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As filed with the Securities and Exchange Commission on September 21, 2006.

Registration No. 333-132921


SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

AMENDMENT NO. 4

TO

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

 


 

Achillion Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

Delaware   2834   52-2113479

(State or Other Jurisdiction of

Incorporation or Organization)

 

(Primary Standard Industrial

Classification Code Number)

 

(I.R.S. Employer

Identification Number)

 


 

300 George Street

New Haven, Connecticut 06511

(203) 624-7000

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

 


 

Michael D. Kishbauch

President and Chief Executive Officer

300 George Street

New Haven, Connecticut 06511

(203) 624-7000

(Name, address, including zip code, and telephone number, including area code, of agent for service)

 


 

Copies to:

 

Steven D. Singer, Esq.

Wilmer Cutler Pickering Hale and Dorr LLP

60 State Street

Boston, MA 02109

(617) 526-6000

  

Jonathan L. Kravetz, Esq.

Brian P. Keane, Esq.

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

One Financial Center

Boston, MA 02111

(617) 542-6000

 


 

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this registration statement.

 

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, as amended, 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

   Amount to be
Registered(1)
   Proposed
Maximum
Aggregate
Offering Price
per Share(2)
   Proposed
Maximum
Aggregate
Offering
Price(2)
   Amount of
Registration
Fee(3)(4)

Common Stock, $0.001 par value per share

   5,175,000    $ 16.00    $ 82,800,000    $ 8,860

 

(1) Includes 675,000 shares of common stock that may be purchased by the underwriters to cover over-allotments, if any.
(2) Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(a) under the Securities Act of 1933, as amended.
(3) Calculated pursuant to Rule 457(a) based on an estimate of the proposed maximum aggregate offering price.
(4) A registration fee of $8,025 has been paid previously in connection with this Registration Statement based on an estimate of the maximum aggregate offering price. The remaining $835 of the registration fee is being paid herewith.

 


 

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 this registration statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.



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The Information in this prospectus is not complete and may be changed. We may not 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.

 

PROSPECTUS (Subject to Completion)

Dated September 21, 2006

 


 

4,500,000 Shares

 

LOGO

 

Common Stock

 

This is an initial public offering of shares of our common stock. We are offering 4,500,000 shares of our common stock. Prior to this offering, there has been no public market for our common stock. We will apply for listing of our common stock on the NASDAQ Global Market under the symbol “ACHN.” We expect that the public offering price will be between $14.00 and $16.00 per share.

 

Our business and an investment in our common stock involve significant risk. These risks are described under the caption “ Risk Factor s” beginning on page 6 of this prospectus.

 

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.

 


 

     Per Share

   Total

Public offering price

   $                   $                 

Underwriting discount

   $      $  

Proceeds, before expenses, to Achillion

   $      $  

 

The underwriters may also purchase up to an additional 675,000 shares from us at the public offering price, less the underwriting discount, within 30 days from the date of this prospectus to cover overallotments.

 

The underwriters expect to deliver the shares against payment in New York, New York on                     , 2006.

 


 

Cowen and Company

CIBC World Markets

 


 

JMP Securities

 

                    , 2006


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TABLE OF CONTENTS

 

Prospectus Summary

   1

Risk Factors

   6
Special Note Regarding Forward-Looking Statements    24

Use of Proceeds

   25

Dividend Policy

   26

Capitalization

   27

Dilution

   29

Selected Financial Data

   31
Management’s Discussion and Analysis of Financial Condition and Results of Operations    32

Business

   46

Management

   73

Principal Stockholders

   85
Certain Relationships and Related Party Transactions    88

Description of Capital Stock

   91

Shares Eligible for Future Sale

   94

Underwriting

   97

Legal Matters

   101

Experts

   101
Where You Can Find More Information    101

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 anyone to provide you with information that is different. We are offering to sell and seeking offers to buy shares of common stock only in jurisdictions where offers and sales are permitted. The information contained in this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or of any sale of the common stock.


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PROSPECTUS SUMMARY

 

The following summary is qualified in its entirety by, and should be read in conjunction with, the more detailed information and financial statements and notes thereto appearing elsewhere in this prospectus. Before you decide to invest in our common stock, you should read the entire prospectus carefully, including the risk factors and financial statements and related notes included in this prospectus.

 

Our Company

 

Overview

 

We are a biopharmaceutical company focused on the discovery, development and commercialization of innovative treatments for infectious diseases. Within the anti-infective market, we are currently concentrating on the development of antivirals and antibacterials. We are targeting our antiviral development efforts on treatments for HIV infection and chronic hepatitis C, and we are directing our antibacterial development efforts toward treatments for serious hospital-based bacterial infections. All of our drug candidates are in the early stages of development, and none of our drug candidates have been approved for commercial sale. We do not expect to have any approved drugs on the market for at least several years. Our two lead drug candidates are elvucitabine, which we are currently evaluating in phase II clinical trials in HIV-infected patients, and ACH-806 (also known as GS 9132), which we are currently evaluating in collaboration with Gilead Sciences, Inc. in a proof-of-concept clinical trial for the treatment of chronic hepatitis C. We are also evaluating our third drug candidate, ACH-702, in late-stage preclinical studies for the treatment of serious hospital-based bacterial infections. Currently available anti-infective therapies have significant therapeutic limitations, such as inadequate potency, diminishing efficacy due to the emergence of drug resistance, and patient non-compliance with treatment regimens due to adverse side effects, complex dosing schedules and inconvenient routes of administration. We believe that our drug candidates have the potential to address these limitations and that our drug discovery capabilities, which have thus far produced two of our three lead drug candidates, will allow us to further expand our product portfolio.

 

We believe that drug development of anti-infectives offers significant advantages. The emergence of drug resistance seen with current antiviral and antibacterial therapy creates a continuing need for new drugs, which we believe provides us with a large and growing business opportunity. In addition, infectious disease research and development programs generally have shorter development cycle times when compared to other therapeutic areas such as oncology, cardiovascular and central nervous system disorders.

 

According to reports published by Datamonitor, worldwide sales for therapies to treat HIV infection, chronic hepatitis C and bacterial infections were $32.6 billion in 2004.

 

Our Drug Candidates

 

Elvucitabine

 

Our lead clinical-stage drug candidate is elvucitabine, an antiviral we are evaluating in phase II clinical trials for the treatment of HIV infection. Elvucitabine is a member of a class of compounds called nucleoside reverse transcriptase inhibitors, or NRTIs, the predominant class of drugs used in the current standard of care for HIV therapy known as Highly Active Antiretroviral Therapy, or HAART. HAART regimens typically consist of a combination of two NRTIs and a third drug from a different class of drugs. However, currently marketed drugs have several therapeutic limitations, including the emergence of HIV strains that are resistant to the drugs, short half-lives which exacerbate drug resistance, inadequate patient compliance due to adverse side effects and complex dosing schedules, and limited combination treatment options due to cross resistance and drug-to-drug interactions. Elvucitabine has demonstrated potent antiviral activity against HIV, including HIV strains that are resistant to frequently prescribed NRTIs. We believe that this profile, along with a long half-life that may delay the emergence of drug resistance, will allow us to position elvucitabine, if approved, favorably in the NRTI market. We are

 

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currently evaluating elvucitabine in phase II clinical trials to further explore the safety and efficacy of elvucitabine in HIV-infected patients. We recently completed one of these phase II clinical trials. Results from this trial demonstrated that patients who received a once-daily 10 mg dose of elvucitabine for seven days experienced a significant mean viral load reduction as compared to those patients who received a placebo. These results are based on a small number of patients in an early-stage clinical trial, and are not necessarily predictive of results in later-stage clinical trials with larger and more diverse patient populations. If we receive additional favorable data from our other phase II trials, we expect to initiate phase III clinical trials in 2007. We currently retain full development and marketing rights to elvucitabine.

 

According to reports published by Datamonitor, the worldwide market for HIV therapeutics was $6.6 billion in 2004.

 

ACH-806

 

Our second clinical-stage drug candidate is ACH-806 (also known as GS 9132), an inhibitor of HCV replication by a novel mechanism involving an enzyme known as HCV protease, which we are currently evaluating in a proof-of-concept clinical trial for the treatment of chronic hepatitis C in collaboration with Gilead Sciences. In preclinical studies, ACH-806 demonstrated potent inhibition of replication of hepatitis C virus, or HCV. The current standard of care, pegylated interferon (which must be administered via injection) in combination with ribavirin, has several limitations, including lack of efficacy against genotype 1 HCV, the most prevalent type of HCV in the United States, and significant side effects. We believe ACH-806 offers several potential advantages compared to currently available treatments, including strong potency, a novel mechanism of action, lack of cross resistance and oral administration. Further, we believe ACH-806 could be used in combination with the current standard of care or with other therapies in development to significantly improve treatment outcomes. In the second quarter of 2006, we completed a phase I clinical trial to evaluate the safety and pharmacokinetics of ACH-806 in healthy volunteers. Results from this trial indicated that ACH-806 is safe and well tolerated in healthy volunteers. Based on these results, we initiated a proof-of-concept clinical trial in August 2006. A proof-of-concept clinical trial is generally a late-stage phase I or early-stage phase II clinical trial, the objective of which is to demonstrate that the tested drug shows a beneficial effect (e.g., a reduction in viral RNA levels). We expect results of this trial to be available in the first quarter of 2007.

 

In November 2004, we entered into a collaboration and exclusive license agreement with Gilead Sciences for the research, development and commercialization of compounds for the treatment of chronic hepatitis C, including ACH-806. We received $10.0 million from Gilead Sciences upon the execution of this agreement in the form of a license fee and equity purchase, and we are entitled to receive up to $157.5 million in development, regulatory and sales milestone payments, assuming simultaneous successful development of a lead and back-up compound, as well as royalties on net sales of products.

 

According to reports published by Datamonitor, the annual worldwide market for hepatitis C treatment was $2 billion in 2004.

 

ACH-702

 

In addition to our antiviral compounds, we are developing ACH-702 for the treatment of serious hospital-based bacterial infections. In several preclinical studies, ACH-702 has exhibited potent antibacterial activity against a large number of medically relevant bacteria, including recent methicillin resistant staphylococcus aureus strains, or MRSA, highly prevalent hospital-based infections. We expect to submit an Investigational New Drug Application, or IND, for ACH-702 to the U.S. Food and Drug Administration, or FDA, during the first quarter of 2007.

 

According to an industry report published by Espicom, the 2006 worldwide market for anti-MRSA antibacterials is projected to be approximately $2.0 billion.

 

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Discovery and Technological Capabilities

 

We believe that continued expansion of our product pipeline will provide strong growth potential and reduce our reliance on the success of any single drug candidate. We have extensive expertise in virology, microbiology and synthetic chemistry and have thus far internally discovered our lead HCV compound, ACH-806, and our late-stage preclinical candidate, ACH-702. In the aggregate, members of our drug discovery, preclinical and clinical development team have contributed to the selection and development of more than 80 clinical candidates and 50 marketed products throughout their careers.

 

Our Strategy

 

Our objective is to become a leading infectious disease-focused biopharmaceutical company. In order to achieve this objective, we intend to:

 

    advance the development of our current drug candidates;

 

    expand our infectious disease portfolio;

 

    accelerate growth through selective collaborations; and

 

    pursue a diversified commercial strategy to maximize the value of each of our drug candidates.

 

Risks Associated with Our Business

 

Our business is subject to numerous risks, as more fully described in the section entitled “Risk Factors” beginning on page 6 immediately following this prospectus summary. We may be unable, for many reasons, including those that are beyond our control, to implement our current business strategy. Those reasons could include unfavorable clinical trial results, delays in obtaining, or a failure to obtain, regulatory approvals for our drug candidates, problems that may arise under our current or future licensing and collaboration agreements, inability to raise additional capital to fund our operations and failure to maintain and protect our proprietary intellectual property assets.

 

We have incurred significant losses since our inception in 1998. We incurred net losses of $15.8 million in 2003, $17.5 million in 2004, $13.6 million in 2005 and $9.0 million in the six months ended June 30, 2006. At June 30, 2006, our accumulated deficit was $107.3 million, and we expect to continue to incur losses for at least the next several years. We have been able to generate only limited amounts of revenue, primarily from payments under our collaboration with Gilead Sciences. None of our drug candidates have been approved for commercial sale. We expect that our annual operating losses will increase significantly over the next several years as we advance elvucitabine, ACH-806, ACH-702 and our other drug candidates through the clinical development process. We are unable to predict the extent of future losses or when we will become profitable, if at all. Even if we succeed in developing and commercializing one or more of our drug candidates, we may never generate sufficient revenue to achieve and sustain profitability.

 

Company Information

 

We were incorporated in Delaware in August 1998. Our principal executive office is located at 300 George Street, New Haven, Connecticut 06511, and our telephone number is (203) 624-7000. Our internet address is www.achillion.com. The information on our web site is not incorporated by reference into this prospectus and should not be considered to be a part of this prospectus. Our internet address is included in this prospectus as an inactive technical reference only.

 

Unless otherwise stated, all references to “us,” “our,” “Achillion,” “we,” the “Company” and similar designations refer to Achillion Pharmaceuticals, Inc. Our logo, trademarks and service marks are the property of Achillion. Other trademarks or service marks appearing in this prospectus are the property of their respective holders.

 

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The Offering

 

Common stock offered by us

4,500,000 shares

 

Common stock to be outstanding after this offering

14,830,391 shares

 

Use of proceeds

We intend to use the net proceeds of this offering to further develop our drug candidates, fund our research and development activities and fund working capital, capital expenditures and other general corporate purposes. See “Use of Proceeds” on page 25 for a more complete description of our intended use of the proceeds from the offering.

 

Proposed NASDAQ Global Market symbol

ACHN

 

The number of shares of common stock to be outstanding after the offering is based on 10,330,391 shares of common stock outstanding as of September 15, 2006. Unless otherwise indicated, the information contained in this prospectus, including the information above, excludes:

 

    807,548 shares of common stock issuable upon the exercise of stock options outstanding as of September 15, 2006, with a weighted average exercise price of $2.28 per share;

 

    335,739 shares of common stock issuable upon the exercise of outstanding warrants as of September 15, 2006, with a weighted average exercise price of $6.08 per share; and

 

    an additional 56,544 shares of common stock reserved as of September 15, 2006 for future stock option grants and purchases under our 1998 stock option plan and an aggregate of 1,000,000 shares of common stock to be reserved for future stock option grants and purchases under our 2006 stock incentive plan and employee stock purchase plan. See “Management—Employee Benefit Plans” on page 82 for a more detailed description of our equity compensation plans.

 


 

In addition, except where we state otherwise, the information we present in this prospectus:

 

    gives effect to the issuance of 8,584,356 shares of convertible preferred stock to the holders of our series B, series C, series C-1 and series C-2 convertible preferred stock upon the closing of this offering in satisfaction of $15,214,791 of accumulated dividends (of which $13,565,496 were accrued for as of June 30, 2006), as required by the terms of the series B, series C, series C-1 and series C-2 convertible preferred stock, which we refer to as the accumulated dividends, assuming for this purpose that the closing of this offering occurs on October 16, 2006;

 

    gives effect to the automatic conversion of all outstanding shares of convertible preferred stock, including accumulated dividends, into 9,815,718 shares of common stock upon the closing of this offering;

 

    reflects a 1-for-8 reverse stock split of our outstanding shares of common stock to be effected prior to the closing of this offering;

 

    reflects the adoption of our restated certificate of incorporation, which we refer to as our certificate of incorporation, and our amended and restated bylaws, which we refer to as our bylaws, to be effective upon the completion of this offering; and

 

    assumes no exercise of the underwriters’ overallotment option to purchase an additional 675,000 shares of our common stock.

 

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Summary Financial Data

 

The following tables present our summary statement of operations data for the years 2001 through 2005 and for the six months ended June 30, 2005 and June 30, 2006 and our summary balance sheet dated as of June 30, 2006. We have derived the financial data for the years ended December 31, 2003, 2004 and 2005 from our audited financial statements which are included elsewhere in this prospectus. We have derived the financial data for the years ended December 31, 2001 and 2002 from our audited financial statements, which are not included in this prospectus. The financial data as of June 30, 2006 and for the six months ended June 30, 2005 and June 30, 2006 are derived from our condensed unaudited financial statements, which in the opinion of management reflect all adjustments, consisting only of normal recurring adjustments, necessary for a fair statement of the financial data. Operating results for these periods are not necessarily indicative of the operating results for a full year. The summary balance sheet data is presented on (a) an actual basis, (b) a pro forma basis to reflect the automatic conversion of all shares of our convertible preferred stock outstanding at June 30, 2006, including accumulated dividends (assuming for this purpose that the closing of the offering occurs on October 16, 2006), into an aggregate of 9,815,718 shares of our common stock effective upon the completion of this offering and (c) a pro forma as adjusted basis to reflect the sale of shares of common stock offered by us in this offering at an assumed initial public offering price of $15.00 per share and after deducting estimated underwriting discounts and commissions and offering expenses payable by us. You should read this information in conjunction with our financial statements, including the related notes, and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included elsewhere in this prospectus.

 

    Years Ended December 31,

   

Six Months

Ended June 30,


 
    2001

    2002

    2003

    2004

    2005

    2005

    2006

 
                                  (unaudited)  
    (in thousands, except per share data)  

Statement of Operations Data:

                                                       

Total operating revenue

  $ —       $ —       $ —       $ 807     $ 8,526     $ 4,865     $ 4,318  

Research and development

    9,658       16,670       13,194       14,841       18,112       9,415       10,969  

General and administrative

    3,073       4,824       3,261       3,181       3,101       1,619       2,216  

Total operating expenses

    12,731       21,494       16,455       18,022       21,213       11,034       13,185  

Net loss

    (11,649 )     (21,042 )     (15,754 )     (17,460 )     (13,575 )   $ (6,628 )     (8,996 )

Net loss applicable to common shareholders

  $ (12,153 )   $ (23,597 )   $ (18,326 )   $ (20,048 )   $ (16,514 )   $ (8,014 )   $ (11,282 )

Net loss per share—basic and diluted

  $ (57.60 )   $ (70.86 )   $ (44.16 )   $ (43.77 )   $ (32.96 )   $ (16.16 )   $ (22.08 )

Weighted average number of shares outstanding—basic and diluted

    211       333       415       458       501       496       511  

 

     As of June 30, 2006

     Actual

    Pro Forma

  

Pro Forma

As Adjusted


    

(unaudited)

(in thousands)

Balance Sheet Data:

                     

Cash, cash equivalents and marketable securities

   $ 20,214     $ 20,214    $ 81,289

Working capital

     13,142       13,142      74,217

Total assets

     25,444       25,444      86,519

Long-term liabilities

     7,605       7,605      7,605

Total liabilities

     17,615       17,615      17,615

Convertible preferred stock

     114,864       —        —  

Total stockholders’ equity (deficit)

     (107,035 )     7,829      68,904

 

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RISK FACTORS

 

This offering involves a high degree of risk. You should carefully consider the risks and uncertainties described below and the other information in this prospectus, including the financial statements and the related notes included at the end of this prospectus, before deciding to invest in shares of our common stock. If any of the following risks or uncertainties actually occurs, our business, prospects, financial condition and operating results would likely suffer, possibly materially. In that event, the market price of our common stock could decline and you could lose all or part of your investment.

 

Risks Related to Our Business

 

We have a limited operating history and have incurred a cumulative loss since inception. If we do not generate significant revenues, we will not be profitable.

 

We have incurred significant losses since our inception in August 1998. At June 30, 2006, our accumulated deficit was approximately $107.3 million. We have not generated any revenue from the sale of drug candidates to date. We expect that our annual operating losses will increase substantially over the next several years as we expand our research, development and commercialization efforts, including:

 

    completing the phase II clinical trials for elvucitabine and, if supported by favorable data from the phase II clinical trials, moving into pivotal phase III clinical trials;

 

    completing the proof-of-concept clinical trial for ACH-806 (also known as GS 9132);

 

    advancing ACH-702 through preclinical testing, submitting an IND application to the FDA and beginning a phase I clinical trial; and

 

    continuing to advance our other research and discovery programs in HIV and HCV, and identifying other infectious disease drug candidates.

 

To become profitable, we must successfully develop and obtain regulatory approval for our drug candidates and effectively manufacture, market and sell any drug candidates we develop. Accordingly, we may never generate significant revenues and, even if we do generate significant revenues, we may never achieve profitability.

 

We will need substantial additional capital to fund our operations, including drug candidate development, manufacturing and commercialization. If we do not have or cannot raise additional capital when needed, we will be unable to develop and commercialize our drug candidates successfully, and our ability to operate as a going concern may be adversely affected.

 

 

We believe that our existing cash and cash equivalents, excluding the proceeds of this offering, as supplemented by research funding pursuant to our collaboration with Gilead Sciences, will be sufficient to support our current operating plan into at least the second quarter of 2007. If we are unable to successfully complete this offering, we will need to obtain alternative financing and/or modify our operational plans. We may seek additional financing through a combination of private and public equity offerings, debt financings and collaboration, strategic alliance and licensing arrangements.

 

To the extent that we raise additional capital through the sale of equity or convertible debt securities, the terms may include adverse liquidation or other preferences. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaboration, strategic alliance and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or drug candidates, or grant licenses on terms that are not favorable to us.

 

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We believe that the net proceeds from this offering, together with interest thereon and our existing cash and cash equivalents, as supplemented by research funding pursuant to our collaboration with Gilead Sciences, will be sufficient to meet our projected operating requirements into the third quarter of 2008. However, we may need to seek additional funding within this period of time. Our drug development programs and the potential commercialization of our drug candidates will require substantial additional cash to fund expenses that we will incur in connection with preclinical and clinical testing, regulatory review, manufacturing and sales and marketing efforts. Our operating plan may change as a result of many factors, including:

 

    the costs involved in the preclinical and clinical development and manufacturing of elvucitabine, ACH-806 and ACH-702;

 

    the costs involved in obtaining regulatory approvals for our drug candidates;

 

    the scope, prioritization and number of programs we pursue;

 

    the costs involved in preparing, filing, prosecuting, maintaining, enforcing and defending patent and other intellectual property claims;

 

    the costs associated with manufacturing our drug candidates;

 

    our ability to enter into corporate collaborations and the terms and success of these collaborations;

 

    our acquisition and development of new technologies and drug candidates; and

 

    competing technological and market developments currently unknown to us.

 

If our operating plan changes, we may need additional funds sooner than planned. Such additional financing may not be available when we need it or may not be available on terms that are favorable to us. In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating plans. If adequate funds are not available to us on a timely basis, or at all, we may be required to:

 

    terminate or delay preclinical studies, clinical trials or other development activities for one or more of our drug candidates; or

 

    delay our establishment of sales and marketing capabilities or other activities that may be necessary to commercialize our drug candidates, if approved for sale.

 

Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights

 

We may seek additional capital through a combination of private and public equity offerings, debt financings and collaboration, strategic and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaboration, strategic alliance and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or drug candidates, or grant licenses on terms that are not favorable to us. If we are unable to obtain adequate financing on a timely basis, we could be required to delay, reduce or eliminate one or more of our drug development programs.

 

We depend heavily on the success of our most advanced drug candidate, elvucitabine, for the treatment of HIV infection, which is still under development.

 

We have invested a significant portion of our efforts and financial resources in the development of our most advanced drug candidate, elvucitabine, for the treatment of HIV infection. Our ability to generate revenues

 

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will depend heavily on the successful development and commercialization of this drug candidate. The commercial success of elvucitabine will depend on several factors, including the following:

 

    our ability to provide acceptable evidence of its safety and efficacy in current and future clinical trials;

 

    receipt of marketing approvals from the FDA and similar foreign regulatory authorities;

 

    establishing commercial manufacturing arrangements with third-party manufacturers;

 

    launching commercial sales of the drug, whether alone or in collaboration with others; and

 

    acceptance of the drug in the medical community and with third-party payors.

 

We are currently studying elvucitabine in two phase II clinical trials. One or both of these clinical trials may not be successful, and the results of our phase II clinical trials, even if positive, may not be necessarily indicative of the results we will obtain in our planned phase III or other subsequent clinical trials that may be required for regulatory approval of this drug candidate. If we are not successful in commercializing elvucitabine, or are significantly delayed in doing so, our business will be materially harmed.

 

Our market is subject to intense competition. If we are unable to compete effectively, our drug candidates may be rendered noncompetitive or obsolete.

 

We are engaged in segments of the pharmaceutical industry that are highly competitive and rapidly changing. Many large pharmaceutical and biotechnology companies, academic institutions, governmental agencies and other public and private research organizations are pursuing the development of novel drugs that target infectious diseases. We face, and expect to continue to face, intense and increasing competition as new products enter the market and advanced technologies become available. In addition to currently approved drugs, there are a significant number of drugs that are currently under development and may become available in the future for the treatment of HIV infection, chronic hepatitis C and serious hospital-based bacterial infections. We would expect elvucitabine, ACH-806 and ACH-702 to compete with the following approved drugs and drug candidates currently under development:

 

    Elvucitabine. If approved, we would expect elvucitabine to compete with currently approved drugs for the treatment of HIV infection, including Epivir (3TC), Retrovir (AZT) and Ziagen (abacavir), marketed by GlaxoSmithKline, Emtriva (FTC) and Viread (tenofovir), marketed by Gilead Sciences, and Zerit (d4T) and Videx (ddI), marketed by Bristol-Myers Squibb. Elvucitabine may also compete with NRTI drug candidates currently in clinical development by other companies such as Avexa, Medivir, Pharmasset and Koronis, as well as other classes of drugs currently in clinical development by companies such as Abbott, Boehringer Ingelheim, Johnson & Johnson, Merck, Panacos, Pfizer, Roche, Schering-Plough, Trimeris and Vertex.

 

    ACH-806. If approved, we would expect ACH-806 to compete with currently approved drugs for the treatment of chronic hepatitis C, including Pegasys and Roferon-A, marketed by Roche, and Intron-A and Peg-Intron, marketed by Schering-Plough. ACH-806 may also compete with drug candidates currently in clinical development by other companies such as Abbott, Anadys, Arrow Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Human Genome Sciences, Idenix Pharmaceuticals, Intermune, Johnson & Johnson, Medivir, Merck, Novartis, Panacos, Pfizer, Pharmasset, Roche, Schering-Plough, Trimeris, Valeant and Vertex.

 

    ACH-702. If approved, we would expect ACH-702 to compete with currently approved drugs for the treatment of bacterial infections, including Cubicin (daptomycin), marketed by Cubist Pharmaceuticals, Zyvox (linezolid), marketed by Pfizer, and Synercid (dalfopristin + quinupristin), marketed by King Pharmaceuticals. ACH-702 may also compete with drug candidates currently in clinical development by other companies such as Intermune, Theravance, Basilea and Johnson & Johnson.

 

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Many of our competitors have:

 

    significantly greater financial, technical and human resources than we have and may be better equipped to discover, develop, manufacture and commercialize drug candidates;

 

    more extensive experience in preclinical testing and clinical trials, obtaining regulatory approvals and manufacturing and marketing pharmaceutical products;

 

    drug candidates that have been approved or are in late-stage clinical development; and/or

 

    collaborative arrangements in our target markets with leading companies and research institutions.

 

Competitive products may render our products obsolete or noncompetitive before we can recover the expenses of developing and commercializing our drug candidates. Furthermore, the development of new treatment methods and/or the widespread adoption or increased utilization of any vaccine for the diseases we are targeting could render our drug candidates noncompetitive, obsolete or uneconomical. If we successfully develop and obtain approval for our drug candidates, we will face competition based on the safety and effectiveness of our drug candidates, the timing of their entry into the market in relation to competitive products in development, the availability and cost of supply, marketing and sales capabilities, reimbursement coverage, price, patent position and other factors. If we successfully develop drug candidates but those drug candidates do not achieve and maintain market acceptance, our business will not be successful.

 

If we are not able to attract and retain key management and scientific personnel and advisors, we may not successfully develop our drug candidates or achieve our other business objectives.

 

We depend upon our senior management and scientific staff for our business success. Key members of our senior team include Michael Kishbauch, our president and chief executive officer, Dr. Milind Deshpande, our senior vice president and chief scientific officer, and Dr. John Pottage, our senior vice president and chief medical officer. Our employment agreements with all of our senior management employees are terminable without notice by the employee. The loss of the service of any of the key members of our senior management may significantly delay or prevent the achievement of drug development and other business objectives. Our ability to attract and retain qualified personnel, consultants and advisors is critical to our success. We face intense competition for qualified individuals from numerous pharmaceutical and biotechnology companies, universities, governmental entities and other research institutions. We may be unable to attract and retain these individuals, and our failure to do so would adversely affect our business.

 

Our business has a substantial risk of product liability claims. If we are unable to obtain appropriate levels of insurance, a product liability claim could adversely affect our business.

 

Our business exposes us to significant potential product liability risks that are inherent in the development, manufacturing and sales and marketing of human therapeutic products. Although we do not currently commercialize any products, claims could be made against us based on the use of our drug candidates in clinical trials. We currently have clinical trial insurance in an amount equal to up to $9.0 million in the aggregate and will seek to obtain product liability insurance prior to the sales and marketing of any of our drug candidates. However, our insurance may not provide adequate coverage against potential liabilities. Furthermore, clinical trial and product liability insurance is becoming increasingly expensive. As a result, we may be unable to maintain current amounts of insurance coverage or obtain additional or sufficient insurance at a reasonable cost to protect against losses that could have a material adverse effect on us. If a claim is brought against us, we might be required to pay legal and other expenses to defend the claim, as well as uncovered damages awards resulting from a claim brought successfully against us. Furthermore, whether or not we are ultimately successful in defending any such claims, we might be required to direct significant financial and managerial resources to such defense, and adverse publicity is likely to result.

 

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Risks Related to the Development of Our Drug Candidates

 

All of our drug candidates are still in the early stages of development and remain subject to clinical testing and regulatory approval. If we are unable to successfully develop and test our drug candidates, we will not be successful.

 

To date, we have not marketed, distributed or sold any drug candidates. The success of our business depends primarily upon our ability to develop and commercialize our drug candidates successfully. Our most advanced drug candidates are elvucitabine, which is currently in phase II clinical trials, and ACH-806 (also known as GS 9132), which is in a proof-of-concept clinical trial. Our other drug candidates are in various stages of preclinical development. Our drug candidates must satisfy rigorous standards of safety and efficacy before they can be approved for sale. To satisfy these standards, we must engage in expensive and lengthy testing and obtain regulatory approval of our drug candidates. Despite our efforts, our drug candidates may not:

 

    offer therapeutic or other improvement over existing, comparable drugs;

 

    be proven safe and effective in clinical trials;

 

    meet applicable regulatory standards;

 

    be capable of being produced in commercial quantities at acceptable costs; or

 

    be successfully commercialized.

 

Positive results in preclinical studies of a drug candidate may not be predictive of similar results in humans during clinical trials, and promising results from early clinical trials of a drug candidate may not be replicated in later clinical trials. A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical trials even after achieving promising results in early-stage development. Accordingly, the results from the completed preclinical studies and clinical trials and ongoing clinical trials for elvucitabine, ACH-806, ACH-702 and our other drug candidates may not be predictive of the results we may obtain in later stage trials. We do not expect any of our drug candidates to be commercially available for at least several years.

 

If we are unable to obtain U.S. and/or foreign regulatory approval, we will be unable to commercialize our drug candidates.

 

Our drug candidates are subject to extensive governmental regulations relating to development, clinical trials, manufacturing and commercialization. Rigorous preclinical testing and clinical trials and an extensive regulatory approval process are required in the United States and in many foreign jurisdictions prior to the commercial sale of our drug candidates. Satisfaction of these and other regulatory requirements is costly, time consuming, uncertain and subject to unanticipated delays. It is possible that none of the drug candidates we are developing will obtain marketing approval. In connection with the clinical trials for elvucitabine, ACH-806, ACH-702 and any other drug candidate we may seek to develop in the future, we face risks that:

 

    the drug candidate may not prove to be efficacious;

 

    the drug may not prove to be safe;

 

    the results may not confirm the positive results from earlier preclinical studies or clinical trials; and

 

    the results may not meet the level of statistical significance required by the FDA or other regulatory agencies.

 

We have limited experience in conducting and managing the clinical trials necessary to obtain regulatory approvals, including approval by the FDA. The time required to complete clinical trials and for FDA and other countries’ regulatory review processes is uncertain and typically takes many years. Our analysis of data obtained from preclinical and clinical activities is subject to confirmation and interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval. We may also encounter unanticipated delays

 

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or increased costs due to government regulation from future legislation or administrative action or changes in FDA policy during the period of product development, clinical trials and FDA regulatory review.

 

Any delay in obtaining or failure to obtain required approvals could materially adversely affect our ability to generate revenues from the particular drug candidate. Furthermore, any regulatory approval to market a product may be subject to limitations on the indicated uses for which we may market the product. These limitations may limit the size of the market for the product. We are also subject to numerous foreign regulatory requirements governing the conduct of clinical trials, manufacturing and marketing authorization, pricing and third-party reimbursement. The foreign regulatory approval process includes all of the risks associated with FDA approval described above as well as risks attributable to the satisfaction of foreign regulations. Approval by the FDA does not ensure approval by regulatory authorities outside the United States. Foreign jurisdictions may have different approval procedures than those required by the FDA and may impose additional testing requirements for our drug candidates.

 

If clinical trials for our drug candidates are prolonged or delayed, we may be unable to commercialize our drug candidates on a timely basis, which would require us to incur additional costs and delay our receipt of any product revenue.

 

We cannot predict whether we will encounter problems with any of our completed, ongoing or planned clinical trials that will cause us or regulatory authorities to delay or suspend clinical trials, or delay the analysis of data from our completed or ongoing clinical trials. Any of the following could delay the clinical development of our drug candidates:

 

    ongoing discussions with the FDA or comparable foreign authorities regarding the scope or design of our clinical trials;

 

    delays in receiving, or the inability to obtain, required approvals from institutional review boards or other reviewing entities at clinical sites selected for participation in our clinical trials;

 

    delays in enrolling volunteers and patients into clinical trials;

 

    a lower than anticipated retention rate of volunteers and patients in clinical trials;

 

    the need to repeat clinical trials as a result of inconclusive or negative results or unforeseen complications in testing;

 

    inadequate supply or deficient quality of drug candidate materials or other materials necessary to conduct our clinical trials;

 

    unfavorable FDA inspection and review of a clinical trial site or records of any clinical or preclinical investigation;

 

    serious and unexpected drug-related side effects experienced by participants in our clinical trials; or

 

    the placement by the FDA of a clinical hold on a trial.

 

Our ability to enroll patients in our clinical trials in sufficient numbers and on a timely basis will be subject to a number of factors, including the size of the patient population, the nature of the protocol, the proximity of patients to clinical sites, the availability of effective treatments for the relevant disease and the eligibility criteria for the clinical trial. Delays in patient enrollment may result in increased costs and longer development times. For example, we are experiencing and may continue to experience delays in patient enrollment in connection with our phase II trial of elvucitabine in HIV infected patients who have failed a HAART regimen which included Epivir (3TC) due to the strict entry criteria for this trial. We are taking steps we believe will prevent future delays in the enrollment of this trial, including expanding the number of sites at which the trial will be conducted and changing the protocol of the trial to include additional treatment with elvucitabine after the initial 14 days of treatment. We cannot assure you that these actions will prevent further delays in patient enrollment in connection with this trial. In addition, subjects may drop out of our clinical trials, and thereby impair the validity or statistical significance of the trials.

 

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We, the FDA or other applicable regulatory authorities may suspend clinical trials of a drug candidate at any time if we or they believe the subjects or patients participating in such clinical trials are being exposed to unacceptable health risks or for other reasons.

 

We cannot predict whether any of our drug candidates will encounter problems during clinical trials which will cause us or regulatory authorities to delay or suspend these trials, or which will delay the analysis of data from these trials. In addition, it is impossible to predict whether legislative changes will be enacted, or whether FDA regulations, guidance or interpretations will be changed, or what the impact of such changes, if any, may be. If we experience any such problems, we may not have the financial resources to continue development of the drug candidate that is affected or the development of any of our other drug candidates.

 

Even if we obtain regulatory approvals, our drug candidates will be subject to ongoing regulatory review. If we fail to comply with continuing U.S. and applicable foreign regulations, we could lose those approvals, and our business would be seriously harmed.

 

Even if we receive regulatory approval of any drugs we are developing or may develop, we will be subject to continuing regulatory review, including the review of clinical results which are reported after our drug candidates become commercially available approved drugs. As greater numbers of patients use a drug following its approval, side effects and other problems may be observed after approval that were not seen or anticipated during pre-approval clinical trials. In addition, the manufacturer, and the manufacturing facilities we use to make any approved drugs, will also be subject to periodic review and inspection by the FDA. The subsequent discovery of previously unknown problems with the drug, manufacturer or facility may result in restrictions on the drug, manufacturer or facility, including withdrawal of the drug from the market. If we fail to comply with applicable continuing regulatory requirements, we may be subject to fines, suspension or withdrawal of regulatory approval, product recalls and seizures, operating restrictions and criminal prosecutions.

 

If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.

 

Our research and development efforts involve the controlled use of hazardous materials, chemicals and various radioactive compounds. Although we believe that our safety procedures for handling and disposing of these materials comply with the standards prescribed by state and federal regulations, the risk of accidental contamination or injury from these materials cannot be eliminated. If an accident occurs, we could be held liable for resulting damages, which could be substantial. We are also subject to numerous environmental, health and workplace safety laws and regulations, including those governing laboratory procedures, exposure to blood-borne pathogens and the handling of biohazardous materials. Additional federal, state and local laws and regulations affecting our operations may be adopted in the future. Although we maintain workers’ compensation insurance to cover us for costs we may incur due to injuries to our employees resulting from the use of these materials, this insurance may not provide adequate coverage against potential liabilities. Due to the small amount of hazardous materials that we generate, we have determined that the cost to secure insurance coverage for environmental liability and toxic tort claims far exceeds the benefits. Accordingly, we do not maintain any insurance to cover pollution conditions or other extraordinary or unanticipated events relating to our use and disposal of hazardous materials. We may incur substantial costs to comply with, and substantial fines or penalties if we violate, any of these laws or regulations.

 

Risks Related to Commercialization of Our Drug Candidates

 

If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our drug candidates, we may not generate product revenue.

 

We have no commercial products, and we do not currently have an organization for the sales and marketing of pharmaceutical products. In order to successfully commercialize any drugs that may be approved in the future by the FDA or comparable foreign regulatory authorities, we must build our sales and marketing

 

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capabilities or make arrangements with third parties to perform these services. For certain drug candidates in selected indications where we believe that an approved product could be commercialized by a specialty sales force in North America that calls on a limited but focused group of physicians, we intend to commercialize these products ourselves. However, in therapeutic indications that require a large sales force selling to a large and diverse prescribing population and for markets outside of North America, we plan to enter into arrangements with other companies for commercialization. For example, we have entered into an agreement with Gilead Sciences for the development and commercialization of ACH-806. If we are unable to establish adequate sales, marketing and distribution capabilities, whether independently or with third parties, we may not be able to generate product revenue and may not become profitable.

 

If physicians and patients do not accept our future drugs, we may be unable to generate significant revenue, if any.

 

Even if elvucitabine, ACH-806 and ACH-702, or any other drug candidates we may develop or acquire in the future, obtain regulatory approval, they may not gain market acceptance among physicians, health care payors, patients and the medical community. Physicians may elect not to recommend these drugs for a variety of reasons including:

 

    timing of market introduction of competitive drugs;

 

    lower demonstrated clinical safety and efficacy compared to other drugs;

 

    lack of cost-effectiveness;

 

    lack of availability of reimbursement from managed care plans and other third-party payors;

 

    convenience and ease of administration;

 

    prevalence and severity of adverse side effects;

 

    other potential advantages of alternative treatment methods; and

 

    ineffective marketing and distribution support.

 

If our approved drugs fail to achieve market acceptance, we would not be able to generate significant revenue.

 

If third-party payors do not adequately reimburse patients for any of our drug candidates that are approved for marketing, they might not be purchased or used, and our revenues and profits will not develop or increase.

 

Our revenues and profits will depend significantly upon the availability of adequate reimbursement for the use of any approved drug candidates from governmental and other third-party payors, both in the United States and in foreign markets. Reimbursement by a third party may depend upon a number of factors, including the third-party payor’s determination that use of a product is:

 

    a covered benefit under its health plan;

 

    safe, effective and medically necessary;

 

    appropriate for the specific patient;

 

    cost effective; and

 

    neither experimental nor investigational.

 

Obtaining reimbursement approval for a product from each third-party and government payor is a time-consuming and costly process that could require us to provide supporting scientific, clinical and cost-effectiveness data for the use of any approved drugs to each payor. We may not be able to provide data sufficient to gain acceptance with respect to reimbursement. There also exists substantial uncertainty concerning third-party reimbursement for the use of any drug candidate incorporating new technology, and even if determined eligible,

 

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coverage may be more limited than the purposes for which the drug is approved by the FDA. Moreover, eligibility for coverage does not imply that any drug will be reimbursed in all cases or at a rate that allows us to make a profit or even cover our costs. Interim payments for new products, if applicable, may also not be sufficient to cover our costs and may not be made permanent. Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may be based on payments allowed for lower-cost products that are already reimbursed, may be incorporated into existing payments for other products or services, and may reflect budgetary constraints and/or imperfections in Medicare or Medicaid data used to calculate these rates. Net prices for products may be reduced by mandatory discounts or rebates required by government health care programs or by any future relaxation of laws that restrict imports of certain medical products from countries where they may be sold at lower prices than in the United States.

 

There have been, and we expect that there will continue to be, federal and state proposals to constrain expenditures for medical products and services, which may affect payments for any of our approved products. The Centers for Medicare and Medicaid Services frequently change product descriptors, coverage policies, product and service codes, payment methodologies and reimbursement values. Third-party payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates and may have sufficient market power to demand significant price reductions. As a result of actions by these third-party payors, the health care industry is experiencing a trend toward containing or reducing costs through various means, including lowering reimbursement rates, limiting therapeutic class coverage and negotiating reduced payment schedules with service providers for drug products.

 

Our inability to promptly obtain coverage and profitable reimbursement rates from government-funded and private payors for any approved products could have a material adverse effect on our operating results and our overall financial condition.

 

Recent federal legislation will increase the pressure to reduce prices of pharmaceutical products paid for by Medicare, which could adversely affect our revenues, if any.

 

The Medicare Prescription Drug Improvement and Modernization Act of 2003, or MMA, changes the way Medicare will cover and pay for pharmaceutical products. The legislation expanded Medicare coverage for drug purchases by the elderly and eventually will introduce a new reimbursement methodology based on average sales prices for drugs. In addition, this legislation provides authority for limiting the number of drugs that will be covered in any therapeutic class. As a result of this legislation and the expansion of federal coverage of drug products, we expect that there will be additional pressure to contain and reduce costs. These cost reduction initiatives and other provisions of this legislation could decrease the coverage and price that we receive for any approved products and could seriously harm our business. While the MMA applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates, and any reduction in reimbursement that results from the MMA may result in a similar reduction in payments from private payors.

 

Risks Related to Our Dependence on Third Parties

 

We may not be able to execute our business strategy if we are unable to enter into alliances with other companies that can provide capabilities and funds for the development and commercialization of our drug candidates. If we are unsuccessful in forming or maintaining these alliances on favorable terms, our business may not succeed.

 

We have entered into a collaboration arrangement with Gilead Sciences for the development and commercialization of ACH-806 and, under certain circumstances, other HCV compounds with a similar mechanism of action, and we may enter into additional collaborative arrangements in the future. For example, we may enter into alliances with major biotechnology or pharmaceutical companies to jointly develop specific drug candidates and to jointly commercialize them if they are approved. In such alliances, we would expect our biotechnology or pharmaceutical collaborators to provide substantial funding, as well as significant capabilities

 

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in clinical development, regulatory affairs, marketing and sales. We may not be successful in entering into any such alliances on favorable terms, if at all. Even if we do succeed in securing such alliances, we may not be able to maintain them if, for example, development or approval of a drug candidate is delayed or sales of an approved drug are disappointing. Furthermore, any delay in entering into collaboration agreements could delay the development and commercialization of our drug candidates and reduce their competitiveness even if they reach the market. Any such delay related to our collaborations could adversely affect our business.

 

If a collaborative partner terminates or fails to perform its obligations under agreements with us, the development and commercialization of our drug candidates could be delayed or terminated.

 

If Gilead Sciences or another, future collaborative partner does not devote sufficient time and resources to collaboration arrangements with us, we may not realize the potential commercial benefits of the arrangement, and our results of operations may be adversely affected. In addition, if any existing or future collaboration partner were to breach or terminate its arrangements with us, the development and commercialization of the affected drug candidate could be delayed, curtailed or terminated because we may not have sufficient financial resources or capabilities to continue development and commercialization of the drug candidate on our own. Under our collaboration agreement with Gilead Sciences, Gilead Sciences may terminate the collaboration for any reason at any time upon 120 days notice after the earlier of (i) proof-of-concept of ACH-806 or (ii) November 24, 2006. If Gilead Sciences were to exercise this right, the development and commercialization of ACH-806 would be adversely affected.

 

Much of the potential revenue from our existing and future collaborations will consist of contingent payments, such as payments for achieving development milestones and royalties payable on sales of drugs developed. The milestone and royalty revenues that we may receive under these collaborations will depend upon our collaborator’s ability to successfully develop, introduce, market and sell new products. In addition, our collaborators may decide to enter into arrangements with third parties to commercialize products developed under our existing or future collaborations using our technologies, which could reduce the milestone and royalty revenue that we may receive, if any. In many cases we will not be involved in these processes and accordingly will depend entirely on our collaborators. Our collaboration partners may fail to develop or effectively commercialize products using our products or technologies because they:

 

    decide not to devote the necessary resources due to internal constraints, such as limited personnel with the requisite scientific expertise, limited cash resources or specialized equipment limitations, or the belief that other drug development programs may have a higher likelihood of obtaining regulatory approval or may potentially generate a greater return on investment;

 

    do not have sufficient resources necessary to carry the drug candidate through clinical development, regulatory approval and commercialization; or

 

    cannot obtain the necessary regulatory approvals.

 

In addition, a collaborator may decide to pursue a competitive drug candidate developed outside of the collaboration. In particular, Gilead Sciences, our collaborator for our chronic hepatitis C program, currently is developing other products for the treatment of chronic hepatitis C, and the results of its development efforts could affect its commitment to our drug candidate. If our collaboration partners fail to develop or effectively commercialize drug candidates or drugs for any of these reasons, we may not be able to replace the collaboration partner with another partner to develop and commercialize a drug candidate or drugs under the terms of the collaboration. We may also be unable to obtain, on terms acceptable to us, a license from such collaboration partner to any of its intellectual property that may be necessary or useful for us to continue to develop and commercialize a drug candidate.

 

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We rely on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily, including failing to meet established deadlines for the completion of such trials.

 

We do not have the ability to independently conduct clinical trials for our drug candidates, and we rely on third parties such as contract research organizations, medical institutions and clinical investigators to enroll qualified patients and conduct our clinical trials. Our reliance on these third parties for clinical development activities reduces our control over these activities. Accordingly, these third-party contractors may not complete activities on schedule, or may not conduct our clinical trials in accordance with regulatory requirements or our trial design. To date, we believe our contract research organizations and other similar entities with which we are working have performed well. However, if these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be required to replace them. Although we believe that there are a number of other third-party contractors we could engage to continue these activities, it may result in a delay of the affected trial. Accordingly, our efforts to obtain regulatory approvals for and commercialize our drug candidates may be delayed.

 

We currently depend on third-party manufacturers to produce our preclinical and clinical drug supplies and intend to rely upon third-party manufacturers to produce commercial supplies of any approved drug candidates. If in the future we manufacture any of our drug candidates, we will be required to incur significant costs and devote significant efforts to establish and maintain these capabilities.

 

We have relied upon third parties to produce material for preclinical and clinical testing purposes and intend to continue to do so in the future. We also expect to rely upon third parties to produce materials required for the commercial production of our drug candidates if we succeed in obtaining necessary regulatory approvals. If we are unable to arrange for third-party manufacturing, or to do so on commercially reasonable terms, we may not be able to complete development of our drug candidates or market them. Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured drug candidates ourselves, including reliance on the third party for regulatory compliance and quality assurance, the possibility of breach of the manufacturing agreement by the third party because of factors beyond our control and the possibility of termination or nonrenewal of the agreement by the third party, based on its own business priorities, at a time that is costly or damaging to us. In addition, the FDA and other regulatory authorities require that our drug candidates be manufactured according to current good manufacturing practice regulations. Any failure by us or our third-party manufacturers to comply with current good manufacturing practices and/or our failure to scale up our manufacturing processes could lead to a delay in, or failure to obtain, regulatory approval of any of our drug candidates. In addition, such failure could be the basis for action by the FDA to withdraw approvals for drug candidates previously granted to us and for other regulatory action.

 

We currently rely on a single manufacturer for the preclinical and clinical supplies of each of our drug candidates and do not currently have relationships for redundant supply or a second source for any of our drug candidates. To date, our third-party manufacturers have met our manufacturing requirements, but we cannot assure you that they will continue to do so. Any performance failure on the part of our existing or future manufacturers could delay clinical development or regulatory approval of our drug candidates or commercialization of any approved products. If for some reason our current contract manufacturers cannot perform as agreed, we may be required to replace them. Although we believe there are a number of potential replacements as our manufacturing processes are not manufacturer specific, we may incur added costs and delays in identifying and qualifying any such replacements. Furthermore, although we generally do not begin a clinical trial unless we believe we have a sufficient supply of a drug candidate to complete the trial, any significant delay in the supply of a drug candidate for an ongoing trial due to the need to replace a third-party manufacturer could delay completion of the trial.

 

We may in the future elect to manufacture certain of our drug candidates in our own manufacturing facilities. If we do so, we will require substantial additional funds and need to recruit qualified personnel in order to build or lease and operate any manufacturing facilities.

 

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Risks Related to Patents and Licenses

 

If we are unable to adequately protect our drug candidates, or if we infringe the rights of others, our ability to successfully commercialize our drug candidates will be harmed.

 

As of September 15, 2006, our patent portfolio included a total of 156 patents and patent applications worldwide. We own or hold exclusive licenses to a total of seven U.S. issued patents and 21 U.S. pending patent applications, as well as 122 pending PCT applications and foreign counterparts to many of these patents and patent applications. Our success depends in part on our ability to obtain patent protection both in the United States and in other countries for our drug candidates. Our ability to protect our drug candidates from unauthorized or infringing use by third parties depends in substantial part on our ability to obtain and maintain valid and enforceable patents. Due to evolving legal standards relating to the patentability, validity and enforceability of patents covering pharmaceutical inventions and the scope of claims made under these patents, our ability to maintain, obtain and enforce patents is uncertain and involves complex legal and factual questions. Accordingly, rights under any issued patents may not provide us with sufficient protection for our drug candidates or provide sufficient protection to afford us a commercial advantage against competitive products or processes. In addition, we cannot guarantee that any patents will issue from any pending or future patent applications owned by or licensed to us. Even if patents have issued or will issue, we cannot guarantee that the claims of these patents are or will be valid or enforceable or will provide us with any significant protection against competitive products or otherwise be commercially valuable to us. Patent applications in the United States are maintained in confidence for up to 18 months after their filing. In some cases, however, patent applications remain confidential in the U.S. Patent and Trademark Office, which we refer to as the U.S. Patent Office, for the entire time prior to issuance as a U.S. patent. Similarly, publication of discoveries in the scientific or patent literature often lag behind actual discoveries. Consequently, we cannot be certain that we or our licensors or co-owners were the first to invent, or the first to file patent applications on, our drug candidates or their use as anti-infective drugs. In the event that a third party has also filed a U.S. patent application relating to our drug candidates or a similar invention, we may have to participate in interference proceedings declared by the U.S. Patent Office to determine priority of invention in the United States. The costs of these proceedings could be substantial and it is possible that our efforts would be unsuccessful, resulting in a loss of our U.S. patent position. Furthermore, we may not have identified all U.S. and foreign patents or published applications that affect our business either by blocking our ability to commercialize our drugs or by covering similar technologies that affect our drug market.

 

The laws of some foreign jurisdictions do not protect intellectual property rights to the same extent as in the United States and many companies have encountered significant difficulties in protecting and defending such rights in foreign jurisdictions. If we encounter such difficulties in protecting or are otherwise precluded from effectively protecting our intellectual property rights in foreign jurisdictions, our business prospects could be substantially harmed.

 

We license patent rights from third-party owners. If such owners do not properly maintain or enforce the patents underlying such licenses, our competitive position and business prospects will be harmed.

 

We are party to a number of licenses that give us rights to third-party intellectual property that is necessary or useful for our business. In particular, we have obtained a sublicense from Vion Pharmaceuticals and a license from Emory University with respect to elvucitabine. We may enter into additional licenses to third-party intellectual property in the future. Our success will depend in part on the ability of our licensors to obtain, maintain and enforce patent protection for their intellectual property, in particular, those patents to which we have secured exclusive rights. Our licensors may not successfully prosecute the patent applications to which we are licensed. Even if patents issue in respect of these patent applications, our licensors may fail to maintain these patents, may determine not to pursue litigation against other companies that are infringing these patents, or may pursue such litigation less aggressively than we would. In addition, our licensors may terminate their agreements with us in the event we breach the applicable license agreement and fail to cure the breach within a specified period of time. Without protection for the intellectual property we license, other companies might be able to offer

 

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substantially identical products for sale, which could adversely affect our competitive business position and harm our business prospects.

 

Litigation regarding patents, patent applications and other proprietary rights may be expensive and time consuming. If we are involved in such litigation, it could cause delays in bringing drug candidates to market and harm our ability to operate.

 

Our success will depend in part on our ability to operate without infringing the proprietary rights of third parties. Although we are not currently aware of any litigation or other proceedings or third-party claims of intellectual property infringement related to our drug candidates, the pharmaceutical industry is characterized by extensive litigation regarding patents and other intellectual property rights. Other parties may obtain patents in the future and allege that the use of our technologies infringes these patent claims or that we are employing their proprietary technology without authorization. Likewise, third parties may challenge or infringe upon our existing or future patents. Under our license agreements with Vion Pharmaceuticals and The University of Maryland, we have the right, but not an obligation, to bring actions against an infringing third party. If we do not bring an action within a specified number of days, the licensor may bring an action against the infringing party. Pursuant to our license agreement with Emory University and our research collaboration and license agreement with Gilead Sciences, Emory and Gilead Sciences have the primary right, but not an obligation, to bring actions against an infringing third party. However, if Gilead Sciences or Emory elects not to bring an action, we may bring an action against the infringing party.

 

Proceedings involving our patents or patent applications or those of others could result in adverse decisions regarding:

 

    the patentability of our inventions relating to our drug candidates; and/or

 

    the enforceability, validity or scope of protection offered by our patents relating to our drug candidates.

 

Even if we are successful in these proceedings, we may incur substantial costs and divert management time and attention in pursuing these proceedings, which could have a material adverse effect on us. If we are unable to avoid infringing the patent rights of others, we may be required to seek a license, defend an infringement action or challenge the validity of the patents in court. Patent litigation is costly and time consuming. We may not have sufficient resources to bring these actions to a successful conclusion. In addition, if we do not obtain a license, develop or obtain non-infringing technology, fail to defend an infringement action successfully or have infringed patents declared invalid, we may:

 

    incur substantial monetary damages;

 

    encounter significant delays in bringing our drug candidates to market; and/or

 

    be precluded from participating in the manufacture, use or sale of our drug candidates or methods of treatment requiring licenses.

 

Confidentiality agreements with employees and others may not adequately prevent disclosure of trade secrets and other proprietary information and may not adequately protect our intellectual property.

 

We rely on trade secrets to protect our technology, especially where we do not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to protect. In order to protect our proprietary technology and processes, we also rely in part on confidentiality and intellectual property assignment agreements with our corporate partners, employees, consultants, outside scientific collaborators and sponsored researchers and other advisors. These agreements may not effectively prevent disclosure of confidential information nor result in the effective assignment to us of intellectual property, and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information or other breaches of the agreements. In addition, others may independently discover our trade secrets and proprietary information, and in such case we could not

 

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assert any trade secret rights against such party. Enforcing a claim that a party illegally obtained and is using our trade secrets is difficult, expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the United States may be less willing to protect trade secrets. Costly and time-consuming litigation could be necessary to seek to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect our competitive business position.

 

Risks Relating to Our Common Stock and this Offering

 

An active trading market for our common stock may not develop, and you may not be able to resell your shares at or above the initial public offering price.

 

Prior to this offering, there has been no public market for our common stock. Although we have applied to have our common stock approved for quotation on the NASDAQ Global Market, an active trading market for our shares may never develop or be sustained following this offering. The initial public offering price for our common stock will be determined through negotiations between us and the underwriters. This initial public offering price may not be indicative of the market price of our common stock after the offering. The market price of our stock may decline below the initial public offering price, and you may not be able to resell your shares at or above the initial public offering price.

 

Our stock price is likely to be volatile, and the market price of our common stock after this offering may drop below the price you pay.

 

The market price of our common stock could be subject to significant fluctuations after this offering, and may decline below the initial public offering price. You should consider an investment in our common stock as risky and invest only if you can withstand a significant loss and wide fluctuations in the market value of your investment. Market prices for securities of early stage pharmaceutical, biotechnology and other life sciences companies have historically been particularly volatile. As a result of this volatility, you may not be able to sell your common stock at or above the initial public offering price. Some of the factors that may cause the market price of our common stock to fluctuate include:

 

    the results of our current phase II and any future clinical trials for elvucitabine;

 

    the results of our current proof-of-concept and any future clinical trials for ACH-806;

 

    the results of ongoing preclinical studies and planned clinical trials of our preclinical drug candidates, including ACH-702;

 

    the entry into, or termination of, key agreements, in particular our collaboration agreement with Gilead Sciences or our sublicense agreement with Vion Pharmaceuticals;

 

    the results of regulatory reviews relating to the approval of our drug candidates;

 

    the initiation of, material developments in, or conclusion of litigation to enforce or defend any of our intellectual property rights;

 

    failure of any of our drug candidates, if approved, to achieve commercial success;

 

    general and industry-specific economic conditions that may affect our research and development expenditures;

 

    the results of clinical trials conducted by others on drugs that would compete with our drug candidates;

 

    the failure or discontinuation of any of our research programs;

 

    issues in manufacturing our drug candidates or any approved products;

 

    the introduction of technological innovations or new commercial products by us or our competitors;

 

    changes in estimates or recommendations by securities analysts, if any, who cover our common stock;

 

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    future sales of our common stock;

 

    changes in the structure of health care payment systems; and

 

    period-to-period fluctuations in our financial results.

 

The stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies. These broad market fluctuations may adversely affect the trading price of our common stock.

 

In the past, following periods of volatility in the market price of a company’s securities, stockholders have often instituted class action securities litigation against those companies. Such litigation, if instituted, could result in substantial costs and diversion of management attention and resources, which could significantly harm our profitability and reputation.

 

Management will have broad discretion in the use of the net proceeds from this offering and may not use them effectively or in a manner that is consistent with the uses described in the prospectus.

 

Although we intend to use the net proceeds of this offering to, among other things, finance working capital needs, including the continued development of elvucitabine, ACH-806 and ACH-702, as well as to fund continuing operations, because of the number and variability of factors that will determine our use of these proceeds, we cannot specify with certainty the particular uses of the net proceeds that we will receive from this offering. We will have broad discretion in the application of the net proceeds, including for any of the purposes described in “Use of Proceeds” on page 25 of this prospectus. However, our plans may change, and we could use the net proceeds in ways with which stockholders do not agree, or for corporate purposes that may not result in a significant or any return on your investment. In addition, we may invest the net proceeds from this offering in a manner that does not produce income or that loses value.

 

If you purchase our common stock in this offering, you will experience immediate and substantial dilution in the book value of your shares.

 

The assumed initial public offering price is substantially higher than the net tangible book value per share of our common stock. As a result, investors purchasing common stock in this offering will incur immediate dilution of $10.36 per share, based on an assumed initial public offering price of $15.00 per share, the midpoint of the price range set forth on the cover page of this prospectus. Further, investors purchasing common stock in this offering will contribute approximately 40% of the total amount invested by stockholders since our inception, but will own only approximately 30% of the shares of common stock outstanding.

 

This dilution is due to our existing investors having purchased shares prior to this offering for substantially less than the price offered to the public in this offering, as well as the exercise of stock options granted to our employees with exercise prices lower than the price offered to the public in this offering. As of September 15, 2006, options to purchase 807,548 shares of common stock at a weighted average exercise price of $2.28 per share were outstanding, and warrants to purchase 335,739 shares of our common stock, with an exercise price of $6.08, were outstanding. The exercise of any of these options or warrants would result in additional dilution. As a result of this dilution, investors purchasing stock in this offering may receive significantly less than the purchase price paid in this offering in the event of liquidation.

 

Our executive officers, directors and principal stockholders own a large percentage of our voting common stock and could limit new stockholders’ influence on corporate decisions or could delay or prevent a change in corporate control.

 

After this offering, our directors, executive officers and current holders of more than 5% of our outstanding common stock, together with their affiliates and related persons, will beneficially own, in the

 

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aggregate, approximately 63% of our outstanding common stock, or 61% if the underwriters exercise their overallotment option in full. As a result, these stockholders, if acting together, will have the ability to determine the outcome of all matters submitted to our stockholders for approval, including the election and removal of directors and any merger, consolidation or sale of all or substantially all of our assets and other extraordinary transactions. The interests of this group of stockholders may not always coincide with our corporate interests or the interest of other stockholders, and they may act in a manner with which you may not agree or that may not be in the best interests of other stockholders. This concentration of ownership may have the effect of:

 

    delaying, deferring or preventing a change in control of our company;

 

    entrenching our management and/or board;

 

    impeding a merger, consolidation, takeover or other business combination involving our company; or

 

    discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of our company.

 

Anti-takeover provisions in our certificate of incorporation and bylaws and under Delaware law could make our acquisition by another company more difficult and may prevent attempts by our stockholders to replace or remove our current management.

 

Provisions in our certificate of incorporation and our bylaws that will become effective upon the completion of this offering may delay or prevent our acquisition by another company. In addition, these provisions may frustrate or prevent attempts by our stockholders to replace or remove members of our board of directors. Because our board of directors is responsible for appointing the members of our management team, these provisions could in turn affect any attempt by our stockholders to replace current members of our management team. These provisions include:

 

    a classified board of directors;

 

    a prohibition on actions by our stockholders by written consent and limitations on who may call stockholder meetings;

 

    the ability of our board of directors to issue preferred stock without stockholder approval, which could be used to institute a “poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our board of directors;

 

    limitations on the removal of directors;

 

    a supermajority stockholder vote requirement to amend certain provisions of our certificate of incorporation and our bylaws;

 

    advance notice requirements for nominations of directors or stockholder proposals; and

 

    the requirement that board vacancies be filled by a majority of our directors then in office.

 

Our certificate of incorporation and our bylaws that will become effective upon the completion of this offering also provide that directors may be removed only for cause and only by the affirmative vote of the holders of at least 75% or more of our outstanding voting stock. In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining with us for a period of three years after the date of the transaction in which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner. These provisions would apply even if the offer may be considered beneficial by some stockholders.

 

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If there are substantial sales of our common stock in the market by our existing stockholders, our stock price could decline.

 

If our existing stockholders sell a large number of shares of our common stock or the public market perceives that existing stockholders might sell shares of common stock, the market price of our common stock could decline significantly. After this offering, we will have outstanding 14,830,391 shares of common stock based on the number of shares outstanding as of September 15, 2006. This includes the 4,500,000 shares that we are selling in this offering, which may be immediately resold in the public market without restriction, unless those shares are purchased by our affiliates. Any shares purchased by our affiliates in this offering may only be sold in compliance with the volume limitations of Rule 144. These volume limitations restrict the number of shares that may be sold by an affiliate in any three-month period to the greater of 1% of the number of shares then outstanding, which will equal approximately 148,304 shares immediately after this offering based on the number of shares outstanding as of September 15, 2006, or the average weekly trading volume of our common stock during the four calendar weeks preceding the filing of a notice on Form 144 with respect to the sale. The remaining 10,330,391 shares not issued in this offering, or 69.7% of our outstanding shares after this offering, are currently restricted as a result of securities laws or lock-up agreements but will be able to be sold in the near future as set forth below:

 

Number of Shares


 

Date


269,062

  On the date of this prospectus.

325,609

  After 90 days from the date of this prospectus.

8,550,395

  After 180 days* from the date of this prospectus (subject, in some cases, to volume limitations).

1,185,325

  At various times after 180 days* from the date of this prospectus (subject, in some cases, to volume limitations).

* 180 days corresponds to the end of the lock-up period described in “Shares Eligible for Future Sale—Lock-up Agreements” on page 96 of this prospectus. This lock-up period may be extended or shortened under certain circumstances as described in that section. However, Cowen and Company, LLC may in its sole discretion, at any time without prior notice, release all or any portion of the shares from the restrictions in any of these agreements. In considering any request to release shares from a lock-up agreement, Cowen and Company, LLC will consider the facts and circumstances relating to a request at the time of the request.

 

Subject to certain conditions, after the lock-up period, holders of an aggregate of approximately 9,815,718 shares of common stock will have rights with respect to the registration of these shares of common stock with the Securities and Exchange Commission, or SEC. If we register their shares of common stock following the expiration of the lock-up agreements, they can sell those shares in the public market.

 

Promptly following this offering, we intend to register approximately 1,807,548 shares of common stock that are authorized for issuance under our 2006 stock incentive plan, employee stock purchase plan and outstanding stock options. As of September 15, 2006, 807,548 shares were subject to outstanding options. Once we register the shares authorized for issuance under our stock plans, they can be freely sold in the public market upon issuance, subject to the lock-up agreements referred to above and the restrictions imposed on our affiliates under Rule 144.

 

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We do not anticipate paying cash dividends, and accordingly stockholders must rely on stock appreciation for any return on their investment in us.

 

We anticipate that we will retain our earnings, if any, for future growth and therefore do not anticipate paying cash dividends in the future. As a result, only appreciation of the price of our common stock will provide a return to investors in this offering. Investors seeking cash dividends should not invest in our common stock.

 

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This prospectus contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical fact, included in this prospectus regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects and plans and objectives of management are forward-looking statements. The words “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements assume our ability to continue as a going concern. Forward-looking statements contained in this prospectus include, but are not limited to, statements about:

 

    our discussion of current and future markets for our drug candidates and our ability to address those markets, including our belief that substantial opportunities exist for improved treatments for HIV infection, chronic hepatitis C and bacterial infections;

 

    our research, development and commercialization activities and projected expenditures;

 

    our ability to obtain and maintain collaborators for some of our development programs;

 

    the receipt of regulatory approvals;

 

    the timing of clinical trials for our drug candidates;

 

    the completion and success of clinical trials for our drug candidates;

 

    future statistical information concerning the markets in which we expect our drug candidates to compete, if approved;

 

    our ability to protect our intellectual property rights in our drug candidates and operate our business without infringing upon the intellectual property rights of others;

 

    our spending of the proceeds from this offering;

 

    our cash needs;

 

    our estimates regarding the sufficiency of our cash resources; and

 

    our financial performance.

 

We have based these forward-looking statements on our current expectations and projections about future events. Although we believe that the expectations underlying any of our forward-looking statements are reasonable, these expectations may prove to be incorrect, and all of these statements are subject to risks and uncertainties. Therefore, you should not place undue reliance on our forward-looking statements. We have included important risks and uncertainties in the cautionary statements included in this prospectus, particularly in the section entitled “Risk Factors” beginning on page 6, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Should one or more of these risks and uncertainties materialize, or should underlying assumptions, projections or expectations prove incorrect, actual results, performance or financial condition may vary materially and adversely from those anticipated, estimated or expected. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

 

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USE OF PROCEEDS

 

We estimate that we will receive net proceeds from this offering of approximately $61.1 million, assuming an initial public offering price of $15.00 per share, the midpoint of the price range set forth on the cover of this prospectus, and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us. If the underwriters’ overallotment option is exercised in full, we estimate our net proceeds will be approximately $70.5 million.

 

We expect to use the majority of the net proceeds of this offering as follows:

 

    approximately $26.3 million to complete the current phase II clinical trials of elvucitabine and to further its clinical development into phase III clinical trials, including approximately $3.7 million of external costs related to current phase II clinical trials.

 

    approximately $3.2 million to support our share of ACH-806 development costs pursuant to our collaboration with Gilead Sciences through the proof-of-concept stage;

 

    approximately $1.5 million to complete the preclinical development of ACH-702, followed by approximately $11.5 million to fund further clinical development of ACH-702; and

 

    approximately $9.3 million to support research activities over the next 12 months on other HIV, chronic hepatitis C and antibacterial drug candidates.

 

We anticipate using the remaining $9.3 million of the net proceeds of this offering:

 

    to expand our other research and development programs to identify additional drug candidates for the treatment of HIV infection, chronic hepatitis C and bacterial infections; and

 

    to fund working capital, make capital expenditures, hire additional personnel necessary for operating as a public company and other general corporate purposes.

 

This foregoing use of net proceeds of this offering represents our current intentions based upon our present plans and business condition. The amounts and timing of our actual expenditures depend on numerous factors, including the amount of proceeds actually raised in this offering, the progress of our clinical trials and research and development efforts and our ability to enter into strategic collaborations, as well as the amount of cash used in our operations. Accordingly, our management will have broad discretion in the application of the proceeds of this offering. We do not expect the net proceeds from this offering and our other available funds to be sufficient to fund the completion of the development of any of our drug candidates, and we expect that we will need to raise additional funds prior to being able to market any drugs. In particular, to complete two phase III clinical trials for elvucitabine, we believe we may need to raise at least an additional $35.0 million.

 

We reserve the right to change the use of these proceeds as a result of certain contingencies such as the results of our drug discovery and development activities, competitive developments, opportunities to acquire products, technologies or businesses and other factors.

 

Pending the uses described above, we plan to invest the net proceeds of this offering in short and intermediate-term, interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the U.S. government.

 

We believe that the net proceeds from this offering, together with interest thereon and our existing cash and cash equivalents, as supplemented by research funding pursuant to our collaboration with Gilead Sciences, will be sufficient to meet our projected operating requirements into the third quarter of 2008. We will need to raise substantial additional funds before we can expect to commercialize any drug candidate. We expect to satisfy our future cash needs through the sale of equity securities, debt financings, corporate collaborations and licensing agreements and grant funding, as well as through interest income earned on cash balances.

 

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DIVIDEND POLICY

 

We have never declared or paid any dividends on our common stock. We currently intend to retain any future earnings to finance our research and development efforts, the development of our drug candidates and the expansion of our business and do not intend to declare or pay cash dividends on our capital stock in the foreseeable future. Any future determination to pay dividends will be at the discretion of our board of directors and will depend upon a number of factors, including our results of operations, financial condition, future prospects, contractual restrictions, restrictions imposed by applicable law and other factors our board of directors deems relevant.

 

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CAPITALIZATION

 

The following table sets forth our capitalization as of June 30, 2006:

 

    on an actual basis;

 

    on a pro forma basis to give effect to (i) the issuance of 8,584,356 shares of convertible preferred stock upon the closing of this offering in satisfaction of accumulated dividends on our series B, series C, series C-1 and series C-2 convertible preferred stock and the related incremental charge to retained deficit of $2.6 million to account for the difference between the stated dividend rate and the fair value of the preferred stock issued in satisfaction of the accrued but unpaid dividends, assuming the closing of this offering occurs on October 16, 2006 and (ii) the automatic conversion of all of our shares of convertible preferred stock outstanding as of June 30, 2006, including shares issued in satisfaction of such accumulated dividends, into 9,815,718 shares of common stock upon completion of this offering; and

 

    on a pro forma as adjusted basis to give effect to the receipt of net proceeds of $61.1 million from the sale of the 4,500,000 shares of common stock in this offering at an assumed initial public offering price of $15.00 per share, less underwriting discounts and commissions and estimated offering expenses payable by us.

 

You should read this information together with our financial statements and the related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” appearing elsewhere in this prospectus.

 

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     As of June 30, 2006

 

$ in thousands, except per share data


   Actual

    Pro
Forma


    Pro Forma
As Adjusted


 
     (unaudited)  
     (in thousands)  

Cash, cash equivalents and marketable securities

   $ 20,214     $ 20,214     $ 81,289  
    


 


 


Long-term debt, including current portion

     10,200       10,200       10,200  
    


 


 


Redeemable, Convertible Preferred Stock:

                        

Series A preferred stock, $.01 par value; 250 shares authorized actual and 0 shares authorized pro forma and pro forma as adjusted, 250 issued and outstanding actual and 0 shares issued and outstanding pro forma and pro forma as adjusted (liquidation preference of $250 at June 30, 2006)

     250       —         —    

Series B preferred stock, $.01 par value; 15,817 shares authorized actual and 0 shares authorized pro forma and pro forma as adjusted, 15,817 issued and outstanding actual and 0 shares issued and outstanding pro forma and pro forma as adjusted (liquidation preference of $28,442 at June 30, 2006)

     28,367       —         —    

Series C preferred stock, $.01 par value; 22,436 shares authorized actual and 0 shares authorized pro forma and pro forma as adjusted, 22,418 issued and outstanding actual and 0 shares issued and outstanding pro forma and pro forma as adjusted (liquidation preference of $48,069 at June 30, 2006)

     47,940       —         —    

Series C-1 preferred stock, $.01 par value; 2,300 shares authorized actual and 0 shares authorized pro forma and pro forma as adjusted, 2,300 issued and outstanding actual and 0 shares issued and outstanding pro forma and pro forma as adjusted (liquidation preference of $5,316 at June 30, 2006)

     2,341       —         —    

Series C-2 preferred stock, $.01 par value; 24,000 shares authorized actual and 0 shares authorized pro forma and pro forma as adjusted, 23,425 shares issued and outstanding actual and 0 shares issued and outstanding pro forma and pro forma as adjusted (liquidation preference of $72,411 at June 30, 2006)

     35,966       —         —    
    


 


 


       114,864       —         —    
    


 


 


Stockholders’ equity (deficit):

                        

Preferred stock, $0.01 par value; 0 shares authorized actual and pro forma and 5,000 shares authorized pro forma as adjusted; 0 shares outstanding actual, pro forma and pro forma as adjusted

     —         —         —    

Common stock, $.001 par value; 90,000 shares authorized actual; 95,000 shares authorized pro forma, and 100,000 shares authorized pro forma as adjusted; 515 shares issued and outstanding actual, 10,330 shares issued and outstanding pro forma and 14,830 shares issued and outstanding pro forma as adjusted, respectively

     4       10       15  

Additional paid-in capital

     —         117,427       178,497  

Stock warrants

     341       341       341  

Stock subscription receivable

     (114 )     (114 )     (114 )

Retained deficit

     (107,270 )     (109,839 )     (109,839 )

Unrealized gain on marketable securities

     4       4       4  
    


 


 


Total stockholders’ (deficit) equity

     (107,035 )     7,829       68,904  
    


 


 


Total capitalization

   $ 18,029     $ 18,029     $ 79,104  
    


 


 


 

The number of shares of our common stock, as reflected in the table above, is based on 514,673 shares of our common stock outstanding as of June 30, 2006, and excludes:

 

    828,729 shares of common stock issuable upon the exercise of stock options outstanding as of June 30, 2006, with a weighted average exercise price of $2.26 per share;

 

    335,739 shares of common stock issuable upon exercise of outstanding warrants as of June 30, 2006, with a weighted average exercise price of $6.08 per share; and

 

    an additional 35,358 shares of common stock reserved as of June 30, 2006 for future stock option grants and purchases under our 1998 stock option plan and an aggregate of 1,000,000 shares of common stock to be reserved for future stock option grants and purchases under our 2006 stock incentive plan and employee stock purchase plan.

 

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DILUTION

 

If you invest in our common stock, your interest will be immediately diluted to the extent of the difference between the public offering price per share of our common stock and the pro forma net tangible book value per share of our common stock after this offering. Historical net tangible book value per share represents our total tangible assets less total liabilities divided by the number of common shares outstanding as of June 30, 2006. The pro forma net tangible book value of our common stock as of June 30, 2006 was $7.8 million, or approximately $0.75 per share. Pro forma net tangible book value per share represents our June 30, 2006 total tangible assets less total liabilities divided by 10,330,391 shares of common stock outstanding at that date, after giving effect to the assumed issuance of 8,584,356 shares of convertible preferred stock upon the closing of this offering in satisfaction of accumulated dividends on our series B, series C, series C-1 and series C-2 convertible preferred stock (assuming for this purpose that the closing of the offering occurs on October 16, 2006) and the conversion of all outstanding shares of our convertible preferred stock into common stock.

 

Pro forma net tangible book value dilution per share to new investors represents the difference between the amount per share paid by purchasers of common stock in this offering and the pro forma as adjusted net tangible book value per share of common stock immediately after completion of this offering. After giving effect to our sale of 4,500,000 shares of common stock in this offering, after deducting estimated underwriting discounts and commissions and offering expenses, assuming an initial public offering price of $15.00 per share, our pro forma as adjusted net tangible book value as of June 30, 2006 would have been $68.8 million, or approximately $4.64 per share. This represents an immediate increase in pro forma net tangible book value of $3.89 per share to existing stockholders and an immediate dilution in pro forma net tangible book value of $10.36 per share to purchasers of common stock in this offering, as illustrated in the following table:

 

Assumed initial public offering price per share

         $ 15.00

Historical net tangible book value per share as of June 30, 2006

   15.08        

Decrease per share attributable to issuance of common shares in satisfaction of convertible preferred stock and related accrued dividends

   (14.33 )      
    

     

Pro forma net tangible book value per share before this offering

   0.75        

Pro forma increase per share attributable to new investors

   3.89        

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

           4.64
          

Pro forma dilution per share to new investors

         $ 10.36
          

 

Assuming the exercise in full of the underwriters’ overallotment option, our pro forma as adjusted net tangible book value at June 30, 2006 would have been approximately $5.05 per share, representing an immediate increase in the pro forma net tangible book value of $4.30 per share to our existing stockholders and an immediate dilution in pro forma net tangible book value of $9.95 per share to new investors.

 

The following table summarizes, on a pro forma basis, as of June 30, 2006, the difference between the number of shares of common stock purchased from us, assuming the issuance of 8,584,356 shares of convertible preferred stock upon the closing of this offering in satisfaction of accumulated dividends on our series B, series C, series C-1 and series C-2 convertible preferred stock (assuming for this purpose that the closing of the offering occurs on October 16, 2006) and the conversion of all outstanding shares of our convertible preferred stock into common stock, the total consideration paid to us and the average price per share paid by existing stockholders and by new investors in this offering at an assumed initial public offering price of $15.00 per share, before deducting underwriting discounts and estimated offering expenses.

 

     Shares Purchased

    Total Consideration

    Average Price
Per Share


     Number

   %

    Amount

   %

   

Existing stockholders

   10,330,391    70 %   101,718,000    60 %   $ 9.85

New investors

   4,500,000    30 %   67,500,000    40 %   $ 15.00
    
  

 
  

     

Total

   14,830,391    100 %   169,218,000    100 %      
    
  

 
  

     

 

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Assuming the underwriters’ overallotment option is exercised in full, sales by us in this offering will reduce the percentage of shares held by existing stockholders to 67% and will increase the number of shares held by new investors to 5,175,000, or 33%.

 

This information is based on 514,673 shares of our common stock outstanding as of June 30, 2006 and excludes:

 

    828,729 shares of common stock issuable upon the exercise of stock options outstanding as of June 30, 2006, with a weighted average exercise price of $2.26 per share;

 

    335,739 shares of common stock issuable upon exercise of outstanding warrants as of June 30, 2006, with a weighted average exercise price of $6.08 per share; and

 

    an additional 35,358 shares of common stock reserved as of June 30, 2006 for future stock option grants and purchases under our 1998 stock option plan and an aggregate of 1,000,000 shares of common stock to be reserved for future stock option grants and purchases under our 2006 stock incentive plan and employee stock purchase plan.

 

To the extent these outstanding options or warrants are exercised, there will be further dilution to the new investors.

 

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SELECTED FINANCIAL DATA

 

The following tables summarize our financial data for the periods presented. The selected statements of operations data for the fiscal years ended December 31, 2003, 2004 and 2005 and the selected balance sheet data as of December 31, 2004 and 2005 have been derived from financial statements audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, which appear elsewhere in this prospectus. The report of PricewaterhouseCoopers LLP, which also appears herein, contains an explanatory paragraph relating to the removal of an explanatory paragraph relating to our ability to continue as a going concern. The selected statements of operations data for the years ended December 31, 2001 and 2002, and the balance sheet data at December 31, 2001, 2002 and 2003 are derived from audited financial statements not included in this prospectus. The selected financial data as of June 30, 2006 and for the periods ended June 30, 2005 and June 30, 2006 are derived from our condensed unaudited financial statements. The condensed unaudited financial statements have been prepared on the same basis as our audited financial statements and include, in the opinion of management, all adjustments, consisting of only normal recurring adjustments, that management considers necessary for the fair statement of the financial information set forth in those statements. Historical results are not necessarily indicative of the results to be expected in future periods.

 

The selected financial data presented below should be read in conjunction with the more detailed information contained in the financial statements and notes thereto and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” appearing elsewhere in this prospectus.

 

     Years Ended December 31,

    Six Months
Ended June 30,


 
     2001

    2002

    2003

    2004

    2005

    2005

    2006

 
           (unaudited)  
     (in thousands, except per share data)  

Statement of Operations Data:

                                                        

Total operating revenue

   $ —       $ —       $ —       $ 807     $ 8,526     $ 4,865     $ 4,318  

Research and development

     9,658       16,670       13,194       14,841       18,112       9,415       10,969  

General and administrative

     3,073       4,824       3,261       3,181       3,101       1,619       2,216  

Total operating expenses

     12,731       21,494       16,455       18,022       21,213       11,034       13,185  

Net loss

     (11,649 )     (21,042 )     (15,754 )     (17,460 )     (13,575 )     (6,628 )     (8,996 )

Net loss applicable to common shareholders

   $ (12,153 )   $ (23,597 )   $ (18,326 )   $ (20,048 )   $ (16,514 )   $ (8,014 )   $ (11,282 )

Net loss per share—basic and diluted

   $ (57.60 )   $ (70.86 )   $ (44.16 )   $ (43.77 )   $ (32.96 )   $ (16.16 )   $ (22.08 )

Weighted average number of shares outstanding—basic and diluted

     211       333       415       458       501       496       511  
     As of December 31,

    As of June 30,

 
     2001

    2002

    2003

    2004

    2005

    2006

 
           (unaudited)  
     (in thousands, except per share data)  

Balance Sheet Data:

                                                        

Cash, cash equivalents and marketable securities

   $ 41,054     $ 25,784     $ 9,992     $ 14,378     $ 9,583       $  20,214  

Working capital

     39,676       23,815       8,393       6,264       654           13,142  

Total assets

     45,981       32,165       16,072       19,291       13,750           25,444  

Long-term liabilities

     1,780       3,390       3,046       14,811       5,021             7,605  

Total liabilities

     4,242       6,293       5,916       24,230       15,418           17,615  

Convertible preferred stock

     59,900       67,555       70,127       74,740       94,354         114,864  

Total stockholders’ (deficit)

     (18,161 )     (41,683 )     (59,971 )     (79,679 )     (96,022 )     (107,035)  

 

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF

FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and related notes appearing elsewhere in this prospectus. Some of the information contained in this discussion and analysis or set forth elsewhere in this prospectus, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. You should review the “Risk Factors” section beginning on page 6 of this prospectus for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

 

Overview

 

We are a biopharmaceutical company focused on the discovery, development and commercialization of innovative treatments for infectious diseases. Within the anti-infective market, we are currently concentrating on the development of antivirals and antibacterials. We are targeting our antiviral development efforts on treatments for HIV infection and chronic hepatitis C, and we are directing our antibacterial development efforts toward treatments for serious hospital-based bacterial infections.

 

We have devoted and are continuing to devote substantially all of our efforts toward product research and development. We have incurred losses of $94.8 million from inception to June 30, 2006 and had an accumulated deficit of $107.3 million through June 30, 2006. Our net losses were $15.8 million, $17.5 million and $13.6 million for the years ended December 31, 2003, 2004 and 2005, respectively, and $9.0 million for the six months ended June 30, 2006. We have funded our operations to date primarily through:

 

    proceeds of $101.8 million from the sale of equity securities;

 

    borrowings of $15.5 million from debt facilities; and

 

    receipts of $10.0 million from up-front and milestone payments, as well as $5.2 million in cost-sharing receipts, from our collaboration partner, Gilead Sciences.

 

We expect to incur substantial and increasing losses for at least the next several years as we seek to:

 

    complete our phase II clinical trials for elvucitabine and, if supported by favorable data from the phase II trials, initiate phase III clinical trials;

 

    complete our proof-of-concept clinical trial for ACH-806 (also known as GS 9132);

 

    advance ACH-702 through preclinical testing, submit an IND to the FDA and begin a phase I clinical trial; and

 

    continue to advance our other research and development programs in HIV and HCV and identify additional drug candidates.

 

We will need substantial additional financing to obtain regulatory approvals, fund operating losses, and, if deemed appropriate, establish manufacturing and sales and marketing capabilities, which we will seek to raise through public or private equity or debt financings, collaborative or other arrangements with third parties or through other sources of financing. There can be no assurance that such funds will be available on terms favorable to us, if at all. In addition to the normal risks associated with early-stage companies, there can be no assurance that we will successfully complete our research and development, obtain adequate patent protection for our technology, obtain necessary government regulatory approval for drug candidates we develop or that any approved drug candidates will be commercially viable. In addition, we may not be profitable even if we succeed in commercializing any of our drug candidates.

 

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Financial Operations Overview

 

Revenue

 

To date, we have not generated any revenue from the sale of any drugs. The majority of our revenue recognized to date has been derived from our collaboration with Gilead Sciences to develop compounds for use in treating chronic hepatitis C. Through June 30, 2006, we have recognized approximately $13.2 million in revenue from our collaboration with Gilead Sciences.

 

Upon initiating our collaboration with Gilead Sciences, we received a payment of $10.0 million, which included an equity investment by Gilead Sciences determined to be worth approximately $2.0 million. The remaining $8.0 million is being accounted for as a nonrefundable up-front fee recognized under the proportionate performance model. Revenue under the proportionate performance model is recognized as our effort under the collaboration is incurred. When our performance obligation is complete, we will recognize milestone payments, if any, when the corresponding milestone is achieved. We will recognize royalty payments, if any, upon product sales.

 

Research and development expenses under our collaboration with Gilead Sciences, including internal full-time equivalent costs and external research costs, incurred by both companies prior to proof-of-concept, are borne equally by both parties. As we are providing the majority of those services and are incurring the majority of those expenses, we are the net recipient of funds under this cost-sharing portion of the arrangement and therefore recognize the reimbursed costs as revenue rather than research expense. Payments made by us to Gilead Sciences in connection with this collaboration are being recognized as a reduction of revenue.

 

We have also recognized revenue under a Small Business Innovation Research, or SBIR, grant by the National Institutes of Health, or NIH, related to our HIV capsid research program. Through June 30, 2006, we have recognized approximately $406,000 in revenue under this grant.

 

Research and Development

 

Our research and development expenses reflect costs incurred for our proprietary research and development projects as well as costs for research and development projects conducted as part of collaborative arrangements we establish. These costs consist primarily of salaries and benefits for our research and development personnel, costs of services by clinical research organizations, other outsourced research, materials used during research and development activities, facility-related costs such as rent and utilities associated with our laboratory and clinical development space, operating supplies and other costs associated with our research and development activities. We expect research and development costs to increase significantly over the next several years as our drug development programs progress.

 

All costs associated with internal research and development, and research and development services for which we have externally contracted, are expensed as incurred. Our research and development expenses are outlined in the table below.

 

     Years Ended December 31,

  

Six

Months Ended
June 30,


     2003

   2004

   2005

   2005

   2006

     (in thousands)

Direct external costs:

                                  

Elvucitabine

   $ 1,927    $ 1,550    $ 2,520    $ 1,215    $ 2,609

ACH-806

     404      2,277      4,047      2,523      2,034

ACH-702

     248      530      1,025      491      919
    

  

  

  

  

       2,579      4,357      7,592      4,229      5,562

Direct internal personnel costs

     5,482      5,108      5,301      2,600      3,028
    

  

  

  

  

Sub-total direct costs

     8,061      9,465      12,893      6,829      8,590

Indirect costs and overhead

     5,133      5,376      5,219      2,586      2,379
    

  

  

  

  

Total research and development

   $ 13,194    $ 14,841    $ 18,112    $ 9,415    $ 10,969
    

  

  

  

  

 

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Currently, we are conducting two phase II clinical trials for elvucitabine, a proof-of-concept clinical trial for ACH-806 and preclinical studies for ACH-702. From the inception of each respective program through June 30, 2006, we incurred approximately $28.6 million in total costs for elvucitabine, approximately $18.3 million in total costs for ACH-806 and approximately $10.0 million in total costs for ACH-702. These figures include our internal research and development personnel costs and related facilities overhead. We expect our research and development costs to increase substantially in the foreseeable future. We currently estimate that the clinical trial costs for two phase III clinical trials of elvucitabine in different HIV populations, which we expect to begin in 2007, will be approximately $48.0 million, exclusive of the internal personnel costs associated with conducting these trials. We anticipate that our costs associated with ACH-806 will cease after the first quarter of 2007 after completion of our proof-of-concept trial under our collaboration with Gilead Sciences. We estimate that the costs associated with completing preclinical studies and phase I clinical trials for ACH-702, which we expect to complete in 2007, will be approximately $3.0 million, exclusive of the internal personnel costs associated with conducting these studies and trials.

 

The successful development of our drug candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the remainder of the development of our drug candidates. We are also unable to predict when, if ever, material net cash inflows will commence from elvucitabine, ACH-806, ACH-702 or any early stage programs. This is due to the numerous risks and uncertainties associated with developing drugs, including the uncertainty of:

 

    the scope, rate of progress and expense of our clinical trials and other research and development activities;

 

    the potential benefits of our drug candidates over other therapies;

 

    in the case of ACH-806, the rate at which our collaboration partner, Gilead Sciences, is able to complete later phase II and phase III clinical trials, and the degree to which Gilead Sciences prioritizes those trials over its other development efforts;

 

    our ability to market, commercialize and achieve market acceptance for any of our drug candidates that we are developing or may develop in the future;

 

    future clinical trial results;

 

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

 

    the expense and timing of regulatory approvals; and

 

    the expense of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights.

 

A change in the outcome of any of these variables with respect to the development of any of our drug candidates would significantly change the costs and timing associated with the development of that drug candidate. For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those which we currently anticipate will be required to complete clinical development of a drug candidate, or if we experience significant delays in enrollment in any of our clinical trials, we would be required to expend significant additional financial resources and time on the completion of clinical development.

 

We expect expenses associated with the completion of these programs to be substantial and increase. We do not believe, however, that it is possible at this time to accurately project total program-specific expenses through commercialization. There exist numerous factors associated with the successful commercialization of any of our drug candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. Additionally, future commercial and regulatory factors beyond our control will evolve and therefore impact our clinical development programs and plans over time.

 

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General and Administrative

 

Our general and administrative expenses consist primarily of salaries and benefits for management and administrative personnel, professional fees for legal, accounting and other services, travel costs and facility-related costs such as rent, utilities and other general office expenses. We expect our general and administrative expenses to increase as we continue to hire additional employees, increase our recruiting efforts, expand our infrastructure and incur additional costs related to the growth of our business and operations as a public company.

 

Critical Accounting Policies

 

The discussion and analysis of our financial condition and results of operations set forth below are based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, we evaluate our estimates and assumptions, including those described below. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Management makes estimates and exercises judgment in revenue recognition, research and development costs, stock-based compensation and accrued expenses. Actual results may differ from these estimates under different assumptions or conditions.

 

We believe the following critical accounting policies affect management’s more significant judgments and estimates used in the preparation of our financial statements:

 

Revenue Recognition

 

We recognize revenue from contract research and development and research progress payments in accordance with Staff Accounting Bulletin, or SAB, No. 104, Revenue Recognition , or SAB 104, and Financial Accounting Standards Board, or FASB, Emerging Issue Task Force, or EITF, Issue No. 00-21, Accounting for Revenue Arrangements with Multiple Deliverables , or EITF 00-21. Revenue-generating research and development collaborations are often multiple element arrangements, providing for a license as well as research and development services. Such arrangements are analyzed to determine whether the deliverables, including research and development services, can be separated or whether they must be accounted for as a single unit of accounting in accordance with EITF 00-21. We recognize upfront license payments as revenue upon delivery of the license only if the license has standalone value and the fair value of the undelivered performance obligations can be determined. If the fair value of the undelivered performance obligations can be determined, such obligations would then be accounted for separately as performed. If the license is considered to either (i) not have standalone value or (ii) have standalone value but the fair value of any of the undelivered performance obligations cannot be determined, the arrangement would then be accounted for as a single unit of accounting and the upfront license payments are recognized as revenue over the estimated period of when our performance obligations are performed.

 

When we determine that an arrangement should be accounted for as a single unit of accounting, we must determine the period over which the performance obligations will be performed and revenue related to upfront license payments will be recognized. Revenue will be recognized using either a proportionate performance or straight-line method. We recognize revenue using the proportionate performance method provided that we can reasonably estimate the level of effort required to complete our performance obligations under an arrangement and such performance obligations are provided on a best-efforts basis. Direct labor hours or full-time equivalents are typically used as the measure of performance. Under the proportionate performance method, periodic revenue related to upfront license payments is recognized as the percentage of actual effort expended in that period to total effort budgeted for all of our performance obligations under the arrangement. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which

 

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we expect to complete our related performance obligations. Estimates may change in the future, resulting in a change in the amount of revenue recognized in future periods.

 

Collaborations may also involve substantive milestone payments. 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: (1) the milestone payments are non-refundable, (2) achievement of the milestone involves a degree of risk and was not reasonably assured at the inception of the arrangement, (3) substantive effort is involved in achieving the milestone, (4) the amount of the milestone payment is reasonable in relation to the effort expended or the risk associated with achievement of the milestone and (5) a reasonable amount of time passes between the upfront license payment and the first milestone payment as well as between each subsequent milestone payment.

 

Reimbursement of costs is recognized as revenue provided the provisions of EITF Issue No. 99-19 are met, the amounts are determinable and collection of the related receivable is reasonably assured.

 

Stock-Based Compensation

 

Through December 31, 2005, we accounted for grants of stock options and restricted stock utilizing the intrinsic value method in accordance with Accounting Principle Board Opinion No. 25, Accounting for Stock Issued to Employees , and, accordingly, recognized no compensation expense for an option when the option had an exercise price equal to or greater than the fair market value at the date of grant. In addition, prior to the adoption of Statement of Financial Accounting Standards, or SFAS, No. 123R, Share-Based Payment , or SFAS No. 123R, we followed the disclosure-only provisions of SFAS No. 123, Accounting for Stock-Based Compensation , or SFAS No. 123, as amended by SFAS No. 148, Accounting for Stock-Based Compensation—Transition and Disclosure , or SFAS No. 148.

 

We occasionally grant stock option awards to consultants. Such grants are accounted for pursuant to 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 , and, accordingly, we recognize compensation expense equal to the fair value of such awards and amortize such expense over the performance period. We estimate the fair value of each award using the Black-Scholes-Merton, or Black-Sholes, model. The unvested equity instruments are revalued on each subsequent reporting date until performance is complete, with an adjustment recognized for any changes in their fair value. We amortize expense related to non-employee stock options in accordance with FASB Interpretation 28.

 

Effective January 1, 2006, we began accounting for grants of stock options and restricted stock to employees utilizing the fair value recognition provisions of SFAS No. 123R.

 

We primarily grant qualified stock options for a fixed number of shares to employees with an exercise price equal to the market value of the shares at the date of grant. Under the fair value recognition provisions of SFAS No. 123R, stock-based compensation cost is measured at the grant date based on the value of the award and is recognized as expense over the requisite service period of the award. Determining the fair value of stock-based awards at the grant date requires judgment, including estimating the expected term of stock options, the expected volatility of our stock and expected dividends. In addition, judgment is also required in estimating the amount of stock-based awards that are expected to be forfeited. If actual results differ significantly from these estimates, stock-based compensation expense and our results of operations could be materially impacted. The fair value of each award is estimated using the Black-Scholes model. Please see note 10 to the financial statements included in this prospectus for additional information regarding the adoption of SFAS No. 123R.

 

We adopted SFAS No. 123R utilizing modified prospective application, or MPA. Under MPA, we applied SFAS No. 123R for new awards granted after December 31, 2005 and for any awards that were granted prior to December 31, 2005 but were still vesting after December 31, 2005. As of June 30, 2006, no liability awards have been granted.

 

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We also had a choice of two attribution methods for allocating compensation cost under SFAS No. 123R: the “straight-line” method, which allocates expense on a straight-line basis over the requisite service period of the last separately vesting portion of an award, or the “graded vesting attribution method,” which allocates expense on a straight-line basis over the requisite service period for each separately vesting portion of the award as if the award was, in-substance, multiple awards. We chose the straight-line method.

 

We also chose to continue utilizing the Black-Scholes model as our option-pricing model. We concluded that this was the most appropriate method for valuing our share-based payment arrangements. However, if we grant any share-based payment instruments for which the Black-Scholes method does not meet the measurement objective as stated within SFAS No. 123R, we would utilize a more appropriate method for valuing that instrument. At this time, we do not believe that any instruments granted to date and accounted for under SFAS No. 123R would require a method other than Black-Scholes in order to meet the measurement objective discussed above.

 

We also revisited our conclusions regarding the assumptions that underlie the valuation of share-based payment awards. With respect to the calculation of expected term, we chose to utilize the “simplified” method for “plain vanilla” options as discussed within SAB No. 107, or SAB 107. We believe that all factors listed within SAB 107 as prerequisites for utilizing the simplified method are true for our share-based payment arrangements. We currently intend to utilize the simplified method through December 31, 2007, at which point we anticipate that more detailed information about exercise behavior will be more widely available. When valuing share-based payment awards reported via pro forma results for SFAS No. 123 and SFAS No. 148 prior to the adoption of SFAS No. 123R, an estimate of a five-year expected term for all employees as one weighted-average group was utilized, as this represented an estimate at the lower end of the reasonable range of possible expected terms, given the vesting schedule and maximum contractual maturity, in accordance with the guidance for estimates provided in SFAS No. 123.

 

For the calculation of expected volatility, because we are currently a private company and therefore lack company-specific historical and implied volatility information, we based our estimate of expected volatility on the historical volatility of similar entities whose share prices are publicly available. We intend to continue to consistently apply this process using the same group of similar entities until sufficient historical information regarding the volatility of our share price becomes available, or unless circumstances change such that the identified entities are no longer similar to us. In this latter case, more suitable, similar entities whose share prices are publicly available would be utilized in the calculation. This conclusion and approach is consistent with the approach utilized by management when valuing share-based payment awards reported via pro forma results for SFAS No. 123 and SFAS No. 148.

 

Under SFAS No. 123R, we have separated our employees into two groupings: management, including the board of directors, and non-management. However, given our current use of the simplified method, as discussed above, the establishment of these groupings will not affect the expected term we utilize until we cease to employ the simplified method of estimating expected term. We viewed all employees as one grouping when valuing share-based payment awards reported via pro forma results for SFAS No. 123 and SFAS No. 148 prior to the adoption of SFAS No. 123R.

 

The risk-free rate utilized when valuing share-based payment arrangements is based on the U.S. Treasury yield curve in effect at the time of grant for the expected term of the particular instrument being valued. This is consistent with the approach we utilized when valuing share-based payment awards reported via pro forma results for SFAS No. 123 and SFAS No. 148.

 

As of June 30, 2006, due to the adoption of SFAS No. 123R, the total compensation cost related to nonvested options not yet recognized in the financial statements is approximately $760,000 (unaudited), and the weighted average period over which it is expected to be recognized is 1.6 years.

 

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Based on an expected initial public offering price of $15.00 per share, the intrinsic value of the options outstanding at June 30, 2006 was $10,558,435, of which $4,763,266 related to vested options and $5,795,169 related to unvested options.

 

Determining the market value of our stock requires making complex and subjective judgments. Our management and board of directors concluded on the market value of our common stock after performing an internal evaluation, which included consideration of market conditions, comparable companies and, in 2005, an unrelated third-party valuation analysis. Our approach to enterprise valuation is based on an analysis of comparable companies, as well as on an income approach, which uses discounted future cash flow that includes our estimates of revenue, driven by assumed market growth rates, and estimated costs as well as appropriate discount rates. These estimates are consistent with the plans and estimates we use to manage our business. The enterprise value is then allocated to preferred and common shares using the option-pricing method. The option-pricing method involves making estimates of the anticipated timing of a potential liquidity event, such as a sale of our company or an initial public offering, and estimates of the volatility of our enterprise value. The anticipated timing is based on the plans of our board of directors and management. Estimating the volatility of the share price of a privately held company is complex because there is no readily available market for the shares. We estimated the volatility of our enterprise value based on available information on volatility of stocks of publicly traded companies in our industry. Had we used different estimates, the allocations between preferred and common shares would have been different.

 

As disclosed in notes 4 and 10 to our financial statements included elsewhere in this prospectus, during 2005, we engaged Fletcher Spaght Inc., a third-party valuation firm, to assist our board of directors in assessing the market value of our common stock as of November 2004. This valuation analysis utilized the methods outlined above, as well as the AICPA Practice Aid, Valuation of Privately Held Company Equity Securities Issued as Compensation . During 2005, we granted stock options to acquire 15,159 shares of common stock at an exercise price of $1.60 per share and 252,618 shares at an exercise price of $4.00 per share, of which 250,118 options were granted on December 20, 2005 as part of our recurring year-end compensation adjustments. For purposes of determining the market value of common stock underlying these grants, the board of directors considered company specific information, comparable companies, market conditions and the analysis of Fletcher Spaght and determined that the market value of our common stock throughout 2005 was $4.00 per share. Our board of directors made this valuation assessment based on feedback on our value from third-party prospective investors during fund-raising activities during 2005, as well as the absence of value-accreting business or scientific milestones during the intervening period from the independent valuation to the grant date. Specifically, we had not yet initiated any key clinical trials or received any key clinical trial data related to either elvucitabine or ACH-806.

 

There is inherent uncertainty in making valuation estimates. Although it is reasonable to expect that the completion of the initial public offering will add value to the shares because they will have increased liquidity and marketability, the amount of additional value cannot be measured with precision or certainty.

 

Accrued Expenses

 

As part of the process of preparing financial statements, we are required to estimate accrued expenses. This process involves identifying services which have been performed on our behalf and estimating the level of service performed and the associated cost incurred for such service as of each balance sheet date in our financial statements.

 

In accruing service fees, we estimate the time period over which services will be provided and the level of effort in each period. If the actual timing of the provision of services or the level of effort varies from the estimate, we will adjust the accrual accordingly. The majority of our service providers invoice us monthly in arrears for services performed. In the event that we do not identify costs that have begun to be incurred or we underestimate or overestimate the level of services performed or the costs of such services, our actual expenses could differ from such estimates. The date on which some services commence, the level of services performed on or before a given date and the cost of such services are often subjective determinations. We make judgments based upon facts and circumstances known to us in accordance with GAAP.

 

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In July 2006, FASB issued Interpretation No. 48, Accounting for Uncertainty in Income Taxes—an interpretation of FASB Statement No. 109 , or FIN 48. FIN 48 prescribes a comprehensive model for how a company should recognize, measure, present and disclose in its financial statements uncertain tax positions that the company has taken or expects to take on a tax return (including a decision whether to file or not file a return in a particular jurisdiction). Under FIN 48, the financial statements will reflect expected future tax consequences of such positions presuming the taxing authorities’ full knowledge of the position and all relevant facts, but without considering time values. FIN 48 substantially changes the applicable accounting model and is likely to cause greater volatility in income statements as more items are recognized discretely within income tax expense. FIN 48 also revises disclosure requirements and introduces a prescriptive, annual tabular rollforward of the unrecognized tax benefits. FIN 48 is effective for Achillion beginning January 1, 2007. We are evaluating the impact of adopting FIN 48 on our financial position and results of operations.

 

Results of Operations

 

Results of operations may vary from period to period depending on numerous factors, including the timing of payments received under existing or future strategic alliances, joint ventures or financings, if any, the progress of our research and development projects, technological advances and determinations as to the commercial potential of proposed products.

 

Comparison of Six Months Ended June 30, 2005 and 2006

 

Revenue . Revenue was $4.9 million and $4.3 million for the six months ended June 30, 2005 and 2006, respectively. The decrease in 2006 as compared to 2005 was due to the fewer number of Achillion personnel hours charged to the ACH-806 program, as well as increased costs related to ACH-806 formulation and manufacturing incurred by Gilead Sciences. Under our collaboration with Gilead Sciences, we recognize cost-sharing revenue as one-half of our costs under the ACH-806 program, less one-half of Gilead Sciences’ costs. Revenue consisted of the following:

 

     Six Months Ended June 30,

         2005    

       2006    

     (in thousands)

Amortization of up-front and milestone payments

   $ 2,705    $ 2,500

Cost-sharing revenue

     2,107      1,660

Grant revenue

     53      158
    

  

Total revenue

   $ 4,865    $ 4,318
    

  

 

Through the joint research committee established by our collaboration agreement with Gilead Sciences, we are currently in discussions with Gilead Sciences regarding whether certain full-time employee or equivalent time billed by Gilead Sciences to the collaboration during 2006 is allowed under the collaboration agreement. During 2006, we reduced our collaboration revenue from Gilead Sciences by these billed amounts and recorded only the revenue to date under the collaboration that is fixed and determinable. We will recognize additional revenue, if any, in future periods if the joint research committee determines that such amounts billed were not allowed under the collaboration agreement. We expect that such amounts, if any, would be less than $400,000.

 

In the first quarter of 2007, we expect to complete the proof-of-concept clinical trial for ACH-806, after which our cost-sharing and amortization revenue under the collaboration with Gilead Sciences will have been substantially recognized.

 

Research and development expenses . Research and development expenses were $9.4 million and $11.0 million for the six months ended June 30, 2005 and 2006, respectively. The approximate $1.6 million increase from 2005 to 2006 was the result of: (i) increased personnel costs for our research and development staff, including an increase in headcount as well as increased wages, (ii) the costs associated with on-going clinical trials using elvucitabine, as compared to one on-going trial during the first half of 2005, and (iii) the costs

 

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associated with phase I clinical development of ACH-806. In addition, during the first half of 2006, we incurred increased costs associated with the manufacturing and formulation of both elvucitabine and ACH-806. Research and development expenses for the six months ended June 30, 2005 and 2006 are comprised as follows:

 

     Six Months Ended June 30,

   Change

 
         2005    

       2006    

  
     (in thousands)  

Personnel costs

   $ 2,600    $ 3,028    $ 428  

Outsourced research and supplies

     4,582      5,582      1,000  

Professional and consulting fees

     667      873      206  

Facilities costs

     1,423      1,353      (70 )

Travel and other costs

     143      133      (10 )
    

  

  


Total

   $ 9,415    $ 10,969    $ 1,554  
    

  

  


 

General and administrative expenses . General and administrative expenses were $1.6 and $2.2 million for the six months ended June 30, 2005 and 2006, respectively. The approximate $597,000 increase from 2005 to 2006 was due to increased professional fees, particularly legal and accounting fees. We expect that general and administrative expenses will increase in the future due to increased payroll, expanded infrastructure, increased consulting, legal, accounting and investor relations expenses associated with being a public company. General and administrative expenses for the six months ended June 30, 2005 and 2006 are comprised as follows:

 

     Six Months Ended
June 30,


   Change

 
         2005    

       2006    

  
     (in thousands)  

Personnel costs

   $ 887    $ 995    $ 108  

Professional and consulting fees

     213      709      496  

Facilities costs

     321      350      29  

Travel and other costs

     198      162      (36 )
    

  

  


Total

   $ 1,619    $ 2,216    $ 597  
    

  

  


 

Interest income (expense ). Interest income was $142,000 and $267,000 for the six months ended June 30, 2005 and 2006, respectively. The $125,000 increase from 2005 to 2006 was primarily due to increased average cash balances over the six-month period. Cash balances increased on March 22, 2006 and May 12, 2006 with receipt of $18.4 million in proceeds from the sale of shares of our series C-2 convertible preferred stock and $5.0 million in proceeds from a debt facility. Interest expense was $661,000 and $446,000 for the six months ended June 30, 2005 and 2006, respectively. The $215,000 decrease from 2005 to 2006 was primarily attributable to conversion of notes payable in November 2005, offset in part by interest expense on a debt facility entered into on December 30, 2005.

 

Tax Benefit . The State of Connecticut provides companies with the opportunity to forego certain research and development tax credit carryforwards in exchange for cash. The program provides for such exchange of the research and development credits at a rate of 65% of the annual incremental and non-incremental research and development credits, as defined. The amount of tax benefit we recognized in connection with this exchange program was $60,000 and $50,000 for the six months ended June 30, 2005 and 2006, respectively. The $10,000 decrease from 2005 to 2006 was due to the specific types of research and development expenses incurred and the decreasing amount of such costs incurred within the State of Connecticut.

 

Accretion of preferred stock dividends . Accretion of preferred stock dividends was $1.4 and $2.3 million for the six months ended June 30, 2005 and 2006, respectively. The $900,000 increase from 2005 to 2006 was due to an increased number of shares outstanding during the period, particularly 23,425,462 shares of series C-2 convertible preferred stock issued in November 2005, March 2006 and May 2006, some of which were outstanding for the first and second quarters of 2006 but not for the corresponding quarters of 2005.

 

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Comparison of Years Ended December 31, 2003, 2004 and 2005

 

Revenue . Revenue was $0, $807,000 and $8.5 million for the years ended December 31, 2003, 2004 and 2005, respectively. The increase in 2004 as compared to 2003 is due to the recognition of collaboration revenue under our agreement with Gilead Sciences, which was executed in November 2004. The increase in 2005 as compared to 2004 is due to recognition of a full year of collaboration revenue under this agreement. Revenue consisted of the following:

 

     Years Ended December 31,

         2003    

       2004    

       2005    

     (in thousands)

Amortization of up-front and milestone payments

   $ —      $ 446    $ 4,328

Cost-sharing revenue

     —        361      3,949

Grant revenue

     —        —        249
    

  

  

Total revenue

   $ —      $ 807    $ 8,526
    

  

  

 

Research and Development Expenses . Research and development expenses were $13.2 million, $14.8 million, and $18.1 million for the years ended December 31, 2003, 2004 and 2005, respectively.

 

The $1.6 million increase from 2003 to 2004 was the result of: (i) increased costs associated with early preclinical development of ACH-806, (ii) increased license costs associated with our collaboration with Gilead Sciences and (iii) increased consulting fees, offset somewhat by decreased personnel costs. Research and development expenses for the years ended December 31, 2003 and 2004 are comprised as follows:

 

     Years Ended December 31,

      
         2003    

       2004    

   Change

 
     (in thousands)  

Personnel costs

   $ 5,482    $ 5,108    $ (374 )

Outsourced research and supplies

     3,688      5,200      1,512  

Professional and consulting fees

     620      1,131      511  

Facility costs

     3,118      3,145      27  

Travel and other costs

     286      257      (29 )
    

  

  


Total

   $ 13,194    $ 14,841    $ 1,647  
    

  

  


 

The $3.3 million increase from 2004 to 2005 was the result of: (i) the increased costs ($1.0 million) associated with elvucitabine phase II clinical trials, (ii) the increased costs ($1.8 million) associated with completing IND-enabling preclinical testing of our HCV candidate, ACH-806, as well as costs associated with phase I clinical testing of ACH-806 and (iii) the costs ($495,000) associated with early preclinical toxicology research on our antibacterial candidate, ACH-702. In addition, we incurred increased costs associated with manufacturing and formulation of both elvucitabine and ACH-806.

 

Research and development expenses for the years ended December 31, 2004 and 2005 are comprised as follows:

 

     Years Ended December 31,

      
         2004    

       2005    

   Change

 
     (in thousands)  

Personnel costs

   $ 5,108    $ 5,301    $ 193  

Outsourced research and supplies

     5,200      8,227      3,027  

Professional and consulting fees

     1,131      1,448      317  

Facility costs

     3,145      2,870      (275 )

Travel and other costs

     257      266      9  
    

  

  


Total

   $ 14,841    $ 18,112    $ 3,271  
    

  

  


 

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The majority of research and development expenses can be directly attributed to our two clinical-stage programs. We expect research and development costs to increase significantly over the next several years as our drug development programs progress.

 

General and Administrative Expenses . General and administrative expenses were $3.3 million, $3.2 million and $3.1 million for the years ended December 31, 2003, 2004 and 2005, respectively. The approximate $80,000 decrease from 2003 to 2004 was primarily attributable to cost savings in professional fees, partially offset by increases in facility, travel and other costs and personnel costs. General and administrative expenses for the years ended December 31, 2003 and 2004 are comprised as follows:

 

     Years Ended December 31,

      
         2003    

       2004    

   Change

 
     (in thousands)  

Personnel costs

   $ 1,635    $ 1,709    $ 74  

Professional fees

     808      547      (261 )

Facility costs

     525      584      59  

Travel and other costs

     293      341      48  
    

  

  


Total

   $ 3,261    $ 3,181    $ (80 )
    

  

  


 

The approximate $80,000 decrease from 2004 to 2005 was primarily a result of reduced professional fees and travel and other costs, partially offset by an increase in personnel costs, specifically annual pay increases, and increased facility costs. General and administrative expenses for the years ended December 31, 2004 and 2005 are comprised as follows:

 

     Years Ended December 31,

      
         2004    

       2005    

   Change

 
     (in thousands)  

Personnel costs

   $ 1,709    $ 1,803    $ 94  

Professional fees

     547      424      (123 )

Facility costs

     584      627      43  

Travel and other costs

     341      247      (94 )
    

  

  


Total

   $ 3,181    $ 3,101    $ (80 )
    

  

  


 

We expect that general and administrative expenses will increase significantly in the future due to increased payroll, expanded infrastructure and the increased consulting, legal, accounting and investor relations expenses associated with being a public company.

 

Interest Income/(Expense ). Interest income was $178,000, $84,000 and $224,000 for the years ended December 31, 2003, 2004 and 2005, respectively. The $94,000 decrease from 2003 to 2004 was the result of decreased cash balances upon which interest is earned. The $140,000 increase from 2004 to 2005 was primarily due to increased cash balances resulting from receipts from the issuance of convertible notes in 2004. Interest expense was $348,000, $593,000 and $1.2 million for the years ended December 31, 2003, 2004 and 2005, respectively. The $245,000 increase from 2003 to 2004 was attributable to the issuance of convertible promissory notes in the second half of 2004. The $607,000 increase from 2004 to 2005 was primarily due to interest due on convertible promissory notes issued in 2004, outstanding for eleven months during 2005 as compared to five months in 2004.

 

Tax Benefit . The State of Connecticut provides companies with the opportunity to forego certain research and development tax credit carryforwards in exchange for cash. The program provides for such exchange of the research and development credits at a rate of 65% of the annual incremental and non-incremental research and development credits, as defined. The amount of tax benefit we recognized in connection with this exchange program was $871,000, $264,000 and $88,000 for the years ended December 31, 2003, 2004 and 2005, respectively. The $607,000 decrease from 2003 to 2004 was due to a reduction in the rate at which our research

 

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and development costs increased, as the rate of increase is one factor in determining the amount of tax credit allowed. The $176,000 decrease from 2004 to 2005 was due to the specific types of research and development expenses incurred and the decreasing amount of such costs incurred within the State of Connecticut, as well as the partial reimbursement of expenses by Gilead Sciences.

 

Accretion of Preferred Stock Dividends . Accretion of convertible preferred stock dividends was $2.6 million, $2.6 million and $2.9 million for the years ended December 31, 2003, 2004 and 2005, respectively. The $16,000 increase from 2003 to 2004 was attributable to the issuance of series C-1 convertible preferred stock to Gilead Sciences in connection with the execution of our agreement with Gilead Sciences in November 2004. The $351,000 increase from 2004 to 2005 was due to this issuance of series C-1 convertible preferred stock in November 2004, which was outstanding for the entire period in 2005, as well as the issuance of series C-2 convertible preferred stock in November 2005.

 

Liquidity and Capital Resources

 

Since our inception in August 1998, we have financed our operations primarily through the issuance of our convertible preferred stock and borrowings under debt facilities, as well as through receipts from our collaboration with Gilead Sciences. Through June 30, 2006, we had received approximately $101.8 million in aggregate net proceeds from stock issuances, $15.2 million from Gilead Sciences under our collaboration agreement with them and approximately $15.5 million under the following debt facilities:

 

Lender


  Date

  Interest Rate
(per annum)


 

Principal

Amount


  Maturity Date

Connecticut Innovations, Inc.

  November 2000   7.5%   $ 1,400,000   September 2010

Connecticut Innovations, Inc.

  May 2002   7.5%   $ 278,000   October 2007

General Electric Capital Corporation

  March 2002   8.01%-10.17%   $ 3,264,182   March 2005-May 2007

Webster Bank

  May 2003   6.72%-8.72%   $ 591,630   June 2006-May 2008

Oxford Finance Corporation

  December 2005   10.92%   $ 2,500,000   November 2008

General Electric Capital Corporation

  December 2005   10.92%   $ 2,500,000   November 2008

Oxford Finance Corporation

  May 2006   11.56%   $ 2,500,000   April 2009

General Electric Capital Corporation

  May 2006   11.56%   $ 2,500,000   April 2009

 

Please see note 8 to the financial statements included in this prospectus for additional information regarding our debt facilities.

 

We had $14.4 million, $9.6 million and $20.2 million in cash, cash equivalents and marketable securities as of December 31, 2004 and 2005 and June 30, 2006, respectively. On May 12, 2006, we received $13.8 million in gross proceeds from the sale of 9,166,167 additional shares of our series C-2 convertible preferred stock at $1.50 per share, and $5.0 million in proceeds from the issuance of promissory notes under existing debt facilities.

 

Cash used in operating activities was $14.0 million for the year ended December 31, 2005 and was primarily attributable to our $13.6 million net loss, and the $2.3 million amortization of deferred revenue, offset somewhat by $2.1 million in non-cash charges such as depreciation, amortization and non-cash interest expense. Cash used in operating activities was $6.8 million for the corresponding period in 2004, and was primarily attributable to our $17.5 million net loss, offset in part by receipt of an $8.0 million up-front payment under our agreement with Gilead Sciences. Cash used in operating activities was $11.4 million for the six months ended June 30, 2006 and was primarily attributable to our net operating loss and the $2.5 million amortization of deferred revenue.

 

Cash provided by investing activities was $4.9 million for the year ended December 31, 2005 and was primarily attributable to the maturity of marketable securities. Cash used in investing activities was $3.2 million

 

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for the corresponding period in 2004, and was primarily attributable to the purchase of marketable securities, offset by maturities of marketable securities. Cash used in investing activities was $10,000 during the six months ended June 30, 2006.

 

Cash provided by financing activities was $9.3 million for the year ended December 31, 2005 and was primarily attributable to the receipt of proceeds from the sale of series C-2 convertible preferred stock, as well as the receipt of proceeds under a debt facility. Cash provided by financing activities was $11.3 million for the corresponding period in 2004, and was primarily attributable to the issuance of convertible promissory notes in July 2004 and November 2004. Cash provided by financing activities was $22.0 million for the six months ended June 30, 2006 and was primarily attributable to $18.2 million in proceeds from the issuance of an additional 12,270,815 shares of our series C-2 convertible preferred stock on March 22, 2006 and May 12, 2006 and $5.0 million in proceeds from the issuance of debt on May 12, 2006.

 

We expect to incur continuing and increasing losses from operations for at least the next several years. In particular, as described above, we expect to incur increasing research and development expenses and general and administrative expenses in the future. We anticipate that our cash balance, excluding the proceeds from this offering, and interest thereon, as supplemented by research funding pursuant to our collaboration with Gilead Sciences, will be sufficient to fund our current and planned operations into at least the second quarter of 2007. Prior to our May 2006 financings, there was substantial doubt about our ability to continue as a going concern. After consideration of such financings, management believes this substantial doubt has been alleviated and that we have adequate liquidity to fund operations for at least twelve months from the date of the May 2006 financings.

 

We believe that the net proceeds from this offering, together with interest thereon and our existing cash and cash equivalents, as supplemented by research funding pursuant to our collaboration with Gilead Sciences, will be sufficient to meet our projected operating requirements into the third quarter of 2008.

 

However, our funding requirements may change and will depend upon numerous factors, including but not limited to:

 

    the progress of our research and development programs;

 

    the timing and results of preclinical testing and clinical studies;

 

    the receipt and timing of regulatory approvals, if any;

 

    determinations as to the commercial potential of our proposed products;

 

    the status of competitive products;

 

    our ability to establish and maintain collaborative arrangements with others for the purpose of funding certain research and development programs;

 

    the acquisition of technologies or drug candidates; and

 

    our participation in the manufacture, sale and marketing of any approved drugs.

 

We anticipate that we will augment our cash balance through financing transactions, including the issuance of debt or equity securities and further corporate alliances. No arrangements have been entered into for any future financing, and there can be no assurance that we will be able to obtain adequate levels of additional funding on favorable terms, if at all. If adequate funds are not available, we may be required to:

 

    delay, reduce the scope of or eliminate our research and development programs;

 

    reduce our planned commercialization efforts;

 

    obtain funds through arrangements with collaborators or others on terms unfavorable to us or that may require us to relinquish rights to certain drug candidates that we might otherwise seek to develop or commercialize independently; and/or

 

    pursue merger or acquisition strategies.

 

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Additionally, any future equity funding may dilute the ownership of our equity investors.

 

Contractual Obligations

 

The following table sets forth a summary of our commitments as of June 30, 2006:

 

     Payment Due by Period

     Total

   Less Than
1 Year


   1-3 Years

   3-5 Years

   More than
5 Years


     (in thousands)

Long-term debt

   $ 12,315    $ 4,376    $ 7,072    $ 867    $ —  

Operating lease obligations

     4,057      947      1,953      1,157      —  

Clinical research obligations

     4,666      4,666      —        —        —  

Other research obligations and licenses

     3,608      3,137      243      228      —  
    

  

  

  

  

Total

   $ 24,646    $ 13,126    $ 9,268    $ 2,252    $ —  
    

  

  

  

  

 

The above amounts exclude potential payments that are based on the progress of our drug candidates in development, to be made under our license agreements, as these payments are not yet determinable.

 

Off-Balance Sheet Arrangements

 

As more fully explained in notes 9 and 10 to the audited financial statements included elsewhere in this prospectus, our preferred stock and certain of our warrants have conversion or other rights which meet the definition of a derivative; the majority of these meet the scope exception within SFAS 133, Accounting for Derivative Instruments and Hedging Activities . Otherwise, we currently have no other off-balance sheet arrangements.

 

Qualitative and Quantitative Disclosures About Market Risk

 

Interest Rate Risk

 

Our exposure to market risk is confined to our cash, cash equivalents and marketable securities. We invest in high-quality financial instruments, primarily money market funds, federal agency notes, asset backed securities, corporate debt securities and U.S. treasury notes, with the effective duration of the portfolio less than six months and no security with an effective duration in excess of 12 months, which we believe are subject to limited credit risk. We currently do not hedge interest rate exposure. Due to the short-term nature of our investments, we do not believe that we have any material exposure to interest rate risk arising from our investments.

 

Capital Market Risk

 

We currently have no product revenues and depend on funds raised through other sources. One source of funding is through further equity offerings. Our ability to raise funds in this manner depends upon capital market forces affecting our stock price.

 

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BUSINESS

 

Overview

 

We are a biopharmaceutical company focused on the discovery, development and commercialization of innovative treatments for infectious diseases. Within the anti-infective market, we are currently concentrating on the development of antivirals for the treatment of HIV infection and chronic hepatitis C and the development of antibacterials for the treatment of serious hospital-based bacterial infections. We have advanced our lead drug candidate, elvucitabine for the treatment of HIV infection, into phase II clinical trials and our second clinical-stage drug candidate, ACH-806 for the treatment of chronic hepatitis C, into a proof-of-concept clinical trial in collaboration with Gilead Sciences. In addition, we are evaluating our third drug candidate, ACH-702 for the treatment of serious hospital-based bacterial infections, in late-stage preclinical studies.

 

We believe that the development of anti-infective drugs offers significant advantages. The emergence of drug resistance seen with current antiviral and antibacterial therapy creates a continuing need for new drugs, which we believe provides us with a large and growing business opportunity. Infectious disease research and development programs generally have shorter development cycle times when compared to other therapeutic areas such as oncology, cardiovascular and central nervous system disorders.

 

We have established our drug candidate pipeline through our internal discovery capabilities and through the in-licensing of an attractive drug candidate. Through these efforts we have identified and are developing the following three lead drug candidates:

 

    Elvucitabine for HIV Infection. Elvucitabine, an antiviral we are developing for the treatment of HIV infection, is our most advanced clinical-stage drug candidate. We are currently evaluating elvucitabine in phase II clinical trials to further explore its safety and efficacy in HIV-infected patients. We have recently completed one of these phase II clinical trials. Results from this trial demonstrated that patients who received a once-daily 10 mg dose of elvucitabine for seven days experienced a significant mean viral load reduction as compared to those patients who received a placebo. These results are based on a small number of patients in an early-stage clinical trial, and are not necessarily predictive of results in later-stage clinical trials with larger and more diverse patient populations. If we receive additional favorable data from our other phase II trials, we expect to initiate phase III clinical trials in 2007. Elvucitabine is a member of the NRTI class of compounds, the predominant class of drugs used in the current standard of care for HIV therapy. Currently marketed drugs have several therapeutic limitations, including the development of HIV strains that are resistant to currently approved drugs, short half-lives which exacerbate drug resistance, inadequate patient compliance due to adverse side effects and complex dosing schedules, and limited combination treatment options due to cross resistance and drug-to-drug interactions. Elvucitabine has demonstrated potent antiviral activity against HIV, including HIV strains that are resistant to frequently prescribed NRTIs, as well as a half-life significantly longer than that of currently approved NRTIs. We believe this profile will allow us to position elvucitabine, if approved, favorably in the NRTI market. We currently retain full development and marketing rights to elvucitabine.

 

   

ACH-806 for Chronic Hepatitis C Infection. Our second clinical-stage drug candidate, ACH-806 (also known as GS 9132), which we are developing in collaboration with Gilead Sciences, is currently being evaluated in a proof-of-concept clinical trial for the treatment of chronic hepatitis C that we initiated in August 2006. We expect to complete this clinical trial and have results available in the first quarter of 2007. In preclinical studies, ACH-806 demonstrated potent inhibition of the replication of HCV, the virus that causes hepatitis C. In a recently completed phase I clinical trial, results indicated that ACH-806 was safe and well tolerated in healthy volunteers. We believe ACH-806 offers several potential advantages compared to currently available treatments, including greater potency, a novel mechanism of action, lack of cross resistance and the potential for oral administration. We believe ACH-806 could be used in combination with the current standard of

 

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care, or with other therapies in development, to significantly improve treatment outcomes. In November 2004, we entered into a collaboration agreement and exclusive license with Gilead Sciences for the research, development and commercialization of compounds for the treatment of chronic hepatitis C, including ACH-806. We received $10.0 million from Gilead Sciences upon the execution of this agreement in the form of a license fee and equity purchase, and we are entitled to receive up to $157.5 million in development, regulatory and sales milestone payments, assuming successful development of a lead and back-up compound as well as royalties on net sales of products.

 

    ACH-702 for Serious Hospital-Based Bacterial Infections. Our most advanced preclinical candidate is ACH-702, which we are developing for the treatment of serious hospital-based bacterial infections. In several preclinical studies, ACH-702 has exhibited potent antibacterial activity against a large number of medically relevant bacteria, including methicillin resistant staphylococcus aureus strains, highly prevalent hospital-based infections. Preclinical studies to date have also suggested that the compound has a bacteria-killing mechanism of action and may be administrated in both intravenous and oral formulations. We expect to submit an IND for ACH-702 to the FDA in the first quarter of 2007.

 

In addition to our three lead drug candidates, we have earlier-stage preclinical programs focused on the treatment of HIV infection through the inhibition of viral proteins not targeted by currently marketed drugs, such as the capsid protein, and the treatment of HCV infection through compounds that have mechanisms of action that are distinct from ACH-806.

 

We intend to focus on the discovery of new drug candidates through our extensive expertise in virology, microbiology and synthetic chemistry. Utilizing these capabilities, we have thus far internally discovered our lead HCV compound, ACH-806, and our late-stage preclinical candidate, ACH-702. In the aggregate, members of our drug discovery, preclinical and clinical development team have contributed to the selection and development of more than 80 clinical candidates and 50 marketed products throughout their careers. We believe that our drug discovery capabilities will allow us to further expand our product portfolio, providing us with strong growth potential and reducing our reliance on the success of any single drug candidate.

 

Background

 

Infectious diseases are caused by pathogens present in the environment, such as viruses, bacteria and fungi, which enter the body through the skin or mucous membranes and overwhelm its natural defenses. Some infections affect the entire body, while others may be localized in one organ or system within the body. The severity of infectious diseases varies depending on the nature of the infectious agent, as well as the degree to which the body’s immune system can fight the infection. According to World Health Organization reports, infectious diseases, including HIV infection, chronic hepatitis C and drug-resistant bacterial infections, represent a significant cause of morbidity and mortality worldwide.

 

The market for anti-infective drugs can be divided into three main categories: antivirals, antibacterials (often referred to as antibiotics) and antifungals. To date, we have focused on the research and development of products for the antiviral and antibacterial markets. According to reports published by Datamonitor, in 2004, there were approximately $6.6 billion in worldwide sales of drugs to treat HIV infection, $2 billion in worldwide sales of antivirals for the treatment of chronic hepatitis C and $24 billion in worldwide sales of antibacterials.

 

The widespread use of anti-infective drugs has led to a significant reduction in morbidity and mortality associated with infectious diseases. However, for many infectious diseases, current treatment options are associated with suboptimal treatment outcomes, significant drug-related adverse side effects, complex dosing schedules and inconvenient methods of administration, such as injection or infusion. These factors often lead to patients discontinuing treatment or failing to comply fully with treatment dosing schedules. As a result, physicians are often required to modify therapy regimens throughout the course of treatment.

 

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Moreover, in recent years, the increasing prevalence of drug resistance has created ongoing treatment challenges for antiviral and antibacterial therapies. The ability of both viruses and bacteria to adapt rapidly to these treatments through genetic mutations allows new strains to develop that are resistant to currently available drugs. In addition, a patient’s failure to comply fully with a treatment regimen both accelerates and exacerbates drug resistance. This is particularly well documented for HIV treatments and antibacterials.

 

As a result of these treatment challenges, the industry is focused on developing anti-infective drugs that delay the emergence of drug resistance, improve patient compliance and improve treatment responses in infections associated with drug-resistant pathogens.

 

We believe there are significant business advantages to focusing on the development of drugs to treat infectious diseases, including the following:

 

    the emergence of drug resistance creates a continuing need for new drugs to combat infectious diseases, thus creating a large and growing business opportunity;

 

    infectious disease research and development programs generally have shorter development cycle times when compared to various therapeutic areas such as oncology, cardiovascular and central nervous system disorders; and

 

    that evidence suggests systemic anti-infectives have a higher clinical success rate compared to various therapeutic areas such as oncology, cardiovascular and central nervous system disorders.

 

Viruses

 

Viruses are submicroscopic infectious agents consisting of an outer layer of protein surrounding a core of genetic material comprised of DNA or RNA. Viruses require living host cells to grow and multiply. In many cases, the body’s immune system can effectively combat the viral infection. However, in certain viral infections, the body’s immune system is unable to destroy the virus, and the infection becomes chronic. In chronic infections, persistent viral replication and subsequent infection of healthy cells may, over time, lead to the deterioration or destruction of the infected cells, resulting in disease. Antiviral drugs are utilized to assist the body’s immune system in combating or eliminating the infection.

 

The development of resistance to antiviral drugs is a major challenge for the treatment of life-threatening viral infections such as HIV and chronic hepatitis C. The ability of viruses to mutate spontaneously during replication allows drug-resistant viral strains to emerge when patients are on treatment regimens that do not completely inhibit viral replication. This phenomenon has been particularly well documented in HIV. Resistance occurs because viruses continually make billions of copies of themselves, some of which will contain mutations in their genetic material. Mutations that confer a replication advantage in the presence of a suppressive antiviral drug will give rise to viral strains that are resistant or partially resistant to that antiviral drug. These mutated viruses, while initially found in low numbers, will eventually become the predominant strain in an infected patient. Once this occurs, the treatment benefit of the antiviral drug diminishes or disappears, which may result in treatment failure and create a need for an alternate therapy with new drugs.

 

Antiviral drug resistance is clinically managed by the administration of one or more potent direct-acting antiviral drugs and/or by enhancing the body’s immune system through treatment with an immune response modifier to apply the highest possible level of suppression against viral replication. These direct acting antiviral drugs prevent viral replication by disrupting processes that are essential for completion of a viral infection cycle. The most effective disruption generally results from the use of multiple drugs that have different mechanisms of action.

 

Bacteria

 

Bacteria are unicellular, self-propagating microorganisms that multiply through growth in bacterial cell size and the subsequent division of the cell. Bacteria can be broadly classified into two categories based upon the

 

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composition of their cell walls: gram-positive or gram-negative. Many antibacterial drugs that are effective against gram-positive bacteria are less effective or ineffective against gram-negative bacteria, and vice versa. Antibacterial drugs that are active against a large number of both classes of bacteria are often referred to as “broad-spectrum” antibacterials.

 

Bacteria adapt remarkably well to their surroundings due to the high level of variation found within bacterial DNA and the ability of bacteria to reproduce rapidly. Replication of bacterial DNA is often error prone and can result in a high frequency of mutations. Because the bacterial reproductive cycle is very short, ranging from minutes to several days, a mutation that helps a bacterium survive exposure to an antibiotic drug may quickly become dominant throughout the population. Additionally, bacteria can acquire segments of DNA from other bacteria and organisms, which can also convey drug resistance.

 

Currently marketed antibacterials have historically proved highly successful in controlling the morbidity and mortality that accompany bacterial infections. The first antibacterials, introduced over 60 years ago, were highly effective in limiting or completely inhibiting bacterial reproduction, and thus were considered miracle drugs. A majority of the antibiotics currently in use were developed and introduced into the market before 1980. However, due to the widespread use of antibacterials over time and the ability of bacteria to develop drug resistance, many of these antibiotics now have diminished or limited antibacterial activity. This problem is particularly acute in the hospital setting, where approximately 70% of certain types of serious infections are associated with multi-drug-resistant bacteria. The inability to effectively treat serious infections caused by drug-resistant bacteria has led to increased mortality rates, prolonged hospitalizations and increased health care costs. The rate at which bacteria are now developing resistance to multiple antibacterials, and the pace at which those multi-drug-resistant bacteria are spreading, represent significant medical challenges.

 

Our Strategy

 

Our objective is to become a leading infectious disease-focused biopharmaceutical company. We believe the infectious disease market is highly attractive due to its size, continued demand for new products to address the consequences of drug resistance and generally shorter development cycle times. In order to achieve our objective, we intend to:

 

    Advance the Development of Our Current Drug Candidates . We are developing our most advanced clinical compound, elvucitabine, for the treatment of HIV infection. We are developing our other clinical compound, ACH-806, in a collaboration and exclusive license arrangement with Gilead Sciences, for the treatment of chronic HCV infection. In addition, we are developing ACH-702 for the treatment of serious hospital-based bacterial infections and are progressing additional discovery stage candidates for the treatment of HIV infection and chronic hepatitis C. In particular, we expect to:

 

    complete our phase II clinical trials for elvucitabine in the first half of 2007 and, if supported by favorable data from the phase II trials, initiate phase III clinical trials in 2007;

 

    complete our proof-of-concept clinical trial of ACH-806 in the first quarter of 2007; and

 

    submit an IND to the FDA for ACH-702 in the first quarter of 2007.

 

  Expand our Infectious Disease Portfolio . We intend to leverage our expertise in synthetic chemistry, virology and microbiology to quickly and efficiently discover and develop additional anti-infective compounds. As recent examples of our capabilities, our research team designated clinical lead candidates in our HCV program (ACH-806) and antibacterial program (ACH-702) in fewer than 24 months from program inception. We may augment our internal discovery capabilities and further expand our pipeline by in-licensing and/or acquiring differentiated drug candidates (as we did with elvucitabine) or additional discovery technologies.

 

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  Accelerate Growth Through Selective Collaborations . We intend to establish strategic collaborations where we believe we can accelerate the development or maximize the value of our drug candidates by utilizing the financial, clinical development, manufacturing and/or commercialization strengths of a leading biotechnology or pharmaceutical company. As part of this strategy, we entered into a collaboration with Gilead Sciences in November 2004 for the development and commercialization of HCV compounds, including ACH-806, pursuant to which we received a significant up-front payment and are utilizing Gilead Sciences’ broad capabilities to accelerate the progress of this drug candidate.

 

  Pursue a Diversified Commercial Strategy. On a selected basis, we plan to participate in the eventual commercialization of our products. While we have granted Gilead Sciences worldwide commercialization rights for certain of our HCV compounds, including ACH-806, we have the option to participate on a limited basis in marketing efforts in the United States. In addition, we have retained all commercialization rights for elvucitabine and ACH-702. We intend eventually to build and deploy a focused, North American sales force to support the sales and marketing of those drug candidates for which it is possible to effectively and efficiently access the market. In addition, we may collaborate with other companies to co-promote our drug candidates in North America in instances where we believe a larger sales and marketing presence will expand the market or accelerate market penetration. We intend to utilize strategic alliances with third parties to commercialize our drugs in markets outside North America.

 

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Our Drug Candidates

 

The following table summarizes key information regarding our drug candidates:

 

Drug

Candidate/

Indication

   Target    Stage of
Development
   Current Status    Current
Marketing
Rights

Elvucitabine

HIV Infection

   HIV reverse transcriptase   

Phase II

  

•     Phase II placebo-controlled viral kinetics, safety and pharmacokinetics trial in HIV treatment-naive patients—recently completed

•     Phase II comparative viral kinetics, safety and pharmacokinetics trial in HIV treatment-experienced patients; currently screening—expected completion and data available in the first half of 2007

•     Phase II comparative safety, antiviral efficacy and pharmacokinetics trial in HIV treatment-naive patients—expected completion in the first quarter of 2007, with data anticipated to be available in the first half of 2007

  

Achillion

ACH-806

(also known as GS 9132) Chronic Hepatitis C Infection

  

HCV

protease

  

Proof-of-

Concept

 

 

 

 

 

  

•     Proof-of-concept multiple dose trial in HCV-infected patients commenced in August, 2006—expected completion and data available in the first quarter of 2007

   Gilead Sciences*
ACH-702 Serious Hospital-Based Bacterial Infections   

DNA

replication enzymes

   IND-enabling preclinical studies   

•     IND-enabling preclinical studies in progress—IND submission expected in the first quarter of 2007

  

Achillion

HIV Inhibitor HIV Infection    Nucleocapsid protein   

Discovery

  

•     Lead optimization studies in progress

  

Achillion

HCV Inhibitor Chronic HCV Infection   

Undisclosed

  

Discovery

  

•     Lead optimization studies in progress

  

Achillion

* Achillion has a one-time option to participate on a limited basis in marketing in the United States.

 

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Elvucitabine for HIV

 

Elvucitabine is an NRTI, which we are currently testing in phase II trials. Elvucitabine has demonstrated potent antiviral activity against HIV, including activity against HIV that contains mutations associated with resistance to other reverse transcriptase inhibitors such as Viread (tenofovir), Zerit (d4T) and Retrovir (AZT). Furthermore, elvucitabine has a significantly longer half-life than the other marketed drugs in its class. We believe that these attributes should allow elvucitabine to deliver consistent, potent antiviral activity to patients infected with HIV, particularly those patients with less than perfect compliance with their existing treatment regimens. We believe a treatment regimen containing elvucitabine may also delay the emergence of resistance and prolong the effectiveness of therapy. We recently completed the first of our phase II clinical trials. Because of the strict entry criteria for our second phase II trial, which is based on genotype analysis, we anticipate that the enrollment period will take several months. Therefore, we anticipate that the data from this trial will be available in the first half of 2007. We expect that the data from our third trial will be available in the first half of 2007.

 

If supported by favorable data from the phase II trials, we intend to initiate phase III trials in 2007.

 

Overview of HIV and HIV Market

 

HIV is a viral infection that, if left untreated, results in the development of the Acquired Immune Deficiency Syndrome, or AIDS. HIV is a retrovirus that uses RNA to encode its genetic material. When a person is infected with HIV, the virus infects cells that are associated with the body’s immune system. The most common cells infected are the T-helper lymphocytes, which are also called CD4 cells. After attaching to CD4 cells, the virus is taken inside the cell, where, using host-cell machinery, it replicates its genetic material into DNA, a process known as reverse transcription. This step is facilitated by the viral enzyme reverse transcriptase. The subsequent completion of the viral life cycle ultimately leads to the destruction of CD4 cells. When the CD4 cell count, as measured in the blood, falls below a certain level, a person’s immune system starts to fail, and a person becomes at risk for the development of AIDS and opportunistic infections.

 

HIV-infected patients are clinically managed by monitoring two key parameters in the blood—the number of CD4 cells and viral load, or the measurement of HIV RNA. The goal of antiviral treatment is to provide long-term suppression of HIV replication. This suppression allows the CD4 cells to increase toward normal levels, which decreases the likelihood of AIDS and/or death. Without treatment, HIV infection progresses to AIDS in 20-25% of infected individuals within six years and in 50% within ten years.

 

According to the Joint United Nations Programme on HIV/AIDS and the World Health Organization, an estimated 40 million people worldwide are infected with HIV. In addition, over 25 million people have died from AIDS since the epidemic began. The Centers for Disease Control and Prevention, or CDC, estimates that in the United States there were between 1,039,000 and 1,185,000 people living with HIV/AIDS in 2003, with 40,000 new infections annually. According to the Joint United Nations Programme on HIV/AIDS and the World Health Organization, in Europe and Central Asia there were approximately 2,320,000 people living with HIV/AIDS in 2005, with 292,000 new infections annually.

 

According to reports published by Datamonitor, the worldwide market for HIV therapeutics was $6.6 billion in 2004. A majority of these sales are derived from the North American and European pharmaceutical markets.

 

Currently, there is no cure for HIV infection. In addition, there are no preventative or therapeutic vaccines, but there are more than two dozen antiretroviral drugs on the market that target various steps in the HIV replication cycle. These can be divided into four drug classes that have been approved for the treatment of HIV infection:

 

    NRTIs;

 

    non-nucleoside reverse transcriptase inhibitors, or NNRTIs;

 

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    protease inhibitors; and

 

    fusion inhibitors.

 

NRTIs and NNRTIs prevent HIV replication by interacting with reverse transcriptase. NRTIs, such as Epivir (3TC), Emtriva (FTC), Viread (tenofovir), Retrovir (AZT) and Zerit (d4T), have become the predominant class of drugs in HIV therapy. Without successful reverse transcription, the virus is unable to reproduce itself. When reverse transcription occurs in the presence of an NRTI, the NRTI is incorporated into the newly synthesized DNA strand and stops the reverse transcription process, thus preventing a complete copy of the viral RNA from being transcribed into DNA. NNRTIs, such as Sustiva (efavirenz), also prevent HIV replication through an interaction with reverse transcriptase, but with a mechanism of action distinct from NRTIs.

 

Protease inhibitors, such as Kaletra (lopinavir + ritonavir) and Viracept (nelfinavir), prevent viral assembly by blocking the action of HIV protease, an enzyme that is required to produce new, infectious viruses. Fusion inhibitors, also known as entry inhibitors, such as Fuzeon (enfuvirtide), prevent HIV from fusing to CD4 cells, thereby preventing the initial infection of CD4 cells by HIV.

 

Because of its high spontaneous mutation rate, HIV is especially prone to the development of resistance to a single therapeutic drug. As a result, the treatment paradigm for HIV has evolved from monotherapy to triple combination treatment known as HAART, which includes drugs from multiple drug classes to maximally suppress HIV replication. In accordance with current Department of Health and Human Services HIV Treatment Guidelines, the initial or first-line HAART regimens typically include two NRTIs with non-overlapping resistance patterns and either an NNRTI or a protease inhibitor. The use of HAART to manage HIV infections has resulted in a dramatic reduction in disease progression to AIDS and/or death. It is now believed that HIV-infected individuals can often be clinically managed for decades through daily treatment with HAART.

 

Limitations of Current Therapies

 

In spite of the benefits of HAART, all currently approved drugs have significant limitations, including the following:

 

    Development of Drug Resistance. Ongoing viral replication in patients on a HAART regimen results in the emergence of viral strains that are no longer susceptible to one or more components of the regimen. If left unchecked, this may lead to treatment failure. In addition, development of resistance to certain drugs can lead to cross resistance, or resistance to other drugs of the same class, thus rendering a whole class of drugs ineffective. In order to regain viral suppression, patients failing a HAART regimen are switched to a new regimen comprised of drugs that are not cross resistant with drugs from previous regimens.

 

    Short Half-Lives of Currently Available Therapies. Many of the currently available drugs have relatively short plasma half-lives, meaning the length of time the drug remains in the patient’s bloodstream, as well as relatively short intracellular half-lives, meaning the length of time the drug remains in the patient’s cells. The plasma half-life of a majority of the NRTIs is in the range of one to several hours, and the intracellular half-life of a majority of the NRTIs is approximately 18-20 hours. Short half-lives require patients to take their medications more frequently, or in the case of once-daily dosing, to take doses within a certain timeframe. If patients miss this window, or forget entirely to take their medication, the amount of drug in the bloodstream diminishes, creating an opportunity for increased viral replication and the emergence of drug resistance.

 

    Inadequate Patient Compliance. A patient’s ability to adhere to a HAART regimen will impact the treatment outcome. Virologic failure rates have been found to directly correlate with the level of compliance. In studies, 61% of patients with 80 – 94.9% adherence and 80% of those with less than 80% adherence to their dosing regimen were found to experience virologic treatment failure. The chronic nature of HIV disease and the long-term adverse side effects associated with certain drugs, such as the loss of subcutaneous fat associated with certain NRTIs, affect the ability of HIV patients to adhere perfectly or nearly perfectly to dosing schedules.

 

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    Limited Treatment Options. Most current HAART regimens include two NRTIs. Although there are currently seven commonly used NRTIs, not all of them can be paired together due to cross resistance and drug-to-drug interactions. As resistance develops and the efficacy of treatment regimens diminishes over time, patients cycle through different HAART regimens, eventually exhausting all the available NRTI pairings. Therefore, we believe that there is a continuing need for new NRTIs.

 

Achillion Approach: Elvucitabine

 

Elvucitabine is an L-cytosine NRTI, belonging to the same class as 3TC and FTC. L-cytosine NRTIs represent the most frequently prescribed class of NRTIs based upon sales, accounting for approximately 34% of the worldwide NRTI market in 2004. We believe L-cytosine NRTIs are frequently prescribed given their established potency, favorable short and long-term safety profile and fewer and less adverse side effects. In addition, laboratory data demonstrate that HIV with the M184V genotype, the mutation conferring resistance to 3TC and FTC, is unable to replicate as effectively as HIV with other resistance mutations.

 

We believe elvucitabine addresses the limitations of currently available NRTIs in the following ways:

 

    Long Half-Life. Elvucitabine’s plasma half-life has been demonstrated in clinical trials to be over 100 hours, or up to 20 times greater than that of Epivir (3TC) and up to ten times greater than that of Emtriva (FTC). In addition, elvucitabine’s intracellular half-life has recently been demonstrated in a clinical trial to be over 100 hours, or more than five times greater than that of Epivir (3TC) and Emtriva (FTC). We believe this long half-life may mitigate the negative effects of less than perfect patient compliance, providing a more durable NRTI for use in HAART regimens.

 

    Superior Potency Against Common Resistance Mutations. The laboratory antiviral profile of elvucitabine demonstrates superior potency against many of the most common resistance mutations associated with NRTIs typically used in combination with Epivir (3TC) and Emtriva (FTC), including those associated with Viread (tenofovir), Retrovir (AZT) and Zerit (d4T). In addition, although elvucitabine’s resistance profile is similar to Epivir (3TC) and Emtriva (FTC), elvucitabine retains greater antiviral activity in laboratory tests against HIV with resistance to Epivir (3TC) and Emtriva (FTC). We believe this enhanced antiviral activity could provide an increased barrier to the emergence of drug resistance in patients and improve antiviral suppression in patients with emerging resistance to commonly used NRTIs.

 

    Patient Compliance. We believe that a well-tolerated L-cytosine NRTI with convenient, flexible oral dosing will enhance patient compliance and will make elvucitabine attractive as a component of HAART regimens. With a projected daily dose of elvucitabine of 10 mg in a tablet formulation, compared to 200 mg for Emtriva (FTC) and 300 mg for Epivir (3TC), we also believe elvucitabine could be an attractive candidate as part of a combination product for use in HAART regimens.

 

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Ongoing and Planned Clinical Development

 

Our current plans for clinical development of elvucitabine include the following phase II trials to further explore the safety and efficacy profile of elvucitabine in HIV-infected patients:

 

Trial Design


 

Population


 

Sites and
Location


  Patient
Number


 

Dosing
Duration


 

Status


Phase II placebo-controlled viral kinetics, safety and pharmacokinetics trial   HIV treatment-naïve patients   Single site in Europe   24   7 days   Complete.
Phase II comparative viral kinetics, safety and pharmacokinetics trial   HIV treatment-experienced patients   Ten sites in the United States, with an expected seven additional sites in Latin America and Europe   20   14 days, with an expected extension of 24 additional weeks   Currently screening; trial expected to be completed in the first half of 2007, with data available in the first half of 2007.
Phase II comparative safety, antiviral efficacy and pharmacokinetics trial   HIV treatment-naïve patients   20 sites in the United States   60   12 weeks, with extension to 24 weeks   Currently screening; trial expected to be completed in the first quarter of 2007, with data available in the first half of 2007.

 

We recently completed a randomized, double-blind phase II trial in which we evaluated the viral kinetics, safety and pharmacokinetics of elvucitabine in 24 treatment-naïve HIV patients, that is, patients who have not previously been treated for their HIV infection. Patients received once daily either 10 mg of elvucitabine or a placebo for seven days. An acceptable treatment response for this trial was defined as the elvucitabine cohort demonstrating greater reduction in HIV viral load on day seven, as compared to the viral load observed in patients taking a placebo. The results from this trial demonstrated that patients who received a 10 mg dose of elvucitabine once daily experienced a mean viral load reduction of 0.85 logs, or 83%, on day seven. Patients who received a placebo experienced a mean -0.06 log change, or <1%, at day seven. In addition, patients who received elvucitabine experienced a mean increase in CD4 cells of approximately 20%, compared to a mean increase of <1% in patients receiving a placebo. This trial further demonstrated that the plasma half-life of elvucitabine is greater than 100 hours and that its intracellular half-life is also greater than 100 hours. During this trial, elvucitabine had not achieved “steady state”, that is, the point at which minimum plasma levels no longer increase after repeat dosing. Based upon our previous clinical studies of elvucitabine, we believe elvucitabine’s steady state occurs following 21 days of dosing. Therefore, we believe that if we had dosed patients for longer than seven days, there would have been a further increase in patients’ viral reduction and CD4 cell counts, although we do not have any data from this clinical trial to support this belief. We observed no serious or clinically significant adverse events during this trial. These results are based on a small number of patients in an early-stage clinical trial and are not necessarily predictive of results in later-stage clinical trials with larger and more diverse patient populations.

 

We initiated a randomized, double-blind phase II trial in December 2005 in which we are evaluating the viral kinetics, safety and pharmacokinetics of elvucitabine in 20 HIV-infected patients who have failed a HAART regimen which included Epivir (3TC). Treatment failure is defined as the presence of the M184V mutation, which signifies Epivir (3TC) drug resistance. Patients receive either 10 mg of elvucitabine once daily in place of Epivir (3TC) or continue receiving 300 mg of Epivir (3TC) once daily for 14 days. The patients’ other two HAART regimen drugs remain unchanged. An acceptable treatment response for this trial is defined as the elvucitabine cohort demonstrating greater reduction in HIV viral load on day 14, as compared to the viral load

 

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observed in patients remaining on Epivir (3TC). If patients respond favorably, we expect to allow them to receive an additional 24 weeks of therapy with elvucitabine. Because of the strict entry criteria for this trial, which is based on genotype analysis, we anticipate that the enrollment period will take several months; therefore, we anticipate data from this trial will be available in the first half of 2007.

 

We initiated a randomized, double-blind phase II trial in May 2006 of elvucitabine in combination with two additional antiretrovirals (Sustiva (efavirenz) and Viread (tenofovir)), as compared to Epivir (3TC) in combination with the same two additional antiretrovirals, in 60 treatment-naïve HIV patients. We will evaluate the safety, antiviral efficacy and pharmacokinetics of 12 weeks of therapy with these two treatment regimens. An acceptable treatment response for this trial is defined as the patients demonstrating a viral load less than a specified level at the end of the initial 12-week period. If patients respond favorably, they may receive an additional 12 weeks of therapy with elvucitabine. We anticipate data from this trial to be available in the first half of 2007.

 

If we receive favorable data from these trials, following discussion with the FDA and European regulatory authorities, we expect to initiate phase III clinical trials in HIV-infected individuals in the United States and Europe in 2007, collecting data during 48 weeks of dosing in over 1,000 patients.

 

Clinical Development History

 

Between 2001 and 2003, we conducted several clinical trials to determine the safety, tolerability and pharmacokinetic profile of elvucitabine for use against both hepatitis B virus, or HBV, and HIV. Specifically, we conducted three phase I clinical trials in healthy subjects, two phase II clinical trials in patients infected with HBV, and one phase II clinical trial in patients infected with HIV. In the phase II clinical trials for HBV, we evaluated doses of 5, 10, 20 and 50 mg once daily and noted that all doses greater than 5 mg were effective in reducing HBV viral load by 99%, or 3.5log10 copies/ml. Despite this result, our current commercial plans do not include developing elvucitabine as a treatment for HBV. In the phase II clinical trial for HIV, we evaluated doses of 50 and 100 mg once daily and noted that both dose groups demonstrated reduction in viral load by 85%, or .7log10 copies/ml. We further noted that doses of 50 mg or greater per day were associated with an unacceptable reduction in the number of patients’ white and red blood cells. In 2003, the clinical trial was discontinued, and the elvucitabine program was placed on clinical hold while determination of the appropriate dosing regimen for elvucitabine was made.

 

In 2004, while operating under a partial clinical hold placed by the FDA, we evaluated the therapeutic window and pharmacokinetic profile of elvucitabine in HIV-infected patients with a 21-day, open label phase II clinical trial of 24 HIV treatment-naïve patients. The patients received elvucitabine at either 5 mg or 10 mg once daily, or 20 mg every 48 hours, in each case in combination with the protease inhibitor Kaletra (lopinavir + ritonavir). We made frequent measurements of elvucitabine plasma levels throughout the trial. Results from the trial demonstrated that all three doses are similar in antiviral activity, reducing the viral load by approximately 98%, or 1.9log10 copies/ml. All three doses also showed similar safety profiles without the occurrence of any serious adverse events, particularly white or red blood cell reduction. Importantly, the trial also demonstrated that the amount of elvucitabine present in patients’ plasma 24 hours following their previous dose was well in excess of those amounts necessary to deliver potent antiviral activity. From this trial, we concluded that the plasma half-life of elvucitabine is approximately 100 hours and chose a dose of 10 mg once daily for evaluation in our current phase II safety and efficacy trials in HIV-infected patients. Following the completion of this clinical trial, the FDA removed the partial clinical hold.

 

Preclinical Development History

 

We sublicensed elvucitabine from Vion Pharmaceuticals (which licensed the relevant patents and intellectual property from Yale University) and initiated development activities in 2000. In preclinical studies, elvucitabine has been shown to be approximately four-fold more potent in vitro than Epivir (3TC) against wild-type HIV, meaning HIV without mutations associated with drug resistance. In addition, elvucitabine demonstrates greater potency in vitro against HIV with resistance to most of the commonly used NRTIs such as

 

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Epivir (3TC), Retrovir (AZT), Zerit (d4T) and Viread (tenofovir). These studies were conducted at several laboratories with more than 70 clinical strains of HIV obtained from patients with drug resistance and eight laboratory strains of HIV with known reverse transcriptase resistance mutation profiles.

 

ACH-806 for HCV Infection

 

ACH-806 (also known as GS 9132) is a potent inhibitor of HCV replication with a novel mechanism of action involving HCV protease that we identified through our internal drug discovery capabilities. In November 2004, we entered into a strategic alliance with Gilead Sciences for the discovery, development and commercialization of compounds to treat chronic hepatitis C, including ACH-806. Pursuant to this collaboration, we are currently testing ACH-806 in a proof-of-concept clinical trial, and we expect data to be available from this trial in the first quarter of 2007.

 

Overview of HCV and HCV Market

 

HCV is a virus which is a common cause of viral hepatitis, an inflammation of the liver. HCV infection is contracted by contact with the blood or other body fluids of an infected person. Hepatitis due to HCV can result in an acute process where a person is affected for only several months and then the virus is cleared from the body. However, the American Association of Liver Disease estimates that up to 85% of individuals become chronically infected following exposure. HCV disease progression then occurs over a period of 20 to 30 years during which patients are generally asymptomatic, meaning they exhibit no symptoms of the disease. Chronic hepatitis can lead to permanent liver damage, which can result in the development of liver cancer, liver failure or death.

 

It is currently estimated that 170 million people worldwide are chronically infected with HCV with three to four million new HCV infections annually. As of 2001, there were approximately 2.7 million individuals chronically infected with HCV within the United States. According to the National Institutes of Health, or NIH, hepatitis C is responsible for 10,000 to 12,000 deaths each year in the United States. Based upon genetic sequence analysis, HCV can be classified into one of six major classes or genotypes. The genotype 1 strain of HCV is the most common genotype in the United States, Europe and Japan and accounts for 79% of all HCV infections in the United States.

 

According to reports published by Datamonitor, the worldwide market for HCV therapeutics in 2004 was estimated to be $2 billion, and is projected to exceed $4 billion by 2013.

 

The current standard of care for patients with chronic HCV infection is treatment with a combination of long-acting, pegylated forms of interferon alpha administered through weekly injections coupled with daily, oral doses of ribavirin. The duration of treatment for patients infected with non-genotype 1 virus is six months and results in undetectable viral load and normalization of liver function markers in up to 80% of patients receiving a full course of treatment. However, in individuals infected with the genotype 1 virus, the standard of care calls for 12 months of treatment and is successful in only approximately 50% of patients receiving a full course of treatment.

 

Treatment with pegylated interferon and ribavirin is further complicated by significant adverse side effects, including flu-like symptoms, anemia, depression, fatigue, suicidal tendencies and abnormal fetal development. Since chronic hepatitis C infection, with the exception of late-stage disease, is generally asymptomatic, the nature and extent of the treatment-related adverse side effects make patients feel sicker than they were prior to treatment. As a result of these treatment-related adverse side effects, nearly 40% of treated patients require dosage adjustments, and many of these patients may discontinue therapy altogether. In addition, current treatments are administered by injection, which is inconvenient and problematic for patients who are afraid of needles. Therefore, important goals for new HCV therapies are to:

 

    improve efficacy against the genotype 1 virus;

 

    offer a treatment response in patients who have failed an interferon and ribavirin based treatment;

 

    reduce the magnitude of treatment-related adverse side effects; and

 

    offer a more convenient, orally available, treatment option.

 

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We believe the lessons learned from the treatment of HIV infection, specifically the improved antiviral response achieved through the use of combination therapies, are relevant for the treatment of HCV due to its rapid replication and high frequency of mutations. One common approach to the discovery of new therapies to treat chronic hepatitis C focuses on the inhibition of viral proteins essential to the completion of the HCV replication cycle. The two most common of these HCV drug targets are NS5B polymerase and NS3 protease. NS5B polymerase is essential for viral replication, as it is directly involved in creating new copies of the viral RNA genome. NS3 protease is essential for viral protein processing and completion of the viral lifecycle. All of the NS3 inhibitors of which we are aware work by binding to the protein’s active site, thus preventing protein processing. Both NS5B and NS3 inhibitors have demonstrated in clinical trials significant viral load reduction in infected patients. Many experts believe that these drugs, if approved, will need to be used in combination with other drugs in order to improve upon the efficacy obtained with the current standard of care.

 

Achillion Approach: ACH-806

 

ACH-806 (also known as GS 9132) is a novel small molecule potent inhibitor of HCV replication which we identified through our internal research program. We believe ACH-806 has the following benefits:

 

    Novel Mechanism of Action . Based upon extensive virology and biochemistry studies, we have established that the mechanism of action of ACH-806 is novel and involves an interaction with NS3 protease which is distinct from that observed with other known NS3 protease inhibitors. ACH-806 prevents the formation of the replicase complex, a necessary step in viral replication that occurs before copying the viral RNA genome, the step that polymerase inhibitors affect, but after viral protein processing, the step that protease inhibitors affect. Accordingly, we believe this unique mechanism may contribute to the lack of cross resistance between ACH-806 and other HCV inhibitors.

 

    Potency . Data obtained in the standard laboratory assays used to determine anti-HCV activity against the genotype 1 virus demonstrate that ACH-806 has potency in vitro in a range similar to the published data on Boehringer Ingelheim’s protease inhibitor under clinical development, and 14 to 21 times more potency in vitro than either the Schering-Plough or Vertex HCV protease inhibitors under clinical development.

 

    Lack of Cross Resistance . In laboratory studies, ACH-806 has not demonstrated cross resistance to any of the polymerase inhibitors or protease inhibitors of which we are aware and have tested.

 

    Ease of Administration . Based on current animal studies, we believe ACH-806 could be administered orally.

 

    Potential for Combination Treatment . Because of the lack of cross resistance with all other known classes of HCV inhibitors, we believe that ACH-806 is well positioned for evaluation as a treatment for chronic hepatitis C in combination with the current standard of care and/or in combination with other direct acting antivirals.

 

Clinical Development History

 

In the second half of 2005, we initiated a single dose-escalating phase I clinical trial with 20 subjects using a liquid formulation. There were no clinically significant findings in this trial, and we determined that this formulation is not suitable for further clinical trials or commercialization. We then evaluated the pharmacokinetics and safety of a tablet formulation of ACH-806 in a single dose-escalating phase I clinical trial in 20 subjects. We completed this trial in the second quarter of 2006, and results revealed the drug was safe and well tolerated in healthy volunteers. These results are based on a small number of patients and are not necessarily predictive of results in trials with larger and more diverse patient populations. In August 2006, we initiated a multiple dose proof-of-concept clinical trial in HCV-infected patients. A proof-of-concept trial is generally a late-stage phase I or early-stage phase II clinical trial, the objective of which is to demonstrate that the tested drug shows a beneficial effect (e.g., a reduction in viral RNA levels) in human subjects. We expect to complete this trial and have results available in the first quarter of 2007.

 

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As appropriate, based upon the clinical experience gained with ACH-806 in the proof-of-concept clinical trial, our collaborative partner, Gilead Sciences, may conduct phase II and/or phase III clinical trials and will assume financial and operational responsibility for the development of ACH-806 if it chooses to conduct such trials.

 

Preclinical Development History

 

In our preclinical studies, we demonstrated that ACH-806 inhibits HCV replication in cell-based replicon assays that have developed resistance to other HCV protease and polymerase inhibitors.

 

In 2005, we compared the potency of ACH-806 with two other NS3 protease inhibitors currently in clinical development, VX-950, being developed by Vertex, and SCH-503034, being developed by Schering-Plough. Potencies of ACH-806, VX-950 and SCH-503034 for inhibition of HCV replication are represented by the amount of inhibitor required (as measured in nanomoles, or nM) to inhibit 50% of HCV replication in in vitro laboratory tests. A lower nM number represents greater inhibition and potency. Our results demonstrated that, in laboratory testing, ACH-806 is approximately 14-fold more potent than SCH-503034, and approximately 21-fold more potent than VX-950. The following table describes these results:

 

HCV Inhibitor


   Potency (nM)

ACH-806

   14

VX-950

   300

SCH-503034

   200

 

In addition, this compound has demonstrated good oral bioavailability and a favorable safety profile in animals.

 

Back-up Program

 

Based on our experience in the HCV area, and as part of our collaboration with Gilead Sciences, we have developed a series of HCV inhibitors with the following characteristics:

 

    Chemical Structure . The chemical structure is distinct from ACH-806.

 

    Mechanism of Action . Compounds inhibit HCV replication through the same mechanism of action as ACH-806.

 

    Potency . Our compounds display in vitro potency equal to or better than ACH-806.

 

    Ease of Administration . Based on preclinical studies, we believe that these compounds could be administered orally.

 

We are currently conducting late stage preclinical studies on these compounds, and we expect to submit an IND to the FDA in 2007 for one of these compounds.

 

Under the terms of the collaboration with Gilead Sciences, we are responsible for preclinical development, regulatory filing and clinical development of ACH-806 through the completion of the proof-of-concept clinical trial according to a jointly agreed upon research plan. We are also responsible for research activities associated with the identification of a back-up compound until such time as proof-of-concept is achieved with respect to one compound. Research activities prior to demonstration of proof-of-concept will be overseen by a research committee comprised of equal numbers of our representatives and representatives from Gilead Sciences. Gilead Sciences is otherwise responsible for all development and commercialization of compounds, including all regulatory filings and clinical trials after proof-of-concept. Gilead Sciences is responsible for the manufacturing of compounds throughout all stages of development and commercialization. In connection with commercialization of products, we have a one-time option to participate on a limited basis in the marketing effort in the United States.

 

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ACH-702, Anti-MRSA Antibacterial

 

ACH-702 is an internally discovered compound that we are developing as a treatment for serious nosocomial, or hospital-based, bacterial infections. We are currently assessing ACH-702 in IND-enabling preclinical studies to support clinical evaluation of this drug. We expect to submit an IND to the FDA during the first quarter of 2007.

 

Overview of Hospital-Based Antibacterials Market

 

CDC data shows that antibacterial resistance has been increasing dramatically over the past few decades. Antibacterial resistance is most pronounced in the hospital setting, where the heavy use of antibiotics creates an ideal environment for the development of drug resistance. Approximately 70% of nosocomial infections are resistant to at least one antibiotic.

 

One of the most common pathogenic bacteria is a gram-positive bacterium referred to as Staphylococcus aureus , or S. aureus . It can cause serious infections of the skin, bloodstream, bones or joints. In 2002, 57% of S. aureus infections in the hospital were due to infections with strains of S. aureus that were resistant to methicillin, part of a commonly used class of antibiotics. Frequently, these methicillin resistant S . aureus strains, commonly referred to as MRSA, are also resistant to other classes of antibacterials such as cephalosporins and quinolones. Consequently, MRSA is commonly used to refer to multi-drug-resistant bacteria associated with serious infections. The increasing difficulty in treating MRSA and other multi-drug-resistant hospital-based infections has led to higher morbidity and mortality rates, as well as increasing health care expenditures.

 

Historically, the pharmaceutical industry was able to keep pace with the need for new antibacterial drugs. However, since 1968, only two new classes of antibacterials have been brought to market. While alternative treatments are available for MRSA, such as vancomycin, Cubicin (daptomycin), Zyvox (linezolid) and Synercid (dalfopristin + quinupristin), they face one or more of the following limitations: limited potency, lack of a bactericidal, or bacteria-killing, mechanism of action, narrow spectrum of activity, the need for intravenous or injectable administration and adverse side effects.

 

According to an industry report published by Espicom, the 2006 worldwide market for anti-MRSA antibacterials is projected to be approximately $2.0 billion.

 

Achillion Approach: ACH-702

 

We believe ACH-702 has the following benefits:

 

    Broad-Spectrum Potency . ACH-702 has a novel target profile against bacterial DNA replication enzymes and potent broad-spectrum activity. We have established potent activity of ACH-702 against multi-drug-resistant bacteria in a laboratory evaluation of recent clinical isolates obtained from infected patients, as well as in preclinical models of infection. The spectrum of activity includes inhibition of the DNA replication enzymes: gyrase, topoisomerase IV and primase.

 

    Bactericidal Mechanism of Action. ACH-702 has demonstrated bactericidal activity against multi-drug-resistant MRSA. A number of the other drugs currently used to treat MRSA infections are bacteriostatic, meaning they are able to prevent the growth of new bacteria, but have a limited effect on the bacteria existing at the time of treatment.

 

    Dosing. We believe the properties of ACH-702 support potential administration through both intravenous and oral formulations. An orally administered drug would be more convenient for patients and may decrease health care costs by enabling patients to transition their treatment from the hospital to a home setting.

 

Preclinical Development History

 

In preclinical studies, ACH-702 has demonstrated potent antibacterial activity against a number of medically relevant bacteria, including drug-resistant strains such as MRSA and vancomycin-resistant enterococcus. The following table illustrates ACH-702 activity versus MRSA clinical strains, compared to other

 

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marketed antibacterial products. The standard measurement of antibacterial activity is minimum inhibitory concentration, or MIC, meaning the minimum amount of drug required to inhibit complete growth of bacteria (as measured in micrograms per ml, or µg/ml). The lower the MIC, the greater the potency of the compound. In this study, for example, ACH-702 demonstrated potent activity in vitro against three MRSA strains that are resistant to vancomycin and Zyvox (linezolid), which are current standards of care.

 

     MIC (µg/ml)

Compound


   MRSA (F-2121)

   MRSA (F-2128)

   MRSA (F-2137)

ACH-702

   0.12    0.25    0.25

Vancomycin

   8.00    >32.00    2.00

Linezolid

   2.00    2.00    >16.00

 

In late-stage preclinical studies, ACH-702 demonstrated acceptable pharmacokinetic and safety profiles. Potent antibacterial activity has been demonstrated against both sensitive and drug-resistant strains in well-established preclinical infection models.

 

Discovery Programs

 

While pursuing the development of our lead programs in the HIV, HCV and antibacterial areas, we continue to engage in the preclinical development of earlier-stage drug candidates. Currently, our principal early-stage programs are the following:

 

HIV Capsid Program

 

We believe current HIV combination therapies will benefit from discovery and development of therapeutics that inhibit viral proteins not targeted by currently marketed drugs. One such protein is the capsid protein, an essential component for HIV replication. Capsid protein is required for maturation and production of HIV. We have identified small molecule inhibitors that prevent HIV replication through their interactions with the capsid protein. The cornerstone of our research is our exclusive access to the proprietary, three-dimensional structure of capsid protein, and to three-dimensional structures of inhibitors bound to the capsid protein. We have combined this information with our expertise in computational chemistry, medicinal chemistry and virology to design, synthesize and optimize inhibitors of HIV capsid protein. We have demonstrated that our inhibitors prevent HIV replication through interactions with the capsid protein. Our research efforts in this area are supported by an SBIR grant from the NIH.

 

HCV Inhibitor Program

 

Similar to the treatment paradigm in HIV, we believe combination therapy for the treatment of chronic HCV infection will benefit from drugs that inhibit HCV replication through complementary mechanisms of action. We have leveraged our experience in HCV drug discovery to identify inhibitors that are distinct from ACH-806 in their mechanism of action and thus are not subject to our collaboration and exclusive license agreement with Gilead Sciences. In preclinical studies, we have demonstrated that these inhibitors are efficacious against genotype 1 virus, are not cross resistant to ACH-806 and potentially can be administered orally.

 

Drug Discovery and Development Capabilities

 

We have successfully advanced two drug candidates into human clinical trials, with a third drug candidate in late-stage preclinical studies. We discovered two of these drug candidates, ACH-806 and ACH-702, by applying our deep understanding of virology, microbiology and synthetic chemistry. We intend to continue to capitalize on our internal drug discovery and development capabilities to expand our product portfolio.

 

From early lead identification through clinical candidate selection, we have coupled our knowledge base in genomic replication targets with an integrated drug discovery infrastructure to aid in the rapid advancement of our discovery programs.

 

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Target Selection and Assay Development

 

We are focused on addressing unmet medical needs in infectious diseases, with an emphasis on inhibiting viral and bacterial proteins essential for genomic replication. We select targets for our drug discovery programs based upon the relevance of the target to key steps within the viral or bacterial replication cycle, our ability to develop appropriate assays for early assessment of potency, selectivity and safety and confidence in our ability to identify small molecules that can be optimized within a reasonable time period to become drug candidates. We have developed proprietary assays for identification and optimization of small molecule inhibitors of viral and bacterial genomic replication.

 

Compound Synthesis, Hit Identification and Lead Optimization

 

Our focused compound library contains a diverse set of molecules that have been synthesized for the principal purpose of inhibiting genomic replication in viruses and bacteria. We have developed the following discovery tools that enable us to manage our compounds efficiently and advance our discovery programs:

 

    AACP (Achillion Automated Chemistry Platform) is a proprietary software program that facilitates medium and high throughput synthesis of compounds. AACP allows us to synthesize thousands of small molecules in support of our drug discovery programs.

 

    CART (Compound Acquisition and Repository Tracking) is a software tool that streamlines our scientists’ ability to select and acquire compounds for lead identification. CART is integrated with computational chemistry tools and a virtual database of greater than two million small molecules.

 

    CHEM-ACH is data mining software that allows compounds synthesized at Achillion to be cross-referenced against biological activities associated with them. Structure-activity relationships are elaborated with CHEM-ACH, greatly facilitating design and synthesis of compounds for lead optimization.

 

    D2P2 (Drug Design Through Pharmacophore Perception) is a software application which allows our scientists to study interactions between a drug target and its inhibitors in three dimensions. D2P2 has facilitated lead optimization in our HCV program.

 

Preclinical Candidate Selection

 

A cornerstone of our approach to drug discovery and development is the early assessment of the drug-like properties associated with optimized lead compounds. Potency and activity against a given target are necessary but not sufficient predictors of eventual successful clinical development of a new drug. In order to perform an early assessment of the potential for successful development, prior to progression of a compound into late-stage preclinical studies in support of clinical trials, we aggressively evaluate compounds in numerous tests relating to safety, metabolism, pharmacokinetic properties and physical properties associated with the feasibility for an oral formulation.

 

Our Scientists

 

Our employees and advisors have significant preclinical and clinical development expertise. We have over 45 scientists engaged in drug discovery, preclinical drug development and clinical research and regulatory affairs. In the aggregate, members of our drug discovery, preclinical and clinical development team have contributed to the selection and development of more than 80 clinical candidates and 50 marketed products throughout their careers.

 

Competition

 

Our industry is highly competitive and subject to rapid and significant technological change. All of the drugs we are developing, if approved, will compete against existing therapies. In addition, we believe a significant number of drug candidates are currently under development and may become available for the

 

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treatment of HIV infection, chronic hepatitis C and bacterial infections. The key competitive factors affecting the commercial success of these drugs are likely to be efficacy, safety profile, reliability, convenience of dosing, price and reimbursement.

 

Many of our potential competitors, including many of the organizations named below, either alone or with their collaborative partners, have substantially greater financial, technical and human resources than we do and significantly greater experience in the discovery and development of drug candidates, obtaining FDA and other regulatory approvals of products and the commercialization of those products. Accordingly, our competitors may be more successful than we may be in obtaining FDA approval for drugs and achieving widespread market acceptance. Our competitors’ drugs may be more effective, or more effectively marketed and sold, than any drug we may commercialize and may render our drug candidates obsolete or non-competitive before we can recover the expenses of developing and commercializing any of our drug candidates. We anticipate that we will face intense and increasing competition as new drugs enter the market and advanced technologies become available. These organizations may also establish collaborative or licensing relationships with our competitors. Finally, the development of a cure or new treatment methods for the diseases we are targeting could render our drugs non-competitive or obsolete.

 

Elvucitabine, HIV

 

Elvucitabine, if approved, will compete with the NRTIs currently marketed for treatment of HIV infection, including: Epivir (3TC), Retrovir (AZT), Ziagen (abacavir), Combivir (3TC + AZT), Trizivir (3TC + AZT + abacavir) and Epzicom (3TC + abacavir) from GlaxoSmithKline, Hivid (ddC) from Hoffman-La Roche, Emtriva (FTC), Viread (tenofovir) and Truvada (FTC + tenofovir) from Gilead Sciences and Videx EC, Videx (ddI) and Zerit (d4T) from Bristol-Myers Squibb. In addition, elvucitabine may compete with other NRTIs currently under development for HIV by companies such as Avexa, Medivir, Pharmasset and Koronis. Other classes of drugs are also under development for the treatment of HIV infection by companies such as Abbott, Boehringer Ingelheim, Johnson & Johnson, Merck, Panacos, Pfizer, Roche, Schering-Plough, Trimeris and Vertex.

 

ACH-806, HCV

 

ACH-806 (also known as GS 9132), if approved, will compete with drugs currently approved for the treatment of hepatitis C, the interferon-alpha based products from Roche (Pegasys and Roferon-A) or Schering-Plough (Intron-A or Peg-Intron) and the ribavirin based products from Schering-Plough (Rebetrol), Roche (Copegus) or generic versions sold by various companies. In addition, ACH-806 may compete with the interferon and ribavirin based drugs currently in development such as Valeant’s ribavirin analog (Viramidine) and Human Genome Sciences’ Albuferon. Other products are also under development for the treatment of hepatitis C by companies such as Abbott, Anadys, Arrow Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Human Genome Sciences, Idenix Pharmaceuticals, Intermune, Johnson & Johnson, Medivir, Merck, Novartis, Panacos, Pfizer, Pharmasset, Roche, Schering-Plough, Trimeris, Valeant and Vertex.

 

ACH-702, Anti-MRSA Antibiotic

 

ACH-702, if approved, will compete with drugs currently marketed for the treatment of serious gram-positive nosocomial infections including: vancomycin (multiple generic forms), Cubicin (daptomycin) by Cubist Pharmaceuticals, Zyvox (linezolid) by Pfizer and Synercid (dalfopristin + quinupristin) by King Pharmaceuticals. In addition, ACH-702 may compete with other drugs currently under development for the treatment of nosocomial gram-positive infections including: dalbavancin in development by Pfizer, telavancin from Theravance, oritavancin by Intermune, doripenem by Johnson & Johnson, ceftobiprole by Basilea and Johnson & Johnson, iclaprim by Arpida and garenoxacin by Schering-Plough. We may also compete with the following companies that have a strategic interest in the discovery, development and marketing of drugs for the treatment of bacterial infections: Abbott, Aventis, Bristol-Myers Squibb, Cubist, GlaxoSmithKline, Merck, Novartis, Replidyne, Roche and Wyeth.

 

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Intellectual Property

 

Our policy is to pursue patents, developed internally and licensed from third parties, and other means to otherwise protect our technology, inventions and improvements that are commercially important to the development of our business. We also rely on trade secrets that may be important to the development of our business.

 

Our success will depend significantly on our ability to:

 

    obtain and maintain patent and other proprietary protection for the technology, inventions and improvements we consider important to our business;

 

    defend our patents;

 

    preserve the confidentiality of our trade secrets; and

 

    operate without infringing the patents and proprietary rights of third parties.

 

Our elvucitabine patent portfolio currently consists of seven issued U.S. patents, nine associated issued non-U.S. patents, 25 associated pending non-U.S. patent applications, one pending U.S. non-provisional application and two pending PCT applications. We either own or hold exclusive worldwide sublicenses from Vion Pharmaceuticals of patents owned by Yale University or exclusive worldwide licenses from Emory University to these patents and patent applications. The issued patents and patent applications, if issued, will expire between 2013 and 2026. The issued U.S. patents contain claims directed to the compound, method of use and process for synthesis of elvucitabine, which claims expire in 2013, 2013 to 2014, and 2023, respectively. The issued foreign patents contain claims directed to the method of use of elvucitabine and expire in 2014.

 

Our hepatitis C patent portfolio currently consists of two U.S. provisional patent applications, nine pending U.S. non-provisional applications, one associated issued non-U.S. patent, 68 associated pending non-U.S. patent applications and five pending PCT applications. These patent applications, if issued, will expire between 2023 and 2026. The patent applications contain claims directed to compounds, method of use, process for synthesis, mechanism of action and research assays.

 

In connection with our November 2004 collaboration with Gilead Sciences, we granted a worldwide exclusive license to Gilead Sciences for past, present and future patents, patent applications and patent filings with claims directed to ACH-806, compounds chemically related to ACH-806, any additional compounds which inhibit HCV via a mechanism similar to that of ACH-806, and intellectual property relating to the mechanism of action of ACH-806. Gilead Sciences has a right to present and discuss with us its capabilities to participate in the development and commercialization of new HCV compounds.

 

In addition, we have obtained non-exclusive licenses to HCV drug discovery patents and patent applications owned by Chiron Corporation, Apath, L.L.C. and ReBlikon, GmbH.

 

Our antibacterial patent portfolio currently consists of six pending U.S. patent applications, one pending U.S. provisional patent application, 14 associated pending non-U.S. applications and five pending international patent applications filed under the Patent Cooperation Treaty. These patent applications, if issued, will expire between 2024 and 2026. The patent applications contain claims directed to compounds, method of use, process for synthesis and mechanism of action.

 

Our HIV capsid patent portfolio currently consists of four pending U.S. patent applications, one pending international patent application filed under the Patent Cooperation Treaty and ten associated non-U.S. patent filings. These patent applications, if issued, will expire between 2022 and 2026. We have obtained an exclusive worldwide license to these patent applications from the University of Maryland Baltimore County.

 

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Collaborations and Licenses

 

Gilead Sciences

 

In November 2004, we entered into a research collaboration and license agreement with Gilead Sciences, Inc. pursuant to which we agreed to collaborate exclusively with Gilead Sciences throughout the world to develop and commercialize compounds for the treatment of chronic hepatitis C, including ACH-806 (also known as GS 9132), which inhibits HCV replication through a novel mechanism of action involving HCV protease. After proof-of-concept, if requested by Gilead Sciences, we may elect to assume responsibility for additional discovery activities on terms to be negotiated with Gilead Sciences at such time. We will perform preclinical development and clinical development through the completion of a proof-of-concept clinical trial in HCV patients according to a jointly-agreed upon research plan. Gilead Sciences will be responsible for manufacturing and formulation activities. Research and development activities prior to proof-of-concept will be overseen by a research committee comprised of equal numbers of our representatives and representatives from Gilead Sciences. The research committee shall agree upon a budget for the research program, and the parties will equally share such costs. In addition, the parties may agree at any time to increase or decrease the research budget. Through June 30, 2006, the parties have expended an aggregate of $17.9 million on research and development activities. Prior to proof-of-concept, any disputes within the research committee that cannot be resolved between designated executives of each party will be resolved by Gilead Sciences.

 

Gilead Sciences is otherwise responsible for all development and commercialization of compounds, including all regulatory filings and clinical trials after proof-of-concept. Gilead Sciences is responsible for the manufacturing of compounds throughout all stages of development and commercialization. Gilead Sciences has agreed under the agreement to use reasonably diligent efforts to develop and commercialize at least one compound in each of the United States, Japan, Germany, France, Italy, Spain and the United Kingdom. In connection with Gilead Sciences’ exclusive right to market and commercialize products, we have a one-time option to participate on a limited basis in the marketing effort in the United States. Pursuant to the terms of the collaboration agreement, Gilead Sciences must provide us with notice following commencement of a phase III clinical trial and prior to filing of an NDA. We must then notify Gilead Sciences whether we intend to designate field-based personnel to support their commercial activities within the United States. Following Gilead Sciences’ receipt of our notice, the parties must negotiate in good faith to determine the number of Achillion field-based personnel and the manner of their participation. These field-based personnel will operate under the supervision of Gilead Sciences and receive training at a similar level to equivalent Gilead Sciences field-based personnel. We bear the costs associated with the commercial participation of our field-based personnel; provided, however, that Gilead Sciences shall bear the expense of training. Our participation does not change the amount of any royalty payments Gilead Sciences is obligated to pay us on net sales of any drugs pursuant to our collaboration agreement. Under the agreement, Gilead Sciences is required to make royalty payments, if any, to us until the end of the royalty term, which is the earlier of (i) ten years following the date of the first commercial sale of a compound or (ii) the expiration of the last Achillion patent or patent owned jointly with Gilead Sciences.

 

We received $10.0 million from Gilead Sciences upon the execution of the agreement, consisting of license fees and an equity investment, and could receive up to $157.5 million in development, regulatory and sales milestone payments, assuming the successful simultaneous development of a lead and back-up compound, as well as royalties on net sales of products. We will share equally with Gilead Sciences all costs of the research program through proof-of-concept, subject to an agreed-upon cap. Thereafter, Gilead Sciences will assume all costs for development and commercialization of compounds, other than a portion of patent prosecution costs that we have agreed to pay.

 

The agreement will expire on the last to expire royalty term. In addition, Gilead Sciences may terminate the agreement for any reason after the earlier of (i) proof-of-concept or (ii) November 24, 2006, by providing us with 120 days notice. Either party has the right to terminate for material breach, though we may terminate for Gilead Sciences’ breach only on a market-by-market basis and, if applicable, a product-by-product basis.

 

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Vion Pharmaceuticals/Yale University

 

In February 2000, we entered into a license agreement with Vion Pharmaceuticals, pursuant to which we obtained a worldwide exclusive sublicense from Vion on the composition of matter and use of elvucitabine. Vion’s license rights were granted to it by Yale, and Yale is a party with respect to certain provisions of this agreement. This license covers the use of elvucitabine alone, as a pharmaceutical composition containing elvucitabine alone, or its use as monotherapy to treat HIV. Yale has retained rights to utilize the intellectual property licensed by this agreement for its own noncommercial purposes. Pursuant to the agreement, we issued 6,250 shares of our common stock to each of Vion and Yale. In addition, pursuant to an amendment to the agreement entered into in January 2002, we granted options to purchase 7,500 shares of our common stock to each of Vion and Yale. Through June 30, 2006, we have made aggregate payments of $35,000 to Yale under this agreement, including a $10,000 initial license fee and a $25,000 development milestone payment. Under the terms of the agreement, we may also be required to make additional milestone payments to Yale of up to an aggregate of $850,000 for each licensed product based on the achievement of specified development and regulatory approval milestones. We are also required to pay Yale specified royalties on net product sales and a specified share of sublicensing fees that we receive under any sublicenses that we grant.

 

This agreement will remain in effect until the later of 15 years after the date of the agreement or the expiration of the last-to-expire licensed patent, which is currently scheduled to expire June 14, 2016, unless earlier terminated. We may terminate this agreement for convenience upon 30 days notice. The agreement may also be terminated by Vion upon 30 days notice of our uncured material breach of the agreement, including, among other things, nonpayment of any amounts owed under the agreement, our failure to provide reasonable assistance in connection with the enforcement of patents by Vion and Yale, upon 60 days notice of our uncured failure to meet specified development and marketing diligence requirements and upon notice of specified bankruptcy and insolvency events involving us. The agreement also provides that if the underlying license agreement between Vion and Yale terminates, our agreement with Vion will also terminate, provided that, if Yale terminates the underlying license agreement between Yale and Vion for cause, Yale has agreed to enter into a direct license with us on terms substantially similar to our agreement with Vion.

 

Emory University

 

In July 2002, we entered into a license agreement with Emory University, pursuant to which we obtained a worldwide exclusive license under specified licensed patents to use elvucitabine in combination with other antivirals. Under the license, Emory retains a right to use the intellectual property for educational and research purposes only and also retains the right to approve sublicensees under specified circumstances. Through June 30, 2006, we have made aggregate payments of $150,000 to Emory under this agreement, including an initial license fee of $100,000 and a development milestone payment of $50,000. We may also be required to make additional payments of up to an aggregate of $400,000 based on the achievement of specified development and regulatory approval milestones. Under this agreement, we are also required to pay Emory specified royalties on net product sales and a specified share of sublicensing fees that we receive under any sublicenses that we grant.

 

This agreement will remain in effect until the expiration of the last-to-expire licensed patent, which is currently scheduled to expire on January 27, 2015, unless earlier terminated. Each party has the right to terminate this agreement upon 60 days notice for an uncured material breach. Emory may terminate this agreement upon 60 days notice of specified bankruptcy and insolvency events involving us. We may terminate this agreement for convenience upon 60 days notice. Even after termination, we may continue selling licensed products for three months so long as royalties and all other monies owed are paid to Emory.

 

University of Maryland Baltimore County

 

In November 2002, we entered into a license agreement with the University of Maryland Baltimore County, or UMBC, under which we obtained an exclusive license from UMBC for drug discovery technology that is useful for screening and identifying compounds that bind to the HIV capsid protein. Through June 30,

 

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2006, we have made aggregate payments of $22,500 to UMBC under this agreement, including an initial license fee of $7,500 and annual license payments totaling $15,000. If we have not achieved a specified development milestone prior to November 15, 2006, which we currently do not expect to achieve, we will be required to make an additional annual license payment of $10,000 for the year beginning November 15, 2005 and each year thereafter until the milestone is met or this agreement is terminated. We may also be required to make additional payments of up to an aggregate of $650,000 based on the achievement of specified development and regulatory approval milestones. In addition, we are required to pay UMBC specified royalties on net product sales and a specified share of sublicensing fees that we receive under any sublicenses that we grant.

 

This agreement will remain in effect until the expiration of the last-to-expire licensed patent, unless earlier terminated. There are currently no issued patents under this agreement. Each party has the right to terminate the agreement upon 60 days notice for an uncured material breach, and we may terminate this agreement for convenience upon 60 days notice.

 

Manufacturing and Supply

 

We currently rely on contract manufacturers to produce drug substances and drug products required for our clinical trials under current good manufacturing practices, with oversight by our internal managers. We plan to continue to rely upon contract manufacturers and collaboration partners to manufacture commercial quantities of our drug candidates if and when approved for marketing by the FDA. We currently rely on a single manufacturer for the preclinical or clinical supplies of each of our drug candidates and do not currently have relationships for redundant supply or a second source for any of our drug candidates. We believe that there are alternate sources of supply that can satisfy our clinical trial requirements without significant delay or material additional costs.

 

Sales and Marketing

 

We intend to establish our own sales and marketing capabilities if and when we obtain regulatory approval of our drug candidates. In North America and Western Europe, patients in the markets for our drug candidates are largely managed by medical specialists in the areas of infectious diseases, hepatology and gastroenterology. Historically, companies have experienced substantial commercial success through the deployment of these specialized sales forces which can address a majority of key prescribers, particularly within the infectious disease marketplace. Therefore, we expect to utilize a specialized sales force in North America for the sales and marketing of drug candidates that we may successfully develop. We currently have no marketing, sales or distribution capabilities. In order to participate in the commercialization of any of our drugs, we must develop these capabilities on our own or in collaboration with third parties. We may also choose to hire a third party to provide sales personnel instead of developing our own staff. Pursuant to our collaboration agreement with Gilead Sciences, we have granted Gilead Sciences worldwide commercialization rights for certain of our HCV compounds, including ACH-806. However, we have the option to participate on a limited basis in marketing efforts in the United States.

 

Outside of North America, and in situations or markets where a more favorable return may be realized through licensing commercial rights to a third party, we may license a portion or all of our commercial rights in a territory to a third party in exchange for one or more of the following: up-front payments, research funding, development funding, milestone payments and royalties on drug sales.

 

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Regulatory Matters

 

Government Regulation and Product Approval

 

Government authorities in the United States, at the federal, state and local level, and other countries extensively regulate, among other things, the research, development, testing, manufacture, labeling, packaging, promotion, storage, advertising, distribution, marketing and export and import of products such as those we are developing. Our drugs must be approved by FDA through the new drug application, or NDA, process before they may be legally marketed in the United States.

 

In the United States, the FDA regulates drugs under the Federal Food, Drug and Cosmetic Act, or FDCA, and implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state, local, and foreign statutes and regulations require the expenditure of substantial time and financial resources. Failure to comply with the applicable United States requirements at any time during the product development process, approval process or after approval, may subject an applicant 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, a clinical hold, warning letters, product recalls, product seizures, total or partial suspension of production or distribution injunctions, fines, civil penalties or criminal prosecution. Any agency or judicial enforcement action could have a material adverse effect on us. The process required by the FDA before a drug may be marketed in the United States generally involves the following:

 

    completion of preclinical laboratory tests, animal studies and formulation studies according to Good Laboratory Practices;

 

    submission of an IND, which must become effective before human clinical trials may begin;

 

    performance of adequate and well-controlled human clinical trials according to Good Clinical Practices to establish the safety and efficacy of the proposed drug for its intended use;

 

    submission to the FDA of an NDA;

 

    satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is produced to assess compliance with current good manufacturing practice, or cGMP, to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity; and

 

    FDA review and approval of the NDA.

 

United States Drug Development Process

 

Once a pharmaceutical candidate is identified for development it enters the preclinical testing stage. Preclinical tests include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies. An IND sponsor must submit the results of the preclinical tests, together with manufacturing information and analytical data, to the FDA as part of the IND. Some preclinical or nonclinical testing may continue even after the IND is submitted. In addition to including the results of the preclinical studies, the IND will also include a protocol detailing, among other things, the objectives of the first phase of the clinical trial, the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated, if the first phase lends itself to an efficacy evaluation. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions about the conduct of the trial. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin.

 

All clinical trials must be conducted under the supervision of one or more qualified investigators in accordance with good clinical practice regulations. These regulations include the requirement that all research subjects provide informed consent. Further, an institutional review board, or IRB, at each institution participating in the clinical trial must review and approve the plan for any clinical trial before it commences at that institution.

 

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Each new clinical protocol must be submitted to the IND for FDA review, and to the IRBs for approval. Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and more frequently if adverse events or other certain types of other changes occur.

 

Human clinical trials are typically conducted in three sequential phases that may overlap or be combined:

 

    Phase I: The drug is initially introduced into healthy human subjects or patients with the disease and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion. In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.

 

    Phase II: Involves studies in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage.

 

    Phase III: Clinical trials are undertaken to further evaluate dosage, clinical efficacy and safety in an expanded patient population at geographically dispersed clinical study sites. These studies are intended to establish the overall risk-benefit ratio of the product and provide, if appropriate, an adequate basis for product labeling.

 

Phase I, phase II, and phase III testing may not be completed successfully within any specified period, if at all. The FDA or an IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk.

 

Concurrent with clinical trials, companies usually complete additional animal studies and must also must develop additional information about the chemistry and physical characteristics of the drug and finalize a process for manufacturing the product in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the drug candidate and, among other things, the manufacturer must develop methods for testing the identity, strength, quality and purity of the final drug. Additionally, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the drug candidate does not undergo unacceptable deterioration over its shelf life.

 

U.S. Review and Approval Processes

 

The results of product development, preclinical studies and clinical studies, along with descriptions of the manufacturing process, analytical tests conducted on the chemistry of the drug, results of chemical studies and other relevant information are submitted to the FDA as part of an NDA requesting approval to market the product. The FDA reviews all NDAs submitted to ensure that they are sufficiently complete for substantive review before it accepts them for filing. The FDA may request additional information rather than accept a NDA for filing. In this event, the NDA must be resubmitted with the additional information. The resubmitted application also is subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review. The submission of an NDA is subject to the payment of user fees; a waiver of such fees may be obtained under certain limited circumstances. The approval process is lengthy and difficult and the FDA may refuse to approve an NDA if the applicable regulatory criteria are not satisfied or may require additional clinical or other data and information. Even if such data and information is submitted, the FDA may ultimately decide that the NDA does not satisfy the criteria for approval. The FDA reviews an NDA to determine, among other things, whether a product is safe and effective for its intended use and whether its manufacturing is cGMP-compliant to assure and preserve the product’s identity, strength, quality and purity. Before approving an NDA, the FDA will inspect the facility or facilities where the product is manufactured.

 

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NDAs receive either standard or priority review. A drug representing a significant improvement in treatment, prevention or diagnosis of disease may receive priority review. In addition, products studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may receive accelerated approval and may be approved on the basis of adequate and well-controlled clinical trials establishing that the drug product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity. As a condition of approval, the FDA may require that a sponsor of a drug receiving accelerated approval perform adequate and well-controlled post-marketing clinical trials. Priority review and accelerated approval do not change the standards for approval, but may expedite the approval process.

 

Pediatric Research Equity Act and Pediatric Exclusivity

 

The Pediatric Research Equity Act of 2003 (PREA), codified as section 505B of the FDCA, provides the FDA with authority to require NDAs or NDA supplements for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration to include pediatric assessments in all relevant pediatric populations. The FDA Modernization Act of 1997 included a pediatric exclusivity provision, codified as section 505A of the FDCA that was extended by the Best Pharmaceuticals for Children Act of 2002. Pediatric exclusivity is designed to provide a voluntary incentive to manufacturers to conduct research about the safety of their products in children. Pediatric exclusivity, if granted, provides an additional six months of market exclusivity in the United States to any patent or non-patent market exclusivity in place for new or currently marketed drugs. Both provisions expire on October 1, 2007, and may not be reauthorized.

 

PREA requirements. PREA requires new drug applications (NDAs) and biologics licensing applications (BLAs) (or supplements to applications) for a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration to contain a pediatric assessment, unless the applicant has obtained a waiver or deferral, with data adequate to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the drug is safe and effective. Such assessments may require separate safety and effectiveness studies in all relevant pediatric populations including data gathered using appropriate formulations for each age group for which an assessment is required. If pediatric studies are required, in order to obtain six months of pediatric exclusivity under section 505A, the applicant must obtain a Written Request from FDA offering the opportunity to qualify for pediatric exclusivity under section 505A before submitting the required studies under section 505B, and must also comply with all the requirements of section 505A. Section 505B further authorizes FDA, after providing written notice and the opportunity to meet, to require holders of approved NDAs to submit pediatric assessments for drugs that are used by many children for the labeled indications and inadequate labeling that could pose significant risks; or that represent a significant improvement over existing pediatric therapies. However, no pediatric assessment for a marketed drug may be required unless a Written Request offering the opportunity to qualify for pediatric exclusivity under section 505A of the FDCA has been made by the agency.

 

Pediatric Exclusivity. Under Section 505A of the Federal Food, Drug, and Cosmetic Act, six months of market exclusivity may be granted in exchange for the voluntary completion of pediatric studies in accordance with an FDA-issued “Written Request.” The FDA may issue a Written Request for studies on unapproved or approved indications, where it determines that information relating to the use of a drug in a pediatric population, or part of the pediatric population, may produce health benefits in that population. We have not requested or received a Written Request for such pediatric studies, although we may ask the FDA to issue a Written Request for such studies in the future. To receive the six-month pediatric market exclusivity, we would have to receive a Written Request from the FDA, and conduct the requested studies and submit reports of the studies in accordance with a written agreement with the FDA. If we receive a Written Request, but do not have a written agreement with FDA regarding the conduct of the studies, the studies must fairly respond to the Written Request, have been conducted in accordance with commonly accepted scientific principles and protocols, and meet filing requirements. There is no guarantee that the FDA will issue a Written Request for such studies or accept the reports of the studies.

 

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Post-approval Requirements

 

Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory standards is not maintained or if problems occur after the product reaches the market. After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further FDA review and approval. In addition, the FDA may require testing and surveillance programs to monitor the effect of approved products that have been commercialized, and the FDA has the power to prevent or limit further marketing of a product based on the results of these post-marketing programs.

 

Any drug products manufactured or distributed by us pursuant to FDA approvals are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse experiences with the drug, providing the FDA with updated safety and efficacy information, drug sampling and distribution requirements, notifying the FDA and gaining its approval of certain manufacturing or labeling changes, complying with certain electronic records and signature requirements, and complying with FDA promotion and advertising requirements. Drug manufacturers and 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 cGMP and other laws.

 

We rely, and expect to continue to rely, on third parties for the production of clinical and commercial quantities of our products. Future FDA and state inspections may identify compliance issues at the facilities of our contract manufacturers that may disrupt production or distribution, or require substantial resources to correct.

 

From time to time, legislation is drafted, introduced and passed in Congress that could significantly change the statutory provisions governing the approval, manufacturing and marketing of products regulated by the FDA. In addition, FDA regulations and guidance are often revised or reinterpreted by the agency in ways that may significantly affect our business and our products. It is impossible to predict whether legislative changes will be enacted, or FDA regulations, guidance or interpretations changed or what the impact of such changes, if any, may be.

 

Foreign Regulation

 

In addition to regulations in the United States, we will be subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of our products. Whether or not we obtain FDA approval for a product, we must obtain approval of a product by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the product in those countries. The approval process varies from country to country and the time may be longer or shorter than that required for FDA approval. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country to country.

 

Under European Union regulatory systems, we may submit marketing authorization applications either under a centralized or decentralized procedure. The centralized procedure, which is compulsory for medicines produced by certain biotechnological processes and optional for those which are highly innovative, provides for the grant of a single marketing authorization that is valid for all European Union member states. For drugs without approval in any Member State, the decentralized procedure provides for approval by one or more other, or concerned, Member States of an assessment of an application performed by one Member State, known as the reference Member State. Under this procedure, an applicant submits an application, or dossier, and related materials (draft summary of product characteristics, draft labeling and package leaflet) to the reference Member State and concerned Member States. The reference Member State prepares a draft assessment and drafts of the related materials within 120 days after receipt of a valid application. Within 90 days of receiving the reference Member State’s assessment report, each concerned Member State must decide whether to approve the assessment report and related materials. If a Member State cannot approve the assessment report and related materials on the grounds of potential serious risk to public health, the disputed points may eventually be referred to the European Commission, whose decision is binding on all Member States.

 

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Reimbursement

 

Sales of pharmaceutical products depend in significant part on the availability of third-party reimbursement. It is time consuming and expensive for us to seek reimbursement from third-party payors. Reimbursement may not be available or sufficient to allow us to sell our products on a competitive and profitable basis.

 

The passage of the Medicare Prescription Drug and Modernization Act of 2003, or the MMA, imposes new requirements for the distribution and pricing of prescription drugs for Medicare beneficiaries, which may affect the marketing of our products. The MMA also introduced a new reimbursement methodology, part of which went into effect in 2004. At this point, it is not clear what effect the MMA will have on the prices paid for currently approved drugs and the pricing options for new drugs approved after January 1, 2006. Moreover, while the MMA applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own payment rates. Any reduction in payment that results from the MMA may result in a similar reduction in payments from non-governmental payors.

 

In addition, in some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing vary widely from country to country. For example, the European Union provides options for its member states to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. A member state may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market.

 

We expect that there will continue to be a number of federal and state proposals to implement governmental pricing controls. While we cannot predict whether such legislative or regulatory proposals will be adopted, the adoption of such proposals could have a material adverse effect on our business, financial condition and profitability.

 

Employees

 

As of September 15, 2006, we had 63 employees, 26 of whom hold doctoral degrees. Approximately 50 of our employees are engaged in research and development, with the remainder engaged in administration, finance and business development functions. We believe our relations with our employees are good.

 

Property and Facilities

 

We are currently leasing approximately 37,000 square feet of laboratory and office space in New Haven, Connecticut, which we occupy under a ten-year lease expiring in 2010. We believe our existing facilities are adequate for our current needs and that additional space will be available in the future on commercially reasonable terms as needed.

 

Legal Proceedings

 

We are not currently subject to any material legal proceedings.

 

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MANAGEMENT

 

The following table sets forth our executive officers and directors, their ages and the positions they held as of September 15, 2006.

 

Name


   Age

  

Position


Michael D. Kishbauch

   57    Director, President and Chief Executive Officer

Milind S. Deshpande, Ph.D.

   50    Senior Vice President and Chief Scientific Officer

John C. Pottage, Jr., M.D.

   53    Senior Vice President and Chief Medical Officer

Mary Kay Fenton

   42    Vice President and Chief Financial Officer

Gautam Shah, Ph.D.

   50    Senior Vice President and Chief Compliance Officer

Jason Fisherman, M.D. (3)

   50    Director

Jean-Francois Formela, M.D. (1)

   50    Director

James Garvey (1)(3)

   59    Director

Michael Grey (2)

   53    Director

Stefan Ryser, Ph.D. (1)(2)

   46    Director

David Scheer (3)

   53    Director

Christopher White (2)

   41    Director

(1) Member of the Compensation Committee
(2) Member of the Audit Committee
(3) Member of the Nominating and Corporate Governance Committee

 

Executive Officers and Directors

 

Michael D. Kishbauch, President and Chief Executive Officer . Prior to joining Achillion in July 2004 as our President and Chief Executive Officer, Mr. Kishbauch founded and served as President and Chief Executive Officer from September 2000 to July 2004 of OraPharma, Inc., a publicly traded, commercial-stage pharmaceutical company focused on oral health care, which was acquired by Johnson & Johnson in 2003. Prior to OraPharma, Inc., Mr. Kishbauch held senior management positions with MedImmune, Inc. Mr. Kishbauch is a director of ARIAD Pharmaceuticals, Inc. Mr. Kishbauch holds an M.B.A. from the Wharton School of the University of Pennsylvania and a B.A. in biology from Wesleyan University.

 

Milind S. Deshpande, Ph.D, Senior Vice President and Chief Scientific Officer. Dr. Deshpande joined Achillion in September 2001 as Vice President of Chemistry, was named head of drug discovery in April 2002, Senior Vice President of Drug Discovery in December 2002 and Senior Vice President and Chief Scientific Officer in December 2004. Prior to joining Achillion, Dr. Deshpande was Associate Director of Lead Discovery and Early Discovery Chemistry at the Pharmaceutical Research Institute at Bristol-Myers Squibb from 1991 to 2001, where he managed the identification of new clinical candidates to treat infectious and neurological diseases. From 1988 to 1991, he held a faculty position at Boston University Medical School. Dr. Deshpande received his Ph.D. in Organic Chemistry from Ohio University, following his undergraduate education in India.

 

John C. Pottage, Jr., M.D., Senior Vice President and Chief Medical Officer . Dr. Pottage joined Achillion in May 2002. Prior to Achillion, Dr. Pottage was Medical Director of Antivirals at Vertex Pharmaceuticals. During this time he also served as an associate attending physician at the Tufts New England Medical Center in Boston. From 1984 to 1998, Dr. Pottage was a faculty member at Rush Medical College in Chicago, where he held the position of Associate Professor, and also served as the Medical Director of the Outpatient HIV Clinic at Rush-Presbyterian-St. Luke’s Medical Center. Dr. Pottage is a graduate of St. Louis University School of Medicine and Colgate University.

 

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Mary Kay Fenton, Vice President and Chief Financial Officer. Ms. Fenton, a certified public accountant, has led Achillion’s financial function since October 2000. From 1991 to 2000, Ms. Fenton held various positions within the Technology Industry Group at PricewaterhouseCoopers LLP, most recently as Senior Manager responsible for the life sciences practice in Connecticut. Prior to 1991, Ms. Fenton was an economic development associate in the nonprofit sector. Ms. Fenton holds an M.B.A. in Finance from the Graduate School of Business at the University of Connecticut and an A.B. in Economics from the College of the Holy Cross.

 

Gautam Shah, Ph.D., Senior Vice President and Chief Compliance Officer. Dr. Shah joined Achillion in May 2004 as Vice President of Regulatory Affairs and was named Senior Vice President and Chief Compliance Officer in September 2006. Prior to joining Achillion, he was Senior Director of Regulatory Affairs with Sepracor from February 2003 to May 2004. Prior to Sepracor, Dr. Shah was in the Regulatory Affairs Group of Bayer Health Care. Before Bayer, he held positions of increasing responsibilities at Pfizer Inc. in the area of Product and Process Development. Dr. Shah holds a doctoral degree in Pharmaceutics from the University of Illinois, as well as a Master’s degree in Medicinal Chemistry and a Bachelor’s degree in Pharmacy.

 

Jason S. Fisherman, M.D. , Director . Dr. Fisherman has served as a director of Achillion since March 2000. Dr. Fisherman is a Senior Vice President of Advent International Corporation, a global private equity firm where he specializes in biotechnology and emerging pharmaceutical investments, which he joined in 1996. From 1991 to 1994, Dr. Fisherman served as Senior Director of Medical Research for Enzon, Inc., a biopharmaceutical company, and previously managed the clinical development of a number of oncology drugs at the National Cancer Institute. Dr. Fisherman is currently a director of several private healthcare companies. Dr. Fisherman received his B.A. from Yale University, his M.D. from the University of Pennsylvania and his M.B.A. from the Wharton School of the University of Pennsylvania.

 

Jean-Francois Formela, M.D. , Director . Dr. Formela has served as a director of Achillion since January 2000. Dr. Formela is a Senior Partner of Atlas Venture, which he joined in September 1993. Previously, he was Senior Director, Medical Marketing and Scientific Affairs at Schering-Plough, a pharmaceutical company, in the United States. As a medical doctor, Dr. Formela practiced emergency medicine at Necker University Hospital in Paris. Dr. Formela serves on the Board of Directors of ARCA Discovery, Inc. Cellzome AG, Compound Therapeutics, Inc., NxStage Medical, Inc., Resolvyx Pharmaceuticals, Inc. and SGX Pharmaceuticals, Inc. Dr. Formela holds an M.D. from Paris University School of Medicine and an M.B.A. from Columbia Business School.

 

James Garvey, Director. Mr. Garvey has served as a director of Achillion since March 2001. Mr. Garvey joined SV Life Sciences Advisers, LLC, or SVLS (formerly Schroder Ventures Life Sciences Advisers, Inc.), a venture capital firm, in May 1995 and currently serves as the Chief Executive Officer and Managing Partner of SVLS. Prior to joining SVLS, Mr. Garvey was Managing Director for the Venture Capital division of Allstate Corporation, preceded by managing Allstate’s healthcare investment activity. He has held several senior management positions in companies with multinational operations including Kendall (Tyco) and Millipore. He was also President/CEO of start-ups Allegheny International Medical Technology and National Teledata. Mr. Garvey currently serves on the board of directors of CardioFocus, CHF Solutions, Cellutions, NeoVista and Sunrise “At Home”. Mr. Garvey received a B.S. degree from Northern Illinois University in 1969.

 

Michael Grey, Director. Mr. Grey has served as a director of Achillion since November 2001. Since January 2005, he has served as President and Chief Executive Officer of SGX Pharmaceuticals (formerly Structural GenomiX, Inc.), a biotechnology company, where he previously served as President from June 2003 to January 2005 and as Chief Business Officer from April 2001 until June 2003. Between December 1998 and April 2001, he served as a director of Trega Biosciences, Inc., a biopharmaceutical company acquired by Lion bioscience AG in 2001. Prior to joining Trega, from November 1994 to August 1998, Mr. Grey served as President of BioChem Therapeutics, Inc., a division of BioChem Pharma, Inc., a pharmaceutical company. During 1994, Mr. Grey served as President and Chief Operating Officer of Ansan, Inc., a biopharmaceutical company. From 1974 to 1993, Mr. Grey served in various roles with Glaxo, Inc. and Glaxo Holdings, plc, a pharmaceutical company, culminating in his position as Vice President, Corporate Development. Mr. Grey also serves on the

 

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Board of Directors of IDM Pharma, Inc. (formerly known as Epimmune Inc.) and Biomarin Pharmaceutical, Inc. Mr. Grey received a B.Sc. in Chemistry from the University of Nottingham, United Kingdom.

 

Stefan Ryser, Ph.D., Director . Dr. Ryser has served as a director of Achillion since November 2001. Since April 2000, Dr. Ryser has served as founding partner of Bear Stearns Health Innoventures L.P., a venture capital fund. From 1998 to 2000, Dr. Ryser was co-founder and managing partner of International Biomedicine Management Partners, a $70 million biotech venture fund. From January 1989 until December 1997, Dr. Ryser held various positions at F. Hoffmann-La Roche Ltd., a pharmaceutical company, including Scientific Assistant to the President of Global Research and Development. From January 1991 until December 1997, Dr. Ryser served as a member of the Brussels-based senior advisory group of EuropaBio, a European biotechnology organization. Dr. Ryser is a director of Telik, Inc., Raven Biotechnologies, Inc. and TolerRx, Inc. Dr. Ryser holds a Ph.D. degree in molecular biology and a B.S. in biochemistry from the University of Basel.

 

David I. Scheer, Director . Mr. Scheer has served as a director of Achillion since August 1998. Since 1981, Mr. Scheer has been President of Scheer & Company, Inc., a firm that provides corporate strategic advisory services, including with respect to corporate alliances, licensing arrangements, divestments and mergers and acquisitions, to publicly- and privately-held companies, focusing on companies in the life sciences industry. Mr. Scheer is a director and Chairman of the Board of Tengion, Inc. and Aegerion Pharmaceuticals, Inc. Mr. Scheer is also a member of the Advisory Board to the Harvard Malaria Initiative and to the Leadership Council for the Harvard School of Public Health. Mr. Scheer received an A.B., cum laude , from Harvard College and an M.S. from Yale University.

 

Christopher A. White, Director . Mr. White has served as a director of Achillion since December 2003. Mr. White has served as Chief of Staff of Cowen and Company, LLC since December 2005 and as Chief Administrative Officer of Cowen and Company, LLC since June 2006. Mr. White has been the Vice President of Cowen Group, Inc. since its formation in February 2006. Previously, Mr. White served in the Merchant Banking Division of Cowen and Company, LLC, from 2003 to December 2005. Prior to joining the Merchant Banking Division, Mr. White served in the Equity Capital Markets Group of Cowen and Company, LLC where he covered the technology and consumer sectors. Prior to Cowen and Company, LLC, Mr. White worked at Salomon Smith Barney in the Equity Capital Markets Group. In addition, Mr. White has over seven years of experience as a practicing securities and mergers and acquisitions lawyer. Mr. White earned his B.A. from Amherst College and J.D. from the University of Michigan Law School.

 

Scientific and Clinical Advisory Boards

 

We seek advice from a number of leading scientists and physicians on scientific and medical matters. Our advisory boards regularly assess:

 

    our research and development programs;

 

    our publication strategies;

 

    new technologies relevant to our research and development programs; and

 

    specific scientific and technical issues relevant to our business.

 

The current members of our scientific advisory board are:

 

Name


  

Position


   Affiliation

Paul S. Anderson, Ph.D.

   Former Vice President, Drug Discovery    Bristol-Myers Squibb
Pharmaceuticals

Gordon L. Archer, M.D.

   Associate Dean of Research, School of Medicine    Virginia Commonwealth
University Medical College

Jerome Birnbaum, Ph.D.

   Co-founder and Senior Scientific Advisor    Achillion Pharmaceuticals

 

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Name


  

Position


   Affiliation

Yung-Chi (Tommy) Cheng, Ph.D.

  

Henry Bronson Professor of Pharmacology and Professor of Medicine

Director, Developmental Therapeutics Program

   Yale University School of
Medicine

 

Yale Comprehensive Cancer
Center

Andrew D. Hamilton, Ph.D.

   Provost, Benjamin Silliman Professor of Chemistry and Professor of Molecular Biophysics and Biochemistry    Yale University

Michael Lai, M.D., Ph.D.

   Distinguished Professor Molecular Microbiology and Immunology, Neurology    University of Southern California
School of Medicine

Richard Whitley, M.D.

  

Professor of Pediatrics, Microbiology, Medicine and Neurosurgery

Loeb Eminent Scholar Chair in Pediatrics

   University of Alabama at
Birmingham

 

The current members of our clinical advisory board are:

 

Name


  

Position


   Affiliation

Gordon L. Archer, M.D.

   Associate Dean of Research, School of Medicine    Virginia Commonwealth
University Medical Center

Jules L. Dienstag, M.D.

   Carl W. Walter Professor of Medicine and Physician, Gastrointestinal Unit    Harvard Medical School and
Massachusetts General Hospital

David Ho, M.D.

   Director and Chief Executive Officer and Irene Diamond Professor    Aaron Diamond AIDS Research
Center and Rockefeller
University

John W. Mellors, M.D.

  

Professor of Medicine and

Chief, Division of Infectious Diseases

Director, HIV/AIDS Program

   University of Pittsburgh School
of Medicine

University of Pittsburgh Health
System

Douglas D. Richman, M.D.

   Director, Center for AIDS Research, Professor of Pathology and Medicine, Florence Seeley Riford Chair in AIDS Research    University of California, San
Diego School of Medicine

Eugene Schiff, M.D.

  

Leonard Miller Professor of Medicine

Chief, Division of Hepatology

Director, Center for Liver Disease

   University of Miami School of
Medicine

Robert T. (Chip) Schooley, M.D.

   Professor of Medicine and Head Chief, Division of Infectious Diseases    University of California, San
Diego, School of Medicine

 

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Name


  

Position


   Affiliation

Richard Whitley, M.D.

  

Professor of Pediatrics, Microbiology, Medicine and Neurosurgery

Loeb Eminent Scholar Chair in Pediatrics

   University of Alabama at
Birmingham

 

Board of Directors

 

Our board of directors consists of eight members. Upon completion of this offering, the board of directors will be divided into three classes, with each class serving for a staggered three-year term. The board of directors will consist of three class I directors, Dr. Formela, Mr. Scheer and Mr. Garvey; three class II directors, Mr. Grey, Mr. Kishbauch and Dr. Ryser; and two class III directors, Dr. Fisherman and Mr. White. At each annual meeting of stockholders, a class of directors will be elected for a three-year term to succeed the directors of the same class whose terms are then expiring. The terms of the class I directors, class II directors and class III directors expire upon the election and qualification of successor directors at the annual meeting of stockholders held during the calendar years 2007, 2008 and 2009, respectively.

 

Our bylaws provide that any vacancies in our board of directors and newly created directorships may be filled only by our board of directors and that the authorized number of directors may be changed only by our board of 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 total number of directors. These provisions of our bylaws and the classification of the board of directors may have the effect of delaying or preventing changes in the control or management of Achillion.

 

Each executive officer is elected by, and serves at the discretion of, the board of directors. Each of our executive officers and directors, other than non-employee directors, devotes his or her full time to our affairs. Each of our directors currently serves on the board of directors pursuant to a stockholders agreement. The stockholders agreement, including the provisions relating to the nomination and election of directors, will terminate upon the closing of this offering. There are no family relationships among any of our directors or officers.

 

Committees of the Board of Directors

 

Our board currently has three committees: the audit committee, the compensation committee and the nominating and corporate governance committee. The information set forth below assumes the completion of the proposed offering.

 

Audit Committee

 

The members of our audit committee are Mr. Grey, Mr. White and Dr. Ryser. Mr. Grey chairs the audit committee. Our audit committee, among other duties:

 

    appoints a firm to serve as independent auditor to audit our financial statements;

 

    is responsible for reviewing the independence, qualifications and quality control procedures of the independent auditors;

 

    discusses the scope and results of the audit with the independent auditor, and reviews with management and the independent accountant our interim and year-end operating results;

 

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    considers the adequacy of our internal accounting controls, critical accounting policies and audit procedures; and

 

    approves (or, as permitted, pre-approves) all audit and non-audit services to be performed by the independent auditor.

 

The audit committee has the sole and direct responsibility for appointing, evaluating and retaining our independent auditors and for overseeing their work. All audit services and all non-audit services, other than de minimis non-audit services, to be provided to us by our independent auditors must be approved in advance by our audit committee. We believe that the composition of our audit committee meets the requirements for independence under the current NASDAQ Global Market and SEC rules and regulations.

 

Compensation Committee

 

The members of our compensation committee are Mr. Garvey, Dr. Ryser and Dr. Formela. Mr. Garvey chairs the compensation committee. The purpose of our compensation committee is to discharge the responsibilities of our board of directors relating to compensation of our executive officers. Specific responsibilities of our compensation committee include:

 

    reviewing and recommending approval of compensation of our executive officers;

 

    administering our stock incentive plans; and

 

    reviewing and making recommendations to our board with respect to incentive compensation and equity plans.

 

Nominating and Corporate Governance Committee

 

The members of our nominating and corporate governance committee are Dr. Fisherman, Mr. Scheer and Mr. Garvey. Mr. Scheer chairs the nominating and corporate governance committee. Our nominating and corporate governance committee identifies, evaluates and recommends nominees to our board of directors and committees of our board of directors, conducts searches for appropriate directors and evaluates the performance of our board of directors and of individual directors. The nominating and corporate governance committee is also responsible for reviewing developments in corporate governance practices, evaluating the adequacy of our corporate governance practices and reporting and making recommendations to the board concerning corporate governance matters.

 

Director Compensation

 

Our directors are eligible to participate in our 1998 stock option plan, as amended, and will be eligible to participate in our 2006 stock incentive plan upon completion of this offering. None of our directors receives a fee for serving on the board of directors or any committee of the board. We reimburse each member of our board of directors who is not a company employee for reasonable travel and other expenses incurred in connection with attending meetings of the board of directors and its committees.

 

Compensation Committee Interlocks and Insider Participation

 

The current members of our compensation committee of our board of directors are Mr. Garvey, Dr. Ryser and Dr. Formela. No interlocking relationship exists between our board of directors or compensation committee and the board of directors or compensation committee of any other company, nor has any interlocking relationship existed in the past.

 

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Executive Compensation

 

The following table sets forth the compensation earned by the individual who served as our chief executive officer in 2005 and the four other highest paid executive officers whose salary and bonus exceeded $100,000 for services rendered in all capacities to us during the fiscal year ended December 31, 2005. We use the term “named executive officers” to refer to these people later in this prospectus. No other executive officers who would have otherwise been includable in the following table on the basis of salary and bonus earned for the year ended December 31, 2005 have been excluded by reason of their termination of employment or change in executive status during that year.

 

    Annual Compensation

  Long-Term
Compensation
Awards


     

Name and Principal Position


  Salary ($)

  Bonus ($)

 

Other Annual

Compensation ($)


  Securities
Underlying
Options (#)


  All Other
Compensation


 

Michael D. Kishbauch

President and CEO

  $ 320,000   $ 157,120   —     116,997   $ 1,290 (1)

John Pottage, Jr., M.D.

Senior Vice President and Chief Medical Officer

    226,000     58,815   —     16,250     690 (1)

Milind Deshpande, Ph.D.

Senior Vice President and Chief Scientific Officer

    220,000     55,275   —     16,250     450 (1)

Kevin L. Eastwood(2)

Senior Vice President, Business Development

    215,000     51,760   —     16,250     300 (1)

Gautam Shah, Ph.D.

Senior Vice President and Chief Compliance Officer

    200,000     54,800   —     13,125     450 (1)

(1) Consists of premiums paid on group term life insurance.
(2) Mr. Eastwood resigned from Achillion effective May 30, 2006.

 

Option Grants in Last Fiscal Year

 

The following table lists each grant of stock options during fiscal year 2005 to the named executive officers. No stock appreciation rights have been granted to these individuals. The potential realizable value set forth in the last column of the table is calculated based on the term of the option at the time of grant, which is ten years. This value is based on assumed rates of stock price appreciation of 5% and 10% compounded annually from the date of grant until their expiration date, assuming a fair market value equal to an assumed initial public offering price of $15.00, minus the applicable exercise price. These numbers are calculated based on the requirements of the SEC and do not reflect our estimate of future stock price growth. Actual gains, if any, on stock option exercises will depend on the future performance of the common stock on the date on which the options are exercised.

 

    Individual Grants

   

Name


  Number of
Securities
Underlying
Options
Granted


  Percent of
Total
Options
Granted to
Employees
in Fiscal
Year


    Exercise
Price
($/share)(1)


  Expiration
Date


 

Potential Realizable Value at

Assumed Annual Rates of Stock Price
Appreciation for Option
Term


          5%

  10%

Michael D. Kishbauch

  116,997   44 %   $ 4.00   12/20/15   $ 2,390,649   $ 4,083,913

John Pottage, M.D.

  16,250   6       4.00   12/20/15     332,043     567,225

Milind Deshpande, Ph.D.

  16,250   6       4.00   12/20/15     332,043     567,225

Kevin L. Eastwood(2)

  16,250   6       4.00   8/28/06     —       —  

Gautam Shah, Ph.D.

  13,125   5       4.00   12/20/15     268,189     458,143

(1) This exercise price represents the fair market value per share of our common stock on the date of grant as determined by our board of directors.
(2) Mr. Eastwood resigned from Achillion effective May 30, 2006. Mr. Eastwood’s right to exercise options expired on August 28, 2006.

 

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Option Exercises and Fiscal Year-End Values

 

The following table sets forth information for each of the named executive officers regarding the number of shares subject to both exercisable and unexercisable stock options, as well as the value of unexercised in-the-money options, as of December 31, 2005. There was no public trading market for our common stock as of December 31, 2005. Accordingly, the value of the unexercised in-the-money options at fiscal year-end has been calculated by determining the difference between the exercise price per share and the fair market value of our common stock at fiscal year end, as determined by our board of directors. None of the named executive officers exercised options during the fiscal year ended December 31, 2005.

 

    

Number of Securities Underlying

Unexercised Options

at December 31, 2005(#)(1)


  

Value of Unexercised

In-the-Money Options at

December 31, 2005($)


Name


   Exercisable

   Unexercisable

   Exercisable

   Unexercisable

Michael D. Kishbauch

   387,624    —      $ 649,505    —  

John Pottage, M.D.

   46,250    —      $ 72,000    —  

Milind Deshpande, Ph.D.

   60,625    —      $ 106,500    —  

Kevin L. Eastwood (2)

   51,375    —      $ 84,300    —  

Gautam Shah, Ph.D.

   37,500    —      $ 58,500    —  

(1) Each of these options is immediately exercisable on the date of grant for shares of restricted stock, which are subject to vesting over a specified period of time. As of December 31, 2005, these options were vested as to 84,570, 13,125, 23,203, 19,500 and 8,359 shares for Mr. Kishbauch, Dr. Pottage, Dr. Deshpande, Mr. Eastwood and Dr. Shah, respectively.
(2) Mr. Eastwood resigned from Achillion effective May 30, 2006, and his right to exercise options expired on August 28, 2006.

 

Employment Agreements

 

Michael D. Kishbauch

 

In July 2004, we entered into an employment agreement with Michael D. Kishbauch, our President and Chief Executive Officer, for an initial term that expires on December 31, 2006. The agreement is automatically renewable after the initial term for successive one-year periods unless either party provides written notice to the other party at least six months prior to the expiration of the applicable term. Under the agreement, Mr. Kishbauch currently receives an annual base salary of $340,800, subject to adjustment at the discretion of our board of directors. In addition, Mr. Kishbauch is entitled to receive an annual performance bonus of up to 50% of his annual base salary, to be paid at the discretion of the board of directors if he achieves certain performance goals mutually agreed upon between the board and Mr. Kishbauch. Mr. Kishbauch is also entitled to participate in all benefit programs available to our other employees, to the extent his position, salary, age and other qualifications make him eligible to participate. In connection with the execution of the agreement, we paid Mr. Kishbauch a signing bonus of $50,000 and granted him an option to purchase 270,627 shares of our common stock, which vests over four years.

 

Under the agreement, either we or Mr. Kishbauch may terminate the agreement at any time upon at least 15 days’ prior written notice. In addition, Mr. Kishbauch may terminate the agreement (i) if we require him to relocate such that his daily commute exceeds 60 miles or (ii) for good reason within 12 months following a change in control or similar corporate transaction. If Mr. Kishbauch terminates his employment with us for either of the reasons described in (i) or (ii) above, or if we elect to terminate his employment upon 15 days’ notice, we are required to continue to pay Mr. Kishbauch his then-current salary until the earlier of eighteen months following the date of employment termination or the date upon which Mr. Kishbauch commences full-time employment with another company, but in any event for at least 12 months. If Mr. Kishbauch terminates his employment as described in (i) or (ii) above or if we terminate his employment within 12 months following a change in control or similar corporate transaction, all of the stock options granted to Mr. Kishbauch will

 

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immediately vest and become exercisable. In addition, in the event we experience a change of control or similar corporate transaction, 25% of the original number of common shares subject to stock options held by Mr. Kishbauch will vest and become immediately exercisable.

 

John C. Pottage, Jr., M.D.

 

In September 2003, we entered into an amended and restated employment agreement with John C. Pottage, which was further amended in February 2006. The agreement expires on December 31, 2007 and is thereafter automatically renewable for successive one-year periods unless either party provides written notice to the other party at least six months prior to the expiration of the applicable term. Under this agreement, Dr. Pottage currently receives an annual base salary of $248,600, subject to adjustment at the discretion of our board of directors. In addition, Dr. Pottage is entitled to receive an annual performance bonus of up to 25% of his annual base salary, to be paid at the discretion of the board of directors if he achieves certain performance goals. Dr. Pottage is entitled to participate in all benefit programs available to our other employees, to the extent his position, salary, age and other qualifications make him eligible to participate. In connection with the execution of the agreement, we granted Dr. Pottage an option to purchase 15,000 shares of our common stock, which vests over four years.

 

The agreement may be terminated (i) by us for cause, (ii) by Dr. Pottage for good reason within 12 months following a change in control or similar corporate transaction or (iii) at the election of either party upon at least 15 days’ prior written notice. If Dr. Pottage’s employment with us is terminated by Dr. Pottage pursuant to (ii) above or by us pursuant to (iii) above, we are required to continue to pay Dr. Pottage his then-current salary until the earlier of the date that is six months after the date of termination or the date when Dr. Pottage commences full-time employment with another company. If Dr. Pottage terminates his employment as described in (ii) above or if we terminate his employment within 12 months following a change in control or similar corporate transaction, 50% of the original number of stock options granted to Dr. Pottage will immediately vest and become exercisable. In addition, in the event we experience a change of control or similar corporate transaction, 25% of the original number of stock options granted to Dr. Pottage will vest and become immediately exercisable.

 

Milind S. Deshpande, Ph.D.

 

In September 2003, we entered into an amended and restated employment agreement with Milind Deshpande, Ph.D., which was further amended in February 2006. The agreement expires on December 31, 2007 and is thereafter automatically renewable for successive one-year periods unless either party provides written notice to the other party at least six months prior to the expiration of the applicable term. Under this agreement, Dr. Deshpande currently receives an annual base salary of $236,500, subject to adjustment at the discretion of our board of directors. In addition, Dr. Deshpande is entitled to receive an annual performance bonus of up to 25% of his annual base salary, to be paid at the discretion of the board of directors if he achieves certain performance goals. Dr. Deshpande is entitled to participate in all benefit programs available to our other employees, to the extent his position, salary, age and other qualifications make him eligible to participate. In connection with the execution of the agreement, we granted Dr. Deshpande an option to purchase 18,750 shares of our common stock, which vests over four years.

 

The agreement may be terminated (i) by us for cause, (ii) by Dr. Deshpande for good reason within 12 months following a change in control or similar corporate transaction or (iii) at the election of either party upon at least 15 days’ prior written notice. If Dr. Deshpande’s employment with us is terminated by Dr. Deshpande pursuant to (ii) above or by us pursuant to (iii) above, we are required to continue to pay Dr. Deshpande his then-current salary until the earlier of the date that is six months after the date of employment termination or the date when Dr. Deshpande commences full-time employment with another company. If Dr. Deshpande terminates his employment as described in (ii) above or if we terminate his employment within 12 months following a change in control or similar corporate transaction, 50% of the original number of stock options granted to Dr. Deshpande will immediately vest and become exercisable. In addition, in the event we experience a change of control or similar corporate transaction, 25% of the original number of stock options granted to Dr. Deshpande will vest and become immediately exercisable.

 

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Gautam Shah, Ph.D.

 

In May 2004, we entered into an employment agreement with Gautam Shah, Ph.D., which was amended in February 2006. The agreement expires on December 31, 2007 and is thereafter automatically renewable for successive one-year periods unless either party provides written notice to the other party at least six months prior to the expiration of the applicable term. Under this agreement, Dr. Shah currently receives an annual base salary of $215,000, subject to adjustment at the discretion of our board of directors. In addition, Dr. Shah is entitled to receive an annual performance bonus of up to 25% of his annual base salary, to be paid at the discretion of the board of directors if he achieves certain performance goals. Dr. Shah is entitled to participate in all benefit programs available to our other employees, to the extent his position, salary, age and other qualifications make him eligible to participate. In connection with the execution of the agreement, we granted Dr. Shah an option to purchase 18,125 shares of our common stock, which vests over four years.

 

The agreement may be terminated (i) by us for cause, (ii) by Dr. Shah for good reason within 12 months following a change in control or similar corporate transaction or (iii) at the election of either party upon at least 15 days’ prior written notice. If Dr. Shah’s employment with us is terminated by Dr. Shah pursuant to (ii) above or by us pursuant to (iii) above, we are required to continue to pay Dr. Shah his then-current salary until the earlier of the date that is six months after the date of employment termination or the date when Dr. Shah commences full-time employment with another company. If Dr. Shah terminates his employment as described in (ii) above or if we terminate his employment within 12 months following a change in control or similar corporate transaction, 50% of the original number of stock options granted to Dr. Shah will immediately vest and become exercisable. In addition, in the event we experience a change of control or similar corporate transaction, 25% of the original number of stock options granted to Dr. Shah will vest and become immediately exercisable.

 

Employee Benefit Plans

 

1998 Stock Option Plan

 

Our 1998 stock option plan, or 1998 plan, as amended and restated, was adopted by our board of directors in January 2000 and approved by our stockholders in March 2000. A maximum of 1,093,750 shares of common stock are authorized for issuance under the 1998 plan. As of September 15, 2006, there were options to purchase 807,548 shares of common stock outstanding under the 1998 plan at a weighted average exercise price of $2.28 per share, 557,534 shares of common stock have been issued pursuant to the exercise of options granted under this plan and 56,544 shares of common stock are available for future grants under this plan. After the effective date of the 2006 stock incentive plan described below, we will grant no further stock options or other awards under the 1998 plan.

 

The 1998 plan, as amended, provides for the grant of options intended to qualify as incentive stock options under Section 422 of the Internal Revenue Code of 1986, as amended, and nonqualified stock options. Our employees, officers, directors, consultants and advisors are eligible to receive options under the 1998 plan. Under present law, however, incentive stock options may only be granted to our employees. In accordance with the terms of the 1998 plan, our board of directors administers the 1998 plan.

 

Pursuant to the terms of the 1998 plan, in the event of a proposed liquidation or dissolution of Achillion, our board of directors will provide that all unexercised options will become exercisable in full at least 10 business days prior to the liquidation or dissolution and will terminate upon the liquidation or dissolution.

 

In the event of a merger or other reorganization event, all outstanding options shall be assumed, or substituted for, by the acquiror. If the acquiror does not agree to assume, or substitute for, such options, then the board will (i) provide that all unexercised options will become immediately exercisable in full prior to completion of the reorganization event for shares subject to a right of repurchase by us, and will terminate if not exercised prior to such time or (ii) if holders of common stock will receive a cash payment for each share surrendered in such an event, provide for a cash payment to optionees in accordance with the terms of the plan.

 

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Any repurchase rights of Achillion under any option that may be exercised shall inure to the benefit our successor and shall apply to the cash, securities or other property into which the common stock was converted into or exchanged for pursuant to such event.

 

2006 Stock Incentive Plan

 

Our 2006 stock incentive plan, which we refer to as the 2006 plan, was adopted by our board of directors in May 2006, amended by our board of directors in September 2006 and approved by our stockholders in September 2006 and will become effective as of the date of this prospectus. We have reserved for issuance 750,000 shares of common stock under the 2006 plan. In addition, our plan contains an “evergreen” provision, which allows for an annual increase in the number of shares available for issuance under the plan on the first day of each fiscal year during the period beginning on the first day of fiscal year 2007 and ending on the second day of fiscal year 2010. The annual increase in the number of shares shall be equal to the lowest of:

 

    750,000 shares;

 

    a number of shares that, when added to the number of shares already reserved under the plan, equals 5% of our outstanding shares as of such date; or

 

    an amount determined by our board of directors.

 

The 2006 plan will provide for the grant of incentive stock options, nonstatutory stock options, restricted stock, restricted stock units, stock appreciation rights and other stock-based awards. Our officers, employees, consultants, advisors and directors, and those of any subsidiaries, will be eligible to receive awards under the 2006 plan; however, incentive stock options may only be granted to our employees.

 

Our board of directors will administer the 2006 plan, although it may delegate its authority to a committee. Our board, or a committee to which it has delegated its authority, will select the recipients of awards and determine, subject to any limitations in the 2006 plan:

 

    the number of shares of common stock covered by options and the dates upon which those options become exercisable;

 

    the exercise prices of options;

 

    the duration of options;

 

    the methods of payment of the exercise price; and

 

    the number of shares of common stock subject to any restricted stock or other stock-based awards and the terms and conditions of those awards, including the conditions for repurchase, issue price and repurchase price.

 

Upon the occurrence of a reorganization event (as defined in the 2006 plan), or the signing of an agreement with respect to a reorganization event, all outstanding awards will be assumed or equivalent awards substituted by the successor corporation. Notwithstanding the foregoing, if the acquiring or succeeding corporation in a reorganization event does not agree to assume or substitute for outstanding awards, our board of directors will provide that all unexercised awards will become exercisable in full prior to the reorganization event and the awards, if unexercised, will terminate on the date the reorganization event takes place. If under the terms of the reorganization event holders of our common stock receive cash for their shares, our board may instead provide for a cash-out of the value of any outstanding awards less the applicable exercise price.

 

Upon the occurrence of a reorganization event, or the signing of an agreement with respect to a reorganization event, our repurchase and other rights with respect to shares of restricted stock will inure to the benefit of our successor and will apply equally to the cash, securities or other property into which our common stock is then converted.

 

No award may be granted under the 2006 plan after May 2016, but the vesting and effectiveness of awards granted before that date may extend beyond that date.

 

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Our board of directors may amend, modify or terminate any outstanding award, provided that the consent of a holder of an outstanding award is required unless our board of directors determines that the amendment, modification or termination would not materially and adversely affect the holder. Our board of directors may at any time amend, suspend or terminate the 2006 plan, except that, to the extent determined by our board of directors, no amendment requiring stockholder approval under any applicable legal, regulatory or listing requirement will become effective until the requisite stockholder approval is obtained.

 

Employee Stock Purchase Plan

 

Our 2006 employee stock purchase plan, which we refer to as the purchase plan, was adopted by our board of directors in May 2006, amended by our board of directors in September 2006 and approved by our stockholders in September, 2006 and will become effective upon the completion of this offering. We have reserved a total of 250,000 shares of our common stock for issuance to participating employees under the purchase plan.

 

All of our employees, including our directors who are employees and all employees of any of our participating subsidiaries, who have been employed by us for at least six months prior to enrolling in the purchase plan, who are employees on the first day of the purchase plan period, and whose customary employment is for more than 20 hours a week and for more than five months in any calendar year, will be eligible to participate in the purchase plan. Employees who would, immediately after being granted an option to purchase shares under the purchase plan, own 5% or more of the total combined voting power or value of our common stock will not be eligible to participate in the purchase plan.

 

We will make one or more offerings to our employees to purchase stock under the purchase plan. Offerings will begin on each of December 1 and June 1, or the first business day thereafter, provided that our first offering commencement date will begin on the later of December 1, 2006 or first day of trading following the initial public offering. Each offering commencement date will begin a six-month period during which payroll deductions will be made and held for the purchase of the common stock at the end of the purchase plan period.

 

On the first day of a designated payroll deduction period, or offering period, we will grant to each eligible employee who has elected to participate in the purchase plan an option to purchase shares of our common stock. The employee may authorize up to 15% of his or her compensation to be deducted by us during the offering period. On the last day of the offering period, the employee will be deemed to have exercised the option, at the option exercise price, to the extent of accumulated payroll deductions. Under the terms of the purchase plan, the option exercise price shall be determined by our board of directors or a committee appointed by our board of directors to administer the purchase plan, based on the lesser of the closing price of the common stock on the first business day of the plan period or the exercise date, as defined in the plan, or shall be based solely on the closing price of the common stock on the exercise date, provided that the option exercise price shall be at least 85% of the applicable closing price. In the absence of a determination by our board of directors or the committee, the option exercise price will be the 85% of the lesser of the closing price of the common stock on (i) the first business day of the offering period or (ii) the exercise date.

 

An employee who is not a participant on the last day of the offering period will not be entitled to exercise any option, and the employee’s accumulated payroll deductions will be refunded. An employee’s rights under the purchase plan will terminate upon voluntary withdrawal from the purchase plan at any time, or when the employee ceases employment for any reason, except that upon termination of employment because of death, the balance in the employee’s account will be paid to the employee’s beneficiary.

 

401(k) Plan

 

Our employee savings plan is intended to qualify under Section 401 of the Internal Revenue Code. Our employees may elect to reduce their current compensation by up to the statutorily prescribed annual limit and have the amount of such reduction contributed to the 401(k) plan. We may make matching contributions or additional contributions to the 401(k) plan in amounts to be determined annually by our board of directors.

 

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PRINCIPAL STOCKHOLDERS

 

The following table sets forth certain information known to us regarding beneficial ownership of our common stock as of September 15, 2006 and as adjusted to reflect the sale of the shares of common stock in this offering, assuming the exercise of the underwriters’ overallotment option by:

 

    each person known by us to be the beneficial owner of more than 5% of our common stock;

 

    each of our named executive officers;

 

    each of our directors; and

 

    all executive officers and directors as a group.

 

Beneficial ownership is determined in accordance with the rules of the Securities and Exchange Commission and generally includes voting or investment power with respect to securities. Under these rules, beneficial ownership includes any shares as to which the individual or entity has sole or shared voting power or investment power and includes any shares that an individual or entity has the right to acquire beneficial ownership of within 60 days of September 15, 2006 through the exercise of any warrant, stock option or other right. Except as noted by footnote, and subject to community property laws where applicable, the stockholders named in the table below have sole voting and investment power with respect to all shares of common stock shown as beneficially owned by them.

 

Percentage of common stock beneficially owned before the offering is based on 10,330,391 shares of common stock outstanding on September 15, 2006, which assumes the conversion of all outstanding shares of our convertible preferred stock, including shares of convertible preferred stock to be issued upon the closing of this offering in satisfaction of accumulated dividends (assuming for this purpose that the closing of the offering occurs on October 16, 2006), into 9,815,718 shares of common stock. Percentage of common stock beneficially owned after the offering reflects 14,830,391 shares of common stock outstanding after the completion of this offering. Except as set forth below, the address of all stockholders is c/o Achillion Pharmaceuticals, Inc., 300 George Street, New Haven, Connecticut 06511.

 

         

Percentage of Shares

Beneficially
Owned


 

Name and Address of Beneficial Owner


   Number of Shares
Beneficially
Owned


   Before
Offering


    After
Offering


 

5% Stockholders

                 

Atlas Venture Fund V, L.P. and affiliated entities (1)

890 Winter St., Suite 320

Waltham, MA 02451

   2,036,432    19.58 %   13.67 %

Schroder Ventures International Life Sciences Fund II LP1 and affiliated entities (2)

22 Church St.

Hamilton, HM 11

Bermuda

       
1,770,236
       
17.03
 
 
      
11.89
 
 

Funds affiliated with Advent International Corporation (3)

75 State St., 29 th Fl.

Boston, MA 02109

   1,157,600    11.16     7.78  

Gilead Sciences, Inc.

333 Lakeside Dr.

Foster City, CA 94404

   1,112,944    10.77     7.50  

Bear Stearns Health Innoventures, L.P. and affiliated entities (4)

383 Madison Ave., 30 th Fl.

New York, NY 10179

   1,012,972    9.77     6.81  

 

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Percentage of Shares

Beneficially
Owned


 

Name and Address of Beneficial Owner


   Number of Shares
Beneficially
Owned


   Before
Offering


    After
Offering


 

SGC Partners I LLC and affiliated entities (5)

1221 Avenue of the Americas

New York, NY 10020

   934,168    9.03     6.29  

Connecticut Innovations, Incorporated and affiliated entities (6)

999 West St.

Rocky Hill, CT 06067

   613,939    5.19     4.13  

Named Executive Officers and Directors

                 

Michael D. Kishbauch (7)

   387,624    3.62     2.55  

Milind S. Deshpande, Ph.D. (8)

   76,250    *     *  

John C. Pottage, Jr., M.D. (9)

   58,750    *     *  

Gautam Shah, Ph.D. (10)

   37,500    *     *  

Jason Fisherman, M.D. (3)

   1,157,600    11.16     7.78  

Jean-Francois Formela, M.D. (1)

   2,036,432    19.58     13.67  

James Garvey (14)

   1,856,441    17.86     12.46  

Michael Grey (11)

   12,500    *     *  

Stefan Ryser, Ph.D. (4)

   1,012,972    9.77     6.81  

David I. Scheer (12)

   63,328    *     *  

Christopher A. White (13)

   936,403    9.05     6.31  

All current executive officers and directors as a group (12 individuals) (15)

   7,680,925    69.02 %   49.15 %

  * Represents beneficial ownership of less than one percent of our outstanding common stock.
(1) Consists of 25,856 shares held by Atlas Venture Entrepreneurs’ Fund V, L.P., 1,553,490 shares held by Atlas Venture Fund V, L.P. and 385,932 shares held by Atlas Venture Parallel Fund V-A, C.V. Also includes 71,154 shares issuable upon exercise of warrants. Jean-Francois Formela, M.D., a director of Achillion, is a senior partner of Atlas Venture. Dr. Formela disclaims beneficial ownership of such shares except to the extent of his proportionate pecuniary interest therein.
(2) Consists of 20,449 shares held by Schroder Ventures International Life Sciences Fund II Group Co-Investment Scheme, 1,000,325 shares held by Schroder Ventures International Life Sciences Fund II LP1, 426,032 shares held by Schroder Ventures International Life Sciences Fund II LP2, 113,533 shares held by Schroder Ventures International Life Sciences Fund II LP3, 15,429 shares held by Schroder Ventures International Life Sciences Fund II Strategic Partners L.P., 123,207 shares held by SV (Nominees) Limited as nominee of Schroder Ventures Investments Limited and 8,317 shares held by SITCO Nominees Ltd. VC01903. Also includes 62,944 shares issuable upon exercise of warrants. James Garvey, a director of Achillion, is a member of SV Life Sciences Advisers, LLC which serves as investment adviser to the Schroder Ventures Life Sciences Funds. Mr. Garvey disclaims beneficial ownership of such shares except to the extent of his proportionate pecuniary interest therein.
(3) Consists of 1,004,923 shares held by Advent Healthcare and Life Sciences II Limited Partnership, 78,242 shares held by Advent Healthcare and Life Sciences II Beteiligung GmbH & Co. KG, 22,290 shares held by Advent Partners HLS II Limited Partnership and 9,137 shares held by Advent Partners Limited Partnership. Also includes 43,008 shares issuable upon exercise of warrants. Jason Fisherman, a director of Achillion, is managing director of Advent International. Dr. Fisherman disclaims beneficial ownership of such shares except to the extent of his proportionate pecuniary interest therein.
(4)

Consists of 91,827 shares held by Bear Stearns Health Innoventures Employee Fund, L.P., 116,457 shares held by Bear Stearns Health Innoventures Offshore, L.P., 141,561 shares held by Bear Stearns Health Innoventures, L.P., 65,793 shares held by BSHI Members, L.L.C. and 562,530 shares held by BX, L.P.

 

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Also includes 34,804 shares issuable upon exercise of warrants. Stefan Ryser, a director of Achillion, is a managing partner of Bear Stearns Health Innoventures, L.P. Dr. Ryser disclaims beneficial ownership of such shares except to the extent of his proportionate pecuniary interest therein.

(5) Consists of 222,126 shares held by SG Cowen Ventures I, L.P., 698,807 shares held by SGC Partners I 13,235 shares issuable upon exercise of warrants. Christopher White, a director of Achillion, is Chief of Staff and Chief Administrative Officer of Cowen and Company, LLC and is Vice President of Cowen Group, Inc. Mr. White disclaims beneficial ownership of such shares except to the extent of his proportionate pecuniary interest therein.
(6) Consists of 77,918 shares held by Connecticut Emerging Enterprises, L.P. and 484,980 shares held by Connecticut Innovations, Inc. Also includes 51,041 shares issuable upon exercise of warrants.
(7) Consists of stock options to purchase shares of our common stock currently exercisable or exercisable within 60 days after September 15, 2006.
(8) Includes stock options to purchase 60,625 shares of our common stock currently exercisable or exercisable within 60 days after September 15, 2006.
(9) Includes stock options to purchase 46,250 shares of our common stock currently exercisable or exercisable within 60 days after September 15, 2006.
(10) Consists of stock options to purchase shares of our common stock currently exercisable or exercisable within 60 days after September 15, 2006.
(11) Consists of stock options to purchase shares of our common stock currently exercisable or exercisable within 60 days September 15, 2006.
(12) Consists of 63,246 shares held by Scheer Investment Holdings III, LLC. Also includes 82 shares issuable upon exercise of warrants. David Scheer, a director of Achillion, is the managing member of Scheer Investment Holdings III, LLC. As such, he may be deemed to have sole or shared voting and investment power with respect to the shares held by this fund. Mr. Scheer disclaims beneficial ownership of these shares except to the extent of his pecuniary interest therein.
(13) Includes 222,126 shares held by SG Cowen Ventures I, L.P. and 698,807 shares held by SGC Partners I LLC. Also includes 13,235 shares issuable upon exercise of warrants. Christopher White, a director of Achillion, is Chief of Staff and Chief Administrative Officer of Cowen and Company, LLC and is Vice President of Cowen Group, Inc. Mr. White disclaims beneficial ownership of such shares except to the extent of his proportionate pecuniary interest therein.
(14) Consists of 20,449 shares held by Schroder Ventures International Life Sciences Fund II Group Co-Investment Scheme, 1,000,325 shares held by Schroder Ventures International Life Sciences Fund II LP1, 426,032 shares held by Schroder Ventures International Life Sciences Fund II LP2, 113,533 shares held by Schroder Ventures International Life Sciences Fund II LP3, 15,429 shares held by Schroder Ventures International Life Sciences Fund II Strategic Partners L.P., 123,207 shares held by SV (Nominees) Limited as nominee of Schroder Ventures Investments Limited, 8,317 shares held by SITCO Nominees Ltd. VC01903 and 86,205 shares held by International Biotechnology Trust plc, or IBT. Also includes 62,944 shares issuable upon exercise of warrants. James Garvey, a director of Achillion, is a member of SV Life Sciences Advisers, LLC, which serves as investment adviser to the Schroder Ventures Life Sciences Funds. Mr. Garvey disclaims beneficial ownership of the shares held by the Schroder funds and IBT except to the extent of his proportionate pecuniary interest therein.
(15) Includes stock options to purchase 572,624 shares of our common stock currently exercisable or exercisable within 60 days after September 15, 2006 and 225,227 shares issuable upon exercise of warrants.

 

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CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS

 

Since January 1, 2003, we have engaged in the following transactions with our directors, executive officers and holders of more than 5% of our common stock, on an as converted basis, and affiliates of our directors, executive officers and 5% stockholders.

 

Preferred Stock Issuances

 

Issuance of Series C-1 Convertible Preferred Stock

 

On November 24, 2004, we sold an aggregate of 2,300,437 shares of series C-1 convertible preferred stock at a price per share of $2.1735 for an aggregate purchase price of $5,000,000. All shares of our series C-1 convertible preferred stock, including 174,533 shares of series C-1 convertible preferred stock to be issued upon completion of this offering in satisfaction of accumulated dividends on our series C-1 convertible preferred stock (assuming for this purpose that the closing of the offering occurs on October 16, 2006), will be automatically converted into 369,934 shares of our common stock upon completion of this offering. All of the series C-1 convertible preferred shares were sold to Gilead Sciences, Inc., a holder of more than five percent of our voting securities.

 

Issuances of Series C-2 Convertible Preferred Stock

 

In November 2005, March 2006 and May 2006, we sold an aggregate of 23,425,462 shares of series C-2 convertible preferred stock at a price per share of $1.50 for an aggregate purchase price of $35,138,193. All shares of our series C-2 convertible preferred stock, including 1,275,700 shares of series C-2 convertible preferred stock to be issued upon completion of this offering in satisfaction of accumulated dividends on our series C-2 convertible preferred stock (assuming for this purpose that the closing of the offering occurs on October 16, 2006), will be automatically converted into 3,087,614 shares of our common stock upon completion of this offering. Of the 23,425,462 shares of series C-2 convertible preferred stock issued, an aggregate of 18,501,707 shares were sold to the following director and holders of more than five percent of our voting securities:

 

Name


  

Shares of Series C-2

Convertible

Preferred Stock


   Purchase Price

Atlas Venture Fund V, L.P. and affiliated entities (1)

   3,870,578    $ 5,805,867.00

Schroder Ventures International Life Sciences Fund II LP1 and affiliated entities (2)

   3,416,618      5,124,926.50

Funds affiliated with Advent International Corporation (3)

   1,987,159      2,980,738.50

Bear Stearns Health Innoventures, L.P. and affiliated entities (4)

   1,781,965      2,672,947.50

SGC Partners I LLC and affiliated entities

   1,169,079      1,753,618.50

Connecticut Innovations, Incorporated

   531,295      796,942.50

Gilead Sciences, Inc.

   5,728,347      8,592,520.50

Christopher A. White

   16,666      24,999.00
    
  

Total

   18,501,707    $ 27,752,560.00

(1) Consists of 50,927 shares held by Atlas Venture Entrepreneurs’ Fund V, L.P., 3,059,559 shares held by Atlas Venture Fund V, L.P. and 760,092 shares held by Atlas Venture Parallel Fund V-A, C.V.
(2) Consists of 57,569 shares held by Schroder Ventures International Life Sciences Fund II Group Co-Investment Scheme, 2,001,830 shares held by Schroder Ventures International Life Sciences Fund II LP1, 852,569 shares held by Schroder Ventures International Life Sciences Fund II LP2, 227,205 shares held by Schroder Ventures International Life Sciences Fund II LP3, 30,882 shares held by Schroder Ventures International Life Sciences Fund II Strategic Partners L.P. and 246,563 shares held by SV (Nominees) Limited as nominee of Schroder Ventures Investments Limited.
(3) Consists of 1,791,624 shares held by Advent Healthcare and Life Sciences II Limited Partnership, 139,498 shares held by Advent Healthcare and Life Sciences II Beteiligung GmbH & Co. KG, 39,743 shares held by Advent Partners HLS II Limited Partnership and 16,294 shares held by Advent Partners Limited Partnership.

 

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(4) Consists of 167,286 shares held by Bear Stearns Health Innoventures Employee Fund, L.P., 212,154 shares held by Bear Stearns Health Innoventures Offshore, L.P., 257,888 shares held by Bear Stearns Health Innoventures, L.P., 119,860 shares held by BSHI Members, L.L.C. and 1,024,777 shares held by BX, L.P.

 

Bridge Financing

 

Issuance of Convertible Promissory Notes and Warrants

 

In July and October 2004, we sold convertible promissory notes for an aggregate purchase price of $10,410,706. The convertible promissory notes accrued interest at a rate of 8% per annum and had a maturity date of January 1, 2006. In November 2005, the convertible notes, along with accrued but unpaid interest, converted into an aggregate of 7,592,128 shares of series C-2 convertible preferred stock at a conversion price of $1.50 per share. In connection with the issuance of the convertible promissory notes, we issued warrants for the purchase of shares of our common stock. Upon conversion of the convertible promissory notes, these warrants became exercisable for an aggregate of 248,684 shares of common stock at an exercise price of $4.00 per share.

 

The following table summarizes the participation in the bridge financing by holders of more than five percent of our voting securities:

 

Name


   Aggregate
Consideration Paid


   Series C-2
Convertible
Preferred Shares
Issued upon
Conversion of
Notes


   Number of
Shares of
Common Stock
Underlying
Warrants


Atlas Venture Fund V, L.P. and affiliated entities (1)

   $ 2,846,330.00    2,075,725    71,154

Schroder Ventures International Life Sciences Fund II LP1 and affiliated entities (2)

     2,517,998.00    1,836,284    62,944

Funds affiliated with Advent International Corporation (3)

     1,720,479.21    1,254,681    43,008

Bear Stearns Health Innoventures, L.P. and affiliated
entities (4)

     1,392,343.00    1,015,383    34,804

SGC Partners I LLC

     794,186.00    579,170    13,235

Connecticut Innovations, Incorporated

     500,000.00    364,629    8,333
    

  
  

Total

   $ 9,771,336.21    7,125,872    233,478

(1) Consists of 27,311 shares of series C-2 convertible preferred stock and warrants to purchase 935 shares of common stock held by Atlas Venture Entrepreneurs’ Fund V, L.P., 1,640,789 shares of series C-2 convertible preferred stock and warrants to purchase 56,247 shares of common stock held by Atlas Venture Fund V, L.P. and 407,625 shares of series C-2 convertible preferred stock and warrants to purchase 13,972 shares of common stock held by Atlas Venture Parallel Fund V-A, C.V.
(2) Consists of 30,941 shares of series C-2 convertible preferred stock and warrants to purchase 1,060 shares of common stock held by Schroder Ventures International Life Sciences Fund II Group Co-Investment Scheme, 1,075,896 shares of series C-2 convertible preferred stock and warrants to purchase 36,882 shares of common stock held by Schroder Ventures International Life Sciences Fund II LP1, 458,219 shares of series C-2 convertible preferred stock and warrants to purchase 15,707 shares of common stock held by Schroder Ventures International Life Sciences Fund II LP2, 122,113 shares of series C-2 convertible preferred stock and warrants to purchase 4,185 shares of common stock held by Schroder Ventures International Life Sciences Fund II LP3, 16,598 shares of series C-2 convertible preferred stock and warrants to purchase 568 shares of common stock held by Schroder Ventures International Life Sciences Fund II Strategic Partners L.P. and 132,517 shares of series C-2 convertible preferred stock and warrants to purchase 4,542 shares of common stock held by SV (Nominees) Limited as nominee of Schroder Ventures Investments Limited.
(3)

Consists of 1,131,222 shares of series C-2 convertible preferred stock and warrants to purchase 38,778 shares of common stock held by Advent Healthcare and Life Sciences II Limited Partnership, 88,078 shares of series C-2 convertible preferred stock and warrants to purchase 3,018 shares of common stock held by

 

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Advent Healthcare and Life Sciences II Beteiligung GmbH & Co. KG, 25,093 shares of series C-2 convertible preferred stock and warrants to purchase 860 shares of common stock held by Advent Partners HLS II Limited Partnership and 10,288 shares of series C-2 convertible preferred stock and warrants to purchase 352 shares of common stock held by Advent Partners Limited Partnership.

(4) Consists of 95,322 shares of series C-2 convertible preferred stock and warrants to purchase 3,267 shares of common stock held by Bear Stearns Health Innoventures Employee Fund, L.P., 120,887 shares of series C-2 convertible preferred stock and warrants to purchase 4,143 shares of common stock held by Bear Stearns Health Innoventures Offshore, L.P., 146,948 shares of series C-2 convertible preferred stock and warrants to purchase 5,037 shares of common stock held by Bear Stearns Health Innoventures, L.P., 68,297 shares of series C-2 convertible preferred stock and warrants to purchase 2,340 shares of common stock held by BSHI Members, L.L.C. and 583,929 shares of series C-2 convertible preferred stock and warrants to purchase 20,017 shares of common stock held by BX, L.P.

 

Registration Rights

 

The holders of 9,815,718 shares of common stock, which assumes the conversion of all outstanding shares of our convertible preferred stock, including shares of convertible preferred stock to be issued upon the closing of this offering in satisfaction of accumulated dividends (assuming for this purpose that the closing of the offering occurs on October 16, 2006), into shares of common stock upon completion of this offering, and the holders of warrants to purchase 291,392 shares of our common stock have rights to require us to file registration statements under the Securities Act of 1933, as amended, or the Securities Act, or to include their shares in registration statements that we may file in the future for ourselves or other stockholders. These rights are provided under the terms of an investor rights agreement between us and these holders. These holders include the following director and holders of more than five percent of our voting securities and their affiliates:

 

 

Name


   Number of Shares

Atlas Venture Fund V, L.P. and affiliated funds

   2,036,432

Schroder Ventures International Life Sciences Fund II LP1 and affiliated funds

   1,770,236

Funds affiliated with Advent International Corporation

   1,157,600

Bear Stearns Health Innoventures, L.P. and affiliated funds

   1,012,972

SGC Partners I LLC and affiliated funds

   934,168

Connecticut Innovations, Incorporated and affiliated entities

   613,939

Gilead Sciences, Inc.

   1,112,944

Christopher A. White

   2,235
    

Total

   8,640,526

 

The holders of registration rights in connection with this offering have waived their right to participate in this offering.

 

Stock Option Grants

 

We have granted options to purchase shares of our common stock to our executive officers and directors. See “Management—Director Compensation” on page 78 and “Management—Executive Compensation” and “Management—Option Grants in Last Fiscal Year” on page 79.

 

Other Considerations

 

We have adopted a policy providing that all material transactions between us and our officers, directors and other affiliates must be:

 

    approved by a majority of the members of our board of directors and by a majority of the disinterested members of our board of directors; and

 

    on terms no less favorable to us than those that we believe could be obtained from unaffiliated third parties.

 

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DESCRIPTION OF CAPITAL STOCK

 

The following description of our capital stock and provisions of our certificate of incorporation and bylaws are summaries and are qualified by reference to the certificate of incorporation and the bylaws that will become effective upon closing of this offering. Copies of these documents will be filed with the SEC as exhibits to our registration statement, of which this prospectus forms a part. The descriptions of the common stock and preferred stock reflect changes to our capital structure that will occur upon the closing of this offering.

 

Upon the completion of this offering, our authorized capital stock will consist of 100,000,000 shares of common stock, par value $0.001 per share, and 5,000,000 shares of preferred stock, par value $0.01 per share, all of which shares of preferred stock will be undesignated. Our board of directors may establish the rights and preferences of the preferred stock from time to time. As of September 15, 2006, after giving effect to the conversion of all outstanding shares of convertible preferred stock, including shares of convertible preferred stock to be issued in satisfaction of accumulated dividends (assuming for this purpose that the closing of the offering occurs on October 16, 2006) into shares of common stock, there would have been 10,330,391 shares of common stock issued and outstanding. As of September 15, 2006 there were 109 stockholders of record of our capital stock.

 

Common Stock

 

Holders of common stock are entitled to one vote for each share held on all matters submitted to a vote of stockholders and do not have cumulative voting rights. Accordingly, holders of a majority of the shares of common stock entitled to vote in any election of directors may elect all of the directors standing for election. Holders of common stock are entitled to receive proportionately any dividends as may be declared by our board of directors, subject to any preferential dividend rights of outstanding preferred stock. Upon our liquidation, dissolution or winding up, the holders of common stock are entitled to receive proportionately our net assets available after the payment of all debts and other liabilities and subject to the prior rights of any outstanding preferred stock. Holders of common stock have no preemptive, subscription, redemption or conversion rights. Our outstanding shares of common stock are, and the shares offered by us in this offering will be, when issued and paid for, fully paid and nonassessable. The rights, preferences and privileges of holders of common stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of preferred stock that we may designate and issue in the future.

 

Preferred Stock

 

Under the terms of our certificate of incorporation, our board of directors is authorized to issue shares of preferred stock in one or more series without stockholder approval. Our board of directors has the discretion to determine the rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences, of each series of preferred stock.

 

The purpose of authorizing our board of directors to issue preferred stock and determine its rights and preferences is to eliminate delays associated with a stockholder vote on specific issuances. The issuance of preferred stock, while providing flexibility in connection with possible future acquisitions and other corporate purposes, will affect, and may adversely affect, the rights of holders of any preferred stock that may be issued in the future. It is not possible to state the actual effect of the issuance of any shares of preferred stock on the rights of holders of common stock until the board of directors determines the specific rights attached to that preferred stock. The effects of issuing preferred stock could include one or more of the following:

 

    restricting dividends on the common stock;

 

    diluting the voting power of the common stock;

 

    impairing the liquidation rights of the common stock; or

 

    delaying or preventing changes in control or management of Achillion.

 

We have no present plans to issue any shares of preferred stock.

 

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Warrants

 

As of September 15, 2006 there were issued and outstanding:

 

    warrants to purchase an aggregate of 248,684 shares of common stock at a purchase price equal to $4.00 per share;

 

    warrants to purchase an aggregate of 42,708 shares of common stock at a purchase price equal to $12.00 per share;

 

    warrants to purchase an aggregate of 17,956 shares of series C convertible preferred stock at a purchase price equal to $1.81 per share; and

 

    warrants to purchase an aggregate of 333,332 shares of series C-2 convertible preferred stock at a purchase price equal to $1.50 per share.

 

These warrants provide for adjustments in the event of stock dividends, stock splits, reclassifications or other changes in our corporate structure. Certain of the holders of these warrants have registration rights that are outlined below under the heading “Registration Rights.”

 

Options

 

As of September 15, 2006, options to purchase an aggregate of 807,548 shares of common stock at a weighted average exercise of $2.28 per share were outstanding.

 

Registration Rights

 

The holders of 9,815,718 shares of common stock, after giving effect to the conversion of outstanding convertible preferred stock, including shares of convertible preferred stock to be issued in satisfaction of accumulated dividends (assuming for this purpose that the closing of the offering occurs on October 16, 2006), into shares of common stock upon completion of this offering, and the holders of warrants to purchase 291,392 shares of our common stock, have rights to require us to file registration statements under the Securities Act or to include their shares in registration statements that we may file in the future for ourselves or other stockholders. These rights are provided under the terms of an investor rights agreement between us and these holders. The holders of registration rights in connection with this offering have waived their right to participate in this offering.

 

At any time after the earliest of (i) six months following the effective date of this registration statement, (ii) six months after we have become a reporting company under Section 12 of the Securities Act and (iii) November 17, 2008, the holders of at least 20% of the shares carrying registration rights may demand that we use our reasonable best efforts to register all or a portion of their common stock for sale under the Securities Act, so long as either (A) the aggregate offering price of such securities is reasonably anticipated to exceed $5,000,000 or (B) the shares for which registration has been requested constitute at least 30% of the total outstanding shares having registration rights. We are required to use our reasonable best efforts to effect only three of these registrations. If, at any time, we become eligible to file a registration statement on Form S-3, or any successor form, holders of registration rights may make unlimited requests for us to use our best efforts to effect a registration on such forms of their common stock having an aggregate offering price reasonably anticipated to exceed $1,000,000.

 

If we register any of our common stock, either for our own account or for the account of other securityholders, the holders of registration rights are entitled to notice of the registration and to include all or a portion of their common stock in the registration, subject to the right of the underwriters to limit the number of shares included in the offering.

 

Anti-Takeover Provisions of Delaware Law, our Certificate of Incorporation and our Bylaws

 

We are subject to the provisions of Section 203 of the General Corporation Law of Delaware. Subject to certain exceptions, Section 203 prohibits a publicly held Delaware corporation from engaging in a business combination with an interested stockholder for a period of three years after the person became an interested stockholder, unless the interested stockholder attained such status with the approval of our board of directors or the

 

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business combination is approved in a prescribed manner. A business combination includes, among other things, a merger or consolidation involving us and the interested stockholder and the sale of more than 10% of our assets. In general, an interested stockholder is any entity or person beneficially owning 15% or more of our outstanding voting stock and any entity or person affiliated with or controlling or controlled by such entity or person.

 

Our certificate of incorporation and our bylaws divide our board of directors into three classes with staggered three-year terms. In addition, our certificate of incorporation provides that directors may be removed only for cause by the affirmative vote of the holders of 75% of our shares of capital stock entitled to vote. Under our certificate of incorporation, any vacancy on our board of directors, including a vacancy resulting from an enlargement of our board of directors, may only be filled by vote of a majority of our directors then in office. The classification of our board of directors and the limitations on the removal of directors and filling of vacancies could make it more difficult for a third party to acquire, or discourage a third party from acquiring, control of us.

 

Our certificate of incorporation and our bylaws also provide that any action required or permitted to be taken by our stockholders at an annual meeting or special meeting of stockholders may only be taken if it is properly brought before the meeting and may not be taken by written action in lieu of a meeting. Our certificate of incorporation and our bylaws further provide that, except as otherwise required by law, special meetings of the stockholders may only be called by the chairman of the board, chief executive officer or our board of directors. In addition, our bylaws establish an advance notice procedure for stockholder proposals to be brought before an annual meeting of stockholders, including proposed nominations of persons for election to the board of directors. Stockholders at an annual meeting may only consider proposals or nominations specified in the notice of meeting or brought before the meeting by or at the direction of the board of directors or by a stockholder of record on the record date for the meeting, who is entitled to vote at the meeting and who has delivered timely written notice in proper form to our secretary of the stockholder’s intention to bring such business before the meeting. These provisions could have the effect of delaying until the next stockholders’ meeting stockholder actions that are favored by the holders of a majority of our outstanding voting securities. These provisions may also discourage a third party from making a tender offer for our common stock, because even if it acquired a majority of our outstanding voting securities, the third party would be able to take action as a stockholder, such as electing new directors or approving a merger, only at a duly called stockholders’ meeting, and not by written consent.

 

The General Corporation Law of Delaware provides generally that the affirmative vote of a majority of the shares entitled to vote on any matter is required to amend a corporation’s certificate of incorporation or bylaws, unless a corporation’s certificate of incorporation or bylaws, as the case may be, requires a greater percentage. Our certificate of incorporation and bylaws require the affirmative vote of the holders of at least 75% of the shares of our capital stock issued and outstanding and entitled to vote to amend or repeal any of the provisions described in the prior two paragraphs.

 

Limitation of Liability and Indemnification

 

Our certificate of incorporation contains provisions permitted under the General Corporation Law of Delaware relating to the liability of directors. The provisions eliminate a director’s liability for monetary damages for a breach of fiduciary duty, except in circumstances involving wrongful acts, such as the breach of a director’s duty of loyalty or acts or omissions that involve intentional misconduct or a knowing violation of law. Further, our certificate of incorporation contains provisions to indemnify our directors and officers to the fullest extent permitted by the General Corporation Law of Delaware.

 

Transfer Agent and Registrar

 

The transfer agent and registrar for our common stock is Computershare, with offices at 250 Royall Street, Canton, Massachusetts 02021.

 

NASDAQ Global Market

 

We have applied for the quotation of our common stock on the NASDAQ Global Market under the symbol “ACHN.”

 

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SHARES ELIGIBLE FOR FUTURE SALE

 

Prior to this offering, there has been no market for our common stock and we cannot assure you that a significant public market for our common stock will develop or be sustained after this offering. Future sales of substantial amounts of our common stock in the public market, or the possibility of these sales could adversely affect trading prices of our common stock. Furthermore, since only a limited number of shares will be available for sale shortly after this offering because of certain contractual and legal restrictions on resale described below, sales of substantial amounts of our common stock in the public market after the restrictions lapse could also adversely affect the trading price of our common stock and our ability to raise equity capital in the future.

 

Sales of Restricted Shares

 

Upon completion of this offering, we will have outstanding an aggregate of 14,830,391 shares of common stock, after giving effect to the conversion of outstanding convertible preferred stock, including shares of convertible preferred stock to be issued in satisfaction of accumulated dividends (assuming for this purpose that the closing of the offering occurs on October 16, 2006), assuming no exercise of the underwriters’ overallotment option and no exercise of outstanding options or warrants that were outstanding as of September 15, 2006. Of these shares, the shares sold in this offering will be freely tradable without restrictions or further registration under the Securities Act, unless one of our existing affiliates as that term is defined in Rule 144 under the Securities Act purchases such shares, in which case such shares will remain subject to the resale limitations of Rule 144.

 

The remaining 10,330,391 shares of our common stock held by existing stockholders are restricted shares or are restricted by the contractual provisions described below. Restricted shares may be sold in the public market only if registered or if they qualify for an exemption from registration under Rules 144, 144(k) or 701 of the Securities Act, which are summarized below. Of these restricted shares, 931,492 shares will be available for resale in the public market in reliance on Rule 144(k), 662,430 of which shares are restricted by the terms of the lock-up agreements described below. The remaining 9,398,899 shares become eligible for resale in the public market at various dates thereafter, all of which shares are restricted by the terms of the lock-up agreements. The table below sets forth the approximate number of shares eligible for future sale:

 

Days after Date of this Prospectus


  

Approximate Additional

Number of Shares Becoming

Eligible for Future Sale


On effectiveness

  

269,062

90 days

  

325,609

180 days*

  

8,550,395

At various times after 180 days*

  

1,185,325


* 180 days corresponds to the lock-up period described below in “—Lock-up Agreements.” This lock-up period may be extended or shortened under certain circumstances as described in that section. However, Cowen and Company, LLC may in its sole discretion, at any time without prior notice, release all or any portion of the shares from the restrictions in any of these agreements. In considering any request to release shares from a lock-up agreement, Cowen and Company, LLC will consider the facts and circumstances relating to a request at the time of the request.

 

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Under Rule 144 as currently in effect, beginning 90 days after the date of this prospectus, a person who has beneficially owned restricted shares for at least one year and has complied with the requirements described below would be entitled to sell some of its shares within any three-month period. That number of shares cannot exceed the greater of one percent of the number of shares of our common stock then outstanding, which will equal approximately 148,304 shares immediately after this offering, or the average weekly trading volume of our common stock on the NASDAQ Global Market during the four calendar weeks preceding the filing of a notice on Form 144 reporting the sale.

 

Sales under Rule 144 are also restricted by manner of sale provisions, notice requirements and the availability of current public information about our company. Rule 144 also provides that our affiliates who are selling shares of our common stock that are not restricted shares must nonetheless comply with the same restrictions applicable to restricted shares with the exception of the holding period requirement.

 

Under Rule 144(k), a person who is not deemed to have been one of our affiliates at any time during the 90 days preceding a sale and who has beneficially owned the shares proposed to be sold for at least two years is entitled to sell those shares without complying with the manner of sale, public information, volume limitation or notice provisions of Rule 144. Accordingly, unless otherwise restricted or subject to lock-up agreements, these shares may be sold immediately upon the completion of this offering.

 

Options

 

Rule 701 provides that the shares of common stock acquired upon the exercise of currently outstanding options or other rights granted under our equity plans may be resold, to the extent not restricted by the terms of the lock-up agreements, by persons, other than affiliates, beginning 90 days after the date of this prospectus, restricted only by the manner of sale provisions of Rule 144, and by affiliates in accordance with Rule 144, without compliance with its one-year minimum holding period. All outstanding shares available for resale in the public market in reliance on Rule 701 are restricted by the terms of the lock-up agreements.

 

As of September 15, 2006, our board of directors had authorized an aggregate of up to 1,843,750 shares of common stock for issuance under our existing equity plan as well as equity plans that will be effective upon the closing of this offering, excluding 250,000 shares that will be reserved for issuance under our employee stock purchase plan which will become effective upon completion of this offering. As of September 15, 2006, options to purchase a total of 807,548 shares of common stock were outstanding, all of which options are exercisable and all shares issuable upon exercise of these options are restricted by the terms of the lock-up agreements and by our right to repurchase unvested shares upon the termination of an optionee’s business relationship with us. Of these currently exercisable options, upon the closing of this offering shares no longer will be restricted by our right of repurchase and will be eligible for sale in the public market in accordance with Rule 701 under the Securities Act beginning 180 days after the date of this prospectus.

 

We intend to file one or more registration statements on Form S-8 under the Securities Act following this offering to register all shares of our common stock which have been issued or are issuable upon exercise of outstanding stock options or other rights granted under our equity plans. These registration statements are expected to become effective upon filing. Shares covered by these registration statements will thereupon be eligible for sale in the public market, upon the expiration or release from the terms of the lock-up agreements, to the extent applicable, or subject in certain cases to vesting of such shares.

 

Warrants

 

As of September 15, 2006, there were warrants outstanding to purchase a total of 335,739 shares of common stock (on an as-converted to common stock basis) at a weighted average exercise price of $6.08 per share.

 

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Lock-up Agreements

 

Except for sales of common stock to the underwriters in accordance with the terms of the underwriting agreement, we, each of our directors, executive officers and holders of a substantial majority of our outstanding stock and options to acquire our stock have agreed not to sell or otherwise dispose of, directly or indirectly, any shares of our common stock (or any security convertible into or exchangeable or exercisable for common stock) without the prior written consent of Cowen and Company, LLC for a period of 180 days from the date of this prospectus. The lock-up agreements also provide that (i) if we issue an earnings release or material news or a material event relating to us occurs during the last 17 days of the lock-up period, or (ii) prior to the expiration of the lock-up period, we announce that we will release earnings results during the 16-day period beginning on the last day of the lock-up period, the restrictions imposed by the lock-up agreements shall continue to apply until the expiration of the 18-day period beginning on the issuance of the earnings release or the occurrence of the material news or material event. In addition, for a period of 180 days from the date of this prospectus, except as required by law, we have agreed that our board of directors will not consent to any offer for sale, sale or other disposition, or any transaction which is designed or could be expected to result in the disposition by any person, directly or indirectly, of any shares of our common stock without the prior written consent of Cowen and Company, LLC. Cowen and Company, LLC, in its sole discretion, at any time or from time to time and without notice, may release for sale in the public market all or any portion of the shares restricted by the terms of the lock-up agreements.

 

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UNDERWRITING

 

We and the underwriters for the offering named below have entered into an underwriting agreement with respect to the common stock being offered. Subject to the terms and conditions of the underwriting agreement, each underwriter has severally agreed to purchase from us the number of shares of our common stock set forth opposite its name below. Cowen and Company, LLC, CIBC World Markets Corp. and JMP Securities LLC are the representatives of the underwriters.

 

Underwriter


   Number of
Shares


Cowen and Company, LLC

    

CIBC World Markets Corp.  

    

JMP Securities LLC

    
    

Total

   4,500,000
    

 

The underwriting agreement provides that the obligations of the underwriters are conditional and may be terminated at their discretion based on their assessment of the state of the financial markets. The obligations of the underwriters may also be terminated upon the occurrence of the events specified in the underwriting agreement. The underwriters have agreed, severally and not jointly, to purchase all of the shares sold under the underwriting agreement if any of these shares are purchased, other than those shares covered by the overallotment option described below. If an underwriter defaults, the underwriting agreement provides that the purchase commitments of the non-defaulting underwriters may be increased or the underwriting agreement may be terminated.

 

We have agreed to indemnify the underwriters against specified liabilities, including liabilities under the Securities Act, and to contribute to payments the underwriters may be required to make in respect thereof.

 

The underwriters are offering the shares, subject to prior sale, when, as and if issued to and accepted by them, subject to approval of legal matters by their counsel and other conditions specified in the underwriting agreement. The underwriters reserve the right to withdraw, cancel or modify offers to the public and to reject orders in whole or in part.

 

Overallotment Option to Purchase Additional Shares . We have granted to the underwriters an option to purchase up to 675,000 additional shares of common stock at the public offering price, less the underwriting discount. This option is exercisable for a period of 30 days. The underwriters may exercise this option solely for the purpose of covering overallotments, if any, made in connection with the sale of common stock offered hereby. To the extent that the underwriters exercise this option, the underwriters will purchase additional shares from us in approximately the same proportion as shown in the table above.

 

Discounts and Commissions . The following table shows the public offering price, underwriting discount and proceeds, before expenses, to us. These amounts are shown assuming both no exercise and full exercise of the underwriters’ option to purchase additional shares.

 

We estimate that the total expenses of the offering, excluding underwriting discount, will be approximately $1,700,000 and are payable by us.

 

          Total

     Per Share

   Without Over-
Allotment


   With Over-
Allotment


Public offering price

              

Underwriting discount

              

Proceeds, before expenses, to Achillion

              

 

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The underwriters propose to offer the shares of common stock to the public at the public offering price set forth on the cover of this prospectus. The underwriters may offer the shares of common stock to securities dealers at the public offering price less a concession not in excess of $                 per share. The underwriters may allow, and the dealers may reallow, a discount not in excess of $                 per share to other dealers. If all of the shares are not sold at the public offering price, the underwriters may change the offering price and other selling terms.

 

Discretionary Accounts . The underwriters do not intend to confirm sales of the shares to any accounts over which they have discretionary authority.

 

Market Information . Prior to this offering, there has been no public market for shares of our common stock. The initial public offering price will be determined by negotiations between us and the representatives of the underwriters. An active trading market for the shares may not develop. It is also possible that after the offering the shares will not trade in the public market at or above the initial public offering price.

 

We have applied for the listing of our common stock on the NASDAQ Global Market under the symbol “ACHN.”

 

Stabilization . In connection with this offering, the underwriters may engage in stabilizing transactions, overallotment transactions, syndicate covering transactions, penalty bids and purchases to cover positions created by short sales.

 

    Stabilizing transactions permit bids to purchase shares of common stock so long as the stabilizing bids do not exceed a specified maximum, and are engaged in for the purpose of preventing or retarding a decline in the market price of the common stock while the offering is in progress.

 

    Overallotment transactions involve sales by the underwriters of shares of common stock in excess of the number of shares the underwriters are obligated to purchase. This creates a syndicate short position which may be either a covered short position or a naked short position. In a covered short position, the number of shares over-allotted by the underwriters is not greater than the number of shares that they may purchase in the overallotment option. In a naked short position, the number of shares involved is greater than the number of shares in the overallotment option. The underwriters may close out any short position by exercising their overallotment option and/or purchasing shares in the open market.

 

    Syndicate covering transactions involve purchases of 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 with the price at which they may purchase shares through exercise of the overallotment option. If the underwriters sell more shares than could be covered by exercise of the overallotment option and, therefore, have a naked short position, the position can be closed out only by buying shares in the open market. A naked short position is more likely to be created if the underwriters are concerned that after pricing there could be downward pressure on the price of the shares in the open market 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 that syndicate member is purchased in stabilizing or syndicate covering transactions 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 in the open market may be higher than it would otherwise be in the absence of these transactions. Neither we nor the underwriters make any representation

 

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or prediction as to the effect that the transactions described above may have on the price of our common stock. These transactions may be effected on the NASDAQ Global Market, in the over-the-counter market or otherwise and, if commenced, may be discontinued at any time.

 

Passive Market Making. In connection with this offering, underwriters and selling group members may engage in passive market making transactions in our common stock on the NASDAQ Global Market in accordance with Rule 103 of Regulation M under the Securities Exchange Act of 1934, as amended, or the Exchange Act, during a period before the commencement of offers or sales of common stock and extending through the completion of the distribution. A passive market maker must display its bid at a price not in excess of the highest independent bid of that security. However, if all independent bids are lowered below the passive market maker’s bid, that bid must then be lowered when specified purchase limits are exceeded.

 

Lock-Up Agreements . Pursuant to certain “lock-up” agreements, we and our executive officers, directors and certain of our other stockholders, have agreed, subject to certain exceptions, not to offer, sell, contract to sell, announce any intention to sell, pledge or otherwise dispose of, enter into any swap or other agreement that transfers, in whole or in part, the economic consequence of ownership of, directly or indirectly, or file with the SEC a registration statement under the Securities Act relating to, any common stock or securities convertible into or exchangeable or exercisable for any common stock without the prior written consent of Cowen and Company, LLC, for a period of 180 days after the date of the pricing of the offering. The 180-day restricted period will be automatically extended if (i) during the last 17 days of the 180-day restricted period we issue an earnings release or material news or a material event relating to us occurs or (ii) prior to the expiration of the 180-day restricted period, we announce that we will release earnings results or become aware that material news or a material event will occur during the 16-day period beginning on the last day of the 180-day restricted period, in either of which case the restrictions described above will continue to apply until the expiration of the 18-day period beginning on the issuance of the earnings release or the occurrence of the material news or material event.

 

This lock-up provision applies to common stock and to securities convertible into or exchangeable or exercisable for or repayable with common stock. It also applies to common stock owned now or acquired later by the person executing the agreement or for which the person executing the agreement later acquires the power of disposition. The exceptions permit us, among other things and subject to restrictions, to: (a) issue shares pursuant to our existing employee benefit plans, qualified stock option plans or other employee compensation plans or (b) pursuant to currently outstanding options, warrants or rights. The exceptions permit parties to the “lock-up” agreements, among other things and subject to restrictions, to transfer securities: (a) by gift, (b) to a trust for the benefit of the stockholder or an immediate family of the stockholder, (c) by will or intestate succession, (d) to its affiliates, (e) to its wholly-owned subsidiaries or (f) to its partners or members, so long as the transferee agrees to be bound by the terms of the “lock-up” agreement. Cowen and Company, LLC may, in its sole discretion, at any time without prior notice, release all or any portion of the shares from the restrictions in any such agreement. In addition, the lock-up provision will not restrict broker-dealers from engaging in market making and similar activities conducted in the ordinary course of their business.

 

In addition, our securities acquired or held by affiliates of the underwriters will not be sold, transferred, assigned, pledged or hypothecated for a period of 180 days from the effective date of the offering except in accordance with the National Association of Securities Dealers, Inc.’s, or NASD, Rule 2710(g)(2).

 

Electronic Offer, Sale and Distribution of Shares . A prospectus in electronic format may be made available on the websites maintained by one or more of the underwriters or selling group members, if any, participating in this offering and one or more of the underwriters participating in this offering may distribute prospectuses electronically. The representatives may agree to allocate a number of shares to underwriters and selling group members for sale to their online brokerage account holders. Internet distributions will be allocated by the underwriters and selling group members that will make internet distributions on the same basis as other allocations. Other than the prospectus in electronic format, the information on these websites is not part of this prospectus or the registration statement of which this prospectus forms a part, has not been approved or endorsed by us or any underwriter in its capacity as underwriter, and should not be relied upon by investors.

 

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Qualified Independent Underwriter . Under the rules of the NASD, Cowen and Company, LLC may be deemed to be an affiliate of us and/or may be deemed to have a conflict of interest with us. Accordingly, the offering will be made in conformity with certain applicable provisions of NASD Rule 2720. Pursuant to those rules, the initial public offering price can be no higher than that recommended by a qualified independent underwriter, or QIU, which has participated in the preparation of this prospectus and performed its usual standard of due diligence with respect to this prospectus. CIBC World Markets Corp. has agreed to act as a QIU in respect of the offering. The initial public offering price of our common stock will not be higher than the price recommended by CIBC World Markets. CIBC World Markets will not receive any additional compensation for acting in this capacity in connection with the offering. We have agreed to indemnify CIBC World Markets against liabilities incurred in connection with acting as a QIU, including liabilities under the Securities Act.

 

Other Relationship s. The underwriters may, from time to time, engage in transactions with or provide financial advisory services to us in the ordinary course of business. Cowen and Company, LLC received a fee for financial advisory services rendered to us in connection with the third closing of our series C-2 financing in May 2006. Christopher White, a director of Achillion, is Chief of Staff and Chief Administrative Officer of Cowen and Company, LLC and is Vice President of Cowen Group, Inc.

 

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LEGAL MATTERS

 

The validity of the shares of common stock we are offering will be passed upon for us by Wilmer Cutler Pickering Hale and Dorr LLP, Boston, Massachusetts. Legal matters in connection with this offering will be passed upon for the underwriters by Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., Boston, Massachusetts.

 

EXPERTS

 

The financial statements as of December 31, 2005 and December 31, 2004 and for each of the three years in the period ended December 31, 2005 included in this prospectus have been so included in reliance on the report (which contains an explanatory paragraph relating to the removal of an explanatory paragraph relating to our ability to continue as a going concern) of PricewaterhouseCoopers LLP, an independent registered public accounting firm, given on the authority of said firm as experts in auditing and accounting.

 

Fletcher Spaght, Inc. has consented to reference in this prospectus of its report setting forth the appraisal of our securities, and to the use in this prospectus of its name and any statements contained in such report.

 

WHERE YOU CAN FIND MORE INFORMATION

 

We have filed with the Securities and Exchange Commission, or the SEC, a registration statement on Form S-1 under the Securities Act, with respect to our common stock offered hereby. This prospectus, which forms part of the registration statement, does not contain all of the information set forth in the registration statement and the exhibits and schedules to the registration statement. Some items are omitted in accordance with the rules and regulations of the SEC. For further information about us and our common stock, we refer you to the registration statement and the exhibits and schedules to the registration statement filed as part of the registration statement. Statements contained in this prospectus as to the contents of any contract or other document filed as an exhibit are qualified in all respects by reference to the actual text of the exhibit. You may read and copy the registration statement, including the exhibits and schedules to the registration statement, at the SEC’s Public Reference Room at 100 F. Street, N.E., Washington, D.C. 20549. You can obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. In addition, the SEC maintains an Internet site at www.sec.gov, from which you can electronically access the registration statement, including the exhibits and schedules to the registration statement.

 

Upon completion of the offering, we will become subject to the full informational and periodic reporting requirements of the Exchange Act. We will fulfill our obligations with respect to such requirements by filing periodic reports and other information with the SEC. We intend to furnish our stockholders with annual reports containing financial statements certified by an independent registered public accounting firm. We also maintain an Internet site at www.achillion.com. Our internet site is not a part of this prospectus.

 

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Achillion Pharmaceuticals, Inc.

 

INDEX TO FINANCIAL STATEMENTS

 

     Page

Report of Independent Registered Public Accounting Firm

   F-2

Financial Statements:

    

Balance Sheets at December 31, 2004 and 2005 and June 30, 2006 (unaudited)

   F-3

Statements of Operations for the Years Ended December 31, 2003, 2004 and 2005 and the six months ended June 30, 2005 and 2006 (unaudited)

   F-4

Statements of Stockholders’ (Deficit) for the Years Ended December 31, 2003, 2004 and 2005 and the six months ended June 30, 2005 and 2006 (unaudited)

   F-5

Statements of Cash Flows for the Years Ended December 31, 2003, 2004 and 2005 and the six months ended June 30, 2005 and 2006 (unaudited)

   F-6

Notes to Financial Statements

   F-7

 

F-1


Table of Contents

Report of Independent Registered Public Accounting Firm

 

To the Board of Directors and Stockholders of

Achillion Pharmaceuticals, Inc.

 

The reverse stock split described in Note 14 to the financial statements has not been consummated at September 20, 2006. When it has been consummated, we will be in a position to furnish the following report:

 

“In our opinion, the accompanying balance sheets and the related statements of operations, of stockholders’ (deficit) and of cash flows, present fairly, in all material respects, the financial position of Achillion Pharmaceuticals, Inc. at December 31, 2005 and 2004, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2005, in conformity with accounting principles generally accepted in the United States of America. 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 of these statements 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, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

 

Our report dated March 31, 2006 included an explanatory paragraph relating to the Company’s ability to continue as a going concern. As discussed in “Liquidity” in Note 1, the Company has obtained additional financing which has alleviated our substantial doubt about the Company’s ability to continue as a going concern.”

 

/s/ PricewaterhouseCoopers LLP

 

Hartford, Connecticut

March 31, 2006, except for “Liquidity” in Note 1, as to which the date is May 12, 2006 and except for Note 14, as to which the date is  September 18, 2006.

 

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Table of Contents

Achillion Pharmaceuticals, Inc.

Balance Sheets

(in thousands, except per share amounts)

    As of December 31,

   

June 30,

2006


   

Pro Forma
Stockholders’
Equity at
June 30,

2006

(Note 2)


 
    2004

    2005

     
Assets              

(Unaudited)

 

Current assets:

                               

Cash and cash equivalents

  $ 9,481     $ 9,583     $ 20,214          

Marketable securities

    4,897       —         —            

Accounts receivable

    362       761       825          

Prepaid expenses and other current assets

    943       707       2,113          
   


 


 


       

Total current assets

    15,683       11,051       23,152          

Fixed assets, net

    3,153       2,295       1,912          

Deferred financing costs, net

    93       94       70          

Restricted cash

    362       310       310          
   


 


 


       

Total assets

  $ 19,291     $ 13,750     $ 25,444          
   


 


 


       

Liabilities and Stockholders’ (Deficit) Equity

                               

Current liabilities:

                               

Current portion of long-term debt

  $ 988     $ 2,083     $ 3,415          

Accounts payable

    1,560       896       1,061          

Accrued expenses

    1,554       2,216       2,832          

Deferred revenue

    5,317       5,202       2,702          
   


 


 


       

Total current liabilities

    9,419       10,397       10,010          

Long-term debt, net of current portion

    12,080       4,373       6,785          

Accrued expenses, net of current portion

    338       267       265          

Deferred revenue, net of current portion

    2,213             —            

Other long-term liabilities

    180       381       555          
   


 


 


       

Total liabilities

    24,230       15,418       17,615          
   


 


 


       

Commitments (Notes 11 and 12)

                               

Redeemable Convertible Preferred Stock:

                               

Series A Preferred Stock, $.01 par value; 250 shares authorized, issued and outstanding at December 31, 2004 and 2005 and June 30, 2006 (unaudited) and 0 shares issued and outstanding at June 30, 2006 Pro Forma (unaudited) (liquidation preference of $250 at December 31, 2005 and $250 at June 30, 2006 (unaudited))

    250       250       250       —    

Series B Preferred Stock, $.01 par value; 15,817 shares authorized, issued and outstanding at December 31, 2004 and 2005 and June 30, 2006 (unaudited) and 0 shares issued and outstanding at June 30, 2006 Pro Forma (unaudited) (liquidation preference of $27,968 at December 31, 2005 and $28,442 at June 30, 2006 (unaudited))

    26,944       27,893       28,367       —    

Series C Preferred Stock, $.01 par value; 22,436 shares authorized, 22,418 shares issued and outstanding at December 31, 2004 and 2005 and June 30, 2006 (unaudited) and 0 shares issued and outstanding at June 30, 2006 Pro Forma (unaudited) (liquidation preference of $47,258 at December 31, 2005 and $48,069 at June 30, 2006 (unaudited))

    45,505       47,128       47,940       —    

Series C-1 Preferred Stock, $.01 par value; 2,300 shares authorized, issued and outstanding at December 31, 2004 and 2005 and June 30, 2006 (unaudited) and 0 shares issued and outstanding at June 30, 2006 Pro Forma (unaudited) (liquidation preference of $5,217 at December 31, 2005 and $5,316 at June 30, 2006 (unaudited))

    2,041       2,241       2,341       —    

Series C-2 Preferred Stock, $.01 par value; 20,334 and 24,000 shares authorized at December 31, 2005 and June 30, 2006 (unaudited) 11,155 and 23,425 shares issued and outstanding at December 31, 2005 and June 30, 2006 (unaudited), respectively and 0 shares issued and outstanding at June 30, 2006 Pro Forma (unaudited) (liquidation preference of $33,631 at December 31, 2005 and $72,411 at June 30, 2006 (unaudited))

    —         16,842       35,966       —    
   


 


 


 


      74,740       94,354       114,864       —    
   


 


 


 


Stockholders’ (Deficit):

                               

Common stock, $.001 par value; 65,000, 85,000, and 90,000 shares authorized at December 31, 2004, and 2005 and June 30, 2006 (unaudited); 496 and 513 shares issued and outstanding at December 31, 2004 and December 31, 2005 and 515 and 9,683 shares issued and outstanding at June 30, 2006 (unaudited) and June 30, 2006, Pro Forma (unaudited), respectively

    4       4       4       10  

Additional paid-in capital

    —         —         —         114,858  

Stock warrants

    392       341       341       341  

Stock subscription receivable

    (282 )     (181 )     (114 )     (114 )

Retained deficit

    (79,790 )     (96,186 )     (107,270 )     (107,270 )

Unrealized loss on marketable securities

    (3 )     —         4       4  
   


 


 


 


Total stockholders’ (deficit) equity

    (79,679 )     (96,022 )     (107,035 )   $ 7,829  
   


 


 


 


Total liabilities and stockholders’ (deficit) equity

  $ 19,291     $ 13,750     $ 25,444          
   


 


 


       

 

The accompanying notes are an integral part of these financial statements.

 

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Table of Contents

Achillion Pharmaceuticals, Inc.

 

Statements of Operations

(in thousands, except per share amounts)

 

     Years Ended December 31,

    Six Months Ended
June 30,


 
     2003

    2004

    2005

    2005

    2006

 
                       (Unaudited)  

Revenue

   $ —       $ 807     $ 8,526     $ 4,865     $ 4,318  

Operating expenses

                                        

Research and development

     13,194       14,841       18,112       9,415       10,969  

General and administrative

     3,261       3,181       3,101       1,619       2,216  
    


 


 


 


 


Total operating expenses

     16,455       18,022       21,213       11,034       13,185  
    


 


 


 


 


Loss from operations

     (16,455 )     (17,215 )     (12,687 )     (6,169 )     (8,867 )

Other income (expense)

                                        

Interest income

     178       84       224       142       267  

Interest expense

     (348 )     (593 )     (1,200 )     (661 )     (446 )
    


 


 


 


 


Net loss before benefit from state taxes

     (16,625 )     (17,724 )     (13,663 )     (6,688 )     (9,046 )

Tax benefit

     871       264       88       60       50  
    


 


 


 


 


Net loss

     (15,754 )     (17,460 )     (13,575 )     (6,628 )     (8,996 )

Accretion of preferred stock dividends

     (2,572 )     (2,588 )     (2,939 )     (1,386 )     (2,286 )
    


 


 


 


 


Loss attributable to common stockholders

   $ (18,326 )   $ (20,048 )   $ (16,514 )   $ (8,014 )   $ (11,282 )
    


 


 


 


 


Basic and diluted net loss per share attributable to common stockholders (Note 3)

   $ (44.16 )   $ (43.77 )   $ (32.96 )   $ (16.16 )   $ (22.08 )
    


 


 


 


 


Weighted average shares used in computing basic and diluted net loss per share attributable to common stockholders

     415       458       501       496       511  
    


 


 


 


 


Pro forma net loss per share attributable to common stockholders, basic and diluted (unaudited)

                   $ (2.00 )           $ (0.99 )
                    


         


Pro forma weighted average shares used in computing basic and diluted net loss per share attributable to common stockholders (unaudited) (Note 2)

                     6,774               9,127  
                    


         


 

 

 

The accompanying notes are an integral part of these financial statements.

 

F-4


Table of Contents

Achillion Pharmaceuticals, Inc.

 

Statements of Stockholders’ (Deficit) for the Years Ended December 31, 2003, 2004 and 2005 and the Six Months Ended June 30, 2006 (unaudited)

(in thousands)

 

     Common Stock

    Additional
Paid-In
Capital


    Stock
Warrants


    Stock
Subscription
Receivable


    Deferred
Compensation


    Retained
Earnings
(Deficit)


    Unrealized
Gain
(Loss)


    Total
Stockholders’
(Deficit)


 
     Shares

    Amount

               

Balances at January 1, 2003

   569     $ 5     $ —       $ 127     $ (427 )   $ (13 )   $ (41,366 )   $ (8 )   $ (41,682 )

Amortization of stock-based deferred compensation

                                           9                       9  

Stock compensation

                   8                                               8  

Exercise of stock options

   6       —         11                                               11  

Repurchase and settlement of restricted common stock

   (76 )     (1 )     (1 )             109               (107 )     —            

Unrealized gain on marketable securities

                                                           8       8  

Net (loss)

                                                   (15,754 )             (15,754 )

Convertible preferred stock dividends

                   (18 )                             (2,554 )             (2,572 )
    

 


 


 


 


 


 


 


 


Balances at December 31, 2003

   499       4       —         127       (318 )     (4 )     (59,781 )             (59,972 )

Amortization of stock-based deferred compensation

                                           4                       4  

Stock compensation

                   8                                               8  

Warrants issued in connection with debt financing

                           302                                       302  

Exercise of stock options

   1       —         1               36                               37  

Repurchase and settlement of restricted common stock

   (4 )     —         (7 )                                             (7 )

Expiration of warrants

                   37       (37 )                                        

Unrealized (loss) on marketable securities

                                                           (3 )     (3 )

Net (loss)

                                                   (17,460 )             (17,460 )

Convertible preferred stock dividends

                   (39 )                             (2,549 )             (2,588 )
    

 


 


 


 


 


 


 


 


Balances at December 31, 2004

   496       4       —         392       (282 )     —         (79,790 )     (3 )     (79,679 )

Stock compensation

                   70                                               70  

Exercise of stock options

   16       —         26                                               26  

Repayment of stock subscription receivable

   1       —                         101                               101  

Expiration of warrants

                   22       (22 )                                     —    

Reclassification of preferred stock warrants in accordance with FSP 150-5

                           (29 )                                     (29 )

Unrealized gain on marketable securities

                                                           3       3  

Net (loss)

                                                   (13,575 )             (13,575 )

Convertible preferred stock dividends

                   (118 )                             (2,821 )             (2,939 )
    

 


 


 


 


 


 


 


 


Balances at December 31, 2005

   513       4       —         341       (181 )     —         (96,186 )     —         (96,022 )

Stock compensation (unaudited)

                   195                                               195  

Exercise of stock options (unaudited)

   2               3                                               3  

Settlement of stock subscription receivable (unaudited)

                                   67                               67  

Unrealized gain on marketable securities

                                                           4       4  

Net (loss) (unaudited)

                                                   (8,996 )             (8,996 )

Convertible preferred stock dividends (unaudited)

                   (198 )                             (2,088 )             (2,286 )
    

 


 


 


 


 


 


 


 


Balances at June 30, 2006 (unaudited)

   515     $ 4     $ —       $ 341     $ (114 )   $ —       $ (107,270 )   $ 4     $ (107,035 )
    

 


 


 


 


 


 


 


 


 

The accompanying notes are an integral part of these financial statements.

 

F-5


Table of Contents

Achillion Pharmaceuticals, Inc.

 

Statements of Cash Flows

(in thousands)

 

    Years Ended December 31,

   

Six Months

Ended June 30,


 
    2003

    2004

    2005

    2005

    2006

 
                      (Unaudited)  

Cash flows from operating activities

                                       

Net loss

  $ (15,754 )   $ (17,460 )   $ (13,575 )   $ (6,628 )   $ (8,996 )

Adjustments to reconcile net loss to net cash used in operating activities:

                                       

Depreciation and amortization

    1,360       1,288       1,079       521       389  

Noncash stock-based compensation

    17       12       70       40       195  

Noncash interest expense

    18       303       977       546       —    

Loss on disposal of equipment

    11       —         —         —         28  

Amortization of Premium on Securities

    —         —         —         49       4  

Changes in assets and liabilities:

                                       

Accounts receivable

    —         (362 )     (399 )     (2,467 )     (64 )

Prepaid expenses and other current assets

    (337 )     328       236       93       (1,406 )

Account payable

    271       589       (664 )     (272 )     165  

Accrued expenses and other liabilities

    (216 )     926       590       409       788  

Deferred revenue

    —         7,530       (2,328 )     (705 )     (2,500 )
   


 


 


 


 


Net cash (used in) operating activities

    (14,630 )     (6,846 )     (14,014 )     (8,414 )     (11,397 )
   


 


 


 


 


Cash flows from investing activities

                                       

Purchase of property and equipment

    (767 )     (94 )     (98 )     (81 )     (10 )

Proceeds from sale of equipment

    4       —         —         —         —    

Release of restriction on cash

    52       52       52       —         —    

Purchase of marketable securities

    (11,442 )     (4,899 )     —         —         —    

Maturities of marketable securities

    15,972       1,750       4,900       3,600       —    
   


 


 


 


 


Net cash provided by (used in) investing activities

    3,819       (3,191 )     4,854       3,519       (10 )
   


 


 


 


 


Cash flows from financing activities

                                       

Proceeds from issuance of Series C-1 Preferred Stock

    —         2,024       —         —         —    

Proceeds from issuance of Series C-2 Preferred Stock, net of issuance costs

    —         —         5,287       —         18,224  

Proceeds from exercise of stock options

    11       30       26       26       3  

Proceeds from repayment of subscription receivable

    —         —         101       101       67  

Borrowings under notes payable

    594       10,501       5,151       150       5,000  

Repayments of notes payable

    (1,026 )     (1,232 )     (1,178 )     (599 )     (1,256 )

Payment of deferred financing costs

    (3 )     (48 )     (125 )     —         —    
   


 


 


 


 


Net cash provided by (used in) financing activities

    (424 )     11,275       9,262       (322 )     22,038  
   


 


 


 


 


Net (decrease) increase in cash and cash equivalents

    (11,235 )     1,238       102       (5,217 )     10,631  

Cash and cash equivalents, beginning of period

    19,478       8,243       9,481       9,481       9,583  
   


 


 


 


 


Cash and cash equivalents, end of period

  $ 8,243     $ 9,481     $ 9,583     $ 4,264     $ 20,214  
   


 


 


 


 


Supplemental disclosure of cash flow information

                                       

Cash paid for interest

  $ 341     $ 290     $ 179     $ 95     $ 313  

Cash received from tax credits

  $ —       $ 993     $ —         —         —    

Supplemental disclosure of noncash financing activities

                                       

Issuance of warrants in connection with debt financing

  $ —       $ 302     $ 174       —         174  

Conversion of notes payable to Series C-2 Preferred Stock

  $ —       $ —       $ 11,388       —         —    

 

The accompanying notes are an integral part of these financial statements.

 

F-6


Table of Contents

Achillion Pharmaceuticals, Inc.

 

Notes to Financial Statements

(in thousands, except per share amounts)

 

1. Nature of the Business

 

Achillion Pharmaceuticals, Inc. (the “Company”) was incorporated on August 17, 1998 in Delaware. The Company was established to discover, develop and commercialize innovative anti-infective drug therapies.

 

The Company is devoting substantially all of its efforts toward product research and development. During 2005, the Company recognized significant revenues, and therefore is no longer considered a development stage enterprise. The Company has incurred losses since inception of approximately $85,800 through December 31, 2005, and has an accumulated deficit of approximately $96,200 through December 31, 2005. From inception through December 31, 2005, the Company has issued 250, 15,817, 22,418, 2,300 and 11,155 shares of Series A Convertible Preferred Stock (“Series A”), Series B Convertible Preferred Stock (“Series B”), Series C Convertible Preferred Stock (“Series C”), Series C-1 Convertible Preferred Stock (“Series C-1”) and Series C-2 Convertible Preferred Stock (“Series C-2”), respectively, for aggregate net proceeds of $83,200.

 

Liquidity

 

In March 2006 and May 2006, the Company raised $18,406 through the issuance of 12,271 shares of Series C-2, under a second and third closing of the Series C-2. Per share price, rights and preferences were the same as those offered in the November 2005 close (see Note 9). As a result of such issuances, the conversion ratio of Series C and Series C-1 changed from 1.14 to 1.196. Simultaneous with the May 2006 issuance of Series C-2, the Company raised an additional $5,000 through the issuance of promissory notes under its 2005 credit facility (see Note 8). As a result of the issuance of these promissory notes, the Company issued to the lenders warrants to purchase an additional 167 shares of Series C-2 at an exercise price of $1.50 per share. The relative fair value of such warrants at the date of issuance was estimated to be $174 (unaudited), utilizing the Black-Scholes method, using assumptions similar to those outlined in Note 3 below. Such value was recorded as a debt discount which is being amortized as interest expense over the life of the related obligation, and is classified as a liability in the accompanying June 30, 2006 (unaudited) balance sheet (see note 10). Prior to the Company’s May 2006 financings, there was substantial doubt about the Company’s ability to continue as a going concern. After consideration of such financings, management believes this substantial doubt has been alleviated and that the Company has adequate liquidity to fund operations for at least twelve months from the date of the May 2006 financings.

 

The Company expects to incur substantial expenditures in the foreseeable future for the research, development and commercialization of its potential products. The Company will need additional financing to obtain regulatory approvals, fund operating losses, and, if deemed appropriate, establish manufacturing, sales and marketing capabilities, which it will seek to raise through public or private equity or debt financings, collaborative or other arrangements with corporate sources, or through other sources of financing. Adequate additional funding may not be available to the Company on acceptable terms or at all. The Company’s failure to raise capital as and when needed could have a negative impact on its financial condition and its ability to pursue its business strategies. If adequate funds are not available to the Company, the Company may be required to delay, reduce or eliminate research and development programs, reduce or eliminate planned commercialization efforts, obtain funds through arrangements with collaborators or others on terms unfavorable to the Company or pursue merger or acquisition strategies.

 

There can be no assurance that the Company’s research and development will be successfully completed, that adequate patent protection for the Company’s technology will be obtained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. In addition, the Company operates in an environment of rapid change in technology, substantial competition from pharmaceutical and biotechnology companies and is dependent upon the services of its employees and its consultants.

 

F-7


Table of Contents

Achillion Pharmaceuticals, Inc.

 

Notes to Financial Statements—(Continued)

(in thousands, except per share amounts)

 

2. Unaudited Interim Financial Statement and Unaudited Pro Forma Presentation

 

The unaudited pro forma stockholders’ (deficit) as of June 30, 2006 reflects the automatic conversion of all outstanding shares of Series A, Series B, Series C, Series C-1 and Series C-2 as of June 30, 2006. The pro forma net loss per share attributable to common shareholders for the six months ended June 30, 2006 and year ended December 31, 2005 reflect the automatic conversion as of January 1, 2006 or 2005, as applicable, or date of issuance, if later, of all outstanding shares of Series A, Series B, Series C, Series C-1 and Series C-2 into 9,503 and 7,549 shares, respectively, of common stock, which includes 871 and 624 shares, respectively, of common stock issuable for payment in kind dividends to the Series B, Series C, Series C-1 and Series C-2 preferred stockholders (see Note 9).

 

The unaudited condensed financial statements as of June 30, 2006 and for the six months ended June 30, 2005 and 2006 have been prepared in accordance with generally accepted accounting principles for interim financial information on Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management all adjustments, consisting primarily of normal recurring accruals, considered necessary for a fair statement of the results of these interim periods have been included. The results of operations for the six months ended June 30, 2006 are not necessarily indicative of the results that may be expected for the full year.

 

3. Summary of Significant Accounting Policies

 

Use of Estimates

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

 

Revenue Recognition

 

The Company recognizes revenue from contract research and development and research progress payments in accordance with Staff Accounting Bulletin (“SAB”), No. 104, Revenue Recognition (“SAB 104”) and Financial Accounting Standards Board (“FASB”), Emerging Issue Task Force Issue No. 00-21, Accounting for Revenue Arrangements with Multiple Deliverables (“EITF 00-21”). Revenue-generating research and development collaborations are often multiple element arrangements, providing for a license as well as research and development services. Such arrangements are analyzed to determine whether the deliverables, including research and development services, can be separated or whether they must be accounted for as a single unit of accounting in accordance with EITF 00-21. The Company recognizes upfront license payments as revenue upon delivery of the license only if the license has standalone value and the fair value of the undelivered performance obligations can be determined. If the fair value of the undelivered performance obligations can be determined, such obligations would then be accounted for separately as performed. If the license is considered to either (i) not have standalone value or (ii) have standalone value but the fair value of any of the undelivered performance obligations cannot be determined, the arrangement would then be accounted for as a single unit of accounting and the upfront license payments are recognized as revenue over the estimated period of when the Company’s performance obligations are performed.

 

When the Company determines that an arrangement should be accounted for as a single unit of accounting, it must determine the period over which the performance obligations will be performed and revenue related to

 

F-8


Table of Contents

Achillion Pharmaceuticals, Inc.

 

Notes to Financial Statements—(Continued)

(in thousands, except per share amounts)

 

upfront license payments will be recognized. Revenue will be recognized using either a proportionate performance or straight-line method. The Company recognizes revenue using the proportionate performance method provided that it can reasonably estimate the level of effort required to complete its performance obligations under an arrangement and such performance obligations are provided on a best-efforts basis. Direct labor hours or full-time equivalents are typically used as the measure of performance. Under the proportionate performance method, periodic revenue related to upfront license payments is recognized as the percentage of actual effort expended in that period to total effort budgeted for all of the Company’s performance obligations under the arrangement. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the Company expects to complete the related performance obligations. Estimates may change in the future, resulting in a change in the amount of revenue recognized in future periods.

 

Collaborations may also involve substantive milestone payments. 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: (1) the milestone payments are non-refundable, (2) achievement of the milestone involves a degree of risk and was not reasonably assured at the inception of the arrangement, (3) substantive effort is involved in achieving the milestone, (4) the amount of the milestone payment is reasonable in relation to the effort expended or the risk associated with achievement of the milestone and (5) a reasonable amount of time passes between the upfront license payment and the first milestone payment as well as between each subsequent milestone payment (the “Substantive Milestone Method”).

 

Reimbursement of costs is recognized as revenue provided the provisions of EITF Issue No. 99-19 are met, the amounts are determinable and collection of the related receivable is reasonably assured.

 

Research and Development Expenses

 

All costs associated with internal research and development, research and development services for which the Company has externally contracted, and licensed technology are expensed as incurred. Research and development expense includes direct costs for salaries, employee benefits, subcontractors, including clinical research organizations (“CROs”), facility-related expenses and depreciation.

 

Patent Costs

 

The Company expenses the costs of obtaining patents.

 

Stock Compensation

 

Through December 31, 2005, the Company accounted for grants of stock options and restricted stock utilizing the intrinsic value method in accordance with Accounting Principle Board (“APB”) Opinion No. 25, Accounting for Stock Issued to Employees (“APB 25”), and, accordingly, recognized no compensation expense for options when the option grants have an exercise price equal to the fair market value at the date of grant. Under APB 25, compensation expense is computed to the extent that the fair market value of the underlying stock on the date of grant exceeds the exercise price of the employee stock option or stock award. Compensation so computed is then recognized on a straight-line basis over the vesting period. Also through December 31, 2005, the Company had adopted the disclosure-only provisions of Statement of Financial Accounting Standards (“SFAS”) No. 123, Accounting for Stock-Based Compensation (“SFAS No. 123”), as amended by SFAS No. 148, Accounting for Stock Based Compensation—Transition and Disclosure (“SFAS No. 148”).

 

The Company occasionally grants stock option awards to consultants. Such grants are accounted for pursuant to EITF Issue No. 96-18, Accounting for Equity Instruments That Are Issued to Other Than Employees

 

F-9


Table of Contents

Achillion Pharmaceuticals, Inc.

 

Notes to Financial Statements—(Continued)

(in thousands, except per share amounts)

 

for Acquiring, or in Conjunction with Selling, Goods or Services , and, accordingly, recognizes non-cash compensation expense equal to the fair value of such awards and amortizes such expense over the performance period. The unvested equity instruments are revalued on each subsequent reporting date until performance is complete with an adjustment recognized for any changes in their fair value. The Company amortizes expenses related to non-employee stock options in accordance with FIN 28.

 

Had compensation cost for the Company’s stock option plans been determined based on the fair value at the grant dates of awards under these plans consistent with the method prescribed by SFAS 123, the Company’s net loss and pro forma net loss would have been as follows for the years ending December 31, 2003, 2004 and 2005, and for the six months ending June 30, 2005:

 

     Years Ended December 31,

    Six Months
Ended
June 30,
2005


 
     2003

    2004

    2005

    (Unaudited)  
                          

Net loss attributable to common shareholders as reported

   $ (18,326 )   $ (20,048 )   $ (16,514 )   $ (8,014 )

Add: Stock-based employee compensation expense included in net loss

     —         —         57       40  

Less: Total stock-based employee compensation expense determined under fair-value based method for all awards

     (104 )     (213 )     (380 )     (210 )
    


 


 


 


Pro forma net loss attributable to common shareholders

   $ (18,430 )   $ (20,261 )   $ (16,837 )   $ (8,184 )
    


 


 


 


Net loss per share attributable to common shareholders (basic and diluted):

                                

As reported

   $ (44.16 )   $ (43.77 )   $ (32.96 )   $ (16.16 )

Pro forma

   $ (44.41 )   $ (44.24 )   $ (33.61 )   $ (16.50 )

 

The fair value of each employee option grant is estimated on the date of grant using the Black-Scholes option pricing model with the following assumptions for the years ending December 31, 2003, 2004 and 2005:

 

     2003

  2004

  2005

Risk free interest rate

   3.12%   3.60%   4.30%

Expected dividend yield

   0%   0%   0%

Expected lives

   5 years   5 years   5 years

Expected volatility

   100%   70%   70%

 

The effects of applying the provisions of SFAS No. 123 on net loss as stated above is not necessarily representative of the effects on reported income or loss for future years due to, among other things, the number of options granted, the vesting period of the stock options, and the fair value of additional options that may be granted in future years.

 

The Company utilized the historical volatility of peer-group public companies to estimate expected volatility for use in the Black-Scholes option pricing model for all periods shown above.

 

Effective January 1, 2006, the Company began accounting for grants of stock options utilizing the fair value recognition provisions of SFAS No. 123R, Shared-Based Payment (“SFAS No. 123R”) (see Note 10 for more information regarding the adoption of SFAS No. 123R).

 

F-10


Table of Contents

Achillion Pharmaceuticals, Inc.

 

Notes to Financial Statements—(Continued)

(in thousands, except per share amounts)

 

Earnings (Loss) Per Share (“EPS”)

 

Basic EPS is calculated in accordance with SFAS No. 128, Earnings per Share , by dividing net income or loss attributable to common stockholders by the weighted average common stock outstanding. Diluted EPS is calculated in accordance with SFAS No. 128 by adjusting weighted average common shares outstanding for the dilutive effect of common stock options, warrants, convertible preferred stock and accrued but unpaid convertible preferred stock dividends. In periods where a net loss is recorded, no effect is given to potentially dilutive securities, since the effect would be antidilutive. Total securities that could potentially dilute basic EPS in the future that were not included in the computation of diluted EPS because to do so would have been antidilutive as of December 31, 2003, 2004 and 2005, and the six months ended June 30, 2005 and 2006 were as follows:

 

    As of December 31,

  As of
June 30,
2005


  As of
June 30,
2006


    2003

  2004

  2005

   
                (Unaudited)

Options

  259   615   864   608   829

Warrants

  75   319   315   319   336

Convertible Preferred Stock, as converted

  4,810   5,098   6,936   5,098   8,631

Accrued but unpaid Convertible Preferred Stock dividends

  464   591   846   669   1,052
   
 
 
 
 

Total potentially dilutive securities outstanding

  5,608   6,623   8,961   6,694   10,848
   
 
 
 
 

 

Excluded from the weighted average shares are 62, 19, 4 and 1 (unaudited) restricted shares subject to repurchase as of December 31, 2003, 2004 and 2005 and June 30, 2006, respectively.

 

To the extent that the Company’s initial public offering in 2006 (see Note 1) results in additional shares of common stock being issued upon the conversion of some portion of the above securities, those resulting shares of common stock would dilute the Company’s basic and diluted net loss per common share.

 

Segment Information

 

The Company is engaged solely in the discovery and development of innovative anti-infective drug therapies. Accordingly, the Company has determined that it operates in one operating segment.

 

Convertible Preferred Stock

 

The carrying value of convertible preferred stock is increased by periodic accretion to account for accrued but unpaid dividends (see Note 9.) These increases are effected through charges against additional paid-in-capital, if any, and then accumulated deficit.

 

Cash, Cash Equivalents and Restricted Cash

 

Cash and cash equivalents are stated at cost, which approximates market, and include short-term, highly-liquid investments with original maturities of less than three months. The Company also holds certificates of deposit, which collateralize the Company’s facility lease which is classified as restricted cash in the accompanying balance sheets. The restricted cash will be released from restriction at various dates through 2010.

 

Marketable Securities and Equity Investments

 

The Company classifies its marketable securities as “available for sale” and carries these investments at fair value. Unrealized gains or losses on these investments are included as a separate component of

 

F-11


Table of Contents

Achillion Pharmaceuticals, Inc.

 

Notes to Financial Statements—(Continued)

(in thousands, except per share amounts)

 

stockholders’ equity (deficit). The specific identification method was used to determine amortized cost in computing unrealized gain or loss. The Company’s marketable securities as of December 31, 2004, consisted of U.S. Government bonds, corporate bonds and commercial paper. As of December 31, 2004, these securities had a maximum maturity of less than twelve months and carried a weighted average interest rate of approximately 2.67%. The amortized cost of these securities was more than their fair values by $3 as of December 31, 2004. At December 31, 2005 and June 30, 2006 (unaudited), the Company had no marketable securities.

 

All marketable securities held by the Company during the years ending December 31, 2003, 2004 and 2005 were held until maturity, and, as such, the Company did not recognize any realized gains or losses during those years.

 

Fair Value of Financial Instruments

 

The Company’s financial instruments, including cash, cash equivalents, accounts receivable, and accounts payable are carried at cost, which approximates their fair value because of the short-term maturity of these instruments.

 

Concentration of Risk

 

Concentration of credit risk exists with respect to cash and cash equivalents, accounts receivable, and investments. The Company maintains its cash and cash equivalents and investments with high quality financial institutions. At times, amounts may exceed federally insured deposit limits.

 

For the years ended December 31, 2004 and 2005, and the six months ended June 30, 2006, 100%, 97% and 96% (unaudited) of the Company’s revenue was generated from an agreement with one collaboration partner (see Note 4) and at December 31, 2004 and 2005 and June 30, 2006, 100%, 96% and 95% (unaudited) of accounts receivable was due from the same collaboration partner.

 

Fixed Assets

 

Property and equipment are recorded at cost and are depreciated and amortized over the shorter of their lease term or their estimated useful lives on a straight-line basis as follows:

 

Laboratory equipment

   4-7 years

Office equipment

   3-5 years

Leasehold improvements

   8-10 years

 

Expenditures for maintenance and repairs, which do not improve or extend the useful lives of the respective assets, are expensed as incurred. When assets are sold or retired, the related cost and accumulated depreciation are removed from their respective accounts and any resulting gain or loss is included in income (loss).

 

Long-lived Assets

 

SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets, addresses the financial accounting and reporting for impairment or disposal of long-lived assets. The Company reviews the recorded values of long-lived assets for impairment whenever events or changes in business circumstance indicate that the carrying amount of an asset or group of assets may not be fully recoverable.

 

F-12


Table of Contents

Achillion Pharmaceuticals, Inc.

 

Notes to Financial Statements—(Continued)

(in thousands, except per share amounts)

 

Comprehensive Income (Loss)

 

The Company reports and presents comprehensive income (loss) in accordance with SFAS No. 130, Reporting Comprehensive Income , which establishes standards for reporting and display of comprehensive income (loss) and its components in a full set of general purpose financial statements. The objective of the statement is to report a measure of all changes in equity of an enterprise that result from transactions and other economic events of the period other than transactions with owners (comprehensive income (loss)). The Company’s other comprehensive income (loss) arises from net unrealized gains (losses) on marketable securities.

 

Details relating to unrealized gains and losses and other comprehensive loss are as follows (in thousands):

 

     Years Ended December 31,

    Six Months Ended
June 30,


 
     2003

    2004

    2005

    2005

    2006

 
                       (unaudited)  

Net loss

   $ (15,754 )   $ (17,460 )   $ (13,575 )   $ (6,628 )   $ (8,996 )

Unrealized gain (loss) arising during the year

     8       (3 )     3       (2 )     4  
    


 


 


 


 


Total comprehensive loss

   $ (15,746 )   $ (17,463 )   $ (13,572 )   $ (6,630 )   $ (8,992 )
    


 


 


 


 


 

Income Taxes

 

The Company utilizes the asset and liability method of accounting for income taxes, as set forth in SFAS 109, Accounting for Income Taxes (“SFAS 109”). Under this method, deferred tax liabilities and assets are recognized for the expected future tax consequences of temporary differences between the carrying amounts and the tax bases of assets and liabilities. A valuation allowance is established against net deferred tax assets if, based on the weight of available evidence, it is more likely than not that some or all of the net deferred tax assets will not be realized.

 

Recently Issued Accounting Pronouncements

 

In May 2005, the FASB issued SFAS 154, Accounting Changes and Error Corrections , which replaces APB Opinion No. 20, Accounting Changes , and SFAS No. 3, Reporting Accounting Changes in Interim Financial Statements . SFAS 154 changes the requirements for the accounting for and reporting of a change in accounting principle, and applies to all voluntary changes in accounting principle as well as to changes required by new accounting pronouncements, if those pronouncements are silent in regards to specific transition provisions. SFAS 154 requires that retrospective applications be applied to reflect a change in accounting principle to prior periods’ financial statements unless it is impracticable to determine either the period-specific effects or the cumulative effect of the change. SFAS 154 also requires that a change in depreciation, amortization, or depletion method for long-lived, nonfinancial assets be accounted for as a change in accounting estimate affected by a change in accounting principles. SFAS 154 is effective for accounting changes and corrections of errors made in fiscal years beginning after December 15, 2005. The adoption of SFAS No. 154 is not anticipated to be material to the Company’s operating results or financial position.

 

In July 2006, the FASB issued Interpretation No. 48, Accounting for Uncertainty in Income Taxes—an interpretation of FASB Statement No. 109 (“FIN 48”). FIN 48 prescribes a comprehensive model for how a company should recognize, measure, present and disclose in its financial statements uncertain tax positions that

 

F-13


Table of Contents

Achillion Pharmaceuticals, Inc.

 

Notes to Financial Statements—(Continued)

(in thousands, except per share amounts)

 

the company has taken or expects to take on a tax return (including a decision whether to file or not file a return in a particular jurisdiction). Under FIN 48, the financial statements will reflect expected future tax consequences of such positions presuming the taxing authorities’ full knowledge of the position and all relevant facts, but without considering time values. FIN 48 substantially changes the applicable accounting model and is likely to cause greater volatility in income statements as more items are recognized discretely within income tax expense. FIN 48 also revises disclosure requirements and introduces a prescriptive, annual tabular rollforward of the unrecognized tax benefits. FIN 48 is effective for the Company beginning January 1, 2007. The Company is evaluating the impact of adopting FIN 48 on its financial position and results of operations.

 

4. Collaboration Arrangement

 

In November 2004, the Company entered into a collaboration arrangement (the “Gilead Arrangement”) with Gilead Sciences Inc. (“Gilead”) to jointly develop and commercialize compounds for use in treating hepatitis C infection which inhibit viral replication through a specified novel mechanism of action. Commercialization efforts will commence only if such compounds are found to be commercially viable and all appropriate regulatory approvals have been obtained. In connection with this arrangement, Gilead paid to the Company $10,000 as payment for 2,300 newly issued shares of Series C-1 (see Note 9), and for a non-refundable up-front license fee.

 

Under the Gilead Arrangement, the Company and Gilead will work together to develop one or more compounds for use in treating hepatitis C infection until proof-of-concept in one compound, as defined, is achieved (the “Research Period”). Subsequent to the achievement of proof-of-concept, the Company has no further obligation to continue providing services to Gilead but, at Gilead’s request, the Company may elect to extend the Research Period for up to an additional two years after proof-of-concept is established, based upon good faith negotiations at that point in time. Further, if it is agreed that potential back-up compounds should continue to be researched, good faith negotiations would also be conducted to determine the specifics of that arrangement.

 

Gilead has agreed to make milestone payments to the Company upon the achievement of various defined clinical, regulatory and commercial milestones, such as regulatory approval in the United States, the European Union, or Japan, which could total up to $157,500 assuming the successful simultaneous development and commercialization achieving more than $600,000 in worldwide net sales of a lead and back-up compound.

 

The up-front payment of $10,000 was first allocated to the fair value of the Series C-1, as determined by management after considering a valuation analysis performed by an unrelated third-party valuation firm at the direction of the Company, in which each share of the Series C-1 was determined to be worth $0.88 per share, or approximately $2,000 in aggregate. The remaining $8,000 balance of the $10,000 is being accounted for as a non-refundable up-front license fee. Due to certain provisions contained within the Gilead Arrangement relating to services to be performed on both the primary and backup compounds, as defined, the non-refundable up-front license fee, as well as any milestones achieved during the Research Period, will not be accounted for under the substantive milestone method, but rather under the proportionate performance model (see Note 3). Revenue recognized under a proportionate performance model will be limited by the aggregate cash received or receivable to date by the Company. Milestones achieved, if any, after the termination of the Research Period, will be recognized when the milestone is achieved as the Company has no further research or development obligations after the Research Period.

 

Under the Gilead Arrangement, agreed upon research or development expenses, including internal full-time equivalent (“FTE”) costs and external costs, incurred by both companies during the period up to

 

F-14


Table of Contents

Achillion Pharmaceuticals, Inc.

 

Notes to Financial Statements—(Continued)

(in thousands, except per share amounts)

 

proof-of-concept will be borne equally by both parties. The Company is incurring the majority of those expenses and, therefore, is the net receiver of funds under this cost-sharing portion of the arrangement. Payments of $725 and $907 (unaudited) made by the Company to Gilead in 2005 and for the six months ended June 2006 in connection with this collaboration, respectively, have been recognized as a reduction in revenue.

 

Gilead has the right to terminate the agreement without cause upon 120 days written notice to the Company beginning at the earlier of proof-of-concept or November 24, 2006. Upon termination of the agreement for any reason, all cost share amounts due and payable through the date of termination shall be paid by the appropriate party and no previously paid amounts will be refundable.

 

During the years ended December 31, 2004 and 2005 and the six months ended June 30, 2006, the Company recognized revenue of $807, $8,277 and $4,160 (unaudited), respectively, under this collaboration agreement, respectively, of which $446, $4,328 and $2,500 (unaudited), respectively, related to the recognition of the non-refundable fee and first milestone under the proportionate performance model. The remaining $361, $3,949 and $1,660 (unaudited), respectively, recognized during 2004 and 2005 and the six months ended June 30, 2006, respectively, relate to FTE and other external costs billed under the collaboration. The Company, through the Joint Research Committee, is currently in discussions with Gilead regarding whether certain full-time employee or equivalent time billed by Gilead to the collaboration during 2006 is allowed under the Gilead Arrangement. During 2006, the Company reduced its collaboration revenue from Gilead by these billed amounts and recorded only the revenue to date under the collaboration that is fixed and determinable. The Company will recognize additional revenue, if any, in future periods if the Joint Research Committee determines that such amounts billed were not allowed under the Gilead Arrangement. The Company expects that such amounts, if any, would be less than $400. Included in the accompanying 2004 and 2005 and June 30, 2006 balance sheets is $7,530, $5,202 and $ 2,702 (unaudited), respectively, of deferred revenue resulting from the up-front fee and a $2,000 milestone payment received during the Research Period. In addition to Gilead’s rights to unilaterally terminate this agreement, each party has the right to terminate for material breach; however the Company may terminate for Gilead’s breach only on a market-by-market basis, and, if applicable, a product-by-product basis.

 

5. Other Current Assets

 

A summary of other current assets is as follows:

 

     As of December 31,

  

As of

June 30,

2006


         2004    

       2005    

  
               (Unaudited)

Tax credit receivable

   $ 264    $ 352    $ 402

Prepaid expenses

     498      268      1,469

Interest receivable

     129      17      190

Other

     52      70      52
    

  

  

Total

   $ 943    $ 707    $ 2,113
    

  

  

 

F-15


Table of Contents

Achillion Pharmaceuticals, Inc.

 

Notes to Financial Statements—(Continued)

(in thousands, except per share amounts)

 

6. Fixed Assets

 

A summary of property and equipment is as follows:

 

     As of December 31,

   

As of

June 30,

2006


 
     2004

    2005

   
                 (Unaudited)  

Laboratory equipment

   $ 3,866     $ 3,964     $ 3,974  

Office equipment

     745       745       717  

Leasehold improvements

     2,919       2,919       2,919  
    


 


 


       7,530       7,628       7,610  

Less—accumulated depreciation and amortization

     (4,377 )     (5,333 )     (5,698 )
    


 


 


Total

   $ 3,153     $ 2,295     $ 1,912  
    


 


 


 

Depreciation expense was $1,324, $1,260 and $955 for the years ended December 31, 2003, 2004 and 2005, respectively. Depreciation expense was $501 and $390 for the six months ended June 30, 2005 and 2006, respectively (unaudited).

 

7. Accrued Expenses

 

Current and long-term accrued expenses consist of the following:

 

     As of December 31,

  

As of

June 30,

2006


         2004    

       2005    

  
               (Unaudited)

Accrued compensation

   $ 599    $ 632    $ 624

Accrued clinical trial expense

     200      859      973

Accrued preclinical trial expense

     227      364      381

Accrued licenses

     165      180      100

Accrued rent expense

     158      167      165

Accrued manufacturing and formulation

     —        165      175

Accrued IPO costs

     —        —        126

Other accrued expenses

     543      116      553
    

  

  

Total

   $ 1,892    $ 2,483    $ 3,097
    

  

  

 

Accrued clinical trial expenses are comprised of amounts owed to third-party CROs, clinical investigators, laboratories and data managers for research and development work performed on behalf of the Company. At each period end the Company evaluates the accrued clinical trial expense balance based upon information received from each party and ensures that the estimated balance is reasonably stated based upon the information available to the Company. The clinical trial accrual balances represent the Company’s best estimate of amounts owed for clinical trial services based on all information available. Such estimates are subject to change as additional information becomes available.

 

F-16


Table of Contents

Achillion Pharmaceuticals, Inc.

 

Notes to Financial Statements—(Continued)

(in thousands, except per share amounts)

 

8. Long-Term Debt

 

Long-term debt consists of the following:

 

     As of December 31,

   

As of

June 30,
2006


 
         2004    

        2005    

   
                 (Unaudited)  

CII Term Loan, payable in monthly installments of $13 through September 2010 with a final balloon payment of $686, with interest at 7.5% per annum

   $ 1,162     $ 1,091     $ 1,054  

2002 CII Term Loan, payable in monthly installments of $6 through October 2007, with interest at 7.5% per annum

     170       114       85  

2002 Credit Facility, payable in monthly installments as the individual notes mature through January 2007, with interest ranging from 8.01% to 10.17% per annum

     1,036       321       132  

2003 Credit Facility, payable in monthly installments as the individual notes mature through May 2008, with interest ranging from 6.72% to 8.72% per annum

     289       266       165  

2004 Convertible Notes, due January 2006, with interest at 8% per annum

     10,411       —         —    

2005 Credit Facility, payable in monthly installments as notes mature through November 2008, with interest of 10.92% per annum

     —         4,664       8,764  
    


 


 


Total long-term debt

     13,068       6,456       10,200  

Less: current portion

     (988 )     (2,083 )     (3,415 )
    


 


 


Total long-term debt, net of current portion

   $ 12,080     $ 4,373     $ 6,785  
    


 


 


 

During November 2000, the Company entered into a $1,400 term loan (“CII Term Loan”) with Connecticut Innovations, Inc. (CII), a stockholder of the Company. The CII Term Loan is collateralized by personal and real property located at the Company’s facility in New Haven, Connecticut. The current carrying value of the personal and real property located at the Company’s facility that acts as collateral for the loan was $821 as of December 31, 2005. The CII Term Loan contains certain non-financial covenants, including the requirement that the Company maintain its principal place of business and conduct the majority of its operations in Connecticut (“Connecticut Presence”). If the Company fails to maintain its Connecticut Presence, all amounts due under the CII Term Loan shall be immediately due and payable. Maintaining a Connecticut Presence is within management’s control, and the Company currently has no plans to relocate the majority of its operations, and therefore the classification of the CII Term Loan is based on the scheduled payment dates.

 

In 2002, the Company entered into a term loan (“2002 CII Term Loan”) with CII. The 2002 CII Term Loan has other terms that are similar to the CII Term Loan, which includes collateral, non-financial covenants and a requirement that the Company maintain its Connecticut Presence.

 

The CII Term Loan and the 2002 CII Term Loan each contain certain subjective acceleration clauses, which upon the occurrence of a material adverse change in the financial condition, business or operations of the Company in the view of CII (“Material Adverse Change”), may cause amounts due under each of the agreements to become immediately due and payable. Should a Material Adverse Change occur, then the amounts due under each of the 2002 Credit Facility and 2003 Credit Facility could become immediately due and payable. The

 

F-17


Table of Contents

Achillion Pharmaceuticals, Inc.

 

Notes to Financial Statements—(Continued)

(in thousands, except per share amounts)

 

Company has no indication that it is in default of any such clauses and judged acceleration by the lender to be remote based on the Company’s financial circumstances. Based on a waiver received from CII through January 1, 2007, the loans have been classified based on their scheduled payment dates.

 

In July and October 2004, the Company received a total of $10,411 in proceeds from the issuance of convertible notes (“Convertible Notes”). The Convertible Notes accrued interest at a rate of 8% per annum and had a maturity date of January 1, 2006. On November 17, 2005, the Convertible Notes, along with accrued but unpaid interest, were converted in accordance with original terms into 7,592 shares of Series C-2 (see Note 9) at a conversion price of $1.50 per share and accordingly the carrying value of the debt has been reclassified into equity.

 

In connection with the issuance of the Convertible Notes, the Company issued detachable warrants for common stock (see Note 10). A portion of the proceeds received from the issuance of the Convertible Notes was therefore allocated to the warrants, which meet the requirements for equity classification, based on the relative fair value of the two securities. The relative fair value estimated by the Company of these warrants was $302, which was recorded as a debt discount which was amortized into interest expense over the term of the Convertible Notes. The terms of the Convertible Notes also provided that in the event of a sale of the Company prior to the closing of a qualified financing, as defined, the Convertible Notes, at the election of the holders, would either be cancelled and paid out in cash in an amount equal to one and one-half the outstanding principal plus accrued and unpaid interest through the date of such sale, or convert into such number of shares of Series C Convertible Preferred Stock at a conversion price of the Series C Price per share. The Company determined that the fair value of this premium put right was de minimus, both at the time of issuance and through the date of conversion of the Convertible Notes in November 2005. The Company was obligated, however, to continue to evaluate the fair value of the premium put right as such put right was subject to mark to market accounting as a derivative. The Company has also determined that the Convertible Note conversion option did not require bifurcation under the terms and provisions of SFAS 133, “Accounting for Derivative Instruments and Hedging Activities” (SFAS 133), nor was there a beneficial conversion feature resulting from the Convertible Notes from their issue date in 2004 through the date they were exchanged for Series C-2.

 

On December 30, 2005, the Company entered into a credit facility with two lenders (“2005 Credit Facility”). In connection therewith, the Company issued warrants to purchase 167 shares of Series C-2 at an exercise price of $1.50 per share (See Note 10). Substantially all of the Company’s tangible assets are collateral for the 2005 Credit Facility. (See also Note 1—“liquidity”).

 

Future maturities of long-term debt are as follows:

 

Years Ended December 31,

        

2006

   $ 1,967  

2007

     1,960  

2008

     1,859  

2009

     95  

2010

     749  

2011 and thereafter

     —    
    


       6,630  

Less: unamortized debt discount

     (174 )
    


Total

   $ 6,456  
    


 

F-18


Table of Contents

Achillion Pharmaceuticals, Inc.

 

Notes to Financial Statements—(Continued)

(in thousands, except per share amounts)

 

9. Preferred Stock

 

At December 31, 2005, the Company had 76,954 authorized shares of Convertible Preferred Stock, of which 250, 15,817, 22,436, 2,300 and 20,334 were designated as Series A, Series B, Series C, Series C-1 and Series C-2 shares, respectively.

 

During 2004, the Company issued 2,300 shares of Series C-1 Convertible Preferred Stock in connection with the collaboration agreement with Gilead Sciences, Inc. The Company determined, after considering an unrelated third party valuation, that the fair value of these newly issued shares of the Company’s Series C-1 Convertible Preferred Stock was $0.88 per share, or $2,000 in aggregate (see Note 4). The stated terms of the agreement with Gilead provide that accrued dividends, liquidation rights, and conversion rights related to these shares be based upon a $2.17 per share price, as discussed in the significant terms section below.

 

On November 17, 2005, the Company raised $5,289, net of issuance costs, through the issuance of 3,563 shares of Series C-2 Preferred Stock. As part of this issuance, holders of the Convertible Notes converted all outstanding principal and interest, totaling $11,400, into an additional 7,592 shares of Series C-2 Preferred Stock at a conversion price of $1.50 per share (see Note 8). As part of this issuance, the purchasers of the Series C-2 Preferred Stock committed to purchase, subject to the satisfaction of certain representations and warranties, an additional 3,104 shares of Series C-2 at identical terms during a second closing to be held before June 30, 2006 (see Note 1). The Company determined that the fair value of this option to purchase additional shares was de minimus both at the time of issuance and at December 31, 2005. (See also Note 1—“liquidity”).

 

The significant terms of the Series A, Series B, Series C, Series C-1 and Series C-2 are as follows:

 

Voting . The holders of the Series A, Series B, Series C, Series C-1 and Series C-2 are entitled to vote on all matters and shall be entitled to the number of votes equal to the number of shares into which the preferred stock is convertible.

 

Dividends. The Company’s Certificate of Incorporation provides that dividends shall accrue, except with respect to the Series A, whether or not declared and shall be cumulative. When and if declared by the board of directors, such accrued but unpaid dividends shall be payable in cash. Upon an optional conversion at the option of the holder, or a mandatory conversion in connection with a firm commitment underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933 (a “qualified initial public offering”), all such accrued but unpaid dividends on the Series B, Series C, Series C-1 and Series C-2 preferred stock shall be payable in additional shares of Series B, Series C, Series C-1 and Series C-2 preferred stock calculated by dividing the accrued but unpaid dividends by $1.81, $1.81, $2.17 and $1.50, respectively. In a qualified initial public offering, such shares of Series B, Series C, Series C-1 and Series C-2 shall then be automatically converted into shares of common stock as further noted below. Given that conversion of the preferred stock is at the option of the holder at any time, and that upon conversion the holder is entitled to receive cumulative accrued but unpaid dividends, and given that the Company has the option to declare and pay such dividends in cash, the Company’s policy has been to accrue dividends at the stated dividend rates.

 

At such time, if ever, that the Company is obligated to issue additional shares of Series B, Series C, Series C-1 and Series C-2 in connection with an optional or mandatory conversion, the Company will record as an additional dividend the difference, if any, between the fair value of the preferred shares issued in consideration of such accrued but unpaid dividends and the stated dividend rate initially recorded by the Company in its historic financial statements.

 

F-19


Table of Contents

Achillion Pharmaceuticals, Inc.

 

Notes to Financial Statements—(Continued)

(in thousands, except per share amounts)

 

Each share of Series B, Series C and Series C-1 earns cumulative dividends at 4% per annum. Each share of Series C-2 earns cumulative dividends at 8% per annum. No dividends or other distributions shall be made with respect to the Series A or the common stock, until all declared dividends are paid on Series B, Series C, Series C-1 and Series C-2. The accompanying financial statements reflect the following accrued but unpaid dividends which are recorded as additional Preferred Stock:

 

     Years ended December 31,

   Six Months
Ended June 30,


     2003

   2004

   2005

   2005

   2006

                    (unaudited)

Series B

   $ 949    $ 949    $ 949    $ 474    $ 474

Series C

     1,623      1,623      1,623      812      812

Series C-1

     —        16      200      100      100

Series C-2

     —        —        167      —        900
    

  

  

  

  

Total

   $ 2,572    $ 2,588    $ 2,939    $ 1,386    $ 2,286
    

  

  

  

  

 

Liquidation . Series A, Series B, Series C, Series C-1 and Series C-2 stockholders have liquidation preferences equal to $1.00, $1.50, $1.81, $2.17 and $3.00, respectively, plus any accrued but unpaid dividends. Series C-2 is the most senior equity security in regard to liquidation. After the Series C-2, the Series B, Series C, and Series C-1 are on a pari passu basis for liquidation preferences and have preference over Series A and common stockholders. In the event of any dissolution, liquidation or winding up, as defined, which includes a deemed liquidation, any Series C-2 accrued but unpaid dividends shall be paid in such number of shares of Series C-2 as is equal to the accrued but unpaid dividends divided by $1.50. If, upon the completion of required Series C-2 distribution, additional funds remain available, then any Series B, Series C, and Series C-1 accrued but unpaid dividends shall be paid in such number of shares of Series B, Series C, and Series C-1 as is equal to the accrued but unpaid dividends divided by $1.81, $1.81 and $2.17, respectively. These deemed liquidation rights make the Series A, Series B, Series C, Series C-1 and Series C-2 contingently redeemable upon a liquidation or greater than 50% change in control. Due to the uncertain nature of the liquidation rights, no accretion of the preferred stock carrying value to the liquidation preference amount (defined as liquidation value plus cumulative dividends) is recognized within the accompanying financial statements.

 

Conversion . At the option of the holder, the Series A, Series B, Series C, Series C-1 and Series C-2 stockholders can elect to convert their preferred shares into common stock at an initial conversion price of $1.00, $1.50, $1.81, $2.17 and $1.50 per share, respectively, subject to certain anti-dilution adjustments, as defined. Such anti-dilution adjustments, if any, do not result in an obligation to issue a variable number of shares which would require liability classification within the accompanying financial statements. Upon a qualified initial public offering, the preferred stock shall be automatically converted into such number of common shares. As a result of the 2005 Series C-2 financing, the conversion ratios of Series C and Series C-1 changed from 1:1 to 1.14:1 (See also Note 1—“liquidity” and Note 14 “subsequent events”).

 

Preemptive rights . The Series B, C, C-1 and C-2 holders shall have certain pre-emptive rights to purchase new securities sold by the Company.

 

The Company has determined that none of its preferred stock requires liability classification under SFAS 150, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity , as the preferred stock outstanding has no date certain mandatory redemption that is unconditional. In addition, the Company has determined there have been no beneficial conversion features related to any of its outstanding preferred stock from each date of issuance through December 31, 2005.

 

F-20


Table of Contents

Achillion Pharmaceuticals, Inc.

 

Notes to Financial Statements—(Continued)

(in thousands, except per share amounts)

 

10. Common Stock, Stock Options and Warrants

 

Common Stock

 

At December 31, 2005, the Company has 85,000 authorized shares of $0.001 par value common stock.

 

At December 31, 2005, the Company had reserved 7,865 shares of common stock for preferred stock conversion and 1,179 shares for future exercise of outstanding stock options and warrants, or 9,044 shares in aggregate.

 

Stock Options

 

Under the Company’s 1998 Stock Option Plan (“Plan”), incentive and nonqualified stock options may be granted to directors, officers, key employees and consultants of the Company for up to a maximum of 1,094 shares of common stock. Options granted under the Plan are exercisable for a period determined by the Company, but in no event longer than ten years from the date of the grant. Options generally vest ratably over four years. There were 2 shares available under the Plan as of December 31, 2005.

 

The Company’s Plan provides for early exercise, subject to a restriction whereby if the option holder terminates their relationship with the Company prior to the end of the original vesting period, then the Company will repurchase such number of shares that would not yet have been vested under the original terms of the option at a price per share equal to the original option exercise price. At December 31, 2005, of the options exercised pursuant to this agreement, 4 shares were subject to repurchase restrictions. During 2003, 2004 and 2005, 77, 4 and less than 1 of these restricted shares were repurchased by the Company in accordance with the terms of the agreement, respectively. In addition, and in connection with the exercise of certain options prior to December 31, 2002, the Company entered into notes with the option holders for the exercise price of the options, resulting in an aggregate stock subscription receivable of $282 and $181 at December 31, 2004 and 2005, respectively. The notes bear interest at the prevailing interest rate with principal and interest due five years after issuance. The Company has full recourse on all of the accrued but unpaid interest and 20% of the outstanding principal, in addition to the underlying stock collateralizing the notes.

 

A summary of the status of the Company’s stock options, including 67 options granted outside of the Plan, is presented in the table and narrative below:

 

     Options

    Weighted
Average
Exercise
Price


     2003

Outstanding at January 1

   245     $ 1.53

Granted

   113       1.60

Exercised

   (6 )     1.60

Forfeited/Cancelled

   (93 )     1.58
    

 

Outstanding at December 31

   259     $ 1.54
    

 

Options exercisable at December 31

   259     $ 1.54
    

 

Weighted-average fair value of options granted during the year

   —       $ 1.21
          

 

F-21


Table of Contents

Achillion Pharmaceuticals, Inc.

 

Notes to Financial Statements—(Continued)

(in thousands, except per share amounts)

 

     Options

    Weighted
Average
Exercise
Price


     2004

Outstanding at January 1

   259     $ 1.54

Granted

   383       1.60

Exercised

   (1 )     1.60

Forfeited/Cancelled

   (26 )     1.60
    

 

Outstanding at December 31

   615     $ 1.57
    

 

Options exercisable at December 31

   615     $ 1.57
    

 

Weighted-average fair value of options granted during the year

   —       $ 1.44
          

     2005

Outstanding at January 1

   615     $ 1.57

Granted

   268       3.87

Exercised

   (17 )     1.60

Forfeited/Cancelled

   (2 )     1.60
    

 

Outstanding at December 31

   864     $ 2.28
    

 

Options exercisable at December 31

   864     $ 2.28
    

 

Weighted-average fair value of options granted during the year

   —       $ 3.86
          

 

     2006

     (unaudited)

Outstanding at January 1, 2006

   864     $ 2.28

Granted

   1       4.00

Exercised

   (2 )     1.60

Forfeited/Cancelled

   (35 )     2.92
    

 

Outstanding at June 30

   828     $ 2.26
    

 

Options exercisable at June 30

   828     $ 2.26
    

 

Weighted-average fair value of options granted during the period

         $ 2.67
          

 

The following table summarizes information about stock options at December 31, 2005:

 

     Options Outstanding

   Options Vested

Exercises

Prices


   Number
Outstanding


   Weighted Average
Remaining
Contractual Life
(Years)


  

Weighted

Average

Exercise

Price


   Number Vested

  

Weighted

Average

Exercise

Price


$1.20

   41    3.2    $ 1.20    41    $ 1.20

$1.60

   571    8.1      1.60    254      1.60

$4.00

   253    10.0      4.00    —        —  
    
  
  

  
  

     865    8.4    $ 2.28    295    $ 1.54
    
  
  

  
  

 

F-22


Table of Contents

Achillion Pharmaceuticals, Inc.

 

Notes to Financial Statements—(Continued)

(in thousands, except per share amounts)

 

The following table presents weighted average price and life information about significant option groups outstanding at June 30, 2006 (unaudited):

 

     Options Outstanding

   Options Vested

Exercise Prices


   Number
Outstanding


   Weighted
Average
Remaining
Contractual
Life (Years)


   Weighted
Average
Exercise
Price


   Number
Vested


   Weighted
Average
Exercise
Price


$1.20

   41    2.7    $ 1.20    41    $ 1.20

$1.60

   554    7.3      1.60    314      1.60

$4.00

   235    9.5      4.00    —        —  
    
  
  

  
  

     830    7.7    $ 2.26    355    $ 1.55
    
  
  

  
  

 

The Company has historically granted stock options at exercise prices that equaled the fair value of its common stock at the date of grant as estimated by its board of directors. In July 2005, the Company engaged an unrelated valuation specialist, in order to assist in determining the value of the common stock underlying its stock options, as well as to determine the fair value of securities issued to Gilead Sciences as part of our collaboration agreement (see Note 4). The valuation was performed as of the date of the Gilead Sciences collaboration in November 2004. The valuation utilized the AICPA Practice Aid, Valuation of Privately Held Company Equity Securities Issued as Compensation .

 

During 2005, and through June 30, 2006 (unaudited), the Company granted the following options to employees and recognized expense accordingly:

 

Date of Grant


   Number of
Shares
Underlying
Grant


   Exercise
Price


   Market Value as
Determined by
Management
and Board


   Intrinsic
Value of
Grant


   Compensation
Expense to be
Recognized
over 4 Year
Vesting
Period


1/1/05- 3/31/05

   3    $ 1.60    $ 4.00    $ 2.40    $ 7

4/1/05- 6/30/05

   3    $ 1.60    $ 4.00    $ 2.40    $ 7

7/1/05- 9/30/05

   3    $ 1.60    $ 4.00    $ 2.40    $ 6

10/1/05- 12/31/05

   253    $ 4.00    $ 4.00    $ —      $ —  

1/1/06- 6/30/06 (unaudited)

   1    $ 4.00    $ 4.00    $ —      $ —  
    
                       

Total

   263             —             $ 20
    
                       

 

The table above excludes 7 shares granted to a non-employee in March 2005 for which expense was recognized under EITF 96-18 at that date, as there was no vesting period related to this award.

 

During 2004, options for 299 shares were granted with exercise prices equal to the fair value of the Company’s common stock on the date of grant, as determined by the Company’s Board of Directors. Also during 2004, options for 84 shares were granted with an exercise price below the fair value of the Company’s common stock, based upon the results of an unrelated third-party valuation performed in conjunction with the Gilead Agreement (See Note 9). As a result, $57 of compensation expense is included in the 2005 statement of operations related to these grants, as well as other non-employee grants.

 

During 2003, the Company granted options for 49 shares to management with vesting provisions such that 25% of the options immediately vest upon the change of control of the Company. A total of options for 519 shares granted to management after 2003 contain these same change in control provisions.

 

F-23


Table of Contents

Achillion Pharmaceuticals, Inc.

 

Notes to Financial Statements—(Continued)

(in thousands, except per share amounts)

 

The total intrinsic value of options exercised for the years ended December 31, 2005, 2004, and 2003, and for the period ending June 30, 2006 (unaudited), was $65, $0, $0, and $13, respectively.

The Company recorded $57, $0, and $0 as expense for option grants made to employees in 2005, 2004, and 2003, respectively.

 

Stock Options under SFAS No. 123R (unaudited)

 

In December 2004, the FASB issued SFAS No. 123R, which replaced SFAS No. 123 and superseded APB Opinion No. 25. SFAS No. 123R requires all share-based payments to employees, including grants of employee stock options, to be recognized in the financial statements based on their fair values, and was effective beginning in the first quarter of 2006. Effective January 1, 2006, the Company began accounting for grants of stock options and restricted stock to employees utilizing the fair value recognition provisions of SFAS No. 123R.

 

Adoption of SFAS No. 123R was implemented utilizing modified prospective application (“MPA”). Under MPA, the Company applied SFAS No. 123R for new awards granted after December 31, 2005 and for any awards that were granted prior to December 31, 2005 but were still vesting after December 31, 2005. As of June 30, 2006, no liability awards have been granted.

 

The Company also had a choice of two attribution methods for allocating compensation cost under SFAS No. 123R: the “straight-line” method, which allocates expense on a straight-line basis over the requisite service period of the last separately vesting portion of an award, or the “graded vesting attribution method,” which allocates expense on a straight-line basis over the requisite service period for each separately vesting portion of the award as if the award was, in-substance, multiple awards. The Company chose the former method (i.e. straight-line).

 

The Company also chose to continue utilizing the Black-Scholes-Merton (referred to herein as “Black- Scholes”) model as its chosen option-pricing model. Management concluded that this was the most appropriate method with which to value the Company’s share-based payment arrangements, but notes that if any share-based payment instruments should be granted for which the Black-Scholes method does not meet the measurement objective as stated within SFAS No. 123R, management would utilize a more appropriate method for valuing that instrument. However, management does not believe that any instruments granted to date and accounted for under SFAS No. 123R would require a method other than Black-Scholes in order to meet the measurement objective discussed above.

 

Management also revisited its conclusions regarding the assumptions that underlie the valuation of share-based payment awards. In regards to the calculation of expected term, the Company chose to utilize the “simplified” method for “plain vanilla” options as discussed within SAB No. 107. The Company believes that all factors listed within SAB No. 107 as pre-requisites for utilizing the simplified method are true for the Company and its share-based payment arrangements. The Company currently intends to utilize the simplified method through December 31, 2007, at which point it is anticipated that more detailed information about exercise behavior will be more widely available. When valuing share-based payment awards reported via pro forma results for SFAS No. 123 and SFAS No. 148 prior to the adoption of SFAS No. 123R, an estimate of a five-year expected term for all employees as one weighted-average group was utilized, as this represented an estimate at the lower end of the reasonable range of possible expected terms, given the vesting schedule and maximum contractual maturity, in accordance with the guidance for estimates provided in SFAS No. 123.

 

F-24


Table of Contents

Achillion Pharmaceuticals, Inc.

 

Notes to Financial Statements—(Continued)

(in thousands, except per share amounts)

 

For the calculation of expected volatility, because the Company is a private company, and therefore lacks company specific historical and implied volatility information, the Company based its estimate of expected volatility on the historical volatility of similar entities whose share prices are publicly available. The Company intends to continue to consistently apply this process using the same similar entities until a sufficient amount of historical information regarding the volatility of the Company’s own share price becomes available, or unless circumstances change such that the identified entities are no longer similar to the Company. In this latter case, more suitable, similar entities whose share prices are publicly available, would be utilized in the calculation. This conclusion and approach is consistent with the approach utilized by management when valuing share-based payment awards reported via pro forma results for SFAS No. 123 and SFAS No. 148.

 

Under SFAS No. 123R, the Company has separated its employees into two groupings, which can be summarized as 1) management, including the board of directors; and 2) non-management. However, given the Company’s current use of the simplified method, as discussed above, the establishment of these groupings will not effect the expected term utilized by the Company until the Company ceases to employ the simplified method of estimating expected term. All employees were viewed as one grouping by the Company when valuing share-based payment awards reported via pro forma results for SFAS No. 123 and SFAS No. 148 prior to the adoption of SFAS No. 123R.

 

The risk-free rate utilized when valuing share-based payment arrangements is based on the U.S. Treasury yield curve in effect at the time of grant for the expected term of the particular instrument being valued. This is consistent with the approach utilized by management when valuing share-based payment awards reported via pro forma results for SFAS No. 123 and SFAS No. 148.

 

The weighted-average grant-date fair value of options granted during the first quarter of 2006 was $2.64 (unaudited), and no options were granted during the second quarter of 2006.

 

The fair value of each employee option grant in Q1 2006 was estimated on the date of grant using the Black-Scholes option pricing model with the following assumptions, which were determined as described above.

 

    

Q1 2006

(Unaudited)


Risk free interest rate

   4.83%

Expected dividend yield

   0%

Expected lives

   6.11 years

Expected volatility

   70%

 

The Company recorded $166 of expense for option grants made to employees in the six months ended June 30, 2006 (unaudited). The Company recorded no tax benefit related to these options during the first quarter of 2006 since the Company currently maintains a full valuation allowance.

 

As of June 30, 2006, the aggregate intrinsic value of all in-the-money options outstanding is $5,089 (unaudited). As of June 30, 2006, the total weighted average remaining contractual life of the vested options outstanding is 6.3 years (unaudited), and the aggregate intrinsic value related to these vested options is approximately $2,426 (unaudited).

 

As of June 30, 2006, the total compensation cost related to nonvested options not yet recognized in the financial statements is approximately $760 (unaudited) and the weighted average period over which it is expected to be recognized is 1.6 years (unaudited).

 

F-25


Table of Contents

Achillion Pharmaceuticals, Inc.

 

Notes to Financial Statements—(Continued)

(in thousands, except per share amounts)

 

The Company has a policy of issuing new shares to satisfy share option exercises and expects to continue this practice for the foreseeable future.

 

Nonemployee Grants

 

The Company accounts for options granted to consultants, which include scientific advisory board members, using the Black-Scholes method and in accordance with EITF Consensus No. 96-18. Included in the 2003, 2004 and 2005 option grants are 3, 9 and 0 options, respectively, issued to consultants. Total compensation expense recorded in the accompanying statements of operations associated with consultant option grants is $17, $12 and $13 for the years ended December 31, 2003, 2004 and 2005, respectively.

 

Warrants

 

In connection with the Company’s CII Term Loan and capital expenditure line which has since been repaid (see Note 8), the Company issued warrants to purchase 29 and 25 shares, respectively, of common stock at $12.00 and $1.20 per share, respectively, exercisable through November 2010 and 2005, respectively. The relative fair value of the warrants at the date of issuance was estimated to be $49, utilizing the Black-Scholes method. Such value is recognized as additional interest expense. The 200 warrant shares expired unexercised in November 2005.

 

In March 2001, the Company entered into an agreement to lease additional space in its New Haven facility. In connection with this agreement, the Company issued a warrant to CII (see Note 6), as guarantor of the lease, to purchase 14 shares of common stock, exercisable through March 2011, at an exercise price $12.00 per share. The fair value of the warrant at the date of issuance was estimated to be $12, utilizing the Black-Scholes method. Such value is being recognized as additional interest expense.

 

As part of the 2002 Credit Facility executed in March 2002, the Company issued a warrant to the lender to purchase 18 shares of Series C, exercisable for a period of 7 years, at an exercise price of $1.81 per share. The fair value of such warrants at the date of issuance was estimated to be $27, utilizing the Black-Scholes method. Such value is being recognized as additional interest expense.

 

In connection with the issuance of the Convertible Notes in July and October 2004 (see Note 8), the Company issued a detachable warrant to purchase Common Stock. Warrants of 249 shares were exercisable at a price per share to be determined upon the next qualified financing, as defined, and continue to be exercisable after that point through October 2009. A portion of the proceeds received from the issuance of convertible notes and detachable warrants were allocated to the warrants based on the relative fair values of the two securities (see Note 8) using assumptions similar to those outlined in Note 3, and was recognized as additional interest expense over the term of the Convertible Notes. On November 17, 2005, the final number of shares subject to the warrant and their exercise price were determined to be 249 and $4.00, respectively, based on a qualified financing on that date (see Note 9). The Company has determined that the detachable warrants met the requirement for equity classification at the issuance date and through December 31, 2005.

 

As part of the 2005 Credit Facility, the Company issued a warrant to the lenders to purchase 167 shares of Series C-2 Preferred Stock, exercisable for a period of 7 years at an exercise price of $1.50 per share. The relative fair value of such warrants at the date of issuance was estimated to be $174 (unaudited), utilizing the Black-Scholes method, using assumptions similar to those outlined in Note 3. Such value was recorded as a debt discount which is being amortized as interest expense over the life of the related obligation (See Note 1).

 

F-26


Table of Contents

Achillion Pharmaceuticals, Inc.

 

Notes to Financial Statements—(Continued)

(in thousands, except per share amounts)

 

The Company has classified its outstanding Series C and Series C-2 preferred stock warrants as a liability in its December 31, 2005 balance sheet in accordance with FSP 150-5, Issuers Accounting under FASB Statement No. 150 for Freestanding Warrants and Other Similar Instruments on Shares that are Redeemable (FSP 150-5). The cumulative effect of early adoption of FSP 150-5 was not material to the Company’s financial position or operating results. In addition, the impact subsequent to adoption through December 31, 2005 was not material to the Company’s financial position or operating results.

 

11. License and Research and Development Agreements

 

The Company has entered into certain license and collaborative research agreements with third parties relating to the Company’s drug discovery and development initiatives. Under these agreements, the Company has been granted certain worldwide exclusive licenses to use the licensed compounds or technologies. Included in the accompanying 2003, 2004 and 2005 statements of operations is $287, $831 and $311 of research and development expense resulting from these arrangements, respectively. In order to maintain its rights under these agreements, and provided that the Company does not terminate such agreements, the Company may also be required to pay an additional $545 of aggregate minimum payments over the next five years. The Company may also be required to make future payments to these licensors upon achievement of certain product development milestones for anti-viral products utilizing the third party’s intellectual property, as well as pay royalties on future net sales, if any.

 

12. Commitments

 

401(k) Retirement Plan

 

The Company has a 401(k) defined contribution retirement plan covering substantially all full-time employees. The decision to match any employee contributions is at the sole discretion of the Company. The Company did not make any matching contributions in 2003, 2004 or 2005.

 

Operating Leases

 

The Company leases its operating facility located in New Haven, Connecticut. The lease agreement requires monthly lease payments through April 2010. The Company is recording the expense associated with the lease on a straight-line basis over the expected ten-year minimum term of the lease and, as a result, has accrued amounts of $158 and $167 outstanding as long-term accruals at December 31, 2004 and 2005, respectively.

 

The future minimum annual lease payments under these operating leases at December 31, 2005 are as follows:

 

Years Ended December 31,

      

2006

   $ 942

2007

     960

2008

     976

2009

     991

2010

     659

 

Rent expense under operating leases was approximately $934, $934, $1,006, and $495 (unaudited) for the years ended December 31, 2003, 2004, 2005, and the six months ended June 30, 2006, respectively.

 

F-27


Table of Contents

Achillion Pharmaceuticals, Inc.

 

Notes to Financial Statements—(Continued)

(in thousands, except per share amounts)

 

13. Income Taxes

 

The Company uses an asset and liability approach for financial accounting and reporting of income taxes. Deferred tax assets and liabilities are determined based on temporary differences between financial reporting and tax basis assets and liabilities and are measured by applying enacted rates and laws to taxable years in which differences are expected to be recovered or settled. Further, 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.

 

At December 31, 2005, the Company had available federal net operating loss carryforwards of approximately $78,773, which expire commencing in fiscal 2018 through 2025 and $80,234 of state net operating loss carryforwards, which expire commencing in 2020 through 2025. The Company also has federal research and development credit carryovers of approximately $2,346, which expire commencing in fiscal 2016 and approximately $712 of various state tax credit carryovers. Utilization of these losses and credits may be limited by certain Federal statutory provisions. In connection with prior changes in our ownership, there may have been a cumulative change in ownership over a three year period pursuant to Section 382 of the Internal Revenue Code. The Tax Reform Act of 1986, pursuant to Internal Revenue Code Section 382, contains certain provisions that may limit the Company’s ability to utilize net operating loss and tax credit carryforwards in any given year if certain events occur, including cumulative changes in ownership interests in excess of 50% over a three-year period. There can be no assurance that ownership changes in future periods will not significantly limit the Company’s use of its existing net operating loss and tax credit carryforwards. Additional analysis is still required in order to conclude whether or not a Section 382 change has occurred.

 

The State of Connecticut provides companies with the opportunity to exchange certain research and development credit carryforwards for cash in exchange for foregoing the carryforward of the research and development credit. The program provides for such exchange of the research and development credits at a rate of 65% of the annual research and development credit, as defined. As of December 31, 2005, the Company has recorded a benefit of approximately $88 for the estimated proceeds from the exchange of their 2005 research and development credit. As of December 31, 2004, the Company has recorded a benefit of approximately $264 for the estimated proceeds from the exchange of their 2004 research and development credit. During 2003, the Company filed a claim to exchange their 2002 research and development credit and as a result recognized a state income tax benefit of approximately $739. In addition, as of December 31, 2003, the Company has recorded a benefit of approximately $132 for the estimated proceeds from the exchange of their 2003 research and development credit. Accordingly, the Company has recorded the benefit for the 2002 and 2003 exchange of the research and development credits in 2003, and the benefit for the 2004 exchange of the research and development credits in 2004, and the benefit for the 2005 exchange of the research and development credits in 2005.

 

At December 31, 2005, the Company had gross deferred income tax assets of approximately $38,187, which result primarily from net operating loss and tax credit carryforwards. The entire gross deferred tax asset is offset by a valuation allowance. As the Company has not yet achieved profitable operations, management believes the tax benefits as of December 31, 2005 did not satisfy the realization criteria set forth in SFAS 109 and therefore has recorded a valuation allowance for the entire deferred tax asset.

 

F-28


Table of Contents

Achillion Pharmaceuticals, Inc.

 

Notes to Financial Statements—(Continued)

(in thousands, except per share amounts)

 

Future tax benefits (deferred tax liabilities) related to temporary differences on the following:

 

     As of December 31,

 
     2004

    2005

 

Gross deferred tax assets:

                

Net operating losses

   $ 29,574     $ 32,800  

Tax credits (Federal and State)

     2,428       2,619  

Deferred revenue

     —         2,159  

Other

     399       609  
    


 


       32,401       38,187  

Gross deferred tax liability:

                

Depreciation

     (37 )     —    
    


 


       (37 )     —    
    


 


Less—valuation allowance

     (32,364 )     (38,187 )
    


 


Net deferred tax asset

   $ —       $ —    
    


 


 

The Company’s effective income tax rate differed from the Federal Statutory rate due to deferred state taxes and the Company’s full valuation allowance, the latter of which reduced the Company’s effective income tax rate to zero.

 

The income tax provision (benefit) consists of the following:

 

     As of December 31,

 
     2003

    2004

    2005

 

Current:

                        

Federal

   $ —       $ —       $ —    

State

     (871 )     (264 )     (88 )
    


 


 


Total Current

     (871 )     (264 )     (88 )
    


 


 


Deferred

                        

Federal and state

     (6,710 )     (7,815 )     (5,823 )
    


 


 


Valuation allowance

     6,710       7,815       5,823  

Total deferred

     —         —         —    
    


 


 


Total provision

   $ (871 )   $ (264 )   $ (88 )
    


 


 


 

A reconciliation of the provision for income taxes at statutory rates to the provision in the financial statement is as follows:

 

     Years Ended December 31,

 
     2003

    2004

    2005

 

Federal statutory rate

   (34.0 )%   (34.0 )%   (34.0 )%

State tax, net of federal benefit

   (5.0 )%   (5.0 )%   (5.0 )%

Other

   0.1 %   0.1 %   0.1 %

Valuation allowance

   38.9 %   38.9 %   38.9 %

Research & development credit saleback

   (5.2 )%   (1.5 )%   (0.6 )%
    

 

 

     (5.2 )%   (1.5 )%   (0.6 )%
    

 

 

 

F-29


Table of Contents

Achillion Pharmaceuticals, Inc.

 

Notes to Financial Statements—(Continued)

(in thousands, except per share amounts)

 

14. Subsequent Events

 

On September 18, 2006, the Company’s Board of directors approved, subject to stockholder approval, a 1-for-8 reverse stock split of the outstanding common stock to be effected before completion of this offering. As a result, the conversion ratios of the Company’s preferred stock changed as follows:

 

     Prior

   After

Series A

   1 : 1    1 : 0.1250

Series B

   1 : 1    1 : 0.1250

Series C

   1 : 1.196    1 : 0.1495

Series C-1

   1 : 1.196    1 : 0.1495

Series C-2

   1 : 1    1 : 0.1250

 

F-30


Table of Contents

 

4,500,000 Shares

 

 

LOGO

 

Common Stock

 


 

PROSPECTUS

 


 

Cowen and Company

CIBC World Markets

JMP Securities

 

, 2006

 

Until                     , 2006, all dealers that effect transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This requirement is in addition to the dealers’ obligation to deliver a prospectus when acting as underwriters and with respect to their unsold allotments or subscriptions.

 



Table of Contents

PART II

 

INFORMATION NOT REQUIRED IN PROSPECTUS

 

Item 13. Other Expenses of Issuance and Distribution.

 

The following table indicates the expenses to be incurred in connection with the offering described in this Registration Statement, other than underwriting discounts and commissions, all of which will be paid by Achillion. All amounts are estimates, other than the SEC registration fee, the NASD filing fee and the NASDAQ Global Market listing fee:

 

SEC registration fee

   $ 8,860

NASD filing fee

     8,263

NASDAQ Global Market listing fee

     100,000

Printing and engraving expenses

     200,000

Legal fees and expenses

     850,000

Accounting fees and expenses

     500,000

Transfer agent and registrar fees and expenses

     1,500

Miscellaneous

     31,377
    

Total

   $ 1,700,000
    

 

Item 14. Indemnification of Directors and Officers.

 

Section 102 of the Delaware General Corporation Law allows a corporation to eliminate the personal liability of directors of a corporation to the corporation or its stockholders for monetary damages for a breach of fiduciary duty as a director, except where the director breached his duty of loyalty, failed to act in good faith, engaged in intentional misconduct or knowingly violated a law, authorized the payment of a dividend or approved a stock repurchase in violation of Delaware corporate law or obtained an improper personal benefit. We have included such a provision in our Restated Certificate of Incorporation.

 

Section 145 of the Delaware General Corporation Law provides that a corporation has the power to indemnify a director, officer, employee or agent of the corporation and certain other persons serving at the request of the corporation in related capacities against amounts paid and expenses incurred in connection with an action or proceeding to which he is or is threatened to be made a party by reason of such position, if such person shall have acted in good faith and in a manner he reasonably believed to be in or not opposed to the best interests of the corporation, and, in any criminal proceeding, if such person had no reasonable cause to believe his conduct was unlawful; provided that, in the case of actions brought by or in the right of the corporation, no indemnification shall be made with respect to any matter as to which such person shall have been adjudged to be liable to the corporation unless and only to the extent that the adjudicating court determines that such indemnification is proper under the circumstances.

 

Our Restated Certificate of Incorporation includes a provision that eliminates the personal liability of its directors for monetary damages for breach of fiduciary duty as a director, except for liability:

 

    for any breach of the director’s duty of loyalty to Achillion or its stockholders;

 

    for acts or omissions not in good faith or that involve intentional misconduct or a knowing violation of law;

 

    under section 174 of the Delaware General Corporation Law regarding unlawful dividends and stock purchases; or

 

    for any transaction from which the director derived an improper personal benefit.

 

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These provisions are permitted under Delaware law. Our Restated Certificate of Incorporation provides that:

 

    we must indemnify our directors and officers to the fullest extent permitted by Delaware law;

 

    we may, to the extent authorized from time to time by our Board of Directors, indemnify our other employees and agents to the same extent that we indemnified our officers and directors; and

 

    in the event we do not assume the defense in a legal proceeding, we must advance expenses, as incurred, to our directors and executive officers in connection with a legal proceeding to the fullest extent permitted by Delaware law.

 

The indemnification provisions contained in our Restated Certificate of Incorporation and Amended and Restated Bylaws are not exclusive of any other rights to which a person may be entitled by law, agreement, vote of stockholders or disinterested directors or otherwise.

 

In addition, we maintain insurance on behalf of our directors and executive officers insuring them against any liability asserted against them in their capacities as directors or officers or arising out of such status.

 

Item 15. Recent Sales of Unregistered Securities .

 

Set forth below is information regarding shares of common stock and convertible preferred stock issued, and options and warrants granted, by the Registrant within the past three years. Also included is the consideration, if any, received by the Registrant for such shares, options and warrants and information relating to the section of the Securities Act, or rule of the Securities and Exchange Commission under which exemption from registration was claimed. The share numbers below reflect the 1-for-8 reverse stock split of the Registrant’s common stock, which will become effective prior to the closing of this offering.

 

1. On November 24, 2004, the Registrant issued an aggregate of 2,300,437 shares of series C-1 convertible preferred stock at a price per share of $2.1735 to Gilead Sciences, Inc. Upon the closing of this offering, these shares, together with the shares of series C-1 convertible preferred stock to be issued in satisfaction of accumulated dividends on the series C-1 convertible preferred stock (assuming for this purpose that the closing of the offering occurs on October 16, 2006), will automatically convert into 369,934 shares of common stock.

 

2. On November 17, 2005, March 22, 2006 and May 12, 2006, the Registrant sold an aggregate of 23,425,462 shares of series C-2 convertible preferred stock to a group of 35 investors at a price per share of $1.50. Upon the closing of this offering, these shares, together with the shares of series C-2 convertible preferred stock to be issued in satisfaction of accumulated dividends on the series C-2 convertible preferred stock (assuming for this purpose that the closing of the offering occurs on October 16, 2006), will automatically convert into 3,087,614 shares of common stock. The investors consisted of SGC Partners I LLC, Stelios Papadopoulos, Bear Stearns Health Innoventures, L.P., Bear Stearns Health Innoventures Offshore, L.P., BSHI Members, L.L.C., Bear Stearns Health Innoventures Employee Fund, L.P., BX, L.P., Schroder Ventures International Life Sciences Fund II LP1, Schroder Ventures International Life Sciences Fund II LP2, Schroder Ventures International Life Sciences Fund II LP3, Schroder Ventures International Life Sciences Fund II Strategic Partners L.P., Schroder Ventures International Life Sciences Fund II Group Co-Investment Scheme, SV (Nominees) Limited as nominee for Schroder Ventures Investments Limited, Connecticut Innovations, Incorporated, Advent Partners HLS II Limited Partnership, Advent Partners Limited Partnership, Advent Healthcare and Life Sciences II Limited Partnership, Advent Healthcare and Life Sciences II Beteiligung GMBH & Co. KG, Atlas Venture Entrepreneurs’ Fund V, L.P., Atlas Venture Fund V, L.P., Atlas Venture Parallel Fund V-A, C.V., Atlas Venture Parallel Fund V-B, C.V., Scheer Investment Holdings III, L.L.C., Barbara Piette, PGE Investments 2002, LLC, KBL Healthcare, L.P., KBL Partnership, L.P., Gilead Sciences, Inc., International Biotechnology Private ltd., Pound Capital Corporation, Capital Ventures International, Christopher White, Peter Reikes, David Malcolm and Kim Fennebresque.

 

3. On July 12, 2004 and October 28, 2004, the Registrant sold convertible promissory notes for an aggregate purchase price of $10,410,706 to a group of 27 investors. In November 2005, the convertible notes,

 

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along with accrued but unpaid interest, converted into an aggregate of 7,592,128 shares of series C-2 convertible preferred stock at a conversion price of $1.50 per share. In connection with the issuance of the convertible promissory notes, the Registrant issued warrants for the purchase of shares of its common stock. Upon conversion of the convertible promissory notes, these warrants became exercisable for an aggregate of 248,684 shares of common stock at an exercise price of $4.00 per share. The investors consisted of Advent Partners HLS II Limited Partnership, Advent Partners Limited Partnership, Advent Healthcare and Life Sciences II Limited Partnership, Advent Healthcare and Life Sciences II Beteiligung GMBH & Co. KG, Atlas Entrepreneurs’ Fund V, L.P., Altas Venture Fund V, LP, Atlas Venture Parallel Fund V-A, C.V., Atlas Venture Parallel Fund V-B, C.V., SGC Partners I LLC, Stelios Papadopoulos, Bear Stearns Health Innoventures, L.P., Bear Stearns Health Innoventures Offshore, L.P., BSHI Members, L.L.C., Bear Stearns Health Innoventures Employee Fund, L.P., BX, L.P., Schroder Ventures International Life Sciences Fund II LP1, Schroder Ventures International Life Sciences Fund II LP2, Schroder Ventures International Life Sciences Fund II LP3, Schroder Ventures International Life Sciences Fund II Strategic Partners L.P., Schroder Ventures International Life Sciences Fund II Group Co-Investment Scheme, SV (Nominees) Limited as nominee for Schroder Ventures Investments Limited, Schroder Ventures Investments Limited, Connecticut Innovations, Incorporated, Scheer Investment Holdings III, L.L.C., Barbara Piette, PGE Investments 2002, LLC, KBL Healthcare, L.P. and KBL Partnership, L.P.

 

4. On December 30, 2005, the Registrant issued warrants to purchase an aggregate of 166,666 shares of series C-2 convertible preferred stock at an exercise price of $1.50 per share. Upon the closing of this offering, these warrants will become exercisable for 20,832 shares of common stock at an exercise price of $12.00 per share. The warrants were issued to General Electric Capital Corporation and Oxford Finance Corporation.

 

5. On May 12, 2006, the Registrant issued warrants to purchase an aggregate of 166,666 shares of series C-2 convertible preferred stock at an exercise price of $1.50 per share. Upon the closing of this offering, these warrants will become exercisable for 20,832 shares of common stock at an exercise price of $12.00 per share. The warrants were issued to General Electric Capital Corporation and Oxford Finance Corporation.

 

6. From the period beginning September 15, 2003 through September 15, 2006, the Registrant has granted stock options under its stock option plans for an aggregate of 596,174 shares of common stock (net of exercises, expirations and cancellations) at exercise prices ranging from $1.60 to $9.00 per share. Options to purchase 21,419 shares of common stock have been exercised for an aggregate purchase price of $34,270.

 

No underwriters were involved in the foregoing sales of securities. The securities described in paragraphs 1 through 5 of Item 15 were issued to a combination of foreign and U.S. investors in reliance upon exemptions from the registration provisions of the Securities Act set forth in Section 4(2) or Regulation S thereof relative to sales by an issuer not involving any public offering, to the extent an exemption from such registration was required. All purchasers of shares of our convertible preferred stock and warrants described above represented to us in connection with their purchase that they were accredited investors or qualified institutional buyers and were acquiring the shares for investment and not distribution, that they could bear the risks of the investment and could hold the securities for an indefinite period of time. Such purchasers received written disclosures that the securities had not been registered under the Securities Act and that any resale must be made pursuant to a registration or an available exemption from such registration.

 

The issuance of stock options and the common stock issuable upon the exercise of such options as described in paragraph 6 of Item 15 were issued pursuant to written compensatory plans or arrangements with our employees, directors and consultants, in reliance on the exemption provided by Rule 701 promulgated under the Securities Act.

 

All of the foregoing securities are deemed restricted securities for purposes of the Securities Act. All certificates representing the issued shares of common stock described in this Item 15 included appropriate legends setting forth that the securities had not been registered and the applicable restrictions on transfer.

 

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Item 16. Exhibits and Financial Statement Schedules.

 

(a) Exhibits

 

Exhibit

No.


  

Description


  1.1    Form of Underwriting Agreement.
  3.1*    Amended and Restated Certificate of Incorporation of the Registrant, as amended.
  3.2*    Amended and Restated Bylaws.
  3.3    Form of Certificate of Amendment of Certificate of Incorporation of the Registrant to be effective immediately prior to effectiveness of this Registration Statement.
  3.4    Form of Amended and Restated Certificate of Incorporation of the Registrant to be effective upon closing of the offering.
  3.5    Form of Amended and Restated Bylaws of the Registrant to be effective upon closing of the offering.
  4.1    Specimen Certificate evidencing shares of common stock.
  5.1    Opinion of Wilmer Cutler Pickering Hale and Dorr LLP.
10.1†    Research Collaboration and License Agreement, dated November 24, 2004, by and between the Registrant and Gilead Sciences, Inc.
10.2*†    License Agreement, dated February 3, 2000, by and between Vion Pharmaceuticals, Inc. and the Registrant, as amended on January 28, 2002.
10.3*†    License Agreement, dated July 19, 2002 by and between the Registrant and Emory University.
10.4*†    License Agreement, dated November 15, 2002, by and between The University of Maryland and the Registrant.
10.5*    Employment Agreement between the Registrant and Michael Kishbauch, dated as of July 19, 2004.
10.6*    Employment Agreement between the Registrant and Milind Desphande, dated as of September 10, 2003, as amended January 1, 2006.
10.7*    Employment Agreement between the Registrant and John C. Pottage, dated as of September 10, 2003, as amended January 1, 2006.
10.8*    Employment Agreement between the Registrant and Kevin Eastwood, dated as of September 10, 2003, as amended January 1, 2006.
10.9*    Employment Agreement between the Registrant and Gautam Shah, dated as of May 26, 2004, as amended January 1, 2006.
10.10*    Second Amended and Restated Investor Rights Agreement, dated as of November 17, 2005, by and among the Registrant and the Holders named therein.
10.11*    Third Amended and Restated Stockholders’ Agreement, dated as of November 17, 2005, by and among the Registrant and the Stockholders named therein.
10.12*    Promissory Notes and Master Security Agreement by and between the Registrant and Oxford Finance Corporation, dated as of December 30, 2005.
10.13*    Promissory Notes and Master Security Agreement by and between the Registrant and GE Capital Corporation, dated as of January 24, 2002, as amended.
10.14*    Lease Agreement by and between the Registrant and WE George Street LLC for Suite 202, dated as of March 6, 2002.
10.15*    Lease Agreement by and between the Registrant and WE George Street LLC, dated as of May, 2000.

 

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Exhibit

No.


  

Description


10.16*    Lease Agreements and subsequent Assignment and Assumption of Lease Agreements by and between the Registrant, Yale University and WE George Street LLC for Suites 802, 803, 804.
10.17*    1998 Stock Option Plan, as amended.
10.18    2006 Stock Incentive Plan, as amended.
10.19*    Form of Incentive Stock Option Agreement for Executives under the 1998 Stock Option Plan.
10.20*    Form of Incentive Stock Option Agreement for Non-Executives under the 1998 Stock Option Plan.
10.21*    Form of Nonstatutory Stock Option Agreement under the 1998 Stock Option Plan.
10.22*    Form of Incentive Stock Option Agreement under the 2006 Stock Incentive Plan.
10.23*    Form of Nonstatutory Stock Option Agreement under the 2006 Stock Incentive Plan.
10.24    2006 Employee Stock Purchase Plan, as amended.
10.25*    Form of Common Stock Warrant.
10.26*    Form of Series C-2 Convertible Preferred Stock Warrant.
10.27*    Promissory Notes and Master Security Agreement by and between the Registrant and Webster Bank, dated as of May 15, 2003, as amended by the First, Second, Third and Fourth Amendments to Master Security Agreement, dated May 15, 2003, October 29, 2004, March 24, 2005 and August 7, 2006, respectively.
10.28*    Loan Agreement by and between the Registrant and Connecticut Innovations, Incorporated, dated March 30, 2001.
10.29   

Common Stock Warrants issued to Connecticut Innovations, Inc. on March 29, 2001 and November 7, 2000.

23.1    Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting Firm.
23.2    Consent of Wilmer Cutler Pickering Hale and Dorr LLP (included in Exhibit 5.1).
23.3*    Consent of Fletcher Spaght, Inc.
24.1*    Power of Attorney.

* Previously filed.
Confidential treatment requested as to certain portions, which portions have been filed separately with the Securities and Exchange Commission.

 

(b) Financial Statement Schedules.

 

None

 

Item 17. Undertakings.

 

The undersigned 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 of 1933 may be permitted to directors, officers, and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant 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 by the registrant against such liabilities (other than the payment by the registrant of expenses

 

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incurred or paid by a director, officer, or controlling person of the registrant 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, the registrant 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 of 1933, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant 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 of 1933, 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 the 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, the registrant has duly caused this amendment no. 4 to Registration Statement on Form S-1 to be signed on its behalf by the undersigned, thereunto duly authorized, in New Haven, Connecticut on September 21, 2006.

 

A CHILLION P HARMACEUTICALS , I NC .

By:

 

/ S /    M ICHAEL D. K ISHBAUCH


   

Michael D. Kishbauch

President and Chief Executive Officer

 

Pursuant to the requirements of the Securities Act of 1933, this amendment no. 4 to registration statement has been signed by the following persons in the capacities and on the dates indicated.

 

Name


  

Title


   Date

/ S /    M ICHAEL D. K ISHBAUCH


Michael D. Kishbauch

  

President and Chief Executive Officer and Director
(principal executive officer)

   September 21, 2006

/ S /    M ARY K AY F ENTON


Mary Kay Fenton

  

Vice President and Chief Financial Officer
(principal financial and accounting officer)

   September 21, 2006

*


James Garvey

  

Director

   September 21, 2006

*


Jason Fisherman, M.D.

  

Director

   September 21, 2006

*


Jean-Francois Formela, M.D.

  

Director

   September 21, 2006

*


Michael Grey

  

Director

   September 21, 2006

*


David Scheer

  

Director

   September 21, 2006

*


Stefan Ryser, Ph.D.

  

Director

   September 21, 2006

*


Christopher White

  

Director

   September 21, 2006

* B Y : / S /    M ARY K AY F ENTON


Mary Kay Fenton

Attorney-in-Fact

         

 

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EXHIBIT INDEX

 

Exhibit
No.


  

Description


  1.1    Form of Underwriting Agreement.
  3.1*    Amended and Restated Certificate of Incorporation of the Registrant, as amended.
  3.2*    Amended and Restated Bylaws.
  3.3    Form of Certificate of Amendment of Certificate of Incorporation of the Registrant to be effective immediately prior to effectiveness of this Registration Statement.
  3.4    Form of Amended and Restated Certificate of Incorporation of the Registrant to be effective upon closing of the offering.
  3.5    Form of Amended and Restated Bylaws of the Registrant to be effective upon closing of the offering.
  4.1    Specimen Certificate evidencing shares of common stock.
  5.1    Opinion of Wilmer Cutler Pickering Hale and Dorr LLP.
10.1†    Research Collaboration and License Agreement, dated November 24, 2004, by and between the Registrant and Gilead Sciences, Inc.
10.2*†    License Agreement, dated February 3, 2000, by and between Vion Pharmaceuticals, Inc. and the Registrant, as amended on January 28, 2002.
10.3*†    License Agreement, dated July 19, 2002 by and between the Registrant and Emory University.
10.4*†    License Agreement, dated November 15, 2002, by and between The University of Maryland and the Registrant.
10.5*    Employment Agreement between the Registrant and Michael Kishbauch, dated as of July 19, 2004.
10.6*    Employment Agreement between the Registrant and Milind Desphande, dated as of September 10, 2003, as amended January 1, 2006.
10.7*    Employment Agreement between the Registrant and John C. Pottage, dated as of September 10, 2003, as amended January 1, 2006.
10.8*    Employment Agreement between the Registrant and Kevin Eastwood, dated as of September 10, 2003, as amended January 1, 2006.
10.9*    Employment Agreement between the Registrant and Gautam Shah, dated as of May 26, 2004, as amended January 1, 2006.
10.10*    Second Amended and Restated Investor Rights Agreement, dated as of November 17, 2005, by and among the Registrant and the Holders named therein.
10.11*    Third Amended and Restated Stockholders’ Agreement, dated as of November 17, 2005, by and among the Registrant and the Stockholders named therein.
10.12*    Promissory Notes and Master Security Agreement by and between the Registrant and Oxford Finance Corporation, dated as of December 30, 2005.
10.13*    Promissory Notes and Master Security Agreement by and between the Registrant and GE Capital Corporation, dated as of January 24, 2002, as amended.
10.14*    Lease Agreement by and between the Registrant and WE George Street LLC for Suite 202, dated as of March 6, 2002.
10.15*    Lease Agreement by and between the Registrant and WE George Street LLC, dated as of May, 2000.


Table of Contents
Exhibit
No.


  

Description


10.16*    Lease Agreements and subsequent Assignment and Assumption of Lease Agreements by and between the Registrant, Yale University and WE George Street LLC for Suites 802, 803, 804.
10.17*    1998 Stock Option Plan, as amended, dated March 30, 2001.
10.18    2006 Stock Incentive Plan as amended.
10.19*    Form of Incentive Stock Option Agreement under the 1998 Stock Option Plan.
10.20*    Form of Incentive Stock Option Agreement for Non-Executives under the 1998 Stock Option Plan.
10.21*    Form of Nonstatutory Stock Option Agreement under the 1998 Stock Option Plan.
10.22*    Form of Incentive Stock Option Agreement under the 2006 Stock Incentive Plan.
10.23*    Form of Nonstatutory Stock Option Agreement under the 2006 Stock Incentive Plan.
10.24    2006 Employee Stock Purchase Plan as amended.
10.25*    Form of Common Stock Warrant.
10.26*    Form of Series C-2 Convertible Preferred Stock Warrant.
10.27*    Promissory Notes and Master Security Agreement by and between the Registrant and Webster Bank, dated as of May 15, 2003, as amended by the First, Second, Third and Fourth Amendments to Master Security Agreement, dated May 15, 2003, October 29, 2004, March 24, 2005 and August 7, 2006, respectively.
10.28*    Loan Agreement by and between the Registrant and Connecticut Innovations, Incorporated, dated March 30, 2001.
10.29   

Common Stock Warrants issued to Connecticut Innovations, Inc. on March 29, 2001 and November 7, 2000.

23.1    Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting Firm.
23.2    Consent of Wilmer Cutler Pickering Hale and Dorr LLP (included in Exhibit 5.1).
23.3*    Consent of Fletcher Spaght, Inc.
24.1*    Power of Attorney.

* Previously filed.
Confidential treatment requested as to certain portions, which portions have been filed separately with the Securities and Exchange Commission.

Exhibit 1.1

                     Shares

ACHILLION PHARMACEUTICALS, INC.

Common Stock

UNDERWRITING AGREEMENT

                             , 2006

COWEN AND COMPANY, LLC

CIBC WORLD MARKETS CORP.

JMP SECURITIES LLC

        As Representatives of the several Underwriters

        c/o Cowen and Company, LLC

1221 Avenue of the Americas

New York, New York 10020

Dear Sirs:

1. I NTRODUCTORY . Achillion Pharmaceuticals, Inc., a Delaware corporation (the “ Company ”), proposes to sell, pursuant to the terms of this Agreement, to the several underwriters named in Schedule A hereto (the “ Underwriters ,” or, each, an “ Underwriter ”), an aggregate of                      shares of Common Stock, $.001 par value (the “ Common Stock ”) of the Company. The aggregate of                      shares so proposed to be sold is hereinafter referred to as the “ Firm Stock ”. The Company also proposes to sell to the Underwriters, upon the terms and conditions set forth in Section 3 hereof, up to an additional                      shares of Common Stock (the “ Optional Stock ”). The Firm Stock and the Optional Stock are hereinafter collectively referred to as the “ Stock ”. Cowen and Company, LLC (“ Cowen ”), CIBC World Markets Corp. and JMP Securities LLC are acting as representatives of the several Underwriters and in such capacity are hereinafter referred to as the “ Representatives .”

The Company hereby confirms its engagement of CIBC World Markets Corp. (“ CIBC ”) and CIBC hereby confirms its agreement with the Company to render services as a “qualified independent underwriter” within the meaning of Rule 2720 of the Conduct Rules of the National Association of Securities Dealers, Inc. (“ NASD ”) with respect to the offering of the Stock. CIBC, solely in its capacity as the “qualified independent underwriter” with respect to the offering of the Stock, and not otherwise, is referred to herein as the “ QIU .”

2. R EPRESENTATIONS AND W ARRANTIES OF THE C OMPANY . The Company represents and warrants to, and agrees with, the several Underwriters and the QIU that as of the Applicable Time (as defined below in Section 2(c)(i)) and as of the date hereof:

(a) A registration statement on Form S-1 (File No. 333-132921) (the “ Initial Registration Statement ”) in respect of the Stock has been filed with the Securities and Exchange Commission (the “ Commission ”); the Initial Registration Statement and any post-effective amendment thereto, each in the form heretofore delivered to you, and, excluding exhibits thereto, to you for each of the other Underwriters, have been declared effective by the Commission in such form; other than a registration statement, if any, increasing the size of the offering (a “ Rule 462(b) Registration Statement ”), filed pursuant to Rule 462(b) under the Securities Act of 1933, as amended (the “ Securities Act ”) and the rules and regulations (the “ Rules and Regulations ”) of the Commission thereunder, which became effective upon filing, no other document with respect to the Initial Registration Statement has heretofore been filed with the Commission; and no stop order suspending the effectiveness of the Initial Registration Statement, any post-effective amendment thereto or the Rule 462(b) Registration Statement, if any, has been issued and no proceeding for that purpose has been initiated or, to the best knowledge of the Company, threatened by the


Commission (any preliminary prospectus included in the Initial Registration Statement or filed with the Commission pursuant to Rule 424(a) of the Rules and Regulations, is hereinafter called a “ Preliminary Prospectus ”); the various parts of the Initial Registration Statement and the Rule 462(b) Registration Statement, if any, including all exhibits thereto and including the information contained in the form of final prospectus filed with the Commission pursuant to Rule 424(b) under the Securities Act and deemed by virtue of Rule 430A under the Securities Act to be part of the Initial Registration Statement at the time it was declared effective, each as amended at the time such part of the Initial Registration Statement became effective or such part of the Rule 462(b) Registration Statement, if any, became or hereafter becomes effective, are hereinafter collectively called the “ Registration Statements ”; and such final prospectus, in the form first filed pursuant to Rule 424(b) under the Securities Act, is hereinafter called the “ Prospectus ”. No document has been or will be prepared or distributed in reliance on Rule 434 under the Securities Act. No order preventing or suspending the use of any Preliminary Prospectus has been issued by the Commission.

(b) The Initial Registration Statement conforms (and the Rule 462(b) Registration Statement, if any, the Prospectus and any amendments or supplements to either of the Registration Statements or the Prospectus, when they become effective or are filed with the Commission, as the case may be, will conform) in all material respects to the requirements of the Securities Act and the Rules and Regulations and do not and will not, as of the applicable effective date (as to the Registration Statements and any amendment thereto) and as of the applicable filing date (as to the Prospectus and any amendment or supplement thereto) contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein not misleading; provided , however , that the foregoing representations and warranties shall not apply to information contained in or omitted from the Registration Statements, any Issuer Free Writing Prospectus (as defined below) or the Prospectus or any such amendment or supplement thereto in reliance upon, and in conformity with, written information furnished to the Company through the Representatives by or on behalf of any Underwriter specifically for inclusion therein, which information the parties hereto agree is limited to the Underwriter’s Information (as defined in Section 17).

(c) As of the Applicable Time (as defined below), neither (x) the Issuer General Use Free Writing Prospectus(es) (as defined below) issued at or prior to the Applicable Time and the Statutory Prospectus (as defined below) as of the Applicable Time and the pricing information included on Schedule B hereto, all considered together (collectively, the “ General Disclosure Package ”), nor (y) any individual Issuer Limited Use Free Writing Prospectus (as defined below), when considered together with the General Disclosure Package, included or will include any untrue statement of a material fact or omitted or will omit to state any material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading.

As used in this subsection and elsewhere in this Agreement:

 

  (i) Applicable Time ” means                      (Eastern time) on                      or such other time as agreed by the Company and the Representatives.

 

  (ii) Issuer Free Writing Prospectus ” means any “issuer free writing prospectus,” as defined in Rule 433 of the Securities Act (“ Rule 433 ”), relating to the Stock that (a) is required to be filed with the Commission by the Company, (b) is a “road show that is a written communication” within the meaning of Rule 433(d)(8)(i) whether or not required to be filed with the Commission, or (c) is exempt from filing pursuant to Rule 433(d)(5)(i) because it contains a description of the Stock or of the offering that does not reflect the final terms, in each case in the form filed or required to be filed with the Commission or, if not required to be filed, in the form required to be retained in the Company’s records pursuant to Rule 433(g).

 

  (iii) Issuer General Use Free Writing Prospectus ” means any Issuer Free Writing Prospectus that is intended for general distribution to prospective investors (other than a Bona Fide Electronic Road Show (as defined below)), as evidenced by its being specified in Schedule C hereto.

 

2


  (iv) Issuer Limited Use Free Writing Prospectus ” means any Issuer Free Writing Prospectus that is not an Issuer General Use Free Writing Prospectus.

 

  (v) Statutory Prospectus ” as of any time means the prospectus relating to the Stock that is included in the Initial Registration Statement immediately prior to that time.

(d) The Company has complied with the filing requirements under Rule 433(d) of the Securities Act with respect to each Issuer Free Writing Prospectus.

(e) The Company has made available a “ bona fide electronic road show,” as defined in Rule 433, in compliance with Rule 433(d)(8)(ii) (the “ Bona Fide Electronic Road Show ”) such that no filing of any “road show” (as defined in Rule 433(h)) is required in connection with the offering of the Stock.

(f) Each Issuer Free Writing Prospectus, as of its issue date and at all subsequent times through the completion of the public offer and sale of the Stock or until any earlier date that the issuer notified or notifies the Representatives as described in Section 4(b), did not, does not and will not include any information that conflicted, conflicts or will conflict with the information contained in the Registration Statements or the Prospectus, and any preliminary or other prospectus deemed to be a part thereof that has not been superseded or modified, and no Issuer Free Writing Prospectus contained or contains any untrue statement of a material fact or omitted or omits to state any material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. The Company has filed and will file with the Commission all Issuer Free Writing Prospectuses in the time and manner required under Rules 163(b)(2) and 433(d) under the Securities Act.

(g) At the time of filing the Initial Registration Statement, the 462(b) Registration Statement, if any, and any post effective amendments thereto, and as of the date hereof (with such date being used as the determination date), the Company was not and is not an “ineligible issuer” (as defined in Rule 405 under the Securities Act, without taking into account any determination by the Commission pursuant to Rule 405 under the Securities Act that it is not necessary that the Company be considered an ineligible issuer), including, without limitation, for purposes of Rules 164 and 433 under the Securities Act with respect to the offering of the Stock as contemplated by the Registration Statements.

(h) The Company has been duly incorporated and is validly existing as a corporation in good standing under the laws of its jurisdiction of incorporation, is duly qualified to do business and is in good standing as a foreign corporation in each jurisdiction in which its ownership or lease of property or the conduct of its businesses requires such qualification, and has all power and authority necessary to own or hold its properties and to conduct the business in which it is engaged, except where the failure to so qualify or have such power or authority would not have, singularly or in the aggregate, a material adverse effect on the condition (financial or otherwise), results of operations, business or prospects of the Company (a “ Material Adverse Effect ”). The Company has no subsidiaries (as defined in Section 15) and does not own or control, directly or indirectly, any corporation, partnership, limited liability partnership, limited liability company, associations or other entities.

(i) This Agreement has been duly authorized, executed and delivered by the Company.

(j) The Stock to be issued and sold by the Company to the Underwriters hereunder has been duly and validly authorized and, when issued and delivered against payment therefor as provided herein, will be duly and validly issued, fully paid and nonassessable and free of any preemptive or similar rights and will conform to the description thereof contained in the General Disclosure Package and the Prospectus.

(k) The Company has an authorized capitalization as set forth in the General Disclosure Package and the Prospectus, and all of the issued shares of capital stock of the Company, have been duly and validly authorized and issued, are fully paid and non-assessable, have been issued in compliance with federal and state securities laws, and conform to the description thereof contained in the General Disclosure Package and the Prospectus. None of the outstanding shares of Common Stock was issued in violation of any preemptive rights, rights of first refusal or other similar rights to subscribe for or purchase securities of the Company. There are no authorized or outstanding options, warrants, preemptive rights, rights of first

 

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refusal or other rights to purchase, or equity or debt securities convertible into or exchangeable or exercisable for, any capital stock of the Company other than those accurately described in the General Disclosure Package and the Prospectus. The description of the Company’s stock option, stock bonus and other stock plans or arrangements, and the options or other rights granted thereunder, as described in the General Disclosure Package and the Prospectus accurately and fairly present the information required to be shown with respect to such plans, arrangements, options and rights.

(l) The execution, delivery and performance of this Agreement by the Company and the consummation of the transactions contemplated hereby will not conflict with or result in a breach or violation of any of the terms or provisions of, or constitute a default under, any indenture, mortgage, deed of trust, loan agreement or other agreement or instrument to which the Company is a party or by which the Company is bound or to which any of the property or assets of the Company is subject, nor will such actions result in any violation of the provisions of the charter or by-laws of the Company or any statute or any order, rule or regulation of any court or governmental agency or body having jurisdiction over the Company or any of its properties or assets.

(m) Except for the registration of the Stock under the Securities Act and such consents, approvals, authorizations, registrations or qualifications as may be required under the Exchange Act and applicable state securities laws, the National Association of Securities Dealers, Inc. and the Nasdaq National Market in connection with the purchase and distribution of the Stock by the Underwriters, no consent, approval, authorization or order of, or filing or registration with, any such court or governmental agency or body is required for the execution, delivery and performance of this Agreement by the Company and the consummation of the transactions contemplated hereby.

(n) PricewaterhouseCoopers LLP, who have expressed their opinions on the audited financial statements and related schedules included in the Registration Statements, the General Disclosure Package and the Prospectus is an independent registered public accounting firm as required by the Securities Act and the Rules and Regulations and by the rules of the Public Company Accounting Oversight Board (the “ PCAOB ”).

(o) The financial statements, together with the related notes and schedules, included in the General Disclosure Package, the Prospectus and in each Registration Statement fairly present the financial position and the results of operations and changes in financial position of the Company at the respective dates or for the respective periods therein specified. Such statements and related notes and schedules have been prepared in accordance with generally accepted accounting principles applied on a consistent basis except as may be set forth in the General Disclosure Package and the Prospectus. The financial statements, together with the related notes and schedules, included in the General Disclosure Package and the Prospectus comply in all material respects with the Securities Act and the Rules and Regulations thereunder. The summary and selected financial data included in the Registration Statements, the General Disclosure Package and the Prospectus present fairly the information shown therein and have been compiled on a basis consistent with that of the audited financial information included in the Registration Statements, the General Disclosure Package and the Prospectus. No other financial statements (historical or pro forma) or supporting schedules or exhibits are required by the Securities Act or the Rules and Regulations thereunder to be included in the General Disclosure Package and the Prospectus.

(p) The Company has not sustained, since the date of the latest audited financial statements included in the General Disclosure Package and the Prospectus, any material loss or interference with its business from fire, explosion, flood or other calamity, whether or not covered by insurance, or from any labor dispute or court or governmental action, order or decree, otherwise than as set forth or contemplated in the Prospectus; and, since such date, there has not been any change in the capital stock or long-term debt of the Company (other than (i) issuance of Common Stock, if any, pursuant to the exercise of outstanding options or warrants described in the prospectus and (ii) the issuance of Series C-2 Convertible Preferred Stock and $5,000,000 in promissory notes on May 12, 2006, as described in the Prospectus) or any material adverse change, or any development involving a prospective material adverse change, in or affecting the business, financial position, stockholders’ equity or results of operations of the Company, otherwise than as set forth or contemplated in the Prospectus.

 

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(q) Except as set forth in the Prospectus, there is no legal or governmental proceeding pending to which the Company is a party or of which any property or assets of the Company is the subject which is required to be described in the Registration Statement, the General Disclosure Package or the Prospectus and is not described therein, or which, singularly or in the aggregate, if determined adversely to the Company, would reasonably be expected to have a Material Adverse Effect or would prevent or adversely affect the ability of the Company to perform its obligations under this Agreement; and to the best of the Company’s knowledge, no such proceedings are threatened or contemplated by governmental authorities or threatened by others.

(r) The Company is not (i) in violation of its charter or by-laws, (ii) in default in any respect, and no event has occurred which, with notice or lapse of time or both, would constitute such a default, in the due performance or observance of any term, covenant or condition contained in any indenture, mortgage, deed of trust, loan agreement or other agreement or instrument to which it is a party or by which it is bound or to which any of its property or assets is subject or (iii) in violation in any respect of any law, ordinance, governmental rule, regulation or court decree to which it or its property or assets may be subject, except, with respect to clauses (ii) and (iii), any violations or defaults which, singularly or in the aggregate, would not have a Material Adverse Effect.

(s) The Company possesses all licenses, certificates, authorizations and permits issued by, and has made all declarations and filings with, the appropriate state, federal and foreign regulatory agencies or bodies which are necessary or desirable for the ownership of its properties and the conduct of its business as described in the General Disclosure Package and the Prospectus except where any failures to possess or make the same, singularly or in the aggregate, would not have a Material Adverse Effect, including without limitation all such certificates, authorizations, filings, submissions and permits required by the United States Food and Drug Administration (the “ FDA ”) or any other federal, state or foreign agencies or bodies engaged in the regulation of pharmaceuticals or biohazardous materials, and the Company has not received notification of any revocation or modification of any such license, authorization or permit, and has no reason to believe that any such license, certificate, authorization or permit will not be renewed and, to the best knowledge of the Company, no party granting any such license, authorization or permit is considering limiting, suspending or revoking the same in any material respect. The Company has not failed to submit to the FDA an Investigational New Drug Application for each new drug for which it is sponsoring a clinical trial, except where such failure would not, singly or in the aggregate, have a Material Adverse Effect; all such submissions were in material compliance with applicable laws when submitted and no material deficiencies have been asserted by the FDA with respect to any such submissions, except any deficiencies which would not, singly or in the aggregate, have a Material Adverse Effect.

(t) The tests and preclinical studies and clinical trials conducted by or on behalf of the Company that are described in the Registration Statements, the General Disclosure Package and the Prospectus were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company; the descriptions of the results of such studies, tests and trials contained in the Registration Statements, the General Disclosure Package and the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading. There have been no studies, tests or trials conducted by or on behalf of the Company not described in the Registration Statements, the General Disclosure Package and the Prospectus the results of which reasonably call into question the results of the studies, tests and trials described in the Registration Statements, the General Disclosure Package or the Prospectus; and the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or requesting the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company which termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect on the Company.

(u) All statistical or market-related data included in the Registration Statements, the General Disclosure Package or the Prospectus are based on or derived from sources that the Company believes to be

 

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reliable and accurate, and the Company has obtained the written consent to the use of such data from such sources to the extent required.

(v) The Company is not, nor, after giving effect to the offering of the Stock and the application of the proceeds thereof as described in the Prospectus, will become an “investment company” within the meaning of the Investment Company Act of 1940, as amended and the rules and regulations of the Commission thereunder.

(w) Neither the Company nor any of its officers, directors or affiliates has taken or will take, directly or indirectly, any action designed or intended to stabilize or manipulate the price of any security of the Company, or which caused or resulted in, or which might in the future reasonably be expected to cause or result in, stabilization or manipulation of the price of any security of the Company.

(x) Except as described in the Registration Statements, the General Disclosure Package and the Prospectus, (a) the Company owns, possesses or has adequate rights to use the Company Intellectual Property (as defined below), (b) the Company has not received any notice of any infringement of, or conflict with, any intellectual property (as defined below) of any third party, (c) the Company is not aware of any third party, including any academic or governmental organization, which possesses or could obtain rights to the Company Intellectual Property which, if exercised, could enable such party to develop products competitive with those of the Company, and (d) the Company is not obligated to pay a material royalty, grant a material license, or provide other material consideration to any third party in connection with the Company Intellectual Property. Except as described in the Registration Statements, the General Disclosure Package and the Prospectus or as would not have a Material Adverse Effect, (x) the Company is not aware of any facts or circumstances that constitute an infringement by the Company of any valid claim of a third-party patent, (y) the Company is not aware of any facts or circumstances that constitute an infringement by the Company of, or conflict with, any non-patented intellectual property right of any third party, and (z) the Company is not aware of any facts or circumstances that would render any Company Intellectual Property invalid or unenforceable. For purposes of this Agreement, “i ntellectual property ” means patents, patent rights, patent applications, licenses, inventions, copyrights, know how (including trade secrets and other unpatented and/or unpatentable proprietary or confidential information, systems or procedures), trademarks, service marks and trade names, and “ Company Intellectual Property ” means intellectual property that is necessary to carry on the business now operated and as planned to be operated by the Company as described in the Prospectus.

(y) The Company has duly and properly filed or caused to be filed with the United States Patent and Trademark Office (the “ PTO ”) and applicable foreign and international patent authorities all patent applications owned by the Company (the “ Company Patent Applications ”). To the knowledge of the Company, the Company has complied with the PTO’s duty of candor and disclosure for the Company Patent Applications and has made no material misrepresentation in the Company Patent Applications. To the knowledge of the Company, the Company has complied with the duty of candor and disclosure for the Company Patent Applications pending in countries outside the United States. The Company is not aware of any information material to a determination of patentability regarding the Company Patent Applications not called to the attention of the PTO or similar foreign authority. The Company is not aware of any information not called to the attention of the PTO or similar foreign authority which would preclude the grant of a patent for the Company Patent Applications. The Company has no knowledge of any information which would preclude the Company from having clear title to the Company Patent Applications.

(z) The Company has good and marketable title in fee simple to, or has valid rights to lease or otherwise use, all items of real or personal property which are material to the business of the Company, in each case free and clear of all liens, encumbrances, claims and defects that may result in a Material Adverse Effect.

(aa) No labor disturbance by the employees of the Company exists or, to the best of the Company’s knowledge, is imminent which might be expected to have a Material Adverse Effect. The Company is not aware that any key employee or significant group of employees of the Company plans to terminate employment with the Company.

 

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(bb) No “prohibited transaction” (as defined in Section 406 of the Employee Retirement Income Security Act of 1974, as amended, including the regulations and published interpretations thereunder (“ ERISA ”), or Section 4975 of the Internal Revenue Code of 1986, as amended from time to time (the “ Code ”)) or “accumulated funding deficiency” (as defined in Section 302 of ERISA) or any of the events set forth in Section 4043(b) of ERISA (other than events with respect to which the 30-day notice requirement under Section 4043 of ERISA has been waived) has occurred with respect to any employee benefit plan which could have a Material Adverse Effect; each employee benefit plan is in compliance in all material respects with applicable law, including ERISA and the Code; the Company has not incurred and does not expect to incur liability under Title IV of ERISA with respect to the termination of, or withdrawal from, any “pension plan”; and each “pension plan” (as defined in ERISA) for which the Company would have any liability that is intended to be qualified under Section 401(a) of the Code is so qualified in all material respects and nothing has occurred, whether by action or by failure to act, which could cause the loss of such qualification.

(cc) The Company is in compliance with all foreign, federal, state and local rules, laws and regulations relating to the use, treatment, storage and disposal of hazardous or toxic substances or waste and protection of health and safety or the environment which are applicable to their businesses, except where the failure to comply would not, singularly or in the aggregate, have a Material Adverse Effect. There has been no storage, generation, transportation, handling, treatment, disposal, discharge, emission, or other release of any kind of toxic or other wastes or other hazardous substances by, due to, or caused by the Company (or, to the best of the Company’s knowledge, any other entity for whose acts or omissions the Company is or may be liable) upon any of the property now or previously owned or leased by the Company, or upon any other property, in violation of any statute or any ordinance, rule, regulation, order, judgment, decree or permit or which would, under any statute or any ordinance, rule (including rule of common law), regulation, order, judgment, decree or permit, give rise to any liability, except for any violation or liability which would not have, singularly or in the aggregate with all such violations and liabilities, a Material Adverse Effect; there has been no disposal, discharge, emission or other release of any kind onto such property or into the environment surrounding such property of any toxic or other wastes or other hazardous substances with respect to which the Company has knowledge, except for any such disposal, discharge, emission, or other release of any kind which would not have, singularly or in the aggregate with all such discharges and other releases, a Material Adverse Effect.

(dd) The Company (i) has filed with all necessary federal, state and foreign income and franchise tax returns, (ii) has paid all federal state, local and foreign taxes due and payable for which it is liable, and (iii) does not have any tax deficiency or claims outstanding or assessed or, to the best of the Company’s knowledge, proposed against it which could reasonably be expected to have a Material Adverse Effect.

(ee) The Company carries, or is covered by, insurance in such amounts and covering such risks as is adequate for the conduct of its business and the value of its properties and as is customary for companies engaged in similar businesses in similar industries.

(ff) The Company maintains a system of internal accounting controls sufficient to provide reasonable assurances that (i) transactions are executed in accordance with management’s general or specific authorization; (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with generally accepted accounting principles and to maintain accountability for assets; (iii) access to assets is permitted only in accordance with management’s general or specific authorization; and (iv) the recorded accountability for assets is compared with existing assets at reasonable intervals and appropriate action is taken with respect to any differences.

(gg) The minute books of the Company have been made available to the Underwriters and counsel for the Underwriters, and such books (i) contain a complete summary of all meetings and actions of the board of directors (including each board committee) and shareholders of the Company since the time of its respective incorporation through the date of the latest meeting and action, and (ii) accurately in all material respects reflect all transactions referred to in such minutes.

(hh) There is no franchise, lease, contract, agreement or document required by the Securities Act or by the Rules and Regulations to be described in the General Disclosure Package and the Prospectus or to be

 

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filed as an exhibit to the Registration Statements which is not described or filed therein as required; and all descriptions of any such franchises, leases, contracts, agreements or documents contained in the Registration Statements are accurate and complete descriptions of such documents in all material respects. Other than as described in the General Disclosure Package and the Prospectus, (i) no such franchise, lease, contract or agreement has been suspended or terminated for convenience or default by the Company or any of the other parties thereto, (ii) the Company has not received notice of any such pending or threatened suspension or termination and (iii) to the best knowledge of the Company no party to any such franchise, lease, contract or agreement is contemplating suspending or terminating such franchise, lease, contract or agreement, except for such pending or threatened suspensions or terminations that would not reasonably be expected to, singularly or in the aggregate, have a Material Adverse Effect.

(ii) No relationship, direct or indirect, exists between or among the Company on the one hand, and the directors, officers, stockholders, customers or suppliers of the Company on the other hand, which is required to be described in the General Disclosure Package and the Prospectus and which is not so described.

(jj) No person or entity has the right to require registration of shares of Common Stock or other securities of the Company because of the filing or effectiveness of the Registration Statements or otherwise, except for persons and entities who have expressly waived such right or who have been given timely and proper notice and have failed to exercise such right within the time or times required under the terms and conditions of such right.

(kk) The Company does not own any “margin securities” as that term is defined in Regulation U of the Board of Governors of the Federal Reserve System (the “ Federal Reserve Board ”), and none of the proceeds of the sale of the Stock will be used, directly or indirectly, for the purpose of purchasing or carrying any margin security, for the purpose of reducing or retiring any indebtedness which was originally incurred to purchase or carry any margin security or for any other purpose which might cause any of the Securities to be considered a “purpose credit” within the meanings of Regulation T, U or X of the Federal Reserve Board.

(ll) The Company is not a party to any contract, agreement or understanding with any person that would give rise to a valid claim against the Company or the Underwriters for a brokerage commission, finder’s fee or like payment in connection with the offering and sale of the Stock.

(mm) No forward-looking statement (within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act) contained in the General Disclosure Package or the Prospectus has been made or reaffirmed without a reasonable basis or has been disclosed other than in good faith.

(nn) The Stock has been approved for listing subject to notice of issuance on the Nasdaq Stock Market’s National Market (“ Nasdaq ”), and the Company is in compliance in all material respects with all corporate governance requirements set forth in the Nasdaq Marketplace Rules that are in effect and applicable to the Company as of the date hereof. A registration statement has been filed on Form 8-A pursuant to Section 12 of the Exchange Act, which registration statement complies in all material respects with the Exchange Act.

(oo) The Company is in compliance with all applicable provisions of the Sarbanes-Oxley Act of 2002 and all rules and regulations promulgated thereunder or implementing the provisions thereof (the “ Sarbanes-Oxley Act ”) that are in effect and applicable to the Company as of the date hereof.

(pp) Neither the Company, nor, to the best of the Company’s knowledge, any employee or agent of the Company, has made any contribution or other payment to any official of, or candidate for, any federal, state or foreign office in violation of any law or of the character required to be disclosed in the General Disclosure Package and the Prospectus.

(qq) There are no transactions, arrangements or other relationships between the Company and any of its affiliates (as such term is defined in Rule 405 of the Securities Act) or any unconsolidated entity, including, but not limited to, any structure finance, special purpose or limited purpose entity that could reasonably be

 

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expected to materially affect the Company’s liquidity or the availability of or requirements for its capital resources required to be described in the General Disclosure Package and the Prospectus which have not been described as required.

(rr) There are no outstanding loans, advances (except normal advances for business expense in the ordinary course of business) or guarantees or indebtedness by the Company to or for the benefit of any of the officers or directors of the Company, except as disclosed in the General Disclosure Package and the Prospectus.

Any certificate signed by or on behalf of the Company and delivered to the Representatives or to counsel for the Underwriters shall be deemed to be a representation and warranty by the Company to each Underwriter as to the matters covered thereby.

3. P URCHASE S ALE AND D ELIVERY OF O FFERED S ECURITIES . On the basis of the representations, warranties and agreements herein contained, but subject to the terms and conditions herein set forth, the Company agrees to sell to each Underwriter, and each Underwriter agrees, severally and not jointly, to purchase from the Company that number of shares of Firm Stock (rounded up or down, as determined by Cowen in its discretion, in order to avoid fractions) obtained by multiplying                      shares of Firm Stock by a fraction the numerator of which is the number of shares of Firm Stock set forth opposite the name of such Underwriter in Schedule A hereto and the denominator of which is the total number of shares of Firm Stock.

The purchase price per share to be paid by the Underwriters to the Company for the Stock will be $             per share (the “ Purchase Price ”).

The Company will deliver the Firm Stock to the Representatives for the respective accounts of the several Underwriters (in the form of definitive certificates, issued in such names and in such denominations as the Representatives may direct by notice in writing to the Company given at or prior to 12:00 Noon, New York time, on the second full business day preceding the First Closing Date (as defined below) against payment of the aggregate Purchase Price therefor by wire transfer to an account at a bank acceptable to Cowen, payable to the order of the Company, all at the offices of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., One Financial Center, Boston, MA 02110. Time shall be of the essence, and delivery at the time and place specified pursuant to this Agreement is a further condition of the obligations of each Underwriter hereunder. The time and date of the delivery and closing shall be at 10:00 A.M., New York time, on                     , 2006, in accordance with Rule 15c6-1 of the Exchange Act. The time and date of such payment and delivery are herein referred to as the “ First Closing Date ”. The First Closing Date and the location of delivery of, and the form of payment for, the Firm Stock may be varied by agreement between among the Company and Cowen.

The Company shall make the certificates for the Stock available to the Representatives for examination on behalf of the Underwriters in New York, New York at least twenty-four hours prior to the First Closing Date.

For the purpose of covering any over-allotments in connection with the distribution and sale of the Firm Stock as contemplated by the Prospectus, the Underwriters may purchase all or less than all of the Optional Stock. The price per share to be paid for the Optional Stock shall be the Purchase Price. The Company agrees to sell to the Underwriters the number of shares of Optional Stock specified in the written notice by Cowen described below and the Underwriters agree, severally and not jointly, to purchase such shares of Optional Stock. The option granted hereby may be exercised as to all or any part of the Optional Stock at any time, and from time to time, not more than thirty (30) days subsequent to the date of this Agreement. No Optional Stock shall be sold and delivered unless the Firm Stock previously has been, or simultaneously is, sold and delivered. The right to purchase the Optional Stock or any portion thereof may be surrendered and terminated at any time upon notice by Cowen to the Company.

The option granted hereby may be exercised by written notice being given to the Company by Cowen setting forth the number of shares of the Optional Stock to be purchased by the Underwriters and the date and time for delivery of and payment for the Optional Stock. Each date and time for delivery of and payment for the Optional Stock (which may be the First Closing Date, but not earlier) is herein called the “ Option Closing Date ” and shall in no event be earlier than two (2) business days nor later than five (5) business days after written notice is given. (The Option Closing Date and the First Closing Date are herein called the “ Closing Dates ”.)

 

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The Company will deliver the Optional Stock to the Underwriters (in the form of definitive certificates, issued in such names and in such denominations as the Representatives may direct by notice in writing to the Company given at or prior to 12:00 Noon, New York time, on the second full business day preceding the Option Closing Date against payment of the aggregate Purchase Price therefor in federal (same day) funds by certified or official bank check or checks or wire transfer to an account at a bank acceptable to Cowen payable to the order of the Company all at the offices of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., One Financial Center, Boston, MA 02110. Time shall be of the essence, and delivery at the time and place specified pursuant to this Agreement is a further condition of the obligations of each Underwriter hereunder. The Company shall make the certificates for the Optional Stock available to the Representatives for examination on behalf of the Underwriters in New York, New York not later than 10:00 A.M., New York Time, on the business day preceding the Option Closing Date. The Option Closing Date and the location of delivery of, and the form of payment for, the Optional Stock may be varied by agreement between the Company and Cowen.

The several Underwriters propose to offer the Stock for sale upon the terms and conditions set forth in the Prospectus.

4. F URTHER A GREEMENTS OF THE C OMPANY . The Company agrees with the several Underwriters and the QIU that:

(a) The Company will prepare the Rule 462(b) Registration Statement, if necessary, in a form approved by the Representatives and file such Rule 462(b) Registration Statement with the Commission on the date hereof; prepare the Prospectus in a form approved by the Representatives and file such Prospectus pursuant to Rule 424(b) under the Securities Act not later than the second business day following the execution and delivery of this Agreement; make no further amendment or any supplement to the Registration Statements or to the Prospectus prior to the Option Closing Date to which the Representatives shall reasonably object by notice to the Company after a reasonable period to review; advise the Representatives, promptly after it receives notice thereof, of the time when any amendment to either Registration Statement has been filed or becomes effective or any supplement to the General Disclosure Package, the Prospectus or any amended Prospectus has been filed and to furnish the Representatives with copies thereof; advise the Representatives, promptly after it receives notice thereof, of the issuance by the Commission of any stop order or of any order preventing or suspending the use of any Preliminary Prospectus, Issuer Free Writing Prospectus or the Prospectus, of the suspension of the qualification of the Stock for offering or sale in any jurisdiction, of the initiation or threatening of any proceeding for any such purpose, or of any request by the Commission for the amending or supplementing of the Registration Statements, the General Disclosure Package or the Prospectus or for additional information; and, in the event of the issuance of any stop order or of any order preventing or suspending the use of any Preliminary Prospectus or the Prospectus or suspending any such qualification, use promptly its best efforts to obtain its withdrawal.

(b) If at any time prior to the expiration of nine months after the effective date of the Initial Registration Statement when a prospectus relating to the Stock is required to be delivered any event occurs as a result of which the Prospectus as then amended or supplemented would include any untrue statement of a material fact, or omit to state any material fact necessary to make the statements therein, in light of the circumstances under which they were made, not misleading, or if it is necessary at any time to amend the Prospectus to comply with the Securities Act, the Company will promptly notify the Representatives thereof and upon their request will prepare an amended or supplemented Prospectus which will correct such statement or omission or effect such compliance. The Company will furnish without charge to each Underwriter and to any dealer in securities as many copies as the Representatives may from time to time reasonably request of such amended or supplemented Prospectus; and in case any Underwriter is required to deliver a prospectus relating to the Stock nine months or more after the effective date of the Initial Registration Statement, the Company upon the request of the Representatives and at the expense of such Underwriter will prepare promptly an amended or supplemented Prospectus as may be necessary to permit compliance with the requirements of Section 10(a)(3) of the Securities Act. If at any time following issuance of an Issuer Free Writing Prospectus there occurred or occurs an event or development as a result of which such Issuer Free Writing Prospectus conflicted or would conflict with the information contained in the Registration Statement relating to the Stock or included or would include an untrue statement of a material fact or omitted or would omit to state a material fact necessary in order to make the statements

 

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therein, in the light of the circumstances, prevailing at that subsequent time, not misleading, the Company will promptly notify the Representatives and will promptly amend or supplement, at its own expense, such Issuer Free Writing Prospectus to eliminate or correct such conflict, untrue statement or omission.

(c) To furnish promptly to each of the Representatives and to counsel for the Underwriters a signed copy of each of the Registration Statements as originally filed with the Commission, and each amendment thereto filed with the Commission, including all consents and exhibits filed therewith.

(d) To deliver promptly to the Representatives in New York City such number of the following documents as the Representatives shall reasonably request: (i) conformed copies of the Registration Statements as originally filed with the Commission and each amendment thereto (in each case excluding exhibits), (ii) each Preliminary Prospectus, (iii) each Issuer Free Writing Prospectus and (iv) the Prospectus (not later than 10:00 A.M., New York time, of the business day following the execution and delivery of this Agreement) and any amended or supplemented Prospectus (not later than 10:00 A.M., New York City time, on the business day following the date of such amendment or supplement).

(e) To make generally available to its shareholders as soon as practicable, but in any event not later than eighteen months after the effective date of the Registration Statement (as defined in Rule 158(c) under the Securities Act), an earnings statement of the Company and its subsidiaries (which need not be audited) complying with Section 11(a) of the Securities Act and the Rules and Regulations (including, at the option of the Company, Rule 158).

(f) The Company will promptly take from time to time such actions as the Representatives may reasonably request to qualify the Stock for offering and sale under the securities or Blue Sky laws of such jurisdictions as the Representatives may designate and to continue such qualifications in effect for so long as required for the distribution of the Stock; provided , that the Company shall not be obligated to qualify as a foreign corporation in any jurisdiction in which it is not so qualified or to file a general consent to service of process in any jurisdiction.

(g) During the period of five years from the date hereof, the Company will deliver to the Representatives and, upon request, to each of the other Underwriters, (i) as soon as they are available, copies of all reports or other communications furnished to shareholders and (i) as soon as they are available, copies of any reports and financial statements furnished or filed with the Commission pursuant to the Exchange Act or any national securities exchange or automatic quotation system on which the Stock is listed or quoted. The EDGAR filing or furnishing of any such report, communication or financial statement with the Commission under Section 13(a), 13(c), 14 or 15(d) of the Exchange Act shall be deemed to satisfy the requirement to deliver such report, communication or financial statement to the Representatives or Underwriters.

(h) The Company will not directly or indirectly offer, sell, assign, transfer, pledge, contract to sell, or otherwise dispose of any shares of Common Stock or securities convertible into or exercisable or exchangeable for Common Stock for a period of 180 days from the date of the Prospectus without the prior written consent of Cowen other than the Company’s sale of the Stock hereunder and the issuance of shares pursuant to employee benefit plans, qualified stock option plans or other employee compensation plans existing on the date hereof or pursuant to currently outstanding options, warrants or rights, provided, however, that if (i) the Company issues an earnings release or material news or a material event relating to the Company occurs during the last 17 days of the lock-up period, or (ii) prior to the expiration of the lock-up period, the Company announces that it will release earnings results during the 16-day period beginning on the last day of the lock-up period, the restrictions imposed by this section shall continue to apply until the expiration of the 18-day period beginning on the issuance of the earnings release or the occurrence of the material news or material event. The Company also agrees that during such period, the Company will not file any registration statement, preliminary prospectus or prospectus, or any amendment or supplement thereto, under the Securities Act for any such transaction or which registers, or offers for sale, Common Stock or any securities convertible into or exercisable or exchangeable for Common Stock, except for a registration statement on Form S-8 relating to employee benefit plans. The Company will cause each officer, director and shareholder listed in Schedule D to furnish to the Representatives, prior to the First Closing Date, a letter, substantially in the form of Exhibit I hereto, pursuant to which each such person

 

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shall agree not to directly or indirectly offer, sell, assign, transfer, pledge, contract to sell, or otherwise dispose of any shares of Common Stock or securities convertible into or exercisable or exchangeable for Common Stock for the period set forth therein, without the prior written consent of Cowen.

(i) The Company will supply the Representatives with copies of all correspondence to and from, and all documents issued to and by, the Commission in connection with the registration of the Stock under the Securities Act.

(j) Prior to each of the Closing Dates the Company will furnish to the Representatives, as soon as they have been prepared, copies of any unaudited interim consolidated financial statements of the Company for any periods subsequent to the periods covered by the financial statements appearing in the Registration Statement and the Prospectus.

(k) Prior to each of the Closing Dates, the Company will not issue any press release or other communication directly or indirectly or hold any press conference with respect to the Company, its condition, financial or otherwise, or earnings, business affairs or business prospects (except for routine oral marketing communications in the ordinary course of business and consistent with the past practices of the Company and of which the Representatives are notified), without first providing written notification to the Representatives.

(l) In connection with the offering of the Stock, until Cowen shall have notified the Company of the completion of the resale of the Stock, the Company will not, and will cause its affiliated purchasers (as defined in Regulation M under the Exchange Act) not to, either alone or with one or more other persons, bid for or purchase, for any account in which it or any of its affiliated purchasers has a beneficial interest, any Stock, or attempt to induce any person to purchase any Stock; and not to, and to cause its affiliated purchasers not to, make bids or purchase for the purpose of creating actual, or apparent, active trading in or of raising the price of the Stock.

(m) The Company will not take any action prior to the Option Closing Date which would require the Prospectus to be amended or supplemented pursuant to Section 4(b).

(n) The Company shall at all times comply in all material respects with all applicable provisions of the Sarbanes-Oxley Act in effect from time to time.

(o) The Company will apply the net proceeds from the sale of the Stock as set forth in the Prospectus under the heading “Use of Proceeds”.

(p) The Company represents and agrees that, unless it obtains the prior consent of the Representatives, and each Underwriter represents and agrees that, unless it obtains the prior consent of the Company and the Representatives, it has not made and will not make any offer relating to the Stock that would constitute an “issuer free writing prospectus,” as defined in Rule 433, or that would otherwise constitute a “free writing prospectus,” as defined in Rule 405, required to be filed with the Commission. Any such free writing prospectus consented to by the Representatives or by the Company and the Representatives, as the case may be, is hereinafter referred to as a “ Permitted Free Writing Prospectus .” The Company represents that it has treated or agrees that it will treat each Permitted Free Writing Prospectus as an “issuer free writing prospectus,” as defined in Rule 433, and has complied and will comply with the requirements of Rule 433 applicable to any Permitted Free Writing Prospectus, including timely filing with the Commission where required, legending and record keeping.

5. P AYMENT OF E XPENSES . The Company agrees with the Underwriter and the QIU to pay (a) the costs incident to the authorization, issuance, sale, preparation and delivery of the Stock and any taxes payable in that connection; (b) the costs incident to the Registration of the Stock under the Securities Act; (c) the costs incident to the preparation, printing and distribution of the Registration Statement, Preliminary Prospectus, Prospectus, and Permitted Free Writing Prospectus any amendments and exhibits thereto and any costs associated with electronic delivery of any of the foregoing by the Underwriters to any investor (d) the costs of printing, reproducing and

 

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distributing, the “Agreement Among Underwriters” between the Representatives and the Underwriters, the Master Selected Dealers’ Agreement, the Underwriters’ Questionnaire and this Agreement by mail, telex or other means of communications; (e) the fees and expenses (including related fees and expenses of counsel for the Underwriters) incurred in connection with filings made with the National Association of Securities Dealers; (f) any applicable listing or other fees; (g) the fees and expenses of qualifying the Stock under the securities laws of the several jurisdictions as provided in Section 4(f) and of preparing, printing and distributing Blue Sky Memoranda and Legal Investment Surveys (including related fees and expenses of counsel to the Underwriters); (h) all fees and expenses of the registrar and transfer agent of the Stock; (i) any costs and expenses associated with the reforming of any contracts for sale of the Stock made by the Underwriters caused by a breach of the representations contained in Section 2(c), (j) the fees and expenses (including related reasonable fees and disbursements of its counsel) of the QIU incurred by the QIU in its capacity as a “qualified independent underwriter” within the meaning of Rule 2720 of the NASD’s Conduct Rules with respect to the offering of the Stock and (k) all other costs and expenses incident to the performance of the obligations of the Company under this Agreement (including, without limitation, the fees and expenses of the Company’s counsel and the Company’s independent accountants); provided , that, except as otherwise provided in this Section 5 and in Section 9, the Underwriters shall pay their own costs and expenses, including the fees and expenses of their counsel, any transfer taxes on the Stock which they may sell and the expenses of advertising any offering of the Stock made by the Underwriters.

6. C ONDITIONS OF U NDERWRITERS ’ O BLIGATIONS . The respective obligations of the several Underwriters hereunder are subject to the accuracy, when made and on each of the Closing Dates, of the representations and warranties of the Company contained herein, to the accuracy of the statements of the Company made in any certificates pursuant to the provisions hereof, to the performance by the Company of their obligations hereunder, and to each of the following additional terms and conditions:

(a) No stop order suspending the effectiveness of either the Registration Statements shall have been issued and no proceedings for that purpose shall have been initiated or threatened by the Commission, and any request for additional information on the part of the Commission (to be included in the Registration Statements or the Prospectus or otherwise) shall have been complied with to the reasonable satisfaction of the Representatives. The Rule 462(b) Registration Statement, if any, and the Prospectus shall have been timely filed with the Commission in accordance with Section 4(a).

(b) None of the Underwriters shall have discovered and disclosed to the Company on or prior to the Closing Date that any Registration Statement or any amendment or supplement thereto contains an untrue statement of a fact which, in the opinion of counsel for the Underwriters, is material or omits to state any fact which, in the opinion of such counsel, is material and is required to be stated therein or is necessary to make the statements therein not misleading, or that the General Disclosure Package, any Issuer Free Writing Prospectus or the Prospectus or any amendment or supplement thereto contains an untrue statement of fact which, in the opinion of such counsel, is material or omits to state any fact which, in the opinion of such counsel, is material and is necessary in order to make the statements, in light of the circumstances in which they were made, not misleading.

(c) All corporate proceedings and other legal matters incident to the authorization, form and validity of each of this Agreement, the Stock, the Registration Statement and the Prospectus and all other legal matters relating to this Agreement and the transactions contemplated hereby shall be reasonably satisfactory in all material respects to counsel for the Underwriters, and the Company shall have furnished to such counsel all documents and information that they may reasonably request to enable them to pass upon such matters.

(d) Wilmer Cutler Pickering Hale and Dorr LLP shall have furnished to the Representatives such counsel’s written opinion, as counsel to the Company, addressed to the Underwriters and dated the Closing Date, in form and substance reasonably satisfactory to the Representatives and their counsel.

 

  (e)      (i) Wilmer Cutler Pickering Hale and Dorr LLP shall have furnished to the Representatives such counsel’s written opinion, as intellectual property counsel to the Company, addressed to the Underwriters and dated the Closing Date, in form and substance reasonably satisfactory to the Representatives and their counsel.

 

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  (ii) Cantor Colburn LLP shall have furnished to the Representatives such counsel’s written opinion, as intellectual property counsel to the Company, addressed to the Underwriters and dated the Closing Date, in form and substance reasonably satisfactory to the Representatives and their counsel.

(f) The Company shall have furnished to the Representatives a certificate, dated the Closing Date, of its Vice President, Regulatory Affairs stating that:

 

  (i) The Company is not in breach or violation of, or in default under, the Federal Food, Drug and Cosmetic Act or the regulations promulgated thereunder or any comparable foreign law or regulation relating to the regulation of pharmaceutical products (the “ Food & Drug Laws ”) or rule or any decree, judgment or order applicable to the Company relating to Food & Drug Laws, except where such breach, violation or default would not, individually or in the aggregate, have a Material Adverse Effect.

 

  (ii) The Company has all licenses, certificates, authorizations, permits, consents and approvals (collectively “ Consents ”) and has made all necessary declarations and filings required under any Food & Drug Laws relating to the regulation of pharmaceutical products, including without limitation all such Consents required by the FDA, all of such Consents are valid and in full force and effect; except where such failure would not, individually or in the aggregate have a Material Adverse Effect; all such Consents are free and clear of any restrictions or conditions that are in addition to, or materially different from, those that may be applicable to similarly situated companies; and the Company is not in violation of, or in default under, nor has the Company received notification of any proceedings relating to revocation or modification of any such Consent or any Food & Drug Law or any decree, order or judgment applicable to the Company relating thereto and the Company has no reason to believe that any such Consent will not be renewed.

 

  (iii) The Company is in compliance with all applicable Food & Drug Laws governing its business; except where such failure would not, individually or in the aggregate have a Material Adverse Effect; all preclinical and clinical studies undertaken to support approval of products for commercialization have been conducted, to the knowledge of the undersigned, in compliance with all applicable federal, state or foreign laws, rules, orders or regulations, including current Good Laboratory and Good Clinical Practices in all material respects, no filing or submission to the FDA or any comparable foreign regulatory body that is intended to be the basis for any approval contains, to the knowledge of the undersigned, any material omission or material misstatement of fact or other false information.

 

  (iv) The Prospectus does not contain any untrue statement of a material fact related to FDA matters or omit to state a material fact relating to FDA matters necessary to make the statements therein, in light of the circumstances under which they were made, not misleading, and the General Disclosure Package and the Bona Fide Electronic Road Show, as of the Applicable Time, did not contain any untrue statement of a material fact related to FDA matters or omit to state any material fact related to FDA matters required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading.

(g) The Representatives shall have received from Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. counsel for the Underwriters, such opinion or opinions, dated the Closing Date, with respect to such matters as the Underwriters may reasonably require, and the Company shall have furnished to such counsel such documents as they request for enabling them to pass upon such matters.

(h) At the time of the execution of this Agreement, the Representatives shall have received from PricewaterhouseCoopers LLP a letter, addressed to the Underwriters and dated such date, in form and substance satisfactory to the Representatives (i) confirming that they are an independent registered public

 

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accounting firm with respect to the Company and its subsidiaries within the meaning of the Securities Act and the Rules and Regulations and the rules of the PCAOB and (ii) stating the conclusions and findings of such firm with respect to the financial statements and certain financial information contained or incorporated by reference in the General Disclosure Package and the Statutory Prospectus.

(i) On the Closing Date, the Representatives shall have received a letter (the “ bring-down letter ”) from PricewaterhouseCoopers LLP addressed to the Underwriters and dated the Closing Date confirming, as of the date of the bring-down letter (or, with respect to matters involving changes or developments since the respective dates as of which specified financial information is given in the Prospectus as of a date not more than three business days prior to the date of the bring-down letter), the conclusions and findings of such firm with respect to the financial information and other matters covered by its letter delivered to the Representatives concurrently with the execution of this Agreement pursuant to Section 6(h).

(j) The Company shall have furnished to the Representatives a certificate, dated the Closing Date, of its President and Chief Executive Officer and its Vice President, Finance and Administration stating that (i) such officers have carefully examined the Registration Statements, the General Disclosure Package and the Prospectus and, in their opinion, the Registration Statements as of their respective effective dates, the Prospectus, as of each such effective date, and the General Disclosure Package, as of the Applicable Time, did not include any untrue statement of a material fact and did not omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading, (ii) since the effective date of the Initial Registration Statement no event has occurred which should have been set forth in a supplement or amendment to the Registration Statements, the General Disclosure Package or the Prospectus, (iii) to the best of their knowledge after reasonable investigation, as of the Closing Date, the representations and warranties of the Company in this Agreement are true and correct and the Company has complied with all agreements and satisfied all conditions on its part to be performed or satisfied hereunder at or prior to the Closing Date, and (iv) subsequent to the date of the most recent financial statements included in the Prospectus, there has been no material adverse change in the financial position or results of operation of the Company, or any change, or any development including a prospective change, in or affecting the condition (financial or otherwise), results of operations, business or prospects of the Company, except as set forth in the Prospectus.

(k) Since the date of the latest audited financial statements included in the General Disclosure Package (i) the Company shall not have sustained any loss or interference with its business from fire, explosion, flood or other calamity, whether or not covered by insurance, or from any labor dispute or court or governmental action, order or decree, otherwise than as set forth or contemplated in the General Disclosure Package and the Prospectus and (ii) there shall not have been any change in the capital stock or long-term debt of the Company or any change, or any development involving a prospective change, in or affecting the business, general affairs, management, financial position, stockholders’ equity or results of operations of the Company, otherwise than as set forth or contemplated in the General Disclosure Package and the Prospectus, the effect of which, in any such case described in clause (i) or (ii), is, in the judgment of the Representatives, so material and adverse as to make it impracticable or inadvisable to proceed with the sale or delivery of the Stock on the terms and in the manner contemplated in the Prospectus.

(l) No action shall have been taken and no statute, rule, regulation or order shall have been enacted, adopted or issued by any governmental agency or body which would, as of the Closing Date, prevent the issuance or sale of the Stock or materially and adversely affect or potentially materially and adversely affect the business or operations of the Company; and no injunction, restraining order or order of any other nature by any federal or state court of competent jurisdiction shall have been issued as of the Closing Date which would prevent the issuance or sale of the Stock or materially and adversely affect or potentially materially and adversely affect the business or operations of the Company.

(m) Subsequent to the execution and delivery of this Agreement there shall not have occurred any of the following: (i) trading in securities generally on the New York Stock Exchange, Nasdaq or the American Stock Exchange or in the over-the-counter market, or trading in any securities of the Company on any exchange or in the over-the-counter market, shall have been suspended or minimum or maximum prices or maximum range for prices shall have been established on any such exchange or such market by the Commission, by such exchange or by any other regulatory body or governmental authority having

 

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jurisdiction, (ii) a banking moratorium shall have been declared by Federal or state authorities or a material disruption has occurred in commercial banking or securities settlement or clearance services in the United States, (iii) the United States shall have become engaged in hostilities, or the subject of an act of terrorism, or there shall have been an escalation in hostilities involving the United States, or there shall have been a declaration of a national emergency or war by the United States or (iv) there shall have occurred such a material adverse change in general economic, political or financial conditions (or the effect of international conditions on the financial markets in the United States shall be such) as to make it, in the judgment of the Representatives, impracticable or inadvisable to proceed with the sale or delivery of the Stock on the terms and in the manner contemplated in the General Disclosure Package and the Prospectus.

(n) Nasdaq shall have approved the Stock for listing, subject only to official notice of issuance and evidence of satisfactory distribution.

(o) Cowen shall have received the written agreements, substantially in the form of Exhibit I hereto, of the officers, directors and shareholders of the Company listed in Schedule D to this Agreement.

All opinions, letters, evidence and certificates mentioned above or elsewhere in this Agreement shall be deemed to be in compliance with the provisions hereof only if they are in form and substance reasonably satisfactory to counsel for the Underwriters.

7. I NDEMNIFICATION AND C ONTRIBUTION .

(a) The Company shall indemnify and hold harmless each Underwriter, its officers, employees, representatives and agents and each person, if any, who controls any Underwriter within the meaning of the Securities Act (collectively the “ Underwriter Indemnified Parties ” and, each an “ Underwriter Indemnified Party ”) against any loss, claim, damage or liability, joint or several, or any action in respect thereof, to which that Underwriter Indemnified Party may become subject, under the Securities Act or otherwise, insofar as such loss, claim, damage, liability or action arises out of or is based upon (i) any untrue statement or alleged untrue statement of a material fact contained in the Preliminary Prospectus, either of the Registration Statements, any Issuer Free Writing Prospectus or the Prospectus or in any amendment or supplement thereto, (ii) the omission or alleged omission to state in any Preliminary Prospectus, either of the Registration Statements, any Issuer Free Writing Prospectus or the Prospectus or in any amendment or supplement thereto a material fact required to be stated therein or necessary to make the statements therein not misleading or (iii) any act or failure to act, or any alleged act or failure to act, by any Underwriter in connection with, or relating in any manner to, the Stock or the offering contemplated hereby, and which is included as part of or referred to in any loss, claim, damage, liability or action arising out of or based upon matters covered by clause (i) or (ii) above ( provided , that the Company shall not be liable in the case of any matter covered by this clause (iii) to the extent that it is determined in a final judgment by a court of competent jurisdiction that such loss, claim, damage, liability or action resulted directly from any such act or failure to act undertaken or omitted to be taken by such Underwriter through its gross negligence or willful misconduct) and shall reimburse each Underwriter Indemnified Party promptly upon demand for any legal or other expenses reasonably incurred by that Underwriter Indemnified Party in connection with investigating or preparing to defend or defending against or appearing as a third party witness in connection with any such loss, claim, damage, liability or action as such expenses are incurred; provided , however , that the Company shall not be liable in any such case to the extent that any such loss, claim, damage, liability or action arises out of or is based upon (i) an untrue statement or alleged untrue statement in or omission or alleged omission from the Preliminary Prospectus, either of the Registration Statements, any Issuer Free Writing Prospectus or the Prospectus or any such amendment or supplement in reliance upon and in conformity with written information furnished to the Company through the Representatives by or on behalf of any Underwriter specifically for use therein, which information the parties hereto agree is limited to the Underwriter’s Information (as defined in Section 17).

The Company shall indemnify and hold harmless the QIU and its directors, officers, managers, members, employees, representatives and agents and each person, if any, who controls the QIU within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act (collectively the “ QIU Indemnified Parties ,” and each a “ QIU Indemnified Party ”) from and against any loss, claim, damage, expense or

 

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liability whatsoever (or any action, investigation or proceeding in respect thereof), joint or several, to which that QIU Indemnified Party may become subject, arising out of, or based upon, the QIU’s acting as a “qualified independent underwriter” (within the meaning of Rule 2720 to the NASD’s Conduct Rules) in connection with the offering contemplated by this Agreement, and shall reimburse each QIU Indemnified Party promptly upon demand for any legal fees or other expenses reasonably incurred by that QIU Indemnified Party in connection with investigating, or preparing to defend, or defending against, or appearing as a third party witness in respect of, or otherwise incurred in connection with, any such loss, claim, damage, expense, liability, action, investigation or proceeding, as such fees and expenses are incurred, provided, however, that the Company shall not be liable for any losses, claims, damages, liabilities, expenses, actions, investigations or proceedings to the extent that it is judicially determined in a final judgment by a court of competent jurisdiction to have resulted directly from the gross negligence or willful misconduct of the QIU.

This indemnity agreement is not exclusive and will be in addition to any liability which the Company might otherwise have and shall not limit any rights or remedies which may otherwise be available at law or in equity to each Underwriter Indemnified Party or the QIU Indemnified Party.

(b) Each Underwriter, severally and not jointly, shall indemnify and hold harmless the Company its officers, employees, representatives and agents, each of its directors and each person, if any, who controls the Company within the meaning of the Securities Act (collectively the “ Company Indemnified Parties ” and each a “ Company Indemnified Party ”) against any loss, claim, damage or liability, joint or several, or any action in respect thereof, to which the Company Indemnified Parties may become subject, under the Securities Act or otherwise, insofar as such loss, claim, damage, liability or action arises out of or is based upon (i) any untrue statement or alleged untrue statement of a material fact contained in the Preliminary Prospectus, either of the Registration Statements, any Issuer Free Writing Prospectus or the Prospectus or in any amendment or supplement thereto or (ii) the omission or alleged omission to state therein a material fact required to be stated therein or necessary to make the statements therein not misleading, but in each case only to the extent that the untrue statement or alleged untrue statement or omission or alleged omission was made in reliance upon and in conformity with written information furnished to the Company through the Representatives by or on behalf of that Underwriter specifically for use therein, and shall reimburse the Company Indemnified Parties for any legal or other expenses reasonably incurred by such parties in connection with investigating or preparing to defend or defending against or appearing as third party witness in connection with any such loss, claim, damage, liability or action as such expenses are incurred; provided , that the parties hereto hereby agree that such written information provided by the Underwriters consists solely of the Underwriter’s Information. This indemnity agreement is not exclusive and will be in addition to any liability which the Underwriters might otherwise have and shall not limit any rights or remedies which may otherwise be available at law or in equity to the Company Indemnified Parties.

(c) Promptly after receipt by an indemnified party under this Section 7 of notice of any claim or the commencement of any action, the indemnified party shall, if a claim in respect thereof is to be made against the indemnifying party under this Section 7, notify the indemnifying party in writing of the claim or the commencement of that action; provided , however , that the failure to notify the indemnifying party shall not relieve it from any liability which it may have under this Section 7 except to the extent it has been materially prejudiced by such failure; and, provided , further , that the failure to notify the indemnifying party shall not relieve it from any liability which it may have to an indemnified party otherwise than under this Section 7. If any such claim or action shall be brought against an indemnified party, and it shall notify the indemnifying party thereof, the indemnifying party shall be entitled to participate therein and, to the extent that it wishes, jointly with any other similarly notified indemnifying party, to assume the defense thereof with counsel reasonably satisfactory to the indemnified party. After notice from the indemnifying party to the indemnified party of its election to assume the defense of such claim or action, the indemnifying party shall not be liable to the indemnified party under this Section 7 for any legal or other expenses subsequently incurred by the indemnified party in connection with the defense thereof other than reasonable costs of investigation; provided , however , that any indemnified party shall have the right to employ separate counsel in any such action and to participate in the defense thereof but the fees and expenses of such counsel shall be at the expense of such indemnified party unless (i) the employment thereof has been specifically authorized by the indemnifying party in writing, (ii) such indemnified party shall have been advised by such counsel that there may be one or more legal defenses available to it which

 

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are different from or additional to those available to the indemnifying party and in the reasonable judgment of such counsel it is advisable for such indemnified party to employ separate counsel, (iii) such indemnified party is a QIU Indemnified Party that has been advised by its counsel that there may be one or more legal defenses available to the QIU Indemnified Parties that are different from or additional to those available to the other indemnified parties, or (iv) the indemnifying party has failed to assume the defense of such action and employ counsel reasonably satisfactory to the indemnified party, in which case, if such indemnified party notifies the indemnifying party in writing that it elects to employ separate counsel at the expense of the indemnifying party, the indemnifying party shall not have the right to assume the defense of such action on behalf of such indemnified party, it being understood, however, that the indemnifying party shall not, in connection with any one such action or separate but substantially similar or related actions in the same jurisdiction arising out of the same general allegations or circumstances, be liable for the reasonable fees and expenses of more than one separate firm of attorneys plus any local counsel at any time for all such indemnified parties, which firm shall be designated in writing by Cowen, if the indemnified parties under this Section 7 consist of any Underwriter Indemnified Party, or by the Company if the indemnified parties under this Section 7 consist of any Company Indemnified Parties. Each indemnified party, as a condition of the indemnity agreements contained in Sections 7(a) and 7(b), shall use all reasonable efforts to cooperate with the indemnifying party in the defense of any such action or claim. Subject to the provisions of Section 7(d) below, no indemnifying party shall be liable for any settlement of any such action effected without its written consent (which consent shall not be unreasonably withheld), but if settled with its written consent or if there be a final judgment for the plaintiff in any such action, the indemnifying party agrees to indemnify and hold harmless any indemnified party from and against any loss or liability by reason of such settlement or judgment.

(d) If at any time an indemnified party shall have requested that an indemnifying party reimburse the indemnified party for fees and expenses of counsel, such indemnifying party agrees that it shall be liable for any settlement of the nature contemplated by this Section 7 effected without its written consent if (i) such settlement is entered into more than 45 days after receipt by such indemnifying party of the request for reimbursement, (ii) such indemnifying party shall have received notice of the terms of such settlement at least 30 days prior to such settlement being entered into and (iii) such indemnifying party shall not have reimbursed such indemnified party in accordance with such request prior to the date of such settlement.

(e) If the indemnification provided for in this Section 7 is unavailable or insufficient to hold harmless an indemnified party under Section 7(a) or 7(b), then each indemnifying party shall, in lieu of indemnifying such indemnified party, contribute to the amount paid or payable by such indemnified party as a result of such loss, claim, damage or liability, or action in respect thereof, (i) in such proportion as shall be appropriate to reflect the relative benefits received by the Company on the one hand and the Underwriters on the other from the offering of the Stock or if the allocation provided by clause (i) above is not permitted by applicable law, in such proportion as is appropriate to reflect not only the relative benefits referred to in clause (i) above but also the relative fault of the Company on the one hand and the Underwriters on the other with respect to the statements or omissions which resulted in such loss, claim, damage or liability, or action in respect thereof, as well as any other relevant equitable considerations. The relative benefits received by the Company on the one hand and the Underwriters on the other with respect to such offering shall be deemed to be in the same proportion as the total net proceeds from the offering of the Stock purchased under this Agreement (before deducting expenses) received by the Company bear to the total underwriting discounts and commissions received by the Underwriters with respect to the Stock purchased under this Agreement, in each case as set forth in the table on the cover page of the Prospectus. The relative fault shall be determined by reference to, among other things, whether the untrue or alleged untrue statement of a material fact or the omission or alleged omission to state a material fact relates to information supplied by the Company on the one hand or the Underwriters on the other, the intent of the parties and their relative knowledge, access to information and opportunity to correct or prevent such untrue statement or omission; provided , that the parties hereto agree that the written information furnished to the Company through the Representatives by or on behalf of the Underwriters for use in any Preliminary Prospectus, either of the Registration Statements or the Prospectus consists solely of the Underwriter’s Information. The Company and the Underwriters agree that the QIU has not received and will not receive any additional benefits hereunder for serving as the QIU in connection with the offering of the Stock. The Company and the Underwriters agree that it would not be just and equitable if contributions pursuant to this Section 7(e) were to be determined by pro rata allocation (even if the Underwriters were treated as one

 

18


entity for such purpose) or by any other method of allocation which does not take into account the equitable considerations referred to herein. The amount paid or payable by an indemnified party as a result of the loss, claim, damage or liability, or action in respect thereof, referred to above in this Section 7(e) shall be deemed to include, for purposes of this Section 7(e), any legal or other expenses reasonably incurred by such indemnified party in connection with investigating or defending any such action or claim. Notwithstanding the provisions of this Section 7(e), no Underwriter shall be required to contribute any amount in excess of the amount by which the total price at which the Stock underwritten by it and distributed to the public were offered to the public less the amount of any damages which such Underwriter has otherwise paid or become liable to pay by reason of any untrue or alleged untrue statement or omission or alleged omission or in connection with its participation as a QIU. No person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution from any person who was not guilty of such fraudulent misrepresentation.

The Underwriters’ obligations to contribute as provided in this Section 7(e) are several in proportion to their respective underwriting obligations and not joint.

8. T ERMINATION . The obligations of the Underwriters hereunder may be terminated by Cowen, in its absolute discretion by notice given to and received by the Company prior to delivery of and payment for the Firm Stock if, prior to that time, any of the events described in Sections 6(k), 6(l) or 6(m) have occurred or if the Underwriters shall decline to purchase the Stock for any reason permitted under this Agreement.

9. R EIMBURSEMENT OF U NDERWRITERS ’ E XPENSES . If (a) this Agreement shall have been terminated pursuant to Section 8 or 10, (b) the Company shall fail to tender the Stock for delivery to the Underwriters for any reason not permitted under this Agreement, or (c) the Underwriters shall decline to purchase the Stock for any reason permitted under this Agreement, the Company shall reimburse the Underwriters for the reasonable fees and expenses of their counsel and for such other out-of-pocket expenses as shall have been reasonably incurred by them in connection with this Agreement and the proposed purchase of the Stock, and upon demand the Company shall pay the full amount thereof to Cowen. If this Agreement is terminated pursuant to Section 10 by reason of the default of one or more Underwriters, the Company shall not be obligated to reimburse any defaulting Underwriter on account of those expenses.

10. S UBSTITUTION OF U NDERWRITERS . If any Underwriter or Underwriters shall default in its or their obligations to purchase shares of Stock hereunder and the aggregate number of shares which such defaulting Underwriter or Underwriters agreed but failed to purchase does not exceed ten percent (10%) of the total number of shares underwritten, the other Underwriters shall be obligated severally, in proportion to their respective commitments hereunder, to purchase the shares which such defaulting Underwriter or Underwriters agreed but failed to purchase. If any Underwriter or Underwriters shall so default and the aggregate number of shares with respect to which such default or defaults occur is more than ten percent (10%) of the total number of shares underwritten and arrangements satisfactory to the Representatives and the Company for the purchase of such shares by other persons are not made within forty-eight (48) hours after such default, this Agreement shall terminate.

If the remaining Underwriters or substituted Underwriters are required hereby or agree to take up all or part of the shares of Stock of a defaulting Underwriter or Underwriters as provided in this Section 10, (i) the Company shall have the right to postpone the Closing Dates for a period of not more than five (5) full business days in order that the Company may effect whatever changes may thereby be made necessary in the Registration Statement or the Prospectus, or in any other documents or arrangements, and the Company agrees promptly to file any amendments to the Registration Statement or supplements to the Prospectus which may thereby be made necessary, and (ii) the respective numbers of shares to be purchased by the remaining Underwriters or substituted Underwriters shall be taken as the basis of their underwriting obligation for all purposes of this Agreement. Nothing herein contained shall relieve any defaulting Underwriter of its liability to the Company or the other Underwriters for damages occasioned by its default hereunder. Any termination of this Agreement pursuant to this Section 10 shall be without liability on the part of any non-defaulting Underwriter or the Company, except expenses to be paid or reimbursed pursuant to Sections 5 and 9 and except the provisions of Section 7 shall not terminate and shall remain in effect.

11. S UCCESSORS ; P ERSONS E NTITLED TO B ENEFIT OF A GREEMENT . This Agreement shall inure to the benefit of and be binding upon the several Underwriters, the Company and their respective successors. Nothing expressed or mentioned in this Agreement is intended or shall be construed to give any person other than the persons mentioned

 

19


in the preceding sentence any legal or equitable right, remedy or claim under or in respect of this Agreement, or any provisions herein contained, this Agreement and all conditions and provisions hereof being intended to be and being for the sole and exclusive benefit of such persons and for the benefit of no other person; except that the representations, warranties, covenants, agreements and indemnities of the Company contained in this Agreement shall also be for the benefit of the Underwriter Indemnified Parties and the QIU Indemnified Parties and the indemnities of the several Underwriters shall also be for the benefit of the Company Indemnified Parties. It is understood that the Underwriter’s responsibility to the Company is solely contractual in nature and the Underwriters do not owe the Company, or any other party, any fiduciary duty as a result of this Agreement.

12 . A BSENCE OF F IDUCIARY R ELATIONSHIP . The Company acknowledges and agrees that:

(a) each Underwriter’s responsibility to the Company is solely contractual in nature, the Representatives have been retained solely to act as underwriters in connection with the sale of the Stock and no fiduciary, advisory or agency relationship between the Company and the Representatives has been created in respect of any of the transactions contemplated by this Agreement, irrespective of whether any of the Representatives has advised or is advising the Company on other matters;

(b) the price of the Stock set forth in this Agreement was established by the Company following discussions and arms-length negotiations with the Representatives, and the Company is capable of evaluating and understanding, and understands and accepts, the terms, risks and conditions of the transactions contemplated by this Agreement;

(c) it has been advised that the Representatives and their affiliates are engaged in a broad range of transactions which may involve interests that differ from those of the Company and that the Representatives have no obligation to disclose such interests and transactions to the Company by virtue of any fiduciary, advisory or agency relationship; and

(d) it waives, to the fullest extent permitted by law, any claims it may have against the Representatives for breach of fiduciary duty or alleged breach of fiduciary duty and agrees that the Representatives shall have no liability (whether direct or indirect) to the Company in respect of such a fiduciary duty claim or to any person asserting a fiduciary duty claim on behalf of or in right of the Company, including stockholders, employees or creditors of the Company.

13 . S URVIVAL OF I NDEMNITIES , R EPRESENTATIONS , W ARRANTIES , ETC . The respective indemnities, covenants, agreements, representations, warranties and other statements of the Company and the several Underwriters, as set forth in this Agreement or made by them respectively, pursuant to this Agreement, shall remain in full force and effect, regardless of any investigation made by or on behalf of any Underwriter, the Company or any person controlling any of them and shall survive delivery of and payment for the Stock.

14. N OTICES . All statements, requests, notices and agreements hereunder shall be in writing, and:

(a) if to the Underwriters, shall be delivered or sent by mail, telex or facsimile transmission to Cowen and Company, LLC, Attention: General Counsel (Fax: 646-562-1861); and

(b) if to the Company shall be delivered or sent by mail, telex or facsimile transmission to Achillion Pharmaceuticals, Inc., Attention: President (Fax: 203-752-5350).

Any such statements, requests, notices or agreements shall take effect at the time of receipt thereof.

Notwithstanding the foregoing, any notice to an Underwriter pursuant to Section 7 shall be delivered or sent by mail, telex or facsimile transmission to such Underwriter at its address set forth in its acceptance telex to the Representatives, which address will be supplied to any other party hereto by the Representatives upon request.

15 . D EFINITION OF C ERTAIN T ERMS . For purposes of this Agreement, (a) “ business day ” means any day on which the New York Stock Exchange, Inc. is open for trading and (b) “ subsidiary ” has the meaning set forth in Rule 405 of the Rules and Regulations.

 

20


16 . G OVERNING L AW . This Agreement shall be governed by and construed in accordance with the laws of the State of New York, including without limitation Section 5-1401 of the New York General Obligations.

17 . U NDERWRITERS ’ I NFORMATION . The parties hereto acknowledge and agree that, for all purposes of this Agreement, the Underwriters’ Information consists solely of the following information in the Prospectus: (i) the last paragraph on the front cover page concerning the terms of the offering by the Underwriters; and (ii) the statements relating to the amount of selling concession and reallowance in the third paragraph under the heading “Underwriting.”

18 A UTHORITY OF THE R EPRESENTATIVES . In connection with this Agreement, you will act for and on behalf of the several Underwriters, and any action taken under this Agreement by the Representatives, will be binding on all the Underwriters.

19 . P ARTIAL U NENFORCEABILITY . The invalidity or unenforceability of any Section, paragraph or provision of this Agreement shall not affect the validity or enforceability of any other Section, paragraph or provision hereof. If any Section, paragraph or provision of this Agreement is for any reason determined to be invalid or unenforceable, there shall be deemed to be made such minor changes (and only such minor changes) as are necessary to make it valid and enforceable.

20 . G ENERAL . This Agreement constitutes the entire agreement of the parties to this Agreement and supersedes all prior written or oral and all contemporaneous oral agreements, understandings and negotiations with respect to the subject matter hereof. In this Agreement, the masculine, feminine and neuter genders and the singular and the plural include one another. The section headings in this Agreement are for the convenience of the parties only and will not affect the construction or interpretation of this Agreement. This Agreement may be amended or modified, and the observance of any term of this Agreement may be waived, only by a writing signed by the Company and the Representatives.

21 . C OUNTERPARTS . This Agreement may be signed in any number of counterparts, each of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument.

 

21


If the foregoing is in accordance with your understanding of the agreement between the Company and the several Underwriters, kindly indicate your acceptance in the space provided for that purpose below.

 

Very truly yours,

ACHILLION PHARMACEUTICALS, INC.

By:

    
 

Name:

 
 

Title:

 

Accepted as of

the date first above written:

COWEN AND COMPANY, LLC

CIBC WORLD MARKETS CORP.

JMP SECURITIES LLC

Acting on their own behalf

and as Representatives of several

Underwriters referred to in the

foregoing Agreement.

 

By:

 

COWEN AND COMPANY, LLC

By:

    
 

Name:

 

William B. Buchanan, Jr.

 

Title:

 

Head of Equity Capital Markets

 

22


SCHEDULE A

 

Name

   Number
of Firm
Shares
to be
Purchased
   Number of
Optional
Shares
to be
Purchased

Cowen and Company, LLC

     

CIBC World Markets Corp.

     

JMP Securities LLC

     

Total

     
         

 

23


SCHEDULE B

Pricing Information

1. The number of shares of Stock to be sold is                     shares, including                      shares of Optional Stock.

2. The initial public offering price for the Stock is $             per share.

3. The underwriting discounts and commissions for the Stock is $             per share.

 

24


SCHEDULE C

Issuer General Free Writing Prospectuses

 

25


SCHEDULE D

Advent Health Care & Life Sciences II Limited Partnership and affiliated funds

Atlas Venture Fund V, L.P. and affiliated funds

Bear Stearns Health Innoventures, L.P. and affiliated funds

Connecticut Innovations, Incorporated and affiliated entities

Gilead Sciences, Inc.

Schroder Ventures International Life Sciences Fund II LP and affiliated funds

SGC Partners I LLC and affiliated funds

Michael D. Kishbauch

Milind S. Deshpande

Kevin L. Eastwood

Mary Kay Fenton

John C. Pottage, Jr., M.D.

Gautam Shah, Ph.D.

Jason Fisherman, M.D.

Jean-Francois Formela, M.D.

James Garvey

Michael Grey

Stefan Ryser, Ph.D.

David I. Scheer

Christopher A. White

 

26


Exhibit I

[Form of Lock-Up Agreement]

                     , 2006

COWEN AND COMPANY, LLC

CIBC WORLD MARKETS CORP.

JMP SECURITIES LLC

As representatives of the several Underwriters

c/o Cowen and Company, LLC

1221 Avenue of the Americas

New York, New York 10020

 

Re: Achillion Pharmaceuticals, Inc. - Public Offering of Shares of Common Stock

Dear Sirs:

In order to induce Cowen and Company, LLC (“Cowen”), CIBC World Markets Corp. and JMP Securities LLC (together with Cowen, the “Representatives”), to enter into a certain underwriting agreement with Achillion Pharmaceuticals, Inc., a Delaware corporation (the “Company”), with respect to the public offering of shares of the Company’s Common Stock, par value $0.001 per share (“Common Stock”), the undersigned hereby agrees that for a period of 180 days following the date of the final prospectus filed by the Company with the Securities and Exchange Commission in connection with such public offering, the undersigned will not, without the prior written consent of Cowen, directly or indirectly, (i) offer, sell, assign, transfer, pledge, contract to sell, or otherwise dispose of, any shares of Common Stock (including, without limitation, Common Stock which may be deemed to be beneficially owned by the undersigned in accordance with the rules and regulations promulgated under the Securities Act of 1933, as the same may be amended or supplemented from time to time (such shares, the “Beneficially Owned Shares”)) or securities convertible into or exercisable or exchangeable in Common Stock, (ii) enter into any swap, hedge or similar agreement or arrangement that transfers in whole or in part, the economic risk of ownership of the Beneficially Owned Shares or securities convertible into or exercisable or exchangeable in Common Stock or (iii) engage in any short selling of the Common Stock.

Notwithstanding the foregoing, the undersigned may transfer shares (i) as a bona fide gift or gifts, (ii) to any trust for the direct or indirect benefit of the undersigned or the immediate family of the undersigned, (iii) by will or intestate succession, (iv) to any affiliate (as defined in Regulation C under the Securities Act of 1933, as amended) of the undersigned, (v) if the undersigned is a corporation or similar entity, to any wholly-owned subsidiaries of such corporation or similar entity, (vi) if the undersigned is a partnership, limited liability company or similar entity, to any partners or members of such partnership, limited liability company or similar entity or (vii) with the prior written consent of Cowen on behalf of the underwriters; provided, that (1) Cowen receives a signed lock-up agreement for the balance of the lock-up period from each donee, trustee, distributee, or transferee as the case may be, (2) any such transfer shall not involve a disposition for value and (3) such transfers are not required to be reported in any public report or filing with the Securities and Exchange Commission, or otherwise including, without limitation, the filing of a Schedule 13D, a Schedule 13G and/or a Form 4. For purposes of this Agreement, “immediate family” shall mean any relationship by blood, marriage or adoption, not more remote than first cousin.

If (i) the Company issues an earnings release or material news or a material event relating to the Company occurs during the last 17 days of the lock-up period, or (ii) prior to the expiration of the lock-up period, the Company announces that it will release earnings results during the 16-day period beginning on the last day of the lock-up period, the restrictions imposed by this Agreement shall continue to apply until the expiration of the 18-day period beginning on the issuance of the earnings release or the occurrence of the material news or material event.

 

27


In addition, the undersigned hereby waives, from the date hereof until the expiration of the 180-day period following the date of the Company’s final Prospectus, any and all rights, if any, to request or demand registration pursuant to the Securities Act of any shares of Common Stock that are registered in the name of the undersigned or that are Beneficially Owned Shares. In order to enable the aforesaid covenants to be enforced, the undersigned hereby consents to the placing of legends and/or stop-transfer orders with the transfer agent of the Common Stock with respect to any shares of Common Stock or Beneficially Owned Shares.

This agreement shall automatically terminate on May 31, 2007 in the event that the registration statement has not been declared effective by that date.

 

  

Company Name (if applicable)

Address:

    
    
    

 

28

Exhibit 3.3

CERTIFICATE OF AMENDMENT

OF

AMENDED AND RESTATED

CERTIFICATE OF INCORPORATION

OF

ACHILLION PHARMACEUTICALS, INC.

Pursuant to Section 242 of the

General Corporation Law of the State of Delaware

Achillion Pharmaceuticals, Inc. (hereinafter called the “Corporation”), organized and existing under and by virtue of the General Corporation Laws of the State of Delaware, does hereby certify as follows:

The Board of Directors of the Corporation duly adopted resolutions, pursuant to Sections 141(f) and 242 of the General Corporation Law of the State of Delaware, setting forth amendments to the Amended and Restated Certificate of Incorporation, as amended, of the Corporation and declaring said amendments to be advisable. The stockholders of the Corporation duly adopted said amendments by written consent in accordance with Sections 228 and 242 of the General Corporation Law of the State of Delaware. The resolution setting forth the amendments is as follows:

RESOLVED: That the Amended and Restated Certificate of Incorporation of the Corporation, as amended (the “Certificate of Incorporation”), be further amended as follows:

 

  (1) Paragraph A of Article IV of the Amended and Restated Certificate of Incorporation of the Corporation, as amended, is hereby deleted in its entirety and the following is inserted in lieu thereof:

“A. Effective upon the filing of this Certificate of Amendment of Certificate of Incorporation (the “Effective Time”), a one-for-eight reverse stock split of the Corporation’s common stock shall become effective, pursuant to which each eight shares of Common Stock outstanding and held of record by each stockholder of the Corporation (including treasury shares) immediately prior to the Effective Time shall be reclassified and combined into one share of Common Stock automatically and without any action by the holder thereof upon the Effective Time and shall represent one share of Common Stock from and after the Effective Time. No fractional shares of Common Stock shall be issued as a result of such reclassification and combination. In lieu of any fractional shares to which the stockholder would otherwise be entitled, the Corporation shall pay cash equal to such fraction multiplied by the then fair market value of the Common Stock as determined by the Board of Directors of the Corporation.

The total number of shares of all classes of stock which the Corporation shall have authority to issue is 169,527,905 shares, consisting of:


(i) 74,527,905 shares of Preferred Stock, par value $.01 per share (the “Preferred Stock”), of which:

(A) 250,000 shares shall be designated “Series A Convertible Preferred Stock” (the “Series A Stock”);

(B) 18,816,666 shares shall be designated “Series B Convertible Preferred Stock” (the “Series B Stock”);

(C) 27,185,802 shares shall be designated “Series C Convertible Preferred Stock” (the “Series C Stock”);

(D) 2,525,437 shares shall be designated “Series C-1 Convertible Preferred Stock” (the “Series C-1 Stock”); and

(E) 25,750,000 shares shall be designated “Series C-2 Convertible Preferred Stock” (the “Series C-2 Stock”); and

(ii) 95,000 shares of Common Stock, par value $.001 per share (the “Common Stock”).”

 

  (2) Subsection 4(a) of Section C of Article IV of the Amended and Restated Certificate of Incorporation of the Corporation, as amended, is hereby deleted in its entirety and the following is hereby inserted in lieu thereof:

“(a) Right to Convert . Subject to the terms and conditions of this Section IV.C.4, the holder of any share or shares of Series A, Series B, Series C, Series C-1 or Series C-2 Preferred Stock shall have the right, at its option at any time, to convert any such shares of such series of Preferred Stock (except that upon any liquidation of the Corporation the right of conversion shall terminate at the close of business on the business day fixed for payment of the amount distributable on such series of Preferred Stock) into such number of fully paid and nonassessable shares of Common Stock as is obtained by dividing the Original Cost in effect for such share of such series of Preferred Stock by the Conversion Price (as hereinafter defined) applicable to such share of such series of Preferred Stock, determined as hereafter provided, as last adjusted and in effect on the date the certificate is surrendered for conversion. The “Conversion Price” for the Series A Preferred Stock is currently $8.00. The “Conversion Price” for the Series B Preferred Stock is currently $12.00. The “Conversion Price” for the Series C Preferred Stock is currently $12.117784. The “Conversion Price” for the Series C-1 Preferred Stock is currently 14.541368. The “Conversion Price” for the Series C-2 Preferred Stock is currently $12.00. The Series A, Series B, Series C, Series C-1 and Series C-2 Conversion Prices shall be subject to adjustment as hereinafter provided. Such rights of conversion shall be exercised by the holder thereof by giving written notice that the holder elects to convert a stated number of shares of such series of Preferred Stock into Common Stock and by surrender of a certificate or certificates (or an affidavit of lost stock certificate with respect thereto) for the shares so to be converted to the Corporation at its principal office

 

- 2 -


(or such other office or agency of the Corporation as the Corporation may designate by notice in writing to the holders of the Preferred Stock) at any time during its usual business hours on the date set forth in such notice, together with a statement of the name or names (with address) in which the certificate or certificates for shares of Common Stock shall be issued.”

 

  (3) Subsection 4(e) of Section C of Article IV of the Amended and Restated Certificate of Incorporation of the Corporation, as amended, is hereby deleted in its entirety and the following is hereby inserted in lieu thereof:

“(e) Additional Stock; Certain Issues Excepted . “Additional Stock” shall mean any shares of Common Stock issued (or deemed to have been issued pursuant to Subsection IV.C.4(d)(iv)) by the Corporation other than the issuance of:

(i) shares issued or issuable to directors, officers, employees or consultants of the Corporation in connection with their service as directors of the Corporation, their employment by the Corporation or their retention as consultants by the Corporation, pursuant to subscriptions, warrants, options, convertible securities or other rights outstanding as of the date of the filing of this Certificate of Amendment of Amended and Restated Certificate of Incorporation to acquire Common Stock (the “Reserved Employee Shares”);

(ii) securities issued solely in consideration for the bona fide acquisition (whether by merger or otherwise) by the Corporation or any of its subsidiaries of all or substantially all of the stock or assets of any other entity;

(iii) securities issued in connection with bank loans or equipment financings approved by the Board;

(iv) shares of Series C Preferred Stock, shares of Series C-2 Preferred Stock and shares of Common Stock upon exercise of warrants outstanding as of the date of the filing of this Certificate of Amendment of Amended and Restated Certificate of Incorporation;

(v) Convertible Securities issued as a dividend or distribution on Series B Preferred Stock, Series C Preferred Stock, Series C-1 Preferred Stock and/or Series C-2 Preferred Stock;

(vi) securities issued pursuant to a firm commitment underwritten public offering; and

(vii) shares of Common Stock issued upon conversion of Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series C-1 Preferred Stock and/or Series C-2 Preferred Stock.”

 

- 3 -


  (4) Subsection 4(n) of Section C of Article IV of the Amended and Restated Certificate of Incorporation of the Corporation, as amended, is hereby deleted in its entirety and the following is hereby inserted in lieu thereof:

“(n) Mandatory Conversion . Upon either (a) the closing of the sale of shares of Common Stock to the public resulting in aggregate gross proceeds of not less than $35,000,000 (a “Qualified Public Offering”) or (b) the date and time, or the occurrence of an event specified by the vote of holders of at least sixty-six and two-thirds percent (66-2/3%) of the Series A, Series A-1, Series B, Series C, Series C-1 and Series C-2 Preferred Stock, voting together as a single class and not as separate series (the time of such closing or the date and time specified or the time of the event specified in such vote or written consent is referred to herein as the “Mandatory Conversion Time”), then (i) all outstanding shares of Series A, Series B, Series C, Series C-1 and Series C-2 Preferred Stock shall automatically convert to shares of Common Stock on the basis set forth in this Section C.4 and (ii) such shares may not be reissued by the Corporation. Holders of shares of Preferred Stock so converted may deliver to the Corporation at its principal office (or such other office or agency of the Corporation as the Corporation may designate by notice in writing to such holders) during its usual business hours, the certificate or certificates for the shares so converted. As promptly as practicable thereafter, the Corporation shall issue and deliver to such holder a certificate or certificates for the number of whole shares of Common Stock to which such holder is entitled, together with any dividends and payment in lieu of fractional shares to which such holder may be entitled pursuant to Subsection C.4(c) of Article IV. Until such time as a holder of shares of Preferred Stock shall surrender his or its certificates therefor as provided above, such certificates shall be deemed to represent the shares of Common Stock to which such holder shall be entitled upon the surrender thereof.

If so required by the Corporation, certificates surrendered for conversion shall be endorsed or accompanied by a written instrument or instruments of transfer, in form satisfactory to the Corporation, duly executed by the registered holder or by his, her or its attorney duly authorized in writing. All shares of Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series C-1 Preferred Stock and Series C-2 Preferred Stock shall, from and after the Mandatory Conversion Time, no longer be deemed to be outstanding and, notwithstanding the failure of the holder or holders thereof to surrender the certificates for such shares on or prior to such time, all rights with respect to such shares shall immediately cease and terminate at the Mandatory Conversion Time, except only the right of the holders thereof to receive shares of Common Stock in exchange therefor and to receive payment of any dividends declared or accrued but unpaid thereon. All certificates evidencing shares of Preferred Stock which are required to be surrendered for conversion in accordance with the provisions of this Subsection 4(n) shall be, from and after the date such certificates are so required to be surrendered, deemed to have been retired and canceled and the shares of Preferred Stock presented thereby converted into Common Stock for all purposes, notwithstanding the failure of the holder or holders thereof to surrender such

 

- 4 -


certificates on or prior to such date. Upon the Mandatory Conversion Time, the number of authorized shares of Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series C-1 Preferred Stock and Series C-2 Preferred Stock shall be automatically reduced by the number of shares of Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series C-1 Preferred Stock and Series C-2 Preferred Stock that had been designated as Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series C-1 Preferred Stock and Series C-2 Preferred Stock, and all references to the Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series C-1 Preferred Stock and Series C-2 Preferred Stock in this Certificate of Incorporation shall be deleted and of no further force and effect.”

 

  (5) Article X of the Amended and Restated Certificate of Incorporation of the Corporation, as amended, is hereby deleted in its entirety and the following is inserted in lieu thereof:

“ARTICLE X

The Corporation shall provide indemnification as follows:

1. Actions, Suits and Proceedings Other than by or in the Right of the Corporation . The Corporation shall indemnify each person who was or is a party or threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of the Corporation) by reason of the fact that he or she is or was, or has agreed to become, a director or officer of the Corporation, or is or was serving, or has agreed to serve, at the request of the Corporation, as a director, officer, partner, employee or trustee of, or in a similar capacity with, another corporation, partnership, joint venture, trust or other enterprise (including any employee benefit plan) (all such persons being referred to hereafter as an “Indemnitee”), or by reason of any action alleged to have been taken or omitted in such capacity, against all expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by or on behalf of the Indemnitee in connection with such action, suit or proceeding and any appeal therefrom, if the Indemnitee acted in good faith and in a manner which the Indemnitee reasonably believed to be in, or not opposed to, the best interests of the Corporation, and, with respect to any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful. The termination of any action, suit or proceeding by judgment, order, settlement, conviction or upon a plea of nolo contendere or its equivalent, shall not, of itself, create a presumption that the Indemnitee did not act in good faith and in a manner which the Indemnitee reasonably believed to be in, or not opposed to, the best interests of the Corporation, and, with respect to any criminal action or proceeding, had reasonable cause to believe that his or her conduct was unlawful.

2. Actions or Suits by or in the Right of the Corporation . The Corporation shall indemnify any Indemnitee who was or is a party to or

 

- 5 -


threatened to be made a party to any threatened, pending or completed action or suit by or in the right of the Corporation to procure a judgment in its favor by reason of the fact that the Indemnitee is or was, or has agreed to become, a director or officer of the Corporation, or is or was serving, or has agreed to serve, at the request of the Corporation, as a director, officer, partner, employee or trustee of, or in a similar capacity with, another corporation, partnership, joint venture, trust or other enterprise (including any employee benefit plan), or by reason of any action alleged to have been taken or omitted in such capacity, against all expenses (including attorneys’ fees) and, to the extent permitted by law, amounts paid in settlement actually and reasonably incurred by or on behalf of the Indemnitee in connection with such action, suit or proceeding and any appeal therefrom, if the Indemnitee acted in good faith and in a manner which the Indemnitee reasonably believed to be in, or not opposed to, the best interests of the Corporation, except that no indemnification shall be made under this Section 2 in respect of any claim, issue or matter as to which the Indemnitee shall have been adjudged to be liable to the Corporation, unless, and only to the extent, that the Court of Chancery of Delaware shall determine upon application that, despite the adjudication of such liability but in view of all the circumstances of the case, the Indemnitee is fairly and reasonably entitled to indemnity for such expenses (including attorneys’ fees) which the Court of Chancery of Delaware shall deem proper.

3. Indemnification for Expenses of Successful Party . Notwithstanding any other provisions of this Article, to the extent that an Indemnitee has been successful, on the merits or otherwise, in defense of any action, suit or proceeding referred to in Sections 1 and 2 of this Article X, or in defense of any claim, issue or matter therein, or on appeal from any such action, suit or proceeding, the Indemnitee shall be indemnified against all expenses (including attorneys’ fees) actually and reasonably incurred by or on behalf of the Indemnitee in connection therewith. Without limiting the foregoing, if any action, suit or proceeding is disposed of, on the merits or otherwise (including a disposition without prejudice), without (i) the disposition being adverse to the Indemnitee, (ii) an adjudication that the Indemnitee was liable to the Corporation, (iii) a plea of guilty or nolo contendere by the Indemnitee, (iv) an adjudication that the Indemnitee did not act in good faith and in a manner he reasonably believed to be in or not opposed to the best interests of the Corporation, and (v) with respect to any criminal proceeding, an adjudication that the Indemnitee had reasonable cause to believe his conduct was unlawful, the Indemnitee shall be considered for the purposes hereof to have been wholly successful with respect thereto.

4. Notification and Defense of Claim . As a condition precedent to an Indemnitee’s right to be indemnified, such Indemnitee must notify the Corporation in writing as soon as practicable of any action, suit, proceeding or investigation involving such Indemnitee for which indemnity will or could be sought. With respect to any action, suit, proceeding or investigation of which the Corporation is so notified, the Corporation will be entitled to participate therein at

 

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its own expense and/or to assume the defense thereof at its own expense, with legal counsel reasonably acceptable to the Indemnitee. After notice from the Corporation to the Indemnitee of its election so to assume such defense, the Corporation shall not be liable to the Indemnitee for any legal or other expenses subsequently incurred by the Indemnitee in connection with such action, suit, proceeding or investigation, other than as provided below in this Section 4. The Indemnitee shall have the right to employ his or her own counsel in connection with such action, suit, proceeding or investigation, but the fees and expenses of such counsel incurred after notice from the Corporation of its assumption of the defense thereof shall be at the expense of the Indemnitee unless (i) the employment of counsel by the Indemnitee has been authorized by the Corporation, (ii) counsel to the Indemnitee shall have reasonably concluded that there may be a conflict of interest or position on any significant issue between the Corporation and the Indemnitee in the conduct of the defense of such action, suit, proceeding or investigation or (iii) the Corporation shall not in fact have employed counsel to assume the defense of such action, suit, proceeding or investigation, in each of which cases the fees and expenses of counsel for the Indemnitee shall be at the expense of the Corporation, except as otherwise expressly provided by this Article. The Corporation shall not be entitled, without the consent of the Indemnitee, to assume the defense of any claim brought by or in the right of the Corporation or as to which counsel for the Indemnitee shall have reasonably made the conclusion provided for in clause (ii) above. The Corporation shall not be required to indemnify the Indemnitee under this Article X for any amounts paid in settlement of any action, suit, proceeding or investigation effected without its written consent. The Corporation shall not settle any action, suit, proceeding or investigation in any manner which would impose any penalty or limitation on the Indemnitee without the Indemnitee’s written consent. Neither the Corporation nor the Indemnitee will unreasonably withhold or delay its consent to any proposed settlement.

5. Advance of Expenses . Subject to the provisions of Section 6 of this Article X, in the event of any action, suit, proceeding or investigation of which the Corporation receives notice under this Article, any expenses (including attorneys’ fees) incurred by or on behalf of the Indemnitee in defending an action, suit, proceeding or investigation or any appeal therefrom shall be paid by the Corporation in advance of the final disposition of such matter; provided, however, that the payment of such expenses incurred by or on behalf of the Indemnitee in advance of the final disposition of such matter shall be made only upon receipt of an undertaking by or on behalf of the Indemnitee to repay all amounts so advanced in the event that it shall ultimately be determined that the Indemnitee is not entitled to be indemnified by the Corporation as authorized in this Article; and further provided that no such advancement of expenses shall be made under this Article X if it is determined (in the manner described in Section 6) that (i) the Indemnitee did not act in good faith and in a manner he reasonably believed to be in, or not opposed to, the best interests of the Corporation, or (ii) with respect to any criminal action or proceeding, the Indemnitee had reasonable cause to believe his conduct was unlawful. Such undertaking shall be accepted without reference to the financial ability of the Indemnitee to make such repayment.

 

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6. Procedure for Indemnification . In order to obtain indemnification or advancement of expenses pursuant to Section 1, 2, 3 or 5 of this Article X, an Indemnitee shall submit to the Corporation a written request. Any such advancement of expenses shall be made promptly, and in any event within 60 days after receipt by the Corporation of the written request of the Indemnitee, unless (i) the Corporation has assumed the defense pursuant to Section 4 of this Article X (and none of the circumstances described in Section 4 of this Article X that would nonetheless entitle the Indemnitee to indemnification for the fees and expenses of separate counsel have occurred) or (ii) the Corporation determines within such 60 day period that the Indemnitee did not meet the applicable standard of conduct set forth in Section 1, 2 or 5 of this Article X, as the case may be. Any such indemnification, unless ordered by a court, shall be made with respect to requests under Section 1 or 2 only as authorized in the specific case upon a determination by the Corporation that the indemnification of the Indemnitee is proper because the Indemnitee has met the applicable standard of conduct set forth in Section 1 or 2, as the case may be. Such determination shall be made in each instance (a) by a majority vote of the directors of the Corporation consisting of persons who are not at that time parties to the action, suit or proceeding in question (“disinterested directors”), whether or not a quorum, (b) by a committee of disinterested directors designated by majority vote of disinterested directors, whether or not a quorum, (c) if there are no disinterested directors, or if the disinterested directors so direct, by independent legal counsel (who may, to the extent permitted by law, be regular legal counsel to the Corporation) in a written opinion, or (d) by the stockholders of the Corporation.

7. Remedies . The right to indemnification or advancement of expenses as granted by this Article shall be enforceable by the Indemnitee in any court of competent jurisdiction. Neither the failure of the Corporation to have made a determination prior to the commencement of such action that indemnification is proper in the circumstances because the Indemnitee has met the applicable standard of conduct, nor an actual determination by the Corporation pursuant to Section 6 of this Article X that the Indemnitee has not met such applicable standard of conduct, shall be a defense to the action or create a presumption that the Indemnitee has not met the applicable standard of conduct. The Indemnitee’s expenses (including attorneys’ fees) reasonably incurred in connection with successfully establishing the Indemnitee’s right to indemnification, in whole or in part, in any such proceeding shall also be indemnified by the Corporation.

8. Limitations . Notwithstanding anything to the contrary in this Article, except as set forth in Section 7 of this Article X, the Corporation shall not indemnify an Indemnitee pursuant to this Article X in connection with a proceeding (or part thereof) initiated by such Indemnitee unless the initiation thereof was approved by the Board of Directors of the Corporation.

 

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Notwithstanding anything to the contrary in this Article, the Corporation shall not indemnify an Indemnitee to the extent such Indemnitee is reimbursed from the proceeds of insurance, and in the event the Corporation makes any indemnification payments to an Indemnitee and such Indemnitee is subsequently reimbursed from the proceeds of insurance, such Indemnitee shall promptly refund indemnification payments to the Corporation to the extent of such insurance reimbursement.

9. Subsequent Amendment . No amendment, termination or repeal of this Article or of the relevant provisions of the General Corporation Law of Delaware or any other applicable laws shall affect or diminish in any way the rights of any Indemnitee to indemnification under the provisions hereof with respect to any action, suit, proceeding or investigation arising out of or relating to any actions, transactions or facts occurring prior to the final adoption of such amendment, termination or repeal.

10. Other Rights . The indemnification and advancement of expenses provided by this Article shall not be deemed exclusive of any other rights to which an Indemnitee seeking indemnification or advancement of expenses may be entitled under any law (common or statutory), agreement or vote of stockholders or disinterested directors or otherwise, both as to action in the Indemnitee’s official capacity and as to action in any other capacity while holding office for the Corporation, and shall continue as to an Indemnitee who has ceased to be a director or officer, and shall inure to the benefit of the estate, heirs, executors and administrators of Indemnitee. Nothing contained in this Article shall be deemed to prohibit, and the Corporation is specifically authorized to enter into, agreements with officers and directors providing indemnification rights and procedures different from those set forth in this Article. In addition, the Corporation may, to the extent authorized from time to time by its Board of Directors, grant indemnification rights to other employees or agents of the Corporation or other persons serving the Corporation and such rights may be equivalent to, or greater or less than, those set forth in this Article.

11. Partial Indemnification . If an Indemnitee is entitled under any provision of this Article to indemnification by the Corporation for some or a portion of the expenses (including attorneys’ fees), judgments, fines or amounts paid in settlement actually and reasonably incurred by or on behalf of the Indemnitee in connection with any action, suit, proceeding or investigation and any appeal therefrom but not, however, for the total amount thereof, the Corporation shall nevertheless indemnify the Indemnitee for the portion of such expenses (including attorneys’ fees), judgments, fines or amounts paid in settlement to which the Indemnitee is entitled.

12. Insurance . The Corporation may purchase and maintain insurance, at its expense, to protect itself and any director, officer, employee or agent of the Corporation or another corporation, partnership, joint venture, trust or other enterprise (including any employee benefit plan) against any expense, liability or

 

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loss incurred by him in any such capacity, or arising out of his status as such, whether or not the Corporation would have the power to indemnify such person against such expense, liability or loss under the General Corporation Law of Delaware.

13. Savings Clause . If this Article or any portion hereof shall be invalidated on any ground by any court of competent jurisdiction, then the Corporation shall nevertheless indemnify each Indemnitee as to any expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement in connection with any action, suit, proceeding or investigation, whether civil, criminal or administrative, including an action by or in the right of the Corporation, to the fullest extent permitted by any applicable portion of this Article that shall not have been invalidated and to the fullest extent permitted by applicable law.

14. Definitions . Terms used herein and defined in Section 145(h) and Section 145(i) of the General Corporation Law of Delaware shall have the respective meanings assigned to such terms in such Section 145(h) and Section 145(i).”

 

  (6) Article XI of the Amended and Restated Certificate of Incorporation of the Corporation, as amended, is hereby deleted in its entirety and the following is hereby inserted in lieu thereof:

“ARTICLE XI

A. Except to the extent that the General Corporation Law of Delaware prohibits the elimination or limitation of liability of directors for breaches of fiduciary duty, no director of the Corporation shall be personally liable to the Corporation or its stockholders for monetary damages for any breach of fiduciary duty as a director, notwithstanding any provision of law imposing such liability. No amendment to or appeal of this provision shall apply to or have any effect on the liability or alleged liability of any director of the Corporation for or with respect to any acts or omissions of such director occurring prior to such amendment or repeal.”

 

  (7) The following new Article XIII is hereby added to the Amended and Restated Certificate of Incorporation of the Corporation, as amended:

“ARTICLE XII

A. Upon the closing of the sale of shares of Common Stock in a firm commitment underwriting meeting the requirements of Subsection C.4(n) of Article IV, stockholders of the Corporation may not take any action by written consent in lieu of a meeting. Notwithstanding any other provisions of law, this Certificate of Incorporation or the Bylaws of the Corporation, and notwithstanding the fact that a lesser percentage may be specified by law, the affirmative vote of the holders of at least seventy-five percent (75%) of the votes which all the stockholders would be entitled to cast in any annual election of directors or class of directors shall be required to amend or repeal, or to adopt any provision inconsistent with, this paragraph A of Article XII.

B. Special meetings of stockholders for any purpose or purposes may be called at any time by the Board of Directors, the Chairman of the Board or the President, but such special meetings may not be called by any other person or persons. Business transacted at any special meeting of stockholders shall be limited to matters relating to the purpose or purposes stated in the notice of meeting. Notwithstanding any other provision of law, this Certificate of Incorporation or the Bylaws of the Corporation, and notwithstanding the fact that a lesser percentage may be specified by law, the affirmative vote of the holders of at least seventy-five percent (75%) of the votes which all the stockholders would be entitled to cast in any annual election of directors or class of directors shall be required to amend or repeal, or to adopt any provision inconsistent with, this paragraph B Article XII.”

 

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IN WITNESS WHEREOF, the Corporation has caused this Certificate of Amendment to be signed by its President and Chief Executive Officer on this      day of September, 2006.

 

ACHILLION PHARMACEUTICALS, INC.
By:  

 

  Michael D. Kishbauch
  President and Chief Executive Officer

 

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Exhibit 3.4

RESTATED CERTIFICATE OF INCORPORATION

OF

ACHILLION PHARMACEUTICALS, INC.

(originally incorporated on August 5, 1998)

FIRST: The name of the Corporation is Achillion Pharmaceuticals, Inc.

SECOND: The address of the Corporation’s registered office in the State of Delaware is Corporation Trust Center, 1209 Orange Street, in the City of Wilmington, County of New Castle. The name of its registered agent at such address is The Corporation Trust Company.

THIRD: The nature of the business or purposes to be conducted or promoted by the Corporation is to engage in any lawful act or activity for which corporations may be organized under the General Corporation Law of Delaware.

FOURTH: The total number of shares of all classes of stock which the Corporation shall have authority to issue is 105,000,000 shares, consisting of (i) 100,000,000 shares of Common Stock, $.001 par value per share (“Common Stock”), and (ii) 5,000,000 shares of Preferred Stock, $.01 par value per share (“Preferred Stock”).

The following is a statement of the designations and the powers, privileges and rights, and the qualifications, limitations or restrictions thereof in respect of each class of capital stock of the Corporation.

A COMMON STOCK .

1. General . The voting, dividend and liquidation rights of the holders of the Common Stock are subject to and qualified by the rights of the holders of the Preferred Stock of any series as may be designated by the Board of Directors upon any issuance of the Preferred Stock of any series.

2. Voting . The holders of the Common Stock shall have voting rights at all meetings of stockholders, each such holder being entitled to one vote for each share thereof held by such holder; provided , however , that, except as otherwise required by law, holders of Common Stock shall not be entitled to vote on any amendment to this Certificate of Incorporation (which, as used herein, shall mean the certificate of incorporation of the Corporation, as amended from time to time, including the terms of any certificate of designations of any series of Preferred Stock) that relates solely to the terms of one or more outstanding series of Preferred Stock if the holders of such affected series are entitled, either separately or together as a class with the holders of one or more other such series, to vote thereon pursuant to this Certificate of Incorporation. There shall be no cumulative voting.

The number of authorized shares of Common Stock may be increased or decreased (but not below the number of shares thereof then outstanding) by the affirmative vote of the holders of a majority of the stock of the Corporation entitled to vote, irrespective of the provisions of Section 242(b)(2) of the General Corporation Law of Delaware.


3. Dividends . Dividends may be declared and paid on the Common Stock from funds lawfully available therefor as and when determined by the Board of Directors and subject to any preferential dividend or other rights of any then outstanding Preferred Stock.

4. Liquidation . Upon the dissolution or liquidation of the Corporation, whether voluntary or involuntary, holders of Common Stock will be entitled to receive all assets of the Corporation available for distribution to its stockholders, subject to any preferential or other rights of any then outstanding Preferred Stock.

B PREFERRED STOCK .

Preferred Stock may be issued from time to time in one or more series, each of such series to have such terms as stated or expressed herein and in the resolution or resolutions providing for the issue of such series adopted by the Board of Directors of the Corporation as hereinafter provided. Any shares of Preferred Stock which may be redeemed, purchased or acquired by the Corporation may be reissued except as otherwise provided by law.

Authority is hereby expressly granted to the Board of Directors from time to time to issue the Preferred Stock in one or more series, and in connection with the creation of any such series, by resolution or resolutions providing for the issuance of the shares thereof, to determine and fix the number of shares of such series and such voting powers, full or limited, or no voting powers, and such designations, preferences and relative participating, optional or other special rights, and qualifications, limitations or restrictions thereof, including without limitation thereof, dividend rights, conversion rights, redemption privileges and liquidation preferences, as shall be stated and expressed in such resolutions, all to the full extent now or hereafter permitted by the General Corporation Law of Delaware. Without limiting the generality of the foregoing, the resolutions providing for issuance of any series of Preferred Stock may provide that such series shall be superior or rank equally or be junior to the Preferred Stock of any other series to the extent permitted by law.

The number of authorized shares of Preferred Stock may be increased or decreased (but not below the number of shares then outstanding) by the affirmative vote of the holders of a majority of the stock of the Corporation entitled to vote, irrespective of the provisions of Section 242(b)(2) of the General Corporation Law of Delaware.

FIFTH: Except as otherwise provided herein, the Corporation reserves the right to amend, alter, change or repeal any provision contained in this Certificate of Incorporation, in the manner now or hereafter prescribed by statute and this Certificate of Incorporation, and all rights conferred upon stockholders herein are granted subject to this reservation.

SIXTH: In furtherance and not in limitation of the powers conferred upon it by the laws of the State of Delaware, and subject to the terms of any series of Preferred Stock, the Board of Directors shall have the power to adopt, amend, alter or repeal the Corporation’s By-laws. The affirmative vote of a majority of the directors present at any regular or special meeting of the Board of Directors at which a quorum is present shall be required to adopt, amend, alter or repeal

 

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the Corporation’s By-laws. The Corporation’s By-laws also may be adopted, amended, altered or repealed by the affirmative vote of the holders of at least seventy-five percent (75%) of the votes which all the stockholders would be entitled to cast in any annual election of directors or class of directors, in addition to any other vote required by this Certificate of Incorporation. Notwithstanding any other provisions of law, this Certificate of Incorporation or the By-Laws of the Corporation, and notwithstanding the fact that a lesser percentage may be specified by law, the affirmative vote of the holders of at least seventy-five percent (75%) of the votes which all the stockholders would be entitled to cast in any annual election of directors or class of directors shall be required to amend or repeal, or to adopt any provision inconsistent with, this Article SIXTH.

SEVENTH: Except to the extent that the General Corporation Law of Delaware prohibits the elimination or limitation of liability of directors for breaches of fiduciary duty, no director of the Corporation shall be personally liable to the Corporation or its stockholders for monetary damages for any breach of fiduciary duty as a director, notwithstanding any provision of law imposing such liability. No amendment to or repeal of this provision shall apply to or have any effect on the liability or alleged liability of any director of the Corporation for or with respect to any acts or omissions of such director occurring prior to such amendment or repeal.

EIGHTH: The Corporation shall provide indemnification as follows:

1. Actions, Suits and Proceedings Other than by or in the Right of the Corporation . The Corporation shall indemnify each person who was or is a party or threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of the Corporation) by reason of the fact that he or she is or was, or has agreed to become, a director or officer of the Corporation, or is or was serving, or has agreed to serve, at the request of the Corporation, as a director, officer, partner, employee or trustee of, or in a similar capacity with, another corporation, partnership, joint venture, trust or other enterprise (including any employee benefit plan) (all such persons being referred to hereafter as an “Indemnitee”), or by reason of any action alleged to have been taken or omitted in such capacity, against all expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by or on behalf of Indemnitee in connection with such action, suit or proceeding and any appeal therefrom, if Indemnitee acted in good faith and in a manner which Indemnitee reasonably believed to be in, or not opposed to, the best interests of the Corporation, and, with respect to any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful. The termination of any action, suit or proceeding by judgment, order, settlement, conviction or upon a plea of nolo contendere or its equivalent, shall not, of itself, create a presumption that Indemnitee did not act in good faith and in a manner which Indemnitee reasonably believed to be in, or not opposed to, the best interests of the Corporation, and, with respect to any criminal action or proceeding, had reasonable cause to believe that his or her conduct was unlawful.

2. Actions or Suits by or in the Right of the Corporation . The Corporation shall indemnify any Indemnitee who was or is a party to or threatened to be made a party to any threatened, pending or completed action or suit by or in the right of the Corporation to procure a judgment in its favor by reason of the fact that Indemnitee is or was, or has agreed to become, a

 

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director or officer of the Corporation, or is or was serving, or has agreed to serve, at the request of the Corporation, as a director, officer, partner, employee or trustee of, or in a similar capacity with, another corporation, partnership, joint venture, trust or other enterprise (including any employee benefit plan), or by reason of any action alleged to have been taken or omitted in such capacity, against all expenses (including attorneys’ fees) and, to the extent permitted by law, amounts paid in settlement actually and reasonably incurred by or on behalf of Indemnitee in connection with such action, suit or proceeding and any appeal therefrom, if Indemnitee acted in good faith and in a manner which Indemnitee reasonably believed to be in, or not opposed to, the best interests of the Corporation, except that no indemnification shall be made under this Section 2 in respect of any claim, issue or matter as to which Indemnitee shall have been adjudged to be liable to the Corporation, unless, and only to the extent, that the Court of Chancery of Delaware shall determine upon application that, despite the adjudication of such liability but in view of all the circumstances of the case, Indemnitee is fairly and reasonably entitled to indemnity for such expenses (including attorneys’ fees) which the Court of Chancery of Delaware shall deem proper.

3. Indemnification for Expenses of Successful Party . Notwithstanding any other provisions of this Article, to the extent that an Indemnitee has been successful, on the merits or otherwise, in defense of any action, suit or proceeding referred to in Sections 1 and 2 of this Article EIGHTH, or in defense of any claim, issue or matter therein, or on appeal from any such action, suit or proceeding, Indemnitee shall be indemnified against all expenses (including attorneys’ fees) actually and reasonably incurred by or on behalf of Indemnitee in connection therewith. Without limiting the foregoing, if any action, suit or proceeding is disposed of, on the merits or otherwise (including a disposition without prejudice), without (i) the disposition being adverse to Indemnitee, (ii) an adjudication that Indemnitee was liable to the Corporation, (iii) a plea of guilty or nolo contendere by Indemnitee, (iv) an adjudication that Indemnitee did not act in good faith and in a manner he reasonably believed to be in or not opposed to the best interests of the Corporation, and (v) with respect to any criminal proceeding, an adjudication that Indemnitee had reasonable cause to believe his conduct was unlawful, Indemnitee shall be considered for the purposes hereof to have been wholly successful with respect thereto.

4. Notification and Defense of Claim . As a condition precedent to an Indemnitee’s right to be indemnified, such Indemnitee must notify the Corporation in writing as soon as practicable of any action, suit, proceeding or investigation involving such Indemnitee for which indemnity will or could be sought. With respect to any action, suit, proceeding or investigation of which the Corporation is so notified, the Corporation will be entitled to participate therein at its own expense and/or to assume the defense thereof at its own expense, with legal counsel reasonably acceptable to Indemnitee. After notice from the Corporation to Indemnitee of its election so to assume such defense, the Corporation shall not be liable to Indemnitee for any legal or other expenses subsequently incurred by Indemnitee in connection with such action, suit, proceeding or investigation, other than as provided below in this Section 4. Indemnitee shall have the right to employ his or her own counsel in connection with such action, suit, proceeding or investigation, but the fees and expenses of such counsel incurred after notice from the Corporation of its assumption of the defense thereof shall be at the expense of Indemnitee unless (i) the employment of counsel by Indemnitee has been authorized by the Corporation, (ii) counsel to Indemnitee shall have reasonably concluded that there may be a conflict of interest or position on any significant issue between the Corporation and Indemnitee in the conduct of

 

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the defense of such action, suit, proceeding or investigation or (iii) the Corporation shall not in fact have employed counsel to assume the defense of such action, suit, proceeding or investigation, in each of which cases the fees and expenses of counsel for Indemnitee shall be at the expense of the Corporation, except as otherwise expressly provided by this Article. The Corporation shall not be entitled, without the consent of Indemnitee, to assume the defense of any claim brought by or in the right of the Corporation or as to which counsel for Indemnitee shall have reasonably made the conclusion provided for in clause (ii) above. The Corporation shall not be required to indemnify Indemnitee under this Article EIGHTH for any amounts paid in settlement of any action, suit, proceeding or investigation effected without its written consent. The Corporation shall not settle any action, suit, proceeding or investigation in any manner which would impose any penalty or limitation on Indemnitee without Indemnitee’s written consent. Neither the Corporation nor Indemnitee will unreasonably withhold or delay its consent to any proposed settlement.

5. Advance of Expenses . Subject to the provisions of Section 6 of this Article EIGHTH, in the event of any action, suit, proceeding or investigation of which the Corporation receives notice under this Article, any expenses (including attorneys’ fees) incurred by or on behalf of Indemnitee in defending an action, suit, proceeding or investigation or any appeal therefrom shall be paid by the Corporation in advance of the final disposition of such matter; provided , however, that the payment of such expenses incurred by or on behalf of Indemnitee in advance of the final disposition of such matter shall be made only upon receipt of an undertaking by or on behalf of Indemnitee to repay all amounts so advanced in the event that it shall ultimately be determined that Indemnitee is not entitled to be indemnified by the Corporation as authorized in this Article; and further provided that no such advancement of expenses shall be made under this Article EIGHTH if it is determined (in the manner described in Section 6) that (i) Indemnitee did not act in good faith and in a manner he reasonably believed to be in, or not opposed to, the best interests of the Corporation, or (ii) with respect to any criminal action or proceeding, Indemnitee had reasonable cause to believe his conduct was unlawful. Such undertaking shall be accepted without reference to the financial ability of Indemnitee to make such repayment.

6. Procedure for Indemnification . In order to obtain indemnification or advancement of expenses pursuant to Section 1, 2, 3 or 5 of this Article EIGHTH, an Indemnitee shall submit to the Corporation a written request. Any such advancement of expenses shall be made promptly, and in any event within 60 days after receipt by the Corporation of the written request of Indemnitee, unless (i) the Corporation has assumed the defense pursuant to Section 4 of this Article EIGHTH (and none of the circumstances described in Section 4 of this Article EIGHTH that would nonetheless entitle the Indemnitee to indemnification for the fees and expenses of separate counsel have occurred) or (ii) the Corporation determines within such 60-day period that Indemnitee did not meet the applicable standard of conduct set forth in Section 1, 2 or 5 of this Article EIGHTH, as the case may be. Any such indemnification, unless ordered by a court, shall be made with respect to requests under Section 1 or 2 only as authorized in the specific case upon a determination by the Corporation that the indemnification of Indemnitee is proper because Indemnitee has met the applicable standard of conduct set forth in Section 1 or 2, as the case may be. Such determination shall be made in each instance (a) by a majority vote of the directors of the Corporation consisting of persons who are not at that time parties to the action, suit or proceeding in question (“disinterested directors”), whether or not a

 

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quorum, (b) by a committee of disinterested directors designated by majority vote of disinterested directors, whether or not a quorum, (c) if there are no disinterested directors, or if the disinterested directors so direct, by independent legal counsel (who may, to the extent permitted by law, be regular legal counsel to the Corporation) in a written opinion, or (d) by the stockholders of the Corporation.

7. Remedies . The right to indemnification or advancement of expenses as granted by this Article shall be enforceable by Indemnitee in any court of competent jurisdiction. Neither the failure of the Corporation to have made a determination prior to the commencement of such action that indemnification is proper in the circumstances because Indemnitee has met the applicable standard of conduct, nor an actual determination by the Corporation pursuant to Section 6 of this Article EIGHTH that Indemnitee has not met such applicable standard of conduct, shall be a defense to the action or create a presumption that Indemnitee has not met the applicable standard of conduct. Indemnitee’s expenses (including attorneys’ fees) reasonably incurred in connection with successfully establishing Indemnitee’s right to indemnification, in whole or in part, in any such proceeding shall also be indemnified by the Corporation.

8. Limitations . Notwithstanding anything to the contrary in this Article, except as set forth in Section 7 of the Article EIGHTH, the Corporation shall not indemnify an Indemnitee pursuant to this Article EIGHTH in connection with a proceeding (or part thereof) initiated by such Indemnitee unless the initiation thereof was approved by the Board of Directors of the Corporation. Notwithstanding anything to the contrary in this Article, the Corporation shall not indemnify an Indemnitee to the extent such Indemnitee is reimbursed from the proceeds of insurance, and in the event the Corporation makes any indemnification payments to an Indemnitee and such Indemnitee is subsequently reimbursed from the proceeds of insurance, such Indemnitee shall promptly refund indemnification payments to the Corporation to the extent of such insurance reimbursement.

9. Subsequent Amendment . No amendment, termination or repeal of this Article or of the relevant provisions of the General Corporation Law of Delaware or any other applicable laws shall affect or diminish in any way the rights of any Indemnitee to indemnification under the provisions hereof with respect to any action, suit, proceeding or investigation arising out of or relating to any actions, transactions or facts occurring prior to the final adoption of such amendment, termination or repeal.

10. Other Rights . The indemnification and advancement of expenses provided by this Article shall not be deemed exclusive of any other rights to which an Indemnitee seeking indemnification or advancement of expenses may be entitled under any law (common or statutory), agreement or vote of stockholders or disinterested directors or otherwise, both as to action in Indemnitee’s official capacity and as to action in any other capacity while holding office for the Corporation, and shall continue as to an Indemnitee who has ceased to be a director or officer, and shall inure to the benefit of the estate, heirs, executors and administrators of Indemnitee. Nothing contained in this Article shall be deemed to prohibit, and the Corporation is specifically authorized to enter into, agreements with officers and directors providing indemnification rights and procedures different from those set forth in this Article. In addition, the Corporation may, to the extent authorized from time to time by its Board of Directors, grant indemnification rights to other employees or agents of the Corporation or other persons serving the Corporation and such rights may be equivalent to, or greater or less than, those set forth in this Article.

 

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11. Partial Indemnification . If an Indemnitee is entitled under any provision of this Article to indemnification by the Corporation for some or a portion of the expenses (including attorneys’ fees), judgments, fines or amounts paid in settlement actually and reasonably incurred by or on behalf of Indemnitee in connection with any action, suit, proceeding or investigation and any appeal therefrom but not, however, for the total amount thereof, the Corporation shall nevertheless indemnify Indemnitee for the portion of such expenses (including attorneys’ fees), judgments, fines or amounts paid in settlement to which Indemnitee is entitled.

12. Insurance . The Corporation may purchase and maintain insurance, at its expense, to protect itself and any director, officer, employee or agent of the Corporation or another corporation, partnership, joint venture, trust or other enterprise (including any employee benefit plan) against any expense, liability or loss incurred by him in any such capacity, or arising out of his status as such, whether or not the Corporation would have the power to indemnify such person against such expense, liability or loss under the General Corporation Law of Delaware.

13. Savings Clause . If this Article or any portion hereof shall be invalidated on any ground by any court of competent jurisdiction, then the Corporation shall nevertheless indemnify each Indemnitee as to any expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement in connection with any action, suit, proceeding or investigation, whether civil, criminal or administrative, including an action by or in the right of the Corporation, to the fullest extent permitted by any applicable portion of this Article that shall not have been invalidated and to the fullest extent permitted by applicable law.

14. Definitions . Terms used herein and defined in Section 145(h) and Section 145(i) of the General Corporation Law of Delaware shall have the respective meanings assigned to such terms in such Section 145(h) and Section 145(i).

NINTH: This Article is inserted for the management of the business and for the conduct of the affairs of the Corporation.

1. General Powers . The business and affairs of the Corporation shall be managed by or under the direction of the Board of Directors.

2. Number of Directors; Election of Directors . Subject to the rights of holders of any series of Preferred Stock to elect directors, the number of directors of the Corporation shall be established by the Board of Directors. Election of directors need not be by written ballot, except as and to the extent provided in the By-laws of the Corporation.

3. Classes of Directors . Subject to the rights of holders of any series of Preferred Stock to elect directors, the Board of Directors shall be and is divided into three classes, as nearly equal in number as possible, designated Class I, Class II and Class III. The Board of Directors is authorized to assign members of the Board of Directors already in office to Class I, Class II or Class III.

4. Terms of Office . Subject to the rights of holders of any series of Preferred Stock to elect directors, each director shall serve for a term ending on the date of the third annual meeting following the annual meeting at which such director was elected; provided, that each

 

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director initially appointed to Class I shall serve for a term expiring at the Corporation’s first annual meeting of stockholders; each director initially appointed to Class II shall serve for a term expiring at the Corporation’s second annual meeting of stockholders; and each director initially appointed to Class III shall serve for a term expiring at the Corporation’s third annual meeting of stockholders; provided further, that the term of each director shall continue until the election and qualification of his successor and be subject to his earlier death, resignation or removal.

5. Quorum . The greater of (a) a majority of the directors at any time in office and (b) one-third of the number of directors fixed pursuant to Section 2 of this Article NINTH shall constitute a quorum. If at any meeting of the Board of Directors there shall be less than such a quorum, a majority of the directors present may adjourn the meeting from time to time without further notice other than announcement at the meeting, until a quorum shall be present.

6. Action at Meeting . 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 unless a greater number is required by law or by this Certificate of Incorporation.

7. Removal . Subject to the rights of holders of any series of Preferred Stock, directors of the Corporation may be removed only for cause and only by the affirmative vote of the holders of at least seventy-five percent (75%) of the votes which all the stockholders would be entitled to cast in an election of directors.

8. Vacancies . Subject to the rights of holders of any series of Preferred Stock, any vacancy or newly created directorships in the Board of Directors, however occurring, shall be filled only by vote of a majority of the directors then in office, although less than a quorum, or by a sole remaining director and shall not be filled by the stockholders. A director elected to fill a vacancy shall hold office until the next election of the class for which such director shall have been chosen, subject to the election and qualification of a successor and to such director’s earlier death, resignation or removal.

9. Stockholder Nominations and Introduction of Business, Etc . Advance notice of stockholder nominations for election of directors and other business to be brought by stockholders before a meeting of stockholders shall be given in the manner provided by the By-laws of the Corporation.

10. Amendments to Article . Notwithstanding any other provisions of law, this Certificate of Incorporation or the By-laws of the Corporation, and notwithstanding the fact that a lesser percentage may be specified by law, the affirmative vote of the holders of at least seventy-five percent (75%) of the votes which all the stockholders would be entitled to cast in an election of directors shall be required to amend or repeal, or to adopt any provision inconsistent with, this Article NINTH.

TENTH: Stockholders of the Corporation may not take any action by written consent in lieu of a meeting. Notwithstanding any other provisions of law, this Certificate of Incorporation or the By-laws of the Corporation, and notwithstanding the fact that a lesser percentage may be

 

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specified by law, the affirmative vote of the holders of at least seventy-five percent (75%) of the votes which all the stockholders would be entitled to cast in any annual election of directors or class of directors shall be required to amend or repeal, or to adopt any provision inconsistent with, this Article TENTH.

ELEVENTH: Special meetings of stockholders for any purpose or purposes may be called at any time by the Board of Directors, the Chairman of the Board or the President, but such special meetings may not be called by any other person or persons. Business transacted at any special meeting of stockholders shall be limited to matters relating to the purpose or purposes stated in the notice of meeting. Notwithstanding any other provision of law, this Certificate of Incorporation or the By-laws of the Corporation, and notwithstanding the fact that a lesser percentage may be specified by law, the affirmative vote of the holders of at least seventy-five percent (75%) of the votes which all the stockholders would be entitled to cast in any annual election of directors or class of directors shall be required to amend or repeal, or to adopt any provision inconsistent with, this Article ELEVENTH.

IN WITNESS WHEREOF, this Restated Certificate of Incorporation, which restates, integrates and amends the certificate of incorporation of the Corporation, and which has been duly adopted in accordance with Sections 228, 242 and 245 of the Delaware General Corporation Law, has been executed by its duly authorized officer this      day of              , 2006.

 

ACHILLION PHARMACEUTICALS, INC.
By:  

 

Name:   Michael D. Kishbauch
Title:   President

 

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Exhibit 3.5

AMENDED AND RESTATED BY-LAWS

OF

ACHILLION PHARMACEUTICALS, INC.


TABLE OF CONTENTS

 

         Page
ARTICLE I  

STOCKHOLDERS

   1
            1.1  

Place of Meetings

   1
            1.2  

Annual Meeting

   1
            1.3  

Special Meetings

   1
            1.4  

Notice of Meetings

   1
            1.5  

Voting List

   1
            1.6  

Quorum

   2
            1.7  

Adjournments

   2
            1.8  

Voting and Proxies

   2
            1.9  

Action at Meeting

   2
            1.10  

Nomination of Directors.

   3
            1.11  

Notice of Business at Annual Meetings.

   5
            1.12  

Conduct of Meetings.

   7
            1.13  

No Action by Consent in Lieu of a Meeting

   8
ARTICLE II  

DIRECTORS

   8
            2.1  

General Powers

   8
            2.2  

Number, Election and Qualification

   8
            2.3  

Classes of Directors

   8
            2.4  

Terms of Office

   8
            2.5  

Quorum

   8
            2.6  

Action at Meeting

   8
            2.7  

Removal

   8
            2.8  

Vacancies

   9
            2.9  

Resignation

   9
            2.10  

Regular Meetings

   9
            2.11  

Special Meetings

   9
            2.12  

Notice of Special Meetings

   9
            2.13  

Meetings by Conference Communications Equipment

   9
            2.14  

Action by Consent

   9
            2.15  

Committees

   10
            2.16  

Compensation of Directors

   10
ARTICLE III  

OFFICERS

   10
            3.1  

Titles

   10
            3.2  

Election

   10
            3.3  

Qualification

   10
            3.4  

Tenure

   11
            3.5  

Resignation and Removal

   11
            3.6  

Vacancies

   11
            3.7  

Chairman of the Board

   11
            3.8  

President; Chief Executive Officer

   11
            3.9  

Vice Presidents

   12

 

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            3.10   

Secretary and Assistant Secretaries

   12
            3.11   

Treasurer and Assistant Treasurers

   12
            3.12   

Salaries

   12
ARTICLE IV   

CAPITAL STOCK

   13
            4.1   

Issuance of Stock

   13
            4.2   

Certificates of Stock

   13
            4.3   

Transfers

   13
            4.4   

Lost, Stolen or Destroyed Certificates

   13
            4.5   

Record Date

   14
ARTICLE V   

GENERAL PROVISIONS

   14
            5.1   

Fiscal Year

   14
            5.2   

Corporate Seal

   14
            5.3   

Waiver of Notice

   14
            5.4   

Voting of Securities

   14
            5.5   

Evidence of Authority

   15
            5.6   

Certificate of Incorporation

   15
            5.7   

Severability

   15
            5.8   

Pronouns

   15
ARTICLE VI   

AMENDMENTS

   15

 

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ARTICLE I

STOCKHOLDERS

1.1 Place of Meetings . All meetings of stockholders shall be held at such place as may be designated from time to time by the Board of Directors, the Chairman of the Board, the Chief Executive Officer or the President or, if not so designated, at the principal office of the corporation.

1.2 Annual Meeting . The annual meeting of stockholders for the election of directors and for the transaction of such other business as may properly be brought before the meeting shall be held on a date and at a time designated by the Board of Directors, the Chairman of the Board, the Chief Executive Officer or the President (which date shall not be a legal holiday in the place where the meeting is to be held). If no annual meeting is held in accordance with the foregoing provisions, a special meeting may be held in lieu of the annual meeting, and any action taken at that special meeting shall have the same effect as if it had been taken at the annual meeting, and in such case all references in these By-laws to the annual meeting of the stockholders shall be deemed to refer to such special meeting.

1.3 Special Meetings . Special meetings of stockholders for any purpose or purposes may be called at any time by the Board of Directors, the Chairman of the Board, the Chief Executive Officer or the President, but such special meetings may not be called by any other person or persons. Business transacted at any special meeting of stockholders shall be limited to matters relating to the purpose or purposes stated in the notice of meeting.

1.4 Notice of Meetings . Except as otherwise provided by law, notice of each meeting of stockholders, whether annual or special, shall be given not less than 10 nor more than 60 days before the date of the meeting to each stockholder entitled to vote at such meeting. Without limiting the manner by which notice otherwise may be given to stockholders, any notice shall be effective if given by a form of electronic transmission consented to (in a manner consistent with the General Corporation Law of the State of Delaware) by the stockholder to whom the notice is given. The notices of all meetings shall state the place, date and time of the meeting and the means of remote communications, if any, by which stockholders and proxyholders may be deemed to be present in person and vote at such meeting. The notice of a special meeting shall state, in addition, the purpose or purposes for which the meeting is called. If notice is given by mail, such notice shall be deemed given when deposited in the United States mail, postage prepaid, directed to the stockholder at such stockholder’s address as it appears on the records of the corporation. If notice is given by electronic transmission, such notice shall be deemed given at the time specified in Section 232 of the General Corporation Law of the State of Delaware.

1.5 Voting List . The Secretary shall prepare, at least 10 days before every meeting of stockholders, a complete list of the stockholders entitled to vote at the meeting, arranged in alphabetical order, and showing the address of each stockholder and the number of shares registered in the name of each stockholder. Such list shall be open to the examination of any stockholder, for any purpose germane to the meeting, for a period of at least 10 days prior to the meeting: (a) on a reasonably accessible electronic network, provided that the information required to gain access to such list is provided with notice of the meeting, or (b) during ordinary


business hours, at the principal place of business of the corporation. The list shall also be produced and kept at the time and place of the meeting during the whole time thereof, and may be inspected by any stockholder who is present.

1.6 Quorum . Except as otherwise provided by law, the Certificate of Incorporation or these By-laws, the holders of a majority in voting power of the shares of the capital stock of the corporation issued and outstanding and entitled to vote at the meeting, present in person, present by means of remote communication in a manner, if any, authorized by the Board of Directors in its sole discretion, or represented by proxy, shall constitute a quorum for the transaction of business. A quorum, once established at a meeting, shall not be broken by the withdrawal of enough votes to leave less than a quorum.

1.7 Adjournments . Any meeting of stockholders may be adjourned from time to time to any other time and to any other place at which a meeting of stockholders may be held under these By-laws by the stockholders present or represented at the meeting and entitled to vote, although less than a quorum, or, if no stockholder is present, by any officer entitled to preside at or to act as secretary of such meeting. It shall not be necessary to notify any stockholder of any adjournment of less than 30 days if the time and place of the adjourned meeting, and the means of remote communication, if any, by which stockholders and proxyholders may be deemed to be present in person and vote at such adjourned meeting, are announced at the meeting at which adjournment is taken, unless after the adjournment a new record date is fixed for the adjourned meeting. At the adjourned meeting, the corporation may transact any business which might have been transacted at the original meeting.

1.8 Voting and Proxies . Each stockholder shall have one vote for each share of stock entitled to vote held of record by such stockholder and a proportionate vote for each fractional share so held, unless otherwise provided by law or the Certificate of Incorporation. Each stockholder of record entitled to vote at a meeting of stockholders may vote in person (including by means of remote communications, if any, by which stockholders may be deemed to be present in person and vote at such meeting) or may authorize another person or persons to vote for such stockholder by a proxy executed or transmitted in a manner permitted by the General Corporation Law of the State of Delaware by the stockholder or such stockholder’s authorized agent and delivered (including by electronic transmission) to the Secretary of the corporation. No such proxy shall be voted upon after three years from the date of its execution, unless the proxy expressly provides for a longer period.

1.9 Action at Meeting . When a quorum is present at any meeting, any matter other than the election of directors to be voted upon by the stockholders at such meeting shall be decided by the affirmative vote of the holders of a majority in voting power of the shares of stock present or represented and voting on such matter (or if there are two or more classes of stock entitled to vote as separate classes, then in the case of each such class, the holders of a majority in voting power of the shares of stock of that class present or represented and voting on such matter), except when a different vote is required by law, the Certificate of Incorporation or these By-laws. When a quorum is present at any meeting, any election by stockholders of directors shall be determined by a plurality of the votes cast by the stockholders entitled to vote on the election.

 

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1.10 Nomination of Directors .

(a) Except for (1) any directors entitled to be elected by the holders of preferred stock, (2) any directors elected in accordance with Section 2.9 hereof by the Board of Directors to fill a vacancy or newly-created directorships or (3) as otherwise required by applicable law or stock market regulation, only persons who are nominated in accordance with the procedures in this Section 1.10 shall be eligible for election as directors. Nomination for election to the Board of Directors at a meeting of stockholders may be made (i) by or at the direction of the Board of Directors or (ii) by any stockholder of the corporation who (x) complies with the notice procedures set forth in Section 1.10(b) and (y) is a stockholder of record on the date of the giving of such notice and on the record date for the determination of stockholders entitled to vote at such meeting.

(b) To be timely, a stockholder’s notice must be received in writing by the Secretary at the principal executive offices of the corporation as follows: (i) in the case of an election of directors at an annual meeting of stockholders, not less than 90 days nor more than 120 days prior to the first anniversary of the preceding year’s annual meeting; provided, however, that (x) in the case of the annual meeting of stockholders of the corporation to be held in 2007 or (y) in the event that the date of the annual meeting in any other year is advanced by more than 20 days, or delayed by more than 60 days, from the first anniversary of the preceding year’s annual meeting, a stockholder’s notice must be so received not earlier than the 120th day prior to such annual meeting and not later than the close of business on the later of (A) the 90th day prior to such annual meeting and (B) the tenth day following the day on which notice of the date of such annual meeting was mailed or public disclosure of the date of such annual meeting was made, whichever first occurs; or (ii) in the case of an election of directors at a special meeting of stockholders, provided that the Board of Directors has determined that directors shall be elected at such meeting, not earlier than the 120th day prior to such special meeting and not later than the close of business on the later of (x) the 90th day prior to such special meeting and (y) the tenth day following the day on which notice of the date of such special meeting was mailed or public disclosure of the date of such special meeting was made, whichever first occurs. In no event shall the adjournment or postponement of an annual meeting (or the public announcement thereof) commence a new time period (or extend any time period) for the giving of a stockholder’s notice.

The stockholder’s notice to the Secretary shall set forth: (A) as to each proposed nominee (1) such person’s name, age, business address and, if known, residence address, (2) such person’s principal occupation or employment, (3) the class and number of shares of stock of the corporation which are beneficially owned by such person, and (4) any other information concerning such person that must be disclosed as to nominees in proxy solicitations pursuant to Regulation 14A under the Securities Exchange Act of 1934, as amended (the “Exchange Act”); (B) as to the stockholder giving the notice (1) such stockholder’s name and address, as they appear on the corporation’s books, (2) the class and number of shares of stock of the corporation which are owned, beneficially and of record, by such stockholder, (3) a description of all arrangements or understandings between such stockholder and each proposed nominee and any other person or persons (including their names) pursuant to which the nomination(s) are to be made by such stockholder, (4) a representation that such stockholder intends to appear in person or by proxy at the meeting to nominate the person(s) named in its notice and (5) a representation

 

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whether the stockholder intends or is part of a group which intends (x) to deliver a proxy statement and/or form of proxy to holders of at least the percentage of the corporation’s outstanding capital stock required to elect the nominee and/or (y) otherwise to solicit proxies from stockholders in support of such nomination; and (C) as to the beneficial owner, if any, on whose behalf the nomination is being made (1) such beneficial owner’s name and address, (2) the class and number of shares of stock of the corporation which are beneficially owned by such beneficial owner, (3) a description of all arrangements or understandings between such beneficial owner and each proposed nominee and any other person or persons (including their names) pursuant to which the nomination(s) are to be made and (4) a representation whether the beneficial owner intends or is part of a group which intends (x) to deliver a proxy statement and/or form of proxy to holders of at least the percentage of the corporation’s outstanding capital stock requirement to elect the nominee and/or (y) otherwise to solicit proxies from stockholders in support of such nomination. In addition, to be effective, the stockholder’s notice must be accompanied by the written consent of the proposed nominee to serve as a director if elected. The corporation may require any proposed nominee to furnish such other information as may reasonably be required to determine the eligibility of such proposed nominee to serve as a director of the corporation. A stockholder shall not have complied with this Section 1.10(b) if the stockholder (or beneficial owner, if any, on whose behalf the nomination is made) solicits or does not solicit, as the case may be, proxies in support of such stockholder’s nominee in contravention of the representations with respect thereto required by this Section 1.10.

(c) The chairman of any meeting shall have the power and duty to determine whether a nomination was made in accordance with the provisions of this Section 1.10 (including whether the stockholder or beneficial owner, if any, on whose behalf the nomination is made solicited (or is part of a group which solicited) or did not so solicit, as the case may be, proxies in support of such stockholder’s nominee in compliance with the representations with respect thereto required by this Section 1.10), and if the chairman should determine that a nomination was not made in accordance with the provisions of this Section 1.10, the chairman shall so declare to the meeting and such nomination shall be disregarded.

(d) Except as otherwise required by law, nothing in this Section 1.10 shall obligate the corporation or the Board of Directors to include in any proxy statement or other stockholder communication distributed on behalf of the corporation or the Board of Directors information with respect to any nominee for director submitted by a stockholder.

(e) Notwithstanding the foregoing provisions of this Section 1.10, if the stockholder (or a qualified representative of the stockholder) does not appear at the annual or special meeting of stockholders of the corporation to present a nomination, such nomination shall be disregarded, notwithstanding that proxies in respect of such vote may have been received by the corporation. For purposes of this Section 1.10, to be considered a qualified representative of the stockholder, a person must be authorized by a written instrument executed by such stockholder or an electronic transmission delivered by such stockholder to act for such stockholder as proxy at the meeting of stockholders and such person must produce such written instrument or electronic transmission, or a reliable reproduction of the written instrument or electronic transmission, at the meeting of stockholders.

 

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(f) For purposes of this Section 1.10, “public disclosure” shall include disclosure in a press release reported by the Dow Jones New Service, Associated Press or comparable national news service or in a document publicly filed by the corporation with the Securities and Exchange Commission pursuant to Section 13, 14 or 15(d) of the Exchange Act.

1.11 Notice of Business at Annual Meetings .

(a) At any annual meeting of the stockholders, only such business shall be conducted as shall have been properly brought before the meeting. To be properly brought before an annual meeting, business must be (1) specified in the notice of meeting (or any supplement thereto) given by or at the direction of the Board of Directors, (2) otherwise properly brought before the meeting by or at the direction of the Board of Directors, or (3) properly brought before the meeting by a stockholder. For business to be properly brought before an annual meeting by a stockholder, (i) if such business relates to the nomination of a person for election as a director of the corporation, the procedures in Section 1.10 must be complied with and (ii) if such business relates to any other matter, the business must constitute a proper matter under Delaware law for stockholder action and the stockholder must (x) have given timely notice thereof in writing to the Secretary in accordance with the procedures set forth in Section 1.11(b) and (y) be a stockholder of record on the date of the giving of such notice and on the record date for the determination of stockholders entitled to vote at such annual meeting.

(b) To be timely, a stockholder’s notice must be received in writing by the Secretary at the principal executive offices of the corporation not less than 90 days nor more than 120 days prior to the first anniversary of the preceding year’s annual meeting; provided, however, that (x) in the case of the annual meeting of stockholders of the corporation to be held in 2007 or (y) in the event that the date of the annual meeting in any other year is advanced by more than 20 days, or delayed by more than 60 days, from the first anniversary of the preceding year’s annual meeting, a stockholder’s notice must be so received not earlier than the 120th day prior to such annual meeting and not later than the close of business on the later of (A) the 90th day prior to such annual meeting and (B) the tenth day following the day on which notice of the date of such annual meeting was mailed or public disclosure of the date of such annual meeting was made, whichever first occurs. In no event shall the adjournment or postponement of an annual meeting (or the public announcement thereof) commence a new time period (or extend any time period) for the giving of a stockholder’s notice.

The stockholder’s notice to the Secretary shall set forth as to each matter the stockholder proposes to bring before the annual meeting (1) a brief description of the business desired to be brought before the annual meeting, the text relating to the business (including the text of any resolutions proposed for consideration and in the event that such business includes a proposal to amend the By-laws, the language of the proposed amendment), and the reasons for conducting such business at the annual meeting, (2) the name and address, as they appear on the corporation’s books, of the stockholder proposing such business, and the name and address of the beneficial owner, if any, on whose behalf the proposal is made, (3) the class and number of shares of stock of the corporation which are owned, of record and beneficially, by the stockholder and beneficial owner, if any, (4) a description of all arrangements or understandings between such stockholder or such beneficial owner, if any, and any other person or persons (including their names) in connection with the proposal of such business by such stockholder and

 

5


any material interest of the stockholder or such beneficial owner, if any, in such business, (5) a representation that such stockholder intends to appear in person or by proxy at the annual meeting to bring such business before the meeting and (6) a representation whether the stockholder or the beneficial owner, if any, intends or is part of a group which intends (x) to deliver a proxy statement and/or form of proxy to holders of at least the percentage of the corporation’s outstanding capital stock required to approve or adopt the proposal and/or (y) otherwise to solicit proxies from stockholders in support of such proposal. Notwithstanding anything in these By-laws to the contrary, no business shall be conducted at any annual meeting of stockholders except in accordance with the procedures set forth in this Section 1.11; provided that any stockholder proposal which complies with Rule 14a-8 of the proxy rules (or any successor provision) promulgated under the Securities Exchange Act of 1934, as amended, and is to be included in the corporation’s proxy statement for an annual meeting of stockholders shall be deemed to comply with the requirements of this Section 1.11. A stockholder shall not have complied with this Section 1.11(b) if the stockholder (or beneficial owner, if any, on whose behalf the nomination is made) solicits or does not solicit, as the case may be, proxies in support of such stockholder’s proposal in contravention of the representations with respect thereto required by this Section 1.11.

(c) The chairman of any meeting shall have the power and duty to determine whether business was properly brought before the meeting in accordance with the provisions of this Section 1.11 (including whether the stockholder or beneficial owner, if any, on whose behalf the proposal is made solicited (or is part of a group which solicited) or did not so solicit, as the case may be, proxies in support of such stockholder’s proposal in compliance with the representation with respect thereto required by this Section 1.11), and if the chairman should determine that business was not properly brought before the meeting in accordance with the provisions of this Section 1.11, the chairman shall so declare to the meeting and such business shall not be brought before the meeting.

(d) Notwithstanding the foregoing provisions of this Section 1.11, if the stockholder (or a qualified representative of the stockholder) does not appear at the annual meeting of stockholders of the corporation to present business, such business shall not be considered, notwithstanding that proxies in respect of such vote may have been received by the corporation. For purposes of this Section 1.11, to be considered a qualified representative of the stockholder, a person must be authorized by a written instrument executed by the such stockholder or an electronic transmission delivered by such stockholder to act for such stockholder as a proxy at the meeting of stockholders and such person must produce such written instrument or electronic transmission, or a reliable reproduction of the written instrument or electronic transmission, at the meeting of stockholders.

(e) For purposes of this Section 1.11, “public disclosure” shall include disclosure in a press release reported by the Dow Jones New Service, Associated Press or comparable national news service or in a document publicly filed by the corporation with the Securities and Exchange Commission pursuant to Section 13, 14 or 15(d) of the Exchange Act.

 

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1.12 Conduct of Meetings .

(a) Meetings of stockholders shall be presided over by the Chairman of the Board, if any, or in the Chairman’s absence by the Vice Chairman of the Board, if any, or in the Vice Chairman’s absence by the Chief Executive Officer, or in the Chief Executive Officer’s absence, by the President, or in the President’s absence by a Vice President, or in the absence of all of the foregoing persons by a chairman designated by the Board of Directors, or in the absence of such designation by a chairman chosen by vote of the stockholders at the meeting. The Secretary shall act as secretary of the meeting, but in the Secretary’s absence the chairman of the meeting may appoint any person to act as secretary of the meeting.

(b) The Board of Directors may adopt by resolution such rules, regulations and procedures for the conduct of any meeting of stockholders of the corporation as it shall deem appropriate including, without limitation, such guidelines and procedures as it may deem appropriate regarding the participation by means of remote communication of stockholders and proxyholders not physically present at a meeting. Except to the extent inconsistent with such rules, regulations and procedures as adopted by the Board of Directors, the chairman of any meeting of stockholders shall have the right and authority to prescribe such rules, regulations and procedures and to do all such acts as, in the judgment of such chairman, are appropriate for the proper conduct of the meeting. Such rules, regulations or procedures, whether adopted by the Board of Directors or prescribed by the chairman of the meeting, may include, without limitation, the following: (i) the establishment of an agenda or order of business for the meeting; (ii) rules and procedures for maintaining order at the meeting and the safety of those present; (iii) limitations on attendance at or participation in the meeting to stockholders of record of the corporation, their duly authorized and constituted proxies or such other persons as shall be determined; (iv) restrictions on entry to the meeting after the time fixed for the commencement thereof; and (v) limitations on the time allotted to questions or comments by participants. Unless and to the extent determined by the Board of Directors or the chairman of the meeting, meetings of stockholders shall not be required to be held in accordance with the rules of parliamentary procedure.

(c) The chairman of the meeting shall announce at the meeting when the polls for each matter to be voted upon at the meeting will be opened and closed. If no announcement is made, the polls shall be deemed to have opened when the meeting is convened and closed upon the final adjournment of the meeting. After the polls close, no ballots, proxies or votes or any revocations or changes thereto may be accepted.

(d) In advance of any meeting of stockholders, the Board of Directors, the Chairman of the Board, the Chief Executive Officer or the President shall appoint one or more inspectors of election to act at the meeting and make a written report thereof. One or more other persons may be designated as alternate inspectors to replace any inspector who fails to act. If no inspector or alternate is present, ready and willing to act at a meeting of stockholders, the chairman of the meeting shall appoint one or more inspectors to act at the meeting. Unless otherwise required by law, inspectors may be officers, employees or agents of the corporation. Each inspector, before entering upon the discharge of such inspector’s duties, shall take and sign an oath faithfully to execute the duties of inspector with strict impartiality and according to the best of such inspector’s ability. The inspector shall have the duties prescribed by law and shall take charge of the polls and, when the vote in completed, shall make a certificate of the result of the vote taken and of such other facts as may be required by law.

 

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1.13 No Action by Consent in Lieu of a Meeting . Stockholders of the corporation may not take any action by written consent in lieu of a meeting.

ARTICLE II

DIRECTORS

2.1 General Powers . The business and affairs of the corporation shall be managed by or under the direction of a Board of Directors, who may exercise all of the powers of the corporation except as otherwise provided by law or the Certificate of Incorporation.

2.2 Number, Election and Qualification . Subject to the rights of holders of any series of Preferred Stock to elect directors, the number of directors of the Corporation shall be established by the Board of Directors. Election of directors need not be by written ballot. Directors need not be stockholders of the corporation.

a) Classes of Directors . Subject to the rights of holders of any series of Preferred Stock to elect directors, the Board of Directors shall be and is divided into three classes, as nearly equal in number as possible, designated Class I, Class II and Class III. The Board of Directors is authorized to assign members already in office to Class I, Class II or Class III.

2.3 Terms of Office . Subject to the rights of holders of any series of Preferred Stock to elect directors, each director shall serve for a term ending on the date of the third annual meeting following the annual meeting at which such director was elected; provided , that each director initially appointed to Class I shall serve for a term expiring at the corporation’s first annual meeting of stockholders; each director initially appointed to Class II shall serve for a term expiring at the corporation’s second annual meeting of stockholders; and each director initially appointed to Class III shall serve for a term expiring at the corporation’s third annual meeting of stockholders; provided further , that the term of each director shall continue until the election and qualification of a successor and be subject to such director’s earlier death, resignation or removal.

2.4 Quorum . The greater of (a) a majority of the directors at any time in office and (b) one-third of the number of directors fixed by the Board of Directors shall constitute a quorum. If at any meeting of the Board of Directors there shall be less than such a quorum, a majority of the directors present may adjourn the meeting from time to time without further notice other than announcement at the meeting, until a quorum shall be present.

2.5 Action at Meeting . 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 unless a greater number is required by law or by the Certificate of Incorporation.

2.6 Removal . Subject to the rights of holder of any series of Preferred Stock, directors of the corporation may be removed only for cause and only by the affirmative vote of the holders of at least 75% of the votes which all the stockholders would be entitled to cast in an election of directors.

 

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2.7 Vacancies . Subject to the rights of holder of any series of Preferred Stock, any vacancy or newly-created directorships on the Board of Directors, however occurring, shall be filled only by vote of a majority of the directors then in office, although less than a quorum, or by a sole remaining director and shall not be filled by the stockholders. A director elected to fill a vacancy shall hold office until the next election of the class for which such director shall have been chosen, subject to the election and qualification of a successor or until such director’s earlier death, resignation or removal.

2.8 Resignation . Any director may resign by delivering a resignation in writing or by electronic transmission to the corporation at its principal office or to the Chairman of the Board, the Chief Executive Officer, the President or the Secretary. Such resignation shall be effective upon receipt unless it is specified to be effective at some later time or upon the happening of some later event.

2.9 Regular Meetings . Regular meetings of the Board of Directors may be held without notice at such time and place as shall be determined from time to time by the Board of Directors; provided that any director who is absent when such a determination is made shall be given notice of the determination. A regular meeting of the Board of Directors may be held without notice immediately after and at the same place as the annual meeting of stockholders.

2.10 Special Meetings . Special meetings of the Board of Directors may be held at any time and place designated in a call by the Chairman of the Board, the Chief Executive Officer, the President, two or more directors, or by one director in the event that there is only a single director in office.

2.11 Notice of Special Meetings . Notice of any special meeting of directors shall be given to each director by the Secretary or by the officer or one of the directors calling the meeting. Notice shall be duly given to each director (a) in person or by telephone at least 24 hours in advance of the meeting, (b) by sending written notice via reputable overnight courier, telecopy or electronic mail, or delivering written notice by hand, to such director’s last known business, home or electronic mail address at least 48 hours in advance of the meeting, or (c) by sending written notice via first-class mail to such director’s last known business or home address at least 72 hours in advance of the meeting. A notice or waiver of notice of a meeting of the Board of Directors need not specify the purposes of the meeting.

2.12 Meetings by Conference Communications Equipment . Directors may participate in meetings of the Board of Directors or any committee thereof by means of conference telephone or other communications equipment by means of which all persons participating in the meeting can hear each other, and participation by such means shall constitute presence in person at such meeting.

2.13 Action by Consent . Any action required or permitted to be taken at any meeting of the Board of Directors or of any committee thereof may be taken without a meeting, if all members of the Board of Directors or committee, as the case may be, consent to the action in writing or by electronic transmission, and the written consents or electronic transmissions are filed with the minutes of proceedings of the Board of Directors or committee.

 

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2.14 Committees . The Board of Directors may designate one or more committees, each committee to consist of one or more of the directors of the corporation. The Board of Directors may designate one or more directors as alternate members of any committee, who may replace any absent or disqualified member at any meeting of the committee. In the absence or disqualification of a member of a committee, the member or members of the committee present at any meeting and not disqualified from voting, whether or not such member or members constitute a quorum, may unanimously appoint another member of the Board of Directors to act at the meeting in the place of any such absent or disqualified member. Any such committee, to the extent provided in the resolution of the Board of Directors and subject to the provisions of law, shall have and may exercise all the powers and authority of the Board of Directors in the management of the business and affairs of the corporation and may authorize the seal of the corporation to be affixed to all papers which may require it. Each such committee shall keep minutes and make such reports as the Board of Directors may from time to time request. Except as the Board of Directors may otherwise determine, any committee may make rules for the conduct of its business, but unless otherwise provided by the directors or in such rules, its business shall be conducted as nearly as possible in the same manner as is provided in these By-laws for the Board of Directors. Except as otherwise provided in the Certificate of Incorporation, these Bylaws, or the resolution of the Board of Directors designating the committee, a committee may create one or more subcommittees, each subcommittee to consist of one or more members of the committee, and delegate to a subcommittee any or all of the powers and authority of the committee.

2.15 Compensation of Directors . Directors may be paid such compensation for their services and such reimbursement for expenses of attendance at meetings as the Board of Directors may from time to time determine. No such payment shall preclude any director from serving the corporation or any of its parent or subsidiary entities in any other capacity and receiving compensation for such service.

ARTICLE III

OFFICERS

3.1 Titles . The officers of the corporation shall consist of a Chief Executive Officer, a President, a Secretary, a Treasurer and such other officers with such other titles as the Board of Directors shall determine, including a Chairman of the Board, a Vice Chairman of the Board, and one or more Vice Presidents, Assistant Treasurers, and Assistant Secretaries. The Board of Directors may appoint such other officers as it may deem appropriate.

3.2 Election . The Chief Executive Officer, President, Treasurer and Secretary shall be elected annually by the Board of Directors at its first meeting following the annual meeting of stockholders. Other officers may be appointed by the Board of Directors at such meeting or at any other meeting.

3.3 Qualification . No officer need be a stockholder. Any two or more offices may be held by the same person.

 

10


3.4 Tenure . Except as otherwise provided by law, by the Certificate of Incorporation or by these By-laws, each officer shall hold office until such officer’s successor is elected and qualified, unless a different term is specified in the resolution electing or appointing such officer, or until such officer’s earlier death, resignation or removal.

3.5 Resignation and Removal . Any officer may resign by delivering a written resignation to the corporation at its principal office or to the Chief Executive Officer, the President or the Secretary. Such resignation shall be effective upon receipt unless it is specified to be effective at some later time or upon the happening of some later event.

Any officer may be removed at any time, with or without cause, by vote of a majority of the directors then in office.

Except as the Board of Directors may otherwise determine, no officer who resigns or is removed shall have any right to any compensation as an officer for any period following such officer’s resignation or removal, or any right to damages on account of such removal, whether such officer’s compensation be by the month or by the year or otherwise, unless such compensation is expressly provided for in a duly authorized written agreement with the corporation.

3.6 Vacancies . The Board of Directors may fill any vacancy occurring in any office for any reason and may, in its discretion, leave unfilled for such period as it may determine any offices other than those of Chief Executive Officer, President, Treasurer and Secretary. Each such successor shall hold office for the unexpired term of such officer’s predecessor and until a successor is elected and qualified, or until such officer’s earlier death, resignation or removal.

3.7 Chairman of the Board . The Board of Directors may appoint from its members a Chairman of the Board, who need not be an employee or officer of the corporation. If the Board of Directors appoints a Chairman of the Board, such Chairman shall perform such duties and possess such powers as are assigned by the Board of Directors and, if the Chairman of the Board is also designated as the corporation’s Chief Executive Officer, shall have the powers and duties of the Chief Executive Officer prescribed in Section 3.8 of these By-laws. Unless otherwise provided by the Board of Directors, the Chairman of the Board shall preside at all meetings of the Board of Directors and stockholders.

3.8 President; Chief Executive Officer . Unless the Board of Directors has designated the Chairman of the Board or another person as the corporation’s Chief Executive Officer, the President shall be the Chief Executive Officer of the corporation. The Chief Executive Officer shall have general charge and supervision of the business of the Corporation subject to the direction of the Board of Directors. The President shall perform such other duties and shall have such other powers as the Board of Directors or the Chief Executive Officer (if the President is not the Chief Executive Officer) may from time to time prescribe. In the event of the absence, inability or refusal to act of the Chief Executive Officer or the President (if the President is not the Chief Executive Officer), the Vice President (or if there shall be more than one, the Vice Presidents in the order determined by the Board of Directors) shall perform the duties of the Chief Executive Officer and when so performing such duties shall have all the powers of and be subject to all the restrictions upon the Chief Executive Officer.

 

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3.9 Vice Presidents . Any Vice President shall perform such duties and possess such powers as the Board of Directors or the Chief Executive Officer may from time to time prescribe. The Board of Directors may assign to any Vice President the title of Executive Vice President, Senior Vice President or any other title selected by the Board of Directors.

3.10 Secretary and Assistant Secretaries . The Secretary shall perform such duties and shall have such powers as the Board of Directors or the Chief Executive Officer may from time to time prescribe. In addition, the Secretary shall perform such duties and have such powers as are incident to the office of the secretary, including without limitation the duty and power to give notices of all meetings of stockholders and special meetings of the Board of Directors, to attend all meetings of stockholders and the Board of Directors and keep a record of the proceedings, to maintain a stock ledger and prepare lists of stockholders and their addresses as required, to be custodian of corporate records and the corporate seal and to affix and attest to the same on documents.

Any Assistant Secretary shall perform such duties and possess such powers as the Board of Directors, the Chief Executive Officer or the Secretary may from time to time prescribe. In the event of the absence, inability or refusal to act of the Secretary, the Assistant Secretary (or if there shall be more than one, the Assistant Secretaries in the order determined by the Board of Directors) shall perform the duties and exercise the powers of the Secretary.

In the absence of the Secretary or any Assistant Secretary at any meeting of stockholders or directors, the chairman of the meeting shall designate a temporary secretary to keep a record of the meeting.

3.11 Treasurer and Assistant Treasurers . The Treasurer shall perform such duties and shall have such powers as may from time to time be assigned by the Board of Directors or the Chief Executive Officer. In addition, the Treasurer shall perform such duties and have such powers as are incident to the office of treasurer, including without limitation the duty and power to keep and be responsible for all funds and securities of the corporation, to deposit funds of the corporation in depositories selected in accordance with these By-laws, to disburse such funds as ordered by the Board of Directors, to make proper accounts of such funds, and to render as required by the Board of Directors statements of all such transactions and of the financial condition of the corporation.

The Assistant Treasurers shall perform such duties and possess such powers as the Board of Directors, the Chief Executive Officer or the Treasurer may from time to time prescribe. In the event of the absence, inability or refusal to act of the Treasurer, the Assistant Treasurer (or if there shall be more than one, the Assistant Treasurers in the order determined by the Board of Directors) shall perform the duties and exercise the powers of the Treasurer.

3.12 Salaries . Officers of the corporation shall be entitled to such salaries, compensation or reimbursement as shall be fixed or allowed from time to time by the Board of Directors.

 

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ARTICLE IV

CAPITAL STOCK

4.1 Issuance of Stock . Subject to the provisions of the Certificate of Incorporation, the whole or any part of any unissued balance of the authorized capital stock of the corporation or the whole or any part of any shares of the authorized capital stock of the corporation held in the corporation’s treasury may be issued, sold, transferred or otherwise disposed of by vote of the Board of Directors in such manner, for such lawful consideration and on such terms as the Board of Directors may determine.

4.2 Certificates of Stock . Every holder of stock of the corporation shall be entitled to have a certificate, in such form as may be prescribed by law and by the Board of Directors, certifying the number and class of shares owned by such holder in the corporation. Each such certificate shall be signed by, or in the name of the corporation by, the Chairman or Vice Chairman, if any, of the Board of Directors, or the President or a Vice President, and the Treasurer or an Assistant Treasurer, or the Secretary or an Assistant Secretary of the corporation. Any or all of the signatures on the certificate may be a facsimile.

Each certificate for shares of stock which are subject to any restriction on transfer pursuant to the Certificate of Incorporation, these By-laws, applicable securities laws or any agreement among any number of stockholders or among such holders and the corporation shall have conspicuously noted on the face or back of the certificate either the full text of the restriction or a statement of the existence of such restriction.

There shall be set forth on the face or back of each certificate representing shares of such class or series of stock of the corporation a statement that the corporation will furnish without charge to each stockholder who so requests a copy of the full text of the powers, designations, preferences and relative, participating, optional or other special rights of each class of stock or series thereof and the qualifications, limitations or restrictions of such preferences and/or rights.

4.3 Transfers . Except as otherwise established by rules and regulations adopted by the Board of Directors, and subject to applicable law, shares of stock may be transferred on the books of the corporation by the surrender to the corporation or its transfer agent of the certificate representing such shares properly endorsed or accompanied by a written assignment or power of attorney properly executed, and with such proof of authority or the authenticity of signature as the corporation or its transfer agent may reasonably require. Except as may be otherwise required by law, by the Certificate of Incorporation or by these By-laws, the corporation shall be entitled to treat the record holder of stock as shown on its books as the owner of such stock for all purposes, including the payment of dividends and the right to vote with respect to such stock, regardless of any transfer, pledge or other disposition of such stock until the shares have been transferred on the books of the corporation in accordance with the requirements of these By-laws.

4.4 Lost, Stolen or Destroyed Certificates . The corporation may issue a new certificate of stock in place of any previously issued certificate alleged to have been lost, stolen or destroyed, upon such terms and conditions as the Board of Directors may prescribe, including

 

13


the presentation of reasonable evidence of such loss, theft or destruction and the giving of such indemnity and posting of such bond as the Board of Directors may require for the protection of the corporation or any transfer agent or registrar.

4.5 Record Date . The Board of Directors may fix in advance a date as a record date for the determination of the stockholders entitled to notice of or to vote at any meeting of stockholders, or entitled to receive payment of any dividend or other distribution or allotment of any rights in respect of any change, conversion or exchange of stock, or for the purpose of any other lawful action. Such record date shall not be more than 60 nor less than 10 days before the date of such meeting, nor more than 60 days prior to any other action to which such record date relates.

If no record date is fixed, the record date for determining stockholders entitled to notice of or to vote at a meeting of stockholders shall be at the close of business on the day before the day on which notice is given, or, if notice is waived, at the close of business on the day before the day on which the meeting is held. If no record date is fixed, the record date for determining stockholders for any other purpose shall be at the close of business on the day on which the Board of Directors adopts the resolution relating to such purpose.

A determination of stockholders of record entitled to notice of or to vote at a meeting of stockholders shall apply to any adjournment of the meeting; provided, however, that the Board of Directors may fix a new record date for the adjourned meeting.

ARTICLE V

GENERAL PROVISIONS

5.1 Fiscal Year . Except as from time to time otherwise designated by the Board of Directors, the fiscal year of the corporation shall begin on the first day of January of each year and end on the last day of December in each year.

5.2 Corporate Seal . The corporate seal shall be in such form as shall be approved by the Board of Directors.

5.3 Waiver of Notice . Whenever notice is required to be given by law, by the Certificate of Incorporation or by these By-laws, a written waiver signed by the person entitled to notice, or a waiver by electronic transmission by the person entitled to notice, whether before, at or after the time stated in such notice, shall be deemed equivalent to notice. Attendance of a person at a meeting shall constitute a waiver of notice of such meeting, except when the person attends a meeting for the express purpose of objecting at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened.

5.4 Voting of Securities . Except as the Board of Directors may otherwise designate, the Chief Executive Officer, the President or the Treasurer may waive notice of, and act as, or appoint any person or persons to act as, proxy or attorney-in-fact for this corporation (with or without power of substitution) at any meeting of stockholders or securityholders of any other entity, the securities of which may be held by this corporation.

 

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5.5 Evidence of Authority . A certificate by the Secretary, or an Assistant Secretary, or a temporary Secretary, as to any action taken by the stockholders, directors, a committee or any officer or representative of the corporation shall as to all persons who rely on the certificate in good faith be conclusive evidence of such action.

5.6 Certificate of Incorporation . All references in these By-laws to the Certificate of Incorporation shall be deemed to refer to the Certificate of Incorporation of the corporation, as amended and in effect from time to time.

5.7 Severability . Any determination that any provision of these By-laws is for any reason inapplicable, illegal or ineffective shall not affect or invalidate any other provision of these By-laws.

5.8 Pronouns . All pronouns used in these By-laws shall be deemed to refer to the masculine, feminine or neuter, singular or plural, as the identity of the person or persons may require.

ARTICLE VI

AMENDMENTS

These By-laws may be altered, amended or repealed, in whole or in part, or new By-laws may be adopted by the Board of Directors or by the stockholders as provided in the Certificate of Incorporation.

 

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Exhibit 4.1

 

Common Stock     Common Stock

Certificate

Number

    Shares

[Achillion logo]

ACHILLION PHARMACEUTICALS, INC.

INCORPORATED UNDER THE LAWS OF THE STATE OF DELAWARE

CUSIP 00448Q 20 1

SEE REVERSE SIDE FOR CERTAIN DEFINITIONS

THIS CERTIFIES THAT

is the owner of

FULLY PAID AND NON-ASSESSABLE SHARES OF COMMON STOCK OF

Achillion Pharmaceuticals, Inc. (hereinafter called the “Company”) transferable on the books of the Corporation by the holder hereof, in person or by duly authorized attorney, upon surrender of this Certificate properly endorsed. This Certificate is not valid until countersigned and registered by the Transfer Agent and Registrar.

Witness the facsimile seal of the Corporation and facsimile signatures of its duly authorized officers.

Dated:

 

/s/ Michael D. Kishbauch

  [Seal]  

/s/ Mary Kay Fenton

President, Chief Executive Officer and

Director

    Vice President and Chief Financial Officer

 

COUNTERSIGNED AND REGISTERED:
Computershare Trust Company, N.A.
Transfer Agent and Registrar
By:  

 

  Authorized Signature


Achillion Pharmaceuticals, INC.

The following abbreviations, when used in the inscription on the face of this certificate, shall be construed as though they were written out in full according to applicable laws or regulations:

 

TEN COM

 

-

 

as tenants in common

  

UNIF GIFT MIN ACT -

                                    Custodian                             
          (Cust)                                    (Minor)     

TEN ENT

 

-

 

as tenants by the entireties

     

under Uniform Gifts to Minors Act                     

                                                         (State)

JT TEN

 

-

 

as joint tenants with right of

survivorship and not as

tenants in common

  

UNIF TRF MIN ACT -

  

                                 Custodian (until age              )

(Cust)                             (Minor)

         

under Uniform Transfers to Minors Act                 

                                                             (State)

Additional abbreviations may also be used though not in the above list.

THE COMPANY WILL FURNISH WITHOUT CHARGE TO EACH SHAREHOLDER WHO SO REQUESTS, A SUMMARY OF THE POWERS, DESIGNATIONS, PREFERENCES AND RELATIVE, PARTICIPATING OPTIONAL OR OTHER SPECIAL RIGHTS OF EACH CLASS OF STOCK OF THE COMPANY AND THE QUALIFICATIONS, LIMITATIONS OR RESTRICTIONS OF SUCH PREFERENCES AND RIGHTS, AND THE VARIATIONS IN RIGHTS, PREFERENCES AND LIMITATIONS DETERMINED FOR EACH SERIES, WHICH ARE FIXED BY THE ARTICLES OF INCORPORATION OF THE COMPANY, AS AMENDED, AND THE RESOLUTIONS OF THE BOARD OF DIRECTORS OF THE COMPANY, AND THE AUTHORITY OF THE BOARD OF DIRECTORS TO DETERMINE VARIATIONS FOR FUTURE SERIES. SUCH REQUEST MAY BE MADE TO THE OFFICE OF THE SECRETARY OF THE COMPANY OR TO THE TRANSFER AGENT. THE BOARD OF DIRECTORS MAY REQUIRE THE OWNER OF A LOST OR DESTROYED STOCK CERTIFICATE, OR HIS LEGAL REPRESENTATIVES, TO GIVE THE COMPANY A BOND TO INDEMNIFY IT AND ITS TRANSFER AGENTS AND REGISTRARS AGAINST ANY CLAIM THAT MAY BE MADE AGAINST THEM ON ACCOUNT OF THE ALLEGED LOSS OR DESTRUCTION OF ANY SUCH CERTIFICATE.

PLEASE INSERT SOCIAL SECURITY OR OTHER

IDENTIFYING NUMBER OF ASSIGNEE

 

For value received,                      hereby sell, assign and transfer unto         

______________________________________________________________________________________________________________________________

            (PLEASE PRINT OR TYPEWRITE NAME AND ADDRESS, INCLUDING ZIP CODE, OF ASSIGNEE)

______________________________________________________________________________________________________________________________

______________________________________________________________________________________________________________________________

_____________________________________________________________________________________________________Shares of the capital stock represented by the within Certificate, and do hereby irrevocably constitute and appoint

____________________________________________________________________________________________________Attorney to transfer the said stock on the books of the within named Corporation with full power of substitution in the premises.

 

Dated                      20     

     

Signature(s) Guaranteed: Medallion Guarantee Stamp

 

THE SIGNATURE(s) SHOULD BE GUARANTEED BY AN ELIGIBLE GUARANTOR INSTITUTION (Banks, Stockbrokers, Savings and Loan Associations and Credit Untions) WITH MEMBERSHIP IN AN APPROVED SIGNATURE GUARANTEE MEDALLION PROGRAM PURSUANT TO S.E.C. Rule 17Ad-15

Signature:

 

  

 

 

     

Signature:

 

  

 

 

     
          
             
             
             
             
             
             
             

Exhibit 5.1

LOGO

LOGO

September 21, 2006

Achillion Pharmaceuticals, Inc.

300 George Street

New Haven, CT 06511

 

Re: Registration Statement on Form S-1

Ladies and Gentlemen:

This opinion is furnished to you in connection with a Registration Statement on Form S-1 (File No. 333-132921) (the “Registration Statement”) filed with the Securities and Exchange Commission (the “Commission”) under the Securities Act of 1933, as amended (the “Securities Act”), for the registration of 5,175,000 shares of Common Stock, $.001 par value per share (the “Shares”), of Achillion Pharmaceuticals, Inc., a Delaware corporation (the “Company”), including 675,000 Shares issuable upon exercise of an over-allotment option granted by the Company.

The Shares are to be sold by the Company pursuant to an underwriting agreement (the “Underwriting Agreement”) to be entered into by and among the Company and Cowen & Co., LLC, CIBC World Markets Corp. and JMP Securities LLC, as representatives of the several underwriters named in the Underwriting Agreement, the form of which has been filed as Exhibit 1.1 to the Registration Statement.

We are acting as counsel for the Company in connection with the issue and sale by the Company of the Shares. We have examined signed copies of the Registration Statement as filed with the Commission. We have also examined and relied upon the Underwriting Agreement, minutes of meetings of the stockholders and the Board of Directors of the Company as provided to us by the Company, stock record books of the Company as provided to us by the Company, the Certificate of Incorporation and By-Laws of the Company, each as restated and/or amended to date, and such other documents as we have deemed necessary for purposes of rendering the opinions hereinafter set forth.

In our examination of the foregoing documents, we have assumed the genuineness of all signatures, the authenticity of all documents submitted to us as originals, the conformity to original documents of all documents submitted to us as copies, the authenticity of the originals of such latter documents and the legal competence of all signatories to such documents.

We express no opinion herein as to the laws of any state or jurisdiction other than the state laws of the Commonwealth of Massachusetts, the General Corporation Law of the State of Delaware and the federal laws of the United States of America.


Based upon and subject to the foregoing, we are of the opinion that the Shares have been duly authorized for issuance and, when the Shares are issued and paid for in accordance with the terms and conditions of the Underwriting Agreement, the Shares will be validly issued, fully paid and nonassessable.

Please note that we are opining only as to the matters expressly set forth herein, and no opinion should be inferred as to any other matters. This opinion is based upon currently existing statutes, rules, regulations and judicial decisions, and we disclaim any obligation to advise you of any change in any of these sources of law or subsequent legal or factual developments which might affect any matters or opinions set forth herein.

We hereby consent to the filing of this opinion with the Commission as an exhibit to the Registration Statement in accordance with the requirements of Item 601(b)(5) of Regulation S-K under the Securities Act and to the use of our name therein and in the related Prospectus under the caption “Legal Matters.” In giving such consent, we do not hereby admit that we are in the category of persons whose consent is required under Section 7 of the Securities Act or the rules and regulations of the Commission.

 

Very truly yours,

WILMER CUTLER PICKERING

HALE AND DORR LLP

By:

 

/s/    Steven D. Singer

 

Steven D. Singer, a Partner

Exhibit 10.1

 

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisks denote omissions.

 

RESEARCH COLLABORATION AND LICENSE AGREEMENT

 

THIS RESEARCH COLLABORATION AND LICENSE AGREEMENT ( “Agreement” ) is made effective as of November 24, 2004 ( “Effective Date” ) by and between ACHILLION PHARMACEUTICALS, INC., a Delaware corporation ( “Achillion” ), with its principal place of business at 300 George Street, New Haven, Connecticut 06511, USA, and GILEAD SCIENCES, INC., a Delaware corporation ( “Gilead” ), with its principal place of business at 333 Lakeside Drive, Foster City, California 94404, USA. Achillion and Gilead are sometimes referred to in this Agreement individually as a “Party” and collectively as the “Parties” .

 

RECITALS

 

WHEREAS , Achillion has certain proprietary technology in compounds for the prevention and treatment of chronic hepatitis C infection;

 

WHEREAS , Gilead and Achillion desire to enter into a collaboration to develop and commercialize Compounds (as hereinafter defined) upon the terms and conditions set forth herein;

 

WHEREAS , Gilead desires to obtain the right to develop and commercialize Licensed Products in the Field (each as hereinafter defined) and Achillion desires to grant such rights, in each case upon the terms and conditions set forth herein.

 

NOW, THEREFORE , in consideration of the foregoing premises and the mutual covenants herein contained, the Parties hereby agree as follows:

 

AGREEMENT

 

1. DEFINITIONS

 

Unless specifically set forth to the contrary herein, the following terms, whether used in the singular or plural, shall have the respective meanings set forth below. References to “Articles”, “Sections” and “subsections” in this Agreement shall be to Articles, Sections and subsections respectively, of this Agreement unless otherwise specifically provided:

 

“Achillion Annual Budget Amount” means the Annual Budget Amount allotted to Achillion in the Budget.

 

“Achillion Know-How” means Know-How Controlled by Achillion (a) as of the Effective Date; (b) that is developed or acquired in the course of the Research Program; or (c)


that is developed or acquired outside of the course of the Research Program that is necessary or useful to the research, Development, manufacture, use, sale, offer for sale, or importation of Compounds.

 

“Achillion Patents” means Patents Controlled by Achillion (a) that are listed in Exhibit 1.1; (b) as of the Effective Date; (c) that are conceived, reduced to practice or acquired in the course of the Research Program; or (d) that claim or are directed to the research, Development, manufacture, use, sale, offer for sale or importation of Compounds. The Patents listed in Exhibit 1.1 shall be amended or supplemented from time to time by Achillion to include any Patent Controlled by Achillion after the Effective Date and during the Research Program Term which claims or is directed to a composition of matter, or the manufacture or use thereof, that is necessary or useful to the research, Development, manufacture, use, sale, offer for sale or importation of Compounds.

 

“Achillion Research Costs” means Research Costs incurred by Achillion.

 

“Achillion Technology” means Achillion Patents and Achillion Know-How.

 

“ADR” has the meaning given such term in Section 12.1(b).

 

“ADR Request” has the meaning given such term in Section 12.1(b)(i).

 

“Affiliate” means any corporation or other entity which has Corporate Control of, is under Corporate Control by, or is under common Corporate Control with, a Party to this Agreement. An entity shall be an Affiliate of a Party for only so long as such Corporate Control exists.

 

“Annual Budget Amount” means the Research Costs for both Parties reflected in the Budget for each calendar year in accordance with Section 2.4.

 

“Arbitration Panel” has the meaning given in Section 12.1(c)(i).

 

“Back-up Compound” means any Compound other than the Lead Compound.

 

“Back-up Program” means the component of the Research Program devoted to Back-up Compounds.

 

“Blackout Period” means the period beginning on the Effective Date, and ending on the earlier of (a) Proof of Concept; or (b) the second anniversary of the Effective Date.

 

“Budget” has the meaning given such term in Section 2.4(a)(i).

 

“Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31.

 

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“Change of Corporate Control” means, with respect to a Party, the occurrence of any of the following:

 

(a) any consolidation or merger of a Party with or into any Third Party, or any other corporate reorganization involving a Third Party ( “Merger” ), as long as the stockholders of such Party immediately prior to the Merger own less than fifty percent (50%) of the surviving entity’s voting power immediately after the Merger;

 

(b) a change in the beneficial ownership of fifty percent (50%) or more of the voting securities of any Party (whether in a single transaction or series of related transactions) where, immediately after giving effect to such change, the legal or beneficial owner of more than fifty percent (50%) of the voting securities of such Party is a Third Party, excluding any equity investments by venture capitalists or investment banks or other non-strategic investors, who alone or with their Affiliates, are not themselves in the business of developing and commercializing pharmaceutical products; or

 

(c) the sale, transfer, lease, license or other disposition to a Third Party of all or substantially all of a Party’s assets in one or a series of related transactions.

 

As used in this definition, “Party” shall exclude Affiliates under Corporate Control by, or under common Corporate Control with, such Party.

 

“CMC” has the meaning given to such term in Section 4.1.

 

“Combination Product” means a product that includes one or more pharmaceutically active ingredients other than a Compound in combination with at least one Compound. All references to Licensed Product in this Agreement shall be deemed to include a Combination Product.

 

“Commercially Diligent Efforts” mean those efforts to research, Develop, commercialize and market Licensed Products that are consistent with the usual practice followed by pharmaceutical companies in pursuing the research, Development, commercialization and marketing of their pharmaceutical products with a comparable potential market, risk, and revenues.

 

“Compound” has the meaning given in Exhibit 1.2.

 

“Confidential Information” has the meaning given such term in Section 7.1(a).

 

“Control”, “Controls” and “Controlled” mean, with respect to a particular item of information or intellectual property right, that the applicable Party owns or has a license to such item or right and has the ability to grant to the other Party access to and a license or sublicense (as applicable) under such item or rights as provided for herein without violating the terms of any agreement or other arrangement with any Third Party existing as of the Effective Date or thereafter.

 

“Corporate Control” means (a) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares having the right to vote for the election of directors, and (b) in the case of non-corporate entities, direct or indirect ownership of at least fifty percent (50%) of the equity interest with the power to direct the management and policies of such non-corporate entities.

 

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“Develop” means the conduct of any pre-clinical, clinical or other studies required for obtaining Regulatory Approval (including without limitation manufacturing, formulation, quality assurance and quality control activities) or for commercialization of a Compound, along with any other clinical studies, all in accordance with this Agreement. The terms “Developing” and “Development” shall be interpreted accordingly.

 

“Development Committee” has the meaning given such term in Section 3.1(a).

 

“Development Plan” has the meaning given such term in Section 3.2.

 

“Development Program Term” means the period commencing when Proof of Concept is established and ending upon receipt of Regulatory Approvals from both the FDA and the EMEA.

 

“Discover” means the identification and optimization of the preclinical properties of Compounds. The terms “Discovering” and “Discovery” shall be interpreted accordingly.

 

“Drug Approval Application” shall mean an application for Regulatory Approval of a Licensed Product, including without limitation an IND or NDA.

 

“EMEA” means the European Medicines Agency, or a successor agency thereto.

 

“European Market” means Germany, France, Italy, Spain and the United Kingdom.

 

“External Research Costs” means the reasonable and actual out-of-pocket costs, approved in advance by the Research Committee and reflected in the Budget, incurred by a Party from a Third Party, without mark-up or overhead charges, directly in furtherance of the Research Program. Examples of External Research Costs that could be approved by the Research Committee are the costs charged by Third Parties for materials to make Compounds, contract researchers and/or toxicology studies. “External Research Costs” shall not include any costs reflected in the FTE Rate.

 

“FDA” means the United States Food and Drug Administration, or a successor federal agency thereto.

 

“Field” means all human and animal therapeutic, diagnostic, and prophylactic uses, including, without limitation, the treatment, prevention and prophylaxis of hepatitis C viral infections.

 

“Field-Based Personnel” has the meaning given such term in Section 4.2(b)(i).

 

“First Commercial Sale” means, with respect to any Licensed Product, the first sale for end use or consumption of such Licensed Product in a Major Market after all required Regulatory Approvals with respect to such Licensed Product have been granted by the Regulatory Authority of such Major Market. For purposes of clarification, the first sale for end use or consumption of a Licensed Product in a Major Market after conditional approval has been granted will constitute a First Commercial Sale for purposes of this Agreement.

 

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“FTE” means an annualized full-time employee or equivalent, working no less than 1800 person hours per calendar year, with part-time personnel pro-rated as partial FTE’s.

 

“FTE Rate” means the amount a Party will pay the other Party over a consecutive twelve (12) month period for one (1) FTE. Unless otherwise agreed by the Parties:

 

(a) for Achillion FTEs conducting scientific research activities for Gilead pursuant to the Research Program, the FTE Rate will be [**] Dollars ($[**]), with an annual cost of living adjustment (commencing January 1, 2006) in accordance with CPI-U as published by the Department of Labor Bureau of Labor Statistics; and

 

(b) for FTEs employed by the Parties and identified in the Research Plan and Budget as conducting activities in furtherance of the Research Program (other than activities conducted pursuant to subparagraph (a) above), the FTE Rate will be [**] Dollars ($[**]), with an annual cost of living adjustment (commencing January 1, 2006) in accordance with CPI-U as published by the Department of Labor Bureau of Labor Statistics.

 

The FTE Rate shall reflect, and include, all personnel costs (including normal vacations, sick days, holidays and employee benefits), and costs of equipment, reagents, travel, materials and supplies, allocation of general and administrative expenses, repairs, maintenance, utilities, rent, support staff and other overhead, for or associated with an FTE, provided that payment by a Party of the FTE Rate shall not be deemed to give such Party any ownership interest in any equipment, reagents or other property purchased by the other Party using such research funding.

 

“GAAP” means United States Generally Acceptable Accounting Principles.

 

“Gilead Annual Budget Amount” means the Annual Budget Amount allotted to Gilead in the Budget.

 

“Gilead Know-How” means Know-How Controlled by Gilead that is necessary or useful to the research, Development, manufacture, use, sale, offer for sale, or importation of Compounds.

 

“Gilead Patents” means any Patent Controlled by Gilead that is necessary or useful to the research, Development, manufacture, use, sale, offer for sale, or importation of Compounds.

 

“Gilead Research Costs” means Research Costs incurred by Gilead.

 

“Gilead Technology” means Gilead Patents and Gilead Know-How.

 

“HCV Field” means the treatment of chronic hepatitis C viral infections in humans.

 

“IND” means an Investigational New Drug application, Clinical Study Application, Clinical Trial Exemption, or similar application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority.

 

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“Information” means any and all information, data, results, inventions, trade secrets, techniques, material, or compositions of matter of any type or kind, including without limitation all know-how and all other scientific, pre-clinical, clinical, regulatory, manufacturing, marketing, personnel, financial, legal and commercial information or data, whether communicated in writing, orally or by any other method, which is disclosed by one Party to the other Party in connection with this Agreement; provided that the foregoing is related to a Compound.

 

“Invention” means any process, method, use, composition of matter, article of manufacture, discovery or finding, whether or not patentable.

 

“Joint Inventions” has the meaning given such term in Section 9.1.

 

“Joint Patents” has the meaning given such term in Section 9.1.

 

“Know-How” means all tangible and intangible (a) techniques, technology, practices, trade secrets, inventions (whether patentable or not), methods, knowledge, know-how, skill, experience, test data and results (including pharmacological, toxicological and clinical test data and results), analytical and quality control data, results or descriptions, software and algorithms and (b) compounds, compositions of matter, cells, cell lines, assays, animal models and physical, biological or chemical material Controlled by Party or its Affiliates, in either case that are necessary or useful to the research, Development, formulation, manufacture, use or sale of Compounds.

 

“Lead Compound” has the meaning given such term in Section 2.2(a)(iv).

 

“Licensed Product” means any preparations in final form, bulk form or other form containing as an active pharmaceutical ingredient one or more Compounds for sale by prescription, over-the-counter or any other method, including without limitation any Combination Product.

 

“Major Market” means each of the United States of America, Japan and each of the five (5) countries of the European Market.

 

“NDA” means a New Drug Application, Biologics License Application, Worldwide Marketing Application, Regulatory Approval application or similar application or submission for Regulatory Approval of a Licensed Product filed with a Regulatory Authority to obtain marketing approval for a biological or pharmaceutical product in that country or in that group of countries.

 

“Net Difference” has the meaning give such term in Section 2.4(c)(iii).

 

“Net Sales” means, with respect to a given period of time, the total amount invoiced by Gilead or its Related Gilead Parties for sales of Licensed Products to a Third Party (whether an end-user, wholesaler or otherwise) in the Territory, less the following deductions with respect to such sale, to the extent applicable to the Licensed Product and to the extent actually allowed and/or taken: (a) trade, cash and quantity credits, discounts, credits, and refunds, (b) allowances or credits for returns or rejected Licensed Product and a reasonable allowance for bad debt expense consistent with GAAP; (c) prepaid freight and insurance; (d) sales taxes and other

 

6


governmental charges (including value added and similar taxes, but solely to the extent not otherwise creditable or reimbursed and excluding any income tax) actually paid by Gilead or its Related Gilead Parties in connection with the sale; and (e) customary rebates (including, for this purpose, discounts provided by means of chargebacks or rebates) actually granted to managed health care organizations, federal, state, or local governments (or their agencies) (including without limitation Medicaid rebates), all to the extent in accordance with GAAP as consistently applied across all products of Gilead.

 

Where Licensed Product is sold in the form of a Combination Product containing one or more active pharmaceutical ingredients ( “API” ) in addition to a Compound, the Net Sales for such Combination Product for purposes of determining royalties payable under this Agreement will be calculated by multiplying the Net Sales of such Combination Product (without regard to the adjustment established by this paragraph) by the fraction A/(A+B) where A is the Net Selling Price for the stock keeping unit most comparable to the component of the Licensed Product containing that Compound as the sole API, if sold separately, in such country during the relevant fiscal quarter (or if not available in that quarter, the most recent available fiscal quarter), and B is the Net Selling Price for the stock keeping unit, most comparable to the component containing other APIs, if sold separately, in such country during the relevant fiscal quarter. For clarity, if there are three or more APIs (including the Compound), additional B terms calculated in the same manner, shall be included in the denominator so that such fraction shall be A/(A+B1+B2+…).

 

If, on a country-by-country basis, one or more of the other APIs in the Combination Product are not sold separately in said country, the Net Sales for the purpose of determining royalties payable under this Agreement for the Combination Product shall be calculated by multiplying the Net Sales of such Combination Product (without regard to the adjustment established by this paragraph) by the fraction A/C where A is the Net Selling Price for the stock keeping unit most comparable to the component of the Licensed Product containing the relevant Compound as the sole API, if sold separately, in such country during the relevant fiscal quarter (or if not available in that quarter, the most recent available fiscal quarter) and C is the Net Selling Price for the Combination Product in such country during the relevant fiscal quarter (or if not available in that quarter, the most recent available fiscal quarter).

 

If, on a country-by-country basis, the Licensed Product containing a Compound as the sole API is not sold separately in said country during the relevant fiscal quarter but one or more of the other APIs in the Combination Product are sold separately in said country during the relevant fiscal quarter (or if not available in that quarter, the most recent available fiscal quarter), the Net Sales for the Combination Product shall be calculated by multiplying the Net Sales of such Combination Product (without regard to the adjustment established by this paragraph) by the fraction (1-(D/C)) where D is the Net Selling Price for the stock keeping unit most comparable to the product containing the other API as the sole API and C is the Net Selling Price for the Combination Product in such country during the relevant fiscal quarter (or if not available in that quarter, the most recent available fiscal quarter).

 

If, on a country-by-country basis, the Licensed Product containing a Compound as the sole API is not sold separately in a country and one or more of the other APIs in the Combination Product are not sold separately in such country, the Net Sales of the Combination

 

7


Product shall be deemed to be the Net Sales of such Combination Product (without regard to the adjustment established by this paragraph) multiplied by the fraction A/C where A is the Net Selling Price on an average worldwide basis for the stock keeping unit most comparable to the Licensed Product containing the relevant Compound as the sole API, and C is the Net Selling Price for the Combination Product on an average worldwide basis.

 

For clarification, sale of a Licensed Product by Gilead or its Related Gilead Parties to Gilead or Related Gilead Parties for resale by such entity to an unaffiliated Third Party shall not be deemed a sale for purposes of “Net Sales” hereunder, but the sale of such Licensed Product by such entity to an unaffiliated Third Party (whether an end-user, wholesaler, distributor, or otherwise) shall be deemed to be a sale by Gilead of a Licensed Product to a Third Party for purposes of calculating Net Sales hereunder and royalties owed by Gilead under Section 6.5. Further, transfers or dispositions of Licensed Products in commercially reasonable quantities (consistent with Gilead’s usual practice as applied to other compounds and products of a similar nature) and without receipt of compensation, or if sold on a not-for-profit basis for charitable or promotional purposes or for pre-clinical or clinical Development, manufacturing scale-up or regulatory purposes prior to receiving Regulatory Approval shall not be deemed “sales” for purposes of “Net Sales” hereunder.

 

If Gilead intends to sell a Combination Product in any country in the Territory where the Compound contained in the Licensed Product is not sold separately in such country, “Net Sales” for the Licensed Product shall be determined pursuant to Section 5.7.

 

“Net Selling Price” means the Net Sales (as defined in the first paragraph of the definition of “Net Sales”, without giving effect to the subsequent paragraphs of such definition) of a product divided by the number of units of product sold.

 

“New HCV Compound” means any compound (other than a Compound) that is useful to prevent or treat chronic hepatitis C viral infections in humans that as of the Effective Date is, or at any time during the term of this Agreement will be, under the Control of Achillion.

 

“Offer Notice” has the meaning given such term in Section 6.12(a).

 

“Offsetting IP” means:

 

(a) Know-How, Patents or information owned by a Third Party that is required for the research, Development, manufacture, use, sale, offer for sale or importation, of Compounds; and

 

(b) any other Third Party intellectual property rights, not included in clause (a), for which Gilead pays Third Party Royalties, provided that Achillion has consented to have such intellectual property rights included as Offsetting IP, with such consent not to be unreasonably withheld.

 

“Patent Costs” shall mean all reasonable and actual out-of-pocket costs incurred by a Party for work performed before and after the Effective Date associated with filing, prosecuting, issuing and maintaining Achillion Patents, including interference, opposition, reexamination and reissue actions; provided that the other Party shall prior to payment have the right to review and

 

8


comment on any such costs that exceed $[**] for any calendar month, and any amount reasonably objected to by such other Party shall not constitute Patent Costs.

 

“Patents” mean (a) all patents, certificates of invention, applications for certificates of invention, and patent applications, including without limitation patent applications under the Patent Cooperation Treaty and the European Patent Convention, provisional, non-provisional, and abandoned patent applications throughout the world, together with (b) any renewal, divisional, continuation (in whole or in part), or continued prosecution applications of any of such patents, certificates of invention and patent applications, and any and all patents or certificates of invention issuing thereon, and any and all reissues, reexaminations, extensions, divisional, renewals, substitutions, confirmations, supplemental protection certificates, registrations, revalidations, revisions, and additions of or to any of the foregoing, and any foreign counterparts of any of the foregoing and any other patents and patent applications claiming priority back to any of the foregoing.

 

“Phase 1 Clinical Trial” means a human clinical trial in any country to initially evaluate the safety and/or pharmacological or antigenic effect of a Licensed Product in humans or that would otherwise satisfy the requirements of 21 CFR § 312.21(a) or the equivalent laws, rules or regulations in the European Union or Japan.

 

“Phase 2 Clinical Trial” means a human clinical trial in any country to initially evaluate the effectiveness of a Licensed Product (whether as a primary or secondary endpoint) for a particular indication or indications in humans with the disease or indication under study or that would otherwise satisfy the requirements of 21 CFR § 312.21(b) or the equivalent laws, rules or regulations in the European Union or Japan.

 

“Phase 3 Clinical Trial” means a pivotal human clinical trial in any country the results of which could be used to establish safety and efficacy of a Licensed Product to support Regulatory Approval and as a basis for a NDA or that would otherwise satisfy the requirements of 21 CFR § 312.21(c) or the equivalent laws, rules or regulations in the European Union or Japan.

 

“Proof of Concept” has the meaning given such term in Exhibit 1.3.

 

“Proof of Concept Program” means the component of the Research Program devoted to the Lead Compound.

 

“Regulatory Approval” means all governmental approvals (including pricing and reimbursement approvals), product and/or establishment licenses, registrations or authorizations necessary for the manufacture, use, storage, import, export, transport and/or sale of a Licensed Product in a jurisdiction.

 

“Regulatory Authority” means any applicable government regulatory authority necessary to obtain approval to manufacture, market and sell a Licensed Product in the Territory, including the FDA in the United States and the EMEA in the European Market.

 

“Related Gilead Party” means Gilead’s sub-licensees (which term does not include distributors or Affiliates of Gilead) permitted under this Agreement outside the United States of

 

9


America and the European Market. Notwithstanding the foregoing, in no event shall Achillion be considered a Related Gilead Party.

 

“Related Gilead Party Royalties” means royalties paid by a Related Gilead Party to Gilead or its Affiliates for Net Sales of Licensed Products.

 

“Research Cost Cap” means the maximum amount, set forth in Section 2.4(b), (a) of Research Costs that the Parties are required to spend in total by both Parties in furtherance of the Research Program, and (b) for which the Parties may receive reimbursement pursuant to Section 2.4(c).

 

“Research Costs” means (a) the reasonable and actual personnel costs of a Party, determined at the FTE Rate, and (b) External Research Costs reasonably and actually incurred by such Party, in each case reasonably incurred in furtherance of the Research Program by or for the account of such Party after the Effective Date; provided that such costs are consistent with the Research Plan and the Budget, and are specifically attributable to the Development of Compounds. For purposes of clarity, costs for activities that advance the Research Program but are not required for obtaining Proof of Concept shall not be included under the Research Plan and the full amount of such costs shall be borne by Gilead.

 

“Research Committee” means the committee described in Section 2.1.

 

“Research Plan” has the meaning given such term in Section 2.2(a)(i).

 

“Research Program” means the research and development program for the Compounds described in Section 2.3.

 

“Research Program Term” has the meaning given such term in Section 2.3(c).

 

“Royalty Rights” has the meaning given such term in Section 6.12(a).

 

“Royalty Term” means, with respect to a Licensed Product, for each country in the Territory, the period of time commencing on the First Commercial Sale of such Licensed Product in any country and ending the later of (a) ten (10) years after the date of First Commercial Sale in such country, or (b) the expiration of the last Valid Patent Claim of an Achillion Patent or Joint Patent in such country. Upon expiration of the Royalty Term for a Licensed Product in a country, Gilead may thereafter continue to sell such Licensed Product in such country on a royalty-free basis.

 

“Sublicense Royalty” has the meaning given such term in Section 6.5(b).

 

“Third Party” means an entity other than Gilead and its Related Gilead Parties, and Achillion.

 

“Third Party Infringement Losses” has the meaning given such term in Section 11.1.

 

“Third Party Royalties” means up-front, milestone, royalty and any other similar payments paid by Gilead or any Related Gilead Party to any Third Party for Offsetting IP for the

 

10


development, manufacture, use sale, offer for sale, or importation of Compounds or Licensed Products.

 

“Territory” means all of the countries in the world, and their territories and possessions.

 

“Valid Patent Claim” means a claim of an issued and unexpired Patent, which has not been revoked or held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, and which is not appealable or has not been appealed within the time allowed for appeal, and which has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination or disclaimer, otherwise.

 

2. RESEARCH PROGRAM

 

2.1 Research Committee

 

(a) Formation and Duration. Within ten (10) days after the Effective Date, Achillion and Gilead shall establish the Research Committee ( “Research Committee” ). Except to the extent otherwise provided by mutual written agreement of the Parties, the Research Committee shall disband upon the later of Proof of Concept or expiration of the Research Program Term.

 

(b) Authority. For the duration of the Research Program Term, the Research Committee will oversee the Parties’ activities in furtherance of the Research Program as follows:

 

(i) The Research Committee will review and if necessary revise the Research Plan and the Budget, coordinate activities under the Research Plan, confer regarding the status of the Research Program, review relevant data, consider and advise on any technical issues that arise, set research priorities, review project milestones, advise on clinical and pre-clinical development, regulatory, and manufacturing matters and strategies, and review and advise on financial matters relating to the Research Program.

 

(ii) In no event shall the Research Committee have the right to (A) modify or amend the terms and conditions of this Agreement; (B) determine which personnel of a Party perform Research Program activities or act as such Party’s representatives on the Research Committee; or (C) determine any matter involving prosecution, defense or enforcement of Patents.

 

(c) Composition

 

(i) Gilead shall designate three (3) named representatives of Gilead and Achillion shall designate three (3) named representatives of Achillion. Each Party shall appoint its respective representatives to the Research Committee and, from time to time, may substitute one or more of its representatives.

 

(ii) Additional representatives or consultants of a Party may from time to time, with the consent of the other Party (with such consent not to be unreasonably withheld) attend Research Committee meetings, subject to such representative’s and/or consultant’s written

 

11


agreement to comply with the confidentiality and non-use obligations equivalent to those set forth in Section 7, and provided that such additional representatives shall have no vote.

 

(iii) The Research Committee may establish such working groups or sub-committees as it may choose from, time to time to accomplish its purposes.

 

(iv) Members of the Research Committee may also serve as members of the Development Committee.

 

(d) Governance

 

(i) The Research Committee shall be chaired by a representative of Gilead.

 

(ii) Decisions of the Research Committee shall be made by unanimous vote, with each Party’s representatives on the Research Committee collectively having one (1) vote.

 

(iii) In the event that the Research Committee cannot or does not, after good faith efforts, reach agreement on an issue, such issue shall be referred to the Executive Vice President of Research and development for Gilead and the Chief Executive Officer for Achillion. Such officers of the Parties shall meet promptly thereafter and shall negotiate in good faith to resolve such issue. If they cannot resolve such issue within [**] of commencing such negotiations, then the resolution and/or course of conduct shall be determined by Gilead.

 

(e) Meetings

 

(i) The Research Committee shall meet at least once each Calendar Quarter in accordance with a schedule established by mutual written agreement of the Parties, with the location for such meetings determined by agreement of the Parties.

 

(ii) Either Party may call for non-scheduled meetings of the Research Committee for good cause, which shall occur at mutually agreeable times.

 

(iii) The Research Committee upon mutual agreement may meet by means of teleconference, videoconference or other similar communications equipment.

 

(iv) No Research Committee meeting may be conducted unless at least two (2) representatives of each Party are participating.

 

(v) Each Party shall bear its own expenses related to the attendance at Research Committee meetings.

 

(f) Records. The Research Committee chair, or his/her designee, shall have responsibility for preparing minutes of each Research Committee meeting. Such minutes shall provide a description, in reasonable detail, of the Research Program progress to date, updates to the Budget, the discussions at the meeting, a list of any actions or determination approved by the Research Committee and any disagreements not resolved by the Research Committee. Such

 

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minutes shall be circulated to all members of the Research Committee within thirty (30) days following the Research Committee meeting.

 

2.2 Research Plan

 

(a) Content

 

(i) The Parties shall, within sixty (60) days of the Effective Date, agree on a plan ( “Research Plan” ), which shall be consistent with the Initial Research Plan attached as Exhibit 2.2 hereto.

 

(ii) The Research Plan will describe the Research Program. Such description shall include, among other things: project milestones; timelines; the tasks to be conducted by the Parties; responsibilities of the Parties, the resources to be made available by each Party during the Research Program Term, the number of Achillion FTEs to be utilized (which shall include [**] FTEs during the Research Program Term to work on the Back-up Program); the number of Gilead FTEs to be utilized; the Budget; matters relating to clinical and pre-clinical development, regulatory filings and manufacturing; and such other matters as the Research Committee considers appropriate.

 

(iii) In the event of any conflict between the Research Plan and this Agreement, this Agreement shall prevail.

 

(iv) The Research Plan will provide that the Parties will pursue Development of one Compound at any time as a lead Compound (a “Lead Compound” ), and will specify those activities to be included in the Proof of Concept Program.

 

(v) The Research Plan will provide for Development of one or more Back-up Compounds, and will specify those activities to be included in the Back-up Program.

 

(1) Back-up Compounds may be Developed by both Parties pursuant to the Back-up Program as specified by the Research Plan, by Achillion pursuant to Section 2.4(d), or by Gilead outside the Research Program, subject to the limitations of Section 2.4(d)(iv).

 

(2) The Research Committee may amend the Research Plan to provide for reduction or termination of further development of the Lead Compound in favor of one or more Back-up Compounds. Any election by the Research Committee to reduce or terminate further development of the Lead Compound in favor of development of a Back-up Compound shall be made on a commercially reasonable basis. If any Back-up Compound is so selected in favor of the Lead Compound, such Back-up Compound shall be designated by the Research Committee as the Lead Compound for purposes of this Agreement.

 

(b) Amendment. The Research Plan may be amended from time to time by the Research Committee. Notwithstanding anything in this Agreement to the contrary, no amendment to the Research Plan that would transfer to Gilead any responsibility or activity previously assigned to Achillion shall be made without Achillion’s consent; provided however,

 

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that such consent shall not be required for any such amendment that is necessitated by Achillion’s failure to perform such responsibility or activity in a satisfactory or timely manner.

 

2.3 Research Program

 

(a) Conduct of the Program

 

(i) The Research Program will be conducted by each Party pursuant to and consistent with the Research Plan.

 

(ii) Subject to the terms and conditions of this Agreement, each Party shall be responsible for managing and controlling their personnel and performing their respective tasks pursuant to the Research Plan.

 

(iii) Each Party shall conduct the Research Program in good scientific manner, and in compliance in all material respects with all requirements of applicable laws, rules and regulations.

 

(iv) Each Party shall use Commercially Diligent Efforts in the Research Program, including without limitation allocation of sufficient time, effort, equipment and facilities to the Research Program, and shall use personnel with sufficient skills and experience as are required to accomplish the Research Program in accordance with the terms of this Agreement and the Research Plan.

 

(v) Notwithstanding anything else to the contrary in this Agreement, all activities conducted under the Research Program shall continue only until expiration of the Research Program Term.

 

(b) Use of Third Parties. Achillion shall be entitled to utilize the services of Third Parties to perform Research Program activities only upon the prior written consent of Gilead (not to be unreasonably withheld) or as specifically set forth in the Research Plan. In the event that either Party utilizes the services of Third Parties to perform Research Program activities, such Party shall obtain the written agreement of each such Third Party, prior to the time such Third Party initiates work, to (A) assign ownership of Inventions related to Compounds made in the course of Research Program activities to such Party and (B) maintain confidentiality of any Research Program activities or Information, and any Confidential Information in accordance with Section 7.

 

(c) Research Program Term. The Research Plan will provide that the term of the Research Program ( “Research Program Term” ) will expire upon establishment of Proof of Concept in a Compound, unless the Parties otherwise agree in an amendment to the Research Plan, in which case the Research Program Term will expire on the date agreed by the Parties. If Gilead elects to utilize Achillion FTEs to perform additional research pursuant to Section 2.4(d), the Research Program Term will continue until at least the end of the period that Gilead so elects to have Achillion FTEs conduct such activities.

 

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2.4 Costs Incurred for the Research Program

 

(a) Budget

 

(i) The Research Plan shall include a budget ( “Budget” ), which shall specify the amount anticipated to be spent in each calendar year of the Research Program Term, for all research and development activities to be conducted in furtherance of the Research Program, broken into such categories as the Research Committee considers appropriate.

 

(ii) Any proposed amendment to the Budget may be submitted by either Party to the Research Committee for consideration. The Research Committee shall agree on any amendment to the Budget as an amendment to the Research Plan, in accordance with Section 2.1(d)(ii).

 

(b) Research Cost Cap. The Parties have agreed on a Research Cost Cap of [**] Dollars ($[**]). The amount of the Research Cost Cap may only be increased or decreased by written agreement of the Parties, signed by the Chief Executive Officer for Achillion and the Executive Vice President for Research and Development for Gilead.

 

(c) Reimbursement for Research Costs

 

(i) Fifty Percent (50%) of each Party’s Research Costs incurred between the Effective Date and the date Proof of Concept is established shall be reimbursed by the other Party to the extent allowed, and pursuant to the procedure set forth in, this Section 2.4(c).

 

(ii) Within [**] following the end of each Calendar Quarter during the Research Program Term, each Party will send a statement of the Research Costs incurred by such Party to the other Party (in such form and manner as the Parties shall agree from time to time); provided, however, that for any calendar year:

 

(1) Achillion shall not seek or obtain reimbursement for Research Costs that (A) would result in reimbursement to Achillion of a total amount in any calendar year that exceeds [**]% of the Achillion Annual Budget Amount; or (B) would result in total reimbursement for all Research Costs that would exceed the Research Cost Cap; and

 

(2) Gilead shall not seek or obtain reimbursement for Research Costs that (A) would result in reimbursement to Gilead in any calendar year of a total amount that exceeds [**]% of the Gilead Annual Budget Amount; or (B) would result in total reimbursement for all Research Costs that would exceed the Research Cost Cap.

 

(iii) The Research Committee shall determine whether the amounts reflected in the Parties’ statements are consistent with this Section 2.4 within [**] after receipt of the statements described in Section 2.4(c)(ii) and determine the net difference ( “Net Difference” ) between the amounts reflected in such two statements. For purposes of this Section 2.4(c)(iii), the third sentence of Section 2.1(d)(iii) shall not apply.

 

(iv) Following the determination pursuant to Section 2.4(c)(iii), the Party that incurred the lower Research Costs in such Calendar Quarter shall pay to the other

 

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Party, within [**] of the end of such Calendar Quarter, an amount equal to [**] Percent ([**]%) of the Net Difference for such Calendar Quarter.

 

(d) Development of Back-up Compounds After Proof of Concept

 

(i) Within [**] after Proof of Concept is established, Gilead may request that Achillion provide additional research support, for a period of up to [**] after Proof of Concept is established, by conducting research and Development work on Back-up Compounds or in other areas. The Parties will negotiate in good faith the number of Achillion FTEs to be used and the work to be performed, and an extension to the Research Program Term, and will reflect any such agreement in an amendment to the Research Plan.

 

(ii) If Gilead requests that Achillion provide additional research support pursuant to above clause 2.4(d)(i), Gilead shall reimburse Achillion for one hundred Percent (100%) of the cost of Achillion FTEs requested. Such reimbursement will be at the applicable FTE Rate. Such reimbursement shall be prorated for the number of workdays actually worked by each FTE.

 

(iii) Within [**] following the end of each Calendar Quarter during which Achillion FTEs performed services pursuant to this Section 2.4(d)(iii), Achillion will send a statement of the amount owed by Gilead, and Gilead shall pay such amounts due within [**] of receipt of such invoice.

 

(iv) If, after Proof of Concept is established, Gilead wishes to Discover Back-up Compounds, and if the Parties agree that Achillion has the resources and capability to undertake such Discovery, Gilead shall offer to Achillion the opportunity to undertake such activities pursuant to this Section 2.4(d)(iv). If Achillion agrees to undertake such activities, Gilead shall fund not less than [**] Achillion FTEs at the FTE Rate to Discover Back-up Compounds, for a period ending upon the earlier of (1) the conclusion of [**] years after Gilead commences such Discovery activities, or (2) Gilead ceases such Discovery activities on Back-up Compounds.

 

2.5 Records and Reports

 

(a) Records. Achillion and Gilead shall each maintain records, in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, in laboratory notebooks (or equivalent), which shall fully and properly reflect all work done and results achieved in the performance of the Research Program by such Party.

 

(b) Copies and Inspection of Records. No more frequently than once each calendar year during the Research Program Term and for six (6) months thereafter, each Party shall have the right, during normal business hours and upon reasonable notice, to inspect and copy all records of the other Party referred to in Section 2.5(a); provided, however, that neither Party shall have the right to review or copy records to the extent that such records contain information that does not relate directly to Compounds, and either Party, in lieu of providing such access to its records, may elect to provide copies of the relevant records to the other Party. The receiving Party shall maintain such records and the information disclosed therein in confidence in accordance with Section 7.

 

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3. DEVELOPMENT

 

3.1 Development Committee

 

(a) Formation and Duration. No later than ten (10) days after Proof of Concept is established, Achillion and Gilead shall establish the Development Committee ( “Development Committee” ). Except to the extent otherwise provided by mutual written agreement of the Parties, the Development Committee shall disband at the end of the Development Program Term.

 

(b) Activities of the Development Committee. The Development Committee will act in an advisory capacity to Gilead and, in such capacity, will review and comment on the Development Plan and monitor, evaluate, discuss and comment on the Development Plan and the progress reports provided by Gilead pursuant to Section 3.1(d)(ii).

 

(c) Attendance

 

(i) Gilead shall designate three (3) named representatives of Gilead and Achillion shall designate three (3) named representatives of Achillion. Each Party shall appoint its respective representatives to the Development Committee and, from time to time, may substitute one or more of its representatives.

 

(ii) Additional representatives or consultants of a Party may from time to time, with the consent of the other Party (with such consent not to be unreasonably withheld) attend Development Committee meetings, subject to such representative’s and/or consultant’s written agreement to comply with the confidentiality and non-use obligations equivalent to those set forth in Section 7.

 

(iii) The Development Committee may establish such working groups or sub-committees as it may choose from time to time to accomplish its purposes.

 

(d) Meetings

 

(i) The Development Committee shall meet at least once each Calendar Quarter in accordance with a schedule established by mutual written agreement of the Parties, with the location for such meetings determined by agreement of the Parties.

 

(ii) Prior to each meeting, Gilead shall provide written progress reports to the Development Committee, describing Gilead’s Development activities and progress attained during the prior Calendar Quarter.

 

(iii) Either Party may call for non-scheduled meetings of the Development Committee for good cause, which shall occur at mutually agreeable times.

 

(iv) The Development Committee upon mutual agreement may meet by means of teleconference, videoconference or other similar communications equipment.

 

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(v) No Development Committee meeting may be conducted unless at least two (2) representatives of each Party are participating.

 

(vi) Each Party shall bear its own expenses related to the attendance at Development Committee meetings.

 

(e) Records. The Development Committee chair, or his/her designee, shall have responsibility for preparing minutes of each Development Committee meeting. Such minutes shall provide a description of the discussions at the meeting, a list of any actions or determinations approved by the Development Committee and any disagreements not resolved by the Development Committee. Such minutes shall be circulated to all members of the Development Committee within thirty (30) days following the Development Committee meeting.

 

3.2 Development Plan. Gilead shall, within [**] after Proof of Concept is established, draft a development plan ( “Development Plan” ) and deliver the Development Plan to the Development Committee. The Development Plan shall describe Gilead’s planned Development activities. The Development Plan shall at all times include a designation of [**].

 

3.3 Clinical Development. After Proof of Concept is established, Gilead and its Related Gilead Parties shall be solely responsible, at its sole expense, for all clinical Development of Licensed Products worldwide, including the conduct of any clinical Development of Licensed Products.

 

3.4 Regulatory

 

(a) Filings. Between the Effective Date and the date Proof of Concept is established, Achillion shall be responsible for and shall file and own all Drug Approval Applications. Upon establishment of Proof of Concept, Gilead shall become responsible for, and Achillion will transfer to Gilead, all Drug Approval Applications, and thereafter Gilead shall file and own all Drug Approval Applications and shall be responsible for all communications with Regulatory Authorities in relation thereto (to the extent permitted by law).

 

(i) Prior to establishment of Proof of Concept, Gilead and Achillion will collaborate to facilitate regulatory activities. In furtherance of that goal, Achillion shall promptly forward to Gilead copies of all Drug Approval Applications and communications with and decisions of Regulatory Authorities. Gilead shall have the right to review, comment upon and participate in any decision made with respect to a Drug Approval Application, and will be given notice of any in-person or telephonic meetings with Regulatory Authorities sufficient to permit Gilead’s participation in such meetings. Within ten (10) days of the Effective Date, Achillion shall provide Gilead with copies of any documents and communications described in this Section 3.4(a)(i) then in Achillion’s possession, and shall provide Gilead with any additional relevant information or assistance that Gilead reasonably requests.

 

(ii) The Parties shall, as soon as practicable after Proof of Concept is established, cooperate to transfer and provide copies of (to the extent that they are not then in Gilead’s possession) all Drug Approval Applications, Information, data, protocols, clinical study reports and Know-How that is reasonably required for Gilead to obtain Regulatory Approval for

 

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any Licensed Product. Further, Gilead shall keep Achillion reasonably apprised of the progress of all Drug Approval Applications through the progress reports presented to the Development Committee, and will provide Achillion copies of all reasonably requested regulatory filings within a reasonable time after their submission to the relevant Regulatory Authority.

 

(b) Labeling. To the extent permitted by law and Regulatory Authorities, Gilead shall identify Achillion as the licensor of each Licensed Product on the packaging and labeling for such Licensed Product in each country of the Territory in a manner approved in advance in writing by Achillion, such consent not to be unreasonably withheld.

 

3.5 Diligence. Gilead shall use reasonably diligent efforts to Develop at least one Licensed Product in the HCV Field in each Major Market. Solely for purposes of this Section 3.5, “reasonably diligent efforts” means those efforts that are consistent with the usual practice that a pharmaceutical company would reasonably undertake in pursuing the Development of a licensed product with a comparable potential market, risk, and revenues, assuming that such pharmaceutical company intends to bring such licensed product to market in the HCV Field [**].

 

4. COMMERCIALIZATION

 

4.1 Manufacturing. As soon as practicable, and in any event within sixty (60) days of the Effective Date, Achillion shall transfer to Gilead all material information relating to the manufacture of Compounds or Licensed Products, including but not limited to data, Information and Achillion Know-How that is reasonably required or related to the manufacturing of Compounds or Licensed Products, manufacturing specifications, raw materials, intermediates, API, and clinical supplies; provided, however, that Achillion may retain any materials, information or data that is reasonably required or necessary for Achillion to conduct Development pursuant to the Research Program or otherwise pursuant to this Agreement, to conduct development outside of the scope of this Agreement to the extent permitted by this Agreement, or to fulfill its existing obligations to Third Parties to the extent permitted by this Agreement. Gilead shall thereafter be responsible for the chemistry, manufacturing and control ( “CMC” ) of Compounds, clinical supplies and Licensed Products, and Achillion shall cooperate fully with Gilead and will provide Gilead with any information, materials reasonably available or assistance that Gilead reasonably requests.

 

4.2 Commercial and Product Support Activities

 

(a) Gilead Activities. Except as provided in Section 4.2(b), Gilead and its Related Gilead Parties shall be solely responsible, at its expense, for marketing and commercialization of one or more Licensed Products.

 

(b) Achillion Activities

 

(i) Achillion may make a one-time election to have field-based personnel ( “Field-Based Personnel” ) support Gilead’s commercial activities in the United States relating to Licensed Products to the extent and pursuant to the procedures set forth in this Section 4.2(b). The Parties will agree on the number of Field-Based Personnel that will support such activities and the duration of their period of service; provided that the number of such Field

 

19


Based Personnel shall be up to [**] individuals at any given time, or such greater number as the Parties mutually agree, and Field-Based Personnel shall serve, if Achillion so elects, for a period lasting up to [**]. Such Field Based Personnel (A) may be full- or part-time employees and (B) may be either (I) [**] assigned to work with physicians and other professionals [**] or (II) [**].

 

(ii) Gilead shall provide Achillion with a written notice, at any time after commencement of a Phase 3 Clinical Trial and no less than [**] before the filing of an NDA, to the effect that it intends to file such an NDA. Within [**] following receipt of such notice, Achillion shall provide Gilead with a written notice (A) indicating that it wishes to designate Field-Based Personnel to support Gilead’s commercial activities relating to Licensed Products; and (B) describing in reasonable detail the number and type of Field-Based Personnel it wishes to nominate to support Gilead.

 

(iii) As soon as practicable after receiving notice from Achillion pursuant to Section 4.2(b)(ii), the Parties shall meet and negotiate in good faith the identity of the Field-Based Personnel and the manner of their participation, taking into consideration the extent to which they have specialized knowledge or expertise related to the specific activity proposed to be conducted; whether they operate in geographic areas where Achillion has market presence or proximity; and the extent to which they are qualified by appropriate experience and qualifications to perform the work assigned to such Field-Based Personnel in a capable and professional manner.

 

(iv) All Field-Based Personnel shall operate under the supervision and control of Gilead’s Medical Affairs or National Accounts Divisions. Gilead may assign Field-Based Personnel to operate in any region of the United States it deems appropriate. All Field-Based Personnel shall comply with Gilead’s internal rules and regulations, including Promotional Guidelines, and shall be trained by Gilead at Gilead’s expense.

 

(v) Gilead shall have the right to remove any Field-Based Personnel designated by Achillion from their position for failures of performance or if Gilead reasonably determines such Field-Based Personnel have not complied with Gilead’s internal rules and regulations, including Gilead’s Promotional Guidelines. If Achillion elects for any reason to reduce the number of Field Based Personnel utilized pursuant to this Section 4.2(b), Achillion shall give Gilead not less than [**] prior written notice.

 

(c) Cooperation and Interaction

 

(i) Gilead will supply Achillion with a copy of its plan for commercializing a Licensed Product and will present and discuss such plan with Achillion. Senior management of Achillion shall be invited to attend such portions of conferences and meetings that pertain to the commercialization of Licensed Products.

 

(ii) Relevant Achillion Field-Based Personnel shall receive similar information and attend and participate at a similar level to equivalent Gilead personnel, including

 

20


but not limited to formal training, remote training, core skills training (including updates on medical practice, regulatory guidelines and presentation skills), national conferences, regional meetings, educational events, speaker’s bureaus, regional consultants meetings, medical conferences (including pre-conference briefing and booth staffing) and Phase 3b/4 program meetings.

 

(iii) Subject to Section 4.2(b)(iv), the Parties agree to consult with each other in good faith from time to time as necessary or appropriate as to matters that arise in connection with the use of Field-Based Personnel pursuant to this Section 4.2(b). Such consultations may cover matters such as the deployment, management and removal of Field-Based Personnel. Each Party shall each designate a principal contact for the purpose of conducting any such consultations.

 

4.3 Achillion’s Costs. All costs associated with any activities undertaken by Achillion pursuant to Section 4.2, including salary, benefits and travel of Field-Based Personnel designated pursuant to Section 4.2(b)(ii) and (iii), shall be borne solely by Achillion, except as otherwise expressly provided in Section 4.2(b)(iv).

 

4.4 Diligence. Gilead shall, itself and/or through Related Gilead Parties, at its own expense, use Commercially Diligent Efforts to commercialize and market at least one Licensed Product in the HCV Field in each Major Market.

 

5. LICENSES AND COVENANTS

 

5.1 License Grants to Gilead. Subject to the terms of this Agreement, Achillion hereby grants to Gilead an exclusive (even as to Achillion except to the extent provided below), royalty-bearing (as set forth in Section 6.5) license, with the right to sublicense subject to Section 5.3(d), under Achillion Technology to Develop, make, have made, use, sell, have sold, offer for sale and import Compounds and Licensed Products in the Field in the Territory; provided, however, that Achillion retains such rights under Achillion Technology as are necessary to perform its obligations under the Research Plan.

 

5.2 License Grant to Achillion. Subject to the terms and conditions of this Agreement, Gilead hereby grants to Achillion a non-exclusive, royalty-free license, without the right to sublicense, under Gilead Technology solely to perform Achillion’s obligations to conduct the Research Program.

 

5.3 Negative Covenants

 

(a) No Use of Achillion Technology. For a period beginning on the Effective Date and ending upon the expiration of the last to expire Royalty Term, Achillion shall not Develop or use Achillion Technology for Compounds, or permit any Third Party to conduct any such activities with respect to Achillion Technology for Compounds, except as expressly provided in this Agreement.

 

(b) No Research. Except as otherwise expressly provided in this Agreement, for a period beginning on the Effective Date and ending upon the expiration of the last to expire Royalty Term, Achillion shall not: (1) on its own behalf or for any Third Party conduct any

 

21


Development or commercialization of any Compound; nor (2) grant to any Third Party any license or other right to conduct any research, Development or commercialization of any Compound, unless Gilead consents pursuant to this Agreement.

 

(c) No Implied Licenses. No right or license under any Patents or Information of either Party is granted or shall be granted by implication or estoppel. All such rights or licenses are or shall be granted only as expressly provided in the terms of this Agreement.

 

(d) Major Market Sublicenses. Gilead shall not grant any sublicense for commercialization rights to any Achillion Technology to any Third Party in a Major Market in any arrangement except where (a) Gilead would continue to actively participate in such commercialization; and (b) such arrangement involves [**]. Notwithstanding the foregoing, Gilead shall have the right to grant a Third Party the right to use and sell Licensed Product in the Field in Japan.

 

5.4 Right of Discussion as to New HCV Compounds. Prior to executing any agreement under which Achillion or an affiliate controlled by Achillion would grant a Third Party a license or similar right to Develop or commercialize any New HCV Compound in the Territory, Achillion shall so notify Gilead in writing. Upon receipt of such notice, Gilead shall have [**] to present and discuss with the senior executive officers of Achillion its capabilities to participate in such Development or commercialization of such New HCV Compound. Unless otherwise agreed by the Parties in writing prior to the expiration of such [**] period, Achillion or its affiliate shall thereafter be free to enter into an agreement with any Third Party for the Development or commercialization of such New HCV Compound with no further obligation to Gilead. Gilead’s rights under this Section 5.4 shall expire on the earlier of (a) the [**] anniversary of the first Regulatory Approval of a Licensed Product; or (b) the date Achillion experiences a Change of Corporate Control.

 

5.5 Offsetting IP. Not less than [**] prior to entering into any agreement providing for payment of Third Party Royalties that Gilead proposes qualify as a payment for Offsetting IP, Gilead shall send Achillion a written notice describing in reasonable detail the terms of the agreement and reasons for entering into such agreement The Parties shall meet and discuss Achillion’s consent to having such Third Party Royalties included as payment for Offsetting IP, and therefore eligible for offset pursuant to Section 6.6(a), to the extent such consent is required. Achillion shall provide written notice to Gilead as to whether it so consents (if required), within [**] of such notice.

 

5.6 Agreements with Related Gilead Parties. Gilead shall not, without the prior written consent of Achillion, enter into any agreement for [**] with any Related Gilead Party that provides for [**] by such Related Gilead Party to Gilead [**], other than Related Gilead Party Royalties.

 

5.7 Combination Products. If Gilead intends to sell a Combination Product in any country in the Territory where the Compound contained in the Licensed Product is not sold separately in such country, the Parties will discuss in good faith an appropriate methodology for

 

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determining the basis of calculating the Net Sales of such Licensed Product in such country based on the relative contribution of the Compound to the price of the Combination Product.

 

6. COMPENSATION

 

6.1 Up-front Payment. Gilead shall make a one-time, non-refundable, non-creditable payment to Achillion of Five Million U.S. Dollars ($5,000,000) within thirty (30) calendar days of the Effective Date.

 

6.2 Purchase of Achillion Stock. Pursuant to the Stock Purchase Agreement dated the Effective Date, attached hereto as Exhibit 6.2A, Gilead shall purchase and Achillion shall sell to Gilead Five Million Dollars ($5,000,000) of Achillion Series C-l Preferred Stock at a price of U.S. $2.1735 Dollars per share. At the same time, Gilead and Achillion shall also enter into the Investor Rights Agreement attached as Exhibit 6.2B, and the Second Amended and Restated Stockholders’ Agreement, Exhibit 6.2C, each dated as of the Effective Date.

 

6.3 Research Cost Reimbursement. Each Party will reimburse the other Party for its work in furtherance of the Research Program to the extent and at the times provided in Section 2.

 

6.4 Milestone Payments

 

(a) Notices of Milestone. The Party responsible for achieving the Development and commercialization milestones described in this Section 6.4 shall, promptly after achieving each such milestone (but no later than [**] after such achievement), send a notice (which shall include any supporting information reasonably appropriate) to the other Party to such effect.

 

(b) Payment. Gilead will pay to Achillion the milestone payments set forth in this Section 6.4 on the same date that the notice described in Section 6.4(a) is sent; provided, however, that such notice relates to the first achievement of the corresponding milestone, or such milestone is otherwise eligible for payment as provided in this Section 6.4. Such milestone payments shall be nonrefundable.

 

(c) Lead Compound Events Triggering Obligation. Except as provided in Section 6.4(e), for any Licensed Product or Lead Compound that is at the time of the applicable event a Lead Compound, the milestone events for such Licensed Product shall consist of the following:

 

Milestone Event


  

Milestone Payment Amount


1.      The filing of [**]

   $[**]

2.      The first [**]

   $[**]

3.      The first [**]

   $[**]

 

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4.      Submission [**]

   $[**]

5.      Submission [**]

   $[**]

6.      The first Regulatory Approval of a Compound in the USA

   $[**]

7.      The first [**]

   $[**]

8.      The first [**]

   $[**]

9.      Achievement [**]

   $[**]

10.    Achievement [**]

   $[**]

 

(d) Back-up Compound Milestone Events Triggering Payment Obligation. Except as provided in Section 6.4(e), any Back-up Compound shall be eligible for milestone payments pursuant to this Section 6.4(d) if, at the time of the applicable event, it is a Back-up Compound. The milestone events for such Back-up Compound shall consist of those established in Section 6.4(c) with respect to Licensed Products comprising Lead Compounds, except that the amount owed for each milestone shall be [**] Percent ([**]%) of the amount shown in Section 6.4(c).

 

(e) Rules Regarding Multiple Milestone Payments. Notwithstanding anything in this Section 6.4 to the contrary, the following rules shall apply to the payment of milestone events.

 

(i) No milestone payment shall be payable more than once for any Licensed Product comprising a Lead Compound, no matter how many times achieved with respect to one or more Licensed Products.

 

(ii) Milestone payments may be paid more than once for one or more any Licensed Product(s) comprising a Back-up Compound.

 

(iii) If a Back-up Compound becomes a Lead Compound, such Lead Compound and any Licensed Product comprising such Lead Compound shall become eligible for milestone payments under Section 6.4(c) only to the extent that any such milestone has not previously been paid for any Lead Compound or Licensed Product comprising a Lead Compound.

 

(f) Non-Royalty Consideration Paid by Related Gilead Parties. Gilead shall pay Achillion, within [**] of receipt by Gilead, an amount equal to [**] Percent ([**]%) of any up-front, milestone and related payments paid by Related Gilead Parties for sublicenses of

 

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rights granted pursuant to Section 5.1; provided, however, that such milestone and related payments shall not include Related Gilead Party Royalties.

 

6.5 Royalties

 

(a) Royalties for Sales by Gilead. During the applicable Royalty Term in each country in the Territory, Gilead will pay Achillion, no later than [**] following the end of the preceding Calendar Quarter, a royalty payment on worldwide Net Sales of Licensed Product sold by Gilead and its Affiliates (but not Net Sales by Related Gilead Parties) in such country (the “Royalty”), subject to adjustment in accordance with Sections 6.6:

 

(i) [**] percent ([**]%) on such worldwide Net Sales that are less than or equal to $[**] in a given calendar year;

 

(ii) [**] percent ([**]%) on such worldwide Net Sales that are greater than $[**] and less than or equal to $[**] million in a given calendar year;

 

(iii) [**] percent ([**]%) on such worldwide Net Sales that are greater than $[**] Million in a given calendar year.

 

(b) Royalties for Sales by Related Gilead Parties. During the applicable Royalty Term in each country in the Territory, Gilead will pay Achillion, no later than [**] following the end of the preceding Calendar Quarter, a royalty payment on Net Sales of Licensed Product sold by Related Gilead Parties in such country ( “Sublicense Royalty” ), subject to adjustment in accordance with Section 6.6, of [**] percent ([**]%) on Net Sales by Related Gilead Parties.

 

(c) Royalties for Sublicense in the United States and European Market. In the event that Gilead grants a sublicense for commercialization rights to any Achillion Technology to any Third Party in the United States of America or the European Market pursuant to Section 5.3(d), for purposes of the definition of “Net Sales” and for calculating royalties under this Section 6.5, sales of Licensed Product by the sublicensee for such rights, or through such arrangement, shall be deemed to be sales by Gilead.

 

(d) Example. By way of example, if, in a given year, worldwide Net Sales of Licensed Product by Gilead and its Affiliates equal $[**], and worldwide Net Sales of Licensed Product by Related Gilead Parties equal $[**] (worldwide Net Sales, including Net Sales by Related Gilead Parties, thus are $[**]), then the royalty owed to Achillion shall equal $[**], calculated in the following manner:

 

Amount of Net Sales


   Royalty Rate

  Royalty Payment

Gilead Net Sales of first $[**]

   [**]   $[**] Million

Gilead Net Sales greater than $[**] and less than or equal to $[**]
(e.g., $[**])

   [**]   $[**]

Gilead Net Sales greater than $[**] (.e.g., $[**])

   [**]   $[**]

Related Gilead Party Net Sales
(e.g., $[**])

   [**]   $[**]
        

Total Royalty

       $[**]

 

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6.6 Adjustments

 

(a) Third Party Royalties. The royalty payments required to be paid on any given date pursuant to Section 6.5 shall be subject to an offsetting reduction on such date by Gilead in an amount equal to [**] Percent ([**]%) of the amount of Third Party Royalties that are paid to secure Offsetting IP; provided however, that:

 

(i) such offset may be made only to the extent such Third Party Royalties have not previously been subject to offset pursuant to this Section 6.6(a), and/or have not otherwise been subject to reimbursement pursuant to Section 6.6(c); and

 

(ii) no offset made by Gilead on such date pursuant to this Section 6.6(a) shall exceed an amount equal to [**] Percent ([**]%) of the amount otherwise due pursuant to Section 6.5 on such date.

 

Any amount that has not been offset on such date because of Section 6.6(a) shall be eligible for offset against the next succeeding royalty payment or payments due for such Licensed Product. If such deferred offset is again limited by Section 6.6(a), the deferred amount shall be subject to offset against future royalty payments for such Licensed Product successively until a total of [**] Percent ([**]%) of all Third Party Royalties made in respect of such Licensed Product have been offset against royalty payments paid by Gilead for such Licensed Product.

 

(b) Limitation on Royalties Due for Sales by Related Gilead Parties. Notwithstanding anything else in this Agreement to the contrary, including Section 6.6(a)(ii), the Sublicense Royalty in any Calendar Quarter paid pursuant to Section 6.5(b) with respect to a particular Related Gilead Party shall not, taken with all other royalty payments previously made by Gilead in respect of Net Sales by such Related Gilead Party, exceed [**] Percent ([**]%) of the difference between (i) and (ii) below:

 

(i) the Related Gilead Party Royalties paid, during such Calendar Quarter, to Gilead by such Related Gilead Party;

 

(ii) any other deductions or offsets pursuant to Section 6.6(a) applicable to the sale of such Licensed Products by such Related Gilead Party.

 

(c) Reimbursement by Achillion for Third Party Royalties

 

(i) If , prior to the First Commercial Sale of a Licensed Product, Gilead pays Third Party Royalties in respect of Compound, Achillion shall reimburse Gilead for

 

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[**] Percent ([**]%) of any such Third Party Royalty so paid for Offsetting IP identified by the Parties as of the Effective Date, within [**] of receipt by Achillion of an invoice from Gilead.

 

(ii) If, after the First Commercial Sale of a Licensed Product, Gilead or any Related Gilead Party pays Third Party Royalties in respect of Compound, Gilead shall be permitted to offset its royalty payments for such Licensed Product pursuant to Section 6.5 to the extent and as provided in Section 6.6(a).

 

(d) Third Party Infringement Losses. For purposes of this Section 6.6, Third Party Infringement Losses arising from infringement of Third Party Patents that claim or are directed to the research, Development, manufacture, use, sale, offer for sale or importation of Compounds, or misappropriation of Third Party trade secrets directed to the research, Development, manufacture, use, sale, offer for sale or importation of Compounds, shall be included with and be treated in the same manner as Third Party Royalties that are paid to secure Offsetting IP.

 

6.7 Payment; Report. Following the First Commercial Sale of a Licensed Product, Gilead shall furnish to Achillion, within [**] following the end of each Calendar Quarter, a written report for such Calendar Quarter showing, for each Licensed Product, on a country-by-country basis, (A) the total amount invoiced by Gilead or its Related Gilead Parties for sales to a Third Party (whether an end-user, wholesaler or otherwise) in the Territory; (B) total Net Sales; (C) the calculation of the amount of any applicable offsets or limitations pursuant to Section 6.6; and (D) the calculation of royalties due. Gilead shall keep complete and accurate records in sufficient detail to enable the Royalties payable hereunder to be determined.

 

6.8 Exchange Rate; Manner and Place of Payment

 

(a) Payments. Unless otherwise specified in writing by Achillion, all payments to be made by Gilead to Achillion under this Agreement shall be made in United States dollars and shall be paid by bank wire transfer in immediately available funds from a bank account in the United States selected by Gilead to a bank account in the United States designated in writing by Achillion from time to time.

 

(b) Sales Outside the United States. With respect to sales outside the United States, royalty amounts owed shall first be calculated in the currency of sale, and then such amounts shall be converted into U.S. Dollars based on applicable currency exchange rates (as provided in Section 6.8(c)), and such Dollar amount of the royalties shall be paid to Achillion.

 

(c) Exchange Rate. The conversion of non-U.S. dollar sales into U.S. dollar sales shall be calculated in accordance with Gilead’s then current foreign exchange conversion methodology for external financial reporting to the Securities and Exchange Commission.

 

(d) Blocked Conversion. In any country where conversion of the local currency is blocked and such currency cannot be removed from the country, Gilead will pay Achillion in local currency by deposit in a local bank account designated by Achillion.

 

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6.9 Records and Audit

 

(a) Records. Gilead shall maintain, and shall require its Affiliates, Related Gilead Parties and other sublicensees to maintain, complete and accurate books and records in connection with the sale of Licensed Products hereunder, as necessary to allow the accurate calculation of the royalties due to Achillion hereunder.

 

(b) Audit. Upon Achillion’s written notice to Gilead with reasonable advance notice and not more than once in each calendar year, Gilead shall permit external accountants selected by Achillion and reasonably acceptable to Gilead, at Achillion’ expense (except as set forth in Section 6.9(c)), to have access during normal business hours to such of the records of Gilead and its Affiliates as may be reasonably necessary to verify the accuracy of the royalty reports hereunder for any calendar year ending not more than three (3) years prior to the date of such request. Gilead shall also provide the accountants such documentation relating to sales by Related Gilead Parties and other sublicensees as are reasonably necessary to verify the accuracy of such royalty reports. The form of the report prepared by auditors shall be agreed upon prior to commencing the audit and in such report the accountants shall disclose to Achillion only whether the royalty reports are correct or incorrect and the specific details concerning any discrepancies. No other information shall be provided to Achillion. Gilead shall be entitled to one (1) copy of all final reports and analyses resulting from the audit concurrently to such report being issued to Achillion by such accountant In no event shall the accountants include any data in such reports considered confidential or proprietary by Gilead.

 

(c) Discrepancies. Except as otherwise provided in this Section 6.9(c), if such accountants identify a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within thirty (30) days of the date of receiving such accountant’s written report, or as otherwise agreed upon by the Parties, plus interest calculated in accordance with Section 6.10. The Party required to pay the discrepancy may challenge the results of such accountants’ report by providing notice within fifteen (15) days to the other Party. The Parties will then mutually agree to designate an accountant to verify the accuracy of the initial report. The fees charged by such accountants shall be paid by Achillion; provided, that if the audit uncovers an underpayment of royalties by Gilead in an amount that exceeds five percent (5%) of the total royalties owed, then the reasonable fees of such accountants shall be paid by Gilead.

 

(d) Confidentiality. Achillion shall treat all financial information subject to review under this Section 6.9 or under any sublicense agreement in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause the accountants selected by it to enter into an acceptable confidentiality agreement with Gilead obligating such accountants to retain all such information in confidence pursuant to such confidentiality agreement.

 

6.10 Late Payments. Any amounts not paid when due under this Agreement shall be subject to interest from and including the date payment is due through and including the date upon which Achillion has collected immediately available funds in an account designated by Achillion at an annual rate equal to the sum of two percent (2%) plus the annual prime rate of interest quoted in the Money Rates section of the West Coast edition of the Wall Street Journal calculated daily on the basis of a 365-day year, or similar reputable data source, or, if lower, the highest rate permitted under applicable law.

 

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6.11 Taxes. If laws, rules or regulations require withholding of income taxes, VAT, royalty withholding taxes, or other taxes imposed upon payments to Achillion set forth in this Section 6, Gilead shall make such withholding payments as required and subtract such withholding payments from the payments set forth in this Section 6. Gilead shall submit appropriate proof of payment of the withholding taxes to Achillion within a reasonable period of time following such payment. Each Party shall provide reasonable assistance to the other Party in minimizing or claiming exemptions from, refunds of, or credits for, any such applicable withholding taxes, upon the other Party’s written request.

 

6.12 Right of First Refusal for Sale of Royalty Rights

 

(a) Notice of Sale of Royalty Rights. If at any time Achillion desires to sell, assign or transfer to a Third Party, pursuant to a bona fide offer received from such Third Party, the rights to receive payment owed by Gilead to Achillion under this Section 6 ( “Royalty Rights” ), Achillion shall send a written notice to Gilead ( “Offer Notice” ) not less than [**] prior to consummating any such transaction. The Offer Notice shall describe in reasonable detail the terms and conditions of the offer and all other material information, including the identity of the Third Party.

 

(b) Gilead Right to Match Offer. Gilead shall have [**] after receipt of the Offer Notice in which to elect to acquire, for itself, the Royalty Rights, on terms no less favorable than those described in the Offer Notice. If Gilead makes such an election, Gilead shall consummate any such transaction within [**] of sending its election to Achillion.

 

(c) Waiver of Gilead Rights. If Gilead does not make a timely election within [**] to acquire the Royalty Rights, then Achillion shall be permitted, within [**] of the date of the Offer Notice, to consummate the transaction that was the subject of the Offer Notice with such Third Party, on terms no less favorable to Achillion than those contained in the Offer Notice. If Achillion timely consummates such a transaction, Gilead’s rights contained in this Section 6.12 shall terminate and shall be of no further force or effect. If Achillion does not timely consummate such a transaction with such Third Party on terms at least as favorable as those were contained in the Offer Notice, Gilead’s rights contained in this Section 6.12 shall remain in effect.

 

7. CONFIDENTIAL INFORMATION

 

7.1 Nondisclosure Obligation

 

(a) Confidential Information. All Information disclosed by one Party to the other Party hereunder (“Confidential Information”) shall be maintained in confidence by the receiving Party and shall not be disclosed to any non-Party or used for any purpose except to exercise its rights and perform its obligations under this Agreement without the prior written consent of the disclosing Party, except to the extent that the receiving Party can demonstrate by competent written evidence that such Information:

 

(i) is known by the receiving Party at the time of its receipt and, not through a prior disclosure by the disclosing Party, as documented by the receiving Party’s business records;

 

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(ii) is in the public domain other than as a result of any breach of this Agreement by the receiving Party;

 

(iii) is subsequently disclosed to the receiving Party on a non-confidential basis by a Third Party who may lawfully do so; or

 

(iv) is independently discovered or developed by the receiving Party without the use of Confidential Information provided by the disclosing Party, as documented by the receiving Party’s business records.

 

(b) Return of Confidential Information Upon Expiration or Termination of Agreement. Within thirty (30) days after any expiration or termination of this Agreement, each party shall destroy (and certify to the other Party such destruction) or return all Confidential Information provided by the other Party except as otherwise set forth in this Agreement, and except that each Party may retain a single copy of the Confidential Information in its confidential legal files for the sole purpose of ascertaining its ongoing rights and responsibilities regarding the Confidential Information.

 

7.2 Permitted Disclosures

 

(a) Permitted Disclosure. Each Party may disclose Confidential Information provided by the other Party to the extent such disclosure is reasonably necessary in the following instances:

 

(i) disclosure to governmental or other regulatory agencies in order to obtain Patents on Achillion Technology or to gain or maintain approval to conduct clinical trials or to market Licensed Product (in each case to the extent permitted by this Agreement), but such disclosure may be only to the extent reasonably necessary to obtain Patents or authorizations;

 

(ii) complying with applicable court orders or governmental regulations, including without limitation rules or regulations of the Securities and Exchange Commission, or by rules of the National Association of Securities Dealers, any securities exchange or NASDAQ; provided, however, that the receiving Party shall first have given notice to the other Party hereto in order to allow such Party the opportunity to seek confidential treatment of the Confidential Information;

 

(iii) disclosure by Gilead to Related Gilead Parties or distributors for the sole purpose of conducting Development and/or commercialization of Compounds and Licensed Products in accordance with the terms and conditions of this Agreement on the condition that such Related Gilead Parties agree to be bound by confidentiality and non-use obligations at least equivalent in scope to those contained in this Agreement; provided the term of confidentiality for such Related Gilead Parties shall be no less than five (5) years; or

 

(iv) disclosure to consultants, agents or other Third Parties solely to the extent required to accomplish the purposes of this Agreement or in connection with due diligence or similar investigations by such Third Parties, and disclosure to potential Third Party investors in confidential financing documents, in each case on the condition that such Third Parties agree to be bound by confidentiality and non-use obligations at least equivalent in scope to those

 

30


contained in this Agreement or for the purposes of such financing; provided the term of confidentiality for such Third Parties shall be no less than three (3) years.

 

(b) Written Agreements. Each Party shall obtain written agreements from each of its employees and consultants who perform work on the Research Program, which agreements shall obligate such persons to similar obligations of confidentiality and to assign to such Party all inventions made by such persons during the course of performing the Research Program. Each Party will notify the other Party promptly upon discovery of any unauthorized use or disclosure of the Confidential Information of the other Party.

 

(c) Required Disclosure. If a Party is required by judicial or administrative process to disclose Information that is subject to the non-disclosure provisions of Section 7.1, such Party shall promptly inform the other Party of the disclosure that is being sought in order to provide the other Party an opportunity to challenge or limit the disclosure obligations. Information that is disclosed by judicial or administrative process shall remain otherwise subject to the confidentiality and non-use provisions of this Section 7, and the Party disclosing Information pursuant to law or court order shall take all reasonable steps necessary, including without limitation obtaining an order of confidentiality, to ensure the continued confidential treatment of such Information.

 

7.3 Publication. If a Party, its employees or consultants wishes to make a written publication or oral presentation related to a Compound, that Party shall deliver to the non-publishing Party a copy of the proposed written publication or an outline of an oral disclosure at least thirty (30) days prior to submission for publication or presentation. The non-publishing Party shall have the right to review and propose modifications to the publication or presentation for patent reasons, trade secret reasons or business reasons or (b) to request a reasonable delay in publication or presentation in order to protect patentable information. If the non-publishing Party requests modifications to the publication or presentation, the Party wishing to make such written publication or oral presentation shall edit such publication or presentation to prevent disclosure of trade secret or proprietary business information of the non-publishing Party prior to submission of the publication or presentation.

 

7.4 Publicity/Use of Names

 

(a) General. Each Party agrees to use reasonable efforts in press releases, web pages, or other public documents issued by a Party which mention a Compound Licensed Product to generally credit the other Party as licensor of licensee, as applicable. Either Party shall be free to disclose, without the other Party’s prior written consent, the existence of this Agreement, the identity of the other Party and those terms of the Agreement which have already been publicly disclosed in accordance herewith.

 

(b) Trademarks. Except as set forth in Section 7.4(a), or as expressly permitted by this Agreement, neither Party shall use the name, trademark, trade name or logo of the other Party or its employees in any publicity, news release or disclosure relating to this Agreement or its subject matter, without the prior express written permission of the other Party.

 

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(c) Allowed Disclosure. A draft press release announcing the execution of this Agreement is attached to this Agreement as Exhibit 7.4. The Parties acknowledge that each Party may desire or be required to issue subsequent press releases relating to the Agreement or activities thereunder.

 

(i) Gilead may issue such press releases or otherwise make such public statements or disclosures as it considers appropriate, provided that it does not disclose any Confidential Information of Achillion. Until the expiration of the Development Program Term, prior to making any disclosure under this Section 7.4(c)(i) Gilead shall provide Achillion with not less than 48 hours to review and comment on any such press releases, statements or disclosures, except to the extent that doing so is not feasible within the timeframe required for compliance with any laws, regulations or market disclosure requirements.

 

(ii) Achillion agrees to consult with Gilead reasonably and in good faith with respect to the text and timing of such press releases or public disclosures prior to the issuance thereof. Notwithstanding the foregoing, Achillion may issue such press releases or otherwise make such public statements or disclosures (such as in annual reports to stockholders or filings with the Securities and Exchange Commission) as it determines, based on advice of counsel, are reasonably necessary to comply with laws or regulations or for appropriate market disclosure; provided, however, that (A) Achillion does not disclose any Confidential Information of Gilead; and (B) Achillion shall first provide Gilead with not less than 48 hours to review and comment on any such press releases, statements or disclosures, except to the extent that doing so is not feasible within the timeframe required for compliance with such laws, regulations or market disclosure requirements.

 

(d) Protection of Interests. The Parties will use commercially reasonable efforts to ensure that the content of any oral statement or written disclosure or publication will comply with applicable laws and regulations and will not adversely affect the Parties’ commercial interests.

 

8. REPRESENTATIONS AND WARRANTIES

 

8.1 Mutual Representations and Warranties. Each Party hereby represents and warrants to the other Party as follows:

 

(a) Corporate Existence and Power. It is a corporation duly organized, validly existing and in good standing under the laws of the state in which it is incorporated, and has full corporate power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as contemplated in this Agreement, including, without limitation, the right to grant the licenses granted hereunder.

 

(b) Authority and Binding Agreement. As of the Effective Date, (a) it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder, (b) it has taken all necessary corporate action on its part required to authorize the execution and delivery of the Agreement and the performance of its obligations hereunder; and (c) the Agreement has been duly executed and delivered on behalf of such Party,

 

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and constitutes a legal, valid and binding obligation of such Party and is enforceable against it in accordance with its terms.

 

(c) No Conflict. It has not entered, and will not enter, into any agreement with any Third Party which is in conflict with the rights granted to the other Party under this Agreement, and has not taken and will not take any action that would in any way prevent it from granting the rights granted to the other Party under this Agreement, or that would otherwise materially conflict with or adversely affect the rights granted to the other Party under this Agreement.

 

8.2 Achillion Representations and Warranties. Achillion represents and warrants to Gilead as follows:

 

(a) Non-infringement of Third Party Rights. As of the Effective Date, it is unaware of any Patents or trade secret rights owned or controlled by a Third Party, that would dominate, or be infringed or misappropriated by the conduct of activities under the Research Program, and has received no written claims relating to any claims of such domination, infringement or misappropriation.

 

(b) Non-infringement by Third Parties. As of the Effective Date, it is unaware of any activities by Third Parties that would constitute infringement or misappropriation of any Achillion Technology relating to any Compound.

 

(c) Title. As of the Effective Date, it has sufficient legal and/or beneficial title under its intellectual property rights necessary to perform activities contemplated under this Agreement and to grant the licenses contained in this Agreement.

 

8.3 No Other Representations or Warranties. The express representations and warranties stated in this Section 8 are in place of all other representations and warranties, express, implied, or statutory, including without limitation, warranties of merchantability, fitness for a particular purpose, non-infringement or non-misappropriation of Third Party intellectual property rights, title, custom or trade.

 

9. OWNERSHIP OF INVENTIONS AND INTELLECTUAL PROPERTY RIGHTS

 

9.1 Inventorship. Each Party shall own any inventions made solely by its employees or agents in their activities hereunder. Inventions hereunder made jointly by employees or agents of both Parties shall be owned jointly by the Parties (“Joint Inventions”). Inventorship shall be determined in accordance with U.S. patent laws. To the extent that the Parties file Patents directed to Joint Inventions (“Joint Patents”), the Parties will negotiate in good faith an amendment to this Agreement that will, for the purposes of this Section 9, treat such Joint Patents as Achillion Patents and will otherwise reasonably address other issues related thereto.

 

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9.2 Patent Procurement

 

(a) Prosecution

 

(i) Within ten (10) days after the Effective Date, Achillion shall provide powers of attorney for Achillion Patents to Gilead and Gilead shall be responsible for the prosecution and maintenance of the Achillion Patents on behalf of Achillion. As further described below, Achillion shall have the right to review and comment upon such prosecution by Gilead of the Achillion Patents in the jurisdictions of the Territory.

 

(ii) Gilead shall be responsible for [**] percent ([**]%) of the Patent Costs and Achillion shall be responsible for [**] percent ([**]%) of the Patent Costs. Prior to the Effective Date, Achillion shall provide a detailed statement of the Patent Costs incurred prior to the Effective Date and Gilead shall reimburse Achillion for [**] percent ([**]%) of such costs within [**] after the Effective Date. Thereafter, a Party seeking reimbursement of Patent Costs shall invoice the other Party on a quarterly basis in arrears, and shall provide copies of receipts and counsel bills supporting such invoice. The other Party shall pay its share of such Patent Costs within [**].

 

(iii) As used herein, “prosecution” shall mean any procedure or practice before an administrative agency such as the United States Patent and Trademark Office, or an equivalent agency, including but not limited to interferences, reexaminations, reissues, oppositions, and the like.

 

(iv) Gilead shall furnish Achillion with copies of each communication regarding an Achillion Patent from a patent authority promptly following issuance of such communication. Gilead shall also furnish Achillion with copies of each draft submission regarding an Achillion Patent to a patent authority of any jurisdiction in the Territory no later than [**] prior to the date such submission is proposed to be made, in the state that such submission is reasonably in at such time (which may, for example, be in the form of descriptions of experiments and experimental data that may be used to demonstrate an actual reduction to practice of the relevant invention, which experiment may be ongoing) and will consider reasonably Achillion’s comments thereon. If Achillion does not provide Gilead with reasonably timely comments, Gilead shall be free to proceed with its submission or other contemplated action.

 

(v) Notwithstanding anything in this Section 9.2 to the contrary, Gilead shall always be entitled to proceed with any submission or other contemplated action if it determines time is of the essence, provided that Gilead makes reasonable efforts to inform Achillion as early as practicable and to consider its comments where applicable.

 

(vi) Gilead will make reasonable efforts to provide Achillion an update to any draft submission prior to filing to enable Achillion to monitor progress and further comment on the draft, and shall provide Achillion with a copy of each submission to a patent authority of a jurisdiction within the Territory regarding an Achillion Patent reasonably promptly after making such filing.

 

(vii) If either Party becomes aware of any patents, information or proceeding that relate to Achillion Patents that may adversely impact the validity, title or enforceability of Achillion Patents in the Territory, such Party shall promptly notify the other Party of such patent, information or proceeding.

 

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(b) Abandonment. If Gilead determines to abandon or not maintain any Achillion Patent anywhere in the Territory, then Gilead shall provide Achillion with thirty (30) days prior written notice of such determination and shall provide Achillion with the opportunity to prosecute and maintain such claim or Patent at its sole expense.

 

(c) Diligence. Gilead shall use Commercially Diligent Efforts to pursue claims in the Achillion Patents in a manner consistent with applicable law in the HCV Field [**]. It is expressly understood by the Parties that this Section 9.2(c) does not obligate Gilead to pursue claims in the Achillion Patents in every country of the Territory.

 

(d) Patent Counsel. Gilead shall have the right to use outside patent counsel in the prosecution or maintenance of any Achillion Patent at any time during the term of this Agreement; provided, however, that Achillion may object to the retention or continued retention of such counsel if Achillion reasonably believes such retention would be prejudicial to its intellectual property interests (including, without limitation, conflicts of interest, such as if outside counsel prosecutes patents for products similar to the Licensed Product(s) for Third Parties). In all cases, Achillion shall provide cooperation to Gilead or any patent counsel selected by Gilead (and not reasonably objected to by Achillion as provided for in this Section 9.2(d)), including, without limitation, providing references, publications or documents, granting interviews and access to scientists, providing data and laboratory notebooks, and granting interviews with or otherwise providing Achillion employees where necessary for further prosecution of Patents.

 

(e) Interference, Opposition, Reexamination and Reissue. Gilead shall inform Achillion of any request for, or filing or declaration of, any interference, opposition, or reexamination relating to Achillion Patents within thirty (30) days of learning of such event. Achillion shall reasonably cooperate with Gilead with respect to such interference, opposition, or reexamination. Achillion shall have the right to review and consult with Gilead regarding any submission to be made in connection with such proceeding. Gilead shall give Achillion timely notice of any proposed settlement of an interference relating to an Achillion Patent, and shall not enter into such settlement without Achillion’s prior written consent (such consent not to be unreasonably withheld).

 

9.3 Patent Term Restoration. Gilead shall obtain patent term restoration or supplemental protection certificates or their equivalents in any country in the Territory where applicable to Achillion Patents covering a Licensed Product.

 

9.4 Infringement by Third Parties

 

(a) Notice. If either Party learns of any infringement of Achillion Patents, or any misappropriation or misuse of Know-How, of which the other Party is a sole owner, co-owner or licensee, such Party shall promptly notify the other Party of such infringement, misappropriation or misuse.

 

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(b) Gilead’s Right to Bring Suit

 

(i) Gilead shall have the sole right, but not the obligation, to initiate and prosecute any legal action to enforce its rights in and to any Gilead Technology at its own expense and in the name of Gilead.

 

(ii) As the exclusive licensee of Achillion Technology, Gilead shall have the first right, but not the obligation, to initiate and prosecute any legal action or defense with respect to any infringement of Achillion Technology by Third Parties at its own expense and, if necessary, to name Achillion as a co-party, or to control if any declaratory judgment action relating thereto, and Gilead shall pay all attorneys fees and costs associated with such action.

 

(iii) If, within ninety (90) days or ten (10) days before the time limit, if any, set forth in the appropriate laws and regulations for the filing of such actions, whichever comes first, Gilead fails to take such action, or if Gilead informs Achillion that it elects not to exercise such first right, Achillion (or its designee) thereafter shall have the right either to initiate and prosecute such action or to control the defense of such declaratory judgment and Achillion shall pay all attorneys fees and costs associated with such action.

 

(c) Cooperation. For any action to terminate any infringement of Achillion Patents, or any misappropriation or misuse of Achillion Know-How or infringement of Gilead Patents, or any misappropriation or misuse of Gilead Know-How, if either Party is unable to initiate or prosecute such action solely in its own name, the other Party shall join such action voluntarily and shall execute all documents necessary to initiate litigation to prosecute and maintain such action. In connection with any such action, Gilead and Achillion shall cooperate fully and will provide each other with any information or assistance that either reasonably requests. Each Party shall keep the other informed of developments in any such action or proceeding, including, to the extent permissible by law, the consultation and approval of any offer related thereto.

 

(d) Costs and Awards. Any recovery obtained by either or both Gilead and Achillion in connection with or as a result of any action contemplated by this Section 9.4, whether by settlement or otherwise, shall be shared in order as follows:

 

(i) The Party which initiated and prosecuted the action shall recoup all of its costs and expenses incurred in connection with the action, plus a premium of [**] percent ([**]%) of such costs and expenses;

 

(ii) The other Party shall then, to the extent possible, recover its costs and expenses incurred in connection with the action, plus a premium of [**] percent ([**]%) of such costs and expenses;

 

(iii) Any remaining amounts after such reimbursement of the Parties’ costs and expenses shall be awarded to the Party which initiated and prosecuted the action. If such award is obtained by Gilead and such award is in excess of both Parties’ costs, expenses and associated [**] percent ([**]%) premium, the amount of such excess shall be considered Net Sales in the Calendar Quarter it is received for purposes of calculating royalties payable by Gilead in accordance with Section 6.5 if the recovery is for infringement by a product that is

 

36


competitive to a Licensed Product. Any other or additional recovery obtained by either Party shall be allocated [**] percent ([**]%) to Gilead and [**] percent ([**]%) to Achillion.

 

(e) Certifications. Each Party shall inform the other Party of any certification regarding any Achillion Patents pertaining to Compounds licensed to Gilead it has received pursuant to either 21 U.S.C. §§ 355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) or its successor provisions, or Canada’s Patented Medicines (Notice of Compliance) Regulations Article 5, or any similar provisions in a country other than the United States and Canada, and shall provide the other Party with a copy of such certification within five (5) days of receipt by such Party. Achillion’s and Gilead’s rights with respect to the initiation and prosecution of any legal action as a result of such certification or any recovery obtained as a result of such legal action shall be as defined in this Section 9.4.

 

9.5 Infringement of Third Party Rights

 

(a) Notice. If any Licensed Product manufactured, used or sold by either Party, its Affiliates, licensees or sublicensees under this Agreement becomes the subject of a Third Party claim, or there is the potential for a claim, of patent infringement relating to the manufacture, use, sale, offer for sale or importation of Licensed Product, the Party first having notice of the claim shall promptly notify the other Party, and the Parties shall promptly meet to consider the claim and the appropriate course of action.

 

(b) Defense

 

(i) Gilead shall have the right, but not the obligation, to defend against such claim or initiate any declaratory judgment action relating to a Compound or Licensed Product or bring any such action necessary to protect its interest in such Compound or Licensed Product, at its own expense, and Achillion shall have the right to participate in any such suit, at its own expense. The Parties shall reasonably cooperate with respect to the defense of the claim, including if required to conduct such defense, furnishing a power of attorney.

 

(ii) If, within ninety (90) days of receiving the notice provided for in Section 9.5(a), or ten (10) days before the time limit, if any, set forth in the appropriate laws and regulations for the filing of a claim or response in such actions, whichever comes first, Gilead fails to take such action, or if Gilead informs Achillion that it elects not to exercise such first right, Achillion (or its designee) thereafter shall have the right to defend against such claim or initiate any declaratory judgment action relating to a Compound or Licensed Product or bring any such action necessary to protect its interest in such Compound or Licensed Product, and may claim indemnification under Section 11.1 for such action. The Parties shall reasonably cooperate with respect to the defense of the claim, including if required to conduct such defense, furnishing a power of attorney.

 

9.6 Other Damages. In the event that Gilead, its Affiliates or sublicensees is held liable for increased damages or attorneys fees during the course of a suit against a Third Party brought under Section 9.4 or 9.5, or in any suit against a Third Party or a claim under the Sherman Act (15 U.S.C. §§ 1 et. seq.) or other applicable statute, Gilead shall bear all costs for damages in any action brought by Gilead or where Gilead has not joined Achillion as a party to

 

37


such action provided, however, mat Achillion will bear all costs for damages or fees under this Section 9.6 associated with any Patent prosecuted by Achillion that is held unenforceable due to inequitable conduct, or similar conduct, in such prosecution as a result of the action or inaction of Achillion or its Affiliates, by a decision of a court or government agency of competent jurisdiction, that is unappealable or unappealed within the time allowed for appeal, if the action or inaction held to constitute such conduct, was unknown to Gilead when it initiated such defense or suit

 

9.7 Settlement. Each Party shall give the other Party timely written notice of the proposed settlement of any action under Sections 9.4 or 9.5, and neither Party shall consent to the entry of any judgment or settlement or otherwise compromise any such action or suit in a way that adversely affects the other Party’s intellectual property rights or its rights or interests with respect to Compounds or Licensed Products without such other Party’s prior written consent (not to be unreasonably withheld).

 

10. TERM AND TERMINATION

 

10.1 Term. This Agreement shall commence on the Effective Date and, unless terminated earlier pursuant to Sections 10.2 or 10.3, shall be in full force and effect until the expiration of the last to expire Royalty Term.

 

10.2 Elective Termination by Gilead. Gilead shall have the right in its sole discretion and for any reason to terminate this Agreement in its entirety, at any time after the Blackout Period, upon one hundred twenty (120) days written notice to Achillion.

 

10.3 Termination for Material Breach. If a Party materially breaches this Agreement, the other Party may terminate this Agreement effective ninety (90) days after providing written notice to the breaching Party, if within that time the breaching Party fails to cure its material breach and the non-breaching Party does not withdraw its termination notice.

 

10.4 Effects of Termination. If a Party terminates this Agreement under Sections 10.2 or 10.3, all terms and provisions (including but not limited to all Royalty Terms and Achillion’s covenants under Section 5.3) shall terminate as of the effective date of termination, except as otherwise expressly provided in this Section 10.4 and in Section 10.5.

 

(a) Gilead Elective Termination. If Gilead terminates this Agreement pursuant to Section 10.2 the provisions of Section 10.4(b) shall apply, except that the license grants in Section 5.1 shall terminate throughout the Territory.

 

(b) Termination for Gilead Breach. If Achillion terminates this Agreement pursuant to Section 10.3:

 

(i) the Parties shall pay any amounts due pursuant to Section 2.4, Section 6 and Section 9 prior to the date of termination;

 

(ii) In the event of a material breach by Gilead under Section 3.5 or 4.4, Achillion’s termination rights shall be on a Major Market-by-Major Market basis with respect to Major Markets affected by such material breach (and in the event Achillion terminates

 

38


in all Major Markets pursuant to this Section 10.4(b)(ii), Achillion shall also have the right to terminate this Agreement in the remainder of the Territory);

 

(iii) In the event of a material breach by Gilead of obligations under this Agreement, other than those under Section 3.5 or 4.4, that is specific to a Licensed Product, Achillion’s termination rights under Section 10.3 shall be on a Licensed Product-by-Licensed Product basis in all countries affected by such breach;

 

(iv) Gilead shall assign and promptly transfer to Achillion, or its Affiliates as requested by Achillion, at no expense to Achillion or its Affiliates, all of Gilead’s right, title and interest in and to (A) all regulatory filings (such as INDs and drug master files), Regulatory Approvals, and clinical trial agreements (to the extent assignable and not cancelled) for Licensed Product(s) or Compound(s), to the extent that Achillion elects to continue Development of such Licensed Product(s) or Compound(s); (B) all data, including clinical data, materials and information of any kind or nature whatsoever, in Gilead’s possession or in the possession of its Affiliates or its or their respective agents related to the Licensed Produces) or any Compound(s); (C) all trademarks related to Licensed Products (if such termination occurs after approval of such trademark by a Regulatory Authority); and (D) all material information, and any other information reasonably requested and required by Achillion, relating to the manufacture of Compounds and/or Licensed Products;

 

(v) Achillion shall revoke (and Gilead shall allow revocation of) any powers of attorney for Achillion Patents that Gilead holds as of the time of such termination;

 

(vi) Gilead shall supply (or cause its Third Party manufacturers to supply) Licensed Produces) and/or Compound(s) to Achillion to the extent Gilead had, prior to such termination, been manufacturing Licensed Produces) and/or Compound(s) and, at Achillion’s request, shall assist in the transfer of manufacturing processes to new suppliers;

 

(vii) In the event that Gilead supplies Licensed Product and/or Compounds pursuant to Section 10.4(b)(vi), Achillion shall pay Gilead (1) its out-of-pocket costs, to the extent such manufacture, transfer and supply activities are conducted by Third Parties and/or (2) a reasonable market rate, to the extent that Gilead conducts such manufacture, transfer and supply activities. The Parties will cooperate to effect such transfer as soon as practicable. In any event, Gilead’s obligations to transfer and supply under Sections 10.4(b)(vi) and (vii) shall expire within [**] after such termination.

 

(viii) Achillion may elect to acquire a license to intellectual property Controlled by Gilead that is incorporated into a Compound or Licensed Product, with a right to sublicense, solely to Develop, make, have made, use, sell, have sold, offer for sale, and import such Compound or Licensed Product in the Field in the Territory. In the event of such election, the Parties shall negotiate in good faith commercially reasonable terms for such license; provided, however, that such license shall not include any up-front fees or milestone payments unless both Parties agree.

 

(ix) In the event that, at the time of termination, there is a Combination Product in Development or if such Combination Product has undergone a First Commercial Sale,

 

39


the Parties shall, in good faith, negotiate an arrangement under which (i) the Parties shall jointly Develop and commercialize such Combination Product; (ii) each Party shall bear its own costs associated with its commercialization activities; (iii) each Party shall share in the economic benefit of any such arrangement in accordance with the relative contribution of such Party’s compound(s); and (iv) each Party would grant to the other Party a nonexclusive license to any intellectual property rights necessary solely to permit the arrangements described in this Section

 

(c) Termination for Achillion Breach. If Gilead terminates this Agreement pursuant to Section 10.3:

 

(i) the Parties shall pay any amounts due pursuant to Section 2.4, Section 6 and Section 9 prior to the date of termination;

 

(ii) Gilead may elect to have the licenses granted to Gilead pursuant to Section 5.1 and the negative covenants of Achillion under Section 5.3 survive;

 

(iii) Gilead shall have no further diligence obligations under Sections 3.5 or 4.4;

 

(iv) If Gilead elects to have the licenses granted to Gilead pursuant to Section 5.1 survive, subject to Gilead’s rights to make claims against Achillion, Gilead’s obligations to Achillion under Section 6 shall survive;

 

(v) The obligations of the Parties under Sections 2 and 3 shall expire; and

 

(vi) Achillion shall assign and promptly transfer to Gilead, or its Affiliates as requested by Gilead, at no expense to Gilead or its Affiliates, all of Achillion’s right, title and interest in and to (A) all regulatory filings (such as INDs and drug master files), Regulatory Approvals, and clinical trial agreements (to the extent assignable and not cancelled) for the Licensed Product(s) or any Compounds, and (B) all data, including clinical data, materials and information of any kind or nature whatsoever, in Achillion’s possession or in the possession of its Affiliates or its or their respective agents related to the Licensed Product(s) or any Compounds.

 

(d) Return of Confidential Information. Upon expiration or termination of this Agreement the Parties shall comply with Section 7.1(b).

 

10.5 Accrued Rights and Obligations; Survival. Termination of this Agreement by a Party pursuant to Section 10.3 shall not be a Party’s sole remedy for a material breach of this Agreement but shall be in addition to any other rights or remedies of a Party under this Agreement Termination or expiration of this Agreement shall not affect any accrued rights or surviving obligations of the Parties. The provisions of Sections 2.5, 5.3(c), 6.9, 7, 8.3, 9, 10.4, 11 and 12 shall survive the expiration or termination of this Agreement for any reason whatsoever.

 

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11. INDEMNIFICATION, INSURANCE, LIMITATIONS OF LIABILITY

 

11.1 Indemnification by Gilead. Gilead will indemnify, hold harmless and defend Achillion, its Affiliates, and their respective employees and agents against any and all losses, damages, liabilities, judgments, fines, amounts paid in settlement, expenses and costs of defense (including without limitation reasonable attorneys’ fees and witness fees) ( “Losses” ) resulting from any claim, demand, suit, action or proceeding brought or initiated by a Third Party ( “Third Party Claim” ) against them to the extent that such Third Party Claim arises out of (i) the research, development, manufacture, use, sale or other commercialization of Licensed Products by Gilead, its Affiliates, sublicensees or distributors, including but not limited to infringement of Patents of Third Parties, or misappropriation of trade secrets of Third Parties, resulting from such activities (such Losses arising out of infringement of Patents, “Third Party Infringement Losses” ); (ii) the breach or alleged breach of any representation or warranty by Gilead in Section 8; or (iii) the negligence or willful misconduct of Gilead, its Affiliates, or their respective employees or agents in the course of performance under this Agreement; provided that such indemnity shall not apply to the extent Achillion has an indemnification obligation pursuant to Section 11.2 or 11.3 for such Loss.

 

11.2 Indemnification by Achillion. Achillion will indemnify, hold harmless and defend Gilead, its Affiliates and their respective employees and agents against any and all Losses resulting from any Third Party Claim against them to the extent that such Third Party Claim arises out of (i) the research, development, and other activities under this Agreement by Achillion, its Affiliates, and agents, excluding the infringement of Patents of Third Parties resulting from the research, development, manufacture, use, sale or other commercialization of Licensed Products by Gilead, its Affiliates, sublicensees or distributors; (ii) the breach or alleged breach of any representation or warranty by Achillion in Section 8 and (iii) the negligence or willful misconduct of Achillion, its Affiliates, or their respective employees (which for the purposes of Field Based Personnel shall mean such negligence or willful misconduct not directed by Gilead) or agents; provided that such indemnity shall not apply to the extent Gilead has an indemnification obligation pursuant to Section 11.1 or 11.3 for such Loss.

 

11.3 Product Liability

 

(a) Achillion will indemnify, hold harmless and defend Gilead, its Affiliates and their respective employees and agents against any and all Losses resulting from any Third Party product liability claim or any claim of bodily injury against them to the extent that such claim (i) arises from clinical studies conducted by Achillion pursuant to the Research Program; (ii) any action or inaction by Field-Based Personnel in violation of laws or regulations (except to the extent such action or inaction is directed by Gilead); or (iii) the gross negligence or willful misconduct of Achillion, its Affiliates, or their respective employees or agents to the extent that such gross negligence or willful misconduct is not related to the design of a Licensed Product

 

(b) Gilead will indemnify, hold harmless and defend Achillion, its Affiliates and their respective employees and agents against any and all Losses resulting from any Third Party product liability claim or any claim of bodily injury against them to the extent that such claim involves Compounds and is not covered by claims described in Section 11.2 or 11.3(a).

 

11.4 Mechanics. If a Party, its Affiliate, or any of their respective employees or agents has a right to be indemnified under this Section 11 (the “Indemnified Party” ), (a) such

 

41


Indemnified Party shall give thirty (30) days notice of such Third Party Claim to the other Party (the “Indemnifying Party” ) and (b) subject to Section 9.5, such Indemnifying Party shall have the first right to defend any such Third Party Claims, with the cooperation and at the expense of such Indemnifying Party, provided that the Indemnifying Party will not settle any such Third Party Claim without the prior written consent of the Indemnified Party, which consent shall not be unreasonably withheld, conditioned or delayed. If the Indemnifying Party does not wish to defend against a Third Party Claim, it shall so notify the Indemnified Party in writing and the Indemnified Party shall have the right to defend and settle such Third Party Claim, at the expense of the Indemnifying Party, subject to obtaining the Indemnifying Party’s consent to any settlement, such consent not to be unreasonably withheld, conditioned or delayed. If the Indemnifying Party is defending a Third Party Claim, the Indemnified Party shall have the right to be present in person or through counsel at substantive legal proceedings at its own expense, hi the event that the Parties cannot agree as to the application of Section 11.4 and to any Loss or Third Party Claim, the Parties may conduct separate defenses of such Third Party Claim. In such case, each Party further reserves the right to claim indemnity from the other in accordance with Sections 11.1 and 11.2 upon resolution of such underlying Third Party Claim.

 

11.5 Insurance Coverage. At all times during the term of this Agreement and any extended terms thereof, each Party represents and warrants that it will provide and maintain, at its own expense, adequate insurance coverage for a pharmaceutical company of similar situation. Such insurance shall include comprehensive general liability insurance. This coverage shall be provided by a carrier rated a minimum of AV by BEST Rating or its equivalent or by an adequately capitalized captive (in accordance with usual insurance standards), which covers all such Parry’s activities and obligations hereunder in accordance with reasonable pharmaceutical industry standards of companies; provided, however, that the amount of such insurance shall be not less than $5 million for each occurrence and $5 million aggregate for all occurrences. In addition, each Party shall carry products liability and/or clinical trials insurance in the amounts and for the periods that are appropriate in light of such Party’s activities pursuant to this Agreement. Should such coverage be written on a claims-made basis, each Party agrees to maintain coverage for a period of not less than five (5) years after the expiration of this Agreement. Each Party will provide to other Party with prior written notice upon any cancellation or material change in such insurance program. Upon request, each Party may receive a certificate of insurance evidencing insurance coverage.

 

11.6 Limitation Of Liability. Neither Party shall be liable to the other Party for incidental, consequential or special damages, including but not limited to lost profits, whether in contract, tort or otherwise, arising from or relating to any breach of or activities under this Agreement, regardless of any notice of the possibility of such damages. Nothing in this Section 11.6 is intended to limit or restrict the indemnification rights or obligations of any party under this Agreement.

 

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12. GENERAL PROVISIONS

 

12.1 Dispute Resolution; Governing Law

 

(a) Disputes

 

(i) The Parties recognize that disputes as to certain matters may from time to time arise during the term of this Agreement which relate to either Party’s rights and/or obligations hereunder. It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation and without resort to litigation. To accomplish this objective, the Parties agree to follow the procedures set forth in this Section 12.1 if and when a dispute arises under this Agreement.

 

(ii) In the event of disputes between the Parties, a Party seeking to resolve such dispute will, by written notice to the other, have such dispute referred to their respective executive officers designated below or their successors, for attempted resolution by good faith negotiations within [**] after such notice is received. Said designated officers are as follows:

 

For Achillion:

   Michael Kishbauch, President and Chief Executive Officer

For Gilead:

   John F. Milligan, Ph.D., Executive Vice President & CFO

 

(iii) In the event the designated executive officers are not able to resolve such dispute, either Party may at any time after the [**] period invoke the provisions of Section 12.1 hereinafter.

 

(b) Alternative Dispute Resolution. Following settlement efforts pursuant to Section 12.1 (a), any dispute, controversy or claim arising out of or relating to the validity, construction, enforceability or performance of this Agreement, including disputes relating to alleged breach or to termination of this Agreement under Section 10, other than disputes which are expressly prohibited herein from being resolved by this mechanism, shall be settled by binding alternative dispute resolution (“ ADR ”) in the manner described below:

 

(i) If a Party intends to begin an ADR to resolve a dispute, such Party shall provide written notice (the “ ADR Request ”) to counsel for the other Party, informing the other Party of such intention and the issues to be resolved.

 

(ii) Within [**] after the receipt of the ADR Request, the other Party may, by written notice to the counsel for the Party initiating ADR, add additional issues to be resolved.

 

(iii) Disputes regarding the scope, validity and enforceability of Patents shall not be subject to this Section 12.1, and shall be submitted to a court of competent jurisdiction.

 

(c) Arbitration Procedure. The ADR shall be conducted pursuant to the JAMS Rules then in effect, except that notwithstanding those rules, the following provisions shall apply to the ADR hereunder:

 

(i) The arbitration shall be conducted by a panel of three arbitrators (the “ Arbitration Panel ). The Arbitration Panel shall be selected from a pool of retired independent federal judges to be presented to the Parties by JAMS.

 

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(ii) The time periods set forth in the JAMS rules shall be followed, unless a Party can demonstrate to the Arbitration Panel that the complexity of the issues or other reasons warrant the extension of one or more of the time tables. In such case, the Arbitration Panel may extend such time tables, but in no event shall the time tables be extended so that the ADR proceeding extends more than 18 months from the date of the ADR Request. In regard to such time tables, the Parties (A) acknowledge that the issues that may arise in any dispute involving this Agreement may involve a number of complex matters and (B) confirm their intention that each Party will have the opportunity to conduct complete discovery with respect to all material issues involved in a dispute within the framework provided above. Within such timeframes, each Party shall have the right to conduct discovery in accordance with the Federal Rules of Civil Procedure. The Arbitration Panel shall not award punitive damages to either Party and the Parties shall be deemed to have waived any right to such damages. The Arbitration Panel shall in rendering its decision, apply the substantive law of the State of New York, except for any of its choice of law rules that would require the application of the laws of another jurisdiction, except that the interpretation of and enforcement of this Section 12.1 shall be governed by the Federal Arbitration Act. The Arbitration Panel shall apply the Federal Rules of Evidence to the hearing. In the event that arbitration is initiated by Gilead, the hearing shall convene in Boston, MA; in the event that arbitration is initiated by Achillion, the hearing shall convene in San Francisco, CA. The fees of the Arbitration Panels and JAMS shall be paid by the losing Party which shall be designated by the Arbitration Panel. If the Arbitration Panel is unable to designate a losing Party, it shall so state and the fees shall be split equally between the Parties.

 

(iii) The Arbitration Panel is empowered to award any remedy allowed by law, including money damages, prejudgment interest and attorneys’ fees, and to grant final, complete, interim, or interlocutory relief, including injunctive relief but excluding punitive damages.

 

(iv) Except as set forth in Section 12.1(c)(ii), above, each Party shall bear its own legal fees and expenses against the Party losing the ADR unless it believes that neither Party is the clear loser, in which case the Arbitration Panel shall divide such fees, costs and expenses according to the Arbitration Panel’s sole discretion.

 

(v) The ADR proceeding shall be confidential and the Arbitration Panel shall issue appropriate protective orders to safeguard each Party’s Confidential Information. Except as required by law, no Party shall make (or instruct the Arbitration Panel to make) any public announcement with respect to the proceedings or decision of the Arbitration Panel without prior written consent of each other Party. The existence of any dispute submitted to ADR, and the award, shall be kept in confidence by the Parties and the Arbitration Panel, except as required in connection with the enforcement of such award or as otherwise required by applicable law.

 

(d) Judicial Enforcement. The Parties agree that judgement on any arbitral award issued pursuant to this Section 12 shall be entered in the United States District Court for the Northern District of California or, in the event such court does not have subject matter jurisdiction over the dispute in question, such judgment shall be entered in the Superior Court of the State of California, in the County of San Mateo.

 

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(e) Governing Law. This Agreement shall be governed and construed in accordance with the laws of the State of New York, except for any of its choice of law rules that would require the application of the laws of another jurisdiction.

 

12.2 Jurisdiction and Venue. In connection with any dispute arising hereunder or in connection with the subject matter hereof that is not settled in accordance with Section 12.1, each of the Parties hereby consents to the non-exclusive jurisdiction and venue of the U.S. federal courts located within the state of California and of the California state courts. Each Party hereby irrevocably waives any right that it may have to assert that any such court lacks jurisdiction or that such forum is not convenient.

 

12.3 Language. The official text of this Agreement and any exhibits referenced herein, or any notice given or accounts or statements required by this Agreement shall be in English. In the event of any dispute concerning the construction or meaning of this Agreement, reference shall be made only to this Agreement as written in English and not to any other translation into any other language.

 

12.4 Compliance with Laws. Each Party shall carry out its activities pursuant to this Agreement in compliance with all applicable supranational, national, state, provincial and other local laws, rules, regulations and guidelines.

 

12.5 Notice. All notices hereunder shall be in writing and shall be delivered personally, sent for next day delivery by internationally recognized courier service or transmitted by facsimile (transmission confirmed), with confirmation by next day delivery by an internationally recognized courier service, to the following addresses and facsimiles of the respective Parties or such other address or facsimile as is notified pursuant to this Section 12.5:

 

Gilead:

   Gilead Sciences, Inc.
     333 Lakeside Drive
     Foster City, CA 94404
     Attention: Executive Vice President and Chief Financial Officer
     Fax No.: (650) 522-5488

with a copy to:

   Gilead Sciences, Inc.
     333 Lakeside Drive
     Foster City, CA 94404
     Attention: Vice President and General Counsel
     Fax No.: (650) 522-5537

Achillion:

   Achillion Pharmaceuticals, Inc.
     300 George Street
     New Haven, Connecticut 06511
     Attention: Chief Executive Officer
     Fax: (203) 624-7003

 

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with copies to:

   Achillion Pharmaceuticals, Inc.
     300 George Street
     New Haven, Connecticut 06511
     Attention: Vice President of Finance
     Fax: (203) 624-7003
     Steven D. Singer
     Wilmer Cutler Pickering Hale and Dorr
     60 State Street
     Boston, MA 02109
     Fax: (617) 526-5000

 

12.6 Waiver. The failure on the part of a Party to exercise or enforce any rights conferred upon it hereunder shall not be deemed to be a waiver of any such rights nor operate to bar the exercise or enforcement thereof at any time or times hereafter.

 

12.7 Assignment. Except as otherwise provided in this Section 12.7, neither Party will assign its rights or duties under this Agreement to any Third Party without the prior express written consent of the other Party, which shall not be unreasonably withheld. Any purported assignment not in compliance with this Section 12.7 will be void.

 

(a) Gilead Change of Corporate Control. Gilead may, without Achillion’s consent, assign this Agreement and its rights and obligations hereunder in connection with a Change of Corporate Control.

 

(b) Achillion Change of Corporate Control. Achillion may, without Gilead’s consent, assign this Agreement and its rights and obligations hereunder in connection with a Change of Corporate Control, subject to the conditions contained in this Section 12.7(b). Upon a Change of Corporate Control of Achillion, Achillion shall provide written notice to Gilead [**] prior to such assignment, which notice shall specify the identity of the acquirer in the Change of Corporate Control. If Achillion so notifies Gilead, and the entity obtaining Corporate Control of Achillion is either an entity engaged in the pharmaceutical or biotechnology business, with a market capitalization of at least $[**] U.S. Dollars, or an entity engaged in the development or commercialization of products in the HCV Field, Gilead shall have the right, at its election at any time within [**] after such notice, to elect in a written notice to Achillion, to do any or all of the following:

 

(i) terminate the provisions of Section 2 and/or Sections 3.1-3.4, in whole or in part;

 

(ii) terminate Achillion’s participation in Gilead’s commercial activities pursuant to Section 4.2(b); and/or

 

(iii) disband the Research Committee, the Development Committee, or both such Committees.

 

If Gilead makes any of the foregoing elections, the Parties shall within [**] after any such election determine, if applicable, any amounts due pursuant to Section 2.4 and pay such amounts, and Achillion shall assign and transfer to Gilead, or its Affiliates as requested by Gilead, all of

 

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Achillion’s right, title and interest in and to (A) all regulatory filings (such as INDs and drug master files), Regulatory Approvals, and clinical trial agreements (to the extent assignable and not cancelled) for the Licensed Product(s) or any Compounds; and (B) all data, including clinical data, materials and information of any kind or nature whatsoever, in Achillion’s possession or in the possession of its Affiliates or its or their respective agents related to the Licensed Product(s) or any Compounds.

 

12.8 Performance by Affiliates. A Party’s obligations under this Agreement may be performed by its Affiliates. Obligations of the Party for which one of its Affiliates is performing hereunder shall be deemed to extend to such performing Affiliate. Each Party guarantees performance of this Agreement by its Affiliates. Wherever in this Agreement the Parties delegate responsibility to Affiliates or local operating entities, the Parties agree that such entities shall not make decisions inconsistent with this Agreement, amend the terms of this Agreement or act contrary to its terms in any way.

 

12.9 Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by a bankrupt Party to the other Party are, and shall be deemed to be, for purposes of Section 365(n) of the Bankruptcy Code and any similar law or regulation in any other country, licenses of rights to “intellectual property” as defined under Section 101(35A) of the Bankruptcy Code. The Parties agree that all intellectual property rights licensed hereunder are part of the “intellectual property” as defined under Section 1O1(35A) of the Bankruptcy Code subject to the protections afforded the non-terminating Party under Section 365(n) of the Bankruptcy Code, and any similar law or regulation in any other country.

 

12.10 Severability. The provisions of this Agreement are severable. If any item or provision of this Agreement shall to any extent be invalid or unenforceable, the remainder of this Agreement shall not be affected thereby, and each term and provision of this Agreement shall be valid and shall be enforced to the fullest extent permitted by law. The Parties will use diligent good faith efforts to revise this Agreement as and to the extent reasonably necessary to effectuate their original intent and purpose under this Agreement.

 

12.11 Force Majeure. Neither Party shall be liable for any delay or failure of performance to the extent such delay or failure is caused by circumstances beyond its reasonable control and that by exercise of due diligence it is unable to prevent, provided that the Party claiming excuse immediately notifies the other Party and uses and continues to use commercially reasonable efforts to overcome the same.

 

12.12 Entire Agreement; Modification. This Agreement, including any exhibits expressly named and referenced herein, constitutes the entire agreement and understanding of the Parties and supersedes any prior agreements or understandings relating to the subject matter hereof. Any modification of this Agreement shall be effective only to the extent it is reduced to writing and signed by a duly authorized representative of each Party hereto.

 

12.13 Headings. The captions to the several Articles and Sections hereof are not a part of this Agreement, but are merely for convenience to assist in locating and reading the several Articles and Sections hereof.

 

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12.14 Independent Contractors. It is expressly agreed that Gilead and Achillion shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither Gilead nor Achillion shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other Party, without the prior written consent of the other Party.

 

12.15 Cumulative Remedies. No remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under law.

 

12.16 Counterparts. This Agreement may be executed in one or more counterparts, each of which shall be an original and all of which shall constitute together the same document.

 

The persons executing this Agreement represent and warrant that they have the full power and authority to cause their respective entities to enter into this Agreement.

 

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IN WITNESS WHEREOF the Parties have executed this agreement as of the effective date by their duly authorized representatives.

 

ACHILLION PHARMACEUTICALS, INC.

     

GILEAD SCIENCES, INC.

By:

 

/s/ Michael Kishbauch

     

By:

 

/s/ John F. Milligan

Name:

 

Michael Kishbauch

     

Name:

 

John F. Milligan, Ph.D.

Title:

 

President & CEO

     

Title:

 

Executive Vice President & CFO


EXHIBIT 1.1: ACHILLION PATENTS AND PATENT APPLICATIONS:

 

US Patent Application Serial No. [**]

 

[**]

 

US Provisional Patent Application Serial No. [**]

 

US Provisional Patent Application Serial No. [**]

 

US Patent Application Serial No. [**]

 

[**]


EXHIBIT 1.2: COMPOUNDS

 

Compound means each of the following:

 

(i) [**] as claimed under Achillion Patents and patent applications as listed in Exhibit 1.1;

 

(ii) any compound [**]; or

 

(iii) any [**] prior to the end of the term of the Agreement, [**]. For purposes of clarification of this clause (iii), “Compounds” included in this clause (iii) [**].


EXHIBIT 1.3: PROOF OF CONCEPT

 

“Proof of Concept” means:

 

Demonstration of [**].

 

A clinical study of suitable design approved by the Research Committee [**] by either Gilead or Achillion from the contract research organization(s) implementing the study.


EXHIBIT 2.2: PROOF-OF-CONCEPT CLINICAL DEVELOPMENT PLAN

 

Studies prior to Phase 1 [**]

 

Non-clinical studies [**]. The criteria [**] will be determined.

 

Phase la Studies [**]

 

The Phase 1 study [**] will be studied. Specific parameters needed for advancement to the “proof of principle” study will be determined prior to initiation of the study.

 

Phase lb [**]

 

This study will [**] into longer-term studies. This study will [**]. This study will [**] and will be agreed to by the Research Committee. [**]. The parties will agree [**].


RESEARCH PROGRAM:

 

PROOF-OF-CONCEPT PROGRAM

 

Objectives for Proof-of-Concept Program:

 

[**]


RESEARCH PROGRAM:

 

PROOF-OF-CONCEPT PROGRAM RESOURCE ALLOCATION

 

Internal Costs

 

CATEGORY


   FTEs

   ACH FTEs

   GILD FTEs

   Internal Costs

IND-enabling pre-clinical

   [**]    [**]    [**]    $ [**]

Phase 1 PK/Safety Trial

   [**]    [**]    [**]    $ [**]

Phase lb/2 PoC Trial

   [**]    [**]    [**]    $ [**]

Manufacturing / Formulation

   [**]    [**]    [**]    $ [**]

R&D Management

   [**]    [**]    [**]    $ [**]

Totals

   [**]    [**]    [**]    $ [**]

 

External Costs

 

CATEGORY


    

IND-enabling pre-clinical

   $ [**]

Phase 1 PK/Safety Trial

   $ [**]

Phase lb/2 PoC Trial

   $ [**]

Manufacturing / Formulation

   $ [**]

Total

   $ [**]

 

Total Costs

 

CATEGORY


   INTERNAL

   EXTERNAL

   Total Costs

IND-enabling pre-clinical

   $ [**]    $ [**]    $ [**]

Phase 1 PK/Safety Trial

   $ [**]    $ [**]    $ [**]

Phase lb/2 PoC Trial

   $ [**]    $ [**]    $ [**]

Manufacturing / Formulation

   $ [**]    $ [**]    $ [**]

R&D Management

   $ [**]    $ [**]    $ [**]

POC Program Budget

   $ [**]    $ [**]    $ [**]


RESEARCH PROGRAM:

 

BACK-UP PROGRAM

 

Research Objectives for Backup Program

 

[**]


RESEARCH PROGRAM:

 

BACK-UP PROGRAM RESOURCE ALLOCATION

 

Activity


   Achillion FTEs

  Duration

VIROLOGY

        

•      [**]

   [**]   [**]

MECHANISM OF ACTION

        

•      [**]

   [**]   [**]
In vitro / In vivo Profiling and Bioanalytics    [**]   [**]

CHEMISTRY

        

•      [**]

   [**]   [**]

 

Back-up Program Cost

 

CATEGORY


   ACH
FTEs


   Internal

   External

   Total

Virology

   [**]    $ [**]              

Mechanism of Action

   [**]    $ [**]              

Profiling and Bioanalytics

   [**]    $ [**]              

Chemistry

   [**]    $ [**]              

Total

        $ [**]    $ [**]    $ [**]


RESEARCH PROGRAM COST CAP

 

CATEGORY


   INTERNAL

   EXTERNAL

   Total Costs

Research Program

   $ [**]    $ [**]    $ [**]

 

COSTS BY RESEARCH PROGRAM

 

CATEGORY


   INTERNAL

   EXTERNAL

   Total Costs

POC Program Budget

                    

IND-enabling pre-clinical

   $ [**]    $ [**]    $ [**]

Phase I PK/Safety Trial

   $ [**]    $ [**]    $ [**]

Phase 1b/2 PoC Trial

   $ [**]    $ [**]    $ [**]

Manufacturing/Formulation

   $ [**]    $ [**]    $ [**]

R&D Management

   $ [**]    $ [**]    $ [**]
     $ [**]    $ [**]    $ [**]

Back-Up Program Cost

                    

Virology

   $ [**]              

Mechanism of Action

   $ [**]              

Profiling and Bioanalytics

   $ [**]              

Chemistry

   $ [**]              
     $ [**]    $ [**]    $ [**]

Total

   $ [**]    $ [**]    $ [**]


EXHIBIT 7.4: PRESS RELEASE

 

Gilead Contacts:    Achillion Contacts:

Amy Flood, Media

   Kari Lampka, Media

(650) 522-5643

   (508) 647-0209

Susan Hubbard, Investors

   Mary Kay Fenton, Investors

(650) 522-5715

   (203) 624-7000

 

DRAFT - NOT FOR RELEASE

 

GILEAD AND ACHILLION ANNOUNCE COLLABORATION FOR THE DEVELOPMENT AND COMMERCIALIZATION OF ACHILLION’S HEPATITIS C COMPOUNDS

 

Foster City, CA and New Haven, CT, November XX, 2004 - Gilead Sciences (Nasdaq: GILD) and Achillion Pharmaceuticals today announced that the companies have signed an exclusive agreement granting Gilead worldwide rights for the research, development and commercialization of certain Achillion compounds for the treatment of infection with the hepatitis C virus (HCV). The compounds, small molecule inhibitors of HCV replication, are believed to act through a novel mechanism of action involving HCV protease. In this collaboration, Achillion will continue development of the compounds, according to a mutually agreed upon development plan, through completion of a proof-of-concept clinical study in HCV-infected patients. Following the proof-of-concept study, Gilead will assume full responsibilities and costs associated with development and commercialization for compounds warranting further development.

 

Under the terms of the agreement, Gilead will pay to Achillion a $5 million upfront license payment and will purchase $5 million of equity. In addition, Gilead will provide partial funding through the completion of the proof-of-concept study. Achillion could also earn milestone payments in excess of $100 million under the agreement, based upon the achievement of certain development, regulatory and commercial goals, and will have the option to participate in U.S. commercialization efforts for any future products arising from this collaboration. Achillion’s milestone payments could increase substantially assuming progress is made on multiple related compounds. Gilead will receive exclusive worldwide license rights and will pay Achillion a royalty on net sales of future products arising from the collaboration.

 

“Gilead and Achillion share a commitment to developing advanced therapeutics for the treatment of significant unmet medical needs, such as HCV,” said John C. Martin, Ph.D., President and Chief Executive Officer of Gilead Sciences. “Achillion’s drug discovery and development expertise, particularly in identifying unique drug targets with the potential to address drug resistance, makes the company an ideal partner for Gilead. We believe Achillion’s compounds work through a novel mechanism, making them excellent potential candidates for HCV combination therapy regimens. We look forward to collaborating with Achillion to rapidly advance new compounds for the treatment of HCV.”

 

“This collaboration highlights the strength of Achillion’s discovery and development capabilities and its ability not only to create important new compounds for treatment of life-threatening


infectious diseases, but also to advance such compounds into clinical proof-of-concept studies. Gilead’s commercial franchise and expertise in antiviral drug development has made the company our strongly preferred partner to advance and commercialize compounds from our exciting HCV program,” stated Michael Kishbauch, Chief Executive Officer of Achillion. “We believe that this agreement provides an important catalyst to this program while also freeing up resources to advance our own HIV and antibacterial programs.”

 

Hepatitis C is a viral liver disease, caused by infection with the hepatitis C virus. Globally, more than 170 million people have chronic hepatitis C. About 3 million Americans are now estimated to be chronically infected with the hepatitis C virus. HCV is a leading cause of cirrhosis, a common cause of hepatocellular carcinoma, and is the leading cause of liver transplantation in the United States.

 

ABOUT GlLEAD SCIENCES

 

Gilead Sciences, Inc. is a biopharmaceutical company that discovers, develops and commercializes therapeutics to advance the care of patients suffering from life-threatening diseases worldwide. The company has seven marketed products, and focuses its research and clinical programs on anti-infectives. Headquartered in Foster City, CA, Gilead has operations in North America, Europe and Australia.

 

About Achillion

 

Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. The company’s proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease—HIV, hepatitis and resistant bacterial infections.

 

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including risks related to the companies’ ability to move compounds into the clinic and to successfully discover, develop and/or commercialize any compounds under the agreement. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in the Gilead Annual Report on Form 10-K for the year ended December 31, 2003 and in the company’s Quarterly Reports on Form 10-Q, which are on file with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and neither company assumes any obligation to update any such forward-looking statements.

 

# # #

 

For more information on Gilead Sciences, please visit the company’s web site at

www.gilead.com or call the Gilead Public Affairs Department at

1-800-GILEAD-5 or 1-650-574-3000.

 

For more information on Achillion Pharmaceuticals, please visit the company’s web site at

www.achillion.com or call Achillion at 1-203-624-7000.

Exhibit 10.18

 

ACHILLION PHARMACEUTICALS, INC.

 

2006 STOCK INCENTIVE PLAN

 

1. Purpose

 

The purpose of this 2006 Stock Incentive Plan (the “Plan”) of Achillion Pharmaceuticals, Inc., a Delaware corporation (the “Company”), is to advance the interests of the Company’s stockholders by enhancing the Company’s ability to attract, retain and motivate persons who are expected to make important contributions to the Company and by providing such persons with equity ownership opportunities and performance-based incentives that are intended to align their interests with those of the Company’s stockholders. Except where the context otherwise requires, the term “Company” shall include any of the Company’s present or future parent or subsidiary corporations as defined in Sections 424(e) or (f) of the Internal Revenue Code of 1986, as amended, and any regulations promulgated thereunder (the “Code”) and any other business venture (including, without limitation, joint venture or limited liability company) in which the Company has a controlling interest, as determined by the Board of Directors of the Company (the “Board”).

 

2. Eligibility

 

All of the Company’s employees, officers, directors, consultants and advisors are eligible to receive options, stock appreciation rights, restricted stock, restricted stock units and other stock-based awards (each, an “Award”) under the Plan. Each person who receives an Award under the Plan is deemed a “Participant”.

 

3. Administration and Delegation

 

(a) Administration by Board of Directors . The Plan will be administered by the Board. The Board shall have authority to grant Awards and to adopt, amend and repeal such administrative rules, guidelines and practices relating to the Plan as it shall deem advisable. The Board may construe and interpret the terms of the Plan and any Award agreements entered into under the Plan. The Board may correct any defect, supply any omission or reconcile any inconsistency in the Plan or any Award in the manner and to the extent it shall deem expedient to carry the Plan into effect and it shall be the sole and final judge of such expediency. All decisions by the Board shall be made in the Board’s sole discretion and shall be final and binding on all persons having or claiming any interest in the Plan or in any Award. No director or person acting pursuant to the authority delegated by the Board shall be liable for any action or determination relating to or under the Plan made in good faith.

 

(b) Appointment of Committees . To the extent permitted by applicable law, the Board may delegate any or all of its powers under the Plan to one or more committees or

 

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subcommittees of the Board (a “Committee”). All references in the Plan to the “Board” shall mean the Board or a Committee of the Board or the officers referred to in Section 3(c) to the extent that the Board’s powers or authority under the Plan have been delegated to such Committee or officers.

 

(c) Delegation to Officers . To the extent permitted by applicable law, the Board may delegate to one or more officers of the Company the power to grant Awards to employees or officers of the Company or any of its present or future subsidiary corporations and to exercise such other powers under the Plan as the Board may determine, provided that the Board shall fix the terms of the Awards to be granted by such officers (including the exercise price of such Awards, which may include a formula by which the exercise price will be determined) and the maximum number of shares subject to Awards that the officers may grant; provided further, however, that no officer shall be authorized to grant Awards to any “executive officer” of the Company (as defined by Rule 3b-7 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) or to any “officer” of the Company (as defined by Rule 16a-1 under the Exchange Act).

 

4. Stock Available for Awards

 

(a) Number of Shares . Subject to adjustment under Section 9, Awards may be made under the Plan for up to the number of shares of common stock, $.001 par value per share, of the Company (the “Common Stock”) that is equal to the sum of:

 

(1) Six million (6,000,000) shares of Common Stock; plus

 

(2) an annual increase to be added on the first day of each of the Company’s fiscal years during the period beginning in fiscal year 2007 and ending on the second day of fiscal year 2010 equal to the lowest of (i) 6,000,000 shares of Common Stock, (ii) the number of shares of Common Stock that, when added to the number of shares of Common Stock already reserved under the Plan, equals 5% of the outstanding shares of the Company on such date or (iii) an amount determined by the Board.

 

Notwithstanding clause (2) above, in no event shall the number of shares available under this Plan be increased as set forth in clause (2) to the extent such increase, in addition to any other increases proposed by the Board in the number of shares available for issuance under all other employee or director stock plans, would result in the total number of shares then available for issuance under all employee and director stock plans exceeding 20% of the outstanding shares of the Company on the first day of the applicable fiscal year.

 

If any Award expires or is terminated, surrendered or canceled without having been fully exercised or is forfeited in whole or in part (including as the result of shares of Common Stock subject to such Award being repurchased by the Company at the original issuance price pursuant to a contractual repurchase right), is settled in cash or results in any Common Stock not being issued, the unused Common Stock covered by such Award shall again be available for the grant of Awards under the Plan. Further, shares of Common Stock tendered to the Company by a

 

-2-


Participant to exercise an Award shall be added to the number of shares of Common Stock available for the grant of Awards under the Plan. However, in the case of Incentive Stock Options (as hereinafter defined), the foregoing provisions shall be subject to any limitations under the Code. Shares issued under the Plan may consist in whole or in part of authorized but unissued shares or treasury shares.

 

(b) Per-Participant Limit . Subject to adjustment under Section 9, for Awards granted after the Common Stock is registered under the Securities Exchange Act of 1934 (the “Exchange Act”), the maximum number of shares of Common Stock with respect to which Awards may be granted to any Participant under the Plan shall be 750,000 per calendar year. For purposes of the foregoing limit, the combination of an Option in tandem with an SAR (as each is hereafter defined) shall be treated as a single Award. The per-Participant limit described in this Section 4(b) shall be construed and applied consistently with Section 162(m) of the Code or any successor provision thereto, and the regulations thereunder (“Section 162(m)”).

 

(c) Substitute Awards . In connection with a merger or consolidation of an entity with the Company or the acquisition by the Company of property or stock of an entity, the Board may grant Awards in substitution for any options or other stock or stock-based awards granted by such entity or an affiliate thereof. Substitute Awards may be granted on such terms as the Board deems appropriate in the circumstances, notwithstanding any limitations on Awards contained in the Plan. Substitute Awards shall not count against the overall share limit set forth in Section 4(a), except as may be required by reason of Section 422 and related provisions of the Code.

 

5. Stock Options

 

(a) General . The Board may grant options to purchase Common Stock (each, an “Option”) and determine the number of shares of Common Stock to be covered by each Option, the exercise price of each Option and the conditions and limitations applicable to the exercise of each Option, including conditions relating to applicable federal or state securities laws, as it considers necessary or advisable. An Option that is not intended to be an Incentive Stock Option (as hereinafter defined) shall be designated a “Nonstatutory Stock Option”.

 

(b) Incentive Stock Options . An Option that the Board intends to be an “incentive stock option” as defined in Section 422 of the Code (an “Incentive Stock Option”) shall only be granted to employees of Achillion Pharmaceuticals, Inc., any of Achillion, Pharmaceuticals, Inc.’s present or future parent or subsidiary corporations as defined in Sections 424(e) or (f) of the Code, and any other entities the employees of which are eligible to receive Incentive Stock Options under the Code, and shall be subject to and shall be construed consistently with the requirements of Section 422 of the Code. The Company shall have no liability to a Participant, or any other party, if an Option (or any part thereof) that is intended to be an Incentive Stock Option is not an Incentive Stock Option or for any action taken by the Board, including without limitation the conversion of an Incentive Stock Option to a Nonstatutory Stock Option.

 

-3-


(c) Exercise Price . The Board shall establish the exercise price of each Option and specify such exercise price in the applicable option agreement; provided, however, that the exercise price shall not be less than 100% of the Fair Market Value (as defined below) on the date the Option is granted.

 

(d) Duration of Options . Each Option shall be exercisable at such times and subject to such terms and conditions as the Board may specify in the applicable option agreement.

 

(e) Exercise of Option . Options may be exercised by delivery to the Company of a written notice of exercise signed by the proper person or by any other form of notice (including electronic notice) approved by the Board together with payment in full as specified in Section 5(f) for the number of shares for which the Option is exercised. Shares of Common Stock subject to the Option will be delivered by the Company following exercise either as soon as practicable or, subject to such conditions as the Board shall specify, on a deferred basis (with the Company’s obligation to be evidenced by an instrument providing for future delivery of the deferred shares at the time or times specified by the Board).

 

(f) Payment Upon Exercise. Common Stock purchased upon the exercise of an Option granted under the Plan shall be paid for as follows:

 

(1) in cash or by check, payable to the order of the Company;

 

(2) except as may otherwise be provided in the applicable option agreement, by (i) delivery of an irrevocable and unconditional undertaking by a creditworthy broker to deliver promptly to the Company sufficient funds to pay the exercise price and any required tax withholding or (ii) delivery by the Participant to the Company of a copy of irrevocable and unconditional instructions to a creditworthy broker to deliver promptly to the Company cash or a check sufficient to pay the exercise price and any required tax withholding;

 

(3) to the extent provided for in the applicable option agreement or approved by the Board, in its sole discretion, by delivery (either by actual delivery or attestation) of shares of Common Stock owned by the Participant valued at their fair market value as determined by (or in a manner approved by) the Board (“Fair Market Value”), provided (i) such method of payment is then permitted under applicable law, (ii) such Common Stock, if acquired directly from the Company, was owned by the Participant for such minimum period of time, if any, as may be established by the Board in its discretion and (iii) such Common Stock is not subject to any repurchase, forfeiture, unfulfilled vesting or other similar requirements;

 

(4) to the extent permitted by applicable law and provided for in the applicable option agreement or approved by the Board in its sole discretion, by (i) delivery of a promissory note of the Participant to the Company on terms determined by the Board or (ii) payment of such other lawful consideration as the Board may determine; or

 

(5) by any combination of the above permitted forms of payment.

 

-4-


(g) Repricing . The Board may, without stockholder approval, amend any outstanding Option granted under the Plan to provide an exercise price per share that is lower than the then-current exercise price per share of such outstanding Option. The Board may also, without stockholder approval, cancel any outstanding option (whether or not granted under the Plan) and grant in substitution therefor new Awards under the Plan covering the same or a different number of shares of Common Stock and having an exercise price per share lower than the then-current exercise price per share of the cancelled option.

 

6. Stock Appreciation Rights .

 

(a) General . The board may grant Awards consisting of a Stock Appreciation Right (“SAR”), entitling the holder, upon exercise, to receive an amount of Common Stock or cash or a combination thereof (such form to be determined by the Board) determined by reference to appreciation, from and after the date of grant, in the fair market value of a share of Common Stock. The date as of which such appreciation or other measure is determined shall be the exercise date.

 

(b) Grants . Stock Appreciation Rights may be granted in tandem with, or independently of, Options granted under the Plan.

 

(1) Tandem Awards . When Stock Appreciation Rights are expressly granted in tandem with Options, (i) the Stock Appreciation Right will be exercisable only at such time or times, and to the extent, that the related Option is exercisable (except to the extent designated by the Board in connection with a Reorganization Event) and will be exercisable in accordance with the procedure required for exercise of the related Option; (ii) the Stock Appreciation Right will terminate and no longer be exercisable upon the termination or exercise of the related Option, except to the extent designated by the Board in connection with a Reorganization Event and except that a Stock Appreciation Right granted with respect to less than the full number of shares covered by an Option will not be reduced until the number of shares as to which the related Option has been exercised or has terminated exceeds the number of shares not covered by the Stock Appreciation Right; (iii) the Option will terminate and no longer be exercisable upon the exercise of the related Stock Appreciation Right; and (iv) the Stock Appreciation Right will be transferable only with the related Option.

 

(2) Independent SARs . A Stock Appreciation Right not expressly granted in tandem with an Option will become exercisable at such time or times, and on such conditions, as the Board may specify in the SAR Award.

 

(c) Grant Price . The Board shall establish the grant price or exercise price of each SAR and specify such price in the applicable Award agreement; provided, however, that the grant price or exercise price of an SAR shall not be less than 100% of the Fair Market Value per share of Common Stock on the date of grant of the SAR.

 

(d) Term . Each SAR shall be exercisable at such times and subject to such terms and conditions as the Board may specify in the applicable Award agreement.

 

-5-


(e) Exercise . Stock Appreciation Rights may be exercised by delivery to the Company of a written notice of exercise signed by the proper person or by any other form of notice (including electronic notice) approved by the Board, together with any other documents required by the Board.

 

7. Restricted Stock; Restricted Stock Units

 

(a) General . The Board may grant Awards entitling recipients to acquire shares of Common Stock (“Restricted Stock”), subject to the right of the Company to repurchase all or part of such shares at their issue price or other stated or formula price (or to require forfeiture of such shares if issued at no cost) from the recipient in the event that conditions specified by the Board in the applicable Award are not satisfied prior to the end of the applicable restriction period or periods established by the Board for such Award. Instead of granting Awards for Restricted Stock, the Board may grant Awards entitling the recipient to receive shares of Common Stock to be delivered at the time such shares of Common Stock vest (“Restricted Stock Units”) (Restricted Stock and Restricted Stock Units are each referred to herein as a “Restricted Stock Award”).

 

(b) Terms and Conditions for all Restricted Stock Awards . The Board shall determine the terms and conditions of a Restricted Stock Award, including the conditions for vesting and repurchase (or forfeiture) and the issue price, if any.

 

(c) Additional Provisions Relating to Restricted Stock .

 

(1) Dividends . Participants holding shares of Restricted Stock will be entitled to all ordinary cash dividends paid with respect to such shares, unless otherwise provided by the Board. If any such dividends or distributions are paid in shares, or consist of a dividend or distribution to holders of Common Stock other than an ordinary cash dividend, the shares, cash or other property will be subject to the same restrictions on transferability and forfeitability as the shares of Restricted Stock with respect to which they were paid. Each dividend payment will be made no later than the end of the calendar year in which the dividends are paid to shareholders of that class of stock or, if later, the 15th day of the third month following the date the dividends are paid to shareholders of that class of stock.

 

(2) Stock Certificates . The Company may require that any stock certificates issued in respect of shares of Restricted Stock shall be deposited in escrow by the Participant, together with a stock power endorsed in blank, with the Company (or its designee). At the expiration of the applicable restriction periods, the Company (or such designee) shall deliver the certificates no longer subject to such restrictions to the Participant or if the Participant has died, to the beneficiary designated, in a manner determined by the Board, by a Participant to receive amounts due or exercise rights of the Participant in the event of the Participant’s death (the “Designated Beneficiary”). In the absence of an effective designation by a Participant, “Designated Beneficiary” shall mean the Participant’s estate.

 

-6-


(d) Additional Provisions Relating to Restricted Stock Units .

 

(1) Settlement . Upon the vesting of and/or lapsing of any other restrictions (i.e., settlement) with respect to each Restricted Stock Unit, the Participant shall be entitled to receive from the Company one share of Common Stock or an amount of cash equal to the Fair Market Value of one share of Common Stock, as provided in the applicable Award agreement. The Board may, in its discretion, provide that settlement of Restricted Stock Units shall be deferred, on a mandatory basis or at the election of the Participant.

 

(2) Voting Rights . A Participant shall have no voting rights with respect to any Restricted Stock Units.

 

(3) Dividend Equivalents . To the extent provided by the Board, in its sole discretion, a grant of Restricted Stock Units may provide Participants with the right to receive an amount equal to any dividends or other distributions declared and paid on an equal number of outstanding shares of Common Stock (“Dividend Equivalents”). Dividend Equivalents may be paid currently or credited to an account for the Participants, may be settled in cash and/or shares of Common Stock and may be subject to the same restrictions on transfer and forfeitability as the Restricted Stock Units with respect to which paid, as determined by the Board in its sole discretion, subject in each case to such terms and conditions as the Board shall establish, in each case to be set forth in the applicable Award agreement.

 

8. Other Stock Unit Awards

 

Other Awards of shares of Common Stock, and other Awards that are valued in whole or in part by reference to, or are otherwise based on, shares of Common Stock or other property, may be granted hereunder to Participants (“Other Stock Unit Awards”), including without limitation Awards entitling recipients to receive shares of Common Stock to be delivered in the future. Such Other Stock Unit Awards shall also be available as a form of payment in the settlement of other Awards granted under the Plan or as payment in lieu of compensation to which a Participant is otherwise entitled. Other Stock Unit Awards may be paid in shares of Common Stock or cash, as the Board shall determine. Subject to the provisions of the Plan, the Board shall determine the terms and conditions of each Other Stock Unit Award, including any purchase price applicable thereto.

 

9. Adjustments for Changes in Common Stock and Certain Other Events .

 

(a) Changes in Capitalization . In the event of any stock split, reverse stock split, stock dividend, recapitalization, combination of shares, reclassification of shares, spin-off or other similar change in capitalization or event, or any distribution to holders of Common Stock other than an ordinary cash dividend, (i) the number and class of securities available under this Plan, (ii) the per-Participant limit set forth in Section 4(b), (iii) the number and class of securities and exercise price per share of each outstanding Option, (iv) the share- and per-share provisions and the exercise price of each Stock Appreciation Right, (v) the number of shares subject to and the repurchase price per share subject to each outstanding Restricted Stock Award, and (vi) the share- and per-share-related provisions and the purchase price, if any, of each outstanding Other

 

-7-


Stock Unit Award, shall be appropriately adjusted by the Company (or substituted Awards may be made, if applicable) to the extent determined by the Board.

 

(b) Reorganization Events

 

(1) Definition . A “Reorganization Event” shall mean: (a) any merger or consolidation of the Company with or into another entity as a result of which all of the Common Stock of the Company is converted into or exchanged for the right to receive cash, securities or other property or is cancelled, (b) any exchange of all of the Common Stock of the Company for cash, securities or other property pursuant to a share exchange transaction or (c) any liquidation or dissolution of the Company.

 

(2) Consequences of a Reorganization Event on Awards Other than Restricted Stock Awards . In connection with a Reorganization Event, the Board shall take any one or more of the following actions as to all or any outstanding Awards other than Restricted Stock Awards on such terms as the Board determines: (i) provide that Awards shall be assumed, or substantially equivalent Awards shall be substituted, by the acquiring or succeeding corporation (or an affiliate thereof), (ii) upon written notice to a Participant, provide that the Participant’s unexercised Options or other unexercised Awards will terminate immediately prior to the consummation of such Reorganization Event unless exercised by the Participant within a specified period following the date of such notice, (iii) provide that outstanding Awards shall become exercisable, realizable or deliverable, or restrictions applicable to an Award shall lapse, in whole or in part prior to or upon such Reorganization Event, (iv) in the event of a Reorganization Event under the terms of which holders of Common Stock will receive upon consummation thereof a cash payment for each share surrendered in the Reorganization Event (the “Acquisition Price”), make or provide for a cash payment to a Participant equal to the excess, if any, of (A) the Acquisition Price times the number of shares of Common Stock subject to the Participant’s Options or other Awards (to the extent the exercise price does not exceed the Acquisition Price) over (B) the aggregate exercise price of all such outstanding Options or other Awards and any applicable tax withholdings, in exchange for the termination of such Options or other Awards, (v) provide that, in connection with a liquidation or dissolution of the Company, Awards shall convert into the right to receive liquidation proceeds (if applicable, net of the exercise price thereof) and (vi) any combination of the foregoing.

 

For purposes of clause (i) above, an Option shall be considered assumed if, following consummation of the Reorganization Event, the Option confers the right to purchase, for each share of Common Stock subject to the Option immediately prior to the consummation of the Reorganization Event, the consideration (whether cash, securities or other property) received as a result of the Reorganization Event by holders of Common Stock for each share of Common Stock held immediately prior to the consummation of the Reorganization Event (and if holders were offered a choice of consideration, the type of consideration chosen by the holders of a majority of the outstanding shares of Common Stock); provided, however, that if the consideration received as a result of the Reorganization Event is not solely common stock of the acquiring or succeeding corporation (or an affiliate thereof), the Company may, with the consent

 

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of the acquiring or succeeding corporation, provide for the consideration to be received upon the exercise of Options to consist solely of common stock of the acquiring or succeeding corporation (or an affiliate thereof) equivalent in value (as determined by the Board) to the per share consideration received by holders of outstanding shares of Common Stock as a result of the Reorganization Event.

 

Consequences of a Reorganization Event on Restricted Stock Awards . Upon the occurrence of a Reorganization Event other than a liquidation or dissolution of the Company, the repurchase and other rights of the Company under each outstanding Restricted Stock Award shall inure to the benefit of the Company’s successor and shall apply to the cash, securities or other property which the Common Stock was converted into or exchanged for pursuant to such Reorganization Event in the same manner and to the same extent as they applied to the Common Stock subject to such Restricted Stock Award. Upon the occurrence of a Reorganization Event involving the liquidation or dissolution of the Company, except to the extent specifically provided to the contrary in the instrument evidencing any Restricted Stock Award or any other agreement between a Participant and the Company, all restrictions and conditions on all Restricted Stock Awards then outstanding shall automatically be deemed terminated or satisfied.

 

10. General Provisions Applicable to Awards

 

(a) Transferability of Awards . Except as the Board may otherwise determine or provide in an Award, Awards shall not be sold, assigned, transferred, pledged or otherwise encumbered by the person to whom they are granted, either voluntarily or by operation of law, except by will or the laws of descent and distribution or, other than in the case of an Incentive Stock Option, pursuant to a qualified domestic relations order, and, during the life of the Participant, shall be exercisable only by the Participant. References to a Participant, to the extent relevant in the context, shall include references to authorized transferees.

 

(b) Documentation . Each Award shall be evidenced in such form (written, electronic or otherwise) as the Board shall determine. Each Award may contain terms and conditions in addition to those set forth in the Plan.

 

(c) Board Discretion . Except as otherwise provided by the Plan, each Award may be made alone or in addition or in relation to any other Award. The terms of each Award need not be identical, and the Board need not treat Participants uniformly.

 

(d) Termination of Status . The Board shall determine the effect on an Award of the disability, death, termination of employment, authorized leave of absence or other change in the employment or other status of a Participant and the extent to which, and the period during which, the Participant, or the Participant’s legal representative, conservator, guardian or Designated Beneficiary, may exercise rights under the Award.

 

(e) Withholding . The Participant must satisfy all applicable federal, state, and local or other income and employment tax withholding obligations before the Company will deliver stock certificates or otherwise recognize ownership of Common Stock under an Award. The

 

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Company may decide to satisfy the withholding obligations through additional withholding on salary or wages. If the Company elects not to or cannot withhold from other compensation, the Participant must pay the Company the full amount, if any, required for withholding or have a broker tender to the Company cash equal to the withholding obligations. Payment of withholding obligations is due before the Company will issue any shares on exercise or release from forfeiture of an Award or, if the Company so requires, at the same time as is payment of the exercise price unless the Company determines otherwise. If provided for in an Award or approved by the Board in its sole discretion, a Participant may satisfy such tax obligations in whole or in part by delivery of shares of Common Stock, including shares retained from the Award creating the tax obligation, valued at their Fair Market Value; provided, however, except as otherwise provided by the Board, that the total tax withholding where stock is being used to satisfy such tax obligations cannot exceed the Company’s minimum statutory withholding obligations (based on minimum statutory withholding rates for federal and state tax purposes, including payroll taxes, that are applicable to such supplemental taxable income). Shares surrendered to satisfy tax withholding requirements cannot be subject to any repurchase, forfeiture, unfulfilled vesting or other similar requirements.

 

(f) Amendment of Award . The Board may amend, modify or terminate any outstanding Award, including but not limited to, substituting therefor another Award of the same or a different type, changing the date of exercise or realization, and converting an Incentive Stock Option to a Nonstatutory Stock Option, provided either (i) that the Participant’s consent to such action shall be required unless the Board determines that the action, taking into account any related action, would not materially and adversely affect the Participant or (ii) that the change is permitted under Section 9 hereof.

 

(g) Conditions on Delivery of Stock . The Company will not be obligated to deliver any shares of Common Stock pursuant to the Plan or to remove restrictions from shares previously delivered under the Plan until (i) all conditions of the Award have been met or removed to the satisfaction of the Company, (ii) in the opinion of the Company’s counsel, all other legal matters in connection with the issuance and delivery of such shares have been satisfied, including any applicable securities laws and any applicable stock exchange or stock market rules and regulations, and (iii) the Participant has executed and delivered to the Company such representations or agreements as the Company may consider appropriate to satisfy the requirements of any applicable laws, rules or regulations.

 

(h) Acceleration . The Board may at any time provide that any Award shall become immediately exercisable in full or in part, free of some or all restrictions or conditions, or otherwise realizable in full or in part, as the case may be.

 

(i) Performance Awards .

 

(1) Grants . Restricted Stock Awards and Other Stock Unit Awards under the Plan may be made subject to the achievement of performance goals pursuant to this Section 10(i) (“Performance Awards”), subject to the limit in Section 4(b) on shares covered by such grants.

 

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(2) Committee . Grants of Performance Awards to any Covered Employee intended to qualify as “performance-based compensation” under Section 162(m) (“Performance-Based Compensation”) shall be made only by a Committee (or subcommittee of a Committee) comprised solely of two or more directors eligible to serve on a committee making Awards qualifying as “performance-based compensation” under Section 162(m). In the case of such Awards granted to Covered Employees, references to the Board or to a Committee shall be deemed to be references to such Committee or subcommittee. “Covered Employee” shall mean any person who is a “covered employee” under Section 162(m)(3) of the Code.

 

(3) Performance Measures . For any Award that is intended to qualify as Performance-Based Compensation, the Committee shall specify that the degree of granting, vesting and/or payout shall be subject to the achievement of one or more objective performance measures established by the Committee, which shall be based on the relative or absolute attainment of specified levels of one or any combination of the following: (a) net income, (b) earnings before or after discontinued operations, interest, taxes, depreciation and/or amortization, (c) operating profit before or after discontinued operations and/or taxes, (d) sales, (e) sales growth, (f) earnings growth, (g) cash flow or cash position, (h) gross margins, (i) stock price, (j) market share, (k) return on sales, assets, equity or investment, (l) improvement of financial ratings, (m) achievement of balance sheet or income statement objectives or (n) total shareholder return, and may be absolute in their terms or measured against or in relationship to other companies comparably, similarly or otherwise situated. Such performance measures may be adjusted to exclude any one or more of (i) extraordinary items, (ii) gains or losses on the dispositions of discontinued operations, (iii) the cumulative effects of changes in accounting principles, (iv) the write-down of any asset, and (v) charges for restructuring and rationalization programs. Such performance measures: (i) may vary by Participant and may be different for different Awards; (ii) may be particular to a Participant or the department, branch, line of business, subsidiary or other unit in which the Participant works and may cover such period as may be specified by the Committee; and (iii) shall be set by the Committee within the time period prescribed by, and shall otherwise comply with the requirements of, Section 162(m). Awards that are not intended to qualify as Performance-Based Compensation may be based on these or such other performance measures as the Board may determine.

 

(4) Adjustments . Notwithstanding any provision of the Plan, with respect to any Performance Award that is intended to qualify as Performance-Based Compensation, the Committee may adjust downwards, but not upwards, the cash or number of Shares payable pursuant to such Award, and the Committee may not waive the achievement of the applicable performance measures except in the case of the death or disability of the Participant.

 

(5) Other . The Committee shall have the power to impose such other restrictions on Performance Awards as it may deem necessary or appropriate to ensure that such Awards satisfy all requirements for Performance-Based Compensation.

 

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11. Miscellaneous

 

(a) No Right To Employment or Other Status . No person shall have any claim or right to be granted an Award, and the grant of an Award shall not be construed as giving a Participant the right to continued employment or any other relationship with the Company. The Company expressly reserves the right at any time to dismiss or otherwise terminate its relationship with a Participant free from any liability or claim under the Plan, except as expressly provided in the applicable Award.

 

(b) No Rights As Stockholder . Subject to the provisions of the applicable Award, no Participant or Designated Beneficiary shall have any rights as a stockholder with respect to any shares of Common Stock to be distributed with respect to an Award until becoming the record holder of such shares. Notwithstanding the foregoing, in the event the Company effects a split of the Common Stock by means of a stock dividend and the exercise price of and the number of shares subject to such Option are adjusted as of the date of the distribution of the dividend (rather than as of the record date for such dividend), then an optionee who exercises an Option between the record date and the distribution date for such stock dividend shall be entitled to receive, on the distribution date, the stock dividend with respect to the shares of Common Stock acquired upon such Option exercise, notwithstanding the fact that such shares were not outstanding as of the close of business on the record date for such stock dividend.

 

(c) Effective Date and Term of Plan . The Plan shall become effective on the date on which it is adopted by the Board. No Awards shall be granted under the Plan after the completion of 10 years from the earlier of (i) the date on which the Plan was adopted by the Board or (ii) the date the Plan was approved by the Company’s stockholders, but Awards previously granted may extend beyond that date.

 

(d) Amendment of Plan . The Board may amend, suspend or terminate the Plan or any portion thereof at any time; provided that, to the extent determined by the Board, no amendment requiring stockholder approval under any applicable legal, regulatory or listing requirement shall become effective until such stockholder approval is obtained.

 

(e) Provisions for Foreign Participants . The Board may modify Awards or Options granted to Participants who are foreign nationals or employed outside the United States or establish subplans or procedures under the Plan to recognize differences in laws, rules, regulations or customs of such foreign jurisdictions with respect to tax, securities, currency, employee benefit or other matters.

 

(f) Compliance with Code Section 409A . No Award shall provide for deferral of compensation that does not comply with Section 409A of the Code, unless the Board, at the time of grant, specifically provides that the Award is not intended to comply with Section 409A of the Code. The Company shall have no liability to Participant, or to any other party, if an Award that is intended to be exempt from, or compliant with, Section 409A is not so exempt or compliant or for any action taken by the Board.

 

(g) Governing Law . The provisions of the Plan and all Awards made hereunder shall be governed by and interpreted in accordance with the laws of the State of Delaware, excluding choice-of-law principles of the law of such state that would require the application of the laws of a jurisdiction other than such state.

 

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ACHILLION PHARMACEUTICALS, INC.

 

Amendment No. 1 To

2006 Stock Incentive Plan

 

Achillion Pharmaceuticals, Inc.’s (the “Company”) 2006 Stock Incentive Plan (the “Plan”), pursuant to Section 11(d) thereof, is hereby amended as follows:

 

Section 9(a) of the Plan is deleted in its entirety and the following is inserted in lieu thereof:

 

“9. Adjustments for Changes in Common Stock and Certain Other Events .

 

  (a) Changes in Capitalization . In the event of any stock split, reverse stock split, stock dividend, recapitalization, combination of shares, reclassification of shares, spin-off or other similar change in capitalization or event, or any dividend or distribution to holders of Common Stock other than an ordinary cash dividend, (i) the number and class of securities available under this Plan, (ii) the sub-limits set forth in Section 4(b), (iii) the number and class of securities and exercise price per share of each outstanding Option, (iv) the share- and per-share provisions and the exercise price of each Stock Appreciation Right, (v) the number of shares subject to and the repurchase price per share subject to each outstanding Restricted Stock Award and (vi) the share- and per-share-related provisions and the purchase price, if any, of each outstanding Other Stock Unit Award, shall be appropriately and equitably adjusted by the Company (or substituted Awards may be made, if applicable) in the manner determined by the Board.”

 

Adopted by the Board of Directors: September 18, 2006

Exhibit 10.24

 

ACHILLION PHARMACEUTICALS, INC.

 

2006 EMPLOYEE STOCK PURCHASE PLAN

 

The purpose of this Plan is to provide eligible employees of Achillion Pharmaceuticals, Inc. (the “Company”) and certain of its subsidiaries with opportunities to purchase shares of the Company’s common stock, $.001 par value (the “Common Stock”). 2,000,000 shares of Common Stock in the aggregate have been approved for this purpose. This Plan is intended to qualify as an “employee stock purchase plan” as defined in Section 423 of the Internal Revenue Code of 1986, as amended (the “Code”), and the regulations promulgated thereunder, and shall be interpreted consistent therewith.

 

1. Administration . The Plan will be administered by the Company’s Board of Directors (the “Board”) or by a Committee appointed by the Board (the “Committee”). The Board or the Committee has authority to make rules and regulations for the administration of the Plan and its interpretation and decisions with regard thereto shall be final and conclusive.

 

2. Eligibility . All employees of the Company, including Directors who are employees, and all employees of any subsidiary of the Company (as defined in Section 424(f) of the Code) designated by the Board or the Committee from time to time (a “Designated Subsidiary”), are eligible to participate in any one or more of the offerings of Options (as defined in Section 9) to purchase Common Stock under the Plan provided that:

 

(a) they are customarily employed by the Company or a Designated Subsidiary for more than 20 hours a week and for more than five months in a calendar year; and

 

(b) they have been employed by the Company or a Designated Subsidiary for at least six months prior to enrolling in the Plan; and

 

(c) they are employees of the Company or a Designated Subsidiary on the first day of the applicable Plan Period (as defined below).

 

No employee may be granted an option hereunder if such employee, immediately after the option is granted, owns 5% or more of the total combined voting power or value of the stock of the Company or any subsidiary. For purposes of the preceding sentence, the attribution rules of Section 424(d) of the Code shall apply in determining the stock ownership of an employee, and all stock which the employee has a contractual right to purchase shall be treated as stock owned by the employee.

 

3. Offerings . The Company will make one or more offerings (“Offerings”) to employees to purchase stock under this Plan. Offerings will begin each September 1 and March 1, or the first business day thereafter (the “Offering Commencement Dates”). Each Offering Commencement Date will begin a six-month period (a “Plan Period”) during which payroll deductions will be made and held for the purchase of Common Stock at the end of the Plan Period. The Board or the Committee may, at its discretion, choose a different Plan Period of twelve (12) months or less for subsequent Offerings. Notwithstanding anything to the contrary, the first Plan Period shall begin on the later of (i) the first date that the Common Stock is

 

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publicly traded following the Company’s initial public offering (the “IPO Date”) or (ii) September 1, 2006, and shall end on February 28, 2007.

 

4. Participation . An employee eligible on the Offering Commencement Date of any Offering may participate in such Offering by completing and forwarding a payroll deduction authorization form to the employee’s appropriate payroll office at least five business days prior to the applicable Offering Commencement Date. The form will authorize a regular payroll deduction from the Compensation received by the employee during the Plan Period. Unless an employee files a new form or withdraws from the Plan, his deductions and purchases will continue at the same rate for future Offerings under the Plan as long as the Plan remains in effect. The term “Compensation” means the amount of money reportable on the employee’s Federal Income Tax Withholding Statement, excluding overtime, shift premium, incentive or bonus awards, allowances and reimbursements for expenses such as relocation allowances for travel expenses, income or gains associated with the grant or vesting of restricted stock, income or gains on the exercise of Company stock options or stock appreciation rights, and similar items, whether or not shown on the employee’s Federal Income Tax Withholding Statement, but including, in the case of salespersons, sales commissions to the extent determined by the Board or the Committee.

 

5. Deductions . The Company will maintain payroll deduction accounts for all participating employees. With respect to any Offering made under this Plan, an employee may authorize a payroll deduction in any dollar amount up to a maximum of 15% of the Compensation he or she receives during the Plan Period or such shorter period during which deductions from payroll are made. The Board or the Committee may, at its discretion, designate a lower maximum contribution rate. Payroll deductions may be at the rate of 2%, 4%, 6%, 8% or 10% of Compensation with any change in compensation during the Plan Period to result in an automatic corresponding change in the dollar amount withheld. The minimum payroll deduction is such percentage of compensation as may be established from time to time by the Board or the Committee.

 

6. Deduction Changes . An employee may decrease or discontinue his payroll deduction once during any Plan Period, by filing a new payroll deduction authorization form. However, an employee may not increase his payroll deduction during a Plan Period. If an employee elects to discontinue his payroll deductions during a Plan Period, but does not elect to withdraw his funds pursuant to Section 8 hereof, funds deducted prior to his election to discontinue will be applied to the purchase of Common Stock on the Exercise Date (as defined below).

 

7. Interest . Interest will not be paid on any employee accounts, except to the extent that the Board or the Committee, in its sole discretion, elects to credit employee accounts with interest at such per annum rate as it may from time to time determine.

 

8. Withdrawal of Funds . An employee may at any time prior to the close of business on the last business day in a Plan Period and for any reason permanently draw out the balance accumulated in the employee’s account and thereby withdraw from participation in an Offering. Partial withdrawals are not permitted. The employee may not begin participation again during

 

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the remainder of the Plan Period. The employee may participate in any subsequent Offering in accordance with terms and conditions established by the Board or the Committee.

 

9. Purchase of Shares .

 

(a) Number of Shares . On the Offering Commencement Date of each Plan Period, the Company will grant to each eligible employee who is then a participant in the Plan an option (an “Option”) to purchase on the last business day of such Plan Period (the “Exercise Date”) at the applicable purchase price (the “Option Price”) the largest number of whole shares of Common Stock of the Company as does not exceed the employee’s accumulated payroll deductions as of the Exercise Date divided by the Option Price for such Plan Period; provided, however, that no employee may be granted an Option which permits his rights to purchase Common Stock under this Plan and any other employee stock purchase plan (as defined in Section 423(b) of the Code) of the Company and its subsidiaries, to accrue at a rate which exceeds $25,000 of the fair market value of such Common Stock for each calendar year in which the Option is outstanding at any time.

 

(b) Option Price . The Board or the Committee shall determine the Option Price for each Plan Period, including whether such Option Price shall be determined based on the lesser of (i) the closing price of the Common Stock on the first business day of the Plan Period or (ii) the Exercise Date, or shall be based solely on the closing price of the Common Stock on the Exercise Date; provided, however, that such Option Price shall be at least 85% of the applicable closing price. In the absence of a determination by the Board or the Committee, the Option Price will be 85% of the lesser of the closing price of the Common Stock on the (i) first business day of the Plan Period or (ii) the Exercise Date. The closing price shall be (a) the closing price on any national securities exchange on which the Common Stock is listed, (b) the closing price of the Common Stock on the Nasdaq National Market or (c) the average of the closing bid and asked prices in the over-the-counter-market, whichever is applicable, as published in The Wall Street Journal ; provided that, with respect to the first Plan Period, the closing price on the Offering Commencement Date shall be the initial public offering price provided for in the underwriting agreement entered into by the Company in connection with the IPO. If no sales of Common Stock were made on such a day, the price of the Common Stock for purposes of clauses (a) and (b) above shall be the reported price for the next preceding day on which sales were made.

 

(c) Exercise of Option . Each employee who continues to be a participant in the Plan on the Exercise Date shall be deemed to have exercised his Option at the Option Price on such date and shall be deemed to have purchased from the Company the number of whole shares of Common Stock reserved for the purpose of the Plan that his accumulated payroll deductions on such date will pay for, but not in excess of the maximum number determined in the manner set forth above.

 

(d) Return of Unused Payroll Deductions . Any balance remaining in an employee’s payroll deduction account at the end of a Plan Period will be automatically refunded to the employee, except that any balance which is less than the purchase price of one share of Common Stock will be carried forward into the employee’s payroll deduction account for the

 

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following Offering, unless the employee elects not to participate in the following Offering under the Plan, in which case the balance in the employee’s account shall be refunded.

 

10. Issuance of Certificates . Certificates representing shares of Common Stock purchased under the Plan may be issued only in the name of the employee, in the name of the employee and another person of legal age as joint tenants with rights of survivorship, or (in the Company’s sole discretion) in the name of a brokerage firm, bank, or other nominee holder designated by the employee. The Company may, in its sole discretion and in compliance with applicable laws, authorize the use of book entry registration of shares in lieu of issuing stock certificates.

 

11. Rights on Retirement, Death or Termination of Employment . In the event of a participating employee’s termination of employment prior to the last business day of a Plan Period, no payroll deduction shall be taken from any pay due and owing to an employee and the balance in the employee’s account shall be paid to the employee or, in the event of the employee’s death, (a) to a beneficiary previously designated in a revocable notice signed by the employee (with any spousal consent required under state law) or (b) in the absence of such a designated beneficiary, to the executor or administrator of the employee’s estate or (c) if no such executor or administrator has been appointed to the knowledge of the Company, to such other person(s) as the Company may, in its discretion, designate. If, prior to the last business day of the Plan Period, the Designated Subsidiary by which an employee is employed shall cease to be a subsidiary of the Company, or if the employee is transferred to a subsidiary of the Company that is not a Designated Subsidiary, the employee shall be deemed to have terminated employment for the purposes of this Plan.

 

12. Optionees Not Stockholders . Neither the granting of an Option to an employee nor the deductions from his pay shall constitute such employee a stockholder of the shares of Common Stock covered by an Option under this Plan until such shares have been purchased by and issued to him.

 

13. Rights Not Transferable . Rights under this Plan are not transferable by a participating employee other than by will or the laws of descent and distribution, and are exercisable during the employee’s lifetime only by the employee.

 

14. Application of Funds . All funds received or held by the Company under this Plan may be combined with other corporate funds and may be used for any corporate purpose.

 

15. Adjustment for Changes in Common Stock and Certain Other Events .

 

a) Changes in Capitalization . In the event of any stock split, reverse stock split, stock dividend, recapitalization, combination of shares, reclassification of shares, spin-off or other similar change in capitalization or event, or any distribution to holders of Common Stock other than an ordinary cash dividend, (i) the number and class of securities available under this Plan, (ii) the share limitations set forth in Section 9, and (iii) the Option Price shall be appropriately adjusted to the extent determined by the Board or the Committee.

 

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(b) Reorganization Events .

 

(1) Definition . A “Reorganization Event” shall mean: (a) any merger or consolidation of the Company with or into another entity as a result of which all of the Common Stock of the Company is converted into or exchanged for the right to receive cash, securities or other property or is cancelled, (b) any exchange of all of the Common Stock of the Company for cash, securities or other property pursuant to a share exchange transaction or (c) any liquidation or dissolution of the Company.

 

(2) Consequences of a Reorganization Event on Options . In connection with a Reorganization Event, the Board or the Committee shall take any one or more of the following actions as to outstanding Options on such terms as the Board or the Committee determines: (i) provide that Options shall be assumed, or substantially equivalent Options shall be substituted, by the acquiring or succeeding corporation (or an affiliate thereof), (ii) upon written notice to employees, provide that all outstanding Options will be terminated as of the effective date of the Reorganization Event and that all such outstanding Options will become exercisable to the extent of accumulated payroll deductions as of a date specified by the Board or the Committee in such notice, which date shall not be less than ten (10) days preceding the effective date of the Reorganization Event, (iii) upon written notice to employees, provide that all outstanding Options will be cancelled as of a date prior to the effective date of the Reorganization Event and that all accumulated payroll deductions will be returned to participating employees on such date, (iv) in the event of a Reorganization Event under the terms of which holders of Common Stock will receive upon consummation thereof a cash payment for each share surrendered in the Reorganization Event (the “Acquisition Price”), make or provide for a cash payment to an employee equal to (A) the Acquisition Price times the number of shares of Common Stock subject to the employee’s Option (to the extent the Option Price does not exceed the Acquisition Price) minus (B) the aggregate Option Price of such Option, in exchange for the termination of such Option, (v) provide that, in connection with a liquidation or dissolution of the Company, Options shall convert into the right to receive liquidation proceeds (net of the Option Price thereof) and (vi) any combination of the foregoing.

 

For purposes of clause (i) above, an Option shall be considered assumed if, following consummation of the Reorganization Event, the Option confers the right to purchase, for each share of Common Stock subject to the Option immediately prior to the consummation of the Reorganization Event, the consideration (whether cash, securities or other property) received as a result of the Reorganization Event by holders of Common Stock for each share of Common Stock held immediately prior to the consummation of the Reorganization Event (and if holders were offered a choice of consideration, the type of consideration chosen by the holders of a majority of the outstanding shares of Common Stock); provided, however, that if the consideration received as a result of the Reorganization Event is not solely common stock of the acquiring or succeeding corporation (or an affiliate thereof), the Company may, with the consent of the acquiring or succeeding corporation, provide for the consideration to be received upon the exercise of Options to consist solely of common stock of the acquiring or succeeding corporation (or an affiliate thereof) equivalent in value (as determined by the Board) to the per share consideration received by holders of outstanding shares of Common Stock as a result of the Reorganization Event.

 

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16. Amendment of the Plan . The Board may at any time, and from time to time, amend this Plan in any respect, except that (a) if the approval of any such amendment by the shareholders of the Company is required by Section 423 of the Code, such amendment shall not be effected without such approval, and (b) in no event may any amendment be made which would cause the Plan to fail to comply with Section 423 of the Code.

 

17. Insufficient Shares . In the event that the total number of shares of Common Stock specified in elections to be purchased under any Offering plus the number of shares purchased under previous Offerings under this Plan exceeds the maximum number of shares issuable under this Plan, the Board or the Committee will allot the shares then available on a pro-rata basis.

 

18. Termination of the Plan . This Plan may be terminated at any time by the Board. Upon termination of this Plan all amounts in the accounts of participating employees shall be promptly refunded.

 

19. Governmental Regulations . The Company’s obligation to sell and deliver Common Stock under this Plan is subject to listing on a national stock exchange or quotation on the Nasdaq National Market (to the extent the Common Stock is then so listed or quoted) and the approval of all governmental authorities required in connection with the authorization, issuance or sale of such stock.

 

20. Governing Law . The Plan shall be governed by Delaware law except to the extent that such law is preempted by federal law.

 

21. Issuance of Shares . Shares may be issued upon exercise of an Option from authorized but unissued Common Stock, from shares held in the treasury of the Company, or from any other proper source.

 

22. Notification upon Sale of Shares . Each employee agrees, by entering the Plan, to promptly give the Company notice of any disposition of shares purchased under the Plan where such disposition occurs within two years after the date of grant of the Option pursuant to which such shares were purchased.

 

23. Special Provisions for First Plan Period . The following provisions of this Section 23 shall apply with respect to the first Plan Period notwithstanding any provision of the Plan to the contrary:

 

Every eligible employee shall automatically become a participant in the Plan for the first Plan Period at the highest percentage of Compensation permitted under Section 5. No payroll deductions shall be required for the first Plan Period; however, a participant may, at any time after the effectiveness of the Plan’s Registration Statement on Form S-8, elect to have payroll deductions up to the aggregate amount which would have been credited to his or her account if a deduction of ten percent (10%) of the Compensation which he or she received on each pay day during the first Plan Period had been made (the “Maximum Amount”) or decline to participate by filing an appropriate subscription agreement.

 

Upon the automatic exercise of a participant’s option on the Exercise Date for the first Plan Period, a participant shall be permitted to purchase shares with (i) the accumulated payroll

 

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deductions in his or her account, if any, (ii) a direct payment from the participant, or (iii) a combination thereof; provided, however that the total amount applied to the purchase may not exceed the Maximum Amount.

 

24. Withholding . Each employee shall, no later than the date of the event creating the tax liability, make provision satisfactory to the Board for payment of any taxes required by law to be withheld in connection with any transaction related to Options granted to or shares acquired by such employee pursuant to the Plan. The Company may, to the extent permitted by law, deduct any such taxes from any payment of any kind otherwise due to an employee.

 

25. Effective Date and Approval of Shareholders . The Plan shall take effect on the IPO Date, subject to approval by the shareholders of the Company as required by Section 423 of the Code, which approval must occur within twelve months of the adoption of the Plan by the Board.

 

Adopted by the Board of Directors

on May 15, 2006

Approved by the stockholders on

September 21, 2006

 

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ACHILLION PHARMACEUTICALS, INC.

 

Amendment No. 1 To

2006 Employee Stock Purchase Plan

 

Achillion Pharmaceuticals, Inc.’s (the “Company”) Employee Stock Purchase Plan (the “Plan”), pursuant to Section 16 thereof, is hereby amended as follows:

 

Section 3 of the Plan is deleted in its entirety and the following is inserted in lieu thereof:

 

“3. Offerings . The Company will make one or more offerings (“Offerings”) to employees to purchase stock under this Plan. Offerings will begin each December 1 and June 1, or the first business day thereafter (the “Offering Commencement Dates”). Each Offering Commencement Date will begin a six-month period (a “Plan Period”) during which payroll deductions will be made and held for the purchase of Common Stock at the end of the Plan Period. The Board or the Committee may, at its discretion, choose a different Plan Period of twelve (12) months or less for subsequent Offerings. Notwithstanding anything to the contrary, the first Plan Period shall begin on the later of (i) the first date that the Common Stock is publicly traded following the Company’s initial public offering (the “IPO Date”) or (ii) December 1, 2006, and shall end on May 31, 2007.”

 

Section 15(a) of the Plan is deleted in its entirety and the following is inserted in lieu thereof:

 

“15. Adjustment for Changes in Common Stock and Certain Other Events .

 

(a) Changes in Capitalization . In the event of any stock split, reverse stock split, stock dividend, recapitalization, combination of shares, reclassification of shares, spin-off or other similar change in capitalization or event, or any distribution to holders of Common Stock other than an ordinary cash dividend, (i) the number and class of securities available under this Plan, (ii) the share limitations set forth in Section 9, and (iii) the Option Price shall be appropriately and equitably adjusted in the manner determined by the Board or the Committee.”

 

Adopted by the Board of Directors: September 18, 2006

Exhibit 10.29

THESE SECURITIES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR ANY STATE SECURITIES LAWS. THEY MAY NOT BE SOLD OR OFFERED FOR SALE IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT AS TO THE SECURITIES UNDER SAID ACT AND ANY APPLICABLE STATE SECURITIES LAWS OR THE AVAILABILITY OF AN EXEMPTION FROM REGISTRATION UNDER SAID ACT AND ANY APPLICABLE STATE SECURITIES LAWS.

STOCK SUBSCRIPTION WARRANT

To Purchase 233,000 Shares of Common Stock of

ACHILLION PHARMACEUTICALS, INC (the “Company”)

DATE OF INITIAL ISSUANCE: November 7, 2000

THIS CERTIFIES THAT for value received, CONNECTICUT INNOVATIONS, INCORPORATED or its registered assigns (the “Holder” ) is entitled to purchase from the Company, at any time during the Term of this Warrant, Two Hundred Thirty Three Thousand (233,000) shares of common stock, $.001 par value, of the Company (the “Common Stock” ), at the Warrant Price, payable in lawful money of the United States of America to be paid upon the exercise hereof. The exercise of this Warrant shall be subject to the provisions, limitations and, restrictions herein contained, and may be exercised in whole or in part.

SECTION 1. Definitions .

For all purposes of this Warrant, the following terms shall have the meanings indicated:

Common Stock - shall mean and include the Company’s authorized Common Stock, $.001 par value, as constituted at the date hereof.

Current Market Price - shall mean, at any date and with respect to one share of Common Stock, the average of the daily closing prices for the 30 consecutive business days ending five business days before the day in question (as adjusted for any stock dividend, split, combination or reclassification that took effect during such 30 business day period). The closing price for each day shall be the last reported sales price or, in case no such reported sales took place on such day, the average of the last reported bid and asked prices, in either case on the principal national securities exchange on which the Common Stock is listed or admitted to trading or as reported by Nasdaq (or if the Common Stock is not at the time listed or admitted for trading on any such exchange or if prices of the Common Stock are not reported by Nasdaq then such price shall be equal to the average of the last reported bid and asked prices on such day as reported by The National Quotation Bureau Incorporated or any similar reputable quotation and reporting service, if such quotation is not reported by The National Quotation Bureau Incorporated); provided, however, that if the Common Stock is not traded in such manner that the quotations referred to herein are available for the period required hereunder, the Current Market Price shall be determined in good faith by the


Board of Directors of the Company or, if such determination cannot be made, by a nationally recognized independent investment banking firm selected by the Board of Directors of the Company (or if such selection cannot be made, by a nationally recognized independent investment banking firm selected by the American Arbitration Association in accordance with its rules).

Exchange Act - shall mean the Securities Exchange Act of 1934, as amended from time to time.

Securities Act - shall mean the Securities Act of 1933, as amended.

Term of this Warrant - shall mean the period beginning on the date of initial issuance hereof and ending on October 4, 2010.

Warrant Price - shall mean $1.50 per share, subject to adjustment in accordance with Section 5 hereof.

Warrant Shares - shall mean shares of Common Stock purchased or purchasable by the Holder of this Warrant upon the exercise hereof.

SECTION 2. Exercise of Warrant .

2.1. Procedure for Exercise of Warrant . To exercise this Warrant in whole or in part (but not as to any fractional share of Common Stock), the Holder shall deliver to the Company at its office referred to in Section 14 hereof at any time and from time to time during the Term of this Warrant: (i) the Notice of Exercise in the form attached hereto, (ii) cash, certified or official bank check payable to the order of the Company, wire transfer of funds to the Company’s account, or evidence of any indebtedness of the Company to the Holder (or any combination of any of the foregoing) in the amount of the Warrant Price for each share being purchased, and (iii) this Warrant. Notwithstanding any provisions herein to the contrary, if the Current Market Price is greater than the Warrant Price (at the date of calculation, as set forth below), in lieu of exercising this Warrant as hereinabove permitted, the Holder may elect to receive shares of Common Stock equal to the value (as determined below) of this Warrant (or the portion thereof being canceled) by surrender of this Warrant at the office of the Company referred to in Section 14 hereof, together with the Notice of Exercise, in which event the Company shall issue to the Holder that number of shares of Common Stock computed using the following formula:

 

CS

  WCS x (CMP-WP)
                CMP

 

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where:

CS equals the number of shares of Common Stock to be issued to the Holder;

WCS equals the number of shares of Common Stock purchasable under the Warrant or, if only a portion of the Warrant is being exercised, the portion of the Warrant being exercised (at the date of such calculation);

CMP equals the Current Market Price (at the date of such calculation); and

WP equals the Warrant Price (as adjusted to the date of such calculation).

In the event of any exercise of the rights represented by this Warrant, a certificate or certificates for the shares of Common Stock so purchased, registered in the name of the Holder or such other name or names as may be designated by the Holder, shall be delivered to the Holder hereof within a reasonable time, not exceeding fifteen days, after the rights represented by this Warrant shall have been so exercised; and, unless this Warrant has expired, a new Warrant representing the number of shares (except a remaining fractional share), if any, with respect to which this Warrant shall not then have been exercised shall also be issued to the Holder hereof within such time. The person in whose name any certificate for shares of Common Stock is issued upon exercise of this Warrant shall for all purposes be deemed to have become the holder of record of such shares on the date on which the Warrant was surrendered and payment of the Warrant Price and any applicable taxes was made, irrespective of the date of delivery of such certificate, except that, if the date of such surrender and payment is a date when the stock transfer books of the Company are closed, such person shall be deemed to have become the holder of such shares at the close of business on the next succeeding date on which the stock transfer books are open.

2.2. Transfer Restriction Legend . Each certificate for Warrant Shares shall bear the following legend (and any additional legend required by (i) any applicable state securities laws and (ii) any securities exchange upon which such Warrant Shares may, at the time of such exercise, be listed) on the face thereof unless at the time of exercise such Warrant Shares shall be registered under the Securities Act:

THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE BEEN ACQUIRED FOR INVESTMENT AND HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933. THESE SECURITIES MAY NOT BE SOLD OR TRANSFERRED IN THE ABSENCE OF SUCH REGISTRATION OR AN EXEMPTION THEREFROM UNDER SAID ACT.

Any certificate issued at any time in exchange or substitution for any certificate bearing such legend (except a new certificate issued upon completion of a public distribution under a registration statement of the securities represented thereby) shall also bear such legend unless, in the opinion of counsel for the holder thereof (which counsel shall be reasonably satisfactory to counsel for the Company) the securities represented thereby are not, at such time, required by law to bear such legend.

 

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SECTION 3. Covenants as to Common Stock . The Company covenants and agrees that all shares of Common Stock that may be issued upon the exercise of the rights represented by this Warrant will, upon issuance, be validly issued, fully paid and nonassessable, and free from all taxes (other than income taxes that may be payable by the Holder), liens and charges with respect to the issue thereof. Without limiting the generality of the foregoing, the Company covenants that it will from time to time take all such action as may be requisite to assure that the stated or par value per share, if any, of the Common Stock is at all times equal to or less than the then Warrant Price. The Company further covenants and agrees that it will pay when due and payable any and all federal and state taxes which may be payable in respect of the issue of this Warrant or any Common Stock or certificates therefor issuable upon the exercise of this Warrant. The Company further covenants and agrees that the Company will at all times have authorized and reserved, free from preemptive rights, a sufficient number of shares of Common Stock to provide for the exercise of the rights represented by this Warrant. The Company further covenants and agrees that if any shares of capital stock to be reserved for the purpose of the issuance of shares upon the exercise of this Warrant require registration with or approval of any governmental authority under any federal or state law before such shares may be validly issued or delivered upon exercise, then the Company will in good faith and as expeditiously as possible endeavor to secure such registration or approval, as the case may be. If and so long as the Common Stock issuable upon the exercise of this Warrant is listed on any national securities exchange, the Company will, if permitted by the rules of such exchange, list and keep listed on such exchange, upon official notice of issuance, all shares of such Common Stock issuable upon exercise of this Warrant. The Company shall take no action which would cause any changes in the Common Stock as to which an appropriate adjustment in the number of Warrant Shares and Warrant Price could not be readily made pursuant to the intent of Sections 4 and 5 hereof.

SECTION 4. Adjustment of Number of Shares . Upon each adjustment of the Warrant Price as provided in Section 5, the Holder shall thereafter be entitled to purchase, at the Warrant Price resulting from such adjustment, the number of shares (calculated to the nearest tenth of a share) obtained by multiplying the Warrant Price in effect immediately prior to such adjustment by the number of shares purchasable pursuant hereto immediately prior to such adjustment and dividing the product thereof by the Warrant Price resulting from such adjustment.

SECTION 5. Adjustment of Warrant Price . The Warrant Price shall be subject to adjustment from time to time as follows:

(i) Economic Diluting Issuances .

(i) If the Company shall at any time or from time to time during the Term of this Warrant issue shares of Common Stock other than Excluded Stock (as hereinafter defined) without consideration or for a consideration per share less than the Warrant Price in effect immediately prior to the issuance of such Common Stock, the Warrant Price in effect immediately prior to each such issuance or adjustment shall forthwith be adjusted to a price equal to the quotient obtained by dividing:

 

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(A) an amount equal to the sum of

(x) the total number of shares of Common Stock outstanding (including any shares of Common Stock deemed to have been issued pursuant to subdivision (3) of this clause (i) and to clause (ii) below) immediately prior to such issuance multiplied by the Warrant Price in effect immediately prior to such issuance, plus

(y) the consideration received by the Company upon such issuance,

by

(B) the total number of shares of Common Stock outstanding (including any shares of Common Stock deemed to have been issued pursuant to subdivision (3) of this clause (i) and to clause (ii) below) immediately after the issuance of such Common Stock.

For the purposes of any adjustment of the Warrant Price pursuant to this clause (i), the following provisions shall be applicable:

1. In the case of the issuance of Common Stock for cash, the consideration shall be deemed to be the amount of cash paid therefor prior to deducting therefrom any discounts, commissions or other expenses allowed, paid or incurred by the Company for any underwriting or otherwise in connection with the issuance and sale thereof.

2. In the case of the issuance of Common Stock for a consideration in whole or in part other than cash, the consideration other than cash shall be deemed to be the fair market value thereof as determined by the Board of Directors of the Company, irrespective of any accounting treatment.

3. In the case of the issuance of (i) options to purchase or rights to subscribe for Common Stock, (ii) securities by their terms convertible into or exchangeable for Common Stock or (iii) options to purchase or rights to subscribe for such convertible or exchangeable securities:

(A) the aggregate maximum number of shares of Common Stock deliverable upon exercise of such options to purchase or rights to subscribe for Common Stock shall be deemed to have been issued at the time such options or rights were issued and for a consideration equal to the consideration (determined in the manner provided in subdivisions (1) and (2) above), if any, received by the Company upon the issuance of such options or rights plus the minimum purchase price provided in such options or rights for the Common Stock covered thereby;

 

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(B) the aggregate maximum number of shares of Common Stock deliverable upon conversion of or in exchange for any such convertible or exchangeable securities or upon the exercise of options to purchase or rights to subscribe for such convertible or exchangeable securities and subsequent conversions or exchanges thereof shall be deemed to have been issued at the time such securities were issued or such options or rights were issued and for a consideration equal to the consideration received by the Company for any such securities and related options or rights (excluding any cash received on account of accrued interest or accrued dividends), plus the additional consideration, if any, to be received by the Company upon the conversion or exchange of such securities or the exercise of any related options or rights (the consideration in each case to be determined in the manner provided in subdivisions (1) and (2) above);

(C) on any change in the number of shares of Common Stock deliverable upon exercise of any such options or rights or conversion of or exchange for such convertible or exchangeable securities, other than a change resulting from the antidilution provisions thereof, the Warrant Price shall forthwith be readjusted to such Warrant Price as would have obtained had the adjustment made upon the issuance of such options, rights or securities not converted prior to such change or options or rights related to such securities not converted prior to such change being made upon the basis of such change; and

(D) on the expiration of any such options or rights, the termination of any such rights to convert or exchange or the expiration of any options or rights related to such convertible or exchangeable securities, the Warrant Price shall forthwith be readjusted to such Warrant Price as would have obtained had the adjustment made upon the issuance of such options, rights, securities or options or rights related to such securities being made upon the basis of the issuance of only the number of shares of Common Stock actually issued upon the conversion or exchange of such securities or upon the exercise of the options or rights related to such securities.

(ii) “Excluded Stock” shall mean shares of Common Stock described in Section D.5.E. of Article IV of the Amended and Restated Certificate of Incorporation of the Company dated as of January 28, 2000, as such Section D.5.E. may hereafter be amended.

(iii) Stock Dividends, Subdivisions, Split-Ups . If, at any time during the Term of this Warrant, the number of shares of Common Stock outstanding is increased by a stock dividend payable in shares of Common Stock or by a subdivision or split-up of shares of Common Stock, then, following the record date fixed for the determination of holders of Common Stock entitled to receive such stock dividend, subdivision or split-up, the Warrant Price shall be appropriately decreased so that the number of shares of Common Stock issuable upon the exercise hereof shall be increased in proportion to such increase in outstanding shares.

 

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(iv) Stock Combinations . If, at any time during the Term of this Warrant, the number of shares of Common Stock outstanding is decreased by a combination of the outstanding shares of Common Stock, then, following the record date for such combination, the Warrant Price shall appropriately increase so that the number of shares of Common Stock issuable upon the exercise hereof shall be decreased in proportion to such decrease in outstanding shares.

(v) Certain Dividends . If, at any time during the Term of this Warrant, the Company shall declare a cash dividend upon its Common Stock payable otherwise than out of earnings or earned surplus or shall distribute to holders of its Common Stock shares of its capital stock (other than Common Stock), stock or other securities of other persons, evidences of indebtedness issued by the Company or other persons, assets (excluding cash dividends and distributions) or options or rights (excluding options to purchase and rights to subscribe for Common Stock or other securities of the Company convertible into or exchangeable for Common Stock), then, in each such case, immediately following the record date fixed for the determination of the holders of Common Stock entitled to receive such dividend or distribution, the Warrant Price in effect thereafter shall be determined by multiplying the Warrant Price in effect immediately prior to such record date by a fraction of which the numerator shall be an amount equal to the difference of (x) the Current Market Price of one share of Common Stock minus (y) the fair market value (as determined by the Board of Directors of the Company, whose determination shall be conclusive) of the stock, securities, evidences of indebtedness, assets, options or rights so distributed in respect of one share of Common Stock, and of which the denominator shall be such Current Market Price.

(vi) All calculations under this Section 5 shall be made to the nearest cent or to the nearest one-tenth (1/10) of a share, as the case may be.

(vii) Whenever the Warrant Price shall be adjusted as provided in Section 5, the Company shall prepare a statement showing the facts requiring such adjustment and the Warrant Price that shall be in effect after such adjustment. The Company shall cause a copy of such statement to be sent by mail, first class postage prepaid, to each Holder of this Warrant at its, his or her address appearing on the Company’s records. Where appropriate, such copy may be given in advance and may be included as part of the notice required to be mailed under the provisions of subsection (ix) of this Section 5.

(viii) Adjustments made pursuant to clauses (iii), (iv) and (v) above shall be made on the date such dividend, subdivision, split-up, combination or distribution, as the case may be, is made, and shall become effective at the opening of business on the business day next following the record date for the determination of stockholders entitled to such dividend, subdivision, split-up, combination or distribution.

(ix) In the event the Company shall propose to take any action of the types described in clauses (iii), (iv) or (v) of this Section 5, the Company shall forward, at the same time and in the same manner, to the Holder of this Warrant such notice, if any, which the Company shall give to the holders of capital stock of the Company.

 

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(x) In any case in which the provisions of this Section 5 shall require that an adjustment shall become effective immediately after a record date for an event, the Company may defer until the occurrence of such event issuing to the Holder of all or any part of this Warrant which is exercised after such record date and before the occurrence of such event the additional shares of capital stock issuable upon such exercise by reason of the adjustment required by such event over and above the shares of capital stock issuable upon such exercise before giving effect to such adjustment exercise; provided, however, that the Company shall deliver to such Holder a due bill or other appropriate instrument evidencing such Holder’s right to receive such additional shares upon the occurrence of the event requiring such adjustment.

(xi) The sale or other disposition of any Common Stock theretofore held in the treasury of the Company shall be deemed to be an issuance thereof.

SECTION 6. Ownership .

6.1. Ownership of This Warrant . The Company may deem and treat the person in whose name this Warrant is registered as the holder and owner hereof (notwithstanding any notations of ownership or writing hereon made by anyone other than the Company) for all purposes and shall not be affected by any notice to the contrary until presentation of this Warrant for registration of transfer as provided in this Section 6.

6.2. Transfer and Replacement . Subject to the restrictions on transferability set forth in the Amended and Restated Stockholders’ Agreement dated as of February 3, 2000 among the Company, the Holder and certain other parties, this Warrant and all rights hereunder are transferable in whole or in part upon the books of the Company by the Holder hereof in person or by its duly authorized attorney, and a new Warrant or Warrants, of the same tenor as this Warrant but registered in the name of the transferee or transferees (and in the name of the Holder, if a partial transfer is effected) shall be made and delivered by the Company upon surrender of this Warrant duly endorsed, at the office of the Company referred to in Section 14 hereof. Upon receipt by the Company of evidence reasonably satisfactory to it of the loss, theft or destruction, and, in such case, of indemnity or security reasonably satisfactory to it, and upon surrender of this Warrant if mutilated, the Company will make and deliver a new Warrant of like tenor, in lieu of this Warrant; provided that if the Holder hereof is an instrumentality of a state or local government or an institutional holder or a nominee for such an instrumentality or institutional holder an irrevocable agreement of indemnity by such Holder shall be sufficient for all purposes of this Section 6, and no evidence of loss or theft or destruction shall be necessary. This Warrant shall be promptly cancelled by the Company upon the surrender hereof in connection with any transfer or replacement. Except as otherwise provided above, in the case of the loss, theft or destruction of a Warrant, the Company shall pay all expenses, taxes and other charges payable in connection with any transfer or replacement of this Warrant, other than stock transfer taxes (if any) payable in connection with a transfer of this Warrant, which shall be payable by the Holder. Holder will not transfer this Warrant and the rights hereunder except in compliance with federal and state securities laws.

SECTION 7. Mergers, Consolidation, Sales . In the case of any proposed consolidation or merger of the Company with another entity, or the proposed sale of all or substantially all of its

 

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assets to another person or entity, or any proposed reorganization or reclassification of the capital stock of the Company, then, as a condition of such consolidation, merger, sale, reorganization or reclassification, lawful and adequate provision shall be made whereby the Holder of this Warrant shall thereafter have the right to receive upon the basis and upon the terms and conditions specified herein, in lieu of the shares of the Common Stock of the Company immediately theretofore purchasable hereunder, such shares of stock, securities or assets as may (by virtue of such consolidation, merger, sale, reorganization or reclassification) be issued or payable with respect to or in exchange for the number of shares of such Common Stock purchasable hereunder immediately before such consolidation, merger, sale, reorganization or reclassification. In any such case appropriate provision shall be made with respect to the rights and interests of the Holder of this Warrant to the end that the provisions hereof shall thereafter be applicable as nearly as may be, in relation to any shares of stock, securities or assets thereafter deliverable upon the exercise of this Warrant. In the case of any proposed consolidation or merger of the Company with another entity, or the proposed sale of all or substantially all of its assets to another person or entity, or any proposed reorganization or reclassification of the capital stock of the Company in which the holders of the Company’s Common Stock are to receive assets in exchange for shares of Common Stock, then, as a condition of such consolidation, merger, sale, reorganization or reclassification, lawful and adequate provision shall be made whereby the Holder of this Warrant shall have the opportunity to exercise this Warrant at the time of such consolidation, merger, sale, reorganization or reclassification and receive upon the basis and upon the terms and conditions specified herein, in lieu of the shares of the Common Stock of the Company immediately theretofore purchasable hereunder, such assets as may (by virtue of such consolidation, merger, sale, reorganization or reclassification) be issued or payable with respect to or in exchange for the number of shares of such Common Stock purchasable hereunder immediately before such consolidation, merger, sale, reorganization or reclassification.

SECTION 8. Notice of Dissolution or Liquidation . In case of any distribution of the assets of the Company in dissolution or liquidation (except under circumstances when the foregoing Section 7 shall be applicable), the Company shall give notice thereof to the Holder hereof and shall make no distribution to shareholders until the expiration of thirty (30) days from the date of mailing of the aforesaid notice and, in any case, the Holder hereof may exercise this Warrant prior to the expiration date hereof within thirty (30) days from the date of the giving of such notice, and all rights herein granted not so exercised within such thirty-day period shall thereafter become null and void.

SECTION 9. Notice of Extraordinary Dividends . If the Board of Directors of the Company shall declare any dividend or other distribution on its Common Stock except out of earned surplus or by way of a stock dividend payable in shares of its Common Stock, the Company shall mail notice thereof to the Holder hereof not less than 30 days prior to the record date fixed for determining shareholders entitled to participate in such dividend or other distribution, and the Holder hereof shall not participate in such dividend or other distribution unless this Warrant is exercised prior to such record date. The provisions of this Section 9 shall not apply to distributions made in connection with transactions covered by Section 7.

SECTION 10. Fractional Shares . Fractional shares shall not be issued upon the exercise of this Warrant but in any case where the Holder would, except for the provisions of this Section 10, be entitled under the terms hereof to receive a fractional share upon the complete exercise of this

 

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Warrant, the Company shall, upon the exercise of this Warrant for the largest number of whole shares then called for, pay a sum in cash equal to the excess of the value of such fractional share (determined in such reasonable manner as may be prescribed in good faith by the Board of Directors of the Company) over the Warrant Price for such fractional share.

SECTION 11. Special Arrangements of the Company . The Company covenants and agrees that during the Term of this Warrant, unless otherwise approved by the Holder of this Warrant:

11.1. Will Not Amend Certificate . The Company will not amend its Certificate of Incorporation to eliminate as an authorized class of capital stock that class denominated as “Common Stock” on the date hereof.

11.2. Will Bind Successors . This Warrant shall be binding upon any Company or other person or entity succeeding to the Company by merger, consolidation or acquisition of all or substantially all of the Company’s assets.

SECTION 12. Registration Rights . The Company, the Holder and certain other parties have executed and delivered a Registration Rights Agreement dated as of February 3, 2000 (the “Registration Rights Agreement” ), pursuant to which the Company has granted certain registration and other rights to the other parties thereto. The Company hereby agrees that the Warrant Shares shall be entitled to the same rights as Conversion Shares in the Registration Rights Agreement, as if the Warrant Shares were Conversion Shares, except that (a) the Warrant Shares shall not be included in calculating the number of Conversion Shares for purposes of voting and exercising demand rights under the Registration Rights Agreement and shall not be entitled to vote or make a demand and (b) the Warrant Shares shall be reduced from an underwritten public offering under the provisions of Section 5 of the Registration Rights Agreement prior to the reduction of any Conversion Shares.

SECTION 13. Put . The Company agrees that this Warrant and the Warrant Shares are securities covered by and entitled to the rights contained in Section 5.37 of the Series B Convertible Preferred Stock Purchase Agreement dated as of February 3, 2000 among the Company, the Holder and certain other parties.

SECTION 14. Notices . Any notice or other document required or permitted to be given or delivered to the Holder shall be delivered at, or sent by certified or registered mail to, the Holder at 999 West Street, Rocky Hill, CT 06067 or to such other address as shall have been furnished to the Company in writing by the Holder. Any notice or other document required or permitted to be given or delivered to the Company shall be delivered at, or sent by certified or registered mail to, the Company at 300 George Street New Haven, CT 06511 or to such other address as shall have been furnished in writing to the Holder by the Company. Any notice so addressed and mailed by registered or certified mail shall be deemed to be given when so mailed. Any notice so addressed and otherwise delivered shall be deemed to be given when actually received by the addressee.

SECTION 15. No Rights as Stockholder; Limitation of Liability . This Warrant shall not entitle the Holder to any of the rights of a shareholder of the Company. No provision hereof, in the absence of affirmative action by the Holder to purchase shares of Common Stock, and no mere

 

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enumeration herein of the rights or privileges of the Holder, shall give rise to any liability of the Holder for the Warrant Price hereunder or as a shareholder of the Company, whether such liability is asserted by the Company or by creditors of the Company.

SECTION 16. Acknowledgment of Continuing Obligation . The Company will, at the time of any exercise of this Warrant in whole or in part, upon request of the holder hereof, acknowledge in writing its continuing obligation to such holder in respect of any rights (including without limitation any right to registration of the shares of Common Stock issued upon such exercise) to which such holder shall continue to be entitled after such exercise in accordance with this Warrant; provided , however , that the failure of such holder to make any such request shall not affect the continuing obligation of the Company to such holder in respect of such rights.

SECTION 17. Representations and Warranties . The Company hereby represents and warrants to the holder hereof as follows:

(a) The Company is a corporation duly incorporated, validly existing and in good standing under the laws of the State of Delaware, has the corporate power and authority to conduct its business as presently conducted, has the corporate power and authority to execute, issue and deliver this Warrant and to perform its obligations under this Warrant, has the corporate power and authority and legal right to own and lease its properties and is duly qualified and in good standing as a foreign corporation in each jurisdiction in which it owns or leases real property or in which the conduct of its business requires such qualification, except where failure to be so qualified could not be reasonably expected to have a material adverse effect on the Company and its subsidiaries taken as a whole.

(b) The execution, delivery, issuance and performance by the Company of this Warrant and the issuance of the Warrant Shares upon exercise of this Warrant have been duly authorized by all necessary corporate action and do not and will not violate, or result in a breach of, or constitute a default under, or require any consent under, or result in the creation of any lien, charge or encumbrance upon the assets of the Company pursuant to, any law, statute, ordinance, rule, regulation, order or decree of any court, governmental body or regulatory authority or administrative agency having jurisdiction over the Company or its subsidiaries or any contract, mortgage, loan agreement, note, lease or other instrument binding upon the Company or its subsidiaries or by which their properties are bound.

(c) This Warrant has been duly executed, issued and delivered by the Company and constitutes a legal, valid, binding and enforceable obligation of the Company. The Warrant Shares, when issued upon exercise of this Warrant in accordance with the terms hereof, will be duly authorized, validly issued, fully paid and nonassessable shares of Common Stock, with no personal liability attaching to the ownership thereof.

(d) The Company has authorized capital stock consisting of (x) 27,000,000 shares of Common Stock, $.001 par value, of which 1,769,427 shares are issued and outstanding, and (y) 31,883,332 shares of Preferred Stock, $.01 par value, of which (i) 250,000 shares are designated as Series A Convertible Preferred Stock, of which all shares are issued and outstanding, (ii) 15,816,666 shares are designated as Series B Convertible Preferred Stock, of which all shares are issued and outstanding and (iii) 15,816,666 shares are designated as Series B-1 Convertible Preferred Stock, of which zero (0) shares are issued and outstanding.

 

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SECTION 18. Law Governing . This Warrant shall be governed by, and construed and enforced in accordance with, the laws of the State of Connecticut, without giving effect to its conflict of laws principles.

SECTION 19. Miscellaneous . This Warrant and any provision hereof may be changed, waived, discharged or terminated only by an instrument in writing signed by the party (or any predecessor in interest thereof) against which enforcement of the same is sought. The headings in this Warrant are for purposes of reference only and shall not affect the meaning or construction of any of the provisions hereof.

Signature page to follow

 

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IN WITNESS WHEREOF, the Company has caused this Warrant to be signed by its duly authorized officer as of the date first written above.

 

 

ACHILLION PHARMACEUTICALS, INC.
By:  

/s/ William G. Rice

  William G. Rice, Ph. D.
  Its President
  Duly Authorized

 

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FORM OF NOTICE OF EXERCISE

[To be signed only upon exercise of the Warrant]

TO BE EXECUTED BY THE REGISTERED HOLDER

TO EXERCISE THE WITHIN WARRANT

The undersigned hereby exercises the right to purchase                      shares of Common Stock which the undersigned is entitled to purchase by the terms of the within Warrant according to the conditions thereof, and herewith makes payment of the Warrant Price of such shares in full. All shares to be issued pursuant hereto shall be issued in the name of, and the initial address of such person to be entered on the books of the Company shall be:

 

 

 

_________________________________

 
 

 

_________________________________

 
 

 

_________________________________

 

The shares are to be issued in certificates of the following denominations:

 

 

[Type Name of Holder]
By:  

 

Title:  

 

Dated:                     


FORM OF ASSIGNMENT

(ENTIRE)

[To be signed only upon transfer of entire Warrant]

TO BE EXECUTED BY THE REGISTERED HOLDER

TO TRANSFER THE WITHIN WARRANT

FOR VALUE RECEIVED                      hereby sells, assigns and transfers unto                      all rights of the undersigned under and pursuant to the within Warrant, and the undersigned does hereby irrevocably constitute and appoint                      Attorney to transfer the said Warrant on the books of the Company, with full power of substitution.

 

 

 
[Type Name of Holder]
By:  

 

Title:  

 

Dated:                     

NOTICE

The signature to the foregoing Assignment must correspond to the name as written upon the face of the within Warrant in every particular, without alteration or enlargement or any change whatsoever.


FORM OF ASSIGNMENT

(PARTIAL)

[To be signed only upon partial transfer of Warrant]

TO BE EXECUTED BY THE REGISTERED HOLDER

TO TRANSFER THE WITHIN WARRANT

FOR VALUE RECEIVED                      hereby sells, assigns and transfers unto                      (i) the rights of the undersigned to purchase          shares of Common Stock under and pursuant to the within Warrant, and (ii) on a non-exclusive basis, all other rights of the undersigned under and pursuant to the within Warrant, it being understood that the undersigned shall retain, severally (and not jointly) with the transferee(s) named herein, all rights assigned on such non-exclusive basis. The undersigned does hereby irrevocably constitute and appoint                      Attorney to transfer the said Warrant on the books of the Company, with full power of substitution.

 

 

[Type Name of Holder]
By:  

 

Title:  

 

Dated:                     

NOTICE

The signature to the foregoing Assignment must correspond to the name as written upon the face of the within Warrant in every particular, without alteration or enlargement or any change whatsoever.


THESE SECURITIES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR ANY STATE SECURITIES LAWS. THEY MAY NOT BE SOLD OR OFFERED FOR SALE IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT AS TO THE SECURITIES UNDER SAID ACT AND ANY APPLICABLE STATE SECURITIES LAWS OR THE AVAILABILITY OF AN EXEMPTION FROM REGISTRATION UNDER SAID ACT AND ANY APPLICABLE STATE SECURITIES LAWS.

STOCK SUBSCRIPTION WARRANT

To Initially Purchase 108,667 Shares of Common Stock of

ACHILLION PHARMACEUTICALS, INC. (the “Company”)

DATE OF INITIAL ISSUANCE: March 30, 2001

THIS CERTIFIES THAT for value received, CONNECTICUT INNOVATIONS , INCORPORATED or its registered assigns (the “ Holder ”) is entitled to purchase from the Company, at any time during the Term of this Warrant, initially One Hundred Eight Thousand Six Hundred Sixty Seven (108,667) shares (the “Initial Warrant Shares ) of common stock, $.001 par value, of the Company (the “Common Stock ), and, upon the occurrence of certain events, additional Contingent Warrant Shares (as defined below) at the applicable Warrant Price, payable in lawful money of the United States of America to be paid upon the exercise hereof. The exercise of this Warrant shall be subject to the provisions, limitations and restrictions herein contained, and may be exercised in whole or in part.

SECTION 1. Definitions .

For all purposes of this Warrant, the following terms shall have the meanings indicated:

Contingent Warrant Shares – shall mean shares of Common Stock purchasable hereunder at each time the Company borrows money directly from the Holder pursuant to section 2.2.1 of the Loan Agreement, dated March 30, 2001, between the Company and the Holder ( a “Borrowing” ). For each Borrowing, the number of such Contingent Warrant Shares subject to this Warrant shall be equal to the amount of such Borrowing divided by 10 divided by the Warrant Price applicable to such Contingent Warrant Shares. While the exercisability of Contingent Warrant Shares shall be automatic upon a Borrowing, the Company will execute when requested upon or after each Borrowing an acknowledgement to the Holder regarding such exercisability, the number of Contingent Warrant Shares and the Warrant Price applicable thereto.

Common Stock - shall mean and include the Company’s authorized Common Stock, $.001 par value, as constituted at the date hereof.

Current Market Price - shall mean, at any date and with respect to one share of Common Stock, the average of the daily closing prices for the 30 consecutive business days ending five business days before the day in question (as adjusted for any stock dividend, split, combination or


reclassification that took effect during such 30 business day period). The closing price for each day shall be the last reported sales price or, in case no such reported sales took place on such day, the average of the last reported bid and asked prices, in either case on the principal national securities exchange on which the Common Stock is listed or admitted to trading or as reported by Nasdaq (or if the Common Stock is not at the time listed or admitted for trading on any such exchange or if prices of the Common Stock are not reported by Nasdaq then such price shall be equal to the average of the last reported bid and asked prices on such day as reported by The National Quotation Bureau Incorporated or any similar reputable quotation and reporting service, if such quotation is not reported by The National Quotation Bureau Incorporated); provided, however, that if the Common Stock is not traded in such manner that the quotations referred to herein are available for the period required hereunder, the Current Market Price shall be determined in good faith by the Board of Directors of the Company or, if such determination cannot be made, by a nationally recognized independent investment banking firm selected by the Board of Directors of the Company (or if such selection cannot be made, by a nationally recognized independent investment banking firm selected by the American Arbitration Association in accordance with its rules).

Exchange Act - shall mean the Securities Exchange Act of 1934, as amended from time to time.

Securities Act - shall mean the Securities Act of 1933, as amended.

Term of this Warrant - shall mean the period beginning on the date of initial issuance hereof and ending on March 30, 2011.

Warrant Price – shall mean:

(a) for the Initial Warrant Shares $1.50 per share, subject to adjustment in accordance with Section 5 hereof, and

(b) for each Contingent Warrant Share shall mean the greater of:

(i) $1.50 per share ( the “Fixed Contingent Warrant Price”); or

(ii) at the time that such Contingent Warrant Share becomes exercisable hereunder the greater of:

(x) the price, if applicable, at which shares of capital stock of the Company were most recently issued by the Company in a private financing in which the Company received gross proceeds of at least $10,000,000; or

(y) the then lowest conversion price, if applicable, of Company convertible preferred stock then issued and outstanding,

and such Warrant Price as determined in this subsection (b) shall be subject to adjustment pursuant to Section 5 hereof.

 

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Warrant Shares shall mean, collectively, the Initial Warrant Shares and the Contingent Warrant Shares.

 

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SECTION 2. Exercise of Warrant .

2.1. Procedure for Exercise of Warrant . To the extent exercisable, the Holder may exercise this Warrant in whole or in part (but not as to any fractional share of Common Stock), by delivering to the Company at its office referred to in Section 14 hereof at any time and from time to time during the Term of this Warrant: (i) the Notice of Exercise in the form attached hereto, (ii) cash, certified or official bank check payable to the order of the Company, wire transfer of funds to the Company’s account, or evidence of any indebtedness of the Company to the Holder (or any combination of any of the foregoing) in the amount of the Warrant Price for each share being purchased, and (iii) this Warrant. Upon each such exercise, the Holder shall indicate whether it is exercising Initial Warrant Shares, Contingent Warrant Shares or a combination thereof. In addition, the Holder shall have the right at any time after Contingent Warrant Shares become exercisable to cause the Company to replace this Warrant with separate warrants, one covering Initial Warrant Shares and the other(s) covering each group of Contingent Warrant Shares having the same Warrant Price.

Notwithstanding any provisions herein to the contrary, if the Current Market Price is greater than the applicable Warrant Price (at the date of calculation, as set forth below), in lieu of exercising this Warrant as hereinabove permitted, the Holder may elect to receive shares of Common Stock for each Warrant Share (such computed shares then combined into an aggregate number of shares) equal to the value (as determined below) of each Warrant Share by surrender of this Warrant at the office of the Company referred to in Section 14 hereof, together with the Notice of Exercise, in which event the Company shall issue to the Holder that number of shares of Common Stock computed using the following formula:

CS = (CMP-WP)

  CMP

where:

CS equals the number of shares of Common Stock to be issued to the Holder for each Warrant Share;

CMP equals the Current Market Price (at the date of such calculation); and

WP equals the applicable Warrant Price (as adjusted to the date of such calculation).

In the event of any exercise of the rights represented by this Warrant, a certificate or certificates for the shares of Common Stock so purchased, registered in the name of the Holder or such other name or names as may be designated by the Holder, shall be delivered to the Holder hereof within a reasonable time, not exceeding fifteen days, after the rights represented by this Warrant shall have been so exercised; and, unless this Warrant has expired, a new Warrant representing the number of shares (except a remaining fractional share), if any, with respect to which this Warrant shall not then have been exercised shall also be issued to the Holder hereof within such time. The person in whose name any certificate for shares of Common Stock is issued upon exercise of this Warrant shall for all purposes be deemed to have become the holder of record of such shares on the date on

 

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which the Warrant was surrendered and payment of the applicable Warrant Price and any applicable taxes was made, irrespective of the date of delivery of such certificate, except that, if the date of such surrender and payment is a date when the stock transfer books of the Company are closed, such person shall be deemed to have become the holder of such shares at the close of business on the next succeeding date on which the stock transfer books are open.

2.2. Transfer Restriction Legend . Each certificate for Warrant Shares shall bear the following legend (and any additional legend required by (i) any applicable state securities laws and (ii) any securities exchange upon which such Warrant Shares may, at the time of such exercise, be listed) on the face thereof unless at the time of exercise such Warrant Shares shall be registered under the Securities Act:

THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE BEEN ACQUIRED FOR INVESTMENT AND HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933. THESE SECURITIES MAY NOT BE SOLD OR TRANSFERRED IN THE ABSENCE OF SUCH REGISTRATION OR AN EXEMPTION THEREFROM UNDER SAID ACT.

Any certificate issued at any time in exchange or substitution for any certificate bearing such legend (except a new certificate issued upon completion of a public distribution under a registration statement of the securities represented thereby) shall also bear such legend unless, in the opinion of counsel for the holder thereof (which counsel shall be reasonably satisfactory to counsel for the Company) the securities represented thereby are not, at such time, required by law to bear such legend.

SECTION 3. Covenants as to Common Stock . The Company covenants and agrees that all shares of Common Stock that may be issued upon the exercise of the rights represented by this Warrant will, upon issuance, be validly issued, fully paid and nonassessable, and free from all taxes (other than income taxes that may be payable by the Holder), liens and charges with respect to the issue thereof. Without limiting the generality of the foregoing, the Company covenants that it will from time to time take all such action as may be requisite to assure that the stated or par value per share, if any, of the Common Stock is at all times equal to or less than the then Warrant Price. The Company further covenants and agrees that it will pay when due and payable any and all federal and state taxes which may be payable in respect of the issue of this Warrant or any Common Stock or certificates therefor issuable upon the exercise of this Warrant. The Company further covenants and agrees that the Company will at all times have authorized and reserved, free from preemptive rights, a sufficient number of shares of Common Stock to provide for the exercise of the rights represented by this Warrant. The Company further covenants and agrees that if any shares of capital stock to be reserved for the purpose of the issuance of shares upon the exercise of this Warrant require registration with or approval of any governmental authority under any federal or state law before such shares may be validly issued or delivered upon exercise, then the Company will in good faith and as expeditiously as possible endeavor to secure such registration or approval, as the case may be. If and so long as the Common Stock issuable upon the exercise of this Warrant is listed on any national securities exchange, the Company will, if permitted by the rules of such exchange, list and keep listed on such exchange, upon official notice of issuance, all shares of such Common Stock issuable upon exercise of this Warrant. The Company shall take no action which would cause any

 

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changes in the Common Stock as to which an appropriate adjustment in the number of Warrant Shares and Warrant Price could not be readily made pursuant to the intent of Sections 4 and 5 hereof.

SECTION 4. Adjustment of Number of Shares . Upon each adjustment of each applicable Warrant Price as provided in Section 5, the Holder shall thereafter be entitled to purchase, at the Warrant Price resulting from such adjustment, the number of shares (calculated to the nearest tenth of a share) obtained by multiplying the applicable Warrant Price in effect immediately prior to such adjustment by the number of shares purchasable pursuant hereto immediately prior to such adjustment and dividing the product thereof by the Warrant Price resulting from such adjustment.

SECTION 5. Adjustment of Warrant Price . Each Warrant Price shall be subject to adjustment from time to time as follows:

(i) Economic Diluting Issuances .

(i) If the Company shall at any time or from time to time during the Term of this Warrant issue shares of Common Stock other than Excluded Stock (as hereinafter defined) without consideration or for a consideration per share less than the Warrant Price in effect immediately prior to the issuance of such Common Stock (a “ Diluting Issuance”), the Warrant Price in effect immediately prior to each such issuance or adjustment shall forthwith be adjusted to a price equal to the quotient obtained by dividing:

(A) an amount equal to the sum of

(x) the total number of shares of Common Stock outstanding (including any shares of Common Stock deemed to have been issued pursuant to subdivision (3) of this clause (i) and to clause (ii) below) immediately prior to such issuance multiplied by the Warrant Price in effect immediately prior to such issuance, plus

(y) the consideration received by the Company upon such issuance,

by

(B) the total number of shares of Common Stock outstanding (including any shares of Common Stock deemed to have been issued pursuant to subdivision (3) of this clause (i) and to clause (ii) below) immediately after the issuance of such Common Stock.

For the purposes of any adjustment of the Warrant Price pursuant to this clause (i), the following provisions shall be applicable:

1. In the case of the issuance of Common Stock for cash, the consideration shall be deemed to be the amount of cash paid therefor prior to deducting therefrom any discounts, commissions or other expenses allowed, paid or incurred by the Company for any underwriting or otherwise in connection with the issuance and sale thereof.

 

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2. In the case of the issuance of Common Stock for a consideration in whole or in part other than cash, the consideration other than cash shall be deemed to be the fair market value thereof as determined by the Board of Directors of the Company, irrespective of any accounting treatment.

3. In the case of the issuance of (i) options to purchase or rights to subscribe for Common Stock, (ii) securities by their terms convertible into or exchangeable for Common Stock or (iii) options to purchase or rights to subscribe for such convertible or exchangeable securities:

(A) the aggregate maximum number of shares of Common Stock deliverable upon exercise of such options to purchase or rights to subscribe for Common Stock shall be deemed to have been issued at the time such options or rights were issued and for a consideration equal to the consideration (determined in the manner provided in subdivisions (1) and (2) above), if any, received by the Company upon the issuance of such options or rights plus the minimum purchase price provided in such options or rights for the Common Stock covered thereby;

(B) the aggregate maximum number of shares of Common Stock deliverable upon conversion of or in exchange for any such convertible or exchangeable securities or upon the exercise of options to purchase or rights to subscribe for such convertible or exchangeable securities and subsequent conversions or exchanges thereof shall be deemed to have been issued at the time such securities were issued or such options or rights were issued and for a consideration equal to the consideration received by the Company for any such securities and related options or rights (excluding any cash received on account of accrued interest or accrued dividends), plus the additional consideration, if any, to be received by the Company upon the conversion or exchange of such securities or the exercise of any related options or rights (the consideration in each case to be determined in the manner provided in subdivisions (1) and (2) above);

(C) on any change in the number of shares of Common Stock deliverable upon exercise of any such options or rights or conversion of or exchange for such convertible or exchangeable securities, other than a change resulting from the antidilution provisions thereof, the Warrant Price shall forthwith be readjusted to such Warrant Price as would have obtained had the adjustment made upon the issuance of such options, rights or securities not converted prior to such change or options or rights related to such securities not converted prior to such change being made upon the basis of such change; and

(D) on the expiration of any such options or rights, the termination of any such rights to convert or exchange or the expiration of any options or rights related to such convertible or exchangeable securities, the Warrant Price shall

 

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forthwith be readjusted to such Warrant Price as would have obtained had the adjustment made upon the issuance of such options, rights, securities or options or rights related to such securities being made upon the basis of the issuance of only the number of shares of Common Stock actually issued upon the conversion or exchange of such securities or upon the exercise of the options or rights related to such securities.

(ii) “ Excluded Stock ” shall mean shares of Common Stock described in Section D.5.E. of Article IV of the Amended and Restated Certificate of Incorporation of the Company dated as of January 28, 2000, as amended October 16, 2000, as such Section D.5.E. may hereafter be amended.

(iii) Stock Dividends, Subdivisions, Split-Ups . If, at any time during the Term of this Warrant, the number of shares of Common Stock outstanding is increased by a stock dividend payable in shares of Common Stock or by a subdivision or split-up of shares of Common Stock (collectively a “ Split ”), then, following the record date fixed for the determination of holders of Common Stock entitled to receive such Split, the Warrant Price shall be appropriately decreased so that the number of shares of Common Stock issuable upon the exercise hereof shall be increased in proportion to such increase in outstanding shares.

(iv) Stock Combinations . If, at any time during the Term of this Warrant, the number of shares of Common Stock outstanding is decreased by a combination of the outstanding shares of Common Stock (a “ Combination ”), then, following the record date for such Combination, the Warrant Price shall appropriately increase so that the number of shares of Common Stock issuable upon the exercise hereof shall be decreased in proportion to such decrease in outstanding shares.

(v) Certain Dividends . If, at any time during the Term of this Warrant, the Company shall declare a cash dividend upon its Common Stock payable otherwise than out of earnings or earned surplus or shall distribute to holders of its Common Stock shares of its capital stock (other than Common Stock), stock or other securities of other persons, evidences of indebtedness issued by the Company or other persons, assets (excluding cash dividends and distributions) or options or rights (excluding options to purchase and rights to subscribe for Common Stock or other securities of the Company convertible into or exchangeable for Common Stock) (collectively, “ Dividend Issuance ”), then, in each such case, immediately following the record date fixed for the determination of the holders of Common Stock entitled to receive such Dividend Issuance, the Warrant Price in effect thereafter shall be determined by multiplying the Warrant Price in effect immediately prior to such record date by a fraction of which the numerator shall be an amount equal to the difference of (x) the Current Market Price of one share of Common Stock minus (y) the fair market value (as determined by the Board of Directors of the Company, whose determination shall be conclusive) of the stock, securities, evidences of indebtedness, assets, options or rights so distributed in respect of one share of Common Stock, and of which the denominator shall be such Current Market Price.

(vi) All calculations under this Section 5 shall be made to the nearest cent or to the nearest one-tenth (1/10) of a share, as the case may be.

 

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(vii) Whenever either Warrant Price shall be adjusted as provided in Section 5, the Company shall prepare a statement showing the facts requiring such adjustment and the Warrant Price that shall be in effect after such adjustment. The Company shall cause a copy of such statement to be sent by mail, first class postage prepaid, to each Holder of this Warrant at its, his or her address appearing on the Company’s records. Where appropriate, such copy may be given in advance and may be included as part of the notice required to be mailed under the provisions of subsection (ix) of this Section 5.

(viii) Adjustments made pursuant to clauses (iii), (iv) and (v) above shall be made on the date such dividend, subdivision, split-up, combination or distribution, as the case may be, is made, and shall become effective at the opening of business on the business day next following the record date for the determination of stockholders entitled to such dividend, subdivision, split-up, combination or distribution.

(ix) In the event the Company shall propose to take any action of the types described in clauses (iii), (iv) or (v) of this Section 5, the Company shall forward, at the same time and in the same manner, to the Holder of this Warrant such notice, if any, which the Company shall give to the holders of capital stock of the Company.

(x) In any case in which the provisions of this Section 5 shall require that an adjustment shall become effective immediately after a record date for an event, the Company may defer until the occurrence of such event issuing to the Holder of all or any part of this Warrant which is exercised after such record date and before the occurrence of such event the additional shares of capital stock issuable upon such exercise by reason of the adjustment required by such event over and above the shares of capital stock issuable upon such exercise before giving effect to such adjustment exercise; provided, however, that the Company shall deliver to such Holder a due bill or other appropriate instrument evidencing such Holder’s right to receive such additional shares upon the occurrence of the event requiring such adjustment.

(xi) The sale or other disposition of any Common Stock theretofore held in the treasury of the Company shall be deemed to be an issuance thereof.

(xii) The adjustments provided for in this Section 5 by reason of a Diluting Issuance, a Dividend Issuance, a Combination or a Split occurring prior to the time that Contingent Warrant Shares become exercisable shall be applicable only if the Warrant Price for such Contingent Warrant Shares is the Fixed Contingent Warrant Price (and whether the Warrant Price shall be the Fixed Contingent Warrant Price shall be determined after the Fixed Contingent Warrant Price has been adjusted as provided in Section 5).

SECTION 6. Ownership .

6.1 . Ownership of This Warrant . The Company may deem and treat the person in whose name this Warrant is registered as the holder and owner hereof (notwithstanding any notations of ownership or writing hereon made by anyone other than the Company) for all purposes

 

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and shall not be affected by any notice to the contrary until presentation of this Warrant for registration of transfer as provided in this Section 6.

6.2. Transfer and Replacement . Subject to the restrictions on transferability set forth in the Amended and Restated Stockholders’ Agreement dated as of February 3, 2000 among the Company, the Holder and certain other parties, this Warrant and all rights hereunder are transferable in whole or in part upon the books of the Company by the Holder hereof in person or by its duly authorized attorney, and a new Warrant or Warrants, of the same tenor as this Warrant but registered in the name of the transferee or transferees (and in the name of the Holder, if a partial transfer is effected) shall be made and delivered by the Company upon surrender of this Warrant duty endorsed, at the office of the Company referred to in Section 14 hereof. Upon receipt by the Company of evidence reasonably satisfactory to it of the loss, theft or destruction, and, in such case, of indemnity or security reasonably satisfactory to it, and upon surrender of this Warrant if mutilated, the Company will make and deliver a new Warrant of like tenor, in lieu of this Warrant; provided that if the Holder hereof is an instrumentality of a state or local government or an institutional holder or a nominee for such an instrumentality or institutional holder an irrevocable agreement of indemnity by such Holder shall be sufficient for all purposes of this Section 6, and no evidence of loss or theft or destruction shall be necessary. This Warrant shall be promptly cancelled by the Company upon the surrender hereof in connection with any transfer or replacement. Except as otherwise provided above, in the case of the loss, theft or destruction of a Warrant, the Company shall pay all expenses, taxes and other charges payable in connection with any transfer or replacement of this Warrant, other than stock transfer taxes (if any) payable in connection with a transfer of this Warrant, which shall be payable by the Holder. Holder will not transfer this Warrant and the rights hereunder except in compliance with federal and state securities laws.

SECTION 7. Mergers, Consolidation, Sales . In the case of any proposed consolidation or merger of the Company with another entity, or the proposed sale of all or substantially all of its assets to another person or entity, or any proposed reorganization or reclassification of the capital stock of the Company, then, as a condition of such consolidation, merger, sale, reorganization or reclassification, lawful and adequate provision shall be made whereby the Holder of this Warrant shall thereafter have the right to receive upon the basis and upon the terms and conditions specified herein, in lieu of the shares of the Common Stock of the Company immediately theretofore purchasable hereunder, such shares of stock, securities or assets as may (by virtue of such consolidation, merger, sale, reorganization or reclassification) be issued or payable with respect to or in exchange for the number of shares of such Common Stock purchasable hereunder immediately before such consolidation, merger, sale, reorganization or reclassification. In any such case appropriate provision shall be made with respect to the rights and interests of the Holder of this Warrant to the end that the provisions hereof shall thereafter be applicable as nearly as may be, in relation to any shares of stock, securities or assets thereafter deliverable upon the exercise of this Warrant. In the case of any proposed consolidation or merger of the Company with another entity, or the proposed sale of all or substantially all of its assets to another person or entity, or any proposed reorganization or reclassification of the capital stock of the Company in which the holders of the Company’s Common Stock are to receive assets in exchange for shares of Common Stock, then, as a condition of such consolidation, merger, sale, reorganization or reclassification, lawful and adequate provision shall be made whereby the Holder of this Warrant shall have the opportunity to exercise this Warrant at the time of such consolidation, merger, sale, reorganization or reclassification and

 

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receive upon the basis and upon the terms and conditions specified herein, in lieu of the shares of the Common Stock of the Company immediately theretofore purchasable hereunder, such assets as may (by virtue of such consolidation, merger, sale, reorganization or reclassification) be issued or payable with respect to or in exchange for the number of shares of such Common Stock purchasable hereunder immediately before such consolidation, merger, sale, reorganization or reclassification.

 

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SECTION 8. Notice of Dissolution or Liquidation . In case of any distribution of the assets of the Company in dissolution or liquidation (except under circumstances when the foregoing Section 7 shall be applicable), the Company shall give notice thereof to the Holder hereof and shall make no distribution to shareholders until the expiration of thirty (30) days from the date of mailing of the aforesaid notice and, in any case, the Holder hereof may exercise this Warrant prior to the expiration date hereof within thirty (30) days from the date of the giving of such notice, and all rights herein granted not so exercised within such thirty-day period shall thereafter become null and void.

SECTION 9. Notice of Extraordinary Dividends . If the Board of Directors of the Company shall declare any dividend or other distribution on its Common Stock except out of earned surplus or by way of a stock dividend payable in shares of its Common Stock, the Company shall mail notice thereof to the Holder hereof not less than 30 days prior to the record date fixed for determining shareholders entitled to participate in such dividend or other distribution, and the Holder hereof shall not participate in such dividend or other distribution unless this Warrant is exercised prior to such record date. The provisions of this Section 9 shall not apply to distributions made in connection with transactions covered by Section 7.

SECTION 10. Fractional Shares . Fractional shares shall not be issued upon the exercise of this Warrant but in any case where the Holder would, except for the provisions of this Section 10, be entitled under the terms hereof to receive a fractional share upon the complete exercise of this Warrant, the Company shall, upon the exercise of this Warrant for the largest number of whole shares then called for, pay a sum in cash equal to the excess of the value of such fractional share (determined in such reasonable manner as may be prescribed in good faith by the Board of Directors of the Company) over the Warrant Price for such fractional share.

SECTION 11. Special Arrangements of the Company . The Company covenants and agrees that during the Term of this Warrant, unless otherwise approved by the Holder of this Warrant:

11.1. Will Not Amend Certificate . The Company will not amend its Certificate of Incorporation to eliminate as an authorized class of capital stock that class denominated as “Common Stock” on the date hereof.

11.2. Will Bind Successors . This Warrant shall be binding upon any Company or other person or entity succeeding to the Company by merger, consolidation or acquisition of all or substantially all of the Company’s assets.

SECTION 12. Registration Rights . The Company, the Holder and certain other parties have executed and delivered a Registration Rights Agreement dated as of February 3, 2000 (the “Registration Rights Agreement”) , pursuant to which the Company has granted certain registration and other rights to the other parties thereto. The Company hereby agrees that the Warrant Shares shall be entitled to the same rights as Conversion Shares in the Registration Rights Agreement, as if the Warrant Shares were Conversion Shares, except that (a) the Warrant Shares shall not be included in calculating the number of Conversion Shares for purposes of voting and exercising demand rights under the Registration Rights Agreement and shall not be entitled to vote or make a demand and (b) the Warrant Shares shall be reduced from an underwritten public offering under the provisions of Section 5 of the Registration Rights Agreement prior to the reduction of any Conversion Shares.

 

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SECTION 13. Put . The Company agrees that this Warrant and the Warrant Shares are securities covered by and entitled to the rights contained in Section 5.37 of the Series B Convertible Preferred Stock Purchase Agreement dated as of February 3, 2000 among the Company, the Holder and certain other parties as if this Warrant and the Warrant Shares were purchased thereunder.

SECTION 14. Notices . Any notice or other document required or permitted to be given or delivered to the Holder shall be delivered at, or sent by certified or registered mail to, the Holder at 999 West Street, Rocky Hill, CT 06067 or to such other address as shall have been furnished to the Company in writing by the Holder. Any notice or other document required or permitted to be given or delivered to the Company shall be delivered at, or sent by certified or registered mail to, the Company at 300 George Street New Haven, CT 06511 or to such other address as shall have been furnished in writing to the Holder by the Company. Any notice so addressed and mailed by registered or certified mail shall be deemed to be given when so mailed. Any notice so addressed and otherwise delivered shall be deemed to be given when actually received by the addressee.

SECTION 15. No Rights as Stockholder; Limitation of Liability . This Warrant shall not entitle the Holder to any of the rights of a shareholder of the Company. No provision hereof, in the absence of affirmative action by the Holder to purchase shares of Common Stock, and no mere enumeration herein of the rights or privileges of the Holder, shall give rise to any liability of the Holder for the Warrant Price hereunder or as a shareholder of the Company, whether such liability is asserted by the Company or by creditors of the Company.

SECTION 16. Acknowledgment of Continuing Obligation . The Company will, at the time of any exercise of this Warrant in whole or in part, upon request of the holder hereof, acknowledge in writing its continuing obligation to such holder in respect of any rights (including without limitation any right to registration of the shares of Common Stock issued upon such exercise) to which such holder shall continue to be entitled after such exercise in accordance with this Warrant; provided , however , that the failure of such holder to make any such request shall not affect the continuing obligation of the Company to such holder in respect of such rights.

 

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SECTION 17. Representations and Warranties . The Company hereby represents and warrants to the holder hereof as follows:

(a) The Company is a corporation duly incorporated, validly existing and in good standing under the laws of the State of Delaware, has the corporate power and authority to conduct its business as presently conducted, has the corporate power and authority to execute, issue and deliver this Warrant and to perform its obligations under this Warrant, has the corporate power and authority and legal right to own and lease its properties and is duly qualified and in good standing as a foreign corporation in each jurisdiction in which it owns or leases real property or in which the conduct of its business requires such qualification, except where failure to be so qualified could not be reasonably expected to have a material adverse effect on the Company and its subsidiaries taken as a whole.

(b) The execution, delivery, issuance and performance by the Company of this Warrant and the issuance of the Warrant Shares upon exercise of this Warrant have been duly authorized by all necessary corporate action and do not and will not violate, or result in a breach of, or constitute a default under, or require any consent under, or result in the creation of any lien, charge or encumbrance upon the assets of the Company pursuant to, any law, statute, ordinance, rule, regulation, order or decree of any court, governmental body or regulatory authority or administrative agency having jurisdiction over the Company or its subsidiaries or any contract, mortgage, loan agreement, note, lease or other instrument binding upon the Company or its subsidiaries or by which their properties are bound.

(c) This Warrant has been duly executed, issued and delivered by the Company and constitutes a legal, valid, binding and enforceable obligation of the Company. The Warrant Shares, when issued upon exercise of this Warrant in accordance with the terms hereof, will be duly authorized, validly issued, fully paid and nonassessable shares of Common Stock, with no personal liability attaching to the ownership thereof.

(d) The Company has authorized capital stock consisting of (x) 27,000,000 shares of Common Stock, $.001 par value, of which 1,769,427 shares are issued and outstanding, and (y) 31,883,332 shares of Preferred Stock, $.01 par value, of which (i) 250,000 shares are designated as Series A Convertible Preferred Stock, of which all shares are issued and outstanding, (ii) 15,816,666 shares are designated as Series B Convertible Preferred Stock, of which all shares are issued and outstanding and (iii) 15,816,666 shares are designated as Series B-l Convertible Preferred Stock, of which no shares are issued and outstanding.

SECTION 18. Law Governing . This Warrant shall be governed by, and construed and enforced in accordance with, the laws of the State of Connecticut, without giving effect to its conflict of laws principles.

SECTION 19. Miscellaneous . This Warrant and any provision hereof may be changed, waived, discharged or terminated only by an instrument in writing signed by the party (or any predecessor in interest thereof) against which enforcement of the same is sought. The headings in this Warrant are for purposes of reference only and shall not affect the meaning or construction of any of the provisions hereof.

 

-14-


IN WITNESS WHEREOF, the Company has caused this Warrant to be signed by its duly authorized officer as of the date first written above.

 

ACHILLION PHARMACEUTICALS, INC.
By:  

/s/ William G. Rice

  William G. Rice, Ph. D.
 

Its President

Duly Authorized

 

-15-


FORM OF NOTICE OF EXERCISE

[To be signed only upon exercise of the Warrant]

TO BE EXECUTED BY THE REGISTERED HOLDER

TO EXERCISE THE WITHIN WARRANT

The undersigned hereby exercises the right to purchase                      shares of Common Stock which the undersigned is entitled to purchase by the terms of the within Warrant according to the conditions thereof, and herewith makes payment of the Warrant Price of such shares in full. All shares to be issued pursuant hereto shall be issued in the name of, and the initial address of such person to be entered on the books of the Company shall be:

 

 

 

_________________________________

 
 

 

_________________________________

 
 

 

_________________________________

 

The shares are to be issued in certificates of the following denominations:

 

 

[Type Name of Holder]
By:  

 

Title:  

 

Dated:                     


FORM OF ASSIGNMENT

(PARTIAL)

[To be signed only upon partial transfer of Warrant]

TO BE EXECUTED BY THE REGISTERED HOLDER

TO TRANSFER THE WITHIN WARRANT

FOR VALUE RECEIVED                      hereby sells, assigns and transfers unto                      (i) the rights of the undersigned to purchase          shares of Common Stock under and pursuant to the within Warrant, and (ii) on a non-exclusive basis, all other rights of the undersigned under and pursuant to the within Warrant, it being understood that the undersigned shall retain, severally (and not jointly) with the transferee(s) named herein, all rights assigned on such non-exclusive basis. The undersigned does hereby irrevocably constitute and appoint                      Attorney to transfer the said Warrant on the books of the Company, with full power of substitution.

 

 

 
[Type Name of Holder]
By:  

 

Title:  

 

Dated:                     

NOTICE

The signature to the foregoing Assignment must correspond to the name as written upon the face of the within Warrant in every particular, without alteration or enlargement or any change whatsoever.


FORM OF ASSIGNMENT

(ENTIRE)

[To be signed only upon transfer of entire Warrant]

TO BE EXECUTED BY THE REGISTERED HOLDER

TO TRANSFER THE WITHIN WARRANT

FOR VALUE RECEIVED                      hereby sells, assigns and transfers unto                      all rights of the undersigned under and pursuant to the within Warrant, and the undersigned does hereby irrevocably constitute and appoint                      Attorney to transfer the said Warrant on the books of the Company, with full power of substitution.

 

 

 
[Type Name of Holder]
By:  

 

Title:  

 

Dated:                     

NOTICE

The signature to the foregoing Assignment must correspond to the name as written upon the face of the within Warrant in every particular, without alteration or enlargement or any change whatsoever.


FORM OF ASSIGNMENT

(PARTIAL)

[To be signed only upon partial transfer of Warrant]

TO BE EXECUTED BY THE REGISTERED HOLDER

TO TRANSFER THE WITHIN WARRANT

FOR VALUE RECEIVED                      hereby sells, assigns and transfers unto                      (i) the rights of the undersigned to purchase          shares of Common Stock under and pursuant to the within Warrant, and (ii) on a non-exclusive basis, all other rights of the undersigned under and pursuant to the within Warrant, it being understood that the undersigned shall retain, severally (and not jointly) with the transferee(s) named herein, all rights assigned on such non-exclusive basis. The undersigned does hereby irrevocably constitute and appoint                      Attorney to transfer the said Warrant on the books of the Company, with full power of substitution.

 

 

 
[Type Name of Holder]
By:  

 

Title:  

 

Dated:                     

NOTICE

The signature to the foregoing Assignment must correspond to the name as written upon the face of the within Warrant in every particular, without alteration or enlargement or any change whatsoever.

Exhibit 23.1

 

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

We hereby consent to the use in this Registration Statement on Form S-1 of our report dated March 31, 2006, except for “Liquidity” in Note 1 as to which the date is May 12, 2006 and except for Note 14 as to which the date is September 18, 2006, relating to the financial statements of Achillion Pharmaceuticals, Inc., which appears in such Registration Statement. We also consent to the references to us under the headings “Experts” and “Selected Financial Data” in such Registration Statements.

 

/s/ PricewaterhouseCoopers LLP

 

Hartford, Connecticut

September 20, 2006