would exercise the warrant and receive 361,516 shares of Common Stock.  The Settlement Agreement also included standard releases and anticipated the prompt filing of dismissal documents.

From time to time, we may be involved in litigation relating to claims arising out of our operations in the normal course of business.  We are not currently a party to any legal proceedings, the adverse outcome of which, in management’s opinion, individually or in the aggregate, would have a material adverse effect on the results of our operations or financial position.  There are no material proceedings to which any director, officer or any of our affiliates, any owner of record or beneficially of more than five percent of any class of our voting securities, or any associate of any such director, officer, our affiliates, or security holder, is a party adverse to us or our consolidated subsidiary or has a material interest adverse thereto.

ITEM 1A.
 Risk Factors.

This item is not applicable to smaller reporting companies.  Information about certain risks associated with an investment in our Common Stock is found in Part I, Item 1A of our Annual Report on Form 10-K, as filed with the SEC on April 1, 2015.

ITEM 2.
Unregistered Sales of Equity Securities and Use of Proceeds.

None, other than as previously reported.

ITEM 3.
Defaults Upon Senior Securities.

None.

ITEM 4.
Mine Safety Disclosures.

Not applicable.

ITEM 5.
Other Information.

None.

 
- 30 -


 
ITEM 6.
Exhibits.

Exhibit Number
 
Description
3.1
 
Restated Articles of Incorporation dated November 5, 2007. (1)
3.2
 
Amended and Restated Bylaws dated December 5, 2008. (2)
4.1
 
Warrant to Purchase Shares of Common Stock dated April 14, 2015. (3)
10.1
 
Promissory Note dated April 14, 2015. (3)
10.2
 
Securities Purchase Agreement dated April 14, 2015 by and between ULURU Inc. and Inter-Mountain Capital Corp. (3)
10.3
 
Registration Rights Agreement dated April 14, 2015 by and between ULURU Inc. and Inter-Mountain Capital Corp. (3)
10.4
 
Binding Term Sheet dated May 12, 2015 by and between ULURU Inc., IPMD GmbH, and Firnron Ltd. (4)
101.INS
***
XBRL Instance Document
101.SCH
***
XBRL Taxonomy Extension Schema Document
101.CAL
***
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
***
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
***
XBRL Taxonomy Extension Label Linkbase Document
101.PRE
***
XBRL Taxonomy Extension Presentation Linkbase Document
---------------------------------------------------
(1)
 
Incorporated by reference to the Company’s Form 8-K filed on November 6, 2007.
(2)
 
Incorporated by reference to the Company’s Form 8-K filed on December 11, 2008.
(3)
 
Incorporated by reference to the Company’s Form 8-K filed on April 17, 2015.
(4)
 
Incorporated by reference to the Company’s Form S-1 Registration Statement filed on May 13, 2015.
 
*
Filed herewith.
 
**
Filed herewith.  This exhibit shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that Section nor shall it be deemed incorporated by reference in any filings under the Securities Act of 1933 or the Securities and Exchange Act of 1934.
 
***
Pursuant to Rule 406T of Regulation S-T, the XBRL-related information in Exhibit 101 to this Quarterly Report on Form 10-Q is deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, is deemed not filed for purposes of Section 18 of the Securities and Exchange Act of 1934, and otherwise is not subject to liability under these sections.

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 
ULURU Inc.
   
 Date:  August 14, 2015
 
By:
 /s/ Kerry P. Gray
 
   
Kerry P. Gray
   
Chief Executive Officer and President
   
(Principal Executive Officer)
   
   
 Date:  August 14, 2015
 
By:
 /s/ Terrance K. Wallberg
 
   
Terrance K. Wallberg
   
Chief Financial Officer and Vice President
   
(Principal Financial and Accounting Officer)
 
 
 
- 31 -

 

EX-10.5 2 ex_10-5.htm INDEMNIFICATION AGREEMENT (B. SACKS) ex_10-5.htm



 
ULURU Inc.
 
INDEMNIFICATION AGREEMENT
 

 
THIS INDEMNIFICATION AGREEMENT (the “Agreement”) is made and entered into as of July 27, 2015 between ULURU Inc., a Nevada corporation (the “Company”), and Bradley J. Sacks (“Indemnitee”).
 
WITNESSETH THAT:
 
WHEREAS, highly competent persons have become more reluctant to serve corporations as directors and officers or in other capacities unless they are provided with adequate protection through insurance or adequate indemnification against inordinate risks of claims and actions against them arising out of their service to and activities on behalf of the corporation;
 
WHEREAS, the Board of Directors of the Company (the “Board”) has determined that, in order to attract and retain qualified individuals, the Company will attempt to maintain on an ongoing basis, at its sole expense, liability insurance to protect persons serving the Company and its subsidiaries from certain liabilities.  Although the furnishing of such insurance has been a customary and widespread practice among United States-based corporations and other business enterprises, the Company believes that, given current market conditions and trends, such insurance may be available to it in the future only at higher premiums and with more exclusions.  At the same time, directors, officers, and other persons in service to corporations or business enterprises are being increasingly subjected to expensive and time-consuming litigation relating to, among other things, matters that traditionally would have been brought only against the Company or business enterprise itself.  The By-laws of the Company require indemnification of the directors, officers, employees, fiduciaries and agents of the Company.  Indemnitee may also be entitled to indemnification pursuant to Chapter 78 - Private Corporations, of the Nevada Revised Statutes (the “NRS”).  The NRS expressly provides that the indemnification provisions set forth therein are not exclusive, and thereby contemplate that contracts may be entered into between the Company and members of the Board with respect to indemnification;
 
WHEREAS, the uncertainties relating to such insurance and to indemnification have increased the difficulty of attracting and retaining such persons;
 
WHEREAS, the Board has determined that the increased difficulty in attracting and retaining such persons is detrimental to the best interests of the Company's stockholders and that the Company should act to assure such persons that there will be increased certainty of such protection in the future;
 
WHEREAS, it is reasonable, prudent and necessary for the Company contractually to obligate itself to indemnify, and to advance expenses on behalf of, such persons to the fullest extent permitted by applicable law so that they will serve or continue to serve the Company free from undue concern that they will not be so indemnified;
 
WHEREAS, this Agreement is a supplement to and in furtherance of any indemnification provisions in the Articles of Incorporation and/or the By-laws of the Company and any resolutions adopted pursuant thereto, and shall not be deemed a substitute therefore, nor to diminish or abrogate any rights of Indemnitee thereunder;
 
WHEREAS, Indemnitee does not regard the protection available under the NRS, the Company's By-laws and insurance as adequate in the present circumstances, and may not be willing to serve as an officer or a director without adequate protection, and the Company desires Indemnitee to serve in such capacity.  Indemnitee is willing to serve, continue to serve and to take on additional services for or on behalf of the Company on the condition that he be so indemnified; and
 

 
 

 

NOW, THEREFORE, in consideration of Indemnitee’s agreement to serve as a director from and after the date hereof, the parties hereto agree as follows:
 
1. Indemnity of Indemnitee.  The Company hereby agrees to hold harmless and indemnify Indemnitee to the fullest extent permitted by law, as such may be amended from time to time.  In furtherance of the foregoing indemnification, and without limiting the generality thereof:
 
(a) Proceedings Other Than Proceedings by or in the Right of the Company.  Indemnitee shall be entitled to the rights of indemnification provided in this Section l(a) if, by reason of his Corporate Status (as hereinafter defined), Indemnitee is, or is threatened to be made, a party to or participant in any Proceeding (as hereinafter defined) other than a Proceeding by or in the right of the Company.  Pursuant to this Section 1(a), the Company shall indemnify Indemnitee against all Expenses (as hereinafter defined), judgments, penalties, fines and amounts paid in settlement actually and reasonably incurred by him, or on his behalf, in connection with such Proceeding or any claim, issue or matter therein, if the Indemnitee acted in good faith and in a manner the Indemnitee reasonably believed to be in or not opposed to the best interests of the Company, and with respect to any criminal Proceeding, had no reasonable cause to believe Indemnitee’s conduct was unlawful.
 
(b) Proceedings by or in the Right of the Company.  Indemnitee shall be entitled to the rights of indemnification provided in this Section 1(b) if, by reason of his Corporate Status, the Indemnitee is, or is threatened to be made, a party to or participant in any Proceeding brought by or in the right of the Company.  Pursuant to this Section 1(b), the Company shall indemnify Indemnitee against all Expenses and amounts paid in settlement actually and reasonably incurred by Indemnitee, or on Indemnitee’s behalf, in connection with such Proceeding or any claim, issue or matters therein, if Indemnitee acted in good faith and in a manner Indemnitee reasonably believed to be in or not opposed to the best interests of the Company; provided, however, if applicable law so provides, no indemnification against such Expenses shall be made in respect of any claim, issue or matter in such Proceeding as to which Indemnitee shall have been adjudged by a court of competent jurisdiction, after exhaustion of all appeals therefrom, to be liable to the Company unless and to the extent that a court of competent jurisdiction shall determine that such indemnification may be made.
 
(c)            Indemnification under NRS 78.138.  Indemnitee shall be entitled to the rights of indemnification provided under Section 1(a) and Section 1(b) if Indemnitee is not liable pursuant to NRS 78.138.
 
(d)            Indemnification for Expenses of a Party Who is Wholly or Partly Successful.  Notwithstanding any other provision of this Agreement, to the extent that Indemnitee is, by reason of his Corporate Status, a party to and is successful, on the merits or otherwise, in any Proceeding, the Company shall indemnify Indemnitee to the maximum extent permitted by law, as such may be amended from time to time, against all Expenses actually and reasonably incurred by him or on his behalf in connection therewith.  If Indemnitee is not wholly successful in such Proceeding but is successful, on the merits or otherwise, as to one or more but less than all claims, issues or matters in such Proceeding, the Company shall indemnify Indemnitee against all Expenses actually and reasonably incurred by him or on his behalf in connection with each successfully resolved claim, issue or matter.  For purposes of this Section and without limitation, the termination of any claim, issue or matter in such a Proceeding by dismissal, with or without prejudice, shall be deemed to be a successful result as to such claim, issue or matter.
 
Additional Indemnity.  In addition to, and without regard to any limitations on, the indemnification provided for in Section 1 of this Agreement, the Company shall and hereby does indemnify and hold harmless Indemnitee, to the fullest extent permitted by law, as may be amended from time to time, against all Expenses, judgments, penalties, fines and amounts paid in settlement actually and reasonably incurred by him or on his behalf if, by reason of his Corporate Status, he is, or is threatened to be made, a party to or participant in any Proceeding (including a Proceeding by or in the right of the Company), including, without limitation, all liability arising out of the negligence or active or passive wrongdoing of Indemnitee.  The only limitation that shall exist upon the Company’s obligations pursuant to this Agreement shall be that the Company shall not be obligated to make any payment to Indemnitee that is finally determined (under the procedures, and subject to the presumptions, set forth in Sections 6 and 7 hereof) to be unlawful.
 
2. Contribution.
 
(a) Whether or not the indemnification provided in Sections 1 and 2 hereof is available, in respect of any threatened, pending or completed action, suit or proceeding in which the Company is jointly liable with Indemnitee (or would be if joined in such action, suit or proceeding), the Company shall pay the entire amount of any judgment or settlement of such action, suit or proceeding without requiring Indemnitee to contribute to such payment and the Company hereby waives and relinquishes any right of contribution it may have against Indemnitee.  The Company shall not enter into any settlement of any action, suit or proceeding in which the Company is jointly liable with Indemnitee (or would be if joined in such action, suit or proceeding) unless such settlement provides for a full and final release of all claims asserted against Indemnitee.
 
(b) Without diminishing or impairing the obligations of the Company set forth in the preceding subparagraph, if, for any reason, Indemnitee shall elect or be required to pay all or any portion of any judgment or settlement in any threatened, pending or completed action, suit or proceeding in which the Company is jointly liable with Indemnitee (or would be if joined in such action, suit or proceeding), the Company shall contribute to the amount of Expenses, judgments, fines and amounts paid in settlement actually and reasonably incurred and paid or payable by Indemnitee in proportion to the relative benefits received by the Company and all officers, directors or employees of the Company, other than Indemnitee, who are jointly liable with Indemnitee (or would be if joined in such action, suit or proceeding), on the one hand, and Indemnitee, on the other hand, from the transaction from which such action, suit or proceeding arose; provided, however, that the proportion determined on the basis of relative benefit may, to the extent necessary to conform to law, be further adjusted by reference to the relative fault of the Company and all officers, directors or employees of the Company other than Indemnitee who are jointly liable with Indemnitee (or would be if joined in such action, suit or proceeding), on the one hand, and Indemnitee, on the other hand, in connection with the events that resulted in such expenses, judgments, fines or settlement amounts, as well as any other equitable considerations which applicable law may require to be considered.  The relative fault of the Company and all officers, directors or employees of the Company, other than Indemnitee, who are jointly liable with Indemnitee (or would be if joined in such action, suit or proceeding), on the one hand, and Indemnitee, on the other hand, shall be determined by reference to, among other things, the degree to which their actions were motivated by intent to gain personal profit or advantage, the degree to which their liability is primary or secondary and the degree to which their conduct is active or passive.
 
(c) The Company hereby agrees to fully indemnify and hold Indemnitee harmless from any claims of contribution which may be brought by officers, directors or employees of the Company, other than Indemnitee, who may be jointly liable with Indemnitee.
 

 
 

 


 
(d) To the fullest extent permissible under applicable law, if the indemnification provided for in this Agreement is unavailable to Indemnitee for any reason whatsoever, the Company, in lieu of indemnifying Indemnitee, shall contribute to the amount incurred by Indemnitee, whether for judgments, fines, penalties, excise taxes, amounts paid or to be paid in settlement and/or for Expenses, in connection with any claim relating to an indemnifiable event under this Agreement, in such proportion as is deemed fair and reasonable in light of all of the circumstances of such Proceeding in order to reflect (i) the relative benefits received by the Company and Indemnitee as a result of the event(s) and/or transaction(s) giving cause to such Proceeding; and/or (ii) the relative fault of the Company (and its directors, officers, employees and agents) and Indemnitee in connection with such event(s) and/or transaction(s).
 
3. Indemnification for Expenses of a Witness.  Notwithstanding any other provision of this Agreement, to the extent that Indemnitee is, by reason of his Corporate Status, a witness, or is made (or asked) to respond to discovery requests, in any Proceeding to which Indemnitee is not a party, the Company shall indemnify Indemnitee against all Expenses actually and reasonably incurred by him or on his behalf in connection therewith.
 
4. Advancement of Expenses.  Notwithstanding any other provision of this Agreement, the Company shall advance all Expenses incurred by or on behalf of Indemnitee in connection with any Proceeding by reason of Indemnitee’s Corporate Status within thirty (30) days after the receipt by the Company of a statement or statements from Indemnitee requesting such advance or advances from time to time, whether prior to or after final disposition of such Proceeding.  Such statement or statements shall reasonably evidence the Expenses incurred by Indemnitee and, if required by law at the time of such advance, shall include or be preceded or accompanied by a written undertaking by or on behalf of Indemnitee to repay any Expenses advanced if it shall ultimately be determined by a court of competent jurisdiction that Indemnitee is not entitled to be indemnified against such Expenses.  Any advances and undertakings to repay pursuant to this Section 5 shall be unsecured and interest free.  In furtherance of the foregoing the Indemnitee hereby undertakes to repay such amounts advanced only if, and to the extent that, it shall ultimately be determined by a court of competent jurisdiction that the Indemnitee is not entitled to be indemnified by the Company as authorized by this Agreement.
 
5. Procedures and Presumptions for Determination of Entitlement to Indemnification.  It is the intent of this Agreement to secure for Indemnitee rights of indemnity that are as favorable as may be permitted under the NRS and public policy of the State of Nevada.  Accordingly, the parties agree that the following procedures and presumptions shall apply in the event of any question as to whether Indemnitee is entitled to indemnification under this Agreement:
 
(a) To obtain indemnification under this Agreement, Indemnitee shall submit to the Company a written request, including therein or therewith such documentation and information as is reasonably available to Indemnitee and is reasonably necessary to determine whether and to what extent Indemnitee is entitled to indemnification.  The Secretary of the Company shall, promptly upon receipt of such a request for indemnification, advise the Board in writing that Indemnitee has requested indemnification.  Notwithstanding the foregoing, any failure of Indemnitee to provide such a request to the Company, or to provide such a request in a timely fashion, shall not relieve the Company of any liability that it may have to Indemnitee unless, and to the extent that, the Company is actually and materially prejudiced as a direct result of such failure.
 
(b) Upon written request by Indemnitee for indemnification pursuant to the first sentence of Section 6(a) hereof, a determination with respect to Indemnitee’s entitlement thereto shall be made in the specific case by one of the following three methods, which shall be at the election of the Board:  (i) by a majority vote of a quorum consisting of Disinterested Directors (as hereinafter defined), (ii) if a majority vote of a quorum consisting of Disinterested Directors so orders, or if a quorum of Disinterested Directors cannot be obtained, by Independent Counsel (as hereinafter defined) in a written opinion to the Board, a copy of which shall be delivered to Indemnitee, or (iii) by the stockholders of the Company.
 
 
(c) Notwithstanding anything to the contrary set forth in this Agreement, if a request for indemnification is made after a Change in Control, at the election of Indemnitee made in writing to the Company, any determination required to be made pursuant to Section 6(b) above as to whether Indemnitee is entitled to indemnification shall be made by Independent Counsel selected as provided in this Section 6(c). The Independent Counsel shall be selected by Indemnitee, unless Indemnitee shall request that such selection be made by the Board. The party making the selection shall give written notice to the other party advising it of the identity of the Independent Counsel so selected. The party receiving such notice may, within seven (7) days after such written notice of selection shall have been given, deliver to the other party a written objection to such selection. Such objection may be asserted only on the ground that the Independent Counsel so selected does not meet the requirements of “Independent Counsel” as defined in Section 13 hereof, and the objection shall set forth with particularity the factual basis of such assertion.  Absent a proper and timely objection, the person so selected shall act as Independent Counsel.  If a written objection is made, the Independent Counsel so selected may not serve as Independent Counsel unless and until a court has determined that such objection is without merit.  If, within twenty (20) days after submission by Indemnitee of a written request for indemnification pursuant to Section 6(a) hereof, no Independent Counsel shall have been selected (or, if selected, such selection shall have been objected to) in accordance with this paragraph, then either the Company or Indemnitee may petition the courts of the State of Nevada or other court of competent jurisdiction for resolution of any objection which shall have been made by the Company or Indemnitee to the other’s selection of Independent Counsel and/or for the appointment as Independent Counsel of a person selected by the court or by such other person as the court shall designate, and the person with respect to whom an objection is favorably resolved or the person so appointed shall act as Independent Counsel under Section 6(c) hereof.  The Company shall pay any and all reasonable fees and expenses of Independent Counsel incurred by such Independent Counsel in connection with acting pursuant to Section 6(b) hereof.  The Company shall pay any and all reasonable and necessary fees and expenses incident to the procedures of this Section 6(c), regardless of the manner in which such Independent Counsel was selected or appointed.
 
(d) If the determination of entitlement to indemnification is to be made by Independent Counsel pursuant to Section 6(b) hereof, the Independent Counsel shall be selected as provided in this Section 6(d).  The Independent Counsel shall be selected by the Board.  Indemnitee may, within ten (10) days after such written notice of selection shall have been given, deliver to the Company a written objection to such selection; provided, however, that such objection may be asserted only on the ground that the Independent Counsel so selected does not meet the requirements of “Independent Counsel” as defined in Section 13 of this Agreement, and the objection shall set forth with particularity the factual basis of such assertion.  Absent a proper and timely objection, the person so selected shall act as Independent Counsel.  If a written objection is made and substantiated, the Independent Counsel selected may not serve as Independent Counsel unless and until such objection is withdrawn or a court has determined that such objection is without merit.  If, within twenty (20) days after submission by Indemnitee of a written request for indemnification pursuant to Section 6(a) hereof, no Independent Counsel shall have been selected (or, if selected, such selection shall have been objected to) in accordance with this paragraph, then either the Company or Indemnitee may petition the appropriate courts of the State of Nevada or other court of competent jurisdiction for resolution of any objection which shall have been made by Indemnitee to the Company’s selection of Independent Counsel and/or for the appointment as Independent Counsel of a person selected by the court or by such other person as the court shall designate, and the person with respect to whom an objection is favorably resolved or the person so appointed shall act as Independent Counsel under Section 6(b) hereof.  The Company shall pay any and all reasonable fees and expenses of Independent Counsel incurred by such Independent Counsel in connection with acting pursuant to Section 6(b) hereof, and the Company shall pay any and all reasonable fees and expenses incident to the procedures of this Section 6(d), regardless of the manner in which such Independent Counsel was selected or appointed.
 

 
 

 


(e) In making a determination with respect to entitlement to indemnification hereunder, the person or persons or entity making such determination shall presume that Indemnitee is entitled to indemnification under this Agreement.  Anyone seeking to overcome this presumption shall have the burden of proof and the burden of persuasion by clear and convincing evidence.  Neither the failure of the Company (including by its directors or independent legal counsel) to have made a determination prior to the commencement of any action pursuant to this Agreement that indemnification is proper in the circumstances because Indemnitee has met the applicable standard of conduct, nor an actual determination by the Company (including by its directors or independent legal counsel) that Indemnitee has not met such applicable standard of conduct, shall be a defense to the action or create a presumption that Indemnitee has not met the applicable standard of conduct.
 
(f) Indemnitee shall be deemed to have acted in good faith if Indemnitee’s action is based on the records or books of account of the Enterprise (as hereinafter defined), including financial statements, or on information supplied to Indemnitee by the officers of the Enterprise in the course of their duties, or on the advice of legal counsel for the Enterprise or on information or records given or reports made to the Enterprise by an independent certified public accountant or by an appraiser or other expert selected with reasonable care by the Enterprise.  In addition, the knowledge and/or actions, or failure to act, of any director, officer, agent or employee of the Enterprise shall not be imputed to Indemnitee for purposes of determining the right to indemnification under this Agreement.  Whether or not the foregoing provisions of this Section 6(f) are satisfied, it shall in any event be presumed that Indemnitee has at all times acted in good faith and in a manner he reasonably believed to be in or not opposed to the best interests of the Company.  Anyone seeking to overcome this presumption shall have the burden of proof and the burden of persuasion by clear and convincing evidence.
 
(g) Notwithstanding anything to the contrary set forth in this Agreement, if the person, persons or entity empowered or selected under Section 6 to determine whether Indemnitee is entitled to indemnification shall not have been appointed or shall not have made a determination within sixty (60) days after receipt by the Company of the request therefore, the requisite determination of entitlement to indemnification shall be deemed to have been made and Indemnitee shall be entitled to such indemnification, unless the Company establishes by written opinion of Independent Counsel that (i) a misstatement by Indemnitee of a material fact, or an omission of a material fact necessary to make Indemnitee’s statement not materially misleading, in connection with the request for indemnification, or (ii) a prohibition of such indemnification under applicable law; provided, however, that such 60-day period may be extended for a reasonable time, not to exceed an additional thirty (30) days, if the person, persons or entity making such determination with respect to entitlement to indemnification in good faith requires such additional time to obtain or evaluate documentation and/or information relating thereto; and provided, further, that the foregoing provisions of this Section 6(g) shall not apply if the determination of entitlement to indemnification is to be made by the stockholders pursuant to Section 6(b) of this Agreement and if (A) within fifteen (15) days after receipt by the Company of the request for such determination, the Disinterested Directors resolve as required by Section 6(b)(iii) of this Agreement to submit such determination to the stockholders for their consideration at an annual meeting thereof to be held within seventy-five (75) days after such receipt and such determination is made thereat, or (B) a special meeting of stockholders is called within fifteen (15) days after such receipt for the purpose of making such determination, such meeting is held for such purpose within sixty (60) days after having been so called and such determination is made thereat.
 
(h) Indemnitee shall cooperate with the person, persons or entity making such determination with respect to Indemnitee’s entitlement to indemnification, including providing to such person, persons or entity upon reasonable advance request any documentation or information which is not privileged or otherwise protected from disclosure and which is reasonably available to Indemnitee and reasonably necessary to such determination.  Any Independent Counsel or member of the Board or stockholder of the Company shall act reasonably and in good faith in making a determination regarding Indemnitee’s entitlement to indemnification under this Agreement.  Any costs or expenses (including attorneys’ fees and disbursements) incurred by Indemnitee in so cooperating with the person, persons or entity making such determination shall be borne by the Company (irrespective of the determination as to Indemnitee’s entitlement to indemnification) and the Company hereby indemnifies and agrees to hold Indemnitee harmless therefrom.
 
(i) The Company acknowledges that a settlement or other disposition, including a conviction or a plea of nolo contendere, short of final judgment may be successful if it permits a party to avoid expense, delay, distraction, disruption and uncertainty.  In the event that any action, claim or proceeding to which Indemnitee is a party is resolved in any manner other than by adverse judgment against Indemnitee (including, without limitation, settlement of such action, claim or proceeding with or without payment of money or other consideration) it shall be presumed that Indemnitee has been successful on the merits or otherwise in such action, suit or proceeding, and it shall not create a presumption that the Indemnitee did not act in good faith and in a manner reasonably believed to be in or not opposed to the best interest of the Company or that, with respect to any criminal Proceeding, the Indemnitee had reasonable cause to believe that his conduct unlawful.  Anyone seeking to overcome this presumption shall have the burden of proof and the burden of persuasion by clear and convincing evidence.
 
(j) The termination of any Proceeding or of any claim, issue or matter therein, by judgment, order, settlement or conviction, or upon a plea of nolo contendere or its equivalent, shall not of itself adversely affect the right of Indemnitee to indemnification or create a presumption that Indemnitee did not act in good faith and in a manner which he reasonably believed to be in or not opposed to the best interests of the Company or, with respect to any criminal Proceeding, that Indemnitee had reasonable cause to believe that his conduct was unlawful.
 
6. Remedies of Indemnitee.
 
(a) In the event that (i) a determination is made pursuant to Section 6 of this Agreement that Indemnitee is not entitled to indemnification under this Agreement, (ii) advancement of Expenses is not timely made pursuant to Section 5 of this Agreement, (iii) no determination of entitlement to indemnification is made pursuant to Section 6(b) or Section 6(c) of this Agreement within sixty (60) days after receipt by the Company of the request for indemnification, (iv) payment of indemnification is not made pursuant to this Agreement within ten (10) days after receipt by the Company of a written request therefor or (v) payment of indemnification is not made within ten (10) days after a determination has been made that Indemnitee is entitled to indemnification or such determination is deemed to have been made pursuant to Section 6 of this Agreement, Indemnitee shall be entitled to an adjudication of Indemnitee’s entitlement to such indemnification or advancement of expenses either, at the Indemnitee’s sole option, in (1) an appropriate court of the State of Nevada, or any other court of competent jurisdiction, or (2) an arbitration to be conducted by a single arbitrator, selected by mutual agreement of the Company and Indemnitee, pursuant to the rules of the American Arbitration Association. The Company shall not oppose Indemnitee’s right to seek any such adjudication.
 

 
 

 


 
(b) In the event that a determination shall have been made pursuant to Section 6(b) or Section 6(c) of this Agreement that Indemnitee is not entitled to indemnification, (i) any judicial proceeding or arbitration commenced pursuant to this Section 7 shall be conducted in all respects de novo on the merits, and Indemnitee shall not be prejudiced by reason of the adverse determination under Section 6(b) or Section 6(c); and (ii) in any such judicial proceeding or arbitration, the Company shall have the burden of proving that Indemnitee is not entitled to indemnification under this Agreement.
 
(c) If a determination shall have been made pursuant to Section 6(b) or Section 6(c), or shall have been deemed to have been made pursuant to Section 6(g), of this Agreement that Indemnitee is entitled to indemnification, the Company shall be obligated to pay the amounts constituting such indemnification within five (5) days after such determination has been made or has been deemed to have been made and shall be conclusively bound by such determination in any judicial proceeding commenced pursuant to this Section 7, unless the Company establishes by written opinion of Independent Counsel that (i) a misstatement by Indemnitee of a material fact, or an omission of a material fact necessary to make Indemnitee’s misstatement not materially misleading in connection with the request for indemnification, or (ii) a prohibition of such indemnification under applicable law.
 
(d) In the event that Indemnitee, pursuant to this Section 7, seeks a judicial adjudication of, or an award in arbitration to enforce, his rights under, or to recover damages for breach of, this Agreement, or to recover under any directors’ and officers’ liability insurance policies maintained by the Company, the Company shall pay to him or on his behalf, in advance, and shall indemnify him against, any and all expenses (of the types described in the definition of Expenses in Section 13 of this Agreement) actually and reasonably incurred by him in such judicial adjudication or arbitration, regardless of whether Indemnitee ultimately is determined to be entitled to such indemnification, advancement of expenses or insurance recovery.
 
(e) The Company shall be precluded from asserting in any judicial proceeding or arbitration commenced pursuant to this Section 7 that the procedures and presumptions of this Agreement are not valid, binding and enforceable and shall stipulate in any such court or before any such arbitrator that the Company is bound by all the provisions of this Agreement.  The Company shall indemnify Indemnitee against any and all Expenses and, if requested by Indemnitee, shall (within ten (10) days after receipt by the Company of a written request therefore) advance, to the extent not prohibited by law, such expenses to Indemnitee, which are incurred by Indemnitee in connection with any action brought by Indemnitee for indemnification or advance of Expenses from the Company under this Agreement or under any directors' and officers' liability insurance policies maintained by the Company, regardless of whether Indemnitee ultimately is determined to be entitled to such indemnification, advancement of Expenses or insurance recovery, as the case may be.
 
 
7. Non-Exclusivity; Survival of Rights; Insurance; Subrogation.
 
(a) The rights of indemnification and advancement of expenses as provided by this Agreement shall not be deemed exclusive of, and shall be in addition to, any other rights to which Indemnitee may at any time be entitled under applicable law, the Articles of Incorporation or By-laws of the Company, any agreement, a vote of stockholders, a resolution of directors or otherwise, and nothing in this Agreement shall diminish or otherwise restrict Indemnitee’s rights to indemnification or advancement of expenses under the foregoing.  No amendment, alteration or repeal of this Agreement or of any provision hereof shall limit or restrict any right of Indemnitee under this Agreement in respect of any action taken or omitted by such Indemnitee in his Corporate Status prior to such amendment, alteration or repeal.  To the extent that a change in the NRS, whether by statute or judicial decision, permits greater indemnification than would be afforded currently under the Company’s Articles of Incorporation, By-laws and this Agreement, it is the intent of the parties hereto that Indemnitee shall enjoy by this Agreement the greater benefits so afforded by such change and Indemnitee shall be deemed to have such greater benefits hereunder.  No right or remedy herein conferred is intended to be exclusive of any other right or remedy, and every other right and remedy shall be cumulative and in addition to every other right and remedy given hereunder or now or hereafter existing at law or in equity or otherwise.  The assertion or employment of any right or remedy hereunder, or otherwise, shall not prevent the concurrent assertion or employment of any other right or remedy.  The Company shall not adopt any amendments to its Articles of Incorporation or By-laws, the effect of which would be to deny, diminish or encumber Indemnitee’s right to indemnification or advancement of expenses under this Agreement, any other agreement or otherwise.
 
(b) To the extent that the Company maintains an insurance policy or policies providing liability insurance for directors, officers, employees, or agents or fiduciaries of the Company or of any other corporation, partnership, joint venture, trust, employee benefit plan or other enterprise that such person serves at the request of the Company, Indemnitee shall be covered by such policy or policies in accordance with its or their terms to the maximum extent of the coverage available for any director, officer, employee, agent or fiduciary under such policy or policies.  If, at the time of the receipt of a notice of a claim pursuant to the terms hereof, the Company has director and officer liability insurance in effect, the Company shall give prompt notice of the commencement of such proceeding to the insurers in accordance with the procedures set forth in the respective policies.  The Company shall thereafter take all necessary or desirable action to cause such insurers to pay, on behalf of Indemnitee, all amounts payable as a result of such proceeding in accordance with the terms of such policies.
 
(c) In the event of any payment under this Agreement, the Company shall be subrogated to the extent of such payment to all of the rights of recovery of Indemnitee, who shall execute all papers required and take all action necessary to secure such rights, including execution of such documents as are necessary to enable the Company to bring suit to enforce such rights (with all of Indemnitee’s reasonable expenses, including, without limitation, attorneys’ fees and charges, related thereto to be reimbursed by or, at the option of Indemnitee, advanced by the Company).
 
(d) The Company shall not be liable under this Agreement to make any payment of amounts otherwise indemnifiable hereunder if and to the extent that Indemnitee has otherwise actually received such payment under any insurance policy, contract, agreement or otherwise.
 
(e) The Company's obligation to indemnify or advance Expenses hereunder to Indemnitee who is or was serving at the request of the Company as a director, officer, employee or agent of any other corporation, partnership, joint venture, trust, employee benefit plan or other enterprise shall be reduced by any amount Indemnitee has actually received as indemnification or advancement of expenses from such other corporation, partnership, joint venture, trust, employee benefit plan or other enterprise.
 

 
 

 


 
8. Exception to Right of Indemnification. Notwithstanding any provision in this Agreement, the Company shall not be obligated under this Agreement to make any indemnity in connection with any claim made against Indemnitee:
 
(a) for which payment has actually been made to or on behalf of Indemnitee under any insurance policy or other indemnity provision, except with respect to any excess beyond the amount paid under any insurance policy or other indemnity provision; or
 
(b) for an accounting of profits made from the purchase and sale (or sale and purchase) by Indemnitee of securities of the Company within the meaning of Section 16(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or similar provisions of state statutory law or common law; or
 
(c) in connection with any Proceeding (or any part of any Proceeding) initiated by Indemnitee, including any Proceeding (or any part of any Proceeding) initiated by Indemnitee against the Company or its directors, officers, employees or other indemnitees, unless (i) the Board of the Company authorized the Proceeding (or any part of any Proceeding) prior to its initiation or (ii) the Company provides the indemnification, in its sole discretion, pursuant to the powers vested in the Company under applicable law.
 
9. Retroactive Effect; Duration of Agreement; Successors and Binding Agreement.  All agreements and obligations of the Company contained herein shall be deemed to have become effective upon the date Indemnitee first became an officer or director of the Company; shall continue during the period Indemnitee is an officer or a director of the Company (or is or was serving at the request of the Company as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise); and shall continue thereafter so long as Indemnitee may be subject to any Proceeding (or any proceeding commenced under Section 7 hereof) by reason of his Corporate Status, whether or not he is acting or serving in any such capacity at the time any liability or expense is incurred for which indemnification can be provided under this Agreement.  This Agreement shall be binding upon and inure to the benefit of and be enforceable by the parties hereto and their respective successors (including any direct or indirect successor by purchase, merger, consolidation, reorganization or otherwise to all or substantially all of the business or assets of the Company), assigns, spouses, heirs, executors and personal and legal representatives.  The Company shall require any such successor to all or substantially all of the business or assets of the Company, by agreement in form and substance satisfactory to Indemnitee and his counsel, expressly to assume and agree to perform this Agreement in the same manner and to the same extent the Company would be required to perform if no such succession had taken place.  Except as otherwise set forth in this Section 10, this Agreement shall not be assignable or delegable by the Company.
 
10. Security.  To the extent requested by Indemnitee and approved by the Board of the Company, the Company may at any time and from time to time provide security to Indemnitee for the Company’s obligations hereunder through an irrevocable bank line of credit, funded trust or other collateral.  Any such security, once provided to Indemnitee, may not be revoked or released without the prior written consent of the Indemnitee.
 
11. Enforcement.
 
(a) The Company expressly confirms and agrees that it has entered into this Agreement and assumes the obligations imposed on it hereby in order to induce Indemnitee to serve, or continue to serve, as an officer or a director of the Company, and the Company acknowledges that Indemnitee is relying upon this Agreement in serving as an officer or a director of the Company.
 
(b) This Agreement constitutes the entire agreement between the parties hereto with respect to the subject matter hereof and supersedes all prior agreements and understandings, oral, written and implied, between the parties hereto with respect to the subject matter hereof.
 
12. Definitions.  For purposes of this Agreement:
 
(a) Change in Control” means the occurrence of any one of the following events:
 
 
(i)           any “person” (as such term is defined in Section 3(a)(9) of the Exchange Act and as used in Sections 13(d)(3) and 14(d)(2) of the Exchange Act) is or becomes a “beneficial owner” (as defined in Rule 13d-3 under the Exchange Act), directly or indirectly, of securities of the Company representing 35% or more of the combined voting power of the Company’s then outstanding securities eligible to vote for the election of the Board (the “Company Voting Securities”); provided, however, that the event described in this paragraph (i) shall not be deemed to be a Change in Control by virtue of any of the following acquisitions:  (A) by the Company or any subsidiary; (B) by any employee benefit plan (or related trust) sponsored or maintained by the Company or any subsidiary; (C) by any underwriter temporarily holding securities pursuant to an offering of such securities; (D) pursuant to a Non-Control Transaction (as defined in paragraph (iii) below); or (E) a transaction (other than one described in paragraph (iii) below) in which Company Voting Securities are acquired from the Company, if a majority of the Incumbent Board (as defined in paragraph (ii) below) approves a resolution providing expressly that the acquisition pursuant to this clause (E) does not constitute a Change in Control under this paragraph (i);
 
(ii)           individuals who, on June 17, 2009, constitute the Board (the “Incumbent Board”) cease for any reason to constitute at least a majority thereof, provided that any person becoming a director subsequent to June 17, 2009, whose election or nomination for election was approved by a vote of at least two-thirds of the directors comprising the Incumbent Board (either by a specific vote or by approval of the proxy statement of the Company in which such person is named as a nominee for director, without objection to such nomination) shall be considered a member of the Incumbent Board; provided, however, that no individual initially elected or nominated as a director of the Company as a result of an actual or threatened election contest with respect to directors or any other actual or threatened solicitation of proxies or consents by or on behalf of any person other than the Board shall be deemed to be a member of the Incumbent Board;
 
(iii)           the consummation of a merger, consolidation, share exchange or similar form of corporate transaction involving the Company or any of its subsidiaries that requires the approval of the Company’s stockholders (whether for such transaction or the issuance of securities in the transaction or otherwise) (a “Reorganization”), unless immediately following such Reorganization:  (A) more than 60% of the total voting power of (x) the corporation resulting from such Reorganization (the “Surviving Company”), or (y) if applicable, the ultimate parent corporation that directly or indirectly has beneficial ownership of 95% of the voting securities eligible to elect directors of the Surviving Company (the “Parent Company”), is represented by Company Voting Securities that were outstanding immediately prior to such Reorganization (or, if applicable, is represented by shares into which such Company Voting Securities were converted pursuant to such Reorganization), and such voting power among the holders thereof is in substantially the same proportion as the voting power of such Company Voting Securities among holders thereof immediately prior to the Reorganization; (B) no person (other than any employee benefit plan (or related trust) sponsored or maintained by the Surviving Company or the Parent Company) is or becomes the beneficial owner, directly or indirectly, of 20% or more of the total voting power of the outstanding voting securities eligible to elect directors of the Parent Company (or, if there is no Parent Company, the Surviving Company); and (C) at least a majority of the members of the board of directors of the Parent Company (or, if there is no Parent Company, the Surviving Company) following the consummation of the Reorganization were members of the Incumbent Board at the time of the Board’s approval of the execution of the initial agreement providing for such Reorganization (any Reorganization which satisfies all of the criteria specified in (A), (B) and (C) above shall be deemed to be a “Non-Control Transaction”);

 
 

 

 

 
(iv)           the stockholders of the Company approve a plan of complete liquidation or dissolution; or
 
(v)           the consummation of a sale (or series of sales) of all or substantially all of the assets of the Company and its subsidiaries to an entity that is not an affiliate of the Company.
 
Notwithstanding the foregoing, a Change in Control shall not be deemed to occur solely because any person acquires beneficial ownership of 35% or more of the Company Voting Securities as a result of the acquisition of Company Voting Securities by the Company which reduces the number of Company Voting Securities outstanding; provided, that, if after such acquisition by the Company such person becomes the beneficial owner of additional Company Voting Securities that increases the percentage of outstanding Company Voting Securities beneficially owned by such person, a Change in Control shall then occur.
 

(b)            “Corporate Status” describes the status of a person who is or was a director, officer, employee, agent or fiduciary of the Company or of any other corporation, partnership, joint venture, trust, employee benefit plan or other enterprise that such person is or was serving at the request of the Company.
 
(c) Disinterested Director” means a director of the Company who is not and was not a party to the Proceeding in respect of which indemnification is sought by Indemnitee.
 
(d) Enterprise” shall mean the Company and any other corporation, partnership, joint venture, trust, employee benefit plan or other enterprise that Indemnitee is or was serving at the express written request of the Company as a director, officer, employee, agent or fiduciary.
 
(e) Expenses” shall include all reasonable attorneys’ fees, retainers, court costs, transcript costs, fees of experts, witness fees, travel expenses, duplicating costs, printing and binding costs, telephone charges, postage, delivery service fees and all other disbursements or expenses of the types customarily incurred or actually incurred in connection with prosecuting, defending, preparing to prosecute or defend, investigating, participating, or being or preparing to be a witness in a Proceeding, or responding to, or objecting to, a request to provide discovery in a Proceeding.  Expenses also shall include Expenses incurred in connection with any appeal resulting from any Proceeding, and any federal, state, local or foreign taxes imposed on the Indemnitee as a result of the actual or deemed receipt of any payments under this Agreement, including, without limitation, the premium, security for, and other costs relating to any cost bond, supersede as bond, or other appeal bond or its equivalent.  Expenses, however, shall not include amounts paid in settlement by Indemnitee or the amount of judgments or fines against Indemnitee.
 
(f) Independent Counsel” means a law firm, or a member of a law firm, that is experienced in matters of corporation law and neither presently is, nor in the past five (5) years has been, retained to represent:  (i) the Company or Indemnitee in any matter material to either such party (other than with respect to matters concerning Indemnitee under this Agreement, or of other indemnitees under similar indemnification agreements), or (ii) any other party to the Proceeding giving rise to a claim for indemnification hereunder.  Notwithstanding the foregoing, the term “Independent Counsel” shall not include any person who, under the applicable standards of professional conduct then prevailing, would have a conflict of interest in representing either the Company or Indemnitee in an action to determine Indemnitee’s rights under this Agreement.  The Company agrees to pay the reasonable fees of the Independent Counsel referred to above and to fully indemnify such counsel against any and all Expenses, claims, liabilities and damages arising out of or relating to this Agreement or its engagement pursuant hereto.
 
(g) Proceeding” includes any threatened, pending or completed action, suit, arbitration, alternate dispute resolution mechanism, investigation, inquiry, administrative hearing or any other actual, threatened or completed proceeding, whether brought by or in the right of the Company or otherwise and whether civil, criminal, administrative or investigative, in which Indemnitee was, is or will be involved as a party or otherwise, by reason of the fact that Indemnitee is or was an officer or a director of the Company, by reason of any action taken by him or of any inaction on his part while acting as an officer or a director of the Company, or by reason of the fact that he is or was serving at the request of the Company as a director, officer, employee, agent or fiduciary of another corporation, partnership, joint venture, trust or other Enterprise; in each case whether or not he is acting or serving in any such capacity at the time any liability or expense is incurred for which indemnification can be provided under this Agreement; including one pending on or before the date of this Agreement, but excluding one initiated by an Indemnitee pursuant to Section 7 of this Agreement to enforce his rights under this Agreement.
 
13. Severability.  The invalidity or unenforceability of any provision hereof shall in no way affect the validity or enforceability of any other provision.  Without limiting the generality of the foregoing, this Agreement is intended to confer upon Indemnitee indemnification rights to the fullest extent permitted by applicable laws.  In the event any provision hereof conflicts with any applicable law, such provision shall be deemed modified, consistent with the aforementioned intent, to the extent necessary to resolve such conflict.
 
14. Modification and Waiver.  No supplement, modification, termination or amendment of this Agreement shall be binding unless executed in writing by both of the parties hereto.  No waiver of any of the provisions of this Agreement shall be deemed or shall constitute a waiver of any other provisions hereof (whether or not similar) nor shall such waiver constitute a continuing waiver.
 
15. Notice By Indemnitee.  Indemnitee agrees promptly to notify the Company in writing upon being served with or otherwise receiving any summons, citation, subpoena, complaint, indictment, information or other document relating to any Proceeding or matter which may be subject to indemnification covered hereunder.  The failure to so notify the Company shall not relieve the Company of any obligation which it may have to Indemnitee under this Agreement unless, and only to the extent that, the Company is actually and materially prejudiced as a direct result of such delay or failure.
 
16. Notices.  All notices and other communications given or made pursuant to this Agreement shall be in writing and shall be deemed effectively given:  (a) upon personal delivery to the party to be notified, (b) when sent by confirmed electronic mail or facsimile if sent during normal business hours of the recipient, and if not so confirmed, then on the next business day, (c) five (5) days after having been sent by registered or certified mail, return receipt requested, postage prepaid, or (d) one (1) day after deposit with a nationally recognized overnight courier, specifying next day delivery, with written verification of receipt.  All communications shall be sent:
 
(a) To Indemnitee at the address set forth below Indemnitee’s signature hereto.
 
(b) To the Company at:
 
ULURU Inc.
4452 Beltway Drive
Addison, Texas 75001
Attention: Chief Financial Officer

or to such other address as may have been furnished to Indemnitee by the Company or to the Company by Indemnitee, as the case may be.
 

 
 

 


 
17. Counterparts.  This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same Agreement.  Executed counterparts may be delivered by facsimile and shall be deemed an original, but all of such counterparts  together shall constitute one and the same instrument.
 
18. Headings.  The headings of the paragraphs of this Agreement are inserted for convenience only and shall not be deemed to constitute part of this Agreement or to affect the construction thereof.
 
19.            Successors and Assigns.  The terms of this Agreement shall be binding upon the Company and its successors and assigns and shall inure to the benefit of Indemnitee and Indemnitee’s spouse, assigns, heirs, devisees, executors, administrators and other legal representatives.
 
20. Governing Law and Consent to Jurisdiction.  This Agreement and the legal relations among the parties shall be governed by, and construed and enforced in accordance with, the laws of the State of Nevada, without regard to its conflict of laws rules. The Company and Indemnitee hereby irrevocably and unconditionally (i) agree that any action or proceeding arising out of or in connection with this Agreement (other than an arbitration pursuant to Section 7 hereof) shall be brought only in the appropriate court of the State of Nevada (the “Nevada Court”), and not in any other state or federal court in the United States of America or any court in any other country, (ii) consent to submit to the exclusive jurisdiction of the Nevada Court for purposes of such action or proceeding, (iii) waive any objection to the laying of venue of any such action or proceeding in the Nevada Court, and (iv) waive, and agree not to plead or to make, any claim that any such action or proceeding brought in the Nevada Court has been brought in an improper or inconvenient forum.
 

 
SIGNATURE PAGE TO FOLLOW
 

 
 

 

IN WITNESS WHEREOF, the parties hereto have executed this Agreement on and as of the day and year first above written.
 
ULURU Inc.
 
 
By:
/s/ Kerry P. Gray 
 
 
Name:
Kerry P. Gray
 
 
Title:
President and Chief Executive Officer
 
       
       
       
INDEMNITEE
 
       
 
By:
/s/ Bradley J. Sacks  
 
Name:
Bradley J. Sacks
 
 
Address:
   
       
       
       



 
 

 

EX-31.1 3 ex_31-1.htm CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER ex_31-1.htm


EXHIBIT 31.1


Certification of Principal Executive Officer of ULURU Inc.
Pursuant to Rule 13a-14(a) and 15d-14(a) under
the Securities Exchange Act of 1934, as Amended

I, Kerry P. Gray, certify that:

1.
I have reviewed this Quarterly Report on Form 10-Q of ULURU Inc.;
   
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
   
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
   
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f) for the registrant and have:
   
 
(a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
   
 
(b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
   
 
(c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report, based on such evaluation; and
   
 
(d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
   
5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
   
 
(a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
   
 
(b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: August 14, 2015
 
/s/ Kerry P. Gray
 
 
Kerry P. Gray
 
 
President and Chief Executive Officer
 
(Principal Executive Officer)


 
 

 

EX-31.2 4 ex_31-2.htm CERTIFICATION OF PRINCIPAL ACCOUNTING OFFICER ex_31-2.htm


EXHIBIT 31.2

Certification of Principal Accounting Officer of ULURU Inc.
Pursuant to Rule 13a-14(a) and 15d-14(a) under
the Securities Exchange Act of 1934, as Amended

I, Terrance K. Wallberg, certify that:

1.
I have reviewed this Quarterly Report on Form 10-Q of ULURU Inc.;
   
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
   
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
   
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f) for the registrant and have:
   
 
(a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
   
 
(b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
   
 
(c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report, based on such evaluation; and
   
 
(d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
   
5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
   
 
(a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
   
 
(b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: August 14, 2015
 
/s/ Terrance K. Wallberg
 
 
Terrance K. Wallberg
 
 
Vice President and Chief Financial Officer
 
(Principal Financial and Accounting Officer)


 
 

 

EX-32.1 5 ex_32-1.htm CERTIFICATION OF CHIEF EXECUTIVE OFFICER ex_32-1.htm


 
EXHIBIT 32.1




Certification of Chief Executive Officer of ULURU Inc.
Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002



In connection with the Quarterly Report of ULURU Inc. (the “Company”) on Form 10-Q for the period ended June 30, 2015, as filed with the Securities and Exchange Commission and to which this Certification is an exhibit (the “Report”), the undersigned officer of ULURU Inc. does hereby certify, pursuant to Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. 1350), that to my knowledge:
   
(1.)
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
   
(2.)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

A signed original of this written statement required by Section 906 or other document authenticating, acknowledging or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.


Date: August 14, 2015
 
/s/ Kerry P. Gray
 
 
Kerry P. Gray
 
 
President and Chief Executive Officer
 
(Principal Executive Officer)


 
 

 

EX-32.2 6 ex_32-2.htm CERTIFICATION OF CHIEF FINANCIAL OFFICER ex_32-2.htm


 
EXHIBIT 32.2



Certification of Chief Financial Officer of ULURU Inc.
Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002



In connection with the Quarterly Report of ULURU Inc. (the “Company”) on Form 10-Q for the period ended June 30, 2015, as filed with the Securities and Exchange Commission and to which this Certification is an exhibit (the “Report”), the undersigned officer of ULURU Inc. does hereby certify, pursuant to Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. 1350), that to my knowledge:
   
(1.)
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
   
(2.)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

A signed original of this written statement required by Section 906 or other document authenticating, acknowledging or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.


Date: August 14, 2015
 
/s/ Terrance K. Wallberg
 
 
Terrance K. Wallberg
 
 
Vice President and Chief Financial Officer
 
(Principal Financial and Accounting Officer)





 
 

 

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font-family: times new roman; display: inline; width: 1%;">&#160;</td><td valign="bottom" style="font-size: 10pt; font-family: times new roman; text-align: left; width: 1%;">$</td><td valign="bottom" style="font-size: 10pt; font-family: times new roman; text-align: right; width: 9%;">1,039,343</td><td nowrap="nowrap" valign="bottom" style="font-size: 10pt; font-family: times new roman; text-align: left; width: 1%;">&#160;</td><td align="right" valign="bottom" style="font-size: 10pt; font-family: times new roman; display: inline; width: 1%;">&#160;</td><td valign="bottom" style="font-size: 10pt; font-family: times new roman; text-align: left; width: 1%;">$</td><td valign="bottom" style="font-size: 10pt; font-family: times new roman; text-align: right; width: 9%;">757,784</td><td nowrap="nowrap" valign="bottom" style="font-size: 10pt; font-family: times new roman; text-align: left; width: 1%;">&#160;</td></tr><tr bgcolor="white"><td align="left" valign="bottom" style="padding-left: 5%; width: 76%;"><div style="font-size: 10pt; 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margin-left: 0pt; display: block; margin-right: 0pt; text-indent: 0pt;">On or about August 22, 2014, Inter-Mountain Capital Corp. 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font-weight: bold; text-align: left; margin-left: 0pt; display: block; margin-right: 0pt; text-indent: 0pt;">NOTE 1.</div></td><td align="left" valign="top" style="width: 60%;"><div style="font-size: 10pt; font-family: times new roman; font-weight: bold; text-align: left; margin-left: 0pt; display: block; margin-right: 0pt; text-indent: 0pt;">COMPANY OVERVIEW AND BASIS OF PRESENTATION</div></td></tr></table></div><div style="display: block; text-indent: 0pt;"><br /></div><div style="font-size: 10pt; font-family: Times New Roman; text-align: justify; margin-left: 0pt; text-decoration: underline; display: block; margin-right: 0pt; text-indent: 0pt;">Company Overview</div><div style="display: block; text-indent: 0pt;"><br /></div><div style="font-size: 10pt; font-family: Times New Roman; text-align: justify; margin-left: 0pt; display: block; margin-right: 0pt; text-indent: 0pt;">ULURU Inc. (hereinafter &#8220;we&#8221;, &#8220;our&#8221;, &#8220;us&#8221;, &#8220;ULURU&#8221;, or the &#8220;Company&#8221;) is a Nevada corporation.&#160;&#160;We are a diversified specialty pharmaceutical company committed to developing and commercializing a broad range of innovative wound care and muco-adhesive film products based on our patented Nanoflex&#174; and OraDisc<font style="font-size: 70%; vertical-align: text-top; display: inline;">TM</font> technologies, with the goal of improving outcomes for patients, health care professionals, and health care payers.</div><div style="display: block; text-indent: 0pt;"><br /></div><div style="font-size: 10pt; font-family: Times New Roman; text-align: justify; margin-left: 0pt; text-decoration: underline; display: block; margin-right: 0pt; text-indent: 0pt;">Basis of Presentation</div><div style="display: block; text-indent: 0pt;"><br /></div><div style="font-size: 10pt; font-family: Times New Roman; text-align: justify; margin-left: 0pt; display: block; margin-right: 0pt; text-indent: 0pt;">In the opinion of management, the accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (&#8220;U.S. GAAP&#8221;) for interim financial information and with the instructions to Form 10-Q and include the accounts of ULURU Inc., a Nevada corporation, and its wholly-owned subsidiary, Uluru Delaware Inc., a Delaware corporation.&#160;&#160;They do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation of the Company&#8217;s financial position as of June 30, 2015 and the results of its operations for the three and six months ended June 30, 2015 and 2014 and cash flows for the six months ended June 30, 2015 and 2014 have been made.</div><div style="display: block; text-indent: 0pt;"><br /></div><div style="font-size: 10pt; font-family: Times New Roman; text-align: justify; margin-left: 0pt; display: block; margin-right: 0pt; text-indent: 0pt;">The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, as well as disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods.&#160;&#160;Actual results may differ from those estimates and assumptions.&#160;&#160;These differences are usually minor and are included in our consolidated financial statements as soon as they are known.&#160;&#160;Our estimates, judgments, and assumptions are continually evaluated based on available information and experience. 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text-indent: 0pt;">These condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto contained in the Company&#8217;s Annual Report on Form 10-K for the year ended December 31, 2014, as filed with the Securities and Exchange Commission on April 1, 2015, including the risk factors set forth therein.</div><div style="display: block; text-indent: 0pt;"><br /></div><div style="font-size: 10pt; font-family: Times New Roman; text-align: justify; margin-left: 0pt; text-decoration: underline; display: block; margin-right: 0pt; text-indent: 0pt;">Liquidity and Going Concern</div><div style="display: block; text-indent: 0pt;"><br /></div><div style="font-size: 10pt; font-family: Times New Roman; text-align: justify; margin-left: 0pt; display: block; margin-right: 0pt; text-indent: 0pt;">The report of our independent registered public accounting firm for the fiscal year ended December 31, 2014, contained an explanatory paragraph to reflect its significant doubt about our ability to continue as a going concern as a result of our history of losses and our liquidity position, as discussed herein and in this Form 10-Q.&#160;&#160;Based on our existing liquidity, the expected level of operating expenses, projected sales of our existing products combined with other revenues and financing transactions we are exploring, we believe that we do not have sufficient working capital to meet our working capital and capital expenditure requirements through the third quarter of 2015.&#160;&#160;In the long run we cannot be sure that our anticipated revenue growth will be realized or that we will generate significant positive cash flow from operations.&#160;&#160;Moreover, we may not be able to raise sufficient additional capital on acceptable returns, or at all, to continue operations and may not be able to execute any strategic transactions.&#160;&#160;Therefore, we are unable to assert that our financial position is sufficient to fund operations beyond the third quarter of 2015, and as a result, there is substantial doubt about our ability to continue as a going concern beyond the third quarter of 2015.</div></div> 0 279 787 16233 0.001 0.001 0 0 0 0 0 20000 20000 0 0 0 60713 137858 0 1800000 100000 300000 <div style="font-family: 'Times New Roman', Times, serif; 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Annual Sales, Certain Products [Member] An entity subject to receive payments from the Company for certain milestones based on the Company's achievement of annual net sales, cumulative net sales, and (or) our having reached certain defined technology milestones including licensing agreements and advancing products to clinical development. Access Pharmaceuticals [Member] As of the balance sheet date, the obligation the company owes to a third-party based upon certain milestones met by the company. Future milestone obligations Percentage of future payments received by the company that must be paid to a third party per license agreement termination. Royalty percentage Royalty percentage (in hundredths) Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table. 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Maximum Weighted Average Price Of Shares Of Common Stock Weighted average price of shares of common stock, Maximum (in dollars per share) Refers to percentage of the average of three lowest volume weighted average prices of the shares of common stock during the preceding twenty trading days. Percentage Of Weighted Average Prices Of Shares Of Common Stock Percentage of weighted average prices of shares of common stock (in hundredths) Promissory note is a written promise to pay a note. Promissory Note April 2015 [Member] Promissory Note April 2015 [Member] A patented product of the company. Amlexanox (OraDiscA) [Member] A patented product of the company. Hydrogel Nanoparticle Aggregate [Member] A patented product of the company. Amlexanox (Aphthasol) [Member] A major customer of the company designated by Customer C. Customer C [Member] A product category of the Company relating to Aphthasol. Aphthasol [Member] A product category of the Company relating to Altrazeal. 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Number of Shares Exercisable on Cashless Basis Number of shares exercisable on cashless basis (in shares) Refers to material proceedings to which any director, officer or any of our affiliates, any owner of record or beneficially of any class of our voting securities, or any associate of any such director, officer, our affiliates, or security holder, is a party adverse to us or our consolidated subsidiary or has a material interest adverse thereto. Maximum Percentage of Material Proceedings Interest to Beneficially of any Class of our Voting Securities Maximum percentage of material proceedings/interest (in hundredths) LEGAL PROCEEDINGS [Abstract] A range of exercise prices into which stock options are grouped. Exercise Price Range 3 [Member] A range of exercise prices into which stock options are grouped. Exercise Price Range 2 [Member] A range of exercise prices into which stock options are grouped. 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PROPERTY, EQUIPMENT and LEASEHOLD IMPROVEMENTS (Details) - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2015
Jun. 30, 2014
Jun. 30, 2015
Jun. 30, 2014
Dec. 31, 2014
Property, equipment and leasehold improvements, net [Abstract]          
Property, equipment and leasehold improvements, gross $ 2,278,596   $ 2,278,596   $ 2,277,809
Less: accumulated depreciation and amortization (1,950,226)   (1,950,226)   (1,845,699)
Property, equipment and leasehold improvements, net 328,370   328,370   432,110
Depreciation expense 46,218 $ 59,553 104,527 $ 120,107  
Laboratory Equipment [Member]          
Property, equipment and leasehold improvements, net [Abstract]          
Property, equipment and leasehold improvements, gross 424,888   424,888   424,888
Manufacturing Equipment [Member]          
Property, equipment and leasehold improvements, net [Abstract]          
Property, equipment and leasehold improvements, gross 1,599,894   1,599,894   1,599,894
Computers, Office Equipment, and Furniture [Member]          
Property, equipment and leasehold improvements, net [Abstract]          
Property, equipment and leasehold improvements, gross 153,865   153,865   153,078
Computer Software [Member]          
Property, equipment and leasehold improvements, net [Abstract]          
Property, equipment and leasehold improvements, gross 4,108   4,108   4,108
Leasehold Improvements [Member]          
Property, equipment and leasehold improvements, net [Abstract]          
Property, equipment and leasehold improvements, gross $ 95,841   $ 95,841   $ 95,841
XML 14 R48.htm IDEA: XBRL DOCUMENT v3.2.0.727
SHARE BASED COMPENSATION, Stock options grant outstanding and exercisable (Details) - Jun. 30, 2015 - $ / shares
Total
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items]  
Stock Options Outstanding (in shares) 1,664,573
Options Outstanding, Weighted Average Exercise Price per Share (in dollars per share) $ 1.73
Options Outstanding, Weighted Average Remaining Contractual Life in Years 7 years 3 months 18 days
Stock Options Exercisable (in shares) 819,573
Options Exercisable, Weighted Average Exercise Price per Share (in dollars per share) $ 2.57
Exercise Price Range 1 [Member]  
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items]  
Stock Options Outstanding (in shares) 882,500
Options Outstanding, Weighted Average Exercise Price per Share (in dollars per share) $ 0.33
Options Outstanding, Weighted Average Remaining Contractual Life in Years 7 years 8 months 12 days
Stock Options Exercisable (in shares) 640,000
Options Exercisable, Weighted Average Exercise Price per Share (in dollars per share) $ 0.33
Exercise Price Range 2 [Member]  
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items]  
Stock Options Outstanding (in shares) 680,000
Options Outstanding, Weighted Average Exercise Price per Share (in dollars per share) $ 1.15
Options Outstanding, Weighted Average Remaining Contractual Life in Years 7 years 4 months 24 days
Stock Options Exercisable (in shares) 77,500
Options Exercisable, Weighted Average Exercise Price per Share (in dollars per share) $ 1.15
Exercise Price Range 3 [Member]  
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items]  
Stock Options Outstanding (in shares) 33,334
Options Outstanding, Weighted Average Exercise Price per Share (in dollars per share) $ 2.55
Options Outstanding, Weighted Average Remaining Contractual Life in Years 4 years 9 months 18 days
Stock Options Exercisable (in shares) 33,334
Options Exercisable, Weighted Average Exercise Price per Share (in dollars per share) $ 2.55
Exercise Price Range 4 [Member]  
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items]  
Stock Options Outstanding (in shares) 68,739
Options Outstanding, Weighted Average Exercise Price per Share (in dollars per share) $ 25.07
Options Outstanding, Weighted Average Remaining Contractual Life in Years 2 years 1 month 6 days
Stock Options Exercisable (in shares) 68,739
Options Exercisable, Weighted Average Exercise Price per Share (in dollars per share) $ 25.07
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SHARE BASED COMPENSATION (Details) - USD ($)
3 Months Ended 6 Months Ended
Jun. 05, 2014
Jun. 13, 2013
Jun. 14, 2012
Jun. 15, 2010
Dec. 17, 2009
May. 08, 2007
Jun. 30, 2015
Jun. 30, 2014
Jun. 30, 2015
Jun. 30, 2014
Mar. 31, 2006
Additional disclosures [Abstract]                      
Number of shares authorized (in shares)             2,800,000   2,800,000    
Number of additional shares authorized (in shares) 1,000,000 600,000 400,000 200,000 200,000 266,667          
Incentive Stock Options [Member]                      
Options Granted [Abstract]                      
Quantity (in shares) [1]             0 0 0 0  
Weighted average fair value per share (in dollars per share) [1]             $ 0 $ 0 $ 0 $ 0  
Fair value [1]             $ 0 $ 0 $ 0 $ 0  
Options, Outstanding [Roll Forward]                      
Granted (in shares) [1]             0 0 0 0  
Nonstatutory Stock Options [Member]                      
Options Granted [Abstract]                      
Quantity (in shares) [2]             0 0 0 0  
Weighted average fair value per share (in dollars per share) [2]             $ 0 $ 0 $ 0 $ 0  
Fair value [2]             $ 0 $ 0 $ 0 $ 0  
Options, Outstanding [Roll Forward]                      
Granted (in shares) [2]             0 0 0 0  
Stock Options [Member]                      
Options Granted [Abstract]                      
Quantity (in shares)                 0    
Options, Outstanding [Roll Forward]                      
Outstanding, beginning of period (in shares)                 1,699,907    
Granted (in shares)                 0    
Forfeited/cancelled (in shares)                 (35,334)    
Exercised (in shares)                 0    
Outstanding, end of period (in shares)             1,664,573   1,664,573    
Outstanding, Weighted Average Exercise Price [Roll Forward]                      
Outstanding, beginning of period (in dollars per share)                 $ 1.73    
Granted (in dollars per share)                 0    
Forfeited/cancelled (in dollars per share)                 1.77    
Exercised (in dollars per share)                 0    
Outstanding, end of period (in dollars per share)             $ 1.73   $ 1.73    
Nonvested Awards, unearned share-based compensation [Abstract]                      
Unearned share-based compensation expense             $ 408,000   $ 408,000    
Unearned share-based compensation, recognition period                 27 months    
Stock Options [Member] | Maximum [Member]                      
Additional disclosures [Abstract]                      
Contractual term                 10 years    
Restricted Stock [Member]                      
Additional disclosures [Abstract]                      
Granted (in shares)             0 0 0 0  
Nonvested Awards, unearned share-based compensation [Abstract]                      
Unearned share-based compensation expense             $ 0   $ 0    
Restricted Stock [Member] | Minimum [Member]                      
Additional disclosures [Abstract]                      
Vesting period                 2 years    
Restricted Stock [Member] | Maximum [Member]                      
Additional disclosures [Abstract]                      
Vesting period                 5 years    
2006 Equity Incentive Plan [Member]                      
Additional disclosures [Abstract]                      
Number of shares authorized (in shares)                     133,333
Number of shares available for grant (in shares)             1,065,981   1,065,981    
2006 Equity Incentive Plan [Member] | Stock Options [Member]                      
Additional disclosures [Abstract]                      
Number of options granted to date (in shares)             2,061,167   2,061,167    
2006 Equity Incentive Plan [Member] | Stock Options [Member] | Minimum [Member]                      
Additional disclosures [Abstract]                      
Vesting period                 1 year    
2006 Equity Incentive Plan [Member] | Stock Options [Member] | Maximum [Member]                      
Additional disclosures [Abstract]                      
Vesting period                 4 years    
2006 Equity Incentive Plan [Member] | Restricted Stock [Member]                      
Additional disclosures [Abstract]                      
Number of restricted shares granted to date (in shares)             68,616   68,616    
2006 Equity Incentive Plan [Member] | Restricted Stock [Member] | Minimum [Member]                      
Additional disclosures [Abstract]                      
Vesting period                 6 months    
2006 Equity Incentive Plan [Member] | Restricted Stock [Member] | Maximum [Member]                      
Additional disclosures [Abstract]                      
Vesting period                 5 years    
[1] The Company did not award any incentive stock options for the three and six months ended June 30, 2015 and 2014, respectively.
[2] The Company did not award any nonstatutory stock options for the three and six months ended June 30, 2015 and 2014, respectively.
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EARNINGS PER SHARE (Tables)
6 Months Ended
Jun. 30, 2015
EARNINGS PER SHARE [Abstract]  
Common shares excluded from calculating basic and diluted net loss per common share
Shares used in calculating basic and diluted net loss per common share exclude these potential common shares as of June 30, 2015 and December 31, 2014:


   
June 30, 2015
  
December 31, 2014
 
Warrants to purchase Common Stock
  1,120,507   1,676,401 
Stock options to purchase common stock
  1,664,573   1,699,907 
Common stock issuable upon the assumed conversion of payments due under our promissory note from April 2015 (1)
  1,189,050   --- 
  Total
  3,974,130   3,376,308 

(1)
As part of the April 2015 Note, at our option, subject to certain volume, price and other conditions, the monthly installments of principle and interest due under the April 2015 Note may be paid in whole, or in part, in cash or in Common Stock.  If the monthly installments are paid in Common Stock, such shares being issued will be based on a price that is 80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days.  The percentage declines to 70% if the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days is less than $0.05 per share.  For the purposes of this Table, we have assumed that all outstanding monthly installments of principal and interest will be paid in Common Stock based on a price of $0.50 per share (80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days prior to June 30, 2015).
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SEGMENT INFORMATION (Tables)
6 Months Ended
Jun. 30, 2015
SEGMENT INFORMATION [Abstract]  
Revenues per geographic area
Revenues per geographic area, along with relative percentages of total revenues, for the three and six months ended June 30 are summarized as follows:

   
Three Months Ended June 30,
  
Six Months Ended June 30,
 
Revenues
 
2015
  
%
  
2014
  
%
  
2015
  
%
  
2014
  
%
 
Domestic
 $7,085   3% $11,770   6% $13,887   3% $21,442   7%
International
  251,912   97%  197,524   94%  539,758   97%  289,833   93%
Total
 $258,997   100% $209,294   100% $553,645   100% $311,275   100%
Customers with greater than 10% of total sales
A significant portion of our revenues are derived from a few major customers.  Customers with greater than 10% of total sales, along with their relative percentage of all sales, for the three and six months ended June 30 are represented on the following table:

     
Three Months Ended June 30,
  
Six Months Ended June 30,
 
Customers
Product
 
2015
  
2014
  
2015
  
2014
 
  Customer A
Altrazeal®
  91%  87%  92%  59%
  Customer B
Altrazeal®
  2%  3%  2%  28%
  Total
    93%  90%  94%  87%
XML 20 R50.htm IDEA: XBRL DOCUMENT v3.2.0.727
COMMITMENTS AND CONTINGENCIES (Details)
3 Months Ended 6 Months Ended 12 Months Ended 24 Months Ended 36 Months Ended 60 Months Ended
May. 12, 2015
EUR (€)
$ / shares
May. 12, 2015
EUR (€)
Installment
Mar. 17, 2015
USD ($)
Jun. 30, 2015
USD ($)
Jun. 30, 2014
USD ($)
Jun. 30, 2015
USD ($)
Jun. 30, 2015
EUR (€)
Jun. 30, 2014
USD ($)
Jun. 30, 2013
USD ($)
Jun. 30, 2012
USD ($)
Jun. 30, 2011
USD ($)
Dec. 31, 2014
USD ($)
Mar. 31, 2013
USD ($)
Feb. 01, 2018
USD ($)
Mar. 31, 2011
USD ($)
Sep. 30, 2015
EUR (€)
Mar. 07, 2008
USD ($)
Future minimum lease payments [Abstract]                                  
2015 (Six months)       $ 59,920   $ 59,920                      
2016       119,840   119,840                      
2017       119,840   119,840                      
2018       28,858   28,858                      
2019       0   0                      
Total       328,458   328,458                      
Rent expense for operating lease       29,837 $ 30,446 61,002   $ 60,826                  
Related Party Obligations [Abstract]                                  
Outstanding accounts receivable       $ 1,249,683   $ 1,249,683           $ 798,147          
Concentration risk, percentage (in hundredths)       100.00% 100.00% 100.00% 100.00% 100.00%                  
Summary of compensation earned, compensation paid in cash, and compensation temporarily deferred [Abstract]                                  
Deferred compensation liability           $ 166,772   $ (144,986) $ (126,769) $ 244,903 $ 176,852            
Deferred compensation       $ 316,772   316,772           150,000          
Compensation accounts payable       192,500   192,500           87,500          
Compensation accrued liabilities       124,272   124,272           62,500          
Milestone payments [Line Items]                                  
Future milestone obligations       4,750,000   4,750,000                      
Kerry P. Gray [Member]                                  
Summary of compensation earned, compensation paid in cash, and compensation temporarily deferred [Abstract]                                  
Deferred compensation liability [1],[2],[3]           151,806   (119,986) (91,000) 220,673 140,313            
Deferred compensation       301,806 [1],[2],[3] $ 150,000 301,806 [1],[2],[3]   150,000 221,500                
Deferred compensation liability pursuant to separation agreement                 11,500                
Deferred compensation liability pursuant to duties as president           46,806   62,500                  
Deferred compensation liability pursuant to duties as chairman           105,000   87,500 210,000                
Repayment of temporarily deferred compensation               269,986 312,500                
Proceeds from issuance of common stock under March 2013 offering               100,000 300,000                
Terrance K. Wallberg [Member]                                  
Summary of compensation earned, compensation paid in cash, and compensation temporarily deferred [Abstract]                                  
Deferred compensation liability           14,966   (25,000) $ (35,769) $ 24,230 $ 36,539            
Deferred compensation       14,996   14,996                      
Altrazeal Trading GmbH [Member]                                  
Related Party Obligations [Abstract]                                  
Related party sales           527,000   $ 278,000                  
Outstanding accounts receivable       $ 1,250,000   $ 1,250,000           $ 798,000          
Percentage of voting interest acquired (in hundredths) 75.00% 75.00%   25.00%   25.00%                      
Purchase price allocation, share capital | € € 3,150,000 € 3,150,000                              
Purchase price allocation, working capital | € € 88,834 88,834                              
Purchase price of acquisition, installment amount | €   1,147,200                              
Purchase price offset of accounts receivable amount | €   € 646,500                              
Number of installments | Installment   5                              
Purchase price of share capital, installment amount | €             € 500,700                    
Percentage of equity being transferred on each installment (in hundredths)   15.00%                              
Percentage of average closing price of shares (in hundredths)   110.00%                              
Number of trading days   10 days                              
Percentage of warrants included in installment payment (in hundredths)   10.00%                              
Premium per share included in installment payments (in dollars per share) | $ / shares € 0.30                                
Altrazeal Trading GmbH [Member] | Maximum [Member]                                  
Related Party Obligations [Abstract]                                  
Purchase agreement execution period   60 days                              
Altrazeal Trading GmbH [Member] | Subsequent Event [Member]                                  
Related Party Obligations [Abstract]                                  
Payment for inventory included in working capital | €                               € 88,834  
Altrazeal Trading GmbH [Member] | Sales Revenue, Goods, Net [Member]                                  
Related Party Obligations [Abstract]                                  
Concentration risk, percentage (in hundredths)           95.00% 95.00% 89.00%                  
Altrazeal Trading GmbH [Member] | Accounts Receivable [Member]                                  
Related Party Obligations [Abstract]                                  
Concentration risk, percentage (in hundredths)           99.80% 99.80%         99.50%          
Office and Laboratory Space [Member]                                  
Operating Leased Assets [Line Items]                                  
Minimum monthly lease obligation     $ 9,436         $ 9,193         $ 9,776   $ 9,330    
Future minimum monthly lease obligation after specified period           $ 9,379                      
Office Equipment [Member]                                  
Operating Leased Assets [Line Items]                                  
Minimum monthly lease obligation           744                      
Office Equipment [Member] | Subsequent Event [Member]                                  
Operating Leased Assets [Line Items]                                  
Minimum monthly lease obligation                           $ 551      
Access Pharmaceuticals [Member] | Annual Sales, Certain Products [Member] | Minimum [Member]                                  
Milestone payments [Line Items]                                  
Milestone for payment           20,000,000                      
Access Pharmaceuticals [Member] | Annual Sales, Certain Products [Member] | Maximum [Member]                                  
Milestone payments [Line Items]                                  
Milestone for payment           40,000,000                      
Access Pharmaceuticals [Member] | Annual Sales, Any One Certain Product [Member]                                  
Milestone payments [Line Items]                                  
Milestone for payment           20,000,000                      
Access Pharmaceuticals [Member] | Cumulative Sales, Certain Products [Member] | Minimum [Member]                                  
Milestone payments [Line Items]                                  
Milestone for payment           50,000,000                      
Access Pharmaceuticals [Member] | Cumulative Sales, Certain Products [Member] | Maximum [Member]                                  
Milestone payments [Line Items]                                  
Milestone for payment           $ 100,000,000                      
ProStrakan Ltd [Member]                                  
Milestone payments [Line Items]                                  
Royalty percentage (in hundredths)                                 30.00%
ProStrakan Ltd [Member] | Maximum [Member]                                  
Milestone payments [Line Items]                                  
Future milestone obligations                                 $ 1,400,000
[1] During 2013, Mr. Gray temporarily deferred compensation of 221,500 which consisted of 11,500 earned pursuant to a Separation Agreement and $210,000 for his duties as Chairman of the Executive Committee of the Company's Board of Directors. During 2013, Mr. Gray was also repaid $312,500 of temporarily deferred compensation, of which $300,000 was used by Mr. Gray for funding required pursuant to the March 2013 Offering.
[2] During 2014, Mr. Gray temporarily deferred compensation of $150,000 which consisted of 62,500 earned as salary compensation for his duties as President of the Company and $87,500 for his duties as Chairman of the Executive Committee of the Company's Board of Directors. During 2014, Mr. Gray was also repaid $269,986 of temporarily deferred compensation, of which $100,000 was used by Mr. Gray for funding required pursuant to the March 2013 Offering.
[3] During 2015, Mr. Gray temporarily deferred compensation of 151,806 which consisted of $46,806 earned as salary compensation for his duties as President of the Company and $105,000 for his duties as Chairman of the Executive Committee of the Company's Board of Directors.
XML 21 R42.htm IDEA: XBRL DOCUMENT v3.2.0.727
ACCRUED LIABILITIES (Details) - USD ($)
Jun. 30, 2015
Dec. 31, 2014
Accrued liabilities [Abstract]    
Accrued taxes - payroll $ 106,299 $ 106,299
Accrued compensation/benefits 208,678 96,795
Accrued insurance payable 6,616 69,815
Accrued property taxes 5,400 0
Product rebates/returns 8 13
Other 0 279
Total accrued liabilities $ 327,001 $ 273,201
XML 22 R37.htm IDEA: XBRL DOCUMENT v3.2.0.727
SEGMENT INFORMATION (Details)
3 Months Ended 6 Months Ended
Jun. 30, 2015
USD ($)
Jun. 30, 2014
USD ($)
Jun. 30, 2015
USD ($)
Segment
Licensee
Jun. 30, 2014
USD ($)
SEGMENT INFORMATION [Abstract]        
Number of business segments | Segment     1  
Number of international licensees | Licensee     7  
Revenues per geographic area [Abstract]        
Total Revenues $ 258,997 $ 209,294 $ 553,645 $ 311,275
Total revenue, percentage (in hundredths) 100.00% 100.00% 100.00% 100.00%
Revenue, Major Customer [Line Items]        
Sales from major customer, percentage (in hundredths) 93.00% 90.00% 94.00% 87.00%
Customer A [Member] | Altrazeal [Member]        
Revenue, Major Customer [Line Items]        
Sales from major customer, percentage (in hundredths) 91.00% 87.00% 92.00% 59.00%
Customer B [Member] | Altrazeal [Member]        
Revenue, Major Customer [Line Items]        
Sales from major customer, percentage (in hundredths) 2.00% 3.00% 2.00% 28.00%
Reportable Geographical Components [Member] | Domestic [Member]        
Revenues per geographic area [Abstract]        
Total Revenues $ 7,085 $ 11,770 $ 13,887 $ 21,442
Total revenue, percentage (in hundredths) 3.00% 6.00% 3.00% 7.00%
Reportable Geographical Components [Member] | International [Member]        
Revenues per geographic area [Abstract]        
Total Revenues $ 251,912 $ 197,524 $ 539,758 $ 289,833
Total revenue, percentage (in hundredths) 97.00% 94.00% 97.00% 93.00%
XML 23 R47.htm IDEA: XBRL DOCUMENT v3.2.0.727
SHARE BASED COMPENSATION, Allocated Compensation expense (Details) - Stock Options [Member] - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2015
Jun. 30, 2014
Jun. 30, 2015
Jun. 30, 2014
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]        
Share-based compensation expense $ 69,838 $ 22,383 $ 145,186 $ 46,923
Research and Development [Member]        
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]        
Share-based compensation expense 18,819 5,365 37,431 10,672
Selling, General and Administrative [Member]        
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]        
Share-based compensation expense $ 51,019 $ 17,018 $ 107,755 $ 36,251
XML 24 R9.htm IDEA: XBRL DOCUMENT v3.2.0.727
SEGMENT INFORMATION
6 Months Ended
Jun. 30, 2015
SEGMENT INFORMATION [Abstract]  
SEGMENT INFORMATION
NOTE 4.
SEGMENT INFORMATION

We operate in one business segment: the research, development and commercialization of pharmaceutical products.  Our corporate headquarters in the United States collects product sales, licensing fees, royalties, and sponsored research revenues from our arrangements with external customers and licensees.  Our entire business is managed by a single management team, which reports to the Chief Executive Officer.

Our revenues are currently derived primarily from seven licensees for international activities and our domestic sales activities of Altrazeal®.

Revenues per geographic area, along with relative percentages of total revenues, for the three and six months ended June 30 are summarized as follows:

   
Three Months Ended June 30,
  
Six Months Ended June 30,
 
Revenues
 
2015
  
%
  
2014
  
%
  
2015
  
%
  
2014
  
%
 
Domestic
 $7,085   3% $11,770   6% $13,887   3% $21,442   7%
International
  251,912   97%  197,524   94%  539,758   97%  289,833   93%
Total
 $258,997   100% $209,294   100% $553,645   100% $311,275   100%

A significant portion of our revenues are derived from a few major customers.  Customers with greater than 10% of total sales, along with their relative percentage of all sales, for the three and six months ended June 30 are represented on the following table:

     
Three Months Ended June 30,
  
Six Months Ended June 30,
 
Customers
Product
 
2015
  
2014
  
2015
  
2014
 
  Customer A
Altrazeal®
  91%  87%  92%  59%
  Customer B
Altrazeal®
  2%  3%  2%  28%
  Total
    93%  90%  94%  87%
XML 25 R43.htm IDEA: XBRL DOCUMENT v3.2.0.727
PROMISSORY NOTE PAYABLE (Details) - USD ($)
3 Months Ended 6 Months Ended
Apr. 15, 2015
Jun. 30, 2015
Jun. 30, 2014
Jun. 30, 2015
Jun. 30, 2014
Debt Instrument [Line Items]          
Promissory note original issue discount   $ 58,100   $ 58,100  
Warrant to purchase shares of common stock (in shares) 361,516        
Warrants expiration date       Apr. 30, 2020  
Initial Principal Amount   $ 550,000   $ 550,000  
Conversion Price [1]   $ 0   $ 0  
Principal Balance   $ 550,000   $ 550,000  
Unamortized Debt Discount   58,100   58,100  
Unamortized Debt Issuance Costs       41,897  
Carrying Value   450,003   450,003  
Accrued interest from promissory note and convertible notes payable   11,764 $ 5,952 11,764 $ 19,897
Amortization of debt discount on promissory note and convertible note   11,035 $ 2,655 11,035 $ (78,630)
2014 (Six Months)   225,000   225,000  
2015   325,000   325,000  
2016   0   0  
2017   0   0  
2018   0   0  
April 2015 Note [Member]          
Debt Instrument [Line Items]          
Promissory note original issue discount   58,100   58,100  
Initial Principal Amount   $ 550,000   $ 550,000  
Interest Rate   10.00%   10.00%  
Maturity Date       Aug. 12, 2016  
Conversion Price [1]   $ 0   $ 0  
Principal Balance   $ 550,000   $ 550,000  
Unamortized Debt Discount   58,100   58,100  
Unamortized Debt Issuance Costs       41,897  
Carrying Value   450,003   450,003  
2014 (Six Months)   225,000   225,000  
2015   325,000   325,000  
2016   0   0  
2017   0   0  
2018   $ 0   $ 0  
Inter Mountain Capital Corp [Member]          
Debt Instrument [Line Items]          
Promissory note original issue discount $ 50,000        
Purchase price for promissory note 500,000        
Promissory note monthly installment payments $ 45,000        
Monthly installment payments commencing period 120 days        
Notes prepayment percentage (in hundredths) 120.00%        
Notes repayment default amount $ 100,000        
Judgement stay period on note default 30 days        
Increase in interest rate (in hundredths) 18.00%        
Warrant to purchase shares of common stock (in shares) 194,118        
Warrants exercise price (in dollars per share) $ 0.85        
Warrants expiration date Apr. 30, 2020        
Maximum number of days with in which registration statement should be declared 120 days        
Number of days for registration effective for a period 180 days        
Unamortized Debt Discount $ 50,000        
Inter Mountain Capital Corp [Member] | Conversion Condition One [Member]          
Debt Instrument [Line Items]          
Average percentage of three lowest volume weighted average price (in hundredths) 80.00%        
Number of trading days in conversion 20 days        
Inter Mountain Capital Corp [Member] | Conversion Condition Two [Member]          
Debt Instrument [Line Items]          
Weighted average price of common stock (in dollars per share) $ 0.05        
Average percentage of three lowest volume weighted average price (in hundredths) 70.00%        
Number of trading days in conversion 20 days        
[1] As part of the April 2015 Note, at our option, subject to certain volume, price and other conditions, the monthly installments of principle and interest due under the April 2015 Note may be paid in whole, or in part, in cash or in Common Stock. If the monthly installments are paid in Common Stock, such shares being issued will be based on a price that is 80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days. The percentage declines to 70% if the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days is less than $0.05 per share.
XML 26 R29.htm IDEA: XBRL DOCUMENT v3.2.0.727
INVESTMENTS IN UNCONSOLIDATED ENTITIES (Tables)
6 Months Ended
Jun. 30, 2015
Altrazeal Trading Ltd. [Member]  
Schedule of Equity Method Investments [Line Items]  
Summarized financial information for investment
Summarized financial information for our investment in Altrazeal Trading Ltd. assuming 100% ownership is as follows:

Altrazeal Trading Ltd.
 
December 31, 2012
 
  Balance sheet
   
Total assets
 $136,661 
Total liabilities
 $660,006 
Total stockholders’ (deficit)
 $(523,345)
  Statement of operations
    
Revenues
 $61,028 
Net (loss)
 $(516,829)
Altrazeal Trading GmbH [Member]  
Schedule of Equity Method Investments [Line Items]  
Summarized financial information for investment
Summarized financial information for our investment in Altrazeal Trading assuming 100% ownership is as follows:

Altrazeal Trading GmbH
 
December 31, 2014
(Unaudited)
  
December 31, 2013
(Unaudited)
 
  Balance sheet
      
Total assets
 $1,039,343  $757,784 
Total liabilities
 $2,178,865  $1,563,046 
Total stockholders’ (deficit)
 $(1,139,522) $(805,262)
  Statement of operations
        
Revenues
 $882,583  $--- 
Net (loss)
 $(465,580) $(798,009)
ORADISC GmbH [Member]  
Schedule of Equity Method Investments [Line Items]  
Summarized financial information for investment
Summarized financial information for our investment in ORADISC GmbH assuming 100% ownership is as follows:

ORADISC GmbH
 
December 31, 2013
(Unaudited)
 
  Balance sheet
   
Total assets
 $305,069 
Total liabilities
 $302,572 
Total stockholders’ equity
 $2,497 
  Statement of operations
    
Revenues
 $--- 
Net (loss)
 $(34,671)
XML 27 R28.htm IDEA: XBRL DOCUMENT v3.2.0.727
INTANGIBLE ASSETS (Tables)
6 Months Ended
Jun. 30, 2015
INTANGIBLE ASSETS [Abstract]  
Intangible assets
Intangible assets are composed of patents acquired in October, 2005.  Intangible assets, net consisted of the following at June 30, 2015 and December 31, 2014:

Intangible assets
 
June 30, 2015
  
December 31, 2014
 
  Patent - Amlexanox (Aphthasol®)
 $2,090,000  $2,090,000 
  Patent - Amlexanox (OraDisc™ A)
  6,873,080   6,873,080 
  Patent - OraDisc™
  73,000   73,000 
  Patent - Hydrogel nanoparticle aggregate
  589,858   589,858 
    9,625,938   9,625,938 
  Less: accumulated amortization
  ( 6,665,871)  (6,430,249)
  Intangible assets, net
 $2,960,067  $3,195,689 
Future aggregate amortization expense for intangible assets
The future aggregate amortization expense for intangible assets, remaining as of June 30, 2015, is as follows:
Calendar Years
 
Future Amortization
Expense
 
  2015 (Six months)
 $239,526 
  2016
  476,450 
  2017
  475,148 
  2018
  475,148 
  2019
  475,148 
  2020 & Beyond
  818,647 
  Total
 $2,960,067 
XML 28 R44.htm IDEA: XBRL DOCUMENT v3.2.0.727
STOCKHOLDERS' EQUITY (Details)
6 Months Ended
Jun. 30, 2015
$ / shares
shares
Jun. 30, 2015
shares
Dec. 31, 2014
shares
Common Stock [Abstract]      
Common Stock, shares issued (in shares)   24,819,534 24,458,018
Common Stock, shares outstanding (in shares)   24,819,534 24,458,018
Common stock issued during period (in shares) 361,516    
Warrants and Number of Shares of Common Stock Subject to Exercise [Roll Forward]      
Balance (in shares) 1,676,401    
Warrants issued (in shares) 194,118    
Warrants exercised (in shares) (392,857)    
Warrants cancelled (in shares) (357,155)    
Balance (in shares) 1,120,507    
Warrants, Weighted-Average Exercise Price [Abstract]      
Balance (in dollars per share) | $ / shares 1.14    
Warrants issued (in dollars per share) | $ / shares 0.85    
Warrants exercised (in dollars per share) | $ / shares 0.35    
Warrants cancelled (in dollars per share) | $ / shares 2.85    
Balance (in dollars per share) | $ / shares 0.82    
Warrant shares subject to expiration [Abstract]      
Number of Warrant Shares of Common Stock Subject to Expiration (in shares) 1,676,401 1,120,507 1,676,401
Warrants expiration date Apr. 30, 2020    
June 13, 2016 [Member]      
Warrants and Number of Shares of Common Stock Subject to Exercise [Roll Forward]      
Balance (in shares) 35,000    
Warrant shares subject to expiration [Abstract]      
Number of Warrant Shares of Common Stock Subject to Expiration (in shares) 35,000 35,000  
July 16, 2016 [Member]      
Warrants and Number of Shares of Common Stock Subject to Exercise [Roll Forward]      
Balance (in shares) 116,667    
Warrant shares subject to expiration [Abstract]      
Number of Warrant Shares of Common Stock Subject to Expiration (in shares) 116,667 116,667  
July 28, 2016 [Member]      
Warrants and Number of Shares of Common Stock Subject to Exercise [Roll Forward]      
Balance (in shares) 34,722    
Warrant shares subject to expiration [Abstract]      
Number of Warrant Shares of Common Stock Subject to Expiration (in shares) 34,722 34,722  
March 14, 2018 [Member]      
Warrants and Number of Shares of Common Stock Subject to Exercise [Roll Forward]      
Balance (in shares) 660,000    
Warrant shares subject to expiration [Abstract]      
Number of Warrant Shares of Common Stock Subject to Expiration (in shares) 660,000 660,000  
January 15, 2019 [Member]      
Warrants and Number of Shares of Common Stock Subject to Exercise [Roll Forward]      
Balance (in shares) 80,000    
Warrant shares subject to expiration [Abstract]      
Number of Warrant Shares of Common Stock Subject to Expiration (in shares) 80,000 80,000  
April 30, 2020 [Member]      
Warrants and Number of Shares of Common Stock Subject to Exercise [Roll Forward]      
Balance (in shares) 194,118    
Warrant shares subject to expiration [Abstract]      
Number of Warrant Shares of Common Stock Subject to Expiration (in shares) 194,118 194,118  
Series A Preferred Stock [Member]      
Preferred Stock [Abstract]      
Preferred stock, shares issued (in shares)   0  
Preferred stock, shares outstanding (in shares)   0  
XML 29 R30.htm IDEA: XBRL DOCUMENT v3.2.0.727
ACCRUED LIABILITIES (Tables)
6 Months Ended
Jun. 30, 2015
ACCRUED LIABILITIES [Abstract]  
Accrued liabilities
Accrued liabilities consisted of the following at June 30, 2015 and December 31, 2014:

Accrued Liabilities
 
June 30, 2015
  
December 31, 2014
 
  Accrued taxes – payroll
 $106,299  $106,299 
  Accrued compensation/benefits
  208,678   96,795 
  Accrued insurance payable
  6,616   69,815 
  Accrued property taxes
  5,400   --- 
  Product rebates/returns
  8   13 
  Other
  ---   279 
  Total accrued liabilities
 $327,001  $273,201 
XML 30 R31.htm IDEA: XBRL DOCUMENT v3.2.0.727
PROMISSORY NOTE PAYABLE (Tables)
6 Months Ended
Jun. 30, 2015
PROMISSORY NOTE PAYABLE [Abstract]  
Promissory Notes Payable
Information relating to our promissory note payable is as follows:

             
As of June 30, 2015
    
Transaction
 
Initial Principal Amount
  
Interest
Rate
 
Maturity
Date
Conversion Price (1)
 
Principal
Balance
  
Unamortized Debt
Discount
  
Unamortized Debt Issuance Costs
  
Carrying
Value
 
  April 2015 Note
 $550,000   10.0%
08/12/2016
   $550,000  $58,100  $41,897  $450,003 
  Total
 $550,000          $550,000  $58,100  $41,897  $450,003 

  (1)
As part of the April 2015 Note, at our option, subject to certain volume, price and other conditions, the monthly installments of principle and interest due under the April 2015 Note may be paid in whole, or in part, in cash or in Common Stock.  If the monthly installments are paid in Common Stock, such shares being issued will be based on a price that is 80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days.  The percentage declines to 70% if the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days is less than $0.05 per share.
Future Minimum Payments of Promissory Note
The future minimum payments relating to our promissory note payable, as of June 30, 2015, are as follows:

   
Payments Due By Period
 
Transaction
 
Total
  
2014 (Six Months)
  
2015
  
2016
  
2017
  
2018
 
  April 2015 Note
 $550,000  $225,000  $325,000  $---  $---  $--- 
  Total
 $550,000  $225,000  $325,000  $---  $---  $--- 
XML 31 R8.htm IDEA: XBRL DOCUMENT v3.2.0.727
THE EFFECT OF RECENTLY ISSUED ACCOUNTING STANDARDS
6 Months Ended
Jun. 30, 2015
THE EFFECT OF RECENTLY ISSUED ACCOUNTING STANDARDS [Abstract]  
THE EFFECT OF RECENTLY ISSUED ACCOUNTING STANDARDS
NOTE 3.
THE EFFECT OF RECENTLY ISSUED ACCOUNTING STANDARDS

In April 2015, the Financial Accounting Standards Board issued Update No. 2015-03, Simplifying the Presentation of Debt Issuance Costs, which requires debt issuance costs related to a recognized debt liability to be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. The guidance is effective January 1, 2016 with early adoption permitted.  The Company has elected early adoption as the guidance is a change in financial statement presentation only and will not have a material impact in the consolidated financial results.

There were no other new accounting pronouncements adopted or enacted during the periods presented that had, or are expected to have, a material impact on our financial statements.
XML 32 R32.htm IDEA: XBRL DOCUMENT v3.2.0.727
STOCKHOLDERS' EQUITY (Tables)
6 Months Ended
Jun. 30, 2015
STOCKHOLDERS' EQUITY [Abstract]  
Warrants outstanding and number of shares of common stock subject to exercise
The following table summarizes the warrants outstanding and the number of shares of Common Stock subject to exercise as of June 30, 2015 and the changes therein during the six months then ended:

   
Number of Shares of Common Stock Subject to Exercise
  
Weighted – Average
Exercise Price
 
Balance as of December 31, 2014
  1,676,401  $1.14 
Warrants issued
  194,118  $0.85 
Warrants exercised
  (392,857) $0.35 
Warrants cancelled
  (357,155) $2.85 
Balance as of June 30, 2015
  1,120,507  $0.82 
Expiration dates for warrants subject to exercise
Of the warrant shares subject to exercise as of June 30, 2015, expiration of the right to exercise is as follows:
Date of Expiration
 
Number of Warrant Shares of Common Stock Subject to Expiration
 
  June 13, 2016
  35,000 
  July 16, 2016
  116,667 
  July 28, 2016
  34,722 
  March 14, 2018
  660,000 
  January 15, 2019
  80,000 
  April 30, 2020
  194,118 
  Total
  1,120,507 
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INTANGIBLE ASSETS (Details) - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2015
Jun. 30, 2014
Jun. 30, 2015
Jun. 30, 2014
Dec. 31, 2014
Finite-Lived Intangible Assets [Line Items]          
Intangible assets, gross $ 9,625,938   $ 9,625,938   $ 9,625,938
Less: accumulated amortization (6,665,871)   (6,665,871)   (6,430,249)
Intangible assets, net 2,960,067   2,960,067   3,195,689
Amortization expense 118,461 $ 118,461 235,622 $ 235,622  
Future aggregate amortization expense for intangible assets [Abstract]          
2015 (Six months) 239,526   239,526    
2016 476,450   476,450    
2017 475,148   475,148    
2018 475,148   475,148    
2019 475,148   475,148    
2020 & Beyond 818,647   818,647    
Total 2,960,067   2,960,067    
Patents [Member] | Amlexanox (Aphthasol) [Member]          
Finite-Lived Intangible Assets [Line Items]          
Intangible assets, gross 2,090,000   2,090,000   2,090,000
Patents [Member] | Amlexanox (OraDiscA) [Member]          
Finite-Lived Intangible Assets [Line Items]          
Intangible assets, gross 6,873,080   6,873,080   6,873,080
Patents [Member] | ORADISC [Member]          
Finite-Lived Intangible Assets [Line Items]          
Intangible assets, gross 73,000   73,000   73,000
Patents [Member] | Hydrogel Nanoparticle Aggregate [Member]          
Finite-Lived Intangible Assets [Line Items]          
Intangible assets, gross $ 589,858   $ 589,858   $ 589,858

XML 35 R2.htm IDEA: XBRL DOCUMENT v3.2.0.727
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($)
Jun. 30, 2015
Dec. 31, 2014
Current Assets    
Cash and cash equivalents $ 19,296 $ 550,458
Accounts receivable, net 2,381 3,879
Accounts receivable - related party, net 1,249,683 798,147
Inventory 538,187 325,657
Prepaid expenses and deferred charges 60,713 137,858
Total Current Assets 1,870,260 1,815,999
Property, Equipment and Leasehold Improvements, net 328,370 432,110
Other Assets    
Intangible assets, net 2,960,067 3,195,689
Investment in unconsolidated subsidiary 0 0
Deposits 18,069 18,069
Total Other Assets 2,978,136 3,213,758
TOTAL ASSETS 5,176,766 5,461,867
Current Liabilities    
Accounts payable 1,986,356 1,536,612
Accrued liabilities 327,001 273,201
Accrued interest 11,764 0
Promissory notes payable, net of unamortized debt discount and debt issuance costs, current portion 405,275 0
Deferred revenue, current portion 64,100 58,959
Total Current Liabilities 2,794,496 1,868,772
Long Term Liabilities    
Promissory notes payable, net of unamortized debt discount, debt issuance costs, and current portion 44,728 0
Deferred revenue, net of current portion 841,435 839,174
Total Long Term Liabilities 886,163 839,174
TOTAL LIABILITIES $ 3,680,659 $ 2,707,946
COMMITMENTS AND CONTINGENCIES    
STOCKHOLDERS' EQUITY    
Preferred stock - $0.001 par value; 20,000 shares authorized; Preferred Stock Series A, 1,000 shares designated; no shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively $ 0 $ 0
Common Stock - $0.001 par value; 200,000,000 shares authorized; 24,819,534 and 24,458,018 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively 24,820 24,458
Additional paid-in capital 56,499,358 56,289,882
Accumulated (deficit) (55,028,071) (53,560,419)
TOTAL STOCKHOLDERS' EQUITY 1,496,107 2,753,921
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 5,176,766 $ 5,461,867
XML 36 R45.htm IDEA: XBRL DOCUMENT v3.2.0.727
EARNINGS PER SHARE (Details) - $ / shares
6 Months Ended 12 Months Ended
Jun. 30, 2015
Dec. 31, 2014
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Antidilutive securities excluded from calculating basic and diluted net loss per common share (in shares) 3,974,130 3,376,308
Conversion price per share (in dollars per share) [1] $ 0  
Warrants to purchase common stock [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Antidilutive securities excluded from calculating basic and diluted net loss per common share (in shares) 1,120,507 1,676,401
Stock options to purchase common stock [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Antidilutive securities excluded from calculating basic and diluted net loss per common share (in shares) 1,664,573 1,699,907
Common stock issuable upon the assumed conversion of payments due under our promissory note from April 2015 [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Antidilutive securities excluded from calculating basic and diluted net loss per common share (in shares) [2] 1,189,050 0
Percentage of weighted average prices of shares of common stock (in hundredths) 80.00%  
Monthly installment payment terms If the monthly installments are paid in Common Stock, such shares being issued will be based on a price that is 80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days. The percentage declines to 70% if the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days is less than $0.05 per share.  
Preceding number of trading days to calculate weighted average common stock price 20 days  
Declined percentage of weighted average prices of shares of common stock (in hundredths) 70.00%  
Weighted average price of shares of common stock, Maximum (in dollars per share) $ 0.05  
Conversion price per share (in dollars per share) $ 0.50  
[1] As part of the April 2015 Note, at our option, subject to certain volume, price and other conditions, the monthly installments of principle and interest due under the April 2015 Note may be paid in whole, or in part, in cash or in Common Stock. If the monthly installments are paid in Common Stock, such shares being issued will be based on a price that is 80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days. The percentage declines to 70% if the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days is less than $0.05 per share.
[2] As part of the April 2015 Note, at our option, subject to certain volume, price and other conditions, the monthly installments of principle and interest due under the April 2015 Note may be paid in whole, or in part, in cash or in Common Stock. If the monthly installments are paid in Common Stock, such shares being issued will be based on a price that is 80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days. The percentage declines to 70% if the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days is less than $0.05 per share. For the purposes of this Table, we have assumed that all outstanding monthly installments of principal and interest will be paid in Common Stock based on a price of $0.50 per share (80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days prior to June 30, 2015).
XML 37 R6.htm IDEA: XBRL DOCUMENT v3.2.0.727
COMPANY OVERVIEW AND BASIS OF PRESENTATION
6 Months Ended
Jun. 30, 2015
COMPANY OVERVIEW AND BASIS OF PRESENTATION [Abstract]  
COMPANY OVERVIEW AND BASIS OF PRESENTATION
NOTE 1.
COMPANY OVERVIEW AND BASIS OF PRESENTATION

Company Overview

ULURU Inc. (hereinafter “we”, “our”, “us”, “ULURU”, or the “Company”) is a Nevada corporation.  We are a diversified specialty pharmaceutical company committed to developing and commercializing a broad range of innovative wound care and muco-adhesive film products based on our patented Nanoflex® and OraDiscTM technologies, with the goal of improving outcomes for patients, health care professionals, and health care payers.

Basis of Presentation

In the opinion of management, the accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and include the accounts of ULURU Inc., a Nevada corporation, and its wholly-owned subsidiary, Uluru Delaware Inc., a Delaware corporation.  They do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation of the Company’s financial position as of June 30, 2015 and the results of its operations for the three and six months ended June 30, 2015 and 2014 and cash flows for the six months ended June 30, 2015 and 2014 have been made.

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, as well as disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods.  Actual results may differ from those estimates and assumptions.  These differences are usually minor and are included in our consolidated financial statements as soon as they are known.  Our estimates, judgments, and assumptions are continually evaluated based on available information and experience. Because of the use of estimates inherent in the financial reporting process, actual results could differ from those estimates.

All intercompany transactions and balances have been eliminated in consolidation.

Operating results for the three and six months ended June 30, 2015 are not necessarily indicative of the results that may be expected for the year ending December 31, 2015.

These condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014, as filed with the Securities and Exchange Commission on April 1, 2015, including the risk factors set forth therein.

Liquidity and Going Concern

The report of our independent registered public accounting firm for the fiscal year ended December 31, 2014, contained an explanatory paragraph to reflect its significant doubt about our ability to continue as a going concern as a result of our history of losses and our liquidity position, as discussed herein and in this Form 10-Q.  Based on our existing liquidity, the expected level of operating expenses, projected sales of our existing products combined with other revenues and financing transactions we are exploring, we believe that we do not have sufficient working capital to meet our working capital and capital expenditure requirements through the third quarter of 2015.  In the long run we cannot be sure that our anticipated revenue growth will be realized or that we will generate significant positive cash flow from operations.  Moreover, we may not be able to raise sufficient additional capital on acceptable returns, or at all, to continue operations and may not be able to execute any strategic transactions.  Therefore, we are unable to assert that our financial position is sufficient to fund operations beyond the third quarter of 2015, and as a result, there is substantial doubt about our ability to continue as a going concern beyond the third quarter of 2015.
XML 38 R35.htm IDEA: XBRL DOCUMENT v3.2.0.727
FAIR VALUE MEASUREMENTS (Tables)
6 Months Ended
Jun. 30, 2015
FAIR VALUE MEASUREMENTS [Abstract]  
Fair value of our financial instruments
The following table summarizes the fair value of our financial instruments at June 30, 2015 and December 31, 2014.

Description
 
June 30, 2015
  
December 31, 2014
 
  Liabilities:
      
Promissory note – April 2015
 $550,000   --- 
XML 39 R22.htm IDEA: XBRL DOCUMENT v3.2.0.727
LEGAL PROCEEDINGS
6 Months Ended
Jun. 30, 2015
LEGAL PROCEEDINGS [Abstract]  
LEGAL PROCEEDINGS
NOTE 17.
LEGAL PROCEEDINGS

On or about August 22, 2014, Inter-Mountain Capital Corp. (“Inter-Mountain”) filed a Complaint against ULURU in the U.S. Federal Court for the District of Utah, Central Division.  The Complaint relates to Inter-Mountain’s delivery of a notice of a cashless exercise with respect to its last remaining warrant to purchase Common Stock on or about May 1, 2014 purporting to exercise it with respect to the delivery of 782,284 shares of Common Stock under the non-standard cashless exercise or conversion provisions in the warrant.  The Company declined to honor the exercise on the basis that, as a result of an amendment to the warrant agreed to in December 2013, the warrant was exercisable, on a cashless basis, with respect to only 261,516 shares of Common Stock as of May 1, 2014.  Inter-Mountain alleged that the Company’s refusal to honor the exercise constituted a breach of the warrant, breach of implied covenant of good faith and fair dealing, unjust enrichment, a violation of securities laws and common law fraud and sought actual damages, consequential damages, treble damages, specific performance, attorneys’ fees and costs and other relief.  Answers and counterclaims were filed.

On April 15, 2015, the Company and Inter-Mountain entered into a Settlement Agreement (the “Settlement Agreement”) for the purpose of settling the pending litigation between the Company and Inter-Mountain.  Under the Settlement Agreement and related documents, the Company and Inter-Mountain agreed that Inter-Mountain would exercise the warrant and receive 361,516 shares of Common Stock.  The Settlement Agreement also included standard releases and anticipated the prompt filing of dismissal documents.  As part of the settlement, the Company and Inter-Mountain signed and closed under the Securities Purchase Agreement described in Note 10.
 
From time to time, we may be involved in litigation relating to claims arising out of our operations in the normal course of business. We are not currently a party to any legal proceedings, the adverse outcome of which, in management’s opinion, individually or in the aggregate, would have a material adverse effect on the results of our operations or financial position. There are no material proceedings to which any director, officer or any of our affiliates, any owner of record or beneficially of more than five percent of any class of our voting securities, or any associate of any such director, officer, our affiliates, or security holder, is a party adverse to us or our consolidated subsidiary or has a material interest adverse thereto.
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COMMITMENTS AND CONTINGENCIES (Tables)
6 Months Ended
Jun. 30, 2015
COMMITMENTS AND CONTINGENCIES [Abstract]  
Future minimum lease payments
The future minimum lease payments under the 2015 office lease and the 2015 equipment lease are as follows as of June 30, 2015:

Calendar Years
 
Future Lease Expense
 
  2015 (Six months)
 $59,920 
  2016
  119,840 
  2017
  119,840 
  2018
  28,858 
  2019
  --- 
  Total
 $328,458 
Summary of compensation earned, compensation paid in cash, and compensation temporarily deferred
As of June 30, 2015, the following table summarizes the compensation temporarily deferred and subsequent repayments:

Name
 
2015
  
2014
  
2013
  
2012
  
2011
  
Total
 
  Kerry P. Gray (1) (2) (3)
 $151,806  $(119,986) $(91,000) $220,673  $140,313  $301,806 
  Terrance K. Wallberg
  14,966   (25,000)  (35,769)  24,230   36,539   14,996 
  Total
 $166,772  $(144,986) $(126,769) $244,903  $176,852  $316,772 

 
(1)
During 2015, Mr. Gray temporarily deferred compensation of $151,806 which consisted of $46,806 earned as salary compensation for his duties as President of the Company and $105,000 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors.
 
(2)
During 2014, Mr. Gray temporarily deferred compensation of $150,000 which consisted of $62,500 earned as salary compensation for his duties as President of the Company and $87,500 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors.  During 2014, Mr. Gray was also repaid $269,986 of temporarily deferred compensation, of which $100,000 was used by Mr. Gray for funding required pursuant to the March 2013 Offering.
 
(3)
During 2013, Mr. Gray temporarily deferred compensation of $221,500 which consisted of $11,500 earned pursuant to a Separation Agreement and $210,000 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors.  During 2013, Mr. Gray was also repaid $312,500 of temporarily deferred compensation, of which $300,000 was used by Mr. Gray for funding required pursuant to the March 2013 Offering.
XML 41 R24.htm IDEA: XBRL DOCUMENT v3.2.0.727
COMPANY OVERVIEW AND BASIS OF PRESENTATION (Policies)
6 Months Ended
Jun. 30, 2015
COMPANY OVERVIEW AND BASIS OF PRESENTATION [Abstract]  
Basis of Presentation
Basis of Presentation

In the opinion of management, the accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and include the accounts of ULURU Inc., a Nevada corporation, and its wholly-owned subsidiary, Uluru Delaware Inc., a Delaware corporation.  They do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation of the Company’s financial position as of June 30, 2015 and the results of its operations for the three and six months ended June 30, 2015 and 2014 and cash flows for the six months ended June 30, 2015 and 2014 have been made.

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, as well as disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods.  Actual results may differ from those estimates and assumptions.  These differences are usually minor and are included in our consolidated financial statements as soon as they are known.  Our estimates, judgments, and assumptions are continually evaluated based on available information and experience. Because of the use of estimates inherent in the financial reporting process, actual results could differ from those estimates.

All intercompany transactions and balances have been eliminated in consolidation.

Operating results for the three and six months ended June 30, 2015 are not necessarily indicative of the results that may be expected for the year ending December 31, 2015.

These condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014, as filed with the Securities and Exchange Commission on April 1, 2015, including the risk factors set forth therein.
Liquidity and Going Concern
Liquidity and Going Concern

The report of our independent registered public accounting firm for the fiscal year ended December 31, 2014, contained an explanatory paragraph to reflect its significant doubt about our ability to continue as a going concern as a result of our history of losses and our liquidity position, as discussed herein and in this Form 10-Q.  Based on our existing liquidity, the expected level of operating expenses, projected sales of our existing products combined with other revenues and financing transactions we are exploring, we believe that we do not have sufficient working capital to meet our working capital and capital expenditure requirements through the third quarter of 2015.  In the long run we cannot be sure that our anticipated revenue growth will be realized or that we will generate significant positive cash flow from operations.  Moreover, we may not be able to raise sufficient additional capital on acceptable returns, or at all, to continue operations and may not be able to execute any strategic transactions.  Therefore, we are unable to assert that our financial position is sufficient to fund operations beyond the third quarter of 2015, and as a result, there is substantial doubt about our ability to continue as a going concern beyond the third quarter of 2015.
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SIGNIFICANT ACCOUNTING POLICIES
6 Months Ended
Jun. 30, 2015
SIGNIFICANT ACCOUNTING POLICIES [Abstract]  
SIGNIFICANT ACCOUNTING POLICIES
NOTE 2.
SIGNIFICANT ACCOUNTING POLICIES

The significant accounting policies used in preparation of these condensed consolidated financial statements for the three and six months ended June 30, 2015 are consistent with those discussed in Note 2 to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2014, as filed with the Securities and Exchange Commission on April 1, 2015.
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CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares
Jun. 30, 2015
Dec. 31, 2014
STOCKHOLDERS' EQUITY    
Preferred stock, par value (in dollars per share) $ 0.001 $ 0.001
Preferred stock, shares authorized (in shares) 20,000 20,000
Common Stock, par value (in dollars per share) $ 0.001 $ 0.001
Common Stock, shares authorized (in shares) 200,000,000 200,000,000
Common Stock, shares issued (in shares) 24,819,534 24,458,018
Common Stock, shares outstanding (in shares) 24,819,534 24,458,018
Series A Preferred Stock [Member]    
STOCKHOLDERS' EQUITY    
Shares designated to Series A (in shares) 1,000 1,000
Preferred stock, shares issued (in shares) 0 0
Preferred stock, shares outstanding (in shares) 0 0
XML 45 R17.htm IDEA: XBRL DOCUMENT v3.2.0.727
EARNINGS PER SHARE
6 Months Ended
Jun. 30, 2015
EARNINGS PER SHARE [Abstract]  
EARNINGS PER SHARE
NOTE 12.
EARNINGS PER SHARE

Basic and Diluted Net Loss Per Share

In accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 260, Earnings per Share, basic earnings (loss) per common share is computed by dividing net income (loss) by the weighted average number of common shares outstanding for the period.  Diluted earnings (loss) per common share is computed by dividing net income (loss) by the weighted average number of common shares outstanding during the period, increased to include potential dilutive common shares.  The effect of outstanding stock options, restricted vesting Common Stock, convertible debt, convertible preferred stock, and warrants, when dilutive, is reflected in diluted earnings (loss) per common share by application of the treasury stock method.  We have excluded all outstanding stock options, restricted vesting Common Stock, convertible debt, convertible preferred stock, and warrants from the calculation of diluted net loss per common share because all such securities are antidilutive for all periods presented.

Shares used in calculating basic and diluted net loss per common share exclude these potential common shares as of June 30, 2015 and December 31, 2014:


   
June 30, 2015
  
December 31, 2014
 
Warrants to purchase Common Stock
  1,120,507   1,676,401 
Stock options to purchase common stock
  1,664,573   1,699,907 
Common stock issuable upon the assumed conversion of payments due under our promissory note from April 2015 (1)
  1,189,050   --- 
  Total
  3,974,130   3,376,308 

(1)
As part of the April 2015 Note, at our option, subject to certain volume, price and other conditions, the monthly installments of principle and interest due under the April 2015 Note may be paid in whole, or in part, in cash or in Common Stock.  If the monthly installments are paid in Common Stock, such shares being issued will be based on a price that is 80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days.  The percentage declines to 70% if the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days is less than $0.05 per share.  For the purposes of this Table, we have assumed that all outstanding monthly installments of principal and interest will be paid in Common Stock based on a price of $0.50 per share (80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days prior to June 30, 2015).
XML 46 R1.htm IDEA: XBRL DOCUMENT v3.2.0.727
Document and Entity Information - shares
6 Months Ended
Jun. 30, 2015
Aug. 14, 2015
Entity Information [Line Items]    
Entity Registrant Name ULURU Inc.  
Entity Central Index Key 0001168220  
Current Fiscal Year End Date --12-31  
Entity Well-known Seasoned Issuer No  
Entity Voluntary Filers No  
Entity Current Reporting Status Yes  
Entity Filer Category Smaller Reporting Company  
Document Fiscal Year Focus 2015  
Document Fiscal Period Focus Q2  
Document Type 10-Q  
Amendment Flag false  
Document Period End Date Jun. 30, 2015  
Common Stock [Member]    
Entity Information [Line Items]    
Entity Common Stock, Shares Outstanding   24,819,534
Series A Preferred Stock [Member]    
Entity Information [Line Items]    
Entity Common Stock, Shares Outstanding   0
XML 47 R18.htm IDEA: XBRL DOCUMENT v3.2.0.727
SHARE BASED COMPENSATION
6 Months Ended
Jun. 30, 2015
SHARE BASED COMPENSATION [Abstract]  
SHARE BASED COMPENSATION
NOTE 13.
SHARE BASED COMPENSATION

The Company’s share-based compensation plan, the 2006 Equity Incentive Plan, as amended (“Equity Incentive Plan”), is administered by the compensation committee of the Board of Directors (“Board”), which selects persons to receive awards and determines the number of shares subject to each award and the terms, conditions, performance measures and other provisions of the award.

Our Board granted the following incentive stock option awards to executives or employees and nonstatutory stock option awards to directors or non-employees for the three and six months ended June 30:

   
Three Months Ended
June 30,
  
Six Months Ended
 June 30,
 
   
2015
  
2014
  
2015
  
2014
 
Incentive Stock Options  (1)
            
Quantity
  ---   ---   ---   --- 
Weighted average fair value per share
  ---   ---   ---   --- 
Fair value
  ---   ---   ---   --- 
                  
Nonstatutory Stock Options  (2)
                
Quantity
  ---   ---   ---   --- 
Weighted average fair value per share
  ---   ---   ---   --- 
Fair value
  ---   ---   ---   --- 

 
(1)
The Company did not award any incentive stock options for the three and six months ended June 30, 2015 and 2014, respectively.
 
(2)
The Company did not award any nonstatutory stock options for the three and six months ended June 30, 2015 and 2014, respectively.

We account for share-based compensation under FASB ASC Topic 718, Stock Compensation, which requires the measurement and recognition of compensation expense for all share-based payment awards made to employees, consultants, and directors based on estimated fair values of the award on the grant date.  We use the Black-Scholes option-pricing model to estimate the fair value of share-based awards.
 
Stock Options (Incentive and Nonstatutory)

The following table summarizes share-based compensation related to stock options for the three and six months ended June 30:

   
Three Months Ended
 June 30,
  
Six Months Ended
 June 30,
 
   
2015
  
2014
  
2015
  
2014
 
Research and development
 $18,819  $5,365  $37,431  $10,672 
Selling, general and administrative
  51,019   17,018   107,755   36,251 
  Total share-based compensation expense
 $69,838  $22,383  $145,186  $46,923 

At June 30, 2015, the balance of unearned share-based compensation to be expensed in future periods related to unvested stock option awards, as adjusted for expected forfeitures, is approximately $408,000.  The period over which the unearned share-based compensation is expected to be recognized is approximately twenty seven months.

The following table summarizes the stock options outstanding and the number of shares of Common Stock subject to exercise as of June 30, 2015 and the changes therein during the six months then ended:

   
Stock Options
  
Weighted Average Exercise Price per Share
 
Outstanding as of December 31, 2014
  1,699,907  $1.73 
Granted
  ---   --- 
Forfeited/cancelled
  (35,334) $1.77 
Exercised
  ---   --- 
Outstanding as of June 30, 2015
  1,664,573  $1.73 
 
The following table presents the stock option grants outstanding and exercisable as of June 30, 2015:

Options Outstanding
  
Options Exercisable
 
Stock Options Outstanding
  
Weighted Average Exercise Price per Share
  
Weighted Average Remaining Contractual Life in Years
  
Stock Options Exercisable
  
Weighted Average Exercise Price per Share
 
 882,500  $0.33   7.7   640,000  $0.33 
 680,000   1.15   7.4   77,500   1.15 
 33,334   2.55   4.8   33,334   2.55 
 68,739   25.07   2.1   68,739   25.07 
 1,664,573  $1.73   7.3   819,573  $2.57 

Restricted Stock Awards

Restricted stock awards, which typically vest over a period of two to five years, are issued to certain key employees and are subject to forfeiture until the end of an established restriction period.  We utilize the market price on the date of grant as the fair market value of restricted stock awards and expense the fair value on a straight-line basis over the vesting period.

For the three and six months ended June 30, 2015 and 2014, we did not grant any restricted stock awards.

At June 30, 2015, the balance of unearned share-based compensation to be expensed in future periods related to restricted stock awards, as adjusted for expected forfeitures, is zero.
 
Summary of Plans

2006 Equity Incentive Plan

In March 2006, our Board adopted and our stockholders approved our Equity Incentive Plan, which initially provided for the issuance of up to 133,333 shares of our Common Stock pursuant to stock option and other equity awards.  At the annual meetings of the stockholders held on May 8, 2007, December 17, 2009, June 15, 2010, June 14, 2012, June 13, 2013, and on June 5, 2014, our stockholders approved amendments to the Equity Incentive Plan to increase the total number of shares of Common Stock issuable under the Equity Incentive Plan pursuant to stock options and other equity awards by 266,667 shares, 200,000 shares, 200,000 shares, 400,000 shares, 600,000 shares, and 1,000,000 shares, respectively, to a total of 2,800,000 shares.

In December 2006, we began issuing stock options to employees, consultants, and directors.  The stock options issued generally vest over a period of one to four years and have a maximum contractual term of ten years.  In January 2007, we began issuing restricted stock awards to our employees.  Restricted stock awards generally vest over a period of six months to five years after the date of grant.  Prior to vesting, restricted stock awards do not have dividend equivalent rights, do not have voting rights and the shares underlying the restricted stock awards are not considered issued and outstanding.  Shares of Common Stock are issued on the date the restricted stock awards vest.

As of June 30, 2015, we had granted options to purchase 2,061,167 shares of Common Stock since the inception of the Equity Incentive Plan, of which 1,664,573 were outstanding at a weighted average exercise price of $1.73 per share, and we had granted awards for 68,616 shares of restricted stock since the inception of the Equity Incentive Plan, of which none were outstanding.  As of June 30, 2015, there were 1,065,981 shares that remained available for future grants under our Equity Incentive Plan.
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2015
Jun. 30, 2014
Jun. 30, 2015
Jun. 30, 2014
Revenues        
License fees $ 15,979 $ 14,698 $ 30,518 $ 29,237
Royalty income 0 17,012 0 17,012
Product sales, net 243,018 177,584 523,127 265,026
Total Revenues 258,997 209,294 553,645 311,275
Costs and Expenses        
Cost of product sold 81,286 113,090 182,816 154,132
Research and development 219,335 184,423 423,494 372,019
Selling, general and administrative 495,034 411,279 941,191 880,352
Amortization of intangible assets 118,461 118,461 235,622 235,622
Depreciation 46,218 59,553 104,527 120,107
Total Costs and Expenses 960,334 886,806 1,887,650 1,762,232
Operating (Loss) (701,337) (677,512) (1,334,005) (1,450,957)
Other Income (Expense)        
Interest and miscellaneous income 69 519 211 5,060
Interest (expense) income (63,185) (32,722) (76,154) 2,969
Equity in earnings (loss) of unconsolidated subsidiary 0 0 0 0
Foreign currency transaction gain (loss) 35,074 0 (57,704) 0
Loss on early extinguishment of convertible note 0 0 0 (135,078)
(Loss) Before Income Taxes (729,379) (709,715) (1,467,652) (1,578,006)
Income taxes 0 0 0 0
Net (Loss) $ (729,379) $ (709,715) $ (1,467,652) $ (1,578,006)
Basic and diluted net (loss) per common share (in dollars per share) $ (0.03) $ (0.03) $ (0.06) $ (0.07)
Weighted average number of common shares outstanding (in shares) 24,767,889 24,122,176 24,613,809 22,776,695
XML 49 R12.htm IDEA: XBRL DOCUMENT v3.2.0.727
INTANGIBLE ASSETS
6 Months Ended
Jun. 30, 2015
INTANGIBLE ASSETS [Abstract]  
INTANGIBLE ASSETS
NOTE 7.
INTANGIBLE ASSETS

Intangible assets are composed of patents acquired in October, 2005.  Intangible assets, net consisted of the following at June 30, 2015 and December 31, 2014:

Intangible assets
 
June 30, 2015
  
December 31, 2014
 
  Patent - Amlexanox (Aphthasol®)
 $2,090,000  $2,090,000 
  Patent - Amlexanox (OraDisc™ A)
  6,873,080   6,873,080 
  Patent - OraDisc™
  73,000   73,000 
  Patent - Hydrogel nanoparticle aggregate
  589,858   589,858 
    9,625,938   9,625,938 
  Less: accumulated amortization
  ( 6,665,871)  (6,430,249)
  Intangible assets, net
 $2,960,067  $3,195,689 

Amortization expense for intangible assets was $118,461 and $118,461 for the three months ended June 30, 2015 and 2014, respectively, and was $235,622 and $235,622 for the six months ended June 30, 2015 and 2014, respectively.

The future aggregate amortization expense for intangible assets, remaining as of June 30, 2015, is as follows:
Calendar Years
 
Future Amortization
Expense
 
  2015 (Six months)
 $239,526 
  2016
  476,450 
  2017
  475,148 
  2018
  475,148 
  2019
  475,148 
  2020 & Beyond
  818,647 
  Total
 $2,960,067 
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PROPERTY, EQUIPMENT and LEASEHOLD IMPROVEMENTS
6 Months Ended
Jun. 30, 2015
PROPERTY, EQUIPMENT and LEASEHOLD IMPROVEMENTS [Abstract]  
PROPERTY, EQUIPMENT and LEASEHOLD IMPROVEMENTS
NOTE 6.
PROPERTY, EQUIPMENT and LEASEHOLD IMPROVEMENTS

Property, equipment and leasehold improvements, net, consisted of the following at June 30, 2015 and December 31, 2014:

Property, equipment and leasehold improvements
 
June 30, 2015
  
December 31, 2014
 
  Laboratory equipment
 $424,888  $424,888 
  Manufacturing equipment
  1,599,894   1,599,894 
  Computers, office equipment, and furniture
  153,865   153,078 
  Computer software
  4,108   4,108 
  Leasehold improvements
  95,841   95,841 
    2,278,596   2,277,809 
  Less: accumulated depreciation and amortization
  (1,950,226)  (1,845,699)
  Property, equipment and leasehold improvements, net
 $328,370  $432,110 

Depreciation expense on property, equipment and leasehold improvements was $46,218 and $59,553 for the three months ended June 30, 2015 and 2014, respectively, and was $104,527 and $120,107 for the six months ended June 30, 2015 and 2014, respectively.
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SUBSEQUENT EVENTS
6 Months Ended
Jun. 30, 2015
SUBSEQUENT EVENTS [Abstract]  
SUBSEQUENT EVENTS
NOTE 18.
SUBSEQUENT EVENTS

None.
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FAIR VALUE MEASUREMENTS
6 Months Ended
Jun. 30, 2015
FAIR VALUE MEASUREMENTS [Abstract]  
FAIR VALUE MEASUREMENTS
NOTE 14.
FAIR VALUE MEASUREMENTS

In accordance with FASB ASC Topic 820, Fair Value Measurements, (“ASC Topic 820”) certain assets and liabilities of the Company are required to be recorded at fair value.  Fair value is determined based on the exchange price that would be received for an asset or paid to transfer a liability in an orderly transaction between market participants.  The guidance in ASC Topic 820 also establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimized the use of unobservable inputs by requiring that the most observable inputs be used when available.

Observable inputs are based on market data obtained from independent sources, while unobservable inputs are based on our market assumptions.  Unobservable inputs require significant management judgment or estimation.  In some cases, the inputs used to measure an asset or liability may fall into different levels of the fair value hierarchy.  In those instances, the fair value measurement is required to be classified using the lowest level of input that is significant to the fair value measurement.  Such determination requires significant management judgment.
 
The three-tier value hierarchy, which prioritizes the inputs used in the valuation methodologies, is as follows:

 
Level 1
Valuations based on quoted prices (unadjusted) for identical assets or liabilities in active markets.

 
Level 2
Valuations based on observable inputs other than quoted prices in Level 1, such as quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, and other inputs that are observable or can be corroborated by observable market data.

 
Level 3
Valuations based on unobservable inputs reflecting the Company’s own assumptions, consistent with reasonably available assumptions made by other market participants.

Assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurements.  We review the fair value hierarchy classification on a quarterly basis.  Changes in the observability of valuation inputs may result in a reclassification of levels for certain securities within the fair value hierarchy.

Our financial instruments, including cash, cash equivalents, accounts receivable, and accounts payable are carried at cost, which approximates their fair value because of the short-term maturity of these instruments.  We believe that the carrying value of our other receivable and convertible note payable balances approximates fair value based on a valuation methodology using the income approach and a discounted cash flow model.

The following table summarizes the fair value of our financial instruments at June 30, 2015 and December 31, 2014.

Description
 
June 30, 2015
  
December 31, 2014
 
  Liabilities:
      
Promissory note – April 2015
 $550,000   --- 
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PROMISSORY NOTE PAYABLE
6 Months Ended
Jun. 30, 2015
PROMISSORY NOTE PAYABLE [Abstract]  
PROMISSORY NOTE PAYABLE
NOTE 10.
PROMISSORY NOTE PAYABLE

Debt Financing – April 2015

On April 15, 2015, we entered into a Securities Purchase Agreement dated April 14, 2015 (the “Purchase Agreement”) with Inter-Mountain Capital Corp. (“Inter-Mountain”) related to our issuance of a $550,000 Promissory Note (the “April 2015 Note”).  The purchase price for the April 2015 Note, which reflects a $50,000 original issue discount, was $500,000. The Purchase Agreement also included representations and warranties, restrictive covenants and indemnification provisions standard for similar transactions.

The April 2015 Note bears interest at the rate of 10.0% per annum, with monthly installment payments of $45,000 commencing on the date that is 120 calendar days after the issuance date of the Note. At our option, subject to certain volume, price and other conditions, the monthly installments may be paid in whole, or in part, in cash or in Common Stock.  If the monthly installments are paid in Common Stock, such shares being issued will be based on a price that is 80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days.  The percentage declines to 70% if the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days is less than $0.05 per share.  The April 2015 Note is not subject to conversion at the discretion of Inter-Mountain.

At our option, the outstanding principal balance of the April 2015 Note, or a portion thereof, may be prepaid in cash at 120% of the amount elected to be prepaid.  The April 2015 Note is unsecured.

Events of default under the April 2015 Note include failure to make required payments, the entry of a $100,000 judgment not stayed within 30 days, breach of representations or covenants under the transaction documents, various events associated with insolvency or failure to pay debts, delisting of the Common Stock, a restatement of financial statements and a default under certain other agreements.  In the event of default, the interest rate under the April 2015 Note increases to 18% and the April 2015 Note becomes callable at a premium.  In addition, Inter-Mountain has all remedies under law and equity.

As part of the debt financing, Inter-Mountain also received a warrant (the “Warrant”) to purchase up to an aggregate of 194,118 shares of Common Stock.  The Warrant has an exercise price of $0.85 per share and expires on April 30, 2020. The Warrant includes a standard net cashless exercise provision and provisions requiring proportionate adjustments in connection with a recapitalization transaction.

As part of the debt financing, we entered into a Registration Rights Agreement whereby we agreed to prepare and file with the Securities and Exchange Commission (the “SEC”) a registration statement no later than May 11, 2015 and to cause such registration statement to be declared effective no later than 120 after the closing date and to keep such registration statement effective for a period of no less than 180 days.  In accordance with our obligations under the Registration Rights Agreement, we filed with the SEC a registration statement that was declared effective on June 4, 2015.
 
Using specific guidelines in accordance with U.S. GAAP, we allocated the value of the proceeds received to the promissory note and to the warrant on a relative fair value basis.  We calculated the fair value of the warrant issued with the debt instrument using the Black-Scholes valuation method, using the same assumptions used for valuing employee stock options, except the contractual life of the warrant was used. Using the effective interest method, the allocated fair value of the warrant was recorded as a debt discount and is being amortized over the expected term of the promissory note to interest expense.

Information relating to our promissory note payable is as follows:

             
As of June 30, 2015
    
Transaction
 
Initial Principal Amount
  
Interest
Rate
 
Maturity
Date
Conversion Price (1)
 
Principal
Balance
  
Unamortized Debt
Discount
  
Unamortized Debt Issuance Costs
  
Carrying
Value
 
  April 2015 Note
 $550,000   10.0%
08/12/2016
   $550,000  $58,100  $41,897  $450,003 
  Total
 $550,000          $550,000  $58,100  $41,897  $450,003 

  (1)
As part of the April 2015 Note, at our option, subject to certain volume, price and other conditions, the monthly installments of principle and interest due under the April 2015 Note may be paid in whole, or in part, in cash or in Common Stock.  If the monthly installments are paid in Common Stock, such shares being issued will be based on a price that is 80% of the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days.  The percentage declines to 70% if the average of the three lowest volume weighted average prices of the shares of Common Stock during the preceding twenty trading days is less than $0.05 per share.
 
The amount of interest cost recognized from our promissory note and convertible notes payable was $11,764 and $5,952 for the three months ended June 30, 2015 and 2014, respectively, and was $11,764 and $19,897 for the six months ended June 30, 2015 and 2014, respectively.

The amount of debt discount amortized from our promissory note and convertible notes payable was $11,035 and $2,655 for the three months ended June 30, 2015 and 2014, respectively, and was $11,035 and $(78,630) for the six months ended June 30, 2015 and 2014, respectively.

The future minimum payments relating to our promissory note payable, as of June 30, 2015, are as follows:

   
Payments Due By Period
 
Transaction
 
Total
  
2014 (Six Months)
  
2015
  
2016
  
2017
  
2018
 
  April 2015 Note
 $550,000  $225,000  $325,000  $---  $---  $--- 
  Total
 $550,000  $225,000  $325,000  $---  $---  $--- 
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INVESTMENTS IN UNCONSOLIDATED ENTITIES
6 Months Ended
Jun. 30, 2015
INVESTMENTS IN UNCONSOLIDATED ENTITIES [Abstract]  
INVESTMENTS IN UNCONSOLIDATED ENTITIES
NOTE 8.
INVESTMENTS IN UNCONSOLIDATED ENTITIES

We use the equity method of accounting for investments in other companies that are not controlled by us and in which our interest is generally between 20% and 50% of the voting shares or we have significant influence over the entity, or both.

Altrazeal Trading Ltd.

On January 11, 2012, we executed a shareholders’ agreement for the establishment of Altrazeal Trading Ltd., a single purpose entity to be used for the exclusive marketing of Altrazeal® throughout the European Union, Australia, New Zealand, North Africa, and the Middle East.  As a result of this transaction, we received a non-dilutable 25% ownership interest in Altrazeal Trading Ltd.  On February 1, 2014, Altrazeal Trading Ltd. transferred all of their rights and obligations under the existing shareholders’ agreement to Altrazeal Trading GmbH.

Audited financial statements of Altrazeal Trading Ltd. for the years ended December 31, 2013 and 2014 and unaudited financial statements for the three and six months ended June 30, 2015 have not been released to us and, therefore, we have not included the effect of the financial activities of Altrazeal Trading Ltd. in our financial statements for each reporting period.  We believe that our share of the cumulative losses of Altrazeal Trading Ltd. for the six months ended June 30, 2015 and for the years ended December 31, 2014, 2013, and 2012 would exceed the carrying value of our investment, therefore the equity method of accounting would be suspended for such reporting periods and no additional losses would be charged to operations.

Based upon audited financial statements received in May 2014, our unrecorded share of Altrazeal Trading Ltd. losses for the year ended December 31, 2012 totaled $129,207.

Summarized financial information for our investment in Altrazeal Trading Ltd. assuming 100% ownership is as follows:

Altrazeal Trading Ltd.
 
December 31, 2012
 
  Balance sheet
   
Total assets
 $136,661 
Total liabilities
 $660,006 
Total stockholders’ (deficit)
 $(523,345)
  Statement of operations
    
Revenues
 $61,028 
Net (loss)
 $(516,829)

Altrazeal Trading GmbH

On February 1, 2014, Altrazeal Trading Ltd. transferred all of their rights and obligations under the existing shareholders’ agreement to Altrazeal Trading GmbH (“Altrazeal Trading”).  As a result of this transfer, we received a non-dilutable 25% ownership interest in Altrazeal Trading.

Audited financial statements of Altrazeal Trading for the years ended December 31, 2013 and 2014 and unaudited financial statements for the three and six months ended June 30, 2015 have not been released to us and, therefore, we have not included the effect of the financial activities of Altrazeal Trading in our financial statements for each reporting period.  We believe that our share of the cumulative losses of Altrazeal Trading for the six months ended June 30, 2015 and for the years ended December 31, 2014 and 2013 would exceed the carrying value of our investment, therefore the equity method of accounting would be suspended for such reporting periods and no additional losses would be charged to operations.

Based upon the unaudited financial statements for the year ended December 31, 2014, our unrecorded share of Altrazeal Trading cumulative losses as of December 31, 2014 totaled $295,477.

Summarized financial information for our investment in Altrazeal Trading assuming 100% ownership is as follows:

Altrazeal Trading GmbH
 
December 31, 2014
(Unaudited)
  
December 31, 2013
(Unaudited)
 
  Balance sheet
      
Total assets
 $1,039,343  $757,784 
Total liabilities
 $2,178,865  $1,563,046 
Total stockholders’ (deficit)
 $(1,139,522) $(805,262)
  Statement of operations
        
Revenues
 $882,583  $--- 
Net (loss)
 $(465,580) $(798,009)
 
Purchase of Altrazeal Trading GmbH – May 2015

On May 12, 2015, we entered into a Binding Term Sheet (the “Term Sheet”) with IPMD GmbH, an Austrian limited liability company, and Firnron Ltd., a Cypriot limited liability company (collectively, the “Seller”) related to our purchase of 75% of the share capital of Altrazeal Trading.  We currently own the remaining 25% of share capital of Altrazeal Trading.  Altrazeal Trading is the distributor of Altrazeal® transforming powder dressing in European Union, Australia, New Zealand, Middle East (excluding Jordan and Syria), North Africa, Albania, Bosnia, Croatia, Kosovo, Macedonia, Montenegro, and Serbia.

Pursuant to the terms and conditions in the Term Sheet, the purchase price will be composed of 3,150,000 Euro for the purchase of the share capital of Altrazeal Trading and 88,834 Euro for the purchase of product inventory.  The purchase of the share capital of Altrazeal Trading will be paid in installments, with 1,147,200 Euro due at closing (of which 646,500 Euro will be paid with an offset of accounts receivable) and five installment payments of 500,700 Euro due by no later than June 30, 2015, August 31, 2015, October 31, 2015, and December 31, 2015.  The sale is structured as an “installment sale”, with 15% of equity in Altrazeal Trading being transferred upon the payment of each installment by us.  The installments are payable in either cash or in shares of our common stock at our option.  If installment payments are made in common stock, the calculation of shares to be issued will be 110% of the average closing price for the last 10 trading days prior to the installment payment date and include a warrant for 10% of the shares issued with a premium of $0.30 per share to the market price. The purchase of the product inventory for 88,834 Euro will be paid on September 30, 2015.
 
To the extent we issue shares of common stock to pay the purchase price, we have agreed to register the resale of such shares to the extent possible. The Term Sheet anticipates the negotiation and execution of a purchase agreement containing all terms of the Term Sheet and other standard terms for such a transaction within 60 days.  Such 60 day period expired on July 21, 2015 but both parties are continuing in their efforts to finalize the negotiation and execution of a purchase agreement by no later than November 15, 2015.
 
ORADISC GmbH

On October 19, 2012, we executed a shareholders’ agreement for the establishment of ORADISC GmbH, a single purpose entity to be used for the exclusive development and marketing of OraDisc™ erodible film technology products.  We received a non-dilutable 25% ownership interest in ORADISC GmbH.

Audited financial statements of ORADISC GmbH for the years ended December 31, 2013 and 2014 and unaudited financial statements for the three and six months ended June 30, 2015 have not been released to us and, therefore, we have not included the effect of the financial activities of ORADISC GmbH. in our financial statements for each reporting period.  We believe that our share of the cumulative losses of ORADISC GmbH for the six months ended June 30, 2015 and for the years ended December 31, 2014 and 2013 would exceed the carrying value of our investment, therefore the equity method of accounting would be suspended for such reporting periods and no additional losses would be charged to operations.

Based upon the unaudited financial statements for the year ended December 31, 2013, our unrecorded share of ORADISC GmbH cumulative losses as of December 31, 2013 totaled $11,430.

Summarized financial information for our investment in ORADISC GmbH assuming 100% ownership is as follows:

ORADISC GmbH
 
December 31, 2013
(Unaudited)
 
  Balance sheet
   
Total assets
 $305,069 
Total liabilities
 $302,572 
Total stockholders’ equity
 $2,497 
  Statement of operations
    
Revenues
 $--- 
Net (loss)
 $(34,671)
 
Altrazeal AG

On February 1, 2014, we executed a shareholders’ agreement with Altrazeal AG, a single purpose entity for the marketing of Altrazeal® in several territories, including Africa (markets not already licensed), Latin America, Georgia, Turkmenistan, Ukraine, the Commonwealth of Independent States, Jordan, Syria, Asia and the Pacific (excluding China, Hong Kong, Macau, Taiwan, South Korea, Japan, Australia, and New Zealand).  As a result of this transaction, we received a non-dilutable 25% ownership interest in Altrazeal AG.

Audited or unaudited financial statements of Altrazeal AG for the three and six months ended June 30, 2015 and for the year ended December 31, 2014 have not been released to us and, therefore, we have not included the effect of the financial activities of Altrazeal AG in our financial statements for such reporting period.  We believe that our share of the cumulative losses of Altrazeal AG for the six months ended June 30, 2015 and for the year ended December 31, 2014 would exceed the carrying value of our investment, therefore the equity method of accounting would be suspended for such reporting periods and no additional losses would be charged to operations.
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ACCRUED LIABILITIES
6 Months Ended
Jun. 30, 2015
ACCRUED LIABILITIES [Abstract]  
ACCRUED LIABILITIES
NOTE  9.
ACCRUED LIABILITIES

Accrued liabilities consisted of the following at June 30, 2015 and December 31, 2014:

Accrued Liabilities
 
June 30, 2015
  
December 31, 2014
 
  Accrued taxes – payroll
 $106,299  $106,299 
  Accrued compensation/benefits
  208,678   96,795 
  Accrued insurance payable
  6,616   69,815 
  Accrued property taxes
  5,400   --- 
  Product rebates/returns
  8   13 
  Other
  ---   279 
  Total accrued liabilities
 $327,001  $273,201 
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STOCKHOLDERS' EQUITY
6 Months Ended
Jun. 30, 2015
STOCKHOLDERS' EQUITY [Abstract]  
STOCKHOLDERS' EQUITY
NOTE 11.
STOCKHOLDERS’ EQUITY

Common Stock

As of June 30, 2015, we had 24,819,534 shares of Common Stock issued and outstanding.  For the three months ended June 30, 2015, we issued 361,516 shares of Common Stock issued for the cashless exercise of a warrant held by Inter-Mountain Capital Corp.

Preferred Stock

As of June 30, 2015, we had no shares of Series A Preferred Stock (the “Series A Shares”) issued and outstanding.  For the three months ended June 30, 2015, we did not issue or redeem any Series A Shares.

Warrants

The following table summarizes the warrants outstanding and the number of shares of Common Stock subject to exercise as of June 30, 2015 and the changes therein during the six months then ended:

   
Number of Shares of Common Stock Subject to Exercise
  
Weighted – Average
Exercise Price
 
Balance as of December 31, 2014
  1,676,401  $1.14 
Warrants issued
  194,118  $0.85 
Warrants exercised
  (392,857) $0.35 
Warrants cancelled
  (357,155) $2.85 
Balance as of June 30, 2015
  1,120,507  $0.82 

For the three months ended June 30, 2015, we issued a warrant to Inter-Mountain to purchase up to an aggregate of 194,118 shares of Common Stock.  The Warrant has an exercise price of $0.85 per share and expires on April 30, 2020.

Of the warrant shares subject to exercise as of June 30, 2015, expiration of the right to exercise is as follows:
Date of Expiration
 
Number of Warrant Shares of Common Stock Subject to Expiration
 
  June 13, 2016
  35,000 
  July 16, 2016
  116,667 
  July 28, 2016
  34,722 
  March 14, 2018
  660,000 
  January 15, 2019
  80,000 
  April 30, 2020
  194,118 
  Total
  1,120,507 
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SHARE BASED COMPENSATION (Tables)
6 Months Ended
Jun. 30, 2015
SHARE BASED COMPENSATION [Abstract]  
Stock option awards granted
Our Board granted the following incentive stock option awards to executives or employees and nonstatutory stock option awards to directors or non-employees for the three and six months ended June 30:

   
Three Months Ended
June 30,
  
Six Months Ended
 June 30,
 
   
2015
  
2014
  
2015
  
2014
 
Incentive Stock Options  (1)
            
Quantity
  ---   ---   ---   --- 
Weighted average fair value per share
  ---   ---   ---   --- 
Fair value
  ---   ---   ---   --- 
                  
Nonstatutory Stock Options  (2)
                
Quantity
  ---   ---   ---   --- 
Weighted average fair value per share
  ---   ---   ---   --- 
Fair value
  ---   ---   ---   --- 

 
(1)
The Company did not award any incentive stock options for the three and six months ended June 30, 2015 and 2014, respectively.
 
(2)
The Company did not award any nonstatutory stock options for the three and six months ended June 30, 2015 and 2014, respectively.
Allocated share-based compensation expense
The following table summarizes share-based compensation related to stock options for the three and six months ended June 30:

   
Three Months Ended
 June 30,
  
Six Months Ended
 June 30,
 
   
2015
  
2014
  
2015
  
2014
 
Research and development
 $18,819  $5,365  $37,431  $10,672 
Selling, general and administrative
  51,019   17,018   107,755   36,251 
  Total share-based compensation expense
 $69,838  $22,383  $145,186  $46,923 
Stock option activity
The following table summarizes the stock options outstanding and the number of shares of Common Stock subject to exercise as of June 30, 2015 and the changes therein during the six months then ended:

   
Stock Options
  
Weighted Average Exercise Price per Share
 
Outstanding as of December 31, 2014
  1,699,907  $1.73 
Granted
  ---   --- 
Forfeited/cancelled
  (35,334) $1.77 
Exercised
  ---   --- 
Outstanding as of June 30, 2015
  1,664,573  $1.73 
Stock option grants outstanding and exercisable
The following table presents the stock option grants outstanding and exercisable as of June 30, 2015:

Options Outstanding
  
Options Exercisable
 
Stock Options Outstanding
  
Weighted Average Exercise Price per Share
  
Weighted Average Remaining Contractual Life in Years
  
Stock Options Exercisable
  
Weighted Average Exercise Price per Share
 
 882,500  $0.33   7.7   640,000  $0.33 
 680,000   1.15   7.4   77,500   1.15 
 33,334   2.55   4.8   33,334   2.55 
 68,739   25.07   2.1   68,739   25.07 
 1,664,573  $1.73   7.3   819,573  $2.57 
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LEGAL PROCEEDINGS (Details) - shares
6 Months Ended
May. 01, 2014
Jun. 30, 2015
Apr. 15, 2015
LEGAL PROCEEDINGS [Abstract]      
Number of shares under non-standard cashless exercise (in shares) 782,284    
Number of shares exercisable on cashless basis (in shares) 261,516    
Number of common shares issued on exercise of warrants (in shares)     361,516
Maximum percentage of material proceedings/interest (in hundredths)   5.00%  
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COMMITMENTS AND CONTINGENCIES
6 Months Ended
Jun. 30, 2015
COMMITMENTS AND CONTINGENCIES [Abstract]  
COMMITMENTS AND CONTINGENCIES
NOTE 16.
COMMITMENTS AND CONTINGENCIES

Operating Leases

On January 31, 2006 we entered into a lease agreement for office and laboratory space in Addison, Texas.  The lease commenced on April 1, 2006 and originally continued until April 1, 2013.  The lease required a minimum monthly lease obligation of $9,330, which was inclusive of monthly operating expenses, until April 1, 2011 and at such time increased to $9,776, which was inclusive of monthly operating expenses.  On February 22, 2013, we executed an Amendment to Lease Agreement (the “Lease Amendment”) that renewed and extended our lease until March 31, 2015.  The Lease Amendment required a minimum monthly lease obligation of $9,193, which was inclusive of monthly operating expenses, until March 31, 2014 and at such time, increased to $9,379, which was inclusive of monthly operating expenses.  On March 17, 2015, we executed a Second Amendment to Lease Agreement (the “Second Amendment”) that renewed and extended our lease until March 31, 2018.  The Second Amendment requires a minimum monthly lease obligation of $9,436, which is inclusive of monthly operating expenses.

On December 10, 2010 we entered into a lease agreement for certain office equipment that commenced on February 1, 2011 and continued until February 1, 2015 and required a minimum lease obligation of $744 per month.  On January 16, 2015 we entered into a new lease agreement for certain office equipment.  The new office equipment lease, that commenced on February 1, 2015 and continues until February 1, 2018, requires a minimum lease obligation of $551 per month.

The future minimum lease payments under the 2015 office lease and the 2015 equipment lease are as follows as of June 30, 2015:

Calendar Years
 
Future Lease Expense
 
  2015 (Six months)
 $59,920 
  2016
  119,840 
  2017
  119,840 
  2018
  28,858 
  2019
  --- 
  Total
 $328,458 

Rent expense for our operating leases amounted to $29,837 and $30,446 for the three months ended June 30, 2015 and 2014, respectively, and $61,002 and $60,826 for the six months ended June 30, 2015 and 2014, respectively.

Indemnification

In the normal course of business, we enter into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications. Our exposure under these agreements is unknown because it involves claims that may be made against us in the future, but have not yet been made. To date, we have not paid any claims or been required to defend any action related to our indemnification obligations. However, we may record charges in the future as a result of these indemnification obligations.
 
In accordance with our restated articles of incorporation and our amended and restated bylaws, we have indemnification obligations to our officers and directors for certain events or occurrences, subject to certain limits, while they are serving at our request in their respective capacities. There have been no claims to date and we have a director and officer insurance policy that enables us to recover a portion of any amounts paid for future potential claims. We have also entered into contractual indemnification agreements with each of our officers and directors.

Related Party Transactions and Concentration

On January 17, 2013, the Board of Directors of the Company appointed Helmut Kerschbaumer and Klaus Kuehne to each serve as a director of the Company.

Mr. Kerschbaumer currently serves as a director of Altrazeal Trading GmbH, Altrazeal AG, and Melmed Holding AG (collectively, the “Altrazeal Distributors”) and Mr. Kuehne currently serves as a director of Altrazeal AG.  In such capacities, Mr. Kerschbaumer may be considered, either singularly or collectively, to have control of, and make investment and business decisions on behalf of the Altrazeal Distributors and Mr. Kuehne may be considered, either singularly or collectively, to have control of, and make investment and business decisions on behalf of Altrazeal AG.

Each of Mr. Kerschbaumer and Mr. Kuehne are shareholders of ORADISC GmbH and may be considered, either singularly or collectively, to have control of, and make investment and business decisions on behalf of the ORADISC GmbH.

Currently, we are party to License and Supply Agreements with Altrazeal Trading GmbH, Altrazeal AG, and Melmed Holding AG for the marketing and distribution of Altrazeal in various international territories.  We are also party to a License and Supply Agreement with ORADISC GmbH for the marketing of all applications of our OraDisc™ erodible film technology for dental applications including benzocaine (OraDisc™ B), re-mineralization dental strips, fluoride dental strips, long-acting breath freshener, amlexanox (OraDisc™ A) in certain territories, anti-psychotics, neurologic products, and actives for the treatment of erectile dysfunction.

For the six months ended June 30, 2015 and 2014, the Company recorded revenues, in approximate numbers, of $527,000 and $278,000, respectively, with the various Altrazeal Distributors, which represented 95% and 89% of our total revenues.  As of June 30, 2015 and December 31, 2014, Altrazeal Distributors had an outstanding net accounts receivable, in approximate numbers, of $1,250,000 and $798,000, respectively, which represented 99.8% and 99.5% of our total outstanding accounts receivables.

Purchase of Altrazeal Trading GmbH – May 2015

On May 12, 2015, we entered into a Binding Term Sheet (the “Term Sheet”) with IPMD GmbH, an Austrian limited liability company, and Firnron Ltd., a Cypriot limited liability company (collectively, the “Seller”) related to our purchase of 75% of the share capital of Altrazeal Trading.  We currently own the remaining 25% of share capital of Altrazeal Trading.  Altrazeal Trading is the distributor of Altrazeal® transforming powder dressing in European Union, Australia, New Zealand, Middle East (excluding Jordan and Syria), North Africa, Albania, Bosnia, Croatia, Kosovo, Macedonia, Montenegro, and Serbia.
 
Pursuant to the terms and conditions in the Term Sheet, the purchase price will be composed of 3,150,000 Euro for the purchase of the share capital of Altrazeal Trading and 88,834 Euro for the purchase of product inventory.  The purchase of the share capital of Altrazeal Trading will be paid in installments, with 1,147,200 Euro due at closing (of which 646,500 Euro will be paid with an offset of accounts receivable) and five installment payments of 500,700 Euro due by no later than June 30, 2015, August 31, 2015, October 31, 2015, and December 31, 2015.  The sale is structured as an “installment sale”, with 15% of equity in Altrazeal Trading being transferred upon the payment of each installment by us.  The installments are payable in either cash or in shares of our common stock at our option.  If installment payments are made in common stock, the calculation of shares to be issued will be 110% of the average closing price for the last 10 trading days prior to the installment payment date and include a warrant for 10% of the shares issued with a premium of $0.30 per share to the market price. The purchase of the product inventory for 88,834 Euro will be paid on September 30, 2015.

To the extent we issue shares of common stock to pay the purchase price, we have agreed to register the resale of such shares to the extent possible. The Term Sheet anticipates the negotiation and execution of a purchase agreement containing all terms of the Term Sheet and other standard terms for such a transaction within 60 days.  Such 60 day period expired on July 21, 2015 but both parties are continuing in their efforts to finalize the negotiation and execution of a purchase agreement by no later than November 15, 2015.
 
Related Party Obligations

Since 2011, our named executive officers and certain key executives have temporarily deferred portions of their compensation as part of a plan to conserve the Company’s cash and financial resources.

As of June 30, 2015, the following table summarizes the compensation temporarily deferred and subsequent repayments:

Name
 
2015
  
2014
  
2013
  
2012
  
2011
  
Total
 
  Kerry P. Gray (1) (2) (3)
 $151,806  $(119,986) $(91,000) $220,673  $140,313  $301,806 
  Terrance K. Wallberg
  14,966   (25,000)  (35,769)  24,230   36,539   14,996 
  Total
 $166,772  $(144,986) $(126,769) $244,903  $176,852  $316,772 

 
(1)
During 2015, Mr. Gray temporarily deferred compensation of $151,806 which consisted of $46,806 earned as salary compensation for his duties as President of the Company and $105,000 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors.
 
(2)
During 2014, Mr. Gray temporarily deferred compensation of $150,000 which consisted of $62,500 earned as salary compensation for his duties as President of the Company and $87,500 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors.  During 2014, Mr. Gray was also repaid $269,986 of temporarily deferred compensation, of which $100,000 was used by Mr. Gray for funding required pursuant to the March 2013 Offering.
 
(3)
During 2013, Mr. Gray temporarily deferred compensation of $221,500 which consisted of $11,500 earned pursuant to a Separation Agreement and $210,000 for his duties as Chairman of the Executive Committee of the Company’s Board of Directors.  During 2013, Mr. Gray was also repaid $312,500 of temporarily deferred compensation, of which $300,000 was used by Mr. Gray for funding required pursuant to the March 2013 Offering.

As of June 30, 2015, the Company’s obligation for temporarily deferred compensation was $316,772 of which $124,272 was included in accrued liabilities and $192,500 was included in accounts payable, respectively.

As of December 31, 2014, the Company’s obligation for temporarily deferred compensation was $150,000 of which $62,500 was included in accrued liabilities and $87,500 was included in accounts payable, respectively.

Contingent Milestone Obligations

We are subject to paying Access Pharmaceuticals, Inc. (“Access”) for certain milestones based on our achievement of certain annual net sales, cumulative net sales, and/or our having reached certain defined technology milestones including licensing agreements and advancing products to clinical development.  As of June 30, 2015, the future milestone obligations that we are subject to paying Access, if the milestones related thereto are achieved, total $4,750,000.  Such milestones are based on total annual sales of 20 and 40 million dollars of certain products, annual sales of 20 million dollars of any one certain product, and cumulative sales of such products of 50 and 100 million dollars.

On March 7, 2008, we terminated the license agreement with ProStrakan Ltd. for Amlexanox-related products in the United Kingdom and Ireland.  As part of the termination, we agreed to pay ProStrakan Ltd. a royalty of 30% on any future payments received by us from a new licensee in the United Kingdom and Ireland territories, up to a maximum of $1,400,000.  On November 17, 2008, we entered into a licensing agreement for Amlexanox-related product rights to the United Kingdom and Ireland territories with MEDA AB.
XML 60 R26.htm IDEA: XBRL DOCUMENT v3.2.0.727
INVENTORY (Tables)
6 Months Ended
Jun. 30, 2015
INVENTORY [Abstract]  
Components of inventory
The components of inventory, at the different stages of production, consisted of the following at June 30, 2015 and December 31, 2014:

Inventory
 
June 30, 2015
  
December 31, 2014
 
  Raw materials
 $48,393  $41,648 
  Work-in-progress
  468,573   271,571 
  Finished goods
  21,221   12,438 
  Total
 $538,187  $325,657 
XML 61 R49.htm IDEA: XBRL DOCUMENT v3.2.0.727
FAIR VALUE MEASUREMENTS (Details) - USD ($)
Jun. 30, 2015
Dec. 31, 2014
Promissory Note April 2015 [Member]    
Liabilities [Abstract]    
Promissory note payable $ 550,000 $ 0
XML 62 R41.htm IDEA: XBRL DOCUMENT v3.2.0.727
INVESTMENTS IN UNCONSOLIDATED ENTITIES (Details)
3 Months Ended 6 Months Ended 12 Months Ended
Dec. 31, 2015
EUR (€)
Oct. 31, 2015
EUR (€)
Aug. 31, 2015
EUR (€)
Jun. 30, 2015
EUR (€)
May. 12, 2015
EUR (€)
$ / shares
May. 12, 2015
EUR (€)
Installment
Jun. 30, 2015
USD ($)
Jun. 30, 2014
USD ($)
Jun. 30, 2015
USD ($)
Jun. 30, 2014
USD ($)
Dec. 31, 2014
USD ($)
Dec. 31, 2013
USD ($)
Dec. 31, 2012
USD ($)
Sep. 30, 2015
EUR (€)
Statement of operations [Abstract]                            
Gains losses on equity method investments             $ 0 $ 0 $ 0 $ 0        
Minimum [Member]                            
Schedule of Equity Method Investments [Line Items]                            
Percentage of noncontrolling interest (in hundredths)       20.00%     20.00%   20.00%          
Maximum [Member]                            
Schedule of Equity Method Investments [Line Items]                            
Percentage of noncontrolling interest (in hundredths)       50.00%     50.00%   50.00%          
Altrazeal Trading Ltd. [Member]                            
Schedule of Equity Method Investments [Line Items]                            
Non-dilutable ownership interest (in hundredths)                         25.00%  
Unrecorded profit (loss)                         $ 129,207  
Balance sheet [Abstract]                            
Total assets                         136,661  
Total liabilities                         660,006  
Total stockholders' equity (deficit)                         (523,345)  
Statement of operations [Abstract]                            
Revenues                         61,028  
Net (loss)                         $ (516,829)  
Percentage of voting interest acquired (in hundreds)                         25.00%  
ORADISC GmbH [Member]                            
Schedule of Equity Method Investments [Line Items]                            
Non-dilutable ownership interest (in hundredths)                       25.00%    
Unrecorded profit (loss)                       $ 11,430    
Balance sheet [Abstract]                            
Total assets                       305,069    
Total liabilities                       302,572    
Total stockholders' equity (deficit)                       2,497    
Statement of operations [Abstract]                            
Revenues                       0    
Net (loss)                       (34,671)    
Gains losses on equity method investments             $ 0       $ 0 $ 0    
Percentage of voting interest acquired (in hundreds)                       25.00%    
Altrazeal Trading GmbH [Member]                            
Schedule of Equity Method Investments [Line Items]                            
Non-dilutable ownership interest (in hundredths)       25.00% 75.00% 75.00% 25.00%   25.00%   25.00%      
Unrecorded profit (loss)                     $ 295,477      
Balance sheet [Abstract]                            
Total assets                     1,039,343 $ 757,784    
Total liabilities                     2,178,865 1,563,046    
Total stockholders' equity (deficit)                     (1,139,522) (805,262)    
Statement of operations [Abstract]                            
Revenues                     882,583 0    
Net (loss)                     $ (465,580) $ (798,009)    
Percentage of voting interest acquired (in hundreds)       25.00% 75.00% 75.00% 25.00%   25.00%   25.00%      
Purchase price allocation, share capital | €         € 3,150,000 € 3,150,000                
Purchase price allocation, product inventory | €         € 88,834 88,834                
Purchase price of acquisition, installment amount | €           1,147,200                
Purchase price offset of accounts receivable amount | €           € 646,500                
Number of installments | Installment           5                
Purchase price of share capital, installment amount | €       € 500,700                    
Percentage of equity being transferred on each installment (in hundredths)           15.00%                
Percentage of average closing price of shares (in hundredths)           110.00%                
Number of trading days           10 days                
Percentage of warrants included in installment payment (in hundredths)           10.00%                
Premium per share included in installment payments (in dollars per share) | $ / shares         € 0.30                  
Altrazeal Trading GmbH [Member] | Subsequent Event [Member]                            
Statement of operations [Abstract]                            
Purchase price of share capital, installment amount | € € 500,700 € 500,700 € 500,700                      
Payment for inventory included in working capital | €                           € 88,834
Altrazeal Trading GmbH [Member] | Subsequent Event [Member] | Maximum [Member]                            
Statement of operations [Abstract]                            
Purchase agreement execution period           60 days                
Altrazeal AG [Member]                            
Schedule of Equity Method Investments [Line Items]                            
Non-dilutable ownership interest (in hundredths)       25.00%     25.00%   25.00%          
Statement of operations [Abstract]                            
Gains losses on equity method investments                     $ 0      
Percentage of voting interest acquired (in hundreds)       25.00%     25.00%   25.00%          
XML 63 R5.htm IDEA: XBRL DOCUMENT v3.2.0.727
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($)
6 Months Ended
Jun. 30, 2015
Jun. 30, 2014
OPERATING ACTIVITIES :    
Net loss $ (1,467,652) $ (1,578,006)
Adjustments to reconcile net loss to net cash used in operating activities:    
Amortization of intangible assets 235,622 235,622
Depreciation 104,527 120,107
Share-based compensation for stock and options issued to employees 24,933 9,276
Share-based compensation for options issued to non-employees 120,253 37,647
Equity in earnings (loss) of unconsolidated subsidiary 0 0
Amortization of debt discount on convertible note 0 (78,630)
Amortization of debt discount on promissory note 11,035 0
Amortization of debt issuance costs 8,103 7,309
Warrants issued (cancelled) for services 0 72,771
Common stock issued for services 0 42,600
Common stock issued for interest due on convertible note 0 2,063
Loss on early extinguishment of convertible note 0 135,078
Change in operating assets and liabilities:    
Accounts receivable (450,038) (243,915)
Inventory (212,530) 46,912
Prepaid expenses and deferred charges 77,145 36,063
Notes receivable and accrued interest 0 777,710
Accounts payable 449,744 (343,456)
Accrued liabilities 53,800 (150,742)
Accrued interest 11,764 (859)
Deferred revenue 7,402 (29,237)
Total 441,760 676,319
Net Cash Used in Operating Activities (1,025,892) (901,687)
INVESTING ACTIVITIES :    
Purchase of property and equipment (787) (16,233)
Net Cash Used in Investing Activities (787) (16,233)
FINANCING ACTIVITIES :    
Proceeds from sale of common stock and warrants, net 0 610,000
Proceeds from exercise of common stock warrants 0 1,800,000
Proceeds from issuance of convertible note and warrant, net 485,008 0
Offering cost adjustment - preferred stock sale in 2011 10,509 0
Repayment of principle due on convertible note 0 (776,609)
Net Cash Provided by Financing Activities 495,517 1,633,391
Net Increase (Decrease) in Cash (531,162) 715,471
Cash, beginning of period 550,458 5,119
Cash, end of period 19,296 720,590
SUPPLEMENTAL CASH FLOW DISCLOSURE:    
Cash paid for interest 1,601 14,516
Non-cash investing and financing activities:    
Issuance of common stock for principle due on convertible note $ 0 $ 597,029
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INVENTORY
6 Months Ended
Jun. 30, 2015
INVENTORY [Abstract]  
INVENTORY
NOTE 5.
INVENTORY

As of June 30, 2015, our inventory was composed of Altrazeal® finished goods, manufacturing costs incurred in the production of Altrazeal®, and raw materials.  Inventories are stated at the lower of cost (first in, first out method) or market.  We regularly review inventories on hand and write down the carrying value of our inventories for excess and potentially obsolete inventories based on historical usage and estimated future usage.  In assessing the ultimate realization of our inventories, we are required to make judgments as to future demand requirements.  As actual future demand or market conditions may vary from those projected by us, adjustment to inventories may be required.

The components of inventory, at the different stages of production, consisted of the following at June 30, 2015 and December 31, 2014:

Inventory
 
June 30, 2015
  
December 31, 2014
 
  Raw materials
 $48,393  $41,648 
  Work-in-progress
  468,573   271,571 
  Finished goods
  21,221   12,438 
  Total
 $538,187  $325,657 
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PROPERTY, EQUIPMENT and LEASEHOLD IMPROVEMENTS (Tables)
6 Months Ended
Jun. 30, 2015
PROPERTY, EQUIPMENT and LEASEHOLD IMPROVEMENTS [Abstract]  
Property, equipment and leasehold improvements
Property, equipment and leasehold improvements, net, consisted of the following at June 30, 2015 and December 31, 2014:

Property, equipment and leasehold improvements
 
June 30, 2015
  
December 31, 2014
 
  Laboratory equipment
 $424,888  $424,888 
  Manufacturing equipment
  1,599,894   1,599,894 
  Computers, office equipment, and furniture
  153,865   153,078 
  Computer software
  4,108   4,108 
  Leasehold improvements
  95,841   95,841 
    2,278,596   2,277,809 
  Less: accumulated depreciation and amortization
  (1,950,226)  (1,845,699)
  Property, equipment and leasehold improvements, net
 $328,370  $432,110 
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INVENTORY (Details) - USD ($)
Jun. 30, 2015
Dec. 31, 2014
Components of inventory [Abstract]    
Raw materials $ 48,393 $ 41,648
Work-in-progress 468,573 271,571
Finished goods 21,221 12,438
Total $ 538,187 $ 325,657
XML 68 R20.htm IDEA: XBRL DOCUMENT v3.2.0.727
INCOME TAXES
6 Months Ended
Jun. 30, 2015
INCOME TAXES [Abstract]  
INCOME TAXES
NOTE 15.
INCOME TAXES

There was no current federal tax provision or benefit recorded for any period since inception, nor were there any recorded deferred income tax assets, as such amounts were completely offset by valuation allowances.