0001171843-13-004539.txt : 20131108 0001171843-13-004539.hdr.sgml : 20131108 20131108163111 ACCESSION NUMBER: 0001171843-13-004539 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 12 CONFORMED PERIOD OF REPORT: 20130930 FILED AS OF DATE: 20131108 DATE AS OF CHANGE: 20131108 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CLEVELAND BIOLABS INC CENTRAL INDEX KEY: 0001318641 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 200077155 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-32954 FILM NUMBER: 131205137 BUSINESS ADDRESS: STREET 1: 73 HIGH STREET CITY: BUFFALO STATE: NY ZIP: 14203 BUSINESS PHONE: (716) 849-6810 MAIL ADDRESS: STREET 1: 73 HIGH STREET CITY: BUFFALO STATE: NY ZIP: 14203 10-Q 1 f10q_110813.htm FORM 10-Q f10q_110813.htm
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
 
WASHINGTON, D.C. 20549
 
FORM 10-Q
 
(Mark One)
[X]  QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the quarterly period ended September 30, 2013
 
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 001-32954
 
CLEVELAND BIOLABS, INC.
(Exact name of registrant as specified in its charter)
 
DELAWARE
 
20-0077155
(State or other jurisdiction of incorporation or organization)
 
(I.R.S. Employer Identification No.)
     
73 High Street, Buffalo, New York
 
14203
(Address of principal executive offices)
 
(Zip Code)
 
(Registrant’s telephone number, including area code) (716) 849-6810
 
_______________________________________________
(Former name, former address and former fiscal year,
if changed since last report)
 
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 [X]  No  [   ]
 
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  Yes [X]   No [   ]
 
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 accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
 
Large accelerated filer [   ]
Accelerated filer [X]
 
Non-accelerated filer [   ]
 
Smaller reporting company [   ]
 
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes [   ]  No [X]
 
As of November 5, 2013, there were 45,182,114 shares outstanding of registrant's common stock, par value $0.005 per share.
 
 
1

 
 
CLEVELAND BIOLABS INC. AND SUBSIDIARIES
10-Q
 
TABLE OF CONTENTS
PAGE
     
PART I - FINANCIAL INFORMATION
 
     
     
 
     
 
     
 
     
 
     
  Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2013 and 2012 7
     
 
     
     
     
     
PART II - OTHER INFORMATION
 
     
     
     
     
     
     
     
     

In this report, except as otherwise stated or the context otherwise requires, the terms “Cleveland BioLabs” and “CBLI” refer to Cleveland BioLabs, Inc., but not its consolidated subsidiaries and the “Company,” “we,” “us” and “our” refer to Cleveland BioLabs, Inc. together with its consolidated subsidiaries. Our common stock, par value $0.005 per share, is referred to as “common stock.”
 
 
2

 
 
   
September 30,
2013
   
December 31,
2012
 
   
(unaudited)
       
ASSETS
           
Current assets:
           
Cash and cash equivalents
  $ 14,312,921     $ 25,652,083  
Short-term investments
    309,166       2,633,944  
Accounts receivable
    603,494       41,896  
Other current assets
    590,714       1,078,040  
Total current assets
    15,816,295       29,405,963  
                 
                 
Equipment, net
    825,746       986,553  
Restricted cash
    2,871,553       1,577,920  
Other long-term assets
    174,822       39,597  
                 
Total assets
  $ 19,688,416     $ 32,010,033  
                 
LIABILITIES AND STOCKHOLDERS' EQUITY
               
                 
Current liabilities:
               
Accounts payable
  $ 1,202,198     $ 1,523,875  
Accrued expenses
    3,082,585       2,410,592  
Deferred revenue
    2,035,120       3,314,918  
Accrued warrant liability
    3,594,741       4,105,659  
Current portion of capital lease obligation
    80,709       71,679  
Total current liabilities
    9,995,353       11,426,723  
                 
Noncurrent portion of capital lease obligation
    29,560       97,602  
Long-term debt
    7,330,449       -  
                 
Commitments and contingencies
    -       -  
                 
Total liabilities
    17,355,362       11,524,325  
                 
Stockholders' equity:
               
Preferred stock, $.005 par value; 10,000,000 shares authorized, 0 shares issued and outstanding as of September 30, 2013 and December 31, 2012, respectively
    -       -  
Common stock, $.005 par value; 160,000,000 shares authorized, 45,157,114 shares issued and outstanding as of September 30, 2013; 80,000,000 shares authorized, 44,730,445 issued and outstanding as of December 31, 2012
    225,786       223,653  
Additional paid-in capital
    125,398,821       123,864,830  
Accumulated other comprehensive income
    307,414       546,473  
Accumulated deficit
    (135,199,419 )     (118,301,789 )
Total Cleveland BioLabs, Inc. stockholders' (deficit) equity
    (9,267,398 )     6,333,167  
Noncontrolling interest in stockholders' equity
    11,600,452       14,152,541  
Total stockholders' equity
    2,333,054       20,485,708  
                 
Total liabilities and stockholders' equity
  $ 19,688,416     $ 32,010,033  
 
See Notes to Consolidated Financial Statements
 
 
3

 
 
CLEVELAND BIOLABS, INC. AND SUBSIDIARIES
   
For the Three Months Ended September 30,
   
For the Nine Months Ended September 30,
 
   
2013
   
2012
   
2013
   
2012
 
Revenues:
                       
Grants and contracts
  $ 1,635,600     $ 219,575     $ 4,616,334     $ 1,409,209  
                                 
Operating expenses:
                               
Research and development
    4,205,238       4,841,324       14,909,882       16,920,400  
General and administrative
    3,286,830       3,219,792       9,787,053       8,973,949  
Total operating expenses
    7,492,068       8,061,116       24,696,935       25,894,349  
                                 
Loss from operations
    (5,856,468 )     (7,841,541 )     (20,080,601 )     (24,485,140 )
                                 
Other income (expense):
                               
Interest and other income
    97,534       228,580       225,299       354,473  
Foreign exchange gain (loss)
    (15,057 )     (278,940 )     59,853       (330,024 )
Change in value of warrant liability
    1,163,030       (4,423,775 )     510,919       (160,749 )
Total other income (expense)
    1,245,507       (4,474,135 )     796,071       (136,300 )
                                 
Net loss
    (4,610,961 )     (12,315,676 )     (19,284,530 )     (24,621,440 )
                                 
                                 
Net loss attributable to noncontrolling interests
    519,765       1,437,840       2,386,900       3,277,774  
                                 
Net loss attributable to Cleveland BioLabs, Inc.
  $ (4,091,196 )   $ (10,877,836 )   $ (16,897,630 )   $ (21,343,666 )
                                 
Net loss available to common stockholders per share of common stock, basic and diluted
  $ (0.09 )   $ (0.30 )   $ (0.38 )   $ (0.60 )
                                 
Weighted average number of shares used in calculating net loss per share, basic and diluted
    45,061,274       35,879,245       44,946,340       35,761,260  

See Notes to Consolidated Financial Statements
 
 
4

 
 
CLEVELAND BIOLABS, INC. AND SUBSIDIARIES
 
   
For the Three Months Ended September 30,
   
For the Nine Months Ended September 30,
 
   
2013
   
2012
   
2013
   
2012
 
                         
Net loss including noncontrolling interests
  $ (4,610,961 )   $ (12,315,676 )   $ (19,284,530 )   $ (24,621,440 )
Other comprehensive income (loss)
                               
Foreign currency translation adjustment
    35,821       593,124       (404,248 )     658,888  
                                 
Comprehensive loss including noncontrolling interests
    (4,575,140 )     (11,722,552 )     (19,688,778 )     (23,962,552 )
Comprehensive loss attributable to noncontrolling interests
    502,891       1,182,641       2,552,089       2,997,934  
                                 
Comprehensive loss attributable to Cleveland BioLabs, Inc.
  $ (4,072,249 )   $ (10,539,911 )   $ (17,136,689 )   $ (20,964,618 )
 
See Notes to Consolidated Financial Statements
 
 
5

 
 
CLEVELAND BIOLABS, INC. AND SUBSIDIARIES
   
Common Stock
   
Additional
Paid-in
   
Accumulated
Other
Comprehensive
   
Accumulated
   
Noncontrolling
       
   
Shares
   
Amount
   
Capital
   
Income (Loss)
   
Deficit
   
Interests
   
Total
 
                                           
Balance at December 31, 2012
    44,730,445     $ 223,653     $ 123,864,830     $ 546,473     $ (118,301,789 )   $ 14,152,541     $ 20,485,708  
                                                         
Stock based compensation
    416,988       2,085       1,403,648                               1,405,733  
Exercise of options
    9,681       48       12,344                               12,392  
Allocation of debt proceeds to fair value of warrants
            117,999                               117,999  
Net loss
                                    (16,897,630 )     (2,386,900 )     (19,284,530 )
Foreign currency translation
                            (239,059 )             (165,189 )     (404,248 )
                                                         
Balance at September 30, 2013
    45,157,114     $ 225,786     $ 125,398,821     $ 307,414     $ (135,199,419 )   $ 11,600,452     $ 2,333,054  
 
See Notes to Consolidated Financial Statements
 
 
6

 
 
CLEVELAND BIOLABS, INC. AND SUBSIDIARIES
   
For the Nine Months Ended September 30,
 
   
2013
   
2012
 
Cash flows from operating activities:
           
Net loss
  $ (19,284,530 )   $ (24,621,440 )
Adjustments to reconcile net income (loss) to net cash used in operating activities:
         
Depreciation
    284,278       376,814  
Unrealized loss on short-term investments
    -       138,910  
Noncash compensation
    1,591,986       2,272,020  
Change in value of warrant liability
    (510,919 )     160,749  
Changes in operating assets and liabilities:
               
Accounts receivable
    (565,336 )     1,695,870  
Other current assets
    452,798       (435,305 )
Other long-term assets
    (3,995 )     (2,554 )
Accounts payable
    (310,150 )     (471,635 )
Deferred revenue
    (1,102,472 )     3,821,991  
Accrued interest
    18,448       -  
Accrued expenses
    506,750       1,609,369  
Net cash used in operating activities
    (18,923,142 )     (15,455,211 )
                 
Cash flows from investing activities:
               
Purchase of short-term investments
    -       (4,898,314 )
Sale of short-term investments
    2,213,999       3,560,812  
Purchase of equipment
    (125,218 )     (154,742 )
Increase in restricted cash
    (1,421,861 )     -  
Net cash provided by (used in) investing activities
    666,920       (1,492,244 )
                 
Cash flows from financing activities:
               
Noncontrolling interest capital contribution to Incuron, LLC
    -       5,893,557  
Net proceeds from issuance of debt
    7,297,675       -  
Exercise of options
    12,392       1,425  
Repayment of capital lease obligation
    (59,012 )     (36,029 )
Net cash provided by financing activities
    7,251,055       5,858,953  
                 
Effect of exchange rate change on cash and equivalents
    (333,995 )     404,486  
                 
Decrease in cash and cash equivalents
    (11,339,162 )     (10,684,016 )
                 
Cash and cash equivalents at beginning of period
    25,652,083       22,872,589  
                 
Cash and cash equivalents at end of period
  $ 14,312,921     $ 12,188,573  
                 
Supplemental disclosure of cash flow information:
               
Cash paid during the period for interest
  $ 17,105     $ 17,253  
                 
Supplemental schedule of noncash financing activities:
               
Fair value of warrants issued in connection with debt
  $ 117,999     $ -  
Equipment acquired through lease financing
  $ -     $ 221,690  
 
See Notes to Consolidated Financial Statements
 
 
7

 
 
CLEVELAND BIOLABS, INC. AND SUBSIDIARIES
 
(UNAUDITED)

1. Description of Business
 
Cleveland BioLabs, Inc. (“CBLI”) is a clinical-stage biotechnology company with a focus on oncology and acute radiation syndrome drug development. Since inception, CBLI has pursued the research, development and commercialization of products that have the potential to treat cancer, reduce death from total body irradiation and counteract the toxic effects of radio- and chemotherapies for oncology patients.

CBLI is incorporated under the laws of the State of Delaware and is headquartered in Buffalo, New York. CBLI has one wholly-owned operating subsidiary, BioLab 612, LLC (“BioLab 612”), which began operations in 2012. CBLI also has two majority-owned operating subsidiaries, Incuron, LLC (“Incuron”) and Panacela Labs, Inc. (“Panacela”), which were formed in 2010 and 2011, respectively. Additionally, Panacela has a wholly-owned operating subsidiary, Panacela Labs, LLC.
 
2. Summary of Significant Accounting Policies
 
Basis of Presentation and Consolidation
 
The accompanying consolidated financial statements include the accounts of CBLI and its subsidiaries, BioLab 612, Incuron and Panacela, collectively referred to herein as the “Company.” All significant intercompany balances and transactions have been eliminated in consolidation.
 
The unaudited consolidated financial statements included herein have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission ("SEC"). Certain information and footnote disclosures normally included in consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles have been condensed or omitted pursuant to such rules and regulations. These consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012, as amended, as filed with the SEC..
 
In the opinion of the Company’s management, any adjustments contained in the accompanying unaudited consolidated financial statements are of a normal recurring nature, and are necessary to present fairly the financial position of the Company as of September 30, 2013, along with its results of operations for the three and nine month periods ended September 30, 2013 and 2012 and cash flows for the nine month periods ended September 30, 2013 and 2012.  Interim results are not necessarily indicative of results that may be expected for any other interim period or for an entire year.
 
Recent Accounting Pronouncements

In July 2013, the FASB issued ASU No. 2013-11, “Income Taxes (Topic 740): Presentation of an Unrecognized Tax Benefit When a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists (a consensus of the FASB Emerging Issues Task Force)” (“ASU 2013-11”). The amendments of ASU 2013-11 provide entities with guidance of how to present a provision for uncertain tax positions in the financial statements when a net operating loss carryforward, a similar tax loss, or a tax credit carryforward exists. For public entities, the amendments are effective for fiscal years and interim reporting periods beginning after December 15, 2013. The Company does not believe that the adoption of this standard will have a material impact on its consolidated financial statements.

Use of Estimates
 
The preparation of financial statements in conformity with accounting principles generally accepted in the United States (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, 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.  Actual results could differ from those estimates.
 
Cash and Cash Equivalents
 
Of the $14.3 million and $25.7 million of cash and cash equivalents at September 30, 2013 and December 31, 2012, respectively, $1.5 million and $13.0 million, respectively, consisted of highly liquid investments with maturities of 90 days or less when purchased.  These investments consist of commercial paper, short-term debt securities, time deposits and investments in money market funds with commercial banks and financial institutions. As of September 30, 2013, $3.5 million of the Company's cash and cash equivalents was restricted to the use of its majority-owned subsidiaries, leaving $10.8 million available for general use.
 
 
8

 
 
Short-Term Investments
 
The Company’s short-term investments are classified as held to maturity given the intent and ability to hold the investments to maturity. Accordingly, these investments are carried at amortized cost. Short-term investments classified as held-to-maturity consisted of certificates of deposit with maturity dates beyond three months and less than one year. As of September 30, 2013, all of the Company’s short-term investments were restricted to use by its majority-owned subsidiaries.

Significant Customers and Accounts Receivable
 
Grant and contract revenue from the U.S. government accounted for 48.1% and 39.5% of total revenue for the three and nine months ended September 30, 2013, respectively, and 23.2% and 88.0% of total revenue for the three and nine months ended September 30, 2012, respectively.
 
Grant and contract revenue received by the Company’s subsidiaries from Russian government agencies accounted for 51.9% and 60.5% of total consolidated revenues for the three and nine months ended September 30, 2013, respectively, and 76.8% and 12.0% of total consolidated revenue for the three and nine months ended September 30, 2012, respectively.
 
Although the Company anticipates ongoing U.S. and Russian government contract and grant revenue, there is no guarantee that these revenue streams will continue in the future.
 
Accounts receivable consist of amounts due under reimbursement contracts with certain government and foreign entities. The Company extends unsecured credit to customers under normal trade agreements, which generally require payment within 30 days.
 
Management estimates an allowance for doubtful accounts that is based upon management's review of delinquent accounts and an assessment of the Company's historical evidence of collections. There were no allowances for doubtful accounts as of September 30, 2013 and December 31, 2012, as the collection history from the Company’s customers indicated that collection was probable.
 
Intellectual Property
 
Costs related to filing and pursuing patent applications are recognized as general and administrative expenses (“G&A expenses”) as incurred, since the recoverability of such expenditures is uncertain. Upon marketing approval by the U.S. Food and Drug Administration (“FDA”) or a respective foreign governing body, such costs will be capitalized and depreciated over the expected life of the related patent.
 
Accounting for Stock-Based Compensation
 
The 2006 Equity Incentive Plan, as amended (the “Plan”), authorizes CBLI to grant (i) options to purchase common stock, (ii) restricted or unrestricted stock units, and (iii) stock appreciation rights, so long as the exercise or grant price of each are at least equal to the fair market value of the stock on the date of grant. As of September 30, 2013, an aggregate of 10.0 million shares of common stock were authorized for issuance under the Plan, of which a total of approximately 2.1 million shares of common stock remained available for future awards. A single participant cannot be awarded more than 400,000 shares annually. Awards granted under the Plan have a contractual life of no more than 10 years. The terms and conditions of equity awards (such as price, vesting schedule, term and number of shares) under the Plan are specified in an award document, and approved by the Company’s compensation committee.

In June 2013 the Company’s stockholders approved the 2013 Employee Stock Purchase Plan (“ESPP”) which provides a means by which eligible employees of the Company and certain designated related corporations may be given an opportunity to purchase shares of Common Stock. As of September 30, 2013, there are 2.1 million shares of Common Stock reserved for purchase under the ESPP. The number of shares reserved for purchase under the ESPP increases on January 1 of each calendar year by the lesser of (i) 10% of the total number of shares of Common Stock outstanding on December 31st of the preceding year, or (ii) 200,000 shares of Common Stock. The ESPP allows employees to use up to 15% of their compensation to purchase shares of Common Stock at an amount equal to 85% of the fair market value of the Company’s Common Stock on the offering date or the purchase date, whichever is less.
 
The Company utilizes the Black-Scholes valuation model for estimating the fair value of all stock options granted where the vesting period is based on length of service or performance, while a Monte Carlo simulation model is used for estimating the fair value of stock options with market-based vesting conditions. Set forth below are the assumptions used in valuing the stock options granted and a discussion of the Company’s methodology for developing each of the assumptions used: 
 
 
9

 
 
     
For the nine months ended September 30,
   
 
 
 
2013
   
2012
   
                 
 
Risk-free interest rate
    0.02 - 1.92 %     0.71 - 1.49 %  
 
Expected dividend yield
        0 %         0 %  
 
Expected life (in years)
    5 - 7.3       5 - 6    
 
Expected volatility
    80.71 - 89.66 %     86.58 - 92.24 %  

“Risk-free interest rate” means the range of U.S. Treasury rates with a term that most closely resembles the expected life of the option as of the date the option is granted.

“Expected dividend yield” means the Company does not pay regular dividends on its common stock and does not anticipate paying any dividends in the foreseeable future.

“Expected life” means the period of time that options granted are expected to remain outstanding, based wholly on the use of the simplified (safe harbor) method. The simplified method is used because the Company does not yet have adequate historical exercise information to estimate the expected life the options granted.

“Expected volatility” means a measure of the amount by which a financial variable, such as share price, has fluctuated (historical volatility) or is expected to fluctuate (implied volatility) during a period. Expected volatility is based on the Company’s historical volatility and incorporates the volatility of the common stock of comparable companies when the expected life of the option exceeds the Company’s trading history.

Income Taxes
 
No income tax expense was recorded for the three and nine months ended September 30, 2013 and 2012, as the Company does not expect to have taxable income for 2013 and did not have taxable income in 2012. A full valuation allowance has been recorded against the Company’s deferred tax asset.
 
Earnings (Loss) per Share
 
Basic net income (loss) per share of common stock excludes dilution for potential common stock issuances and is computed by dividing net income (loss) by the weighted average number of shares outstanding for the period. Diluted net income (loss) per share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock. Diluted net loss per share is identical to basic net loss per share as potentially dilutive securities have been excluded from the calculation of diluted net loss per common share because the inclusion of such securities would be antidilutive.
 
The Company has excluded the following outstanding warrants and options from the calculation of diluted net loss per share because all such securities were antidilutive for the periods presented:
 
     
As of September 30,
   
 
Common Equivalent Securities
 
2013
   
2012
   
                 
 
Warrants
    10,534,245       6,065,495    
 
Options
    5,608,912       4,816,012    
                     
 
Total
    16,143,157       10,881,507    

Contingencies
 
From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of business.  The Company accrues for liabilities when it is probable that future expenditures will be made and such expenditures can be reasonably estimated.  For all periods presented, the Company is not a party to any pending material litigation or other material legal proceedings.

 
10

 
 
3.  Fair Value of Financial Instruments

The Company measures and records warrant liabilities at fair value in the accompanying financial statements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability, an exit price, in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value, includes:
 
Level 1 - Observable inputs for identical assets or liabilities such as quoted prices in active markets;
Level 2 - Inputs other than quoted prices in active markets that are either directly or indirectly observable; and
Level 3 - Unobservable inputs in which little or no market data exists, which are therefore developed by the Company using estimates and assumptions that reflect those that a market participant would use.

The following tables represent the Company’s fair value hierarchy for its financial liabilities measured at fair value on a recurring basis as of September 30, 2013 and December 31, 2012:
 
   
As of September 30, 2013
 
   
Level 1
   
Level 2
   
Level 3
   
Total
 
Liabilities:
                       
Compensatory stock options not yet issued (1)
  $ -     $ -     $ 166,783     $ 166,783  
Accrued warrant liability
    -       -       3,594,741       3,594,741  
                                 
Total liabilities
  $ -     $ -     $ 3,761,524     $ 3,761,524  
 
   
As of December 31, 2012
 
   
Level 1
   
Level 2
   
Level 3
   
Total
 
Liabilities:
                       
Accrued warrant liability
  $ -     $ -     $ 4,105,659     $ 4,105,659  
                                 
Total liabilities
  $ -     $ -     $ 4,105,659     $ 4,105,659  
 
 (1) Included in accrued expenses in the accompanying consolidated balance sheets.
 
The Company uses the Black-Scholes model to measure the accrued warrant liability and its accrual for compensatory stock options not yet issued. The following are the assumptions used to measure the accrued warrant liability at September 30, 2013 and December 31, 2012, which were determined in a manner consistent with that described for grants of options to purchase common stock as set forth in Note 2:
 
   
September 30, 2013
   
December 31, 2012
 
             
Stock Price
  $     1.57     $     1.33  
Exercise Price
  $ 1.60 - 5.00     $ 1.60 - 5.00  
Term in years
    0.71 - 2.03       1.09 - 2.41  
Volatility
    48.41 - 79.57 %     82.75 - 95.91 %
Annual rate of quarterly dividends
        0 %         0 %
Discount rate- bond equivalent yield
    .07 - .34 %     .17 - .29 %
 
The following are the assumptions used to measure the compensatory stock options not yet issued at September 30, 2013:
 
     
September 30, 2013
   
           
 
Stock price
  $ 1.57    
 
Term in years
    5    
 
Volatility
    79.93 %  
 
Annual rate of quarterly dividends
    0 %  
 
Discount rate - bond equivalent yield
    1.40 %  
 
 
11

 
 
The following table sets forth a summary of changes in the fair value of the Company’s Level 3 fair value measurements for the nine months ended September 30, 2013 and 2012: 
 
   
Three months ended September 30, 2013
   
Nine months ended September 30, 2013
 
   
Accrued Warrant
Liability
      Compensatory
Stock Options
Not Yet Issued
    Accrued Warrant
Liability
   
Compensatory
Stock Options
Not Yet Issued
 
                         
Beginning balance
  $ 4,757,770     $ 63,838     $ 4,105,659     $ -  
Total (gains) or losses, realized and unrealized, included in earnings (1)(2)
    (1,163,029 )     -       (510,918 )     -  
Estimates and other changes in fair value
    -       102,945       -       166,783  
Settlements
    -       -       -       -  
                                 
Balance, September 30, 2013
  $ 3,594,741     $ 166,783     $ 3,594,741     $ 166,783  
 
   
Three months ended September 30, 2012
   
Nine months ended September 30, 2012
 
     
Accrued Warrant
Liability
      Compensatory
Stock Options
Not Yet Issued
     
Accrued Warrant
Liability
   
Compensatory
Stock Options
Not Yet Issued
 
                         
Beginning balance
  $ 3,022,933     $ 114,617     $ 7,285,959     $ 378,750  
Total (gains) or losses, realized and unrealized, included in earnings (1)(2)
    4,423,775       -       160,749       51,823  
Estimates and other changes in fair value
    -       169,708       -       284,325  
Settlements
    -       -       -       (430,573 )
                                 
Balance, September 30, 2012
  $ 7,446,708     $ 284,325     $ 7,446,708     $ 284,325  
 
(1)
Unrealized gains or losses related to the accrued warrant liability were included as change in value of accrued warrant liability. There were no realized gains or losses for the three and nine month periods ended September 30, 2013 and 2012.
(2)
Expenses recorded for compensatory stock options not yet issued are included in research & development expense and general and administrative expense.
 
As of September 30, 2013 and December 31, 2012, the Company had no assets or liabilities that were measured at fair value on a nonrecurring basis.

The Company considers the accrued warrant liability and compensatory stock options not yet issued to be Level 3 because some of the inputs into the measurements are neither directly or indirectly observable. Both the accrued warrant liability and compensatory stock options not yet issued use management’s estimate for the expected term, which is based on the safe harbor method as historical exercise information over the term of each security is not readily available. Additionally, the number of compensatory options awarded involves an estimate of management’s performance in relation to the targets set forth in the Company's Executive Compensation Plan. The following table summarizes the unobservable inputs into the fair value measurements:

   
September 30, 2013
 
Description
 
Fair Value
   
Valuation Technique
 
Unobservable Input
 
Range
 
                     
Compensatory stock options not yet issued
  $ 166,783    
Black-scholes pricing model
 
Expected term
    5  
               
Quantity of options
    220,833  
                         
Accrued warrant liability
    3,594,741    
Black-scholes pricing model
 
Expected term
    0.71   -   2.03  
                         
    $ 3,761,524                  
 
Management believes the value of both the accrued warrant liability and compensatory stock options is more sensitive to a change in the Company’s stock price at the end of the respective reporting period as opposed to a change in one of the unobservable inputs described above.

The carrying amounts of the Company’s short-term financial instruments, which include cash and cash equivalents, short-term investments, accounts receivable and accounts payable, approximate their fair values due to their short maturities.

4. Debt

On September 30, 2013, CBLI entered into a Loan and Security Agreement (the “Loan Agreement”) with Hercules Technology II, L.P. (“Hercules”) pursuant to which the company issued a $6 million note and received net proceeds of $5.9 million. The loan bears interest at the greater of (i) 10.45% per annum or (ii) 10.45% plus the prevailing prime rate minus 4.25%. The loan matures on January 1, 2017, and requires interest-only payments for the initial 12 months and principal and interest payments in 27 monthly installments thereafter.  If, prior to June 30, 2014, and subject to Hercules’ approval, CBLI obtains a contract award from the Biomedical Advanced Research Development Authority (“BARDA”) or other funding sources sufficient to fund a series of studies for Entolimod as a radiation countermeasure, which would reasonably be expected to provide a basis for submitting a Biological License Application (“BLA”) to the FDA for licensure of Entolimod as a radiation countermeasure, CBLI may obtain an additional $4 million in loan proceeds at its option.

 
12

 
 
In connection with the Loan Agreement, CBLI granted a first priority lien in substantially all of CBLI’s assets (exclusive of intellectual property). The Loan Agreement also contains representations and warranties by CBLI and Hercules, indemnification provisions in favor of Hercules, customary covenants (including limitations on other indebtedness, liens, acquisitions, investments and dividends, and not including financial covenants), and events of default (including payment defaults, breaches of covenants, material adverse events and events leading to bankruptcy or insolvency). Prepayment of the loan is subject to a penalty rate applied to the balance of the secured obligation and ranges from 1% to 3% based on the date the loan is prepaid. Additionally, Hercules has a right to participate in subsequent private placements of CBLI equity securities at the same price, terms and conditions as other investors, up to an aggregate amount of $1 million.

As additional consideration for the loan, CBLI issued Hercules a five-year warrant to purchase 156,250 shares of CBLI common stock at an exercise price of $1.60 per share. CBLI recorded the fair value of the warrant of $117,999 as equity and as a discount to the carrying value of the loan.  The fair value of the warrant was calculated using the Black-Scholes option pricing model with the following assumptions:

 
Risk-free interest rate
    0.48 %  
 
Expected dividend yield
    0.00 %  
 
Expected life (years)
    2.50    
 
Expected volatility
    82.29 %  

Reflected as a discount to the loan are the following items: the warrant, a $100,000 facility fee CBLI paid to Hercules which was deducted from the gross proceeds of the loan, and a $550,000 payment that is due upon full repayment of the loan or on the maturity date, whichever occurs sooner. In connection with the closing of the loan, CBLI incurred $102,000 in debt issuance costs, primarily related to legal fees, which are included in non-current assets in our consolidated balance sheet. CBLI will amortize the loan discounts and debt issuance costs to interest expense over the term of the loan using the effective interest rate method, which approximates 16.6%. Additionally, the $550,000 end-of-term charge is also reflected as a long-term liability in conjunction with the $6 million note.

The following schedule shows the payments for principal and the end of term charge on the loan by calendar year:

 
2013
  $ -    
 
2014
    351,527    
 
2015
    2,246,215    
 
2016
    2,495,163    
 
2017
    1,457,095    
 
Total
  $ 6,550,000    

On September 3, 2013, Panacela entered into a Master Agreement (the “Panacela Loan”) with Open Joint Stock Company “Rusnano” and CBLI pursuant to which Panacela issued a $1,530,000 note to Rusnano. The Panacela Loan bears interest at a rate of 16.3% per annum and matures on September 3, 2015, at which time Panacela must repay all unpaid principal and accrued interest. Prior to March 3, 2015, the loan is mandatorily convertible into shares of Panacela preferred stock at a conversion price of $1,057 per share if Panacela completes a qualified financing in accordance with the terms of the Panacela Loan.  Subsequent to March 3, 2015, Rusnano has the option to convert the unpaid principal plus interest into shares of Panacela Preferred Stock at a conversion price of $1,057 per share, or if Panacela has a qualified financing event, at a discounted price of 0.75 times the purchase price per share.

In connection with the Panacela Loan, CBLI issued Rusnano a warrant  that has an exercise period that begins upon an event of default on the Panacela Loan and expires on December 31, 2016. Upon an event of default, Rusnano has the option to assign 69.2% of the unpaid principal and interest under the Panacela Loan to CBLI in exchange for shares of CBLI common stock at a price of $1.694 per share.

 
13

 
 
5. Stockholders’ Equity
 
The Company has granted options to purchase shares of common stock and shares of restricted stock. The following is a summary of option award activity during the nine months ended September 30, 2013:

   
Nine months ended September 30, 2013
 
   
Total Stock
Options
Outstanding
   
Weighted Average
Exercise Price per
Share
   
Nonvested Stock
Options
   
Weighted Average
Grant Date Fair
Value per Share
 
                         
December 31, 2012
    5,016,916     $ 4.54       404,500     $ 2.30  
Granted
    898,604       1.67       898,604       1.21  
Vested
    -       -       (506,875 )     1.69  
Exercised
    (9,681 )     1.28       -       -  
Forfeited, Canceled
    (296,927 )     3.66       (151,250 )     0.97  
                                 
September 30, 2013
    5,608,912     $ 4.13       644,979     $ 1.56  
 
The following is a summary of outstanding stock options as of September 30, 2013:

   
As of September 30, 2013
 
   
Stock Options
Outstanding
   
Vested Stock
 Options
 
             
Quantity
    5,608,912       4,963,933  
Weighted-average exercise price
  $ 4.13     $ 4.39  
Weighted Average Remaining Contractual Term (in Years)
    7.01       6.72  
Intrinsic value
  $ 134,340     $ 122,487  
 
For the nine months ended September 30, 2013 and 2012, the Company granted 898,604 and 739,500 stock options, respectively, with a weighted-average grant date fair value of $1.21 and $1.53, respectively. For the nine months ended September 30, 2013 and 2012, the total fair value of options vested was $858,037 and $1,246,720, respectively. The total intrinsic value of options exercised for the nine months ended September 30, 2013 and 2012 was $5,736 and $1,500, respectively.

As of September 30, 2013, total compensation cost not yet recognized related to nonvested stock options was $606,070.  The Company expects to recognize this cost over a weighted average period of approximately 0.85 years.

6. Warrants
 
In connection with sales of the Company’s common stock and the issuance of debt instruments, warrants were issued with exercise prices ranging from $1.60 to $5.00.  The warrants expire between one and seven years from the date of grant, subject to the terms applicable in the agreement.  As of September 30, 2013, the Company had warrants outstanding that are exercisable into 10,534,245 shares of common stock, with a weighted average exercise price of $2.70 per share. The Rusnano Warrant (as described in more detail in Note 4) is not included in the 10,534,245 shares of common stock as Panacela is not in default under the Panacela Loan.

During the three months ended September 30, 2013, CBLI issued warrants to Rusnano and Hercules in connection with the respective loan agreements. The Panacela Loan triggered a reduction in the exercise price of the Company’s warrants issued in March 2010 from $2.00 per share to $1.694 per share. The March 2010 warrant exercise price was further reduced to $1.60 per share in connection with the closing of the Hercules Loan.
 
 
14

 
 

This management's discussion and analysis of financial condition and results of operations and other portions of this filing contain forward-looking information that involves risks and uncertainties. In some cases, you can identify forward-looking statements by terms such as “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” and similar expressions intended to identify forward-looking statements. Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties, and because of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not transpire. We discuss many of these risks in Item 1A under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2012, as amended, and in subsequent filings, including in Item 1A under the heading “Risk Factors” in this Quarterly Report on Form 10-Q.  Factors that may cause such differences include, but are not limited to, availability and cost of financial resources, results of our research and development efforts and clinical trials, product demand, market acceptance and other factors discussed below and in our other SEC filings, including our Annual Report on Form 10-K for the year ended December 31, 2012, as amended. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent our estimates and assumptions only as of the date of this document.  You should read this document with the understanding that our actual future results may be materially different from what we expect. Except as required by law, we do not undertake any obligation to publicly update or revise any forward-looking statements contained in this report, whether as a result of new information, future events or otherwise. This management's discussion and analysis of financial condition and results of operations should be read in conjunction with our financial statements and the related notes included elsewhere in this filing and in our Annual Report on Form 10-K for the year ended December 31, 2012, as amended.
 
OVERVIEW
 
We are a clinical-stage biotechnology company with a focus on oncology drug development whose lead drug candidate, Entolimod, is being developed for dual indications: under the U.S. Food and Drug Administration (“FDA”) regulation commonly referred to as the “Animal Rule” as a radiation countermeasure; and under the FDA’s traditional drug approval pathway as a cancer immunotherapy. Our other compounds are being developed under the FDA’s traditional drug approval pathway for oncology therapeutic purposes and other indications. Since our inception, we have pursued the research, development and commercialization of products that have the potential to treat cancer, reduce death from total body irradiation and counteract the side effects of radio- and chemotherapies for oncology patients. Presently, nine product candidates are under development directly by us and our subsidiaries.

See “Part I, Item 1. Business” in our Annual Report on Form 10-K for the year ended December 31, 2012, as amended, for more information on our product candidates.

Critical Accounting Policies and Significant Estimates

Our discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). The preparation of these financial statements requires us to make estimates and judgments that affect our reported amounts of assets, liabilities, revenues and expenses.

On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses, income taxes, stock-based compensation, investments and in-process research and development. We based our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the reported amounts of revenues and expenses that are not readily apparent from other sources. Actual results may differ from these estimates.
 
Our critical accounting policies and significant estimates are detailed in our Annual Report on Form 10-K for the year ended December 31, 2012, as amended. Other than as set forth below, our critical accounting policies and significant estimates have not changed substantially from those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2012, as amended.

Fair Value of Financial Instruments

We use the Black-Scholes model to determine the fair value of certain common stock warrants and stock options not yet issued on a recurring basis, and classify such warrants and options as Level 3 in the fair value hierarchy. The Black-Scholes model utilizes inputs consisting of: (i) the closing price of our common stock; (ii) the expected remaining life; (iii) the expected volatility using a weighted average of historical volatilities of CBLI and a group of comparable companies; and (iv) the risk-free market rate.

 
15

 
 
As of September 30, 2013, we held approximately $3.6 million in accrued expenses primarily related to warrants to purchase common stock, which we classified as Level 3.

Three Months Ended September 30, 2013 Compared to Three Months Ended September 30, 2012
 
Revenue
 
Revenue increased from $0.2 million for the three months ended September 30, 2012 to $1.6 million for the three months ended September 30, 2013, representing an increase of $1.4 million, or 645%. This increase was primarily related to increases of $0.7 million related to our Russian grants and contracts and $0.7 million from our contracts with the U.S. Department of Defense (“DoD”). The revenues related to our contracts and grants and differences between the periods are set forth in the following table:

       
Three Months Ended September 30,
       
Funding Source
 
Program
 
2013
   
2012
   
Variance
 
 
                     
DoD
 
CBMS-MITS Contract
  $ 642,340     $ 50,885     $ 591,455  
Russian Federation Ministry of Industry & Trade
 
CBLB612 Pre-clinical (1)
    214,433       88,752       125,681  
DoD
 
DTRA Contract
    144,344       -       144,344  
          1,001,117       139,637       861,480  
Skolkovo Foundation
 
Curaxin research (1)
    367,336       79,938       287,398  
Russian Federation Ministry of Industry & Trade
 
Xenomycins Pre-clinical (1)
    267,147       -       267,147  
                             
 
      $ 1,635,600     $ 219,575     $ 1,416,025  
 
(1)
The grants received from Russian government entities are denominated in Russian Rubles (RUB). The revenue above was calculated using average exchange rates for the periods presented.
 
We anticipate our revenue over the next year will continue to be derived mainly from government grants and contracts. We plan to submit or have submitted proposals for government grants and contracts to funding sources that have awarded us grants and contracts in the past, but there can be no assurance that we will receive future funding awards. The following table sets forth information regarding our currently active grants and contracts: 
 
                   
As of September 30, 2013
 
Funding Source
 
Program
 
Total Award
Value
   
Funded
Award Value
   
Cumulative Revenue
Recognized
   
Funded
Backlog
 
 
                           
DoD
 
CBMS-MITS Contract (1)
  $ 48,322,695     $ 6,933,761     $ 6,735,732     $ 198,029  
Russian Federation Ministry of Industry & Trade
 
CBLB612 Pre-clinical (2)
    4,354,362       2,987,849       1,765,908       1,221,941  
DoD
 
DTRA Contract
    2,359,548       2,359,548       2,103,565       255,983  
          55,036,605       12,281,158       10,605,205       1,675,953  
Russian Federation Ministry of Industry & Trade
 
Xenomycins Pre-clinical (2)
    4,590,052       3,399,763       1,591,143       1,808,620  
Skolkovo Foundation
 
Curaxin research (2)
    4,724,268       4,724,268       2,849,914       1,874,354  
                                     
 
      $ 64,350,925     $ 20,405,189     $ 15,046,262     $ 5,358,927  
 
(1)
Includes a $30 million conditional purchase options for up to 37,500 doses of Entolimod as a radiation countermeasure, exercisable upon approval.
(2)
The contracts received from Russian government entities are denominated in Russian Rubles (RUB). The contract value above is calculated based on the cumulative revenue recognized to date plus our backlog valued at the September 30, 2013 exchange rate.
 
Not reflected in the tables above are two matching-fund development contracts that were awarded in October 2013 totaling approximately $9.2 million in award value. The first contract was received by our wholly-owned subsidiary, BioLab 612, and will be used to support the clinical safety and efficacy assessment of Entolimod as an anti-cancer adjuvant therapy in colorectal cancer patients. The second contract was received by Panacela and will support the preclinical and clinical studies for Mobilan, an anti-cancer vaccine. These contracts were received from the Ministry of Industry and Trade of the Russian Federation and are valued at 149 million rubles ($4.6 million) each.

 
16

 
 
Research and Development Expenses
 
Research and development (“R&D”) expenses decreased from $4.8 million for the three months ended September 30, 2012 to $4.2 million for the three months ended September 30, 2013, representing a decrease of $0.6 million, or 13%. This net decrease primarily reflected a decrease of $0.9 million at Panacela related to a shift toward the development of two lead compounds, Xenomycins and Mobilan.  This decrease was partially offset by an increase of $0.3 million related to our Curaxin compounds due to our recently initiated clinical trial in the United States and our ongoing clinical study in Russia, both for the CBL0137 drug candidate. The following table sets forth our R&D expenses by drug candidate:
 
   
Three Months Ended September 30,
       
   
2013
   
2012
   
Variance
 
                   
 Entolimod for Biodefense Applications
  $ 2,333,946     $ 2,369,959     $ (36,013 )
 CBLB612
    223,781       178,736       45,045  
 Entolimod for Oncology Applications
    122,472       91,633       30,839  
      2,680,199       2,640,328       39,871  
 Curaxins
    951,472       665,654       285,818  
 Panacela product candidates
    573,567       1,535,342       (961,775 )
                         
Total research & development expenses
  $ 4,205,238     $ 4,841,324     $ (636,086 )
 
General and Administrative Expenses
 
General and administrative (“G&A”) costs increased from $3.2 million for the three months ended September 30, 2012 to $3.3 million for the three months ended September 30, 2013, representing an increase of $0.1 million, or 2%. This net increase was due to increases of $0.5 million related to the G&A functions of our Russian-based subsidiaries and $0.1 million in corporate legal and intellectual property costs.  These increases were partially offset by decreases of $0.3 million in business development costs and $0.2 million in stock based compensation.
 
Other Income and Expenses
 
Other income (expense) decreased from $4.5 million of other expense for the three months ended September 30, 2012 to $1.2 million of other income for the three months ended September 30, 2013, representing a decrease of $5.7 million, or 128%. This net decrease was primarily attributable to decreases of $5.6 million in the change in the value of our warrant liability and $0.2 million in foreign exchange losses. These cost decreases were offset by a decrease in interest and other income of $0.1 million.
 
Nine Months Ended September 30, 2013 Compared to Nine Months Ended September 30, 2012
 
Revenue
 
Revenue increased from $1.4 million for the nine months ended September 30, 2012 to $4.6 million for the nine months ended September 30, 2013, representing an increase of $3.2 million, or 228%. This increase was primarily related to increases of $2.6 million related to our Russian grants and contracts and $0.6 million from our contracts with the DoD. The revenues related to our contracts and grants and differences between the periods are set forth in the following table:
 
 
17

 
 
       
Nine Months Ended September 30,
       
Funding Source
 
Program
 
2013
   
2012
   
Variance
 
 
                     
DoD
 
CBMS-MITS Contract
  $ 1,313,784     $ 1,113,830     $ 199,954  
Russian Federation Ministry of Industry & Trade
 
CBLB612 Pre-clinical (1)
    877,222       88,752       788,470  
DoD
 
DTRA Contract
    511,000       126,689       384,311  
          2,702,006       1,329,271       1,372,735  
Skolkovo Foundation
 
Curaxin research (1)
    1,272,449       79,938       1,192,511  
Russian Federation Ministry of Industry & Trade
 
Xenomycins Pre-clinical (1)
    641,879       -       641,879  
                             
 
      $ 4,616,334     $ 1,409,209     $ 3,207,125  
 
(1)
The grants received from Russian government entities are denominated in Russian Rubles (RUB). The revenue above was calculated using average exchange rates for the periods presented.
 
Research and Development Expenses
 
R&D expenses decreased from $16.9 million for the nine months ended September 30, 2012 to $14.9 million for the nine months ended September 30, 2013, representing a decrease of $2.0 million, or 12%. This net decrease primarily reflected decreases of $2.4 million for Entolimod for Biodefense applications as we worked towards the completion of a pivotal NHP study during the nine months ended September 30, 2012, $1.3 million related to our Panacela product candidates and $0.1 million related to Entolimod for Oncology applications. These decreases were partially offset by increases of $1.5 million in costs related to Curaxin compounds due to our recently initiated clinical trial in the United States and our ongoing clinical study in Russia, both for the CBL0137 drug candidate, and $0.3 million to prepare CBLB612’s dossier of information for an IND filing in Russia. The following table sets forth our R&D expenses by drug candidate:
 
   
Nine Months Ended September 30,
       
   
2013
   
2012
   
Variance
 
                   
Entolimod for Biodefense Applications
  $ 7,384,265     $ 9,787,546     $ (2,403,281 )
CBLB612
    1,011,794       738,389       273,405  
Entolimod for Oncology Applications
    373,302       488,616       (115,314 )
      8,769,361       11,014,551       (2,245,190 )
Curaxins
    3,647,963       2,104,953       1,543,010  
Panacela product candidates
    2,492,558       3,800,896       (1,308,338 )
                         
Total research & development expenses
  $ 14,909,882     $ 16,920,400     $ (2,010,518 )
 
General and Administrative Expenses
 
General and administrative costs increased from $9.0 million for the nine months ended September 30, 2012 to $9.8 million for the nine months ended September 30, 2013, representing an increase of $0.8 million, or 9%. This net increase was primarily attributable to increases of $0.7 million related to our Russian-based subsidiaries including BioLabs 612 which was not operational in 2012 and $0.6 million in corporate legal and intellectual property fees. These increases were partially offset by decreases of $0.5 million in business development expenses.
 
Other Income and Expenses

Other income (expense) decreased from $0.1 million of other expense for the nine months ended September 30, 2012 to $0.8 million of other income for the nine months ended September 30, 2013, representing a decrease of $0.9 million, or 684%. This net decrease was primarily due to a decrease of $0.6 million in the change in the value of our warrant liability primarily driven by the change in the fair market value of our stock, and an increase of $0.4 million in foreign exchange gains. These cost changes were partially offset by a decrease in interest and other income of $0.1 million.

Liquidity and Capital Resources

We have incurred net losses of $135.2 million since inception through September 30, 2013. Historically, we have not generated, and do not expect to generate, revenue from sales of product candidates in the immediate future. Since our founding in 2003, we have funded our operations through a variety of means:
 
 
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Since our inception in 2003, we have raised $107.8 million of net equity capital, including amounts received from the exercise of options and warrants. We have also received $5.8 million in net proceeds from the issuance of long-term debt instruments.
The U.S. Department of Defense and Department of Health and Human Services awarded grants and contracts totaling $85.9 million for the development of Entolimod as a radiation countermeasure, including purchase options totaling $30 million for the purchase of up to 37,500 doses of Entolimod, which is exercisable upon funding and FDA approval. Of the total amount awarded, we earned $44.1 million through September 30, 2013 and expect to earn $0.5 million during the remainder of 2013. These contracts expire at term in December 2013 which is particularly relevant for the $30 million purchase option.  Management is currently working to pursue extensions of these contracts.
Entities affiliated with the Russian Federation have awarded us contracts totaling $13.7 million, including awards for the development of Curaxins ($4.6 million), CBLB612 ($4.4 million) and Xenomycins ($4.7 million). All awards are valued based on revenue recognized to date, with the remaining backlog valued at the September 30, 2013 exchange rate. These contracts include a requirement for us to contribute matching funds, which are satisfied with both the value of developed intellectual property at the time of award and future expenses. At September 30, 2013, $11.1 million of the awards were funded; $8.1 million was received, of which $2.0 million remains as deferred revenue. We expect to recognize the remaining funding in 2013 and 2014. In addition to these contracts, in October 2013 we were awarded two contracts from the Ministry of Industry and Trade of the Russian Federation. Each of these contracts was valued at 149 million rubles ($4.6 million) each, of which each was funded by $3.4 million, giving us an additional $6.8 million in funding. We expect to recognize this funding over a period of performance beginning in October 2013 and ending in December 2015.
We have been awarded $4.0 million in grant and contracts not described above, all of which has been recognized at September 30, 2013.
We actively pursue all reasonable domestic and international sources of grant and contract funding for our drug pipeline.
Incuron was formed to develop and commercialize our Curaxin product line, namely two compounds CBL0102 and CBL0137. BioProcess Capital Partners (“BCP”) committed to contribute up to $17.3 million (based on the current exchange rate) of funding as development milestones were accomplished. To date, Incuron has received $11.7 million of funding from BCP. BCP’s remaining capital contribution of $5.6 million is due upon completion of certain developmental milestones which the Company believes will occur in 2013.
Panacela was formed to develop and commercialize five preclinical compounds. Open Joint Stock Company “Rusnano” contributed $9.0 million at formation, a $1.5 million convertible loan and has options to contribute up to $15.5 million of additional funding as development milestones are accomplished. CBLI contributed $3.0 million plus intellectual property at formation and has options to contribute additional capital based on agreed-upon terms.
 
At September 30, 2013, we had cash, cash equivalents and short-term investments of $14.6 million. Of that total, $3.8 million was restricted for the use of our majority-owned subsidiaries, leaving $10.8 million available for general use. Furthermore, Panacela had $2.9 million of restricted cash held for performance bonds in connection with the Xenomycins and Mobilan contracts, which is classified as a long-term asset.
 
Operating Activities
 
Net cash used in operations increased by $3.4 million to $18.9 million for the nine months ended September 30, 2013 from $15.5 million for the nine months ended September 30, 2012. After adjusting for non-cash items, the net loss decreased by $3.8 million, while changes in working capital used cash and cash equivalents of $7.2 million between the periods.
 
Investing Activities
 
Net cash provided by investing activities was $0.6 million for the nine months ended September 30, 2013, compared to net cash used in investing activities of $1.5 million for the nine months ended September 30, 2012, representing an increase of $2.1 million between the periods. This net increase was due to an increase of $3.5 million related to the management of our cash and short-term investments, and was partially offset by the reclassification of $1.4 million of cash to restricted cash for the nine months ended September 30, 2013.

Financing Activities
 
Cash flows provided by financing activities increased by $1.4 million for the nine months ended September 30, 2013 as compared to the nine months ended September 30, 2012. Cash flows provided by financing activities was $7.3 million for the nine months ended September 30, 2013, primarily attributable to the $5.8 million in net proceeds from CBLI’s closing of the Hercules loan and $1.5 million from Panacela’s closing of the Rusnano loan. Cash flows provided by financing activities for the nine months ended September 30, 2012 was $5.9 million, which was primarily attributable to a capital contribution by BCP to Incuron.
 
 
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Other
 
We have incurred cumulative net losses and expect to incur additional losses related to our research and development activities. We do not have commercial products and have limited capital resources. We will need additional funds to complete the development of our products. Our plans with regard to these matters may include seeking additional capital through a combination of government contracts, collaborative agreements, strategic alliances, research grants and future equity and debt financing. Although we continue to pursue these plans, there is no assurance that we will be successful in obtaining future financing on commercially reasonable terms or that we will be able to secure funding from anticipated government contracts and grants.

We submitted a proposal to Biomedical Advanced Research and Development Agency (“BARDA”) for the continued development of Entolimod as a radiation countermeasure. If awarded in full, we anticipate that this contract could fund all remaining work necessary to complete development of Entolimod as a radiation countermeasure and allow us to file a Biologic License Application (“BLA”) with the FDA.  There can be no assurance that the proposal for the BARDA funding will be granted, and if granted, when such award will be made.

We believe that our existing funds combined with cash flows from existing government grants and contracts will be sufficient to fund our projected operating requirements into the second quarter of 2014, based upon current operating plans and spending assumptions, limited to existing contracts in place. Our success is dependent upon commercializing our research and development programs and our ability to obtain adequate future financing. There can be no assurance that we will be able to obtain future financing or, if obtained, what the terms of such future financing may be, or that any amount that we are able to obtain will be adequate to support our working capital requirements until we achieve profitable operations. If we are unable to raise adequate capital and/or achieve profitable operations, future operations might need to be scaled back or discontinued. The financial statements do not include any adjustments relating to the recoverability of the carrying amount of recorded assets and liabilities that might result from the outcome of these uncertainties.

Impact of Inflation

We believe that our results of operations are not dependent upon moderate changes in inflation rates.

Impact of Exchange Rate Fluctuations

From time-to-time, our operations are somewhat dependent upon changes in foreign currency exchange rates, however at September 30, 2013, our foreign currency obligations were not material.

Off-Balance Sheet Arrangements

We have not entered into any off-balance sheet arrangements.
 

There has been no significant change in our exposure to market risk during the first nine months of 2013. For a discussion of our exposure to market risk, refer to Part II, Item 7A, “Quantitative and Qualitative Disclosures About Market Risk,” contained in our Annual Report on Form 10-K for the year ended December 31, 2012, as amended.


Effectiveness of Disclosure

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act as of September 30, 2013. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of September 30, 2013, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective to assure that information required to be declared by us in reports that we file or submit under the Exchange Act is (1) recorded, processed, summarized, and reported within the periods specified in the SEC’s rules and forms and (2) accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
 
Changes in Internal Control over Financial Reporting
 
There was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15(d)-15(f) under the Exchange Act) during the fiscal quarter ended September 30, 2013, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
 
 
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PART II - Other Information


As of September 30, 2013, we were not a party to any litigation or other legal proceeding.

 
We have marked with an asterisk those risk factors that reflect material changes from the risk factors previously discussed in our Form 10-K for the year ended December 31, 2012, as amended.

RISKS RELATED TO OUR FINANCIAL CONDITION AND NEED FOR ADDITIONAL CAPITAL

* We have a history of operating losses. We expect to continue to incur losses and may not continue as a going concern.

We have incurred net losses of approximately $16.9 million and $135.2 million for the nine months ended September 30, 2013 and since inception, respectively. We expect significant losses to continue for the next few years as we spend substantial additional sums on the continued R&D of our proprietary product candidates, and there is no certainty that we will ever become profitable as a result of these expenditures. As a result of losses that will continue throughout our development stage, we may exhaust our financial resources and be unable to complete the development of our product candidates.

Our ability to become profitable depends primarily on the following factors:

our ability to obtain adequate sources of continued financing;
our ability to obtain approval for, and if approved, to successfully commercialize, Entolimod;
our ability to bring to market other proprietary drugs that are progressing through our development process;
our R&D efforts, including the timing and cost of clinical trials; and
our ability to enter into favorable alliances with third-parties who can provide substantial capabilities in clinical development, manufacturing, regulatory affairs, sales, marketing and distribution.

Even if we successfully develop and market our product candidates, we may not generate sufficient or sustainable revenue to achieve or sustain profitability.

We will require substantial additional financing in order to meet our business objectives.

We are and will continue to be dependent on our ability to raise money through the issuance of additional equity or debt securities, or by entering into other financial arrangements, including relationships with corporate and other partners, in order to cover our operational costs, including the costs of product development and clinical testing.

Depending upon market conditions and subject to limitations imposed by the terms of our outstanding securities and contractual obligations, we may not be successful in raising sufficient additional capital for our long-term requirements. In addition, the decline in the market price of our common stock could make it more difficult for us to sell equity or equity-related securities in the future at a time and price that we deem appropriate. Our internal sources of liquidity may prove to be insufficient, and in such case, we may not be able to successfully obtain financing on favorable terms, or at all. If we fail to raise sufficient additional financing and on terms and dates acceptable to us, we may not be able to continue our operations and the development of our product candidates, and may be required to reduce staff, reduce or eliminate R&D, slow the development of our product candidates, outsource or eliminate several business functions or shut down operations. Even if we are successful in raising such additional financing, we may not be able to successfully complete pre-clinical studies or clinical trials, development, and marketing of all, or of any, of our product candidates. Additionally, funds raised through debt financing would require us to make periodic payments of interest and principal and might impose restrictive covenants on the conduct of our business. Furthermore, any funds raised through collaboration and licensing arrangements with third parties may require us to relinquish valuable rights to our technologies or product candidates, or grant licenses on terms that are not favorable to us. In any such event, our business, prospects, financial condition and results of operations could be materially adversely affected.

 
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*Covenants in our loan agreement with Hercules restrict our financial and operational flexibility.
 
On September 30, 2013, we entered into a Loan and Security Agreement with Hercules under which we are subject to certain covenants that restrict our financial and operational flexibility. For example, we are restricted from incurring additional indebtedness, redeeming or declaring or paying any cash dividends or cash distributions on our common stock, or transferring any material portion of our assets. As a result of these covenants, our ability to finance our operations through the incurrence of additional debt or the sale of assets is limited.

Our R&D expenses are subject to uncertainty.

We are highly dependent on the success of our R&D efforts and, ultimately, upon regulatory approval and market acceptance of our products under development. Our ability to complete our R&D on schedule is, however, subject to a number of risks and uncertainties. Because we expect to expend substantial resources on R&D, our success depends in large part on the results as well as the costs of our R&D. R&D expenditures are uncertain and subject to much fluctuation. Factors affecting our R&D expenses include, but are not limited to:

the number and outcome of pre-clinical studies and clinical trials we are planning to conduct; for example, our R&D expenses may increase based on the number of pivotal animal studies and clinical trials that we may be required to conduct;
the number of products entering into development from late-stage research; for example, there is no guarantee that internal research efforts will succeed in generating sufficient data for us to make a positive development decision or that an external drug candidate will be available on terms acceptable to us and some promising product candidates may not yield sufficiently positive pre-clinical results to meet our stringent development criteria;
in-licensing activities, including the timing and amount of related development funding or milestone payments; for example, we may enter into agreements requiring us to pay a significant up-front fee for the purchase of in-process R&D that we may record as R&D expense; or
future levels of revenue; R&D expenses as a percentage of future potential revenues can fluctuate with the changes in future levels of revenue and lower revenues can lead to less spending on R&D efforts.

Our ability to use our net operating loss carryforwards may be limited.

As of December 31, 2012, we had federal net operating loss carryforwards, or NOLs, of $94.1 million to offset future taxable income, which expire if not utilized by 2023. Under the provisions of the Internal Revenue Code, substantial changes in our ownership, in certain circumstances, will limit the amount of NOLs that can be utilized annually in the future to offset taxable income. In particular, section 382 of the Internal Revenue Code imposed limitations on a company’s ability to use NOLs if a company experiences a more than 50% ownership change over a three-year period. If we are limited in our ability to use our NOLs in future years in which we have taxable income, we will pay more taxes than if we were able to utilize our NOLs fully.
 
RISKS RELATED TO PRODUCT DEVELOPMENT

We may not be able to successfully and timely develop our products.

Our product candidates range from ones currently in the research stage to ones currently in the clinical stage of development and all require further testing to determine their technical and commercial viability. Our success will depend on our ability to achieve scientific and technological advances and to translate such advances into reliable, commercially competitive products on a timely basis. In addition, the success of our subsidiaries will depend on their ability to meet developmental milestones in a timely manner, which are pre-requisites to their receipt of additional funding under their government contracts and/or from their non-controlling interest holders. Products that we may develop are not likely to be commercially available for several years. The proposed development schedules for our products may be affected by a variety of factors, including, among others, technological difficulties, proprietary technology of others, the government approval process, the availability of funds and changes in government regulation, many of which will not be within our control. Any delay in the development, introduction or marketing of our products could result either in such products being marketed at a time when their cost and performance characteristics would not be competitive in the marketplace or in the shortening of their commercial lives. In light of the long-term nature of our projects and the unproven technology involved, we may not be able to complete successfully the development or marketing of any products.
 
We may fail to develop and commercialize our products successfully or in a timely manner because:

pre-clinical study or clinical trial results may show the product to be less effective than desired (e.g., the study failed to meet its primary objectives) or to have harmful or problematic side effects;
we fail to receive the necessary regulatory approvals or there is a delay in receiving such approvals. Among other things, such delays may be caused by slow enrollment in clinical studies, length of time to achieve study endpoints, additional time requirements for data analysis or an NDA or BLA preparation, discussions with the FDA, an FDA request for additional pre-clinical or clinical data or unexpected safety or manufacturing issues;
they fail to conform to a changing standard of care for the diseases they seek to treat;
they are less effective or more expensive than current or alternative treatment methods;
 
 
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of manufacturing costs, pricing or reimbursement issues, or other factors that make the product not economically feasible; or
proprietary rights of others and their competing products and technologies may prevent our product from being commercialized.

Our collaborative relationships with third parties could cause us to expend significant resources and incur substantial business risk with no assurance of financial return.

We anticipate substantial reliance upon strategic collaborations for marketing and commercialization of our product candidates and we may rely even more on strategic collaborations for R&D of our other product candidates. Our business depends on our ability to sell drugs to both government agencies and to the general pharmaceutical market. Offering our product candidates for anti-radiation applications to government agencies does not require us to develop new sales, marketing or distribution capabilities beyond those already existing in the company. Selling oncology and anti-infective drugs, however, requires a more significant infrastructure. We plan to sell oncology and anti-infective drugs through strategic partnerships with pharmaceutical companies. If we are unable to establish or manage such strategic collaborations on terms favorable to us in the future, our revenue and drug development may be limited. To date, we have not entered into any strategic collaborations with third parties capable of providing these services. In addition, we have not yet marketed or sold any of our product candidates or entered into successful collaborations for these services in order to ultimately commercialize our product candidates. We also rely on third-party collaborations with our manufacturers. Manufacturers producing our product candidates must follow current Good Manufacturing Practice (“cGMP”) regulations enforced by the FDA and foreign equivalents.

Establishing strategic collaborations is difficult and time-consuming. Our discussion with potential collaborators may not lead to the establishment of collaborations on favorable terms, if at all. Potential collaborators may reject collaborations based upon their assessment of our financial, regulatory or intellectual property position. Even if we successfully establish new collaborations, these relationships may never result in the successful development or commercialization of our product candidates or the generation of sales revenue. In addition to the extent that we enter into collaborative arrangements, our drug revenues are likely to be lower than if we directly marketed and sold any drugs that we may develop.

We will not be able to commercialize our product candidates if our pre-clinical development efforts are not successful, our clinical trials do not demonstrate safety or our clinical trials or animal studies do not demonstrate efficacy.
 
Before obtaining required regulatory approvals for the commercial sale of any of our product candidates, we must conduct extensive pre-clinical testing and clinical trials to demonstrate that our product candidates are safe and clinical or animal trials to demonstrate the efficacy of our product candidates. Pre-clinical and clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome. Success in pre-clinical testing and early clinical trials does not ensure that later clinical trials or animal efficacy studies will be successful and interim results of a clinical trial or animal efficacy study does not necessarily predict final results. In addition, we must outsource our clinical trials and majority of our animal studies required to obtain regulatory approval of our products. We are not certain that we will successfully or promptly finalize agreements for the conduct of these studies. Delay in finalizing such agreements would delay the commencement of our pre-clinical and clinical studies, such as animal efficacy studies for Entolimod for biodefense applications and clinical trials of Entolimod, CBL0102 and CBL0137 for oncology applications. In addition, we are seeking FDA agreement on the scope and design of our pivotal animal, human safety and animal-to-human dose conversion programs for Entolimod for biodefense applications. Delay in agreement with the FDA on this program will delay the commercialization of this product.

Agreements with contract research organizations (“CROs”) and study investigators, for clinical or animal testing and with other third parties for data management services place substantial responsibilities on these parties, which could result in delays in, or termination of, our clinical trials if these parties fail to perform as expected. For example, if any of our clinical trial sites fail to comply with Good Clinical Practices or our pivotal animal studies fail to comply with Good Laboratory Practices (“GLP”), we may be unable to use the data generated at those sites. In these studies, if contracted CROs or other third parties do not carry out their contractual duties or obligations or fail to meet expected deadlines, or if the quality or accuracy of the data they obtain is compromised due to their failure to adhere to our protocols or for other reasons, our clinical or animal studies may be extended, delayed or terminated, and we may be unable to obtain regulatory approval for or successfully commercialize Entolimod or other product candidates.

Our clinical trial operations are subject to regulatory inspections at any time. If regulatory inspectors conclude that we or our clinical trial sites are not in compliance with applicable regulatory requirements for conducting clinical trials, we or they may receive warning letters or other correspondence detailing deficiencies and we will be required to implement corrective actions. If regulatory agencies deem our responses to be inadequate, or are dissatisfied with the corrective actions that we or our clinical trial sites have implemented, our clinical trials may be temporarily or permanently discontinued, we may be fined, we or our investigators may be the subject of an enforcement action, the government may refuse to approve our marketing applications or allow us to manufacture or market our products or we may be criminally prosecuted.

 
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In addition, a failure of one or more of our clinical trials or animal studies can occur at any stage of testing and such failure could have a material adverse effect on our ability to generate revenue and could require us to reduce the scope of or discontinue our operations. We may experience numerous unforeseen events during, or as a result of, pre-clinical testing and the clinical trial or animal study process that could delay or prevent our ability to receive regulatory approval or commercialize our product candidates, including:

regulators or institutional review boards (“IRB”) may not authorize us to commence a clinical trial or conduct a clinical trial at a prospective trial site or an institutional animal care and use committee may not authorize us to commence an animal study at a prospective study site;
we may decide, or regulators may require us, to conduct additional pre-clinical testing or clinical trials, or we may abandon projects that we expect to be promising, if our pre-clinical tests, clinical trials or animal efficacy studies produce negative or inconclusive results;
we might have to suspend or terminate our clinical trials if the participants are being exposed to unacceptable safety risks;
regulators or IRBs may require that we hold, suspend or terminate clinical development for various reasons, including noncompliance with regulatory requirements or if it is believed that the clinical trials present an unacceptable safety risk to the patients enrolled in our clinical trials;
the cost of our clinical trials or animal studies could escalate and become cost prohibitive;
any regulatory approval we ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the product not commercially viable;
we may not be successful in recruiting a sufficient number of qualifying subjects for our clinical trials or certain animals used in our animal studies or facilities conducting our studies may not be available at the time that we plan to initiate a study; and
the effects of our product candidates may not be the desired effects, may include undesirable side effects, or the product candidates may have other unexpected characteristics.
 
Even if we or our collaborators complete our animal studies and clinical trials and receive regulatory approval, it is possible that a product may be found to be ineffective or unsafe due to conditions or facts that arise after development has been completed and regulatory approvals have been obtained. In this event, we may be required to withdraw such product from the market. To the extent that our success will depend on any regulatory approvals from government authorities outside of the U.S. that perform roles similar to that of the FDA, uncertainties similar to those stated above will also exist.

* Our majority-owned subsidiaries have significant non-controlling interest holders and, as such, are not operated solely for our benefit.

As of September 30, 2013, we owned 59.2% of the equity interests in Incuron and 54.6% of the equity interests in Panacela. Although these subsidiaries are majority-owned by us and are consolidated in our results, they have significant non-controlling interest holders, each of which are funds regulated by the Russian Federation government. As such, we share ownership and management of our subsidiaries with one or more parties who may not have the same goals, strategies, priorities, or resources as we do.
 
In each of our majority-owned subsidiaries, both we and our co-owners have certain rights in respect of such subsidiaries. Our majority-owned subsidiaries provide the right to each party to designate certain of the board members and certain decisions in respect of these subsidiaries may not be made without a supermajority vote of the equity holders or the consent of all of the equity holders. The right to transfer ownership interests in our majority-owned subsidiaries is restricted by provisions such as rights of first refusal and tag along and drag along rights. In addition, the use of funds and other matters are subject to monitoring and oversight by both groups of equity holders. Furthermore, we are required to pay more attention to our relationship with our co-owners as well as with the subsidiary, and if a co-owner changes, our relationship may be materially adversely affected.
 
The co-owners of our majority-owned subsidiaries have the option to make additional payments to the subsidiaries to finance their operations. Such additional contributions by Bioprocess into Incuron are dependent on the satisfaction of various developmental milestones by Incuron. Due to a recent amendment of the Investment Agreement with Rusnano, additional investments into Panacela by Rusnano are no longer tied to milestones and may now be made at any time at Rusnano’s discretion. As of September 30, 2013, Incuron and Panacela were potentially entitled to $5.6 million and $15.5 million of future milestone-based payments, respectively (in the case of Incuron, based on an exchange rate of $32.3451 Rubles/USD as of September 30, 2013). The failure to satisfy the contractual requirements that we have with our co-owners in respect of obtaining additional financing from them may result in a material adverse effect in our business, financial condition and results of operations.
 
These various restrictions may lead to additional organizational formalities as well as time-consuming procedures for sharing information and making decisions. In addition, the benefits from a successful joint venture are shared among the co-owners, so that we would not receive all the benefits from our successful joint ventures.
 
 
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* If parties on whom we rely to manufacture our product candidates do not manufacture them in satisfactory quality, in a timely manner, in sufficient quantities or at an acceptable cost, clinical development and commercialization of our product candidates could be delayed.

We do not own or operate manufacturing facilities. Consequently, we rely on third parties as sole suppliers of our product candidates. We do not expect to establish our own manufacturing facilities and we will continue to rely on third-party manufacturers to produce clinical supplies and commercial quantities of any products or product candidates that we market or may supply to our collaborators. Our dependence on third parties for the manufacture of our product candidates may adversely affect our ability to develop and commercialize any product candidates on a timely and competitive basis.

To date, our product candidates have only been manufactured in quantities sufficient for pre-clinical studies and clinical trials. We rely on one collaborator to produce Entolimod, one collaborator to produce CBL0102, one collaborator to produce CBL0137, one collaborator to produce CBLB612 and one collaborator to produce Mobilan, two collaborators to produce Xenomycins, and we do not have any collaborative manufacturing agreements for our other product candidates. For a variety of reasons, dependence on any single manufacturer may adversely affect our ability to develop and commercialize our product candidates on a timely and competitive basis. In addition, our current contractual arrangements alone may not be sufficient to guarantee that we will be able to procure the needed supplies as we complete clinical development and/or enter commercialization.

Additionally, in connection with our application for commercial approvals and if any product candidate is approved by the FDA or other regulatory agencies for commercial sale, we will need to procure commercial quantities from qualified third-party manufacturers. We may not be able to contract for increased manufacturing capacity for any of our product candidates in a timely or economic manner or at all. A significant scale-up in manufacturing may require additional validation studies and commensurate financial investments by the contract manufacturers. If we are unable to successfully increase the manufacturing capacity for a product candidate, the regulatory approval or commercial launch of that product candidate may be delayed or there may be a shortage of supply, which could limit our sales and could initiate regulatory intervention to minimize the public health risk.

Other risks associated with our reliance on contract manufacturers include the following:

Contract manufacturers may encounter difficulties in achieving volume production, quality control and quality assurance and also may experience shortages in qualified personnel and obtaining active ingredients for our product candidates.
If, for any circumstance, we are required to change manufacturers, we could be faced with significant monetary and lost opportunity costs with switching manufacturers. Furthermore, such change may take a significant amount of time. The FDA and foreign regulatory agencies must approve these manufacturers in advance. This requires prior approval of regulatory submissions as well as successful completion of pre-approval inspections to ensure compliance with FDA and foreign regulations and standards.
Contract manufacturers are subject to ongoing periodic, unannounced inspection by the FDA and state and foreign agencies or their designees to ensure strict compliance with cGMP and other governmental regulations and corresponding foreign standards. We do not have control over compliance by our contract manufacturers with these regulations and standards. Our contract manufacturers may not be able to comply with cGMP and other FDA requirements or other regulatory requirements outside the U.S. Failure of contract manufacturers to comply with applicable regulations could result in delays, suspensions or withdrawal of approvals, seizures or recalls of product candidates and operating restrictions, any of which could significantly and adversely affect our business.
Contract manufacturers may breach the manufacturing agreements that we have with them because of factors beyond our control or may terminate or fail to renew a manufacturing agreement based on their own business priorities at a time that is costly or inconvenient to us.

Changes to the manufacturing process during the conduct of clinical trials or after marketing approval also require regulatory submissions and the demonstration to the FDA or other regulatory authorities that the product manufactured under the new conditions complies with cGMP requirements. These requirements especially apply to moving manufacturing functions to another facility. In each phase of investigation, sufficient information about changes in the manufacturing process must be submitted to the regulatory authorities and may require prior approval before implementation with the potential of substantial delay or the inability to implement the requested changes.
 
RISKS RELATING TO REGULATORY APPROVAL

We may not be able to obtain regulatory approval in a timely manner or at all and the results of clinical trials may not be favorable.

The testing, marketing and manufacturing of any product for use in the U.S. will require approval from the FDA. We cannot predict with any certainty the amount of time necessary to obtain FDA approval and whether any such approval will ultimately be granted. Pre-clinical studies and clinical trials may reveal that one or more products are ineffective or unsafe, in which event, further development of such products could be seriously delayed, terminated or rendered more expensive. Moreover, obtaining approval for certain products may require testing on human subjects of substances whose effects on humans are not fully understood or documented.

 
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In addition, we expect to rely on an FDA regulation known as the “Animal Rule” to obtain approval for Entolimod for biodefense applications. The Animal Rule permits the use of animal efficacy studies together with human clinical safety and immunogenicity trials to support an application for marketing approval of products when human efficacy studies are neither ethical nor feasible. These regulations are relatively new and we have limited experience in the application of these rules to the product candidates that we are developing. In fact, to date no new pharmaceuticals have been approved under the Animal Rule. As such the FDA is setting rule-making precedent given our advanced stage of development and, consequently, we cannot predict the time required for them to confirm the relevant rules, or the scope thereof. The FDA may decide that our data are insufficient for approval and require additional pre-clinical, clinical or other studies, refuse to approve our products, or place restrictions on our ability to commercialize those products. If we are not successful in completing the development, licensure and commercialization of Entolimod for biodefense applications, or if we are significantly delayed in doing so, our business will be materially harmed.
 
The receipt of FDA approval may be delayed for reasons other than the results of pre-clinical studies and clinical trials. For example, in 2011, the IND application for Entolimod for biodefense applications was transferred within the FDA from the Division of Biologic Oncology Products (“DBOP”) to the Division of Medical Imaging Products (“DMIP”). As a result of this transfer, we requested and participated in seven additional meetings with DMIP during 2011-2012 to review the product mechanisms of action, safety profile and preliminary estimation of an effective human dose. While (i) DMIP has agreed on the scope and design of the proposed pivotal animal efficacy program, acknowledged that specific cytokines do play an important role in Entolimod’s mechanism of action and, as such, can be used as biomarkers for animal-to-human dose conversion, and (ii) gave advice on the design of the remaining clinical program, we are still in the process of reaching an agreement with FDA on the certain elements of the design of our remaining clinical studies for Entolimod and animal-to-human dose conversion. There can be no guarantee that we will reach a satisfactory agreement in a timely manner, or at all, or that DMIP may request any additional information related to our preclinical or clinical programs.
 
Delays in obtaining FDA or any other necessary regulatory approvals of any proposed product or the failure to receive such approvals would have an adverse effect on our ability to develop such product, the product’s potential commercial success and/or on our business, prospects, financial condition and results of operations.

Failure to obtain regulatory approval in international jurisdictions could prevent us from marketing our products abroad.

We intend to market our product candidates, including specifically the product candidates being developed by our subsidiaries, in the U.S., the Russian Federation and other countries and regulatory jurisdictions. In order to market our product candidates in the U.S., Russia and other jurisdictions, we must obtain separate regulatory approvals in each of these countries and territories. The procedures and requirements for obtaining marketing approval vary among countries and regulatory jurisdictions and can involve additional clinical trials or other tests. In addition, we do not have in-house experience and expertise regarding the procedures and requirements for filing for and obtaining marketing approval for drugs in countries outside of the U.S. and Europe and may need to engage and rely upon expertise of third parties when we file for marketing approval in countries outside of the U.S. and Europe. Also, the time required to obtain approval in markets outside of the U.S. may differ from that required to obtain FDA approval, while still including all of the risks associated with obtaining FDA approval. We may not be able to obtain all of the desirable or necessary regulatory approvals on a timely basis, if at all. Approval by a regulatory authority in a particular country or regulatory jurisdiction, such as the FDA in the U.S. or the Roszdravnadzor in Russia, does not ensure approval by a regulatory authority in another country.

We may not be able to file for regulatory approvals and may not receive necessary approvals to commercialize our product candidates in any or all of the countries or regulatory jurisdictions in which we desire to market our product candidates. At this time, other countries do not have an equivalent to the Animal Rule and, as a result, such countries do not have established criteria for review and approval for this type of product outside their normal review process. Specifically, because such other countries do not have an equivalent to the Animal Rule, we may not be able to file for or receive regulatory approvals for Entolimod for biodefense applications outside the U.S. based on our animal efficacy and human safety data.

The Fast Track designation for Entolimod may not actually lead to a faster development or regulatory review or approval process.
 
We have obtained a “Fast Track” designation from the FDA for Entolimod for biodefense applications. However, we may not experience a faster development process, review or approval compared to conventional FDA procedures. The FDA may withdraw our Fast Track designation if the FDA believes that the designation is no longer supported by data from our clinical development program. Our Fast Track designation does not guarantee that we will qualify for or be able to take advantage of the FDA’s expedited review procedures or that any application that we may submit to the FDA for regulatory approval will be accepted for filing or ultimately approved.
 
 
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Even if our drug candidates obtain regulatory approval, we will be subject to ongoing government regulation.

Even if our drug candidates obtain regulatory approval, our products will be subject to continuing regulation by the FDA, including record keeping requirements, submitting periodic reports to the FDA, reporting of any adverse experiences with the product and complying with Risk Evaluation and Mitigation Strategies and drug sampling and distribution requirements. In addition, updated safety and efficacy information must be maintained and provided to the FDA. We or our collaborative partners, if any, must comply with requirements concerning advertising and promotional labeling, including the prohibition against promoting and non-FDA approved or “off-label” indications or products. Failure to comply with these requirements could result in significant enforcement action by the FDA, including warning letters, orders to pull the promotional materials and substantial fines.

After FDA approval of a product, the discovery of problems with a product or its class, or the failure to comply with requirements may result in restrictions on a product, manufacturer, or holder of an approved marketing application. These include withdrawal or recall of the product from the market or other voluntary or FDA-initiated action that could delay or prevent further marketing. Newly discovered or developed safety or effectiveness data, including from other products in a therapeutic class, may require changes to a product’s approved labeling, including the addition of new warnings and contraindications. Also, the FDA may require post-market testing and surveillance to monitor the product’s safety or efficacy, including additional clinical studies, known as Phase 4 trials, to evaluate long-term effects. It is also possible that rare but serious adverse events not seen in our drug candidates may be identified after marketing approval. This could result in withdrawal of our product from the market.

Compliance with post-marketing regulations may be time-consuming and costly and could delay or prevent us from generating revenue from the commercialization of our drug candidates.

If physicians and patients do not accept and use our drugs, we will not achieve sufficient product revenues and our business will suffer.
 
Even if we gain marketing approval of our drug candidates, physicians and patients may not accept and use them. Acceptance and use of these products may depend on a number of factors including:
 
·
perceptions by members of the healthcare community, including physicians, about the safety and effectiveness of our drugs;
·
published studies demonstrating the safety and effectiveness of our drugs;
·
adequate reimbursement for our products from payors; and
·
effectiveness of marketing and distribution efforts by us and our licensees and distributors, if any.

The failure of our drugs, if approved for marketing, to gain acceptance in the market would harm our business and could require us to seek additional financing.

RISKS RELATED TO OUR DEPENDENCE ON U.S. GOVERNMENT CONTRACTS AND GRANTS

* If we lose our funding from R&D contracts and grants, or if we are unable to procure additional government funding, we may not be able to fund future R&D and implement technological improvements, which would materially harm our financial conditions and operating results.

Grant and contract revenue from the United States government accounted for 39.5% and 88% of our revenue for the nine months ended September 30, 2013 and 2012, respectively.

These revenues have funded some of our personnel and other R&D and General and Administrative costs and expenses. However, it is possible that awards that have been granted will not be funded in their entirety, that the funding will be delayed, or that the contracts representing the awards may expire by their terms without funding or procurement options exercised. For example the Company’s Chemical Biological Medical Systems-Medical Identification and Treatment Systems (CBMS-MITS) contract will expire by its terms on December 13, 2013. While the Company is currently in discussions with CBMS-MITS to extend the contract, we may not be successful.  In the event the CBMS-MITS contract is not extended, its unfunded options including a procurement option would expire, and the Company would need to renegotiate a procurement contract with the Department of Defense, likely through a competitive bidding process, for the procurement of Entolimod as a radiation countermeasure.

We may not be able to procure new grants and contracts that will provide sufficient funding, new procurement options, or at all. In addition, the finalization of new contracts and grants may require a significant time from the initial request and negotiations for such contracts and grants are subject to a significant amount of uncertainty.
 
 
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For example, on May 31, 2011, we announced that we had concluded advanced stages of contract negotiation with BARDA for the funding of certain development activities relating to Entolimod for biodefense applications in our 2010 proposal to BARDA. BARDA indicated that further contract-related negotiations will require clarification of the development path for Entolimod for biodefense applications with the FDA, which is in the process of actively reviewing our IND application for Entolimod. BARDA indicated that we may resubmit an updated proposal upon confirmation from the FDA that they do not have any objections to us proceeding with our development plan as a result of this review. We received a confirmatory letter from the FDA in late 2011 and submitted a white paper to BARDA under its currently open Broad Agency Announcement (the “BAA”). On April 4, 2012, we announced that BARDA had declined to invite the Company to submit a full proposal pursuant to the white paper submitted. After further discussions with both the FDA and BARDA, we announced on October 18, 2012, that the Company had submitted a proposal to BARDA under the BAA for the remaining development steps needed for FDA licensure of Entolimod as a medical radiation countermeasure. However, as with any federal contract proposal, there is no assurance that BARDA will make a positive decision with regard to funding our proposal. Additionally, there is no assurance that BARDA will review our proposal or award a contract (if one is awarded) in a timely manner.

If we are unable to obtain sufficient grants and contracts on a timely basis or if our existing grants and contracts are not funded, our ability to fund future R&D would be diminished, which would negatively impact our ability to compete in our industry and could materially and adversely affect our business, financial condition and results of operations.

Our future business may be harmed as a result of the government contracting process as it involves risks not present in the commercial marketplace.
 
We expect that a significant portion of the business that we will seek in the near future will be under government contracts or subcontracts, both U.S. and foreign, which may be awarded through competitive bidding. Competitive bidding for government contracts presents a number of risks that are not typically present in the commercial contracting process, which may include:
 
the need to devote substantial time and attention of management and key employees to the preparation of bids and proposals for contracts that may not be awarded to us;
the need to accurately estimate the resources and cost structure that will be required to perform any contract that we might be awarded;
the risk that the government will issue a request for proposal to which we would not be eligible to respond;
the risk that third parties may submit protests to our responses to requests for proposal that could result in delays or withdrawals of those requests for proposal;
the expenses that we might incur and the delays that we might suffer if our competitors protest or challenge contract awards made to us pursuant to competitive bidding and the risk that any such protest or challenge could result in the resubmission of bids based on modified specifications, or in termination, reduction or modification of the awarded contract; and
the risk that review of our proposal or award of a contract or an option to an existing contract could be significantly delayed for reasons including, but not limited to, the need for us to resubmit our proposal or limitations on available funds due to government budget cuts.
 
The U.S. government may choose to award future contracts for the supply of medical radiation countermeasures to our competitors instead of to us. If we are unable to win particular contracts, or if the government chooses not to fully exercise all options under contracts awarded to us, we may not be able to operate in the market for products that are provided under those contracts for a number of years. If we are unable to consistently win new contract awards and have the options under our existing contracts exercised over an extended period, or if we fail to anticipate all of the costs and resources that will be required to secure such contract awards, our growth strategy and our business, financial condition and operating results could be materially adversely affected.
 
U.S. government agencies have special contracting requirements, which create additional risks.

We have entered into contracts with various U.S. government agencies. For the near future, substantially all of our revenue may be derived from government contracts and grants. In contracting with government agencies, we will be subject to various federal contract requirements. Future sales to U.S. government agencies will depend, in part, on our ability to meet these requirements, certain of which we may not be able to satisfy.

U.S. government contracts typically contain unfavorable termination provisions and are subject to audit and modification by the government at its sole discretion, which subjects us to additional risks. These risks include the ability of the U.S. government to unilaterally:

suspend or prevent us for a set period of time from receiving new contracts or extending existing contracts based on violations or suspected violations of laws or regulations;
terminate our existing contracts;
reduce the scope and value of our existing contracts;
 
 
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audit and object to our contract-related costs and fees, including allocated indirect costs;
control and potentially prohibit the export of our products; and
change certain terms and conditions in our contracts.

Pursuant to our government contracts, we are generally permitted to retain title to any patentable invention or discovery made while performing the contract. However, the U.S. government is generally entitled to receive a non-exclusive, non-transferable, irrevocable, paid-up license to the subject inventions throughout the world. In addition, our government contracts generally provide that the U.S. government retains unlimited rights in the technical data produced under such government contract.

Furthermore, in most government contracts, including those awarded to us, much of the award amounts are not provided to the recipient until the underlying contract options are exercised. Such options may be exercised at the option of the government and, as a result, there is no guarantee that the government will exercise such options. If the U.S. government chooses not to exercise the options under the contracts it has with us, we will not be able to realize the full value of the awarded contracts, which may result in a material and adverse effect on our business, financial condition and results of operations.

Our business could be adversely affected by a negative audit by the U.S. government.

As a U.S. government contractor, we may become subject to periodic audits and reviews by U.S. government agencies such as the Defense Contract Audit Agency (the “DCAA”). These agencies review a contractor’s performance under its contracts, cost structure and compliance with applicable laws, regulations and standards. The DCAA also reviews the adequacy of, and a contractor’s compliance with, its internal control systems and policies, including the contractor’s purchasing, property, estimating, compensation and management information systems. Any costs found to be improperly allocated to a specific contract will not be reimbursed, which such costs already reimbursed must be refunded.

Based on the results of these audits, the U.S. government may adjust our contract-related costs and fees, including allocated indirect costs. In addition, if an audit or review uncovers any improper or illegal activity, we may be subject to civil and criminal penalties and administrative sanctions, including termination of our contracts, forfeiture of profits, suspension of payments, fines and suspension or prohibition from doing business with the U.S. government. We could also suffer serious harm to our reputation if allegations of impropriety were made against us. In addition, under U.S. government purchasing regulations, some of our costs, including most financing costs, amortization of intangible assets, portions of our R&D costs and some marketing expenses, may not be reimbursable or allowed under our contracts. Further, as a U.S. government contractor, we may become subject to an increased risk of investigations, criminal prosecution, civil fraud, whistleblower lawsuits and other legal actions and liabilities to which purely private sector companies are not.
 
RISKS RELATING TO OUR INTELLECTUAL PROPERTY

We rely upon licensed patents to protect our technology. We may be unable to obtain or protect such intellectual property rights and we may be liable for infringing upon the intellectual property rights of others.

Our ability to compete effectively will depend on our ability to maintain the proprietary nature of our technologies and the proprietary technology of others with which we have entered into licensing agreements. We have entered into five separate exclusive license agreements to license our product candidates that are not owned by us and some product candidates are covered by up to three separate license agreements. Pursuant to these license agreements we maintain patents and patent applications covering our product candidates. We do not know whether any of these patent applications that are still in the approval process will ultimately result in the issuance of a patent with respect to the technology owned by us or licensed to us. The patent position of pharmaceutical or biotechnology companies, including ours, is generally uncertain and involves complex legal and factual considerations. The standards that the United States Patent and Trademark Office use to grant patents are not always applied predictably or uniformly and can change. There is also no uniform, worldwide policy regarding the subject matter and scope of claims granted or allowable in pharmaceutical or biotechnology patents. Accordingly, we do not know the degree of future protection for our proprietary rights or the breadth of claims that will be allowed in any patents issued to us or to others.

Our technology may be found in the future to infringe upon the rights of others or be infringed upon by others. In such a case, others may assert infringement claims against us, and should we be found to infringe upon their patents, or otherwise impermissibly utilize their intellectual property, we might be forced to pay damages, potentially including treble damages, if we are found to have willfully infringed on such parties’ patent rights. Furthermore, parties making claims against us may be able to obtain injunctive or other equitable relief which could effectively block our ability to further develop, commercialize and sell products. In addition to any damages we might have to pay, we may be required to obtain licenses from the holders of this intellectual property, enter into royalty agreements, or redesign our products so as not to utilize this intellectual property, each of which may prove to be uneconomical or otherwise impossible. Conversely, we may not always be able to successfully pursue our claims against others that infringe upon our technology and the technology exclusively licensed by us or developed with our collaborative partners. Thus, the proprietary nature of our technology or technology licensed by us may not provide adequate protection against competitors.

 
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Moreover, the cost to us of any litigation or other proceeding relating to our patents and other intellectual property rights, even if resolved in our favor, could be substantial and the litigation would divert our management’s efforts and our resources. Uncertainties resulting from the initiation and continuation of any litigation could limit our ability to continue our operations.

If we fail to comply with our obligations under our license agreement with third parties, we could lose our ability to develop our product candidates.

The manufacture and sale of any products developed by us may involve the use of processes, products or information, the rights to certain of which are owned by others. Although we have obtained exclusive licenses for our product candidates from the Cleveland Clinic Foundation (“CCF”), Roswell Park Cancer Institute (“RPCI”) and Children’s Cancer Institute Australia (“CCIA”) with regard to the use of patent applications as described above and certain processes, products and information of others, these licenses could be terminated or expire during critical periods and we may not be able to obtain licenses for other rights that may be important to us, or, if obtained, such licenses may not be obtained on commercially reasonable terms. Furthermore, some of our product candidates require the use of technology licensed from multiple third parties, each of which is necessary for the development of such product candidates. If we are unable to maintain and/or obtain licenses, we may have to develop alternatives to avoid infringing upon the patents of others, potentially causing increased costs and delays in product development and introduction or precluding the development, manufacture, or sale of planned products. Additionally, the patents underlying any licenses may not be valid and enforceable. To the extent any products developed by us are based on licensed technology, royalty payments on the licenses will reduce our gross profit from such product sales and may render the sales of such products uneconomical.

Our current exclusive licenses impose various development, royalty, diligence, record keeping, insurance and other obligations on us. If we breach any of these obligations and do not cure such breaches within the relevant cure period, the licensor may have the right to terminate the license, which could result in us being unable to develop, manufacture and sell products that are covered by the licensed technology or enable a competitor to gain access to the licensed technology.

In addition, while we cannot currently determine the dollar amount of the royalty and other payments we will be required to make in the future under the license agreements, if any, the amounts may be significant. The dollar amount of our future payment obligations will depend on the technology and intellectual property we use in products that we successfully develop and commercialize, if any.
 
If we are not able to protect and control our unpatented trade secrets, know-how and other technology, we may suffer competitive harm.

We also rely on a combination of trade secrets, know-how, technology and nondisclosure and other contractual agreements and technical measures to protect our rights in the technology. However, trade secrets are difficult to protect and we rely on third parties to develop our products and thus must share trade secrets with them. We seek to protect our proprietary technology in part by entering into confidentiality agreements and, if applicable, material transfer agreements, collaborative research agreements, consulting agreements or other similar agreements with our collaborators, advisors, employees and consultants prior to beginning research or disclosing proprietary information. These agreements will typically restrict the ability of our collaborators, advisors, employees and consultants to publish data potentially relating to our trade secrets. Our academic collaborators typically have rights to publish data, provided that we are notified in advance and may delay publication for a specified time in order to secure our intellectual property rights arising from the collaboration. Despite our efforts to protect our trade secrets, our competitors may discover our trade secrets, either through breach of these agreements, independent development or publication of information including our trade secrets in cases where we do not have proprietary or otherwise protected rights at the time of publication. If any trade secret, know-how or other technology not protected by a patent or intellectual property right were disclosed to, or independently developed by, a competitor, our business, financial condition and results of operations could be materially adversely affected.
 
RISKS RELATING TO OUR INDUSTRY AND OTHER EXTERNAL FACTORS

The biopharmaceutical market in which we compete is highly competitive.
 
The biopharmaceutical industry is characterized by rapid and significant technological change. Our success will depend on our ability to develop and apply our technologies in the design and development of our product candidates and to establish and maintain a market for our product candidates. In addition, there are many companies, both public and private, including major pharmaceutical and chemical companies, specialized biotechnology firms, universities and other research institutions engaged in developing pharmaceutical and biotechnology products. Many of these companies have substantially greater financial, technical, research and development resources and human resources than us. Competitors may develop products or other technologies that are more effective than those that are being developed by us or may obtain FDA or other governmental approvals for products more rapidly than us. If we commence commercial sales of products, we still must compete in the manufacturing and marketing of such products, areas in which we have no experience.

 
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The market for U.S. and other government funding is highly competitive.

Our biodefense product candidate, Entolimod, faces significant competition for U.S. government funding for both development and procurement of medical countermeasures for biological, chemical and nuclear threats, diagnostic testing systems and other emergency preparedness countermeasures. In addition, we may not be able to compete effectively if our products and product candidates do not satisfy government procurement requirements of the U.S. government with respect to biodefense products. Our opportunities to succeed in this industry could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer side effects, are more convenient or are less expensive than any products that we may develop.

Our growth could be limited if we are unable to attract and retain key personnel and consultants.

We have limited experience in filing and prosecuting regulatory applications to obtain marketing approval from the FDA or other regulatory authorities. The loss of services of one or more of our key employees or consultants could have a negative impact on our business or our ability to expand our research, development and clinical programs. We depend on our scientific and clinical collaborators and advisors, all of whom have outside commitments that may limit their availability to us. In addition, we believe that our future success will depend in large part upon our ability to attract and retain highly skilled scientific, managerial and marketing personnel, particularly as we expand our activities in clinical trials, the regulatory approval process, external partner solicitations and sales and manufacturing. We routinely enter into consulting agreements with our scientific and clinical collaborators and advisors, opinion leaders and heads of academic departments in the ordinary course of our business. We also enter into contractual agreements with physicians and institutions who recruit patients into our clinical trials on our behalf in the ordinary course of our business. Notwithstanding these arrangements, we face significant competition for this type of personnel and for employees from other companies, research and academic institutions, government entities and other organizations. We cannot predict our success in hiring or retaining the personnel we require for continued growth.

We may be subject to damages resulting from claims that we, our employees, or our consultants have wrongfully used or disclosed alleged trade secrets of their former employers.

We engage as employees and consultants individuals who were previously employed at other biotechnology or pharmaceutical companies, including at competitors or potential competitors. Although no claims against us are currently pending, we may become subject to claims that we or our employees have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and distract management.

We may incur substantial liabilities from any product liability and other claims if our insurance coverage for those claims is inadequate.

We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and will face an even greater risk if the product candidates are sold commercially. An individual may bring a product liability claim against us if one of the product candidates causes, or merely appears to have caused, an injury. If we cannot successfully defend ourselves against the product liability claim, we will incur substantial liabilities. Regardless of merit or eventual outcome, product liability claims may result in:

decreased demand for our product candidates;
injury to our reputation;
withdrawal of clinical trial participants;
costs of related litigation;
diversion of our management’s time and attention;
substantial monetary awards to patients or other claimants;
loss of revenues;
the inability to commercialize product candidates; and
increased difficulty in raising required additional funds in the private and public capital markets.
 
We currently have product liability insurance and intend to expand such coverage from coverage for clinical trials to include the sale of commercial products if marketing approval is obtained for any of our product candidates. However, insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage that will be adequate to satisfy any liability that may arise.

 
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From time to time, we may also become subject to litigation, such as stockholder derivative claims, which could involve our directors and officers as defendants. We currently have D&O insurance to cover such risk exposure for our directors and officers. Our bylaws require us to indemnify our current and past directors and officers from reasonable expenses related to the defense of any action arising from their service to us. Our certificate of incorporation and by-laws include provisions to indemnify the directors and officers to the fullest extent permitted by the Delaware General Corporation Law, including circumstances under which indemnification is otherwise discretionary. If our D&O insurance is insufficient to cover all such expenses for all directors and officers, we would be obligated to cover any shortfall, which may be substantial. Such expenditure could have a material adverse effect on our results of operation, financial condition and liquidity. Further, if D&O insurance becomes prohibitively expensive to maintain in the future, we may be unable to renew such insurance on economic terms or unable renew such insurance at all. The lack of D&O insurance may make it difficult for us to retain and attract talented and skilled directors and officers to serve our company, which could adversely affect our business.
 
Political or social factors may delay or impair our ability to market our products.

Entolimod for biodefense applications is being developed to treat a disease radiation sickness, which is a disease that may be caused by terrorist acts. The political and social responses to terrorism have been highly charged and unpredictable. Political or social pressures may delay or cause resistance to bringing our products to market or limit pricing of our products, which would harm our business. Changes to favorable laws, such as the Project BioShield Act, could have a material adverse effect on our ability to generate revenue and could require us to reduce the scope of or discontinue our operations.
 
We hope to continue receiving funding from the DoD and other government agencies for the development of Entolimod. Changes in government budgets and agendas, however, may result in future funding being decreased and de-prioritized, government contracts contain provisions that permit cancellation in the event that funds are unavailable to the government agency. Furthermore, we cannot be certain of the timing of any future funding and substantial delays or cancellations of funding could result from protests or challenges from third parties. If the U.S. government fails to continue to adequately fund R&D programs, we may be unable to generate sufficient revenues to continue operations. Similarly, if we develop a product candidate that is approved by the FDA, but the U.S. government does not place sufficient orders for this product, our future business may be harmed.
 
Failure to comply with the U.S. Foreign Corrupt Practices Act and similar foreign laws could subject us to penalties and other adverse consequences.

We are required to comply with the United States Foreign Corrupt Practices Act, or FCPA, which prohibits U.S. companies from engaging in bribery or other prohibited payments to foreign officials for the purpose of obtaining or retaining business. Foreign companies, including some that may compete with us, are not subject to these prohibitions. Furthermore, foreign jurisdictions in which we operate may have laws that are similar to the FCPA to which we are or may become subject. This may place us at a significant competitive disadvantage. Corruption, extortion, bribery, pay-offs, theft and other fraudulent practices may occur from time to time in the foreign markets where we conduct business. Although we inform our personnel that such practices are illegal, we can make no assurance that our employees or other agents will not engage in illegal conduct for which we might be held responsible. If our employees or other agents are found to have engaged in such practices, we could suffer severe penalties and other consequences that may have a material adverse effect on our business, financial condition and results of operations.

The FCPA also obligates companies whose securities are listed in the U.S. to comply with certain accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries and to devise and maintain an adequate system of internal accounting controls for international operations.
 
Compliance with the FCPA and similar foreign anti-bribery laws is expensive and difficult, particularly in countries in which corruption is a recognized problem. In addition, such anti-bribery laws present particular challenges in the biotech or pharmaceutical industry, because, in many countries, hospitals are operated by the government and doctors and other hospital employees may be considered foreign officials.

Our business is subject to changing regulations for corporate governance and public disclosure that has increased both our costs and the risk of noncompliance.

Each year, under Section 404 of the Sarbanes-Oxley Act, we are required to evaluate our internal controls systems in order to allow management to report on our internal controls as required by and to permit our independent registered public accounting firm to attest to our internal controls. As a result, we have incurred and will continue to incur additional expenses and divert our management’s time to comply with these regulations. In addition, if we cannot continue to comply with the requirements of Section 404 in a timely manner, we might be subject to sanctions or investigation by regulatory and quasi-governmental authorities, such as the SEC, the Public Company Accounting Oversight Board, or The NASDAQ Stock Market. Any such action could adversely affect our financial results and the market price of our common stock.

 
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In addition, stockholder activism, the current political environment and the current high level of government intervention and regulatory reform may lead to substantial new regulations and disclosure obligations, which may lead to additional compliance costs and impact the manner in which we operate our business.
 
The price of our common stock has been and could remain volatile, which may in turn expose us to securities litigation.

The market price of our common stock has historically experienced and may continue to experience significant volatility. From first quarter 2012 through third quarter 2013, the market price of our common stock, which is listed on the NASDAQ Capital Market, fluctuated from a high of $4.06 per share in the first quarter of 2012 to a low of $1.15 in the second quarter of 2012. The listing of our common stock on the NASDAQ Capital Market does not assure that a meaningful, consistent and liquid trading market will exist, and in recent years, the market has experienced extreme price and volume fluctuations that have particularly affected the market prices of many smaller companies like us. Our common stock is thus subject to this volatility in addition to volatility caused by the occurrence of industry and company specific events. Factors that could cause fluctuations include, but are not limited to, the following:

·
our progress in developing and commercializing our products;
·
price and volume fluctuations in the overall stock market from time to time;
·
fluctuations in stock market prices and trading volumes of similar companies;
·
actual or anticipated changes in our earnings or fluctuations in our operating results or in the expectations of securities analysts;
·
general economic conditions and trends;
·
major catastrophic events;
·
sales of large blocks of our stock;
·
departures of key personnel;
·
changes in the regulatory status of our product candidates, including results of our pre-clinical studies and clinical trials;
·
status of contract and funding negotiations relating to our product candidates;
·
events affecting CCF, RPCI or our other collaborators;
·
announcements of new products or technologies, commercial relationships or other events by us or our competitors;
·
regulatory developments in the U.S. and other countries;
·
failure of our common stock to be listed or quoted on the NASDAQ Capital Market, other national market system or any national stock exchange;
·
changes in accounting principles; and
·
discussion of us or our stock price by the financial and scientific press and in online investor communities.

As a result of the volatility of our stock price, we could be subject to securities litigation, which could result in substantial costs and divert management’s attention and company resources from our business.
 
* Issuance of additional equity may adversely affect the market price of our stock.

We are currently authorized to issue 160,000,000 shares of common stock and 10,000,000 of preferred stock. As of September 30, 2013, we had 45,157,144 shares of our common stock and no shares of our preferred stock issued and outstanding and warrants exercisable into 10,534,245 shares and 5,016,916 options outstanding. To the extent the shares of common stock are issued or options and warrants are exercised, holders of our common stock will experience dilution.
 
In the event of any future issuances of equity securities or securities convertible into or exchangeable for, common stock, holders of our common stock may experience dilution. Furthermore, our outstanding warrants contain provisions that, in certain circumstances, could result in the number of shares of common stock issuable upon the exercise of such warrants to increase and/or the exercise price of such warrants to decrease.
 
Moreover, our board of directors is authorized to issue preferred stock without any action on the part of our stockholders. Our board of directors also has the power, without stockholder approval, to set the terms of any such preferred stock that may be issued, including voting rights, conversion rights, dividend rights, preferences over our common stock with respect to dividends or if we liquidate, dissolve or wind up our business and other terms. If we issue preferred stock in the future that has preference over our common stock with respect to the payment of dividends or upon our liquidation, dissolution or winding up, or if we issue preferred stock with voting rights that dilute the voting power of our common stock, the market price of our common stock could decrease. Any provision permitting the conversion of any such preferred stock into our common stock could result in significant dilution to the holders of our common stock.
 
We also consider from time to time various strategic alternatives that could involve issuances of additional common stock, including but not limited to acquisitions and business combinations, but do not currently have any definitive plans to enter into any of these transactions.

 
33

 
 
We have no plans to pay dividends on our common stock and investors may not receive funds without selling their common stock.

We have not declared or paid any cash dividends on our common stock, nor do we expect to pay any cash dividends on our common stock for the foreseeable future. We currently intend to retain any additional future earnings to finance our operations and growth and, therefore, we have no plans to pay cash dividends on our common stock at this time. Any future determination to pay cash dividends on our common stock will be at the discretion of our board of directors and will be dependent on our earnings, financial condition, operating results, capital requirements, any contractual restrictions, regulatory and other restrictions on the payment of dividends by our subsidiaries to us and other factors that our board of directors deems relevant.
 
Accordingly, investors may have to sell some or all of their common stock in order to generate cash from your investment. Investors may not receive a gain on your investment when they sell our common stock and may lose the entire amount of their investment.

Provisions in our charter documents and Delaware law may inhibit a takeover or impact operational control of our company, which could adversely affect the value of our common stock.

Our certificate of incorporation and bylaws, as well as Delaware corporate law, contain provisions that could delay or prevent a change of control or changes in our management that a stockholder might consider favorable. These provisions include, among others, prohibiting stockholder action by written consent, advance notice for raising business or making nominations at meetings of stockholders and the issuance of preferred stock with rights that may be senior to those of our common stock without stockholder approval. These provisions would apply even if a takeover offer may be considered beneficial by some of our stockholders. If a change of control or change in management is delayed or prevented, the market price of our common stock could decline.
 
RISKS RELATED TO CONDUCTING BUSINESS IN THE RUSSIAN FEDERATION

Emerging markets, such as Russia, are subject to greater risks than more developed markets and financial turmoil in Russia could disrupt our business.

Investors in emerging markets such as Russia should be aware that these markets are subject to greater risks than more developed markets, including significant economic risks. Prospective investors in our common stock should note that emerging markets are subject to rapid change and that the information set out in this Form 10-Q about our operations in Russia may become outdated relatively quickly.
 
Future deterioration in the international economic situation may cause financial instability in Russia and could adversely affect our business.

The Russian economy is vulnerable to market downturns and economic slowdowns elsewhere in the world, has experienced periods of considerable instability and has been subject to abrupt downturns. Although the Russian economy showed positive trends until 2008, including annual increases in the gross domestic product, a relatively stable currency, strong domestic demand, rising real wages and a reduced rate of inflation, these trends were interrupted by the global financial crisis in late 2008, in which Russia experienced adverse economic and financial effects including a substantial decrease in the growth rate of gross domestic product, depreciation of local currency and a decline in domestic and international demand for its products and services. More recently, the negative trends of the global economy and volatility in the financial markets, partially due to the recent debt crisis in Europe, have resulted in a decreased growth outlook for those countries dependent on Western Europe for trade. The Russian government has taken certain anti-crisis measures including using the “stabilization fund” and hard currency reserves to soften the impact of the global economic downturn on the Russian economy and support the value of the Russian ruble. Should global economic conditions deteriorate significantly, it is possible that the Russian economy could continue to decline in the near future. Further economic instability in Russia where we operate through our consolidated subsidiaries and any future deterioration in the international economic situation could materially adversely affect our business, financial condition and results of operations.

Inflation in Russia and government efforts to combat inflation may contribute significantly to economic uncertainty in Russia and could materially adversely affect our financial condition and results of operations.

The Russian economy has periodically experienced high rates of inflation. According to The World Bank and Bloomberg, the annual inflation rate in Russia, as measured by the consumer price index, was 6.9% in 2010, 8.4% in 2011 and 5.1% in 2012. Periods of higher inflation may slow economic growth. Inflation also is likely to increase some of our costs and expenses including the costs for our subsidiaries to conduct business operations, including any outsourced product testing costs.

 
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* Political and governmental instability in Russia could materially adversely affect our business and operations in these countries.

Since the early 1990s, Russia has sought to transform from a one-party state with a centrally planned economy to a democracy with a market economy. As a result of the sweeping nature of various reforms and the failure of some of them, the political system of Russia remains vulnerable to popular dissatisfaction, including demands for autonomy from particular regional and ethnic groups. Since the breakup of the U.S.S.R. in 1991, the political and economic situation in Russia has generally become more stable. However, there is still a risk of significant changes to the political and economic environment, potential changes in the direction of the reforms or reversal of the reforms. Current and future changes in the Russian government, major policy shifts or lack of consensus between various branches of the government and powerful economic groups could disrupt or reverse economic and regulatory reforms. Any disruption or reversal of reform policies could lead to political or governmental instability or the occurrence of conflicts among powerful economic groups, which could materially adversely affect our business and operations in Russia. Additionally, changes in governmental policies and objectives could affect our ability to apply for and/or receive non-dilutive grants from the Russian Government, such as the grants that we have received from Russian Federation Ministry of Industry & Trade and the Skolkovo Foundation totaling $13.7 million (based on current exchange rates).

A deterioration in political and economic relations between Russia and the United States could materially adversely affect our business and operations in Russia and generally.

Political and economic relations between Russia and the United States are complex. Political, ethnic, religious, historical and other differences have, on occasion, given rise to tensions. The emergence of new or escalated tensions could further exacerbate tensions between Russia and the United States and/or the European Union (EU) where we have manufacturing or other partners, which may have a negative effect on their economy. Any of the foregoing circumstances could materially adversely affect our business and operations in Russia and generally.

The legal system in Russia can create an uncertain environment for business activity, which could materially adversely affect our business and operations in Russia.

The legal framework to support a market economy remains new and in flux in Russia and, as a result, its legal system can be characterized by: inconsistencies between and among laws and governmental, ministerial and local regulations, orders, decisions, resolutions and other acts; gaps in the regulatory structure resulting from the delay in adoption or absence of implementing regulations; selective enforcement of laws or regulations, sometimes in ways that have been perceived as being motivated by political or financial considerations; limited judicial and administrative guidance on interpreting legislation; relatively limited experience of judges and courts in interpreting recent commercial legislation; a perceived lack of judicial and prosecutorial independence from political, social and commercial forces; inadequate court system resources; a high degree of discretion on the part of the judiciary and governmental authorities; and underdeveloped bankruptcy procedures that are subject to abuse.
 
In addition, as is true of civil law systems generally, judicial precedents generally have no binding effect on subsequent decisions. Not all legislation and court decisions in Russia are readily available to the public or organized in a manner that facilitates understanding. Enforcement of court orders can in practice be very difficult. All of these factors make judicial decisions difficult to predict and effective redress uncertain. Additionally, court claims and governmental prosecutions may be used in furtherance of what some perceive to be political or commercial aims.

The untested nature of much of recent legislation in Russia and the rapid evolution of its legal system may result in ambiguities, inconsistencies and anomalies in the application and interpretation of laws and regulations. Any of these factors may affect our ability to enforce our rights under our contracts or to defend ourselves against claims by others, or result in our being subject to unpredictable requirements. These uncertainties also extend to property rights and the expropriation or nationalization of any of our entities, their assets or portions thereof, potentially without adequate compensation, could materially adversely affect our business, financial condition and results of operations.
 
Changes in the tax system in Russia or the arbitrary or unforeseen application of existing rules could materially adversely affect our financial condition and results of operations.

There have been significant changes to the taxation system in Russia in recent years as the authorities have gradually replaced legislation regulating the application of major taxes such as corporate income tax, value added tax (VAT), corporate property tax and other taxes with new legislation. Tax authorities in Russia have also been aggressive in their interpretation of tax laws and their many ambiguities, as well as in their enforcement and collection activities. Technical violations of contradictory laws and regulations, many of which are relatively new and have not been subject to extensive application or interpretation, can lead to penalties. High-profile companies can be particularly vulnerable to aggressive application of unclear requirements. Many companies must negotiate their tax bills with tax inspectors who may demand higher taxes than applicable law appears to provide. Our Russian subsidiaries’ tax liabilities may become greater than the estimated amount that they have expensed to date and paid or accrued on the balance sheets, particularly if the tax benefits currently received in Russia are changed or removed. Any additional tax liability, as well as any unforeseen changes in tax laws, could materially adversely affect our future results of operations, financial condition or cash flows in a particular period.

 
35

 
 
In October 2006, the Supreme Arbitration Court of Russia issued a ruling that introduced the concept of an “unjustified tax benefit,” which is a benefit that may be disallowed for tax purposes. Specific examples cited by the court include benefits obtained under transactions lacking a business purpose (i.e., when the only purpose of a deal or structure is to derive tax benefits). The tax authorities have actively sought to apply this concept when challenging tax positions taken by taxpayers. Although the intention of the ruling was to combat tax abuse, in practice there is no assurance that the tax authorities will not seek to apply this concept in a broader sense than may have been intended by the court. In addition, the tax authorities and the courts have indicated a willingness to interpret broadly the application of criminal responsibility for tax violations.

The tax systems in Russia impose additional burdens and costs on our operations there and complicate our tax planning and related business decisions. For example, the tax environment in Russia has historically been complicated by contradictions in Russian tax law and tax laws are unclear in areas such as the deductibility of certain expenses. This uncertainty could result in a greater than expected tax burden and potentially exposes us to significant fines and penalties and enforcement measures, despite our best efforts at compliance. These factors raise the risk of a sudden imposition of arbitrary or onerous taxes on our operations in these countries. This could materially adversely affect our financial condition and results of operations.

We may be exposed to liability for actions taken by our subsidiaries.

Under the laws of Russia, we may be jointly and severally liable for obligations of our subsidiaries. We may also incur secondary liability and, in certain cases, liability to creditors for obligations of our subsidiaries in certain instances involving bankruptcy or insolvency. This type of liability could result in significant obligations and could materially adversely affect our financial condition and results of operations.

Our majority-owned and wholly-owned Russian subsidiaries can be forced into liquidation on the basis of formal noncompliance with certain legal requirements.

Our majority-owned and wholly-owned subsidiaries operate in Russia primarily through Incuron, Panacela Labs, LLC and BioLab 612, all of which were organized under the laws of the Russian Federation. Certain provisions of Russian law may allow a court to order the liquidation of a locally organized legal entity on the basis of its formal noncompliance with certain requirements during formation, reorganization or during its operations. Additionally, Russian corporate law allows the government to liquidate a company if its net assets fall below a certain threshold. Similarly, there have also been cases in Russia in which formal deficiencies in the establishment process of a legal entity or noncompliance with provisions of law have been used by courts as a basis for liquidation of a legal entity. Weaknesses in the legal systems of Russia create an uncertain legal environment, which makes the decisions of a court or a governmental authority difficult, if not impossible, to predict. If involuntary liquidation of either of the aforementioned entities were to occur, such liquidation could materially adversely affect our financial condition and results of operations.

Crime and corruption could disrupt our ability to conduct our business.

Political and economic changes in Russia in recent years have resulted in significant dislocations of authority. The local and international press has reported the existence of significant organized criminal activity, particularly in large metropolitan centers. In addition, the local and international press has reported high levels of corruption, including the bribing of officials for the purpose of initiating investigations by government agencies. Press reports have also described instances in which state officials have engaged in selective investigations and prosecutions to further the interests of the state and individual officials, as well as private businesses, including competitors and corporate raiders. Corruption in Russia is pervasive and, in some cases, is worsening. The government in Russia has recently pursued a campaign against corruption. However, there is no assurance that such laws or other laws enacted elsewhere will be applied with any effectiveness by the local authorities and the continuing effects of corruption, money laundering and other criminal activity could have a negative effect on the Russian economy and could materially adversely affect our business in Russia.
 

None.

 
36

 
 

None.

 
None.


None.
 
 
37

 
 
 
(a) The following exhibits are included as part of this report:
 
Exhibit
Number
 
Description of Document
     
4.1
 
Warrant to Purchase Common Stock issued to Open Joint Stock Company “Rusnano” (Incorporated by reference to Form 8-K filed on September 5, 2013).
     
4.2
 
Warrant Agreement, dated September 30, 2013, between Cleveland BioLabs, Inc. and Hercules Technology II, L.P.
     
10.1
 
Master Agreement, dated September 3, 2013, by and among Panacela Labs, Inc., Cleveland Biolabs, Inc. and Open Joint Stock Company “Rusnano” (Incorporated by reference to Form 8-K filed on September 5, 2013).
     
10.2
 
Convertible Loan Agreement, dated September 3, 2013, between Open Joint Stock Company “Rusnano” and Panacela Labs, Inc. (Incorporated by reference to Form 8-K filed on September 5, 2013).
     
10.3
 
Loan and Security Agreement, dated September 30, 2013, by and among Cleveland BioLabs, Inc., Biolab 612, LLC and Hercules Technology II, L.P.
     
31.1
 
Rule 13a-14(a)/15d-14(a) Certification of Yakov Kogan.
     
31.2
 
Rule 13a-14(a)/15d-14(a) Certification of C. Neil Lyons.
     
32.1
 
Certification pursuant to 18 U.S.C. Section 1350.
     
101.1
 
The following information from CBLI’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2013, formatted in Extensible Business Reporting Language (XBRL): (i) Consolidated Balance Sheets as of September 30, 2013 and December 31, 2012; (ii) Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2013 and 2012; (iii) Consolidated Statements of Comprehensive Loss for the Three and Nine Months Ended September 30, 2013 and 2012; (iv) Consolidated Statements of Cash Flows for the Nine Months ended September 30, 2013 and 2012; (v) Consolidated Statements of Stockholders’ Equity for the Nine Months Ended September 30, 2013; and (vi) Notes to Consolidated Financial Statements.*

*           Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files on Exhibit 101 hereto are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, and otherwise are not subject to liability under those sections.
 
 
38

 
 

In accordance with 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.

 
CLEVELAND BIOLABS, INC.
 
       
Dated: November 8, 2013
By:
/s/ YAKOV KOGAN
 
 
Yakov Kogan
Chief Executive Officer
(Principal Executive Officer)
 
       
Dated: November 8, 2013
By:
/s/ C. NEIL LYONS
 
   
C. Neil Lyons
Chief Financial Officer
(Principal Financial Officer)
 
 
 
 
39

EX-4.2 2 exh_42.htm EXHIBIT 4.2 exh_42.htm
Exhibit 4.2
 
THESE SECURITIES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR ANY STATE SECURITIES LAWS.  THEY MAY NOT BE SOLD, OFFERED FOR SALE, PLEDGED, OR HYPOTHECATED IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT RELATED THERETO OR AN OPINION OF COUNSEL (WHICH MAY BE COMPANY COUNSEL) REASONABLY SATISFACTORY TO THE COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR ANY APPLICABLE STATE SECURITIES LAWS.
 
Warrant No. I-1
WARRANT AGREEMENT

To Purchase Shares of the Common Stock of

Cleveland BioLabs, Inc.

Dated as of September 30, 2013 (the “Effective Date”)

WHEREAS, Cleveland BioLabs, Inc., a Delaware corporation (the “Company”), has entered into a Loan and Security Agreement of even date herewith (as amended and in effect from time to time, the “Loan Agreement”) with Hercules Technology II, L.P., a Delaware limited partnership (the “Warrantholder”);

WHEREAS, pursuant to the Loan Agreement and as additional consideration to the Warrantholder for, among other things, its agreements in the Loan Agreement, the Company has agreed to issue to the Warrantholder this Warrant Agreement, evidencing the right to purchase shares of the Company’s Common Stock (this “Warrant” or this “Agreement”);
 
NOW, THEREFORE, in consideration of the Warrantholder having executed and delivered the Loan Agreement and provided the financial accommodations contemplated therein, and in consideration of the mutual covenants and agreements contained herein, the Company and Warrantholder agree as follows:
 
 
SECTION 1.
GRANT OF THE RIGHT TO PURCHASE COMMON STOCK.
 
(a)           For value received, the Company hereby grants to the Warrantholder, and the Warrantholder is entitled, upon the terms and subject to the conditions hereinafter set forth, to subscribe for and purchase, from the Company, up to such number of shares of Common Stock (as defined below) as determined in Section 1(b) below, at a purchase price per share equal to the Exercise Price (as defined below).  The number and Exercise Price of such shares are subject to adjustment as provided in Section 8.  As used herein, the following terms shall have the following meanings:
 
Act” means the Securities Act of 1933, as amended.
 
Charter” means the Company’s Certificate of Incorporation or other constitutional document, as may be amended and in effect from time to time.
 
Common Stock” means the Company’s common stock, $0.005 par value per share, as presently constituted under the Charter, and any class and/or series of Company capital stock for or into which such common stock may be converted or exchanged in a reorganization, recapitalization or similar transaction.
 
 
 

 
Effective Price” shall mean the quotient determined by dividing (i) the aggregate gross cash consideration received, or deemed to have been received, by the Company, for the issuance of additional shares of Common Stock by the Company (including, without limitation, shares of Common Stock issuable upon the conversion or exercise of Convertible Securities (as defined below) issued by the Company) for cash for financing purposes in a single transaction or series of related transactions not registered under the Act (including, without limitation, a so-called PIPE transaction) after the Effective Date, by (ii) the total number of such additional shares of Common Stock issued or deemed to be issued in such transaction.  In the event the Company issues any Convertible Securities (as defined below) in such transaction, then the calculation of “Effective Price” shall be adjusted as follows: (a) the amount of cash consideration included in the numerator in clause (i) above shall include the amount determined by multiplying the conversion or exercise price, as applicable, of any shares of Common Stock issuable upon conversion or exercise of any such Convertible Securities (the “Conversion Shares”) by the number of Conversion Shares; and (b) the number of Conversion Shares shall be included in the denominator in clause (ii) above.

Exercise Price”  means $1.60, subject to adjustment from time to time in accordance with the provisions of this Warrant; provided, that if, at any time and from time to time on or after the Effective Date and prior to the first anniversary thereof, the Company shall sell and issue shares of Common Stock, or securities, instruments or other rights exercisable for, convertible into or otherwise representing the right to acquire shares of Common Stock (collectively, “Convertible Securities”) to one or more investors for cash for financing purposes, in a single transaction or series of related transactions not registered under the Act (including, without limitation, a so-called PIPE transaction), at an Effective Price per share of Common Stock less than the Exercise Price in effect as of immediately prior to the consummation of such sale and issuance, then from and after such consummation, the Exercise Price shall equal such lower Effective Price, subject to adjustment thereafter from time to time in accordance with the provisions of this Warrant.
 
Liquid Sale” means the closing of a Merger Event in which the consideration received by the Company and/or its stockholders, as applicable, consists solely of cash and/or Marketable Securities.
 
Marketable Securities” in connection with a Merger Event means securities meeting all of the following requirements: (i) the issuer thereof is then subject to the reporting requirements of Section 13 or Section 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and is then current in its filing of all required reports and other information under the Act and the Exchange Act; (ii) the class and series of shares or other security of the issuer that would be received by the Warrantholder in connection with the Merger Event were the Warrantholder to exercise this Warrant on or prior to the closing thereof is then traded on a national securities exchange or over-the-counter market, and (iii) the Warrantholder would not be restricted by contract or by applicable federal and state securities laws from publicly re-selling, within six (6) months and one day following the closing of such Merger Event, all of the issuer’s shares and/or other securities that would be received by the Warrantholder in such Merger Event were the Warrantholder to exercise this Warrant in full on or prior to the closing of such Merger Event.
 
Merger Event” means any of the following: (i) a sale, lease or other transfer of all or substantially all assets of the Company, (ii) any merger or consolidation involving the Company in which the Company is not the surviving entity or in which the outstanding shares of the Company’s capital stock are otherwise converted into or exchanged for shares of capital stock or other securities or property of another entity, or (iii) any sale by holders of the outstanding voting equity securities of the Company in a single transaction or series of related transactions of shares constituting a majority of the outstanding combined voting power of the Company.
 
 
2

 
"Purchase Price" means, with respect to any exercise of this Warrant, an amount equal to the then-effective Exercise Price multiplied by the number of shares of Common Stock as to which this Warrant is then exercised.
 
(b)           Number of Shares. This Warrant shall be exercisable for 156,250 shares of Common Stock, subject to adjustment from time to time in accordance with the provisions of this Warrant.

 
SECTION 2.
TERM OF THE AGREEMENT.
 
The term of this Agreement and the right to purchase Common Stock as granted herein shall commence on the Effective Date and, subject to Section 8(a) below, shall be exercisable for a period ending the fifth (5th) anniversary of the Effective Date.
 
 
SECTION 3.
EXERCISE OF THE PURCHASE RIGHTS.
 
(a)           Exercise.  The purchase rights set forth in this Agreement are exercisable by the Warrantholder, in whole or in part, at any time, or from time to time, prior to the expiration of the term set forth in Section 2, by tendering to the Company at its principal office a notice of exercise in the form attached hereto as Exhibit I (the “Notice of Exercise”), duly completed and executed.  Promptly upon receipt of the Notice of Exercise and the payment of the Purchase Price in accordance with the terms set forth below, and in no event later than three (3) days thereafter, the Company shall issue to the Warrantholder a certificate for the number of shares of Common Stock purchased and shall execute the acknowledgment of exercise in the form attached hereto as Exhibit II (the “Acknowledgment of Exercise”) indicating the number of shares which remain subject to future purchases under this Warrant, if any.

The Purchase Price may be paid at the Warrantholder’s election either (i) by cash or check, or (ii) by surrender of all or a portion of the Warrant  for shares of Common Stock to be exercised under this Agreement and, if applicable, an amended Agreement setting forth the remaining number of shares purchasable hereunder, as determined below (“Net Issuance”).  If the Warrantholder elects the Net Issuance method, the Company will issue shares of Common Stock in accordance with the following formula:

X = Y(A-B)
A

Where:
X =
the number of shares of Common Stock to be issued to the Warrantholder.
 
 
Y =
the number of shares of Common Stock requested to be exercised under this Agreement.
 
 
A =
the then-current fair market value of one (1) share of Common Stock at the time of exercise.
 
 
3

 
B =           the then-effective Exercise Price.
 
For purposes of the above calculation, the current fair market value of shares of Common Stock shall mean with respect to each share of Common Stock:

(i)           at all times when the Common Stock shall be traded on a national securities exchange, inter-dealer quotation system or over-the-counter bulletin board service, the average of the closing prices over a five (5) day period ending three days before the day the current fair market value of the securities is being determined;

(ii)           if the exercise is in connection with a Merger Event, the fair market value of a share of Common Stock shall be deemed to be the per share value received by the holders of the outstanding shares of Common Stock pursuant to such Merger Event as determined in accordance with the definitive transaction documents executed among the parties in connection therewith; or

(iii)           in cases other than as described in the foregoing clauses (i) and (ii), the current fair market value of a share of Common Stock shall be determined in good faith by the Company’s Board of Directors.

Upon partial exercise by either cash or, upon request by the Warrantholder and surrender of all or a portion of this Warrant, Net Issuance, prior to the expiration or earlier termination hereof, the Company shall promptly issue an amended Agreement representing the remaining number of shares purchasable hereunder. All other terms and conditions of such amended Agreement shall be identical to those contained herein, including, but not limited to the Effective Date hereof.

(b)           Exercise Prior to Expiration.  To the extent this Warrant is not previously exercised as to all shares subject hereto, and if the then-current fair market value of one share of Common Stock is greater than the Exercise Price then in effect, or, in the case of a Liquid Sale, where the value per share of Common Stock (as determined as of the closing of such Liquid Sale in accordance with the definitive agreements executed by the parties in connection with such Merger Event) to be paid to the holders thereof is greater than the Exercise Price then in effect, this Agreement shall be deemed automatically exercised on a Net Issuance basis pursuant to Section 3(a) (even if not surrendered) as of immediately before its expiration determined in accordance with Section 2.  For purposes of such automatic exercise, the fair market value of one share of Common Stock upon such expiration shall be determined pursuant to Section 3(a).  To the extent this Warrant or any portion hereof is deemed automatically exercised pursuant to this Section 3(b), the Company agrees to promptly notify the Warrantholder of the number of shares of Common Stock if any, the Warrantholder is to receive by reason of such automatic exercise, and to issue a certificate to Warrantholder evidencing such shares.

 
SECTION 4.
RESERVATION OF SHARES.
 
During the term of this Agreement, the Company will at all times have authorized and reserved a sufficient number of shares of its Common Stock to provide for the exercise of the rights to purchase Common Stock as provided for herein.
 
 
4

 
 
SECTION 5.
NO FRACTIONAL SHARES OR SCRIP.
 
No fractional shares or scrip representing fractional shares shall be issued upon the exercise of this Agreement, but in lieu of such fractional shares the Company shall make a cash payment therefor upon the basis of the Exercise Price then in effect.
 
 
SECTION 6.
NO RIGHTS AS SHAREHOLDER/STOCKHOLDER.
 
Without limitation of any provision hereof, Warrantholder agrees that this Agreement does not entitle the Warrantholder to any voting rights or other rights as a shareholder/stockholder of the Company prior to the exercise of any of the purchase rights set forth in this Agreement.
 
 
SECTION 7.
WARRANTHOLDER REGISTRY.
 
The Company shall maintain a registry showing the name and address of the registered holder of this Agreement.  Warrantholder's initial address, for purposes of such registry, is set forth in Section 12(g) below.  Warrantholder may change such address by giving written notice of such changed address to the Company.
 
 
SECTION 8.
ADJUSTMENT RIGHTS.
 
The Exercise Price and the number of shares of Common Stock purchasable hereunder are subject to adjustment from time to time, as follows:
 
(a)           Merger Event.  In connection with a Merger Event that is a Liquid Sale, this Warrant shall terminate upon the closing of such Liquid Sale.  In connection with a Merger Event that is not a Liquid Sale, the Company shall cause the successor or surviving entity to assume this Warrant and the obligations of the Company hereunder on the closing thereof, and thereafter this Warrant shall be exercisable for the same number and type of securities or other property as the Warrantholder would have received in consideration for the shares of Common Stock issuable hereunder had it exercised the then unexercised portion of this Warrant in full as of immediately prior to such closing, at an aggregate Exercise Price no greater than the aggregate Exercise Price in effect for such unexercised portion as of immediately prior to such closing, and subject to further adjustment from time to time in accordance with the provisions of this Warrant.  Notwithstanding the first sentence of this Section 8(a), in connection with any Liquid Sale and upon Warrantholder’s written election to the Company, the Company shall cause this Warrant to be exchanged, on and as of the closing thereof, without a requirement of formal exercise, for the consideration that Warrantholder would have received (less the Purchase Price) had Warrantholder elected to exercise the then unexercised portion of this Warrant in full as of immediately prior to the closing of such Liquid Sale. The provisions of this Section 8(a) shall similarly apply to successive Merger Events.
 
(b)           Reclassification of Shares.  Except for Merger Events subject to Section 8(a), if the Company at any time shall, by combination, reclassification, exchange or subdivision of securities or otherwise, change any of the securities as to which purchase rights under this Agreement exist into the same or a different number of securities of any other class or classes of securities, this Agreement shall thereafter represent the right to acquire such number and kind of securities as would have been issuable as the result of such change with respect to the securities which were subject to the purchase rights under this Agreement immediately prior to such combination, reclassification, exchange, subdivision or other change. The provisions of this Section 8(b) shall similarly apply to successive combination, reclassification, exchange, subdivision or other change.
 
 
5

 
(c)           Subdivision or Combination of Shares.  If the Company at any time shall combine or subdivide its Common Stock, (i) in the case of a subdivision, the Exercise Price shall be proportionately decreased and the number of shares for which this Warrant is exercisable shall be proportionately increased, or (ii) in the case of a combination, the Exercise Price shall be proportionately increased and the number of shares for which this Warrant is exercisable shall be proportionately decreased.
 
(d)           Stock Dividends.  If the Company at any time while this Agreement is outstanding and unexpired shall:
 
(i)           pay a dividend with respect to the outstanding shares of Common Stock payable in additional shares of Common Stock, then the Exercise Price shall be adjusted, to that price determined by multiplying the Exercise Price in effect immediately prior to such date of determination by a fraction (A) the numerator of which shall be the total number of shares of Common Stock outstanding immediately prior to such dividend or distribution, and (B) the denominator of which shall be the total number of shares of Common Stock outstanding immediately after such dividend or distribution, and the number of shares of Common Stock for which this Warrant is exercisable shall be proportionately increased; or
 
(ii)           make any other dividend or distribution on or with respect to Common Stock, except any dividend or distribution (A) in cash, or (B) specifically provided for in any other clause of this Section 8, then, in each such case, provision shall be made by the Company such that the Warrantholder shall receive upon exercise or conversion of this Warrant a proportionate share of any such distribution as though it were the holder of the Common Stock (or other stock for which the Common Stock is convertible) as of the record date fixed for the determination of the shareholders of the Company entitled to receive such distribution.
 
(e)  Notice of Certain Events.  If: (i) the Company shall declare any dividend or distribution upon its outstanding Common Stock, payable in stock, cash, property or other securities (provided that Warrantholder in its capacity as lender under the Loan Agreement consents to such dividend); (ii) the Company shall offer for subscription pro rata to the holders of its Common Stock any additional shares of stock of any class or other rights; (iii) there shall be any Merger Event; or (iv) there shall be any voluntary dissolution, liquidation or winding up of the Company; then, in connection with each such event, the Company shall give the Warrantholder notice thereof at the same time and in the same manner as it gives notice thereof to the holders of Common Stock.

 
SECTION 9.
REPRESENTATIONS, WARRANTIES AND COVENANTS OF THE COMPANY.
 
(a)      Reservation of Common Stock.  The Company covenants and agrees that all shares of Common Stock, if any, that may be issued upon the exercise of the rights represented by this Warrant will, upon issuance, be validly issued and outstanding, fully paid and non-assessable. The Company further covenants and agrees that the Company will, at all times during the term hereof, have authorized and reserved, free from preemptive rights, a sufficient number of shares of Common Stock to provide for the exercise of the rights represented by this Warrant.  If at any time during the term hereof the number of authorized but unissued shares of Common Stock shall not be sufficient to permit exercise of this Warrant in full, the Company will take such corporate action as may, in the opinion of its counsel, be necessary to increase its authorized but unissued shares of Common Stock to such number of shares as shall be sufficient for such purposes.
 
 
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(b)      Due Authority.  The execution and delivery by the Company of this Agreement and the performance of all obligations of the Company hereunder, including the issuance to Warrantholder of the right to acquire the shares of Common Stock, have been duly authorized by all necessary corporate action on the part of the Company.  This Agreement: (1) does not violate the Company's Charter or current bylaws; (2) does not contravene any law or governmental rule, regulation or order applicable to it; and (3) except as could not reasonably be expected to have a Material Adverse Effect (as defined in the Loan Agreement), does not and will not contravene any provision of, or constitute a default under, any indenture, mortgage, contract or other instrument to which it is a party or by which it is bound.  This Agreement constitutes a legal, valid and binding agreement of the Company, enforceable in accordance with its terms, except as may be limited by bankruptcy, insolvency, reorganization, moratorium or similar laws relating to or affecting creditors’ rights generally (including, without limitation, fraudulent conveyance laws) and by general principles of equity, regardless of whether considered in a proceeding in equity or at law.
 
(c)      Consents and Approvals.  No consent or approval of, giving of notice to, registration with, or taking of any other action in respect of any state, federal or other governmental authority or agency is required with respect to the execution, delivery and performance by the Company of its obligations under this Agreement, except for the filing of notices pursuant to Regulation D under the Act and any filing required by applicable state securities law, which filings will be effective by the time required thereby.
 
(d)      [Intentionally Omitted].
 
(e)      [Intentionally Omitted].
 
(f)       Exempt Transaction.  Subject to the accuracy of the Warrantholder's representations in Section 10, the issuance of the Common Stock upon exercise of this Agreement will constitute a transaction exempt from (i) the registration requirements of Section 5 of the Act, in reliance upon Section 4(2) thereof, and (ii) the qualification requirements of the applicable state securities laws.
 
(g)      Registration Rights.  The Company covenants and agrees with Warrantholder that if the Company, at any time and from time to time on or after the Effective Date and on or before the expiration or earlier termination of this Warrant, proposes to register under the Act any shares of Common Stock held by one or more stockholders of the Company for resale by such stockholders, whether on a Form S-3 registration statement or otherwise, the Company shall give written notice thereof to Warrantholder and permit Warrantholder to include any or all of the shares of Common Stock issuable upon exercise of this Warrant (and any or all shares previously issued to Warrantholder upon any prior exercise(s) hereof) in such registration on a pari passu basis with such other stockholder(s) and on the same terms and conditions applicable to such other stockholder(s).
 
(h)      Information Rights.  At all times (if any) prior to the earlier to occur of (x) the date on which all shares of Common Stock issued on exercise of this Warrant have been sold, or (y) the expiration or earlier termination of this Warrant, when the Company shall not be required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended (the “1934 Act”), Warrantholder shall be entitled to the information rights contained in Section 7.1(b) – (f) of the Loan Agreement, and in any such event Section 7.1(b) – (f) of the Loan Agreement is hereby incorporated into this Agreement by this reference as though fully set forth herein, provided, however, that the Company shall not be required to deliver a Compliance Certificate once all Indebtedness (as defined in the Loan Agreement) owed by the Company to Warrantholder has been repaid.
 
 
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(i)      Rule 144 Compliance.  The Company shall, at all times prior to the earlier to occur of (x) the date of sale or other disposition by Warrantholder of this Warrant or all shares of Common Stock issued on exercise of this Warrant, (y) the registration pursuant to subsection (g) above of the shares issued on exercise of this Warrant, or (z) the expiration or earlier termination of this Warrant if the Warrant has not been exercised in full or in part on such date, use all commercially reasonable efforts to timely file all reports required under the 1934 Act and otherwise timely take all actions necessary to permit the Warrantholder to sell or otherwise dispose of this Warrant and the shares of Common Stock issued on exercise hereof pursuant to Rule 144 promulgated under the Act as amended and in effect from time to time, provided that the foregoing shall not apply in the event of a Merger Event following which the successor or surviving entity is not subject to the reporting requirements of the 1934 Act.  If the Warrantholder proposes to sell Common Stock issuable upon the exercise of this Agreement in compliance with Rule 144, then, upon Warrantholder’s written request to the Company, the Company shall furnish to the Warrantholder, within five (5) business days after receipt of such request, a written statement confirming the Company’s compliance with the filing and other requirements of such Rule.
 
 
SECTION 10.
REPRESENTATIONS AND COVENANTS OF THE WARRANTHOLDER.
 
This Agreement has been entered into by the Company in reliance upon the following representations and covenants of the Warrantholder:
 
(a)      Investment Purpose.  This Warrant and the shares issued on exercise hereof will be acquired for investment and not with a view to the sale or distribution of any part thereof in violation of applicable federal and state securities laws, and the Warrantholder has no present intention of selling or engaging in any public distribution of the same except pursuant to a registration or exemption.
 
(b)      Private Issue.  The Warrantholder understands (i) that the Common Stock issuable upon exercise of this Agreement is not, as of the Effective Date, registered under the Act or qualified under applicable state securities laws, and (ii) that the Company's reliance on exemption from such registration is predicated on the representations set forth in this Section 10.
 
(c)      Financial Risk.  The Warrantholder has such knowledge and experi­ence in financial and business matters as to be capable of evaluating the merits and risks of its investment, and has the ability to bear the economic risks of its investment.
 
(d)      Accredited Investor.  Warrantholder is an "accredited investor" within the meaning of Rule 501 of Regulation D promulgated under the Act, as presently in effect, and Warrantholder is knowledgeable, sophisticated and experienced in making, and is qualified to make decisions with respect to, investments in shares presenting an investment decision like that involved in the purchase of the Common Stock and the Warrant, including investments in securities issued by the Company and investments in comparable companies, and has requested, received, reviewed and considered all information it deemed relevant in making an informed decision to purchase the Warrant.
 
(e)      No Short Sales. Warrantholder has not at any time on or prior to the Effective Date engaged in any short sales or equivalent transactions in the Common Stock. Warrantholder agrees that at all times from and after the Effective Date and on or before the expiration or earlier termination of this Warrant, it shall not engage in any short sales or equivalent transactions in the Common Stock.
 
 
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SECTION 11.
TRANSFERS.
 
Subject to compliance with applicable federal and state securities laws, this Agreement and all rights hereunder are transferable, in whole or in part, without charge to the holder hereof (except for transfer taxes) upon surrender of this Agreement properly endorsed.  Each taker and holder of this Agreement, by taking or holding the same, consents and agrees that this Agreement, when endorsed in blank, shall be deemed negotiable, and that the holder hereof, when this Agreement shall have been so endorsed and its transfer recorded on the Company’s books, shall be treated by the Company and all other persons dealing with this Agreement as the absolute owner hereof for any purpose and as the person entitled to exercise the rights represented by this Agreement.  The transfer of this Agreement shall be recorded on the books of the Company upon receipt by the Company of a notice of transfer in the form attached hereto as Exhibit III (the "Transfer Notice"), at its principal offices and the payment to the Company of all transfer taxes and other governmental charges imposed on such transfer.  Until the Company receives such Transfer Notice, the Company may treat the registered owner hereof as the owner for all purposes.

 
SECTION 12.
MISCELLANEOUS.
 
(a)      Effective Date.  The provisions of this Agreement shall be construed and shall be given effect in all respects as if it had been executed and delivered by the Company on the date hereof.  This Agreement shall be binding upon any successors or assigns of the Company.
 
(b)      Remedies.  In the event of any default hereunder, the non-defaulting party may proceed to protect and enforce its rights either by suit in equity and/or by action at law, including but not limited to an action for damages as a result of any such default, and/or an action for specific performance for any default where Warrantholder will not have an adequate remedy at law and where damages will not be readily ascertainable.
 
(c)      No Impairment of Rights.  The Company will not, by amendment of its Charter or through any other means, avoid or seek to avoid the observance or performance of any of the terms of this Agreement, but will at all times in good faith assist in the carrying out of all such terms and in the taking of all such actions as may be necessary or appropriate in order to protect the rights of the Warrantholder against impairment.
 
(d)      [Intentionally Omitted]
 
(e)      Attorneys’ Fees.  In any litigation, arbitration or court proceeding between the Company and the Warrantholder relating hereto, the prevailing party shall be entitled to attorneys’ fees and expenses and all costs of proceedings incurred in enforcing this Agreement.  For the purposes of this Section 12(e), attorneys’ fees shall include without limitation fees incurred in connection with the following: (i) contempt proceedings; (ii) discovery; (iii) any motion, proceeding or other activity of any kind in connection with an insolvency proceeding; (iv) garnishment, levy, and debtor and third party examinations; and (v) post-judgment motions and proceedings of any kind, including without limitation any activity taken to collect or enforce any judgment.
 
(f)      Severability.  In the event any one or more of the provisions of this Agreement shall for any reason be held invalid, illegal or unenforceable, the remaining provisions of this Agreement shall be unimpaired, and the invalid, illegal or unenforceable provision shall be replaced by a mutually acceptable valid, legal and enforceable provision, which comes closest to the intention of the parties underlying the invalid, illegal or unenforceable provision.
 
 
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(g)      Notices.  Except as otherwise provided herein, any notice, demand, request, consent, approval, declaration, service of process or other communication that is required, contemplated, or permitted under this Agreement or with respect to the subject matter hereof shall be in writing, and shall be deemed to have been validly served, given, delivered, and received upon the earlier of: (a) personal delivery to the party to be notified, (b) when sent by confirmed telex, electronic transmission or facsimile if sent during normal business hours of the recipient, if not, then on the next business day, (c) five days after having been sent by registered or certified mail, return receipt requested, postage prepaid, or (d) one day after deposit with a nationally recognized overnight courier, specifying next day delivery, with written verification of receipt, and shall be addressed to the party to be notified as follows:
 
If to Warrantholder:
 
HERCULES TECHNOLOGY II, L.P.
Legal Department
Attention:  Chief Legal Officer and Manuel Henriquez
400 Hamilton Avenue, Suite 310
Palo Alto, CA 94301
Facsimile:  650-473-9194
Telephone:  650-289-3060

If to the Company:
 
CLEVELAND BIOLABS, INC.
Attention: Chief Financial Officer
73 High Street
Buffalo, NY 14203
Facsimile:
Telephone: 716-849-6810
 
or to such other address as each party may designate for itself by like notice.
 
(h)      Entire Agreement; Amendments.  This Agreement constitutes the entire agreement and understanding of the parties hereto in respect of the subject matter hereof, and supersedes and replaces in their entirety any prior proposals, term sheets, letters, negotiations or other documents or agreements, whether written or oral, with respect to the subject matter hereof.  None of the terms of this Agreement may be amended except by an instrument executed by each of the parties hereto.
 
(i)      Headings.  The various headings in this Agreement are inserted for convenience only and shall not affect the meaning or interpretation of this Agreement or any provisions hereof.
 
(j)      Advice of Counsel.  Each of the parties represents to each other party hereto that it has discussed (or had an opportunity to discuss) with its counsel this Agreement and, specifically, the provisions of Sections 12(n), 12(o), 12(p), 12(q) and 12(r).
 
(k)      No Strict Construction.  The parties hereto have participated jointly in the negotiation and drafting of this Agreement.  In the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the parties hereto and no presumption or burden of proof shall arise favoring or disfavoring any party by virtue of the authorship of any provisions of this Agreement.
 
 
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(l)        No Waiver.  No omission or delay by Warrantholder at any time to enforce any right or remedy reserved to it, or to require performance of any of the terms, covenants or provisions hereof by Warrantholder at any time designated, shall be a waiver of any such right or remedy to which Warrantholder is entitled, nor shall it in any way affect the right of Warrantholder to enforce such provisions thereafter during the term of this Agreement.
 
(m)     Survival.  All agreements, representations and warranties contained in this Agreement or in any document delivered pursuant hereto shall be for the benefit of Warrantholder and shall survive the execution and delivery of this Agreement and the expiration or other termination of this Agreement.
 
(n)      Governing Law.  This Agreement has been negotiated and delivered to Warrantholder in the State of California, and shall be deemed to have been accepted by Warrantholder in the State of California.  Delivery of Common Stock to Warrantholder by the Company under this Agreement is due in the State of California.  This Agreement shall be governed by, and construed and enforced in accordance with, the laws of the State of California, excluding conflict of laws principles that would cause the application of laws of any other jurisdiction.
 
(o)      Consent to Jurisdiction and Venue.  All judicial proceedings arising in or under or related to this Agreement may be brought in any state or federal court of competent jurisdiction located in the State of California.  By execution and delivery of this Agreement, each party hereto generally and unconditionally: (a) consents to personal jurisdiction in Santa Clara County, State of California; (b) waives any objection as to jurisdiction or venue in Santa Clara County, State of California; (c) agrees not to assert any defense based on lack of jurisdiction or venue in the aforesaid courts; and (d) irrevocably agrees to be bound by any judgment rendered thereby in connection with this Agreement.  Service of process on any party hereto in any action arising out of or relating to this Agreement shall be effective if given in accordance with the requirements for notice set forth in Section 12(g), and shall be deemed effective and received as set forth in Section 12(g).  Nothing herein shall affect the right to serve process in any other manner permitted by law or shall limit the right of either party to bring proceedings in the courts of any other jurisdiction.
 
(p)      Mutual Waiver of Jury Trial.  Because disputes arising in connection with complex financial transactions are most quickly and economically resolved by an experienced and expert person and the parties wish applicable state and federal laws to apply (rather than arbitration rules), the parties desire that their disputes arising under or in connection with this Warrant be resolved by a judge applying such applicable laws.  EACH OF THE COMPANY AND WARRANTHOLDER SPECIFICALLY WAIVES ANY RIGHT IT MAY HAVE TO TRIAL BY JURY OF ANY CAUSE OF ACTION, CLAIM, CROSS-CLAIM, COUNTERCLAIM, THIRD PARTY CLAIM OR ANY OTHER CLAIM (COLLECTIVELY, "CLAIMS") ASSERTED BY THE COMPANY AGAINST WARRANTHOLDER OR ITS ASSIGNEE OR BY WARRANTHOLDER OR ITS ASSIGNEE AGAINST THE COMPANY RELATING TO THIS WARRANT.  This waiver extends to all such Claims, including Claims that involve persons or entities other the Company and Warrantholder; Claims that arise out of or are in any way connected to the relationship between the Company and Warrantholder; and any Claims for damages, breach of contract, specific performance, or any equitable or legal relief of any kind, arising out of this Agreement.
 
(q)      Arbitration.  If the Mutual Waiver of Jury Trial set forth in Section 12(p) is ineffective or unenforceable, the parties agree that all Claims shall be submitted to binding arbitration in accordance with the commercial arbitration rules of JAMS (the “Rules”), such arbitration to occur before one arbitrator, which arbitrator shall be a retired California state judge or a retired Federal court judge.  Such proceeding shall be conducted in Santa Clara County, State of California, with California rules of evidence and discovery applicable to such arbitration.  The decision of the arbitrator shall be binding on the parties, and shall be final and nonappealable to the maximum extent permitted by law.  Any judgment rendered by the arbitrator may be entered in a court of competent jurisdiction and enforced by the prevailing party as a final judgment of such court.
 
 
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(r)      Pre-arbitration Relief.  In the event Claims are to be resolved by arbitration, either party may seek from a court of competent jurisdiction identified in Section 12(o), any prejudgment order, writ or other relief and have such prejudgment order, writ or other relief enforced to the fullest extent permitted by law notwithstanding that all Claims are otherwise subject to resolution by binding arbitration.
 
(s)      Counterparts.  This Agreement and any amendments, waivers, consents or supplements hereto may be executed in any number of counterparts, and by different parties hereto in separate counterparts, each of which when so delivered shall be deemed an original, but all of which counterparts shall constitute but one and the same instrument.
 
(t)      Lost, Stolen, Mutilated or Destroyed Warrant.  If this Warrant is lost, stolen, mutilated or destroyed, the Company may, on such terms as to indemnity or otherwise as it may reasonably impose (which shall, in the case of a mutilated Warrant, include the surrender thereof), issue a new Warrant of like denomination and tenor as this Warrant so lost, stolen, mutilated or destroyed.  Any such new Warrant shall constitute an original contractual obligation of the Company, whether or not the allegedly lost, stolen, mutilated or destroyed Warrant shall be at any time enforceable by anyone.
 
(u)      Legends.  To the extent required by applicable laws, this Warrant and the shares of Common Stock issuable hereunder (and the securities issuable, directly or indirectly, upon conversion of such shares of Common Stock, if any) may be imprinted with a restricted securities legend in substantially the following form:

THIS SECURITY HAS NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR ANY APPLICABLE STATE SECURITIES LAWS, AND MAY NOT BE SOLD, PLEDGED OR OTHERWISE TRANSFERRED WITHOUT AN EFFECTIVE REGISTRATION THEREOF UNDER THE ACT AND ANY APPLICABLE STATE SECURITIES LAWS, OR PURSUANT TO RULE 144 OR AN EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THE ACT AND ANY APPLICABLE STATE SECURITIES LAWS.
 
 
[Remainder of Page Intentionally Left Blank]

 
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IN WITNESS WHEREOF, the parties hereto have caused this Warrant Agreement to be executed by its officers thereunto duly authorized as of the Effective Date.


COMPANY:                                           CLEVELAND BIOLABS, INC.


By:           /s/ C. Neil Lyons
Name:      C. Neil Lyons
Title:        Chief Financial Officer



WARRANTHOLDER:
HERCULES TECHNOLOGY II L.P.,
a Delaware limited partnership
 
By: Hercules Technology SBIC Management, LLC,
its General Partner
 
By: Hercules Technology Growth Capital, Inc.,
its Manager
 
 
By: /s/ K. Nicholas Martitsch
 
Name: K. Nicholas Martitsch
Title: Associate General Counsel

 
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EXHIBIT  I

NOTICE  OF  EXERCISE


To:           [____________________________]

(1)
The undersigned Warrantholder hereby elects to purchase [_______] shares of the Common Stock of [_________________], pursuant to the terms of the Agreement dated the [___] day of [______, _____] (the "Agreement") between [_________________] and the Warrantholder, and tenders herewith payment of the Purchase Price in full, together with all applicable transfer taxes, if any. [NET ISSUANCE: elects pursuant to Section 3(a) of the Agreement to effect a Net Issuance.]

(2)
Please issue a certificate or certificates representing said shares of Common Stock in the name of the undersigned or in such other name as is specified below.



_________________________________
(Name)

_________________________________
(Address)


WARRANTHOLDER:
HERCULES TECHNOLOGY II L.P.,
a Delaware limited partnership
 
By: Hercules Technology SBIC Management, LLC,
its General Partner
 
 
By: Hercules Technology Growth Capital, Inc.,
its Manager
 
By: ___________________________
Name: K. Nicholas Martitsch
Title: Associate General Counsel


 
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EXHIBIT II

1.
ACKNOWLEDGMENT OF EXERCISE
 

The undersigned [____________________________________], hereby acknowledge receipt of the "Notice of Exercise" from Hercules Technology Growth Capital, Inc., to purchase [____] shares of the Common Stock of [_________________], pursuant to the terms of the Agreement, and further acknowledges that [______] shares remain subject to purchase under the terms of the Agreement.



COMPANY:                                                      [_________________]


By:           ________________________________
 
Title:           ________________________________
 
Date:           ________________________________
 
 
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EXHIBIT III

TRANSFER NOTICE


(To transfer or assign the foregoing Agreement execute this form and supply required information.  Do not use this form to purchase shares.)

FOR VALUE RECEIVED, the foregoing Agreement and all rights evidenced thereby are hereby transferred and assigned to

_________________________________________________________________
(Please Print)

whose address is___________________________________________________

_________________________________________________________________


Dated:           ___________________________________
 
Holder's Signature:     ____________________________
 
Holder's Address:       ____________________________
 
_____________________________________________


Signature Guaranteed:        ____________________________________________


NOTE:                      The signature to this Transfer Notice must correspond with the name as it appears on the face of the Agreement, without alteration or enlargement or any change whatever. Officers of corporations and those acting in a fiduciary or other representative capacity should file proper evidence of authority to assign the foregoing Agreement.

 
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EX-10.3 3 exh_103.htm EXHIBIT 10.3 exh_103.htm
Exhibit 10.3
 
LOAN AND SECURITY AGREEMENT
 
THIS LOAN AND SECURITY AGREEMENT is made and dated as of September 30, 2013 and is entered into by and among (a) (i) CLEVELAND BIOLABS, INC., a Delaware corporation (“Inc”) and (ii) BIOLAB 612, LLC, a limited liability company formed in the Russian Federation (“LLC”) (Inc and LLC hereinafter individually and collectively referred to as the “Borrower”), and (b) HERCULES TECHNOLOGY II, L.P., a Delaware limited partnership (“Lender”).
 
RECITALS
 
A.           Borrower has requested Lender to make available to Borrower two (2) term loans (each a “Term Loan Advance” and collectively, the “Term Loan Advances”) in an aggregate principal amount of up to Ten Million Dollars ($10,000,000) (the “Maximum Term Loan Amount”); and
 
B.           Lender is willing to make the Term Loan Advances on the terms and conditions set forth in this Agreement.
 
AGREEMENT
 
NOW, THEREFORE, Borrower and Lender agree as follows:
 
SECTION 1.  DEFINITIONS AND RULES OF CONSTRUCTION
 
1.1           Unless otherwise defined herein, the following capitalized terms shall have the following meanings:
 
Account Control Agreement(s)” means any agreement entered into by and among the Lender, Borrower and a third party Bank or other institution (including a Securities Intermediary) in which Borrower maintains a Deposit Account or an account holding Investment Property and which grants Lender a perfected first priority security interest in the subject account or accounts.
 
ACH Authorization” means the ACH Debit Authorization Agreement in substantially the form of Exhibit H to the Disclosure Letter.
 
Advance(s)” means a Term Loan Advance.
 
Advance Date” means the funding date of any Advance.
 
Advance Request” means a request for an Advance submitted by Borrower to Lender in substantially the form of Exhibit A to the Disclosure Letter.
 
Agreement” means this Loan and Security Agreement, as amended from time to time.
 
Amortization Date” means November 1, 2014.
 
Assignee” has the meaning given to it in Section 11.13.
 
Borrower Products” means all products, software, service offerings, technical data or technology currently being designed, manufactured or sold by Borrower or which Borrower intends to sell, license, or distribute in the future including any products or service offerings under development, collectively, together with all products, software, service offerings, technical data or technology that have been sold, licensed or distributed by Borrower since its incorporation.
 
Business Day” is any day that is not a Saturday, Sunday or a day on which Lender is closed.
 
 
 

 
Cash” means all cash and liquid funds.
 
Change in Control” means any reorganization, recapitalization, consolidation or merger (or similar transaction or series of related transactions) of Borrower, sale or exchange of outstanding shares (or similar transaction or series of related transactions) of Borrower in which the holders of Borrower outstanding shares immediately before consummation of such transaction or series of related transactions do not, immediately after consummation of such transaction or series of related transactions, retain shares representing more than fifty percent (50%) of the voting power of the surviving entity of such transaction or series of related transactions (or the parent of such surviving entity if such surviving entity is wholly owned by such parent), in each case without regard to whether Borrower is the surviving entity.
 
Claims” has the meaning given to it in Section 11.10.
 
Closing Date” means the date of this Agreement.
 
Collateral” means the property described in Section 3.
 
 “Common Stock” means Inc’s common stock, $0.005 par value per share, and any class or series of Inc’s capital stock into or for which such common stock may be converted, exchanged or substituted pursuant to a reorganization, recapitalization, exchange offer or otherwise.
 
 “Confidential Information” has the meaning given to it in Section 11.12.
 
Contingent Obligation” means, as applied to any Person, any direct or indirect liability, contingent or otherwise, of that Person with respect to (i) any indebtedness, lease, dividend, letter of credit or other obligation of another, including any such obligation directly or indirectly guaranteed, endorsed, co-made or discounted or sold with recourse by that Person, or in respect of which that Person is otherwise directly or indirectly liable; (ii) any obligations with respect to undrawn letters of credit, corporate credit cards or merchant services issued for the account of that Person; and (iii) all obligations arising under any interest rate, currency or commodity swap agreement, interest rate cap agreement, interest rate collar agreement, or other agreement or arrangement designated to protect a Person against fluctuation in interest rates, currency exchange rates or commodity prices; provided, however, that the term “Contingent Obligation” shall not include endorsements for collection or deposit in the ordinary course of business.  The amount of any Contingent Obligation shall be deemed to be an amount equal to the stated or determined amount of the primary obligation in respect of which such Contingent Obligation is made or, if not stated or determinable, the maximum reasonably anticipated liability in respect thereof as determined by such Person in good faith; provided, however, that such amount shall not in any event exceed the maximum amount of the obligations under the guarantee or other support arrangement.
 
Copyright License” means any written agreement granting any right to use any Copyright or Copyright registration, now owned or hereafter acquired by Borrower or in which Borrower now holds or hereafter acquires any interest.
 
Copyrights” means all copyrights, whether registered or unregistered, held pursuant to the laws of the United States, any State thereof, or of any other country.
 
Deposit Accounts” means any “deposit accounts,” as such term is defined in the UCC, and includes any checking account, savings account, or certificate of deposit.
 
Disclosure Letter” means that certain Disclosure Letter dated as of even date herewith between Borrower and Lender.
 
Draw Period” means the period commencing upon the occurrence of the Milestone Event and ending on the earlier to occur of (i) June 30, 2014, and (ii) an Event of Default.
 
End of Term Charge” is defined in Section 2.5
 
 
 

 
ERISA” is the Employee Retirement Income Security Act of 1974, and its regulations.
 
Event of Default” has the meaning given to it in Section 9.
 
Excluded Accounts” means any zero balance accounts and accounts of LLC located outside of the United States.
 
Facility Charge” means one percent (1%) of the Maximum Term Loan Amount.
 
Financial Statements” has the meaning given to it in Section 7.1.
 
 “GAAP” means generally accepted accounting principles in the United States of America, as in effect from time to time.
 
Inc” defined in the preamble of the Agreement.
 
Indebtedness” means indebtedness of any kind, including (a) all indebtedness for borrowed money or the deferred purchase price of property or services (excluding trade credit entered into in the ordinary course of business due within sixty (60) days), including reimbursement and other obligations with respect to surety bonds and letters of credit, (b) all obligations evidenced by notes, bonds, debentures or similar instruments, (c) all capital lease obligations, and (d) all Contingent Obligations.
 
Insolvency Proceeding” is any proceeding by or against any Person under the United States Bankruptcy Code, or any other bankruptcy or insolvency law, including assignments for the benefit of creditors, compositions, extensions generally with its creditors, or proceedings seeking reorganization, arrangement, or other relief.
 
Intellectual Property” means all of Borrower’s Copyrights; Trademarks; Patents; Licenses; trade secrets and inventions; mask works; Borrower’s applications therefor and reissues, extensions, or renewals thereof; and Borrower’s goodwill associated with any of the foregoing, together with Borrower’s rights to sue for past, present and future infringement of Intellectual Property and the goodwill associated therewith.
 
Investment” means any beneficial ownership (including stock, partnership or limited liability company interests) of or in any Person, or any loan, advance or capital contribution to any Person or the acquisition of all, or substantially all, of the assets of another Person.
 
Joinder Agreements” means for each Subsidiary, a completed and executed Joinder Agreement in substantially the form attached hereto as Exhibit G.
 
Lender” has the meaning given to it in the preamble to this Agreement.
 
 “License” means any Copyright License, Patent License, Trademark License or other license of rights or interests.
 
Lien” means any mortgage, deed of trust, pledge, hypothecation, assignment for security, security interest, encumbrance, levy, lien or charge of any kind, whether voluntarily incurred or arising by operation of law or otherwise, against any property, any conditional sale or other title retention agreement, and any lease in the nature of a security interest.
 
LLC” defined in the preamble of this Agreement.
 
Loan” means the Advances made under this Agreement.
 
Loan Documents” means this Agreement, the Notes (if any), the ACH Authorization, the Pledge Agreement, the Account Control Agreements, the Joinder Agreements, all UCC Financing Statements, the Warrant, the Disclosure Letter, and any other documents executed in connection with the Secured Obligations or the transactions contemplated hereby, as the same may from time to time be amended, modified, supplemented or restated.
 
 
 

 
Material Adverse Effect” means a material adverse effect upon: (i) the business, operations, properties, assets, or condition (financial or otherwise) of Borrower; or (ii) the ability of Borrower to perform the Secured Obligations in accordance with the terms of the Loan Documents, or the ability of Lender to enforce any of its rights or remedies with respect to the Secured Obligations; or (iii) the Collateral or Lender’s Liens on the Collateral or the priority of such Liens.
 
 “Maximum Term Loan Amount” shall have the meaning assigned to such term in the preamble to this Agreement.
 
Maximum Rate” shall have the meaning assigned to such term in Section 2.2.
 
Milestone Event” means (a) Borrower has delivered evidence acceptable to Lender in Lender’s reasonable discretion that Borrower has received a Biomedical Advanced Research and Development Authority contract award or such other funding sufficient to fund the base contract proposal for a series of studies of Entolimod (CBLB502) as a radiation countermeasure, which studies shall be structured in such a manner that their completion and resulting data would reasonably be expected to provide a basis for submitting a Biological License Application to the United States Food and Drug Administration for licensure of Entolimod (CBLB502) as a radiation countermeasure, and (b) Lender has reviewed and accepted, in Lender’s reasonable discretion, the plan and funding relating to such studies.
 
Note(s)” means a promissory note or promissory notes to evidence Lender’s Loans.
 
Patent License” means any written agreement granting any right with respect to any invention on which a Patent is in existence or a Patent application is pending, in which agreement Borrower now holds or hereafter acquires any interest.
 
Patents” means all letters patent of, or rights corresponding thereto, in the United States or in any other country, all registrations and recordings thereof, and all applications for letters patent of, or rights corresponding thereto, in the United States or any other country.
 
Permitted Indebtedness” means: (i) Indebtedness of Borrower in favor of Lender arising under this Agreement or any other Loan Document; (ii) Indebtedness existing on the Closing Date which is disclosed in Schedule 1A to the Disclosure Letter; (iii) Indebtedness of up to $250,000 outstanding at any time secured by a Lien described in clause (vii) of the defined term “Permitted Liens,” provided such Indebtedness does not exceed the lesser of the cost or fair market value of the Equipment financed with such Indebtedness; (iv) Indebtedness to trade creditors incurred in the ordinary course of business, including Indebtedness incurred in the ordinary course of business with corporate credit cards; (v) Indebtedness that also constitutes a Permitted Investment; (vi) Subordinated Indebtedness; (vii) reimbursement obligations in connection with letters of credit that are secured by cash or cash equivalents and issued on behalf of the Borrower or a Subsidiary thereof in an amount not to exceed $200,000 at any time outstanding, (viii) guarantees or other Contingent Obligations required to be made as credit support in connection with obtaining grants for Borrower or any Subsidiary, (ix) Indebtedness incurred in connection with obtaining funds that are to be pledged as required in connection with obtaining grants for Borrower or any Subsidiary, (x) other Indebtedness in an amount not to exceed $150,000 at any time outstanding, and (xi) extensions, refinancings and renewals of any items of Permitted Indebtedness, provided that the principal amount is not increased or the terms modified to impose materially more burdensome terms upon Borrower or its Subsidiary, as the case may be.
 
 
 

 
Permitted Investment” means: (i) Investments existing on the Closing Date which are disclosed in Schedule 1B to the Disclosure Letter; (ii) (a) marketable direct obligations issued or unconditionally guaranteed by the United States of America or any agency or any State thereof maturing within one year from the date of acquisition thereof, (b) commercial paper maturing no more than one year from the date of creation thereof and currently having a rating of at least A-2 or P-2 from either Standard & Poor’s Corporation or Moody’s Investors Service, (c) certificates of deposit issued by any bank with assets of at least $500,000,000 maturing no more than one year from the date of investment therein, and (d) money market accounts; (iii) repurchases of stock from former employees, directors, or consultants of Borrower under the terms of applicable repurchase agreements at the original issuance price of such securities in an aggregate amount not to exceed $250,000 in any fiscal year, provided that no Event of Default has occurred, is continuing or would exist after giving effect to the repurchases; (iv) Investments accepted in connection with Permitted Transfers; (v) Investments (including debt obligations) received in connection with the bankruptcy or reorganization of customers or suppliers and in settlement of delinquent obligations of, and other disputes with, customers or suppliers arising in the ordinary course of Borrower’s business; (vi) Investments consisting of notes receivable of, or prepaid royalties and other credit extensions, to customers and suppliers who are not affiliates, in the ordinary course of business, provided that this subparagraph (vi) shall not apply to Investments of Borrower in any Subsidiary; (vii) Investments consisting of loans not involving the net transfer on a substantially contemporaneous basis of cash proceeds to employees, officers or directors relating to the purchase of capital stock of Borrower pursuant to employee stock purchase plans or other similar agreements approved by Borrower’s Board of Directors; (viii) Investments consisting of travel advances and employee relocation advances in the ordinary course of business; (ix) Investments in newly-formed Subsidiaries organized in the United States, provided that such Subsidiaries enter into a Joinder Agreement promptly after their formation by  Borrower and execute such other documents as shall be reasonably requested by Lender; (x) Investments in subsidiaries organized within or outside of the United States approved in advance in writing by Lender; (xi) Investments in other Subsidiaries, provided that any cash Investments by Borrower do not exceed $100,000 in the aggregate in any fiscal year; (xii) joint ventures or strategic alliances in the ordinary course of Borrower’s business consisting of the nonexclusive licensing of technology, the development of technology or the providing of technical support, provided that any cash Investments by Borrower do not exceed $100,000 in the aggregate in any fiscal year; (xiii) Investments acquired pursuant to the exercise of warrants in existence on the Closing Date and disclosed to Lender in Schedule 1B to the Disclosure Letter, and (xiv) additional Investments that do not exceed $250,000 in the aggregate.
 
Permitted Liens” means any and all of the following: (i) Liens in favor of Lender; (ii) Liens existing on the Closing Date which are disclosed in Schedule 1C to the Disclosure Letter; (iii) Liens for taxes, fees, assessments or other governmental charges or levies, either not delinquent or being contested in good faith by appropriate proceedings; provided, that Borrower maintains adequate reserves therefor in accordance with GAAP to the extent required thereby; (iv) Liens securing claims or demands of materialmen, artisans, mechanics, carriers, warehousemen, landlords and other like Persons arising in the ordinary course of Borrower’s business and imposed without action of such parties which are not delinquent; (v) Liens arising from judgments, decrees or attachments in circumstances which do not constitute an Event of Default hereunder; (vi) the following deposits, to the extent made in the ordinary course of business:  deposits under worker’s compensation, unemployment insurance, social security and other similar laws, or to secure the performance of bids, tenders or contracts (other than for the repayment of borrowed money) or to secure indemnity, performance or other similar bonds for the performance of bids, tenders or contracts (other than for the repayment of borrowed money) or to secure statutory obligations (other than liens arising under ERISA or environmental liens) or surety or appeal bonds, or to secure indemnity, performance or other similar bonds; (vii) Liens on Equipment or software or other intellectual property constituting purchase money liens and liens in connection with capital leases securing Indebtedness permitted in clause (iii) of “Permitted Indebtedness”;  (viii) Liens incurred in connection with Subordinated Indebtedness; (ix) leasehold interests in leases or subleases and licenses granted in the ordinary course of business and not interfering in any material respect with the business of the licensor; (x) Liens in favor of customs and revenue authorities arising as a matter of law to secure payment of custom duties that are promptly paid on or before the date they become due; (xi) Liens on insurance proceeds securing the payment of financed insurance premiums that are promptly paid on or before the date they become due (provided that such Liens extend only to such insurance proceeds and not to any other property or assets); (xii) statutory and common law rights of set-off and other similar rights as to deposits of cash and securities in favor of banks, other depository institutions and brokerage firms; (xiii) easements, zoning restrictions, rights-of-way and similar encumbrances on real property imposed by law or arising in the ordinary course of business so long as they do not materially impair the value or marketability of the related property; (xiv) Liens on cash or cash equivalents securing obligations permitted under clause (vii) of the definition of Permitted Indebtedness; and (xv) Liens arising from pledges of cash, letters of credit or other collateral required to be made in connection with obtaining grants for Borrower or any Subsidiary; (xvi) Liens on cash or bank letters of credit securing Indebtedness permitted in clause (ix) of “Permitted Indebtedness”; and (xvii) Liens incurred in connection with the extension, renewal or refinancing of the indebtedness secured by Liens of the type described in clauses (i) through (xi) above; provided, that any extension, renewal or replacement Lien shall be limited to the property encumbered by the existing Lien and the principal amount of the indebtedness being extended, renewed or refinanced (as may have been reduced by any payment thereon) does not increase.
 
 
 

 
Permitted Transfers” means (i) sales of Inventory in the normal course of business, (ii) licenses and similar arrangements for the use of Intellectual Property in the ordinary course of business that could not result in a legal transfer of title of the licensed property, or (iii) dispositions of worn-out, obsolete or surplus Equipment in the ordinary course of business, and (iv) Transfers in connection with Permitted Investments, (v) sales of Borrower’s equity securities provided that no Change in Control occurs as a result thereof, (vi) dispositions expressly permitted under Section 7.6, 7.7 or 7.9 hereof, (vii) dispositions arising from the abandonment of fixtures and other similar tenant improvements in connection with office relocations, and (viii) other Transfers of assets having a fair market value of not more than $250,000 in the aggregate in any fiscal year.
 
Person” means any individual, sole proprietorship, partnership, joint venture, trust, unincorporated organization, association, corporation, limited liability company, institution, other entity or government.
 
Pledge Agreement” means that certain Stock Pledge Agreements dated as of the Closing Date executed by Inc in favor of Lender.
 
 “Prepayment Charge” shall have the meaning assigned to such term in Section 2.4.
 
Prime Rate” means the “prime rate” as reported in The Wall Street Journal, and if not reported, then the prime rate most recently reported in The Wall Street Journal.
 
 “Receivables” means (i) all of Borrower’s Accounts, Instruments, Documents, Chattel Paper, Supporting Obligations, letters of credit, proceeds of any letter of credit, and Letter of Credit Rights, and (ii) all customer lists, software, and business records related thereto.
 
SBA” shall have the meaning assigned to such term in Section 7.14.
 
SBIC” shall have the meaning assigned to such term in Section 7.14.
 
SBIC Act” shall have the meaning assigned to such term in Section 7.14.
 
SEC” means the United States Securities and Exchange Commission or any governmental authority that may be substituted therefor.
 
Secured Obligations” means Borrower’s obligations under this Agreement and any Loan Document, including any obligation to pay any amount now owing or later arising.  Notwithstanding the foregoing, the “Secured Obligations” shall not include any of Borrower’s obligations, liabilities or duties under the Warrant.
 
Subordinated Indebtedness” means Indebtedness subordinated to the Secured Obligations in amounts and on terms and conditions satisfactory to Lender in its sole discretion.
 
Subsequent Financing” means any sale and issuance by Borrower on or after the date hereof and prior to expiration or earlier termination of this Agreement, in a single transaction or series of related transactions not registered under the Securities Act of 1933, as amended, of shares of its preferred stock, common stock or other equity security, or of any instrument exercisable for or convertible into or otherwise representing the right to acquire shares of Borrower preferred stock, common stock or other equity security, to one or more investors for cash for financing purposes (also known as a PIPE transaction), which offering by Borrower is broadly marketed to multiple investors.
 
Subsidiary” means an entity, whether corporate, partnership, limited liability company, joint venture or otherwise, in which Borrower owns or controls more than 50% of the outstanding voting securities, including each entity listed in Schedule 1 to the Disclosure Letter.
 
 
 

 
Term Loan Advance” and “Term Loan Advances” are each defined in Recital A hereof.
 
 “Term Loan Interest Rate” means for any day, a floating rate per annum rate equal to the greater of either (i) ten and forty-five hundredths of one percent (10.45%), or (ii) the sum of (A) ten and forty-five hundredths of one percent (10.45%), plus (B) the Prime Rate minus four and one quarter of one percent (4.25%).  The Term Loan Interest Rate will change from time to time on the day the Prime Rate changes.
 
Term Loan Maturity Date” means January 1, 2017.
 
Trademark License” means any written agreement granting any right to use any Trademark or Trademark registration, now owned or hereafter acquired by Borrower or in which Borrower now holds or hereafter acquires any interest.
 
Trademarks” means all trademarks (registered, common law or otherwise) and any applications in connection therewith, including registrations, recordings and applications in the United States Patent and Trademark Office or in any similar office or agency of the United States, any State thereof or any other country or any political subdivision thereof.
 
UCC” means the Uniform Commercial Code as the same is, from time to time, in effect in the State of California; provided, that in the event that, by reason of mandatory provisions of law, any or all of the attachment, perfection or priority of, or remedies with respect to, Lender’s Lien on any Collateral is governed by the Uniform Commercial Code as the same is, from time to time, in effect in a jurisdiction other than the State of California, then the term “UCC” shall mean the Uniform Commercial Code as in effect, from time to time, in such other jurisdiction solely for purposes of the provisions thereof relating to such attachment, perfection, priority or remedies and for purposes of definitions related to such provisions.
 
 “Warrant” means the warrant entered into in connection with the Loan.
 
Unless otherwise specified, all references in this Agreement or any Annex or Schedule hereto to a “Section,” “subsection,” “Exhibit,” “Annex,” or “Schedule” shall refer to the corresponding Section, subsection, Exhibit, Annex, or Schedule in or to this Agreement.  Unless otherwise specifically provided herein, any accounting term used in this Agreement or the other Loan Documents shall have the meaning customarily given such term in accordance with GAAP, and all financial computations hereunder shall be computed in accordance with GAAP, consistently applied. Unless otherwise defined herein or in the other Loan Documents, terms that are used herein or in the other Loan Documents and defined in the UCC shall have the meanings given to them in the UCC.
 
SECTION 2.  THE LOAN
 
2.1           Term Loan.
 
(a)           Advances.  Subject to the terms and conditions of this Agreement, Lender will make, and Borrower agrees to draw, an initial Term Loan Advance in the amount of Six Million Dollars ($6,000,000) on the Closing Date. During the Draw Period, Borrower may request one (1) additional Term Loan Advance in an amount of Four Million Dollars ($4,000,000).  The aggregate outstanding Term Loan Advances shall not exceed the Maximum Term Loan Amount.  Proceeds of any Advance shall be deposited into an account that is subject to a perfected security interest in favor of Lender perfected by a control agreement.
 
(b)           Advance Request.  To obtain a Term Loan Advance, Borrower shall complete, sign and deliver to Lender an Advance Request (at least five (5) Business Days before the Advance Date or such lesser time period agreed to by Lender).  Lender shall fund the Term Loan Advance in the manner requested by the Advance Request provided that each of the conditions precedent to such Term Loan Advance is satisfied as of the requested Advance Date.
 
(c)           Interest.  The principal balance of each Term Loan Advance shall bear interest thereon from such Advance Date at the Term Loan Interest Rate based on a year consisting of 360 days, with interest computed daily based on the actual number of days elapsed.  The Term Loan Interest Rate will float and change on the day the Prime Rate changes from time to time.
 
 
 

 
(d)           Payment.  Borrower will pay interest on each Term Loan Advance on the first (1st) Business Day of each month, beginning the month after the Advance Date.  Commencing on the Amortization Date, and continuing on the first (1st) Business Day of each month thereafter, Borrower shall repay the aggregate principal balance of Term Loan Advances that are outstanding on the Amortization Date in equal monthly installments of principal and interest (mortgage style) based upon an amortization schedule equal to thirty (30) consecutive months.  The entire principal balance of the Term Loan Advances and all accrued but unpaid interest hereunder, and all other Secured Obligations with respect to the Term Loan Advances, shall be due and payable on Term Loan Maturity Date.  Borrower shall make all payments under this Agreement without setoff, recoupment or deduction and regardless of any counterclaim or defense. Lender will initiate debit entries to the Borrower’s account as authorized on the ACH Authorization on each payment date of all periodic obligations payable to Lender under each Term Loan Advance.  Once repaid, a Term Loan Advance or any portion thereof may not be reborrowed.
 
2.2           Maximum Interest.  Notwithstanding any provision in this Agreement, or any other Loan Document, it is the parties’ intent not to contract for, charge or receive interest at a rate that is greater than the maximum rate permissible by law that a court of competent jurisdiction shall deem applicable hereto (which under the laws of the State of California shall be deemed to be the laws relating to permissible rates of interest on commercial loans) (the “Maximum Rate”).  If a court of competent jurisdiction shall finally determine that Borrower has actually paid to Lender an amount of interest in excess of the amount that would have been payable if all of the Secured Obligations had at all times borne interest at the Maximum Rate, then such excess interest actually paid by Borrower shall be applied as follows:  first, to the payment of the Secured Obligations consisting of the outstanding principal of the Term Loan Advances; second, after all principal is repaid, to the payment of Lender’s accrued interest, costs, expenses, professional fees and any other Secured Obligations; and third, after all Secured Obligations are repaid, the excess (if any) shall be refunded to Borrower.
 
2.3           Default Interest.  In the event any payment is not paid on the scheduled payment date (other than non-payment of an automatically scheduled payment due to the fault of Lender), an amount equal to five percent (5%) of the past due amount shall be payable on demand. In addition, upon the occurrence and during the continuation of an Event of Default hereunder, all Secured Obligations, including principal, interest, compounded interest, and Lender’s fees and expenses set forth in Section 11.11, shall bear interest at a rate per annum equal to the rate set forth in Section 2.1(c), plus five percent (5%) per annum.  In the event any interest is not paid when due hereunder, delinquent interest shall be added to principal and shall bear interest on interest, compounded at the rate set forth in Section 2.1(c).
 
2.4           Prepayment.  At its option upon at least seven (7) Business Days prior notice to Lender, Borrower may prepay all, or any portion, of the outstanding Advances by paying the entire principal balance or a portion thereof, all accrued and unpaid interest on the portion prepaid, all unpaid Lender’s fees and expenses accrued to the date of the repayment (including in the event of a prepayment in full, the End of Term Charge), together with a prepayment charge on the portion prepaid equal to the following percentage of the Advance amount being prepaid: if such Advance amounts are prepaid in any of the first twelve (12) months following the Closing Date, three percent (3%); after twelve (12) months but prior to twenty four (24) months, two percent (2%); and after twenty four (24) months but prior to the Term Loan Maturity Date, one percent (1%) (each, a “Prepayment Charge”).  Borrower agrees that the Prepayment Charge is a reasonable calculation of Lender’s lost profits in view of the difficulties and impracticality of determining actual damages resulting from an early repayment of the Advances.  Upon the occurrence of a Change in Control, Borrower shall prepay the outstanding amount of all principal and accrued interest through the prepayment date and all unpaid Lender’s fees and expenses accrued to the date of the repayment (including the End of Term Charge) together with a Prepayment Charge.
 
2.5           End of Term Charge.  On the earliest to occur of (i) the Term Loan Maturity Date, (ii) the date that Borrower prepays all outstanding Secured Obligations, or (iii) if earlier, the date that the Secured Obligations become due and payable, Borrower shall pay Lender a charge of Five Hundred Fifty Thousand Dollars ($550,000) (the “End of Term Charge”).  Notwithstanding the required payment date of such charge, it shall be deemed earned by Lender as of the Closing Date.
 
 
 

 
2.6           Witholding. In the event any payments are received by Lender from Borrower pursuant to any Loan Document, such payments will be made subject to applicable withholding for any taxes, levies, fees, deductions, withholding, restrictions or conditions of any nature whatsoever.  Notwithstanding the foregoing, if at any time any governmental authority, applicable law, regulation or international agreement requires Borrower to make any such deduction or withholding from any such payment or other sum payment hereunder to Lender, the amount due from Borrower with respect to such payment or other sum payable hereunder will be increased to the extent necessary to ensure that, after the making of such required deduction or withholding, Lender receives a net sum equal to the sum which it would have received had no deductions or withholding been required, and Borrower shall pay the full amount deducted or withheld to the relevant governmental authority. Borrower will, upon request, furnish Lender with proof satisfactory to Lender indicating that Borrower has made such withholding payment. The agreements and obligations of Borrower contained in this provision shall survive the termination of this Agreement.
 
2.7           Notes.  If so requested by Lender by written notice to Borrower, then Borrower shall execute and deliver to Lender (and/or, if applicable and if so specified in such notice, to any person who is an assignee of Lender pursuant to Section 11.13) (promptly after the Borrower’s receipt of such notice) a Note or Notes to evidence Lender’s Loans.
 
2.8           Termination.  All of Borrower’s covenants and obligations under this Agreement (other than inchoate indemnity obligations and Lender’s investment rights pursuant to Section 8 hereof) shall terminate upon indefeasible satisfaction in full, in cash, of all amounts owing by Borrower to Lender hereunder and upon termination of Lender’s commitment to make Advances hereunder.  Upon such termination, and upon Borrower’s written request therefor, and at Borrower’s sole cost and expense, Lender shall promptly terminate all Liens in favor of Borrower.
 
SECTION 3.  SECURITY INTEREST
 
3.1           As security for the prompt, complete and indefeasible payment when due (whether on the payment dates or otherwise) of all the Secured Obligations, Borrower grants to Lender a security interest in all of Borrower’s right, title, and interest in and to the following personal property whether now owned or hereafter acquired (collectively, the “Collateral”):  (a) Receivables; (b) Equipment; (c) Fixtures; (d) General Intangibles (other than Intellectual Property); (e) Inventory; (f) Investment Property (but excluding thirty-five percent (35%) of the capital stock of any foreign Subsidiary that constitutes a Permitted Investment); (g) Deposit Accounts; (h) Cash; (i) Goods; and all other tangible and intangible personal property of Borrower whether now or hereafter owned or existing, leased, consigned by or to, or acquired by, Borrower and wherever located, and any of Borrower’s property in the possession or under the control of Lender; and, to the extent not otherwise included, all Proceeds of each of the foregoing and all accessions to, substitutions and replacements for, and rents, profits and products of each of the foregoing; provided, however, that the Collateral shall include all Accounts and General Intangibles that consist of rights to payment and proceeds from the sale, licensing or disposition of all or any part, or rights in, the Intellectual Property (the “Rights to Payment”).  Notwithstanding the foregoing, if a judicial authority (including a U.S. Bankruptcy Court) holds that a security interest in the underlying Intellectual Property is necessary to have a security interest in the Rights to Payment, then the Collateral shall automatically, and effective as of the date of this Agreement, include the Intellectual Property to the extent necessary to permit perfection of Lender’s security interest in the Rights to Payment.  Notwithstanding the foregoing, the Collateral does not include (i) Excluded Accounts, (ii) any interest of Borrower as a lessee or sublessee under a real property lease, (iii) leased Equipment or Equipment financed by purchase money indebtedness (in each case, and any accessions, attachments, replacements or improvements thereon) that is subject to a Lien that is permitted pursuant to subsection (ii) or (vii) of the definition of “Permitted Lien”, which is securing Indebtedness permitted pursuant to subsection (ii) or (iii) of the definition of “Permitted Indebtedness”, provided that (x) the foregoing exclusion shall apply only to the extent the applicable lease or finance contract relating to such Equipment prohibits the granting of security interests other than such Permitted Lien and (y) upon the release of any such Lien, such Equipment (and any accessions, attachments, replacements or improvements thereon) shall be deemed to be Collateral hereunder and shall be subject to the security interest granted herein without any action by Borrower or Lender, or (iv) property that is non-assignable by its terms without the consent of the licensor thereof or another party (but only to the extent such prohibition on transfer is enforceable under applicable law, including, without limitation, §9-406 and §9-408 of the UCC).  Upon payment in full in cash of the Secured Obligations (other than inchoate indemnity obligations and any other obligations which, by their terms, are to survive the termination of this Agreement), Lender’s agreements to make Advances to Borrower have been terminated, and at such time as this Agreement has been terminated, the Lender shall, at Borrower’s sole cost and expense, release its Liens in the Collateral and all rights therein shall revert to Borrower.
 
 
 

 
SECTION 4.  CONDITIONS PRECEDENT TO LOAN
 
The obligation of Lender to make the Term Loan Advances hereunder are subject to the satisfaction by Borrower of the following conditions:
 
4.1           Initial Advance.  On or prior to the Closing Date, Borrower shall have delivered to Lender the following:
 
(a)           executed originals of the Loan Documents (excluding the Pledge Agreement), Account Control Agreements, a legal opinion of Inc’s counsel, and all other documents and instruments reasonably required by Lender to effectuate the transactions contemplated hereby or to create and perfect the Liens of Lender with respect to all Collateral, in all cases in form and substance reasonably acceptable to Lender, it being acknowledged by Lender that no opinion of Russian counsel and no legal documents governed by Russian law are required to be delivered;
 
(b)           certified copy of resolutions of Inc’s board of directors evidencing approval of (i) the Loan and other transactions evidenced by the Loan Documents; and (ii) the Warrant and transactions evidenced thereby; and certified copies of the resolutions of LLC’s board of director (or equivalent) evidencing approval of the Loan and other transactions evidenced by the Loan Documents;
 
(c)           certified copies of the Certificate of Incorporation and the Bylaws (or equivalent for LLC), as amended through the Closing Date, of Borrower;
 
(d)           a certificate of good standing for Inc from its state of incorporation and similar certificates from all other jurisdictions in which it does business and where the failure to be qualified would have a Material Adverse Effect;
 
(e)           payment of the Facility Charge and reimbursement of Lender’s current expenses reimbursable pursuant to this Agreement, which amounts may be deducted from the initial Advance; and
 
(f)           such other documents as Lender may reasonably request.
 
4.2           All Advances.  On each Advance Date:
 
(a)           Lender shall have received (i) an Advance Request for the relevant Advance as required by Section 2.1(b), duly executed by Inc’s Chief Executive Officer or Chief Financial Officer, and (ii) any other documents Lender may reasonably request.
 
(b)           The representations and warranties set forth in this Agreement and in Section 5 and in the Warrant shall be true and correct in all material respects on and as of the Advance Date with the same effect as though made on and as of such date, except to the extent such representations and warranties expressly relate to an earlier date.
 
(c)           Borrower shall be in compliance with all the terms and provisions set forth herein and in each other Loan Document on its part to be observed or performed, and at the time of and immediately after such Advance no Event of Default shall have occurred and be continuing.
 
(d)           Each Advance Request shall be deemed to constitute a representation and warranty by Borrower on the relevant Advance Date as to the matters specified in paragraphs (b) and (c) of this Section 4.2 and as to the matters set forth in the Advance Request.
 
 
 

 
4.3           No Default.  As of the Closing Date and each Advance Date, (i) no fact or condition exists that would (or would, with the passage of time, the giving of notice, or both) constitute an Event of Default and (ii) no event that has had or could reasonably be expected to have a Material Adverse Effect has occurred and is continuing.
 
SECTION 5. REPRESENTATIONS AND WARRANTIES OF BORROWER
 
Borrower represents and warrants that:
 
5.1           Corporate Status.  Inc is a corporation duly organized, legally existing and in good standing under the laws of the State of Delaware, and is duly qualified as a foreign corporation in all jurisdictions in which the nature of its business or location of its properties require such qualifications and where the failure to be qualified could reasonably be expected to have a Material Adverse Effect.  LLC is a limited liability company duly organized, legally existing and in good standing under the laws of Russia, and is duly qualified as a foreign corporation in all jurisdictions in which the nature of its business or location of its properties require such qualifications and where the failure to be qualified could reasonably be expected to have a Material Adverse Effect, Borrower’s present name, former names (if any), locations, place of formation, tax identification number, organizational identification number and other information are correctly set forth in Exhibit C to the Disclosure Letter, as may be updated by Borrower in a written notice (including any Compliance Certificate) provided to Lender after the Closing Date.
 
5.2           Collateral.  Borrower owns the Collateral and owns or exclusively licenses the Intellectual Property, free of all Liens, except for Permitted Liens.  Borrower has the power and authority to grant to Lender a Lien in the Collateral as security for the Secured Obligations.
 
5.3           Consents.  Borrower’s execution, delivery and performance of the Notes (if any), this Agreement and all other Loan Documents, and Borrower’s execution of the Warrant, (i) have been duly authorized by all necessary corporate action of Borrower, (ii) will not result in the creation or imposition of any Lien upon the Collateral, other than Permitted Liens and the Liens created by this Agreement and the other Loan Documents, (iii) do not violate any provisions of Borrower’s Certificate or Articles of Incorporation (or equivalent documents of the LLC) (as applicable), bylaws, or any, law, regulation, order, injunction, judgment, decree or writ to which Borrower is subject and (iv) except as described in Schedule 5.3 to the Disclosure Letter, do not violate any contract or agreement or require the consent or approval of any other Person.  The individual or individuals executing the Loan Documents and the Warrant are duly authorized to do so.
 
5.4           Material Adverse Effect.  Since June 30, 2013, no event that has had or could reasonably be expected to have a Material Adverse Effect has occurred and is continuing.
 
5.5           Actions Before Governmental Authorities.  There are no actions, suits or proceedings at law or in equity or by or before any governmental authority now pending or, to the knowledge of Borrower, threatened against or affecting Borrower or its property.
 
5.6           Laws.  Borrower is not in violation of any law, rule or regulation, or in default with respect to any judgment, writ, injunction or decree of any governmental authority, where such violation or default is reasonably expected to result in a Material Adverse Effect.  Borrower is not in default in any manner under any provision of any agreement or instrument evidencing indebtedness, or any other material agreement to which it is a party or by which it is bound.
 
5.7           Information Correct and Current.  No information, report, Advance Request, financial statement, exhibit or schedule furnished, by or on behalf of Borrower to Lender in connection with any Loan Document or included therein or delivered pursuant thereto contained, contains or will contain any material misstatement of fact or omitted, omits or will omit to state any material fact necessary to make the statements therein, in the light of the circumstances under which they were, are or will be made, not misleading at the time such statement was made or deemed made. Additionally, any and all financial or business projections provided by Borrower to Lender shall be (i) provided in good faith and based on the most current data and information available to Borrower, and (ii) the most current of such projections approved by Inc’s Board of Directors.
 
 
 

 
5.8           Tax Matters.  Except as described in Schedule 5.8 to the Disclosure Letter, (a) Borrower has filed all federal, state and local tax returns that it is required to file, (b) Borrower has duly paid or fully reserved for all taxes or installments thereof (including any interest or penalties) as and when due, which have or may become due pursuant to such returns, and (c) Borrower has paid or fully reserved for any tax assessment received by Borrower for the three (3) years preceding the Closing Date, if any (including any taxes being contested in good faith and by appropriate proceedings).
 
5.9           Intellectual Property Claims.  Borrower is the sole owner of, or otherwise has the right to use, the Intellectual Property.  Except as described in Schedule 5.9 to the Disclosure Letter, (i) each of the material Copyrights, Trademarks and Patents is valid and enforceable, (ii) no material part of the Intellectual Property has been judged invalid or unenforceable, in whole or in part, and (iii) no claim has been made to Borrower that any material part of the Intellectual Property violates the rights of any third party. Exhibit D to the Disclosure Letter is a true, correct and complete list of each of Borrower’s Patents, registered Trademarks, registered Copyrights, and material agreements under which Borrower licenses Intellectual Property from third parties (other than shrink-wrap software licenses and open source software), together with application or registration numbers, as applicable, owned by Borrower or any Subsidiary, in each case as of the Closing Date. Borrower is not in material breach of, nor has Borrower failed to perform any material obligations under, any of the foregoing contracts, licenses or agreements and, to Borrower’s knowledge, no third party to any such contract, license or agreement is in material breach thereof or has failed to perform any material obligations thereunder.
 
5.10           Intellectual Property.  Except as described in Schedule 5.10 to the Disclosure Letter, Borrower has, or in the case of any proposed business, will have, all material rights with respect to Intellectual Property necessary in the operation or conduct of Borrower’s business as currently conducted and proposed to be conducted by Borrower.  Without limiting the generality of the foregoing, and in the case of Licenses, except for restrictions that are unenforceable under Division 9 of the UCC or as otherwise described in Schedule 5.10 to the Disclosure Letter, Borrower has the right, to the extent required to operate Borrower’s business, to freely transfer, license or assign Intellectual Property without condition, restriction or payment of any kind (other than license payments in the ordinary course of business and subject to open source software licenses) to any third party, and Borrower owns or has the right to use, pursuant to valid licenses, all software development tools, library functions, compilers and all other third-party software and other items that are used in the design, development, promotion, sale, license, manufacture, import, export, use or distribution of Borrower Products.
 
5.11           Borrower Products.  No Intellectual Property owned by Borrower or Borrower Product has been or is subject to any actual or, to the knowledge of Borrower, threatened litigation, proceeding (including any proceeding in the United States Patent and Trademark Office or any corresponding foreign office or agency) or outstanding decree, order, judgment, settlement agreement or stipulation that restricts in any manner Borrower’s use, transfer or licensing thereof or that may affect the validity, use or enforceability thereof. There is no decree, order, judgment, agreement, stipulation, arbitral award or other provision entered into in connection with any litigation or proceeding that obligates Borrower to grant licenses or ownership interest in any future Intellectual Property related to the operation or conduct of the business of Borrower or Borrower Products.  Borrower has not received any written notice or claim, or, to the knowledge of Borrower, oral notice or claim, challenging or questioning Borrower’s ownership in any Intellectual Property (or written notice of any claim challenging or questioning the ownership in any licensed Intellectual Property of the owner thereof) or suggesting that any third party has any claim of legal or beneficial ownership with respect thereto nor, to Borrower’s knowledge, is there a reasonable basis for any such claim.  To Borrower’s knowledge, neither Borrower’s use of its Intellectual Property nor the production and sale of Borrower Products infringes the Intellectual Property or other rights of others.
 
5.12           Financial Accounts.  Exhibit E to the Disclosure Letter, as may be updated by the Borrower in a written notice provided to Lender after the Closing Date, is a true, correct and complete list of (a) all banks and other financial institutions at which Borrower or any Subsidiary maintains Deposit Accounts and (b) all institutions at which Borrower or any Subsidiary maintains an account holding Investment Property, and such exhibit correctly identifies the name, address and telephone number of each bank or other institution, the name in which the account is held, a description of the purpose of the account, and the complete account number therefor.
 
 
 

 
5.13           Employee Loans.  Borrower has no outstanding loans to any employee, officer or director of the Borrower nor has Borrower guaranteed the payment of any loan made to an employee, officer or director of the Borrower by a third party.
 
5.14           Capitalization and Subsidiaries.  Borrower’s capitalization as of the Closing Date is set forth in Schedule 5.14 to the Disclosure Letter.  Borrower does not own any stock, partnership interest or other securities of any Person, except for Permitted Investments.  In Schedule 5.14 to the Disclosure Letter, as may be updated by Borrower in a written notice provided after the Closing Date, is a true, correct and complete list of each Subsidiary.
 
SECTION 6.  INSURANCE; INDEMNIFICATION
 
6.1           Coverage.  Borrower shall cause to be carried and maintained commercial general liability insurance, on an occurrence form, against risks customarily insured against in Borrower’s line of business.  Such risks shall include the risks of bodily injury, including death, property damage, personal injury, advertising injury, and contractual liability per the terms of the indemnification agreement found in Section 6.3.  Borrower collectively must maintain a minimum of $2,000,000 of commercial general liability insurance for each occurrence.  Inc has and agrees to maintain a minimum of $2,000,000 of directors’ and officers’ insurance for each occurrence and $5,000,000 in the aggregate.  So long as there are any Secured Obligations (other than inchoate indemnity obligations) outstanding, Borrower shall also cause to be carried and maintained insurance upon the Collateral, insuring against all risks of physical loss or damage howsoever caused, in an amount not less than the full replacement cost of the Collateral, provided that such insurance may be subject to standard exceptions and deductibles.  Inc shall also carry and maintain a fidelity insurance policy in an amount not less than $100,000.
 
6.2           Certificates.  Borrower shall deliver to Lender certificates of insurance that evidence Borrower’s compliance with its insurance obligations in Section 6.1 and the obligations contained in this Section 6.2.  Borrower’s insurance certificate shall state Lender is an additional insured for commercial general liability, a loss payee for all risk property damage insurance, subject to the insurer’s approval, a loss payee for fidelity insurance, and a loss payee for property insurance and additional insured for liability insurance for any future insurance that Borrower may acquire from such insurer.  Attached to the certificates of insurance will be additional insured endorsements for liability and lender’s loss payable endorsements for all risk property damage insurance and fidelity.  Any failure of Lender to scrutinize such insurance certificates for compliance is not a waiver of any of Lender’s rights, all of which are reserved.
 
6.3           Indemnity.  Borrower agrees to indemnify and hold Lender and its officers, directors, employees, agents, in-house attorneys, representatives and shareholders harmless from and against any and all claims, costs, expenses, damages and liabilities (including such claims, costs, expenses, damages and liabilities based on liability in tort, including strict liability in tort), including reasonable attorneys’ fees and disbursements and other costs of investigation or defense (including those incurred upon any appeal), that may be instituted or asserted against or incurred by Lender or any such Person as the result of credit having been extended, suspended or terminated under this Agreement and the other Loan Documents or the administration of such credit, or in connection with or arising out of the transactions contemplated hereunder and thereunder, or any actions or failures to act in connection therewith, or arising out of the disposition or utilization of the Collateral, excluding in all cases claims resulting solely from Lender’s gross negligence or willful misconduct. Borrower agrees to pay, and to save Lender harmless from, any and all liabilities with respect to, or resulting from any delay in paying, any and all excise, sales or other similar taxes (excluding taxes imposed on or measured by the net income of Lender) that may be payable or determined to be payable with respect to any of the Collateral or this Agreement.
 
SECTION 7.  COVENANTS OF BORROWER
 
Borrower agrees as follows:
 
7.1           Financial Reports.  Inc shall furnish to Lender the financial statements and reports listed hereinafter (the “Financial Statements”):
 
 
 

 
(a)           as soon as practicable (and in any event within 30 days) after the end of each month, unaudited interim monthly and year-to-date non-consolidated financial statements of Borrower’s US operations as and for the periods ended for such month, including balance sheet and related statements of income and cash flows (which shall be prepared only for the year-to-date period), all certified by Inc’s Chief Executive Officer or Chief Financial Officer to the effect that they have been prepared in accordance with GAAP, except (i) for the absence of footnotes, (ii) that they are subject to normal year-end adjustments, (iii) they do not contain certain non-cash items that are customarily included in quarterly and annual financial statements, and (iv) accruals for stock compensation expense, clinical trials, professional fees, bonus accruals, 401(k) match accruals, warrants and other similar accruals;
 
(b)           as soon as practicable (and in any event within 45 days) after the end of each calendar  quarter, unaudited interim quarterly and year-to-date consolidated financial statements as of and for the periods ended for such quarter (prepared on a consolidated basis), including balance sheet and related statements of income and cash flows (which shall be prepared only for the year-to-date period), certified by Borrower’s Chief Executive Officer or Chief Financial Officer to the effect that they have been prepared in accordance with GAAP, for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X of SEC.  Certain information and footnote disclosures normally included in the consolidated financial statements prepared in accordance with GAAP will have been condensed or omitted pursuant to such rules and regulations;
 
(c)           as soon as practicable (and in any event within one hundred fifty (150) days) after the end of each fiscal year, unqualified audited financial statements as of the end of such year (prepared on a consolidated and consolidating basis), including balance sheet and related statements of income and cash flows, and setting forth in comparative form the corresponding figures for the preceding fiscal year, certified by a firm of independent certified public accountants selected by Borrower, accompanied by any management report from such accountants;
 
(d)           as soon as practicable (and in any event within 30 days) after the end of each month, a Compliance Certificate in the form of Exhibit F to the Disclosure Letter;
 
(e)           promptly after the sending or filing thereof, as the case may be, copies of any proxy statements, financial statements or reports that Inc has made available to holders of its capital stock and copies of any regular, periodic and special reports or registration statements that Inc files with the SEC;
 
(f)           at the same time and in the same manner as it gives to its directors, copies of all notices of meetings, minutes, consents and other materials (other than materials that (i) present a potential conflict of interest with Lender; (ii) relate to executive sessions; or (iii) are covered by attorney-client privilege) that Inc provides to its directors in connection with meetings of the Board of Directors, and within 30 days after each such meeting, minutes of such meeting; and
 
(g)           financial and business projections promptly following their approval by Inc’s Board of Directors, as well as budgets, operating plans and other financial information reasonably requested by Lender.
 
Borrower shall not make any change in its (a) accounting policies or reporting practices except as required by GAAP or the applicable standard for LLC, or (b) fiscal years or fiscal quarters. The fiscal year of Borrower shall end on December 31.
 
The executed Compliance Certificate may be sent via facsimile to Lender at (650) 473-9194 or via e-mail to BJadot@HTGC.com.  All Financial Statements required to be delivered pursuant to clauses (a), (b) and (c) shall be sent via e-mail to financialstatements@herculestech.com with a copy to BJadot@HTGC.com  and BBang@HTGC.com provided, that if e-mail is not available or sending such Financial Statements via e-mail is not possible, they shall be sent via facsimile to Lender at: (866) 468-8916, attention Chief Credit Officer.
 
Notwithstanding anything herein to the contrary, documents required to be delivered pursuant to this Section 7.1 may be delivered electronically and if so delivered, shall be deemed to have been delivered on the date on which (i) such financial statements and/or appropriate disclosures are publicly available as posted on the Electronic Data Gathering Analysis and Retrieval system (EDGAR) or any successor filing system of the SEC, or (ii) Borrower posts such documents, or provides a link thereto on the Borrower’s website on the Internet.
 
 
 

 
7.2           Management Rights.  Borrower shall permit any representative that Lender authorizes, including its attorneys and accountants, to inspect the Collateral and examine and make copies and abstracts of the books of account and records of Borrower at reasonable times and upon reasonable notice during normal business hours.  In addition, any such representative shall have the right to meet with management and officers of Borrower to discuss such books of account and records.  In addition, Lender shall be entitled at reasonable times and intervals to consult with and advise the management and officers of Borrower concerning significant business issues affecting Borrower.  Such consultations shall not unreasonably interfere with Borrower’s business operations.  The parties intend that the rights granted Lender shall constitute “management rights” within the meaning of 29 C.F.R Section 2510.3-101(d)(3)(ii), but that any advice, recommendations or participation by Lender with respect to any business issues shall not be deemed to give Lender, nor be deemed an exercise by Lender of, control over Borrower’s management or policies.
 
7.3           Further Assurances.  Borrower shall from time to time execute, deliver and file, alone or with Lender, any financing statements, security agreements, collateral assignments, notices, control agreements, or other documents to perfect or give the highest priority to Lender’s Lien on the Collateral.  Borrower shall from time to time procure any instruments or documents as may be requested by Lender, and take all further action that may be necessary or desirable, or that Lender may reasonably request, to perfect and protect the Liens granted hereby and thereby.  In addition, and for such purposes only, Borrower hereby authorizes Lender to execute and deliver on behalf of Borrower and to file such financing statements, collateral assignments, notices, control agreements, security agreements and other documents without the signature of Borrower either in Lender’s name or in the name of Lender as agent and attorney-in-fact for Borrower.  Borrower shall protect and defend Borrower’s title to the Collateral and Lender’s Lien thereon against all Persons claiming any interest adverse to Borrower or Lender other than Permitted Liens.  Notwithstanding the foregoing, Borrower shall not be required to deliver documents governed by Russian law prior to an Event of Default.
 
7.4           Indebtedness.  Borrower shall not create, incur, assume, guarantee or be or remain liable with respect to any Indebtedness, or permit any Subsidiary so to do, other than Permitted Indebtedness, or prepay any Indebtedness or take any actions which impose on Borrower an obligation to prepay any Indebtedness, except for the conversion of Indebtedness into equity securities and the payment of cash in lieu of fractional shares in connection with such conversion.
 
7.5           Collateral.  Borrower shall at all times keep the Collateral, the Intellectual Property and all other property and assets used in Borrower’s business or in which Borrower now or hereafter holds any interest free and clear from any Liens whatsoever (except for Permitted Liens), and shall give Lender prompt written notice of any legal process affecting the Collateral, the Intellectual Property, such other property and assets, or any Liens thereon.  Borrower shall cause its Subsidiaries to protect and defend such Subsidiary’s title to its assets from and against all Persons claiming any interest adverse to such Subsidiary, and Borrower shall cause its Subsidiaries at all times to keep such Subsidiary’s property and assets free and clear from any Liens whatsoever (except for Permitted Liens), and shall give Lender prompt written notice of any legal process affecting such Subsidiary’s assets.  Borrower shall not agree with any Person other than Lender not to encumber its property other than: (i) any agreement evidencing an asset sale permitted hereunder, as to the assets being sold, and (ii) any agreement evidencing Indebtedness secured by clause (vii) of the definition of Permitted Liens, as to the assets securing such Indebtedness.
 
7.6           Investments.  Borrower shall not directly or indirectly acquire or own, or make any Investment in or to any Person, or permit any of its Subsidiaries so to do, other than Permitted Investments.
 
7.7           Distributions.  Borrower shall not, and shall not allow any Subsidiary to, (a) repurchase or redeem any class of stock or other equity interest other than pursuant to employee, director or consultant purchase or repurchase plans or other similar agreements, provided, however, in each case the repurchase or redemption price does not exceed the original consideration paid for such stock or equity interest, or (b) declare or pay any cash dividend or make a cash distribution on any class of stock or other equity interest, except that LLC may pay dividends to Inc and a Subsidiary may pay dividends or make distributions to its shareholders, or (c) lend money to any employees, officers or directors or guarantee the payment of any such loans granted by a third party in excess of $100,000 in the aggregate or (d) waive, release or forgive any indebtedness owed by any employees, officers or directors in excess of $100,000 in the aggregate.
 
 
 

 
7.8           Transfers.  Except for Permitted Transfers, Borrower shall not voluntarily or involuntarily transfer, sell, lease, license, lend or in any other manner convey any equitable, beneficial or legal interest in any material portion of their assets.
 
7.9           Mergers or Acquisitions.  Borrower shall not merge or consolidate, or permit any of its Subsidiaries to merge or consolidate, with or into any other business organization (other than mergers or consolidations of a Subsidiary into another Subsidiary or into Borrower), or acquire, or permit any of its Subsidiaries to acquire, all or substantially all of the capital stock or property of another Person, except where the Secured Obligations are indefeasibly paid in full, pursuant to a prepayment in accordance with Section 2.4, concurrently with the closing of any merger, consolidation or other acquisition.
 
7.10           Taxes.  Borrower and its Subsidiaries shall pay when due all taxes, fees or other charges of any nature whatsoever (together with any related interest or penalties) now or hereafter imposed or assessed against Borrower, Lender (other than taxes imposed on or measured by the net income of Lender) or the Collateral or upon Borrower’s ownership, possession, use, operation or disposition thereof or upon Borrower’s rents, receipts or earnings arising therefrom.  Borrower shall file on or before the due date therefor all personal property tax returns in respect of the Collateral.  Notwithstanding the foregoing, Borrower may contest, in good faith and by appropriate proceedings, taxes for which Borrower maintains adequate reserves therefor in accordance with GAAP.
 
7.11           Corporate Changes.  Neither Borrower nor any Subsidiary shall change its corporate name, legal form or jurisdiction of formation without twenty (20) days’ prior written notice to Lender.  Neither Borrower nor any Subsidiary shall relocate its chief executive office or its principal place of business unless: (i) it has provided prior written notice to Lender; and (ii) in the case of Inc or any domestic subsidiary that guarantees the obligations under this Agreement, such relocation shall be within the continental United States.  Neither Borrower nor any Subsidiary shall relocate any item of Collateral (other than (v) sales of Inventory in the ordinary course of business, (w) relocation of drug product or placebo product in connection with the conduct of pre-clinical or clinical studies; (x) relocations of mobile Equipment having an aggregate value of up to $100,000 in any fiscal year, (y) relocations of Equipment having an aggregate value of up to $150,000 in any fiscal year, and (z) relocations of Collateral from a location described on Exhibit C to the Disclosure Letter to another location described on Exhibit C to the Disclosure Letter) unless (i) it has provided prompt written notice to Lender, (ii) such relocation is within the continental United States or in the case of non-U.S. entities within the location of such applicable entities and, (iii) if such relocation is to a third party bailee, it has delivered a bailee agreement in form and substance reasonably acceptable to Lender.
 
7.12           Deposit Accounts.  Except for Excluded Accounts, Borrower shall not maintain any Deposit Accounts, or accounts holding Investment Property, except with respect to which Lender has an Account Control Agreement.
 
7.13           Subsidiaries.  Borrower shall notify Lender of each Subsidiary formed subsequent to the Closing Date and, within 30 days of formation, shall cause any such Subsidiary organized under the laws of any State within the United States to execute and deliver to Lender a Joinder Agreement.
 
7.14           Small Business Administration.  Lender has received a license from the U.S. Small Business Administration (“SBA”) to extend loans as a small business investment company (“SBIC”) pursuant to the Small Business Investment Act of 1958, as amended, and the associated regulations (collectively, the “SBIC Act”).  Portions of the loan to Borrower will be made under the SBA license and the SBIC Act.  Addendum 1 to this Agreement outlines various responsibilities of Lender and Borrower associated with an SBA loan, and such Addendum 1 is hereby incorporated in this Agreement.
 
SECTION 8. RIGHT TO INVEST
 
8.1           Lender or its assignee or nominee shall have the right, in its discretion, to participate in any Subsequent Financing in an amount of up to One Million Dollars ($1,000,000) (the “Investment Limit”) on the same terms, conditions and pricing afforded to others participating in any such Subsequent Financing; provided, however, Lender’s (or its assignee’s or nominee’s) participation in any such Subsequent Financing shall not exceed ten percent (10%) of such Subsequent Financing, unless otherwise approved by Borrower.  Once Lender (or its assignee or nominee) participates in a Subsequent Financing, Lender (or its assignee or nominee) shall have no further right to participate in any other Subsequent Financing.  Notwithstanding the foregoing, if Lender (or its assignee or nominee) participates in a Subsequent Financing up to the ten percent (10%) limitation set forth above, and such participation amounts to less than the Investment Limit, Lender (or its assignee or nominee) may participate in an additional Subsequent Financing up to the amount of the uninvested portion of the Investment Limit.   The terms of this Section 8.1 shall survive the termination of this Agreement.
 
 
 

 
SECTION 9. EVENTS OF DEFAULT
 
The occurrence of any one or more of the following events shall be an Event of Default:
 
9.1           Payments.  Borrower fails to pay any amount due under this Agreement or any of the other Loan Documents on the due date; or
 
9.2           Covenants.  Borrower breaches or defaults in the performance of any covenant or Secured Obligation under this Agreement, or any of the other Loan Documents, and with (a) with respect to a default under any covenant under this Agreement (other than under Sections 6, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, or 7.14(subject to the exception set forth the Addendum 1)) such default continues for more than twenty (20) days after the earlier of the date on which (i) Lender has given notice of such default to Borrower and (ii) Borrower has actual knowledge of such default, or (b) with respect to a default under any of Sections 6, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, or 7.14(subject to the exception set forth the Addendum 1)), the occurrence of such default; or
 
9.3           Material Adverse Effect.  An event has occurred that would reasonably be expected to have a Material Adverse Effect; or
 
9.4           Other Loan Documents.  The occurrence of any default under any Loan Document or any other agreement between Borrower and Lender and such default continues for more than twenty (20) days after the earlier of the date on which (a) Lender has given notice of such default to Borrower, or (b) Borrower has actual knowledge of such default; or
 
9.5           Representations.  Any representation or warranty made by Borrower in any Loan Document or in the Warrant shall have been false or misleading in any material respect; or
 
9.6           Insolvency.  Borrower (A) (i) shall make an assignment for the benefit of creditors; or (ii) shall be unable to pay its debts as they become due, or be unable to pay or perform under the Loan Documents, or shall become insolvent; or (iii) shall file a voluntary petition in bankruptcy; or (iv) shall file any petition, answer, or document seeking for itself any reorganization, arrangement, composition, readjustment, liquidation, dissolution or similar relief under any present or future statute, law or regulation pertinent to such circumstances; or (v) shall seek or consent to or acquiesce in the appointment of any trustee, receiver, or liquidator of Borrower or of all or any substantial part (i.e., 33-1/3% or more) of the assets or property of Borrower; or (vi) shall cease operations of its business as its business has normally been conducted, or terminate substantially all of its employees; or (vii) Borrower or its directors or majority shareholders shall take any action initiating any of the foregoing actions described in clauses (i) through (vi); or (B) either (i) forty-five (45) days shall have expired after the commencement of an involuntary action against Borrower seeking reorganization, arrangement, composition, readjustment, liquidation, dissolution or similar relief under any present or future statute, law or regulation, without such action being dismissed or all orders or proceedings thereunder affecting the operations or the business of Borrower being stayed; or (ii) a stay of any such order or proceedings shall thereafter be set aside and the action setting it aside shall not be timely appealed; or (iii) Borrower shall file any answer admitting or not contesting the material allegations of a petition filed against Borrower in any such proceedings; or (iv) the court in which such proceedings are pending shall enter a decree or order granting the relief sought in any such proceedings; or (v) thirty (30) days shall have expired after the appointment, without the consent or acquiescence of Borrower, of any trustee, receiver or liquidator of Borrower or of all or any substantial part of the properties of Borrower without such appointment being vacated; or
 
9.7           Attachments; Judgments.  Any portion of Borrower’s assets is attached or seized, or a levy is filed against any such assets and such attachment, seizure or levy has not been removed, discharged or rescinded within ten (10) days, or a judgment or judgments (not covered by independent third-party insurance as to which liability has been accepted by such insurance carrier) is/are entered for the payment of money, individually or in the aggregate, of at least $150,000 and such judgment remains unstayed for a period of ten (10) days, or Borrower is enjoined or in any way prevented by court order from conducting any part of its business;
 
 
 

 
9.8           Other Obligations.  The occurrence of any default under any agreement or obligation of Borrower involving any Indebtedness in excess of $150,000 which has resulted in a right by a third party or parties, whether or not exercised, to accelerate the maturity of such Indebtedness, or the occurrence of any default under any agreement  or obligation of Borrower that could reasonably be expected to have a Material Adverse Effect.
 
9.9           Post-Closing Deliverable.  Borrower fails to deliver to Lender within twenty (20) Business Days after the Closing Date, the fully-executed Pledge Agreement, together with the executed stock powers and originals stock certificates.
 
SECTION 10.  REMEDIES
 
10.1           General.  Upon and during the continuance of any one or more Events of Default, (i) Lender may, at its option, accelerate and demand payment of all or any part of the Secured Obligations together with a Prepayment Charge and declare them to be immediately due and payable (provided, that upon the occurrence of an Event of Default of the type described in Section 9.6, all of the Secured Obligations shall automatically be accelerated and made due and payable, in each case without any further notice or act), and (ii) Lender may notify any of Borrower’s account debtors to make payment directly to Lender, compromise the amount of any such account on Borrower’s behalf and endorse Lender’s name without recourse on any such payment for deposit directly to Lender’s account.  Lender may exercise all rights and remedies with respect to the Collateral under the Loan Documents or otherwise available to it under the UCC and other applicable law, including the right to release, hold, sell, lease, liquidate, collect, realize upon, or otherwise dispose of all or any part of the Collateral and the right to occupy, utilize, process and commingle the Collateral.  All Lender’s rights and remedies shall be cumulative and not exclusive.  Lender agrees that it will not issue a notice of exclusive control over any of Borrower’s Deposit Accounts or accounts containing Investment Property except upon and during the continuance of an Event of Default.
 
10.2           Collection; Foreclosure.  Upon the occurrence and during the continuance of any Event of Default, Lender may, at any time or from time to time, apply, collect, liquidate, sell in one or more sales, lease or otherwise dispose of, any or all of the Collateral, in its then condition or following any commercially reasonable preparation or processing, in such order as Lender may elect.  Any such sale may be made either at public or private sale at its place of business or elsewhere.  Borrower agrees that any such public or private sale may occur upon ten (10) calendar days’ prior written notice to Borrower.  Lender may require Borrower to assemble the Collateral and make it available to Lender at a place designated by Lender that is reasonably convenient to Lender and Borrower.  The proceeds of any sale, disposition or other realization upon all or any part of the Collateral shall be applied by Lender in the following order of priorities:
 
First, to Lender in an amount sufficient to pay in full Lender’s costs and professionals’ and advisors’ fees and expenses as described in Section 11.11;
 
Second, to Lender in an amount equal to the then unpaid amount of the Secured Obligations (including principal, interest, and the Default Rate interest), in such order and priority as Lender may choose in its sole discretion; and
 
Finally, after the full, final, and indefeasible payment in Cash of all of the Secured Obligations, to any creditor holding a junior Lien on the Collateral, or to Borrower or its representatives or as a court of competent jurisdiction may direct.
 
Lender shall be deemed to have acted reasonably in the custody, preservation and disposition of any of the Collateral if it complies with the obligations of a secured party under the UCC.
 
 
 

 
10.3           No Waiver.  Lender shall be under no obligation to marshal any of the Collateral for the benefit of Borrower or any other Person, and Borrower expressly waives all rights, if any, to require Lender to marshal any Collateral.
 
10.4           Cumulative Remedies.  The rights, powers and remedies of Lender hereunder shall be in addition to all rights, powers and remedies given by statute or rule of law and are cumulative.  The exercise of any one or more of the rights, powers and remedies provided herein shall not be construed as a waiver of or election of remedies with respect to any other rights, powers and remedies of Lender.
 
SECTION 11. MISCELLANEOUS
 
11.1           Severability.  Whenever possible, each provision of this Agreement shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement shall be prohibited by or invalid under such law, such provision shall be ineffective only to the extent and duration of such prohibition or invalidity, without invalidating the remainder of such provision or the remaining provisions of this Agreement.
 
11.2           Notice.  Except as otherwise provided herein, any notice, demand, request, consent, approval, declaration, service of process or other communication (including the delivery of Financial Statements) that is required, contemplated, or permitted under the Loan Documents or with respect to the subject matter hereof shall be in writing, and shall be deemed to have been validly served, given, delivered, and received upon the earlier of: (i) the day of transmission by facsimile or hand delivery or delivery by an overnight express service or overnight mail delivery service; or (ii) the third calendar day after deposit in the United States mails, with proper first class postage prepaid, in each case addressed to the party to be notified as follows:
 
 
If to Lender:
HERCULES TECHNOLOGY II, L.P.
 
Legal Department
 
Attention:  Chief Legal Officer and Mr. Bryan Jadot
 
400 Hamilton Avenue, Suite 310
 
Palo Alto, California 94301
 
Facsimile:  650-473-9194
 
Telephone:  650-289-3060

 
If to Borrower:
CLEVELAND BIOLABS, INC.
 
Attention:  Leah Brownlee
 
73 High Street
 
Buffalo, New York 14203
 
Facsimile:  (716) 849-6820
 
Telephone:  716-849-6810 x379

 
BIOLAB 612, LLC
 
Attention: Leah Brownlee
 
73 High Street
 
Buffalo, New York  14203
 
Facsimile: (716) 849-6820
 
Telephone:  (716) 849-6810 x379

or to such other address as each party may designate for itself by like notice.
 
11.3           Borrower Liability.  Either Borrower may, acting singly, request Advances hereunder.  Each Borrower hereby appoints the other as agent for the other for all purposes hereunder, including with respect to requesting Advances hereunder.  Each Borrower hereunder shall be jointly and severally obligated to repay all Advances made hereunder, regardless of which Borrower actually receives said Advance, as if each Borrower hereunder directly received all Advances.  Each Borrower waives (a) any suretyship defenses available to it under the Code or any other applicable law, including, without limitation, the benefit of California Civil Code Section 2815 permitting revocation as to future transactions and the benefit of California Civil Code Sections 1432, 2809, 2810, 2819, 2839, 2845, 2847, 2848, 2849, 2850, and 2899 and 3433, and (b) any right to require Lender to: (i) proceed against any Borrower or any other person; (ii) proceed against or exhaust any security; or (iii) pursue any other remedy.  Lender may exercise or not exercise any right or remedy it has against any Borrower or any security it holds (including the right to foreclose by judicial or non-judicial sale) without affecting any Borrower’s liability.  Notwithstanding any other provision of this Agreement or other related document, each Borrower irrevocably waives all rights that it may have at law or in equity (including, without limitation, any law subrogating Borrower to the rights of Lender under this Agreement) to seek contribution, indemnification or any other form of reimbursement from any other Borrower, or any other Person now or hereafter primarily or secondarily liable for any of the Secured Obligations, for any payment made by Borrower with respect to the Secured Obligations in connection with this Agreement or otherwise and all rights that it might have to benefit from, or to participate in, any security for the Secured Obligations as a result of any payment made by Borrower with respect to the Secured Obligations in connection with this Agreement or otherwise.  Any agreement providing for indemnification, reimbursement or any other arrangement prohibited under this Section shall be null and void.  If any payment is made to a Borrower in contravention of this Section, such Borrower shall hold such payment in trust for Lender and such payment shall be promptly delivered to Lender for application to the Secured Obligations, whether matured or unmatured.
 
 
 

 
11.4           Entire Agreement; Amendments.  This Agreement and the other Loan Documents constitute the entire agreement and understanding of the parties hereto in respect of the subject matter hereof and thereof, and supersede and replace in their entirety any prior proposals, term sheets, non-disclosure or confidentiality agreements, letters, negotiations or other documents or agreements, whether written or oral, with respect to the subject matter hereof or thereof (including Lender’s revised proposal letter dated August 20, 2013).  None of the terms of this Agreement or any of the other Loan Documents may be amended except by an instrument executed by each of the parties hereto.
 
11.5           No Strict Construction.  The parties hereto have participated jointly in the negotiation and drafting of this Agreement.  In the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the parties hereto and no presumption or burden of proof shall arise favoring or disfavoring any party by virtue of the authorship of any provisions of this Agreement.
 
11.6           No Waiver.  The powers conferred upon Lender by this Agreement are solely to protect its rights hereunder and under the other Loan Documents and its interest in the Collateral and shall not impose any duty upon Lender to exercise any such powers.  No omission or delay by Lender at any time to enforce any right or remedy reserved to it, or to require performance of any of the terms, covenants or provisions hereof by Borrower at any time designated, shall be a waiver of any such right or remedy to which Lender is entitled, nor shall it in any way affect the right of Lender to enforce such provisions thereafter.
 
11.7           Survival.  All agreements, representations and warranties contained in this Agreement and the other Loan Documents or in any document delivered pursuant hereto or thereto shall be for the benefit of Lender and shall survive the execution and delivery of this Agreement and the expiration or other termination of this Agreement (other than the Warrant which shall survive only in accordance with its own terms).
 
11.8           Successors and Assigns.  The provisions of this Agreement and the other Loan Documents shall inure to the benefit of and be binding on Borrower and its permitted assigns (if any).  Borrower shall not assign its obligations under this Agreement or any of the other Loan Documents without Lender’s express prior written consent, and any such attempted assignment shall be void and of no effect.  Lender may assign, transfer, or endorse its rights hereunder and under the other Loan Documents (unless otherwise expressly prohibited in such documents) without prior notice to Borrower, and all of such rights shall inure to the benefit of Lender’s successors and assigns.
 
11.9           Governing Law.  This Agreement and the other Loan Documents have been negotiated and delivered to Lender in the State of California, and shall have been accepted by Lender in the State of California.  Payment to Lender by Borrower of the Secured Obligations is due in the State of California.  This Agreement and the other Loan Documents (with the exception of Account Control Agreements, which shall be governed by the jurisdiction as provided for therein, as applicable) shall be governed by, and construed and enforced in accordance with, the laws of the State of California, excluding conflict of laws principles that would cause the application of laws of any other jurisdiction.
 
 
 

 
11.10           Consent to Jurisdiction and Venue.  All judicial proceedings (to the extent that the reference requirement of Section 11.10 is not applicable) arising in or under or related to this Agreement or any of the other Loan Documents may be brought in any state or federal court located in the State of California.  By execution and delivery of this Agreement, each party hereto generally and unconditionally: (a) consents to nonexclusive personal jurisdiction in Santa Clara County, State of California; (b) waives any objection as to jurisdiction or venue in Santa Clara County, State of California; (c) agrees not to assert any defense based on lack of jurisdiction or venue in the aforesaid courts; and (d) irrevocably agrees to be bound by any judgment rendered thereby in connection with this Agreement or the other Loan Documents.  Service of process on any party hereto in any action arising out of or relating to this Agreement shall be effective if given in accordance with the requirements for notice set forth in Section 11.2, and shall be deemed effective and received as set forth in Section 11.2.  Nothing herein shall affect the right to serve process in any other manner permitted by law or shall limit the right of either party to bring proceedings in the courts of any other jurisdiction.
 
11.11           Mutual Waiver of Jury Trial / Judicial Reference.
 
(a)           Because disputes arising in connection with complex financial transactions are most quickly and economically resolved by an experienced and expert person and the parties wish applicable state and federal laws to apply (rather than arbitration rules), the parties desire that their disputes be resolved by a judge applying such applicable laws.  EACH OF BORROWER AND LENDER SPECIFICALLY WAIVES ANY RIGHT IT MAY HAVE TO TRIAL BY JURY OF ANY CAUSE OF ACTION, CLAIM, CROSS-CLAIM, COUNTERCLAIM, THIRD PARTY CLAIM OR ANY OTHER CLAIM (COLLECTIVELY, “CLAIMS”) ASSERTED BY BORROWER AGAINST LENDER OR ITS ASSIGNEE OR BY LENDER OR ITS ASSIGNEE AGAINST BORROWER.  This waiver extends to all such Claims, including Claims that involve Persons other than Borrower and Lender; Claims that arise out of or are in any way connected to the relationship between Borrower and Lender; and any Claims for damages, breach of contract, tort, specific performance, or any equitable or legal relief of any kind, arising out of this Agreement, any other Loan Document.
 
(b)           If the waiver of jury trial set forth in Section 11.10(a) is ineffective or unenforceable, the parties agree that all Claims shall be resolved by reference to a private judge sitting without a jury, pursuant to Code of Civil Procedure Section 638, before a mutually acceptable referee or, if the parties cannot agree, a referee selected by the Presiding Judge of the Santa Clara County, California.  Such proceeding shall be conducted in Santa Clara County, California, with California rules of evidence and discovery applicable to such proceeding.
 
(c)           In the event Claims are to be resolved by judicial reference, either party may seek from a court identified in Section 11.9, any prejudgment order, writ or other relief and have such prejudgment order, writ or other relief enforced to the fullest extent permitted by law notwithstanding that all Claims are otherwise subject to resolution by judicial reference.
 
11.12           Professional Fees.  Borrower promises to pay Lender’s fees and expenses necessary to finalize the loan documentation, including but not limited to reasonable attorneys’ fees, UCC searches, filing costs, and other miscellaneous expenses. In addition, Borrower promises to pay any and all reasonable attorneys’ and other professionals’ fees and expenses (including fees and expenses of in-house counsel) incurred by Lender after the Closing Date in connection with or related to:  (a) the Loan; (b) the administration, collection, or enforcement of the Loan; (c) the amendment or modification of the Loan Documents; (d) any waiver, consent, release, or termination under the Loan Documents; (e) the protection, preservation, sale, lease, liquidation, or disposition of Collateral or the exercise of remedies with respect to the Collateral; (f) any legal, litigation, administrative, arbitration, or out of court proceeding in connection with or related to Borrower or the Collateral, and any appeal or review thereof; and (g) any bankruptcy, restructuring, reorganization, assignment for the benefit of creditors, workout, foreclosure, or other action related to Borrower, the Collateral, the Loan Documents, including representing Lender in any adversary proceeding or contested matter commenced or continued by or on behalf of Borrower’s estate, and any appeal or review thereof.
 
11.13           Confidentiality.  Lender acknowledges that certain items of Collateral and information provided to Lender by Borrower are confidential and proprietary information of Borrower, if and to the extent such information either (x) is marked as confidential by Borrower at the time of disclosure, or (y) should reasonably be understood to be confidential (the “Confidential Information”).  Accordingly, Lender agrees that any Confidential Information it may obtain in the course of acquiring, administering, or perfecting  Lender’s security interest in the Collateral shall not be disclosed to any other person or entity in any manner whatsoever, in whole or in part, without the prior written consent of Borrower, except that Lender may disclose any such information:  (a) to its own directors, officers, employees, accountants, counsel and other professional advisors and to its affiliates if Lender in its sole discretion determines that any such party should have access to such information in connection with such party’s responsibilities in connection with the Loan or this Agreement and, provided that such recipient of such Confidential Information either (i) agrees to be bound by the confidentiality provisions of this paragraph or (ii) is otherwise subject to confidentiality restrictions that reasonably protect against the disclosure of Confidential Information; (b) if such information is generally available to the public through no fault of Lender; (c) if required or appropriate in any report, statement or testimony submitted to any governmental authority having or claiming to have jurisdiction over Lender; (d) if required or appropriate in response to any summons or subpoena or in connection with any litigation, to the extent permitted or deemed advisable by Lender’s counsel; (e) to comply with any legal requirement or law applicable to Lender; (f) to the extent reasonably necessary in connection with the exercise of any right or remedy under any Loan Document, including Lender’s sale, lease, or other disposition of Collateral after default; (g) to any participant or assignee of Lender or any prospective participant or assignee; provided, that such participant or assignee or prospective participant or assignee agrees in writing to be bound by this Section prior to disclosure; or (h) otherwise with the prior consent of Borrower; provided, that any disclosure made in violation of this Agreement shall not affect the obligations of Borrower or any of its affiliates or any guarantor under this Agreement or the other Loan Documents.
 
 
 

 
11.14           Assignment of Rights.  Borrower acknowledges and understands that Lender may sell and assign all or part of its interest hereunder and under the Loan Documents to any person or entity (an “Assignee”).  After such assignment the term “Lender” as used in the Loan Documents shall mean and include such Assignee, and such Assignee shall be vested with all rights, powers and remedies of Lender hereunder with respect to the interest so assigned; but with respect to any such interest not so transferred, Lender shall retain all rights, powers and remedies hereby given.  No such assignment by Lender shall relieve Borrower of any of its obligations hereunder.  Lender agrees that in the event of any transfer by it of the Note(s)(if any), it will endorse thereon a notation as to the portion of the principal of the Note(s), which shall have been paid at the time of such transfer and as to the date to which interest shall have been last paid thereon.
 
11.15           Revival of Secured Obligations.  This Agreement and the Loan Documents shall remain in full force and effect and continue to be effective if any petition is filed by or against Borrower for liquidation or reorganization, if Borrower becomes insolvent or makes an assignment for the benefit of creditors, if a receiver or trustee is appointed for all or any significant part of Borrower’s assets, or if any payment or transfer of Collateral is recovered from Lender.  The Loan Documents and the Secured Obligations and Collateral security shall continue to be effective, or shall be revived or reinstated, as the case may be, if at any time payment and performance of the Secured Obligations or any transfer of Collateral to Lender, or any part thereof is rescinded, avoided or avoidable, reduced in amount, or must otherwise be restored or returned by, or is recovered from, Lender or by any obligee of the Secured Obligations, whether as a “voidable preference,” “fraudulent conveyance,” or otherwise, all as though such payment, performance, or transfer of Collateral had not been made.  In the event that any payment, or any part thereof, is rescinded, reduced, avoided, avoidable, restored, returned, or recovered, the Loan Documents and the Secured Obligations shall be deemed, without any further action or documentation, to have been revived and reinstated except to the extent of the full, final, and indefeasible payment to Lender in Cash (other than inchoate indemnity obligations).
 
11.16           Counterparts.  This Agreement and any amendments, waivers, consents or supplements hereto may be executed in any number of counterparts, and by different parties hereto in separate counterparts, each of which when so delivered shall be deemed an original, but all of which counterparts shall constitute but one and the same instrument.
 
11.17           No Third Party Beneficiaries.  No provisions of the Loan Documents are intended, nor will be interpreted, to provide or create any third-party beneficiary rights or any other rights of any kind in any person other than Lender and Borrower unless specifically provided otherwise herein, and, except as otherwise so provided, all provisions of the Loan Documents will be personal and solely between the Lender and the Borrower.
 
 
 

 
11.18           Publicity.  Lender may use Borrower’s name and logo, and include a brief description of the relationship between Borrower and Lender, in Lender’s marketing materials.  (a)  Borrower consents to the publication and use by Lender and any of its member businesses and affiliates of (i) Borrower's name (including a brief description of the relationship between Borrower and Lender) and logo and a hyperlink to Borrower’s web site, separately or together, in written and oral presentations, advertising, promotional and marketing materials, client lists, public relations materials or on its web site (together, the “Lender Publicity Materials”); (ii) the names of officers of Borrower in the Lender Publicity Materials; and (iii) Borrower’s name, trademarks or servicemarks in any news release concerning Lender.
 
(b)           Neither Borrower nor any of its member businesses and affiliates shall, without Lender’s consent, publicize or use (i) Lender's name (including a brief description of the relationship between Borrower and Lender), logo or hyperlink to Lender’s web site, separately or together, in written and oral presentations, advertising, promotional and marketing materials, client lists, public relations materials or on its web site (together, the “Borrower Publicity Materials”); (ii) the names of officers of Lender in the Borrower Publicity Materials; and (iii) Lender’s name, trademarks, servicemarks in any news release concerning Borrower.
 
(SIGNATURES TO FOLLOW)
 
 
 

 
IN WITNESS WHEREOF, Borrower and Lender have duly executed and delivered this Loan and Security Agreement as of the day and year first above written.
 
BORROWER:
CLEVELAND BIOLABS, INC.

Signature:   /s/ C. Neil Lyons
Print Name: C. Neil Lyons
Title:            Chief Financial Officer

BIOLAB 612, LLC

Signature:    /s/ Askar Kuchumov
Print Name:  Askar Kuchumov, Ph.D.
Title:             General Director

Accepted in Palo Alto, California:                                                     LENDER:
HERCULES TECHNOLOGY II, L.P.,
a Delaware limited partnership

By:          Hercules Technology SBIC
Management, LLC,
its General Partner

By:           Hercules Technology Growth Capital, Inc.,its Manager

By:       /s/ K. Nicholas Martitsch
Name:  K. Nicholas Martitsch
Its:       Associate General Counsel
 
 
 
 
 

 
Table of Addenda, Exhibits and Schedules

Addendum 1:   SBA Provisions
Exhibit B-1:       Term Note
Exhibit G:          Joinder Agreement
 
 
 
 
 
 

 
ADDENDUM 1 TO LOAN AND SECURITY AGREEMENT
 

 
(a)           Borrower’s Business.  For purposes of this Addendum 1, Borrower shall be deemed to include its “affiliates” as defined in Title 13 Code of Federal Regulations Section 121.103.  Borrower represents and warrants to Lender as of the Closing Date and covenants to Lender for a period of one year after the Closing Date with respect to subsections 2, 3, 4, 5, 6 and 7 below, as follows:
 
1.           Size Status.  Borrower does not have tangible net worth in excess of $18 million or average net income after Federal income taxes (excluding any carry-over losses) for the preceding two completed fiscal years in excess of Six Million Dollars ($6,000,000);
 
2.           No Relender.  Borrower’s primary business activity does not involve, directly or indirectly, providing funds to others, purchasing debt obligations, factoring, or long-term leasing of equipment with no provision for maintenance or repair;
 
3.           No Passive Business.  Borrower is engaged in a regular and continuous business operation (excluding the mere receipt of payments such as dividends, rents, lease payments, or royalties).  Borrower’s employees are carrying on the majority of day to day operations.  Borrower will not pass through substantially all of the proceeds of the Loan to another entity;
 
4.           No Real Estate Business.  Borrower is not classified under Major Group 65 (Real Estate) or Industry No. 1531 (Operative Builders) of the Standard Industrial Classification Manual.  The proceeds of the Loan will not be used to acquire or refinance real property unless Borrower (x) is acquiring an existing property and will use at least fifty-one percent (51%) of the usable square footage for its business purposes; (y) is building or renovating a building and will use at least sixty-seven percent (67%) of the usable square footage for its business purposes; or (z) occupies the subject property and uses at least sixty-seven percent (67%) of the usable square footage for its business purposes.
 
5.           No Project Finance.  Borrower’s assets are not intended to be reduced or consumed, generally without replacement, as the life of its business progresses, and the nature of Borrower’s business does not require that a stream of cash payments be made to the business's financing sources, on a basis associated with the continuing sale of assets (e.g., real estate development projects and oil and gas wells).  The primary purpose of the Loan is not to fund production of a single item or defined limited number of items, generally over a defined production period, where such production will constitute the majority of the activities of Borrower (e.g., motion pictures and electric generating plants).
 
6.           No Farm Land Purchases.  Borrower will not use the proceeds of the Loan to acquire farm land which is or is intended to be used for agricultural or forestry purposes, such as the production of food, fiber, or wood, or is so taxed or zoned.
 
7.           No Foreign Investment.  The proceeds of the Loan will not be used substantially for a foreign operation.  At the time of the Loan, Borrower will not have more than forty-nine percent (49%) of its employees or tangible assets located outside the United States.  The representation in this subsection (7) is made only as of the date hereof and shall not continue for one year as contemplated in the first sentence of this Section 1.
 
(b)           Small Business Administration Documentation.  Lender acknowledges that Borrower completed, executed and delivered to Lender SBA Forms 480, 652 and 1031 (Parts A and B) together with a business plan showing Borrower’s financial projections (including balance sheets and income and cash flows statements) for the period described therein and a written statement (whether included in the purchase agreement or pursuant to a separate statement) from Lender regarding its intended use of proceeds from the sale of securities to Lender (the “Use of Proceeds Statement”).  Borrower represents and warrants to Lender that the information regarding Borrower and its affiliates set forth in the SBA Form 480, Form 652 and Form 1031 and the Use of Proceeds Statement delivered as of the Closing Date is accurate and complete.
 
 
 

 
(c)           Inspection.  The following covenants contained in this Section (c) are intended to supplement and not to restrict the related provisions of the Loan Documents.  Subject to the preceding sentence, Borrower will permit, for so long as Lender holds any debt or equity securities of Borrower, Lender or its representative, at Lender’ expense, and examiners of the SBA to visit and inspect the properties and assets of Borrower, to examine its books of account and records, and to discuss Borrower’s affairs, finances and accounts with Borrower’s officers, senior management and accountants, all at such reasonable times as may be requested by Lender or the SBA.
 
(d)           Annual Assessment.  Promptly after the end of each calendar year (but in any event prior to February 28 of each year) and at such other times as may be reasonably requested by Lender, Borrower will deliver to Lender a written assessment of the economic impact of Lender’ investment in Borrower, specifying the full-time equivalent jobs created or retained in connection with the investment, the impact of the investment on the businesses of Borrower in terms of expanded revenue and taxes, other economic benefits resulting from the investment (such as technology development or commercialization, minority business development, or expansion of exports) and such other information as may be required regarding Borrower in connection with the filing of Lender’s SBA Form 468.   Lender will assist Borrower with preparing such assessment.  In addition to any other rights granted hereunder, Borrower will grant Lender and the SBA access to Borrower’s books and records for the purpose of verifying the use of such proceeds.  Borrower also will furnish or cause to be furnished to Lender such other information regarding the business, affairs and condition of Borrower as Lender may from time to time reasonably request.
 
(e)           Use of Proceeds.  Borrower will use the proceeds from the Loan only for purposes set forth in Section 7.14.  Borrower will deliver to Lender from time to time promptly following Lender’s request, a written report, certified as correct by Borrower's Chief Financial Officer, verifying the purposes and amounts for which proceeds from the Loan have been disbursed.  Borrower will supply to Lender such additional information and documents as Lender reasonably requests with respect to its use of proceeds and will permit Lender and the SBA to have access to any and all Borrower records and information and personnel as Lender deems necessary to verify how such proceeds have been or are being used, and to assure that the proceeds have been used for the purposes specified in Section 7.14.
 
(f)           Activities and Proceeds.  Neither Borrower nor any of its affiliates (if any) will engage in any activities or use directly or indirectly the proceeds from the Loan for any purpose for which a small business investment company is prohibited from providing funds by the SBIC Act, including 13 C.F.R. §107.720.  Without obtaining the prior written approval of Lender, Borrower will not change within 1 year of the date hereof, Borrower’s current business activity to a business activity which a licensee under the SBIC Act is prohibited from providing funds by the SBIC Act.
 
(g)           Redemption Provisions.  Notwithstanding any provision to the contrary contained in the Certificate of Incorporation of Borrower, as amended from time to time (the “Charter”), if, pursuant to the redemption provisions contained in the Charter, Lender is entitled to a redemption of its Warrant, such redemption (in the case of Lender) will be at a price equal to the redemption price set forth in the Charter (the “Existing Redemption Price”).  If, however, Lender delivers written notice to Borrower that the then current regulations promulgated under the SBIC Act prohibit payment of the Existing Redemption Price in the case of an SBIC (or, if applied, the Existing Redemption Price would cause the Common Stock to lose its classification as an “equity security” and Lender has determined that such classification is unadvisable), the amount Lender will be entitled to receive shall be the greater of (i) fair market value of the securities being redeemed taking into account the rights and preferences of such securities plus any costs and expenses of the Lender incurred in making or maintaining the Warrant, and (ii) the Existing Redemption Price where the amount of accrued but unpaid dividends payable to the Lender is limited to Borrower's earnings plus any costs and expenses of the Lender incurred in making or maintaining the Warrant; provided, however, the amount calculated in subsections (i) or (ii) above shall not exceed the Existing Redemption Price.
 
 
 

 
(h)             Compliance and Resolution.   Borrower agrees that a failure to comply with Borrower’s obligations under this addendum, or any other set of facts or circumstances where it has been asserted by any governmental regulatory agency (or Lender believes that there is a substantial risk of such assertion) that Lender and its affiliates are not entitled to hold, or exercise any significant right with respect to, any securities issued to Lender by Borrower, will constitute a breach of the obligations of Borrower under the financing agreements between Borrower and Lender.  In the event of (i) a failure to comply with Borrower’s obligations under this Addendum; or (ii) an assertion by any governmental regulatory agency (or Lender believes that there is a substantial risk of such assertion) of a failure to comply with Borrower’s obligations under this Addendum, then (i) Lender and Borrower will meet and resolve any such issue in good faith to the satisfaction of Borrower, Lender, and any governmental regulatory agency, and (ii) upon request of Lender or Borrower, Borrower and/or Lender, as applicable, will cooperate and assist with any assignment of the financing agreements from Hercules Technology II, L.P. to Hercules Technology Growth Capital, Inc. so that the Term Loan and Loan Documents will no longer be subject to the SBIC Act or other SBA provision, and any such assignment (i) shall be at no cost to Borrower and (ii) shall not constitute an Event of Default under the Loan Documents.  And any breach or failure to comply pursuant to the preceding portion of this paragraph or Section 7.14 of the Loan Agreement shall not constitute an Event of Default.
 
 
 
 

 
EXHIBIT B-1
 
PROMISSORY NOTE
 
$[  ],000,000                                                                                                Advance Date:  ___ __, 2013
 
Maturity Date:  _____ ___, 20[ ]
 
FOR VALUE RECEIVED, Cleveland BioLabs, Inc. (“Inc”) and BioLab 612, LLC (“LLC”), (Inc and LLC, individually and collectively referred to herein as “Borrower”) hereby promises to pay to the order of Hercules Technology II, L.P., a Delaware limited partnership or the holder of this Note (the “Lender”) at 400 Hamilton Avenue, Suite 310, Palo Alto, CA 94301 or such other place of payment as the holder of this Secured Term Promissory Note (this “Promissory Note”) may specify from time to time in writing, in lawful money of the United States of America, the principal amount of [  ] Million Dollars ($[  ],000,000) or such other principal amount as Lender has advanced to Borrower, together with interest at a floating rate per annum rate equal to the greater of either (i) ten and forty-five hundredths of one percent (10.45%), or (ii) the sum of (A) ten and forty-five hundredths of one percent (10.45%), plus (B) the Prime Rate minus four and one quarter of one percent (4.25%) based upon a year consisting of 360 days, with interest computed daily based on the actual number of days in each month.
 
This Promissory Note is the Note referred to in, and is executed and delivered in connection with, that certain Loan and Security Agreement dated [              ], 20[  ], by and between Borrower and Lender (as the same may from time to time be amended, modified or supplemented in accordance with its terms, the “Loan Agreement”), and is entitled to the benefit and security of the Loan Agreement and the other Loan Documents (as defined in the Loan Agreement), to which reference is made for a statement of all of the terms and conditions thereof.  All payments shall be made in accordance with the Loan Agreement.  All terms defined in the Loan Agreement shall have the same definitions when used herein, unless otherwise defined herein.  An Event of Default under the Loan Agreement shall constitute a default under this Promissory Note.
 
Borrower waives presentment and demand for payment, notice of dishonor, protest and notice of protest under the UCC or any applicable law.   Borrower agrees to make all payments under this Promissory Note without setoff, recoupment or deduction and regardless of any counterclaim or defense.  This Promissory Note has been negotiated and delivered to Lender and is payable in the State of California.  This Promissory Note shall be governed by and construed and enforced in accordance with, the laws of the State of California, excluding any conflicts of law rules or principles that would cause the application of the laws of any other jurisdiction.
 

 
BORROWER:                                                                                     CLEVELAND BIOLABS, INC.
 
By:
Title:
 

 
BIOLAB 612, LLC
 
By:
Title:
 
 
 

 
EXHIBIT G
 
FORM OF JOINDER AGREEMENT
 
This Joinder Agreement (the “Joinder Agreement”) is made and dated as of [          ], 201[ ], and is entered into by and between__________________, a ___________ corporation (“Subsidiary”), and HERCULES TECHNOLOGY II, L.P. as a Lender.
 
RECITALS
 
A.           Subsidiary’s Affiliate, Cleveland BioLabs, Inc. (“Inc”) and BioLab 612, LLC (“LLC”) (Inc and LLC, individually and collectively referred to herein as “Borrower”) [has entered/desires to enter] into that certain Loan and Security Agreement dated [         ], 2013, with Lender, as such agreement may be amended (the “Loan Agreement”), together with the other agreements executed  and delivered in connection therewith;
 
B.           Subsidiary acknowledges and agrees that it will benefit both directly and indirectly from Borrower’s execution of the Loan Agreement and the other agreements executed and delivered in connection therewith;
 
AGREEMENT
 
NOW THEREFORE, Subsidiary and Lender agree as follows:
 
1.           The recitals set forth above are incorporated into and made part of this Joinder Agreement.  Capitalized terms not defined herein shall have the meaning provided in the Loan Agreement.
 
2.           By signing this Joinder Agreement, Subsidiary shall be bound by the terms and conditions of the Loan Agreement the same as if it were the Borrower (as defined in the Loan Agreement) under the Loan Agreement, mutatis mutandis, provided however, that Lender shall have no duties, responsibilities or obligations to Subsidiary arising under or related to the Loan Agreement or the other agreements executed and delivered in connection therewith.  Rather, to the extent that Lender has any duties, responsibilities or obligations arising under or related to the Loan Agreement or the other agreements executed and delivered in connection therewith, those duties, responsibilities or obligations shall flow only to Borrower and not to Subsidiary or any other person or entity.  By way of example (and not an exclusive list): (a) Lender’s providing notice to Borrower in accordance with the Loan Agreement or as otherwise agreed between Borrower and Lender shall be deemed provided to Subsidiary; (b) a Lender’s providing an Advance to Borrower shall be deemed an Advance to Subsidiary; and (c) Subsidiary shall have no right to request an Advance or make any other demand on Lender.
 
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
 
 
 

 
[SIGNATURE PAGE TO JOINDER AGREEMENT]
 
SUBSIDIARY:
_________________________________.

 
 
By:
Name:
Title:
Address:
 
Telephone: ___________
Facsimile: ____________
 
LENDER:                HERCULES TECHNOLOGY II, L.P.,
a Delaware limited partnership
 
By:          Hercules Technology SBIC Management, LLC,
its General Partner
 
By:          Hercules Technology Growth Capital, Inc.,
its Manager
 
By:__________________________________
Name: _______________________________
Its:      _______________________________
 
EX-31.1 4 exh_311.htm EXHIBIT 31.1 exh_311.htm
Exhibit 31.1
 
Certification
 
I, Yakov Kogan, certify that:
 
1.
I have reviewed this quarterly report on Form 10-Q of Cleveland BioLabs, 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 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 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.
 
5.
The registrant’s other certifying officer 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.
 
 
Dated: November 8, 2013 By: /s/ YAKOV KOGAN ____
Yakov Kogan
Chief Executive Officer
(Principal Executive Officer)
 
 
                                                                          
 
 
EX-31.2 5 exh_312.htm EXHIBIT 31.2 exh_312.htm
Exhibit 31.2
 
Certification
 
I, C. Neil Lyons, certify that:
 
1.
I have reviewed this quarterly report on Form 10-Q of Cleveland BioLabs, 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 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 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.
 
5.
The registrant’s other certifying officer 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.
 
 
Dated: November 8, 2013  By: /s/ C. NEIL LYONS ____
C. Neil Lyons
Chief Financial Officer
(Principal Financial Officer)
 
 
                                                                               
EX-32.1 6 exh_321.htm EXHIBIT 32.1 exh_321.htm
Exhibit 32.1
 
Certification*
 
In connection with the Quarterly Report of Cleveland BioLabs, Inc. (the “Company”) on Form 10-Q for the quarter ending September 30, 2013, as filed with the Securities and Exchange Commission on the date hereof (the “Quarterly Report”), pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Yakov Kogan, Chief Executive Officer of the Company, and C. Neil Lyons, Chief Financial Officer of the Company, each hereby certifies that, to the best of his or her knowledge:

1.  
The Quarterly Report fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act, and
 
2.  
The information contained in the Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of the Company for the period covered by the Quarterly Report.
 
 
Dated: November 8, 2013  By: /s/ YAKOV KOGAN __________
Yakov Kogan
Chief Executive Officer
(Principal Executive Officer)
   
   
Dated: November 8, 2013  By: /s/ C. NEIL LYONS ___________
C. Neil Lyons
Chief Financial Officer
(Principal Financial Officer)
 
*
This certification accompanies the Quarterly Report to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Cleveland BioLabs, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Quarterly Report), irrespective of any general incorporation language contained in such filing.
 
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Description of Business</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Cleveland BioLabs, Inc. (&#8220;CBLI&#8221;) is a clinical-stage biotechnology company with a focus on oncology and acute radiation syndrome drug development. Since inception, CBLI has pursued the research, development and commercialization of products that have the potential to treat cancer, reduce death from total body irradiation and counteract the toxic effects of radio- and chemotherapies for oncology patients.</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">CBLI is incorporated under the laws of the State of Delaware and is headquartered in Buffalo, New York. CBLI has one wholly-owned operating subsidiary, BioLab 612, LLC (&#8220;BioLab 612&#8221;), which began operations in 2012. CBLI also has two majority-owned operating subsidiaries, Incuron, LLC (&#8220;Incuron&#8221;) and Panacela Labs, Inc. (&#8220;Panacela&#8221;), which were formed in 2010 and 2011, respectively. Additionally, Panacela has a wholly-owned operating subsidiary, Panacela Labs, LLC.</font> </div><br/> 1 2 <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">2. Summary of Significant Accounting Policies</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Basis of Presentation and Consolidation</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">The accompanying consolidated financial statements include the accounts of CBLI and its subsidiaries, BioLab 612, Incuron and Panacela, collectively referred to herein as the &#8220;Company.&#8221; All significant intercompany balances and transactions have been eliminated in consolidation.</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">The unaudited consolidated financial statements included herein have been prepared in accordance with U.S.&#160;generally accepted accounting principles for interim financial information and in accordance with the instructions to Form&#160;10-Q and Article&#160;10 of Regulation&#160;S-X of the Securities and Exchange Commission ("SEC"). Certain information and footnote disclosures normally included in consolidated financial statements prepared in accordance with U.S.&#160;generally accepted accounting principles have been condensed or omitted pursuant to such rules and regulations. These consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto contained in the Company&#8217;s Annual Report on Form&#160;10-K for the year ended December&#160;31, 2012, as amended, as filed with the SEC..</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">In the opinion of the Company&#8217;s management, any adjustments contained in the accompanying unaudited consolidated financial statements are of a normal recurring nature, and are necessary to present fairly the financial position of the Company as of September 30, 2013, along with its results of operations for the three and nine month periods ended September 30, 2013 and 2012 and cash flows for the nine month periods ended September 30, 2013 and 2012.&#160;&#160;Interim results are not necessarily indicative of results that may be expected for any other interim period or for an entire year.</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Recent Accounting Pronouncements</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">In July 2013, the FASB issued ASU No.&#160;2013-11, &#8220;Income Taxes (Topic 740): Presentation of an Unrecognized Tax Benefit When a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists (a consensus of the FASB Emerging Issues Task Force)&#8221; (&#8220;ASU 2013-11&#8221;). The amendments of ASU 2013-11 provide entities with guidance of how to present a provision for uncertain tax positions in the financial statements when a net operating loss carryforward, a similar tax loss, or a tax credit carryforward exists. For public entities, the amendments are effective for fiscal years and interim reporting periods beginning after December 15, 2013. The Company does not believe that the adoption of this standard will have a material impact on its consolidated financial statements.</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Use of Estimates</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">The preparation of financial statements in conformity with accounting principles generally accepted in the United States (&#8220;GAAP&#8221;) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, 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.&#160;&#160;Actual results could differ from those estimates.</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Cash and Cash Equivalents</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Of the $14.3 million and $25.7 million of cash and cash equivalents at September 30, 2013 and December 31, 2012, respectively, $1.5 million and $13.0 million, respectively, consisted of highly liquid investments with maturities of 90 days or&#160;less when purchased.&#160; These investments&#160;consist of commercial paper, short-term debt securities,&#160;time deposits and investments in money market funds with commercial banks and financial institutions. As of September 30, 2013, $3.5 million of the Company's&#160;cash and cash equivalents&#160;was restricted to the use of its majority-owned subsidiaries, leaving $10.8 million available for general use.</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Short-Term Investments</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">The Company&#8217;s short-term investments are classified as held to maturity given the intent and ability to hold the investments to maturity. Accordingly, these investments are carried at amortized cost. Short-term investments classified as held-to-maturity consisted of certificates of deposit with maturity dates beyond three months and less than one year. As of September 30, 2013, all of the Company&#8217;s short-term investments were restricted to use by its majority-owned subsidiaries.</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"> <font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Significant Customers and Accounts Receivable</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Grant and contract revenue from the U.S. government accounted for 48.1% and 39.5% of total revenue for the three and nine months ended September 30, 2013, respectively, and 23.2% and 88.0% of total revenue for the three and nine months ended September 30, 2012, respectively.</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Grant and contract revenue received by the Company&#8217;s subsidiaries from Russian government agencies accounted for 51.9% and 60.5% of total consolidated revenues for the three and nine months ended September 30, 2013, respectively, and 76.8% and 12.0% of total consolidated revenue for the three and nine months ended September 30, 2012, respectively.</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Although the Company anticipates ongoing U.S. and Russian government contract and grant revenue, there is no guarantee that these revenue streams will continue in the future.</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Accounts receivable consist of amounts due under reimbursement contracts with certain government and foreign entities. The Company extends unsecured credit to customers under normal trade agreements, which generally require payment within 30 days.</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Management estimates an allowance for doubtful accounts that is based upon management's review of delinquent accounts and an assessment of the Company's historical evidence of collections. There were no allowances for doubtful accounts as of September 30, 2013 and December 31, 2012, as the collection history from the Company&#8217;s customers indicated that collection was probable.</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Intellectual Property</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Costs related to filing and pursuing patent applications are recognized as general and administrative expenses (&#8220;G&amp;A expenses&#8221;) as incurred, since the recoverability of such expenditures is uncertain. Upon marketing approval by the U.S. Food and Drug Administration (&#8220;FDA&#8221;) or a respective foreign governing body, such costs will be capitalized and depreciated over the expected life of the related patent.</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Accounting for Stock-Based Compensation</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">The 2006 Equity Incentive Plan, as amended (the &#8220;Plan&#8221;), authorizes CBLI to grant (i) options to purchase common stock, (ii) restricted or unrestricted stock units, and (iii) stock appreciation rights, so long as the exercise or grant price of each are at least equal to the fair market value of the stock on the date of grant. As of September 30, 2013, an aggregate of 10.0 million shares of common stock were authorized for issuance under the Plan, of which a total of approximately 2.1 million shares of common stock remained available for future awards. A single participant cannot be awarded more than 400,000 shares annually. Awards granted under the Plan have a contractual life of no more than 10 years. The terms and conditions of equity awards (such as price, vesting schedule, term and number of shares) under the Plan are specified in an award document, and approved by the Company&#8217;s compensation committee.</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">In June 2013 the Company&#8217;s stockholders approved the 2013 Employee Stock Purchase Plan (&#8220;ESPP&#8221;) which provides a means by which eligible employees of the Company and certain designated related corporations may be given an opportunity to purchase shares of Common Stock. As of September 30, 2013, there are 2.1 million shares of Common Stock reserved for purchase under the ESPP. The number of shares reserved for purchase under the ESPP increases on January 1 of each calendar year by the lesser of (i) 10% of the total number of shares of Common Stock outstanding on December 31<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">st</font> of the preceding year, or (ii) 200,000 shares of Common Stock. 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All significant intercompany balances and transactions have been eliminated in consolidation.</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">The unaudited consolidated financial statements included herein have been prepared in accordance with U.S.&#160;generally accepted accounting principles for interim financial information and in accordance with the instructions to Form&#160;10-Q and Article&#160;10 of Regulation&#160;S-X of the Securities and Exchange Commission ("SEC"). Certain information and footnote disclosures normally included in consolidated financial statements prepared in accordance with U.S.&#160;generally accepted accounting principles have been condensed or omitted pursuant to such rules and regulations. These consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto contained in the Company&#8217;s Annual Report on Form&#160;10-K for the year ended December&#160;31, 2012, as amended, as filed with the SEC..</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">In the opinion of the Company&#8217;s management, any adjustments contained in the accompanying unaudited consolidated financial statements are of a normal recurring nature, and are necessary to present fairly the financial position of the Company as of September 30, 2013, along with its results of operations for the three and nine month periods ended September 30, 2013 and 2012 and cash flows for the nine month periods ended September 30, 2013 and 2012.&#160;&#160;Interim results are not necessarily indicative of results that may be expected for any other interim period or for an entire year.</font></div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Recent Accounting Pronouncements</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">In July 2013, the FASB issued ASU No.&#160;2013-11, &#8220;Income Taxes (Topic 740): Presentation of an Unrecognized Tax Benefit When a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists (a consensus of the FASB Emerging Issues Task Force)&#8221; (&#8220;ASU 2013-11&#8221;). The amendments of ASU 2013-11 provide entities with guidance of how to present a provision for uncertain tax positions in the financial statements when a net operating loss carryforward, a similar tax loss, or a tax credit carryforward exists. For public entities, the amendments are effective for fiscal years and interim reporting periods beginning after December 15, 2013. The Company does not believe that the adoption of this standard will have a material impact on its consolidated financial statements.</font></div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Use of Estimates</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">The preparation of financial statements in conformity with accounting principles generally accepted in the United States (&#8220;GAAP&#8221;) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, 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.&#160;&#160;Actual results could differ from those estimates.</font></div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Cash and Cash Equivalents</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Of the $14.3 million and $25.7 million of cash and cash equivalents at September 30, 2013 and December 31, 2012, respectively, $1.5 million and $13.0 million, respectively, consisted of highly liquid investments with maturities of 90 days or&#160;less when purchased.&#160; These investments&#160;consist of commercial paper, short-term debt securities,&#160;time deposits and investments in money market funds with commercial banks and financial institutions. As of September 30, 2013, $3.5 million of the Company's&#160;cash and cash equivalents&#160;was restricted to the use of its majority-owned subsidiaries, leaving $10.8 million available for general use.</font></div> 1500000 13000000 P90D 3500000 10800000 <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Short-Term Investments</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">The Company&#8217;s short-term investments are classified as held to maturity given the intent and ability to hold the investments to maturity. Accordingly, these investments are carried at amortized cost. Short-term investments classified as held-to-maturity consisted of certificates of deposit with maturity dates beyond three months and less than one year. As of September 30, 2013, all of the Company&#8217;s short-term investments were restricted to use by its majority-owned subsidiaries.</font></div> P3M P1Y <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Significant Customers and Accounts Receivable</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Grant and contract revenue from the U.S. government accounted for 48.1% and 39.5% of total revenue for the three and nine months ended September 30, 2013, respectively, and 23.2% and 88.0% of total revenue for the three and nine months ended September 30, 2012, respectively.</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Grant and contract revenue received by the Company&#8217;s subsidiaries from Russian government agencies accounted for 51.9% and 60.5% of total consolidated revenues for the three and nine months ended September 30, 2013, respectively, and 76.8% and 12.0% of total consolidated revenue for the three and nine months ended September 30, 2012, respectively.</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Although the Company anticipates ongoing U.S. and Russian government contract and grant revenue, there is no guarantee that these revenue streams will continue in the future.</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Accounts receivable consist of amounts due under reimbursement contracts with certain government and foreign entities. The Company extends unsecured credit to customers under normal trade agreements, which generally require payment within 30 days.</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Management estimates an allowance for doubtful accounts that is based upon management's review of delinquent accounts and an assessment of the Company's historical evidence of collections. There were no allowances for doubtful accounts as of September 30, 2013 and December 31, 2012, as the collection history from the Company&#8217;s customers indicated that collection was probable.</font></div> 0.481 0.395 0.232 0.880 0.519 0.605 0.768 0.120 P30D <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Intellectual Property</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Costs related to filing and pursuing patent applications are recognized as general and administrative expenses (&#8220;G&amp;A expenses&#8221;) as incurred, since the recoverability of such expenditures is uncertain. Upon marketing approval by the U.S. Food and Drug Administration (&#8220;FDA&#8221;) or a respective foreign governing body, such costs will be capitalized and depreciated over the expected life of the related patent.</font></div> <div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Accounting for Stock-Based Compensation</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">The 2006 Equity Incentive Plan, as amended (the &#8220;Plan&#8221;), authorizes CBLI to grant (i) options to purchase common stock, (ii) restricted or unrestricted stock units, and (iii) stock appreciation rights, so long as the exercise or grant price of each are at least equal to the fair market value of the stock on the date of grant. As of September 30, 2013, an aggregate of 10.0 million shares of common stock were authorized for issuance under the Plan, of which a total of approximately 2.1 million shares of common stock remained available for future awards. A single participant cannot be awarded more than 400,000 shares annually. Awards granted under the Plan have a contractual life of no more than 10 years. The terms and conditions of equity awards (such as price, vesting schedule, term and number of shares) under the Plan are specified in an award document, and approved by the Company&#8217;s compensation committee.</font> </div><br/><div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"> <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">In June 2013 the Company&#8217;s stockholders approved the 2013 Employee Stock Purchase Plan (&#8220;ESPP&#8221;) which provides a means by which eligible employees of the Company and certain designated related corporations may be given an opportunity to purchase shares of Common Stock. As of September 30, 2013, there are 2.1 million shares of Common Stock reserved for purchase under the ESPP. 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Disclosure - Note 4 - Debt (Tables) link:presentationLink link:definitionLink link:calculationLink 017 - Disclosure - Note 5 - Stockholders' Equity (Tables) link:presentationLink link:definitionLink link:calculationLink 018 - Disclosure - Note 1 - Description of Business (Details) link:presentationLink link:definitionLink link:calculationLink 019 - Disclosure - Note 2 - Summary of Significant Accounting Policies (Details) link:presentationLink link:definitionLink link:calculationLink 020 - Disclosure - Note 2 - Summary of Significant Accounting Policies (Details) - Assumptions used in valuing the stock options granted: link:presentationLink link:definitionLink link:calculationLink 021 - Disclosure - Note 2 - Summary of Significant Accounting Policies (Details) - The Company has excluded the following outstanding warrants and options from the calculation of diluted earnings per share link:presentationLink link:definitionLink link:calculationLink 022 - Disclosure - Note 3 - Fair Value of Financial Instruments (Details) - Fair value hierarchy for its financial liabilities: link:presentationLink link:definitionLink link:calculationLink 023 - Disclosure - Note 3 - Fair Value of Financial Instruments (Details) - Black-Scholes model to measure accrued warrant liability and stock options: link:presentationLink link:definitionLink link:calculationLink 024 - Disclosure - Note 3 - Fair Value of Financial Instruments (Details) - Assumptions used to measure the compensatory stock options not yet issued: link:presentationLink link:definitionLink link:calculationLink 025 - Disclosure - Note 3 - Fair Value of Financial Instruments (Details) - Summary of changes in the fair value of the Company’s Level 3 fair value measurements: link:presentationLink link:definitionLink link:calculationLink 026 - Disclosure - Note 3 - Fair Value of Financial Instruments (Details) - Table summarizing the unobservable inputs into the fair value measurements: link:presentationLink link:definitionLink link:calculationLink 027 - Disclosure - Note 4 - Debt (Details) link:presentationLink link:definitionLink link:calculationLink 028 - Disclosure - Note 4 - Debt (Details) - Warrant fair value assumptions link:presentationLink link:definitionLink link:calculationLink 029 - Disclosure - Note 4 - Debt (Details) - Summary of principal payments link:presentationLink link:definitionLink link:calculationLink 030 - Disclosure - Note 5 - Stockholders' Equity (Details) link:presentationLink link:definitionLink link:calculationLink 031 - Disclosure - Note 5 - Stockholders' Equity (Details) - Summary of option award activity under the Equity Incentive Plan: link:presentationLink link:definitionLink link:calculationLink 032 - Disclosure - Note 5 - Stockholders' Equity (Details) - Summary of outstanding stock options under the Plan: link:presentationLink link:definitionLink link:calculationLink 033 - Disclosure - Note 6 - Warrants (Details) link:presentationLink link:definitionLink link:calculationLink 000 - Disclosure - Document And Entity Information link:presentationLink link:definitionLink link:calculationLink EX-101.CAL 9 cbli-20130930_cal.xml XBRL TAXONOMY EXTENSION CALCULATION LINKBASE EX-101.DEF 10 cbli-20130930_def.xml XBRL TAXONOMY EXTENSION DEFINITION LINKBASE EX-101.LAB 11 cbli-20130930_lab.xml XBRL TAXONOMY EXTENSION LABEL LINKBASE EX-101.PRE 12 cbli-20130930_pre.xml XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE XML 13 R17.htm IDEA: XBRL DOCUMENT v2.4.0.8
Note 4 - Debt (Tables)
9 Months Ended
Sep. 30, 2013
Debt Disclosure [Abstract]  
Schedule of Assumptions Used [Table Text Block]
 
Risk-free interest rate
    0.48 %  
 
Expected dividend yield
    0.00 %  
 
Expected life (years)
    2.50    
 
Expected volatility
    82.29 %  
Schedule of Maturities of Long-term Debt [Table Text Block]
 
2013
  $ -    
 
2014
    351,527    
 
2015
    2,246,215    
 
2016
    2,495,163    
 
2017
    1,457,095    
 
Total
  $ 6,550,000    
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Consolidated Statements of Operations (Unaudited) (USD $)
3 Months Ended 9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Sep. 30, 2013
Sep. 30, 2012
Revenues:        
Grants and contracts $ 1,635,600 $ 219,575 $ 4,616,334 $ 1,409,209
Operating expenses:        
Research and development 4,205,238 4,841,324 14,909,882 16,920,400
General and administrative 3,286,830 3,219,792 9,787,053 8,973,949
Total operating expenses 7,492,068 8,061,116 24,696,935 25,894,349
Loss from operations (5,856,468) (7,841,541) (20,080,601) (24,485,140)
Other income (expense):        
Interest and other income 97,534 228,580 225,299 354,473
Foreign exchange gain (loss) (15,057) (278,940) 59,853 (330,024)
Change in value of warrant liability 1,163,030 (4,423,775) 510,919 (160,749)
Total other income (expense) 1,245,507 (4,474,135) 796,071 (136,300)
Net loss (4,610,961) (12,315,676) (19,284,530) (24,621,440)
Net loss attributable to noncontrolling interests 519,765 1,437,840 2,386,900 3,277,774
Net loss attributable to Cleveland BioLabs, Inc. $ (4,091,196) $ (10,877,836) $ (16,897,630) $ (21,343,666)
Net loss available to common stockholders per share of common stock, basic and diluted (in Dollars per share) $ (0.09) $ (0.30) $ (0.38) $ (0.60)
Weighted average number of shares used in calculating net loss per share, basic and diluted (in Shares) 45,061,274 35,879,245 44,946,340 35,761,260

XML 16 R10.htm IDEA: XBRL DOCUMENT v2.4.0.8
Note 3 - Fair Value of Financial Instruments
9 Months Ended
Sep. 30, 2013
Fair Value Disclosures [Abstract]  
Fair Value Disclosures [Text Block]
3.  Fair Value of Financial Instruments

The Company measures and records warrant liabilities at fair value in the accompanying financial statements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability, an exit price, in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value, includes:

Level 1 - Observable inputs for identical assets or liabilities such as quoted prices in active markets;

Level 2 - Inputs other than quoted prices in active markets that are either directly or indirectly observable; and

Level 3 - Unobservable inputs in which little or no market data exists, which are therefore developed by the Company using estimates and assumptions that reflect those that a market participant would use.

The following tables represent the Company’s fair value hierarchy for its financial liabilities measured at fair value on a recurring basis as of September 30, 2013 and December 31, 2012:

   
As of September 30, 2013
 
   
Level 1
   
Level 2
   
Level 3
   
Total
 
Liabilities:
                       
Compensatory stock options not yet issued (1)
  $ -     $ -     $ 166,783     $ 166,783  
Accrued warrant liability
    -       -       3,594,741       3,594,741  
                                 
Total liabilities
  $ -     $ -     $ 3,761,524     $ 3,761,524  

   
As of December 31, 2012
 
   
Level 1
   
Level 2
   
Level 3
   
Total
 
Liabilities:
                       
Accrued warrant liability
  $ -     $ -     $ 4,105,659     $ 4,105,659  
                                 
Total liabilities
  $ -     $ -     $ 4,105,659     $ 4,105,659  

 (1) Included in accrued expenses in the accompanying consolidated balance sheets.

The Company uses the Black-Scholes model to measure the accrued warrant liability and its accrual for compensatory stock options not yet issued. The following are the assumptions used to measure the accrued warrant liability at September 30, 2013 and December 31, 2012, which were determined in a manner consistent with that described for grants of options to purchase common stock as set forth in Note 2:

   
September 30, 2013
   
December 31, 2012
 
             
Stock Price
  $     1.57     $     1.33  
Exercise Price
  $ 1.60 - 5.00     $ 1.60 - 5.00  
Term in years
    0.71 - 2.03       1.09 - 2.41  
Volatility
    48.41 - 79.57 %     82.75 - 95.91 %
Annual rate of quarterly dividends
        0 %         0 %
Discount rate- bond equivalent yield
    .07 - .34 %     .17 - .29 %

The following are the assumptions used to measure the compensatory stock options not yet issued at September 30, 2013:

     
September 30, 2013
   
           
 
Stock price
  $ 1.57    
 
Term in years
    5    
 
Volatility
    79.93 %  
 
Annual rate of quarterly dividends
    0 %  
 
Discount rate - bond equivalent yield
    1.40 %  

The following table sets forth a summary of changes in the fair value of the Company’s Level 3 fair value measurements for the nine months ended September 30, 2013 and 2012: 

   
Three months ended September 30, 2013
   
Nine months ended September 30, 2013
 
   
Accrued Warrant
Liability
      Compensatory
Stock Options
Not Yet Issued
    Accrued Warrant
Liability
   
Compensatory
Stock Options
Not Yet Issued
 
                         
Beginning balance
  $ 4,757,770     $ 63,838     $ 4,105,659     $ -  
Total (gains) or losses, realized and unrealized, included in earnings (1)(2)
    (1,163,029 )     -       (510,918 )     -  
Estimates and other changes in fair value
    -       102,945       -       166,783  
Settlements
    -       -       -       -  
                                 
Balance, September 30, 2013
  $ 3,594,741     $ 166,783     $ 3,594,741     $ 166,783  

   
Three months ended September 30, 2012
   
Nine months ended September 30, 2012
 
     
Accrued Warrant
Liability
      Compensatory
Stock Options
Not Yet Issued
     
Accrued Warrant
Liability
   
Compensatory
Stock Options
Not Yet Issued
 
                         
Beginning balance
  $ 3,022,933     $ 114,617     $ 7,285,959     $ 378,750  
Total (gains) or losses, realized and unrealized, included in earnings (1)(2)
    4,423,775       -       160,749       51,823  
Estimates and other changes in fair value
    -       169,708       -       284,325  
Settlements
    -       -       -       (430,573 )
                                 
Balance, September 30, 2012
  $ 7,446,708     $ 284,325     $ 7,446,708     $ 284,325  

(1)
Unrealized gains or losses related to the accrued warrant liability were included as change in value of accrued warrant liability. There were no realized gains or losses for the three and nine month periods ended September 30, 2013 and 2012.

(2)
Expenses recorded for compensatory stock options not yet issued are included in research & development expense and general and administrative expense.

As of September 30, 2013 and December 31, 2012, the Company had no assets or liabilities that were measured at fair value on a nonrecurring basis.

The Company considers the accrued warrant liability and compensatory stock options not yet issued to be Level 3 because some of the inputs into the measurements are neither directly or indirectly observable. Both the accrued warrant liability and compensatory stock options not yet issued use management’s estimate for the expected term, which is based on the safe harbor method as historical exercise information over the term of each security is not readily available. Additionally, the number of compensatory options awarded involves an estimate of management’s performance in relation to the targets set forth in the Company's Executive Compensation Plan. The following table summarizes the unobservable inputs into the fair value measurements:

   
September 30, 2013
 
Description
 
Fair Value
   
Valuation Technique
 
Unobservable Input
 
Range
 
                     
Compensatory stock options not yet issued
  $ 166,783    
Black-scholes pricing model
 
Expected term
    5  
               
Quantity of options
    220,833  
                         
Accrued warrant liability
    3,594,741    
Black-scholes pricing model
 
Expected term
    0.71   -   2.03  
                         
    $ 3,761,524                  

Management believes the value of both the accrued warrant liability and compensatory stock options is more sensitive to a change in the Company’s stock price at the end of the respective reporting period as opposed to a change in one of the unobservable inputs described above.

The carrying amounts of the Company’s short-term financial instruments, which include cash and cash equivalents, short-term investments, accounts receivable and accounts payable, approximate their fair values due to their short maturities.

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Note 3 - Fair Value of Financial Instruments (Details) - Black-Scholes model to measure accrued warrant liability and stock options: (USD $)
9 Months Ended 12 Months Ended
Sep. 30, 2013
Dec. 31, 2012
Note 3 - Fair Value of Financial Instruments (Details) - Black-Scholes model to measure accrued warrant liability and stock options: [Line Items]    
Stock Price (in Dollars per share) $ 1.57  
Term in years 5 years  
Volatility 79.93%  
Annual rate of quarterly dividends 0.00%  
Discount rate- bond equivalent yield 1.40%  
Minimum [Member]
   
Note 3 - Fair Value of Financial Instruments (Details) - Black-Scholes model to measure accrued warrant liability and stock options: [Line Items]    
Exercise Price (in Dollars per share) $ 1.60 $ 1.60
Term in years 259 days 1 year 32 days
Volatility 48.41% 82.75%
Discount rate- bond equivalent yield 0.07% 0.17%
Maximum [Member]
   
Note 3 - Fair Value of Financial Instruments (Details) - Black-Scholes model to measure accrued warrant liability and stock options: [Line Items]    
Stock Price (in Dollars per share) $ 1.57 $ 1.33
Exercise Price (in Dollars per share) $ 5.00 $ 5.00
Term in years 2 years 10 days 2 years 149 days
Volatility 79.57% 95.91%
Annual rate of quarterly dividends 0.00% 0.00%
Discount rate- bond equivalent yield 0.34% 0.29%
XML 19 R18.htm IDEA: XBRL DOCUMENT v2.4.0.8
Note 5 - Stockholders' Equity (Tables)
9 Months Ended
Sep. 30, 2013
Stockholders' Equity Note [Abstract]  
Schedule of Share-based Compensation, Stock Options, Activity [Table Text Block]
   
Nine months ended September 30, 2013
 
   
Total Stock
Options
Outstanding
   
Weighted Average
Exercise Price per
Share
   
Nonvested Stock
Options
   
Weighted Average
Grant Date Fair
Value per Share
 
                         
December 31, 2012
    5,016,916     $ 4.54       404,500     $ 2.30  
Granted
    898,604       1.67       898,604       1.21  
Vested
    -       -       (506,875 )     1.69  
Exercised
    (9,681 )     1.28       -       -  
Forfeited, Canceled
    (296,927 )     3.66       (151,250 )     0.97  
                                 
September 30, 2013
    5,608,912     $ 4.13       644,979     $ 1.56  
Schedule of Share-based Compensation, Activity [Table Text Block]
   
As of September 30, 2013
 
   
Stock Options
Outstanding
   
Vested Stock
 Options
 
             
Quantity
    5,608,912       4,963,933  
Weighted-average exercise price
  $ 4.13     $ 4.39  
Weighted Average Remaining Contractual Term (in Years)
    7.01       6.72  
Intrinsic value
  $ 134,340     $ 122,487  
XML 20 R27.htm IDEA: XBRL DOCUMENT v2.4.0.8
Note 3 - Fair Value of Financial Instruments (Details) - Table summarizing the unobservable inputs into the fair value measurements: (USD $)
9 Months Ended
Sep. 30, 2013
Sep. 29, 2013
Dec. 31, 2012
Note 3 - Fair Value of Financial Instruments (Details) - Table summarizing the unobservable inputs into the fair value measurements: [Line Items]      
Fair Value (in Dollars) $ 3,761,524    
Valuation Technique
     
For the nine months ended September 30,
   
 
 
 
2013
   
2012
   
                 
 
Risk-free interest rate
    0.02 - 1.92 %     0.71 - 1.49 %  
 
Expected dividend yield
        0 %         0 %  
 
Expected life (in years)
    5 - 7.3       5 - 6    
 
Expected volatility
    80.71 - 89.66 %     86.58 - 92.24 %  
   
Range 2 years 6 months    
(in Shares) 220,833 5,608,912 5,016,916
Quantity of options    
Employee Stock Option [Member]
     
Note 3 - Fair Value of Financial Instruments (Details) - Table summarizing the unobservable inputs into the fair value measurements: [Line Items]      
Fair Value (in Dollars) 166,783    
Valuation Technique Black-scholes pricing model    
Unobservable Input Expected term    
Range 5 years    
(in Shares) 5,608,912    
Warrants Outstanding [Member]
     
Note 3 - Fair Value of Financial Instruments (Details) - Table summarizing the unobservable inputs into the fair value measurements: [Line Items]      
Fair Value (in Dollars) $ 3,594,741    
Valuation Technique Black-scholes pricing model    
Unobservable Input Expected term    
Range 259 days    
Warrants Outstanding [Member] | Maximum [Member]
     
Note 3 - Fair Value of Financial Instruments (Details) - Table summarizing the unobservable inputs into the fair value measurements: [Line Items]      
Range 2 years 10 days    
XML 21 R26.htm IDEA: XBRL DOCUMENT v2.4.0.8
Note 3 - Fair Value of Financial Instruments (Details) - Summary of changes in the fair value of the Company’s Level 3 fair value measurements: (USD $)
9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Accrued Warrant Liability [Member] | Three Months [Member]
   
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]    
Beginning balance $ 4,757,770 $ 3,022,933
Total (gains) or losses, realized and unrealized, included in earnings (1)(2) (1,163,029) [1],[2] 4,423,775 [1],[2]
Balance, 3,594,741 7,446,708
Accrued Warrant Liability [Member] | Nine Months [Member]
   
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]    
Beginning balance 4,105,659 7,285,959
Total (gains) or losses, realized and unrealized, included in earnings (1)(2) (510,918) [1],[2] 160,749 [1],[2]
Balance, 3,594,741 7,446,708
Compensatory Stock Options Not Yet Issued [Member] | Three Months [Member]
   
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]    
Beginning balance 63,838 114,617
Total (gains) or losses, realized and unrealized, included in earnings (1)(2)    [1],[2]    [1],[2]
Estimates and other changes in fair value 102,945 169,708
Balance, 166,783 284,325
Compensatory Stock Options Not Yet Issued [Member] | Nine Months [Member]
   
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]    
Beginning balance   378,750
Total (gains) or losses, realized and unrealized, included in earnings (1)(2)    [1],[2] 51,823 [1],[2]
Estimates and other changes in fair value 166,783 284,325
Settlements   (430,573)
Balance, $ 166,783 $ 284,325
[1] Unrealized gains or losses related to the accrued warrant liability were included as change in value of accrued warrant liability. There were no realized gainsor losses for the three and nine month periods ended September 30, 2013 and 2012.
[2] Expenses recorded for compensatory stock options not yet issued are included in research & development expense and general and administrative expense.
XML 22 R34.htm IDEA: XBRL DOCUMENT v2.4.0.8
Note 6 - Warrants (Details)
9 Months Ended
Sep. 30, 2013
Note 6 - Warrants (Details) [Line Items]  
Class of Warrant or Right, Exercise Price of Warrants or Rights 2.70
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in Shares) 10,534,245
Original Per Share Amount [Member] | Rusnano Loan [Member]
 
Note 6 - Warrants (Details) [Line Items]  
Class of Warrant or Right, Exercise Price of Warrants or Rights 2.00
Revised Per Share Amount [Member] | Rusnano Loan [Member]
 
Note 6 - Warrants (Details) [Line Items]  
Class of Warrant or Right, Exercise Price of Warrants or Rights 1.694
Reduction In Exercise Price After Closing Of Hercules Loan [Member] | Hercules Loan [Member]
 
Note 6 - Warrants (Details) [Line Items]  
Class of Warrant or Right, Exercise Price of Warrants or Rights 1.60
Minimum [Member]
 
Note 6 - Warrants (Details) [Line Items]  
Class of Warrant or Right, Exercise Price of Warrants or Rights 1.60
Warrant Expiration Term 1 year
Maximum [Member]
 
Note 6 - Warrants (Details) [Line Items]  
Class of Warrant or Right, Exercise Price of Warrants or Rights 5.00
Warrant Expiration Term 7 years
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Note 5 - Stockholders' Equity (Details) (USD $)
9 Months Ended
Sep. 29, 2013
Sep. 30, 2013
Sep. 30, 2012
Stockholders' Equity Note [Abstract]      
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross (in Shares) 898,604 898,604 739,500
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value (in Dollars per share) $ 1.21 $ 1.21 $ 1.53
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value   $ 858,037 $ 1,246,720
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period, Intrinsic Value   5,736 1,500
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized   $ 606,070  
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition   310 days  

XML 25 R25.htm IDEA: XBRL DOCUMENT v2.4.0.8
Note 3 - Fair Value of Financial Instruments (Details) - Assumptions used to measure the compensatory stock options not yet issued: (USD $)
9 Months Ended
Sep. 30, 2013
Assumptions used to measure the compensatory stock options not yet issued: [Abstract]  
Stock price (in Dollars per share) $ 1.57
Term in years 5 years
Volatility 79.93%
Annual rate of quarterly dividends 0.00%
Discount rate - bond equivalent yield 1.40%
XML 26 R6.htm IDEA: XBRL DOCUMENT v2.4.0.8
Consolidated Statement of Stockholders' Equity (Deficit) (Unaudited) (USD $)
Common Stock [Member]
Additional Paid-in Capital [Member]
Accumulated Other Comprehensive Income (Loss) [Member]
Retained Earnings [Member]
Noncontrolling Interest [Member]
Total
Balance at Dec. 31, 2012 $ 223,653 $ 123,864,830 $ 546,473 $ (118,301,789) $ 14,152,541 $ 20,485,708
Balance (in Shares) at Dec. 31, 2012 44,730,445          
Stock based compensation 2,085 1,403,648       1,405,733
Stock based compensation (in Shares) 416,988          
Exercise of options 48 12,344       12,392
Exercise of options (in Shares) 9,681          
Allocation of debt proceeds to fair value of warrants   117,999       117,999
Net loss       (16,897,630) (2,386,900) (19,284,530)
Foreign currency translation     (239,059)   (165,189) (404,248)
Balance at Sep. 30, 2013 $ 225,786 $ 125,398,821 $ 307,414 $ (135,199,419) $ 11,600,452 $ 2,333,054
Balance (in Shares) at Sep. 30, 2013 45,157,114          
XML 27 R8.htm IDEA: XBRL DOCUMENT v2.4.0.8
Note 1 - Description of Business
9 Months Ended
Sep. 30, 2013
Disclosure Text Block [Abstract]  
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block]
1. Description of Business

Cleveland BioLabs, Inc. (“CBLI”) is a clinical-stage biotechnology company with a focus on oncology and acute radiation syndrome drug development. Since inception, CBLI has pursued the research, development and commercialization of products that have the potential to treat cancer, reduce death from total body irradiation and counteract the toxic effects of radio- and chemotherapies for oncology patients.

CBLI is incorporated under the laws of the State of Delaware and is headquartered in Buffalo, New York. CBLI has one wholly-owned operating subsidiary, BioLab 612, LLC (“BioLab 612”), which began operations in 2012. CBLI also has two majority-owned operating subsidiaries, Incuron, LLC (“Incuron”) and Panacela Labs, Inc. (“Panacela”), which were formed in 2010 and 2011, respectively. Additionally, Panacela has a wholly-owned operating subsidiary, Panacela Labs, LLC.

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Note 4 - Debt
9 Months Ended
Sep. 30, 2013
Debt Disclosure [Abstract]  
Debt Disclosure [Text Block]
4. Debt

On September 30, 2013, CBLI entered into a Loan and Security Agreement (the “Loan Agreement”) with Hercules Technology II, L.P. (“Hercules”) pursuant to which the company issued a $6 million note and received net proceeds of $5.9 million. The loan bears interest at the greater of (i) 10.45% per annum or (ii) 10.45% plus the prevailing prime rate minus 4.25%. The loan matures on January 1, 2017, and requires interest-only payments for the initial 12 months and principal and interest payments in 27 monthly installments thereafter.  If, prior to June 30, 2014, and subject to Hercules’ approval, CBLI obtains a contract award from the Biomedical Advanced Research Development Authority (“BARDA”) or other funding sources sufficient to fund a series of studies for Entolimod as a radiation countermeasure, which would reasonably be expected to provide a basis for submitting a Biological License Application (“BLA”) to the FDA for licensure of Entolimod as a radiation countermeasure, CBLI may obtain an additional $4 million in loan proceeds at its option.

In connection with the Loan Agreement, CBLI granted a first priority lien in substantially all of CBLI’s assets (exclusive of intellectual property). The Loan Agreement also contains representations and warranties by CBLI and Hercules, indemnification provisions in favor of Hercules, customary covenants (including limitations on other indebtedness, liens, acquisitions, investments and dividends, and not including financial covenants), and events of default (including payment defaults, breaches of covenants, material adverse events and events leading to bankruptcy or insolvency). Prepayment of the loan is subject to a penalty rate applied to the balance of the secured obligation and ranges from 1% to 3% based on the date the loan is prepaid. Additionally, Hercules has a right to participate in subsequent private placements of CBLI equity securities at the same price, terms and conditions as other investors, up to an aggregate amount of $1 million.

As additional consideration for the loan, CBLI issued Hercules a five-year warrant to purchase 156,250 shares of CBLI common stock at an exercise price of $1.60 per share. CBLI recorded the fair value of the warrant of $117,999 as equity and as a discount to the carrying value of the loan.  The fair value of the warrant was calculated using the Black-Scholes option pricing model with the following assumptions:

 
Risk-free interest rate
    0.48 %  
 
Expected dividend yield
    0.00 %  
 
Expected life (years)
    2.50    
 
Expected volatility
    82.29 %  

Reflected as a discount to the loan are the following items: the warrant, a $100,000 facility fee CBLI paid to Hercules which was deducted from the gross proceeds of the loan, and a $550,000 payment that is due upon full repayment of the loan or on the maturity date, whichever occurs sooner. In connection with the closing of the loan, CBLI incurred $102,000 in debt issuance costs, primarily related to legal fees, which are included in non-current assets in our consolidated balance sheet. CBLI will amortize the loan discounts and debt issuance costs to interest expense over the term of the loan using the effective interest rate method, which approximates 16.6%. Additionally, the $550,000 end-of-term charge is also reflected as a long-term liability in conjunction with the $6 million note.

The following schedule shows the payments for principal and the end of term charge on the loan by calendar year:

 
2013
  $ -    
 
2014
    351,527    
 
2015
    2,246,215    
 
2016
    2,495,163    
 
2017
    1,457,095    
 
Total
  $ 6,550,000    

On September 3, 2013, Panacela entered into a Master Agreement (the “Panacela Loan”) with Open Joint Stock Company “Rusnano” and CBLI pursuant to which Panacela issued a $1,530,000 note to Rusnano. The Panacela Loan bears interest at a rate of 16.3% per annum and matures on September 3, 2015, at which time Panacela must repay all unpaid principal and accrued interest. Prior to March 3, 2015, the loan is mandatorily convertible into shares of Panacela preferred stock at a conversion price of $1,057 per share if Panacela completes a qualified financing in accordance with the terms of the Panacela Loan.  Subsequent to March 3, 2015, Rusnano has the option to convert the unpaid principal plus interest into shares of Panacela Preferred Stock at a conversion price of $1,057 per share, or if Panacela has a qualified financing event, at a discounted price of 0.75 times the purchase price per share.

In connection with the Panacela Loan, CBLI issued Rusnano a warrant  that has an exercise period that begins upon an event of default on the Panacela Loan and expires on December 31, 2016. Upon an event of default, Rusnano has the option to assign 69.2% of the unpaid principal and interest under the Panacela Loan to CBLI in exchange for shares of CBLI common stock at a price of $1.694 per share.

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Note 2 - Summary of Significant Accounting Policies
9 Months Ended
Sep. 30, 2013
Accounting Policies [Abstract]  
Significant Accounting Policies [Text Block]
2. Summary of Significant Accounting Policies

Basis of Presentation and Consolidation

The accompanying consolidated financial statements include the accounts of CBLI and its subsidiaries, BioLab 612, Incuron and Panacela, collectively referred to herein as the “Company.” All significant intercompany balances and transactions have been eliminated in consolidation.

The unaudited consolidated financial statements included herein have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission ("SEC"). Certain information and footnote disclosures normally included in consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles have been condensed or omitted pursuant to such rules and regulations. These consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012, as amended, as filed with the SEC..

In the opinion of the Company’s management, any adjustments contained in the accompanying unaudited consolidated financial statements are of a normal recurring nature, and are necessary to present fairly the financial position of the Company as of September 30, 2013, along with its results of operations for the three and nine month periods ended September 30, 2013 and 2012 and cash flows for the nine month periods ended September 30, 2013 and 2012.  Interim results are not necessarily indicative of results that may be expected for any other interim period or for an entire year.

Recent Accounting Pronouncements

In July 2013, the FASB issued ASU No. 2013-11, “Income Taxes (Topic 740): Presentation of an Unrecognized Tax Benefit When a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists (a consensus of the FASB Emerging Issues Task Force)” (“ASU 2013-11”). The amendments of ASU 2013-11 provide entities with guidance of how to present a provision for uncertain tax positions in the financial statements when a net operating loss carryforward, a similar tax loss, or a tax credit carryforward exists. For public entities, the amendments are effective for fiscal years and interim reporting periods beginning after December 15, 2013. The Company does not believe that the adoption of this standard will have a material impact on its consolidated financial statements.

Use of Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, 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.  Actual results could differ from those estimates.

Cash and Cash Equivalents

Of the $14.3 million and $25.7 million of cash and cash equivalents at September 30, 2013 and December 31, 2012, respectively, $1.5 million and $13.0 million, respectively, consisted of highly liquid investments with maturities of 90 days or less when purchased.  These investments consist of commercial paper, short-term debt securities, time deposits and investments in money market funds with commercial banks and financial institutions. As of September 30, 2013, $3.5 million of the Company's cash and cash equivalents was restricted to the use of its majority-owned subsidiaries, leaving $10.8 million available for general use.

Short-Term Investments

The Company’s short-term investments are classified as held to maturity given the intent and ability to hold the investments to maturity. Accordingly, these investments are carried at amortized cost. Short-term investments classified as held-to-maturity consisted of certificates of deposit with maturity dates beyond three months and less than one year. As of September 30, 2013, all of the Company’s short-term investments were restricted to use by its majority-owned subsidiaries.

Significant Customers and Accounts Receivable

Grant and contract revenue from the U.S. government accounted for 48.1% and 39.5% of total revenue for the three and nine months ended September 30, 2013, respectively, and 23.2% and 88.0% of total revenue for the three and nine months ended September 30, 2012, respectively.

Grant and contract revenue received by the Company’s subsidiaries from Russian government agencies accounted for 51.9% and 60.5% of total consolidated revenues for the three and nine months ended September 30, 2013, respectively, and 76.8% and 12.0% of total consolidated revenue for the three and nine months ended September 30, 2012, respectively.

Although the Company anticipates ongoing U.S. and Russian government contract and grant revenue, there is no guarantee that these revenue streams will continue in the future.

Accounts receivable consist of amounts due under reimbursement contracts with certain government and foreign entities. The Company extends unsecured credit to customers under normal trade agreements, which generally require payment within 30 days.

Management estimates an allowance for doubtful accounts that is based upon management's review of delinquent accounts and an assessment of the Company's historical evidence of collections. There were no allowances for doubtful accounts as of September 30, 2013 and December 31, 2012, as the collection history from the Company’s customers indicated that collection was probable.

Intellectual Property

Costs related to filing and pursuing patent applications are recognized as general and administrative expenses (“G&A expenses”) as incurred, since the recoverability of such expenditures is uncertain. Upon marketing approval by the U.S. Food and Drug Administration (“FDA”) or a respective foreign governing body, such costs will be capitalized and depreciated over the expected life of the related patent.

Accounting for Stock-Based Compensation

The 2006 Equity Incentive Plan, as amended (the “Plan”), authorizes CBLI to grant (i) options to purchase common stock, (ii) restricted or unrestricted stock units, and (iii) stock appreciation rights, so long as the exercise or grant price of each are at least equal to the fair market value of the stock on the date of grant. As of September 30, 2013, an aggregate of 10.0 million shares of common stock were authorized for issuance under the Plan, of which a total of approximately 2.1 million shares of common stock remained available for future awards. A single participant cannot be awarded more than 400,000 shares annually. Awards granted under the Plan have a contractual life of no more than 10 years. The terms and conditions of equity awards (such as price, vesting schedule, term and number of shares) under the Plan are specified in an award document, and approved by the Company’s compensation committee.

In June 2013 the Company’s stockholders approved the 2013 Employee Stock Purchase Plan (“ESPP”) which provides a means by which eligible employees of the Company and certain designated related corporations may be given an opportunity to purchase shares of Common Stock. As of September 30, 2013, there are 2.1 million shares of Common Stock reserved for purchase under the ESPP. The number of shares reserved for purchase under the ESPP increases on January 1 of each calendar year by the lesser of (i) 10% of the total number of shares of Common Stock outstanding on December 31st of the preceding year, or (ii) 200,000 shares of Common Stock. The ESPP allows employees to use up to 15% of their compensation to purchase shares of Common Stock at an amount equal to 85% of the fair market value of the Company’s Common Stock on the offering date or the purchase date, whichever is less.

The Company utilizes the Black-Scholes valuation model for estimating the fair value of all stock options granted where the vesting period is based on length of service or performance, while a Monte Carlo simulation model is used for estimating the fair value of stock options with market-based vesting conditions. Set forth below are the assumptions used in valuing the stock options granted and a discussion of the Company’s methodology for developing each of the assumptions used: 

     
For the nine months ended September 30,
   
 
 
 
2013
   
2012
   
                 
 
Risk-free interest rate
    0.02 - 1.92 %     0.71 - 1.49 %  
 
Expected dividend yield
        0 %         0 %  
 
Expected life (in years)
    5 - 7.3       5 - 6    
 
Expected volatility
    80.71 - 89.66 %     86.58 - 92.24 %  

“Risk-free interest rate” means the range of U.S. Treasury rates with a term that most closely resembles the expected life of the option as of the date the option is granted.
“Expected dividend yield” means the Company does not pay regular dividends on its common stock and does not anticipate paying any dividends in the foreseeable future.

“Expected life” means the period of time that options granted are expected to remain outstanding, based wholly on the use of the simplified (safe harbor) method. The simplified method is used because the Company does not yet have adequate historical exercise information to estimate the expected life the options granted.

“Expected volatility” means a measure of the amount by which a financial variable, such as share price, has fluctuated (historical volatility) or is expected to fluctuate (implied volatility) during a period. Expected volatility is based on the Company’s historical volatility and incorporates the volatility of the common stock of comparable companies when the expected life of the option exceeds the Company’s trading history.

Income Taxes

No income tax expense was recorded for the three and nine months ended September 30, 2013 and 2012, as the Company does not expect to have taxable income for 2013 and did not have taxable income in 2012. A full valuation allowance has been recorded against the Company’s deferred tax asset.

Earnings (Loss) per Share

Basic net income (loss) per share of common stock excludes dilution for potential common stock issuances and is computed by dividing net income (loss) by the weighted average number of shares outstanding for the period. Diluted net income (loss) per share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock. Diluted net loss per share is identical to basic net loss per share as potentially dilutive securities have been excluded from the calculation of diluted net loss per common share because the inclusion of such securities would be antidilutive.

The Company has excluded the following outstanding warrants and options from the calculation of diluted net loss per share because all such securities were antidilutive for the periods presented:

     
As of September 30,
   
 
Common Equivalent Securities
 
2013
   
2012
   
                 
 
Warrants
    10,534,245       6,065,495    
 
Options
    5,608,912       4,816,012    
                     
 
Total
    16,143,157       10,881,507    

Contingencies
From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of business.  The Company accrues for liabilities when it is probable that future expenditures will be made and such expenditures can be reasonably estimated.  For all periods presented, the Company is not a party to any pending material litigation or other material legal proceedings.

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Note 4 - Debt (Details) (USD $)
1 Months Ended 9 Months Ended
Sep. 30, 2013
Sep. 30, 2013
Note 4 - Debt (Details) [Line Items]    
Debt Instrument, Description of Variable Rate Basis   prime
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in Shares) 10,534,245 10,534,245
Class of Warrant or Right, Exercise Price of Warrants or Rights (in Dollars per Item) 2.70 2.70
Class of Warrant or Right, Exercise Price of Warrants or Rights (in Dollars per Share) 2.70 2.70
Interest Only Payments [Member] | Hercules Technology II, L.P. [Member]
   
Note 4 - Debt (Details) [Line Items]    
Debt Instrument, Frequency of Periodic Payment 12  
Panacela Loan [Member]
   
Note 4 - Debt (Details) [Line Items]    
Debt Instrument Assignment Percentage 69.20%  
Hercules Technology II, L.P. [Member] | Component 1 [Member]
   
Note 4 - Debt (Details) [Line Items]    
Debt Instrument, Basis Spread on Variable Rate   10.45%
Hercules Technology II, L.P. [Member] | Component 2 [Member]
   
Note 4 - Debt (Details) [Line Items]    
Debt Instrument, Basis Spread on Variable Rate 4.25%  
Hercules Technology II, L.P. [Member] | Principle And Interest Payments [Member]
   
Note 4 - Debt (Details) [Line Items]    
Debt Instrument, Frequency of Periodic Payment 27  
Hercules Technology II, L.P. [Member] | Option In Additional Borrowings [Member]
   
Note 4 - Debt (Details) [Line Items]    
Debt Instrument, Face Amount $ 4,000,000 $ 4,000,000
Hercules Technology II, L.P. [Member] | Warrant [Member]
   
Note 4 - Debt (Details) [Line Items]    
Debt Instrument, Unamortized Discount 117,999 117,999
Hercules Technology II, L.P. [Member] | Facility Fee [Member]
   
Note 4 - Debt (Details) [Line Items]    
Debt Instrument, Unamortized Discount 100,000 100,000
Hercules Technology II, L.P. [Member] | Payment [Member]
   
Note 4 - Debt (Details) [Line Items]    
Debt Instrument, Unamortized Discount 550,000 550,000
Hercules Technology II, L.P. [Member]
   
Note 4 - Debt (Details) [Line Items]    
Debt Instrument, Face Amount 6,000,000 6,000,000
Proceeds from Notes Payable 5,900,000  
Debt Instrument, Interest Rate, Stated Percentage Rate Range, Minimum   10.45%
Warrant Term 5 years  
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in Shares) 156,250 156,250
Class of Warrant or Right, Exercise Price of Warrants or Rights (in Dollars per Item) 1.60 1.60
Debt Issuance Cost 102,000  
Debt Instrument, Interest Rate, Effective Percentage 16.60% 16.60%
Class of Warrant or Right, Exercise Price of Warrants or Rights (in Dollars per Share) 1.60 1.60
Hercules Technology II, L.P. [Member] | Minimum [Member]
   
Note 4 - Debt (Details) [Line Items]    
Debt Instrument Penalty Rate 0.01  
Hercules Technology II, L.P. [Member] | Maximum [Member]
   
Note 4 - Debt (Details) [Line Items]    
Debt Instrument Penalty Rate 0.03  
Equity Private Placement 1,000,000 1,000,000
Panacela Loan [Member]
   
Note 4 - Debt (Details) [Line Items]    
Debt Instrument, Face Amount 1,530,000 1,530,000
Panacela Loan [Member]
   
Note 4 - Debt (Details) [Line Items]    
Class of Warrant or Right, Exercise Price of Warrants or Rights (in Dollars per Item) 1.694 1.694
Debt Instrument, Interest Rate, Stated Percentage 16.30% 16.30%
Debt Instrument, Convertible, Conversion Price (in Dollars per share) $ 1,057 $ 1,057
Debt Instrument, Convertible, Beneficial Conversion Feature $ 0.75  
Class of Warrant or Right, Exercise Price of Warrants or Rights (in Dollars per Share) 1.694 1.694
Minimum [Member]
   
Note 4 - Debt (Details) [Line Items]    
Class of Warrant or Right, Exercise Price of Warrants or Rights (in Dollars per Item) 1.60 1.60
Class of Warrant or Right, Exercise Price of Warrants or Rights (in Dollars per Share) 1.60 1.60
Maximum [Member]
   
Note 4 - Debt (Details) [Line Items]    
Class of Warrant or Right, Exercise Price of Warrants or Rights (in Dollars per Item) 5.00 5.00
Class of Warrant or Right, Exercise Price of Warrants or Rights (in Dollars per Share) 5.00 5.00
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Note 5 - Stockholders' Equity (Details) - Summary of option award activity under the Equity Incentive Plan: (USD $)
9 Months Ended
Sep. 29, 2013
Sep. 30, 2013
Sep. 30, 2012
Summary of option award activity under the Equity Incentive Plan: [Abstract]      
December 31, 2012 5,016,916 5,016,916  
December 31, 2012 (in Dollars per share) $ 4.54 $ 4.54  
December 31, 2012 404,500 404,500  
December 31, 2012 (in Dollars per share) $ 2.30 $ 2.30  
Granted 898,604 898,604 739,500
Granted (in Dollars per share) $ 1.67    
Granted (in Dollars per share) $ 1.21 $ 1.21 $ 1.53
Vested (506,875)    
Vested (in Dollars per share) $ 1.69    
Exercised (9,681)    
Exercised (in Dollars per share) $ 1.28    
Forfeited, Canceled (296,927)    
Forfeited, Canceled (in Dollars per share) $ 3.66    
Forfeited, Canceled (151,250)    
Forfeited, Canceled (in Dollars per share) $ 0.97    
September 30, 2013 5,608,912 220,833  
September 30, 2013 (in Dollars per share) $ 4.13    
September 30, 2013 644,979    
September 30, 2013 (in Dollars per share) $ 1.56    
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Consolidated Balance Sheets (current period unaudited) (Parentheticals) (USD $)
Sep. 30, 2013
Dec. 31, 2012
Preferred stock,par value (in Dollars per share) $ 0.005 $ 0.005
Preferred stock, shares authorized 10,000,000 10,000,000
Preferred stock, shares issued 0 0
Preferred stock, shares outstanding 0 0
Common stock, par value (in Dollars per share) $ 0.005 $ 0.005
Common stock, shares authorized 160,000,000 80,000,000
Common stock, shares issued 45,157,114 44,730,445
Common stock, outstanding 45,157,114 44,730,445
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Accounting Policies, by Policy (Policies)
9 Months Ended
Sep. 30, 2013
Accounting Policies [Abstract]  
Basis of Accounting, Policy [Policy Text Block]
Basis of Presentation and Consolidation

The accompanying consolidated financial statements include the accounts of CBLI and its subsidiaries, BioLab 612, Incuron and Panacela, collectively referred to herein as the “Company.” All significant intercompany balances and transactions have been eliminated in consolidation.

The unaudited consolidated financial statements included herein have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission ("SEC"). Certain information and footnote disclosures normally included in consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles have been condensed or omitted pursuant to such rules and regulations. These consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012, as amended, as filed with the SEC..

In the opinion of the Company’s management, any adjustments contained in the accompanying unaudited consolidated financial statements are of a normal recurring nature, and are necessary to present fairly the financial position of the Company as of September 30, 2013, along with its results of operations for the three and nine month periods ended September 30, 2013 and 2012 and cash flows for the nine month periods ended September 30, 2013 and 2012.  Interim results are not necessarily indicative of results that may be expected for any other interim period or for an entire year.
New Accounting Pronouncements, Policy [Policy Text Block]
Recent Accounting Pronouncements

In July 2013, the FASB issued ASU No. 2013-11, “Income Taxes (Topic 740): Presentation of an Unrecognized Tax Benefit When a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists (a consensus of the FASB Emerging Issues Task Force)” (“ASU 2013-11”). The amendments of ASU 2013-11 provide entities with guidance of how to present a provision for uncertain tax positions in the financial statements when a net operating loss carryforward, a similar tax loss, or a tax credit carryforward exists. For public entities, the amendments are effective for fiscal years and interim reporting periods beginning after December 15, 2013. The Company does not believe that the adoption of this standard will have a material impact on its consolidated financial statements.
Use of Estimates, Policy [Policy Text Block]
Use of Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, 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.  Actual results could differ from those estimates.
Cash and Cash Equivalents, Policy [Policy Text Block]
Cash and Cash Equivalents

Of the $14.3 million and $25.7 million of cash and cash equivalents at September 30, 2013 and December 31, 2012, respectively, $1.5 million and $13.0 million, respectively, consisted of highly liquid investments with maturities of 90 days or less when purchased.  These investments consist of commercial paper, short-term debt securities, time deposits and investments in money market funds with commercial banks and financial institutions. As of September 30, 2013, $3.5 million of the Company's cash and cash equivalents was restricted to the use of its majority-owned subsidiaries, leaving $10.8 million available for general use.
Marketable Securities, Policy [Policy Text Block]
Short-Term Investments

The Company’s short-term investments are classified as held to maturity given the intent and ability to hold the investments to maturity. Accordingly, these investments are carried at amortized cost. Short-term investments classified as held-to-maturity consisted of certificates of deposit with maturity dates beyond three months and less than one year. As of September 30, 2013, all of the Company’s short-term investments were restricted to use by its majority-owned subsidiaries.
Revenue Recognition, Policy [Policy Text Block]
Significant Customers and Accounts Receivable

Grant and contract revenue from the U.S. government accounted for 48.1% and 39.5% of total revenue for the three and nine months ended September 30, 2013, respectively, and 23.2% and 88.0% of total revenue for the three and nine months ended September 30, 2012, respectively.

Grant and contract revenue received by the Company’s subsidiaries from Russian government agencies accounted for 51.9% and 60.5% of total consolidated revenues for the three and nine months ended September 30, 2013, respectively, and 76.8% and 12.0% of total consolidated revenue for the three and nine months ended September 30, 2012, respectively.

Although the Company anticipates ongoing U.S. and Russian government contract and grant revenue, there is no guarantee that these revenue streams will continue in the future.

Accounts receivable consist of amounts due under reimbursement contracts with certain government and foreign entities. The Company extends unsecured credit to customers under normal trade agreements, which generally require payment within 30 days.

Management estimates an allowance for doubtful accounts that is based upon management's review of delinquent accounts and an assessment of the Company's historical evidence of collections. There were no allowances for doubtful accounts as of September 30, 2013 and December 31, 2012, as the collection history from the Company’s customers indicated that collection was probable.
Intangible Assets, Finite-Lived, Policy [Policy Text Block]
Intellectual Property

Costs related to filing and pursuing patent applications are recognized as general and administrative expenses (“G&A expenses”) as incurred, since the recoverability of such expenditures is uncertain. Upon marketing approval by the U.S. Food and Drug Administration (“FDA”) or a respective foreign governing body, such costs will be capitalized and depreciated over the expected life of the related patent.
Share-based Compensation, Option and Incentive Plans Policy [Policy Text Block]
Accounting for Stock-Based Compensation

The 2006 Equity Incentive Plan, as amended (the “Plan”), authorizes CBLI to grant (i) options to purchase common stock, (ii) restricted or unrestricted stock units, and (iii) stock appreciation rights, so long as the exercise or grant price of each are at least equal to the fair market value of the stock on the date of grant. As of September 30, 2013, an aggregate of 10.0 million shares of common stock were authorized for issuance under the Plan, of which a total of approximately 2.1 million shares of common stock remained available for future awards. A single participant cannot be awarded more than 400,000 shares annually. Awards granted under the Plan have a contractual life of no more than 10 years. The terms and conditions of equity awards (such as price, vesting schedule, term and number of shares) under the Plan are specified in an award document, and approved by the Company’s compensation committee.

In June 2013 the Company’s stockholders approved the 2013 Employee Stock Purchase Plan (“ESPP”) which provides a means by which eligible employees of the Company and certain designated related corporations may be given an opportunity to purchase shares of Common Stock. As of September 30, 2013, there are 2.1 million shares of Common Stock reserved for purchase under the ESPP. The number of shares reserved for purchase under the ESPP increases on January 1 of each calendar year by the lesser of (i) 10% of the total number of shares of Common Stock outstanding on December 31st of the preceding year, or (ii) 200,000 shares of Common Stock. The ESPP allows employees to use up to 15% of their compensation to purchase shares of Common Stock at an amount equal to 85% of the fair market value of the Company’s Common Stock on the offering date or the purchase date, whichever is less.

The Company utilizes the Black-Scholes valuation model for estimating the fair value of all stock options granted where the vesting period is based on length of service or performance, while a Monte Carlo simulation model is used for estimating the fair value of stock options with market-based vesting conditions. Set forth below are the assumptions used in valuing the stock options granted and a discussion of the Company’s methodology for developing each of the assumptions used: 

     
For the nine months ended September 30,
   
 
 
 
2013
   
2012
   
                 
 
Risk-free interest rate
    0.02 - 1.92 %     0.71 - 1.49 %  
 
Expected dividend yield
        0 %         0 %  
 
Expected life (in years)
    5 - 7.3       5 - 6    
 
Expected volatility
    80.71 - 89.66 %     86.58 - 92.24 %  

“Risk-free interest rate” means the range of U.S. Treasury rates with a term that most closely resembles the expected life of the option as of the date the option is granted.
“Expected dividend yield” means the Company does not pay regular dividends on its common stock and does not anticipate paying any dividends in the foreseeable future.

“Expected life” means the period of time that options granted are expected to remain outstanding, based wholly on the use of the simplified (safe harbor) method. The simplified method is used because the Company does not yet have adequate historical exercise information to estimate the expected life the options granted.

“Expected volatility” means a measure of the amount by which a financial variable, such as share price, has fluctuated (historical volatility) or is expected to fluctuate (implied volatility) during a period. Expected volatility is based on the Company’s historical volatility and incorporates the volatility of the common stock of comparable companies when the expected life of the option exceeds the Company’s trading history.
Income Tax, Policy [Policy Text Block]
Income Taxes

No income tax expense was recorded for the three and nine months ended September 30, 2013 and 2012, as the Company does not expect to have taxable income for 2013 and did not have taxable income in 2012. A full valuation allowance has been recorded against the Company’s deferred tax asset.
Earnings Per Share, Policy [Policy Text Block]
Earnings (Loss) per Share

Basic net income (loss) per share of common stock excludes dilution for potential common stock issuances and is computed by dividing net income (loss) by the weighted average number of shares outstanding for the period. Diluted net income (loss) per share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock. Diluted net loss per share is identical to basic net loss per share as potentially dilutive securities have been excluded from the calculation of diluted net loss per common share because the inclusion of such securities would be antidilutive.

The Company has excluded the following outstanding warrants and options from the calculation of diluted net loss per share because all such securities were antidilutive for the periods presented:
Commitments and Contingencies, Policy [Policy Text Block] Contingencies
From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of business.  The Company accrues for liabilities when it is probable that future expenditures will be made and such expenditures can be reasonably estimated.  For all periods presented, the Company is not a party to any pending material litigation or other material legal proceedings.
XML 36 R5.htm IDEA: XBRL DOCUMENT v2.4.0.8
Consolidated Statements of Comprehensive Loss (Unaudited) (USD $)
3 Months Ended 9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Sep. 30, 2013
Sep. 30, 2012
Net loss including noncontrolling interests $ (4,610,961) $ (12,315,676) $ (19,284,530) $ (24,621,440)
Other comprehensive income (loss)        
Foreign currency translation adjustment 35,821 593,124 (404,248) 658,888
Comprehensive loss including noncontrolling interests (4,575,140) (11,722,552) (19,688,778) (23,962,552)
Comprehensive loss attributable to noncontrolling interests 502,891 1,182,641 2,552,089 2,997,934
Comprehensive loss attributable to Cleveland BioLabs, Inc. $ (4,072,249) $ (10,539,911) $ (17,136,689) $ (20,964,618)
XML 37 R2.htm IDEA: XBRL DOCUMENT v2.4.0.8
Consolidated Balance Sheets (current period unaudited) (USD $)
Sep. 30, 2013
Dec. 31, 2012
Current assets:    
Cash and cash equivalents $ 14,312,921 $ 25,652,083
Short-term investments 309,166 2,633,944
Accounts receivable 603,494 41,896
Other current assets 590,714 1,078,040
Total current assets 15,816,295 29,405,963
Equipment, net 825,746 986,553
Restricted cash 2,871,553 1,577,920
Other long-term assets 174,822 39,597
Total assets 19,688,416 32,010,033
Current liabilities:    
Accounts payable 1,202,198 1,523,875
Accrued expenses 3,082,585 2,410,592
Deferred revenue 2,035,120 3,314,918
Accrued warrant liability 3,594,741 4,105,659
Current portion of capital lease obligation 80,709 71,679
Total current liabilities 9,995,353 11,426,723
Noncurrent portion of capital lease obligation 29,560 97,602
Long-term debt 7,330,449  
Total liabilities 17,355,362 11,524,325
Stockholders' equity:    
Preferred stock, $.005 par value; 10,000,000 shares authorized, 0 shares issued and outstanding as of September 30, 2013 and December 31, 2012, respectively      
Common stock, $.005 par value; 160,000,000 shares authorized, 45,157,114 shares issued and outstanding as of September 30, 2013; 80,000,000 shares authorized, 44,730,445 issued and outstanding as of December 31, 2012 225,786 223,653
Additional paid-in capital 125,398,821 123,864,830
Accumulated other comprehensive income 307,414 546,473
Accumulated deficit (135,199,419) (118,301,789)
Total Cleveland BioLabs, Inc. stockholders' (deficit) equity (9,267,398) 6,333,167
Noncontrolling interest in stockholders' equity 11,600,452 14,152,541
Total stockholders' equity 2,333,054 20,485,708
Total liabilities and stockholders' equity $ 19,688,416 $ 32,010,033
XML 38 R29.htm IDEA: XBRL DOCUMENT v2.4.0.8
Note 4 - Debt (Details) - Warrant fair value assumptions
9 Months Ended
Sep. 30, 2013
Warrant fair value assumptions [Abstract]  
Risk-free interest rate 0.48%
Expected dividend yield 0.00%
Expected life (years) 2 years 6 months
Expected volatility 82.29%
XML 39 R23.htm IDEA: XBRL DOCUMENT v2.4.0.8
Note 3 - Fair Value of Financial Instruments (Details) - Fair value hierarchy for its financial liabilities: (USD $)
Sep. 30, 2013
Dec. 31, 2012
Note 3 - Fair Value of Financial Instruments (Details) - Fair value hierarchy for its financial liabilities: [Line Items]    
Compensatory stock options not yet issued (1) $ 166,783 [1]  
Accrued warrant liability 3,594,741 4,105,659
Total liabilities 3,761,524 4,105,659
Fair Value, Inputs, Level 1 [Member]
   
Note 3 - Fair Value of Financial Instruments (Details) - Fair value hierarchy for its financial liabilities: [Line Items]    
Compensatory stock options not yet issued (1)    [1]  
Fair Value, Inputs, Level 2 [Member]
   
Note 3 - Fair Value of Financial Instruments (Details) - Fair value hierarchy for its financial liabilities: [Line Items]    
Compensatory stock options not yet issued (1)    [1]  
Fair Value, Inputs, Level 3 [Member]
   
Note 3 - Fair Value of Financial Instruments (Details) - Fair value hierarchy for its financial liabilities: [Line Items]    
Compensatory stock options not yet issued (1) 166,783 [1]  
Accrued warrant liability 3,594,741 4,105,659
Total liabilities $ 3,761,524 $ 4,105,659
[1] Included in accrued expenses in the accompanying consolidated balance sheets.
XML 40 R13.htm IDEA: XBRL DOCUMENT v2.4.0.8
Note 6 - Warrants
9 Months Ended
Sep. 30, 2013
Derivative Instruments and Hedging Activities Disclosure [Abstract]  
Derivative Instruments and Hedging Activities Disclosure [Text Block]
6. Warrants

In connection with sales of the Company’s common stock and the issuance of debt instruments, warrants were issued with exercise prices ranging from $1.60 to $5.00.  The warrants expire between one and seven years from the date of grant, subject to the terms applicable in the agreement.  As of September 30, 2013, the Company had warrants outstanding that are exercisable into 10,534,245 shares of common stock, with a weighted average exercise price of $2.70 per share. The Rusnano Warrant (as described in more detail in Note 4) is not included in the 10,534,245 shares of common stock as Panacela is not in default under the Panacela Loan.

During the three months ended September 30, 2013, CBLI issued warrants to Rusnano and Hercules in connection with the respective loan agreements. The Panacela Loan triggered a reduction in the exercise price of the Company’s warrants issued in March 2010 from $2.00 per share to $1.694 per share. The March 2010 warrant exercise price was further reduced to $1.60 per share in connection with the closing of the Hercules Loan.

XML 41 R30.htm IDEA: XBRL DOCUMENT v2.4.0.8
Note 4 - Debt (Details) - Summary of principal payments (USD $)
Sep. 30, 2013
Note 4 - Debt (Details) - Summary of principal payments [Line Items]  
2014 $ 351,527
2015 2,246,215
2016 2,495,163
2017 1,457,095
Total 7,330,449
Long Term Debt Excluding Discounts [Member]
 
Note 4 - Debt (Details) - Summary of principal payments [Line Items]  
Total $ 6,550,000
XML 42 R16.htm IDEA: XBRL DOCUMENT v2.4.0.8
Note 3 - Fair Value of Financial Instruments (Tables)
9 Months Ended
Sep. 30, 2013
Fair Value Disclosures [Abstract]  
Fair Value, Liabilities Measured on Recurring Basis [Table Text Block]
   
As of September 30, 2013
 
   
Level 1
   
Level 2
   
Level 3
   
Total
 
Liabilities:
                       
Compensatory stock options not yet issued (1)
  $ -     $ -     $ 166,783     $ 166,783  
Accrued warrant liability
    -       -       3,594,741       3,594,741  
                                 
Total liabilities
  $ -     $ -     $ 3,761,524     $ 3,761,524  
   
As of December 31, 2012
 
   
Level 1
   
Level 2
   
Level 3
   
Total
 
Liabilities:
                       
Accrued warrant liability
  $ -     $ -     $ 4,105,659     $ 4,105,659  
                                 
Total liabilities
  $ -     $ -     $ 4,105,659     $ 4,105,659  
Schedule of Share-based Payment Award, Warrant Liability, Valuation Assumptions [Table Text Block]
   
September 30, 2013
   
December 31, 2012
 
             
Stock Price
  $     1.57     $     1.33  
Exercise Price
  $ 1.60 - 5.00     $ 1.60 - 5.00  
Term in years
    0.71 - 2.03       1.09 - 2.41  
Volatility
    48.41 - 79.57 %     82.75 - 95.91 %
Annual rate of quarterly dividends
        0 %         0 %
Discount rate- bond equivalent yield
    .07 - .34 %     .17 - .29 %
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block]
     
September 30, 2013
   
           
 
Stock price
  $ 1.57    
 
Term in years
    5    
 
Volatility
    79.93 %  
 
Annual rate of quarterly dividends
    0 %  
 
Discount rate - bond equivalent yield
    1.40 %  
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block]
   
Three months ended September 30, 2013
   
Nine months ended September 30, 2013
 
   
Accrued Warrant
Liability
      Compensatory
Stock Options
Not Yet Issued
    Accrued Warrant
Liability
   
Compensatory
Stock Options
Not Yet Issued
 
                         
Beginning balance
  $ 4,757,770     $ 63,838     $ 4,105,659     $ -  
Total (gains) or losses, realized and unrealized, included in earnings (1)(2)
    (1,163,029 )     -       (510,918 )     -  
Estimates and other changes in fair value
    -       102,945       -       166,783  
Settlements
    -       -       -       -  
                                 
Balance, September 30, 2013
  $ 3,594,741     $ 166,783     $ 3,594,741     $ 166,783  
   
Three months ended September 30, 2012
   
Nine months ended September 30, 2012
 
     
Accrued Warrant
Liability
      Compensatory
Stock Options
Not Yet Issued
     
Accrued Warrant
Liability
   
Compensatory
Stock Options
Not Yet Issued
 
                         
Beginning balance
  $ 3,022,933     $ 114,617     $ 7,285,959     $ 378,750  
Total (gains) or losses, realized and unrealized, included in earnings (1)(2)
    4,423,775       -       160,749       51,823  
Estimates and other changes in fair value
    -       169,708       -       284,325  
Settlements
    -       -       -       (430,573 )
                                 
Balance, September 30, 2012
  $ 7,446,708     $ 284,325     $ 7,446,708     $ 284,325  
Fair Value, Assets and Liabilities Measured on Nonrecurring Basis, Valuation Techniques [Table Text Block]
   
September 30, 2013
 
Description
 
Fair Value
   
Valuation Technique
 
Unobservable Input
 
Range
 
                     
Compensatory stock options not yet issued
  $ 166,783    
Black-scholes pricing model
 
Expected term
    5  
               
Quantity of options
    220,833  
                         
Accrued warrant liability
    3,594,741    
Black-scholes pricing model
 
Expected term
    0.71   -   2.03  
                         
    $ 3,761,524                  
XML 43 R12.htm IDEA: XBRL DOCUMENT v2.4.0.8
Note 5 - Stockholders' Equity
9 Months Ended
Sep. 30, 2013
Stockholders' Equity Note [Abstract]  
Stockholders' Equity Note Disclosure [Text Block]
5. Stockholders’ Equity

The Company has granted options to purchase shares of common stock and shares of restricted stock. The following is a summary of option award activity during the nine months ended September 30, 2013:

   
Nine months ended September 30, 2013
 
   
Total Stock
Options
Outstanding
   
Weighted Average
Exercise Price per
Share
   
Nonvested Stock
Options
   
Weighted Average
Grant Date Fair
Value per Share
 
                         
December 31, 2012
    5,016,916     $ 4.54       404,500     $ 2.30  
Granted
    898,604       1.67       898,604       1.21  
Vested
    -       -       (506,875 )     1.69  
Exercised
    (9,681 )     1.28       -       -  
Forfeited, Canceled
    (296,927 )     3.66       (151,250 )     0.97  
                                 
September 30, 2013
    5,608,912     $ 4.13       644,979     $ 1.56  

The following is a summary of outstanding stock options as of September 30, 2013:

   
As of September 30, 2013
 
   
Stock Options
Outstanding
   
Vested Stock
 Options
 
             
Quantity
    5,608,912       4,963,933  
Weighted-average exercise price
  $ 4.13     $ 4.39  
Weighted Average Remaining Contractual Term (in Years)
    7.01       6.72  
Intrinsic value
  $ 134,340     $ 122,487  

For the nine months ended September 30, 2013 and 2012, the Company granted 898,604 and 739,500 stock options, respectively, with a weighted-average grant date fair value of $1.21 and $1.53, respectively. For the nine months ended September 30, 2013 and 2012, the total fair value of options vested was $858,037 and $1,246,720, respectively. The total intrinsic value of options exercised for the nine months ended September 30, 2013 and 2012 was $5,736 and $1,500, respectively.

As of September 30, 2013, total compensation cost not yet recognized related to nonvested stock options was $606,070.  The Company expects to recognize this cost over a weighted average period of approximately 0.85 years.

XML 44 R7.htm IDEA: XBRL DOCUMENT v2.4.0.8
Consolidated Statements of Cash Flows (Unaudited) (USD $)
9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Cash flows from operating activities:    
Net loss $ (19,284,530) $ (24,621,440)
Adjustments to reconcile net income (loss) to net cash used in operating activities:    
Depreciation 284,278 376,814
Unrealized loss on short-term investments   138,910
Noncash compensation 1,591,986 2,272,020
Change in value of warrant liability (510,919) 160,749
Changes in operating assets and liabilities:    
Accounts receivable (565,336) 1,695,870
Other current assets 452,798 (435,305)
Other long-term assets (3,995) (2,554)
Accounts payable (310,150) (471,635)
Deferred revenue (1,102,472) 3,821,991
Accrued interest 18,448  
Accrued expenses 506,750 1,609,369
Net cash used in operating activities (18,923,142) (15,455,211)
Cash flows from investing activities:    
Purchase of short-term investments   (4,898,314)
Sale of short-term investments 2,213,999 3,560,812
Purchase of equipment (125,218) (154,742)
Increase in restricted cash (1,421,861)  
Net cash provided by (used in) investing activities 666,920 (1,492,244)
Cash flows from financing activities:    
Noncontrolling interest capital contribution to Incuron, LLC   5,893,557
Net proceeds from issuance of debt 7,297,675  
Exercise of options 12,392 1,425
Repayment of capital lease obligation (59,012) (36,029)
Net cash provided by financing activities 7,251,055 5,858,953
Effect of exchange rate change on cash and equivalents (333,995) 404,486
Decrease in cash and cash equivalents (11,339,162) (10,684,016)
Cash and cash equivalents at beginning of period 25,652,083 22,872,589
Cash and cash equivalents at end of period 14,312,921 12,188,573
Supplemental disclosure of cash flow information:    
Cash paid during the period for interest 17,105 17,253
Supplemental schedule of noncash financing activities:    
Fair value of warrants issued in connection with debt 117,999  
Equipment acquired through lease financing   $ 221,690
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Note 5 - Stockholders' Equity (Details) - Summary of outstanding stock options under the Plan: (USD $)
9 Months Ended
Sep. 30, 2013
Sep. 29, 2013
Dec. 31, 2012
Sep. 30, 2013
Employee Stock Option [Member]
Note 5 - Stockholders' Equity (Details) - Summary of outstanding stock options under the Plan: [Line Items]        
Quantity 220,833 5,608,912 5,016,916 5,608,912
Quantity       4,963,933
Weighted-average exercise price (in Dollars per share)   $ 4.13 $ 4.54 $ 4.13
Weighted-average exercise price (in Dollars per share)       $ 4.39
Weighted Average Remaining Contractual Term (in Years)       7 years 3 days
Weighted Average Remaining Contractual Term (in Years)       6 years 262 days
Intrinsic value (in Dollars)       $ 134,340
Intrinsic value (in Dollars)       $ 122,487
XML 47 R19.htm IDEA: XBRL DOCUMENT v2.4.0.8
Note 1 - Description of Business (Details)
Sep. 30, 2013
Note 1 - Description of Business (Details) [Line Items]  
Number of Majority Owned Subsidiaries 2
BioLab 612 [Member]
 
Note 1 - Description of Business (Details) [Line Items]  
Number Of Wholly-Owned Subsidiaries 1
XML 48 R15.htm IDEA: XBRL DOCUMENT v2.4.0.8
Note 2 - Summary of Significant Accounting Policies (Tables)
9 Months Ended
Sep. 30, 2013
Accounting Policies [Abstract]  
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Method Used
     
For the nine months ended September 30,
   
 
 
 
2013
   
2012
   
                 
 
Risk-free interest rate
    0.02 - 1.92 %     0.71 - 1.49 %  
 
Expected dividend yield
        0 %         0 %  
 
Expected life (in years)
    5 - 7.3       5 - 6    
 
Expected volatility
    80.71 - 89.66 %     86.58 - 92.24 %  
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block]
     
As of September 30,
   
 
Common Equivalent Securities
 
2013
   
2012
   
                 
 
Warrants
    10,534,245       6,065,495    
 
Options
    5,608,912       4,816,012    
                     
 
Total
    16,143,157       10,881,507    
XML 49 R22.htm IDEA: XBRL DOCUMENT v2.4.0.8
Note 2 - Summary of Significant Accounting Policies (Details) - The Company has excluded the following outstanding warrants and options from the calculation of diluted earnings per share
9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Note 2 - Summary of Significant Accounting Policies (Details) - The Company has excluded the following outstanding warrants and options from the calculation of diluted earnings per share [Line Items]    
Antidilutive Securities 16,143,157 10,881,507
Warrant [Member]
   
Note 2 - Summary of Significant Accounting Policies (Details) - The Company has excluded the following outstanding warrants and options from the calculation of diluted earnings per share [Line Items]    
Antidilutive Securities 10,534,245 6,065,495
Employee Stock Option [Member]
   
Note 2 - Summary of Significant Accounting Policies (Details) - The Company has excluded the following outstanding warrants and options from the calculation of diluted earnings per share [Line Items]    
Antidilutive Securities 5,608,912 4,816,012
XML 50 R20.htm IDEA: XBRL DOCUMENT v2.4.0.8
Note 2 - Summary of Significant Accounting Policies (Details) (USD $)
9 Months Ended 9 Months Ended 3 Months Ended 9 Months Ended 3 Months Ended 9 Months Ended 9 Months Ended
Sep. 30, 2013
Dec. 31, 2012
Sep. 30, 2012
Dec. 31, 2011
Sep. 30, 2013
2013 ESPP Plan [Member]
Sep. 30, 2012
2013 ESPP Plan [Member]
Sep. 30, 2013
Grant and Contract Revenue From USA [Member]
Sep. 30, 2012
Grant and Contract Revenue From USA [Member]
Sep. 30, 2013
Grant and Contract Revenue From USA [Member]
Sep. 30, 2012
Grant and Contract Revenue From USA [Member]
Sep. 30, 2013
Grant And Contract Revenue From Outside United States [Member]
Sep. 30, 2012
Grant And Contract Revenue From Outside United States [Member]
Sep. 30, 2013
Grant And Contract Revenue From Outside United States [Member]
Sep. 30, 2012
Grant And Contract Revenue From Outside United States [Member]
Sep. 30, 2013
Accounts Receivable [Member]
Sep. 30, 2013
Majority Owned Subsidiaries [Member]
Sep. 30, 2013
General Use [Member]
Sep. 30, 2013
Certificates of Deposit [Member]
Beyond [Member]
Sep. 30, 2013
Certificates of Deposit [Member]
Less Than [Member]
Note 2 - Summary of Significant Accounting Policies (Details) [Line Items]                                      
Cash and Cash Equivalents, at Carrying Value (in Dollars) $ 14,312,921 $ 25,652,083 $ 12,188,573 $ 22,872,589                              
Other Cash Equivalents, at Carrying Value (in Dollars) 1,500,000 13,000,000                                  
Cash and Highly Liquid Investments Maturity 90 days                                    
Subsidiary Cash Total (in Dollars)                               3,500,000      
General Use Cash Total (in Dollars)                                 $ 10,800,000    
Short-Term Investments Maturity                                   3 months 1 year
Concentration Risk, Percentage             48.10% 23.20% 39.50% 88.00% 51.90% 76.80% 60.50% 12.00%          
Credit Term                             30 days        
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in Shares) 10,000,000                                    
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in Shares) 2,100,000         2,100,000                          
Share-based Compensation Arrangement by Share-based Payment Award, Maximum Number of Shares Per Employee (in Shares) 400,000                                    
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period 10 years                                    
Percentage Of The Total Number Of Shares Of Common Stock Outstanding Of The Preceding Year         10.00%                            
Share-Based Compensation Arrangement By Share-Based Payment Award Number Of Shares Limited Per Year (in Shares)         200,000                            
Share-based Compensation Arrangement by Share-based Payment Award, Maximum Employee Subscription Rate         15.00%                            
Share-based Compensation Arrangement by Share-based Payment Award, Discount from Market Price, Offering Date         85.00%                            
XML 51 R1.htm IDEA: XBRL DOCUMENT v2.4.0.8
Document And Entity Information
9 Months Ended
Sep. 30, 2013
Nov. 05, 2013
Document and Entity Information [Abstract]    
Entity Registrant Name CLEVELAND BIOLABS INC  
Document Type 10-Q  
Current Fiscal Year End Date --12-31  
Entity Common Stock, Shares Outstanding   45,182,114
Amendment Flag false  
Entity Central Index Key 0001318641  
Entity Current Reporting Status Yes  
Entity Voluntary Filers No  
Entity Filer Category Accelerated Filer  
Entity Well-known Seasoned Issuer No  
Document Period End Date Sep. 30, 2013  
Document Fiscal Year Focus 2013  
Document Fiscal Period Focus Q3  
XML 52 R21.htm IDEA: XBRL DOCUMENT v2.4.0.8
Note 2 - Summary of Significant Accounting Policies (Details) - Assumptions used in valuing the stock options granted:
9 Months Ended 12 Months Ended 9 Months Ended 12 Months Ended
Sep. 30, 2013
Sep. 30, 2013
Employee Stock Option [Member]
Minimum [Member]
Sep. 30, 2012
Employee Stock Option [Member]
Minimum [Member]
Sep. 30, 2013
Employee Stock Option [Member]
Maximum [Member]
Sep. 30, 2012
Employee Stock Option [Member]
Maximum [Member]
Sep. 30, 2013
Minimum [Member]
Dec. 31, 2012
Minimum [Member]
Sep. 30, 2013
Maximum [Member]
Dec. 31, 2012
Maximum [Member]
Note 2 - Summary of Significant Accounting Policies (Details) - Assumptions used in valuing the stock options granted: [Line Items]                  
Risk-free interest rate 1.40% 0.02% 0.71% 1.92% 1.49% 0.07% 0.17% 0.34% 0.29%
Expected dividend yield 0.00%     0.00% 0.00%     0.00% 0.00%
Expected life (in years) 5 years 5 years 5 years 7 years 109 days 6 years 259 days 1 year 32 days 2 years 10 days 2 years 149 days
Expected volatility 79.93% 80.71% 86.58% 89.66% 92.24% 48.41% 82.75% 79.57% 95.91%