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As filed with the Securities and Exchange Commission on May 29, 2007

Registration No. 333-140714


U.S. SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


AMENDMENT NO. 3

TO

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

 


NOVABAY PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in Its Charter)

 


 

California   2834   68-0454536

(State or Other Jurisdiction of

Incorporation or Organization)

 

(Primary Standard Industrial

Classification Number)

 

(I.R.S. Employer

Identification No.)

5980 Horton Street, Suite 550

Emeryville, CA 94608

(510) 899-8800

(Address, Including Zip Code and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)

 


Ramin (“Ron”) Najafi, Ph.D.

Chairman of the Board, Chief Executive Officer and President

NovaBay Pharmaceuticals, Inc.

5980 Horton Street, Suite 550 Emeryville, CA 94608

(510) 899-8800

(Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent for Service)

 


Copies to:

 

Chris Barry, Esq.

Dorsey & Whitney LLP

U.S. Bank Centre

1420 Fifth Avenue, Suite 3400

Seattle, WA 98101-4010

(206) 903-8815

 

Riccardo A. Leofanti, Esq.

Skadden, Arps, Slate, Meagher & Flom LLP

222 Bay Street, Suite 1750

Toronto, Ontario M5K 1J5

(416) 777-4700

Robert Mason, Esq.

Fasken Martineau DuMoulin LLP

66 Wellington Street West

Suite 4200

Toronto, Ontario M5K 1N6

(416) 366-8381

 

John Kolada, Esq.

Blake, Cassels & Graydon LLP

Commerce Court West, Suite 2800

Toronto, Ontario M5L 1A9

(416) 863-2400

 


Approximate date of commencement of proposed sale to the public:     As soon as practicable after this Registration Statement becomes effective.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box.     ¨

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.     ¨

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.     ¨

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.     ¨

 


CALCULATION OF REGISTRATION FEE

 


Title of Each Class of Securities to be Registered   

    Proposed Maximum    
Aggregate

    Offering Price(1)(2)    

  

Amount of

Registration Fee

Common Stock, $0.01 par value

   $23,000,000    $2,461(3)

(1) Includes the offering price attributable to shares that the underwriters have the option to purchase solely to cover over-allotments, if any.
(2) Estimated solely for the purpose of computing the registration fee pursuant to Rule 457(o) under the Securities Act of 1933, as amended.
(3) Previously paid.

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

 



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EXPLANATORY NOTE

This Registration Statement contains a prospectus relating to an offering of our common stock in the United States, together with separate prospectus pages relating to an offering of our common stock in Canada. The U.S. prospectus and the Canadian prospectus will be identical in all material respects. The complete U.S. prospectus is included herein and is followed by those pages to be used solely in the Canadian prospectus. Each of the alternative pages for the Canadian prospectus included in this registration statement has been labeled “Alternate Page for Canadian Prospectus.”


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The information in this prospectus is not complete and may be changed. We cannot sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

 

Subject to completion, dated                         , 2007

PROSPECTUS

             Shares

LOGO

Common Stock

 


This is NovaBay Pharmaceuticals, Inc.’s initial public offering in the United States and Canada. NovaBay Pharmaceuticals, Inc. is selling all of the shares of common stock offered by this prospectus.

We expect the public offering price to be between $             and $             per share. Currently, no public market exists for the shares. After pricing the offering, we expect that the common stock will be traded on the American Stock Exchange and on the Toronto Stock Exchange under the symbol “NBY.”

Investing in our common stock involves risks. See “ Risk Factors ” beginning on page 8.

 


PRICE $             PER SHARE

 


 

     Per Share    Total

Public offering price

   $                 $             

Underwriting discounts and commissions

   $      $  

Net proceeds, before expenses, to us

   $      $  

The underwriters may also purchase up to an additional              shares from us at the public offering price, less the underwriting discounts and commissions, until 30 days after the date of the closing of this offering to cover over-allotments, if any. The table above provides the maximum amount of underwriting discounts and commissions. Discounts and commissions on the sale of shares to certain investors identified by us will be 0.7% rather than 7%, and to the extent such investors purchase shares in this offering the aggregate underwriting discounts and commissions will be reduced accordingly. In addition, we have agreed to issue to the underwriters broker warrants to purchase up to 7% of the total number of shares sold in this offering, including pursuant to the over-allotment option.

The underwriters expect to deliver the shares on or about                         , 2007.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

 


Dundee Securities

 


The date of this prospectus is                         , 2007.

 


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TABLE OF CONTENTS

 

     Page

PROSPECTUS SUMMARY

   1

RISK FACTORS

   8

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

   27

USE OF PROCEEDS

   28

DIVIDEND POLICY

   28

CAPITALIZATION

   29

DILUTION

   30

SELECTED FINANCIAL DATA

   32

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

   34

BUSINESS

   49

MANAGEMENT

   82

RELATED PARTY TRANSACTIONS

   98

PRINCIPAL SHAREHOLDERS

   99

DESCRIPTION OF CAPITAL STOCK

   101

PRIOR SALES OF SHARES

   104

SHARES ELIGIBLE FOR FUTURE SALE

   105

MATERIAL U.S. FEDERAL INCOME AND ESTATE TAX CONSIDERATIONS TO NON-U.S. HOLDERS

   109

MATERIAL CANADIAN FEDERAL INCOME TAX CONSIDERATIONS

   112

UNDERWRITING

   115

NOTICE TO INVESTORS

   119

LEGAL MATTERS

   120

EXPERTS

   120

WHERE YOU CAN FIND MORE INFORMATION

   121

INDEX TO FINANCIAL STATEMENTS

   F-1

 


You should rely only on the information contained in this prospectus. We have not, and the underwriters have not, authorized any other person to provide you with additional or different information. If anyone provides you different or inconsistent information, you should not rely on it. We and the underwriters are offering to sell and seeking offers to buy shares of our common stock only in jurisdictions where offers or sales are permitted. The information in this prospectus is only accurate as of the date of this prospectus, regardless of the time of delivery of this prospectus or of any sale of our common stock. Our business, financial condition, results of operations and prospects may have changed since the date of this prospectus.


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PROSPECTUS SUMMARY

This summary highlights information contained elsewhere in this prospectus. You should read the following summary together with the more detailed information appearing in this prospectus, including the “Risk Factors” and our financial statements and related notes included elsewhere in this prospectus, before deciding whether to purchase shares of our common stock. Unless the context otherwise requires, all references in this prospectus to “we,” “our,” “us,” the “Company” and “NovaBay” refer to NovaBay Pharmaceuticals, Inc.

Our Company

Overview

We are a biopharmaceutical company focused on developing innovative product candidates targeting the treatment or prevention of a wide range of infections in hospital and non-hospital environments. Many of these infections have become increasingly difficult to treat because of the rapid increase in infectious agents that have become resistant to current drugs.

We have discovered and are developing a class of antimicrobial compounds, which we have named Aganocide compounds, that we believe could form a platform on which to create a variety of products to address differing needs in the treatment and prevention of bacterial infections. Our current development efforts are focused on Aganocide compounds to treat patients with infections of the eye, ear and sinus, to create an improved environment for the healing of wounds and to prevent infections that result from surgical or other hospital procedures, or that can be caused by the use of products, such as contact lens solutions, which can introduce an infection into the body. NVC-422 is our lead compound and forms the basis of all of our Aganocide compounds. Our in-vitro and in-vivo animal tests have demonstrated that NVC-422 kills a wide range of bacteria as well as certain yeasts, fungi and viruses very rapidly, at concentrations that are significantly lower than the concentrations at which it begins to kill human cells. We will need to conduct Phase I, II and III human clinical trials to confirm these results in order to obtain approval of NVC-422 from the U.S. Food and Drug Administration, or FDA. Often, positive in-vitro or in-vivo animal studies are not followed by positive results in human clinical trials, and we may not be able to demonstrate that our products are safe and effective for indicated uses in humans. We estimate that the clinical trials will take three to five years to conduct for each indication and will cost between $15 million and $30 million per indication. We filed an Investigational New Drug application, or IND, in March 2007 with the FDA, and began human clinical trials in May 2007.

We are also developing NVC-101 (which we also refer to as NeutroPhase), a solution containing hypochlorous acid, for use in wounds. We have conducted human safety studies under an Institutional Review Board and Phase II studies under an FDA approved IND. We have submitted a 510(k) premarketing application to the FDA to permit the use of NeutroPhase in wound management as a wound cleanser and debriding agent. We have submitted a 510(k) pre-marketing application because we believe that NeutroPhase is substantially equivalent to other approved medical devices.

Our current activities are focused on research and development of product candidates that require further development to receive regulatory approval or become commercialized products. The development and commercialization of products based on our compounds will require significantly more research, development and testing as well as governmental approvals. We intend to pursue in-house the development and commercialization of products designed to prevent selected “nosocomial” infections, or infections that originate or occur in a hospital or hospital-like setting, and to partner with leading companies to assist with the development of other products. Since the cost of developing each indication is likely to be in the range of $15 million to $30 million, we will require additional funds to complete the in-house development of multiple

 

 

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indications. In August 2006, we entered into a collaboration and licensing agreement with an affiliate of Alcon, Inc., a leading ophthalmic pharmaceutical company, to develop products incorporating Aganocide compounds for use in the eye, ear and sinus, as well as in contact lens solutions. We received $10.0 million from the Alcon affiliate in September 2006 in connection with the collaboration and licensing agreement. Other than revenues received pursuant to this agreement, we have had no revenues since our inception. We do not expect to have any revenues from sales of our drug products until 2011 or later. Until September 2006, we funded our operations through the proceeds from private placements of our preferred stock and from the exercise of warrants that had been granted to holders of our preferred stock. Our cumulative losses through March 31, 2007 were $14.0 million.

Industry Background

Combating bacterial infections is critical to modern medicine. Since the introduction of penicillin, antibiotics have greatly reduced the risks associated with bacterial infections, made possible the routine use of surgical procedures for non-critical purposes and have increased the probability of success of many modern complex operations. However, the effectiveness of available antibiotics is limited in some cases due to growing bacterial resistance and bacterial biofilm.

Bacteria are becoming resistant to different classes of antibiotics at increasing rates. These increasing levels of resistance are principally the result of repeated exposure of bacteria to non-lethal quantities of antibiotics and the ability of certain bacteria to transmit mutant genes to other bacterial species, thus enabling different species to survive the antibiotic to which the first species was exposed.

Bacterial biofilm may explain other incidences of the ineffectiveness of antibiotics. Many bacteria spend much of their existence within a matrix that they create that has been called biofilm. Encased in biofilm, bacteria are often immune to both antibiotics and white blood cells. Bacterial biofilm is associated with diseases such as sinus infections (sinusitis), ear infections, chronic wounds and infections related to cystic fibrosis. Bacterial biofilms are also frequently found on the surfaces of medical devices, such as catheters and implants, and can cause severe chronic or acute infections.

The method of delivery of most existing anti-infective drugs can also limit their effectiveness in treating bacterial infections. Most infections are localized. However, most current antibiotics used to treat bacterial infections are delivered systemically—either orally or through injection or infusion. As a result, the entire body is exposed to the antibiotic in order to treat a local infection. Furthermore, the dosage required to treat a local infection by systemic delivery is substantially higher than would be necessary if delivered locally, resulting in greater risk of toxicity which can cause adverse side effects or other harmful effects on the body.

Increasing bacterial resistance, bacterial biofilm and the limitations of traditional antibiotic therapy are major contributors to the high cost of healthcare. These problems are particularly evident in dealing with nosocomial infections, which originate or occur in a hospital or hospital-like setting, often due to the high prevalence of disease causing organisms, patients’ reduced immune systems and the exposure of patients to a variety of methods for transmitting infections.

Consequently, we believe a significant market opportunity exists to develop anti-infective products that can be delivered locally in appropriate concentrations to safely kill bacteria quickly and efficiently, whether or not they are within biofilm, and without generating resistance. If developed and approved by regulatory authorities, these products may be able to treat and prevent nosocomial infections, as well as other infections that are currently difficult to treat due to resistant bacteria and biofilm.

 

 

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Our Solution

We believe the benefits of our product candidates based upon our antimicrobial compounds may include:

 

   

Preventing or Treating Infections Caused by Resistant Bacteria . Our tests indicate that our Aganocide compounds may be effective in destroying certain types of bacteria that have become resistant to existing antibiotics.

 

   

Destroying Bacteria Protected by Biofilm . In-vitro experiments indicate that our Aganocide compounds can be effective in destroying bacteria resident in biofilm. However, we have not yet demonstrated that we can destroy bacteria in biofilms in humans.

 

   

Killing Numerous Species of Bacteria . We believe that our Aganocide compounds have the potential to be effective against most, if not all, species of bacteria. If we are able to prove this in human clinical trials, it could reduce the need to conduct diagnostic procedures to identify the bacteria causing the infection before commencing treatment.

 

   

Treating Certain Infections that May be Viral or Bacterial in Origin. We believe that our Aganocide compounds have the potential to kill not only bacteria but also some viruses, thereby permitting immediate treatment for certain diseases where the causative agent may be a bacterium or a virus. We will need to confirm that the results of preliminary non-human studies are reproducible in human clinical trials.

 

   

Reduce Nosocomial (Hospital) Infections. We believe that Aganocide compounds may be able to contribute to preventing the occurrence and the transmission of hospital infections in several ways, including in the prevention of infections associated with the use of certain medical devices, such as invasive catheters, which are a major source of hospital infections. We need to develop appropriate formulations and methods of delivery of Aganocide compounds in order to bring these products to market.

 

   

Rapidly Killing Bacteria . Our in-vitro tests indicate that our Aganocide compounds can eliminate certain bacterial colonies in minutes, whereas current therapies may take hours or days at comparable therapeutic concentrations. To be successful in the marketplace, we need to demonstrate that our product candidates can be readily usable and do not disrupt the current practices of medical care.

 

   

Reducing Toxicity and Adverse Side Effects . We believe the ability to apply our Aganocide compounds locally and in lower concentrations may reduce the risk of toxicity resulting in adverse side effects. Because Aganocide compounds are small molecules, we believe they are also less likely to elicit an immune response in the body. Although we have demonstrated that systemic absorption of our compounds is very low in animals, we need to confirm this in human studies.

 

   

Providing a High Therapeutic Index . The therapeutic index is the ratio of the concentration at which a compound kills normal cells to the concentration at which it kills bacteria. Our in-vitro testing indicates that our Aganocide compounds have a high therapeutic index in that they can kill bacteria when delivered in concentrations far below the level that will harm human cells; however we will need to conduct human clinical trials in order to confirm such safety and efficacy.

Although we have demonstrated the benefits of our antimicrobial compounds in in-vitro and in-vivo animal studies, we will need to conduct Phase I, II and III human clinical trials to confirm such results in order to obtain FDA approval of our compounds. All drug development programs are subject to substantial risk. Often, positive in-vitro or in-vivo animal studies have not been followed by positive results in human clinical trials; and we may not be able to demonstrate that our products are safe and effective for indicated uses in humans. Failure can occur at any stage of the trials, and we could encounter problems that cause us to abandon clinical trials or to repeat clinical studies or otherwise delay development of our product candidates.

 

 

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We cannot assure you that our product candidates will be safe and effective in large-scale human clinical trials. Furthermore, our compounds are intended to be direct acting and topical in delivery. We have no plans to develop them for use as oral drugs or as drugs requiring delivery by injection into the bloodstream. In order for direct-acting topical drugs to be effective, they must be delivered to the site of infection in a formulation that permits them to be effective. We have not yet demonstrated that formulations of our Aganocide compounds can be effective in humans.

Our Strategy

The key elements of our strategy include:

 

   

Developing Product Candidates In-house . We intend to develop our product candidates for selected indications for the prevention and treatment of nosocomial infections in-house, and use qualified clinical research organizations to assist us with the clinical trials. We intend to use the results of early stage clinical trials to establish the priority for development of indications and to abandon an indication where the results are inadequate.

 

   

Developing Products through to Proof-of-Concept for Multiple Indications . A major advantage of antimicrobial products is that laboratory and animal models tend to be more predictive of efficacy in humans than is often the case with other classes of drugs. We believe that this enables potential partners to evaluate our compounds much earlier than is normal for drugs in other therapeutic categories.

 

   

Licensing Indications through Partnering Arrangements with Leading Companies . We intend to pursue partnering arrangements with leading companies in cases where we expect the likely magnitude, duration and expense of the clinical trial program required to obtain approval will be substantial and beyond our internal resources. Although we have been successful in reaching an agreement with Alcon, we cannot assure you that we can obtain other similar agreements from third parties.

 

   

Broadening the Range of Aganocide Compounds . We intend to continue to synthesize further Aganocide compounds, and are currently focusing our efforts on producing additional compounds for certain specific indications in collaboration with Alcon.

Corporate Information

We were incorporated in California in January 2000 as NovaCal Pharmaceuticals, Inc. but did not commence operations until July 1, 2002 when we acquired all of the assets of NovaCal Pharmaceuticals, LLC. In February 2007, we changed our name to NovaBay Pharmaceuticals, Inc. Our principal executive offices are located at 5980 Horton Street, Suite 550, Emeryville, California 94608, and our telephone number is (510) 899-8800. NovaBay™, Aganocide™, AgaNase™ and NeutroPhase™ are our trademarks. All other trademarks and trade names appearing in this prospectus are the property of their respective owners.

Presentation of Financial Information

We present our financial statements in United States dollars, which may be referenced in this prospectus as “$,” “U.S.$,” “dollars” or “U.S. dollars”. Amounts are stated in U.S. dollars unless otherwise indicated. On May 24, 2007, the noon buying rate in New York for cable transfers payable in Canadian dollars, as certified for customs purposes by the Federal Reserve Bank of New York, was U.S.$1.00 to Cdn$1.0841.

Our financial statements included in this prospectus have been prepared in accordance with United States generally accepted accounting principles, or U.S. GAAP, which differ in certain respects from Canadian generally accepted accounting principles, or Canadian GAAP.

 

 

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The Offering

 

Common stock offered by NovaBay

             shares

 

Common stock to be outstanding after this offering

             shares

 

Use of proceeds

We currently expect to use our net proceeds from this offering as follows: approximately $5 million for the Phase I and II clinical development of NVC-422 in nasal decolonization; approximately $5 million for the pre-clinical, Phase I and initial Phase II studies of NVC-422 in the prevention of catheter associated urinary tract infections; approximately $2 million for pre-clinical studies to select among additional indications to be taken into development; and the remainder of the net proceeds for research and development, working capital and other general purposes. We may also use a portion of the net proceeds to acquire or invest in complementary businesses, services or technologies, or to enter into strategic marketing relationships with third parties. Although we currently anticipate that we will use the net proceeds of this offering as described above, there may be circumstances where, for sound business reasons, a reallocation of funds may be necessary. We may re-allocate the net proceeds from time to time depending upon the ultimate amount of net proceeds raised and upon changes in business conditions prevalent at the time. See “Use of Proceeds.”

 

Risk Factors

See “Risk Factors” and other information included in this prospectus for a discussion of factors you should carefully consider before deciding whether to purchase shares of our common stock.

 

American Stock Exchange and Toronto Stock Exchange listings

We have applied to list our shares on the American Stock Exchange (AMEX) and the Toronto Stock Exchange (TSX) under the symbol “NBY.” Any such listing will be subject to the approval of the relevant stock exchange, and any such approval will not be given unless all of the original listing requirements are met.

The number of shares of our common stock to be outstanding following this offering is based on 32,204,813 shares of our common stock outstanding at March 31, 2007, which assumes the conversion of all of our outstanding preferred stock into an aggregate of 19,227,195 shares of common stock upon the completion of this offering, and does not include, as of such date:

 

   

4.931,924 shares of common stock issuable upon exercise of options outstanding at a weighted average exercise price of $0.49 per share; and

 

   

394,750 shares of common stock reserved for future grant under our 2005 Stock Option Plan.

Unless otherwise indicated, all information in this prospectus reflects and assumes the following:

 

   

the underwriters will not exercise their over-allotment option to purchase up to              additional shares of common stock;

 

   

no other person will exercise any other outstanding options or warrants;

 

   

the initial public offering price will be $             per share, the midpoint of the range set forth on the cover page of this prospectus; and

 

   

sales will not be made to those investors for which the underwriters would receive a cash commission equal to 0.7% of the aggregate cash proceeds of such sales.

 

 

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Summary Financial Data

The following table summarizes our financial data for the periods presented. You should read this data in conjunction with the information under “Selected Financial Data” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and related notes appearing elsewhere in this prospectus. The summary financial data for the years ended December 31, 2004, 2005, and 2006 are derived from our audited financial statements. We have also included data from our unaudited financial statements for the three months ended March 31, 2006 and 2007. Our financial statements have been prepared in accordance with U.S. GAAP, which differs in certain respects from Canadian GAAP.

    

Year Ended

December 31,

   

Three Months Ended

March 31,

 
     2004     2005     2006     2006     2007  
                       (unaudited)  

Statements of Operations Data:

     (in thousands, except share and per share data)  

Revenue

   $ —       $ —       $ 1,533     $     $ 1,483  

Operating Expenses:

          

Research and development(1)

     1,481       1,952       4,087       531       1,463  

General and administrative(1)

     1,345       1,617       2,972       717       1,035  
                                        

Total operating expenses

     2,826       3,569       7,059       1,248       2,498  

Other income, net

     22       106       240       30       122  
                                        

Net loss before income taxes

     (2,804 )     (3,463 )     (5,286 )     (1,218 )     (893 )

Provision for income taxes

     —         —         —         —         —    
                                        

Net loss

   $ (2,804 )   $ (3,463 )   $ (5,286 )   $ (1,218 )   $ (893 )
                                        

Net loss per share:

          

Basic and diluted

   $ (0.32 )   $ (0.36 )   $ (0.46 )   $ (0.12 )   $ (0.07 )

Shares used in per share calculations:

          

Basic and diluted

     8,755,418       9,704,207       11,429,216       10,132,381       12,831,007  

Pro forma net loss per share (unaudited):

          

Basic and diluted

       $ (0.18 )     $ (0.03 )

Shares used in pro forma per share calculations (unaudited)(2):

          

Basic and diluted

         29,934,926         32,058,202  

          

(1)    Includes stock-based compensation expense as follows:

      

 
    

Year Ended

December 31,

   

Three Months Ended

March 31,

 
     2004     2005     2006     2006     2007  
                       (unaudited)  
     (in thousands)  

Stock-based compensation expense included above:

  

Research and development

   $ 11     $ 55     $ 86     $ 15     $ 63  

General and administrative

     —         16       281       21       175  
                                        

Total stock-based compensation expense

   $ 11     $ 71     $ 367     $ 36     $ 238  
                                        
(2) The pro forma weighted average common shares outstanding assumes the conversion of our convertible preferred stock into common stock as though the conversion had occurred on the first day of the fiscal year, or at the date of the original issuance, if later.

 

 

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The following table presents a summary of our balance sheet as of March 31, 2007:

 

   

on an actual basis, and

 

   

on a pro forma as adjusted basis to reflect the conversion into common stock of all outstanding shares of our preferred stock and the sale in this offering of              shares of our common stock at an assumed initial public offering price of $             per share, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

 

     As of March 31, 2007
     Actual    Pro Forma As
Adjusted
    

(unaudited)

     (in thousands)

Balance Sheet Data:

     

Cash, cash equivalents and short-term investments

   $ 10,053   

Working capital

     5,883   

Total assets

     11,483   

Capital lease obligation—current and non-current

     111   

Deferred revenue—current and non-current

     9,217   

Convertible preferred stock

     192   

Common stock and additional paid-in capital

     14,439   

Total stockholders’ equity

     687   

 

 

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RISK FACTORS

An investment in our common stock offered by this prospectus involves a substantial risk of loss. You should carefully consider these risk factors, together with all of the other information included in this prospectus, before you decide to purchase shares of our common stock. If any of the following risks actually occur, our business, financial condition or results of operations could be materially adversely affected, the value of our common stock could decline and you may lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair our business and operations.

Risks Related to Our Business

We are an early stage company with a history of losses. We expect to incur net losses for the foreseeable future and we may never achieve or maintain profitability.

We have incurred net losses since our inception. For the years ended December 31, 2004, 2005, and 2006 we had net losses of approximately $2.8 million, $3.5 million and $5.3 million, respectively, and for the three months ended March 31, 2007 we had a net loss of approximately $0.9 million. Through March 31, 2007, we had an accumulated deficit of approximately $14.0 million. To date, we have been, and expect to remain for the foreseeable future, mostly in a research and development stage. Since our inception, we have not generated revenue, except for modest revenue in 2006 and 2007 relating to a research and development collaboration. We have incurred substantial research and development expenses, which were approximately $1.5 million, $2.0 million and $4.1 million for the years ended December 31, 2004, 2005 and 2006, respectively, and $1.5 million for the three months ended March 31, 2007. We expect to continue to make, for at least the next several years, significant expenditures for the development of products that incorporate our Aganocide compounds, as well as continued research into the biological activities of our Aganocide compounds, which expenditures are accounted for as research and development expenses. We do not expect any of our current product candidates to be commercialized within the next several years, if at all, and we expect to continue to incur substantial losses for the foreseeable future, and we may never become profitable. We anticipate that our expenses will increase substantially in the foreseeable future as we:

 

   

conduct pre-clinical studies and clinical trials for our product candidates in different indications;

 

   

seek regulatory clearances and approvals for our product candidates;

 

   

develop, formulate, manufacture and commercialize our product candidates either independently or with partners;

 

   

pursue, acquire or in-license additional compounds, products or technologies, or expand the use of our technology;

 

   

maintain, defend and expand the scope of our intellectual property; and

 

   

hire additional qualified personnel.

We will need to generate significant revenues to achieve and maintain profitability. If we cannot successfully develop, obtain regulatory approval for and commercialize our product candidates, either independently or with partners, we will not be able to generate such revenues or achieve or maintain profitability in the future. Our failure to achieve and subsequently maintain profitability could have a material adverse impact on the market price of our common stock.

Our limited operating history may make it difficult for you to evaluate our business and to assess our future viability.

Our operations to date have been limited to organizing and staffing our company, developing our technology, researching and developing our compounds, and conducting preclinical studies and early-stage clinical trials of our compounds. We have not demonstrated the ability to succeed in achieving clinical endpoints,

 

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obtain regulatory approvals, formulate and manufacture products on a commercial scale or conduct sales and marketing activities. Consequently, any predictions you make about our future success or viability are unlikely to be as accurate as they could be if we had a longer operating history.

We have very limited data on the use of our products in humans and will need to perform costly and time consuming clinical trials in order to bring our products to market.

Most of the data that we have on our products is from in-vitro (laboratory) studies or in-vivo animal studies. We will need to conduct Phase I, II and III human clinical trials to confirm such results in order to obtain FDA approval of our compounds. Often, positive in-vitro or in-vivo animal studies are not followed by positive results in human clinical trials, and we may not be able to demonstrate that our products are safe and effective for indicated uses in humans. In addition, for each indication, we estimate that it will take between three and five years to conduct the necessary clinical trials and will cost between $15 million and $30 million.

We currently do not have any marketable products, and if we are unable to develop and obtain regulatory approval for products that we develop, we may never generate product revenues.

To date, our revenues have been derived solely from a research and development collaboration. We have never generated revenues from sales of products and we cannot guarantee that we will ever have marketable drugs or other products. Satisfaction of all regulatory requirements applicable to our product candidates typically takes many years, is dependent upon the type, complexity, novelty and classification of the product candidates, and requires the expenditure of substantial resources for research and development and testing. Before proceeding with clinical trials, we will conduct pre-clinical studies, which may, or may not be, valid predictors of potential outcomes in humans. If pre-clinical studies are favorable, we will then begin clinical trials. We must demonstrate that our product candidates satisfy rigorous standards of safety and efficacy before we can submit for and gain approval from the U.S. Food and Drug Administration, or FDA, and other regulatory authorities in the United States and in other countries. In addition, to compete effectively, our products will need to be easy to use, cost-effective and economical to manufacture on a commercial scale. We may not achieve any of these objectives. We cannot be certain that the clinical development of any of our current product candidates or any other product that we may develop in the future will be successful, that they will receive the regulatory approvals required to commercialize them, or that any of our other in-licensing efforts or pre-clinical testing will yield a product suitable for entry into clinical trials. Our commercial revenues from sales of products will be derived from sales of products that we do not expect to be commercially available for at least the next several years, if at all.

We have limited experience in developing drugs and medical devices, and we may be unable to commercialize any of the products we develop.

Development and commercialization of drugs and medical devices involves a lengthy and complex process. We have limited experience in developing products and have never received regulatory approval for, nor commercialized, any of our product candidates. In addition, no one has ever developed or commercialized a product based on our Aganocide compounds, and we cannot assure you that it is possible to develop, obtain regulatory approval for or commercialize any products based on these compounds or that we will be successful in doing so.

Before we can develop and commercialize any new products, we will need to expend significant resources to:

 

   

undertake and complete clinical trials to demonstrate the efficacy and safety of our product candidates;

 

   

maintain and expand our intellectual property rights;

 

   

obtain marketing and other approvals from the FDA and other regulatory agencies; and

 

   

select collaborative partners with suitable manufacturing and commercial capabilities.

 

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The process of developing new products takes several years. Our product development efforts may fail for many reasons, including:

 

   

the failure of our product candidates to demonstrate safety and efficacy;

 

   

the high cost of clinical trials and our lack of financial and other resources; and

 

   

our inability to partner with firms with sufficient resources to assist us in conducting clinical trials.

Success in early clinical trials often is not replicated in later studies, and few research and development projects result in commercial products. At any point, we may abandon development of a product candidate or we may be required to expend considerable resources repeating clinical trials, which would eliminate or adversely impact the timing for revenues from those product candidates. If a clinical study fails to demonstrate the safety and effectiveness of our product candidates, we may abandon the development of the product or product feature that was the subject of the clinical trial, which could harm our business.

Even if we develop products for commercial use, these products may not be accepted by the medical and pharmaceutical marketplaces or be capable of being offered at prices that will enable us to become profitable. We cannot assure you that our products will be approved by regulatory authorities or ultimately prove to be useful for commercial markets, meet applicable regulatory standards, or be successfully marketed.

We do not have our own manufacturing capacity, and we plan to rely on partnering arrangements or third-party manufacturers for the manufacture of our potential products.

We do not currently operate manufacturing facilities for clinical or commercial production of our product candidates. We have no experience in drug formulation or manufacturing, and we lack the resources and the capabilities to manufacture any of our product candidates on a clinical or commercial scale. As a result, we expect to partner with third parties to manufacture our products or rely on contract manufacturers to supply, store and distribute product supplies for our clinical trials. Any performance failure on the part of our commercial partners or future manufacturers could delay clinical development or regulatory approval of our product candidates or commercialization of our products, producing additional losses and reducing the potential for product revenues.

Our products, if developed and commercialized, will require precise, high quality manufacturing. The failure to achieve and maintain high manufacturing standards, including the incidence of manufacturing errors, could result in patient injury or death, product recalls or withdrawals, delays or failures in product testing or delivery, cost overruns or other problems that could seriously harm our business. Contract manufacturers and partners often encounter difficulties involving production yields, quality control and quality assurance, as well as shortages of qualified personnel. These manufacturers and partners are subject to ongoing periodic unannounced inspection by the FDA and corresponding state agencies to ensure strict compliance with current Good Manufacturing Practice, or GMP, and other applicable government regulations and corresponding foreign standards; however, we do not have control over third-party compliance with these regulations and standards. If any of our manufacturers or partners fails to maintain compliance, the production of our products could be interrupted, resulting in delays, additional costs and potentially lost revenues.

In addition, if the FDA or other regulatory agencies approve any of our product candidates for commercial sale, we will need to manufacture them in larger quantities. Significant scale-up of manufacturing will require validation studies, which the FDA must review and approve. If we are unable to successfully increase the manufacturing capacity for a product, the regulatory approval or commercial launch of any drugs may be delayed or there may be a shortage in supply and our business may be harmed as a result.

If we do not maintain our current research collaboration with Alcon and enter into additional collaborations, a portion of our funding may decrease and inhibit our ability to develop new products.

We have entered into a collaborative arrangement with Alcon Manufacturing Ltd. (“Alcon”), and we rely on Alcon for joint intellectual property creation and for substantially all of our near-term revenues. Under the

 

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agreement, we licensed to Alcon the exclusive rights (except for certain retained marketing rights) to develop, manufacture and commercialize products incorporating the Aganocide compounds for application in connection with the eye, ear and sinus and for use in contact lens solutions. We received a non-refundable technology access fee of $10.0 million pursuant to the agreement and are entitled to certain semi-annual payments for research and development conducted by us under the Alcon agreement for four years after the effective date of the agreement, unless Alcon elects to extend this funding term. In addition, if certain milestones are achieved in connection with the development of a product, we are entitled to receive varying milestone payments for the first achievement of each such milestone for a licensed product in each field of use. If products developed under the Alcon agreement are commercialized, we will also be entitled to receive royalty payments, which vary by field of use and whether the product is covered by a valid claim of one of our patents. We cannot assure you that our collaboration with Alcon or any other collaborative arrangement will be successful, or that we will receive the full amount of research funding, milestone payments or royalties, or that any commercially valuable intellectual property will be created, from these arrangements. If Alcon were to breach or terminate its agreement with us or otherwise fail to conduct its collaborative activities successfully and in a timely manner, the research contemplated by our collaboration with them could be delayed or terminated and our costs of performing studies may increase. We plan on entering into additional collaborations and licensing arrangements. We may not be able to negotiate additional collaborations on acceptable terms, if at all, and these collaborations may not be successful. Our current and future success depends in part on our ability to enter into successful collaboration arrangements and maintain the collaboration arrangement we currently have. If we are unable to enter into, maintain or extend successful collaborations, our business may be harmed.

We may acquire other businesses or form joint ventures or in-license compounds that could disrupt our business, harm our operating results, dilute your ownership interest in us, or cause us to incur debt or significant expense.

As part of our business strategy, we may pursue acquisitions of complementary businesses and assets, and enter into technology or pharmaceutical compound licensing arrangements. We also may pursue strategic alliances that leverage our core technology and industry experience to enhance our ability to commercialize our product candidates and expand our product offerings or distribution. We have no experience with respect to acquiring other companies and limited experience with respect to the formation of commercial partnering agreements, strategic alliances, joint ventures or in-licensing of compounds. If we make any acquisitions, we may not be able to integrate these acquisitions successfully into our existing business, and we could assume unknown or contingent liabilities. If we in-license any additional compounds, we may fail to develop the product candidates, and spend significant resources before determining whether a compound we have in-licensed will produce revenues. Any future acquisitions or in-licensing by us also could result in significant write-offs or the incurrence of debt and contingent liabilities, any of which could harm our operating results. Integration of an acquired company also may require management resources that otherwise would be available for ongoing development of our existing business. We may not identify or complete these transactions in a timely manner, on a cost-effective basis, or at all, and we may not realize the anticipated benefits of any acquisition, technology license, strategic alliance or joint venture.

To finance any acquisitions, we may choose to issue shares of our common stock as consideration, which would dilute your interest in us. If the price of our common stock is low or volatile, we may not be able to acquire other companies for stock. Alternatively, it may be necessary for us to raise additional funds for acquisitions by incurring indebtedness. Additional funds may not be available on terms that are favorable to us, or at all.

We may be unable to raise additional capital on acceptable terms in the future which may in turn limit our ability to develop and commercialize products and technologies.

We expect our capital outlays and operating expenditures to substantially increase over at least the next several years as we expand our product pipeline and increase research and development efforts and clinical and

 

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regulatory activities. Conducting clinical trials is very expensive, and we expect that we will need to raise additional capital, through future private or public equity offerings, strategic alliances or debt financing, before we achieve commercialization of any of our Aganocide compounds. In addition, we may require even more significant capital outlays and operating expenditures if we do not partner with a third party to develop and commercialize our products.

Our future capital requirements will depend on many factors, including:

 

   

the scope, rate of progress and cost of our pre-clinical studies and clinical trials and other research and development activities;

 

   

future clinical trial results;

 

   

the terms and timing of any collaborative, licensing and other arrangements that we may establish;

 

   

the cost and timing of regulatory approvals;

 

   

the cost of establishing clinical and commercial supplies of our product candidates and any products that we may develop;

 

   

the effect of competing technological and market developments;

 

   

the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; and

 

   

the extent to which we acquire or invest in businesses, products and technologies, although we currently have no commitments or agreements relating to any of these types of transactions.

We do not currently have any commitments for future external funding. Additional financing may not be available on favorable terms, or at all. Even if we succeed in selling additional securities to raise funds, our existing shareholders’ ownership percentage would be diluted and new investors may demand rights, preferences or privileges senior to those of existing shareholders. If we raise additional capital through strategic alliance and licensing arrangements, we may have to trade our rights to our technology, intellectual property or products to others on terms that may not be favorable to us. If we raise additional capital through debt financing, the financing may involve covenants that restrict our business activities.

In addition, it is often the case that the cost of pharmaceutical development can be significantly greater than initially anticipated. This may be due to any of a large number of possible reasons, some of which could have been anticipated, while others may be caused by unpredictable circumstances. A significant increase in our costs would cause the amount of financing that would be required to enable us to achieve our goals to be likewise increased.

If we determine that we need to raise additional funds and we are not successful in doing so, we may be unable to complete the clinical development of some or all of our product candidates or to seek or obtain FDA approval of our product candidates. Such events could force us to discontinue product development, enter into a relationship with a strategic partner earlier than currently intended, reduce sales and marketing efforts or forego attractive business opportunities.

We depend on skilled and experienced personnel to operate our business effectively. If we are unable to recruit, hire and retain these employees, our ability to manage and expand our business will be harmed, which would impair our future revenue and profitability.

Our success largely depends on the skills, experience and efforts of our officers, especially our chief executive officer, chief financial officer, vice-president of research and development and vice president of medical affairs, and other key employees. The efforts of each of these persons is critical to us as we continue to develop our technologies and as we attempt to transition into a company with commercial products. Any of our

 

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officers and other key employees may terminate their employment at any time. The loss of any of our senior management team members could weaken our management expertise and harm our ability to compete effectively, develop our technologies and implement our business strategies.

Our ability to retain our skilled labor force and our success in attracting and hiring new skilled employees will be a critical factor in determining whether we will be successful in the future. Our research and development programs and collaborations depend on our ability to attract and retain highly skilled scientists and technicians. We may not be able to attract or retain qualified scientists and technicians in the future due to the intense competition for qualified personnel among life science businesses, particularly in the San Francisco Bay Area. We also face competition from universities and public and private research institutions in recruiting and retaining highly qualified scientific personnel. We have also encountered difficulties in recruiting qualified personnel from outside the San Francisco Bay Area, due to the high housing costs in the area.

If we fail to manage our growth effectively, we may be unable to execute our business plan.

Our future growth, if any, may cause a significant strain on our management, and our operational, financial and other resources. Our ability to manage our growth effectively will require us to implement and improve our operational, financial and management information systems and to expand, train, manage and motivate our employees. These demands may require the hiring of additional management personnel and the development of additional expertise by management. Any increase in resources devoted to research and product development without a corresponding increase in our operational, financial and management information systems could have a material adverse effect on our business, financial condition, and results of operations.

It may be difficult to recruit and retain independent members for our Board of Directors.

The burdens being placed on the members of a board of directors by applicable laws and regulations are making it increasingly difficult to recruit qualified candidates to be members of a board of directors of a public company. These same burdens may make it increasingly difficult to retain members of our board of directors. If we are unable to maintain a board of directors in which our shareholders have confidence, this could have an adverse impact on shareholder confidence and on the price of our stock.

If our facilities become inoperable, we will be unable to perform our research and development activities, fulfill the requirements under our collaboration agreement and continue developing products and, as a result, our business will be harmed.

We do not have redundant laboratory facilities. We perform substantially all of our research, development and testing in our laboratory located in Emeryville, California. Emeryville is situated on or near active earthquake fault lines. Our facility and the equipment we use to perform our research, development and testing would be costly to replace and could require substantial lead time to repair or replace. The facility may be harmed or rendered inoperable by natural or man-made disasters, including earthquakes, flooding and power outages, which may render it difficult or impossible for us to perform our research, development and testing for some period of time. The inability to perform our research and development activities may result in the loss of partners or harm our reputation, and we may be unable to regain those partnerships in the future. Our insurance coverage for damage to our property and the disruption of our business may not be sufficient to cover all of our potential losses, including the loss of time as well as the costs of lost opportunities, and may not continue to be available to us on acceptable terms, or at all.

Obtaining regulatory approval in the United States does not ensure we will obtain regulatory approval in other countries.

We will aim to obtain regulatory approval in the United States as well as in other countries. To obtain regulatory approval to market our proposed products outside of the United States, we and any collaborator must

 

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comply with numerous and varying regulatory requirements in other countries regarding safety and efficacy. Approval procedures vary among countries and can involve additional product testing and additional administrative review periods. The time required to obtain approval in other countries might differ significantly from that required to obtain FDA approval. The regulatory approval process in other countries include all of the risk associated with FDA approval as well as additional, presently unanticipated risks. Regulatory approval in one country does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country may negatively impact the regulatory process in others. Failure to obtain regulatory approval in other countries or any delay or setback in obtaining such approval could have the same adverse effects associated with regulatory approval in the United States, including the risk that our product candidates may not be approved for all indications requested and that such approval may be subject to limitations on the indicated uses for which the product may be marketed. In addition, failure to comply with applicable regulatory requirements in other countries can result in, among other things, warning letters, fines, injunctions, civil penalties, recall or seizure of products, total or partial suspension of production, refusal of the government to renew marketing applications and criminal prosecution.

If we are unable to design, conduct and complete clinical trials successfully, we will not be able to obtain regulatory approval for our products.

In order to obtain FDA approval for some of our product candidates, we must submit to the FDA a New Drug Application, or NDA, demonstrating that the product candidate is safe and effective for its intended use. This demonstration requires significant research and animal tests, which are referred to as preclinical studies, as well as human tests, which are referred to as clinical trials.

Any clinical trials we conduct or that are conducted by our partners may not demonstrate the safety or efficacy of our product candidates. Success in pre-clinical testing and early clinical trials does not ensure that later clinical trials will be successful. Results of later clinical trials may not replicate the results of prior clinical trials and pre-clinical testing. Even if the results of one or more of our clinical trials are positive, we may have to commit substantial time and additional resources to conducting further preclinical studies or clinical trials before we can submit NDAs or obtain FDA approvals for our product candidates, and positive results of a clinical trial may not be replicated in subsequent trials.

Clinical trials are very expensive and difficult to design and implement. The clinical trial process is also time-consuming. Furthermore, if participating patients in clinical studies suffer drug-related adverse reactions during the course of such trials, or if we or the FDA believe that participating patients are being exposed to unacceptable health risks, we will have to suspend or terminate our clinical trials. Failure can occur at any stage of the trials, and we could encounter problems that cause us to abandon clinical trials or to repeat clinical studies.

In addition, the completion of clinical trials can be delayed by numerous factors, including:

 

   

delays in identifying and agreeing on acceptable terms with prospective clinical trial sites;

 

   

slower than expected rates of patient recruitment and enrollment;

 

   

increases in time required to complete monitoring of patients during or after participation in a trial; and

 

   

unexpected need for additional patient-related data.

Any of these delays, if significant, could impact the timing, approval and commercialization of our product candidates and could significantly increase our overall costs of drug development.

Even if our clinical trials are completed as planned, their results may not support our expectations or intended marketing claims. The clinical trials process may fail to demonstrate that our products are safe and effective for indicated uses. Such failure would cause us to abandon a product candidate for some indications and could delay development of other product candidates.

 

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Government agencies may establish usage guidelines that directly apply to our proposed products or change legislation or regulations to which we are subject.

Government usage guidelines typically address matters such as usage and dose, among other factors. Application of these guidelines could limit the use of products that we may develop. In addition there can be no assurance that government regulations applicable to our proposed products or the interpretation thereof will not change and thereby prevent the marketing of some or all of our products for a period of time or permanently. The FDA’s policies may change and additional government regulations may be enacted that could prevent or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature or extent of adverse government regulation that may arise from future legislation or administrative action, either in the United States or in other countries.

Our product candidates may be classified as a drug or a medical device, depending on the indication of use and prior precedent, and a change in the classification may have an adverse impact on our revenues or our ability to obtain necessary regulatory approvals.

Several potential indications for our product candidates may be regulated under the medical device regulations of the FDA administered by the Center for Devices and Radiological Health or by the Center for Drug Evaluation and Research and the same physical product may be regulated by one such agency for one indication and the other agency for another indication. Our products may be classified by the FDA as a drug or a medical device depending upon the indications for use or claims. For example, for NVC-422, if the indication is for bladder lavage, we believe it would be classified as a medical device, whereas we believe it would be considered a drug when it is indicated for the prevention of urinary tract infection. Similarly, the use of NVC-101 as a solution for cleansing and debriding wounds would be considered as a medical device. In addition, the determination as to whether a particular indication is considered a drug or a device is based in part upon prior precedent. A reclassification by the FDA of an indication from a device to a drug indication during our development for that indication could have a significant adverse impact due to the more rigorous approval process required for drugs, as compared to medical devices. Such a change in classification can significantly increase development costs and prolong the time for development and approval, thus delaying revenues. A reclassification of an indication after approval from a drug to a device could result in a change in classification for reimbursement. In many cases, reimbursement for devices is significantly lower than for drugs and there could be a significant negative impact on our revenues.

Conducting clinical trials of our product candidates may expose us to expensive liability claims, and we may not be able to maintain liability insurance on reasonable terms or at all.

The risk of clinical trial liability is inherent in the testing of pharmaceutical and medical device products. If we cannot successfully defend ourselves against any clinical trial claims, we may incur substantial liabilities or be required to limit or terminate testing of one or more of our product candidates. Our inability to obtain sufficient clinical trial insurance at an acceptable cost to protect us against potential clinical trial claims could prevent or inhibit the commercialization of our product candidates. Our current clinical trial insurance covers individual and aggregate claims up to $3 million. This insurance may not cover all claims and we may not be able to obtain additional insurance coverage at a reasonable cost, if at all, in the future. In addition, if our agreements with any future corporate collaborators entitle us to indemnification against product liability losses and clinical trial liability, such indemnification may not be available or adequate should any claim arise.

If product liability lawsuits are brought against us, they could result in costly litigation and significant liabilities.

The product candidates we are developing or attempting to develop will, in most cases, undergo extensive clinical testing and will require regulated approval from the applicable regulatory authorities prior to sale. However, despite all reasonable efforts to ensure safety, it is possible that we or our collaborators will sell

 

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products which are defective, to which patients react in an unexpected manner, or which are alleged to have side effects. The manufacture and sale of such products may expose us to potential liability, and the industries in which our products are likely to be sold have been subject to significant product liability litigation. Any claims, with or without merit, could result in costly litigation, reduced sales, significant liabilities and diversion of our management’s time and attention and could have a material adverse effect on our financial condition, business and results of operations.

If a product liability claim is brought against us, we may be required to pay legal and other expenses to defend the claim and, if the claim is successful, damage awards may not be covered, in whole or in part, by our insurance. We may not have sufficient capital resources to pay a judgment, in which case our creditors could levy against our assets. We may also be obligated to indemnify our collaborators and make payments to other parties with respect to product liability damages and claims. Defending any product liability claims, or indemnifying others against those claims, could require us to expend significant financial and managerial resources.

If we receive regulatory approval for drug products that we develop, we and our collaborators will also be subject to ongoing FDA obligations and continued regulatory review, such as continued safety reporting requirements, and we and our collaborators may also be subject to additional FDA post-marketing obligations or new regulations, all of which may result in significant expense and which may limit our ability to commercialize our potential drug products.

Any regulatory approvals that we receive for drug products that we develop may also be subject to limitations on the indicated uses for which the drug may be marketed or contain requirements for potentially costly post-marketing follow-up studies. The FDA may require us to commit to perform lengthy Phase IV post-approval studies (as further described below), for which we would have to expend additional resources, which could have an adverse effect on our operating results and financial condition. In addition, if the FDA approves any of our drug product candidates, the labeling, packaging, adverse event reporting, storage, advertising, promotion and record keeping for the drug will be subject to extensive regulatory requirements. The subsequent discovery of previously unknown problems with the drugs, including adverse events of unanticipated severity or frequency, may result in restrictions on the marketing of the drugs or the withdrawal of the drugs from the market. If we are not able to maintain regulatory compliance, we may be subject to fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution. Any of these events could prevent us from marketing any products we may develop and our business could suffer.

Failure to obtain sufficient quantities of products and substances necessary for research and development, pre-clinical trials, human clinical trials and product commercialization that are of acceptable quality at reasonable prices or at all could constrain our product development and have a material adverse effect on our business.

We have relied and will continue to rely on contract manufacturers for the foreseeable future to produce quantities of products and substances necessary for research and development, pre-clinical trials, human clinical trials and product commercialization. It will be important to us that such products and substances can be manufactured at a cost and in quantities necessary to make them commercially viable. At this point in time, we have not attempted to identify, and do not know whether there will be, any third party manufacturers which will be able to meet our needs with respect to timing, quantity and quality for commercial production. In addition, if we are unable to contract for a sufficient supply or required products and substances on acceptable terms, or if we should encounter delays or difficulties in our relationships with manufacturers, our research and development, pre-clinical and clinical testing would be delayed, thereby delaying the submission of product candidates for regulatory approval or the market introduction and subsequent sales of products. Any such delay may have a material adverse effect on our business, financial condition and results of operations.

 

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If we use biological and hazardous materials in a manner that causes injury, we could be liable for damages. Compliance with environmental regulations can be expensive, and noncompliance with these regulations may result in adverse publicity and potentially significant monetary damages and fines.

Our activities currently require the controlled use of potentially harmful biological materials and other hazardous materials and chemicals and may in the future require the use of radioactive compounds. We cannot eliminate the risk of accidental contamination or injury to employees or third parties from the use, storage, handling or disposal of these materials. In the event of contamination or injury, we could be held liable for any resulting damages, and any liability could exceed our resources or any applicable insurance coverage we may have. Additionally, we are subject, on an ongoing basis, to U.S. federal, state and local laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products. The cost of compliance with these laws and regulations might be significant and could negatively affect our operating results. In addition, if more stringent laws and regulations are adopted in the future, the costs of compliance with these new laws and regulations could be substantial or could impose significant changes in our testing and production process.

Because our clinical development activities rely heavily on sensitive and personal information, an area which is highly regulated by privacy laws, we may not be able to generate, maintain or access essential patient samples or data to continue our research and development efforts in the future on reasonable terms and conditions, which may adversely affect our business.

As a result of our clinical development, we will have access to very sensitive data regarding the patients enrolled in our clinical trials. This data will contain information that is personal in nature. The maintenance of this data is subject to certain privacy-related laws, which impose upon us administrative and financial burdens, and litigation risks. For instance, the rules promulgated by the Department of Health and Human Services under the Health Insurance Portability and Accountability Act, or HIPAA, creates national standards to protect patients’ medical records and other personal information in the United States. These rules require that healthcare providers and other covered entities obtain written authorizations from patients prior to disclosing protected health care information of the patient to companies like NovaBay. If the patient fails to execute an authorization or the authorization fails to contain all required provisions, then we will not be allowed access to the patient’s information and our research efforts can be substantially delayed. Furthermore, use of protected health information that is provided to us pursuant to a valid patient authorization is subject to the limits set forth in the authorization (i.e., for use in research and in submissions to regulatory authorities for product approvals). As such, we are required to implement policies, procedures and reasonable and appropriate security measures to protect individually identifiable health information we receive from covered entities, and to ensure such information is used only as authorized by the patient. Any violations of these rules by us could subject us to civil and criminal penalties and adverse publicity, and could harm our ability to initiate and complete clinical studies required to support regulatory applications for our proposed products. In addition, HIPAA does not replace federal, state, or other laws that may grant individuals even greater privacy protections. We can provide no assurance that future legislation will not prevent us from generating or maintaining personal data or that patients will consent to the use of their personal information, either of which may prevent us from undertaking or publishing essential research. These burdens or risks may prove too great for us to reasonably bear, and may adversely affect our ability to function profitably in the future.

We may be subject to fines, penalties, injunctions and other sanctions if we are deemed to be promoting the use of our products for non-FDA-approved, or off-label, uses.

Our business and future growth depend on the development, use and ultimate sale of products that are subject to FDA regulation, clearance and approval. Under the U.S. Federal Food, Drug, and Cosmetic Act and other laws, we are prohibited from promoting our products for off-label uses. This means that we may not make claims about the safety or effectiveness of our products and may not proactively discuss or provide information on the use of our products, except as allowed by the FDA.

 

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There is a risk that the FDA or other federal or state law enforcement authorities could determine that the nature and scope of our sales and marketing activities may constitute the promotion of our products for a non-FDA-approved use in violation of applicable law. We also face the risk that the FDA or other regulatory authorities might pursue enforcement based on past activities that we have discontinued or changed, including sales activities, arrangements with institutions and doctors, educational and training programs and other activities.

Government investigations concerning the promotion of off-label uses and related issues are typically expensive, disruptive and burdensome and generate negative publicity. If our promotional activities are found to be in violation of applicable law or if we agree to a settlement in connection with an enforcement action, we would likely face significant fines and penalties and would likely be required to substantially change our sales, promotion, grant and educational activities. In addition, were any enforcement actions against us or our senior officers to arise, we could be excluded from participation in U.S. government healthcare programs such as Medicare and Medicaid.

If we are unable to protect our intellectual property, our competitors could develop and market products similar to ours that may reduce demand for our products.

Our success, competitive position and potential future revenues will depend in significant part on our ability to protect our intellectual property. We rely on the patent, trademark, copyright and trade secret laws of the United States and other countries, as well as confidentiality and nondisclosure agreements, to protect our intellectual property rights. We apply for patents covering our technologies as we deem appropriate. We have filed trademark applications for NovaBay and Aganocide in the United States, the European Union, and Japan, and for AgaNase and NeutroPhase in the United States. We have one issued patent and five pending provisional and non-provisional applications in the United States. We also have five pending international applications filed under the Patent Cooperation Treaty, and one issued patent in Mexico, one issued patent in China, and 36 pending foreign national applications in Europe, Argentina, Australia, Brazil, Canada, China, Hong-Kong, Israel, India, Japan, South Korea, Mexico, Singapore, New Zealand and Taiwan. The subject matter of our patents and patent applications cover the following three key areas: methods relating to the manufacture and use of NVC-101, composition of matter of the Aganocide compounds and their compositions, and methods of treatment utilizing the Aganocide compounds. The issued U.S. patent expires in 2020 and provides coverage for a method of treating burns or promoting wound healing, tissue repair or tissue regeneration using a specific range of formulations of NVC-101.

We cannot assure you that patents will issue from any of our applications or, for those patents that do issue, that the claims will be sufficiently broad to protect our proprietary rights, or that it will be economically possible to pursue sufficient numbers of patents to afford significant protection. In addition, we cannot assure you that any patents issued to us or licensed or assigned to us by third parties will not be challenged, invalidated, found unenforceable or circumvented, or that the rights granted thereunder will provide competitive advantages to us. If we or our collaborators or licensors fail to file, prosecute or maintain certain patents, our competitors could market products that contain features and clinical benefits similar to those of any products we develop, and demand for our products could decline as a result. Further, although we have taken steps to protect our intellectual property and proprietary technology, we cannot assure you that third parties will not be able to design around our patents or, if they do infringe upon our technology, that we will be successful in or have sufficient resources to pursue a claim of infringement against those third parties. Any pursuit of an infringement claim by us may involve substantial expense and diversion of management attention.

We also rely on trade secrets and proprietary know-how that we seek to protect by confidentiality agreements with our employees, consultants and collaborators. We cannot assure you that these agreements will be enforceable, will not be breached, that we will have adequate remedies for any breach, or that our trade secrets and proprietary know-how will not otherwise become known or be independently discovered by competitors.

 

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In particular, we operate in the State of California and the laws of the State prevent us from imposing a delay before an employee who may have access to trade secrets and proprietary know-how can commence employment with a competing company. Although we may be able to pursue legal action against competitive companies improperly using our proprietary information, we may not be aware of any use of our trade secrets and proprietary know-how until after significant damage has been done to our company.

Furthermore, the laws of foreign countries may not protect our intellectual property rights to the same extent as the laws of the United States. If our intellectual property does not provide significant protection against foreign or domestic competition, our competitors, including generic manufacturers, could compete more directly with us, which could result in a decrease in our market share. All of these factors may harm our competitive position.

If we are unable to protect the intellectual property and market exclusivity of Aganocide compounds and products, thereby enabling other parties to commercialize competing products, our ability to generate revenues from the sale of our products may be limited or diminished.

We have filed a patent application with claims directed to the NVC-422 Aganocide compounds and claims directed to the method of using the Aganocide compounds with the United States Patent and Trademark Office, or USPTO, and a related international patent application under the Patent Cooperation Treaty, or PCT. We cannot assure you that any national or regional patents will eventually be issued from the U.S. or international patent applications. Should we be unable to obtain patents with sufficiently broad scope to protect our proprietary rights, the interest of potential partners for the development and commercialization of our Aganocide products would be greatly diminished or eliminated.

If no such patents are issued or if they are issued but are later found invalid or unenforceable or are not of sufficient scope, or after such patents expire in a given jurisdiction, our competitors may produce generic products and make them available at a cost that is cheaper than the price at which we, or our commercial partners, would offer to sell any Aganocide products we develop.

We have also filed a patent application claiming various derivatives and analogs of NVC-422 Aganocide compounds and their method of use with the USPTO as well as a corresponding PCT application. If our efforts to protect the intellectual property and market position of the NVC-422 Aganocide products and their methods of use do not succeed, our ability to generate revenues from the sale of any such products may be limited or diminished.

However, we do not have any composition of matter patent directed to the NVC-101 composition. If a potential competitor introduces a similar method of using NVC-101 with a similar composition that does not fall within the scope of the method of treatment claims, then we or a potential marketing partner would be unable to rely on the allowed claims to protect its market position for the method of using the NVC-101 composition, and any revenues arising from such protection would be adversely impacted.

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

Some of our employees may have been previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although no claims against us are currently pending, we may be subject to claims that these employees or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management. If we fail in defending such claims, in addition to paying money damages, we may lose valuable intellectual property rights or personnel. A loss of key research personnel or their work product could hamper or prevent our ability to commercialize product candidates, which could severely harm our business.

 

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The pharmaceutical and biopharmaceutical industries are characterized by patent litigation and any litigation or claim against us may cause us to incur substantial costs, and could place a significant strain on our financial resources, divert the attention of management from our business and harm our reputation.

There has been substantial litigation in the pharmaceutical and biopharmaceutical industries with respect to the manufacture, use and sale of new products that are the subject of conflicting patent rights. For the most part, these lawsuits relate to the validity, enforceability and infringement of patents. Generic companies are encouraged to challenge the patents of pharmaceutical products in the United States because a successful challenger can obtain six months of exclusivity as a generic product under the Waxman-Hatch Act. We expect that we will rely upon patents, trade secrets, know-how, continuing technological innovations and licensing opportunities to develop and maintain our competitive position and we may initiate claims to defend our intellectual property rights as a result. Other parties may have issued patents or be issued patents that may prevent the sale of our products or know-how or require us to license such patents and pay significant fees or royalties in order to produce our products. In addition, future patents may issue to third parties which our technology may infringe. Because patent applications can take many years to issue, there may be applications now pending of which we are unaware that may later result in issued patents that our products may infringe.

Intellectual property litigation, regardless of outcome, is expensive and time-consuming, could divert management’s attention from our business and have a material negative effect on our business, operating results or financial condition. If such a dispute were to be resolved against us, we may be required to pay substantial damages, including treble damages and attorneys fees if we were to be found to have willfully infringed a third party’s patent, to the party claiming infringement, develop non-infringing technology, stop selling any products we develop, cease using technology that contains the allegedly infringing intellectual property or enter into royalty or license agreements that may not be available on acceptable or commercially practical terms, if at all. Our failure to develop non-infringing technologies or license the proprietary rights on a timely basis could harm our business. Modification of any products we develop or development of new products thereafter could require us to conduct additional clinical trials and to revise our filings with the FDA and other regulatory bodies, which would be time- consuming and expensive. In addition, parties making infringement claims may be able to obtain an injunction that would prevent us from selling any products we develop, which could harm our business.

If bacteria develop resistance to Aganocide compounds, our revenues could be significantly reduced.

Based on our understanding of the hypothesis of the mechanism of action of our Aganocide compounds, we do not expect bacteria to be able to develop resistance to Aganocide compounds. However, we cannot assure you that one or more strains of bacteria will not develop resistance to our compounds, either because our hypothesis of the mechanism of action is incorrect or because a strain of bacteria undergoes some unforeseen genetic mutation that permits it to survive. Since we expect lack of resistance to be a major factor in the commercialization of our product candidates, the discovery of such resistance would have a major adverse impact on the acceptability and sales of our products.

If physicians and patients do not accept and use our products, we will not achieve sufficient product revenues and our business will suffer.

Even if the FDA approves any product candidates that we develop, physicians and patients may not accept and use them. Acceptance and use of our products may depend on a number of factors including:

 

   

perceptions by members of the healthcare community, including physicians, about the safety and effectiveness of our products;

 

   

published studies demonstrating the cost-effectiveness of our products relative to competing products;

 

   

availability of reimbursement for our products from government or healthcare payers; and

 

   

effectiveness of marketing and distribution efforts by us and our licensees and distributors, if any.

 

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The failure of any of our products to find market acceptance would harm our business and could require us to seek additional financing.

If we are unable to develop our own sales, marketing and distribution capabilities, or if we are not successful in contracting with third parties for these services on favorable terms, or at all, revenues from any products we develop could be disappointing.

We currently have no internal sales, marketing or distribution capabilities. In order to commercialize any product candidates approved by the FDA, we will either have to develop such capabilities internally or collaborate with third parties who can perform these services for us. If we decide to commercialize any products we develop, we may not be able to hire the necessary experienced personnel and build sales, marketing and distribution operations which are capable of successfully launching new products and generating sufficient product revenues. In addition, establishing such operations will take time and involve significant expense.

If we decide to enter into co-promotion or other licensing arrangements with third parties, we may be unable to identify acceptable partners because the number of potential partners is limited and because of competition from others for similar alliances with potential partners. Even if we are able to identify one or more acceptable partners, we may not be able to enter into any partnering arrangements on favorable terms, or at all. If we enter into any partnering arrangements, our revenues are likely to be lower than if we marketed and sold our products ourselves.

In addition, any revenues we receive would depend upon our partners’ efforts which may not be adequate due to lack of attention or resource commitments, management turnover, change of strategic focus, further business combinations or other factors outside of our control. Depending upon the terms of our agreements, the remedies we have against an under-performing partner may be limited. If we were to terminate the relationship, it may be difficult or impossible to find a replacement partner on acceptable terms, or at all.

If we cannot compete successfully for market share against other companies, we may not achieve sufficient product revenues and our business will suffer.

The market for our product candidates is characterized by intense competition and rapid technological advances. If our product candidates receive FDA approval, they will compete with a number of existing and future drugs, devices and therapies developed, manufactured and marketed by others. Existing or future competing products may provide greater therapeutic convenience or clinical or other benefits for a specific indication than our products, or may offer comparable performance at a lower cost. If our products are unable to capture and maintain market share, we may not achieve sufficient product revenues and our business will suffer.

We will compete for market share against fully integrated pharmaceutical companies or other companies that develop products independently or collaborate with larger pharmaceutical companies, academic institutions, government agencies and other public and private research organizations. In addition, many of these competitors, either alone or together with their collaborative partners, have substantially greater capital resources, larger research and development staffs and facilities, and greater financial resources than we do, as well as significantly greater experience in:

 

   

developing drugs and devices;

 

   

conducting preclinical testing and human clinical trials;

 

   

obtaining FDA and other regulatory approvals of product candidates;

 

   

formulating and manufacturing products; and

 

   

launching, marketing, distributing and selling products.

 

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Our competitors may:

 

   

develop and patent processes or products earlier than we will;

 

   

develop and commercialize products that are less expensive or more efficient than any products that we may develop;

 

   

obtain regulatory approvals for competing products more rapidly than we will; and

 

   

improve upon existing technological approaches or develop new or different approaches that render any technology or products we develop obsolete or uncompetitive.

We cannot assure you that our competitors will not succeed in developing technologies and products that are more effective than any developed by us or that would render our technologies and any products we develop obsolete. If we are unable to compete successfully against current or future competitors, we may be unable to obtain market acceptance for any product candidates that we create, which could prevent us from generating revenues or achieving profitability and could cause the market price of our common stock to decline.

Our ability to generate revenues from any products we develop will be diminished if we fail to obtain acceptable prices or an adequate level of reimbursement for our products from healthcare payers.

Our ability to commercialize our product candidates will depend, in part, on the extent to which health insurers, government authorities and other third-party payers will reimburse the costs of products which may be developed by us or our partners. We expect that a portion of our economic return from partnering arrangements with pharmaceutical companies and other collaborators will be derived from royalties, fees or other revenues linked to final sales of products that we or our partners develop. Newly-approved pharmaceuticals and other products which are developed by us or our partners will not necessarily be reimbursed by third-party payers or may not be reimbursed at levels sufficient to generate significant sales. Government and other third-party payers are increasingly attempting to contain health care costs by limiting both coverage and the level of reimbursement for new drugs or medical devices. Cost control initiatives such as these could adversely affect our or our collaborators’ ability to commercialize products. In addition, real or anticipated cost control initiatives for final products may reduce the willingness of pharmaceutical companies or other potential partners to collaborate with us on the development of new products.

Significant uncertainty exists as to the reimbursement status of newly-approved healthcare products. Healthcare payers, including Medicare, health maintenance organizations and managed care organizations, are challenging the prices charged for medical products or are seeking pharmacoeconomic data to justify formulary acceptance and reimbursement practices. We currently have not generated pharmacoeconomic data on any of our product candidates. Government and other healthcare payers increasingly are attempting to contain healthcare costs by limiting both coverage and the level of reimbursement for drugs and medical devices, and by refusing, in some cases, to provide coverage for uses of approved products for disease indications for which the FDA has or has not granted labeling approval. Adequate third-party insurance coverage may not be available to patients for any products we discover and develop, alone or with collaborators. If government and other healthcare payers do not provide adequate coverage and reimbursement levels for our products, market acceptance of our product candidates could be limited.

A significant terrorist attack or threat of such attack may adversely impact our ability to obtain financing.

A major terrorist attack, the threat of such attack or other unforeseen events beyond our control, may occur at a time when we need to raise additional financing. Closure or severe perturbation of the financial markets as a result of such events may make such financing impossible or unattractive and our plans may be seriously disrupted. As a consequence, the progress of the company towards revenues or profits could be significantly impaired.

 

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Risks Related to This Offering and Ownership of Our Common Stock

Our common stock has not been publicly traded, and we expect that the price of our common stock will fluctuate substantially.

Before this offering, there has been no public market for our common stock. We intend to apply to list our shares on the Toronto Stock Exchange and the American Stock Exchange. Any such listing will be subject to the approval of the relevant stock exchange, and any such approval will not be given unless all of the original listing requirements are met. An active public trading market for our common stock may not develop after completion of this offering or, if developed, may not be sustained. If an active public market does not develop or is not maintained, you may have difficulty selling your shares. The initial public offering price of our shares was determined by negotiations between us and the underwriters for this offering and may not be indicative of the price at which our common stock will trade following the completion of this offering. We cannot assure you that the market price of our common stock will not materially decline below the initial public offering price. The market price for our common stock after this offering will be affected by a number of factors, including:

 

   

the results of preclinical or clinical trials relating to our product candidates;

 

   

the announcement of new products by us or our competitors;

 

   

announcement of partnering arrangements by us or our competitors;

 

   

quarterly variations in our or our competitors’ results of operations;

 

   

announcements by us related to litigation;

 

   

changes in our earnings estimates, investors’ perceptions, recommendations by securities analysts or our failure to achieve analysts’ earning estimates;

 

   

developments in our industry; and

 

   

general market conditions and other factors unrelated to our operating performance or the operating performance of our competitors.

The stock prices of many companies in the pharmaceutical and biotechnology industry have experienced wide fluctuations that have often been unrelated to the operating performance of those companies. These factors and price fluctuations may also materially and adversely affect the market price of our common stock.

We must implement additional and expensive finance and accounting systems, procedures and controls in order to grow our business and organization and to satisfy new reporting requirements, which will increase our costs and require additional management resources.

As a public reporting company, we will be required to comply with the Sarbanes-Oxley Act of 2002 and the related rules and regulations of the Securities and Exchange Commission, or SEC, and Canadian securities regulatory authorities, including expanded disclosures and accelerated reporting requirements and more complex accounting rules. Upon approval for listing as a public company on the TSX and on AMEX, we will also be required to comply with marketplace rules and the heightened corporate governance standards of the TSX and AMEX. Compliance with Section 404 of the Sarbanes-Oxley Act of 2002, which will be required by 2009, and other requirements of the SEC, Canadian securities regulatory authorities, AMEX and the TSX will increase our costs and require additional management resources. We recently have begun upgrading our finance and accounting systems, procedures and controls and will need to continue to implement additional finance and accounting systems, procedures and controls as we grow our business and organization and to satisfy new reporting requirements. If we are unable to complete the required Section 404 assessment as to the adequacy of our internal control over financial reporting, if we fail to maintain or implement adequate controls, or if our independent registered public accounting firm is unable to provide us with an unqualified report as to the effectiveness of our internal control over financial reporting as of the date of the first Annual Report on Form 10-K for which compliance is required, our ability to obtain additional financing could be impaired. In addition, investors could lose confidence in the reliability of our internal control over financial reporting

 

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and in the accuracy of our periodic reports filed with the SEC and with Canadian securities regulatory authorities. A lack of investor confidence in the reliability and accuracy of our public reporting could cause our stock price to decline.

The volume of trading of our common stock may be low, leaving our common stock open to risk of high volatility.

The number of shares of our common stock being traded may be very low. Any shareholder wishing to sell his/her stock may cause a significant fluctuation in the price of our stock. In addition, low trading volume of a stock increases the possibility that, despite rules against such activity, the price of the stock may be manipulated by persons acting in their own self-interest. We may not have adequate market makers and market making activity to prevent manipulation.

New investors in our common stock will experience immediate and substantial dilution in the book value of their investment after this offering.

The initial public offering price of our common stock is substantially higher than the book value per share of our common stock. If you purchase common stock in this offering, you will incur immediate dilution of $              in the pro forma net tangible book value per share of common stock, based on an initial public offering price of $              per share. In addition, 32,204,813 shares of common stock were outstanding as of March 31, 2007, which assumes the conversion of all of our outstanding preferred stock into an aggregate of 19,227,195 shares of common stock on the completion of this offering, and an additional              shares will be reserved for issuance under our stock option plans as of the date of this prospectus. Investors will incur additional dilution upon the exercise of stock options. For a further description of the effects of dilution in the net tangible book value of our common stock, see “Dilution.”

Future sales of shares by our shareholders could cause the market price of our common stock to drop significantly, even if our business is doing well.

After this offering, we will have outstanding              shares of common stock based on the number of shares outstanding at             . This includes the              shares we are selling in this offering, which may be resold in the public market immediately. In addition,              shares outstanding as of March 31, 2007, which shares were issued by us prior to                         , 2005, will be available for immediate sale in the public market as of the date of this prospectus. Following the expiration of, or release from, lock-up agreements with the representatives of the underwriters and applicable Canadian escrow requirements,              additional shares will become available for sale in the public market six months after the closing of this offering, subject in some cases to compliance with the volume and other limitations of Rule 144 and in other cases subject to compliance with applicable Canadian requirements. Thereafter,             additional shares held by our officers and directors will become eligible for sale in the public market over the three to 18 month period following the initial six month lock-up period, as the shares are released from the lock-up agreements with the representatives of the underwriters and applicable Canadian escrow requirements.

In addition, at any time and without public notice, the underwriters may in their sole discretion release all or some of the securities subject to the lock-up agreements subject to applicable regulatory requirements. As restrictions on resale end, the market price of our stock could drop significantly if the holders of those shares sell them or are perceived by the market as intending to sell them. These declines in our stock price could occur even if our business is otherwise doing well.

Our directors, officers and principal shareholders have significant voting power and may take actions that may not be in the best interests of our other shareholders.

After this offering, our officers and directors collectively will control approximately      % of our outstanding common stock, without giving effect to the purchase of shares by any such persons in this offering. Furthermore, our largest shareholder, a family trust established and controlled by Dr. Najafi, our Chairman and

 

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Chief Executive Officer, will beneficially own      % of our outstanding common stock after giving effect to this offering, assuming no additional purchases of shares in this offering by Dr. Najafi, the trust or persons affiliated with them. As a result, Dr. Najafi can significantly influence the management and affairs of our Company and most matters requiring shareholder approval, including the election of directors and approval of significant corporate transactions. This concentration of ownership may have the effect of delaying or preventing a change in control and might adversely affect the market price of our common stock. This concentration of ownership may not be in the best interests of our other shareholders.

We have broad discretion in the use of proceeds of this offering for working capital and general corporate purposes.

We expect to spend the net proceeds that we will receive from this offering on advancement of the clinical development of our Aganocide compounds, research and development, working capital, general corporate purposes, and potential acquisitions of other complementary businesses, products or technologies. Within those categories, we have not determined the specific allocation of the net proceeds of this offering. Our management will have broad discretion over the use and investment of the net proceeds of this offering within those categories, and accordingly investors in this offering will need to rely upon the judgment of our management with respect to the use of proceeds, with only limited information concerning management’s specific intentions.

Our amended and restated articles of incorporation and bylaws and California law, contain provisions that could discourage a third party from making a takeover offer that is beneficial to our shareholders.

Anti-takeover provisions of our amended and restated articles of incorporation, amended and restated bylaws and California law may have the effect of deterring or delaying attempts by our shareholders to remove or replace management, engage in proxy contests and effect changes in control. The provisions of our charter documents will include:

 

   

a classified board so that only one of the three classes of directors on our Board of Directors is elected each year;

 

   

elimination of cumulative voting in the election of directors;

 

   

procedures for advance notification of shareholder nominations and proposals;

 

   

the ability of our Board of Directors to amend our bylaws without shareholder approval; and

 

   

the ability of our Board of Directors to issue up to 5,000,000 shares of preferred stock without shareholder approval upon the terms and conditions and with the rights, privileges and preferences as our Board of Directors may determine.

In addition, as a California corporation, we are subject to California law, which includes provisions that may have the effect of deterring hostile takeovers or delaying or preventing changes in control or management of NovaBay. Provisions of the California Corporations Code could make it more difficult for a third party to acquire a majority of our outstanding voting stock by discouraging a hostile bid, or delaying, preventing or deterring a merger, acquisition or tender offer in which our shareholders could receive a premium for their shares, or effect a proxy contest for control of NovaBay or other changes in our management.

We have not paid dividends in the past and do not expect to pay dividends in the future, and any return on investment may be limited to the value of our stock.

We have never paid cash dividends on our common stock and do not anticipate paying cash dividends on our common stock in the foreseeable future. The payment of dividends on our common stock will depend on our earnings, financial condition and other business and economic factors affecting us at such time as our Board of Directors may consider relevant. If we do not pay dividends, you will experience a return on your investment in

 

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our shares only if our stock price appreciates. We cannot assure you that you will receive a return on your investment when you do sell your shares or that you will not lose the entire amount of your investment.

We may be considered a “foreign investment entity” which may have adverse Canadian tax consequences for our Canadian investors.

Although we believe that we are not currently a “foreign investment entity” within the meaning of the FIE Tax Proposals (as defined in “Material Canadian Federal Income Tax Considerations—Foreign Investment Entity Status”), no assurances can be given in this regard or as to the Company’s status in the future. If the Company becomes a “foreign investment entity” within the meaning of the FIE Tax Proposals, there may be certain adverse tax consequences for our Canadian investors. See “Material Canadian Federal Income Tax Considerations—Foreign Investment Entity Status”.

Because we are a California corporation and the majority of our directors and officers are resident in the United States, it may be difficult for investors in Canada to enforce against us certain civil liabilities and judgments based solely upon the securities laws of Canada.

We are organized under the laws of California and our principal executive offices are located in California. A majority of the directors and officers and the experts named in this prospectus reside principally in the United States and all or a substantial portion of their assets and all or a substantial portion of our assets are located in the United States. Consequently, it may be difficult for shareholders to effect service of process within Canada upon us or our directors, officers or experts who are residents of the United States. Furthermore, it may not be possible to enforce against us or such directors, officers or experts, in the United States, judgments obtained in Canadian courts, including judgments based upon the civil liability provisions of applicable Canadian securities law.

 

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains forward-looking statements that are based on our management’s current beliefs and assumptions and on information currently available to our management. The forward-looking statements are contained principally in the sections entitled “Prospectus Summary,” “Risk Factors,” “Use of Proceeds,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business.” In some cases, you can identify forward-looking statements by terms such as “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” and similar expressions intended to identify forward-looking statements. Forward-looking statements include but are not limited to, statements about:

 

   

The efficacy and safety of our product candidates;

 

   

The timing of clinical development of our product candidates;

 

   

The expected characteristics of Aganocide compounds and our ability to demonstrate those characteristics;

 

   

The outcome or success of pre-clinical studies and clinical trials;

 

   

Our expectation regarding federal, state and foreign (including Canadian provincial) regulatory requirements;

 

   

Allocation of resources for the purposes of bringing our proposed products to market;

 

   

The amount of research and development expenses we expect to incur;

 

   

Our ability to develop third-party partnerships;

 

   

Our expectations regarding the use of proceeds from this offering;

 

   

Our plans to in-license products to address new markets;

 

   

Strategies to strengthen our intellectual property protection for our compounds and proposed products; and

 

   

Anticipated trends and challenges in our business and the markets in which we operate.

Forward-looking statements involve a variety of known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. We discuss many of these risks in this prospectus in greater detail under the heading “Risk Factors.” Given these uncertainties, you should not place undue reliance on these forward-looking statements. You should read this prospectus and the documents that we reference in this prospectus and have filed as exhibits to the registration statement for the shares in this offering completely and with the understanding that our actual future results may be materially different from what we expect.

The forward-looking statements made in this prospectus relate only to events or information as of the date on which the statements are made in this prospectus. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

 

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USE OF PROCEEDS

We estimate that the net proceeds from the sale of              shares of common stock that we are selling in this offering will be approximately $            million, based on an assumed initial public offering price of $             per share, after deducting underwriting discounts and commissions and estimated offering expenses. If the underwriters’ over-allotment option is exercised in full, we estimate that we will receive net proceeds of approximately $             million, after deducting underwriting discounts and commissions and estimated offering expenses.

We currently expect to use our net proceeds from this offering as follows:

 

   

approximately $5 million for the Phase I and II clinical development of NVC-422 in nasal decolonization;

 

   

approximately $5 million for the pre-clinical, Phase I and initial Phase II studies of NVC-422 in the prevention of catheter associated urinary tract infections;

 

   

approximately $2 million for pre-clinical studies to select among additional indications to be taken into development; and

 

   

the remainder of the net proceeds for research and development, working capital and other general purposes.

We may also use a portion of the net proceeds to acquire or invest in complementary businesses, services or technologies, or to enter into strategic marketing relationships with third parties, but we have no current understandings, commitments or agreements to do so. From time to time, in the ordinary course of business, we expect to evaluate potential acquisitions of or investments in these businesses, services or technologies and strategic relationships.

Although we currently anticipate that we will use the net proceeds of this offering as described above, there may be circumstances where for sound business reasons, a reallocation of funds may be necessary. We may re-allocate the net proceeds from time to time depending upon the ultimate amount of net proceeds raised and upon changes in business conditions prevalent at the time. The timing and amount of our actual expenditures will be based on many factors, including the successful early clinical development of our lead product candidates, cash flows from operations and the anticipated growth of our business. Pending these uses, we intend to invest the net proceeds of this offering primarily in short-term, investment-grade, interest-bearing instruments.

We will require additional funds to complete the nasal decolonization and urinary tract programs to an NDA (New Drug Application) filing with regulatory authorities and for the initiation of at least two additional programs. We estimate that the clinical development of each indication will cost between $15 million and $30 million and will take between three and five years.

DIVIDEND POLICY

We have never declared or paid any cash dividends on our common stock. We currently intend to retain any future earnings to finance the growth and development of our business. Therefore, we do not anticipate that we will declare or pay any cash dividends on our common stock in the foreseeable future. Any future determination to pay cash dividends will be at the discretion of our Board of Directors and will be dependent upon our financial condition, results of operations, capital requirements, restrictions under any existing indebtedness and other factors the Board of Directors deems relevant.

 

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CAPITALIZATION

The following table sets forth our cash, cash equivalents, and capitalization at March 31, 2007, as follows:

 

   

on an actual basis;

 

   

on a pro forma basis after giving effect to the conversion of all outstanding shares of our preferred stock into an aggregate of 19,227,195 shares of our common stock upon the closing of this offering; and

 

   

on a pro forma as adjusted basis after giving effect to (a) the conversion of all outstanding shares of our preferred stock into an aggregate of 19,227,195 shares of our common stock upon the closing of this offering and (b) the issuance of              shares of our common stock at an assumed initial public offering price of $             per share, after deducting underwriting discounts and commissions and estimated offering expenses payable by us.

You should read this table in conjunction with the sections titled “Selected Financial Data” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and related notes included elsewhere in this prospectus.

 

     March 31, 2007
       Actual     Pro Forma     Pro Forma
As Adjusted
     (unaudited)
    

(in thousands, except share and per
share data)

Cash, cash equivalents and short-term investments

   $ 10,053     $ 10,053     $             
                      

Stockholders’ equity:

      

Convertible preferred stock, $0.01 par value: 39,000,000 shares authorized; 19,227,195 shares issued and outstanding, actual; no shares, issued and outstanding, pro forma and pro forma as adjusted

   $ 192     $ —       $             

Common stock, $0.01 par value: 64,000,000 shares authorized; 12,622,618 shares issued and outstanding, actual; 31,849,813 shares issued and outstanding, pro forma;                  shares issued and outstanding, pro forma as adjusted

     130       322    

Additional paid-in capital

     14,309       14,309    

Accumulated other comprehensive income

     23       23    

Accumulated deficit during development stage

     (13,967 )     (13,967 )  
                      

Total stockholders’ equity

     687       687    
                      

Total capitalization

   $ 687     $ 687     $             
                      

The above table excludes, as of March 31, 2007:

 

   

4,931,924 shares of common stock issuable upon exercise of outstanding options at a weighted average exercise price of $0.49 per share; and

 

   

394,750 shares of common stock reserved for future grant under our 2005 Stock Option Plan.

For additional information regarding our capital structure, see “Management—Employee Benefit Plans,” “Description of Capital Stock” and Note 8 to the financial statements.

The pro forma as adjusted information above is illustrative only, and our capitalization following the completion of this offering is subject to adjustment based on the actual initial public offering price of our shares and other terms of this offering to be determined at pricing. Each $1.00 increase (decrease) in the assumed initial offering price per share would increase (decrease) each of cash and cash equivalents, total group equity and total capitalization by approximately $             million.

 

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DILUTION

Investors participating in this offering will incur immediate, substantial dilution to the extent of the difference between the initial public offering price per share of our common stock and the pro forma net tangible book value per share upon the completion of this offering. Our pro forma net tangible book value as of March 31, 2007 was $0.7 million, or $0.02 per share of common stock. The pro forma net tangible book value per share represents our total tangible assets less total liabilities divided by the number of shares of common stock outstanding as of March 31, 2007 (after giving effect to the conversion of all outstanding shares of preferred stock into shares of common stock upon completion of this offering).

Net tangible book value dilution per share to new investors represents the difference between the amount per share paid by purchasers of shares of common stock in this offering and the pro forma net tangible book value per share of common stock immediately after completion of this offering. After giving effect to our sale of              shares of common stock in this offering at an assumed initial public offering price of $             per share and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us, our pro forma net tangible book value as of March 31, 2007 would have been $             million, or $             per share. This represents an immediate increase in net tangible book value of $             per share to existing shareholders and an immediate dilution in net tangible book value of $             per share to purchasers of common stock in this offering, as illustrated in the following table:

 

Assumed initial public offering price per share

      $             

Pro forma net tangible book value per share as of March 31, 2007

   $ 0.02   

Increase per share attributable to new investors

     
         

Pro forma as adjusted net tangible book value per share after this offering

     
         

Dilution per share to new investors in this offering

      $             
         

The pro forma as adjusted information discussed above is illustrative only. Our pro forma net tangible book value following the completion of this offering is subject to adjustment based on the actual initial public offering price of our shares and other terms of this offering determined at pricing. A $1.00 increase (decrease) in the assumed initial public offering price of $             per share would increase (decrease) total consideration paid by new investors, total consideration paid by all shareholders and the average price per share paid by all shareholders by $             million, $             million and $            , respectively, and would increase (decrease) the pro forma as adjusted net tangible book value per share after giving effect to this offering by $             per share and increase (decrease) dilution in pro forma as adjusted net tangible book value per share to new investors in this offering by $             per share, in each case assuming no change in the number of shares sold by us as set forth on the cover page of this prospectus and without deducting underwriting commissions and other estimated expenses of the offering payable by us. Furthermore, upon the completion of this offering, we expect that an additional              shares of our common stock will be issuable, subject to vesting, under outstanding stock options. If all of these options were exercised immediately upon the completion of this offering, then based on the assumed initial public offering price in the table above, our pro forma net tangible book value per share as of March 31, 2007 would be $            , the increase in our pro forma net tangible book value per share attributable to this offering would be $            , our pro forma as adjusted net tangible book value per share after this offering would be $            , and the dilution per share to new investors would be $            .

The following table presents on a pro forma basis as of March 31, 2007, after giving effect to the conversion of all outstanding shares of preferred stock into common stock upon completion of this offering, the differences between the existing shareholders and the purchasers of shares in this offering with respect to the number of shares purchased from us, the total consideration paid and the average price paid per share, assuming an initial public offering price of $             per share, the midpoint of the estimated range of the initial public offering price set forth on the cover page of this prospectus. The information in the following table is illustrative only and the

 

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total consideration paid and the average price per share is subject to adjustment based on the actual initial public offering price of our shares of common stock.

 

     Shares Purchased     Total Consideration    

Average
Price Per

Share

     Number    Percent     Amount    Percent    

Existing shareholders

   32,204,813        .   %   $                     .   %   $             

New shareholders

            
                          

Total

      100.0 %   $                 100.0 %  
                          

As of March 31, 2007, there were options outstanding to purchase an aggregate of 4,931,924 shares of our common stock at a weighted average exercise price of $0.49 per share. The foregoing discussion and tables assume no exercise of any stock options outstanding as of March 31, 2007. To the extent that these options are exercised, new investors will experience further dilution. If all of the options outstanding upon the completion of this offering were exercised immediately upon the completion of this offering, the number of shares purchased by existing shareholders and new investors would be             , or     %, and             , or     %, respectively; total consideration paid by existing shareholders and new investors would be $            , or     %, and $            , or     %, respectively; and the average price per share paid by existing shareholders and new investors would be $            , or     %, and $            , or     %, respectively.

If the underwriters exercise their over-allotment option in full, the number of shares held by new investors will increase to             , or      % of the total shares outstanding after this offering, our pro forma as adjusted net tangible book value per share would continue to be $            , and the dilution per share would be $            .

 

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SELECTED FINANCIAL DATA

The selected statement of operations data for the years ended December 31, 2004, 2005 and 2006 and the selected balance sheet data as of December 31, 2005 and 2006 are derived from our audited financial statements, which are included elsewhere in this prospectus. The selected statement of operations data for the year ended December 31, 2003 and for the period from July 1, 2002 to December 31, 2002 and the selected balance sheet data as of December 31, 2002, 2003 and 2004 are derived from our audited financial statements and the related notes which are not included in this prospectus. The selected statement of operations data for the period from January 1, 2002 to June 30, 2002 are derived from the unaudited financial statements of NovaCal Pharmaceuticals, LLC (“LLC”), our predecessor company. We acquired all of the operating assets of the LLC on July 1, 2002 in a transaction that was accounted for using the purchase method of accounting. The selected statements of operations data for the three months ended March 31, 2006 and 2007 and the selected balance sheet data as of March 31, 2007 have been derived from our unaudited financial statements, which are included elsewhere in this prospectus. The unaudited financial statements have been prepared on a basis consistent with our audited financial statements and, in the opinion of management, include all adjustments that management considers necessary for fair presentation of the information for the unaudited periods. Our financial statements have been prepared in accordance with U.S. GAAP, which differs in certain respects from Canadian GAAP. You should read the following selected financial data in conjunction with “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the financial statements, related notes and other financial information included in this prospectus. The selected financial data is not intended to replace the financial statements. See Note 12 to our financial statements for an explanation of the method used to determine the number of shares used in computing net loss per share amounts.

 

   

NovaCal

Pharmaceuticals,
LLC

    NovaBay Pharmaceuticals, Inc.  
   

Period from

Jan 1,

2002 to

June 30,

2002

    Period from
July 1,
2002 to
December 31,
2002
   

Year Ended

December 31,

   

Three Months
Ended

March 31,

 
        2003     2004     2005     2006     2006     2007  
    (unaudited)                                   (unaudited)  
    (in thousands, except per share data)  

Statements of Operations Data:

               

Revenue

  $ —       $ —       $ —       $ —       $ —       $ 1,533     $ —       $ 1,483  

Operating Expenses:

               

Research and development(1)

    139       201       270       1,481       1,952       4,087       531       1,463  

General and administrative(1)

    150       343       683       1,345       1,617       2,972       717       1,035  
                                                               

Total operating expenses

    289       544       953       2,826       3,569       7,059       1,248       2,498  

Other income (expense), net

    2       —         (24 )     22       106       240       30       122  
                                                               

Net loss before income taxes

    (287 )     (544 )     (977 )     (2,804 )     (3,463 )     (5,286 )     (1,218 )     (893 )

Provision for income taxes

    —         —         —         —         —         —         —         —    
                                                               

Net loss

  $ (287 )   $ (544 )   $ (977 )   $ (2,804 )   $ (3,463 )   $ (5,286 )   $ (1,218 )   $ (893 )
                                                               

Net loss per share:

               

Basic and diluted

  $ (0.04 )   $ (0.07 )   $ (0.12 )   $ (0.32 )   $ (0.36 )   $ (0.46 )   $ (0.12 )   $ (0.07 )

Shares used in per share calculations:

               

Basic and diluted

    7,634       7,762       8,087       8,755       9,704       11,429       10,133       12,831  

Pro forma net loss per share (unaudited):

               

Basic and diluted

            $ (0.18 )     $ (0.03 )

Shares used in pro forma per share calculations (unaudited)(2):

               

Basic and diluted

              29,935         32,058  

(footnotes on next page)

 

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(footnotes from prior page)

 

(1) Includes stock-based compensation expense as follows:

 

    

NovaCal

Pharmaceuticals,
LLC

   NovaBay Pharmaceuticals, Inc.
    

Period from
Jan 1,

2002 to

June 30,

2002

   Period from
July 1,
2002 to
December 31,
2002
                             
           Year Ended December 31,   

Three Months
Ended

March 31,

           2003    2004    2005    2006    2006    2007
                                               
     (unaudited)                             (unaudited)
     (in thousands, except per share data)

Stock-based compensation expense included above:

                       

Research and development

   $ —      $ 15    $ 2    $ 11    $ 55    $ 86    $ 15    $ 63

General and administrative

     —        —        —        —        16      281      21      175
                                                       

Total stock-based compensation expense

   $ —      $ 15    $ 2    $ 11    $ 71    $ 367    $ 36    $ 238
                                                       

 

(2) The pro forma weighted average common shares outstanding assumes the conversion of our convertible preferred stock into common stock as though the conversion had occurred on the first day of the fiscal year, or at the date of the original issuance, if later.

 

     NovaBay Pharmaceuticals, Inc.
    

December 31,

  

March 31,

2007

     2002     2003    2004    2005    2006   
                               (unaudited)
     (in thousands)

Balance Sheet Data:

                

Cash, cash equivalents and short-term investments

   $ 159     $ 1,104    $ 4,047    $ 3,212    $ 11,086    $ 10,053

Working capital

     (141 )     631      3,908      2,985      7,926      5,883

Total assets

     339       1,315      4,359      3,562      11,866      11,483

Capital lease obligation—current and non-current

     —         30      20      —        —        111

Deferred revenue—current and non-current

     —         —        —        —        9,167      9,217

Convertible notes payable

     235       405      —        —        —        —  

Convertible preferred stock

     27       65      164      175      192      192

Common stock and additional paid-in capital

     526       2,258      9,127      10,869      14,683      14,439

Total stockholders’ equity

     9       802      4,093      3,252      1,813      687

 

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF

FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of the financial condition and results of our operations should be read in conjunction with the financial statements and related notes included elsewhere in this prospectus. This discussion contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the section entitled “Risk Factors” included elsewhere in this prospectus.

Overview

We are a biopharmaceutical company focused on developing innovative product candidates targeting the treatment or prevention of a wide range of infections in hospital and non-hospital environments. Many of these infections have become increasingly difficult to treat because of the rapid increase in infectious agents that have become resistant to current drugs.

We have discovered and are developing a class of antimicrobial compounds, which we have named Aganocide compounds, that we believe could form a platform on which to create a variety of products to address differing needs in the treatment and prevention of bacterial infections. Our antimicrobial compounds are based upon small molecules that are generated by white blood cells that defend the body against invading pathogens. In the body, these compounds are produced “on demand” and are transient. We have focused our efforts on understanding these molecules and finding ways, primarily by chemical modification, to impart qualities to them to allow them to be developed as therapeutic products.

Our current development efforts are focused on Aganocide compounds to treat patients with infections of the eye, ear and sinus, to create an improved environment for the healing of wounds, whether chronic or acute, and to prevent infections that result from surgical or other hospital procedures, or that can be caused by the use of products, such as contact lens solutions, which can introduce an infection into the body. We operate in one business segment.

To date, we have generated no revenue from product sales, and we have financed our operations and internal growth primarily through the sale of our capital stock. We have also recently begun to generate revenue through payments for our research and development activities under our agreement with Alcon. We are a development stage company and have incurred significant losses since commencement of our operations in July 2002, as we have devoted substantially all of our resources to research and development. As of March 31, 2007, we had an accumulated deficit of $14.0 million. Our accumulated deficit resulted from research and development expenses and general and administrative expenses. We expect to continue to incur net losses over the next several years as we continue our clinical and research and development activities and as we apply for patents and regulatory approvals.

In August 2006, we entered into a collaboration and license agreement with Alcon to license to Alcon the exclusive right to develop, manufacture and commercialize products incorporating the Aganocide compounds for application in connection with the eye, ear and sinus and for use in contact lens solutions. Under the terms of the agreement, Alcon agreed to pay an up-front, non-refundable technology access fee of $10.0 million upon the effective date of the agreement. Additionally, we will receive semi-annual payments to support on-going research and development activities over the four year funding term of the agreement. The research and development support payments include amounts to fund a specified number of personnel engaged in collaboration activities and to reimburse us for qualified equipment, materials and contract study costs. Our obligation to perform research and development activities under the agreement expires at the end of the four year funding term. As product candidates are developed and proceed through clinical trials and approval, we will receive milestone payments. If the products are commercialized, we will also receive royalties on any sales of products containing

 

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the Aganocide compound. Alcon has the right to terminate the agreement in its entirety upon nine months’ notice, or terminate portions of the agreement upon 135 days’ notice, subject to certain provisions. Both parties have the right to terminate the agreement for breach upon 60 days’ notice.

There is a risk that any drug discovery and development program may not produce revenue. Moreover, because of uncertainties inherent in drug discovery and development, we may not be able to successfully develop and commercialize any of our product candidates. Any failure to complete the development of our product candidates in a timely manner would have a material adverse effect on our operations, financial position and liquidity. A discussion of the risks and uncertainties associated with completing our projects on schedule, or at all, and some consequences of failing to do so, are set forth in the “Risk Factors” section of this prospectus.

Financial Overview

Research and Development Expense

Since our inception, we have been focused on drug discovery and development programs. Research and development expense includes our costs for:

 

   

personnel associated with our research activities;

 

   

screening and identification of product candidates;

 

   

formulation and synthesis activities;

 

   

preclinical studies, including toxicology studies;

 

   

clinical trials; and

 

   

regulatory affairs.

We expense research and development costs as incurred. Costs incurred for general research and development activities were $1.3 million, $1.4 million and $2.5 million for the years ended December 31, 2004, 2005 and 2006, respectively, $1.5 million for the three months ended March 31, 2007 and $7.0 million for the period from inception to March 31, 2007. Research and development costs incurred to develop NVC-101 and our Aganocide compounds are summarized below.

 

     Year Ended December 31,    Three
Months
Ended
March 31,
2007
  

Inception to
Date

Development Project

   2004    2005    2006      

NVC-101

              

Toxicology/pharmacology

   $ 81,000    $ —      $ —      $ —      $ 93,000

Clinical trials

     75,000      473,000      857,000      53,000      1,458,000
                                  

Total expenses

   $ 156,000    $ 473,000    $ 857,000    $ 53,000    $ 1,551,000
                                  

Aganocide Compounds

              

Toxicology/pharmacology

   $ —      $ 52,000    $ 718,000    $ 104,000    $ 874,000

Clinical trials

     —        —        —        —        —  
                                  

Total expenses

   $ —      $ 52,000    $ 718,000    $ 104,000    $ 874,000
                                  

We expect that our research and development expenses will increase in future periods as we add personnel, fund studies and trials, and undertake regulatory filings. Additionally, we expect that our capital expenditures for laboratory equipment will increase in the future. Investments in laboratory equipment will increase our depreciation costs and will affect our liquidity by increasing cash used in investing activities. In March 2007, we filed an Investigational New Drug application, or IND, to initiate Phase I human clinical trials associated with

 

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our initial Aganocide compound, NVC-422. The FDA recently cleared our IND, and we began Phase I clinical studies in early May 2007.

Drug development in the United States is a process that includes several steps defined by the FDA. The FDA approval process for a new drug involves completion of preclinical studies and the submission of the results of these studies to the FDA, together with proposed clinical protocols, manufacturing information, analytical data and other information in an IND, which must become effective before human clinical trials may begin. Clinical development typically involves three phases of study: Phase I, II and III. The most significant costs associated with clinical development are the Phase III clinical trials as they tend to be the longest and largest studies conducted during the drug development process. After completion of clinical trials, a New Drug Application, or NDA, may be submitted to the FDA. In responding to an NDA, the FDA may refuse to file the application, or if accepted for filing, the FDA may grant marketing approval, request additional information or deny the application if it determines that the application does not provide an adequate basis for approval.

Some of our product candidates may be classified as medical devices rather than drugs. The procedure for obtaining FDA approval for medical devices is different than for drugs, but is likewise rigorous, lengthy and costly.

The successful development of our product candidates is highly uncertain. Satisfaction of all regulatory requirements applicable to our product candidates typically takes many years and requires the expenditure of substantial resources for research and development and testing. We cannot reasonably estimate or know the nature, timing and estimated costs of the efforts necessary to complete the development of, or the period in which material net cash inflows are expected to commence from, any of our product candidates due to the numerous risks and uncertainties associated with developing drugs.

Any clinical trials we conduct or that are conducted by our partners may not demonstrate the safety or efficacy of our product candidates. Success in pre-clinical testing and early clinical trials does not ensure that later clinical trials will be successful. Results of later clinical trials may not replicate the results of prior clinical trials and pre-clinical testing. Even if the results of one or more of our clinical trials are positive, we may have to commit substantial time and additional resources to conducting further preclinical studies or clinical trials before we can submit NDAs or obtain FDA approvals for our product candidates, and positive results of a clinical trial may not be replicated in subsequent trials.

Furthermore, if participating patients in clinical studies suffer drug-related adverse reactions during the course of such trials, or if we or the FDA believe that participating patients are being exposed to unacceptable health risks, we will have to suspend or terminate our clinical trials. Failure can occur at any stage of the trials, and we could encounter problems that cause us to abandon clinical trials or to repeat clinical studies.

In addition, the completion of clinical trials can be delayed by numerous factors, including delays in identifying and agreeing on acceptable terms with prospective clinical trial sites; slower than expected rates of patient recruitment and enrollment; increases in time required to complete monitoring of patients during or after participation in a trial; and unexpected need for additional patient-related data. The FDA may also require us to conduct additional clinical testing, in which case we would have to expend additional resources as well as time. The approval process may also be delayed by changes in government regulation, future legislation or administrative action or changes in FDA policy that occur prior to or during our regulatory review. Any of these delays, if significant, could impact the timing, approval and commercialization of our product candidates and could significantly increase our overall costs of drug development.

Even if our clinical trials are completed as planned, their results may not support our expectations or intended marketing claims. The clinical trials process may fail to demonstrate that our product candidates are safe and effective for indicated uses. Such failure would cause us to abandon a product candidate for some indications and could delay development of other product candidates. If we fail to obtain regulatory approval for

 

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any of our product candidates, we will not be able to commercialize our proposed products, and we will not generate product revenues.

General and Administrative Expense

Our general and administrative expenses consist primarily of salaries and other related costs for personnel serving executive, finance, legal, human resources, and information technology functions. Other costs include facility costs, professional fees for legal and accounting services, insurance, and depreciation expenses. We expect that, after this offering, we will incur significant additional accounting and legal costs related to compliance with securities and other regulations, as well as additional insurance, investor relations and other costs associated with being a public company.

Stock-Based Compensation Expense

Effective January 1, 2006, we began to measure and recognize compensation expense at fair value for all stock-based payments, in accordance with Statement of Financial Accounting Standard (“SFAS”) No. 123R, “Share-Based Payment”. Stock-based compensation expense is classified in the statements of operations in the same expense line items as cash compensation. We expect that amounts recognized in the future for stock-based compensation will be greater than stock-based compensation expense presented on a pro forma basis in the notes to our financial statements for the periods prior to the adoption of SFAS No. 123R, as we are no longer permitted to apply the minimum value method which assumed zero volatility. Instead, under SFAS No. 123R, we calculate the value of our stock-based payments using a volatility rate based upon the historical volatility of comparable companies from a representative peer group. Additionally, the stock-based compensation expense recognized in the statements of operations during 2006 does not include any expense for options granted but unvested at December 31, 2005. We expect stock-based compensation expense in 2007 and future periods to increase over the amounts recognized during 2006 as more options are granted subject to the SFAS No. 123R guidance. As of March 31, 2007, total unrecognized compensation cost related to unvested stock options granted or modified after January 1, 2006 was $562,000. This amount is expected to be recognized as stock-based compensation expense in our statements of operations over the remaining weighted-average vesting period of 1.9 years.

Other Income, net

Other income, net includes interest income on cash balances and interest expense on outstanding capital leases.

Provision for Income Taxes

Since inception, we have incurred operating losses and, accordingly, have not recorded a provision for income taxes for any of the periods presented. As of December 31, 2006, we had net operating loss and credit carryforwards for both federal and state income tax purposes of $6.4 million. We believe that sufficient uncertainty exists regarding the future realization of deferred tax assets. Accordingly, the net deferred tax assets have been fully offset by a valuation allowance. If not utilized, the federal and state net operating loss and credit carryforwards will begin expiring at various dates between 2015 and 2025. Under the Tax Reform Act of 1986, as amended, the amounts of and benefits from net operating loss and credit carryforwards may be impaired or limited in certain circumstances. Events that could cause limitations in the amount of net operating losses that we may utilize in any one year include, but are not limited to, a cumulative ownership change of more than 50%, as defined, that may occur, for example, as a result of this offering aggregated with certain other sales of our stock before or after this offering.

Critical Accounting Policies and Estimates

Our financial statements have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and

 

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liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements as well as the reported revenues and expenses during the reporting periods. In preparing these financial statements, management has made its best estimates and judgments of certain amounts included in the financial statements giving due consideration to materiality. On an ongoing basis, we evaluate our estimates and judgments related to revenue recognition, income taxes, intangible assets, long-term service contracts and other contingencies. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

While our significant accounting policies are more fully described in Note 2 to our financial statements, we believe that the following accounting policies are most critical to aid you in fully understanding and evaluating our reported financial results.

Revenue Recognition

License and collaboration revenue is primarily generated through an agreement with a strategic partner for the development and commercialization of our product candidates. We may enter into additional agreements with other strategic partners as opportunities arise. The terms of such agreements may include non-refundable upfront fees, funding of research and development activities, payments based upon achievement of certain milestones and royalties on net product sales. In accordance with Emerging Issues Task Force (“EITF”) Issue No. 00-21, “Revenue Arrangements with Multiple Deliverables”, we analyze our multiple element arrangements to determine whether the elements can be separated. We perform our analysis at the inception of the arrangement and as each product or service is delivered. If a product or service is not separable, the combined deliverables are accounted for as a single unit of accounting and recognized over the performance obligation period. We recognize revenue in accordance with SEC Staff Accounting Bulletin (“SAB”) No. 101, “Revenue Recognition in Financial Statements”, as amended by SAB No. 104 (together, “SAB 104”). In accordance with SAB 104, revenue is recognized when the following criteria have been met: persuasive evidence of an arrangement exists; delivery has occurred and risk of loss has passed; the seller’s price to the buyer is fixed or determinable and collectibility is reasonably assured.

Assuming the elements meet the EITF No. 00-21 criteria for separation and the SAB 104 requirements for recognition, the revenue recognition methodology prescribed for each unit of accounting is summarized below:

Upfront Fees —We defer recognition of non-refundable upfront fees if we have continuing performance obligations without which the technology licensed has no utility to the licensee. If we have continuing involvement through research and development services that are required because our know-how and expertise related to the technology is proprietary to us, or can only be performed by us, then such up-front fees are deferred and recognized over the period of continuing involvement.

Funded Research and Development —Revenue from research and development services is recognized during the period in which the services are performed and is based upon the number of full-time-equivalent personnel working on the specific project at the agreed-upon rate. Reimbursements from collaborative partners for agreed upon direct costs including direct materials and outsourced, or subcontracted, pre-clinical studies are classified as revenue in accordance with EITF Issue No. 99-19, “Reporting Revenue Gross as a Principal versus Net as an Agent,” and recognized in the period the reimbursable expenses are incurred. Payments received in advance are recorded as deferred revenue until the research and development services are performed or costs are incurred.

Milestones —Substantive milestone payments are considered to be performance bonuses that are recognized upon achievement of the milestone only if all of the following conditions are met: the milestone payments are non-refundable; achievement of the milestone involves a degree of risk and was not reasonably assured at the inception of the arrangement; substantive effort is involved in achieving the milestone; the amount of the

 

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milestone is reasonable in relation to the effort expended or the risk associated with achievement of the milestone; and a reasonable amount of time passes between the up-front license payment and the first milestone payment as well as between each subsequent milestone payment. If any of these conditions are not met, the milestone payments are deferred and recognized as revenue over the term of the arrangement as we complete our performance obligations.

Royalties —We recognize royalty revenues from licensed products upon the sale of the related products.

Research and Development Costs

We charge research and development costs to expense as incurred. These costs consist of direct and indirect costs associated with specific projects, as well as fees paid to entities that perform research and clinical trial studies on our behalf.

Patent Costs

We expense patent costs, including legal expenses, in the period in which they are incurred. Patent expenses are included as general and administrative expenses in our statements of operations.

Stock-Based Compensation

On January 1, 2006, we adopted the fair value recognition provisions of SFAS No. 123R, “Share-Based Payment”. SFAS No. 123R replaced SFAS No. 123 and superseded Accounting Principles Board (“APB”) Opinion No. 25 “Accounting for Stock Issued to Employees” and related interpretations. Under the fair value recognition provisions of SFAS No. 123R, stock-based compensation expense is measured at the grant date for all stock-based awards to employees and directors and is recognized as expense over the requisite service period, which is generally the vesting period. We were required to utilize the prospective application method prescribed by SFAS No. 123R, under which prior periods are not revised for comparative purposes. Under the prospective application transition method, non-public entities that previously used the minimum value method of SFAS No. 123 should continue to account for non-vested equity awards outstanding at the date of adoption of SFAS No. 123R in the same manner as they had been accounted for prior to adoption. SFAS No. 123R specifically prohibits pro forma disclosures for those awards valued using the minimum value method. The valuation and recognition provisions of SFAS No. 123R apply to new awards and to awards outstanding as of the adoption date that are subsequently modified.

Prior to the adoption of SFAS No. 123R, we accounted for stock-based compensation awards to employees using the intrinsic value method under the recognition and measurement principles of APB Opinion No. 25. Our application of APB Opinion No. 25 did not result in compensation expense because the exercise price of the stock-based awards was equal to the fair market value of the stock at the grant date.

We account for stock compensation arrangements with non-employees in accordance with SFAS No. 123R and EITF Issue No. 96-18, “Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services”, using a fair value approach. For stock options granted to non-employees, the fair value of the stock options is estimated using a Black-Scholes-Merton valuation model.

The adoption of SFAS No.123R had a material effect on our financial position and results of operations. See Note 8 to the financial statements for further information regarding stock-based compensation expense and the assumptions used in estimating that expense.

Income Taxes

We account for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying

 

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amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is recognized if it is more likely than not that some portion or all of the deferred tax asset will not be recognized.

Recently Issued Accounting Pronouncements

In July 2006, the Financial Accounting Standards Board (“FASB”) issued FASB Interpretation No. 48, “Accounting for Uncertainty in Income Taxes” (“FIN 48”). FIN 48 clarifies the accounting and reporting for uncertainties in income tax law. FIN 48 prescribes a comprehensive model for the financial statement recognition, measurement, presentation, and disclosure of uncertain tax positions taken or expected to be taken in income tax returns. FIN 48 is effective for fiscal years beginning after December 15, 2006. The adoption of FIN 48 did not have a material impact on our financial position or results of operations.

In September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements”. SFAS No. 157 establishes a framework for measuring the fair value of assets and liabilities. This framework is intended to provide increased consistency in how fair value determinations are made under various existing accounting standards which permit, or in some cases require, estimates of fair market value. SFAS No. 157 is effective for fiscal years beginning after November 15, 2007, and interim periods within those fiscal years. Earlier application is encouraged, provided that the reporting entity has not yet issued financial statements for that fiscal year, including any financial statements for an interim period within that fiscal year. We are currently assessing the impact of SFAS No. 157 on our financial position and results of operations.

In February 2007, the FASB issued SFAS No. 159 “The Fair Value Option for Financial Assets and Financial Liabilities”. SFAS No. 159 permits entities to choose to measure many financial assets and financial liabilities at fair value. Unrealized gains and losses on items for which the fair value option has been elected are reported in earnings. SFAS No. 159 is effective for fiscal years beginning after November 15, 2007. We are currently assessing the impact of SFAS No. 159 on our financial position and results of operations.

Results of Operations

Comparison of Three Months Ended March 31, 2006 and March 31, 2007

License and Collaboration Revenue

We recognized license and collaboration revenue of $1.5 million for the three months ended March 31, 2007. License and collaboration revenue consisted entirely of amounts earned under the license and collaboration agreement with Alcon. The revenue recognized for the period ended March 31, 2007 consisted of the current period amortization of the upfront technology access fee and amounts received, or expected to be received, for the funding of research and development activities performed during the period. As the Alcon agreement was effective in August 2006, no such revenue was recognized during the three months ended March 31, 2006.

The up-front technology access fee was initially recorded as deferred revenue and is expected to be amortized into revenue on a straight-line basis through August 2010. During the quarter ended March 31, 2007, we received a payment of $1.4 million to support the performance of research and development activities from January 2007 through June 2007. At March 31, 2007, our deferred revenue balance included $675,000 related to the unearned portion of this payment. This amount will be recognized as revenue during the second quarter of 2007 when the associated research and development activities are performed.

 

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Research and Development

Research and development expenses increased by 176% to $1.5 million for the three months ended March 31, 2007 from $0.5 million for the three months ended March 31, 2006. This increase was due in part to an increase in salary and benefits expense of $404,000, as the number of research and development personnel more than doubled from March 31, 2006 to March 31, 2007. Also, during the three months ended March 31, 2007, laboratory supplies and services expenses increased by $284,000, which was directly related to the increase in research and development personnel and the collaboration with Alcon, which resulted in a higher level of laboratory activities. Additionally, toxicology and pharmacology expenses increased by $92,000 from the first quarter of 2006 to the first quarter of 2007. This increase was primarily due to the initiation of studies for NVC-422 in the second half of 2006 and early 2007 in preparation for the IND filing. The increase in research and development expenses was also attributable to a $48,000 increase in regulatory expenses associated with the IND filing for NVC-422 during the first quarter of 2007. The amortization of stock-based compensation increased by $38,000 from the first quarter of 2006 to the first quarter of 2007 as a result of an increased number of grants becoming subject to the SFAS No. 123R guidance.

We expect that research and development expenses will continue to increase substantially during the remainder of 2007 and in subsequent years as we continue to increase our focus on developing product candidates, both independently and in collaboration with Alcon. In particular, we are expecting to incur significant clinical expenses during 2007 in connection with the Phase I clinical studies for NVC-422 which began in May 2007.

General and Administrative

General and administrative expenses increased by 44% to $1.0 million for the three months ended March 31, 2007 from $0.7 million for the three months ended March 31, 2006. This increase was due in part to an increase in salary and benefits expense of $118,000, as the number of general and administrative personnel more than doubled from March 31, 2006 to March 31, 2007. The increase in general and administrative expenses was also attributable to the issuance of $108,000 in cash and stock to a consultant for investor relations and financial advisory services during the first quarter of 2007. The amortization of stock-based compensation increased by $76,000 from the first quarter of 2006 to the first quarter of 2007 as a result of an increased number of grants becoming subject to the SFAS No. 123R guidance. Rent expense increased by $55,000 during the first quarter of 2007 because we leased additional space in late 2006 to accommodate our increased number of personnel and expanded laboratory facilities. The increase in general and administrative expenses was partially offset by a decrease of $85,000 related to one-time website and communication expenses that we incurred during the first quarter of 2006.

We expect that general and administrative expenses will increase during 2007 and in subsequent years due to increasing payroll, public company expenses, business development costs and expanding operational infrastructure. In particular, we expect to incur increasing legal, accounting, investor relations, equity administration and insurance costs in order to operate as a public company.

Other Income, Net

Other income, net increased to $122,000 for the three months ended March 31, 2007 from $30,000 for the three months ended March 31, 2006. This increase was attributable to increased interest income earned due to higher average cash balances resulting from the $10.0 million payment received in September 2006 and the $1.4 million payment received in January 2007 in connection with the Alcon agreement.

We expect that other income, net will vary based on fluctuations in our cash balances and the interest rate paid on such balances.

 

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Comparison of Years Ended December 31, 2005 and December 31, 2006

License and Collaboration Revenue

We recognized license and collaboration revenue of $1.5 million for the year ended December 31, 2006. License and collaboration revenue consisted of the current period amortization of the upfront technology access fee and amounts received for the funding of research and development activities performed during the year in connection with our collaboration and license agreement with Alcon.

Research and Development

Research and development expenses increased by 109% to $4.1 million for the year ended December 31, 2006 from $2.0 million for the year ended December 31, 2005. This increase was due in part to an increase in salary and benefits expense of $685,000, as the number of research and development personnel more than doubled from December 31, 2005 to December 31, 2006. The increase in research and development expenses was also attributable to a $665,000 increase in toxicology and pharmacology expenses related to the initiation of studies for NVC-422 during the year ended December 31, 2006. Additionally, an increase in expenses related to the NVC-101 clinical studies, which were concluded in late 2006, contributed $384,000 to the increase in research and development expenses. Also, during the year ended December 31, 2006, laboratory supplies and services expenses increased by $318,000, which was directly related to the increase in research and development personnel, which resulted in a higher level of laboratory activities. The increase in research and development expenses for the year ended December 31, 2006 also included amortization of stock-based compensation expense of $85,000 in connection with the adoption of SFAS No. 123R on January 1, 2006. No amounts were recognized for stock-based compensation during the year ended December 31, 2005.

General and Administrative

General and administrative expenses increased 84% to $3.0 million for the year ended December 31, 2006 from $1.6 million for the year ended December 31, 2005. This increase was due in part to an increase in salary and benefits expense of $410,000, as the number of general and administrative personnel doubled from December 31, 2005 to December 31, 2006. The increase in general and administrative expenses was also attributable to a $272,000 increase in expenditures for audit and legal services, in large part due to the completion of a multi-year audit in the first quarter of 2006 and the current year audit at the end of 2006. No audit fees were recorded during 2005. Also, increased patent activity pertaining to NVC-422 and its analogs contributed $130,000 to the increase in general and administrative expenses during the year ended December 31, 2006. This increase also included amortization of stock-based compensation expense of $227,000 in connection with the adoption of SFAS No. 123R on January 1, 2006. No amounts were recognized for stock-based compensation during the year ended December 31, 2005. We also incurred additional expenses of $73,000 during the year ended December 31, 2006 to develop our website and other communication capabilities. Rent expense increased by $47,000 during 2006 as we leased additional space to accommodate our increased number of personnel and expanded laboratory facilities.

Other Income, Net

Other income, net increased to $240,000 for the year ended December 31, 2006 from $106,000 for the year ended December 31, 2005. The increase was primarily due to increased interest income earned as a result of higher average cash balances due to the $10.0 million Alcon payment received in September 2006.

Comparison of Years Ended December 31, 2004 and December 31, 2005

Research and Development

Research and development expense increased 32% to $2.0 million for the year ended December 31, 2005 from $1.5 million for the year ended December 31, 2004. This increase was due in part to an increase in research

 

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and development salary and benefits expense of $400,000, as the staffing levels continued to grow from December 31, 2004 to December 31, 2005. Research and development expense also increased due to a $398,000 increase in clinical expenses related to the NVC-101 studies initiated during that time period. These increases during the year ended December 31, 2005 were partially offset by a $301,000 decrease in laboratory supplies and service expenses. In 2004 we increased our laboratory activity significantly in connection with the increase in the number of our research and development personnel. These expenses began to stabilize in 2005 as the number of our research and development personnel grew at a slower rate.

General and Administrative

General and administrative costs increased 20% to $1.6 million for the year ended December 31, 2005 from $1.3 million for the year ended December 31, 2004. This increase was partially due to an increase of $90,000 in expenditures related to accounting and information technology services as we expanded our finance and administrative departments. Also, increased patent activity pertaining to NVC-422 and its analogs contributed $131,000 to the increase in general and administrative expense during the year ended December 31, 2005. Additionally, rent expense for the year ended December 31, 2005 increased by $53,000 from December 31, 2004, reflecting the move to a new corporate headquarters during July 2004. As a result, rent expense for the year ended December 31, 2004 only reflected five months’ rent at the higher rate as compared to a full twelve months’ rent during the year ended December 31, 2005. These increases were partially offset by a decrease of $119,000 in investment banking fees. In 2004, we engaged an investment bank to explore potential financing options, none of which we ultimately pursued. No such fees were recognized during the year ended December 31, 2005.

Other Income, Net

Other income, net increased to $106,000 for the year ended December 31, 2005 from $22,000 for the year ended December 31, 2004. The increase was primarily due to increased interest income earned as a result of higher average cash balances and higher yields during the period.

Liquidity and Capital Resources

We have incurred cumulative net losses of $14.0 million since inception through March 31, 2007. We do not expect to generate significant revenue from product candidates for several years. Since inception, we have funded our operations primarily through the private placement of our preferred stock. We raised total net proceeds of $647,000 through the sale of our Series A Preferred Stock in 2002 and 2003, $3.0 million through the sale of our Series B Preferred Stock in 2003 and 2004, $5.4 million through the sale of our Series C Preferred Stock in 2004 and 2005, and $3.6 million through the sale of our Series D Preferred Stock in 2005 and 2006.

In August 2006, we entered into a collaboration and license agreement with Alcon. Under the terms of this agreement, we received an up-front technology access fee of $10.0 million in September 2006. Additionally, we are entitled to receive semi-annual payments each January and July over the next four years to support on-going research and development efforts. In 2006, we received a payment of $700,000 for the funding of research and development activities performed through December 31, 2006. During January 2007, we received a payment of $1.4 million to support the performance of research and development activities from January 2007 through June 2007. We expect to receive an additional payment of $1.4 million in July 2007 to support the research and development activities to be performed from July 2007 through December 2007.

The Alcon agreement also provides for milestone payments upon the achievement of specified milestones in each field of use and royalty payments upon the sale of commercialized products. The aggregate milestone payments payable in connection with the ophthalmic, otic and sinus fields are $19 million, $12 million and $39 million, respectively. We have not achieved any milestone nor has any product been commercialized to date. The achievement of the milestones and product commercialization is subject to many risks and uncertainties, including, but not limited to Alcon’s ability to obtain regulatory approval from the FDA and Alcon’s ability to

 

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execute its clinical initiatives. Therefore, we cannot predict when, if ever, the milestones specified in the Alcon agreement will be achieved or when we will receive royalties on sales of commercialized products.

During April 2007, we entered into a Master Security Agreement to establish a $1.0 million equipment loan facility with General Electric Capital Corporation. The purpose of the loan is to finance equipment purchases, principally in the build-out of our laboratory facilities. Borrowings under the loan will be secured by eligible equipment purchased from January 2006 through April 2008 and will be repaid over 40 months at an interest rate of 5.94% over the three year Treasury rate in effect at the time of funding.

On May 22, 2007, we borrowed $494,000 under the equipment loan facility. The principal and interest due under the loan will be repaid in equal monthly installments through September 2010 at an interest rate of 10.65%. As of the date of this prospectus, we had an outstanding loan balance of $479,000 under the facility.

Cash and Cash Equivalents

As of March 31, 2007, we had cash, cash equivalents, and short-term investments of $10.1 million compared to $11.1 million at December 31, 2006 and $3.2 million at December 31, 2005.

Cash Provided by (Used in) Operating Activities

For the three months ended March 31, 2007, cash used in operating activities of $320,000 was attributable primarily to our net loss of $893,000 and a $281,000 increase in prepaid expenses and other assets. Prepaid expenses and other assets increased due to an advance payment made to a vendor for our NVC-422 clinical study and due to the recognition of a receivable for amounts due from Alcon for reimbursable expenses. These amounts were offset by a $582,000 increase in accounts payable and accrued liabilities, primarily due to costs incurred in connection with the initial public offering that were accrued during the period but not paid until after March 31, 2007.

For the year ended December 31, 2006, cash provided by operating activities of $4.7 million was attributable primarily to an increase in deferred revenue related to the $10.0 million upfront technology access fee received from Alcon and an increase in accounts payable and accrued liabilities reflecting amounts that were expensed during the period but not paid until after December 31, 2006. This amount was offset by our net loss of $5.3 million, excluding the amounts recognized for stock-based compensation and depreciation, which are non-cash expenses.

For the year ended December 31, 2005, cash used in operating activities of $3.2 million was attributable primarily to our net loss of $3.5 million, excluding the amounts recognized for stock-based compensation and depreciation, which are non-cash expenses.

For the year ended December 31, 2004, cash used in operating activities of $2.5 million was attributable primarily to our net loss of $2.8 million, excluding the amounts recognized for losses on disposals of property and equipment and depreciation, which are non-cash expenses. This amount was partially offset by an increase of $193,000 in accounts payable and accrued liabilities, primarily due to research and development costs that were expensed during 2004 but were not paid until 2005.

Cash Provided by (Used in) Investing Activities

For the three months ended March 31, 2007, cash used in investing activities of $235,000 was attributable to purchases of property and equipment of $287,000 offset by net sales or maturities of short-term investments of $52,000. Net cash used in investing activities was $5.5 million for the year ended December 31, 2006 due to purchases of short-term investments (net of maturities) of $5.2 million and purchases of property and equipment

 

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of $362,000. Net cash used in investing activities was $1.1 million for the year ended December 31, 2005 due to the purchases of short-term investments (net of maturities) of $1.0 million and purchases of property and equipment of $123,000. For the year ended December 31, 2004, cash used in investing activities of $161,000 was attributable to purchases of property and equipment.

Cash Provided by (Used in) Financing Activities

Net cash used in financing activities of $487,000 was primarily attributable to costs incurred in connection with our initial public offering of $532,000 offset by $50,000 in proceeds from option exercises.

Net cash provided by financing activities of $3.5 million for the year ended December 31, 2006 was attributable to sales of preferred stock of $2.6 million and proceeds from option and warrant exercises of $1.0 million, partially offset by $93,000 of costs incurred in preparation for our initial public offering.

Net cash provided by financing activities for the years ended December 31, 2005 and 2004 was $2.5 million and $5.6 million, respectively. Net cash provided by financing activities in both years was primarily related to the sales of preferred stock.

We believe that the net proceeds from this offering, together with our cash balance at March 31, 2007 will be sufficient to fund our projected operating requirements through at least the next twelve months. However, we

will need to raise additional capital or incur indebtedness to continue to fund our operations in the future. Our future capital requirements will depend on many factors, including:

 

   

the scope, rate of progress and cost of our pre-clinical studies and clinical trials and other research and development activities;

 

   

future clinical trial results;

 

   

the terms and timing of any collaborative, licensing and other arrangements that we may establish;

 

   

the cost and timing of regulatory approvals;

 

   

the cost of establishing clinical and commercial supplies of our product candidates and any products that we may develop;

 

   

the effect of competing technological and market developments;

 

   

the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; and

 

   

the extent to which we acquire or invest in businesses, products and technologies, although we currently have no commitments or agreements relating to any of these types of transactions.

We do not anticipate that we will generate significant product revenue for a number of years. Until we can generate a sufficient amount of product revenue, if ever, we expect to finance future cash needs through public or private equity offerings, debt financings or corporate collaboration and licensing arrangements, as well as through interest income earned on cash balances and short-term investments. To the extent that we raise additional funds by issuing equity securities, our shareholders may experience dilution. In addition, debt financing, if available, may involve restrictive covenants. To the extent that we raise additional funds through collaboration and licensing arrangements, it may be necessary to relinquish some rights to our technologies or product candidates, or grant licenses on terms that are not favorable to us. If adequate funds are not available, we may be required to delay, reduce the scope of or eliminate one or more of our research or development programs or to obtain funds through collaborations for some of our technologies or product candidates that we would otherwise seek to develop on our own. Such collaborations may not be on favorable terms or they may require us to relinquish rights to our technologies or product candidates.

 

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Quarterly Results of Operations

The following table presents unaudited quarterly results of operations for the eight quarters ended March 31, 2007. This information has been derived from our unaudited financial statements and has been prepared by us on a basis consistent with our audited annual financial statements and includes all adjustments, consisting only of normal recurring adjustments, which management considers necessary for a fair presentation of the information for the periods presented.

 

    Three Months Ended  
    June 30,
2005
    Sept. 30,
2005
    Dec. 31,
2005
    Mar. 31,
2006
    June 30,
2006
    Sept. 30,
2006
    Dec. 31,
2006
    Mar. 31,
2007
 
   

(unaudited)

(in thousands, except per share data)

 

Statements of Operations Data:

               

Revenue

  $ —       $ —       $ —       $ —       $ —       $ 208     $ 1,325     $ 1,483  

Operating expenses:

               

Research and development

    543       523       350       531       788       1,122       1,646       1,463  

General and administrative

    399       390       460       717       714       634       907       1,035  
                                                               

Total operating expenses

    942       913       810       1,248       1,502       1,756       2,553       2,498  

Interest income and other, net

    47       17       28       30       9       58       143       122  
                                                               

Net loss before income taxes

    (895 )     (896 )     (782 )     (1,218 )     (1,493 )     (1,490 )     (1,085 )     (893 )

Provision for income taxes

    —         —         —         —         —         —         —         —    
                                                               

Net loss

  $ (895 )   $ (896 )   $ (782 )   $ (1,218 )   $ (1,493 )   $ (1,490 )   $ (1,085 )   $ (893 )
                                                               

Net loss per share:

               

Basic and diluted

  $ (0.09 )   $ (0.09 )   $ (0.08 )   $ (0.12 )   $ (0.14 )   $ (0.12 )   $ (0.09 )   $ (0.07 )

Shares used in per share calculations:

               

Basic and diluted

    9,622       10,025       10,072       10,133       10,517       12,469       12,561       12,831  

Pro forma net loss per share:

               

Basic and diluted

        $ (0.04 )   $ (0.05 )   $ (0.05 )   $ (0.03 )   $ (0.03 )

Shares used in pro forma per share calculations:

               

Basic and diluted

          27,684       28,740       31,466       31,788       32,058  

Stock-based compensation expense included above:

               

Research and development

  $ 10     $ —       $ —       $ 15     $ 23     $ 22     $ 26     $ 63  

General and administrative

    —         —         16       21       116       90       54       175  
                                                               

Total stock-based compensation expense

  $ 10     $ —       $ 16     $ 36     $ 139     $ 112     $ 80     $ 238  
                                                               

Our operating results have varied and will continue to vary in the future from quarter to quarter depending upon our level of business activities. Factors affecting our quarterly operating results include, but are not limited to:

 

   

changes in the level of our research and developments activities;

 

   

changes in the number of our personnel;

 

   

the acquisition or loss of partnering arrangements;

 

   

the achievement of milestones or other events requiring payments to us under partnering agreements;

 

   

the timing and success of development efforts for our product candidates;

 

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the amount and timing of expenditures to expand our operations; and

 

   

general economic, industry and market conditions.

Our operating results are difficult to forecast and will fluctuate, and we believe that quarter-to-quarter comparison of our operating results will not necessarily be meaningful. As a result, you should not rely upon them as an indication of our future performance.

Net Operating Losses and Tax Credit Carryforwards

As of December 31, 2006 we had net operating loss and credit carryforwards for both federal and state income tax purposes of $6.4 million. If not utilized, the federal and state net operating loss and credit carryforwards will begin expiring at various dates between 2015 and 2025. Under the Tax Reform Act of 1986, as amended, the amounts of and benefits from net operating loss and credit carryforwards may be impaired or limited in certain circumstances. Events that could cause limitations in the amount of net operating losses that we may utilize in any one year include, but are not limited to, a cumulative ownership change of more than 50%, as defined, that may occur, for example, as a result of this offering aggregated with certain other sales of our stock before or after this offering.

Contractual Obligations

At March 31, 2007, we did not have any amounts outstanding under debt or credit facilities.

Our contractual obligations as of March 31, 2007 were as follows:

 

Contractual Obligations:

   Payments Due by Period (in thousands)
   Total   

Less than

1 year

   1-3 Years    3-5 Years

Operating leases

   $ 1,857    $ 530    $ 936    $ 391

Capital lease

     130      44      86      —  

Our commitments under the operating leases shown above consist of payments relating to four leases for laboratory and office space in one office building in Emeryville, California. These leases have a range of expiration dates beginning on October 31, 2009 and ending on December 31, 2011.

Our commitment under the capital lease shown above consists of the total payments due under one lease of laboratory equipment. This amount includes $19,000 of interest payments over the 36 month term of the lease.

Inflation

We do not believe that inflation has had a material impact on our business and operating results during the periods presented, and we do not expect it to have a material impact in the near future. There can be no assurances, however, that our business will not be affected by inflation.

Off-Balance Sheet Arrangements

We have no off-balance sheet arrangements.

Quantitative and Qualitative Disclosures about Market Risk

Our concentration of credit risk consists principally of cash, cash equivalents, and short-term investments. Our exposure to market risk is limited primarily to interest income sensitivity, which is affected by changes in interest rates, particularly because the majority of our investments are in short-term debt securities.

 

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Our investment policy restricts our investments to high-quality investments and limits the amounts invested with any one issuer, industry, or geographic area. The goals of our investment policy are as follows: preservation of capital; assurance of liquidity needs; best available return on invested capital; and minimization of capital taxation. Some of the securities in which we invest may be subject to market risk. This means that a change in prevailing interest rates may cause the principal amount of the investment to fluctuate. For example, if we hold a security that was issued with an interest rate fixed at the then-prevailing rate and the prevailing interest rate later rises, the principal amount of our investment will probably decline. To minimize this risk, in accordance with our investment policy, we maintain our portfolio of cash equivalents, short-term marketable securities and restricted cash in a variety of securities, including money market mutual funds, Treasury bills, Treasury notes and commercial papers. The risk associated with fluctuating interest rates is limited to our investment portfolio. Due to the short term nature of our investment portfolio, we believe we have minimal interest rate risk arising from our investments. We do not use derivative financial instruments in our investment portfolio.

To date, we have operated exclusively in the United States. Accordingly, we do not have any material exposure to foreign currency rate fluctuations.

 

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BUSINESS

Overview

We are a biopharmaceutical company focused on developing innovative product candidates targeting the treatment or prevention of a wide range of infections in hospital and non-hospital environments. Many of these infections have become increasingly difficult to treat because of the rapid increase in infectious agents that have become resistant to current drugs.

We have discovered and are developing a class of antimicrobial compounds, which we have named Aganocide compounds, that we believe could form a platform on which to create a variety of products to address differing needs in the treatment and prevention of bacterial infections. Our current development efforts are focused on Aganocide compounds to treat patients with infections of the eye, ear and sinus, to create an improved environment for the healing of wounds, whether chronic or acute, and to prevent infections that result from surgical or other hospital procedures or that can be caused by the use of products, such as contact lens solutions, which can introduce an infection into the body.

Our antimicrobial compounds are based upon small molecules that are generated by white blood cells that defend the body against invading pathogens. In the body, these compounds are produced “on demand” and are transient. We have two primary compounds: NVC-101 and NVC-422. NVC-101, which we also refer to as NeutroPhase, is a solution containing hypochlorous acid, a small molecule that is the same as that which is naturally generated when a white blood cell defends the body against bacteria. NVC-422 is an analog of another molecule produced by a white blood cell and is now our lead compound, forming the basis of all of our Aganocide compounds. NVC-422’s primary advantage is that it kills a wide range of bacteria as well as certain yeasts, fungi and viruses, very rapidly, and we have demonstrated through in-vitro experiments that NVC-422 kills these pathogens at concentrations that are significantly lower than the concentrations at which it begins to harm human cells.

The development and commercialization of products based on our Aganocide compounds will require significantly more research, development and testing as well as governmental approvals. We intend to pursue the in-house development and commercialization of products designed to prevent selected nosocomial (hospital or institutional) infections and to partner with leading companies to assist us with the development of other products, where the expertise of the partner would help maximize the value of the particular product through development and/or commercialization.

In August 2006, we entered into a collaboration and licensing agreement with an affiliate of Alcon, Inc., a leading ophthalmic pharmaceutical company, to develop products incorporating Aganocide compounds for use in the eye, ear and sinus, as well as in contact lens solutions.

Industry Background

Combating bacterial infections is critical to modern medicine. Until the advent of antibiotics, led by the introduction of penicillin in the 1940s, infections were a routine cause of death. Since that time, antibiotics have greatly reduced the risks associated with bacterial infections, have made possible the routine use of surgical procedures for non-critical purposes and have increased the probability of success of many modern complex operations. As a result, most people in the developed world now tend to believe that bacterial infections can be readily treated with a course of antibiotic therapy; however, recent developments relating to bacterial resistance and bacterial biofilm are calling this into question.

Bacterial Resistance

Bacteria are becoming resistant to different classes of existing antibiotics at increasing rates. These increasing levels of resistance are principally the result of repeated exposure of bacteria to non-lethal quantities

 

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of antibiotics and the ability of certain bacteria to transmit mutant genes to other bacterial species, thus enabling different species of bacteria to survive the antibiotic to which the first species was exposed. The growth of this antibiotic resistance since 1990 has been substantial. The following graph illustrates the growth of resistance in intensive care unit infections in the United States from 1995 to 2004:

LOGO

Bacterial Biofilm

Many bacteria spend much of their existence within a matrix that they create, called biofilm. Biofilm consists of mucopolysaccharide (or slime-like) structures produced by microorganisms as a defense mechanism against their environment. Encased in biofilm, bacteria can survive for prolonged periods by assuming a dormant state. When bacteria are in a dormant state, they are largely immune to antibiotics, which are generally only effective against bacteria during specific non-dormant stages in their life cycle. When bacteria are protected by biofilm, antibiotics frequently provide only temporary relief and bacteria can eventually emerge from their biofilm to reinfect the patient. In biofilm, bacteria are also largely protected from white blood cells that normally kill most pathogens that enter the body. White blood cells combat bacteria by engulfing them, which they are unable to do once bacteria have created biofilm. Furthermore, many commonly used antiseptics are neutralized by biofilm.

According to the Center for Integrative Biology and Infectious Diseases of the National Institutes of Health (2007), biofilms account for 80% of the microbial infections in humans. Bacterial biofilm is associated with diseases such as sinus infections (sinusitis), ear infections, chronic wounds and infections related to cystic fibrosis. Bacterial biofilms are also frequently found on the surfaces of medical devices, such as catheters and implants, and can cause severe chronic or acute infections.

Market Opportunity

Limitations of Existing Anti-Infective Drugs . Many anti-infective drugs have limitations in their efficacy and application that may inhibit their effectiveness in treating many bacterial infections. These limitations include:

 

   

many current antibiotics are no longer effective in killing the growing number of resistant types of bacteria;

 

   

current antibiotics are generally ineffective in killing bacteria while they reside in biofilm; and

 

   

while most infections are localized, most current antibiotics used to treat bacterial infections are delivered systemically–either orally or through injection or infusion. As a result, the entire body is exposed to the antibiotic in order to treat a local infection in what may only be in, or on, a small part of the body. Furthermore, the dosage required to treat a local infection by systemic delivery is substantially higher than would be necessary to treat the local infection, resulting in greater risk of toxicity which can cause adverse side effects or other harmful effects on the human body.

 

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Hospital Infections . Increasing bacterial resistance, bacterial biofilm and the limitations of traditional antibiotic therapy are major contributors to the high cost of healthcare throughout the world. These problems are particularly evident in dealing with so-called “nosocomial” infections. These are infections that originate or occur in a hospital or hospital-like setting. According to the Pennsylvania Healthcare Cost Containment Council, in Pennsylvania hospitals alone, hospital-acquired infections led to approximately $2.9 billion of added costs in 2005 and, more significantly, almost 14% of those that acquired such infections died. Nosocomial infections result from a combination of four factors:

 

   

a high prevalence of disease-causing organisms,

 

   

a high prevalence of patients whose natural defenses (their immune system) are compromised because of illness or drugs,

 

   

a high prevalence of patients whose first line of defense against infection (their skin) has been breached due to injury, by surgery or through the use of catheters, and

 

   

a high risk of transmission of infection from one patient to another.

According to Emerging Infectious Diseases , a journal published by the Centers for Disease Control and Prevention (CDC) in 2001, each year there are 2,000,000 healthcare associated infections in the United States, which result in 90,000 deaths.

Our Solution

We have developed a class of antimicrobial compounds that we believe form a platform on which to create several products to address the differing needs in the treatment and prevention of bacterial infections. We believe that our Aganocide compounds can be highly effective in their antimicrobial activity, without causing harm to the body’s own cells, at doses that are likely to be used in therapy.

We believe the benefits of product candidates based upon our antimicrobial compounds will include:

 

   

Prevent or Treat Infections Caused by Resistant Bacteria . Our in-vitro and preliminary in-vivo animal tests indicate that our Aganocide compounds may be effective in destroying certain types of bacteria that have become resistant to existing antibiotics.

 

   

Destroy Bacteria Protected by Biofilm . We believe that effective treatment of several types of infections such as sinus infections, ear infections and bladder infections require products that can destroy bacteria even when resident in biofilm. In-vitro experiments indicate that our Aganocide compounds can be effective in destroying bacteria resident in biofilm. Although we have demonstrated that our Aganocide compounds can kill bacteria in biofilms grown in devices in laboratories, we need to show that our Aganocide compounds can kill bacteria in biofilm when those devices, such as catheters, are used in humans.

 

   

Allow for Treatment Without the Need to Identify the Causative Bacterium and its Susceptibility . We believe that our Aganocide compounds have the potential to be effective against most, if not all, species of bacteria, whether resistant or susceptible to current antibiotics. If we are able to prove this in human clinical trials, the use of an Aganocide product could eliminate the need to conduct diagnostic procedures to identify the bacteria causing the infection before commencing treatment.

 

   

Treat Certain Infections that May be Viral or Bacterial in Origin . Based on in-vitro and preliminary animal tests, we believe that our Aganocide compounds have the potential to kill not only bacteria, but also some viruses, thereby permitting immediate treatment for certain diseases where the causative agent may be a bacterium or a virus. These results will need to be confirmed in human studies.

 

   

Reduce Nosocomial (Hospital) Infections . We believe that Aganocide compounds may be able to contribute to preventing the occurrence and the transmission of hospital infections in several ways. For example, we have identified several applications for use of the Aganocide compounds in the prevention

 

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of infections that are associated with the use of invasive catheters, a major source of hospital infections. We need to develop appropriate formulations and methods of delivery in order to bring these product candidates to market.

 

   

Rapidly Killing Bacteria . Our tests indicate that our Aganocide compounds eliminate certain bacteria in minutes, whereas current therapies may take hours or days at analogous therapeutic concentrations. As a result, we believe that our product candidates could contribute to significant improvements in a variety of clinical procedures, including eliminating the need for days of clinical isolation currently necessary to allow some antibiotic therapies to run their course. To be successful in the marketplace, we need to demonstrate that our product candidates can be readily usable and do not disrupt the current practices of medical care.

 

   

Reduce Toxicity and Adverse Side Effects . Aganocide compounds are intended for localized application targeted at the specific area of infection and not for systemic use. Consequently, we believe that there may be a significant reduction in the risk of toxicity resulting in adverse side effects, as compared to the risks associated with systemic antibiotics. Although we have demonstrated that systemic absorption of our compounds is very low in animals, we need to confirm this in human studies.

 

   

High Therapeutic Index . The therapeutic index, as used to assess our compounds, is the ratio of the concentration at which a compound harms normal cells to the concentration at which it kills bacteria. Our in-vitro and in-vivo animal testing indicates that Aganocide compounds have a high therapeutic index, meaning that they can kill bacteria when delivered in concentrations far below the level that are likely to harm mammalian cells. We therefore expect products containing Aganocide compounds to enable more effective and safer treatment of diseases than other antimicrobial products, which may be effective in killing bacteria but which have greater risks of adverse side effects and other harmful effects on the body. We need to confirm these results in human clinical trials.

 

   

Resistance Unlikely . We believe that the development of resistance by bacteria to the Aganocide compounds is less likely than is the case with existing antibiotics because Aganocide compounds are analogs of the molecules used by the human immune system. The microbiocidal activity of NVC-101 and our Aganocide compounds is based on the use of active chlorine. Similar forms of active chlorine have been used to protect drinking water supplies throughout the world since the nineteenth century and no known resistance has been established.

 

   

Small Molecules Unlikely to Produce an Immune Reaction . The Aganocide compounds are small molecules. Unlike peptides and proteins, these molecules are of a size that is unlikely to generate an antibody response by the human body. Generally, only large molecules, infectious agents, or insoluble foreign matter will elicit an immune response in the body, however we need to conduct Phase I, II and III human clinical trials in order to confirm this.

We have demonstrated the benefits of our antimicrobial compounds in in-vitro and in-vivo animal studies; however, we will need to conduct Phase I, II and III human clinical trials to confirm such results in order to obtain FDA approval of our compounds. Often, positive in-vitro or in-vivo animal studies are not followed by positive results in human clinical trials, and we may not be able to demonstrate that our products are safe and effective for indicated uses in humans. However, historic data analyzed and published by CMR International, Limited indicates that anti-infective products that enter Phase I clinical trials have a higher probability of being subsequently approved for marketing than drugs in certain other categories. We believe this is the case because anti-infective drugs are designed not to act upon the human body and its cells, but to act upon microbes. For that same reason, we also believe that animal models of the treatment of infections are more predictive of the treatment of the same infections in humans than is the case in animal models of many other diseases of the human body. The bacteria used in in-vitro and in-vivo tests are the same as those found in human infections. We also believe that the microbiological end-points of clinical trials for anti-infective products are clearer (i.e., eradication or substantial reduction in the counts of the number of microbes) than is the case in many other disease categories. While our compounds are anti-infective, they kill bacteria by a different mechanism than the

 

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compounds that have been included in the CMR International report and, therefore, the historically higher probability of success of anti-infective products may not necessarily apply in the case of our Aganocide compounds.

Our Strategy

Our objective is to develop and commercialize NVC-101 and Aganocide-based products through both internal development efforts and partnerships with leading companies for certain applications. The key elements of our strategy include:

 

   

Developing Product Candidates In-house . We intend to develop our product candidates for selected indications for the prevention and treatment of nosocomial infections in-house and use qualified clinical research organizations to assist us with the clinical trials. The initial indications that we intend to develop are nasal decolonization (the treatment of nasal passages to eliminate harmful bacteria prior to surgery) and the prevention of infections associated with urinary tract catheters. However, we may reprioritize our efforts or abandon an indication based on results of our initial human trials.

 

   

Developing Products through to Proof-of-Concept for Multiple Indications . A major advantage of antimicrobial products is that success with laboratory and animal models tends to be much more predictive of eventual regulatory approval than is often the case with other classes of drugs. Reliable pre-clinical data often can be generated much faster and less expensively than having to achieve proof-of-concept (i.e., demonstration of safety and efficacy) through Phase II clinical trials. We believe this enables potential partners to evaluate our compounds much earlier than might otherwise be the case for drugs in other therapeutic categories.

 

   

Licensing Indications through Partnering Arrangements with Leading Companies . We intend to pursue partnering arrangements with leading companies in cases where we expect the likely magnitude, duration and expense of the clinical trial program required to obtain regulatory approval will be substantial and beyond our internal resources. In such cases, licensing the indications to leading companies in each field-of-use will enable us to take advantage of the partners’ resources and expertise in development, commercialization and sales and marketing of the resulting products. We may also pursue the formation of a joint venture where there are multiple opportunities in one therapy area.

 

   

Broadening the Range of Aganocide Compounds . We intend to continue to synthesize further Aganocide compounds. We are currently focusing our efforts on producing additional compounds for certain specific indications in collaboration with Alcon. We may continue to test new Aganocide compounds for other potential uses.

 

   

Provide Cost-Effective Solutions to the Problem of Hospital Infections. We expect to be able to provide products that will be cost-effective for hospitals to use to prevent and treat hospital infections that, according to Clinical Pulmonary Medicine (2002), cost between $5 and $10 billion per year in the United States, with much of that cost being a charge to the hospital. We expect that our product candidates, if successful, will enable savings to be made that would be significantly greater than the cost of the products, based upon our expectations of the cost of manufacture. In the complex hospital environment, we will need to clearly demonstrate the cost effectiveness of our products on the basis of well-designed pharmaco-economic trials.

Potential Company Milestones

Our current plans include the milestones indicated below. These milestones are, in whole or in part, outside our control and are subject to change. There are inherent risks and uncertainties in drug discovery and development, including those factors described in the “Risk Factors” section of this prospectus. The filing of an Investigational New Drug application (IND) requires substantial pre-clinical work in order to demonstrate to the FDA that the potential use of the drug in clinical trials for the intended indication is appropriate and likely to be safe. Clinical trials are frequently subject to delays or cancellation because of, among other things, problems with the drug, its formulation, the trial design and the enrollment of patients. This is especially true for Phase I and II

 

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clinical trials that are designed to explore the safety and preliminary efficacy of a product at different doses and often in different formulations. For example, we may learn from our Phase I clinical trials that we require a different formulation which may require us to repeat some animal studies before recommencing Phase I trials; this could postpone the target endpoint significantly. One of the primary goals of Phase II trials is to determine the design, dose and formulation of a drug to be taken into Phase III trials. Because of the high cost of Phase III trials, it may be necessary to repeat a Phase II trial to ensure that these factors have been sufficiently explored to be able to move prudently into a Phase III trial.

 

    

2007

 

2008

Nasal Decolonization

   File IND   Finish Phase II Trials
   Begin Phase I Trials   Begin Phase III Trials
   Complete Phase I Trials  
   Begin Phase II Trials  

Catheter Related Urinary Tract Infections

  

File IND

 

Begin Phase I Trials

     Complete Phase I Trials
     Begin Phase II Trials

Partnered Indications

   File IND   Begin Phase I
     Complete Phase I
     Begin Phase II
     File IND for second indication

New Partnering Agreements

   Enter into one agreement   Enter into one agreement

We expect the clinical development for each indication to take between three and five years to complete from the time of filing an IND, but such trials may take longer because of unforeseen issues that may require resolution before a trial can be completed.

Our Products and Technology

We have developed two primary compounds, NVC-101 (also referred to as NeutroPhase) and NVC-422, that we intend to use in the development of products to treat various bacterial infections. NVC-422 is our lead compound in a new class of antimicrobial compounds that we call the Aganocide compounds.

We developed our Aganocide compounds through research and development based on the human body’s natural immune system and the molecules involved in combating infections. The body’s primary defense against infection is the anatomic barrier of the skin and mucous membranes. Once pathogens penetrate the primary defense, the next line of defense is provided by the white blood cells. The most numerous of the white blood cells is the neutrophil. When it encounters bacteria or other pathogens, the neutrophil engulfs it and generates a series of small molecules with which to destroy it. The process in which these molecules are created is called the “oxidative burst”. These molecules typically have a very short life as they are created “on demand” to accomplish a specific task. We have focused our efforts on understanding these molecules and finding ways, primarily by chemical modification, to impart qualities to them to allow them to be developed as therapeutic products.

NVC-101 (NeutroPhase)

The primary molecule that is created in the oxidative burst is hypochlorous acid. Hypochlorous acid is highly reactive and kills bacteria in seconds. We have explored the properties of hypochlorous acid in a variety of animal models and have established the conditions under which it can be held stable. NVC-101 is our stable formulation of hypochlorous acid. NVC-101 can only exist in a solution. NVC-101 is extremely rapid acting and is very short-lived when applied to tissue. Because of these characteristics, we have decided to focus the development of NVC-101 on rapid cleansing and debridement in wounds, including surgical wounds, chronic wounds (e.g., “bed sores” and diabetic foot ulcers) and possibly burn wounds where there is a continued risk of surface infection.

 

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NVC-422

As the process of the oxidative burst continues, hypochlorous acid reacts with other molecules. Two molecules result from the reaction of hypochlorous acid with taurine: N-chlorotaurine (NCT) and N,N,-dichlorotaurine (NNDCT). Both NCT and NNDCT are antimicrobial, although NNDCT is significantly more so. However, both of these molecules are chemically unstable.

We have succeeded in creating stable analogs of these molecules, one of which is our NVC-422 compound. NVC-422 is our lead compound and it has a number of advantages. It kills a very wide range of pathogens, including not only bacteria, but also yeasts, fungi and some viruses. NVC-422 can kill pathogens very rapidly and can do so at concentrations significantly lower than the concentrations at which it begins to harm human cells.

Other Aganocide Compounds

In our research, we are also testing the antimicrobial and safety profiles in cell assays of additional compounds that have similar conceptual structures to NVC-422, but which may have different characteristics such as the ability to penetrate different tissues and the speed at which they kill pathogens. To date, we have created several other molecules that have similar antimicrobial properties to NVC-422. The additional Aganocide compounds that we are researching are shown in the following table (along with NVC-422), together with their therapeutic index, which is a measure of the relationship between safety and efficacy, based on our in-vitro tests. We measure safety by testing different concentrations of the compound against a standard mammalian cell type to find the concentration at which the compound kills 50% of the cells. We measure efficacy by testing different concentrations of the compound against standard bacterial strains to identify the level at which it kills more than 99.99% of those strains.

The therapeutic index of the following Aganocide compounds is the ratio of the concentration at which the compound harms mammalian cells to that at which it kills the specified bacteria in in-vitro tests. A high therapeutic index suggests better therapeutic activity.

 

     Escherichia coli    Psedomonas aeruginosa    Staph. aureus

NVC-422

   6,000    6,300    2,900

NVC-521

   2,000    1,000    500

NVC-524

   2,300    4,900    2,400

NVC-530

   4,600    5,100    1,200

NVC-539

   1,100    1,000    500

NVC-546

   2,100    4,400    2,100

NVC-570

   38    150    38

Data from experiments conducted by NovaBay

We are also currently exploring the other properties of these compounds (such as stability, ability to penetrate into tissue, duration of action, etc.). In our collaboration with Alcon, we are creating a significant number of additional compounds of this type to optimize their efficacy in the different target indications.

Although we have demonstrated the benefits of our antimicrobial compounds in in-vitro and in-vivo animal studies, we will need to conduct Phase I, II and III human clinical trials to confirm the safety and efficacy of the compounds. In addition, although we believe that in-vitro and in-vivo animal testing of the treatment of infections are far more predictive of the treatment of the same infections in humans than is the case for the treatment of other diseases of the human body, positive in-vitro results are often not followed by positive human tests results, and we cannot assure you that any human clinical trials we conduct will produce the same positive results that we obtained in our in-vitro and in-vivo animal studies.

 

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Characteristics of the NVC-101 and Aganocide Compounds

The NVC-101 and Aganocide compounds appear to share many highly desirable characteristics that have been demonstrated in in-vitro and in-vivo animal studies. These characteristics, however, will need to be confirmed in Phase I, II and III clinical trials before they can be approved by the FDA. Because the bacteria that we have used in our tests are the same as those found in human infections, the primary focus of our clinical trials will be to confirm that our formulations can effectively deliver the compounds to the site of the infection, without causing adverse side effects. It is possible however, that the positive results achieved in in-vitro or in-vivo animal studies will not be followed by positive results in human clinical trials.

Speed of Action

Unlike most antibiotics, which can take many hours to kill certain kinds of bacteria, NVC-101 and the Aganocide compounds, even at small doses, can kill bacteria in minutes. By increasing the concentration to doses that would be typically used in humans, we believe that the time to kill many types of bacteria should be a minute or less. The speed of action of a product may be important in many instances, because (a) a topical product may be rapidly removed from the area of application (e.g., by blinking in the case of ophthalmic formulations) or (b) it is infeasible to hold a product in place for a sustained period of time (e.g., in a flush solution to eliminate bacteria from biofilm in urinary tract catheters).

We submitted an Investigational New Drug Application (IND) for NVC-101 for use in infected chronic venous leg ulcer wounds, that was cleared by the FDA in 2004. The IND included the results of in-vitro and in-vivo animal tests that were either conducted in at least triplicate by NovaBay or were conducted by independent outside laboratories on our behalf and at our direction. These tests demonstrated that, at concentrations that are approximately 40 to 500-fold less than the intended concentration for use in humans, NVC-101 killed the following microbes in one minute or less:

 

Candida albicans 10231   Pseudomonas aeruginosa 27853
Corynebacterium amycolatum 49368   Serratia marcescens 14756
Enterobacter aerogenes 51697   Staphylococcus aureus 29213
Enterococcus faecium 51559 VRE   Staphylococcus aureus 33591, MRSA
Escherichia coli 25922   Staphylococcus epidermidis 12228
Haemophilus influenzae 49144   Staphylococcus haemolyticus 29970
Klebsiella pneumoniae 10031   Staphylococcus hominis 27844
Micrococcus luteus 7468   Staphylococcus saprophyticus 35552
Proteus mirabilis14153  
 
    The numbers shown in this table are the strain identification numbers of ATCC, an organization that provides standard biological materials to the industry and academia.

We believe that all these microbes are amongst those that may be found in a chronic wound, as well as in many other infectious conditions.

In our IND for NVC-422, we submitted data on its speed of action, including the time needed to kill the microbe with the minimum concentration at which the target organism is killed (MBC). This is a more demanding test than that undertaken with NVC-101 because in some cases the concentration used was as low as 0.003% of the expected concentration to be used in humans.

 

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LOGO

The graphs below further illustrate the rapidity of action of NVC-422 at higher concentrations.

LOGO

Broad Spectrum, Including Against Multi-drug Resistant Species

NVC-101 and our Aganocide compounds have killed, in-vitro, all bacteria and yeasts against which they have been tested. They were highly effective against two of the primary multi-drug resistant bacteria, Methicillin-Resistant Staphylococcus aureus (MRSA) and Vancomycin-Resistant Enterococcus (VRE). NVC-101 has been shown in in-vitro experiments to be highly effective against multiple strains of anthrax (Bacillus anthracis) , in both their vegetative and spore forms.

During a safety study in infected human wounds with NVC-101, conducted at a major woundcare center with the approval of its Institutional Review Board, there were indications of preliminary efficacy. By preliminary efficacy, we mean that there appears to have been a trend towards more rapid wound-healing when compared to subjects who received treatment with the control substance (saline). However, since this study was not designed to obtain FDA approval of a product as a drug, it should not be considered as being adequate for submission to the FDA as proof of efficacy. A full Phase I, II and III clinical program would be needed to obtain approval as a drug. The efficacy of NVC-101 was previously demonstrated in animal models of granulating wounds and diabetic wounds. By efficacy in animal models, we mean that animals treated with the test article had significantly lower levels of bacteria at the site of infection than those treated with a control product. Additionally, in the case of wound model studies, the test product was significantly better than the control product in increasing the speed of healing as measured by the rate of closure of the wound.

 

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In-vivo, NVC-422 has demonstrated efficacy in infected animal models of chronic wounds, eye infections and ear infections. The following tables show the activity of NVC-422 against multi-drug resistant strains of bacteria recovered from recent nosocomial infections in animal tests. They indicate the MIC (Minimum Inhibitory Concentration) required for different antibiotics against which they were tested. They compare the concentration of the antibiotic or NVC-422 required to kill a standard strain against the concentration to kill the resistant strain.

LOGO

 

LOGO

 

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Before we can claim that our product candidates are effective against multi-drug resistant bacteria in human infections, we will have to demonstrate such efficacy in Phase I, II and III clinical trials and receive the approval of the FDA or other relevant regulatory authorities.

High Therapeutic Index

All therapeutic drugs will be toxic at some dose or concentration, resulting in adverse side effects or other harmful effects on the body. In order to assess the relative risk that may be associated with our compounds, we calculate a therapeutic index, which is the ratio of the concentration at which sensitive mammalian cells are killed compared to that at which specific bacteria are killed. A higher ratio is better, because a drug with a high therapeutic index can kill bacteria at concentrations far below those that are likely to harm human cells. Drugs with a low therapeutic index, where the difference between the level at which they are effective and the level at which they harm humans is very small, are difficult to use and require significantly more patient monitoring. Below is a chart comparing the relative safety (as measured by CT 50 —the concentration at which 50% of a standard mammalian cell line is killed) and efficacy (as measured by MBC—the concentration required to kill 99.9% of bacteria in the test) of existing topical anti-bacterial products based upon data generated in experiments conducted in our own laboratories. The levels of safety and efficacy have been standardized by giving Silver Nitrate an Index Value of 1.

LOGO

The chart below shows how NVC-101 and NVC-422 compare to the products in the previous graph.

LOGO

 

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Thus, NVC-101 demonstrates, in these in-vitro studies, greater efficacy than existing anti-bacterial products and NVC-422 has significantly less cell toxicity, which should allow its use in higher concentrations. We believe that this high therapeutic index will permit our product candidates to be used in conditions, such as in chronic wounds or other sensitive tissues, where existing antiseptics should generally not be used.

In addition to in-vitro tests against mammalian cells conducted in-house, we contracted with outside parties to conduct animal toxicity studies on our behalf and at our direction. For NVC-101, these included ocular (eye) toxicity, skin sensitization and toxicity studies on two species of animals with full-thickness wounds. For NVC-422, NovaBay and Alcon have either conducted or contracted for toxicity studies in the eye, ear and nose, as well as systemic studies using intravenous injection. NVC-422 has also been used in pharmacological studies in the bladder. Based on these studies, we believe there should be safe therapeutic doses for NVC-101 and NVC-422 that are several times greater than those required to kill target pathogens.

Efficacy Against Bacterial Biofilm

In data developed at an independent laboratory on our behalf and at our direction, NVC-422 was demonstrated to be highly effective against well established biofilm grown on urinary tract catheters.

Effect of two concentrations of NVC-422 on bacteria in biofilm

LOGO

To try to reduce the amount of bacteria and biofilm in urinary tract catheters, saline (salt with water) is typically used to flush the catheter. The chart above shows that compared with this traditional method, NVC-422 is dramatically better in this in-vitro model at killing the bacteria embedded in biofilm on the catheter.

Resistance Not Expected

We do not expect that our compounds will allow bacteria to generate resistance to their action. A pharmacophore is the essential feature responsible for a drug’s biological activity. In our compounds, the pharmacophore is the chlorine ion. This is the same pharmacaphore produced by the neutrophil (white blood cell) during what is known as the oxidative burst.

We believe that bacteria have not been able to find a way to survive when under direct attack by the chlorine ion. Furthermore, the developed world’s water supply has been protected for over a century through the use of various chemicals incorporating the chlorine ion and no known resistance to the chlorine ion has emerged despite this widespread use.

 

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Aganocide Compounds Are Not Systemic

Aganocide compounds are intended for localized application targeted at the specific area of infection and not for systemic use. In contrast, most antibiotics need to reach the site of infection through the bloodstream, after direct infusion or after absorption of an oral tablet or capsule. This means that the antibiotic is being distributed throughout the whole body, whether required or not. There are a few conditions, such as bloodstream infections where that is necessary; however, the vast majority of infections are located at a specific site in or on the body, and the use of systemic drugs in these instances only serves to increase the risk of side-effects. In addition, the use of antibiotics throughout the body to target one specific species of bacteria can enable other species to develop resistance to that antibiotic.

Aganocide Compounds Are Analogs of a Natural Molecule

NVC-422 is a synthetic analog of a molecule, N-Chlorotaurine, that is produced by white blood cells as part of the innate immune system’s defense against invading pathogens. However, unlike NVC-422, N-Chlorotaurine is unstable and undergoes a process of dehydrohalogenation, a process whereby active chlorine atoms form inactive hydrogen chloride, which means that it cannot be packaged and sold as a finished product ready for use. We have demonstrated the stability of NVC-422 over two years in a pharmaceutical formulation.

Our Target Markets and Their Development Status

We believe that the characteristics of our product candidates make them suitable for multiple target markets. The following table summarizes the primary target indications for our current and anticipated development efforts for applications we presently intend to develop with partners and those we intend to develop in-house:

 

Target Indications

 

Status

Partnering Indications:

 

Conjunctivitis (pink eye)

  Licensed to Alcon

Sinus Infections

  Licensed to Alcon

Ear Infections

  Licensed to Alcon

Contact Lens Solutions

  Licensed to Alcon

Woundcare Indications

 

Proof of Concept complete;

no partner arrangement currently

Skin Infections (Dermatology)

  No partner arrangement currently

Cystic Fibrosis

 

Initial Test of Concept in progress;

no partner arrangement currently

In-House Development:

 

Pre-Surgery Nasal Decolonization

  IND submission completed Q1 2007

Catheter Associated Urinary Tract Infections

  Human Trials expected 2008

Dialysis Access Associated Infections

  Human Trials expected 2008

Central Venous Catheter Infections (Prophylaxis)

  Proof of Concept trials expected 2008

Ventilator Associated Pneumonia

  Test of Concept expected 2008

In the above table, we refer to “Test of Concept” or “Proof of Concept”. “Test of Concept” refers to animal or human studies that we are performing, or intend to perform, in order to confirm that there are grounds for believing that the relevant compound may be effective in a particular indication. “Proof of Concept” indicates that the test of concept work has been completed to a point at which we believe that we can present the data to potential outside partners or can make the judgment to embark on development of the indication in-house.

We plan to devote a portion of our future efforts to developing certain indications to a level at which we will have established proof of concept in appropriate animal models (or, if necessary, in humans). Once this has been

 

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completed, we should then be in a position to decide whether to partner with another company for the development of the indication, continue the development ourselves or terminate it as a potential indication. We may add further indications as we increase our understanding of the properties of the Aganocide compounds.

Conjunctivitis

Conjunctivitis is the inflammation or infection of the membrane lining the eyelids, commonly known as pink eye. The most frequent cause is a viral (principally adenovirus) infection that is typically very contagious. However, conjunctivitis may also be caused by bacterial infection, among other causes. The specific cause of conjunctivitis, whether viral or bacterial, often cannot be determined without laboratory tests that are normally not conducted. According to the CDC, conjunctivitis was responsible for more than 5,000,000 visits to physicians during 2002.

Despite the availability of a number of different therapies, in many respects the treatment of conjunctivitis is an unmet medical need, as evidenced by the following:

 

   

There is currently no product available that addresses viral conjunctivitis.

 

   

Primary care physicians are rarely able to distinguish between viral and bacterial conjunctivitis, and microbiological investigations are generally not undertaken in primary care to aid in diagnosis.

 

   

The standard of care is to prescribe antibiotics for conjunctivitis, even though the majority of cases will not respond because they are viral in origin.

 

   

Conjunctivitis has a significant impact on school and workplace productivity because of the contagious nature of the disease.

Potential Value of Our Approach

 

   

Tests conducted by outside investigators indicate that an Aganocide product candidate may be the first product to address both viruses and bacteria, the two major causes of the disease.

 

   

Replacing antibiotics with an Aganocide product in this indication could contribute to a reduction in the growth of bacterial resistance to antibiotics, because much of the use of antibiotics in this indication is inappropriate.

 

   

According to a report in the Wall Street Journal in February 2007, the U.S. market for ophthalmic antibiotics is approximately $600 million. Most of these products are being prescribed for conjunctivitis.

Status of Our Program

 

   

In-vivo safety of NVC-422 in the animal eye has been demonstrated.

 

   

In-vitro tests have been completed against viruses involved in conjunctivitis.

 

   

Additional pre-clinical and clinical development is being conducted by Alcon.

Sinus Infections (Sinusitis)

Sinusitis, the infection of the sinuses, is a prevalent disease. According to the CDC, 14% of adults have been diagnosed with sinusitis and approximately 31 million people in the United States suffer each year from this condition. According to the Sinus and Allergy Partnership, in one-third of the cases, the infection continues to recur. While the disease is usually bacterial in origin, it also may be viral or fungal. According to studies conducted at the University of West Virginia, published in Laryngoscope in 2005, biofilm was found in more than 80% of patient samples where there was a recurrent disease. According to the American Academy of Family

 

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Physicians , sinusitis is the third largest market for antibiotics, although studies have shown that antibiotics are largely ineffective at preventing recurrence of this condition.

We believe that this is a significant area of unmet medical need because:

 

   

The number of patients with a recurrent form of the disease is substantial.

 

   

According to the New England Journal of Medicine (1996), $5 billion was spent in the United States on conventional healthcare costs associated with treating patients with sinusitis.

 

   

We believe the current efforts to treat sinusitis are a significant contributor to bacterial resistance because of the inappropriate use of antibiotics.

Potential Value of Our Approach

We have tested an Aganocide compound in an animal model of chronic sinusitis. If the results are replicated in human patients in Phase I, II and III clinical trials and the product is approved by the FDA, it may offer a more effective treatment for sinusitis than existing antibiotics because:

 

   

The Aganocide compounds appear to have action against viruses and fungi, in addition to bacteria. Consequently, it may be possible for a single Aganocide product to be used to attack three potential sources of infection in a condition where microbiological diagnosis is difficult.

 

   

Based on our studies, Aganocide compounds also appear to be effective against those bacteria that have embedded themselves in biofilm, which may also prevent acute infections from progressing to chronic infections.

 

   

We expect the use of an Aganocide compound to reduce the growth of antibiotic resistance because it could reduce the inappropriate use of systemic antibiotics.

 

   

Antibiotics generally only provide temporary symptomatic relief against chronic sinusitis, because the microbes resident in biofilm (the underlying cause of chronic sinusitis) tend to survive the antibiotic treatment and later emerge from the biofilm to restart the infection and the subsequent inflammatory response that causes pain.

Status of Our Program

 

   

We have conducted preliminary tests on cats suffering from sinusitis with positive efficacy results.

 

   

A full pre-clinical and clinical program may be conducted by Alcon.

Ear Infections

Ear infections fall into one of two categories: (i) Otitis Externa, an inflammation of the outer ear, and (ii) Otitis Media, an infection of the middle ear.

Otitis Externa is an inflammation of the external ear canal that causes pain and may lead to hearing loss. It can become chronic. According to eMedicine (May 2005), approximately 1.2 million people in the United States suffer from Otitis Externa every year, and the CDC estimates that approximately 5.3 million doctor visits per year in the United States are the result of Otitis Externa (2001-2002 data).

We believe that a need exists for more effective treatment of Otitis Externa because:

 

   

This disease can be caused by bacterial and fungal infections and current products do not address both causes.

 

   

According to the American Family Physician , 36% of patients in the United States had to cease work for a median period of four days as a result of Otitis Externa and 21% of those patients required bed-rest because of the pain.

 

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Potential Value of Our Approach

 

   

Our in-vitro studies suggest that our Aganocide compounds are effective against all the causative agents of Otitis Externa, including fungi.

 

   

If we can replicate the in-vitro results that we have obtained against bacteria in biofilm in human clinical trials and obtain FDA approval, an Aganocide product could be used to prevent the recurrent form of Otitis Externa by eliminating bacteria resident in biofilm and fungi.

Status of Our Program

 

   

We have conducted preliminary studies in dogs with Otitis Externa with indications of efficacy.

 

   

This program is now being conducted by Alcon.

Otitis Media is an infection of the middle ear, which is particularly prevalent in young children. We believe that an Aganocide product, if approved by the FDA after Phase I, II and III clinical trials, might play a potentially important role in treating this disease. A recently published study in the Journal of the American Medical Association has indicated that this disease is associated with biofilm. As a consequence, the CDC is urging more limited use of antibiotics to treat this disease.

Potential Value of Our Approach

 

   

Current antibiotics are ineffective against this painful condition.

 

   

90% of pre-school children experience at least one incidence of Otitis Media.

 

   

30-40% of children have recurrent attacks.

 

   

The Aganocide compounds may prevent the recurrent form of Otitis Media by eliminating bacteria resident in biofilm and fungi.

Status of Our Program

 

   

The Otitis Media indication has been licensed to Alcon.

Contact Lens Solutions

We believe there is increasing consumer concern regarding the adequacy of contact lens solutions to provide adequate disinfection of certain microorganisms. We have partnered with Alcon to develop Aganocide compounds for use in disinfecting solutions to offer contact lens users better protection from microorganisms than existing alternatives provide. According to the Wall Street Journal , more than 30 million people in the U.S. use contact lenses that require disinfecting solutions.

Potential Value of Our Approach

We believe that Aganocide compounds have the potential to protect contact lens users from microorganisms better than existing alternatives because:

 

   

Aganocide compounds have a broad spectrum of activity against bacteria, yeasts and fungi.

 

   

Aganocide compounds may have the ability to destroy organisms that can form biofilm on contact lenses and in the storage cases in which they are kept.

 

   

Infections that result from the failure of contact lens solutions to provide adequate disinfection can be devastating. The Journal of the American Medical Association reported in August 2006 that one-third of individuals infected as a result of a disinfection failure require corneal transplants.

 

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Status of Our Program

 

   

We are actively engaged in identifying suitable molecules in our collaboration with Alcon.

 

   

Alcon intends to conduct formulation development and testing.

Woundcare Indications

According to the Agency for Healthcare Research and Quality, five to seven million people in the United States suffer each year from chronic wounds, such as diabetic foot ulcers, venous ulcers and pressure ulcers (bed sores). We believe that there are many more who suffer from wounds in accidents and as a consequence of surgery. According to the Agency for Healthcare Research and Quality, in 2004, burns were noted as a diagnosis in 52,400 hospital stays in the United States.

We believe that this is a significant area of unmet medical need because:

 

   

Open wounds are particularly susceptible to infection.

 

   

U.S. Public Health Service Guidelines strongly recommend against the use of existing topical disinfectants because they interfere with wound healing.

 

   

Chronic wounds are associated with aging, and we expect the number of patients with chronic wounds to increase as a result of a growing aging population in the developed world.

 

   

The number of patients with diabetes who will develop diabetic foot ulcers is expected to grow. According to the New England Journal of Medicine (January 2007), 312 million people in the world are now considered obese and that, consequently, diabetes is rapidly emerging as a global healthcare problem that threatens to reach pandemic levels. According to eMedicine (updated 2004), 15% of persons with diabetes develop foot ulcers.

Potential Value of Our Approach

   

There is a need for products that can be used safely to reduce and control the growth of bacteria in chronic wounds.

 

   

Our compounds appear to be safe in animal studies of wounds and, in the case of NVC-101, in preliminary human studies on patients with chronic wounds.

 

   

Studies, that we supported financially, were conducted by the Institute of Tissue Regeneration, Repair and Rehabilitation, Florida on a wounded rat model. Such studies suggest that:

 

   

NVC-422 is effective in reducing infection to levels that are compatible with wound healing.

 

   

NVC-422 has a positive impact on the rate at which wounds heal.

 

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LOGO

Time taken for animal wounds to heal when treated with saline and two concentrations of NVC-422

Status of Our Program

 

   

We have conducted animal studies for safety and efficacy in this area, which showed the safety and efficacy of NVC-101 and NVC-422 in animal models.

 

   

We have conducted animal toxicology studies of NVC-101 in wounds and have submitted the data to the FDA.

 

   

We have conducted human safety studies of a formulation of NVC-101 under the approval of the Institutional Review Board at San Francisco Wound Center, with no adverse events attributed to the drug by the investigator.

 

   

We have conducted limited exploratory studies of NVC-101 under an Investigational New Drug application (IND) for use in infected chronic venous leg ulcer wounds with no adverse events attributable by the investigators to the product candidate.

 

   

We have submitted a 510(k) premarketing application with the FDA to clear NVC-101 as a wound cleansing solution with antimicrobial attributes under the medical device regulations.

 

   

We are exploring partnership opportunities with leading companies in the woundcare market.

Dermatology

In The Burden of Skin Diseases (2005), The Lewin Group reported that, in 2003, the cost of prescription drugs used in dermatological indications, in which we believe our product candidates would have applicability, was $3.9 billion. According to Postgraduate Medicine (1997), some specialists in Europe and New Zealand have called for a moratorium on the use of topical antibiotics to prevent the spread of resistance. This is echoed by the increasing call by public authorities such as the CDC and state consumer education organizations for more restrictive use of antibiotics.

Potential Value of Our Approach

The concern regarding resistance to dermatological antibiotics is causing regulatory authorities to pressure doctors to reduce the number of prescriptions of antibiotics in “mild” indications. This has had a significant impact on the sale of dermatological antibiotics, especially in Europe. We believe that our Aganocide compounds may be able to treat many dermatological conditions without contributing to increased bacterial resistance. We believe that the in-vivo work conducted in animals to date indicates that our Aganocide compounds are safe for use in dermatological conditions, because it has been shown to be non-irritating in more sensitive tissues.

 

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Status of Our Program

 

   

We are conducting preliminary formulation experiments to create a suitable cream, ointment or gel.

 

   

We are exploring partnership opportunities in this market.

Cystic Fibrosis

Cystic fibrosis is a genetic disorder that causes a build-up of bacterial biofilm in the lungs of those affected. The early death of persons with cystic fibrosis is usually due to infections caused by Pseudomonas bacteria associated with biofilm. The primary antibiotic used to treat this condition is TOBI ® -tobramycin. According to Chiron Corporation, sales of TOBI ® were $233 million in 2005. Studies indicate that resistance to tobramycin is becoming a significant problem. Acta Physiologica reported in 2006 that 26 of 29 cystic fibrosis patients in a study developed pseudomonas infections with resistance to inhaled tobramycin and that higher levels of resistance were correlated to significantly greater loss of lung function.

Potential Value of Our Approach

 

   

Our in-vitro studies indicate that Aganocide compounds are effective against bacteria in biofilm and, for that reason, we believe that, if a suitable formulation and delivery means can be developed and its safety and efficacy can be demonstrated in Phase I, II and III clinical trials to the satisfaction of the FDA, NVC-422 may be effective against pseudomonas in biofilm in Cystic Fibrosis.

 

   

We do not expect that Aganocide compounds, which we believe will be delivered locally by inhalation, will give rise to the problems associated with systemic toxicity relating to current treatments. Our studies in animals indicate that Aganocide compounds are minimally absorbed, if at all.

 

   

Unlike current treatments, we do not expect, based on our understanding of the mechanisms of bacterial resistance, that NVC-422 would generate resistance from pseudomonas bacteria.

Status of our Program

 

   

We have begun external in-vitro studies and in-vivo studies in animals to see if the Aganocide compounds can play a role in this indication.

 

   

We have begun working with external investigators to conduct in-vitro work with sputum from patients with cystic fibrosis.

 

   

We are beginning in-vivo studies in a cystic fibrosis animal model.

Pre-Surgery Nasal Decolonization

Pre-surgery nasal decolonization involves the treatment of the nasal passages to eliminate potentially harmful bacteria, especially Staph. aureus, prior to surgery in order to reduce the number of surgical site infections. According to the Pennsylvania Health Care Cost Containment Agency, over 1.2% of hospital patients acquired a nosocomial infection in Pennsylvania in 2005. Of those patients that acquired a nosocomial infection 13% died. Of those that did not acquire a nosocomial infection, only 2.3% died. That study indicated that the average additional cost of treating a patient that contracted an infection may have been over $150,000 per patient.

According to the Guideline for Prevention of Surgical Site Infection, published by the CDC in 1999, approximately 500,000 patients in the United States suffer from infections contracted during surgery. There are approximately 27,000,000 surgical procedures conducted each year in the United States according to this

 

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Guideline. Studies conducted in Germany and reported in January 2001 in the New England Journal of Medicine indicate that of 219 patients that developed bloodstream Staph. aureus infections following surgery, the causative agent in 180 of them was the genetically identical strain of Staph. aureus to that which each had in their own nasal passages.

Any form of infection with Staph. aureus results in a prolonged hospital stay, but that stay is even longer when the infection is caused by the resistant strain Methicillin Resistant Staph. aureus or MRSA. According to a study in Emerging Infectious Diseases (2004), hospital costs were approximately $120,000 for those with MRSA surgical site infections, $75,000 for those with a non-resistant Staph. aureus infection in their surgical site and $35,000 for those that did not have a surgical site infection.

We believe that this is a significant area of unmet medical need because:

 

   

The current means of nasal decolonization is very difficult to integrate into current hospital practice as it involves screening for the Staph. aureus bacteria, isolating patients who are carriers of that bacteria and treating them for approximately five days with nasal mupirocin (Bactroban ® ) antibiotic.

 

   

Resistance to mupirocin, an antibiotic commonly used in nasal decolonization, is rising significantly and therefore treatment of this disease with mupirocin may no longer be tenable in the near future. In a retrospective study at the Mayo Clinic published in the Journal of Clinical Microbiology in August 2005, 27% of those patients with MRSA prosthetic joint infections after surgery were mupirocin resistant.

 

   

Several European countries have accepted nasal decolonization of patients as a common pre-surgical practice for non-emergency surgery.

Potential Value of Our Approach

AgaNase, our formulation of the Aganocide compound, NVC-422, as a nasal spray or swab, is being developed for nasal decolonization of Staph. aureus.

We believe, based on our in-vitro studies, that NVC-422 is effective against both resistant and non-resistant strains of Staph. aureus.

 

   

NVC-422 is highly effective against Staph. aureus, killing that bacteria in under a minute in our tests at doses significantly below the anticipated level at which it will be administered in humans.

 

   

We believe that it may be possible to adequately decolonize the nasal passages before any surgery using nasal sprays of AgaNase administered over a one hour period.

Status of Our Program

 

   

We have completed all pre-clinical studies and submitted an IND for this indication to the FDA in March 2007. The IND was cleared in April 2007.

 

   

We have contracted for the conduct of Phase I clinical trials that began in May 2007.

 

   

We are preparing for the conduct of Phase II clinical trials that we expect to start in Europe in late 2007 or early 2008.

Catheter Associated Urinary Tract Infections

Kalorama International forecasts that the number of urinary tract catheters that will be used worldwide in 2007 is expected to be 207 million. According to the CDC (Emerging Infectious Diseases, 2001) more than 5 million patients use urinary tract catheters in U.S. acute-care hospitals and extended care facilities. The risk of

 

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infections with short-term usage of urinary tract catheters is 5% per day according to the CDC. More than 40% of all nosocomial infections occur as a result of the use of urinary tract catheters. According to the CDC, catheter associated urinary tract infections comprise one of the largest institutional reservoirs of nosocomial antibiotic-resistant pathogens. In experiments conducted at the Center for Biofilm Engineering, Montana State University during 2005 and 2006, it was demonstrated in-vitro that NVC-422 can destroy the bacteria resident in biofilm on urinary tract catheters.

Potential Value of Our Approach

With bacterial biofilm being a major cause of catheter associated urinary tract infection, we expect that the use of an Aganocide solution could have a significant benefit in preventing these infections.

Status of our Program

 

   

We have conducted preliminary pharmacology studies in the human bladder with no signs of toxicity at doses significantly above the anticipated level at which the compound will be administered to humans.

 

   

Studies at the Center for Biofilm Engineering demonstrated that, in an in-vitro model of urinary tract catheters and artificial urine, a 99.9999% reduction in bacteria resident in biofilm per square centimeter of urinary catheter could be achieved using NVC-422.

 

   

We are planning the formal toxicity studies needed to proceed to human trials with the intent of filing an IND for this indication in the fourth quarter of 2007.

 

   

We expect to begin human trials in 2008.

Dialysis Access Associated Infections

According to an article in Nephrology, Dialysis, Transplantation (June 2005), 22% of dialysis patients in the United States were hospitalized because of infections related to implanted access lines and 58% of dialysis patients hospitalized for infection had a “severe” outcome (defined as death, a stay in intensive care unit or prolonged hospitalization). It has been demonstrated through an analysis of several published studies that effective nasal decolonization significantly reduces the rate of infection. In addition, we will be examining the use of a “lock solution” to protect the dialysis access line from the growth of bacterial biofilm.

Potential Value of Our Approach

We expect that the use of either an access lock solution or nasal decolonization containing NVC-422 could contribute to a reduction in the infection rates among the dialysis population. A combination of both approaches might have added benefit.

Status of our Program

We are currently planning the toxicity studies that will be required to support the use of an access lock solution.

Central Venous Catheter (CVC) Infections (Prophylaxis)

The use of catheters to deliver medications and to readily obtain access to the circulatory system has become the norm in modern hospital care. Unfortunately, they penetrate the primary defense against infection–the skin–and serve as a conduit for bacteria to invade the human body. According to Infections in Medicine, 2004, approximately 5 million CVCs are used in the United States each year. Although intravascular catheters are indispensable in contemporary medical practice, their increased use over the past 20 years has been

 

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associated with at least a doubling of resultant CVC-associated blood-stream infections. Each year in the United States, approximately 80,000 CVC-associated bloodstream infections occur in patients in intensive care units and up to 250,000 occur throughout the health care system. These infections are associated with significant morbidity and prolongation of hospital stay. In intensive care units patients, the attributable cost of care is estimated to be from $34,508 to $56,000 per episode. These bloodstream infections are serious and are frequently caused by resistant bacteria.

Potential Value of Our Approach

We are developing a formulation of NVC-422 as a catheter lock solution. A catheter lock solution is injected into the catheter after each delivery of medicine or withdrawal of a blood sample in order to keep the catheter open and filled with solution. Currently, heparin solutions are frequently used for this purpose.

 

   

Heparin solutions, while effective at keeping the catheter line open, facilitate the growth of bacteria because heparin is a nutritional product for bacteria. Our tests indicate that the use of an Aganocide solution will eliminate this problem by killing the bacteria.

 

   

Bacteria typically form biofilm on the interior surface of the catheter and are very difficult to clear. Frequent replacement of the catheters is expensive and difficult as it requires the use of X-rays to ensure that the catheter is correctly placed. We have demonstrated, in-vitro, that NVC-422 can significantly reduce the number of bacteria present in biofilm on catheters.

Status of Our Program

We have established in 28 day peripheral intravenous animal toxicity studies the concentration of NVC-422 at which there are no adverse effects in the animal model. We will use that concentration as a guide to appropriate dosing in humans. Before proceeding to file an IND to permit human studies, we will need to conduct further pharmacology and toxicology studies in order to establish the concentration of NVC-422 that is expected to be without toxicity when delivered close to the entrance to the heart.

Ventilator Associated Pneumonia

Patients who require the assistance of a mechanical ventilator to support their breathing are at a high risk of infection. Biofilm can form in their ventilator breathing tube and can then become an on-going source of infection. Ventilator associated pneumonia accounted for 27% of all infections in hospital intensive care units according to the Guidelines for Preventing Health-Care-Associated Pneumonia, issued by the CDC in 2003.

Potential Value of Our Approach

Because of the biofilm-related nature of the cause of the infection, we believe that a solution containing an Aganocide compound has the potential to prevent the formation of biofilm and eliminate the reservoir of infection in ventilator tubes.

Status of our Program

This currently is a conceptual program. We have no data at this time to support safe usage in the lungs, although we expect to be able to evaluate lung toxicity as a result of our cystic fibrosis studies.

Alcon Collaboration Agreement

In June 2005, we initiated our collaboration with Alcon and its affiliates and agreed to supply compounds and products exclusively to them for use in the eye, ear and sinus. Alcon and its affiliates undertook to evaluate our compounds for use in the eye, ear and sinus and to provide us with reports on their findings. In August 2006,

 

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we entered into a License and Collaboration Agreement with Alcon pursuant to which we have licensed to Alcon the exclusive rights (except for certain retained marketing rights) to develop, manufacture and commercialize products incorporating the Aganocide compounds for application in connection with the eye (including contact lens solutions), ear and paranasal sinus (excluding the nares).

Pursuant to the Alcon agreement, we received payment from Alcon of a non-refundable technology access fee of $10.0 million in September 2006. In addition to the technology access fee, we are entitled to payments from Alcon on a semi-annual basis in connection with the research and development conducted by us under the Alcon agreement for four years after the effective date of the agreement, unless Alcon elects to extend this funding term. The amount of such payments will depend upon the number of persons dedicated by NovaBay to supporting the research program agreed with Alcon. In addition, if certain milestones are achieved in connection with the development of a product, we are entitled to receive certain milestone payments for the first achievement of each such milestone for a licensed product in each field of use (eye, ear or sinus), which vary in amount depending on the field of use and on the type of milestone event achieved. These milestone events relate to the stage of development of the applicable product. The aggregate milestone payments payable in connection with the ophthalmic, otic and sinus fields are $19 million, $12 million and $39 million, respectively. Finally, if products developed under the Alcon agreement are commercialized, we will be entitled to receive royalty payments, which vary by field of use and whether the product is covered by a valid claim of one of our patents. Alcon is responsible for all the costs that it occurs in developing the products using the Aganocide compounds. We have not achieved any milestones nor has any product been commercialized to date. The achievement of the milestones and product commercialization is subject to many risks and uncertainties, including, but not limited to Alcon’s ability to obtain regulatory approval from the FDA and Alcon’s ability to execute its clinical initiatives. Therefore, we cannot predict when, if ever, the milestones specified in the Alcon agreement will be achieved or when we will receive royalties on sales of commercialized product.

We have retained the rights to market, via a co-marketing partner, any products developed for ear or sinus indications in the major Asian markets, including Japan, China, India and South Korea. We have also retained such rights in other markets if Alcon is not committing reasonably sufficient sales and marketing resources to the particular product. In each instance, the appointment of the co-marketing partner would be subject to certain conditions, including that the co-marketing partner be approved by Alcon. The co-marketing partner, or NovaBay on its behalf, would be required to pay Alcon a royalty based on net sales of the product in the applicable market and would also be required to reimburse Alcon for part of its local development costs or, in the case of underserved markets, all of its local development costs. These products may also be marketed in those markets by Alcon, its affiliates or distributors.

Alcon has the right to terminate the Alcon agreement in whole on nine months’ prior notice to us or on 135 days notice with respect to specific fields of use where the Coordination Committee (a committee formed under the Alcon agreement and consisting of members from Alcon and NovaBay) determines that it is unlikely that any product will obtain regulatory market approval or be a commercial success in any major market in such field of use.

Research and Development

As of March 31, 2007, we had 24 employees dedicated to research and development. Our research and development expenses consist primarily of personnel-related expenses, laboratory supplies and services provided within our research, development and clinical groups. We expense our research and development expenses as they are incurred. Research and development expenses for 2004, 2005, 2006 and the first quarter of 2007 were $1.5 million, $2.0 million, $4.1 million and $1.5 million, respectively. All of our research and development employees are engaged in drug research and development activities, including those related to the Alcon agreement described above. We expect to incur significant research and development expenses for the foreseeable future.

 

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Intellectual Property

We rely on a combination of patent, trademark, copyright and trade secret laws in the United States and other jurisdictions, as well as confidentiality procedures and contractual provisions, to protect our proprietary technology. We also enter into confidentiality and invention assignment agreements with our employees and consultants and confidentiality agreements with other third parties, and we rigorously control access to our proprietary technology.

We have filed trademark applications for NovaBay and Aganocide in the United States, the European Union, and Japan, and for AgaNase and NeutroPhase in the United States.

We have one issued patent and five pending provisional and non-provisional applications in the United States. We also have five pending international applications filed under the Patent Cooperation Treaty, and one issued patent in Mexico, one issued patent in China, and 36 pending foreign national applications in Europe, Argentina, Australia, Brazil, Canada, China, Hong-Kong, Israel, India, Japan, South Korea, Mexico, Singapore, New Zealand and Taiwan.

The issued U.S. patent provides coverage for a method of treating burns or promoting wound healing, tissue repair or tissue regeneration using a specific range of formulations of NVC-101. This patent was issued in July 30, 2002 and will expire in 2020. The subject matter of our patents and patent applications cover the following three key areas: methods relating to the manufacture and use of NVC-101, composition of matter of the Aganocide compounds and their compositions, and methods of treatment utilizing the Aganocide compounds.

The U.S. patent application covering the Aganocide compounds will, if granted, expire in 2024, with additional compounds covered by further patent applications that, if granted, would expire in 2025.

Competition

The market for drugs and medical devices designed to treat or prevent bacterial infections is highly competitive. If developed, our products would compete against a wide variety of existing products, products and technologies that are currently in development, and products and technologies that could be developed and reach the market before or after any products that we develop may be introduced. In particular, we would be competing against existing antibiotics that are sold by many major pharmaceutical companies, or generic equivalents that are being distributed, typically at low prices.

Our potential competitors include large and small pharmaceuticals and medical device companies, such as Pfizer, Inc., Johnson & Johnson, Abbot Grp. Plc., GlaxoSmithKline Plc, Sanofi-Aventis SA, Smith & Nephew Plc, and Novartis AG. Some of these competitors may have far greater resources and experience in the area than we do and may develop and patent processes or products earlier than we are able to, develop and commercialize products that are less expensive or more efficient than any products that we may develop, obtain regulatory approvals for competing products more rapidly than we are able to, and improve upon existing technological approaches or develop new or different approaches that render any technology or products we develop obsolete or uncompetitive.

These healthcare companies may develop and commercialize competitive products such as:

 

   

improved antibiotics that better treat infections and address the shortcomings of current treatments;

 

   

biofilm-related products including: products that inhibit the creation of biofilm, such as drugs and catheter-lock solutions; products that destroy biofilm (as opposed to the bacteria within the biofilm); products that are applied to medical devices to inhibit biofilm formation; and products that remove biofilm from medical devices;

 

   

products based on new compounds with attributes similar to Aganocide compounds;

 

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improved antiseptic products with applications similar to certain uses of products that we intend to develop;

 

   

products for wound cleansing and debridement (the removal of tissue that is dead or infected) and similar products; and

 

   

antimicrobial catheters and dressings that contain silver or other antimicrobial compounds.

According to Commercial Insights: Antibacterials (December 2006) published by Datamonitor, there were five new unlaunched antibiotics in Phase III studies or awaiting approval by the FDA. All of these antibiotics are being targeted at hospital acquired infections, especially MRSA. However, they are all products that would be delivered by injection after an infection has been identified. One company is also attempting to extend the use of photodynamic therapy, which is used primarily for periodontal disease, into nasal decolonization of Methacillin Resistant Staph. aureus . The technology requires that the area to be decontaminated should be soaked with a solution and then the solution has to be activated by the use of a laser device, and does not appear to have been readily accepted for use for indications different than its current use. Other companies are believed to be developing compounds that disrupt biofilms or the formation of biofilm. We are aware that one company has announced that it expects to begin Phase I trials in 2010 for the use of a derivative of an existing drug against bacteria in biofilm.

NeutroPhase, if launched for use in wound management, will be competing against multiple products with similar indications for use. However, we believe there is currently no dominant product in this indication.

We believe the principal competitive factors for products in our target markets include their effectiveness in killing bacteria, including bacteria in biofilm, time to kill bacteria, safety, side effects and cost effectiveness. We believe that our compounds may, if approved by the regulatory authorities, have significant advantages over existing compounds and compounds in development of which we are aware, because our Aganocide and NVC- 101 compounds could be used to prevent infections or to treat infections where speed of action, action against bacteria in biofilm, action in topical indications or action against multi-drug resistant bacteria is important.

However, we cannot assure you that our competitors will not succeed in developing technologies and products that are more effective than any developed by us or that would render our technologies and any products we develop obsolete. If we are unable to compete successfully against current or future competitors, we may be unable to obtain market acceptance for any product candidates that we create, which could prevent us from generating revenues or achieving profitability.

Manufacturing and Supply

We do not currently operate manufacturing facilities for clinical or commercial production, as we rely on and leverage the manufacturing and distribution infrastructure of third parties. We have no plans to establish our own manufacturing facilities in the future. Third party vendors supply us with the Active Pharmaceutical Ingredient (API) of NVC-422 and the finished clinical trials materials for NVC-101, which are manufactured in compliance with the FDA’s “Current Good Manufacturing Practice”, or CGMP, regulations. We also intend to work with third parties for future clinical trial materials and commercial supplies of NVC-422.

The Alcon Agreement provides for the manufacture by Alcon of finished dosage forms of products incorporating Aganocide compounds for sale under our label in those markets where we have retained marketing rights.

Sales and Marketing

Our lead product candidate, NVC-422, as well as many of the product candidates we expect to develop in the future, are intended to address a variety of different market segments, some of which are large, primary care markets. We do not currently have, nor do we intend in the near term to create, a commercialization organization

 

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capable of marketing, selling and distributing our targeted product candidates to large, primary care markets. This applies to markets in both the United States and elsewhere. Rather, we intend to establish commercialization partnerships with pharmaceutical, biotechnology or other leading organizations with the experience and resources to bring our products to market. In some cases, we may enter into agreements with these organizations during the development stage of a product candidate to further benefit from their clinical development, regulatory, market research, pre-marketing and other expertise, as is the case with Alcon. As appropriate, we may establish a specialty sales force with expertise in marketing and selling any future approved products to specialty physicians for specific target indications. We may also establish other complementary capabilities related to marketing and selling targeted medicines, particularly where those capabilities may not currently exist at other organizations.

Government Regulation

The testing, manufacturing, labeling, advertising, promotion, distribution, export and marketing of our product candidates are subject to extensive regulation by the FDA and comparable regulatory authorities in state and local jurisdictions in the U.S. and in other countries. Because our programs involve product candidates that are considered as medical devices and others that are drugs, we intend to submit applications to regulatory agencies for approval or clearance of both medical devices and pharmaceutical product candidates.

U.S. Government Regulation

In the United States, the FDA regulates drugs and medical devices under the Federal Food, Drug, and Cosmetic Act and the agency’s implementing regulations. If we fail to comply with the applicable United States requirements at any time during the product development process, clinical testing, and the approval process or after approval, we may become subject to administrative or judicial sanctions. These sanctions could include the FDA’s refusal to approve pending applications, license suspension or revocation, withdrawal of an approval, warning letters, adverse publicity, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties or criminal prosecution. Any agency enforcement action could have a material adverse effect on us.

Our products may be classified by the FDA as a drug or a medical device depending upon the indications for use or claims. We believe the use of NVC-101 as a solution for cleansing and debriding wounds would be considered as a medical device. Similarly, NVC-422 may be classified as a medical device depending on the indication for use. For example, we believe if the indication is for bladder lavage, it would be classified as a medical device, whereas we believe it would be considered a drug when it is indicated for the prevention of urinary tract infection. In addition, the determination as to whether a particular indication is considered a drug or a device is based in part upon prior precedent.

Drug Approval Process

The process required by the FDA before a drug may be marketed in the United States generally involves satisfactorily completing each of the following:

 

   

preclinical laboratory tests, animal studies and formulation studies all performed in accordance with the FDA’s Good Laboratory Practice, or GLP, regulations;

 

   

submission to the FDA of an IND application for human clinical testing, which must become effective before human clinical trials may begin;

 

   

performance of adequate and well-controlled clinical trials to establish the safety and efficacy of the product candidate for each proposed indication;

 

   

submission to the FDA of a New Drug Application, or NDA;

 

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satisfactory completion of an FDA inspection of the manufacturing facility or facilities, including those of third-parties, at which the product is produced to assess compliance with strictly enforced current GMP regulations; and

 

   

FDA review and approval of the NDA before any commercial marketing, sale or shipment of the product.

Preclinical Studies and IND Application

Preclinical tests include laboratory evaluations of product chemistry, formulation and stability, as well as studies to evaluate toxicity in animal studies. The results of the preclinical tests, together with manufacturing information and analytical data, are submitted to the FDA as part of an IND application. The IND becomes effective 30 days after receipt by the FDA, unless the FDA, raises concerns or questions about the conduct of the proposed clinical trial, including concerns that human research subjects will be exposed to unreasonable health risks. In that case, the IND sponsor and the FDA must resolve any outstanding FDA concerns before the clinical trials can begin. Submission of an IND may result in the FDA not allowing the trials to commence or not allowing the trial to commence on the terms originally specified in the IND.

Clinical Trials

Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators. Clinical trials are conducted under protocols detailing, among other things, the objectives of the study, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. Each protocol must be submitted to the FDA as part of the IND. An independent Institutional Review Board, or IRB must also review and approve the clinical trial before it can begin and the IRB must monitor the study until it is completed. The FDA, the IRB or the sponsor may suspend or discontinue a clinical trial at any time for various reasons, including a finding that the subjects are being exposed to an unacceptable health risk. Clinical testing also must satisfy extensive good clinical practice requirements and the requirements for informed consent.

Clinical trials typically are conducted in three sequential phases, but the phases may overlap or be combined. Additional studies may be required after approval.

 

   

Phase I studies are initially conducted with relatively few subjects to test the drug candidate for safety, dosage tolerance, absorption, metabolism, distribution and excretion and, if possible, to gain an early indication of its effectiveness. Such studies are conducted in healthy humans, or, on occasion, in patients.

 

   

Phase II studies are generally controlled clinical trials conducted with a relatively small number of subjects to:

 

   

evaluate dosage tolerance and appropriate dosage;

 

   

identify possible adverse effects and safety risks; and

 

   

evaluate, preliminarily, the efficacy of the drug for specific indications in patients with the disease or condition under study.

 

   

Phase III studies, commonly referred to as pivotal studies are undertaken with large numbers of patients (several hundred to several thousand) to further evaluate dosage, to provide substantial evidence of clinical efficacy and to further test for safety in an expanded and diverse patient population at multiple, geographically dispersed clinical trial sites.

 

   

Phase IV post-approval studies, to further assess the drug’s safety and effectiveness, are sometimes required by the FDA as a condition of approval.

 

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Our clinical trials may not proceed in this order for each indication. In addition our Phase I, Phase II and Phase III testing may not be completed successfully within any specified period, if at all.

New Drug Application

The results of our preclinical testing and clinical trials, together with other detailed information, including extensive manufacturing information and information on the composition of the product, will be submitted to the FDA in the form of an NDA requesting approval to market the product for one or more specified indications. The FDA reviews an NDA to determine, among other things, whether a product is safe and effective for its intended use.

If the NDA submission is accepted for filing, by law the FDA has 180 days to review the application and respond to the applicant. The review process is often significantly extended by FDA requests for additional information or clarification. The FDA may refer the NDA to an advisory committee for review, evaluation and recommendation as to whether the application should be approved. The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations. The FDA may deny approval of an NDA or it may require additional clinical data, including additional Phase III clinical trial or trials. Even if such data is submitted, the FDA may ultimately decide that the NDA does not satisfy the criteria for approval. Data from clinical trials is not always conclusive and the FDA may interpret data differently than we interpret data. Even after the FDA initially approves an NDA, the FDA may withdraw the approval if ongoing regulatory requirements are not met or if safety problems are identified after the drug reaches the market. In addition, the FDA may require testing, including Phase IV clinical trials, risk minimization action plans, and surveillance programs to monitor the effect of approved products, which have been commercialized. The FDA has the authority to prevent or limit further marketing of a drug based on the results of these post-marketing programs.

Certain changes to an approved application, including changes in indications, labeling, or manufacturing processes or facilities, require submission and FDA approval of a new NDA or NDA supplement. An NDA supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing NDA supplements as it does in reviewing NDAs.

Before approving an application, the FDA will inspect the facility or the facilities, including third-party facilities where the drug is manufactured, for compliance with current good manufacturing practice, or CGMPs. The FDA may also inspect the clinical sites at which the trials were conducted to assess their compliance with good clinical practice requirements. If the FDA concludes that the application demonstrates that the product is safe and effective for the proposed indication, and that the manufacturing process and the manufacturing facilities meet CGMPs, the FDA will issue an approval letter. If the FDA concludes that the application, manufacturing process or manufacturing facilities are not acceptable, the FDA will outline the deficiencies in the submission and often will request additional testing or information. Notwithstanding the submission of any requested additional information, the FDA ultimately may decide to not approve the application.

Post Approval

If regulatory approval of a product or new indication for an existing product is obtained, we will be required to comply with a number of post-approval requirements. We will be required to report certain adverse reactions and production problems to the FDA, provide updated safety and efficacy information and to comply with requirements concerning advertising and promotional labeling requirements. Drug manufacturers and certain of their subcontractors are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with ongoing regulatory requirements, including CGMP regulations, which impose certain procedural and documentation requirements upon drug manufacturers. Accordingly, we and our third-party manufacturers must continue to expend time, money, and effort in the areas of production and quality control to maintain compliance with CGMP regulations and other regulatory requirements.

 

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Medical Devices

We expect some of our products to be regulated as medical devices. Unless an exception applies, each medical device we wish to commercialize in the United States will require either prior 510(k) clearance or premarket approval from the FDA. The FDA classifies medical devices into one of three classes. Devices deemed to pose lower risks are placed in either Class I or II, which requires the manufacturer to submit to the FDA a premarket notification requesting permission to commercially distribute the device. This process is generally known as 510(k) clearance. Some low risk devices are exempt from this requirement. Devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices, or devices deemed not substantially equivalent to a previously cleared 510(k) device, are placed in Class III, requiring premarket approval.

510(k)

When a 510(k) clearance is required, we must submit a premarket notification demonstrating that our proposed device is substantially equivalent to a previously cleared 510(k) device or a device that was in commercial distribution. The evidence required to prove substantial equivalence varies with the risk posed by the device and its complexity. By regulation, the FDA is required to complete its review of a 510(k) within 90 days of submission of the notification. As a practical matter, clearance often takes longer. The FDA may require further information, including clinical data, to make a determination regarding substantial equivalence. If the FDA determines that the device, or its intended use, is not “substantially equivalent,” the FDA will place the device, or the particular use of the device, into Class III, and the device sponsor must then fulfill much more rigorous pre-marketing requirements, known as pre-market approval (see discussion below).

After a device receives 510(k) clearance for a specific intended use, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, design or manufacture, will require a new 510(k) clearance or could require a Pre-Market Approval application, or PMA approval. The FDA requires each manufacturer to make this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. If the FDA disagrees with a manufacturer’s determination that a new clearance or approval is not required for a particular modification, the FDA can require the manufacturer to cease marketing and recall the modified device until 510(k) clearance or a PMA approval is obtained. Also, in these circumstances, the manufacturer may be subject to significant regulatory fines or penalties.

Pre-Market Approval

If an applicant is unable to demonstrate that a product candidate is substantially equivalent to a marketed device, the FDA will require the submission and approval of a PMA application before marketing of the product. The FDA will approve a PMA only if the applicant provides the FDA with a reasonable assurance that the product is safe and effective when used in accordance with its proposed labeling. The PMA review process includes analysis of manufacturing processes, inspection of manufacturing facilities, and a comprehensive review of pre-market data.

A PMA application must be supported by extensive data, including data from preclinical studies and human clinical trials, and must contain a full description of the device and its components, a full description of the methods, facilities and controls used for manufacturing, and proposed labeling.

After the FDA determines that a PMA application is sufficiently complete to permit a substantive review, the FDA will file the application and begin an in-depth review. The FDA, by statute, has 180 days to review a PMA application, although the review generally occurs over a significantly longer period of time, and can take up to several years. During this review period, the FDA may request additional information or clarification of information already provided. Also during the review period, an advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the

 

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approvability of the device. In addition, the FDA will conduct a preapproval inspection of the manufacturing facility to ensure compliance with the FDA’s Quality System Regulations. New PMA applications or supplemental PMA applications are required for significant modifications to the manufacturing process, labeling, intended use and design of a device that is approved through the pre-market approval process. Pre-market approval supplements often require submission of the same type of information as a PMA application, except that the supplement is limited to information needed to support any changes from the device covered by the original PMA application, and may not require as extensive clinical data or the convening of an advisory panel.

Clinical Trials

A clinical trial is almost always required to support a PMA application and, to a much lesser extent, to support a 510(k) pre-market notification. When FDA approval of a device requires human clinical trials, and if the clinical trial presents a “significant risk” to human health, the device sponsor is required to file an investigational device exemption, or IDE, application with the FDA and obtain IDE approval prior to commencing the human clinical trial. The IDE application must be supported by appropriate data, such as animal and laboratory testing results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound. Clinical trials for a significant risk device may begin once the IDE application is approved by the FDA and the IRB, overseeing the clinical trial. If the product is deemed a “non-significant risk” device, FDA approval is not required, but informed consent and approval from the IRB overseeing the clinical trial is required. Clinical trials are subject to extensive recordkeeping and reporting requirements. Clinical trials must be conducted under the oversight of an IRB at the relevant clinical trials site and in accordance with applicable regulations and policies including, but not limited to, the FDA’s good clinical practice, or GCP, requirements. The applicant, the FDA or the IRB at each site at which a clinical trial is being performed may suspend a clinical trial at any time for various reasons, including a belief that the risks to study subjects outweigh the anticipated benefits. The results of clinical testing may not be sufficient to obtain approval of a product.

Our Device Candidates

In April 2007, we submitted a 510(k) premarket notification for NeutroPhase for wound irrigation and other possible uses. In addition, we believe any medical device coated with NVC-422 or any other Aganocide compound will be regulated as a class III device and will require a PMA submission. We also believe that certain uses of a solution containing NVC-422 may be classified as a medical device.

Continuing Food and Drug Administration Regulation of Medical Devices

After the FDA permits a device to enter commercial distribution, numerous regulatory requirements apply. These include:

 

   

the FDA’s Quality Systems Regulations, or QSRs, which require manufacturers to follow stringent design, testing, production, control, labeling, packaging, storage, shipping, documentation and other quality assurance procedures during all aspects of the manufacturing process;

 

   

labeling regulations which impose restrictions on labeling and promotional activities, and FDA prohibitions against the promotion of products for uncleared, unapproved, or “off-label” uses;

 

   

post-market surveillance requirements which apply when necessary to protect the public health or to provide additional safety and effectiveness data for the device;

 

   

the FDA Medical Device Reporting regulations, which require that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur; and

 

   

notices of correction or removal, and recall regulations.

 

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In addition, we will be required to register our facility and list our products with the FDA, and we will be subject to unannounced inspections by the FDA and the Food and Drug Branch of the California Department of Health Services to determine compliance with the QSR and other regulations, and these inspections may include the manufacturing facilities of our subcontractors. We have never undergone a regulatory inspection and cannot assure you we will pass such an inspection in the future.

Promotional Issues

Physicians may prescribe legally available drugs or devices for an indication that has not been approved by the FDA—a so-called “off-label use.” The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA and other governmental agencies do, however, restrict communications on the subject of off-label use by a manufacturer or those acting on behalf of a manufacturer. Companies may not promote FDA-approved drugs or devices for off-label uses. The FDA and other governmental agencies actively enforce laws and regulations prohibiting promotion of off-label uses and the promotion of products for which marketing clearance has not been obtained.

International Regulation

In addition to being subject to the laws and regulations in the United States, we will be subject to a variety of laws and regulations in those other countries in which we seek to study and commercialize products. European and Canadian regulatory requirements and approval processes are similar in principle to those in the United States. Whether or not we obtain FDA approval for a product, we must obtain approval of a product by the comparable regulatory authorities of the European Union, European countries, Canada and other countries before we can commence clinical trials or marketing of the product in those respective countries. The approval process may be longer or shorter than that required for FDA approval. The requirements governing pricing, reimbursement, clinical trials, and to a lesser extent, product licensing vary from country to country.

In the European Union, there are two ways that a company can obtain multi-state marketing authorization for a pharmaceutical product. The first route is the “centralized procedure.” This procedure is compulsory for certain pharmaceutical products, in particular pharmaceutical products derived from biotechnology, but is also available for pharmaceutical products containing a new active substance or whose applications constitute a significant innovation. Under this procedure the applicant nominates a rapporteur, who is the co-coordinator for the evaluation of an application for marketing authorization, and co-rapporteur. A marketing authorization granted under the centralized procedure is valid in all Member States of the European Union. The second route to obtain marketing authorization in the European Union is the “mutual recognition procedure.” Application is made in all the Member States in which the marketing of the product is sought but the applicant chooses one Member State to act as the “reference Member State” and to prepare an assessment report. Within 90 days of receipt of such report, each Member State applied to may object to the approval if it believes the product raises a potential serious risk to public health. If the Member States do not reach an agreement on whether the approval should be granted or rejected, the matter is referred to the European Union relevant authority whose opinion is then forwarded to the European Commission. The European Commission makes the ultimate decision, which in most cases follows the European Union relevant authority’s opinion.

To obtain marketing approval in Canada, we must provide Canada’s Therapeutic Products Directorate with clinical data that demonstrates safety and efficacy for the new indications in humans. The data is provided in a new drug submission or in a supplemental new drug submission. We cannot market an Aganocide product for new indications in Canada until a supplemental new drug submission is approved by the Therapeutic Products Directorate. If the Therapeutic Products Directorate approves a supplemental new drug submission, the Therapeutic Products Directorate issues a marketing approval, known as a notice of compliance, for the new indications.

 

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Third Party Reimbursement and Pricing Controls

In the United States and elsewhere, sales of pharmaceutical products depend in significant part on the availability of reimbursement to the consumer from third party payors, such as government and private insurance plans. Third party payors are increasingly challenging the prices charged for medical products and services. It will be time consuming and expensive for us to go through the process of seeking reimbursement from Medicare and private payors. Aganocide products from which we may receive revenue in the future may not be considered cost-effective, and reimbursement may not be available or sufficient to allow these products to be sold on a competitive and profitable basis.

In many foreign markets, including Canada and the countries in the European Union, pricing of some pharmaceutical products, in particular reimbursed products, is subject to governmental control. In the European Union, a product must receive specific country pricing approval in order to be reimbursed in that country. The pricing approval in the Member States of the European Union can take many months, and, in certain circumstances, sometimes years, to obtain. In Canada, pricing of patented medicines must be approved by the Patented Medicine Prices Review Board. In addition, the provincial governments have the authority to assess the reimbursement status, if any, and the price at which they will reimburse newly approved drugs, pharmaceutical products and pharmaceutical product indications. Obtaining price approval from the Patented Medicine Prices Review Board and reimbursement status and price level from provincial governments can take six to twelve months or longer after the receipt of the notice of compliance.

In the United States, there have been, and we expect that there will continue to be, a number of federal and state proposals to implement similar governmental pricing control. The adoption of such proposals could harm our business and financial condition.

Anti-Kickback and False Claims Laws

In the United States, we are subject to various federal and state laws pertaining to healthcare “fraud and abuse,” including anti-kickback and false claims laws. The federal Anti-Kickback Law makes it illegal for any person, including a prescription drug manufacturer (or a party acting on its behalf) to knowingly and willfully solicit, offer, receive or pay any remuneration, directly or indirectly, in exchange for, or to induce, the referral of business, including the purchase, order or prescription of a particular drug or device, for which payment may be made under federal healthcare programs such as Medicare and Medicaid. The federal government has issued regulations, commonly known as safe harbors that set forth certain provisions which, if fully met, will assure healthcare providers and other parties that they will not be prosecuted under the federal Anti-Kickback Law. Although full compliance with these provisions ensures against prosecution under the federal Anti-Kickback Law, the failure of a transaction or arrangement to fit within a specific safe harbor does not necessarily mean that the transaction or arrangement is illegal or that prosecution under the federal Anti-Kickback Law will be pursued. Violations of the law are punishable by up to five years in prison, criminal fines, administrative civil money penalties, and exclusion from participation in federal healthcare programs. In addition, many states have adopted laws similar to the federal Anti-Kickback Law. Some of these state prohibitions apply to referral of patients for healthcare services reimbursed by any source, not only the Medicare and Medicaid programs. Due to the breadth of these laws, it is possible that our future sales and marketing practices or our future relationships with physicians might be challenged under anti-kickback laws, which could harm us.

False claims laws prohibit anyone from knowingly presenting, or causing to be presented, for payment to third party payors (including Medicare and Medicaid) claims for reimbursed items or services, including drugs, that are false or fraudulent, claims for items or services not provided as claimed, or claims for medically unnecessary items or services. Our future activities relating to the reporting of wholesaler or estimated retail prices for our products, the reporting of Medicaid rebate information and other information affecting federal, state and third party reimbursement of our products, and the sale and marketing of our products, will be subject to scrutiny under these laws. In addition, pharmaceutical companies have been prosecuted under the federal False Claims Act in connection with their off-label promotion of drugs. Suits filed under the False Claims Act, known

 

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as “qui tam” actions, can be brought by any individual on behalf of the government and such individuals (known as “relators” or, more commonly, as “whistleblowers”) may share in the amounts paid by the entity to the government in fines or settlement.

Penalties for a violation include three times the actual damages sustained by the government, plus mandatory civil penalties of between $5,500 and $11,000 for each separate false claim. In addition, certain states have enacted laws modeled after the federal False Claims Act. If the U.S. government were to allege that we were or our partners were, or convict us or our partners of, violating these false claims laws, we could be harmed, and suffer a decline in our stock price.

Employees

As of March 31, 2007, we had 32 full-time employees, including 14 with doctoral degrees. Of our full time workforce, 24 employees are engaged in research and development, and 8 in finance and administration. None of our employees is represented by labor unions or covered by collective bargaining agreements. We consider our relationship with our employees to be good.

Facilities

Our principal executive offices and our research and development and administrative operations are located in an approximately 11,000 square foot research, development, and administrative facility located in Emeryville, California and in an adjacent facility consisting of approximately 2,600 square feet that we recently leased to accommodate our operations. We have leased our primary facility until October 31, 2009 and the adjacent facility until December 31, 2011. We may seek to expand our facilities to meet our operational requirements within the next twelve months.

Legal Proceedings

We are currently not a party to, nor is our property the subject matter of, any pending or, to our knowledge, contemplated material legal proceedings. From time to time, we may become party to litigation and subject to claims arising in the ordinary course of our business.

 

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MANAGEMENT

Executive Officers and Directors

The following table provides information with respect to our directors and executive officers as of March 31, 2007.

 

Name

  Age   

Position(s)

  

Municipality of Residence

Ramin (“Ron”) Najafi, Ph.D.

  48   

Chairman of the Board, Chief Executive Officer and President

  

Novato, CA; Marin County

John (“Jack”) O’Reilly

  64   

Senior Vice President, Corporate Development, Chief Financial Officer, Treasurer and Director

  

Palo Alto, CA; Santa Clara County

Behzad Khosrovi, Ph.D.

  63   

Vice President, Research and Development

  

El Cerrito, CA; Contra Costa County

Colin Scott, MB, Ch.B.

  55   

Vice President, Clinical Research and Development

  

Discovery Bay, CA; Contra Costa County

Charles J. Cashion(1)*

  56   

Director

  

San Diego, CA; San Diego County

Anthony Dailley, D.D.S.(2)*

  51   

Director

  

Mill Valley, CA; Marin County

Paul E. Freiman(1)(2)(3)*

  72   

Director

  

San Francisco, CA; San Francisco County

T. Alex McPherson, M.D., Ph.D.(2)(3)*

  68   

Director

  

Edmonton, Alberta, Canada

Robert R. Tufts

  73   

Director

  

San Francisco, CA; San Francisco County

Tony Wicks(1)(2)(3)*

  68   

Director

  

Novato, CA; Marin County


 * Independent director, as defined in the AMEX Company Guide
(1) Member of the Audit Committee
(2) Member of the Compensation Committee
(3) Member of the Nominating/Corporate Governance Committee

Ramin (“Ron”) Najafi, Ph.D. has served as our Chairman of the Board and President since July 2002, and as our Chief Executive Officer since November 2004. Prior to joining us, from January 2000 to June 2002, Dr. Najafi served in various management positions with NovaCal Pharmaceuticals, LLC (“NovaCal LLC”), including as Chairman of the Board from January 2000 to June 2002, as President and Chief Scientific Officer from February 2002 to June 2002, and as Chief Executive Officer from January 2000 to February 2002. We acquired all of the assets of NovaCal LLC in July 2002. From 1996 to December 2000, Dr. Najafi was the President and Chief Executive Officer of California Pacific Labs, Inc., a chemical laboratory supplies company. Dr. Najafi’s prior experience also includes serving as a scientist at Aldrich Chemical, Rhone Poulenc Rorer (now Sanofi-Aventis), and at Applied Biosystems (a division of PerkinElmer, Inc.). Dr. Najafi received a B.S. and M.S. degree in Chemistry from the University of San Francisco and a Ph.D. in Organic Chemistry from the University of California at Davis.

John (“Jack”) O’Reilly has served as a director since July 2002 and as our Senior Vice President, Corporate Development, Chief Financial Officer and Treasurer since November 2004. Mr. O’Reilly also served as our Chief Executive Officer from July 2002 to October 2004. From February 2002 to June 2002, Mr. O’Reilly was a director and the Chief Executive Officer of NovaCal LLC. From 2000 to January 2002, he was the Executive Chairman of Xomol Inc., a healthcare information technology company. Mr. O’Reilly’s prior experience also includes several positions at Syntex Corporation, where he served as the Senior Director of Corporate Development, Finance Director of the Pharmaceutical Group and CFO of operating units in France

 

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and Switzerland, as the President of Vectorpharma International, Inc., a drug delivery company which was sold to Recordati S.p.A., a multinational European pharmaceutical company, and as the Chief Executive Officer of Spectra Biomedical, Inc., a clinical genetics company sold to GlaxoSmithKline. Mr. O’Reilly received a B.A. in history from Oxford University and an M.B.A. from Stanford University.

Behzad Khosrovi, Ph.D. has served as our Vice President, Research & Development since November 2003. From 1998 to November 2003, Dr. Khosrovi was a consultant in the biotechnology industry, generally working with start-up companies in the San Francisco Bay Area. Dr. Khosrovi’s prior experience also includes serving as the Vice President of Development at Neurobiological Technologies, Inc. from 1992 to 1998 and at Cetus Corporation from 1976 to 1990. Dr. Kohsrovi received an M.A. in natural science from Cambridge University and a Ph.D. in applied microbiology and biochemical engineering from Manchester University.

Colin Scott, MB, Ch.B. has served as our Vice President, Clinical Research and Development since January 2006. Prior to joining us, from October 2004 to December 2005, Dr. Scott was the Vice President, Drug Development for GlycoMimetics, a biotech company that specializes in the modification of carbohydrate/protein interactions. From June 2004 to September 2004, Dr. Scott was a consultant to several biopharmaceutical companies. From September 2002 to May 2004, Dr. Scott served as the Vice President, Clinical and Regulatory at Arriva Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of anti-inflammatory therapies for respiratory indications. From March 2001 to May 2002, he served as the Vice President, Clinical of Emisphere Technologies, Inc., a biopharmaceutical company focused on developing oral forms of injectable drugs. Dr. Scott received a medical degree in pulmonology and infectious diseases from Glasgow University in Scotland.

Charles J. Cashion has served as a director since November 2005. Mr. Cashion currently serves as the Senior Vice President, Finance and Chief Financial Officer of Conatus Pharmaceuticals Inc., a biotechnology start-up company focused in the areas of inflammation and liver disease, which he co-founded with other senior management of Idun Pharmaceuticals, Inc. following the sale of Idun to Pfizer, Inc. in July 2005. From 2001 to July 2005, Mr. Cashion was the Executive Vice President, Chief Financial Officer and Secretary of Idun. Mr. Cashion’s prior experience also includes serving as the Senior Vice President, Chief Financial Officer and Secretary of Quidel Corporation, a publicly owned, medical diagnostics company, and as the Senior Vice President, Finance, Chief Financial Officer, Secretary, and Treasurer of The Immune Response Corporation, a publicly owned biopharmaceutical company. Mr. Cashion received his B.S. in accounting and an M.B.A. in finance from Northern Illinois University.

Anthony Dailley, D.D.S. has served as a director since May 2002. Dr. Dailley is one of our founders and has been involved in a number of start-up companies, including serving as a director of NovaCal LLC from January 2000 to May 2002. Dr. Dailley currently serves as the President of Breathcare, a specialty dental practice which he founded in 2000. From 1995 to 2000, he was the Treasurer and a member of the board of directors of Indicator Technologies, Inc., a medical device company in California. From 1985 to 1987, he was a co-owner of 1-800-DENTIST, a dentist referral service which he co-founded. Dr. Dailley also held a teaching position at the University of the Pacific School of Dentistry for a number of years. Dr. Dailley received his B.S. in cell and molecular biology from San Francisco State University and his dental degree from the University of the Pacific School of Dentistry in San Francisco.

Paul E. Freiman has served as a director since May 2002. He also served as a director of NovaCal LLC from May 2001 to May 2002. Since May 1997, Mr. Freiman has been the President and Chief Executive Officer of Neurobiological Technologies, Inc., a biotechnology company focused on acquiring and developing central nervous system related drug candidates. He has also served as a member of the board of directors of Nerubiological Technologies since April 1997. Mr. Freiman’s prior experience includes serving as the former chairman and chief executive officer of Syntex Corporation, which was sold to The Roche Group for $5.3 billion during his tenure. Mr. Freiman currently serves as Chairman of Penwest Pharmaceutical Co., and serves on the boards of Calypte Biomedical Corporation, NeoPharm, Inc., Otsuka America Pharmaceuticals, Inc., and SciGen

 

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Ltd. Mr. Freiman received a B.S. degree in pharmacy from Fordham University and an honorary doctorate from the Arnold & Marie Schwartz College of Pharmacy.

T. Alex McPherson, M.D., Ph.D. has served as a director since July 2006. Dr. McPherson was President and Chief Executive Officer of Biomira, Inc., a biotechnology company specializing in the development of products for the treatment of cancer, from 1991 until his retirement in May 2006. He is a Fellow of the Australasian, Canadian and American Colleges of Physicians and is a past President of both the Alberta and Canadian Medical Associations. Dr. McPherson is currently a Professor Emeritus in the Faculty of Medicine of the University of Alberta, and was Deputy Minister of the Alberta Ministry of Hospitals and Medical Care, and was Deputy Commissioner and Executive Director of the Premier’s Commission on Future Health Care for Albertans (The Rainbow Report). Dr. McPherson received his M.D. in medicine from the University of Alberta and his Ph.D. from the University of Melbourne.

Robert R. Tufts has served as a director since May 2002. He also served as a director of NovaCal LLC from February 2001 to May 2002. Mr. Tufts is a founding law partner of Tufts Stephenson & Kasper, LLP, which he founded in April 1999, and was formerly a partner with Jackson Tufts Cole and Black, LLP for over 35 years. He specializes in corporate representation for start-up and emerging businesses, business financings, mergers and acquisitions, and in corporate taxation. Mr. Tufts received his B.A. in history from New York University and received his law degree from Harvard Law School.

Tony Wicks has served as a director since May 2002. He also served as a director of NovaCal LLC from March 2001 to May 2002. Since 1995, Mr. Wicks has been pursuing private investments, venture work and participating in property investments. Prior to that, from 1986 to 1995, Mr. Wicks was the Chief Executive Officer of American Resource Corporation Inc., a public company in the mining industry with activities in North & South America. Prior to that, he served as the Chief Executive Officer of several public and private companies in Europe and the U.S. and was directly involved in company start-up operations, and with public listings. Mr. Wicks received his H.N.C. in electrical engineering from Essex Polytechnic.

Classified Board of Directors

Our Board of Directors currently consists of eight members. All directors hold office until their successors have been elected and qualified or until their earlier death, resignation, disqualification or removal. Effective upon the closing of this offering, we will divide the terms of office of the directors into three classes:

 

   

Class I, whose term will expire at the annual meeting of shareholders to be held in 2008;

 

   

Class II, whose term will expire at the annual meeting of shareholders to be held in 2009; and

 

   

Class III, whose term will expire at the annual meeting of shareholders to be held in 2010.

Upon the closing of this offering, Class I shall consist of Messrs. Dailley, O’Reilly and Tufts; Class II shall consist of Messrs. McPherson, Wicks and Cashion; and Class III shall consist of Messrs. Freiman and Najafi. At each annual meeting of shareholders after the initial classification, the successors to directors whose terms will then expire serve from the time of election and qualification until the third annual meeting following their election and until their successors are duly elected and qualified. A resolution of the Board of Directors or affirmative vote of at least 66  2 / 3 % of our outstanding voting stock may change the authorized number of our directors. Any additional directorships resulting from an increase in the number of directors will be distributed among the three classes so that, as nearly as possible, each class will consist of one third of the directors. This classification of the Board of Directors may have the effect of delaying or preventing changes in control or management of our company.

 

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Board Committees

Our Board of Directors has an Audit Committee, a Compensation Committee and a Nominating/Corporate Governance Committee.

Audit Committee. Our Audit Committee consists of Messrs. Cashion, Freiman and Wicks. All members of the Audit Committee are independent directors, as defined in the AMEX Company Guide. Mr. Cashion is the chairman of the committee and qualifies as an “audit committee financial expert” within the meaning of Item 407(d)(5) of Regulation S-K under the Securities Exchange Act of 1934, as amended. The functions of this committee include:

 

   

meeting with our management periodically to consider the adequacy of our internal controls and the objectivity of our financial reporting;

 

   

meeting with our independent auditors and with internal financial personnel regarding these matters;

 

   

pre-approving audit and non-audit services to be rendered by our independent auditors;

 

   

recommending to our Board of Directors the engagement of our independent auditors and oversight of the work of our independent auditors;

 

   

reviewing our financial statements and periodic reports and discussing the statements and reports with our management, including any significant adjustments, management judgments and estimates, new accounting policies and disagreements with management;

 

   

establishing procedures for the receipt, retention and treatment of complaints received by us regarding accounting, internal accounting controls and auditing matters;

 

   

reviewing our financing plans and reporting recommendations to our full Board of Directors for approval and to authorize action; and

 

   

administering and discussing with management and our independent auditors our Code of Ethics.

Both our independent auditors and internal financial personnel regularly meet privately with the Audit Committee and have unrestricted access to this committee.

Compensation Committee. Our Compensation Committee currently consists of Messrs. Wicks, Dailley, Freiman and McPherson. Mr. Wicks is the chairman of the committee and all members of the Compensation Committee are independent directors, as defined in the AMEX Company Guide. The functions of this committee include:

 

   

reviewing and, as it deems appropriate, recommending to our Board of Directors, policies, practices and procedures relating to the compensation of our directors, officers and other managerial employees and the establishment and administration of our employee benefit plans;

 

   

exercising authority under our employee benefit plans;

 

   

reviewing and approving executive officer and director indemnification and insurance matters; and

 

   

advising and consulting with our officers regarding managerial personnel and development.

Nominating/Corporate Governance Committee. Our Nominating/Corporate Governance Committee is comprised of Messrs. McPherson, Freiman and Wicks. Mr. McPherson is the chairman of the committee and all members of the Nominating/Corporate Governance Committee are independent directors, as defined in the AMEX Company Guide. The functions of this committee include:

 

   

identifying qualified candidates to become members of our Board of Directors;

 

   

selecting nominees for election of directors at the next annual meeting of shareholders (or special meeting of shareholders at which directors are to be elected);

 

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selecting candidates to fill vacancies of our Board of Directors;

 

   

developing and recommending to our Board of Directors our corporate governance guidelines; and

 

   

overseeing the evaluation of our Board of Directors.

Corporate Cease Trade Orders and Bankruptcies

To our knowledge, after due inquiry, none of our directors or officers or any shareholder holding sufficient securities of NovaBay to affect materially the control of NovaBay, is, or has been within the ten years before the date of this prospectus, a director or officer of any other company that, while such person was acting in that capacity, was the subject of a cease trade or similar order, or an order that denied such company access to any statutory exemptions under Canadian securities legislation, for a period of more than 30 consecutive days, or became bankrupt, made a proposal under any legislation relating to bankruptcy or insolvency or was subject to or instituted any proceedings, arrangement or compromise with creditors or had a receiver, receiver manager or trustee appointed to hold the assets of that company.

Penalties and Sanctions

To our knowledge, after due inquiry, none of our directors or officers or any shareholder holding sufficient securities of NovaBay to affect materially the control of NovaBay has been subject to any penalties or sanctions imposed by a court relating to Canadian securities legislation or by a Canadian securities regulatory authority or has entered into a settlement agreement with a Canadian securities regulatory authority or been subject to any other penalties or sanctions imposed by a court or regulatory body that would likely be considered important to a reasonable investor in making an investment decision.

Personal Bankruptcies

To our knowledge, after due inquiry, none of our directors or officers, other than Colin Scott, or any shareholder holding sufficient securities of NovaBay to affect materially the control of NovaBay or a personal holding company of any such persons has, within the ten years before the date of this prospectus, become bankrupt, made a proposal under any legislation relating to bankruptcy or insolvency or been subject to or instituted any proceedings, arrangement or compromise with creditors, or had a receiver, receiver manager or trustee appointed to hold the assets of the director or officer or shareholder.

Conflicts of Interest

NovaBay’s directors and officers are required by law to act honestly and in good faith with a view to the best interests of NovaBay. To the best of our knowledge, there are no known existing or potential conflicts of interest among NovaBay, our directors, officers or other members of management of NovaBay as a result of their outside business interests as of the date hereof. However, certain of our directors and officers and other members of our management serve as directors, officers, and members of management of other public companies. Accordingly, conflicts of interest may arise between their duties to us and their duties as directors, officers or members of management of such other public companies or in generally acting on behalf of NovaBay.

The directors and officers of NovaBay have been advised of their obligations to act at all times in good faith in the interest of NovaBay and to disclose any conflicts to NovaBay if and when they arise. Persons considering the purchase of shares of our common stock pursuant to the offering under this prospectus must appreciate that they will be required to rely on the judgment and good faith of these persons in resolving any such conflicts of interest that may arise.

 

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Indebtedness of Directors and Executive Officers

As of the date of this prospectus, no amount was owed to us by any of our directors or executive officers.

Compensation Committee Interlocks and Insider Participation

None of the members of our Compensation Committee has been at any time one of our officers or employees. None of our executive officers currently serves, or in the past year has served, as a member of the Board of Directors or Compensation Committee of any entity that has one or more executive officers on our Board of Directors or Compensation Committee.

Scientific Advisory Board

The members of our Scientific Advisory Board, none of whom are our officers or employees of NovaBay, provide advice, assistance and consultation in their fields to our Vice-President of Research and Development and our Chief Executive Officer. We have entered into scientific advisory board agreements with our advisory board members. We consider our advisory board members to be opinion leaders in their respective fields. At least once a year, the Scientific Advisory Board will meet to review our current and planned scientific activities and will, through an independent member of the Board of Directors, provide the Board of Directors with an independent assessment of those activities.

As of March 31, 2007, our Scientific Advisory Board consisted of the following members:

 

Name

 

Title

  

Affiliation

Bernard Churchill, M.D.   Professor of Urology & Chief, Division of Pediatric Urology    David Geffen School of Medicine at University of California, Los Angeles
William Costerton, Ph.D.   Director of Biofilm Engineering    University of Southern California
Frederick Hawthorne, Ph.D.   Co-Director, International Institute for Nano and Molecular Medicine    University of Missouri-Columbia
Larry Truesdale, Ph.D.   Director of Combinatorial Chemistry    Pfizer, Inc.
Roger Whiting, Ph.D.   President and Chief Scientific Officer    Roxro Pharma, Inc.

Compensation Discussion and Analysis

The primary objective of our compensation policies and programs with respect to executive compensation is to serve our shareholders by attracting, retaining and motivating talented and qualified individuals to manage and lead our business. We focus on providing a competitive compensation package which provides significant short and long-term incentives for the achievement of measurable corporate and individual performance objectives. Decisions regarding executive compensation are ultimately determined by our Compensation Committee, who review a number of factors in their decisions, including recommendations of management. Future decisions regarding executive compensation will continue to be the responsibility of our Compensation Committee.

In 2006, we paid our senior management through a mix of base salary, bonus and equity compensation at levels that we believed were comparable to executives of companies of similar size and stage of development. As a private company, our compensation plans were generally developed by our management and approved by our Board and Compensation Committee on an individual basis, utilizing a number of factors including publicly available data and our general business conditions and objectives. We expect that in the future, we may engage the services of compensation consultants to review our policies and procedures with respect to executive

 

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compensation, or conduct annual benchmark reviews of our executive compensation or subscribe to various surveys or reports to assist us in setting appropriate levels of compensation for our executives.

Elements of Executive Compensation

Base Salary

We seek to provide our senior management with a level of base salary in the form of cash compensation appropriate to their roles and responsibilities. Base salaries for our executives are established based on the executive’s qualifications, experience, scope of responsibilities, future potential and past performance, as well as the salaries paid by other companies for similar positions. Base salaries are reviewed annually and adjusted from time to time to realign salaries with market levels after taking into account individual responsibilities, performance and experience.

Incentive Cash Bonuses

Our practice is to award incentive cash bonuses to our executive officers based upon their individual performance as well as business and strategic objectives of the Company. In 2006, bonuses were awarded to our executive officers primarily based on their contributions to achieving specific development and other business goals. The Compensation Committee expects to adopt formal processes for incentive cash bonuses in 2007 and beyond, and intends to utilize incentive cash bonuses to reward executives for achieving financial and operational goals and for achieving individual performance objectives.

Long-Term Equity Compensation

We believe that long-term performance is achieved through an ownership culture that encourages long-term performance by our executive officers through the use of stock-based awards. We have established equity incentive plans to provide our employees, including our executive officers, with incentives to help align those employees’ interests with the interests of shareholders. We normally grant our executive officers stock options upon their commencement of employment with us, which generally vest over a four year period, to provide a long-term incentive to such officers, provide them with an opportunity to obtain an ownership interest in our company and further align their interests with the interests of our shareholders. In 2006, we granted Colin Scott, one of our executive officers, an option to acquire 200,000 shares of our common stock. The Compensation Committee believes that the use of stock and stock-based awards promotes our overall executive compensation objectives and expects that equity incentives will continue to be a significant source of compensation for our executives.

Historically, we have issued stock options, which may be exercised prior to vesting and converted into restricted stock. The stock options that we grant generally vest as to 25% of the shares underlying the grant on the first anniversary of the grant date, with the remainder vesting in 12 equal quarterly installments thereafter over the three year period beginning on the first anniversary of the date of grant. In addition, these stock options generally will have a maximum term of ten years. We have not had a formalized policy as to the amount or timing of grants to executive officers. The Compensation Committee expects any future grants will be made on a structured and systematic basis, based on a number of factors, including individual performance, benchmark data, our strategic goals and our financial condition.

Other Compensation

Our executive officers are eligible to receive the same benefits, including non-cash group life and health benefits, that are available to all employees. Certain additional benefits may be provided to our executives such as a car allowance, but each on a case-by-case basis.

 

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Summary Compensation Table

The following table shows information regarding the compensation earned during the fiscal years ended December 31, 2004, 2005 and 2006 by our Chief Executive Officer, Chief Financial Officer and our two other executive officers who were serving in such capacities during fiscal years 2004, 2005 and 2006. The officers listed below are collectively referred to as the “Named Executive Officers” in this prospectus.

 

Name

      Year           Salary           Bonus       Options
Awards(1)
  All Other
Compensa-
tion(2)
  Total

Ramin (“Ron”) Najafi, Ph.D.

Chairman of the Board, CEO and President

  2006
2005
2004
  $
 
 
240,000
200,000
200,000
  $
 
 
48,000
—  
—   
  $
 

 
—  
—  

—  
  $
 
 
25,691
—  
—  
  $
 
 
313,691
200,000
200,000

John (“Jack”) O’Reilly

Sr. VP, Corporate Development and CFO

  2006
2005
2004
   
 
 
198,500
152,000
198,200
   
 
 
33,750
—  
—  
   
 
 
—  
—  
—  
   
 
 
14,482
—  
—  
   
 
 
246,732
152,000
198,200

Behzad Khosrovi, Ph.D.

VP, Research and Development

  2006
2005
2004
   
 
 
172,200
150,000
154,800
   
 
 
31,219
—  
—  
   
 
 
—  
—  
—  
   
 
 
12,202
—  
—  
   
 
 
215,621
150,000
154,800

Colin Scott, MB, ChB

VP, Clinical Research and Development(3)

  2006
2005
2004
   
 
 
195,800
—  
—  
   
 
 
20,000
—  
—  
   
 
 
25,721
—  
—  
   
 
 
—  
—  
—  
   
 
 
241,521
—  
—  

(1) Valuation of awards based on the recognized expense for fiscal year 2006, determined pursuant to SFAS No. 123R utilizing assumptions discussed in Note 8 to our financial statements. No expense was recognized in fiscal years 2004 or 2005 in accordance with the prospective application transition method prescribed by SFAS No. 123R.
(2) These amounts represent cash compensation for accrued and unused vacation leave entitlements.
(3) Mr. Scott was not employed by us prior to fiscal year 2006.

Grants of Plan-Based Awards

Executive officers were awarded incentive stock options, to the extent permissible under the Internal Revenue Code. The exercise price per share of each option granted to our Named Executive Officers was determined in good faith by our Board of Directors to be equal to the fair market value of our common stock on the date of the grant. All options were granted under our 2002 Stock Option Plan and 2005 Stock Option Plan and are immediately exercisable. Except as otherwise noted below, the stock options vest as to 25% of the shares underlying the grant on the first anniversary of the grant date, with the remainder vesting in 12 equal quarterly installments thereafter over the three year period following the first anniversary of the date of grant. For a further description of our 2002 Stock Option Plan and 2005 Stock Option Plan, see “—Employee Benefit Plans.”

 

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The following table presents information concerning grants of plan-based awards to each of the Named Executive Officers during fiscal years 2004, 2005 and 2006.

 

Name

  Grant Date   All Other Option
Awards: Number
of Securities
Underlying
Options (#)
    % of
Total
Options
Granted
in Year
    Exercise or Base
Price of Option
Awards ($/Sh)
  Grant Date Fair
Value of Stock and
Option Awards(1)
  Expiration
Date

Ramin (“Ron”) Najafi, Ph.D.

Chairman of the Board, CEO and President

  —     —       —       $ —     $ —     —  

John (“Jack”) O’Reilly

Sr. VP, Corporate Development and CFO

  —     —       —         —       —     —  

Behzad Khosrovi, Ph.D.

VP, Research and Development

  1/29/04   400,000 (2)   31 %     0.15     —     1/29/14

Colin Scott, MB, ChB

VP, Clinical Research and Development

  1/17/06   200,000 (3)   12 %     0.60     83,279   1/17/16

(1) Valuation of awards granted in fiscal year 2006 is based on the grant date fair value of the awards, determined pursuant to SFAS No. 123R utilizing assumptions discussed in Note 8 to our financial statements. No grant date fair value is provided for awards granted in fiscal years 2004 and 2005 in accordance with the prospective application transition method prescribed by SFAS No. 123R.
(2) In January 2004, Dr. Khosrovi was granted an option to purchase an aggregate of 400,000 shares of our common stock. 50,000 shares subject to such option were fully vested as of the date of grant. The remaining shares vest in accordance with the following schedule: (i) 100,000 shares vest upon our first IND for the NVC-101 product if filed before December 1, 2013; (ii) 50,000 shares vest upon completion of our Phase I and II clinical trials for the NVC-101 product if completed before December 1, 2013; and (iii) the remaining 200,000 shares vest in four equal quarterly installments over the one year period commencing with the end of the calendar quarter following completion of our Phase I and II clinical trials for the NVC-101 product. As of December 31, 2006, the option was vested with respect to 200,000 shares.
(3) In January 2006, Mr. Scott was granted an option to purchase an aggregate of 200,000 shares of our common stock. The option vests in equal quarterly installments over four years on the first day of each quarter, provided that Mr. Scott continues to provide services to us. As of December 31, 2006, the option was vested with respect to 50,000 shares.

 

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Outstanding Equity Awards at Fiscal Year-End

The following table presents the outstanding equity awards held by each of the Named Executive Officers as of the fiscal year ended December 31, 2006.

 

      Option Awards

Name

                  Value of Unexercised
In-the-Money Options(1)
       
  Number of
Securities
Underlying
Unexercised
Options(#)
Exercisable
    Number of
Securities
Underlying
Unexercised
Options(#)
Unexercisable
  Equity Incentive
Plan Awards:
Number of
Securities
Underlying
Unexercised
Unearned
Options (#)
    Exercisable   Unexercisable   Option
Exercise
Price
($)
  Option
Expiration
Date

Ramin (“Ron”) Najafi, Ph.D.

Chairman of the Board, CEO and President

  —       —     —       $ —     $ —     $ —     —  

John (“Jack”) O’Reilly

Sr. VP, Corporate Development and CFO

  600,000
106,383
(2)
(3)
  —  
—  
  100,000
—  
(2)
 
     
 
—  
—  
   
 
0.10
0.47
  2/21/12
1/22/09

Behzad Khosrovi, Ph.D.

VP, Research and Development

  200,000 (4)   —     200,000 (4)       —       0.15   1/29/14

Colin Scott, MB, ChB

VP, Clinical Research and Development

  200,000 (5)   —     —           —       0.60   1/17/16

(1) The value of unexercised in-the-money options listed above have been calculated on the basis of the assumed initial public offering price of $            , less the applicable exercise price per share, multiplied by the number of shares underlying such options.
(2) In May 2002, Mr. O’Reilly was granted an option to purchase an aggregate of 700,000 shares of our common stock. 100,000 shares subject to such option were fully vested as of the date of grant. The remaining 600,000 shares vest in equal 100,000 share increments upon NovaBay’s achieving each of the following: (i) raising an initial $1,000,000 of capital in an equity financing; (ii) filing an IND; (iii) raising a second $1,000,000 of capital in an equity financing; (iv) receiving clearance for the filed IND; (v) entering into a significant partnership agreement with another company for the development or exploitation of NovaBay products or intellectual property; and (vi) entering into a second significant partnership agreement with another company for the development or exploitation of NovaBay products or intellectual property before January 2010. As of December 31, 2006, the option was vested with respect to 600,000 shares and 100,000 shares were subject to vesting conditions.
(3) The option was fully vested as to all shares upon the date of grant.
(4) In January 2004, Dr. Khosrovi was granted an option to purchase an aggregate of 400,000 shares of our common stock. 50,000 shares subject to such option were fully vested as of the date of grant. The remaining shares vest in accordance with the following schedule: (i) 100,000 shares vest upon our first IND for the NVC-101 product if filed before December 1, 2013; (ii) 50,000 shares vest upon completion of our Phase I and II clinical trials for the NVC-101 product if completed before December 1, 2013; and (iii) the remaining 200,000 shares vest in four equal quarterly installments over the one year period commencing with the end of the calendar quarter following completion of our Phase I and II clinical trials for the NVC-101 product. As of December 31, 2006, the option was vested with respect to 200,000 shares.
(5) In January 2006, Mr. Scott was granted an option to purchase an aggregate of 200,000 shares of our common stock. The option vests in equal quarterly installments over four years on the first day of each quarter, provided that Mr. Scott continues to provide services to us. As of December 31, 2006, the option was vested with respect to 50,000 shares.

 

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Option Exercises and Stock Vested

None of the Named Executive Officers exercised any options to purchase our common stock or became vested in restricted stock during the year ended December 31, 2006.

Pension Benefits

We do not have any qualified or non-qualified defined benefit plans.

Non-Qualified Deferred Compensation

We do not have any non-qualified defined contribution plans or other deferred compensation plans.

Employment Contracts and Termination of Employment and Change of Control Arrangements

We intend to enter into an employment agreement with each of our Named Executive Officers prior to the completion of this offering.

Mr. O’Reilly was granted a stock option in May 2002 to purchase up to 700,000 shares of our common stock at an exercise price of $0.10 per share. Mr. Scott was granted a stock option in January 2006 to purchase up to 200,000 shares of our common stock at an exercise price of $0.60 per share. Upon a change in control of NovaBay, all unvested shares subject to the foregoing options will immediately vest and will remain exercisable until the expiration of the applicable option.

Mr. Khosrovi, our Vice President of Research and Development, was granted a stock option in January 2004 to purchase up to 400,000 shares of our common stock at an exercise price of $0.15 per share. Upon a change in control of NovaBay, all unvested option shares will immediately vest and will remain exercisable until the expiration of such option. The option will also vest in full upon the completion of this offering.

Director Compensation

The compensation and benefits for services as a member of our Board of Directors is determined by our Board of Directors. Directors employed by us are not compensated for service on the Board or any committee of the Board; however, we reimburse all directors for any out-of-pocket expenses incurred in connection with attending meetings of our Board of Directors and committees of our Board of Directors.

In March 2007, our Board of Directors approved a director compensation plan for the years 2007, 2008 and 2009 (the “Directors Plan”), which was approved by our stockholders in April 2007 and will become effective upon completion of this offering. Under the Directors Plan, our non-employee directors will receive cash and shares of our common stock for each meeting of the Board and for each meeting of a committee of the Board that such director attends, up to the maximums set forth below. The number of shares of common stock actually received for any meeting will be based on the market value of the stock on the date of the meeting, subject to a minimum per share price. The chairpersons of the Compensation Committee and the Audit Committee will receive higher compensation than other members of such committees for attending committee meetings.

 

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The table below sets forth the amounts to be received pursuant to the Directors Plan by the non-employee directors for attending meetings of the Board and of Board committees for the years 2007, 2008 and 2009. For the year 2009, each non-employee director will receive an annual retainer of $6,000 in cash and $9,000 in common stock, in addition to the per meeting compensation.

 

Year   

Board Meetings

  

Chairperson of
Compensation Committee
or Audit Committee

  

Committee Meetings

2007    $1,400 in cash and $2,100 in common stock per meeting (maximum of $8,400 in cash and $12,600 in stock for the year)    $600 in cash and $900 in common stock per meeting (maximum of $3,000 in cash and $4,500 in stock for the year)    $300 in cash and $450 in common stock per meeting (maximum of $1,500 in cash and $2,250 in stock for the year)
2008    $1,800 in cash and $2,700 in common stock per meeting (maximum of $10,800 in cash and $16,200 in stock for the year)    $800 in cash and $1,200 in common stock per meeting (maximum of $4,000 in cash and $6,000 in stock for the year)    $400 in cash and $600 in common stock per meeting (maximum of $2,000 in cash and $3,000 in stock for the year)
2009    $1,800 in cash and $2,700 in common stock per meeting (maximum of $10,800 in cash and $16,200 in stock for the year)    $800 in cash and $1,200 in common stock per meeting (maximum of $4,000 in cash and $6,000 in stock for the year)    $400 in cash and $600 in common stock per meeting (maximum of $2,000 in cash and $3,000 in stock for the year)

Non-employee directors are also eligible to participate in our equity incentive plans and may be granted awards under such plans, at the discretion of our Board. Under the Directors Plan, the Board may grant stock options to newly elected non-employee directors upon their first appointment or election to the Board. If granted, such options will have an exercise price per share equal to the fair market value of our common stock on the date of grant and will vest one-third at the end of the first year and one-twelfth at the end of each calendar quarter after the end of the first year, subject to the director’s continuing service on our Board. Options that have been previously granted to the non-employee directors will continue to vest in accordance with their respective terms.

We currently do not pay, and did not pay in 2006, cash compensation to any of our non-employee directors for their service as a member of the Board of Directors or on any committee of the Board of Directors. The compensation received during 2006 by each director who is not a Named Executive Officer is set forth below.

 

Name

   Option Awards(1)
($)
   Total ($)

Charles J. Cashion

   $ 48,453    $ 48,453

Anthony Dailley

     36,809      36,809

Paul E. Freiman

     26,254      26,254

T. Alex McPherson

     33,592      33,592

Robert R. Tufts

     37,284      37,284

Tony Wicks

     37,284      37,284

(1) Valuation of awards based on the recognized expense for the fiscal year 2006, determined pursuant to SFAS No. 123R utilizing assumptions discussed in Note 8 to our financial statements. The grant date fair values of the options were as follows: $56,938 for each of Messrs. Wicks, Tufts, Dailley and Freiman, and $90,554 and $90,316 for Messrs, McPherson and Cashion, respectively.

Employee Benefit Plans

2002 Stock Option Plan

Our 2002 Stock Option Plan (the “2002 Plan”) was adopted by our Board of Directors in May 2002 and approved by our shareholders in October 2002. A total of 4,500,000 shares of our common stock have been

 

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reserved for issuance under the 2002 Plan. Under the 2002 Plan, we are authorized to grant to officers and other employees options to purchase shares of our common stock intended to qualify as incentive stock options, as defined under Section 422 of the Internal Revenue Code of 1986, as amended (the “Internal Revenue Code”) and are authorized to grant to directors, officers, employees, consultants or independent contractors options that do not qualify as incentive stock options under the Internal Revenue Code. All options granted under the 2002 Plan have terms not exceeding 10 years and generally are immediately exercisable but vest over time. No director, employee, consultant or independent contractor may be granted options to acquire more than 400,000 shares of our common stock in any calendar year under the 2002 Plan. Options granted under the 2002 Plan are not transferable by the recipient except by will or by the laws of descent and distribution. As of March 31, 2007, options to purchase an aggregate of 2,574,716 shares of our common stock were outstanding under the 2002 Plan at a weighted average exercise price of $0.17 per share. Our Board of Directors has determined that no further option grants will be made under the 2002 Plan, but all outstanding options under the 2002 Plan will continue to be governed by the terms and conditions of the 2002 Plan.

2005 Stock Option Plan

Our 2005 Stock Option Plan (the “2005 Plan”) was adopted by our Board of Directors and approved by our shareholders in May 2005. A total of 2,470,000 shares of our common stock have been reserved for issuance under the 2005 plan. Under the 2005 Plan, we are authorized to grant to officers and other employees options to purchase shares of our common stock intended to qualify as incentive stock options, as defined under Section 422 of the Internal Revenue Code, and are authorized to grant to directors, officers employees, consultants or independent contractors options that do not qualify as incentive stock options under the Internal Revenue Code. All options granted under the 2005 Plan have terms not exceeding 10 years and generally are immediately exercisable but vest over time. No one director, employee, consultant or independent contractor may be granted options to acquire more than 750,000 shares of our common stock in any calendar year under the 2005 Plan. Options granted under the 2005 Plan are not transferable by the recipient except by will or by the laws of descent and distribution. As of March 31, 2007, options to purchase an aggregate of 2,045,250 shares of our common stock were outstanding under the 2005 Plan at a weighted average exercise price of $0.85 per share, and 394,750 additional shares of common stock were reserved for future grant or issuance under the 2005 Plan. No further option grants will be made under the 2005 Plan after the date of this prospectus. Although no further options will be granted under the 2005 Plan, all outstanding options under the 2005 Plan will continue to be governed by the terms and conditions of the 2005 Plan.

2007 Omnibus Incentive Plan

Our 2007 Omnibus Incentive Plan (the “Omnibus Plan”) was adopted by our Board of Directors in March 2007 and approved by our stockholders in April 2007 and will become effective upon completion of this offering. The Compensation Committee of our Board of Directors (the “Committee”) has the authority to administer the Omnibus Plan, and it will have full power and authority to determine when and to whom awards will be granted and the type, amount, form of payment and other terms and conditions of each award, consistent with the provisions of the Omnibus Plan. Subject to the provisions of the Omnibus Plan, the Committee may amend or waive the terms and conditions, or accelerate the exercisability, of an outstanding award. The Committee has authority to interpret the Omnibus Plan and establish rules and regulations for the administration of the Omnibus Plan. In addition, our Board of Directors may also exercise the powers granted to the Committee at any time. Any employee, officer, consultant, advisor or director providing services to us or any of our affiliates, who is selected by the Committee, is eligible to receive awards under the Omnibus Plan.

The aggregate number of shares of common stock that may be issued under all stock-based awards made under the Omnibus Plan will be              shares. Additionally, any shares of our common stock subject to any award that is terminated or forfeited will be available for future awards under the Omnibus Plan. The shares of common stock issuable under the Omnibus Plan may be drawn from shares of authorized but unissued common stock or from shares of common stock that we acquire.

 

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Under our Omnibus Plan, the Committee is permitted and authorized to make awards that are denominated or payable in, valued by reference to, or otherwise based on or related to shares of our common stock, including the following:

 

   

Stock Options . The Committee may grant stock options to officers and other employees intended to qualify as incentive stock options, as defined in Section 422 of the Internal Revenue Code of 1986, as amended, and may also grant options to employees, consultants and independent contractors that do not qualify as incentive stock options. The holder of an option will be entitled to purchase a number of shares of our common stock at a specified exercise price during a specified time period, all as determined by the Committee. The shares subject to each option will generally vest in one or more installments over a specified period of service measured from the grant date.

 

   

Stock Appreciation Rights (SAR) . The holder of a SAR is entitled to receive the excess of the fair market value (calculated as of the exercise date or, at the Committee’s discretion, as of any time during a specified period before or after the exercise date) of a specified number of shares of our common stock over the grant price of the SAR, as determined by the Committee, paid solely in shares of common stock. SARs vest and become exercisable in accordance with a vesting schedule established by the Committee.

 

   

Restricted Stock and Restricted Stock Units . The holder of restricted stock will own shares of our common stock subject to restrictions imposed by the Committee (including, for example, restrictions on transferability or on the right to vote the restricted shares or to receive any dividends with respect to the shares) for a specified time period determined by the Committee. The restrictions, if any, may lapse or be waived separately or collectively, in installments or otherwise, as the Committee may determine. The holder of restricted stock units will have the right, subject to any restrictions imposed by the Committee, to receive shares of our common stock at some future date determined by the Committee.

 

   

Performance Awards . Performance awards give participants the right to receive payments in stock or property based solely upon the achievement of certain performance goals during a specified performance period. Subject to the terms of the Omnibus Plan, the performance goals to be achieved during any performance period, the length of any performance period, the amount of any performance award granted, the amount of any payment or transfer to be made pursuant to any performance award and any other terms and conditions of any performance award is determined by the Committee.

 

   

Dividend Equivalents . The holder of a dividend equivalent is entitled to receive payments (in cash, shares of our common stock, other securities, other awards or other property) equivalent to the amount of cash dividends paid by us to holders of our common stock with respect to a number of shares determined by the Committee, subject to terms and conditions determined by the Committee and the Omnibus Plan limitations.

 

   

Stock Awards . The Committee may grant unrestricted shares of our common stock, subject to terms and conditions determined by the Committee and the Omnibus Plan limitations.

The term of awards will not be longer than ten years or, in the case of incentive stock options, not longer than five years with respect to holders of more than 10% of our common stock. The Committee may permit accelerated vesting of an award upon the occurrence of certain events, including a change in control, regardless of whether the award is assumed, substituted or otherwise continued in effect by the successor corporation. The acceleration of vesting in the event of a change in the ownership or control may be seen as an anti-takeover provision and may have the effect of discouraging a merger proposal, a takeover attempt or other efforts to gain control of us.

Unless earlier discontinued or terminated by the Board, the Omnibus Plan will expire in April 2017. No awards may be made after that date. However, unless otherwise expressly provided in an applicable award agreement, any award granted under the Omnibus Plan prior to expiration may extend beyond the end of such period through the award’s normal expiration date.

 

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401(k) Plan

We maintain a tax-qualified retirement plan that provides eligible employees of our Company with an opportunity to save for retirement on a tax-advantaged basis. Eligible employees are able to defer up to the applicable annual Internal Revenue Code limits. The 401(k) plan permits us to make matching contributions and profit sharing contributions to eligible participants, although such contributions are not required. Pre-tax contributions are allocated to each participant’s individual account and are then invested in selected investment alternatives according to the participants’ directions. Employee contributions are 100% vested at all times. The 401(k) plan is intended to qualify under Sections 401(a) and 501(a) of the Internal Revenue Code. As a tax-qualified retirement plan, contributions to the 401(k) plan and earnings on these contributions are not taxable to the employees until distributed from the 401(k) plan and all contributions are deductible by us when made.

Options Held by Officers, Directors, Employees and Consultants

The following table presents summarized information pertaining to options outstanding as of the date of this prospectus.

 

Group

  Number
of
Persons
Holding
Options
   Number
of
Options
   Exercise
Price
   Market
Value on
Date of
Grant(1)
  Expiration Dates

Current and former executive officers

  3    700,000    $ 0.10    $ 0.10   February 21, 2012
     400,000    $ 0.15    $ 0.15   January 29, 2014
     106,383    $ 0.47    $ 0.15   January 22, 2009
     200,000    $ 0.60    $ 0.60   January 17, 2016

Current and former directors who are not executive officers

  6    120,000    $ 0.10    $ 0.10   Various(2)
     120,000    $ 0.15    $ 0.15   December 15, 2013
     395,000    $ 0.28    $ 0.28   April 30, 2014
     709,000    $ 0.85    $ 0.85   Various(3)

All other current and former employees

  29    150,000    $ 0.10    $ 0.10   Various(4)
     100,000    $ 0.15    $ 0.15   Various(5)
     25,000    $ 0.28    $ 0.28   Various(6)
     217,000    $ 0.60    $ 0.60   Various(7)
     290,000    $ 0.85    $ 0.85   Various(8)
     78,000    $ 1.00    $ 1.00   September 14, 2016
     351,250    $ 1.14    $ 1.14   January 17, 2017

Consultants

  38    257,333    $ 0.10    $ 0.10   Various(9)
     135,000    $ 0.15    $ 0.15   Various(10)
     54,000    $ 0.28    $ 0.28   Various(11)
     112,000    $ 0.60    $ 0.60   Various(12)
     278,918    $ 0.85    $ 0.85   March 31, 2015(13)
     25,625    $ 0.94    $ 0.94   March 31, 2015(13)
     7,415    $ 1.14    $ 1.14   December 31, 2007(13)
     90,000    $ 1.14    $ 1.14   January 17, 2017

(1) Because there was no market for our shares, the fair value was determined by our Board of Directors.
(2) From December 31, 2011 to March 18, 2012
(3) From May 24, 2016 to July 10, 2016
(4) From September 1, 2012 to April 15, 2013
(5) From January 29, 2014 to January 31, 2014
(6) From December 12, 2014 to March 31, 2015

 

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(7) From October 30, 2015 to January 17, 2016
(8) From May 24, 2016 to July 18, 2016
(9) From December 31, 2011 to June 30, 2012
(10) From December 31, 2011 to January 30, 2014
(11) From January 6, 2015 to May 12, 2015
(12) From May 12, 2015 to January 17, 2016
(13) Options issued outside of the 2002 and 2005 Plans

Limitation on Liability and Indemnification Matters

As allowed by the California Corporations Code, our amended and restated articles of incorporation eliminate the liability of each of our directors for monetary damages to the fullest extent permissible under California law. Our amended and restated articles of incorporation and our amended and restated bylaws further provide for indemnification of our officers and directors to the maximum extent permitted by California law, and also permit the indemnification of other corporate agents at the discretion of our Board of Directors. We also maintain insurance policies which insure our officers and directors against certain liabilities.

We have entered into agreements to indemnify our directors and certain of our officers in addition to the indemnification provided for in the amended and restated articles of incorporation and amended and restated bylaws. These agreements will, among other things, indemnify our directors and some of our officers for certain expenses (including attorneys fees), judgments, fines and settlement amounts incurred by such persons in any action or proceeding, including any action by or in our right, on account of services by such persons as a director or officer of NovaBay or as a director or officer of any of our subsidiaries, or as a director or officer of any other company or enterprise that persons provide services to at our request.

There is no pending litigation or proceeding naming any of our directors or officers for which indemnification is being sought, nor are we aware of any pending or threatened litigation that may result in claims for indemnification by any director or officer.

 

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RELATED PARTY TRANSACTIONS

Since December 31, 2003, there has not been any transaction, nor is there any proposed transaction, to which we were or will be a party, in which the amount involved exceeded or will exceed $120,000 or which had or will have a material affect on us, and in which any director, executive officer, holder of more than 5% of any class of our voting securities or any associate, affiliate or member of the immediate family of any of the foregoing persons had or will have a direct or indirect material interest, other than the compensation agreements and other agreements and transactions which are described in “Management” and the transactions described below.

Policies and Procedures

Pursuant to the written charter of our Audit Committee, our Audit Committee of the Board of Directors is responsible for reviewing and approving, prior to our entry into any such transaction, all related party transactions and potential conflict of interest situations involving a principal shareholder, a member of the board of directors or senior management. In addition, our Code of Ethics and Business Conduct requires that our officers and employees use good judgment to adhere to high ethical standards with respect to situations that create an actual or potential conflict between such person’s personal interests and the interests of the company.

Transactions with Related Parties

We have entered into, or intend to enter into, indemnification agreements with each of our current directors and executive officers. These agreements will require us to indemnify these individuals to the fullest extent permitted under California law against liabilities that may arise by reason of their service to us, and to advance expenses incurred as a result of any proceeding against them as to which they could be indemnified. We also intend to enter into indemnification agreements with our future directors and executive officers.

 

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PRINCIPAL SHAREHOLDERS

The following table indicates information as of March 31, 2007 regarding the ownership of our common stock by:

 

   

each person who is known by us to own more than 5% of our shares of common stock;

 

   

each Named Executive Officer;

 

   

each of our directors; and

 

   

all of our directors and executive officers as a group.

The number of shares beneficially owned and the percentage of shares beneficially owned are based on 32,204,813 shares of common stock outstanding as of March 31, 2007, which assumes the conversion of all of our outstanding preferred stock into 19,227,195 shares of common stock upon the completion of this offering, and              shares of common stock outstanding upon consummation of this offering. Beneficial ownership is determined in accordance with the rules and regulations of the Securities and Exchange Commission. Shares subject to options that are exercisable within 60 days following March 31, 2007 are deemed to be outstanding and beneficially owned by the optionee for the purpose of computing share and percentage ownership of that optionee, but are not deemed to be outstanding for the purpose of computing the percentage ownership of any other person. Except as indicated in the footnotes to this table, and as affected by applicable community property laws, all persons listed are the shareholders of record and have sole voting and investment power for all shares shown as beneficially owned by them.

 

Name and Address of Beneficial Owners (1)

   Number of
Shares
Beneficially
Owned 
   Percent of Shares
Beneficially Owned
 
      Prior to
Offering
    After
Offering
 

Ramin (“Ron”) Najafi, Ph.D.(2)

   6,249,000    19.4 %       .   %

John (“Jack”) O’Reilly(3)

   806,383    2.4    

Behzad Khosrovi, Ph.D.(4).

   670,000    2.1    

Colin Scott, MB, ChB(3)

   200,000    *    

Charles J. Cashion(3)

   164,000    *    

Anthony Dailley, DDS(5)

   613,208    1.9    

Paul E. Freiman(6)

   330,000    1.0    

T. Alex McPherson, MD, Ph.D.(7)

   159,666    *    

Robert R. Tufts(8)

   455,000    1.4    

Tony Wicks(9)

   469,929    1.4    

All directors and executive officers as a group (10 persons)(10)

   10,117,186        28.9 %       .   %

  * Less than one percent
(1) The address for each of the persons listed is c/o NovaBay Pharmaceuticals, Inc., 5980 Horton Street, Suite 500, Emeryville, California 94608.
(2) Consists of 6,249,000 shares of common stock held by the Najafi Family Trust dated September 13, 2006, of which Dr. Najafi and his spouse are the trustees.
(3) Consists solely of shares issuable upon exercise of outstanding options which are currently exercisable.
(4) Includes 400,000 shares issuable upon exercise of outstanding options which are currently exercisable.
(5) Includes (i) 200,847 shares held by the Anthony and Terry Dailley Trust, of which Mr. Dailley and his spouse are trustees, (ii) 14,361 shares held by the Anthony Dailley DDS Profit Sharing Plan, of which Mr. Dailley is the trustee, and (iii) 248,000 shares issuable upon exercise of outstanding options which are currently exercisable.
(6) Includes 280,000 shares issuable upon exercise of outstanding options which are currently exercisable.

 

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(7) Includes 143,000 shares issuable upon exercise of outstanding options which are currently exerciseable.
(8) Consists of (i) 254,000 shares held by a trust established by Mr. Tufts, of which Mr. Tufts and his spouse are trustees, and (ii) 201,000 shares issuable upon exercise of outstanding options which are currently exercisable.
(9) Consists of (i) 161,929 shares held by the Wicks Revocable Trust, of which Mr. Wicks and his spouse are trustees, and (ii) 308,000 shares issuable upon exercise of outstanding options which are currently exercisable.
(10) Includes 2,750,383 shares of common stock issuable upon exercise of outstanding options which are currently exercisable.

 

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DESCRIPTION OF CAPITAL STOCK

The following description of our securities and provisions of our amended and restated articles of incorporation and amended and restated bylaws is only a summary. You should also refer to the copies of our amended and restated articles and bylaws which have been filed with the Securities and Exchange Commission as exhibits to our registration statement. The description of common stock and preferred stock reflect changes to our capital structure that will occur upon the closing of this offering in accordance with the terms of the amended and restated articles of incorporation that will be adopted by us immediately prior to the closing of this offering.

Upon the closing of this offering, our authorized capital stock will consist of 65,000,000 shares of common stock, par value $0.01 per share, and 5,000,000 shares of preferred stock, par value $0.01 per share.

Common Stock

Currently, we are authorized to issue 64,000,000 shares of common stock. At March 31, 2007, 12,977,618 shares of common stock were deemed outstanding and held of record by 177 holders. Under our amended and restated articles of incorporation and amended and restated bylaws, holders of common stock do not have cumulative voting rights. The shares of common stock offered by this prospectus, when issued, will be fully paid and non-assessable and will not be subject to any redemption or sinking fund provisions. Holders of common stock do not have any preemptive, subscription or conversion rights.

Holders of common stock are entitled to receive dividends declared by the Board of Directors out of legally available funds, subject to the rights of preferred shareholders, if any, and the terms of any existing or future agreements between us and our lenders. We presently intend to retain future earnings, if any, for use in the operation and expansion of our business. We do not anticipate paying cash dividends in the foreseeable future. See “Dividend Policy.” In the event of our liquidation, dissolution or winding up, common shareholders are entitled to share ratably in all assets legally available for distribution after payment of all debts and other liabilities, and subject to the prior rights of any holders of outstanding shares of preferred stock, if any.

Preferred Stock

Currently, we are authorized to issue 4,000,000 shares of Series A Preferred Stock, 7,000,000 shares of Series B Preferred Stock, 8,000,000 shares of Series C Preferred Stock and 20,000,000 shares of Series D Preferred Stock. As of March 31, 2007, there were 3,215,032 shares of Series A Preferred Stock held by 75 shareholders of record, 6,864,410 shares of Series B Preferred Stock held by 139 shareholders of record, 6,666,659 shares of Series C Preferred Stock held by 172 shareholders of record and 2,481,094 shares of Series D Preferred Stock held by 115 shareholders of record. Upon consummation of this offering, each share of Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock and Series D Preferred Stock will convert into one share of our common stock such that all of our outstanding preferred stock will convert into an aggregate of 19,227,195 shares of our common stock.

Upon the closing of this offering, the Board of Directors will be authorized to issue from time to time up to an aggregate of 5,000,000 shares of preferred stock in one or more series and to fix or alter the designations, preferences, rights and any qualifications, limitations or restrictions of the shares of each of these series, including the dividend rights, dividend rates, conversion rights, voting rights, term of redemption, including sinking fund provisions, redemption price or prices, liquidation preferences and the number of shares constituting any series or designations of a series without further vote or action by the shareholders. The issuance of preferred stock may have the effect of delaying, deferring or preventing a change in control of us without further action by the shareholders and may adversely affect the voting and other rights of the holders of common stock. The issuance of preferred stock with voting and conversion rights may adversely affect the voting power of the holders of common stock, including the loss of voting control. We currently have no plans to issue any shares of preferred stock.

 

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We believe that the ability to issue preferred stock without the expense and delay of a special shareholders’ meeting will provide us with increased flexibility in structuring possible future financings and acquisitions, and in meeting other corporate needs that might arise. This also permits the Board of Directors to issue preferred stock containing terms which could impede the completion of a takeover attempt, subject to limitations imposed by applicable securities laws. The Board of Directors will make any determination to issue these shares based on its judgment as to the best interests of NovaBay and our shareholders at the time of issuance. This could discourage an acquisition attempt or other transaction which shareholders might believe to be in their best interests or in which they might receive a premium for their stock over the then market price of the stock.

Anti-Takeover Provisions

California Law. We are subject to the provisions of Section 1203 of the California Corporations Code, which includes provisions that may have the effect of deterring hostile takeovers or delaying or preventing changes in control or management of NovaBay. First, if an “interested person” makes an offer to purchase the shares of some or all of our existing shareholders, we must obtain an affirmative opinion in writing as to the fairness of the offering price prior to completing the transaction. California law considers a person to be an “interested person” if the person directly or indirectly controls our company, if the person is directly or indirectly controlled by one of our officers or directors, or if the person is an entity in which one of our officers or directors holds a material financial interest. If after receiving an offer from such an “interested person”, we receive a subsequent offer from a neutral third party, then we must notify our shareholders of this offer and afford each of them the opportunity to withdraw their consent to the “interested person” offer. Section 1203 and other provisions of the California Corporations Code could make it more difficult for a third party to acquire a majority of our outstanding voting stock by discouraging a hostile bid, or delaying, preventing or deterring a merger, acquisition or tender offer in which our shareholders could receive a premium for their shares, or effect a proxy contest for control of NovaBay or other changes in our management.

We are also subject to other provisions of the California Corporations Code, which include voting requirements that may also have the effect of deterring hostile takeovers, disposing of our assets or delaying or preventing changes in control or management of NovaBay. Under Section 1101, if a single entity or constituent corporation owns more than 50% but less than 90% of the outstanding shares of any series of our capital stock and attempts to merge our Company into itself or other constituent corporation, the Company’s non-redeemable securities may only be exchanged for non-redeemable securities of the surviving entity unless all of our shareholders consent to the transaction or the terms of the transaction are approved and determined fair by the California Commissioner of Corporations. Likewise, Section 1001(d) of the California Corporations Code imposes similar restrictions on the disposition of the Company’s assets to affiliated entities. Under Section 1001(d), any proposed sale or disposition of all or substantially all of our assets to any other corporation that we are controlled by or under common control with must be consented to by our shareholders holding at least 90% of the outstanding shares of our capital stock or approved and determined fair by the California Commissioner of Corporations. Sections 1101 and 1001 could make it significantly more difficult for a third-party to acquire control of our Company by preventing a possible acquirer from cashing out minority shareholders or selling substantially all of our assets to a related party and therefore could discourage a hostile bid, or delay, prevent or deter entirely a merger, acquisition or tender offer in which our shareholders could receive a premium for their shares, or effect a proxy contest for control of NovaBay or other changes in our management.

Articles of Incorporation and Bylaws. Provisions of our amended and restated articles of incorporation and amended and restated bylaws may also make it more difficult to acquire control of us. These provisions could deprive shareholders of the opportunity to realize a premium on the shares of common stock owned by them. In addition, these provisions may adversely affect the prevailing market price of the stock and are intended to:

 

   

enhance the likelihood of continuity and stability in the composition of the Board and in the policies formulated by the Board;

 

   

discourage transactions which may involve an actual or threatened change in control of us;

 

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discourage tactics that may be used in proxy fights;

 

   

encourage persons seeking to acquire control of us to consult first with the Board of Directors to negotiate the terms of any proposed business combination or offer; and

 

   

reduce our vulnerability to an unsolicited proposal for a takeover that does not contemplate the acquisition of all of our outstanding shares or that is otherwise unfair to our shareholders.

Classified Board of Directors; Removal; Filling Vacancies and Amendment. Upon the closing of this offering, our amended and restated articles of incorporation and amended and restated bylaws will provide for the Board to be divided into three classes of directors serving staggered, three-year terms. The classification of the Board has the effect of requiring at least two annual shareholder meetings, instead of one, to replace a majority of the members of the Board. Subject to the rights of the holders of any outstanding series of preferred stock, the amended and restated bylaws will authorize the Board to fill vacancies, including newly created directorships and those resulting from removal by a vote of the shareholders. Accordingly, this provision could prevent a shareholder from obtaining majority representation on the Board by enlarging the Board of Directors and filling the new directorships with its own nominees.

Special Shareholder Meetings. Our amended and restated bylaws will provide that special meetings of shareholders for any purpose or purposes may only be called by the Chairman of the Board, the president, a majority of our Board or by shareholders holding in the aggregate no less than 10% of our common stock. Special meetings called by a shareholder shall be subject to certain advance notice and information content requirements. A special meeting of the shareholders may not be held absent a written request complying with these advance notice requirements and containing the specified informational content. The request shall state the purpose or purposes of the proposed meeting. This limitation on the right of shareholders to call a special meeting could make it more difficult for shareholders to initiate actions that are opposed by the Board of Directors. These actions could include the removal of an incumbent director or the election of a shareholder nominee as a director. They could also include the implementation of a rule requiring shareholder ratification of specific defensive strategies that have been adopted by the Board of Directors with respect to unsolicited takeover bids. In addition, the limited ability of the shareholders to call a special meeting of shareholders may make it more difficult to change the existing Board and management.

Written Consent; Special Meetings of Shareholders. The amended and restated articles of incorporation and amended and restated bylaws will prohibit the taking of shareholder action by written consent without a meeting unless such action has been previously approved by the Board of Directors. These provisions will make it more difficult for shareholders to take action opposed by the Board of Directors.

Amendment of Provisions in Our Amended and Restated Articles of Incorporation. Our amended and restated articles of incorporation will generally require the affirmative vote of the holders of at least two-thirds of the outstanding voting stock in order to amend any provisions of the articles of incorporation concerning:

 

   

the authority of shareholders to act by written consent; and

 

   

enlarging or reducing the authorized number of directors or fixing the exact number of directors.

These voting requirements will make it more difficult for minority shareholders to make changes in the articles of incorporation that could be designed to facilitate the exercise of control over us.

Amendment of Provisions in Our Amended and Restated Bylaws. Our amended and restated bylaws will generally require the affirmative vote of the holders of at least two-thirds of the outstanding voting stock in order to amend any provisions of the amended and restated bylaws concerning:

 

   

the removal or appointment of directors;

 

   

the authority of shareholders to act by written consent;

 

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procedure and content of shareholder proposals concerning business to be conducted at a meeting of shareholders;

 

   

director nominations by shareholders; and

 

   

enlarging or reducing the authorized number of directors or fixing the exact number of directors.

These voting requirements will make it more difficult for minority shareholders to make changes in the bylaws that could be designed to facilitate the exercise of control over us.

Options

As of March 31, 2007, options to purchase a total of 4,931,924 shares of common stock were outstanding, and up to 394,750 additional shares of common stock were reserved for future issuance under our 2005 Plan. For a more complete discussion of our stock option plans, please see “Management—Employee Benefit Plans.”

Registration Rights

No holders of our common stock are entitled to registration rights with respect to their shares. In connection with this offering, however, we have agreed to issue to the underwriters broker warrants to purchase an amount of our common stock equal to up to 7% of the number of shares sold pursuant to this offering (including the over-allotment option) at an exercise price equal to the public offering price of the shares sold in this offering. These warrants will have certain rights of registration in the United States of the common stock issuable upon exercise of the warrants, beginning one year from the date of this prospectus.

Transfer Agent and Registrar

Computershare Shareholder Services, Inc., located in Providence, Rhode Island, Providence County, is the transfer agent and registrar for our common stock in the United States and Computershare Investor Services, Inc., located in Toronto, Ontario, Canada, is the co-transfer agent and registrar for our common stock in Canada.

PRIOR SALES OF SHARES

The following table summarizes all issuances of shares of common stock by NovaBay during the 12 month period preceding the date of this prospectus.

 

Date of Issuance or Sale

 

Description of Transaction

 

Aggregate Number and

Type of Shares Issued

 

Price Per

Common Share

February 2007   Compensation for services rendered  

70,000 shares of

common stock

 

N/A

June 2006 to December 2006   Compensation for services rendered  

66,754 shares of

common stock

 

N/A

January 2006 to

June 2006

  Exercise of warrants   2,297,169 shares of common stock   $0.40 to $0.60
January 2006 to September 2006   Private placement   1,738,873 shares of Series D Preferred Stock (which will convert into 1,738,873 shares of common stock upon completion of this offering)   $1.50

 

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SHARES ELIGIBLE FOR FUTURE SALE

Prior to the offering, there has been no public market for our common stock, and there can be no assurance that a significant public market for our common stock will develop or be sustained after the offering. Any future sale of a substantial amount of our common stock in the public market after this offering, or the perception that such sales may occur, could adversely affect the prevailing market price of our common stock. Furthermore, because some of our shares will not be available for sale after this offering due to the contractual and legal restrictions on resale described below, the sale of a substantial amount of our common stock in the public market after these restrictions lapse could adversely affect the prevailing market price of our common stock and our ability to raise equity capital in the future.

U.S. Resale Restrictions

Upon completion of the offering, we will have              shares of common stock outstanding assuming no exercise of any options after March 31, 2007 and assuming no exercise of the underwriters’ over-allotment option or broker warrants. All of the shares sold by us in this offering will be freely tradable without restriction or further registration under the Securities Act of 1933, as amended (the “Securities Act”), except for shares held by persons who may be deemed our “affiliates,” as that term is defined under Rule 144 of the Securities Act.

In addition,              shares outstanding as of March 31, 2007, which shares were issued by us prior to                         , 2005, will be available for immediate sale in the U.S. public market as of the date of this prospectus. Following the expiration of, or release from, lock-up agreements with the representatives of the underwriters and the release from applicable escrow requirements,              additional shares will become available for sale in the public market 6 months after the closing of this offering, subject in some cases to compliance with the volume and other limitations of Rule 144. Thereafter,              additional shares held by our officers and directors will become eligible for sale in the public market over the subsequent three to 18 month period, as the shares are released from the lock-up agreements with the representatives of the underwriters and the release from applicable escrow requirements. Please see “Shares Eligible for Future Sale—Lock-Ups” below.

For the reasons set forth below, we expect that the following shares will be eligible for sale in the U.S. public market at the following times:

 

Date

  

Approximate

Number of Shares

Eligible for Sale in

U.S. Public Market

  

Comment

Upon effectiveness       Freely tradable shares sold in this offering; shares saleable under Rule 144(k)
3 months after the date of the prospectus       Shares released under lock-up agreements and applicable escrow requirements; shares saleable under Rule 144, 144(k) or 701
6 months after the date of the prospectus       Shares released under lock-up agreements and applicable escrow requirements; shares saleable under Rule 144, 144(k) or 701
9 months after the date of the prospectus       Shares released under lock-up agreements; shares saleable under Rule 144 or 701
12 months after the date of the prospectus       Shares released under lock-up agreements and applicable escrow requirements; shares saleable under Rule 144 or 701
18 months after the date of the prospectus       Shares released under lock-up agreements and applicable escrow requirements; shares saleable under Rule 144 or 701
24 months after the date of the prospectus       Shares released under lock-up agreements; shares saleable under Rule 144 or 701

 

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Rule 144

General

In general, under Rule 144 as currently in effect, a person, including an affiliate, who has beneficially owned our shares for at least one year is entitled to sell, within any three-month period commencing 90 days after the date of this prospectus, a number of such shares that does not exceed the greater of:

 

   

1% of the then outstanding shares of our common stock; or

 

   

the average weekly trading volume of our common stock during the four calendar weeks preceding such sale, subject to the filing of a Form 144 with the SEC by such person with respect to the sale.

Sales under Rule 144 are also subject to manner-of-sale provisions, notice requirements and the availability of current public information about us. However, these shares would remain subject to lock-up and escrow arrangements and would only become eligible for sale when the lock-up and escrow periods expire. Persons who are not our affiliates may be exempt from these restrictions under Rule 144(k) discussed below.

Rule 144(k)

A person who is not deemed to have been an affiliate of ours at any time during the 90 days immediately preceding the sale and who has beneficially owned his or her shares for at least two years is entitled to sell his or her shares under Rule 144(k) without regard to the limitations described above. Persons deemed to be affiliates must always sell under the limitations imposed by Rule 144, even after the applicable holding periods have been satisfied. However, if these shares are subject to lock-up or escrow arrangements, such shares would only become eligible for sale when the lock-up and escrow periods expire.

Rule 701

Any employee or consultant who purchased his or her shares under a written compensatory plan or contract is entitled to rely on the resale provisions of Rule 701, which permits non-affiliates to sell their Rule 701 shares without having to comply with the public information, holding period, volume limitation or notice provisions of Rule 144 and permits affiliates to sell their Rule 701 shares without having to comply with the Rule 144 holding period restrictions, in each case commencing 90 days after the date of this prospectus. As of December 31, 2006, the holders of options to purchase approximately              shares of common stock, which options were issued pursuant to Rule 701, will be eligible to sell their shares, upon exercise of such options and subject to the vesting thereof, upon the expiration of the 180-day lock-up period required by the stock option plan pursuant to which the options were granted.

Sale of Shares

We are unable to estimate the actual number of shares that will be sold pursuant to Rule 144 or Rule 701, since this will depend on the market price of our common stock, the personal circumstances of the sellers and other factors. Such future sales or the availability for sale of substantial amounts of our common stock in the public market could adversely affect prevailing market prices of our common stock and could impair our ability to raise capital through future sales of our securities.

We intend to file a registration statement on Form S-8 under the Securities Act as soon as practicable after the completion of the offering to register              shares of common stock subject to outstanding stock options or reserved for issuance under our stock plans. This registration will permit the resale of these shares by non-affiliates in the public market without restriction under the Securities Act, upon completion of the lock-up and escrow periods described above. Shares registered under the Form S-8 registration statement held by affiliates will be subject to Rule 144 volume limitations. See “Management—Compensation Discussion and Analysis” and “Management—Employee Benefit Plans.”

See also “Risk Factors—Future sales of shares by our shareholders could cause the market price of our common stock to drop significantly, even if our business is doing well”.

 

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Additional Canadian Resale Restrictions

Under the securities laws of the provinces of Canada in which shares of our common stock are being offered pursuant to this prospectus, a person who owns our common shares, or securities convertible into our common shares (other than options granted to our directors, officers, employees and consultants), issued by us more than four months prior to the date of this prospectus will generally be able to freely sell those common shares, or the common shares issued upon the conversion of such convertible securities, in Canada following the date of this prospectus. To the extent that such common shares or convertible securities were issued by us during the four months preceding the date of this prospectus, those common shares, or the common shares issued upon the conversion of those convertible securities, may not be resold, except under a prospectus or an exemption from the prospectus requirement, until four months have passed since the date of distribution of those securities by us, at which time such a person will generally be able to freely sell those common shares in Canada. Any of our directors, officers, employees and consultants who purchase common shares from us either directly or pursuant to the exercise of options granted at any time prior to the date of this prospectus will generally be able to freely resell those common shares in Canada following the date of this prospectus. Any sales of our common shares in Canada will be subject to the terms of applicable lock-up agreements. There are additional restrictions on the ability of “control block” holders of our common shares to dispose of the common shares they hold. A control block holder is any person, company or combination of persons or companies holding a sufficient number of our common shares to affect materially the control of us, and any person, company or combination holding more than 20 percent of our outstanding common shares will, in the absence of evidence to the contrary, be deemed to affect materially the control of us. Upon the closing of this offering, we do not expect that we will have any control block holders of our common shares.

Lock-Up Agreements

We have agreed not to issue, without the consent of the underwriters, during the period ending 180 days after the closing of this offering, any additional shares of our common stock or securities convertible or exchangeable into shares of our common stock, or rights to acquire any such securities. In addition, our President and Chief Executive Officer will enter into a lock-up agreement prior to the closing of the offering pursuant to which he will agree not to sell, transfer or otherwise assign or charge any of his securities of NovaBay except pursuant to the following schedule: (i) 15% after six months following the closing of this offering, (ii) 25% after 12 months following the closing of this offering, (iii) 30% after 18 months following the closing of this offering, and (iv) the remaining 30% after 24 months following the closing of this offering. Each of our other directors and officers will enter into lock-up agreements prior to the closing of the offering pursuant to which they will agree not to sell, transfer or otherwise assign or charge any of their securities of NovaBay except pursuant to the following schedule: (i) 50% after six months following the closing of this offering, (ii) 25% after nine months following the closing of this offering, and (iii) the remaining 25% after 12 months following the closing of this offering.

The foregoing lock-up periods will be extended if:

 

   

during the last 17 days of such lock-up period, we issue an earnings release or we disclose material news or a material event relating to our company occurs; or

 

   

prior to the expiration of such lock-up period, we announce that we will release earnings results during the 16-day period beginning on the last day of such lock-up period,

in which case the restrictions described in the preceding paragraph (and in each individual lock-up agreement) will continue to apply until the expiration of a 18-day period beginning on the issuance of the earnings release or the occurrence of the material news or material event.

 

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Canadian Escrow Requirements

Pursuant to applicable Canadian securities laws, certain of our officers, directors and shareholders may be required to comply with Canadian escrow provisions, whereby such parties would be required to deposit the following securities into escrow: our common stock held by such parties immediately prior to this offering; any securities held by such parties immediately prior to this offering that are convertible into or permit the holder to acquire our shares or other convertible securities, except for non-transferable incentive stock options to purchase our common stock solely for cash at a price equal to or greater than the offering price for our common stock under this offering; and, any of our common stock or convertible securities that are acquired by such parties in relation to securities that are in escrow at the time, including by way of dividend, other distribution, conversion or subdivision. Escrowed securities would be released from escrow in accordance with the following schedule: 25% of the escrowed securities may be initially released from escrow on the date of the listing of our common stock on the TSX (the “Initial Release”); 33% of the then remaining escrowed securities may be released from escrow six months after the Initial Release; 50% of the then remaining escrowed securities may be released from escrow twelve months after the Initial Release; and the remaining escrowed securities may be released from escrow eighteen months after the Initial Release. The escrowed securities may not be transferred or otherwise dealt with while held in escrow, except for certain specified exceptions permitted under the Canadian escrow provisions.

 

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MATERIAL U.S. FEDERAL INCOME AND ESTATE TAX

CONSIDERATIONS TO NON-U.S. HOLDERS

The following discussion is a summary of the material U.S. federal income tax considerations generally applicable to the purchase, ownership and disposition of our common stock by Non-U.S. Holders (as defined below). This summary deals only with our common stock held as capital assets by holders who purchase common stock in this offering. This discussion does not cover all aspects of U.S. federal income taxation that may be relevant to the purchase, ownership or disposition of our common stock by prospective investors in light of their particular circumstances. In particular, this discussion does not address all of the tax considerations that may be relevant to certain types of investors subject to special treatment under U.S. federal income tax laws, such as:

 

   

dealers in securities or currencies;

 

   

financial institutions;

 

   

regulated investment companies;

 

   

real estate investment trusts;

 

   

tax-exempt entities;

 

   

insurance companies;

 

   

persons that own or are deemed to own more than 5% of our common stock;

 

   

persons holding common stock as part of a hedging, integrated, conversion or constructive sale transaction or a straddle;

 

   

traders in securities that elect to use a mark-to-market method of accounting for their securities holdings;

 

   

persons liable for alternative minimum tax;

 

   

U.S. expatriates;

 

   

partnerships or entities or arrangements treated as a partnership or other pass-through entity for U.S. federal tax purposes (or investors therein); or

 

   

U.S. Holders (as defined below).

Furthermore, this summary is based upon the provisions of the Internal Revenue Code, the Treasury regulations promulgated thereunder and administrative and judicial interpretations thereof, all as of the date hereof. Such authorities may be repealed, revoked, modified or subject to differing interpretations, possibly on a retroactive basis, so as to result in U.S. federal income tax consequences materially different from those discussed below. We have not received a ruling from the Internal Revenue Service, or the IRS, with respect to any of the matters discussed herein, and therefore there can be no assurance that the IRS would agree with the conclusions stated herein. This discussion does not address any state, local or non-U.S. tax considerations.

For purposes of this summary, a “Non-U.S. Holder” is a beneficial owner of our common stock (other than a partnership or an entity or arrangement treated as a partnership for U.S. federal income tax purposes) that is not a U.S. Holder. A “U.S. Holder” means a beneficial owner of our common stock that is for U.S. federal income tax purposes one of the following:

 

   

a citizen or an individual resident of the United States;

 

   

a corporation (or other entity taxable as a corporation) created or organized in or under the laws of the United States or any state thereof or the District of Columbia;

 

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an estate, the income of which is subject to U.S. federal income taxation regardless of its source; or

 

   

a trust if it (i) is subject to the primary supervision of a court within the United States and one or more U.S. persons have the authority to control all substantial decisions of the trust, or (ii) has a valid election in effect under applicable U.S. Treasury regulations to be treated as a U.S. person.

If a partnership or other entity or arrangement treated as a partnership for U.S. federal income tax purposes holds our common stock, the U.S. federal income tax treatment of a partner in such partnership will generally depend upon the status of the partner and the activities of the partnership. If you are a partnership or a partner of a partnership holding our common stock, we particularly urge you to consult your own tax advisors.

Special rules may apply to you if you are a “controlled foreign corporation” or a “passive foreign investment company”, or are otherwise subject to special treatment under the Internal Revenue Code. Any such holders should consult their own tax advisors to determine the U.S. federal, state, local and non-U.S. income and other tax consequences that may be relevant to them.

If you are considering the purchase of our common stock, we urge you to consult your own tax advisors concerning the particular U.S. federal income tax consequences to you of the purchase, ownership and disposition of our common stock, as well as any consequences to you arising under state, local and non-U.S. tax laws.

Dividends

Dividends paid to you (to the extent paid out of our current or accumulated earnings and profits, as determined for U.S. federal income tax purposes) generally will be subject to U.S. federal withholding tax at a 30% rate, or such lower rate as may be specified by an applicable tax treaty. However, dividends that are effectively connected with a trade or business you conduct within the United States, or, if certain tax treaties apply to you, are attributable to a permanent establishment you maintain in the United States, are not subject to the U.S. federal withholding tax, but instead are subject to U.S. federal income tax on a net income basis at the applicable graduated individual or corporate rates. Special certification and disclosure requirements must be satisfied for effectively connected income to be exempt from withholding. If you are a corporation, any such effectively connected dividends that you receive may be subject to an additional branch profits tax at a 30% rate or such lower rate as may be specified by an applicable income tax treaty.

If you wish to claim the benefit of an applicable treaty rate for dividends paid on our common stock, you must provide the withholding agent with a properly executed IRS Form W-8BEN, claiming an exemption from or reduction in withholding under the applicable income tax treaty. In the case of common stock held by a foreign intermediary (other than a “qualified intermediary”), the intermediary generally must provide an IRS Form W-8IMY and attach thereto an appropriate certification by each beneficial owner for which it is receiving the dividends.

If you are eligible for a reduced rate of U.S. federal withholding tax pursuant to an applicable income tax treaty, you may obtain a refund of any excess amounts withheld by filing an appropriate claim for refund with the IRS.

Sale, Exchange or Other Taxable Disposition of Common Stock

You generally will not be subject to U.S. federal income tax with respect to gain recognized on a sale, exchange or other taxable disposition of shares of our common stock unless:

 

   

the gain is effectively connected with your conduct of a trade or business in the United States, or, if certain tax treaties apply, is attributable to a permanent establishment you maintain in the United States; or

 

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if you are an individual and hold shares of our common stock as a capital asset, you are present in the United States for 183 or more days in the taxable year of the sale, exchange or other taxable disposition, and you have a “tax home” in the United States.

If you are an individual and are described in the first bullet above, you will be subject to tax on any gain derived from the sale, exchange or other taxable disposition at applicable graduated U.S. federal income tax rates. If you are an individual and are described in the second bullet above, you will generally be subject to a flat 30% tax on any gain derived from the sale, exchange or other taxable disposition that may be offset by U.S. source capital losses (even though you are not considered a resident of the United States). If you are a corporation and are described in the first bullet above, you will be subject to tax on your gain at applicable graduated U.S. federal income tax rates and, in addition, may be subject to the branch profits tax on your effectively connected earnings and profits for the taxable year, which would include such gain, at a rate of 30% or at such lower rate as may be specified by an applicable income tax treaty, subject to adjustments.

U.S. Federal Estate Tax

Shares of our common stock held by an individual Non-U.S. Holder at the time of his or her death will be included in such Non-U.S. Holder’s gross estate for U.S. federal estate tax purposes, unless an applicable estate tax treaty provides otherwise.

Information Reporting and Backup Withholding

 

   

You may be subject to information reporting and backup withholding with respect to any dividends on, and the proceeds from dispositions of, our common stock paid to you, unless you comply with certain reporting procedures (usually satisfied by providing an IRS Form W-8BEN) or otherwise establish an exemption. Additional rules relating to information reporting requirements and backup withholding with respect to the payment of proceeds from the disposition of shares of our common stock will apply as follows:If the proceeds are paid to or through the U.S. office of a broker (U.S. or foreign), they generally will be subject to backup withholding and information reporting, unless you certify that you are not a U.S. person under penalties of perjury (usually on an IRS Form W-8BEN) or otherwise establish an exemption;

 

   

If the proceeds are paid to or through a non-U.S. office of a broker that is not a U.S. person and is not a foreign person with certain specified U.S. connections, or a U.S. Related Person, they will not be subject to backup withholding or information reporting; and

 

   

If the proceeds are paid to or through a non-U.S. office of a broker that is a U.S. person or a U.S. Related Person, they generally will be subject to information reporting (but not backup withholding), unless you certify that you are not a U.S. person under penalties of perjury (usually on an IRS Form W-8BEN) or otherwise establish an exemption.

 

   

In addition, the amount of any dividends paid to you and the amount of tax, if any, withheld from such payment generally must be reported annually to you and the IRS. The IRS may make such information available under the provisions of an applicable income tax treaty to the tax authorities in the country in which you reside.

Any amounts withheld under the backup withholding rules will be allowed as a refund or a credit against your U.S. federal income tax liability provided the required information is timely furnished by you to the IRS. Non-U.S. Holders should consult their own tax advisors regarding the filing of a U.S. tax return for claiming a refund of such backup withholding.

 

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MATERIAL CANADIAN FEDERAL INCOME TAX CONSIDERATIONS

The following is, as of the date hereof, a summary of the principal Canadian federal income tax considerations generally applicable to a purchaser who purchases common stock pursuant to the offering. This summary applies only to a purchaser who, for purposes of the Income Tax Act (Canada) (“Tax Act”), and at all relevant times, is or is deemed to be resident in Canada, deals at arm’s length with and is not affiliated with NovaBay and holds common stock as capital property (a “Holder”). The common stock will generally constitute capital property to a holder thereof unless the holder holds the shares in the course of carrying on a business of buying and selling securities or acquires the shares in a transaction or transactions considered to be an adventure in the nature of trade.

This summary is based on the current provisions of the Tax Act and the regulations thereunder, (“Regulations”), all proposals to amend the Tax Act and the Regulations publicly announced by or on behalf of the Minister of Finance (Canada) prior to the date hereof (the “Proposed Amendments”), and our counsel’s understanding of the current published administrative policies and practices of the Canada Revenue Agency (“CRA”) made publicly available prior to the date hereof. Except for the Proposed Amendments, this summary does not take into account or anticipate any changes in law or in administrative policies or assessing practices, nor does it take into account provincial or territorial tax laws of Canada or the tax laws of any foreign jurisdiction. No assurance can be given that the Proposed Amendments will be enacted as proposed (or at all) or that legislative, judicial or administrative changes will not alter the statements made herein.

This summary does not apply to a Holder (i) that is either a “specified financial institution” as defined in the Tax Act or a “financial institution” within the meaning of the Tax Act for purposes of the mark-to-market rules; (ii) an interest in which constitutes a “tax shelter investment” within the meaning of the Tax Act; or (iii) with respect to whom NovaBay is a “foreign affiliate” within the meaning of the Tax Act. The federal income tax consequences to a particular purchaser of an investment in our common stock will vary according to a number of factors including the legal status of the purchaser as an individual, a trust, a corporation or a partnership, and the province or provinces in which the purchaser resides, carries on business or has a permanent establishment.

This summary is of a general nature only and is not intended to be, nor should it be construed to be, legal or tax advice to any particular purchaser. Accordingly, each potential purchaser should obtain independent advice regarding the income tax consequences of investing in the common stock with reference to the purchaser’s own particular circumstances.

For the purposes of the Tax Act, all amounts relating to the acquisition, holding or disposition of our common stock, including dividends, adjusted cost base and proceeds of disposition, must be converted into Canadian dollars using the Canadian/U.S. dollar exchange rate prevailing at the time such amounts arise.

Disposition of Shares

A Holder of our common stock will realize a capital gain (or capital loss) on a disposition, or a deemed disposition of such common stock equal to the amount by which the proceeds of disposition of the common stock, net of any reasonable costs of disposition, exceed (or are less than) the adjusted cost base of the common stock to the Holder. The cost of any common stock acquired pursuant to the offering must be averaged with the adjusted cost base of all other shares of our common stock that are held by the Holder as capital property.

One-half of any such capital gain (a taxable capital gain) must be included in computing the income of the holder in the year of disposition, and one-half of any such capital loss (an allowable capital loss) generally must be deducted against taxable capital gains realized by the holder in the year of disposition. Allowable capital losses in excess of taxable capital gains for the year of disposition generally may be deducted by the holder against net taxable capital gains realized in any of the three preceding years or in any subsequent year, subject to the detailed provisions of the Tax Act.

 

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A Holder that is, throughout the relevant taxation year, a “Canadian-controlled private corporation” as defined in the Tax Act may be liable to pay, in addition to the tax otherwise payable under the Tax Act, a refundable tax of 6  2 / 3 % of its “aggregate investment income” for the year which is defined to include taxable capital gains.

Capital gains realized by an individual (including certain trusts) may give rise to a liability for alternative minimum tax as calculated under the detailed rules set out in the Tax Act.

Dividends

Dividends received or deemed to be received on our common stock will be included in the Holder’s income for the purposes of the Tax Act. Such dividends received by a Holder who is an individual will not be subject to the gross-up and dividend tax credit rules in the Tax Act. A Holder that is a corporation will not be entitled to deduct the amount of such dividends in computing its taxable income. A Holder that is throughout the relevant taxation year a “Canadian-controlled private corporation”, as defined in the Tax Act, may be liable to pay an additional refundable tax of 6  2 / 3 % on its “aggregate investment income” for the year, which will include such dividends. Subject to the detailed rules in the Tax Act, a Holder may be entitled to a foreign tax credit or deduction for any U.S. withholding tax paid with respect to dividends that the Holder receives on our common stock.

Foreign Property Information Reporting

A Holder who is a “specified Canadian entity” for a taxation year or a fiscal period and whose total cost amount of “specified foreign property”, including our common stock at any time in the year or fiscal period exceeds Cdn$100,000 will be required to file an information return for the year or period disclosing prescribed information in respect of such property. Subject to certain exceptions, a taxpayer resident in Canada in the year will be a “specified Canadian entity.” Holders are encouraged to consult their own tax advisors as to whether they must file an information return under these rules.

Foreign Investment Entity Status

Bill C-33 contains revised draft legislation relating to the income tax treatment of investments by Canadian residents in non-resident entities that constitute “foreign investment entities” (“FIEs”) applicable for taxation years commencing after 2006 (the “FIE Tax Proposals”). The FIE Tax Proposals, as currently drafted, would apply to require a Holder that holds a “participating interest” (that is not an “exempt interest”) in a non-resident entity that is an FIE at the entity’s taxation year-end to take into account in computing the Holder’s income for the Holder’s taxation year that includes such taxation year-end: (i) an amount based on a prescribed rate of return on the “designated cost” of such participating interest held by the Holder at the end of each month ending in the Holder’s taxation year at which time the participating interest is held by the Holder; or (ii) in certain limited circumstances, and only where the Holder elects such treatment, any gains and losses accrued on such participating interest for the year under a “mark-to-market” rule.

For the purposes of the FIE Tax Proposals, shares of our common stock will constitute “participating interests” in NovaBay. However, NovaBay will not be an FIE at a particular time if either (a) at the end of the taxation year that includes that time, the “carrying value” of all of our “investment property” is not greater than one-half of the “carrying value” of all of our property, or (b) throughout the taxation year that includes that time, our principal undertaking was the carrying on of a business that is not an “investment business.” The determination of whether or not NovaBay is an FIE must be made on an annual basis at the end of each taxation year of NovaBay.

Even if NovaBay were an FIE, a share of common stock will be an “exempt interest” provided that at all relevant times: (i) NovaBay is resident in the United States; (ii) our common stock is listed on a “prescribed stock exchange” (which currently includes the TSX and the AMEX); (iii) our common stock constitutes an “arm’s length interest” (as defined for the purposes of the FIE Tax Proposals), and (iv) it is reasonable to conclude that the Holder has no “tax avoidance motive” in respect of such share.

 

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We believe that a share of our common stock will constitute an “arm’s length interest” of a particular Holder for this purpose provided such Holder (together with entities and individuals with whom the Holder does not deal at arm’s length for purposes of the Tax Act) does not hold, in the aggregate, more than 10% of all or our issued and outstanding common stock.

For purposes of determining whether a share of our common stock is an arm’s length interest, a Holder generally will be regarded as having a tax avoidance motive only if it is reasonable to conclude that the main reasons for acquiring or holding such share include directly or indirectly benefiting principally from income, profits, gains or increases in value in respect of investment property (as defined for this purpose) and from the deferral or reduction of tax that would have been payable on such income, profits or gains. The determination of whether common stock constitutes an exempt interest to a particular Holder must be made on an annual basis at the end of the taxation year of NovaBay and no assurances can be given that the common stock will constitute an exempt interest at any particular time.

Holders should consult their own tax advisors about the application of the FIE Tax Proposals having regard to their particular circumstances.

 

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UNDERWRITING

General

We intend to enter into an underwriting agreement with the underwriters named below (collectively, the “Underwriters”). Dundee Securities Corporation,              and              are acting as representatives of the Underwriters. Subject to the terms and conditions in the underwriting agreement, we have agreed to issue and sell and each Underwriter named below has agreed, severally, to purchase from us upon the closing of this offering, on a firm commitment basis, the respective number of shares of common stock shown opposite its name below:

 

Underwriter

   Number of
Shares

Dundee Securities Corporation

  
  
  
    

Total

  
    

The obligations of the Underwriters under the underwriting agreement are conditional and may be terminated at their discretion on the basis of their assessment of the state of the financial markets and may also be terminated upon the occurrence of certain stated events. The Underwriters are, however, severally obligated to take up and pay for all shares of our common stock they have obligated themselves to purchase if any of the shares are purchased under the underwriting agreement. However, the Underwriters are not required to take or pay for the shares covered by the over-allotment option described below.

The offering is being made concurrently in the United States and in British Columbia, Alberta, Manitoba and Ontario, Canada. The shares of our common stock will be offered in the United States through those Underwriters or their United States affiliates who are registered to offer the shares for sale in the United States and such other registered dealers as may be designated by the Underwriters. The shares of our common stock will be offered in the relevant provinces of Canada through those Underwriters or their Canadian affiliates who are registered to offer the shares for sale in such provinces and such other registered dealers as may be designated by the Underwriters. Subject to applicable law, the Underwriters may offer the shares outside of the United States and Canada.

Over-Allotment Option

We have granted to the Underwriters an option to purchase up to an aggregate of              shares of our common stock, exercisable solely to cover over-allotments, if any, at the public offering price less the underwriting discounts and commissions shown on the cover page of this prospectus. The Underwriters may exercise this option in whole or in part at any time until 30 days after the closing of this offering. To the extent the Underwriters exercise this option, each Underwriter will be committed, so long as the conditions of the underwriting agreement are satisfied, to purchase a number of shares from us proportionate to that Underwriter’s initial commitment as indicated in the preceding table. We will be obligated to issue and sell the shares to the Underwriters to the extent the option is exercised. This prospectus also qualifies the grant of this option and the distribution of the common shares transferable upon the exercise of this option.

Commissions and Expenses

The Underwriters have advised us that they propose to offer the common stock directly to the public at the public offering price presented on the cover page of this prospectus, and to selected dealers, who may include the Underwriters, at the public offering price less a selling concession not in excess of $             per share. The Underwriters may allow, and the selected dealers may reallow, a concession not in excess of $             per share to brokers and dealers. If all the shares are not sold at the initial public offering price, the Underwriters may decrease and thereafter further change, from time to time, the public offering price to an amount not greater than

 

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the initial public offering price and may change other selling terms, and the compensation realized by the Underwriters will be decreased by the amount that the aggregate price paid by purchasers for the shares is less than the gross proceeds paid by the Underwriters to us. The public offering price for the shares offered in the United States is payable in U.S. dollars and the public offering price for the shares offered in Canada is payable in Canadian dollars. The Canadian dollar amount is the equivalent of the U.S. price of the shares based on the prevailing U.S.-Canadian dollar exchange rate on the date of the underwriting agreement.

The following table summarizes the underwriting discounts and commissions that we will pay to the Underwriters in connection with this offering. These amounts are shown assuming both no exercise and full exercise of the Underwriters’ option to purchase additional shares of common stock.

 

     No Exercise    Full Exercise

Discounts and commissions per share

   $                 $             

Total discounts and commissions paid by us

   $                 $             

Discounts and commissions on the sale of shares to certain investors identified by us will be 0.7% rather than 7%, and to the extent such investors purchase shares in this offering the aggregate underwriting discounts and commissions will be reduced accordingly.

We have also agreed to grant to the Underwriters broker warrants that include the option to purchase an amount of our common stock equal to up to 7% of the number of shares sold pursuant to this offering (including the over-allotment option) at the offering price of the shares. The warrants are not exercisable until one year after the closing of this offering. These warrants are not assignable and will expire 3 years after the closing of this offering, subject to regulatory approval. The warrants have certain rights of registration in the United States of the common stock issuable upon exercise of the warrants.

In connection with the execution of an engagement letter with Dundee Securities Corporation (“Dundee”) related to this offering, we paid a non-refundable work fee to Dundee in the amount of $10,000. Upon the successful completion of this offering, the work fee will be credited to us by Dundee against the Underwriters’ commission; and conditioned on the successful completion of this offering, we granted to Dundee for the term of the engagement letter, and for the twelve month period following the term, a right of first refusal to participate as financial advisor and capital markets advisor, co-manager, co-placement agent or co-arranger, as the case may be, for any public offering or private placement of our equity, equity-linked or debt (including, without limitation, asset-backed) securities or mezzanine financing. The term of the engagement letter will terminate on the earlier of (a) June 30, 2007, (b) the execution of an underwriting agreement related to this offering, and (c) the termination of the engagement letter by either us or Dundee upon thirty days’ prior written notice.

We estimate that the total expenses of the offering, including prospectus, registration, filing and listing fees, printing fees and legal and accounting expenses, but excluding underwriting discounts and commissions, will be approximately $            .

Lock-Up Agreements

We have agreed not to issue, without the consent of the Underwriters, during the period ending 180 days after the closing of this offering, any additional shares of our common stock or securities convertible or exchangeable into shares of our common stock, or rights to acquire any such securities. In addition, our President and Chief Executive Officer will enter into a lock-up agreement prior to the closing of the offering pursuant to which he will agree not to sell, transfer or otherwise assign or charge any of his securities of NovaBay except pursuant to the following schedule: (i) 15% after six months following the closing of this offering, (ii) 25% after 12 months following the closing of this offering, (iii) 30% after 18 months following the closing of this offering, and (iv) the remaining 30% after 24 months following the closing of this offering. Each of our other directors and officers will enter into lock-up agreements prior to the closing of the offering pursuant to which they will agree

 

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not to sell, transfer or otherwise assign or charge any of their securities of NovaBay except pursuant to the following schedule: (i) 50% after six months following the closing of this offering, (ii) 25% after nine months following the closing of this offering, and (iii) the remaining 25% after 12 months following the closing of this offering.

Offering Price Determination

Prior to this offering, there has been no public market for our common stock. The initial public offering price has been negotiated between the representatives and us. Among the factors to be considered in determining the initial public offering price of our common stock will be the following:

 

   

prevailing market conditions;

 

   

our historical performance and capital structure;

 

   

estimates of our business potential and earnings prospects;

 

   

an overall assessment of our management; and

 

   

the consideration of these factors in relation to market valuation of companies in related businesses.

Listing on Stock Exchange

We have applied to list our shares on the AMEX and on the TSX under the symbol “NBY.” Any such listing will be subject to the approval of the relevant stock exchange, and any such approval would not be given unless all of the original listing requirements were met.

Indemnification and Contribution

We have agreed to indemnify the Underwriters against certain liabilities relating to the offering, including liabilities under the Securities Act and applicable securities laws in Canada, and to contribute to payments that the Underwriters may be required to make for these liabilities. If we are unable to provide this indemnification, we will contribute to payments the Underwriters and their controlling persons may be required to make in respect of those liabilities.

Stabilization, Short Positions and Penalty Bids

The representatives may engage in over-allotment, stabilizing transactions, syndicate covering transactions and penalty bids or purchases for the purpose of pegging, fixing or maintaining the price of the common stock, in accordance with Regulation M under the U.S. Securities Exchange Act of 1934, as amended.

In addition, in accordance with rules and policy statements of certain Canadian provincial securities commissions, an Underwriter may not, throughout the period of distribution, bid for or purchase our common shares for its own account or the account of a person over which it exercises direction and control. Exceptions, however, exist where the bid or purchase is not made for the purpose of creating actual or apparent active trading in, or raising prices of, the common shares. These exceptions include a bid or purchase permitted under the by-laws and rules of applicable regulatory authorities, the Universal Market Integrity Rules for Canadian Marketplaces administered by Market Regulation Services Inc., the TSX and AMEX relating to market stabilization and passive market making activities and a bid or purchase made for and on behalf of a customer where the order was not solicited during the period of distribution.

Over-allotment transactions involve sales by the Underwriters of shares in excess of the number of shares the Underwriters are obligated to purchase, which creates a syndicate short position. The short position may be either a covered short position or a naked short position. In a covered short position, the number of shares over-

 

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allotted by the Underwriters is not greater than the number of shares that they may purchase in the over-allotment option. In a naked short position, the number of shares involved is greater than the number of shares in the over-allotment option. The Underwriters may close out any short position by either exercising their over-allotment option and/or purchasing shares in the open market.

Stabilizing transactions permit bids to purchase the underlying security so long as the stabilizing bids do not exceed a specific maximum.

Syndicate covering transactions involve purchases of our common stock in the open market after the distribution has been completed in order to cover syndicate short positions. In determining the source of shares to close out the short position, the Underwriters will consider, among other things, the price of shares available for purchase in the open market as compared to the price at which they may purchase shares through the over-allotment option. If the Underwriters sell more shares than could be covered by the over-allotment option, a naked short position, the position can only be closed out by buying shares in the open market. A naked short position is more likely to be created if the Underwriters are concerned that there could be downward pressure on the price of the shares in the open market after pricing that could adversely affect investors who purchase in the offering.

Penalty bids permit the representatives to reclaim a selling concession from a syndicate member when the common stock originally sold by the syndicate member is purchased in a stabilizing or syndicate covering transaction to cover syndicate short positions.

These stabilizing transactions, syndicate covering transactions and penalty bids may have the effect of raising or maintaining the market price of our common stock or preventing or retarding a decline in the market price of our common stock. As a result, the price of our common stock may be higher than the price that might otherwise exist in the open market. These transactions may be effected on the TSX, AMEX or otherwise and, if commenced, may be discontinued at any time.

Neither we nor any of the Underwriters make any representation or prediction as to the direction or magnitude of any effect that the transactions described above may have on the price of our common stock. In addition, neither we nor any of the Underwriters make any representation that the representatives will engage in these stabilizing transactions or that any transaction, once commenced, will not be discontinued without notice.

Directed Share Program

At our request, the Underwriters have reserved up to              shares, or      % of the shares offered by this prospectus, for sale under a directed share program to our officers, directors, employees and related parties, immediate family members and entities of which employees or family members are the sole beneficiaries. All of the persons purchasing such reserved shares must commit to purchase them upon the date of this prospectus but no later than the close of business on the day following that date. The number of shares available for sale to the general public will be reduced to the extent these persons purchase the reserved shares. Shares committed to be purchased by directed share program participants which are not so purchased will be reallocated for sale to the general public in this offering. All sales of shares pursuant to the directed share program will be made at the initial public offering price set forth on the cover page of this prospectus.

Affiliations

The Underwriters and their affiliates may provide certain commercial banking, financial advisory and investment banking services for us for which they receive fees. The Underwriters and their affiliates may from time to time in the future engage in transactions with us and perform services for us in the ordinary course of their business.

 

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NOTICE TO INVESTORS

European Economic Area

With respect to each Member State of the European Economic Area which has implemented Prospectus Directive 2003/71/EC, including any applicable implementing measures, from and including the date on which the Prospectus Directive is implemented in that Member State, the offering of our shares in this offering is only being made:

 

   

to legal entities which are authorized or regulated to operate in the financial markets or, if not so authorized or regulated, whose corporate purpose is solely to invest in securities;

 

   

to any legal entity which has two or more of (i) an average of at least 250 employees during the last financial year; (ii) a total balance sheet of more than €443,000,000 and (iii) an annual net turnover of more than €450,000,000, as shown in its last annual or consolidated accounts; or

 

   

in any other circumstances which do not require the publication by the issuer of a prospectus pursuant to Article 3 of the Prospectus Directive.

United Kingdom

Our shares may not be offered or sold and will not be offered or sold to any persons in the United Kingdom other than to persons whose ordinary activities involve them in acquiring, holding, managing or disposing of investments (as principal or as agent) for the purposes of their businesses and in compliance with all applicable provisions of the Financial Services and Markets Act 2000 (FSMA) with respect to anything done in relation to our shares in, from or otherwise involving the United Kingdom. In addition, any invitation or inducement to engage in investment activity (within the meaning of Section 21 of the FSMA) in connection with the issue or sale of our shares may only be communicated in circumstances in which Section 21(1) of the FSMA does not apply to us. Without limitation to the other restrictions referred to herein, this offering circular is directed only at (1) persons outside the United Kingdom; (2) persons having professional experience in matters relating to investments who fall within the definition of “investment professionals” in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005; or (3) high net worth bodies corporate, unincorporated associations and partnerships and trustees of high value trusts as described in Article 49(2) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005. Without limitation to the other restrictions referred to herein, any investment or investment activity to which this offering circular relates is available only to, and will be engaged in only with, such persons, and persons within the United Kingdom who receive this communication (other than persons who fall within (2) or (3) above) should not rely or act upon this communication.

Switzerland

Our shares may be offered in Switzerland only on the basis of a non-public offering. This prospectus does not constitute an issuance prospectus according to articles 652a or 1156 of the Swiss Federal Code of Obligations or a listing prospectus according to article 32 of the Listing Rules of the Swiss exchange. Our shares may not be offered or distributed on a professional basis in or from Switzerland and neither this prospectus nor any other offering material relating to our shares may be publicly issued in connection with any such offer or distribution. The shares have not been and will not be approved by any Swiss regulatory authority. In particular, the shares are not and will not be registered with or supervised by the Swiss Federal Banking Commission, and investors may not claim protection under the Swiss Investment Fund Act.

 

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LEGAL MATTERS

The validity of the issuance of the shares of common stock offered by this prospectus will be passed upon for us by Dorsey & Whitney LLP, as to matters of U.S. law, and Fasken Martineau DuMoulin LLP, as to matters of Canadian law. Legal matters relating to the sale of common stock in this offering will be passed upon for the underwriters by Skadden, Arps, Slate, Meagher & Flom LLP, as to matters of U.S. law, and Blake, Cassels & Graydon LLP, as to matters of Canadian law.

EXPERTS

The financial statements as of December 31, 2006 and 2005 and for each of the years in the three year period ended December 31, 2006 included in this prospectus have been audited by Davidson & Company LLP, independent registered public accountants, as indicated in their reports with respect thereto, and are included herein in reliance upon the authority of said firm as experts in auditing and accounting in giving said reports. The offices of Davidson & Company LLP are located at 1200-609 Granville Street, P.O. Box 10372, Pacific Centre, Vancouver, B.C. V7Y 1G6.

 

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WHERE YOU CAN FIND MORE INFORMATION

We have filed a registration statement on Form S-1 with the SEC under the Securities Act with respect to the common stock offered by this prospectus. This prospectus, which constitutes a part of the registration statement, does not contain all of the information set forth in the registration statement or the exhibits and schedules filed therewith. For further information with respect to us and our common stock, please see the registration statement and the exhibits and schedules filed with the registration statement.

Statements contained in this prospectus regarding the contents of any contract or any other document that is filed as an exhibit to the registration statement are not necessarily complete, and each such statement is qualified in all respects by reference to the full text of such contract or other document filed as an exhibit to the registration statement. The registration statement, including its exhibits and schedules, may be inspected without charge at the public reference room maintained by the SEC, located at 100 F Street, N.E., Room 1580, Washington, D.C. 20549, and copies of all or any part of the registration statement may be obtained from such offices upon the payment of the fees prescribed by the SEC. Please call the SEC at 1-800-SEC-0330 for further information about the public reference room. The SEC also maintains an Internet website that contains reports, proxy and information statements and other information regarding registrants that file electronically with the SEC. The address of the site is www.sec.gov. We will also be subject to the informational requirements of the securities commissions in all provinces of Canada. In this respect, we intend to file certain reports, statements or other information with the Canadian provincial securities commissions. These filings, other than confidential filings, are electronically available from the Canadian System for Electronic Document Analysis and Retrieval (SEDAR) ( http://www.sedar.com ), the Canadian equivalent of the SEC’s electronic document gathering and retrieval system.

Upon completion of this offering, we will become subject to the information and periodic reporting requirements of the Exchange Act, and, in accordance therewith, will file periodic reports, proxy statements and other information with the SEC. Such periodic reports, proxy statements and other information will be available for inspection and copying at the public reference room and on the SEC website referred to above.

Upon the filing of a final prospectus with the securities regulatory authorities in the provinces of Canada in which shares of our common stock are being offered pursuant hereto, we will become a reporting issuer under the securities laws of those jurisdictions that provide for a reporting issuer regime. Pursuant to the rules of the securities regulatory authorities of such jurisdictions, we are generally exempt from the requirements of the laws of such jurisdictions relating to continuous disclosure and proxy solicitation. Our insiders may also, in certain circumstances, be exempt from Canadian insider reporting requirements. These rules generally permit us to comply with certain informational requirements applicable in the U.S. instead of the continuous disclosure requirements normally applicable in such Canadian jurisdictions, provided that the relevant documents are filed with the securities regulatory authorities in the relevant Canadian jurisdictions and are provided to security holders in Canada to the extent and in the manner and within the time required by applicable U.S. requirements. These filings will be electronically available from the Canadian System for Electronic Document Analysis and Retrieval (SEDAR) ( http://www.sedar.com ).

 

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INDEX TO FINANCIAL STATEMENTS

 

Report of Independent Registered Public Accounting Firm

   F-2

Balance Sheets as of December 31, 2005 and 2006 and March 31, 2007

   F-3

Statements of Operations for the Years Ended December 31, 2004, 2005 and 2006 and for the Three Months Ended March 31, 2006 and 2007 and for the Cumulative Period from July 1, 2002 (date of development stage inception) to March 31, 2007

   F-4

Statements of Stockholders’ Equity as of December 31, 2002, 2003, 2004, 2005 and 2006 and March 31, 2007

   F-5

Statements of Cash Flows for the Years Ended December 31, 2004, 2005 and 2006 and for the Three Months Ended March 31, 2006 and 2007 and for the Cumulative Period from July 1, 2002 (date of development stage inception) to March 31, 2007

   F-7

Notes to Financial Statements

   F-8

 

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and the Stockholders of

NovaBay Pharmaceuticals, Inc.

(formerly NovaCal Pharmaceuticals, Inc.)

We have audited the accompanying balance sheets of NovaBay Pharmaceuticals, Inc. (formerly NovaCal Pharmaceuticals, Inc.) (a development stage company) as at December 31, 2006 and 2005 and the related statements of operations, cash flows and stockholders’ equity for the years ended December 31, 2006, 2005 and 2004. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of the Company as at December 31, 2006 and 2005 and the results of its operations and its cash flows for the years ended December 31, 2006, 2005 and 2004 in conformity with generally accepted accounting principles in the United States of America.

/s/ Davidson & Company LLP

Chartered Accountants

Vancouver, Canada

February 15, 2007 (except as to Note 13

which is as of May 29, 2007)

 

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NOVABAY PHARMACEUTICALS, INC.

(formerly NovaCal Pharmaceuticals, Inc.)

(a development stage company)

BALANCE SHEETS

(in thousands, except per share data)

 

     December 31,     March 31,
2007
    Pro Forma
Stockholders’
Equity at
March 31,
2007
 
     2005     2006      
                 (unaudited)     (unaudited)  

ASSETS

        

Current assets:

        

Cash and cash equivalents

   $ 2,208     $ 4,903     $ 3,861    

Short-term investments

     1,004       6,183       6,192    

Prepaid expenses and other current assets

     83       226       507    
                          

Total current assets

     3,295       11,312       10,560    

Property and equipment, net

     267       554       923    
                          

TOTAL ASSETS

   $ 3,562     $ 11,866     $ 11,483    
                          

LIABILITIES AND STOCKHOLDERS’ EQUITY

        

Liabilities:

        

Current liabilities:

        

Accounts payable

   $ 137     $ 365     $ 436    

Accrued liabilities

     173       521       1,032    

Capital lease obligation

     —         —         34    

Deferred revenue

     —         2,500       3,175    
                          

Total current liabilities

     310       3,386       4,677    

Capital lease obligation—non-current

     —         —         77    

Deferred revenue—non-current

     —         6,667       6,042    
                          

Total liabilities

     310       10,053       10,796    
                          

Commitments and contingencies (note 7)

        

Stockholders’ Equity:

        

Convertible preferred stock

        

Series A, $0.01 par value; 4,000 shares authorized at all periods; 3,215 shares issued and outstanding at all periods; no shares outstanding pro forma; liquidation value of $1,286 at all periods

     32       32       32    

Series B, $0.01 par value; 7,000 shares authorized at all periods; 6,865 shares issued and outstanding at all periods; no shares outstanding pro forma; liquidation value of $3,226 at all periods

     69       69       69    

Series C, $0.01 par value; 8,000 shares authorized at all periods; 6,666 shares issued and outstanding at all periods; no shares outstanding pro forma; liquidation value of $5,667 at all periods

     67       67       67    

Series D, $0.01 par value; 20,000 shares authorized at all periods; 742, 2,481 and 2,481 shares issued and outstanding at December 31, 2005 and 2006 and March 31, 2007, respectively; no shares outstanding pro forma; liquidation value of $1,113, $3,722 and $3,722 at December 31, 2005 and 2006 and March 31, 2007, respectively

     7       24       24    
                          

Total convertible preferred stock

     175       192       192    

Common stock, $0.01 par value; 64,000 shares authorized at all periods; 10,099, 12,623 and 12,978 shares issued and outstanding at December 31, 2005 and 2006 and March 31, 2007, respectively; 32,205 shares outstanding pro forma

     101       126       130     $ 322  

Additional paid-in capital

     10,768       14,557       14,309       14,309  

Accumulated other comprehensive income (loss)

     (4 )     12       23       23  

Accumulated deficit during development stage

     (7,788 )     (13,074 )     (13,967 )     (13,967 )
                                

Total stockholders’ equity

     3,252       1,813       687     $ 687  
                                

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

   $ 3,562     $ 11,866     $ 11,483    
                          

The accompanying notes are an integral part of these financial statements.

 

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NOVABAY PHARMACEUTICALS, INC.

(formerly NovaCal Pharmaceuticals, Inc.)

(a development stage company)

STATEMENTS OF OPERATIONS

(in thousands, except per share data)

 

    

Year Ended

December 31,

    Three Months Ended
March 31,
    Cumulative
Period from
July 1, 2002
(date of
development
stage
inception) to
March 31,
2007
 
     2004     2005     2006     2006     2007    
                      

(unaudited)

    (unaudited)  

REVENUE

            

License and collaboration revenue

   $ —       $ —       $ 1,533     $ —       $ 1,483     $ 3,016  
                                                

Total revenue

     —         —         1,533       —         1,483       3,016  

EXPENSES

            

Operating Expenses:

            

Research and development

     1,481       1,952       4,087       531       1,463       9,454  

General and administrative

     1,345       1,617       2,972       717       1,035       7,995  
                                                

Total operating expenses

     2,826       3,569       7,059       1,248       2,498       17,449  

Other income, net

     22       106       240       30       122       466  
                                                

Net loss before income taxes

     (2,804 )     (3,463 )     (5,286 )     (1,218 )     (893 )     (13,967 )

Provision for income taxes

     —         —         —         —         —         —    
                                                

Net loss

   $ (2,804 )   $ (3,463 )   $ (5,286 )   $ (1,218 )   $ (893 )   $ (13,967 )
                                                

Net loss per share:

            

Basic and diluted

   $ (0.32 )   $ (0.36 )   $ (0.46 )   $ (0.12 )   $ (0.07 )  

Shares used in per share calculations:

            

Basic and diluted

     8,755       9,704       11,429       10,133       12,831    

Pro forma net loss per share (unaudited):

            

Basic and diluted

       $ (0.18 )     $ (0.03 )  

Shares used in pro forma per share calculations (unaudited):

            

Basic and diluted

         29,935         32,058    

Stock-based compensation expense included above:

            

Research and development

   $ 11     $ 55     $ 86     $ 15     $ 63     $ 232  

General and administrative

     —         16       281       21       175       472  
                                                

Total stock-based compensation expense

   $ 11     $ 71     $ 367     $ 36     $ 238     $ 704  
                                                

The accompanying notes are an integral part of these financial statements.

 

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NOVABAY PHARMACEUTICALS, INC.

(formerly NovaCal Pharmaceuticals, Inc.)

(a development stage company)

STATEMENTS OF STOCKHOLDERS’ EQUITY

(in thousands)

 

    Preferred Stock   Common Stock  

Additional
Paid-In

Capital

 

Stock
Subscription

Receivable

   

Accumulated
Other
Comprehensive

Income (Loss)

 

Accumulated
Deficit During
Development

Stage

   

Total
Stockholders’

Equity

 
    Shares   Amount   Shares   Amount          

Balance at July 1, 2002

  —     $ —     —     $ —     $ —     $ —       $ —     $ —       $ —    
                                                       

Comprehensive loss:

                 

Net loss

  —       —     —       —       —       —         —       (544 )     (544 )
                       

Comprehensive loss

                    (544 )

Issuance of Series A preferred stock and common stock for acquisition of LLC

  2,723     27   7,804     78     423     —         —       —         528  

Issuance of stock options for services

  —       —     —       —       15     —         —       —         15  

Sale of stock warrants

  —       —     —       —       10     —         —       —         10  
                                                       

Balance at December 31, 2002

  2,723     27   7,804     78     448     —         —       (544 )     9  
                                                       

Comprehensive loss:

                 

Net loss

  —       —     —       —       —       —         —       (977 )     (977 )
                       

Comprehensive loss

                    (977 )

Issuance of Series A preferred stock

  492     5   —       —       192     —         —       —         197  

Issuance of Series B preferred stock net of issuance costs of $86

  3,258     33   —       —       1,413     —         —       —         1,446  

Issuance of stock

  —       —     50       7     —         —       —         7  

Issuance of stock for option exercises

  —       —     80     1     7     —         —       —         8  

Issuance of stock for warrant exercises

  —       —     274     3     107     —         —       —         110  

Issuance of stock options for services

  —       —     —       —       2     —         —       —         2  
                                                       

Balance at December 31, 2003

  6,473     65   8,208     82     2,176     —         —       (1,521 )     802  
                                                       

Comprehensive loss:

                 

Net loss

  —       —     —       —       —       —         —       (2,804 )     (2,804 )
                       

Comprehensive loss

                    (2,804 )

Issuance of Series B preferred stock net of issuance costs of $127

  2,694     27   —       —       1,112     —         —       —         1,139  

Issuance of Series B preferred stock upon conversion of notes

  913     9   —       —       420     —         —       —         429  

Issuance of Series C preferred stock net of issuance costs of $123

  6,311     63   —       —       5,178     (873 )     —       —         4,368  

Issuance of stock for option exercises

  —       —     10     —       1     —         —       —         1  

Issuance of stock for warrant exercises

  —       —     63     1     36     —         —       —         37  

Issuance of stock for Series B offering costs

  —       —     735     7     103     —         —       —         110  

Issuance of stock for services

  —       —     30     —       4     —         —       —         4  

Issuance of stock options for services

  —       —     —       —       7     —         —       —         7  
                                                       

Balance at December 31, 2004

  16,391     164   9,046     90     9,037     (873 )     —       (4,325 )     4,093  
                                                       

 

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Table of Contents

NOVABAY PHARMACEUTICALS, INC.

(formerly NovaCal Pharmaceuticals, Inc.)

(a development stage company)

STATEMENTS OF STOCKHOLDERS’ EQUITY—(Continued)

(in thousands)

    Preferred Stock   Common Stock  

Additional
Paid—In

Capital

   

Stock
Subscription

Receivable

 

Accumulated
Other
Comprehensive

Income (Loss)

   

Accumulated
Deficit During
Development

Stage

   

Total
Stockholders’

Equity

 
    Shares   Amount   Shares   Amount          

Comprehensive loss:

                 

Net loss

  —       —     —       —       —         —       —         (3,463 )     (3,463 )

Change in unrealized gains (losses) on investments, net of tax

  —       —     —       —       —         —       (4 )     —         (4 )
                       

Comprehensive loss

                    (3,467 )

Issuance of Series C preferred stock net of issuance costs of $140

  355     4   —       —       158       —       —         —         162  

Issuance of Series D preferred stock net of issuance costs of $36

  742     7   —       —       1,070       —       —         —         1,077  

Issuance of stock for option exercises

  —       —     100     1     11       —       —         —         12  

Issuance of stock for warrant exercises

  —       —     584     6     321       —       —         —         327  

Issuance of stock and options for Series C offering costs

  —       —     329     3     100       —       —         —         103  

Issuance of stock for services

  —       —     40     1     16       —       —         —         17  

Issuance of stock options for services

  —       —     —       —       55       —       —         —         55  

Proceeds from stock subscription receivable

  —       —     —       —       —         873     —         —         873  
                                                         

Balance at December 31, 2005

  17,488     175   10,099     101     10,768       —       (4 )     (7,788 )     3,252  
                                                         

Comprehensive loss:

                 

Net loss

  —       —     —       —       —         —       —         (5,286 )     (5,286 )

Change in unrealized gains (losses) on investments, net of tax

  —       —     —       —       —         —       16       —         16  
                       

Comprehensive loss

                    (5,270 )

Issuance of Series D preferred stock net of issuance costs of $114

  1,739     17   —       —       2,477       —       —         —         2,494  

Issuance of stock for option exercises

  —       —     159     1     22       —       —         —         23  

Issuance of stock for warrant exercises

  —       —     2,298     23     953       —       —         —         976  

Issuance of stock and options for Series D offering costs

  —       —     61     1     63       —       —         —         64  

Stock-based compensation expense related to employee and director stock options

  —       —     —       —       313       —       —         —         313  

Issuance of stock for services

  —       —     6     —       5       —       —         —         5  

Issuance of stock options for services

  —       —     —       —       49       —       —         —         49  

Initial public offering costs

  —       —     —       —       (93 )     —       —         —         (93 )
                                                         

Balance at December 31 2006

  19,227   $ 192   12,623   $ 126   $ 14,557     $ —     $ 12     $ (13,074 )   $ 1,813  
                                                         

Comprehensive loss:

                 

Net loss

  —       —     —       —       —         —       —         (893 )     (893 )

Change in unrealized gains (losses) on investments, net of tax

  —       —     —       —       —         —       11       —         11  
                       

Comprehensive loss

                    (882 )

Issuance of stock for option exercises

  —       —     285     3     47       —       —         —         50  

Issuance of stock for services

  —       —     70     1     79       —       —         —         80  

Issuance of stock options for services

  —       —     —       —       34       —       —         —         34  

Stock-based compensation expense related to employee and director stock options

  —       —     —       —       124       —       —         —         124  

Initial public offering costs

  —       —     —       —       (532 )     —       —         —         (532 )
                                                         

Balance at March 31, 2007 (unaudited)

  19,227   $ 192   12,978   $ 130   $ 14,309     $ —     $ 23     $ (13,967 )   $ 687  
                                                         

The accompanying notes are an integral part of these financial statements.

 

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NOVABAY PHARMACEUTICALS, INC.

(formerly NovaCal Pharmaceuticals, Inc.)

(a development stage company)

STATEMENTS OF CASH FLOWS

(in thousands)

 

    Year Ended
December 31,
   

Three Months
Ended

March 31,

   

Cumulative Period
from July 1, 2002
(date of
development stage
inception) to

March 31,

2007

 
    2004     2005     2006     2006     2007    
                      (unaudited)     (unaudited)  

Cash flows from operating activities:

           

Net loss

  $ (2,804 )   $ (3,463 )   $ (5,286 )   $ (1,218 )   $ (893 )   $ (13,967 )

Adjustments to reconcile net loss to net cash used in operating activities:

           

Depreciation and amortization

    40       48       74       15       34       251  

Accretion of discount on short-term investments

    —         —         (32 )     —         (28 )     (60 )

Net realized (gain) loss on sales of short-term investments

    —         12       20       3       (22 )     10  

Loss on disposal of property and equipment

    120       —         1       —         —         121  

Stock-based compensation expense for options issued to employees and directors

    —         —         313       19       124       437  

Stock-based compensation expense for options and stock issued to non-employees

    11       71       54       17       114       267  

Taxes paid by LLC

    —         —         —         —         —         1  

Changes in operating assets and liabilities:

           

(Increase) decrease in prepaid expenses and other assets

    (100 )     38       (143 )     (35 )     (281 )     (502 )

Increase in accounts payable and accrued liabilities

    193       64       576       323       582       1,493  

Increase in deferred revenue

    —         —         9,167       —         50       9,217  
                                               

Net cash provided by (used in) operating activities

    (2,540 )     (3,230 )     4,744       (876 )     (320 )     (2,732 )
                                               

Cash flows from investing activities:

           

Purchases of property and equipment

    (162 )     (123 )     (362 )     (72 )     (287 )     (1,174 )

Proceeds from disposal of property and equipment

    1       1       1       —         —         43  

Purchases of short-term investments

    —         (1,957 )     (11,293 )     (214 )     (9,148 )     (22,398 )

Proceeds from maturities and sales of short-term investments

    —         936       6,141       430       9,200       16,277  

Cash acquired in purchase of LLC

    —         —         —         —         —         516  
                                               

Net cash provided by (used in) investing activities

    (161 )     (1,143 )     (5,513 )     144       (235 )     (6,736 )
                                               

Cash flows from financing activities:

           

Proceeds from preferred stock issuances, net

    5,617       1,342       2,558       178       —         11,160  

Proceeds from common stock issuances

    —         —         —         —         —         7  

Proceeds from exercise of options and warrants

    38       339       999       31       50       1,544  

Initial public offering costs

    —         —         (93 )     —         (532 )     (625 )

Proceeds from stock subscription receivable

    —         873       —         —         —         873  

Proceeds from sale of warrant rights

    —         —         —         —         —         10  

Proceeds from issuance of notes

    —         —         —         —         —         405  

Principal payments on capital lease

    (11 )     (20 )     —         —         (5 )     (45 )
                                               

Net cash provided by (used in) financing activities

    5,644       2,534       3,464       209       (487 )     13,329  
                                               

Net increase (decrease) in cash and cash equivalents

    2,943       (1,839 )     2,695       (523 )     (1,042 )     3,861  

Cash and cash equivalents, beginning of period

    1,104       4,047       2,208       2,208       4,903       —    
                                               

Cash and cash equivalents, end of period

  $ 4,047     $ 2,208     $ 4,903     $ 1,685     $ 3,861     $ 3,861  
                                               

Supplemental disclosure of cash flow information:

           

Interest paid

  $ 3     $ 1     $ 2     $ 2     $ —       $ 10  

Income taxes paid

  $ —       $ —       $ —       $ —       $ —       $ —    

Non-cash activities:

           

Conversion of notes and accrued interest to preferred stock

  $ 429     $ —       $ —       $ —       $ —       $ 429  

Issuance of stock for subscription receivable

  $ 873     $ —       $ —       $ —       $ —       $ 873  

Issuance of stock and options for stock offering costs

  $ 110     $ 103     $ 64     $ —       $ —       $ 277  

Current assets acquired in acquisition of LLC

  $ —       $ —       $ —       $ —       $ —       $ 2  

Property and equipment acquired in acquisition of LLC

  $ —       $ —       $ —       $ —       $ —       $ 9  

The accompanying notes are an integral part of these financial statements.

 

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Table of Contents

NOVABAY PHARMACEUTICALS, INC.

(formerly NovaCal Pharmaceuticals, Inc.)

(a development stage company)

NOTES TO FINANCIAL STATEMENTS

NOTE 1. ORGANIZATION

NovaBay Pharmaceuticals, Inc. (“we,” “our,” “us,” “NovaBay” or the “Company”) is a biopharmaceutical company focused on developing innovative product candidates targeting the treatment or prevention of a wide range of infections in hospital and non-hospital environments. Many of these infections have become increasingly difficult to treat because of the rapid increase in infectious agents that have become resistant to current drugs.

We have developed a class of antimicrobial compounds, which we have named Aganocide compounds, that we believe could form a platform on which to create a variety of products to address differing needs in the antimicrobial area. Our antimicrobial compounds are based upon small molecules that are generated by white blood cells and that enable them to perform their function of defending the body against invading pathogens. In the body, these compounds are produced “on demand” and are transient. We have focused our efforts on understanding these molecules and finding ways, primarily by chemical modification, to impart qualities to allow them to be developed as therapeutic products.

Our current development efforts are focused on Aganocide compounds to treat patients with infections of the eye, ear and sinus, to create an improved environment for the healing of wounds, whether chronic or acute, and to prevent infections that either result from surgical or other hospital procedures, or that can be caused by the use of products, such as contact lens solutions, which can introduce an infection into the body. We operate in one business segment.

We were incorporated under the laws of the State of California on January 19, 2000 as NovaCal Pharmaceuticals, Inc. We had no operations until July 1, 2002, on which date we acquired all of the operating assets of NovaCal Pharmaceuticals, LLC (“LLC”), a California limited liability company, in exchange for the issuance of 7.8 million and 2.7 million shares of our common stock and Series A preferred stock, respectively. Additionally, we issued warrants to purchase an aggregate of 1,089,000 shares of our common stock to certain holders of common and preferred units of the LLC. Under this transaction, we acquired cash, property and equipment, and other current assets of $516,000, $9,000 and $2,000, respectively. The transaction was accounted for using the purchase method of accounting.

In February 2007, we changed our name to NovaBay Pharmaceuticals, Inc. See Note 13 for information pertaining to the corporate name change.

NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and are expressed in U.S. dollars. The financial statements have been prepared under the guidelines of Statement of Financial Accounting Standard (“SFAS”) No. 7, “Accounting and Reporting by Development Stage Enterprises”. A development stage enterprise is one in which planned principal operations have not commenced, or if its operations have commenced, there have been no significant revenues therefrom. As of March 31, 2007, we have not commenced our planned principal operations.

The interim financial statements as of March 31, 2007 and for the three months ended March 31, 2006 and 2007 and the cumulative period from July 1, 2002 to March 31, 2007 are unaudited. The unaudited interim

 

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Table of Contents

NOVABAY PHARMACEUTICALS, INC.

(formerly NovaCal Pharmaceuticals, Inc.)

(a development stage company)

NOTES TO FINANCIAL STATEMENTS—(Continued)

 

financial statements have been prepared on the same basis as the audited annual financial statements and, in our opinion, reflect all adjustments necessary for a fair statement of our financial position, results of operations and cash flows. The results for the three months ended March 31, 2007 are not necessarily indicative of the expected results for the year ended December 31, 2007. Certain amounts for prior periods have been reclassified to conform to the March 31, 2007 presentation.

Use of Estimates

The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates.

Cash and Cash Equivalents and Short-Term Investments

We consider all highly liquid instruments with a stated maturity of three months or less to be cash and cash equivalents. Cash and cash equivalents are stated at cost, which approximates fair value, based on quoted market prices. Cash is deposited in institutions that are generally federally insured in limited amounts.

We classify all highly liquid investments with a stated maturity of greater than three months as short-term investments. We have classified our short-term investments as “available-for-sale”. We do not intend to hold securities with stated maturities greater than twelve months until maturity. In response to changes in the availability of and the yield on alternative investments as well as liquidity requirements, we occasionally sell these securities prior to their stated maturities. All short-term investments are recorded at fair value and unrealized gains and losses are recorded as a separate component of stockholders’ equity (deficit) until realized. Realized gains and losses on sale of all such securities are reported in earnings, computed using the specific identification cost method.

Property and Equipment

Property and equipment are stated at cost, less accumulated depreciation and amortization. Depreciation is calculated using the straight line method over the estimated useful lives of the related assets of five to seven years for office and laboratory equipment, three years for software and seven years for furniture and fixtures. Leasehold improvements are depreciated on the shorter of seven years or the life of the lease term. Depreciation of assets recorded under capital leases is included in depreciation expense.

The costs of normal maintenance, repairs, and minor replacements are charged to operations when incurred.

Fair Value of Financial Instruments

The carrying values of financial instruments such as cash and cash equivalents, short-term investments, accounts payable, and accrued liabilities approximate their fair values due to the short settlement period for these instruments.

Impairment of Long-Lived Assets

We account for long-lived assets in accordance with SFAS No. 144, “Accounting for the Impairment or Disposal of Long-Lived Assets and for Long-Lived Assets to be Disposed of”, which requires that companies

 

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Table of Contents

NOVABAY PHARMACEUTICALS, INC.

(formerly NovaCal Pharmaceuticals, Inc.)

(a development stage company)

NOTES TO FINANCIAL STATEMENTS—(Continued)

 

consider whether events or changes in facts and circumstances, both internally and externally, may indicate that an impairment of long-lived assets held for use are present. Management periodically evaluates the carrying value of long-lived assets and has determined that there was no impairment as of all periods presented. Should there be impairment in the future, we would recognize the amount of the impairment based on the expected future cash flows from the impaired assets. The cash flow estimates would be based on management’s best estimates, using appropriate and customary assumptions and projections at the time.

Accumulated Other Comprehensive Income (Loss)

Accumulated other comprehensive income (loss) consists of net income and other related gains and losses affecting stockholders’ equity that, under generally accepted accounting principles, are excluded from net income. At December 31, 2005 and 2006 and March 31, 2007, other comprehensive income (loss) consisted of net unrealized gains and losses on short-term investments classified as available-for-sale. We had no other comprehensive income (loss) items during 2002, 2003 and 2004.

Revenue Recognition

License and collaboration revenue is primarily generated through an agreement with a strategic partner for the development and commercialization of our product candidates. We may enter into additional agreements with other strategic partners as opportunities arise. The terms of such agreements may include non-refundable upfront fees, funding of research and development activities, payments based upon achievement of certain milestones and royalties on net product sales. In accordance with Emerging Issues Task Force (“EITF”) Issue No. 00-21, “Revenue Arrangements with Multiple Deliverables”, we analyze our multiple element arrangements to determine whether the elements can be separated. We perform our analysis at the inception of the arrangement and as each product or service is delivered. If a product or service is not separable, the combined deliverables are accounted for as a single unit of accounting and recognized over the performance obligation period. We recognize revenue in accordance with SEC Staff Accounting Bulletin (“SAB”) No. 101, “Revenue Recognition in Financial Statements”, as amended by SAB No. 104 (together, “SAB 104”). In accordance with SAB 104, revenue is recognized when the following criteria have been met: persuasive evidence of an arrangement exists; delivery has occurred and risk of loss has passed; the seller’s price to the buyer is fixed or determinable and collectibility is reasonably assured.

Assuming the elements meet the EITF No. 00-21 criteria for separation and the SAB 104 requirements for recognition, the revenue recognition methodology prescribed for each unit of accounting is summarized below:

Upfront Fees —We defer recognition of non-refundable upfront fees if we have continuing performance obligations without which the technology licensed has no utility to the licensee. If we have continuing involvement through research and development services that are required because our know-how and expertise related to the technology is proprietary to us, or can only be performed by us, then such up-front fees are deferred and recognized over the period of continuing involvement.

Funded Research and Development— Revenue from research and development services is recognized during the period in which the services are performed and is based upon the number of full-time-equivalent personnel working on the specific project at the agreed-upon rate. Reimbursements from collaborative partners for agreed upon direct costs including direct materials and outsourced, or subcontracted, pre-clinical studies are classified as revenue in accordance with EITF Issue No. 99-19, “Reporting Revenue Gross as a Principal versus Net as an Agent,” and recognized in the period the reimbursable expenses are incurred. Payments received in advance are recorded as deferred revenue until the research and development services are performed or costs are incurred.

 

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Table of Contents

NOVABAY PHARMACEUTICALS, INC.

(formerly NovaCal Pharmaceuticals, Inc.)

(a development stage company)

NOTES TO FINANCIAL STATEMENTS—(Continued)

 

Milestones —Substantive milestone payments are considered to be performance bonuses that are recognized upon achievement of the milestone only if all of the following conditions are met: the milestone payments are non-refundable; achievement of the milestone involves a degree of risk and was not reasonably assured at the inception of the arrangement; substantive effort is involved in achieving the milestone; the amount of the milestone is reasonable in relation to the effort expended or the risk associated with achievement of the milestone; and a reasonable amount of time passes between the up-front license payment and the first milestone payment as well as between each subsequent milestone payment. If any of these conditions are not met, the milestone payments are deferred and recognized as revenue over the term of the arrangement as we complete our performance obligations.

Royalties —We recognize royalty revenues from licensed products upon the sale of the related products.

Advertising Costs

There were no advertising costs incurred for any of the periods presented.

Research and Development Costs

We charge research and development costs to expense as incurred. These costs consist of direct and indirect costs associated with specific projects, as well as fees paid to entities that perform research and clinical trial studies on our behalf.

Patent Costs

We expense patent costs, including legal expenses, in the period in which they are incurred. Patent expenses are included as general and administrative expenses in our statements of operations.

Stock-Based Compensation

On January 1, 2006, we adopted the fair value recognition provisions of SFAS No. 123R, “Share-Based Payment”. SFAS No. 123R replaced SFAS No. 123 and superseded Accounting Principles Board (“APB”) Opinion No. 25, “Accounting for Stock Issued to Employees,” and related interpretations. Under the fair value recognition provisions of SFAS No. 123R, stock-based compensation expense is measured at the grant date for all stock-based awards to employees and directors and is recognized as expense over the requisite service period, which is generally the vesting period. We were required to utilize the prospective application method prescribed by SFAS No. 123R, under which prior periods are not revised for comparative purposes. Under the prospective application transition method, non-public entities that previously used the minimum value method of SFAS No. 123 should continue to account for non-vested equity awards outstanding at the date of adoption of SFAS No. 123R in the same manner as they had been accounted for prior to adoption. SFAS No. 123R specifically prohibits pro forma disclosures for those awards valued using the minimum value method. The valuation and recognition provisions of SFAS No. 123R apply to new awards and to awards outstanding as of the adoption date that are subsequently modified.

Prior to the adoption of SFAS No. 123R, we accounted for stock-based compensation awards to employees using the intrinsic value method under the recognition and measurement principles of APB Opinion No. 25. Our application of APB Opinion No. 25 did not result in compensation expense because the exercise price of the stock-based awards was equal to the fair market value of the stock at the grant date.

 

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Table of Contents

NOVABAY PHARMACEUTICALS, INC.

(formerly NovaCal Pharmaceuticals, Inc.)

(a development stage company)

NOTES TO FINANCIAL STATEMENTS—(Continued)

 

We account for stock compensation arrangements with non-employees in accordance with SFAS No. 123R and EITF Issue No. 96-18, “Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services”, using a fair value approach. For stock options granted to non-employees, the fair value of the stock options is estimated using a Black-Scholes-Merton valuation model.

The adoption of SFAS No. 123R had a material effect on our financial position and results of operations. See Note 8 for further information regarding stock-based compensation expense and the assumptions used in estimating that expense.

Income Taxes

We account for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is recognized if it is more likely than not that some portion or all of the deferred tax asset will not be recognized.

Net Income (Loss) per Share

We compute net income (loss) per share in accordance with SFAS No. 128, “Earnings per Share” which requires presentation of both basic and diluted earnings (loss) per share (“EPS”).

Basic EPS is computed by dividing net income (loss) available to common shareholders (numerator) by the weighted average number of common shares outstanding (denominator) during the period. Diluted EPS gives effect to all dilutive potential common shares outstanding during the period including stock options and stock warrants, using the treasury stock method, and convertible preferred stock, using the if-converted method. In computing diluted EPS, the average stock price for the period is used in determining the number of shares assumed to be purchased from the exercise of stock options or warrants. Potentially dilutive common share equivalents are excluded from the diluted EPS computation in net loss periods as their effect would be anti-dilutive. See Note 12 for further information regarding the calculation of net income (loss) per share.

Recently Issued Accounting Pronouncements

In July 2006, the Financial Accounting Standards Board (“FASB”) issued FASB Interpretation No. 48, “Accounting for Uncertainty in Income Taxes” (“FIN 48”). FIN 48 clarifies the accounting and reporting for uncertainties in income tax law. FIN 48 prescribes a comprehensive model for the financial statement recognition, measurement, presentation, and disclosure of uncertain tax positions taken or expected to be taken in income tax returns. FIN 48 is effective for fiscal years beginning after December 15, 2006. The adoption of FIN 48 did not have a material impact on our financial position or results of operations.

In September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements”. SFAS No. 157 establishes a framework for measuring the fair value of assets and liabilities. This framework is intended to provide increased consistency in how fair value determinations are made under various existing accounting

 

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Table of Contents

NOVABAY PHARMACEUTICALS, INC.

(formerly NovaCal Pharmaceuticals, Inc.)

(a development stage company)

NOTES TO FINANCIAL STATEMENTS—(Continued)

 

standards which permit, or in some cases require, estimates of fair market value. SFAS No. 157 is effective for fiscal years beginning after November 15, 2007, and interim periods within those fiscal years. Earlier application is encouraged, provided that the reporting entity has not yet issued financial statements for that fiscal year, including any financial statements for an interim period within that fiscal year. We are currently assessing the impact of SFAS No. 157 on our financial position and results of operations.

In February, 2007, the FASB issued SFAS No. 159 “The Fair Value Option for Financial Assets and Financial Liabilities”. SFAS No. 159 permits entities to choose to measure many financial assets and financial liabilities at fair value. Unrealized gains and losses on items for which the fair value option has been elected are reported in earnings. SFAS No. 159 is effective for fiscal years beginning after November 15, 2007. We are currently assessing the impact of SFAS No. 159 on our financial position and results of operations.

NOTE 3. SHORT-TERM INVESTMENTS

Short-term investments at December 31, 2005 and 2006 and March 31, 2007 consisted of the following:

 

     December 31, 2005
     Amortized Cost    Gross
Unrealized
Gains
   Gross
Unrealized
Losses
    Market Value
     (in thousands)

Corporate bonds

   $ 334    $  —      $ (4 )   $ 330

U.S. Treasuries

     551      2      (3 )     550

U.S. Agencies

     125      —        (1 )     124
                            

Total

   $ 1,010    $ 2    $ (8 )   $ 1,004
                            

 

     December 31, 2006
       Amortized Cost    Gross
Unrealized
Gains
   Gross
Unrealized
Losses
   Market Value
     (in thousands)

Corporate bonds

   $ 3,778    $ 8    $  —      $ 3,786

Municipal bonds

     200      —        —        200

U.S. Agencies

     2,193      4      —        2,197
                           

Total

   $ 6,171    $ 12    $ —      $ 6,183
                           

 

     March 31, 2007
       Amortized Cost    Gross
Unrealized
Gains
   Gross
Unrealized
Losses
   Market Value
    

(unaudited)

(in thousands)

Corporate bonds

   $ 3,778    $ 19    $  —      $ 3,797

Municipal bonds

     200      —        —        200

U.S. Agencies

     2,191      4      —        2,195
                           

Total

   $ 6,169    $ 23    $ —      $ 6,192
                           

 

F-13


Table of Contents

NOVABAY PHARMACEUTICALS, INC.

(formerly NovaCal Pharmaceuticals, Inc.)

(a development stage company)

NOTES TO FINANCIAL STATEMENTS—(Continued)

 

Contractual maturities of short-term investments as of March 31, 2007 were as follows:

 

     March 31, 2007
     Amortized
Cost
   Market
Value
    

(unaudited)

(in thousands)

Due in one year or less

   $ 4,769    $ 4,792

Due after ten years

     1,400      1,400
             

Total

   $ 6,169    $ 6,192
             

During the years ended December 31, 2005 and 2006, we recognized a net realized loss on sales or maturities of short-term investments of $12,000 and $20,000, respectively. For the three months ended March 31, 2006 and 2007, we recognized a net realized loss of $3,000 and a net realized gain of $22,000, respectively.

 

NOTE 4. PROPERTY AND EQUIPMENT

 

Property and equipment consisted of the following:

 

   

 

 

               December 31,     March 31,  
                 2005     2006     2007  
                     (unaudited)  
               (in thousands)  

Office and laboratory equipment

   $ 242     $ 550     $ 886  

Furniture and fixtures

     58       88       92  

Software

     13       31       58  

Leasehold equipment

     33       36       72  
                        

Total property and equipment, cost

     346       705       1,108  

Less: accumulated depreciation

     (79 )     (151 )     (185 )
                              

Total property and equipment, net

   $ 267     $ 554     $ 923  
                              

 

Depreciation expense was $40,000, $48,000 and $74,000 for the years ended December 31, 2004, 2005 and 2006, respectively, $15,000 and $34,000 for the three months ended March 31, 2006 and 2007, respectively, and $251,000 for the cumulative period from July 1, 2002 (date of development stage inception) to March 31, 2007.

 

NOTE 5. ACCRUED LIABILITIES

 

Accrued liabilities consisted of the following:

 

    

 

 

              

December 31,

    March 31,  
                

2005

    2006     2007  
                     (unaudited)  
               (in thousands)  

Research and development

   $ 99     $ 225     $ 366  

Employee payroll and benefits

Professional fees

     74       119       100  
     —         143       476  

Other

     —         34       90  
                              

Total accrued liabilities

   $ 173     $ 521     $ 1,032  
                        

 

F-14


Table of Contents

NOVABAY PHARMACEUTICALS, INC.

(formerly NovaCal Pharmaceuticals, Inc.)

(a development stage company)

NOTES TO FINANCIAL STATEMENTS—(Continued)

 

NOTE 6. CAPITAL LEASE OBLIGATION

During the first quarter of 2007, we commenced a lease for a portion of our laboratory equipment. This arrangement is being accounted for as a capital lease. Assets under capital leases that are included in property and equipment are as follows:

 

     March 31,
2007
 
     (unaudited)  
     (in thousands)  

Office and laboratory equipment

   $ 166  

Less: accumulated depreciation

     (1 )
        

Capital lease assets, net

   $ 165  
        

Future minimum lease payments under capital leases were as follows at March 31, 2007:

 

     Lease
Commitment
 
     (unaudited)  
     (in thousands)  

Year ending December 31:

  

2007

   $ 33  

2008

     45  

2009

     45  

2010

     7  
        

Total minimum lease payments

     130  

Less: amount representing interest

     (19 )
        

Present value of minimum lease payments

   $ 111  
        

During 2005, we leased $40,000 of property and equipment under a capital lease with California Pacific Labs, Inc., a related party. Accumulated depreciation associated with the leased equipment was $18,000 at December 31, 2005. Effective December 31, 2005, we exercised our option to terminate the lease and purchased the equipment at the remaining lease obligation amount of $8,000.

NOTE 7. COMMITMENTS AND CONTINGENCIES

Operating Leases

We lease laboratory facilities and office space under operating leases which expire at various dates through 2011. Rent expense was $103,000, $270,000 and $317,000 for the years ended December 31, 2004, 2005, and 2006, respectively. Rent expense was $78,000 and $133,000 for the three months ended March 31, 2006 and 2007, respectively. For the cumulative period from July 1, 2002 (date of development stage inception) to March 31, 2007, rent expense was $928,000.

 

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Table of Contents

NOVABAY PHARMACEUTICALS, INC.

(formerly NovaCal Pharmaceuticals, Inc.)

(a development stage company)

NOTES TO FINANCIAL STATEMENTS—(Continued)

 

The future minimum lease payments under non-cancellable operating leases were as follows as of March 31, 2007:

 

       Lease Commitment
     (unaudited)
     (in thousands)

Year ending December 31:

  

2007

   $ 393

2008

     548

2009

     508

2010

     200

2011

     208
      

Total lease commitment

   $ 1,857
      

Legal Matters

From time to time, we may be involved in various legal proceedings arising in the ordinary course of business. There are no matters at March 31, 2007 that, in the opinion of management, would have a material adverse effect on our financial position, results of operations or cash flows.

NOTE 8. STOCKHOLDERS’ EQUITY

Convertible Preferred Stock

In 2002 and 2003, we issued 3.2 million shares of Series A Convertible Preferred Stock (“Series A”) for net proceeds of $647,000. In 2003 and 2004, we issued 6.9 million shares of Series B Convertible Preferred Stock (“Series B”) for net proceeds of $3.0 million. In 2004 and 2005, we issued 6.7 million shares of Series C Convertible Preferred Stock (“Series C”) for net proceeds of $5.4 million. In 2005 and 2006, we issued 2.5 million shares of Series D Convertible Preferred Stock (“Series D”) for net proceeds of $3.6 million. Preferred shares authorized were 19 million at December 31, 2004 and 39 million at December 31, 2005 and 2006.

Significant terms of the Series A, Series B, Series C and Series D are as follows:

 

   

Preferred stock is convertible into common stock at the option of the shareholder or automatically in the event of a public offering of our common stock or in the event we are acquired at a price that exceeds the liquidation preference of the outstanding preferred stock. The conversion rate is one to one, subject to anti-dilution adjustments.

 

   

The preferred stock have liquidation preferences equal to $0.40 for Series A, $0.47 for Series B, $0.85 for Series C and $1.50 for Series D.

 

   

Voting rights are equal to those of the underlying common stock, except that Series B holders have the right to elect one member of the Board of Directors and holders of Series C and Series D voting together have the right to elect one member of the Board of Directors.

 

   

Dividends are payable at the discretion of the Board. In the event that dividends are declared on common stock, holders of preferred stock shall be entitled to receive $0.02 per share. To date, no dividends have been declared.

 

F-16


Table of Contents

NOVABAY PHARMACEUTICALS, INC.

(formerly NovaCal Pharmaceuticals, Inc.)

(a development stage company)

NOTES TO FINANCIAL STATEMENTS—(Continued)

 

   

In the event that we issue shares to investors under terms that are more favorable to those investors than those granted to the Series D within a certain time period, then the Series D holders have the right to exchange their stock for new stock issued under the more favorable terms.

Common Stock

The holders of common stock are entitled to one vote per share on matters submitted to shareholders. The common stock carries dividends as declared by the Board. As of March 31, 2007, we have not declared any dividends to the holders of our common stock.

The number of authorized shares of common stock to be issued was amended by our Board of Directors on May 20, 2004 and June 9, 2005 to 44 million and 64 million shares, respectively. The following table summarizes the common shares available for issuance:

 

     December 31,     March 31,  
       2005     2006     2007  
                 (unaudited)  
     (in thousands)  

Authorized

   64,000     64,000     64,000  

Issued and outstanding

   (10,099 )   (12,623 )   (12,978 )
                  

Available for issuance

   53,901     51,377     51,022  
                  

Reserved for future issuance:

      

For conversion of Series A

   3,215     3,215     3,215  

For conversion of Series B

   6,865     6,865     6,865  

For conversion of Series C

   6,666     6,666     6,666  

For conversion of Series D

   742     2,481     2,481  

Outstanding stock warrants

   2,656     —       —    

Outstanding stock options

   3,565     4,791     4,932  

Possible future issuance under stock option plans

   2,424     836     395  
                  

Total reserved for future issuance

   26,133     24,854     24,554  
                  

Stock Warrants

Stock warrants to acquire shares of common stock were issued in connection with the sales of Series A and Series B and the convertible notes. The significant terms of the Series A, Series B and Note Warrants were as follows:

 

   

Series A Warrants —The warrants issued with the sale of Series A were issued on the basis of 0.40 of a warrant for every share of Series A purchased. The warrants expired on July 1, 2005, except for later purchases for which the expiration date was extended to July 1, 2006. The exercise price of these warrants was $0.60. We extended a limited-time offer to holders of the warrants to exercise them at a price of $0.40.

 

   

Series B Warrants —The warrants issued with the sale of Series B were issued on the basis of 0.35 of a warrant for every share of Series B purchased. The warrants expired on June 30, 2006. The exercise price of these warrants was $0.40.

 

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Table of Contents

NOVABAY PHARMACEUTICALS, INC.

(formerly NovaCal Pharmaceuticals, Inc.)

(a development stage company)

NOTES TO FINANCIAL STATEMENTS—(Continued)

 

   

Note Warrants —Stock warrants were granted in connection with promissory notes issued to certain of our shareholders in 2002 and 2003. The notes converted into shares of our Series B preferred stock in January of 2004. The stock warrants issued to these shareholders had an exercise price of $0.60 per share and an expiration date of June 30, 2006.

The following table summarizes our stock warrant activities:

 

    

Warrants

    Weighted Average
Exercise Price
     (in thousands, except per share data)

Balance at December 31, 2004

   3,486     $ 0.46
        

Warrants issued

   5     $ 0.40

Warrants expired

   (251 )   $ 0.60

Warrants exercised

   (584 )   $ 0.56
        

Balance at December 31, 2005

   2,656     $ 0.43
        

Warrants issued

   —         —  

Warrants expired

   (358 )   $ 0.45

Warrants exercised

   (2,298 )   $ 0.43
        

Balance at December 31, 2006

   —         —  
        

Balance at March 31, 2007

   —         —  
        

Stock Option Plans

We have two stock option plans. In June 2002, we adopted a stock option plan (“2002 Plan”) under which 2.5 million shares of common stock had been reserved. In May 2003, the number of shares reserved under the 2002 Plan was increased to 4.5 million shares. In May 2005, we adopted an additional but substantially similar plan (“2005 Plan”) under which 2.5 million shares of common stock were reserved for grant under the plan. Under these plans, shares subject to options that terminate or expire may be re-issued. In conjunction with the adoption of the 2005 Plan, the Board stipulated that no further options may be granted from the 2002 Plan and any option terminations or expirations from the 2002 Plan may not be re-issued. At December 31, 2005 and 2006 and March 31, 2007, there were 2.4 million, 0.8 million and 0.4 million shares, respectively, of our common stock available for option grants under the 2005 Plan.

The options typically expire ten years from the date of grant or three months from the end of an employee’s employment with us. Options granted to employees generally vest over four years while options granted to directors, Advisory Board members and consultants typically vest over two years or less, subject to continued service. Under the terms of these plans, the option exercise price may not be less than 100% of the fair market value of the common stock on the date of grant. The Board of Directors estimates the fair market value of a share of common stock upon each grant of stock options. All of the options include early exercise provisions that allow for full exercise of the option prior to option vesting, subject to certain repurchase provisions.

 

F-18


Table of Contents

NOVABAY PHARMACEUTICALS, INC.

(formerly NovaCal Pharmaceuticals, Inc.)

(a development stage company)

NOTES TO FINANCIAL STATEMENTS—(Continued)

 

Stock Option Activity

The following table summarizes our stock option activities:

 

    

Year Ended

December 31,

  

Three Months

Ended

March 31,

     2005    2006    2007
       Options     Weighted
Average
Exercise
Price
   Options     Weighted
Average
Exercise
Price
   Options     Weighted
Average
Exercise
Price
                           (unaudited)
     (in thousands, except per share data)

Outstanding and exercisable at beginning of period

   3,286     $ 0.16    3,565     $ 0.23    4,791     $ 0.42

Options granted

   931     $ 0.55    1,644     $ 0.78    449     $ 1.14

Options exercised

   (100 )   $ 0.12    (159 )   $ 0.14    (285 )   $ 0.18

Options forfeited/cancelled

   (552 )   $ 0.36    (259 )   $ 0.34    (23 )   $ 0.60
                          

Outstanding and exercisable at end of period

   3,565     $ 0.23    4,791     $ 0.42    4,932     $ 0.49
                          

Vested at end of period

   2,808     $ 0.25    3,263     $ 0.33    3,341     $ 0.37

The following table summarizes information about options outstanding at December 31, 2006:

 

     Options Outstanding and Exercisable    Options Vested

Range of Exercise Prices

   Number
Outstanding
and
Exercisable
   Weighted
Average
Remaining
Contractual
Life (yrs)
   Weighted
Average
Exercise
Price
   Aggregate
Intrinsic
Value
   Number
Vested
   Weighted
Average
Exercise
Price
   Aggregate
Intrinsic
Value
   (in thousands, except per share data)

$0.10

   1,367    5.18    $ 0.10       1,267    $ 0.10   

$0.15

   865    6.76    $ 0.15       575    $ 0.15   

$0.28

   479    7.47    $ 0.28       452    $ 0.28   

$0.47 - $0.60

   698    7.95    $ 0.58       318    $ 0.56   

$0.85

   1,278    9.17    $ 0.85       625    $ 0.85   

$0.94 - $1.00

   104    9.35    $ 0.98       26    $ 0.94   
                        
   4,791    7.25    $ 0.42    $ 3,468    3,263    $ 0.33    $ 2,648
                        

 

F-19


Table of Contents

NOVABAY PHARMACEUTICALS, INC.

(formerly NovaCal Pharmaceuticals, Inc.)

(a development stage company)

NOTES TO FINANCIAL STATEMENTS—(Continued)

 

The following table summarizes information about options outstanding at March 31, 2007:

 

     Options Outstanding and Exercisable    Options Vested

Range of Exercise Prices

   Number
Outstanding
and
Exercisable
   Weighted
Average
Remaining
Contractual
Life (yrs)
   Weighted
Average
Exercise
Price
   Aggregate
Intrinsic
Value
   Number
Vested
   Weighted
Average
Exercise
Price
   Aggregate
Intrinsic
Value
     (unaudited)
     (in thousands, except per share data)

$0.10

   1,237    4.95    $ 0.10       1,130    $ 0.10   

$0.15

   755    6.67    $ 0.15       570    $ 0.15   

$0.28

   474    7.22    $ 0.28       450    $ 0.28   

$0.47 - $0.60

   635    7.60    $ 0.58       323    $ 0.56   

$0.85

   1,278    8.92    $ 0.85       826    $ 0.85   

$0.94 - $1.00

   104    9.10    $ 0.98       25    $ 0.94   

$1.14

   449    9.65    $ 1.14       17    $ 1.14   
                        
   4,932    7.32    $ 0.49    $ 3,186    3,341    $ 0.37    $ 2,559
                        

The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying stock option awards and the fair value of our common stock at December 31, 2006 and March 31, 2007. For the years ended December 31, 2004, 2005 and 2006 and for the three months ended March 31, 2007, the aggregate intrinsic value of stock option awards exercised was $1,800, $16,000, $126,000 and $275,000, respectively, determined at the date of option exercise. We received cash payments in the amount of $1,000, $12,000, $23,000 and $50,000 for the exercise of stock options during the years ended December 31, 2004, 2005 and 2006 and during the three months ended March 31, 2007, respectively.

Valuation of Stock-Based Awards to Employees and Directors

We grant options to purchase common stock to some of our employees and directors at prices equal to or greater than the fair value of the stock on the dates the options are granted. We have estimated the value of certain stock option awards as of the date of the grant by applying the Black-Scholes-Merton option pricing valuation model using the single-option valuation approach. The application of this valuation model involves assumptions that are judgmental and subjective in nature. See Note 2 for a description of the accounting policies that we applied to value our stock-based awards.

The weighted average key assumptions used in determining the value of options granted and a summary of the methodology applied to develop each assumption are as follows:

 

    

Year Ended

December 31,

    Three Months
Ended
March 31,
 

Assumption

   2004     2005     2006     2007  
                          

Expected price volatility

     0.0 %     0.0 %     74.0 %     72.0 %

Expected life (in years)

     10.0       10.0       5.7       6.0  

Risk-free interest rate

     4.2 %     4.2 %     4.8 %     4.8 %

Dividend yield

     0.0 %     0.0 %     0.0 %     0.0 %

Weighted average fair value of options granted during the period

   $ 0.08     $ 0.11     $ 0.53     $ 0.77  

 

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Table of Contents

NOVABAY PHARMACEUTICALS, INC.

(formerly NovaCal Pharmaceuticals, Inc.)

(a development stage company)

NOTES TO FINANCIAL STATEMENTS—(Continued)

 

Expected Price Volatility —This is a measure of the amount by which the stock price has fluctuated or is expected to fluctuate. Prior to the adoption of SFAS No. 123R, we assumed 0% price volatility in accordance with the minimum value method requirements of SFAS No. 123. In accordance with the fair value method of SFAS No. 123R, which we adopted on January 1, 2006, the computation of expected volatility for the year ended December 31, 2006 and for the three months ended March 31, 2007 was based on the historical volatility of comparable companies from a representative peer group selected based on industry and market capitalization data. An increase in the expected price volatility will increase the value of the option granted and the related compensation expense.

Expected Life —This is the period of time over which the options granted are expected to remain outstanding and is based on management’s estimate, taking into consideration vesting term, contractual term and historical actual lives. Options granted have a maximum term of ten years. An increase in the expected life will increase the value of the option granted and the related compensation expense.

Risk-Free Interest Rate —This is the U.S. Treasury rate for the week of the grant having a term approximating the expected life of the option. An increase in the risk-free interest rate will increase the value of the option granted and the related compensation expense.

Dividend Yield —We have not made any dividend payments nor do we have plans to pay dividends in the foreseeable future. An increase in the dividend yield will decrease the value of the option granted and the related compensation expense.

Under SFAS No. 123R, forfeitures are estimated at the time of grant and reduce compensation expense ratably over the vesting period. This estimate is adjusted periodically based on the extent to which actual forfeitures differ, or are expected to differ, from the previous estimate. For the year ended December 31, 2006 and the three months ended March 31, 2007, we applied an estimated forfeiture rate of 5% to employee grants and 0% to director grants. For the periods prior to January 1, 2006, we accounted for forfeitures as they occurred.

Stock-Based Compensation Expense

Upon the adoption of SFAS No. 123R on January 1, 2006, we began recognizing stock-based compensation expense in the statements of operations for all employee or director options granted or modified on or after January 1, 2006. Stock-based compensation expense is classified in the statements of operations in the same expense line items as cash compensation. No amounts were recognized for stock-based compensation paid to employees and directors in our statements of operations for any of the periods prior to January 1, 2006.

For the year ended December 31, 2006 and the three months ended March 31, 2006 and 2007, we recognized stock-based compensation expense of $313,000, $19,000 and $124,000, respectively. As of March 31, 2007, total unrecognized compensation cost related to unvested stock options granted or modified on or after January 1, 2006 was $562,000. This amount is expected to be recognized as stock-based compensation expense in our statements of operations over the remaining weighted average vesting period of 1.9 years.

Prior to the adoption of SFAS No. 123R, we valued our stock-based awards using the minimum value method and provided pro-forma information regarding stock-based compensation and net income required by SFAS No. 123. We did not recognize stock-based compensation expense in our statements of operations for option grants to our employees or directors for the periods prior to our adoption of SFAS No. 123R because the exercise price of options granted was generally equal to the fair market value of the underlying common stock on the date of grant. Under the prospective application method, we continue to account for non-vested equity awards

 

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NOVABAY PHARMACEUTICALS, INC.

(formerly NovaCal Pharmaceuticals, Inc.)

(a development stage company)

NOTES TO FINANCIAL STATEMENTS—(Continued)

 

outstanding at the date of adoption of SFAS No. 123R in the same manner as they had been accounted for prior to adoption. Pro forma disclosures for these awards are precluded.

NOTE 9. COLLABORATION AND LICENSE AGREEMENT

Alcon Manufacturing, Ltd.

In August 2006, we entered into a collaboration and license agreement with Alcon Manufacturing, Ltd. (“Alcon”) to license to Alcon the exclusive right to develop, manufacture and commercialize products incorporating the Aganocide compounds for application in connection with the eye, ear and sinus and for use in contact lens solutions. Under the terms of the agreement, Alcon agreed to pay an up-front, non-refundable technology access fee of $10.0 million upon the effective date of the agreement. Additionally, we will receive semi-annual payments to support on-going research and development activities over the four year funding term of the agreement. The research and development support payments include amounts to fund a specified number of personnel engaged in collaboration activities and to reimburse us for qualified equipment, materials and contract study costs. Our obligation to perform research and development activities under the agreement expires at the end of the four year funding term. As product candidates are developed and proceed through clinical trials and approval, we will receive milestone payments. If the products are commercialized, we will also receive royalties on any sales of products containing the Aganocide compound. Alcon has the right to terminate the agreement in its entirety upon nine months’ notice, or terminate portions of the agreement upon 135 days’ notice, subject to certain provisions. Both parties have the right to terminate the agreement for breach upon 60 days’ notice.

The up-front technology access fee was initially recorded as deferred revenue and is expected to be amortized into revenue on a straight-line basis over the four-year funding term of the agreement, through August 2010. During the quarter ended March 31, 2007, we received a payment of $1.4 million to support the performance of research and development activities from January 2007 through June 2007. At March 31, 2007, we had a deferred revenue balance of $675,000 related to the unearned portion of this payment. This amount will be recognized as revenue during the second quarter of 2007 when the associated research and development activities are performed. We also recognized $183,000 of revenue for materials, equipment and contract study costs incurred during the first quarter of 2007, which we expect to be reimbursed by Alcon. At March 31, 2007, this amount was recorded as a receivable and included in prepaid expenses and other current assets on our balance sheet. As of March 31, 2007, we had not earned or received any milestone or royalty payments under the Alcon agreement. In total, we recognized revenue of $1.5 million for both the year ended December 31, 2006 and the three months ended March 31, 2007 in connection with the Alcon agreement.

NOTE 10. EMPLOYEE BENEFIT PLAN

We have a 401(k) plan covering all eligible employees. We are not required to contribute to the plan and have made no contributions through March 31, 2007.

NOTE 11. INCOME TAXES

We have not recorded a provision for income taxes for any of the periods presented. The difference between the expected provision for income taxes, based on the United States federal statutory rate of 34%, from our actual provision for income taxes, an effective tax rate of 0%, is attributable to the net deferred tax assets offset by a full valuation allowance.

 

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NOVABAY PHARMACEUTICALS, INC.

(formerly NovaCal Pharmaceuticals, Inc.)

(a development stage company)

NOTES TO FINANCIAL STATEMENTS—(Continued)

 

The following table summarizes information about our provision for income taxes for the years ended December 31, 2004, 2005 and 2006.

 

     Year Ended December 31,  
     2004    2005    2006  
     (in thousands)  

Current taxes payable:

        

Federal

   $   —      $   —      $ —    

State

     —        —        —    
                      

Total current taxes payable

     —        —        —    
                      

Deferred taxes:

        

Federal

     —        —        461  

State

     —        —        79  
                      

Total deferred taxes

     —        —        540  
                      

Benefit of net operating loss:

        

Federal

     —        —        (461 )

State

     —        —        (79 )
                      

Total benefit of net operating loss

     —        —        (540 )
                      

Provision for income taxes

   $ —      $ —      $ —    
                      

Significant components of our deferred tax assets and liabilities as of December 31, 2005 and 2006 are as follows:

 

     December 31,  
     2005     2006  
     (in thousands)  

Deferred tax assets:

    

Net operating loss carryforwards

   $ 3,089     $ 2,550  

Deferred revenue

     —         2,655  

Accrued vacation

     29       22  

Contribution carryforwards

     —         12  
                

Total deferred tax assets

     3,118       5,239  
                

Deferred tax liabilities:

    

Depreciation

     20       30  
                

Total deferred tax liabilities

     20       30  
                

Net deferred tax assets

     3,098       5,209  

Less: valuation allowance

     (3,098 )     (5,209 )
                
   $ —       $ —    
                

The net change in the valuation allowance for the years ended December 31, 2005 and 2006 was an increase of $1.4 million and $2.1 million, respectively. We believe that sufficient uncertainty exists regarding the future realization of deferred tax assets. Accordingly, the net deferred tax assets have been fully offset by a valuation allowance.

 

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NOVABAY PHARMACEUTICALS, INC.

(formerly NovaCal Pharmaceuticals, Inc.)

(a development stage company)

NOTES TO FINANCIAL STATEMENTS—(Continued)

 

As of December 31, 2006 we had net operating loss and credit carryforwards for both federal and state income tax purposes of $6.4 million. If not utilized, the federal and state net operating loss and credit carryforwards will begin expiring at various dates between 2015 and 2025. Under the Tax Reform Act of 1986, as amended, the amounts of and benefits from net operating loss and credit carryforwards may be impaired or limited in certain circumstances. Events that could cause limitations in the amount of net operating losses that we may utilize in any one year include, but are not limited to, a cumulative ownership change of more than 50%, as defined, that may occur, for example, as a result of this offering aggregated with certain other sales of our stock before or after this offering.

NOTE 12. NET INCOME (LOSS) PER SHARE

The components of net income (loss) per share were as follows:

 

    

Year Ended

December 31,

    Three Months Ended
March 31,
 
       2004     2005     2006     2006     2007  
                       (unaudited)  
    

(in thousands, except per share data)

 

Net loss per share—basic and diluted:

          

Numerator:

          

Net loss

   $ (2,804 )   $ (3,463 )   $ (5,286 )   $ (1,218 )   $ (893 )
                                        

Denominator:

          

Weighted-average number of common shares outstanding during the period

     8,755       9,704       11,429       10,133       12,831  
                                        

Net loss per share—basic and diluted

   $ (0.32 )   $ (0.36 )   $ (0.46 )   $ (0.12 )   $ (0.07 )
                                        

Pro forma net loss per share—basic and diluted (unaudited):

          

Numerator:

          

Net loss

       $ (5,286 )     $ (893 )
                      

Denominator:

          

Weighted-average number of common shares outstanding during the period

         11,429         12,831  

Pro forma adjustments to reflect assumed weighted-average effect of conversion of preferred stock

         18,506         19,227  
                      

Shares used in pro forma per share calculation—basic and diluted

         29,935         32,058  
                      

Pro forma net loss per share—basic and diluted

       $ (0.18 )     $ (0.03 )
                      

 

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NOVABAY PHARMACEUTICALS, INC.

(formerly NovaCal Pharmaceuticals, Inc.)

(a development stage company)

NOTES TO FINANCIAL STATEMENTS—(Continued)

 

The following outstanding stock options, stock warrants and preferred stock were excluded from the diluted EPS computation as their effect would be anti-dilutive.

 

    

Year Ended

December 31,

  

Three Months Ended
March 31,

       2004    2005    2006    2006    2007
                    (unaudited)
     (in thousands)

Stock options

   3,286    3,565    4,791    3,999    4,932

Stock warrants

   3,486    2,656    —      2,603    —  

Convertible preferred stock

   16,391    17,488    19,227    17,623    19,227

Pro forma net loss per share for the year ended December 31, 2006 and the three months ended March 31, 2007 was computed using the weighted average number of shares of common stock outstanding, including the pro forma effects of the automatic conversion of the preferred stock into shares of common stock effective upon the closing of the offering as if such conversion occurred on the first day of the fiscal year, or at the date of the original issuance, if later.

NOTE 13. SUBSEQUENT EVENTS

Initial Public Offering

During October 2006, we engaged an underwriter to facilitate the sale of shares of common stock in an initial public offering (“IPO”). Upon the closing of the IPO, all shares of the Series A, Series B, Series C and Series D will automatically convert into shares of common stock at a 1-for-1 conversion ratio. Based on the number of outstanding shares as of March 31, 2007, if the IPO closes, all of the preferred stock outstanding will automatically convert into approximately 19.2 million shares of common stock.

Annual Meeting of Shareholders

On April 12, 2007, we held an annual meeting of shareholders at which our shareholders approved several proposals relating to the IPO. Among these proposals, the shareholders approved a reverse stock split within a range of 1-for-8 to 1-for-4, which reverse split will be effected prior to the completion of the IPO. Additionally, the shareholders approved our 2007 Omnibus Incentive Plan under which 4,000,000 shares (on a pre-reverse split basis) will be reserved for the issuance of stock options and other stock-based awards. This plan will become effective upon the closing of the IPO at which time no further awards would be granted under the 2005 Plan.

Equipment Loan

During April 2007, we entered into a Master Security Agreement to establish a $1.0 million equipment loan facility with General Electric Capital Corporation. The purpose of the loan is to finance equipment purchases, principally in the build-out of our laboratory facilities. Borrowings under the loan will be secured by eligible equipment purchased from January 2006 through April 2008 and will be repaid over forty months at an interest rate of 5.94% over the three year Treasury rate in effect at the time of funding. There are no loan covenants specified in the agreement.

On May 22, 2007, we borrowed $494,000 under the equipment loan facility. The principal and interest due under the loan will be repaid in equal monthly installments through September 2010 at an interest rate of 10.65%. As of the date of this prospectus, we had an outstanding loan balance of $479,000 under the facility.

 

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LOGO

 

 

 

 

 

 

Through and including                         , 2007 (the 25th day after the date of this prospectus), U.S. federal securities law may require all dealers that effect transactions in these securities, whether or not participating in this offering, to deliver a prospectus. This requirement is in addition to the dealers’ obligations to deliver a prospectus when acting as an underwriter and with respect to unsold allotments or subscriptions.


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Alternate Page for Canadian Prospectus

A copy of this preliminary prospectus has been filed with the securities regulatory authorities in each of British Columbia, Alberta, Manitoba and Ontario but has not yet become final for the purpose of the sale of securities. Information contained in this preliminary prospectus may not be complete and may have to be amended. The securities may not be sold until a receipt for the prospectus is obtained from the securities regulatory authorities.

No securities regulatory authority has expressed an opinion about these securities and it is an offence to claim otherwise.

This preliminary prospectus is a base PREP prospectus. This prospectus has been filed under procedures in British Columbia, Alberta, Manitoba and Ontario that permit certain information about these securities to be determined after the prospectus has become final and that permit the omission of that information from this prospectus. The procedures require the delivery to purchasers of a supplemented PREP prospectus containing the omitted information within a specified time after agreeing to purchase any of the securities. All disclosure contained in the supplemented PREP prospectus that is not contained in the base PREP prospectus will be incorporated by reference into the base PREP prospectus as of the date of the supplemented PREP prospectus.

This prospectus constitutes a public offering of these securities only in those jurisdictions where they may be lawfully offered for sale and therein only by persons permitted to sell these securities. NovaBay Pharmaceuticals, Inc. has filed a registration statement on Form S-1 with the United States Securities and Exchange Commission under the United States Securities Act of 1933, as amended, with respect to these securities. See “Underwriting”.

SECOND AMENDED AND RESTATED

PRELIMINARY BASE PREP PROSPECTUS

 

Initial Public Offering

   May 29, 2007

LOGO

NOVABAY PHARMACEUTICALS, INC.

U.S.$ ·

· Shares

This prospectus qualifies the distribution of shares of common stock of NovaBay Pharmaceuticals, Inc., the over-allotment option granted to the underwriters and the distribution of any shares of our common stock issuable upon exercise of the over-allotment option and the distribution of broker warrants granted to the underwriters. Unless otherwise noted, the terms “NovaBay”, “we”, “our” and “us” refer to NovaBay Pharmaceuticals, Inc. A total of · shares of common stock are being offered. We are offering our shares of common stock concurrently in Canada under the terms of this prospectus and in the United States under the terms of a registration statement on Form S-1. Our shares are being offered in Canada by an underwriting syndicate led by Dundee Securities Corporation and including · and in the United States by · . We anticipate that the public offering price will be between U.S.$ · and U.S.$ · per share. The offering price of the shares will be determined by negotiation between the representatives of the underwriters and us. In connection with the offering, the underwriters may over-allot or effect transactions that stabilize or maintain the market price of our common stock at levels other than those which otherwise might prevail on the open market. See “Underwriting”.

There is currently no market through which our common stock may be sold and purchasers may not be able to resell securities purchased under this prospectus. We have applied to list our common stock on the Toronto Stock Exchange (“TSX”) and the American Stock Exchange (“AMEX”) under the symbol “NBY”. Any such listings will be subject to the approval of the relevant stock exchanges and any such approvals will not be given unless all of the original listing requirements are satisfied. An investment in our common stock is subject to a number of risks that should be carefully considered by a prospective purchaser. Investors should carefully consider the risk factors described under “Risk Factors”.

 


Price: U.S.$ · per Share

 


 

    

Price to

the Public

   Underwriting discounts
and commissions (1)
   Net Proceeds (2)

Per Share

   U.S.$ ·    U.S.$ ·    U.S.$ ·

Total Offering (3)

   U.S.$ ·    U.S.$ ·    U.S.$ ·

 


Table of Contents

Alternate Page for Canadian Prospectus

Notes:

(1) The underwriting discounts and commissions represent the aggregate cash amount payable to the underwriters in connection with the offering. Discounts and commissions on the sale of shares to certain investors identified by us will be 0.7% rather than 7%, and to the extent such investors purchase shares in this offering the aggregate underwriting discounts and commissions will be reduced accordingly. See “Underwriting”. NovaBay has also granted to the underwriters broker warrants to purchase up to 7% of the total number of shares sold in this offering, including pursuant to the over-allotment option. This prospectus also qualifies the distribution of such warrants to the underwriters. See “Underwriting”.
(2) Before deducting the expenses of the offering estimated to be U.S.$ · , which expenses, together with the amount representing the underwriting discounts and commissions, will be paid out of the gross proceeds of the offering.
(3) We have granted to the underwriters an over-allotment option, exercisable until 30 days after the date of the closing of the offering, to purchase at the offering price additional shares of our common stock equal to up to 15% of the shares sold pursuant to the offering solely to cover over-allotments, if any, and for market stabilization purposes. If the over-allotment option is exercised in full, the total “Price to the Public”, “Underwriting discounts and commissions” and “Net Proceeds” will be U.S.$ · , U.S.$ · and U.S.$ · , respectively. This prospectus also qualifies the distribution of the over-allotment option and the distribution of any shares of our common stock issuable upon exercise of the over-allotment option. See “Underwriting”.

 

Underwriters’ Position

   Maximum size    Exercise period    Exercise price

Over-allotment option

   ·    30 days from the
date of the closing
   U.S.$ ·

Broker warrants

   ·    24 months from
the one year
anniversary of the
date of the closing
   U.S.$ ·

NovaBay Pharmaceuticals, Inc. is incorporated under the laws of a foreign jurisdiction and resides outside of Canada. Although we have appointed FMD Service (Ontario) Inc., Toronto Dominion Tower, Toronto-Dominion Centre, 66 Wellington Street West, Suite 4200, Toronto, Ontario, M5K 1N6, as our agent for service of process in Ontario, it may not be possible for investors to collect from us judgments obtained in courts of Canada predicated on the civil liability provisions of applicable securities laws of Canada.

The underwriters, as principals, conditionally offer shares of our common stock, subject to prior sale, if, as and when issued and sold by us, and delivered to and accepted by the underwriters in accordance with the conditions contained in the underwriting agreement referred to under “Underwriting” and subject to the approval of certain legal matters on behalf of us by Fasken Martineau DuMoulin LLP, as to matters of Canadian law, and Dorsey & Whitney LLP, as to matters of United States law, and on behalf of the underwriters by Blake, Cassels & Graydon LLP, as to matters of Canadian law, and Skadden, Arps, Slate, Meagher & Flom LLP, as to matters of United States law. The underwriters may, in certain circumstances, offer the common stock at a lower price than stated above. See “Underwriting”.

Subscriptions for shares of our common stock will be received subject to rejection or allotment in whole or in part and the right is reserved to close the subscription books at any time without notice. It is expected that the closing of the offering will take place on · , 2007 or such other date as NovaBay and the underwriters may agree, but no later than · , 2007, and that certificates representing shares of our common stock will be issued on the date of the closing of the offering. See “Underwriting”.


Table of Contents

Alternate Page for Canadian Prospectus

 

TABLE OF CONTENTS

 

     Page

NOTICE TO CANADIAN INVESTORS REGARDING GAAP

   i

ENFORCEMENT OF LEGAL RIGHTS

   i

ELIGIBILITY FOR INVESTMENT

   i

PROSPECTUS SUMMARY

   1

RISK FACTORS

   8

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

   27

USE OF PROCEEDS

   28

DIVIDEND POLICY

   28

CAPITALIZATION

   29

DILUTION

   30

SELECTED FINANCIAL DATA

   32

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

   34

BUSINESS

   49

MANAGEMENT

   82

RELATED PARTY TRANSACTIONS

   98

PRINCIPAL SHAREHOLDERS

   99

DESCRIPTION OF CAPITAL STOCK

   101

PRIOR SALES OF SHARES

   104

SHARES ELIGIBLE FOR FUTURE SALE

   105

MATERIAL U.S. FEDERAL INCOME AND ESTATE TAX CONSIDERATIONS TO NON-U.S. HOLDERS

   109

MATERIAL CANADIAN FEDERAL INCOME TAX CONSIDERATIONS

   112

UNDERWRITING

   115

NOTICE TO INVESTORS

   119

LEGAL MATTERS

   120

EXPERTS

   120

WHERE YOU CAN FIND MORE INFORMATION

   121

MATERIAL CONTRACTS

   122

STATUTORY RIGHTS OF WITHDRAWAL AND RESCISSION

   122

AUDITORS’ CONSENT

   123

INDEX TO FINANCIAL STATEMENTS

   F-1

CERTIFICATE OF THE COMPANY

   C-1

CERTIFICATE OF THE CANADIAN UNDERWRITERS

   C-2

 


You should rely only on the information contained in this prospectus. We have not, and the underwriters have not, authorized any other person to provide you with additional or different information. If anyone provides you different or inconsistent information, you should not rely on it. We and the underwriters are offering to sell and seeking offers to buy shares of our common stock only in jurisdictions where offers or sales are permitted. The information in this prospectus is only accurate as of the date of this prospectus, regardless of the time of delivery of this prospectus or of any sale of our common stock. Our business, financial condition, results of operations and prospects may have changed since the date of this prospectus.


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Alternate Page for Canadian Prospectus

NOTICE TO CANADIAN INVESTORS REGARDING GAAP

Our financial statements included in this prospectus have been prepared in accordance with United States generally accepted accounting principles, or U.S. GAAP, which differ in certain respects from Canadian generally accepted accounting principles, or Canadian GAAP. We have been advised by such Canadian provincial securities commissions that exemptive relief, permitting us to include financial statements in this preliminary prospectus as it may be amended from time to time, and in our final prospectus and any supplemented prospectus, which are prepared in accordance with U.S. GAAP only, will be granted and will be evidenced by the final Mutual Reliance Review System decision document issued in respect of our prospectus. We therefore, have not provided, and, assuming that the relief for which we have applied is granted, we will not be required to provide, a reconciliation of our financial statements to Canadian GAAP.

ENFORCEMENT OF LEGAL RIGHTS

We are organized under the laws of the State of California and, accordingly, the rights and remedies generally available to shareholders under Canadian corporate law will not be available to investors. In addition, certain of our officers and directors reside outside of Canada. Furthermore, substantially all of our assets and the assets of our officers and directors are located outside of Canada. Although we have appointed FMD Service (Ontario) Inc., Toronto Dominion Tower, Toronto-Dominion Centre, 66 Wellington Street West, Suite 4200, Toronto, Ontario, M5K 1N6 as our agent for service of process within Ontario, it may not be possible for investors to effect service of process within Canada upon our directors or officers. In addition, it may not be possible to enforce against us or our directors or officers judgments obtained in courts in Canada predicated on the civil liability provisions of applicable securities laws of Canada.

ELIGIBILITY FOR INVESTMENT

On the date of this prospectus, the shares of our common stock if, as and when listed on a prescribed stock exchange as defined in the regulations to the Income Tax Act (Canada), which currently includes the TSX and AMEX, would, if issued on the date hereof, be qualified investments under the Income Tax Act (Canada) and the regulations thereunder for trusts governed by registered retirement savings plans, registered retirement income funds, deferred profit sharing plans and registered education savings plans.

 

i


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WHERE YOU CAN FIND MORE INFORMATION

In connection with this offering, we are and will be subject to the informational requirements of the securities commissions in the provinces of Canada in which shares of our common stock are being offered pursuant hereto. In this respect, we intend to file certain reports, statements or other information with such Canadian provincial securities commissions. These filings, other than confidential filings, will be electronically available from the System for Electronic Document Analysis and Retrieval (SEDAR) ( http://www.sedar.com ). For further information with respect to us and our common stock, please see the reports, statements or other information filed pursuant to such informational requirements. Statements contained in this prospectus regarding the contents of any contract or any other document that is filed pursuant to such informational requirements are not necessarily complete, and each such statement is qualified in all respects by reference to the full text of such contract or other document filed with the applicable Canadian provincial securities commissions.

We have filed a registration statement on Form S-1 with the SEC under the Securities Act with respect to this offering. The registration statement, including its exhibits and schedules, may be inspected without charge at the public reference room maintained by the SEC, located at 100 F Street, N.E., Room 1580, Washington, D.C. 20549, and copies of all or any part of the registration statement may be obtained from such offices upon the payment of the fees prescribed by the SEC. Please call the SEC at 1-800-SEC-0330 for further information about the public reference room. The SEC also maintains an Internet website that contains reports, proxy and information statements and other information regarding registrants that file electronically with the SEC. The address of the site is www.sec.gov .

Upon completion of this offering, we will also become subject to the information and periodic reporting requirements of the Exchange Act, and, in accordance therewith, will file periodic reports, proxy statements and other information with the SEC. Such periodic reports, proxy statements and other information will be available for inspection and copying at the public reference room and on the SEC website referred to above.

Upon the filing of a final prospectus with the applicable Canadian provincial securities commissions, we will become a reporting issuer under the securities laws of those jurisdictions that provide for a reporting issuer regime. We are generally exempt from the requirements of the laws of such jurisdictions relating to continuous disclosure and proxy solicitation. Our insiders may also, in certain circumstances, be exempt from Canadian insider reporting requirements. Such exemptions generally permit us to comply with certain informational requirements applicable in the U.S. instead of the continuous disclosure requirements normally applicable in such Canadian jurisdictions, provided that the relevant documents are filed with such Canadian provincial securities commissions and are provided to security holders in Canada to the extent and in the manner and within the time required by applicable U.S. requirements. These filings will be electronically available from SEDAR.

 

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MATERIAL CONTRACTS

The following are the material contracts of NovaBay, other than contracts entered into in the ordinary course of business that were entered into within the two years before the date of this prospectus or which will be entered into at or prior to the closing of the offering:

 

   

Underwriting Agreement dated as of                     , 2007 among us and the underwriters;

 

   

Collaboration and License Agreement dated August 29, 2006 by and between us and Alcon Manufacturing, Ltd.;

 

   

Lock-up Agreement dated as of                         , 2007 by and between the underwriters and Ramin (“Ron”) Najafi, Ph.D.;

 

   

Lock-up Agreements dated as of                         , 2007 by and between the underwriters and each of our other officers and directors;

 

   

Master Security Agreement dated April 23, 2007 by and between us and General Electric Capital Corporation;

 

   

Office Lease dated June 3, 2004 (as amended) by and between us and Emery Station Associates II, LLC; and

 

   

Financial Advisory and Investor Relations Consulting Agreement dated February 14, 2007 by and between us and PM Holdings Ltd.

The material contracts described above, once entered into, and any other documents regarding NovaBay referred to in this prospectus, may be inspected at the offices of NovaBay’s Canadian counsel, Fasken Martineau DuMoulin LLP, Suite 4200, 66 Wellington Street West, Toronto, Ontario, M5K 1N6 during normal business hours during the period of the distribution of the securities hereunder, or they may be viewed on the Internet at www.sedar.com .

STATUTORY RIGHTS OF WITHDRAWAL AND RESCISSION

Securities legislation in certain of the provinces of Canada provides purchasers with the right to withdraw from an agreement to purchase securities. This right may be exercised within two business days after receipt, or deemed receipt, of a prospectus and any amendment thereto. In several of the provinces, the securities legislation further provides a purchaser with remedies for rescission or, in some provinces, damages if the prospectus and any amendment contains a misrepresentation or is not delivered to the purchaser, provided that the remedies for rescission or damages are exercised by the purchaser within the time limit prescribed by the securities legislation of the purchaser’s province. The purchaser should refer to any applicable provisions of the securities legislation of the purchaser’s province for the particulars of these rights or consult with a legal adviser.

 

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Alternate Page for Canadian Prospectus

 

AUDITORS’ CONSENT

We have read the amended and restated preliminary base PREP prospectus of NovaBay Pharmaceuticals, Inc. (the “Company”) (formerly NovaCal Pharmaceuticals, Inc.) dated May 29, 2007 relating to the new issue and sale of common shares of the Company. We have complied with the generally accepted standards of the Public Company Accounting Oversight Board (United States) for an auditor’s involvement with offering documents.

We consent to the use in the above mentioned prospectus of our report to the board of directors and the stockholders of the Company on the balance sheets of the Company as at December 31, 2006 and 2005 and the statements of operations, cash flows, and stockholders’ equity for the years ended December 31, 2006, 2005 and 2004. Our report is dated February 15, 2007 (except as to Note 13 which is as of May 29, 2007).

/s/ Davidson & Company LLP

Chartered Accountants

Vancouver, Canada

May 29, 2007

 

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Alternate Page for Canadian Prospectus

CERTIFICATE OF THE COMPANY

Dated: May 29, 2007

This prospectus, together with the documents and information incorporated herein by reference, will, as of the date of the supplemented prospectus providing the information permitted to be omitted from this prospectus, constitute full, true and plain disclosure of all material facts relating to the securities offered by this prospectus as required under securities legislation of British Columbia, Alberta, Manitoba and Ontario.

NOVABAY PHARMACEUTICALS, INC.

 

  By: (Signed) Ramin (“Ron”) Najafi       By: (Signed) John (“Jack”) O’Reilly
 

President and Chief Executive Officer

     

Chief Financial Officer

On behalf of the Board of Directors of NovaBay Pharmaceuticals, Inc.

 

  By: (Signed) Paul E. Freiman       By: (Signed) Robert R. Tufts
 

Director

     

Director

 

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Alternate Page for Canadian Prospectus

CERTIFICATE OF THE CANADIAN UNDERWRITERS

Dated: May 29, 2007

To the best of our knowledge, information and belief, this prospectus, together with the documents incorporated herein by reference, will, as of the date of the supplemented prospectus providing the information permitted to be omitted from this prospectus, constitute full, true and plain disclosure of all material facts relating to the securities offered by this prospectus as required under securities legislation of British Columbia, Alberta, Manitoba and Ontario.

DUNDEE SECURITIES CORPORATION

By: (Signed) Jolyon Burton

 

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PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

Item 13. Other Expenses of Issuance and Distribution

The following table sets forth the costs and expenses, other than underwriting discounts and commissions, payable in connection with the sale and distribution of the securities being registered. All amounts are estimated except the SEC registration and the National Association of Securities Dealers, Inc. (“NASD”) filing fees. All of the expenses below will be paid by us.

 

Item

    

SEC registration fee

   $ 2,461

NASD filing fee

     2,800

American Stock Exchange listing fee

  

Toronto Stock Exchange listing fee

  

Blue sky fees and expenses

  

Printing and engraving expenses

  

Legal fees and expenses

  

Accounting fees and expenses

  

Transfer agent and registrar fees

  

Miscellaneous

  
      

Total

   $             
      

Item 14. Indemnification of Directors and Officers.

Section 317 of the California Corporations Code authorizes a court to award, or a corporation’s Board of Directors to grant, indemnity to directors and officers who are parties or are threatened to be made parties to any proceeding (with certain exceptions) by reason of the fact that the person is or was an agent of the corporation, against expenses, judgments, fines, settlements and other amounts actually and reasonably incurred in connection with the proceeding if that person acted in good faith and in a manner the person reasonably believed to be in the best interests of the corporation. Section 204 of the California Corporations Code provides that this limitation on liability has no effect on a director’s liability (a) for acts or omissions that involve intentional misconduct or a knowing and culpable violation of law, (b) for acts or omissions that a director believes to be contrary to the best interests of the corporation or its shareholders or that involve the absence of good faith on the part of the director, (c) for any transaction from which a director derived an improper personal benefit, (d) for acts or omissions that show a reckless disregard for the director’s duty to the corporation or its shareholders in circumstances in which the director was aware, or should have been aware, in the ordinary course of performing a director’s duties, of a risk of a serious injury to the corporation or its shareholders, (e) for acts or omissions that constitute an unexcused pattern of inattention that amounts to an abdication of the director’s duty to the corporation or its shareholders, (f) under Section 310 of the law (concerning contracts or transactions between the corporation and a director), or (g) under Section 316 of the law (directors’ liability for improper dividends, loans and guarantees). Section 317 does not extend to acts or omissions of a director in his capacity as an officer. Further, Section 317 has no effect on claims arising under federal or state securities laws and does not affect the availability of injunctions and other equitable remedies available to our shareholders for any violation of a director’s fiduciary duty to us or our shareholders. Although the validity and scope of the legislation underlying Section 317 have not yet been interpreted to any significant extent by the California courts, Section 317 may relieve directors of monetary liability to us for grossly negligent conduct, including conduct in situations involving attempted takeovers of our company.

In accordance with Section 317, our articles of incorporation eliminate the liability of each of our directors for monetary damages to the fullest extent permissible under California law. Our articles of incorporation further

 

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authorize us to provide indemnification to our agents (including our officers and directors), subject to the limitations set forth above. The articles of incorporation and our amended and restated bylaws further provide for indemnification of our officers and directors to the maximum extent permitted by California law, and also permit the indemnification of other corporate agents to the maximum extent permitted by California law at the discretion of our Board of Directors. Additionally, we maintain insurance policies which insure our officers and directors against certain liabilities.

The foregoing summaries are necessarily subject to the complete text of the California Corporations Code, our articles of incorporation, our amended and restated bylaws and the agreements referred to above and are qualified in their entirety by reference thereto.

We have entered into agreements to indemnify our directors and certain of our officers in addition to the indemnification provided for in the articles of incorporation and amended and restated bylaws. These agreements will, among other things, indemnify our directors and some of our officers for certain expenses (including attorneys fees), judgments, fines and settlement amounts incurred by such person in any action or proceeding, including any action by or in our right, on account of services by that person as a director or officer of NovaBay or as a director or officer of any of our subsidiaries, or as a director or officer of any other company or enterprise that the person provides services to at our request.

Lastly, the underwriting agreement (Exhibit 1.1 to this registration statement) provides for indemnification by the underwriters of us and our officers and directors, and by us of the underwriters, for certain liabilities arising under the Securities Act of 1933, as amended (the “Securities Act”) or otherwise in connection with this offering.

Item 15. Recent Sales of Unregistered Securities

The following is a summary of our transactions since December 31, 2003, involving sales of our securities that were not registered under the Securities Act:

Common Stock Issuances

(1) In April 2004, we issued an aggregate of 764,977 shares of our common stock to various individuals as compensation for services rendered to us, which included services in connection with a private placement of Series B Preferred Stock.

(2) From March 2005 to November 2005, we issued an aggregate of 369,372 shares of our common stock to various individuals as compensation for services rendered to us, which included services in connection with a private placement of our Series C Preferred Stock.

(3) From June 2006 to December 2006, we issued an aggregate of 66,754 shares of our common stock to various individuals as compensation for services rendered to us, which included services in connection with a private placement of our Series D Preferred Stock.

(4) In February 2007, we issued an aggregate of 70,000 shares of common stock to one of our consultants as compensation for services rendered to us.

(5) From April 2004 to December 2004, we sold and issued an aggregate of 62,500 shares of common stock at purchase prices ranging from $0.40 per share to $0.60 per share upon the exercise of warrants.

(6) From March 2005 to September 2005, we sold and issued an aggregate of 583,988 shares of common stock at purchase prices ranging from $0.40 per share to $0.60 per share upon the exercise of warrants.

 

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(7) From January 2006 to June 2006, we sold and issued an aggregate of 2,297,169 shares of common stock at purchase prices ranging from $0.40 per share to $0.60 per share upon the exercise of warrants.

Preferred Stock Issuances

(8) From January 2004 to March 2004, we sold and issued an aggregate of 2,693,766 shares of Series B Preferred Stock at a purchase price of $0.47 per share in connection with a private placement. In January of 2004, we issued an additional 912,850 shares of Series B Preferred Stock at $0.47 per share upon conversion of outstanding convertible promissory notes.

(9) From May 2004 to October 2005, we sold and issued an aggregate of 6,666,659 shares of Series C Preferred Stock at a purchase price of $0.85 per share in connection with a private placement.

(10) From June 2005 to September 2006, we sold and issued an aggregate of 2,481,094 shares of Series D Preferred Stock at a purchase price of $1.50 per share in connection with a private placement.

Warrant Issuances

(11) From January 2004 to March 2004, we issued warrants to purchase up to an aggregate of 1,806,576 shares of our common stock at an exercise price of $0.40 per share to certain holders of our Series B Preferred Stock. In January 2005, we issued a warrant to purchase up to an aggregate of 4,840 shares of our common stock at an exercise price of $0.40 per share to one of our holders of Series B Preferred Stock. As of February 14, 2007, there were no warrants outstanding to purchase any shares of our capital stock.

Stock Option Issuances

(12) From January 2004 to December 2004, we issued options to certain of our employees, directors and consultants to acquire up to an aggregate of 1,270,500 shares of our common stock under our 2002 Stock Option Plan (the “2002 Plan”) at prices ranging from $0.15 per share to $0.28 per share. From January 2005 to October 2005, we issued options to certain of our employees, directors and consultants to acquire up to an aggregate of 330,000 shares of our common stock under our 2002 Plan at exercise prices ranging from $0.28 per share to $0.60 per share. As of March 31, 2007, 2,564,716 shares of our common stock were issuable upon exercise of outstanding options granted under the 2002 Plan.

(13) In May 2005, we issued options to certain of our consultants to acquire up to an aggregate of 46,000 shares of our common stock under our 2005 Stock Option Plan (the “2005 Plan”) at exercise prices ranging from $0.28 per share to $0.60 per share. From January 2006 to September 2006, we issued options to certain of our employees and consultants to acquire up to an aggregate of 1,644,000 shares of our common stock under our 2005 Plan at exercise prices ranging from $0.60 per share to $1.00 per share. In January 2007, we issued options to certain of our employees and consultants to acquire up to an aggregate of 441,250 shares of our common stock under our 2005 Plan at an exercise price of $1.14 per share. As of March 31, 2007, 2,045,250 shares of our common stock were issuable upon exercise of outstanding options granted under the 2005 plan.

(14) In March 2005 and January 2007, we issued options to various individuals to acquire up to an aggregate of 561,958 shares of our common stock outside of our 2002 Plan and 2005 Plan at prices ranging from $0.47 per share to $1.14 per share as compensation for services rendered to us in connection with a private placement of our preferred stock. As of March 31, 2007, 311,958 shares of our common stock were issuable upon exercise of outstanding options granted outside of our 2002 Plan and 2005 Plan.

The issuances of securities in the transactions described in paragraphs 1 through 3, 5 through 11, and 14 above were effected without registration under the Securities Act in reliance on Section 4(2) thereof or Rule 506 of Regulation D thereunder based on the status of each investor as an accredited investor as defined under the Securities Act. The issuances of securities in the transactions described in paragraphs 12 and 13 above were effected without registration under the Securities Act in reliance on Section 4(2) thereof or Rule 701 thereunder as transactions pursuant to compensatory benefit plans and contracts relating to compensation. None of the

 

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foregoing transactions was effected using any form of general advertising or general solicitation as such terms are used in Regulation D under the Securities Act. The recipients of securities in each such transaction either received adequate information about us or had access, through their relationships with us, to such information.

The issuances of securities in the transaction described in paragraph 4 above were effected without registration under the Securities Act in reliance on Rule 903 of Regulation S thereunder as an offer and sale of securities that occurred outside the United States. The sale of securities was made in an offshore transaction, did not involve any directed selling efforts within the United States, and involved only purchasers who were outside the United States and were non-U.S. Persons. In addition, such securities were also exempt from registration under the Securities Act in reliance on Section 4(2) thereof and Rule 506 of Regulation D thereunder based on the status of such investor as an accredited investor as defined under the Securities Act.

Item 16. Exhibits and Financial Statement Schedules

(a) Exhibits

 

Exhibit No.   

Description

      1.1*    Form of Underwriting Agreement
      3.1**    Articles of Incorporation of the Registrant, as amended
      3.2    Proposed Amended and Restated Articles of Incorporation of the Registrant to be effective upon completion of this offering
      3.3**    Bylaws of the Registrant, as amended
      3.4    Proposed Amended and Restated Bylaws of the Registrant to be effective upon the completion of this offering
      4.1*    Specimen common stock certificate
      5.1*    Opinion of Dorsey & Whitney LLP
    10.1+**    2002 Stock Option Plan, and forms of agreements thereto
    10.2+**    2005 Stock Option Plan, and forms of agreements thereto
    10.3+    2007 Omnibus Incentive Plan, and forms of agreements thereto
    10.4+*    Employment Agreement dated                  2007 by and between the Registrant and Ramin (“Ron”) Najafi
    10.5+*    Employment Agreement dated                  2007 by and between the Registrant and John (“Jack”) O’Reilly
    10.6+*    Employment Agreement dated                  2007 by and between the Registrant Behzad Khosrovi
    10.7+*    Employment Agreement dated                  2007 by and between the Registrant and Colin Scott
    10.8+**    Stock Option Grant dated May 23, 2002 by and between the Registrant and John (“Jack”) O’Reilly
    10.9+**    Stock Option Grant dated January 30, 2004 by and between the Registrant and Behzad Khosrovi
    10.10**    Office Lease dated June 3, 2004 by and between the Registrant and Emery Station Associates II, LLC, as amended
    10.11†    Collaboration and License Agreement dated August 29, 2006 by and between the Registrant and Alcon Manufacturing, Ltd.
    10.12**    Financial Advisory and Investor Relations Consulting Agreement dated February 14, 2007 by and between the Registrant and PM Holdings Ltd.
    10.13    Director Compensation Plan
    10.14    Master Security Agreement dated April 23, 2007 by and between the Registrant and General Electric Capital Corporation

 

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Exhibit No.   

Description

    23.1    Consent of Davidson & Company LLP
    23.2*    Consent of Dorsey & Whitney LLP (included in Exhibit 5.1)
    24.1**    Power of Attorney

* To be filed by amendment.
** Previously filed.
Confidential treatment is requested for certain confidential portions of this exhibit pursuant to Rule 406 under the Securities Act. In accordance with Rule 406, these confidential portions have been omitted from this exhibit and filed separately with the Commission.
+ Indicates management contract or compensatory plan.

(b) Financial Statement Schedules

Schedules have been omitted because the information required to be set forth therein is not applicable or is shown in the financial statements or notes thereto.

Item 17. Undertakings

The registrant hereby undertakes to provide to the Underwriters at the closing specified in the underwriting agreement certificates in such denominations and registered in such names as required by the Underwriters to permit prompt delivery to each purchaser.

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of NovaBay pursuant to the foregoing provisions, or otherwise, NovaBay has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by NovaBay of expenses incurred or paid by a director, officer or controlling person of NovaBay in the successful defense of any action, suit, or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, NovaBay will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

The undersigned registrant hereby undertakes that:

(1) For purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus as filed as part of this Registration Statement in reliance upon Rule 430A and contained in a form of prospectus filed by NovaBay pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this Registration Statement as of the time it was declared effective.

(2) For the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and this offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

 

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SIGNATURES

Pursuant to the requirements of the Securities Act of 1933, as amended, NovaBay Pharmaceuticals, Inc. has duly caused this Amendment No. 3 to the Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Emeryville, State of California, on the 29th day of May 2007.

 

NovaBay Pharmaceuticals, Inc.
By:  

/ S /    R AMIN N AJAFI        

 

Ramin (“Ron”) Najafi

Chairman of the Board, Chief Executive Officer

and President

Pursuant to the requirements of the Securities Act of 1933, as amended, this Amendment No. 3 to the Registration Statement on Form S-1 has been signed by the following persons in the capacities and on the dates indicated:

 

Signature

  

Title

 

Date

/s/    R AMIN N AJAFI        

Ramin (“Ron”) Najafi

   Chairman of the Board, Chief Executive Officer and President (principal executive officer)   May 29, 2007

/s/    J ACK O’R EILLY        

John (“Jack”) O’Reilly

   Senior Vice President, Corporate Development, Chief Financial Officer, Treasurer and Director (principal financial and accounting officer)   May 29, 2007

*

Charles J. Cashion

   Director   May 29, 2007

*

Anthony Dailley, DDS

   Director   May 29, 2007

*

Paul E. Freiman

   Director   May 29, 2007

*

Alex McPherson, MD, Ph.D.

   Director   May 29, 2007

*

Robert R. Tufts

   Director   May 29, 2007

*

Tony Wicks

   Director   May 29, 2007
*By:   /s/    R AMIN N AJAFI        
 

Ramin (“Ron”) Najafi

Attorney-in-Fact

 

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EXHIBIT INDEX

 

Exhibit No.   

Description

      1.1*    Form of Underwriting Agreement
      3.1**    Articles of Incorporation of the Registrant, as amended
      3.2    Proposed Amended and Restated Articles of Incorporation of the Registrant to be effective upon completion of this offering
      3.3**    Bylaws of the Registrant, as amended
      3.4    Proposed Amended and Restated Bylaws of the Registrant to be effective upon the completion of this offering
      4.1*    Specimen common stock certificate
      5.1*    Opinion of Dorsey & Whitney LLP
    10.1+**    2002 Stock Option Plan, and forms of agreements thereto
    10.2+**    2005 Stock Option Plan, and forms of agreements thereto
    10.3+    2007 Omnibus Incentive Plan, and forms of agreements thereto
    10.4+*    Employment Agreement dated                  2007 by and between the Registrant and Ramin (“Ron”) Najafi
    10.5+*    Employment Agreement dated                  2007 by and between the Registrant and John (“Jack”) O’Reilly
    10.6+*    Employment Agreement dated                  2007 by and between the Registrant Behzad Khosrovi
    10.7+*    Employment Agreement dated                  2007 by and between the Registrant and Colin Scott
    10.8+**    Stock Option Grant dated May 23, 2002 by and between the Registrant and John (“Jack”) O’Reilly
    10.9+**    Stock Option Grant dated January 30, 2004 by and between the Registrant and Behzad Khosrovi
    10.10**    Office Lease dated June 3, 2004 by and between the Registrant and Emery Station Associates II, LLC, as amended.
    10.11†    Collaboration and License Agreement dated August 29, 2006 by and between the Registrant and Alcon Manufacturing, Ltd.
    10.12**    Financial Advisory and Investor Relations Consulting Agreement dated February 14, 2007 by and between the Registrant and PM Holdings Ltd.
    10.13    Director Compensation Plan
    10.14    Master Security Agreement dated April 23, 2007 by and between the Registrant and General Electric Capital Corporation
    23.1    Consent of Davidson & Company LLP
    23.2*    Consent of Dorsey & Whitney LLP (included in Exhibit 5.1)
    24.1**    Power of Attorney

* To be filed by amendment.
** Previously filed
Confidential treatment is requested for certain confidential portions of this exhibit pursuant to Rule 406 under the Securities Act. In accordance with Rule 406, these confidential portions have been omitted from this exhibit and filed separately with the Commission.
+ Indicates management contract or compensatory plan.

Exhibit 3.2

AMENDED AND RESTATED

ARTICLES OF INCORPORATION OF

NOVABAY PHARMACEUTICALS, INC.

Ramin Najafi and Robert R. Tufts hereby certify as follows:

1. They are the President and Secretary, respectively, of NovaBay Pharmaceuticals, Inc., a California corporation.

2. The Amended and Restated Articles of Incorporation of said corporation, as amended, are hereby amended and restated in their entirety to read as follows:

ARTICLE 1.

The name of this corporation (“ Corporation ”) is NovaBay Pharmaceuticals, Inc.

ARTICLE 2.

The purpose of this Corporation is to engage in any lawful act or activity for which a corporation may be organized under the General Corporation Law of California, other than the banking business, the trust company business or the practice of a profession permitted to be incorporated by the California Corporations Code.

ARTICLE 3.

This Corporation is authorized to issue two classes of stock, designated “Preferred Stock” and “Common Stock,” respectively. The total number of shares which this Corporation shall have authority to issue is Seventy-Million (70,000,000), having a par value of $0.01 per share. The number of shares of Common Stock authorized to be issued is Sixty-Five Million (65,000,000) shares, having a par value of $0.01 per share. The number of shares of Preferred Stock authorized to be issued is Five Million (5,000,000), having a par value of $0.01 per share.

A. The holders of shares of the Common Stock shall be entitled to vote on all matters to be voted on by the shareholders of the Corporation and shall be entitled to one vote for each share thereof held of record.

B. The Preferred Stock may be issued from time to time by the board of directors as shares of one or more series, without further shareholder approval. Subject to the provisions hereof and the limitations prescribed by law, the board of directors is expressly authorized, by adopting resolutions providing for the issuance of shares of any particular series and, if and to the extent from time to time required by law, by filing with the California Secretary of State a certificate setting forth the resolutions so adopted pursuant to the General Corporation Law of California, to establish the number of shares to be included in each such series and to fix the

 

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designation and relative powers, including voting powers, preferences, rights, qualifications and limitations and restrictions thereof, relating to the shares of each such series. The rights, privileges, preferences and restrictions of any such additional series may be subordinated to, pari passu with (including, without limitation, inclusion in provisions with respect to liquidation and acquisition preferences, redemption and/or approval of matters by vote), or senior to any of those of any present or future class or series of Preferred Stock or Common Stock. The board of directors is also authorized to increase or decrease the number of shares of any series prior or subsequent to the issue of that series, but not below the number of shares of such series then outstanding. In case the number of shares of any series shall be so decreased, the shares constituting such decrease shall resume the status which they had prior to the adoption of the resolution originally fixing the number of shares of such series.

The authority of the board of directors with respect to each series shall include, but not be limited to, determination of the following:

(i) the distinctive serial designation of such series and the number of shares constituting such series;

(ii) the annual dividend rate on shares of such series, if any, whether dividends shall be cumulative and, if so, from which date or dates;

(iii) whether the shares of such series shall be redeemable and, if so, the terms and conditions of such redemption, including the date or dates upon and after which such shares shall be redeemable, and the amount per share payable in case of redemption, which amount may vary under different conditions and at different redemption dates;

(iv) the obligation, if any, of the Corporation to retire shares of such series pursuant to a sinking fund;

(v) whether shares of such series shall be convertible into, or exchangeable for, shares of stock of any other class or classes and, if so, the terms and conditions of such conversion or exchange, including the price or prices or the rate or rates of conversion or exchange and the terms of adjustment, if any;

(vi) whether the shares of such series shall have voting rights, in addition to any voting rights provided by law, and, if so, the terms of such voting rights;

(vii) the rights of the shares of such series in the event of voluntary or involuntary liquidation, dissolution or winding-up of the Corporation; and

(viii) any other relative rights, powers, preferences, qualifications, limitations or restrictions thereof relating to such series

ARTICLE 4.

The number of directors to constitute the whole board of directors shall not be less than six (6) nor more than eleven (11), and the exact number of directors shall be fixed within these specified limits by the board of directors in the manner provided in the bylaws. The board of

 

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directors shall be divided into three classes as nearly equal in number as may be feasible, hereby designated as Class I, Class II and Class III, with the term of office of one class expiring each year. For the purposes hereof, the initial Class I, Class II and Class III directors shall be those directors so designated and elected and who are holding such offices as of the date these Amended and Restated Articles of Incorporation are duly filed with the Secretary of State of the State of California. At the annual meeting of shareholders in 2008, the term of office of the Class I directors shall expire and Class I directors shall be elected for a full term of three years. At the annual meeting of shareholders in 2009, the term of office of the Class II directors shall expire and Class II directors shall be elected for a full term of three years. At the annual meeting of shareholders in 2010, the term of office of the Class III directors shall expire and Class III directors shall be elected for a full term of three years. At each succeeding annual meeting of shareholders, successors to the directors whose terms shall then expire shall be elected to hold office for terms expiring at the third succeeding annual meeting of shareholders. In case of any vacancies, by reason of an increase in the number of directors, removal by the shareholders or otherwise, subject to the rights of the holders of any series of Preferred Stock then outstanding, each additional director may be elected by a majority of the directors then in office, even though less than a quorum of the board of directors, to serve until the end of the term he or she is elected to fill and until his or her successor shall have been elected and qualified in the class to which such director is assigned and for the term or remainder of the term of such class. Directors shall continue in office until others are elected and qualified in their stead. When the number of directors is changed, each director then serving as such shall nevertheless continue as a director of the class of which he or she is a member until the expiration of his or her current term and any newly created directorships or any decrease in directorships shall be so assigned among the classes by a majority of the directors then in office, though less than a quorum, as to make all classes as nearly equal in number as may be feasible. No decrease in the number of directors shall shorten the term of any incumbent director.

Election of directors at all meetings of the shareholders at which directors are to be elected shall be by written ballot, and, except with respect to the right of the holders of any series of Preferred Stock then outstanding to elect additional directors under specified circumstances, a plurality of the votes cast thereat shall elect directors.

Notwithstanding any other provision hereof, this ARTICLE 4 may not be altered, amended or repealed without by the affirmative vote of holders of at least 66 2/3% of the outstanding voting stock of the Corporation.

ARTICLE 5.

The liability of the directors of the Corporation for monetary damages shall be eliminated to the fullest extent permissible under California law.

ARTICLE 6.

The Corporation is authorized to provide indemnification of agents, as defined in Section 317 of the California General Corporation law, through bylaw provisions, agreements with such agents, votes of shareholders or disinterested directors otherwise, or any combination of the foregoing, in excess of the indemnification otherwise permitted by said Section 317, subject only

 

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to the limits set forth in Section 204 of the California General Corporation Law with respect to actions for breach of duty of the Corporation and its shareholders.

*   *   *

3. The foregoing amendment and restatement of the Articles of Incorporation of NovaBay Pharmaceuticals, Inc. has been duly approved by the Board of Directors of said corporation.

4. The foregoing Amended and Restated Articles of Incorporation has been duly approved by the required vote of the shareholders of the Corporation in accordance with sections 603 and 903 of the California Corporations Code. The total number of outstanding shares of the Corporation entitled to vote with respect to the foregoing amendment and restatement of the Articles of Incorporation was 12,922,618 shares of Common Stock, 3,215,032 shares of Series A Preferred Stock, 6,864,410 shares of Series B Preferred Stock, 6,666,659 shares of Series C Preferred Stock and 2,481,094 shares of Series D Preferred Stock. The number of shares voting in favor of this amendment and restatement equaled or exceeded the vote required, such required vote being (i) a majority of the outstanding shares of Common Stock, (ii) a majority of the outstanding shares of Preferred Stock, (iii) a majority of the outstanding shares of Common Stock and Preferred Stock voting together a single class, on an as-converted basis, and (iv) a majority of the outstanding shares of Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock and Series D Preferred Stock, each voting as a separate class.

[SIGNATURE PAGE FOLLOWS]

 

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We further declare under penalty of perjury under the laws of the State of California that the matters set forth in this certificate are true and correct of our own knowledge.

Dated:                          , 2007

 

     
Ramin Najafi, President
     
Robert R. Tufts, Secretary

 

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Exhibit 3.4

AMENDED AND RESTATED BYLAWS

OF

NOVABAY PHARMACEUTICALS, INC.


TABLE OF CONTENTS

 

     PAGE

ARTICLE I OFFICES

   1

1. Principal Offices

   1

2. Other Offices

   1

ARTICLE II MEETINGS OF SHAREHOLDERS

   1

1. Place of Meetings

   1

2. Annual Meeting

   1

3. Special Meeting

   1

4. Notice of Shareholders’ Meetings

   2

5. Manner of Giving Notice; Affidavit of Notice

   2

6. Quorum

   5

7. Adjourned Meeting; Notice

   6

8. Voting

   6

9. Waiver of Notice or Consent by Absent Shareholders

   7

10. Shareholder Action by Written Consent Without a Meeting

   7

11. Record Date for Shareholder Notice, Voting, and Giving Consents

   7

12. Proxies

   8

13. Inspectors of Election

   8

ARTICLE III DIRECTORS

   9

1. Powers

   9

2. Number and Qualification of Directors

   9

3. Election and Term of Office of Directors

   10

4. Vacancies

   10

5. Place of Meetings and Meetings by Telephone

   11

6. Annual Meeting

   11

7. Other Regular Meetings

   11

8. Special Meetings

   11

9. Quorum

   12

10. Waiver of Notice

   12

11. Adjournment

   12

12. Notice of Adjournment

   12

13. Action Without Meeting

   12

14. Fees and Compensation of Directors

   12

ARTICLE IV COMMITTEES

   12

1. Committees of Directors

   12

2. Meetings and Action of Committees

   13

ARTICLE V OFFICERS

   13

1. Officers

   13

2. Election of Officers

   14


TABLE OF CONTENTS

(continued)

 

     PAGE

3. Subordinate Officers

   14

4. Removal and Resignation of Officers

   14

5. Vacancies in Offices

   14

6. Chairman of the Board

   14

7. President

   14

8. Vice Presidents

   15

9. Secretary

   15

10. Treasurer

   15

ARTICLE VI INDEMNIFICATION OF DIRECTORS, OFFICERS, EMPLOYEES, AND OTHER AGENTS

   16

1. Agents, Proceedings, and Expenses

   16

2. Right to Indemnification

   16

3. Right of Indemnitee to Bring Suit

   17

4. Indemnification of Other Agents of the Corporation

   17

5. Other Contractual Rights

   17

6. Limitations

   18

7. Insurance

   18

8. Fiduciaries of Corporate Employee Benefit Plan

   18

9. Amendment of Provisions of Article VI

   19

ARTICLE VII RECORDS AND REPORTS

   19

1. Maintenance and Inspection of Share Register

   19

2. Maintenance and Inspection of Bylaws

   19

3. Maintenance and Inspection of Other Corporate Records

   20

4. Inspection by Directors

   20

5. Annual Report to Shareholders

   20

6. Financial Statements to Shareholders

   20

7. Preparation of Financial Statements

   21

8. Maintenance and Inspection of Financial Statements

   21

ARTICLE VIII GENERAL CORPORATE MATTERS

   21

1. Record Date for Purposes Other Than Notice and Voting

   21

2. Endorsement of Documents; Contracts

   21

3. Certificates for Shares

   22

4. Lost Certificates

   23

5. Representation of Shares of Other Corporations

   23

6. Construction and Definitions

   23

ARTICLE IX AMENDMENTS

   23

1. Amendment by Shareholders

   23

2. Amendment by Directors

   23

 

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ARTICLE I

OFFICES

Section 1. Principal Offices . The board of directors shall fix the location of the principal executive office of the corporation at any place within or outside the State of California. If the principal executive office is located outside this state, and the corporation has one or more business offices in this state, the board of directors shall fix and designate a principal business office in the State of California.

Section 2. Other Offices . The board of directors may at any time establish branch or subordinate offices at any place or places within or outside the State of California.

ARTICLE II

MEETINGS OF SHAREHOLDERS

Section 1. Place of Meetings . Meetings of shareholders shall be held at any place within or outside the State of California designated either by the board of directors or the president (if not contrary to any action taken by the board of directors). In the absence of any such designation, shareholders’ meetings shall be held at the principal executive office of the corporation.

Section 2. Annual Meeting . An annual meeting of shareholders shall be held each year on a date and at a time designated by the board of directors. At that meeting, directors shall be elected. Any other proper business may be transacted at the annual meeting of shareholders.

Section 3. Special Meeting . A special meeting of the shareholders may be called at any time by the board of directors, or by the chairman of the board, or by the president, or by one or more shareholders holding shares in the aggregate entitled to cast not less than 10% of the votes at that meeting.

If a special meeting is called by any person or persons other than the board of directors, the president or the chairman of the board, the request shall be in writing, specifying the time of such meeting (such time to be not less than thirty-five (35) nor more than sixty (60) days after the receipt of the request) and the general nature of the business proposed to be transacted, and shall be delivered personally or sent by registered mail or by telegraphic or other facsimile transmission to the chairman of the board, the president, any vice president, or the secretary of the corporation. The officer receiving the request shall cause notice to be given promptly to the shareholders entitled to vote, in accordance with the provisions of Sections 4 and 5 of this Article II, that a meeting will be held at the time requested by the person or persons calling the meeting.

 

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This Section 3 of Article II may not be altered, amended or repealed except by the board of directors or by the affirmative vote of holders of at least 66 2/3% of the outstanding voting stock of the corporation.

Section 4. Notice of Shareholders’ Meetings . All notices of meetings of shareholders shall be sent or otherwise given in accordance with Section 5 of this Article II not less than ten (10) (or, if sent by third-class mail pursuant to Section 5 below, thirty (30)) nor more than sixty (60) days before the date of the meeting. The notice shall specify the place, date and hour of the meeting and (i) in the case of a special meeting, the general nature of the business to be transacted, and no other business may be transacted, or (ii) in the case of the annual meeting, those matters which the board of directors, at the time of giving the notice, intends to present for action by the shareholders, but subject to the provisions of the next paragraph of this Section 4, any proper matter may be presented at the meeting for such action. The notice of any meeting at which directors are to be elected shall include the name of any nominee or nominees whom, at the time of the notice, the board intends to present for election.

If action is proposed to be taken at any meeting for approval of (i) a contract or transaction in which a director has a direct or indirect financial interest, pursuant to Section 310 of the Corporations Code of California (hereinafter, the “Code”), (ii) an amendment of the articles of incorporation, pursuant to Section 902 of that Code, (iii) a reorganization of the corporation, pursuant to Section 1201 of that Code, (iv) a voluntary dissolution of the corporation, pursuant to Section 1900 of that Code, or (v) a distribution in dissolution other than in accordance with the rights of outstanding preferred shares, pursuant to Section 2007 of that Code, the notice shall also state the general nature of that proposal.

Section 5. Manner of Giving Notice; Affidavit of Notice . Notice of any meeting of shareholders (or any report referenced in Article VII of these Bylaws) shall be given either (i) personally, (ii) by electronic transmission by the corporation (as defined in Section 20 of the Code), or (iii) by first-class mail or, if the corporation has outstanding shares held of record by five hundred (500) or more persons (determined as provided in Section 605 of the Code) on the record date for the shareholders’ meeting, notice may be sent third-class mail, or telegraphic or other written communication, charges prepaid, addressed to the shareholder at the address of that shareholder appearing on the books of the corporation or given by the shareholder to the corporation for the purpose of notice. If no such address appears on the corporation’s books or is given, notice shall be deemed to have been given if sent to that shareholder by mail or telegraphic or other written communication to the corporation’s principal executive office, or if published at least once in a newspaper of general circulation in the county where that office is located. Notice (or any report referenced in Article VII of these Bylaws) shall be deemed to have been given at the time when delivered personally, sent by electronic transmission by the corporation (as defined in the Code) or deposited in the mail or sent by telegram or other means of written communication.

If any notice (or any report referenced in Article VII of these Bylaws) addressed to a shareholder at the address of that shareholder appearing on the books of the corporation is returned to the corporation by the United States Postal Service marked to indicate that the United States Postal Service is unable to deliver the notice to the shareholder at that address, all future

 

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notices or reports shall be deemed to have been duly given without further mailing if these shall be available to the shareholder on written demand of the shareholder at the principal executive office of the corporation for a period of one year from the date of the giving of the notice.

Notice given by electronic transmission by the corporation under this Section 5 of Article II shall be valid only if it complies with Section 20 of the Code. Notwithstanding the foregoing, notice shall not be given by electronic transmission by the corporation under this Section 5 of Article II after either of the following: (1) the corporation is unable to deliver two consecutive notices to the shareholder by such means; or (2) the inability to so deliver the notices to the shareholder becomes known to the Secretary, any Assistant Secretary, the transfer agent, or other person responsible for the giving of the notice. The report referenced in Article VII of these Bylaws may be sent by electronic transmission by the corporation only if approved by resolution of the board of directors.

An affidavit of the mailing or other means of giving any notice of any shareholders’ meeting may be executed by the secretary, assistant secretary, or any transfer agent of the corporation giving the notice, and if so executed shall be filed and maintained in the minute book of the corporation.

Section 6. Order of Business . The chairman of the board of directors, or such other officer of the corporation designated by a majority of the board of directors, will call meetings of the shareholders to order and will act as presiding officer thereof. Unless otherwise determined by the board of directors prior to the meeting, the presiding officer of the meeting of shareholders will also determine the order of business and have the authority in his or her sole discretion to regulate the conduct of any such meeting, including without limitation by (i) imposing restrictions on the persons (other than shareholders of the corporation or their duly appointed proxies) who may attend any such shareholders’ meeting, (ii) ascertaining whether any shareholder or his or her proxy may be excluded from any meeting of shareholders based upon any determination by the presiding officer, in his or her sole discretion, that any such person has unduly disrupted or is likely to disrupt the proceedings thereat and (iii) determining the circumstances in which any person may make a statement or ask questions at any meeting of shareholders.

At an annual meeting of shareholders, only such business will be conducted or considered as is properly brought before the meeting. To be properly brought before an annual meeting, business must be (i) specified in the notice of meeting (or any supplement thereto) given by or at the direction of the board of directors, (ii) otherwise properly brought before the meeting by the presiding officer or by or at the direction of a majority of the board of directors or (iii) otherwise properly requested to be brought before the meeting by a shareholder of the corporation in accordance with the immediately succeeding sentence. For business to be properly requested by a shareholder to be brought before an annual meeting, the shareholder must (i) be a shareholder of record at the time of the giving of the notice of such annual meeting by or at the direction of the board of directors, (ii) be entitled to vote at such meeting and (iii) have given timely written notice thereof to the Secretary of the corporation in accordance with Section 7 of this Article II.

 

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Nominations of persons for election as directors of the Corporation may be made at an annual meeting of shareholders only (i) by or at the direction of the board of directors or (ii) by any shareholder who is a shareholder of record at the time of the giving of the notice of such annual meeting by or at the direction of the board of directors, who is entitled to vote for the election of directors at such meeting and who has given timely written notice thereof to the Secretary of the corporation in accordance with Section 7 of this Article II and in accordance with the corporation’s Corporate Governance Guidelines. Only persons who are nominated in accordance with this Section 6 of this Article II will be eligible for election at a meeting of shareholders as directors of the corporation. To be timely for purposes of this Section 6 of Article II, a notice of shareholder proposal must be addressed to the chairman of the Nominating and Corporate Governance Committee of the corporation

The determination of whether any business sought to be brought before any annual or special meeting of shareholders is properly brought before such meeting in accordance with this Section 6 of Article II, and whether any nomination of a person for election as a director of the corporation at any annual meeting of shareholders was properly made in accordance with this Section 6 of Article II, will be made by the presiding officer of such meeting. If the presiding officer at such meeting determines that any business is not properly brought before such meeting, or any nomination was not properly made, he or she will so declare to the meeting and any such business will not be conducted or considered and any such nomination will be disregarded.

Section 7. Advance Notice of Shareholder Proposals and Director Nominations . To be a timely notice, a notice of shareholder proposal must be addressed to the Secretary of the corporation and delivered or mailed to and received at the principal executive offices of the corporation not less than 120 calendar days and not more than 150 calendar days prior to the anniversary date of the date (as specified in the corporation’s proxy materials for its immediately preceding annual meeting of shareholders) on which the corporation first mailed its proxy materials for its immediately preceding annual meeting of shareholders; provided, however, that in the event the annual meeting is called for a date that is not within thirty (30) calendar days of the anniversary date of the date on which the immediately preceding annual meeting of shareholders was called, to be timely, notice by the shareholder must be so received not later than the close of business on the tenth (10th) calendar day following the day on which public announcement of the date of the annual meeting is first made. In no event will the public announcement of an adjournment of an annual meeting of shareholders commence a new time period for the giving of a shareholder’s notice as provided above.

In the case of a request by a shareholder for business to be brought before any annual meeting of shareholders, a shareholder’s notice to the Secretary of the corporation must set forth as to each matter the shareholder proposes to bring before the annual meeting (i) a description in reasonable detail 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 address, as they appear on the corporation’s books, of the shareholder proposing such business and the beneficial owner, if any, on whose behalf the proposal is made, (iii) the class and number of shares of the corporation that are owned beneficially and of record by the shareholder proposing such business and by the beneficial owner, if any, on whose behalf the proposal is made, and (iv) any material interest of such shareholder proposing such business and the beneficial owner, if any, on whose behalf the proposal is made in such business.

 

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In the case of a nomination by a shareholder of a person for election as a director of the corporation at any annual meeting of shareholders, a shareholder notice to the Secretary of the corporation must set forth (i) the shareholder’s intent to nominate one or more persons for election as a director of the corporation, the name of each such nominee proposed by the shareholder giving the notice, and the reason for making such nomination at the annual meeting, (ii) the name and address, as they appear on the corporation’s books, of the shareholder proposing such nomination and the beneficial owner, if any, on whose behalf the nomination is proposed, (iii) the class and number of shares of the corporation that are owned beneficially and of record by the shareholder proposing such nomination and by the beneficial owner, if any, on whose behalf the nomination is proposed, (iv) any material interest of such shareholder proposing such nomination and the beneficial owner, if any, on whose behalf the proposal is made, (v) a description of all arrangements or understandings between or among any of (A) the shareholder giving the notice, (B) each nominee and (C) any other person or persons (naming such person or persons) pursuant to which the nomination or nominations are to be made by the shareholder giving the notice, (vi) such information as the board of directors or a nomination or similar committee appointed by the board of directors may require pursuant to resolutions of the board of directors or such committee’s charter, (vii) such other information regarding each nominee proposed by the shareholder giving the notice as would be required to be included in a proxy statement filed in accordance with the proxy rules of the United States Securities and Exchange Commission had the nominee been nominated, or intended to be nominated, by the board of directors and (viii) the signed consent of each nominee proposed by the shareholder giving the notice to serve as a director of the corporation if so elected.

Notwithstanding the provisions of Sections 6 and 7 of this Article II, a shareholder must also comply with all applicable requirements of the Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder with respect to the matters set forth in Sections 6 and 7 of this Article II. Nothing in Sections 6 and 7 of this Article II will be deemed to affect any rights of shareholders to request inclusion of proposals in the corporation’s proxy statement in accordance with the provisions of Rule 14a-8 under the Securities Exchange Act of 1934, as amended.

For purposes of this Section 7 of Article II, “public announcement” means disclosure in a press release reported by the Dow Jones News Service, Associated Press or comparable national news service or in a document publicly filed by the corporation with the United States Securities and Exchange Commission pursuant to Sections 13, 14 or 15(d) of the Securities Exchange Act of 1934, as amended, or furnished to shareholders.

This Section 7 of Article II may not be altered, amended or repealed except by the board of directors or by the affirmative vote of holders of at least 66 2/3% of the outstanding voting stock of the corporation.

Section 8. Quorum . The presence in person or by proxy of the holders of a majority of the shares entitled to vote at any meeting of shareholders shall constitute a quorum for the

 

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transaction of business. The shareholders present at a duly called or held meeting at which a quorum is present may continue to do business until adjournment, notwithstanding the withdrawal of enough shareholders to leave less than a quorum, if any action taken (other than adjournment) is approved by at least a majority of the shares required to constitute a quorum.

Section 9. Adjourned Meeting; Notice . Any shareholders’ meeting, annual or special, whether or not a quorum is present, may be adjourned from time to time by the vote of the majority of the shares represented at that meeting, either in person or by proxy, but in the absence of a quorum, no other business may be transacted at that meeting, except as provided in Section 6 of this Article II.

When any meeting of shareholders, either annual or special, is adjourned to another time or place, notice need not be given of the adjourned meeting if the time and place are announced at a meeting at which the adjournment is taken, unless a new record date for the adjourned meeting is fixed, or unless the adjournment is for more than forty-five (45) days from the date set for the original meeting, in which case the board of directors shall set a new record date. Notice of any such adjourned meeting shall be given to each shareholder of record entitled to vote at the adjourned meeting in accordance with the provisions of Sections 4 and 5 of this Article II. At any adjourned meeting the corporation may transact any business which might have been transacted at the original meeting.

Section 10. Voting . The shareholders entitled to vote at any meeting of shareholders shall be determined in accordance with the provisions of Section 13 of this Article II, subject to the provisions of Sections 702 to 704, inclusive, of the Code (relating to voting shares held by a fiduciary, in the name of a corporation, or in joint ownership).

All shareholders’ vote with respect to any matter to be voted on at all meetings of the shareholders shall be by written ballot.

Except as provided in the last paragraph of this Section 10 of Article II, or as provided elsewhere in the articles of incorporation, each outstanding share shall be entitled to one vote on each matter submitted to a vote of the shareholders. Any holder of shares entitled to vote on any matter may vote a part of the shares in favor of the proposal and refrain from voting the remaining shares or, except when the matter is the election of directors, vote them against the proposal, but, if the shareholder fails to specify the number of shares which the shareholder is voting affirmatively, it will be conclusively presumed that the shareholder’s approving vote is with respect to all shares that the shareholder is entitled to vote.

The affirmative vote of a majority of the shares represented and voting at a duly held meeting at which a quorum is present (which shares voting affirmatively also constitute at least a majority of the required quorum) shall be the act of the shareholders, unless the vote of a greater number or voting by classes is required by the Code or by the articles of incorporation, or these bylaws.

The shareholders of the corporation shall not have the right to cumulate their votes for the election of directors of the corporation.

 

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Section 11. Waiver of Notice or Consent by Absent Shareholders . The transactions of any meeting of shareholders, either annual or special, however called and noticed, and wherever held, shall be as valid as though had at a meeting duly held after regular call and notice, if a quorum be present either in person or by proxy, and if, either before or after the meeting, each person entitled to vote, who was not present in person or by proxy, signs a written waiver of notice or a consent to a holding of the meeting, or an approval of the minutes. Such waiver, consent or approval need not specify either the business to be transacted or the purpose of any annual or special meeting of shareholders, except that if action is taken or proposed to be taken for approval of any of those matters specified in the second paragraph of Section 4 of this Article II, such waiver, consent or approval shall state the general nature of the proposal. All such waivers, consents or approvals shall be filed with the corporate records or made a part of the minutes of the meeting.

Attendance by a person at a meeting shall also constitute a waiver of notice of and presence at that meeting, except when the person objects, at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened, and except that attendance at a meeting is not a waiver of any right to object to the consideration of matters required by law to be included in the notice of the meeting but not so included if that objection is expressly made at the meeting.

Section 12. Shareholder Action by Written Consent Without a Meeting . Any action which may be taken at an annual or special meeting of shareholders (except for the removal of a director or filling a vacancy on the board of directors caused by shareholder removal as provided for in Section 3 of Article III) may be taken without prior notice, without a meeting and without a vote, if (i) a consent in writing shall be signed by the holders of outstanding stock having not less than the minimum number of votes that would be necessary to authorize or take such action at a duly called meeting at which all shares entitled to vote thereon were present and voted and (ii) such matter acted upon by the shareholders in such written consent was previously approved by the board of directors for shareholder action by written consent without prior notice, without the holding of a meeting and without a vote. This Section 12 of Article II may not be altered, amended or repealed except by the board of directors or by the affirmative vote of holders of at least 66 2/3% of the outstanding voting stock of the corporation.

Section 13. Record Date for Shareholder Notice, Voting, and Giving Consents . For purposes of determining the shareholders entitled to notice of any meeting, the board of directors may fix, in advance, a record date, which shall not be more than sixty (60) days nor less than ten (10) days before the date of any such meeting, and in this event only shareholders of record at the close of business on the date so fixed are entitled to notice and to vote, notwithstanding any transfer of any shares on the books of the corporation after the record date, except as otherwise provided in the Code.

If the board of directors does not so fix a record date, then the record date for determining shareholders entitled to notice of or to vote at a meeting of shareholders shall be at the close of business on the business day next preceding the day on which notice is given or, if notice is waived, at the close of business on the business day next preceding the day on which the meeting is held.

 

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Section 14. Proxies . Every person entitled to vote for directors or on any other matter shall have the right to do so either in person or by one or more agents authorized by a written proxy signed by the person and filed with the secretary of the corporation. A proxy shall be deemed signed if the shareholder’s name is placed on the proxy (whether by manual signature, typewriting, telegraphic or electronic transmission, or otherwise) by the shareholder or the shareholder’s attorney in fact. A validly executed proxy which does not state that it is irrevocable shall continue in full force and effect unless (i) revoked by the person executing it, before the vote pursuant to that proxy, by a writing delivered to the corporation stating that the proxy is revoked, or by a subsequent proxy executed by the person executing the prior proxy and presented to the meeting, or as to any meeting by attendance at such meeting and voting in person by the person executing the proxy; or (ii) written notice of the death or incapacity of the maker of that proxy is received by the corporation before the vote pursuant to that proxy is counted; provided, however, that no proxy shall be valid after the expiration of eleven (11) months from the date of the proxy, unless otherwise provided in the proxy. The dates contained on the forms of proxy presumptively determine the order of execution, regardless of the postmark dates on the envelopes in which they are mailed. The revocability of a proxy that states on its face that it is irrevocable shall be governed by the provisions of Sections 705(e) and 705(f) of the Code.

Section 15. Inspectors of Election . Before any meeting of shareholders, the board of directors may appoint any persons other than nominees for office to act as inspectors of election at the meeting or its adjournment. If no inspectors of election are so appointed, the chairman of the meeting may, and on the request of any shareholder or a shareholder’s proxy shall, appoint inspectors of election at the meeting. The number of inspectors shall be either one (1) or three (3). If inspectors are appointed at a meeting on the request of one or more shareholders or proxies, the holders of a majority of shares or their proxies present at the meeting shall determine whether one (1) or three (3) inspectors are to be appointed. If any person appointed as inspector fails to appear or fails or refuses to act, the chairman of the meeting may, and upon the request of any shareholder or a shareholder’s proxy shall, appoint a person to fill that vacancy.

These inspectors shall:

(a) Determine the number of shares outstanding and the voting power of each, the shares represented at the meeting, the existence of a quorum, and the authenticity, validity, and effect of proxies;

(b) Receive votes, ballots, or consents;

(c) Hear and determine all challenges and questions in any way arising in connection with the right to vote;

(d) Count and tabulate all votes or consents;

(e) Determine when the polls shall close;

(f) Determine the result; and

 

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(g) Do any other acts that may be proper to conduct the election or vote with fairness to all shareholders.

ARTICLE III

DIRECTORS

Section 1. Powers . Subject to the provisions of the California General Corporation Law and any limitations in the articles of incorporation and these bylaws relating to action required to be approved by the shareholders or by the outstanding shares, the business and affairs of the corporation shall be managed and all corporate powers shall be exercised by or under the direction of the board of directors.

Without prejudice to these general powers, and subject to the same limitations, the directors shall have the power to:

(a) Select and remove all officers, agents, and employees of the corporation; prescribe any powers and duties for them that are consistent with law, with the articles of incorporation, and with these bylaws; fix their compensation; and require from them security for faithful service.

(b) Change the principal executive office or the principal business office in the State of California from one location to another; cause the corporation to be qualified to do business in any other state, territory, dependency, or country and conduct business within or without the State of California; and designate any place within or without the State of California for the holding of any shareholders’ meeting, or meetings, including annual meetings.

(c) Adopt, make, and use a corporate seal; prescribe the forms of certificates of stock; and alter the form of the seal and certificates.

(d) Authorize the issuance of shares of stock of the corporation on any lawful terms, in consideration of money paid, labor done, services actually rendered, debts or securities cancelled, or tangible or intangible property actually received.

(e) Borrow money and incur indebtedness on behalf of the corporation, and cause to be executed and delivered for the corporation’s purposes, in the corporate name, promissory notes, bonds, debentures, deeds of trust, mortgages, pledges, hypothecations, and other evidence of debt and securities.

Section 2. Number and Qualification of Directors . The number of directors of the corporation shall be not less than six (6) nor more than eleven (11). The exact number of directors shall be eight (8) until changed, within the limits specified above, by a bylaw amending this Section 2 of Article III, duly adopted by the board of directors. The indefinite number of directors may be changed, or a definite number fixed without provision for an indefinite number, by a duly adopted amendment to the articles of incorporation or by an amendment to this bylaw duly adopted by the vote of holders of at least 66 2/3% of the outstanding shares entitled to vote;

 

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provided, however, that an amendment reducing the fixed number or the minimum number of directors to a number less than five (5) cannot be adopted if the votes cast against its adoption at a meeting of the shareholders are equal to more than 16-2/3% of the outstanding shares entitled to vote. No amendment may change the stated maximum number of authorized directors to a number greater than two times the stated minimum number of directors minus one. This Section 2 of Article III may not be altered, amended or repealed except by the board of directors or by the affirmative vote of holders of at least 66 2/3% of the outstanding voting stock of the corporation.

Section 3. Election and Term of Office of Directors . Directors shall be elected at each annual meeting of the shareholders to hold office until the next annual meeting. Each director, including a director elected to fill a vacancy, shall hold office until the expiration of the term for which elected and until a successor has been elected and qualified.

Section 4. Vacancies . Any vacancies in the board of directors, by reason of an increase in the number of directors, removal by the shareholders or otherwise, may be filled by a majority of the remaining directors, though less than a quorum, or by a sole remaining director; provided that a vacancy created by the removal of a director by the vote of the shareholders or by court order may also be filled by the affirmative vote of a majority of the shares represented and voting at a duly held meeting at which a quorum is present (which shares voting affirmatively also constitute a majority of the required quorum) or by the unanimous written consent of all shares entitled to vote for the election of directors. Each director so elected shall hold office until the next annual meeting of the shareholders and until a successor has been elected and qualified.

A vacancy or vacancies in the board of directors shall be deemed to exist in the event of the death, resignation, or removal of any director, or if the board of directors by resolution declares vacant the office of a director who has been declared of unsound mind by an order of court or convicted of a felony, or if the authorized number of directors is increased, or if the shareholders fail, at any meeting of shareholders at which any director or directors are elected, to elect the number of directors to be voted for at that meeting.

The shareholders may elect a director or directors at any time to fill any vacancy or vacancies not filled by the directors, but any such election to fill a vacancy created by removal shall require the consent of a majority of the outstanding shares entitled to vote.

Any director may resign effective on giving written notice to the chairman of the board, the president, the secretary, or the board of directors, unless the notice specifies a later time for that resignation to become effective. If the resignation of a director is effective at a future time, the board of directors may elect a successor to take office when the resignation becomes effective.

No reduction of the authorized number of directors shall have the effect of removing any director before that director’s term of office expires.

This Section 4 of Article III may not be altered, amended or repealed except by the board of directors or by the affirmative vote of holders of at least 66 2/3% of the outstanding voting stock of the corporation.

 

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Section 5. Place of Meetings and Meetings by Telephone or Electronic Transmission . Regular meetings of the board of directors may be held at any place within or outside the State of California that has been designated from time to time by resolution of the board of directors. In the absence of such a designation, regular meetings shall be held at the principal executive office of the corporation. Special meetings of the board of directors may be held at any place within or outside the State of California that has been designated in the notice of the meeting or, if not stated in the notice or if there is no notice, at the principal executive office of the corporation.

Members of the board of directors may participate in a meeting through the use of conference telephone, electronic video screen communication or electronic transmission by the corporation and electronic transmission to the corporation. Participation in a meeting through use of conference telephone or electronic video screen communication pursuant to this paragraph constitutes presence in person at such meeting as long as all members participating in the meeting are able to hear one another. Participation in a meeting through electronic transmission by and to the corporation (other than conference telephone and electronic video screen communication) pursuant to this paragraph constitutes presence in person at such meeting if both of the following apply: (A) each member participating in the meeting can communicate with all of the other members concurrently; and (B) each member is provided the means of participating in all matters before the board of directors, including, without limitation, the capacity to propose, or to interpose an objection to, a specific action to be taken by the corporation.

Section 6. Annual Meeting . Immediately following each annual meeting of shareholders, the board of directors shall hold a regular meeting for the purpose of organization, any desired election of officers, and the transaction of other business. Notice of this meeting shall not be required.

Section 7. Other Regular Meetings . Other regular meetings of the board of directors shall be held without call at such time as shall from time to time be fixed by the board of directors. Such regular meetings may be held without notice.

Section 8. Special Meetings . Special meetings of the board of directors for any purpose or purposes may be called at any time by the chairman of the board or the president or any vice president or secretary or any two directors.

Notice of the time and place of special meetings shall be delivered personally or by telephone to each director or sent by first-class mail or telegram, charges prepaid, addressed to each director at that director’s address as it is shown on the records of the corporation. In case the notice is mailed, it shall be deposited in the United States mail at least four (4) days before the time of the holding of the meeting. In case the notice is delivered personally, or by telephone or telegram, it shall be delivered personally, or by telephone or to the telegraph company, at least forty-eight (48) hours before the time of the holding of the meeting. Any oral notice given personally or by telephone may be communicated either to the director or to a person at the office of the director who the person giving the notice has reason to believe will promptly communicate it to the director. The notice need not specify the purpose of the meeting nor the place if the meeting is to be held at the principal executive office of the corporation.

 

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Section 9. Quorum . A majority of the authorized number of directors shall constitute a quorum for the transaction of business, except to adjourn as provided in Section 11 of this Article III. Every act or decision done or made by a majority of the directors present at a meeting duly held at which a quorum is present shall be regarded as the act of the board of directors, subject to the provisions of Section 310 of the Code (as to approval of contracts or transactions in which a director has a direct or indirect material financial interest), Section 311 of that Code (as to appointment of committees), and Section 317(e) of that Code (as to indemnification of directors), the articles of incorporation, and other applicable law. A meeting at which a quorum is initially present may continue to transact business notwithstanding the withdrawal of directors, if any action taken is approved by at least a majority of the required quorum for that meeting.

Section 10. Waiver of Notice . Notice of a meeting need not be given to any director who signs a waiver of notice or a consent to holding the meeting or an approval of the minutes thereof, either before or after the meeting, or who attends the meeting without protesting, prior thereto or at its commencement, the lack of notice to said director. All such waivers, consents, and approvals shall be filed with the corporate records or made a part of the minutes of the meeting. A waiver of notice need not specify the purpose of any regular or special meeting of the board of directors.

Section 11. Adjournment . A majority of directors present, whether or not constituting a quorum, may adjourn any meeting to another time and place.

Section 12. Notice of Adjournment . Notice of the time and place of holding an adjourned meeting need not be given, unless the meeting is adjourned for more than twenty-four hours, in which case notice of the time and place shall be given before the time of the adjourned meeting, in the manner specified in Section 8 of this Article III, to the directors who were not present at the time of adjournment.

Section 13. Action Without Meeting . Any action required or permitted to be taken by the board of directors may be taken without a meeting, if all members of the board shall individually or collectively consent in writing to that action. Such action by written consent shall have the same force and effect as a unanimous vote of the board of directors. Such written consent or consents shall be filed with the minutes of the proceedings of the board.

Section 14. Fees and Compensation of Directors . Directors and members of committees may receive such compensation, if any, for their services, and such reimbursement of expenses, as may be fixed or determined by resolution of the board of directors. This Section 14 shall not be construed to preclude any director from serving the corporation in any other capacity as an officer, agent, employee, or otherwise, and receiving compensation for those services.

ARTICLE IV

COMMITTEES

Section 1. Committees of Directors . The board of directors may, by resolution adopted by a majority of the authorized number of directors, designate one or more committees, each

 

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consisting of two or more directors, to serve at the pleasure of the board of directors. The board of directors may designate one or more directors as alternate members of any committee, who may replace any absent member at any meeting of the committee. The appointment of members or alternate members of a committee requires the vote of a majority of the authorized number of directors. Any committee, to the extent provided in the resolution of the board, shall have all the authority of the board of directors, except with respect to:

(a) the approval of any action which, under the Code, also requires shareholders’ approval or approval of the outstanding shares;

(b) the filling of vacancies on the board of directors or in any committee;

(c) the fixing of compensation of the directors for serving on the board or on any committee;

(d) the amendment or repeal of bylaws or the adoption of new bylaws;

(e) the amendment or repeal of any resolution of the board of directors which by its express terms is not so amendable or repealable;

(f) a distribution to the shareholders of the corporation, except at a rate or in a periodic amount or within a price range determined by the board of directors; or

(g) the appointment of any other committees of the board of directors or the members of these committees.

Section 2. Meetings and Action of Committees . Meetings and action of committees shall be governed by, and held and taken in accordance with, the provisions of Article III of these bylaws, Sections 5 (place of meetings), 7 (regular meetings), 8 (special meetings and notice), 9 (quorum), 10 (waiver of notice), 11 (adjournment), 12 (notice of adjournment), and 13 (action without meeting), with such changes in the context of those bylaws as are necessary to substitute the committee and its members for the board of directors and its members, except that the time of regular meetings of committees may be determined either by resolution of the board of directors or by resolution of the committee; special meetings of committees may also be called by resolution of the board of directors; and notice of special meetings of committees shall also be given to all alternate members, who shall have the right to attend all meetings of the committee. The board of directors may adopt rules for the government of any committee not inconsistent with the provisions of these bylaws.

ARTICLE V

OFFICERS

Section 1. Officers . The officers of the corporation shall be a president, a vice president, a secretary and a treasurer. The corporation may also have, at the discretion of the board of directors, a chairman of the board, one or more additional vice presidents, one or more

 

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assistant vice presidents, one or more assistant secretaries, and such other officers as may be appointed in accordance with the provisions of Section 3 of this Article V. Any number of offices may be held by the same person.

Section 2. Election of Officers . The officers of the corporation, except such officers as may be appointed in accordance with the provisions of Section 3 or Section 5 of this Article V, shall be chosen by the board of directors, and each shall serve at the pleasure of the board, subject to the rights, if any, of an officer under any contract of employment.

Section 3. Subordinate Officers . The board of directors may appoint, and may empower the president to appoint, such other officers as the business of the corporation may require, each of whom shall hold office for such period, have such authority and perform such duties as are provided in the bylaws or as the board of directors may from time to time determine.

Section 4. Removal and Resignation of Officers . Subject to the rights, if any, of an officer under any contract of employment, any officer may be removed, either with or without cause, by the board of directors, at any regular or special meeting of the board, or, except in case of an officer chosen by the board of directors, by any officer upon whom such power of removal may be conferred by the board of directors.

Any officer may resign at any time by giving written notice to the corporation. Any resignation shall take effect at the date of the receipt of that notice or at any later time specified in that notice; and, unless otherwise specified in that notice, the acceptance of the resignation shall not be necessary to make it effective. Any resignation is without prejudice to the rights, if any, of the corporation under any contract to which the officer is a party.

Section 5. Vacancies in Offices . A vacancy in any office because of death, resignation, removal, disqualification or any other cause shall be filled in the manner prescribed in these bylaws for regular appointments to that office.

Section 6. Chairman of the Board . The chairman of the board, if such an officer be elected, shall, if present, preside at meetings of the board of directors and exercise and perform such other powers and duties as may be from time to time assigned to him by the board of directors or prescribed by the bylaws. If there is no president, the chairman of the board shall in addition be the chief executive officer of the corporation and shall have the powers and duties prescribed in Section 7 of this Article V.

Section 7. President . Subject to such supervisory powers, if any, as may be given by the board of directors to the chairman of the board, if there be such an officer, the president shall be the chief executive officer of the corporation and shall, subject to the control of the board of directors, have general supervision, direction, and control of the business and the officers of the corporation. In the absence of the chairman of the board, or if there be none, he shall preside at all meetings of the shareholders and at all meetings of the board of directors. He shall have the general powers and duties of management usually vested in the office of president of a corporation, and shall have such other powers and duties as may be prescribed by the board of directors or the bylaws.

 

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Section 8. Vice Presidents . In the absence or disability of the president, the vice presidents, if any, in order of their rank as fixed by the board of directors or, if not ranked, a vice president designated by the board of directors, shall perform all the duties of the president, and when so acting shall have all the powers of, and be subject to all the restrictions upon, the president. The vice presidents shall have such other powers and perform such other duties as from time to time may be prescribed for them respectively by the board of directors or the bylaws, and the president, or the chairman of the board.

Section 9. Secretary . The secretary shall keep or cause to be kept, at the principal executive office or such other place as the board of directors may direct, a book of minutes of all meetings and actions of the directors, committees of directors, and shareholders, with the time and place of holding, whether regular or special, and, if special, how authorized, the notice given, the names of those present at directors’ meetings or committee meetings, the number of shares present or represented at shareholders’ meetings, and the proceedings.

The secretary shall keep, or cause to be kept, at the principal executive office or at the office of the corporation’s transfer agent or registrar, as determined by resolution of the board of directors, a share register, or a duplicate share register, showing the names of all shareholders and their addresses, the number and classes of shares held by each, the number and date of certificates issued for the same, and the number and date of cancellation of every certificate surrendered for cancellation.

The secretary shall give, or cause to be given, notice of all meetings of the shareholders and of the board of directors required by the bylaws or by law to be given, and he shall keep the seal of the corporation if one be adopted, in safe custody, and shall have such other powers and perform such other duties as may be prescribed by the board of directors or by the bylaws.

Section 10. Treasurer . Unless another officer is given such responsibility by the board of directors, the treasurer shall be the chief financial officer of the corporation and shall keep and maintain, or cause to be kept and maintained, adequate and correct accounts of the properties and business transactions of the corporation, including accounts of its assets, liabilities, receipts, disbursements, gains, losses, capital, retained earnings and shares. The books of account shall at all reasonable times be open to inspection by any director.

Unless another officer is given such responsibility by the board of directors, the treasurer shall deposit all monies and other valuables in the name and to the credit of the corporation with such depositaries as may be designated by the board of directors. Unless another officer is given such responsibility by the board of directors, the treasurer shall disburse the funds of the corporation as may be ordered by the board of directors, shall render to the president and directors, whenever they request it, an account of all of his transactions as treasurer and of the financial condition of the corporation, and shall have such other powers and perform such other duties as may be prescribed by the board of directors or the bylaws.

 

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ARTICLE VI

INDEMNIFICATION OF DIRECTORS,

OFFICERS, EMPLOYEES, AND OTHER AGENTS

Section 1. Agents, Proceedings, and Expenses . For the purposes of this Article VI, “agent” means any person who is or was a director, officer, employee, or other agent of this corporation or is or was serving at the request of this corporation as a director, officer, employee, or agent of another foreign or domestic corporation, partnership, joint venture, trust or other enterprise, or was a director, officer, employee, or agent of a foreign or domestic corporation which was a predecessor corporation of this corporation or was serving at the request of such predecessor corporation as a director, officer, employee or agent of another enterprise; “proceeding” means any threatened, pending or completed action or proceeding, whether civil, criminal, administrative, or investigative; and “expenses” includes, without limitation, attorneys’ fees and any expenses of establishing a right to indemnification under Section 3 or the last sentence of Section 4 of this Article VI.

Section 2. Right to Indemnification . The corporation shall indemnify each of its directors and officers who was or is made a party or is threatened to be made a party to or is otherwise involved in any proceeding against expenses, judgments, fines, settlements and other amounts actually and reasonably incurred in connection with any such proceeding arising by reason of the fact any such person is or was an agent of the corporation (hereinafter an “indemnitee”); provided, however, that except as provided in Section 3 hereof with respect to proceedings to enforce rights to indemnification, the corporation shall indemnify any such indemnitee 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 2 of Article VI 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 an advancement of expenses incurred by an indemnitee in his or her capacity as an agent of the corporation (and not in any capacity in which service was or is rendered by such indemnitee to an employee benefit plan) shall be made only upon delivery to the corporation of an undertaking, by or on behalf of such person, to repay all amounts so advanced if it shall ultimately be determined by final judicial decision from which there is no further right to appeal that such indemnitee is not entitled to be indemnified for such expenses under this Section or otherwise (hereinafter an “undertaking”). Notwithstanding the foregoing, no indemnification shall be made to any indemnitee who was or is a party, or is threatened to be made a party, to any threatened, pending or completed action by or in the right of the corporation to procure a judgment in its favor for any of the following:

(a) In respect of any claim, issue or matter as to which the indemnitee shall have been adjudged to be liable to this corporation in the performance of that person’s duty to this corporation and its shareholders, unless and only to the extent that the court in which that proceeding is or was pending shall determine upon application that, in view of all the circumstances of the case, that person is fairly and reasonably entitled to indemnity for the expenses which the court shall determine;

 

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(b) Of amounts paid in settling or otherwise disposing of a pending action without court approval; or

(c) Of expenses incurred in defending a pending action which is settled or otherwise disposed of without court approval.

Section 3. Right of Indemnitee to Bring Suit . Except as may otherwise be provided by an agreement between the corporation and an indemnitee:

If a claim under Section 2 of this Article VI 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. If successful in whole or in part in any such suit or in a suit brought by the corporation to recover an advancement of expenses pursuant to the terms of an undertaking, the indemnitee shall be entitled to be paid also the expense of procuring or defending such suit. In any suit brought by the indemnitee to enforce a right hereunder, or by the corporation to recover an advancement of expenses pursuant to the terms of an undertaking, the burden of proving that the indemnitee is not entitled to be indemnified or to such advancement of expenses under this Section or otherwise shall be on the corporation.

Section 4. Indemnification of Other Agents of the Corporation . The corporation may, to the extent authorized from time to time by the Board of Directors, grant rights to indemnification and to the advancement of expenses to any other agent of the corporation generally or as to any specific legal action and/or instance, by duly adopted resolution of the Board of Directors, agreement or otherwise, up to the fullest extent of the provisions of this Article VI with respect to the indemnification and advancement of expenses of directors and officers of the corporation. Notwithstanding the foregoing, to the extent that an agent of this corporation has been successful on the merits in the defense of any proceeding arising by reason of the fact such person is or was an agent of the corporation, or in the defense of any claim, issue, or matter therein, the agent shall be indemnified against expenses actually and reasonably incurred by the agent in connection therewith.

Section 5. Other Contractual Rights . The indemnification provided by this Article VI shall not be deemed exclusive of any other rights to which a person seeking indemnification may be entitled under any other bylaw provision, agreement, vote of shareholders or disinterested directors or otherwise, both as to action in an official capacity and as to action in another capacity while holding such office, to the extent such additional rights to indemnification are authorized in the Articles Of Incorporation of this corporation. This corporation is expressly permitted to enter into agreements with its agents providing for indemnification beyond the indemnification rights granted in this Article VI to the extent such additional rights to indemnification are authorized in the Articles of Incorporation of this corporation. The rights to indemnity hereunder shall continue as to a person who has ceased to be a director, officer, employee or agent and shall

 

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inure to the benefit of the heirs, executors and administrators of that person. Nothing contained in this Article VI shall affect any right to indemnification to which persons other than directors and officers of this corporation or any subsidiary hereof may be entitled by contract or otherwise.

Section 6. Limitations . No indemnification or advance shall be made under this Article VI, except as provided in the last sentence of Section 4 above or by a court in which any proceeding is or was pending upon application made by this corporation or the indemnitee or the attorney or other person rendering services in connection with such defense, in any circumstance which exceeds the limits set forth in Section 204 of California General Corporation Law or where it appears:

(a) That it would be inconsistent with a provision of the Articles of Incorporation or Bylaws of this corporation, a resolution of the shareholders of this corporation or an agreement in effect at the time of the accrual of the alleged cause of action asserted in the proceeding in which the expenses were incurred or other amounts were paid, which prohibits or otherwise limits indemnification; or

(b) That it would be inconsistent with any condition expressly imposed by a court in approving a settlement.

Any other provision herein to the contrary notwithstanding, the Company shall not be obligated to indemnify an indemnitee for any expenses and/or the payment of profits arising from the purchase and sale by indemnitee of securities in violation of Section 16(b) of the Securities Exchange Act of 1934, as amended, or any similar successor statute.

Section 7. Insurance . Upon and in the event of a determination by the Board of Directors of this corporation to purchase such insurance, this corporation shall purchase and maintain insurance on behalf of any agent of the corporation against any liability asserted against or incurred by the agent in such capacity or arising out of the agent’s status as such whether or not this corporation would have the power to indemnify the agent against that liability under the provisions of this Article VI.

Section 8. Fiduciaries of Corporate Employee Benefit Plan . This Article VI does not apply to any proceeding against any trustee, investment manager, or other fiduciary of an employee benefit plan in that person’s capacity as such, even though that person may also be an agent of this corporation as defined in Section 1 of this Article VI. The corporation shall have power to indemnify such a trustee, investment manager or other fiduciary to the extent permitted by Section 207(f) of the California General Corporation Law.

Section 9. Indemnification Agreements . The board of directors is authorized to enter into a contract with any director, officer, employee or agent of the corporation, or any person who is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, limited liability company, joint venture, trust or other enterprise or entity, including employee benefit plans, or any person who was a director, officer, employee or agent of a corporation which was a predecessor corporation of the corporation or of another enterprise at the request of such predecessor corporation, providing for indemnification rights equivalent to or, if the board of directors so determines and to the extent permitted by applicable law, greater than, those provided for in this Article VI.

 

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Section 10. Amendment of Provisions of Article VI . No amendment of any provision of this Article VI shall reduce the rights to indemnification of any director or officer of this corporation from the rights to indemnification which were set forth in this Article VI at the time of the accrual of the alleged cause of action asserted in any proceeding for which such director or officer is seeking indemnification or an advance of expenses.

ARTICLE VII

RECORDS AND REPORTS

Section 1. Maintenance and Inspection of Share Register . The corporation shall keep at its principal executive office, or at the office of its transfer agent or registrar, if either be appointed and as determined by resolution of the board of directors, a record of its shareholders, giving the names and addresses of all shareholders and the number and class of shares held by each shareholder.

A shareholder or shareholders of the corporation holding at least five percent (5%) in the aggregate of the outstanding voting shares of the corporation may (i) inspect and copy the records of shareholders’ names and address and shareholdings during usual business hours on five (5) days’ prior written demand on the corporation, and (ii) obtain from the transfer agent of the corporation, on written demand and on the tender of such transfer agent’s usual charges for such list, a list of the shareholders’ names and addresses, who are entitled to vote for the election of directors, and their shareholdings, as of the most recent record date for which that list has been compiled or as of a date specified by the shareholder after the date of demand. This list shall be made available to any such shareholder by the transfer agent on or before the later of five (5) days after the demand is received or the date specified in the demand as the date as of which the list is to be compiled. The record of shareholders shall also be open to inspection on the written demand of any shareholder or holder of a voting trust certificate, at any time during usual business hours, for a purpose reasonably related to the holder’s interests as a shareholder or as the holder of a voting trust certificate. Any inspection and copying under this Section 1 may be made in person or by an agent or attorney of the shareholder or holder of a voting trust certificate making the demand.

Section 2. Maintenance and Inspection of Bylaws . The corporation shall keep at its principal executive office, or if its principal executive office is not in the State of California, at its principal business office in this state, the original or a copy of the bylaws as amended to date, which shall be open to inspection by the shareholders at all reasonable times during office hours. If the principal executive office of the corporation is outside the State of California and the corporation has no principal business office in this state, the secretary shall, upon the written request of any shareholder, furnish to that shareholder a copy of the bylaws as amended to date.

 

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Section 3. Maintenance and Inspection of Other Corporate Records . The accounting books and records and minutes of proceedings of the shareholders and the board of directors and any committee or committees of the board of directors shall be kept at such place or places designated by the board of directors, or, in the absence of such designation, at the principal executive office of the corporation. The minutes shall be kept in written form and the accounting books and records shall be kept either in written form or in any other form capable of being converted into written form. The minutes and accounting books and records shall be open to inspection upon the written demand of any shareholder or holder of a voting trust certificate, at any reasonable time during usual business hours, for a purpose reasonably related to the holders’ interests as a shareholder or as the holder of a voting trust certificate. The inspection may be made in person or by an agent or attorney, and shall include the right to copy and make extracts. These rights of inspection shall extend to the records of each subsidiary corporation of the corporation.

Section 4. Inspection by Directors . Every director shall have the absolute right at any reasonable time to inspect all books, records, and documents of every kind and the physical properties of the corporation and each of its subsidiary corporations. This inspection by a director may be made in person or by an agent or attorney and the right of inspection includes the right to copy and make extracts of documents.

Section 5. Annual Report to Shareholders . The board of directors shall cause an annual report to be sent to the shareholders not later than one hundred twenty (120) days after the close of the fiscal year adopted by the corporation. This report shall be sent at least fifteen (15) days (or, if sent by third-class mail, thirty-five (35) days) before the annual meeting of shareholders to be held during the next fiscal year and in the manner specified in Section 5 of Article II of these bylaws for giving notice to shareholders of the corporation. The annual report shall contain a balance sheet as of the end of the fiscal year and an income statement and statement of changes in financial position for the fiscal year, accompanied by any report of independent accountants or, if there is no such report, the certificate of an authorized officer of the corporation that the statements were prepared without audit from the books and records of the corporation.

Section 6. Financial Statements to Shareholders . If no annual report for the last fiscal year has been sent to shareholders, the corporation shall, upon the written request of any shareholder made more than one hundred and twenty (120) days after the close of such fiscal year, deliver or mail to the person making the request within thirty (30) days thereafter a copy of a balance sheet as of the end of such fiscal year and an income statement and statement of changes in financial position for such fiscal year.

If a shareholder or shareholders holding at least five percent (5%) of the outstanding shares of any class of stock of the corporation makes a written request to the corporation for an income statement of the corporation for the three-month, six-month or nine-month period of the then current fiscal year ended more than thirty (30) days before the date of the request, and a balance sheet of the corporation as of the end of that period, the chief financial officer shall cause that statement to be prepared, if not already prepared, and shall deliver personally or mail that statement or statements to the person making the request within thirty (30) days of the request. If the corporation has not sent to the shareholders its annual report for the

 

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last fiscal year, the statements referred to in the first paragraph of this Section 6 shall likewise be delivered or mailed to the shareholder or shareholders within thirty (30) days after the request.

The quarterly income statements and balance sheets referred to in this section shall be accompanied by the report, if any, of any independent accountants engaged by the corporation or the certificate of an authorized officer of the corporation that the financial statements were prepared without audit from the books and records of the corporation.

Section 7. Preparation of Financial Statements . If the corporation has one hundred (100) or fewer shareholders of record of its shares (determined as provided in Section 605 of the California Corporations Code), the financial statements referred to in Sections 5 and 6 of this Article VII are not required to be prepared in conformity with generally accepted accounting principles if they reasonably set forth the rights and liabilities and the income and expense of the corporation and disclose the accounting basis used in their preparation.

Section 8. Maintenance and Inspection of Financial Statements . A copy of the financial statements referred to in Sections 5 and 6 of this Article VII shall be kept on file in the principal office of the corporation for twelve (12) months, and they shall be exhibited at all reasonable times to any shareholder demanding an examination of them or a copy shall be mailed to any such shareholder.

ARTICLE VIII

GENERAL CORPORATE MATTERS

Section 1. Record Date for Purposes Other Than Notice and Voting . For purposes of determining the shareholders 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 other lawful action (other than action by shareholders by written consent without a meeting), the board of directors may fix, in advance, a record date, which shall not be more than sixty (60) days before any such action, and in that case only shareholders of record at the close of business on the date so fixed are entitled to receive the dividend, distribution, or allotment of rights or to exercise the rights, as the case may be, notwithstanding any transfer of any shares on the books of the corporation after the record date so fixed, except as otherwise provided in the California General Corporation Law.

If the board of directors does not so fix a record date, the record date for determining shareholders for any such purpose shall be at the close of business on the day on which the board adopts the applicable resolution or the sixtieth (60th) day before the date of that action, whichever is later.

Section 2. Endorsement of Documents; Contracts . Subject to the provisions of applicable law, any note, mortgage, evidence of indebtedness, contract, share certificate, conveyance, or other instrument in writing and any assignment or endorsements thereof executed or entered into between the corporation and any other person, when signed by the chairman of the board, the president or any vice president, and the secretary, any assistant secretary, the treasurer

 

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or any assistant treasurer of the corporation shall be valid and binding on the corporation in the absence of actual knowledge on the part of the other person that the signing officers had no authority to execute the same. Any such instruments may be signed by any other person or persons in such manner as from time to time shall be determined by the board but, unless so authorized by the board, such person or persons shall have no power or authority to bind the corporation by any contract or engagement or to pledge its credit or to render it liable for any purpose or amount.

Section 3. Certificates for Shares . The shares of the corporation shall be represented by certificates, provided that the Board may provide by resolution or resolutions that some or all of any or all classes or series of its stock shall be uncertificated shares. Any such resolution shall not apply to shares represented by a certificate until such certificate is surrendered to the corporation. Every holder of stock represented by certificates shall be signed in the name of the corporation by the Chairman of the Board, the Chief Executive Officer, the President or any Vice President, and by the Secretary. Any or all of the signatures on the certificates may be a facsimile. In case any officer, transfer agent or registrar who has signed, or whose facsimile signature has been placed upon, any such certificate, shall have ceased to be such officer, transfer agent or registrar before such certificate is issued, such certificate may nevertheless be issued by the corporation with the same effect as though the person who signed such certificate, or whose facsimile signature shall have been placed thereupon, were such an officer, transfer agent or registrar at the date of issue. A record shall be kept of the respective names of the persons, firms or corporations owning the stock represented by such certificates, the number and class or series of shares represented by such certificates, respectively, and the respective dates thereof, and in case of cancellation, the respective dates of cancellation. Every certificate surrendered to the corporation for exchange or transfer shall be canceled, and no new certificate or certificates shall be issued in exchange for any existing certificate until such existing certificate shall have been so canceled, except in cases provided for in Section 6 of this Article VIII hereof.

Section 4. Transfers of Stock . Transfers of shares of stock of the corporation shall be made only on the books of the corporation by the registered holder thereof, or by such holder’s attorney thereunto authorized by power of attorney duly executed and filed with the Secretary, or with a transfer clerk or a transfer agent appointed as provided in Section 5 of this Article VIII hereof, and (i) with regard to certificated shares, upon surrender of the certificate or certificates for such shares properly endorsed and the payment of all taxes thereon, and (ii) with regard to uncertificated shares, upon delivery of an instruction duly executed, and with such proof of the authenticity of the signature as the corporation or its agents may reasonably require. The person in whose name shares of stock stand on the books of the corporation shall be deemed the owner thereof for all purposes as regards the corporation. Whenever any transfer of shares shall be made for collateral security, and not absolutely, such fact shall be so expressed in the entry of transfer if, when the certificate or certificates shall be presented to the corporation for transfer or uncertificated shares are requested to be transferred, both the transferor and the transferee request the corporation to do so.

Section 5. Regulations . The Board may make such rules and regulations as it may deem expedient, not inconsistent with these Bylaws, concerning the issue, transfer and registration of certificates for shares of the stock of the corporation or uncertificated shares of the

 

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corporation. It may appoint, or authorize any officer or officers to appoint, one or more transfer clerks or one or more transfer agents and one or more registrars, and may require all certificates for stock to bear the signature or signatures of any of them

Section 6. Lost Certificates . In any case of loss, theft, destruction, or mutilation of any certificate of stock, a new certificate or certificates or uncertificated shares may be issued in its place upon proof satisfactory to the Board of such loss, theft, destruction, or mutilation and upon the giving of a bond of indemnity to the corporation in such form and in such sum as the Board may direct; provided, however, that a new certificate or uncertificated shares may be issued without requiring any bond when, in the judgment of the Board, it is proper so to do.

Section 7. Representation of Shares of Other Corporations . The chairman of the board, the president, or any vice president, or any other person authorized by resolution of the board of directors or by any of the foregoing designated officers, is authorized to vote on behalf of the corporation any and all shares of any other corporation or corporations, foreign or domestic, standing in the name of the corporation. The authority granted to these officers to vote or represent on behalf of the corporation any and all shares held by the corporation in any other corporation or corporations may be exercised by any of these officers in person or by any person authorized to do so by a proxy duly executed by these officers.

Section 8. Construction and Definitions . Unless the context requires otherwise, the general provisions, rules of construction, and definitions in the California General Corporation Law shall govern the construction of these bylaws. Without limiting the generality of this provision, the singular number includes the plural, the plural number includes the singular, and the term “person” includes both a corporation and a natural person.

ARTICLE IX

AMENDMENTS

Section 1. Amendment by Shareholders . New bylaws may be adopted or these bylaws may be amended or repealed by the vote of holders of a majority of the outstanding shares entitled to vote, except with respect to any section that by its own terms requires a greater percentage vote, in which case such section may only be amended or repealed by the vote of the holders or such increased percentage of the outstanding shares entitled to vote as specified therein; provided, however, that if the articles of incorporation of the corporation set forth the number of authorized directors of the corporation, the authorized number of directors may be changed only by an amendment of the articles of incorporation.

Section 2. Amendment by Directors . Subject to the rights of the shareholders as provided in Section 1 of this Article IX, to adopt, amend, or repeal bylaws, bylaws may be adopted, amended, or repealed by the board of directors; provided, however, that the board of directors may adopt a bylaw or amendment of a bylaw changing the authorized number of directors only for the purpose of fixing the exact number of directors within the limits specified in the articles of incorporation or in Section 2 of Article III of these bylaws.

 

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Exhibit 10.3

 


NOVABAY PHARMACEUTICALS, INC.

2007 OMNIBUS INCENTIVE PLAN

 



Table of Contents

 

Section 1.

  

Purpose

   1

Section 2.

  

Definitions

   1

Section 3.

  

Administration

   4

(a)

  

Power and Authority of the Committee

   4

(b)

   Power and Authority of the Board    5

Section 4.

  

Shares Available for Awards

   5

(a)

   Shares Available    5

(b)

   Accounting for Awards    5

(c)

   Adjustments    5

(d)

   Section 162(m) Award Limitations Under the Plan    6

Section 5.

  

Eligibility

   6

Section 6.

  

Awards

   6

(a)

   Options    6

(b)

   Stock Appreciation Rights    8

(c)

   Restricted Stock and Restricted Stock Units    8

(d)

   Performance Awards    9

(e)

   Dividend Equivalents    9

(f)

   Other Stock Grants    9

(g)

   Other Stock-Based Awards    9

(h)

   General    10

Section 7.

  

Amendment and Termination; Adjustments

   12

(a)

   Amendments to the Plan    12

(b)

   Amendments to Awards    12

(c)

   Correction of Defects, Omissions and Inconsistencies    13

Section 8.

  

Income Tax Withholding

   13

Section 9.

  

General Provisions

   13

(a)

   No Rights to Awards    13

(b)

   Award Agreements    13

(c)

   Plan Provisions Control    13

(d)

   No Rights of Shareholders    13

(e)

   No Limit on Other Compensation Arrangements    14

(f)

   No Right to Employment    14

(g)

   Governing Law    14

(h)

   Severability    14

(i)

   No Trust or Fund Created    14

 

i


(j)

   Other Benefits    15

(k)

   No Fractional Shares    15

(l)

   Headings    15

(m)

   Section 16 Compliance; Section 162(m) Administration    15

(n)

   Conditions Precedent to Issuance of Shares    15

Section 10.

  

Effective Date of the Plan

   15

Section 11.

  

Term of the Plan

   16

 

ii


NOVABAY PHARMACEUTICALS, INC.

2007 OMNIBUS INCENTIVE PLAN

Section 1.    Purpose

The purpose of the Plan is to promote the interests of the Company and its shareholders by aiding the Company in attracting and retaining employees, officers, consultants, independent contractors and directors capable of assuring the future success of the Company, to offer such persons incentives to continue in the Company’s employ or service and to afford such persons an opportunity to acquire a proprietary interest, or otherwise increase their proprietary interest, in the Company.

Section 2.    Definitions

As used in the Plan, the following terms shall have the meanings set forth below:

(a) “ Affiliate ” shall mean (i) any entity that, directly or indirectly through one or more intermediaries, is controlled by the Company and (ii) any entity in which the Company has a significant equity interest, in each case as determined by the Committee.

(b) “ Award ” shall mean any Option, Stock Appreciation Right, Restricted Stock, Restricted Stock Unit, Performance Award, Dividend Equivalent, Other Stock Grant or Other Stock-Based Award granted under the Plan.

(c) “ Award Agreement ” shall mean any written agreement, contract or other instrument or document evidencing an Award granted under the Plan. Each Award Agreement shall be subject to the applicable terms and conditions of the Plan and any other terms and conditions (not inconsistent with the Plan) determined by the Committee.

(d) “ Board ” shall mean the Board of Directors of the Company.

(e) “ Code ” shall mean the Internal Revenue Code of 1986, as amended from time to time, and any regulations promulgated thereunder.

(f) “ Committee ” shall mean a committee of Directors designated by the Board to administer the Plan, which shall initially be the Company’s compensation committee. The Committee shall be comprised of not less than such number of Directors as shall be required to permit Awards granted under the Plan to qualify under Rule 16b-3 and Section 162(m) of the Code, and each member of the Committee shall be a “ Non-Employee Director ” and an “ Outside Director .”

(g) “ Company ” shall mean NovaBay Pharmaceuticals, Inc., a California corporation, and any successor corporation.

(h) “ Director ” shall mean a member of the Board, including any Non-Employee Director.


(i) “ Dividend Equivalent ” shall mean any right granted under Section 6(e) of the Plan.

(j) “ Eligible Person ” shall mean any employee, officer, consultant, independent contractor or director providing services to the Company or any Affiliate who the Committee determines to be an Eligible Person. An Eligible Person must be a natural person.

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

(l) “ Fair Market Value ” shall mean, with respect to any property (including, without limitation, any Shares or other securities), the fair market value of such property determined by such methods or procedures as shall be established from time to time by the Committee. Notwithstanding the foregoing and unless otherwise determined by the Committee, the Fair Market Value of a Share as of a given date shall be, if the Shares are then listed on the American Stock Exchange, the closing price of one Share as reported on the American Stock Exchange on such date or, if the American Stock Exchange is not open for trading on such date, on the most recent preceding date when it is open for trading.

(m) “ Incentive Stock Option ” shall mean an option granted under Section 6(a) of the Plan that is intended to qualify as an “incentive stock option” in accordance with the terms of Section 422 of the Code or any successor provision.

(n) “ Insider ” shall mean (i) an insider (as defined in Section 1 of the Securities Act (Ontario)), except that a person who falls within that definition solely by virtue of being a director or senior officer of a subsidiary or an affiliate (as defined in Sections 1(2) and 1(4), respectively, of the Securities Act (Ontario)) of the Company shall not be an insider for purposes hereof, unless such director or senior officer: (1) in the ordinary course receives or has access to information as to material facts or material changes concerning the Company before the material facts or material changes are generally disclosed, (2) is a director or senior officer of a major subsidiary (as defined in National Instrument 55-101 - Insider Reporting Exemptions) or (3) is an insider of the Company in a capacity other than as a director or senior officer of the subsidiary or affiliate of the Company; and (ii) an associate (as defined in Section 1(1) of the Securities Act (Ontario)) or affiliate of any person who is an insider by virtue of the preceding clause (i).

(o) “ Non-Employee Director ” shall mean any Director who is not also an employee of the Company or an Affiliate within the meaning of Rule 16b-3 (which term “Non-Employee Director” is defined in this paragraph for purposes of the definition of “Committee” only and is not intended to define such term as used elsewhere in the Plan).

(p) “ Non-Qualified Stock Option ” shall mean an option granted under Section 6(a) of the Plan that is not an Incentive Stock Option.

(q) “ Option ” shall mean an Incentive Stock Option or a Non-Qualified Stock Option.

(r) “ Other Stock Grant ” shall mean any right granted under Section 6(f) of the Plan.

 

2


(s) “ Other Stock-Based Award ” shall mean any right granted under Section 6(g) of the Plan.

(t) “ Outside Director ” shall mean any Director who is an “outside director” within the meaning of Section 162(m) of the Code.

(u) “ Participant ” shall mean an Eligible Person designated to be granted an Award under the Plan.

(v) “ Performance Award ” shall mean any right granted under Section 6(d) of the Plan.

(w) “ Performance Goal ” shall mean one or more of the following performance goals, either individually, alternatively or in any combination, applied on a corporate, subsidiary or business unit basis: revenue, cash flow, gross profit, earnings before interest and taxes, earnings before interest, taxes, depreciation and amortization and net earnings, earnings per share, margins (including one or more of gross, operating and net income margins), returns (including one or more of return on assets, equity, investment, capital and revenue and total shareholder return), stock price, economic value added, working capital, market share, cost reductions, workforce satisfaction and diversity goals, employee retention, customer satisfaction, completion of key projects and strategic plan development and implementation. Such goals may reflect absolute entity or business unit performance or a relative comparison to the performance of a peer group of entities or other external measure of the selected performance criteria. Pursuant to rules and conditions adopted by the Committee on or before the 90th day of the applicable performance period for which Performance Goals are established, the Committee may appropriately adjust any evaluation of performance under such goals to exclude the effect of certain events, including any of the following events: asset write-downs; litigation or claim judgments or settlements; changes in tax law, accounting principles or other such laws or provisions affecting reported results; severance, contract termination and other costs related to exiting certain business activities; and gains or losses from the disposition of businesses or assets or from the early extinguishment of debt.

(x) “ Permanent Disability ” shall mean the inability of Participant to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment which can be expected to result in death or has lasted or can be expected to last for a continuous period of twelve months or more.

(y) “ Person ” shall mean any individual or entity, including a corporation, partnership, limited liability company, association, joint venture or trust.

(z) “ Plan ” shall mean the NovaBay Pharmaceuticals, Inc. 2007 Omnibus Incentive Plan, as amended from time to time, the provisions of which are set forth herein.

(aa) “ Qualified Performance Based Award ” shall have the meaning set forth in Section 6(d) of the Plan.

(bb) “ Restricted Stock ” shall mean any Share granted under Section 6(c) of the Plan.

 

3


(cc) “ Restricted Stock Unit ” shall mean any unit granted under Section 6(c) of the Plan evidencing the right to receive a Share (or evidencing the right to receive a cash payment equal to the Fair Market Value of a Share if explicitly so provided in the Award Agreement) at some future date.

(dd) “ Rule 16b-3 ” shall mean Rule 16b-3 promulgated by the Securities and Exchange Commission under the Exchange Act, or any successor rule or regulation.

(ee) “ Section 162(m) ” shall mean Section 162(m) of the Code and the applicable Treasury Regulations promulgated thereunder.

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

(gg) “ Service ” shall mean the Participant’s performance of services for the Company (or any Affiliate) in the capacity of an employee, officer, consultant, independent contractor or director.

(hh) “ Share ” or “ Shares ” shall mean a share or shares of common stock, $0.01 par value per share, of the Company or such other securities or property as may become subject to Awards pursuant to an adjustment made under Section 4(c) of the Plan.

(ii) “ Stock Appreciation Right ” shall mean any right granted under Section 6(b) of the Plan.

Section 3.    Administration

(a) Power and Authority of the Committee . The Plan shall be administered by the Committee. Any Awards made to members of the Committee, however, should be authorized by a disinterested majority of the Board. Subject to the express provisions of the Plan and to applicable law and other applicable stock exchange rules, the Committee shall have full power and authority to: (i) designate Participants; (ii) determine the type or types of Awards to be granted to each Participant under the Plan; (iii) determine the number of Shares to be covered by (or the method by which payments or other rights are to be determined in connection with) each Award; (iv) determine the terms and conditions of any Award or Award Agreement; (v) amend the terms and conditions of any Award or Award Agreement and accelerate the exercisability of any Option or waive any restrictions relating to any Award; (vi) determine whether, to what extent and under what circumstances Awards may be exercised in cash, Shares, promissory notes (provided, however, that the par value of any Shares to be issued pursuant to such exercise shall be paid in the form of cash, services rendered, personal property, real property or a combination thereof and the acceptance of such promissory notes does not conflict with Section 402 of the Sarbanes-Oxley Act of 2002), other securities, other Awards or other property, or canceled, forfeited or suspended; (vii) interpret and administer the Plan and any instrument or agreement, including an Award Agreement, relating to the Plan; (viii) establish, amend, suspend or waive such rules and regulations and appoint such agents as it shall deem appropriate for the proper administration of the Plan; and (ix) make any other determination and take any other action that the Committee deems necessary or desirable for the administration of the Plan. Unless otherwise expressly provided in the Plan, all designations, determinations, interpretations and other

 

4


decisions under or with respect to the Plan or any Award or Award Agreement shall be within the sole discretion of the Committee, may be made at any time and shall be final, conclusive and binding upon any Eligible Person and any holder or beneficiary of any Award.

(b) Power and Authority of the Board . Notwithstanding anything to the contrary contained herein, the Board may, at any time and from time to time, without any further action of the Committee, exercise the powers and duties of the Committee under the Plan, but only to the extent it would not cause a loss of any benefits under Section 162(m).

Section 4.    Shares Available for Awards

(a) Shares Available . Subject to adjustment as provided in Section 4(c) of the Plan, the aggregate number of Shares that may be issued under the Plan shall be 4,000,000. Any Shares that are used by a Participant as full or partial payment to the Company of the purchase price relating to an Award, or in connection with the satisfaction of tax obligations relating to an Award, shall again be available for granting Awards (other than Incentive Stock Options) under the Plan. In addition, if any Shares covered by an Award or to which an Award relates are not purchased or are forfeited, or if an Award otherwise terminates without delivery of any Shares, then the number of Shares counted against the aggregate number of Shares available under the Plan with respect to such Award, to the extent of any such forfeiture or termination, shall again be available for granting Awards under the Plan. Notwithstanding the foregoing, (i) the number of Shares available for granting Incentive Stock Options under the Plan shall not exceed 4,000,000, subject to adjustment as provided in Section 4(c) of the Plan and subject to the provisions of Section 422 or 424 of the Code or any successor provision and (ii) the number of Shares available for granting Restricted Stock and Restricted Stock Units shall not exceed 4,000,000, subject to adjustment as provided in Section 4(c) of the Plan.

(b) Accounting for Awards . For purposes of this Section 4, if an Award entitles the holder thereof to receive or purchase Shares, the number of Shares covered by such Award or to which such Award relates shall be counted on the date of grant of such Award against the aggregate number of Shares available for granting Awards under the Plan. Any Shares that are used by a Participant as full or partial payment to the Company of the purchase price relating to an Award or in connection with the satisfaction of tax obligations relating to an Award, shall again be available for granting Awards under the Plan. In addition, if any Shares covered by an Award or to which an Award relates are not purchased or are forfeited, or if an Award otherwise terminates without delivery of any Shares, then the number of Shares counted against the aggregate number of Shares available under the Plan with respect to such Award, to the extent of any such forfeiture or termination, shall again be available for granting Awards under the Plan.

(c) Adjustments . In the event that the Committee shall determine that any dividend or other distribution (whether in the form of cash, Shares, other securities or other property), recapitalization, stock split, reverse stock split, reorganization, merger, consolidation, split-up, spin-off, combination, repurchase or exchange of Shares or other securities of the Company, issuance of warrants or other rights to purchase Shares or other securities of the Company or other similar corporate transaction or event affects the Shares such that an adjustment is determined by the Committee to be appropriate in order to prevent dilution or enlargement of the

 

5


benefits or potential benefits intended to be made available under the Plan, then the Committee shall, in such manner as it may deem equitable, adjust any or all of (i) the number and type of Shares (or other securities or other property) that thereafter may be made the subject of Awards, (ii) the number and type of Shares (or other securities or other property) subject to outstanding Awards, (iii) the purchase price or exercise price with respect to any Award and (iv) the limitations contained in Section 4(d) of the Plan; provided , however , that the number of Shares covered by any Award or to which such Award relates shall always be a whole number. Notwithstanding the forgoing, any adjustments made pursuant to this Section 4(c) shall be subject to any prior approvals as may be required of any relevant stock exchanges on which the Company’s securities are then traded or any other applicable regulatory authorities.

(d) Section 162(m) Award Limitations Under the Plan . No Eligible Person may be granted any Award or Awards under the Plan which is intended to represent “qualified performance based compensation” with the meaning of Section 162(m) of the Code, for more than 2,000,000 Shares (subject to adjustment as provided for in Section 4(c) of the Plan), in the aggregate in any taxable year.

Section 5.    Eligibility

Any Eligible Person shall be eligible to be designated a Participant. In determining which Eligible Persons shall receive an Award and the terms of any Award, the Committee may take into account the nature of the services rendered by the respective Eligible Persons, their present and potential contributions to the success of the Company or such other factors as the Committee, in its discretion, shall deem relevant. Notwithstanding the foregoing, an Incentive Stock Option may only be granted to full-time or part-time employees (which term as used herein includes, without limitation, officers and directors who are also employees), and an Incentive Stock Option shall not be granted to an employee of an Affiliate unless such Affiliate is also a “subsidiary corporation” of the Company within the meaning of Section 424(f) of the Code or any successor provision.

Section 6.    Awards

(a) Options . The Committee is hereby authorized to grant Options to Eligible Persons with the following terms and conditions and with such additional terms and conditions not inconsistent with the provisions of the Plan as the Committee shall determine:

(i) Exercise Price . The purchase price per Share purchasable under an Option shall be determined by the Committee; provided , however , that such purchase price shall not be less than 100% of the Fair Market Value of a Share on the date of grant of such Option.

(ii) Option Term . The term of each Option shall be fixed by the Committee at the time of grant, but shall not be longer than 10 years from the date of grant.

(iii) Time and Method of Exercise . The Committee shall determine the time or times at which an Option may be exercised in whole or in part and the method or methods by which, and the form or forms (including, without limitation, cash, Shares,

 

6


promissory notes ( provided , however , that the par value of any Shares to be issued pursuant to such exercise shall be paid in the form of cash, services rendered, personal property, real property or a combination thereof and the acceptance of such promissory notes does not conflict with Section 402 of the Sarbanes-Oxley Act of 2002), other securities, other Awards or other property, or any combination thereof, having a Fair Market Value on the exercise date equal to the applicable exercise price) in which, payment of the exercise price with respect thereto may be made or deemed to have been made. The Committee shall have the discretion to grant Options that are exercisable for unvested Shares. Should the Participant’s Service cease while the Shares issued upon the early exercise of the Participant’s Options are still unvested, the Company shall have the right to repurchase any or all of those unvested Shares at a price per share determined by the Committee. The terms upon which such repurchase right shall be exercisable (including the period and procedure for exercise and the appropriate vesting schedule for the purchased shares) shall be established by the Committee and set forth in the Award Agreement. Any repurchases must be made in compliance with the relevant provisions of California law.

(iv) Incentive Stock Options . Notwithstanding anything in the Plan to the contrary, the following additional provisions shall apply to the grant of stock options which are intended to qualify as Incentive Stock Options:

(A) The Committee will not grant Incentive Stock Options in which the aggregate Fair Market Value (determined as of the time the option is granted) of the Shares with respect to which Incentive Stock Options are exercisable for the first time by any Participant during any calendar year (under this Plan and all other plans of the Company and its Affiliates) shall exceed $100,000.

(B) All Incentive Stock Options must be granted within ten years from the earlier of the date on which this Plan was adopted by the Board or the date this Plan was approved by the shareholders of the Company.

(C) Unless sooner exercised, all Incentive Stock Options shall expire and no longer be exercisable no later than 10 years after the date of grant; provided , however , that in the case of a grant of an Incentive Stock Option to a Participant who, at the time such Option is granted, owns (within the meaning of Section 422 of the Code) stock possessing more than 10% of the total combined voting power of all classes of stock of the Company or of its Affiliate, such Incentive Stock Option shall expire and no longer be exercisable no later than 5 years from the date of grant.

(D) The purchase price per Share for an Incentive Stock Option shall be not less than 100% of the Fair Market Value of a Share on the date of grant of the Incentive Stock Option; provided , however , that, in the case of the grant of an Incentive Stock Option to a Participant who, at the time such Option is granted, owns (within the meaning of Section 422 of the Code) stock possessing more than 10% of the total combined voting power of all classes of stock of the Company or

 

7


of its Affiliate, the purchase price per Share purchasable under an Incentive Stock Option shall be not less than 110% of the Fair Market Value of a Share on the date of grant of the Inventive Stock Option.

(E) Any Incentive Stock Option authorized under the Plan shall contain such other provisions as the Committee shall deem advisable, but shall in all events be consistent with and contain all provisions required in order to qualify the Option as an Incentive Stock Option.

(b) Stock Appreciation Rights . The Committee is hereby authorized to grant Stock Appreciation Rights to Eligible Persons subject to the terms of the Plan and any applicable Award Agreement. Each Stock Appreciation Right granted under the Plan shall confer on the holder upon exercise the right to receive[, as determined by the Committee, cash or] a number of Shares equal to the excess of (a) the Fair Market Value of one Share on the date of exercise (or, if the Committee shall so determine, at any time during a specified period before or after the date of exercise) over (b) the grant price of the Stock Appreciation Right as determined by the Committee, which grant price shall not be less than 100% of the Fair Market Value of one Share on the date of grant of the Stock Appreciation Right. Subject to the terms of the Plan, the grant price, term, methods of exercise, dates of exercise, methods of settlement and any other terms and conditions (including conditions or restrictions on the exercise thereof) of any Stock Appreciation Right shall be as determined by the Committee.

(c) Restricted Stock and Restricted Stock Units . The Committee is hereby authorized to grant Restricted Stock and Restricted Stock Units to Eligible Persons with the following terms and conditions and with such additional terms and conditions not inconsistent with the provisions of the Plan as the Committee shall determine:

(i) Restrictions . Shares of Restricted Stock and Restricted Stock Units shall be subject to such restrictions as the Committee may impose (including, without limitation, a restriction on or prohibition against the right to receive any dividend or other right or property with respect thereto), which restrictions may lapse separately or in combination at such time or times, in such installments or otherwise as the Committee may deem appropriate.

(ii) Issuance of Shares . Any Restricted Stock granted under the Plan may be evidenced in such manner as the Board may deem appropriate, including book-entry registration or issuance of a stock certificate or certificates, which certificate or certificates shall be held by the Company. Such certificate or certificates shall be registered in the name of the Participant and shall bear an appropriate legend referring to the restrictions applicable to such Restricted Stock.

(iii) Forfeiture . Except as otherwise determined by the Committee, upon a Participant’s termination of employment or resignation or removal as a director, as the case may be (all as determined under criteria established by the Committee), during the applicable restriction period, all Shares of Restricted Stock and Restricted Stock Units at such time subject to restriction shall be forfeited and reacquired by the Company;

 

8


provided , however , that the Committee may, when it finds that a waiver would be in the best interest of the Company, waive in whole or in part any or all remaining restrictions with respect to Shares of Restricted Stock or Restricted Stock Units.

(d) Performance Awards . The Committee is hereby authorized to grant Performance Awards to Eligible Persons subject to the terms of the Plan. A Performance Award granted under the Plan (i) may be denominated or payable in cash, Shares (including, without limitation, Restricted Stock and Restricted Stock Units), other securities, other Awards or other property and (ii) shall confer on the holder thereof the right to receive payments, in whole or in part, upon the achievement of such performance goals during such performance periods as the Committee shall establish. Subject to the terms of the Plan, the performance goals to be achieved during any performance period, the length of any performance period, the amount of any Performance Award granted, the amount of any payment or transfer to be made pursuant to any Performance Award and any other terms and conditions of any Performance Award shall be determined by the Committee. From time to time, the Committee may designate an Award granted pursuant to the Plan as an award of “qualified performance-based compensation” within the meaning of Section 162(m) of the Code (a “ Qualified Performance Based Award ”). Qualified Performance Based Awards shall, to the extent required by Section 162(m), be conditioned solely on the achievement of one or more objective Performance Goals, and such Performance Goals shall be established by the Committee within the time period prescribed by, and shall otherwise comply with the requirements of, Section 162(m). The Committee shall also certify in writing that such Performance Goals have been met prior to payment of the Qualified Performance Based Awards to the extent required by Section 162(m).

(e) Dividend Equivalents . The Committee is hereby authorized to grant Dividend Equivalents to Eligible Persons under which the Participant shall be entitled to receive payments (in cash, Shares, other securities, other Awards or other property as determined in the discretion of the Committee) equivalent to the amount of cash dividends paid by the Company to holders of Shares with respect to a number of Shares determined by the Committee. Subject to the terms of the Plan, such Dividend Equivalents may have such terms and conditions as the Committee shall determine.

(f) Other Stock Grants . The Committee is hereby authorized, subject to the terms of the Plan, to grant to Eligible Persons Shares without restrictions thereon as are deemed by the Committee to be consistent with the purpose of the Plan. Subject to the terms of the Plan and any applicable Award Agreement, such Other Stock Grant may have such terms and conditions as the Committee shall determine.

(g) Other Stock-Based Awards . The Committee is hereby authorized to grant to Eligible Persons, subject to the terms of the Plan, such other Awards that are denominated or payable in, valued in whole or in part by reference to, or otherwise based on or related to, Shares (including, without limitation, securities convertible into Shares), as are deemed by the Committee to be consistent with the purpose of the Plan. Shares or other securities delivered pursuant to a purchase right granted under this Section 6(g) shall be purchased for such consideration, which may be paid by such method or methods and in such form or forms (including, without limitation, cash, Shares, promissory notes promissory notes ( provided ,

 

9


however , that the par value of any Shares to be issued pursuant to such exercise shall be paid in the form of cash, services rendered, personal property, real property or a combination thereof and the acceptance such promissory notes does not conflict with Section 402 of the Sarbanes-Oxley Act of 2002), other securities, other Awards or other property or any combination thereof), as the Committee shall determine, the value of which consideration, as established by the Committee, shall not be less than 100% of the Fair Market Value of such Shares or other securities as of the date such purchase right is granted.

(h) General .

(i) Consideration for Awards . Awards may be granted for no cash consideration or for any cash or other consideration as determined by the Committee and required by applicable law and any applicable stock exchange rules.

(ii) Awards May Be Granted Separately or Together . Awards may, in the discretion of the Committee, be granted either alone or in addition to, in tandem with or in substitution for any other Award or any award granted under any plan of the Company or any Affiliate. Awards granted in addition to or in tandem with other Awards or in addition to or in tandem with awards granted under any such other plan of the Company or any Affiliate may be granted either at the same time as or at a different time from the grant of such other Awards or awards.

(iii) Forms of Payment under Awards . Subject to the terms of the Plan and of any applicable Award Agreement, payments or transfers to be made by the Company or an Affiliate upon the grant, exercise or payment of an Award may be made in such form or forms as the Committee shall determine (including, without limitation, cash, Shares, promissory notes ( provided , however , that the acceptance of such promissory notes does not conflict with Section 402 of the Sarbanes-Oxley Act of 2002), other securities, other Awards or other property or any combination thereof), and may be made in a single payment or transfer, in installments or on a deferred basis, in each case in accordance with rules and procedures established by the Committee. Such rules and procedures may include, without limitation, provisions for the payment or crediting of reasonable interest on installment or deferred payments or the grant or crediting of Dividend Equivalents with respect to installment or deferred payments.

(iv) Limits on Transfer of Awards . No Award (other than Other Stock Grants) and no right under any such Award shall be transferable by a Participant other than by will or by the laws of descent and distribution and the Company shall not be required to recognize any attempted assignment of such rights by any Participant; provided , however , that, if so determined by the Committee, a Participant may, in the manner established by the Committee, designate a beneficiary or beneficiaries to exercise the rights of the Participant and receive any property distributable with respect to any Award upon the death of the Participant; provided , further , that, if so determined by the Committee, a Participant may, at any time that such Participant holds such Option, transfer a Non-Qualified Stock Option to any “ Family Member ” (as such term is defined in the General Instructions to Form S-8 (or any successor to such Instructions or such Form) under the

 

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Securities Act), provided that the Participant may not receive any consideration for such transfer, the Family Member may not make any subsequent transfers other than by will or by the laws of descent and distribution and the Company receives written notice of such transfer. Except as otherwise determined by the Committee, each Award (other than an Incentive Stock Option) or right under any such Award shall be exercisable during the Participant’s lifetime only by the Participant or, if permissible under applicable law, by the Participant’s guardian or legal representative. Except as otherwise determined by the Committee, no Award (other than an Incentive Stock Option) or right under any such Award may be pledged, alienated, attached or otherwise encumbered, and any purported pledge, alienation, attachment or other encumbrance thereof shall be void and unenforceable against the Company or any Affiliate.

(v) Black-Out Periods . Except for Incentive Stock Options issued pursuant to Section 6(a)(iv), if an Award expires during, or within five business days after, a trading black-out period imposed by the Company to restrict trades in the Company’s securities, then, notwithstanding any other provision of the Plan, the Award shall expire ten business days after the trading black-out period is lifted by the Company.

(vi) Term of Awards . Subject to Sections 6(a)(iv)(C) and 6(h)(v), the term of each Award shall be fixed by the Committee at the time of grant, but shall not be longer than 10 years from the date of grant.

(vii) Restrictions; Securities Exchange Listing . All Shares or other securities delivered under the Plan pursuant to any Award or the exercise thereof shall be subject to such stop transfer orders and other restrictions as the Committee may deem advisable under the Plan, applicable federal or state securities laws and regulatory requirements, and the Committee may direct appropriate stop transfer orders and cause other legends to be placed on the certificates for such Shares or other securities to reflect such restrictions. If the Shares or other securities are traded on a securities exchange, the Company shall not be required to deliver any Shares or other securities covered by an Award unless and until such Shares or other securities have been and continue to be admitted for trading on such securities exchange. No Shares or other assets shall be issued or delivered pursuant to the Plan unless and until there shall have been compliance with all applicable requirements of applicable securities laws, including the filing and effectiveness of the Form S-8 registration statement for the Shares issuable pursuant to the Plan, and all applicable listing requirements of any stock exchange or trading system on which Common Stock is then traded, including the American Stock Exchange and the Toronto Stock Exchange. No Shares shall be issued or delivered pursuant to the Plan if doing so would violate any internal policies of the Company.

(viii) Prohibition on Repricing . Except as provided in Section 4(c) of the Plan, no Option or Stock Appreciation Right may be amended to reduce its initial exercise or grant price and no Option or Stock Appreciation Right shall be canceled and replaced with Options or Stock Appreciation Rights having a lower exercise or grant price, without the approval of the shareholders of the Company.

 

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Section 7.    Amendment and Termination; Adjustments

(a) Amendments to the Plan . The Board may amend, alter, suspend, discontinue or terminate the Plan at any time; provided , however , that, notwithstanding any other provision of the Plan or any Award Agreement, without the approval of the shareholders of the Company, no such amendment, alteration, suspension, discontinuation or termination shall be made that, absent such approval:

(i) violates the rules or regulations of the National Association of Securities Dealers, Inc. or any other securities exchange that are applicable to the Company;

(ii) causes the Company to be unable, under the Code, to grant Incentive Stock Options under the Plan;

(iii) increases the number of shares authorized under the Plan as specified in Section 4(a);

(iv) permits the award of Options or Stock Appreciation Rights at a price less than 100% of the Fair Market Value of a Share on the date of grant of such Option or Stock Appreciation Right, as prohibited by Sections 6(a)(i) and 6(b) of the Plan or the repricing of Options or Stock Appreciation Rights, as prohibited by Section 6(h)(vii) of the Plan;

(v) would prevent the grant of Options or Stock Appreciation Rights that would qualify under Section 162(m) of the Code; or

(vi) increase the aggregate number of Common Shares in respect of which Awards have been granted and remain outstanding so as to result in: (A) the number of Common Shares reserved for issuance to Insiders pursuant to Awards exceeding 10% of the issued and outstanding Common Shares or (B) the issuance to Insiders pursuant to Awards, within a one-year period, of a number of Common Shares exceeding 10% of the issued and outstanding Common Shares.

(b) Amendments to Awards . The Committee may waive any conditions of or rights of the Company under any outstanding Award, prospectively or retroactively. Except as otherwise provided herein or in an Award Agreement, the Committee may not amend, alter, suspend, discontinue or terminate any outstanding Award, prospectively or retroactively, if such action would adversely affect the rights of the holder of such Award, without the consent of the Participant or holder or beneficiary thereof. Notwithstanding the foregoing, the Committee shall not waive any conditions or rights of the Company, or otherwise amend or alter any outstanding Qualified Performance Based Award in such a manner as to cause such Award not to constitute “qualified performance based compensation” within the meaning of Section 162(m) of the Code. Notwithstanding the forgoing, no amendments shall be made to any granted Awards to (i) reduce the exercise price of Option, or cancel and reissue any Options so as to in effect reduce the exercise price of Options, for the benefit of Insiders or (ii) extend the termination date beyond the original expiration date for the benefit of Insiders without first obtaining approval of the shareholders in accordance with the requirements of applicable stock exchange rules; and no

 

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action shall be taken with respect to granted Options without the consent of the optionee, unless the Board determines that such action does not materially alter or impair such Option.

(c) Correction of Defects, Omissions and Inconsistencies . The Committee may correct any defect, supply any omission or reconcile any inconsistency in the Plan or in any Award or Award Agreement in the manner and to the extent it shall deem desirable to implement or maintain the effectiveness of the Plan.

Section 8.    Income Tax Withholding

In order to comply with all applicable federal, state or local income tax laws or regulations, the Company may take such action as it deems appropriate to ensure that all applicable federal, state or local payroll, withholding, income or other taxes, which are the sole and absolute responsibility of a Participant, are withheld or collected from such Participant. In order to assist a Participant in paying all or a portion of the federal, state and local taxes to be withheld or collected upon exercise or receipt of (or the lapse of restrictions relating to) an Award, the Committee, in its discretion and subject to such additional terms and conditions as it may adopt, may permit the Participant to satisfy such tax obligation by (i) electing to have the Company withhold a portion of the Shares otherwise to be delivered upon exercise or receipt of (or the lapse of restrictions relating to) such Award with a Fair Market Value equal to the amount of such taxes (but only to the extent of the minimum amount required to be withheld under applicable laws or regulations) or (ii) delivering to the Company Shares other than Shares issuable upon exercise or receipt of (or the lapse of restrictions relating to) such Award with a Fair Market Value equal to the amount of such taxes (but only to the extent of the minimum amount required to be withheld under applicable laws or regulations). The election, if any, must be made on or before the date that the amount of tax to be withheld is determined.

Section 9.    General Provisions

(a) No Rights to Awards . No Eligible Person or other Person shall have any claim to be granted any Award under the Plan, and there is no obligation for uniformity of treatment of Eligible Persons or holders or beneficiaries of Awards under the Plan. The terms and conditions of Awards need not be the same with respect to any Participant or with respect to different Participants.

(b) Award Agreements . No Participant will have rights under an Award granted to such Participant unless and until an Award Agreement shall have been duly executed on behalf of the Company and, if requested by the Company, signed by the Participant.

(c) Plan Provisions Control . In the event that any provision of an Award Agreement conflicts with or is inconsistent in any respect with the terms of the Plan as set forth herein or subsequently amended, the terms of the Plan shall control.

(d) No Rights of Shareholders . Except with respect to Shares of Restricted Stock as to which the Participant has been granted the right to vote, neither a Participant nor the Participant’s legal representative shall be, or have any of the rights and privileges of, a shareholder of the Company with respect to any Shares issuable to such Participant upon the

 

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exercise or payment of any Award, in whole or in part, unless and until such Shares have been issued in the name of such Participant or such Participant’s legal representative without restrictions thereto.

(e) No Limit on Other Compensation Arrangements . Nothing contained in the Plan shall prevent the Company or any Affiliate from adopting or continuing in effect other or additional compensation arrangements, and such arrangements may be either generally applicable or applicable only in specific cases.

(f) No Right to Employment . The grant of an Award shall not be construed as giving a Participant the right to be retained in the employ, or as giving a director of the Company or an Affiliate the right to continue as a director or an Affiliate of the Company or any Affiliate, nor will it affect in any way the right of the Company or an Affiliate to terminate a Participant’s employment or service at any time, with or without cause. In addition, the Company or an Affiliate may at any time dismiss a Participant from employment, or terminate the term of a director of the Company or an Affiliate, free from any liability or any claim under the Plan or any Award, unless otherwise expressly provided in the Plan or in any Award Agreement. Nothing in this Plan shall confer on any person any legal or equitable right against the Company or any Affiliate, directly or indirectly, or give rise to any cause of action at law or in equity against the Company or an Affiliate. The Awards granted hereunder shall not form any part of the wages or salary of any Eligible Person for purposes of severance pay or termination indemnities, irrespective of the reason for termination of employment. Under no circumstances shall any person ceasing to be an employee of the Company or any Affiliate be entitled to any compensation for any loss of any right or benefit under the Plan which such employee might otherwise have enjoyed but for termination of employment, whether such compensation is claimed by way of damages for wrongful or unfair dismissal, breach of contract or otherwise. By participating in the Plan, each Participant shall be deemed to have accepted all the conditions of the Plan and the terms and conditions of any rules and regulations adopted by the Committee and shall be fully bound thereby.

(g) Governing Law . The validity, construction and effect of the Plan or any Award, and any rules and regulations relating to the Plan or any Award, shall be determined in accordance with the internal laws, and not the law of conflicts, of the State of California.

(h) Severability . If any provision of the Plan or any Award is or becomes or is deemed to be invalid, illegal or unenforceable in any jurisdiction or would disqualify the Plan or any Award under any law deemed applicable by the Committee, such provision shall be construed or deemed amended to conform to applicable laws, or if it cannot be so construed or deemed amended without, in the determination of the Committee, materially altering the purpose or intent of the Plan or the Award, such provision shall be stricken as to such jurisdiction or Award, and the remainder of the Plan or any such Award shall remain in full force and effect.

(i) No Trust or Fund Created . Neither the Plan nor any Award shall create or be construed to create a trust or separate fund of any kind or a fiduciary relationship between the Company or any Affiliate and an Eligible Person or any other Person. To the extent that any Person acquires a right to receive payments from the Company or any Affiliate pursuant to an Award, such right shall be no greater than the right of any unsecured general creditor of the Company or any Affiliate.

 

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(j) Other Benefits . No compensation or benefit awarded to or realized by any Participant under the Plan shall be included for the purpose of computing such Participant’s compensation under any compensation-based retirement, disability, or similar plan of the Company unless required by law or otherwise provided by such other plan.

(k) No Fractional Shares . No fractional Shares shall be issued or delivered pursuant to the Plan or any Award, and the Committee shall determine whether cash shall be paid in lieu of any fractional Shares or whether such fractional Shares or any rights thereto shall be canceled, terminated or otherwise eliminated.

(l) Headings . Headings are given to the Sections and subsections of the Plan solely as a convenience to facilitate reference. Such headings shall not be deemed in any way material or relevant to the construction or interpretation of the Plan or any provision thereof.

(m) Section 16 Compliance; Section 162(m) Administration . The Plan is intended to comply in all respects with Rule 16b-3 or any successor provision, as in effect from time to time, and in all events the Plan shall be construed in accordance with the requirements of Rule 16b-3. If any Plan provision does not comply with Rule 16b-3 as hereafter amended or interpreted, the provision shall be deemed inoperative. The Board of Directors, in its absolute discretion, may bifurcate the Plan so as to restrict, limit or condition the use of any provision of the Plan with respect to persons who are officers or directors subject to Section 16 of the Exchange Act without so restricting, limiting or conditioning the Plan with respect to other Eligible Persons. With respect to Options and Stock Appreciation Rights, the Company intends to have the Plan administered in accordance with the requirements for the award of “qualified performance-based compensation” within the meaning of Section 162(m) of the Code.

(n) Conditions Precedent to Issuance of Shares . Shares shall not be issued pursuant to the exercise or payment of the purchase price relating to an Award unless such exercise or payment and the issuance and delivery of such Shares pursuant thereto shall comply with all relevant provisions of law, including, without limitation, the Securities Act, the Exchange Act, the rules and regulations promulgated thereunder, applicable Canadian securities laws, the requirements of any applicable stock exchange and the California General Corporation Law. As a condition to the exercise or payment of the purchase price relating to such Award, the Company may require that the person exercising or paying the purchase price represent and warrant that the Shares are being purchased only for investment and without any present intention to sell or distribute such Shares if, in the opinion of counsel for the Company, such a representation and warranty is required by law.

Section 10.    Effective Date of the Plan

The Plan shall be effective upon the effective date of the Company’s registration statement on Form S-1 in connection with the Company’s initial public offering of its common stock.

 

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Section 11.    Term of the Plan

No Award shall be granted under the Plan after (a) the tenth anniversary of the earlier of (i) the date on which this Plan was adopted by the Board or (ii) the date this Plan was approved by the shareholders of the Company, or (b) any earlier date of discontinuation or termination established pursuant to Section 7(a) of the Plan. However, unless otherwise expressly provided in the Plan or in an applicable Award Agreement, any Award theretofore granted may extend beyond such date, and the authority of the Committee provided for hereunder with respect to the Plan and any Awards, and the authority of the Board to amend the Plan, shall extend beyond the termination of the Plan.

 

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NOVABAY PHARMACEUTICALS, INC.

INCENTIVE STOCK OPTION AGREEMENT

This INCENTIVE STOCK OPTION AGREEMENT (the “ Agreement ”) is made this              day of              ,              , by and between NovaBay Pharmaceuticals, Inc., a California corporation (the “ Company ”), and              , an individual resident of              ,              (“ Optionee ”).

1. Grant of Option . The Company hereby grants Optionee the option (the “ Option ”) to purchase all or any part of an aggregate of              shares (the “ Shares ”) of common stock, $0.01 par value (“ Common Stock ”), of the Company at the exercise price of $              per share according to the terms and conditions set forth in this Agreement and in the NovaBay Pharmaceuticals, Inc. 2007 Omnibus Incentive Plan (the “ Plan ”). The Option will be treated as an incentive stock option within the meaning of Section 422 of the Internal Revenue Code of 1986, as amended (the “ Code ”). The Option is issued under the Plan and is subject to its terms and conditions. A copy of the Plan will be furnished upon request of Optionee.

The Option shall terminate at the close of business ten (10) years from the date hereof; provided , however , that if Optionee owns (within the meaning of Section 422 of the Code) as of the date hereof stock possessing more than 10% of the total combined voting power of all classes of stock of the Company or of its Affiliates, the Option shall terminate at the close of business five (5) years from the date hereof.

2. Vesting of Option Rights .

(a) Except as otherwise provided in this Agreement, the Option may be exercised by Optionee in accordance with the following schedule:

 

On or after each of

the following dates

   Number of Shares
with respect to which the Option is exercisable
  
  
  
  
  

(b) During the lifetime of Optionee, the Option shall be exercisable only by Optionee and shall not be assignable or transferable by Optionee, other than by will or the laws of descent and distribution.

(c) Optionee understands that to the extent that the aggregate fair market value (determined at the time the option was granted) of the shares of Common Stock of the Company with respect to which all options that are incentive stock options within the meaning of Section 422 of the Code are exercisable for the first time by Optionee during any calendar year exceed $100,000, in accordance with Section 422(d) of the Code, such options shall be treated as options that do not qualify as incentive stock options.


3. Exercise of Option after Death or Termination of Employment or Service . The Option shall terminate and may no longer be exercised if Optionee ceases to be employed by or provide Service to the Company or its Affiliates, except that:

(a) If Optionee’s employment or Service shall be terminated for any reason, voluntary or involuntary, other than for “ Misconduct ” (as defined in Section 3(e)) or Optionee’s death or Permanent Disability (as defined in the Plan and within the meaning of Section 22(e)(3) of the Internal Revenue Code of 1986, as amended), Optionee may at any time within a period of three (3) months after such termination exercise the Option to the extent the Option was exercisable by Optionee on the date of the termination of Optionee’s employment or Service.

(b) If Optionee’s employment or Service is terminated for Misconduct, the Option shall be terminated as of the date of the act giving rise to such termination.

(c) If Optionee shall die while the Option is still exercisable according to its terms, or if employment or Service is terminated because of Optionee’s Permanent Disability while in the employ of the Company, and Optionee shall not have fully exercised the Option, such Option may be exercised, at any time within twelve (12) months after Optionee’s death or date of termination of employment or Service for Permanent Disability, by Optionee, personal representatives or administrators or guardians of Optionee, as applicable, or by any person or persons to whom the Option is transferred by will or the applicable laws of descent and distribution, to the extent of the full number of Shares Optionee was entitled to purchase under the Option on (i) the earlier of the date of death or termination of employment or Service or (ii) the date of termination for such Permanent Disability, as applicable.

(d) Notwithstanding the above, in no case may the Option be exercised to any extent by anyone after the termination date of the Option.

(e) “ Misconduct ” shall mean (i) the commission of any act of fraud, embezzlement or dishonesty by Optionee, (ii) any unauthorized use or disclosure by such person of confidential information or trade secrets of the Company (or of any Affiliate), or (iii) any other intentional misconduct by such person adversely affecting the business or affairs of the Company (or any Affiliate) in a material manner. However, if the term or concept has been defined in an employment agreement between the Company and Optionee, then Misconduct shall have the definition set forth in such employment agreement. The foregoing definition shall not in any way preclude or restrict the right of the Company (or any Affiliate) to discharge or dismiss any Optionee or other person in the Service of the Company (or any Affiliate) for any other acts or omissions but such other acts or omissions shall not be deemed, for purposes of the Agreement, to constitute grounds for termination for Misconduct.

4. Method of Exercise of Option . Subject to the foregoing, the Option may be exercised in whole or in part from time to time by serving written notice of exercise on the Company at its principal office within the Option period. The notice shall state the number of Shares as to which the Option is being exercised and shall be accompanied by payment of the

 

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exercise price. Payment of the exercise price shall be made (i) in cash (including bank check, personal check or money order payable to the Company), (ii) with the approval of the Company (which may be given in its sole discretion), by delivering to the Company for cancellation shares of the Company’s Common Stock already owned by Optionee having a Fair Market Value equal to the full exercise price of the Shares being acquired, (iii) with the approval of the Company (which may be given in its sole discretion) and subject to Section 402 of the Sarbanes-Oxley Act of 2002, by delivering to the Company the full exercise price of the Shares being acquired in a combination of cash and Optionee’s full recourse liability promissory note with a principal amount not to exceed eighty percent (80%) of the exercise price and a term not to exceed five (5) years, which promissory note shall provide for interest on the unpaid balance thereof which at all times is not less than the minimum rate required to avoid the imputation of income, original issue discount or a below-market rate loan pursuant to Sections 483, 1274 or 7872 of the Code or any successor provisions thereto, (iv) subject to Section 402 of the Sarbanes-Oxley Act of 2002, to the extent this Option is exercised for vested shares, through a special sale and remittance procedure pursuant to which Optionee shall concurrently provide irrevocable instructions (1) to Optionee’s brokerage firm to effect the immediate sale of the purchased Shares and remit to the Company, out of the sale proceeds available on the settlement date, sufficient funds to cover the aggregate exercise price payable for the purchased Shares plus all applicable income and employment taxes required to be withheld by the Company by reason of such exercise and (2) to the Company to deliver the certificates for the purchased shares directly to such brokerage firm in order to complete the sale, or (v) with the approval of the Company (which may be given in its sole discretion) and subject to Section 402 of the Sarbanes-Oxley Act of 2002, by delivering to the Company a combination of any of the forms of payment described above. This Option may be exercised only with respect to full shares and no fractional share of stock shall be issued.

5. Change in Control .

(a) If this Option is assumed in connection with a Change in Control or otherwise continued in effect, then this Option shall be appropriately adjusted, immediately after such Change in Control, to apply to the number and class of securities which would have been issuable to Optionee in consummation of such Change in Control had the option been exercised immediately prior to such Change in Control, and appropriate adjustments shall also be made to the exercise price, provided the aggregate exercise price shall remain the same. To the extent that the actual holders of the Company’s outstanding Common Stock receive cash consideration for their Common Stock in consummation of the Change in Control, the successor corporation may, in connection with the assumption of this Option, substitute one or more shares of its own common stock with a fair market value equivalent to the cash consideration paid per share of Common Stock in such Change in Control.

(b) This Agreement shall not in any way affect the right of the Company to adjust, reclassify, reorganize or otherwise change its capital or business structure or to merge, consolidate, dissolve, liquidate or sell or transfer all or any part of its business or assets.

 

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(c) For purposes of this Agreement, “ Change in Control ” shall mean a change in ownership or control of the Company effected through any of the following transactions:

(i) a merger, consolidation or other reorganization unless securities representing more than 50% of the total combined voting power of the voting securities of the successor corporation are immediately thereafter beneficially owned, directly or indirectly and in substantially the same proportion, by the persons who beneficially owned the Company’s outstanding voting securities immediately prior to such transaction; (ii) the sale, transfer or other disposition of all or substantially all of the Company’s assets; or (iii) the acquisition, directly or indirectly by any person or related group of persons (other than the Company or a person that directly or indirectly controls, is controlled by, or is under common control with, the Company), of beneficial ownership (within the meaning of Rule 13d-3 of the Exchange Act) of securities possessing more than 50% of the total combined voting power of the Company’s outstanding securities pursuant to a tender or exchange offer made directly to the Company’s shareholders.

6. Capital Adjustments and Reorganization . Should any change be made to the Common Stock by reason of any stock split, reverse stock split, stock dividend, recapitalization, combination of shares, exchange of shares or other change affecting the outstanding Common Stock as a class without the Company’s receipt of consideration, appropriate adjustments shall be made to (a) the number and/or class of securities subject to this Option and (b) the exercise price in order to reflect such change and thereby preclude a dilution or enlargement of benefits hereunder.

7. Miscellaneous .

(a) Entire Agreement; Plan Provisions Control . This Agreement (and any addendum hereto) and the Plan constitute the entire agreement between the parties hereto with regard to the subject matter hereof. In the event that any provision of the Agreement conflicts with or is inconsistent in any respect with the terms of the Plan, the terms of the Plan shall control. All decisions of the Committee with respect to any question or issue arising under the Plan or this Agreement shall be and binding on all persons having an interest in this Option. All capitalized terms used in this Agreement and not otherwise defined in this Agreement shall have the meaning assigned to them in the Plan.

(b) No Rights of Shareholders . Neither Optionee, Optionee’s legal representative nor a permissible assignee of this Option shall have any of the rights and privileges of a shareholder of the Company with respect to the Shares, unless and until such Shares have been issued in the name of Optionee, Optionee’s legal representative or permissible assignee, as applicable, without restrictions thereto.

(c) No Right to Employment . The grant of the Option shall not be construed as giving Optionee the right to be retained in the employ of, or if Optionee is a director of the Company or an Affiliate as giving the Optionee the right to continue as a director of, the Company or an Affiliate, nor will it affect in any way the right of the Company or an Affiliate to terminate such employment or position at any time, with or without cause. In addition, the Company or an Affiliate may at any time dismiss Optionee from employment, or terminate the term of a director of the Company or an Affiliate, free from any liability or any claim under the Plan or the Agreement. Nothing in the Agreement shall confer on any person any legal or equitable right against the Company or any Affiliate, directly or indirectly, or give rise to any

 

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cause of action at law or in equity against the Company or an Affiliate. The Option granted hereunder shall not form any part of the wages or salary of Optionee for purposes of severance pay or termination indemnities, irrespective of the reason for termination of employment. Under no circumstances shall any person ceasing to be an employee of the Company or any Affiliate be entitled to any compensation for any loss of any right or benefit under the Agreement or Plan which such employee might otherwise have enjoyed but for termination of employment, whether such compensation is claimed by way of damages for wrongful or unfair dismissal, breach of contract or otherwise. By participating in the Plan, Optionee shall be deemed to have accepted all the conditions of the Plan and the Agreement and the terms and conditions of any rules and regulations adopted by the Committee and shall be fully bound thereby.

(d) Governing Law . The validity, construction and effect of the Plan and the Agreement, and any rules and regulations relating to the Plan and the Agreement, shall be determined in accordance with the internal laws, and not the law of conflicts, of the State of California.

(e) Severability . If any provision of the Agreement is or becomes or is deemed to be invalid, illegal or unenforceable in any jurisdiction or would disqualify the Agreement under any law deemed applicable by the Committee, such provision shall be construed or deemed amended to conform to applicable laws, or if it cannot be so construed or deemed amended without, in the determination of the Committee, materially altering the purpose or intent of the Plan or the Agreement, such provision shall be stricken as to such jurisdiction or the Agreement, and the remainder of the Agreement shall remain in full force and effect.

(f) No Trust or Fund Created . Neither the Plan nor the Agreement shall create or be construed to create a trust or separate fund of any kind or a fiduciary relationship between the Company or any Affiliate and Optionee or any other person.

(g) Headings . Headings are given to the Sections and subsections of the Agreement solely as a convenience to facilitate reference. Such headings shall not be deemed in any way material or relevant to the construction or interpretation of the Agreement or any provision thereof.

(h) Notices . Any notice required to be given or delivered to the Company under the terms of this Agreement shall be addressed to the Company at its principal corporate offices. Any notice required to be given or delivered to Optionee shall be addressed to Optionee at the address indicated below Optionee’s signature line at the end of this Agreement or at such other address as Optionee may designate by ten (10) days’ advance written notice to the Company. Any notice required to be given under this Agreement shall be in writing and shall be deemed effective upon personal delivery or upon the third (3rd) day following deposit in the U.S. mail, registered or certified, postage prepaid and properly addressed to the party entitled to such notice.

(i) Conditions Precedent to Issuance of Shares . Shares shall not be issued pursuant to the exercise of the Option unless such exercise and the issuance and delivery of the applicable Shares pursuant thereto shall comply with all relevant provisions of law, including, without limitation, the Securities Act of 1933, as amended, the Exchange Act of 1934, as amended, the

 

5


rules and regulations promulgated thereunder, state blue sky laws, the requirements of any applicable stock exchange and the California General Corporation Law. As a condition to the exercise of the purchase price relating to the Option, the Company may require that the person exercising or paying the purchase price represent and warrant that the Shares are being purchased only for investment and without any present intention to sell or distribute such Shares if, in the opinion of counsel for the Company, such a representation and warranty is required by law.

(j) Withholding . If Optionee shall dispose of any of the shares of Common Stock acquired upon exercise of the Option within two (2) years from the date the Option was granted or within one (1) year after the date of exercise of the Option, then, in order to provide the Company with the opportunity to claim the benefit of any income tax deduction, Optionee shall promptly notify the Company of the dates of acquisition and disposition of such shares, the number of shares so disposed of, and the consideration, if any, received for such shares. In order to comply with all applicable federal or state income tax laws or regulations, the Company may take such action as it deems appropriate to assure (i) notice to the Company of any disposition of the shares of the Company within the time periods described above, and (ii) that, if necessary, all applicable federal or state payroll, withholding, income or other taxes are withheld or collected from Optionee.

(k) Consultation With Professional Tax and Investment Advisors . Optionee acknowledges that the grant, exercise and vesting with respect to this Option, and the sale or other taxable disposition of the Shares, may have tax consequences pursuant to the Code or under local, state or international tax laws. Optionee further acknowledges that Optionee is relying solely and exclusively on Optionee’s own professional tax and investment advisors with respect to any and all such matters (and is not relying, in any manner, on the Company or any of its employees or representatives). Optionee understands and agrees that any and all tax consequences resulting from the Option and its grant, exercise and vesting, and the sale or other taxable disposition of the Shares, is solely and exclusively the responsibility of Optionee without any expectation or understanding that the Company or any of its employees or representatives will pay or reimburse Optionee for such taxes or other items.

[SIGNATURE PAGE FOLLOWS]

 

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IN WITNESS WHEREOF , the Company and Optionee have executed this Agreement on the date set forth in the first paragraph.

 

NOVABAY PHARMACEUTICALS, INC.
By:      
Name:       
Title:       
OPTIONEE:
By:      
Name:       
Address:       
   
Facsimile:       

 

7


NOVABAY PHARMACEUTICALS, INC.

NON-INCENTIVE STOCK OPTION AGREEMENT

This NON-INCENTIVE STOCK OPTION AGREEMENT (the “ Agreement ”) is made this              day of              ,              , by and between NovaBay Pharmaceuticals, Inc., a California corporation (the “ Company ”), and              , an individual resident of              ,              (“ Optionee ”).

1. Grant of Option . The Company hereby grants Optionee the option (the “ Option ”) to purchase all or any part of an aggregate of              shares (the “ Shares ”) of common stock, $0.01 par value (“ Common Stock ”), of the Company at the exercise price of $              per share according to the terms and conditions set forth in this Agreement and in the NovaBay Pharmaceuticals, Inc. 2007 Omnibus Incentive Plan (the “ Plan ”). The Option will not be treated as an incentive stock option within the meaning of Section 422 of the Internal Revenue Code of 1986, as amended (the “ Code ”). The Option is issued under the Plan and is subject to its terms and conditions. A copy of the Plan will be furnished upon request of Optionee.

The Option shall terminate at the close of business ten (10) years from the date hereof.

2. Vesting of Option Rights .

(a) Except as otherwise provided in this Agreement, the Option may be exercised by Optionee in accordance with the following schedule:

 

On or after each of

the following dates

  

Number of Shares

with respect to which

the Option is exercisable

  
  
  
  
  

(b) During the lifetime of Optionee, the Option shall be exercisable only by Optionee and shall not be assignable or transferable by Optionee, other than by will or the laws of descent and distribution. Notwithstanding the foregoing, Optionee may transfer the Option to any Family Member (as such term is defined in the General Instructions to Form S-8 (or successor to such Instructions or such Form)); provided , however , that (i) Optionee may not receive any consideration for such transfer, (ii) the Family Member must agree in writing not to make any subsequent transfers of the Option other than by will or the laws of the descent and distribution and (iii) the Company receives prior written notice of such transfer.


3. Exercise of Option after Death or Termination of Employment or Service . The Option shall terminate and may no longer be exercised if Optionee ceases to be employed by or provide Service to the Company or its Affiliates, except that:

(a) If Optionee’s employment or Service shall be terminated for any reason, voluntary or involuntary, other than for “ Misconduct ” (as defined in Section 3(e)) or Optionee’s death or Permanent Disability, Optionee may at any time within a period of three (3) months after such termination exercise the Option to the extent the Option was exercisable by Optionee on the date of the termination of Optionee’s employment or Service.

(b) If Optionee’s employment or Service is terminated for Misconduct, the Option shall be terminated as of the date of the act giving rise to such termination.

(c) If Optionee shall die while the Option is still exercisable according to its terms, or if employment or Service is terminated because of Optionee’s Permanent Disability while in the employ of the Company, and Optionee shall not have fully exercised the Option, such Option may be exercised, at any time within twelve (12) months after Optionee’s death or date of termination of employment or Service for Permanent Disability, by Optionee, personal representatives or administrators or guardians of Optionee, as applicable, or by any person or persons to whom the Option is transferred by will or the applicable laws of descent and distribution, to the extent of the full number of Shares Optionee was entitled to purchase under the Option on (i) the earlier of the date of death or termination of employment or Service or (ii) the date of termination for such Permanent Disability, as applicable.

(d) Notwithstanding the above, in no case may the Option be exercised to any extent by anyone after the termination date of the Option.

(e) “ Misconduct ” shall mean (i) the commission of any act of fraud, embezzlement or dishonesty by Optionee, (ii) any unauthorized use or disclosure by such person of confidential information or trade secrets of the Company (or of any Affiliate), or (iii) any other intentional misconduct by such person adversely affecting the business or affairs of the Company (or any Affiliate) in a material manner. However, if the term or concept has been defined in an employment agreement between the Company and Optionee, then Misconduct shall have the definition set forth in such employment agreement. The foregoing definition shall not in any way preclude or restrict the right of the Company (or any Affiliate) to discharge or dismiss any Optionee or other person in the Service of the Company (or any Affiliate) for any other acts or omissions but such other acts or omissions shall not be deemed, for purposes of the Agreement, to constitute grounds for termination for Misconduct.

4. Method of Exercise of Option . Subject to the foregoing, the Option may be exercised in whole or in part from time to time by serving written notice of exercise on the Company at its principal office within the Option period. The notice shall state the number of Shares as to which the Option is being exercised and shall be accompanied by payment of the exercise price. Payment of the exercise price shall be made (i) in cash (including bank check, personal check or money order payable to the Company), (ii) with the approval of the Company (which may be given in its sole discretion), by delivering to the Company for cancellation shares of the Company’s Common Stock already owned by Optionee having a Fair Market Value equal to the full exercise price of the Shares being acquired, (iii) with the approval of the Company

 

2


(which may be given in its sole discretion) and subject to Section 402 of the Sarbanes-Oxley Act of 2002, by delivering to the Company the full exercise price of the Shares being acquired in a combination of cash and Optionee’s full recourse liability promissory note with a principal amount not to exceed eighty percent (80%) of the exercise price and a term not to exceed five (5) years, which promissory note shall provide for interest on the unpaid balance thereof which at all times is not less than the minimum rate required to avoid the imputation of income, original issue discount or a below-market rate loan pursuant to Sections 483, 1274 or 7872 of the Code or any successor provisions thereto, (iv) subject to Section 402 of the Sarbanes-Oxley Act of 2002, to the extent this Option is exercised for vested shares, through a special sale and remittance procedure pursuant to which Optionee shall concurrently provide irrevocable instructions (1) to Optionee’s brokerage firm to effect the immediate sale of the purchased Shares and remit to the Company, out of the sale proceeds available on the settlement date, sufficient funds to cover the aggregate exercise price payable for the purchased Shares plus all applicable income and employment taxes required to be withheld by the Company by reason of such exercise and (2) to the Company to deliver the certificates for the purchased shares directly to such brokerage firm in order to complete the sale, or (v) with the approval of the Company (which may be given in its sole discretion) and subject to Section 402 of the Sarbanes-Oxley Act of 2002, by delivering to the Company a combination of any of the forms of payment described above. This Option may be exercised only with respect to full shares and no fractional share of stock shall be issued.

5. Change in Control .

(a) If this Option is assumed in connection with a Change in Control or otherwise continued in effect, then this Option shall be appropriately adjusted, immediately after such Change in Control, to apply to the number and class of securities which would have been issuable to Optionee in consummation of such Change in Control had the option been exercised immediately prior to such Change in Control, and appropriate adjustments shall also be made to the exercise price, provided the aggregate exercise price shall remain the same. To the extent that the actual holders of the Company’s outstanding Common Stock receive cash consideration for their Common Stock in consummation of the Change in Control, the successor corporation may, in connection with the assumption of this Option, substitute one or more shares of its own common stock with a fair market value equivalent to the cash consideration paid per share of Common Stock in such Change in Control.

(b) This Agreement shall not in any way affect the right of the Company to adjust, reclassify, reorganize or otherwise change its capital or business structure or to merge, consolidate, dissolve, liquidate or sell or transfer all or any part of its business or assets.

(c) For purposes of this Agreement, “ Change in Control ” shall mean a change in ownership or control of the Company effected through any of the following transactions: (i) a merger, consolidation or other reorganization unless securities representing more than 50% of the total combined voting power of the voting securities of the successor corporation are immediately thereafter beneficially owned, directly or indirectly and in substantially the same proportion, by the persons who beneficially owned the Company’s outstanding voting securities immediately prior to such transaction; (ii) the sale, transfer

 

3


or other disposition of all or substantially all of the Company’s assets; or (iii) the acquisition, directly or indirectly by any person or related group of persons (other than the Company or a person that directly or indirectly controls, is controlled by, or is under common control with, the Company), of beneficial ownership (within the meaning of Rule 13d-3 of the Exchange Act) of securities possessing more than 50% of the total combined voting power of the Company’s outstanding securities pursuant to a tender or exchange offer made directly to the Company’s shareholders.

6. Capital Adjustments and Reorganization . Should any change be made to the Common Stock by reason of any stock split, reverse stock split, stock dividend, recapitalization, combination of shares, exchange of shares or other change affecting the outstanding Common Stock as a class without the Company’s receipt of consideration, appropriate adjustments shall be made to (a) the number and/or class of securities subject to this Option and (b) the exercise price in order to reflect such change and thereby preclude a dilution or enlargement of benefits hereunder.

7. Miscellaneous .

(a) Entire Agreement; Plan Provisions Control . This Agreement (and any addendum hereto) and the Plan constitute the entire agreement between the parties hereto with regard to the subject matter hereof. In the event that any provision of the Agreement conflicts with or is inconsistent in any respect with the terms of the Plan, the terms of the Plan shall control. All decisions of the Committee with respect to any question or issue arising under the Plan or this Agreement shall be and binding on all persons having an interest in this Option. All capitalized terms used in this Agreement and not otherwise defined in this Agreement shall have the meaning assigned to them in the Plan.

(b) No Rights of Shareholders . Neither Optionee, Optionee’s legal representative nor a permissible assignee of this Option shall have any of the rights and privileges of a shareholder of the Company with respect to the Shares, unless and until such Shares have been issued in the name of Optionee, Optionee’s legal representative or permissible assignee, as applicable, without restrictions thereto.

(c) No Right to Employment . The grant of the Option shall not be construed as giving Optionee the right to be retained in the employ of, or if Optionee is a director of the Company or an Affiliate as giving the Optionee the right to continue as a director of, the Company or an Affiliate, nor will it affect in any way the right of the Company or an Affiliate to terminate such employment or position at any time, with or without cause. In addition, the Company or an Affiliate may at any time dismiss Optionee from employment, or terminate the term of a director of the Company or an Affiliate, free from any liability or any claim under the Plan or the Agreement. Nothing in the Agreement shall confer on any person any legal or equitable right against the Company or any Affiliate, directly or indirectly, or give rise to any cause of action at law or in equity against the Company or an Affiliate. The Option granted hereunder shall not form any part of the wages or salary of Optionee for purposes of severance pay or termination indemnities, irrespective of the reason for termination of employment. Under no circumstances shall any person ceasing to be an employee of the Company or any Affiliate be entitled to any compensation for any loss of any right or benefit under the Agreement or Plan

 

4


which such employee might otherwise have enjoyed but for termination of employment, whether such compensation is claimed by way of damages for wrongful or unfair dismissal, breach of contract or otherwise. By participating in the Plan, Optionee shall be deemed to have accepted all the conditions of the Plan and the Agreement and the terms and conditions of any rules and regulations adopted by the Committee and shall be fully bound thereby.

(d) Governing Law . The validity, construction and effect of the Plan and the Agreement, and any rules and regulations relating to the Plan and the Agreement, shall be determined in accordance with the internal laws, and not the law of conflicts, of the State of California.

(e) Severability . If any provision of the Agreement is or becomes or is deemed to be invalid, illegal or unenforceable in any jurisdiction or would disqualify the Agreement under any law deemed applicable by the Committee, such provision shall be construed or deemed amended to conform to applicable laws, or if it cannot be so construed or deemed amended without, in the determination of the Committee, materially altering the purpose or intent of the Plan or the Agreement, such provision shall be stricken as to such jurisdiction or the Agreement, and the remainder of the Agreement shall remain in full force and effect.

(f) No Trust or Fund Created . Neither the Plan nor the Agreement shall create or be construed to create a trust or separate fund of any kind or a fiduciary relationship between the Company or any Affiliate and Optionee or any other person.

(g) Headings . Headings are given to the Sections and subsections of the Agreement solely as a convenience to facilitate reference. Such headings shall not be deemed in any way material or relevant to the construction or interpretation of the Agreement or any provision thereof.

(h) Notices . Any notice required to be given or delivered to the Company under the terms of this Agreement shall be addressed to the Company at its principal corporate offices. Any notice required to be given or delivered to Optionee shall be addressed to Optionee at the address indicated below Optionee’s signature line at the end of this Agreement or at such other address as Optionee may designate by ten (10) days’ advance written notice to the Company. Any notice required to be given under this Agreement shall be in writing and shall be deemed effective upon personal delivery or upon the third (3rd) day following deposit in the U.S. mail, registered or certified, postage prepaid and properly addressed to the party entitled to such notice.

(i) Conditions Precedent to Issuance of Shares . Shares shall not be issued pursuant to the exercise of the Option unless such exercise and the issuance and delivery of the applicable Shares pursuant thereto shall comply with all relevant provisions of law, including, without limitation, the Securities Act of 1933, as amended, the Exchange Act of 1934, as amended, the rules and regulations promulgated thereunder, state blue sky laws, the requirements of any applicable stock exchange and the California General Corporation Law. As a condition to the exercise of the purchase price relating to the Option, the Company may require that the person exercising or paying the purchase price represent and warrant that the Shares are being purchased

 

5


only for investment and without any present intention to sell or distribute such Shares if, in the opinion of counsel for the Company, such a representation and warranty is required by law.

(j) Withholding . In order to provide the Company with the opportunity to claim the benefit of any income tax deduction which may be available to it upon the exercise of the Option and in order to comply with all applicable federal or state income tax laws or regulations, the Company may take such action as it deems appropriate to insure that, if necessary, all applicable federal or state payroll, withholding, income or other taxes are withheld or collected from Optionee.

(k) Consultation With Professional Tax and Investment Advisors . Optionee acknowledges that the grant, exercise and vesting with respect to this Option, and the sale or other taxable disposition of the Shares, may have tax consequences pursuant to the Code or under local, state or international tax laws. Optionee further acknowledges that Optionee is relying solely and exclusively on Optionee’s own professional tax and investment advisors with respect to any and all such matters (and is not relying, in any manner, on the Company or any of its employees or representatives). Optionee understands and agrees that any and all tax consequences resulting from the Option and its grant, exercise and vesting, and the sale or other taxable disposition of the Shares, is solely and exclusively the responsibility of Optionee without any expectation or understanding that the Company or any of its employees or representatives will pay or reimburse Optionee for such taxes or other items.

[SIGNATURE PAGE FOLLOWS]

 

6


IN WITNESS WHEREOF , the Company and Optionee have executed this Agreement on the date set forth in the first paragraph.

 

NOVABAY PHARMACEUTICALS, INC.
By:      
Name:       
Title:       
OPTIONEE:
By:      
Name:       
Address:       
   
Facsimile:       

 

7


NOVABAY PHARMACEUTICALS, INC.

STOCK UNIT AWARD AGREEMENT

This STOCK UNIT AWARD AGREEMENT (this “ Agreement ”), dated as of                          ,              (the “ Effective Date ”), is between NovaBay Pharmaceuticals, Inc., a California corporation (the “ Company ”), and                          , an individual resident of                          (“ Participant ”). This Stock Award is granted under the NovaBay Pharmaceuticals, Inc. 2007 Omnibus Incentive Plan (the “ Plan ”) and is subject to the terms of that Plan. This Agreement represents the Company’s unfunded and unsecured promise to issue common stock of the Company, $0.01 par value (“ Common Stock ”), at a future date, subject to the terms of this Agreement and the Plan.

1. Award . The Company hereby grants Participant, subject to the terms and conditions of this Agreement and the Plan, a stock award (the “ Stock Award ”) with respect to              shares (the “ Shares ”) of Common Stock. The Stock Award represents the right to receive the Shares only when, and with respect to the number of Shares to which, the Stock Award has vested (the “ Vested Shares ”). The Stock Award is subject to the terms and conditions set forth in this Agreement and in the Plan. A copy of the Plan will be furnished upon request of Participant.

2. Vesting . Subject to the terms and conditions of this Agreement and the Plan, the Stock Award shall vest and be converted into an equivalent number of shares that will be distributed to the Participant as follows:

 

On or after Each of the Following Dates    Percentage of Shares that Vest
  
  
  
  
  

3. Termination of Stock Award .

(a) Except as provided in subsections (b) below, a Participant’s rights under this Agreement with respect to the Stock Award shall terminate at the earlier of (i) the time such Stock Awards are converted into Vested Shares, or (ii) the termination of Participant’s employment with or Service to the Company. Upon termination of this Agreement in accordance with clause (ii) above, the Participant’s rights to all of the Shares subject to the Stock Award not vested on the date that Participant ceases to be an employee or to provide Service shall be immediately and irrevocably forfeited and the Participant will retain no rights with respect to the forfeited Shares.

(b) Notwithstanding the provisions of clause (ii) of Section 3(a) above, in the event of termination of Participant’s employment with or Service to the Company as a result of Participant’s death or Permanent Disability (as defined below) while in the employ or service of the Company, the next vesting date for the Stock Award, as set out


in Section 2 above, shall accelerate by twelve (12) months as of such date of termination. The Participant’s rights in any unvested shares subject to this Stock Award shall terminate at the time Participant ceases to be an employee or provide Service.

4. Additional Restrictions on Transfer of Stock Award . During the lifetime of Participant, this Stock Award cannot be sold, assigned, transferred, gifted, pledged, hypothecated or in any manner encumbered or disposed of at any time prior to delivery of the Vested Shares, other than by will or the laws of descent and distribution.

5. Conversion of Stock Award to Shares; Responsibility for Taxes .

(a) Provided Participant has satisfied the requirements of Section 5(b) below, after the vesting of the Stock Award with respect to Vested Shares, the Vested Shares will be distributed to Participant or, in the event of Participant’s death, to Participant’s legal representative, as soon as practicable. The distribution to the Participant, or in the case of the Participant’s death, to the Participant’s legal representative, of Vested Shares shall be evidenced by a stock certificate, appropriate entry on the books of the Company or of a duly authorized transfer agent of the Company, or other appropriate means as determined by the Company. No fractional share of stock shall be issued.

(b) By signing this Agreement, Participant agrees that the Company may withhold from the Vested Shares to be distributed to Participant in accordance with Section 5(a), and cancel and not issue such withheld Vested Shares in satisfaction of all income tax (including federal, state and local taxes), social insurance, payroll tax or other tax-related withholding (“ Tax Related Items ”), a number of Vested Shares as is equal to the quotient of (i) the Fair Market Value of the Shares on the date of vesting, (i) divided by the amount of Tax Related Items; provided that the Company shall withhold only the amount of Vested Shares necessary to satisfy the minimum withholding amount. To the extent that the Company determines that it is not feasible, or not permissible under applicable law, to withhold in Shares, then prior to the issuance of Vested Shares as provided in Section 5(a) above, Participant shall pay, or make adequate arrangements satisfactory to the Company or to the Participant’s actual employer (in their sole discretion) to satisfy all withholding obligations of the Company and/or the Participant’s actual employer. In this regard, Participant authorizes the Company or the Participant’s actual employer to withhold all applicable Tax Related Items legally payable by Participant from Participant’s wages or other cash compensation payable to Participant by the Company or the Participant’s actual employer. Participant shall pay to the Company or to the Participant’s actual employer any amount of Tax Related Items that the Company or the Participant’s actual employer may be required to withhold as a result of Participant’s receipt of the Stock Award, the vesting of the Stock Award, or the conversion of vested Stock Award to Shares that cannot be satisfied by the means previously described. The Company may refuse to deliver Vested Shares to Participant if Participant fails to comply with Participant’s obligation in connection with the Tax Related Items as described herein.

Regardless of any action the Company or the subsidiary of the Company that is Participant’s actual employer takes with respect to any or all Tax Related Items, Participant acknowledges that the ultimate liability for all Tax Related Items legally due by Participant is and remains Participant’s responsibility and that the Company and/or the Participant’s actual

 

2


employer (i) make no representations or undertakings regarding the treatment of any Tax Related Items in connection with any aspect of the Stock Award, including the grant of the Stock Award, the vesting of Stock Award with respect to Shares, the conversion of the Stock Award into Shares, the subsequent sale of any Shares acquired at vesting and the receipt of any dividends; and (ii) do not commit to structure the terms of the grant or any aspect of the Stock Award to reduce or eliminate the Participant’s liability for Tax Related Items.

6. Change in Control .

(a) If this Stock Award is assumed or otherwise continued in effect in connection with a Change in Control, then this Stock Award shall be appropriately adjusted, upon such Change in Control, to apply to the number and class of securities which would have been issuable to Participant in consummation of such Change in Control had this Stock Award been vested immediately prior to such Change in Control. To the extent that the holders of Common Stock receive cash consideration for their Common Stock in consummation of the Change in Control, the successor corporation (or its parent) may, in connection with the assumption of this Stock Award, substitute one or more shares of its own common stock with a fair market value equivalent to the cash consideration paid per share of Common Stock in such Change in Control.

(b) This Agreement shall not in any way affect the right of the Company to adjust, reclassify, reorganize or otherwise change its capital or business structure or to merge, consolidate, dissolve, liquidate or sell or transfer all or any part of its business or assets.

(c) For purposes of this Agreement, “ Change in Control ” shall mean a change in ownership or control of the Company effected through any of the following transactions: (i) a merger, consolidation or other reorganization unless securities representing more than 50% of the total combined voting power of the voting securities of the successor corporation are immediately thereafter beneficially owned, directly or indirectly and in substantially the same proportion, by the persons who beneficially owned the Company’s outstanding voting securities immediately prior to such transaction; (ii) the sale, transfer or other disposition of all or substantially all of the Company’s assets; or (iii) the acquisition, directly or indirectly by any person or related group of persons (other than the Company or a person that directly or indirectly controls, is controlled by, or is under common control with, the Company), of beneficial ownership (within the meaning of Rule 13d-3 of the Exchange Act) of securities possessing more than 50% of the total combined voting power of the Company’s outstanding securities pursuant to a tender or exchange offer made directly to the Company’s shareholders.

7. Capital Adjustments and Reorganization . Should any change be made to the Common Stock by reason of any stock split, reverse stock split, stock dividend, recapitalization, combination of shares, exchange of shares or other change affecting the outstanding Common Stock as a class without the Company’s receipt of consideration, appropriate adjustments shall be made to the number and/or class of securities subject to this Stock Award in order to reflect such change and thereby preclude a dilution or enlargement of benefits hereunder.

8. Miscellaneous .

(a) Entire Agreement; Plan Provisions Control . This Agreement (and any addendum hereto) and the Plan constitute the entire agreement between the parties hereto with regard to the subject matter hereof. In the event that any provision of the Agreement conflicts with or is inconsistent in any respect with the terms of the Plan, the terms of the Plan shall control. All

 

3


decisions of the Committee with respect to any question or issue arising under the Plan or this Agreement shall be and binding on all persons having an interest in this Stock Award. All capitalized terms used in this Agreement and not otherwise defined in this Agreement shall have the meaning assigned to them in the Plan.

(b) Rights of Shareholders . Prior to the vesting of the Stock Award, and prior to the receipt by the Participant, Participant’s legal representative, or a permissible assignee, of the Vested Shares as provided in this Agreement, neither Participant, Participant’s legal representative nor a permissible assignee of the Stock Award shall be or have any of the rights and privileges of a shareholder of the Company with respect to the Shares issuable to Participant pursuant to the terms of this Agreement. Participant shall not be entitled to receive dividend equivalents on the Stock Award.

(c) No Right to Employment . The grant of this Stock Award shall not be construed as giving Participant the right to be retained in the employ of, or if Participant is a director of the Company or an Affiliate as giving the Participant the right to continue as a director of, the Company or an Affiliate, nor will it affect in any way the right of the Company or an Affiliate to terminate such employment or position at any time, with or without cause. In addition, the Company or an Affiliate may at any time dismiss Participant from employment, or terminate the term of a director of the Company or an Affiliate, free from any liability or any claim under the Plan or this Agreement. Nothing in this Agreement shall confer on any person any legal or equitable right against the Company or any Affiliate, directly or indirectly, or give rise to any cause of action at law or in equity against the Company or an Affiliate. This Stock Award shall not form any part of the wages or salary of Participant for purposes of severance pay or termination indemnities, irrespective of the reason for termination of employment. Under no circumstances shall any person ceasing to be an employee of the Company or any Affiliate be entitled to any compensation for any loss of any right or benefit under this Agreement or the Plan which such employee might otherwise have enjoyed but for termination of employment, whether such compensation is claimed by way of damages for wrongful or unfair dismissal, breach of contract or otherwise. By participating in the Plan, Participant shall be deemed to have accepted all the terms and conditions of the Plan and this Agreement and the terms and conditions of any rules and regulations adopted by the Committee and shall be fully bound thereby.

(d) Governing Law . The validity, construction and effect of the Plan and this Agreement, and any rules and regulations relating to the Plan and this Agreement, shall be determined in accordance with the internal laws, and not the law of conflicts, of the State of California.

(e) Severability . If any provision of the Agreement is or becomes or is deemed to be invalid, illegal or unenforceable in any jurisdiction or would disqualify the Agreement under any law deemed applicable by the Committee, such provision shall be construed or deemed amended to conform to applicable laws, or if it cannot be so construed or deemed amended without, in the determination of the Committee, materially altering the purpose or intent of the Plan or the Agreement, such provision shall be stricken as to such jurisdiction or the Agreement, and the remainder of the Agreement shall remain in full force and effect.

(f) No Trust or Fund Created . Neither the Plan nor this Agreement shall create or be construed to create a trust or separate fund of any kind or a fiduciary relationship between the

 

4


Company or any Affiliate and Participant or any other person. To the extent that any Person acquires a right to receive payments from the Company or any Affiliate pursuant to a Stock Award, such right shall be no greater than the right of any unsecured creditor of the Company or any Affiliate.

(g) Headings . Headings are given to the Sections and subsections of this Agreement solely as a convenience to facilitate reference. Such headings shall not be deemed in any way material or relevant to the construction or interpretation of this Agreement or any provision thereof.

(h) Notices . Any notice required to be given or delivered to the Company under the terms of this Agreement shall be addressed to the Company at its principal corporate offices. Any notice required to be given or delivered to Participant shall be addressed to Participant at the address indicated below Participant’s signature line at the end of this Agreement or at such other address as Participant may designate by ten (10) days’ advance written notice to the Company. Any notice required to be given under this Agreement shall be in writing and shall be deemed effective upon personal delivery or upon the third (3rd) day following deposit in the U.S. mail, registered or certified, postage prepaid and properly addressed to the party entitled to such notice.

(i) Conditions Precedent to Issuance of Vested Shares . Vested Shares shall not be issued pursuant to the Stock Award unless such issuance and delivery of the applicable Vested Shares pursuant hereto shall comply with all relevant provisions of law, including, without limitation, the Securities Act of 1933, as amended, the Exchange Act of 1934, as amended, the rules and regulations promulgated thereunder, state blue sky laws, the requirements of any applicable stock exchange and the California General Corporation Law. As a condition to the issuance of the Vested Shares, the Company may require that the person receiving such Vested Shares represent and warrant that the Vested Shares are being acquired only for investment and without any present intention to sell or distribute such Vested Shares if, in the opinion of counsel for the Company, such a representation and warranty is required by law.

(j) Withholding . In order to provide the Company with the opportunity to claim the benefit of any income tax deduction which may be available to it in connection with the Stock Award, and in order to comply with all applicable federal or state tax laws or regulations, the Company may take such action as it deems appropriate to insure that, if necessary, all applicable federal or state payroll, withholding, income or other taxes are withheld or collected from Participant.

(k) Consultation With Professional Tax and Investment Advisors . Participant acknowledges that the grant and vesting with respect to this Stock Award, and the sale or other taxable disposition of the Vested Shares, may have tax consequences pursuant to the Internal Revenue Code of 1986, as amended, or under local, state or international tax laws. Participant further acknowledges that Participant is relying solely and exclusively on Participant’s own professional tax and investment advisors with respect to any and all such matters (and is not relying, in any manner, on the Company or any of its employees or representatives). Participant understands and agrees that any and all tax consequences resulting from the Stock Award and its grant and vesting, and the sale or other taxable disposition of the Vested Shares, is solely and

 

5


exclusively the responsibility of Participant without any expectation or understanding that the Company or any of its employees or representatives will pay or reimburse Participant for such taxes or other items.

[SIGNATURE PAGE FOLLOWS]

 

6


IN WITNESS WHEREOF , the Company and Participant have executed this Agreement on the date set forth in the first paragraph.

 

NOVABAY PHARMACEUTICALS, INC.
By:       
Name:       
Title:       
PARTICIPANT:
By:       
Name:       
Address:       
   
Facsimile:       

 

7


NOVABAY PHARMACEUTICALS, INC.

RESTRICTED STOCK AWARD AGREEMENT

This RESTRICTED STOCK AWARD AGREEMENT (the “ Agreement ”) is made this              day of              ,              , by and between NovaBay Pharmaceuticals, Inc., a California corporation (the “ Company ”), and              , an individual resident of              ,              (“ Participant ”).

1. Award . The Company hereby grants to Participant a restricted stock award of                      shares (the “ Shares ”) of common stock, par value $0.01 (“ Common Stock ”), of the Company according to the terms and conditions set forth herein and in the NovaBay Pharmaceuticals, Inc. 2007 Omnibus Incentive Plan (the “ Plan ”). The Shares are Restricted Stock granted under Section 6(c) of the Plan. A copy of the Plan will be furnished upon request of Participant. With respect to the Shares, Participant shall be entitled at all times on and after the date of issuance of the Shares to exercise the rights of a shareholder of Common Stock of the Company, including the right to vote the Shares and the right to receive dividends, if any, declared on the Shares.

2. Vesting . Except as otherwise provided in this Agreement, the Shares shall vest in accordance with the following schedule:

 

On each of the following dates    Number of Shares Vested
  
  
  
  
  
  

3. Restrictions on Transfer . Until the Shares vest pursuant to Sections 2 or 4 hereof, none of the Shares may be pledged, alienated, attached or otherwise encumbered, and any purported pledge, alienation, attachment or encumbrance shall be void and unenforceable against the Company, and no attempt to transfer the Shares, whether voluntary or involuntary, by operation of law or otherwise, shall vest the purported transferee with any interest or right in or with respect to the Shares.

4. Forfeiture; Early Vesting . If Participant ceases to be an employee of or provide Service to the Company or any Affiliate prior to vesting of the Shares pursuant to Sections 2 or 4 hereof, all of Participant’s rights to all of the unvested Shares shall be immediately and irrevocably forfeited, except that if Participant ceases to be an employee or provide Service by reason of death or Permanent Disability prior to the vesting of Shares under Sections 2 or 4 hereof, the next vesting date for the Shares, as set out in Section 2 above, shall accelerate by twelve (12) months as of such date of termination. Upon forfeiture, Participant will no longer


have any rights relating to the unvested Shares, including the right to vote the Shares and the right to receive dividends, if any, declared on the Shares.

5. Distributions and Adjustments .

(a) If any Shares vest subsequent to any change in the number or character of the Common Stock of the Company (through any stock dividend or other distribution, recapitalization, stock split, reverse stock split, reorganization, merger, consolidation, split-up, spin-off, combination, repurchase or exchange of shares, or otherwise), Participant shall receive upon such vesting the number and type of securities or other consideration which Participant would have received if such Shares had vested prior to the event changing the number or character of the outstanding Common Stock.

(b) Any additional shares of Common Stock of the Company, any other securities of the Company and any other property (except for regular cash dividends or other cash distributions) distributed with respect to the Shares prior to the date or dates the Shares vest shall be subject to the same restrictions, terms and conditions as the Shares to which they relate and shall be promptly deposited with the Secretary of the Company or a custodian designated by the Secretary.

6. Change in Control .

(a) If this Agreement is assumed or otherwise continued in effect in connection with a Change in Control, then this Agreement shall be appropriately adjusted, upon such Change in Control, to apply to the number and class of securities which would have been issuable to Participant in consummation of such Change in Control had the Shares been vested immediately prior to such Change in Control. To the extent that the holders of Common Stock receive cash consideration for their Common Stock in consummation of the Change in Control, the successor corporation (or its parent) may, in connection with the assumption of this Agreement, substitute one or more shares of its own common stock with a fair market value equivalent to the cash consideration paid per share of Common Stock in such Change in Control.

(b) This Agreement shall not in any way affect the right of the Company to adjust, reclassify, reorganize or otherwise change its capital or business structure or to merge, consolidate, dissolve, liquidate or sell or transfer all or any part of its business or assets.

(c) For purposes of this Agreement, “ Change in Control ” shall mean a change in ownership or control of the Company effected through any of the following transactions: (i) a merger, consolidation or other reorganization unless securities representing more than 50% of the total combined voting power of the voting securities of the successor corporation are immediately thereafter beneficially owned, directly or indirectly and in substantially the same proportion, by the persons who beneficially owned the Company’s outstanding voting securities immediately prior to such transaction; (ii) the sale, transfer or other disposition of all or substantially all of the Company’s assets; or (iii) the acquisition, directly or indirectly by any person or related group of persons (other than the Company or a person that directly or indirectly controls, is controlled by, or is under common control with, the Company), of beneficial ownership (within the meaning of Rule 13d-3 of the Exchange Act) of securities possessing more

 

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than 50% of the total combined voting power of the Company’s outstanding securities pursuant to a tender or exchange offer made directly to the Company’s shareholders.

7. Miscellaneous .

(a) Issuance of Shares . The Company shall cause the Shares to be issued in the name of Participant, either by book-entry registration or issuance of a stock certificate or certificates evidencing the Shares, which certificate or certificates shall be held by the Secretary of the Company or the stock transfer agent or brokerage service selected by the Secretary of the Company to provide such services for the Plan. The Shares shall be restricted from transfer and shall be subject to an appropriate stop-transfer order. If any certificate is used, the certificate shall bear an appropriate legend referring to the restrictions applicable to the Shares. Participant hereby agrees to the retention by the Company of the Shares and, if a stock certificate is used, agrees to execute and deliver to the Company a blank stock power with respect to the Shares as a condition to the receipt of this award of Shares. After any Shares vest pursuant to Sections 2 or 4 hereof, and following payment of the applicable withholding taxes pursuant to Section 7(b) of this Agreement, the Company shall promptly cause to be issued a certificate or certificates, registered in the name of Participant or in the name of Participant’s legal representatives, beneficiaries or heirs, as the case may be, evidencing such vested whole Shares (less any shares withheld to pay withholding taxes) and shall cause such certificate or certificates to be delivered to Participant or Participant’s legal representatives, beneficiaries or heirs, as the case may be, free of the legend or the stop-transfer order referenced above. No fractional share of stock shall be issued.

(b) Income Tax Matters .

(i) In order to comply with all applicable federal or state income tax laws or regulations, the Company may take such action as it deems appropriate to ensure that all applicable federal or state payroll, withholding, income or other taxes, which are the sole and absolute responsibility of Participant, are withheld or collected from Participant.

(ii) In accordance with the terms of the Plan, and such rules as may be adopted by the Committee under the Plan, Participant may elect to satisfy Participant’s federal and state income tax withholding obligations arising from the receipt of, or the lapse of restrictions relating to, the Shares, by (i) delivering cash, check (bank check, certified check or personal check) or money order payable to the Company, (ii) having the Company withhold a portion of the Shares otherwise to be delivered having a Fair Market Value equal to the amount of such taxes, or (iii) delivering to the Company shares of Common Stock already owned by Participant having a Fair Market Value equal to the amount of such taxes. Any shares already owned by Participant for no less than six months prior to the date delivered to the Company if such shares were acquired upon the exercise of an option or upon the vesting of restricted stock units or other restricted stock. The Company will not deliver any fractional Shares but will pay, in lieu thereof, the Fair Market Value of such fractional Shares. Participant’s election must be made on or before the date that the amount of tax to be withheld is determined.

(c) Entire Agreement; Plan Provisions Control . This Agreement (and any addendum hereto) and the Plan constitute the entire agreement between the parties hereto with regard to the subject matter hereof. In the event that any provision of the Agreement conflicts with or is

 

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inconsistent in any respect with the terms of the Plan, the terms of the Plan shall control. All decisions of the Committee with respect to any question or issue arising under the Plan or this Agreement shall be and binding on all persons having an interest in the Shares. All capitalized terms used in this Agreement and not otherwise defined in this Agreement shall have the meaning assigned to them in the Plan.

(d) No Right to Employment . The issuance of the Shares shall not be construed as giving Participant the right to be retained in the employ of, or if Participant is a director of the Company or an Affiliate as giving the Participant the right to continue as a director of, the Company or an Affiliate, nor will it affect in any way the right of the Company or an Affiliate to terminate such employment or position at any time, with or without cause. In addition, the Company or an Affiliate may at any time dismiss Participant from employment, or terminate the term of a director of the Company or an Affiliate, free from any liability or any claim under the Plan or the Agreement. Nothing in the Agreement shall confer on any person any legal or equitable right against the Company or any Affiliate, directly or indirectly, or give rise to any cause of action at law or in equity against the Company or an Affiliate. The Shares shall not form any part of the wages or salary of Participant for purposes of severance pay or termination indemnities, irrespective of the reason for termination of employment. Under no circumstances shall any person ceasing to be an employee of the Company or any Affiliate be entitled to any compensation for any loss of any right or benefit under the Agreement or Plan which such employee might otherwise have enjoyed but for termination of employment, whether such compensation is claimed by way of damages for wrongful or unfair dismissal, breach of contract or otherwise. By participating in the Plan, Participant shall be deemed to have accepted all the conditions of the Plan and the Agreement and the terms and conditions of any rules and regulations adopted by the Committee and shall be fully bound thereby.

(e) Governing Law . The validity, construction and effect of the Plan and the Agreement, and any rules and regulations relating to the Plan and the Agreement, shall be determined in accordance with the internal laws, and not the law of conflicts, of the State of California.

(f) Severability . If any provision of the Agreement is or becomes or is deemed to be invalid, illegal or unenforceable in any jurisdiction or would disqualify the Agreement under any law deemed applicable by the Committee, such provision shall be construed or deemed amended to conform to applicable laws, or if it cannot be so construed or deemed amended without, in the determination of the Committee, materially altering the purpose or intent of the Plan or the Agreement, such provision shall be stricken as to such jurisdiction or the Agreement, and the remainder of the Agreement shall remain in full force and effect.

(g) No Trust or Fund Created . Neither the Plan nor the Agreement shall create or be construed to create a trust or separate fund of any kind or a fiduciary relationship between the Company or any Affiliate and Participant or any other person.

(h) Headings . Headings are given to the Sections and subsections of the Agreement solely as a convenience to facilitate reference. Such headings shall not be deemed in any way material or relevant to the construction or interpretation of the Agreement or any provision thereof.

 

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(i) Notices . Any notice required to be given or delivered to the Company under the terms of this Agreement shall be addressed to the Company at its principal corporate offices. Any notice required to be given or delivered to Participant shall be addressed to Participant at the address indicated below Participant’s signature line at the end of this Agreement or at such other address as Participant may designate by ten (10) days’ advance written notice to the Company. Any notice required to be given under this Agreement shall be in writing and shall be deemed effective upon personal delivery or upon the third (3rd) day following deposit in the U.S. mail, registered or certified, postage prepaid and properly addressed to the party entitled to such notice.

(j) Conditions Precedent to Issuance of Shares . Shares shall not be issued pursuant to this Agreement unless such issuance and delivery of the Shares pursuant hereto shall comply with all relevant provisions of law, including, without limitation, the Securities Act of 1933, as amended, the Exchange Act of 1934, as amended, the rules and regulations promulgated thereunder, state blue sky laws, the requirements of any applicable stock exchange and the California General Corporation Law. As a condition to the issuance of the Shares, the Company may require that the person receiving such Shares represent and warrant that the Shares are being acquired only for investment and without any present intention to sell or distribute such Shares if, in the opinion of counsel for the Company, such a representation and warranty is required by law.

(k) Consultation With Professional Tax and Investment Advisors . Participant acknowledges that the grant and vesting with respect to the Shares, and the sale or other taxable disposition of the vested Shares, may have tax consequences pursuant to the Internal Revenue Code of 1986, as amended, or under local, state or international tax laws. Participant further acknowledges that Participant is relying solely and exclusively on Participant’s own professional tax and investment advisors with respect to any and all such matters (and is not relying, in any manner, on the Company or any of its employees or representatives). Participant understands and agrees that any and all tax consequences resulting from the grant and vesting of the Shares, and the sale or other taxable disposition of the vested Shares, is solely and exclusively the responsibility of Participant without any expectation or understanding that the Company or any of its employees or representatives will pay or reimburse Participant for such taxes or other items.

[SIGNATURE PAGE FOLLOWS]

 

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IN WITNESS WHEREOF , the Company and Participant have executed this Restricted Stock Award Agreement on the date set forth in the first paragraph.

NOVABAY PHARMACEUTICALS, INC.
By:      
Name:      
Title:      
PARTICIPANT:
By:      
Name:      
Address:      
   
Facsimile:      


NOVABAY PHARMACEUTICALS, INC.

STOCK APPRECIATION RIGHTS AGREEMENT

(STOCK SETTLED)

This STOCK APPRECIATION RIGHTS AGREEMENT (this “ Agreement ”), dated as of                      ,              (the “ Effective Date ”), is between NovaBay Pharmaceuticals, Inc., a California corporation (the “ Company ”), and              , an individual resident of                      (“ Participant ”). This Agreement is granted under the NovaBay Pharmaceuticals, Inc. 2007 Omnibus Incentive Plan (the “ Plan ”) and is subject to the terms of that Plan. This Agreement represents the Company’s unfunded and unsecured promise to issue common stock of the Company, $0.01 par value (“ Shares ”) at a future date based on appreciation in the market value of such Shares from the date of this Agreement, subject to the terms of this Agreement and the Plan.

1. Award . The Company hereby grants Participant stock appreciation rights (the “ SAR ”) with respect to              shares of Common Stock (the “ Award ”). The initial value of the SAR is $              per share (the “ Grant Price ”). The Award represents the right to receive the Shares only when, and with respect to the number of Shares to which, the Award has vested (the “ Vested Shares ”). The Award is subject to the terms and conditions set forth in this Agreement and in the Plan. A copy of the Plan will be furnished upon request of Participant. The SAR shall terminate at the close of business ten (10) years from the Effective Date.

2. Vesting . Subject to the terms and conditions of this Agreement and the Plan, the SAR awarded to Participant pursuant to this Agreement shall vest and may be exercised by Participant with respect to the number of Vested Shares set forth in the following schedule:

 

On or after Each of the Following Dates   

Percentage of Shares with

Respect to Which the SAR Is Exercisable

  
  
  
  
  

3. Exercise of SAR after Death or Termination of Employment or Service . The SAR shall terminate and may no longer be exercised if Participant ceases to be employed by or provide Service to the Company or its Affiliates, except that:

(a) If Participant’s employment or Service shall be terminated for any reason, voluntary or involuntary, other than for “ Misconduct ” (as defined in Section 3(e)) or Participant’s death or Permanent Disability, Participant may at any time within a period of three (3) months after such termination exercise the SAR to the extent the SAR was exercisable by Participant on the date of the termination of Participant’s employment or Service.


(b) If Participant’s employment is terminated for Misconduct, the SAR shall be terminated as of the date of the act giving rise to such termination.

(c) If Participant shall die while the SAR is still exercisable according to its terms, or if employment or Service is terminated because of Participant’s Permanent Disability while in the employ or Service of the Company and Participant shall not have fully exercised the SAR, such SAR may be exercised at any time within twelve (12) months after Participant’s death or date of termination of employment or Service for such Permanent Disability by Participant, personal representatives, administrators or guardians of Participant, as applicable, or by any person or persons to whom the SAR is transferred by will or the applicable laws of descent and distribution, to the extent of the full number of Vested Shares Participant was entitled to purchase under the SAR on (i) the earlier of the date of death or termination of employment or Service or (ii) the date of termination for such Permanent Disability, as applicable.

(d) Notwithstanding the above, in no case may the SAR be exercised to any extent by anyone after the termination date of the SAR.

(e) “ Misconduct ” shall mean (i) the commission of any act of fraud, embezzlement or dishonesty by Participant, (ii) any unauthorized use or disclosure by such person of confidential information or trade secrets of the Company (or of any Affiliate), or (iii) any other intentional misconduct by such person adversely affecting the business or affairs of the Company (or any Affiliate) in a material manner. However, if the term or concept has been defined in an employment agreement between the Company and Participant, then Misconduct shall have the definition set forth in such employment agreement. The foregoing definition shall not in any way preclude or restrict the right of the Company (or any Affiliate) to discharge or dismiss any Participant or other person in the Service of the Company (or any Affiliate) for any other acts or omissions but such other acts or omissions shall not be deemed, for purposes of the Agreement, to constitute grounds for termination for Misconduct.

4. Method of Exercise of SAR .

(a) SARs may be exercised with respect to Vested Shares by delivery to the Company of a written notice which shall state that Participant elects to exercise the SAR as to the number of Vested Shares specified in the notice as of the date specified in the notice.

(b) Subject to deduction as described in Section 4(c) for withholding, upon exercise of the SAR, the Participant shall be entitled to receive a number of Shares (“ Issued Shares ”) for each Vested Share with respect to which the SAR is exercised that is equal to (i) the excess of the Fair Market Value of one Share on the date of exercise, over the Grant Price, divided by (ii) the Fair Market Value of one Share on the date of exercise. The distribution to the Participant, or in the case of the Participant’s death, to the Participant’s legal representative, of Issued Shares shall be evidenced by a stock certificate, appropriate entry on the books of the Company or of a duly authorized transfer agent of the Company, or other appropriate means as determined by the Company. This SAR may be exercised only with respect to full shares and no fractional share of stock shall be issued.

 

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(c) By signing this Agreement, Participant agrees that the Company may withhold from Issued Shares due upon exercise of the SAR, or at its election from the Participant’s wages or other cash compensation, all income tax (including federal, state and local taxes), social insurance, payroll tax or other tax-related withholding (“ Tax Related Items ”) due from the Company or the subsidiary that is the Participant’s actual employer. To the extent that the Company determines that it is not feasible, or not permissible under applicable law, to withhold in Shares, then prior to the issuance of Issued Shares as provided in Section 4(b) above, Participant shall pay, or make adequate arrangements satisfactory to the Company or to the Participant’s actual employer (in their sole discretion) to satisfy all withholding obligations of the Company and/or the Participant’s actual employer. In this regard, Participant authorizes the Company or the Participant’s actual employer to withhold all applicable Tax Related Items legally payable by Participant from Participant’s wages or other cash compensation payable to Participant by the Company or the Participant’s actual employer. Participant shall pay to the Company or to the Participant’s actual employer any amount of Tax Related Items that the Company or the Participant’s actual employer may be required to withhold as a result of Participant’s receipt of the Award, the vesting of the Award, or exercise of the Award that cannot be satisfied by the means previously described. The Company may refuse to deliver Issued Shares to Participant if Participant fails to comply with Participant’s obligation in connection with the Tax Related Items as described herein.

Regardless of any action the Company or the subsidiary of the Company that is Participant’s actual employer takes with respect to any or all Tax Related Items, Participant acknowledges that the ultimate liability for all Tax Related Items legally due by Participant is and remains Participant’s responsibility and that the Company and/or the Participant’s actual employer (i) make no representations or undertakings regarding the treatment of any Tax Related Items in connection with any aspect of the Award, including the grant of the Award, the vesting of Award, or the exercise of the Award; and (ii) do not commit to structure the terms of the grant or any aspect of the Award to reduce or eliminate the Participant’s liability for Tax Related Items.

5. Additional Restrictions on Transfer of SAR . During the lifetime of Participant, the SAR shall be exercisable only by Participant and shall not be sold, assigned, transferred, gifted, pledged, hypothecated, or in any manner encumbered or disposed of at any time prior to delivery of the Issued Shares in accordance with Section 4, other than by will or the laws of descent and distribution.

6. Change in Control .

(a) If this SAR is assumed or otherwise continued in effect in connection with a Change in Control, then this SAR shall be appropriately adjusted, upon such Change in Control, to apply to the number and class of securities which would have been issuable to Participant in consummation of such Change in Control had this SAR been exercised immediately prior to such Change in Control, and appropriate adjustments shall also be made to the Grant Price, provided the aggregate Grant Price shall remain the same. To the extent that the holders of Common Stock receive cash consideration for their Common Stock in consummation of the Change in Control, the successor corporation (or its parent) may, in connection with the assumption of this

 

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SAR, substitute one or more shares of its own common stock with a fair market value equivalent to the cash consideration paid per share of Common Stock in such Change in Control.

(b) This Agreement shall not in any way affect the right of the Company to adjust, reclassify, reorganize or otherwise change its capital or business structure or to merge, consolidate, dissolve, liquidate or sell or transfer all or any part of its business or assets.

(c) For purposes of this Agreement, “ Change in Control ” shall mean a change in ownership or control of the Company effected through any of the following transactions: (i) a merger, consolidation or other reorganization unless securities representing more than 50% of the total combined voting power of the voting securities of the successor corporation are immediately thereafter beneficially owned, directly or indirectly and in substantially the same proportion, by the persons who beneficially owned the Company’s outstanding voting securities immediately prior to such transaction; (ii) the sale, transfer or other disposition of all or substantially all of the Company’s assets; or (iii) the acquisition, directly or indirectly by any person or related group of persons (other than the Company or a person that directly or indirectly controls, is controlled by, or is under common control with, the Company), of beneficial ownership (within the meaning of Rule 13d-3 of the Exchange Act) of securities possessing more than 50% of the total combined voting power of the Company’s outstanding securities pursuant to a tender or exchange offer made directly to the Company’s shareholders.

7. Capital Adjustments and Reorganization . Should any change be made to the Common Stock by reason of any stock split, reverse stock split, stock dividend, recapitalization, combination of shares, exchange of shares or other change affecting the outstanding Common Stock as a class without the Company’s receipt of consideration, appropriate adjustments shall be made to (a) the number and/or class of securities subject to this SAR and (b) the Grant Price in order to reflect such change and thereby preclude a dilution or enlargement of benefits hereunder.

8. Miscellaneous .

(a) Entire Agreement; Plan Provisions Control . This Agreement (and any addendum hereto) and the Plan constitute the entire agreement between the parties hereto with regard to the subject matter hereof. In the event that any provision of the Agreement conflicts with or is inconsistent in any respect with the terms of the Plan, the terms of the Plan shall control. All decisions of the Committee with respect to any question or issue arising under the Plan or this Agreement shall be and binding on all persons having an interest in this SAR. All capitalized terms used in this Agreement and not otherwise defined in this Agreement shall have the meaning assigned to them in the Plan.

(b) Rights of Shareholders . Prior to the exercise of the SAR and prior to receipt by the Participant, Participant’s legal representative, or a permissible assignee, of Issued Shares as provided in this Agreement, neither Participant, Participant’s legal representative nor a permissible assignee shall be or have any of the rights and privileges of a shareholder of the Company with respect to this Agreement or the Shares subject to the Award referenced in this Agreement.

 

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(c) No Right to Employment . The grant of the SAR shall not be construed as giving Participant the right to be retained in the employ of, or if Participant is a director of the Company or an Affiliate as giving the Participant the right to continue as a director of, the Company or an Affiliate, nor will it affect in any way the right of the Company or an Affiliate to terminate such employment or position at any time, with or without cause. In addition, the Company or an Affiliate may at any time dismiss Participant from employment, or terminate the term of a director of the Company or an Affiliate, free from any liability or any claim under the Plan or this Agreement. Nothing in this Agreement shall confer on any person any legal or equitable right against the Company or any Affiliate, directly or indirectly, or give rise to any cause of action at law or in equity against the Company or an Affiliate. The SAR granted under this Agreement shall not form any part of the wages or salary of Participant for purposes of severance pay or termination indemnities, irrespective of the reason for termination of employment. Under no circumstances shall any person ceasing to be an employee of the Company or any Affiliate be entitled to any compensation for any loss of any right or benefit under this Agreement or the Plan which such employee might otherwise have enjoyed but for termination of employment, whether such compensation is claimed by way of damages for wrongful or unfair dismissal, breach of contract or otherwise. By participating in the Plan, Participant shall be deemed to have accepted all the terms and conditions of the Plan and this Agreement and the terms and conditions of any rules and regulations adopted by the Committee and shall be fully bound thereby.

(d) Governing Law . The validity, construction and effect of the Plan and this Agreement, and any rules and regulations relating to the Plan and this Agreement, shall be determined in accordance with the internal laws, and not the law of conflicts, of the State of California.

(e) Severability . If any provision of the Agreement is or becomes or is deemed to be invalid, illegal or unenforceable in any jurisdiction or would disqualify the Agreement under any law deemed applicable by the Committee, such provision shall be construed or deemed amended to conform to applicable laws, or if it cannot be so construed or deemed amended without, in the determination of the Committee, materially altering the purpose or intent of the Plan or the Agreement, such provision shall be stricken as to such jurisdiction or the Agreement, and the remainder of the Agreement shall remain in full force and effect.

(f) No Trust or Fund Created . Neither the Plan nor this Agreement shall create or be construed to create a trust or separate fund of any kind or a fiduciary relationship between the Company or any Affiliate and Participant or any other person. To the extent that any Person acquires a right to receive payments from the Company or any Affiliate pursuant to an Award, such right shall be no greater than the right of any unsecured creditor of the Company or any Affiliate.

(g) Headings . Headings are given to the Sections and subsections of the Agreement solely as a convenience to facilitate reference. Such headings shall not be deemed in any way material or relevant to the construction or interpretation of the Agreement or any provision thereof.

(h) Notices . Any notice required to be given or delivered to the Company under the terms of this Agreement shall be addressed to the Company at its principal corporate offices.

 

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Any notice required to be given or delivered to Participant shall be addressed to Participant at the address indicated below Participant’s signature line at the end of this Agreement or at such other address as Participant may designate by ten (10) days’ advance written notice to the Company. Any notice required to be given under this Agreement shall be in writing and shall be deemed effective upon personal delivery or upon the third (3rd) day following deposit in the U.S. mail, registered or certified, postage prepaid and properly addressed to the party entitled to such notice.

(i) Conditions Precedent to Issuance of Issued Shares . Issued Shares shall not be issued pursuant to the exercise of the SAR unless such exercise and the issuance and delivery of the applicable Issued Shares pursuant thereto shall comply with all relevant provisions of law, including, without limitation, the Securities Act of 1933, as amended, the Exchange Act of 1934, as amended, the rules and regulations promulgated thereunder, state blue sky laws, the requirements of any applicable stock exchange and the California General Corporation Law. As a condition to the exercise of the purchase price relating to the SAR, the Company may require that the person exercising or paying the purchase price represent and warrant that the Issued Shares are being purchased only for investment and without any present intention to sell or distribute such Issued Shares if, in the opinion of counsel for the Company, such a representation and warranty is required by law.

(j) Withholding . In order to provide the Company with the opportunity to claim the benefit of any income tax deduction which may be available to it in connection with the Award, and in order to comply with all applicable federal or state tax laws or regulations, the Company may take such action as it deems appropriate to insure that, if necessary, all applicable federal or state payroll, withholding, income or other taxes are withheld or collected from Participant.

(k) Consultation With Professional Tax and Investment Advisors . Participant acknowledges that the grant, exercise and vesting with respect to this SAR, and the sale or other taxable disposition of the Issued Shares, may have tax consequences pursuant to the Internal Revenue Code of 1986, as amended, or under local, state or international tax laws. Participant further acknowledges that Participant is relying solely and exclusively on Participant’s own professional tax and investment advisors with respect to any and all such matters (and is not relying, in any manner, on the Company or any of its employees or representatives). Participant understands and agrees that any and all tax consequences resulting from the SAR and its grant, exercise and vesting, and the sale or other taxable disposition of the Issued Shares, is solely and exclusively the responsibility of Participant without any expectation or understanding that the Company or any of its employees or representatives will pay or reimburse Participant for such taxes or other items.

[SIGNATURE PAGE FOLLOWS]

 

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IN WITNESS WHEREOF , the Company and Participant have executed this Agreement on the date set forth in the first paragraph.

NOVABAY PHARMACEUTICALS, INC.
By:      
Name:      
Title:      
PARTICIPANT:
By:      
Name:      
Address:      
   
Facsimile:      

 

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Exhibit 10.11

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR CERTAIN REDACTED PROVISIONS OF THIS AGREEMENT. THE REDACTED PROVISIONS ARE IDENTIFIED BY THREE ASTERISKS AND ENCLOSED BY BRACKETS. THE CONFIDENTIAL PORTION HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.


CONFIDENTIAL

COLLABORATION AND LICENSE AGREEMENT

This COLLABORATION AND LICENSE AGREEMENT (this “ Agreement ”) is entered into as of the 29 th day of August, 2006 (the “ Effective Date ”) by and between NovaCal Pharmaceuticals, Inc., a California corporation, having its principal place of business at 5980 Horton Street, Suite 550, Emeryville, California 94608 (“ NovaCal ”) and Alcon Manufacturing, Ltd., a Texas partnership, having its principal place of business at 6201 S. Freeway, Fort Worth, Texas 76134-2099 (“ Alcon ”). NovaCal and Alcon are each referred to herein by name or, individually, as a “ Party ” or, collectively, as “ Parties .”

BACKGROUND

A. NovaCal has developed certain proprietary technologies related to Aganocide Compounds, including those certain drug candidates referred to as NVC-101 and NVC-422.

B. Alcon is a leader in the discovery, development, and commercialization of pharmaceutical products.

C. NovaCal and Alcon wish to collaborate to develop and obtain regulatory approval for, and commercialize, on a global basis pharmaceutical products incorporating NVC-422 and/or other Licensed Compounds (as defined below) resulting from the collaboration for applications in the Field, with Alcon having primary responsibility for marketing and selling such products throughout the world, all on the terms and conditions set forth herein below.

NOW, THEREFORE, in consideration of the mutual covenants and agreements provided herein below and other consideration to the receipt and sufficiency of which is hereby acknowledged, NovaCal and Alcon hereby agree as follows:

ARTICLE 1

DEFINITIONS

The following capitalized terms shall have the meanings given in this Article 1 when used in this Agreement:

1.1 “ Adverse Drug Reaction ” shall have the meaning as defined in the then-current guidelines and regulations promulgated by the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) and shall include any “Adverse Drug Experience” as defined in the then-current 21 CFR Sections 312.32 and 314.80.

1.2 “ Affiliate ” shall mean, with respect to a subject entity, another entity that controls, is controlled by or is under common control with such subject entity, for so long as such control exists. For purposes of this definition only, “control” shall mean beneficial ownership (direct or indirect) of at least fifty percent (50%) of the shares of the subject entity entitled to vote in the election of directors (or, in the case of an entity that is not a corporation, in the election of the corresponding managing authority).


1.3 “ Aganocide Compound ” shall mean any chemical entity (i) having bactericidal, antibacterial, anti-infective, antimicrobial, antifungal, anti-parasitic, sporicidal, antiviral, immunomodulatory or anti-inflammatory activity, and (ii) consisting of either hypochlorous acid or consisting of the following chemical formula:[***]. For clarity, Aganocide Compounds shall include the compounds described in Exhibit 1.3.

1.4 “ Agreement Wind-Down Period ” shall have the meaning assigned in Section 12.5.1(b).

1.5 “ Alcon Indemnities ” shall have the meaning assigned in Section 11.4.1.

1.6 “ Asia ” shall have the meaning assigned in Section 5.4.1(a).

1.7 “ Collaboration ” shall mean all activities performed by or on behalf of each Party under this Agreement, including all activities of each Party under any Plan. For clarity, during the Exclusivity Period all activities performed by or on behalf of either Party directed toward the Field shall be deemed in respect of the Collaboration.

1.8 “ Co-Marketing Partner ” shall have the meaning assigned in Section 5.4.1(a).

1.9 “ Commercialization ” shall mean, with respect to a particular Licensed Product in the Field, any and all processes and activities conducted to establish and maintain sales for such Licensed Product (including with respect to reimbursement and patient access), including offering for sale, selling (including launch), marketing (including education and advertising activities), promoting, storing, transporting, distributing, and importing such Licensed Product. For clarity, Commercialization shall exclude all Discovery, Development and Manufacturing processes and activities. “ Commercialize ” and “ Commercializing ” shall have their correlative meanings.

1.10 “ Commercialization Plan ” shall have the meaning assigned in Section 5.2.

1.11 “ Commercially Reasonable Efforts ” shall mean, with respect to a Party, a commitment by or on behalf of such Party of sustained, continued and active efforts and level of resources and urgency applied by such Party to a certain activity or activities that is consistent with such Party’s practices for its other pharmaceutical products of a similar stage of product life, safety, efficacy and commercial potential, but in no event less than the high professional standards and level of efforts, resources and urgency applied by other pharmaceutical companies of similar size to their high-priority development candidates and pharmaceutical products of a similar stage of product life, safety, efficacy and commercial potential. Without limiting the foregoing, Commercially Reasonable

 

[***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission.

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Efforts shall require the applicable Party to: (i) promptly assign responsibilities for activities for which it responsible to specific employee(s) that are held accountable for the progress, monitoring and completion of such activities, (ii) set and consistently seek to achieve meaningful objectives for carrying out such activities, and (iii) consistently make and implement decisions and allocate the full complement of resources necessary or appropriate to advance progress with respect to and complete such objectives in an expeditious manner.

1.12 “ Common Compound ” shall mean a Development Compound that NovaCal (itself or through one or more Third Parties) is developing (including preclinical development) or commercializing for applications outside of the Field. As used in this Section 1.12, the term “developing” shall have the meaning indicated for the term “Development” in Section 1.22.

1.13 “ Competing Product ” shall have the meaning assigned in Section 8.4.7.

1.14 “ Competing Program ” shall have the meaning assigned in Section 7.4.3.

1.15 “ Compound Improvement ” shall have the meaning assigned in Section 9.1.2.

1.16 “ Confidential Information ” shall have the meaning assigned in Section 10.1.

1.17 “ Control ” shall mean, with respect to particular Know-How or a particular Patent, possession by the Party granting the applicable right, license or sublicense to the other Party as provided herein of the power and authority, whether arising by ownership, license, or other authorization, to disclose and deliver the particular Know-How to the other Party, and to grant and authorize under such Know-How or Patent the right, license or sublicense, as applicable, of the scope granted to such other Party in this Agreement without giving rise to a violation of the terms of any written agreement with any Third Party.

1.18 “ Cooperating Party ” shall have the meaning assigned in Section 10.4.2.

1.19 “ Coordination Committee ” shall have the meaning assigned in Section 2.1.1.

1.20 “ Cover, Covered or Covering ” shall have the meaning assigned in Section 8.4.4(b).

1.21 “ Data ” shall mean any and all research and development data, such as preclinical data, pharmacology data, chemistry data (including analytical, product characterization, manufacturing, and stability data), toxicology data, clinical data (including investigator reports (both preliminary and final), statistical analyses, expert opinions and reports, safety and other electronic databases), together with supporting data, in each case specifically directed to, or used in the Development of, a Licensed Product and Controlled by a Party during the Term.

1.22 “ Development ” shall mean, with respect to any Licensed Product in the Field, any and all processes and activities conducted to file for, obtain and maintain Marketing Approvals for such Licensed Product after the designation of the Development Compound incorporated therein in accordance with Section 3.4, which may involve preclinical testing, ADME (absorption, distribution,

 

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metabolism and excretion) and toxicology studies, clinical trials (including trials for additional indications in the Field for a Licensed Product for which a Marketing Approval has been obtained), quality of life assessments, pharmacoeconomics, post-marketing studies, label expansion studies, regulatory affairs, and further activities related to development of such Licensed Product. For clarity, Development shall exclude all Discovery, Manufacturing and Commercialization processes and activities. “ Develop ” and “ Developing ” shall have their correlative meanings.

1.23 “ Development Compound ” shall mean any Licensed Compound that is designated as a Development Compound by the Coordination Committee in accordance with Section 3.4.

1.24 “ Development Plan ” shall have the meaning assigned in Section 4.2.1.

1.25 “ Development Program ” shall have the meaning assigned in Section 4.1.2.

1.26 “ Discovery ” shall mean, with respect to an Aganocide Compound, any and all processes and activities conducted to discover, generate, identify, and optimize such Aganocide Compound to meet criteria established therefor by the Coordination Committee from time to time or otherwise taken with respect to such Aganocide Compound prior to its designation as a Development Compound pursuant to Section 3.4. For clarity, Discovery shall exclude all Development, Manufacturing and Commercialization processes and activities. “ Discover ” and “ Discovering ” shall have their correlative meanings.

1.27 “ Discovery Research Plan ” shall have the meaning assigned in Section 3.2.

1.28 “ Discovery Research Program ” shall have the meaning assigned in Section 3.1.

1.29 “ Enabling Party ” shall have the meaning assigned in Section 6.2.3.

1.30 “ Enforcement Action ” shall have the meaning assigned in Section 9.4.

1.31 “ Exclusivity Period ” shall mean the period commencing on the Effective Date and expiring on the fifth (5 th ) anniversary following the end of the Funding Term.

1.32 “ FDA ” shall mean the United States Food and Drug Administration or any successor entity.

1.33 “ Field ” shall mean, collectively, the Ophthalmic Sub-Field, Otic Sub-Field and Sinus Sub-Field, in each case subject to Sections 7.2 and 12.5.2. The Ophthalmic Sub-Field, Otic Sub-Field and Sinus Sub-Field may each be referred to herein, individually, as a “ Sub-Field ”.

1.33.1 “ Ophthalmic Sub-Field ” shall mean any pharmaceutical product or medical device incorporating a Licensed Compound for applications in or on the eye in humans, including without limitation contact lens solutions and ophthalmic solutions containing a Licensed Compound as a preservative.

 

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1.33.2 “ Otic Sub-Field ” shall mean any pharmaceutical product or medical device incorporating a Licensed Compound for the prevention or treatment of infections in the ear in humans and solutions containing a Licensed Compound as a preservative for the ear in humans. For clarity, such pharmaceutical products or medical devices indicated for the treatment of otitis externa, including acute otitis externa (AOE), are considered products for the prevention or treatment of infections in the ear and thus a part of the Otic Sub-Field. (For purposes of this Agreement: “ infections ” shall include any infection, whether bacterial, viral, fungal or any combination thereof; and “ treatment ” of an infection shall include the reduction or elimination of biofilm associated with such infection.)

1.33.3 “ Sinus Sub-Field ” shall mean any pharmaceutical product or medical device incorporating a Licensed Compound for the prevention or treatment of infections in the paranasal sinuses in humans and solutions containing a Licensed Compound as a preservative for the paranasal sinuses in humans, but excluding products for the treatment or prevention of infections of the nares.

1.34 “ Filing Party ” shall have the meaning assigned in Section 6.2.3.

1.35 “ FTE ” shall mean a full time equivalent person year (consisting of a total of 1,880 hours per year) of scientific work on or related to the Discovery Research Program or Development Program. Scientific work on or related to the Discovery Research Program or Development Program shall include those tasks and activities described in the Discovery Research Plan or the Development Plans, as applicable, together with related managerial and preparation activities.

1.36 “ FTE Rate ” shall mean [***] per year per FTE, subject to adjustment as set forth in Section 8.2.

1.37 “ Funding Term ” shall mean the period commencing on the Effective Date and expiring on the later of: (i) the fourth (4 th ) anniversary of the Effective Date, or (ii) if Alcon elects to extend the Funding Term beyond the fourth (4 th ) anniversary of the Effective Date under Section 8.2.3, the end of the last Funding Term Extension so elected; provided that the Funding Term shall in all events terminate upon an earlier termination of this Agreement in accordance with Article 12.

1.38 “ Funding Term Extension ” shall have the meaning assigned in Section 8.2.3.

1.39 “ GAAP ” shall mean then-current generally accepted accounting principles in the United States as established by the Financial Accounting Standards Board or any successor entity or other entity generally recognized as having the right to establish such principles, in each case consistently applied.

 

[***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission.

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1.40 “ GLP ” shall mean the then-current good laboratory practice (or similar standards) for the performance of laboratory activities for pharmaceutical products as are required by any Regulatory Authority in the applicable jurisdiction.

1.41 “ GMP ” shall mean the then-current good manufacturing practice (or similar standards) for the manufacture of pharmaceutical products applicable to a Licensed Product as are required by the Regulatory Filings and approvals for such Product in the applicable jurisdiction, including any IND, MAA or Marketing Approval.

1.42 “ IND ” shall mean an investigational new drug application filed with the FDA as more fully defined in 21 C.F.R. §312.3 or similar application (i.e., a filing that must be made prior to commencing clinical testing in humans) filed with a Regulatory Authority in another jurisdiction.

1.43 “ IND Enabling Studies ” shall mean, with respect to Licensed Product for one or more particular indications in the Field, those studies that are reasonably necessary to file an IND for such Licensed Product with the applicable Regulatory Authority to initiate human clinical trials with such Licensed Product for such indications. Such studies shall include those designed to provide information on microbiology, pharmacology, safety (toxicology) and CMC (chemistry, manufacturing and controls). Additional information on in-vivo models of efficacy, PK (pharmacokinetics) and ADME (adsorption, distribution, metabolism and secretion) may also be included.

1.44 “ Indemnify ” shall have the meaning assigned in Section 11.4.1.

1.45 “ Infringing Product ” shall have the meaning assigned in Section 9.4.

1.46 “ Initiation ” shall have the meaning assigned in Section 8.3.1(b)(ii).

1.47 “ Know-How ” shall mean information and tangible materials comprising (i) ideas, discoveries, inventions, improvements or trade secrets, (ii) techniques, methods, formulas, processes and Data, and (iii) compositions of matter, including Licensed Compounds and Development Compounds, in each case that are reasonably necessary for the Development, Manufacture and Commercialization of a Licensed Product. Know-How shall not include any Patent rights with respect thereto.

1.48 “ Licensed Compound ” shall mean any Aganocide Compound that: (i) is Controlled by NovaCal as of the Effective Date, including NVC-101, NVC-422 and the compounds set forth on Exhibit 1.3; (ii) is Discovered by NovaCal during the Exclusivity Period; or (iii) is Controlled by NovaCal during the Exclusivity Period.

1.49 “ Licensed Product ” shall mean any (i) pharmaceutical product that incorporates a Development Compound as one of its ingredients, or (ii) medical device that that incorporates a Development Compound as one of its ingredients. For avoidance of doubt, references to Licensed Product shall include any formulation, delivery device, dispensing device or packaging required for effective use of the Licensed Product.

 

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1.50 “ Losses ” shall have the meaning assigned in Section 11.4.1.

1.51 “ Major Market ” shall mean any of the following: Canada, France, Germany, Italy, Spain, United Kingdom or the United States.

1.52 “ Manufacturing ” shall mean, with respect to Licensed Product in the Field, any and all processes and activities conducted for the GLP or GMP manufacture of such Licensed Product in final dosage form (but not the Development Compound (i.e., the active pharmaceutical ingredient) therein) for Development or Commercialization thereof, including formulating a Development Compound into the final dosage form of the Licensed Product incorporating such Development Compound, packaging, labeling and other finishing activities, quality control and assurance testing, formulation development and other activities performed in support of the CMC (chemistry, manufacturing and controls, or equivalent) section of an IND, in each case with respect to such Licensed Product. For clarity, Manufacturing shall exclude all Discovery, Development and Commercialization processes and activities, as well as process and activities directed to the manufacture of Development Compounds alone (i.e., not as part of a Licensed Product). “ Manufacture ” shall have the correlative meaning.

1.53 “M anufacturing Cost ” shall have the meaning assigned in Exhibit 6.1.4.

1.54 “ Marketing Approval ” shall mean, with respect to Licensed Product for a particular indication in a particular jurisdiction, approval by the applicable Regulatory Authority of an MAA for such Licensed Product for such indication, together with pricing approval in jurisdictions where pricing is established by the Regulatory Authority or other governmental agency. Notwithstanding the foregoing, if approval of such MAA is not required to market the Licensed Product in such jurisdiction, Marketing Approval shall be deemed to have occurred for a particular indication for a Licensed Product in such jurisdiction upon the first commercial sale of such Licensed Product in such jurisdiction with labeling for such indication.

1.55 “ Marketing Approval Application ” or “ MAA ” shall mean a New Drug Application (as defined in 21 C.F.R. § 314.50 et. seq.) or similar filing, or a comparable filing for authorization to initiate marketing activities in a jurisdiction other than the United States, in each case with respect to a Licensed Product in the Territory.

1.56 “ Marketing Partner ” shall mean a Third Party to whom a Party has granted rights to: (i) market and sell a Licensed Product on such Third Party’s own behalf; or (ii) promote, co-promote or otherwise offer to sell a Licensed Product on such Third Party’s own behalf. For clarity, a Marketing Partner shall not include: (A) any Third Party marketing or selling a Licensed Product on behalf of a Party (i.e. where such Party books sales and bears the risk of loss associated with non-payment); (B) any Third Party Manufacturing a Licensed Product for sale by a Party; or (C) any other subcontractor.

 

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1.57 “ Milestone Event ” shall have the meaning assigned in Section 8.3.

1.58 “ Milestone Payment ” shall have the meaning assigned in Section 8.3.

1.59 “ MTA ” shall have the meaning assigned in Section 13.6.

1.60 “ Net Sales ” shall mean the gross invoiced price for Licensed Products sold by Alcon, its Affiliates or a Marketing Partner (the “ Selling Party ”) to independent, unaffiliated Third Parties and recognized in the accounting records of the Selling Party as sales, less the following deductions from such gross amounts: (i) normal and customary trade, cash and other quantity discounts and allowances actually allowed and taken; (ii) credits or allowances actually granted to the customer for damaged goods, returns, recalls, rebates or rejections of Licensed Products; (iii) sales, use, excise or ad valorem taxes (to the extent borne by Selling Party and separately stated on the invoice and included in the computation of gross sales); (iv) Third Party cash rebates and chargebacks related to sales of the Licensed Product, to the extent allowed and taken by such Third Party; (v) freight, insurance and other transportation and handling fees to the extent included in the invoice price; (vi) retroactive price reductions that are actually allowed or granted to and taken by Third Parties; (vii) compulsory payments and rebates directly related to the sale of Licensed Products, accrued, paid, or deducted pursuant to agreements (including, but not limited to, managed care agreements) or government regulations; and (viii) any other specifically identifiable costs or charges included in the gross invoiced sales price of such Licensed Product substantially equivalent to those listed in clauses (i) – (vii) above. Only items that are deducted from Selling Party’s gross sales of Licensed Product(s), as included in Selling Party’s published financial statements and which are in accordance with GAAP, shall be deducted from such gross sales for purposes of the calculation of Net Sales. In the event that Alcon or its Affiliates or Marketing Partner make any adjustment to such deductions after the associated Net Sales have been reported pursuant to this Agreement, the adjustments and payment of any royalties due shall be reported with the next quarterly report.

1.60.1 Sales between or among Alcon, its Affiliates and Marketing Partners shall be excluded from the computation of Net Sales if such sales are not intended for end use, but Net Sales shall include the subsequent final sales to Third Parties by Alcon or any such Affiliates or Marketing Partners. A Licensed Product shall not be deemed sold if the Licensed Product is provided free of charge to a Third Party as a sample consistent with Selling Party’s normal promotional and sample practices in direct support of the Commercialization of the Licensed Product. In the event that a Licensed Product is sold in combination with one or more other stand-alone products that are not Licensed Products, then the Net Sales of such combined products shall be apportioned as reasonably agreed by the Parties based on prices normally charged to Third Parties for the Licensed Product and such other products.

1.60.2 If a sale, transfer or other disposition with respect to Licensed Products involves consideration other than cash or is not at arm’s length, then the Net Sales from such sale, transfer or other disposition shall be calculated on the fair market value of the consideration received as agreed by the Parties.

 

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1.61 “ Non-rejection ” shall have the meaning assigned in Section 8.3.1(b)(i).

1.62 “ Notifying Party ” shall have the meaning assigned in Section 7.4.3.

1.63 “ NovaCal Indemnities ” shall have the meaning assigned in Section 11.4.2.

1.64 “ NovaCal Marks ” shall have the meaning assigned in Section 5.6.

1.65 “ NovaCal Technology ” shall mean the NovaCal Patents and NovaCal Know-How, including without limitation any Know-How and Patents covering (i) inventions made by NovaCal in the course of performing activities under the Discovery Research Program and any Development Program, and (ii) formulations of Aganocide Compounds developed by NovaCal for use outside the Field.

1.65.1 “ NovaCal Know-How ” shall mean any and all Know-How Controlled by NovaCal during the Term that is necessary for the Development, Manufacture or Commercialization of a Licensed Product within the Field in the Territory.

1.65.2 “ NovaCal Patents ” shall mean any and all Patents Controlled by NovaCal during the Term claiming the composition or use of a Development Compound or that are otherwise necessary for the Development, Manufacture or Commercialization of Licensed Products incorporating such Development Compound, in each case within the Field in the Territory.

1.66 “ NVC-101 ” shall mean the hypochlorous acid preparation that is the subject of IND No. 67,792, which is referred to by NovaCal internally as NVC-101.

1.67 “ NVC-422 ” shall mean [***].

1.68 “ Other Party ” shall have the meaning assigned in Section 7.4.3.

1.69 “ Patent ” shall mean any of the following, whether existing now or in the future anywhere in the world: (i) any issued patent, including without limitation inventor’s certificates, substitutions, extensions, confirmations, reissues, re-examination, renewal or any like governmental grant for protection of inventions; and (ii) any pending application for any of the foregoing, including without limitation any continuation, divisional, substitution, continuations-in-part, provisional and converted provisional applications.

1.70 “ Phase II ” shall mean any human clinical trial where the principal purpose is to determine preliminary evidence of efficacy and safety or to establish a dose or dose range for Phase

 

[***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission.

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III clinical trials of a Licensed Product in a patient population that has the disease or condition being studied (for example as described in 21 C.F.R. §312.21(b) or, with respect to a jurisdiction other than the United States, a similar clinical study).

1.71 “ Phase III ” shall mean any human clinical trial that is intended to be a pivotal trial for seeking or obtaining a Marketing Approval or to otherwise establish safety and efficacy in patients with the indication being studied for purposes of filing an MAA (for example, as described in 21 C.F.R. §312.21(c), or, with respect to a jurisdiction other than the United States, a similar clinical study).

1.72 “ Plan ” shall have the meaning assigned in Section 2.4.

1.73 “ Post-Execution Affiliate ” shall have the meaning assigned in Section 7.4.3.

1.74 “ Prior and Subsequent ” shall have the meaning assigned in Section 8.3.1(d).

1.75 “ Prosecution and Maintenance ” shall have the meaning assigned in Section 9.2.1.

1.76 “ Regulatory Authority ” shall mean any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the Discovery, Development, Manufacture, Commercialization or other use (including the granting of Marketing Approvals) of any Licensed Product in any jurisdiction, including the FDA, European Medicines Evaluation Agency, and the Ministry of Health, Labor and Welfare in Japan.

1.77 “ Regulatory Filing ” shall mean any filing or application with any Regulatory Authority, including INDs and MAAs and authorizations, approvals or clearances arising from the foregoing, including Marketing Approvals, and all correspondence with the FDA or other relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the FDA or other relevant Regulatory Authority, in each case with respect to a Licensed Product.

1.78 “ Requesting Party ” shall have the meaning assigned in Section 10.4.2.

1.79 “ Sub-Field Wind-Down Period ” shall have the meaning assigned in Section 12.5.2(b).

1.80 “ Subject Transaction ” shall have the meaning assigned in Section 7.4.3.

1.81 “ Supply Agreement ” shall have the meaning assigned in Section 6.1.5.

1.82 “ Term ” shall have the meaning assigned in Section 12.1.

1.83 “ Territory ” shall mean all countries and territories of the world.

 

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1.84 “ Third Party ” shall mean any person or entity other than a Party or an Affiliate of a Party.

1.85 “ Third Party Claim ” shall have the meaning assigned in Section 11.4.1.

1.86 “ Third Party Technology ” shall have the meaning assigned in Section 9.5.1.

1.87 “ Valid Claim ” shall mean a claim of an issued and unexpired patent or a claim of a pending patent application within the NovaCal Patents which has not been held invalid or unenforceable by a court or other government agency of competent jurisdiction; provided, however, that if the holding of such court or agency is later reversed by a court or agency with overriding authority, the claim shall be reinstated as a Valid Claim with respect to Net Sales made after the date of such reversal.

ARTICLE 2

GOVERNANCE; COORDINATION

2.1 Coordination Committee .

2.1.1 Establishment . Promptly after the Effective Date, Alcon and NovaCal shall establish a joint, co-chaired coordination committee (the “ Coordination Committee ”) to review and coordinate the activities of the Parties under the Agreement, including the performance of the Discovery Research Program, Development Program and the Development, Manufacture and Commercialization of Licensed Products in the Field in the Territory.

2.1.2 Responsibilities . The Coordination Committee shall be responsible for: (i) providing strategic direction to the Parties’ activities under the Collaboration; (ii) reviewing and monitoring such activities and the progress thereof; (iii) managing the integration and coordination of the Discovery Research Program, Development Program (including the manufacture of Development Compounds and Licensed Products) and Commercialization of the Licensed Products; (iv) facilitating access to and the exchange of information between the Parties related to the Collaboration, the Development Compounds and Licensed Products; (v) establishing subcommittees as it deems appropriate to manage specific activities under the Collaboration and resolving disputes, disagreements and deadlocks of such subcommittees; and (vi) undertaking and/or approving such other matters as are specifically provided for the Coordination under the Agreement.

2.1.3 Membership . The Coordination Committee shall be comprised of an equal number of representatives from each of NovaCal and Alcon. Either Party may replace its respective Coordination Committee representatives at any time with prior notice to the other Party, provided that such replacement is of comparable authority and scope of functional responsibility within that Party’s organization as the person he or she is replacing. Unless otherwise agreed by the Parties, the Coordination Committee shall have at least one representative with relevant decision-making authority from each Party such that the Coordination Committee is able to effectuate all of its decisions within the scope of its responsibilities. Without limiting the foregoing, each Party shall

 

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appoint one of its members to the Coordination Committee to co-chair the meetings for the Coordination Committee (each, a “ Co-Chair ”). The Co-Chairs for the Coordination Committee shall (i) coordinate and prepare the agenda and ensure the orderly conduct of the Coordination Committee’s meetings, (ii) attend (subject to below) each meeting of the Coordination Committee, and (iii) prepare and issue minutes of each meeting within ten (10) business days thereafter accurately reflecting the discussions and decisions of the Coordination Committee. Such minutes from each Coordination Committee meeting shall not be finalized until the applicable Co-Chair from each Party has reviewed and confirmed the accuracy of such minutes in writing. The Co-Chairs shall solicit agenda items from the other Coordination Committee members and provide an agenda along with appropriate information for such agenda reasonably in advance (to the extent possible) of any meeting. It is understood that such agenda will include all items requested by either Co-Chair for inclusion therein. In the event the Co-Chair or another member of the Coordination Committee from either Party is unable to attend or participate in any meeting of the Coordination Committee, the Party who designated such Co-Chair or member may designate a substitute Co-Chair or other representative for the meeting.

2.2 Meetings . Unless otherwise agreed by the Parties, the Coordination Committee will meet at least quarterly during the Funding Term, and thereafter, the Coordination Committee will meet at least semiannually, in each case with at least one such meeting annually being face-to-face. Each Party shall be responsible for its own expenses relating to such meetings. As appropriate, other employee representatives of the Parties may attend Coordination Committee meetings as nonvoting observers, but no Third Party personnel may attend unless otherwise agreed by the Parties. Each Party may also call for special meetings to resolve particular matters requested by such Party.

2.3 Decision Making .

2.3.1 Alcon shall have the final say as to all decisions of the Coordination Committee relating to the designation of Development Compounds, the Development Plan, and the Commercialization Plan, as provided in Sections 3.4, 4.2 and 5.2 hereof, respectively. All other decisions of the Coordination Committee shall be made by consensus of the members present in person or by other means (e.g., teleconference) at any meeting, with at least one representative from each Party participating in such vote. In the event that the Coordination Committee is unable to reach consensus with respect to a particular matter, then either Party may, by written notice to the other, refer the matter to the respective Chief Executive Officers of the Parties or their designees for resolution by good faith discussions for a period of at least twenty (20) days. Unless the matter concerns pre-clinical or clinical development or manufacture of a Common Compound, Alcon’s Chief Executive Officer or his/her designee will have the right to make the final decision with respect thereto; provided that such deciding vote shall not extend to imposition of obligations on NovaCal under the Discovery Research Plan, the Development Plans or otherwise without NovaCal’s prior consent. If the matter concerns pre-clinical or clinical development or manufacture of a Common Compound and the Parties remain unable to resolve such dispute despite such good faith discussions, such matter shall be finally determined by binding arbitration in accordance with Section 2.3.2. Notwithstanding anything herein to the contrary, the Coordination Committee shall not have any authority to amend, modify or waive compliance with any term or condition of this Agreement.

 

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2.3.2 Any arbitration under this Section 2.3 or as otherwise provided in this Agreement shall be conducted by Judicial Arbitration and Mediation Services (“ JAMS ”) in Denver, Colorado in accordance with the applicable JAMS rules by a single arbitrator selected by mutual agreement of the Parties. If the Parties are unable to agree on an arbitrator, the arbitrator shall be selected by the chief executive of the Denver office of JAMS. For purposes of this Section 2.3.2, the arbitration shall be deemed to have been initiated as of the date the arbitrator has been selected. Each Party to the arbitration shall prepare a written proposal setting forth its position with respect to the substance of the dispute. Such written proposals shall be submitted to the arbitrator and exchanged by the Parties within ten (10) days subsequent to the initiation date, or sooner if so directed by the arbitrator. Without delaying the arbitration procedures, for a period not to exceed ten (10) days, commencing as of the date the written proposals have been submitted to the arbitrator and exchanged by the Parties, the Parties shall discuss the Parties’ respective written proposals in good faith in an effort to resolve the matter. The arbitrator shall select one of the requested positions as her/his decision, and shall not have authority to render any substantive decision other than to so select the position of one of the Parties. If one Party does not submit to the arbitrator a written proposal setting forth its position within the time period specified above, the arbitrator shall select the other Party’s position. The costs of such arbitration shall be shared equally by the Parties, and each Party shall bear its own expenses in connection with the arbitration. The Parties shall use good faith efforts to complete arbitration under this Section 2.3.2 within thirty (30) days following the initiation of such arbitration. The arbitrator shall establish reasonable additional procedures to facilitate and complete such arbitration within such thirty (30) day period. Nothing in this Agreement shall limit the right of either Party to seek to obtain in any court of competent jurisdiction any equitable or interim relief or provisional remedy, including injunctive relief.

2.4 Day-to-Day Responsibilities . Each Party shall: (i) be responsible for day-to-day implementation and operations of the Discovery, Development, Manufacturing and Commercialization activities with respect to Development Compounds and Licensed Products in the Field in the Territory for which it has or is otherwise assigned responsibility under the applicable Plan or this Agreement, provided that such decisions are not inconsistent with such Plan, other decisions of the Coordination Committee within the scope of their authority specified herein, or the express terms and conditions of this Agreement; and (ii) keep the other Party informed as to the progress of such activities, as reasonably requested by the other Party and as otherwise determined by the Coordination Committee. For purposes of this Agreement, “ Plan ” shall mean any of the Discovery Research Plan, Development Plan or the Commercialization Plan, in each case then-currently in effect.

2.5 Information Sharing . The Coordination Committee will act as the primary conduit for transfer and sharing between the Parties of information arising out of the Collaboration. Without limiting the foregoing, each Party will keep the other informed on a timely basis as to the plans for and results of the activities of the Collaboration. In addition, NovaCal will keep Alcon informed on a timely basis with respect to plans for and results of activities for Common Compounds outside of the Field.

 

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2.6 Coordination .

2.6.1 General . Subject to the exclusivity of efforts obligations set forth in Section 7.4, it is understood that NovaCal (itself or through its designees) shall have the right to perform Discovery activities with respect to Aganocide Compounds, and development, manufacture and commercialization activities with respect to Aganocide Compounds and products including any Aganocide Compound, including Licensed Compounds, for applications outside of the Field at NovaCal’s expense. Accordingly, the Parties, through the Coordination Committee, shall use good faith efforts to coordinate the Discovery of Aganocide Compounds under the Discovery Research Program and the Development of Licensed Products hereunder (including under the Development Program) with such activities of NovaCal (and its designees) outside the Field, so as to minimize the duplication of efforts and maximize quality and effectiveness of such activities, and avoid conflicts with Development Programs. Without limiting the foregoing and in order to facilitate coordination of the development of Common Compounds both inside and outside the Field, NovaCal shall keep Alcon informed on a timely basis with respect to development plans for Common Compounds to be conducted by or under authority of NovaCal, including proposed clinical plans and protocols, and give Alcon a reasonable opportunity to review and comment upon such proposed plans and protocols. Without limiting the Parties obligations under Sections 6.2 and 6.3, NovaCal agrees to keep Alcon, through the Coordination Committee, reasonably informed of its planned discovery activities and development activities outside of the Field with respect to products incorporating Development Compounds to allow for such coordination.

2.6.2 Supplemental Activities . In view of the foregoing, each Party will consider, in good faith, a request from the other Party to supplement planned development activities for Development Compounds inside or outside of the Field, as applicable, in order to generate Data that may be of benefit inside or outside of the Field, as applicable; provided that (i) such supplemental activities are not likely to have any material adverse effect or negative impact on the Discovery Research Program or Development Program hereunder, and (ii) the Party requesting such supplemental activities agrees to reimburse the other Party for any additional costs incurred by the other Party with respect to activities outside the scope of this Agreement.

2.6.3 Minimization of Substitutability . In order to reduce the chances that quantities of Licensed Products sold by Alcon or its Affiliates, Marketing Partners or distributors for use inside the Field will be used for any application outside the Field, and similarly that products incorporating Development Compounds sold for applications outside of the Field will be used for applications in the Field, the Parties shall work together in good faith, through the Coordination Committee to develop unique packaging, trademarks and names for Licensed Products in the Field and products containing Development Compounds outside of the Field, with the goal of reducing the risk of substitutability of Licensed Products in the Field with such products outside the Field. For clarity, nothing in this Section 2.6.3 is intended to limit or preclude any particular packaging, trademarks or names used for a Licensed Product in the Field or used for a product containing a Development Compound outside of the Field, but the Parties will use good faith in coordinating the same so as to reduce the risk of substitutability.

 

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ARTICLE 3

DISCOVERY RESEARCH PROGRAM

3.1 Discovery Research Program . During the Funding Term, NovaCal and Alcon shall conduct a program to Discover Aganocide Compounds for Development as Licensed Products for applications in the Field on a collaborative basis and in accordance with the Discovery Research Plan (the “ Discovery Research Program ”). The Discovery Research Program shall be coordinated by the Parties through the Coordination Committee. The Parties shall each conduct their responsibilities under the Discovery Research Program, as assigned to them under the Discovery Research Plan, throughout the Funding Term and shall use Commercially Reasonable Efforts to achieve the objectives and timelines within such Discovery Research Plan. The term of the Discovery Research Program shall commence on the Effective Date and expire on the expiration of the Funding Term; provided that the Discovery Research Program shall in all events terminate upon an earlier termination of this Agreement in accordance with Article 12.

3.2 Discovery Research Plan . The Discovery Research Program shall be carried out in accordance with a plan and budget covering the activities to be conducted by the Parties (“ Discovery Research Plan ”). The initial Discovery Research Plan shall be finalized by the Parties within sixty (60) days of the Effective Date, based upon the guidelines set forth in Exhibit 3.2 , and shall reference this Article 3 and this Agreement. The Discovery Research Plan shall govern the performance of the Discovery Research Program during the Funding Term, unless otherwise agreed by the Parties. The Coordination Committee shall review and update the Discovery Research Plan on an ongoing basis, but at least annually, during the Funding Term. Notwithstanding anything herein to the contrary, unless otherwise agreed by the Parties, the Discovery Research Plan shall provide for at least a number of NovaCal FTEs consistent with Alcon’s funding obligations under Section 8.2.

3.3 Resource Commitments . In conducting its activities under the Discovery Research Program, each Party agrees to use scientific, technical and other personnel who are sufficiently qualified and have the requisite skills to perform the research activities assigned to them. The Parties agree that NovaCal shall be primarily responsible for the activities under the Discovery Research Program.

3.4 Designation of Development Compounds . From time to time, either Party may recommend to the Coordination Committee a particular Licensed Compound for consideration as a Development Compound for Development as a Licensed Product hereunder, based on the profile of such Licensed Compound. Upon such designation by the Coordination Committee, each such Licensed Compound so designated shall be deemed a “ Development Compound .” Upon such recommendation to the Coordination Committee, each Party shall make available such information pertaining to the applicable Licensed Compound as the other Party may reasonably request from time to time to assist, as reasonably necessary to evaluate such Licensed Compound as a Development Compound hereunder. A Licensed Compound shall not be deemed a Development Compound unless so designated by the Coordination Committee; provided, however, if the Coordination Committee is unable to reach unanimous decision with respect to whether a particular

 

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Licensed Compound should be designated as Development Compound, then Alcon’s Coordination Committee Co-Chair shall have the right to designate such Licensed Compound as a Development Compound. Upon the designation of a Licensed Compound as a Development Compound, Alcon shall use Commercially Reasonable Efforts to promptly initiate activities under the Development Program therefor including proceeding to IND Enabling Studies for such Development Compound.

ARTICLE 4

DEVELOPMENT PROGRAM

4.1 Development .

4.1.1 General . For each Development Compound and subject to coordination through the Coordination Committee, Alcon shall fund, take the lead and be responsible for conducting such Development activities, including clinical trials, as may be reasonably necessary to expeditiously obtain Marketing Approvals for Licensed Products incorporating such Development Compound, for applications in the Field throughout the Territory, all in accordance with the Development Plan for such Development Compound.

4.1.2 Development Program . Without limiting the foregoing, NovaCal and Alcon shall conduct a program to Develop Licensed Products for applications in the Field on a collaborative basis and in accordance with the Development Plans (the “ Development Program ”); provided, unless otherwise mutually agreed by the Parties, NovaCal’s participation in the Development Program shall be limited to the Funding Term. The Development Program shall be coordinated by the Parties through the Coordination Committee. Alcon shall fund the Development Program, including NovaCal’s performance of activities thereunder as provided in Section 8.2. The Parties shall each conduct their responsibilities under the Development Program, as assigned to them under the Development Plans, in accordance with good scientific and clinical practice, and in compliance in all material respects with all applicable legal requirements and regulatory standards, and shall use Commercially Reasonable Efforts to achieve the objectives and timelines within the Development Plans.

4.2 Development Plan .

4.2.1 Establishment . The Coordination Committee shall have the responsibility for establishing a comprehensive, multi - year plan and budget for the Development of each Licensed Product in the Field in the Territory (each, a “ Development Plan ”). The initial Development Plan for each Licensed Product shall be finalized by the Parties within three (3) months of the date the Development Compound incorporated therein is designated a Development Compound in accordance with Section 3.4, and shall reference this Article 4 and this Agreement.

4.2.2 Contents . Each Development Plan shall fully describe the proposed activities related to preclinical studies, formulation development, clinical studies, regulatory plans (including Filing of INDs and MAAs) and other Development activities and timelines directed to obtaining Marketing Approval in each country encompassed by the Development Plan. In addition, Alcon shall

 

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provide NovaCal with such information as NovaCal may reasonably request from time to time, including, for example, copies of proposed trial protocols, clinical trial analyses and reports, and material correspondence with Regulatory Authorities with respect to each Licensed Product. In any event, and without limiting the foregoing, Alcon shall provide the Coordination Committee with a copy of the clinical plan and protocols for each proposed clinical trial for a Licensed Product reasonably in advance of the initiation of such activities, for review and comment by the Coordination Committee; however, Alcon will have the final say in the design and conduct of such clinical plan and clinical trials. Notwithstanding anything herein to the contrary, unless otherwise agreed by the Parties the Development Plans shall provide for at least a number of NovaCal FTEs consistent with Alcon’s funding obligations under Section 8.2.

4.2.3 Annual Review . After establishment of the initial Development Plan for a Development Compound, the Coordination Committee shall review and update such Development Plan at least annually and prior to any material modification or addition thereto, and in so doing shall consider the reasonable suggestions and comments of NovaCal with respect thereto.

ARTICLE 5

COMMERCIALIZATION OF LICENSED PRODUCTS

5.1 Commercialization . Subject to the terms and conditions of this Agreement, as between the Parties, Alcon shall have the exclusive (except as provided in Section 5.4 below) right to Commercialize Licensed Products in the Field in the Territory. Alcon shall Commercialize the Licensed Products in the Field in coordination with NovaCal through the Coordination Committee and in accordance with the Commercialization Plans. Without limiting the foregoing, Alcon agrees to use Commercially Reasonable Efforts (i) to launch Licensed Products in the Field as soon as practicable in the United States and other Major Markets, and thereafter (ii) to market, promote and sell such Licensed Products in the Field in the Territory to maximize Net Sales with respect thereto. It is understood and agreed that, except as otherwise expressly provided herein, all Commercialization efforts for the Licensed Products in the Field in the Territory shall be at the sole expense of Alcon.

5.2 Commercialization Plan . At least eighteen (18) months in advance of the launch of each Licensed Product, Alcon shall propose an initial plan for the Commercialization of such Licensed Product in the Field in the Territory (each, a “ Commercialization Plan ”), which Commercialization Plan shall be updated at least annually. Alcon shall provide each such Commercialization Plan and any material modification or addition thereto to the Coordination Committee for its review and comment. The Parties acknowledge that the comments of the Coordination Committee with respect to any Commercialization Plan are solely advisory in nature and that Alcon shall have the final say relative to the Commercialization Plan; nonetheless, Alcon shall consider in good faith the comments of NovaCal with respect thereto.

 

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5.3 Alcon Marketing Partners .

5.3.1 General . Subject to the terms and conditions of this Agreement, including Section 5.3.2 below, Alcon shall have the right, at any time with respect to territories outside of the Major Markets, and with respect to the Major Markets, beginning [***]after the first commercial sale of such Licensed Product within such Major Market, to grant sublicenses under its license set forth in Section 7.1.1(a) to one or more Marketing Partners. Alcon may grant such sublicenses to Marketing Partners earlier than [***] after such first commercial sale if Alcon obtains NovaCal’s prior written consent, which consent shall not be unreasonably withheld.

5.3.2 Conditions . Alcon shall only have the right to grant such sublicenses pursuant to Section 5.3.1 if all of the following conditions are satisfied:

(a) Any such sublicense shall be pursuant to a written agreement that is consistent with the terms hereof and Alcon shall be responsible for the compliance of such Third Party with the applicable terms of such agreement and of this Agreement;

(b) NovaCal and Alcon mutually agree (which agreement not to be unreasonably withheld or delayed by either Party) upon the terms and conditions of such arrangement with such Third Party, including the economics and other material terms (including the use of diligent efforts) thereof; and

(c) Such Third Party is reasonably acceptable to NovaCal, which acceptance may not be unreasonably withheld or delayed.

5.4 NovaCal Co-Marketing Partners .

5.4.1 Asia .

(a) General . Subject to the terms and conditions of this Agreement, including Section 5.4.1(b) below, NovaCal will have the right to appoint one Third Party (each, a “ Co-Marketing Partner ”) to market each Licensed Product for applications in the Otic Sub-Field or Sinus Sub-Field in each of the People’s Republic of China, Republic of China, South Korea, India and Japan, and such other Asian countries as NovaCal shall request and Alcon shall not unreasonably refuse (collectively, “ Asia ”).

(b) Conditions . NovaCal shall, unless otherwise agreed by the Parties, only have the right to grant such appointments pursuant to this Section 5.4.1 if all of the following conditions are satisfied:

(i) Any such appointment of a Co-Marketing Partner shall be pursuant to a written agreement that is consistent with the terms hereof, and NovaCal shall be responsible for the compliance of such Co-Marketing Partner with the applicable terms of such agreement and of this Agreement;

 

[***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission.

 

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(ii) Each Co-Marketing Partner will have the right to Commercialize Licensed Products under its own and NovaCal’s trademarks and logos but not Alcon’s trademarks and logos;

(iii) Each such Co-Marketing Partner shall (A) perform any Development of Licensed Products in the applicable territory in Asia in coordination with and subject to the oversight of the Coordination Committee and approval of Alcon (which approval shall not be unreasonably withheld, delayed or conditioned) and (B) agree to be responsible for [***]of all costs of the Development of such Licensed Products specific to such territory (before and after the execution of the agreement with such Co-Marketing Partner), including reimbursement of Alcon of appropriate amounts therefor;

(iv) Each such Co-Marketing Partner shall have the right to (A) use or cross-reference Alcon’s Regulatory Filings for such Licensed Products in such territory and (B) launch such Licensed Products simultaneously with or after Alcon’s launch of such Licensed Products in such territory;

(v) Each such Co-Marketing Partner (or NovaCal on its behalf) shall pay Alcon a royalty for so long as royalties are due to NovaCal for such Licensed Product under Section 8.4.5 and on terms and conditions substantially identical to those in Sections 8.4.6 – 8.10 ( mutatis mutandis ), and such royalty rate shall be [***] of such Co-Marketing Partners’ Net Sales of Licensed Product;

(vi) Alcon shall supply to NovaCal each such Co-Marketing Partner’s requirements of formulated and packaged (labeled or unlabeled, at Alcon’s discretion) Licensed Product in accordance with Section 6.1.3;

(vii) NovaCal’s co-marketing agreement with each such Co-Marketing Partner will ensure consistency and coordination of the Co-Marketing Partner’s marketing efforts and messages with respect to Licensed Products with that of Alcon (or its allowed designee);

(viii) The Co-Marketing Partner shall be subject to approval by Alcon, with such approval not to be unreasonably conditioned or delayed and may only be withheld

 

[***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission.

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if Alcon reasonably believes that NovaCal’s appointment of such Third Party is likely to put Alcon at a material commercial disadvantage with respect to other potential Co-Promotion Partners and provides NovaCal with reasonable written explanation of the basis for such belief within thirty (30) days of NovaCal notifying Alcon that it is contemplating such Third Party as a Co-Promotion Partner under this Section 5.4.1; and

(ix) NovaCal shall promptly provide Alcon with aggregate quarterly sales data that NovaCal receives from each Co-Marketing Partner for such Co-Marketing Partner’s sales of Licensed Product.

5.4.2 Underserved Markets .

(a) General . Subject to the terms and conditions of this Agreement, including Section 5.4.2(b) below, NovaCal will have the right to appoint one Co-Marketing Partner to market each Licensed Product in each Underserved Market in the Otic Sub-Field or Sinus Sub-Field. As used herein, “ Underserved Market ” shall mean, with respect to a particular Licensed Product in the Otic Sub-Field or Sinus Sub-Field, any territory in the world (other than Asia) where Alcon (itself or through its Affiliates or allowed Marketing Partners) is not committing sales and marketing resources reasonably sufficient for the promotion, marketing and sales of such Licensed Product in such Sub-Field. For such purposes, Alcon’s commitment of such resources and personal shall be deemed not to be “ reasonably sufficient ” if at such time Alcon has not committed at least the number and level of promotional effort of sales representatives devoted to promoting and selling such Licensed Product as other pharmaceutical companies of similar size commit to their pharmaceutical products with similar market potential, financial value, and number of potential prescribing physicians in such territory.

(b) Conditions . NovaCal shall, unless otherwise agreed by the Parties, only have the right to grant such appointments pursuant to this Section 5.4.2 if all of the following conditions are satisfied:

(i) Any such appointment of a Co-Marketing Partner shall be pursuant to a written agreement that is consistent with the terms hereof, and NovaCal shall be responsible for the compliance of such Co-Marketing Partner with the applicable terms of such agreement and of this Agreement;

(ii) Each Co-Marketing Partner will have the right to Commercialize Licensed Products under its own and NovaCal’s trademarks and logos but not Alcon’s trademarks and logos;

(iii) Each such Co-Marketing Partner shall have the right to (A) use or cross-reference Alcon’s Regulatory Filings for such Licensed Products in such territory and (B) launch such Licensed Products simultaneously with or after Alcon’s launch of such Licensed Products in such territory;

 

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(iv) Alcon shall supply such Co-Marketing Partners’ requirements of formulated and packaged (but not labeled) Licensed Product in accordance with Section 6.1.3;

(v) Each such Co-Marketing Partner (or NovaCal on its behalf) shall reimburse Alcon for Alcon’s development expenses applicable to such Underserved Market and pay Alcon a royalty for so long as royalties are due to NovaCal for such Licensed Product under Section 8.4.5 and on terms and conditions substantially identical to those in Sections 8.4.6 – 8.10 ( mutatis mutandis ), and such royalty rate shall be [***]of such Co-Marketing Partners’ Net Sales of Licensed Product.

(vi) NovaCal’s co-marketing agreement with such Co-Marketing Partner will (A) not allow such Co-Marketing Partner to perform Development with respect to any Licensed Product, except as overseen by the Coordination Committee and approved by Alcon (which approval shall not be unreasonably withheld, conditioned or delayed); and (B) ensure consistency and coordination of its marketing efforts and messages with respect to Licensed Products with that of Alcon (or its allowed designee) in the applicable territory;

(vii) The Co-Promotion Partner shall be subject to approval by Alcon, with such approval not to be unreasonably conditioned or delayed and may only be withheld if Alcon reasonably believes that NovaCal’s appointment of such Third Party is likely to put Alcon at a material commercial disadvantage with respect to other potential Co-Promotion Partners and provides NovaCal with reasonable written explanation of the basis for such belief within thirty (30) days of NovaCal notifying Alcon that it is contemplating such Third Party as a Co-Promotion Partner under this Section 5.4.2; and

(viii) NovaCal shall notify Alcon in advance of NovaCal’s intent to appoint any such Co-Marketing Partner and afford Alcon [***] to agree in writing to commit sufficient sales and marketing resources within the applicable territory so that it would no longer qualify as an Underserved Market.

5.5 Cooperation and Consultation . Each Party agrees to cooperate and consult with the other Party in good faith, at such other Party’s request, with respect to the activities contemplated in Sections 5.3 or 5.4, as applicable.

5.6 NovaCal Logo . Alcon hereby agrees to the extent allowable under applicable law to include on all labels of and package inserts and marketing materials for Licensed Product(s) sold by or under authority of Alcon to include NovaCal’s trade name and logo (collectively, the “ NovaCal Marks ”). It is understood that such inclusion (including the size and placement) of the NovaCal Marks shall be consistent with Alcon’s past practices for similarly situated Third Party logos.

 

[***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission.

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Accordingly, NovaCal hereby grants to Alcon a non-exclusive, royalty-free license to use the NovaCal Marks solely in connection with the marketing, promotion and sale of the Licensed Product(s) in the Field hereunder. Alcon shall ensure that use of the NovaCal Marks is consistent with high levels of business professionalism and product quality and reasonable written guidelines provided from time to time by NovaCal. All ownership and goodwill arising out of the use of the NovaCal Marks shall vest in and inure solely to the benefit of NovaCal. Notwithstanding anything herein to the contrary, upon NovaCal’s written request, Alcon, its Affiliates and Marketing Partners agree to cease the use of the NovaCal Marks; provided (i) that Alcon, its Affiliates and Marketing Partners may continue to use any labels, package inserts and marketing materials in existence as of the receipt of such notice and (ii) in such case Alcon’s obligation to include the NovaCal Marks on labels, package inserts and marketing materials for Licensed Product(s) shall terminate.

ARTICLE 6

MANUFACTURING AND SUPPLY, REGULATORY & OTHER MATTERS

6.1 Manufacturing and Supply .

6.1.1 Development Compounds . Unless otherwise agreed by the Parties, NovaCal shall have the right and responsibility (itself or through one or more Third Parties) for manufacturing and supplying Development Compounds to Alcon for use in all Development activities up through the initiation of the first Phase II clinical trial for a Licensed Product in the Field incorporating such Development Compound.

(a) Subject to the foregoing provisions of this Section 6.1.1, if such Development Compound is a Common Compound, then NovaCal shall have the right and responsibility (itself or through one or more Third Parties) to manufacture and supply such Development Compound to Alcon for use in all other Development activities as well as all Commercialization activities hereunder; provided that Alcon shall reimburse NovaCal for [***] of the costs associated with process development, scale-up, quality assurance and quality control testing and monitoring, stability studies, qualification, validation and other similar activities with respect to the manufacture of such Development Compound, such costs to be verified by audit at Alcon’s election and expense. In the event such NovaCal costs are audited and the audit reveals that such costs were overstated by more than ten percent (10%), then the audit expenses shall be paid by NovaCal.

(b) Subject to the foregoing provisions of this Section 6.1.1, if such Development Compound is not a Common Compound, Alcon shall have the right and responsibility (itself or through one or more Third Parties) to manufacture and supply such Development Compound for use in all other Development activities as well as all Commercialization activities hereunder.

 

[***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission.

 

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(c) For clarity, NovaCal shall not have any obligation to supply or have supplied any GMP material for a Licensed Compound unless and until such time as such Licensed Compound has been designated a Development Compound in accordance with Section 3.4 above.

6.1.2 Licensed Products . In all events, Alcon shall have a right and the responsibility to Manufacture (itself or through one or more Third Parties) any Licensed Product (i.e., formulate or compound the Development Compound and otherwise produce the final dosage forms thereof) in the Field, for use in its Development and Commercialization activities in the Field under this Agreement.

6.1.3 Supply by Alcon .

(a) If Alcon is manufacturing or having manufactured any Licensed Product, then, upon request by NovaCal, Alcon will manufacture or have manufactured, to the extent Alcon has unallocated capacity therefor or right to order (or NovaCal agrees to reimburse Alcon to establish such additional capacity), and supply such Licensed Product for use by NovaCal (or NovaCal’s Co-Marketing Partners) in accordance with this Agreement.

(b) If Alcon is manufacturing or having manufactured any Development Compound, then, upon request by NovaCal, Alcon will manufacture or have manufactured, to the extent Alcon has unallocated capacity therefor or right to order (or NovaCal agrees to reimburse Alcon to establish such additional capacity), and supply such Development Compound for use by NovaCal (or NovaCal’s Co-Marketing Partners) in accordance with this Agreement and for use outside of the Field.

(c) For the avoidance of doubt, Alcon’s obligation to supply Development Compound or Licensed Product under this Section 6.1.3 does not apply to NovaCal’s (or its Third Party partner’s) pursuit of an Identified Opportunity pursuant to Sections 7.2.1(b) or 7.2.1 (c), and Alcon’s obligation to supply Licensed Products under subparagraph (a) above is only applicable to the Field.

6.1.4 Transfer Price .

(a) The transfer price of Development Compounds supplied by either Party pursuant to this Section 6.1 will be equal to (i) the supplying Party’s Manufacturing Cost therefor with respect to supplies to be used for development and other non-commercialization activities and (ii) the supplying Party’s Manufacturing Costs therefor plus [***]with respect to supplies to be used for commercialization activities.

 

[***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission.

 

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(b) The transfer price of Licensed Products supplied by either Party pursuant to this Section 6.1 will be equal to (i) the supplying Party’s Manufacturing Cost therefor with respect to supplies to be used for development and other non-commercialization activities and (ii) the supplying Party’s Manufacturing Costs therefore [***] with respect to supplies to be used for commercialization activities.

For purposes of this Agreement, “ Manufacturing Cost ” has the meaning as set forth in Exhibit 6.1.4 .

6.1.5 Supply Agreement . Upon request by either Party, the Parties shall use good faith efforts to promptly negotiate and execute a definitive supply agreement setting forth the specific terms and conditions of any supply arrangement between the Parties pursuant to this Section 6.1 (each, a “ Supply Agreement ”). Each Supply Agreement shall (i) contain reasonable and customary supply terms (e.g., specifications, forecasts, lead times, purchase obligations and the like), (ii) be consistent with the terms hereof, and (iii) include the other terms and conditions set forth in Exhibit 6.1.5 .

6.1.6 Coordination . Each Party agrees to reasonably cooperate with the other with regard to the manufacture and supply of Development Compounds hereunder so as to minimize costs associated therewith, including when approaching Third Parties regarding potentially acting as a contract manufacturer for one or more Development Compounds. Upon either Party’s reasonable request, the Parties shall discuss and cooperate in good faith to provide for alternate or additional Third Party contract manufacturers to support the fulfillment of its supply obligations hereunder.

6.2 Regulatory Matters .

6.2.1 Filings .

(a) As between the Parties, Alcon shall take the lead and be responsible for, at its expense, filing, obtaining and maintaining approvals for Development, Manufacturing and Commercialization of Licensed Products in the Field in the Territory, including any IND, MAA or Marketing Approval therefor; provided that NovaCal shall be responsible for filing, obtaining and maintaining permits and approvals with respect to its supply of Development Compounds pursuant to Section 6.1, and Alcon shall be responsible for filing, obtaining and maintaining permits and approvals with respect to its manufacture and supply of Development Compounds and Licensed Products pursuant to Section 6.1. Notwithstanding the foregoing, Alcon shall afford representatives

 

[***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission.

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of NovaCal a reasonable opportunity to comment on Regulatory Filings for such Licensed Product, and shall reasonably consider such comments.

(b) To the extent not prohibited by applicable laws, rules or regulations, Alcon shall own all Regulatory Filings filed by or on behalf of it for Licensed Products in the Field in the Territory. Each Party shall promptly provide the other Party with reasonable advance notice (to the extent practicable) of meetings with the FDA or other relevant Regulatory Authority that pertain to Licensed Products in the Field.

6.2.2 Clinical Safety Reporting; Pharmacovigilance . With respect to any Adverse Drug Reaction, IND safety report or similar obligation to report to any Regulatory Authority relating to any safety issue with respect to Licensed Products in the Field, Alcon shall be responsible for and shall establish operating procedures to report to the appropriate Regulatory Authority(ies) all such matters in accordance with applicable laws, rules and regulations. Such operating procedures shall include any measures necessary for each Party to fully comply with such laws, rules and regulations. Such operating procedures and any material revisions to them shall be provided to the Coordination Committee for review and comment. The Parties agree to implement prior to the initiation of the first clinical trial for a Licensed Product in the Field, a separate agreement setting forth the responsibilities and procedures for clinical safety information exchange and reporting. In addition, the Parties agree to implement prior to the first launch of a Licensed Product in the Field, a separate agreement setting forth the pharmacovigilance responsibilities and procedures for safety information exchange and reporting. Such agreements shall include provisions requiring each Party promptly communicate to the other Party any correspondence related to the safety of Licensed Products in the Field to or from any Regulatory Authority. Such agreements shall also include coordination of reporting and correspondence related to safety matters with respect to products incorporating Development Compounds for applications outside of the Field. Without limiting the foregoing, the strategy and content of all responses to any questions from any such Regulatory Authority related to such matters received by either Party shall be subject to review and comment by the Coordination Committee (to the extent practical given the time-frames involved).

6.2.3 Cooperation . Each Party agrees to make its personnel reasonably available, upon reasonable notice to the other Party, at their respective places of employment to consult with the other Party on issues arising related to the activities conducted in accordance with this Section 6.2 or otherwise relating to regulatory matters involving the Licensed Products in the Field including any request from any Regulatory Authority, including regulatory, scientific, technical and clinical testing issues, or otherwise, throughout the Term. Without limiting the foregoing or Section 6.3 below, each Party (the “ Enabling Party ”) agrees to cooperate with the other (the “ Filing Party ”), at its request, to comply with specific requests of any Regulatory Authority (such as requests to inspect clinical trial sites), with respect to Data supplied or to be supplied by the Enabling Party to the Filing Party for filing with such Regulatory Authority, or with respect to Development Compounds supplied by the Enabling Party. The Enabling Party shall ensure that its contractors likewise comply with this Section 6.2.3. In this regard, the Enabling Party agrees to provide to applicable Regulatory Authorities, or provide reference rights to the Filing Party, Manufacturing data (including such information as is required for the CMC section of an IND or NDA, or a drug master file) specifically

 

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requested by the Filing Party, which is reasonably necessary for the Filing Party to obtain, proceed towards and/or maintain Regulatory Approval for the Licensed Products worldwide.

6.3 Transfer of Data and Regulatory Filings . From time to time, or upon reasonable request, each Party shall transfer to the other Party all previously undisclosed Data and Regulatory Filings relating to the Licensed Products that are Controlled by it, provided that NovaCal and Alcon shall have the right to redact any proprietary information that is not NovaCal Technology or Alcon’s proprietary technology, respectively, therefrom. Without limiting the foregoing, each Party shall have the right to (and authorize permitted Third Parties to) access, use and reference the other Party’s Data and reference the other Party’s Regulatory Filings for Development Compounds or Licensed Products for purposes of performing activities under the Collaboration, and with respect to NovaCal, for purposes of NovaCal (or subject to Sections 7.1.3 and 7.2 NovaCal’s designees) performing activities outside the Field, including the right to file such items with Regulatory Authorities. Each Party shall provide the other with such assistance as the other Party reasonably requests from time to time, to enable such other Party to fully understand and implement the Data and Regulatory Filings transferred under this Section 6.3. Notwithstanding anything herein to the contrary, in all agreements with Third Parties or Affiliates involving Data, NovaCal and Alcon, respectively, shall require that such Third Parties and Affiliates provide the other Party access to all such Data, to the extent reasonably necessary to fulfill its obligations or exercise the rights granted to it hereunder.

ARTICLE 7

LICENSES AND EXCLUSIVITY

7.1 License Grants .

7.1.1 To Alcon .

(a) Subject to the terms and conditions of this Agreement, including Section 6.1, NovaCal hereby grants to Alcon, an exclusive (except as otherwise provided in and subject to Section 5.4) license under the NovaCal Technology to Develop, Manufacture and Commercialize Licensed Products, in each case solely for applications in the Field in the Territory. The license granted under this Section 7.1.1(a) shall not include the right to sublicense (except to a Marketing Partner as provided in Section 5.3 or to an Affiliate); provided, however, that the use by Alcon of subcontractors shall not be construed as a sublicense. Alcon shall have the right to exercise such license through its Affiliates solely for as long as such entity remains an Affiliate of Alcon, and Alcon shall remain responsible for the compliance of such Affiliate with the applicable terms of this Agreement.

(b) Additionally subject to the terms and conditions of this Agreement, NovaCal hereby grants to Alcon a non-exclusive license to make, use and otherwise exploit subject matter within the NovaCal Technology to the extent necessary to conduct the activities assigned to Alcon under the Discovery Research Plan or otherwise cooperate with NovaCal hereunder. The license granted under this Section 7.1.1(b) shall not include the right to sublicense; provided,

 

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however, that the use by Alcon of subcontractors or delegation of responsibilities to an Affiliate shall not be construed as a sublicense.

7.1.2 To NovaCal .

(a) Subject to the terms and conditions of this Agreement, Alcon hereby grants to NovaCal a non-exclusive license to make, use and otherwise exploit subject matter within the Know-How and Patents Controlled by Alcon to the extent necessary to conduct the activities assigned to NovaCal under the Discovery Research Plan and Development Plan or otherwise cooperate with Alcon hereunder. The license granted under this Section 7.1.2(a) shall not include the right to sublicense; provided, however, that the use by NovaCal of subcontractors or delegation of responsibilities to an Affiliate shall not be construed as a sublicense.

(b) Additionally, subject to the terms and conditions of this Agreement, Alcon hereby grants to NovaCal a non-exclusive, worldwide, license, to make, use, sell, offer for sale, import and otherwise exploit products incorporating Licensed Compounds for applications outside the Field (as may be modified as a result of Section 12.2) under Know-How and Patents Controlled by Alcon related to such Licensed Compounds (including formulations and methods of manufacture thereof). Prior to the exercise of such license with respect to particular Know-How or Patents Controlled by Alcon, NovaCal shall provide written notice to Alcon. Upon such notice, the Parties shall negotiate in good faith the consideration to be paid by NovaCal for each such license; provided that the consideration payable to Alcon for each such license pursuant to this Section 7.1.2(b) shall not exceed [***] of net sales of products covered by the subject Patents or incorporating the subject Know-How outside the Field and shall not exceed [***] for all such licenses. Notwithstanding the foregoing, NovaCal shall not have the right to exercise the licenses granted pursuant to this Section 7.1.2(b) with respect to Know-How or Patents in a manner that can reasonably be expected to (i) create a risk of substitutability of the type contemplated in Section 2.6.3 hereof, or (ii) otherwise compete with Alcon products in the ophthalmic, otic and nasal fields.

7.1.3 Non-human Indications . Alcon acknowledges that the Field does not include applications for non-human species; however, nothing in this Agreement will prevent (a) Licensed Product indicated for human use to be sold and used in other species, and (b) NovaCal from granting rights for use of the Aganocide Compounds to a Third Party in any and all non-human indications. For clarity, except as otherwise required by applicable law, rule or regulation, or by any Regulatory Authority, NovaCal will not have the right to use any Data or Regulatory Filings developed or provided by Alcon hereunder in connection with the development of any products incorporating Aganocide Compounds for use in non-human indications where such products would be in the Field if such indications were human indications or otherwise to support the filing or maintenance of Regulatory Filings with respect thereto.

 

[***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission.

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7.1.4 No Other Active Ingredients . For clarity, it is understood that (i) the licenses granted to Alcon under Section 7.1.1 shall only apply to Licensed Products incorporating Development Compound(s) alone or in combination with one or more active ingredients (which are not Development Compounds), provided that such license shall not include any license to such active ingredients themselves; and (ii) the licenses granted to NovaCal under Sections 7.1.2(b), 12.5.1(d), and 12.5.2(d) shall only apply to products that contain any Licensed Compound(s) alone or in combination with one or more other active ingredients (which are not Licensed Compounds), provided that such license shall not include any license to such active ingredients themselves.

7.2 Identified Opportunities .

7.2.1 Alcon or NovaCal may identify to the Coordination Committee specific proposed applications of a Licensed Compound within the Field (other than the use of a Licensed Product for the prevention or treatment of infections) (each, an “ Identified Opportunity ”). The Coordination Committee shall evaluate each such Identified Opportunity and determine in writing within sixty (60) days of the date such Identified Opportunity is first identified to it, whether it agrees that the subject Identified Opportunity justifies an investigation on the part of Alcon. If Alcon agrees that subject Identified Opportunity justifies an investigation on the part of Alcon, then NovaCal will provide reasonably sufficient quantities (as determined by the Coordination Committee) of the applicable Licensed Compound(s) to enable Alcon to evaluate the Identified Opportunity, and Alcon will have a reasonable period of time (as determined by the Coordination Committee, but in no event more than [***] following the first receipt of such Licensed Compound(s) from NovaCal or such other period as may be mutually agreed between the Parties through the Coordination Committee) (the “ Evaluation Period ”) to use Commercially Reasonable efforts to evaluate such Identified Opportunity.

(a) If Alcon (i) through the Coordination Committee does not agree that the subject Identified Opportunity justifies an investigation, (ii) notifies NovaCal within the Evaluation Period that Alcon is not interested in pursuing Development and Commercialization of the subject Identified Opportunity hereunder, or (iii) fails to provide any notification to NovaCal as to Alcon’s interest prior to the end of the Evaluation Period, then, upon written notification from NovaCal to the Coordination Committee, such Identified Opportunity shall be excluded from the Field for all purposes of the Agreement, and NovaCal shall be free to develop and commercialize, alone or with a Third Party partner, Licensed Products for that particular Identified Opportunity; provided that NovaCal or its Third Party partner shall not have the right to use any Patents or Know-

 

[***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission.

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How Controlled by Alcon (unless jointly owned by NovaCal as provided in Section 9.1.1) or, except as otherwise required by applicable law, rule or regulation, or by any Regulatory Authority, have the right to use any Data or Regulatory Filings developed or provided by Alcon hereunder in connection with the development of any pharmaceutical product incorporating an Aganocide Compound for such Identified Opportunity or otherwise to support the filing or maintenance of Regulatory Filings with respect thereto.

(b) If Alcon notifies NovaCal that it is interested in pursuing the Development and Commercialization of the applicable Identified Opportunity prior to the expiration of the Evaluation Period, then Alcon shall have up to [***] following such notice to determine its commercial interest and to agree upon commercial terms and diligence requirements with NovaCal for the further Development and Commercialization of Licensed Products for such Identified Opportunity, subject to the provisions of subparagraph (c) below, and the following shall apply:

(i) The Parties shall negotiate in good faith one or more milestone payments and a royalty that shall be appropriate for the particular Identified Opportunity, which milestone payment(s):(A) shall not exceed, in total, [***] of the total of the amounts described in Section 8.3 for the applicable Sub-Field and (B) shall be [***] relative to said Sub-Field. For clarity, the total, aggregate amounts payable to NovaCal as milestone payments for all applications in a particular Sub-Field shall not exceed [***], regardless of the number of applications pursued by Alcon in that Sub-Field (i.e., if the particular Identified Opportunity is developed by Alcon before the first anti-infective Licensed Product in the applicable Sub-Field, any negotiated milestone payments for that Identified Opportunity paid by Alcon to NovaCal shall be [***]).

(ii) In the case of a Licensed Product for an Identified Opportunity consisting solely of a contact lens solution (i.e., a non-pharmaceutical indication): (A) the milestone shall be the earlier of submission to the FDA of an application to market a Licensed Product for such Identified Opportunity or the first commercial launch of such Licensed Product in the United States for such Identified Opportunity, and the [***] with respect thereto shall be [***]; provided that, if any event substantially equivalent to such milestone is achieved in any jurisdiction outside of the United States prior to achievement of such milestone in the United States, Alcon shall pay to NovaCal [***] of such milestone payment at such time, with the remaining [***] payable to NovaCal upon the achievement of such milestone in the United States; and (B) the royalty rate for a Licensed Product for such Identified Opportunity shall be equal to [***] of Net Sales of such Licensed Product.

(iii) In the case of a Licensed Product for an Identified Opportunity incorporating a Licensed Compound solely as a preservative, the royalty rate shall be negotiated in

 

[***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission.

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good faith by the Parties as specified in subsection (i) above, but in no event exceed [***] of Net Sales of such Licensed Product.

(iv) In the case of Licensed Products for an Identified Opportunity other than those described in subsections (ii) and (iii) above, the royalty rate shall be negotiated in good faith by the Parties, but in no event exceed [***] of Net Sales of such Licensed Product.

(v) If after such [***] period, the Parties cannot agree upon the commercial terms and diligence requirements for the further Development and Commercialization of a particular Identified Opportunity hereunder, NovaCal shall have the right to give written notice to Alcon and such Identified Opportunity shall be excluded from the Field for all purposes of the Agreement, and NovaCal shall be free to develop and commercialize, alone or with a Third Party partner, Licensed Products for that particular Identified Opportunity; provided that NovaCal or its Third Party partner shall not, except as otherwise required by applicable law, rule or regulation, or by any Regulatory Authority, have the right to use any Patents or Know-How Controlled by Alcon (unless jointly owned by NovaCal as provided in Section 9.1.1), or any Data or Regulatory Filings developed or provided by Alcon hereunder in connection with the development of any pharmaceutical product incorporating an Aganocide Compound for such Identified Opportunity or otherwise to support the filing or maintenance of Regulatory Filings with respect thereto.

(c) Notwithstanding the foregoing, Alcon shall not be obligated to pursue Development of more than [***] Identified Opportunities in each Sub-Field at the same time. In the event Alcon is already engaged in the Development of [***] Identified Opportunities in a Sub-Field as of the expiration of the [***] period specified in subparagraph (b) above, said [***] period shall be tolled until such time as Alcon’s existing Development efforts with respect to [***] such Identified Opportunity in the applicable Sub-Field have either been completed or abandoned.

7.3 No Other Rights . Each Party acknowledges that the rights and licenses granted under this Article 7 and elsewhere in this Agreement are limited to the scope expressly granted. Accordingly, except for the rights expressly granted under this Agreement, no right, title, or interest of any nature whatsoever is granted whether by implication, estoppel, reliance, or otherwise, by either Party to the other Party. All rights with respect to Know-How, Patent or other intellectual property rights that are not specifically granted herein are reserved to the owner thereof.

7.4 Exclusivity of Efforts .

7.4.1 Alcon . During the Exclusivity Period, Alcon shall not conduct, participate in or sponsor, directly or through any Affiliate of Alcon, either alone or with any Third Party, any activities directed toward the discovery, development or commercialization of any Aganocide Compound, except in each case pursuant to the Discovery Research Program, Development Program or as a Licensed Product in accordance with the terms of this Agreement.

7.4.2 NovaCal . During the Exclusivity Period, NovaCal shall not conduct, participate in or sponsor, directly or through any Affiliate of NovaCal, either alone or with any Third

 

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Party, any activities directed toward the discovery, development or commercialization of any Aganocide Compound for any application in the Field, except in each case pursuant to the Discovery Research Program, Development Program or as a Licensed Product in accordance with the terms of this Agreement.

7.4.3 Post Effective Date Affiliates . In the event a Party enters into any transaction (a “ Subject Transaction ”) whereby a Third Party that is engaged in activities that are prohibited under Section 7.4 above (such activities, a “ Competing Program ”) becomes an Affiliate of such Party after the Effective Date (such Affiliate, a “ Post-Execution Affiliate ”), then such Party (the “ Notifying Party ”) shall provide notice to the other Party (for purposes of this Section 7.4.3, the “ Other Party ”), within five (5) business days of the closing of the Subject Transaction, specifying the identity of the Post-Execution Affiliate and describing in reasonable detail, to the extent permitted by law and without disclosing any proprietary information, the Competing Program and its focus. Such notice shall also state whether the Notifying Party elects to: (i) include all or part of the Competing Program within the activities under this Agreement on the terms and conditions herein, (ii) Divest all or any portion of the Competing Program not so included within the activities under the Agreement; or (iii) keep separate all or any portion of the Competing Program not so included within the activities under the Agreement (if the Notifying Party does not include all of the Competing Program within the activities under this Agreement, the portion of such Competing Program not so included shall be Divested under subsection (ii) or kept separate under subsection (iii)); provided that:

(a) the Notifying Party shall not have the right to make the election under clause (iii) above if twenty percent (20%) or more of the Post-Execution Affiliate’s business consists of the Competing Program (as measured by percentage of research and development spend or revenue with respect to the Competing Program when compared to the other assets of the Post-Execution Affiliate’s business), or

(b) in the event of the Notifying Party elects the option described in clause (iii), then (I) the Notifying Party shall not have the right to exercise any of its rights or fulfill any of its obligations hereunder through such Post-Execution Affiliate, (II) such Post-Execution Affiliate shall not receive any license or other right under the NovaCal Technology or Data for any application in the Field, (III) the Other Party shall not have any license under any Patents or Know-How controlled by the Post-Execution Affiliate that was not licensed to the Other Party prior to the Subject Transaction, (IV) the Notifying Party shall maintain capacity and resources at least equivalent to those that were applied by the Notifying Party to activities under the Agreement or that are reasonably necessary for the Notifying Party to fulfill its obligations hereunder, to the extent the Notifying Party was required to maintain such capacity and resources had the Subject Transaction not occurred, and (V) the Notifying Party shall use its best efforts to put procedures in place to separate its activities under this Agreement and the Competing Program including preventing any disclosure of the Confidential Information of the Other Party to the Post-Execution Affiliate and to prevent receipt or use for activities under the Agreement of any technology or proprietary information of the Post-Execution Affiliate.

 

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(c) For purposes of this Section 7.4.3, “ Divest ” shall mean, with respect to a Competing Program, (x) the sale, license (exclusive in the Field) or other transfer of all of the right, title and interest in and to such Competing Program in the Field, including all technology, intellectual property and other assets relating solely thereto, to an independent Third Party (other than the Post-Execution Affiliate), without the retention or reservation of any rights, license or interest (other than solely an economic interest) within the Field by the Notifying Party or Post-Execution Affiliate in such Competing Program and (y) the complete shut down of the Competing Program such that no technology, intellectual property or other asset relating thereto is used by the Notifying Party or its Affiliates and delivery of written confirmation from the Notifying Party to the Other Party that the Notifying Party and its Affiliates covenant not to use any technology, intellectual property and assets solely relating to such Competing Program during the Exclusive Period.

7.5 Use of NovaCal Technology . Notwithstanding Section 7.1 above, Alcon agrees not to use any NovaCal Technology to research (including Discover), develop or commercialize Aganocide Compounds, other than as a Licensed Product under this Agreement; nor shall Alcon use any NovaCal Technology for any other purpose.

7.6 Conflicts of Interest . In carrying out its responsibilities under the Collaboration, each Party agrees to act in the best interests of the Licensed Products. Without limiting the foregoing, if Alcon or its Affiliate or Marketing Partner sells a Licensed Product to a Third Party to whom it also provides other products or services, Alcon or such Affiliate or Marketing Partner (as applicable) shall not price, discount or otherwise offer (including bundling) the Licensed Product in any way that benefits such other products or services at the expense of such Licensed Product or otherwise disadvantage the Licensed Products. Similarly, if a NovaCal Co-Marketing Partner sells a Licensed Product to a Third Party to whom it also provides other products or services, such Co-Marketing Partner shall not price, discount or otherwise offer (including bundling) the Licensed Product in any way that benefits such other products or services at the expense of such Licensed Product or otherwise disadvantage the Licensed Products. In all events, Alcon and its Affiliates and Marketing Partners and NovaCal’s Co-Marketing Partners shall price and offer Licensed Products sold by it hereunder in a manner consistent with standard practices in the pharmaceutical industry.

ARTICLE 8

PAYMENTS

8.1 Technology Access Fee . Within ten (10) business days after the Effective Date, Alcon shall pay to NovaCal a technology access fee of [***], of which: Ten Million Dollars ($10,000,000) is attributable for the rights granted to Alcon hereunder in the Ophthalmic Sub-Field,

 

[***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission.

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[***] is attributable for the rights granted to Alcon hereunder in the Otic Sub-Field, and [***] is attributable for the rights granted to Alcon hereunder in the Sinus Sub-Field. Such technology access fee shall be non-refundable, and shall not be creditable (except as otherwise provided in Section 12.5.2) against any other amount due hereunder.

8.2 Alcon Funding .

8.2.1 FTE Funding .

(a) Alcon agrees to fund during each year of the Funding Term, the number of NovaCal FTEs specified in the Discovery Research Plan and Development Plans, but no less than the number of NovaCal FTEs set forth in Exhibit 8.2 during the applicable calendar year under the Discovery Research Program and the Development Programs collectively. Effective beginning with the calendar year 2007, the FTE Rate shall increase no more than once annually on January 1 of each year by the percentage increase, if any, in (A) salaries as reported for the current fiscal year by Radford Surveys™ Quarterly Salary Increase Trend Survey (QSIT)—Biotechnology Edition Base Salary Increase Analysis for Exempt Employees (Current Fiscal Year Actual (Undiluted) Overall Increases Combined), or (B) the Consumer Price Index, for All Urban Consumers for the San Francisco Bay Area, as published by the U.S. Department of Labor, Bureau of Labor Statistics, in each case whichever increase is higher since the last such increase under this Section 8.2.1(a) (or in the case of the first such increase, the Effective Date) and such increase shall be effective on a going-forward basis for the then-current and all subsequent Discovery Research Plans and Development Plans hereunder until further modified under this Section 8.2.1(a). Notwithstanding anything herein to the contrary, NovaCal shall not have any obligation to perform any activities under the Discovery Research Plan or any Development Plan or incur any expenses with respect thereto if such activities are not funded by Alcon under this Section 8.2 or are to be performed after the expiration of the Funding Term.

(b) During January and July of each calendar year during the Funding Term, Alcon shall pay to NovaCal an amount equal to one-half of the product of the FTE Rate times the number of NovaCal FTEs specified in the then-current Discovery Research Plan and Development Plans. Unless otherwise specified in the Discovery Research Plan or a Development Plan, FTE numbers budgeted for the full year will be deemed budgeted in equal amounts for each calendar quarter during such year. Notwithstanding the foregoing, Alcon shall pay within ten (10) days of the Effective Date a prorated amount for the period from the Effective Date until December 31, 2006. In addition, the last calendar quarter during the Funding Term shall be appropriately prorated.

 

[***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission.

 

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8.2.2 Non-FTE Costs . If the Discovery Research Plan or Development Plan includes, and NovaCal agrees, that NovaCal conduct and fund any activity using Third Party resources or acquire any capital equipment, Alcon shall reimburse NovaCal for the actual amounts paid by NovaCal for such Third Party activities or capital equipment subject to production of receipts or other evidence of payment, all as pre-approved by Alcon.

8.2.3 Funding Term Extension . Alcon may extend the Funding Term for up to two (2) additional one (1)-year periods beyond the fourth (4 th ) anniversary of the Effective Date (each, a “ Funding Term Extension ”) by providing written notice to NovaCal at least six (6) months prior to the end of the then-current Funding Term. In the event that Alcon so elects to extend the Funding Term, Alcon’s obligation to provide FTE and other funding pursuant to this Section 8.2 shall apply to each such Funding Term Extension, unless otherwise agreed by the Parties.

8.3 Development Milestone Payments . Subject to Sections 8.3.1 and 8.3.2 below, Alcon shall pay to NovaCal the amounts set forth in the following table (each, a “ Milestone Payment ”) upon the first achievement of the corresponding milestone event for a Licensed Product intended for the prevention or treatment of any infection (each, a “ Milestone Event ”):

 

Milestone Event

  

Ophthalmic Sub-Field Milestone
Payment

   Otic Sub-Field Milestone
Payment
  

Sinus Sub-Field

Milestone Payment

1.  Non-rejection of an IND for an indication in the applicable Sub-Field

   [***]    [***]    [***]

2.  First initiation of a Phase III clinical trial for an indication in the applicable Sub-Field

   [***]    [***]    [***]

3.  First filing of an MAA in the United States for an indication in the applicable Sub-Field

   [***]    [***]    [***]

4.  First receipt of a Marketing Approval in the United States for an indication in the applicable Sub-Field

   [***]    [***]    [***]

 

[***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission.

 

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8.3.1 Certain Terms .

(a) If a Licensed Product intended for the treatment or prevention of any infection first achieves a milestone substantially equivalent to a Milestone Event with respect to a particular Sub-Field in a jurisdiction other than the United States prior to meeting such Milestone Event in the United States, then Alcon shall pay to NovaCal an amount equal to [***] of the applicable Milestone Payment for such Sub-Field. This Section 8.3.1(a) shall not limit in any way Alcon’s obligation to pay the Milestone Payment for such Milestone Event upon the achievement thereof in the United States; provided that, in such event, the amounts received by NovaCal under this Section 8.3.1(a) with respect to such Milestone Event outside of the United States will be creditable against the full Milestone Payment amount due upon the first achievement of such Milestone Event in the United States.

(b) For purposes of this Section 8.3:

(i) “ Non-rejection ” with respect to an IND shall be deemed to occur upon expiration of the period when the applicable Regulatory Authority may reject the IND or acceptance by the applicable Regulatory Authority thereof.

(ii) The “ initiation ” of a clinical trial shall be deemed to occur upon the first dosing of the first subject in such trial.

(c) It is understood that the Milestone Payments reflected under any column in the table above shall be payable whether or not Milestone Events have been paid for such Licensed Product with respect to other columns in such table.

(d) If a subsequent Milestone Event is achieved before a prior Milestone Event (“ prior ” and “ subsequent ” referring to a lower or higher, respectively, number corresponding to such milestone in the tables above, for e.g., Milestone Event 2 is “ prior ” to Milestone Event 3), then all such prior Milestone Events shall be deemed achieved upon achievement of the subsequent Milestone Event and become payable (if not previously paid) in accordance with this Section 8.3.

(e) Upon payment of the Milestone Payment for achievement of Milestone Event 4 with respect to a particular Sub-Field, Alcon shall have the right to credit [***] of such Milestone Payment against the royalties payable to NovaCal on Net Sales of Licensed Products in such Sub-Field recognized on or after twelve (12) months from the commercial launch of such Licensed Product in such Sub-Field in the United States, provided that no single royalty payment with respect to Licensed Products in such Sub-Field due to NovaCal hereunder may be reduced by more than [***].

 

[***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission.

 

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(f) With respect to each Sub-Field, in the event that Milestone Event 1 is not achieved by a Licensed Product for an indication in such Sub-Field prior to the [***] of the Effective Date, unless such failure to achieve Milestone Event 1 is attributable to NovaCal, Alcon shall pay to NovaCal [***] of the Milestone Payment for Milestone Event 1 for such Sub-Field, with the remaining [***] of such payment to be payable upon the achievement of Milestone Event 1 by a Licensed Product for an indication in such Sub-Field.

(g) With respect to each Sub-Field, in the event that Milestone Event 2 is not achieved by a Licensed Product for an indication in such Sub-Field prior to the [***] of the date on which Milestone Event 1 was first achieved with respect to such Sub-Field, Alcon shall pay to NovaCal [***] of the Milestone Payment for Milestone Event 2 for such Sub-Field, with the remaining [***] of such payment to be payable upon the achievement of Milestone Event 2 by a Licensed Product for an indication in such Sub-Field; provided, however if (i) the FDA requires long-term chronic preclinical or clinical studies for such Sub-Field, (ii) the FDA requires carcinogenicity studies prior to the initiation of a Phase III clinical trial for such Sub-Field, or (iii) Development Compound raw material from a validated manufacturing process is not available to support a Phase III clinical trial for such Sub-Field for reasons outside of Alcon’s reasonable control, then [***] of such Milestone Payment shall be payable until the achievement of Milestone Event 2 by a Licensed Product for an indication in the Sub-Field.

8.3.2 Milestone Payment Timing . The payments set forth in this Section 8.3 shall each be due and payable to NovaCal within thirty (30) days of the achievement (or deemed achievement) of the corresponding Milestone Event set forth above. Alcon agrees to promptly notify NovaCal of its achievement of each Milestone Event.

8.4 Royalty Payments . Alcon shall pay to NovaCal a royalty on Net Sales for each Licensed Product on a Sub-Field-by-Sub-Field basis, as follows:

8.4.1 Ophthalmic Sub-Field . With respect to Net Sales of Licensed Products labeled for applications in the Ophthalmic Sub-Field, Alcon shall pay to NovaCal a royalty equal to: (i) [***] of Net Sales of such Licensed Product for sales in each country within the Territory where such Licensed Product is Covered by a Valid Claim of a NovaCal Patent; and (ii)  [***] of Net Sales of such Licensed Product for sales in each country where such Licensed Product is not Covered by a Valid Claim of a NovaCal Patent.

8.4.2 Otic Sub-Field . With respect to Net Sales of Licensed Products labeled for applications in the Otic Sub-Field, Alcon shall pay to NovaCal a royalty equal to: (i) [***] of Net Sales of such Licensed Product for sales in each country within the Territory where such Licensed Product is Covered by a Valid Claim of a NovaCal Patent; and (ii)  [***] of Net Sales for such Licensed Product for sales in each country where such Licensed Product is not Covered by a Valid Claim of a NovaCal Patent.

 

[***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission.

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8.4.3 Sinus Sub-Field . With respect to Net Sales of Licensed Products labeled for applications in the Sinus Sub-Field, Alcon shall pay to NovaCal a royalty equal to: (i) [***] of Net Sales of such Licensed Product for sales in each country within the Territory where such Licensed Product is Covered by a Valid Claim of a NovaCal Patent; and (ii) [***] of Net Sales of such Licensed Product for sales in each country where such Licensed Product is not Covered by a Valid Claim of a NovaCal Patent.

8.4.4 Certain Terms .

(a) Notwithstanding the foregoing, if a Licensed Product is labeled for applications in multiple Sub-Fields or otherwise subject to multiple royalty rates hereunder only one royalty shall be due at the applicable highest royalty rate.

(b) “ Cover ” shall mean, with respect to any subject matter, the manufacture, use, sale, offering for sale, importation, exportation or other exploitation of such subject matter would infringe a claim of a NovaCal Patent at the time thereof. For clarity with respect to a claim within a patent application, “ Cover ” includes infringing a claim in such patent application if it were to issue as prosecuted in good faith. “ Covered ” or “ Covering ” have their correlative meanings.

8.4.5 Term of Royalties . NovaCal’s right to receive royalties under this Section 8.4 above shall expire on a Licensed Product-by-Licensed Product, Sub-Field-by-Sub-Field and country-by-country basis as follows:

(a) With respect to each of the United States, Japan, and any country within the European Union, upon the later to occur of (i) ten (10) years from the first commercial sale of such Licensed Product for applications in such Sub-Field in such country, and (ii) expiration of the last to expire Patent within the NovaCal Patents Covering such Licensed Product in such country.

(b) With respect to each of all other countries in the Territory, upon the later to occur of (i) ten (10) years from the first commercial sale of such Licensed Product for applications in such Sub-Field in the United States, and (ii) expiration of the last to expire Patent within the NovaCal Patents Covering such Licensed Product in such country.

 

[***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission.

 

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8.4.6 Payment/Reports . All payments under this Section 8.4 shall be due and payable within seventy-five (75) days of the last day of the calendar quarter during which the corresponding Net Sales are recognized. Together with any such payment, Alcon shall deliver a report specifying on a Licensed Product-by-Licensed Product, Sub-Field-by-Sub-Field basis: (i) total invoiced amount from sales of Licensed Products by Alcon and its Affiliates and Marketing Partners; (ii) Net Sales and (iii) total royalties payable. Notwithstanding the foregoing, if NovaCal is required by laws, rules or regulations applicable to NovaCal to report revenue or other information prior to or within fifteen (15) days of the date the reports to be provided by Alcon pursuant to this Section 8.4.6 are due, then Alcon shall cooperate in good faith with NovaCal to provide such information to permit NovaCal to comply with such laws, rules or regulations on a timely basis.

8.4.7 Competition . With respect to a given Licensed Product sold by Alcon or its Affiliates or Marketing Partners in any Sub-Field in any country, in the event that Alcon or its Affiliates or Marketing Partners experiences competition from a Third Party selling a product containing an Aganocide Compound (a “ Competing Product ”) and if either of the conditions below exists, then Alcon and NovaCal shall negotiate in good faith a new royalty rate, if any, for the involved country:

(a) Both NovaCal and Alcon conclude that enforcement of relevant NovaCal Patents against the Competing Product is precluded by reason of invalidity or costs; or

(b) There are no NovaCal Patents Covering the Competing Product in the applicable country.

8.5 Payment Method . All payments due under this Agreement to NovaCal shall be made by bank wire transfer in immediately available funds to an account designated by NovaCal. All payments hereunder shall be made in the legal currency of the United States of America, and all references to “$” or “Dollars” shall refer to United States dollars (i.e., the legal currency of the United States). Except as otherwise provided herein, all payments due to a Party hereunder shall be due and payable within thirty (30) days of an invoice from the other Party.

8.6 Taxes . Subject to Section 13.2, it is understood that each Party hereto is a United States entity and that all payments from one Party to the other required under this Agreement shall be made from and to a United States entity to the name or account at its designated United States address and accordingly no withholding taxes shall apply thereto.

8.7 Records . Alcon shall keep, and shall cause its Affiliates and Marketing Partners to keep, proper books of records and accounts in which full, true and correct entries (in conformity with GAAP), which shall be made for the purpose of determining the amounts payable or owed to NovaCal under this Agreement, and compliance with the other terms and conditions of this Agreement. Such books and records shall be maintained for a period of three (3) years following the end of the calendar year to which they pertain and kept reasonably accessible, and shall be made available for inspection, upon thirty (30) days written notice and not more than once in each calendar year, throughout such three (3) year period by an independent Third Party auditor selected by or

 

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under authority of NovaCal for such purposes, in accordance with Section 8.8 below. Once an inspection of a given calendar year is complete and any related issues resolved between the Parties, such calendar year will be closed for audit and shall not be subject to further inspection pursuant to this Section 8.7.

8.8 Inspection of Records . Alcon shall, and shall cause each of its respective Affiliates or Marketing Partners to permit, independent certified auditors to visit and inspect, during regular business hours and under the guidance of officers of the entity being inspected, and to examine the books or records and accounts of Alcon or such Affiliate or Marketing Partner to the extent relating to this Agreement and discuss the affairs, finances and accounts of Alcon or such Affiliate or Marketing Partner to the extent relating to this Agreement. Alcon or such Affiliate or Marketing Partner shall permit the independent certified public accountant (subject to obligations of confidentiality to Alcon or such Affiliate or Marketing Partner), appointed by NovaCal and reasonably acceptable to Alcon or such Affiliate or Marketing Partner, to inspect the books and records described in Section 8.7; provided that such inspection shall not occur more often than once per calendar year, unless a material error is discovered in such inspection, in which case NovaCal shall have the right to conduct an additional audit for such period. Any inspection conducted under this Section 8.8 shall be at the expense of NovaCal, unless such inspection reveals any underpayment of any amount due to NovaCal hereunder by at least ten percent (10%) for any period, in which case the full costs of such inspection shall be borne by Alcon. Any underpayment shall be paid by Alcon to NovaCal within fifteen (15) business days with interest on the underpayment at the rate specified in Section 8.9 from the date such payment was originally due.

8.9 Late Payment . Any payments or portions thereof due hereunder which are not paid when due shall bear interest, to the extent permitted by applicable law, from the date due until paid at a rate equal to the (thirty) 30 day London Inter-Bank Offering Rate (LIBOR) U.S. Dollars, as quoted in The Wall Street Journal (Eastern Edition) effective for the date on which the payment was due, plus an additional two percent (2%). This Section 8.9 shall in no way limit any other remedies available to either Party.

8.10 Currency Conversion . All amounts under this Agreement shall be payable in United States Dollars. In those cases where the amount due in United States Dollars is calculated based upon one or more currencies other than United States Dollars, such amounts shall be converted to United States Dollars using methods that are in compliance with GAAP and consistent with the financial statements of the Party making the payment.

ARTICLE 9

INTELLECTUAL PROPERTY

9.1 Ownership of Inventions .

9.1.1 General . As between the Parties, title to all inventions and other intellectual property made (i) solely by Alcon personnel in connection with this Agreement shall be owned by Alcon, (ii) solely by NovaCal personnel in connection with this Agreement shall be owned by

 

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NovaCal and (iii) made jointly by personnel of Alcon and NovaCal (such joint inventorship to be determined based upon U.S. patent law) in connection with this Agreement shall be jointly owned by Alcon and NovaCal. Except as expressly provided in this Agreement, it is understood that neither Party shall have any obligation to account to the other for profits, or to obtain any approval of the other Party to license, assign or otherwise exploit such jointly owned inventions or intellectual property, by reason of joint ownership thereof, and each Party hereby waives any right it may have under the laws of any jurisdiction to require any such approval or accounting .

9.1.2 Compound Improvements . Each Party agrees to promptly disclose to the other all Compound Improvements made by or under authority of such Party during the Exclusivity Period. Notwithstanding Section 9.1.1, as between the Parties, title to all Compound Improvements made by or under authority of a Party, whether alone or jointly with others, in connection with the activities conducted pursuant to this Agreement during the Exclusivity Period, shall be owned by, and are hereby assigned to, NovaCal. Otherwise, all other Compound Improvements shall be owned by Parties in accordance with Section 9.1.1. As used herein, “ Compound Improvement ” shall mean any invention or other subject matter comprising the composition of any Aganocide Compound (together with any and all intellectual property rights therein, including Patents).

9.2 Patent Prosecution .

9.2.1 NovaCal Patents . As between the Parties, NovaCal shall have the right, at its expense, to control the Prosecution and Maintenance of the NovaCal Patents using counsel of its choice. NovaCal agrees to: (i) keep Alcon reasonably informed with respect to such activities; and (ii) consult in good faith with Alcon regarding such matters, including the abandonment of any claims thereof covering the Licensed Products. If NovaCal determines to abandon any claims of a NovaCal Patent covering the Licensed Products in the Field anywhere in the Territory, then NovaCal shall provide Alcon with notice at least sixty (60) days or prior to the date such abandonment would become effective. In such event, Alcon shall have the right, at its option, to control the Prosecution and Maintenance of such claims at its own expense in NovaCal’s name. In the event Alcon elects to control the Prosecution and Maintenance of such claims, such claims shall not be considered Valid Claims for purposes of determining the applicable royalty rate under Section 8.4 above. For purposes of this Article 9, “ Prosecution and Maintenance ” shall mean, with respect to a Patent, the preparing, filing, prosecuting and maintenance of such Patent, as well as re-examinations, reissues, requests for Patent term extensions and the like with respect to such Patent, together with the conduct of interferences, the defense of oppositions and other similar proceedings with respect to the particular Patent; and “Prosecute and Maintain” shall have the correlative meaning.

9.2.2 Joint Patents . With respect to Patents claiming subject matter jointly owned by the Parties, the Parties shall Prosecute and Maintain such Patents solely as mutually agreed, on a case-by-case basis.

9.3 Defense of Third Party Infringement Claims . If any Licensed Product Manufactured, used or sold by Alcon or its Affiliates or Marketing Partners becomes the subject of a Third Party’s claim or assertion of infringement of a Patent relating to the manufacture, use, sale, offer for sale or

 

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importation of Licensed Product in the Field, the Party first having notice of the claim or assertion shall promptly notify the other Party, and the Parties shall promptly confer to consider the claim or assertion and the appropriate course of action. Unless the Parties otherwise agree in writing, each Party shall have the right to defend itself against a suit that names it as a defendant. Neither Party shall enter into any settlement of any claim described in this Section 9.3 that adversely affects the other Party’s rights or interests without such other Party’s written consent, which consent shall not be unreasonably conditioned, withheld or delayed. In any event, the Parties shall reasonably assist one another and cooperate in any such litigation at the other Party’s request and expense.

9.4 Enforcement . Subject to the provisions of this Section 9.4, in the event that Alcon reasonably believes that any NovaCal Patent is being infringed by a Third Party or is subject to a declaratory judgment action arising from such infringement, in each case with respect to the manufacture, use, sale, offer for sale or importation in the Territory of a product incorporating any Licensed Compound for any application within the Field (an “ Infringing Product ”), Alcon shall promptly notify NovaCal. In such event, NovaCal shall have the initial right (but not the obligation) to enforce such NovaCal Patents with respect to such infringement, or to defend any declaratory judgment action with respect thereto (for purposes of this Section 9.4, an “ Enforcement Action ”).

9.4.1 Initiating Enforcement Actions . In the event that NovaCal fails to initiate an Enforcement Action to enforce such NovaCal Patent against a commercially significant infringement by a Third Party in a country in the Territory, which infringement consists of the manufacture, use, sale, offer for sale or importation of an Infringing Product in the Field in such country, within ninety (90) days of a request by Alcon to initiate such Enforcement Action, Alcon may initiate an Enforcement Action against such infringement at its own expense. In such case, NovaCal shall cooperate with Alcon in such Enforcement Action at Alcon’s expense. The Party initiating or defending any such Enforcement Action shall keep the other Party reasonably informed of the progress of any such Enforcement Action, and such other Party shall have the right to participate with counsel of its own choice.

9.4.2 Recoveries . With respect to Enforcement Actions initiated by NovaCal in a country in the Territory, provided that Alcon agrees with such action (which agreement shall not be unreasonably withheld, delayed or conditioned), Alcon shall pay one half (1/2) of the costs and expenses (including attorneys’ and professional fees) incurred by NovaCal in such Enforcement Action. Any recovery received as a result of any Enforcement Action to enforce Patent Rights pursuant to this Section 9.4 shall be used first to reimburse the Parties for the costs and expenses (including attorneys’ and professional fees) incurred in connection with such Enforcement Action, and the remainder of the recovery shall be shared (to the extent the same represents damages from sales of Infringing Products within the Field in the Territory) equally between the Parties; provided, however, that if NovaCal initiates the Enforcement Action and Alcon does not pay one half (1/2) of the costs and expenses incurred by NovaCal therein, Alcon shall be entitled to only twenty-five percent (25%) of the net amount recovered in such Enforcement Action to the extent the same represents damages from sales of Infringing Products within the Field in the Territory; and if Alcon initiates the Enforcement Action at its own expense in accordance with this Section 9.4, any recovery received shall be used first to reimburse Alcon for the costs and expenses (including attorneys’ and

 

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professional fees) incurred in connection with such Enforcement Action, and the remainder of the recovery shall be shared as follows: Alcon shall be entitled to receive seventy-five percent (75%) of such damages and NovaCal shall retain twenty-five percent (25%) of such damages. It is understood that any recovery from an Enforcement Action, whether brought by NovaCal or Alcon, which do not represent damages from sales of Infringing Products within the Field in the Territory, shall inure solely and be paid over to NovaCal.

9.5 Third Party Technologies .

9.5.1 If after the Effective Date, NovaCal acquires or licenses from a Third Party subject matter within the NovaCal Technology (“ Third Party Technology ”) that is subject to payment obligations to the Third Party, then NovaCal shall so notify Alcon and the following shall apply, provided that the Third Party Technology represents additional technology that supplements the NovaCal Technology and is not intended primarily as a freedom-to-operate license or acquisition with respect to Commercialization of Licensed Compounds in the Field: the rights granted to Alcon hereunder with respect to such Third Party Technology shall be subject to Alcon promptly reimbursing NovaCal for the amounts that become owing to such Third Party by reason of the grant to or exercise by or under authority of Alcon of such rights to such Third Party Technology and Alcon shall reimburse NovaCal for a reasonable portion of any upfront fee or other similar amounts paid to acquire such Third Party Technology that is allocable to the rights granted to Alcon to such Third Party Technology hereunder. Upon request by Alcon, NovaCal shall disclose to Alcon a written description of such payment obligations. Alcon may exclude Third Party Technology from the rights granted to it hereunder by providing notice to NovaCal thereof, provided that such notice is provided prior to the exercise of any rights to such Third Party Technology by or under authority of Alcon; in such event, such Third Party Technology shall be deemed excluded from the NovaCal Patents, NovaCal Know-How and NovaCal Technology.

9.5.2 If after the Effective Date, Alcon or its Affiliates acquires or licenses from a Third Party any Know-How or Patents, required (i.e., for which there is no commercially practicable alternative) for the Development, Manufacture or Commercialization of Licensed Products (“ Alcon Technology ”), then Alcon shall use reasonable efforts to notify NovaCal thereof from time to time. If requested by NovaCal (whether as a result of such notice or otherwise), Alcon agrees, to the extent Alcon Controls rights outside the Field to such Alcon Technology to grant NovaCal a non-exclusive license, with the right to sublicense NovaCal’s Marketing Partners, to make, have made, use, sell, offer for sale and otherwise exploit such Alcon Technology in connection with activities with Licensed Compounds outside the Field, and the following shall apply: the rights granted to NovaCal hereunder with respect to such Alcon Technology shall be subject to NovaCal promptly reimbursing Alcon for the amounts that become owing to such Third Party by reason of the grant to or exercise by or under authority of NovaCal of such rights to such Alcon Technology and NovaCal shall reimburse Alcon for a reasonable portion of any upfront fee or other similar amounts paid to acquire such Third Party Technology that is allocable to the rights granted to NovaCal to such Alcon Technology hereunder, and all other terms under which Alcon acquired or licensed such Alcon Technology from such Third Party shall be passed through to NovaCal. Upon request by NovaCal, Alcon shall disclose to NovaCal a written description of such payment obligations. The Parties shall enter into a separate

 

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license agreement documenting such license grant and the associated terms and conditions; provided that NovaCal shall not have the right to exercise the licenses granted pursuant to this Section 9.5.2 with respect to Know-How or Patents in a manner that can reasonably be expected to (i) create a risk of substitutability of the type contemplated in Section 2.6.3 hereof, or (ii) otherwise compete with Alcon products in the ophthalmic, otic and nasal fields.

9.5.3 The obligations of NovaCal and the rights of Alcon under this Agreement shall be subject to, and limited by, any agreements pursuant to which NovaCal acquired or licensed any NovaCal Technology and if any such agreement requires that a particular provision be incorporated in a sublicense granted thereunder, such provision shall be deemed incorporated by reference herein only the extent so required and with respect to the subject matter of such agreement. Notwithstanding anything herein to the contrary, with respect to the Prosecution and Maintenance, and enforcement, of NovaCal Patents licensed by NovaCal from a Third Party, to the extent NovaCal has the right to do so, NovaCal shall cooperate with Alcon to Prosecute and Maintain and enforce such NovaCal Patents in the same manner as set forth in Sections 9.2 and 9.4 above. As between NovaCal and Alcon, any recoveries from enforcement of such NovaCal Patents licensed from a Third Party (including any amounts that NovaCal receives from the Third Party licensor as a result of such enforcement) shall be shared in accordance with Section 9.4.2, after deducting from such recoveries any amounts owed to the Third Party licensor for such enforcement; provided that any Enforcement Actions initiated by the Third Party licensor shall be deemed initiated by NovaCal for purposes of Section 9.4.2 above, and the costs and expenses incurred by NovaCal in such Enforcement Action shall include the costs and expenses reimbursed or required to be reimbursed by NovaCal to the Third Party licensor in such Enforcement Action.

9.6 Patent Marking . Alcon shall mark (or caused to be marked) all Licensed Products marketed and sold hereunder with appropriate NovaCal Patent numbers or indicia at NovaCal’s request to the extent permitted by law, in those countries in which such notices impact recoveries of damages or remedies available with respect to infringements of Patents.

ARTICLE 10

CONFIDENTIALITY

10.1 Confidentiality; Exceptions . Except to the extent expressly authorized by this Agreement or otherwise agreed by the Parties in writing, the Parties agree that the receiving Party shall keep confidential and shall not publish or otherwise disclose or use for any purpose other than as provided for in this Agreement any confidential or proprietary information or materials furnished to it by the other Party pursuant to this Agreement (collectively, “ Confidential Information ”). Notwithstanding the foregoing, Confidential Information shall not be deemed to include information or materials to the extent that it can be established by written documentation by the receiving Party that such information or material:

10.1.1 was already known to or possessed by the receiving Party, other than under an obligation of confidentiality (except to the extent such obligation has expired or an exception is applicable under the relevant agreement pursuant to which such obligation was established), at the time of disclosure;

 

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10.1.2 was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party;

10.1.3 became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement;

10.1.4 was independently developed by the receiving Party as demonstrated by documented evidence prepared contemporaneously with such independent development; or

10.1.5 was disclosed to the receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to the disclosing Party not to disclose such information to others.

10.2 Authorized Use and Disclosure . Each Party may use and disclose Confidential Information of the other Party as follows: (i) under appropriate confidentiality provisions substantially equivalent to those in this Agreement, in connection with the performance of its obligations or exercise of rights granted to such Party in this Agreement; (ii) to the extent such disclosure is reasonably necessary in filing for, prosecuting or maintenance of Patents, copyrights and trademarks (including applications therefor) in accordance with this Agreement, complying with the terms of agreements with Third Parties, prosecuting or defending litigation, complying with applicable governmental regulations, filing for, conducting preclinical or clinical trials, obtaining and maintaining regulatory approvals (including Marketing Approvals), marketing Licensed Products, or otherwise required by applicable law or regulation, provided, however, that if a Party is required by law or regulation to make any such disclosure of the other Party’s Confidential Information it will, except where impracticable for necessary disclosures (for example, in the event of medical emergency), give reasonable advance notice to the other Party of such disclosure requirement and, except to the extent inappropriate in the case of patent applications, will use its reasonable efforts to secure confidential treatment of such Confidential Information required to be disclosed; (iii) in communication with existing and potential investors, consultants, advisors (including financial advisors, lawyers and accountants) and others on a need to know basis, in each case under appropriate confidentiality provisions substantially equivalent to those of this Agreement; or (iv) to the extent mutually agreed to by the Parties.

10.3 Publications . Each Party shall submit to the other Party any proposed publication or public disclosure containing clinical or scientific results for the Licensed Products in the Field at least thirty (30) days in advance of the proposed date of submission for publication, so as to allow that Party to review such proposed publication or disclosure. The reviewing Party will promptly review such proposed publication or disclosure and make any objections or comments that it may have thereto, and the Parties shall discuss the advantages and disadvantages of publishing or disclosing such results. If the Parties are unable to agree on whether to publish or disclose the same, subject to Section 10.4

 

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below, the matter shall be referred to the Coordination Committee for resolution. This Section 10.3 shall not be deemed to limit the Parties’ obligations under Section 10.1 above.

10.4 Publicity .

10.4.1 Confidential Terms . Each of the Parties agrees not to disclose to any Third Party the terms and conditions of this Agreement without the prior approval of the other Party, except to advisors (including financial advisors, attorneys and accountants), potential and existing investors, and others (including in the case of NovaCal, potential and actual licensees under the NovaCal Technology) on a need to know basis, in each case under circumstances that reasonably protect the confidentiality thereof, or to the extent necessary to comply with the terms of agreements with Third Parties, or to the extent required by applicable law or regulation, including securities laws. Notwithstanding the foregoing, the Parties agree upon a joint press release to announce the execution of this Agreement, which is attached hereto as Exhibit 10.4.1 ; thereafter, NovaCal and Alcon may each disclose to Third Parties the information contained in such press release without the need for further approval by the other.

10.4.2 Publicity Review . The Parties acknowledge the importance of supporting each other’s efforts to publicly disclose results and significant developments regarding Licensed Products in the Field and other activities in connection with this Agreement, beyond what may be strictly required by applicable law or regulation, and each Party may make such disclosures from time to time with the approval of the other Party, which approval shall not be unreasonably withheld, conditioned or delayed. Such disclosures may include achievement of significant events in the Development (including regulatory process and occurrence of Milestone Events) or Commercialization of Licensed Products in the Field hereunder or receipt of payments. When a Party (the “ Requesting Party ”) elects to make any such public disclosure under this Section 10.4.2, it will give the other Party (the “ Cooperating Party ”) reasonable notice to review and comment on such statement, it being understood that if the Cooperating Party does not notify the Requesting Party in writing within five (5) business day period or such shorter period if required by applicable law of any reasonable objections, as contemplated in this Section 10.4.2, such disclosure shall be deemed approved, and in any event the Cooperating Party shall work diligently and reasonably to agree on the text of any proposed disclosure in an expeditious manner. The principles to be observed in such disclosures shall be accuracy, compliance with applicable laws, rules, regulations and regulatory guidance documents, reasonable sensitivity to potential negative reactions of applicable Regulatory Authorities (including the FDA), the potential loss of competitive advantage by publishing confidential information regarding the status of development efforts and/or commercialization plans prematurely, and the need to keep investors and others informed regarding the Requesting Party’s business. Accordingly, the Cooperating Party shall not withhold, condition or delay its approval of a proposed disclosure that complies with such principles.

 

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ARTICLE 11

REPRESENTATIONS, WARRANTIES AND COVENANTS; INDEMNIFICATION

11.1 General Representations and Warranties . Each Party represents and warrants to the other that:

11.1.1 it is duly organized and validly existing under the laws of its state of incorporation or registration, and has full corporate or partnership power and authority to enter into this Agreement and to carry out the provisions hereof;

11.1.2 it is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder, and the person or persons executing this Agreement on its behalf has been duly authorized to do so by all requisite corporate or partnership action;

11.1.3 this Agreement is legally binding upon it and enforceable in accordance with its terms. The execution, delivery and performance of this Agreement by it does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any material law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it;

11.1.4 it has not granted, and shall not grant during the Term, any right to any Third Party which would conflict with the rights granted to the other Party hereunder; and

11.1.5 it is not aware of any action, suit or inquiry or investigation instituted by any person or governmental agency which questions or threatens the validity of this Agreement.

11.2 NovaCal’s Warranties . NovaCal represents and warrants that as of the Effective Date:

11.2.1 NovaCal owns all right, title and interest in and to all NovaCal Patents in existence as of the Effective Date;

11.2.2 NovaCal has not granted, and will not grant during the Term, rights to any Third Party under the NovaCal Technology that conflict with the rights granted to Alcon hereunder;

11.2.3 NovaCal has not received any written notice of any threatened claims or litigation seeking to invalidate or otherwise challenge the NovaCal Patents or NovaCal’s rights therein;

11.2.4 to its knowledge, the manufacture, use or sale of the Licensed Compounds within its Control as of the Effective Date do not infringe any Third Party Patent;

11.2.5 to its knowledge, none of the NovaCal Patents are subject to any pending re-examination, opposition, interference or litigation proceedings; and

 

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11.2.6 NovaCal has not entered into any agreements of the type identified in Section 9.5.3.

11.3 Disclaimer of Warranties . EXCEPT AS SET FORTH IN THIS ARTICLE 11, NOVACAL AND ALCON EXPRESSLY DISCLAIM ANY WARRANTIES OR CONDITIONS, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, WITH RESPECT TO THE SUBJECT MATTER OF THIS AGREEMENT (INCLUDING THE NOVALCAL TECHNOLOGY), INCLUDING ANY WARRANTY OF MERCHANTABILITY, NONINFRINGEMENT, OR FITNESS FOR A PARTICULAR PURPOSE, AND NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.

11.4 Indemnification .

11.4.1 Indemnification by NovaCal . NovaCal hereby agrees to defend, hold harmless and indemnify (collectively “ Indemnify ”) Alcon and its Affiliates, and its and their agents, directors, officers and employees (the “ Alcon Indemnitees ”) from and against any liability or expense (including without limitation reasonable legal expenses and attorneys’ fees) (collectively “ Losses ”) resulting from suits, claims, actions and demands, in each case brought by a Third Party (each, a “ Third-Party Claim ”) arising out of a breach of any of NovaCal’s representations and warranties under Sections 11.1 or 11.2. NovaCal’s obligation to Indemnify the Alcon Indemnitees pursuant to this Section 11.4 shall not apply to the extent that any such Losses (A) arise from the gross negligence or intentional misconduct of any Alcon Indemnitee; (B) arise from any breach by Alcon of this Agreement; or (C) are Losses for which Alcon is obligated to Indemnify the NovaCal Indemnitees pursuant to Section 11.4.2.

11.4.2 Indemnification by Alcon . Alcon hereby agrees to Indemnify NovaCal and its Affiliates, and its and their agents, directors, officers and employees (the “ NovaCal Indemnitees ”) from and against any and all Losses resulting from Third-Party Claims arising out of: (i) a breach of any of Alcon’s representations and warranties under Section 11.1; or (ii) the Development, Manufacture, Commercialization, storage, handling, use, sale, offer for sale or importation of Development Compounds and/or Licensed Products or other exercise of the licenses granted hereunder by or under authority of Alcon. Alcon’s obligation to Indemnify the NovaCal Indemnitees pursuant to the foregoing sentence shall not apply to the extent that any such Losses (A) arise from the gross negligence or intentional misconduct of any NovaCal Indemnitee; (B) arise from any breach by NovaCal of this Agreement; (C) are Losses for which NovaCal is obligated to Indemnify the Alcon Indemnitees pursuant to Section 11.4.1; or (D) result from a finding that the manufacture or sale of a Development Compound or the use thereof in the Field infringes the patent rights of a Third Party.

11.4.3 Procedure . To be eligible to be Indemnified hereunder, the indemnified Party shall provide the indemnifying Party with prompt notice of the Third-Party Claim giving rise to the indemnification obligation pursuant to this Section 11.4 and the exclusive ability to defend (with the reasonable cooperation of the indemnified Party) or settle any such claim; provided, however, that the indemnifying Party shall not enter into any settlement that admits fault, wrongdoing or damages

 

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without the indemnified Party’s written consent, such consent not to be unreasonably withheld or delayed. The indemnified Party shall have the right to participate, at its own expense and with counsel of its choice, in the defense of any claim or suit that has been assumed by the indemnifying Party.

11.5 Insurance . Alcon shall obtain and maintain, during the term of this Agreement and for six (6) years thereafter, $5 million combined single limit for comprehensive general liability insurance, including products liability insurance and coverage for clinical trials, with reputable and financially secure insurance carriers or captive insurer in a form and at levels consistent with industry standards based upon Alcon’s activities hereunder and indemnification obligations hereunder, with NovaCal named as an additional insured. NovaCal shall obtain and maintain, during the term of this Agreement and for a period of six (6) years thereafter, $5 million combined single limit for comprehensive general liability insurance, including coverage for clinical trials, with reputable and financially secure insurance carriers in a form and at levels consistent with industry standards based upon NovaCal’s activities hereunder and indemnification obligations hereunder, with Alcon named as an additional insured. Such liability insurance or self-insurance through a captive insurer shall be maintained on an occurrence basis to provide such protection after expiration or termination of the policy itself or this Agreement or claims made basis with purchased tail coverage for six (6) years. Each Party shall furnish to the other Party on request a certificate of insurance issued by the insurance company or captive insurer setting forth the amount of the liability insurance and a provision that the other Party hereto shall receive thirty (30) days’ written notice prior to termination or material reduction to the level of coverage.

ARTICLE 12

TERM AND TERMINATION

12.1 Term . This Agreement shall become effective as of the Effective Date and, unless earlier terminated pursuant to the other provisions of this Article 12, shall continue in full force and effect on a country-by-country and Licensed Product-by-Licensed Product basis until Alcon has no remaining royalty payment obligations in such country with respect to such Licensed Product (the “ Term ”).

12.2 Termination by Alcon .

12.2.1 Alcon shall have the right to terminate this Agreement in its entirety upon nine (9) months’ prior notice to NovaCal referencing this Section 12.2.1.

12.2.2 If the Coordination Committee determines that it is unlikely that any Licensed Product will (i) obtain Marketing Approval for an application in a particular Sub-Field in any Major Market, or (ii) be a commercial success in any Major Market in particular Sub-Field, then Alcon shall have the right to terminate this Agreement with respect to such Sub-Field upon one hundred thirty five (135) days’ prior notice to NovaCal referencing this Section 12.2.2. If the Coordination Committee determines that it is unlikely that any Licensed Product will (i) obtain Marketing Approval for an application in any particular Sub-Field in any Major Market, or (ii) be a commercial

 

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success in any Major Market in any Sub-Field, then Alcon shall have the right to terminate this Agreement in its entirety upon one hundred thirty five (135) days’ prior notice to NovaCal referencing this Section 12.2.2.

12.3 Termination for Breach . Either Party may terminate this Agreement in the event the other Party materially breaches this Agreement, and such breach shall have continued for sixty (60) days after notice thereof was provided to the breaching Party by the non-breaching Party. Any such termination shall become effective at the end of such sixty (60) day period unless the breaching Party has cured any such breach prior to the expiration of the sixty (60) day period.

12.4 General Effects of Expiration or Termination .

12.4.1 Accrued Obligations . Expiration or termination of this Agreement for any reason shall not release either Party from any obligation or liability which, at the time of such expiration or termination, has already accrued to the other Party or which is attributable to a period prior to such expiration or termination.

12.4.2 Non-Exclusive Remedy . Notwithstanding anything herein to the contrary, termination of this Agreement by a Party shall be without prejudice to other remedies such Party may have at law or equity.

12.4.3 General Survival . Articles 1, 10 and 13 and Sections 7.1.2(b), 7.1.4 (to the extent applicable to Section 7.1.2(b)), 8.4.6 (with respect to activities prior to the effective date of such termination or expiration or otherwise conducted pursuant to this Article 12), 8.5, 8.6, 8.7 (for the period described therein), 8.8 (for the period described in Section 8.7), 8.9, 8.10, 9.1, 9.2.2, 9.4 (with respect to Enforcement Actions initiated prior to the effective date of such termination or expiration), 11.3, 11.4, 11.5 (for the period described therein), 12.4 and 12.5 shall survive expiration or termination of this Agreement for any reason. Except as otherwise provided in this Article 12, all rights and obligations of the Parties under this Agreement shall terminate upon expiration or termination of this Agreement for any reason.

12.5 Effects of Certain Terminations .

12.5.1 Termination of this Agreement Pursuant to Section 12.2 or 12.3 . If Alcon electively terminates this Agreement in its entirety pursuant to Section 12.2 or either Party terminates this Agreement pursuant to Section 12.3, then:

(a) Ongoing Trials . Provided that the termination of this Agreement is not a termination by Alcon pursuant to Section 12.3, if there are any ongoing clinical trials with respect to Licensed Products being conducted by or on behalf of Alcon (or its Affiliate or Marketing Partner) at the time of notice of termination, Alcon agrees, at NovaCal’s request, to (i) promptly transition to NovaCal or its designee some or all of such clinical trials and the activities related to or supporting such trials at Alcon’s expense, (ii) continue to conduct such clinical trials for a period requested by NovaCal up to a maximum of six (6) months after the effective date of such

 

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termination, for which NovaCal would reimburse Alcon for its out-of-pocket expenses incurred with respect thereto, or (iii) terminate such clinical trials; in each case as requested by NovaCal, but in no event shall Alcon be required to continue clinical trials if it reasonably believes such continuation might adversely affect the health of patients participating in the clinical study.

(b) Commercialization . Provided that the termination of this Agreement is not a termination by Alcon pursuant to Section 12.3, if requested by NovaCal, Alcon and its Affiliates and Marketing Partners shall continue to distribute and sell Licensed Products in each country of the Territory for which Marketing Approval therefor has been obtained, in accordance with the terms and conditions of this Agreement, for a period requested by NovaCal not to exceed two (2) years from the effective date of such expiration or termination (for purposes of this Section 12.5.1, the “ Agreement Wind-Down Period ”); provided that NovaCal may terminate the Agreement Wind-Down Period upon sixty (60) days’ notice to Alcon. Notwithstanding any other provision of this Agreement, during the Agreement Wind-Down Period, Alcon’s, its Affiliates’ and its Marketing Partners’ rights with respect to Licensed Products (including the licenses granted under Section 7.1) shall be non-exclusive, NovaCal’s obligations under Section 7.4 shall terminate, and NovaCal shall have the right to engage one or more other Alcon(s) or distributor(s) of Licensed Products in all or part of the Territory. Any Licensed Products sold or disposed by Alcon or its Affiliates or Marketing Partners during the Agreement Wind-Down Period shall be subject to royalties under Section 8.4 above. After the Agreement Wind-Down Period, Alcon and its Affiliates and Marketing Partners shall not make any representation regarding their status as a Licensee of or distributor for NovaCal for any Licensed Product.

(c) Regulatory Filings . Provided that the termination of this Agreement is not a termination by Alcon pursuant to Section 12.3, Alcon shall promptly assign and transfer to NovaCal all Regulatory Filings for Licensed Products that are held or controlled by or under authority of Alcon or its Affiliates or Marketing Partners, and shall take such actions and execute such other instruments, assignments and documents as may be necessary to effect the transfer of rights under the Regulatory Filings to NovaCal. Alcon shall cause each of its Marketing Partners to transfer any such Regulatory Filings to NovaCal if this Agreement terminates. If applicable law prevents or delays the transfer of ownership of a Regulatory Filing to NovaCal, Alcon shall grant to NovaCal a permanent, exclusive and irrevocable right of access and reference to such Regulatory Filing for Licensed Products, and shall cooperate fully to make the benefits of such Regulatory Filings available to NovaCal and/or its designee(s). Within sixty (60) days after notice of such termination, Alcon shall provide to NovaCal copies of all such Regulatory Filings, and of all preclinical and clinical data (including investigator reports, both preliminary and final, statistical analyses, expert opinions and reports, safety and other electronic databases) . NovaCal shall be free to use and disclose such Regulatory Filings and other items in connection with the license under Section 12.5.1(d) below.

(d) Technology Licenses . Alcon hereby grants NovaCal, effective upon the notice of termination under Section 12.2 or the effective date of such termination by NovaCal under Section 12.3, a non-exclusive, worldwide, irrevocable, license, under (i) any Patent Controlled by Alcon or its Affiliates covering Licensed Products for which any human clinical trial or other

 

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human testing had been initiated or that were being Commercialized by or under authority of Alcon; provided, however if any such Patent Controlled by Alcon is subject to payment obligations to a Third Party, Alcon shall promptly disclose such obligations to NovaCal in writing and such Patents shall be deemed to be Controlled by Alcon only if NovaCal agrees in writing to reimburse all amounts owed to such Third Party as a result of NovaCal’s exercise of such license, and (ii) any Know-How disclosed to NovaCal under this Agreement or developed or utilized by Alcon in connection with such Licensed Products; in each case to the extent necessary to make, have made, use, sell, offer for sale and import Licensed Compounds and such Licensed Products. For such license, NovaCal shall pay Alcon a royalty that shall not exceed [***] of net sales of such Licensed Compounds or Licensed Products covered by such Patents or incorporating such Know-How. Accordingly, within thirty (30) days of notice of termination under Section 12.2 or the effective date of such termination by NovaCal under Section 12.3, the Parties shall initiate good faith negotiations to define an appropriate license agreement.

(e) Trademarks . Provided that the termination of this Agreement is not a termination by Alcon pursuant to Section 12.3, Alcon shall consider assigning or causing to be assigned to NovaCal all worldwide rights in and to any trademarks specific to one or more Licensed Products that Alcon used with Licensed Product(s), such assignment to be conditioned on Alcon’s approval, such approval not be unreasonably withheld. Factors Alcon will take into account in determining whether to grant such approval shall include but not be limited to the similarity of the involved trademarks and trade dress rights to other trademarks and trade dress rights owned or used by Alcon. It is understood that such assignment shall not include the Alcon name or trademark for the Alcon company itself.

(f) Marketing Partners . Provided that the termination of this Agreement is not a termination by Alcon pursuant to Section 12.3, Alcon’s Marketing Partners of Licensed Products shall, at the request of NovaCal, be assigned to NovaCal to the furthest extent possible. In the event NovaCal does not request assignment of such Marketing Partners, then the rights of such Marketing Partners with respect to Licensed Products shall terminate upon termination of Alcon’s rights with respect to Licensed Products.

(g) Governance . Any activities undertaken by NovaCal or a Third Party designee with respect to the Licensed Products during the Agreement Wind-Down Period shall be subject to the authority of the Coordination Committee or any of the provisions of Article 2, 3, 4, 5 or 6 above.

(h) Transition Assistance . Provided that the termination of this Agreement is not a termination by Alcon pursuant to Section 12.3, Alcon agrees to fully cooperate

 

[***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission.

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with NovaCal and its designee(s) to facilitate a smooth, orderly and prompt transition of the Development and Commercialization of Licensed Products to NovaCal and/or its designee(s) during the Agreement Wind-Down Period. Without limiting the foregoing, Alcon shall promptly provide NovaCal copies of customer lists and other customer information relating to Licensed Products reasonably necessary in Alcon’s reasonable opinion for NovaCal to continue to market such Licensed Products, which NovaCal shall have the right to use and disclose for any purpose during the Agreement Wind-Down Period and thereafter. Upon request by NovaCal, Alcon shall transfer to NovaCal some or all quantities of Licensed Products in its or its Affiliates’ possession (as requested by NovaCal), within thirty (30) days after the end of the Agreement Wind-Down Period; provided, however, that NovaCal shall reimburse Alcon for the out-of-pocket costs that Alcon actually incurred to Manufacture or otherwise acquire the quantities so provided to NovaCal. If any Licensed Product was Manufactured by any Third Party for Alcon, or Alcon had contracts with vendors which contracts are necessary or useful for NovaCal to take over responsibility for the Licensed Products in the Territory, then Alcon shall to the extent possible and requested in writing by NovaCal, assign all of the relevant Third-Party contracts to NovaCal, and in any case, Alcon agrees to cooperate with NovaCal to ensure uninterrupted supply of Licensed Products. If Alcon or its Affiliate Manufactured any Licensed Product at the time of termination, then Alcon (or its Affiliate) shall continue to provide for Manufacturing of such Licensed Product for NovaCal, at the rate set forth in Section 6.1.4, from the date of notice of such termination until such time as NovaCal is able, using Commercially Reasonable Efforts to do so, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities of Licensed Product may be procured and legally sold in the Territory, but in no event later than the expiration of the Agreement Wind-Down Period.

(i) Return of Materials . Except to the extent it has the right to use such Confidential Information in accordance with the express terms hereof, within forty-five (45) days after the end of the Agreement Wind-Down Period, each Party shall destroy all tangible items comprising, bearing or containing any Confidential Information of the other Party that are in its or its Affiliates’ possession or control, and provide written certification of such destruction, or prepare such tangible items of Confidential Information for shipment to such other Party, as such other Party may direct, at such other Party’s expense; provided that each Party may retain one (1) copy of such Confidential Information for its legal archives.

12.5.2 Termination with respect to a Sub-Field Pursuant to Section 12.2 . If Alcon electively terminates this Agreement with respect to a particular Sub-Field pursuant to Section 12.2, then:

(a) Ongoing Trials . If there are any ongoing clinical trials with respect to Licensed Products in such Sub-Field being conducted by or on behalf of Alcon (or its Affiliate or Marketing Partner) at the time of notice of termination, Alcon agrees, at NovaCal’s request, to (i) promptly transition to NovaCal or its designee some or all of such clinical trials and the activities related to or supporting such trials at Alcon’s expense, (ii) continue to conduct such clinical trials for a period requested by NovaCal up to a maximum of six (6) months after the effective date of such termination, for which NovaCal would reimburse Alcon for its out-of-pocket expenses incurred with

 

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respect thereto, or (iii) terminate such clinical trials; in each case as requested by NovaCal, but in no event shall Alcon be required to continue clinical trials if it reasonably believes such continuation might adversely affect the health of the patients participating in the study.

(b) Commercialization . If requested by NovaCal, Alcon and its Affiliates and Marketing Partners shall continue to distribute and sell Licensed Products in such Sub-Field in each country of the Territory for which Marketing Approval therefor has been obtained, in accordance with the terms and conditions of this Agreement, for a period requested by NovaCal not to exceed two (2) years from the effective date of such expiration or termination (for purposes of this Section 12.5.2, the “ Sub-Field Wind-Down Period ”); provided that NovaCal may terminate the Sub-Field Wind-Down Period upon sixty (60) days’ notice to Alcon. Notwithstanding any other provision of this Agreement, during the Sub-Field Wind-Down Period, Alcon’s, its Affiliates’ and its Marketing Partners’ rights with respect to Licensed Products in such Sub-Field (including the licenses granted under Section 7.1) shall be non-exclusive, NovaCal’s obligations under Section 7.4 shall terminate with respect to such Sub-Field , and NovaCal shall have the right to engage one or more other Alcon(s) or distributor(s) of Licensed Products in such Sub-Field in all or part of the Territory. Any Licensed Products in such Sub-Field sold or disposed by Alcon or its Affiliates or Marketing Partners during the Sub-Field Wind-Down Period shall be subject to royalties under Section 8.4 above. After the Sub-Field Wind-Down Period, Alcon and its Affiliates and Marketing Partners shall not make any representation regarding their status as a Licensee of or distributor for NovaCal for any Licensed Product in such Sub-Field .

(c) Regulatory Filings . Alcon shall promptly assign and transfer to NovaCal all Regulatory Filings for Licensed Products in such Sub-Field that are held or controlled by or under authority of Alcon or its Affiliates or Marketing Partners, and shall take such actions and execute such other instruments, assignments and documents as may be necessary to effect the transfer of rights under the Regulatory Filings to NovaCal. Alcon shall cause each of its Marketing Partners to transfer any such Regulatory Filings to NovaCal if this Agreement terminates. If applicable law prevents or delays the transfer of ownership of a Regulatory Filing to NovaCal, Alcon shall grant to NovaCal a permanent, exclusive and irrevocable right of access and reference to such Regulatory Filing for Licensed Products in such Sub-Field, and shall cooperate fully to make the benefits of such Regulatory Filings available to NovaCal and/or its designee(s). Within sixty (60) days after notice of such termination, Alcon shall provide to NovaCal copies of all such Regulatory Filings, and of all preclinical and clinical data (including investigator reports, both preliminary and final, statistical analyses, expert opinions and reports, safety and other electronic databases) and other Know-How information pertaining to any Licensed Compounds, Development Compound or Licensed Product, or the manufacture thereof, in each case with respect to such Sub-Field. NovaCal shall be free to use and disclose such Regulatory Filings and other items in connection with the license under Section 12.5.2(d) below.

(d) Technology Licenses . Alcon hereby grants NovaCal, effective upon the notice of such termination, a non-exclusive, worldwide, license, under (i) any Patent Controlled by Alcon or its Affiliates covering Licensed Products for which any human clinical trial or other human testing had been initiated or that were being Commercialized by or under authority of Alcon

 

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at the time of such termination and (ii) any Know-How disclosed to NovaCal under this Agreement or developed or utilized by Alcon in connection with such Licensed Products; in each case to make, have made, use, sell, offer for sale and import such Licensed Products in such Sub-Field. For such license, NovaCal shall pay Alcon a royalty that shall not exceed [***] of net sales of such Licensed Compounds or Licensed Products covered by such Patents or incorporating such Know-How. Accordingly, within thirty (30) days of notice of termination under Section 12.2, the Parties shall initiate good faith negotiations to define an appropriate license agreement. Notwithstanding the foregoing, NovaCal shall not have the right to exercise the licenses granted pursuant to this Section 12.5.2(d) with respect to Know-How and Patents in a manner that can reasonably be expected to (i) create a risk of substitutability of the type contemplated in Section 2.6.3 hereof, or (ii) otherwise compete with Alcon products in the ophthalmic, otic and nasal fields, other than in the terminated Sub-Field.

(e) Trademarks . Alcon hereby assigns and shall cause to be assigned to NovaCal all worldwide rights in and to any trademarks or trade dress specific to one or more Licensed Products in such Sub-Field that Alcon used with such Licensed Product(s) if such trademarks or trade dress are not used by Alcon or its Affiliates or Marketing Partners with Licensed Products in other Sub-Fields or, in Alcon’s reasonable opinion, are not too similar to trademarks or trade dress used by Alcon for other products in any Sub-Field. It is understood that such assignment shall not include the Alcon name or trademark for the Alcon company itself.

(f) Marketing Partners . Alcon’s Marketing Partners of Licensed Products in such Sub-Field shall, at the request of NovaCal, be assigned to NovaCal to the furthest extent possible. In the event NovaCal does not request assignment of such Marketing Partners, then the rights of such Marketing Partners with respect to Licensed Products in such Sub-Field shall terminate upon termination of Alcon’s rights with respect to such Licensed Products.

(g) Governance . Any activities undertaken by NovaCal or a Third Party designee with respect to the Licensed Products in such Sub-Field during the Sub-Field Wind-Down Period shall be subject to the authority of the Coordination Committee or any of the provisions of Article 2, 3, 4, 5 or 6 above.

(h) Transition Assistance . Alcon agrees to fully cooperate with NovaCal and its designee(s) to facilitate a smooth, orderly and prompt transition of the Development and Commercialization of Licensed Products in such Sub-Field to NovaCal and/or its designee(s) during the Sub-Field Wind-Down Period. Without limiting the foregoing, Alcon shall promptly provide NovaCal copies of customer lists and other customer information relating to such Licensed Products reasonably necessary in Alcon’s reasonable opinion for NovaCal to continue to market such

 

[***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission.

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Licensed Products in such Sub-Field, which NovaCal shall have the right to use and disclose for any purpose related to such Sub-Field during the Sub-Field Wind-Down Period and thereafter. Upon request by NovaCal, Alcon shall transfer to NovaCal some or all quantities of Licensed Products in such Sub-Field in its or its Affiliates’ possession (as requested by NovaCal), within thirty (30) days after the end of the Sub-Field Wind-Down Period; provided, however, that NovaCal shall reimburse Alcon for the out-of-pocket costs that Alcon actually incurred to Manufacture or otherwise acquire the quantities so provided to NovaCal. If any Licensed Product in such Sub-Field was Manufactured by any Third Party for Alcon, or Alcon had contracts with vendors which contracts are necessary or useful for NovaCal to take over responsibility for such Licensed Products in the Territory, then Alcon shall to the extent possible and requested in writing by NovaCal, assign all of the relevant Third-Party contracts to NovaCal, and in any case, Alcon agrees to cooperate with NovaCal to ensure uninterrupted supply of such Licensed Products. If Alcon or its Affiliate Manufactured any Licensed Product in such Sub-Field at the time of termination, then Alcon (or its Affiliate) shall continue to provide for Manufacturing of such Licensed Product for NovaCal, at the rate set forth in Section 6.1.4, from the date of notice of such termination until such time as NovaCal is able, using Commercially Reasonable Efforts to do so, to secure an acceptable alternative commercial manufacturing source from which sufficient quantities of such Licensed Product may be procured and legally sold in the Territory.

(i) Return of Materials . Except to the extent it has the right to use such Confidential Information in accordance with the express terms hereof, within forty-five (45) days after the end of the Sub-Field Wind-Down Period, each Party shall destroy all tangible items comprising, bearing or containing any Confidential Information of the other Party relating to such Sub-Field that are in its or its Affiliates’ possession or control, and provide written certification of such destruction, or prepare such tangible items of Confidential Information for shipment to such other Party, as such other Party may direct, at such other Party’s expense; provided that each Party may retain one (1) copy of such Confidential Information for its legal archives.

(j) Credit to Alcon . In the event Alcon terminates this Agreement with respect to a particular Sub-Field pursuant to Section 12.2 , Alcon shall have the right to credit [***] of the technology access fee paid to NovaCal under Section 8.1 attributable to such Sub-Field (e.g., if Alcon terminates its rights with respect to the Otic Sub-Field, then [***] would be creditable under this provision) against (i) Milestone Payments payable to NovaCal under Section 8.3 upon achievement of Milestone Events 3 and 4, and (ii) royalty payments payable to NovaCal under Section 8.4 on Net Sales of Licensed Products occurring after the effective date of such termination; provided, however, in no event will any payment due to NovaCal be so reduced by more than [***] and no amount of any portion of the technology access fee be refundable.

 

[***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission.

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12.6 Termination Press Releases . In the event of termination of this Agreement for any reason, the Parties shall cooperate in good faith to coordinate public disclosure of such termination and the reasons therefor, and shall not, except to the extent required by applicable law, disclose such information without the prior approval of the other Party, such approval not to be unreasonably withheld, conditioned or delayed. To the extent possible under the situation, the terminating Party shall provide the non-terminating Party with a draft of any such public disclosure it intends to issue five (5) business days in advance and with the opportunity to review and comment on such statement, it being understood that if the non-terminating Party does not notify the terminating Party in writing within such five (5) business day period (or such shorter period if required by applicable law and as notified to the non-terminating Party in writing) of any reasonable objections, such disclosure shall be deemed approved, and in any event the Parties shall work diligently and reasonably to agree on the text of any such proposed disclosure in an expeditious manner. The principles to be observed in such disclosures shall be accuracy, compliance with applicable law and regulatory guidance documents, reasonable sensitivity to potential negative reactions to such news and the need to keep investors and others informed regarding the Parties’ business and other activities. Accordingly in such situation, the non-terminating Party shall not withhold, condition or delay its approval of a proposed disclosure that complies with such principles.

ARTICLE 13

MISCELLANEOUS

13.1 Governing Law . This Agreement and any dispute arising from the performance or breach hereof shall be governed by and construed and enforced in accordance with the laws of the State of Delaware, without reference to conflicts of laws principles.

13.2 Assignment . This Agreement shall not be assignable by either Party to any Third Party without the written consent of the other Party and any such attempted assignment shall be void. Notwithstanding the foregoing, either Party may assign this Agreement, without the written consent of the other Party, to an entity that acquires all or substantially all of the business or assets of such Party to which this Agreement pertains (whether by merger, reorganization, acquisition, sale or otherwise), and agrees in writing to be bound by the terms and conditions of this Agreement. If any permitted assignment would result in withholding or other similar taxes becoming due on payments to the other Party under this Agreement, such payments shall be subject to such withholding tax laws, rules and regulations as may be applicable and, if such laws, rules or regulations require a withholding to be made from such payments, the payments net of withholding taxes shall constitute full compliance with this Agreement. No assignment or transfer of this Agreement to any Third Party shall be valid and effective unless and until the assignee/transferee agrees in writing to be bound by the provisions of this Agreement. The terms and conditions of this Agreement shall be binding on and inure to the benefit of the permitted successors and assigns of the Parties. Except as expressly provided in this Section 13.2, any attempted assignment or transfer of this Agreement to any Third Party shall be null and void.

13.3 Notices . Any notice, request, delivery, approval or consent required or permitted to be given under this Agreement shall be in writing and shall be deemed to have been sufficiently

 

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given if delivered in person, transmitted by facsimile (receipt verified) or by express courier service (signature required) or five (5) days after it was sent by registered letter, return receipt requested (or its equivalent), provided that no postal strike or other disruption is then in effect or comes into effect within two (2) days after such mailing, to the Party to which it is directed at its address or facsimile number shown below or such other address or facsimile number as such Party will have last given by notice to the other Party.

 

If to NovaCal, addressed to:

   NovaCal Pharmaceuticals, Inc.
   5980 Horton Street, Suite 550
   Emeryville, California 94608
  

Attention: President

   Telephone: (510) 595-1100
   Facsimile: (415) 329-2034

With a copy to:

   Wilson Sonsini Goodrich & Rosati
   Professional Corporation
   650 Page Mill Road
   Palo Alto, CA 94304-1050
   Attention: Ian B. Edvalson, Esq.
   Telephone: (650) 493-9300
   Facsimile: (650) 493-6811

If to Alcon, addressed to:

   Alcon Manufacturing, Ltd.
   6201 S. Freeway
   Fort Worth, TX 76134-2099
  

Attention:    Tom Capetan,

  

                       Sr. Director, Licensing/Business Development

   Telephone: (817) 551-8361
   Facsimile: (817) 568-7638

With a copy to:

   Alcon Research, Ltd.
   6201 S. Freeway, TB4-8
   Fort Worth, TX 76134-2099
  

Attention:    Gregg Brown,

  

                       Vice President, IP Legal

   Telephone: (817) 551-8663
   Facsimile:
   (817) 551-4610

13.4 Waiver . Neither Party may waive or release any of its rights or interests in this Agreement except in writing. The failure of either Party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition. No waiver by either Party of any condition or term in any one or more instances shall be construed as a continuing waiver of such condition or term or of another condition or term.

 

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13.5 Severability . If any provision hereof should be held invalid, illegal or unenforceable in any jurisdiction, the Parties shall negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the Parties and all other provisions hereof shall remain in full force and effect in such jurisdiction and shall be liberally construed in order to carry out the intentions of the Parties as nearly as may be possible. Such invalidity, illegality or unenforceability shall not affect the validity, legality or enforceability of such provision in any other jurisdiction. If a Party seeks to avoid a provision of this Agreement by asserting that such provision is invalid, illegal or otherwise unenforceable, the other Party shall have the right to terminate this Agreement upon sixty (60) days prior written notice to the asserting Party, unless such assertion is eliminated and cured within such sixty (60) day period. If such termination is by NovaCal, it shall be deemed a termination under Section 12.2, and if such termination is by Alcon, it shall be deemed a termination under Section 12.3 by reason of a breach by NovaCal.

13.6 Entire Agreement/Modification . This Agreement, including its Exhibits, sets forth all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties and supersedes and terminates all prior agreements and understandings between the Parties, except for that certain Material Transfer Agreement between NovaCal and Alcon Research, Ltd. effective as of July 1, 2005 (the “ MTA ”). Accordingly, it is understood and acknowledged that the MTA shall continue in full force in accordance with its terms. In the event of any conflict between the MTA and this Agreement, the provisions of this Agreement shall control. No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by the respective authorized officers of the Parties.

13.7 Relationship of the Parties . The Parties agree that the relationship of NovaCal and Alcon established by this Agreement is that of independent contractors. Furthermore, the Parties agree that this Agreement does not, is not intended to, and shall not be construed to, establish an employment, agency or any other relationship. Except as may be specifically provided herein, neither Party shall have any right, power or authority, nor shall they represent themselves as having any authority to assume, create or incur any expense, liability or obligation, express or implied, on behalf of the other Party, or otherwise act as an agent for the other Party for any purpose.

13.8 Force Majeure . Except with respect to payment of money, neither Party shall be liable to the other for failure or delay in the performance of any of its obligations under this Agreement for the time and to the extent such failure or delay is caused by earthquake, riot, civil commotion, war, terrorist acts, strike, flood, or governmental acts or restriction, or other cause that is beyond the reasonable control of the respective Party. The Party affected by such force majeure will provide the other Party with full particulars thereof as soon as it becomes aware of the same (including its best estimate of the likely extent and duration of the interference with its activities), and will use commercially reasonable efforts to overcome the difficulties created thereby and to resume performance of its obligations as soon as practicable. If the performance of any such obligation under this Agreement is delayed owing to such a force majeure for any continuous period of more than one hundred eighty (180) days, the Parties will consult with respect to an equitable solution, including the possibility of the mutual termination of this Agreement.

 

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13.9 Compliance with Laws . Notwithstanding anything to the contrary contained herein, all rights and obligations of NovaCal and Alcon are subject to prior compliance with, and each Party shall comply with, all United States and foreign export and import laws, regulations, and orders, and such other United States and foreign laws, regulations, and orders as may be applicable, including obtaining all necessary approvals required by the applicable agencies of the governments of the United States and foreign jurisdictions.

13.10 Interpretation . The captions and headings to this Agreement are for convenience only, and are to be of no force or effect in construing or interpreting any of the provisions of this Agreement. Unless specified to the contrary, references to Articles, Sections or Exhibits mean the particular Articles, Sections or Exhibits to this Agreement and references to this Agreement include all Exhibits hereto. Unless context otherwise clearly requires, whenever used in this Agreement: (i) the words “include” or “including” shall be construed as incorporating, also, “but not limited to” or “without limitation;” (ii) the word “day” or “year” means a calendar day or year unless otherwise specified; (iii) the word “notice” shall mean notice in writing (whether or not specifically stated) and shall include notices, consents, approvals and other written communications contemplated under this Agreement; (iv) the words “hereof,” “herein,” “hereby” and derivative or similar words refer to this Agreement (including any Exhibits); (v) the word “or” shall be construed as the inclusive meaning identified with the phrase “and/or;”(vi) provisions that require that a Party, the Parties or a committee hereunder “agree,” “consent” or “approve” or the like shall require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter, approved minutes or otherwise; (vii) words of any gender include the other gender; (viii) words using the singular or plural number also include the plural or singular number, respectively; and (ix) references to any specific law, rule or regulation, or article, section or other division thereof, shall be deemed to include the then-current amendments thereto or any replacement law, rule or regulation thereof.

13.11 Counterparts . This Agreement may be executed in two counterparts, each of which shall be deemed an original, and all of which together, shall constitute one and the same instrument.

[The remainder of this page intentionally left blank; the signature page follows.]

 

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IN WITNESS WHEREOF , the Parties have executed this Agreement in duplicate originals by their duly authorized representatives as of the date and year first above written.

 

NOVACAL PHARMACEUTICALS, INC.     ALCON MANUFACTURING, LTD.
By:   /s/ R ON N AJAFI     By:   /s/ C ARY R. R AYMENT
Name:   Ron Najafi, PhD     Name:   Cary R. Rayment
Title:   Chairman and CEO     Title:   Chairman, Chief Executive Officer

List of Exhibits:

Exhibit 1.3 : Aganocide Compound

Exhibit 3.2 : Discovery Research Plan Guidelines

Exhibi t 6.1.4: Manufacturing Cost

Exhibit 6.1.5 : Supply Agreement Terms and Conditions

Exhibit 8.2 : Minimum Number of NovaCal FTEs

Exhibit 10.4.1 : Press Release


EXHIBIT 1.3

AGANOCIDE COMPOUND

For purposes of this Agreement and for purposes of providing specific examples but without limiting the definition in Section 1.3, Aganocide Compounds shall include [***].

 

Compound       
NVC-422   
NVC-521   
NVC-524   
NVC-530   
NVC-539   
NVC-546   

 

[***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission.


EXHIBIT 3.2

DISCOVERY RESEARCH PLAN GUIDELINES

This exhibit is the initial Discovery Research Plan Guidelines under which Alcon and NovaCal will work together in the discovery and characterization of currently identified and newly identified Aganocides. The Plan will be finalized within 60 days of the Effective Date of the Contract per Article 3, section 3.1 and 3.2.

Compounds identified through this Discovery Research Plan which are deemed suitable candidates for development will be recommended to the Coordination Committee for review per Article 3, section 3.4.

NovaCal shall be primarily responsible for the activities under the Discovery Research Program per Article 3, section 3.3. The Discovery Research Plan will be mutually agreed upon by the Coordination Committee. Alcon will conduct agreed upon activities to facilitate discovery and characterization of novel Aganocides. NovaCal will conduct Research activities to specifications accepted by Alcon and agreed to by the Coordination Committee.

The Coordination Committee will agree on the activities under the Discovery Research Program and will periodically review the progress and recommend future directions of the Discovery Research Plan per Articles 2 and 3.

 

  I. Discovery Objectives

[***]

 

  II. [***]

 

  a. NovaCal activities

[***]

 

  b. Alcon activities for pre-IND and Proof of Concept Studies

[***]

 

  III. Novel additional compounds

 

  a. NovaCal Discovery

[***]

 

[***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission.


  b. Alcon Discovery and pre-IND/IDE activities

[***]

 

[***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission.

-2-


EXHIBIT 6.1.4

MANUFACTURING COST

Manufacturing Cost ” means, with respect to a Development Compound supplied by NovaCal or a Licensed Product supplied by Alcon hereunder, amounts incurred or accounted for by NovaCal for the sum of (i) Actual Materials Cost, (ii) Actual Labor Cost, and (iii) Allocable Overhead, in each case calculated in accordance with GAAP; provided, however with respect to Development Compound (or component thereof) acquired or licensed by NovaCal from a Third Party or a Licensed Product (or component thereof) acquired or licensed by Alcon from a Third Party, the Manufacturing Costs for such Development Compound or Licensed Product, as applicable, (or component thereof) shall be deemed to be the amount paid therefor to such Third Party, plus Actual Materials Cost, Actual Labor Cost, Allocable Overhead incurred or accounted for by NovaCal or Alcon, and licensing fees (if any) paid to Third Parties, as applicable for the quality control, storage, handling, processing, preparation and transfer of such purchased Development Compound or Licensed Product.

(A) “ Actual Materials Cost ” means the actual unit cost of all raw materials multiplied by the actual number of units of such raw materials consumed in the manufacture of Development Compound or the Manufacture of Licensed Product, as applicable, including any yield variances and any write-offs caused by obsolescence, accident and book-to-physical differences, in each case occurring in the normal course of the manufacturing process.

(B) “ Actual Labor Cost ” means actual employee costs allocable to the manufacture Development Compound or Manufacture of Licensed Product, as applicable, which are as follows: salaries, payroll taxes, employee benefits, holiday, sickness, overtime pay and bonuses with respect to such employees. For clarity, Actual Labor Costs shall exclude any employee costs associated with equity incentive plans.

(C) “ Allocable Overhead ” means: (i) depreciation of or rent/lease expenses for property, plant or equipment, (ii) plant management (e.g., supervisors, human resources and purchasing), (iii) plant services (e.g., engineering, and production planning), (iv) plant utilities, (v) plant maintenance, (vi) freight and storage costs (at any stage in manufacturing), (vii) cost accounting, data processing and information systems services, (viii) non-reimbursable taxes and duties (excluding income tax), (ix) expenses related to environmental protection, (x) costs of security and surveillance, and (xi) costs of plant fire insurance protection, in each case allocable to or used in the manufacture of Development Compound or Manufacture of Licensed Product, as applicable. For clarity, Allocable Overhead excludes (a) all costs and charges related to or occasioned by or for idle or excess manufacturing capacity, (b) the manufacture of other products (other than Development Compound or Licensed Product), (c) depreciation of or rent/lease expenses for property, plant or equipment not related to manufacturing of Development Compound or Manufacturing of Licensed Product, as applicable, and (d) allocation of general corporate overhead (e.g., executive management, investor relations, business development, legal affairs, finance and cost of capital, whether or not such capital is attributable to the manufacture of any Development Compound or Manufacture of any Licensed Product).


EXHIBIT 6.1.5

SUPPLY AGREEMENT TERMS AND CONDITIONS

The Supply Agreements shall include and be consistent with the following terms and conditions:

Product Supply : NovaCal will have the right and obligation to supply (or have supplied), to the extent provided in Section 6.1 of the Agreement, Development Compounds meeting the applicable Specification that are forecasted and ordered by Alcon, its Affiliates and Marketing Partners. Similarly, Alcon will have the right and obligation to supply (or have supplied), to the extent provided in Section 6.1 of the Agreement, Development Compounds and Licensed Products meeting the applicable Specifications that are forecasted and ordered by NovaCal, its Affiliates and Co-Marketing Partners. Each such particular Development Compound or Licensed Product, hereinafter referred to as a “ Product ”. “ Specification ” will be defined in more detail in the Quality Agreement (as described below) to mean the mutually agreed upon analytical and quality specifications (including GMP) for the Development Compound or Product, as applicable, necessary to meet the requirement of the applicable Marketing Approvals or otherwise mutually agreed by the Parties, including, as applicable, packaging specifications.

Forecast : The Party so ordering the Product (the “ Ordering Party ”) will provide the other Party (the “ Supplying Party ”) with a twelve (12) month rolling forecast, the first three (3) months of which shall be binding for the requirements for Product. The requirements and responsibilities of both Parties shall be finalized in the Supply Agreement.

Orders : Orders will be made pursuant to a mutually agreed form of purchase order. Any additional or inconsistent terms or conditions of any purchase order, acknowledgment or similar standardized form given or received shall have no effect and such terms and conditions will be excluded.

Invoicing : The Supplying Party will invoice the Ordering Party for Product at the time of shipment. All payments will be made net 30 days from date of invoice.

Shipping : Delivery of Product shall be FOB (U.C.C) place of manufacture. Supplying Party shall load all Product onto Ordering Party’s designated carrier at Supplying Party’s facilities, and title and risk of loss shall thereof pass to Ordering Party when the Product is loaded.

Quality : The process for release of each Product, and the responsibilities for GMP compliance and regulatory activities will be detailed in a “Quality Agreement ”. The Quality Agreement will be negotiated between Supplying Party and Ordering Party in good faith and include standard and customary terms and conditions and be incorporated into the Supply Agreement by reference and executed prior to manufacture of process validation lots. In the event that Supplying Party and Ordering Party are unable to agree on whether certain lot of Product is defective, retained samples of the lot in question shall be submitted to a mutually agreed independent reference lab to be described

 

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in more detail in the Quality Agreement. The results of the independent lab testing shall be binding. The cost of testing shall be borne by Supplying Party if such lab determines that the Product is found to be defective or by Ordering Party if such lab determines that the Product is in conformance with the Specifications. In the event of a determination that the Product is not defective, Ordering Party shall promptly pay Supplying Party for all such Product, including any allegedly defective Product shipped to Ordering Party. In the event of a determination that the Product is defective, the order for such Product will be canceled and Ordering Party will make a separate order therefor after discussions with Supplying Party.

Supply Failure : If Supplying Party materially fails to supply, or have supplied, quantities of Product that it is required to supply, except as a result of a default by Ordering Party or force majeure event, Supplying Party will, at Ordering Party’s written request, provide Ordering Party (including any Third Party contract manufacturer designated by ARL) with access to and the right to use, without charge (other than the administrative costs of transfer), all Supplying Party manufacturing intellectual property (including without limitation, Patents, Know-How, and related information and materials) necessary or reasonably useful to manufacture such Product, except that Ordering Party shall not exercise such rights (a) through a competitor of Supplying Party or (b) in any country that does not adhere to and respect internationally recognized intellectual property and trade regulations. The Supply Agreement will include mechanisms for the transfer of such intellectual property to Ordering Party in the event of such failure to supply. If Ordering Party elects to exercise such rights to manufacture or have manufactured Product, then, at such time as Supplying Party or its contract manufacturer can reasonably demonstrate its ability to again supply Product in accordance with the Supply Agreement, such manufacturing rights of Ordering Party shall cease and Supplying Party shall have the right to supply Product.

Term : The term of the Supply Agreement will be coextensive with the Agreement and will be subject to termination on the same terms as the Agreement.

 

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EXHIBIT 8.2

MINIMUM NUMBER OF NOVACAL FTES

 

Calendar Year

  

Number of NovaCal FTE s to be funded

under Discovery or Development Plans

[***]

   [***]

[***]

   [***]

*The number of NovaCal FTEs to be funded by Alcon hereunder for calendar years [***] shall be agreed to by the Coordination Committee on an annual basis during the third quarter of the immediately preceding year. However, the number of NovaCal FTEs so funded during any such calendar year shall not be less than [***] of the average number of funded NovaCal FTEs in the prior calendar year.

Funding for the FTEs in calendar year 2006 would commence upon the Coordination Committee’s agreement on the scope of the Discovery Research Program. Alcon’s FTE funding commitment will be paid semi-annually in advance (i.e., January and July of each year) as described in Section 8.2.1. During any calendar year, Alcon may reduce the number of NovaCal FTEs to be funded hereunder by providing three (3) months notice to NovaCal specifying the reduction in NovaCal FTEs proposed, but in no event shall Alcon reduce the number of applicable FTEs for such calendar year by more than [***] of the number established pursuant to the above paragraph, in which case the Coordination Committee shall promptly meet and adjust the Discovery Plan or Development Plans, as applicable, to accommodate such reduction. Notwithstanding anything herein to the contrary, in no event shall any FTE payment made by Alcon be refundable or creditable.

 

[***] Confidential treatment has been requested for the bracketed portions. The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission.

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EXHIBIT 10.4.1

PRESS RELEASE

NovaCal Licenses Novel Anti-Infective Compounds for Eye, Ear and Sinus Infections to Alcon

EMERYVILLE, CA. September __, 2006 – NovaCal Pharmaceuticals Inc. (“NovaCal”) announced today that it has signed a collaboration and license agreement with an affiliate of Alcon, Inc. (NYSE:ACL), the world’s leading eye care company, to research, develop and commercialize NovaCal’s novel Aganocide™ compounds to treat infections of the eye, ear and sinus, including those associated with persistent bacterial biofilms.

Under the terms of the agreement, Alcon Manufacturing Limited will make an up front payment to NovaCal, as well as ongoing payments associated with the achievement of development milestones and approval of products incorporating Aganocide compounds. Alcon will also provide research funding to NovaCal for four years as part of a collaborative research program, which is extendable by Alcon for additional periods. Alcon will be responsible for all clinical development costs and NovaCal will receive royalties on the sales of products containing any Aganocide™ compound.

NovaCal retains all rights to the Aganocide™ compounds, including new compounds resulting from the collaboration, for other therapeutic indications and uses. NovaCal also retains the right to co-market products resulting from the agreement for ear and sinus infections in major markets in Asia.

“We are delighted by this important deal with Alcon, who already has been conducting preliminary testing of NovaCal’s Aganocide™ compounds over the past year. Alcon is the worldwide leader in the eye, with outstanding research, clinical development and marketing capabilities in the ophthalmic field,” said Dr. Ron Najafi, Ph.D., Chairman and Chief Executive Officer of NovaCal. “We believe our partnership with Alcon is a major step forward in fully developing this new class of non-antibiotic anti-infective compounds.”

“NovaCal’s Aganocide™ compounds are of great interest to us because of their broad application to bacterial and viral infections as well as their potential in multiple therapeutic areas,” said Scott Krueger, PhD, Alcon’s vice president R&D for pharmaceutical development. “These are novel compounds that are currently unexampled in topical treatment of infections in the eye, ear and nose.”


About NovaCal Pharmaceuticals

Novacal is a private clinical stage biopharmaceutical company committed to developing its proprietary class of new, non-antibiotic anti-infective compounds, known as Aganocide compounds, and products based thereon. The Aganocide compounds destroy bacteria by attacking multiple sites and are also effective against bacteria that are protected by biofilm. NovaCal’s drug development programs are aimed at treating or preventing infections that have a major impact on patients including those caused by multi-drug resistant bacteria. NovaCal’s internal programs largely focus on hospital acquired infections that cause increased morbidity and mortality and that are difficult to treat with existing antibiotics. NovaCal’s first compound, NVC-101, is in exploratory clinical trials in the United States for the treatment of infected venous ulcers. NovaCal’s second compound, NVC-422, is expected to enter clinical trials in the first quarter of 2007. For more information on NovaCal please visit www.novacal.com

About Alcon

Alcon, Inc. is the world’s leading eye care company, with global sales of $4.4 billion in 2005. Alcon, which has been dedicated to the ophthalmic industry for more than 50 years, develops, manufactures and markets pharmaceuticals, surgical equipment and devices, contact lens solutions and other vision care products that treat diseases, disorders and other conditions of the eye. In addition to its eye products, Alcon markets Ciprodex ® otic suspension, the leading topical ear infection drug in the U.S. It also has developed an investigational nasal allergy drug, Patanase ® nasal spray, for the treatment of seasonal rhinitis, for which a New Drug Application has been filed with the U.S. Food and Drug Administration. Ciprodex ® is licensed from Bayer, AG.

Caution Concerning Forward-Looking Statements

Note Regarding Forward-Looking Statements: This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). NovaCal Pharmaceuticals, Inc. (the “Company”) disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, any statements relating to the timing, scope or expected outcome of the Company’s or its partner’s clinical development of its drug candidates, the potential benefits of the Company’s drug candidates and the size of the potential market for the Company’s products. Such statements are based on management’s current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in discovery, development, testing, regulatory approval, production and marketing of the Company’s drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Company’s drug candidates that could slow or prevent product approval or market acceptance (including the risk that current and past results of clinical trials are not necessarily indicative of future results of clinical trials), the uncertainty of patent protection for the Company’s intellectual property or

 

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trade secrets, the Company’s ability to obtain additional financing if necessary and unanticipated research and development and other costs. For further information regarding these and other risks related to the Company’s business, investors should consult the Company’s information at www.novacal.com.

Press Contacts:

NovaCal:

Ron Najafi, 510-595-1100 x150 or Jack O’Reilly, 510-595-1100 x151

www.novacal.com

 

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EXHIBIT 10.13

NOVABAY PHARMACEUTICALS, INC.

DIRECTOR COMPENSATION PLAN

 

I. INTRODUCTION.

The chairs of the Compensation Committee and Audit Committees of the Board of Directors of NovaBay Pharmaceuticals, Inc. (the “Company”) are treated separately from other committee members, and each chair is awarded benefits for attending and chairing the meetings (up to five per calendar year) of such chair’s subject committee (in order to induce focus on such chair’s subject committee responsibilities). Each non-chair member of a committee (or committees), however, is awarded benefits for attending meetings (up to five per calendar year) of any committee in which he or she is a member. These benefits to the chairs and to the committee members are in addition to the benefits as may be awarded to them, and to any non-committee, non-employee director for attendance at Board meetings (up to six per calendar year).

Inasmuch as the attendance at a Board or committee meeting is most contributory and significant with physical attendance, any attendance by telephone will be entitled to one-half the benefit awarded for an in person attendance, with such telephone attendance counted as one meeting against the relevant maximum number permitted. The referenced Board or committee meetings, for which shares and cash are to be awarded under this plan, mean duly constituted meetings and not informal planning sessions, lunches, employee gatherings, informational “get togethers” and the like. On the other hand, a director may be given credit for attendance at a Board meeting (either in full or partially), in the event that a majority of the Board members, other than the absent member, determines that the inability to attend is due to a valid excuse, such as jury duty requirements.

All common stock awarded shall be determined by the dollar amount indicated, divided by the per share common stock value as of the meeting date, taken at the average of the high and low values on that date, but in no event will such value be taken at less than $1.00 per share. Such $1.00 per share minimum will be appropriately adjusted for any intervening reverse stock splits, stock splits, stock dividends or other stock combinations or divisions. Any fractional share resulting from a given valuation calculation shall be disregarded, although the cash award will not be otherwise affected. If the duration of a meeting, due to a recess or otherwise, continues for more than one day, the meeting will be deemed attended, if the director or member attends all days (with the one-half benefit applying for the entire meeting, if any of such days is attended by telephone), and the common stock valuation shall be made as to the last day of such meeting.

 

II. COMPENSATION PLAN FOR NON-EMPLOYEE DIRECTORS, COMPENSATION AND AUDIT COMMITTEE CHAIRS AND COMMITTEE MEMBERS.

 

  A. New Directors . The Board may grant stock options to newly elected non-employee directors upon their first appointment or election to the Board. Such options shall vest one-third at the end of the first year and one-twelfth at the end of each calendar quarter after the end of the first year.

 

  B. Calendar Year 2007 . (In addition, vesting of the options previously granted continues in 2007.)

 

  1. Directors . Each non-employee director will be entitled to (i) $2,100 in common stock and (ii) $1,400 in cash for each Board meeting (up to six) attended.

Maximum per Director—$12,600 in shares and $8,400 in cash (or $21,000 total for both).

 

  2. Compensation and Audit Committee Chairs . Each chair will be entitled to (i) $900 in common stock and (ii) $600 in cash for chairing each relevant Compensation or Audit Committee meeting (up to five), as the case may be, with no benefits for other committee meetings attended.

Maximum per Chair—$4,500 in shares and $3,000 in cash (or $7,500 total for both).


Maximum (with director benefits)—$17,100 in shares and $11,400 in cash (or $28,500 total for both).

 

  3. Committee Members (other than above chairs) . Each committee member will be entitled to (i) $450 in common stock and (ii) $300 in cash for each committee meeting (up to five), regardless of the committee, attended.

Maximum per Member—$2,250 in shares and $1,500 in cash (or $3,750 total for both).

Maximum (with director benefits)—$14,850 in shares and $9,900 in cash (or $24,750 total for both).

 

  C. Calendar Year 2008 . (Vesting of the options previously granted is completed before 2008.)

 

  1. Directors . Each non-employee director will be entitled to (i) $2,700 in common stock and (ii) $1,800 in cash for each Board meeting (up to six) attended.

Maximum per Director—$16,200 in shares and $10,800 in cash (or $27,000 total for both).

 

  2. Compensation and Audit Committee Chairs . Each chair will be entitled to (i) $1,200 in common stock and (ii) $800 in cash for chairing each relevant Compensation or Audit Committee meeting (up to five), as the case may be, with no benefits for other Committee meetings attended.

Maximum per Chair—$6,000 in shares and $4,000 in cash (or $10,000 total for both).

Maximum (with director benefits)—$22,200 in shares and $14,800 in cash (or $37,000 total for both).

 

  3. Committee Members (other than above chairs) . Each committee member will be entitled to (i) $600 in common stock and (ii) $400 in cash for each committee meeting (up to five), regardless of the committee, attended.

Maximum per Member—$3,000 in shares and $2,000 in cash (or $5,000 total for both).

Maximum (with director benefits)—$19,200 in shares and $12,800 in cash (or $32,000 total for both).

 

  D. Calendar Year 2009 . Each non-employee director will be entitled to an annual retainer of $9,000 in common stock and $6,000 of cash, payable on January 15, 2009. In addition, the compensation for attending Board meetings and committee meetings will be the same as in 2008.

 

III. OVERALL PERSPECTIVE.

The plan’s objectives include a desire to compensate the non-employee directors, with a minimum cash flow impact on the Company, and to provide the Company’s stock as compensation to the directors while minimizing the otherwise adverse director tax consequences inherent with stock options.

 

IV. PLAN EFFECTIVENESS

The plan and the compensation to be given under the plan will become effective upon completion of the initial public offering of the Company’s common stock. Director compensation after the calendar year 2009 will require further action and approvals.

Exhibit 10.14

MASTER SECURITY AGREEMENT

dated as of April 23, 2007 (“Agreement”)

THIS AGREEMENT is between General Electric Capital Corporation (together with its successors and assigns, if any, “Secured Party”) and NovaBay Pharmaceuticals, Inc. (“Debtor”). Secured Party has an office at 83 Wooster Heights Road, Danbury, CT 06810. Debtor is a corporation organized and existing under the laws of the state of CA (“the State”). Debtor’s mailing address and chief place of business is 5980 Horton Street, Suite, 550, Emeryville, CA 94608.

 

1. CREATION OF SECURITY INTEREST.

Debtor grants to Secured Party, its successors and assigns, a security interest in and against all property listed on any collateral schedule now or in the future annexed to or made a part of this Agreement (“Collateral Schedule”), and in and against all additions, attachments, accessories and accessions to such property, all substitutions, replacements or exchanges therefor, and all insurance and/or other proceeds thereof (all such property is individually and collectively called the “Collateral”). This security interest is given to secure the payment and performance of all debts, obligations and liabilities of any kind whatsoever of Debtor to Secured Party, now existing or arising in the future, including but not limited to the payment and performance of certain Promissory Notes from time to time identified on any Collateral Schedule (collectively “Notes” and each a “Note”), and any renewals, extensions and modifications of such debts, obligations and liabilities (such Notes, debts, obligations and liabilities are called the “Indebtedness”).

 

2. REPRESENTATIONS, WARRANTIES AND COVENANTS OF DEBTOR.

Debtor represents, warrants and covenants as of the date of this Agreement and as of the date of each Collateral Schedule that:

(a) Debtor’s exact legal name is as set forth in the preamble of this Agreement and Debtor is, and will remain, duly organized, existing and in good standing under the laws of the State set forth in the preamble of this Agreement, has its chief executive offices at the location specified in the preamble, and is, and will remain, duly qualified and licensed in every jurisdiction wherever necessary to carry on its business and operations;

(b) Debtor has adequate power and capacity to enter into, and to perform its obligations under this Agreement, each Note and any other documents evidencing, or given in connection with, any of the Indebtedness (all of the foregoing are called the “Debt Documents”);

(c) This Agreement and the other Debt Documents have been duly authorized, executed and delivered by Debtor and constitute legal, valid and binding agreements enforceable in accordance with their terms, except to the extent that the enforcement of remedies may be limited under applicable bankruptcy and insolvency laws;

(d) No approval, consent or withholding of objections is required from any governmental authority or instrumentality with respect to the entry into, or performance by Debtor of any of the Debt Documents, except any already obtained;

(e) The entry into, and performance by, Debtor of the Debt Documents will not (i) violate any of the organizational documents of Debtor or any judgment, order, law or regulation applicable to Debtor, or (ii) result in any breach of or constitute a default under any contract to which Debtor is a party, or result in the creation of any lien, claim or encumbrance on any of Debtor’s property (except for liens in favor of Secured Party) pursuant to any indenture, mortgage, deed of trust, bank loan, credit agreement, or other agreement or instrument to which Debtor is a party;

(f) There are no suits or proceedings pending in court or before any commission, board or other administrative agency against or affecting Debtor which could, in the aggregate, have a material adverse effect on Debtor, its business or operations, or its ability to perform its obligations under the Debt Documents, nor does Debtor have reason to believe that any such suits or proceedings are threatened;

(g) All financial statements delivered to Secured Party in connection with the Indebtedness have been prepared in accordance with generally accepted accounting principles, and since the date of the most recent financial statement, there has been no material adverse change in Debtors financial condition;

(h) The Collateral is not, and will not be, used by Debtor for personal, family or household purposes;

(i) The Collateral is, and will remain, in good condition and repair and Debtor will not be negligent in its care and use;


(j) Debtor is, and will remain, the sole and lawful owner, and in possession of, the Collateral, and has the sole right and lawful authority to grant the security interest described in this Agreement;

(k) The Collateral is, and will remain, free and clear of all liens, claims and encumbrances of any kind whatsoever, except for (i) liens in favor of Secured Party, (ii) liens for taxes not yet due or for taxes being contested in good faith and which do not involve, in the judgment of Secured Party, any risk of the sale, forfeiture or loss of any of the Collateral and with respect to which adequate reserves have been set aside for the payment thereof in accordance with GAAP, and (iii) inchoate materialmen’s, mechanic’s, repairmen’s and similar liens arising by operation of law in the normal course of business for amounts which are not delinquent (all of such liens are called “Permitted Liens”); and

(l) Debtor is and will remain in full compliance with all laws and regulations applicable to it including, without limitation, (i) ensuring that no person who owns a controlling interest in or otherwise controls Debtor is or shall be (Y) listed on the Specially Designated Nationals and Blocked Person List maintained by the Office of Foreign Assets Control (“OFAC”), Department of the Treasury, and/or any other similar lists maintained by OFAC pursuant to any authorizing statute, Executive Order or regulation or (Z) a person designated under Section 1(b), (c) or (d) of Executive Order No. 13224 (September 23, 2001), any related enabling legislation or any other similar Executive Orders, and (ii) compliance with all applicable Bank Secrecy Act (“BSA”) laws, regulations and government guidance on BSA compliance and on the prevention and detection of money laundering violations.

 

3. COLLATERAL.

(a) Until the declaration of any default, Debtor shall remain in possession of the Collateral; except that Secured Party shall have the right to possess (i) any chattel paper or instrument that constitutes a part of the Collateral, and (ii) any other Collateral in which Secured Party’s security interest may be perfected only by possession. Secured Party may inspect any of the Collateral during normal business hours after giving Debtor reasonable prior notice. If Secured Party asks, Debtor will promptly notify Secured Party in writing of the location of any Collateral.

(b) Debtor shall (i) use the Collateral only in its trade or business, (ii) maintain all of the Collateral in good operating order and repair, normal wear and tear excepted, (iii) use and maintain the Collateral only in compliance with manufacturers recommendations and all applicable laws, and (iv) keep all of the Collateral free and clear of all liens, claims and encumbrances (except for Permitted Liens).

(c) Secured Party does not authorize and Debtor agrees it shall not (i) part with possession of any of the Collateral (except to Secured Party or for maintenance and repair), (ii) remove any of the Collateral from the continental United States, or (iii) sell, rent, lease, mortgage, license, grant a security interest in or otherwise transfer or encumber (except for Permitted Liens) any of the Collateral.

(d) Debtor shall pay promptly when due all taxes, license fees, assessments and public and private charges levied or assessed on any of the Collateral, on its use, or on this Agreement or any of the other Debt Documents. At its option, Secured Party may discharge taxes, liens, security interests or other encumbrances at any time levied or placed on the Collateral and may pay for the maintenance, insurance and preservation of the Collateral and effect compliance with the terms of this Agreement or any of the other Debt Documents. Debtor agrees to reimburse Secured Party, on demand, all costs and expenses incurred by Secured Party in connection with such payment or performance and agrees that such reimbursement obligation shall constitute Indebtedness.

(e) Debtor shall, at all times, keep accurate and complete records of the Collateral, and Secured Party shall have the right to inspect and make copies of all of Debtor’s books and records relating to the Collateral during normal business hours, after giving Debtor reasonable prior notice.

(f) Debtor agrees and acknowledges that any third person who may at any time possess all or any portion of the Collateral shall be deemed to hold, and shall hold, the Collateral as the agent of, and as pledge holder for, Secured Party. Secured Party may at any time give notice to any third person described in the preceding sentence that such third person is holding the Collateral as the agent of, and as pledge holder for, the Secured Party.

 

4. INSURANCE.

(a) Debtor shall at all times bear the entire risk of any loss, theft, damage to, or destruction of, any of the Collateral from any cause whatsoever.

(b) Debtor agrees to keep the Collateral insured against loss or damage by fire and extended coverage perils, theft, burglary, and for any or all Collateral which are vehicles, for risk of loss by collision, and if requested by Secured Party, against such other risks as Secured Party may reasonably require. The insurance coverage shall be in an amount no less than the full replacement value of the Collateral, and deductible amounts, insurers and policies shall be acceptable to Secured Party. Debtor shall deliver to Secured Party policies or certificates of insurance evidencing such coverage. Each policy shall name Secured Party as additional insured and lender’s loss payee, shall provide for coverage to Secured Party regardless of the breach by Debtor of any warranty or representation made therein, shall not be subject to co-insurance, and shall provide that coverage may not be canceled or altered by the insurer except upon thirty (30) days prior written notice to Secured Party. Debtor appoints Secured Party as its attorney-in-fact to make proof of loss, claim for insurance and adjustments with insurers, and to receive payment of and execute or endorse all documents, checks or drafts in connection with insurance payments. Secured Party shall not act as Debtor’s attorney-in-fact unless Debtor is in default. Proceeds of insurance shall be applied, at the option of Secured Party, to repair or replace the Collateral or to reduce any of the Indebtedness.


5. REPORTS.

(a) Debtor shall promptly notify Secured Party of (i) any change in the name of Debtor, (ii) any change in the state of its incorporation, organization or registration, (iii) any relocation of its chief executive offices, (iv) any relocation of any of the Collateral, (v) any of the Collateral being lost, stolen, missing, destroyed, materially damaged or worn out, or (vi) any lien, claim or encumbrance other than Permitted Liens attaching to or being made against any of the Collateral.

(b) Debtor will deliver to Secured Party financial statements as follows. If Debtor is a privately held company, then Debtor agrees to provide monthly financial statements, certified by Debtor’s president or chief financial officer including a balance sheet, statement of operations and cash flow statement within 30 days of each month end and its complete audited annual financial statements, certified by a recognized firm of certified public accountants, within 120 days of fiscal year end or at such time as Debtor’s Board of Directors receives the audit. If Debtor is a publicly held company, then Debtor agrees to provide quarterly unaudited statements and annual audited statements, certified by a recognized firm of certified public accountants, within 10 days after the statements are provided to the Securities and Exchange Commission (“SEC”). All such statements are to be prepared using generally accepted accounting principles (“GAAP”) and, if Debtor is a publicly held company, are to be in compliance with SEC requirements.

 

6. FURTHER ASSURANCES.

(a) Debtor shall, upon request of Secured Party, furnish to Secured Party such further information, execute and deliver to Secured Party such documents and instruments (including, without limitation, Uniform Commercial Code financing statements) and shall do such other acts and things as Secured Party may at any time reasonably request relating to the perfection or protection of the security interest created by this Agreement or for the purpose of carrying out the intent of this Agreement. Without limiting the foregoing, Debtor shall cooperate and do all acts deemed necessary or advisable by Secured Party to continue in Secured Party a perfected first security interest in the Collateral, and shall obtain and furnish to Secured Party any subordinations, releases, landlord waivers, lessor waivers, mortgagee waivers, or control agreements, and similar documents as may be from time to time requested by, and in form and substance satisfactory to, Secured Party.

(b) Debtor authorizes Secured Party to file a financing statement and amendments thereto describing the Collateral and containing any other information required by the applicable Uniform Commercial Code. Debtor irrevocably grants to Secured Party the power to sign Debtor’s name and generally to act on behalf of Debtor to execute and file applications for title, transfers of title, financing statements, notices of lien and other documents pertaining to any or all of the Collateral; this power is coupled with Secured Party’s interest in the Collateral. Debtor shall, if any certificate of title be required or permitted by law for any of the Collateral, obtain and promptly deliver to Secured Party such certificate showing the lien of this Agreement with respect to the Collateral. Debtor ratifies its prior authorization for Secured Party to file financing statements and amendments thereto describing the Collateral and containing any other information required by the Uniform Commercial Code if filed prior to the date hereof.

(c) Debtor shall indemnify and defend the Secured Party, its successors and assigns, and their respective directors, officers and employees, from and against all claims, actions and suits (including, without limitation, related attorneys’ fees) of any kind whatsoever arising, directly or indirectly, in connection with any of the Collateral, this agreement, any other Debt Document, and the transactions contemplated hereby or thereby, except for claims, actions or suits arising from the gross negligence or willful misconduct of Secured Party or its successors or assigns and their respective directors, officers and employees as determined by final judgment of a court of competent jurisdiction.

 

7. DEFAULT AND REMEDIES.

(a) Debtor shall be in default under this Agreement and each of the other Debt Documents if:

(i) Debtor breaches its obligation to pay when due any installment or other amount due or coming due under any of the Debt Documents and fails to cure the breach within ten (10) days;

(ii) Debtor, without the prior written consent of Secured Party, attempts to or does sell, rent, lease, license, mortgage, grant a security interest in, or otherwise transfer or encumber (except for Permitted Liens) any of the Collateral;

(iii) Debtor breaches any of its insurance obligations under Section 4;

(iv) Debtor breaches any of its other obligations under any of the Debt Documents and fails to cure that breach within thirty (30) days after written notice from Secured Party;

(v) Any warranty, representation or statement made by Debtor in any of the Debt Documents or otherwise in connection with any of the Indebtedness shall be false or misleading in any material respect;


(vi) Any of the Collateral is subjected to attachment, execution, levy, seizure or confiscation in any legal proceeding or otherwise, or if any legal or administrative proceeding is commenced against Debtor or any of the Collateral, which in the good faith judgment of Secured Party subjects any of the Collateral to a material risk of attachment, execution, levy, seizure or confiscation and no bond is posted or protective order obtained to negate such risk;

(vii) Debtor breaches or is in default under any other agreement between Debtor and Secured Party;

(viii) Debtor or any guarantor or other obligor for any of the Indebtedness (collectively “Guarantor”) dissolves, terminates its existence, becomes insolvent or ceases to do business as a going concern;

(ix) If Debtor or any Guarantor is a natural person, Debtor or any such Guarantor dies or becomes incompetent;

(x) A receiver is appointed for all or of any part of the property of Debtor or any Guarantor, or Debtor or any Guarantor makes any assignment for the benefit of creditors;

(xi) Debtor or any Guarantor files a petition under any bankruptcy, insolvency or similar law, or any such petition is filed against Debtor or any Guarantor and is not dismissed within forty-five (45) days;

(xii) Debtor’s improper filing of an amendment or termination statement relating to a filed financing statement describing the Collateral;

(xiii) There is a material adverse change in the Debtor’s financial condition as determined solely by Secured Party;

(xiv) Any Guarantor revokes or attempts to revoke its guaranty of any of the Indebtedness or fails to observe or perform any covenant, condition or agreement to be performed under any guaranty or other related document to which it is a party;

(xv) Debtor defaults under any other material obligation for (A) borrowed money, (B) the deferred purchase price of property or (C) payments due under any lease agreement; or

(xvi) At any time during the term of this Agreement Debtor experiences a change of control such that any person or entity acquires either more than 50% of the voting stock of Debtor or all or substantially all of Debtor’s assets, in either case, without Secured Party’s prior written consent.

(b) If Debtor is in default, the Secured Party, at its option, may declare any or all of the Indebtedness to be immediately due and payable, without demand or notice to Debtor or any Guarantor. The accelerated obligations and liabilities shall bear interest (both before and after any judgment) until paid in full at the lower of eighteen percent (18%) per annum or the maximum rate not prohibited by applicable law.

(c) After default, Secured Party shall have all of the rights and remedies of a Secured Party under the Uniform Commercial Code, and under any other applicable law. Without limiting the foregoing, Secured Party shall have the right to (i) notify any account debtor of Debtor or any obligor on any instrument which constitutes part of the Collateral to make payment to the Secured Party, (ii) with or without legal process, enter any premises where the Collateral may be and take possession of and remove the Collateral from the premises or store it on the premises, (iii) sell the Collateral at public or private sale, in whole or in part, and have the right to bid and purchase at said sale, or (iv) lease or otherwise dispose of all or part of the Collateral, applying proceeds from such disposition to the obligations then in default. If requested by Secured Party, Debtor shall promptly assemble the Collateral and make it available to Secured Party at a place to be designated by Secured Party which is reasonably convenient to both parties. Secured Party may also render any or all of the Collateral unusable at the Debtor’s premises and may dispose of such Collateral on such premises without liability for rent or costs. Any notice that Secured Party is required to give to Debtor under the Uniform Commercial Code of the time and place of any public sale or the time after which any private sale or other intended disposition of the Collateral is to be made shall be deemed to constitute reasonable notice if such notice is given to the last known address of Debtor at least five (5) days prior to such action.

(d) Proceeds from any sale or lease or other disposition shall be applied: first, to all costs of repossession, storage, and disposition including without limitation attorneys’, appraisers’, and auctioneers’ fees; second, to discharge the obligations then in default; third, to discharge any other Indebtedness of Debtor to Secured Party, whether as obligor, endorser, guarantor, surety or indemnitor; fourth, to expenses incurred in paying or settling liens and claims against the Collateral; and lastly, to Debtor, if there exists any surplus. Debtor shall remain fully liable for any deficiency.

(e) Debtor agrees to pay all reasonable attorneys’ fees and other fees, costs and expenses incurred by Secured Party (including, without limitation, the allocated cost of in-house legal counsel) in connection with the enforcement, assertion, defense or preservation of Secured Party’s rights and remedies under this Agreement, or if prohibited by law, such lesser sum as may be permitted. Debtor further agrees that such fees and costs shall constitute Indebtedness.

(f) Secured Party’s rights and remedies under this Agreement or otherwise arising are cumulative and may be exercised singularly or concurrently. Neither the failure nor any delay on the part of the Secured Party to exercise any right, power or privilege under this Agreement shall operate as a waiver, nor shall any single or partial exercise of any right, power or privilege preclude any other or further exercise of that or any other right, power or privilege. SECURED PARTY SHALL NOT BE DEEMED TO HAVE WAIVED ANY OF ITS RIGHTS UNDER THIS AGREEMENT OR UNDER ANY OTHER AGREEMENT,


INSTRUMENT OR PAPER SIGNED BY DEBTOR UNLESS SUCH WAIVER IS EXPRESSED IN WRITING AND SIGNED BY SECURED PARTY. A waiver on any one occasion shall not be construed as a bar to or waiver of any right or remedy on any future occasion.

(g) DEBTOR AND SECURED PARTY UNCONDITIONALLY WAIVE THEIR RIGHTS TO A JURY TRIAL OF ANY CLAIM OR CAUSE OF ACTION BASED UPON OR ARISING OUT OF THIS AGREEMENT, ANY OF THE OTHER DEBT DOCUMENTS, ANY OF THE INDEBTEDNESS SECURED HEREBY, ANY DEALINGS BETWEEN DEBTOR AND SECURED PARTY RELATING TO THE SUBJECT MATTER OF THIS TRANSACTION OR ANY RELATED TRANSACTIONS, AND/OR THE RELATIONSHIP THAT IS BEING ESTABLISHED BETWEEN DEBTOR AND SECURED PARTY. THE SCOPE OF THIS WAIVER IS INTENDED TO BE ALL ENCOMPASSING OF ANY AND ALL DISPUTES THAT MAY BE FILED IN ANY COURT. THIS WAIVER IS IRREVOCABLE. THIS WAIVER MAY NOT BE MODIFIED EITHER ORALLY OR IN WRITING. THE WAIVER ALSO SHALL APPLY TO ANY SUBSEQUENT AMENDMENTS, RENEWALS, SUPPLEMENTS OR MODIFICATIONS TO THIS AGREEMENT, ANY OTHER DEBT DOCUMENTS, OR TO ANY OTHER DOCUMENTS OR AGREEMENTS RELATING TO THIS TRANSACTION OR ANY RELATED TRANSACTION. THIS AGREEMENT MAY BE FILED AS A WRITTEN CONSENT TO A TRIAL BY THE COURT.

 

8. MISCELLANEOUS.

(a) This Agreement, any Note and/or any of the other Debt Documents may be assigned, in whole or in part, by Secured Party without notice to Debtor, and Debtor agrees not to assert against any such assignee, or assignee’s assigns, any defense, set-off, recoupment claim or counterclaim which Debtor has or may at any time have against Secured Party for any reason whatsoever. Debtor agrees that if Debtor receives written notice of an assignment from Secured Party, Debtor will pay all amounts payable under any assigned Debt Documents to such assignee or as instructed by Secured Party. Debtor also agrees to confirm in writing receipt of the notice of assignment as may be reasonably requested by Secured Party or assignee.

(b) All notices to be given in connection with this Agreement shall be in writing, shall be addressed to the parties at their respective addresses set forth in this Agreement (unless and until a different address may be specified in a written notice to the other party), and shall be deemed given (i) on the date of receipt if delivered in hand or by facsimile transmission, (ii) on the next business day after being sent by express mail, and (iii) on the fourth business day after being sent by regular, registered or certified mail. As used herein, the term “business day” shall mean and include any day other than Saturdays, Sundays, or other days on which commercial banks in New York, New York are required or authorized to be closed.

(c) Debtor agrees to pay all reasonable attorneys’ fees and all other fees, costs and expenses incurred by Secured Party (including, without limitation, the allocated cost of in-house legal counsel) in connection with the preparation, negotiation and closing of the transactions contemplated in this Agreement and all related documents and schedules and in connection with the continued administration thereof, including, without limitation, any amendments, modifications, consents or waivers thereof and in connection with the protection, monitoring or preservation of the Collateral. Debtor further agrees that such fees and costs shall constitute Indebtedness.

(d) Secured Party may correct patent errors and fill in all blanks in this Agreement or in any Collateral Schedule consistent with the agreement of the parties.

(e) Time is of the essence of this Agreement. This Agreement shall be binding, jointly and severally, upon all parties described as the “Debtor” and their respective heirs, executors, representatives, successors and assigns, and shall inure to the benefit of Secured Party, its successors and assigns.

(f) This Agreement and its Collateral Schedules constitute the entire agreement between the parties with respect to the subject matter of this Agreement and supersede all prior understandings (whether written, verbal or implied) with respect to such subject matter. THIS AGREEMENT AND ITS COLLATERAL SCHEDULES SHALL NOT BE CHANGED OR TERMINATED ORALLY OR BY COURSE OF CONDUCT, BUT ONLY BY A WRITING SIGNED BY BOTH PARTIES. Section headings contained in this Agreement have been included for convenience only, and shall not affect the construction or interpretation of this Agreement.

(g) This Agreement shall continue in full force and effect until all of the Indebtedness has been indefeasibly paid in full to Secured Party or its assignee. The surrender, upon payment or otherwise, of any Note or any of the other documents evidencing any of the Indebtedness shall not affect the right of Secured Party to retain the Collateral for such other Indebtedness as may then exist or as it may be reasonably contemplated will exist in the future. This Agreement shall automatically be reinstated if Secured Party is ever required to return or restore the payment of all or any portion of the Indebtedness (all as though such payment had never been made).

(h) Debtor authorizes Secured Party to use its name, logo and/or trademark without notice to or consent by Debtor, in connection with certain promotional materials that Secured Party may disseminate to the public. The promotional materials may include, but are not limited to, brochures, video tape, internet website, press releases, advertising in newspaper and/or other periodicals, lucites, and any other materials relating the fact that Secured Party has a financing relationship with Debtor and such materials may be developed, disseminated and used without Debtor’s review. Nothing herein obligates Secured Party to use Debtor’s name, logo and/or trademark, in any promotional materials of Secured Party.

(i) THIS AGREEMENT AND THE RIGHTS AND OBLIGATIONS OF THE PARTIES HEREUNDER SHALL IN ALL RESPECTS BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH, THE INTERNAL LAWS OF THE STATE OF CONNECTICUT (WITHOUT REGARD TO THE


CONFLICT OF LAWS PRINCIPLES OF SUCH STATE), INCLUDING ALL MATTERS OF CONSTRUCTION, VALIDITY AND PERFORMANCE, REGARDLESS OF THE LOCATION OF THE COLLATERAL.

IN WITNESS WHEREOF, Debtor and Secured Party, intending to be legally bound hereby, have duly executed this Agreement in one or more counterparts, each of which shall be deemed to be an original, as of the day and year first aforesaid.

 

SECURED PARTY:     DEBTOR:
General Electric Capital Corporation     NovaBay Pharmaceuticals, Inc.
By:    / S / D ANIJELA G JENERO     By:   

/ S / J ACK O’R EILLY

Name:    Danijela Gjenero     Name:    Jack O’Reilly
Title:    Duly Authorized Signatory     Title:    CFO


SECRETARY’S CERTIFICATE OF AUTHORITY

I, Robert R. Tufts, do hereby certify that:

(i) I am the duly elected, qualified and acting    x    Secretary   ¨ Assistant Secretary [check one] ( “Secretary” ) of NovaBay Pharmaceuticals, Inc., a corporation organized and existing under the laws of the State of CA (hereinafter, the “Corporation” );

(ii) The Corporation’s organizational documents, including without limitation, the Certificate or Articles of Incorporation, are each in full force and effect on and as of the date hereof;

(iii) Each of the President, any Senior Vice President, or Treasurer of the Corporation is duly authorized for and on behalf of the Corporation to borrow monies from General Electric Capital Corporation ( “GE Capital” ), and/or lease from GE Capital (or sell to and leaseback from GE Capital), equipment and other personal property, and to grant to GE Capital a security interest in any or all of the assets of the Corporation to secure repayment of sums borrowed from or owed to GE Capital, and to execute and deliver to GE Capital any promissory note, security agreement, lease, equipment schedule, certificate of acceptance, or any other agreement, schedule, document, or instrument, which evidences or relates to any loan by GE Capital to the Corporation or any lease of equipment or other personal property from GE Capital (collectively, the “Documents” ), and bind the Corporation in relation to any and all transactions contemplated by the Documents;

(iv) that the execution and delivery of the Documents is not prohibited by or in any manner restricted by the terms of the Corporation’s Certificate or Articles of Incorporation, its by-laws, or of any loan agreement, indenture or contract to which the Corporation is a party or under which it is bound;

(v) that the foregoing authority shall remain in full force and effect, and GE Capital shall be entitled to rely upon same, until written notice of the modification, rescission or revocation of same, in whole or in part, has been delivered to GE Capital, but no such modification, rescission or revocation shall, in any event, be effective with respect to any documents executed or actions taken in reliance upon the foregoing authority before said written notice is delivered to GE Capital;

(vi) there are no actions, suits, proceedings or investigations pending or threatened against or affecting the Corporation before any court, federal, state, provincial, municipal or other governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, or any basis therefore, which involves the possibility of any judgment or liability not covered in full by insurance which could result in any material adverse effect in the property, assets, business, operations or financial conditions of the Corporation, or materially impair the right or ability of the Corporation to carry on its operations substantially as now conducted or anticipated to be conducted in the future, or which questions the validity of the Documents, or the other documents required thereby or any action to be taken to be taken pursuant to any of the foregoing; and

(vii) The following persons are duly elected, qualified and acting officers of the Corporation, holding the offices indicated opposite their respective names and the signature appearing opposite their respective names is the genuine signature of such persons, respectively:

 

Name    Office    Signature
Ron Najafi    President    /s/    R ON N AJAFI        
Jack O’Reilly    Senior Vice President    /s/    J ACK O’R EILLY        

IN WITNESS WHEREOF , I have hereunto set my hand and affixed the seal of said Corporation this 4th day of May     , 2007.

*(Corporate Seal)

/s/    R OBERT R. T UFTS                                                 

“Secretary”


State of CA

County of Alameda

CONSENT TO INSTALLATION AND WAIVER

The undersigned depose and say that:

Each has and claims the interest set forth beneath his signature hereto in and to all that tract, piece or parcel of land (the “Premises”) commonly known as: 5980 Horton Street, Suite 550, Alameda County, Emeryville, CA, 94608

Said premises are presently occupied by NovaBay Pharmaceuticals, Inc. ( “Customer” ). Customer has entered into a lease, security agreement, chattel mortgage or similar agreement dated April 23, 2007 , ( “Agreement” ) with General Electric Capital Corporation ( “Interest Holder” ), whereby the said Interest Holder shall have the ownership of, first lien on or other paramount rights to the personal property ( “Personal Property” ) as described in said Agreement subject only to the Customer’s rights as provided in said Agreement.

THEREFORE, in consideration of One Dollar ($1.00) and other good and valuable consideration the receipt of which is hereby acknowledged and in order to induce the Interest Holder to enter into the Agreement to permit the Customer to locate the Personal Property on the Premises and any assignee to purchase and/or to take any assignment of said Agreement, the undersigned do hereby jointly and severally covenant and agree (and Interest Holder will rely on the undersigned’s agreement) that: (i) the Personal Property has been or may be affixed or otherwise installed or kept at, in, or upon the Premises and that said Personal Property is to remain personal property notwithstanding the manner in which it may become or is affixed to or installed at the premises, (ii) that the Interest Holder’s claim in and to such Personal Property shall remain undiminished and unaffected by such affixation, installation or storage throughout the term of the Agreement and any extension thereof, and until and unless the Interest Holder or any assignee thereof shall formally release or transfer its interests in and to such Personal Property to or in favor of such Customer, and (iii) any interest that the undersigned may have in the Personal Property and any proceeds thereof (including, without limitation, proceeds of any insurance therfor) shall be, and remain, subject and subordinate to the interests of Interest Holder.

The undersigned further agree that the Interest Holder and any assignee may enter upon the Premises at all reasonable times to inspect and/or remove said Personal Property from the Premises whenever it deems it necessary to do so to protect its interest. In connection with the foregoing, Interest Holder agrees to repair or reimburse the undersigned for any material, physical damage actually caused to the Premises by Interest Holder, or its employees or agents, during any such removal or inspection, provided, that, it is understood by the parties hereto that Interest Holder shall not be liable for any diminution in value of the Premises caused by the removal or absence of the Personal Property therefrom. These agreements shall be binding upon, and shall inure to the benefit of, any successors and assigns of the parties hereto.

Each undersigned hereby waives each and every right which he now has in the Personal Property or which he may hereafter acquire under the laws of the State of CA or by virtue of any deed, lease, mortgage or other agreement now in effect or hereafter received by the undersigned to own, levy upon, distrain, seize, restrain or otherwise hold or possess said Personal Property for any reason.

This Consent to Installation and Waiver and any amendments, waivers, consents or supplements hereto or in connection herewith may be executed in any number of counterparts and by different parties hereto in separate counterparts, each of which when so executed and delivered shall be deemed an


original, but all such counterparts together shall constitute but one and the same instrument; signature pages may be detached from multiple separate counterparts and attached to a single counterpart so that all signature pages are physically attached to the same document. Delivery of an executed signature page of this Consent to Installation and Waiver or any delivery contemplated hereby by facsimile or electronic transmission shall be as effective as delivery of a manually executed counterpart thereof.

We appreciate your cooperation in this matter of mutual interest.

 

General Electric Capital Corporation
By:   / S /    D ANIJELA G JENERO        
Name:    Danijela Gjenero
Title:    Duly Authorized Signatory

 

AGREED TO AND ACCEPTED BY:
   
By:    / S /    R ICHARD K. R OBBINS        
Name:    Richard K. Robbins
Title:    President, Wareham Property Group
Date:    5-9-07

Interest in the Premises (check applicable box)

 

  ¨ Owner

 

  ¨ Mortgagee

 

  ¨ Landlord

 

  ¨ Realty Manager


Equipment Concentration Rider

NovaBay Pharmaceuticals, Inc., (“Customer”), on or before April 19, 2008, shall cause the composition and mix of Equipment financed after April 23, 2007 under the Master Security Agreement dated as of April 23, 2007 between Customer and General Electric Capital Corporation to conform to and meet the following concentration requirements (hereinafter “Concentration Requirements”) for each class of Equipment (hereinafter “Equipment Class”) as identified and set forth below. Customer herein represents and warrants that it shall maintain each such Equipment Class and its respective Concentration Requirement from and after such above referenced date and continuing thereafter to the end of the term:

 

Equipment Class

  

Concentration Requirement

      
Laboratory & scientific equipment:    Minimum of 60%   
Computers, networking equipment, Office furniture & equipment:    Maximum of 20%   
Soft costs (leaseholds, software, & similar):    Maximum of 20%   

 

Accepted and Agreed:
NovaBay Pharmaceuticals, Inc.
By:   / S /    J ACK O’R EILLY        
Title:    CFO
Date:    5/10/07

Exhibit 23.1

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

We consent to the use in this Registration Statement on Form S-1 of NovaBay Pharmaceuticals, Inc. (formerly NovaCal Pharmaceuticals, Inc.) of our report dated February 15, 2007 (except as to Note 13, which is as of May 29, 2007) appearing in the Prospectus, which is part of such Registration Statement, and to the reference of us under the heading “Experts” in such Prospectus.

 

    /s/ Davidson & Company LLP
    Chartered Accountants
Vancouver, Canada    
May 29, 2007