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

 
FORM 10 - Q
 

 
x
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended December 31, 2009
 
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: 333-148471
 
NANOVIRICIDES, INC.
(Exact name of registrant as specified in its charter)

NEVADA
76-0674577
(State or other jurisdiction of incorporation or organization)
(IRS Employer Identification No.)

135 Wood Street, Suite 205
West Haven, Connecticut 06516
(Address of principal executive offices and zip code)
(203) 937-6137
( Registrant’s telephone number, including area code)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act 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              No 

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

Indicate by check mark whether the registrant is a larger accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of "accelerated filer and large accelerated filer" in Rule 12b-2 of the Exchange Act. (Check one)

Large accelerated filer             ¨
Accelerated filer ¨
Non-accelerated filer               ¨
Smaller reporting company Q

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

The number of shares outstanding of the Registrant's Common Stock as of February 19, 2010 was: 131,910,584.
 


 
 

 

Na noViricides, Inc.
FORM 10-Q
INDEX


PART I FINANCIAL INFORMATION
Page
       
Item 1.
 
Financial Statements
 
       
3
       
4
       
5
       
7
       
Item 2.
  15
       
Item 3.
  26
       
Item 4.
  26
       
PART II OTHER INFORMATION
 
       
Item 1.
  26
       
Item 2.
  27
       
Item 3.
  27
       
Item 4.
  27
       
Item 5.
  27
       
Item 6.
  28
       
30
       
Certifications
 
 

NA NOVIRICIDES, INC.
(A DEVELOPMENT STAGE COMPANY)
BALANCE SHEETS
(Unaudited)
   
December 31, 2009
  June 30, 2009  
   
(Unaudited)
   
ASSETS
   
 
 
 
   
 
 
CURRENT ASSETS:
     
 
 
Cash and cash equivalents
  $ 4,032,863     $ 1,689,442  
Prepaid expenses
    312,904       321,545  
Other current assets
    107,026        109,312  
                 
Total current assets
    4,452,793       2,120,299  
 
           
Property and equipment, net
    833,809       688,618  
                 
OTHER ASSETS:
               
Trademark, net
    322,914       192,344  
                 
Total other assets
    322,914       192,344  
                 
  TOTAL ASSETS
  $ 5,609,516     $ 3,001,261  
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
 
       
 
 
CURRENT LIABILITIES:
               
Accounts payable
  $ 217,878     $ 147,067  
Accounts payable – related parties
    957,213       300,969  
Accrued expenses
    31,066       35,087  
Accrued payroll  to officers and related payroll  tax expense
    54,832       32,596  
                 
TOTAL CURRENT LIABILITIES
    1,260,989       515,719  
                 
                 
COMMITMENTS AND CONTINGENCIES
               
 
       
 
 
STOCKHOLDERS’ EQUITY
               
Common stock, $0.001 par value; 300,000,000 shares authorized; 131,910,584 and 125,299,457 shares issued and outstanding.  
    131,911       125,299  
Additional paid-in capital
    17,868,788       14,455,778  
Stock subscription receivable
    -       (100,000 )
Deficit accumulated during the development stage
    (13,652,172 )     (11,995,535 )
                 
TOTAL STOCKHOLDERS’ EQUITY
    4,348,527       2,485,542  
                 
  TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
  $ 5,609,516     $ 3,001,261  


See accompanying notes to financial statements .


NA NOVIRICIDES, INC.
 (A DEVELOPMENT STAGE COMPANY)
STATEMENTS OF OPERATIONS
(UNAUDITED)
   
Three Months Ended
   
Six Months Ended
   
For the Period from May 12, 2005 (Inception) through
 
   
December 31
   
December 31,
   
December 31,
 
   
2009
   
2008
   
2009
   
2008
   
2009
 
Revenues
  $ -     $ -     $ -     $ -        
                                       
Operating expenses:
                                     
Research and development
    629,803       426,957       1,093,725       927,242       7,815,688  
Refund credit research and development costs
    -       -       -       -       (258,318 )
General and administrative
    296,765       217,547       564,902       474,094       5,457,789  
Total operating expenses
    926,568       644,504       1,658,627       1,401,336       13,015,159  
Loss from operations
    (926,568 )     (644,504 )     (1,658,627 )     (1,401,336 )     (13,015,159 )
                                         
Other income (expense):
                                       
Interest income
    1,120       14,004       1,990       26,081       149,996  
Non cash interest on convertible debentures
    -       -               -       (73,930 )
Non cash interest expense on beneficial conversion feature of convertible  debentures
    -       -       -       -       (713,079 )
Total other income (expense)
    1,120       14,004       1,990       26,081       (637,013 )
                                         
Net loss
    (925,448 )   $ (630,500 )     (1,656,637 )   $ (1,375,255 )     (13,652,172 )
                                         
Net loss per common share: basic and diluted
  $ (0.007 )   $ (0.01 )   $ (0.01 )   $ (0.01 )        
                                         
Weighted average common shares outstanding: basic and diluted
    127,546,405       122,716,140       126,669,572       121,660,720          

 
See accompanying notes to financial statements .


NA NOVIRICIDES, INC.
(A DEVELOPMENT STAGE COMPANY)
STATEMENTS OF CASH FLOWS
(UNAUDITED)
 
    Six Months Ended     For the Period from May 12, 2005 (Inception) through  
   
December 31,
    December 31,  
    2009    
2008
   
 2009
 
CASH FLOWS FROM OPERATING ACTIVITIES:
                 
Net loss
    (1,656,637 )   $ (1,375,255 )     (13,652,172 )
Adjustments to reconcile net loss to net cash used in operating activities:
                       
Shares and warrants issued for services rendered
    99,832       58,000       910,389  
Warrants granted to scientific advisory board
    81,000       78,000       525,841  
Options issued to officers as compensation
    -       -       121,424  
Depreciation and amortization
    7,731       4,615       29,068  
Amortization of deferred financing expenses
    -       -       51,175  
Non cash interest on convertible debentures
    -       -       73,930  
Non cash interest expense on beneficial conversion feature of convertible debentures
    -       -       713,079  
Changes in operating assets and liabilities:
                       
Prepaid expenses
    8,641       59,567       (312,904 )
Deferred expenses
    -       -       (2,175 )
Other  current assets
    2,286       (24,791 )     (107,026 )
Accounts payable
    70,811       (172,913 )     505,378  
Accounts payable – related parties
    656,244       188,111       957,213  
Accrued expenses
    (4,021 )     (72,645 )     31,066  
Accrued payroll to officers and related payroll tax expense
    22,236       (258,432 )     54,832  
Net cash used in operating activities
    (711,877 )     (1,515,743 )     (10,100,882 )
                         
CASH FLOWS FROM INVESTING ACTIVITIES:
                       
Security deposit
    -       24,000       -  
Purchases of property and equipment
    (148,534 )     (498,382 )     (851,668 )
Trademark and patent costs
    (134,958 )     (118,073 )     (334,123 )
Net cash used in investing activities
    (283,492 )     (592,455 )     (1,185,791 )
                         
CASH FLOWS FROM FINANCING ACTIVITIES:
                       
Proceeds from issuance of convertible debentures
    -       -       1,000,000  
Proceeds from issuance of common stock and warrants in   connection with private placements of common stock – net of fees
    1,437,450       3,227,554       11,301,926  
Proceeds from exercise of stock warrants attached to convertible debentures
    1,901,340       -       2,927,590  
Stock subscription received
    -       -       20  
Proceeds from exercise of stock options
    -       -       90,000  
Net cash provided by financing activities
    3,338,790       3,227,554       15,319,536  
NET INCREASE IN CASH AND CASH EQUIVALENTS
    2,343,421       1,119,356       4,032,863  
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD
    1,689,442       816,386       -  
CASH AND CASH EQUIVALENTS, END OF PERIOD
  $ 4,032,863     $ 1,935,742     $ 4,032,863  


See accompanying notes to financial statements.


NANOVIRICIDES, INC.
 (A DEVELOPMENT STAGE COMPANY)
STATEMENTS OF CASH FLOWS (CONTINUED)
SUPPLEMENTAL DISCLOSURE OF NON-CASH ACTIVITY
(UNAUDITED)
During the periods indicated below, the Company had the following non-cash activity:

   
 
   
For the Period from May 12,
2005 (Inception) through
December 31, 2009
 
   
Six Months Ended
December 31,
     
   
2009
   
2008
     
                   
Common stock issued for services rendered
    99,832     $ 58,000       157,832  
                         
Stock options issued to the officers as compensation
    -       -       121,424  
                         
Stock warrants granted to scientific advisory board
    81,000       78,000       159,000  
                         
Stock warrants granted to brokers
    3,563       9,849       13,412  
                         
Common stock issued for interest on debentures
    -       -       73,930  
                         
Shares of common stock issued in connection with debenture offering
    -       -       49,000  
                         
Common stock issued upon conversion of convertible debentures
    -       -       1,000,000  
                         
Debt discount related to beneficial conversion feature of convertible debt
    -       -       713,079  
                         
Warrants issued in connection with private placement
    5,097,300       827,485       7,681,578  
                         
Common Stock issued for equipment
    -       -       137,500  
                         
Common Stock issued upon conversion of  accounts payable
    25,200       150,000       175,200  


See accompanying notes to financial statements.


NA NOVIRICIDES, INC
(A DEVELOPMENT STAGE COMPANY)
FOR THE PERIOD FROM MAY 12, 2005 (INCEPTION) TO DECEMBER 31, 2009
NOTES TO FINANCIAL STATEMENTS
(Unaudited)

 

 
Note 1. Organization and Nature of Business

NanoViricides, Inc. was incorporated under the laws of the State of Colorado on July 25, 2000 as Edot-com.com, Inc., and was organized for the purpose of conducting internet retail sales.  On April 1, 2005, Edot-com.com, Inc . was incorporated under the laws of the State of Nevada for the purpose of re-domiciling the Company as a Nevada corporation.  On May 12, 2005, the Corporations were merged and Edot-com.com, Inc., a Nevada corporation, , became the surviving entity.

On June 1, 2005, Edot-com.com, Inc. (“ECMM”) acquired NanoViricide, Inc., a privately owned Florida corporation (“NVI”), pursuant to an Agreement and Plan of Share Exchange (the “Exchange”).  NanoViricides, Inc. was incorporated under the laws of the State of Florida on May 12, 2005.

Pursuant to the terms of the Exchange, ECMM acquired NVI in exchange for an aggregate of 80,000,000 newly issued shares of ECMM common stock resulting in an aggregate of 100,000,000 shares of ECMM common stock issued and outstanding representing 80% of the voting capital stock of ECMM immediately after the Exchange transaction.  NVI then became a wholly-owned subsidiary of ECMM. The ECMM shares were issued to the NVI Shareholders on a pro rata basis, on the basis of 4,000 shares of ECMM’s Common Stock for each share of NVI common stock held by such NVI Shareholder at the time of the Exchange.

As a result of the ownership interests of the former shareholders of NVI for financial accounting purposes, the merger between ECMM and NVI has been treated as a reverse acquisition with NVI deemed the accounting acquirer and ECMM deemed the accounting acquiree under the purchase method of accounting in accordance with Statement of Financial Accounting Standards No. 141 “ Business Combinations” (“SFAS No. 141”).  The reverse merger is deemed a capital transaction and the net assets of NVI (the accounting acquirer) are carried forward to ECMM (the legal acquirer and the reporting entity) at their carrying value before the combination.  The acquisition process utilizes the capital structure of ECMM and the assets and liabilities of NVI which are recorded at historical cost. The equity of ECMM is the historical equity of NVI retroactively restated to reflect the number of shares issued by ECMM in the transaction. Accordingly, the financial statements have been prepared to give retroactive effect to May 12, 2005 (date of inception), of the reverse acquisition completed on June 1, 2005, and represent the operations of NVI.

On June 28, 2005, NVI was merged into its parent ECMM and the separate corporate existence of NVI ceased.  Effective on the same date, ECMM changed its name to NanoViricides, Inc. and its stock symbol to “NNVC”, respectively.   NanoViricides, Inc. is considered a development stage company at this time.

NanoViricides, Inc. (the “Company”), is a nano-biopharmaceutical company whose business goals are to discover, develop and commercialize therapeutics to advance the care of patients suffering from life-threatening viral infections. We are a development stage company with several drugs in various stages of early development. The Company’s drugs are based on several patents, patent applications, provisional patent applications, and other proprietary intellectual property held by TheraCour Pharma, Inc. (“TheraCour®”), to which the Company has licenses in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Influenza including Asian Bird Flu Virus, Herpes Simplex Virus (HSV), Hepatitis C Virus (HCV),Hepatitis B Virus (HBV), and Rabies. The Company has entered into an Additional License Agreement  with TheraCour granting the Company the exclusive licenses in perpetuity for technologies developed by TheraCour for the additional virus types for Dengue viruses, Japanese Encephalitis, West Nile Virus,  viruses causing viral Conjunctivitis (a disease of the eye) and Ocular Herpes, and Ebola/Marburg viruses,.


The Company focuses its research and clinical programs on specific anti-viral therapeutics and is seeking to add to its existing portfolio of products through its internal discovery and clinical development programs and through an in-licensing strategy. To date, the Company has not developed commercialized any product.


Note 2. Basis of Presentation

The accompanying unaudited interim financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the Securities and Exchange Commission for Interim Reporting. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements.

In the opinion of Management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation for the interim periods have been included. Operating results for the six month period ended December 31, 2009, are not necessarily indicative of the results that may be expected for the year ending June 30, 2010. The accompanying financial statements and the information included under the heading “Management’s Discussion and Analysis or Plan of Operation” should be read in conjunction with our company’s audited financial statements and related notes included in our company’s form 10-K for the year ended June 30, 2009.


Note 3. Summary of Significant Accounting Policies

For a summary of significant accounting policies (which have not changed from June 30, 2009), see the Company’s Annual Report on Form 10-K for the year ended June 30, 2009.

Recently Issued Accounting Pronouncements
 
On June 5, 2003, the United States Securities and Exchange Commission (“SEC”) adopted final rules under Section 404 of the Sarbanes-Oxley Act of 2002 (“Section 404”), as amended by SEC Release No. 33-9072 on October 13, 2009.  Under the provisions of Section 404 of the Sarbanes-Oxley Act, public companies and their independent auditors are each required to report to the public on the effectiveness of a company’s internal controls.  The smallest public companies with a public float below $75 million have been given extra time to design, implement and document these internal controls before their auditors are required to attest to the effectiveness of these controls.  This extension of time will expire beginning with the annual reports of companies with fiscal years ending on or after June 15, 2010.  Commencing with its annual report for the fiscal year ending June 30, 2010, the Company will be required to include a report of management on its internal control over financial reporting.  The internal control report must include a statement

 
·
Of management’s responsibility for establishing and maintaining adequate internal control over its financial reporting;

 
·
Of management’s assessment of the effectiveness of its internal control over financial reporting as of year end; and

 
·
Of the framework used by management to evaluate the effectiveness of the Company’s internal control over financial reporting.
 
Furthermore, it is required to file the auditor’s attestation report separately on the Company’s internal control over financial reporting on whether it believes that the Company has maintained, in all material respects, effective internal control over financial reporting.

In June 2009, the FASB issued new accounting guidance related to accounting standards codification and the hierarchy of GAAP the “FASB Accounting Standards Codification” (“Codification”), , to become the single official source of authoritative U.S. generally accepted accounting principles (“GAAP”) to be applied by nongovernmental entities, superseding existing FASB, American Institute of Certified Public Accountants (“AICPA”), Emerging Issues Task Force (“EITF”), and related accounting literature. Rules and interpretive releases of the Securities and Exchange Commission (“SEC”) under authority of federal securities laws are also sources of authoritative U.S. GAAP for SEC registrants. This guidance reorganizes the previously issued GAAP pronouncements into accounting topics and displays them using a consistent structure. The subsequent issuances of new standards will be in the form of Accounting Standards Updates that will be included in the Codification. The guidance is effective for the Company as of the interim period ended September 30, 2009. As the Codification was not intended to change or alter existing GAAP, it did not have an impact on the Company’s consolidated financial statements. The only impact will be that references to authoritative accounting literature will be in accordance with the new numbering system prescribed by the Codification.

In August 2009, the FASB issued the FASB Accounting Standards Update No. 2009-04 “Accounting for Redeemable Equity Instruments - Amendment to Section 480-10-S99” which represents an update to section 480-10-S99, distinguishing liabilities from equity, per EITF Topic D-98, Classification and Measurement of Redeemable Securities .  The Company does not expect the adoption of this update to have a material impact on its consolidated financial position, results of operations or cash flows.

In August 2009, the FASB issued the FASB Accounting Standards Update No. 2009-05 “Fair Value Measurement and Disclosures Topic 820 – Measuring Liabilities at Fair Value” , which provides amendments to subtopic 820-10, Fair Value Measurements and Disclosures – Overall, for the fair value measurement of liabilities.  This update provides clarification that in circumstances in which a quoted price in an active market for the identical liability is not available, a reporting entity is required to measure fair value using one or more of the following techniques: 1. A valuation technique that uses: a. The quoted price of the identical liability when traded as an asset b. Quoted prices for similar liabilities or similar liabilities when traded as assets. 2. Another valuation technique that is consistent with the principles of topic 820; two examples would be an income approach, such as a present value technique, or a market approach, such as a technique that is based on the amount at the measurement date that the reporting entity would pay to transfer the identical liability or would receive to enter into the identical liability. The amendments in this update also clarify that when estimating the fair value of a liability, a reporting entity is not required to include a separate input or adjustment to other inputs relating to the existence of a restriction that prevents the transfer of the liability. The amendments in this update also clarify that both a quoted price in an active market for the identical liability when traded as an asset in an active market when no adjustments to the quoted price of the asset are required are Level 1 fair value measurements.  The Company does not expect the adoption of this update to have a material impact on its consolidated financial position, results of operations or cash flows.

In September 2009, the FASB issued the FASB Accounting Standards Update No. 2009-08 “Earnings Per Share – Amendments to Section 260-10-S99”, which represents technical corrections to topic 260-10-S99, Earnings per share, based on EITF Topic D-53, Computation of Earnings Per Share for a Period that includes a Redemption or an Induced Conversion of a Portion of a Class of Preferred Stock and EITF Topic D-42, The Effect of the Calculation of Earnings per Share for the Redemption or Induced Conversion of Preferred Stock . The Company does not expect the adoption of this update to have a material impact on its consolidated financial position, results of operations or cash flows.
 
In September 2009, the FASB issued the FASB Accounting Standards Update No. 2009-09 “Accounting for Investments-Equity Method and Joint Ventures and Accounting for Equity-Based Payments to Non-Employees” .  This update represents a correction to Section 323-10-S99-4, Accounting by an Investor for Stock-Based Compensation Granted to Employees of an Equity Method Investee . Additionally, it adds observer comment Accounting Recognition for Certain Transactions Involving Equity Instruments Granted to Other Than Employees to the Codification. The Company does not expect the adoption to have a material impact on its consolidated financial position, results of operations or cash flows.

In September 2009, the FASB issued the FASB Accounting Standards Update No. 2009-12 “Fair Value Measurements and Disclosures Topic 820 – Investment in Certain Entities That Calculate Net Assets Value Per Share (or Its Equivalent)” , which provides amendments to Subtopic 820-10, Fair Value Measurements and Disclosures-Overall, for the fair value measurement of investments in certain entities that calculate net asset value per share (or its equivalent). The amendments in this update permit, as a practical expedient, a reporting entity to measure the fair value of an investment that is within the scope of the amendments in this update on the basis of the net asset value per share of the investment (or its equivalent) if the net asset value of the investment (or its equivalent) is calculated in a manner consistent with the measurement principles of Topic 946 as of the reporting entity’s measurement date, including measurement of all or substantially all of the underlying investments of the investee in accordance with Topic 820. The amendments in this update also require disclosures by major category of investment about the attributes of investments within the scope of the amendments in this update, such as the nature of any restrictions on the investor’s ability to redeem its investments a the measurement date, any unfunded commitments (for example, a contractual commitment by the investor to invest a specified amount of additional capital at a future date to fund investments that will be make by the investee), and the investment strategies of the investees. The major category of investment is required to be determined on the basis of the nature and risks of the investment in a manner consistent with the guidance for major security types in U.S. GAAP on investments in debt and equity securities in paragraph 320-10-50-1B. The disclosures are required for all investments within the scope of the amendments in this update regardless of whether the fair value of the investment is measured using the practical expedient. The Company does not expect the adoption to have a material impact on its consolidated financial position, results of operations or cash flows.
 
In January 2010, the FASB issued the FASB Accounting Standards Update No. 2010-01 “Equity Topic 505 – Accounting for Distributions to Shareholders with Components of Stock and Cash” , which clarify that the stock portion of a distribution to shareholders that allows them to elect to receive cash or stock with a potential limitation on the total amount of cash that all shareholders can elect to receive in the aggregate is considered a share issuance that is reflected in EPS prospectively and is not a stock dividend for purposes of applying Topics 505 and 260 (Equity and Earnings Per Share (“EPS”)).  Those distributions should be accounted for and included in EPS calculations in accordance with paragraphs 480-10-25- 14 and 260-10-45-45 through 45-47 of the FASB Accounting Standards codification.  The amendments in this Update also provide a technical correction to the Accounting Standards Codification.  The correction moves guidance that was previously included in the Overview and Background Section to the definition of a stock dividend in the Master Glossary.  That guidance indicates that a stock dividend takes nothing from the property of the corporation and adds nothing to the interests of the stockholders.  It also indicates that the proportional interest of each shareholder remains the same, and is a key factor to consider in determining whether a distribution is a stock dividend.

In January 2010, the FASB issued the FASB Accounting Standards Update No. 2010-02 “Consolidation Topic 810 – Accounting and Reporting for Decreases in Ownership of a Subsidiary – a Scope Clarification” , which provides amendments to Subtopic 810-10 and related guidance within U.S. GAAP to clarify that the scope of the decrease in ownership provisions of the Subtopic and related guidance applies to the following:

 
1.
A subsidiary or group of assets that is a business or nonprofit activity

 
2.
A subsidiary that is a business or nonprofit activity that is transferred to an equity method investee or joint venture

 
3.
An exchange of a group of assets that constitutes a business or nonprofit activity for a noncontrolling interest in an entity (including an equity method investee or joint venture).

The amendments in this Update also clarify that the decrease in ownership guidance in Subtopic 810-10 does not apply to the following transactions even if they involve businesses:

 
1.
Sales of in substance real estate.  Entities should apply the sale of real estate guidance in Subtopics 360-20 (Property, Plant, and Equipment) and 976-605 (Retail/Land) to such transactions.

 
2.
Conveyances of oil and gas mineral rights.  Entities should apply the mineral property conveyance and related transactions guidance in Subtopic 932-360 (Oil and Gas-Property, Plant, and Equipment) to such transactions.

If a decrease in ownership occurs in a subsidiary that is not a business or nonprofit activity, an entity first needs to consider whether the substance of the transaction causing the decrease in ownership is addressed in other U.S. GAAP, such as transfers of financial assets, revenue recognition, exchanges of nonmonetary assets, sales of in substance real estate, or conveyances of oil and gas mineral rights, and apply that guidance as applicable. If no other guidance exists, an entity should apply the guidance in Subtopic 810-10.

Management does not believe that any other recently issued, but not yet effective accounting pronouncements, if adopted, would have a material effect on the accompanying financial statements.
 
Reclassification

Certain reclassifications have been made in prior year’s financial statements to conform to classification used in the current year.  The reclassifications from general and administrative expenses to research and development expenses does not change total operating expenses, operating loss or net loss for any period presented.


Note 4.  Substantial Doubt Regarding Ability to Continue as a Going Concern

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. Accordingly, they do not include any adjustments relating to the realization of the carrying value of assets or the amounts and classification of liabilities that might be necessary should the company be unable to continue as a going concern.  The Company’s significant operating losses and significant capital requirements, however, raise substantial doubt about the Company’s ability to continue as a going concern.

Since May 2005, the Company has been engaged exclusively in research and development activities focused on developing targeted nano viral drugs.  The Company has not yet commenced any product commercialization. The Company has incurred significant operating losses since its inception, resulting in a deficit accumulated during the development stage of $13,652,172 at December 31, 2009. Such losses are expected to continue for the foreseeable future and until such time, if ever, as the Company is able to attain sales levels sufficient to support its operations. There can be no assurance that the Company will achieve or maintain profitability in the future. Despite the Company’s financings in 2009 and 2008 and a cash and cash equivalent balance of $4,032,863 at December 31, 2009, substantial additional financing will be required in future periods. The Company believes it will require an additional $3,000,000 during the next twenty four months, and will also require up to an additional $2,000,000 to finance planned capital costs, and additional staffing requirements during the next twenty four months. The Company believes it can adjust its priorities of drug development, and its Plan of Operations as necessary if it is unable to raise such funds.

The Company continues to successfully raise additional capital, On September 30, 2009, the Company accepted subscriptions from certain investors in the aggregate amount of $3,217,400 from the offerings of shares of the Company ’s common stock and warrants to purchase common stock and the exercise by the Company’s warrant holders of their outstanding warrants.  The offerings were commenced in June 2009, when the Company’s stock price levels were approximately $0.57.  The offerings were closed to investors on August 30, 2009, after an extension by the Company’s Board of Directors from the original termination date of August 14, 2009.  In the Company’s offering of Units comprised of shares of common stock and warrants to purchase common stock, the Company accepted subscriptions for $1,337,500 for Units consisting of 2,675,000 shares and Warrants to purchase an additional 1,337,500 shares.  In the offering to its warrant holders, the Company raised an aggregate of $1,879,900 for 3,759,800 shares and warrants to purchase 3,759,800 shares.  All of the warrants sold in the offerings are exercisable at the price of $1.00 per share and expire in three years.

The Company is in discussions with certain potential investors to provide the additional capital set forth above. Additionally, A grant application for developing a broad-spectrum nanoviricide against hemorrhagic fever viruses such as Ebola/Marburg and Dengue is currently pending with the Department of Defense. No assurances can be given that financing will be available or be sufficient to meet our capital needs.  If we are unable to obtain financing to meet our working capital requirements, then we may be required to modify our operations, including curtailing our business significantly or ceasing operations altogether.
 

Note 5. Significant Alliances and Related Parties

TheraCour Pharma, Inc.

Pursuant to an Exclusive License Agreement we entered into with TheraCour Pharma, Inc., (TheraCour), the Company was granted exclusive licenses in perpetuity for technologies developed by TheraCour for the virus types: Human Immunodeficiency Virus (HIV/AIDS), Influenza including Asian Bird Flu Virus, Herpes Simplex Virus (HSV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), and Rabies. The Company and TheraCour have agreed, in principle, to a Licensing Agreement to include additional virus types among the virus types the Company is permitted to manufacture, use, and offer for sale, and for payment of a license fee to TheraCour. The Company has entered into an Additional License Agreement with TheraCour granting the Company the exclusive licenses in perpetuity for technologies developed by TheraCour for the additional virus types for Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Viruses causing viral Conjunctivitis (a disease of the eye) and Ocular Herpes, and Ebola/Marburg viruses.


In consideration for obtaining these exclusive licenses, we agreed: (1) that TheraCour can charge its costs (direct and indirect) plus no more than 30% of direct costs as a Development Fee and such development fees shall be due and payable in periodic installments as billed.  (2) to pay $25,000 per month for usage of lab supplies and chemicals from existing stock held by TheraCour (3) we will pay $2,000 or actual costs, whichever is higher, for other general and administrative expenses incurred by TheraCour on our behalf (4) make royalty payments (calculated as a percentage of net sales of the licensed drugs) of 15% to TheraCour Pharma, Inc. (5) agreed that TheraCour Pharma, Inc. retains the exclusive right to develop and manufacture the licensed drugs. TheraCour Pharma, Inc. agreed that it will manufacture the licensed drugs exclusively for NanoViricides, and unless such license is terminated, will not manufacture such product for its own sake or for others, (6) TheraCour may request and NanoViricides, Inc. will pay an advance payment (refundable) equal to twice the amount of the previous months invoice to be applied as a prepayment towards expenses.

There can be no assurance that the license fee will be paid or that the amendment will become effective, in which case TheraCour may revoke our permissive use of its materials, which may adversely impact our operations and cause the termination of our Cooperative Research and Development Agreement (CRADA) with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID), and the United States Armed Forces Institute of Pathology (USAFIP).

TheraCour may terminate the license upon a material breach by us as specified in the agreement. However, we may avoid such termination if within 90 days of receipt of such termination notice we cure the breach.

Development costs charged by TheraCour Pharma, Inc. for the six months ended December 31, 2009 and 2008, were $586,023 and $417,093 respectively, and$3,151,071 since inception.  As of December 31, 2009, pursuant to its license agreement the Company has paid a security advance of $263,656 to and held by TheraCour Pharma, Inc. which is reflected in prepaid expenses

No royalties are due TheraCour from the Company’s inception through December 31, 2009.

On February 27, 2007, NanoViricides, Inc. entered into a sublease to occupy 5,000 square feet of space in Woodbridge, Connecticut. Performance of the Company’s obligations was guaranteed by TheraCour Pharma, Inc., a principal shareholder of the Company and provider of the materials the Company uses in its operations. This lease expired on January 30, 2009, and we have relocated our operations to an expanded facility at 135 Wood Street, West Haven, CT.
 
TheraCour Pharma, Inc., is affiliated with the Company through the common control of it and our Company by Anil Diwan, President,  who is a director of each corporation, and owns approximately 70% of the capital stock of TheraCour Pharma, Inc., which itself owns approximately 30% of the capital stock of the Company.
 
TheraCour Pharma, Inc. owns 31,460,000 shares of the Company’s outstanding common stock as of December 31, 2009. The Company anticipates the need to procure large quantities of the nanoviricides drug candidates for the upcoming studies. In order to support this production scale, TheraCour Pharma, Inc., the Company’s largest shareholder and licensor of the TheraCour® technology that the Company uses in its anti-viral drug development, has initiated a program to expand its laboratory facilities. On December 3, 2009 TheraCour concluded its sales of the Company’s stock pursuant to a Rule 10b5-1 trading plan selling, over a one year period, 1.8 million shares of the Company’s common stock..  The plan went into effect on February 17, 2009. The proceeds are expected to be used to pay for necessary improvements in laboratory facilities, the purchase of analytical equipment, and the costs of intellectual property (patent) protection.
 

The FASB has issued guidance related Consolidation of Variable Interest Entities. The guidance clarifies the application to certain entities in which equity investors do not have the characteristics of a controlling financial interest or do not have sufficient equity at risk for the entity to finance its activities without additional subordinated financial support from other parties. It separates entities into two groups: (1) those for which voting interests are used to determine consolidation and (2) those for which variable interests are used to determine consolidation The guidance clarifies how to identify a variable interest entity and how to determine when a business enterprise should include the assets, liabilities, non-controlling interests, and results of activities of a variable interest entity in its consolidated financial statements.

The guidance further requires that a variable interest entity to be consolidated by its “Primary Beneficiary.” The Primary Beneficiary is the entity, if any, that stands to absorb a majority of the variable interest entity’s expected losses, or in the event that no entity stands to absorb a majority of the expected losses, then the entity that stands to receive a majority of the variable interest entity’s expected residual returns. If it is reasonably possible that an enterprise will consolidate or disclose information about a variable interest entity when the FASB guidance became effective, the enterprise is required to disclose in all financial statements initially issued after December 31, 2003, the nature, purpose, size, and activities of the variable interest entity and the enterprise’s maximum exposure to loss as a result of its involvement with the variable interest entity. For all periods presented in the financial statements, the Company evaluated its relationship with TheraCour Pharma, Inc., and concluded that it is not a variable interest entity that is subject to consolidation in the Company’s financial statements.
 
KARD Scientific, Inc.
 
In June 2005, the Company engaged KARD Scientific to conduct pre clinical animal studies and provide the Company with a full history of the study and final report with the data collected. Dr. Krishna Menon, the Company’s Chief Regulatory Officer, is also an officer and principal owner of KARD Scientific. Since inception, lab fees charged by KARD Scientific for services to the Company total. $633,175.
 
 
Note 6. Prepaid Expenses

Prepaid expenses are summarized as follows:

   
December 31, 2009
   
June 30, 2009
 
             
TheraCour Pharma, Inc. *
  $ 263,656     $ 243,313  
Kard Scientific, Inc. *
    -       50,000  
Prepaid other
    49,248       28,232  
    $ 312,904     $ 321,545  

(* See Note 5. Significant Alliances and Related Parties)
 

Note 7. Equity Transactions

In November 2009, the Scientific Advisory Board (SAB) was granted warrants to purchase 50,000 shares of common stock at $1.06 per share. These warrants, if not exercised, will expire in November 2013. The fair value of these warrants in the amount of$39,600 was recorded as consulting expense.

The fair value of the Company’s option-based awards granted were estimated using the Black-Scholes option pricing model and the following assumptions.

  For the three months   For the six months
 
ended 12/31/09
 
ended 12/31/09
Expected life in years
4 yrs
   
4 yrs
Risk free interest rate
1.73%
   
1.73-2.06%
Expected volatility
92.94%
   
92.94-96.15%
Dividend yield
0%
   
0%


On September 30, 2009, the Company accepted subscriptions from certain investors in the aggregate amount of $3,217,400 from the offerings of shares of the Company’s common stock and warrants to purchase common stock and the exercise by the Company’s warrantholders of their outstanding warrants.  The offerings were commenced in June 2009, when the Company’s stock price levels were approximately $0.57.  The offerings were closed to investors on August 30, 2009, after an extension by the Company’s Board of Directors from the original termination date of August 14, 2009.  In the Company’s offering of Units comprised of shares of common stock and warrants to purchase common stock, the Company accepted subscriptions for $1,337,500 for Units consisting of 2,675,000 shares and Warrants to purchase an additional 1,337,500 shares.  In the offering to its warrant holders, the Company raised an aggregate of $1,879,900 for 3,759,800 shares and warrants to purchase 3,759,800 shares.  All of the warrants sold in the offerings are exercisable at the price of $1.00 per share and expire three years from the issue date.

For the six months ended December 31, 2009, the Company's Board of Directors authorized the issuance of 93,530 shares of its common stock with a restrictive legend, for consulting services. The Company recorded an expense of $64,463.


Note 8. Commitments and Contingencies

Operating Leases
The Company’s principal executive offices are located at 135 Wood Street, West Haven, Connecticut, and include approximately 7,000 square feet of office and laboratory space at a base monthly rent of $7,311. Commencing September 1, 2008 the Company rented additional storage space and the base monthly rent increased to $7,311. The term of lease expires in February 28, 2011, and may be extended, at the option of the Company, for an additional two years. The lease can be cancelled by the Company upon providing six months written notice.
 
On February 27, 2007, NanoViricides, Inc. entered into a sublease to occupy 5,000 square feet of space at 4 Research Drive, in Woodbridge, Connecticut. The term of the occupancy expired January 30, 2009 at a monthly rent of $11,667, plus an additional $500 per month for utilities.

At December 31, 2009, future minimum rental payments due under these operating leases are as follows:

2010
$43,866866

Total rent expense amounts to $36,556 and $106,654 for the six months ended December 31, 2009 and 2008 respectively, and$333,310 for the period from inception.
 
 
Note 9. Subsequent Events
 
The Company has evaluated all events that occurred after the balance sheet date of December 31, 2009 through February , 2009, the date when the financial statements were issued.  The Management of the Company determined that the following were reportable events that occurred during that subsequent period which were required to be disclosed:
 
On February 15, 2010, the Company’s Board of Directors approved the Amended By-Laws to be effective as of February 15, 2010.

On February 8, 2010, the Company announced that it signed a research and development agreement with Dr. Eva Harris’s laboratory at the University of California, Berkeley (UC Berkeley).  Pursuant to the terms of this agreement, Dr. Harris and UC Berkley will evaluate the effectiveness of nanoviricides drug candidates against various dengue viruses. Cell cultures models as well as in vivo animal studies will be employed for testing the drug candidates.  Dr. Eva Harris is a Professor of Infectious Diseases at UC Berkeley and a leading researcher in the field of dengue.

On February 15, 2010 the Company approved an Additional License Agreement with TheraCour Pharma, Inc. (“TheraCour”).  Pursuant to the exclusive Additional License Agreement, the Company was granted exclusive licenses, in perpetuity, for technologies, developed by TheraCour, for  the development of drug candidates for the treatment of  Dengue viruses, Ebola/Marburg viruses, Japanese Encephalitis, viruses causing viral Conjunctivitis (a disease of the eye) and Ocular Herpes.  As consideration for obtaining these exclusive licenses, we agreed to pay a one time licensing fee equal to seven million shares of the Company’s Series A Convertible Preferred Stock (the “Series A Preferred Stock”).  The Series A Preferred Stock is convertible, only upon sale or merger of the company, or the sale of or license of substantially all of the Company’s intellectual property, into shares of the Company’s common stock at the rate of four shares of common stock for each share of Series A Preferred Stock.  The Series A Preferred Stock has a preferred voting preference at the rate of four votes per share.  In addition, the Company agreed: (i) that, to the extent not being paid under the existing license agreement that TheraCour can charge its costs (direct and indirect) plus no more than 30% of direct costs as a development fee which shall be due and payable in periodic installments as billed; (ii) that, to the extent not being paid under the existing license agreement, a development fee of  $25,000 per month for usage of lab supplies and chemicals from TheraCour’s existing stock ; (iii) the Company will pay TheraCour the amount of $2,000 or actual costs, whichever is greater, for other general and administrative expenses incurred by TheraCour on our behalf; (iv) make royalty payments (calculated as a percentage of net sales of the licensed drugs) of 15% to TheraCour; (5) TheraCour shall retain the exclusive right to develop and manufacture the licensed drugs; and (vi) TheraCour may request the Company to pay an advance payment (refundable) equal to twice the amount of the previous months invoice to be applied as a prepayment towards expenses. The Company does not anticipate any material increase in direct payments for development fees or for general and administrative expenses, to TheraCour, as a result of this Additional License Agreement.


IT EM 2.  MANAGEMENT'S DISCUSSION AND ANALYSIS OR PLAN OF OPERATION

The following discussion and analysis should be read in conjunction with our unaudited financial statements and related notes included in this report. This report contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The statements contained in this report that are not historic in nature, particularly those that utilize terminology such as "may," "will," "should," "expects," "anticipates," "estimates," "believes," or "plans" or comparable terminology are forward-looking statements based on current expectations and assumptions.

Various risks and uncertainties could cause actual results to differ materially from those expressed in forward-looking statements. All forward-looking statements in this document are based on information currently available to us as of the date of this report, and we assume no obligation to update any forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements.

OUR CORPORATE HISTORY

NanoViricides, Inc. was incorporated under the laws of the State of Colorado on July 25, 2000 as Edot-com.com, Inc . and was organized for the purpose of conducting internet retail sales. On April 1, 2005, Edot-com.com, Inc.   was incorporated under the laws of the State of Nevada for the purpose of re-domiciling the Company as a Nevada corporation, Edot-com.com (Nevada). On April 15, 2005, Edot-com.com (Colorado) and Edot-com.com (Nevada) were merged and Edot-com.com, Inc., (ECMM)   a Nevada corporation, became the surviving entity. On April 15, 2005, the authorized shares of common stock was increased to 300,000,000 shares at $.001 par value and the Company effected a 3.2 - 1 forward stock split effective May 12, 2005.

On June 1, 2005, Edot-com.com, Inc. acquired NanoViricides, Inc., a privately owned Florida corporation (“NVI”), pursuant to an Agreement and Plan of Share Exchange (the “Exchange”). NVI was incorporated under the laws of the State of Florida on May 12, 2005 and its sole asset was comprised of a licensing agreement with TheraCour Pharma, Inc. (“TheraCour,” an approximately 30% shareholder of NVI) for rights to develop and commercialize novel and specifically targeted drugs based on TheraCour's targeting technologies, against a number of human viral diseases. (For financial accounting purposes, the acquisition was a reverse acquisition of the Company by NVI, under the purchase method of accounting, and was treated as a recapitalization with NVI as the acquirer). Upon consummation of the Exchange, ECMM adopted the business plan of NVI.

Pursuant to the terms of the Exchange, ECMM acquired NVI in exchange for an aggregate of 80,000,000 newly issued shares of ECMM common stock, resulting in an aggregate of 100,000,000 shares of ECMM common stock issued and outstanding. As a result of the Exchange, NVI became a wholly-owned subsidiary of ECMM. The ECMM shares were issued to the NVI Shareholders on a pro rata basis, on the basis of 4,000 shares of the ECMM Common Stock for each share of NVI common stock held by such NVI Shareholder at the time of the Exchange.


On June 28, 2005,  NVI was merged into its parent ECMM and the separate corporate existence of NVI ceased. Effective on the same date, Edot-com.com, Inc., changed its name to NanoViricides, Inc. and its stock symbol on the Pink Sheets to “NNVC.  The Company submitted a Form-10SB to the SEC to become a reporting company on November 14,  2006. The Company’s filing status became effective in March, 2007.  On June 28, 2007, the company became quotable on The OTC Bulletin Board under the symbol NNVC.OB.

The Company is considered a development stage company at this time.

Management’s Plan of Operation

NanoViricides, Inc. (the “Company”), is an early developmental stage nano-biopharmaceutical company engaged in the discovery, development and commercialization of anti-viral therapeutics. The Company has no customers, products or revenues to date, and may never achieve revenues or profitable operations. Our drugs are based on several patents, patent applications, provisional patent applications, and other proprietary intellectual property held by TheraCour Pharma, Inc., one of the Company’s principal shareholders, from which we have licensed, in perpetuity,  the right to develop drug candidates for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Influenza including Asian Bird Flu Virus, Herpes Simplex Virus (HSV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), and Rabies. The Company and TheraCour have agreed, in principle, to a Licensing Agreement to include additional virus types among the virus types the Company is permitted to manufacture, use, and offer for sale, and for payment of a license fee to TheraCour. The Company has entered into an Additional License Agreement with TheraCour granting the Company the exclusive licenses in perpetuity for technologies developed by TheraCour for the additional virus types for Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Viruses causing viral Conjunctivitis (a disease of the eye) and Ocular Herpes, and Ebola/Marburg viruses.

We are seeking to add to our existing portfolio of products through our internal discovery pre-clinical development programs and through an in-licensing strategy. We focus our laboratory research and pre-clinical programs on specific anti-viral solutions.

The Company has incurred significant operating losses since its inception resulting in an accumulated deficit of $13,652,172 at December 31, 2009. For the six months ended December 31, 2009 the Company had a net loss of$1,656,637. Such losses are expected to continue for the foreseeable future and until such time, if ever, as the Company is able to attain sales levels sufficient to support its operations.

To date, we have engaged in organizational activities; sourcing compounds and materials; developing novel compounds and nanomaterials, and experimentation with studies on cell cultures and animals. We have generated funding through the issuances of debt and private placement of common stock.  We have not generated any revenues and we do not expect to generate revenues in the near future. We may not be successful in developing our drugs and start selling our products when planned, or that we will become profitable in the future. We have incurred net losses in each fiscal period since inception of our operations. The Company currently has no long term debt.

NanoViricides Technologies, Products in Development, and Collaborations

Pharmaceutical drug development is an expensive and long duration proposition. Management’s plan is to develop each of our nanoviricides® to the necessary stage(s) and then engage into co-development relationships with other pharmaceutical companies. Such co-development relationships usually may entail upfront payments, milestones payments, cost-sharing, and eventual revenue-sharing, including royalty on sales. There is no guarantee that we will be able to negotiate agreements that are financially beneficial to the Company at the present stage. Management plans to continue to raise additional funds as needed for our continuing drug development efforts on public markets.

The Company currently has several drug development programs. Our drug development programs with large commercial interest include (1) Influenzas, (2) HIV, (3) topical eye drops for viral diseases of the external eye, and (4) Herpes “cold sores” and genital Herpes. In addition, the Company believes that, as the holder of potentially paradigm-shifting antiviral drug development technologies, it has a social responsibility to develop drugs against diseases affecting large segments of worldwide populations. In our Social Responsibility programs, we are developing drugs against Neglected Tropical Diseases (NTDs) caused by viruses such as Dengue viruses and Rabies. The Company also has BioSecurity programs that include drug development against hemorrhagic fever viruses such as Ebola/Marburg, and a unique technology that we call “ADIF” to combat natural or bioterrorism attacks by novel viruses as happened with SARS and may happen with engineered viruses. The Company plans to perform its NTD and BioSecurity R&D and drug development in collaboration with institutes of renown and with public funding, in order to minimize the strain on our resources. The Company believes that this work provides direct benefits to our commercially important programs. A grant application for developing a broad-spectrum nanoviricide against hemorrhagic fever viruses such as Ebola/Marburg and Dengue is currently pending with the Department of Defense.


Our development model is to employ collaborations with academic labs, government labs, as well as external service providers in order to minimize our capital requirements. We currently have collaborations with the Center for Disease Control and Prevention (CDC) and the National (Central) Institute of Hygiene and Epidemiology (NIHE) (Vietnam) for Rabies, with NIHE for H5N1 Avian Flu, the Walter Reed Army Institute of Research (WRAIR) for Dengue family viruses, the Eva Harris Lab at the University of California Berkeley for Dengue, United States Army Medical Institute of Infectious Diseases (USAMRIID) for Ebola/Marburg family of hemorrhagic viruses, and the Long Island Jewish Medical System, Feinstein Institute of Medical Research (LIJMS) for viral eye diseases such as epidemic kerato-conjunctivitis (EKC) and herpes keratitis.  In addition, our HIV and common influenza studies were subcontracted to KARD Scientific, Inc., USA. Some of the biological testing work for Herpes Virus infection of the eye was subcontracted to TheVac, LLC, laboratories at the Louisiana Emerging Technology Center located within the Louisiana State University (LSU) campus in collaboration with the LSU School of Veterinary Medicine. We have recently signed a Master Service Agreement to subcontract evaluation of nanoviricide drug candidates against various diseases including Influenzas and HIV with the Southern Research Institute, Infectious Diseases Division, Frederick, MD (SRI-F), a well known contract research organization that performs preclinical testing.  Initially, we plan to perform additional testing of influenza dug candidates including High-Path or Highly Pathogenic Avian Influenzas (i.e. HPAI) at SRI-F. In addition to H5N1, several H9N and H7N influenza virus subtypes are highly pathogenic and have caused or have the potential to cause severe influenza epidemics.  We also plan to perform additional testing of our HIV drug candidates at SRI-F.

We have additional collaborations in the process of formalization for work on Dengue viruses, HIV, Viral Conjunctivitis, HSV “cold sores” and genital herpes, and other viruses. We typically employ more than one external laboratory to perform testing for a particular disease agent in order to limit possible laboratory level bias.

We have developed lead drug candidates against a number of viral diseases. Proof-of-principle efficacy studies in animals have been conducted successfully in many of these.

Nanoviricides are designed to work by binding to and eliminating virus particles from the blood-stream, just as antibodies do, only potentially much better. This is expected to result in reduction in viremia. A nanoviricide is constructed by chemically attaching a ligand designed to bind to virus particle, to a polymeric material that forms a flexible nanomicelle by self-assembly. If antibodies are known to affect a viral disease, it is possible to construct a nanoviricide against it, and there can be a general expectation of some success, depending upon the ligand chosen. We can choose a ligand from any of a number of chemical classes, including small chemicals, peptides, or antibody fragments or even whole antibodies.

The NanoViricides’ Concept and Antiviral Strategy

The Company owns an exclusive worldwide license in perpetuity to technology that enables the creation of nanoviricides. A “nanoviricide” is a flexible nano-scale material approximately a few billionths of a meter in size, comparable to the size of a virus particle, which is chemically programmed by a “ligand” to specifically target and attack a particular type of virus. A nanoviricide also is capable of simultaneously delivering a devastating payload of active pharmaceutical ingredients (API) into the virus particle, to destroy its genome (RNA/DNA).

A nanoviricide is designed to “look like” the portion of a cell membrane with the cell receptor to which a virus particle binds, in a sense. This biomimetic approach is expected to fool the virus into binding to the nanoviricide, and in an attempt to “enter” it, it is thought that the virus particle may get destroyed. This is because viruses have developed ways of uncoating themselves once they enter a cell, in order to expose the viral genomic material so that it can hijack the cellular machinery to make its own copies. We call this the “passive view” of how a nanoviricide may work.


A nanoviricide is designed as a flexible material, that self-assembles, at about the same size scale as a typical virus particle. The flexible material we use is one type of a special polymeric material called TheraCour®, invented by the Company’s founders. It assembles in solution into a flexible ball, somewhat like a ball of hair. We call this a nanoviricide micelle, or “nanomicelle” for short. On first contact with a virus particle, a nanoviricide micelle may bind to a virus particle because of specific interaction between a ligand attached to the nanoviricide and the glycoproteins on the virus surface. This may cause the flexible nanoviricide to reach very close to the virus surface, leading to additional ligands binding to additional viral coat proteins, in a mode called “cooperative binding”.  Cooperative binding is a well known natural process that forms the basis of biological recognition such as antibody-antigen binding, DNA hybridization, and protein assembly, among others. Eventually it is thought that the interior of the nanomicelle, which is lipidic (oil-like) in nature, would fuse with the exterior lipidic coat of the virus particle. This lipidic fusion is also a well known natural process. Such fusion may lead to the flexible nanomicelle spreading onto the virus surface much like an oil-slick covering a golf ball. In the process, the coat proteins that the virus uses for binding to cells may be expected to become unavailable, and are also likely to even get stripped off completely. The virus particle would then be rendered incapable of binding to a cell, and thus no longer infectious or capable of causing disease or of making copies of itself. We call this the “active view” of how a nanoviricide may work.

Nanoviricides thus are designed to employ the “Bind-Encapsulate-Destroy” strategy, which is akin to the “Find-Encircle-Destroy” war strategy that has been successfully employed historically in many wars.

Antibodies are a major defense of humans and animals against viruses. After a person is infected by one particular virus, he/she develops antibodies against the virus. The infection is fully controlled after a strong antibody response develops. Subsequent exposure to the same virus does not cause disease. However, antibodies by themselves do not destroy a virus particle. After a few antibodies bind to a virus particle, several processes must take place that eventually lead to destruction of the virus particle. Many viruses have developed ways of dysregulating this complex immune response cascade.

Nanoviricides, on the other hand, are designed as “programmed nanomachines” capable of executing the entire strategy of “Bind-Encapsulate-Destroy” without any dependence on or assistance from the human immune system.

Antibodies also may be too specific to a particular virus strain, and thus viruses evade antibodies by changing their external surface. Vaccines create antibodies in the recipient, in order to protect the person. Vaccines are thus limited by the nature of antibodies, and tend to be very specific to particular strains or groups of strains of a virus. This is why a new seasonal vaccine must be formulated for influenza every year. This is also why a novel influenza strain such as bird flu (H5N1) or the 2009 ”Swine flu” virus cannot be defended against by existing vaccines.  In addition, novel vaccines against the novel strain cannot be  developed and manufactured in time, as was demonstrated during the 2009 “swine Flu” pandemic.

Despite all evolutionary/spontaneous changes such as mutations, re-assortments, recombinations, etc., a particular virus retains its ability to bind to the same cell receptor features on the cell surface at the same sites. In designing a nanoviricide, we pay particular attention to the design and selection of a ligand. We generally choose a ligand that mimics the cell surface features to which all virus strains of a particular virus are known to bind. We therefore believe that a resistant viral strain against a nanoviricide would be far less likely to occur than resistance development against any other antiviral agent strategy. If, however, such resistance does occur, a new nanoviricide can be developed by changing the ligand appropriately.

We designed the nanoviricides to act by a novel set of multiple, concerted , mechanisms. However, being so novel, our drugs are not directly comparable to existing anti-viral therapies. Thus, the safety and efficacy of the nanoviricides needs to be established by experimentation, and cannot be anticipated on the basis of any similar information regarding existing drugs.


It is important to realize that the flexible nanoviricides nanomedicines show substantial advantages over hard sphere nanoparticles in this antiviral drug application. Hard sphere nanomaterials such as dendritic materials (dendrimers), nanogold shells, silica, gold or titanium nanospheres, polymeric particles, etc., were never designed to be capable of completely enveloping and neutralizing the virus particle.

The Company does not claim to be creating a cure for viral diseases. The Company's objectives are to create the best possible anti-viral nanoviricides and then subject these compounds to rigorous laboratory and animal testing towards US FDA and international regulatory approvals. Our long-term research efforts are aimed at augmenting the nanoviricides that we currently have in development with additional therapeutic agents to produce further improved anti-viral agents in the future.

The Company plans to develop several drugs through the preclinical studies and clinical trial phases with the goal of eventually obtaining approval from the United States Food and Drug Administration (“FDA”) and International regulatory agencies for these drugs. The Company plans, when appropriate, to seek regulatory approvals in several international markets, including developed markets such as Europe, Japan, Canada, Australia, and Emerging Regions such as Southeast Asia, India, China, Central and South America, as well as the African subcontinent. The seeking of these regulatory approvals would only come when and if one or more of our drugs, now in early stage of pre-clinical development, has significantly advanced through the US FDA regulatory process. If and as these advances occur, the Company may attempt to partner with more established pharmaceutical companies to advance the various drugs through the approval process.

There can be no assurance that the Company will be able to develop effective nanoviricides, or if developed, that we will have sufficient resources to be able to successfully manufacture and market these products to commence revenue-generating operations.

There can be no assurance that other developments in the field would not impact our business plan adversely. For example, successful creation and availability of an effective vaccine may reduce the potential market size for a particular viral disease.

The Company's headquarters are currently in West Haven, Connecticut.

We plan on undertaking the development of drugs against other viruses when adequate financing becomes available. The Company's ability to achieve progress in the drugs in development is dependent upon available financing and upon the Company's ability to raise capital.  The Company will negotiate with TheraCour to obtain licenses for additional viral diseases as necessary. However, there can be no assurance that TheraCour will agree to license these materials to the Company, or to do so on terms that are favorable to the Company.

The total market size of drugs for the programs in which we already have lead drug candidates are estimated to be over $40B in 2013.

 “H1N1 Swine Flu”, Common Influenzas, High Path Avian Influenzas, Bird Flu, Epidemic and Pandemic Influenzas

Our FluCide program lead drug candidate has shown efficacies animals that far exceed that of known drugs such as oseltamivir (Tamiflu®, Roche) against common influenza in an animal model. Until last year, we had three different drug development programs for influenzas: FluCide for common influenzas, FluCide-HP for highly pathogenic influenzas, and AviFluCide specific to H5N1 bird flu. We have consolidated all three of our influenza drug programs into a single, broadly active, yet highly effective, pan-influenza FluCide program. The new FluCide is expected to be highly active against all influenzas, including highly pathogenic strains such as H5N1, the novel H1N1/2009 Mexico/California “Swine Flu” epidemic strain, H3N2, H7N, and H9N among others. We are currently developing a single drug for all influenzas, whether pandemic, epidemic, seasonal, novel, emerging, human, swine, or avian. We anticipate significant cost savings as well as simplification in regulatory and eventual marketing efforts by consolidating these drug programs.

Recently, with additional SAR (structure-activity-relationship) studies, we have been able to develop influenza virus binding ligands that are expected to be superior to the previously used ligands in FluCide-HP. The new ligands are designed to be closer mimics of the sialic acid receptors (than the previously employed ones), yet capable of binding to influenza virus hemagglutinin proteins that use either the “avian” or the “human” types of sialic acid receptors. Pigs are known to be a “mixing vessel” species, exhibiting both avian and human types of sialic acid receptors, and thereby re-assortment (mixing) of genetic material from influenza strains, subtypes, or types, with different host specificities can occur readily in pigs. We are actively seeking partnerships, collaborations and government funding for our anti-influenza drug program.


Viral Diseases of the Eye: Viral Conjunctivitis, Viral Keratitis – Eye Drops

We are developing a nanoviricide against adenoviral Epidemic Kerato-Conjunctivits (EKC). EKC is a severe disease of the eye which in some people causes long term or permanent blurred vision. In an animal study, our EKCCide lead candidate was shown to rapidly resolve the clinical signs of the disease, when treatment was started after infection had set in. The clinical success included demonstration that no SEI’s (immunoprecipitates) were formed in treated animals, as opposed to control group. SEI’s are known to be the cause of blurred vision. There are currently no approved drugs available against EKC, and it is an active field of drug development research. There are about 2.5 million cases of EKC annually in the USA alone.

The Company is not aware of any animal studies of anti-EKC drug candidates that have demonstrated resolution of clinical disease. Based on these successful results, we expanded our program to develop a single broad-spectrum nanoviricide treatment effective against most of the viruses causing external eye diseases, including viral conjunctivitis and viral keratitis. A large majority of external eye viral infections are caused by adenoviruses or herpes simplex viruses (mainly HSV-1).

We have now successfully developed drug candidates that are effective against both adenoviruses and against HSV-1, viruses that cause most of the viral diseases of the external eye. Additional animal testing against HSV-1 infection of the eye is being commissioned at two independent external research centers.

HSV and some adenoviruses cause most of the cases of keratitis, a serious infection of the cornea (approximately 250,000 US cases/year). Importantly, HSV infection can lead to corneal scarring that may necessitate corneal transplantation.  In addition, some adenoviruses cause a majority of conjunctivitis cases (“Pink eye”).  The remaining cases of conjunctivitis are caused by bacteria and are treatable with topical antibiotics.  Currently there are no effective treatments for viral diseases of the exterior portion of the eye.

The nanoviricide eye drug candidate is formulated as simple eye drops.

The total market for viral conjunctivitis and keratitis is estimated to be in the billions of dollars.  The incidence of severe herpes keratitis is estimated to be 250,000 cases per year in the USA.  In Japan, where EKC is a reportable disease, it is estimated that there are at least one million cases per year.  The number of cases of non-specific conjunctivitis (pink eye) is considered to be far greater, possibly into the tens of millions in the US and hundreds of millions worldwide.

The Company reported on February 27, 2009 that it entered into a Material Transfer Agreement with a major pharmaceutical company.  Pursuant to the terms of the agreement, the Company is not authorized to disclose the identity or the terms of the Agreement, except for securities reporting purposes.  The pharmaceutical company will evaluate one of the Company’s compounds as a drug candidate for certain viral infections of the external eye.  The Agreement also provides that following evaluation, should the pharmaceutical company so elect, the parties may enter into good faith negotiations for an exclusive, worldwide license for drug development and commercialization of the eye drug candidate.  The initial phase of evaluation was completed recently.

On May 6, 2009, the Company entered into a Clinical Study Agreement with TheVac, LLC, a company affiliated with the Emerging Technology Center of the Louisiana State University. At present, TheVac is performing biological testing of anti-herpes nanoviricides. TheVac is conducting studies on the effect of anti-herpes nanoviricide drug candidates developed for use against herpes cold sores and genital herpes in cell culture models. In addition, TheVac is also conducting studies on the effect of anti-herpes nanoviricides drug candidates in a mouse model of herpes keratitis. Professor Gus Kousoulas and his team at Louisiana State University have validated and published on this animal model extensively in peer-reviewed scientific journals.


HIV

Our very first animal studies in the standard SCID-hu mice against HIV-I have demonstrated that our primary nanoviricide drug candidate, HIVCide, as well as several other  nanoviricide drug candidates were found to be superior to the three-drug oral cocktail (HAART) that is the current standard of care.

We designed the anti-HIV nanoviricides using rational drug design principles. The ligands we have designed in the case of HIV-1 are thought to be broadly neutralizing. In-silico modeling indicates that our ligands dock to the conserved CD4 binding site of gp120 of HIV-1. We have even observed successful docking of some of our ligands with gp120 of the HIV-1 JRFL strain which is thought to be resistant to HAART.

Resistance to HAART eventually leads to AIDS. It is possible that HIVCide can be used in addition to HAART to obtain even stronger beneficial effects, resulting in a “functional cure” of HIV.  We believe that the term “Functional Cure” of HIV may be defined as: The HIV genome integrates into certain human cells that go into hiding or dormancy for several years. While dormant, the HIV genome does not produce HIV virus particles or HIV proteins to any significant extent and are thought to remain unaffected by current anti-HIV drugs. The current standard treatment results in very low levels of HIV viremia, but the immune cells (CD4+ T cells and CD8+T cells) count eventually begins decreasing at a slow rate. The HAART therapy must be continued for the life of the patient.  A more effective therapy could result in complete loss of HIV from the blood stream.  This may eliminate the slow loss of healthy immune cell populations, and allow immune system function to return to normal.  Patients may then enjoy a normal life without further daily treatment, until an episode occurs which mobilizes the “sleeping” cells containing the HIV genome in addition to eliminating HIV particles. Such a therapy would be called a “functional cure” against HIV. A total cure of HIV would require elimination of the dormant cell pool containing the HIV genome. Research in the field of reactivating the dormant pool of HIV infected cells is encouraging. If these cells can be reactivated, and simultaneously the HIV viremia controlled, researchers have proposed that this could lead to reduction in the dormant infected cell pool. If their hypotheses are correct, HIVCide could lead to an eventual cure, possibly in combination with other drugs.

Nanoviricides act by a different mechanism than other approved anti-HIV therapeutics. The Company believes, therefore, that by combining a nanoviricide with current therapy, a functional cure of HIV may be already achievable. However, there is no way to predict whether such a treatment would be successful at providing a functional cure of HIV at present.

Additional studies in cell cultures are planned to be conducted in the next six months. We have executed a Master Service Agreement (MSA) with Southern Research Institute, Infectious Diseases Division, Frederick, MD (SRI-F) to conduct these studies. SRI-F is a well established Contract Research Organization (CRO) that has developed, conducted, and published in scientific journals on standardized study protocols for various mechanisms of anti-HIV action, including microbicides, antibodies, and small chemical therapeutics. We are also planning additional animal studies of these drug candidates.  We are also planning additional animal model studies of the HIVCide lead drug candidate.

HIVCide is expected to be a significant anti-HIV candidate, acting by a novel mechanism of action and a first-in-class therapeutic, based on current preliminary data.  We intend to develop it further.

Herpes “Cold Sores” and Genital Herpes

We have developed nanoviricide drug candidates that are capable of attacking the herpes virus that causes cold sores and genital herpes. These drug candidates are designed so that they can be easily formulated as a skin cream or gel formulation in order to be able to apply readily to cold sores or genital lesions caused by herpes.

We have successfully tested these drug candidates in a cell culture model for effectiveness against Herpes Simplex Virus (HSV-1) infection.  This testing was conducted by TheVac, LLC laboratories at the Louisiana Emerging Technology Center located within the Louisiana State University (LSU) campus in collaboration with the LSU School of Veterinary Medicine.


Four different nanoviricides showed greater than 10,000-fold (>99.99% or 4-logs) reduction in virus quantity compared to untreated controls in a cell culture assay employing the LSU proprietary green-fluorescent-protein-tagged (GFP) modified HSV-1 McKrae strain.

These nanoviricide drug candidates are designed to act against all herpes simplex virus strains, including HSV-1 and HSV-2. The Company has commissioned additional in vitro studies to confirm the results. Animal studies have also been scheduled.

Herpes simplex virus (HSV) causes “cold sores” or “fever blisters”, the incidence of which is second only to the common cold (100 million recurrences annually in the US alone). In addition, genital herpes prevalence is 67 million infected individuals in the US alone. This represents 20% of the US population infected with symptomatic, recurrent disease. It is also believed that a large fraction of infected individuals remain asymptomatic. Seroprevalence (people with antibodies) in general French population is about 67% for HSV-1 and 17% for HSV-2. It is estimated that worldwide incidence and infection rates are very similar to these high proportions of infection prevalence.

Existing therapies for herpes virus infections include acyclovir and drugs chemically related to it (e.g. gancyclovir, valcyclovir, others). These drugs, nucleoside analogs, act by inhibiting viral DNA synthesis. However, there is known drug toxicity due to interference with human metabolism. Currently, there is no cure for herpes infection.

Nanoviricides are designed to act by a novel and distinctly different mechanism compared to existing drugs. Nanoviricides are designed to mimic the human cell surface to which the virus binds. Our results suggest that a nanoviricide could become a highly sought after drug against HSV.


Neglected Tropical Diseases and Biosecurity/Biodefense Programs

Ebola, Marburg, Dengue

We have obtained significant positive results against Ebola, although the Ebola virus produces a soluble glycoprotein decoy that may be capable of avoiding certain of our virus-binding ligands.
 
In the absence of public funding, the Company’s ability to develop these drugs is very limited. This is a low-priority project for the Company.

 
Dengue

We are currently working on developing anti-Dengue therapeutics. Dengue is an important NTD.  According to the Centers for Disease Control and Prevention in Atlanta (CDC), dengue fever risk is about 1 illness per 1,000 US travelers, and it is the most common cause of fever in returned travelers from the Caribbean, Central America, and South Central Asia. The CDC has also noted "dengue is the most important mosquito-borne viral disease affecting humans.  Each year, tens of millions of cases of DF occur and, depending on the year, up to hundreds of thousands of cases of Dengue hemorrhagic fever (DHF)." Dengue fever is also called “break-bone fever”. The first or primary dengue infection has very low fatality rates associated with it. However, when a person is infected with a different type of dengue virus afterwards, the person is at risk of developing Dengue Hemorrhagic Fever (DHF), or Severe Dengue fever. The fatality rate associated with DHF/Severe Dengue may be as high as 10%. There is currently no vaccine or cure for dengue, which causes high fever, muscular pain, headaches, vomiting, and in some cases skin rash. WHO estimates that 2.5 billion people are at risk of dengue fever or of DHF out of a total world population of 6.6 billion. Dengue viruses are carried by Aedes aegypti mosquito, which is gaining ground northwards as the global climate warms up. There have been several cases of Dengue in the southern regions of the USA.

Dengue and dengue hemorrhagic fever/dengue shock syndrome are emerging as serious global health problems. Dengue is endemic in large parts of the world. It now threatens over 3 billion people world-wide or 40% of world population, and is considered a re-emerging threat in the United States. Dengue is officially considered a “neglected tropical disease” by the World Health Organization. About 50-100 million people are infected by dengue virus every year. In fact, just recently, the government of Cali, Columbia declared a dengue emergency because of the number of dengue infections and deaths. Globalization and warming climates along with changes in the ecology of the virus-carrying mosquito are accelerating the spread of the virus. Without proper treatment, DHF fatality rates can exceed 20%. ( Source: WHO Dengue and dengue haemorrhagic fever Fact Sheet No. 117, March 2009 ; http://www.who.int/mediacentre/factsheets/fs117/en/ )


The Company signed a Research and Development agreement with Professor Eva Harris’ Lab at the University of California  Berkeley for nanoviricides against dengue viruses. Dr. Eva Harris is a Professor of Infectious Diseases at UC Berkeley. She is a leading researcher in the field of dengue. Her group has developed a unique animal model for dengue virus infection and disease  that effectively emulates the pathology seen in humans. In particular, the critical problem of dengue virus infection, called “Antibody-Dependent Enhancement” (ADE), is reproduced in this animal model. When a person who was previously infected with one serotype of dengue virus is later infected by a different serotype, the antibodies produced by the immune system can lead to increased severity of the second dengue infection, instead of controlling it. ADE thus can lead to severe dengue disease or dengue hemorrhagic fever (DHF).

The Company has developed a library of small chemical ligands that bind to dengue virus envelope proteins using in silico studies. Using these ligands, a number of candidate nanoviricides that are capable of attacking the dengue virus have been developed. The Company believes that these nanoviricide drug candidates mimic the natural, common attachment function by which the four different dengue virus serotypes bind to the body’s host cells. If this proves to be correct, the Company believes that a nanoviricide drug under development can be expected to be a broad-spectrum anti-dengue antiviral treatment capable of attacking all four dengue virus serotypes and their variant strains.

Currently there are no approved vaccines for the prevention of dengue, nor drugs for treatment of dengue virus infection. The worldwide market size for an effective anti-dengue treatment may be as large as that for Hepatitis C virus treatment, or in the billions of dollars, based on current population exposure data.

Rabies

Our RabiCide program has resulted in candidates that have enabled survival of 20% to 30% of infected animals after disease has set in, using a particular animal model. Further testing is in progress in a different experimental model. We believe that if this testing succeeds, it may be the first ever therapeutic against rabies. Currently, rabies is a uniformly lethal disease with only prophylactic medications available, which are comprised of human antibodies, monoclonal antibody mixtures, and rabies vaccine virus strains. The potential market size for a rabies drug worldwide has been estimated at $300M to $500M. In absence of public funding, the Company’s ability to develop these drugs is very limited.

Advanced Technologies: ADIF Technologies

We believe that our technologies and capabilities at attacking different viruses are fairly well demonstrated. In addition, we have developed “Accurate-Drug-In-Field” or ADIF technologies that may show efficacy in treating epidemics like H5N1, SARS or Ebola by developing a targeted therapeutic in the field to prevent the spread of the disease.

ADIF technology does not require any knowledge of the molecular biology of the virus, or even its specific identification. An accurate drug, specifically targeted at the virus, can be developed in the field, from nanomicelles stockpiled beforehand. This enables a rapid response timeframe of as short as 3 weeks for initial drug doses, and potentially less than 3 months for sufficient doses to curb the spread of the virus outside the affected area. Thus ADIF technologies are applicable to novel, or engineered viruses, or emerging infections whether natural or man-made. This technology may have significant applications in the Biodefense area. We believe that this is the only technology that can enable humans to combat novel viruses before they spread disease.

We have already demonstrated the ADIF technology capabilities successfully.


The Strength of Our Drug Pipeline

Between the two ends of the spectrum of specific antivirals developed during peace-time effort, and the specific antivirals developed as a “war-like” effort (ADIF), we have also demonstrated the capability of developing broad-spectrum nanoviricides. Broad-spectrum nanoviricides are based on the validated scientific fact that a large number of virus families employ the same cell surface receptor. Our nanoviricides are designed as “cell biomimetics,” meaning that the nanoviricides “look like” a cell to the virus.  The nanoviricide carries a portion of the broad-spectrum receptor on the nanomicelle surface that the virus attaches to and is then entrapped or dismantled by the nanoviricide. Such broad-spectrum nanoviricides could be stockpiled to enable treatment of many infectious agents with very few drugs, and thus would be valuable to worldwide disease programs, and Strategic National Stockpiling efforts.

We believe that the Company has a strong, wide and deep pipeline of drugs. However, with relatively meager financial resources, the Company continues to juggle prioritization of the various programs, and program achievements. We are also working on bolstering our infrastructure with the objective of enabling us to file pre-IND applications for some of our drug candidates with the FDA. The Company has received significant interest from major pharmaceutical companies in its Viral Eye Diseases drug candidate, and HIVCide and FluCide programs to date, and we expect interest to increase in other programs as well. There is no guarantee that this interest would result in any financially lucrative co-development agreements.

All of our programs are currently at the pre-clinical stage. We have established preliminary proof of efficacy in cell culture and animal models, and we have conducted preliminary safety studies that have indicated that all of our nanoviricides are safe in the animal models as tested.  We continue to work on further experiments necessary for development of our various drug candidates as FDA approvable drugs.

Last year, we added two commercially important drug candidates to our pipeline, namely HIVCide and EKCCide.

This year, we have greatly expanded the scope of our eye anti-viral treatment to develop drug candidate eye drops against potentially all viruses infecting the exterior portion of the eye. Our EKCCide program has now evolved into the broad-spectrum eye drops antiviral program, which is expected to lead to a significant expansion in marketability as well as market size if successful.

A nanoviricide against Herpes cold sores and genital herpes is a new addition to our pipeline of drug candidates this year. The market size for herpes simplex virus treatments is in excess of $2 billion annually.

In addition, we simplified our anti-influenza drug programs because of the high efficacies of our new drug candidates into a single pan-Influenza broadly acting new FluCide. This single drug is being developed for all influenza indications including seasonal influenzas, highly pathogenic influenzas, bird flu, and novel epidemic influenzas such as the current novel H1N1/2009. We believe that this will reduce development costs significantly. This is also expected to help us gain expanded market share and easier market acceptance, including stockpiling, when a drug is approved. Emergency Use Authorization can occur under circumstances such as the current epidemic under certain conditions after an IND has been filed, prior to a full FDA approval. We are not at the stage of submitting the necessary applications to the FDA as yet.

Further we have also begun biological testing in the Dengue antivirals program. The Company has developed a library of small chemical ligands that bind to dengue virus envelope proteins using in silico studies. Using these ligands, a number of candidate nanoviricides that are capable of attacking the dengue virus have been developed. The Company believes that these nanoviricide drug candidates mimic the natural, common attachment function by which the four different dengue virus serotypes bind to the body’s host cells. If this proves to be correct, the Company believes that a nanoviricide drug under development can be expected to be a broad-spectrum anti-dengue antiviral treatment capable of attacking all four dengue virus serotypes and their variant strains.

We are developing nanoviricides for different routes of administration, choosing the best option based on a viral disease pathology. Thus, we are developing eye drop formulation for the viral diseases of the external eye. We are developing skin cream and gel formulations for topical application of nanoviricides against oral and genital herpes. Other drugs candidates including FluCide and HIVCide are currently being developed as injectables. We believe that it will be possible in the future to develop aerosols for influenza and nasal sprays for common colds and similar diseases. This is possible because nanoviricides have been designed so that they can be formulated in many different ways.


Liquidity and Capital Resources

Requirement for Additional Capital
 
We currently have sufficient cash reserves to achieve all of our budgeted plans through December 31, 2010, and we will need to obtain additional financing to finance studies necessary for an investigational new drug (“IND”) filing with the FDA.

As of December 31, 2009 we had a cash and cash equivalent balance of $4,032,863 which can support operations through December 31, 2010, at our current projected rate of spending.

However, in addition to current funds allocated to capital costs and staffing, and in accordance with our business plan, we have also budgeted for additional capital costs and staffing costs of approximately $2 million dollars and an additional $3 million dollars for additional scientific studies in support of an IND filing with the FDA, for the upcoming twenty-four months.  If we are unable to obtain this additional financing, our business plan will be delayed.

We anticipate that we will incur the following expenses over the next twelve months:

1           Research and Development subcontractor costs of $1,500,000: Including planned costs of $1,200,000 for in-vivo and in-vitro studies for pan-influenza FluCide,  NanoViricide eye drops against EKC and other Ocular viral deceases, HIVCide, and NanoViricides against genital and ocular Herpes, planned for the next twelve months ending December 31, 2010. The Company has allocated the planned costs of $1,200,000 evenly over the four drug candidates.

2           Corporate overhead of $750,000: This amount includes budgeted office salaries, legal, accounting and other costs expected to be incurred by being a public reporting company.

3           Capital costs of $250,000: This is the estimated cost for equipment and laboratory improvements expected during the next twelve months ending December 31, 2010.

4           Staffing costs of $1,000,000: This is the estimated cost of hiring additional scientific staff and consulting firms to assist with FDA compliance, material characterization, pharmaco-kinetic, pharmaco-dynamic and toxicology studies, and other items related to FDA compliance, as required for development of necessary data for filing an Investigational New Drug Application (IND) with the United States Food and Drug Administration.

The Company will be unable to proceed with its planned drug development progress, meet its administrative expense requirements, capital costs, and staffing costs after about December 31, 2010 without obtaining additional financing of approximately $3,000,000 to $5,000,000.  If we are unable to obtain additional financing, our business plan will be significantly delayed or curtailed.  The Company continues to re-prioritize its objectives and delay certain drug development programs until we can raise sufficient funding that enables further development of the drugs with the goal of filing an Investigational New Drug application (IND) to the FDA.

The Company does not have any arrangements in place, at this time, for equity or other financing for these further needs of $3-5 million beyond minimum operations.  However, the Company is in discussions with certain investors who would provide such capital.  If we are unable to obtain additional financing, our business plan will be significantly delayed.

The Company has limited experience with pharmaceutical drug development. Thus, our budget estimates are not based on experience, but rather based on advice given by our associates and consultants. As such these budget estimates may not be accurate. In addition, the actual work to be performed is not known at this time, other than a broad outline, as is normal with any scientific work. As further work is performed, additional work may become necessary or change in plans or workload may occur. Such changes may have an adverse impact on our estimated budget. Such changes may also have an adverse impact on our projected timeline of drug development.


We believe that this coming year's work-plan will lead us to obtain certain information about the safety and efficacy of some of the drugs under development in animal models. If our studies are not successful, we will have to develop additional drug candidates and perform further studies. If our studies are successful, then we expect to be able to undertake further studies in animal models to obtain necessary data regarding the pharmaco-kinetic and pharmaco-dynamic profiles of our drug candidates. We believe these data will then enable us to file an Investigational New Drug (IND) application, towards the goal of obtaining FDA approval for testing the drugs in human patients.

Most pharmaceutical companies expect 4 to 10 years of study to be required before a drug candidate reaches the IND stage. We believe that because we are working in the infectious agents area, our studies will have objective response end points, and will be of relatively short durations. Our business plan is based on these assumptions. If we find that we have underestimated the time duration of our studies, or we have to undertake additional studies, due to various reasons within or outside of our control, this will grossly and adversely impact both our timelines and our financing requirements.

Management intends to use capital and debt financing, as required, to fund the Company’s operations. There can be no assurance that the Company will be able to obtain the additional capital resources necessary to fund its anticipated obligations for the next twelve months.

The Company is considered to be a development stage company and will continue in the development stage until it generates revenues from the sales of its products or services.


IT EM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

The Company is not exposed to market risk related to interest rates or foreign currencies.


IT EM 4.  CONTROLS AND PROCEDURES

(a)          Evluation of disclosure controls and procedures.

Based upon an evaluation of the effectiveness of disclosure controls and procedures, our Chief Executive Officer ("CEO") and Chief Financial Officer ("CFO") have concluded that as of the end of the period covered by this Quarterly Report on Form 10-Q our disclosure controls and procedures (as defined in Rules 13a-15(e) or 15d-15(e) under the Exchange Act) were effective to provide reasonable assurance that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified by the rules and forms of the SEC and is accumulated and communicated to management, including the CEO and CFO, as appropriate to allow timely decisions regarding required disclosure.

b)           Changes in internal control over financial reporting.

Other than as described above, there were no material changes in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) that occurred as of December 31, 2009, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.


PART II. OTHER INFORMATION

ITEM 1.    LEGAL PROCEEDINGS

None.


ITEM 2.    UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

In August 2009, members of the Company’s Scientific Advisory Board (SAB) were granted warrants to purchase 50,000 shares of common stock at $1.10 per share. These warrants, if not exercised, will expire in August, 20133.

On September 30, 2009, the Company accepted subscriptions from certain investors in the aggregate amount of $3,217,400 from the offerings of shares of the Company’s common stock and warrants to purchase common stock and the exercise by the Company’s warrantholders of their outstanding warrants.  The offerings were commenced in June 2009, when the Company’s stock price levels were approximately $0.57.  The offerings were closed to investors on August 30, 2009, after an extension by the Company’s Board of Directors from the original termination date of August 14, 2009.  In the Company’s offering of Units comprised of shares of common stock and warrants to purchase common stock, the Company accepted subscriptions for $1,337,500 for Units consisting of 2,675,000 shares and Warrants to purchase an additional 1,337,500 shares.  In the offering to its warrantholders, the Company raised an aggregate of $1,879,900 for 3,759,800 shares and warrants to purchase 3,759,800 shares.  All of the warrants sold in the offerings are exercisable at the price of $1.00 per share and expire in three years.
 
On October 26, 2009, the Company granted warrants to purchase 5,250 shares of common stock at $1.00 per share for services rendered.  The Company recorded an expense of $3,750.
 
In November 2009, the Scientific Advisory Board (SAB) was granted warrants to purchase 50,000 shares of common stock at $1.06 per share. These warrants, if not exercised, will expire in November, 2013.
 
On November 11, 2009, 10,000 warrants issued to a member of the Scientific Advisory Board (SAB) were converted into common stock, resulting in the issuance of 10,000 common shares.  The Company received $1,440 upon this conversion.
 
On November 25, 2009, the Company authorized the issuance of 32,500 shares of common stock with a restrictive legend in payment of a current account payable for laboratory equipment in the amount of $25,200.
 
For the six months ended December 31, 2009, the Company's Board of Directors authorized the issuance of additional 93,530 shares of its common stock with a restrictive legend, for consulting and legal services. The Company recorded an expense of$64,463.
 
All of the securities set forth above were issued by the Company pursuant to Section 4(2) of the Securities Act of 1933, as amended, or the provisions of Rule 504 of Regulation D promulgated under the Securities Act. All such shares issued contained a restrictive legend and the holders confirmed that they were acquiring the shares for investment and without intent to distribute the shares. All of the purchasers were friends or business associates of the Company’s Management and all were experienced in making speculative investments, understood the risks associated with investments, and could afford a loss of the entire investment. The Company has never utilized an underwriter for an offering of its securities.

IT EM 3.  DEFAULTS UPON SENIOR SECURITIES

None.

IT EM 4.  SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

None.

IT EM 5.  OTHER INFORMATION

On February 15, 2010, the Company’s Board of Directors approved the Company’s Amended By-Laws to be effective as of February 15, 2010.


On February 8, 2010, the Company announced that it signed a research and development agreement with Dr. Eva Harris’s laboratory at the University of California, Berkeley (UC Berkeley ).   Pursuant to the terms of this agreement, Dr. Harris and UC Berkley will evaluate the effectiveness of nanoviricides drug candidates against various dengue viruses. Cell cultures models as well as in vivo animal studies will be employed for testing the drug candidates.  Dr. Eva Harris is a Professor of Infectious Diseases at UC Berkeley and a leading researcher in the field of dengue.

On February 15, 2010 the Company approved an Additional License Agreement with TheraCour Pharma, Inc. (“TheraCour”).  Pursuant to the exclusive Additional License Agreement, the Company was granted exclusive licenses, in perpetuity, for technologies, developed by TheraCour, for  the development of drug candidates for the treatment of  Dengue viruses, Ebola/Marburg viruses, Japanese Encephalitis, viruses causing viral Conjunctivitis (a disease of the eye) and Ocular Herpes.  As consideration for obtaining these exclusive licenses, we agreed to pay a one time licensing fee equal to seven million shares of the Company’s Series A Convertible Preferred Stock (the “Series A Preferred Stock”).  The Series A Preferred Stock is convertible, only upon sale or merger of the company, or the sale of or license of substantially all of the Company’s intellectual property, into shares of the Company’s common stock at the rate of four shares of common stock for each share of Series A Preferred Stock.  The Series A Preferred Stock has a preferred voting preference at the rate of four votes per share.  In addition, the Company agreed: (i) to the extent not paid under the existing license agreement, TheraCour can charge its costs (direct and indirect) plus no more than 30% of direct costs as a development fee which shall be due and payable in periodic installments as billed; (ii) to the extent not paid under the existing license agreement, TheraCour can charge a development fee of  $25,000 per month for usage of lab supplies and chemicals from TheraCour’s existing stock ; (iii) the Company will pay TheraCour the amount of $2,000 or actual costs, whichever is greater, for other general and administrative expenses incurred by TheraCour on its behalf; (iv) the Company make royalty payments (calculated as a percentage of net sales of the licensed drugs) of 15% to TheraCour; (5) TheraCour shall retain the exclusive right to develop and manufacture the licensed drugs; and (vi) TheraCour may request the Company to pay an advance payment (refundable) equal to twice the amount of the previous months invoice to be applied as a prepayment towards expenses. The Company does not anticipate any material increase in direct payments for development fees or for general and administrative expenses, to TheraCour, as a result of this Additional License Agreement.

IT EM 6.  EXHIBITS AND REPORTS ON FORM 8-K

(a)    Exhibit index
 
 
Exhibit
 
 
     
 
Amended By-Laws
     
 
Certificate of Designation of Rights and Preferences of Series A Convertible Preferred Stock
     
 
Additional License Agreement between NanoViricides, Inc. and TheraCour Pharma, Inc.
     
 
Certification of Chief Executive and Interim Chief Financial Officer required by Rule 13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act of 1934, as amended.
     
 
Certification of Chief Executive Officer and Interim Chief Financial Officer  required by Rule 13a-14(b) or Rule 15d-14(b) under the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.


(b)    Reports on Form 8-K.  During the fiscal quarter ended December 31, 2009, the Company filed the following Current Reports on Form 8-K:


On October 5, 2009, the Company filed a Current Report disclosing that it had accepted subscriptions from certain investors in the aggregate amount of $3,217,400 from the offerings of shares of the Company’s common stock and warrants to purchase common stock and the exercise by the Company’s warrant holders of their outstanding warrants.  In the Company’s offering of Units comprised of shares of common stock and warrants to purchase common stock, the Company accepted subscriptions for $1,337,500 for Units consisting of 2,675,000 shares and Warrants to purchase an additional 1,337,500 shares.  In the offering to its warrant holders, the Company raised an aggregate of $1,879,900 for 3,759,800 shares and warrants to purchase 3,759,800 shares.
 
Additionally, the Company amended its disclosures previously reported in its Current Report on Form 8-K filed on July 10, 2009, to reflect that the Company accepted subscriptions from its warrant holders for an aggregate of $1,025,350 (revised downward from $1,050,350) for 2,050,700 shares of common stock and warrants to purchase 2,050,700 shares of common stock (revised downward from 2,100,700 shares and warrants).  The Company also reported that in a separate offering which also closed on July 7, 2009, the Company accepted subscriptions of $75,000 for 150,000 shares of common stock and warrants to purchase an additional 75,000 shares.


SI GNATURES
 
Pursuant to the requirements of Section 13 or 15(d) 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.
 
Dated: February 22, 2010
 
NANOVIRICIDES, INC.
/s/ Eugene Seymour, MD
 
Eugene Seymour, M.D.
Chief Executive Officer and Interim Chief Financial Officer and Director
(Principal Executive and Financial Officer)
 

/s/ Anil Diwan
 
Anil Diwan,
President and Chairman of the Board of Directors
 
 
30


Exhibit 3.1
 
AMENDED AND RESTATED BY-LAWS
 
OF
 
NANOVIRICIDES, INC.
 
A Nevada corporation
(the "Corporation")


ARTICLE I
OFFICES

Offices . The registered office of the Corporation is located in the city and state designed by the Corporation in its Articles of Incorporation.  The Corporation may also maintain offices at such other places both within and without the State of Nevada as the Board of Directors may from time to time determine or the business of the Corporation may require.

ARTICLE II
MEETINGS OF STOCKHOLDERS

SECTION 1.    Annual Meetings .  A meeting of the stockholders for the purpose of electing directors and for the transaction of such other business as may properly be brought before the meeting shall be held annually at 10 A.M. on November 1, or at such other time on such other day as shall be fixed by resolution of the Board of Directors.  If the day fixed for the annual meeting shall be a legal holiday, such meeting shall be held on the next succeeding business day.

SECTION 2 .   Special Meetings . Special meetings of the stockholders for any purpose or purposes may be called at any time by a majority of the Board of Directors, by the Chairman of the Board, or by the President and shall be called by the Secretary at the request of the holders of not less than fifty-one percent of all issued and outstanding shares of the Corporation entitled to vote at the meeting.

SECTION 3 . Place of Meetings .  The annual meeting of the stockholders of the Corporation shall be held at the general offices of the Corporation in the City of West Haven, Connecticut, or at such other place in the United States as may be stated in the notice of the meeting.  All other meetings of the stockholders shall be held at such places within or without the State of Nevada as shall be stated in the notice of the meeting.

SECTION 4.    Notice of Meetings .  Except as otherwise provided by law, written notice of each meeting of the stockholders, whether annual or special, shall be given not less than 10 nor more than 60 days before the date of the meeting to each stockholder entitled to vote at such meeting.  If mailed, notice shall be given when deposited in the United States mails, postage prepaid, directed to such stockholder at his address as it appears in the stock ledger of the Corporation.  Each such notice shall state the place, date and hour of the meeting, and, in the case of a special meeting, the purpose or purposes for which the meeting is called.

 
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When a meeting is adjourned to another time and place, notice of the adjourned meeting need not be given if the time and place thereof are announced at the meeting at which the adjournment is given.  If the adjournment is for more than thirty days, or if after the adjournment a new record date is fixed for the adjourned meeting, a notice of the adjourned meeting shall be given to each stockholder of record entitled to vote at the meeting.

SECTION 5 .   Quorum .  At any meeting of the stockholders the holders of record of a majority of the total number of outstanding shares of stock of the Corporation entitled to vote at the meeting, present in person or represented by proxy, shall constitute a quorum for all purposes, provided that at any meeting at which the holders of any series of class of stock shall be entitled, voting as a class, to elect  Directors, the holders of record of a majority of the total number of outstanding shares of such series or class, present in person or represented by proxy, shall constitute a quorum for the purpose of such election.

In the absence of a quorum at any meeting, the holders of a majority of the shares of stock entitled to vote at the meeting, present in person or represented by proxy at the meeting, may adjourn the meeting, from time to time, until the holders of the number of shares requisite to constitute a quorum shall be present in person or represented at the meeting.  At any adjourned meeting at which a quorum is present, any business may be transacted that might have been transacted at the meeting as originally convened.

SECTION 6.    Organization .  At each meeting of the stockholders, the Chairman of the Board, or if he so designates or is absent, the President, shall act as Chairman of the meeting. In the absence of both the Chairman of the Board and the President, such person as shall have been designated by the Board of Directors, or in the absence of such designation a person elected by the holders of a majority in number of shares of stock present in person or represented by proxy and entitled to vote at the meeting, shall act as Chairman of the meeting.

The Secretary or, in his absence, an Assistant Secretary or, in the absence of the Secretary and all of the Assistant Secretaries, any person appointed by the Chairman of the meeting shall act as Secretary of the meeting.

SECTION 7.    Voting .  Unless otherwise provided in the Articles of Incorporation or a resolution of the Board of Directors creating a series of stock, and designating the rights thereto, at each meeting of the stockholders, each holder of shares of any series or class of stock entitled to vote at such meeting shall be entitled to cast one vote for each share of stock having voting power in respect of each matter upon which a vote is to be taken, except for the casting of votes for directors which is set forth in Section 8 herein, standing in his name on the stock ledger of the Corporation on the record date fixed as provided in these Amended and Restated By-Laws for determining the stockholders entitled to vote at such meeting or, if no record date be fixed, at the close of business on the day next preceding the day on which notice of the meeting is given.  Shares of its own capital stock belonging to the Corporation, or to another Corporation if a majority of the shares entitled to vote in he election of directors of such other Corporation is held by the Corporation, shall neither be entitled to vote nor counted for quorum purposes.

 
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At all meetings of stockholders for the election of Directors the voting shall be by ballot, and the persons having the greatest number of votes shall be deemed and declared elected. All other elections and questions submitted to a vote of the stockholders shall, unless otherwise provided by law or the Articles of Incorporation, be decided by the affirmative vote of the majority of shares which are present in person or represented by proxy at the meeting and entitled to vote on the subject matter.

SECTION 8 .   C umulative Voting of Directors .  Except as otherwise provided by the Board of Directors in establishing any class or series of stock with respect to such class or series, each shareholder who is entitled to vote in the election of Directors is entitled in any such election to multiply the number of votes that the shareholder would be entitled to cast for the election of Directors multiplied by the number of Directors to be elected, and to cast all of such votes for a single candidate or distribute such votes among any two or more candidates, as the shareholder sees fit.

SECTION 9 .   Inspectors .  Prior to each meeting of stockholders, the Board of Directors shall appoint two Inspectors who are not directors, candidates for directors or officers of the Corporation, who shall receive and determine the validity of proxies and the qualifications of voters, and receive, inspect, count and report to the meeting in writing the votes cast on all matters submitted to a vote at such meeting. In case of failure of the Board of Directors to make such appointments or in case of failure of any Inspector so appointed to act, the Chairman of the Board shall make such appointment or fill such vacancies.

Each Inspector, immediately before entering upon his duties, shall subscribe to an oath or affirmation faithfully to execute the duties of Inspector at such meeting with strict impartiality and according to the best of his ability.

SECTION 10 .   List of Stockholders .  The Secretary or other officer or agent having charge of the stock ledger of the Corporation shall prepare and make, at least ten days before every meeting of stockholders, a complete list of the stockholders entitled to vote at said meeting, arranged in alphabetical order and showing the address of each stockholder and the number of shares of each class and series registered in the name of each such stockholder.  Such list shall be open to the examination of any stockholder, for any purpose germane to the meeting, at the time and place of the meeting during the whole time thereof and may be inspected by any stockholder who is present.

SECTION 11 .   Business at Meetings of Stockholders .

(a)  General.  The business to be conducted at any meeting of stockholders of the Corporation shall be limited to such business and nominations as shall comply with the procedures set forth in this Article and Article XII of these Amended and Restated By-laws.

 
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(b)  Notification of Stockholder Business.  At any special meeting of stockholders only such business shall be conducted as shall have been brought before the meeting pursuant to the Corporation’s notice of special meeting. At an annual meeting of stockholders, only such business shall be conducted as shall have been properly brought before the meeting. To be properly brought before an annual meeting, business must be either (i) specified in the notice of meeting (or any supplement thereto) given by or at the direction of the Board of Directors, including matters included pursuant to Rule 14a-8 of the Securities and Exchange Commission, (ii) otherwise (a) properly requested to be brought before the meeting by a stockholder of record entitled to vote in the elections of directors generally, and (b) constitute a proper subject to be brought before the meeting. In addition to any other applicable requirements, for business (other than the election of directors) to be otherwise properly brought before an annual meeting by a stockholder, the business must be a proper matter for stockholder action and the stockholder must have given timely notice thereof in writing to the Secretary of the Corporation. To be timely, a stockholder's notice must be addressed to and received at the principal executive offices of the Corporation, not more than 150 days and not less than 120 days prior to the first anniversary of the preceding year's annual meeting; provided, however, that in the event that the date of the meeting is more than 30 days before or after such anniversary date, notice by the stockholder to be timely must be so received not later than the close of business on the 15th day following the day on which notice of the date of the annual meeting was mailed or public disclosure was made, whichever first occurs. A stockholder's notice to the Secretary shall set forth as to each matter (other than the election of directors) the stockholder proposes to bring before the annual meeting (i) a brief description of the business desired to be brought before the annual meeting and the reasons for conducting such business at the annual meeting, (ii) the name and record address of the stockholder proposing such business and of each beneficial owner on behalf of which the stockholder is acting, (iii) the class and number of shares of the Corporation which are beneficially owned by the stockholder and by any such beneficial owner, (iv) a representation that the stockholder is a holder of record of capital stock of the Corporation entitled to vote at such meeting and intends to appear in person or by proxy at the meeting to present such business, (v) any material interest of the stockholder and of any such beneficial owner in such business; and (vi) whether the proponent intends or is part of a group which intends to solicit proxies from other stockholders in support of such proposal.

Notwithstanding anything in these Amended and Restated By-Laws to the contrary, no business shall be conducted at an annual meeting except in accordance with the procedures set forth in this Section 10 of Article II, provided, however, that nothing in this Section 10 of Article II shall be deemed to preclude discussion by any stockholder of any business properly brought before the annual meeting.

The Chairman of an annual or special meeting shall have the power and duty to determine and shall, if the facts warrant, determine and declare to the meeting that business was not properly brought before the meeting in accordance with the provisions of this Section 10 of Article II, and if he should so determine, he shall so declare to the meeting and any such business not properly brought before the meeting shall not be transacted.

ARTICLE III
BOARD OF DIRECTORS

SECTION 1.    Number, Qualification and Term of Office .  The business, property and affairs of the Corporation shall be managed by a Board consisting of not less than two nor more than seven Directors.  The Board of Directors shall from time to time by a vote of a majority of the Directors then in office fix within the maximum and minimum limits the number of Directors to constitute the Board.  Directors shall be elected at the annual meeting of stockholders, or at a special meeting called for that purpose as provided in these Amended and Restated By-laws, by a plurality of the votes cast at such election.  In all elections of directors, each shareholder shall be entitled to as many votes as shall equal the number of shares which such shareholder owns. Each shareholder may cast all of such votes for a single director or may distribute them among the number to be voted for, as such shareholder may see fit.  The entire number of directors to be elected at an election shall be balloted for at one time and not separately.

 
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The terms of the Directors shall be staggered in accordance with the following provisions:  subject to the special rights of the holders of any class or series of stock to elect directors, at the next election of Directors, shall be divided into three classes ; the Directors serving on the Board of Directors as of the date these Amended and Restated By-Laws are adopted by the Corporation shall be split equally among the classes  The terms of office of initial Class I directors expire at the 2012 annual meeting of shareholders; the terms of office of the initial Class II expire at the 2013 annual meeting of shareholders; and the terms of office of initial Class III directors expire at the 2014 annual meeting of shareholders. At each annual meeting of shareholders beginning with the 2013 annual meeting of shareholders following the filing of the articles of incorporation, the successors of the class of directors whose terms expire at that meeting shall be elected for a term of two years. Each director in each such class shall hold office until the director’s successor is duly elected and qualified.

SECTION 2.    Vacancies . Vacancies in the Board of Directors and newly created directorships resulting from any increase in the authorized number of Directors may be filled by a majority of the Directors of Executive Committee of the Board of Directors as set forth in Article IV Section 1 of these Amended and Restated By-Laws.

SECTION 3.    Resignations .  Any Director may resign at any time upon written notice to the Secretary of the Corporation.  Such resignation shall take effect on the date of receipt of such notice or at any later date specified therein; and the acceptance of such resignation, unless required by the terms thereof, shall not be necessary to make it effective.  When one or more Directors shall resign effective at a future date, a majority of the Directors then in office, including those who have resigned, shall have power to fill such vacancy or vacancies to take effect when such resignation or resignations shall become effective.

SECTION 4 .   Removals .  Any Director may be removed, with cause, at any special meeting of the Executive Committee of the Board of Directors as set forth in Article IV Section 1 of the Amended and Restate By-Laws, and the vacancy in the Board caused by any such removal may be filled by the Members of the Committee at such a meeting.

SECTION 5 .   Place of Meetings; Books and Records .  The Board of Directors may hold its meetings, and have an office or offices, at such place or places within or without the State of Nevada as the Board from time to time may determine.

The Board of Directors, subject to the provisions of applicable law, may authorize the books and records of the Corporation, and offices or agencies for the issue, transfer and registration of the capital stock of the Corporation, to be kept at such place or places outside of the State of Nevada as, from time to time, may be designated by the Board of Directors.

 
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SECTION 6.    Annual Meeting of the Board .  The first meeting of each newly elected Board of Directors, to be known as the Annual Meeting of the Board, for the purpose of electing officers,  designating committees and the transaction of such other business as may come before the Board, shall be held as soon as practicable after the adjournment of the annual meeting of stockholders, and no notice of such meeting shall be necessary to the newly elected Directors in order legally to constitute the meeting, provided a quorum shall be present.  In the event such meeting is not held due to the absence of a quorum, the meeting may be held at such time and place as shall be specified in a notice given as hereinafter provided for special meetings of the Board of Directors or as shall be specified in a written waiver signed by all of the newly elected Directors.

SECTION 7.    Regular Meetings .  The Board of Directors shall, by resolution, provide for regular meetings of the Board at such times and at such places as it deems desirable.  Notice of regular meetings need not be given.

SECTION 8 .   Special Meetings .  Special meetings of the Board of Directors may be called by the Chairman of the Board or the President and shall be called by the Secretary on the written request of at least two (2) Directors on such notice as the person or persons calling the meeting shall deem appropriate in the circumstances.  Notice of each such special meeting shall be mailed to each Director or delivered to him by telephone, telegraph or any other means of electronic communication, in each case addressed to his residence or usual place of business, or delivered to him in person or given to him orally.  The notice of meeting shall state the time and place of the meeting but need not state the purpose thereof.  Attendance of a Director at any meeting shall constitute a waiver of notice of such meeting except when a Director attends a meeting for the express purpose of objecting to the transaction of any business because the meeting was not lawfully called or convened. Except as provided by law, the Directors may waive notice of such meeting and consent to the action taken as set forth in Section 12 hereof.

SECTION 9 .   Quorum and Manner of Acting .  Except as otherwise provided by statute, the Articles of Incorporation or these Amended and Restated By-Laws, the presence of a majority of the total number of Directors shall constitute a quorum for the transaction of business at any regular or special meeting of the Board of Directors, and the act of a majority of the Directors present at any such meeting at which a quorum is present shall be the act of the Board of Directors.  In the absence of a quorum, a majority of the Directors present may adjourn the meeting, from time to time, until a quorum is present.  Notice of any such adjourned meeting need not be given.

SECTION  10 .   Chairman of the Board .   A Chairman of the Board shall be elected by the Board of Directors from among its members for a prescribed term and may, or may not be, at the discretion of the Board of Directors, an employee or an officer of the Corporation.  If the Chairman is neither an employee nor an officer of the Corporation he may be designated "non-executive."  The Chairman of the Board shall perform such duties as shall be prescribed by the Board of Directors and,  when present, shall preside at all meetings of the stockholders and the Board of Directors.  In the absence or disability of the Chairman of the Board, the Board of Directors shall designate a member of the Board to serve as Chairman of the Board and such designated Board Member shall have the powers and perform the duties of the office; provided, however, that if the Chairman of the Board shall so designate or shall be absent from a meeting of stockholders, the President shall preside at such meeting of stockholders.

 
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SECTION  11 .   Organization .  At every meeting of the Board of Directors, the Chairman of the Board or, in his absence the President or, if both of these individuals are absent, a Chairman chosen by a majority of the Directors present shall act as Chairman of the meeting.  The Secretary or, in his absence, an Assistant Secretary or, in the absence of the Secretary and all the Assistant Secretaries, any person appointed by the Chairman of the meeting shall act as Secretary of the meeting.

SECTION  12 .   Consent of Directors in Lieu of Meeting .  Unless otherwise restricted by the Articles of Incorporation or by these Amended and Restated By-Laws, any action required or permitted to be taken at any meeting of the Board of Directors, or any committee designated by the Board, may be taken without a meeting if a majority of members of the Board or committee consent thereto in writing, and such written consent is filed with the minutes of the proceedings of the Board or committee.

SECTION  13 .   Telephonic Meetings .  Members of the Board of Directors, or any committee designated by the Board, may participate in a meeting of the Board or committee by means of conference telephone or similar communications equipment by means of which all persons participating in the meeting can hear each other and participation in such a meeting shall constitute presence in person at such meeting.

SECTION  14 .   Compensation .  Each Director who is not a full-time salaried officer of the Corporation or any of its wholly owned subsidiaries, when authorized by resolution of the Board of Directors may receive as a Director a stated salary or an annual retainer and in addition may be allowed a fixed fee and his reasonable expenses for attendance at each regular or special meeting of the Board or any Committee thereof.


ARTICLE IV
COMMITTEES OF THE BOARD OF DIRECTORS

SECTION 1 .   Executive Committee . The Board of Directors may, in its discretion, designate annually an Executive Committee.  The Committee shall consist of two (2) or more members who shall serve at the pleasure of the Board of Directors.  The Committee shall have and may exercise all the powers and authority of the Board of Directors in the management of the business and affairs of the Corporation, including, but not limited to, appointing and removing the Directors and officers of the Corporation and evaluating and approving financing proposals and securities offerings, and may authorize the seal of the Corporation to be affixed to all papers which may require it, but the Committee shall have no power or authority to amend the Articles of Incorporation, adopt an agreement of merger or consolidation, recommend to the stockholders the sale, lease or exchange of all or substantially all of the Corporation's property and assets, recommend to the stockholders a dissolution of the Corporation or a revocation of a dissolution, amend the Amended and Restated By-Laws of the Corporation, declare a dividend, authorize the issuance of stock, or such other powers as the Board may from time to time eliminate.

 
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SECTION 2 .   Audit Committee .  The Board of Directors may, in its discretion, designate annually an Audit Committee to assist the Board in fulfilling its responsibilities with respect to overseeing the accounting, auditing and financial reporting practices and the internal control policies and procedures of the Corporation.  If so designated, the Board shall adopt a charter for the Audit Committee, and the Audit Committee shall review and assess the adequacy of the charter on an annual basis.  The duties of the Audit Committee, which shall be set forth in its charter shall be to: (i) be directly responsible for the appointment, compensation, retention and oversight of the work of any registered public accounting firm engaged for the purpose of preparing or issuing an audit report or performing other audit, review or attest services for the issuer; (ii) establish procedures for the receipt, retention and treatment of complaints regarding accounting, internal accounting controls or auditing matters, including procedures for the confidential, anonymous submission by employees of the issuer of concerns regarding questionable accounting or auditing matters; and (iii) engage independent counsel and other advisors, as it determines necessary to carry out its duties as set forth herein.

All members of the Audit Committee shall meet the requirements of the charter and any relevant regulatory body, as interpreted by the Board in its reasonable business judgment.  The Corporation shall provide funding requested by the Audit Committee as it reasonably relates to carry out its duties set forth herein.  The Board shall elect or appoint a chairman of the Audit Committee who will have authority to act on behalf of the committee between meetings.  The Chairman may appoint a temporary Chairman in his or her absence.

SECTION 3 .   Code of Ethics Committee .  The Board of Directors may, in its discretion, designate annually a Code of Ethics Committee to assist the Board in adopting a Code of Ethics for its senior financial offices reasonably necessary to promote:

(a)  honest and ethical conduct; including the ethical handling of actual or apparent conflicts of interest between personal and professional relationships;

(b)  full, fair, accurate, timely and understandable disclosure in the periodic reports required to be filed by the Corporation; and

(c)  compliance with applicable governmental rules and regulations.

SECTION 4 .   Committee Chairman, Books and Records .  Unless designated by the Board of Director, each Committee shall elect a Chairman to serve for such term as it may determine.  Each committee shall fix its own rules of procedure and shall meet at such times and places and upon such call or notice as shall be provided by such rules.  It shall keep a record of its acts and proceedings, and all action of the Committee shall be reported to the Board of Directors at the next meeting of the Board.

 
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SECTION 5 .   Alternates .   Alternate members of the Committees prescribed by this Article IV may be designated by the Board of Directors from among the Directors to serve as occasion may require.  Whenever a quorum cannot be secured for any meeting of any such Committees from among the regular members thereof and designated alternates, the member or members of such Committee present at such meeting and not disqualified from voting, whether or not he or they constitute a quorum, may unanimously appoint another member of the Board to act at the meeting in the place of such absent or disqualified member.

Alternate members of such Committees shall receive a reimbursement for expenses and compensation at the same rate as regular members of such Committees.

SECTION 6 .   Other Committees .  The Board of Directors may designate such other Committees,  as it may from time to time determine, and each such Committee shall serve for such term and shall have and may exercise, during intervals between meetings of the Board of Directors, such duties, functions and powers as the Board of Directors may from time to time prescribe.

SECTION 7 .   Quorum and Manner of Acting .  At each meeting of any Committee the presence of a majority of the members of such Committee, whether regular or alternate, shall be necessary to constitute a quorum for the transaction of business, and if a quorum is present the concurrence of a majority of those present shall be necessary for the taking of any action.


ARTICLE V
OFFICERS

SECTION 1 .   Number .  The officers of the Corporation shall be a President, Secretary, and Treasurer, each of which officers shall be elected by the Board of Directors, and such other officers as the Board of Directors may determine, in its discretion, to elect.  Any number of offices may be held by the same person.  Any officer may hold such additional title descriptions or qualifiers such as "Chief Executive Officer", "Chief Operating Officer", “Chief Financial Officer”, "Senior Vice President", "Executive Vice President" or "Assistant Secretary" or such other title as the Board of Directors shall determine.

SECTION 2 .   Election, Term of Office and Qualifications .  The officers of the Corporation shall be elected annually by the Board of Directors.  Each officer elected by the Board of Directors shall hold office until his successor shall have been duly elected and qualified, or until he shall have died, resigned or been removed in the manner hereinafter provided.
SECTION 3 .   Resignations.    Any officer may resign at any time upon written notice to the Secretary of the Corporation.  Such resignation shall take effect at the date of its receipt, or at any later date specified therein; and the acceptance of such resignation, unless required by the terms thereof, shall not be necessary to make it effective.

SECTION 4 .   Removals .  Any officer elected or appointed by the Board of Directors may be removed, with or without cause, by the Board of Directors at a regular meeting or special meeting of the Board.  Any officer or agent appointed by any officer or committee may be removed, either with or without cause, by such appointing officer or committee.

 
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SECTION 5 .   Vacancies .  Any vacancy occurring in any office of the Corporation shall be filled for the unexpired portion of the term in the same manner as prescribed in these Amended and Restated By-Laws for regular election or appointment to such office.

SECTION 6 .   Compensation of Officers .  The compensation of all officers elected by the Board of Directors shall be approved or authorized by the Board of Directors or by the President when so authorized by the Board of Directors or these Amended and Restated By-Laws.

SECTION 7 .   Absence or Disability of Officers .  In the absence or disability of the Chairman of the Board or the President, the Board of Directors may designate, by resolution, individuals to perform the duties of those absent or disabled.  The Board of Directors may also delegate this power to a committee or to a senior corporate officer.

ARTICLE VI
STOCK CERTIFICATES AND TRANSFER THEREOF

SECTION 1 .   Stock Certificates .  Except as otherwise permitted by  law, the Articles of Incorporation or resolution or resolutions of the Board of Directors, every holder of stock in the Corporation shall be entitled to have a certificate, signed by or in the name of the Corporation by the Chairman of the Board, the President or a Vice President, and by the Treasurer or an Assistant Treasurer, or the Secretary or an Assistant Secretary of the Corporation, certifying the number of shares, and the class and series thereof, owned by him in the Corporation.  Any and all of the signatures on the certificate may be a facsimile.  In case any officer, transfer agent or registrar who has signed or whose facsimile signature has been placed upon a certificate shall have ceased to be such officer, transfer agent or registrar before such certificate is issued, it may be issued by the Corporation with the same effect as if he were such officer, transfer agent or registrar at the date of issue.

SECTION 2 .   Transfer of Stock .  Transfer of shares of the capital stock of the Corporation shall be made only on the books of the Corporation by the holder thereof, or by his attorney thereunto duty authorized, and on surrender of the certificate or certificates for such shares.  A person in whose name shares of stock stand on the books of the Corporation shall be deemed the owner thereof as regards the Corporation, and the Corporation shall not, except as expressly required by statute, be bound to recognize any equitable or other claim to, or interest in, such shares on the part of any other person whether or not it shall have express or other notice thereof.

SECTION 3 .   Lost, Destroyed or Mutilated Certificates .   The Board of Directors may provide for the issuance of new certificates of stock to replace certificates of stock lost, stolen, mutilated or destroyed, or alleged to be lost, stolen, mutilated or destroyed, upon such terms and in accordance with such procedures as the Board of Directors shall deem proper and prescribe.

 
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SECTION 4 .   Record Date .  In order that the Corporation may determine the stockholders entitled to notice of or to vote at any meeting of stockholders or any adjournment thereof, or entitled to receive payment of any dividend or other distribution or allotment of any rights, or entitled to exercise any rights in respect of any change, conversion or exchange of stock or for the purpose of any other lawful action, the Board of Directors may fix, in advance, a record date, which shall not be more than sixty nor less than ten days before the date of such meeting, nor more than sixty days prior to any other action.  A determination of stockholders of record entitled to notice of or to vote at a meeting of stockholders shall apply to any adjournment of the meeting; provided, however, that the Board of Directors may fix a new record date for the adjourned meeting.


ARTICLE VII
DIVIDENDS, SURPLUS, ETC.

Except as otherwise provided by statute or the Articles of Incorporation, the Board of Directors may declare dividends upon the shares of its capital stock either (1) out of its surplus, or (2) in case there shall be no surplus, out of its net profits for the fiscal year, whenever, and in such amounts as, in its opinion, the condition of the affairs of the Corporation shall render it advisable.  Dividends may be paid in cash, in property or in shares of the capital stock of the Corporation.


ARTICLE VIII
SEAL

The corporate seal shall have the name of the Corporation inscribed thereon and shall be in such form as may be approved from time to time by the Board of Directors.  The seal may be used by causing it or a facsimile thereof to be impressed or affixed or in any other manner reproduced.


ARTICLE IX
FISCAL YEAR

The fiscal year of the Corporation shall begin on the first day of July of each year.

 
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ARTICLE X
INDEMNIFICATION

SECTION 1 .   Right to Indemnification .   Each person who was or is made a party or is threatened to be made a party to or is involved (including, without limitation, as a witness) in any actual or threatened action, suit or proceeding, whether civil, criminal, administrative or investigative (hereinafter a "proceeding"), by reason of the fact that such person is or was a director of the Corporation or is or was serving at the request of the Corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise (hereinafter an "indemnitee"), whether the basis of such proceeding is alleged action in an official capacity as a director, officer, employee or agent or in any other capacity while serving as a director, officer, employee or agent,  shall be indemnified and held harmless by the Corporation to the full extent authorized by the Nevada Revised Statutes (“N.R.S.”), as the same exists or may hereafter be amended (but, in the case of any such amendment, only to the extent that such amendment permits the Corporation to provide broader indemnification rights than said law permitted the Corporation to provide prior to such amendment), or by other applicable law as then in effect, against all expense, liability and loss (including attorney's fees, judgments, fines, ERISA excise taxes or penalties and amounts to be paid in settlement) actually and reasonably incurred or suffered by such indemnitee in connection therewith and such indemnification shall continue as to an indemnitee who has ceased to be a director, officer, employee or agent and shall inure to the benefit of the indemnitee's heirs, executors and administrators, provided, however, that except as provided in Section 2 of this Article with respect to proceedings seeking to enforce rights to indemnification, the Corporation shall indemnify any such indemnitee seeking indemnification in connection with a proceeding (or part thereof) initiated by such indemnitee only if such proceeding (or part thereof)  was authorized by the Board of Directors of the Corporation.  The right to indemnification conferred in this Section shall be a contract right and shall include the right to be paid by the Corporation the expenses incurred in defending any such proceeding in advance of its final disposition (hereinafter an "advancement of expenses"); provided, however, that, if the Florida Business Organizations Code requires, an advancement of expenses incurred by an indemnitee in his or her capacity as a director or officer (and not in any other capacity in which service was or is rendered by such indemnitee while a director or officer, including, without limitation, service to an employee benefit plan)  shall be made only upon delivery to the Corporation of an undertaking, by or on behalf of such indemnitee, to repay all amounts so advanced if it shall ultimately be  determined that such indemnitee is not entitled to be indemnified under this Section 1, or otherwise.

SECTION 2 .   Right of Indemnitee to Bring Suit .   If a claim under Section 1 of this Article is not paid in full by the Corporation within sixty days after a written claim has been received by the Corporation, except in the case of a claim for an advancement of expenses, in which case the applicable period shall be twenty days, the indemnitee may at any time thereafter bring suit against the Corporation to recover the unpaid amount of the claim and, to the extent successful in whole or in part, the indemnitee shall be entitled to be paid also the expense of prosecuting such suit.  The indemnitee shall be presumed to be entitled to indemnification under this Article upon submission of a written claim (and, in an action brought to enforce a claim for an advancement of expenses where the required undertaking, if any is required, has been tendered to the Corporation), and thereafter the Corporation shall have the burden of proof to overcome the presumption that the indemnitee is not so entitled.  Neither the failure of the Corporation (including its Board of Directors, independent legal counsel or its stockholders) to have made a determination prior to the commencement of such suit that indemnification of the indemnitee is proper in the circumstances nor an actual determination by the Corporation (including its Board of Directors, independent legal counsel or its stockholders) that the indemnitee is not entitled to indemnification shall be a defense to the suit or create a presumption that the indemnitee is not so entitled.

 
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SECTION 3.   Non-exclusivity of Rights . The rights to indemnification and to the advancement of expenses conferred in this Article shall not be exclusive of any other right which any person may have or hereafter acquire under any statute, provision of the Articles of Incorporation, Amended and Restated By-Laws, agreement, vote of stockholders or disinterested directors or otherwise.

SECTION 4 .   Insurance, Contracts and Funding .   The Corporation may maintain insurance, at its expense, to protect itself and any director, officer, employee or agent of the Corporation or another Corporation, partnership, joint venture, trust or other enterprise against any expense, liability or loss, whether or not the Corporation would have the power to indemnify such person against such expense, liability or loss under the N.R.S.  The Corporation may enter into contracts with any indemnitee in furtherance of the provisions of this Article and may create a trust fund, grant a security interest or use other means (including, without limitation, a letter of credit) to ensure the payment of such amounts as may be necessary to effect indemnification as provided in this Article.

SECTION 5 .   Definition of Director and Officer .  Any person who is or was serving as a director of a wholly owned subsidiary of the Corporation shall be deemed, for purposes of this Article only, to be a director or officer of the Corporation entitled to indemnification under this Article.

SECTION 6 .   Indemnification of Employees and Agents of the Corporation .  The Corporation may, by action of its Board of Directors from time to time, grant rights to indemnification and advancement of expenses to employees and agents of the Corporation with the same scope and effects as the provisions of this Article with respect to the indemnification and advancement of expenses of directors and officers of the Corporation.

ARTICLE XI
CHECKS, DRAFTS, BANK ACCOUNTS, ETC.

SECTION 1 .   Checks, Drafts, Etc.; Loans .  All checks, drafts or other orders for the payment of money, notes or other evidences of indebtedness issued in the name of the Corporation shall be signed by such officer or officers, agent or agents of the Corporation and in such manner as shall, from time to time, be determined by resolution of the Board of Directors.  No loans shall be contracted on behalf of the Corporation unless authorized by the Board of Directors.  Such authority may be general or confined to specific circumstances.

SECTION 2 .   Deposits .  All funds of the Corporation shall be deposited, from time to time, to the credit of the Corporation in such banks, trust companies or other depositories as the Board of Directors may select, or as may be selected by any officer or officers, agent or agents of the Corporation to whom such power may, from time to time, be delegated by the Board of Directors; and for the purpose of such deposit, the Chairman, the President, any Vice President, the Treasurer or any Assistant Treasurer, the Secretary or any Assistant Secretary or any other officer or agent to whom such power may be delegated by the Board of Directors,  may endorse, assign and deliver checks, drafts and other order for the payment of money which are payable to the order of the Corporation.

 
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ARTICLE XII
AMENDMENTS

These Amended and Restated By-Laws may be altered or repealed and new Amended and Restated By-Laws may be made by the affirmative vote, at any meeting of the Board, of a majority of the Board of Directors.
 
 

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Exhibit 4.1

 
LOGO  
ROSS MILLER
Secretary of State
204 North Carson Street, Suite 1
Carson City, Nevada 89701-4520
(775) 684 5708
Website: www.nvsos.gov

 
 
Certificate of Designation
(PURSUANT TO NRS 78.1955)
 
 
 

USE BLACK INK ONLY - DO NOT HIGHLIGHT
ABOVE SPACE IS FOR OFFICE USE ONLY

Certificate of Designation For
Nevada Profit Corporations
(Pursuant to NRS 78.1955)
1.  Name of corporation:

NANOVIRICIDES, INC.

2.  By resolution of the board of directors pursuant to a provision in the articles of incorporation this certificate establishes the following regarding the voting powers, designations, preferences, limitations, restrictions and relative rights of the following class or series of stock.

CERTIFICATE OF DESIGNATION, RIGHTS AND PREFERENCES
OF
SERIES A CONVERTIBLE PREFERRED STOCK
OF
NANOVIRICIDES, INC.

1.            Designation. The designation of the series of preferred stock created hereby shall be "Series A Convertible Preferred Stock" (the "Series A Preferred Stock") and the number of shares constituting the Series A Preferred Stock shall be 7,000,000 shares, par value $0.001 per share.

(balance attached)

3.  Effective date of filing: (optional)
 
(must not be later than 90 days after the certificate is filed)
4.  Signature: (required)
 
/s/ Eugene Seymour,
 
Signature of Officer
 
Filing Fee: $175.00
 
IMPORTANT: Failure to include any of the above information and submit with the proper fees may cause this filing to be rejected.
 
This form must be accompanied by appropriate fees.
Nevada Secretary of State Stock Designation
Revised: 3-6-09

 
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CERTIFICATE OF DESIGNATION, RIGHTS AND PREFERENCES
OF
SERIES A CONVERTIBLE PREFERRED STOCK
OF
NANOVIRICIDES, INC.

(Continued)

2.            Certain Definitions . For the purposes of the Certificate of Designation, Preferences and Rights which embodies this resolution, unless the context otherwise requires, capitalized terms used and not otherwise defined in such Certificate of Designation, Preferences and Rights shall have the following meanings (with terms defined in the singular having comparable meanings when used in the plural):
 
“Additional Shares of Common Stock” shall mean all shares (including treasury shares) of common stock issued or sold by the Company after the date hereof, whether or not subsequently reacquired or retired by the Company, other than (i) shares of common stock issued upon conversion of the Series A Preferred Stock or (ii) shares of common stock issued concurrently with the issuance of the Series A Preferred Stock.

“Business Day” shall mean any day on which banks are open for business in New York, New York (other than a Saturday or Sunday), provided that any reference to “days” (unless Business Days are specified) shall mean calendar days.

“Commission” shall mean the Securities and Exchange Commission or any successor federal agency having similar powers.

“Common Stock” shall mean the common stock of the Company, par value $.001 per share, and any stock into which such stock shall have been converted or changed or any stock resulting from any reclassification of such stock and all other stock of any class or classes (however designated) of the Company, the holders of which shall have the right, without limitation as to amount, either to all or to a share of the balance of current dividends and liquidating dividends after the payment of dividends and distributions on any shares entitled to preference.

“Company” shall mean NanoViricides, Inc., a Nevada corporation.

“Conversion Rate” shall mean the conversion rate set forth in Section 5.

“Convertible Security” shall mean with respect to the Company any evidence of indebtedness, shares of stock (other than Common Stock) or other securities directly or indirectly convertible into or exchangeable for Additional Shares of Common Stock.

“Exchange Act” shall mean the Securities Exchange Act of 1934, as amended.

“Holder” shall mean a holder of the Series A Preferred Stock.

“Intellectual Property” shall mean all of the patents, patent applications, provisional patent applications, and other proprietary intellectual property granted to the Company.

“Options” shall mean rights, options or warrants subscribe for, purchase or otherwise acquire Additional Shares of Common Stock or Convertible Securities.

 
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“Other Securities” shall mean, when referring to the Company, any stock (other than Company Common Stock) and any other securities of the Company or any other Person (corporate or otherwise) which the holder of Series A Preferred Stock shall at any time be entitled to receive, or shall have received, upon conversion of Series A Preferred Stock, in lieu of or in addition to Common Stock, or which at any time shall be issuable or shall have been issued in exchange for or in replacement of Common Stock or Other Securities.

“Securities Act” shall mean the Securities Act of 1933, as amended.


3.            Dividends and Distributions .  Holders of the Series A Preferred Stock shall not be entitled to receive dividends.


4.            Voting Rights :

  (a)           Each share of Series A Preferred Stock shall vote at the rate of four votes per share, together with the Common Stock, on all matters to which shareholders of the Company are entitled to vote.

  (b)           Whenever holders of the Series A Preferred Stock are required or permitted to take any action by vote, such action may be taken without a meeting on written consent, setting forth the action so taken and signed by the holders of the Series A Preferred Stock having not less than the minimum number of votes that would be necessary to authorize or take such action at a meeting at which all shares of Series A Preferred Stock entitled to vote thereon were present and voted.

  (c)           Holders of the Series A Preferred Stock shall vote together as a separate class on all matters which impact the rights, value, or ranking of the Common Stock or Series A Preferred Stock, as provided herein.

  (d)           So long as any shares of the Series A Preferred Stock are outstanding, the Company shall not without first obtaining the approval (by vote or written consent, as provided by law) of a majority of the then outstanding shares of the Series A Preferred Stock, voting as a separate class, by way of example and not limitation.:

 (i)           adversely alter or change the rights, preferences, designations or privileges of the Series A Preferred Stock; or

 (ii)          amend the Company’s Articles of Incorporation of By-laws in a manner that adversely affects the rights, preferences, designations or privileges of the holders of the Series A Preferred Stock;


5.            Conversion . The Holder of the Series A Preferred Stock shall have the right to convert (the “Conversion Rights”) the Series A Preferred Stock into shares of Common Stock solely upon a “Change of Control” of the Company.

  (a)            Change of Control Transaction .  For the purposes of this Certificate of Designation, a Change of Control shall mean the occurrence of any of (a) an acquisition after the date hereof by an individual or legal entity or “group” (as described in Rule 13d-5(b)(1) promulgated under the Exchange Act) of effective control (whether through legal or beneficial ownership of capital stock of the Company, by contract or otherwise) of in excess of 40% of the voting securities of the Company (other than by means of conversion or exercise of the Series A Preferred Stock and the Securities issued together with the Series A Preferred Stock), (b) the Company merges into or consolidates with any other Person, or any Person merges into or consolidates with the Company and, after giving effect to such transaction, the stockholders of the Company immediately prior to such transaction own less than 60% of the aggregate voting power of the Company or the successor entity of such transaction, (c) the Company sells or transfers all or substantially all of its Intellectual Property to another Person and the stockholders of the Company prior to such transaction own less than 60% of the aggregate voting power of the acquiring entity immediately after the transaction, or (d) the execution by the Company of an agreement to which the Company is a party or by which it is bound, providing for any of the events set forth in clauses (a) through (c) above.  In the event of a Change in Control, the Company shall deliver a written notice to the Holder of the Series A Preferred Stock at the Holder’s last known address as set forth in the Series A Preferred Stock Register, advising the Holder of the Change in Control (the “Notice”).

 
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  (b)            Conversion .  Upon the earlier to occur of a Change of Control Transaction or the delivery of Notice by the Company, the Holders of any shares of Series A Preferred Stock may, at such holder’s option, without any further consideration, at any time ,elect to convert all or any portion of the shares of Series A Preferred Stock held by such person into a number of fully paid and nonassessable shares of Common Stock on the basis four share of Common Stock per each share of Series A Preferred Stock converted, subject to adjustment as set forth herein (the “Conversion Rate”).  In the event of a liquidation, dissolution or winding up of the Company, the Conversion Rights shall terminate at the close of business on the last full day preceding the date fixed for the payment of any such amounts distributable on such event to the holders of Series A Preferred Stock.

  (c)            Mechanics of Conversion .  The conversion of the Series A Preferred Stock shall be conducted in the following manner:
 
 (i)          Holder’s Delivery Requirements.  To convert the Series A Preferred Stock into full shares of Common Stock on any date, the holder thereof shall transmit by overnight carrier (or otherwise deliver), for receipt on or prior to 5:00 p.m., New York time on such date, to the Company at its then principal offices, Attention: Chief Financial Officer, the original certificates representing the shares of Series A Preferred Stock being converted (the “Preferred Stock Certificates”) and the original, fully-executed notice of conversion in the form attached hereto as Exhibit A (the “Conversion Notice”).
 
 (ii)         Company’s Response. Upon receipt by the Company of the Conversion Notice and the Preferred Stock Certificates, the Company shall immediately send, via facsimile, a confirmation of receipt of such Conversion Notice to such holder and the Company or its designated transfer agent (the “Transfer Agent”), as applicable, shall, within five (5) business days following the date of receipt by the Company of the fully executed Conversion Notice and Preferred Stock Certificates, issue and deliver to the Holder, certificates registered in the name of the Holder or its designee, representing the number of shares of Common Stock to which the holder shall be entitled. If the number of shares of Series A Preferred Stock represented by the Preferred Stock Certificate(s) submitted for conversion is greater than the number of shares of Series A Preferred Stock being converted, then the Company shall, as soon as practicable and in no event later than five (5) business days after receipt of the Preferred Stock Certificate(s) and at the Company’s expense, issue and deliver to the holder a new Preferred Stock Certificate representing the number of shares of Series A Preferred Stock not converted.
 
 (iii)        Record Holder . The person or persons entitled to receive the shares of Common Stock issuable upon a conversion of the Series A Preferred Stock shall be treated for all purposes as the record holder or holders of such shares of Common Stock from and after the Conversion Date.

 
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  (d)            Reservation of Common Stock . The Company shall reserve out of its authorized but unissued shares of Common Stock that number of its shares of Common Stock as shall be sufficient to effect the conversion of all outstanding shares of the Series A Preferred Stock.

  (e)            Termination of Rights on Conversion . All shares of the Series A Preferred Stock converted as herein provided shall no longer be deemed to be outstanding, and all rights with respect to such shares, including the rights, if any, to receive dividends, notices and to vote, shall immediately cease and terminate on conversion, except only the right of the holders thereof to receive shares of Common Stock in exchange therefor. Any shares of Series A Preferred Stock so converted shall be retired and canceled and shall not be reissued, and the Company may from time-to-time take such appropriate action as may be necessary to reduce the number of shares of authorized Series A Preferred Stock accordingly.

 (f)             Adjustment for Reclassification, Exchange, or Substitution . If the Common Stock issuable upon the conversion of the Series A Preferred Stock shall be changed into the same or a different number of shares of any class or classes of stock, whether by capital reorganization, reclassification, or otherwise (other than a subdivision or combination of shares or stock dividend, or a reorganization, merger, consolidation, change of control, share exchange or sale of assets, as provided for below), then and in each such event the holder of each share of Series A Preferred Stock shall have the right thereafter to convert such share into the kind and amount of shares of stock and other securities and property receivable upon such reorganization, reclassification, or other change, by holders of the number of shares of Common Stock into which such shares of Series A Preferred Stock might have been converted immediately prior to such reorganization, reclassification, or change, all subject to further adjustment as provided herein.

 (g)            Adjustment for Merger, Reorganization, Change of Control, etc . In addition to the convertibility of the Series A Preferred Stock upon a Change of Control, in case of any consolidation, merger or share exchange of the Company with or into another corporation or the sale of all or substantially all of the assets of the Company to another corporation or in the event that there is a Change of Control, then each share of Series A Preferred Stock shall thereafter be convertible into the kind and amount of shares of stock or other securities or property to which a holder of the number of shares of Common Stock of the Company deliverable upon conversion of such Series A Preferred Stock would have been entitled upon such consolidation, merger or sale; and, in such case, appropriate adjustment (as determined in good faith by the Board of Directors) shall be made in the application of the provisions in this Section 5 set forth with respect to the rights and interest thereafter of the holders of the Series A Preferred Stock, to the end that the provisions set forth in this Section 5 (including provisions with respect to changes in and other adjustments of the Series A Conversion Rate) shall thereafter be applicable, as nearly as reasonably may be, in relation to any shares of stock or other property thereafter deliverable upon the conversion of the Series A Preferred Stock.

 (h)            Adjustment to Conversion Price Due to Stock Split, Stock Dividend, etc. If, prior to the Conversion of all of the Series A Preferred Stock, (A) the number of outstanding shares of Common Stock is increased by a stock split, a stock dividend on the Common Stock, a reclassification of the Common Stock, or the distribution to holders of Common Stock of rights or warrants entitling them to subscribe for or purchase Common Stock at less than the then current market price thereof (based upon the subscription or exercise price of such rights or warrants at the time of the issuance thereof), the Conversion Price shall be proportionately reduced, or (B) the number of outstanding shares of Common Stock is decreased by a reverse stock split, combination or reclassification of shares, the Conversion Price shall be proportionately increased.  In such event, the Company shall notify the Transfer Agent of such change on or before the effective date thereof.

 
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 (i)            No Impairment . The Company will not, by amendment of its Articles of Incorporation or through any reorganization, transfer of assets, consolidation, merger, share exchange, dissolution, issue or sale of securities or any other voluntary action, avoid or seek to avoid the observance or performance of any of the terms to be observed or performed hereunder by the Company, but will at all times in good faith assist in the carrying out of all the provisions of this Section 5 and in the taking of all such action as may be necessary or appropriate in order to protect the conversion rights of the holders of the Series A Preferred Stock against impairment.

  (j)            Certificate as to Adjustments . Upon the occurrence of each adjustment or readjustment of the Conversion Rate pursuant to this Section 5, the Company at its expense shall promptly compute such adjustment or readjustment in accordance with the terms hereof and furnish to each Holder a certificate setting forth such adjustment and showing in detail the facts upon which such adjustment or readjustment is based and shall file a copy of such certificate with its corporate records. The Company shall, upon the written request at any time of any holder of Series A Preferred Stock, furnish or cause to be furnished to such holder a similar certificate setting forth (1) such adjustments and readjustments, (2) the Conversion Rate then in effect, and (3) the number of shares of Common Stock and the amount, if any, of other property which then would be received upon the conversion of Series A Preferred Stock. Despite such adjustment or readjustment, the form of each or all stock certificate representing Series A Preferred Stock, if the same shall reflect the initial or any subsequent Conversion Rate, need not be changed in order for the adjustments or readjustments to be valued in accordance with the provisions of this Certificate of Designation, Preferences and Rights which shall control.

  (k)            Notice to Shareholders . If:

 (1)          the Company shall declare a dividend (or any other distribution) on its Common Stock; or

 (2)          the Company shall declare a special nonrecurring cash dividend or a redemption of its Common Stock; or

 (3)          the Company shall authorize the granting to all holders of the Common Stock rights or warrants to subscribe for or purchase any shares of capital stock of any class or of any rights; or

 (4)          the approval of any stockholders of the Company shall be required in connection with any reclassification of the Common Stock of the Company (other than a subdivision or combination of the outstanding shares of Common Stock), any consolidation or merger to which the Company is a party, any sale or transfer of all or substantially all of the assets of the Company, or any compulsory share exchange whereby the Common Stock is converted into other securities, cash or property; or

(5)           the Company shall authorize the voluntary or involuntary dissolution, liquidation or winding-up of the affairs of the Company;

Then the Company shall cause to be filed at each office or agency maintained for the purpose of conversion of Series A Preferred Stock, and shall cause to be mailed to the Holders of the Series A Preferred Stock at their last address as they shall appear upon the stock books of the Company, at least twenty (20) calendar days prior to the applicable record or effective date hereinafter specified, a notice stating (x) the date on which a record is to be taken for the purpose of such dividend, distribution, redemption, rights or warrants, or if a record is not to be taken, the date as of which the holders of Common Stock of record to be entitled to such dividend, distributions, redemption, rights or warrants are to be determined, or (y) the date on which such reclassification, consolidation, merger, sale, transfer, share exchange, dissolution, liquidation or winding-up is expected to become effective, and the date as of which it is expected that holders of Common Stock of record shall be entitled to exchange their shares of Common Stock for securities or other property deliverable upon such reclassification, consolidation, merger, sale, transfer, share exchange, dissolution, liquidation or winding-up; provided, however, that the failure to mail such notice or any defect therein or in the mailing thereof shall not affect the validity of the corporate action required to be specified in such notice.

 
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  (l)            Curative Provision . If at any time conditions shall arise by reason of action taken by the Company which in the opinion of the Board of Directors are not adequately covered by the other provisions hereof and which might materially and adversely affect the rights of the holders of Series A Preferred Stock (different than or distinguished from the effect generally on rights of holders of any class of the Company’s capital stock) or if at any time any such conditions are expected to arise by reason of any action contemplated by the Company, the Company shall mail a written notice briefly describing the action contemplated and the material adverse effects of such action on the rights of the holders of the Series A Preferred Stock at least thirty (30) calendar days prior to the effective date of such action, and an appraiser selected by the holders of a majority in interest of the Series A Preferred Stock shall give its opinion as to the adjustment, if any (not inconsistent with the standards established in this Section 5) of the Conversion Rate (including, if necessary, any adjustment as to the securities into which shares of Series A Preferred Stock may thereafter be convertible) and any distribution which is or would be required to preserve without diluting the rights of the holders of shares of Series A Preferred Stock; provided, however, that the Company, after receipt of the determination by such appraiser, shall have the right to select an additional appraiser, in which case the adjustment shall be equal to the average of the adjustments recommended by each such appraiser. The Board of Directors shall make the adjustment recommended forthwith upon the receipt of such opinion or opinions or the taking of any such action contemplated, as the case may be.

  (m)            Issuance Taxes . The issuance of certificates for shares of Common Stock on any conversion of Series A Preferred Stock shall be made without charge to the holders thereof for any documentary stamp or similar taxes that may be payable in respect of the issue or delivery of such certificate, provided that the Company shall not be required to pay any tax that may be payable in respect of any transfer involved in the issuance and delivery of any such certificate upon conversion in a name other than that of the holder of such shares of Series A Preferred Stock so converted and the Company shall not be required to issue or deliver such certificates or until the person or persons requesting the issuance thereof shall have paid to the Company the amount of such tax or shall have established to the satisfaction of the Company that such tax has been paid.


6.            Ranking . For purposes of the Certificate of Designation, Preferences and Rights embodying this resolution, any stock of any class or series of the Company shall be deemed to rank senior to shares of the Series A Preferred Stock, either as to dividends or upon liquidation, if the holders of stock of such class or series shall be entitled by the terms thereof to the receipt of dividends or of amounts distributable upon liquidation, dissolution or winding up, as the case may be, in preference or priority to the Holder of shares of the Series A Preferred Stock.


7.            Liquidation, Dissolution or Winding Up . For purposes of the Certificate of Designation, Preferences and Rights the shares of Series A Preferred Stock shall not be entitled to a Liquidation Preference with the Common Stock and the other classes of the Company’s securities upon the liquidation, dissolution, or winding up of the Company.

 
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8.            Miscellaneous Provisions .

  (a)            Shares Restricted . Neither the shares of Series A Preferred Stock nor the shares of Common Stock into which they are convertible have been registered under the United States Securities Act of 1933, as amended, or applicable state securities laws. Such securities have been offered, sold and issued pursuant to exemptions from such laws.

  (b)            Closing of Books . The Company will at no time close its transfer books against the transfer of any shares of Series A Preferred Stock or of any share of the Common Stock issued or issuable upon the conversion of Series A Preferred Stock in any manner which interferes with the timely conversion of such Series A Preferred Stock.

  (c)           Headings of Subdivisions . The headings of the various Sections and other subdivisions hereof are for convenience of reference only and shall not affect the interpretation of any of the provisions hereof.

  (d)           Severability of Provisions . If any voting powers, preferences and relative, participating, optional and other special rights of the Series A Preferred Stock and qualifications, limitations and restrictions thereon set forth in the Certificate of Designation, Preferences and Rights embodying this resolution is invalid, unlawful or incapable of being enforced by reason of any rule of law or public policy, all other powers, preferences and relative, participating, optional and other special rights of Series A Preferred Stock and qualifications, limitations and restrictions thereon set forth therein which can be given effect without the invalid, unlawful or unenforceable voting powers, preferences and relative, participating, optional and other special rights of Series A Preferred Stock and qualifications, limitations and restrictions thereon shall, nevertheless, remain in full force and effect, and no voting powers, preferences and relative, participating, optional or other special rights of Series A Preferred Stock and qualifications, limitations and restrictions thereon herein set forth shall be deemed dependent upon any other such voting powers, preferences and relative, participating, optional or other special rights of Series A Preferred Stock and qualifications, limitations and restrictions thereon unless so expressed herein.

 
8


Exhibit 10.1
 
 
THERACOUR-NANOVIRICIDES ADDITIONAL LICENSE AGREEMENT
 
 
This License Agreement (the "Agreement") is made between TheraCour Pharma, Inc. a Connecticut corporation (collectively referred to as "TheraCour" or “Theracour”) and NanoViricides, Inc., a Nevada corporation ("Nano").
 
BACKGROUND
 
1.           TheraCour is engaged in a long-term effort for the research, development and commercialization of certain proprietary drug delivery and targeting technologies, including but not limited to the type falling within the scope of its patent applications, patents, and proprietary products licensed under this Agreement. TheraCour is entering into this Agreement, in furtherance of such research, development, and commercialization of its drug delivery and targeting technologies.
 
2.           Nano desires to obtain a license for specific products, to be developed, under such patents, and patent applications and/or proprietary technologies, to make, have made, use and sell pharmaceuticals for certain viral diseases, and subject to certain field, format and other limitations more specifically set forth below, and TheraCour is willing to grant such a license pursuant to the terms and conditions set forth herein.
 
AGREEMENT
 
NOW, THEREFORE, in consideration of the above provisions and the mutual covenants contained herein, the parties agree as follows:
 
1.             Definitions
 
The following defined terms shall have the meanings set forth below (with derivative forms being interpreted accordingly):
 
1.1           "Affiliate" shall mean:
 
 
1.1.1
any entity that directly or indirectly controls, is controlled by, or is under common control with another entity, and for such purpose "control" shall mean (a) the possession, direct or indirect, of more than 50 percent of the voting power or beneficial interest in the entity, whether through ownership of voting securities, by contract or otherwise, or (b) having the power to govern the financial or operating policies or to appoint the management of the controlled organization, or by (c) contractual or other means, the right to participate with, control, direct or otherwise act in concert or derive any benefit from the activities of such entity.

Page 1 of 14

 
 
 
1.1.2
any entity that directly or indirectly has a minority stock interest in the other entity .
 
1.2           "Calendar Year" shall mean the twelve (12) month period beginning January 1 and ending December 31 in the same year.
 
1.3           "Effective Date" shall mean the date this Agreement is executed by the latest signing party.
 
1.4           ''End User" shall mean a person or entity whose use of Licensed Product results in its consumption, destruction, or loss of activity (in each case, whether whole or partial).
 
1.5             "FDA" shall mean the U.S. Food and Drug Administration and any successor . thereto.
 
1.6           "Licensed Product" shall mean any product the manufacture, use or sale of which product would, in the absence of the license granted to Nano hereunder, infringe a Valid Patent Claim, Patent Application or a Proprietary Claim covering such manufacture, use or sale in any of the countries of manufacture, use or sale for the following viral diseases set forth in the License Grant below.
 
1.7           "Licensed Patent" shall mean a claim in a patent or patent application listed in Exhibit A or that is entitled to the priority of a patent, patent application, or provisional patent application listed in Exhibit A, or that is entitled as a claim in a subsequent patent application derived from subject matter that is further refinement of or substantially inherited from or disclosed in a patent or patent application or provisional patent application listed in Exhibit A, including claims in any divisions, extensions, renewals, reissues, re-examination certificates and continuations of such patents, patent applications, and provisional patent applications. If a priority claim is abandoned or lost for any reason including applicable regulatory or legal time limitations, nevertheless the patent or patent claim that would be eligible for (i) claiming priority without consideration of any such time limitations imposed by law, or (ii) exhibiting dependence as derivative from a patent or patent application or provisional patent application listed in Exhibit A shall be considered a “Licensed Patent” in this Agreement.

Page 2 of 14

 
 
1.8           "Ship", "Shipped" or "Shipment" shall mean the delivery of any unit of Licensed Product by Nano to a third party for any commercial purpose, except (i) any unit of Licensed Product for which said third party receives an actual credit for goods damaged during transit, warranty replacement (excluding expired goods) and product recalls, (ii) any unit delivered without charge solely for purposes of preclinical or clinical trials that are required for regulatory approval in that country and that are conducted prior to the first regulatory approval of the affected product in that country, and (iii) any unit delivered as free samples for customer evaluation, up to the maximum number of units permitted for such purpose.
 
1.9           "Territory" shall mean all countries of the world.
 
1.10          "Third Party" shall mean any person or entity other than TheraCour and Nano or any of their respective Affiliates.
 
1.11          "Valid Patent Claim" shall mean a claim in any issued or granted, unexpired patent, or in any patent application or provisional patent application, that is included in Licensed Products, which claim has not been held unpatentable, invalid or unenforceable by a non-appealed or unappealable decision by a court or other appropriate body of competent jurisdiction, or lapsed, become abandoned or expired. If a pending Valid Patent Claim ceases to be a Valid Patent Claim because it has gone abandoned, but such pending claim is later revived, then once it ceases to be abandoned, it shall again qualify as a Valid Patent Claim. Where elsewhere in this Agreement the phrase "would infringe a Valid Claim" or similar terminology is used, pending Valid Patent Claims shall be evaluated as if issued in the country in which such pending Valid Patent Claims are pending.
 
1.12          “Proprietary Claim" shall mean a claim regarding proprietary technologies or confidential information owned by TheraCour, that is included in or used in the. research, development, manufacture, packaging, or use of Licensed Products.
 
1.13          "Claim" shall mean a Valid Patent Claim or a Proprietary Claim as defined above.
 
2.               License Grant . TheraCour hereby grants to Nano a limited, non-transferable. exclusive license for the use, sale. or offer of sale of the Licensed Product(s) in the Territory.

Page 3 of 14

 
 
2.1            Licensed Products.   The products herein licensed shall include all drugs developed by TheraCour, for payment by Nano of Costs, Development Fees, Royalties and other consideration as outlined below, for the treatment of the following human viral diseases: Dengue Fever type I,II,III & IV; Japanese Encephalitis; West Nile Virus; Ebola/Marburg; Adenoviral Conjuntivitis/Keratitis; and Ocular Indications of Herpes Simplex Type 1 & 2 . The term "virus" shall include all currently medically recognized human viral strains identified for the specified viruses.
 
2.2            Additional Licensed Products:    TheraCour may, but has no obligation to, license additional developmental products for treatment of additional viral diseases to Nano, after Nano has developed and commercialized at least one drug candidate.
 
2.3           TheraCour retains the exclusive right to develop and manufacture the aforesaid drugs. As to any Licensed Product, TheraCour agrees that it will manufacture such drug exclusively for Nano, and unless such license is terminated, will not manufacture such product for its own sake or for others. Nano agrees that TheraCour shall automatically have a license to employ Nano’s proprietary or patented technologies or other know how for the purpose of manufacturing the drug as may be required without payment of any consideration therefore, whether cash or non-cash considerations, irrespective of whether such consideration is with or without monetary value.
 
3.              Licensing Fees. Development Fees and Royalties.
 
In consideration of TheraCour granting Nano the license herein, Nano agrees to pay TheraCour the following licensing fees, development fees and royalties.
 
3.1           Upon execution, a licensing fee of 7 million shares of NanoViricides, Inc. Series A convertible Preferred Stock, the rights of which are set forth in the Certificate of Designation attached hereto.
 
3.2            Development Fee. TheraCour shall be the sole developer of all Licensed Products. TheraCour shall charge all of its costs, direct costs (as hereinafter defined), as well as indirect costs, plus a fee equal to thirty (30%) percent of such direct costs. To the extent not paid pursuant to prior license agreements, Nano shall further pay to TheraCour a monthly laboratory facilities fee of $25,000.00. In consideration of such fee, TheraCour shall use all the nano-materials and chemicals in its existing inventory in the development of the licensed product(s) as required. The above shall constitute the Development Fee to be paid to TheraCour.
 
Page 4 of 14

 
 
3.2.1          Advance Payments . TheraCour may request, and Nano agrees to provide, an advance payment equal to two months of estimated future development costs, as pursuant to prior agreements.
 
3.3            Direct Costs . Direct Costs shall include all salaries and wages including all payroll taxes, Workers Compensation premiums, employee benefits, consultants providing services directly related to the development of the licensed product(s), lab supplies and chemicals, and reasonable and customary charges for items such as future hazardous materials disposal according to local law and regulations. The costs may also include the costs for protection of all intellectual property rights related to the development. Any other costs incurred during the conduct of the development project will also be charged as development costs. In addition, to the extent not paid pursuant to prior agreements, the following monthly amounts of expenses may be billed with no need for a voucher: Office Supplies ($500); Travel and Entertainment ($500); External Consultants ($500); and Miscellaneous Expenses ($500) as pursuant to prior agreement and not in addition. Such Development fees shall be due and payable in periodic installments as billed, along with advance payments as requested. Salaries paid to Dr. Anil Diwan and Dr. Jayant Tatake shall not be included as Development Costs, but such salaries, benefits and other payments shall be reimbursed in full by Nano.
 
3.4            Royalties . Nano shall pay to TheraCour a royalty of 15% on its net sales and other revenue proceeds of Licensed Products. Net sales are defined as Sales at gross invoice amounts less any adjustments for returns, allowances, or discounts taken against the sales and no other adjustments. Other Revenue Proceeds include all revenues or consideration generated as a result of the development of Licensed Products or from further licensing by Nano of any rights resulting from the Licensed Products or Technologies. Both Net Sales and Other Revenue Proceeds shall include cash as well as non-cash considerations, irrespective of whether such consideration is with or without monetary value.
 
3.4           Nano shall make its best efforts to market and commercialize any Licensed Product that is approved for marketing or sales in a region of the Territory.
 
 
(i).
If Nano determines not to proceed to do so, then Nano shall promptly notify TheraCour as such and TheraCour subsequently shall have all rights to such Product including right to market the product or license it to other parties provided that TheraCour arranges to pay back the amounts financed by Nano for the said product.

Page 5 of 14

 
 
 
(ii).
If Nano fails to market an approved product within a reasonable period of time, then TheraCour shall have the right to buy back the rights to the said product by arranging to repay the costs financed by Nano for the said product.
 
3.5           If Nano decides to terminate the development of any Licensed Product at any stage, all rights provided to Nano for said product shall reinvest in TheraCour. TheraCour may declare that Nano has terminated the development of a Licensed Product by giving a 90 days notice cure (the "Cure period") to Nano if Nano fails to or refuses to (a) pay the licensing fees in a timely manner, (b) pay the development costs (including advance payments as specified above) of any Licensed Product in a timely manner, (c) pay royalties and development costs when due, or (d) market, sell and/or commercialize the licensed product(s) as agreed to. Upon the expiration of the cure period the licenses granted herein for such licensed product are cancelled and void.
 
3.6           Records: Reports. Nano shall keep complete and accurate records of the Shipment of Licensed Products hereunder and other revenue proceeds related to the Licensed Products hereunder for no less than five (5) years after the time period to which they relate. Nano shall within 60 days following the end of each calendar quarter deliver to TheraCour a written report for such period setting forth the product Shipped, the number of units delivered for preclinical or clinical study purposes or provided as free samples pursuant to this Agreement and setting forth the royalties accrued during such period, (specifying with respect to the quantity of each Licensed Product for sale and other revenue proceeds).
 
3.7            Audits. TheraCour shall have the right to have an independent certified public accounting firm reasonably acceptable to Nano (such acceptance not to be unreasonably withheld, delayed or conditioned) audit Nano's Licensed Product-related records. Nano shall permit such firm access to Nano's records during reasonable business hours for the purpose of verifying the royalties as provided for in this Agreement, but no more frequently than once per year. Such firm shall agree to keep all information received strictly confidential and will provide to TheraCour only the information necessary to verify the royalty calculations.   If any such audit results in a change upward in any royalty payment Nano shall pay such additional amount, with compound interest. If such additional amount exceeds 5%, Nano shall additionally pay the costs of such audit promptly.
 
3.8           Upon termination of this agreement for any cause, Nano shall duly account to TheraCour and shall transfer to TheraCour all rights that it may possess in contracts, sub-licenses, letters patent, inventions, trade names, and trademarks, relating to the Licensed Product(s).
 
Page 6 of 14

 
4.              Payment.
 
4.1            Currency: Payment Timing. Except to the extent provided under Paragraph 3.1, payment of royalties under this Agreement shall be in U.S. Dollars and made within 30 days following the end of each calendar quarter for royalties accrued during such period in accordance with Article 3.
 
4.2            Transfers. All payments of cash value under this Agreement shall be made by bank wire transfer to the bank account designated, in writing, by TheraCour and which shall be authorized to accept payment on behalf of TheraCour. Any late payments shall bear interest monthly at the lesser of (i) two percent (2%) more than the prime rate then in effect of Chase Manhattan Bank, New York, New York (or any successor to Chase, or if Chase ceases to quote such rate and does not have a successor entity a comparable bank), or (ii) the maximum rate permitted by applicable law.
 
5.              Representations and Warranties
 
5.1            Representations and Warranties. Theracour and Nano each represent and warrant to the other that they have the full right and power to enter into this Agreement and grant the licenses that such parties are granting as set forth in this Agreement.
 
5.2.            Disclaimer . EXCEPT AS SPECIFICALLY SET FORTH IN PARAGRAPH 5.1 HEREIN, NO PARTY MAKES ANY REPRESENTATION OR WARRANTY, EITHER EXPRESS OR IMPLIED, ARISING BY LAW OR OTHERWISE, INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT WILL ANY PARTY LICENSING TECHNOLOGY TO THE OTHER PARTY HAVE, AS A RESULT OF SUCH LICENSE, ANY OBLIGATION OR LIABILITY ARISING FROM TORT, OR FOR LOSS OF REVENUE OR PROFIT, OR FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES.
 
In particular, with no limitation implied, nothing in this Agreement will be construed as:
 
 
1) A warranty or representation as to the validity or scope of any of the Licensed Products, Patents or Patent Applications;
 
 
2) A warranty or representation that anything made, used, sold, or otherwise disposed of under the licenses granted in this Agreement is or will be free from infringement of patents of third parties;
 
Page 7 of 14

 

 
3) An obligation to or for the licensing parties to bring or prosecute actions or suits against third parties for Licensed Patent infringement or a right for the Licensed Party to do so;
 
 
4) Conferring the right to use in advertising, publicity, or otherwise any trademark, trade name, or any contraction, abbreviation, simulation, or adaptation thereof, of another party except to the extent of the licenses herein granted; or
 
 
5) Except as otherwise provided herein, conferring by implication, estoppel, or otherwise, any license or rights under any patents other than as to the Licensed Products, or any license under any other property rights, such as know-how, clinical data, trademarks or trade names.
 
6.              Term. Termination
 
6.1            Term. This Agreement is in force and effect on and as of the Effective Date, and shall continue in effect until the expiration of the last to expire of the Patents underlying the Licensed Products ("last expiration date"), unless earlier terminated as provided herein. If at said last expiration date, Nano continues to use any proprietary technologies developed by TheraCour for any of the Licensed Products, then this agreement will continue to remain in force as long as Nano continues to use such proprietary technologies of TheraCour.
 
6.2            Termination .
 
 
6.2.1
The licenses granted to Nano hereunder may be terminated by TheraCour upon written notice to Nano in case of (a) the institution by or against Nano of insolvency, receivership or bankruptcy proceedings or any other proceedings for the settlement of Nano's debts; (b) Nano's making a general assignment for the benefit of its creditors; (c) Nano's dissolution; (d) Nano's cessation of business for a period of ninety (90) days or more; or (e) Nano or any of its Affiliates voluntarily acting or assisting others to challenge or invalidate the Licensed Patents in any opposition, declaratory judgment or other proceedings.
 
 
6.2.2
Nano may terminate this Agreement on 90 days notice to TheraCour, providing it pays to said parties all monies due and owing as of the date of such notice to terminate, and further providing that it ceases all sales of Licensed Products and destroys all stocks of product not otherwise shipped and transfers all related documentation to TheraCour.
 
Page 8 of 14

 

 
6.2.3
All rights to the Licensed Products and technologies shall revert to TheraCour upon termination of the Agreement.
 
6.3            Non-Waiver. Failure to terminate this Agreement following a material breach or failure to comply with this Agreement shall not constitute a waiver of a party's defenses, rights or causes of action arising from such or any future breach or noncompliance.
 
 
6.4            Survival. Articles 7 and 8 shall survive any and all expirations and terminations of this Agreement.
 
7.              Confidential Information
 
From time to time during the term of this Agreement, TheraCour, on the one hand, and Nano, on the other, may provide to each other information concerning patents, patent applications, license agreements and other confidential or proprietary information related to this Agreement and the Licensed Products (the "Information"). Each party receiving such Information (the ''Receiving Party") shall during the term of this Agreement and for a period of ten (10) years after termination hereof: (i) maintain the Information in confidence; (ii) not disclose the Information or any portion or copy of it to any third party; and (iii) not use the Information or any portion or copy of it for any purpose not directly related to performance of its obligations under this Agreement. The obligations of this Section shall not apply to any Information which is at the time of disclosure or thereafter becomes generally known to the public by means other than a breach of a duty by the Receiving Party or a breach of this Agreement. The Receiving Party shall disclose the Information only to those officers, employees and agents bound by similar terms of confidentiality to those imposed on the Receiving Party hereunder. Upon termination of this Agreement for any reason, the Receiving Party shall return all Information and copies thereof. The Receiving Party may disclose Information if required to comply with law or court order; provided, however, that it provides the Disclosing Party with advance notice of the required disclosure and all reasonable assistance to seek confidential treatment or a protective order.
 
Page 9 of 14

 
 
8.               Miscellaneous
 
8.1            Severability: Compliance with Law. In performing this Agreement, the parties shall comply with all applicable laws. Nothing in this Agreement shall be construed so as to require the violation of any law, and wherever there is any conflict between any provision of this Agreement and any law, the law shall prevail and the provision shall be appropriately adjusted, but in such event the affected provision of this Agreement shall be adjusted only to the extent necessary to bring it within the applicable law and accomplish the intent of the parties.
 
8.2            Notices. Any notice, report, demand or other communication required or permitted to be given by this Agreement shall be in writing in English, and shall be given by facsimile and by postpaid, first class, registered or certified mail addressed as set forth below unless changed by notice so given:
 
For TheraCour:
For Nano:
TheraCour Pharma, Inc.
NanoViricides, Inc.
135 Wood Street, Ste. 200
135 Wood Street, Ste. 205
West Haven, CT 06516, U.S.A.
West Haven, CT 06516, U.S.A.
Attn: Chief Executive Officer
Attn: Chief Executive Officer
cc: General Counsel
cc: General Counsel.
 
8.3            Force Majeure. No party to this Agreement shall be liable for delay or failure in the performance of any of its obligations hereunder if such delay or failure is due to causes beyond its reasonable control or ability to plan for, including, without limitation, acts of God, fires, earthquakes, strikes and labor disputes, acts of war, civil unrest or intervention of any governmental authority, but any such delay or failure shall be remedied by such party as soon as is reasonably possible, and if such delay or failure last for more than ninety (90) days, the other party or parties shall be entitled to terminate this Agreement.
 
8.4            Assignments. Nano may not assign its rights and obligations under this Agreement without the written consent of the other parties hereto. Without limiting the generality of the foregoing, this Agreement shall inure to the benefit of and be binding on the permitted assigns, Affiliates and subsidiaries of the parties.
 
8.5            No Third Party Beneficiaries. This Agreement is entered into solely for the benefit of the parties hereto, and the provisions of this Agreement shall be for the sole and exclusive benefit of such parties. Nothing herein contained will be deemed to create any third party beneficiaries or confer any benefit or rights on or to any person not a party hereto, and no person not a party hereto shall be entitled to enforce any provisions hereof or exercise any rights hereunder.
 
8.6            Waivers and Modifications. The failure of any party to insist on the performance of any obligation hereunder shall not act as a waiver of such obligation. No waiver, modification, release or amendment of any obligation under this Agreement shall be valid or effective unless in writing and signed by duly authorized officers of each party hereto.
 
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8.7            Choice of Law. This Agreement is subject to and shall be construed and enforced in accordance with the laws of the state of New York, with giving effect to any conflict of law principles that would apply the law of another jurisdiction.
 
8.8            Dispute Resolution.
 
 
8.8.1
Any controversy or claim arising out of or relating to this Agreement or the validity, inducement, or breach thereof, shall be settled by arbitration before a single arbitrator in accordance with the commercial Arbitration Rules of the American Arbitration Association ("AAA") then pertaining, except where those rules conflict with this provision, in which case this provision controls. The parties hereby consent to the personal jurisdiction of the Federal District Court for the Southern District of New York (and to the extent that federal subject matter jurisdiction is lacking, to New York state courts within such Southern District) for the enforcement of these provisions and the entry of judgment on any award rendered hereunder. Should such court for any reason lack jurisdiction, any court with jurisdiction shall enforce this clause and enter judgment on any award. The arbitrator shall be an attorney specializing in business litigation who has at least 15 years of experience with a law firm of over 25 lawyers or was a judge of a court of general jurisdiction. The arbitration shall be held in Manhattan and the arbitrator shall apply the substantive law of the State of New York, except that the interpretation and enforcement of this arbitration provision shall be governed by the Federal Arbitration Act. Within 30 days of initiation of arbitration, the parties shall reach agreement upon and thereafter follow procedures assuring that the arbitration will be concluded and the award rendered within no more than six months from the selection of the arbitrator. Failing such agreement, the AAA will design and the parties will follow such procedures. Each party has the right before or during the arbitration to seek and obtain from the appropriate court provisional remedies such as attachment, preliminary injunction, replevin, etc, to avoid irreparable harm, maintain the status quo or preserve the subject matter of the arbitration. THE ARBITRATOR SHALL NOT AWARD ANY PARTY PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES, AND EACH PARTY HEREBY IRREVOCABLY WAIVES ANY RIGHT TO SEEK. SUCH DAMAGES.

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8.8.2
Nothing in this Section 8.8 shall be deemed to preclude a party from bringing suit against the other party in a court of competent jurisdiction to enforce, or enjoin infringement of, such party's intellectual property rights.
 
8.9            Headings. The headings of the sections of this Agreement have been inserted for convenience of reference only and do not constitute a part of this Agreement.
 
8.10           Entire Agreement. This Agreement constitutes the entire agreement between the parties as to the subject matter hereof, and all prior negotiations, representations, agreements and understandings are merged into, extinguished by and completely expressed by this Agreement.
 
8.11           Draftsmanship. This Agreement has been jointly prepared by the parties and shall not be strictly construed against any of them.
 
8.12          Counterparts. This Agreement may be executed in any number of counterparts with the same effect as if all parties had signed the same document. All such counterparts shall be deemed an original, shall be construed together and shall constitute one and the same instrument.
 
IN WITNESS WHEREOF, the parties have duly executed this Agreement on the date(s) written below.
 
TheraCour Pharma, Inc.
NanoViricides, Inc.
   
   
By: /s/ Anil Diwan
By: /s/ Eugene Seymour
Name: Anil R. Diwan. Ph.D.
Name: Eugene Seymour, M.D.
Title: Chief Executive Officer
Title: Chief Executive Officer
Date: February 15, 2010
Date: February 15, 2010
 
Page 12 of 14

 

EXHIBIT A
 
LICENSED PATENTS AND PATENT APPLICATIONS
 
1.
"SOLUBILIZATION AND TARGETED DELIVERY OF DRUGS WITH SELF-ASSEMBLING AMPHIPHILIC POLYMERS,"   as described in an Application for Letters Patent of the Unites States of America, Application No. PCT/US2006/001820, filed January 19, 2006.
 
2.
"AMPHIPHILIC POLYMERIC MATERIALS," as described in Letters Patent of the United States of America, Serial No. US 6,521,736, filed February 18, 2003.
 
 
3.
“SELF-ASSEMBLING AMPHIPHILIC POLYMERS AS ANTIVIRAL AGENTS,” as described in an Application for Letters Patent of the Unites States of America, Application No. PCT/US07/01607, filed January 19, 2007.

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EXHIBIT B
 
CERTIFICATE OF DESIGNATION
 
 
Page 14 of 14


Exhibit 31.1
Certification
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, Eugene Seymour, certify that:

1.
I have reviewed this quarterly report on Form 10-Q of NanoViricides, Inc.;

2.           Based on my knowledge, this quarterly 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 quarterly report;

3.           Based on my knowledge, the financial statements, and other financial information included in this quarterly 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 quarterly 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)) for the registrant and have:

a)           Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly 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 quarterly 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 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 registrant’s board of directors (or persons performing the equivalent functions):

a)           All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b)           Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date:  February  22, 2010
 
 
/s/ Eugene Seymour, MD
 
 
Eugene Seymour, M.D. Chief Executive Officer,
 
Interim Chief Financial Officer and Director
 
(Principal Executive and Financial Officer)
 
 


Exhibit 32.1

CERTIFICATION PURSUANT TO
18 U.S.C. §1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report on Form 10-Q (the “Report”) of NanoViricides, Inc. (the “Company”) for the quarter ended December 31, 2009, each of the undersigned Eugene Seymour, the Chief Executive Officer of the Company, and, the Chief Financial Officer of the Company, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of the undersigned’s knowledge and belief:

 
(1)
the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 
(2)
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Dated: February 22, 2010
/s/ Eugene Seymour
 
Eugene Seymour
 
Chief Executive Officer and  Interim
 
Chief Financial Officer
 
(Principal Executive and Financial Officer)