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As filed with the Securities and Exchange Commission on June 27, 2007

Registration No. 333- 142842

 


UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 


Amendment No. 1 to

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

 


TARGANTA THERAPEUTICS CORPORATION

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware   2834   20-3971077
(State of Incorporation)   (Primary Standard Industrial Classification Code Number)  

(I.R.S. Employer

Identification Number)

 


222 Third Street, Suite 2300

Cambridge, MA 02142-1122

(617) 577-9020

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

 


Mark Leuchtenberger

President and Chief Executive Officer

Targanta Therapeutics Corporation

222 Third Street, Suite 2300

Cambridge, MA 02142-1122

(617) 577-9020

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

 


Copies to:

 

William B. Asher, Esq.

Brian P. Lenihan, Esq.

Lee S. Feldman, Esq.

Choate Hall & Stewart LLP

Two International Place

Boston, Massachusetts 02110

(617) 248-5000

 

Donald J. Murray, Esq.

Dewey Ballantine LLP

1301 Avenue of the Americas

New York, NY 10019

(212) 259-8000

 


Approximate date of commencement of proposed sale to the public:

As soon as practicable after this registration statement becomes effective.

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

If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, 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.   ¨

 


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

 



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The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell nor does it seek an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

 

SUBJECT TO COMPLETION, DATED JUNE 27, 2007

                     Shares

LOGO

Common Stock

 


This is an initial public offering of shares of common stock of Targanta Therapeutics Corporation.

We are selling              shares of common stock in this offering.

Prior to this offering, there has been no public market for our common stock. The initial public offering price of the common stock is expected to be between $             and $             per share. We have applied to list our common stock on The Nasdaq Global Market under the symbol “TARG.”

The underwriters have an option to purchase a maximum of              additional shares to cover over-allotment of shares.

Investing in our common stock involves risks. See “ Risk Factors ” beginning on page 10.

 

      

Price to
Public

    

Underwriting
Discounts and
Commissions

    

Proceeds to
Targanta

Per Share

     $                  $                  $            

Total

     $                      $                      $                

Delivery of the shares of common stock will be made on or about             , 2007.

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

Sole Book-Running Manager

Credit Suisse

 


Cowen and Company

Lazard Capital Markets

Leerink Swann & Company

 

The date of this prospectus is                        , 2007.


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TABLE OF CONTENTS

 

     Page

P ROSPECTUS S UMMARY

   1

R ISK F ACTORS

   10

S PECIAL N OTE R EGARDING F ORWARD -L OOKING S TATEMENTS AND P ROJECTIONS

   34

U SE OF P ROCEEDS

   35

D IVIDEND P OLICY

   36

C APITALIZATION

   37

D ILUTION

   39

S ELECTED C ONSOLIDATED F INANCIAL D ATA

   41

M ANAGEMENT S D ISCUSSION AND A NALYSIS OF F INANCIAL C ONDITION AND R ESULTS OF O PERATIONS

   43

B USINESS

   67

M ANAGEMENT

   91
     Page

C ERTAIN R ELATIONSHIPS AND R ELATED P ARTY T RANSACTIONS

   117

P RINCIPAL S TOCKHOLDERS

   122

D ESCRIPTION OF C APITAL S TOCK

   126

M ATERIAL U NITED S TATES F EDERAL I NCOME AND E STATE T AX C ONSEQUENCES TO N ON -U.S. H OLDERS

   131

S HARES E LIGIBLE FOR F UTURE S ALE

   134

U NDERWRITING

   137

N OTICE TO I NVESTORS

   140

L EGAL M ATTERS

   144

E XPERTS

   144

W HERE Y OU C AN F IND M ORE I NFORMATION

   144

I NDEX TO C ONSOLIDATED F INANCIAL S TATEMENTS

   F-1

You should rely only on the information contained in this document or to which we have referred you. We have not authorized anyone to provide you with information that is different. This document may only be used where it is legal to sell these securities. The information contained in this document may only be accurate on the date of this document.

Until                     , 2007, all dealers that effect transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to the dealer’s obligation to deliver a prospectus when acting as an underwriter and with respect to unsold allotments or subscriptions.

Unless the context indicates otherwise, as used in this prospectus, the terms “Targanta,” “we,” “us” and “our” refer to Targanta Therapeutics Corporation and its subsidiaries. The name “Targanta” is our trademark. All other trademarks, trade names and service marks appearing in this prospectus are the property of their respective owners.


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PROSPECTUS SUMMARY

This summary highlights selected information contained elsewhere in this prospectus. This summary does not contain all of the information you should consider before investing in our common stock. You should read this entire prospectus carefully, especially the risks of investing in our common stock discussed under “Risk Factors” beginning on page 10, and the consolidated financial statements and notes to those consolidated financial statements, before making an investment decision.

Overview

Our Company

We are a biopharmaceutical company focused on the development and commercialization of innovative antibiotics for serious infections treated or acquired in hospitals and other institutional settings. We are developing oritavancin, a novel intravenous antibiotic, for the treatment of serious gram-positive bacterial infections, including complicated skin and skin structure infections, or cSSSI, and bacteremia, an infection caused by bacteria in the bloodstream. Gram-positive bacteria have evolved into strains that are highly resistant to many currently available antibiotics, creating an ever-evolving need for novel antibiotics that employ different mechanisms to control them. According to IMS Health, antibiotics designed to treat serious infections caused by resistant gram-positive bacteria accounted for approximately $945 million in United States sales in 2006 and this market is rapidly growing.

We expect to submit a new drug application (or NDA) with the United States Food and Drug Administration (or the FDA) seeking to commercialize oritavancin for the treatment of cSSSI in the first quarter of 2008 and hope to receive FDA regulatory approval in late 2008 in the United States and thereafter receive regulatory approval in Europe. We plan on commercializing oritavancin through our own direct sales force in the United States and in select other countries, and to out-license oritavancin to, or collaborate with, third parties in other countries as we deem appropriate. In addition to oritavancin, we have discovered another antibiotic that is currently in pre-clinical development for the treatment of osteomyelitis, and we continually evaluate opportunities for potential in-licensing of other antibiotics for the treatment of hospital-based infections.

We acquired worldwide rights to oritavancin from InterMune, Inc. in late 2005, and believe that, since then, we have greatly improved its commercial and economic prospects by resolving several important issues with the FDA and by substantially lowering the royalty rate that may be payable to Eli Lilly and Company, the original discoverer of oritavancin. Our strategy is to capitalize on the unique attributes of oritavancin to develop it into a leading therapy worldwide for the treatment of serious gram-positive infections, initially for cSSSI and subsequently for other indications.

Our Lead Product: Oritavancin

Oritavancin is a novel semi-synthetic glycopeptide antibiotic for the treatment of serious gram-positive infections. Oritavancin has completed two Phase 3 studies for the treatment of cSSSI in which the primary end points were successfully met. In addition, oritavancin has completed two Phase 2 trials for the treatment of bacteremia with successful outcomes. Oritavancin is synthetically modified from a naturally occurring compound, and was originally discovered and developed by Lilly to combat a broad spectrum of gram-positive pathogens in response to the emergence of pathogens resistant to vancomycin, the most commonly prescribed antibiotic for resistant gram-positive infections. Oritavancin is protected by intellectual property rights that we licensed from Lilly. The issued oritavancin patents and pending patent applications are part of an extensive world-wide patent estate that includes a composition of matter patent that runs in the United States through November 24, 2015, and, with the potential for obtaining extension of patent protection available under the Hatch-Waxman Act, we believe may run for up to an additional five years.

 

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As a glycopeptide (which is a short chain of amino acids with attached sugar molecules), oritavancin shares some properties of other members of the glycopeptide class of antibiotics, which includes vancomycin, the current standard of care for serious gram-positive infections in the United States and Europe, as well as telavancin, for which an NDA was submitted in 2006 by Theravance, Inc. However, we believe that oritavancin has advantages compared to other glycopeptides and other classes of gram-positive antibiotics, including the following:

 

   

Rapidly Bactericidal and Potentially Less Likely to Engender Resistance. Similar to other glycopeptides, oritavancin disrupts cell wall synthesis by bacteria. However, oritavancin inhibits two separate enzymes involved in cell wall synthesis while most other glycopeptides, including vancomycin, inhibit a single enzyme. Further, oritavancin also causes the rapid rupture of bacterial membranes, leading to significantly faster killing of the bacteria (known as bactericidal activity) as compared to vancomycin and other antibiotics. Taken together, these multiple mechanisms of action may reduce the potential for the emergence of strains of bacteria that are resistant to oritavancin as compared with other antibiotics. To date, no resistant strains have been observed in any clinical trials for oritavancin, and laboratory efforts to cultivate oritavancin-resistant bacteria have proved much less successful than is historically the case with most non-glycopeptide antibiotics.

 

   

Broad Spectrum Against Gram-Positive Bacteria . In-vitro testing indicates that, compared to other antibiotics, oritavancin treats the broadest spectrum of gram-positive pathogens, including organisms resistant to vancomycin and other antibiotics such as linezolid and daptomycin. Unlike vancomycin, in addition to killing actively dividing bacteria, oritavancin has been shown to kill quiescent or non-dividing bacteria, such as those found in biofilm, suggesting potential utility in treating endocarditis, as well as device and catheter related infections.

 

   

Superior In-Vitro Potency. We have performed in-vitro tests on over 8,000 recent bacterial clinical isolates, employing an assay accepted by both the FDA and the Clinical Laboratory Standards Institute (or CLSI), a national standards-developing organization. These tests show that the potency of oritavancin is up to 32 times greater than demonstrated in earlier testing done by Lilly and InterMune and that oritavancin has superior potency against a broad spectrum of gram-positive pathogens compared with tests conducted by us or published data on the potency of other antibiotics.

 

   

Lower Incidence of Adverse Events . Oritavancin has been shown in clinical trials to have a lower rate of adverse events than vancomycin, and its published adverse events rates compare favorably against those published for other antibiotics against resistant gram-positive infections. Unlike other glycopeptides, including vancomycin, telavancin and dalbavancin, oritavancin has not required, in clinical trials to date, monitoring for the purpose of adjusting the blood level of the glycopeptide due to hepatic or renal insufficiency. Further, unlike certain other antibiotics for gram-positive infections, oritavancin did not elevate muscle enzymes, and did not significantly prolong QT interval or cause other electrophysiological changes.

 

   

Favorable Elimination Profile. Unlike many other antibiotics, oritavancin is not metabolized and is slowly eliminated from the body as unchanged drug, substantially reducing the potential for adverse events such as renal toxicity or delayed hypersensitivity that might result from the presence of reactive metabolites.

 

   

Long Half-Life. The in-vivo half-life of oritavancin is significantly longer than the half-lives of most potential competitors. This enables oritavancin to be administered daily, or potentially less frequently. Oritavancin’s Phase 3 trials in cSSSI, for example, tested the compound in a regimen of one dose per day for only three to seven days, substantially less than the labeled or tested regimens of other antibiotics against gram-positive infections. We also believe that a higher dose of the drug may prove effective in treating cSSSI using a single administration, which may be useful in non-hospital institutional settings

 

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such as nursing homes, or for patients being discharged from hospitals. We plan to begin a Phase 2 study in 2007 and a Phase 3 study in 2008 to evaluate a single dose regimen of oritavancin for cSSSI. We believe that azithromycin, a long-acting antibiotic, has demonstrated that a long-acting antibiotic can be commercially successful once clinicians are convinced it has a benign adverse event profile.

 

   

Potential Efficacy in Bacteremia. Oritavancin has completed two Phase 2 studies in bacteremia with successful outcomes, including a Phase 2 study where vancomycin was used as the comparator. Based on these results, we plan to begin a Phase 3 bacteremia study in 2008. Many other antibiotics used against gram-positive pathogens are ineffective against bacteremia or have toxicities that may limit their use for longer durations.

As a result of these advantages, we believe that oritavancin could provide physicians with an efficacious and novel antibiotic for the treatment of serious gram-positive infections while providing significant pharmoeconomic benefits by reducing the need for patient monitoring and shortening hospital stays.

Oritavancin has been tested in over 1,500 patients and has completed two Phase 3 trials for the indication of cSSSI conducted by Lilly and InterMune. We believe that the completed Phase 3 trials should be sufficient for FDA approval of oritavancin for cSSSI due to the following:

 

   

Efficacy. Each Phase 3 clinical trial used a non-inferiority trial design and met the primary endpoint of non-inferiority, which is currently accepted by the FDA as the appropriate trial design for antibiotics that treat serious gram-positive infections. These trials compared oritavancin to an active control arm of vancomycin followed by cephalexin and showed that oritavancin was effective in an average of 5.3 days compared to 10.9 days for vancomycin / cephalexin.

 

   

Safety. In each of these Phase 3 trials, oritavancin was well tolerated and, compared to the control arms, exhibited a favorable safety profile and a lower discontinuation rate due to adverse events.

 

   

Favorable FDA Interactions. The FDA confirmed to us in writing in March 2007 that the non-inferiority design using an active control that was employed in both Phase 3 trials was appropriate for cSSSI. In addition, in three separate meetings, including our pre-NDA meeting on January 31, 2007 in which we specifically discussed the Phase 3 trials, the FDA has not requested that we perform additional clinical trials to demonstrate efficacy in cSSSI. Since the FDA’s accepted delta (difference in cure rates) for non-inferiority trials for antibiotics that treat serious infections like cSSSI (using a comparator like vancomycin) is now 10%, the FDA has requested that we provide justification, as part of our NDA, for the choice of the 15% non-inferiority delta previously accepted by the FDA for the first of these two Phase 3 trials. As part of this analysis, the FDA has requested that we provide information on the non-inferiority margin both in terms of the benefit of oritavancin as compared to historical vancomycin and placebo cure rates and in terms of acceptable loss of treatment effect relative to historical vancomycin and placebo cure rates (in a population as similar as possible to the population enrolled in these Phase 3 clinical trials). The FDA has indicated that this analysis will be critical to approval of our NDA.

Accomplishments Since We Acquired Oritavancin

We believe that we have greatly improved the commercial and economic prospects for oritavancin since we acquired worldwide rights to it in late 2005 from InterMune because of actions we have taken that include:

 

   

Regulatory . We have resolved certain outstanding regulatory issues for oritavancin. We submitted data to the FDA regarding a previous concern that, in two Phase 1 studies conducted by InterMune in 2003, oritavancin had an increased rate of injection-site phlebitis (or vascular inflammation). In January 2007,

 

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the FDA accepted our assessment of the data we had submitted and agreed to lift the voluntary clinical hold originally requested by InterMune in 2004. Further, the FDA did not object to our plan to file our NDA.

 

   

Potency . We have performed in-vitro potency tests on more than 8,000 recent bacterial isolates, employing an assay that has been accepted recently by the FDA and the national standards-developing organization CLSI. These tests show that oritavancin is as much as 32 times more potent than previously shown by Lilly and InterMune and has superior potency against a broad spectrum of gram-positive bacteria compared with tests conducted by us or published data on the potency of other antibiotics.

 

   

Economic . We were able to negotiate a substantially lower royalty obligation to Lilly than would have been payable to Lilly by InterMune, oritavancin’s previous licensee.

The Gram-Positive Antibiotic Market

There is a growing need for novel antibiotics because bacteria mutate quickly and often develop resistance to existing antibiotics. According to a July 2004 publication by the Infectious Diseases Society of America, approximately 70% of all bacterial infections resulting in hospitalization are now resistant to some form of antibiotic. According to IMS Health, antibiotics designed to treat serious infections caused by resistant gram-positive bacteria accounted for approximately $945 million in United States sales in 2006. According to IMS Health, the predominant treatment for resistant gram-positive bacteria is vancomycin, which currently accounts for approximately 85% of courses of therapy in the United States for antibiotic-resistant gram-positive pathogens. Use of vancomycin, a generic drug, has been declining in recent years due to its decreasing efficacy against resistant strains of gram-positive bacteria and the emergence of more attractive treatment options. Two other antibiotics comprise the majority of remaining sales in the resistant gram-positive market: Zyvox ® , which is known generically as linezolid and marketed by Pfizer; and Cubicin ® , which is known generically as daptomycin and marketed by Cubist Pharmaceuticals. However, bacterial resistance has already emerged to both of these drugs.

Based on recent market research we performed, we believe that significant unmet needs remain in the treatment of gram-positive infections. Based on this research, we learned that infectious disease physicians most desired greater efficacy, fewer side effects, fewer treatment issues and shorter hospital stays. We believe that oritavancin has advantages in all of these categories.

Our Strategy

We hold the worldwide rights to oritavancin and our strategy is to develop oritavancin into a leading therapy worldwide for the treatment of serious gram-positive infections, initially for the treatment of cSSSI and subsequently for other indications. Specifically, we plan to:

 

   

Obtain regulatory approval for oritavancin for the treatment of cSSSI in the United States;

 

   

Build a hospital-directed sales force to commercialize oritavancin in the United States;

 

   

Pursue clinical development of oritavancin in other dosing regimens and for additional indications;

 

   

Submit a marketing authorization application for oritavancin in the European Union (or the EU) and evaluate the potential for a blended commercialization strategy composed of proprietary sales and partnerships with third parties;

 

   

Out-license oritavancin to third parties for commercialization in key Asian countries; and

 

   

Pursue the development of other innovative antibiotics for the hospital market, either through in-licensing or internal development.

 

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Risks Related to Our Business

Our ability to implement our current business strategy is subject to numerous risks, as more fully described in the section entitled “Risk Factors” immediately following this prospectus summary. These risks include, among others, our dependence on the success of oritavancin; delays in obtaining, or a failure to obtain, regulatory approval for our product candidates; failure of any approved product to achieve significant commercial acceptance in the medical community or receive reimbursement by third-party payors; unfavorable clinical trial results; our dependence upon third parties under our licensing, contract research and manufacturing agreements; delays in product launch; and failure to maintain and protect our proprietary intellectual property assets. All of our product candidates are subject to regulatory approval by the FDA and comparable agencies in other countries. Oritavancin is our only product candidate presently in clinical development and has not yet received regulatory approval. We cannot give any assurance that it, or any other product candidates we may develop or acquire, will receive regulatory approval or be successfully commercialized.

We have not generated any revenue to date from product sales and have incurred significant operating losses since our inception in 1997. We incurred net losses of approximately $5.8 million and $5.3 million in fiscal years ended May 31, 2004 and 2005, respectively, $15.6 million for the seven months ended December 31, 2005, $30.1 million for the year ended December 31, 2006, and $18.7 million for the three months ended March 31, 2007. As of March 31, 2007, we had a deficit accumulated during the development stage of approximately $82.3 million, restated, and we expect to incur losses for the foreseeable future. The figures above for the fiscal years 2004, 2005 and 2006 and the seven months ended December 31, 2005 have been restated. 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 product candidates, we may never generate sufficient revenue to achieve and sustain profitability.

Corporate Information

We are incorporated as a Delaware corporation, effective December 6, 2005, with two subsidiaries in Canada and we initiated operations through our Canadian subsidiary in May 1997 in Montreal, Québec. In 2006, we relocated our principal executive offices to 222 Third Street, Suite 2300, Cambridge, Massachusetts 02142, where our telephone number is (617) 577-9020. We have additional sites in Indianapolis, Indiana, Montreal, Québec and Toronto, Ontario. Our web site address is http://www.targanta.com . The information contained in, or that can be accessed through, our website is not part of this prospectus and should not be considered part of this prospectus.

 

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THE OFFERING

 

Common stock offered by us

             shares

 

Common stock to be outstanding after this offering

             shares

 

Use of proceeds

We expect to receive net proceeds from the offering of approximately $             million. We intend to use the proceeds from the offering as follows:

 

   

to fund internal and external costs in connection with our anticipated NDA submission for oritavancin in the United States and for other regulatory filings thereafter in Europe;

 

   

to fund clinical trials for oritavancin in cSSSI using a single administration and to continue the clinical development of oritavancin for other indications such as bacteremia;

 

   

to fund commercial launch-related expenses for oritavancin including manufacturing, marketing, and sales in anticipation of regulatory approval;

 

   

to make regularly scheduled payments on existing debt facilities;

 

   

to apply the remaining funds for general corporate purposes and the potential acquisition of, or investment in, technologies, products, or companies that complement our business.

For further information, see “Use of Proceeds.”

 

Proposed Nasdaq Global Market symbol

“TARG”

The number of shares of our common stock outstanding following this offering is based on 11,457,750 shares of our common stock outstanding as of June 15, 2007, and excludes:

 

   

2,051,749 shares of our common stock reserved for issuance under our stock plans, of which options to purchase 1,800,616 shares of our common stock are outstanding at a weighted average price of $5.06 per share;

 

   

the issuance of up to 598,751 shares of our common stock upon the exercise of outstanding warrants at a weighted average price of $13.87 per share, all of which are currently exercisable; and

 

   

shares potentially issuable to InterMune upon our future achievement of a milestone under our agreements with InterMune, consisting of 358,798 shares of our Series C-2 preferred stock and 358,797 shares of our Series C-3 preferred stock, as well as a warrant exercisable for up to 35,553 shares of our Series C-1 preferred stock.

This number also assumes no exercise of the underwriters’ over-allotment option. If the over-allotment option is exercised in full, we will issue and sell an additional              shares of our common stock.

 


 

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Except as otherwise noted, we have presented the information in this prospectus based on the following assumptions:

 

   

a 1-for-             reverse stock split of our common stock completed immediately prior to the effectiveness of this offering;

 

   

the issuance and sale of              shares of our common stock in the offering at the initial public offering price of $             per share;

 

   

the exchange of all outstanding exchangeable shares of our two Canadian subsidiaries into 3,582,805 shares of common stock of the Company, which exchange shall be effected upon the closing of this offering;

 

   

the automatic conversion of all outstanding shares of our preferred stock, including preferred exchangeable shares of our two Canadian subsidiaries, which shares will be exchanged into shares of our preferred stock immediately prior to this offering, into an aggregate of 11,437,520 shares of our common stock and the conversion of outstanding warrants to purchase 598,751 shares of our common stock upon the closing of this offering;

 

   

no exercise by the underwriters of their over-allotment option to purchase additional shares of our common stock in the offering; and

 

   

the filing of our amended and restated certificate of incorporation with the Secretary of State of the State of Delaware and the adoption of our amended and restated by-laws immediately prior to the closing of the offering.

 

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SUMMARY CONSOLIDATED FINANCIAL INFORMATION

The following tables present a summary of our historical financial information and pro forma net loss per common share. You should read the following summary financial data in conjunction with “Selected consolidated financial data,” “Management’s discussion and analysis of financial condition and results of operations” and our consolidated financial statements and related notes, all included elsewhere in this prospectus. Pro forma basic and diluted net loss per common share is calculated assuming the automatic conversion of all outstanding shares of our convertible preferred stock, redeemable convertible preferred stock and convertible debt as of December 31, 2006 into an aggregate of 383,036 shares of our common stock and as of March 31, 2007 into an aggregate of 11,437,520 shares of our common stock. In 2005, we changed our fiscal year end from May 31 to December 31.

 

     

Year Ended

May 31,

2004

   

Year Ended

May 31,

2005

   

Seven Months
Ended

December 31,

2005

   

Year Ended

December 31,

2006

   

Three Months Ended

March 31,

   

For the Period from

May 20, 1997 (date of

inception) through

March 31,

2007

 
                  2006             2007        
    Restated     Restated     Restated     Restated     (unaudited)     (unaudited)  
   

(in thousands, except share and per share data)

 

Statement of operations data:

             

Operating expenses

             

Research and development

  $ 5,198     $ 4,503     $ 2,319     $ 11,456     $ 2,179     $ 5,439     $ 36,186  

Acquired in-process research and development

    —         —         11,847       —         —         9,500       21,347  

General and administrative

    1,506       1,388       2,108       3,352       561       1,935       13,065  
                                                       

Total operating expenses

    6,704       5,891       16,274       14,808       2,740       16,874       70,598  
                                                       

Other income (expense)

             

Interest income

    125       78       31       280       84       458       1,373  

Interest expense

    (41 )     (211 )     (852 )     (14,968 )     (4,229 )     (2,210 )     (18,434 )

Foreign exchange gain (loss)

    —         —         15       (214 )     (9 )     (64 )     (264 )

Gain on disposal of property and equipment

    —         —         —         —         —         —         47  
                                                       

Other income (expense), net

    84       (133 )     (806 )     (14,902 )     (4,154 )     (1,816 )     (17,278 )
                                                       

Loss before income tax (expense) benefit

    (6,620 )     (6,024 )     (17,080 )     (29,710 )     (6,894 )     (18,690 )     (87,876 )

Income tax (expense) benefit

    776       759       1,491       (431 )     (99 )     (29 )     5,574  
                                                       

Net loss

  $ (5,844 )   $ (5,265 )   $ (15,589 )   $ (30,141 )   $ (6,993 )   $ (18,719 )   $ (82,302 )
                                                       

Net loss per share—basic and diluted

  $ (344.16 )   $ (305.33 )   $ (791.46 )   $ (1,582.84 )   $ (368.89 )   $ (936.41 )  
                                                 

Weighted average number of common shares used in net loss per share—basic and diluted

    20,209       20,216       20,230       20,230       20,230       20,230    

Unaudited

             

Pro forma net loss per share—basic and diluted

        $ (122.86 )     $ (2.23 )  

Shares used in computing pro forma net loss per share—basic and diluted

          298,918         11,457,750    

 

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The pro forma balance sheet data as of March 31, 2007 gives effect to the automatic conversion of all outstanding shares of our convertible preferred stock into an aggregate of 11,437,520 shares of our common stock upon the closing of this offering. The pro forma as adjusted balance sheet data as of March 31, 2007 also gives effect to the sale of              shares of common stock offered by this prospectus at the assumed initial public offering price of $             per share, after deducting underwriting discounts and commissions and estimated offering expenses.

 

As of March 31, 2007

   Actual     Pro forma    

Pro forma

as adjusted

     (unaudited)     (unaudited)      
     (in thousands)

Balance sheet data:

      

Cash, cash equivalents and short-term investments

   $ 58,032     $ 58,032     $             

Working capital

     55,705       55,705    

Total assets

     61,587       61,587    

Note payable

     7,565       7,565    

Deficit accumulated during the development stage

     (82,302 )     (82,302 )  

Total stockholders’ equity

     47,943       47,943    

 

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RISK FACTORS

Investing in our common stock involves a high degree of risk. You should consider carefully the risks described below, together with the other information in this prospectus (including our financial statements and the related notes) before investing in our common stock. If any of the following risks actually occur, our business, operating results or financial condition could be materially adversely affected. This could cause the market price of our common stock to decline, and could cause you to lose all or part of your investment.

Risks Related to our Business

We are dependent on the success of our lead product candidate, oritavancin, and we cannot give any assurance that it will receive regulatory approval, which is necessary before it can be commercialized.

Our near-term prospects are substantially dependent on our ability to submit an NDA on a timely basis for our lead product candidate, oritavancin, obtain FDA approval to market oritavancin and successfully commercialize this product. We currently plan to submit an NDA to the FDA in the first quarter of 2008 seeking approval to commercialize oritavancin for the treatment of cSSSI. We will not be able to commercialize oritavancin prior to obtaining FDA approval. Even if we submit an NDA to the FDA on our currently anticipated timeline, we would not expect to receive FDA approval and be able to commercialize this product for at least twelve months after the date of this offering, at the earliest. We cannot assure you that our timeline for filing an NDA for oritavancin will not be delayed, or that we will be able to obtain FDA approval for this product. If we are not able to commercialize oritavancin for cSSSI or for any other indications, we will not be able to generate product revenues in the foreseeable future, or at all. Oritavancin is the only one of our product candidates for which clinical trials have been conducted, and we do not expect to advance any other product candidates into clinical trials until 2009, if at all.

We have limited experience conducting clinical trials, and no prior experience in submitting an NDA to the FDA seeking regulatory approval to commercialize a drug. The two Phase 3 clinical trials that we intend to use in support of our NDA for oritavancin for cSSSI were conducted by our predecessors in the development of this drug. These two Phase 3 trials were designed and conducted as non-inferiority studies in which oritavancin was compared with vancomycin followed by cephalexin, an approved treatment for patients who have serious gram-positive infections. The goal of a non-inferiority study, such as those conducted with respect to oritavancin, is to show that a product candidate is not less effective than the approved treatment.

It is possible that the FDA may refuse to accept our NDA for substantive review or may conclude after review of our data that our application is insufficient to allow approval of oritavancin. If the FDA does not accept or approve our NDA, it may require that we conduct additional clinical, pre-clinical or manufacturing validation studies and submit that data before it will reconsider our application. Depending on the extent of these or any other FDA required studies, approval of any NDA or application that we submit may be delayed by several years, or may require us to expend more resources than we have available. In addition, increased scrutiny by the United States Congress of the FDA’s approval process may significantly delay or prevent regulatory approval, as well as impose more stringent product labeling and post-marketing testing requirements on pharmaceutical products generally, and particularly in our areas of focus. Any delay in obtaining, or an inability to obtain, regulatory approvals would prevent us from commercializing oritavancin or any of our other product candidates, generating revenues, and achieving and sustaining profitability. It is also possible that additional studies, if performed and completed, may not be considered sufficient by the FDA to approve our application. If any of these outcomes occur, we may be forced to abandon our application for approval of oritavancin, which would materially adversely affect our business and could potentially cause us to cease operations.

 

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We may experience significant delays in the launch of oritavancin for commercialization, which would delay our generation of revenues.

We could experience significant delays in the commercial launch of oritavancin due to many factors, including:

 

   

a delay in the filing of our NDA with the FDA, whether as a result of unforeseen delays in compiling clinical trial data from the Phase 3 trials conducted on oritavancin for inclusion in our NDA or otherwise;

 

   

the FDA’s refusal to accept our NDA, any requirement by the FDA that we conduct additional studies to support our NDA or the denial by the FDA of our NDA submission;

 

   

the receipt of unsatisfactory or unexpected results from the additional toxicology testing that we intend to perform as a result of a request from the FDA on existing oritavancin drug product produced by Abbott Laboratories (or Abbott) and Catalent Pharma Solutions, Inc. (formerly Cardinal Health PTS, LLC) (or Catalent), our current suppliers, which results could cause the FDA to refuse to approve our NDA, require us to conduct additional testing, require changes to our manufacturing process or prohibit us from using existing drug product inventory for the commercial launch of oritavancin;

 

   

any requirement by the FDA that the drug product we use for commercial launch contain a reduced level of impurities, which could potentially render our existing drug product inventory unusable for our planned commercial launch and would require us to expend considerable time and expense to replace that inventory for commercial launch, which may be impossible or cost-prohibitive;

 

   

any issues raised by the FDA in connection with its pre-approval inspections of the manufacturing facilities of our contract manufacturing partners, which may result in the FDA’s refusal to approve oritavancin for commercial sale or may require additional manufacturing validation studies or restrictions on operations, any of which would be costly and time consuming and require further FDA review and approval;

 

   

any delay in commencing and completing further Phase 2 and Phase 3 clinical trials of oritavancin for other indications, including for the treatment of cSSSI with a single, larger dose, or for the treatment of other indications;

 

   

the receipt of unsatisfactory or unexpected results from these further clinical trials, which could cause the FDA to require us to perform additional testing or to deny applications that we intend to submit in the future for additional indications for oritavancin;

 

   

a delay in filing required applications with foreign regulatory authorities and any requirement by a foreign regulatory authority that we conduct further clinical trials in order to qualify our application for approval; and

 

   

our failure to establish a sales and marketing force in the time frame that we anticipate and any failure or delay in getting oritavancin listed on hospital and health management organization formularies.

Any one or a combination of these events could significantly delay, or even prevent, our ability to commercialize oritavancin. If we are not successful in commercializing oritavancin, or if we are significantly delayed in doing so, our business, operating results and financial condition will be materially adversely affected.

Recent FDA and Congressional actions have led to uncertainty as to the standards for obtaining FDA approval of new drugs generally and new antibiotics specifically, and we cannot assure you that the FDA will not either require us to meet new standards in order to obtain approval for commercial sale of oritavancin or require us to demonstrate to the FDA’s satisfaction why trial results under superseded standards are adequate.

In 2006, the FDA, for certain types of antibiotics for certain less serious, typically self-resolving infections, refused to accept successfully completed non-inferiority studies as the basis for approval. Instead, for some

 

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antibiotic products or trials involving comparator antibiotics, the FDA required placebo-controlled trials demonstrating the superiority of a drug candidate to placebo before considering approval. Conducting placebo-controlled trials for antibiotics can be time-consuming, expensive, and difficult to complete. Institutional review boards may not grant approval for placebo-controlled trials because of ethical concerns about denying some participating patients access to any antibiotic therapy during the course of the trial. Even if institutional review board approval is obtained, it may be difficult to enroll patients in placebo-controlled trials, particularly for infections that are serious and, if left untreated, life-threatening, because certain patients would not receive antibiotic therapy. In addition, the FDA has not indicated whether all antibiotics would require placebo- controlled superiority studies for FDA approval. This lack of guidance creates uncertainties about the standards for approval of antibiotics in the United States.

Moreover, recent events, including complications arising from FDA-approved drugs, have raised questions about the safety of marketed drugs and may result in new legislation by the United States Congress and increased caution by the FDA and comparable foreign regulatory authorities in reviewing new drugs based on safety, efficacy or other regulatory approvals. In particular, non-inferiority studies have come under scrutiny from Congress, in part because of a congressional investigation as to the safety of Ketek, an antibiotic approved by the FDA on the basis of non-inferiority studies. Certain key members of Congress have asked the United States Government Accountability Office, an independent, non-partisan arm of Congress, to investigate the FDA’s reliance on non-inferiority studies as a basis for approval. It is possible that members of Congress may draft and introduce, and that Congress may pass, legislation that could significantly change the FDA’s approval process for antibiotics. If this were to happen, the path to regulatory approval for oritavancin might be significantly delayed.

We believe, based on our communications to date with the FDA, that the FDA will not require placebo-controlled studies to support approval of an NDA for oritavancin for cSSSI. In particular, the FDA has acknowledged that clinical trials relying on a non-inferiority trial design, like the two Phase 3 clinical trials conducted by our predecessors on oritavancin for cSSSI, are the appropriate type of trial design for the study of the safety and efficacy of oritavancin for the treatment of a serious and, if left untreated, life-threatening infection like cSSSI. However, though we have not been asked to date to do so, we cannot assure you that the FDA will not require us to perform additional clinical trials to demonstrate the non-inferiority or superiority of oritavancin as compared either to placebo or to previously approved treatments like vancomycin. In addition, we cannot assure you that the FDA will, when reviewing our NDA submission, consider the results of the two Phase 3 clinical trials of oritavancin sufficient.

If we cannot justify to the FDA the 15% non-inferiority margin used in the first Phase 3 study of oritavancin with respect to oritavancin’s benefit over placebo and its non-inferiority to vancomycin and other approved antibiotics, the FDA may not approve oritavancin without an additional Phase 3 study or at all.

The first of the two Phase 3 studies of oritavancin for cSSSI conducted by our predecessors was designed to demonstrate non-inferiority on primary endpoint with a delta, or difference, in cure rate of 15% between oritavancin and the comparator (a combination of vancomycin followed by cephalexin). A 15% delta was appropriate for this non-inferiority trial at the time the FDA reviewed the protocol design of this Phase 3 trial, which commenced in 1999. The results of this first Phase 3 trial demonstrated oritavancin’s efficacy at the lower bound using a 95% confidence interval to be -14.8%, which was within the non-inferiority delta as compared to the control arm. Although the trial results were within the then accepted 15% non-inferiority delta for this particular clinical trial, new International Conference on Harmonization, or ICH, guidelines now request the sponsor to provide a reliable estimate of the placebo-adjusted cure rate of the control treatment (in our case, vancomycin) in a population similar to that enrolled in the trial, before selecting the non-inferiority margin. In pre-NDA meetings, the FDA has noted that a new retrospective justification by us of a 15% non-inferiority margin, based on the new ICH guidelines, will be a critical element in its review of this Phase 3 clinical trial. We are in the process of compiling materials and information in an effort to apply the new ICH guidelines to support

 

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retrospectively the 15% non-inferiority margin. If we are unable to identify sufficient materials and information to justify the 15% non-inferiority margin, or if the FDA does not find the materials and information we submit to be persuasive and sufficient to support approval of an NDA or find our justification for the use of a 15% non-inferiority delta compelling, we may be unable to obtain FDA approval for oritavancin without additional clinical trials or at all. Any requirement of the FDA that we conduct an additional Phase 3 study of oritavancin would entail substantial expense and delay, and we cannot assure you in such a case that oritavancin would ever receive FDA approval.

If we are unable to discover, develop or acquire product candidates that are safe and effective, our business will be adversely affected.

We have never commercialized any of our product candidates. Further, we are uncertain whether any of our product candidates will prove effective and safe in humans or meet applicable regulatory standards. Companies in the biotechnology and pharmaceutical industries, including companies with greater experience in pre-clinical testing and clinical trials than we have, have suffered significant setbacks in advanced clinical trials, even after demonstrating promising results in earlier trials. The risk of failure for all of our product candidates is high. The data supporting our drug discovery and development programs is derived solely from laboratory experiments, pre-clinical studies and clinical studies. Further, we have limited experience conducting clinical trials, and the two Phase 3 clinical trials that we will use in support of the NDA we intend to submit to the FDA later this year for oritavancin for cSSSI were conducted by our predecessors in the development of oritavancin. There can be no assurance that the Phase 3 clinical trials conducted by our predecessors included a sufficiently large population of patients to demonstrate safety and efficacy sufficient for the FDA to approve the dosage levels that will be included in the product label within our NDA submission.

We anticipate performing further clinical trials of oritavancin over the next several years in an effort to establish its efficacy in other indications. Beyond oritavancin, our other compounds remain in the lead identification, lead optimization, pre-clinical testing and early clinical testing stages. It is, therefore, impossible to predict when or if any of our compounds and product candidates will prove effective or safe in humans or will receive regulatory approval.

In addition to internal development, an element of our strategy is to seek to in-license other innovative antibiotic product candidates from third parties. Our success in executing on this strategy depends upon our ability to identify, select and acquire the right product candidates and products on terms that are acceptable to us. Any product candidate we identify, license or acquire may require additional development efforts prior to commercial sale, including extensive clinical testing and approval by the FDA and applicable foreign regulatory authorities.

If we are unable to discover, develop or acquire medicines that are effective and safe in humans, our business will fail.

The development and testing of our product candidates are subject to extensive regulation, which can be costly and time consuming. Any of our product candidates may encounter unanticipated delays or suffer significant setbacks or fail in later clinical studies.

Product candidates that have shown promising results in early pre-clinical or clinical studies may subsequently suffer significant setbacks or fail in later clinical studies. Clinical studies involving our product candidates may reveal that those candidates are ineffective, inferior to existing approved medicines, unacceptably toxic or have other unacceptable side effects. Negative or inconclusive results from or adverse medical events during a clinical trial could cause the clinical trial to be repeated or a program to be terminated, even if other studies or trials relating to the program are successful.

 

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Clinical testing is expensive, can take many years to complete and its outcome is uncertain. Failure can occur at any time during the clinical trial process. Additionally, the time required to obtain approval by the FDA is unpredictable, but typically takes many years following the commencement of clinical trials. If our clinical studies are substantially delayed or fail to prove the safety and effectiveness of our product candidates, we may not receive regulatory approval of any of our product candidates, and our business, operating results and financial condition will be materially harmed.

Further, we must conduct our clinical trials under protocols that are acceptable to regulatory authorities and to the committees responsible for clinical studies at the hospital sites at which these studies are conducted. We may experience delays in preparing protocols or receiving approval for them that may delay either or both of the start and finish of our clinical trials. In addition, we may receive feedback from regulatory authorities or results from earlier stage clinical studies that require modifications or delays in planned later stage clinical trials or that cause a termination or suspension of our drug development efforts. If we were to encounter any of these types of delays or suspensions, our drug development costs would likely increase and the timeline for our receipt of regulatory approvals would likely be delayed.

We may be required to suspend or discontinue clinical trials due to the occurrence of unacceptable side effects or other safety risks that could preclude or delay approval of our product candidates.

Our clinical trials may be suspended at any time for a number of reasons. We may voluntarily suspend or terminate our clinical trials if at any time we believe that they present an unacceptable risk to participants. In addition, regulatory agencies may order the temporary or permanent discontinuation of our clinical trials at any time if they believe that the clinical trials are not being conducted in accordance with applicable regulatory requirements or that they present an unacceptable safety risk to participants.

Many antibiotics produce significant side effects, including severe allergic reaction, decreased blood pressure, suppression of the bone marrow, inflammation, swelling at the site of injection, muscle toxicity, optic and peripheral neuropathies and headaches. In clinical trials performed to date, side effects of oritavancin have included headache, nausea, vomiting, constipation, phlebitis, dizziness, insomnia, diarrhea and histamine reactions such as flushing, wheezing and itching. In addition, future clinical trials could reveal other side effects. The incidence of these or other side effects could cause us to interrupt, delay or halt future clinical trials of our product candidates and could result in the FDA or other regulatory authorities stopping further development of or denying approval of our product candidates for any or all targeted indications. Even if we believe our product candidates are safe, our data is subject to review by the FDA and comparable foreign regulatory authorities, which may disagree with our conclusions. Moreover, though we have clinical trial insurance, we could be subject to significant liability if any volunteer or patient suffers, or appears to suffer, adverse health effects as a result of participating in one of our clinical trials.

In 2004, InterMune, then the developer of oritavancin, requested a voluntary, self-imposed clinical hold on oritavancin prior to completion of two Phase 1 studies (OCSI-007 and OCSI-008) that were performed to evaluate drug-drug interaction and QT interval prolongation. InterMune requested this self-imposed clinical hold in part due to the observance of phlebitis at the infusion site judged to be unexpectedly greater in incidence and severity than anticipated. We have, since our acquisition of the rights to oritavancin from InterMune in December 2005, reexamined the data from all of the clinical trials with oritavancin and determined that the incidence of phlebitis in the clinical trials of oritavancin for cSSSI was not substantially higher than found with treatment with vancomycin or other glycopeptides. Further, we submitted our assessment of this data to the FDA and, at a January 2007 pre-NDA meeting, the FDA accepted our assessment and agreed to lift the voluntary clinical hold on oritavancin. Although we believe that we have satisfactorily resolved this safety concern, we cannot assure you that this historic safety concern or any other safety concerns will not result in significant delays in obtaining regulatory approval of our NDA or more stringent product labeling requirements for the cSSSI indication.

 

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The regulatory approval process for our product candidates is complex and costly. If oritavancin or the other product candidates that we develop are not approved by regulatory agencies, including the FDA, we will be unable to commercialize them.

Before we can launch our product candidates for commercial distribution, we must provide the FDA and similar foreign regulatory authorities with data from pre-clinical and clinical studies that demonstrates that our product candidates are safe and effective for a defined indication. Our product candidates may face delays in receiving regulatory approval or may fail to receive regulatory approval at all for many reasons, including the following:

 

   

approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change;

 

   

we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe and effective for a particular indication;

 

   

the results of clinical trials may not meet the level of statistical significance required by the FDA or other regulatory authorities for approval;

 

   

the FDA or other regulatory authorities may disagree with the design of our clinical trials;

 

   

we may be unable to demonstrate that a product candidate’s benefits outweigh its risks or that it presents an advantage over existing therapies, or over placebo in any indications for which the FDA requires a placebo-controlled trial;

 

   

the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from pre-clinical studies or clinical trials, including our assessment that the incidence of injection-site phlebitis in healthy volunteers in the clinical trials performed by our predecessors on oritavancin for cSSSI (which trials involved a higher dose of oritavancin than the one we will include in our initial NDA submission for oritavancin) was not substantially higher than shown for approved treatment protocols like vancomycin and other glycopeptides;

 

   

the data collected from clinical trials of our product candidates may not be sufficient to support the submission of an NDA or to obtain regulatory approval in the United States or elsewhere, or may only be sufficient under subsequently superseded regulatory requirements;

 

   

we may encounter difficulty in maintaining contact with patients after treatment, resulting in incomplete clinical trial data;

 

   

we may face delays in patient enrollment and variability in the number and types of patients available for clinical studies;

 

   

clinical trials of our product candidates may result in adverse events, safety issues or side effects relating to our product candidates or their formulation into medicines; and

 

   

the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of manufacturers with which we contract for clinical and commercial supplies.

We will not obtain regulatory approval for a product candidate in the United States unless and until the FDA approves an NDA. In order to market our medicines outside of the United States, we must obtain separate regulatory approvals in each country unless, in the case of the EU, we follow the centralized approval process. The approval procedure varies among countries and can involve additional testing. Further, the time required to obtain approval from foreign regulatory authorities may differ from that required to obtain FDA approval. Approval by the FDA does not ensure approval by regulatory authorities in other countries, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other foreign countries or by the FDA. Satisfaction of these and other regulatory requirements is costly, time consuming, uncertain and subject to unanticipated delays. We have not yet submitted an NDA to the FDA or made a comparable submission in any foreign country for any of our product candidates, including oritavancin.

 

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The FDA or comparable foreign regulatory authorities might decide that our data is insufficient for approval and require additional clinical trials or other studies. Additionally, recent events have raised questions about the safety of marketed drugs and may result in increased cautiousness by the FDA and/or comparable foreign regulatory authorities in reviewing new drugs based on safety, efficacy or other regulatory considerations. Further, the FDA and comparable foreign regulatory authorities may decelerate regulatory approvals for new drug candidates and impose more stringent product labeling requirements in an effort to ensure that approved drugs are safe and efficacious. Any delay in obtaining, or any inability to obtain, applicable regulatory approvals would prevent us from commercializing our product candidates. Further, even if we do receive regulatory approval to market a commercial product, that approval may be subject to limitations on the indicated uses for the approved drug product. It is possible that none of our existing product candidates or any product candidates we may seek to develop in the future will ever obtain the necessary regulatory approvals for commercialization.

Oritavancin may not be accepted by physicians, patients, third party payors, or the medical community in general.

Even if oritavancin is approved by the relevant regulatory agencies, the commercial success of oritavancin will depend upon its acceptance by physicians, patients, third party payors and the medical community in general. If approved, oritavancin will compete with vancomycin, a relatively inexpensive generic drug that is manufactured by a variety of companies, a number of existing antibiotics manufactured and marketed by major pharmaceutical companies and others, including linezolid (marketed by Pfizer as Zyvox) and daptomycin (marketed by Cubist as Cubicin), and potentially new antibiotics that are not yet on the market. Even if the medical community accepts that oritavancin is safe and efficacious for its approved indications, physicians may not immediately be receptive to the use of oritavancin or may be slow to adopt it as an accepted treatment for gram-positive infections. In the United States and elsewhere, sales of pharmaceutical products depend in significant part on the availability of coverage and reimbursement to providers and the consumer from third-party payors, such as government and private insurance plans. These third-party payors are increasingly challenging and negotiating the prices charged for medical products and services based on their degree of value to the patient. If not added to hospital and managed care organization formularies, oritavancin will not be available for prescription by treating physicians.

If we are unable to demonstrate to physicians that, based on experience, clinical data, side-effect profiles and other factors, oritavancin is preferable to vancomycin and other existing or subsequently-developed anti-infective drugs, we may never generate meaningful revenue from oritavancin. The degree of market acceptance of oritavancin depends on a number of factors, including, but not limited to:

 

   

the demonstrated clinical efficacy and safety of oritavancin;

 

   

our ability to educate the medical community about the safety and effectiveness of oritavancin;

 

   

the cost of treatment using oritavancin in relation to alternative treatments, including vancomycin and other generic antibiotics;

 

   

acceptance by physicians and patients of oritavancin as a safe and effective treatment;

 

   

the extent to which oritavancin is approved for inclusion on formularies of hospitals and managed care organizations;

 

   

the reimbursement policies of government and third party payors;

 

   

the perceived advantages of oritavancin over alternative treatments, including its potency, treatment period and side effects as compared to other alternative treatments;

 

   

the clinical indications for which oritavancin is approved and whether oritavancin is effective against a broad range of gram-postitive infections or only certain ones;

 

   

the extent to which bacteria develop resistance to oritavancin, thereby limiting its efficacy in treating or managing infections;

 

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whether oritavancin is designated under physician treatment guidelines as a first-line therapy or as a second- or third-line therapy for particular infections;

 

   

relative convenience and ease of administration; and

 

   

prevalence and severity of side effects.

We have incurred operating losses in each year since our inception and expect to continue to incur substantial losses for the foreseeable future.

We have been engaged in discovering and developing compounds and product candidates since May 1997. We only acquired worldwide rights to oritavancin from InterMune in December 2005. To date, we have not generated any product sales revenue from oritavancin or any drug product candidate, and we may never generate revenue from selling pharmaceutical products. Further, even if we are able to commercialize oritavancin or any other product candidate, there can be no assurance that we will ever achieve profitability. As of March 31, 2007, we had a deficit accumulated during the development stage of approximately $82.3 million, restated.

Assuming we obtain FDA approval, we expect that our expenses will increase as we prepare for the commercial launch of oritavancin and as we conduct further clinical trials on oritavancin for other indications. We also expect that our research and development expenses will continue to increase as we continue to initiate new discovery programs and expand our development programs. As a result, we expect to continue to incur substantial losses for the foreseeable future, and these losses may be increasing. We are uncertain when or if we will be able to achieve or sustain profitability. Failure to become and remain profitable would adversely affect the price of our common stock and our ability to raise capital and continue operations.

If we are unable to generate revenues from any product candidates, including oritavancin, or if we are unable to cost-effectively acquire other drug candidates or drug products, our ability to create long-term shareholder value may be limited.

We have no drug products that have been approved by the FDA. Our product candidate closest to possible commercialization is oritavancin, for which we have not yet filed an NDA and for which we must still seek and receive regulatory approval prior to commercial launch. We do not have any product candidates that will generate revenues in the near term. We note that most drug candidates never make it to the clinical development stage and even those that do make it into clinical development have only a small chance of gaining regulatory approval and becoming a drug product. If we are unable to commercialize any of our current or future drug candidates, including oritavancin, or to acquire any marketable drug products, our ability to create long-term shareholder value will be limited.

In the future, we may seek out opportunities to partner with other companies to acquire rights to other drug candidates or drug products, but there is no guarantee that we will be successful in these efforts. The market to acquire rights to promising drug candidates and drug products is highly competitive, and we would be competing with companies that have significantly more resources and experience than we have. In addition, proposing, negotiating, completing and integrating an economically viable drug product acquisition or license is a lengthy and complex process. We may not be able to acquire or license the rights to additional product candidates and approved products on terms that we find acceptable, or at all.

We face significant competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete effectively.

The biotechnology and pharmaceutical industries are intensely competitive. We have competitors both in the United States and internationally, including major multinational pharmaceutical companies, biotechnology companies and universities and other research institutions. Many of our competitors have greater financial and

 

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other resources, such as larger research and development staff and more experienced marketing and manufacturing organizations. Our competitors may succeed in developing, acquiring or licensing on an exclusive basis technologies and drug products that are more effective or less costly than oritavancin or any drug candidate that we are currently developing or that we may develop, which could render our technology obsolete and noncompetitive.

The competition in the market for therapeutic products that address infectious diseases is intense. Oritavancin faces competition in the United States from commercially available drugs such as vancomycin, marketed generically by Abbott, Shionogi & Co., Ltd., and others; daptomycin, marketed by Cubist Pharmaceuticals, Inc. as Cubicin; and linezolid, marketed by Pfizer, Inc. as Zyvox. In particular, vancomycin has been a widely used and well known antibiotic for over 40 years and is sold in a relatively inexpensive generic form. Vancomycin, daptomycin and linezolid are all approved treatments for serious gram positive infections such as cSSSI. Further, daptomycin is an approved treatment for bacteremia, linezolid is an approved treatment for nosocomial pneumonia and vancomycin is an approved treatment for both bacteremia and pneumonia.

In addition, Pfizer is seeking FDA approval to market dalbavancin (under the name Zeven ® ) in the United States, which, according to filings made by Pfizer with the Securities and Exchange Commission, could occur during 2007, and, according to filings made by Theravance with the Securities and Exchange Commission, Theravance is seeking FDA approval to market telavancin in the United States and submitted an NDA for telavancin in 2006. Other drug candidates in development include ceftobiprole (developed by Johnson & Johnson) and iclaprim (developed by Arpida Ltd.), which, if approved, would compete in the intravenous antibiotic market and would target indications such as cSSSI. In addition, oritavancin may face competition from drug candidates currently in clinical development and drug candidates that could receive regulatory approval before oritavancin in countries outside the United States and the European Union.

Our ability to compete successfully will depend largely on our ability to leverage our experience in drug discovery and development to:

 

   

discover and develop medicines that are superior to other products in the market;

 

   

attract qualified scientific, product development and commercial personnel;

 

   

obtain patent and/or other proprietary protection for our medicines and technologies;

 

   

obtain required regulatory approvals; and

 

   

successfully collaborate with pharmaceutical companies in the discovery, development and commercialization of new medicines.

Any new medicine that competes with a generic market leading medicine must demonstrate compelling advantages in efficacy, convenience, tolerability and/or safety in order to overcome severe price competition and be commercially successful. If approved, oritavancin must demonstrate these advantages, as it will compete with vancomycin, a relatively inexpensive generic drug that is manufactured by a number of companies, and a number of existing antibiotics marketed by major pharmaceutical companies. We will not achieve our business plan if the acceptance of oritavancin is inhibited by price competition or the reluctance of physicians to switch from existing drug products to oritavancin or if physicians switch to other new drug products, or choose to reserve oritavancin for use in limited circumstances. The inability to compete with existing drug products or subsequently introduced drug products would have a material adverse impact on our operating results.

Established pharmaceutical companies may invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds that could make our product candidates obsolete. Accordingly, our competitors may succeed in obtaining patent protection, receiving FDA approval or discovering, developing and commercializing medicines before we do. We are also aware of other companies that may currently be engaged in the discovery of medicines that will compete with the product candidates that we are developing.

 

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Reimbursement may not be available for oritavancin or our other product candidates, which could make it difficult for us to sell our products profitably.

Market acceptance and sales of oritavancin or our product candidates will depend on reimbursement policies and may be affected by future health care reform measures. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which drugs they will pay for and establish reimbursement levels. We cannot be sure that reimbursement will be available for oritavancin or any of our other product candidates. Also, we cannot be sure that reimbursement amounts will not reduce the demand for, or the price of, our products. If reimbursement is not available or is available only to limited levels, we may not be able successfully to commercialize oritavancin or any of our other products.

In both the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory changes to the health care system that could impact our ability to sell our products profitably. In particular, the Medicare Modernization Act of 2003 added an outpatient prescription drug benefit to Medicare, which became effective on January 1, 2006. Drug benefits under this provision are administered through private plans that negotiate price concessions from pharmaceutical manufacturers. We cannot be certain that oritavancin will successfully be placed on the list of drugs covered by particular health plans, plan formularies, nor can we predict the negotiated price for oritavancin, which will be determined by market factors. With respect to Medicaid, the Deficit Reduction Act of 2005 made several changes to the way pharmacies are reimbursed under Medicaid, most of which went into effect on January 1, 2007, which changes could lead to reduced drug prices. Many states have also created preferred drug lists and include drugs on those lists only when the manufacturers agree to pay a supplemental rebate. If oritavancin is not included on these preferred drug lists, physicians may not be inclined to prescribe it to their Medicaid patients.

As a result of legislative proposals and the trend towards managed health care in the United States, third-party payors are increasingly attempting to contain health care costs by limiting both coverage and the level of reimbursement of new drugs. They may also refuse to provide any coverage of uses of approved products for medical indications other than those for which the FDA has granted market approvals. As a result, significant uncertainty exists as to whether and how much third-party payors will reimburse patients for their use of newly-approved drugs, which in turn will put pressure on the pricing of drugs. The availability of numerous generic antibiotics at lower prices than branded antibiotics, such as oritavancin, if it were approved for commercial introduction, may also substantially reduce the likelihood of reimbursement for oritavancin. We expect to experience pricing pressures in connection with the sale of our products due to the trend toward managed health care, the increasing influence of health maintenance organizations and additional legislative proposals.

Our ability to pursue the development and commercialization of oritavancin depends upon the continuation of our license from Lilly.

Our license agreement with Lilly provides us with a worldwide exclusive license to develop and sell oritavancin in fields relating to infectious diseases. Pursuant to the license agreement, we are required to make certain milestone and royalty payments to Lilly. The license rights to oritavancin granted to us could revert to Lilly if we do not continue to use commercially reasonable efforts to develop and commercialize an oritavancin drug product or if we otherwise materially breach the agreement. In addition, either we or Lilly may terminate the license agreement upon the other party’s insolvency or uncured material breach of the agreement. If our license agreement with Lilly were terminated, we would lose our rights to develop and commercialize oritavancin, which would materially and adversely affect our business, results of operations and future prospects.

Even if our product candidates receive regulatory approval, commercialization of these products may be adversely affected by regulatory actions.

Even if we receive regulatory approval, this approval may include limitations on the indicated uses for which we can market our medicines. Further, if we obtain regulatory approval, a marketed medicine and its

 

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manufacturer are subject to continual review, including review and approval of the manufacturing facilities. Discovery of previously unknown problems with a medicine may result in restrictions on its permissible uses, or on the manufacturer, including withdrawal of the medicine from the market. The FDA and similar foreign regulatory bodies may also implement new standards or change their interpretation and enforcement of existing standards and requirements for the manufacture, packaging or testing of products at any time. If we are unable to comply, we may be subject to regulatory or civil actions or penalties that could significantly and adversely affect our business. Any failure to maintain regulatory approval will limit our ability to commercialize our product candidates, which would materially and adversely affect our business, operating results and financial condition.

We rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates.

We have agreements with third-party contract research organizations to provide monitors for and to manage data for our ongoing clinical programs. We rely heavily on these parties for execution of our pre-clinical and clinical studies, and control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol. We and our contract research organizations are required to comply with current good clinical practices, which are regulations and guidelines enforced by the FDA for all of our products in clinical development. The FDA enforces these good clinical practices regulations through periodic inspections of trial sponsors, principal investigators and trial sites. If we or our contract research organizations fail to comply with applicable good clinical practices regulations, the clinical data generated in our clinical trials may be deemed unreliable and the FDA may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that, upon inspection, the FDA will determine that any of our clinical trials comply with good clinical practices regulations. In addition, our clinical trials must be conducted with product produced under good manufacturing practices regulations, and will require a large number of test subjects. Our failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process.

Our contract research organizations have the right to terminate their agreements with us in the event of an uncured material breach. In addition, some of our contract research organizations have an ability to terminate their respective agreements with us if it can be reasonably demonstrated that the safety of the subjects participating in our clinical trials warrants such termination, if we make a general assignment for the benefit of our creditors or if we are liquidated.

If any of our relationships with these third-party contract research organizations terminate, we may not be able to enter into arrangements with alternative contract research organizations. If contract research organizations do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates. As a result, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed.

We have recently hired additional contract research organizations to obtain additional resources and expertise to accelerate our progress with regard to on-going clinical programs and the synthesis of clinical trial data for submission with our NDA for oritavancin. Switching or adding additional contract research organizations involves substantial cost and requires extensive management time and focus. In addition, there is a natural transition period when a new contract research organization commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines. Though we carefully manage our relationships with our contract research organizations, there can be no assurance that we will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our operating results, financial condition or future prospects.

 

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We will be completely dependent on third parties to manufacture oritavancin, and our commercialization of oritavancin could be stopped, delayed or made less profitable if those third parties fail to provide us with sufficient quantities of oritavancin or fail to do so at acceptable quality levels or prices.

We do not have the capability to manufacture our own oritavancin active pharmaceutical ingredient (or API). As a result, we have entered into a manufacturing and supply agreement with Abbott to manufacture and supply us with bulk oritavancin API for clinical and commercial purposes. Abbott is our sole provider of our supply of oritavancin API. Pursuant to our agreement with Abbott, Abbott currently stores some oritavancin API at its facilities in Illinois and the FDA has agreed to consider the use by us of oritavancin API produced by Abbott, upon regulatory approval, for commercial launch. It is possible, however, that if and when we receive regulatory approval to market and sell oritavancin, our current supply of oritavancin API may have exceeded its useful life and no longer be appropriate for commercial sale.

In addition, we do not have the capability to package oritavancin finished drug product for distribution to hospitals and other customers. Consequently, we have entered into an agreement with Catalent to supply us with finished product, to be packaged 100 milligrams in 20 cc vials. Prior to commercial launch, we intend to enter into a similar agreement with an alternate fill/finish drug product supplier for oritavancin so that we can ensure proper supply chain management once we are authorized to make commercial sales of oritavancin. Once finalized, we expect that the selected alternate supplier will provide us with finished drug product, also packaged 100 milligrams in a 20 cc vial. If we receive marketing approval from the FDA, we intend to sell drug product finished and packaged by either Catalent or this alternate supplier.

We have entered into long-term agreements with each of Abbott and Catalent. In the case of the agreement with Abbott, either party to this agreement may terminate the agreement with at least two years advance notice if the terminating party determines in good faith that the clinical development and/or commercialization of oritavancin of the bulk drug substance, before or after the first commercial sale made by us, is not technically or commercially feasible or if it is not economically justifiable. After the initial term of this agreement, which extends until December 31, 2014, the agreement automatically renews for successive two year terms unless terminated by either party with at least twelve months’ notice. If we change the specifications for the bulk drug substance Abbott is to produce, or the FDA or another regulatory body requires us to change the manufacturing specification for the bulk drug substance, and that change would increase Abbott’s manufacturing costs, we must reach an agreement with Abbott about how to allocate the costs associated with the change. If we cannot reach agreement, Abbott may refuse to implement the change, or may terminate the agreement. Further, Abbott may terminate this agreement if the FDA has not approved an NDA prior to January 1, 2010. Finally, either we or Abbott may terminate this agreement on 60 days’ written notice in the event of insolvency of or uncured material breach by the other party.

Our agreement with Catalent provides for an initial three year term continuing until March 27, 2010. Either party may terminate this agreement on 60 days’ written notice in the event of an uncured material breach. In addition, Catalent may suspend production under this agreement until any outstanding payments are brought current. Finally, either party may terminate this agreement upon the other party’s insolvency. We have not yet entered into a long-term agreement with any alternate fill/finish suppliers, but we intend to do so prior to commercial launch of oritavancin in order to ensure that we maintain adequate supplies of finished drug product.

If, for any reason, these third parties are unable or unwilling to perform, we may not be able to terminate our agreements with them, and we may not be able to locate alternative manufacturers or formulators or enter into favorable agreements with them. If Catalent or any alternate supplier of finished drug product, or in particular, Abbott, experiences any significant difficulties in its respective manufacturing processes for oritavancin API or finished product, we could experience significant interruptions in the supply of oritavancin. We note that in connection with the production of a series of three validation lots, one of the manufacturing lots recently failed to meet the required specifications such that it had to be reproduced. Were we to encounter manufacturing issues such as this on a larger scale in the future, our ability to produce a sufficient supply of oritavancin might be negatively affected. Our inability to coordinate the efforts of our third party manufacturing partners, or the lack

 

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of capacity available at our third party manufacturing partners, could impair our ability to supply oritavancin at required levels. Because of the significant regulatory requirements that we would need to satisfy in order to qualify a new bulk or finished product supplier, if we face these or other difficulties with our current suppliers, we could experience significant interruptions in the supply of oritavancin if we decided to transfer the manufacture of oritavancin to one or more alternative suppliers in an effort to deal with the difficulties.

We cannot guarantee that Abbott, Catalent or alternative manufacturers will be able to reduce the costs of commercial scale manufacturing of oritavancin over time. If the manufacturing costs of oritavancin remain at current levels, these costs may significantly impact our operating results. In order to reduce costs, we may need to develop and implement process improvements. However, in order to do so, we will need, from time to time, to notify or make submissions with regulatory authorities, and the improvements may be subject to approval by such regulatory authorities. We cannot be sure that we will receive these necessary approvals or that these approvals will be granted in a timely fashion. We also cannot guarantee that we will be able to enhance and optimize output in our commercial manufacturing process. If we cannot enhance and optimize output, we may not be able to reduce our costs over time.

We believe we have sufficient quantities of manufactured drug substance and have contracted with Catalent to formulate drug product to complete all of the currently planned clinical studies of oritavancin. Further, we plan to have Abbott, Catalent and any alternate suppliers later identified manufacture and package additional bulk drug substance and finished drug product in connection with commercial launch in the event oritavancin is approved for sale by regulatory authorities. If we are unable to do so in a timely manner, the commercial introduction of oritavancin, if approved by the FDA, would be adversely affected.

If the FDA does not approve the manufacturing facilities of Abbott, Catalent or any later identified manufacturing partners, we may be unable to develop or commercialize oritavancin.

We rely on Abbott and Catalent to manufacture bulk oritavancin API and finished drug product, respectively, and currently have no plans to develop our own manufacturing facility. In addition, we expect to add an alternate fill/finish provider prior to commercial launch of oritavancin. The facilities used by our contract manufacturers to manufacture our product candidates must be approved by the FDA, which inspections will be completed after we submit our NDA to the FDA. We do not control the manufacturing process of oritavancin and are completely dependent on our contract manufacturing partners—currently, Abbott and Catalent—for compliance with the FDA’s requirements for manufacture of finished oritavancin drug product. If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the FDA’s strict regulatory requirements, they will not be able to secure FDA approval for the manufacturing facilities. If the FDA does not approve these facilities for the manufacture of oritavancin, we may need to find alternative manufacturing facilities, which would result in significant delays of up to several years in obtaining approval for and manufacturing oritavancin.

In addition, our contract manufacturers will be subject to ongoing periodic unannounced inspections by the FDA and corresponding state and foreign agencies for compliance with current Good Manufacturing Practices, or cGMPs, and similar regulatory requirements. These cGMP regulations cover all aspects of the manufacturing, testing, quality control and record keeping relating to our product candidates. We do not have control over our contract manufacturers’ compliance with these regulations and standards. Failure by any of our contract manufacturers to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, failure to grant approval to market our product candidates, delays, suspensions or withdrawals of approvals, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect our business. In addition, we have no control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. Failure by our contract manufacturers to comply with or maintain any of these standards could adversely affect our ability to develop, obtain regulatory approval for or market our product candidates.

 

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In order to satisfy regulatory authorities, we may need to reformulate the way in which our oritavancin API is created to remove animal source product.

Presently, our oritavancin API is manufactured using animal source product—namely porcine source product. Certain non-US regulatory authorities have historically objected to the use of animal source product—particularly bovine source product—in manufactured drug product. As a result and in order to best position oritavancin for approval in foreign jurisdictions, we have entered into an agreement with Abbott whereby we, along with Abbott, are seeking to develop a manufacturing process for oritavancin API that does not rely on the use of any animal source product.

Although we believe that we can develop a manufacturing process for oritavancin API that does not rely on the use of animal source product, there can be no assurance that we, along with Abbott, will be successful in this endeavor. If we are unable to remove animal source product from the manufacturing process for oritavancin API, it is possible that we will be unable to receive regulatory authority for oritavancin in certain foreign jurisdictions, which would likely have a negative impact on our ability to achieve our business objectives.

We may encounter delays in filling customer orders or incur substantial losses if our supply of bulk and finished drug product, which are produced and packaged for us by third party manufacturers, is interrupted.

Once Abbott has completed production of oritavancin bulk drug product at its facilities in Illinois, the product is shipped to Catalent’s facilities in Arizona for processing, packaging and labeling as final drug product. These shipments are of significant value and, while in transit, could be lost or damaged. Moreover, at any time after being shipped, our oritavancin API or finished drug product could be lost or damaged as it is stored with Catalent, our current finished product manufacturer, or, additionally, in the future, when it is stored at the facilities of any alternate fill/finish supplier. Depending on when in this process the API or finished drug product is lost or damaged, we may have limited recourse for recovery manufacturers or insurers. As a result, our financial performance could be impacted by any such loss of or damage to our oritavancin API.

We also may experience interruption or significant delay in the supply of oritavancin API or finished drug product due to natural disasters, acts of war or terrorism, shipping embargoes, labor unrest or political instability. In any such event, the supply of oritavancin API stored at Abbott and the oritavancin finished drug product stored with Catalent or any alternate fill/finish supplier could also be impacted. We may also be subject to financial risk from volatile fuel costs associated with shipping oritavancin API or finished drug product within the United States and, once we have received necessary foreign approvals, to our international distribution partners for packaging, labeling and distribution.

If we fail to obtain the capital necessary to fund our operations, we may be unable to develop our product candidates and we could be forced to share our rights to commercialize our product candidates with third parties on terms that may not be favorable to us.

We need large amounts of capital to support our research and development efforts. If we are unable to secure capital to fund our operations, we will not be able to continue our discovery and development efforts and we might have to enter into strategic collaborations that could require us to share commercial rights to our products and product candidates with third parties in ways that we currently do not intend. Based on our current operating plans, and after giving effect to the receipt of the net proceeds of this offering, we believe that our cash and cash equivalents and marketable securities will be sufficient to meet our anticipated operating needs into 2009. Depending on the status of regulatory approval or, if approved, commercialization of oritavancin, as well as the progress we make in selling that product candidate, we may require additional capital to fund operating needs thereafter.

Further, we are party to a license agreement with Lilly pursuant to which we are obligated to make certain cash milestone payments to Lilly upon the receipt of certain regulatory approvals of our oritavancin product. In

 

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addition, we are required to make certain cash royalty payments upon our achievement of target levels of commercial sales of our oritavancin product. We are also obligated to make a future cash milestone payment to InterMune upon our receipt from the FDA of all approvals necessary for the commercial launch of oritavancin. Though we believe that these royalty rates and milestone payments are reasonable in light of our business plan, we will require large amounts of capital to satisfy these obligations.

We may also need to raise additional funds sooner if we choose to expand more rapidly than we presently anticipate. To raise additional funds, we may seek to sell additional equity or debt securities, or both, or incur other indebtedness. The sale of additional equity or debt securities, if convertible, could result in the issuance of additional shares of our capital stock and could result in dilution to our stockholders. The incurrence of indebtedness would result in increased fixed payment obligations and could also result in certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. We cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we will be prevented from pursuing research and development efforts. This could harm our business, operating results and financial condition and cause the price of our common stock to fall.

We currently have no sales organization. If we are unable to establish satisfactory sales and marketing capabilities, we may not succeed in commercializing oritavancin.

At present, we have no sales personnel and a limited number of marketing personnel. In anticipation of receiving FDA approval for the commercial launch of oritavancin, we anticipate beginning to hire additional sales and marketing personnel to establish our own sales and marketing capabilities in the United States in time for our anticipated commercial launch of oritavancin. We plan to add our first sales representatives in the first quarter of 2008. Therefore, at the time of our anticipated commercial launch of oritavancin, assuming regulatory approval of the drug by the FDA, our sales and marketing team will have worked together for only a limited period of time. We cannot guarantee that we will be successful in marketing oritavancin in the United States.

We may not be able to establish a direct sales force in a cost effective manner or realize a positive return on this investment. In addition, we will have to compete with other pharmaceutical and biotechnology companies to recruit, hire, train and retain sales and marketing personnel. Factors that may inhibit our efforts to commercialize our products without strategic partners or licensees include:

 

   

our inability to recruit and retain adequate numbers of effective sales and marketing personnel;

 

   

the inability of sales personnel to obtain access to or persuade adequate numbers of physicians to prescribe our products;

 

   

the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and

 

   

unforeseen costs and expenses associated with creating an independent sales and marketing organization.

If appropriate regulatory approvals are obtained, we intend to commercialize oritavancin and our other product candidates in international markets through collaboration arrangements with third parties. We have not yet entered into any agreements related to the marketing of oritavancin or any of our other product candidates in international markets and we may not be able to enter into any arrangements with respect to international collaborations on favorable terms or at all. In addition, these arrangements could result in lower levels of income to us than if we marketed our product candidates entirely on our own. If we are unable to enter into appropriate marketing arrangements for our product candidates in international markets, we may not be able to develop an effective international sales force to successfully commercialize oritavancin and our other product candidates in

 

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international markets. If we fail to enter into marketing arrangements for our products and are unable to develop an effective international sales force, our ability to generate revenue would be limited as a significant portion of the market opportunity for oritavancin and our other product candidates is likely to be in international markets.

If we are not successful in recruiting sales and marketing personnel or in building a sales and marketing infrastructure or if we do not successfully enter into appropriate collaboration arrangements with third parties, we will have difficulty commercializing oritavancin and our other product candidates, which would adversely affect our business, operating results and financial condition.

A variety of risks associated with our international business relationships could materially adversely affect our business.

If approved for commercialization, we expect oritavancin to be marketed worldwide. Consequently, we expect that we will be subject to additional risks related to operating in foreign countries including:

 

   

differing regulatory requirements for drug approvals in foreign countries;

 

   

the potential for so-called parallel importing, which is what happens when a local seller, faced with high or higher local prices, opts to import goods from a foreign market (with low or lower prices) rather than buying them locally;

 

   

unexpected changes in tariffs, trade barriers and regulatory requirements;

 

   

economic weakness, including inflation, or political instability in particular foreign economies and markets;

 

   

compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;

 

   

foreign taxes, including withholding of payroll taxes;

 

   

foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country;

 

   

workforce uncertainty in countries where labor unrest is more common than in the United States;

 

   

production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and

 

   

business interruptions resulting from geo-political actions, including war and terrorism.

These and other risks associated with our international operations may materially adversely affect our ability to attain or maintain profitable operations.

In order to establish our sales and marketing infrastructure, we will need to grow the size of our organization, and we may experience difficulties in managing this growth.

As of June 15, 2007, we employed 77 employees. As our development and commercialization plans and strategies develop, we expect to need to expand the size of our employee base for managerial, operational, sales, marketing, financial and other resources. Future growth would impose significant added responsibilities on members of management, including the need to identify, recruit, maintain, motivate and integrate additional employees. Also, our management may have to divert a disproportionate amount of its attention away from our day-to-day activities and devote a substantial amount of time to managing these growth activities. Our future financial performance and our ability to commercialize oritavancin and our other product candidates and compete effectively will depend, in part, on our ability to effectively manage any future growth.

 

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If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.

Our ability to compete in the highly competitive biotechnology and pharmaceuticals industries depends in large part upon our ability to attract and retain highly qualified managerial, scientific and medical personnel. We are highly dependent on our management, scientific and medical personnel. In order to induce valuable employees to remain at Targanta, we have provided options that vest over time. The value to employees of options that vest over time is significantly affected by movements in our stock price that we cannot control and may at any time be insufficient to counteract more lucrative offers from other companies.

Our scientific team has expertise in many different aspects of drug discovery and development. We conduct our operations at our facilities in Cambridge, Massachusetts, Indianapolis, Indiana and Montreal, Québec, Canada. These areas are headquarters to many other biopharmaceutical companies and many academic and research institutions and, as a result, there is currently a shortage of experienced scientists, which is likely to continue. Competition for skilled personnel in our market is very intense and competition for experienced scientists may limit our ability to hire and retain highly qualified personnel on acceptable terms.

Despite our efforts to retain valuable employees, members of our management, scientific and medical teams may terminate their employment with us on short notice. While we have employment agreements with certain of our employees, these employment arrangements provide for at-will employment, which means that any of our employees could leave our employment at any time, with or without notice. The loss of the services of any of our executive officers or other key employees could potentially harm our business, operating results or financial condition. Our success also depends on our ability to continue to attract, retain and motivate highly skilled junior, mid-level, and senior managers as well as junior, mid-level, and senior scientific and medical personnel.

Other biotechnology and pharmaceutical companies with which we compete for qualified personnel have greater financial and other resources, different risk profiles, and a longer history in the industry than we do. They also may provide more diverse opportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than what we have to offer. If we are unable to continue to attract and retain high quality personnel, the rate and success at which we can discover, develop and commercialize drug candidates would be limited.

We may acquire additional businesses or form strategic alliances in the future, and we may not realize the benefits of such acquisitions.

We may acquire additional businesses or products, form strategic alliances or create joint ventures with third parties that we believe will complement or augment our existing business. If we acquire businesses with promising markets or technologies, we may not be able to realize the benefit of acquiring such businesses if we are unable to successfully integrate them with our existing operations and company culture. We may have difficulty in developing, manufacturing and marketing the products of a newly acquired company that enhances the performance of our combined businesses or product lines to realize value from expected synergies. We cannot assure that, following an acquisition, we will achieve the revenues or specific net income that justifies the acquisition.

Risks Related to Legal Uncertainty

If our efforts to protect the proprietary nature of the intellectual property related to our technologies are not adequate, we may not be able to compete effectively in our market.

We rely upon a combination of patents, trade secret protection and confidentiality agreements to protect the intellectual property related to our technologies. Any involuntary disclosure to or misappropriation by third

 

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parties of our confidential proprietary information could enable competitors to quickly duplicate or surpass our technological achievements, thus eroding our competitive position in our market. The strength of patents in the biotechnology and pharmaceutical field involves complex legal and scientific questions and can be uncertain.

As of March 31, 2007, through our license agreement with Lilly, we licensed from Lilly 35 issued United States patents, three pending United States patent applications, approximately 460 granted foreign patents and approximately 95 foreign national patent applications. We also have three pending United States patent applications filed in relation to aspects of oritavancin discovered by our scientists. After the patent related to the composition of oritavancin expires on November 24, 2015, we will not be able to use this patent to block others from marketing oritavancin in the United States. We believe, however, that under Hatch-Waxman legislation, the composition of matter patent covering oritavancin may be eligible to be extended for up to an additional five years.

Third parties may challenge the patents we license. Further, the patent applications that we license may fail to result in issued patents. Further, the existing or future patents to which we have rights based on our agreement with Lilly may be too narrow to prevent third parties from developing or designing around these patents. Manufacturers of generic drugs may also seek to obtain approval to sell a generic version of oritavancin prior to the expiration of the patent on the composition of oritavancin. If the sufficiency of the breadth or strength of protection provided by the patents we license with respect to oritavancin or the patents we pursue related to another product candidate is threatened, it could dissuade companies from collaborating with us to develop, and threaten our ability to commercialize oritavancin and our other product candidates. Further, if we encounter delays in our clinical trials, the period of time during which we could market our drug candidates under patent protection would be reduced.

In addition to the protection afforded by patents, we rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable, for processes for which patents are difficult to enforce and for any other elements of our drug discovery and development processes that involve proprietary know-how, information and technology that is not covered by patents. Although we require all of our employees, consultants, advisors and any third parties who have access to our proprietary know-how, information and technology to enter into confidentiality agreements, we cannot be certain that this know-how, information and technology will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. Further, the laws of some foreign countries do not protect proprietary rights to the same extent as the laws of the United States and Canada. As a result, we may encounter significant problems in protecting and defending our intellectual property both in the United States and abroad. If we are unable to prevent material disclosure of the intellectual property related to our technologies to third parties, we will not be able to establish or, if established, maintain a competitive advantage in our market, which could materially adversely affect our business, operating results and financial condition.

Third-party claims of intellectual property infringement may prevent or delay our drug discovery and development efforts.

Our commercial success depends in part on our avoiding infringement of the patents and proprietary rights of third parties. Third parties may assert that we are employing their proprietary technology without authorization. There may be third party patents with claims to materials, methods of manufacture or methods for treatment related to the use or manufacture of oritavancin and/or our other product candidates. Our commercial success depends in part on our avoiding infringement of the patents and proprietary rights of third parties. Third parties may assert that we are employing their proprietary technology without authorization. There may be third party patents with claims to materials, methods of manufacture or methods for treatment related to the use or manufacture of oritavancin and/or our other product candidates. At present, we are not aware of any patent claims with merit that would adversely and materially affect our ability to develop our product candidates. We are, however, aware of two United States patents, and European, Canadian and Japanese counterpart patents, with claims to naturally occurring molecules that may be produced in trace amounts as contaminants during the manufacture of oritavancin. Derivatives of these molecules may also be present in the final oritavancin product. Based on our review of the United States patents and their issued claims, we do not believe that their existence

 

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would block our ability to manufacture or commercialize oritavancin in the United States, assuming we receive regulatory approval to market oritavancin in the United States. Furthermore, both of these third-party United States patents will expire by the end of December 2008. Thus, it is likely that at least one, if not both, of the United States patents will be expired by the time we obtain approval to market oritavancin in the United States. We cannot rule out the possibility of third party allegations related to these or any other patents. If these or any other patents were held by a court of competent jurisdiction to cover the oritavancin manufacturing process, any molecules formed during the manufacturing process or the final oritavancin product itself, the holders of any such patents may be able to block our ability to commercialize oritavancin unless we obtained a license under the applicable patent or patents, or until such patents expire. We cannot predict whether we would be able to obtain a license on commercially reasonable terms, if at all. Any inability to obtain such a license under the applicable patents on commercially reasonable terms, or at all, may have a material adverse effect on our ability to commercialize oritavancin until such patents expire.

In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these patents. Furthermore, parties making claims against us may obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize one or more of our product candidates. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business. In the event of a successful claim of infringement against us, we may have to pay substantial damages, obtain one or more licenses from third parties or pay royalties. In addition, even in the absence of litigation, we may need to obtain licenses from third parties to advance our research or allow commercialization of our product candidates, and we have done so from time to time. We may fail to obtain future licenses at a reasonable cost or on reasonable terms, if at all. In that event, we may be unable to further develop and commercialize one or more of our product candidates, which could harm our business significantly.

We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive and time consuming.

Competitors may infringe our patents or the patents of our licensors. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours or our licensors is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation or defense proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly and could put our patent applications at risk of not issuing.

Interference proceedings brought by the United States Patent and Trademark Office may be necessary to determine the priority of inventions with respect to our patent applications or those of our collaborators or licensors. Litigation or interference proceedings may fail and, even if successful, may result in substantial costs and distraction of our management. We may not be able to prevent, alone or with our licensors, misappropriation of our proprietary rights, particularly in countries where the laws may not protect those rights as fully as in the United States.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock.

Product liability lawsuits could divert our resources, result in substantial liabilities and reduce the commercial potential of our medicines.

The risk that we may be sued on product liability claims is inherent in the development of pharmaceutical products. These lawsuits may divert our management from pursuing our business strategy and may be costly to

 

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defend. In addition, if we are held liable in any of these lawsuits, we may incur substantial liabilities and may be forced to limit or forgo further commercialization of those products.

Although we maintain general liability and product liability insurance, this insurance may not fully cover potential liabilities. In addition, inability to obtain or maintain sufficient insurance coverage at an acceptable cost or to otherwise protect against potential product liability claims could prevent or inhibit the commercial production and sale of our products, which could adversely affect our business, operating results and financial condition.

If we use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages.

Our research and development activities involve the controlled use of potentially hazardous substances, including chemical, biological and radioactive materials and viruses. In addition, our operations produce hazardous waste products. Federal, state and local laws and regulations in both the United States and Canada govern the use, manufacture, storage, handling and disposal of hazardous materials. Although we believe that our procedures for use, handling, storing and disposing of these materials comply with legally prescribed standards, we may incur significant additional costs to comply with applicable laws in the future. Also, even if we are in compliance with applicable laws, we cannot completely eliminate the risk of contamination or injury resulting from hazardous materials and we may incur liability as a result of any such contamination or injury. In the event of an accident, we could be held liable for damages or penalized with fines, and the liability could exceed our resources. We do not have any insurance for liabilities arising from hazardous materials. Compliance with applicable environmental laws and regulations is expensive, and current or future environmental regulations may impair our research, development and production efforts, which could harm our business, operating results and financial condition.

General Company-Related Risks

Our stock price may be volatile, and the value of our stock could decline.

The trading price of our common stock is likely to be volatile. Our stock price could be subject to wide fluctuations in response to a variety of factors, including the following:

 

   

any delay in filing our NDA for oritavancin and any adverse development or perceived adverse development with respect to the FDA’s review of the NDA, including without limitation the FDA’s issuance of a “refusal to file” letter or a request for additional information;

 

   

failure to meet or exceed revenue and financial projections we provide to the public;

 

   

actual or anticipated variations in quarterly operating results;

 

   

failure to meet or exceed the estimates and projections of the investment community;

 

   

adverse results or delays in clinical trials;

 

   

changes in laws or regulations applicable to our products, including but not limited to clinical trial requirements for approvals;

 

   

our decision to initiate a clinical trial, not to initiate a clinical trial or to terminate an existing clinical trial;

 

   

inability to obtain adequate product supply for any approved drug product or inability to do so at acceptable prices;

 

   

developments concerning our collaborations, including but not limited to those with our sources of manufacturing supply and our international commercialization partners;

 

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the termination of a collaboration or the inability to establish additional collaborations;

 

   

adverse regulatory decisions;

 

   

unanticipated serious safety concerns related to the use of oritavancin or any of our other product candidates;

 

   

introduction of new products or services offered by us or our competitors;

 

   

announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;

 

   

disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;

 

   

our failure to commercialize oritavancin, develop additional drug candidates and commercialize additional drug products;

 

   

additions or departures of key scientific or management personnel;

 

   

issuances of debt or equity securities;

 

   

significant lawsuits, including patent or stockholder litigation;

 

   

changes in the market valuations of similar companies;

 

   

sales of our common stock by us or our stockholders in the future;

 

   

trading volume of our common stock; and

 

   

other events or factors, many of which are beyond our control.

In addition, the stock market in general, and The Nasdaq Global Market and biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance. In the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has often been instituted against companies. This type of litigation, if instituted, could result in substantial costs and a diversion of management’s attention and resources, which would harm our business, operating results or financial condition.

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

The initial public offering price is substantially higher than the net tangible book value per share of our common stock. Investors purchasing common stock in this offering will pay a price per share that substantially exceeds the book value of our tangible assets after subtracting our liabilities. As a result, investors purchasing common stock in this offering will incur immediate dilution of $               per share, based on an initial public offering price of $               per share. Further, investors purchasing common stock in this offering will contribute approximately           % of the total amount invested by stockholders since our inception, but will own only approximately           % of the shares of common stock outstanding.

This dilution is due to our investors who purchased shares prior to this offering having paid substantially less than the price offered to the public in this offering when they purchased their shares and the exercise of stock options granted to our employees. In addition, as of June 15, 2007, options to purchase 1,800,616 shares of our common stock at a weighted average exercise price of $5.06 per share and warrants exercisable for up to 598,751 shares of our common stock at a weighted average price of $13.87 per share were outstanding. The exercise of any of these options or warrants would result in additional dilution. As a result of the dilution to investors purchasing shares in this offering, investors may receive significantly less than the purchase price paid in this offering, if anything, in the event of a liquidation of our Company.

 

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We will incur significant increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.

As a public company, we will incur significant legal, accounting and other expenses that we did not incur as a private company. In addition, the Sarbanes-Oxley Act, as well as rules subsequently implemented by the Securities and Exchange Commission and The Nasdaq Global Market, have imposed various new requirements on public companies, including requiring establishment and maintenance of effective disclosure and financial controls and changes in corporate governance practices. Our management and other personnel will need to devote a substantial amount of time to these new compliance initiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly. For example, we expect these rules and regulations to make it more difficult and more expensive for us to obtain director and officer liability insurance and we may be required to incur substantial costs to maintain the same or similar coverage.

The Sarbanes-Oxley Act requires, among other things, that we maintain effective internal controls for financial reporting and disclosure controls and procedures. In particular, we will be required to perform system and process evaluation and testing of our internal controls over financial reporting to allow management and our independent registered public accounting firm to report, commencing in our annual report on Form 10-K for the year ending December 31, 2008, on the effectiveness of our internal controls over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act. Our testing, or the subsequent testing by our independent registered public accounting firm, may reveal deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses. Our compliance with Section 404 will require that we incur substantial accounting expense and expend significant management efforts. We currently do not have an internal audit group, and we will need to hire additional accounting and financial staff with appropriate public company experience and technical accounting knowledge. Moreover, if we are not able to comply with the requirements of Section 404 in a timely manner or if we or our independent registered public accounting firm identifies deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses, the market price of our stock could decline and we could be subject to sanctions or investigations by Nasdaq, the Securities and Exchange Commission or other regulatory authorities, which would require additional financial and management resources.

Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.

Sales of a substantial number of shares of our common stock in the public market or the perception that these sales might occur, could depress the market price of our common stock and could impair our ability to raise capital through the sale of additional equity securities. We are unable to predict the effect that sales may have on the prevailing market price of our common stock.

Substantially all of our existing stockholders are subject to lock-up agreements with the underwriters of this offering that restrict the stockholders’ ability to transfer shares of our common stock for at least 180 days from the date of this prospectus. The lock-up agreements limit the number of shares of common stock that may be sold immediately following the public offering. Subject to certain limitations, approximately 11,374,891 of our total outstanding shares will be eligible for sale upon expiration of the lock-up period. In addition, shares issuable upon exercise of options and warrants vested as of the expiration of the lock-up period will be eligible for sale at that time. Sales of stock by these stockholders could have a material adverse effect on the trading price of our common stock.

Certain holders of shares of our common stock are entitled to rights with respect to the registration of their shares under the Securities Act of 1933, as amended (or the Securities Act), subject to the 180-day lock-up arrangement described above. Registration of these shares under the Securities Act would result in the shares becoming freely tradable without restriction under the Securities Act, except for shares purchased by affiliates. Any sales of securities by these stockholders could have a material adverse effect on the trading price of our common stock.

 

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Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.

We expect that significant additional capital will be needed in the future to continue our planned operations. To the extent we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution. We may sell common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time. If we sell common stock, convertible securities or other equity securities in more than one transaction, investors may be materially diluted by subsequent sales. Such sales may also result in material dilution to our existing stockholders, and new investors could gain rights superior to existing stockholders.

Pursuant to our 2007 Equity Incentive Plan, our management is authorized to grant stock options to our employees, directors and consultants. The number of shares available for future grant under our 2007 Equity Incentive Plan will automatically increase each year by an amount equal to 3.5% of all shares of our capital stock outstanding as of January 1 st of each year, subject to the ability of our board of directors to take action to reduce the size of such increase in any given year.

All of the shares of common stock sold in our initial public offering will be freely tradable without restrictions or further registration under the Securities Act, as amended, except for any shares purchased by our affiliates as defined in Rule 144 under the Securities Act. Rule 144 defines an affiliate as a person that directly, or indirectly through one or more intermediaries, controls, or is controlled by, or is under common control with, us and would include persons such as our directors and executive officers.

We have broad discretion in the use of the net proceeds from this offering and may not use them effectively.

Our management will have broad discretion in the application of the net proceeds, including for any of the purposes described in the section entitled “Use of Proceeds.” The failure by our management to apply these funds effectively could harm our business. Pending their use, we may invest the net proceeds from this offering in short-term, investment-grade, interest-bearing securities. These investments may not yield a favorable return to our stockholders.

Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.

Under Section 382 of the Internal Revenue Code, if a corporation undergoes an “ownership change” (generally defined as a greater than 50% change (by value) in its equity ownership over a three year period), the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes to offset its post-change income may be limited. We believe that, with our initial public offering, our most recent private placement and other transactions that have occurred over the past three years, we have triggered an “ownership change” limitation. We may also experience ownership changes in the future as a result of subsequent shifts in our stock ownership.

Some provisions of our charter documents and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders.

Provisions in our certificate of incorporation and bylaws, as well as provisions of Delaware law, could make it more difficult for a third party to acquire us or increase the cost of acquiring us, even if doing so would benefit our stockholders. These provisions include:

 

   

authorizing the issuance of “blank check” preferred stock, the terms of which may be established and shares of which may be issued without stockholder approval;

 

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limiting the removal of directors by the stockholders;

 

   

creating a staggered board of directors;

 

   

prohibiting stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of our stockholders;

 

   

eliminating the ability of stockholders to call a special meeting of stockholders;

 

   

permitting our board of directors to accelerate the vesting of outstanding option grants upon certain transactions that result in a change of control; and

 

   

establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings.

In addition, we are subject to Section 203 of the Delaware General Corporation Law, which generally prohibits a Delaware corporation from engaging in any of a broad range of business combinations with an interested stockholder for a period of three years following the date on which the stockholder became an interested stockholder, unless such transactions are approved by our board of directors. This provision could have the effect of delaying or preventing a change of control, whether or not it is desired by or beneficial to our stockholders. Further, other provisions of Delaware law may also discourage, delay or prevent someone from acquiring us or merging with us.

Our officers and directors and other affiliates may be able to exert significant control over the company.

After this offering, our executive officers, directors, 5% stockholders and their affiliates will control approximately           % of our outstanding common stock. Therefore, these stockholders will have the ability to influence the company through this ownership position.

These stockholders may be able to determine all matters requiring stockholder approval. For example, these stockholders may be able to control elections of directors, amendments of our organizational documents, or approval of any merger, sale of assets, or other major corporation transaction. This may prevent or discourage unsolicited acquisition proposals or offers for our common stock that you may feel are in your best interest as one of our stockholders.

Our corporate compliance program cannot ensure that we are in compliance with all applicable “fraud and abuse” laws and regulations and other applicable laws and regulations in the jurisdictions in which we sell oritavancin or other product candidates, and a failure to comply with these regulations or prevail in litigation related to noncompliance could harm our business.

Our general operations, and the research, development, manufacture, sale and marketing of our products, are subject to extensive laws and regulation, including but not limited to, health care “fraud and abuse” laws, such as the federal false claims act, the federal anti-kickback statute, and other state and federal laws and regulations. While we have developed and implemented a corporate compliance program based upon what we believe are current best practices, we cannot guarantee that this program will protect us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions.

 

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND PROJECTIONS

This prospectus contains forward-looking statements. Forward-looking statements relate to future events or our future financial performance. We generally identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar words. These statements are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, results of operations and financial condition. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties and other factors described in “Risk Factors” and elsewhere in this prospectus. Accordingly, you should not rely upon forward-looking statements as predictions of future events. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. We have identified below some important factors that could cause our forward-looking statements to differ materially from actual results, performance or financial condition:

 

   

the timing of regulatory filings and approvals;

 

   

the initiation, timing, progress and results of our drug discovery efforts, pre-clinical studies, clinical trials and other development efforts;

 

   

our ability to advance product candidates into clinical trials;

 

   

the further clinical development and commercialization of our product candidates;

 

   

the implementation of our business model, strategic plans for our business and product candidates;

 

   

the loss of key personnel;

 

   

the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates;

 

   

our ability to operate our business without infringing the intellectual property rights of others;

 

   

estimates of our expenses, future revenues, capital requirements and our needs for additional financing, as well as the availability of necessary financing on attractive terms;

 

   

assuming regulatory approval and commercialization of our product candidates, market acceptance of the products we develop;

 

   

our use of proceeds from this offering;

 

   

our financial performance;

 

   

competitive companies, technologies and our industry; and

 

   

other factors discussed elsewhere in this prospectus.

The forward-looking statements made in this prospectus relate only to events as of the date on which the statements are made. We undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events, new information, future earnings or otherwise.

This prospectus also contains market data related to our business and industry. This market data includes projections that are based on a number of assumptions. If these assumptions turn out to be incorrect, actual results may differ from the projections based on these assumptions. As a result, our markets may not grow at the rates projected by this data, or at all. The failure of these markets to grow at these projected rates may have a material adverse effect on our business, results of operations and financial condition and the market price of our common stock.

 

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USE OF PROCEEDS

We will receive net proceeds of approximately $             million from the sale of              shares of common stock at the assumed initial public offering price of $             per share, after deducting underwriting commissions and discounts of $             million and estimated expenses of $             million. A $1.00 increase (decrease) in the assumed initial public offering price of $             would increase (decrease) the net proceeds to us from this offering by $            , assuming the number of shares offered by us, as set forth on the cover of this prospectus remains the same and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us. If the underwriters exercise their over-allotment option in full, then the net proceeds will be approximately $             million.

The principal purposes of this offering are to obtain additional capital, to create a public market for our common stock and to facilitate our future access to the public equity markets. We anticipate using the net proceeds from this offering:

 

   

to fund internal and external costs in connection with our anticipated NDA submission for oritavancin in the United States and for other regulatory filings thereafter in Europe;

 

   

to fund clinical trials for oritavancin in cSSSI using a single administration and to continue the clinical development of oritavancin for other indications such as bacteremia;

 

   

to fund commercial launch-related expenses for oritavancin including manufacturing, marketing, and sales, in anticipation of regulatory approval;

 

   

to make regularly scheduled payments on existing debt facilities;

 

   

to apply the remaining funds for general corporate purposes and the potential acquisition of, or investment in, technologies, products, or companies that complement our business.

We have no current understandings, commitments, or agreements with respect to any acquisition of or investment in any technologies, products, or companies.

The amounts and timing of our actual expenditures will depend upon numerous factors, including whether we obtain FDA approval for oritavancin and, if so, the timing of such approval, the success of the commercial launch of oritavancin if approved by the FDA, our cash flows from operations and the anticipated growth of our business. Management will have significant flexibility in applying the net proceeds from this offering. See “Risk Factors—Risks Related to this Offering.” Pending any use, the net proceeds of this offering will be invested in short-term, interest-bearing investment-grade securities.

 

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DIVIDEND POLICY

Our board of directors will have discretion in determining whether to declare or pay dividends, which will depend upon our financial condition, results of operations, capital requirements and such other factors as the board of directors deems relevant. We currently anticipate that we will retain any future earnings for the development, operation and expansion of our business and do not anticipate paying dividends in the foreseeable future. Moreover, our loan agreement relating to our credit facility with Investissement Québec imposes restrictions on our ability to declare and pay dividends. We may also incur future indebtedness that will limit our ability to declare and pay dividends.

 

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CAPITALIZATION

The following table sets forth our capitalization as of March 31, 2007:

 

   

on an actual basis;

 

   

on a pro forma basis to give effect, upon the closing of this offering, to the conversion of 9,935,665 shares of our convertible preferred stock into an aggregate of 11,437,520 shares of common stock; and

 

   

on a pro forma as adjusted basis to give effect to the sale by us of              shares of common stock at an assumed initial public offering price of $             per share, after deducting underwriting discounts and commissions and estimated offering expenses.

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

 

   

As of March 31, 2007

(unaudited)

    Actual    

Pro Forma

    Pro Forma
As Adjusted
    (in thousands, except share and per share data)

Cash, cash equivalents and short-term investments

  $ 58,032     $ 58,032    
                   

Note payable

    7,565       7,565    

Deferred rent

    46       46    

Warrants to purchase shares subject to redemption

    1,181       1,181    

Stockholders’ equity:

     

Series A convertible preferred stock, par value $0.0001 per share, 20,000 shares authorized, 15,643 shares issued and outstanding, actual; no shares authorized, issued or outstanding, on a pro forma basis or on a pro forma as adjusted basis

    1,458       —      

Series B convertible preferred stock, par value $0.0001 per share, 245,000 shares authorized, 143,860 shares issued and outstanding, actual; no shares authorized, issued or outstanding, on a pro forma basis or on a pro forma as adjusted basis

    15,198       —      

Series C-1 convertible preferred stock, par value $0.0001 per share, 3,200,000 shares authorized, 2,361,017 shares issued and outstanding, actual; no shares authorized, issued or outstanding on a pro forma basis or on a pro forma as adjusted basis

    22,557       —      

Series C-2 convertible preferred stock, par value $0.0001 per share, 1,600,000 shares authorized; 1,081,171 shares issued and outstanding, actual; no shares authorized, issued or outstanding on a pro forma basis or on a pro forma as adjusted basis

    10,665       —      

Series C-3 convertible preferred stock, par value $0.0001 per share, 9,500,000 shares authorized, 6,333,974 shares issued and outstanding, actual; no shares authorized, issued or outstanding on a pro forma basis or on a pro forma as adjusted basis

    64,199       —      

Common stock, par value $0.0001 per share, 32,000,000 shares authorized; 20,230 shares issued and outstanding, actual; 32,000,000 shares authorized, 11,457,750 shares issued and outstanding on a pro forma basis;              shares authorized,              shares issued and outstanding on a pro forma, as adjusted basis(1)

    —         1    

Additional paid-in capital(1)

    14,649       128,725    

Accumulated other comprehensive income

    1,519       1,519    

Accumulated deficit

    (82,302 )     (82,302 )  
                   

Total stockholders’ equity(1)

    47,943       47,943    
                   

Total capitalization(1)

  $ 56,735     $ 56,735    
                   

 

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(1)   A $1.00 increase (decrease) in the assumed initial public offering price of $             would increase (decrease) each of cash and cash equivalents, common stock, additional paid-in capital, total stockholders’ equity and total capitalization by $             million, assuming the number of shares offered by us, as set forth on the cover of this prospectus, remains the same after deducting the underwriting discounts and commissions and estimated offering expenses payable by us.

The number of shares of our common stock outstanding following this offering is based on 11,457,750 shares of our common stock outstanding as of June 15, 2007, and excludes:

 

   

2,051,749 shares of our common stock reserved for issuance under our stock plan, of which options to purchase 1,800,616 shares of our common stock are outstanding at a weighted average price of $5.06 per share;

 

   

the issuance of up to 598,751 shares of our common stock upon the exercise of outstanding warrants at a weighted average price of $13.87 per share, all of which are currently exercisable; and

 

   

shares potentially issuable to InterMune upon our future achievement of a milestone under our agreements with InterMune, consisting of 358,798 shares of our Series C-2 preferred stock and 358,797 shares of our Series C-3 preferred stock, as well as a warrant exercisable for up to 35,553 shares of our Series C-1 preferred stock.

 

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DILUTION

As of March 31, 2007, we had a historical net tangible book value of $47.9 million, or approximately $2,369.88 per share of common stock. Historical net tangible book value per share represents the amount of our total tangible assets less our total liabilities, divided by the number of shares of common stock outstanding. Pro forma net tangible book value per share represents the amount of our total tangible assets less our total liabilities, divided by the total number of shares of common stock outstanding, as of March 31, 2007, after giving effect to the conversion of all of our series A convertible preferred stock, series B convertible preferred stock and series C convertible preferred stock into shares of our common stock upon the closing of this offering.

After giving effect to this offering and the receipt of $             million of net proceeds from this offering, based on an assumed initial public offering price of $             per share, the midpoint of the price range set forth on the front cover of this prospectus, the pro forma net tangible book value of our common stock as of March 31, 2007, would have been $             million, or $             per share. This amount represents an immediate increase in net tangible book value of $             per share to the existing stockholders and an immediate dilution in net tangible book value of $             per share to purchasers of our common stock in this offering. Dilution is determined by subtracting pro forma net tangible book value per share after this offering from the amount of cash paid by a new investor for a share of common stock. The new investors will have paid $             per share even though the per share value of our assets after subtracting our liabilities is only $            . In addition, the total consideration from new investors will be $             million, which is         % of the total of $             million paid for all shares of common stock outstanding, but new investors will own only         % of our outstanding shares of common stock. The following table illustrates such dilution:

 

Assumed initial public offering price per share

     $         

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

   $ 2,369.88    

Decrease per share attributable to conversion of convertible preferred stock

     (2,365.70 )  
          

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

   $ 4.18    

Increase per share attributable to new investors

    

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

    

Dilution of net tangible book value per share to new investors in this offering

     $  
        

Each $1.00 increase (decrease) in the public offering price per share would increase (decrease) the pro forma net tangible book value by $             per share (assuming no exercise of the underwriters’ option to purchase additional shares) and the dilution to investors in this offering by $             per share, assuming that the number of shares offered in this offering as set forth on the front cover of this prospectus remains the same.

If the underwriters exercise their over allotment option in full, the pro forma net tangible book value per share after the offering would have been $             million, or $             per share. This amount represents an immediate increase in net tangible book value of $             per share to the existing stockholders and an immediate dilution in net tangible book value of $             per share to purchasers of our common stock in this offering.

 

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The following table sets forth, as of March 31, 2007, on the pro forma basis described above, the number of shares of common stock purchased from us, the total consideration paid to us and the average price per share paid by existing stockholders and by new investors who purchase shares of our common stock in this offering, before deducting the underwriting discounts and commissions and estimated offering expenses.

 

     Shares Purchased     Total Consideration    

Average
Price

Per Share

       Number    Percent     Amount    Percent    
     (In thousands, except share and per share data)

Existing stockholders

   11,457,750             %   $ 98,662             %   $ 8.61

New investors

               %               %  
                              

Total

      100 %   $      100 %  
                              

Both of the tables above reflect the conversion of 15,643 shares of our series A convertible preferred stock; 143,860 shares of our series B convertible preferred stock; 9,776,162 shares of our series C convertible preferred stock into an aggregate of 11,437,520 shares of common stock upon the closing of this offering; and assumes no exercise of the underwriter’s allotment option and no exercise of stock options or warrants after March 31, 2007. As of March 31, 2007, we had outstanding options to purchase a total of 46,017 shares of common stock at a weighted average exercise price of $50.94 per share and outstanding warrants to purchase a total of 8,200 shares of our series B convertible preferred stock at a weighted average exercise price of CAN$234.00 or US $202.67 per share, warrants to purchase a total of 484,354 shares of our Series C-1 convertible preferred stock at an exercise price of $13.06 per share and warrants to purchase a total of 29,855 shares of common stock at an exercise price of $10.45157 per share. To the extent that outstanding options or warrants are exercised in the future, there will be further dilution to new investors.

 

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SELECTED CONSOLIDATED FINANCIAL DATA

This section presents our historical financial data. You should read the selected financial data below in conjunction with “Management’s discussion and analysis of financial condition and results of operations” and our consolidated financial statements and related notes included elsewhere in this prospectus. The selected financial data in this section are not intended to replace the consolidated financial statements. We have derived the statement of operations data for the years ended May 31, 2004 and 2005, the seven months ended December 31, 2005, the year ended December 31, 2006 and the period from May 20, 1997 (date of inception) through December 31, 2006 and the balance sheet data as of December 31, 2005 and 2006 from our consolidated financial statements included elsewhere in this prospectus, which have been audited by Ernst & Young LLP, independent registered public accounting firm. We have derived the consolidated statements of operations data for the years ended May 31, 2002 and 2003 and the consolidated balance sheet data as of May 31, 2002, 2003, 2004 and 2005 from a reconciliation to United States GAAP of audited Canadian GAAP financial statements, which have not been audited for United States GAAP purposes. These financial statements are not included herein. The statement of operations data for the three months ended March 31, 2006 and 2007 and for the period from May 20, 1997 (date of inception) through March 31, 2007, and the balance sheet data as of March 31, 2007 have been derived from our unaudited interim consolidated financial statements included elsewhere in this prospectus. In the opinion of management, the unaudited consolidated financial statements have been prepared on the same basis as the audited consolidated statements and contain all adjustments necessary for the fair presentation of our results of operations for these periods and financial position as of such dates. See the notes to the consolidated financial statements for an explanation of the method used to determine the number of shares used in determining basic and diluted and pro forma basic and diluted net loss per common share. Pro forma basic and diluted net loss per common share have been calculated assuming the conversion of all outstanding shares of convertible preferred stock, redeemable convertible preferred stock and convertible debt at the beginning of the period (or at the original date of issuance, if later) into common stock. In 2005, we changed our fiscal year end from May 31 to December 31.

 

     

Year

Ended

May 31,

2002

   

Year

Ended

May 31,

2003

   

Year

Ended

May 31,

2004

   

Year

Ended

May 31,

2005

   

Seven Months
Ended

December 31,

2005

   

Year

Ended

December 31,

2006

    Three Months
Ended
March 31,
   

For the Period
from May 20,
1997 (date of
inception)
through
March 31,

2007

 
                  2006     2007    
          Restated     Restated     Restated     Restated     Restated              
    (unaudited)     (unaudited)                            

(unaudited)

   

(unaudited)

 
    (in thousands, except share and per share data)              

Statement of operations data:

 

               

Operating expenses

                 

Research and development

  $ 1,508     $ 2,556     $ 5,198     $ 4,503     $ 2,319     $ 11,456     $ 2,179     $ 5,439     $ 36,186  

Acquired in-process research and development

    —         —         —         —         11,847       —         —         9,500       21,347  

General and administrative

    626       1,174       1,506       1,388       2,108       3,352       561       1,935       13,065  
                                                                       

Total operating expenses

    2,134       3,730       6,704       5,891       16,274       14,808       2,740       16,874       70,598  
                                                                       

Other income (expense)

                 

Interest income

    54       139       125       78       31       280       84       458       1,373  

Interest expense

    (26 )     (46 )     (41 )     (211 )     (852 )     (14,968 )     (4,229 )     (2,210 )     (18,434 )

Foreign exchange gain (loss)

    —         —         —         —         15       (214 )     (9 )     (64 )     (264 )

Gain on disposal of property and equipment

    —         12       —         —         —         —         —         —         47  
                                                                       

Other income (expense), net

    28       105       84       (133 )     (806 )     (14,902 )     (4,154 )     (1,816 )     (17,278 )
                                                                       

Loss before income tax (expense) benefit

    (2,106 )     (3,625 )     (6,620 )     (6,024 )     (17,080 )     (29,710 )     (6,894 )     (18,690 )     (87,876 )

 

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Year

Ended

May 31,

2002

   

Year

Ended

May 31,

2003

   

Year

Ended

May 31,

2004

   

Year

Ended

May 31,

2005

   

Seven Months
Ended

December 31,

2005

   

Year

Ended

December 31,

2006

    Three Months
Ended March 31,
   

For the Period
from May 20,
1997 (date of
inception)
through
March 31,

2007

 
                  2006     2007    
          Restated     Restated     Restated     Restated     Restated              
    (unaudited)     (unaudited)                             (unaudited)     (unaudited)  
    (in thousands, except share and per share data)              

Income tax (expense) benefit

    696       630       776       759       1,491       (431 )     (99 )     (29 )     5,574  
                                                                       

Net loss

  $ (1,410 )   $ (2,995 )   $ (5,844 )   $ (5,265 )   $ (15,589 )   $ (30,141 )   $ (6,993 )   $ (18,719 )   $ (82,302 )
                                                                       

Net loss per share—basic and diluted

  $ (82.88 )   $ (185.90 )   $ (344.16 )   $ (305.33 )   $ (791.46 )   $ (1,582.84 )   $ (368.89 )   $ (936.41 )  
                                                                 

Weighted average number of common shares used in net loss per share—basic and diluted

    18,908       19,469       20,209       20,216       20,230       20,230       20,230       20,230    

Unaudited

                 

Pro forma net loss per share—basic and diluted

            $ (122.86 )     $ (2.23 )  

Shares used in computing pro forma net loss per share—basic and diluted

              298,918         11,457,750    

 

     

May 31,

2002

   

May 31,

2003

   

May 31,

2004

   

May 31,

2005

   

December 31,

2005

   

December 31,

2006

    March 31,
2007
 
    (unaudited)    

Restated

(unaudited)

   

Restated

(unaudited)

   

Restated

(unaudited)

    Restated     Restated    

(unaudited)

 
    (in thousands)        

Balance sheet data:

             

Cash, cash equivalents and short-term investments

  $ 4,656     $ 7,732     $ 1,767     $ 2,572     $ 12,209     $ 12,533     $ 58,032  

Working capital (deficit)

    4,802       8,238       2,986       3,422       10,263       (9,895 )     55,705  

Total assets

    6,619       10,325       5,342       5,299       16,169       15,214       61,587  

Note payable

    —         —         (59 )     3,833       6,529       7,297       7,565  

Convertible debt

    —         —         —         —         9,702       28,516       —    

Long-term portion of capital lease obligations

    355       430       183       15       —         —         —    

Series B redeemable convertible preferred stock

    5,064       10,953       12,064       12,972       13,094       14,974       —    

Deficit accumulated during the development stage

    (3,749 )     (6,744 )     (12,588 )     (17,854 )     (33,442 )     (63,584 )     (82,302 )

Total stockholders’ (deficit) equity

    407       (2,225 )     (8,733 )     (14,294 )     (18,948 )     (41,489 )     47,943  

 

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (RESTATED)

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our consolidated financial statements and their notes appearing elsewhere in this prospectus. The following discussion contains forward-looking statements that involve risks and uncertainties. Our actual results and the timing of certain events could differ materially from those anticipated in these forward-looking statements as a result of certain factors, including those discussed below and elsewhere in this prospectus, particularly under the heading “Risk Factors.”

Restatement

As disclosed under the heading “Restatement” in Note 2.A to the consolidated financial statements, we have restated our consolidated financial statements as of December 31, 2005 and 2006 and for the years ended May 31, 2004 and 2005, the seven months ended December 31, 2005, the year ended December 31, 2006 and the period from May 20, 1997 (date of inception) through December 31, 2006 in our initial Registration Statement on Form S-1 due to the discovery of errors in accounting for the Canadian Part VI.I tax requirement.

Overview

We are a biopharmaceutical company focused on the development and commercialization of innovative antibiotics for serious infections treated or acquired in hospitals and other institutional settings. We are developing oritavancin, a novel intravenous antibiotic, for the treatment of serious gram-positive bacterial infections including cSSSI and bacteremia. We expect to submit an NDA for oritavancin for the treatment of cSSSI in the first quarter of 2008 and hope to receive regulatory approvals in late 2008 in the United States and thereafter in Europe. We plan on commercializing oritavancin through our own direct sales force in the United States and in select other countries, and to out-license oritavancin to third parties in other countries as we deem appropriate. In addition, we have discovered another antibiotic that is currently in pre-clinical development for osteomyelitis, and we continually evaluate opportunities for potential in-licensing of other antibiotics for the treatment of hospital-based infections.

We acquired worldwide rights to oritavancin from InterMune in December 2005, and believe that since then we have greatly improved the commercial and economic prospects for the drug by resolving several important issues with the FDA and by substantially lowering the royalty rate that may be payable to Lilly, the original discoverer of oritavancin. Our strategy is to capitalize on the unique attributes of oritavancin to develop it into a leading therapy worldwide for the treatment of serious gram-positive infections, initially for cSSSI and subsequently for other indications.

We are incorporated as a Delaware corporation, effective December 6, 2005, with two subsidiaries in Canada, and we initiated operations through our Canadian subsidiary in May 1997 in Montreal, Québec. To date, we have dedicated substantially all of our activities to the research and development of our drug candidates. Accordingly, we are considered to be in the development stage at December 31, 2006, as defined in Statement of Financial Accounting Standards (“ SFAS ”) No. 7, “ Accounting and Reporting by Development Stage Enterprises .” Our fiscal year ends on December 31 and we operate as one reportable segment. In 2005, we changed our fiscal year end from May 31 to December 31. Prior to our acquisition of oritavancin in December 2005, we were focused on early-stage research in the area of antibiotics and the application of our phage technology.

We have not generated any revenue to date from product sales and have incurred significant operating losses since our inception in 1997. We incurred net losses of $5.8 million and $5.3 million in fiscal years ended May 31, 2004 and 2005, respectively, and $15.6 million for the seven months ended December 31, 2005, $30.1 million for the fiscal year ended December 31, 2006 and $18.7 million for the three months ended March 31, 2007. As of March 31, 2007, we had a deficit accumulated during the development stage of $82.3 million, restated, and we expect to incur losses for the foreseeable future.

We expect to incur substantial expenditures in the foreseeable future for the continued development of our product candidates and, if we obtain regulatory approval, for the commercialization of those products. We expect

 

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to continue to incur operating losses for at least the next several years, and we will need additional financing to support our activities. We will seek to fund our operations through public or private equity or debt financings or other sources, such as collaborations. Adequate additional funding may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed could have a negative impact on our financial condition and our ability to pursue our business strategies. If adequate funds are not available to us, we may be required to delay, reduce or eliminate research and development programs, reduce or eliminate commercialization efforts, obtain funds through arrangements with collaborators or others on terms unfavorable to us or pursue merger or acquisition strategies.

Financial Obligations Related to License of Oritavancin

Lilly License Agreement

In December 2005, in connection with our acquisition from InterMune of assets related to oritavancin, we became a party to a license agreement with Lilly pursuant to which we acquired worldwide license rights to patents and other intellectual property related to oritavancin. Pursuant to the license agreement, we are obligated to make the following milestone payments to Lilly:

 

Milestone

   Required Payment

First regulatory approval of oritavancin for the treatment of infectious diseases other than complicated skin and skin structure infections and catheter-related bloodstream infections

   $ 10,000,000

Second regulatory approval of oritavancin for the treatment of infectious diseases other than complicated skin and skin structure infections and catheter-related bloodstream infections

   $ 10,000,000

First calendar year in which net sales exceed $210,000,000

   $ 15,000,000

In addition, pursuant to the license agreement, we are obligated to pay Lilly certain royalties based on our net sales of oritavancin drug product in any calendar year in any jurisdiction in which, under the license agreement, we hold license rights to a valid patent. These royalty obligations are calculated on an aggregate, tiered basis with the royalty percentage increasing based on our realization of qualifying net sales in any calendar year above established thresholds. Under the license agreement, qualifying net sales are sales of oritavancin (or any other product) covered by a patent we license from Lilly, net of customary deductions, in any jurisdiction in which a patent we license from Lilly remains valid. For purposes of calculating qualifying net sales during any particular time period, a sale is deemed to be made at the time the oritavancin (or other) drug product is shipped to the customer, regardless of whether we have received payment at that time. Under the license agreement, we may be obligated to pay the following royalties to Lilly:

       Qualifying
annual net
sales up to
$200,000,000
    Qualifying
annual net
sales in
excess of
$200,000,000
and up to
$400,000,000
    Qualifying
annual net
sales in
excess of
$400,000,000
 

Annual royalty rate on qualifying net sales

   10 %   12 %   18 %

Under the license agreement with Lilly, our license rights continue on a country-by-country basis until there are no further royalty obligations in a specific country, at which time we will have a fully paid-up, perpetual, irrevocable, exclusive, sublicenseable license to make, have made, use, offer to sell, sell and import oritavancin in fields relating to infectious diseases in the applicable country.

InterMune Agreement

In connection with our acquisition of the worldwide rights to oritavancin from InterMune in December 2005, we entered into an asset purchase agreement with InterMune pursuant to which we agreed to pay InterMune a total of up to $25 million in convertible debt and $9 million in cash, such payments to be in the form of both initial payments and future milestone payments. In addition, we agreed to pay Lilly $1 million in cash, which payment was made in January 2006. As of April 15, 2007, due to the consummation of our acquisition of the worldwide rights to oritavancin and our achievement of an initial milestone, we had made payments to InterMune that totaled

 

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$4.0 million and recorded a total of $17.5 million in convertible debt (all of which has converted into shares of our capital stock). All cash payments to Lilly and InterMune, as well as convertible debt, have been recorded as acquired in-process research and development expenses in the consolidated financials statements.

Pursuant to the asset purchase agreement, as amended to date, and the related convertible promissory note we issued to InterMune, as also amended to date, we will issue InterMune additional convertible debt worth $7.5 million, which debt will immediately and automatically convert into shares of our capital stock, upon the earlier to occur of (a) our receipt of authorization from the FDA (whether verbal or written) to conduct, or our first dosing of a subject in, a clinical study of oritavancin in the United States, which clinical study is designed to assess the efficacy of oritavancin (excluding for this purpose any clinical study for cSSSI with a single daily intravenous dose of 200 mg/day of oritavancin (or 300 mg/day for patients weighing greater than 110 kg)); or (b) the consummation of our initial public offering. In addition, we are obligated to make a further $5 million cash payment to InterMune if and when we receive from the FDA all approvals necessary for the commercial launch of oritavancin. We have no other milestone or royalty obligations to InterMune in connection with our December 2005 acquisition of the worldwide rights to oritavancin.

Financial Overview

Revenue. We have not generated any product revenue since our inception and do not expect to generate any revenue from the sale of products unless we receive regulatory approval for commercial sale of oritavancin. We also may seek to generate revenue from collaborative partners through a combination of up-front license fees, milestone payments, and royalties. Since our inception, we have not entered into any revenue-generating collaboration arrangements.

Research and development expense. Research and development expense consists of expenses incurred in connection with the discovery and development of our product candidates. These expenses consist primarily of salaries and related expenses, allocated facility costs and third-party contract costs relating to research, formulation, manufacturing, pre-clinical study and clinical trial activities. We charge all research and development expenses to operations as incurred. We expect our research and development costs to be substantial and to increase as we conduct further clinical trials on oritavancin for additional indications and advance other product candidates into pre-clinical studies and clinical trials.

Assuming we receive regulatory approval for oritavancin for the treatment of cSSSI, after the initial launch of oritavancin, we expect to continue to incur significant research and development costs as we perform additional clinical trials in order to apply for regulatory approval for additional indications, as well as to advance our additional product candidates. We cannot predict the timing or total cost of completion of these efforts as they are dependent on our discussions with regulatory agencies on clinical trial design and our ability to achieve clinical objectives, which is inherently uncertain. As a result of these uncertainties, we are unable to determine the duration and completion costs of these development activities or whether, when and to what extent we may generate revenues based upon additional indications for oritavancin. Our inability to complete our research and development projects in a timely manner could significantly increase our capital requirements and could adversely impact our liquidity. These uncertainties could require us to seek additional, external sources of financing from time to time in order to continue to pursue our strategy. Our inability to raise additional capital, or to do so on terms reasonably acceptable to us, would jeopardize the future success of our business.

Acquired in-process research and development expense. Acquired in-process research and development expense primarily consists of payments due to InterMune and Lilly for a total of $3.0 million related to our agreement with InterMune and the discounted value of the convertible note issued to InterMune of approximately $8.8 million. In the three months ended March 31, 2007, acquired in-process research and development expense was comprised of an expense of $9.5 million, consisting of a $2.0 million payment and a $7.5 million increase in the value of the InterMune note upon our achievement of an initial milestone. We expect to incur additional acquired in-process research and development expense as we meet additional milestones under our agreement with InterMune and are required to make additional payments to InterMune.

 

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General and administrative expenses. General and administrative expense consists primarily of salaries and related expenses for personnel in our administrative, finance, business development and human resource functions. Other costs include legal costs of pursuing patent protection of our intellectual property, allocated facility costs and professional fees for accounting and legal services. After this offering, we anticipate increases in general and administrative expense relating to the additional expense of operating as a public company. These increases will likely include legal fees, accounting fees and directors’ and officers’ insurance premiums, as well as fees for investor relations services.

Interest expense. Interest expense consists primarily of interest, amortization of beneficial conversion features and debt discount, and amortization of deferred financing costs associated with our note payable and convertible debt issued in December 2005 and convertible debentures issued in 2006. In the seven months ended December 31, 2005 and the year ended December 31, 2006, approximately $529,000 and $12.5 million, respectively, of interest expense was related to the amortization of the beneficial conversion features and debt discount associated with the convertible debt. In the three months ended March 31, 2007, interest expense was $2.2 million. The decrease in interest expense is due to our convertible debt converting into shares of our preferred stock and the remaining unamortized debt discount and beneficial conversion features having been charged to interest expense upon the closing of our Series C financing transaction.

Results of Operations

Three months ended March, 31 2007 compared to three months ended March, 31 2006 (unaudited)

Revenue . We recorded no revenue during the three months ended March 31, 2007 or 2006.

Research and development expense . Research and development expense during the three months ended March 31, 2006 and 2007 was as follows:

 

     Three months ended
March 31,
   Change  
         2006            2007        $    %  
     ($ in thousands)  

Research and development

   $ 2,179    $ 5,439    $ 3,260    149.6 %

Research and development expense for the three months ended March 31, 2007 was $5.4 million, compared to $2.2 million for the three months ended March 31, 2006. The increase during the three months ended March 31, 2007 in research and development expense was primarily the result of a $1.5 million increase in research contract expense, which increased from $476,000 to $2.0 million primarily due to an increase of $1.3 million for third party product manufacturing and validation work in preparation for the commercial launch of oritavancin, an increase of $500,000 due to in-vitro clinical database work performed for the oritavancin program and partially offset by a $300,000 reduction in clinical data management performed for the oritavancin program; a $819,000 increase in salaries and benefits expense, which increased from $825,000 to $1.6 million mainly due to the hiring of 20 development employees related to the oritavancin program; a $679,000 increase in scientific consulting expense, which increased from $279,000 to $958,000, primarily due to preparation for the oritavancin NDA submission; a $135,000 increase in laboratory supply costs, comprised of non-capital consumable and durable goods used in research activities, which increased from $166,000 to $301,000 mainly due to increased testing activities for the oritavancin program and a $128,000 increase in conference and travel expense, which increased from $98,000 to $226,000 primarily due to an increased level of activity and increased employee base.

 

     Three months
ended March 31,
   Change  
         2006            2007        $    %  
     ($ in thousands)  

Acquired in-process research and development

   $ —      $ 9,500    $ 9,500    100.0 %

Acquired in-process research and development expense for the three months ended March 31, 2007 was $9.5 million, compared to no expense for the three months ended March 31, 2006. The increase during the three

 

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months ended March 31, 2007 in acquired in-process research and development expenses was due to the $7.5 million increase in the InterMune note upon our achievement of an initial milestone and due to our series C financing during the first quarter of 2007, plus a $2.0 million milestone cash payment made to InterMune in the first quarter of 2007.

General and administrative expense . General and administrative expense during the three months ended March 31, 2006 and 2007 was as follows:

 

     Three months
ended March 31,
   Change  
         2006            2007        $    %  
     ($ in thousands)  

General and administrative

   $ 561    $ 1,935    $ 1,374    244.9 %

General and administrative expense for the three months ended March 31, 2007 was $1.9 million, compared to $561,000 for the three months ended March 31, 2006. The increase during the three months ended March 31, 2007 in general and administrative expense was primarily the result of a $539,000 increase in the amounts paid for legal, accounting and consulting fees, which increased from $255,000 to $794,000 primarily due to an increase of $210,000 in audit and accounting service fees related to the 2005 and 2006 audits, an increase of $167,000 in patent renewal and maintenance fees for the oritavancin patent estate and an increase of $162,000 in recruiting and information technology consulting fees; a $417,000 increase in salaries and benefits expenses, which increased from $147,000 to $564,000 primarily due to the hiring of additional administrative staff (including our Chief Executive Officer and Chief Financial Officer); and a $206,000 increase in amounts paid for marketing expenses, which increased from $28,000 to $234,000 mainly due to market research for oritavancin.

Interest income . Interest income for the three months ended March 31, 2006 and 2007 was as follows:

 

     Three months
ended March 31,
   Change  
         2006            2007        $    %  
     ($ in thousands)  

Interest income

   $ 84    $ 458    $ 374    445.2 %

Interest income for the three months ended March 31, 2007 was $458,000, compared to $84,000 for the three months ended March 31, 2006. The increase in interest income for the three months ended March 31, 2007 was due to higher average cash and cash equivalent balances during the three months ended March 31, 2007, due to the receipt of approximately $14.0 million of net proceeds from our December 2006 convertible debenture financing and approximately $57.8 million of net proceeds from our January and February 2007 closings of our series C financing.

Interest expense . Interest expense for the three months ended March 31, 2006 and 2007 was as follows:

 

     Three months
ended March 31,
    Change  
         2006             2007         $    %  
     ($ in thousands)  

Interest expense

   $ (4,229 )   $ (2,210 )   $ 2,019    47.7 %

Interest expense for the three months ended March 31, 2007 was $2.2 million compared to $4.2 million for the three months ended March 31, 2006. The decrease in interest expense of $2.0 million for the three months ended March 31, 2007 was primarily due to a decrease of $2.1 million in interest on the convertible promissory notes issued in October 2005, December 2005 and December 2006 due to lower overall debt balances as a result of the January 2007 conversion of these notes into shares of series C preferred stock; $147,000 decrease due to a

 

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lower incremental change in the fair value of the warrants issued to Investissement Québec (“IQ”), the Company’s lender, partially offset by an increase in interest expense on the IQ loan of $27,000 and partially offset by a $249,000 increase in amortization of deferred financing costs due to the expense associated with the closing of our series C financing transaction.

Income tax benefit (expense) . Income tax benefit or expense represents a refundable tax credit provided by the Canadian and Ontario and Québec provincial governments, calculated based on the amount of research and development expenses deemed to be allowable under applicable Canadian tax law, as well as the Canadian Part VI.I tax related to the cumulative dividend on the series B redeemable convertible preferred stock. Allowable expenses are primarily expense items like salary and benefits for research and development staff. Income tax benefit (expense) for the three months ended March 31, 2006 and 2007 was as follows:

 

     Three months
ended March 31,
    Change  
         2006             2007         $    %  
     ($ in thousands)  

Income tax expense

   $ (99 )   $ (29 )   $ 70    70.7 %

Income tax expense for the three months ended March 31, 2007 was $29,000, compared to $99,000 for the three months ended March 31, 2006. The decrease in income tax expense for the three months ended March 31, 2007 resulted from a decrease in the Part VI.I income tax expense of $102,000, which decreased from $204,000 to $102,000, and was partially offset by lower qualifying research and development expenses.

Year ended December 31, 2006 compared to year ended May 31, 2005

Revenue . We recorded no revenue in the fiscal years ended May 31, 2005 or December 31, 2006.

Research and development expense . Research and development expense during the fiscal years ended May 31, 2005 and December 31, 2006 was as follows:

 

     Year ended    Change  
     May 31,
2005
   December 31,
2006
   $    %  
     ($ in thousands)  

Research and development

   $ 4,503    $ 11,456    $ 6,953    154.4 %

Research and development expense for the fiscal year ended December 31, 2006 was $11.5 million, compared to $4.5 million for the fiscal year ended May 31, 2005. Due to our acquisition of oritavancin in December 2005, we incurred several expenses in 2006 that we did not incur prior to that acquisition, including $2.5 million for research contracts expense, comprised of $1.4 million in amounts paid to manage our clinical database work done in preparation for the NDA submission for oritavancin, $900,000 in amounts paid for third party product manufacturing and validation work in preparation for the commercial launch of oritavancin, and $216,000 in amounts paid for third party pre-clinical work for the osteomyelitis program. Further, the increase during fiscal 2006 in research and development expense was attributable to: an increase of $2.0 million in salaries and benefits expenses, which increased from $2.2 million to $4.2 million mainly due to the hiring of 28 development employees related to the oritavancin program and partially offset by a decrease of 9 research employees; an increase of $1.3 million in consultant costs, which increased from $154,000 to $1.5 million, primarily related to preparation for the oritavancin NDA submission; an increase of $445,000 in laboratory supply costs, comprised of non-capital consumable and durable goods used in research activities (e.g. reagents, laboratory glassware, chemicals and solutions), which increased from $911,000 to $1.4 million, mainly due to increased costs for testing of oritavancin, partially offset by a decrease in laboratory supply expense resulting from a decrease in the number of full-time laboratory staff.

 

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General and administrative expense . General and administrative expense during the fiscal years ended May 31, 2005 and December 31, 2006 was as follows:

 

     Year ended    Change  
     May 31,
2005
   December 31,
2006
   $    %  
     ($ in thousands)  

General and administrative

   $ 1,388    $ 3,352    $ 1,964    141.5 %

General and administrative expense for the fiscal year ended December 31, 2006 was $3.4 million, compared to $1.4 million for the fiscal year ended May 31, 2005. The increase in general and administrative expense in fiscal 2006 was primarily the result of a $943,000 increase in amounts paid for legal, accounting and consulting fees, which increased from $187,000 to $1.1 million; an increase of $286,000 in amounts paid for recruiting fees, which increased from $76,000 to $362,000, due to the recruitment of our Chief Executive Officer and Chief Financial Officer and the initiation of our search for a Chief Commercial Officer; an increase of $226,000 in amounts paid for salary and benefit expenses associated with the hiring of additional administrative staff (including our Chief Executive Officer and our Chief Financial Officer), which increased from $539,000 to $765,000; and an increase of $195,000 in amounts paid for marketing expenses, which increased from $95,000 to $290,000 primarily due to market research related to oritavancin.

Interest income. Interest income for the years ended May 31, 2005 and December 31, 2006 was as follows:

 

     Year ended    Change  
     May 31,
2005
   December 31,
2006
   $    %  
     ($ in thousands)  

Interest income

   $ 78    $ 280    $ 202    259.0 %

Interest income for the fiscal year ended December 31, 2006 was $280,000, compared to $78,000 for the fiscal year ended May 31, 2005. The increase in interest income from 2005 to 2006 was due primarily to higher average cash and cash equivalent balances during 2006, due to the receipt of approximately $11.8 million of net proceeds from our October and December 2005 convertible note financings, as well as a slight increase in interest rates.

Interest expense. Interest expense for the fiscal years ended May 31, 2005 and December 31, 2006 was as follows:

 

     Year ended     Change
     May 31,
2005
    December 31,
2006
    $     %
     ($ in thousands)

Interest expense

   $ (211 )   $ (14,968 )   $ (14,757 )   N.M.

Interest expense for the fiscal year ended December 31, 2006 was $15.0 million, compared to $211,000 for the fiscal year ended May 31, 2005. The increase in interest expense from 2005 to 2006 was primarily due to an increase of $12.5 million in debt discount amortization associated with the issuance of warrants and the beneficial conversion feature associated with the convertible notes, $1.0 million of interest expense in connection with the convertible notes issued in October and December 2005, including the convertible note issued to InterMune in December 2005, an increase of $898,000 of interest expense on the Investissement Québec (or IQ) loan due to an increase in the note payable balance, an increase in the fair value of the warrants issued to IQ, as well as an increase of $326,000 in the amortization of deferred financing costs.

Income tax benefit (expense). Income tax benefit (expense) for the fiscal years ended May 31, 2005 and December 31, 2006 was as follows:

 

     Year ended     Change  
     May 31,
2005
   December 31,
2006
    $     %  
     ($ in thousands)  

Income tax benefit (expense)

   $ 759    $ (431 )   $ (1,190 )   (156.8 )%

 

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Income tax expense for the year ended December 31, 2006 was $431,000, compared to a $759,000 income tax benefit for the year ended May 31, 2005. The decrease in income tax benefit from 2005 to 2006 was due to lower qualifying research and development expenses, as well as an increase of $210,000 in the Part VI.I income tax expense, which increased from $605,000 to $815,000.

Year ended May 31, 2005 compared to year ended May 31, 2004

Revenue.  We recorded no revenue in the fiscal years ended May 31, 2004 or 2005.

Research and development expense . Research and development expense during the fiscal years ended May 31, 2004 and 2005 was as follows:

 

     Year ended May 31,    Change  
         2004            2005            $             %      
     ($ in thousands)  

Research and development

   $ 5,198    $ 4,503    $ (695 )   (13.4 )%

Research and development expense for the fiscal year ended May 31, 2005 was $4.5 million, compared to $5.2 million for the fiscal year ended May 31, 2004. The decrease during fiscal 2005 in research and development expense was primarily the result of a $710,000 decrease in laboratory supply costs, which decreased from $1.6 million to $911,000, primarily as a result of an expenditure of $650,000 in 2004 for a chemistry compound library; a decrease of $104,000 in research contract expense, which decreased from $105,000 to $1,000 due to a phage research program expense of $104,000 in 2004; a decrease of $45,000 in salaries and benefits expenses, which decreased from $2.3 million to $2.2 million; partially offset by a $146,000 increase in rent expense, which increased from $281,000 to $427,000 due to the expansion of our chemistry and in vivo laboratory space.

General and administrative expense . General and administrative expenses during the fiscal years ended May 31, 2004 and 2005 was as follows:

 

     Year ended May 31,    Change  
         2004            2005            $             %      
     ($ in thousands)  

General and administrative

   $ 1,506    $ 1,388    $ (118 )   (7.8 )%

General and administrative expense for the year ended May 31, 2005 was $1.4 million, compared to $1.5 million for the year ended May 31, 2004. The decrease during fiscal 2005 in general and administrative expense was primarily the result of a $141,000 decrease in salary and benefit expenses, which decreased from $680,000 to $539,000 primarily related to the elimination of the Director of Business Development position; and a $120,000 decrease in professional services fees, which decreased from $307,000 to $187,000 due primarily to fees incurred in 2004 related to capital restructuring consultants and legal fees related to potential financing; partially offset by a $52,000 increase in marketing expenses, which increased from $43,000 to $95,000 as a result of a commissioned research study on the osteomyelitis market.

Interest income. Interest income for the fiscal years ended May 31, 2004 and 2005 was as follows:

 

     Year ended May 31,    Change  
         2004            2005            $             %      
     ($ in thousands)  

Interest income

   $ 125    $ 78    $ (47 )   (37.6 )%

Interest income for the fiscal year ended May 31, 2005 was $78,000, compared to $125,000 for the fiscal year ended May 31, 2004. The decrease in interest income during fiscal 2005 was due to lower average cash and cash equivalent balances during 2005.

 

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Interest expense. Interest expense for the fiscal years ended May 31, 2004 and 2005 was as follows:

 

     Year ended May 31,     Change  
         2004             2005             $             %      
     ($ in thousands)  

Interest expense

   $ (41 )   $ (211 )   $ (170 )   (414.6 )%

Interest expense for the year ended May 31, 2005 was $211,000, compared to $41,000 for the year ended May 31, 2004. The increase in interest expense in fiscal 2005 was primarily due to an increase of $151,000 in interest related to the IQ loan and an increase of $35,000 in amortization of deferred financing costs related to this loan.

Income tax benefit. Income tax benefit for the fiscal years ended May 31, 2004 and 2005 was as follows:

 

     Year ended May 31,    Change  
         2004            2005            $             %      
     ($ in thousands)  

Income tax benefit

   $ 776    $ 759    $ (17 )   (2.2 )%

Income tax benefit for the fiscal year ended May 31, 2005 was $759,000, compared to $776,000 for the fiscal year ended May 31, 2004. The decrease in fiscal 2005 was due to lower qualifying research and development expenses in 2005 compared to 2004, partially offset by a decrease in the Part VI.I income tax expense.

Seven months ended December 31, 2005 compared to seven months ended December 31, 2004 (unaudited)

Revenue . We recorded no revenue during the seven months ended December 31, 2004 or 2005.

Research and development expense . Research and development expense during the seven months ended December 31, 2004 and 2005 was as follows:

 

     Seven months ended December 31,    Change  
         2004            2005            $             %      
     ($ in thousands)  

Research and development

   $ 2,682    $ 2,319    $ (363 )   (13.5 )%

Research and development expense for the seven months ended December 31, 2005 was $2.3 million, compared to $2.7 million for the seven months ended December 31, 2004. The decrease during the seven months ended December 31, 2005 in research and development expense was primarily the result of a $303,000 decrease in laboratory supply costs, which decreased from $596,000 to $293,000 primarily as a result of an expenditure in 2004 for a chemistry compound library; a $244,000 decrease in salaries and benefits expenses, which decreased from $1.3 million to $1.1 million primarily due to a decrease of 9 research employees; partially offset by a $113,000 increase in rent expense, which increased from $196,000 to $309,000 due to the expansion of our chemistry and in vivo laboratory space.

Acquired in-process research and development expenses. Acquired in-process research and development expense during the seven months ended December 31, 2004 and 2005 was as follows:

 

     Seven months ended December 31    Change  
         2004            2005            $            %      
     ($ in thousands)  

Acquired in-process research and development

   —      $ 11,847    $ 11,847    100 %

Acquired in-process research and development expense for the seven months ended December 31, 2005 increased $11.8 million as a result of the acquisition of the oritavancin asset. For the seven months ended December 31, 2004 our acquired in-process research and development expense was zero.

 

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General and administrative expense . General and administrative expense during the seven months ended December 31, 2004 and 2005 was as follows:

 

     Seven months ended December 31,    Change  
         2004            2005            $            %      
     ($ in thousands)  

General and administrative

   $ 737    $ 2,108    $ 1,371    186.0 %

General and administrative expense for the seven months ended December 31, 2005 was $2.1 million, a $1.4 million increase as compared to $737,000 for the seven months ended December 31, 2004. The increase during the seven months ended December 31, 2005 in general and administrative expense was primarily the result of a $1.2 million increase in professional services fees, which increased from $138,000 to $1.4 million due primarily to fees incurred from diligence and closing activities related to the acquisition of the oritavancin asset, as well as the expense of sustaining the oritavancin patent portfolio; a $57,000 increase in salary and benefit expenses, which increased from $334,000 to $391,000 primarily related to merit pay increases; and a $53,000 increase in marketing expenses, which increased from $1,000 to $54,000 as a result of a commissioned research study on the osteomyelitis market.

Interest income . Interest income for the seven months ended December 31, 2004 and 2005 was as follows:

 

     Seven months ended December 31,    Change  
         2004            2005            $             %      
     ($ in thousands)  

Interest income

   $ 50    $ 31    $ (19 )   (38.0 )%

Interest income for the seven months ended December 31, 2005 was $31,000, compared to $50,000 for the seven months ended December 31, 2004. The decrease in interest income for the seven months ended December 31, 2005 was due to lower average cash and cash equivalent balances during the seven months ended 2005.

Interest expense . Interest expense for the seven months ended December 31, 2004 and 2005 was as follows:

 

     Seven months ended December 31,     Change  
         2004             2005             $             %      
     ($ in thousands)  

Interest expense

   $ (72 )   $ (852 )   $ (780 )   (1083.3 )%

Interest expense for the seven months ended December 31, 2005 was $852,000, compared to $72,000 for the seven months ended December 31, 2004. The increase in interest expense for the seven months ended December 31, 2005 was primarily due to an increase of $569,000 in interest expense in connection with convertible notes issued in October and December 2005, including the convertible notes in the amount of $13.0 million issued to InterMune in December 2005, and an increase of $211,000 in interest related to the IQ loan, partially offset by a $12,000 decrease in capital lease expense.

Income tax benefit . Income tax benefit for the seven months ended December 31, 2004 and 2005 was as follows:

 

     Seven months ended December 31,    Change  
         2004            2005            $            %      
     ($ in thousands)  

Income tax benefit

   $ 464    $ 1,491    $ 1,027    221.3 %

Income tax benefit for the seven months ended December 31, 2005 was $1.5 million, compared to $464,000 for the seven months ended December 31, 2004. The increase in income tax recovery for the seven months ended December 31, 2005 resulted from a decrease of $829,000 in the Part VI.I income tax expense, which decreased

 

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from an expense of $353,000 to a credit of $476,000, as well as an assessment provided by the Canadian government that was performed during the seven months ended December 31, 2005 that resulted in additional income tax recovery credits from prior periods being recorded in 2005.

Liquidity and Capital Resources

We have incurred losses since our inception in May 20, 1997 and, as of March 31, 2007, we had a deficit accumulated during the development stage of $82.3 million. We have financed our operations to date primarily through the sale of preferred stock and common stock, debt financings, interest earned on investments and investment tax credits. Through March 31, 2007, we have received aggregate gross proceeds of $105.8 million from financings, of which $70.4 million was from the issuance of preferred stock, $2.7 million was from the issuance of common stock and $32.7 million was from debt financings. Our cash and cash equivalents include amounts held in money market funds and an overnight investment account, stated at cost plus accrued interest, which approximates fair market value. We invest cash in excess of immediate requirements in accordance with our investment policy, primarily to achieve liquidity and capital preservation.

In January and February 2007, we issued an aggregate of 9,776,162 shares of our Series C-1, Series C-2 and Series C-3 convertible preferred stock at a price of $10.45 per share, in consideration of (i) gross proceeds of approximately $58.1 million, (ii) the conversion of previously issued convertible promissory notes in the aggregate amount of $24.6 million, including principal and accrued interest, and (iii) the conversion of $17.5 million of convertible notes payable to InterMune. We issued 8,350,539 of those shares at an initial closing on January 31, 2007 and 708,028 shares at a second closing on February 16, 2007. We issued the remaining 717,595 shares on February 7, 2007 in accordance with the achievement of the first InterMune milestone. We also issued warrants exercisable in the aggregate (on an as-exchanged basis) for 484,354 shares of Series C-1 Preferred Stock and 29,855 shares of common stock in connection with these share issuances. After giving effect to this financing, as of December 31, 2006, on a pro forma basis, our cash, cash equivalents and short-term investments and our long-term debt would have been $70.9 million and $7.3 million, respectively.

The following table summarizes our net (decrease) increase in cash and cash equivalents for the fiscal years ended May 31, 2004 and 2005, the seven months ended December 31, 2005 and the fiscal year ended December 31, 2006:

 

     Year ended May 31,    

Seven months ended
December 31,

2005

   

Year ended
December 31,

2006

   

Three
months
ended
March 31,

2006

   

Three
months
ended
March 31,

2007

 
     2004     2005          
     ($ in thousands)     (unaudited)     (unaudited)  

Net cash provided by (used in):

            

Operating activities

   $ (5,122 )   $ (3,161 )   $ (3,805 )   $ (13,022 )   $ (2,826 )   $ (9,974 )

Investing activities

     5,283       (128 )     (7 )     (182 )     (65 )     (110 )

Financing activities

     (377 )     3,799       13,183       13,525       (39 )     55,565  

Net increase (decrease) in cash and cash equivalents

   $ (216 )   $ 510     $ 9,371     $ 321     $ (2,930 )   $ 45,481  

Net cash used in operating activities . Net cash used in operating activities was $2.8 million for the three months ended March 31, 2006, compared to $10.0 million for the three months ended March 31, 2007. This $7.2 million increase in cash used in operations was due primarily to an increase in net loss of $11.7 million, which was a result of the increase in research and development and general and administrative expenditures as described above; a decrease in non-cash interest expense of $2.4 million; an increase in the net changes in working capital items relating to operations of $863,000; partially offset by an increase in non-cash acquired in-process research and development expense of $7.5 million; and an increase in the non-cash amortization of deferred financing costs of $249,000.

 

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Net cash used in operating activities was $3.2 million for the fiscal year ended May 31, 2005, compared to $13.0 million for the fiscal year ended December 31, 2006. This $9.8 million increase in cash used in operations was due primarily to an increase in net loss of $24.9 million which was a result of the increase in research and development and general and administrative expenditures as described above; partially offset by an increase in non-cash interest expense of $14.4 million; partially offset by an increase in the non-cash amortization of deferred financing costs of $326,000; and partially offset by an increase in the net changes in working capital items relating to operations of $179,000.

Net cash used in operating activities was $5.1 million for the fiscal year ended May 31, 2004, compared to $3.2 million for the fiscal year ended May 31, 2005. The $1.9 million decrease from 2005 compared with 2004 in cash used in operations was due primarily to a decrease in the amount needed to fund working capital needs of $1.2 million; a decrease in the net loss of $579,000; an increase in the non-cash interest expense of $186,000; an increase in the non-cash depreciation and amortization expense of $81,000; and an increase in the non-cash stock compensation expense of $31,000.

Net cash used in investing activities . Net cash used in investing activities was $65,000 for the three months ended March 31, 2006, compared to net cash used in investing activities of $110,000 for the three months ended March 31, 2007. The $45,000 increase in cash used was due to a $45,000 increase in cash used in the purchase of property and equipment, a $14,000 increase in the cash used in the purchases of short-term investments and partially offset by $14,000 in proceeds from short-term investments.

Net cash used in investing activities was $128,000 for the fiscal year ended May 31, 2005, compared to net cash used in investing activities of $182,000 for the fiscal year ended December 31, 2006. The $54,000 increase in cash used in fiscal 2006 compared with fiscal 2005 was due to a $54,000 increase in cash used in the purchase of property and equipment; and a $44,000 increase in the cash used in the purchases of short-term investments; offset by a $44,000 increase in proceeds from short-term investments.

Net cash provided by investing activities was $5.3 million for the fiscal year ended May 31, 2004, compared to net cash used in investing activities of $128,000 for the fiscal year ended May 31, 2005. The $5.4 million increase in net cash used was due to a $5.9 million decrease in cash provided by the maturities of short-term investments; partially offset by a $475,000 decrease in the cash used in the purchase of property and equipment; and partially offset by a $25,000 decrease in the cash used in the purchase of short-term investments.

Net cash provided by financing activities . Net cash used by financing activities was $39,000 for the three months ended March 31, 2006, compared to net cash provided by financing activities of $55.6 million for the three months ended March 31, 2007. The $55.6 million increase in net cash provided was due to $57.8 million provided by our series C financing transaction; a decrease of $39,000 in principal payments for capital leases; partially offset by a $2.2 million increase in the payments on convertible notes; and partially offset by an increase of $82,000 in deferred financing costs.

Net cash provided by financing activities was $3.8 million for the fiscal year ended May 31, 2005, compared to net cash provided by financing activities of $13.5 million for the fiscal year ended December 31, 2006. The $9.7 million increase in net cash provided was due to $14.0 million provided by the issuance of convertible debentures for the fiscal year 2006; partially offset by $4.1 million provided by the issuance of notes payable for fiscal year 2005; an increase of $420,000 in deferred financing costs; a decrease of $245,000 of principal payments for capital lease obligations; and a $1,000 decrease in proceeds from the issuance of common stock.

Net cash used in financing activities was $377,000 for the fiscal year ended May 31, 2004, compared to net cash provided by financing activities of $3.8 million for the fiscal year ended May 31, 2005. The $4.2 million increase in net cash provided was due to $4.1 million provided by the issuance of a note payable for fiscal year 2005; a decrease of $60,000 in payments on the note payable; and partially offset by an increase of $11,000 in principal payments for capital lease obligations.

 

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In April 2004, the Company signed a loan agreement with IQ for a loan facility of approximately $6.9 million (CAN$8.0 million) (the “ IQ Loan Facility ”). Interest expense on the IQ Loan Facility was $0 and $151,512 for the fiscal years ended May 31, 2004 and 2005, respectively, $249,235 for the seven months ended December 31, 2005 and $681,461 for the year ended December 31, 2006. We are not obligated to make interest payments on the IQ Loan Facility until August 2007 and have capitalized all interest expense related to the IQ Loan Facility. The IQ loan is repayable annually at a rate of 25% of net income per year over a period not exceeding ten years from the date of the first disbursement, which was August 19, 2004. The interest rate applicable to this loan is IQ’s own prime rate plus 1.5% (which was 8.0% at December 31, 2005 and 9.0% at December 31, 2006). In connection with this loan, we issued IQ a warrant to purchase (on an as-if exchanged basis) up to 6,837 shares of Series B redeemable convertible preferred stock, exercisable for the period from the date of the first disbursement of the funds under this loan facility, or August 19, 2004, through the first anniversary date of our final reimbursement of the IQ Loan Facility, at an exercise price of CAN$234.00 per share (or US$202.67 as of March 31, 2007). To date, IQ has not exercised this warrant. We are required to increase the number of shares into which this warrant is exercisable to reflect any dividends paid on the Series B redeemable convertible preferred stock. As a result of our payment in January 2007 of accrued dividends on the shares of Series B redeemable convertible preferred stock, upon exercise of its warrant, IQ is currently entitled to receive 8,200 shares of Series B redeemable convertible preferred stock (on an as-if exchanged basis).

Funding requirements

To date, we have not commercialized any products and have not achieved profitability. We anticipate that we will continue to incur substantial net losses for the next several years as we further develop and prepare for the commercial launch of oritavancin and develop the corporate infrastructure required to sell our product candidates and operate as a publicly traded company.

We have not generated any product revenue since our inception and do not expect to generate any revenue from the sale of products unless we receive regulatory approval for commercial sale of oritavancin. We believe the net proceeds from this offering, together with our existing cash, cash equivalents and investment balances, and interest income we earn on these balances, will be sufficient to meet our anticipated cash requirements into 2009. It is difficult to predict the actual rate of product sales until the product is approved by the FDA and the specific language allowed by the FDA on the label is known. If our available cash, cash equivalents and investment balances, along with the net proceeds from this offering, are insufficient to satisfy our liquidity requirements, we will seek to sell additional equity or debt securities or enter into another credit facility. The sale of additional equity may result in dilution to our stockholders. If we raise additional funds through the issuance of debt securities, these securities would have rights senior to those of our common stock and could contain covenants that would restrict our operations. We may require additional capital beyond our currently anticipated amounts. Any such required additional capital may not be available on reasonable terms, if at all. If we are unable to obtain additional financing, we may be required to reduce the scope of, delay, or eliminate some or all of, our planned research, development and commercialization activities, which could materially harm our business.

Our forecast of the period of time through which our financial resources will be adequate to support our operations, the costs to obtain regulatory approval, the costs to commercialize oritavancin, and the costs to expand the approved indications for oritavancin beyond our initial indication of cSSSI are forward-looking statements and involve risks and uncertainties, and actual results could vary materially and negatively as a result of a number of factors, including the factors discussed in the “Risk Factors” section of this prospectus. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect.

Due to the numerous risks and uncertainties associated with the development of our product, we are unable to estimate the exact amounts of capital outlays and operating expenditures necessary to complete the development of and to obtain regulatory approval for oritavancin for all of the indications for which we believe oritavancin is suited. Our funding requirements will depend on many factors, including, but not limited to, the following:

 

   

the time and costs involved in obtaining regulatory approvals for our product candidates;

 

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the rate of progress and cost of our commercialization activities;

 

   

the success of our research and development efforts;

 

   

the expenses we incur in marketing and selling our product candidates;

 

   

the revenue generated by sales of our product candidates;

 

   

the emergence of competing or complementary technological developments;

 

   

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

 

   

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

 

   

the acquisition of businesses, products and technologies (although we currently have no commitments or agreements relating to any of these types of transactions).

Contractual obligations

The following table summarizes our outstanding contractual obligations as of December 31, 2006 and the effect these obligations are expected to have on our liquidity and cash flows in future periods:

 

(in thousands)

   Total   

Less than

1 year

   1-3 years    4-5 years   

More than

5 years

Operating lease obligations

   $ 1,322    $ 367    $ 690    $ 265    $ —  

Convertible debt

     38,828      25,828      13,000      —        —  

Note payable(1)

     7,948      —        —        —        7,948

License agreements(2)

     2,225      2,225      —        —        —  
                                  

Total

   $ 50,323      $28,420    $ 13,690    $ 265    $ 7,948
                                  

(1)   The note payable due to IQ is repayable annually at a rate of 25% of net income per year over a period not exceeding ten years from the date of the first disbursement, which was August 19, 2004. On January 30, 2007, we amended our agreement with IQ to change the payment terms so that we must pay all outstanding principal and accrued interest under the note payable by June 30, 2008.
(2)   Includes $225,000 due to ElizaNor Biopharmaceuticals, Inc. (but excludes $20,000 in related interest expense) and $2,000,000 due to InterMune, Inc. upon our receipt of authorization from the FDA to conduct clinical studies, both of which amounts were paid by February 2007.

The table above reflects only payment obligations that are fixed and determinable and does not include possible contingent payments under license agreements or acquired patents. Our commitments for operating leases relate to the lease for our corporate headquarters in Cambridge, Massachusetts, our development facility in Indianapolis, Indiana and our research facilities in Montreal, Québec, Canada. The amounts shown in the table above as convertible debt represent amounts that were converted into equity securities in connection with our January and February 2007 Series C financing.

In addition to the amounts reflected in the table above, in the future we may owe royalties and other contingent payments to our collaborators, licensors and other parties based on the achievement of product sales and specified other objectives and milestones. For example, our license agreement with Lilly requires us to make milestone payments to Lilly following regulatory approval of oritavancin for indications other than cSSSI, and in connection with our acquisition of the worldwide rights to oritavancin from InterMune in December 2005, we entered into an asset purchase agreement with InterMune pursuant to which we agreed to make future payments related to achieving certain milestones.

Off-balance sheet arrangements

We do not have any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, that would have been established for the purpose of facilitating off-balance sheet arrangements (as that term is defined in Item 303(a)(4)(ii) of

 

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Regulation S-K) or other contractually narrow or limited purposes. As such, we are not exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in those types of relationships.

Tax loss carryforwards

At December 31, 2006, we had United States federal and state net operating loss carryforwards of approximately $10,332,000 and Canadian federal and provincial net operating loss carryforwards of approximately $22,582,000, which loss carryforwards expire at various dates beginning in 2007 through 2026. At December 31, 2006, we had Canadian research and development expenditures of approximately $10,881,000 that had not been deducted for Canadian federal income tax purposes and approximately $20,805,000 that had not been deducted for Canadian provincial tax purposes. These expenditures are available to reduce future taxable income and have an unlimited carryforward period. Additionally, we have United States federal research and development tax credits of approximately $607,000 and Canadian research and development tax credits of approximately $1,398,000, that expire at various dates ranging from 2007 through 2026. Section 382 of the Internal Revenue Code limits the annual utilization of net operating loss and tax credit carryforwards following an ownership change in our company. We believe that, with our initial public offering, our most recent private placement and other transactions that have occurred over the past three years, we have triggered an “ownership change” limitation.

Critical accounting policies and estimates

Our discussion and analysis of our financial condition and results of operations are based on our consolidated 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 judgments that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements as well as the reported revenues and expenses during the reporting periods. On an ongoing basis, we evaluate our estimates and judgments, including those related to stock-based compensation. We base our estimates on historical experience, known trends and events and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

While our significant accounting policies are described in more detail in Note 2 of the notes to our consolidated financial statements appearing elsewhere in this prospectus, we believe the following accounting policy to be critical to the judgments and estimates used in the preparation of our consolidated financial statements.

Stock-based compensation

From our inception and prior to January 1, 2006, we accounted for our stock-based awards to employees in accordance with the provisions of SFAS No. 123, Accounting for Stock-Based Compensation (“ SFAS No. 123 ”), which required that stock-based compensation cost be measured at the grant date based on the fair value of the award and be recognized as expense over the vesting period.

Effective January 1, 2006, we adopted the fair value recognition provisions of SFAS No. 123(R), Shared Based Payment (“ SFAS No. 123(R) ”), using the modified prospective transition method. Under the modified prospective transition method, compensation cost recognized in the year ended December 31, 2006 included: (a) the compensation cost for all share-based compensation granted prior to, but not yet vested as of December 31, 2005, based on the grant-date fair value, estimated in accordance with the original provisions of SFAS No. 123; and (b) the compensation cost for all share-based payments granted on or subsequent to January 1, 2006, based on the grant-date fair value, estimated in accordance with the provisions of SFAS No. 123(R). In accordance with the modified prospective transition method of SFAS No. 123(R), results for prior periods have not been restated. The impact of adopting SFAS No. 123(R) was not material to our net loss or cash flows. For all grants, we adjusted the amount of stock-based compensation expense recognized for estimated

 

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forfeitures of awards for which the requisite service was not expected to be provided. Estimated forfeiture rates are developed based on our analysis of comparable companies’ forfeiture data. Prior to our adoption of the fair value recognition provisions of SFAS No. 123(R), we adjusted stock-based payment expense for actual forfeitures as they occurred. The cumulative effect of this change in accounting treatment for forfeitures was not material to our consolidated financial statements.

We account for stock-based compensation expense for non-employees in accordance with SFAS No. 123(R) and Emerging Issues Task Force (“ EITF ”) Issue No. 96-18, Accounting for Equity Instruments that are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling Goods and Services . We record the expense of services rendered by non-employees based on the estimated fair value of the stock option using the Black-Scholes option-pricing model. Further, we expense the fair value of non-employee stock options over the vesting term of the underlying stock options.

For stock-based compensation awards granted to both employees and non-employees, we use the fair value method of calculating stock-based compensation in accordance with SFAS No. 123 for awards prior to January 1, 2006 and SFAS No. 123(R) for awards on or after January 1, 2006. Calculating the fair value of stock-based awards requires that we make highly subjective assumptions. We use the Black-Scholes option pricing model to value our stock option awards. Stock-based compensation expense is significant to our financial statements and is calculated using our best estimates, which involve inherent uncertainties and the application of management’s judgment. Significant estimates in this calculation include the expected life of the stock option, stock price volatility, risk-free interest rate and forfeiture rates.

As there has been no public market for our common stock prior to this offering, we have determined the volatility for stock options granted in 2006 and 2007 based on an analysis of reported data for a peer group of companies with sufficient trading history, similar vesting provisions and a similar percentage of stock options that were in-the-money during 2006 and 2007. We determined the expected volatility of options granted during 2006 and 2007 to be 67.2% and 64.1% by using an average of the historical volatilities of this peer group of companies for a period equal to the expected term of the option. We determined the expected term of options granted in 2006 and 2007 to be 5.3 years and 5.4 years by using an average of the reported expected term of this peer group of companies. We applied a weighted-average risk free interest rate of 4.68% for the 2006 grants and 4.50% for the 2007 grants, based on a zero coupon United States treasury instrument whose term is consistent with the expected term of the stock options. We have not paid and do not anticipate paying cash dividends on our shares of common stock; therefore, the expected dividend yield is assumed to be zero. In addition, SFAS No. 123(R) requires companies to utilize an estimated forfeiture rate when calculating the expense for the period, whereas SFAS No. 123 permitted companies to record forfeitures based on actual forfeitures, which was our historical policy under SFAS No. 123. Since our historical forfeiture experience was not sufficient to predict future forfeitures in light of our cancellation and granting of replacement stock options in 2003, in our consolidated statement of operations, we applied an estimated forfeiture rate of 5.00% based on the forfeiture rates of the selected peer companies. We expect these assumptions to change in the future as our peer companies experience changes in assumptions and as we begin to develop our own assumptions to be used in the Black-Scholes option pricing model. These changes in assumptions, as well as changes in the amount and exercise price of stock options granted in future periods, will change the amount of stock-based compensation expense that we record under SFAS No. 123(R) in future periods.

We have historically granted stock options at exercise prices not less than the fair market value of our common stock as determined by our board of directors, with input from management. Our board of directors has historically determined, with input from management, the estimated fair market value of our common stock on the date of grant based on a number of objective and subjective factors, including external market conditions affecting the biotechnology industry sector and the prices at which we sold shares of convertible and redeemable convertible preferred stock, the superior rights and preferences of securities senior to our common stock at the time of each grant and the likelihood of achieving a liquidity event such as an initial public offering or sale of our company.

 

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The following table presents the grant dates and related exercise prices of stock options granted to employees and other equity issuances made since January 1, 2006:

 

Date of
Issuance

 

Nature of
Issuance

  Number
of Shares
 

Exercise

or

Purchase
Price per
Share

 

Determination of Price

 

Related Party Status

  Grant Date
Fair Value (1)
 

Stock-Based

Compensation
(2)

March 29, 2006   Option Grant   11,579   $36.00-
$48.63
  Determined by the Board of Directors in accordance with the procedures and considerations set forth herein.   Employees, officers and directors of the Company   $1.50   $16,562
July 13, 2006   Option Grant   4,263   $36.00   Determined by the Board of Directors in accordance with the procedures and considerations set forth herein.  

Employees and officers

of the Company

  $1.50   $6,385
October 17, 2006   Option Grant   13,832   $70.50   Determined by the Board of Directors in accordance with the procedures and considerations set forth herein.  

Officers of the Company

  $1.50   $20,750

November 10, 2006

  Option Grant   3,055   $70.50   Determined by the Board of Directors in accordance with the procedures and considerations set forth herein.  

Employees

and officers

of the Company

  $1.50   $4,558
January 31, 2007   Series C preferred stock financing (initial closing)   8,350,539   $10.45157   Determined as a result of arms-length negotiations with the three new lead investors in the Series C financing.   New and existing investors in the Company. (See “Certain Relationships and Related Party Transactions” for a further discussion of purchases made by related parties.)   Not
Applicable
  Not
Applicable
January 31, 2007   Warrant Issuance (exercisable for shares of Series C-1 preferred stock)   413,723   $13.06   Determined as part of the Series C financing, which was the result of arms-length negotiations with three new lead investors.   New and existing investors in the Company. (See “Certain Relationships and Related Party Transactions” for a further discussion of warrants issued to related parties.)   Not
Applicable
  Not
Applicable

 

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Date of
Issuance

 

Nature of
Issuance

  Number
of Shares
 

Exercise

or

Purchase
Price per
Share

 

Determination of Price

 

Related Party Status

 

Grant Date
Fair Value (1)

 

Stock-Based

Compensation
(2)

January 31, 2007   Stock Dividend (paid in shares of Series B preferred stock)   26,691   N/A   Calculated in accordance with the accrued dividend provisions of the Company’s certificate of incorporation as in effect prior to the Series C financing.   All current holders of Series B preferred stock. Issued in connection with the termination of that accruing dividend as payment of the dividend accrued on such shares through the payment date. The determination to make this payment was part of the negotiation of the Series C financing.   Not
Applicable
  Not
Applicable
January 31, 2007   Warrant Issuance (exercisable for shares of common stock)   29,855   $10.45157   Determined as part of the Series C financing, which was the result of arms-length negotiations with three new lead investors.   Issued in connection with the Series C financing to holders of the Company’s outstanding shares of common stock, which holders are primarily former employees of the Company. (See “Certain Relationships and Related Party Transactions” for a further discussion of the issuance of a common stock warrant to one related party.)   Not
Applicable
  Not
Applicable

 

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Date of
Issuance

 

Nature of
Issuance

  Number
of Shares
 

Exercise

or

Purchase
Price per
Share

 

Determination of Price

 

Related Party Status

 

Grant Date
Fair Value (1)

 

Stock-Based

Compensation
(2)

February 7, 2007

  Conversion of Convertible Note (issued on December 23, 2005) for shares of Series C preferred stock   717,595   N/A   Shares were issued per the terms of a convertible promissory note issued by the Company to InterMune in connection with the Company’s acquisition of oritavancin on December 23, 2005, which note was amended on January 31, 2007.   InterMune was not a related party at the time it received this convertible promissory note, but was a related party at the time of conversion of this note. The Company issued these shares in connection with its achievement of a milestone under this convertible promissory note.   Not
Applicable
  Not
Applicable
February 7, 2007   Warrant Issuance (issued in connection with conversion of a convertible promissory note and exercisable for shares of Series C-1 preferred stock)   35,552   $13.06   Determined as a result of arms-length negotiations with the three new lead investors in the Series C financing.   Issued in connection with the issuance of the shares of Series C preferred stock noted above in connection with the Company’s achievement of a milestone. The number of shares for which this warrant is exercisable corresponds to the ratio of warrant coverage for all other recipients of warrants issued in the Series C financing.   Not
Applicable
  Not
Applicable

 

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Date of
Issuance

 

Nature of
Issuance

  Number
of Shares
 

Exercise

or

Purchase
Price per
Share

 

Determination of Price

 

Related Party Status

 

Grant Date
Fair Value (1)

 

Stock-Based

Compensation
(2)

February 16, 2007   Series C preferred stock financing (second closing)   708,828   $10.45157   Shares issued at the second closing of the Company’s Series C financing, which transaction was the result of arms-length negotiations with the three new lead investors.   New investors in the Company and certain investors who participated in the initial closing of the Series C financing, some of whom were related parties at the time of this purchase. (See “Certain Relationships and Related Party Transactions” for a further discussion of purchases made by related parties.)   Not
Applicable
  Not
Applicable
February 16, 2007   Warrant Issuance (exercisable for shares of Series C-1 preferred stock)   35,079   $13.06   Warrants issued at the second closing of the Company’s Series C financing, which transaction was the result of arms-length negotiations with the three new lead investors.   New investors in the Company and certain investors who participated in the initial closing of the Series C financing, some of whom were related parties at the time of this purchase. (See “Certain Relationships and Related Party Transactions” for a further discussion of warrants issued to related parties.)   Not
Applicable
  Not
Applicable
May 8, 2007   Option Grant   1,771,850   $5.00   Determined by the Board of Directors in accordance with the procedures and considerations set forth herein.   Employees, officers and directors of the Company   $2.96   $5,244,579

 

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Date of Issuance

 

Nature of
Issuance

  Number
of Shares
 

Exercise

or

Purchase
Price per
Share

 

Determination of Price

 

Related Party Status

 

Grant Date
Fair Value (1)

 

Stock-Based

Compensation
(2)

May 15, 2007

  Option Grant   25,000   $5.00   Determined by the Board of Directors in accordance with the procedures and considerations set forth herein.  

Director of

the Company

  $2.90   $72,570

(1)   Our estimate of the grant date fair value for stock option grants was computed based upon the Black-Scholes option-pricing model with the assumptions disclosed in Notes 14 and 19 to the consolidated financial statements. The fair market value of our common stock assumption used in the Black-Scholes option-pricing model was derived from retrospective valuations of our common stock as of January 1, 2006, September 30, 2006 and May 31, 2007, as discussed in the pages that follow.
(2)   Amount represents the estimate of the total grant date fair value of stock options granted which is recognized over the requisite service period, net of an estimate of forfeitures.

We did not record any interest expense in connection with the above transactions, other than interest expense incurred on the convertible note issued to InterMune on December 23, 2005.

In connection with the preparation of the consolidated financial statements for the year ended December 31, 2006 and in preparing for this initial public offering (“ IPO ”), we performed retrospective valuations of our common stock as of January 1, 2006 and September 30, 2006. The valuation methodologies used in the retrospective valuations are consistent with the American Institute of Certified Public Accountant’s Technical Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation (the “ Practice Aid ”). We believe that the preparation of the retrospective valuations was necessary due to the fact that the timeframe for a potential IPO had accelerated significantly since the time our board of directors set the exercise prices for recent stock option grants.

In each of the retrospective valuations, we used the Market Approach to estimate the aggregate future enterprise value of our company under an IPO scenario, sale scenario and dissolution scenario.

In applying the Market Approach in the IPO scenario, we used the Guideline Public Company Method as described in the Practice Aid. Under this method, we identified seven comparable publicly traded biotechnology companies (the “ Guideline Companies ”) that either (1) are focused on the development of antiinfectives, (2) currently have one primary marketed product, or (3) are currently developing a Phase 3 clinical trial drug candidate. We used the average of the Guideline Companies’ trailing twelve-month revenues to estimate twelve additional months of revenue and the enterprise values as of the valuation dates, and then computed the enterprise value-to-revenue multiples for each Guideline Company. We then applied the average enterprise value-to-revenue multiple to our estimated 2008 revenues (our estimate of the date of our first commercial revenues) to estimate the future enterprise value of our company. We used this value as the enterprise value in the IPO scenario of the Probability Weighted Expected Return Method.

In applying the Market Approach in the sale scenario, we analyzed sale transactions of similar biotechnology companies. The value used was supported by published transaction values of companies with product candidates in similar stages of development as we estimate our product candidate, oritavancin, would be at December 2007, the estimated date a sale or merger would be consummated.

In applying the market approach in the dissolution scenario, we assumed a sale of our company’s existing research and intellectual property at a value that would not allow our preferred stockholders to realize their liquidation preference.

 

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In order to allocate the enterprise values to the common stock, we used the Probability Weighted Expected Return Method described in the Practice Aid. Under this method, the value of our common stock is estimated based upon an analysis of future values for our company assuming various future outcomes, the timing of which is based on the plans of our board of directors and management. Under this approach, share value is based on the probability-weighted present value of expected future investment returns, considering each of the possible outcomes available to us, as well as the rights of each share class. We estimated the fair market value of our common stock using a probability-weighted analysis of the present value of the returns afforded to our shareholders under each of three possible future scenarios. Two of the scenarios assumed a shareholder exit, either through an IPO or a sale of our company. The third scenario assumed a liquidation or dissolution of our company at a value that is less than the cumulative amounts invested by our preferred shareholders. For the IPO and sale scenarios, the estimated future and present values of our common stock were calculated using assumptions including: the expected pre-money or sale valuations based on the Market Approach (as discussed above), the expected dates of the future expected IPO or sale, and an appropriate risk-adjusted discount rate. For the dissolution or liquidation scenario, the estimated future and present values of our common stock were calculated using assumptions including: the aggregate enterprise value that could be attained through such a sale (as discussed above), the expected date of the future dissolution and an appropriate risk-adjusted discount rate. Finally, the present value calculated for our common stock under each scenario was probability weighted based on our estimate of the relative occurrence of each scenario.

In the retrospective valuations for January and September 2006, our assumptions for the three potential future outcomes were as follows: (i) we become a public company in May 2007 (“ IPO Scenario ”), (ii) we are acquired in December 2007 for a premium (“ Sale Scenario ”), and (iii) we are acquired in December 2007 for less than the liquidation value of preferred stock (“ Dissolution Scenario ”).

We used a 35% probability weight for the IPO Scenario in our January 2006 retrospective valuation and increased this percentage to 40% in the September 2006 retrospective valuation as we achieved significant business milestones, as coverage of our company increased, as we progressed in our meetings with the FDA in 2006 and as our discussions with institutional investors increased in late 2006. This increase in the probability weight assigned to the IPO Scenario caused the value ascribed to our common stock to increase.

In connection with the May 2007 stock option grant, we completed a retrospective valuation as of May 31, 2007. Our assumptions for the four potential future outcomes were as follows: (i) we become a public company in September 2007 (“IPO Scenario”), (ii) we are acquired in September 2007 (“Early Sale Scenario”), (iii) we are unable to achieve liquidity in September 2007 and we are acquired in December 2008 without raising additional capital (“Later Sale Scenario”), and (iv) we are acquired in December 2008 for less than the liquidation value of preferred stock (“Dissolution Scenario”).

In our September 2006 retrospective valuation, we used a 40% probability weight for a liquidity event to occur in 2007 and we increased this percentage for a September 2007 liquidity event to 85% in the May 2007 retrospective valuation as we achieved significant business milestones, as we had filed an initial registration statement on Form S-1 with the SEC, and as we may consider a dual track sale strategy. We estimated that the probability of going public in September 2007 was equal to the probability of being acquired in September 2007 and, therefore, assumed the IPO Scenario and the Early Sale Scenario to each have a probability weighting of 42.5%. This increase in the combined probability weight of a liquidity event in 2007 to 85% caused the value ascribed to our common stock to decrease compared to the September 2006 retrospective valuation. The primary reason for the increased likelihood of a liquidity event in 2007 is the increased likelihood of an Early Sale Scenario in which the liquidation preference payable to the holders of shares of our preferred stock would be greater than in the IPO scenario. This has the effect of reducing the amount of proceeds available to the holders of our common stock.

Under the IPO Scenario, the fair value of our common stock was calculated using the expected aggregate enterprise valuations and a risk-adjusted discount rate of 16% based on the estimated timing of a potential initial public offering with no lack of marketability discount. The risk-adjusted discount rate was based on the inherent

 

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risk of a hypothetical investment in our common stock. An appropriate rate of return required by a hypothetical investor was determined based on our calculated cost of capital. Our calculated cost of capital was developed based upon a quantitative and qualitative analysis of factors that would impact the discount rate.

The fair value of our common stock under the Sale Scenario was determined by reducing the total estimated enterprise value by the liquidation preferences of those preferred shares that would receive more value based on their liquidation preference as opposed to converting to common stock and in the Dissolution Scenario was determined by reducing the total estimated enterprise value by the liquidation preferences of the Series A convertible preferred stock and the Series B redeemable convertible preferred stock. In these scenarios, the total estimated enterprise value was reduced by the repayment of the outstanding debt.

The estimated fair market value of our common stock at each valuation date is equal to the sum of the probability weighted present values for each scenario. We incorporated the fair values calculated in the retrospective valuations into the Black-Scholes option pricing model when calculating the stock-based compensation expense to be recognized for the stock options granted. The retrospective valuations generated per share fair values of our common stock of $4.53, $5.76, and $4.89 for January 2006, September 2006, and May 2007, respectively. Since the exercise prices of our stock options were in excess of the fair value of our common stock derived from the retrospective valuations, there was no intrinsic value at either valuation date.

Valuation models require the input of highly subjective assumptions. Because our common stock has characteristics significantly different from that of publicly traded common stock and because changes in the subjective input assumptions can materially affect the fair value estimate, in management’s opinion, the existing models do not necessarily provide a reliable, single measure of the fair value of our common stock. The foregoing valuation methodologies are not the only valuation methodologies available and will not be used to value our common stock once this offering is complete. We cannot make assurances of any particular valuation of our stock. Accordingly, investors are cautioned not to place undue reliance on the foregoing valuation methodologies as an indicator of future stock prices.

In conjunction with each of the factors noted above, the primary factors contributing to the difference between the fair value of our common stock as of each grant date shown above and the initial public offering price of $             per share include:

 

   

the probability weighting of being able to proceed with an IPO based on achieving business milestones and progress in our meetings with the FDA;

 

   

the passage of time between grant dates, which led to the shifting of the time periods that such valuations are based upon;

   

the closing of our Series C financing transaction in January and February 2007; and

 

   

the achievement of certain business milestones, progress relating to our interactions with the FDA, and progress relating to the filing of our NDA for oritavancin;

 

   

Theravance’s announcement that the FDA will provide a standard review for its NDA application of televancin rather than our original estimate for priority review; and

 

   

recent animal model results in April 2007 contradicting earlier results associated with oritavancin’s effectiveness in pneumonia.

The decrease in the per share fair value of our common stock from $5.76 in September 2006 to $4.89 in May 2007 was primarily attributable to an extension in our schedule for filing an NDA with the FDA, the increased likelihood of a sale of the Company and less favorable than anticipated pneumonia results for oritavancin.

Recently issued accounting pronouncements

In July 2006, the Financial Accounting Standards Board (“ FASB ”) issued Interpretation No. 48, (“ FIN 48 ”), Accounting for Uncertainty in Income Taxes—an interpretation of FASB Statement No. 109 . FIN 48 clarifies the recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax

 

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position taken or expected to be taken in a tax return. FIN 48 also provides guidance on recognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. FIN 48 is effective for fiscal years beginning after December 15, 2006. The adoption of FIN 48 did not have a material effect on the Company’s financial position or results of operations.

In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements , which defines fair value, establishes a framework for measuring fair value under GAAP and expands disclosures about fair value measurements. SFAS No. 157 applies to other accounting pronouncements that require or permit fair value measurements. The new guidance is effective for financial statements issued for fiscal years beginning after November 15, 2007, and for interim periods within those fiscal years. We are currently evaluating the requirements of SFAS No. 157; however, we do not believe that the adoption of SFAS 157 will have a material effect on our consolidated financial statements.

Qualitative and quantitative disclosures about market risk

We are exposed to market risk related to changes in interest rates. As of December 31, 2006, we had cash and cash equivalents and short-term investments of approximately $12.5 million, consisting of cash and highly liquid short-term investments. The goals of our investment policy are preservation of capital, fulfillment of liquidity needs and fiduciary control of cash and investments. We also seek to maximize income from our investments without assuming significant risk. Our primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of interest rates, particularly because our investments are in short-term marketable securities. Due to the short-term duration of our investment portfolio and the low risk profile of our investments, an immediate 10% change in interest rates would not have a material effect on the fair market value of our portfolio. Accordingly, we would not expect our operating results or cash flows to be affected to any significant degree by the effect of a sudden change in market interest rates on our securities portfolio.

As of December 31, 2006, the fair value of our convertible notes approximates their carrying value. The interest rates on our convertible notes are fixed and therefore not subject to interest rate risk. The interest rate on the IQ Loan Facility is IQ’s own prime rate plus 1.5%, which was 8.0% at December 31, 2005 and 9.0% at December 31, 2006 and March 31, 2007. Due to the variable interest rate associated with the IQ Loan Facility, our interest expense is sensitive to changes in the general level of market interest rates in Canada. However, based on the nature and current level of indebtedness under the IQ Loan Facility, we believe that there is no material risk of interest rate exposure.

As of December 31, 2006 and March 31, 2007, we did not have any financing arrangements that were not reflected in our balance sheet.

 

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BUSINESS

Our Company

We are a biopharmaceutical company focused on the development and commercialization of innovative antibiotics for serious infections treated or acquired in hospitals and other institutional settings. We are developing oritavancin, a novel intravenous antibiotic, for the treatment of serious gram-positive bacterial infections, including cSSSI and bacteremia, an infection caused by bacteria in the bloodstream. Gram-positive bacteria have evolved into strains that are highly resistant to many currently available antibiotics, creating an ever-evolving need for novel antibiotics that employ different mechanisms to control them. According to IMS Health, antibiotics designed to treat serious infections caused by resistant gram-positive bacteria accounted for approximately $945 million in United States sales in 2006 and this market is rapidly growing.

We expect to submit an NDA to the FDA seeking to commercialize oritavancin for the treatment of cSSSI in the first quarter of 2008 and hope to receive FDA regulatory approval in late 2008 in the United States and thereafter receive regulatory approvals in Europe. We plan on commercializing oritavancin through our own direct sales force in the United States and in select other countries, and to out-license oritavancin to, or collaborate with, third parties in other countries as we deem appropriate. In addition to oritavancin, we have discovered another antibiotic that is currently in pre-clinical development for the treatment of osteomyelitis, and we continually evaluate opportunities for potential in-licensing of other antibiotics for the treatment of hospital-based infections.

We acquired worldwide rights to oritavancin from InterMune, Inc. in late 2005, and believe that, since then, we have greatly improved its commercial and economic prospects by resolving several important issues with the FDA and by substantially lowering the royalty rate that may be payable to Lilly, the original discoverer of oritavancin. Our strategy is to capitalize on the unique attributes of oritavancin to develop it into a leading therapy worldwide for the treatment of serious gram-positive infections, initially for cSSSI and subsequently for other indications.

Our Lead Product: Oritavancin

Oritavancin is a novel semi-synthetic glycopeptide antibiotic for the treatment of serious gram-positive infections. Oritavancin has completed two Phase 3 studies for the treatment of cSSSI in which the primary endpoints were successfully met. In addition, oritavancin completed two Phase 2 trials for the treatment of bacteremia with successful outcomes. Oritavancin is synthetically modified from a naturally occurring compound, and was originally discovered and developed by Lilly to combat a broad spectrum of gram-positive pathogens in response to the emergence of pathogens resistant to vancomycin, the most commonly prescribed antibiotic for resistant gram-positive infections. Oritavancin is protected by intellectual property rights that we licensed from Lilly. The issued oritavancin patents and pending patent applications are part of an extensive world-wide patent estate that includes a composition of matter patent that runs in the United States through November 24, 2015, and, with the potential for obtaining extension of patent protection available under the Hatch-Waxman Act, we believe may run for up to an additional five years.

As a glycopeptide (which is a short chain of amino acids with attached sugar molecules), oritavancin shares some properties of other members of the glycopeptide class of antibiotics, which includes vancomycin, the current standard of care for serious gram-positive infections in the United States and Europe, as well as telavancin, for which an NDA was submitted in 2006 by Theravance, Inc. However, we believe that oritavancin has advantages compared to other glycopeptides and other classes of gram-positive antibiotics, including the following:

 

   

Rapidly bactericidal and potentially less likely to engender resistance;

 

   

Broad spectrum against gram-positive bacteria;

 

   

Superior in-vitro potency;

 

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Lower incidence of adverse events;

 

   

Favorable elimination profile;

 

   

Long half-life; and

 

   

Potential efficacy in bacteremia.

Oritavancin has been tested in over 1,500 patients and has completed two Phase 3 trials for the indication of cSSSI conducted by Lilly and InterMune. We believe that the completed Phase 3 trials are sufficient for FDA approval of oritavancin for cSSSI due to the following:

 

   

Efficacy. Each Phase 3 clinical trial used a non-inferiority trial design and met the primary endpoint of non-inferiority, which is currently accepted by the FDA as the appropriate trial design for antibiotics that treat serious gram-positive infections. These trials compared oritavancin to an active control arm of vancomycin followed by cephalexin and showed that oritavancin was effective in an average of 5.3 days compared to 10.9 days for vancomycin / cephalexin.

 

   

Safety. In each of these Phase 3 trials, oritavancin was well tolerated and, compared to the control arms, exhibited a favorable safety profile and a lower discontinuation rate due to adverse events.

 

   

Favorable FDA Interactions. The FDA confirmed to us in writing in March 2007 that the non-inferiority design using an active control that was employed in both Phase 3 trials was appropriate for cSSSI. In addition, in three separate meetings, including our pre-NDA meeting on January 31, 2007 in which we specifically discussed the Phase 3 trials, the FDA has not requested that we perform additional clinical trials to demonstrate efficacy in cSSSI. Since the FDA’s accepted delta for non-inferiority trials for antibiotics that treat serious infections like cSSSi (using a comparator like vancomycin) is now 10%, the FDA has requested that we provide justification, as part of our NDA, for the choice of the 15% non-inferiority delta previously accepted by the FDA for the first of these two Phase 3 trials. As part of this analysis, the FDA has requested that we provide information on the non-inferiority margin in terms of both the benefit of oritavancin as compared to historical vancomycin and placebo cure rates and in terms of acceptable loss of treatment effect relative to historical vancomycin and placebo cure rates (in a population as similar as possible to the population enrolled in these Phase 3 clinical trials). The FDA has indicated that this analysis will be critical to approval of our NDA.

As a result, we believe that oritavancin could provide physicians with an efficacious and novel antibiotic for the treatment of serious gram-positive infections while providing significant pharmoeconomic benefits by reducing the need for patient monitoring and shortening hospital stays. We expect that oritavancin will initially be used for patients not improving after treatment of vancomycin, for patients with identified vancomycin-resistant pathogens, or in hospitals or regions where the incidence of pathogens resistant to other drugs is high.

Accomplishments Since We Acquired Oritavancin

We believe that we have greatly improved the commercial and economic prospects for oritavancin since we acquired worldwide rights to it in December 2005 from InterMune because of actions we have taken that include:

 

   

Regulatory . We have resolved certain outstanding regulatory issues for oritavancin. We submitted data to the FDA regarding a previous concern that, in two Phase 1 studies conducted by InterMune in 2003, oritavancin had an increased rate of injection-site phlebitis (or vascular inflammation). In January 2007, the FDA accepted our assessment of the data we had submitted and agreed to lift the voluntary clinical hold originally requested by InterMune in 2004. Further, the FDA did not object to our plan to file our NDA.

 

   

Potency . We have performed in-vitro potency tests on more than 8,000 recent bacterial isolates, employing an assay that has been accepted recently by the FDA and the national standards-developing organization CLSI. These tests show that oritavancin is as much as 32 times more potent than previously shown by Lilly and InterMune and has superior potency against a broad spectrum of gram-positive bacteria compared with tests conducted by us or published data on the potency of other antibiotics.

 

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Economic . We were able to negotiate a substantially lower royalty obligation to Lilly than would have been payable to Lilly by InterMune, oritavancin’s previous licensee.

Background on the Antibiotic Market

Infectious diseases are caused by pathogens present in the environment, such as bacteria, fungi and viruses that enter the body through the skin or mucous membranes of the lungs, nasal passages or gastrointestinal tract, and overwhelm the body’s immune system. These pathogens establish themselves in various tissues and organs throughout the body and cause a number of serious and, in some cases, lethal infections, including infections of the bloodstream, skin, heart, lungs and urinary tract.

The market for anti-infective agents consists of three main categories: antibacterials (often referred to as antibiotics), antifungals and antivirals. Antibiotics work by inhibiting a function essential to the pathogen’s survival, usually by binding to and thereby inhibiting one or occasionally more than one specific “target” in a bacterial pathogen. Antibiotics are classified by both the type of bacteria for which they are effective, such as gram-positive or gram-negative pathogens, as well as their basic molecular structure, which is known as their antibiotic “class.”

Gram-positive bacteria are differentiated from gram-negative bacteria by the structure of the bacterial envelope. Gram-positive bacteria possess a single membrane and a thick cell wall, whereas gram-negative bacteria possess a double membrane with a thin cell wall. We believe that the most clinically important gram-positive pathogens include Staphylococcus aureus , streptococci and enterococci, and frequently observed infections caused by gram-positive pathogens include cSSSI, hospital-acquired and community-acquired pneumonia, bacteremia and osteomyelitis.

There is a growing need for novel antibiotics because bacteria mutate quickly and often develop resistance to existing antibiotics. Hospital-acquired infections are particularly likely to be resistant to existing antibiotics, but resistance is also growing rapidly in community-acquired infections. As bacteria become more resistant to the current generation of marketed antibiotics, an increasing prevalence of drug-resistant bacterial pathogens can lead to increased mortality rates, prolonged hospitalizations, and increased healthcare costs.

According to IMS Health, antibiotics designed to treat serious infections caused by resistant gram-positive bacteria accounted for approximately $945 million in United States sales in 2006 and this market is rapidly growing. Uses of antibiotics to treat serious gram-positive infections have increased at a compounded annual growth rate of 12% since 2002, while revenues have increased more rapidly due to the introduction of premium- priced antibiotics into the market. Vancomycin, the first clinically useful glycopeptide, was introduced in 1958 and, according to IMS Health, still accounts for 85% of courses of therapy in the United States for resistant gram-positive pathogens. Since the 1960s, we only know of two antibiotics from new chemical classes effective against gram-positive pathogens that have been approved by the FDA—Cubicin, a lipodepsipeptide, which is known generically as daptomycin, is marketed by Cubist; and Zyvox, an oxazolidinone, which is known generically as linezolid, is marketed by Pfizer.

Limitations of Antibiotics Currently Marketed for Gram-Positive Infections

The Emergence of Drug Resistance

We believe that for the past twenty years, vancomycin has been the treatment of choice for patients who have serious gram-positive infections that have failed to respond to most other antibiotics. However, several strains of enterococci, staphylococci and other pathogens have developed resistance to vancomycin. In addition, resistance to linezolid and daptomycin has emerged in both staphylococci and enterococci in recent years. Some pathogens have become resistant to almost all antibiotics. Examples of antibiotic-resistant gram-positive pathogens include:

 

   

MRSA (methicillin-resistant Staphylococcus aureus ): Staphylococcus aureus (or S. aureus ) is a bacterium that can be virulent or deadly, but can often be treated effectively with methicillin-based

 

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antibiotics. Methicillin-resistant S. aureus , or MRSA, is an increasingly common bacterial pathogen that causes serious and life-threatening infections. According to the Centers for Disease Control and Prevention, 63% of total S. aureus infections were methicillin-resistant in 2004, as compared with 22% in 1995.

 

   

CA-MRSA (community-acquired methicillin-resistant S. aureus) : While MRSA has historically been found primarily in hospitals and long-term care settings, the incidence of CA-MRSA infections continues to rise rapidly. According to an August 2006 article in the New England Journal of Medicine, when looking at data in 2004 from eleven university-affiliated emergency departments, the prevalence of CA-MRSA ranged from 15% to 74%, with 59% of overall patients enrolled in the study presenting with CA-MRSA. The prevalence of CA-MRSA has substantially changed the prescribing behavior of infectious disease physicians, from penicillin and celphalosporin-class drugs, among others, which are now ineffective against these pathogens, to antibiotics such as daptomycin and linezolid.

 

   

GISA or VISA (glycopeptide- or vancomycin-intermediately susceptible S. aureus ): The first reports of S. aureus infections with decreased susceptibility to vancomycin occurred in Japan in 1996. These bacterial strains have been found in wide geographic areas throughout Japan, North America and Europe. In an April 2004 article published on the website of the Centers for Disease Control and Prevention, Robin A. Howe, et al. estimated that the incidence of VISA around the world was between 0.5% and 20%.

 

   

VRE (vancomycin-resistant enterococci): Enterococci are bacteria that are commonly found in the intestinal tract. Pathogenic enterococci commonly cause bloodstream infections in immunocompromised patients. Many antibiotics are ineffective in treating these infections. The emergence of VRE strains in the 1990s has led to infections for which only limited commercially available therapy exists. VRE is commonly treated today with daptomycin and linezolid, but bacteria resistant to each of these drugs have recently begun to emerge.

 

   

VRSA (vancomycin-resistant S. aureus ): During 2002, the first isolates of S. aureus fully resistant to vancomycin were discovered in the United States. While VRSA is growing slowly in incidence, any acceleration of its incidence would lead to an immediate change in the antibiotics used for first-line therapy of gram-positive infections in hospital settings.

There are a limited number of antibiotics currently available to treat these and other resistant gram-positive pathogens, and therefore a growing need exists for new therapies with novel mechanisms of action. A significant trend in the antibiotic marketplace is that most large pharmaceutical companies discontinued or sharply reduced their research into antibiotics beginning in the 1980s and 1990s. As a result, there have been fewer new antibiotics entering the market in the past few years, and the threat of pathogens resistant to the existing antibiotics has continued to increase.

Shortcomings of Currently Marketed Antibiotics for Gram-Positive Infections

In addition to the increasing resistance of bacteria to existing antibiotics, currently available antibiotics do not provide adequate or ideal treatment for some serious and life-threatening infections. Shortcomings of current antibiotics for the treatment of gram-positive infections include:

 

   

Bacteriostatic Activity. Bacteriostatic antibiotics merely inhibit the growth of pathogens and rely on the immune system to actually kill the bacteria. Bacteriostatic drugs are less effective in treating diseases such as endocarditis (an infection of the heart valves) than are bactericidal antibiotics, which can kill bacteria directly. Bacteriostatic drugs are also less effective in treating patients with compromised immune systems that cannot rid their bodies of the pathogens. Based on our market research, we believe that infectious disease physicians prefer bactericidal antibiotics for serious gram-positive infections.

 

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Narrow Spectrum of Coverage. The range of bacteria treated by a drug is called its “spectrum.” Many antibiotics are effective against some serious pathogens but not others. Hospital-acquired infections can be complicated and may be caused by more than one kind of pathogen. Since these infections can be life threatening, physicians often cannot wait for the test results necessary to identify the exact nature of the pathogen or pathogens causing the infection, and must treat immediately with an antibiotic or combination of antibiotics with a broad spectrum against many of the most likely types of bacteria.

 

   

Inconvenient Administration. Many of the existing antibiotics used to treat serious infections are difficult or inconvenient to administer. Many drugs are given twice daily for seven to fourteen days, or more, and patients can be hospitalized for much or all of this period.

 

   

Serious Side Effects Requiring Careful Patient Monitoring. Existing antibiotics may cause serious side effects in some patients, such as severe allergic reaction, decreased blood pressure, suppression of the bone marrow, inflammation, swelling at the site of injection, muscle toxicity, optic and peripheral neuropathies and headaches. Some of these side effects may be significant enough to require that therapy be discontinued in some patients. Due to these side effects, costly and time-consuming monitoring of blood levels and other parameters is required with the use of a number of currently available therapies.

Preferred Attributes of New Antibiotics

As a result, there is a significant need for new antibiotics that address the limitations of currently available products. Based on our market research, we believe that infectious disease physicians most desire the following attributes in new antibiotics:

 

   

Greater efficacy: Physicians see the greatest need for antibiotics that improve cure rates and clinical outcomes for patients as compared to currently available treatment options.

 

   

Fewer side effects: Physicians desire antibiotics that have reduced side effect profiles compared to currently available antibiotics, many of which have side effect profiles that limit the duration of therapy.

 

   

Fewer treatment issues: Physicians express a preference for treatments that require a minimum of expensive and time-consuming monitoring, such as for peak/trough levels or for platelets and white blood cells. Physicians also prefer treatments that require fewer dosing adjustments, such as for renally or hepatically impaired patients.

 

   

Better hospital economics: Physicians express a preference for efficacious treatments that require less treatment intensity and shorter duration of therapy, resulting in shorter hospital stays.

We believe that oritavancin has most of the attributes that infectious disease physicians prefer and could provide an efficacious, safe and novel antibiotic for the treatment of serious gram-positive infections. In addition, we believe that oritavancin could provide significant pharmoeconomic benefits by reducing the need for patient monitoring and shortening hospital stays.

Our Clinical Development Candidate—Oritavancin

Oritavancin is a novel, semi-synthetic glycopeptide that we are developing for serious gram-positive infections in the hospital. As a glycopeptide, oritavancin shares some properties of other members of the glycopeptide class of antibiotics, which includes vancomycin, the current standard of care for serious gram-positive infections in the United States and Europe, as well as telavancin, for which an NDA was filed in 2006. However, we believe that oritavancin differs from other glycopeptides, as well as other classes of gram-positive antibiotics, in several important ways, including the following:

 

   

Rapidly Bactericidal and Potentially Less Likely to Engender Resistance. Similar to other glycopeptides, oritavancin disrupts cell wall synthesis by bacteria. However, oritavancin inhibits two

 

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separate enzymes involved in cell wall synthesis while most other glycopeptides, including vancomycin, inhibit a single enzyme. Further, oritavancin also causes the rapid rupture of bacterial membranes, leading to significantly more rapid killing of the bacteria (known as bactericidal activity) as compared to vancomycin and other antibiotics. Taken together, these multiple mechanisms of action may reduce the potential for the emergence of strains of bacteria that are resistant to oritavancin as compared with other antibiotics. To date, no resistant strains have been observed in any clinical trials, and laboratory efforts to cultivate oritavancin-resistant bacteria have proved less successful than is historically the case with most non-glycopeptide antibiotics.

 

   

Broad Spectrum Against Gram-Positive Bacteria . In-vitro testing indicates that, compared to other antibiotics, oritavancin treats the broadest spectrum of gram-positive pathogens, including organisms resistant to vancomycin and other antibiotics such as linezolid and daptomycin. Unlike vancomycin, oritavancin has been shown to kill quiescent or non-dividing bacteria, such as those found in biofilm, as well as actively dividing bacteria, suggesting potential utility in treating endocarditis, as well as device and catheter related infections.

 

   

Superior In-Vitro Potency. We have performed in-vitro tests on over 8,000 recent bacterial clinical isolates, employing an assay accepted by both the FDA and the Clinical Laboratory Standards Institute (or CLSI). These tests show that the potency of oritavancin is up to 32 times greater than demonstrated in earlier testing done by Lilly and InterMune and that oritavancin has superior potency against a broad spectrum of gram-positive pathogens compared with tests conducted by us or published data on the potency of other antibiotics.

 

   

Lower Incidence of Adverse Events . Oritavancin has been shown in clinical trials to have a lower rate of adverse events than vancomycin, and its published adverse events rates compare favorably against those published for other antibiotics against resistant gram-positive infections. Unlike other glycopeptides, including vancomycin, telavancin and dalbavancin, oritavancin has not required, in clinical trials to date, monitoring of blood levels for the purpose of adjusting the blood level of the glycopeptide due to hepatic or renal insufficiency. Further, unlike certain other antibiotics for gram-positive infections, oritavancin did not elevate muscle enzymes, and did not significantly prolong QT interval or cause other electrophysiological changes.

 

   

Favorable Elimination Profile. Unlike many other antibiotics, oritavancin is not metabolized and is slowly eliminated from the body as unchanged drug, substantially reducing the potential for adverse events such as renal toxicity or delayed hypersensitivity that might be due to reactive metabolites.

 

   

Long Half-Life. The in-vivo half-life of oritavancin is significantly longer than the half-lives of most potential competitors. This enables oritavancin to be administered daily, or potentially less frequently. Oritavancin’s Phase 3 trials in cSSSI, for example, tested the compound in a regimen of one dose per day for only three to seven days, substantially less than the labeled or tested regimens of other antibiotics against gram-positive infections. We also believe that a higher dose of the drug may prove effective in treating cSSSI using a single administration, which may be useful in non-hospital institutional settings such as nursing homes, or for patients being discharged from hospitals. We believe that azithromycin, a long-acting antibiotic, has demonstrated that a long-acting antibiotic can be commercially successful once clinicians are convinced it has a benign adverse event profile. We plan to begin a Phase 2 study in 2007 and a Phase 3 study in 2008 to evaluate a single or infrequent dose regimen of oritavancin for cSSSI.

 

   

Potential Efficacy in Bacteremia. Oritavancin has completed two Phase 2 studies in bacteremia with successful outcomes, including a Phase 2 study where vancomycin was used as the comparator and, based on these results, we plan to begin a Phase 3 bacteremia study in 2008. Many other antibiotics used against gram-positive pathogens are ineffective against bacteremia or have toxicities that may limit their use for longer durations.

Based on these advantages, we believe that oritavancin has the potential to become a leading antibiotic used to treat serious gram-positive infections.

 

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Our Strategy

We hold the worldwide rights to oritavancin and our strategy is to develop oritavancin into a leading therapy worldwide for the treatment of serious gram-positive infections, initially for the treatment of cSSSI and subsequently for other indications. Specifically, we plan to:

 

   

Obtain regulatory approval for oritavancin for the treatment of cSSSI in the United States;

 

   

Build a hospital-directed sales force to commercialize oritavancin in the United States;

 

   

Pursue clinical development of oritavancin in other dosing regimens and for additional indications;

 

   

Submit a marketing authorization application for oritavancin in the EU and evaluate the potential for a blended commercialization strategy composed of proprietary sales and partnerships with third parties;

 

   

Out-license oritavancin to third parties for commercialization in key Asian countries; and

 

   

Pursue the development of other innovative antibiotics for the hospital market, either through in-licensing or internal development.

Clinical Development Status—Oritavancin

Oritavancin has been tested in over 1,500 patients. Oritavancin has completed two Phase 3 trials for cSSSI in which the primary endpoints were successfully met, as well as two Phase 2 bacteremia trials conducted by Lilly and InterMune.

We are currently in the process of preparing our NDA submission to the FDA for oritavancin for the treatment of cSSSI caused by or associated with susceptible strains of the following designated microorganisms: Enterococcus faecalis (including vancomycin-resistant strains), Enterococcus faecium (including vancomycin-resistant strains), S. aureus (including methicillin-resistant strains), Streptococcus agalactiae , Streptococcus pneumoniae , Streptococcus pyogenes , S. epidermidis , Streptococcus Group C and G, and Viridans Group streptococcus. Based on clinical results and our pre-NDA meeting with the FDA on January 31, 2007, we believe that the two Phase 3 clinical studies that have been completed with oritavancin will support regulatory approval for this indication.

Assuming we obtain FDA approval, we plan to launch oritavancin with an indication for cSSSI and then seek to broaden the label for other indications. The following chart summarizes our clinical development and regulatory plan for oritavancin:

 

Gram-Positive Indication

  

Oritavancin Dosing Regimen

   Development Status

cSSSI

   3 to 7 days of once-daily therapy    NDA expected to be submitted
in the first quarter of 2008
cSSSI for hospital discharge, nursing home or outpatient use    Single or infrequent administration of higher-dose therapy    Phase 2 clinical study expected
to begin later in 2007

Bacteremia

   Approximately 7 to 14 days of higher-dose, once-daily therapy    Two Phase 2 clinical studies
completed

 

Phase 3 clinical study expected
to begin in 2008

Osteomyelitis

   To be determined    Phase 2 clinical study expected
to begin in 2008 depending on
the results of confirmatory pre-
clinical studies

 

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The following are highlights of the attributes of oritavancin observed in pre-clinical and clinical studies completed to date:

 

   

Activity Against MRSA and VRE. Oritavancin has demonstrated efficacy against MRSA in Phase 2 and Phase 3 clinical trials and against VRE in Phase 2 clinical trials. Oritavancin has also demonstrated efficacy against MRSA and VRE in extensive in-vitro studies. This is important given the increased incidence of resistant gram-positive pathogens found in hospitals and in the community, which threatens to limit the usefulness of existing antibiotic treatment options.

 

   

Less Likelihood of Drug Resistance. No resistance to oritavancin has been observed in clinical trials to date, while resistance has often emerged to other antibiotics in their clinical trials. Recently published reports indicate instances of resistance to daptomycin and linezolid. To date, our laboratory efforts to cultivate oritavancin-resistant bacteria have proved less successful than is historically the case with most non-glycopeptide antibiotics.

 

   

Clinical Efficacy. In two Phase 3 clinical trials in cSSSI, oritavancin was shown to be non-inferior to a combination of vancomycin followed by cephalexin. Oritavancin was effective with only three to seven days of daily intravenous therapy in patients with cSSSI, with an average duration of treatment of 5.3 days, compared with the vancomycin / cephalexin combination, which required use for up to fourteen days and had an average duration of treatment of 10.9 days.

 

   

Broadest Spectrum. In bacteriology tests that we performed against more than 8,000 recent clinical isolates, oritavancin appears to have the broadest spectrum in its class against susceptible gram-positive and resistant gram-positive pathogens. These in-vitro studies indicate that oritavancin has retained its efficacy against certain pathogen strains that are already resistant to daptomycin, linezolid or vancomycin.

 

   

Rapid Bactericidal Activity. Oritavancin causes the rapid rupture of bacterial membranes, leading to significantly faster killing of the bacteria as compared to many other antibiotics.

 

   

Favorable Safety Profile. Oritavancin was well tolerated in Phase 3 clinical trials and, compared to control arms, exhibited a favorable safety profile and a lower discontinuation rate due to adverse events.

Summary of Pre-clinical Data

In pre-clinical studies, oritavancin exhibited a broad spectrum of activity against gram-positive pathogens that included bacteria associated with cSSSI, pneumonia and bacteremia, and bacteria that are resistant to other drugs.

Recently improved methodology has been established that allows the true potency of oritavancin to be observed in in-vitro microbiological tests. These methods, concordant with FDA and CLSI methods established for other lipoglycopeptides, include a wetting agent that prevents oritavancin from unintentionally binding to the surfaces of the testing vessels. This allows the potency of oritavancin observed to reflect the activity of the concentration of antibiotic that was added into the test, rather than a small fraction of that concentration that remains following the binding to the surfaces in the absence of the innocuous concentration of the additional ingredient.

In recent studies performed by and for us, the in-vitro antibacterial activity of oritavancin against certain pathogens has been shown to be superior to other glycopeptides and to other antibiotics, both marketed and currently in development. In addition, based on in-vitro studies, we believe oritavancin will be effective against VRSA and VISA. No approved antibiotics are labeled to treat infections caused by these pathogens.

In a large study we recently conducted with more than 8,000 contemporary bacterial clinical gram-positive isolates collected from the United States, Europe and Israel, oritavancin demonstrated potent activity against

 

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staphylococci, enterococci and streptococci, regardless of resistance to other antimicrobial classes. The following table shows the antibacterial activities of oritavancin in this study, compared with studies we performed on vancomycin, linezolid and daptomycin, as well as published studies on linezolid, daptomycin, dalbavancin and telavancin. The MIC 90 value shown in the table is the minimum concentration of drug required to inhibit growth of 90% of the bacterial isolates within a given population. The lower the MIC 90 value for a given drug, the more potent the drug is against that specific type of bacteria. In these studies, oritavancin was shown to be the most potent antibiotic against virtually every gram-positive organism evaluated. Collectively, we believe these data indicate the potent activity of oritavancin against important and serious pathogens.

Activity of oritavancin by broth microdilution

 

    

Phenotype*

   MIC 90 or MIC range (µg/mL)

Organism

      Oritavancin    Vancomycin    Linezolid    Daptomycin    Dalbavancin    Telavancin

S. aureus

   MSSA    0.12    1    2    0.5    0.06-0.5    0.5
   MRSA    0.25    1    2    0.5    0.06-1    0.5
   CA-MRSA    0.06-0.12    0.5    2    0.25    Unknown    0.5
   VISA    1    8    2    4    1-2    2
   VRSA    0.12-0.5    ³ 64    1-2    0.25-0.5    2    2-4

E. faecalis

   VAN S    0.06    2    2    2    0.06    1
   VAN R    1    >256    2    2    32    16

E. faecium

   VAN S    0.015    1    2    4    0.12    0.25
   VAN R    0.25    >256    2    4    32    8

S. pneumoniae

   PEN S    0.004    0.25    2    0.5    0.016-0.06    0.03
   PEN R    0.008    0.5    2    0.25    0.016-0.03    0.015

*   MSSA, methicillin-sensitive S. aureus (which is S. aureus that responds well to methicillin); MRSA, methicillin-resistant S. aureus ; CA-MRSA, community-acquired MRSA; VISA, vancomycin-intermediate S. aureus ; VRSA, vancomycin-resistant S. aureus ; VAN S, vancomycin-sensitive; VAN R, vancomycin-resistant; PEN S, penicillin-sensitive; PEN R, penicillin-resistant.

Activity of oritavancin against important resistance phenotypes

Oritavancin maintains strong activity against organisms that have acquired resistance to other antibiotics. Taken together, the potency of oritavancin is, as demonstrated in the following table, as good as or better than all competitors against bacteria with acquired resistance phenotypes.

 

         

MIC 90 (ug/ml)

(or range*)

Type of Resistance

   Number of
Strains Tested
   Oritavancin   Vancomycin   Daptomycin   Linezolid

Daptomycin resistant S. aureus

   16    1   8   4     2

Linezolid resistant S. aureus

   13    0.25   2   1   >8

VISA

   13    1   8   4     2

VRSA

   5    0.12-0.5*   64->64*   0.25-0.5*   1-2*

*   Ranges are used where the number of strains available for testing is less than 10.

 

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The rapid bactericidal activity of oritavancin is helpful in killing bacteria arranged in biofilms. In a biofilm, bacteria are arranged in a relatively impermeable matrix, in which their metabolic state is impaired and their susceptibility to antibiotics is substantially reduced. Biofilm studies are aimed in part to address the clinical challenge posed by the recognition that 50% to 80% of all hospital-acquired infections, including endocarditis, device- and catheter-related infections, and bacteremia, may be derived from biofilm-related bacteria. Our recent in-vitro studies demonstrate that relative to vancomycin, oritavancin antibacterial activity is the least impacted by slow-growing and biofilm bacteria. Of these antibiotics, oritavancin was the only antibiotic capable of sterilizing biofilms that were previously established with a clinical isolate of MSSA. Furthermore, oritavancin was the only glycopeptide of those tested that retained bactericidal activity, defined as killing 99.9% of input bacteria, against slow-growing MSSA in broth medium. Our further evaluation of oritavancin activity in-vitro and in-vivo against slow-growing and biofilm bacteria is underway.

Oritavancin has been found to be efficacious in many animal models. Its efficacy was demonstrated in a mouse model of acute pneumonia infection caused by Streptococcus pneumoniae (or S. pneumoniae ) susceptible or resistant to penicillin; in rat models of central venous catheter-associated infection caused by S. aureus and VRE; in rabbit models of endocarditis caused by MRSA and vancomycin-susceptible or -resistant Enterococcus faecalis ; in rabbit models of meningitis caused by S. pneumoniae susceptible or resistant to penicillin and cephalosporin-class antibiotics. In a rat granuloma pouch model of S. aureus infection, the in-vivo bactericidal activity of oritavancin was more rapid and was sustained longer than that of vancomycin. The efficacy demonstrated in that model supports our hypothesis that infrequent dosing of oritavancin may be applicable in treating infections caused by gram-positive bacteria. We continue to evaluate our pre-clinical data to determine which indications to move into clinical trials. If we commence clinical trials in any of these indications, there can be no assurance that these trials will be successful.

Summary of Clinical Data

Phase 3 Trials

The efficacy of oritavancin in subjects with cSSSI was evaluated in two separate randomized, double-blind, controlled Phase 3 studies, called ARRD (completed in 2001) and ARRI (completed in 2003). These studies were designed to determine whether oritavancin was non-inferior based on its clinical cure rate to a combination of vancomycin and cephalexin. The ARRD study evaluated two different weight-based doses of oritavancin, 1.5 mg/kg/day and 3.0 mg/kg/day, compared to 15 mg/kg of vancomycin administered twice-daily. The ARRI study evaluated a fixed dose of oritavancin of 200 mg/day for patients weighing less than 110 kg, or 300 mg/day for patients weighing more than 110 kg, compared to 15 mg/kg of vancomycin administered twice-daily.

The protocol in these two studies dictated that the duration of therapy would be longer for patients with MRSA compared with patients with other pathogens. The protocol stated that oritavancin treatment would be stopped, or vancomycin treatment would be changed to cephalexin, when the treating physician determined that the patient had met pre-defined criteria for improvement. To be clinically evaluable, patients had to be found or presumed to be infected with a gram-positive pathogen susceptible to vancomycin and had to receive at least three days of drug therapy. The following chart summarizes the dosing regimens of these studies.

 

     Regimen for Patients with
MRSA Pathogens
  Regimen for Patients with
non-MRSA Pathogens

Oritavancin arm

(total of up to 7 days of treatment)

   Oritavancin once-daily for
7 days (followed by oral
placebo twice-daily)
  Oritavancin once-daily for
3 to 7 days (followed by
oral placebo twice-daily)

Vancomycin comparator

(total of up to 14 days of treatment)

   Vancomycin twice-
daily for 10 to 14 days,
followed by oral
cephalexin twice-daily
  Vancomycin
twice-daily for 3 to 7 days
followed by oral
cephalexin twice-daily

 

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Both studies met their primary endpoints of the proportion of clinically evaluable patients cured at the first follow-up visit between 21 and 28 days after the end of treatment, and both demonstrated statistical non-inferiority of oritavancin to the vancomycin / cephalexin control arm using their respective deltas.

The following tables summarize the clinical results for the cSSSI studies:

Results from First Phase 3 Clinical Trial (ARRD):

 

Arm

   Number of
Clinically
Evaluable
Patients
   Percentage
with Positive
Clinical
Response
 

Comparison with Vancomycin

(95% confidence intervals noted in parentheses)

Oritavancin 3.0 mg/kg once-daily

   127    75.6%   -4.6% percentage difference
(-14.8% worst case, +5.7% best case)

Oritavancin 1.5 mg/kg/ once-daily

   131    75.6%   -4.6% percentage difference
(-14.8% worst case, +5.6% best case)

Vancomycin 15 mg/kg twice-daily

   126    80.2%   N/A

Results from Second Phase 3 Clinical Trial (ARRI):

 

Arm

   Number of
Clinically
Evaluable
Patients
   Percentage
with Positive
Clinical
Response
   

Comparison with Vancomycin
(95% confidence intervals noted in parentheses)

Oritavancin 200 mg once-daily (300 mg for patients with body mass greater than
110 kg)

   676    78.6 %   +2.3% percentage difference
(-3.3% worst case, +7.9% best case)

Vancomycin 15 mg/kg twice-daily

   324    76.2 %   N/A

These studies were designed and conducted after conferring with the FDA to meet the applicable clinical trial guidelines that were in place at the time the trials were designed and commenced. After consultation with the FDA, the first Phase 3 study (ARRD) was designed to demonstrate non-inferiority on the primary endpoint, with a delta, or difference, in cure rate of 15% between oritavancin and the vancomycin comparator, which was the appropriate delta for antibiotics at the time that the trial was commenced in 1999. The second Phase 3 study (ARRI) was designed to demonstrate non-inferiority on the same primary endpoint, with a delta in cure rate of 10%.

Based on pre-clinical and clinical studies, we believe that oritavancin has a favorable safety and tolerability profile. The following tables summarize the adverse events for our two Phase 3 clinical trials:

 

ARRD Trial

  

Oritavancin

(N= 342)

  

Vancomycin

(N = 175)

  

Statistical
Significance
(or p-value)

Discontinuations due to adverse event

   19 (5.6)%    13 (7.4)%    —  

Deaths

   7 (2.0)%    5 (2.9)%    >0.10

Patients with > 1 adverse event

   238 (72.5)%    129 (73.7)%    0.19

Patients with > 1 adverse event possibly related to study drug

   77 (22.5)%    51 (29.1)%    0.23

Patients with > 1 serious adverse event

   57 (16.7)%    34 (19.4)%    0.61

Patients with > 1 serious adverse event possibly related to study drug

   13 (3.8)%    7 (4.0)%    —  

ARRI Trial

  

Oritavancin

(N= 831)

  

Vancomycin

(N = 415)

  

Statistical
Significance
(or p-value)

Discontinuations due to adverse event

   15 (1.8)%    20 (4.8)       0.003

Deaths

   13 (1.6)%    7 (1.7)%    1.000

Patients with ³ 1 adverse event

   388 (46.7)%    240 (57.8)%    <0.001

Patients with ³ 1 adverse event possibly related to study drug

   134 (16.1)%    99 (23.9)%    0.001

Patients with ³ 1 serious adverse event

   50 (6.0)%    34 (8.2)%    0.152

Patients with ³ 1 serious adverse event possibly related to study drug

   1 (0.1)%    2 (0.5)%    0.259

 

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Significant observed side effects in each of our Phase 3 clinical trials were as follows:

 

ARRD Trial

   Percentage of Patients
  

Oritavancin
1.5 mg/kg

(N= 173)

   Oritavancin
3.0 mg/kg
(N = 169)
  

Vancomycin

(N = 175)

Event

        

Nausea and vomiting symptoms

   5.8%    4.1%    5.2%

Phlebitis

   2.9%    4.7%    2.9%

Insomnia

   2.9%    1.8%    4.0%

Injection site reactions

   2.9%    0.6%    2.3%

Apocrine and eccrine gland disorders

   2.3%    1.2%    1.1%

Anxiety symptoms

   2.3%    0.6%    0.6%

Febrile (or seizure) disorders

   2.3%    0.6%    0.6%

Headaches

   —      2.4%    1.1%

Asthenic conditions (like fatigue, malaise or weakness)

   2.3%    1.2%    2.7%

Pruritis (or itching)

   1.7%    3.0%    4.6%

 

ARRI Trial

   Percentage of Patients
  

Oritavancin

(N= 831)

   Difference
> 2%
  

Vancomycin

(N = 415)

Event

        

Headache

   4.9%       5.8%

Nausea

   4.2%       4.8%

Vomiting

   3.7%       4.6%

Abscess

   3.6%       5.1%

Constipation

   3.5%       1.9%

Phlebitis

   3.2%       2.7%

Dizziness

   3.2%       1.7%

Insomnia

   2.9%    <    5.1% (p-value = 0.075)

Diarrhea

   2.5%       3.9%

Pruritis (or itching)

   2.0%    <    8.0% (p-value = < 0.001)

As illustrated in the tables above, the results from our second Phase 3 clinical trial demonstrate that oritavancin exhibited activity and safety profiles similar to those of vancomycin, with improved tolerability.

The FDA confirmed in writing in March 2007 that the non-inferiority design using an active control that was employed in both Phase 3 trials for oritavancin was appropriate for cSSSI. In addition, in three separate meetings, including our pre-NDA meeting on January 31, 2007 in which we specifically discussed the Phase 3 trials, the FDA has not requested that we perform additional clinical trials to demonstrate oritavancin’s efficacy in cSSSI. Since the FDA’s accepted delta for non-inferiority trials for antibiotics that treat serious infections like cSSSI (using a comparator like vancomycin) is now 10%, the FDA has requested that we provide justification, as part of our NDA, for the choice of the 15% non-inferiority delta accepted by the FDA for the first of these two Phase 3 trials. As part of this analysis, the FDA has requested that we provide information on the non-inferiority margin in terms of both the benefit of oritavancin as compared to historical vancomycin and placebo cure rates and in terms of acceptable loss of treatment effect relative to historical vancomycin and placebo cure rates (in a population as similar as possible to the population enrolled in these phase 3 clinical trials). The FDA has indicated that this analysis will be critical to approval of our NDA.

Based on our meetings with the FDA, we believe our two Phase 3 trials demonstrate safety and efficacy sufficient for FDA approval for 200 mg or 300 mg of oritavancin infused once per day for three to seven days for cSSSI. There can be no assurance that our Phase 3 trials included a sufficiently large population of patients to

 

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demonstrate safety and efficacy at these dosage levels or that we will receive FDA approval for the NDA we plan to submit for cSSSI in the first quarter of 2008. In connection with a request from the FDA, we intend to complete a QTc study against a postive control prior to submitting our NDA in the first quarter of 2008.

Other Clinical Studies

Phase 2 Bacteremia Studies

The efficacy of oritavancin in subjects with gram-positive bacteremia was evaluated in two Phase 2 studies conducted by Lilly prior to 2001.

In the first study (ARRC), an open-label non-controlled study, seventeen patients were assigned to a regimen of 5 mg/kg/day of oritavancin for the first day followed by 4 mg/kg/day of oritavancin for seven to ten days as determined by the physician. Ten of the fifteen patients were shown to have gram-positive bacteremia and completed therapy. Nine of those ten patients were successfully treated. The pathogens that oritavancin effectively eradicated from blood culture at first follow-up visit (primary efficacy point) included: VRE, four patients; vancomycin-susceptible E. faecalis (VSE), three patients; S. pneumoniae, one patient; and Methicillin-resistant S. epidermidis (MRSE), one patient.

The second study (ARRM) was an open-label study for patients with staphylococcal bacteremia. Oritavancin was given in doses ranging from 5 mg/kg/day to 10 mg/kg/day, for ten to fourteen days. The comparator was 15 mg/kg of vancomycin (unless adjusted downward due to poor renal function) administered twice-daily. For patients with demonstrated MSSA based on sensitivity testing, the comparator could be a penicillin or cephalosporin alone. (Only four patients were treated with that regimen.) Oritavancin was shown to be effective based on the sponsor-defined combined outcome (eradication from blood culture and clinical improvement) at first follow-up visit. Evaluable patients were assigned as follows:

 

     Evaluable
patients
   Effective
treatment

Oritavancin Treatment

     

5 mg/kg/day

   6    5 (83.3)%

6.5 mg/kg/day

   7    5 (71.4)%

8 mg/kg/day

   24    16 (66.7)%

10 mg/kg/day

   20    16 (80.0)%

All oritavancin patients

   57    42 (73.7)%

Comparator*

   27    19 (70.4)%

*   Comparator, per the study protocol, was to be vancomycin. In a few instances, treating physicians switched to an alternate antibiotic.

We plan to begin a Phase 3 clinical study designed to treat patients with gram-positive bacteremia in 2008.

Hospital or Serious Community-acquired Pneumonia

In animal studies, oritavancin has been shown to have variable activity in bacterial pneumonia. It is active in a mouse model of penicillin-sensitive and penicillin-resistant S. pneumoniae pneumonia. This was demonstrated by a high level of bacterial clearance when infected mice were treated with single or multiple doses of oritavancin. Single dose dose-response studies yielded an ED 50, or dose resulting in 50% of the maximal killing, of 2.8 ± 0.3 mg/kg. Oritavancin was well distributed in lung and was found in mouse lung epithelial lining fluid, known as ELF. The efficacy of oritavancin in the pneumonia model correlates well with the concentrations of oritavancin in lung and ELF. However, in S. aureus pneumonia the activity of oritavancin is less active than vancomycin. Given these mixed results, and human pharmacology studies showing presumed slow accumulation in human lung ELF, we are reevaluating our plans for the bacterial pneumonia indication.

 

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A Phase 1 clinical study (OPUL-001) was conducted to determine and compare the plasma and intrapulmonary concentrations following intravenous oritavancin or vancomycin at apparent steady-state in normal healthy adults. This study demonstrated significant concentrations and exposures to oritavancin in ELF and high concentrations in alveolar macrophages, known as AM. Together with pre-clinical studies, these lung biodistribution and exposure data suggest that dosage regimens of oritavancin can be constructed to be effective in gram-positive pneumonia, provided that tolerability is not an issue in patients. In recent pre-clinical studies in streptococcal and staphylococcal pneumonia to establish a dosage regime for a Phase 2 clinical study, oritavancin showed good activity against streptococcal and lower than expected activity against staphylococcal strains tested. We expect to decide later in 2007 whether to pursue further pre-clinical and/or clinical testing of the efficacy of oritavancin in treating pneumonia.

Single Dose cSSSI

We believe that because of the long half-life of oritavancin in plasma and tissue, and its high level of potency, it should be possible to treat gram-positive cSSSI with a single administration of higher dose oritavancin. As a result, in 2007, we plan to begin a Phase 2 clinical study evaluating oritavancin using a higher total dose in a single administration of therapy for patients with gram-positive cSSSI. Although a high incidence of systemic adverse events was previously observed in clinical trials with an 800 mg dose of oritavancin given daily for several days, the proposed Phase 2 clinical study will use a single administration of a higher dose oritavancin at a slower rate of infusion. Therefore, we expect that the incidence of systemic adverse events observed in earlier trials will be minimized. We believe a single administration of higher dose oritavancin, if it proves successful in the clinic, would be preferred for many patients upon discharge from the hospital, for use in patients who are not admitted to the hospital, or for non-hospital institutional settings such as nursing homes. We believe that for in-hospital use, physicians may prefer once-daily administration of oritavancin, not a single dose per course of therapy.

Inhalation Anthrax

Bacillus anthracis , the causative agent of anthrax, principally causes disease in certain animals, but can also cause infections in humans. The respiratory form of anthrax is often fatal. Anthrax can be used as an agent of biowarfare and bioterrorism, and engineered resistance to multiple drugs could further complicate treatment. The current standard after exposure to anthrax is ciprofloxacin therapy for 60 days. In a collaboration between Targanta and USARAMID (the United States Army biodefense research laboratory at Fort Detrick, Maryland), the efficacy of oritavancin was compared to ciprofloxacin in a mouse model of prophylaxis after exposure to spores of inhalation anthrax. Oritavancin administered intravenously at either 5 or 50 mg/kg as a single dose was approximately as effective as ciprofloxacin at 30 mg/kg administered twice daily for fourteen days. The oritavancin dosing regimen is significantly more convenient than the ciprofloxacin treatment regimen, and compliance with a regimen of a single dose of oritavancin is likely to be higher than with multiple doses of ciprofloxacin over many days. These in-vivo efficacy data in mice suggest that oritavancin might serve as a preferred therapy for prophylaxis or treatment of anthrax. In addition, oritavancin’s multiple mechanisms of action may allow it to retain activity against drug-resistant Bacillus anthracis (including strains engineered to be resistant to vancomycin and ciprofloxacin). We cannot give any assurance that oritavancin will ultimately receive approval for the treatment of anthrax.

Safety and Tolerability Data

Based on pre-clinical and clinical studies, we believe that oritavancin has a favorable safety and tolerability profile. The pharmacokinetics (the distribution and elimination of the drug in the body) of oritavancin following intravenous infusion were evaluated in ten human oritavancin pharmacokinetic studies, including studies in healthy subjects as well as patients with bacteremia, cSSSI, and hepatic insufficiency. Pharmacokinetic analyses include a pooled population analysis of 3,574 plasma concentration values from 380 subjects or patients. Within the dosing ranges tested (up to 1,220 mg daily), the blood levels of oritavancin increase linearly with dose.

 

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Oritavancin is eliminated slowly in the feces and to a lesser extent in the urine. A clinical study showed that mild to moderate hepatic insufficiency does not alter the pharmacokinetics of oritavancin. In a study using all human data relating to pharmacokinetics, a model was developed that showed no correlation between renal function and blood levels of oritavancin. As in animals, no metabolites of oritavancin have been identified in humans.

A Phase 1 study (OCSI-008) was designed and conducted specifically to determine whether there was any potential for oritavancin to prolong QT interval. QT prolongation due to a drug is believed to be predictive of occasional sudden cardiac death, and QT prolongation has been problematic for the quinolone and macrolide (including telithromycin) classes of antibiotics. In addition, pooled cardiac data from the formal pre-clinical and clinical development program were used to define the risk of QT prolongation at the proposed dose for oritavancin of 200 or 300 mg/day for up to seven days. Thorough analysis of all oritavancin QT data does not suggest any signal for concern regarding cardiac safety, including at the proposed clinical doses for oritavancin of 200-300 mg/day. Further, at all doses tested and in the approximately 79 subjects tested in this trial, including at a single infusion of up to 800 mg, we have observed no correlation between exposure to the drug and QT interval.

Study OCSI-008 and its predecessor, study OCSI-007, were designed to assess the possibility of a drug-drug interaction. The study examined the effect of oritavancin on a liver enzyme called CYP 2D6, a cytochrome p450 enzyme that is inhibited by high concentrations of oritavancin in-vitro . We believe that the results of this study do not suggest or signal concern that oritavancin might inhibit this enzyme when the drug is used, including at doses of 200-300 mg/day or with a single dose of 800 mg.

In Phase 3 clinical testing, oritavancin exhibited activity and safety profiles similar to those of vancomycin, with improved tolerability. The two Phase 3 studies have accrued a safety database comprising 1,173 patients with cSSSI who were exposed to oritavancin. In all, oritavancin has been administered to over 1,566 subjects (1,335 patients and 231 healthy volunteers) across all clinical studies. The most common adverse events involved headache, nausea, vomiting, abscess, constipation, phlebitis, dizziness, insomnia, diarrhea and itching, and these were deemed similar to vancomycin in terms of tolerability. In our second and larger Phase 3 study, a smaller percentage of patients given oritavancin discontinued the drug (1.8%) compared with discontinuations of vancomycin / cephalexin (4.8%), suggesting that oritavancin may be better tolerated than vancomycin because cephalexin is known to be well tolerated. No statistically significant difference was measured in this second Phase 3 trial for inflammation at the infusion site (known as injection-site phlebitis) between oritavancin and vancomycin.

Our Resolution of Certain Regulatory Issues

In 2003, InterMune initiated two Phase 1 studies, OSCI 007 and OSCI 008, to evaluate drug-drug interaction and QT prolongation in healthy subjects. Later in 2004, these studies were discontinued by InterMune prior to completion after the observance of inflammation at the infusion site (known as injection-site phlebitis) judged to be unexpectedly greater in incidence and severity than expected. InterMune proposed a self-imposed clinical hold to the FDA. InterMune then performed reviews and analyses of phlebitis in these and other clinical studies to assess the incidence of phlebitis in these studies. Upon completion of this investigation, InterMune concluded that the possible causes of phlebitis in these two studies were either (a) manufacturing deficiencies, (b) an inherent characteristic of oritavancin at higher doses, (c) a difference in response to oritavancin in healthy subjects as compared with patients, or (d) a combination of these factors.

When we acquired the world-wide rights to oritavancin in 2005, we developed and implemented a comprehensive strategy to gain a better understanding of injection-site phlebitis. We concluded that the risk of phlebitis was no higher with oritavancin than with equally potent doses of vancomycin. We first presented the data from our effort to characterize the risk of phlebitis to the FDA at a meeting on July 20, 2006. At our FDA meeting on January 31, 2007, the FDA agreed to remove the clinical hold on oritavancin.

 

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A summary of our interactions with the FDA relating to these issues follows.

Manufacturing Analysis. In the data we presented to the FDA, we performed an exhaustive physicochemical comparison study of all available drug substance and drug product lots using the original and improved assay methodology, thus generating new data for the older lots that were originally assayed with less efficient methods. As part of our evaluation, we performed a pre-clinical assessment of our proposed commercial drug product, which was prepared from drug substance manufactured by Abbott and drug product manufactured by Catalent. Additionally, a single facility performed all of the assays in an attempt to minimize operator and equipment variability. All of the lots were analyzed using several physiochemical assays in addition to the release testing methods. Review and analysis of all the comparison data indicated that there were no significant differences between lots of drug substance and drug product, regardless of manufacturer or age of the material.

Phlebitis Analysis. Further, we conducted a comprehensive review and analysis of injection site phlebitis in all clinical studies. This review included all 1,962 patients and 243 healthy subjects included in these trials. We screened the adverse event database to identify potential cases of injection site phlebitis and then determined the severity of all identified cases of injection site phlebitis. Specific analyses included all injection site reactions, using a more inclusive and clinically relevant definition of injection site phlebitis than InterMune originally used. Injection site reactions that were considered not related to injection site phlebitis ( e.g. bruising) were excluded. We submitted this comprehensive definition of injection site phlebitis to the FDA prior to our July 20, 2006 meeting.

Key Findings from these Analyses. Review and analyses of injection site phlebitis occurrences against drug manufacturing and clinical variables, including study drug administration parameters, in all oritavancin clinical studies that have been conducted to date, showed:

 

   

There was no association between drug substance lot or drug product lot and the incidence of injection site phlebitis, regardless of the date of manufacture.

 

   

Oritavancin administration in our second Phase 3 trial to patients with cSSSI resulted in an incidence of injection site phlebitis of 3.2% compared to 2.7% for the active comparator, vancomycin, which was statistically insignificant.

 

   

In patients with bacteremia at oritavancin doses up to 10 mg/kg/day for up to twelve days (with a maximum dose administered of 1,220 mg/day), the incidence of injection site phlebitis was comparable with equally potent doses of vancomycin.

 

   

When the drug delivery rate of oritavancin (measured in mg/min) was multiplied by the concentration of administered oritavancin (measured in mg/mL), the result had predictive value regarding the incidence of injection site phlebitis. We will use this algorithm to guide the administration of oritavancin at doses above 200 or 300 mg daily in future clinical trials.

After reviewing these comprehensive re-analyses and final reports, the FDA agreed to lift the clinical hold on oritavancin in a pre-NDA clinical meeting on January 31, 2007. At the July 20, 2006 meeting, the FDA requested that Targanta gain clinical experience in a small number of patients with our proposed commercial drug product from Abbott and Catalent. The FDA agreed that we could submit this data after we submit our NDA, as long as it was available for FDA review before they decided on approval of the drug candidate. To satisfy this request from the FDA, drug product produced by Abbott and Catalent will be used in the upcoming Phase 2 clinical study designed to evaluate the efficacy of a single dose of oritavancin in the treatment cSSSI caused by gram-positive bacteria. We plan to begin this Phase 2 study in 2007, and believe we will have the data required for the FDA to consider the drug product produced by Abbott and Catalent within the date constraints for the FDA’s timely review.

 

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Our Research and Discovery Activities

Pro-drugs to Deliver Antibiotics to Bone

While we are focused on the successful development of oritavancin, we are also working on a pre-clinical antibiotic program using a pro-drug approach for the treatment of bacterial osteomyelitis. Osteomyelitis is an inflammatory process accompanied by bone necrosis that results from an underlying microbial infection, primarily caused by the bacterium S. aureus . In general, bacterial osteomyelitis is established as a result of trauma, bone surgery or joint replacement. Bacterial osteomyelitis also appears in cases of reduced vascularization, such as in diabetic and elderly patients. Osteomyelitis is a challenging illness to treat, with a frequent need for surgical intervention and amputations, and is accompanied by frequent relapses. Existing therapies for osteomyelitis often have a prolonged treatment course of more the six weeks.

The main issues associated with the treatment of osteomyelitis are the sheltered environment provided by bones for bacteria, together with the poor distribution of antibacterial drugs in bone. By coupling proven antibiotics to bisphosphonate chemical moeties with high affinity for bone mineral, we have developed novel antibacterial pro-drugs targeting bone. These pro-drugs deliver the parent antibiotics to the bone in higher concentration than the parent drugs. Using our pro-drugs, the parent drugs are gradually released to exert their therapeutic potential over extended periods of time, in some cases weeks after a single injection.

Pharmacokinetic studies in rats and rabbits showed the rapid clearance of the pro-drugs from circulation and their equally rapid uptake in osseous tissues. The release of the parent drug from bone has been monitored, with half lives as short as two days and as long as fourteen days, during which time the bone is continuously infused with the released parent drug. Our goal is to develop an effective therapy for osteomyelitis that permits infrequent dosing. This program is at least two years from beginning clinical trials and there can be no assurance that we will commence clinical trials or that those clinical trials will be successful.

Commercialization Strategy

Our commercialization strategy is to develop oritavancin into a leading therapy worldwide for the treatment of serious gram-positive infections, initially for the treatment of cSSSI and subsequently for other indications.

We intend to build a commercial organization in the United States focused on promoting oritavancin to physicians, nurses and pharmacy directors principally in hospitals and other institutional settings. We plan to recruit an experienced sales organization supported by an internal marketing organization, and plan to target institutions with the greatest use of intravenous drugs for gram-positive infections. We estimate that a sales force of approximately 75-100 people will reach the 1,300 highest prescribing institutions, which we believe represents the bulk of the initial market opportunity for the product for once-daily administration in cSSSI. We currently have no sales representatives and we intend to recruit sales representatives and regional managers who have extensive hospital-based sales experience and who have previously sold antibiotics to the hospitals in their territories. We expect that oritavancin will initially be used for patients not improving after treatment of vancomycin, for patients with identified vancomycin-resistant pathogens, or in hospitals or regions where the incidence of pathogens resistant to other drugs is high.

We believe the European market for drugs to treat serious gram-positive infections is highly concentrated, and that a launch using a direct sales force may be achievable in major markets. In 2007, we intend to explore the merits of a blended commercialization strategy in Europe through market analysis and discussions with potential partners, and hope to begin implementing a commercialization strategy following confirmation of our expected EU approval timeline in 2008. We also believe that there is a rapidly growing market for antibiotics treating serious gram-positive infections in the major Asian countries, including Japan, Korea, Taiwan, and China. Later in 2007, we plan to begin discussing potential sales and marketing agreements for the major Asian markets, including Japan and Korea.

 

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Third-Party Reimbursement and Pricing

In the United States and elsewhere, sales of pharmaceutical products depend in significant part on the availability of coverage and reimbursement to providers and the consumer from third-party payors, such as government and private insurance plans. These third-party payors are increasingly challenging and negotiating the prices charged for medical products and services based on their degree of value to the patient. We believe that the core clinical attributes of oritavancin, including its superior potency, reduced susceptibility to resistance, activity across the entire gram-positive spectrum, short duration of therapy, and favorable side effect profile, will enable us to differentiate the product from other competitive therapies and ultimately will lead to its widespread adoption by hospital formularies and also to reimbursement by third-party payors. We intend to price oritavancin in the United States on a course of therapy basis consistent with other novel gram-positive antibiotics.

In many foreign markets, including the countries in the EU, pricing of pharmaceutical products is subject to governmental control. Evaluation criteria used by many European government agencies for the purposes of pricing and reimbursement typically focus on the product’s degree of innovation and its ability to meet a clinical need unfulfilled by currently available therapies. We believe that oritavancin’s core attributes will enable us to negotiate a competitive or premium price for the product in countries where pricing is set by a government agency, and to obtain reimbursement for the product from the responsible agencies in each market. As in the United States, we intend to price the product competitive with other novel gram-positive antibiotics on a course of therapy basis.

Competition

Oritavancin is expected to compete with a number of drugs that target serious gram-positive infections acquired or treated in hospitals. Most of our existing and potential competitors have substantially greater financial, technical and personnel resources than we have. In addition, most of these competitors have significantly greater commercial infrastructures than we have.

We anticipate that, if approved, oritavancin will compete with vancomycin, a generic drug that is manufactured by a variety of companies, as well as other drugs targeted at gram-positive bacterial infections. These include daptomycin (marketed by Cubist as Cubicin), linezolid (marketed by Pfizer as Zyvox), quinupristin / dalfopristin (marketed by Sanofi-Aventis and Monarch Pharmaceuticals as Synercid), and teicoplanin (marketed outside the US by Sanofi-Aventis as Targocid). In addition, NDAs have been filed for dalbavancin (being developed by Pfizer as Zeven) and telavancin (being developed by Theravance and Astellas). Further, NDAs are expected to be filed in the next year for ceftobiprole (being developed by Johnson & Johnson and Basilea) and iclaprim (being developed by Arpida). These drug candidates represent potential competition for oritavancin. All of these companies are larger than we are and have significantly greater resources. Further, most of the drugs discussed above are either already established in the market or are expected to be commercialized before we launch oritavancin.

Manufacturing and Supply Chain Management

We obtain oritavancin drug substance from our contract manufacturer, Abbott, and obtain final drug product from our contract fill/finish provider, Catalent. We also plan to add a second fill/finish provider prior to commercial launch of oritavancin. Our final drug product is currently packaged as a lyophilized presentation of 100 milligrams in a 20 cc single-use vial and we expect this to be our packaging size and presentation when we launch the product. These contract manufacturers are the sole manufacturing sources of oritavancin at this time, but we believe that we could locate alternative suppliers if necessary. We believe our employees have the necessary expertise to manage the supply chain for oritavancin for the United States market and the European market, should we receive regulatory approval to commercialize oritavancin.

 

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Lilly developed the original oritavancin diphosphate drug substance manufacturing process and it was the process used to manufacture the drug product used to conduct the initial toxicology and non-clinical studies, as well as to prepare drug product for all clinical trials performed to date.

The Lilly drug substance manufacturing process was transferred to Abbott in 2002 by InterMune. After the process was transferred to Abbott, the new drug substance process was validated in three consecutive runs following completion of two successful engineering runs and three registration stability batches. This campaign has provided sufficient inventory to support the launch of oritavancin, as we currently have approximately 100 kilograms of drug substance material in cGMP storage, which upon completion of the fill/finish process translates into approximately 100,000 courses of therapy. We plan to use this new drug substance material in clinical trials later this year, and it will be this material that we will use to provide data on the twenty to sixty clinical patients we plan to submit to the FDA prior to their evaluation of our NDA.

In November 2006 and again in January 2007, we met with the FDA to discuss the chemistry, manufacturing and control (or CMC) portions of the NDA submission requirements. Although the FDA cannot finalize decisions until the agency has reviewed all the data included in the submission, we believe they have provided sufficient guidance to enable us to prepare a successful submission package in the first quarter of 2008.

In December 2006, we amended our development and supply agreement with Abbott to provide that Abbott would seek to develop and validate a drug substance process in which all animal sourced materials (or ASMs) would be eliminated. This work is targeted to be completed in 2008 or later. We hope to deliver sufficient quantities of validated drug substance to serve as an alternate supply of drug substance, but this work is not required for our expected launch of oritavancin in the United States.

Prior to submitting our NDA for oritavancin, we will conduct a two-week bridging study of oritavancin in rats, using drug substance produced by Abbott and further processed by a contract research laboratory to increase the level of total impurities, to demonstrate that exposure to impurities found in oritavancin (even at the artificially increased levels found in the enhanced samples used for these tests) is safe in accordance with acceptable toxicity requirements. We expect to finalize the results of this additional toxicology testing in advance of and in time for inclusion in our NDA submission for oritavancin for cSSSI.

Government Regulation

The development and commercialization of our product candidates and our ongoing research will be subject to extensive regulation by governmental authorities in the United States and other countries. Before marketing in the United States, any medicine we develop must undergo rigorous pre-clinical studies and clinical trials and an extensive regulatory approval process implemented by the FDA under the Federal Food, Drug and Cosmetic Act. Outside the United States, our ability to market a product depends upon receiving a marketing authorization from the appropriate regulatory authorities. The requirements governing the conduct of clinical trials, marketing authorization, pricing and reimbursement vary widely from country to country. In any country, however, we will only be permitted to commercialize our medicines if the appropriate regulatory authority is satisfied that we have presented adequate evidence of the safety, quality and efficacy of our medicines.

 

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Before commencing clinical trials in humans in the United States, we must submit to the FDA an Investigational New Drug application, or an IND, that includes, among other things, the results of pre-clinical studies. If the FDA does not reject or place on hold the submitted IND application for safety reasons, clinical trials are usually carried out in three (and occasionally four) phases and must be conducted under FDA oversight. These phases generally include the following:

 

Phase 1.    The product candidate is introduced into humans and is tested for safety, dose tolerance and pharmacokinetics.
Phase 2.    The product candidate is introduced into a limited patient population to assess the efficacy of the drug in specific, targeted indications, assess dosage tolerance and optimal dosage, and identify possible adverse effects and safety risks.
Phase 3.    If a compound is found to be potentially effective and to have an acceptable safety profile in Phase 2 evaluations, the clinical trial will be expanded to further demonstrate clinical efficacy, optimal dosage and safety within an expanded patient population at geographically dispersed clinical study sites.
Phase 4.    Clinical trials are studies required of or agreed to by a sponsor that are conducted after the FDA has approved a product for marketing.

The FDA’s role is to review and provide guidance on clinical trial designs, evaluating specifically the safety and efficacy of the trial design, prior to drug developers undertaking these clinical trials of drug product candidates. In the case of antibiotics for serious, gram-positive infections, drug developers typically rely on non-inferiority studies, the goal of which is to show that a product candidate is not less effective than the approved standard of care. Though historically the FDA had considered a non-inferiority clinical trial for antibiotics that treat serious infections like cSSSI (using a comparator like vancomycin) successful if the delta, or difference, between the tested drug product candidate and the approved standard of care was not more than 15%, the current FDA accepted delta for non-inferiority for this type of clinical trial is 10%.

The applicant must submit to the FDA the results of its pre-clinical and clinical trials, together with, among other things, detailed information on the manufacture and composition of the product and proposed labeling, in the form of an NDA, including payment of a user fee. The FDA reviews all submitted NDAs before it accepts them and if the FDA does not believe that an NDA has sufficient information to allow a thorough review, the agency will refuse to file the NDA. However, most NDA submissions are accepted and filed 60 days after they are submitted. Once the submission is accepted for filing, the FDA begins an in-depth review of the NDA. Under the policies agreed to by the FDA under the Prescription Drug User Fee Act (or PDUFA), the FDA has ten months from the date of NDA submission in which to complete its initial review of a standard NDA and respond to the applicant. The review process and the PDUFA goal date may be extended by three months if the FDA requests or the NDA sponsor otherwise provides substantial additional information or clarification regarding information already provided in the submission within the last three months of the PDUFA goal date. The review process and the PDUFA goal date may be as short as six months if the FDA grants priority review of a submission.

If the FDA’s evaluations of an NDA and the clinical and manufacturing procedures and facilities are favorable, the FDA may issue either an Approval letter or an Approvable letter, the latter of which contains the conditions that must be met in order to secure final approval of the NDA. If we were to receive an Approvable Letter, we may need to expend considerable time and expense in order to receive FDA approval. If and when those conditions have been met to the FDA’s satisfaction, the FDA will issue an Approval letter, authorizing commercial marketing of the drug for certain indications. According to the FDA, the median total approval time for NDAs approved during calendar year 2006 was approximately thirteen months for standard applications. If the FDA’s evaluation of an NDA submission and the clinical and manufacturing procedures and facilities is not favorable, the FDA may refuse to approve the NDA and issue a Not Approvable letter.

 

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If we obtain regulatory approval for a medicine, this clearance will be limited to those diseases and conditions for which the medicine is effective, as demonstrated through clinical trials. Even if this regulatory approval is obtained, a marketed medicine, its manufacturer and its manufacturing facilities are subject to continual review and periodic inspections by the FDA. Further, the FDA has significant authority to govern the marketing and commercializing of approved drug products, and the FDA may require or recommend that drug developers perform Phase 4 clinical trials even after receipt of FDA approval of a drug product. Discovery of previously unknown problems with a medicine, manufacturer or facility may result in restrictions on the medicine or manufacturer, including costly recalls or withdrawal of the medicine from the market.

We are also subject to various laws and regulations regarding laboratory practices, the experimental use of animals and the use and disposal of hazardous or potentially hazardous substances in connection with our research. In each of these areas, as above, the FDA and other regulatory authorities have broad regulatory and enforcement powers, including the ability to suspend or delay issuance of approvals, seize or recall products, withdraw approvals, enjoin violations, and institute criminal prosecution, any one or more of which could have a material adverse effect upon our business, financial condition and results of operations.

Outside the United States our ability to market the products we develop will also depend on receiving marketing authorizations from the appropriate regulatory authorities. The regulatory approval process in other countries includes all of the risks associated with FDA approval described above.

Intellectual Property

The proprietary nature of, and protection for, our product candidates, processes and know-how are important to our business. We seek patent protection in the United States and internationally for our product candidates and other technology. Our policy is to patent or in-license the technology, inventions and improvements that we consider important to the development of our business. In addition, we use license agreements to selectively convey to others rights to our own intellectual property. We also rely on trade secrets, know-how and continuing innovation to develop and maintain our competitive position. We cannot be sure that patents will be granted with respect to any of our pending patent applications or with respect to any patent applications filed by us in the future, nor can we be sure that any of our existing patents or any patents granted to us in the future will be commercially useful in protecting our technology.

Patent protection has been sought for oritavancin, which we have licensed from Lilly, in the United States and some 50 additional countries worldwide with claims centered on the composition of matter of oritavancin. The key composition of matter patent in the estate with claims directed to oritavancin is United States. Patent No. 5,840,684, with claims to the antibiotic itself, pharmaceutical compositions comprising the antibiotic, methods of treating a bacterial infection using the antibiotic, and methods of making the antibiotic. This patent will expire on November 24, 2015. Due to the delay in development of oritavancin, we believe substantial additional exclusivity—up to an additional five years—may result from the provisions of the Hatch-Waxman legislation in the United States in respect of the composition of matter patent covering oritavancin. The issued oritavancin patents and pending applications are part of a world-wide patent estate that includes almost 600 issued patents and pending applications. Included in the estate are issued patents and pending applications licensed to us in areas including (i) glycopeptide derivatives, (ii) intermediates in the production of oritavancin, (iii) methods of producing oritavancin, (iv) biosynthetic enzymes important in the synthesis of glycopeptides (glucosyl transferases), and (v) methods of treatment.

Additionally, as of March 31, 2007, we owned or had exclusive licenses to 35 issued United States patents and had 6 pending patent applications in the United States. We also owned or had exclusive licenses to 460 granted foreign patents and 95 pending applications in the rest of the world. The claims in these various patents and patent applications are directed to additional compositions of matter of oritavancin, including claims covering product candidates, lead compounds and key intermediates, pharmaceutical compositions, methods of use, and processes for making our compounds along with methods of design, synthesis, selection and use relevant to our research and development programs in particular.

 

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We are seeking to extend patent protection around oritavancin further, including patent applications on methods of treatment involving the use of oritavancin in new indications and methods of producing oritavancin and relevant intermediates for the production thereof.

Commercial Agreements

Lilly License Agreement

In December 2005, in connection with our acquisition from InterMune of assets related to oritavancin, we became a party to a license agreement with Lilly pursuant to which we acquired worldwide license rights to patents and other intellectual property related to oritavancin. Under the license agreement, Lilly granted to us an exclusive, royalty bearing, sublicenseable, worldwide license to make, have made, use, offer to sell, sell and import oritavancin in fields relating to infectious diseases.

Pursuant to the license agreement, we are obligated to make the following milestone payments to Lilly:

 

Milestone

   Required
Payment

First regulatory approval of oritavancin for the treatment of infectious diseases other than complicated skin and skin structure infections and catheter-related bloodstream infections

   $ 10,000,000

Second regulatory approval of oritavancin for the treatment of infectious diseases other than complicated skin and skin structure infections and catheter-related bloodstream infections

   $ 10,000,000

First calendar year in which net sales exceed $210,000,000

   $ 15,000,000

In addition, pursuant to the license agreement, we are obligated to pay Lilly royalties based on our net sales of oritavancin drug product in any calendar year in any jurisdiction in which, under the license agreement, we hold license rights to a valid patent. These royalty obligations are calculated on an aggregate, tiered basis with the royalty percentage increasing based on our realization of qualifying net sales in any calendar year above established thresholds. Under the license agreement, qualifying net sales are sales of oritavancin (or any other product) covered by a patent we license from Lilly, net of customary deductions, in any jurisdiction in which a patent we license from Lilly remains valid. For purposes of calculating qualifying net sales during any particular time period, a sale is deemed to be made at the time the oritavancin (or other) drug product is shipped to the customer, regardless of whether we have received payment at that time. Under the license agreement, we may be obligated to pay the following royalties to Lilly:

 

   

Qualifying annual net

sales up to

$200,000,000

 

Qualifying annual net

sales in excess of

$200,000,000 and up to
$400,000,000

 

Qualifying annual net

sales in excess of

$400,000,000

Annual royalty rate on qualifying net sales

  10%   12%   18%

Under the license agreement with Lilly, our license rights continue on a country-by-country basis until there are no further royalty obligations in a specific country, at which time we will have a fully paid-up, perpetual, irrevocable, exclusive, sublicenseable license to make, have made, use, offer to sell, sell and import oritavancin in fields relating to infectious diseases in the applicable country. The license rights to oritavancin granted to us could revert to Lilly if we do not continue to use our commercially reasonable efforts to develop and commercialize an oritavancin drug product. Prior to the expiration of the license granted under this agreement, either we or Lilly may terminate the agreement upon the other party’s insolvency or uncured material breach of the agreement. Under the license agreement, we have primary responsibility for the maintenance and enforcement of the patents licensed to us by Lilly and are required both to indemnify Lilly in certain circumstances and maintain certain levels of insurance.

 

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InterMune Agreement

In connection with our acquisition of the worldwide rights to oritavancin from InterMune in December 2005, we entered into an asset purchase agreement with InterMune pursuant to which we agreed to pay InterMune a total of up to $25 million in convertible debt and $9 million in cash, such payments to be in the form of both initial payments and future milestone payments. In addition, we agreed to pay Lilly $1 million in cash, which payment was made in January 2006. As of April 15, 2007, due to the consummation of our acquisition of the worldwide rights to oritavancin and our achievement of an initial milestone and our series C financing in January 2007, we had made payments to InterMune that totaled $17.5 million in convertible debt (all of which has converted into shares of our capital stock) and $4 million in cash.

Pursuant to the asset purchase agreement, as amended to date, and the related convertible promissory note we issued to InterMune, as also amended to date, we will issue InterMune additional convertible debt worth $7.5 million, which debt will automatically convert into shares of our capital stock, upon the earlier to occur of (a) our receipt of authorization from the FDA (whether verbal or written) to conduct, or our first dosing of a subject in, a clinical study of oritavancin in the United States, which clinical study is designed to assess the efficacy of oritavancin (excluding for this purpose any clinical study for cSSSI with a single daily intravenous dose of 200 mg/day of oritavancin (or 300 mg/day for patients weighing greater than 110 kg)); or (b) the consummation of our initial public offering. In addition, we are obligated to make a further $5 million cash payment to InterMune if and when we receive from the FDA all approvals necessary for the commercial launch of oritavancin. We have no other milestone or royalty obligations to InterMune in connection with our December 2005 acquisition of the worldwide rights to oritavancin.

ElizaNor License Agreement

On November 8, 2005, we entered into a license agreement with ElizaNor Biopharmaceuticals, Inc. under which, in exchange for future fees and royalty payments, we received a worldwide non-exclusive license to develop and commercialize licensed products based on patents and technology related to therapeutic derivatives of diphosphonates. On June 30, 2006, we entered into an amendment of this agreement to update certain payment terms. We paid ElizaNor a technology access fee of $110,000 in December 2005 and will pay a license fee of approximately $1.1 million consisting of time based payments and contingent payments. We made license fee payments of $55,000 in 2006 and made a license fee payment (including interest) of $245,000 in January 2007. The following milestone payments are also due under the ElizaNor License Agreement (as amended): (i) $100,000 when we file our first investigational new drug application with the FDA for a licensed product, (ii) $250,000 at the time of a successful Phase 2 meeting with the FDA relating to the first licensed product, and (iii) $500,000 payment when we receive FDA approval for the first licensed product.

Our rights to the licensed products under this license agreement with ElizaNor could revert to ElizaNor if we commit a material breach of the agreement. Further, this license agreement will automatically terminate, on a country-by-country basis, upon the expiry of the last to expire patents in the relevant country.

McGill License Agreement

On December 3, 1997, our Québec subsidiary (then the only existing Targanta entity) entered into a license agreement with McGill University pursuant to which it agreed to pay McGill a royalty of 2% of its net revenues during the years 1998 through 2012 arising from products created in reliance on bacterial viruses or phages.

Legal Proceedings

We are not currently a party to any legal proceedings.

 

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Facilities

Our facilities currently consist of approximately 33,600 square feet of laboratory and office facilities located in the United States and Canada. Our corporate headquarters is located in Cambridge, Massachusetts where the administrative responsibilities are staffed for marketing, human resources, finance, and information technology. Our development headquarters, which includes clinical, regulatory, and manufacturing responsibilities, are located in Indianapolis, Indiana. Our research headquarters, which includes microbiology, medicinal chemistry, and animal testing, are located in Montreal, Québec.

We lease approximately 6,100 square feet of office facilities in Cambridge, Massachusetts through October 2009, and 16,000 square feet of laboratory and office facilities in three separate locations in Montreal, Québec. Specifically, in Montreal, Québec, we have a lease for 10,220 square feet through April 2012, 5,102 square feet through September 2007, and 699 square feet through January 2008. We lease approximately 11,500 square feet of office facilities in Indianapolis, Indiana through August 2010.

We believe that these facilities are adequate to meet our current needs. We believe that if additional space is needed in the future, such space will be available on commercially reasonable terms as needed.

Employees

As of June 15, 2007, we employed 77 employees, 23 of whom hold Ph.D., M.D. or Pharm.D. degrees. Fifty-seven of our employees were engaged in research and development activities and twenty are engaged in support administration, including marketing, finance, information systems, facilities and human resources. We consider our relationship with our employees to be good.

 

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MANAGEMENT

Executive Officers and Directors

The following table sets forth certain information about our executive officers and directors, including their ages and positions as of June 15, 2007:

 

Name

   Age   

Position(s)

Mark Leuchtenberger

   51    President, Chief Executive Officer and Director

George Eldridge

   44   

Senior Vice President, Finance and Administration, Treasurer and Assistant Secretary

Pierre Etienne, M.D.

   59    Chief Development Officer

Tom Parr, Ph.D.

   53    Chief Scientific Officer

Garen Bohlin(2)

   59    Director

Jeffrey Courtney(1)(2)

   49    Director

William W. Crouse(1)

   64    Director

Eric M. Gordon, Ph.D.

   61    Director

Dilip Mehta, M.D., Ph.D.

   74    Director

Robin Steele, Esq.(2)

   51    Director

Jay Venkatesan, M.D.(1)

   35    Director

(1)   Member of the Compensation Committee
(2)   Member of the Audit Committee

Executive Officers

Mark W. Leuchtenberger has been our President, Chief Executive Officer and member of our board of directors since September 2006. From March 2002 to August 2006, Mr. Leuchtenberger was President, Chief Executive Officer and a member of the board of directors at Therion Biologics Corporation, a private biopharmaceutical company. In the fourth quarter of 2006, Therion filed a petition under the federal bankruptcy laws, which was rejected. From October 1990 to January 2002, Mr. Leuchtenberger worked for Biogen, Inc. (now Biogen Idec Inc.), a publicly traded biopharmaceutical company, in various capacities, most recently as Vice President, International. From September 1987 to October 1990, Mr. Leuchtenberger worked for Bain and Company, most recently as a Senior Consultant. Mr. Leuchtenberger is on the Board of Directors of Epix Pharmaceuticals, Inc., where he is the chair of the Compensation Committee. Mr. Leuchtenberger received a M.B.A. from the Yale School of Management and a B.A. in English from Wake Forest University.

George A. Eldridge has been a Senior Vice President, Finance and Administration and Treasurer since September 2006 and Assistant Secretary since December 2006. From September 2002 to September 2006, Mr. Eldridge was Senior Vice President and Chief Financial Officer at Therion Biologics Corporation, a private biopharmaceutical company. In the fourth quarter of 2006, Therion filed a petition under the federal bankruptcy laws, which was rejected. From August 2000 to May 2002, Mr. Eldridge was the Vice President of Finance and Chief Financial Officer of Curis, Inc., a publicly traded biopharmaceutical company and a successor company to Ontogeny, Inc. From April 1996 to August 2000, Mr. Eldridge was Vice President of Finance at Ontogeny, Inc., which merged with Creative BioMolecules, Inc. and Reprogenesis, Inc. to form Curis. From April 1993 to April 1996, Mr. Eldridge was Vice President, Corporate Development and Finance for Boston Life Sciences, Inc. From August 1990 to March 1993, Mr. Eldridge was an investment banker at Kidder Peabody & Co., Inc. Mr. Eldridge received a M.B.A. from the University of Chicago and a B.A. in Government and Economics from Dartmouth College.

Pierre E. Etienne, M.D. has served as our Chief Development Officer since September 2006. Dr. Etienne joined Targanta Therapeutics Inc., our Montreal, Canada based subsidiary (formerly PhageTech Inc.) as Chief Executive Officer in June 2003, serving in that role until September 2006. In addition, Dr. Etienne served as our

 

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Chief Executive Officer from its formation in December 2005 until September 2006. From 1996 to 2003, Dr. Etienne was a Vice President, World Wide Clinical Study Management at Pfizer Inc., a publicly traded biopharmaceutical company, where he was accountable for the clinical execution of all Phase 2 and Phase 3 trials. From 1989 to 1992, Dr. Etienne led the experimental medicine group at Pfizer US Laboratories in Groton, CT. From 1992 to 1996, Dr. Etienne led Pfizer’s United States early clinical research group. Dr. Etienne received an M.D. degree from Université de Liège, Belgium and trained in neurochemistry and psychiatry at McGill University in Montreal, Canada.

Thomas R. Parr Jr., Ph.D. has served as our Chief Scientific Officer since January 2005. From May 2003 to December 2004, Dr. Parr was Vice President of Research at Adaptive Therapeutics, a private biopharmaceutical company. From May 2002 to May 2003, Dr. Parr served in various capacities at Embiosis Pharmaceuticals, formerly MicroGenomics, Inc., a private biopharmaceutical company, most recently as its President and acting Chief Executive Officer. From August 2001 to March 2002, Dr. Parr was Senior Director of Microbiology at Xenogen Corporation, a private biopharmaceutical company. From May 2000 to August 2001, Dr. Parr was Senior Director of Microbiology at Intrabiotics Pharmaceuticals, Inc., a private biopharmaceutical company. From 1997 to 2000, Dr. Parr was a Senior Microbiologist at Lilly. During his career, Dr. Parr has been involved in the development of several marketed and late-stage clinical candidates for both antibacterial and antifungal applications. Dr. Parr received a Ph.D. degree in Microbiology and Infectious Diseases from The University of Calgary, a M.A. in Philosophy from the University of Calgary and a B.A. in Biology and Philosophy from the University of Minnesota.

Directors

Garen Bohlin has served as a member of our board of directors since May 2007. Mr. Bohlin is currently the Chief Operating Officer of Sirtris Pharmaceuticals, Inc., having served in that capacity since 2006. Prior to joining Sirtris, Mr. Bohlin served as President and Chief Executive Officer of Syntonix Pharmaceuticals, Inc. from 1999 to 2005. Prior to Syntonix, which was acquired by Biogen Idec in 2006, Mr. Bohlin spent 14 years in executive management at Genetics Institute, Inc. In his last role at Genetics Institute, Mr. Bohlin served as Executive Vice President with responsibility for most of the non-scientific areas of the company that comprised approximately half of the company’s then 1,600 employees. Mr. Bohlin played a leading role in structuring and implementing a strategic alliance with American Home Products (now Wyeth) that resulted in the eventual acquisition of Genetics Institute at an implied valuation of approximately $3 billion. Prior to Mr. Bohlin’s tenure at Genetics Institute, he was a partner at Arthur Andersen & Co., where he spent 13 years. Mr. Bohlin currently serves as a director and the chair of the audit committee of Acusphere, Inc.

Jeffrey Courtney has served as a member of our board of directors since December 2005. Mr. Courtney is a General Partner with VenGrowth Private Equity Partners Inc., where he has been since 2002. Mr. Courtney has more than 20 years of experience in the life sciences industry with in-depth expertise across multiple therapeutic areas in quality assurance, regulatory affairs, business development, marketing, and sales. Mr. Courtney has worked with both emerging and established life sciences firms, particularly within the sub-verticals of medical devices and pharmaceuticals. Mr. Courtney has served as a director on the board of many Canadian and United States life science companies, including Aegera Therapeutics, Avalon Pharmaceuticals and Exemias Therapeutics. Mr. Courtney received a B.Sc. in Microbiology from the University of Guelph.

William W. Crouse has served as a member of our board of directors since December 2005. Mr. Crouse is a General Partner of HealthCare Ventures, a firm that he joined in 1994. Prior to joining HealthCare Ventures, Mr. Crouse was Worldwide President of Ortho Diagnostic Systems and a Vice President of Johnson & Johnson International. Before joining Johnson & Johnson, Mr. Crouse was Division Director, DuPont Pharmaceuticals. Mr. Crouse serves as a director on the board of directors of each of The Medicines Company and ULURU, Inc. Mr. Crouse received a M.B.A. from Pace University and a B.S. in Business Administration from Lehigh University.

 

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Eric M. Gordon Ph.D. has served as a member of our board of directors since January 2007. Dr. Gordon is a partner at Skyline Ventures, where he has been since 2002. From 1998 to late 2002, Dr. Gordon worked at Sunesis Pharmaceuticals, a publicly traded biopharmaceutical company, in various capacities, most recently as Senior Vice President of Research. From 1996 to 1998, Dr. Gordon was scientific co-founder, President and Chief Scientific Officer of Versicor (predecessor of Vicuron Pharmaceuticals, which was acquired by Pfizer in 2005). In 1992, he became Vice President of Research and Director of Chemistry at Affymax in Palo Alto and held that role until the company was sold to GlaxoSmithKline plc in 1995. Previously, Dr. Gordon was Head of Medicinal Chemistry at Bristol-Myers Squibb Company in Princeton, where he worked for 18 years. Dr. Gordon is on the Scientific Advisory Boards of Directors of the Cystic Fibrosis Foundation and the Organization for One World Health, as well as Sirtris Pharmaceuticals, Inc., Sunesis Pharmaceuticals Inc. and Cytokinetics Inc. In 1997, Dr. Gordon was elected a Fellow of the American Association for the Advancement of Science. Dr. Gordon received a Ph.D. and a M.S. in Medicinal Chemistry from the University of Wisconsin in Madison and conducted post-doctoral work at Yale University.

Dilip Mehta, M.D., Ph.D. has served as a member of our board of directors since December 2005. Dr. Mehta is a venture partner at Radius Ventures and has been so since June 2004. Dr. Mehta is the former Senior Vice President of United States Clinical Research at Pfizer Inc., a publicly traded biopharmaceutical company. In this role, Dr. Mehta was responsible for clinical research (Phase 1, 2 and 3), including the design and implementation of clinical protocols, statistical analysis and data processing, and submissions of new drug applications. Dr. Mehta currently serves on the Psychopharmacology Advisory Committee of the United States Food and Drug Administration, is a member of the Board of Directors of Spectrum Pharmaceuticals, Inc., Avaan Therapeutics, Inc., and Bharat Serums & Vaccines Limited (located in India). Dr. Mehta received an M.D., M.B.B.S., and a Ph.D. from the University of Bombay.

Robin Steele has served as a member of our board of directors since December 2005. Ms. Steele is currently Senior Vice President, General Counsel and Corporate Secretary at InterMune, Inc., a publicly traded biopharmaceutical company, where she has been since May 2004. From 1998 to 2003, Ms. Steele worked with Elan Pharmaceuticals, Inc., a global pharmaceutical company headquartered in Dublin, Ireland, most recently as Vice President, Commercial and Legal Affairs. Prior to joining Elan, Ms. Steele was in private practice and served as outside counsel to a variety of life science and technology based companies in the Bay Area. Ms. Steele received a J.D. from Hastings College of the Law, University of California, San Francisco, a L.L.M. in Taxation from New York University School of Law and a B.A. in Biology from University of Colorado, Boulder.

Jay Venkatesan, M.D. has served as a member of our board of directors since January 2007. Dr. Venkatesan is a Director at Brookside Capital Partners, where he has been since July 2002. From July 1995 through August 1996, Dr. Venkatesan worked at Patricof & Co. Ventures with a focus on life sciences investments. Dr. Venkatesan also worked at McKinsey & Company from August 1993 through June 1995, where he consulted companies in the pharmaceutical, media and information technology industries. Dr. Venkatesan received an M.D. from the University of Pennsylvania School of Medicine, a M.B.A. from the Wharton School of the University of Pennsylvania and a B.A. from Williams College.

 

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Other Management Members

The following table sets forth certain information about other members of our management team, including their ages and positions as of June 15, 2007:

 

Name

   Age   

Position(s)

Christian Bélisle

   48   

Vice President, Finance & Administration and Secretary

Gayle C. Fischer

   56    Vice President, Marketing

Paul D. Gesellchen, Ph.D.

   58    Vice President, Regulatory Affairs

Stanley W. Merrill

   48    Vice President, Human Resources

Roger Miller

   57    Vice President, Operations and Manufacturing and Indianapolis Site Head

Margaret Wasilewski, M.D.

   50   

Vice President, Clinical Development and Medical Science Team Leader

Other Management Members

Christian Bélisle has served as our Vice President, Finance since 2002 and Secretary since December 2005. From 1995 to 2002, Mr. Bélisle worked for the Solidarity Fund QFL, a venture capital firm, where he was responsible for making business investments in biotechnology companies and served on the board of directors for several of those firms. Mr. Bélisle is a chartered accountant and member of the Order of Chartered Accountants of Québec. Mr. Bélisle received a B. Admin. Degree from the University of Sherbrooke.

Gayle Crick Fischer, R.Ph. has served as our Vice President, Marketing since March 2006. From 1978 through 2006, Ms. Fischer worked at Lilly and held various positions in both its United States and international operations, including management roles in sales, marketing, new product planning and business development. Most recently, Ms. Fischer was a Director, Marketing Advisor for Lilly. Ms. Fischer received a M.M. (M.B.A.) from the University of Michigan (Rackham School of Graduate Studies) and a B.S in Pharmacy from the University of Michigan.

Paul D. Gesellchen, Ph.D. has served as our Vice President, Regulatory Affairs since September 2006. From October 1977 to September 2006, Dr. Gesellchen held various positions at Lilly, including 13 years as Research Scientist, directing a laboratory developing peptides as new drug candidates, and 16 years in United States Regulatory Affairs, most recently as Senior Scientific Director. Dr. Gesellchen received a Ph.D. in Pharmaceutical Chemistry from the University of Wisconsin, Madison, a B.A. in Chemistry from the University of Nebraska, Lincoln, and is regulatory affairs certified.

Stanley W. Merrill has served as our Vice President, Human Resources since March 2007. From July 2004 to March 2007, Mr. Merrill held various positions at Acambis, Inc., a publicly traded biopharmaceutical company, most recently as Director of Human Resources and Acting Vice President, Human Resources. From February 2002 to July 2004, Mr. Merrill was President and Chief Executive Officer at Merrill Placements, Inc., a private staffing company working almost exclusively in the biopharmaceutical industry. Mr. Merrill received a M.B.A. from the Babson College and a B.A. in Geology from the University of Vermont.

Roger D. Miller has served as our Vice President, Operations and Manufacturing since January 2006 and, since June 2007, has also served as Site Head for our Indianapolis, Indiana facility. From December 2004 to January 2006, Mr. Miller served as Founder of AcquiRight, Due Diligence Partners, a consulting business that provided service to pharmaceutical business development professionals. Prior to December 2004, Mr. Miller held a variety of positions at Lilly since joining in November 1968. Mr. Miller served his early career in Lilly’s Research and Development departments and moved into Lilly’s Manufacturing department in 1982. Mr. Miller held director level positions leading groups in the various functional areas including: Technical Services, Manufacturing, Quality Control, Third Party Supply Services and Corporate Due Diligence, and most recently, Quality Assurance. From April 1997 to the present, Mr. Miller has served on the board of directors of Baptist

 

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Homes of Indiana, a not-for-profit continuing care retirement community based in Indiana. Mr. Miller received a M.S. in Physical Chemistry from Indiana University Purdue University at Indianapolis (IUPUI), a M.S. (M.B.A.) in Management from Purdue University and a B.A. in Chemistry from IUPUI.

Margaret Wasilewski, M.D. has served as our Vice President, Clinical Development and Medical Science Team Leader since January 2006. From 2003 to January 2006, Dr. Wasilewski was the President of ID Remedies LLC, a pharmaceutical drug development consulting company. From 1996 to 2003, Dr. Wasilewski held various positions at Lilly, most recently as Senior Clinical Research Physician, Infectious Disease and Oritavancin Product Team Lead Physician. Dr. Wasilewski received an M.D. from Tufts University and is board certified in Infectious Diseases and Internal Medicine. Dr. Wasilewski also received a M.S. in Nutrition from the University of California, Berkeley and a B.A. in Chemistry from Douglass College.

Board of Directors

We currently have eight directors, each of whom was elected as a director under board composition provisions of a stockholders agreement, which will be terminated upon the closing of this offering. Upon the termination of these provisions, there will be no further contractual obligations regarding the election of our directors. Our directors hold office until their successors have been elected and qualified or until the earlier of their resignation or removal.

Following the offering, the board of directors will be divided into three classes with members of each class of directors serving for staggered three-year terms. The board of directors will consist of              Class I directors (currently             ,              and             ),              Class II directors (currently             ,              and             ) and              Class III directors (currently              and             ), whose initial terms will expire at the annual meetings of stockholders held in 2008, 2009 and 2010, respectively. Our classified board could have the effect of making it more difficult for a third party to acquire control of us.

Pursuant to the terms of his employment agreement, Mark Leuchtenberger, our President and Chief Executive Officer, will, subject to election by our stockholders, continue to serve as a member of our board of directors.

Board Committees

Our board of directors has established an audit committee, a compensation committee and a nominating and corporate governance committee. The composition and functioning of all of our committees complies with the rules of the SEC and The Nasdaq Global Market that are currently applicable to us and we intend to comply with additional requirements to the extent that they become applicable to us.

Audit committee.

Garen Bohlin, Jeff Courtney and Robin Steele currently serve on the audit committee. Mr. Bohlin serves as the Chair of the audit committee. The audit committee’s responsibilities include, but are not limited to:

 

   

appointing, approving the compensation of, and assessing the independence of our independent auditor;

 

   

overseeing the work of our independent auditor, including through the receipt and consideration of certain reports from the independent auditor;

 

   

resolving disagreements between management and our independent auditor;

 

   

pre-approving all auditing and permissible non-audit services (except de minimus non-audit services), and the terms of such services, to be provided by our independent auditor;

 

   

reviewing and discussing with management and the independent auditors our annual and quarterly financial statements and related disclosures;

 

   

coordinating the oversight of our internal control over financial reporting, disclosure controls and procedures and code of business conduct and ethics;

 

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discussing our risk management policies;

 

   

establishing policies regarding hiring employees from the independent auditor and procedures for the receipt and retention of accounting related complaints and concerns;

 

   

meeting independently with our independent auditors and management; and

 

   

preparing the audit committee report required by SEC rules to be included in our proxy statements.

Upon the closing of this offering, all of the members of the audit committee will be “independent” under the applicable rules of The Nasdaq Global Market and the SEC.

Compensation committee.

Jeffrey Courtney, William Crouse and Jay Venkatesan currently serve on the compensation committee. Mr. Crouse serves as the Chair of the compensation committee. The compensation committee’s responsibilities include, but are not limited to:

 

   

annually reviewing and approving corporate goals and objectives relevant to the compensation of our Chief Executive Officer;

 

   

evaluating the performance of our Chief Executive Officer in light of such corporate goals and objectives and determining the compensation of our Chief Executive Officer;

 

   

determining the compensation of our other executive officers;

 

   

overseeing an evaluation of our senior executives;

 

   

overseeing and administering our incentive-based compensation plans and equity-based compensation plans; and

 

   

reviewing and making recommendations to the board with respect to director compensation.

Upon the closing of this offering, all of the members of the compensation committee will be “independent” under the applicable rules of The Nasdaq Global Market.

Nominating and corporate governance committee.

            ,              and              currently serve on the nominating and corporate governance committee.              serves as the Chair of the nominating and corporate governance committee. The nominating and corporate governance committee’s responsibilities include, but are not limited to:

 

   

developing and recommending to the board criteria for board and committee membership;

 

   

establishing procedures for identifying and evaluating director candidates including nominees recommended by stockholders;

 

   

identifying individuals qualified to become board members;

 

   

establishing procedures for stockholders to submit recommendations for director candidates;

 

   

recommending to the board the persons to be nominated for election as directors and to each of the board’s committees;

 

   

developing and recommending to the board a set of corporate governance guidelines;

 

   

serving as the Qualified Legal Compliance Committee in accordance with Section 307 of the Sarbanes-Oxley Act of 2002; and

 

   

overseeing the evaluation of the board and management.

Upon the closing of this offering, all of the members of the nominating and corporate governance committees will be “independent” under the applicable rules of The Nasdaq Global Market.

 

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Compensation Committee Interlocks and Insider Participation

None of our executive officers serves as a member of the board of directors or compensation committee, or other committee serving an equivalent function, of any other entity that has one or more of its executive officers serving as a member of our board of directors or compensation committee. None of the current members of our compensation committee has ever been an employee of the Company.

Executive Officers

Each of our executive officers has been elected by our board of directors and serves until his or her successor is duly elected and qualified.

Executive Compensation

Compensation Discussion and Analysis

Objectives of Executive Compensation Program

The compensation committee of our board of directors has responsibility for establishing and monitoring our executive compensation program. The primary objectives of the compensation committee with respect to executive compensation are to attract, retain and motivate executive officers who will make important contributions to the achievement of our business goals and success. The compensation committee believes that the most effective executive compensation program rewards the achievement of annual, long-term and strategic goals of our company. Our executive compensation program has been designed to link short and long-term cash and equity incentives to the achievement of measurable corporate and individual performance objectives, and to align executives’ incentives with stockholder value creation. To achieve these objectives, the compensation committee has maintained, and expects to further implement, compensation plans that tie a substantial portion of executive officers’ overall compensation to our research, development, and operational performance.

As a privately held company, we have not historically retained compensation consultants to review our policies and procedures relating to executive compensation. The compensation committee, with the input of management, develops our compensation plans by utilizing publicly available compensation data and subscription compensation survey data for national and regional companies in the biopharmaceutical industry. The compensation committee also considers competitive market practices based on the experience of the members of the compensation committee and through contacts at executive search firms. We believe that the practices of national and regional companies in the biopharmaceutical industry provide us with appropriate compensation benchmarks, because these companies operate in the same industry as us, have similar organizational structures and tend to compete with us for executives and other employees. For benchmarking executive compensation, we typically review the compensation data we have collected from a number of biopharmaceutical companies, as well as a subset of the data from those companies that have a similar number of employees at a similar stage of development as our company.

Based on these overall objectives and philosophy, the compensation committee has designed an executive compensation program that generally seeks to bring base salaries and total executive compensation in line with the companies with a similar number of employees represented in the compensation data we review. The program allows the compensation committee to determine each component of an executive’s compensation based on a number of factors, including (a) the executive’s overall experience and skills (with an emphasis on particular industry experience), (b) the executive’s position and responsibilities in comparison to other executives at the company and (c) the demand within our market for the executive’s skills relative to other executives in our industry.

The compensation committee has also implemented an annual performance management program, under which annual corporate goals are proposed by management and approved by the board of directors at the end of each calendar year for the following year. These corporate goals include the achievement of qualitative and quantitative operational and financial targets and pre-defined research and development milestones. Each goal is

 

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weighted as to importance by the board of directors. The individual performance of our executive officers is based on the level of achievement of corporate goals including those related to their respective areas of responsibility as well as on individual professional development, including an assessment of management, communication and leadership skills. Annual salary increases, annual bonuses, and annual stock option awards granted to our executive officers are tied to the achievement of the corporate goals. The board of directors, generally based on a recommendation of the compensation committee, approves all salary increases, as well as bonuses and stock option awards, if any, for executive officers. Annual base salary increases, annual stock option awards, and annual bonuses, to the extent granted, are generally implemented during the first calendar quarter of the year.

Components of our Executive Compensation Program

The principal components of our executive compensation program are base salary, annual bonus, and long-term incentives. Our compensation committee believes that each component of executive compensation must be evaluated and determined with reference to competitive market data, individual, department, and corporate performance, our recruiting and retention goals, internal equity and consistency, and other information we deem relevant. We believe that in the biopharmaceutical industry stock option awards are a primary motivator in attracting and retaining executives, in addition to salary and cash incentive bonuses.

The components of our compensation package are as follows:

Base Salary

We provide base salaries for our executives to compensate them for their services rendered during the fiscal year. Base salary ranges for named executive officers are established based on their position and scope of responsibilities, their prior experience and training, and competitive market compensation data we review for similar positions in our industry.

Base salaries are reviewed annually as part of our performance management program and increased for merit reasons, based on the executive’s success in meeting or exceeding individual performance objectives and an assessment of whether significant corporate goals were achieved. The individual performance of our executive officers is based on the level of achievement of corporate goals including those related to their respective areas of responsibility as well as on basic skills, including management, communication and leadership ability. Our corporate goals target the achievement of certain research, development, and operational milestones. Additionally, we may adjust base salaries throughout the year for promotions or other changes in the scope or breadth of an executive’s role or responsibilities.

Annual Bonus

A significant element of the cash compensation of our executive officers is an annual performance-based cash bonus. An executive’s target bonus is generally set as a percentage of base salary to reward strong performance and retain employees in a competitive labor market. Bonuses are based on the achievement of significant company goals, including research, development, financial and operational milestones, as well as the achievement of individual goals. Currently, all executives, other than our Chief Executive Officer are eligible for annual performance-based cash bonuses with a target of 25% of their base salaries. In its discretion, the compensation committee may, however, award bonus payments to our executives above or below the target amounts. Our Chief Executive Officer is eligible for an annual performance-based cash bonus with a target of 50% of his base salary. Additionally, the board of directors or the compensation committee, may increase or decrease an executive’s bonus payment (above or below the target) based on its assessment of an executive’s individual performance during a given year.

Long-term incentives

Our equity-based long term incentive program is designed to align executives’ long term incentives with stockholder value creation. We believe that long-term participation by our executive officers in equity-based

 

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awards is a critical factor in the achievement of long-term company goals and business objectives. Our 2005 Stock Option Plan allows the grant to executive officers of stock options, and we typically make an initial equity award of stock options to new employees and annual equity grants as part of our overall compensation program. Annual grants of options to our executive officers other than our Chief Executive Officer are recommended by the Chief Executive Officer and finalized by the compensation committee and/or the board of directors. Annual grants of options to our Chief Executive Officer are made by the compensation committee and/or the board of directors.

Initial stock option awards.  We typically make an initial award of stock options to new executives in connection with the commencement of their employment. These grants generally have an exercise price equal to the fair market value of our common stock on the grant date and a vesting schedule of 25% on the first anniversary of the date of hire and monthly thereafter for the next three years. The initial stock option awards are intended to provide the executive with incentive to build value in the organization over an extended period of time and to maintain competitive levels of total compensation. The size of the initial stock option award is determined based on numerous factors, including the executive’s skills and experience, the executive’s responsibilities with us, internal equity and an analysis of the practices of national and regional companies in the biopharmaceutical industry similar in size to us.

Annual stock option awards.  Our practice is to make annual stock option awards as part of our overall performance management program. We intend that the annual aggregate value of these awards will be set near competitive median levels for companies represented in the compensation data we review. As is the case when the amounts of base salary and initial equity awards are determined, a review of all components of the executive’s compensation is conducted when determining annual equity awards to ensure that an executive’s total compensation conforms to our overall philosophy and objectives.

Other Compensation

We maintain broad-based benefits and perquisites that are provided to all eligible employees, including health insurance, life and disability insurance, dental insurance and paid vacation.

Termination Based Compensation

Severance.  Upon termination of employment, our executive officers are entitled to receive severance payments under their employment agreements. In determining whether to approve and setting the terms of such severance arrangements, the compensation committee recognizes that executives, especially highly ranked executives, often face challenges securing new employment following termination. Severance for termination without cause for executive officers, other than our Chief Executive Officer, ranges from six to twelve months of base salary. Our Chief Executive Officer’s employment agreement provides severance of 12 months of base salary if his employment is terminated without cause; provided that the payment period shall be extended from 12 months to 18 months if Mr. Leuchtenberger’s termination occurs at a time when he has been employed by us for at least two years. We believe that our Chief Executive Officer’s severance package is in line with severance packages offered to chief executive officers of the companies of similar size to us represented in the compensation data we reviewed.

Acceleration of vesting of equity-based awards.  In the event of a change of control, as defined in the employment agreements of our executive officers, certain provisions allow for acceleration of equity awards in case the executive officer’s employment is terminated for certain reasons after a change in control. See “—Employment Agreements” and “—Potential Payments upon Termination or Change of Control” below for a detailed discussion of these provisions.

Tax Considerations

Section 162(m) of the Internal Revenue Code of 1986, as amended, generally disallows a tax deduction for compensation in excess of $1.0 million paid to our chief executive officer and our four other most highly paid

 

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executive officers. Qualifying performance-based compensation is not subject to the deduction limitation if specified requirements are met. We generally intend to structure the performance-based portion of our executive compensation, when feasible, to comply with exemptions in Section 162(m) so that the compensation remains tax deductible to us. Our board of directors may, in its judgment, authorize compensation payments that do not comply with the exemptions in Section 162(m) when it believes that such payments are appropriate to attract and retain executive talent.

Summary Compensation Table

The following table shows the compensation paid or accrued during the fiscal year ended December 31, 2006 to (1) our current Chief Executive Officer (Mark Leuchtenberger), and our previous Chief Executive Officer (Pierre Etienne), (2) our current principal financial officer (George Eldridge), and our previous principal financial officer (Christian Bélisle) and (3) our other most highly compensated executive officer. Amounts included under Options Awards below represent the fair value of the award calculated under SFAS 123(R).

 

Name and Principal Position

   Year    Salary
($)
    Bonus
($)
   Option
Awards
($)(1)
   All Other
Compensation
($)(2)
    Total
($)

Mark Leuchtenberger(3),

Director, President and Chief

Executive Officer

   2006    $ 100,685 (5)     —      $ 1,000    $ 541 (7)   $ 102,226

Pierre Etienne(3),

Chief Development Officer

   2006    $ 278,356     $ 95,000    $ 37,727    $ 1,732 (7)   $ 412,815

George Eldridge(4),

Senior Vice President, Finance

& Administration, Treasurer and Assistant Secretary

   2006    $ 59,068 (6)     —      $ 297    $ 142 (7)   $ 59,507

Christian Bélisle(4),

Vice President,

Finance and Secretary

   2006    $ 149,573     $ 23,900    $ 4,723    $ 1,144 (8)   $ 179,340

Thomas Parr,

Chief Scientific Officer

   2006    $ 220,000     $ 55,000    $ 9,728    $ 18,275 (9)   $ 303,003

(1)   This column shows the amounts recognized in 2006 for financial statement reporting purposes under SFAS 123(R), without regard to any estimate of forfeitures related to service-based vesting conditions. The exercise price of each of these grants was well in excess of the fair value of our common stock on the date of grant, and as a result, the SFAS 123(R) value on a per share basis was determined to be $1.50. See Note 14 to our Consolidated Financial Statements, “Stock Option Plans,” included below in this prospectus, for a discussion of the assumptions used in calculating the SFAS 123(R) expense. During 2006, options to purchase 617 shares of our common stock were either forfeited or expired, none of which included options to purchase shares of our common stock that were held by executive officers and directors.
(2)   No named executive officer other than Dr. Parr received perquisites or personal benefits during 2006 valued at or in excess of $10,000.
(3)   Dr. Etienne served as the company’s Chief Executive Officer and President until September 18, 2006, the date on which Mr. Leuchtenberger joined the company as its President and Chief Executive Officer. Mr. Leuchtenberger is also the President of each of the company’s two Canadian subsidiaries. Since September 18, 2006, Dr. Etienne has held the position of Chief Development Officer of the company.
(4)  

Christian Bélisle is the company’s Vice President, Finance and Secretary and served as the company’s Chief Accounting Officer until September 25, 2006, the date on which Mr. Eldridge joined the company as its Senior Vice President, Finance & Administration, Treasurer and Chief Accounting Officer. Mr. Eldridge also serves as the Assistant Secretary of the company. Since September 25, 2006, Mr. Bélisle has held the

 

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title of Vice President, Finance and Secretary of the company. Mr. Bélisle also serves as the Treasurer and Secretary of the company’s two Canadian subsidiaries.

(5)   Mr. Leuchtenberger’s rate of base salary for 2006 was $350,000.
(6)   Mr. Eldridge’s rate of base salary for 2006 was $220,000.
(7)   Comprised of amounts paid by the company in respect of life insurance premiums.
(8)   Includes $214 paid by the company as a contribution to a retirement plan and $931 paid by the company in respect of life insurance premiums.
(9)   Includes $611 paid by the company in respect of life insurance premiums, a $7,500 car allowance and a $10,164 housing allowance.

Grants of Plan-Based Awards

The following table shows information regarding grants of equity awards during the fiscal year ended December 31, 2006 held by the executive officers named in the Summary compensation table.

 

Name

   Grant Date    Number of Securities
Underlying Options (#)(1)
   Exercise or Base
Price of Option
Awards ($/Sh)(2)
   Grant Date Fair
Value of Stock and
Option Awards(3)

Mark Leuchtenberger

   10/17/06    10,666    $ 70.50    $ 16,000

Pierre Etienne

   3/29/06    2,666    $ 36.00    $ 4,000
   11/06/06    1,333    $ 70.50    $ 2,000

George Eldridge

   10/17/06    3,166    $ 70.50    $ 4,750

Christian Bélisle

   3/29/06    333    $ 36.00    $ 500

Thomas Parr

   3/29/06    1,666    $ 36.00    $ 2,500

(1)   All share numbers reflect the 1:150 reverse stock split effected on January 31, 2007.
(2)   All exercise prices reflect the 1:150 reverse stock split effected on January 31, 2007.
(3)   This column reflects the SFAS 123(R) grant date fair value of each award made to a named executive officer.

In connection with replacement option grants made in May 2007, all of the foregoing options were tendered for cancellation. See “—Outstanding Equity Awards following May 8, 2007 Option Grant and Cancellation of Existing Options” and “—May 2007 Equity Grants” below.

Grants of Plan-Based Awards Outstanding following May 8, 2007 Option Grant and Cancellation of Existing Options

The following table shows information regarding grants of equity awards made on May 8, 2007, of which certain grants replace all options previously granted to the executive officers named in the summary compensation table. As further discussed under the headers “—Outstanding Equity Awards following May 8, 2007 Option Grant and Cancellation of Existing Options” and “—May 2007 Equity Grants” below, in order to receive these option grants, the recipients were required to agree to the cancellation of all outstanding stock options previously granted to them by either the Company or either of its subsidiaries.

 

Name

   Grant Date    Number of Securities
Underlying Options (#)
   Exercise or Base
Price of Option
Awards ($/Sh)
   Grant Date Fair
Value of Stock and
Option Awards(1)

Mark Leuchtenberger

   5/8/07    538,000    $ 5.00    $ 1,558,335

Pierre Etienne

   5/8/07    300,000    $ 5.00    $ 863,954

George Eldridge

   5/8/07    115,000    $ 5.00    $ 332,821

Christian Bélisle

   5/8/07    20,000    $ 5.00    $ 57,128

Thomas Parr

   5/8/07    150,000    $ 5.00    $ 433,243

(1)   This column reflects the SFAS 123(R) grant date fair value of each award made to a named executive officer.

 

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The terms of each executive officer’s compensation are derived from our employment agreements entered into between us and them and annual performance reviews conducted by the compensation committee, in the case of Mr. Leuchtenberger, and by the compensation committee after obtaining Mr. Leuchtenberger’s recommendations in the case of the other executive officers. Annual base salary increases, annual stock option awards and cash bonuses, if any, for Mr. Leuchtenberger are determined by the compensation committee. Mr. Leuchtenberger recommends annual base salary increases, annual stock option awards and cash bonuses, if any, for the other executive officers, which are reviewed and approved by the compensation committee.

Employment Agreements

Mark Leuchtenberger.  Pursuant to an agreement dated September 12, 2006 between us and Mr. Leuchtenberger, we agreed to employ Mr. Leuchtenberger as our President and Chief Executive Officer. We also agreed that so long as Mr. Leuchtenberger continues to serve as our President and Chief Executive Officer, subject to election by the stockholders, he will serve as a member of the board of directors. Under this agreement, Mr. Leuchtenberger’s initial annual base salary is $350,000 per year, subject to annual review and adjustment from time to time at the discretion of the board of directors. Mr. Leuchtenberger is eligible to receive an annual performance bonus of up to 50% of his base salary based upon achievement of certain milestones and performance objectives to be mutually agreed upon by the Board of Directors and Mr. Leuchtenberger. In connection with Mr. Leuchtenberger’s commencement of employment, the company made an initial grant of options to purchase 10,666 shares of common stock at an exercise price of $70.50 per share pursuant to the terms and conditions of the company’s 2005 Stock Option Plan, which option vests quarterly over four years subject to acceleration in certain circumstances described below. As a result of the consummation of our Series C financing in January and February 2007, Mr. Leuchtenberger’s percentage ownership of the company was significantly diluted, and on May 8, 2007, we made an additional grant of options to Mr. Leuchtenberger to purchase 538,000 shares of common stock, which option vests quarterly over four years subject to acceleration in certain circumstances described below, at an exercise price of $5.00 per share. By accepting this new option grant, Mr. Leuchtenberger agreed to tender for cancellation all options previously granted to him by the company. As a condition of employment, Mr. Leuchtenberger has entered into a non-competition, non-solicitation and non-disclosure agreement pursuant to which he has agreed not to compete with the company or to solicit customers or employees of the company for a period of 12 months after the termination of his employment.

If Mr. Leuchtenberger’s employment is terminated without cause by the company or due to his death or disability or he terminates his employment for good reason within 24 months following a change of control, he will receive the following severance benefits following his employment termination: (a) base salary for a period of 12 months; provided that the payment period shall be extended from 12 months to 18 months if Mr. Leuchtenberger’s termination occurs at a time when he has been employed by the company for at least two years; (b) unless termination is due to his death, that portion of any bonus (on a pro rated basis) that the board of directors, in its discretion, otherwise would have awarded to him as of such date; and (c) reimbursement of Mr. Leuchtenberger or his dependents for the cost of COBRA premiums (less the employee portion thereof) during the 12 or 18 month severance period. In addition, in the event that Mr. Leuchtenberger’s employment is terminated for any reason at any time within the two years following a change of control, he would become vested in 100% of his then unvested options. We may also adjust the timing and/or amount of any payment or benefit due to Mr. Leuchtenberger to avoid the imposition of an excise tax upon him pursuant to Section 4999 of the Internal Revenue Code.

George Eldridge.  Pursuant to an agreement dated September 25, 2006 between us and Mr. Eldridge, we agreed to employ Mr. Eldridge as our Senior Vice President, Finance & Administration and Treasurer. Under this agreement, Mr. Eldridge’s annual base salary is $250,000 per year, subject to annual review and adjustment from time to time at the discretion of the board of directors, and shall automatically be increased to $275,000 upon consummation of this offering. Mr. Eldridge is eligible to receive an annual performance bonus of up to 25% of his base salary based upon achievement of certain milestones and performance objectives to be mutually agreed upon by the Board of Directors and Mr. Eldridge. In connection with Mr. Eldridge’s commencement of

 

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employment, the company made an initial grant of options to purchase 3,166 shares of common stock at an exercise price of $70.50 per share pursuant to the terms and conditions of the company’s 2005 Stock Option Plan, which option vests quarterly over four years subject to acceleration in certain circumstances described below. As a result of the consummation of our Series C financing in January and February 2007, Mr. Eldridge’s percentage ownership of the company was significantly diluted, and on May 8, 2007, we made an additional grant of options to Mr. Eldridge to purchase 115,000 shares of common stock, which option vests quarterly over four years subject to acceleration in certain circumstances described below, at an exercise price of $ 5.00 per share. By accepting this new option grant, Mr. Eldridge agreed to tender for cancellation all options previously granted to him by the company.

As a condition of employment, Mr. Eldridge has entered into a non-competition, non-solicitation and non-disclosure agreement pursuant to which he has agreed not to compete with the company or to solicit customers or employees of the company for a period of 12 months after the termination of his employment. If Mr. Eldridge’s employment is terminated without cause by the company or due to his death or disability or he terminates his employment for good reason within 24 months following a change of control, he will receive the following severance benefits following his employment termination: (a) base salary for a period of 6 months; provided that the payment period shall be extended from 6 months to 12 months if such termination occurs within 24 months following a change of control; (b) unless termination is due to his death, that portion of any bonus (on a pro rated basis) that the board of directors, in its discretion, otherwise would have awarded to him as of such date; and (c) reimbursement of Mr. Eldridge or his dependents for the cost of COBRA premiums (less the employee portion thereof) during the 6 or 12 month severance period. In addition, in the event that Mr. Eldridge’s employment is terminated for any reason within the two years following a change of control or his employment were terminated by the company without cause within 30 days prior to a change of control, he would become vested in 100% of his then unvested options. We may also adjust the timing and/or amount of any payment or benefit due to Mr. Eldridge to avoid the imposition of an excise tax upon him pursuant to Section 4999 of the Internal Revenue Code.

Pierre Etienne, M.D. Pursuant to an agreement dated May 6, 2007 between us and Dr. Etienne, Dr. Etienne serves as our Chief Development Officer. Under this agreement, Dr. Etienne’s annual base salary is $300,000 per year, subject to annual review and adjustment from time to time at the discretion of the board of directors. Dr. Etienne is eligible to receive an annual performance bonus of up to 25% of his base salary based upon achievement of certain milestones and performance objectives to be mutually agreed upon by the Board of Directors and Dr. Etienne. Dr. Etienne was previously granted options to purchase (i) 2,666 shares of our common stock at $36.00 per share, (ii) 1,333 shares of our common stock at $70.50 per share and (iii) 6,131 shares of our Québec subsidiary’s capital stock at $41.24 per share. As a result of the consummation of our Series C financing in January and February 2007, Dr. Etienne’s percentage ownership of the company was significantly diluted, and on May 8, 2007, the company made a grant of options to Dr. Etienne to purchase 300,000 shares of common stock at an exercise price of $5.00 per share pursuant to the terms and conditions of the company’s 2005 Stock Option Plan. 100,000 of these options were vested upon grant and the remaining options will vest quarterly over four years, commencing on the date of grant, subject to acceleration in certain circumstances as further described below and as follows: (a) 42,000 shares to vest if the company has filed an NDA with the FDA covering oritavancin prior to September 30, 2007, (b) 14,000 shares to vest upon the initiation by the company of a Phase 2 clinical study of oritavancin using a single dose of oritavancin to treat cSSSI (to be measured by the first patient visit and dosing) that commences prior to June 30, 2007; and (c) 14,000 to vest upon the initiation by the company of a Phase 2 clinical trial of oritavancin as indicated for pneumonia (measured by the first patient visit and dosing) that commences prior to September 30, 2007. By accepting this new option grant, Dr. Etienne agreed to tender for cancellation all options previously granted to him by the company or the company’s Québec subsidiary.

Dr. Etienne has entered into a non-competition, non-solicitation and non-disclosure agreement pursuant to which he has agreed not to compete with the company or to solicit customers or employees of the company for a period of 12 months after the termination of his employment. If Dr. Etienne’s employment is terminated without

 

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cause by the company or due to his death or disability, he will receive the following severance benefits following his employment termination: (a) base salary for a period of 12 months; (b) unless termination is due to his death, that portion of any bonus (on a pro rated basis) that the board of directors, in its discretion, otherwise would have awarded to him as of such date; and (c) reimbursement of Dr. Etienne or his dependents for the cost of COBRA premiums (less the employee portion thereof) during the 12 month severance period. In addition, in the event that Dr. Etienne’s employment is terminated for any reason within the two years following a change of control or if his employment is terminated by the company without cause within 30 days prior to a change of control, he would become vested in 100% of his then unvested options. We may also adjust the timing and/or amount of any payment or benefit due to Dr. Etienne to avoid the imposition of an excise tax upon him pursuant to Section 4999 of the Internal Revenue Code.

Thomas Parr, Ph.D.  Pursuant to an agreement dated May 9, 2007 between us and Dr. Parr, Dr. Parr serves as our Chief Scientific Officer. Under this agreement, Dr. Parr’s annual base salary is $250,000 per year, subject to annual review and adjustment from time to time at the discretion of the board of directors and shall automatically be increased to $275,000 upon consummation of this offering. Dr. Parr is eligible to receive an annual performance bonus of up to 25% of his base salary based upon achievement of certain milestones and performance objectives to be mutually agreed upon by the Board of Directors and Dr. Parr. Dr. Parr was previously granted (a) an option to purchase 1,666 shares of the company’s common stock on March 29, 2006 at $36.00 per share and (b) an option to purchase 1,532 shares of the capital stock of our Québec subsidiary at an exercise price of $46.46. As a result of the consummation of our Series C financing in January and February 2007, Dr. Parr’s percentage ownership of the company was significantly diluted, and on May 8, 2007, the company made a grant of options to Dr. Parr to purchase 150,000 shares of common stock at an exercise price of $5.00 per share pursuant to the terms and conditions of the company’s 2005 Stock Option Plan, of which 37,500 will be vested upon grant and the remaining shares will vest quarterly over three years, subject to acceleration in certain circumstances as described below. By accepting this new option grant, Dr. Parr agreed to tender for cancellation all options previously granted to him by the company or the company’s Québec subsidiary.

Dr. Parr has entered into a non-competition, non-solicitation and non-disclosure agreement pursuant to which he has agreed not to compete with the company or to solicit customers or employees of the company for a period of 12 months after the termination of his employment. If Dr. Parr’s employment is terminated without cause by the company or due to his death or disability or he terminates his employment for good reason within 24 months following a change of control, he will receive the following severance benefits following his employment termination: (a) base salary for a period of 6 months; provided that the payment period shall be extended from 6 months to 12 months if such termination occurs within 24 months following a change of control; (b) unless termination is due to his death, that portion of any bonus (on a pro rated basis) that the board of directors, in its discretion, otherwise would have awarded to him as of such date; and (c) reimbursement of Dr. Parr or his dependents for the cost of COBRA premiums (less the employee portion thereof) during the 6 or 12 month severance period. In addition, in the event that Dr. Parr’s employment is terminated for any reason following a change of control or his employment is terminated by the company without cause within 30 days prior to the consummation of a change of control, he would become vested in 100% of his then unvested options. We may also adjust the timing and/or amount of any payment or benefit due to Dr. Parr to avoid the imposition of an excise tax upon him pursuant to Section 4999 of the Internal Revenue Code.

Christian Bélisle. Pursuant to a letter agreement dated July 10, 2002 between our Québec subsidiary and Mr. Bélisle, Mr. Bélisle serves as our Vice President, Finance and Secretary. Under this agreement, Mr. Bélisle’s annual base salary is $149,573 per year, subject to annual review and adjustment from time to time at the discretion of the board of directors. Mr. Bélisle is eligible to receive an annual performance bonus of up to 20% of his base salary based upon achievement of certain milestones and performance objectives to be mutually agreed upon by the Board of Directors and Mr. Bélisle. In connection with Mr. Bélisle’s commencement of employment, we made an initial grant of options to purchase 833 shares of capital stock of our Québec subsidiary at an exercise price of $36.83 per share, which option vests as follows: (a) 166 shares on the six month anniversary of commencement of employment, (b) 166 shares on the earlier of (i) the 24 month anniversary of

 

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the commencement of employment and (ii) the occurrence of an IPO or sale of the company, (c) 166 shares upon the closing of a sale of the company or a financing in the amount of $12,800,000 or more and (d) 335 shares upon the closing of a sale of the company or an IPO. As a result of the consummation of our Series C financing in January 2007, Mr. Bélisle’s percentage ownership of the company was significantly diluted, and on May 8, 2007, the company made a grant of options to Mr. Bélisle to purchase 20,000 shares of common stock at an exercise price of $5.00 per share pursuant to the terms and conditions of the company’s 2005 Stock Option Plan, of which 5,000 shares will be vested upon grant and the remaining shares will vest quarterly over three years, subject to acceleration in certain circumstances. By accepting this new option grant, Mr. Bélisle agreed to tender for cancellation all options previously granted to him by the company or the company’s Québec subsidiary.

As a condition of employment, Mr. Bélisle has entered into a non-competition, non-solicitation and non-disclosure agreement pursuant to which he has agreed not to compete with the company or to solicit customers or employees of the company for a period of 12 months after the termination of his employment. If Mr. Bélisle’s employment is terminated for any reason other than cause, he will receive the following severance benefits following his employment termination: (a) base salary for a period of 3 months; provided that the payment period shall be extended from 3 months to 6 months if such termination occurs following a change of control or a change in the current Chief Executive Officer of the company; (b) that portion of any bonus (on a pro rated basis) that the board of directors, in its discretion, otherwise would have awarded to him as of such date; and (c) reimbursement of Mr. Bélisle or his dependents for the cost of benefits during the 3 or 6 month severance period.

For a description and quantification of benefits payable to the executive officers named in our Summary Compensation Table in connection with a termination of employment or a change of control, see “— Potential Payments upon Termination or Change of Control.”

Fiscal Year 2006 Equity Awards

All of the stock option awards disclosed in the Grants of Plan-Based Awards table were issued under our 2005 Stock Plan and were granted with an exercise price per share at least equal to the fair market value of our common stock on the date of grant, as determined by our board of directors. Subject to the terms of the 2005 Stock Plan and the option agreements issued in connection with these grants, all of these options granted in 2006 vest as to 25% of the shares on the first anniversary of the grant date and monthly over the following three years. Additionally the vesting conditions for Messrs. Leuchtenberger’s and Eldridge’s, and Drs. Etienne’s and Parr’s stock option grants include an alternate vesting schedule following a change of control (see “Compensation Discussion and Analysis—Termination Based Compensation—Acceleration of vesting of equity based awards.”)

 

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Outstanding Equity Awards at Fiscal Year-End

The following table shows grants of stock options outstanding on December 31, 2006, the last day of our fiscal year, to each of the executive officers named in the Summary compensation table.

 

Name

   Option Awards    Option Exercise
Price ($)(2)
   Option
Expiration
Date
 
   Number of Securities
Underlying
Unexercised Options
(#) Exercisable(1)
   Number of Securities
Underlying Unexercised
Options (#)
Unexercisable(1)
     

Mark Leuchtenberger

   667    9,999    $ 70.50    10/17/16 (3)

Pierre Etienne

   —      2,666    $ 36.00    3/29/16 (4)
   —      1,333    $ 70.50    10/10/16 (5)
   1,532    —      $ 41.24    7/10/13 (6)
   3,942    657    $ 41.24    7/10/13 (7)

George Eldridge

   198    2,968    $ 70.50    10/17/16 (8)

Christian Bélisle

   —      333    $ 36.00    3/29/16 (4)
   498    335    $ 36.83    3/13/13 (9)

Thomas Parr

   —      1,666    $ 36.00    3/29/16 (4)
   333    1,199    $ 46.46    1/19/15 (10)

(1)   All share numbers reflect the 1:150 reverse stock split effected on January 31, 2007.
(2)   All exercise prices reflect the 1:150 reverse stock split effected on January 31, 2007.
(3)   Option granted under the company’s 2005 Stock Option Plan, which option vests as follows: quarterly over four years, beginning December 18, 2006.
(4)   Options granted under the company’s 2005 Stock Option Plan, which option vests as follows: 25% vest on March 29, 2007, with the remainder vesting in 36 equal monthly installments thereafter.
(5)   Option granted under the company’s 2005 Stock Option Plan, which option vests as follows: quarterly over four years, beginning February 13, 2007.
(6)   Option granted under the stock option plan of the company’s Québec located subsidiary, which option vests as follows: in its entirety on December 23, 2003.
(7)   Option granted under the stock option plan of the Company’s Québec located subsidiary, which option vests as follows: quarterly over forty-two months.
(8)   Option granted under the company’s 2005 Stock Option Plan, which option vests as follows: quarterly over four years, beginning December 25, 2006.
(9)   Option granted under the stock option plan of the company’s Québec located subsidiary, which option vests as follows: (a) 166 shares on the six month anniversary of commencement of employment, (b) 166 shares on the earlier of (i) the 24 month anniversary of the commencement of employment and (ii) the occurrence of an IPO or sale of the company, (c) 166 shares upon the closing of a sale of the company or a financing in the amount of CAN$15 million or more and (d) 335 shares upon the closing of a sale of the company or an IPO.
(10)   Option granted under the stock option plan of the company’s Québec located subsidiary, which option vests as follows: annually over four years, beginning January 17, 2006.

 

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In connection with replacement option grants made in May 2007, all of the foregoing options were tendered for cancellation. See “—May 2007 Equity Grants” below.

Outstanding Equity Awards following May 8, 2007 Option Grant and Cancellation of Existing Options

The following table shows grants of stock options outstanding as of May 8, 2007, the date of the grant of both replacement and new stock options to each of the executive officers named in the summary compensation table above. As further discussed under the header “—May 2007 Equity Grants” below, in order to receive these option grants, recipients were required to agree to the cancellation of all outstanding stock options previously granted to them by either the Company or either of its subsidiaries.

Name

   Option Awards    Option Exercise
Price ($)
   Option
Expiration
Date
 
   Number of Securities
Underlying
Unexercised Options
(#) Exercisable
   Number of Securities
Underlying Unexercised
Options (#)
Unexercisable
     

Mark Leuchtenberger

   67,250    470,750    $ 5.00    5/8/17 (1)

Pierre Etienne

   100,000    200,000    $ 5.00    5/8/17 (2)

George Eldridge

   14,375    100,625    $ 5.00    5/8/17 (3)

Christian Bélisle

   5,000    15,000    $ 5.00    5/8/17 (4)

Thomas Parr

   37,500    112,500    $ 5.00    5/8/17 (4)

(1)   Option granted under the company’s 2005 Stock Option Plan, which option vests as follows: quarterly in arrears over four years, beginning September 18, 2006.
(2)   Option granted under the company’s 2005 Stock Option Plan, which option vests as follows: 100,000 of the 300,000 shares vested immediately upon grant; 130,000 of the remaining shares to vest quarterly in arrears over four years; and the remaining 70,000 shares to vest quarterly in arrears over four years, such vesting to be accelerated as follows:

 

   

42,000 shares to accelerate and vest upon the filing of an NDA prior to September 30, 2007;

 

   

14,000 shares to accelerate and vest if the first patient in a single or infrequent dose Phase 2 trial in cSSSI is enrolled prior to June 30, 2007; and

 

   

14,000 shares to accelerate and vest if the first patient in a Phase 2 trial in pneumonia is enrolled prior to September 30, 2007.

 

(3)   Option granted under the company’s 2005 Stock Option Plan, which option vests as follows: quarterly in arrears over four years, beginning September 25, 2006.
(4)   Option granted under the company’s 2005 Stock Option Plan, which option vests as follows: quarterly in arrears over four years, beginning April 1, 2006.

Option Exercises and Stock Vested

We did not have any option exercises by the named executive officers during the fiscal year.

Pension Benefits

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

Nonqualified Defined Contribution Plan

We do not have any nonqualified defined contribution plans.

 

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Potential Payments upon Termination or Change of Control

We have entered into certain agreements and maintain certain plans that may require us to make certain payments and/or provide certain benefits to the executive officers named in the Summary compensation table in the event of a termination of employment or a change of control. See “—Employment agreements” above for a description of the severance and change in control arrangements for Messrs. Leuchtenberger, Eldridge and Bélisle and Drs. Etienne and Parr. Messrs. Leuchtenberger and Eldridge and Drs. Etienne and Parr will only be eligible to receive severance payments if each such officer signs a general release of claims. The tables below summarize the potential payments to each named executive officer assuming that one of the following events occurs. The tables assume that the event occurred on December 31, 2006, the last day of our fiscal year, except that the information related to stock options in the tables below gives effect to the May 2007 stock option grants. We have assumed a price per share of our common stock of $            , which represents the mid-point of the range set forth on the cover of this prospectus.

Under the employment agreements for Messrs. Leuchtenberger and Eldridge and Drs. Etienne and Parr, a change of control is defined to mean any of the following events: (i) the dissolution or liquidation of the company, (ii) any merger or consolidation of the company with one (1) or more corporations where the company is the surviving corporation and the stockholders of the company (including any holder of exchangeable shares of the Canadian subsidiaries) immediately prior to such transaction do not own at least fifty percent (50%) of the company’s outstanding capital stock (assuming the exchange of all outstanding exchangeable shares of the Canadian subsidiaries) immediately after such transaction, (iii) any merger or consolidation of the company with one or more corporations where the company is not the surviving corporation, or (iv) a sale of substantially all of the assets of the company or fifty percent (50%) or more of the then outstanding shares of capital stock of the company (assuming the exchange of all exchangeable shares of the Canadian subsidiaries) to another corporation or entity.

Under the employment agreements for Messrs. Leuchtenberger and Eldridge and Drs. Etienne and Parr, cause is defined to mean (i) employee’s incompetence or failure or refusal to perform satisfactorily any duties reasonably required of employee by the board of directors and/or the company (other than by reason of disability), including employee’s continuing inattention to or neglect of his duties and responsibilities reasonably assigned to him by the company and/or our board of directors; (ii) employee’s violation of any law, rule or regulation (other than traffic violations, misdemeanors or similar offenses) or cease-and-desist order, court order, judgment, regulatory directive or agreement or employee’s conviction of or plea of nolo contendere to a felony or a crime involving moral turpitude; (iii) the commission or omission of or engaging in any act or practice that constitutes a material breach of employee’s fiduciary duty to the company, involves personal dishonesty, fraud or misrepresentation on the part of employee or demonstrates a willful or continuing disregard for the best interests of the company; (iv) employee’s engaging in dishonorable or disruptive behavior, practices or acts that would be reasonably expected to harm or bring disrepute to the company, its subsidiaries, its business or any of its customers, employees or vendors; or (v) a breach by employee of his obligations under the non-competition, non-solicitation, non-disclosure and ownership of inventions agreement or any company code of conduct or ethics or other company policies or practices.

Under the employment agreements for Messrs. Leuchtenberger and Eldridge and Dr. Parr, good reason is defined to mean: (i) the failure of the company to employ employee in his current or a substantially similar position, without regard to title, such that his duties and responsibilities are materially diminished without his consent (provided that he notifies the company in writing of such diminution of duties within 60 days of the diminution); (ii) a reduction in employee’s base salary and/or target annual bonus without his consent (unless such reduction is in connection with a proportional reduction in compensation to all or substantially all of the company’s employees); or (iii) a permanent relocation of employee’s primary place of employment more than 50 miles from his current site of employment without employee’s consent.

Under the letter agreement for Mr. Bélisle, change of control and cause are not defined.

 

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Mark Leuchtenberger, President and Chief Executive Officer

 

     Termination not
for cause
    Involuntary
termination or
resignation for
good reason in
connection with
or following a
change of control
    Death     Disability  

Base Salary

   $ 350,000 (1)   $ 350,000 (1)   $ 350,000 (1)   $ 350,000 (1)

Bonus

   $ 175,000 (2)   $ 175,000 (2)     —       $ 175,000 (2)

Benefits

   $ 23,981 (3)   $ 23,981 (3)   $ 23,981 (3)   $ 23,981 (3)

Number of Stock Options

     —         538,000 (4)     —         —    

Value

     —                      (5)     —         —    

Total

   $ 548,981     $                          $ 373,981     $ 548,981  

(1)   Continuation of base salary for 12 months following termination of employment by the Company without cause, due to death or disability or on account of resignation for good reason within 24 months following a change of control. If termination occurs after Mr. Leuchtenberger has been employed for at least 24 months (September 2008), the payment period shall be extended from 12 to 18 months, resulting in aggregate payments of salary continuation of $525,000.
(2)   Represents the maximum bonus of 50% of base salary; pursuant to his employment agreement, Mr. Leuchtenberger would be eligible to receive that portion of any bonus (on a pro rated basis) that the board of directors, in its discretion, otherwise would have awarded to him as of his termination date.
(3)   Represents the cost of COBRA premiums (less employee portion of premiums) for 12 months following termination. If termination occurs after Mr. Leuchtenberger has been employed for at least 24 months (September 2008), the payment period shall be extended from 12 to 18 months, resulting in aggregate cost of $35,977.
(4)   Includes options granted to Mr. Leuchtenberger in May 2007 that replace all options previously granted to Mr. Leuchtenberger. All of Mr. Leuchtenberger’s stock options would become fully vested if his employment terminates for any reason within two years following a change of control.
(5)   Value upon termination is calculated using a value for our common stock of $             per share, the midpoint of the range set forth on the cover of this prospectus.

George Eldridge, Senior Vice President, Finance & Administration, Treasurer

 

     Termination not
for cause
    Involuntary
termination or
resignation for
good reason in
connection with
or following a
change of control
    Death     Disability  

Base Salary

   $ 137,500 (1)   $ 275,000 (1)   $ 137,500 (1)   $ 137,500 (1)

Bonus

   $ 68,750 (2)   $ 68,750 (2)     —       $ 68,750 (2)

Benefits

   $ 10,104 (3)   $ 20,208 (3)   $ 10,104 (3)   $ 10,104 (3)

Number of Stock Options

     —         115,000 (4)     —         —    

Value

     —                      (5)     —         —    

Total

   $ 216,354     $                      $ 147,604     $ 216,354  

(1)   Continuation of base salary for 6 months following termination. If termination occurs within 24 months following a change of control, continuation of base salary will be extended from 6 months to 12 months.
(2)   Represents the maximum bonus of 25% of base salary; pursuant to his employment agreement, Mr. Eldridge would be eligible to receive that portion of any bonus (on a pro rated basis) that the board of directors would have awarded to him as of his termination date.

 

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(3)   Represents the cost of COBRA premiums (less employee portion of premiums) for 6 months following termination. If termination occurs within 24 months following change of control, such payment period shall be extended from 6 to 12 months, resulting in aggregate cost of $20,208.
(4)   Includes options granted to Mr. Eldridge in May 2007 that replace all options previously granted to Mr. Eldridge. All of Mr. Eldridge’s stock options would become fully vested if the company terminates his employment without cause within 30 days prior to a change of control or if his employment terminates for any reason within two years following a change of control.
(5)   Value upon termination is calculated using a value for our common stock of $            per share, the midpoint of the range set forth on the cover of this prospectus.

Pierre Etienne, Chief Development Officer

 

     Termination not
for cause
    Involuntary
termination in
connection with
or following a
change of control
    Death     Disability  

Base Salary

   $ 300,000 (1)   $ 300,000 (1)   $ 300,000 (1)   $ 300,000 (1)

Bonus

   $ 75,000 (2)   $ 75,000 (2)     —       $ 75,000 (2)

Benefits

   $ 3,210 (3)   $ 3,210 (3)   $ 3,210 (3)   $ 3,210 (3)

Number of Stock Options

     —         300,000 (4)     —         —    

Value

     —                      (5)     —         —    

Total

   $ 378,210     $                      $ 303,210     $ 378,210  

(1)   Continuation of base salary for 12 months following termination.
(2)   Represents the maximum bonus of 25% of base salary; pursuant to his employment agreement, Dr. Etienne would be eligible to receive that portion of any bonus (on a pro rated basis) that the board of directors would have awarded to him as of the termination date.
(3)   Represents the cost of COBRA premiums (less employee portion of premiums for 12 months following termination).
(4)   Includes options granted to Dr. Etienne in May 2007 that replace all options previously granted to Dr. Etienne. All of Dr. Etienne’s stock options would become fully vested if the company terminates his employment without cause within 30 days prior to a change of control or if his employment terminates for any reason within the two years following a change of control.
(5)   Value upon termination is calculated using a value for our common stock of $            per share, the midpoint of the range set forth on the cover of this prospectus.

Thomas Parr, Chief Scientific Officer

 

     Termination not
for cause
    Involuntary
termination or
resignation for
good reason in
connection with
or following a
change of control
    Death     Disability  

Base Salary

   $ 137,500 (1)   $ 275,000 (1)   $ 137,500 (1)   $ 137,500 (1)

Bonus

   $ 68,750 (2)   $ 68,750 (2)     —       $ 68,750 (2)

Benefits

   $ 5,650 (3)   $ 11,300 (3)   $ 5,650 (3)   $ 5,650 (3)

Number of Stock Options

     —         150,000 (4)     —         —    

Value

     —                      (5)     —         —    

Total

   $ 211,900     $                      $ 143,150     $ 211,900  

(1)   Continuation of base salary for 6 months following termination.
(2)   Represents the maximum bonus of 25% of base salary; pursuant to his employment agreement, Dr. Parr would be eligible to receive that portion of any bonus (on a pro rated basis) that the board of directors would have awarded to him as of his termination date.

 

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(3)   Represents the cost of COBRA premiums (less employee portion of premiums) for 6 months following termination. If termination occurs within 24 months following change of control, such payment period shall be extended from 6 to 12 months, resulting in aggregate cost of $11,300.
(4)   Includes options granted to Dr. Parr in May 2007 that replace all options previously granted to Dr. Parr. All of Dr. Parr’s stock options would become fully vested if the company terminates his employment without cause within 30 days prior to a change of control or if his employment terminates for any reason within the two years following a change of control.
(5)   Value upon termination is calculated using a value for our common stock of $             per share, the midpoint of the range set forth on the cover of this prospectus.

Christian Bélisle, Vice President, Finance and Secretary

     Termination not
for cause
   

Involuntary

termination in

connection with

or following a

change of control or

a change in CEO

    Death     Disability  

Base Salary

   $ 37,393 (1)   $ 74,786 (1)   $ 37,393 (1)   $ 37,393 (1)

Bonus

   $ 29,915 (2)   $ 29,915 (2)   $ 29,915 (2)   $ 29,915 (2)

Benefits

   $ 2,121 (3)   $ 4,242 (3)   $ 2,121 (3)   $ 2,121 (3)

Number of Stock Options

     —         20,000 (4)     —         —    

Value

     —            (5)     —         —    

Total

   $ 69,429     $       $ 69,429     $ 69,429  

(1)   Continuation of base salary for 3 months following termination. If termination occurs following a change of control or a change in the current CEO, continuation of base salary will be extended from 3 to 6 months.
(2)   Represents the maximum bonus of 20% of base salary; pursuant to his employment agreement, Mr. Bélisle would be eligible to receive that portion of any bonus (on a pro rated basis) that the board of directors would have awarded to him as of his termination date.
(3)   Represents reimbursement of Mr. Bélisle’s cost of health, dental, life and disability insurance premiums, as well as the payment of professional accountant fees for the 3 months following termination. If termination occurs following a change of control or a change in the current CEO, such termination period shall be extended from 3 to 6 months.
(4)   Includes options granted to Mr. Bélisle in May 2007 that replaced all options previously granted to Mr. Bélisle. All of Mr. Bélisle’s stock options would become fully vested if our Québec located subsidiary terminates his employment without cause following a change of control.
(5)   Value upon termination is calculated using a value for our common stock of $             per share, the midpoint of the range set forth on the cover page of this prospectus.

Director Compensation

As a privately held company, we have not historically provided cash compensation to our directors for their services as members of the board of directors or for attendance at board of directors or committee meetings. However, our directors are reimbursed for reasonable travel and other expenses incurred in connection with attending meetings of the Board and its committees. Under our 2005 Stock Plan, directors are eligible to receive stock option grants at the discretion of the compensation committee.

 

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The following table sets forth a summary of the compensation earned by our directors and/or paid to certain of our directors pursuant to certain agreements we have with them in 2006, other than Mr. Leuchtenberger. Amounts included under Options awards below represent the fair value of the award calculated under SFAS 123(R).

 

Name

  

Fees Earned or

Paid in Cash ($)(1)

   Option Awards ($)(2)     All Other
Compensation ($)
   Total ($)

William Crouse

   $ 10,000    $ 767 (3)(6)   —      $ 10,767

Dilip Mehta

   $ 10,000    $ 2,003 (4)(6)   —      $ 12,003

Robin Steele

     —      $ 48 (5)(6)   —      $ 48

Jeff Courtney

     —        —       —        —  

Eric Gordon

     —        —       —        —  

Jay Venkatesan

     —        —       —        —  

(1)   Represents cash retainer director fees.
(2)   This column shows the amounts recognized in 2006 for financial statement reporting purposes under SFAS 123(R), without regard to any estimate of forfeitures related to service-based vesting conditions. The exercise price of each of these grants was well in excess of the fair value of our common stock on the date of grant, and as a result, the SFAS 123(R) value was determined to be $1.50. See Note 14 to our Consolidated Financial Statements, “Stock Option Plans,” included below in this prospectus, for a discussion of the assumptions used in calculating the SFAS 123(R) expense. During 2006, options to purchase 617 shares of our common stock were either forfeited or expired, none of which included options to purchase shares of our common stock that were held by executive officers and directors.
(3)   Nonqualified stock options granted on March 29, 2006, exercisable (on a post-split basis) for 1,067 shares of the company’s common stock at an exercise price (on a post-split basis) of $36.00 per share, with 25% of such shares vested upon grant and the remaining shares vesting annually over the remaining three years.
(4)   Nonqualified stock options granted on March 29, 2006, exercisable (on a post-split basis) for 333 shares of the company’s common stock at an exercise price (on a post-split basis) of $36.00 per share, with 25% of such shares vested upon grant and the remaining shares vesting annually over the remaining three years.
(5)   Nonqualified stock options granted on March 29, 2006, exercisable (on a post-split basis) for 66 shares of the company’s common stock at an exercise price (on a post-split basis) of $36.00 per share, with 25% of such shares vested upon grant and the remaining shares vesting annually over the remaining three years.
(6)   In addition to the options shown in this table, on May 8, 2007, our compensation committee granted non-qualified stock options to Mr. Crouse (exercisable for up to 50,000 shares of our common stock), Dr. Mehta (exercisable for up to 29,200 shares of our common stock) and Ms. Steele (exercisable for up to 6,000 shares of our common stock), all of which options were granted at an exercise price of $5.00 per share. Fifty percent of the options granted to each of Mr. Crouse and Dr. Mehta were vested upon grant, with the remaining shares to vest quarterly over two years. The options granted to Ms. Steele were fully vested upon grant.

Director Compensation Policy

In May 2007, our board of directors adopted a compensation program for non-employee directors. This compensation program will be effective immediately upon the closing of our initial public offering. Pursuant to this program, each member of our board of directors who is not an employee will receive the following cash compensation for board services, as applicable:

 

   

$30,000 per year for service as a board member;

 

   

$12,000 per year for service as chairman of the audit committee;

 

   

$7,500 per year for service as chairman of the compensation committee;

 

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$5,000 per year for service as chairman of the nominating and corporate governance committee;

 

   

$500 for each audit committee meeting attended ($1,000 for the chairman of the audit committee for each meeting attended);

 

   

$500 for each compensation committee meeting attended; and

 

   

$500 for each nominating and corporate governance committee meeting attended.

We will also reimburse our non-employee directors for their reasonable expenses incurred in attending meetings of our board of directors and committees of the board of directors.

Additionally, members of our board of directors who are not our employees will receive non-statutory stock options under our 2007 Equity Incentive Plan, which will become effective as of the effective date of our initial public offering. Each non-employee director joining our board of directors after the closing of our initial public offering will automatically be granted a non-statutory stock option to purchase 25,000 shares of common stock with an exercise price equal to the then fair market value of our common stock. On the date of each annual meeting of our stockholders beginning in 2008, each non-employee director will also automatically be granted a non-statutory stock option to purchase 10,000 shares of our common stock with an exercise price equal to the then fair market value of our common stock. Initial grants will vest ratably in four equal installments on the date of grant and each of the first three anniversaries of the grant date. Automatic annual grants will vest in full upon grant. All stock options granted under our 2007 Equity Incentive Plan to non-employee directors will have a term of up to ten years.

Upon the effectiveness of this offering, we will be making an initial option grant to purchase 25,000 shares to each of Mr. Gordon, Mr. Courtney and Mr. Venkatesan which option grant will be at an exercise price equal to the price of our common stock in connection with the offering.

2005 Stock Option Plan

Our 2005 stock option plan, or the 2005 Option Plan, was adopted by our board of directors and approved by our stockholders in December 2005 and our board of directors and stockholders approved amendments to our 2005 Option Plan in August 2006, January 2007 and March 2007. Under this plan, we may grant incentive stock options and nonqualified stock options to employees, officers, directors, consultants and advisors of the company. A maximum of 2,051,749 shares of common stock are currently authorized for issuance under our 2005 Option Plan. Further, options forfeited under the option plan of our Québec located subsidiary—up to a maximum number of 13,561—will also become available for grant under our 2005 Stock Option Plan.

Our 2005 Option Plan is administered by our board of directors, which may delegate its administration authority to the compensation committee. The compensation committee selects the participants, establishes the price, terms and conditions of each option, including the vesting provisions, issues shares upon option exercises and interprets option agreements. The board of directors may at any time modify or amend the 2005 Option Plan in any respect, except where stockholders’ approval is required by law or where such termination or modification or amendment affects the rights of an optionee under a previously granted option and such optionee’s consent has not been obtained.

Under our 2005 Option Plan, the exercise price of all options must not be less than 100% of the fair market value of our common stock on the date of such grant or, in the case of a grant to a 10% stockholder, not less than 110% of the fair market value of our common stock on the date of such grant. Additionally, the term of any option granted under the 2005 Option Plan may not exceed 10 years from the date of grant.

In the event of a change of control, the compensation committee may provide for (a) the continuation or assumption of such outstanding options by the company or by the surviving corporation or its parent, (b) the substitution by the surviving corporation or its parent of options with substantially the same terms for such

 

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outstanding options, (c) the acceleration of the vesting of such options immediately prior to or as of the date of the transaction, and the expiration of such outstanding options to the extent not timely exercised by the date of the transaction or (d) the cancellation of all or any portion of such outstanding options by a cash payment of the excess, if any, of the fair market value of the shares subject to such outstanding options or portions thereof being canceled over the option price.

Immediately upon termination of employment of an employee, the unvested portion of any stock option will terminate and the balance, to the extent exercisable, will remain exercisable for the lesser of (i) a period of three months or (ii) the period ending on the latest date on which such stock option could have been exercised without regard to this provision. The plan provides exceptions for the vesting of options upon an individual’s death, disability or termination for cause.

We do not intend to grant additional options under our 2005 Option Plan after this offering and the aggregate number of shares to be issued under our 2005 Option Plan will be reduced to             , which represents the total number of shares issuable upon the exercise of options that are outstanding prior to the completion of this offering.

May 2007 Equity Grants

On May 8, 2007, our compensation committee granted options to our officers, employees and certain non-employee board members to purchase a total of 1,771,850 shares of our common stock at an exercise price of $5.00 per share. In addition, on May 15, 2007, our board of directors granted a stock option exercisable for 25,000 shares of our common stock at an exercise price of $5.00 per share to a new, non-employee director. Upon completion of this offering, these grants will represent         % of total shares outstanding (assuming the exchange, conversion and exercise of all exchangeable, convertible and exercisable securities). All of these options were granted pursuant to the terms and conditions of our 2005 Stock Option Plan. These options generally vest quarterly over four years, subject to acceleration of all unvested options if the employment of the option holder is terminated within two years following a change of control. In the case of certain long-time employees, both new and replacement options vest quarterly over four additional years with an initial vesting date of April 1, 2006. In connection with this grant, a total of 42,135 options to purchase shares of our common stock with exercise prices that ranged from $36.00 to $70.50 will be cancelled upon acceptance of these replacement option grants.

2007 Equity Incentive Plan

Our 2007 Equity Incentive Plan, or 2007 Plan, was adopted by our board of directors and approved by our stockholders in             , 2007 and will become effective upon the effectiveness of this registration statement. The 2007 Plan permits us to make grants of incentive stock options, non-qualified stock options, stock appreciation rights, deferred stock awards, restricted stock awards, unrestricted stock awards, and dividend equivalent rights. We reserved             shares of our common stock for the issuance of awards under the 2007 Plan. This number is subject to adjustment in the event of a stock split, stock dividend or other change in our capitalization. In addition, the number of shares available for future grant will automatically increase each year by an amount equal to 3.5% of all shares of our capital stock outstanding on January 1 st of each year unless our board of directors takes action in any given year to set this increase at a lesser amount. Generally, shares that are forfeited or canceled from awards under the 2007 Plan also will be available for future awards. In addition, awards that are returned to our 2005 Option Plan as a result of their expiration, cancellation, termination or repurchase are automatically made available for issuance under our 2007 Plan. No awards have been granted under the 2007 Plan.

The 2007 Plan is administered by our compensation committee, or another committee of at least two independent, non-employee directors. The administrator of the 2007 Plan has full power and authority to select the participants to whom awards will be granted, to grant any combination of awards to participants, to accelerate the exercisability or vesting of any award and to determine the specific terms and conditions of each award, subject to the provisions of the 2007 Plan.

 

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All full-time and part-time officers and other employees, non-employee directors and other key persons (including consultants and prospective employees) are eligible to participate in the 2007 Plan, subject to the discretion of the administrator. There are certain limits on the number of awards that may be granted under the 2007 Plan. For example, no more than             shares of stock may be granted in the form of stock options or stock appreciation rights to any one individual during any one-calendar-year period under the 2007 Plan.

The exercise price of stock options awarded under the 2007 Plan may not be less than the fair market value of the common stock on the date of the option grant and the term of each option may not exceed 10 years from the date of grant. The administrator will determine at what time or times each option may be exercised and, subject to the provisions of the 2007 Plan, the period of time, if any, after retirement, death, disability or other termination of employment during which options may be exercised.

To qualify as incentive options, stock options must meet additional federal tax requirements, including a $100,000 limit on the value of shares subject to incentive options that first become exercisable in any one calendar year, and a shorter term and higher minimum exercise price in the case of a certain large stockholder. No incentive stock option awards may be granted under the 2007 Plan after             , 2017.

We may also grant stock appreciation rights under our 2007 Plan. Stock appreciation rights allow the recipient to receive the appreciation in the fair market value of our common stock between the exercise date and the date of grant. The administrator of the 2007 Plan determines the terms of stock appreciation rights, including when these rights become exercisable and whether to pay the increased appreciation in cash or with shares of our common stock, or a combination thereof. The exercise price of stock appreciation rights granted under our 2007 Plan may not be less than the fair market value of our common stock on the date of grant.

We may also grant restricted stock awards under our 2007 Plan. Restricted stock awards are shares of our commons stock that vest in accordance with terms and conditions established by the administrator. The administrator of our 2007 Option Plan will determine the number of shares of restricted stock granted to any recipient. The administrator may impose whatever vesting conditions it determines to be appropriate. For example, the administrator may set restrictions based on the achievement of specific performance goals. Shares of restricted stock that do not vest are subject to our right of repurchase or forfeiture.

We may also grant deferred stock awards under our 2007 Plan. Deferred stock awards are units entitling the recipient to receive shares of stock paid out on a deferred basis, and subject to such restrictions and conditions, as the administrator shall determine. Certain grantees, including directors, will be permitted to defer their compensation and receive deferred stock awards in lieu of current cash compensation. All deferred compensation will be structured to meet the requirements of Section 409A of the Internal Revenue Code. Our 2007 Plan also gives the administrator discretion to grant stock awards free of any restrictions.

We may also grant dividend equivalent rights under our 2007 Plan. Dividend equivalent rights are awarded entitling the grantee to current or deferred payments equal to dividends on a specified number of shares of stock. Dividend equivalent rights may be settled in cash or shares and subject to other conditions, as the administrator of our 2007 Plan shall determine.

The 2007 Plan provides for the acceleration of all unvested options or equity awards if the employment of the option holder is terminated for certain reasons following a change of control.

Our board of directors may amend or discontinue the 2007 Plan at any time and the administrator of our 2007 Plan may amend or cancel any outstanding award for the purpose of satisfying changes in law or for any other lawful purpose. No such amendment may adversely affect the rights under any outstanding award without the holder’s consent. Other than in the event of a necessary adjustment in connection with a change in our stock or a change of control, the administrator may not “reprice” or otherwise reduce the exercise price of outstanding stock options. Further, amendments to the 2007 Plan will be subject to approval by our stockholders if the

 

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amendment (1) increases the number of shares available for issuance under the 2007 Plan above and beyond the 3.5% automatic annual increases discussed above, (2) expands the types of awards available under, the eligibility to participate in, or the duration of, the plan, (3) materially changes the method of determining fair market value for purposes of the 2007 Plan, (4) is required by the Nasdaq Global Market rules or (5) is required by the Internal Revenue Code to ensure that incentive options are tax-qualified.

Limitation of Liability and Indemnification

As permitted by the Delaware General Corporation Law, we have adopted provisions in our certificate of incorporation and by-laws to be in effect at the closing of this offering that limit or eliminate the personal liability of our directors. Consequently, a director will not be personally liable to us or our stockholders for monetary damages for any breach of fiduciary duty as a director, except for liability for:

 

   

any breach of the director’s duty of loyalty to us or our stockholders;

 

   

any act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;

 

   

any unlawful payments related to dividends or unlawful stock repurchases, redemptions or other distributions; or

 

   

any transaction from which the director derived an improper personal benefit.

These limitations of liability do not alter director liability under the federal securities laws and do not affect the availability of equitable remedies such as an injunction or rescission.

In addition, our by-laws provide that:

 

   

we will indemnify our directors, executive officers and, in the discretion of our board of directors, employees to the fullest extent permitted by the Delaware General Corporation Law; and

 

   

we will advance expenses, including attorneys’ fees, to our directors and, in the discretion of our board of directors, to executive officers and employees, in connection with legal proceedings, subject to limited exceptions.

We have entered into indemnification agreements with each of our directors and executive officers. These agreements provide that we will indemnify these directors and executive officers to the fullest extent permitted by law and our certificate of incorporation and by-laws, and advance expenses to each indemnitee in connection with any proceeding in which indemnification is available.

We also intend to obtain, contemporaneously with the offering, a general liability insurance that covers certain liabilities of our directors and officers arising out of claims based on acts or omissions in their capacities as directors or officers, including liabilities under the Securities Act. Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors or officers of the Company, or persons controlling the Company pursuant to the foregoing provisions, we have been informed that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.

These provisions may discourage stockholders from bringing a lawsuit against our directors for breach of their fiduciary duty. These provisions may also have the effect of reducing the likelihood of derivative litigation against directors and officers, even though such an action, if successful, might otherwise benefit us and our stockholders. Furthermore, a stockholder’s investment may be adversely affected to the extent we pay the costs of settlement and damage awards against directors and officers pursuant to these indemnification provisions. We believe that these provisions, the indemnification agreements and the insurance are necessary to attract and retain talented and experienced directors and officers.

At present, there is no pending litigation or proceeding involving any of our directors or officers where indemnification will be required or permitted. We are not aware of any threatened litigation or proceeding that might result in a claim for such indemnification.

 

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CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS

Since May 1, 2004, we, or in the case of the period prior to our inception in December 2005, our Québec subsidiary has engaged in the following transactions with our directors, officers and holders of more than five percent of our voting securities and their affiliates.

Convertible Debt Issuances

October 2005 Convertible Note Financing. On October 28, 2005, our Québec subsidiary issued and sold convertible notes with an aggregate principal amount of CAN$1,747,841 in a private placement to three United States investors and two non-U.S. purchasers, each of whom is an accredited investor under both applicable Canadian and United States definitions. The issuance of these securities met the conditions for the private issuer exemption under National Instrument 45-106 adopted by the Canadian Securities Administrators. Simultaneously, our Québec subsidiary issued to these purchasers warrants to purchase an aggregate of up to 5,600 Class A-2 preferred shares (which shares were, on December 23, 2005, reclassified as Class B preferred exchangeable shares). On December 23, 2005, the three United States investors who participated in this private placement and one of the two non-U.S. investors exchanged the securities they received from our Québec subsidiary for like securities issued by us. Further, on that same date, all of the warrants issued in this transaction (including those reissued by us on December 23, 2005 in exchange for like securities originally issued by our Québec subsidiary in October 2005) were exercised in full and, in a transaction exempt from registration pursuant to Regulation S, we issued shares of our special voting stock to the one remaining non-U.S. purchaser holding securities from this transaction issued by our Québec subsidiary. Each of the convertible notes issued by our Québec subsidiary (including those later exchanged for replacement convertible notes issued by us) accrued interest at an annual rate of 8% and was, as further described below, converted into shares of our capital stock on January 31, 2007. The following table sets forth investments made by investors either holding five percent or more of our Québec subsidiary’s outstanding voting securities or affiliated with a member of our Québec subsidiary’s board of directors at the time of the transaction:

 

Investor

  

Related Party / Relationship

   Warrants to
Purchase Shares
of Series B
Preferred
Stock(1)
  

Amount
Invested(2)

T 2 C 2 /Bio 2000, société en commandite

   5% stockholder    1,309   

CAN$748,261

($635,790)

Canadian Medical Discovery Funds Inc.

   5% stockholder    933   

CAN$291,250

($247,472)

Seaflower Health Ventures III, L.P.

   5% stockholder and affiliated with Alex Moot, Director    2,398   

CAN$408,555

($347,145)

Seaflower Health Ventures Companion Fund, L.P.

   Affiliated with Alex Moot, Director    21   

CAN$6,650

($5,650)

Dilip Mehta

   Director    939   

CAN$293,125

($249,065)


(1)   Shares shown on an as-if exchanged basis.
(2)   Investments were made in Canadian dollars; United States dollar amounts were calculated based on spot interest rate on October 28, 2005, the date on which these securities were issued.

December 2005 Convertible Note Financing . On December 23, 2005, we issued convertible notes with an aggregate principal amount of $3,950,000 to six accredited investors in a private placement under Section 4(2) of the Securities Act. Simultaneously, we issued to these purchasers warrants to purchase an aggregate of up to 19,134 shares of our Series B preferred stock, which warrants were immediately exercised in full. In addition, in connection with this transaction, our two Canadian subsidiaries issued and sold convertible notes to a total of

 

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three non-U.S. purchasers, each of whom is an accredited investor, with an aggregate principal amount of $6,350,000. In addition, in connection with the issuance by our Québec and Ontario subsidiaries of warrants to purchase up to an aggregate of 29,880 Class B preferred exchangeable shares of these subsidiaries to four non-U.S. purchasers, which warrants were immediately exercised in full and we issued a like number of shares of our Series B special voting stock to these four non-U.S. purchasers in a transaction exempt from registration pursuant to Regulation S. Each of these convertible notes accrued interest at an annual rate of 8% and was, as further described below, converted into shares of our capital stock on January 31, 2007. The following table sets forth investments made by investors holding five percent or more of our outstanding voting securities or affiliated with members of our board of directors at the time of this transaction:

 

Investor

  

Related Party / Relationship

   Warrant to
Purchase Shares of
Series B Preferred
Stock(1)
   Amount
Invested

T 2 C 2 /Bio 2000, société en commandite

  

5% stockholder

   9,200    $ 2,300,000

Canadian Medical Discovery Funds Inc.

  

5% stockholder and affiliated with Gerry Brunk, Director

   933    $ 1,700,000

Seaflower Health Ventures III, L.P.

   5% stockholder and affiliated with Alex Moot, Director    4,377    $ 1,094,363

Seaflower Health Ventures Companion Fund, L.P.

  

Affiliated with Alex Moot, Director

   39    $ 5,637

J&L Sherblom Family LLC

   Affiliated (indirectly) with Alex Moot, Director    1,000    $ 250,000

William Crouse

  

Director

   1,000    $ 250,000

Dilip Mehta

  

Director

   200    $ 250,000

(1)   Shares shown on an as-if exchanged basis.

December 2006 Convertible Debenture Financing. On December 7 and 19, 2006, we issued and sold convertible debentures in an aggregate principal amount of $3,450,000 to three accredited investors in a private placement under Section 4(2) of the Securities Act. In addition, in connection with this transaction, our Ontario subsidiary issued and sold convertible debentures to three non-U.S. purchasers, each of whom is an accredited investor, in an aggregate principal amount of $8,378,000. These convertible debentures accrued interest at an annual rate of 8% and were, as further detailed below, converted into shares of our capital stock on January 31, 2007. The following table sets forth investments made by investors holding five percent or more of our outstanding voting securities or affiliated with members of our board of directors at the time of this transaction:

 

Investor

  

Related Party

   Amount
Invested

VenGrowth Advanced Life Sciences Fund Inc.

  

5% stockholder and

affiliated with Jeffrey Courtney, Director

   $ 6,000,000

VenGrowth III Investment Fund Inc.

  

5% stockholder and

affiliated with Jeffrey Courtney, Director

   $ 378,000

Canadian Medical Discovery Funds Inc.

  

5% stockholder and

affiliated with Donna Parr, Director

   $ 3,000,000

T 2 C 2 /Bio 2000, société en commandite

  

5% stockholder

   $ 3,000,000

Seaflower Health Ventures III, L.P.

  

5% stockholder and

affiliated with Alex Moot, Director

   $ 1,000,000

J&L Sherblom Family LLC

  

Affiliated (indirectly) with Alex Moot,

Director

   $ 200,000

Dilip Mehta

  

Director

   $ 50,000

 

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Stock and Warrant Issuances

Series C Financing . On January 31 and February 16, 2007, we issued and sold (on an as-if exchanged basis) 2,361,017 shares of our Series C-1 preferred stock, 1,081,171 shares of our Series C-2 preferred stock and 6,333,974 shares of our Series C-3 preferred stock at a purchase price of $10.45 per share in consideration of (i) gross cash proceeds of approximately $58.1 million, (ii) the conversion of previously issued convertible promissory notes in the aggregate amount of $24.6 million, including principal and accrued interest, and (iii) the conversion of $17.5 million of convertible notes payable to InterMune. This transaction was structured as a private placement to accredited investors exempt from registration pursuant to Section 4(2) of the Securities Act. The following table sets forth the number of shares purchased (on an as-exchanged basis) and the aggregate purchase price paid by investors holding five percent or more of our outstanding voting securities and/or affiliated with one or more members of our board of directors at the time of this transaction:

 

Investor

   Related Party /
Relationship
  

Number and Type of Shares
Purchased

  

Warrant to
Purchase
Shares of

Series C-1
Preferred Stock

   Aggregate
Purchase Price(1)
 
Brookside Capital Partners Fund, L.P.    5%
stockholder
and

affiliated with
Jay Venkatesan
   1,674,390 shares of Series C-3 preferred stock    82,956    $ 17,500,004.30 (2)
VenGrowth Advanced Life Sciences Fund Inc.    5%
stockholder
and
affiliated with
Jeff Courtney,
Director
  

•  452,457 shares of Series C-1 preferred stock

 

•  287,038 shares of Series C-2 preferred stock

 

•  287,038 shares of Series C-3 preferred stock

   50,859    $ 10,728,881.51  
VenGrowth III Investment Fund Inc.    5%
stockholder
and
affiliated with
Jeff Courtney,
Director
  

•  34,206 shares of Series C-1 preferred stock

 

•  18,083 shares of Series C-2 preferred stock

 

•  18,083 shares of Series C-3 preferred stock

   3,487    $ 735,497.89  
InterMune, Inc.    5%
stockholder
and

affiliated with
Robin Steele,
Director
   956,794 shares of Series C-1 preferred stock    47,403    $ 9,999,999.47  
Canadian Medical Discoveries Fund Inc.(3)    5%
stockholder
and

affiliated with
Donna Parr,
Director
  

•  238,384 shares of Series C-1 preferred stock

 

•  143,519 shares of Series C-2 preferred stock

 

•  143,519 shares of Series C-3 preferred stock

   26,032    $ 5,491,484.78  

 

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Investor

   Related Party /
Relationship
  

Number and Type of Shares
Purchased

   Warrant to
Purchase
Shares of
Series C-1
Preferred
Stock
   Aggregate
Purchase Price(1)
 
Seaflower Health Ventures III, L.P.    5%
stockholder
and
affiliated with
Alex Moot,
Director
  

•  249,743 shares of Series C-1 preferred stock

 

•  47,839 shares of Series C-2 preferred stock

 

•  47,839 shares of Series C-3 preferred stock

   17,114    $ 3,610,191.77  
Seaflower Health Ventures Companion Fund, L.P.    Affiliated
with
Alex Moot,
Director
   1,785 shares of Series C-1 preferred stock    89    $ 18,656.06  
Skyline Venture Partners Qualified Purchaser Fund IV, L.P.    5%
stockholder
and
affiliated with
Eric Gordon,
Director
   1,119,449 shares of Series C-3 preferred stock    55,462    $ 11,699,999.59 (2)
Skyline Venture Partners Qualified Purchaser Fund III, L.P.    Affiliated
with
Eric Gordon,
Director
  

326,742 shares of Series

C-3 preferred stock

   16,188    $ 3,414,966.89 (2)
Skyline Venture Partners III, L.P.    Affiliated
with
Eric Gordon,
Director
   8,136 shares of Series C-3 preferred stock    403    $ 85,033.98 (2)
Dilip Mehta    Director   

•  58,305 shares of Series C-1 preferred stock

 

•  11,959 shares of Series C-2 preferred stock

 

•  11,959 shares of Series C-3 preferred stock

   4,074    $ 859,359.45  
William Crouse    Director   

•  26,048 shares of Series C-1 preferred stock

 

•  4,783 shares of Series C-2 preferred stock

 

•  4,783 shares of Series C-3 preferred stock

   1,765    $ 372,222.22 (4)

(1)   Except as otherwise noted, purchase price paid through the conversion of outstanding principal and accrued interest on convertible notes issued in October and December 2005 and/or convertible debentures issued in December 2006.
(2)   New cash investment.
(3)   Also received a warrant exercisable for 4,917 shares of common stock in connection with its common stock holdings.
(4)   Includes a new cash investment of $99,979.72.

 

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All outstanding shares of our Series C-1, Series C-2 and Series C-3 preferred stock will be automatically converted into shares of our common stock upon the consummation of this offering.

Achievement of InterMune Milestone . On February 7, 2007, upon our achievement of the first milestone under the asset purchase agreement, dated December 23, 2005, as amended, with InterMune and as payment of a $7,500,000 installment of the purchase price we owed to InterMune, we issued 358,797 shares of our Series C-2 preferred stock, 358,798 shares of our Series C-3 preferred stock and a warrant to purchase up to 35,552 shares of our Series C-1 preferred stock to InterMune. Robin Steele, InterMune’s Senior Vice President, General Counsel and Corporate Secretary, is designated as a member of our board of directors by InterMune. As described elsewhere in this prospectus, we will owe future cash and equity installment payments to InterMune under this asset purchase agreement upon our achievement of future milestones.

Stockholders Agreements

In connection with the Series C financing transaction described above, on January 31, 2007, we entered into an amended and restated unanimous shareholders agreement and an amended and restated agreement among principal shareholders. These agreements include rights of first refusal, restrictions on transfer, preemptive rights and voting obligations. These agreements terminate automatically upon the closing of this offering.

Registration Rights Agreement

In connection with the Series C financing transaction described above, on January 31, 2007, we entered into an amended and restated registration rights agreement with the holders of our preferred stock. Pursuant to this agreement, under certain circumstances, these stockholders are entitled to require us to register under the securities laws their shares of common stock for resale. See “Description of Capital Stock—Registration Rights” below.

Indemnification

We have agreed to indemnify our directors and officers in certain circumstances. In addition, we have entered into indemnification agreements with each of our directors and certain of our officers. See “Management—Limitation of Liability and Indemnification” above.

Review and Approval of Related Party Transactions

Our board of directors reviews and approves transactions with our directors, officers and holders of more than five percent of our voting securities and their affiliates (each, a related party). Prior to approving any transaction with a related party, our Board of Directors considers the material facts as to the related party’s relationship with the company or interest in the transaction. Related party transactions are not approved unless a majority of the members of our Board of Directors who are not interested in the transaction have approved of the transaction. Following this offering, our audit committee will assume these responsibilities.

 

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PRINCIPAL STOCKHOLDERS

The table below provides certain information about beneficial ownership of our common stock as of June 15, 2007, and as adjusted to reflect the sale of              shares of common stock that we anticipate selling in connection with this offering. The table shows information for:

 

   

each person, or group of affiliated persons, who is known to us to beneficially own more than 5% of our common stock;

 

   

each of our directors and named executive officers; and

 

   

all of our directors and executive officers as a group.

Beneficial ownership and percentage ownership are determined in accordance with the rules of the SEC. In computing the number of shares beneficially owned by a person and the percentage ownership of that person, shares of common stock (on an as-converted basis) underlying options or warrants held by that person that are currently exercisable or exercisable within 60 days of June 15, 2007 are deemed outstanding, but are not deemed outstanding for computing the percentage ownership of any other person. These rules generally attribute beneficial ownership of securities to persons who possess sole or shared voting power or investment power with respect to such securities. Except as otherwise indicated, to our knowledge, all of the shares reflected in the table are shares of our common stock and all persons listed below have sole voting and investment power with respect to the shares beneficially owned by them, subject to applicable community property laws. Percentage of beneficial ownership calculations below are based on 11,457,750 shares of common stock outstanding as of June 15, 2007 and              shares of common stock outstanding after the offering, which assumes:

 

   

the conversion of each outstanding share of our series A convertible preferred stock (on an as-if exchanged basis) into 11.38889 shares of common stock immediately prior to the completion of this offering;

 

   

the conversion of each outstanding share of our series B convertible preferred stock (on an as-if exchanged basis) into 10.31008 shares of common stock immediately prior to the completion of this offering;

 

   

the conversion of each outstanding share of our series C-1 convertible preferred stock (on an as-if exchanged basis) into 1 share of common stock immediately prior to the completion of this offering;

 

   

the conversion of each outstanding share of our series C-2 convertible preferred stock (on an as-if exchanged basis) into 1 share of common stock immediately prior to the completion of this offering; and

 

   

the conversion of each outstanding share of our series C-3 convertible preferred stock (on an as-if exchanged basis) into 1 share of common stock immediately prior to the completion of this offering.

 

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          Percentage of Common Stock
Beneficially Owned

Name and Address of Beneficial Owner(1)

   Number of Shares
Beneficially Owned
   Before Offering     After Offering

Greater than 5% stockholders

       

Brookside Capital Partners Fund, L.P.(2)

   1,757,346    15.2 %  

111 Huntington Avenue

       

Boston, MA 02199

       

InterMune, Inc.(3)

   1,757,344    15.2 %  

3280 Bayshore Boulevard

       

Brisbane, CA 94005

       

Entities affiliated with Skyline Ventures(4)

   1,526,380    13.2 %  

525 University Avenue, Suite 520

       

Palo Alto, CA 94301

       

Entities affiliated with VenGrowth Private Equity Partners(5)

   1,357,823    11.8 %  

105 Adelaide Street West, Suite 1000

       

Toronto, ON M5H 1P9

       

Entities affiliated with OrbiMed Advisors(6)

   1,275,330    11.1 %  

767 Third Avenue

       

New York, NY 10017

       

T 2 C 2 /Bio 2000, société en commandite(7)

   841,554    7.3 %  

1550 Metcalfe Street, Suite 502

       

Montreal, Québec H3A 1X6

       

Canadian Medical Discoveries Fund Inc.(8)

   813,080    7.1 %  

181 Bay Street, Suite 3740

       

Toronto, ON, Canada M5J 2T3

       

Entities directly or indirectly affiliated with Seaflower Ventures(9)

   799,108    7.0 %  

Bay Colony Corporate Center

       

1000 Winter Street, Suite 1000

       

Waltham, MA 02451

       

Entities affiliated with Radius Ventures(10)

   702,938    6.1 %  

400 Madison Avenue

       

New York, NY 10017

       

Named Executive Officers

       

Mark Leuchtenberger(11)

   100,875      *  

Pierre Etienne, M.D. (12)

   112,500      *  

Thomas Parr, Ph.D. (13)

   46,875      *  

George Eldridge(14)

   21,563      *  

Directors

       

William Crouse(15)

   76,721      *  

Dilip Mehta, M.D., Ph.D.(10)(16)

   818,444    7.1 %  

Jay Venkatesan, M.D.(2)

   1,757,346    15.2 %  

Robin Steele(17)

   6,000      *  

Eric Gordon, Ph.D.(4)

   1,526,380    13.2 %  

Jeffrey Courtney(5)

   1,357,823    11.8 %  

Garen Bohlin(18)

   6,250    *    

All executive officers and directors as a group

       

(11 Persons)

   5,830,777    50.6 %  

  Represents beneficial ownership of less than 1% of the shares of Common Stock.
(1)   Except as otherwise indicated, addresses are c/o Targanta Therapeutics Corporation, 222 Third Avenue, Suite 2300, Cambridge, MA 02142.

 

(2)  

Consists of 1,674,390 shares of common stock and warrants exercisable within sixty days to purchase 82,956 shares of common stock held by Brookside Capital Partners Fund, L.P. Domenic J. Ferrante is the managing member of Brookside Capital Management, LLC, the sole general partner of Brookside Capital

 

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Investors, L.P., which is the sole general partner of Brookside Capital Partners Fund, L.P., and as such may be deemed to hold voting and dispositive power with respect to all shares of common stock held by Brookside Capital Partners Fund, L.P. In addition, Jay Venkatesan is a Director of Brookside Capital Partners, and as such may be deemed to hold voting and dispositive power with respect to all shares of common stock held by Brookside Capital Partners Fund, L.P. Each of Mr. Ferrante and Dr. Venkatesan disclaims beneficial ownership of such shares except to the extent of his pecuniary interest, if any.

 

(3)   Consists of 1,674,389 shares of common stock and warrants exercisable within sixty days to purchase 82,955 shares of common stock held by InterMune, Inc. InterMune, Inc. is a publicly held entity.

 

(4)   Consists of 1,119,449 shares of common stock and warrants exercisable within sixty days to purchase 55,462 shares of common stock held by Skyline Venture Partners Qualified Purchaser Fund IV, L.P., 326,742 shares of common stock and warrants to purchase 16,188 shares of common stock held by Skyline Venture Partners Qualified Purchaser Fund III, L.P. and 8,136 shares of common stock and warrants to purchase 403 shares of common stock held by Skyline Venture Partners III, L.P. John G. Freund and Yasunori Kaneka are the Managing Members of Skyline Venture Management III, LLC, which is the general partner of each of Skyline Venture Partners Qualified Purchaser Fund III, L.P. and Skyline Venture Partners III, L.P., and as such Messrs. Freund and Kaneka may be deemed to share voting and dispositive power with respect to all shares of common stock held by Skyline Venture Partners Qualified Purchaser Fund III, L.P. and Skyline Venture Partners III, L.P. John G. Freund and Yasunori Kaneka are the Managing Members of Skyline Venture Management IV, LLC, which is the general partner of Skyline Venture Partners Qualified Purchaser Fund IV, L.P., and as such Messrs. Freund and Kaneka may be deemed to share voting and dispositive power with respect to all shares of common stock held by Skyline Venture Partners Qualified Purchaser Fund IV, L.P. In addition, Eric Gordon is a partner at Skyline ventures, and as such may be deemed to share voting and dispositive power with respect to all shares of common stock held by Skyline Venture Partners III, L.P., Skyline Venture Partners Qualified Purchaser Fund III, L.P. and Skyline Venture Partners Qualified Purchasers Fund IV, L.P. Each of Drs. Freund, Kaneka and Gordon disclaims beneficial ownership of such shares except to the extent of his pecuniary interest, if any.

 

(5)   Consists of 1,218,568 shares of common stock and warrants exercisable within sixty days to purchase 50,859 shares of common stock held by the VenGrowth Advanced Life Sciences Fund Inc. and 84,909 shares of common stock and warrants to purchase 3,487 shares of common stock held by the VenGrowth III Investment Fund Inc. Jeffrey Courtney, one of our directors, is a General Partner, and Luc Marengere, Mike Cohen and Allen Lupyrypa are Managing General Partners of VenGrowth Advanced Life Sciences Fund Inc. and VenGrowth III Investment Fund Inc., and as such Messrs. Courtney, Marengere, Cohen and Lupyrypa may be deemed to share voting and dispositive power with respect to all shares of common stock held by VenGrowth Advanced Life Sciences Fund Inc. and VenGrowth III Investment Fund Inc. Each of Messrs. Courtney, Marengere, Cohen and Lupyrypa disclaims beneficial ownership of such shares except to the extent of his pecuniary interest, if any.

 

(6)   Consists of 1,203,665 shares of common stock and warrants exercisable within sixty days to purchase 59,634 shares of common stock held by Caduceus Private Investments III, LP and 11,463 shares of common stock and warrants to purchase 568 shares of common stock held by OrbiMed Associates III, LP Samuel D. Isaly is the Managing Member of OrbiMed Capital GP III LLC, the general partner of Caduceus Private Investments III, LP and the Managing Member of OrbiMed Advisors LLC, the general partner of OrbiMed Associates III, LP, and as such may be deemed to hold voting and dispositive power with respect to all shares of common stock held by Caduceus Private Investments III, LP and OrbiMed Associates III, LP Mr. Isaly disclaims beneficial ownership of such shares except to the extent of his pecuniary interest, if any.

 

(7)

 

Consists of 811,636 shares of common stock and warrants exercisable within sixty days to purchase 29,918 shares of common stock held by T 2 C 2 /Bio 2000, société en commandite. Dr. Bernard Coupal is the President of Gestion T 2 C 2 /Bio Inc., the general manager of Gestion T 2 C 2 /Bio, s.e.c., which is the general partner of T 2 C 2 /Bio 2000, société en commandite, and as such may be deemed to hold voting and dispositive power with respect to all shares of common stock held by T 2 C 2 /Bio 2000, société en commandite. Dr. Coupal disclaims beneficial ownership of such shares except to the extent of his pecuniary interest, if any.

 

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(8)   Consists of 782,131 shares of common stock and warrants exercisable within sixty days to purchase 30,949 shares of common stock held by Canadian Medical Discoveries Fund, Inc. Steve Hawkins is the President and Chief Executive Officer of Medical Discoveries Management Corp., the manager of Canadian Medical Discoveries Fund, Inc., and as such may be deemed to hold voting and dispositive power with respect to all shares of common stock held by Canadian Medical Discoveries Fund, Inc. Mr. Hawkins disclaims beneficial ownership of such shares except to the extent of his pecuniary interest, if any.

 

(9)   Consists of 709,871 shares of common stock and warrants exercisable within sixty days to purchase 17,114 shares of common stock held by Seaflower Health Ventures III, L.P.; 13,198 shares of common stock and warrants to purchase 89 shares of common stock held by Seaflower Health Ventures III Companion fund, L.P.; and 56,588 shares of common stock and warrants to purchase 2,248 shares of common stock held by J&L Sherblom Family LLC. James Sherblom is the Managing General Partner, Alex Moot is a General Partner, and Zach Jonasson and Amin Ladak are each Principals of Seaflower Ventures, LLC, the general partner of each of Seaflower Health Ventures III, L.P. and Seaflower Health Ventures III Companion Fund, L.P., and as such Messrs. Sherblom, Moot, Jonasson and Ladak may be deemed to share voting and dispositive power with respect to all shares of common stock held by Seaflower Health Ventures III, L.P. and Seaflower Health Ventures III Companion Fund, L.P. Each of Messrs. Sherblom, Moot, Jonasson and Ladak disclaims beneficial ownership of such shares except to the extent of his pecuniary interest, if any. In addition, James Sherblom is the sole Managing Member of J&L Sherblom Family LLC and therefore has voting and dispositive control with respect to all shares of common stock held by J&L Sherblom Family LLC. Mr. Sherblom disclaims sole beneficial ownership of such shares except to the extent of his pecuniary interest, if any.

 

(10)   Consists of 334,878 shares of common stock and warrants exercisable within sixty days to purchase 16,591 shares of common stock held by Radius Venture Partners II, L.P.; 273,822 shares of common stock and warrants to purchase 13,566 shares of common stock held by Radius Venture Partners III Qualified Purchaser, L.P.; and 61,056 shares of common stock and warrants to purchase 3,025 shares of common stock held by Radius Venture Partners III, L.P. Dan Lubin and Jordan Davis are the managing members of Radius Venture Partners II, LLC and Radius Venture Partners III, LLC, which are the general partners of each of Radius Venture Partners II, L.P., Radius Venture Partners III Qualified Purchaser, L.P. and Radius Venture Partners III, L.P., and as such may be deemed to hold voting and dispositive power with respect to all shares of common stock held by such entities. Dr. Mehta is a venture partner with Radius Ventures, and as such may be deemed to hold voting and dispositive power with respect to all shares of common stock held by entities affiliated with Radius Ventures. Each of Messrs. Lubin and Davis and Dr. Mehta disclaims beneficial ownership of such shares except to the extent of his pecuniary interest, if any.

 

(11)   Consists of options exercisable within sixty days to purchase 100,875 shares of common stock held by Mark Leuchtenberger.

 

(12)   Consists of options exercisable within sixty days to purchase 112,500 shares of common stock held by Pierre Etienne, M.D.

 

(13)   Consists of options exercisable within sixty days to purchase 46,875 shares of common stock held by Thomas R. Parr, Jr., Ph.D.

 

(14)   Consists of options exercisable within sixty days to purchase 21,563 shares of common stock held by George Eldridge.

 

(15)   Consists of 46,831 shares of common stock, warrants exercisable within sixty days to purchase 1,765 shares of common stock and options exercisable within sixty days to purchase 28,125 shares of common stock held by William Crouse.

 

(16)   Consists of 95,007 shares of common stock, warrants exercisable within sixty days to purchase 4,074 shares of common stock and options exercisable within sixty days to purchase 16,425 shares of common stock held by Dilip J. Mehta, M.D., Ph.D.

 

(17)   Consists of options exercisable within sixty days to purchase 6,000 shares of common stock held by Robin Steele.

 

(18)   Consists of options exercisable within sixty days to purchase 6,250 shares of common stock held by Garen Bohlin.

 

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DESCRIPTION OF CAPITAL STOCK

General

Our authorized capital stock currently consists of 32,000,000 shares of common stock, par value $0.0001 per share, and 23,505,000 shares of preferred stock, $0.0001 par value per share. Upon completion of this offering our certificate of incorporation will be amended and restated (the Third Amended and Restated Certificate of Incorporation) to provide for total authorized capital consisting of              shares of common stock and              shares of preferred stock. All currently outstanding shares of Series A, B, C-1, C-2 and C-3 preferred stock will be converted upon completion of this offering into shares of our common stock and all currently outstanding shares of special voting stock will be extinguished in connection with our redemption of all currently outstanding exchangeable shares of our two Canadian subsidiary. As a result, upon the consummation of this offering, no shares of preferred stock or special voting stock will be outstanding.

On June 15, 2007, the following numbers of shares of common and preferred stock were outstanding (assuming the exchange of all outstanding exchangeable shares of our two Canadian subsidiaries):

 

Common Stock

   20,230

Series A Preferred Stock

   15,643

Series B Preferred Stock

   143,860

Series C-1 Preferred Stock

   2,361,017

Series C-2 Preferred Stock

   1,081,171

Series C-3 Preferred Stock

   6,333,974

All of the outstanding preferred stock will convert into 11,437,520 shares of common stock upon completion of this offering. Upon completion of this offering, we expect to have approximately              shares of common stock outstanding. As of March 31, 2007, we had 44 shareholders of record.

The following summary of certain provisions of our common and preferred stock does not purport to be complete and is qualified in its entirety by reference to our certificate of incorporation and by-laws as will be in effect at the closing of this offering. You should refer to our certificate of incorporation and our by-laws, both of which are included as exhibits to the registration statement we have filed with the SEC in connection with this offering. The summary below is also qualified by provisions of applicable law.

Common Stock

Holders of common stock are entitled to one vote per share on matters on which our stockholders vote. There are no cumulative voting rights. Holders of common stock are entitled to receive proportionally any dividends declared by our board of directors, out of funds that we may legally use to pay dividends.

In the event of our liquidation or dissolution, holders of our common stock are entitled to share ratably in all assets remaining after payment of all debts and other liabilities, subject to the prior rights of any outstanding preferred stock. Holders of our common stock have no preemptive, subscription, redemption or conversion rights. The shares to be issued by us in this offering will be, when issued and paid for, validly issued, fully paid and nonassessable.

Preferred Stock

We are currently authorized to issue 23,505,000 shares of preferred stock. Upon completion of this offering, all issued and outstanding shares of preferred stock will convert into a total of 11,437,520 shares of common stock. Immediately after this conversion, no shares of preferred stock will be outstanding, and the total number of shares of preferred stock that we are authorized to issue will be reduced to              shares.

 

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Upon completion of this offering, our board of directors may, without further action by our stockholders, from time to time, direct the issuance of shares of preferred stock in series and may, at the time of issuance, determine the rights, preferences and limitations of each series, including voting rights, dividend rights and redemption and liquidation preferences. Satisfaction of any dividend preferences of outstanding shares of preferred stock would reduce the amount of funds available for the payment of dividends on shares of our common stock. Holders of shares of preferred stock may be entitled to receive a preference payment in the event of any liquidation, dissolution or winding-up of our company before any payment is made to the holders of shares of our common stock. In some circumstances, the issuance of shares of preferred stock may render more difficult or tend to discourage a merger, tender offer or proxy contest, the assumption of control by a holder of a large block of our securities or the removal of incumbent management. Upon the affirmative vote of our board of directors, without stockholder approval, we may issue shares of preferred stock with voting and conversion rights which could adversely affect the holders of shares of our common stock.

We have no current intention to issue any of our unissued, authorized shares of preferred stock. However, the issuance of any shares of preferred stock in the future could adversely affect the rights of the holders of our common stock.

Warrants

On January 31, 2007, we issued to certain shareholders warrants to purchase up to an aggregate of 29,855 shares of our common stock at a price per share of $10.45157. The exercise price and number of shares issuable are subject to adjustment in the event of a reorganization, a consolidation or merger, a recapitalization, a reclassification of our securities, a stock split or combination. These warrants, which are currently exercisable, may be exercised on a cash or cashless basis. None of these warrants have been exercised and all are exercisable for a period ending upon the earlier to occur of (i) January 31, 2014 or (ii) five years from the initial public offering of our common stock.

On January 31, 2007, we issued to certain shareholders warrants to purchase up to an aggregate of 333,345 shares of our Series C-1 preferred stock at a price per share of $13.06. We issued additional warrants on February 7, 2006 exercisable for 35,552 shares of our Series C-1 preferred stock and on February 16, 2007 exercisable for an aggregate of 35,079 shares of our Series C-1 preferred stock. The exercise price and number of shares issuable under these warrants are subject to adjustment in the event of a reorganization, a consolidation or merger, a recapitalization, a reclassification of our securities, a stock split or combination. These warrants, which are currently exercisable, may be exercised on a cash or cashless basis. None of these warrants have been exercised and all are exercisable for a period ending upon the earlier to occur of (i) January 31, 2014 or (ii) five years from the initial public offering of our common stock.

On January 31, 2007, our Ontario subsidiary issued to certain of our shareholders warrants to purchase up to an aggregate of 80,378 shares of our Series C-1 preferred stock (on an as-exchanged basis) at a price per share of $13.06. The exercise price and number of shares issuable under these warrants are subject to adjustment in the event of a reorganization, a consolidation or merger, a recapitalization, a reclassification of our securities, a stock split or combination. These warrants may be exercised on a cash or cashless basis. None of these warrants have been exercised and all are exercisable for a period ending upon the earlier to occur of (i) January 31, 2014 or (ii) five years from the initial public offering of our common stock.

Pursuant to the terms of a loan agreement entered into by our Québec subsidiary on April 27, 2004, as amended from time to time, we issued to Investissement Québec, or IQ, a warrant that is presently exercisable (on an as-exchanged basis) for up to 8,200 shares of our Series B preferred stock, at a price per share of CAN $234.00 (or US $202.67 as of March 31, 2007). The exercise price and number of shares issuable are subject to adjustment in the event of the declaration of a stock dividend on our Series B preferred stock. This warrant has not yet been exercised and may only be exercised on a cash basis. IQ may exercise this warrant presently and at any time prior to the first anniversary of the full repayment of the loan extended to our Québec subsidiary (or, if

 

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earlier, the date that is 90 days after IQ’s receipt of audited financial statements for the fiscal year in which the loan is repaid), provided that if we prepay this loan, this warrant is exercisable until the second anniversary of our full repayment of the loan.

Following the consummation of this offering, all outstanding warrants exercisable for shares of our preferred stock will automatically be converted into warrants exercisable for the number of shares of our common stock into which such shares of preferred stock would have converted had such shares been outstanding at the time of this offering.

Registration Rights

The holders of approximately 11,450,852 shares of common stock, assuming the conversion of all our outstanding preferred stock and the exchange of all outstanding exchangeable shares of our two Canadian subsidiaries, to be outstanding following this offering are entitled to demand that we register those shares, known as registrable shares, under the Securities Act commencing six months after the closing of this offering. In addition, if we propose to register any more of our securities under the Securities Act after the closing of this offering, either for our own account or for the account of other security holders, the holders of these rights are entitled to notice of that further registration and are entitled to have their registrable shares included in it. These rights, however, are subject to conditions and limitations, including thresholds as to minimum values of shares required for demand registration, limitations on the number of registrations that may demanded, blackout periods when shares may not be registered and the right of the underwriters of a registered offering of our common stock to limit the number of shares included in the offering. Holders of registrable shares can require us to register shares at our expense and, subject to some conditions and limitations, we are required to use our best efforts to effect requested registrations. Furthermore, holders of these rights may require us to file additional registration statements on Form S-3 for the sale of their registrable shares at any time after we qualify for the use of Form S-3. Holders of these rights do not have the right to have their registrable shares registered under the Securities Act as part of this offering. The holders of warrants to purchase up to 588,564 shares of our common stock, assuming the exercise in full of such warrants and the conversion to common stock of any preferred stock issuable thereto, also hold registration rights on such shares.

Certain anti-takeover provisions of our certificate of incorporation and by-laws

In addition to the board of directors’ ability to issue shares of preferred stock, upon completion of this offering, our certificate of incorporation and by-laws will contain other provisions that are intended to enhance the likelihood of continuity and stability in the composition of the board of directors and that may have the effect of delaying, deferring or preventing a future takeover or change in control of our company unless such takeover or change in control is approved by our board of directors. These provisions include the items described below:

Board composition and filling vacancies . In accordance with our certificate of incorporation, our board is divided into three classes serving staggered three-year terms, with one class being elected each year. Our certificate of incorporation also provides that directors may be removed only for cause and then only by the affirmative vote of the holders of 75% or more of the shares then entitled to vote at an election of directors. Furthermore, any vacancy on our board of directors, however occurring, including a vacancy resulting from an increase in the size of our board, may only be filled by the affirmative vote of a majority of directors then in office even if less than a quorum.

No written consent of stockholders . Our certificate of incorporation provides that all stockholder actions are required to be taken by a vote of the stockholders at an annual or special meeting, and that stockholders may not take any action by written consent in lieu of a meeting. This limit may lengthen the amount of time required to take stockholder actions and would prevent the amendment of our by-laws or removal of directors by our stockholders without holding a meeting of stockholders.

 

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Meetings of stockholders . Our by-laws provide that only a majority of the members of our board of directors then in office may call special meetings of stockholders and only those matters set forth in the notice of the special meeting may be considered or acted upon at a special meeting of stockholders. Our by-laws limit the business that may be conducted at an annual meeting of stockholders to those matters properly brought before the meeting.

Advance notice requirements . Our by-laws establish advance notice procedures with regard to stockholder proposals relating to the nomination of candidates for election as directors or new business to be brought before meetings of our stockholders. These procedures provide that notice of stockholders proposals must be timely given in writing to our corporate secretary prior to the meeting at which the action is to be taken. Generally, to be timely, notice must be received at our principal executive offices not less than 90 days nor more than 120 days prior to the first anniversary date of the annual meeting for the preceding year. The notice much contain certain information specified in the by-laws.

Amendment to certificate of incorporation and by-laws . As required by the Delaware General Corporation Law, any amendment of our certificate of incorporation must first be approved by a majority of our board of directors, and if required by law or our certificate of incorporation, must thereafter be approved by a majority of the outstanding shares entitled to vote on the amendment, and a majority of the outstanding shares of each class entitled to vote thereon as a class, except that the amendment of the provisions relating to stockholder action, directors, limitation of liability and the amendment of our certificate of incorporation must be approved by not less than 75% of the outstanding shares entitled to vote on the amendment, and not less than 75% of the outstanding shares of each class entitled to vote thereon as a class. Our by-laws may be amended by the affirmative vote of a majority vote of the directors then in office, subject to any limitations set forth in the by-laws. Our by-laws may also be amended by the affirmative vote of at least 75% of the outstanding shares entitled to vote on the amendment, or, if the board of directors recommends that the stockholders approve the amendment, by the affirmative vote of the majority of outstanding shares entitled to vote on the amendment, in each case voting together as a single class.

Undesignated preferred stock . Our certificate of incorporation provides for              authorized shares of preferred stock. The existence of authorized but unissued shares of preferred stock may enable our board of directors to render more difficult or to discourage an attempt to obtain control of us by means of a merger, tender offer, proxy contest or otherwise. For example, if in the due exercise of its fiduciary obligations, our board of directors were to determine that a takeover proposal is not in the best interests of us or our stockholders, our board of directors could cause shares of preferred stock to be issued without stockholder approval in one or more private offerings or other transactions that might dilute the voting or other rights of the proposed acquirer or insurgent stockholder or stockholder group. In this regard, our certificate of incorporation grants our board of directors broad power to establish the rights and preferences of authorized and unissued shares of preferred stock. The issuance of shares of preferred stock could decrease the amount of earnings and assets available for distribution to holders of shares of our common stock. The issuance may also adversely affect the rights and powers, including voting rights, of these holders and may have the effect of delaying, deterring or preventing a change in control of our company.

Section 203 of the Delaware General Corporate Law

Upon completion of this offering, we will be subject to the provisions of Section 203 of the Delaware General Corporation Law. In general, Section 203 prohibits a publicly held Delaware corporation from engaging in a “business combination” with an “interested stockholder” for a three-year period following the time that this stockholder becomes an interested stockholder, unless the business combination is approved in a prescribed manner. A “business combination” includes, among other things, a merger, asset or stock sale or other transaction resulting in a financial benefit to the interested stockholder. An “interested stockholder” is a person who, together with affiliates and associates, owns, or did own within three years prior to the determination of interested stockholder status, 15% or more of a corporation’s voting stock. Under Section 203, a business

 

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combination between a corporation and an interested stockholder is prohibited unless it satisfies one of the following conditions:

 

   

before the stockholder became interested, the board of directors approved either the business combination or the transaction which resulted in the stockholder becoming an interested stockholder;

 

   

upon consummation of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the voting stock outstanding, shares owned by persons who are directors and also officers, and employee stock plans, in some instances; or

 

   

at or after the time the stockholder became interested, the business combination was approved by the board of directors of the corporation and authorized at an annual or special meeting of the stockholders by the affirmative vote of at least two-thirds of the outstanding voting stock which is not owned by the interested stockholder.

Limitations on liability and indemnification of officers and directors

Our certificate of incorporation and by-laws limit the liability of our directors and officers to the fullest extent permitted by the Delaware General Corporation Law and provide that we will indemnify our directors and officers to the fullest extent permitted by law. We have entered into indemnification agreements with all of our current directors and statutory officers. We expect to enter into a similar agreement with any new directors. We have obtained director and officer liability insurance to cover liabilities our directors and officers may incur in connection with their services to us, and plan to expand the insurance coverage to include matters arising under the securities laws prior to the completion of this offering.

Nasdaq Global Market Listing

We have applied for quotation of our common stock on The Nasdaq Global Market under the symbol “TARG.”

Transfer Agent and Registrar

The transfer agent and registrar for our common stock is              .

 

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MATERIAL UNITED STATES FEDERAL INCOME AND ESTATE TAX

CONSEQUENCES TO NON-U.S. HOLDERS

The following is a general discussion of material United States federal income and estate tax consequences of the ownership and disposition of our common stock that may be relevant to a non-U.S. holder (as defined below) that acquires our common stock pursuant to this offering. The discussion is based on provisions of the Internal Revenue Code of 1986, as amended, or the Code, applicable United States Treasury regulations promulgated thereunder and United States Internal Revenue Service, or IRS, rulings and pronouncements and judicial decisions, all as in effect on the date of this prospectus and all of which are subject to change (possibly on a retroactive basis) or to different interpretations.

The discussion is limited to non-U.S. holders that hold our common stock as a “capital asset” within the meaning of Section 1221 of the Code (generally, property held for investment). As used in this discussion, the term “non-U.S. holder” means a beneficial owner of our common stock that is not, for United States federal income tax purposes:

 

   

an individual who is a citizen or resident of the United States;

 

   

a corporation (including any entity treated as a corporation for United States federal income tax purposes) created or organized in or under the laws of the United States or any political subdivision thereof;

 

   

an estate the income of which is includible in gross income for United States federal income tax purposes regardless of its source; or

 

   

a trust (1) if a United States court is able to exercise primary supervision over the administration of the trust and one or more United States persons have authority to control all substantial decisions of the trust, or (2) that has in effect a valid election to be treated as a United States person for such purposes.

This discussion specifically does not address United States federal income and estate tax rules applicable to any person who holds our common stock through entities treated as partnerships for United States federal income tax purposes or through entities which are disregarded for United States federal income tax purposes or to such entities themselves. If a partnership (including any entity or arrangement treated as a partnership for such purposes) owns our common stock, the tax treatment of a partner in the partnership will depend upon the status of the partner and the activities of the partnership. A holder that is a partnership, a disregarded entity, and holders of interests in such entities should consult their own tax advisors regarding the tax consequences of the purchase, ownership and disposition of our common stock.

This discussion does not consider:

 

   

any United States state, local or foreign tax consequences;

 

   

any United States federal gift tax consequences;

 

   

any United States federal tax consideration that may be relevant to a non-U.S. holder in light of its particular circumstances or to non-U.S. holders that may be subject to special treatment under United States federal tax laws, including without limitation, banks or other financial institutions, insurance companies, common trust funds, tax-exempt organizations, certain trusts, hybrid entities, certain former citizens or residents of the United States, holders subject to United States federal alternative minimum tax, broker-dealers, and dealers or traders in securities or currencies; or

 

   

special tax rules that may apply to a non-U.S. holder that is deemed to sell our common stock under the constructive sale provisions of the Code and to a non-U.S. holder that holds our common stock as part of a “straddle,” “hedge,” “conversion transaction,” “synthetic security” or other integrated investment.

This discussion is for general purposes only. Prospective investors are urged to consult their own tax advisors regarding the application of the United States federal income and estate tax laws to their particular situations and the consequences under United States federal gift tax laws, as well as foreign, state and local laws and tax treaties.

 

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Dividends

As previously discussed, we do not anticipate paying dividends on our common stock in the foreseeable future. If we pay dividends on our common stock, those payments will constitute dividends for United States federal income tax purposes to the extent paid from our current or accumulated earnings and profits, as determined under United States federal income tax principles. To the extent those distributions exceed our current and accumulated earnings and profits, the distributions will constitute a return of capital and first reduce the non-U.S. holder’s adjusted tax basis, but not below zero, and then will be treated as gain from the sale of stock, as described in the section of this prospectus entitled “Gain on Disposition of Common Stock.”

Dividends paid to a non-U.S. holder generally will be subject to withholding of United States federal income tax at a 30% rate, or a lower rate under an applicable income tax treaty, unless the dividend is effectively connected with the conduct of a trade or business of the non-U.S. holder within the United States or, if an income tax treaty applies, the dividend is attributable to a permanent establishment of the non-U.S. holder within the United States Under applicable United States Treasury regulations, a non-U.S. holder (including, in certain cases of non-U.S. holders that are entities, the owner or owners of such entities) will be required to satisfy certain certification and disclosure requirements in order to claim a reduced rate of withholding pursuant to an applicable income tax treaty. Non-U.S. holders should consult their tax advisors regarding their entitlement to benefits under a relevant income tax treaty.

Dividends that are effectively connected with a non-U.S. holder’s conduct of a trade or business in the United States or, if an income tax treaty applies, are attributable to a permanent establishment in the United States, generally are taxed on a net income basis at the regular graduated United States federal income tax rates in the same manner as if the non-U.S. holder were a resident of the United States. In such cases, we will not have to withhold United States federal income tax if the non-U.S. holder complies with applicable certification and disclosure requirements. In addition, a “branch profits tax” may be imposed at a 30% rate, or a lower rate under an applicable income tax treaty, on dividends received by a foreign corporation that are effectively connected with the conduct of a trade or business in the United States.

In order to claim the benefit of an income tax treaty or to claim exemption from withholding because the income is effectively connected with the conduct of a trade or business in the United States, the non-U.S. holder must provide a properly executed IRS Form W-8BEN, for treaty benefits, or W-8ECI, for effectively connected income (or such successor forms as the IRS may designate), prior to the payment of dividends. These forms must be periodically updated.

A non-U.S. holder that is eligible for a reduced rate of United States federal withholding tax under an income tax treaty may obtain a refund or credit of any excess amounts withheld by timely filing an appropriate claim for a refund together with the required information with the IRS.

Gain on Disposition of Common Stock

A non-U.S. holder generally will not be subject to United States federal income tax with respect to gain realized on a sale or other disposition of our common stock unless one of the following applies:

 

   

the gain is effectively connected with the non-U.S. holder’s conduct of a trade or business in the United States or, if an income tax treaty applies, the gain is attributable to a permanent establishment maintained by the non-U.S. holder in the United States; in these cases, the non-U.S. holder generally will be taxed on its net gain derived from the disposition at the regular graduated rates and in the manner applicable to United States persons and, if the non-U.S. holder is a foreign corporation, the “branch profits tax” described above may also apply;

 

   

the non-U.S. holder is an individual who holds the common stock as a capital asset and is present in the United States for 183 days or more in the taxable year of the disposition and certain other conditions are met; in this case, the non-U.S. holder will be subject to a 30% tax, or such lower rate as may be specified by an applicable income tax treaty, on the gain derived from the sale or other disposition; or

 

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we are or have been a “United States real property holding corporation” for United States federal income tax purposes at any time within the shorter of the five-year period ending on the date of disposition or the period that the non-U.S. holder held our common stock. We do not believe that we have been, currently are, or will become, a United States real property holding corporation. If we were or were to become a United States real property holding corporation at any time during the applicable period, however, any gain recognized on a disposition of our common stock by a non-U.S. holder that did not own (directly, indirectly or constructively) more than 5% of our common stock during the applicable period would not be subject to United States federal income tax, provided that our common stock is “regularly traded on an established securities market” (within the meaning of Section 897(c)(3) of the Code).

Federal Estate Tax

Common stock owned or treated as owned by an individual who is a non-U.S. holder at the time of death will be included in the individual’s gross estate for United States federal estate tax purposes, unless an applicable estate tax or other treaty provides otherwise, and, therefore, such individual’s estate may be subject to United States federal estate tax.

Information Reporting and Backup Withholding Tax

Dividends and proceeds from the sale or other taxable disposition of our common stock are potentially subject to backup withholding at the applicable rate (currently 28%). In general, backup withholding will not apply to dividends on our common stock paid by us or our paying agents, in their capacities as such, to a non-U.S. holder if the holder has provided the required certification that it is a non-U.S. holder and neither we nor our paying agent has actual knowledge (or reason to know) that the holder is a United States holder.

Generally, we must report to the IRS the amount of dividends paid, the name and address of the recipient, and the amount, if any, of tax withheld. These information reporting requirements apply even if withholding is not required. A similar report is sent to the recipient of the dividend. Pursuant to income tax treaties or some other agreements, the IRS may make its reports available to tax authorities in the recipient’s country of residence.

In general, backup withholding and information reporting will not apply to proceeds from the disposition of our common stock paid to a non-U.S. holder if the holder has provided the required certification that it is a non-U.S. holder and neither we nor our paying agent has actual knowledge (or reason to know) that the holder is a United States holder.

Backup withholding is not an additional tax. Rather, the United States federal income tax liability of persons subject to backup withholding will be reduced by the amount of tax withheld. If withholding results in an overpayment of taxes, a refund or credit against the holder’s United States federal income tax liability, if any, may be obtained provided that the required information is furnished to the IRS in a timely manner.

Non-U.S. holders should consult their tax advisors regarding the application of the information reporting and backup withholding rules to them.

Prospective non-U.S. holders of our common stock should consult their tax advisors with respect to the particular tax consequences to them of owning and disposing of our common stock, including the consequences under the laws of any state, local or foreign jurisdiction or under any applicable tax treaty.

 

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SHARES ELIGIBLE FOR FUTURE SALE

Prior to this offering, there was no public market for our common stock. We cannot assure you that a liquid trading market for our common stock will develop or be sustained after this offering. Future sales of substantial amounts of common stock in the public market, or the perception that such sales may occur, could adversely affect the market price of our common stock. Further, since a large number of shares of our common stock will not be available for sale shortly after this offering because of the contractual and legal restrictions on resale described below, sales of substantial amounts of our common stock in the public market after these restrictions lapse, or the perception that such sales may occur, could adversely affect the prevailing market price and our ability to raise equity capital in the future. Although we have applied to have our common stock approved for quotation on The Nasdaq Global Market, we cannot assure you that there will be an active public market for our common stock.

Upon completion of this offering, we will have outstanding an aggregate of              shares of common stock, assuming the issuance of              shares of common stock offered hereby (with no exercise by the underwriters of their over-allotment option) and no exercise of outstanding options or warrants after                 , 2007. Of these shares, the              shares sold in this offering will be freely tradable without restriction or further registration under the Securities Act, except for any shares purchased by our “affiliates,” as that term is defined in Rule 144 under the Securities Act, whose sales would be subject to certain limitations and restrictions described below.

The remaining 11,457,750 shares of common stock held by existing stockholders are deemed “restricted securities” as that term is defined in Rule 144 and may not be resold except pursuant to an effective registration statement or an applicable exemption from registration, including Rule 144, Rule 144(a) and Rule 701. 11,374,891 of these shares will be subject to “lock-up” agreements described below on the effective date of this offering. On the effective date of this offering, there will be 82,859 shares outstanding that are not subject to lock-up agreements and eligible for sale pursuant to Rule 144(k), Rule 144 or Rule 701. Upon expiration of the lock-up agreements 180 days after the effective date of this offering (unless extended in certain specified circumstances described below), 11,374,891 outstanding shares will become eligible for sale, subject in most cases to the limitations of Rule 144. In addition, holders of stock options and warrants could exercise such options or warrants and sell certain of the shares issued upon exercise as described below. See “Underwriting.”

 

Days After Date of this Prospectus

   Shares Eligible
for Sale
  

Comment

Upon Effectiveness

      Shares sold in the offering.

Upon Effectiveness

   82,859    Freely tradable shares saleable under Rule 144(k) that are not subject to the lock-up.

90 Days

   82,859    Shares saleable under Rule 144 and Rule 701 that are not subject to a lock-up.

180 Days

   11,374,891    Lock-up released; shares saleable under Rule 144 and Rule 701.

Thereafter

   0    Restricted securities held for one year or less.

Rule 144

In general, subject to the lock-up agreements discussed below, under Rule 144 as currently in effect, beginning 90 days after the date of this prospectus, a person who has beneficially owned shares of our common stock for at least one year, including an affiliate of ours, would be entitled to sell in “broker’s transactions” or to market makers, within any three-month period, a number of shares that does not exceed the greater of:

 

   

1% of the number of shares of our common stock then outstanding, which will equal approximately              shares immediately after this offering; or

 

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the average weekly trading volume in our common stock on The Nasdaq Global Market during the four calendar weeks preceding the filing of a notice on Form 144 with respect to such sale.

Sales under Rule 144 are generally subject to the availability of current public information about us, as well as certain “manner of sale” and notice requirements.

Rule 144(k)

Under Rule 144(k), a person who is not deemed to have been an affiliate of ours 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 (including the holding period of any prior owner other than an affiliate), is entitled to sell such shares without having to comply with the manner of sale, public information, volume limitation or notice filing provisions of Rule 144. Therefore, unless subject to the lock-up agreements discussed below or otherwise restricted, “144(k) shares” may be sold immediately upon the completion of this offering.

Rule 701

In general, subject to the lock-up agreements discussed below, under Rule 701, any of our employees, directors, officers, consultants or advisors who purchase shares from us in connection with a compensatory stock or option plan or other written agreement before the effective date of this offering is entitled to sell such shares 90 days after the effective date of this offering in reliance on Rule 144, without having to comply with the holding period and notice filing requirements of Rule 144 and, in the case of non-affiliates, without having to comply with the public information, volume limitation or notice filing provisions of Rule 144.

The SEC has indicated that Rule 701 will apply to typical stock options granted by an issuer before it becomes subject to the reporting requirements of the Securities Exchange Act of 1934 (the “ Exchange Act ”), along with the shares acquired upon exercise of such options, including exercises after the date of this prospectus. Securities issued in reliance on Rule 701 are restricted securities and subject to the contractual restrictions described below. Beginning 90 days after the date of this prospectus, these securities may be sold by persons other than affiliates subject only to the manner of sale provisions of Rule 144 and by affiliates without compliance with the one-year minimum holding period requirements under Rule 144.

Lock-up Agreements

Holders of over 95% of our securities (assuming exercise and conversion of all outstanding options and warrants), including all of our executive officers, directors and other senior management have agreed, subject to certain exceptions, not to offer, sell, contract to sell, pledge or otherwise dispose of, directly or indirectly, any shares of our common stock or securities convertible into or exchangeable or exercisable for any shares of our common stock, enter into a transaction that would have the same effect, or enter into any swap, hedge or other arrangement that transfers, in whole or in part, any of the economic consequences of ownership of our common stock, whether any of these transactions are to be settled by delivery of our common stock or other securities, in cash or otherwise, or publicly disclose the intention to make any offer, sale, pledge or disposition, or to enter into any transaction, swap, hedge or other arrangement, without the consent of Credit Suisse Securities (USA) LLC, for a period of 180 days after the date of this prospectus under certain limited circumstances. In the event that either (1) during the last 17 days of the “lock-up” period, we release earnings results or material news or a material event relating to us occurs or (2) 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, then in either case the expiration of the “lock-up” will be extended until the expiration of the 18-day period beginning on the date of the release of the earnings results or the occurrence of the material news or event, as applicable, unless Credit Suisse Securities (USA) LLC waives, in writing, such an extension. To the extent shares of our common stock are released before the expiration of the lock-up period and these shares are sold into the market, the market price of our common stock could decline.

 

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In addition, we have agreed that we will not offer, sell, contract to sell, pledge or otherwise dispose of, directly or indirectly, or file with the Securities and Exchange Commission a registration statement under the Securities Act relating to, any shares of our common stock or securities convertible into or exchangeable or exercisable for any shares of our common stock, or publicly disclose the intention to make any offer, sale, pledge, disposition or filing, without the prior written consent of Credit Suisse Securities (USA) LLC for a period of 180 days after the date of this prospectus, except for the issuance of (i) the shares of our common stock offered in this offering; (ii) the issuance of the shares of our common stock issuable upon the exercise, conversion or exchange of options, warrants, exchangeable shares or other securities outstanding as of the date of this prospectus; (iii) grants of options to purchase shares of our common stock that are reserved for issuance under our stock options plans (provided that the grantee of any such options is subject to a similar lock-up provision); (iv) issuances of shares of our common stock upon the exercise of employee stock options outstanding on the date hereof (provided that the recipient is subject to a similar lock-up provision); and (v) issuances of warrants exercisable for shares of our capital stock in connection with any debt financing arrangements. In the event that either (1) during the last 17 days of the “lock-up” period, we release earnings results or material news or a material event relating to us occurs or (2) 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, then in either case the expiration of the “lock-up” will be extended until the expiration of the 18-day period beginning on the date of the release of the earnings results or the occurrence of the material news or event, as applicable, unless Credit Suisse Securities (USA) LLC waives, in writing, such an extension. To the extent shares of our common stock are released before the expiration of the lock-up period and these shares are sold into the market, the market price of our common stock could decline.

Registration rights

Upon completion of this offering, based upon holdings as of March 31, 2007, the holders of 11,450,852 shares of our common stock (assuming the exchange of all outstanding exchangeable shares of our two Canadian subsidiaries and the conversion of all shares of our preferred stock) have rights to require or participate in the registration of those shares under the Securities Act. Please see “Description of Capital Stock—Registration Rights” for a detailed description of these registration rights.

Stock Options

As of June 15, 2007, options to purchase 1,800,616 shares of our common stock with a weighted average exercise price of $5.06 per share were outstanding. Many of these options are subject to vesting that generally occurs over a period of up to four years following the date of grant. We plan to file registration statements under the Securities Act to register approximately 2,051,749 shares of common stock issuable under our 2005 Stock Option Plan. Those registrations are expected to become effective upon filing with the SEC. Accordingly, common stock registered under those registration statements will, after expiration of any lock-up agreements, be eligible for immediate sale in the open market, except for shares acquired by affiliates, which will be subject to the requirements of Rule 144 described above.

Warrants

As of June 15, 2007, there were fully exercisable warrants to purchase up to 598,751 shares of our common stock (on an as-exchanged and as-converted basis), with a weighted average exercise price of $13.87 per share, all of which will be outstanding upon completion of this offering. Any shares purchased pursuant to the “cashless exercise” feature of these outstanding warrants may be sold only with an effective registration statement for such shares under the Securities Act.

 

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UNDERWRITING

Under the terms and subject to the conditions contained in an underwriting agreement dated             , 2007, we have agreed to sell to the underwriters named below, for whom Credit Suisse Securities (USA) LLC, Cowen and Company, LLC, Lazard Capital Markets LLC and Leerink Swann & Co., Inc. are acting as representatives the following respective numbers of shares of common stock:

 

Underwriter

   Number
of Shares

Credit Suisse Securities (USA) LLC

  

Cowen and Company, LLC

  

Lazard Capital Markets LLC

  

Leerink Swann & Co., Inc.

  
    

Total

  
    

The underwriting agreement provides that the underwriters are obligated to purchase all the shares of common stock in the offering if any are purchased, other than those shares covered by the over-allotment option described below. The underwriting agreement also provides that if an underwriter defaults the purchase commitments of non-defaulting underwriters may be increased or the offering may be terminated.

We have granted to the underwriters a 30-day option to purchase on a pro rata basis up to             additional shares from us at the initial public offering price less the underwriting discounts and commissions. The option may be exercised only to cover any over-allotments of common stock.

The underwriters propose to offer the shares of common stock initially at the public offering price on the cover page of this prospectus and to selling group members at that price less a selling concession of $            per share. The underwriters and selling group members may allow a discount of $            per share on sales to other broker/dealers. After the initial public offering the underwriters may change the public offering price and concession and discount to broker/dealers.

The following table summarizes the compensation and estimated expenses we will pay:

 

     Per Share    Total
     Without
Over-
allotment
   With
Over-
allotment
   Without
Over-
allotment
   With
Over-
allotment

Underwriting discounts and commissions paid by us

   $                 $                 $                 $             

Expenses payable by us

   $                 $                 $                 $             

The underwriters have informed us that they do not expect sales to accounts over which the underwriters have discretionary authority to exceed 5% of the shares of common stock being offered. The underwriters will not confirm sales to any accounts over which they exercise discretionary authority without first receiving a written consent from those accounts.

We have agreed that we will not offer, sell, contract to sell, pledge or otherwise dispose of, directly or indirectly, or file with the Securities and Exchange Commission a registration statement under the Securities Act relating to, any shares of our common stock or securities convertible into or exchangeable or exercisable for any shares of our common stock, or publicly disclose the intention to make any offer, sale, pledge, disposition or filing, without the prior written consent of Credit Suisse Securities (USA) LLC for a period of 180 days after the date of this prospectus , except for the issuance of (i) the shares of our common stock offered in this offering; (ii) the issuance of the shares of our common stock issuable upon the exercises conversion or exchange of

 

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options, warrants, exchangeable shares of other securities outstanding on the date of this prospectus; (iii) grants of options to purchase shares of our common stock that are reserved for issuance under our stock option plans (provided that the grantee of any such options is subject to a similar lock-up provision); (iv) issuances of shares of our common stock upon the exercise of employee stock options outstanding on the date hereof (provided that the recipient is subject to a similar lock-up provision); and (v) issuances of warrants exercisable for shares of our capital stock in connection with any debt financing arrangements. However, in the event that either (1) during the last 17 days of the “lock-up” period, we release earnings results or material news or a material event relating to us occurs or (2) 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, then in either case the expiration of the “lock-up” will be extended until the expiration of the 18-day period beginning on the date of the release of the earnings results or the occurrence of the material news or event, as applicable, unless Credit Suisse Securities (USA) LLC waives, in writing, such an extension.

Holders of over 95% of our securities (assuming exercise and conversion of all outstanding options and warrants), including our executive officers, directors and other senior management have agreed, subject to certain exceptions, that they will not offer, sell, contract to sell, pledge or otherwise dispose of, directly or indirectly, any shares of our common stock or securities convertible into or exchangeable or exercisable for any shares of our common stock, enter into a transaction that would have the same effect, or enter into any swap, hedge or other arrangement that transfers, in whole or in part, any of the economic consequences of ownership of our common stock, whether any of these transactions are to be settled by delivery of our common stock or other securities, in cash or otherwise, or publicly disclose the intention to make any offer, sale, pledge or disposition, or to enter into any transaction, swap, hedge or other arrangement, without, in each case, the prior written consent of Credit Suisse Securities (USA) LLC for a period of 180 days after the date of this prospectus. However, in the event that either (1) during the last 17 days of the “lock-up” period, we release earnings results or material news or a material event relating to us occurs or (2) 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, then in either case the expiration of the “lock-up” will be extended until the expiration of the 18-day period beginning on the date of the release of the earnings results or the occurrence of the material news or event, as applicable, unless Credit Suisse Securities (USA) LLC waives, in writing, such an extension.

We have agreed to indemnify the underwriters against liabilities under the Securities Act, or contribute to payments that the underwriters may be required to make in that respect.

We have applied to list the shares of common stock on The Nasdaq Global Market, subject to official notice of issuance, under the symbol “TARG.”

Lazard Frères & Co. LLC referred this transaction to Lazard Capital Markets LLC and will receive a referral fee from Lazard Capital Markets LLC in connection herewith.

From time to time in the ordinary course of their respective businesses, certain of the underwriters and their respective affiliates have provided and may in the future provide financial advisory, commercial banking and/or investment banking services for us for which they have received or will receive customary compensation.

Prior to this offering, there was no public market for our common stock. The initial public offering price will be determined by negotiation by us and the representatives of the underwriters. The principal factors to be considered in determining the initial public offering price include:

 

   

the information set forth in this prospectus and otherwise available to the representatives;

 

   

our history and prospects and the history of, and prospects for, the industry in which we compete;

 

   

our past and present financial performance and an assessment of our management;

 

   

our prospects for future earnings and the present state of our development;

 

   

the general condition of the securities markets at the time of this offering;

 

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the recent market prices of, and the demand for, publicly traded common stock of generally comparable companies; and

 

   

other factors deemed relevant by the underwriters and us.

In connection with the offering the underwriters may engage in stabilizing transactions, over-allotment transactions, syndicate covering transactions and penalty bids.

 

   

Stabilizing transactions permit bids to purchase the underlying security so long as the stabilizing bids do not exceed a specified maximum.

 

   

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

 

   

Syndicate covering transactions involve purchases of the common stock in the open market after the distribution has been completed in order to cover syndicate short positions. In determining the source of shares to close out the short position, the underwriters will consider, among other things, the price of shares available for purchase in the open market as compared to the price at which they may purchase shares through the over-allotment option. If the underwriters sell more shares than could be covered by the over-allotment option, a naked short position, the position can only be closed out by buying shares in the open market. A naked short position is more likely to be created if the underwriters are concerned that there could be downward pressure on the price of the shares in the open market after pricing that could adversely affect investors who purchase in the offering.

 

   

Penalty bids permit the representatives to reclaim a selling concession from a syndicate member when the common stock originally sold by the syndicate member is purchased in a stabilizing or syndicate covering transaction to cover syndicate short positions.

These stabilizing transactions, syndicate covering transactions and penalty bids may have the effect of raising or maintaining the market price of our common stock or preventing or retarding a decline in the market price of the common stock. As a result the price of our common stock may be higher than the price that might otherwise exist in the open market. These transactions may be effected on The Nasdaq Global Market or otherwise and, if commenced, may be discontinued at any time.

A prospectus in electronic format may be made available on the web sites 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.

 

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NOTICE TO INVESTORS

Notice to Investors Resident in Canada

Resale Restrictions

The distribution of the shares of our common stock in Canada is being made only on a private placement basis exempt from the requirement that we prepare and file a prospectus with the securities regulatory authorities in each province where trades of our common stock are made. Any resale of the shares of our common stock in Canada must be made under applicable securities laws which will vary depending on the relevant jurisdiction, and which may require resales to be made under available statutory exemptions or under a discretionary exemption granted by the applicable Canadian securities regulatory authority. Purchasers are advised to seek legal advice prior to any resale of the shares of our common stock.

Representations of Purchasers

By purchasing shares of our common stock in Canada and accepting a purchase confirmation a purchaser is representing to us and the dealer from whom the purchase confirmation is received that:

 

   

the purchaser is entitled under applicable provincial securities laws to purchase the shares of our common stock without the benefit of a prospectus qualified under those securities laws,

 

   

where required by law, that the purchaser is purchasing as principal and not as agent,

 

   

the purchaser has reviewed the text above under Resale Restrictions, and

 

   

the purchaser acknowledges and consents to the provision of specified information concerning its purchase of the shares of our common stock to the regulatory authority that by law is entitled to collect the information.

Further details concerning the legal authority for this information is available on request.

Rights of Action—Ontario Purchasers Only

Under Ontario securities legislation, certain purchasers who purchase a security offered by this prospectus during the period of distribution will have a statutory right of action for damages, or while still the owner of the shares of our common stock, for rescission against us in the event that this prospectus contains a misrepresentation without regard to whether the purchaser relied on the misrepresentation. The right of action for damages is exercisable not later than the earlier of 180 days from the date the purchaser first had knowledge of the facts giving rise to the cause of action and three years from the date on which payment is made for the shares of our common stock. The right of action for rescission is exercisable not later than 180 days from the date on which payment is made for the shares of our common stock. If a purchaser elects to exercise the right of action for rescission, the purchaser will have no right of action for damages against us. In no case will the amount recoverable in any action exceed the price at which the shares of our common stock were offered to the purchaser and if the purchaser is shown to have purchased the securities with knowledge of the misrepresentation, we will have no liability. In the case of an action for damages, we will not be liable for all or any portion of the damages that are proven to not represent the depreciation in value of the shares of our common stock as a result of the misrepresentation relied upon. These rights are in addition to, and without derogation from, any other rights or remedies available at law to an Ontario purchaser. The foregoing is a summary of the rights available to an Ontario purchaser. Ontario purchasers should refer to the complete text of the relevant statutory provisions.

 

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Enforcement of Legal Rights

All of our directors and officers as well as the experts named herein may be located outside of Canada and, as a result, it may not be possible for Canadian purchasers to effect service of process within Canada upon us or those persons. All or a substantial portion of our assets and the assets of those persons may be located outside of Canada and, as a result, it may not be possible to satisfy a judgment against us or those persons in Canada or to enforce a judgment obtained in Canadian courts against us or those persons outside of Canada.

Taxation and Eligibility for Investment

Canadian purchasers of shares of our common stock should consult their own legal and tax advisors with respect to the tax consequences of an investment in shares of our common stock in their particular circumstances and about the eligibility of the shares of our commons tock for investment by the purchaser under relevant Canadian legislation.

Notice to Residents of European Economic Area

In relation to each Member State of the European Economic Area which has implemented the Prospectus Directive (each, a “ Relevant Member State ”), each Underwriter represents and agrees that with effect from and including the date on which the Prospectus Directive is implemented in that Relevant Member State (the “ Relevant Implementation Date ”) it has not made and will not make an offer of Securities to the public in that Relevant Member State prior to the publication of a prospectus in relation to the Securities which has been approved by the competent authority in that Relevant Member State or, where appropriate, approved in another Relevant Member State and notified to the competent authority in that Relevant Member State, all in accordance with the Prospectus Directive, except that it may, with effect from and including the Relevant Implementation Date, make an offer of Securities to the public in that Relevant Member State at any time,

 

  (a)   to legal entities which are authorized or regulated to operate in the financial markets or, if not so authorized or regulated, whose corporate purpose is solely to invest in securities;

 

  (b)   to any legal entity which has two or more of (1) an average of at least 250 employees during the last financial year; (2) a total balance sheet of more than €43,000,000 and (3) an annual net turnover of more than €50,000,000, as shown in its last annual or consolidated accounts;

 

  (c)   to fewer than 100 natural or legal persons (other than qualified investors as defined in the Prospectus Directive) subject to obtaining the prior consent of the manager for any such offer; or

 

  (d)   in any other circumstances which do not require the publication by the Issuer of a prospectus pursuant to Article 3 of the Prospectus Directive.

For the purposes of this provision, the expression an “offer of Shares to the public” in relation to any Shares in any Relevant Member State means the communication in any form and by any means of sufficient information on the terms of the offer and the Shares to be offered so as to enable an investor to decide to purchase or subscribe the Shares, as the same may be varied in that Member State by any measure implementing the Prospectus Directive in that Member State and the expression “ Prospectus Directive ” means Directive 2003/71/EC and includes any relevant implementing measure in each Relevant Member State.

 

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Notice to Residents of the United Kingdom

Each of the underwriters severally represents, warrants and agrees as follows:

 

  (a)   it has only communicated or caused to be communicated and will only communicate or cause to be communicated an invitation or inducement to engage in investment activity (within the meaning of section 21 of FSMA) to persons who have professional experience in matters relating to investments falling with Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 or in circumstances in which section 21 of FSMA does not apply to the company; and

 

  (b)   it has complied with, and will comply with all applicable provisions of FSMA with respect to anything done by it in relation to the shares of our common stock in, from or otherwise involving the United Kingdom.

Notice to Residents of Japan

The underwriters will not offer or sell any of the shares of our common stock directly or indirectly in Japan or to, or for the benefit of any Japanese person or to others, for re-offering or re-sale directly or indirectly in Japan or to any Japanese person, except in each case pursuant to an exemption from the registration requirements of, and otherwise in compliance with, the Securities and Exchange Law of Japan and any other applicable laws and regulations of Japan. For purposes of this paragraph, “ Japanese person ” means any person resident in Japan, including any corporation or other entity organized under the laws of Japan.

Notice to Residents of Hong Kong

The underwriters and each of their affiliates have not (i) offered or sold, and will not offer or sell, in Hong Kong, by means of any document, the shares of our common stock other than (a) to “professional investors” as defined in the Securities and Futures Ordinance (Cap.571) of Hong Kong and any rules made under that Ordinance or (b) in other circumstances which do not result in the document being a “prospectus” as defined in the Companies Ordinance (Cap. 32) of Hong Kong or which do not constitute an offer to the public within the meaning of that Ordinance or (ii) issued or had in its possession for the purposes of issue, and will not issue or have in its possession for the purposes of issue, whether in Hong Kong or elsewhere any advertisement, invitation or document relating to the shares of our common stock which is directed at, or the contents of which are likely to be accessed or read by, the public in Hong Kong (except if permitted to do so under the securities laws of Hong Kong) other than with respect to our securities which are or are intended to be disposed of only to persons outside Hong Kong or only to “professional investors” as defined in the Securities and Futures Ordinance any rules made under that Ordinance. The contents of this document have not been reviewed by any regulatory authority in Hong Kong. You are advised to exercise caution in relation to the offer. If you are in any doubt about any of the contents of this document, you should obtain independent professional advice.

Notice to Residents of Singapore

This prospectus or any other offering material relating to the shares of our common stock has not been and will not be registered as a prospectus with the Monetary Authority of Singapore, and the shares of our common stock will be offered in Singapore pursuant to exemptions under Section 274 and Section 275 of the Securities and Futures Act, Chapter 289 of Singapore (the “ Securities and Futures Act ”). Accordingly, the shares of our common stock may not be offered or sold, or be the subject of an invitation for subscription or purchase, nor may this prospectus or any other offering material relating to the shares of our common stock be circulated or distributed, whether directly or indirectly, to the public or any member of the public in Singapore other than (a) to an institutional investor or other person specified in Section 274 of the Securities and Futures Act, (b) to a sophisticated investor, and in accordance with the conditions specified in Section 275 of the Securities and

 

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Futures Act or (c) otherwise pursuant to, and in accordance with the conditions of, any other applicable provision of the Securities and Futures Act.

Notice to Residents of Germany

Each person who is in possession of this prospectus is aware of the fact that no German sales prospectus (Verkaufsprospekt) within the meaning of the Securities Sales Prospectus Act (Wertpapier-Verkaufsprospektgesetz, the “ Act ”) of the Federal Republic of Germany has been or will be published with respect to the shares of our common stock. In particular, each underwriter has represented that it has not engaged and has agreed that it will not engage in a public offering in (offentliches Angebot) within the meaning of the Act with respect to any of the shares of our common stock otherwise than in accordance with the Act and all other applicable legal and regulatory requirements.

Notice to Residents of France

The shares of our common stock are being issued and sold outside the Republic of France and that, in connection with their initial distribution, it has not offered or sold and will not offer or sell, directly or indirectly, any shares of our common stock to the public in the Republic of France, and that it has not distributed and will not distribute or cause to be distributed to the public in the Republic of France this [prospectus] or any other offering material relating to the shares of our common stock, and that such offers, sales and distributions have been and will be made in the Republic of France only to qualified investors (investisseurs qualifiés) in accordance with Article L.411-2 of the Monetary and Financial Code and decrét no. 98-880 dated 1st October, 1998.

Notice to Residents of the Netherlands

The shares of our common stock may not be offered, sold, transferred or delivered in or from the Netherlands as part of their initial distribution or at any time thereafter, directly or indirectly, other than to, individuals or legal entities situated in The Netherlands who or which trade or invest in securities in the conduct of a business or profession (which includes banks, securities intermediaries (including dealers and brokers), insurance companies, pension funds, collective investment institution, central governments, large international and supranational organizations, other institutional investors and other parties, including treasury departments of commercial enterprises, which as an ancillary activity regularly invest in securities; hereinafter, “Professional Investors”), provided that in the offer, prospectus and in any other documents or advertisements in which a forthcoming offering of the shares of our common stock is publicly announced (whether electronically or otherwise) in The Netherlands it is stated that such offer is and will be exclusively made to such Professional Investors. Individual or legal entities who are not Professional Investors may not participate in the offering of the shares of our common stock, and this prospectus or any other offering material relating to the shares of our common stock may not be considered an offer or the prospect of an offer to sell or exchange the shares of our common stock.

 

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LEGAL MATTERS

Choate, Hall & Stewart LLP, Boston, Massachusetts, has passed upon the validity of the shares of common stock offered hereby. Dewey Ballantine LLP, New York, New York, is counsel for the underwriters in connection with this offering.

EXPERTS

The consolidated financial statements of Targanta Therapeutics Corporation at December 31, 2005 and 2006, and for the years ended May 31, 2004 and 2005, the seven months ended December 31, 2005, the year ended December 31, 2006 and for the period from May 20, 1997 (date of inception) through December 31, 2006 appearing in this prospectus and registration statement have been audited by Ernst & Young LLP, independent registered public accounting firm, as set forth in their report thereon appearing elsewhere herein, and are included in reliance upon such report given on the authority of such firm as experts in accounting and auditing.

WHERE YOU CAN FIND MORE INFORMATION

We have filed with the SEC a registration statement on Form S-1 (File Number 333-142842) under the Securities Act with respect to the shares of common stock we are offering by this prospectus. This prospectus, which constitutes part of the registration statement, does not contain all of the information included in the registration statement and its exhibits and schedules. For further information pertaining to us and our common stock, you should refer to the registration statement and to its exhibits and schedules. Whenever we make reference in this prospectus to any of our contracts, agreements or other documents, the references are not necessarily complete, and you should refer to the exhibits attached to the registration statement for copies of the actual contract, agreement or other document.

Upon the closing of the offering, we will be subject to the informational requirements of the Exchange Act and we intend to file annual, quarterly and current reports, proxy statements and other information with the SEC. You can read our SEC filings, including the registration statement, through the Internet at the SEC’s website at www.sec.gov. You may also read and copy any document we file with the SEC at its public reference facility at 100 F Street, N.E., Washington, D.C., 20549.

You may also obtain copies of the documents at prescribed rates by writing to the Public Reference Section of the SEC at 100 F Street, N.E., Washington, D.C., 20549. Please call the SEC at 1-800-SEC-0330 for further information on the operation of the public reference facility.

 

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Targanta Therapeutics Corporation

(A development-stage company)

Index

 

     Page
Report of independent registered public accounting firm    F-2
Consolidated balance sheets as of December 31, 2005 (Restated) and 2006 (Restated), and March 31, 2007 (unaudited) and March 31, 2007 (pro forma, unaudited)    F-3
Consolidated statements of operations for the years ended May 31, 2004 (Restated) and 2005 (Restated), the seven-months ended December 31, 2005 (Restated), the year ended December 31, 2006 (Restated), the three months ended March 31, 2006 and 2007 (unaudited) and the period from May 20, 1997 (date of inception) through March 31, 2007 (unaudited)    F-4
Consolidated statements of redeemable convertible preferred stock and stockholders’ (deficit) equity for the years ended May 31, 2004 (Restated) and 2005 (Restated), the seven-months ended December 31, 2005 (Restated), the year ended December 31, 2006 (Restated), the three months ended March 31, 2007 (unaudited) and the period from May 20, 1997 (date of inception) through March 31, 2007 (unaudited)    F-5
Consolidated statements of cash flows for the years ended May 31, 2004 (Restated) and 2005 (Restated), the seven-months ended December 31, 2005 (Restated), the year ended December 31, 2006 (Restated), the three months ended March 31, 2006 and 2007 (unaudited) and the period from May 20, 1997 (date of inception) through March 31, 2007 (unaudited)    F-8
Notes to consolidated financial statements (Restated)    F-10

 

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Table of Contents

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

The Board of Directors and Stockholders of

Targanta Therapeutics Corporation

We have audited the accompanying consolidated balance sheets of Targanta Therapeutics Corporation (a development-stage company) as of December 31, 2005 and 2006, and the related consolidated statements of operations, redeemable convertible preferred stock and stockholders’ (deficit) equity, and cash flows for the years ended May 31, 2004 and 2005, the seven-months ended December 31, 2005, the year ended December 31, 2006, and the period from May 20, 1997 (date of inception) to December 31, 2006. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. We were not engaged to perform an audit of the Company’s internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. 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, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the consolidated financial position of the Company at December 31, 2005 and 2006, and the consolidated results of its operations and its cash flows for the years ended May 31, 2004 and 2005, the seven-months ended December 31, 2005, the year ended December 31, 2006, and the period from May 20, 1997 (date of inception) to December 31, 2006, in conformity with U.S. generally accepted accounting principles.

Our previous audit report dated April 20, 2007, except Note 19.A as to which the date was May 8, 2007, has been withdrawn and, as more fully described in Note 2.A to the consolidated financial statements, the accompanying consolidated balance sheets of the Company as of December 31, 2005 and 2006, and the related consolidated statements of operations, redeemable convertible preferred stock and stockholders’ (deficit) equity, and cash flows for the years ended May 31, 2004 and 2005, the seven-months ended December 31, 2005, the year ended December 31, 2006, and the period from May 20, 1997 (date of inception) to December 31, 2006 have been restated.

/s/    Ernst & Young LLP

Chartered Accountants

Montreal, Canada

April 20, 2007, except for Note 19.A as to which the

date is May 8, 2007 and Note 2.A as to which

the date is June 22, 2007

 

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Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Consolidated Balance Sheets

 

    December 31,     March 31, 2007  
    2005     2006    

Actual

(unaudited)

   

Pro forma

(unaudited)

 
Assets   Restated
(Note 2)
    Restated
(Note 2)
             

Current assets:

       

Cash and cash equivalents

  $ 11,780,591     $ 12,103,702     $ 57,599,415     $ 57,599,415  

Short-term investments

    428,816       429,074       433,050       433,050  

Investment tax credits recoverable

    2,332,170       1,033,210       1,116,534       1,116,534  

Prepaid expenses and other current assets

    171,771       343,777       1,408,758       1,408,758  
                               

Total current assets

    14,713,348       13,909,763       60,557,757       60,557,757  

Property and equipment, net

    1,165,138       884,042       898,687       898,687  

Deferred financing costs

    276,564       373,022       82,456       82,456  

Deposits

    14,226       47,476       47,608       47,608  
                               

Total assets

  $ 16,169,276     $ 15,214,303     $ 61,586,508     $ 61,586,508  
                               

Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ (Deficit) Equity

       

Current liabilities:

       

Accounts payable

  $ 402,156     $ 1,287,669     $ 830,267     $ 830,267  

Accrued expenses

    3,127,644       1,359,553       1,686,152       1,686,152  

Income tax payable

    —         —         2,336,457       2,336,457  

Deferred income tax

    —         2,212,530       —         —    

Current portion of capital lease obligations

    80,868       —         —         —    

Current portion of convertible debt

    839,350       18,945,163       —         —    
                               

Total current liabilities

    4,450,018       23,804,915       4,852,876       4,852,876  

Note payable

    6,528,886       7,297,345       7,564,609       7,564,609  

Deferred rent

    41,318       44,635       45,584       45,584  

Deferred income tax

    1,418,409       —         —         —    

Long-term portion of convertible debt

    8,863,096       9,570,903       —         —    

Warrants to purchase shares subject to redemption

    721,292       1,012,175       1,180,713       1,180,713  

Series B Redeemable Convertible Preferred Stock, par value $0.0001; authorized 333,333 shares at December 31, 2005, 455,333 shares at December 31, 2006 and no shares at March 31, 2007 (actual and pro forma), 115,169 shares issued and outstanding at December 31, 2005 and 2006 and no shares at March 31, 2007 (actual and pro forma)

    13,093,821       14,973,548       —         —    

Commitments (Note 8)

       

Stockholders’ (deficit) equity:

       

Series A Convertible Preferred Stock, par value $0.0001; authorized 16,667 shares at December 31, 2005 and 2006 and 20,000 shares at March 31, 2007 (actual) and no shares pro forma, 15,643 shares issued and outstanding at December 31, 2005 and 2006 and March 31, 2007 (actual) and no shares at March 31, 2007 (pro forma)

    1,458,208       1,458,208       1,458,208       —    

Series B Convertible Preferred Stock, par value $0.0001; authorized 245,000 shares at March 31, 2007 (actual) and no shares pro forma, 143,860 shares issued and outstanding at March 31, 2007 (actual) and none at March 31, 2007 (pro forma)

    —         —         15,198,469       —    

Series C Convertible Preferred Stock, par value $0.0001; authorized 14,300,000 shares at March 31, 2007 (actual) and no shares pro forma, 9,776,162 shares issued and outstanding at March 31, 2007 (actual) and none at March 31, 2007 (pro forma)

    —         —         97,420,929       —    

Common Stock, par value $0.0001; authorized 433,333 shares at December 31, 2005, 555,333 shares at December 31, 2006 and 32,000,000 shares at March 31, 2007 (actual and pro forma), and 20,230 shares issued and outstanding at December 31, 2005 and 2006 and March 31, 2007 (actual) and 11,457,750 shares at March 31, 2007 (pro forma)

    2       2       2       1,146  

Additional paid-in capital

    11,924,734       19,117,284       14,648,545       128,725,007  

Accumulated other comprehensive income

    1,111,959       1,518,914       1,518,914       1,518,914  

Deficit accumulated during the development stage

    (33,442,467 )     (63,583,626 )     (82,302,341 )     (82,302,341 )
                               

Total stockholders’ (deficit) equity

    (18,947,564 )     (41,489,218 )     47,942,726       47,942,726  
                               

Total liabilities, redeemable convertible preferred stock and stockholders’ (deficit) equity

  $ 16,169,276     $ 15,214,303     $ 61,586,508     $ 61,586,508  
                               

The accompanying notes are an integral part of these consolidated financial statements.

 

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Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Consolidated Statements of Operations

 

   

Year Ended

May 31,

2004

   

Year Ended

May 31,

2005

   

Seven Months
Ended

December 31,

2005

   

Year Ended

December 31,

2006

    Three Months Ended
March 31,
   

For the
Period from
May 20, 1997
(date of
inception)
through
March 31, 2007

 
            2006     2007    
    Restated
(Note 2)
    Restated
(Note 2)
    Restated
(Note 2)
    Restated
(Note 2)
    (unaudited)     (unaudited)  

Operating expenses

             

Research and development(1)

  $ 5,197,778     $ 4,502,959     $ 2,318,670     $ 11,455,780     $ 2,179,176     $ 5,439,450     $ 36,186,188  

Acquired in-process research and development

    —         —         11,847,582       —         —         9,500,000       21,347,582  

General and administrative(1)

    1,505,842       1,387,976       2,108,128       3,352,635       560,883       1,934,559       13,063,888  
                                                       

Total operating expenses

    6,703,620       5,890,935       16,274,380       14,808,415       2,740,059       16,874,009       70,597,658  
                                                       

Other income (expense)

             

Interest income

    124,701       78,032       31,165       280,402       84,075       458,134       1,372,984  

Interest expense

    (41,418 )     (211,006 )     (851,639 )     (14,968,026 )     (4,229,156 )     (2,209,559 )     (18,434,335 )

Foreign exchange gain (loss)

    —         —         15,313       (214,436 )     (9,161 )     (64,418 )     (263,541 )

Gain on disposal of property and equipment

    —         —         —         —         —         —         47,011  
                                                       

Other income (expense), net

    83,283       (132,974 )     (805,161 )     (14,902,060 )     (4,154,242 )     (1,815,843 )     (17,277,881 )
                                                       

Loss before income tax (expense) benefit

    (6,620,337 )     (6,023,909 )     (17,079,541 )     (29,710,475 )     (6,894,301 )     (18,689,852 )     (87,875,539 )

Income tax (expense) benefit

    776,167       758,752       1,490,656       (430,684 )     (98,426 )     (28,863 )     5,573,198  
                                                       

Net loss

  $ (5,844,170 )   $ (5,265,157 )   $ (15,588,885 )   $ (30,141,159 )   $ (6,992,727 )   $ (18,718,715 )   $ (82,302,341 )
                                                       

Net loss per share—basic and diluted

  $ (344.16 )   $ (305.33 )   $ (791.46 )   $ (1,582.84 )   $ (368.89 )   $ (936.41 )  
                                                 

Weighted average number of common shares used in net loss per share—basic and diluted

    20,209       20,216       20,230       20,230       20,230       20,230    

Unaudited

             

Pro forma net loss per share—basic and diluted

        $ (122.86 )     $ (2.23 )  

Shares used in computing pro forma net loss per share—basic and diluted

          298,918         11,457,750    

(1)    Amounts include stock-based compensation expense, as follows:

      

   

Research and development

  $ 161,471     $ 176,372     $ 109,340     $ 194,024     $ 66,714     $ 8,520     $ 769,070  

General and administrative

    153,936       170,310       89,698       153,501       16,722       10,992       691,475  

The accompanying notes are an integral part of these consolidated financial statements.

 

F-4


Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders' (Deficit) Equity

 

   

Series B

redeemable

convertible

preferred stock

 

Series A
convertible

preferred stock

 

Series B
convertible

preferred stock

 

Series C
convertible

preferred stock

  Common stock  

Additional

paid-in
capital

   

Accumulated

deficit

   

Other
comprehensive

income (loss)

   

Stockholders’

(deficit)
equity

 
    Shares   Amount   Shares   Amount   Shares   Amount   Shares   Amount   Shares   Amount        

Issuance of common stock to founders

  —     $ —     —     $ —     —     $ —     —     $ —     5,568   $ 53   $ —       $ —       $ —       $ 53  

Issuance of Series A convertible preferred stock,
net of issuance costs of $39,461

  —       —     15,643     1,542,372   —       —     —       —     —       —       —         —         —         1,542,372  

Foreign currency translation adjustments

  —       —     —       —     —       —     —       —     —       —       —         —         (30,482 )     (30,482 )

Net loss

  —       —     —       —     —       —     —       —     —       —       —         (195,820 )     —         (195,820 )
                                                                                 

Balance at May 31, 1998

  —       —     15,643     1,542,372   —       —     —       —     5,568     53     —         (195,820 )     (30,482 )     1,316,123  

Stock-based compensation expense

  —       —     —       —     —       —     —       —     —       —       7,903       —         —         7,903  

Foreign currency translation adjustments

  —       —     —       —     —       —     —       —     —       —       —         —         (26,624 )     (26,624 )

Net loss

  —       —     —       —     —       —     —       —     —       —       —         (409,461 )     —         (409,461 )
                                                                                 

Balance at May 31, 1999

  —       —     15,643     1,542,372   —       —     —       —     5,568     53     7,903       (605,281 )     (57,106 )     887,941  

Issuance of common stock, net of issuance costs
of $82,903

  —       —     —       —     —       —     —       —     13,332     2,630,433     —         —         —         2,630,433  

Stock-based compensation expense

  —       —     —       —     —       —     —       —     —       —       13,830       —         —         13,830  

Foreign currency translation adjustments

  —       —     —       —     —       —     —       —     —       —       —         —         (40,246 )     (40,246 )

Net loss

  —       —     —       —     —       —     —       —     —       —       —         (818,053 )     —         (818,053 )
                                                                                 

Balance at May 31, 2000

  —       —     15,643     1,542,372   —       —     —       —     18,900     2,630,486     21,733       (1,423,334 )     (97,352 )     2,673,905  

Issuance of common stock

  —       —     —       —     —       —     —       —     6     680     —         —         —         680  

Stock-based compensation expense

  —       —     —       —     —       —     —       —     —       —       36,943       —         —         36,943  

Foreign currency translation adjustments

  —       —     —       —     —       —     —       —     —       —       —         —         (65,300 )     (65,300 )

Net loss

  —       —     —       —     —       —     —       —     —       —       —         (916,238 )     —         (916,238 )
                                                                                 

Balance at May 31, 2001

  —       —     15,643     1,542,372   —       —     —       —     18,906     2,631,166     58,676       (2,339,572 )     (162,652 )     1,729,990  

Exercise of stock options

  —       —     —       —     —       —     —       —     2     263     —         —         —         263  

Issuance of Series B redeemable convertible preferred stock, net of issuance costs of $121,403

  34,186     4,906,249   —       —     —       —     —       —     —       —       —         —         —         —    

Accretion of dividends on Series B redeemable convertible preferred stock

  —       157,301   —       —     —       —     —       —     —       —       (157,301 )     —         —         (157,301 )

Stock-based compensation expense

  —       —     —       —     —       —     —       —     —       —       54,117       —         —         54,117  

Foreign currency translation adjustments

  —       —     —       —     —       —     —       —     —       —       —         —         189,227       189,227  

Net loss

  —       —     —       —     —       —     —       —     —       —       —         (1,409,716 )     —         (1,409,716 )
                                                                                 

Balance at May 31, 2002

  34,186     5,063,550   15,643     1,542,372   —       —     —       —     18,908     2,631,429     (44,508 )     (3,749,288 )     26,575       406,580  

The accompanying notes are an integral part of these consolidated financial statements.

 

F-5


Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders' (Deficit) Equity (continued)

 

   

Series B

redeemable

convertible

preferred stock

   

Series A
convertible

preferred stock

   

Series B
convertible

preferred stock

 

Series C
convertible

preferred stock

  Common stock    

Additional

paid-in
capital

   

Accumulated

deficit

   

Other
comprehensive

income (loss)

 

Stockholders’

(deficit)
equity

 
    Shares   Amount     Shares   Amount     Shares   Amount   Shares   Amount   Shares   Amount          

Exercise of stock options

  —     —       —     —       —     —     —     —     1,292   11,138     —       —       —     11,138  

Issuance of Series B redeemable convertible preferred stock, net of issuance costs of $16,002

  34,186   5,265,223     —     —       —     —     —     —     —     —       —       —       —     —    

Accretion of dividends on Series B redeemable convertible preferred stock

  —     624,389     —     —       —     —     —     —     —     —       (624,389 )   —       —     (624,389 )

Stock-based compensation expense

  —     —       —     —       —     —     —     —     —     —       119,587     —       —     119,587  

Foreign currency translation adjustments

  —     —       —     —       —     —     —     —     —     —       —       —       857,466   857,466  

Net loss

  —     —       —     —       —     —     —     —     —     —       —       (2,994,967 )   —     (2,994,967 )
                                                                   

Balance at May 31, 2003 (Restated)(Note 2)

  68,372   10,953,162     15,643   1,542,372     —     —     —     —     20,200   2,642,567     (549,310 )   (6,744,255 )   884,041   (2,224,585 )

Exercise of stock options

  —     —       —     —       —     —     —     —     13   566     —       —       —     566  

Accretion of dividends on Series B redeemable convertible preferred stock

  —     1,111,059     —     —       —     —     —     —     —     —       (1,111,059 )   —       —     (1,111,059 )

Stock-based compensation expense

  —     —       —     —       —     —     —     —     —     —       315,407     —       —     315,407  

Foreign currency translation adjustments

  —     —       —     —       —     —     —     —     —     —       —       —       130,901   130,901  

Net loss

  —     —       —     —       —     —     —     —     —     —       —       (5,844,170 )   —     (5,844,170 )
                                                                   

Balance at May 31, 2004 (Restated)(Note 2)

  68,372   12,064,221     15,643   1,542,372     —     —     —     —     20,213   2,643,133     (1,344,962 )   (12,588,425 )   1,014,942   (8,732,940 )

Exercise of stock options

  —     —       —     —       —     —     —     —     17   794     —       —       —     794  

Accretion of dividends on Series B redeemable convertible preferred stock

  —     907,459     —     —       —     —     —     —     —     —       (907,459 )   —       —     (907,459 )

Stock-based compensation expense

  —     —       —     —       —     —     —     —     —     —       346,682     —       —     346,682  

Foreign currency translation adjustments

  —     —       —     —       —     —     —     —     —     —       —       —       263,927   263,927  

Net loss

  —     —       —     —       —     —     —     —     —     —       —       (5,265,157 )   —     (5,265,157 )
                                                                   

Balance at May 31, 2005 (Restated)(Note 2)

  68,372   12,971,680     15,643   1,542,372     —     —     —     —     20,230   2,643,927     (1,905,739 )   (17,853,582 )   1,278,869   (14,294,153 )

Issuance of warrants in connection with convertible notes and beneficial conversion features

  —     —       —     —       —     —     —     —     —     —       11,518,811     —       —     11,518,811  

Exercise of warrant to purchase Series B redeemable convertible preferred stock

  46,797   67,576     —     —       —     —     —     —     —     —       —       —       —     —    

Par value adjustment related to reorganization

  —     —       —     —       —     —     —     —     —     (2,643,925 )   2,643,925     —       —     —    

Stock issuance costs related to reorganization

  —     (367,856 )   —     (84,164 )   —     —     —     —     —     —       (108,880 )   —       —     (193,044 )

The accompanying notes are an integral part of these consolidated financial statements.

 

F-6


Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders' (Deficit) Equity (continued)

 

   

Series B

redeemable

convertible

preferred stock

   

Series A

convertible

preferred stock

   

Series B convertible

preferred stock

   

Series C convertible

preferred stock

    Common stock  

Additional

paid-in
capital

   

Accumulated

deficit

   

Other
comprehensive

income (loss)

   

Stockholders’

(deficit)
equity

 
    Shares     Amount     Shares     Amount     Shares     Amount     Shares     Amount     Shares   Amount        

Accretion of dividends on Series B redeemable convertible preferred stock

  —         422,421     —         —       —         —       —         —       —       —       (422,421 )     —         —         (422,421 )

Stock-based compensation expense

  —         —       —         —       —         —       —         —       —       —       199,038       —         —         199,038  

Foreign currency translation adjustments

  —         —       —         —       —         —       —         —       —       —       —         —         (166,910 )     (166,910 )

Net loss

  —         —       —         —       —         —       —         —       —       —       —         (15,588,885 )     —         (15,588,885 )
                                                                                                 

Balance at December 31, 2005 (Restated)(Note 2)

  115,169       13,093,821     15,643       1,458,208     —         —       —         —       20,230     2     11,924,734       (33,442,467 )     1,111,959       (18,947,564 )

Accretion of dividends on Series B redeemable convertible preferred stock

  —         1,879,727     —         —       —         —       —         —       —       —       (1,879,727 )     —         —         (1,879,727 )

Beneficial conversion feature in connection with convertible debentures

  —         —       —         —       —         —       —         —       —       —       8,724,752       —         —         8,724,752  

Stock-based compensation expense

  —         —       —         —       —         —       —         —       —       —       347,525       —         —         347,525  

Foreign currency translation adjustments

  —         —       —         —       —         —       —         —       —       —       —         —         406,955       406,955  

Net loss

  —         —       —         —       —         —       —         —       —       —       —         (30,141,159 )     —         (30,141,159 )
                                                                                                 

Balance at December 31, 2006 (Restated)(Note 2)

  115,169       14,973,548     15,643       1,458,208     —         —       —         —       20,230     2     19,117,284       (63,583,626 )     1,518,914       (41,489,218 )

Issuance of Series C convertible preferred stock and warrants for the purchase of Series C-1 convertible preferred stock and common stock and beneficial conversion features, net of issuance costs of $324,193 (unaudited)

  —         —       —         —       —         —       9,776,162       97,420,929     —       —       2,762,335       —         —         100,183,264  

Reversal of unamortized beneficial conversion features in connection with conversion of convertible debentures (unaudited)

  —         —       —         —       —         —       —         —       —       —       (7,025,664 )     —         —         (7,025,664 )

Accretion of dividends on Series B redeemable convertible preferred stock (unaudited)

  —         224,921     —         —       —         —       —         —       —       —       (224,921 )     —         —         (224,921 )

Issuance of Series B redeemable convertible preferred stock as stock dividend (unaudited)

  28,691       —       —         —       —         —       —         —       —       —       —         —         —         —    

Reclassification of Series B redeemable convertible preferred stock to Series B convertible preferred stock (unaudited)

  (143,860 )     (15,198,469 )   —         —       143,860       15,198,469     —         —       —       —       —         —         —         15,198,469  

Stock-based compensation expense (unaudited)

  —         —       —         —       —         —       —         —       —       —       19,511       —         —         19,511  

Net loss (unaudited)

  —         —       —         —       —         —       —         —       —       —       —         (18,718,715 )     —         (18,718,715 )
                                                                                                 

Balance at March 31, 2007 (unaudited)

  —       $ —       15,643     $ 1,458,208     143,860     $ 15,198,469     9,776,162     $ 97,420,929     20,230   $ 2   $ 14,648,545     $ (82,302,341 )   $ 1,518,914     $ 47,942,726  
                                                                                                 

Conversion of convertible preferred stock into common stock (unaudited)

  —         —       (15,643 )     (1,458,208 )   (143,860 )     (15,198,469 )   (9,776,162 )     (97,420,929 )   11,437,520     1,144     114,076,462       —         —         —    
                                                                                                 

Pro forma, March 31, 2007 (unaudited)

  —       $ —       —       $ —       —       $ —       —       $ —       11,457,750   $ 1,146   $ 128,725,007     $ (82,302,341 )   $ 1,518,914     $ 47,942,726  
                                                                                                 

The accompanying notes are an integral part of these consolidated financial statements.

 

F-7


Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Consolidated Statements of Cash Flows

 

   

Year Ended

May 31,

2004

   

Year Ended

May 31,

2005

   

Seven
Months
Ended

December 31,

2005

   

Year Ended

December 31,

2006

    Three Months Ended
March 31,
   

For the
Period from
May 20, 1997
(date of
inception)
through
March 31,

2007

 
            2006     2007    
    Restated
(Note 2 )
    Restated
(Note 2 )
    Restated
(Note 2 )
    Restated
(Note 2 )
    (unaudited)     (unaudited)  

Cash flows from operating activities:

             

Net loss

  $ (5,844,170 )   $ (5,265,157 )   $ (15,588,885 )   $ (30,141,159 )   $ (6,992,727 )   $ (18,718,715 )   $ (82,302,341 )

Adjustments to reconcile net loss to net cash used in operating activities:

             

Depreciation and amortization

    388,449       469,311       296,594       474,326       118,221       95,774       2,436,613  

Stock-based compensation expense

    315,407       346,682       199,038       347,525       83,436       19,512       1,460,544  

Gain on disposal of property and equipment

    —         —         —         —         —         —         (47,011 )

Amortization of deferred financing costs

    —         —         6,028       326,002       89,686       338,233       670,263  

Acquired in-process research and development

    —         —         10,847,582       —         —         7,500,000       18,347,582  

Non-cash interest expense

    —         186,379       840,347       14,640,192       4,138,243       1,691,465       17,358,383  

Unrealized foreign exchange loss (gain)

    (3,289 )     (131,297 )     (57,815 )     277,257       23,112       248,777       (13,833 )

Changes in operating assets and liabilities:

             

Investment tax credits recoverable

    (767,107 )     833,801       (1,014,803 )     1,336,252       676,660       (72,678 )     (716,193 )

Prepaid expenses and other current assets

    73,847       (14,274 )     (238 )     (170,884 )     (84,470 )     (1,061,295 )     (1,357,888 )

Deposits

    —         —         (13,880 )     (33,242 )     —         —         (47,122 )

Accounts payable

    42,916       2,536       186,529       883,155       (100,502 )     (458,463 )     1,130,175  

Accrued expenses

    (79,643 )     (202,491 )     966,993       (1,779,988 )     (982,747 )     318,501       (776,628 )

Income tax payable

    —         —         —         —         —         2,336,457       2,336,457  

Deferred rent

    10,652       8,182       3,203       3,383       846       527       38,867  

Deferred income tax

    740,706       604,972       (475,853 )     815,164       203,791       (2,212,530 )     (222,094 )
                                                       

Net cash used in operating activities

    (5,122,232 )     (3,161,356 )     (3,805,160 )     (13,022,017 )     (2,826,451 )     (9,974,435 )     (41,704,226 )
                                                       

Cash flows from investing activities:

             

Purchases of property and equipment

    (603,093 )     (127,732 )     (6,573 )     (181,468 )     (64,928 )     (110,421 )     (1,889,998 )

Proceeds from sale of property and equipment

    —         —         —         —         —         —         104,810  

Proceeds from maturities of short-term investments

    6,258,870       396,825       418,410       440,917       440,917       426,737       8,232,037  

Purchases of short-term investments

    (372,356 )     (396,825 )     (418,410 )     (440,917 )     (440,917 )     (426,737 )     (7,850,746 )
                                                       

Net cash (used in) provided by investing activities

    5,283,421       (127,732 )     (6,573 )     (181,468 )     (64,928 )     (110,421 )     (1,403,897 )
                                                       

 

F-8


Table of Contents
   

Year Ended

May 31,

2004

   

Year Ended

May 31,

2005

   

Seven
Months
Ended

December 31,

2005

   

Year Ended

December 31,

2006

    Three Months Ended
March 31,
   

For the
Period from
May 20, 1997
(date of
inception)
through
March 31,

2007

 
            2006     2007    
    Restated
(Note 2)
    Restated
(Note 2)
    Restated
(Note 2)
    Restated
(Note 2)
    (unaudited)     (unaudited)  

Cash flows from financing activities:

             

Proceeds from bank loan

    —         —         —         —         —         —         327,401  

Payments on bank loan

    —         —         —         —         —         —         (336,723 )

Proceeds from issuance of note payable

    —         4,126,984       2,343,096       —         —         —         6,470,080  

Payments on note payable

    (59,577 )     —         (20,921 )     —         —         —         (80,498 )

Principal payments under capital leases

    (317,711 )     (328,611 )     (130,402 )     (83,150 )     (39,138 )     —         (1,273,489 )

Proceeds from issuance of convertible notes

    —         —         11,762,628       —         —         —         11,762,628  

Payments on convertible notes

    —         —         —         —         —         (2,176,850 )     (2,176,850 )

Proceeds from issuance of convertible debentures

    —         —         —         14,028,000       —         —         14,028,000  

Proceeds (costs) from issuance of preferred stock and warrants, net of issuance costs

    —         —         (384,444 )     —         —         57,824,663       69,154,063  

Proceeds (costs) from issuance of common stock, net of issuance costs

    566       794       (108,880 )     —         —         —         2,535,047  

Deferred financing costs

    —         —         (278,463 )     (420,148 )     —         (82,456 )     (781,067 )
                                                       

Net cash provided by (used in) financing activities

    (376,722 )     3,799,167       13,182,614       13,524,702       (39,138 )     55,565,357       99,628,592  
                                                       

Net increase (decrease) in cash and cash equivalents

    (215,533 )     510,079       9,370,881       321,217       (2,930,517 )     45,480,501       56,520,469  

Effect of foreign currency on cash and cash equivalents

    15,181       261,717       237,725       1,894       (5,184 )     15,212       1,078,946  
                                                       

Cash and cash equivalents, beginning of period

    1,600,541       1,400,189       2,171,985       11,780,591       11,780,591       12,103,702       —    
                                                       

Cash and cash equivalents, end of period

  $ 1,400,189     $ 2,171,985     $ 11,780,591     $ 12,103,702     $ 8,844,890     $ 57,599,415     $ 57,599,415  
                                                       

Supplemental disclosure of cash flow information

             

Cash paid during the period for interest

  $ 41,418     $ 24,626     $ 5,264     $ 1,227     $ 1,227     $ 179,861     $ 360,551  

Supplemental disclosure of non-cash financing activities

             

Discount to note payable for warrant valuation

  $ —       $ 444,444     $ 235,168     $ —       $ —       $ —       $ 679,612  

Issuance of InterMune convertible note

  $ —       $ —       $ 8,847,582     $ —       $ —       $ 7,500,000     $ 16,347,582  

Reduction of InterMune convertible note

  $ —       $ —       $ —       $ —       $ —       $ (3,000,000 )   $ (3,000,000 )

Discount to convertible notes for warrant valuation and beneficial conversion features

  $ —       $ —       $ 11,518,811     $ —       $ —       $ —       $ 11,518,811  

Discount to convertible debentures for beneficial conversion features

  $ —       $ —       $ —       $ 8,724,752     $ —       $ —       $ 8,724,752  

Conversion of convertible debt into preferred stock

  $ —       $ —       $ —       $ —       $ —       $ (38,989,659 )   $ (38,989,659 )

Reversal of beneficial conversion features in connection with conversion of convertible debentures

  $ —       $ —       $ —       $ —       $ —       $ (7,025,664 )   $ (7,025,664 )

Accretion of redeemable convertible preferred stock to redemption value

  $ 1,111,059     $ 907,459     $ 422,421     $ 1,879,727     $ 469,932     $ 224,921     $ 5,327,277  

The accompanying notes are an integral part of these consolidated financial statements.

 

F-9


Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements

(Including data applicable to unaudited periods)

1. Nature of business

Targanta Therapeutics Corporation, a Delaware corporation, was incorporated on December 6, 2005 to become the parent entity of Targanta Therapeutics Inc. (“ Targanta Québec ”) (previously PhageTech Inc.) and Targanta Therapeutics (Ontario) Inc. (“ Targanta Ontario ”) as part of a reorganization that was effective December 23, 2005. Targanta Québec, a Canadian company, was incorporated on May 20, 1997 and Targanta Ontario, a Canadian company, was incorporated on December 22, 2005. Targanta Therapeutics Corporation together with its subsidiaries (the “ Company ”) is a biopharmaceutical company focused on developing and commercializing antibacterial drugs to treat serious infections in the hospital setting. The Company’s pipeline includes an array of antibacterial agents in various stages of development. Oritavancin, the Company’s lead product candidate, is a once-daily, semi-synthetic glycopeptide antibiotic with rapid bactericidal activity against all studied clinically relevant serious gram-positive pathogens, including multi-resistant strains. The Company has commenced its planned principal operations; however, the Company has not generated any revenue from its operations. Accordingly, the Company is considered to be in the development stage as defined in Statement of Financial Accounting Standards (“ SFAS ”) No. 7, Accounting and Reporting by Development Stage Enterprises . The Company’s activities are carried out at its facilities in Cambridge, Massachusetts, Indianapolis, Indiana, and Montreal, Québec, Canada and its location in Toronto, Ontario, Canada.

The Company is subject to a number of risks similar to other biopharmaceutical companies in the development stage, including but not limited to raising additional capital, development by its competitors of new technological innovations, dependence on key personnel, compliance with government regulations, market acceptance of the Company’s products, and protection of proprietary technology. If it does not successfully commercialize any of its product candidates, it will be unable to generate product revenue or achieve profitability. To date, the Company has financed its cash requirements primarily through issuances of equity and debt securities, loan facilities, investment tax credits, capital leases and interest income. As of December 31, 2006 and March 31, 2007, the Company had a deficit accumulated during the development stage of $63.6 million and $82.3 million, respectively. It expects to continue to incur operating losses over the next several years and it may never be profitable.

Reorganization

On December 23, 2005, the Company effected a reorganization of the beneficial ownership structure of Targanta Québec. Pursuant to this reorganization the following changes were made:

 

  i.   The Common Shares of Targanta Québec were exchanged on a one-for-one basis into Common Exchangeable Shares of Targanta Québec and each holder of such Common Exchangeable Shares was issued the same number of shares of Common Special Voting Stock of the Company.

 

  ii.   The Class A-l Preferred Shares of Targanta Québec were exchanged on a one-for-one basis into Class A Preferred Exchangeable Shares of Targanta Québec and each holder of such Class A Preferred Exchangeable Shares was issued the same number of shares of Series A Special Voting Stock of the Company.

 

  iii.   The Class A-2 Preferred Shares of Targanta Québec were exchanged on a one-for-one basis into Class B Preferred Exchangeable Shares of Targanta Québec and each holder of such Class B Preferred Exchangeable Shares was issued the same number of shares of Series B Special Voting Stock of the Company.

 

  iv.   A new class of shares was created and designated New Common Shares and these shares were issued to the Company to reflect its ownership of Targanta Québec.

 

F-10


Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

1. Nature of business (continued)

 

The Company accounted for the reorganization in accordance with Emerging Issues Task Force (“ EITF ”) Issue No. 90-5, Exchanges of Ownership Interests between Entities under Common Control (“ EITF 90-5 ”). As the transaction was an exchange of stock between companies under common control, and the only assets of the combined entity after the exchange were those of the subsidiary prior to the exchange, a change in ownership did not take place and the exchange was accounted for based on the carrying amounts of the subsidiary’s assets and liabilities.

Targanta Ontario

At the same time as the reorganization, the Company formed Targanta Ontario. As of March 31, 2007, the capital structure of Targanta Ontario consists of Common Shares (which are held entirely by the Company), Common Exchangeable Shares, Class B Preferred Exchangeable Shares and Class C Preferred Exchangeable Shares.

Exchangeable Shares

The Common Exchangeable Shares, Class A Preferred Exchangeable Shares, Class B Preferred Exchangeable Shares and Class C Preferred Exchangeable Shares of Targanta Québec and Targanta Ontario (collectively, the “ Exchangeable Shares ”) exist to facilitate the investment of capital by certain venture capital corporations who may only invest in Canadian incorporated companies or the tax concerns of certain other Canadian resident investors. The Exchangeable Shares are securities of the Company’s wholly-owned subsidiaries (on an as-if exchanged basis), Targanta Québec and Targanta Ontario, which securities entitle the holders to dividends and other rights economically equivalent to those of the Company’s Common Stock, Series A Convertible Preferred Stock, Series B Convertible Preferred Stock (previously classified as the Series B Redeemable Convertible Preferred Stock) and Series C Convertible Preferred Stock (collectively, the “ Convertible Preferred Stock ”). The Exchangeable Shares can be exchanged at the option of their holders on the occurrence of certain events and shall automatically be exchanged upon the liquidation of the Company (including a qualified public offering) for the corresponding shares of the Company’s Series A Convertible Preferred Stock, Series B Convertible Preferred Stock, Series C Convertible Preferred Stock and Common Stock on a share-for-share basis (subject to adjustment).

Special voting stock

The Company has also authorized and outstanding shares of Common Special Voting Stock, Series A Special Voting Stock, Series B Special Voting Stock and Series C Special Voting Stock (collectively, the “ Special Voting Stock ”). The Special Voting Stock exists for the benefit of the holders of Exchangeable Shares and each holder of an Exchangeable Share receives a share of the like class or series of Special Voting Stock. By holding shares of Special Voting Stock, the holders of Exchangeable Shares are entitled to voting rights in the Company (whether at stockholder meetings or in actions taken by written consent of the Company’s stockholders). The Special Voting Stock does not participate in any liquidation event of the Company, is not convertible and is not entitled to receive dividends or any other economic rights.

If the number or class of Exchangeable Shares held by a holder changes, a like change shall be made to the shares of Special Voting Stock held by such holder. Therefore, if a holder of Class A Preferred Exchangeable Shares, Class B Preferred Exchangeable Shares or Class C Preferred Exchangeable Shares of either Targanta Québec or Targanta Ontario converts such shares into Common Exchangeable Shares of such issuer, the corresponding shares of Series A Special Voting Stock, Series B Special Voting Stock or Series C Special Voting Stock held by such holder shall automatically be converted into shares of Common Special Voting Stock.

 

F-11


Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

1. Nature of business (continued)

 

In the accompanying consolidated financial statements, all share amounts are presented on an as-if exchanged basis. The Exchangeable Shares issued by Targanta Québec and Targanta Ontario and the Special Voting Stock are treated as if the Exchangeable Shares were exchanged for shares of the corresponding class or series of capital stock of the Company and the Special Voting Stock had been consolidated into the corresponding class or series of shares of the Company. By way of example, the outstanding Class A Preferred Exchangeable Shares of Targanta Québec and related shares of Series A Special Voting Stock of the Company are shown as outstanding shares of Series A Convertible Preferred Stock. On an as-if exchanged basis, Targanta Québec and Targanta Ontario are treated as wholly-owned subsidiaries.

2. Restatement and summary of significant accounting policies

A. Restatement

The Company is restating its consolidated financial statements as of December 31, 2005 and 2006 and for the years ended May 31, 2004 and 2005, the seven months ended December 31, 2005, the year ended December 31, 2006 and the period from May 20, 1997 (date of inception) through December 31, 2006 included in the Company’s initial Registration Statement on Form S-1 due to the discovery of errors in accounting for the Canadian Part VI.I tax requirement. The following provides a more detailed discussion of the restatement along with a comparison of the amounts previously reported.

As discussed in Note 12 and Note 15, the Company has accrued the potential Canadian Part VI.I tax related to the cumulative dividend on the Series B Redeemable Convertible Preferred Stock. The Company accrued the Part VI.I tax as a reduction of additional paid-in capital with the dividend on the Series B Redeemable Convertible Preferred Stock in the Company’s initial Registration Statement on Form S-1. Subsequent to the filing of such Registration Statement, the Company concluded that it had erroneously calculated the amount of the Part VI.I tax liability in prior periods and had inappropriately recorded the Part VI.I tax liability in additional paid-in capital, rather than as an income tax expense. The errors in the calculation of the amount of the liability were a result of the Company accruing the Part VI.I tax on all dividends, including dividends that would be paid by Targanta Therapeutics Corporation to certain holders of Series B Redeemable Convertible Preferred Stock which are not subject to the tax. The error in the classification of the accrual for the Part VI.I tax was a result of the Company not applying the provisions of Emerging Issues Task Force Issue No. 95-9, Accounting for Tax Effects of Dividends in France in Accordance with FASB Statement No. 109 , in accounting for the Canadian Part VI.I tax, which states that unless specific criteria are met, taxes on distributions should be treated as an income tax expense.

As a result of the restatement, the Company has made adjustments to present the corrected amount of the Part VI.I tax liability as a charge to income tax expense in the statements of operations and as (1) a long-term deferred tax liability in the December 31, 2005 consolidated balance sheet, and (2) a current deferred tax liability in the December 31, 2006 consolidated balance sheet since the January 2007 dividend payment was both planned and probable at that time. The Part VI.I tax liability is presented as a current tax liability in the March 31, 2007 consolidated balance sheet.

Set forth below are the adjustments to the Company’s previously issued statements of operations and balance sheets for the periods affected by the restatement. The restatement adjustments did not affect the net cash used in operating activities in the Company’s statements of cash flows.

 

F-12


Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

2. Restatement and summary of significant accounting policies (continued)

 

Impact of the Financial Statement Adjustments on the Consolidated Balance Sheets and Statements of Operations

 

     Year Ended
May 31, 2004
    Year Ended
May 31, 2005
    Seven Months
Ended
December 31,
2005
    Year Ended
December 31,
2006
   

For the Period
from May 20,
1997 (date of
inception)

through
December 31,
2006

 
          

Statements of operations

          

As previously reported:

          

Income tax benefit

   $ 1,516,873     $ 1,363,724     $ 1,014,803     $ 384,480     $ 7,592,497  

Net loss

   $ (5,103,464 )   $ (4,660,184 )   $ (16,064,738 )   $ (29,325,995 )   $ (61,593,189 )

Net loss per share

   $ (344.16 )   $ (305.33 )   $ (828.72 )   $ (1,596.18 )   $ —    

As restated:

          

Income tax (expense) benefit

   $ 776,167     $ 758,752     $ 1,490,656     $ (430,684 )   $ 5,602,061  

Net loss

   $ (5,844,170 )   $ (5,265,157 )   $ (15,588,885 )   $ (30,141,159 )   $ (63,583,626 )

Net loss per share

   $ (344.16 )   $ (305.33 )   $ (791.46 )   $ (1,582.84 )   $ —    

 

    As of December 31,  
  2005     2006  

Balance sheets

   

As previously reported:

   

Series B Redeemable Convertible Preferred Stock

  $ 15,022,875     $ 17,987,642  

Deferred income tax

  $ —       $ —    

Long - term deferred income tax

  $ —       $ —    

Additional paid-in capital

  $ 9,995,680     $ 16,103,190  

Accumulated other comprehensive income

  $ 1,355,095     $ 1,741,007  

Deficit accumulated during the development stage

  $ (32,267,194 )   $ (61,593,189 )

As restated:

   

Series B Redeemable Convertible Preferred Stock

  $ 13,093,821     $ 14,973,548  

Deferred income tax

  $ —       $ 2,212,530  

Long - term deferred income tax

  $ 1,418,409     $ —    

Additional paid-in capital

  $ 11,924,734     $ 19,117,284  

Accumulated other comprehensive income

  $ 1,111,959     $ 1,518,914  

Deficit accumulated during the development stage

  $ (33,442,467 )   $ (63,583,626 )

B. Summary of significant accounting policies

Unaudited interim consolidated financial information

The accompanying interim consolidated balance sheet as of March 31, 2007, the consolidated statements of operations and cash flows for the three months ended March 31, 2006 and 2007, and the consolidated statements

 

F-13


Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

2. Restatement and summary of significant accounting policies (continued)

 

of redeemable convertible preferred stock and stockholders’ (deficit) equity for the three months ended March 31, 2007 including notes thereto are unaudited. The unaudited interim consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States. In the opinion of the Company’s management, the unaudited interim consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements and include all adjustments consisting of normal recurring accruals necessary for the fair presentation of the Company’s financial position as of March 31, 2007 and its results of operations and its cash flows for the three months ended March 31, 2006 and 2007 except for the adoption of FIN 48 as discussed below.

Unaudited pro forma presentation

The unaudited pro forma consolidated balance sheet and the unaudited pro forma consolidated statement of redeemable convertible preferred stock and stockholders’ (deficit) equity reflect the expected automatic conversion of the outstanding shares of Convertible Preferred Stock into 11,437,520 shares of Common Stock as though the completion of the initial public offering contemplated by the filing of this prospectus had occurred on March 31, 2007. Shares of Common Stock issued in the initial public offering and any related estimated net proceeds are excluded from such pro forma information. In addition, the Company has outstanding and exercisable warrants to purchase 6,837 shares of Series B Convertible Preferred Stock, 484,354 shares of Series C Convertible Preferred Stock and 29,855 shares of Common Stock. The warrants to purchase Series B Convertible Preferred Stock and Series C Convertible Preferred Stock will convert into warrants to purchase an equal number of shares of Common Stock.

The following unaudited pro forma consolidated statements of operations assume the conversion of all Convertible Preferred Stock, redeemable convertible preferred stock and convertible debt at January 1, 2006 and January 1, 2007 (or at the original date of issuance, if later), the exclusion of interest expense recorded during 2006 and the three months ended March 31, 2007 applicable to the convertible debt and the recognition as interest expense of the unamortized debt discount related to the beneficial conversion features and the unamortized deferred financing costs related to the convertible debt.

 

     Year Ended
December 31,
2006
Pro forma
   

Three Months Ended
March 31,

2007

Pro forma

 
     Restated        

Operating expenses

    

Research and development

   $ 11,455,780     $ 5,439,450  

Acquired in-process research and development

     —         9,500,000  

General and administrative

     3,352,635       1,934,559  
                

Total expenses

     14,808,415       16,874,009  
                

Other income (expense)

    

Interest income

     280,402       458,134  

Interest expense

     (21,551,773 )     (8,999,249 )

Foreign exchange loss

     (214,436 )     (64,418 )
                

Other income (expense), net

     (21,485,807 )     (8,605,533 )
                

Loss before income tax expense

     (36,294,222 )     (25,479,542 )

Income tax expense

     (430,684 )     (28,863 )
                

Net loss

   $ (36,724,906 )   $ (25,508,405 )
                

 

F-14


Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

2. Restatement and summary of significant accounting policies (continued)

 

Change in fiscal year

In December 2005, in conjunction with the reorganization, the Company assumed the fiscal year of Targanta Therapeutics Corporation which is the year ending on December 31. Prior to the reorganization, the Company followed the fiscal year of Targanta Québec which was the year ending May 31. These consolidated financial statements include the results of the Company’s operations and its cash flows for the years ended May 31, 2004 and 2005, the seven months ended December 31, 2005 (the “ Transition Period ”), the year ended December 31, 2006 and the three months ended March 31, 2006 and 2007.

Stock split

On January 31, 2007, the Company’s Board of Directors and stockholders authorized a 1:150 reverse stock split for all authorized and outstanding shares of Series A Convertible Preferred Stock, Series B Convertible Preferred Stock and Common Stock. Consequently, all share information has been retroactively restated to reflect the reverse stock split.

Principles of consolidation

The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries Targanta Québec and Targanta Ontario (on an as-if exchanged basis). All significant intercompany accounts and transactions have been eliminated.

Use of estimates

The preparation of the Company’s consolidated financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from such estimates. Changes in estimates are recorded in the period in which they become known.

The Company also utilizes significant estimates and assumptions in determining the fair value of its Common Stock. The Company has historically granted stock options at exercise prices not less than the fair market value of its Common Stock as determined by the Board of Directors, with input from management. The Board of Directors has historically determined the estimated fair market value of the Company’s Common Stock on the date of grant based on a number of objective and subjective factors, including external market conditions affecting the biotechnology industry sector and the prices at which the Company sold shares of Convertible Preferred Stock, the superior rights and preferences of securities senior to the Company’s Common Stock at the time of each grant and, the likelihood of achieving a liquidity event such as an initial public offering or sale of the Company.

The following table presents the grant dates and related exercise prices of stock options granted to employees in 2006:

 

     Number of options
granted
   Exercise
price

March 29, 2006

   11,079    $ 36.00

March 29, 2006

   500    $ 48.63

July 13, 2006

   4,263    $ 36.00

October 17, 2006

   13,832    $ 70.50

November 10, 2006

   3,055    $ 70.50
       

Total

   32,729   
       

 

F-15


Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

2. Restatement and summary of significant accounting policies (continued)

 

The Company did not grant any stock options in the three months ended March 31, 2007.

At the time of each of these stock option grants, the Board of Directors, with input from management, established the applicable exercise price based on the various objective and subjective factors noted above.

In connection with the preparation of the consolidated financial statements for the year ended December 31, 2006 and in preparing for an initial public offering (“ IPO ”), the Company performed retrospective valuations of its Common Stock as of January 1, 2006 and September 30, 2006. The valuation methodologies used in the retrospective valuations are consistent with the American Institute of Certified Public Accountant’s Technical Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation (“ Practice Aid ”). The Company believes that the preparation of the retrospective valuations was necessary due to the fact that the timeframe for a potential IPO had accelerated significantly since the time the Company’s Board of Directors set the exercise prices for these option grants.

In each of the retrospective valuations, the Company used the Market Approach to estimate the aggregate future enterprise value of the Company under an IPO scenario, sale scenario and dissolution scenario. In applying the Market Approach in the IPO scenario, the Company used the Guideline Public Company Method as described in the Practice Aid. Under this method, the Company identified seven comparable publicly-traded biotechnology companies (the “ Guideline Companies ”) that either (1) are focused on the development of antiinfectives, (2) currently have one primary marketed product, or (3) are currently developing a product in Phase 3 clinical trials. The Company used the average of the Guideline Companies’ trailing twelve-month revenues to estimate twelve additional months of revenue and the enterprise values of the companies as of the valuation dates, and then computed the enterprise value-to-revenue multiples for each Guideline Company. The Company then applied the average enterprise value-to-revenue multiple to its estimated 2008 revenues (its estimate of the date of its first commercial revenues) to estimate the future enterprise value of the Company. The Company used this value as the enterprise value in the IPO scenario of the Probability Weighted Expected Return Method.

In applying the Market Approach in the sale scenario, the Company analyzed sale transactions of similar biotechnology companies. The value used was supported by published transaction values of companies with product candidates in similar stages of development as the Company estimates its product candidate, oritavancin, would be at December 2007, the estimated date a sale or merger would be consummated.

In applying the Market Approach in the dissolution scenario, the Company assumed a sale of its existing research and intellectual property at a value that would not allow the preferred stockholders to realize their liquidation preference.

In order to allocate the enterprise values to the Common Stock, the Company used the Probability Weighted Expected Return Method described in the Practice Aid. Under this method, the value of the Company’s Common Stock is estimated based upon an analysis of future values for the Company assuming various future outcomes, the timing of which is based on the plans of the Board of Directors and management. Under this approach, share value is based on the probability-weighted present value of expected future investment returns, considering each of the possible outcomes available to the Company, as well as the rights of each share class. The Company estimated the fair market value of the Company’s Common Stock using a probability-weighted analysis of the present value of the returns afforded to the Company’s shareholders under each of three possible future scenarios. Two of the scenarios assumed a shareholder exit, either through an IPO or a sale of the Company. The third scenario assumed a liquidation or dissolution of the Company at a value that is less than the cumulative

 

F-16


Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

2. Restatement and summary of significant accounting policies (continued)

 

amounts invested by the Company’s preferred shareholders. For the IPO and sale scenarios, the estimated future and present values of the Company’s Common Stock were calculated using assumptions including: the expected pre-money or sale valuations based on the Market Approach (as discussed above), the expected dates of the future expected IPO or sale, and an appropriate risk-adjusted discount rate. For the dissolution or liquidation scenario, the estimated future and present values of the Company’s Common Stock were calculated using assumptions including: the aggregate enterprise value that could be attained through such a sale (as discussed above), the expected date of the future dissolution and an appropriate risk-adjusted discount rate. Finally, the present value calculated for the Company’s Common Stock under each scenario was probability weighted based on the Company’s estimate of the relative occurrence of each scenario.

In the retrospective valuations for January and September 2006, the Company’s assumptions for the three potential future outcomes were as follows: (i) the Company becomes a public company in May 2007 (“ IPO Scenario ”), (ii) the Company is acquired in December 2007 for a premium (“ Sale Scenario ”), and (iii) the Company is acquired in December 2007 for less than the liquidation value of preferred stock (“ Dissolution Scenario ”).

The Company used a 35% probability weight for the IPO Scenario in its January 2006 retrospective valuation and increased this percentage to 40% in the September 2006 retrospective valuation as the Company achieved significant business milestones, as coverage of the Company increased, as the Company progressed in its meetings with the United States Food and Drug Administration (“ FDA ”) in 2006 and as discussions with institutional investors increased in late 2006.

This increase in the probability weight assigned to the IPO Scenario caused the value ascribed to the Company’s Common Stock to increase. Under the IPO Scenario, the fair value of Common Stock was calculated using the expected aggregate enterprise valuations and a risk-adjusted discount rate of 16% based on the estimated timing of a potential initial public offering with no lack of marketability discount. The risk-adjusted discount rate was based on the inherent risk of a hypothetical investment in the Company’s Common Stock. An appropriate rate of return required by a hypothetical investor was determined based on the Company’s calculated cost of capital. The Company’s calculated cost of capital was developed based upon a quantitative and qualitative analysis of factors that would impact the discount rate.

The fair value of the Company’s Common Stock under the Sale Scenario was determined by reducing the total estimated enterprise value by the liquidation preferences of those preferred shares that would receive more value based on their liquidation preference as opposed to converting to Common Stock and in the Dissolution Scenario was determined by reducing the total estimated enterprise value by the liquidation preferences of the Series A Convertible Preferred Stock and the Series B Redeemable Convertible Preferred Stock. In both scenarios, the total estimated enterprise value was reduced by the repayment of the outstanding debt.

The estimated fair market value of the Company’s Common Stock at each valuation date is equal to the sum of the probability weighted present values for each scenario. The Company incorporated the fair values calculated in the retrospective valuations into the Black-Scholes option pricing model when calculating the stock-based compensation expense to be recognized for the stock options granted. The retrospective valuations generated per share fair values of the Company’s Common Stock of $4.53 and $5.76 for January and September 2006, respectively. Since the exercise prices of the Company’s stock options were in excess of the fair value of its Common Stock derived from the retrospective valuations, there was no intrinsic value at either valuation date.

 

F-17


Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

2. Restatement and summary of significant accounting policies (continued)

 

Cash and cash equivalents

The Company considers all short-term, highly liquid investments with original maturities of three months or less at acquisition date to be cash equivalents. At December 31, 2005 and 2006 and March 31, 2007, the Company’s cash equivalents include amounts held in certificates of deposit and an overnight investment account.

Short-term investments

The Company accounts for its investments in accordance with SFAS No. 115, Accounting for Certain Investments in Debt and Equity Securities (“ SFAS No. 115 ”). In accordance with SFAS No. 115, the Company has classified all of its investments as available-for-sale at December 31, 2005 and 2006 and March 31, 2007. The investments are reported at fair value, with any unrealized gains or losses reported as a separate component of stockholders’ (deficit) equity as accumulated other comprehensive income (loss).

Concentration of credit risk

The Company maintains its cash and cash equivalents and short-term investments with high quality financial institutions, and accordingly, are subject to minimal credit risk. Short-term investments, which consist of a single guaranteed investment certificate, are invested in a Canadian financial institution. Investment tax credits recoverable were due from the Canadian Federal and Québec provincial governments. The Company does not maintain foreign exchange contracts or other off-balance sheet financial instruments.

Fair value of financial instruments

Cash and cash equivalents, investments, receivables, accounts payable, accrued expenses and short-term convertible debt are carried at amounts that approximate fair value at December 31, 2005 and 2006 and March 31, 2007 due to their short-term maturities.

The long-term convertible debt approximates fair value at December 31, 2005 and 2006 as it is calculated using a discounted cash flow model with an incremental borrowing rate.

Property and equipment

Property and equipment, including leasehold improvements, are recorded at cost and depreciated over their estimated useful lives using the straight-line method. Assets held under capitalized leases are stated at the present value of future minimum lease obligations. Leasehold improvements are amortized over the shorter of their useful lives or the terms of the related lease.

Repair and maintenance expenditures are charged to expense as incurred. Expenditures for major renewals and betterments, which significantly extend the useful lives of existing equipment, are capitalized and depreciated. When equipment is retired or otherwise disposed of, the cost of such equipment and the related accumulated depreciation are removed from the accounts. Any resulting gain or loss is included in the determination of net loss.

 

F-18


Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

2. Restatement and summary of significant accounting policies (continued)

 

Impairment of long-lived assets

The Company evaluates the recoverability of its long-lived assets when circumstances indicate that an event of impairment may have occurred in accordance with the provisions of SFAS No. 144, Accounting for the Impairment of Disposal of Long-Lived Assets (“ SFAS No. 144 ”) . SFAS No. 144 further refines the requirements of SFAS No. 121, Accounting for the Impairment of Long-Lived Assets and Long-Lived Assets to be Disposed of, that companies (1) recognize an impairment loss only if the carrying amount of a long-lived asset is not recoverable based on its undiscounted future cash flows, and (2) measure an impairment loss as the difference between the carrying amount and fair value of the asset. The Company has concluded that none of its long-lived assets were impaired at each balance sheet date.

Research and development costs

The Company charges research and development costs to operations as incurred in accordance with SFAS No. 2, Accounting for Research and Development Costs . Research and development costs are comprised of costs incurred in performing research and development activities, including salaries, benefits, facilities, research-related overhead, contracted services, license fees, and other external costs. Acquired in-process research and development having no alternative future use is written off at the time of acquisition. The cost of intangibles that are purchased from others for a particular research and development project that have no alternative future use are written off at the time of acquisition.

Net loss per share

The Company calculates net loss per share in accordance with SFAS No. 128, Earnings Per Share . Basic and diluted net loss per common share was determined by dividing net loss by the weighted average common shares outstanding during the period. The Company’s potentially dilutive shares, which include convertible debt, Convertible Preferred Stock, outstanding Common Stock options and common and preferred stock warrants, have not been included in the computation of diluted net loss per share for all periods as the result would be anti-dilutive.

 

    

Year Ended
May 31,

2004

   

Year Ended
May 31,

2005

   

Seven Months
Ended
December 31,

2005

   

Year Ended
December 31,

2006

   

Three Months Ended
March 31,

 
            

2006

   

2007

 
    

Restated

   

Restated

   

Restated

   

Restated

   

(unaudited)

 

As reported:

            

Net loss

   $ (5,844,170 )   $ (5,265,157 )   $ (15,588,885 )   $ (30,141,159 )   $ (6,992,727 )   $ (18,718,715 )

Accretion of Series B Redeemable Convertible Preferred Stock dividends

     (1,111,059 )     (907,459 )     (422,421 )     (1,879,727 )     (469,932 )     (224,921 )
                                                

Net loss applicable to common stockholders

     (6,955,229 )     (6,172,616 )     (16,011,306 )     (32,020,886 )     (7,462,659 )     (18,943,636 )
                                                

Weighted-average number of common shares used in net loss per share—basic and diluted

     20,209       20,216       20,230       20,230       20,230       20,230  
                                                

Net loss per share applicable to common stockholders—basic and diluted

   $ (344.16 )   $ (305.33 )   $ (791.46 )   $ (1,582.84 )   $ (368.89 )   $ (936.41 )
                                                

 

F-19


Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

2. Restatement and summary of significant accounting policies (continued)

 

The following potentially dilutive securities have been excluded from the computation of diluted weighted average shares outstanding as of May 31, 2004 and 2005, December 31, 2005 and 2006 and March 31, 2006 and 2007 , as they would be anti-dilutive.

 

    

May 31,

2004

  

May 31,

2005

  

December 31,

2005

  

December 31,

2006

  

March 31,
2006

  

March 31,
2007

                        

(unaudited)

Convertible Preferred Stock

   93,502    98,051    146,965    156,387    149,321    9,935,665

Convertible debt

   —      —      59,338    178,675    60,492    —  

Warrants outstanding

   —      4,444    6,837    6,837    6,837    522,409

Options outstanding

   16,006    14,200    13,789    46,017    24,957    46,017

Unaudited pro forma net loss per share assuming the conversion of all Convertible Preferred Stock and convertible debt at the beginning of the period (or at the original date of issuance, if later) is as follows:

 

    

December 31,

2006

   

March 31,

2007

 
     Restated        

Unaudited:

    

Net loss, as reported:

   $ (30,141,159 )   $ (18,718,715 )

Interest expense on convertible debt

     (6,583,747 )     (6,789,690 )
                

Net loss applicable to common stockholders

     (36,724,906 )     (25,508,405 )
                

Weighted-average number of common shares outstanding

     20,230       20,230  

Weighted-average number of common shares assuming conversion of all Convertible Preferred Stock and convertible debt at the beginning of the period (or at the original date of issuance, if later)

     278,688       11,437,520  
                

Weighted-average common shares used in computing pro forma net loss per share

     298,918       11,457,750  
                

Pro forma net loss per share—basic and diluted

   $ (122.86 )   $ (2.23 )
                

Stock-based compensation

The Company adopted SFAS No. 123 (revised 2004), Share Based Payment (“ SFAS No. 123(R) ”), effective January 1, 2006. SFAS No. 123(R) requires the recognition of the fair value of stock-based compensation in the Company’s consolidated statements of operations. The Company elected the modified prospective transition method for adopting SFAS No. 123(R). Under this method, the provisions of SFAS No. 123(R) apply to all awards granted or modified after the date of adoption and results for prior periods have not been restated. As a result of the adoption of SFAS No. 123(R), the change in the Company’s net loss for the year ended December 31, 2006 was not material. Additionally, under the provisions of SFAS No. 123(R), the Company is required to include an estimate of the value of the awards that will be forfeited in calculating compensation costs, which is recognized over the requisite service period of the awards on a straight-line basis. Prior to the adoption of the fair value recognition provisions of SFAS No. 123(R), share-based payment expense was adjusted for actual forfeitures as they occurred. The cumulative effect of the change in accounting for forfeitures was not material to the consolidated financial statements.

From inception and prior to January 1, 2006, the Company accounted for employee stock-based compensation arrangements in accordance with the provisions of SFAS No. 123, Accounting for Stock-Based Compensation (“ SFAS No. 123 ”), which required that stock-based compensation cost be measured at the grant

 

F-20


Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

2. Restatement and summary of significant accounting policies (continued)

 

date based on the fair value of the award and be recognized as expense over the vesting period. The fair value of options to purchase common stock granted to employees (determined using the Black-Scholes option-pricing model) was being expensed over the vesting period of the related stock-based award. The options are exercisable over a ten-year period from the date of grant or such lesser period of time as the Board of Directors may approve. The options vest over a period of three to five years or such lesser period of time as the Board of Directors may approve.

Equity instruments issued to non-employees are recorded at their fair value as determined in accordance with SFAS No. 123(R) and EITF Issue No. 96-18, Accounting for Equity Instruments That are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling Goods and Services , and are periodically revalued as the equity instruments vest and are recognized as expense over the related service period.

Comprehensive income (loss)

The Company has applied SFAS No. 130, Reporting Comprehensive Income , which requires that all components of comprehensive income (loss) be reported in the consolidated financial statements in the period in which they are recognized. Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. Other than the Company’s net loss, the only other element of comprehensive income (loss) impacting the Company is cumulative foreign currency translation adjustments. Comprehensive income (loss) is reflected in the consolidated statements of redeemable convertible preferred stock and stockholders’ (deficit) equity.

Foreign currency translation

For the cumulative period ended December 31, 2006, the financial statements of Targanta Québec were measured using the local currency as the functional currency, with results of operations and cash flows translated at average exchange rates during the period, and assets and liabilities translated at end of period exchange rates. For Targanta Québec, translation adjustments were excluded from the determination of net loss and were accumulated in a separate component of accumulated other comprehensive income (loss) in stockholders’ (deficit) equity. Effective January 1, 2007, the financial statements of Targanta Québec were measured using the United States dollar as the functional currency. As a result of this change in functional currency, beginning with January 1, 2007, translation adjustments resulting from the financial statements of Targanta Québec are included in the determination of net loss. Translation adjustments resulting from the financial statements of Targanta Ontario which uses the United States dollar as the functional currency are included in the determination of net loss.

Income taxes

The Company uses the liability method to account for income taxes in accordance with SFAS No. 109, Accounting for Income Taxes and in accordance with FIN 48 effective January 1, 2007. Deferred tax assets and liabilities are determined for the expected future tax consequences of temporary differences between the Company’s consolidated financial statement carrying amounts and the tax basis of assets and liabilities using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. A valuation allowance is provided to reduce the deferred tax assets to the amount that will more likely than not be realized.

 

F-21


Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

2. Restatement and summary of significant accounting policies (continued)

 

Investment tax credits and government assistance

Canadian federal and Québec and Ontario provincial investment tax credits are accounted for as a reduction of the income tax expense in the period in which the credits are earned and when there is reasonable assurance of their recovery.

Government assistance in connection with research and development activities is recognized as a reduction of research and development expense in the period that the related expenditure is incurred.

Guarantees

As permitted under Delaware law, the Company indemnifies its officers and directors for certain events or occurrences while the officer or director is, or was, serving at the Company’s request in such capacity. The maximum potential amount of future payments the Company could be required to make is unlimited; however, the Company has directors and officers’ insurance coverage that limits its exposure and enables it to recover a portion of any future amounts paid.

The Company is a party to a number of agreements entered into in the ordinary course of business that contain typical provisions that obligate the Company to indemnify the other parties to such agreements upon the occurrence of certain events. Such indemnification obligations are usually in effect from the date of execution of the applicable agreement for a period equal to the applicable statute of limitations. The aggregate maximum potential future liability of the Company under such indemnification provisions is uncertain.

The Company leases office space under several non-cancelable operating leases. The Company has a standard indemnification arrangement under the leases that requires it to indemnify the landlords against all costs, expenses, fines, suits, claims, demands, liabilities, and actions directly resulting from any breach, violation, or nonperformance of any covenant or condition of the Company’s leases.

As of December 31, 2005 and 2006 and March 31, 2007, the Company had not experienced any material losses related to these indemnification obligations and no material claims with respect thereto were outstanding. The Company does not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established.

Segment and geographic information

SFAS No. 131, Disclosures about Segments of an Enterprise and Related Information , established standards for reporting information about operating segments in annual financial statements and requires selected information about operating segments to be presented in interim financial reports issued to stockholders. It also established standards for disclosures about products and services and geographic areas. Operating segments are defined as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment and the Company operates in only two geographic segments, the United States and Canada.

 

F-22


Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

2. Restatement and summary of significant accounting policies (continued)

 

The Company’s long-lived assets included the following:

 

    

May 31,

2004

  

May 31,

2005

   December 31,
2005
   December 31,
2006
   March 31,
2007
                         (unaudited)

Property and equipment

              

Domestic

   $ —      $ —      $ —      $ 118,904    $ 210,584

Canada

     1,566,317      1,363,010      1,165,138      765,138      688,103
                                  

Total

   $ 1,566,317    $ 1,363,010    $ 1,165,138    $ 884,042    $ 898,687
                                  

Recent accounting pronouncements

In July 2006, the Financial Accounting Standards Board (“ FASB ”) issued Interpretation No. 48, (“ FIN 48 ”), Accounting for Uncertainty in Income Taxes—an interpretation of FASB Statement No. 109 . FIN 48 clarifies the recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. FIN 48 also provides guidance on recognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. FIN 48 is effective for fiscal years beginning after December 15, 2006. The adoption of FIN 48 did not have a material effect on the Company’s financial position or results of operations.

In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements , which defines fair value, establishes a framework for measuring fair value under GAAP, and expands disclosures about fair value measurements. SFAS No. 157 applies to other accounting pronouncements that require or permit fair value measurements. The new guidance is effective for financial statements issued for fiscal years beginning after November 15, 2007, and for interim periods within those fiscal years. The Company is currently evaluating the requirements of SFAS No. 157; however, it does not believe that the adoption of SFAS No. 157 will have a material effect on its consolidated financial statements.

Reclassifications

Certain reclassifications were made to prior year balances to conform to the March 31, 2007 presentation.

3. Strategic agreements

The Company has entered into research, development, technology transfer and commercialization arrangements with pharmaceutical and biotechnology companies relating to different therapeutic products. These agreements may require the Company to pay various combinations of license fees, additional payments contingent upon the Company’s achievement of research and regulatory milestones and royalties if the Company is successful in developing and commercializing products.

InterMune, Inc.

On December 23, 2005, the Company entered into an Asset Purchase Agreement with InterMune, Inc. (“ InterMune ”) whereby the Company purchased the worldwide patent rights to the oritavancin compound and related assets from InterMune. The terms of the Asset Purchase Agreement include an initial payment of $1.0 million at closing, a second $1.0 million payment to InterMune in December 2006, a contingent milestone

 

F-23


Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

3. Strategic agreements (continued)

 

payment of $2.0 million when the Company receives FDA authorization to conduct clinical studies and an additional contingent milestone payment of $5.0 million upon receiving approval from the FDA necessary for the sale of oritavancin in the United States. The terms of the Asset Purchase Agreement also included a payment of $1.0 million at closing to Eli Lilly and Company (“ Lilly ”). InterMune also received a seat on the Company’s Board of Directors. The Company paid to InterMune the $1.0 million payments in each of December 2005 and December 2006 and paid the $2.0 million milestone payment in January 2007 upon receiving FDA authorization to conduct clinical studies. In January 2006 the Company paid to Lilly the $1.0 million due in December 2005. The initial payments to InterMune and Lilly were recorded as acquired in-process research and development expenses in the consolidated financial statements for the seven-month period ended December 31, 2005. The milestone payment made to InterMune in January 2007 was recorded as acquired in-process research and development expenses in the consolidated financial statements for the three months ended March 31, 2007. The Company also issued an interest free convertible promissory note to InterMune initially valued at $13.0 million in principal that, assuming certain clinical milestones are achieved, could be valued at up to $25.0 million in principal, which note is initially secured by the oritavancin assets (see Note 9). The Company recorded the present value of this convertible promissory note of approximately $8.8 million at December 31, 2005 as acquired in-process research and development expenses. Upon the closing of a third party financing by the Company resulting in gross proceeds to the Company of at least $10.0 million, the note automatically converts into convertible preferred stock of the Company, subject to certain limitations in the amount of voting stock that InterMune may hold. As discussed in Note 9, the convertible promissory note converted into 956,794 shares of convertible preferred stock in February 2007 when the Company closed on its Series C convertible preferred stock financing.

Eli Lilly and Company

In connection with the December 23, 2005 closing of the Asset Purchase Agreement, InterMune assigned to the Company its rights to oritavancin under a License Agreement between InterMune and Lilly. Under the License Agreement, the Company received an exclusive license from Lilly for the worldwide rights to develop and commercialize oritavancin in exchange for future milestone and royalty payments.

The Company will make a $10.0 million milestone payment upon receiving FDA (or equivalent foreign regulatory agency) approval for the first indication (as defined in the License Agreement) and a second $10.0 million milestone payment to Lilly upon receiving FDA (or equivalent foreign regulatory agency) approval for a second indication (as defined in the License Agreement). A $15.0 million milestone payment will also be made in the first year that the Company exceeds certain revenue amounts defined in the License Agreement. The Company has not made any milestone or royalty payments under the License Agreement through March 31, 2007.

The Company’s rights to the licensed products under the License Agreement could revert to Lilly if the Company commits a material breach of the agreement. The License Agreement will, in general, expire for each country in which licensed product is sold ten years from the date of first commercial sale in such country, or if there is a valid and enforceable claim that would preclude the sale or other disposition of licensed product in such country, the period of time from the effective date of the License Agreement until the expiration in such country of the last valid and enforceable claim. Following expiration of the License Agreement in any country, the Company will retain in such country a fully paid-up, perpetual, irrevocable, exclusive, sublicenseable license to the patents, know-how, and other intellectual property rights licensed under the License Agreement.

 

F-24


Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

3. Strategic agreements (continued)

 

ElizaNor Biopharmaceuticals, Inc.

On November 8, 2005, the Company entered into a license agreement (the “ ElizaNor License Agreement ”) with ElizaNor Biopharmaceuticals, Inc. (“ ElizaNor ”) under which the Company received a worldwide non-exclusive license to develop and commercialize licensed products based on patents and technology related to therapeutic derivatives of diphosphonates in exchange for future fees and royalty payments. On June 30, 2006, the Company and ElizaNor amended the ElizaNor License Agreement to update certain payment terms. The Company paid ElizaNor a technology access fee of $110,000 in December 2005 that was charged to research and development in that period and will pay a license fee of approximately $1.1 million consisting of $300,000 in time based payments and $850,000 in contingent payments. The Company made a license fee payment of $55,000 in 2006 and $245,000 in January 2007, both of which were accrued for and charged to research and development expenses in the seven-month period ended December 31, 2005. The following milestone payments will also be due under the ElizaNor License Agreement (as amended): (i) $100,000 when the Company files its first investigational new drug application with the FDA for a licensed product, (ii) $250,000 at the time of a successful phase 2 meeting with the FDA relating to the first licensed product, and (iii) $500,000 payment when the Company receives FDA approval for the first licensed product.

The Company’s rights to the licensed products under the ElizaNor License Agreement could revert to ElizaNor if the Company commits a material breach of the agreement. The ElizaNor License Agreement will automatically terminate, on a country-by-country basis, upon the expiry of the last to expire patents in the relevant country.

McGill University

Pursuant to a license agreement with McGill University, the Company has agreed to pay a royalty of 2% of its net revenues stemming from products derived from its phage technology through 2012.

4. Short-term investments

Short-term investments included the following at December 31, 2005 and 2006 and March 31, 2007:

 

     Amortized
cost
   Unrealized
gains
   Unrealized
losses
   Fair value

December 31, 2005—Guaranteed investment certificate

           

Due in one year or less

   $ 428,816    $ —      $ —      $ 428,816
                           
   $ 428,816    $ —      $ —      $ 428,816
                           

December 31, 2006—Guaranteed investment certificate

           

Due in one year or less

   $ 429,074    $ —      $ —      $ 429,074
                           
   $ 429,074    $ —      $ —      $ 429,074
                           

March 31, 2007 (unaudited)—Guaranteed investment certificate

           

Due in one year or less

   $ 433,050    $ —      $ —      $ 433,050
                           
   $ 433,050    $ —      $ —      $ 433,050
                           

 

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Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

 

The Company reviews its investments for other-than-temporary impairment whenever the fair value of an investment is less than amortized cost and evidence indicates that an investment’s carrying amount is not recoverable within a reasonable period of time. To determine whether an impairment is other-than-temporary, the Company considers whether it has the ability and intent to hold the investment until a market price recovery and considers whether evidence indicating the cost of the investment is recoverable outweighs evidence to the contrary.

The cost of securities sold is determined based on the specific identification method for purposes of recording realized gains and losses.

5. Property and equipment

Property and equipment consists of the following:

 

    

Estimated

useful life

   December 31,     March 31,
2007
 
        2005     2006    
                      (unaudited)  

Computer equipment

   3 years    $ 153,151     $ 280,923     $ 271,584  

Machinery and equipment

   3 to 5 years      2,578,519       2,588,138       2,582,390  

Furniture and fixtures

   5 years      63,063       107,723       149,584  

Leasehold improvements

   2 to 10 years      520,223       520,536       604,181  
                           
        3,314,956       3,497,320       3,607,739  

Less: Accumulated depreciation

        (2,149,818 )     (2,613,278 )     (2,709,052 )
                           
      $ 1,165,138     $ 884,042     $ 898,687  
                           

Depreciation and amortization expense, which includes amortization of assets recorded under capital leases, was $388,449 and $469,311 for the years ended May 31, 2004 and 2005, respectively, $296,594 for the seven months ended December 31, 2005, $474,326 for the year ended December 31, 2006, $118,221 and $95,774 for the three months ended March 31, 2006 and 2007, respectively, and $2,436,613 for the period from May 20, 1997 (date of inception) to March 31, 2007.

6. Accrued expenses

Accrued expenses consist of the following:

 

     December 31,    March 31,
2007
     2005    2006   
               (unaudited)

Payroll and benefits

   $ 37,683    $ 590,792    $ 652,992

Accrued payments on Asset Purchase Agreement

     2,000,000      —        —  

License fees

     300,000      258,900      —  

Professional fees

     582,965      229,817      468,255

Other expenses

     206,996      280,044      564,905
                    
   $ 3,127,644    $ 1,359,553    $ 1,686,152
                    

 

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Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

7. Patent costs

 

The Company incurred patent costs and charged to operations $132,892 and $99,584 for the years ended May 31, 2004 and 2005, respectively, $432,929 for the seven months ended December 31, 2005, $680,881 for the year ended December 31, 2006, $155,576 and $322,867 for the three months ended March 31, 2006 and 2007, respectively, and $2,142,692 for the period from May 20, 1997 (date of inception) to March 31, 2007. These costs were charged to general and administrative expenses.

8. Commitments

Lease obligations

The Company conducts its operations in leased facilities with a combination of leased and owned equipment. At December 31, 2005 and 2006 and March 31, 2007, the Company has equipment under capital leases totaling $1,471,542, $1,491,046 and $1,472,943, respectively, with related accumulated depreciation of $1,170,587, $1,370,753 and $1,398,265, respectively. Such amounts are included in the appropriate categories of property and equipment in Note 5.

The Company leases its laboratory and office space under operating lease agreements with various terms and renewal options with lease expirations ranging from 2008 through 2012. In addition to minimum lease commitments, these lease agreements require the Company to pay its pro rata share of property taxes and building operating expenses.

Future minimum lease payments under noncancelable operating leases as of December 31, 2006 are approximately as follows:

 

Year Ending December 31,

  

2007

   $ 366,700

2008

     301,400

2009

     195,000

2010

     194,000

2011

     198,100

Thereafter

     66,500
      
   $ 1,321,700
      

Total rent expense, which includes rent for buildings and equipment, was $367,392 and $511,194 for the years ended May 31, 2004 and 2005, respectively, $364,008 for the seven months ended December 31, 2005, $869,795 for the year ended December 31, 2006, $174,532 and $264,336 for the three months ended March 31, 2006 and 2007, respectively, and $2,858,753 for the period from May 20, 1997 (date of inception) to March 31, 2007.

 

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Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

9. Convertible debt

 

Convertible debt consists of the following:

 

     December 31,     March 31,
2007
     2005     2006    
                 (unaudited)

First Tranche Convertible Notes, 8% interest, due on or after October 24, 2006

   $ 333,059     $ 1,640,939     $  —  

Second Tranche Convertible Notes, 8% interest, due on or after October 24, 2006

     506,291       11,142,060       —  

InterMune Convertible Note, non-interest bearing, due December 23, 2010

     8,863,096       9,570,903       —  

Convertible Debentures, 8% interest, due June 30, 2007

     —         6,162,164       —  
                      
     9,702,446       28,516,066       —  

Less: Current portion of convertible debt

     (839,350 )     (18,945,163 )     —  
                      

Long-term portion of convertible debt

   $ 8,863,096     $ 9,570,903     $  —  
                      

First tranche convertible notes

On October 24, 2005, the Company completed the first tranche of a two tranche convertible note financing (“ First Tranche Convertible Notes ”) for gross proceeds of approximately $1.5 million (CAN$1.7 million). At December 31, 2006, the First Tranche Convertible Notes, plus accrued interest, are convertible into 8,225 shares of Series B Redeemable Convertible Preferred Stock.

In conjunction with the sale of the First Tranche Convertible Notes, the Company issued to the purchasers of the First Tranche Convertible Notes warrants exercisable for a total of 5,600 shares of Series B Redeemable Convertible Preferred Stock at an exercise price of $1.29 per share. These warrants were exercised on December 23, 2005 for gross proceeds to the Company of approximately $7,200.

Second tranche convertible notes

On December 23, 2005, the Company sold the second tranche of convertible notes (“ Second Tranche Convertible Notes ”) for gross proceeds of $10.3 million (together with the First Tranche Convertible Notes, the “ Convertible Notes ”). At December 31, 2006, the Second Tranche Convertible notes, plus accrued interest, are convertible into 55,849 shares of Series B Redeemable Convertible Preferred Stock.

In conjunction with the sale of the Second Tranche Convertible Notes, the Company issued to the purchasers of the Second Tranche Convertible Notes warrants exercisable for a total of 41,197 shares of Series B Redeemable Convertible Preferred Stock at an exercise price of $1.50 per share. These warrants were exercised on December 23, 2005 for gross proceeds to the Company of approximately $61,800.

The Convertible Notes bear interest at 8% per annum and are due on or after October 24, 2006 upon written demand by holders of 60% of the total outstanding Convertible Notes. The Convertible Notes can not be repaid until such time that the IQ Loan Facility (as defined in Note 10 below) is repaid in full and the Convertible Notes remained outstanding at December 31, 2006.

 

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Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

9. Convertible debt (continued)

 

The Convertible Notes automatically convert into equity securities to be issued by the Company during the next round of third party financing in which the Company receives gross proceeds of at least $10.0 million, the terms of which will be determined at such time the financing occurs. Holders of the First Tranche Convertible Notes are entitled to convert their notes at a 50% discount to the per share price paid in the third party financing. Holders of the Second Tranche Convertible Notes are entitled to convert their notes at the per share price paid in the third party financing. At the option of the holders, the Convertible Notes are convertible into shares of Series B Redeemable Convertible Preferred Stock at any time prior to redemption or mandatory conversion at the original Series B Redeemable Convertible Preferred Stock issue price.

The Convertible Notes were accounted for in accordance with the provisions of Accounting Principles Board Opinion No. 14, Accounting for Convertible Debt and Debt Issued with Stock Purchase Warrants (“ APB No. 14 ”), EITF Issue No. 98-5, Accounting for Convertible Securities with Beneficial Conversion Features or Contingently Adjustable Conversion Ratios (“EITF 98-5”) and EITF Issue No. 00-27, Application of Issue No. 98-5 to Certain Convertible Instruments (“EITF 00-27”).

Under the provisions of APB No. 14, the Company allocated the proceeds received from the issuance of the Convertible Notes between the debt and the warrants to purchase Series B Redeemable Preferred Stock based on their relative fair values at the time of issuance. The fair value of the warrants was determined using the Black-Scholes option pricing model with a volatility factor of 35.9%, a risk free interest rate of 4.3%, no dividend yield and a contractual life of 3 years. The fair value of the Convertible Notes was determined using a discounted cash flow model with a 35% discount rate. Based on the relative fair values of the warrants and the First Tranche Convertible Notes, approximately $777,000 of the proceeds from the First Tranche Convertible Notes were allocated to the debt and approximately $723,000 of proceeds were allocated to the warrants. Based on the relative fair values of the warrants and the Second Tranche Convertible Notes, approximately $5.3 million of the proceeds from the Second Tranche Convertible Notes were allocated to the debt and approximately $5.0 million of proceeds were allocated to the warrants. The discount on the Convertible Notes is being amortized to interest expense in the consolidated statements of operations over the term of the respective Convertible Notes.

In accordance with the guidance included in EITF 98-5 and EITF 00-27, the Company recorded approximately $721,000 of the proceeds allocated to the First Tranche Convertible Notes and approximately $5.0 million of the proceeds allocated to the Second Tranche Convertible Notes as a beneficial conversion feature with a corresponding credit recorded as additional paid-in capital. The respective beneficial conversion feature is being amortized as additional debt discount over the term of the respective Convertible Notes and recorded as interest expense in the consolidated statements of operations.

Approximately $513,900, $11,032,200, $3,229,600 and $0 of interest expense for the seven months ended December 31, 2005, the year ended December 31, 2006 and the three months ended March 31, 2006 and 2007, respectively, was attributable to the amortization of the debt discount on the Convertible Notes.

The Convertible Notes, plus accrued interest, automatically converted into 1,388,008 shares of Series C-1 Convertible Preferred Stock on January 31, 2007 (see Note 13) upon the closing of the Company’s Series C financing. Holders of the First Tranche Convertible Notes converted their notes at a 50% discount to the Series C price of $10.45157 per share and holders of the Second Tranche Convertible Notes converted their notes at the Series C price of $10.45157 per share.

 

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Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

9. Convertible debt (continued)

 

InterMune convertible note

On December 23, 2005, the Company issued a Senior Secured Convertible Acquisition Note (the “ InterMune Convertible Note ”) to InterMune as part of the purchase of the worldwide patent rights to the oritavancin compound and related assets. The InterMune Convertible Note is in the original principal amount of $13.0 million (subject to certain adjustments described below), only bears interest in certain limited circumstances (for example, upon a payment default), is due on December 23, 2010 and is secured by the oritavancin assets.

Upon the closing of a next round of third party financing resulting in gross proceeds (exclusive of amounts related to converted debt) of at least $10.0 million, the principal amount of the InterMune Convertible Note automatically decreases by $3.0 million to $10.0 million, unless this third party financing occurs after the occurrence of the two milestones described below, in which case no downward adjustment to the principal amount of the InterMune Convertible Note will occur.

Upon the Company’s receipt of authorization from the FDA to conduct clinical trials (the “ First Milestone ”), if a qualified third party financing has occurred, then the principal amount of the InterMune Convertible Note automatically increases by $7.5 million. Otherwise, upon achieving the First Milestone, the InterMune Convertible Note will automatically increase by $6.0 million.

Additionally, upon the Company’s receipt of FDA authorization to conduct clinical efficacy studies of the product in patients with a specified dose (the “ Second Milestone ”), if a qualified third party financing has occurred, the principal amount of the InterMune Convertible Note automatically increases by an additional $7.5 million. Otherwise, upon achieving the Second Milestone, the InterMune Convertible Note will automatically increase by $6.0 million.

The initial balance on the InterMune Convertible Note will automatically convert on the date of the closing of a qualified third party financing into shares issued in that financing. The number of new shares to be issued upon conversion is equal to the principal and interest, if any, then outstanding under the InterMune Convertible Note divided by the per share purchase price of the new shares, subject to certain ownership limitations. Subsequent increases in the principal amount of the InterMune Convertible Note will automatically convert into the newly issued shares using the same per share purchase price, subject to certain ownership limitations.

The Company accounted for the InterMune Convertible Note in accordance with APB No. 14 and used a discounted cash flow model with an incremental borrowing rate of 8% to determine the fair value of the InterMune Convertible Note. At December 23, 2005, the Company determined that the fair value of the InterMune Convertible Note was approximately $8.8 million. The discount on the InterMune Convertible Note is being amortized to interest expense in the consolidated statements of operations over the term of the note, or five years. The Company has determined that there was no beneficial conversion feature related to the InterMune Convertible Note.

Approximately $15,500, $707,800, $177,000 and $60,100 of interest expense for the seven months ended December 31, 2005, the year ended December 31, 2006 and the three months ended March 31, 2006 and 2007, respectively, was attributable to the amortization of the debt discount on the InterMune Convertible Note.

 

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Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

9. Convertible debt (continued)

 

At December 31, 2006, the Company had not achieved either the First Milestone or Second Milestone and the Company had not consummated a qualifying next round of financing. In January 2007, upon the closing of the Company’s Series C financing, the outstanding principal under the InterMune Convertible Note was reduced to $10.0 million and converted into 956,794 shares of Series C-1 Convertible Preferred Stock (see Note 13). Accordingly, the carrying value of the InterMune Convertible Note at the conversion date was increased from approximately $9.6 million to approximately $10.0 million, with an approximately $400,000 charge to interest expense and the Company recorded an approximately $10.0 million credit to Series C-1 Convertible Preferred Stock. Also in January 2007, the Company achieved the First Milestone whereby the outstanding principal under the InterMune Convertible Note increased by $7.5 million, which was then converted into 358,797 shares of Series C-2 Convertible Preferred Stock and 358,798 shares of Series C-3 Convertible Preferred Stock. Accordingly, the Company recorded $7.5 million as additional acquired in-process research and development expenses in the three months ended March 31, 2007. In conjunction with the conversion of the InterMune Convertible Note and the achievement of the First Milestone, the Company issued warrants to purchase a total of 82,955 shares of Series C-1 Convertible Preferred Stock to InterMune.

As a result, as of March 31, 2007, there is no outstanding balance under the InterMune Convertible Note and the balance potentially due and payable to InterMune if the Company achieves the Second Milestone is $7.5 million, which amount will automatically convert into 358,798 shares of Series C-2 Convertible Preferred Stock and 358,797 shares of Series C-3 Convertible Preferred Stock. The Company will also issue a warrant for up to 35,553 shares of Series C-1 Convertible Preferred Stock to InterMune upon its achievement of the Second Milestone.

Convertible debentures

On December 7, 2006 and December 19, 2006, the Company sold a total of approximately $14.0 million of convertible debentures (the “ Convertible Debentures ”) to existing investors in a bridge financing. The Convertible Debentures bear interest at an 8% annual rate and mature on June 30, 2007. The Convertible Debentures automatically convert into equity securities to be issued by the Company during the next round of third party financing in which the Company receives gross proceeds of at least $25.0 million. At the option of the holders, if a new round of third party financing has not occurred by March 31, 2007, the Convertible Debentures, plus accrued interest, are convertible into newly created shares of Series B-2 Convertible Redeemable Preferred Stock at a price equal to the lesser of (a) 75% of the issue price received for any class or series of the Company in connection with the last equity financing completed by the Company prior to the date upon which the Convertible Debentures may be converted; and (b) $123.00 per share. If no such shares of Series B-2 Convertible Redeemable Preferred Stock then exist, the conversion shall be into shares of Series B Redeemable Convertible Preferred Stock. At December 31, 2006, the Convertible Debentures, plus accrued interest, are convertible into 114,601 shares of Series B Redeemable Convertible Preferred Stock.

The Convertible Debentures were accounted for in accordance with the provisions of APB No. 14, EITF 98-5 and EITF 00-27, and the Company recorded approximately $8.7 million of the proceeds of the Convertible Debentures as a beneficial conversion feature. This amount represents the difference between the conversion price of the Convertible Debentures and the underlying value of the Series B Redeemable Convertible Preferred Stock issuable upon conversion of the Convertible Debentures. The beneficial conversion feature is being amortized as debt discount over the term of the Convertible Debentures and recorded as interest expense in the consolidated statements of operations.

 

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Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

9. Convertible debt (continued)

 

Approximately $790,600, $0 and $912,400 of interest expense for the year ended December 31, 2006 and the three months ended March 31, 2006 and 2007, respectively, was attributable to the amortization of the beneficial conversion feature.

The Convertible Debentures, plus accrued interest, automatically converted into 16,215 shares of Series C-1 Convertible Preferred Stock, 671,091 shares of Series C-2 Convertible Preferred Stock and 671,091 shares of Series C-3 Convertible Preferred Stock on January 31, 2007 (see Note 13) upon the closing of the Company’s Series C financing. Holders of the Convertible Debentures converted their notes at the Series C price of $10.45157 per share. As a result of the conversion of the Convertible Debentures, approximately $7.0 million of unamortized beneficial conversion feature was reversed and charged to additional paid-in capital.

Deferred financing costs

The Company paid approximately $278,500 and $428,800 in financing costs in connection with the issuance of the Convertible Notes, InterMune Convertible Note and Convertible Debentures in the seven months ended December 31, 2005 and the year ended December 31, 2006, respectively. These expenses have been deferred and are included in deferred financing costs on the consolidated balance sheets. These deferred financing costs are being expensed over the terms of the respective debt. The Company recognized $6,028, $326,002, $89,686 and $338,233 of interest expense related to the amortization of the deferred financing costs during the seven months ended December 31, 2005, the year ended December 31, 2006 and the three months ended March 31, 2006 and 2007, respectively.

10. Note Payable

In April 2004, the Company executed a loan agreement with Investissement Québec (“ IQ ”) under the Biolevier program for a loan facility of approximately $6.9 million (CAN$8.0 million) (the “ IQ Loan Facility ”). As of December 31, 2006, the full IQ Loan Facility was drawn. Interest expense on the IQ Loan Facility was $0 and $151,512 for the years ended May 31, 2004 and 2005, respectively, $249,235 for the seven months ended December 31, 2005 and $681,461 for the year ended December 31, 2006 and $149,963 and $176,726 for the three months ended March 31, 2006 and 2007, respectively. All interest expense related to the IQ Loan Facility has been capitalized as part of the IQ Loan Facility.

The significant terms and conditions of the IQ Loan Facility are as follows:

 

  i.   The loan is repayable annually at a rate of 25% of net income per year over a period not exceeding ten years from the date of the first disbursement, which was August 19, 2004.

 

  ii.   No capital or interest is repayable for the first three years after the initial disbursement.

 

  iii.   Interest is at IQ’s own prime rate plus 1.5% (8.0% at December 31, 2005 and 9.0% at December 31, 2006 and March 31, 2007).

 

  iv.   The IQ Loan Facility is collateralized by a first ranking hypothec of approximately $9.4 million (CAN$11.0 million) and additional hypothec of approximately $1.9 million (CAN$2.2 million) on all current and future assets of the Company, including property and equipment and intellectual property, but excluding all the oritavancin assets acquired from InterMune under the Asset Purchase Agreement in December 2005.

 

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Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

10. Note Payable (continued)

 

  v.   As part of the IQ Loan Facility, the Company granted IQ warrants to purchase up to 6,837 shares of Series B Convertible Preferred Stock (on an as-if exchanged basis), exercisable for the period from the date of the first disbursement of the funds up to the first anniversary date of the final reimbursement of the IQ Loan Facility, at an exercise price of CAN$234.00 per share. IQ is entitled to receive additional warrants if the Company declares a dividend on the Series B Redeemable Convertible Preferred Stock, and subsequent to January 31, 2007, on the Series B Convertible Preferred Stock, and such dividend is paid in shares of the Company’s capital stock. At December 31, 2006, IQ is entitled to receive warrants for the purchase of 1,036 additional shares of Series B Redeemable Convertible Preferred Stock as it relates to the accretion of dividends on the warrants. At March 31, 2007, IQ is entitled to receive warrants for the purchase of 1,363 additional shares of Series B Convertible Preferred Stock as a result of the stock dividend paid on January 31, 2007.

The Company recorded the fair value of the warrants of $693,773 as a discount to the IQ Loan Facility and is amortizing the discount to interest expense over the 10 year term of the IQ Loan Facility using the straight-line method until the timing and amount of capital repayments are known, at which time it will be amortized using the effective yield method. As the warrants were originally issued for the purchase of shares of Series B Redeemable Convertible Preferred Stock, the offsetting credit was recorded as warrants to purchase shares subject to redemption in long-term liabilities in accordance with SFAS No. 150 (“ SFAS No. 150 ”), Accounting for Certain Financial Instruments with Characteristics of Both Liabilities and Equity and FASB Staff Position No. 150-5 (“ FSP 150-5 ”) Issuer’s Accounting under FASB Statement No. 150 for Freestanding Warrants and Other Similar Instruments on Shares that Are Redeemable . The fair value of the warrants was calculated using the Black-Scholes option pricing model with the following assumptions: fair value of Series B Redeemable Convertible Preferred Stock of $1.33, weighted average volatility factor of 35.0%, a weighted average risk-free interest rate of 4.25%, no dividend yield and a contractual life of 10 years. The warrants are revalued each reporting period, with the resulting change in fair value recorded in interest expense. At December 31, 2005, the fair value of the warrants was calculated using the Black-Scholes option pricing model with the following assumptions: fair value of Series B Redeemable Convertible Preferred Stock of $1.33, volatility factor of 33.8%, risk-free interest rate of 4.39%, no dividend yield and a remaining contractual life of 9.7 years. At December 31, 2006, the fair value of the warrants was calculated using the Black-Scholes option pricing model with the following assumptions: fair value of Series B Redeemable Convertible Preferred Stock of $1.33, volatility factor of 67.2%, risk-free interest rate of 4.52%, no dividend yield and a remaining contractual life of 8.7 years. At March 31, 2007, the fair value of the warrants was calculated using the Black-Scholes option pricing model with the following assumptions: fair value of Series B Convertible Preferred Stock of $199.50, volatility factor of 64.1%, risk-free interest rate of 4.62%, no dividend yield and a remaining contractual life of 8.4 years. The Company recognized $34,867, $21,785, $402,646, $351,645, $176,861 and $636,160 of interest expense related to the amortization of the discount to the IQ Loan Facility and the change in fair value of the warrant during the year ended May 31, 2005, the seven months ended December 31, 2005, the year ended December 31, 2006, the three months ended March 31, 2006 and 2007 and the period from May 20, 1997 (date of inception) through March 31, 2007, respectively.

In accordance with the terms of the IQ Loan Facility, on May 11, 2004 the Company modified the rights, privileges, restrictions and terms of the Series B Redeemable Convertible Preferred Stock so that as long as a balance on the IQ Loan Facility remains outstanding, the Series B Redeemable Convertible Preferred Stock may not be redeemed on or after January 30, 2007 and dividends declared on these Series B Redeemable Convertible Preferred Stock must be settled with the issuance of additional Series B Redeemable Convertible Preferred Stock.

 

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Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

10. Note Payable (continued)

 

On January 30, 2007, the Company and IQ amended the IQ Loan Facility to change the payment terms so that the Company must pay all outstanding principal and accrued interest under the IQ Loan Facility by June 30, 2008.

Upon the filing of the Company’s Second Amended and Restated Certificate of Incorporation on January 31, 2007, the Series B Redeemable Convertible Preferred Stock is no longer redeemable at the option of the holders of the Series B Redeemable Convertible Preferred Stock and no longer has a cumulative annual dividend (now referred to as the “Series B Convertible Preferred Stock”, see Note 13). The warrants remain classified as a long-term liability as IQ, after exercising the warrants, has the option of requiring the Company to repurchase the Series B Convertible Preferred Stock issued as a result of the exercise of warrants at the Series B Convertible Preferred Stock fair value as defined in the IQ Loan Facility.

11. Credit facility

The Company has an available credit facility of approximately $429,000 (CAN$500,000), comprised of a credit line of approximately $240,000 (CAN$280,000) and letters of guarantee maturing on March 27, 2007 issued in favor of Société Immobilière Technologique amounting to approximately $189,000 (CAN$220,000). The credit line bears interest at a Canadian chartered bank’s prime rate. The credit facility is collateralized by a moveable first rank hypothec on a temporary investment of approximately $429,000 (CAN$500,000). As of December 31, 2005 and 2006 and March 31, 2007, no amounts had been drawn against this facility. The prime rate was 5.0% at December 31, 2005 and 6.0% at December 31, 2006 and March 31, 2007.

12. Redeemable convertible preferred stock

Redeemable convertible preferred stock, on an as-if exchanged basis, consists of the following:

 

     Carrying value at
December 31,
2005
   Carrying value at
December 31,
2006
  

Carrying value at
March 31,

2007

     Restated    Restated    (unaudited)

Series B Redeemable Convertible Preferred Stock, par value $0.0001; authorized 333,333 and 455,333 shares at December 31, 2005 and 2006, respectively, and no shares at March 31, 2007; 115,169 shares issued and outstanding at December 31, 2005 and 2006 and no shares at March 31, 2007, net of issuance costs

   $ 9,871,192    $ 9,871,192    $ —  

Accretion of dividends

     3,222,629      5,102,356      —  
                    

Total redeemable convertible preferred stock

   $ 13,093,821    $ 14,973,548    $ —  
                    

The Company has accrued the potential Canadian Part VI.I tax, related to the cumulative dividend on the Series B Redeemable Convertible Preferred Stock. This accrued amount relates to the Part VI.I tax that could be due on dividends and is generally payable by the issuer upon the payment of dividends or on the repurchase of the shares of Series B Redeemable Convertible Preferred Stock at values in excess of their issue price (see Note 15). On payment of this tax, the Company will be entitled to claim a Canadian tax deduction equal to nine-fourths the amount of any Part VI.I taxes actually paid. The benefit of this deduction has not been recorded in the consolidated financial statements.

 

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Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

12. Redeemable convertible preferred stock (continued)

 

In January 2002, the Company issued 34,186 shares of Series B Redeemable Convertible Preferred Stock at $147.07 per share for net proceeds of $4,906,249.

In February 2003, the Company issued 34,186 shares of Series B Redeemable Convertible Preferred Stock at $154.49 per share for net proceeds of $5,265,223.

In December 2005, the Company issued 46,797 shares of Series B Redeemable Convertible Preferred Stock upon the exercise of warrants for net proceeds of $67,576.

In December 2005, the Company incurred stock issuance costs related to the reorganization of which $367,856 was related to the Series B Redeemable Convertible Preferred Stock.

The Series B Redeemable Convertible Preferred Stock has the following characteristics:

Voting

The holders of the Series B Redeemable Convertible Preferred Stock are entitled to vote, together with the holders of Common Stock, on all matters submitted to stockholders for a vote under the applicable provisions of Delaware General Corporation Law. Each Series B Redeemable Convertible Preferred Stock stockholder is entitled to the number of votes equal to the number of shares of Common Stock into which the Series B Redeemable Convertible Preferred Stock is convertible at the time of such vote.

Dividends

The holders of Series B Redeemable Convertible Preferred Stock are entitled to receive per share, in preference and in priority to any declaration and payment of dividends on the shares of all other classes or series of stock, a cumulative annual dividend at a rate of 8% per annum on the original issue price. As long as any balance is outstanding under the IQ Loan Facility, dividends declared on Series B Redeemable Convertible Preferred Stock shall be settled only by the issuance of additional Series B Redeemable Convertible Preferred Stock.

On January 31, 2007, the Company effected a stock dividend as payment for the accumulated dividends on the Series B Redeemable Convertible Preferred Stock by the issuance of 28,691 shares of Series B Redeemable Convertible Preferred Stock.

Liquidation preference

In the event of any liquidation, dissolution, or winding up of the affairs of the Company, the holders of the then-outstanding Series B Redeemable Convertible Preferred Stock are entitled to a liquidation preference equal to $199.50 per share, plus any accrued and unpaid dividends thereon.

Conversion

Each share of the Series B Redeemable Convertible Preferred Stock is convertible, at the option of the holder, at any time after the date of issuance of such share into such number of shares of Common Stock as is

 

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Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

12. Redeemable convertible preferred stock (continued)

 

determined by dividing (a) the sum of the original issue price in effect for the Series B Redeemable Convertible Preferred Stock by (b) the conversion price then in effect for Series B Redeemable Convertible Preferred Stock. The conversion of the Series B Redeemable Convertible Preferred Stock shall be on an adjusted basis to account for unpaid cumulative dividends and subject to a weighted average anti-dilution adjustment. Upon the closing of a qualified initial public offering, the shares of the Series B Redeemable Convertible Preferred Stock then outstanding shall automatically convert into shares of the Company’s Common Stock on a one-to-one basis, subject to adjustment for unpaid cumulative dividends and a weighted average anti-dilution adjustment.

Redemption

Shares of the Series B Redeemable Convertible Preferred Stock are redeemable on or after December 22, 2008, at the option of the holders, if holders of at least 60% of the then outstanding Series B Redeemable Convertible Preferred Stock vote together, at a price per share equal to the greater of (i) $199.50 per share, plus accrued but unpaid dividends or (ii) 110% of the fair market value, on an as-if-converted to Common Stock basis, of such share.

On January 31, 2007, the Company filed its Second Amended and Restated Certificate of Incorporation whereby the Series B Redeemable Convertible Preferred Stock is no longer redeemable at the option of the holders of the Series B Redeemable Convertible Preferred Stock and no longer has a cumulative annual dividend.

13. Stockholders (deficit) equity

Convertible preferred stock

Convertible Preferred Stock, on an as-if exchanged basis, consists of the following:

 

     December 31,    March 31,
     2005    2006    2007
               (unaudited)

Series A Convertible Preferred Stock, par value $0.0001; 20,000 shares authorized; 15,643 shares issued and outstanding, net of issuance costs

   $ 1,458,208    $ 1,458,208    $ 1,458,208

Series B Convertible Preferred Stock, par value $0.0001; 245,000 shares authorized; 143,860 shares issued and outstanding, net of issuance costs

     —        —        15,198,469

Series C-1 Convertible Preferred Stock, par value $0.0001; 3,200,000 shares authorized; 2,361,017 shares issued and outstanding, net of issuance costs

     —        —        22,557,451

Series C-2 Convertible Preferred Stock, par value $0.0001; 1,600,000 shares authorized; 1,081,171 shares issued and outstanding, net of issuance costs

     —        —        10,664,460

Series C-3 Convertible Preferred Stock, par value $0.0001; 9,500,000 shares authorized; 6,333,974 shares issued and outstanding, net of issuance costs

     —        —        64,199,018
                    

Total Convertible Preferred Stock

   $ 1,458,208    $ 1,458,208    $ 114,077,606
                    

 

F-36


Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

13. Stockholders (deficit) equity (continued)

 

In December 1997, the Company issued 15,643 shares of Series A Convertible Preferred Stock at $101.12 per share for net proceeds of $1,542,372.

In December 2005, the Company incurred stock issuance costs related to the reorganization of which $84,164 was related to the Series A Convertible Preferred Stock.

Upon filing of the Company’s Second Amended and Restated Certificate of Incorporation on January 31, 2007, the Series B Redeemable Convertible Preferred Stock was automatically converted into Series B Convertible Preferred Stock.

On January 31 and February 16, 2007, upon receipt of net proceeds of approximately $57.8 million (including the reinvestment of repaid Convertible Notes in the amount of approximately $2.2 million, including principal and accrued interest) and the conversion of approximately $34.9 million of principal and accrued interest on the Convertible Notes, the InterMune Convertible Note (reflecting the reduction in the principal amount from $13.0 million to $10.0 million) and the Convertible Debentures, the Company issued an aggregate of 2,361,017 shares of Series C-1 Convertible Preferred Stock, 722,374 shares of Series C-2 Convertible Preferred Stock, and 5,975,176 shares of Series C-3 Convertible Preferred Stock (collectively referred to as the “ Series C Convertible Preferred Stock ”). Such aggregate amounts include the Class C-1 Preferred Exchangeable Shares, Class C-2 Preferred Exchangeable Shares, and Class C-3 Preferred Exchangeable Shares (collectively referred to as the “ Class C Preferred Exchangeable Shares ”), on an as-if exchanged basis, issued by Targanta Ontario. In connection with the issuance of the Class C Preferred Exchangeable Shares, the Company issued 725,047 shares of Series C-1 Special Voting Stock, 448,640 shares of Series C-2 Special Voting Stock and 448,640 shares of Series C-3 Special Voting Stock (together the “ Series C Special Voting Stock ”).

In January 2007, the Company achieved the First Milestone under the InterMune Convertible Note and promptly increased the outstanding principal balance on the InterMune Convertible Note by $7.5 million. Thereafter, in early February 2007, the Company converted the increased balance under that note into 358,797 shares of Series C-2 Convertible Preferred Stock and 358,798 shares of Series C-3 Convertible Preferred Stock.

In connection with the Series C financing and the Company’s achievement of the First Milestone, the Company also issued warrants to purchase up to 403,976 shares of Series C-1 Convertible Preferred Stock and Targanta Ontario issued warrants to purchase up to 80,378 Class C-1 Preferred Exchangeable Shares (collectively, the “ Series C Warrants ”). The exercise price of the Series C Warrants is $13.06 per share and the Series C Warrants are exercisable for the shorter of (a) 5 years from the date of an initial public offering of the Company’s Common Stock or (b) 7 years from the date of issuance of the Series C Warrants. The Company also issued warrants to purchase up to 29,855 shares of Common Stock (the “ Common Stock Warrants ”). The exercise price of the Common Stock Warrants is $10.45157 per share and the Common Stock Warrants are exercisable for the shorter of (a) 5 years from the date of an initial public offering of the Company’s Common Stock or (b) 7 years from the date of issuance of the Common Stock Warrants.

The conversion of the Convertible Notes, InterMune Converible Note and the Convertible Debentures along with the proceeds of the issuance of the Series C Convertible Preferred Stock and related warrants were accounted for in accordance with the provisions of APB No. 14, EITF 98-5 and EITF 00-27.

Under the provisions of APB No. 14, the Company allocated the conversion of the convertible debt and proceeds received from the issuance of the Series C Convertible Preferred Stock between the Series C Convertible

 

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Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

13. Stockholders (deficit) equity (continued)

 

Preferred Stock, the Series C Warrants and the Common Stock Warrants based on their relative fair values at the time of issuance. The Company performed a retrospective valuation of its Series C Convertible Preferred Stock and Common Stock as of January 31, 2007. The valuation methodologies used in the retrospective valuation are consistent with the Practice Aid. The Company believes that the preparation of the retrospective valuation was necessary to allocate the proceeds from the Series C financing and the conversion of the convertible debt.

The retrospective valuation was prepared using the methodology discussed under Use of Estimates in Note 2.

The fair market value of the Company’s Series C Convertible Preferred Stock and Common Stock at January 31, 2007 is equal to the sum of the probability weighted present values for each scenario. The Company incorporated the fair values calculated in the retrospective valuation into the Black-Scholes option pricing model when calculating the fair value of the Series C Warrants and Common Stock Warrants. The retrospective valuation generated per share fair values of the Company’s Series C-1 Convertible Preferred Stock, Series C-2 Convertible Preferred Stock, Series C-3 Convertible Preferred Stock and Common Stock of $10.10, $10.20, $10.53 and $7.13, respectively.

The fair value of the Series C Warrants and the Common Stock Warrants was determined using the Black-Scholes option pricing model with a volatility factor of 65.0%, a risk free interest rate of 4.94%, no dividend yield and a contractual term of 5.67 years. Based on the relative fair values of the Series C Convertible Preferred Stock, Series C Warrants and Common Stock Warrants, approximately $97.7 million of the gross proceeds from the Series C financing and conversion of convertible debt were allocated to the Series C Convertible Preferred Stock, approximately $2.7 million was allocated to the Series C Warrants and approximately $110,300 was allocated to the Common Stock Warrants.

In accordance with EITF 98-5 and EITF 00-27, the Company recorded approximately $4.4 million of the proceeds allocated to the Series C Convertible Preferred Stock as a beneficial conversion feature with a corresponding credit recorded as additional paid-in capital. The beneficial conversion feature is analogous to a dividend and is being recognized as a return to the holders of the Series C Convertible Preferred Stock over the minimum period from the date of issuance to the date of earliest conversion. As the Series C Convertible Preferred Stock is convertible at the date of issuance, the beneficial conversion feature was fully amortized through additional paid-in capital at the date of issuance.

The Convertible Preferred Stock has the following characteristics:

Liquidation

Liquidation preferences for the Convertible Preferred Stock are as follows:

 

   

First, the holders of shares of Series C-3 Convertible Preferred Stock and Series C-2 Convertible Preferred Stock shall be paid, on a pari passu basis, an amount equal to the original issue price of $10.45157 per share (subject to adjustment), plus any declared and unpaid dividends thereon. However, if both of the milestones under the InterMune Asset Purchase Agreement have been achieved, the Series C-3 Convertible Preferred Stock and the Series C-2 Convertible Preferred Stock shall no longer rank on a pari passu basis upon a liquidation event and instead the Series C-3 Convertible Preferred Stock shall rank senior to the Series C-2 Convertible Preferred Stock such that the entire Series C-3 Convertible Preferred Stock liquidation preference shall be paid in full prior to any payment in respect of the Series

 

F-38


Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

13. Stockholders (deficit) equity (continued)

 

 

C-2 Convertible Preferred Stock. Further, if (as is presently the case) the Company has achieved one but not both of the InterMune milestones, the amount of the Series C-2 Convertible Preferred Stock liquidation preference that shall be pari passu to the Series C-3 Convertible Preferred Stock liquidation preference shall be proportionally adjusted. After payments to the holders of Series C-3 Convertible Preferred Stock and Series C-2 Convertible Preferred Stock are made, holders of the outstanding shares of Series C-1 Convertible Preferred Stock shall receive an amount per share equal to $10.45157 per share (subject to adjustment), plus any declared and unpaid dividends.

 

   

After payments are made to the holders of the Series C Convertible Preferred Stock as set forth above, the holders of the outstanding shares of Series B Convertible Preferred Stock shall receive an amount per share equal to $199.50 per share (subject to adjustment), plus accrued and unpaid dividends.

 

   

After payments are made to the holders of the Series C Convertible Preferred Stock and Series B Convertible Preferred Stock as set forth above, holders of all the outstanding shares of the Company’s Series C Convertible Preferred Stock, Series B Convertible Preferred Stock, Series A Convertible Preferred Stock and Common Stock shall share in the balance of any proceeds remaining for distribution on a pro rata, as-if-exchanged and as-if-converted to Common Stock basis.

Voting

Except where a separate class vote is otherwise required, the holders of Series C Convertible Preferred Stock, Series C Special Voting Stock, Series B Convertible Preferred Stock, Series B Special Voting Stock, Series A Convertible Preferred Stock, Series A Special Voting Stock, Common Stock and Common Special Voting Stock shall vote together as a single class on an as-if converted basis. Where a separate class vote of the shares of Series C Convertible Preferred Stock is required, the holders of shares of Series C Convertible Preferred Stock shall vote together with the holders of shares of Series C Special Voting Stock.

Dividends

The holders of Series C Convertible Preferred Stock and Series B Convertible Preferred Stock, on a pari passu basis, are entitled to receive dividends prior and in preference to any declaration or payment of any dividend on any other shares of any series or classes of stock of the Company other than the Series C Convertible Preferred Stock or the Series B Convertible Preferred Stock, at the rate of 8% per annum of the respective original issue price per share, payable when and if declared by the Board of Directors. Dividends on the Series C Convertible Preferred Stock and Series B Convertible Preferred Stock are not cumulative. The holders of Series A Convertible Preferred Stock are entitled to receive dividends when and if declared by the Board of Directors. As of March 31, 2007, no dividends have been declared for the Series A Convertible Preferred Stock, Series B Convertible Preferred Stock or Series C Convertible Preferred Stock other than dividends already declared and paid in shares of the Company’s capital stock (see Note 12).

The Company shall neither declare nor pay dividends on the Convertible Preferred Stock unless the holders of at least a majority of the then outstanding shares of Series C-3 Convertible Preferred Stock (on an as-if exchanged basis) have approved such declaration or payment. Further, for as long as any amount is due under the IQ Loan Facility (see Note 10), the payment of any declared but unpaid dividend on the Series C Convertible Preferred Stock and Series B Convertible Preferred Stock shall be satisfied only by the issuance of shares of the applicable series of Convertible Preferred Stock.

 

F-39


Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

13. Stockholders (deficit) equity (continued)

 

Conversion

 

   

Each share of Series A Convertible Preferred Stock, Series B Convertible Preferred Stock and Series C Convertible Preferred Stock is convertible, at the option of the holder, at any time after the date of issuance of such share into such number of shares of Common Stock as is determined by dividing (a) the sum of the original issue price in effect for such series and any declared but unpaid dividends on each share by (b) the conversion price then in effect for such series.

 

   

The original issue prices of the Series A Convertible Preferred Stock, Series B Convertible Preferred Stock and Series C Convertible Preferred Stock are $123.00, $199.50 and $10.45157 per share, respectively. The conversion prices of the Series A Convertible Preferred Stock, Series B Convertible Preferred Stock and Series C Convertible Preferred Stock, subject to certain adjustments, are $10.80, $19.35 and $10.45157 per share, respectively. As a result, presently, each share of Series A Convertible Preferred Stock is convertible into 11.389 shares of Common Stock; each share of Series B Convertible Preferred Stock is convertible into 10.310 shares of Common Stock; and each share of Series C Convertible Preferred Stock is convertible into one share of Common Stock.

 

   

Upon the closing of an initial public offering that is acceptable to the holders of at least a majority of the outstanding Series C-3 Convertible Preferred Stock and Series C-3 Special Voting Stock, voting together as a single class, each share of Series A Convertible Preferred Stock, Series B Convertible Preferred Stock and Series C Convertible Preferred Stock shall automatically be converted into such number of shares of Common Stock as determined by dividing (a) the sum of the original issue price in effect for such series and any declared but unpaid dividends on such share by (b) the conversion price in effect for such series on the date of the initial public offering.

Common stock

Common Stock, on an as-if exchanged basis, consists of the following:

 

     December 31,    March 31,
2007
     2005    2006   
               (unaudited)

Common Stock, par value $0.0001; 433,333 and 555,333 shares authorized at December 31, 2005 and 2006, respectively; 20,230 shares issued and outstanding, net of issuance costs

   $ 2    $ 2    $ 2

In December 2005, the Company incurred stock issuance costs related to the reorganization of which $108,880 was related to the Common Stock. Additionally, as a result of the reorganization in December 2005, the Company allocated approximately $2,644,000 from the value of the Common Stock to additional paid-in capital to reflect the par value of the Common Stock.

Each share of Common Stock is entitled to one vote. The holders of Common Stock are also entitled to receive dividends whenever funds are legally available and when declared by the Board of Directors, subject to the prior rights of holders of all classes of stock outstanding. The Company shall neither declare nor pay dividends on Common Stock unless the holders of at least 60% of the then outstanding shares of Series B Redeemable Convertible Preferred Stock (on an as-if exchanged basis) have approved such declaration or payment.

 

F-40


Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

13. Stockholders (deficit) equity (continued)

 

Effective upon the Company’s filing of its Second Amended and Restated Certificate of Incorporation on January 31, 2007, each share of Common Stock is entitled to one vote and the holders of Common Stock are also entitled to receive dividends whenever funds are legally available and when declared by the Board of Directors, subject to the prior rights of holders of all classes of stock outstanding. The Company shall neither declare nor pay dividends on Common Stock unless the holders of at least a majority of the then outstanding shares of Series C-3 Convertible Preferred Stock (on an as-if exchanged basis) have approved such declaration or payment.

The Company has reserved the following shares of Common Stock as of December 31, 2006 and March 31, 2007 for the potential conversion of outstanding Convertible Preferred Stock, convertible debt and the exercise of stock options and warrants:

 

     December 31,
2006
   March 31,
2007
          (unaudited)

Convertible Preferred Stock

   156,387    11,437,520

Warrants for the purchase of Series B Redeemable Convertible Preferred Stock

   6,837    —  

Warrants for the purchase of Series B Convertible Preferred Stock

   —      84,542

Warrants for the purchase of Series C-1 Convertible Preferred Stock

   —      484,354

Warrants for the purchase of Common Stock

   —      29,855

Convertible debt

   226,649    —  

Common Stock issuable upon exercise of stock options

   52,006    2,050,422
         
   441,879    14,086,693
         

14. Stock option plans

On January 28, 2003, Targanta Québec adopted the Re-Amended and Restated Stock Option Plan of Targanta Québec (“ Targanta Québec Plan ”) for the benefit of directors, senior officers, employees, consultants and for persons working on research projects of interest to Targanta Québec. The Targanta Québec Plan, as amended on July 13, 2006 and August 28, 2006, limits the time available to grant options under the Targanta Québec Plan to any time up to and including December 22, 2005. Options outstanding under the Targanta Québec Plan remain in effect in accordance with the terms of grant until they have been exercised, have expired, have been properly surrendered or have been terminated. All options outstanding under the Targanta Québec Plan were amended to become options to purchase Common Exchangeable Shares of Targanta Québec.

On December 23, 2005, the Company adopted its 2005 Stock Option Plan which was then amended on August 28, 2006, January 31, 2007 and March 27, 2007 to increase the number of shares of Common Stock available for issuance and to make certain clarifying amendments. The 2005 Stock Option Plan was intended to replace the Targanta Québec Plan. At December 31, 2006, the 2005 Stock Option Plan provided for the grant of options for the purchase of 39,372 shares of Common Stock plus any shares of Common Stock covered by outstanding options under the Targanta Québec Plan that are forfeited and returned for reissuance under the Targanta Québec Plan, such number not to exceed 13,960 shares of Common Stock, for an aggregate number of shares of Common Stock available for issuance under the 2005 Stock Option Plan of 53,333. At March 31, 2007, the 2005 Stock Option Plan provides for the grant of options for the purchase of 2,038,188 shares of Common Stock plus any shares of Common Stock covered by outstanding options under the Targanta Québec Plan that are

 

F-41


Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

14. Stock option plans (continued)

 

forfeited and returned for reissuance under the Targanta Québec Plan, such number not to exceed 13,561 shares of Common Stock, for an aggregate number of shares of Common Stock available for issuance under the 2005 Stock Option Plan of 2,051,749. Options may be granted, at the discretion of the Board of Directors, to employees, non-employee directors, consultants and service providers to the Company or any of its subsidiaries. Option exercise prices are the fair market value of the Common Stock on the date of grant. If there is no public trading market for the Company’s Common Stock, the fair value of the Common Stock on the date of grant is determined by the Board of Directors.

No option may be granted under the 2005 Stock Option Plan to any person who owns, directly or indirectly stock possessing more than 10% of the total combined voting power of all classes of stock of the Company or of any entity owning at least a majority of the voting stock of the Company, if any, or any of its subsidiaries, unless the option price of the shares subject to such option is fixed at not less than 110% of the fair market value on the date of grant of such shares and no options may be granted to any person in any one taxable year of the Company in excess of 25% of the options issued or issuable under the 2005 Stock Option Plan. The options are exercisable over a ten-year period from the date of grant or such lesser period of time as the Board of Directors may approve. The options vest over a period of one to five years or such lesser period of time as the Board of Directors may approve.

At December 31, 2006 and March 31, 2007, 5,989 and 2,004,405 shares, respectively, of Common Stock were available for future grant under the 2005 Stock Option Plan.

As discussed in Note 2, the Company adopted SFAS No. 123(R) effective January 1, 2006. In connection with the adoption of SFAS No. 123(R), the Company reassessed the valuation methodology for stock options and the related input assumptions. The assessment of the valuation methodology resulted in the continued use of the Black-Scholes model and the use of comparable companies’ data to estimate volatility and expected option term. Prior to the adoption of SFAS No. 123(R) the Company used a biotechnology industry index to estimate the expected volatility of the Company’s stock and used the contractual term of the grants for the expected option term in the absence of any historical data. For the year ended December 31, 2006 and the three months ended March 31, 2007, the risk-free interest rate for periods within the contractual life of the option was based on the United States Treasury yield curve in effect at the time of grant while for seven months ended December 31, 2005 and the years ended May 31, 2004 and 2005 the risk free interest rate was based on the Bank of Canada rate for a 10 year bond.

The following table summarizes the weighted-average assumptions the Company used in its fair value calculations at the date of grant:

 

     Year Ended
May 31,
2004
   Year Ended
May 31,
2005
   Seven Months
Ended
December 31,
2005
   Year Ended
December 31,
2006
   Three Months
Ended
March 31,
2007
                         (unaudited)

Risk-free interest rate

   4.50%    4.25%    3.94%    4.68%    4.57%

Expected dividend yield

   None    None    None    None    None

Expected option term

   10 years    10 years    10 years    5.3 years    5.4 years

Volatility

   35.9%    35.0%    33.8%    67.2%    64.1%

 

F-42


Table of Contents

Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

14. Stock option plans (continued)

 

SFAS No. 123(R) requires the application of an estimated forfeiture rate to current period expense to recognize compensation expense only for those awards expected to vest. The Company estimates forfeitures based upon comparable companies’ data and will adjust its estimate of forfeitures if actual forfeitures differ, or are expected to differ from such estimates. Subsequent changes in estimated forfeitures will be recognized through a cumulative catch-up adjustment in the period of change and will also impact the amount of stock-based compensation expense in future periods.

The weighted average fair value of each option granted during the years ended May 31, 2004 and 2005, the seven months ended December 31, 2005 and the year ended December 31, 2006 was $23.46, $25.00, $25.10 and $1.50, respectively, based on the assumptions in the Black-Scholes valuation model discussed above. There were no stock options granted in the three months ended March 31, 2007. For the years ended May 31, 2004 and 2005, the seven months ended December 31, 2005, the year ended December 31, 2006, the three months ended March 31, 2006 and 2007, and for the period from May 20, 1997 (date of inception) to March 31, 2007, the total stock-based compensation expense in connection with stock options issued and outstanding amounted to $315,407, $346,682, $199,038, $347,525, $83,436, $19,512 and $1,460,544, respectively. As of December 31, 2006 and March 31, 2007, there was $156,415 and $138,129, respectively, of unrecognized stock-based compensation costs. These costs are expected to be recognized over a weighted average period of 2.6 years and 2.4 years at December 31, 2006 and March 31, 2007, respectively.

The following table summarizes the combined activity of the Company’s stock options plans for the year ended December 31, 2006 and three months ended March 31, 2007:

 

     Shares of
Common Stock
Attributable to
Options
    Weighted
Average
Exercise
Price of
Options
  

Weighted
Average
Remaining
Contractual
Term

(in years)

  

Aggregate

Intrinsic
Value

Outstanding January 1, 2006

   13,789     $ 41.10      

Granted

   32,845       54.81      

Exercised

   —         —        

Cancelled

   (617 )     37.51      
              

Outstanding at December 31, 2006

   46,017       50.94    8.72      —  

Granted (unaudited)

   —         —        

Exercised (unaudited)

   —         —        

Cancelled (unaudited)

   —         —        
                        

Outstanding at March 31, 2007 (unaudited)

   46,017     $ 50.94    8.48    $ —  
                        

Vested or expected to vest at December 31, 2006

   43,290     $ 51.05    8.75    $ —  
                        

Vested or expected to vest at March 31, 2007 (unaudited)

   43,290     $ 51.05    8.50    $ —  
                        

Exercisable at December 31, 2006

   13,744     $ 42.76    7.18    $ —  
                        

Exercisable at March 31, 2007 (unaudited)

   18,168     $ 43.45    7.39    $ —  
                        

The intrinsic value of options exercised during the years ended May 31, 2004 and 2005 was $0. No options were exercised in the seven months ended December 31, 2005, the year ended December 31, 2006 and the three months ended March 31, 2007.

 

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Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

15. Income taxes

 

Since the Company has incurred net losses since inception, no provision for income taxes has been recorded except for the Part VI. I income tax and recovery of Canadian federal and provincial investment tax credits. Tax credits are treated as a reduction of income tax expense in the year in which they become recoverable (see Note 16). At December 31, 2006, the Company had United States federal and state net operating loss carryforwards of approximately $10,332,000 and Canadian federal and provincial net operating loss carryforwards of approximately $13,632,000 and $8,950,000, respectively, which expire at various dates beginning in 2007 through 2026.

The Company has Canadian research and development expenditures of approximately $10,881,000 which have not been deducted for Canadian federal income tax purposes and approximately $20,805,000 for Canadian provincial tax purposes. These expenditures are available to reduce future taxable income and have an unlimited carryforward period.

Additionally, the Company has non-refundable United States federal and state research and development tax credits of approximately $607,000 and Canadian research and development tax credits of approximately $1,398,000, which expire at various dates beginning in 2007 through 2026.

Components of the deferred tax asset and deferred tax liability are approximately as follows:

 

     December 31,  
     2005     2006  

Short-term deferred tax liabilities:

    

Part VI.I income tax

   $ —       $ (2,212,530 )
                

Total short-term deferred tax liabilities

     —         (2,212,530 )

Long-term deferred tax liabilities:

    

Part VI.I income tax

     (1,418,409 )     —    

Investment tax credits

     (439,240 )     (502,616 )

Financing and share issue costs and others

     (109,790 )     (25,408 )
                

Total long-term deferred tax liabilities

     (1,967,439 )     (528,024 )

Long-term deferred tax assets:

    

Net operating loss carryforwards

     3,426,090       7,993,737  

Scientific research and experimental development expenses

     4,261,102       4,759,230  

Property, equipment and intangible assets

     4,919,669       4,908,980  

Scientific research and experimental development tax credits

     962,482       2,220,138  

Financing and share issue costs

     —         126,503  
                

Total long-term deferred tax assets

     13,569,343       20,008,588  
                

Valuation allowance

     (13,020,313 )     (19,480,564 )
                

Net deferred tax liabilities

   $ (1,418,409 )   $ (2,212,530 )
                

Management of the Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets. Management has considered the Company’s history of operating losses and concluded, in accordance with the applicable accounting standards, that it is more likely than not that the Company may not realize the benefit of its deferred tax assets. Accordingly, the deferred tax assets have been fully reserved. Management reevaluates the positive and negative evidence on an annual basis. The net change in the total valuation allowance for the seven months ended December 31, 2005 and the year ended December 31, 2006 was an increase of $6,393,836 and $6,460,251, respectively.

 

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Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

15. Income taxes (continued)

 

The Tax Reform Act of 1986 limits the annual utilization of net operating loss and tax credit carryforwards, following an ownership change of the Company. Should the Company undergo such an ownership change, utilization of its carryforwards may be limited. Due to the reorganization that took place on December 23, 2005, the Company’s subsidiary, Targanta Québec, has undergone an acquisition of control for Canadian tax purposes that restricts its ability to utilize unclaimed loss carryforwards, scientific research and development expenditures and investment tax credit carryforwards. In addition, the acquisition of control resulted in an advancement by one year in the date of expiry of all tax loss carryforwards and investment tax credits.

The components of loss before income tax benefit are as follows:

 

      

Year Ended

May 31,
2004

    Year Ended
May 31,
2005
    Seven Months
Ended
December 31,
2005
    Year Ended
December 31,
2006
 

Loss before income tax (expense) benefit:

        

United States 

   $ —       $ —       $ (12,536,155 )   $ (14,686,386 )

Canada

     (6,620,337 )     (6,023,909 )     (4,543,386 )     (15,024,089 )
                                

Total loss before income tax (expense) benefit

     (6,620,337 )     (6,023,909 )     (17,079,541 )     (29,710,475 )

Income tax (expense) benefit:

        

United States

     —         —         —         —    

Canada

     776,167       758,752       1,490,656       (430,684 )
                                

Total income tax (expense) benefit

     776,167       758,752       1,490,656       (430,684 )
                                

Net loss

   $ (5,844,170 )   $ (5,265,157 )   $ (15,588,885 )   $ (30,141,159 )
                                

A reconciliation of the expected income tax (benefit) computed using the federal statutory income tax rate to the Company’s effective income tax rate is as follows:

 

     Year Ended
May 31, 2004
    Year Ended
May 31, 2005
    Seven
Months
Ended
December 31,
2005
    Year Ended
December 31,
2006
 

Income tax computed at federal statutory rate

   (32.19 )%   (31.02 )%   (34.00 )%   (34.00 )%

State income taxes, net of federal benefit

   —   %   —   %   (5.94 )%   (5.94 )%

Impact of change in promulgated rates

   —   %   —   %   (4.05 )%   0.73 %

Effect of foreign tax rates differential

   —   %   —   %   2.21 %   3.04 %

Non-deductible items

   1.60 %   2.80 %   1.85 %   15.65 %

Foreign exchange rate differential

   0.26 %   (5.25 )%   (2.98 )%   0.21 %

Research and development tax credits

   (22.91 )%   (22.64 )%   (5.94 )%   (1.29 )%

Unrecognized tax benefits of loss carryforwards and other differences

   29.65 %   35.19 %   43.09 %   18.83 %

Loss carryforwards expired and others

   0.68 %   (1.72 )%   (0.18 )%   1.48 %

Part VI. I income tax

   11.19 %   10.04 %   (2.79 )%   2.74 %
                        

Effective tax rate

   (11.72 )%   (12.60 )%   (8.73 )%   1.45 %
                        

16. Investment tax credits and government assistance

The Company incurred research and development expenditures which are eligible for Canadian federal and provincial refundable investment tax credits. The investment tax credits are recorded as income tax recovery, amounting to $1,516,873 and $1,363,724 for the years ended May 31, 2004 and 2005, respectively, $1,014,803 for the seven months ended December 31, 2005, $384,480 for the year ended December 31, 2006, $105,365 and $72,678 for the three months ended March 31, 2006 and 2007, respectively, and $7,665,175 for the period from May 20, 1997 (date of inception) to March 31, 2007. These amounts are based on management’s estimates of amounts expected to be recovered and are subject to audit by taxation authorities.

 

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Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

16. Investment tax credits and government assistance (continued)

 

In addition, the Company received Canadian government assistance in the amount of $66,745 and $123,277 for the years ended May 31, 2004 and 2005, respectively, $58,577 for the seven months ended December 31, 2005, $48,060 for the year ended December 31, 2006, $25,985 and $0 for the three months ended March 31, 2006 and 2007, respectively, and $717,556 for the period from May 20, 1997 (date of inception) to March 31, 2007. These amounts have been recorded as a reduction of research and development expenses.

17. Related-party transactions

In November 1997, the Company entered into consulting agreements with its founders. The agreements were amended in December 1999, February 2000, April 2002 and March 2004. The agreements required the Company to pay CAN$60,000 per year for scientific services. These agreements ended in June 2007. The Company recorded research and development expenses in the amount of $65,237 and $79,524, for the years ended May 31, 2004 and 2005, $23,222 for the seven months ended December 31, 2005, $0 and $51,212 for the three months ended March 31, 2006 and 2007 and $582,347 for the period from May 20, 1997 (date of inception) to March 31, 2007, in connection with the agreements.

18. Seven-month period ended December 31, 2004 (unaudited)

The Company changed its fiscal year end from May 31 to December 31 in 2005. Selected unaudited financial information for the seven-month period ended December 31, 2004 is as follows:

 

    

Seven Months Ended

December 31,

2004

 

Operating expenses

  

Research and development

   $ 2,681,747  

General and administrative

     736,700  
        

Total operating expenses

     3,418,447  
        

Other income (expense)

  

Interest income

     49,572  

Interest expense

     (71,680 )
        

Other income (expense), net

     (22,108 )
        

Loss before income tax benefit

     (3,440,555 )

Income tax benefit

     464,167  
        

Net loss

   $ (2,976,388 )
        

Net loss per share—basic and diluted

   $ (164.85 )
        

Weighted average number of common shares used in net loss per share—basic and diluted

     20,213  

19. Subsequent events

A. May 8, 2007 Equity Grants

On May 8, 2007, the Compensation Committee of the Company’s Board of Directors granted options to the Company’s officers and employees and certain non-employee directors to purchase a total of 1,771,850 shares of

 

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Targanta Therapeutics Corporation

(A development-stage company)

Notes to Consolidated Financial Statements—(continued)

(Including data applicable to unaudited periods)

19. Subsequent events (continued)

 

the Company’s Common Stock at an exercise price of $5.00 per share. This grant consisted of new awards for a total of 1,729,715 shares of Common Stock and replacement awards for a total of 42,135 shares of Common Stock. All of these options were granted pursuant to the terms and conditions of the Company’s 2005 Stock Option Plan. These options generally vest quarterly over four years, subject to acceleration of all unvested options if the employment of the option holder is terminated for any reason in the two years following a change of control. In the case of certain long-time employees, both new and replacement option grants vest quarterly in arrears over four years with an initial vesting date of April 1, 2006. A total of 42,135 options to purchase shares of the Company’s Common Stock with exercise prices that ranged from $36.00 to $70.50 will be cancelled upon acceptance of the replacement options.

For those replacement options where the Company has granted a new option in exchange for the cancellation of the old option, the Company will apply the guidance included in SFAS No. 123(R) for a modification of the terms of the cancelled option. The Company will measure the incremental compensation cost as the excess of the fair value of the replacement award over the fair value of the cancelled award at the cancellation date in accordance with paragraph 51 of SFAS No. 123(R). The total compensation cost measured at the date of the cancellation and replacement shall be the portion of the grant-date fair value of the original award for which the requisite service is expected to be rendered at that date plus the incremental cost resulting from the cancellation and replacement.

As such, the Company expects to record approximately $213,000 of stock-based compensation expense over the remaining service period of the replacement awards. The new awards will be accounted for under SFAS No. 123(R). The Company expects to record approximately $4.8 million in stock-based compensation over the service period of the new awards using the Black-Scholes option-pricing model with the following assumptions: fair value of Common Stock of $4.89, volatility factor of 64.1%, an expected term of 5.4 years, a weighted average risk-free interest rate of 4.50% and no dividend yield.

B. May 15, 2007 Equity Grant (unaudited)

On May 15, 2007, the Board of Directors granted an option to a non-employee director to purchase a total of 25,000 shares of the Company’s Common Stock at an exercise price of $5.00 per share. This option was granted pursuant to the terms and conditions of the Company’s 2005 Stock Option Plan. This grant will vest ratably in four equal installments on the date of the grant and each of the first three anniversaries of the grant date.

C. Facility Leases (unaudited)

In May 2007, the Company entered into a non-cancelable operating lease for 11,533 square feet of office space in Indianapolis, Indiana, which lease commences on June 1, 2007 and expires on August 31, 2010. The lease agreement provides for free rent for the first three months of the lease term and also has escalating rent payments over the life of the lease. Upon commencement of the lease, the Company will record a deferred rent liability related to the free rent and escalating rent payments. The Company will record the rent expense for the lease on a straight-line basis. Additionally, in May 2007, the landlord paid $30,000 for tenant improvements on behalf of the Company. The Company has recorded the tenant improvements as a lease incentive obligation and will amortize this amount as a reduction of rent expense over the life of the lease.

In May 2007, the Company amended the lease for its Cambridge, MA facility to expand the rentable square feet by 1,471 and extend the term through October 2009, with two one-year renewal options. The amended lease has escalating rent payments over the life of the lease. The Company will record the rent expense for the lease on a straight-line basis.

 

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LOGO

 


Table of Contents

PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

Item 13. Other Expenses of Issuance and Distribution.

The following table sets forth the costs and expenses, other than the underwriting discount, payable by us in connection with the sale of common stock being registered. All amounts are estimated except the SEC registration fee, the NASD filing fees and The Nasdaq Global Market Listing Fee.

 

     Amount To
Be Paid

SEC registration fee

   $ 2,647.88

NASD filing fee

     9,125.00

Nasdaq Global Market listing fee

     *

Printing and mailing expenses

     *

Legal fees and expenses

     *

Accounting fees and expenses

     *

Transfer agent and registrar fees and expenses

     *

Miscellaneous

     *

Total

   $ *

*     to be filed by amendment.

Item 14. Indemnification of Directors and Officers.

Section 145(a) of the Delaware General Corporation Law provides, in general, that a corporation may indemnify any person who was or is a party or is 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), because he or she is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by the person in connection with such action, suit or proceeding, if he or she acted in good faith and in a manner he or she 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.

Section 145(b) of the Delaware General Corporation Law provides, in general, that a corporation may indemnify any person who was or is a party or is 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 because the person is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, against expenses (including attorneys’ fees) actually and reasonably incurred by the person in connection with the defense or settlement of such action or suit if he or she acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the best interests of the corporation, except that no indemnification shall be made with respect to any claim, issue or matter as to which he or she shall have been adjudged to be liable to the corporation unless and only to the extent that the Court of Chancery or other adjudicating court determines that, despite the adjudication of liability but in view of all of the circumstances of the case, he or she is fairly and reasonably entitled to indemnity for such expenses which the Court of Chancery or other adjudicating court shall deem proper.

Section 145(g) of the Delaware General Corporation Law provides, in general, that a corporation may purchase and maintain insurance on behalf of any person who is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise against any liability asserted against such

 

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person and incurred by such person in any such capacity, or arising out of his or her status as such, whether or not the corporation would have the power to indemnify the person against such liability under Section 145 of the Delaware General Corporation Law.

Article VII of our Third Amended and Restated Certificate of Incorporation, as will be in effect at the time of this offering (the “ Charter ”), will provide that no director of our company shall be personally liable to us or our stockholders for monetary damages for any breach of fiduciary duty as a director, except for liability (1) for any breach of the director’s duty of loyalty to us or our stockholders, (2) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law, (3) in respect of unlawful dividend payments or stock redemptions or repurchases, or (4) for any transaction from which the director derived an improper personal benefit. In addition, our Charter provides that if the Delaware General Corporation Law is amended to authorize the further elimination or limitation of the liability of directors, then the liability of a director of our company shall be eliminated or limited to the fullest extent permitted by the Delaware General Corporation Law, as so amended.

Article VII of the Charter will further provide that any repeal or modification of such article by our stockholders or an amendment to the Delaware General Corporation Law will not adversely affect any right or protection existing at the time of such repeal or modification with respect to any acts or omissions occurring before such repeal or modification of a director serving at the time of such repeal or modification.

Article V of our Amended and Restated By-Laws, as will be in effect at the time of this offering (the “ By-Laws ”), will provide that we will indemnify each of our directors and officers and, in the discretion of our board of directors, certain employees, to the fullest extent permitted by the Delaware General Corporation Law as the same may be amended (except that in the case of an amendment, only to the extent that the amendment permits us to provide broader indemnification rights than the Delaware General Corporation Law permitted us to provide prior to such the amendment) against any and all expenses, judgments, penalties, fines and amounts reasonably paid in settlement that are incurred by the director, officer or such employee or on the director’s, officer’s or employee’s behalf in connection with any threatened, pending or completed proceeding or any claim, issue or matter therein, to which he or she is or is threatened to be made a party because he or she is or was serving as a director, officer or employee of our company, or at our request as a director, partner, trustee, officer, employee or agent of another corporation, partnership, joint venture, trust, employee benefit plan or other enterprise, if he or she acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the best interests of our company and, with respect to any criminal proceeding, had no reasonable cause to believe his or her conduct was unlawful, provided however, with respect to actions, suits and proceedings other than by or in the right of our company, that no indemnification shall be made under in respect of any claim, issue or matter as to which he or she has been finally adjudged by a court of competent jurisdiction to be liable to our company, unless, and only to the extent that, the Delaware Court of Chancery or another court in which such proceeding was brought has determined upon application that, despite adjudication of liability, but in view of all the circumstances of the case, he or she is fairly and reasonably entitled to indemnification for such expenses that such court deem proper. Article V of the By-Laws further provides for the advancement of expenses to each of our directors and, in the discretion of the board of directors, to certain officers and employees.

In addition, Article V of the By-Laws will provide that the right of each of our directors and officers to indemnification and advancement of expenses shall be a contract right and shall not be exclusive of any other right now possessed or hereafter acquired under any statute, provision of the Charter or By-Laws, agreement, vote of stockholders or otherwise. Furthermore, Article V of the By-Laws will authorize us to provide insurance for our directors, officers and employees, against any liability, whether or not we would have the power to indemnify such person against such liability under the Delaware General Corporation Law or the provisions of Article V of the By-Laws.

We have entered into indemnification agreements with each of our directors and executive officers. These agreements provide that we will indemnify each of our directors and executive officers, and other entities to the fullest extent permitted by law.

 

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We also maintain a general liability insurance policy which covers certain liabilities of directors and officers of our company arising out of claims based on acts or omissions in their capacities as directors or officers.

In any underwriting agreement we enter into in connection with the sale of common stock being registered hereby, the underwriters will agree to indemnify, under certain conditions, us, our directors, our officers and persons who control us within the meaning of the Securities Act of 1933, as amended, against certain liabilities.

Item 15. Recent Sales of Unregistered Securities

Since May 1, 2004, we have or, in the case of the period prior to our inception in December 2005, our Québec subsidiary has issued and sold unregistered securities in connection with private placements of our securities and option issuances. These securities were deemed to be exempt from registration either pursuant to (a) Section 4(2) of the Securities Act and Regulation D promulgated thereunder, as transactions by an issuer not involving a public offering; (b) Rule 701 under the Securities Act, as transactions pursuant to a compensatory benefit plan approved by the registrant’s board of directors; (c) Regulation S promulgated under the Securities Act, as offers and sales of securities outside the United States; or (d) applicable Canadian Securities rules.

We issue shares of special voting stock to non-U.S. purchasers to correspond with issuances by our Québec and Ontario subsidiaries of exchangeable shares. Holders of exchangeable shares issued by our Canadian subsidiaries may elect, at any time, to exchange those shares for shares of the like class or series of our capital stock. Upon the effectiveness of our initial public offering, we will be redeeming all outstanding exchangeable shares issued by our Canadian subsidiaries in exchange for like shares of the corresponding class or series of our capital stock. In addition, all outstanding warrants to purchase exchangeable shares will be converted into warrants to purchase shares of the corresponding class or series of our capital stock. Upon the exchange of exchangeable shares issued by one of our Canadian subsidiaries for shares of the corresponding class or series of our capital stock, the shares of special voting stock that corresponded to those exchangeable shares are automatically cancelled.

Stock and Convertible Debt Issuances

On October 28, 2005, our Québec subsidiary issued and sold convertible notes with an aggregate principal amount of CAN$1,747,841 in a private placement to three United States investors and two non-U.S. purchasers, each of whom is an accredited investor under both applicable Canadian and United States definitions. The issuance of these securities met the conditions for the private issuer exemption under National Instrument 45-106 adopted by the Canadian Securities Administrators. Simultaneously, our Québec subsidiary issued to these purchasers warrants to purchase an aggregate of up to 5,600 Class A-2 preferred shares (which shares were, on December 23, 2005, reclassified as Class B preferred exchangeable shares). Further, on December 23, 2005, all of the warrants issued in this transaction (including those reissued by us in exchange for like securities originally issued by our Québec subsidiary in October 2005) were exercised in full (for an aggregate of 4,667 shares of our Series B preferred stock and 933 Class B preferred exchangeable shares of our Québec subsidiary) and, in a transaction exempt from registration pursuant to Regulation S, we issued 933 shares of our Series B special voting stock to the one remaining non-U.S. purchaser holding securities from this transaction issued by our Québec subsidiary.

On December 23, 2005, in connection with the formation of the company and the restructuring of the securities of our Québec subsidiary, in a transaction exempt from registration pursuant to Regulation S and without the payment of any additional consideration, we issued 15,643 shares of our Series A special voting stock to two non-U.S. investors, 47,006 shares of our Series B special voting stock to five non-U.S. investors and 20,230 shares of our common special voting stock to eighteen non-U.S. purchasers. Additionally, in a transaction pursuant to Section 4(2) of the Securities Act not involving a public offering, in exchange for like securities issued by our Québec subsidiary and without the payment of additional consideration, we issued 21,366 shares of our Series B preferred stock to two accredited investors and convertible promissory notes in the aggregate principal amount of CAN$1,456,591.15 to four accredited investors. On December 23, 2005, our Québec subsidiary also amended and restated a convertible note originally issued on October 24, 2005 in the principal amount of CAN$291,250.

 

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Additionally, on December 23, 2005, we issued and sold convertible notes with an aggregate principal value of $3,950,000 to six accredited investors in a private placement under Section 4(2) of the Securities Act. Simultaneously, we issued to these purchasers warrants to purchase an aggregate of up to 19,134 shares of our Series B preferred stock, which warrants were immediately exercised for that number of shares of our Series B preferred stock. In addition, our two Canadian subsidiaries issued and sold convertible notes to a total of three non-U.S. purchasers, each of whom is an accredited investor, with an aggregate principal value of $6,350,000. In addition, in connection with the issuance by our Québec and Ontario subsidiaries of warrants to purchase up to an aggregate of 29,880 Class B preferred exchangeable shares of these companies to four non-U.S. purchasers, which warrants were immediately exercised for that number of Class B preferred exchangeable shares of these companies, without the payment of additional consideration, we issued a like number of shares of our Series B special voting stock to these four non-U.S. purchasers in a transaction exempt from registration pursuant to Regulation S.

On December 7, 2006, we issued and sold convertible debentures with an aggregate principal value of $3,450,000 to three accredited investors in a private placement under Section 4(2) of the Securities Act. In addition, our Ontario subsidiary issued and sold convertible debentures to three non-U.S. purchasers, each of whom is an accredited investor, with an aggregate principal value of $8,378,000.

On December 19, 2006, we issued and sold additional convertible debentures with an aggregate principal value of $1,200,000 to two accredited investors in a private placement under Section 4(2) of the Securities Act. In addition, our Ontario subsidiary issued and sold an additional convertible debenture to an accredited non-U.S. purchaser with an aggregate principal value of $1,000,000.

All of the convertible notes and debentures described above were ultimately converted into equity securities in our January 31, 2007 financing.

On January 31, 2007, we issued and sold an aggregate of 1,635,970 shares of our Series C-1 preferred stock to eight accredited investors, 273,734 shares of our Series C-2 preferred stock to eight accredited investors and 4,818,508 shares of our Series C-3 preferred stock to eighteen accredited investors in a private placement under Section 4(2) of the Securities Act for aggregate consideration of $48,571,999.36 in cash and $21,748,379.42 in converted debt securities. We also issued warrants to purchase up to an aggregate of 333,345 shares of our Series C-1 preferred stock to twenty accredited investors in a private placement under Section 4(2) of the Securities Act. Further, we issued warrants to purchase up to an aggregate of 29,855 shares of our common stock to eighteen non-U.S. investors in a transaction exempt from registration pursuant to Regulation S.

Additionally, on January 31, 2007, in connection with the issuance by our Ontario subsidiary of an aggregate of 725,047 Class C-1 preferred exchangeable shares to three non-U.S. accredited investors, we issued those same investors a like number of shares of our Series C-1 special voting stock in a transaction exempt from registration under Regulation S. In connection with the issuance by our Ontario subsidiary of an aggregate of 448,640 Class C-2 preferred exchangeable shares to three accredited investors, we issued to those investors a like number of shares of our Series C-2 special voting stock in a transaction exempt from registration under Regulation S. In connection with the issuance by our Ontario subsidiary of an aggregate of 448,640 Class C-3 preferred exchangeable shares to three accredited investors, we issued to those investors a like number of shares of our Series C-3 special voting stock in a transaction exempt from registration under Regulation S. In connection with the foregoing issuances, our Ontario subsidiary received aggregate consideration of $16,955,864.17 in cash. On January 31, 2007, our Ontario subsidiary also issued warrants to purchase up to 80,378 Class C-1 exchangeable shares to three accredited investors and, upon exercise of these warrants, we will issue those investors up to 80,378 shares of our Series C-1 special voting stock.

On January 31, 2007, we issued a stock dividend, paid in the form of 8,550 additional shares of Series B preferred stock, to the holders of outstanding shares of our Series B preferred stock. In addition, in connection with the issuance by our Québec and Ontario subsidiaries of a similar stock dividend on the outstanding Class B preferred exchangeable shares of those companies, we issued 20,142 shares of our Series B special voting stock to the holders of outstanding shares of our Series B special voting stock in a transaction exempt under Regulation S.

 

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Table of Contents

On February 7, 2007, upon our achievement of a milestone and for no additional consideration, we issued 358,797 shares of our Series C-2 preferred stock, 358,798 shares of our Series C-3 preferred stock and a warrant to purchase up to 35,552 shares of our Series C-1 preferred stock to one accredited investor in a private placement under Section 4(2) of the Securities Act.

On February 16, 2007, we issued and sold an additional 708,828 shares of our Series C-3 preferred stock to nine accredited investors in a private placement under Section 4(2) of the Securities Act for aggregate consideration of $7,400,004.23. We also issued warrants to purchase up to an additional 35,079 shares of our Series C-1 preferred stock to these nine accredited investors.

Option Issuances

2005 Stock Option Plan . Pursuant to our 2005 Stock Option Plan, we have granted options to purchase a total of 1,800,616 (which presumes the cancellation of options to purchase an aggregate of 42,135 shares of our common stock in connection with a May 8, 2007 grant further described below) shares of our common stock to our employees, directors, officers and consultants with exercise prices ranging from $5.00 to $70.50. All of these options were issued pursuant to Rule 701 under the Securities Act as transactions pursuant to a compensatory benefit plan approved by the registrant’s board of directors. Some of these options have lapsed or otherwise expired and are no longer exercisable. The maximum number of shares of common stock that we may issue pursuant to our 2005 Stock Option Plan is 2,051,749. As of May 1, 2007, we had not issued any shares of common stock upon the exercise of stock options granted pursuant to our 2005 Stock Option Plan. In May 2007, we granted replacement and new options to purchase up to 1,771,850 shares of our common stock in part in exchange for the anticipated cancellation of 42,135 outstanding options and we granted an additional option to purchase 25,000 shares of our common stock to a new non-employee director.

Québec Option Plan. Our Québec subsidiary’s Stock Option Plan, or the Québec Option Plan, was adopted by the board of directors and approved by the shareholders of our Québec subsidiary in May 1998 and was amended and restated in January 2003, December 2005, and July 2006. Under the Québec Option Plan, the board of directors of the Québec subsidiary granted options exercisable for common shares (now re-classified as common exchangeable shares) of the Québec subsidiary to directors, senior officers, employees, consultants and persons working on research projects of interest to the Québec subsidiary. A total of 13,561 common exchangeable shares are issuable under the Québec Option Plan. No new options have been granted under the Québec Option Plan since the adoption of our 2005 Stock Option Plan in December 2005.

The board of directors of our Québec subsidiary administered the Québec Option Plan and selected those eligible to be granted options, established the price, the terms and conditions of each option including, the vesting provisions and had the power to adopt rules and regulations for carrying out the Québec Option Plan. The board of directors of our Québec subsidiary may at any time terminate, modify or amend the Québec Option Plan in its absolute discretion, except where regulatory approval is required.

Under the Québec Option Plan, the exercise price of all options was determined by the board of directors of the Québec subsidiary on the date of the grant. Additionally, the term of all options granted under the Québec Option Plan could not exceed ten years from the date of the grant.

Upon an optionholder ceasing to be an eligible person, any unvested options are forfeited. Vested options may be exercised for five years from the date the optionholder ceased to be an eligible person in the case of directors or consultants and, in other cases, 60 days from that date. If an optionholder is terminated without cause, all of his or her options become vested and remain exercisable until their expiry date.

The recipients of securities in each of the transactions summarized above represented their intention to acquire the securities for investment only and not with a view to or for sale in connection with any distribution thereof and appropriate legends were affixed to the share certificates and instruments issued in such transactions.

 

II-5


Table of Contents

All recipients either received adequate information about us or had adequate access, through their relationship with us, to information about us. There were no underwriters employed in connection with any of the transactions set forth in Item 15.

Item 16. Exhibits.

(a) See the Exhibit Index on the page immediately preceding the exhibits for a list of exhibits filed as part of this registration statement on Form S-1, which Exhibit Index is incorporated herein by reference.

(b) Financial Statement Schedules

None.

Item 17. Undertakings.

The undersigned registrant hereby undertakes to provide to the underwriter at the closing specified in the underwriting agreement, certificates in such denominations and registered in such names as required by the underwriter 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 of 1933, as amended, and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses 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 the 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 of 1933, as amended, 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, as amended, 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 of 1933, as amended, 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, as amended, 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.

 

II-6


Table of Contents

SIGNATURES

Pursuant to the requirements of the Securities Act of 1933, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the city of Cambridge, Commonwealth of Massachusetts on June 27, 2007.

 

T ARGANTA T HERAPEUTICS C ORPORATION

By:

 

/s/    George Eldridge

 

 

George Eldridge

 

Senior Vice President, Chief Financial Officer, Treasurer and Assistant Secretary

SIGNATURES AND POWER OF ATTORNEY

We, the undersigned directors and/or officers of Targanta Therapeutics Corporation (the “ Company ”), hereby severally constitute and appoint Mark Leuchtenberger and George Eldridge, and each of them singly, our true and lawful attorneys, with full power to any of them, and to each of them singly, to sign for us and in our names in the capacities indicated below the registration statement on Form S-1 filed herewith, and any and all pre-effective and post-effective amendments to said registration statement, and any registration statement filed pursuant to Rule 462(b) under the Securities Act of 1933, as amended, in connection with the registration under the Securities Act of 1933, as amended, of equity securities of the Company, and to file or cause to be filed the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as each of them might or could do in person, and hereby ratifying and confirming all that said attorneys, and each of them, or their substitute or substitutes, shall do or cause to be done by virtue of this Power of Attorney.

Pursuant to the requirements of the Securities Act of 1933, this registration statement has been signed by the following persons in the capacities indicated on June 27, 2007:

 

Signature

  

Title

*

 

Mark Leuchtenberger

  

President, Chief Executive Officer and Director (Principal Executive Officer)

/s/    George Eldridge        

 

George Eldridge

  

Senior Vice President, Chief Financial Officer, Treasurer and Assistant Secretary (Principal Financial and Accounting Officer)

/s/    Garen Bohlin        

 

Garen Bohlin

  

Director

*

 

Jeffrey Courtney

  

Director

*

 

William Crouse

  

Director

*

 

Eric Gordon

  

Director

*

 

Dilip Mehta

  

Director

 

II-7


Table of Contents

Signature

  

Title

*

 

Robin Steele

  

Director

*

 

Jay Venkatesan

  

Director

 

*By:

  /s/    George Eldridge        
 

George Eldridge

Attorney-in-fact

 

II-8


Table of Contents

EXHIBIT INDEX

 

Number   

Description

*      1.1   

Form of Underwriting Agreement

%      3.1   

Second Amended and Restated Certificate of Incorporation of the Registrant

*      3.2   

Form of Third Amended and Restated Certificate of Incorporation of the Registrant (to be effective upon the completion of this offering)

D      3.3   

By-laws of the Registrant

*      3.4   

Form of Amended and Restated By-laws of the Registrant (to be effective upon completion of this offering)

*      4.1   

Specimen Common Stock Certificate

%      4.2   

Amended and Restated Registration Rights Agreement, dated January 31, 2007, by and among the Registrant and certain stockholders of the Registrant

*      5.1   

Opinion of Choate, Hall & Stewart LLP

%†    10.1   

2005 Stock Option Plan, as amended

%†    10.1.1   

Form of Notice of Stock Option Grant

%†    10.1.2   

Form of Stock Option Agreement

%†    10.1.3   

Form of Notice of Stock Option Grant for Montreal employees

%†    10.1.4   

Form of Stock Option Agreement for Montreal employees

D    10.1.5   

Form of Stock Option Agreement as of May 2007

D    10.1.6   

Form of Stock Option Agreement for Montreal employees as of May 2007

*†    10.2   

2007 Equity Incentive Plan

*†    10.2.1   

Form of Incentive Stock Option Agreement under 2007 Equity Incentive Plan

*†    10.2.2   

Form of Non-Qualified Stock Option Agreement under 2007 Equity Incentive Plan

%†    10.3   

Employment Agreement, dated September 12, 2006, by and between the Registrant and Mark Leuchtenberger

%†    10.4   

Employment Agreement, dated September 25, 2006, by and between the Registrant and George Eldridge

D    10.5   

Employment Agreement, dated May 6, 2007, by and between the Registrant and Pierre Etienne, M.D.

D    10.6   

Employment Agreement, dated May 9, 2007, by and between the Registrant and Thomas Parr, Ph.D.

%    10.7   

Lease Agreement, dated October 20, 2006, by and between the Registrant and American Twine Limited Partnership

%    10.7.1   

First Amendment to Lease, dated May 4, 2007, by and between the Registrant and American Twine Limited Partnership

D    10.8   

Lease Agreement, dated April 18, 2002, by and between Targanta Therapeutics Inc. (f/k/a Phagetech Inc.), a subsidiary of the Registrant, and Société Immobilière Technologique de Montréal Inc.

D    10.9   

Lease Agreement, dated March 1, 2007, by and among the Registrant, United Family Life Insurance Company and United Farm Family Life Insurance Company

D #    10.10   

Manufacturing Services Agreement, dated March 27, 2007, by and between the Registrant and Catalent Pharma Solutions, Inc. (f/k/a Cardinal Health PTS, LLC)

D #    10.11   

License Agreement, dated December 23, 2005, by and between the Registrant (as successor to InterMune, Inc.) and Eli Lilly and Company


Table of Contents
Number   

Description

%    10.12   

Asset Purchase Agreement, dated December 23, 2005, by and between the Registrant and InterMune, Inc.

%    10.13   

Note Issuance Agreement, dated December 23, 2005, by and between the Registrant and InterMune, Inc.

%    10.14   

Senior Secured Convertible Acquisition Note, issued by the Registrant to InterMune, Inc. on December 23, 2005

%    10.15   

Omnibus Amendment, dated January 31, 2007, to Asset Purchase Agreement, Note Issuance Agreement and Senior Secured Convertible Acquisition Note, each dated December 23, 2005

D #    10.16   

Development and Supply Agreement, dated December 28, 2001, by and between InterMune, Inc., as predecessor in interest to the Registrant, and Abbott Laboratories

D #    10.16.1   

Amendment No. 1 to Development and Supply Agreement, dated April 26, 2002, by and between InterMune, Inc., as predecessor in interest to the Registrant, and Abbott Laboratories

D #    10.16.2   

Amendment No. 2 to Development and Supply Agreement, dated October 15, 2002, by and between InterMune, Inc., as predecessor in interest to the Registrant, and Abbott Laboratories

D    10.16.3   

Amendment No. 3 to Development and Supply Agreement, dated December 22, 2005, by and between InterMune, Inc., as predecessor in interest to the Registrant, and Abbott Laboratories

D #    10.16.4   

Amendment No. 4 to Development and Supply Agreement, dated December 15, 2006, by and between the Registrant and Abbott Laboratories

%†    10.17   

Form of Indemnification Agreement, by and between the Registrant and its executive officers and directors

%†    10.18   

Form of Employee Agreement re: Non-competition, Non-solicitation, Non-disclosure and Ownership of Inventions

%    10.19   

Form of Series C-1 Preferred Stock Warrant

%    10.20   

Form of Common Stock Warrant

*    10.21   

Offer of Loan, by and between Targanta Therapeutics Inc., a subsidiary of the registrant, and Investissement Québec, dated April 27, 2004

*    10.22   

General Movable Hypothec, by and between Targanta Therapeutics Inc., a subsidiary of the registrant, and Investissement Québec, dated April 30, 2004

*    10.23   

Amendment to Offer of Loan, by and between the Registrant, Targanta Therapeutics Inc., a subsidiary of the registrant, Targanta Therapeutics (Ontario) Inc., a subsidiary of the registrant, and Investissement Québec, dated December 22, 2005

*    10.24   

Amendment to Offer of Loan, by and between the Registrant, Targanta Therapeutics Inc., a subsidiary of the registrant, Targanta Therapeutics (Ontario) Inc., a subsidiary of the registrant, and Investissement Québec, dated January 30, 2007

%    21.1   

List of Subsidiaries

*    23.1   

Consent of Choate, Hall & Stewart LLP (included in Exhibit 5.1)

D    23.2   

Consent of Ernst & Young LLP

%    24.1   

Power of Attorney (included on Page II-7)


  Indicates a management contract or any compensatory plan, contract or arrangement.
*   To be filed by amendment.
D   Filed herewith.
%   Previously filed.
#   Confidential treatment requested for portions of this document.

Exhibit 3.3

BYLAWS

OF

TARGANTA THERAPEUTICS CORPORATION

(A Delaware Corporation)

 


BYLAWS

OF

TARGANTA THERAPEUTICS CORPORATION

(A Delaware Corporation)

TABLE OF CONTENTS

     Page

ARTICLE 1 CERTIFICATE OF INCORPORATION

   1

Section 1.1 Contents

   1

Section 1.2 Certificate in Effect

   1

ARTICLE 2 MEETINGS OF STOCKHOLDERS

   1

Section 2.1 Place

   1

Section 2.2 Annual Meeting

   1

Section 2.3 Special Meetings

   1

Section 2.4 Notice of Meetings; Business at Meetings

   2

Section 2.5 Affidavit of Notice

   2

Section 2.6 Quorum

   2

Section 2.7 Voting Requirements

   2

Section 2.8 Proxies and Voting

   3

Section 2.9 Action Without Meeting

   3

Section 2.10 Stockholder List

   3

Section 2.11 Record Date

   3

ARTICLE 3 DIRECTORS

   4

Section 3.1 Number; Election and Term of Office

   4

Section 3.2 Duties

   4

Section 3.3 Compensation

   4

Section 3.4 Reliance on Books

   5

Section 3.5 No Casting Vote

   5

ARTICLE 4 MEETINGS OF THE BOARD OF DIRECTORS

   5

Section 4.1 Place

   5

Section 4.2 Annual Meeting

   5

Section 4.3 Regular Meetings

   5

Section 4.4 Special Meetings

   5

Section 4.5 Notice of Meetings; Business at Meetings

   5

Section 4.6 Quorum

   6

Section 4.7 Action Without Meeting

   6

Section 4.8 Telephone Meetings

   6

 

i


     Page

Section 4.9 Presumption of Assent

   6

ARTICLE 5 COMMITTEES OF DIRECTORS

   7

Section 5.1 Designation.

   7

Section 5.2 Records of Meetings

   7

Section 5.3 Notice

   7

Section 5.4 Quorum

   7

ARTICLE 6 NOTICES

   8

Section 6.1 Method of Giving Notice

   8

Section 6.2 Waiver

   8

ARTICLE 7 OFFICERS

   9

Section 7.1 General

   9

Section 7.2 Election of President, Secretary and Treasurer

   9

Section 7.3 Election of Other Officers

   9

Section 7.4 Salaries

   9

Section 7.5 Term of Office

   9

Section 7.6 Duties of President and Chairman of the Board

   9

Section 7.7 Duties of Vice President

   9

Section 7.8 Duties of Secretary

   10

Section 7.9 Duties of Assistant Secretary

   10

Section 7.10 Duties of Treasurer

   10

Section 7.11 Duties of Assistant Treasurer

   10

ARTICLE 8 RESIGNATIONS, REMOVALS AND VACANCIES

   11

Section 8.1 Directors.

   11

Section 8.2 Officers

   11

ARTICLE 9 CERTIFICATE OF STOCK

   12

Section 9.1 Issuance of Stock

   12

Section 9.2 Right to Certificate, Form

   12

Section 9.3 Facsimile Signature

   12

Section 9.4 Lost Certificates

   12

Section 9.5 Transfer of Stock

   12

Section 9.6 Registered Stockholders

   12

ARTICLE 10 INDEMNIFICATION

   13

Section 10.1 General.

   13

Section 10.2 Advancement of Expenses

   14

Section 10.3 Indemnification Procedures.

   15

Section 10.4 Rights Not Exclusive

   16

Section 10.5 Subsequent Events.

   16

Section 10.6 Invalidation

   17

 

ii


     Page

Section 10.7 Definitions

   17

ARTICLE 11 EXECUTION OF PAPERS

   17

ARTICLE 12 FISCAL YEAR

   17

ARTICLE 13 SEAL

   17

ARTICLE 14 OFFICES

   18

ARTICLE 15 AMENDMENTS

   18

 

 

 

iii


TARGANTA THERAPEUTICS CORPORATION

BYLAWS

ARTICLE 1

CERTIFICATE OF INCORPORATION

Section 1.1 Contents . The name, location of principal office and purposes of the Corporation shall be as set forth in its Certificate of Incorporation. These Bylaws, the powers of the Corporation and of its Directors and stockholders, and all matters concerning the conduct and regulation of the business of the Corporation shall be subject to such provisions in regard thereto, if any, as are set forth in said Certificate of Incorporation. The Certificate of Incorporation is hereby made a part of these Bylaws.

Section 1.2 Certificate in Effect . All references in these Bylaws to the Certificate of Incorporation shall be construed to mean the Certificate of Incorporation of the Corporation as from time to time amended, including (unless the context shall otherwise require) all certificates and any agreement of consolidation or merger filed pursuant to the Delaware General Corporation Law, as amended.

ARTICLE 2

MEETINGS OF STOCKHOLDERS

Section 2.1 Place . All meetings of the stockholders may be held at such place either within or without the State of Delaware, or may be held by remote communication to the extent permitted by Delaware law, as shall be designated from time to time by the Board of Directors, the Chairman of the Board of Directors or the President and stated in the notice of the meeting or in any duly executed waiver of notice thereof.

Section 2.2 Annual Meeting . Annual meetings of stockholders, shall be held at 10:00 o’clock a.m. on the second Tuesday of February in each year, if not a legal holiday, and, if a legal holiday, then on the next secular day following, at 10:00 a.m., or at such other date and time as shall be designated from time to time by the Board of Directors, the Chairman of the Board of Directors or the President and stated in the notice of the meeting. If such annual meeting has not been held on the day herein provided therefor, a special meeting of the stockholders in lieu of the annual meeting may be held, and any business transacted or elections held at such special meeting shall have the same effect as if transacted or held at the annual meeting, and in such case all references in these Bylaws, except in this Section 2.2, to the annual meeting of the stockholders shall be deemed to refer to such special meeting.

Section 2.3 Special Meetings . Special meetings of the stockholders, for any purpose or purposes, unless otherwise prescribed by statute or by the Certificate of Incorporation, may be called by a majority of the Board of Directors acting by vote or by written instruments signed by


them. Special meeting of the stockholders shall be called by the President or Secretary at the request in writing of any two (2) Directors then in office, at the request in writing of any Investors (as such term is defined under the Unanimous Shareholders Agreement of the Corporation, dated as of December 22, 2005 (the “USA”)) or at the request in writing of stockholders owning at least ten percent (10%) in amount of the Common Stock on a Fully Diluted, Converted and Exchanged Basis (as such term is defined under the USA). Such request shall state the purpose or purposes of the proposed meeting, which need not be the exclusive purposes for which the meeting is called.

Section 2.4 Notice of Meetings; Business at Meetings . A written notice of all meetings of stockholders stating the place, date and hour of the meeting and, in the case of a special meeting, the purpose or purposes for which the special meeting is called, and be accompanied by material and other information reasonably available and required in order for stockholders to take an informed decision on the matter to be discussed at the meeting, and shall be given to each stockholder entitled to vote at such meeting. Except as otherwise provided by law, such notice shall be given not less than five nor more than sixty days before the date of the meeting. Business transacted at any meeting of stockholders shall be limited to the purposes stated in the notice, unless otherwise permitted by law.

Section 2.5 Affidavit of Notice . An affidavit of the Secretary or an Assistant Secretary or the transfer agent of the Corporation that notice of a stockholders meeting has been given shall, in the absence of fraud, be prima facie evidence of the facts stated therein.

Section 2.6 Quorum . Except as otherwise provided by law or by the Certificate of Incorporation, the holders of a majority of the Common Stock on a Fully Diluted, Converted and Exchanged Bases present in person or represented by proxy, shall constitute a quorum at all meetings of the stockholders for the transaction of business except as otherwise provided by statute or by the Certificate of Incorporation, provided a majority in number of Investors are present or represented by proxy. If, however, such quorum shall not be present or represented by proxy within 30 minutes following the scheduled time for a meeting of the stockholders, the meeting shall be adjourned to a date of which there shall be given notice of five business days and provided the matters dealt with at such adjourned meeting are the same, the holders of a majority of outstanding shares of Common Stock on a Fully Diluted, Converted and Exchanged Basis present in person or represented by proxy at such adjourned meeting shall constitute a quorum. If the adjournment is for more than thirty days, or if after the adjournment a new record date is fixed for the adjourned meeting, a notice of the adjourned meeting shall be given to each stockholder of record entitled to vote at the meeting.

Section 2.7 Voting Requirements . When a quorum is present at any meeting, the vote (which need not be by ballot) of the holders of a majority of the stock having voting power present in person or represented by proxy shall decide any question brought before such meeting, unless the question is one upon which by express provision of any applicable statute or of the Certificate of Incorporation, a different vote is required in which case such express provision shall govern and control the decision of such question.

 

2


Section 2.8 Proxies and Voting . Unless otherwise provided in the Certificate of Incorporation, each stockholder shall at every meeting of the stockholders be entitled to one vote in person or by proxy for each share of the capital stock having voting power held by such stockholder, but no proxy shall be voted on after three years from its date, unless the proxy provides for a longer period. Persons holding stock in a fiduciary capacity shall be entitled to vote the shares so held, and persons whose stock is pledged shall be entitled to vote the pledged shares, unless in the transfer by the pledgor on the books of the Corporation he shall have expressly empowered the pledgee to vote said shares, in which case only the pledgee, or his proxy, may represent and vote such shares. Shares of the capital stock of the Corporation owned by the Corporation shall not be voted, directly or indirectly.

Section 2.9 Action Without Meeting . Unless otherwise provided in the Certificate of Incorporation, any action required to be taken at any annual or special meeting of stockholders of the Corporation, or any action which may be taken at any annual or special meeting of such stockholders, may be taken without a meeting, without prior notice and without a vote, if a consent in writing or by electronic transmission meeting the requirements of the Delaware General Corporation Law, setting forth the action so taken, shall be signed (if in writing) or submitted (if by electronic transmission) by the holders of outstanding stock having not less than the minimum number of votes that would be necessary to authorize or take such action at a meeting at which all shares entitled to vote thereon were present and voted. Prompt notice of the taking of the corporate action without a meeting by less than unanimous written consent shall be given to those stockholders who have not consented in writing or by electronic transmission.

Section 2.10 Stockholder List . The officer who has charge of the stock ledger of the Corporation shall prepare and make, at least ten days before every meeting of stockholders, a complete list of the stockholders entitled to vote at 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, during ordinary business hours, for a period of at least ten days prior to the meeting either at a place within the city where the meeting is to be held, which place shall be specified in the notice of the meeting, or, if not so specified, at the place where the meeting is to be held. 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. The original or duplicate stock ledger shall be the only evidence as to who are the stockholders entitled to examine such list, the stock ledger or the books of the Corporation, or to vote in person or by proxy at any meeting of stockholders.

Section 2.11 Record Date . In order that the Corporation may determine the stockholders entitled to notice of or to vote at any meeting of stockholders or any adjournment thereof, or to express consent to corporate action in writing without a meeting, or entitled to receive payment of any dividend or other distribution or allotment of any rights, or entitled to exercise any rights in respect of any change, conversion or exchange of stock or for the purpose of any other lawful action, the Board of Directors may fix, in advance, a record date, which shall not be more than sixty nor less than ten days before the date of such meeting, nor more than sixty days prior to any other action. A determination of stockholders of record entitled to notice of or to vote at a

 

3


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.

If no record date is fixed by the Board of Directors:

(a) 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 next preceding the day on which notice is given, or, if notice is waived, at the close of business on the day next preceding the day on which the meeting is held.

(b) The record date for determining stockholders entitled to express consent to corporate action in writing without a meeting, when no prior action by the Board of Directors is necessary, shall be the day on which the first written consent is expressed.

(c) 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 thereto.

ARTICLE 3

DIRECTORS

Section 3.1 Number; Election and Term of Office . There shall be a Board of Directors of the Corporation consisting of not less than one member, the number of members to be determined by resolution of the Board of Directors or by the stockholders at the annual or any special meeting, unless the Certificate of Incorporation fixed the number of Directors, in which case a change in the number of Directors shall be made only by amendment of the Certificate. Subject to any limitation which may be contained within the Certificate of Incorporation or pursuant to a written agreement entered into among the stockholders of the Corporation, the number of the Board of Directors may be increased at any time by vote of a majority of the Directors then in office. The Directors shall be elected at the annual meeting of the stockholders, except as provided in paragraph (c) of Section 8.1, and each Director elected shall hold office until his successor is elected and qualified or until his earlier resignation or removal. Directors need not be stockholders.

Section 3.2 Duties . The business of the Corporation shall be managed by or under the direction of its Board of Directors which may exercise all such powers of the Corporation and do all such lawful acts and things as are not by statute or by the Certificate of Incorporation or by these Bylaws directed or required to be exercised or done by the stockholders.

Section 3.3 Compensation . Unless otherwise restricted by the Certificate of Incorporation or these Bylaws, the Board of Directors shall have the authority to fix the compensation, if any, of Directors. The Directors may be paid or reimbursement for their reasonable travel and other expenses, if any, of attendance at each meeting of the Board of Directors and any committee thereof and may be paid a fixed sum for attendance at each meeting of the Board of Directors or a stated salary as Directors. No such payment shall preclude any

 

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Director from serving the Corporation in any other capacity and receiving compensation therefor. Members of special or standing committees may be allowed like compensation and expense payment or reimbursement for attending committee meetings.

Section 3.4 Reliance on Books . A member of the Board of Directors or a member of any committee designated by the Board of Directors shall, in the performance of his duties, be fully protected in relying in good faith upon the books of account or reports made to the Corporation by any of its officers, or by an independent certified public accountant, or by an appraiser selected with reasonable care by the Board of Directors or by any committee, or in relying in good faith upon other records of the Corporation.

Section 3.5 No Casting Vote . Neither the President nor the chairman of a committee of the Board of Directors shall have a second or casting vote on any matter submitted to a vote at a meeting of the Board of Directors or a committee of the Board of Directors.

ARTICLE 4

MEETINGS OF THE BOARD OF DIRECTORS

Section 4.1 Place . The Board of Directors of the Corporation may hold meetings, both regular and special, either within or without the State of Delaware.

Section 4.2 Annual Meeting . The first meeting of each newly elected Board of Directors shall be held immediately following the annual meeting of stockholders and at the same place, and no notice of such meeting shall be necessary to the newly elected Directors in order legally to constitute the meeting. In the event that such first meeting is not held at that time and place, such first meeting may be held at such time and place as shall be specified in a notice given as provided herein for special meetings of the Board of Directors, or as shall be specified in a written waiver of notice signed by all of the directors.

Section 4.3 Regular Meetings . Regular meetings of the Board of Directors may be held following five business days’ notice at such time and at such place as shall from time to time be determined by the Board.

Section 4.4 Special Meetings . Special meetings of the Board may be called by the President on five business days’ notice to each Director; special meetings shall be called by the President or Secretary on like notice on the written request of two Directors unless the Board consists of only one Director, in which case special meetings shall be called by the President or Secretary on like notice on the written request of the sole Director.

Section 4.5 Notice of Meetings; Business at Meetings . Notice of each meeting of the Board of Directors, stating the time and place, an agenda for the meeting and, to the extent known as of the date of the giving of such notice, the purpose or purposes of the meeting, and accompanied by all available material and other information reasonably required to enable Directors to make decisions on an informed basis on the matters to be discussed at the meeting,

 

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shall be given to each member of the Board of Directors at least five business days’ prior to such meeting. The business transacted at a meeting of the Board of Directors need not be limited to the purpose or purposes stated in the notice of such meeting.

Section 4.6 Quorum . At all meetings of the Board of Directors, four directors then forming part of the Board of Directors, including two Investor Representatives (as such term is defined under the USA), shall constitute a quorum for the transaction of business and the act of a majority of the Directors present at any meeting at which there is a quorum shall be the act of the Board of Directors. If a quorum is not constituted at any meeting of the Board of Directors, the Directors present thereat may adjourn the meeting from time to time, without notice other than announcement at the meeting, until a quorum shall be present, provided that if a quorum is not constituted by reason of the absence of an Investor Representative, the meeting shall be adjourned to a date following by at least five business days the adjourned meeting and which shall be specified in a notice of meeting given in accordance with these Bylaws. The Directors present at such meeting, if they represent a majority of the directors then in office, shall constitute a quorum.

Section 4.7 Action Without Meeting . Unless otherwise restricted by the Certificate of Incorporation or these Bylaws, 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 or committee, as the case may be, consent thereto in writing or by electronic transmission, and such writing(s) or electronic transmission(s) are filed with the minutes of proceedings of the Board or committee. Filing of electronic transmissions shall be in paper form if the minutes of meetings of the Board of Directors are maintained in paper form and shall be in electronic form if such minutes are maintained in electronic form.

Section 4.8 Telephone Meetings . Unless otherwise restricted by the Certificate of Incorporation or these Bylaws, members of the Board of Directors, or any committee designated by the Board of Directors, may participate in a meeting of the Board of Directors, or any committee, by means of conference telephone or similar communications equipment by means of which all persons participating in the meeting can hear each other, and such participation in a meeting shall constitute presence in person at the meeting.

Section 4.9 Presumption of Assent . A director of the Corporation who is present at a meeting of the Board of Directors at which action on any matter is taken shall be presumed to have assented to the action taken unless his dissent shall be entered in the minutes of the meeting or unless he shall file his dissent to such action with the person acting as the Secretary of the meeting before the adjournment thereof or shall forward such dissent by registered mail to the Secretary of the Corporation immediately after the adjournment of such meeting. Such right to dissent shall not apply to a director who voted in favor of the action.

 

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ARTICLE 5

COMMITTEES OF DIRECTORS

Section 5.1 Designation .

(a) The Board of Directors may, by resolution passed by a majority of the whole Board, designate one or more committees, each committee to consist of one or more of the Directors of the Corporation. The Board 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.

(b) In the absence or disqualification of a member of a committee, the member or members thereof present at any meeting and not disqualified from voting, whether or not he or they 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.

(c) Any such committee, to the extent provided in the resolution of the Board of Directors designating the committee, shall have and may exercise all the powers and authority of the Board of Directors in the management of the business and affairs of the corporation, and may authorize the seal of the Corporation to be affixed to all papers which may require it; but no such committee shall have the power or authority in reference to amending the Certificate of Incorporation, adopting an agreement of merger or consolidation, recommending to the stockholders the sale, lease or exchange of all or substantially all of the Corporation’s property and assets, recommending to the stockholders a dissolution of the Corporation or a revocation of a dissolution, or amending the Bylaws of the Corporation; and, unless the resolution or the Certificate of Incorporation expressly so provide, no such committee shall have the power or authority to declare a dividend or to authorize the issuance of stock. Such committee or committees shall have such name or names as may be determined from time to time by resolution adopted by the Board of Directors.

Section 5.2 Records of Meetings . Each committee shall keep regular minutes of its meetings and report the same to the Board of Directors when required.

Section 5.3 Notice . Meetings of a committee of the Board of Directors may be called by the chairman of the committee or any two members of the committee. Notice of each meeting of the Board of Directors, stating the time and place, an agenda for the meeting and, to the extent known as of the date of the giving of such notice, the purpose or purposes of the meeting, and accompanied by all available material and other information reasonably required to enable Directors to make decisions on an informed basis on the matters to be discussed at the meeting, shall be given to each member of the Board of Directors at least five business days’ prior to such meeting. The business transacted at a meeting of the Board of Directors need not be limited to the purpose or purposes stated in the notice of such meeting.

Section 5.4 Quorum . At all meetings of a committee of the Board of Directors, a majority of directors then forming part of such committee, including one Investor Representative,

 

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shall constitute a quorum for the transaction of business and the act of a majority of the Directors present at any meeting at which there is a quorum shall be the act of such committee. If a quorum is not constituted at any meeting of a committee of the Board of Directors, the Directors present thereat may adjourn the meeting from time to time, without notice other than announcement at the meeting, until a quorum shall be present, provided that if a quorum is not constituted by reason of the absence of the Investor Representative, the meeting shall be adjourned to a date following by at least five business days the adjourned meeting and which shall be specified in a notice of meeting given in accordance with these Bylaws. The Directors present at such meeting, if they represent a majority of the Directors making up the committee of the Board of Directors, shall constitute a quorum.

ARTICLE 6

NOTICES

Section 6.1 Method of Giving Notice . Whenever, under any provision of the law or of the Certificate of Incorporation or of these Bylaws, notice is required to be given to any Director or stockholder, such notice shall be given by the Secretary or the person or persons calling the meeting. Each such notice shall be in writing or shall be delivered by means of electronic transmission in compliance with Delaware law. If not delivered by means of electronic transmission, such notice shall be delivered by hand to such Director or stockholder at his residence or usual place of business or by mailing such notice first-class mail, postage prepaid, addressed to such Director or stockholder, or by delivering such notice to an overnight courier service addressed to such Director or stockholder, in either case at his address as it appears on the records of the Corporation, with postage or delivery charges thereon prepaid, and such notice shall be deemed to be given at the time when the same shall be deposited in the United States mail or with said overnight courier.

Section 6.2 Waiver . Whenever any notice is required to be given under any provision of law or of the Certificate of Incorporation or of these Bylaws, a waiver thereof in writing or electronic transmission, signed (if in writing) by the person or persons entitled to said notice, whether before or after the time stated therein, shall be deemed equivalent thereto. Attendance of a person at a meeting shall constitute a waiver of notice of such meeting, except when the person attends the 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, and, having objected, such person takes no further active part in the meeting. Neither the business to be transacted at, nor the purpose of, any regular or special meeting of the stockholders, Board of Directors or members of a committee need be specified in any waiver of notice unless required by law.

 

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ARTICLE 7

OFFICERS

Section 7.1 General . The officers of the Corporation shall be chosen by the Board of Directors and shall include a President, a Secretary and a Treasurer. The Board of Directors may also choose a Chairman of the Board, one or more Vice-Presidents, Assistant Secretaries and Assistant Treasurers. Any number of offices may be held by the same person, unless the Certificate of Incorporation or these Bylaws otherwise provide.

Section 7.2 Election of President, Secretary and Treasurer . The Board of Directors at its first meeting after each annual meeting of stockholders shall choose a President, a Secretary and a Treasurer.

Section 7.3 Election of Other Officers . The Board of Directors may appoint such other officers and agents as it shall deem appropriate who shall hold their offices for such terms and shall exercise such powers and perform such duties as shall be determined from time to time by the Board.

Section 7.4 Salaries . The salaries of all officers and agents of the Corporation may be fixed by the Board of Directors. No officer shall be prevented from receiving such salary by reason of the fact that he is also a director of the Corporation.

Section 7.5 Term of Office . The officers of the Corporation shall hold office until their successors are chosen and qualify or until their earlier resignation or removal. Subject to the terms of any applicable employment or similar agreement with the Corporation, any officer elected or appointed by the Board of Directors may be removed at any time in the manner specified in Section 8.2.

Section 7.6 Duties of President and Chairman of the Board . The President shall be the chief executive officer of the Corporation, shall preside at all meetings of the stockholders and, if he is a Director, at all meetings of the Board of Directors if there shall be no Chairman of the Board or in the absence of the Chairman of the Board, shall have general and active management of the business of the Corporation and shall see that all orders and resolutions of the Board of Directors are carried into effect. The President shall execute bonds, mortgages and other contracts requiring a seal, under the seal of the Corporation, except where required or permitted by law to be otherwise signed and executed and except where the signing and execution thereof shall be expressly delegated by the Board of Directors to some other officer or agent of the Corporation. The Chairman of the Board, if any, shall make his counsel available to the other officers of the Corporation, shall be authorized to sign stock certificates on behalf of the Corporation, shall preside at all meetings of the Directors at which he is present, and, in the absence of the President at all meetings of the stockholders, and shall have such other duties and powers as may from time to time be conferred upon him by the Directors.

Section 7.7 Duties of Vice President . In the absence of the President or in the event of his inability or refusal to act, the Vice-President (or in the event there be more than one Vice-

 

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President, the Vice-Presidents in the order designated by the Directors, or in the absence of any designation, then in the order of their election) shall perform the duties of the President not otherwise conferred upon the Chairman of the Board, if any, and when so acting, shall have all the powers of and be subject to all the restrictions upon the President. The Vice-Presidents shall perform such other duties and have such other powers as the Board of Directors may from time to time prescribe.

Section 7.8 Duties of Secretary . The Secretary shall attend all meetings of the Board of Directors and all meetings of the stockholders and record all the proceedings of the meetings of the Corporation and of the Board of Directors in a book to be kept for that purpose and shall perform like duties for the standing committees when required. He shall give, or cause to be given, notice of all meetings of the stockholders and special meetings of the Board of Directors, except as otherwise provided in these Bylaws, and shall perform such other duties as may be prescribed by the Board of Directors or President, under whose supervision he shall be. He shall have charge of the stock ledger (which may, however, be kept by any transfer agent or agents of the Corporation under his direction) and of the corporate seal of the Corporation.

Section 7.9 Duties of Assistant Secretary . The Assistant Secretary, or if there be more than one, the Assistant Secretaries in the order determined by the Board of Directors (or if there be no such determination, then in the order of their election) shall, in the absence of the Secretary or in the event of his inability or refusal to act, perform the duties and exercise the powers of the Secretary and shall perform such other duties and have such other powers as the Board of Directors may from time to time prescribe.

Section 7.10 Duties of Treasurer . The Treasurer shall have the custody of the corporate funds and securities and shall keep full and accurate accounts of receipts and disbursements in books belonging to the Corporation and shall deposit all moneys and other valuable effects in the name and to the credit of the Corporation in such depositories as may be designated by the Board of Directors. The Treasurer shall disburse the funds of the Corporation as may be ordered by the Board of Directors, taking proper vouchers for such disbursements, and shall render to the President and the Board of Directors, at its regular meetings, or when the Board of Directors so requires, an account of all of his transactions as Treasurer and of the financial condition of the Corporation. If required by the Board of Directors, he shall give the Corporation a bond in such sum and with such surety or sureties as shall be satisfactory to the Board of Directors for the faithful performance of the duties of this office and for the restoration to the Corporation, in case of his death, resignation, retirement or removal from office, of all books, papers, vouchers, money and other property of whatever kind in his possession or under his control belonging to the Corporation.

Section 7.11 Duties of Assistant Treasurer . The Assistant Treasurer, or if there shall be more than one, the Assistant Treasurers in the order determined by the Board of Directors (or if there be no such determination, then in the order of their election), shall, in the absence of the Treasurer or in the event of his inability or refusal to act, perform the duties and exercise the powers of the Treasurer and shall perform such other duties and have such other powers as the Board of Directors may from time to time prescribe.

 

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ARTICLE 8

RESIGNATIONS, REMOVALS AND VACANCIES

Section 8.1 Directors .

(a) Resignations . Any Director may resign at any time by giving written notice to the Board of Directors or the President or the Secretary. Such resignation shall take effect at the time specified therein; and unless otherwise specified therein, the acceptance of such resignation shall not be necessary to make it effective.

(b) Removals . Subject to any provisions of the Certificate of Incorporation or a written agreement entered among the stockholders of the Corporation, the holders of stock entitled to vote for the election of Directors may, at any meeting called for the purpose, by vote of a majority of the shares of such stock outstanding, remove any Director or the entire Board of Directors with or without cause and fill any vacancies thereby created. This Section 8.1(b) may not be altered, amended or repealed except by the holders of a majority of the shares of stock issued and outstanding and entitled to vote for the election of the Directors.

(c) Vacancies . Vacancies occurring in the office of Director and newly created Directorships resulting from any increase in the authorized number of Directors shall be filled by a majority of the Directors then in office, though less than a quorum, unless previously filled by the stockholders entitled to vote for the election of Directors, whether pursuant to a written agreement entered into among the stockholders of the Corporation or otherwise, and the Directors so chosen shall hold office subject to the Bylaws until the next annual election and until their successors are duly elected and qualify or until their earlier resignation or removal. If there are no Directors in office, then an election of Directors may be held in the manner provided by statute.

Section 8.2 Officers . Subject to the terms of any applicable employment or similar agreement with the Corporation, any officer may resign at any time by giving written notice to the Board of Directors or the President or the Secretary. Such resignation shall take effect at the time specified therein; and unless otherwise specified therein, the acceptance of such resignation shall not be necessary to make it effective. The Board of Directors may, at any meeting called for the purpose, by vote of a majority of their entire number, remove from office any officer of the Corporation or any member of a committee, with or without cause. Any vacancy occurring in the office of President, Secretary or Treasurer shall be filled by the Board of Directors and the officers so chosen shall hold office subject to the Bylaws for the un-expired term in respect of which the vacancy occurred and until their successors shall be elected and qualify or until their earlier resignation or removal.

 

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ARTICLE 9

CERTIFICATE OF STOCK

Section 9.1 Issuance of Stock . The Directors may, at any time and from time to time, if all of the shares of capital stock which the Corporation is authorized by its Certificate of Incorporation to issue have not been issued, subscribed for, or otherwise committed to be issued, issue or take subscriptions for additional shares of its capital stock up to the amount authorized in its Certificate of Incorporation. Such stock shall be issued and the consideration paid therefor in the manner prescribed by law.

Section 9.2 Right to Certificate, Form . Every holder of stock in the Corporation shall be entitled to have a certificate, signed by, or in the name of the Corporation by, the Chairman of the Board, the President or a Vice-President and the Treasurer or an Assistant Treasurer, or the Secretary or an Assistant Secretary of the Corporation, certifying the number of shares owned by him in the Corporation; provided that the Directors may provide by one or more resolutions that some or all of any or all classes or series of the Corporation’s stock shall be uncertified shares. Certificates may be issued for partly paid shares and in such case upon the face or back of the certificates issued to represent any such partly paid shares, the total amount of the consideration to be paid therefor, and the amount paid thereon shall be specified.

Section 9.3 Facsimile Signature . Any of or all the signatures on the certificate may be facsimile. In case any officer, transfer agent or registrar who has signed or whose facsimile signature has been placed upon a certificate shall have ceased to be such officer, transfer agent or registrar before such certificate is issued, it may be issued by the Corporation with the same effect as if he were such officer, transfer agent or registrar at the date of issue.

Section 9.4 Lost Certificates . The Board of Directors may direct a new certificate or certificates to be issued in place of any certificate or certificates theretofore issued by the Corporation alleged to have been lost, stolen or destroyed, upon the making of an affidavit of that fact by the person claiming the certificate of stock to be lost, stolen or destroyed. When authorizing such issue of a new certificate or certificates, the Board of Directors may, in its discretion and as a condition precedent to the issuance thereof, require the owner of such lost, stolen or destroyed certificate or certificates, or his legal representative, to advertise the same in such manner as it shall require and/or to give the Corporation a bond in such sum as it may direct as indemnity against any claim that may be made against the Corporation with respect to the certificate alleged to have been lost, stolen or destroyed.

Section 9.5 Transfer of Stock . Upon surrender to the Corporation or the transfer agent of the Corporation of a certificate for shares duly endorsed or accompanied by proper evidence of succession, assignation or authority to transfer, it shall be the duty of the Corporation to issue a new certificate to the person entitled thereto, cancel the old certificate and record the transaction upon its books.

Section 9.6 Registered Stockholders . The Corporation shall be entitled to recognize the exclusive right of a person registered on its books as the owner of shares to receive dividends,

 

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and to vote as such owner, and to hold liable for calls and assessments a person registered on its books as the owner of shares, and shall not be bound to recognize any equitable or other claim to or interest in such share or shares on the part of any other person, whether or not it shall have express or other notice thereof, except as otherwise provided by the laws of Delaware.

ARTICLE 10

INDEMNIFICATION

Section 10.1 General .

(a) The Corporation shall, to the fullest extent permitted by the laws of Delaware, indemnify each person (including his or her heirs or legal representatives) who was or is a party or is threatened to be made a party to any threatened, pending or completed investigation, claim, 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 such person 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 or trustee of, or in a similar capacity with, another Corporation (including any partially or wholly owned subsidiary of the Corporation), partnership, joint venture, trust or other enterprise (including any employee benefit plan) (each of such persons being referred to as an “ Indemnitee ”), or by reason of any action alleged to have been taken or omitted in such capacity, against all costs, losses and expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by the Indemnitee or on the Indemnitee’s behalf in connection with such threatened, pending or completed investigation, claim, action, suit or proceeding, except in all cases those costs, losses and expenses resulting from his or her willful negligence. 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, did not act in a manner that the Indemnitee reasonably believed to be in, or not opposed to, the best interests of the Corporation or, with respect to any criminal action or proceeding, did not have reasonable cause to believe that the Indemnitee’s conduct was unlawful. Notwithstanding anything to the contrary in this Article 10, except as set forth in Section 10.3(b), the Corporation shall not indemnify an Indemnitee seeking indemnification in connection with a proceeding (or part thereof) initiated by the Indemnitee unless the initiation thereof was approved by the Board of Directors of the Corporation.

(b) The Corporation shall indemnify any Indemnitee who was or is a party or is 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 the Corporation’s 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 as a Director, officer or trustee of, or in a similar capacity with, another Corporation (including any partially or wholly owned subsidiary of the 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 amounts paid in settlement actually and reasonably incurred by

 

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the Indemnitee or on the Indemnitee’s behalf in connection with such action, suit or proceeding and any appeal therefrom, if the Indemnitee acted in good faith and in a manner the Indemnitee reasonably believed to be in, or not opposed to, the best interests of the Corporation, except that no indemnification shall be made 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) that the Court of Chancery of the State of Delaware shall deem proper.

(c) Notwithstanding any other provision of this Article 10, to the extent that an Indemnitee has been successful, on the merits or otherwise (including a disposition without prejudice), in defense of any action, suit or proceeding referred to in Section 10.1, 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 the Indemnitee or on the Indemnitee’s behalf 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 the Indemnitee 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 the Indemnitee’s conduct was unlawful, the Indemnitee shall be considered for the purposes hereof to have been wholly successful with respect thereto.

(d) If any Indemnitee is entitled under any provision of this Section 10.1 to indemnification by the Corporation for a portion, but not all, of the expenses (including attorneys’ fees), judgments, fines or amounts paid in settlement actually and reasonably incurred by the Indemnitee or on the Indemnitee’s behalf, the Corporation shall 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.

Section 10.2 Advancement of Expenses . Subject to Section 10.3(b), in the event that the Corporation does not assume a defense pursuant to 10.3(a) of any action, suit, proceeding or investigation of which the Corporation receives notice under this Article 10, any expenses (including attorneys’ fees) incurred by an Indemnitee in defending a civil or criminal 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 an 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 10. Any such undertaking by an Indemnitee shall be accepted without reference to the financial ability of the Indemnitee to make such repayment.

 

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Section 10.3 Indemnification Procedures .

(a) As a condition precedent to any Indemnitee’s right to be indemnified, the Indemnitee must promptly notify the Corporation in writing of any action, suit, proceeding or investigation involving the Indemnitee for which indemnity will or may 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 the Indemnitee; provided that 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 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 claim. 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 claim, other than as provided in Section 10.1. The Indemnitee shall have the right to employ the Indemnitee’s own counsel in connection with such claim, 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 has 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 or (iii) the Corporation has not in fact employed counsel to assume the defense of such action, 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 10.

(b) In order to obtain indemnification or advancement of expenses pursuant to this Article 10, an Indemnitee shall submit to the Corporation a written request therefor, which request shall include documentation and information as is reasonably available to the Indemnitee and is reasonably necessary to determine whether and to what extent the Indemnitee is entitled to indemnification or advancement of expenses. Any such indemnification or advancement of expenses shall be made promptly, and in any event within sixty days after receipt by the Corporation of the written request of the Indemnitee, unless with respect to requests under Sections 10.1(a), 10.1(b) or 10.2, the Corporation determines, by clear and convincing evidence, within such sixty-day period, that any Indemnitee did not meet the applicable standard of conduct set forth in 10.1(a), 10.1(b) or 10.2. Such determination shall be made in each instance by (i) 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”), even though less than a quorum, (ii) a majority vote of a quorum of the outstanding shares of capital stock of all classes entitled to vote for Directors, which quorum shall consist of stockholders who are not at that time parties to the action, suit, proceeding or investigation in question, (iii) independent legal counsel (who may be regular legal counsel to the Corporation), or (iv) a court of competent jurisdiction.

 

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(c) The right of an Indemnitee to indemnification or advancement of expenses pursuant to this Article 10 shall be enforceable by the Indemnitee in any court of competent jurisdiction if the Corporation denies, in whole or in part, a request of an Indemnitee in accordance with Section 10.3(b) or if no disposition thereof is made within the sixty-day period referred to in Section 10.3(b). Unless otherwise provided by law, the burden of proving that an Indemnitee is not entitled to indemnification or advancement of expenses pursuant to this Article 10 shall be on the Corporation. 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 any applicable standard of conduct, nor an actual determination by the Corporation pursuant to Section 10.3(b) 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) 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.

Section 10.4 Rights Not Exclusive . The right of an Indemnitee to indemnification and advancement of expenses pursuant to this Article 10 shall not be deemed exclusive of any other rights to which the Indemnitee may be entitled under any law (common or statutory), agreement, 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 serve in the capacity with respect to which the Indemnitee’s right to indemnification or advancement of expenses accrued, and shall inure to the benefit of the estate, heirs, executors and administrators of the Indemnitee. Nothing contained in this Article 10 shall be deemed to prohibit, and the Corporation is specifically authorized to enter into, agreements with officers and Directors providing indemnification rights and procedures supplemental to those set forth in this Article 10. 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 10. In addition, 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 (including any partially or wholly owned subsidiary of the Corporation), partnership, joint venture, trust or other enterprise (including any employee benefit plan) against any expense, liability or loss incurred by such a person in any such capacity, or arising out of such person’s 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 the State of Delaware.

Section 10.5 Subsequent Events .

(a) No amendment, termination or repeal of this Article 10 or of any relevant provisions of the General Corporation Law of the State of Delaware or any other applicable law shall affect or diminish in any way the rights of any Indemnitee to indemnification under the provisions of this Article 10 with respect to any action, suit, proceeding or investigation arising out of or relating to any actions, transactions or facts occurring prior to the effective date of such

 

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amendment, termination or repeal. If the General Corporation Law of the State of Delaware is amended after adoption of this Article 10 to expand further the indemnification permitted to any Indemnitee, then the Corporation shall indemnify the Indemnitee to the fullest extent permitted by the General Corporation Law of the State of Delaware, as so amended, without the need for any further action with respect to this Article 10.

(b) If the Corporation is merged into or consolidated with another Corporation and the Corporation is not the surviving Corporation, the surviving Corporation shall assume the obligations of the Corporation under this Article 10 with respect to any action, suit, proceeding or investigation arising out of or relating to any actions, transactions or factors occurring prior to the date of such merger or consolidation.

Section 10.6 Invalidation . If any or all of the provisions of this Article 10 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 provision of this Article 10 that shall not have been invalidated and to the fullest extent permitted by the General Corporation Law of the State of Delaware or any other applicable law.

Section 10.7 Definitions . Unless defined elsewhere in these Bylaws, any term used in this Article 10 and defined in Section 145(h) or (i) of the General Corporation Law of the State of Delaware shall have the meaning ascribed to such term in such Section 145(h) or (i), as the case may be.

ARTICLE 11

EXECUTION OF PAPERS

Except as otherwise provided in these Bylaws or as the Board of Directors may generally or in particular cases otherwise determine, all deeds, leases, transfers, contracts, bonds, notes, checks, drafts and other instruments authorized to be executed on behalf of the Corporation shall be executed by the President or the Treasurer.

ARTICLE 12

FISCAL YEAR

Except as from time to time otherwise determined by the Board of Directors, the fiscal year of the Corporation shall be the twelve months ending on December 31.

 

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ARTICLE 13

SEAL

The Corporate seal shall have inscribed thereon the name of the Corporation, the year of its organization and the word “Delaware.” The seal may be used by causing it or a facsimile thereof to be impressed or affixed or reproduced or otherwise.

ARTICLE 14

OFFICES

In addition to its principal office, the Corporation may have offices at such other places both within and without the State of Delaware as the Board of Directors may from time to time determine or the business of the Corporation may require.

ARTICLE 15

AMENDMENTS

Except as otherwise provided herein, these Bylaws may be altered, amended or repealed or new Bylaws may be adopted by the stockholders or by the Board of Directors, when such power is conferred upon the Board of Directors by the Certificate of Incorporation, at any regular meeting of the stockholders or of the Board of Directors, or at any special meeting of the stockholders or of the Board of Directors if notice of such alteration, amendment, repeal or adoption of new Bylaws is contained in the notice of such special meeting, or by the written consent of a majority in interest of the outstanding voting stock of the Corporation or by the unanimous written consent of the Directors. If the power to adopt, amend or repeal bylaws is conferred upon the Board of Directors by the Certificate of Incorporation, it shall not divest or limit the power of the stockholders to adopt, amend or repeal bylaws. Any amendment, alteration or modification of the terms of Article 10 of these Bylaws shall in no way diminish, reduce or affect the right of any person to receive indemnification pursuant to Article 10 for any and all actions occurring prior to the date of the adoption of such new terms.

 

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Exhibit 10.1.5

TARGANTA THERAPEUTICS CORPORATION

2005 STOCK OPTION PLAN

OPTION AGREEMENT

1. GRANT OF OPTION.

(a) GENERAL TERMS. Targanta Therapeutics Corporation, a Delaware corporation (the “ Company ”), hereby grants to the Grantee named in the Notice of Stock Option Grant (the “ Notice ”) attached to this Option Agreement (“ Agreement ”), an Option to purchase the total number of Shares set forth in the Notice, at the Option Price set forth in the Notice subject to the terms, definitions and provisions of the 2005 Stock Option Plan (the “ Plan ”) adopted by the Company, as the same may be amended from time to time, which is incorporated in this Agreement by reference. In the event of a conflict between the terms of the Plan and the terms of this Agreement, the terms of the Plan shall govern. Unless otherwise defined in this Agreement, the terms used in this Agreement shall have the meanings defined in the Plan.

(b) TAX STATUS OF OPTION FOR U.S. RESIDENTS. Unless and to the extent designated a Nonstatutory Stock Option in the Notice, this Option is intended to be an Incentive Stock Option as defined in Section 422 of the United States Internal Revenue Code of 1986, as amended (the “ Code ”), to the maximum extent permitted under applicable U.S. tax law. If any portion of this Option is designated as an Incentive Stock Option, it shall qualify as such only to the extent that the aggregate Fair Market Value of the Shares (generally, the Option’s Option Price) subject to this Option (and all other Incentive Stock Options granted to Grantee by the Company or Subsidiary) that first become exercisable in any calendar year does not exceed US$100,000. To the extent that the aggregate Fair Market Value of such Shares exceeds US$100,000, the Shares in excess of such limit shall be treated as a Nonstatutory Stock Option, in accordance with Article VI of the Plan.

2. EXERCISE OF OPTION. This Option shall be exercisable during its term in accordance with the Vesting Schedule set out in Section 4.3 of the Plan, or as otherwise set forth in the Notice, and with the provisions of Article VII of the Plan as follows, except to the extent that the Committee in its sole and absolute discretion may provide for acceleration of unvested options:

(a) RIGHT TO EXERCISE.

(i) This Option may not be exercised for a fraction of a share.

(ii) In no event may this Option be exercised after the Expiration Date of the Option as set forth in the Notice.

(iii) To the extent the Option is not vested at the date of termination of Service for any reason, the Option may not be exercised. For the purposes of this clause (iii), subject to any acceleration provisions agreed to in writing between the Company and the Grantee, the date of termination of Service shall be the date of actual termination of Service as determined by the Company without reference to any period of notice of termination of employment to which the Grantee may be entitled at law or pursuant to any employment agreement.

(iv) This Option is exercisable for no more than 365 days after the date that the Grantee’s Services terminate, if such termination is due to the Grantee’s death or permanent and total disability.


(v) This Option is exercisable for no more than ninety (90) days after the date that Grantee’s Services terminate (other than as a result of death or permanent and total disability or a Termination for Cause) (provided, that, for this purposes the date of termination of Service shall be the date of actual termination of Service as determined by the Company without reference to any period of notice of termination of employment to which the Grantee may be entitled at law or pursuant to any employment agreement).

(vi) This Option terminates immediately upon a Termination For Cause of Service of the Grantee’s.

(vii) With respect to any Incentive Stock Option that shall remain in effect after a change in status from Employee to Non-employee Director or consultant, such Incentive Stock Option shall cease to be treated as an Incentive Stock Option and shall be treated as a Non-Qualified Stock Option on the day three (3) months and one (1) day following such change in status.

(b) METHOD OF EXERCISE.

(i) This Option shall be exercisable by delivering to the Company an Exercise Notice in a form prescribed by the Company that shall state the election to exercise the Option, the whole number of Shares in respect of which the Option is being exercised, and such other representations and agreements as to the holder’s investment intent with respect to such Shares of Common Stock as may be required by the Company pursuant to the provisions of the Plan. Such written notice shall be signed by Grantee and shall be delivered in person or by certified mail to the corporate secretary of the Company. The written notice shall be accompanied by payment of the Option Price. This Option shall be deemed to be exercised upon receipt by the Company of such written notice accompanied by the payment of the Option Price as set forth in Section 4 below. GRANTEE UNDERSTANDS AND AGREES THAT THE EXERCISE NOTICE IMPOSES CERTAIN RESTRICTIONS ON TRANSFER (INCLUDING A MARKET STAND-OFF AGREEMENT), A RIGHT OF FIRST REFUSAL, A PLEDGE, A REPURCHASE OPTION AND A DRAG-ALONG ON THE SHARES, WHICH SHALL BE BINDING ON THE HOLDER OF THE SHARES AND ALL TRANSFEREES THEREOF.

(ii) As a condition to the exercise of this Option, Grantee agrees to make adequate provision for federal, state, provincial or other tax withholding obligations, if any, which arise upon the exercise of the Option or disposition of Shares issued thereunder, whether by withholding, direct payment to the Company, or otherwise.

(iii) No Shares shall be issued pursuant to the exercise of an Option unless such issuance and such exercise shall comply with all relevant provisions of law and the requirements of any stock exchange upon which the Shares may then be listed. Assuming such compliance, for income tax purposes the Shares shall be considered transferred to Grantee on the date on which the Option is exercised with respect to such Shares.

3. GRANTEE’S REPRESENTATIONS. In the event the Shares purchasable pursuant to the exercise of this Option have not been registered under the Securities Act, at the time this Option is exercised, Grantee shall, if required by the Company, concurrently with the exercise of all or any portion of this Option, deliver to the Company an investment representation statement in the customary form, a copy of which the Company will make available for Grantee’s review upon request.

 

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4. METHOD OF PAYMENT. Payment of the Option Price shall be by any of the following, or a combination of the following, in the sole discretion of the Committee:

(a) cash, personal or cashier’s check, wire transfer to the Company, or promissory note, but only to the extent and under the terms and conditions set forth in the Exercise Notice;

(b) if there is a public market for the Shares, and they are registered under the Securities Act, and subject to the requirements of the Securities Act (Ontario) and the Ontario Rule: (a) surrender of other Shares of Common Stock of the Company, that (i) either have been owned by Grantee for more than six (6) months on the date of surrender or were not acquired, directly or indirectly, from the Company, and (ii) have a Fair Market Value on the date of surrender equal to the aggregate Option Price of the Shares as to which the Option shall be exercised; (b) authorization to the Company to retain from the total number of Shares as to which the Option is exercised, the number of Shares having a Fair Market value on the date of exercise equal to the aggregate Option Price for the total number of Shares as to which the Option is exercised; or (c) delivery of a properly executed Exercise Notice together with irrevocable instructions to a broker to deliver promptly to the Company the amount of sale or loan proceeds required to pay the aggregate Option Price.

5. RESTRICTIONS ON EXERCISE.

(a) The exercise of this Option and the issuance of the Shares upon such exercise shall be subject to compliance by the Company and Grantee with all applicable requirements of law relating thereto and with all applicable regulations of any stock exchange (including the Nasdaq Global Market, if applicable) on which the Shares may be listed for trading at the time of such exercise and issuance.

(b) The inability of the Company to obtain approval from any regulatory body having authority deemed by the Company to be necessary to the lawful issuance and sale of any Shares pursuant to this Option shall relieve the Company and its directors and officers of any liability with respect to the non-issuance or sale of the Shares as to which such approval shall not have been obtained. The Company, however, shall use its best efforts to obtain all such approvals. The Option may not be exercised until such time as the Plan has been approved by the stockholders of the Company.

6. NON-TRANSFERABILITY OF OPTION. This Option may not be transferred in any manner otherwise than by will or by the laws of descent or distribution to Grantee’s Immediate Family. The designation of a beneficiary does not constitute a transfer. An Option may be exercised during the lifetime of Grantee only by Grantee or a transferee permitted by this section. The terms of this Option shall be binding upon the executors, administrators, heirs, successors and assigns of Grantee.

7. TERM OF OPTION. This Option may be exercised only within the term set out in the Notice and/or the Plan, and may be exercised during such term only in accordance with the Plan and the terms of this Option.

8. NO ADDITIONAL EMPLOYMENT RIGHTS. Grantee understands and agrees that the vesting of Options pursuant to the Vesting Schedule is earned only by continuing as a provider of Services (not through the act of being hired, being granted this Option or acquiring Shares). Grantee further acknowledges and agrees that nothing in this Agreement or the Plan shall confer upon Grantee any right with respect to continuation as an Employee, Non-Employee Director, Consultant, or service provider with the Company or any Subsidiary or Affiliated Entity, nor shall it interfere in any way with his or her right to or the Company’s or any Subsidiary’s or Affiliated Entity’s right to terminate his or her Service relationship at any time, with or without cause.

 

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9. U.S. TAX CONSEQUENCES. If Grantee is a resident of the U.S. or otherwise subject to taxation in the U.S., Grantee acknowledges that there are certain U.S. federal tax consequences of the exercise of this Option and disposition of the Shares under the law in effect as of the date of grant. GRANTEE SHOULD CONSULT HIS OR HER OWN TAX ADVISOR BEFORE EXERCISING THIS OPTION OR DISPOSING OF THE SHARES.

10. NOTICE OF DISQUALIFYING DISPOSITION. If the Option granted to Grantee in this Agreement is an Incentive Stock Option, and if Grantee sells or otherwise disposes of any of the Shares acquired pursuant to the Incentive Stock Option on or before the later of (i) the date two (2) years after the Date of Grant, or (ii) the date one (1) year after transfer of such Shares to Grantee upon exercise of the Incentive Stock Option, Grantee shall notify the Company in writing within thirty (30) days after the date of any such disposition. Grantee agrees that upon a Disqualifying Disposition, Grantee shall remit to the Company as set forth in Article XVII of the Plan the amount of any applicable federal, state, provincial and local withholding and employment taxes.

11. ACCELERATION OF VESTING. If upon, or within twenty-four (24) months following, a Transaction that occurs while the Optionee continues to provide Services to the Company or an Affiliated Entity, the Optionee’s Service to the Company or an Affiliated Entity is terminated, this Option shall become exercisable in full.

12. SIGNATURE. This Agreement shall be deemed executed by the Company and Grantee upon execution by such parties of the Notice attached to this Agreement.

 

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Exhibit 10.1.6

TARGANTA THERAPEUTICS CORPORATION

2005 STOCK OPTION PLAN

OPTION AGREEMENT FOR QUÉBEC EMPLOYEES

1. GRANT OF OPTION.

(a) GENERAL TERMS. Targanta Therapeutics Corporation, a Delaware corporation (the “ Company ”), hereby grants to the Grantee named in the Notice of Stock Option Grant (the “ Notice ”) attached to this Option Agreement (“ Agreement ”), an Option to purchase the total number of Shares set forth in the Notice, at the Option Price set forth in the Notice subject to the terms, definitions and provisions of the 2005 Stock Option Plan (the “ Plan ”) adopted by the Company, as the same may be amended from time to time, which is incorporated in this Agreement by reference. In the event of a conflict between the terms of the Plan and the terms of this Agreement, the terms of the Plan shall govern. Unless otherwise defined in this Agreement, the terms used in this Agreement shall have the meanings defined in the Plan.

(b) TAX STATUS OF OPTION FOR U.S. RESIDENTS. Unless and to the extent designated a Nonstatutory Stock Option in the Notice, this Option is intended to be an Incentive Stock Option as defined in Section 422 of the United States Internal Revenue Code of 1986, as amended (the “ Code ”), to the maximum extent permitted under applicable U.S. tax law. If any portion of this Option is designated as an Incentive Stock Option, it shall qualify as such only to the extent that the aggregate Fair Market Value of the Shares (generally, the Option’s Option Price) subject to this Option (and all other Incentive Stock Options granted to Grantee by the Company or Subsidiary) that first become exercisable in any calendar year does not exceed US$100,000. To the extent that the aggregate Fair Market Value of such Shares exceeds US$100,000, the Shares in excess of such limit shall be treated as a Nonstatutory Stock Option, in accordance with Article VI of the Plan.

2. EXERCISE OF OPTION. This Option shall be exercisable during its term in accordance with the Vesting Schedule set out in Section 4.3 of the Plan, or as otherwise set forth in the Notice, and with the provisions of Article VII of the Plan as follows, except to the extent that the Committee in its sole and absolute discretion may provide for acceleration of unvested options:

(a) RIGHT TO EXERCISE.

(i) This Option may not be exercised for a fraction of a share.

(ii) In no event may this Option be exercised after the Expiration Date of the Option as set forth in the Notice.

(iii) To the extent the Option is not vested at the date of termination of Service for any reason, the Option may not be exercised. For the purposes of this clause (iii), subject to any acceleration provisions agreed to in writing between the Company and the Grantee, the date of termination of Service shall be the date of actual termination of Service as determined by the Company without reference to any period of notice of termination of employment to which the Grantee may be entitled at law or pursuant to any employment agreement.

(iv) This Option is exercisable for no more than 365 days after the date that the Grantee’s Services terminate, if such termination is due to the Grantee’s death or permanent and total disability.


(v) This Option is exercisable for no more than ninety (90) days after the date that Grantee’s Services terminate (other than as a result of death or permanent and total disability or a Termination for Cause) (provided, that, for this purposes the date of termination of Service shall be the date of actual termination of Service as determined by the Company without reference to any period of notice of termination of employment to which the Grantee may be entitled at law or pursuant to any employment agreement).

(vi) This Option terminates immediately upon a Termination For Cause of Service of the Grantee’s.

(vii) With respect to any Incentive Stock Option that shall remain in effect after a change in status from Employee to Non-employee Director or consultant, such Incentive Stock Option shall cease to be treated as an Incentive Stock Option and shall be treated as a Non-Qualified Stock Option on the day three (3) months and one (1) day following such change in status.

(b) METHOD OF EXERCISE.

(i) This Option shall be exercisable by delivering to the Company an Exercise Notice in a form prescribed by the Company that shall state the election to exercise the Option, the whole number of Shares in respect of which the Option is being exercised, and such other representations and agreements as to the holder’s investment intent with respect to such Shares of Common Stock as may be required by the Company pursuant to the provisions of the Plan. Such written notice shall be signed by Grantee and shall be delivered in person or by certified mail to the corporate secretary of the Company. The written notice shall be accompanied by payment of the Option Price. This Option shall be deemed to be exercised upon receipt by the Company of such written notice accompanied by the payment of the Option Price as set forth in Section 4 below. GRANTEE UNDERSTANDS AND AGREES THAT THE EXERCISE NOTICE IMPOSES CERTAIN RESTRICTIONS ON TRANSFER (INCLUDING A MARKET STAND-OFF AGREEMENT), A RIGHT OF FIRST REFUSAL, A PLEDGE, A REPURCHASE OPTION AND A DRAG-ALONG ON THE SHARES, WHICH SHALL BE BINDING ON THE HOLDER OF THE SHARES AND ALL TRANSFEREES THEREOF.

(ii) As a condition to the exercise of this Option, Grantee agrees to make adequate provision for federal, state, provincial or other tax withholding obligations, if any, which arise upon the exercise of the Option or disposition of Shares issued thereunder, whether by withholding, direct payment to the Company, or otherwise.

(iii) No Shares shall be issued pursuant to the exercise of an Option unless such issuance and such exercise shall comply with all relevant provisions of law and the requirements of any stock exchange upon which the Shares may then be listed. Assuming such compliance, for income tax purposes the Shares shall be considered transferred to Grantee on the date on which the Option is exercised with respect to such Shares.

3. GRANTEE’S REPRESENTATIONS. In the event the Shares purchasable pursuant to the exercise of this Option have not been registered under the Securities Act, at the time this Option is exercised, Grantee shall, if required by the Company, concurrently with the exercise of all or any portion of this Option, deliver to the Company an investment representation statement in the customary form, a copy of which the Company will make available for Grantee’s review upon request.

 

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4. METHOD OF PAYMENT. Payment of the Option Price shall be by any of the following, or a combination of the following, in the sole discretion of the Committee:

(a) cash, personal or cashier’s check, wire transfer to the Company, or promissory note, but only to the extent and under the terms and conditions set forth in the Exercise Notice;

(b) if there is a public market for the Shares, and they are registered under the Securities Act, and subject to the requirements of the Securities Act (Ontario) and the Ontario Rule: (a) surrender of other Shares of Common Stock of the Company, that (i) either have been owned by Grantee for more than six (6) months on the date of surrender or were not acquired, directly or indirectly, from the Company, and (ii) have a Fair Market Value on the date of surrender equal to the aggregate Option Price of the Shares as to which the Option shall be exercised; (b) authorization to the Company to retain from the total number of Shares as to which the Option is exercised, the number of Shares having a Fair Market value on the date of exercise equal to the aggregate Option Price for the total number of Shares as to which the Option is exercised; or (c) delivery of a properly executed Exercise Notice together with irrevocable instructions to a broker to deliver promptly to the Company the amount of sale or loan proceeds required to pay the aggregate Option Price.

5. RESTRICTIONS ON EXERCISE.

(a) The exercise of this Option and the issuance of the Shares upon such exercise shall be subject to compliance by the Company and Grantee with all applicable requirements of law relating thereto and with all applicable regulations of any stock exchange (including the Nasdaq Global Market, if applicable) on which the Shares may be listed for trading at the time of such exercise and issuance.

(b) The inability of the Company to obtain approval from any regulatory body having authority deemed by the Company to be necessary to the lawful issuance and sale of any Shares pursuant to this Option shall relieve the Company and its directors and officers of any liability with respect to the non-issuance or sale of the Shares as to which such approval shall not have been obtained. The Company, however, shall use its best efforts to obtain all such approvals. The Option may not be exercised until such time as the Plan has been approved by the stockholders of the Company.

6. NON-TRANSFERABILITY OF OPTION. This Option may not be transferred in any manner otherwise than by will or by the laws of descent or distribution to Grantee’s Immediate Family. The designation of a beneficiary does not constitute a transfer. An Option may be exercised during the lifetime of Grantee only by Grantee or a transferee permitted by this section. The terms of this Option shall be binding upon the executors, administrators, heirs, successors and assigns of Grantee.

7. TERM OF OPTION. This Option may be exercised only within the term set out in the Notice and/or the Plan, and may be exercised during such term only in accordance with the Plan and the terms of this Option.

8. NO ADDITIONAL EMPLOYMENT RIGHTS. Grantee understands and agrees that the vesting of Options pursuant to the Vesting Schedule is earned only by continuing as a provider of Services (not through the act of being hired, being granted this Option or acquiring Shares). Grantee further acknowledges and agrees that nothing in this Agreement or the Plan shall confer upon Grantee any right with respect to continuation as an Employee, Non-Employee Director, Consultant, or service provider with the Company or any Subsidiary or Affiliated Entity, nor shall it interfere in any way with his or her right to or the Company’s or any Subsidiary’s or Affiliated Entity’s right to terminate his or her Service relationship at any time, with or without cause.

 

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9. U.S. TAX CONSEQUENCES. If Grantee is a resident of the U.S. or otherwise subject to taxation in the U.S., Grantee acknowledges that there are certain U.S. federal tax consequences of the exercise of this Option and disposition of the Shares under the law in effect as of the date of grant. GRANTEE SHOULD CONSULT HIS OR HER OWN TAX ADVISOR BEFORE EXERCISING THIS OPTION OR DISPOSING OF THE SHARES.

10. NOTICE OF DISQUALIFYING DISPOSITION. If the Option granted to Grantee in this Agreement is an Incentive Stock Option, and if Grantee sells or otherwise disposes of any of the Shares acquired pursuant to the Incentive Stock Option on or before the later of (i) the date two (2) years after the Date of Grant, or (ii) the date one (1) year after transfer of such Shares to Grantee upon exercise of the Incentive Stock Option, Grantee shall notify the Company in writing within thirty (30) days after the date of any such disposition. Grantee agrees that upon a Disqualifying Disposition, Grantee shall remit to the Company as set forth in Article XVII of the Plan the amount of any applicable federal, state, provincial and local withholding and employment taxes.

11. ACCELERATION OF VESTING. Upon the termination of the Optionee’s Service to the Company or any Affiliated Entity other than as a result of a Termination for Cause, the Shares shall vest in their entirety and the Employee shall have ninety (90) days following such termination to exercise all of the Shares covered by this Option. In addition, if upon, or within twenty-four (24) months following, a Transaction that occurs while the Optionee continues to provide Services to the Company or an Affiliated Entity, the Optionee’s Service to the Company or an Affiliated Entity is terminated, this Option shall become exercisable in full.

12. SIGNATURE. This Agreement shall be deemed executed by the Company and Grantee upon execution by such parties of the Notice attached to this Agreement.

 

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Exhibit 10.5

E MPLOYMENT A GREEMENT

T HIS E MPLOYMENT A GREEMENT (the “ Agreement ”) is made as of this 6 th day of May, 2007, by and between Targanta Therapeutics Corporation, (the “ Company ”), and Dr. Pierre Emile G. Etienne (“ Employee ”) (collectively, the “ Parties ”).

W HEREAS , the Company wishes to continue the employment of the Employee and to assure itself of the continued services of Employee on the terms set forth herein;

W HEREAS , Employee wishes to continue his employment under the terms set forth herein;

N OW , T HEREFORE , in consideration of the mutual promises and covenants contained herein, it is hereby agreed by and between the Parties hereto as follows:

1. E MPLOYMENT . The Company will continue to employ Employee and Employee shall serve the Company in the capacity of Chief Development Officer (“ CDO ”).

2. A T -W ILL E MPLOYMENT . It is understood and agreed by the Parties that this Agreement does not contain any promise or representation concerning the duration of Employee’s employment with the Company. Employee specifically acknowledges that his employment with the Company is at-will and except as otherwise prohibited by law, may be altered or terminated by either Employee or the Company at any time, with or without Cause (as defined below) and with or without notice. The nature, terms or conditions of Employee’s employment with the Company cannot be changed by any oral representation, custom, habit or practice. In addition, that the rate of salary, any bonuses, paid time off, other compensation, or vesting schedules are stated in units of years or months or weeks does not alter the at-will nature of the employment, and does not mean and should not be interpreted to mean that Employee is guaranteed employment to the end of any period of time or for any period of time. In the event of conflict between this disclaimer and any other statement, oral or written, present or future, concerning terms and conditions of employment, the at-will relationship confirmed by this disclaimer shall control. This at-will status cannot be altered except in a writing signed by Employee and approved by the Board of Directors of the Company (the “ Board of Directors ”).

3. D UTIES . Employee shall render exclusive, full-time services to the Company as its CDO. Employee shall report to the Company’s Chief Executive Officer. Employee shall perform services under this Agreement primarily at the office of the Company located in Indianapolis, Indiana (the “ Primary Location ”), and from time to time at such other locations (including Montreal, Quebec) as is necessary to perform the duties of CDO under this Agreement. Subject to the terms of this Agreement, Employee’s responsibilities, working conditions and duties may be changed, added to, diminished or eliminated during his employment at the sole discretion of the Board of Directors. During Employee’s employment with the Company he shall devote his reasonable best efforts and his full business time, skill and attention to the performance of his duties on behalf of the Company.


4. P OLICIES AND P ROCEDURES . Employee agrees that he is subject to and will comply with the policies and procedures of the Company as such policies and procedures may be modified, added to or eliminated from time to time at the sole discretion of the Company, except to the extent any such policy or procedure specifically conflicts with the express terms of this Agreement. Employee further agrees and acknowledges that any written or oral policies and procedures of the Company do not constitute contracts between the Company and Employee.

5. B ASE S ALARY . For all services rendered and to be rendered hereunder, the Company agrees to pay to the Employee, and the Employee agrees to accept a salary of $300,000 per annum (“ Base Salary ”) starting as of November 13, 2006, which salary will be paid periodically in accordance with normal Company payroll practices and shall be subject to such deductions and withholdings as the Company is required to make pursuant to law, or by further agreement with the Employee. Employee’s salary shall be subject to annual review and discretionary adjustment by the Board of Directors, which discretion shall be exercised reasonably.

6. S TOCK O PTIONS . In connection with Employee’s continued employment by the Company, and at the next regularly scheduled meeting of the Board of Directors or the Compensation Committee thereof, the Company will grant Employee additional options, expected to be an option to purchase 300,000 shares of the Company’s common stock, such options to be granted at the then-current fair market value of the common stock as determined by the Board of Directors or the Compensation Committee thereof (the “Options” ). The terms, conditions and limitations of the Options will be set forth in the Company’s 2005 Stock Option Plan (the “Plan”) and in the standard form of notice of stock option grant and stock option agreement to be approved by the Board of Directors and to be entered into by Employee, such terms and conditions expected to include provisions providing that the 100,000 of the Options shall be vested upon grant and the remaining Options shall vest quarterly over four years, commencing on the date of grant, subject to acceleration in certain circumstances as further described below and as follows: (a) 42,000 shares to accelerate and vest if the Company files with the United States Food and Drug Administration (the “FDA” ) a new drug application covering oritavancin prior to September 30, 2007; (b) 14,000 shares to accelerate and vest if the Company initiates a Phase 2 clinical study of oritavancin using a single dose of oritavancin to treat complicated skin and skin structure infections (to be measured by the first patient visit and dosing) prior to June 30, 2007; and (c) 14,000 to accelerate and vest if the Company initiates a Phase 2 clinical trial of oritavancin as indicated for pneumonia (measured by the first patient visit and dosing) prior to September 30, 2007. The Employee acknowledges and agrees that the terms of the stock option described above are subject to approval by the Board of Directors or the Compensation Committee thereof and the Employee shall have no right to any such stock option until it has been granted to the Employee by the Board of Directors or the Compensation Committee thereof. Employee shall be eligible to receive future grants of equity incentives as determined by the Board of Directors (or the compensation committee thereof) in its sole discretion. The Options shall be issued in replacement of the options previously granted to Employee pursuant to (i) that certain Stock Option Agreement dated July 10, 2003, between the Employee and Targanta Therapeutics, Inc. (f/k/a PhageTech, Inc.), a Canadian corporation and subsidiary of the Company ( “Targanta Quebec” ), for 919,656 common exchangeable shares of Targanta Quebec at an exercise price of $0.38 CDN (following the 150:1 reverse stock split, now

 

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exercisable for 61,310 shares at an exercise price of $57.00 CDN per share); and (ii) that certain Notice of Stock Option Grant dated March 29, 2006, between the Company and Employee for 400,000 shares of the Company’s common stock at an exercise price of $0.24 US (following the 150:1 reverse stock split, now exercisable for 2,667 shares at an exercise price of $36.00 US per share), which options the Employee shall tender to the Company for cancellation in exchange for the receipt of the Options described above.

7. B ONUS . Employee may be eligible to receive an annual performance bonus of up to 25% of his Base Salary (subject to employment taxes, withholding and deductions) for each year of this Agreement beginning January 1, 2007, based upon Employee’s achievements of certain milestones and performance objectives to be mutually agreed upon by the Board of Directors and the Employee (the “ Bonus ”). Except as expressly provided otherwise herein, Employee must remain employed by the Company throughout the applicable bonus year in order to be eligible for any Bonus. The Board of Directors, in its sole discretion, which shall be exercised reasonably, shall determine the extent to which Employee has achieved the performance targets upon which Employee’s Bonus is based, and the amount of Bonus to be paid to Employee, if any. Bonuses are not earned until they are approved in writing by the Board of Directors.

8. O THER B ENEFITS . While employed by the Company as provided herein:

(a) Employee Benefits. Employee shall be entitled to all benefits to which other executive officers of the Company are entitled, on terms comparable thereto, including, without limitation, participation in pension and profit sharing plans, 401(k) plan, group insurance policies and plans, medical, health, vision, and disability insurance policies and plans, and the like, which benefits may be maintained by the Company for the benefit of its executives. The Company reserves the right to alter and amend the benefits received by Employee from time to time at the Company’s discretion.

(b) Expense Reimbursement. Employee shall receive, against presentation of proper receipts and vouchers, reimbursement for direct and reasonable out-of-pocket expenses incurred by him in connection with the performance of his duties hereunder, according to the Company’s policies.

(c) Vacation. Employee will be entitled to twenty (20) vacation days per year, which will accrue in monthly increments.

9. C ONFIDENTIAL I NFORMATION , R IGHTS AND D UTIES .

(a) Proprietary Information. Employee will, as a condition to continuing his employment with the Company, execute and deliver to the Company an Agreement Re: Non-Competition, Non-Solicitation, Non-Disclosure and Ownership of Inventions in the form attached hereto as Exhibit A .

(b) Exclusive Property. Employee agrees that all Company-related business procured by the Employee, and all Company-related business opportunities and plans made known to Employee while employed by the Company, are and shall remain the permanent and exclusive property of the Company.

 

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(c) Non-Solicitation; Non-Competition. Employee agrees that following his last day of employment with the Company, he shall continue to comply with the non-competition and non-solicitation obligations set forth in the Agreement Re: Non-Competition, Non-Solicitation, Non-Disclosure and Ownership of Inventions for the entire time period set forth therein.

10. T ERMINATION . The Parties each acknowledge that either of the Parties has the right to terminate Employee’s employment with the Company at any time for any reason whatsoever, with or without Cause or advance notice.

(a) Payments through Termination. Except as provided herein, upon termination of Employee’s employment for any reason, whether voluntary or involuntary, or due to death or Disability, the Company’s obligation to make payments shall terminate except the Company shall pay Employee (or his estate) any amount of Base Salary and Bonus earned through the date of termination, any benefits vested through the date of termination, all unused vacation accrued through the date of termination, and any business expenses that were incurred but not reimbursed as of the date of termination. Except as provided herein, vesting of the Options and any other equity incentives granted to Employee shall cease on the date of termination.

(b) Severance Benefits Prior to a Change of Control. In the event that Employee’s employment is terminated either without Cause or due to his death or Disability prior to a Change of Control, Employee shall be entitled to receive the following severance pay and benefits in addition to the payments described in Section 10(a):

(i) Severance Pay. The equivalent of twelve (12) months (the “ Severance Pay Period ”) of Employee’s Base Salary as in effect immediately prior to the date of his termination, payable on the same basis and at the same time as previously paid and subject to employment tax withholdings and deductions, commencing on the first regularly scheduled pay date following the Effective Date of the Release;

(ii) Pro Rated Bonus. Unless the Employee’s termination is due to his death, the Employee shall be deemed to have earned (on a pro rated basis) as of the date of his termination that portion of any Bonus that the Board of Directors, in its discretion, otherwise would have awarded the Employee as of such date, based on his achieving (on a pro rated basis) the performance targets upon which Employee’s Bonus is based. The payment of any such pro rated Bonus shall be made by the Company in accordance with its standard policies and procedures following the end of the year in which the Bonus was earned; and

 

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(iii) Medical and Dental Benefits. Provided that Employee or his dependents are eligible for and timely elect continued coverage under the Company’s group health and/or dental insurance plans pursuant to the federal law known as “COBRA,” for the duration of the Severance Pay Period the Company shall reimburse Employee or his dependents for the cost of the COBRA premiums (less an amount equal to the employee portion of such premiums in accordance with the Company’s then standard employee policies regarding health and dental insurance premiums), provided , however , that the Company’s obligation to pay the COBRA premiums in respect of health and/or dental insurance, as the case may be, will cease immediately in the event Employee or his dependents (as the case may be) become eligible for other group health or dental insurance that is reasonably comparable in terms of the scope and cost of coverage during the Severance Pay Period, and Employee or his dependents shall promptly notify the Company if he/they become eligible to be covered by other group health or dental insurance during the Severance Pay Period. Except for any right Employee has to continue participation in the Company’s group health and dental plans under COBRA, all employee benefits shall terminate in accordance with the terms of the applicable benefit plans as of the date of termination of the Employee’s employment by the Company (or one of its subsidiaries).

(iv) Definition of Severance Benefits. The severance pay, pro rated Bonus and COBRA reimbursement described in Sections 10(b)(i) through (iii) above are collectively referred to as the “ Severance Benefits .”

(c) Severance Benefits Following a Change of Control. In the event that, within twenty four (24) months following a Change of Control, Employee’s employment is terminated without Cause or as a result of death or Disability, then, in addition to the payments described in Section 10(a), Employee shall be entitled to receive the Severance Benefits.

(d) Conditions for Receipt of Severance Benefits. The Company’s obligation to pay Severance Benefits shall be contingent upon the Executive signing a release in the form attached as Exhibit B ( “Release” ) and a written acknowledgment of Employee’s continuing obligations under the Agreement Re: Non-Competition, Non-Solicitation, Non-Disclosure and Ownership of Inventions.

(e) Definition of Cause. For purposes of this Agreement, “ Cause ” means (i) Employee’s incompetence or failure or refusal to perform satisfactorily any duties reasonably required of Employee by the Board of Directors and/or the Company (other than by reason of Disability), including Employee’s continuing inattention to or neglect of his duties and responsibilities reasonably assigned to him by the Company and/or its Board of Directors, which failure or inaction is not cured by Employee within 30 days of receiving written notice of such event or events giving rise to a claim of Cause; (ii) Employee’s violation of any law, rule or regulation (other than traffic violations, misdemeanors or similar offenses) or cease-and-desist order, court order, judgment, regulatory directive or agreement or Employee’s conviction of or plea of nolo contendere

 

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to any felony or a crime involving moral turpitude; (iii) the commission or omission of or engaging in any act or practice that constitutes a material breach of Employee’s fiduciary duty to the Company, involves personal dishonesty, fraud or misrepresentation on the part of Employee or demonstrates a willful or continuing disregard for the best interests of the Company; (iv) Employee’s engaging in dishonorable or disruptive behavior, practices or acts that would be reasonably expected to harm or bring disrepute to the Company, its subsidiaries, its business or any of its customers, employees or vendors; or (v) a breach by Employee of his obligations under the Agreement Re: Non-Competition, Non-Solicitation, Non-Disclosure and Ownership of Inventions or any Company code of conduct or ethics or other Company policies or practices. In any case where the Company believes that the Employee may be terminated for Cause, it shall provide Employee with a written notice setting forth, in reasonable detail, the factual basis for such claimed Cause prior to or at the time of such termination.

(f) Definition of Disability. For purposes of this Agreement, “ Disability ” means the Employee’s inability to carry out his job responsibilities for a continuous period of more than six (6) months as a result of illness (mental or physical), accident, or injury, as reasonably determined in the sole discretion of the Board of Directors.

11. C HANGE I N C ONTROL B ENEFITS .

(a) Definition of Change of Control. A “ Change of Control ” shall mean any of the following events, if and only if such event or events occurs after the Next Financing: (i) the dissolution or liquidation of the Company, (ii) any merger or consolidation of the Company with one (1) or more corporations where the Company is the surviving corporation and the stockholders of the Company (including any holder of exchangeable shares of the Canadian subsidiaries) immediately prior to such transaction do not own at least fifty percent (50%) of the Company’s outstanding capital stock (assuming the exchange of all outstanding exchangeable shares of the Canadian subsidiaries) immediately after such transaction, (iii) any merger or consolidation of the Company with one or more corporations where the Company is not the surviving corporation, or (iv) a sale of substantially all of the assets of the Company or fifty percent (50%) or more of the then outstanding shares of capital stock of the Company (assuming the exchange of all exchangeable shares of the Canadian subsidiaries) to another corporation or entity.

(b) Acceleration of Options upon a Change in Control. In the event that Employee’s employment is terminated without Cause at any time following a Change in Control or within thirty (30) days prior to the consummation of a Change of Control, then all Options issued to Employee in connection with this Agreement and any other options or shares of restricted stock then held by Employee that have not yet vested shall immediately vest such that all of the remaining unvested shares under the Options and any other equity incentive granted to Employee during the course of his employment by the Company shall, at the time of the termination without Cause, immediately become vested shares. All other terms and conditions set forth in the Options, the Plan, and applicable notices of stock option grant, stock option agreements and restricted stock agreements, if applicable, shall remain in full force and effect.

 

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(c) Section 4999 Compliance. If the Company reasonably determines after consultation with its counsel that any benefit accorded to the Employee under this Section 11 or any other provision or agreement between the Company and the Employee (“ Other Agreement ”) would cause the imposition of an excise tax upon the Employee under Section 4999 of the Internal Revenue Code of 1986, as amended (the “ Code ”), then the Company shall adjust the timing and/or the amount of any payment or benefit to the Employee pursuant to this Section 11 or Other Agreement so that the excise tax imposed by Section 4999 shall not be imposed upon any such payment or benefit due to the Employee. The Company shall consult with the Employee regarding such adjustments, but shall retain the power to control the timing and amounts of any such adjustments.

12. C ODE S ECTION  409A C OMPLIANCE . Because of the uncertainty of the application of Section 409A of the Internal Revenue Code of 1986, as amended (the “ Code ”) to payments pursuant to this Agreement, including, without limitation, payments pursuant to Sections 10 and 11 hereof, Employee agrees that if any such payments are subject to the provisions of Section 409A(a)(1) of the Code by reason of this Agreement, or any part thereof, being considered a “nonqualified deferred compensation plan” pursuant to Section 409A of the Code, then such payments shall be made in accordance with, and this Agreement automatically shall be amended in such a manner as to prevent any current or future payment to the Employee under this Agreement or the vesting of any Company stock option or other equity incentive held issued to the Employee becoming subject to Section 409A(a)(1) of the Code, including, without limitation, any necessary delay of six (6) months applicable to payment of deferred compensation to a “specified employee” (as defined in Section 409A(2)(B)(i) of the Code) upon separation from service. In the event that a six month delay is required, on the first regularly scheduled pay date following the conclusion of the delay period the Employee shall receive a lump sum payment in an amount equal to six (6) months of Employee’s Base Salary and thereafter, any remaining Severance Benefits shall be paid on the same basis and at the same time as previously paid and subject to employment tax withholdings and deductions. The Company and the Employee shall consult together in good faith to determine the manner in which this Agreement should be amended to avoid the application of Section 409A(a)(1) as provided herein while avoiding or minimizing any financial disadvantage to the Employee as might arise from such amendment, but in case of disagreement the decision of the Board of Directors shall govern, and the Company and the Employee shall be bound thereby.

13. M ISCELLANEOUS .

(a) Taxes; Withholding. Employee agrees to be responsible for the payment of any taxes due on any and all compensation, stock options, equity incentives and other benefits provided by the Company pursuant to this Agreement and hereby acknowledges that all payments made by the Company to Employee under this Agreement shall be reduced by any tax or other amounts required to be withheld by the Company under applicable law. Employee agrees to indemnify the Company and hold the Company harmless from any and all claims or penalties asserted against the Company for any

 

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failure to pay taxes due on any compensation, stock option, or benefit provided by the Company pursuant to this Agreement. Employee expressly acknowledges that the Company has not made, nor herein makes, any representation about the tax consequences of any consideration provided by the Company to Employee pursuant to this Agreement.

(b) Modification/Waiver. This Agreement may not be amended, modified, superseded, canceled, renewed or expanded, or any terms or covenants hereof waived, except by a writing executed by each of the parties hereto or, in the case of a waiver, by the party waiving compliance. Failure of any party at any time or times to require performance of any provision hereof shall in no manner affect his or its right at a later time to enforce the same. No waiver by a party of a breach of any term or covenant contained in this Agreement, whether by conduct or otherwise, in any one or more instances shall be deemed to be or construed as a further or continuing waiver of that or any other term or covenant in this Agreement.

(c) Successors and Assigns. This Agreement shall be binding upon and shall inure to the benefit of any successors or assignees of the business of the Company. This Agreement shall not be assignable by the Employee.

(d) Notices. All notices given hereunder shall be given by certified mail, addressed, or delivered by hand, to the other party at his or its address as set forth herein, or at any other address hereafter furnished by notice given in like manner. Employee promptly shall notify Company of any change in Employee’s address. Each notice shall be dated the date of its mailing or delivery and shall be deemed given, delivered or completed on such date.

(e) Governing Law; Personal Jurisdiction and Venue. This Agreement and all disputes relating to this Agreement shall be governed in all respects by the laws of the Commonwealth of Massachusetts without regard to its conflicts of laws principles, and all disputes hereunder shall be adjudicated in the courts of the Commonwealth of Massachusetts, to whose personal jurisdiction the Parties hereby consent.

(f) Entire Agreement. This Agreement, together with the Exhibits A and B attached hereto, sets forth the entire agreement and understanding of the parties hereto with regard to the employment of the Employee by the Company and supersedes any and all prior agreements, arrangements and understandings, written or oral, pertaining to the subject matter hereof, including but not limited to that certain Employment Agreement dated May 13, 2003 between the Employee and Targanta Quebec. No representation, promise or inducement relating to the subject matter hereof has been made to a party that is not embodied in these Agreements, and neither of the Parties shall be bound by or liable for any alleged representation, promise or inducement not so set forth. In consideration of the benefits provided to Employee hereunder, Employee hereby agrees that, in the event of his termination from the Company, such benefits shall be in complete satisfaction of any and all obligations that the Company may have to Employee. Notwithstanding the foregoing, each of the parties acknowledges that the Agreement re Non-Competition, Non-Solicitation, Non-Disclosure and Ownership of Inventions

 

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between the Employee and Targanta Quebec dated June 27, 2003 (the “ Canadian NDA ”, shall continue in effect accordance to its terms, provided that in the event of a conflict between the provisions of the Canadian NDA and the terms of Exhibit A, the terms of Exhibit A shall prevail.

(g) Severability.  If any portion or provision of this Agreement shall to any extent be declared illegal or unenforceable by a court of competent jurisdiction, then the remainder of this Agreement, or the application of such portion or provision in circumstances other than those as to which it is so declared illegal or unenforceable, shall not be affected thereby, and each portion and provision hereof shall be valid and enforceable to the fullest extent permitted by law.

(h) Employer. Employee shall be employed initially by the Company. During the term of this Agreement, Employee may be transferred to the employment of either or both of the Company’s Canadian subsidiaries, in which event the term “ Company ” as used herein in reference to the employer of Employee shall refer to said subsidiary(ies). Any such transfer to the employment of a subsidiary, and/or any such transfer back to the employment of Company, shall not otherwise alter or affect the terms or conditions of this Agreement, which shall continue to govern Employee’s employment relationship.

(i) Counterparts. This Agreement may be executed in two counterparts, each of which shall be an original and all of which together shall constitute one and the same instrument.

(j) Fees.  Each party shall be responsible for its own fees and expenses incurred in connection with negotiating this Agreement.

[Remainder of Page Intentionally Left Blank.]

 

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I N W ITNESS W HEREOF , the Parties have each duly executed this Agreement as of the day and year first above written.

 

T ARGANTA T HERAPEUTICS C ORPORATION
By:   /s/ Mark Leuchtenberger
Name:   Mark Leuchtenberger
Title:   President and CEO
/s/ Pierre Emile G. Etienne
Dr. Pierre Emile G. Etienne

 

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Exhibit 10.6

E MPLOYMENT A GREEMENT

T HIS E MPLOYMENT A GREEMENT (the “ Agreement ”) is made as of this 8 th day of May, 2007, by and between Targanta Therapeutics Corporation, (the “ Company ”), and Dr. Thomas R. Parr (“ Employee ”) (collectively, the “ Parties ”).

W HEREAS , the Company wishes to continue the employment of the Employee and to assure itself of the continued services of Employee on the terms set forth herein;

W HEREAS , Employee wishes to be so employed under the terms set forth herein;

N OW , T HEREFORE , in consideration of the mutual promises and covenants contained herein, it is hereby agreed by and between the Parties hereto as follows:

1. E MPLOYMENT . The Company will continue to employ Employee and Employee shall serve the Company in the capacity of Chief Scientific Officer (“ CSO ”).

2. A T -W ILL E MPLOYMENT . It is understood and agreed by the Parties that this Agreement does not contain any promise or representation concerning the duration of Employee’s employment with the Company. Employee specifically acknowledges that his employment with the Company is at-will and except as otherwise prohibited by law, may be altered or terminated by either Employee or the Company at any time, with or without Cause (as defined below) and with or without notice. The nature, terms or conditions of Employee’s employment with the Company cannot be changed by any oral representation, custom, habit or practice. In addition, that the rate of salary, any bonuses, paid time off, other compensation, or vesting schedules are stated in units of years or months or weeks does not alter the at-will nature of the employment, and does not mean and should not be interpreted to mean that Employee is guaranteed employment to the end of any period of time or for any period of time. In the event of conflict between this disclaimer and any other statement, oral or written, present or future, concerning terms and conditions of employment, the at-will relationship confirmed by this disclaimer shall control. This at-will status cannot be altered except in a writing signed by Employee and approved by the Board of Directors of the Company (the “ Board of Directors ”).

3. D UTIES . Employee shall render exclusive, full-time services to the Company as its CSO. Employee shall report to the Company’s Chief Executive Officer. Employee shall perform services under this Agreement primarily at the office of the Company to be located in Indianapolis, Indiana (the “ Primary Location ”), and from time to time at such other locations (including Montreal, Quebec) as is necessary to perform the duties of CSO under this Agreement. Subject to the terms of this Agreement, Employee’s responsibilities, working conditions and duties may be changed, added to, diminished or eliminated during his employment at the sole discretion of the Board of Directors. During Employee’s employment with the Company he shall devote his reasonable best efforts and his full business time, skill and attention to the performance of his duties on behalf of the Company.

4. P OLICIES AND P ROCEDURES . Employee agrees that he is subject to and will comply with the policies and procedures of the Company as such policies and procedures may be


modified, added to or eliminated from time to time at the sole discretion of the Company, except to the extent any such policy or procedure specifically conflicts with the express terms of this Agreement. Employee further agrees and acknowledges that any written or oral policies and procedures of the Company do not constitute contracts between the Company and Employee.

5. B ASE S ALARY . For all services rendered and to be rendered hereunder, the Company agrees to pay to the Employee, and the Employee agrees to accept a salary of $220,000 per annum (“ Base Salary ”) starting as of November 13, 2006, which salary will be paid periodically in accordance with normal Company payroll practices and shall be subject to such deductions and withholdings as the Company is required to make pursuant to law, or by further agreement with the Employee. Employee’s salary shall be subject to annual review and discretionary adjustment by the Board of Directors, which discretion shall be exercised reasonably; provided that, upon the consummation of a future financing transaction or series of related transactions (including a so-called reverse merger of the Company with an existing public company), which such transaction or transactions shall be approved by the Board of Directors and result in aggregate proceeds to the Company and its subsidiaries of at least $20,000,000 from persons who are not presently stockholders of the Company (including any holder of exchangeable shares of the Canadian subsidiaries) (a “ Next Financing ”), the Employee’s Base Salary shall automatically be increased to $250,000 per annum, and upon the consummation of an initial public offering of the Company’s common stock (which for this purpose should include a so-called reverse merger of the Company with an existing public company), the Employee’s Base Salary shall automatically be increased to $275,000 per annum.

6. S TOCK O PTIONS . In connection with Employee’s continued employment by the Company, and at the next regularly scheduled meeting of the Board of Directors or the Compensation Committee thereof, the Company will grant Employee additional options, expected to be an option to purchase 150,000 shares of the Company’s common stock, such options to be granted at the then-current fair market value of the common stock as determined by the Board of Directors or the Compensation Committee thereof (the “ Options ”). The terms, conditions and limitations of the Options will be set forth in the Company’s 2005 Stock Option Plan (the “ Plan ”) and in the standard form of notice of stock option grant and stock option agreement to be approved by the Board of Directors and to be entered into by Employee, such terms and conditions expected to include provisions providing that 25% of the Options shall be vested at the time of grant and the remaining Options shall vest quarterly over four years, commencing on the date of grant, subject to acceleration in certain circumstances as further described below. The Employee acknowledges and agrees that the terms of the stock option described above are subject to approval by the Board of Directors or the Compensation Committee thereof and the Employee shall have no right to any such stock option until it has been granted to the Employee by the Board of Directors or the Compensation Committee thereof. Employee shall be eligible to receive future grants of equity incentives as determined by the Board of Directors (or the compensation committee thereof) in its sole discretion. The Options shall be issued in replacement of the options previously granted to Employee pursuant to (a) an option to purchase 250,000 shares of the Company’s Common Stock on March 29, 2006 at $0.24 per share (following the 150:1 reverse stock split, now exercisable for 1,666 shares at an exercise price of CDN $36.00 per share) and (b) an option to purchase 229,944 shares of the capital stock of Targanta Therapeutics, Inc. (f/k/a PhageTech, Inc.), a Canadian corporation and

 

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subsidiary of the Company ( “Targanta Quebec” ), at an exercise price of $0.38 CDN (following the 150:1 reverse stock split, now exercisable for 1,532 shares at an exercise price of $57.00 CDN per share), which options the Employee shall tender to the Company for cancellation in exchange for the receipt of the Options described above.

7. B ONUS . Employee may be eligible to receive an annual performance bonus of up to 25% of his Base Salary (subject to employment taxes, withholding and deductions) for each year of this Agreement beginning January 1, 2007, based upon Employee’s achievements of certain milestones and performance objectives to be mutually agreed upon by the Board of Directors and the Employee (the “ Bonus ”). Except as expressly provided otherwise herein, Employee must remain employed by the Company throughout the applicable bonus year in order to be eligible for any Bonus. The Board of Directors, in its sole discretion, which shall be exercised reasonably, shall determine the extent to which Employee has achieved the performance targets upon which Employee’s Bonus is based, and the amount of Bonus to be paid to Employee, if any. Bonuses are not earned until they are approved in writing by the Board of Directors.

8. O THER B ENEFITS . While employed by the Company as provided herein:

(a) Employee Benefits. Employee shall be entitled to all benefits to which other executive officers of the Company are entitled, on terms comparable thereto, including, without limitation, participation in pension and profit sharing plans, 401(k) plan, group insurance policies and plans, medical, health, vision, and disability insurance policies and plans, and the like, which benefits may be maintained by the Company for the benefit of its executives. The Company reserves the right to alter and amend the benefits received by Employee from time to time at the Company’s discretion.

(b) Expense Reimbursement. Employee shall receive, against presentation of proper receipts and vouchers, reimbursement for direct and reasonable out-of-pocket expenses incurred by him in connection with the performance of his duties hereunder, according to the Company’s policies.

(c) Vacation. Employee will be entitled to twenty (20) vacation days per year, which will accrue in monthly increments.

9. C ONFIDENTIAL I NFORMATION , R IGHTS AND D UTIES .

(a) Proprietary Information. Employee will, as a condition to commencing his employment with the Company, execute and deliver to the Company an Agreement Re: Non-Competition, Non-Solicitation, Non-Disclosure and Ownership of Inventions in the form attached hereto as Exhibit A .

(b) Exclusive Property. Employee agrees that all Company-related business procured by the Employee, and all Company-related business opportunities and plans made known to Employee while employed by the Company, are and shall remain the permanent and exclusive property of the Company.

 

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(c) Non-Solicitation; Non-Competition. Employee agrees that following his last day of employment with the Company, he shall continue to comply with the non-competition and non-solicitation obligations set forth in the Agreement Re: Non-Competition, Non-Solicitation, Non-Disclosure and Ownership of Inventions for the entire time period set forth therein.

10. T ERMINATION . The Parties each acknowledge that either of the Parties has the right to terminate Employee’s employment with the Company at any time for any reason whatsoever, with or without Cause or advance notice.

(a) Payments through Termination. Except as provided herein, upon termination of Employee’s employment for any reason, whether voluntary or involuntary, or due to death or Disability, the Company’s obligation to make payments shall terminate except the Company shall pay Employee (or his estate) any amount of Base Salary and Bonus earned through the date of termination, any benefits vested through the date of termination, all unused vacation accrued through the date of termination, and any business expenses that were incurred but not reimbursed as of the date of termination. Except as provided herein, vesting of the Options and any other equity incentives granted to Employee after the date hereof shall cease on the date of termination.

(b) Severance Benefits Prior to a Change of Control. In the event that Employee’s employment is terminated either without Cause or due to his death or Disability prior to a Change of Control, Employee shall be entitled to receive the following severance pay and benefits in addition to the payments described in Section 10(a):

(i) Severance Pay. The equivalent of six (6) months (the “ Severance Pay Period ”) of Employee’s Base Salary as in effect immediately prior to the date of his termination, payable on the same basis and at the same time as previously paid and subject to employment tax withholdings and deductions, commencing on the first regularly scheduled pay date following the Effective Date of the Release;

(ii) Pro Rated Bonus. Unless the Employee’s termination is due to his death, the Employee shall be deemed to have earned (on a pro rated basis) as of the date of his termination that portion of any Bonus that the Board of Directors, in its discretion, otherwise would have awarded the Employee as of such date, based on his achieving (on a pro rated basis) the performance targets upon which Employee’s Bonus is based. The payment of any such pro rated Bonus shall be made by the Company in accordance with its standard policies and procedures following the end of the year in which the Bonus was earned; and

(iii) Medical and Dental Benefits. Provided that Employee or his dependents are eligible for and timely elect continued coverage under the Company’s group health and/or dental insurance plans pursuant to the federal law

 

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known as “COBRA,” for the duration of the Severance Pay Period the Company shall reimburse Employee or his dependents for the cost of the COBRA premiums (less an amount equal to the employee portion of such premiums in accordance with the Company’s then standard employee policies regarding health and dental insurance premiums), provided , however , that the Company’s obligation to pay the COBRA premiums in respect of health and/or dental insurance, as the case may be, will cease immediately in the event Employee or his dependents (as the case may be) become eligible for other group health or dental insurance that is reasonably comparable in terms of the scope and cost of coverage during the Severance Pay Period, and Employee or his dependents shall promptly notify the Company if he/they become eligible to be covered by other group health or dental insurance during the Severance Pay Period. Except for any right Employee has to continue participation in the Company’s group health and dental plans under COBRA, all employee benefits shall terminate in accordance with the terms of the applicable benefit plans as of the date of termination of the Employee’s employment by the Company (or one of its subsidiaries).

(iv) Definition of Severance Benefits. The severance pay, pro rated Bonus and COBRA reimbursement described in Sections 10(b)(i) through (iii) above are collectively referred to as the “ Severance Benefits .”

(c) Severance Benefits Following a Change of Control. In the event that, within twenty four (24) months following a Change of Control, Employee’s employment is terminated without Cause or as a result of death or Disability, or Employee resigns for Good Reason, then, in addition to the payments described in Section 10(a), Employee shall be entitled to receive the Severance Benefits; provided , that the Severance Pay Period shall be twelve (12) months instead of six (6) months.

(d) Conditions for Receipt of Severance Benefits. The Company’s obligation to pay Severance Benefits shall be contingent upon the Executive signing a release in the form attached as Exhibit B (“Release”) and a written acknowledgment of Employee’s continuing obligations under the Agreement Re: Non-Competition, Non-Solicitation, Non-Disclosure and Ownership of Inventions.

(e) Definition of Cause. For purposes of this Agreement, “ Cause ” means (i) Employee’s incompetence or failure or refusal to perform satisfactorily any duties reasonably required of Employee by the Board of Directors and/or the Company (other than by reason of Disability), including Employee’s continuing inattention to or neglect of his duties and responsibilities reasonably assigned to him by the Company and/or its Board of Directors, which failure or inaction is not cured by Employee within 30 days of receiving written notice of such event or events giving rise to a claim of Cause; (ii) Employee’s violation of any law, rule or regulation (other than traffic violations, misdemeanors or similar offenses) or cease-and-desist order, court order, judgment, regulatory directive or agreement or Employee’s conviction of or plea of nolo contendere to any felony or a crime involving moral turpitude; (iii) the commission or omission of or engaging in any act or practice that constitutes a material breach of Employee’s

 

5


fiduciary duty to the Company, involves personal dishonesty, fraud or misrepresentation on the part of Employee or demonstrates a willful or continuing disregard for the best interests of the Company; (iv) Employee’s engaging in dishonorable or disruptive behavior, practices or acts that would be reasonably expected to harm or bring disrepute to the Company, its subsidiaries, its business or any of its customers, employees or vendors; or (v) a breach by Employee of his obligations under the Agreement Re: Non-Competition, Non-Solicitation, Non-Disclosure and Ownership of Inventions or any Company code of conduct or ethics or other Company policies or practices. In any case where the Company believes that the Employee may be terminated for Cause, it shall provide Employee with a written notice setting forth, in reasonable detail, the factual basis for such claimed Cause prior to or at the time of such termination.

(f) Definition of Good Reason. For purposes of this Agreement, “ Good Reason ” means (i) the failure of the Company to employ Employee in his current or a substantially similar position with the same reporting relationship, without regard to title, such that his duties and responsibilities are materially diminished without his written consent ( provided that he notifies the Company in writing of such diminution of duties within 45 days of the diminution); (ii) a reduction in Employee’s Base Salary and/or target annual Bonus without his written consent (unless such reduction is in connection with a proportional reduction in compensation to all or substantially all of the Company’s employees); or (iii) a permanent relocation of Employee’s Primary Location more than 50 miles from his current site of employment without Employee’s written consent.

(g) Definition of Disability. For purposes of this Agreement, “ Disability ” means the Employee’s inability to carry out his job responsibilities for a continuous period of more than six (6) months as a result of illness (mental or physical), accident, or injury, as reasonably determined in the sole discretion of the Board of Directors.

11. C HANGE I N C ONTROL B ENEFITS .

(a) Definition of Change of Control. A Change of Control ” shall mean any of the following events, if and only if such event or events occurs after the Next Financing: (i) the dissolution or liquidation of the Company, (ii) any merger or consolidation of the Company with one (1) or more corporations where the Company is the surviving corporation and the stockholders of the Company (including any holder of exchangeable shares of the Canadian subsidiaries) immediately prior to such transaction do not own at least fifty percent (50%) of the Company’s outstanding capital stock (assuming the exchange of all outstanding exchangeable shares of the Canadian subsidiaries) immediately after such transaction, (iii) any merger or consolidation of the Company with one or more corporations where the Company is not the surviving corporation, or (iv) a sale of substantially all of the assets of the Company or fifty percent (50%) or more of the then outstanding shares of capital stock of the Company (assuming the exchange of all exchangeable shares of the Canadian subsidiaries) to another corporation or entity.

 

6


(b) Acceleration of Options upon a Change in Control. In the event that (i) Employee’s employment is terminated without Cause at any time following a Change in Control or within thirty (30) days prior to the consummation of a Change of Control or (ii) Employee resigns for Good Reason at any time following a Change of Control, then all Options issued to Employee in connection with this Agreement and any other options or shares of restricted stock then held by Employee that have not yet vested shall immediately vest such that all of the remaining unvested shares under the Options and any other equity incentive granted to Employee during the course of his employment by the Company shall, at the time of the termination without Cause or resignation for Good Reason, immediately become vested shares. All other terms and conditions set forth in the Options, the Plan, and applicable notices of stock option grant, stock option agreements and restricted stock agreements, if applicable, shall remain in full force and effect.

(c) Section 4999 Compliance. If the Company reasonably determines after consultation with its counsel that any benefit accorded to the Employee under this Section 11 or any other provision or agreement between the Company and the Employee (“ Other Agreement ”) would cause the imposition of an excise tax upon the Employee under Section 4999 of the Internal Revenue Code of 1986, as amended (the “ Code ”), then the Company shall adjust the timing and/or the amount of any payment or benefit to the Employee pursuant to this Section 11 or Other Agreement so that the excise tax imposed by Section 4999 shall not be imposed upon any such payment or benefit due to the Employee. The Company shall consult with the Employee regarding such adjustments, but shall retain the power to control the timing and amounts of any such adjustments.

12. C ODE S ECTION  409A C OMPLIANCE . Because of the uncertainty of the application of Section 409A of the Internal Revenue Code of 1986, as amended (the “ Code ”) to payments pursuant to this Agreement, including, without limitation, payments pursuant to Sections 10 and 11 hereof, Employee agrees that if any such payments are subject to the provisions of Section 409A(a)(1) of the Code by reason of this Agreement, or any part thereof, being considered a “nonqualified deferred compensation plan” pursuant to Section 409A of the Code, then such payments shall be made in accordance with, and this Agreement automatically shall be amended in such a manner as to prevent any current or future payment to the Employee under this Agreement or the vesting of any Company stock option or other equity incentive held issued to the Employee becoming subject to Section 409A(a)(1) of the Code, including, without limitation, any necessary delay of six (6) months applicable to payment of deferred compensation to a “specified employee” (as defined in Section 409A(2)(B)(i) of the Code) upon separation from service. In the event that a six month delay is required, on the first regularly scheduled pay date following the conclusion of the delay period the Employee shall receive a lump sum payment in an amount equal to six (6) months of Employee’s Base Salary and thereafter, any remaining Severance Benefits shall be paid on the same basis and at the same time as previously paid and subject to employment tax withholdings and deductions. The Company and the Employee shall consult together in good faith to determine the manner in which this Agreement should be amended to avoid the application of Section 409A(a)(1) as provided herein while avoiding or minimizing any financial disadvantage to the Employee as might arise from such amendment, but in case of disagreement the decision of the Board of Directors shall govern, and the Company and the Employee shall be bound thereby.

 

7


13. M ISCELLANEOUS .

(a) Taxes; Withholding. Employee agrees to be responsible for the payment of any taxes due on any and all compensation, stock options, equity incentives and other benefits provided by the Company pursuant to this Agreement and hereby acknowledges that all payments made by the Company to Employee under this Agreement shall be reduced by any tax or other amounts required to be withheld by the Company under applicable law. Employee agrees to indemnify the Company and hold the Company harmless from any and all claims or penalties asserted against the Company for any failure to pay taxes due on any compensation, stock option, or benefit provided by the Company pursuant to this Agreement. Employee expressly acknowledges that the Company has not made, nor herein makes, any representation about the tax consequences of any consideration provided by the Company to Employee pursuant to this Agreement.

(b) Modification/Waiver. This Agreement may not be amended, modified, superseded, canceled, renewed or expanded, or any terms or covenants hereof waived, except by a writing executed by each of the parties hereto or, in the case of a waiver, by the party waiving compliance. Failure of any party at any time or times to require performance of any provision hereof shall in no manner affect his or its right at a later time to enforce the same. No waiver by a party of a breach of any term or covenant contained in this Agreement, whether by conduct or otherwise, in any one or more instances shall be deemed to be or construed as a further or continuing waiver of that or any other term or covenant in this Agreement.

(c) Successors and Assigns. This Agreement shall be binding upon and shall inure to the benefit of any successors or assignees of the business of the Company. This Agreement shall not be assignable by the Employee.

(d) Notices. All notices given hereunder shall be given by certified mail, addressed, or delivered by hand, to the other party at his or its address as set forth herein, or at any other address hereafter furnished by notice given in like manner. Employee promptly shall notify Company of any change in Employee’s address. Each notice shall be dated the date of its mailing or delivery and shall be deemed given, delivered or completed on such date.

(e) Governing Law; Personal Jurisdiction and Venue. This Agreement and all disputes relating to this Agreement shall be governed in all respects by the laws of the Commonwealth of Massachusetts without regard to its conflicts of laws principles, and all disputes hereunder shall be adjudicated in the courts of the Commonwealth of Massachusetts, to whose personal jurisdiction the Parties hereby consent.

(f) Entire Agreement. This Agreement, together with the Exhibits A and B attached hereto, sets forth the entire agreement and understanding of the parties hereto

 

8


with regard to the employment of the Employee by the Company and supersedes any and all prior agreements, arrangements and understandings, written or oral, pertaining to the subject matter hereof, including but not limited to that certain Employment Agreement dated December 23, 2004 between the Employee and Targanta Quebec. No representation, promise or inducement relating to the subject matter hereof has been made to a party that is not embodied in these Agreements, and neither of the Parties shall be bound by or liable for any alleged representation, promise or inducement not so set forth. In consideration of the benefits provided to Employee hereunder, Employee hereby agrees that, in the event of his termination from the Company, such benefits shall be in complete satisfaction of any and all obligations that the Company may have to Employee. Notwithstanding the foregoing, each of the parties acknowledges that the Agreement re Non-Competition, Non-Solicitation, Non-Disclosure and Ownership of Inventions between the Employee and Targanta Quebec dated January 17, 2005 (the “ Canadian NDA ”, shall continue in effect accordance to its terms, provided that in the event of a conflict between the provisions of the Canadian NDA and the terms of Exhibit A, the terms of Exhibit A shall prevail.

(g) Severability.  If any portion or provision of this Agreement shall to any extent be declared illegal or unenforceable by a court of competent jurisdiction, then the remainder of this Agreement, or the application of such portion or provision in circumstances other than those as to which it is so declared illegal or unenforceable, shall not be affected thereby, and each portion and provision hereof shall be valid and enforceable to the fullest extent permitted by law.

(h) Employer. Employee shall be employed initially by the Company. During the term of this Agreement, Employee may be transferred to the employment of either or both of the Company’s Canadian subsidiaries, in which event the term “ Company ” as used herein in reference to the employer of Employee shall refer to said subsidiary(ies). Any such transfer to the employment of a subsidiary, and/or any such transfer back to the employment of Company, shall not otherwise alter or affect the terms or conditions of this Agreement, which shall continue to govern Employee’s employment relationship.

(i) Counterparts. This Agreement may be executed in two counterparts, each of which shall be an original and all of which together shall constitute one and the same instrument.

(j) Fees.  Each party shall be responsible for its own fees and expenses incurred in connection with negotiating this Agreement.

[Remainder of Page Intentionally Left Blank.]

 

9


I N W ITNESS W HEREOF , the Parties have each duly executed this Agreement as of the day and year first above written.

 

T ARGANTA T HERAPEUTICS C ORPORATION
By:   /s/ Mark Leuchtenberger
Name:   Mark Leuchtenberger
Title:   President and CEO
/s/ Thomas R. Parr
Dr. Thomas R. Parr

 

10

Exhibit 10.8

COUDERT BROTHERS

LEASE

- Multi-Tenant Building -

BETWEEN

SOCIÉTÉ IMMOBILÌRE TECHNOLOGIQUE DE MONTRÉAL INC.

AS LANDLORD

AND

PHAGETECH INC.

AS TENANT


TABLE OF CONTENTS

 

         PAGE
ARTICLE   TITLE   
  1.   DEFINITIONS, INTENT AND INTERPRETATION    1
  2.   LEASED PREMISES    9
  3.   LANDLORD’S WORK AND TENANT’S FIT-UP    9
  4.   OCCUPANCY AND DELIVERY DATE    14
  5.   TERM OF LEASE    16
  6.   USE OF LEASED PREMISES    16
  7.   BASIC MINIMUM RENT, ADMINISTRATIVE FEES AND PAYMENT OF RENT    18
  8.   ADDITIONAL RENT    19
  9.   SALES TAXES    25
10.   INSURANCE    25
11.   COMMON AREAS AND FACILITIES AND RULES AND REGULATIONS    29
12.   REPAIRS AND MAINTENANCE    31
13.   ALTERATIONS, MODIFICATIONS OR IMPROVEMENTS    35
14.   DESTRUCTION OF THE LEASED PREMISES    37
I5.   SUBLET AND ASSIGNMENT    40
16.   DEFAULT OF TENANT    45
17.   SIGNS, EXHIBIT OF LEASED PREMISES    48
18.   COMPLIANCE WITH LAWS AND REGULATIONS    48
19.   INDEMNIFICATION    51
20.   EXPROPRIATION    53
21.   PERMITS    53
22.   FORBEARANCE OR INDULGENCE    54
23.   INTEREST    54
24.   [ INTENTIONALLY DELETED ]    54
25.   MOVABLE HYPOTHEC    54


26.    STATUS CERTIFICATES AND SUBORDINATION    55
27.    LEGAL HYPOTHECS    55
28.    PEACEABLE ENJOYMENT    56
29.    OUTSIDE AREAS    56
30.    DEPOSIT    57
31.    MISCELLANEOUS    57
32.    NOTICES    61
33.    ADDITIONAL SECURITY    62
34.    ADDITIONAL CLAUSES AND LANGUAGE    63

 

SCHEDULE “A” -   DESCRIPTION OF PROPERTY AND LEASED PREMISES COMPOSED OF:
  SCHEDULE “A-l” -LEGAL DESCRIPTION OF THE LANDS AND THE BUILDING
  SCHEDULE “A-2” - PLAN SHOWING THE PROPERTY (PHASE 2 OF TECHNOPARC SAINT-LAURENT) AND THE APPROXIMATE LOCATION OF THE BUILDING ON THE PROPERTY
  SCHEDULE “A-3” - PLAN SHOWING THE LEASED PREMISES
SCHEDULE “B-1”   DESCRIPTION OF LANDLORD’S WORK: BASE BUILDING LEASEHOLD IMPROVEMENTS (SPECIFICATIONS)
SCHEDULE “C” -   COPY OF BY-LAW NUMBER 1160-1 OF THE CITY OF SAINT-LAURENT
SCHEDULE “D” -   RULES AND REGULATIONS
SCHEDULE “E” -   ADDITIONAL CLAUSES
SCHEDULE “F” -   TECHNOPARC SERVITUDE
SCHEDULE “G” -   CERTIFIED COPY OF RESOLUTION OF TENANT
SCHEDULE “H” -   FORM OF IRREVOCABLE TRANSFERABLE LETTER OF CREDIT
SCHEDULE “I” -   ENVIRONMENTAL QUESTIONNAIRE
SCHEDULE “J” -   MANUAL PROCEDURE FOR CLEANING

 

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LEASE AGREEMENT entered into at the City of Saint-Laurent, Province of Quebec, the                                          (      ) day of April, two thousand and two (2002).

 

BETWEEN:    SOCIÉTÉ IMMOBILIÈRE TECHNOLOGlQUE DE MONTRÉAL INC ., a corporation duly incorporated, having its establishment directly concerned at 7150 Albert-Einstein, Suite 200, Saint-Laurent, Quebec, H4S 2C1, herein acting and represented by Citec Administration Inc., itself acting and represented by Daniel Bouffard, its President, and by Claude Normandeau, one of its Directors, duly authorized for the purposes hereof as they so declare (hereinafter called the “Landlord”);

 

   PARTY OF THE FIRST PART;

 

AND:    PHAGETECH INC ., a corporation duly incorporated, having its establishment directly concerned at 3575 du Parc Avenue, Suite 5315A, Montreal, Quebec, H2X 3P0, herein acting and represented by Dalai Manoli, its President and Chief Executive Officer, duly authorized for the purposes hereof by virtue of a resolution of the board, of directors of this corporation, adopted on the FIFTEEN (15 th ) day of April, two thousand and two (2002), a certified copy of which is annexed hereto as Schedule “G” (hereinafter called the “Tenant”).

 

   PARTY OF THE SECOND PART.

WHEREAS the Landlord has agreed to lease to the Tenant and the Tenant has agreed to lease from the Landlord upon the terms and conditions herein contained, certain premises forming part of a building located in Phase 2 of the Technoparc Saint-Laurent, in the City of Saint-Laurent, Province of Quebec.

NOW, THEREFORE, THIS AGREEMENT WITNESSETH THAT, IN CONSIDERATION OF THE RENTS, COVENANTS AND AGREEMENTS HEREINAFTER CONTAINED, THE PARTIES HEREBY AGREE AS FOLLOWS:

 

1. DEFINITIONS, INTENT AND INTERPRETATION

 

  1.1 Definitions - When used in this Lease or in any Schedule attached to this Lease, the following words or expressions shall have the meanings hereinafter respectively set forth:

 

  1.1.1 “Additional Rent” means any and all sums of money or charges required to be paid by the Tenant under this Lease except Basic Minimum Rent, whether or not the same are designated “Additional Rent” and, unless otherwise specifically provided, Additional Rent is due and payable with and in addition to each monthly installment of Basic Minimum Rent;

 

  1.1.2 “Architect” means the architect from time to time named by the Landlord whose decision or certificate, whenever required hereunder, shall be final and binding on the parties hereto;

 

  1.1.3 “Basic Minimum Rent” means the rent specified in Section 7.1 hereof;


  1.1.4 “Building” means the building having a civic address at 7170 Frederick-Banting Street, Saint-Laurent, Quebec, erected on the Lands and all structures, additions, improvements, facilities and amenities forming a part thereof from time to time and forming part of the Property and which building is designated as Building F on Schedule “A-2” annexed hereto and outlined in red thereon;

 

  1.1.5 “Building Share” means the share apportioned by the Landlord in an equitable manner to the Building, of all charges, impositions, costs and expenses of every nature and kind (including Taxes) relating to the Common Areas and Facilities (including the parking) of the Property. In any such apportionment and allocation of Operating Costs and Taxes, the Landlord shall charge any item which relates exclusively to one of the Property buildings directly to that building only, and, in respect of items which do not exclusively relate to any single building of the Property, the Landlord shall divide, apportion and allocate the same to all buildings (including the Building) forming part of the Property affected thereby, on an equitable basis;

 

  1.1.6 “Business Day” means any day which is not a Sunday or a holiday, as defined in the Interpretation Act (Quebec), as the same may be amended, re-enacted or replaced;

 

  1.1.7 “Commencement Date” means the commencement date specified in Section 5.2 hereof;

 

  1.1.8 “Common Areas and Facilities” means those areas, facilities, improvements, equipment and installations in, on or about the Building, the Lands or the Property which serve or are for the benefit of the Building, the Lands or the Property whether or not located within, adjoining to or near the Building, the Lands or the Property, and from time to time are intended or designated by the Landlord as common areas and facilities for the common use and benefit of tenants, their employees, customers and others of the Property. Common Areas and Facilities include, without limitation, the roof, exterior curtain walls, exterior and interior structural elements and bearing walls, electrical, plumbing, drainage and mechanical installations, heating, ventilation and air-conditioning installations, janitor rooms, signage and fire safety and security systems of the Building, public passageways, elevators, public parking areas and common public areas, roadways, sidewalks, curbs, driveways, common loading areas, truck courts, landscaped areas, fencing and other enclosures. The Landlord reserves the right to remove, replace or rearrange any or all of the said common areas and facilities without any claim or recourse by the Tenant against the Landlord by reason of such removal, replacement or rearrangement including, without limitation, any abatement of Rent, provided that notwithstanding said rearrangement, the Building and the Property remain a first class building and property and the Leased Premises may be used for the purposes for which they were leased;

 

  1.1.9 “Event of Default” has the meaning ascribed to it in Section 16.1 hereof;

 

  1.1.10 “Hypothecary Creditor” means any hypothecary creditor or mortgagee, including any trustee for bondholders, from time to time of the Property or any part thereof;

 

  1.1.11 “Landlord” means the Party of the First Part and its successors and assigns;

 

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  1.1.12 “Landlord’s Sales Taxes” means any and all taxes imposed on the Landlord with respect to Operating Costs whether characterized as a goods and services tax, sales tax or other similar tax;

 

  1.1.13 “Landlord’s Work” means the base building leasehold improvements to be constructed or erected in the Leased Premises or in any part thereof by the Landlord at its expense and described in Schedule “B-l” attached hereto;

 

  1.1.14 “Lands” means the lands, on a portion of which the Building has been constructed and which are more fully described in Schedule “A-l” annexed hereto and are shown on the certificate of location annexed hereto as Schedule “A-2”;

 

  1.1.15 “Lease” means the present lease agreement together with its Schedules and any written modification or amendment thereto made in accordance with Section 31.3 hereof;

 

  1.1.16 “Leased Premises” means the premises leased to the Tenant pursuant to this Lease forming part of the Building, the whole as described in Section 2.1 hereof;

 

  1.1.17 “Operating Costs” means the aggregate of any and all costs and expenses incurred by or on behalf of the Landlord of whatsoever nature or kind, without duplication, in connection with the operation, maintenance, repair including replacement, management, administration, insurance, heating, air-conditioning and ventilating of the Leased Premises, the Building, the Lands, the Property and the Common Areas and Facilities of the Building, of the Lands and of the Property, or any part thereof, the whole subject to the other provisions of this Lease. For greater certainty, and without limitation, Operating Costs shall include an administration fee of all of the aforesaid costs and expenses as provided in Section 8.5 hereof and save for the aforesaid administration fee, shall be without profit to the Landlord.

Notwithstanding the above and the definition of Common Areas and Facilities, Operating Costs shall exclude or have deducted from them, as the case may be:

 

  (i) capital expenditures and other expenses necessary to complete the original construction of the Building (including the initial landscaping of the Lands and initial construction of the parking and other elements of the Property, if any) and the capital expenditures and other expenses of remedying construction inadequacies pertaining to the base Building (including Schedule “Bl” Landlord’s Work) or pertaining to the initial landscaping of the Lands or the initial construction of the parking and other elements of the Property, if any;

 

  (ii) all amounts that otherwise would be included in Operating Costs which are the responsibility of other tenants of the Building or which are recovered or are recoverable by the Landlord from other tenants in the Building or the Property, as a result of any act, omission, default or negligence of such tenants;

 

  (iii)

such of the Operating Costs as are recovered from insurance proceeds or which would be recoverable assuming compliance by the Landlord with its insurance obligations under the Lease, to the extent such recovery represents reimbursement for costs previously included in Operating Costs

 

-3-


 

(whether or not the proceeds are paid to the Landlord or its Hypothecary Creditor(s)) or if the Landlord self-insures or is deemed to self-insure, to the extent of a corresponding application of reserves (it being understood that at the present time no such reserve exists and if it does exist, it would not result in increasing Operating Costs by an amount greater than the costs of insurance premiums) but in any event excluding any item for which the Landlord has not made a claim for compensation if the decision not to claim is for the benefit of the Tenant and/or tenants of the Building;

 

  (iv) the cost of advertising in respect of the Building or the Property or the Technoparc Saint-Laurent;

 

  (v) repairs or replacements to the footings, foundations, structural columns and beams, structural sub-floors, bearing walls, and other parts of the structure of the Building as well as repairs or additions required by applicable laws in effect at the time the Building is delivered to the Tenant; repairs to exterior walls, windows or the roof of the Building are not considered structural and will be included in Operating Costs;

 

  (vi) net recoveries by the Landlord in respect of warranties or guarantees relating to the construction of the Building or the construction of the parking on the Property and other elements of the Property, if any, to the extent that such repair costs in respect of the work covered by such warranties or guarantees have been charged in Operating Costs;

 

  (vii) expenses incurred for work or services performed solely for a particular tenant in excess of those services normally performed on behalf of tenants in the Building;

 

  (viii) leasing commissions incurred with respect to the leasing of space in the Building or the Property;

 

  (ix) any amounts paid by the Landlord as a fine or penalty as a result of a breach of law by the Landlord with respect to the Building, the Leased Premises or the Property (provided such breach was not caused by or contributed to by the Tenant);

 

  (x) tenant inducement payments and rent-free periods granted to the Tenant;

 

  (xi) any depreciation of the original capital cost of the Building and its original components or of any original structures located on the lands upon which the Building is situated;

 

  (xii) costs incurred in leasing premises in the Building to other tenants and the Tenant and the cost incurred in enforcing the leases of other tenants and the Tenant;

 

  (xiii) all interest, legal costs and other costs resulting from the financing of the whole or part of the Property and costs for penalties incurred by reason of the default of the Landlord to respect its hypothecary obligations or its obligations under other financial instruments affecting the whole or part of the Property;

 

-4-


  (xiv) any reserve for bad debts;

 

  (xv) the rental costs for any space used for the administration of the Property and occupied by the employees of the Landlord (no matter in what building);

 

  (xvi) the costs of the Tenant’s Fit-Up of the Leased Premises;

 

  (xvii) fines or penalties incurred as a result of the Landlord’s negligence or its failure to respect its obligations under this Lease or any law in effect, provided that the same do not result from the fault or negligence of the Tenant or any person for whom the Tenant is in law responsible;

 

  (xviii) the costs of removing, cleaning or disposing of asbestos, PCBs, contaminants or pollutants or other toxic substances or dangerous products affecting the Property but only to the extent that such asbestos, PCBs, contaminants or pollutants or other toxic substances or dangerous products were introduced into the Property by the Landlord or which were introduced into the Property prior to the commencement of the Lease and any fines or penalties relating thereto; and

 

  (xix) any emphyteutic rent or rent payable by the Landlord in respect of the Property.

In calculating Operating Costs, the costs (not otherwise excluded as set forth above) of renovations, improvements or betterments to the Building which have a useful life in the Landlord’s opinion of longer than one fiscal year of the Landlord shall be amortized over the useful life of the related asset or such other period as is reasonably determined by the Landlord in accordance with generally accepted accounting principles and such amortized amount shall form part of Operating Costs; Operating Costs shall also include depreciation of capital (and interest on the undepreciated capital at a rate charged or chargeable by the Landlord’s bankers from time to time) of the costs of all repairs, replacements, modifications and improvements relating to the Property which by their nature require repair or replacement from time to time and of other items designated by the Landlord, acting reasonably, as capital expenditures.

 

  1.1.18 “Prime Rate” means the rate of interest, expressed as an annual rate, in effect from time to time, quoted by the Royal Bank of Canada as its prime rate with respect to commercial loans in Canadian Dollars to its commercial borrowers in Canada;

 

  1.1.19 “Property” means the phase commonly known as Phase 2 of the Technoparc Saint-Laurent as outlined in blue on Schedule “A-2” annexed hereto and includes, without limitation, the Building and the Lands. The Property shall be sufficient to accommodate the Tenant’s parking as set forth in Section 29.2 hereof;

 

  1.1.20 “Proportionate Share” means the ratio which the Rentable Area of the Leased Premises bears to the Rentable Area of the Building expressed as a percentage. Should the Rentable Area of the Building increase or decrease, the Tenant’s proportionate share will be adjusted accordingly as of the date (as determined by the Landlord) of said change in the Rentable Area of the Building;

 

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  1.1.21 “Rent” shall mean Basic Minimum Rent and Additional Rent;

 

  1.1.22 “Rentable Area of the Building” means the aggregate rentable area of all leasable premises in the Building, expressed in square feet, as certified by the Architect (whose certificate shall be final and binding on the parties hereto) and measured in accordance with BOMA (ANSI Z65.1.1996) standards of measurement;

 

  1.1.23 “Rentable Area of the Leased Premises” means the aggregate of the rentable area of the Leased Premises, expressed in square feet, as certified by the Architect (whose certificate shall be final and binding) and measured in accordance with BOMA (ANSI Z65. 1.1996) standards of measurement, and the Tenant’s Proportionate Share of interior Common Areas and Facilities of the Building;

 

  1.1.24 “Rental Year” means a period of time, the first (1st) Rental Year commencing on the first (1st) day of the Term and ending on the thirty-first (31st) day of December next following; thereafter each Rental Year shall consist of consecutive periods of twelve (12) calendar months commencing on the first (1st) day of January and ending on the thirty-first (31st) day of December, provided, however, that the last Rental Year shall terminate upon the expiration of the Term or earlier termination of this Lease, as the case may be. Notwithstanding the foregoing, the Landlord may, at anytime and from time to time during the Term, change the Rental Year in which case the then current Rental Year shall terminate on the date preceding the commencement of such new Rental Year;

 

  1.1.25 “Rules and Regulations” means the rules and regulations adopted and promulgated by the Landlord from time to time, which rules and regulations are presently those annexed hereto as Schedule “D”;

 

  1.1.26 “Stipulated Rate of Interest” means the Prime Rate plus four percent (4%) as an annual rate compounded monthly;

 

  1.1.27 “Surtax” means the surtax imposed by any competent authority on non-residential immovables by virtue of the Municipal Taxation Act, as the same may be amended, replaced or modified from time to time and/or by any other law or legislation;

 

  1.1.28

“Taxes” means, without duplication, all real estate taxes and other taxes, rates, duties, levies, fees, charges and assessments of whatsoever nature and kind (including, without limitation and without duplication, local improvement rates, water rate and service tax, water taxes, school taxes, Surtax, the tax on non-residential immovables and any other tax on non-residential immovables), whether general or special, and whether in existence at the date hereof or hereafter, imposed, assessed, levied or charged by any federal, provincial, municipal, school or other applicable or relevant taxing authority or body, upon or against the Lands, the Building or the Property or any part thereof or upon the Landlord in respect thereof, or from time to time levied or imposed in the future in lieu of or in substitution thereof, or for which the Landlord is liable in respect of the Lands, the Building or the Property and Tax on Capital (as hereinafter defined) assessed against the Landlord and reasonably imputed by the Landlord to be attributable to the Lands, the Building or the Property and any tax on rental income that may be levied by any government or applicable taxing authority except for income taxes, profits taxes, excess profits taxes and capital gains taxes. If the system of taxation is altered or varied from that in force on the

 

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  Commencement Date and any new, additional or replacement tax, rate, duty, levy, fee, charge or assessment shall be levied or imposed on all or any portion of the Lands, the Building or the Property or the revenues therefrom or on the Landlord in substitution for or in addition to Taxes levied or imposed on the Commencement Date then any such new tax or levy shall be deemed to be or to be included in “Taxes”. There shall be excluded from Taxes the Landlord’s business tax, any mutation tax due for any transfer of immovables resulting from the sale of the Property (in whole or in part), any readjustment attributable to a period when the Tenant (or any assignee thereof) was not a tenant of the Leased Premises, any municipal surtax on non-residential immovables which does not relate to the Property, any penalties, interest or other costs resulting from the failure of the Landlord to pay Taxes on time and which do not result from the fault or negligence of the Tenant, and any Taxes imposed upon vacant property which cannot be reasonably attributed to the Property. For the purposes hereof, “Tax on Capital” means any amount of tax or excise imposed by the Province of Quebec or the Government of Canada, including large corporation taxes, upon the Landlord or the owners of the Property based in whole or in part upon the capital, surplus, reserves or indebtedness of the Landlord or owners of the Property, as more precisely defined in the Taxation Act (Quebec) or in the Income Tax Act (Canada) (the “Tax on Capital”);

 

  1.1.29 “Tenant” means the Party of the Second Part and its permitted successors and assigns;

 

  1.1.30 Tenant’s Fit-Up” means the leasehold improvements to be constructed or erected in the Leased Premises or any part thereof by the Landlord at the Tenant’s expense in accordance with the Tenant’s final plans and specifications, the whole as provided in Section 3.2 hereof. The Tenant’s Fit-Up shall not include any specialized equipment of the Tenant which is the responsibility of the Tenant to provide or install, but does include any piece of equipment required by the Tenant and which is to be installed in the Leased Premises as part of the leasehold improvements. The Landlord’s maximum contribution to the Tenant’s Fit-Up is set out in Section 3.3 of this Lease and is defined as the Fit-Up Allowance. Subject to the said contribution by the Landlord of the Fit-Up Allowance, all of the costs of carrying out the Tenant’s Fit-Up shall be borne by the Tenant;

 

  1.1.31 “Tenant’s Leasehold Improvements” means all leasehold improvements made to the Leased Premises which are other than the Landlord’s Work and includes the Tenant’s Fit-Up and the Work;

 

  1.1.32 “Term” means the term of this Lease as specified in Section 5.1 hereof;

 

  1.1.33 “Unavoidable Delay” means any delay by either the Landlord or the Tenant in the performance of their obligations under this Lease caused in whole or in part by any force majeure, act of God, fire, flood, strikes, lockouts or other disturbances, sabotage, war, blockades, insurrections, riots, civil disturbances, inability to obtain materials or equipment, breakage of or accident to machinery, inability of the Landlord to obtain necessary permits, any act, omission or event whether of the kind herein enumerated or otherwise not within the reasonable control of the Landlord or the Tenant, as the case may be, and which by the exercise of due diligence the Landlord or the Tenant, as the case may be, could not have prevented, but lack of funds on the part of the Landlord or the Tenant, as the case may be, shall not constitute an Unavoidable Delay; and

 

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  1.1.34 “Work” has the meaning ascribed to it in Section 13 hereof.

 

  1.2 Schedules - The Schedules of this Lease are a part of it and consist of:

 

  1.2.1 Schedule “A” - Description of Property and Leased Premises composed of:

 

  a) Schedule “A-l” - Legal Description of the Lands and the Building;

 

  b) Schedule “A-2” - Plan showing the Property (Phase 2 of Technoparc Saint- Laurent) and the approximate location of the Building on the Property;

 

  c) Schedule “A-3” - Plan showing the Leased Premises;

 

  1.2.2 Schedule “Bl” - Description of Landlord’s Work: Base Building Leasehold Improvements (Specifications);

 

  1.2.3 Schedule “C” - Copy of Bylaw 1160-1 of the City of Saint-Laurent;

 

  1.2.4 Schedule “D” - Rules and Regulations;

 

  1.2.5 Schedule “E” - Additional Clauses

 

  1.2,6 Schedule “F” - Technoparc Servitude;

 

  1.2.7 Schedule “G” - Certified copy of Resolution of Tenant;

 

  1.2.8 Schedule “H” - Form of Irrevocable Transferable Letter of Credit;

 

  1.2.9 Schedule “I” - Environmental Questionnaire; and

 

  1.2.10 Schedule “J” - Manual Procedure for Cleaning.

 

  1.3 Headings - The headings, captions, section numbers, article numbers and table of contents appearing in this Lease are inserted only as a matter of convenience and in no way define, limit, construe or describe the scope or intent of such sections or articles of this Lease nor in any way affect this Lease.

 

  1.4 Interpretation - Interpretation of the words “hereof”, “herein”, “hereunder” and similar expressions used in any section or subsection of this Lease relate to the whole of this Lease and not to that section or subsection only, unless otherwise expressly provided. Where required by the context hereof, words importing the singular number only shall include the plural and vice versa, and words importing the neuter gender shall include the feminine or masculine gender and vice versa, and words importing persons shall include firms and corporations. All units of currency are expressed herein in Canadian Dollars.

 

  1.5 Net Lease - It is the intent of the parties hereto that this Lease shall be absolutely net to the Landlord and, except as expressly set out herein, the Landlord shall not be responsible during the Term for any costs, charges, taxes, expenses and outlays of any nature whatsoever arising from or relating to the operation, maintenance, repair, management and administration and any other related operating cost of the Leased Premises, or the use and occupancy thereof, or the contents thereof or the business carried on therein, and the Tenant shall alone, to the complete

 

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exoneration of the Landlord, be responsible for and pay all charges, impositions, maintenance, repair, management and administration and any other related operating costs of the Leased Premises, (including without limitation Taxes) and its Proportionate Share of all charges, impositions, costs and expenses of every nature and kind relating to the Building and Lands. In addition, but without duplication, the Tenant shall pay a share of all charges, impositions, costs and expenses of every nature and kind, (including Taxes) relating to the operation, maintenance, repair, management and administration and any other related operating cost of the Common Areas and Facilities (including the parking) of the Property (being Phase 2 of Technoparc Saint-Laurent), in which the Building is located. The Landlord shall apportion such charges, impositions, costs and expenses (including Taxes) relating to the Common Areas and Facilities of the Property among the buildings forming Phase 2 of Technoparc Saint-Laurent, including the Building, and the Tenant shall pay its Proportionate Share of the same. Any amount and any obligation that is not expressly declared herein to be that of the Landlord at its expense shall be deemed to be the obligation of the Tenant to be performed by and at the expense of the Tenant.

 

2. LEASED PREMISES

 

 

2.1

Description of the Leased Premises - The Landlord hereby leases to the Tenant and the Tenant hereby leases from the Landlord, upon the terms and conditions herein contained, the Leased Premises which shall consist of a self-contained unit to be located in the Building to be erected and to contain two (2) units (the Leased Premises constituting one of such units) and which Leased Premises are substantially as shown on Schedule “A-3” attached hereto. The approximate location of the Building on the Property is shown outlined in red on the plan attached hereto as Schedule “A-2”. The Tenant acknowledges that Schedules “A-2” and “A-3” are for the sole purpose of indicating the approximate location and form of the Leased Premises and the Building and that, notwithstanding anything to the contrary contained in this Lease or the provisions of the Civil Code of Quebec, the Landlord may make minor variations to the form and siting of the Leased Premises or any part thereof. The Leased Premises will be located on the second (2 nd ) floor of the Building and will have a civic address at 7170 Frederick-Banting Street, in the City of Saint-Laurent, Province of Quebec.

 

  2.2 Rentable Area of the Leased Premises - The Rentable Area of the Leased Premises, which is estimated to be ten thousand two hundred and twenty square feet (10,220 sq. ft.) and the usable area of the Leased Premises has been determined by the Architect in accordance with Subsection 1.1.23 and certified by the Architect and an architect’s certificate to such effect will be delivered to the Tenant within thirty (30) days after the Leased Premises are substantially completed as certified by the Landlord’s Architect. The Architect’s certificate is final and binding on the parties. Any change in the final determination of the Rentable Area of the Leased Premises shall be reflected by a corresponding increase or decrease in the calculation of all amounts due under this Lease, whose calculation is determined in accordance with the Rentable Area of the Leased Premises, including, without limitation, Basic Minimum Rent and Additional Rent. It is understood that the annual net basic rental rates per square foot enumerated in Article 7 hereof shall remain unchanged.

 

3. LANDLORD’S WORK AND TENANT’S FIT-UP

 

  3.1 Landlord’s Work - The Landlord shall at its sole cost and expense perform the Landlord’s Work (which, for greater certainty, includes all the base systems described in Schedule “B-1”), as specified in Schedule “B-l” annexed hereto. All Landlord’s Work shall be completed in a good and workmanlike manner in accordance with the standards of the buildings built by Societe Immobiliere Technologique de Montreal Inc. in Technoparc Saint-Laurent and shall comply with the Building plans and specifications provided to the Tenant (attached hereto as Schedule “B-l”) and all building codes and applicable legislation in force at the time of delivery of the Leased Premises, including the master plan for the City of Saint-Laurent.

 

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  3.1A Construction Permits and Initial Installations - The Landlord hereby agrees that it shall retain, a project engineer for the carrying out of the Landlord’s Work, (the “Project Engineer”) who shall be designated by the Landlord. The Landlord shall be responsible for the payment of the Project Engineer’s fees but only insofar as such fees are incurred in respect of advising the Landlord on carrying out the Landlord’s Work. All other fees of the Project Engineer, including, without limitation, those pertaining to the Tenant’s Fit-Up, shall be for the account of the Tenant. With regard to the Tenant’s Fit-Up, the Tenant shall have the right to retain the services of its own project engineer or other professional of its choice but subject to the approval of the Landlord (such approval not to be unreasonably withheld), the whole at the Tenant’s own cost.

The Landlord will be responsible to prepare all construction plans and final specifications for the Landlord’s Work described in Schedule “B-l”. The Landlord will also be responsible to carry out soil tests, as it determines necessary, for the Lands on which the Building is to be situated and to make such modifications as may be required to Schedule “B-l” as a result of such soil tests, including, if any, to respect the warranty of the Landlord in respect of environmental matters set out in the fourth paragraph of Section 18.3 hereof. If modifications are required to be made to the soil, such as for example, compaction of the soil, the Tenant shall not incur any additional costs as result thereof and the Landlord’s obligations under Schedule “B-l” hereof shall not be diminished.

The Landlord shall install and pay for the installation and connection (excluding connection to the Tenant’s equipment) of services as specified in Schedule “B-l” annexed hereto, which are required for the Leased Premises as at the Delivery Date. For greater certainty, such services do not include gas and only include those in respect of electricity and water (including all related excavation and filling) as specified in Schedule “B-l”. In addition, the Landlord, at its cost, shall construct and complete the parking areas, driveways and landscaping.

The Landlord acknowledges that it will be responsible to obtain all permits or authorizations required from governmental authorities for the construction of the Building in conformity with provisions of Schedule “B-l” annexed hereto. The installation and the hook-up of the electrical services and water for the Building (excluding any hook-ups required for the Tenant’s equipment) will be carried by the Landlord, at its cost, before the end of the Landlord’s Work, the whole in accordance with applicable laws. It is agreed that the Landlord is not responsible for the installation of any services for natural gas, it being agreed however that the Tenant can request such a hook-up if it requires the same from the supplier of natural gas, the whole at its cost and in accordance with required laws and safety standards.

Except to the extent the same are due to the fault or negligence of the Tenant, the Landlord will be responsible to pay any damages, fines or penalties which may be imposed or incurred by the Landlord if the Landlord’s Work does not respect applicable legislation which is in place at the date that the Building is substantially completed, including any regulation or building code then in force at such time.

All other leasehold improvements required by the Tenant or to be made to the Leased Premises shall be supplied and installed at the Tenant’s expense shall be subject to the provisions of Article 13 hereof (except for the Tenant’s Fit-Up), and shall be considered Tenant’s Leasehold Improvements.

 

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  3.2 Tenant’s Fit-Up -The Landlord will also be responsible to carry out the construction of the Tenant’s improvements in accordance with the Tenant’s final plans and specifications which will be prepared and produced by the Tenant’s designer, who is retained solely at the cost of the Tenant (the “Designer”). Subject to the contribution by the Landlord of the Fit-Up Allowance (as hereinafter referred to), all costs of carrying out the Tenant’s leasehold improvements in accordance with the Tenant’s final plans and specifications (the “Tenant’s Fit-Up”) shall be borne by the Tenant.

 

  3.2A Tenant’s Telecommunications Antenna - Subject to the following conditions, the Tenant shall have the right to install one (1) satellite antenna (not to exceed six feet (6’) in diameter) on the exterior of the Building and in connection therewith, required cabling. Such right to install said antenna and cabling is subject to the following conditions:

 

  (i) such antenna and cabling shall be located only in such place as specified by the Landlord and shall be installed under the supervision and subject to the specific instructions of the Landlord and its workmen;

 

  (ii) such antenna and cabling shall be used only for the personal use of the Tenant and shall not be exploited commercially nor used for any other purpose whatsoever. For greater certainty, the Tenant shall not be entitled to lease or otherwise license or permit the use of such antenna and cabling by any other person. The Tenant shall be entitled to use in respect of the operation of such antenna, the service provider of its choice;

 

  (iii) the use, size, location, etc. of such antenna and cabling must comply with all applicable laws, by-laws and regulations, municipal, provincial, federal or otherwise including, without limitation, the airport zoning regulations and requirements;

 

  (iv) such antenna and cabling shall be maintained at the sole cost and expense of the Tenant and the Tenant hereby agrees to maintain the same in good and workmanlike manner. In addition, such antenna and cabling shall be removed at the Tenant’s sole cost and expense at the expiration of the Term (or any renewal thereof) or earlier termination of the Lease under the supervision of the Landlord and its workmen and the Tenant shall be responsible to pay the costs of any repair necessitated to the Building or otherwise caused by such installation and removal.

 

  3.3 Landlord’s Contribution to Tenant’s Fit-Up - The Landlord agrees to contribute towards the costs of the Tenant’s Fit-Up a sum equal to Forty Dollars ($40.00) per square foot of the Rentable Area of the Leased Premises (the “Fit-up Allowance”). The Fit-Up Allowance may be applied to related costs to modify and/or add to the Landlord’s standard office building (that is the base building leasehold improvements), any and all direct leasehold improvements and related soft costs, including without limitation the general contractor fees and the five percent (5%) developer general administrative fee which the Tenant hereby agrees is payable to the Landlord (said five percent (5%) shall be calculated on the basis of five percent (5%) of all hard costs and professional costs for the Tenant’s Fit-Up). Any amount attributable to the Goods and Services Tax or to any other similar tax shall be added to the Fit-up Allowance and paid by the Landlord.

 

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Any equipment or improvement changes not provided for in the base building standards as set out in Schedule “B-l”, and which result from changes related to the Tenant’s Fit-Up (such changes having been approved by both the Landlord and the Tenant), will be the object of an increase of the costs payable by the Tenant and consequently, these costs will be added to the costs of the Tenant’s Fit-Up.

The costs of all professionals engaged by the Tenant will be the sole responsibility of the Tenant (save to the extent as provided above in respect of the Project Engineer). In addition the cost of preliminary plans and final working drawings for the Tenant’s Fit-Up shall be borne by the Tenant.

The Fit-Up Allowance shall be applied to the cost of the Tenant’s Fit-Up (as described below) and related costs as aforesaid and shall be paid progressively, and proportionately to the total amount of the budget for the Tenant’s Fit-Up, to the general contractor or other suppliers of materials or work based upon the Landlord’s architect’s certificates. It is agreed that the progressive payments to be made in respect of work carried out for the Tenant’s Fit-Up must be approved by the Landlord, the Landlord’s Architect and the Tenant’s representative who supervises the Tenant’s Fit-Up. In the event of any dispute concerning the making of any such payment, the decision of the Landlord’s Architect shall be final and binding. The Tenant must, however, respect the construction timetable of the general contractor and of the Landlord in providing authorizations. The aforesaid construction timetable was submitted to the Tenant on or before March 10, 2002.

 

  3.4 Funds for Excess Costs for Tenant’s Fit-Up - As indicated in Section 3.2 hereof, the Tenant shall be responsible for all costs to complete the Tenant’s Fit-Up. To cover the costs of the Tenant’s Fit-Up over and above the Fit-Up Allowance, the Tenant has supplied to the Landlord funds in the amount of Six Hundred Thousand Four Hundred and Thirty Dollars and Fifty Cents ($600,430.50), being the amount estimated to be equal to the difference between the cost as estimated by the Landlord for the Tenants Fit-Up, as set forth in Section 3.5 below, and the amount of the Fit-Up Allowance. Upon the Landlord receiving any invoice from the suppliers, subcontractors and/or the general contractor or any other person in respect of any costs for the Tenant’s Fit-Up, the Landlord shall transmit to the Tenant an invoice indicating that portion of the invoice which the Tenant is required to pay and such amount shall be paid from the abovementioned funds provided by the Tenant. If the costs of such invoices exceeds the said amount of Six Hundred Thousand Four Hundred and Thirty Dollars and Fifty Cents ($600,430.50), the Tenant undertakes to remit to the Landlord amounts necessary to cover the cost of such invoices within ten (10) Business Days of the receipt of such invoice plus any and all of the direct leasehold improvements and related soft costs described above.

 

  3.5 Final Plans and Specifications for Tenant’s Fit-Up - The Tenant has supplied at its cost to the Landlord on or before January 25, 2002, final plans and specifications for the Tenant’s Fit-Up. Within ten (10) days of receipt of such final plans and specifications, the Landlord shall provided to the Tenant a written estimate of the costs to complete the Tenant’s Fit-Up. Said estimate was as precise as possible, however, it is fully recognized by the Tenant that it was prepared for budget purposes only and is not binding upon the Landlord.

Whenever possible without causing delay to the delivery schedule, the Landlord shall obtain a minimum of three (3) tenders after going through a bidding procedure (Notwithstanding the foregoing, the Landlord shall not be required to obtain tenders for work for the HVAC system nor for the underground plumbing). The tenders and tenderers shall be chosen by the general contractor and the Landlord, after consultation and agreement with the Tenant, acting reasonably. Said tenders shall be addressed to the Tenant and Landlord and every decision

 

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related to such shall be taken by the Landlord with the Tenant’s written consent. The Tenant or its representative must be present at the opening of any tender and at every construction meeting.

The Landlord shall meet with the Tenant not less than monthly to review the progress of construction and any other matters which either the Landlord or Tenant wishes to raise. The Tenant will receive a copy of all minutes of such meetings, a copy of all change orders (those pertaining to the Tenant’s Fit-Up must be approved by the Tenant) and a copy of any price change pertaining to such changes. The Tenant may nominate a representative at its cost to supervise the Tenant’s Fit-Up but the administration of carrying out the Tenant’s Fit-Up shall remain the responsibility of the Landlord and the general contractor. Any delay caused in carrying out the Tenant’s Fit-Up caused by such a representative will be considered as if a delay caused by the Tenant.

The Tenant maintains the right to make minor changes to the plans and specifications for the Tenant’s Fit-Up, after approval of the same, subject to the Landlord’s written consent and provided that it does not delay the construction of the improvements in the Landlord’s reasonable opinion to a point where it jeopardizes the delivery of the Leased Premises expected on May 1, 2002. When the tendering process is not possible due to delays in the delivery schedule, the Landlord will inform the Tenant’s representative of its construction process and will cooperate with the Tenant in determining acceptable construction costs. The Tenant hereby confirms that its representative for giving authorizations or approvals for the Tenant in order that the Landlord may proceed with the completion of construction of the Leased Premises and for attending meetings shall be Ms. Dalal Manoli President and Chief Executive Officer of Phagetech Inc. C.P. 387, Place du Parc, Montreal, Quebec H2W 2N9, telephone (514) 282-0990, fax (514) 282-9889. The Tenant acknowledges that the decision of Ms. Dalal Manoli shall bind the Tenant.

 

  3.6 General Contractor - The Landlord, in collaboration with the Tenant, will supervise the leasehold improvements related to the Tenant’s Fit-Up. The work will be carried out by the general contractor retained by the Landlord to construct the Building and the Leased Premises. The Landlord arranged for the construction contract entered into with the general contractor to provide for a fixed price, on the condition that no changes were or are requested to the work to be carried out by the general contractor under such construction contract following approval by the Landlord of the Tenant’s final plans and specifications. If changes were or are requested, then the general contractor has provided or shall provide a specific price for each such change requested. However, in no event shall the Landlord have any responsibility whatsoever to ensure the fixed price is met and makes no guarantee or warranty whatsoever in respect of the costs of the construction.

 

  3.7 Changes to Landlord’s Work or Tenant’s Fit-Up - The Landlord and the Tenant acknowledge that any changes the Tenant requests to the Landlord’s Work or Tenant’s Fit-Up may result in a delay of the Delivery Date and in an increase in the amount required to complete the Landlord’s Work or Tenant’s Fit-Up, for which the Tenant shall be solely responsible. The Tenant shall forthwith pay to the Landlord, upon receipt of an invoice for same, all such increased costs. The Landlord shall advise the Tenant in writing, upon being so advised by its general contractor and/or the Landlord’s applicable professionals, of the number of days of delay in construction any such changes would cause and an estimate of the increase in the cost, if any. No such changes may be requested by the Tenant if they would affect the base building or the quality of the Building or result in penalties or other similar payments being required to be paid by the Landlord in respect of materials and/or equipment and/or services unless, in the latter case, the Tenant agrees to pay in advance in cash to the Landlord such penalties or other similar payments.

 

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4. OCCUPANCY AND DELIVERY DATE

 

  4.1 Occupancy Prior to Commencement Date - Subject to Unavoidable Delay (as defined in Section 4.4 hereof), it is anticipated that the leasehold improvements to be made by the Landlord to the Leased Premises will be substantially completed by May 1, 2002. If such leasehold improvements to the Leased Premises are substantially completed before May 1, 2002 (the “Delivery Date”), the Tenant shall have the right to occupy the Leased Premises upon such substantial completion of the leasehold improvements and until the Commencement Date (the “Interim Occupancy Period”) and during such Interim Occupancy Period, no Basic Minimum Rent shall be payable prior to the Commencement Date. However, the Tenant shall be required to pay during the Interim Occupancy Period, Additional Rent and all other costs pertaining to the Leased Premises and its use thereof, including, without limitation, Operating Costs, Taxes, water, electricity, utility and other costs and the costs of all special services provided to it by the Landlord, including, without limitation, extra security services which may be required due to the Tenant taking occupancy prior to the Commencement Date and all amounts payable by the Landlord to third party contractors as a result of the Tenant’s early occupancy. All the terms of the Lease shall apply mutatis mutandis prior to the Commencement Date. The Tenant shall be liable for any and all damages caused by its actions or omissions or those of its contractors, subcontractors, agents, employees and other persons for whom the Tenant is responsible at law for whom the Tenant is responsible at law.

 

  4.2 Delivery of Leased Premises - Subject to Unavoidable Delay (as hereinafter defined in Section 4.4 hereof) and any reasons attributable to the Tenant, including without limitation, any changes requested to the Landlord’s Work by the Tenant as contemplated in this Lease and any delay due to the installation of the generator or UPS unities referred to in Section 8.3A hereof, the Landlord shall deliver possession of the Leased Premises to the Tenant substantially completed with the Landlord’s Work as set forth in Schedules “Bl” (said Schedule “B-1” work shall be in accordance with applicable laws then in force at the time of the Delivery Date and will be carried out using new materials) and the Tenant’s Fit-Up as per the Tenant’s final plans and specifications (as approved by the Landlord), the whole as certified by the Landlord’s Architect, on or before the Delivery Date. For the purposes hereof, “substantial completion” shall mean that the Leased Premises are sufficiently completed to enable the Tenant to install its equipment and furniture for purposes of commencing its activities in the Leased Premises (without limiting the generality of the foregoing, all mechanical and electrical systems will be completed and operational, all walls will be erected and painted).

Upon the Landlord delivering possession of the Leased Premises to the Tenant as set out in this Section 4.2, the Tenant shall have the right to verify that the Landlord’s Work and the Tenant’s Fit-Up are complete and the Tenant shall have thirty (30) days from the date possession is given to it to inspect the Leased Premises and provide the Landlord with a list of deficiencies within thirty (30) days with respect to the Landlord’s Work and the Tenant’s Fit-Up, failing which the Tenant shall be deemed to have accepted the Leased Premises. If the Tenant delivers up a list of deficiencies as aforesaid and provided that the Landlord, acting reasonably, is in agreement with such list, the Landlord shall remedy such deficiencies within a reasonable time and in good and workmanlike manner. If the Landlord fails to remedy such deficiencies within a reasonable time, the Tenant, after giving the Landlord a prior written notice of not less than thirty (30) days and provided that the Landlord fails within such thirty (30) day period to commence to remedy the same, may, acting reasonably, repair such deficiencies and the Landlord shall reimburse the Tenant for all reasonable direct out-of-pocket expenses incurred to repair such deficiencies.

 

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Concerning the HVAC, the thirty (30) day delay for the Tenant to inspect said system will only commence when the system is started up as confirmed by the Landlord to the Tenant.

The above provisions shall not diminish any guarantee from suppliers or professionals who were retained by the Landlord and which guarantee was given to the Landlord in reference to the construction of the Landlord’s Work or the Tenant’s Fit-Up.

 

  4.3 Delay in Delivery of Leased Premises - If due to reasons attributable to the Landlord or to Unavoidable Delay but not due to reasons attributable to the Tenant (including any event of Unavoidable Delay attributable to the Tenant), the Leased Premises are not substantially completed as provided in Section 4.2 of the Lease by the Delivery Date and as a result possession of the Leased Premises is given to the Tenant later than the Delivery Date, the Commencement Date of the Lease and termination date, and all other dates and delays stipulated herein will be moved forward by the same number of days as the delay in giving possession.

The Tenant shall not be entitled to any damages or indemnity whatsoever resulting from such delay and agrees to accept any extension provided as aforesaid, as full and final settlement of any and all claims which the Tenant may otherwise have by reason of any delay in delivering possession of the Leased Premises. Any delay in delivering possession of the Leased Premises due to reasons attributable to the Tenant (including any event of Unavoidable Delay attributable to the Tenant), shall not entail extension of the Commencement Date or termination date of the Lease nor entitle the Tenant to any compensation whatsoever.

 

  4.4 Unavoidable Delay - For the purposes of this Article 4 only, Unavoidable Delay shall mean any delay of the Landlord in the performance of its obligation) under this Lease caused in whole or in part by any force majeure, act of God, flood, strikes, lock-outs or other industrial disturbances, sabotage, war, blockades, insurrections, riots, civil disturbances, breakage of or accident to machinery, inability to obtain materials or equipment, inability of the Landlord to obtain necessary permits, any act, omission or event whether of the kind herein enumerated or otherwise not within the reasonable control of the Landlord and which by the exercise of due diligence the Landlord could not have prevented, but lack of funds or increased cost of funds on the part of the Landlord shall not constitute a cause for an Unavoidable Delay. For greater certainty, if the failure of the Landlord to deliver possession of the Leased Premises to the Tenant on or by the Delivery Date is attributable to the Tenant (including, by way of example but without limitation, any changes to the Landlord’s Work or Tenant’s Fit-Up as contemplated by Article 3 hereof, or any other changes to plans or equipment requested by the Tenant or its consultants and any delay or failure by the Tenant to approve the budget or the revised budget, as the case may be, within the delay contemplated in Section 3.5 or to supply its final plans and specifications to the Landlord as provided in Section 3.5), the Landlord shall not be in default hereunder and the time for delivery of possession shall be extended by the number of days in the delay so caused by the Tenant (such extension to be determined by the Landlord and its professionals, acting reasonably) and there shall be no extension of the Commencement Date of the Lease.

 

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Each of the Landlord and Tenant acknowledges that the construction of the Leased Premises will be proceeding on an accelerated basis in order to achieve the Delivery Date of May 1, 2002. Consequently, each of the Landlord and Tenant agrees to provide full and timely cooperation with each other in order to ensure that all decisions are made, approvals obtained and commitments entered into as soon as possible so as to facilitate the Delivery Date.

 

  4.5 Notification - Construction of Leased Premises - Any request for information or positive act required from the Tenant in order for the Landlord to complete the construction of the Leased Premises within the time periods specified herein (as the same may be extended in accordance with the terms hereof) shall be in writing (which notice may be given by facsimile) and shall be given to the Tenant’s representative designated in Section 3.5 of this Lease and the decision of such person shall be binding on the Tenant.

 

5. TERM OF LEASE

 

  5.1 Term of the Lease - The term of the Lease, unless sooner terminated pursuant to the provisions hereof, shall be for a period of ten (10) years commencing, subject to the provisions of this Lease, on May 1st, 2002 and terminating on April 30th, 2012.

 

  5.2 Commencement Date - Subject to the foregoing the Commencement Date shall be May 1st, 2002.

 

  5.3 Landlord’s Access to the Leased Premises - Notwithstanding the occupancy of the Leased Premises by the Tenant on or before the commencement of the Term, the Tenant agrees that the Landlord and its authorized representatives, workmen and subcontractors shall have access to the Leased Premises in order to complete the Landlord’s Work and the Tenant’s Fit-Up (if any) to the Leased Premises.

 

6. USE OF LEASED PREMISES

 

  6.1 Use of the Leased Premises - The Leased Premises shall be used and occupied by the Tenant throughout the Term solely for general office purposes, and research and development laboratories, the whole in conformity with all applicable laws, bylaws, regulations and other legislation and the Technoparc Servitude (a copy of which is annexed hereto as Schedule “E”) and for no other purpose. No outside storage is permitted on any part of the Property. The Tenant specifically acknowledges that the Leased Premises and the Building shall form part of a technological research and development park and consequently are subject to special use and building restrictions and a master plan and other regulations and bylaws adopted by the City of Saint-Laurent from time to time and that such restrictions include without limitation the obligation of the Tenant to carry out research and development activities in the Leased Premises. The Tenant agrees to comply with the requirements of the master plan, the Technoparc Servitude and all other regulations and bylaws as adopted from time to time by applicable government authorities. Furthermore, the Tenant agrees not to use or permit the use of the Leased Premises for any use prohibited by Section 6.2 hereof. The Tenant shall be solely responsible for ensuring that the use it intends to make of the Leased Premises and the activities to be conducted therein, comply with all laws, bylaws, regulations and other legislation applicable to the Property.

 

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  6.2 Prohibited Use - Notwithstanding the provisions of Section 6.1 hereof, the Tenant shall not carry on any business nor use, permit or suffer the use of the Leased Premises, or any part thereof, for any activity which because of its quality or operation, would in the Landlord’s opinion, based on the Technoparc Saint-Laurent criteria, tend to lower the character of the Building or the Property, any illegal, unethical or fraudulent practice nor carry on any business which shall be a nuisance in the Leased Premises or anything which may constitute a disturbance of enjoyment of other tenants or occupants of the Building or cause noise, disturbance or noxious odours to the discomfort of other tenants or neighbours nor do or suffer any waste or damage, disfiguration or injury to the Leased Premises, the Building or the Property nor permit any overloading of the floors which would endanger the structure of the Building. The Tenant may not hold the Landlord in any way responsible for any damages or annoyance which the Tenant may sustain through the fault or actions of any other tenant or occupant of the Building and, subject to the Landlord’s obligation to provide the Tenant with peaceful enjoyment of the Leased Premises as provided in Section 28 hereof, the Tenant specifically renounces to any claims and recourses it may have or acquire against the Landlord under Articles 1859 and 1861 of the Civil Code of Quebec.

 

  6.3 First Class Technology Park - The Landlord agrees that it will maintain the Building and the Property as part of a first class technology park in the City of Saint-Laurent and the Tenant agrees to use the Leased Premises and to carry out all of its activities in such a manner as is consistent with and in order to permit the Landlord to maintain such a first class technology park.

 

  6.4 Window Coverings - The Tenant shall not install drapes or curtains on any window in the Leased Premises. Any other window covering shall only be permitted if the same complies with the Landlord’s scheme of building standard window coverings for the windows of the Building and is consistent with the architects’ general design criteria for the Technoparc Saint-Laurent.

 

  6.5 Dangerous Materials - The Tenant shall not bring into, or store in the Leased Premises any inflammable liquid or dangerous or explosive materials, solvents or other chemicals, other than those chemicals which are normally used in association with office photocopy and equipment or office computer printing equipment and are required by the Tenant for such purpose or those which are necessary for the Tenant’s normal activities in the Leased Premises, provided that such inflammable liquid or dangerous or explosive materials, solvents or other chemicals are described and disclosed in the Environmental Questionnaire to be completed in accordance with Section 18.2 hereof and provided further that the Tenant complies with all applicable laws, bylaws, regulations and other legislation applicable thereto. In addition, the Tenant shall not bring into, or store in the Leased Premises any other matter which may be considered as a pollutant or contaminant or hazardous product or waste under any applicable environmental protection legislation, unless the Tenant complies with the provisions of Section 18.2 hereof. The Tenant shall indemnify and hold the Landlord harmless from all losses, liabilities, damages, costs, expenses and claims of any kind whatsoever resulting from any breach of the foregoing obligation, including, without limitation, any seepage, spillage, discharge and misuse of any cleaner, solvent, chemical, pollutant, contaminant or hazardous product and waste, and hereby undertakes to immediately repair any such damage at its expense and to restore the Leased Premises, the Building and/or the Lands or any portion thereof, damaged by such seepage, spillage, discharge, misuse, storage or other cause, to their original condition, lessen ordinary wear and tear.

 

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  6.6 Continuous Operation - Subject to the provisions of Section 5 of Schedule “E” hereto, the Tenant shall occupy the Leased Premises throughout the Term and shall conduct continuously and actively in the whole of the Leased Premises, its business as permitted by Section 6.1 hereof. The Tenant acknowledges that its continued occupancy of the Leased Premises and the continuous and active conduct of its business in the Leased Premises are of the upmost importance to the Landlord in avoiding the appearance and impression generally created by vacant space and in facilitating the leasing of vacant space in the Building and in the Technoparc Saint-Laurent and maintaining the quality and character of the Building and the Technoparc Saint-Laurent. The Tenant also acknowledges that the Landlord will suffer substantial damage and serious irreparable injury if the Leased Premises are left vacant or are abandoned during the Term even in the event the Tenant pays all rent required hereunder.

 

7. BASIC MINIMUM RENT, ADMINISTRATIVE FEES AND PAYMENT OF RENT

 

  7.1 Basic Minimum Rent - The Tenant shall pay Basic Minimum Rent comprised as follows:

 

  7.1.1 for the period commencing on May 1st, 2002 and terminating on April 30th, 2003, a sum equivalent to Nineteen Dollars ($19.00) per square foot of Rentable Area of the Leased Premises;

 

 

7.1.2

for the period commencing on May l st , 2003 and terminating on April 30th, 2004, a sum equivalent to Nineteen Dollars and Thirty Eight Cents ($19.38) per square foot of Rentable Area of the Leased Premises;

 

  7.1.3 for the period commencing on May 1st, 2004 and terminating on April 30th, 2005, a sum equivalent to Nineteen Dollars and Seventy Seven Cents ($19.77) per square foot of Rentable Area of the Leased Premises;

 

  7.1.4 for the period commencing on May 1st, 2005 and terminating on April 30th, 2006, a sum equivalent to Twenty Dollars and Seventeen Cents ($20.17) per square foot of Rentable Area of the Leased Premises;

 

  7.1.5 for the period commencing on May 1st, 2006 and terminating on April 30th, 2007, a sum equivalent to Twenty Dollars and Fifty Seven Cents ($20.57) per square foot of Rentable Area of the Leased Premises;

 

  7.1.6 for the period commencing on May 1st, 2007 and terminating on April 30th, 2008, a sum equivalent to Twenty Dollars and Ninety Eight Cents ($20.98) per square foot of Rentable Area of the Leased Premises;

 

  7.1.7 for the period commencing on May 1st, 2008 and terminating on April 30th, 2009, a sum equivalent to Twenty One Dollars and Forty Cents ($21.40) per square foot of Rentable Area of the Leased Premises;

 

  7.1.8 for the period commencing on May 1st, 2009 and terminating on April 30th, 2010, a sum equivalent to Twenty One Dollars and Eighty Three Cents ($21.83) per square foot of Rentable Area of the Leased Premises;

 

  7.1.9 for the period commencing on May 1st, 2010 and terminating on April 30th, 2011, a sum equivalent to Twenty Two Dollars and Twenty Seven Cents ($22.27) per square foot of Rentable Area of the Leased Premises; and

 

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  7.1.10 for the period commencing on May 1st, 2011 and terminating on April 30th, 2012, a sum equivalent to Twenty Two Dollars and Seventy Five Cents ($22.75) per square foot of Rentable Area of the Leased Premises.

 

  7.2 [Intentionally Deleted]

 

  7.3 Payment of Rent - All Rent shall be payable in equal consecutive monthly installments on the first (1st) day of each and every month during the Term, in lawful money of Canada, without any prior demand therefor and without any set-off, deduction, abatement or compensation and shall be paid to the Landlord or, as it may in writing direct, to its nominee at the office of the Landlord, located at 7150 Albert-Einstein, Suite 200, Saint-Laurent, Quebec, H4S 2C1, or at such other place in Canada as the Landlord may from time to time designate in writing to the Tenant. If the Commencement Date is on a day other than the first day of a calendar month, the Tenant shall pay, on the Commencement Date, the Rent prorated on a per diem basis from and including the Commencement Date to and including the last day of the month in which the Commencement Date occurs, based upon a period of three hundred and sixty-five (365) days.

 

  7.4 Postdated Cheques or Pre-authorized Payments - Upon the Landlord’s request, the Tenant hereby agrees to present to the Landlord at the beginning of each Rental Year throughout the Term a series of monthly postdated cheques or pre-authorized payment forms authorizing the Landlord to make automatic withdrawals from the Tenant’s bank account for the following Rental Year in amounts conforming with the monthly Basic Minimum Rent payments plus monthly Additional Rent payments in respect of which the Landlord has provided estimates to the Tenant.

 

8. ADDITIONAL RENT

 

  8.1 Taxes

 

  8.1.1 As Additional Rent in each and every Rental Year during the Term, the Tenant shall pay, within thirty (30) days of receipt from the Landlord of a written statement and invoice of Taxes, all Taxes imposed upon or allocated to the Leased Premises, its Proportionate Share of Taxes imposed upon or allocated to the Building and the Lands and its Proportionate Share of the Building Share of Taxes imposed upon or allocated to the Property. Without limiting the foregoing, the Tenant specifically acknowledges that its Proportionate Share of the Surtax or the tax on non-residential immovables shall be payable within thirty (30) days of receipt from the Landlord of an invoice for such amount. The Tenant’s Proportionate Share of Taxes in respect of the first and last Rental Years of the Term shall be adjusted between the Landlord and the Tenant on the basis set forth in Section 8.9 hereof.

Provided that the use of the Leased Premises by the Tenant respects the various provisions and criteria set out in the Technoparc Servitude and provided that the criteria set out in By-law Number 1160-1 are respected, the Landlord warrants that the Building (but not the Lands) will qualify for certain real estate tax credits (including the tax on non-residential immovables but excluding local improvement taxes), the whole in accordance with By-law number 1160-1 of the City of Saint-Laurent, a copy of which is annexed hereto as Schedule “C”. Provided further that the criteria set out in By-law number 1160-1 and in the Technoparc Servitude are respected by the Tenant, the Landlord undertakes to apply to the City of Saint- Laurent

 

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for such available real estate tax credits and when such tax credits are granted, to apply the same, to the extent they relate to the Building, in reduction of those real estate taxes forming part of Taxes for the Building for which such credits are given.

The Landlord represents and warrants that it has fulfilled and will continue to fulfill its obligations as provided in Articles 4.5 and 4.6 of By-law number 1160-1 of the City of Saint-Laurent and it will respect the delay for application stipulated in Article 4.6 of the By-law number 1160-1 and any other obligation which may fall upon it as owner of the Lands to permit the granting of the tax credits for such real estate taxes.

It is understood that the Tenant shall not be obliged to pay Tax on Capital as part of Operating Costs or Taxes, for so long as the Landlord is not required to pay Tax on Capital. However, if at any time the Landlord becomes subject to such Tax on Capital and is required to pay the same, the Tenant shall be obliged to pay for the same as part of Operating Costs or Taxes. In such a case, the Tax on Capital shall be calculated as though the Building is the Landlord’s sole property in the Province of Quebec.

 

  8.1.2 The Landlord shall have the right, but not the obligation, to object to, appeal, or contest the levying or imposition of Taxes at any time or any valuation imposed with respect thereto and the Landlord may settle, compromise, consent to, waive or otherwise determine, in its sole discretion, all matters and things relating thereto without notice to, consent or approval of the Tenant. The Tenant shall pay to the Landlord, within thirty (30) days after demand therefor by the Landlord, as Additional Rent, its Proportionate Share of any expenses, including legal, appraisal, administration and overhead expenses incurred by the Landlord in obtaining or attempting to obtain a reduction of any Taxes. If, as a result of such proceedings taken by the Landlord in respect of Taxes, Taxes are increased, the Tenant shall be responsible for its Proportionate Share of any such increase. If, as a result of such proceedings taken by the Landlord in respect of Taxes, Taxes are decreased, the Tenant shall be entitled to share proportionately in the benefit of such decrease. Subject to the foregoing, nothing set forth in this Subsection 8.1.2 shall relieve the Tenant from its obligation to pay its Proportionate Share of Taxes and all expenses and costs incurred in connection with the contestation thereof.

 

  8.1.3 The Tenant shall not be entitled to contest, appeal, object to or litigate the levying or imposition of Taxes.

 

  8.2

Water and Business Taxes and Licence Fees - As Additional Rent and to the complete exoneration of the Landlord, the Tenant shall be liable for, and pay to the competent authority having jurisdiction within the time period provided for such payment by such authority, all water taxes and business taxes, garbage taxes and all taxes, rates, duties, levies, assessments and other charges of whatsoever nature and kind, without duplication, whether in existence at the date hereof or hereafter, imposed or levied by any federal, provincial, municipal, school or other applicable or relevant taxing authority or body, in respect of the Leased Premises or the movable property, trade fixtures and other property placed by the Tenant in, on or about the Leased Premises or in respect of the use and occupancy of the Leased Premises or the business carried on therein. If any such taxes, rates, duties, levies, assessments or other charges are imposed or levied against the Landlord or the Landlord’s property and the Landlord pays the same (which the Landlord shall have the right to do regardless of the validity of such levy), then the Tenant shall forthwith reimburse the Landlord, as Additional Rent, the amount of such

 

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payment by the Landlord. In addition, the Tenant shall pay and discharge all licence fees and other like fees that may be levied, charged, rated or assessed against the Leased Premises or any equipment located therein or the business carried on by the Tenant therein. The Tenant will indemnify and keep the Landlord indemnified from and against payment of all losses, costs, charges and expenses which may be imposed or levied against the Landlord or its property or incurred by the Landlord in respect of such taxes, rates, duties, levies, assessments, charges or licence fees and the Tenant hereby agrees to furnish to the Landlord, within thirty (30) days after the date such taxes, rates, duties, levies, assessments, charges or licence fees became due and payable, receipts or appropriate evidence of payment of the same.

 

  8.3 Utilities, Heating, Air-Conditioning and Ventilation - The Tenant shall cause the Leased Premises to be kept reasonably heated, ventilated and air-conditioned throughout the Term, in accordance with the standards described in Schedule “B-l” hereof. The Landlord has provided heating, ventilation and air-conditioning equipment in accordance with said Schedule “B-l”. The Tenant shall be solely responsible to pay, as Additional Rent, all heating, ventilating and air-conditioning costs of the Leased Premises. If the Tenant desires to operate the HVAC system 24 hours a day, it may do so at its cost. In addition, the Tenant shall be required to pay as part of Operating Costs its Proportionate Share of the costs to heat, ventilate and air-condition the Common Areas and Facilities of the Building. The Tenant shall promptly advise the Landlord of any repair or maintenance required to be made to the heating, ventilation and air-conditioning equipment servicing the Leased Premises and the Landlord shall carry out such repairs, replacement (if needed) and maintenance services, the costs of which shall form part of Operating Costs. The Landlord reserves the right to inspect from time to time on one (1) Business Day’s prior notice (except in the case of an emergency, in which case no such notice is required) such heating, ventilation and air-conditioning equipment and should such inspection reveal, in the Landlord’s opinion, that repair or maintenance is required, the Landlord shall be entitled to carry out the same without prior notice to the Tenant, the costs of which shall form part of Operating Costs. When entering the Leased Premises, if required, for maintenance, the Landlord will ensure that its personnel respect any reasonable instructions given by the Tenant regarding security measures to be taken in the Leased Premises, especially in the laboratory areas thereof. If such equipment is destroyed or damaged due to the fault or negligence of the Tenant, the cost of repairing or replacing the same shall be at the sole cost of the Tenant and shall not form part of Operating Costs.

The Landlord, at the commencement of the Term, shall provide at its expense metering devices for purposes of monitoring the use of natural gas (if applicable), electricity and, if appropriate, water to respect of the Leased Premises. The Tenant shall pay promptly, and in any event on or before their due date, to the relevant public utility authorities all charges for heat, fuel, water, gas, electricity, light, sewer charges and other utilities used by the Tenant in respect of the Leased Premises. The Tenant shall execute with the relevant public utility authorities contracts for the supply of such services to the Leased Premises and, as indicated above, shall be solely responsible for the payment of such services and utilities and shall pay the same directly to such suppliers. In the event there is no separate meter for water, the Tenant shall pay its Proportionate Share of the cost of water supplied to the Building.

The Landlord shall supply initial (but not replacement) fluorescent tubes at its costs. Costs to maintain the lighting system will form part of Operating Costs. Such costs shall be competitive. The Landlord shall not charge any administrative fees on electricity costs or gas (if any) consumed in the Leased Premises and which costs are paid directly by the Tenant to the supplier(s).

 

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  8.3A Generator - Subject to the Tenant furnishing to the Landlord architectural, mechanical and engineering plans showing in reasonable detail the work hereinafter described to be carried out and the quality and appearance of materials to be used and the estimated cost thereof, and subject to the other provisions set out herein, the Tenant shall have the right, at any time, whether it be prior to the Delivery Date or during the Term or any renewal thereof, to install in the Building, at a location to be mutually agreed between the Landlord and the Tenant acting reasonably, a generator dedicated to the Tenant’s equipment and computer in the Premises. It is understood that in the determination of the location for the installation of the generator in the Building, the Landlord will use reasonable efforts to offer a location that will assist to minimize the costs to be incurred by the Tenant to connect the generator to its UPS unities to be installed in the Leased Premises. Concurrently and subject to submitting the aforesaid plans and specifications, etc., the Tenant shall have the right to install in the Leased Premises its required UPS unities and required wires or cables, the whole at its cost and at a location selected by the Tenant’s professional and agreed to in writing by the Landlord and its professionals acting reasonably.

Save as otherwise specifically provided herein to the contrary, in carrying out such installation, usage, maintenance and all other work in connection with said generator and UPS unities, the Tenant shall comply with the provisions of Section 13 hereof. For such purposes, the work in respect of the generator and the UPS unities shall be deemed to be “Work”.

All costs related to the installation, the usage, the maintenance and repairs of the generator and its related UPS unities will be the sole responsibility and assumed by the Tenant (including, if required, the addition or modification of conduits of the Building necessary to connect the generator to its UPS unities). In addition, the Tenant shall indemnify and hold harmless the Landlord from and against any and all losses, claims, actions, damages, liabilities and expenses including, legal fees and disbursements in connection with loss of life, personal injury, damage to property or any other loss or injury of whatsoever nature or kind arising out of the installation, use, maintenance, repair or removal of all or any of the said generator and/or unities or any replacement thereof or testing thereof.

The Tenant is hereby authorized by the Landlord to use its own professional in relation to any work for the installation, usage and maintenance of the generator and related connections and the UPS unities. Accordingly, subject to prior written notice to be given to the Landlord, unless there is an emergency in which case such notice shall be given as is reasonable in the circumstances, the Tenant and its professionals shall be given access to the required areas of the Building in order to meet their obligations. The Landlord shall be entitled to supervise the Tenant’s work and shall be reimbursed for all costs and expenses incurred with respect to the supervision of such work, including professional fees and costs, plus an administration fee equal to fifteen percent (15%) of such costs.

To insure that its generator functions properly, the Tenant shall have the right to proceed with “delestage” test(s) from time to time. Prior to carrying out any such testing from time to time, the Tenant shall submit in writing to the Landlord for its prior written approval, not to be unreasonably refused, a schedule for the proposed testing as well as a detailed description of procedures and methods to be employed in carrying out such testing and the names, addresses and qualifications of each person responsible to carry out such testing, all of which must be acceptable to the Landlord acting reasonably. As indicated above, the Landlord shall not be responsible in any manner for loss or any damage suffered by any person whatsoever, whether the Tenant, or any other tenant, as a result of the malfunction or the breakage of the generator and the Tenant fully indemnifies the Landlord in respect of any such losses or damages.

 

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The Tenant shall not be required to pay Basic Minimum Rent or any share of Operating Costs for the usage of space in the Building to access the generator and possibly the usage of the risers or conduits of the Building to install and connect its generator to its Premises but the Tenant shall be responsible for all other costs in connection with the installation, usage and removal of said generator and other related equipment. If required by law, the location where the generator will be placed shall be isolated from other space at the Tenant’s costs and the Tenant shall be entitled to lock said space, provided that access to the said space is always available to the Landlord and in this regard, the Tenant shall provide the Landlord with keys, access codes or other such required information so that access is available twenty-four (24) hours a day to the Landlord.

At the end of the Term, or earlier termination thereof, the Tenant will have the right to remove its generator and UPS unities and if it chooses to so remove the same, it shall be at its cost and expense and it shall make good all damage caused to the Leased Premises and Building as a result of such installation and removal and return the Leased Premises to the Landlord in a “broom clean” condition, reasonable wear and tear excluded. In addition and notwithstanding that the Tenant may not choose itself to remove the same, the Landlord may require the Tenant to remove said generator and UPS unities and in such event, the Tenant shall remove the same at its own cost and expense and make good all damage caused as a result of their installation and removal, the whole as provided above.

 

  8.4 Operating Costs - The Tenant shall pay to the Landlord, or as the Landlord may direct, as Additional Rent in each and every Rental Year during the Term of this Lease, all Operating Costs relating to or allocated to the Leased Premises and its Proportionate Share of Operating Costs relating to or allocated to the Building, the Lands, the Property and the Common Areas and Facilities or any part thereof, in equal monthly installments in advance in accordance with the estimates prepared pursuant to Section 8.6 hereof.

The Landlord agrees that it shall in increasing Operating Costs, act as a prudent administrator taking into account that the Property is situated in a first class technology park. Furthermore, the Landlord agrees that if services are provided by a non-arms length entity to the Landlord and the costs of such services form part of Operating Costs, such services will be provided on a competitive basis.

 

  8.5 Administrative Fees - Operating Costs and Taxes shall include an administration fee payable to the Landlord equal to the greater of fifteen percent (15%) of the aggregate of Operating Costs and Taxes and sixty-five cents ($0.65) per square foot of the Rentable Area of the Leased Premises. There shall be no administration fee charged on the Tax on Capital.

 

  8.6

Landlord’s Right to Estimate Taxes, Operating Costs and Other Costs and Expenses - Notwithstanding the provisions of Section 8.1 hereof, the Landlord may estimate Taxes and as provided in Section 8.4 hereof, Operating Costs and the Tenant’s share thereof and of any other costs and expenses payable by the Tenant pursuant to this Article 8 for such periods as the Landlord may determine from time to time (provided in no case shall such periods exceed twelve (12) months) and the Tenant agrees to pay to the Landlord such amounts as so estimated in monthly installments in advance during such periods, as Additional Rent, on the first (1st) day of each calendar month of such periods. Such estimates shall in every case be a reasonable estimate and based wherever possible upon previous operating experience. From time to time, the Landlord may re-estimate, on a reasonable basis, the amount of Taxes and Operating Costs for any period, in which case the Landlord shall advise the Tenant in writing of such re-estimate and fix new equal monthly installments for the remaining balance of such period such that, after giving credit for the installments paid by the Tenant on the basis of the previous estimate, the

 

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Tenant’s share of Taxes and Operating Costs will have been paid during such period. Notwithstanding anything herein contained to the contrary, as soon as bills for all or any portion of the said Taxes, Operating Costs and expenses so estimated are received, the Landlord may bill the Tenant for the Tenant’s share thereof as determined pursuant to this Lease, and the Tenant shall pay the Landlord such amounts so billed (less all amounts previously paid by the Tenant on the basis of the Landlord’s estimate thereof), as Additional Rent, within thirty (30) days after demand. If the Landlord chooses to require payment of Taxes as soon as bills for all or any portions of the same are received, then the Tenant shall pay such Taxes to the Landlord within thirty (30) days of the receipt from the Landlord of a written statement and invoice of said Taxes. For clarification purposes, if the Landlord chooses to require the Tenant to pay Taxes within thirty (30) days of invoice thereof, and if the timing of such invoices coincides with installment dates which the Landlord is permitted for payment of Taxes to the municipality, and if the Landlord chooses to pay Taxes in more than one installment in accordance with such payment schedule of the municipality, then the Tenant shall also be entitled to pay Taxes on a similar installment basis to the Landlord. The foregoing right of the Tenant to pay in installments shall not apply to the first (1st) year or last calendar year of the Lease.

Within a reasonable period of time after the end of the period for which such estimated payments have been made and in any event, on an annual basis, the Landlord shall send to the Tenant a statement setting forth in reasonable detail the costs included in Operating Costs and Taxes for the then completed period and the Tenant’s share of the amounts and costs payable by the Tenant under the provisions of this Section 8.6. Said statements shall be certified by the Landlord’s auditors and shall take into consideration any exclusions in Operating Costs as provided in this Lease. If the amount the Tenant has paid is less than the amount due, the Tenant shall pay such additional amounts forthwith upon (and in any event, no later than thirty (30) days after) the receipt of such statement and if the Tenant has paid in excess of the amount due, the excess shall, at the Landlord’s sole discretion, either be refunded by the Landlord without interest within a reasonable period of time after delivery of the said statement (but in any event, prior to the expiration of the abovementioned thirty (30) day period), or credited to future or outstanding Additional Rent due by the Tenant to the Landlord. The preparation costs of the annual statements shall form part of Operating Costs. If the Tenant has any questions concerning any item on such statements, the Landlord shall use reasonable efforts to provide the Tenant’s auditors with an explanation thereof and to allow the Tenant’s auditors to consult, but not to make copies of the supporting documents therefor.

 

  8.7 Evidence of Payment of Additional Rent - The Tenant shall from time to time, at the request of the Landlord, deliver to the Landlord satisfactory evidence of the due payment by the Tenant of all payments required to be made by the Tenant under this Lease.

 

  8.8 Failure to Pay Additional Rent - If the Tenant fails to pay its taxes, any insurance premium, utility or service charge, its Proportionate Share or share of Operating Costs or its Proportionate Share or share of Taxes or other charges or debts which it owes and has herein covenanted to pay, as Additional Rent or otherwise, the Landlord may pay the same and the Landlord, in addition to any other rights or remedies it may have hereunder or at law, is entitled to the same remedies and may take the same steps for the recovery of all such sums as it might have and take for the recovery of Rent in arrears under the terms of this Lease. All arrears of Rent and any moneys paid by the Landlord hereunder shall bear interest at the Stipulated Rate of Interest from the time such arrears become due until paid to the Landlord.

 

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  8.9 Proportionate Share of Taxes and Operating Costs in Respect of the First and Last Rental Years of the Term - The Tenant’s Proportionate Share of Taxes and Operating Costs in respect of the first and last Rental Years of the Term of this Lease shall be adjusted between the Landlord and the Tenant on the basis of the number of days in such first and last Rental Years based upon a period of three hundred and sixty-five (365) days.

 

  8.10 Tenant’s Proportionate Share of Building Share - For purposes of calculation of the Tenant’s Proportionate Share of Operating Costs and Taxes and any other cost, expense, imposition or charge provided for herein, in respect of which the Tenant is required to pay its Proportionate Share, such calculation shall include the Tenant’s Proportionate Share of the Building Share of such Operating Costs, Taxes and other costs, expenses, impositions or charges.

 

9. SALES TAXES

 

 

9.1

Tenant’s Sales Taxes - Notwithstanding any other provisions of this Lease, the Tenant shall pay to the Landlord an amount equal to any and all taxes imposed on the Tenant and required to be remitted by the Landlord with respect to Basic Minimum Rent, Additional Rent or any other amount payable by the Tenant to the Landlord under this Lease, whether characterized as a goods and services tax, sales tax or whether known by any other name (herein in this Section 9.1 called “Tenant’s Sales Taxes”), it being the intention of the parties that the Landlord shall be fully reimbursed by the Tenant with respect to any and all Tenant’s Sales Taxes and Landlord’s Sales Taxes. The amount of Tenant’s Sales Taxes payable by the Tenant shall be calculated by the Landlord and imposed against the amounts due by the Tenant to the Landlord under the terms of this Lease and shall be paid to the Landlord at the same time as the amounts to which the Tenant’s Sales Taxes so apply are payable to the Landlord under the terms of this Lease, and the Landlord may make any estimates necessary for the purposes of such calculations in the same manner as provided in this Lease for payment of Operating Costs. Notwithstanding any other provision in this Lease to the contrary, the amounts payable by the Tenant under this Section 9.1 shall be deemed not to be Basic Minimum Rent or Additional Rent, but the Landlord shall have all of the same remedies for and rights of recovery of such amounts as it has for recovery of Rent under this Lease.

 

10. INSURANCE

 

 

10.1

Landlord’s Insurance - During the Term, the Tenant shall pay its Proportionate Share of the cost of insurance placed by the Landlord in respect of the Building, the Lands and the Property. The Landlord shall obtain and maintain in full force and effect during the Term such insurance for such occurrences and in such amounts and on such terms and conditions and with such deductibles as the Landlord may determine from time to time. Unless and until otherwise determined by the Landlord, said insurance shall include:

 

  10.1.1 insurance on the Building, the Landlord’s Work, the Tenant’s Fit-Up and equipment contained in the Building owned or leased by the Landlord or which the Landlord desires to insure in an amount not less than the full replacement cost thereof against loss or damage by fire and other risks contained in fire insurance policies with endorsements generally known as extended coverage (including, without limitation, flood and earthquake coverage) and riot, vandalism and malicious acts endorsement or, at the Landlord’s option, “all risks” insurance;

 

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  10.1.2 broad form boiler, machinery and unfired pressure vessel insurance, including repair or replacement coverage in an amount as the Landlord may from time to time determine;

 

  10.1.3 public liability insurance for bodily injury and property damage in such amount as the Landlord may from time to time determine;

 

  10.1.4 rental income insurance covering such occurrences, in such form and with such period of indemnity as the Landlord may determine;

 

  10.1.5 such other insurance in amounts and on terms as the Landlord, in its discretion, may determine or a Hypothecary Creditor may require.

The Tenant acknowledges that the cost of maintaining the above-mentioned insurance will be included in Operating Costs. The Tenant’s responsibility for the payment of the costs and expenses of the insurance policies required to be maintained by the Landlord pursuant hereto shall include, without limitation, the cost of all deductible amounts. Notwithstanding that the Tenant shall be contributing to the Landlord’s costs and premiums respecting such insurance pursuant to the terms of this Lease, the Tenant shall not have any insurable or other interest in any of the Landlord’s insurance other than the rights, if any, expressly set forth in this Lease or in any policy of insurance obtained by the Landlord, and, in any event, the Tenant shall not have any interest in or any right to recover any proceeds under any of the Landlord’s insurance policies. The proceeds of all insurance policies provided or maintained by the Landlord pursuant to this Section 10.1 shall be payable to the Landlord and to any loss payee named in any mortgage endorsement as their respective interests may appear. The Tenant shall not do and shall not cause, suffer or permit to be done or omitted to be done by any of its servants, agents, contractors or persons for whom the Tenant is in law responsible anywhere on the Property, the Lands, the Leased Premises or elsewhere in the Building or by any person in, on or about the Leased Premises, the Lands, the Property or the Building and shall not permit there to be on the Leased Premises, the Lands, the Property or the Building anything which might: (i) result in any increase in the cost of any insurance policies of the Landlord or any others on or related to the Building, the Lands, the Property or any part thereof or contents thereof; (ii) result in an actual or threatened cancellation of or adverse change in any policy of insurance of the Landlord or others on or related to the Building, the Lands, the Property or any part or contents thereof; or (iii) be prohibited by any policy of insurance of the Landlord or any others in force from time to time in respect of the Building, the Lands, the Property or any part or contents thereof. If the cost of any insurance policies of the Landlord or any others on or related to the Building, the Lands, the Property or any part or contents thereof shall be increased as a result of (i) the use or occupancy of the Leased Premises by the Tenant or any other person on the Leased Premises; or (ii) anything kept or permitted to be kept by the Tenant or by any person anywhere on the Leased Premises or by the Tenant or any of its employees, customers, contractors, suppliers or persons for whom the Tenant is in law responsible on any part of the Building, the Lands and the Property; or (iii) any act or omission of the Tenant or any person on the Leased Premises, or of the Tenant or any of its employees, customers, contractors, suppliers or persons for whom the Tenant is in law responsible on any part of the Building, the Lands and the Property, the Tenant shall pay the full amount of such increase in cost to the Landlord forthwith upon demand, whether the increase is an increase in insurance costs payable by the Landlord or by any other tenant or occupant of the Building, the Lands, the Property or any part thereof. In determining the Tenant’s responsibility for any increased cost of insurance as aforesaid, a statement issued by the organization, company or insurer establishing the insurance premiums or rates for the relevant policy shall be conclusive evidence of the various components of such premiums or rates and the factors giving rise to any increase therein.

 

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  10.2 Tenant’s Insurance - During the Term, the Tenant shall, at its sole cost and expense, take out and keep in full force and effect the following insurance:

 

  10.2.1 comprehensive general liability insurance, including, but not limited to, property damage, public liability, personal injury liability, contractual liability, non-owned automobile liability and owners’ and contractors’ protective insurance coverage, all on an occurrence basis, with respect to any use, occupancy, activities or things on the Leased Premises and with respect to the use and occupancy of any other part of the Property by the Tenant or any of its servants, agents, contractors or persons for whom the Tenant is in law responsible, with coverage for any one occurrence or claim of not less than Five Million Dollars ($5,000,000.) or such other amount as the Landlord or the Hypothecary Creditor may reasonably require upon not less than one (1) month’s notice at any time;

 

  10.2.2 insurance in respect of such perils as are from time to time covered in an “all risks” policy not less broad than the standard commercial property floater policy with the exclusions relating to earthquake and flood removed therefrom, covering Tenant’s Leasehold Improvements, trade fixtures, furnishings, equipment, stock-in-trade and inventory on or about the Leased Premises for not less than the full replacement cost thereof and with a replacement cost endorsement; if there is a dispute as to the amount which comprises full replacement cost, the decision of the Landlord or Hypothecary Creditor shall be conclusive;

 

  10.2.3 broad form comprehensive boiler and machinery insurance on the Tenant’s Leasehold Improvements and on all insurable objects located on the Leased Premises which are the property or responsibility of the Tenant (which shall not include for greater certainty property owned or leased by the Landlord) on a blanket repair or replacement basis with a replacement cost endorsement and with limits for each accident in an amount not less than the full replacement cost of all Tenant’s Leasehold Improvements, trade fixtures, furnishings, equipment, stock-in-trade in, on or about the Leased Premises;

 

  10.2.4 business interruption insurance either as an extension to or in the same form as the insurance referred to in Subsections 10.2.2 and 10.2.3 above, providing coverage for a period of no less than twelve (12) months, with a deductible of no more than seven (7) days and in such amount from time to time as is necessary to fully compensate the Tenant for direct or indirect loss of sales or earnings resulting from or attributable to any of the perils required to be insured against under the policies referred to in Subsections 10.2.2 and 10.2.3 above and all circumstances usually insured against by cautious tenants including losses resulting from interference with or prevention of access to the Leased Premises or the Property as a result of such perils or for any other reason;

 

  10.2.5 Tenant’s legal liability insurance for the full replacement cost of the Leased Premises and the loss of use thereof; and

 

  10.2.6 insurance against such risks and in such amounts as the Landlord or any Hypothecary Creditor may, from time to time, reasonably require upon not less than thirty (30) days’ written notice.

 

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Concurrently with the execution of this Lease, the Tenant shall provide the Landlord with certificates of insurance acceptable to the Landlord and if required by the Landlord in its form certifying the insurance coverage required to be placed by the Tenant pursuant hereto and thereafter with renewals thereof at least thirty (30) days prior to any expiry thereof. In addition, within a reasonable period from the date of execution hereof, the Tenant shall provide the Landlord with a certified copy of said insurance policies and thereafter with certified copies of renewals or amendments thereto. In addition, if required by a Hypothecary Creditor, the Tenant shall furnish to the Landlord, within fifteen (15) days after demand therefor by the Landlord, additional certificates of insurance of the same. Furthermore, the Tenant specifically acknowledges that if the Landlord requires a certificate or other document from the Tenant from time to time certifying that the Tenant has complied with the insurance requirements of this Lease, the Tenant will provide such certificate within ten (10) days of being asked therefor. In the event the Tenant fails to obtain any insurance referred to in this Section 10.2, the Landlord may, without prior written notice or demand to the Tenant and without prejudice to any rights or remedies it may have, place such insurance with insurance companies and through brokers of its choice and the cost thereof together with interest on such payment at a rate equal to the Stipulated Rate of Interest from the date such payments are made by the Landlord until reimbursed by the Tenant shall forthwith be payable by the Tenant to the Landlord. The Tenant hereby agrees and acknowledges that the placing of any of the above-mentioned insurance shall in no way relieve the Tenant from any obligation assumed under this Lease.

The insurance policies required to be maintained by the Tenant pursuant to this Section 10.2 shall name the Landlord and any persons, firms or corporations designated in writing by the Landlord as named insureds as their interests may appear with loss payable to the Landlord and such additional named insureds under the policies referred to in Subsections 10.2.2 and 10.2.3 and, where applicable, referred to in Subsection 10.2.6. In the event the Tenant is obliged to repair the Tenant’s Leasehold Improvements pursuant to the provisions of this Lease after any damage or destruction and provided that the Tenant is not otherwise in default under the terms of this Lease, the Landlord covenants, on its behalf but not on the behalf of any additional named insured, to cause any proceeds payable to it pursuant to the insurance policies referred to in Subsections 10.2.2 and 10.2.3 to be made available for the purposes of repairing such Tenant’s Leasehold Improvements or replacing any damaged fixtures, furnishings or other property of the Tenant in respect of which such insurance proceeds are payable. All insurance policies shall be in form and substance satisfactory to the Landlord, shall provide for a waiver by the insurer of its rights under Article 2494 of the Civil Code of Quebec, shall contain the standard mortgage clause as reasonably required by any Hypothecary Creditor and shall be considered as primary insurance and shall not call into contribution any insurance of the Landlord. The insurance required to be maintained by the Tenant shall contain a waiver of subrogation in favour of the Landlord, its agents and employees and in favour of those for whom the Landlord is in law responsible and the general liability policy shall in addition contain a provision for cross-liability and severability of interest. All policies shall contain an endorsement requiring the insurers under such policies to notify the Landlord and any Hypothecary Creditor in writing at least thirty (30) days prior to any material change or cancellation thereof and shall contain a waiver in favour of the Landlord and any Hypothecary Creditor of any breach of warranty clause such that the insurance policies in question shall not be invalidated with respect to their interests by reason of any breach or violation of any warranties, representations, declarations or conditions contained in the policies; all policies shall be taken out with insurers acceptable to the Landlord and shall be in a form satisfactory from time to time to the Landlord. The Tenant covenants that nothing will be done or omitted to be done whereby any insurance policy referred to in Section 10.1 or this Section 10.2 will be cancelled and not immediately replaced or whereby the Leased Premises shall be rendered uninsurable or whereby the insurance proceeds under any such insurance policy which would be payable to the Landlord might be assigned to or hypothecated in favour of others.

 

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11. COMMON AREAS AND FACILITIES AND RULES AND REGULATIONS

 

  11.1 Landlord’s Control of the Common Areas and Facilities - All Common Areas and Facilities shall at all times be subject to the exclusive control and management of the Landlord. The Landlord, acting reasonably and subject to the Landlord’s obligation to provide peaceful enjoyment as provided in Section 28 hereof, shall be entitled to construct, alter, maintain, eliminate, operate and police the same; to change the area, location and arrangement thereof; to employ personnel and to make rules and regulations pertaining to and necessary for the proper operation and maintenance thereof; and to do and perform such other acts therein and with respect thereto as the Landlord determines advisable.

 

  11.2 Tenant’s Use of Common Areas and Facilities - Subject to the Rules and Regulations promulgated by the Landlord from time to time, the Landlord covenants to allow the Tenant, in common with other tenants of the Building and the Property and others entitled to use them, the use of the common outside parking areas, driveways, walkways and grounds forming part of the Common Areas and Facilities, as may be designated by the Landlord from time to time, during regular business hours of the Tenant on Business Days. It is agreed that the Tenant and all other persons hereby permitted to use such Common Areas and Facilities shall do so at their sole risk and under no circumstance shall the Landlord be liable for any damage or injury resulting to any persons or property while using such Common Areas and Facilities.

 

  11.3 Maintenance of Common Areas and Facilities - The Landlord shall see that (subject to Unavoidable Delay) the Common Areas and Facilities of the Building and the Property are kept in good and substantial state of repair, including the keeping of the driveways, walkways and parking lot, curbs, lawns and grounds in and about the Building and the Property in good condition. Notwithstanding the foregoing the Tenant specifically acknowledges that the Landlord’s obligation in respect of snow and ice removal shall be limited to retaining a contractor to provide for snow and ice removal.

 

  11.4 Elevators - Any elevator servicing the Building shall be maintained and repaired by the Landlord and the cost thereof shall form part of Operating Costs. The Landlord shall not be liable for any loss, cost or damage caused to the Tenant, its employees, agents, servants, visitors, licensees or any other person as a result of the use of such elevator or resulting from any breakdown or disrepair or inability to use the same for whatsoever reason, nor shall there be, consequent upon the foregoing, any abatement or reduction in Rent. Any permit required for the operation of such elevator shall be obtained by the Landlord and the cost of the same shall form part of Operating Costs.

 

  11.5 Rules and Regulations - The Tenant covenants to comply with the Rules and Regulations, a copy of which is annexed hereto as Schedule “D”, and to cause such Rules and Regulations to be observed and performed by everyone for whom the Tenant is in law responsible or over whom the Tenant might reasonably be expected to have control. The Landlord shall have the right, from time to time and at any time during the Term, to make any and all reasonable amendments, deletions and additions to such Rules and Regulations including rules and regulations relating to the use of the Common Areas and Facilities. Such Rules and Regulations, together with all reasonable amendments, deletions and additions made thereto by the Landlord and notice of which shall have been given to the Tenant, shall be read as part of this Lease and shall be observed, performed and complied with throughout the Term in the same manner as all of the other conditions, provisions, agreements and obligations herein contained and set forth.

 

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  11.6 Control of the Building, Lands and Property - The Building, Lands and Property, shall at all times be subject to the exclusive control and management of the Landlord. Notwithstanding any provision of this Lease or any Schedule annexed hereto to the contrary, the Landlord reserves the right at any time and from time to time to change, alter, modify, reduce or expand, the Common Areas and Facilities, the Building, the Property or any portion thereof, as the Landlord, in its sole and entire discretion, deems expedient, the same to include, without limitation, the right of the Landlord to:

 

  11.6.1 change the area, level, location, arrangement or use of the Property or any part thereof;

 

  11.6.2 construct other buildings, structures or improvements on the Property and make alterations and additions thereto, subtraction therefrom or rearrangement thereof;

 

  11.6.3 expand the width or length of the Building and construct additional buildings or facilities adjoining or approximate to the Building;

 

  11.6.4 change, alter and amend the location, dimensions or specifications of the pipes, wires, ducts, conduits, utilities, mechanical systems, common areas and other building services (including such as may be contained in the Leased Premises);

 

  11.6.5 [intentionally deleted];

 

  11.6.6 close all or any portion of the Property to the extent required in the opinion of the Landlord’s counsel to prevent any person from acquiring rights therein;

 

  11.6.7 grant, modify or terminate servitudes and other agreements pertaining to the use and maintenance of all or any part of the Property;

 

  11.6.8 obstruct or close off all or any part of the Property, for the purposes of maintenance, repair, alteration or construction;

 

  11.6.9 use any part of the Property for displays or decorations for special activities;

 

  11.6.10 provide supervision, policing or security services for the Property;

 

  11.6.11 control, supervise and regulate the delivering and shipping of goods, merchandise, supplies and fixtures to and from the general shipping and receiving areas in the Building;

 

  11.6.12 designate and specify the kind of container to be used for garbage and refuge as well as the manner and the times and places at which such is to be placed for collection;

 

  11.6.13 designate a commercial service for the pick-up and disposal of garbage and refuse instead of or in addition to the service provided by the City of Saint-Laurent, at Tenant’s cost;

 

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  11.6.14 eliminate, substitute or rearrange any or all of the Common Areas and Facilities; and

 

  11.6.15 do and perform such other acts in and to the Property, as the Landlord determines to be advisable for the more efficient and proper operation of the Property.

Notwithstanding the foregoing, the Landlord hereby agrees to use its best efforts so that no changes, alterations, modifications, reductions or expansions will be made to the Property which would materially affect the access to the Property, the visibility of the Leased Premises or the ability of the Tenant to use the Leased Premises in accordance with the provisions of this Lease. Subject to the foregoing, no action on the part of the Landlord in exercising any of its aforesaid rights, shall constitute an eviction hereunder or change in the form or destination of the Leased Premises or any diminution of the peaceful enjoyment of the Tenant nor shall the Tenant be entitled to any compensation or diminution or abatement of Basic Minimum Rent or Additional Rent, the Tenant hereby waiving and renouncing to any and all claims as a consequence of the foregoing including without limitation the benefit of its rights and recourses resulting from Article 1856 of the Civil Code of Quebec. If pursuant to the exercise by the Landlord of its rights described herein, additional land is used for serving the Building, such additional land shall be presumed to be included in the definition of “Lands” contained herein. Furthermore, if following the exercise by the Landlord of any of its rights described above, the Rentable Area of the Building is increased or decreased, the Tenant’s Proportionate Share shall be modified accordingly.

 

12. REPAIRS AND MAINTENANCE

 

  12.1 Tenant’s Repairs - Notwithstanding the provisions of Articles 1854 and 1864 of the Civil Code of Quebec, but except as may be otherwise provided in Sections 1.1.17 and 12.2, the Tenant shall, at its sole cost and expense, operate, maintain and keep or cause to be kept the Leased Premises and every part thereof in good repair, good order and good condition as they would be kept by a careful owner and to use the same as a prudent administrator and shall, subject to the provisions of Sections 8.3, 14.1 and 14.2 hereof, promptly make all needed repairs and replacements to the Leased Premises including, without limitation, those necessary in order to keep and maintain the Leased Premises in a state of good repair, good order and good condition. At the expiration of the Term, the Tenant shall surrender the Leased Premises in the aforesaid condition, reasonable wear and tear only excepted.

 

  12.2 Landlord’s Repairs - Notwithstanding the provisions of Section 12.1 hereof the Landlord shall throughout the Term, subject to the provisions of Article 14 hereof and Unavoidable Delay, be responsible to effect all structural repairs and the Landlord shall be responsible for the same, unless any such repairs are the consequence of the negligent acts or omissions of the Tenant or those for whom the Tenant is at law responsible in which case the cost of such repairs (together with an administration fee of fifteen percent (15%) of such costs) shall be paid by the Tenant forthwith upon demand as Additional Rent. The word “structural” shall only include the foundations, footings, structural columns and beams, structural sub-floors, bearing walls and other parts of the structure. For greater certainty, repairs to exterior walls, windows or the roof of the Building are not considered structural.

The Landlord shall carry out the maintenance and repair of exterior walls, windows and roof of the Building and, as provided in Section 8.3 hereof, carry out the maintenance and repair of the heating, ventilating and air-conditioning system servicing the Leased Premises and shall see that the Building (other than the Leased Premises and premises of other tenants) is in a good state of repair. All costs incurred by the Landlord in respect of the foregoing maintenance and repair of

 

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the Building shall form part of Operating Costs save if the same are stated hereunder to be at the sole cost and expense of the Tenant. If any equipment or system is destroyed or damaged due to the fault or negligence of the Tenant, the cost of repairing or replacing the same, shall be at the sole cost of the Tenant and shall not form part of Operating Costs.

The maintenance, repair and replacement of any and all equipment located in the Leased Premises which is the property of the Tenant, including that located in the laboratory portion of the Leased Premises, shall remain the sole responsibility of the Tenant, the whole at its sole cost and expense (and shall not form part of Operating Costs). The Tenant shall be allowed to retain the services of its own entrepreneur to effect services to equipment, which is the property of the Tenant but not to that, which is the property of the Landlord. The maintenance, repair and replacement of any equipment located in the laboratory portion of the Leased Premises which is the property of the Landlord, shall be the sole responsibility of the Landlord and shall be carried out in accordance with the relevant manufacturer’s specifications (if any) and otherwise in accordance with industry standards and the cost thereof shall form part of Operating Costs, unless such equipment is solely for the benefit of the Tenant, in which case, the Tenant shall be solely responsible for the cost thereof. If such equipment is destroyed or damaged due to the fault or negligence of the Tenant, the cost of repairing or replacing the same shall be at the sole cost of the Tenant and shall not form part of Operating Costs.

 

 

12.3

Cleaning of Leased Premises - The Landlord shall provide daily cleaning service to the Leased Premises including all bathrooms located within the Leased Premises ( in accordance with the Manual Procedure for cleaning, as detailed in Schedule “J” attached hereto, as well as periodic window cleaning service, such expenses to be included in Operating Costs of the Leased Premises. Cleaning costs of the Common Areas and Facilities of the Building shall also be provided by the Landlord and shall form part of Operating Costs for the Building.

If the Tenant requires special cleaning and maintenance services for the laboratory portion of the Leased Premises over and beyond those provided in the Manual Procedure for cleaning then the Tenant acknowledges and agrees that the following provisions will apply. Such special cleaning and maintenance services shall be provided at the sole cost and expense of the Tenant, by the Landlord through designated contractors which have recognized expertise in providing such specialized services and the Landlord shall also be entitled to a fifteen percent (15%) administration fee of the cost of providing such services. Any such designated contractors chosen by the Landlord will be at competitive rates.

 

  12.4 Security Service - As part of the Landlord’s Work, the Landlord shall provide a security service for the Building. In addition, the Tenant will have the right, subject to the prior approval of the Landlord, to install at its cost an additional security system as it may require, provided that such system is compatible with that has been installed by the Landlord and is hooked-up to the Landlord’s system. It is understood that any such additional security system must not in any manner limit the access of the Landlord to the Leased Premises and that the Landlord shall be provided with all security codes, etc. such that it shall at all times have full access to the entire Leased Premises.

The Tenant hereby advises the Landlord that in the Leased Premises there will be one (1) office where the Tenant intends to keep confidential materials. Accordingly, the Tenant shall be allowed to install a separate security system to access said room. It is understood that any such additional security system must not in any manner limit the access of the Landlord to the Leased Premises and that the Landlord shall be provided with all security codes, etc. such that it shall at all times have full access to the entire Leased Premises. The Landlord agrees that its personnel shall not be authorized to access said room unless there is an emergency or such access is

 

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required for the maintenance or repair of the Building. The Landlord shall provide to the Tenant a list of persons specifically designated by the Landlord who shall be allowed to access such room for such purposes. Except in the case of an emergency, said person(s) shall be accompanied by one of the Tenant’s authorized representatives at all times to enter the office and the Tenant hereby agrees to make readily available at all times its authorized representatives for such purposes. The Tenant shall supply to the Landlord, prior to taking occupancy of the Leased Premises, the names and coordinates of its authorized representatives. Notwithstanding the foregoing, the Tenant specifically acknowledges that the Landlord shall have no responsibility whatsoever for the maintenance of the confidentiality of any material kept in such room.

If the Landlord deems it appropriate, it shall provide a security service for the Property and the costs of providing such security service shall form part of the Operating Costs.

 

  12.5 Additional Services - The Landlord may, at its sole discretion, provide at competitive rates any special or additional services to the Leased Premises required by the Tenant, in which case, the Tenant shall be obliged to use the services of the Landlord or its designated contractor for any such service requested by the Tenant and the Tenant agrees to pay to the Landlord, the costs of such additional services, which shall include an administration fee equal to fifteen percent (15%) of such cost, within five (5) days of receipt of an account to this effect. These additional services include, without limitation, replacement of ceiling tiles, carpet cleaning, cleaning of window coverings, locksmith services, refuse removal and special security arrangements. In the event that the Landlord elects not to provide any such additional services, only persons having received prior written approval from the Landlord to provide such services and such persons shall be subject to the roles and regulations established by the Landlord.

 

  12.6 Services Not Supplied - In no event shall the Landlord be responsible nor liable in any way for any loss, costs, damages or expenses, whether direct or indirect or consequential, as a result of any interruption in the furnishing of any service or additional service whatsoever, nor shall there be any compensation, diminution or abatement of Rent as a result thereof. The Landlord reserves the right to stop the use or supply of any services when made necessary by reason of accident or malfunction or compliance with any laws or by-laws or orders or during any repairs, improvements or alterations thereto, which the Landlord shall deem necessary or desirable.

 

  12.7 Landlord’s Access to the Leased Premises - The Landlord and its agents shall have the right, at all reasonable times during the Term and upon reasonable notice to the Tenant, to enter the Leased Premises in order to examine the condition and repair thereof and to ascertain whether the Tenant is adequately fulfilling its obligations under the terms hereof. If as a result of such examination the Landlord deems it necessary that repairs be made to the Leased Premises, the Landlord shall (save as otherwise provided in Section 8.3 and 12.2 hereof) give written notice thereof to the Tenant in accordance with Subsection 16.1.8 hereof and thereupon the Tenant shall, within thirty (30) days from the date of delivery of the notice, commence and thereafter diligently complete the necessary repairs in a good and workmanlike manner. If the Tenant fails to make any such repair in the manner as aforesaid after having received such written notice from the Landlord requesting the Tenant to do so, the Landlord may, without prejudice to any other rights or remedies it may have, make such repairs and charge the cost thereof to the Tenant (together with an administration fee of fifteen percent (15%) of such costs and interest thereon at the Stipulated Rate of Interest until paid in full by the Tenant to the Landlord). The Landlord shall have the right at any time to make, without prior notice to the Tenant, emergency repairs and to charge the cost thereof to the Tenant. Any costs chargeable to the Tenant hereunder shall be payable forthwith on demand as Additional Rent.

 

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  12.8 Notice of Damage or Required Repairs to the Leased Premises - The Tenant shall forthwith give written notice to the Landlord of any material damage or deterioration to the Leased Premises by any cause. In addition, the Tenant shall forthwith give written notice to the Landlord of any repairs to the Leased Premises which are required to be made by the Landlord pursuant to the provisions of Section 12.2 hereof.

 

  12.9 Ownership of Leasehold Improvements - Subject to Section 12.11 hereof, all additions, alterations, modifications, improvements, Landlord’s Work, Tenant’s Fit-Up and Tenant’s Leasehold Improvements, whether Work (as defined in Article 13 hereof) or not become, upon their installation, the property of the Landlord absolutely without compensation therefor, to the Tenant or to any other person and form part of the Leased Premises and are subject to all of the provisions of this Lease and shall, at the expiration or sooner termination of the Term, be surrendered in good repair and condition and the Tenant or any other person shall not have any right to claim compensation therefore of whatsoever nature or kind.

 

  12.10 Surrender of the Leased Premises - The Tenant will, at the expiration or earlier termination of the Term, deliver vacant possession of the Leased Premises to the Landlord and shall peacefully surrender and yield up unto the Landlord the Leased Premises, with its appurtenances together with all leasehold improvements (including Landlord’s Work, Tenant’s Fit-Up and Tenant’s Leasehold Improvements), additions, alterations, changes or erections which at anytime during the Term shall be made therein or thereon, in good repair and condition, save and except for reasonable wear and tear and repairs for which the Landlord is responsible under Section 12.2 hereof, the whole without any compensation whatsoever being allowed to the Tenant or any other person.

 

  12.11 Removal of Tenant’s Machinery, Equipment and Furnishings and Improvements - The Tenant may during the Term in its normal course of business remove its machinery, equipment and furnishings, provided such machinery, equipment and furnishings have become unnecessary for the Tenant’s purposes, or the Tenant is substituting new and similar machinery, equipment and furnishings therefor, and provided in each case, the Tenant is not in default under this Lease and such removal would not result in any violation of the provisions hereof. For greater certainty, the Tenant’s machinery, equipment and furnishings shall not include any of the following: heating, ventilating or air-conditioning systems, facilities and equipment in or serving the Leased Premises, any piece of equipment required by the Tenant to be installed in the Leased Premises as part of the leasehold improvements, floor coverings, light fixtures and doors, all of which shall be deemed to be leasehold improvements and the property of the Landlord. The Tenant shall, at the expiration or earlier termination of the Term hereof, return the Leased Premises in a “broom clean” condition, reasonable wear and tear excluded, and remove its machinery, equipment and furnishings and at the request of the Landlord, all alterations or improvements made by the Tenant or the Landlord on the Tenant’s behalf, but excluding any of the Landlord’s Work and Tenant’s Fit-Up which the Tenant shall not have the obligation to remove, and shall repair any damage caused by such installation or removal, reasonable wear and tear excluded. However, when requesting the Landlord’s approval for any additional work in the Leased Premises during the Term, as per Section 13 hereof, the Landlord will indicate to the Tenant if the Landlord will require the removal of the improvements the Tenant is seeking approval for, at the end of the Term or earlier termination thereof. In addition, at the expiration or early termination of the Term hereof, the Tenant shall comply with the provisions of Section 8.3A hereof in respect of the removal of the generator and UPS unities. Any machinery, equipment, furnishings, alterations or improvements or other property left by the Tenant on the Leased Premises at the termination or expiration of the Lease shall become, at the Landlord’s option, the property of the Landlord absolutely without compensation whatsoever being allowed to the Tenant or any other person for the same and may be removed from the Leased Premises

 

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and sold or disposed of by the Landlord in such manner as it deems advisable. The Tenant’s obligations hereunder shall survive the expiration of the Term or earlier termination of the Lease.

 

13. ALTERATIONS, MODIFICATIONS OR IMPROVEMENTS

 

  13.1 Alterations, Modifications or Improvements by Tenant - After completion of the initial build-out the Tenant shall have the right to make alterations (which alterations shall include repairs for the purposes of this Article 13), modifications or improvements in or to the Leased Premises (such alterations, modifications or improvements being hereinafter in this Article 13 referred to as the “Work”), throughout the Term, at its sole cost and expense, provided the same are carried out in compliance with the requirements of all applicable statutes, laws, ordinances, regulations and orders and provided such Work shall not be commenced except with the prior written consent of the Landlord, not to be unreasonably withheld or delayed, and provided further such Work is made in compliance with the following terms and conditions:

 

  13.1.1 the Tenant shall, at its cost, prepare and furnish to the Landlord a complete set of technical drawings and plans and specifications with respect to the Work (including, without limitation, architectural, mechanical and engineering (including sprinkler plans) showing in reasonably complete detail the Work proposed to be carried out, the quality and appearance of materials to be used and the estimated cost thereof. The Landlord shall approve or reject such plans and specifications within thirty (30) Business Days after receipt of the same. If such plans and specifications are approved, all Work shall be carried out in compliance with the same. If the Tenant requires changes to such plans after they have been approved by the Landlord, any such changes must be submitted to the Landlord and approved by it in writing. The Landlord shall have the right to recover its costs (including, without limitation, professional costs) in reviewing the Tenant’s proposal for alterations, including all plans and specifications submitted in respect thereof, as well as a fifteen percent (15%) administration fee of such costs and the Tenant hereby agrees to pay such costs and fees within thirty (30) days of submission of invoices therefor;

 

  13.1.2 the value of the Leased Premises shall not, as a result of any Work proposed to be carried out by the Tenant, be less than the value of the Leased Premises before the commencement of such Work;

 

  13.1.3 all Work shall be carried out with reasonable dispatch and in a good and workmanlike manner and in compliance with all applicable permits, authorizations, building and zoning by-laws and all regulations and requirements of all competent authorities having jurisdiction over the Leased Premises;

 

  13.1.4 the Landlord shall have the right, in conjunction with others, to tender a bid to carry out the Work if tenders are being asked for by the Tenant;

 

  13.1.5 the Landlord shall have the right to supervise such Work and shall be reimbursed for all costs and expenses incurred with respect to the supervision of such Work, including professional fees and costs plus an administration fee equal to fifteen percent (15%) of such costs. The Landlord shall also have the right to be reimbursed for all other costs and expenses incurred with respect to the Work, including without limitation, the costs to update any plans relating to the Leased Premises, plus an administration fee equal to fifteen percent (15%) of such costs. The Tenant agrees to pay all such costs, fees and expenses within thirty (30) days of submission of invoices therefor;

 

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  13.1.6 when Work is executed other than by the Landlord, the Tenant shall, or shall cause its general contractor to maintain workmen’s compensation insurance covering all persons employed in connection with the Work and shall produce evidence to the Landlord of such insurance, and shall also maintain adequate property damage and public liability insurance for the protection of the Landlord and the Tenant, as the Landlord may reasonably require;

 

  13.1.7 the Tenant shall promptly pay all its contractors, professionals, suppliers and workmen and shall require that, prior to entering the Leased Premises or performing work therein, the Tenant’s contractors, subcontractors and professionals place in the hands of the Landlord, in a form satisfactory to the Landlord, a renunciation or, at the Landlord’s option, cession of priority with respect to any legal hypothec that may then or thereafter exist for work or labour performed or materials furnished. If the Tenant is unable to obtain such renunciation or cession of priority, as the case may be, after having used reasonable efforts to do so, it shall place with the Landlord security in an amount considered sufficient and satisfactory to the Landlord in order to guarantee completion of the Work and payment of the cost thereof; and

 

  13.1.8 all Work shall be at the sole cost and expense of the Tenant and when Work is executed other than by the Landlord, the Landlord may require the Tenant to furnish security reasonably satisfactory to it guaranteeing the completion of the Work and the payment of the entire cost thereof.

 

  13.2 Restrictions on Alterations, Modifications or Improvements by Tenant - Notwithstanding the provisions of Section 13.1 hereof, in no event shall the Tenant be allowed without the prior written approval of the Landlord (which approval may be withheld) to make alterations, modifications or improvements to the Leased Premises or to install any equipment which: (i) involve new or additional structures to the Building; (ii) could affect or alter in any manner the exterior appearance of the Building; (iii) could affect the mechanical, electrical, HVAC, sprinkler, plumbing systems or any other structural systems of the Leased Premises or the Building or could affect the status of any warranties on such systems or improvements; (iv) could in any manner be considered structural in nature or otherwise affect the structure of the Building or any part of the Property; (v) could affect the roof of the Building; (vi) are installed outside of the Leased Premises; or (vii) are not in conformity and harmony with the master plan of the City of Saint-Laurent for the Technoparc Saint-Laurent, and the design criteria established for the Technoparc Saint-Laurent, the whole as determined by the Landlord and its professionals, acting reasonably. In the event any alterations, modifications or improvements to be made by the Tenant would affect any of the foregoing and the prior written approval of the Landlord is given thereto, the Tenant shall be obliged to use the Landlord’s designated contractors, subcontractors and engineers to carry out the same and the Landlord shall endeavor to obtain quotes for such work prior to designating said contractors, subcontractors or engineers.

 

  13.3 Relationship between Tenant and Landlord - Notwithstanding any provisions of this Lease including, without limitation, the provisions of this Article 13, nothing in this Lease shall be construed as constituting the Tenant, the mandatary or the contractor of the Landlord in respect of the carrying out of alterations, modifications, installations, additions or improvements to the Leased Premises or as creating the relationship of principal and agent or of partnership or as creating any other relationship between the Landlord and the Tenant other than that of landlord and tenant.

 

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14. DESTRUCTION OF THE LEASED PREMISES

 

  14.1 Damage or Destruction of the Leased Premises - If the Building or a portion of the Building shall be destroyed or damaged by fire or other casualty insured against by the Landlord, then in every such event the following provisions shall apply:

 

  14.1.1 if the damage or destruction is such that the Leased Premises are rendered wholly or partially unfit for occupancy or if it is impossible or unsafe to use and occupy them and if, in either event, the damage, in the opinion of the Landlord, written notice of which is to be given to the Tenant within thirty (30) Business Days of the happening of such damage or destruction, cannot be repaired with reasonable speed and diligence within three hundred and sixty-five (365) days from the happening of such damage or destruction, then either the Landlord or, subject to the provisions of Section 14.4 hereof, the Tenant may, within five (5) Business Days next succeeding the giving of notice of the Landlord’s opinion as aforesaid, terminate this Lease by giving to the other notice in writing of such termination in which event this Lease and the Term hereby granted shall cease and be at an end as of the first day following the date of such destruction or damage and the Rent and all other payments for which the Tenant is liable under the terms of this Lease shall be apportioned and paid in full to the first day following the date of such damage or destruction or the Landlord may exercise its option as provided in Section 14.4 hereof to relocate the Tenant subject to the terms set out in Section 14.4; in the event that neither the Landlord or the Tenant so terminates this Lease or the Landlord does not exercise its option as provided in Section 14.4 hereof, then after having received the proceeds of the applicable insurance policies affecting the damaged or destroyed property, the Landlord shall repair the Leased Premises (excluding the Tenant’s Leasehold Improvements) with reasonable speed and diligence and subject to Section 14.3 hereof, the Rent hereby reserved shall abate from the happening of the damage or destruction until the damage or destruction to the Leased Premises shall be made good to the extent of enabling the Tenant to use and occupy the Leased Premises;

 

  14.1.2

if the damage or destruction is such that the Leased Premises are rendered wholly unfit for occupancy or if it is impossible or unsafe to use and occupy them and if, in either event, the damage, in the opinion of the Landlord, written notice of which is to be given to the Tenant within thirty (30) Business Days of the happening of such damage or destruction, can be repaired with reasonable speed and diligence within three hundred and sixty-five (365) days of the happening of such damage or destruction, then after having received the proceeds of the applicable insurance policies affecting the damaged or destroyed property, the Landlord shall repair the Leased Premises (excluding the Tenant’s Leasehold Improvements) with reasonable speed and diligence. Notwithstanding the foregoing, there shall be no obligation on the part of the Landlord to repair if there is less than two (2) years remaining in the Term at the time of such damage or destruction, to such event, the Landlord shall be entitled to, at its option, terminate this Lease, exercise its option as provided in Section 14.4 hereof or repair the damage and destruction in the manner as provided in this Subsection 14.1.2. In the event that the Landlord decides to terminate this Lease or exercise its option as provided in Section 14.4 hereof, it shall give written notice to the Tenant within five (5) Business Days next succeeding the giving of notice of the Landlord’s opinion as aforesaid. If the Landlord decides to terminate this Lease, then this Lease and the Term hereby granted shall cease and be at an end as of the first day

 

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following the date of such destruction or damage and the Rent and all other payments for which the Tenant is liable under the terms of this Lease shall be apportioned and paid in full to the first day following the date of such damage or destruction. In the event that the Landlord does not so terminate this Lease or exercise its option as provided in Section 14.4 hereof, then subject to Section 14.3 hereof, the Rent hereby reserved shall abate from the happening of the damage or destruction until the damage or destruction to the Leased Premises shall be made good to the extent of enabling the Tenant to use and occupy the Leased Premises;

 

  14.1.3 if, in the opinion of the Landlord, the damage or destruction can be made good as aforesaid within three hundred and sixty-five (365) days of the happening of such damage or destruction and the damage is such that the Leased Premises are capable of being partially used for the purposes for which they are leased, then after having received the proceeds of the applicable insurance policies affecting the damaged or destroyed property, the Landlord shall repair such damage or destruction to the balance of the Leased Premises (excluding the Tenant’s Leasehold Improvements) with reasonable speed and diligence and, subject to Section 14.3 hereof, the Rent hereby reserved shall abate in the proportion that the part of the Leased Premises which is rendered unfit for use or occupancy bears to the whole of the Leased Premises until the damage or destruction to the Leased Premises shall be made good to the extent of enabling the Tenant to use and occupy the Leased Premises;

 

  14.1.4 in the event the Building is destroyed or damaged so as to affect fifty percent (50%) or more of the Rentable Area of the Building or, in the opinion of the Landlord, the Building is rendered unsafe or unfit for occupancy as a result of such damage or destruction, whether or not the Leased Premises are affected, and, in the opinion of the Landlord (which shall be given by written notice to Tenant within thirty (30) Business Days of the happening of such damage or destruction), such damage or destruction can or cannot be repaired with reasonable speed and diligence within three hundred sixty-five (365) days of the happening of such destruction or damage, the Landlord may, within five (5) Business Days next succeeding the giving of notice of the Landlord’s opinion as aforesaid, either terminate this Lease or exercise its option as provided in Section 14.4 hereof. If the Landlord terminates this Lease then this Lease and the Term hereby granted shall cease and be at an end as of the first day following the date of such destruction or damage and the Rent and all other payments for which the Tenant is liable under the terms of this Lease shall be apportioned and paid in full to the first day following the date of such destruction or damage.

 

  14.2

Limitation of Landlord’s Obligations - Notwithstanding the provisions of Section 14.1 hereof and the obligations of the Landlord to repair as provided for therein, should any Hypothecary Creditor, which may have an interest in any insurance proceeds payable as a result of any damage or destruction to the Building or the Leased Premises, refuse to permit the use of such proceeds for the repair, replacement, rebuilding or restoration as hereinabove provided for or for the payment of the amounts expended for any such purposes, or should the damage or destruction be caused by a peril for which the Landlord is not insured, and provided that written notice of any such refusal or lack of insurance be given by the Landlord to the Tenant within thirty (30) Business Days of the happening of any such damage or destruction, then the obligations of the Landlord to repair or to rebuild as provided for hereinabove shall cease and be of no further force and effect and this Lease shall be terminated with effect as of the first day following the date of the damage or destruction, unless the Landlord, at the Landlord’s sole option, concurrently with the giving of such notice of the Hypothecary Creditor’s decision or of such lack of insurance, advises the Tenant that, notwithstanding the Hypothecary Creditor’s

 

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decision or Landlord’s lack of insurance, it chooses to repair and rebuild, in which event the provisions of Section 14.1 shall apply, mutatis mutandis, or unless the Landlord advises the Tenant within the same time period that it is exercising its option as provided in Section 14.4 hereof. In the event of any termination of this Lease as aforesaid, the Rent and all other payments for which the Tenant is liable hereunder shall be apportioned and paid in full to the date of such destruction or damage.

 

  14.3 Repair of Tenant’s Leasehold Improvements and Property - Nothing contained herein shall oblige the Landlord to repair, replace or reconstruct any alterations, additions, installations, modifications, the Tenant’s Leasehold Improvements, or any other improvements (except for Landlord’s Work and then only in the circumstances described in Sections 14.1 or 14.2 hereof) or any property of the Tenant. In the event the Landlord is obliged to repair the Leased Premises as provided herein and so repairs the same, the Tenant shall be obliged to repair, replace or reconstruct, in an expeditious and diligent manner, its alterations, additions, installations and improvements, the Tenant’s Leasehold Improvements and property which were located in the Leased Premises prior to such damage and destruction so as to enable the Tenant to use and occupy the Leased Premises and in any event, shall complete the same within thirty (30) days from the date that the Landlord has completed the Landlord’s Work and the Tenant’s Fit-Up in the Leased Premises. Notwithstanding the provisions of this Article 14, if the Tenant has not completed its repairs, replacements or reconstruction within the aforesaid thirty (30) days, full Rent shall be payable and there will be no further abatement or apportionment of the same regardless of the ability of the Tenant to use or occupy the Leased Premises.

 

  14.4 Replacement Premises - In the event that the Landlord has given notice as contemplated in any of Subsections 14.1.1, 14.1.2, 14.1.4 or Section 14.2 that it is exercising its option to relocate the Tenant as provided in this Section 14.4, then the Landlord shall relocate the Tenant, within ninety (90) days of the giving of such notice that it is so exercising this option, to replacement premises in any building owned by the Landlord and situated in the Technoparc Saint-Laurent (the “Replacement Premises”) provided that such relocation shall be subject to and upon the following terms and conditions:

 

  14.4.1 the Replacement Premises shall contain approximately the same area as the Leased Premises;

 

  14.4.2 the Landlord shall provide, at its expense, leasehold improvements in the Replacement Premises substantially equal and of the same quality to the standards of the Landlord’s Work and the Tenant’s Fit-Up in the Leased Premises and other work built by the Tenant and approved by the Landlord in accordance with Section 13 hereof immediately prior to such damage or destruction;

 

  14.4.3 the Landlord shall pay for the moving costs of the Tenant’s trade fixtures, equipment and furnishings from the Leased Premises to the Replacement Premises;

 

  14.4.4 Basic Minimum Rent and Tenant’s Proportionate Share of Operating Costs for the Replacement Premises shall be no greater than the Basic Minimum Rent and Tenant’s Proportionate Share of Operating Costs for the Leased Premises and payments in respect thereof shall commence upon the date the Landlord gives possession of the Replacement Premises to the Tenant; and

 

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  14.4.5 all the terms and conditions of this Lease, with appropriate amendments to reflect the nature of the building in which the Replacement Premises are located and except as are inconsistent with the terms and conditions of this Section 14.4, shall apply to the Replacement Premises.

 

15. SUBLET AND ASSIGNMENT

 

  15.1 Tenant’s Right to Sublet and Assign - Subject to the provisions hereinafter contained in this Article 15 and notwithstanding any law or statutory provision to the contrary, the Tenant shall have no right to assign its rights hereunder, in whole or in part, or to sublease the whole or any part of the Leased Premises, unless the Tenant shall have obtained the prior written consent of the Landlord to such assignment or sublease, which consent shall not be unreasonably or arbitrarily withheld or delayed. Without limiting or restricting in any manner whatsoever the Landlord’s right to refuse its consent on other reasonable grounds, including without limitation, where such assignee or sublessee does not agree to such reasonable conditions as may be imposed by the Landlord, it is expressly understood and agreed that refusal by the Landlord to grant its consent shall be deemed reasonable:

 

  15.1.1 where the occupant, transferee, assignee or sublessee proposed by the Tenant is then a tenant of premises in the Building or in another building owned by the Landlord and the Landlord has or will have during the next ensuing twelve (12) months suitable space for rent in the Building or in a comparable building owned by the Landlord;

 

  15.1.2 where the occupant, transferee, assignee or sublessee is not satisfactory to the Landlord in regard to financial standing, reputation, business experience or type and quality of business to be carried on;

 

  15.1.3 where the nature of the business to be conducted by the assignee or sub-tenant is not a permitted use under the provisions of Section 6.1 hereof or does not comply with the master plan of the City of Saint-Laurent for the Technoparc Saint-Laurent;

 

  15.1.4 where the proposed assignee or sub-tenant does not intend to, bona fide, physically occupy and carry on business from the Leased Premises;

 

  15.1.5 where the proposed subletting or assignment relates to a part of the Leased Premises only and in the Landlord’s sole judgment is not a proper or rational division of the Leased Premises:

 

  15.1.6 where the period of time for which the Leased Premises or part thereof is to be sublet or assigned is less than the remainder of the Term and in the Landlord’s sole judgment is not satisfactory;

 

  15.1.7 where the Rent payable under the sublease or the assignment is at a lower rate than the Rent payable hereunder;

 

  15.1.8

where the proposed assignment or sublease (a copy of which must be provided to the Landlord in accordance with Section 15.5) does not contain such provisions as the Landlord may reasonably require and is not satisfactory, in form and content to the Landlord and its legal counsel.

 

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Notwithstanding any provision herein to the contrary, the Tenant acknowledges and agrees that it shall not be entitled to assign this Lease or sublet the whole or any part of the Leased Premises prior to occupancy thereof.

 

  15.2 Assignment to a Creditor of Tenant - In the case of any assignment (which term, for greater certainty, shall include any hypothec, encumbrance or charge) of the Tenant’s right, title or interest hereunder or in and to the Leased Premises or any part thereof to a creditor of the Tenant, the Landlord may refuse its consent, without in any manner whatsoever restricting the Landlord’s right to refuse its consent on other reasonable grounds, where such assignee/creditor of the Tenant does not agree to the following conditions and such other reasonable conditions as may be imposed by the Landlord and the Tenant does not agree to pay all legal expenses incurred by the Landlord in connection with the approval of such assignment:

 

  15.2.1 that such assignee/creditor shall not be entitled to further assign or sublet the Tenant’s interest without complying with the provisions of this Article 15;

 

  15.2.2 that such assignee/creditor shall observe all the provisions of this Lease as if it was the Tenant including, without limitation, the payment of Rent and the restrictions on use of the Leased Premises;

 

  15.2.3 that such assignee/creditor shall not be entitled to enforce its security without giving the Landlord at least ten (10) days prior written notice;

 

  15.2.4 that in the event that such assignee/creditor enforces its security, it shall be responsible to pay all arrears of Rent, if any, owing at the time by the Tenant; and

 

  15.2.5 that such assignment contain such other provisions as the Landlord may reasonably require and its form and content be approved by the Landlord and its legal counsel.

 

  15.3 Non-Waiver - The consent of the Landlord to any assignment or sublet, shall not constitute a waiver of this Article 15 and shall not be deemed to permit any further assignment or sublet by another.

 

  15.4 Solidarily Liability - In the event that consent to any sublet or assignment is solicited by the Tenant and granted by the Landlord and the Tenant assigns all or part of its rights hereunder, or sublets all or part of the Leased Premises, the Tenant shall, notwithstanding such assignment or sublet, remain solidarily liable with the assignee or sublessee for the full performance of all of the obligations, terms and conditions of this Lease on the part of the Tenant to be performed in the same manner and to the same extent as if the said assignment had not been made or the said sublet not granted, the Tenant hereby waiving the benefits of division and discussion. The Tenant shall not be released in any manner whatsoever from performing any of the obligations, terms or conditions of this Lease.

 

  15.5

Request for Landlord’s Consent - If the Tenant requests the Landlord’s consent to any assignment or subletting of the whole or any part of the Leased Premises, such request shall be in writing and shall set forth all the terms and conditions of the proposed assignment or sublet (a copy of the proposed assignment or sublease to be provided to the Landlord) and shall be accompanied by the name and address of the proposed assignee or sub-tenant (and his/her birth date if an individual) together with such information as to the nature of the business and financial responsibility and standing of such proposed assignee or subtenant as the Landlord may reasonably require in order to make a reasonable determination. The Tenant’s request for consent shall also be accompanied by: (i) an unconditional and irrevocable written undertaking

 

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from the Tenant to the effect that the Tenant will reimburse the Landlord upon demand for all reasonable costs and expenses incurred by the Landlord to study the Tenant’s request, said costs and expenses to be payable as Additional Rent, whether the Landlord’s consent is granted or not; (ii) the waiver by the proposed subtenant of its rights under Article 1876 of the Civil Code of Quebec; and (iii) the consent of the proposed sublessee or assignee permitting the Landlord to collect, obtain and exchange personal and financial information in respect of the proposed sublessee or assignee. The Landlord shall within thirty (30) days from the receipt of the foregoing information and documents (and any and all other information and documentation which the Landlord may reasonably require in order to make its determination), notify the Tenant in writing either that (a) it consents or does not consent in accordance with the provisions and qualifications of this Article 15, to the proposed sublet or assignment and if it consents, the conditions on which its consent is given, or (b) it elects to terminate this Lease for that portion of the Leased Premises thus offered for sublet or assignment or for the whole of the Leased Premises if the proposed sublet or assignment is in respect of the whole thereof by giving to the Tenant a notice of its intention to so terminate and fixing a date of termination (such termination date to be not sooner than sixty (60) days nor more than ninety (90) days following such election and communication to the Tenant). If the Landlord elects to terminate this Lease as aforesaid, the Tenant shall deliver vacant possession of the Leased Premises or such portion thereof offered for sublet or assignment to the Landlord on the date indicated as the date of termination in such election, and this Lease, with respect to the whole of the Leased Premises or for that portion of the Leased Premises thus offered for sublet or assignment (as the case may be), shall thereupon terminate on such date. Should the Landlord not exercise its right to terminate this Lease as aforesaid, the Landlord shall not thereby be precluded from withholding its consent to the assignment or sublet provided such consent is not unreasonably withheld. No assignment or sublease shall take place nor be deemed to be consented to by reason of the failure of the Landlord to give notice to the Tenant within the aforesaid thirty (30) day period and the Tenant specifically waives the provisions of Article 1871 of the Civil Code of Quebec. Should the Landlord consent and should the Tenant’s proposed assignment or subletting not materialize during the delay stipulated in the Landlord’s consent, then the Landlord’s consent shall be deemed to have lapsed upon the expiry of such stipulated delay and the Tenant shall be required to begin again the process prescribed in this Article 15. Furthermore, the consent by the Landlord to any assignment or sublet shall not constitute a waiver of this Article 15 and shall not be deemed to permit any further assignment or sublet.

 

  15.6 Deemed Assignment or Sublet Without limitation, the Tenant shall, for the purposes of this Article 15, be considered to assign or sublet in any case where:

 

  15.6.1 the Leased Premises or any portion thereof or any business carried on therein are occupied or used or carried on by persons other than the Tenant, its employees and others engaged by the Tenant in carrying on the business of the Tenant, whether pursuant to an assignment, sublease, license, franchise or other right or whether any of the foregoing occurs by operation of law or otherwise;

 

  15.6.2 there is a parting with or sharing of the possession of all or any part of the Leased Premises whether by operation of law or otherwise;

 

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  15.6.3 any change in the control (voting or otherwise) of the Tenant is acquired or exercised by any person not having effective control of the Tenant at the date of execution of this Lease, save if the Tenant becomes a publicly listed corporation. The Tenant represents that as of the date of execution of this Lease by the Tenant, the shares of the Tenant are held as follows:

 

Major Shareholders

   2002 %    2003 %
Canadian Medical Discoveries Funds Inc.    21.3    15.0
Fonds de Solidarité des Travailleurs du Québec (FTQ)    19.0    18.9
GeneChem Technologies Venture Fund LP    15.8    10.6
Sofinov    15.5    22.0
Sea Flower    15.5    22.0
T2C2    4.6    6.6
Employees    8.3    4.9

Any “change in control” of the shareholders or in the share holdings of the Tenant from the above, shall be considered to be an assignment of this Lease and shall require the prior written approval of the Landlord, such consent not be unreasonably withheld.

For the purposes hereof, “change of control” shall mean that any person (including any of the abovementioned shareholders) acquires or holds securities of the Tenant to which there is attached more than fifty percent (50%) of the votes that may be cast to elect directors of the Tenant. Provided that any change in control of the shareholdings of the Tenant if the Tenant is a publicly listed company whose shares are traded publicly on a recognized stock exchange shall not be considered an assignment of the Lease.

 

  15.6.4 the Tenant hypothecates, encumbers or charges the whole of or any of its right, title or interest under this Lease or in and to the Leased Premises or any part thereof; or

 

  15.6.5 there is a corporate reorganization of the Tenant or where the corporate reorganization of the Tenant involves the assignment or transfer of all or substantially all of the Tenant’s assets to another corporation or the merger or amalgamation of the Tenant with another corporation. The Tenant shall, in the event of such assignment or transfer of all or substantially all of its assets or its merger or amalgamation with another corporation, deliver to the Landlord, in addition to the information required to be delivered to the Landlord pursuant to Section 15.5 hereof, copies of the most recent financial statements or opening financial statements of the proposed assignee or successor corporation and such further and other information in respect of the proposed assignee or successor corporation as may be requested by the Landlord.

 

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  15.6A Exceptions Personal to Phagetech Inc. - Notwithstanding the foregoing provisions of Section 1 5 .6.3, the following events shall not be deemed to be an assignment of the Lease or a sublease of the Leased Premises and consequently the Landlord’s consent shall not be required and the Landlord shall not have the right to cancel the Lease in lieu of giving its approval to the sublease or assignment, if and only if the following conditions are met:

 

  15.6A.1 In the case of a merger, acquisition or other form of corporate reorganization of the Tenant in the context of a bona fide fiscal plan or corporate reorganization (and for greater certainty, not in the case of a reorganization in an insolvency or a bankruptcy situation) or in the case of the sale of the Tenant’s business, provided that the entity that will result from such merger, acquisition or other form of corporate reorganization or provided that the entity that will buy the Tenant has a financial standing in the Landlord’s opinion and that of its auditors, acting reasonably, equal to or better than that of the Tenant as at the date of entering into this Lease. In that respect, the Tenant shall provide concurrently to the Landlord, at the time of giving prior written notice of such proposed merger, acquisition, corporate reorganization or sale (which prior notice must be given at least thirty (30) Business Days prior to the same) a copy of the Tenant’s most recent financial statements with a copy of the opening financial statements of the entity that will result from the merger, acquisition or proposed corporate reorganization or a copy of the buyer’s financial statements, as the case may be, in each case, prepared by a recognized firm of accountants or auditors. Moreover, in each of the above cases (provided the Tenant continues to exist as a distinct entity following the proposed transaction) the Tenant shall remain solidarily responsible for all its obligations pursuant to the Lease. If in the Landlord’s opinion and that of its auditors, the financial standing of the said entity is not equal to or better than that of the Tenant as aforesaid, then the Landlord’s consent shall be required and the Landlord shall inter alia have the right to cancel the Lease in lieu of giving its approval.

In the context of the exception described above, it is agreed that the deposit (set forth in Section 30 hereof) and the Letter of Credit (set forth in Section 33.1 hereof) may be replaced by an equivalent deposit and an equivalent Letter of Credit by the new entity that will become the Tenant.

 

  15.6A.2 In the case of emission, sale or other disposition of the Tenant’s shares between the current shareholders or to an entity which is affiliated with the Tenant (in accordance with the provisions of the Canadian Business Act ) as part of a bona fide fiscal plan or corporate reorganization provided that any such emission, sale or other disposition does not result in a change of control of the Tenant.

The Tenant acknowledges that the above exceptions set out in this Section 15.6A are personal to Phagetech Inc. and to any company that shall succeed to the Tenant or to any entity that may result from the events described in the exceptions above and that said exceptions may not be transferred nor exercised by any assignors of the Lease or sublessees of the whole or part of the Leased Premises.

 

  15.7 Limitation on Rights Transferred or Assigned - The Tenant acknowledges that the rights and options provided in Schedule “E” annexed hereto are personal to Phagetech Inc. and any entity permitted by Section 15.6A.1 and may not be transferred to nor exercised by any assignee of the Lease nor to any subtenant of the Leased Premises or any part thereof.

 

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  15.8 Transfer of the Property by Landlord - In the event of the sale, lease or other transfer or disposition by the Landlord of the Building, the Property, the Lands or any part thereof or the assignment by the Landlord of this Lease or any interest of the Landlord hereunder, and to the extent that the purchaser, lessee or assignee assumes the obligations of the Landlord hereunder, the Landlord shall, thereupon ipso facto and without further agreement, be freed and relieved of all liability with respect to such obligations. In the event of any sale, lease, transfer, disposition or assignment by the Landlord, the Tenant agrees, if requested by the Landlord, to provide replacement letters of credit in the name of the purchaser, lessee, transferee or assignee, for any letters of credit then held in the name of the Landlord.

 

16. DEFAULT OF TENANT

 

  16.1 Event of Default - Each of the following events (hereinafter called an “Event of Default”) shall be a default hereunder by the Tenant and a breach of this Lease:

 

  16.1.1 if the Tenant shall be in default under any provision of this Lease providing for the payment of Rent (whether Basic Minimum Rent or Additional Rent) hereunder when due and such default shall continue for five (5) days or longer;

 

  16.1.2 if the Tenant (i) files any proposal; or (ii) makes or attempts to make any assignment for the benefit of creditors; or (iii) takes or makes or attempts to take or make any arrangement or compromise with its creditors; or (iv) becomes bankrupt; or (v) takes or attempts to take the benefit of or becomes or attempts to become subject to any legislation that may be in force relating to bankrupt or insolvent debtors; or (vi) if a petition in bankruptcy is granted against the Tenant; or (vii) if any application, petition, certificate or order is granted for the winding-up or dissolution or liquidation, voluntary or otherwise, of the Tenant or of its assets or (viii) if a receiver or receiver-manager or trustee or sequestrator is appointed for its property, or any part thereof; or (ix) if the Tenant takes any steps or suffers any order to be made for its winding-up or other termination of its corporate existence;

 

  16.1.3 if any insurance policy upon the Property, the Building, the Lands or any part thereof from time to time effected by the Landlord or the Tenant shall be cancelled or about to be cancelled by Landlord or Tenant’s insurer by reason of the use or occupation of the Leased Premises by the Tenant or any assignee, sub-tenant or licensee of the Tenant or anyone permitted by the Tenant to be upon the Leased Premises or if the Tenant fails to effect insurance required to be maintained by it hereunder and if the Tenant further fails within forty-eight (48) hours after receipt of notice in writing from the Landlord to effect such insurance or to take such immediate steps in respect of such use or occupation as shall enable the Landlord or Tenant to reinstate or avoid cancellation (as the case may be) of such insurance policy,

 

  16.1.4 if the Leased Premises shall, without the prior written consent of the Landlord, be used by any persons other than the Tenant or its permitted assignees or permitted subtenants or for any purpose other than that for which they were leased or occupied or by any persons whose occupancy is prohibited by this Lease;

 

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  16.1.5 if the Leased Premises shall be vacated, abandoned or remain unoccupied (save as permitted by Section 5 of Schedule “E” annexed hereto in the case of where the Tenant is Phagetech Inc.,) without the prior written consent of the Landlord for five (5) consecutive days or more while capable of being occupied;

 

  16.1.6 if a writ of execution is issued against the goods or property of the Tenant or this Lease or if any of the goods or movable property on the Leased Premises are the subject of a notice of crystallization, an advance registration, a prior notice of hypothecary right or are seized in execution, before or after judgment or otherwise, by any creditor of the Tenant unless, in the case of seizure before judgment, the Tenant diligently contests such seizure and deposits with the Landlord such security as requested by the Landlord in respect of such seizure;

 

  16.1.7 if any legal hypothec or prior claim is registered against the Leased Premises or any part thereof or the property located therein by reason of any act or omission of the Tenant;

 

  16.1.8 in the event that the Tenant shall be in default in observing any other covenant herein contained (other than as provided in any of Subsections 16.1.1 to 16.1.7, inclusive) or in performing any of its other obligations contained in this Lease and such default shall not be cured within ten (10) days after written notice specifying such default is given to the Tenant by the Landlord, unless such default is incapable of being remedied with due diligence within such period of ten (10) days, in which case, if the Tenant has failed to commence to remedy such default within such ten (10) day period and thereafter to prosecute with due diligence the curing of such default until it is remedied.

 

  16.2 Landlord’s Recourses - In the event of an occurrence of an Event of Default, the Landlord may recover from the Tenant, without prejudice to the Landlord’s other rights and recourses, all arrears and amounts due hereunder, and moreover the current month’s Basic Minimum Rent plus Additional Rent plus the next ensuing six (6) month’s Basic Minimum Rent and Additional Rent shall immediately become due and payable. Furthermore, the Landlord may, without prejudice to any other rights or recourses it may have, terminate ipso facto this Lease without any formalities, notice or judicial proceedings and take immediate possession of the Leased Premises, in which case the Term of this Lease will, without prejudice to the Landlord’s other rights hereunder or by law, forthwith become forfeited and terminated and no payment or acceptance of rental subsequent to such termination will give the Tenant the right to continue occupancy of the Leased Premises or in any way affect the rights of the Landlord hereunder and the Tenant, upon said termination, shall thereupon peaceably surrender the Leased Premises to the Landlord. If the Landlord at any time terminates this Lease for any breach or by reason of the occurrence of an Event of Default or if any legal action is taken for the recovery of possession of the Leased Premises or for the recovery of any amount due under this Lease, the Landlord, in addition to any other remedies it may have hereunder or by law, may recover from the Tenant all damages and all expenses it may incur or suffer by reason thereof including, without limitation, attorney’s fees and legal costs and the cost of repossessing and reletting the Leased Premises.

 

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  16.3 Landlord’s Right to Repossess the Leased Premises - Upon the occurrence of an Event of Default, the Landlord may, without notice to the Tenant and without prejudice to any other right of the Landlord hereunder or by law, enter and repossess the Leased Premises and it may use such force as it may deem necessary for that purpose and for gaining admittance to the Leased Premises and it may expel all persons and remove all property from the Leased Premises and such property may be stored in a public warehouse or elsewhere at the cost and for the account of the Tenant, the whole without the Landlord being considered guilty of trespassing or becoming subject to any prosecution or becoming liable for any loss or damage which may be occasioned thereby, any statute or law to the contrary notwithstanding.

 

  16.4 Landlord’s Right to Relet the Leased Premises - If the Landlord elects to repossess the Leased Premises as herein provided or if it takes possession thereof pursuant to legal proceedings or pursuant to any notice provided for by law, it may from time to time, either with or without termination of this Lease, make such alterations and repairs as may be necessary to order to relet the Leased Premises and relet the Leased Premises or any part thereof, either in the name of the Landlord or otherwise for a term or terms which may, if the Landlord chooses, be less or greater than the balance of the Term and at such Rent and upon such other terms and conditions as the Landlord, in its sole discretion, deems advisable, and the Landlord may grant reasonable concessions in connection therewith. Upon each such reletting all Rent received by the Landlord from such reletting shall be applied firstly to the payment of any indebtedness other than Rent due hereunder from the Tenant to the Landlord, secondly to the payment of any costs and expenses of such resetting, including legal costs, solicitors’ fees and brokerage fees and the expenses of keeping the Leased Premises in good order and of preparing the Leased Premises for reletting, thirdly to the payment of Rent due and unpaid hereunder, and the residue, if any, shall be held by the Landlord and applied in payment of other damages suffered by the Landlord as a result of the Event of Default and, if applicable, termination of this Lease.

 

  16.5 Landlord’s Rights to Cure Defaults - Notwithstanding the provisions of Section 16.1 hereof, if the Tenant shall default in the performance of any of its obligations under this Lease, the Landlord may from time to time, after giving such notice as it considers sufficient (or without notice in the case of an emergency), perform or cause to be performed any of such obligations and for such purposes may do such things as may be required, including, without limitation, entering upon the Leased Premises and doing such things upon or in respect of the Leased Premises or any part thereof as the Landlord reasonably considers necessary to remedy such default. All expenses incurred pursuant to this Section 16.5 shall be paid by the Tenant as Additional Rent forthwith upon demand together with an administration fee of fifteen percent (15%) thereof and shall bear interest at the Stipulated Rate of Interest. The Landlord shall not be liable to the Tenant for any loss or damage resulting from any such action or entry by the Landlord and the same shall not be considered a breach of any obligation for peaceable enjoyment contained in this Lease or implied by law.

 

  16.6 Cumulative Remedies - Mention in this Lease of any particular remedy or remedies of the Landlord in respect of any default by the Tenant shall not preclude the Landlord from any other remedy in respect thereof, whether available in law or to equity or by statute or expressly provided herein. No remedy shall be exclusive or dependent upon any other remedy, but the Landlord may from time to time exercise any one or more of such remedies generally or in combination, such remedies being cumulative and not alternative.

 

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17. SIGNS, EXHIBIT OF LEASED PREMISES

 

  17.1 For Sale Signs - The Landlord shall have the right, at all times during the Term of this Lease, to place upon the Leased Premises a notice of reasonable dimensions and reasonably placed so as not to interfere with the business of the Tenant, stating that the Building of which the Leased Premises form a part is for sale.

 

  17.2 For Rent Signs - The Landlord shall have the right, at all times during the nine (9) months immediately preceding the expiration of the Term, to place upon the Leased Premises a notice of reasonable dimensions and reasonably placed so as not to interfere with the business of the Tenant, stating that the Leased Premises are for rent.

 

  17.3 Exhibition of Leased Premises - Subject to giving prior notice to the Tenant, the Landlord shall have the right to exhibit the Leased Premises from time to time to any prospective hypothecary creditor or purchaser during reasonable business hours and, during the nine (9) months immediately preceding the expiration of the Term, to exhibit the Leased Premises to any prospective tenant.

 

  17.4 Exterior Identification - The Tenant may, at Tenant’s expense, erect one sign to identify its firm name outside the Building. The Landlord shall collaborate, at the Tenant’s costs, with the Tenant to obtain the required permit from the municipality. The design and location of such identification are subject to the master plan of the City of Saint-Laurent for the Technoparc Saint-Laurent and also the design criteria established for the Technoparc Saint-Laurent and the prior written approval of the Landlord’s Architect which approval will not be refused without reasonable grounds. This identification shall also be in conformity with all other applicable laws and regulations. The Tenant shall bear the cost of the installation, repair, maintenance and removal of any such sign, reasonable wear and tear excluded.

 

18. COMPLIANCE WITH LAWS AND REGULATIONS

 

  18.1 Tenant’s Obligation to Comply with Laws and Regulations - The Tenant shall, at its own expense, promptly comply with the requirements of every applicable statute, by-law, law or ordinance and with every applicable regulation or order with respect to the condition, equipment, maintenance, use or occupation of the Leased Premises including, without limitation, the making of any alteration, addition to or removal of any structure upon, connected with or appurtenant to the Leased Premises, whether or not such alterations or improvements be required on account of any particular use to which the Leased Premises, or any part thereof, may be put and whether or not such requirement, regulation, or law or order be of a kind now existing or within the contemplation of the parties hereto. In addition the Tenant shall comply with any applicable regulation, requirement, recommendation or order of the Insurers’ Advisory Organization of Canada, the Canadian Fire Underwriters’ Association or any body having similar functions or of any liability or fire insurance company by which the Landlord or the Tenant may be insured so as to maintain full insurance coverage and shall comply with all police, fire, health, safety and sanitary regulations or laws imposed by any governmental authority. Without limiting the generality of the foregoing, the Tenant agrees that it shall, at its sole cost and expense, promptly observe and comply with all requirements relating to controls imposed by governmental authorities for ambient air and environmental standards and shall observe and comply with all police, fire, health, safety and sanitary regulations or laws imposed by any governmental authority or required by fire insurance underwriters.

 

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The Tenant agrees to obtain all certificates required by any governmental authorities pertaining to the operation of its business in the Leased Premises, including without limitation, the operation of a laboratory and provide promptly to the Landlord copies thereof.

 

  18.2 Environmental Laws - The Tenant hereby warrants and represents that it shall comply at all times with all laws, regulations or notices pertaining to environmental protection and/or control. Without limiting the foregoing and any other provision of the Lease, the Tenant agrees to comply in all respects with all laws, ordinances, rules and regulations relating to the manufacture, storage, transport, use or disposal of contaminants, pollutants, toxic substances and hazardous materials and wastes (hereinafter called “Hazardous Substance”). As part of Tenant’s insurance, the Tenant shall be required to provide insurance coverage with regard to any potential environmental liabilities of the Tenant. The Tenant agrees to indemnify and hold the Landlord harmless from and against any and all claims, losses, costs, damages, liabilities, civil fines and penalties, criminal fines and penalties, expenses (including attorney fees), cleanup costs or other injury resulting from or arising out of the Tenant’s (including Tenant’s employees, contractors and agents) failure to comply with the foregoing obligations. The Tenant agrees to post and keep posted in a prominent location in the working area of the Leased Premises any memorandum or bulletin from the Landlord concerning Hazardous Substances. The foregoing indemnity shall survive the termination of this Lease and subsequent renewals and shall continue until the applicable statute of limitation or prescription runs out.

In addition to the foregoing the Tenant hereby agrees that:

 

  18.2.1 it shall not cause or permit any Hazardous Substance to be brought upon, kept or used in or about the Leased Premises or any part thereof other than which is reasonably necessary for the Tenant’s permitted use of the Leased Premises and that any such Hazardous Substance will be used, kept and stored in areas designated by the Landlord and in any event, shall be used, kept, stored and disposed of in a manner that complies with all environmental laws and regulations regulating the Hazardous Substance;

 

  18.2.2 it shall provide to the Landlord copies of any notices the Tenant receives of violation of or non-conformity with applicable environmental laws and regulations and shall promptly notify the Landlord of any such violation of or non conformity and of any spill or release of Hazardous Substances in or from the Leased Premises or the Property;

 

  18.2.3

the Landlord may, at any time and from time to time, inspect the Leased Premises (and on a prior notice of not less than one (1) Business Day, except in the case of emergency, in which case no notice is required) and the Tenant’s records for the purpose of identifying the existence, nature and extent of any Hazardous Substance on the Leased Premises and the Tenant’s manufacture, use, transport, storage and disposal of any Hazardous Substance, and the Tenant agrees to cooperate with the Landlord in its performance of such inspection. If the Landlord, acting reasonably, determines, following any such inspection, that further testing or investigation is required in order to monitor the Tenant’s compliance with any environmental laws and regulations, the Landlord may, at its option, require the Tenant, at the Tenant’s expense, to arrange for such testing or investigation, or may arrange for such testing or investigation itself, in which case the Landlord’s cost of any such testing or

 

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investigation shall be paid by the Tenant to the Landlord as Additional Rent within thirty (30) days of demand therefor, which demand shall include any invoices incurred by the Landlord in respect thereof and a copy of supporting documents;

 

  18.2.4 if any authority having jurisdiction shall require the cleanup of any Hazardous Substances held, released, spilled, abandoned or placed upon the Leased Premises or the Property or released into the environment by the Tenant in the course of the Tenant’s business or as a result of the Tenant’s use or occupancy of the Leased Premises, then the Tenant shall, at its own expense, prepare all necessary studies, plans and proposals and submit the same for approval, provide all bonds and other security required by such authorities having jurisdiction, carry out the work required, provide the Landlord full information with respect to proposed plans and the status from time to time of its cleanup work and comply with the Landlord’s reasonable requirements with respect to such plans;

 

  18.2.5 if the Tenant creates or brings to the Leased Premises any Hazardous Substance or if the conduct of the Tenant’s business shall cause there to be any Hazardous Substance at the Leased Premises then, notwithstanding any provision in the Lease or rule of law to the contrary, such Hazardous Substance shall be and remain the sole and exclusive property of the Tenant or of clients on behalf of whom the Tenant is providing services and shall not become the property of the Landlord notwithstanding the degree of affixation to the Leased Premises of the Hazardous Substance or the goods containing the Hazardous Substance, and notwithstanding the expiry or early termination of the Lease; and

 

  18.2.6 upon the expiration or early termination of the Term or any renewal thereof, the Tenant at its sole expense shall remove and dispose of all Hazardous Substances and all its storage tanks and other containers therefore brought by the Tenant, or otherwise due to or resulting from the use of the Leased Premises by the Tenant, in accordance with all environmental laws and regulations and in addition, to the extent it is required by the Landlord, and to the extent that such removal and disposal involves any excavation work at the Leased Premises, the Building, the Lands or the Property, the Tenant shall restore the Leased Premises, the Building, the Lands or the Property, as the case may be, to the same grade level as immediately prior to excavation, using only clean uncontaminated soil or other material satisfactory to the Landlord (taking into account applicable environmental laws then in force).

The Tenant undertakes has remitted to the Landlord, the environmental questionnaire attached hereto as Schedule “I”, duly completed, prior to occupying the Leased Premises and thereafter and throughout the Term or any renewal thereof, such environmental questionnaire will be updated as may be requested from time to time by the Landlord.

In addition and without prejudice to the Landlord’s other recourses hereunder or by law, in the event that the Leased Premises remain vacant or may only partially be occupied after the termination of this Lease directly or indirectly because of the breach by the Tenant of its obligations under this Section 18.2, then, notwithstanding such termination of the Lease and in addition to any damages which the Landlord may claim from the Tenant, the Tenant shall be deemed to continue to occupy the Leased Premises on a tenancy from month to month and shall continue to pay to the Landlord rent at a monthly rate payable in advance equal to two hundred percent (200%) of the monthly installment of Rent payable for the last month of the Term. Such

 

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month to month tenancy shall be deemed to continue until such time as a clean up of the Leased Premises has been completed, all repairs to the Leased Premises have been made, the Leased Premises, the Building, the Lands, the Property or any portion thereof have been restored to their original condition, less ordinary wear and tear, and the Tenant has paid for all damages.

 

  18.3 Landlord’s Representations - The Landlord hereby represents that as of the date of completion of the construction of the Building, the Building including the Lands, will comply with all relevant building and zoning by-laws then in force.

The Landlord shall provide the Tenant with a Phase I Environmental Assessment Report for the Lands. On the Delivery Date, the Landlord shall warrant that the Lands are free from Hazardous Substances (as defined below) to a level equal to the maximum permissible level consistent with land used for commercial or industrial purposes in accordance with environmental laws in effect at the Delivery Date.

The Landlord warrants that the Building will not be constructed with materials containing any contaminant or pollutant in excess of the levels permitted in policies of the Quebec Ministry of the Environment and Wildlife and any other applicable environmental legislation in effect at the date of completion of construction of the Building. This warranty and representation is limited to contaminants or pollutants as said terms are defined under applicable provincial laws, regulations or policies or municipal by-laws, codes or governmental ordinances as of the date of completion of construction of the Building.

To the extent that the Landlord is responsible for the maintenance, repair and replacement of any equipment which form part of the Landlord’s Work (including the HVAC) in accordance with the provisions of this Lease, the Landlord will remain responsible throughout the Term of the Lease for any damage (to the extent such damage is not due to the acts, omissions, fault or negligence of the Tenant) which is caused to the Property if the Landlord does not respect environmental protection laws in respect of such maintenance, repair and replacement.

If due to the failure of the Landlord to so comply with environmental protection law as provided above, the Tenant is not able to operate in the Leased Premises in a secure manner and without danger for the health of its employees in accordance with legislative norms then in effect, the Tenant will have the right, at its option, to require that the situation be corrected within a reasonable delay (taking into account the health risk for the Tenant), the whole at the sole cost of the Landlord, including any penalties, legal fees and clean-up costs. If the Landlord receives any notice of violation of or any non-conformity with any environmental protection laws from a competent public authority having jurisdiction over the Property, and provided that such notice received affects the occupation of the Leased Premises or the health of the occupants of the Leased Premises, then the Landlord agrees to send a copy of such notice forthwith to the Tenant. The Landlord will advise forthwith the Tenant of any spill or release of Hazardous Substances in or from the Property of which it has knowledge.

 

19. INDEMNIFICATION

 

  19.1

Limitation of Landlord’s Liability - Except if caused by the negligence of the Landlord, the Landlord shall not be liable or responsible in any way for any injury of any nature whatsoever that may be suffered or sustained by the Tenant or any employee, agent or customer of the Tenant or any other person who may be upon or in the Property, the Building, the Lands or any

 

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part thereof or for any loss of or damage to any property belonging to the Tenant or to its employees or to any other person while such property is on the Leased Premises or on the Property, or the Lands, or in the Building or any part thereof and, in particular (but without limiting the generality of the foregoing), the Landlord shall not be liable for any damage or damages of any nature whatsoever to any such property caused by reason of a breakdown or other cause or failure to supply adequate drainage or caused by snow or the removal thereof, or by the interruption of any public utility service or by steam, water, rain or snow which may leak into, issue or flow into or from any part of the Leased Premises or from the water, steam, sprinkler or drainage pipes or plumbing works of the same, or from any other place or quarter or for any damage caused by or attributable to the condition or arrangement of any electrical wiring or other wiring, nor shall the Tenant be entitled to any abatement or reduction of Rent under such circumstances in respect of any such condition or failure. Furthermore, the Landlord shall not be liable for any damage resulting from the disturbance of enjoyment of the Leased Premises by the act of any third person, lessee or any person permitted to be on the Leased Premises, or in the Building, or on the Lands or on the Property nor shall the Tenant be entitled to abatement or reduction of Rent or resiliation of the Lease as a result of such disturbance.

 

  19.2 Landlord’s Indemnity - Notwithstanding any other term, obligation or condition contained in this Lease including, without limitation, the Landlord’s obligation to repair and the Landlord’s obligation to take out insurance and the Tenant’s obligation to pay its share of the costs of insurance, the Tenant shall indemnify and save harmless the Landlord and all its servants, agents, employees, contractors and persons for whom the Landlord is in law responsible from and against any and all losses, claims, actions, damages, liabilities and expenses, including legal fees and disbursements in connection with loss of life, personal injury, damage to property or any other loss or injury whatsoever arising from or out of this Lease (except if the same is caused by the negligence of the Landlord), or any occurrence in, upon or at the Leased Premises, or the occupancy or use by the Tenant of the Leased Premises or the Property or any part thereof, or occasioned wholly or in part by an act or omission of the Tenant or of any of its servants, agents, employees, invitees, licensees, sub-tenants or of persons for whom the Tenant is in law responsible or by any one permitted (by act or omission or otherwise) to be on the Leased Premises, in the Building, on the Lands, or on the Property or any part thereof by the Tenant. If the Landlord, without fault on its part, should be made a party to any litigation commenced by or against the Tenant, then the Tenant shall protect, indemnify and hold the Landlord harmless and shall pay all costs and expenses and reasonable legal fees incurred or paid by the Landlord in connection with such litigation. The Tenant shall also pay all costs, expenses and legal fees that may be incurred or paid by the Landlord in enforcing the terms, obligations and conditions of this Lease.

 

  19.3 Landlord’s Servants, etc. - It is agreed that every indemnity, exclusion or release of liability and waiver of subrogation herein contained for the benefit of the Landlord shall extend to and benefit all of the Landlord’s servants, agents, employees and those for whom the Landlord is in law responsible; solely for such purpose, and to the extent that the Landlord expressly chooses to enforce the benefits of Section 19.2 for its servants, agents, employees and those for whom the Landlord is in law responsible, it is agreed that the Landlord is the agent for its servants, agents, employees and those for whom the Landlord is in law responsible.

 

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20. EXPROPRIATION

 

  20.1 Leased Premises Rendered Unsuitable for Conduct of Business - In the event of the expropriation or other forceable taking or condemnation by any competent authority for any purpose whatsoever of the whole of the Leased Premises or such part thereof which, in the reasonable opinion of the Landlord, will render the remainder unsuitable or insufficient for the economical conduct of the Tenant’s normal business operation, this Lease shall cease and terminate from the date the Tenant is forced to vacate the Leased Premises and all Rent and other payments for which the Tenant is liable hereunder shall be apportioned and paid in full to the date of such termination.

 

  20.2 Leased Premises Not Rendered Unsuitable for Conduct of Business . In the event of any expropriation or forceable taking or condemnation by any competent authority for any purpose whatsoever of a part only of the Leased Premises which does not, in the reasonable opinion of the Landlord after consultation with the Tenant, render the remainder of the Leased Premises unsuitable or insufficient for the economical conduct of the Tenant’s normal business operation, this Lease shall remain in full force and effect with respect to the remainder of the Leased Premises and the Landlord shall restore and repair the portion of the Leased Premises not expropriated to a tenantable condition. The Rent payable by the Tenant hereunder shall be reduced so as to give due allowance for the part expropriated according to the nature and extent of such part. For greater certainty, if such expropriation, forceable taking or condemnation affects the Lands only, there shall be no abatement of Rent.

 

  20.3 No Claim in Damages by Tenant - The Tenant shall have no claim in damages against the Landlord relating to or arising out of the expropriation, forceable taking or condemnation or arising out of the cancellation of this Lease. The Landlord and Tenant shall cooperate, each with the other, in respect of any public taking of the Leased Premises or any part thereof so that, subject to the following rights of the Landlord (which include, without limitation, the right to receive compensation for the Landlord’s Work, the Tenant’s Fit-Up and Tenant’s Leasehold Improvements), the Tenant may receive the maximum award to which it is entitled in law for relocation costs, business interruption and such other costs (including any required higher rent in new premises) that it may be entitled to receive from the expropriating authority and so that the Landlord may receive the maximum award for all other compensation arising from or relating to such public taking (including all compensation for the Tenant’s Leasehold Improvements, the Tenant’s Fit-Up and the Landlord’s Work which are the subject of the public taking) and any right of the Tenant to such compensation is hereby assigned to the Landlord.

 

21. PERMITS

 

  21.1 Approvals, Permits and Licences - The Tenant shall obtain and maintain all approvals, permits or licences required for its occupation of the Leased Premises and for the conduct of its business therein, the Landlord making no warranties whatsoever regarding zoning, permits or licences which maybe required by the Tenant. In this regard, the Landlord undertakes, at the cost of the Tenant, to assist the Tenant in obtaining required occupancy permits from the City of Saint-Laurent. Notwithstanding the foregoing, the responsibility to obtain such permits shall remain the sole responsibility of the Tenant.

 

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22. FORBEARANCE OR INDULGENCE

 

  22.1 Non-Waiver - The failure of the Landlord to insist upon strict performance of any of the agreements, terms, covenants and conditions hereof to be performed by the Tenant shall not be deemed a waiver of any rights or remedies that the Landlord may have and shall not be deemed a waiver of any subsequent breach or default of any such agreements, terms, covenants and conditions.

 

23. INTEREST

 

  23.1 Interest - Rent and all other sums payable by the Tenant to the Landlord hereunder shall, if not paid when due, bear interest at the Stipulated Rate of Interest from the date due until payment thereof.

 

24. [INTENTIONALLY DELETED]

 

25. MOVABLE HYPOTHEC

 

  25.1 Movable Hypothec - As collateral security for the fulfillment of the obligations, terms and conditions of this Lease (but without novation or in any manner, being construed as discharging or satisfying the Tenant’s obligations under this Lease nor of any other security given by the Tenant or others for the performance of the Tenant’s obligations hereunder), the Tenant hereby hypothecates, by way of a fixed movable hypothec, the Landlord hereto present and accepting, with effect as and from the date of this Lease, to the extent of the sum of Two Hundred and Twenty Thousand Dollars ($220,000.00), the universality of all the Movable Property of the Tenant, present or future, corporal or incorporal, situated in, on, about or near the Leased Premises. The Tenant shall furnish and maintain in the Leased Premises, throughout the Term, Moveable Property all free and clear of any hypothecs, conditional sales contracts and other encumbrances whatsoever, which has a value equal to or greater than the aforesaid principal amount of the hypothec plus twenty percent (20%) thereof. The hypothec created in this Lease shall subsist without reduction until complete performance by the Tenant of all its obligations under this Lease and the payment of the rentals and all other sums that may be payable by the Tenant to the Landlord pursuant to this Lease from time to time or pursuant hereto. Such hypothec shall rank ahead of all hypothecs, prior claims or rights of any nature or kind in favour of any and all creditors but after the Tenant’s financial institution in the circumstances as hereinafter provided in the penultimate paragraph of this Section. The costs of publishing this hypothec shall be borne by the Tenant. The Tenant also undertakes to execute such further and other forms and documents that may be necessary in order to give effect to the provisions of this Section 25.1 and the hypothec herein created.

For the purposes hereof, “Movable Property” shall mean all movable property, furniture, stock-in-trade, inventory, trade fixtures and equipment of whatsoever nature or kind, present or future, corporal and incorporal situated in, on, about or near the Leased Premises, including, without limitation, sums of money, shares, bonds, other securities, works of art, books and records and all indemnities payable pursuant to and rights resulting from all contracts of insurance relating to the aforesaid property but excluding any intellectual property rights or copyrights.

 

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Provided the Tenant is not in default, the Landlord agrees that if the Tenant from time to time wishes to obtain financing for its business (with a bona fide arms-length financial institution (including without limitation, a leasing company or manufacturer) and, if such financial institution requires as security for its loan, or other financing, a first-ranking movable hypothec, then the Landlord will postpone its hypothec in favour of such bona fide arms-length financial institution, but to the extent only of the amount of such financing and will execute documentation as reasonably necessary to give effect thereto, the whole at the cost of the Tenant.

If the Tenant shall be in default under the terms of this Lease, the Landlord, in addition to any other available remedy hereunder or at law, may exercise any or all of its hypothecary rights in respect of the Movable Property of the Tenant at any place to which the Tenant or other person may have removed such Movable Property in the same manner as if such Movable Property had remained upon the Leased Premises.

 

26. STATUS CERTIFICATES AND SUBORDINATION

 

  26.1 Landlord’s Right to Hypothecate or Assign its Rights - The Landlord declares and the Tenant acknowledges that the Landlord may hypothecate or assign its rights under this Lease to a lending institution or any Hypothecary Creditor or lender as collateral security for any loan and in the event that any such hypothec or assignment is given and executed by the Landlord and notification thereof is given to the Tenant, the Tenant hereby agrees that it will, if and whenever reasonably required to do so by the Landlord, subordinate this Lease to any such mortgage, hypothec or loan arranged by the Landlord on the security of the Leased Premises, provided the lender delivers to the Tenant a non-disturbance agreement in the lender’s form to the effect that, so long as the Lease is in good standing and the Tenant is not in default hereunder, the Tenant may remain in quiet possession of the Leased Premises.

 

  26.2 Tenant’s Obligation to Deliver Statements - The Tenant shall, at any time and from time to time upon not less than five (5) days’ prior notice, execute and deliver to the Landlord, in the Landlord’s form or as the Landlord may direct, a statement in writing certifying that this Lease has been validly executed and delivered by the Tenant pursuant to due corporate action properly taken by it and is unmodified and in full force and effect (or if modified, stating the modification and stating that the same is in full force and effect as modified), the Commencement Date and the termination date, the amount of the Basic Minimum Rent and any other amounts then being paid hereunder, the dates to which, by installment or otherwise, Rent and amounts and other charges payable hereunder have been paid, whether or not there is any existing default on the part of the Landlord of which the Tenant is aware and such other matters as the Landlord or Hypothecary Creditor or any prospective purchaser may reasonably request. Any such statement may be conclusively relied upon by any prospective purchaser or purchasers or by the Hypothecary Creditor.

 

27. LEGAL HYPOTHECS

 

  27.1

Tenant’s Obligation to Ensure that No Legal Hypothecs be Registered - The Tenant shall throughout the Term promptly pay all its contractors, suppliers and workmen for any work or services performed or materials supplied which might give rise to a legal hypothec and shall

 

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ensure that no legal hypothec is registered against the Building, the Lands, the Property or any part thereof. Should a legal hypothec be registered against the Building, the Lands, the Property or any part thereof as a result of work or services performed by or on behalf of the Tenant or as the result of materials supplied to the Tenant, the Tenant shall cause the legal hypothec to be discharged forthwith and should the Tenant fail to discharge same promptly, then in such event and in addition to any other right or remedy of the Landlord, the Landlord may, but shall not be obliged to, discharge the same by paying the amount claimed directly to the hypothecary creditor and the amount so paid, together with all costs and expenses including attorney’s fees incurred for the discharge of the legal hypothec together with an administration fee of fifteen percent (15%), shall be immediately due and payable by the Tenant to the Landlord as Additional Rent upon demand. Notwithstanding the foregoing, the Tenant may contest the validity or the amount of any such legal hypothec, provided such contestation is effected in good faith and with due diligence and provided further that the Tenant lodges with the Landlord security in the amount and of the nature determined by the Landlord, the whole subject to any and all requirements of the Hypothecary Creditor.

 

  27.2 Tenant’s Obligation to Obtain Renunciations or Cessions of Priority - The Tenant hereby agrees to obtain from all its architects, engineers, contractors, subcontractors, suppliers and workmen and from any other person which may be entitled to a legal hypothec, a renunciation of or (at the Landlord’s option) cession of priority for their respective legal hypothecs in connection with work performed or materials supplied in respect of the Leased Premises. If the Tenant is unable to obtain such renunciations or cessions of priority after having used reasonable efforts to do so, it shall place with the Landlord security in an amount considered sufficient and satisfactory to the Landlord in order to guarantee completion of the work and payment of the cost thereof.

 

28. PEACEABLE ENJOYMENT

Tenant’s Right to Peaceable Enjoyment - The Landlord agrees that the Tenant, upon paying the Rent covenanted to be paid herein and observing and performing all the covenants, agreements and conditions herein contained on the Tenant’s part to be observed and performed, may peacefully enjoy the Leased Premises during the Term of this Lease, subject, nevertheless, to all the provisions of this Lease. If the Lease is subordinated to the rights of an hypothecary creditor as contemplated by Section 26.1 hereof, the provisions thereof shall apply. If the Property is sold or there is an assignment of Lease, the Landlord will use its commercially reasonable efforts, at the expense of the Tenant, to obtain an agreement of peaceful enjoyment from the purchaser.

 

29. OUTSIDE AREAS

 

  29.1 Outside Areas - The Tenant shall not use any part of the Property which is not built upon for any purpose other than as may be designated by the Landlord. Without limiting the generality of the foregoing, the Tenant shall not use the exterior parking areas for any other purpose than the parking of automobiles and in the case of paved areas specifically designated by the Landlord as shipping and receiving areas for any other purpose than shipping and receiving goods to and from the Leased Premises. No outside storage is permitted.

 

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  29.2 Parking - The Tenant shall be entitled to park up to thirty (30) cars in the exterior parking lot situated on the Lands at no additional cost throughout the Term of the Lease and any renewal thereof. In no event shall any such parking spaces be in the designated areas for visitors’ parking and such parking spaces will not be reserved. There will be designated areas for visitors’ parking (same to be designated by the Landlord at its sole discretion) and the Tenant must comply with the same.

As part of the Landlord’s Work, the exterior parking shall be lit, paved and painted to show individual spaces. During the Term, the Landlord shall be responsible for the maintenance of the exterior parking, including the removal of snow, and such costs shall form part of the Operating Costs.

 

30. DEPOSIT

 

  30.1 Deposit - The Tenant has remitted to the Landlord, as a deposit, the sum of Forty Thousand Dollars ($40,000.00), including G.S.T. and Q.S.T. plus any Tenant’s Sales Taxes applicable thereto. Such deposit shall be security, in part, for the performance of all of the obligations and covenants of Tenant under this Lease, it being expressly understood, however, that such deposit shall not be construed as discharging or satisfying Tenant’s obligations under this Lease. If the Tenant is not otherwise in default of its obligations under this Lease, said deposit shall be applied to the payment of the Rent for the first month of the Term and thereafter, to the Rent for the last month of the Term. In order to secure the obligations of the Tenant under Section 18.2 hereof, any remaining balance of the said security deposit shall only be released to the Tenant three (3) months after the date on which the Term of the Lease expired. The Landlord may apply the said remaining balance of the security deposit towards the fulfillment of the Tenant’s obligations under Section 18.2 of this Lease.

 

  30.2 Application of Deposit - In the event of the termination or cancellation of this Lease prior to the expiration of the Term hereof, which termination is due to the fault of the Tenant, then the Landlord shall have the right, at its option, to apply any portion of the deposit not yet applied by the Landlord in accordance with Section 30.1 hereof to damages or other sums due hereunder or at law without prejudice to the Landlord’s rights to claim for accelerated rent or damages or other sums due.

 

31. MISCELLANEOUS

 

  31.1 Overholding - No Tacit Renewal - Notwithstanding Articles 1878 and 1879 of the Civil Code of Quebec or any law or custom to the contrary, the present Lease shall not be subject to tacit renewal and the Tenant is not to have the right to such occupancy beyond the expiry of the Term, unless the Landlord and the Tenant have agreed in writing on the terms and conditions of a renewal or extension prior to the expiry. In the event that the Tenant remains in possession of the Leased Premises after the expiry of the Term without a written agreement as provided above, such occupancy shall be deemed to be a tenancy from month to month and such continued occupancy shall be at a monthly rate payable in advance equal to two hundred percent (200%) of the monthly installment of Basic Minimum Rent payable for the last month of the Term, and the Tenant shall be required to pay its Proportionate Share of Taxes and Operating Costs and other Additional Rent provided herein. Such continued occupancy shall be without prejudice to the Landlord’s right to re-enter and take possession of the Leased Premises and remove the Tenant therefrom without notice or indemnity to the Tenant and without prejudice to the Landlord’s other recourses hereunder or by law.

 

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  31.2 Governing Law and Severability - This Lease shall be construed by and governed in accordance with the laws of the Province of Quebec. If for any reason whatsoever any term, obligation or condition of this Lease or the application thereof to any person or circumstance is to any extent held or rendered invalid, unenforceable or illegal, then such term, obligation or condition shall be deemed severable and divisible from the remainder of this Lease and its validity, unenforceability or illegality shall not affect, impair or invalidate the remainder of the Lease or any part thereof and such term, obligation or condition shall continue to be applicable to and enforceable against any other person or circumstance other than those to which it has been held or rendered invalid, unenforceable or illegal.

 

  31.3 Entire Agreement - This Lease together with the Schedules referred to herein and the Rules and Regulations adopted and promulgated by the Landlord pursuant to the provisions hereof set forth the entire agreement and understanding between the parties concerning the Leased Premises and the Tenant acknowledges that there have been no promises, representations, agreements, conditions or understandings, either oral or written, between the Landlord and the Tenant other than as herein set forth. Except as otherwise expressly provided, no subsequent alteration, amendment, change or addition to this Lease shall be binding upon the Landlord or the Tenant unless in writing and duly signed by the Tenant and the Landlord.

 

  31.4 Unavoidable Delay - In the event that the Landlord or the Tenant is delayed, hindered or prevented from the performance of any set or covenant required hereunder to be performed by it by reason of Unavoidable Delay, then the performance of such act or covenant by the Landlord or the Tenant (as the case may be) shall be excused for the period during which such performance is rendered impossible and the time for the performance thereof shall be extended accordingly. Notwithstanding the foregoing, provisions of this Section 31.4 do not cancel or postpone or delay the due date of any payment to be made by the Tenant hereunder or operate to excuse the Tenant from the prompt payment of Basic Minimum Rent or Additional Rent or other payments required to be made by it under the terms of this Lease.

 

  31.5 Commissions - The Tenant represents and warrants to the Landlord that no broker or agent introduced the Tenant to the Leased Premises or negotiated or was instrumental in negotiating or consummating the Offer to Lease (if any) entered into between the Landlord and the Tenant in respect of the Leased Premises nor this Lease on behalf of the Tenant other than Staubach, Leonard, McKeague Inc, (“SLM”). The Landlord shall be responsible for the payment of SLM’s fees. The Tenant agrees to indemnify and hold harmless the Landlord from all actions taken by any other brokers or agents retained by the Tenant (except those retained by the Landlord) for the payment of fees or commissions relating to the Offer to Lease (if any) entered into between the Landlord and the Tenant and this Lease.

 

  31.6

Registration - The Tenant shall have the right to register this Lease solely against such portion of the Property as described below in this Section 31.6 and solely by presenting a deed which shall constitute a separate document prepared specifically for registration in accordance with the provisions of Article 2999.1 of the Civil Code of Quebec. Such document presented for registration shall not contain any mention of the rental terms or other financial conditions contained in this Lease. The preparation of such document and registration of the same shall be at the Tenant’s own expense and only after the form and terms of the same shall have been approved by the Landlord, which approval shall not be unreasonably withheld nor delayed. The

 

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Tenant shall supply at its expense a registered copy of such notice to the Landlord. Upon the termination of this Lease, the Tenant shall radiate, at its expense, the registration of this Lease, the whole within thirty (30) days following such termination. If the Tenant fails to so radiate the Lease within such thirty (30) day period, the Tenant hereby expressly and irrevocably appoints the Landlord as attorney and representative for the Tenant for such purposes of radiating the Lease with full power and authority to radiate such registration and to execute and deliver in the name of the Tenant any instruments or documents required for such purpose, the whole at the Tenant’s expense. The obligation to pay such costs shall survive the termination of the Lease.

The sole property against which this Lease may be registered is lot 1 165 623 of the Cadastre of Quebec, Registration Division of Montreal.

 

  31.7 Solidarity - When several persons, companies, firms or entities are named as Tenant or Indemnifiers (if applicable), they are solidarily liable for the fulfillment of the obligations undertaken by the Tenant or the Indemnifiers, as the case may be, under the terms hereof, the whole without the benefit of division, discussion or subrogation.

 

  31.8 Successors and Assigns - All rights and liabilities herein granted to or imposed upon the respective parties hereto extend to and bind the successors and assigns of the Landlord and the heirs, executors, administrators and permitted successors and assigns of the Tenant, as the case may be. No right, however, shall enure to the benefit of any assignee or successor of the Tenant unless such successor or the assignment to such assignee has been made in accordance with Article 15 hereof. Provided further that any rights stated herein to be personal to Phagetech Inc. shall not enure to its assignees or sublessees.

 

  31.9 Relationship - The Landlord does not, in any way or for any purpose, including, without limitation, the provision of Article 13 of this Lease, become a partner of the Tenant in the conduct of its business or otherwise, or a joint venturer or a member of a joint enterprise with the Tenant and neither any provision contained herein nor any acts of the parties hereto shall create a relationship between the parties other than that of landlord and tenant.

 

  31.10 Financial and Corporate Information - The Tenant shall forward to the Landlord, prior to the Landlord beginning construction of the Leased Premises, a copy of its most recent audited financial statements and business plan. In addition and thereafter, every year during the Term of the Lease, the Tenant shall provide to the Landlord, within one hundred and twenty (120) days of the end of its financial year, a certified copy of its audited financial statements for the financial year just ended and the Landlord shall treat the same confidential in accordance with Section 31.8 hereof. Further, the Tenant shall, upon request and without undue delay, provide the Landlord with such information as to the Tenant’s financial standing and corporate organization as the Landlord or any Hypothecary Creditor may reasonably require.

 

  31.11

Personal Information - The Tenant hereby authorizes and acknowledges that the Landlord may establish a file containing personal information relating to the Tenant and/or any partner of the Tenant if the Tenant is a partnership, the object of such file being to maintain at all times throughout the term of this Lease, up to date personal and financial information regarding the Tenant and the partners of the Tenant, as the case may be. Such information shall be used in the administration, management, evaluation and enforcement of this Lease and may also be used for the purposes of obtaining and maintaining financing for the Property and/or Building and/or of the Landlord and/or for the purposes of the sale, transfer or other alienation of the Property, of

 

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the Building or of the Landlord’s interest therein. The Tenant agrees that the Landlord’s employees in charge of management and administration of this Lease or enforcement hereof, mandataries, insurers, lenders and internal and external auditors may have access to information collected on the Tenant. The Landlord shall keep such information at its offices situated at the address indicated in Subsection 32.1.1 of this Lease where the Tenant may have access to the file and, as the case may be, present a request for rectification. The Tenant also authorizes the Landlord to collect personal and financial information regarding its financial situation and that of the partners of the Tenant if the Tenant is a partnership and their respective abilities to fulfill their obligations hereunder from third persons, as the case may be, and to communicate it to any of the foregoing persons, any hypothecary creditor or lender of the Landlord (or of the Property, of the Lands or of the Building) and to any future assignee of the Landlord’s rights hereunder. Prior to contacting a third party to obtain any such personal information, the Landlord will notify the Tenant of its intention to so obtain said information from said third party. All such personal information obtained shall be treated in a confidential manner.

 

  31.12 Changes Requested by Hypothecary Creditor(s) - If a Hypothecary Creditor requires reasonable changes to this Lease, the Tenant shall execute such documents or other instruments necessary to give effect to such changes, provided no such change shall affect the Term, the location of the Leased Premises, the Rentable Area of the Leased Premises or any Basic Minimum Rent payable hereunder.

 

  31.13 Adequate Explanation - The Tenant declares that it has received from its legal counsel, sufficient explanation of the nature and extent of the terms and conditions of this Lease and of the obligations and rights deriving therefrom for the Tenant and for the Landlord. The Tenant further acknowledges that it had the opportunity to negotiate and that the provisions of this Lease were freely negotiated by it and, agrees that the provisions of this Lease shall be interpreted according to its fair construction and shall not be construed more strictly against either party.

 

  31.14 Authority - The Tenant represents and warrants that it is duly formed and in good standing and has full corporate or partnership power and authority, as the case may be, to enter into this Lease and has taken all corporate or partnership action, as the case may be, necessary to carry out the transaction contemplated herein, so that when executed, this Lease constitutes a valid and binding obligation enforceable in accordance with its terms. The Tenant shall provide the Landlord with corporate resolutions or other proof in a form acceptable to the Landlord, authorizing the execution of this Lease.

 

  31.15 Specific Waivers - The Tenant renounces by these presents the benefit of and waives its rights and recourses under Articles 1859, 1861, 1863(2), 1865, 1867, 1868, 1869 and 1883 of the Civil Code of Quebec .

 

  31.16 Waiver of Liability - Notwithstanding any law, usage or custom to the contrary, the Landlord shall not be liable to the Tenant for damages resulting from the act of a third person and the Tenant does hereby expressly renounce to any right or recourse it may have against the Landlord as a result of such act and, without limiting the generality of the foregoing, the Tenant renounces and waives its right to obtain a reduction of Rent, cancellation of the Lease or damages.

 

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  31.17 Waiver of Rights under Section 65.2 of the Bankruptcy and Insolvency Act - The Tenant hereby waives any right which it may have pursuant to or by virtue of Section 65.2 of the Bankruptcy and Insolvency Act, as the same may be amended, replaced or modified from time to time, to repudiate this Lease.

 

  31.18 Confidentiality - This Lease and any other related or inherent documents shall be treated in a strict and confidential manner and shall not be duplicated except for necessary steps in order to conclude this leasing transaction which include disclosure to the legal counsel of respectively the Tenant and the Landlord and disclosure to employees, investors, financial partners, bankers or other financial institutions respectively of the Tenant and the Landlord, where such disclosure is required in order for the normal carrying on of business of the Landlord or of the Tenant, as the case may be.

 

32. NOTICES

 

  32.1 Notices - All notices, statements, demands, consents, requests or waivers required or permitted to be given or made hereunder shall be in writing and shall be delivered by hand or mailed by prepaid registered mail or sent by telecopier, addressed:

 

  32.1.1 if to the Landlord, as follows:

Société Immobilière Technologique de Montréal Inc.

7150 Albert-Einstein

Suite 200

Saint-Laurent, Quebec

H4S 2C1

Attention:  Mr. Claude Normandeau

          Director

Telecopier number: (514) 956-2529

 

  32.1.2 if to the Tenant, as follows:

(i) Prior to the Commencement Date:

Phagetech Inc.

C.P. 387 Place du Parc

Montreal (Que)

H2W 2N9

Attention:  Ms. Dalal Manoli

          President and Chief Executive Officer

Telecopier number: (514) 282-9889

 

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(ii) After to the Commencement Date:

at the Leased Premises

Attention:  Ms. Dalal Manoli

          President and Chief Executive Officer

Any such notice, statement, demand, consent, request or waiver, if delivered, shall be deemed to have been given on the date of delivery, if mailed, on the third (3rd) Business Day following the date of mailing thereof as aforesaid and if sent by telecopier, on the first (1st) Business Day following the day of delivery thereof by telecopier. Either party may change its address, telecopier number or the name of the person indicated as the recipient by notice to the other in the manner aforesaid. In the event of interruption or threatened interruption in postal service, such notice shall be delivered addressed as aforesaid or sent by telecopier.

 

33. ADDITIONAL SECURITY

 

  33.1 Letter of Credit - In addition to the movable hypothec referred to in Article 25 of the Lease and the deposit referred to in Article 30 of the Lease, the Tenant has remitted to the Landlord, as additional security for the performance of all of the obligations of the Tenant under the Lease, an irrevocable transferable letter of credit issued in favour of the Landlord (the “Letter of Credit”) for an amount of Two Hundred and Twenty Thousand Dollars ($220,000.00), issued by a Schedule I Canadian chartered bank, and which shall be renewable annually. The Letter of Credit is similar, in form and substance, to the form of letter of credit annexed hereto as Schedule “G”. The Letter of Credit shall be maintained in force for its full amount from the date of its issuance and for the entire Term of the Lease.

The Landlord shall be entitled to demand payment of the Letter of Credit: (i) upon the occurrence of an Event of Default by the Tenant under the Lease; or (ii) if at any time the Tenant fails to deliver to the Landlord an irrevocable transferable letter of credit replacing or renewing the Letter of Credit at least thirty (30) days prior to the expiry date thereof, in form and substance similar to the Letter of Credit.

If at anytime, the Landlord has demanded payment of the Letter of Credit or any part of the Letter of Credit is applied against any amount due by the Tenant under the Lease or otherwise, the Tenant shall obtain and remit to the Landlord a replacement irrevocable transferable letter of credit, substantially on the same terms and conditions as the Letter of Credit and for an amount equal to the amount of the Letter of Credit immediately prior to the Letter of Credit being called upon by the Landlord and the Landlord will reimburse to the Tenant, the unused amount, if any, of the Letter of Credit.

It is expressly agreed and understood that the foregoing security is in addition to and not in novation of or derogation from any other security given under the Lease or in connection herewith and shall not be construed as a novation of or discharging or satisfying the Tenant’s obligations under the Lease. Such security, or any remaining balance thereof after the application thereof to any sums owing by the Tenant under the Lease, shall be released three (3) months after the date on which the Term of the Lease has expired.

 

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34. ADDITIONAL CLAUSES AND LANGUAGE

 

  34.1 Additional Clauses - The parties agree that the additional clauses set out in Schedule “E” annexed hereto form part of this Lease. The Tenant acknowledges that each of the rights and options provided under Schedule “E” annexed hereto are personal to Phagetech Inc. and any entity permitted by Section 15.6A.1 and may not be transferred to nor exercised by any assignee of the Lease nor to any subtenant of the Leased Premises or any part thereof.

 

  34.2 Language Clause - The parties declare that they have requested and do hereby confirm their request that the present agreement be in English; les parties declarent qu’elles ont exigé et par les présentes confirment leur demande que la présente convention soit rédigée en anglais.

IN WITNESS WHEREOF , the parties hereto have signed this Lease as of the date and at the place hereinabove first written.

 

     THE LANDLORD :
     SOCIÉTÉ IMMOBILIÈRE TECHNOLOGIQUE DE MONTRÉAL INC. by its mandatary Citec Administration Inc.
     Per:  

/s/ Daniel Bouffard

      

Daniel Bouffard

President

      
      
     Per:  

/s/ Claude Normandeau

      

Claude Normandeau

One of its Directors

      
      
     THE TENANT :
     PHAGETECH INC.
     Per:  

/s/ Dalal Manoli

      

Dalal Manoli

President and Chief Executive Officer

      
      

 

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Exhibit 10.9

OFFICE SUBLEASE AGREEMENT

THIS OFFICE SUBLEASE AGREEMENT (the “Lease”) is executed as of this 1 st day of March, 2007, by and between UNITED FARM FAMILY LIFE INSURANCE COMPANY (“UFFLIC”), an Indiana corporation, and UNITED FARM FAMILY MUTUAL INSURANCE COMPANY (“UFMIC”), an Indiana corporation (UFFLIC and UFFMIC jointly shall be referred to hereinafter as “Lessor”), and TARGANTA THERAPEUTICS CORPORATION, a Delaware corporation (hereinafter referred to as “Lessee”), and Lessee does hereby lease from Lessor the following described premises upon the terms and conditions hereinafter set forth.

Recitals

1. WHEREAS, UFFLIC is the tenant under a lease agreement with UFB Properties, an Indiana general partnership (“Prime Lessor”) dated November 1, 1998 (the “Prime Lease”), under which UFFLIC is leasing a portion of the building at 225 South East Street, Indianapolis, Indiana (the “Building”), which building is located on real estate described in Exhibit A, attached hereto and incorporated herein by reference (the “Real Estate”).

2. WHEREAS, UFMIC is leasing from Prime Lessor the remaining portions of the Building.

3. WHEREAS, UFFLIC and UFMIC, as lessees of one hundred percent (100%) of the rentable office space in the Building, wish, each as to their respective interests, to sublease certain suites or rooms in the Building to Lessee, and Lessee wishes to sublease these certain suites or rooms in the Building from Lessor.

Agreement

Article 1 . Premises .

Section 1.1 . Lessor hereby leases to Lessee and Lessee hereby leases from Lessor, suite numbered 390 on the 3rd floor of the Building, as indicated in Exhibit “B,” attached hereto and incorporated herein by reference (the “Premises”), together with the right to use parking spaces located in Lots 1, 2 and 3 , as indicated in Exhibit “F,” together with the right of tenant’s invitees to use the visitors parking areas (the above specified parking areas available for use only by Lessee and Lessee’s employees, licensees and invitees as applicable shall be referred to hereinafter as the “Parking Spaces”), together also with Lessee’s non-exclusive right, in common with other tenants of the Building, Lessor and Prime Lessor, and their respective employees, licensees and invitees to use the hallways and passageways on the third floor of the Building, the stairways and elevators in the Building leading to and from the third floor, the cafeteria located on the second floor of the Building, driveways, entrances, exits, truckways, pedestrian sidewalks and ramps, landscaped areas and other common areas located on the Real Estate (the Parking Spaces and the above referenced common areas shall be referred to hereinafter as the “Common Facilities”).

Article 2 . Term . The term of this lease (the “Term”) shall be for 39 (thirty-nine) months (or until sooner terminated as herein provided), commencing on June 1, 2007, and ending at midnight on August 31, 2010. Rent payment will commence three (3) months after the Commencement Date. In the event Lessor is unable to deliver possession of the Premises on June 1, 2007, Lessor shall not be liable for any damage thereby, nor shall this Lease be void or voidable, but Lessee shall not be liable for any rent until the earlier of (i) the date Lessee’s personnel first occupy any part of the Premises for the purpose of carrying on Lessee’s normal business functions, or (ii) the 30th day following the date on which Lessor provides Lessee with written notice that the Premises are ready for occupancy. In the event that the Lease commences on a date other than June 1, 2007, in accordance with the terms of this Article 2., the Term of this Lease shall expire, unless sooner terminated as herein provided, 39 (thirty-nine) months from the 1st day of the month after the date of such commencement. The dates on which the Term of this Lease commences and terminates, shall be referred to hereinafter respectively as the “Commencement Date” and the “Termination Date”.


Article 3 . Use, Occupancy and Condition of Premises .

Section 3.1 . Use and Occupancy . Lessee shall use and occupy the Premises for the purposes of operating a(n) General Office and for no other purpose without the prior written consent of Lessor. Lessee shall comply with and obey all directions of Lessor and Prime Lessor, including the Building and Common Facilities rules and regulations set forth on Exhibit C, attached hereto and incorporated herein by reference or any amendment to the Building and Common Facilities rules and regulations by Lessor or Prime Lessor (the “Building Rules and Regulations”). Lessee shall not do or permit anything to be done by Lessee’s agents employees, contractors, invitees or licensees in or about the Premises which will in any way obstruct, interfere or annoy other occupants of the Building, or increase the cost of insurance on the Building. Lessor shall have the right to tow any vehicles that are on the Real Estate in violation of posted signs, the Building Rules and Regulations or the terms of this Lease. Lessor shall not be responsible to Lessee for the nonperformance by any other Building occupant or visitor (except Lessor or those claiming by, through or under Lessor) of any or all Building Rules and Regulations.

Section 3.2 . Condition of Premises . Lessee agrees to accept the Premises in its present condition, except to the extent that Lessor concurrently with, or prior to, the execution of this Lease has agreed in writing to complete, perform alterations to or repair the Premises (the “Lessor’s Build-Out Obligations”). Lessor agrees to pay Lessee $30,000.00 toward the completion of the tenant improvements the Lessee is coordinating, such payment to be made at such time as Tenant has spent $30,000 on such work. The act of taking possession of the Premises shall in all events be conclusive evidence that Premises are in satisfactory condition at the time accepted by Lessee, provided that such acknowledgement shall in no way derogate from Lessor’s and Prime Lessor’s maintenance and repair obligations. After any acceptance of the Premises by Lessee, Lessee shall be responsible for any repair, alteration or renovation necessary to keep or bring the Premises in compliance with any and all local, state and federal codes, statutes, rules and regulations.

Article 4 . Rent .

Section 4.1 . Annual Rent . The Lessee shall pay as rent (the “Rent”) for the Premises without relief from valuation and appraisement laws:

11,533 total square feet

 

Commencement – Month 3

   $ 0.00   

Months 4-15

   $ 17.35/sf    $ 200,098.00 annually

Months 16-27

   $ 17.70/sf    $ 204,134.00 annually

Months 28-39

   $ 18.05/sf    $ 208,171.00 annually

Rent shall be payable in advance beginning with the first (1st) day (or the business day next closest to the first (1st) day) of the month in which the Commencement Date occurs and on the first (1st) day of each calendar month of the Term thereafter, at the office of Lessor, or such other place as Lessor may from time to time designate in writing. In the event that this lease commences or terminates on a day other than the first or last day of any calendar month, the Rent for each day of Lessee’s occupancy during such month shall be 1/30th of the succeeding or preceding month’s Rent, as applicable.

Article 5 . Services, Alterations and Repairs .

Section 5.1 . Services . Lessor shall furnish to the Premises such quantities of heat, air conditioning, water, electricity, elevator and janitorial service (the “Building Utilities and Services”) as may be reasonably necessary for the comfortable use and occupation of the Premises during normal business hours on generally recognized business days. This Lease does not include telephone or other telecommunication facilities or services, and Lessee shall be responsible directly to the provider of such services, including, if applicable, Lessor, for all fees, charges and other costs relating to installation and use of telephones and any and all other voice, data transmission, facsimile, video, teleconferencing or other telecommunications equipment, facilities or services desired by Lessee. No failure to furnish Lessee with the Building Utilities and Services, except as the result of the negligence or willful neglect of Lessor or its agents, employees or contractors, and no interruption or suspension of any such Building Utilities and Services by reason of governmental regulation, civil commotion, strike, energy shortages, riots, fire, accident or emergency, or for repairs, alterations or improvements considered desirable or necessary by Lessor or Prime Lessor, or for any other reason beyond the power and control of Lessor or Prime Lessor, shall be construed as an eviction of Lessee or work an abatement or diminution of Rent or render Lessor or Prime Lessor or its agents or employees liable for damages suffered by Lessee, or anyone claiming by, through or under Lessee by reason of any such failure, or release Lessee from any of

 

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its obligations under this Lease. Lessee agrees to pay as Additional Rent, based on the reasonable estimates of Lessor, the cost of all electricity consumed in excess of that used for standard lighting and office purposes (“Extraordinary Electricity Consumption”). Lessor shall estimate the amount of Lessee’s Extraordinary Electricity Consumption and Lessor makes no warranty or representation concerning the adequacy or availability of electric energy for Lessee’s present or future requirements for other than general business offices. Building Utilities and Services in excess of those stated in this Section 5.1 (“After Hours Services”) are available upon request to the extent that Lessor is able to provide them. In such event, Lessor, at its option, may elect to charge Lessee directly an amount reasonably estimated by Lessor for Lessor’s actual costs (without profit or markup) of providing Lessee with After Hours Services.

Section 5.2 . Alterations to Premises . Lessor shall not be obligated after the Commencement Date to make any alterations, additions, improvements or decorations to the Premises. In the event Lessor undertakes any such alterations, additions, improvements or decorations at the request of Lessee, Lessee shall bear the reasonable expense of such work and upon billing therefor, shall promptly remit the amount of such expense to Lessor. Lessee shall make no alterations, additions, improvements or decorations to the Premises, or affix or cause to be affixed to the Building, the Premises, or the windows of the Building, any sign, insignia or advertising without first obtaining the written consent of Lessor, provided Lessor shall not unreasonably withhold or condition its consent to alterations, additions, repairs, improvements, decorations or renovations which Lessee is obligated to undertake pursuant to Section 3.2 hereof. As to any other alterations, additions, improvements or decorations that Lessee may desire to make, Lessor shall not unreasonably withhold or condition its consent to the same, provided that the structure of the Building is not adversely affected thereby. Any such work approved by Lessor shall be done on behalf of Lessee by a contractor approved by Lessor in a good and workmanlike manner and in accordance with all local, state and federal codes, statutes, rules and regulations. If Lessor grants written permission to Lessee to install or affix any non-standard (as determined by Lessor) signs, insignia or advertising to or upon the Premises or the Building, Lessor shall have the right, but shall not be obligated, to repair and perform maintenance on such sign, insignia or advertising to insure that it is maintained in a good and presentable manner in harmony with the rest of the Building, and to charge the reasonable expense of such repair and maintenance to Lessee, to be paid after billing with Lessee’s next immediate Rent payment.

Section 5.3 . Repair of Premises . Lessor agrees to maintain the interior of the Premises in a condition comparable, in Lessor’s sole discretion, to first-class office space, and to maintain the exterior and structure of the Building in a manner comparable, in Lessor’s sole discretion, to good quality office space. Beginning on the Commencement Date and thereafter, and subject to Lessor’s obligations under this Lease, Lessee shall at all times, at Lessee’s sole cost and expense, keep the Premises and every part thereof in good condition, ordinary wear and tear excepted. If Lessee fails to do so within a reasonable time after notice from Lessor, Lessor may repair any damage to the Premises, Common Facilities and Building caused by Lessee, its employees or invitees and, except to the extent waived in Section 8 of this Lease, charge the expense of such repair to Lessee, which expenses shall be paid by Lessee as Additional Rent along with Lessee’s next immediate Rent payment.

Article 6 . Liens . Lessee shall not cause or permit any lien or statement of intention to hold a mechanic’s lien to be filed against the Premises or the Real Estate or any part thereof, nor against any interest or estate therein by reason of labor, services or materials claimed to have been performed or furnished to or for Lessee, or otherwise on account of any act of failure to act on the part of Lessee. If any statement of intention to hold a mechanic’s lien shall be filed, Lessor or Prime Lessor at their options may compel the prosecution of any act of foreclosure of such mechanic’s lien by the lienor. If any such statement of intention to hold a mechanic’s lien shall be filed and an action commenced to foreclose the lien, Lessee within forty-five (45) days after written demand by Lessor or Prime Lessor, shall cause the lien to be released by the filing of a written undertaking with a surety approved by the court and shall obtain an order from the court releasing the property from such liens. If any lien shall attach to the Real Estate or any part thereof, or interest or estate therein, as aforesaid, Lessor or Prime Lessor shall have the right but shall not be obligated, to pay up the full amount of such lien to cause its release, and such amount, together with interest thereon from the date of payment shall be deemed Additional Rent due and payable by the Lessee immediately. This provision shall not be deemed or construed to constitute consent by Lessor or Prime Lessor to any party to perform any labor or services, or furnish any materials for or upon the Premises, Building or Real Estate.

Article 7 . Assignment and Subletting . Lessee shall not assign, mortgage, encumber or transfer any interest in this Lease, or sublet the Premises in whole or in part, nor grant a license or concession in connection therewith without Lessor’s written consent, which consent shall not be unreasonably withheld or delayed. Notwithstanding any such Lessor consent, Lessee shall remain fully liable to perform under all of the terms and provisions of this Lease.

 

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Article 8 . Nonliability and Indemnification .

Section 8.1 . Lessee’s Personal Property . Lessee shall keep and maintain at its sole risk all equipment, personal property and other improvements on the Premises and trade fixtures installed, or on behalf of Lessee, in or upon the Premises at its sole risk. Except for matters arising from the negligent or willful acts or omissions of Lessor or Prime Lessor (and then subject to Section 8.3 below), Lessor and Prime Lessor, as the case may be, shall not be responsible for any damages to the equipment, personal property or trade fixtures of Lessee or anyone claiming by, through or under Lessee.

Section 8.2 . Lessee Public Liability Insurance . Lessee, at its sole expense, shall keep in full force and effect during the Term of this Lease, one or more policies of commercial general public liability insurance with respect to claims arising directly or indirectly from this Lease or Lessee’s activities in or about the Building, Common Facilities and Premises, and use and occupancy thereof by Lessee and Lessee’s employees, and invitees, having terms and conditions and a minimum limit of combined single limit coverage of bodily injury and property damage in an amount of not less than $1,000,000 per occurrence, and $2,000,000 aggregate. The company or companies issuing such policies of insurance shall be qualified to issue insurance in the State of Indiana and approved by Lessor (it being agreed that Lessee’s existing insurers are acceptable), and such policies shall contain a clause stating that the insurer will not cancel or change the insurance coverage without first notifying Lessor and Lessee thirty (30) days prior to such cancellation. Lessee shall deliver to Lessor prior to the Commencement Date a copy of the policy or certificate of insurance maintained by Lessee in accordance with this Section 8.2.

Section 8.3 . Lessee Waiver . Lessee hereby releases Lessor and Prime Lessor and their respective employees, agents, customers, invitees and licensees from any and all liability for any loss of or damage to property occurring in, on, about or to the Premise, by reason of fire or other peril which is insurable under a “special form” coverage insurance policy, regardless of cause, including the negligence of Lessor and Prime Lessor, and their respective employees, agents, customers, invitees and licensees. Lessee shall cause its property insurance carrier to include a clause in its insurance coverage whereby the insurer waives its right of subrogation against Lessor and Prime Lessor.

Section 8.4 . Lessor Waiver . Lessor hereby releases Lessee and its respective employees, agents, customers, invitees and licensees from any and all liability for any loss of or damage to property occurring in, on, about or to the Building or personal property within the Building, in each case excepting the Premises, by reason of fire or other peril which is insurable under a “special form” coverage insurance policy, regardless of cause, including the negligence of Lessee and its employees, agents, customers, invitees and licensees. Lessor shall cause its property insurance carrier to include a clause in its insurance coverage whereby the insurer waives its right of subrogation against Lessee. Lessor shall deliver to Lessee a similar written release and waiver by the Prime Lessor.

Section 8.5 . Indemnification . (a) Subject to Section 8.4 above, Lessee covenants to indemnify and save harmless, Lessor, Prime Lessor and their respective agents and employees from and against any and all liability, damages, expenses, fees, penalties, actions, causes of action, suits, costs claims or judgments arising from injury to person or property in the Building or Premises, or on the Real Estate, caused by any negligence or intentional act or omission of Lessee, its servants, contractors, employees, licensees and invitees.

(b) Subject to Section 8.3 above, Lessor covenants to indemnify and save harmless, Lessee and its respective agents and employees from and against any and all liability, damages, expenses, fees, penalties, actions, causes of action, suits, costs claims or judgments arising from injury to person or property in the Building or Premises, or on the Real Estate, caused by any negligence or intentional act or omission of Lessor, Prime Lessor or their respective servants, contractors, employees, and licensees.

Article 9 . Holding Over . If Lessee shall retain possession of the Premises with the written consent of Lessor after the expiration of the Lease Term, and Rent is accepted from Lessee, such occupancy and Payment shall be construed as an extension of the Lease for a period from month-to-month from the date of such expiration. In such event, if either Lessor or Lessee desires to terminate the Lease at the end of any month, the party desiring termination shall give the other party at least thirty (30) days written notice thereof. Failure on the part of Lessee to give such notice shall obligate Lessee to pay Rent for an additional calendar month, following the month in which Lessee vacates the Premises. If Lessee retains possession of the Premises after the expiration of this Lease without the written consent of the Lessor, Lessee shall pay the Lessor Rent in an amount double the monthly Rent applicable immediately prior thereto, computed on a daily basis, for the number of days the Lessee retains possession of the Premises or any part thereof after expiration or termination. This provision shall not be deemed to waive Lessor’s right to re-enter the Premises or exercise any other right hereunder, at law or in equity.

 

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Article 10 . Rights Reserved to Lessor . Lessor and Prime Lessor shall at all reasonable times have the right, upon reasonable notice to Lessee, to reenter the Premises in an emergency or to inspect the same, and to alter, improve, remodel or repair the Premises or any portion of the Building, without abatement of Rent and without incurring any liability to Lessee therefore. So long as Lessor and Prime Lessor have used reasonable efforts to avoid any interference with Lessee’s business operations in the Premises, Lessee hereby waives against Lessor any claim of damages for any injury or inconvenience to, or interference with, Lessee’s business, any loss of occupancy or quiet enjoyment of the Premises, and any other loss occasioned thereby.

Article 11 . Default .

Article 11.1 . Default . If (i) Lessee shall abandon or vacate the Leased Premises or fail to pay Rent at the time prescribed in this Lease, and such failure shall continue for five (5) business days, or (ii) if after fifteen (15) days written notice from Lessor, Lessee shall fail to cure any other default in the performance of its other obligations under this Lease (unless such default is not reasonably curable within fifteen (15) days, in which event Lessee shall not be deemed to be in default so long as Lessee shall commence to cure the default within the fifteen (15) day period and thereafter continuously and diligently proceed to complete the cure of such default within a reasonable time, not to exceed seventy-five (75) days:

(a) Lessor or Prime Lessor may take possession of the Premises, remove Lessee’s property and relet the Premises for a longer or shorter period than the remaining term of this Lease. Such repossession shall not terminate this Lease or Lessee’s obligations hereunder, absent termination notice from or reletting by Lessor, and all Lessor’s actual and reasonable our-of-pocket expenses incurred in connection with such repossession, removal and reletting, and any attempted reletting (the “Reletting Costs”), together with Interest on unpaid amounts shall be payable by Lessee as Additional Rent with the Rent payment next due. The net amount, if any, realized by Lessor from such reletting, shall be credited against the amounts owed by Lessee under this Lease.

(b) Lessor may terminate this Lease, effective immediately, upon termination notice to Lessee, and additionally, Lessor may immediately recover from Lessee all damages incurred by reason of Lessee’s default, including without limitation (i) the actual and reasonable our-of-pocket costs for recovering the Premises and removing Lessee’s property, (ii) Interest on unpaid amounts payable as Additional Rent, and (iii) reasonable Attorneys fees and court costs related to Lessor’s actions hereunder (the “Default Damages”), and Lessor may at its election also recover an amount equal to the then net present value (computed at the Wall Street Journal prime rate) of the excess (if any) of the Rents provided for in this Lease (together with Lessee’s share of Building Operating costs as estimated by Lessor) for the remainder of the stated Term over the actual rent obtained under any reletting or if no such reletting has taken place, the reasonable rental value of the Premises for such portion of the unexpired Term for which the Premises may reasonably be relet. If Lessor subsequently relets the Premises or attempts to relet the Premises, Lessor may recover immediately from Lessee all costs of reletting or attempted reletting.

(c) Lessor may cure the default for the account of Lessee, and if, in curing such default, Lessor reasonably pays any sum of money or incurs any expense, such actual and reasonable our-of-pocket sum or expense so paid shall be reimbursed with interest by Lessee upon Lessor’s demand.

(d) Lessee’s liability for the default damages and/or reletting costs shall survive any termination of this Lease.

Article 12 . Damage by Fire and Eminent Domain . If, during the Lease Term, the Building or the Common Facilities are so damaged by fire or other casualty or a part of all of the Real Estate is taken by, or conveyed under threat of, eminent domain proceedings, so that the Building or the Premises are rendered unfit for occupancy, (as determined by Lessor), and Lessor gives Lessee written notice to such effect, then this Lease shall cease and terminate from the date one day prior to the date of such damage or taking. In such event, Lessee shall pay the Rent apportioned to the time of termination, and shall immediately surrender the premises to Lessor. If following damage to the Premises or the Common Facilities caused other than by Lessee’s acts or omissions, Lessor gives Lessee written notice that it has determined that such damage can be repaired within one

 

5


hundred twenty (120) days from the date of damage, Lessor, if it so elects, may enter and repair the Premises, and this Lease shall not be affected except that the Rent shall be apportioned and suspended to the extent that Lessor deems reasonably equitable while such repairs are being made: provided, however, that if such partial destruction occurs during the final six ( 6 ) months of the Lease Term, Lessor shall not be obligated to repair the Premises and Lessor shall have the right to terminate this Lease upon fifteen (15) days notice to Lessee. If, however, such damage is caused by Lessee’s acts or omissions and Lessor elects to repair in accordance with this Article 12, then Lessee’s obligations to pay Rent shall not be suspended, nor shall Rent be apportioned, but Lessee shall be obligated to pay the full Rent in accordance with the terms of this Lease during such period of repair. If a portion of the Premises is condemned but the remainder is still suitable, or though repairs can be made suitable, for the use intended by this Lease, Lessor or Prime Lessor shall promptly make the necessary repairs and this Lease shall not terminate; provided, however, that if at the time of a partial condemnation less six ( 6 ) months of the Term remains, then Lessor shall have the right to terminate this Lease by giving Lessee fifteen (15) days notice of such election. If Lessor elects to make the necessary repairs, then a portion of the Rent for the rest of the Term shall be abated in proportion to the square footage of the leased Premises taken. All compensation paid to Lessor in connection with the condemnation of the Building or the Premises shall belong to and be the sole property of Lessor, except to the extent of any specific award for Lessee’s trade fixtures or for moving expenses. If Lessee’s obligation to pay Rent is completely abated for any period of time in accordance with the terms of this Article 12, then the Term of this Lease shall be extended for a period equal to the period during which Lessee’s Rent is completely abated.

Article 13 . Surrender of Premises . Upon the expiration or earlier termination of this Lease, Lessee shall remove all of its furniture, equipment, trade fixtures and other unattached movable personal property, and surrender the Premises to Lessor together with any and all improvements made to the Premises, whether by Lessee or Lessor, in the condition received by Lessee, excepting ordinary wear and tear or eminent domain or any matters that are the Lessor’s or Prime Lessor’s responsibility under this Lease or the Prime Lease. Any damage to the Premises caused by removal of Lessee’s property or fixtures, shall be repaired promptly, at Lessee’s sole expense. Any property of Lessee’s not removed within ten (10) days after the expiration or earlier termination of this Lease shall, at Lessor’s option, be deemed the property of Lessor. Lessor shall also have the right following such 10-day period, to remove and store property left by Lessee or dispose of property not removed by Lessee, and to recover from Lessee the cost of such moving and storage expenses. Lessee shall indemnify Lessor against any loss or liability resulting from Lessee’s delay in surrendering the Premises to Lessor, including without limitation, any claims made by any subsequent lessee, provided that Lessor shall have provided Lessee with ten (10) days’ prior notice of such subsequent lessee. Acceptance by Lessor of Lessee’s keys to the Premises, unaccompanied by Lessor’s express statement to such effect, shall not be interpreted as Lessor’s acceptance of Lessee’s surrender of the Premises.

Article 14 . Waiver . Waiver by Lessor of any term, covenant or condition contained herein shall not be deemed to be a permanent or continuing waiver of such term, covenant or condition, or as a waiver of any subsequent breach of the same or any other term, covenant or condition contained herein. The acceptance of Rent hereunder by Lessor shall not be deemed to be a waiver of any preceding Lessee breach of any term, covenant or condition of this Lease, other than the failure of Lessee to pay the particular Rent so accepted, regardless of Lessor’s knowledge of the preceding breach at the time of acceptance of such Rent.

Article 15 . Notices . All notices of demand which may or are required to be given by either party hereunder shall be in writing and shall be sent by United States certified or registered mail, postage prepaid, addressed to Lessee at the Premises, and addressed to Lessor at the office of Lessor or at such other firm or to such other place as Lessor may from time to time designate in writing.

For the Lessor:

Indiana Farm Bureau Insurance

225 S. East Street

Indianapolis, Indiana 46202

Attn: Joseph A. Martin

Fax: 317.692.7069

 

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For the Lessee:

Targanta Therapeutics Corporation

222 3 rd Street, Suite 2300

Cambridge, Massachusetts 02142

Attention: Chief Financial Officer

Fax: 617.577.9021

With copy to:

Langer & McLaughlin, LLP

137 Newbury Street, Suite 700

Boston, Massachusetts 02116

Attention: Stephen T. Langer

Fax: 617.536.9040

Article 16 . Incorporation of Prime Lease . This Lease, and the rights of Lessee herein, are subordinate and subject at all times to the terms and provisions of the Prime Lease and, except as may be inconsistent with the terms of this Lease, all of the terms, covenants and conditions contained in the Prime Lease shall be applicable to this Lease with the same force and effect as if Lessee was the Lessee under the Prime Lease; except that any reference in the Prime Lease to the “Leased Premises” shall be applicable to Lessee as if such term was referencing the Premises.

Article 17. Miscellaneous Provisions .

Section 17.1 . Governing Law . This Lease shall be governed by the laws of the State of Indiana.

Section 17.2 . Writing Controls . Lessee acknowledges that Lessor has not made any statement, promise or agreement, or taken upon itself any engagement whatsoever verbally or in writing in conflict with the terms of this Lease or that in any way modifies, varies, alters, enlarges or invalidates any of the provisions of this Lease, and no obligations of Lessor shall be implied in addition to the obligations stated herein.

Section 17.3 . Air and Light . This Lease does not grant or guarantee Lessee a continuance of light and/or air over any property adjoining or adjacent to the Premises.

Section 17.4 . Quiet Possession . Lessor covenants that, unless otherwise specifically limited herein, Lessee, upon payment of Rent herein provided and performance of all covenants and obligations of Lessee hereunder, shall have quiet possession of the Premises during the Term.

Section 17.5 . Memorandum of Lease . At the request of either party, the parties shall execute and record a memorandum of this Lease, the expense of which (including but not limited to, legal fees and expenses) shall be borne by the party making such a request.

Section 17.6 . Interest . Any reference to the term “Interest” in this Lease shall mean the lesser of 8 or the highest rate allowed by applicable law.

Section 17.7 . Jury Trial . Lessee agrees to waive its right to jury trial for any disputes, claims or causes of action which arise as a result of the relationship between Lessor, Prime Lessor and Lessee under this Lease and/or the Prime Lease, and no claim or complaint against Lessor hereunder shall be valid or enforceable against Lessor unless such claim or complaint is provided to Lessor in writing in accordance with Article 15 of this Lease.

Section 17.8 . Option to Extend the Lease . This Lease includes the option to extend this Lease for an additional 36 (thirty-six) months. Lessor shall provide Lessee with six (6) months’ advance written notice of Lessee’s intent to extend the Lease for the three (3) additional years. The rate for the space will increase $.35 per square foot for each year of the extension.

Section 17.9 . Broker Fees . This Lease contains no provisions for paying any broker fees beyond those for the initial 39 (thirty-nine) months of this Lease. Each party represents and warrants to the other that it has dealt with no broker or party to whom a commission or fee may be due with respect to this Lease, other than Colliers Turley Martin Tucker. Lessor shall be solely responsible for payment of any fee or commission due to David Moore. Each party will indemnify and hold the other

 

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harmless from and against any loss, cost, damage or expense (including without limitation reasonable attorneys’ fees and costs) suffered as a result of a breach by the indemnifying party of the foregoing representation and warranty.

The parties signing on behalf of the Lessor and Lessee below have been fully empowered by all necessary actions of Lessor and Lessee to execute and deliver this Lease. This Lease shall not be valid or effective against any of the parties hereto until all of the parties hereto have signed below.

 

LESSOR:
UNITED FARM FAMILY LIFE INSURANCE COMPANY
By:   /s/ Joseph A. Martin
Printed:   Joseph A. Martin
Title:   Senior Vice President
UNITED FARM FAMILY MUTUAL INSURANCE COMPANY
By:   /s/ Joseph A. Martin
Printed:   Joseph A. Martin
Title:   Senior Vice President
LESSEE: TARGANTA PHARMACEUTICALS
By:   /s/ George Eldridge
Printed:   George Eldridge
Title:   Chief Financial Officer

 

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CONSENT

UFB Properties hereby consents to this Office Sublease.

 

Prime Lessor:
UFB PROPERTIES
By:   /s/ Joseph A. Martin
Printed:   Joseph A. Martin
Title:   Senior Vice President

SCHEDULE OF EXHIBITS

Exhibit A Description of Real Estate

Exhibit B Diagram of the Premises

Exhibit C Building Rules and Regulations

Exhibit D Lessor’s Build-out Obligations from

Section 3.2 of Agreement

Exhibit E Intentionally Omitted

Exhibit F Parking lot

 

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Exhibit 10.10

CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

MANUFACTURING SERVICES AGREEMENT

This MANUFACTURING SERVICES AGREEMENT (“Agreement”) is made this 27 th day of March, 2007, by and between Cardinal Health PTS, LLC, having a place of business at 4401 Alexander Blvd NE, Albuquerque, NM 87107 (“Cardinal Health”) and Targanta Therapeutics, Corp. (“Targanta”), having its principal place of business at 225 South East Street, Suite 390, Indianapolis, IN 46202.

 

  A. Cardinal Health provides contract pharmaceutical development, manufacturing, packaging, analytical, and sales and marketing services to the pharmaceutical industry.

 

  B. Targanta has certain technology relating to the certain pharmaceutical products and wants Cardinal Health to assist in the formulation, filling, packaging and testing on such products as provided in this Agreement and the attachments hereto.

 

  C. Targanta desires to engage Cardinal Health to provide certain services to Targanta in connection with the processing of Targanta’s Product (defined below); and Cardinal Health desires to provide such services pursuant to the terms and conditions set forth in this Agreement.

NOW, THEREFORE, in consideration of the mutual covenants, terms and conditions set forth below, the parties agree as follows:

ARTICLE 1

DEFINITIONS

The following terms have the following meanings in this Agreement:

 

1.1 “Affiliate(s)” means any corporation, firm, partnership or other entity which controls, is controlled by or is under common control with a party. For purposes of this definition, “control” shall mean the ownership of at least fifty percent (51%) of the voting share capital of such entity or any other comparable equity or ownership interest.

 

1.2 “API” means the active pharmaceutical ingredient used in the manufacture of the Product as identified in the Specifications.

 

1.3 “Applicable Laws” means all laws, ordinances, rules and regulations within the Territory applicable to the Processing of Product or any aspect thereof and the obligations of Cardinal Health or Customer, as the context requires, including, without limitation, (i) all applicable federal, state and local laws and regulations of each Territory; (ii) the U.S. Federal Food, Drug and Cosmetic Act, and (iii) the Good Manufacturing Practices promulgated by the Regulatory Authorities, as amended from time to time (“GMPs”).


1.4 “Batch” means a specific quantity of a Product comprising a number of units of Product mutually agreed upon between the parties, and that (a) is intended to have uniform character and quality within specified limits, and (b) is Processed according to a single manufacturing order during the same cycle of Processing.

 

1.5 “Calendar Quarter” means a period of three (3) consecutive months commencing on January 1, April 1, July 1 or October 1 of any calendar year.

 

1.6 “Cardinal Health Materials” shall have the meaning set forth in Article 12.

 

1.7 “Change Order” shall have the meaning set forth in Section 4.5(a).

 

1.8 “Commencement Date” means the first date upon which a Regulatory Authority approves Cardinal Health as a manufacturer of one of the Products.

 

1.9 “Confidential Information” is as defined in Section 11.2.

 

1.10 “Contract Year” means each consecutive twelve (12) month period beginning on the Commencement Date.

 

1.11 “Targanta Materials” shall have the meaning set forth in Article 12.

 

1.12 “Defective Product” shall have the meaning set forth in Section 5.2.

 

1.13 “Delayed Approval Fee” shall have the meaning set forth in Section 7.4.

 

1.14 “Dispute” shall have the meaning set forth in Section 18.9.

 

1.15 “Dosage Container” means any final dosage form container(s) the parties may agree upon in writing from time to time.

 

1.16 “Effective Date” means the date this Agreement was fully executed.

 

1.17 “Facilities” means Cardinal Health’s facilities located in Albuquerque, NM, San Diego, CA and Philadelphia, PA or such other facility as agreed by the parties as identified more specifically in the Quality Agreement.

 

1.18 “FDA” means the United States Food and Drug Administration, and any successor entity thereto.

 

1.19 “Firm Commitment” shall have the meaning set forth in Section 4.2.

 

1.20 “Intellectual Property” means all intellectual property (whether or not patented), including without limitation, patents, patent applications, know-how, trade secrets, copyrights, trademarks, designs, concepts, technical information, manuals, standard operating procedures, instructions or specifications.

 

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1.21 “Minimum Requirement” shall have the meaning set forth in Section 4.1.

 

1.22 “Process”, “Processed”, or “Processing” means the sterile compounding, filling, producing and/or packaging of the API and Raw Materials into Product in accordance with the Specifications and the terms and conditions set forth in this Agreement.

 

1.23 “Processing Date” means the day on which the Product is to be first Processed by Cardinal Health.

 

1.24 “Product” means the fully compounded bulk drug solution Processed into Dosage Containers and packaged in accordance with the Specifications.

 

1.25 “Purchase Order” shall have the meaning set forth in Section 4.3.

 

1.26 “Raw Materials” means all raw materials, supplies, components and packaging necessary to manufacture and ship the Product in accordance with the Specifications, as provided in Exhibit A , but not including the API.

 

1.27 “Regulatory Approval” shall have the meaning set forth in Section 7.4.

 

1.28 “Regulatory Authority” means any governmental regulatory authority within a Territory involved in regulating any aspect of the development, manufacture, market approval, sale, distribution, packaging or use of the Product.

 

1.29 “Review Period” shall have the meaning set forth in Section 5.1.

 

1.30 “Rolling Forecast” shall have the meaning set forth in Section 4.2.

 

1.31 “Sample” shall have the meaning set forth in Section 5.1.

 

1.32 “Specifications” means the procedures, requirements, standards, quality control testing and other data and the scope of services set forth in the master batch record and/or master packaging batch record applicable to the Product, as amended in accordance with the terms of Article 8 of this Agreement.

 

1.33 “Term” shall have the meaning set forth in Section 15.1.

 

1.34 “Territory” means the United States of America and any other country which the parties agree in writing to add to this definition of Territory in an amendment to this Agreement.

 

1.35 “Unit Pricing” shall have the meaning set forth in Section 7.1.

 

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1.36 “Validation Batches” shall mean each Batch of Product manufactured by Cardinal Health which is necessary to support the validation portion of Targanta’s NDA or ANDA submission to the FDA.

ARTICLE 2

VALIDATION, PROCESSING & RELATED SERVICES

2.1 Validation Services . Cardinal Health shall perform the qualification, validation and stability services described in Exhibit A and Exhibit B of this Agreement for the prices specified therein.

Supply and Purchase of Product . During the Term, Cardinal Health shall Process the Products in accordance with the Specifications, the Applicable Laws and the terms and conditions of this Agreement. Targanta shall purchase the Product from Cardinal Health in accordance with the terms and conditions of this Agreement.

2.3 Other Related Services . Cardinal Health shall provide other services upon terms and conditions agreed to by the parties in writing from time to time.

ARTICLE 3

MATERIALS

3.1 API . Targanta shall supply to Cardinal Health for Processing, at Targanta’s sole cost, the API and applicable reference standards in quantities sufficient to meet Targanta’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Cardinal Health for Processing, Targanta shall provide to Cardinal Health a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Targanta shall supply the API, reference standards, and Certificate of Analysis FOB the Facility no later than [*] before the scheduled Processing Date upon which such API will be used by Cardinal Health. Upon receipt of the API, Cardinal Health shall conduct identification testing of the API. Cardinal Health will bear risk of loss of the API while the API is held at Cardinal Health’s Facility, subject to the limitations of liability in Section 16.1. Cardinal Health shall use the API solely and exclusively for Processing under this Agreement.

3.2 Raw Materials . Cardinal Health shall be responsible for procuring, inspecting and releasing adequate Raw Materials as necessary to meet the Firm Commitment, unless otherwise agreed to by the parties in writing. If Targanta requires a specific supplier for any Raw Material, Targanta shall be responsible for the timeliness, quantity and quality of supply of such Raw Materials. Targanta will be responsible for all costs associated with qualification of a new supplier of a Raw Material not previously qualified by Cardinal Health. Unless a particular Raw Material can be replaced with the same raw material from another supplier, Cardinal Health shall not be liable for any delay in delivery of Product if (i) Cardinal Health is unable to obtain, in a timely manner, a particular Raw Material necessary to Process the Product, and (ii) Cardinal Health placed orders for such Raw Materials promptly following receipt of Targanta’s Firm Commitment.

 


*Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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3.3 Artwork and Packaging . Targanta shall provide or approved, prior to the procurement of applicable components, all artwork, advertising and packaging information necessary to Process the Product. Such artwork, advertising and packaging information is and shall remain the exclusive property of Targanta, and Targanta shall be solely responsible for the content thereof. Such artwork, advertising and packaging information or any reproduction thereof may not be used by Cardinal Health following the termination of this Agreement, or during the Term of this Agreement in any manner other than solely for the purpose of performing its obligations hereunder.

3.4 Reimbursement for Materials . In the event of (i) a Specification change for any reason, (ii) termination or expiration of this Agreement; or (iii) obsolescence of any Raw Materials, Targanta shall bear the cost of any unused Raw Materials, provided that Cardinal Health purchased such Raw Materials in quantities consistent with the [*] of Targanta’s Rolling Forecast and any minimum purchase obligations required by the Raw Material supplier. If materials were purchased by Cardinal Health in quantities exceeding the [*] of Targanta’s Rolling Forecast and such materials become obsolete, then Cardinal Health shall bear the cost of the unused Raw Materials.

ARTICLE 4

[*], PURCHASE ORDERS & FORECASTS

4.1 [*]. Beginning in [*] and during each [*] of the Term of this agreement, the [*], provided, however that the parties agree that [*] of Product for delivery during the [*]. For clarity, Product [*] shall not satisfy the [*]. If [*], within [*] after the end of such [*], [*] the difference between (i) the [*] if the [*] had been fulfilled for the Product and (ii) the [*] for the Product during the just-concluded [*]. Cardinal Health shall notify Targanta of acceptance of the [*] of receipt. Cardinal Health shall not be obligated to supply more than [*] in any [*].

4.2 Forecasts and Purchase Orders . On or before the [*], beginning [*] the anticipated Commencement Date, Targanta shall furnish to Cardinal Health a [*] rolling forecast of the quantities of Product that Targanta intends to order from Cardinal Health during such period (“Rolling Forecast”). The [*] of such Rolling Forecast shall constitute a binding order for the quantities of Product specified therein (“Firm Commitment”) and the following [*] of the Rolling Forecast shall be non-binding, good faith estimates. Targanta shall provide a binding, non-cancelable purchase order for the Firm Commitment portion of the Rolling Forecast at the same time that it submits the Rolling Forecast. Such purchase order shall specify the actual number of Batches to be Processed, the approximate number of Dosage Containers in each Batch, and the requested delivery dates for each Batch. Cardinal Health shall notify Targanta of acceptance of the Rolling Forecast and Purchase Order or of any amended terms within [*] of receipt. In the event of a conflict between the terms of any Rolling Forecast or Purchase Order and this Agreement, this Agreement shall control. Notwithstanding the foregoing, Cardinal Health shall use [*] to supply Targanta with quantities of Product which are in excess of the quantities specified in the Firm Commitment.

 


*Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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4.4 Cancellation of Purchase Orders Due to Failure to Ship API . In the event Targanta refuses or fails to make scheduled deliveries of the API as required by Section 3.1 of this Agreement, Targanta shall notify Cardinal Health when it expects to make such delivery. If Cardinal Health does not receive such API at least [*] prior to the expected Processing Date, Cardinal Health may cancel all, or any part of, the Purchase Order relative to the API that was not shipped as scheduled, and Cardinal Health shall have no further obligations or liability with respect to this particular Purchase Order for material which API was not shipped on time to meet production schedule requirements.

4.5 Unplanned Delay or Elimination of Processing . Cardinal Health shall use [*] to meet the Purchase Orders where API shipment has been delayed, subject to the terms and conditions of this Agreement in Section 4.4. Cardinal Health shall provide Targanta with [*] if Cardinal Health determines that any Processing will be delayed or eliminated for any reason. This Section 4.5 for unplanned delay or elimination of Processing is specifically tied to failure of Targanta to ship required API on time.

ARTICLE 5

TESTING; SAMPLES; RELEASE

5.1 Sample; Testing; Acceptance . Targanta shall notify Cardinal Health within [*] following delivery of Product to Targanta if Targanta has determined that such Product does not conform to Specifications and shall provide Cardinal Health a sample of such non-conforming Product. If Cardinal Health agrees that the Batch is non-conforming, Cardinal Health shall, at Targanta’s option, re-perform the services in accordance with this Article, or credit any payments made by Targanta for such Product. If Cardinal Health does not agree with Targanta’s determination that such Product fails to meet the Specifications, then after reasonable efforts to resolve the disagreement, either party may submit a sample of such Product to a mutually agreed upon independent third party laboratory to determine whether the Product meets the Specifications. The independent party’s results shall be final and binding. Unless otherwise agreed to by the parties in writing, the costs associated with such testing and review shall be borne by the non-prevailing party.

5.2 Replacement of Defective Product . In accordance with the terms set forth in this Agreement, Cardinal Health shall replace, [*], all Product that does not comply with the Specifications (“Defective Product”). THE OBLIGATION OF CARDINAL HEALTH TO (I) REPLACE DEFECTIVE PRODUCT IN ACCORDANCE WITH THE SPECIFICATIONS OR CREDIT TARGANTA FOR SUCH DEFECTIVE PRODUCT AND (II) REIMBURSE TARGANTA FOR [*] THE SUPPLIED MATERIALS (INCLUDING WITHOUT LIMITATION [*]) RENDERED UNUSEABLE DUE TO USE IN SUCH DEFECTIVE PRODUCT ([*]) SHALL BE TARGANTA’S [*] UNDER THIS AGREEMENT FOR DEFECTIVE PRODUCT AND IS [*].

5.3 Supply of Material for Replacement Product . In the event Cardinal Health is required to replace Product pursuant to Section 5.2, above, Targanta shall supply Cardinal Health with sufficient quantities of the API [*]. Material will be supplied to Cardinal Health by Targanta as necessary for Cardinal Health to complete such replacement. Cardinal Health will use [*] to meet scheduling requirements for Replacement Product.

 


*Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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ARTICLE 6

DELIVERY

6.1 Delivery . Cardinal Health shall segregate and store all Product until acceptance as set forth in Section 5.1 above. Cardinal Health shall tender the Product for delivery, [*]. [*] shall be responsible for all costs and risk of loss associated with shipment of the Product. [*] shall designate acceptable carriers to ship the Product and then designate the priority of such qualified carriers [*].

6.2 Failure to Take Delivery . If Targanta fails to take delivery on any scheduled delivery date, Targanta shall be invoiced [*] for the stored Product [*]. For each such batch of undelivered Product, Targanta agrees that: (i) Targanta has made a fixed commitment to purchase such Product, (ii) risk of ownership for such Product passes to Targanta, (iii) such Product shall be on a bill and hold basis for legitimate business purposes, (iv) if no delivery date is determined at the time of billing, Cardinal Health shall have the right to ship the Product to Targanta [*] after billing, and (v) Targanta will be responsible for any decrease in market value of such Product that relates to factors and circumstances outside of Cardinal Health’s control. Within [*] following a written request from Cardinal Health, Targanta shall provide Cardinal Health with a letter confirming items (i) through (v) of this Section for each Batch of undelivered Product.

ARTICLE 7

PRICING AND PAYMENT

7.1 Pricing . Targanta shall pay to Cardinal Health the unit pricing set forth on Exhibit B (“Unit Pricing”) for all Product. In addition, Targanta shall pay Cardinal Health for certain regulatory support services as set forth on Exhibit B . In the event Targanta requests any other services, Cardinal Health shall provide a written quote of the fee for such additional services and Targanta shall advise Cardinal Health whether it wishes to have such additional services performed by Cardinal Health.

7.2 Price Increase . Cardinal Health may implement an increase in the Unit Price [*] following completion of the [*] in accordance with the total percentage change in the Producer Price Index, Pharmaceutical Preparations (Series ID PCU325412325412) (“PPI”) as published by the U.S. Department of Labor, Bureau of Labor Statistics over the [*] preceding the date of such price increase, provided , however , that the amount of such price increase shall be [*] in any [*] regardless of the change in the PPI. Notwithstanding the foregoing, if Cardinal Health’s cost for any Raw Material increases by more than [*], Cardinal Health shall be entitled to increase the Unit Price by [*]. In such event, Cardinal Health shall provide [*] of the increased cost of Raw Materials.

7.3 Taxes; Duty. All taxes, duties and other amounts assessed on the Raw Materials, API or the Product by governmental entities prior to or upon sale to Targanta are the responsibility of Targanta, and Targanta shall reimburse Cardinal Health for any such taxes or duties paid by Cardinal Health.

 


*Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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7.4 Product Approval . Notwithstanding the terms set forth above, Targanta shall use [*] to expedite and obtain all regulatory approvals necessary for Cardinal Health to commence production at the Facility (“Regulatory Approvals”).

7.5 Payment Terms . Cardinal Health shall invoice Targanta for all Product as provided in Section 5.1, and payment for such invoices shall be due [*] after invoice receipt. In the event payment made to Cardinal Health after [*] (payment made [*] after invoice receipt and sent to Cardinal Health) then such unpaid amount shall accrue interest at the rate of [*] until paid in full.

ARTICLE 8

CHANGES TO SPECIFICATIONS

All Specifications and any changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. No change in the Specifications shall be implemented by Cardinal Health, whether requested by Targanta or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in fees associated with such change. Cardinal Health shall use [*] to respond within [*] to any request made by Targanta for a change in the Specifications, and both parties shall use [*] to agree to the terms of such change within [*] of request for change. As soon as possible after a request is made for any change in Specifications, Cardinal Health shall notify Targanta of the fees associated with such change and shall provide such supporting documentation as Targanta may reasonably require. Targanta shall pay all fees associated with such agreed upon changes. The parties shall share in any cost savings that result from a change in Specifications that improves the efficiency of the manufacturing process and that requires submission of at least a CBE30 filing with the FDA.

ARTICLE 9

RECORDS; REGULATORY MATTERS

9.1 Batch Records and Data . Cardinal Health shall provide Targanta with one properly completed copy of the Batch records prepared for each Batch of Product released by Cardinal Health’s Quality Assurance group within [*]. Cardinal Health will provide additional copies at Targanta’s expense.

9.2 Recordkeeping . Cardinal Health shall maintain true and accurate books, records, test and laboratory data, reports and all other information relating to Processing under this Agreement, including all information required to be maintained by all Applicable Laws. Such information shall be maintained in forms, notebooks and records for a period of at least [*] from the relevant finished Product expiration date or longer if required under Applicable Laws.

9.3 Regulatory Compliance . Targanta shall be solely responsible for all permits and licenses required by any regulatory agency with respect to the Product and the Processing under this Agreement, including any product licenses, applications and amendments in connection therewith. Cardinal Health will be responsible to maintain all permits and licenses required by any Regulatory Authority with respect to the Facility. During the Term, Cardinal Health will assist Targanta with all regulatory matters relating to Processing under this Agreement, at Targanta’s request and at Targanta’s expense. Each party intends and commits to cooperate to satisfy all Applicable Laws relating to Processing under this Agreement.

 


*Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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9.4 Quality Audits . During the term of this Agreement, up to [*] duly-authorized employees, agents and representatives of Targanta for up to [*] shall be granted access to the Facility [*] upon at least [*] prior written notice and at reasonable times during regular business hours for the purpose of inspecting and verifying that Cardinal Health is complying with cGMPs, the Specifications and the Product master batch record. Targanta shall have the right to perform additional for cause audits in the case of a critical deviation or unexpected event impacting product quality. For purposes of this Section 9.4, duly-authorized agents and representatives shall be required to sign Cardinal Health’s standard Confidential Disclosure Agreement prior to being allowed access to Cardinal Health’s Facilities.

9.5 Inspection of Processing . Targanta may base up to [*] representatives at the Facilities to observe the Processing provided that Targanta provides Cardinal Health at least [*] advance written notice of the attendance of such Targanta representatives. Targanta shall indemnify and hold harmless Cardinal Health for any action or activity of such representatives while on Cardinal Health’s premises.

9.6 Governmental Inspections and Requests . Cardinal Health shall immediately (within [*]) advise Targanta if an authorized agent of any Regulatory Authority visits the Facility concerning the Processing of the Product. Targanta may, upon mutual agreement, be present at the Facility for any Regulatory Authority visit concerning the Processing or the Product. Upon request, Cardinal Health shall furnish to Targanta a copy of the relevant portions of any report by such Regulatory Authority, if any, within [*] of Cardinal Health’s receipt of such report. Further, upon receipt of a Regulatory Authority request to inspect the Facilities or audit Cardinal Health’s books and records with respect to Processing under this Agreement, Cardinal Health shall immediately notify Targanta, and shall provide Targanta with a copy of any written document received from such Regulatory Authority relating to the Product before the audit and within [*] following receipt of any regulatory report. Targanta may send up to [*] representatives to the Facility during any Regulatory inspection relating specifically to the Product. Cardinal will not necessarily allow Targanta into the inspection process, but will provide daily updates to Targanta representatives and opportunity for input during the process to the extent relevant to the Product.

9.7 Recall . In the event Cardinal Health believes a recall, field alert, Product withdrawal or field correction may be necessary with respect to any Product provided under this Agreement, Cardinal Health shall immediately notify Targanta in writing. Cardinal Health will not act to initiate a recall, field alert, Product withdrawal or field correction without the express prior written approval of Targanta, unless otherwise required by Applicable Laws or upon the advice of legal counsel. In the event Targanta believes a recall, field alert, Product withdrawal or field correction may be necessary with respect to any Product provided under this Agreement, Targanta shall immediately notify Cardinal Health in writing and Cardinal Health shall use commercially reasonable efforts to provide all necessary cooperation and assistance to Targanta. Targanta shall bear the cost of, and shall reimburse Cardinal Health for expenses incurred in connection with, any recall, field alert, Product withdrawal or field correction related to the Product except to the extent such recall, field alert, Product withdrawal or field correction is

 


*Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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caused by Cardinal Health’s breach of its obligations under this Agreement or Applicable Laws or its gross negligence or willful misconduct, in which case, such cost shall be shared by Cardinal Health and Targanta, according to fair responsibility for the recall, field alert, Product withdrawal or field correction. For purposes hereof, such cost shall be limited to reasonable, actual and documented administrative costs incurred by Targanta for such recall, withdrawal or correction, and replacement of the Defective Product to be recalled, in accordance with Article 5.

9.8 Quality Agreements . Attached to this Agreement as Exhibit C is a copy of the Quality Agreement executed by the parties relating to the Product (“Quality Agreement”). The Quality Agreement shall in no way determine liability or financial responsibility of the parties for the responsibilities set forth therein. In the event of a conflict between the terms of this Agreement and the Quality Agreement, this Agreement shall control except with respect to matters relating to compliance with GMPs and related regulations, in which case, the Quality Agreement will control.

ARTICLE 10

REPRESENTATIONS AND WARRANTIES

10.1 Cardinal Health . Cardinal Health represents and warrants to Targanta that:

A. At the time of delivery of the Product as provided in Section 6.1, such Product will conform to and will have been Processed in conformance with the Product Specifications and Applicable Laws.

B. All Product prepared for or delivered to Targanta by Cardinal Health will be produced, held, used, and/or disposed of by Cardinal Health in accordance with all Applicable Laws.

C. Cardinal Health shall not use any materials provided by or prepared for Targanta for any purpose other than that explicitly set forth in this Agreement.

D. Cardinal Health will comply with all Applicable Laws applicable to Cardinal Health’s performance under this Agreement.

10.2 Targanta . Targanta represents and warrants to Cardinal Health that:

A. The Targanta-Supplied Materials will comply with all applicable Specifications, will have been produced in compliance with the Applicable Laws;

B. All artwork and the content thereof provided to Cardinal Health shall comply with all Applicable Laws;

C. It has provided all safe handling instructions, health and environmental information and material safety data sheets applicable to the Product or to and any Targanta-Supplied Materials, except as disclosed to Cardinal Health in writing by Targanta in sufficient time for review and training by Cardinal Health prior to delivery;

 

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D. All Product delivered to Targanta by Cardinal Health will be held, used and/or disposed of by Targanta in accordance with all Applicable Laws; and

E. Targanta will comply with all Applicable Laws applicable to Targanta’s performance under this Agreement and its use of any materials or Products provided by Cardinal Health under this Agreement.

F. Targanta will not release the Product if the batch record for a particular Batch of Product indicates that the Product does not comply with the Specifications or Applicable Laws.

G. Prior to releasing any Batch of Product, Targanta will review all Product specific validation records and confirm that the Product has been validated in compliance with Applicable Laws.

10.3 Mutual . Each party hereby represents and warrants to the other party that:

A. Existence and Power . Such party (1) is duly organized, validly existing and in good standing under the laws of the state in which it is organized, (2) has the 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 (3) is in compliance with all requirements of Applicable Laws, except to the extent that any noncompliance would not materially adversely affect such party’s ability to perform its obligations under the Agreement;

B. Authorization and Enforcement of Obligations . Such party (1) has the power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder and (2) has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder.

C. Execution and Delivery . This Agreement has been duly executed and delivered on behalf of such party, and constitutes a legal, valid, binding obligation, enforceable against such party in accordance with its terms;

D. No Consents . All necessary consents, approvals and authorizations of all Regulatory Authorities and other persons required to be obtained by such party in connection with the Agreement have been obtained; and

E. No Conflict . The execution and delivery of this Agreement and the performance of such party’s obligations hereunder (1) do not conflict with or violate any requirement of Applicable Laws; and (2) do not materially conflict with, or constitute a material default or require any consent under, any contractual obligation of such party.

 

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10.4 Limitations . THE REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS ARTICLE 10 ARE THE SOLE AND EXCLUSIVE REPRESENTATIONS AND WARRANTIES MADE BY EACH PARTY TO THE OTHER AND NEITHER PARTY MAKES ANY OTHER REPRESENTATIONS, WARRANTIES OR GUARANTEES OF ANY KIND WHATSOEVER, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.

ARTICLE 11

CONFIDENTIAL INFORMATION

11.1 Mutual Obligation . Cardinal Health and Targanta agree that they will not disclose the other party’s Confidential Information (defined below) to any third party without the prior written consent of the other party except as required by law, regulation or court or administrative order; provided, however, that prior to making any such legally required disclosure, the party making such disclosure shall give the other party as much prior notice of the requirement for and contents of such disclosure as is practicable under the circumstances. Notwithstanding the foregoing, each party may disclose the other party’s Confidential Information to any of its Affiliates that (A) need to know such Confidential Information for the purpose of performing under this Agreement, (B) are advised of the contents of this Article, and (C) agree to be bound by the terms of this Article.

11.2 Definition . As used in this Agreement, the term “Confidential Information” includes all such information furnished by Cardinal Health or Targanta, or any of their respective representatives or Affiliates, to the other or its representatives or Affiliates, whether furnished before, on or after the date of this Agreement and furnished in any form, including but not limited to written, verbal, visual, electronic or in any other media or manner. Confidential Information includes all proprietary technologies, know-how, trade secrets, discoveries, inventions and any other Intellectual Property (whether or not patented), analyses, compilations, business or technical information and other materials prepared by either party, or any of their respective representatives, containing or based in whole or in part on any such information furnished by the other party or its representatives. Confidential Information also includes the existence of this Agreement, which may be requested and not unreasonably withheld, and its terms.

11.3 Exclusions . Notwithstanding Section 11.2, Confidential Information does not include information that (A) is or becomes generally available to the public or within the industry to which such information relates other than as a result of a breach of this Agreement, or (B) is already known by the receiving party at the time of disclosure as evidenced by the receiving party’s contemporaneously dated written records, or (C) becomes available to the receiving party on a non-confidential basis from a source that is entitled to disclose it on a non-confidential basis, or (D) was or is independently developed by or for the receiving party without reference to the Confidential Information, as evidenced by the receiving party’s written records.

11.4 No Implied License . The receiving party will obtain no right of any kind or license under any patent application or patent by reason of this Agreement. Except as provided in Article 12, all Confidential Information will remain the sole property of the party disclosing such information or data.

 

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11.5 Return of Confidential Information . Upon termination of this Agreement, the receiving party shall, upon request, promptly return within thirty (30) days all such information, including any copies thereof, and cease its use or, at the request of the disclosing party, shall promptly destroy the same and certify such destruction to the disclosing party; except for a single copy thereof, which may be retained for the sole purpose of determining the scope of the obligations incurred under this Agreement.

11.6 Survival . The obligations of this Article 11 will terminate [*] from the expiration of this Agreement.

ARTICLE 12

INTELLECTUAL PROPERTY

All Cardinal Health Materials, including without limitation, all improvements, developments, derivatives or modifications to the Cardinal Health Materials, shall be owned exclusively by Cardinal Health. All Targanta Materials, including, without limitation, all improvements, developments, derivatives or modifications to the Targanta Materials shall be owned exclusively by Targanta. For purposes hereof, “Cardinal Health Materials” means all Cardinal Health proprietary information, intellectual property, and developments (including, all patents, patent applications, know-how, inventions, designs, concepts, improvements, technical information, manuals, instructions or specifications), owned, licensed or used by Cardinal Health in developing, formulating, manufacturing, filling, processing or packaging of liquid solutions or pharmaceuticals and the packaging equipment, processes or methods of packaging, or any improvements to any of the foregoing, including any container, pouch, vial, ampoule or other form of liquid container developed by Cardinal Health. For purposes hereof, “Targanta Materials” means all proprietary information, intellectual property and developments owned, developed, licensed or used by Targanta relating to the API, including, without limitation, patents, patent applications, know-how, inventions, designs, concepts, improvements, technical information, trademarks or trade names. For purposes of clarity, to the extent that one party contributes to any improvement, development, derivative, or modification to the other party’s Materials, the contributing party shall and hereby does assign its entire right, title and interest in such contribution to the other party.

ARTICLE 13

INDEMNIFICATION

13.1 Indemnification by Cardinal Health . Cardinal Health shall indemnify and hold harmless Targanta, its Affiliates, and their respective directors, officers, employees and agents (“Targanta Indemnitees”) from and against any and all suits, claims, losses, demands, liabilities, damages, costs and expenses (including reasonable attorneys’ fees) in connection with any suit, demand or action by any third party (“Losses”) [*] (A) any breach of its representations, warranties or obligations set forth in this Agreement or (B) any negligence or willful misconduct [*], except to the extent that any of the foregoing [*] negligence, willful misconduct or breach of this Agreement.

 


*Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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13.2 Indemnification by Targanta . Targanta shall indemnify and hold harmless Cardinal Health, its Affiliates, and their respective directors, officers, employees and agents (“Cardinal Health Indemnitees”) from and against all Losses [*] (A) any breach of its representations, warranties or obligations set forth in this Agreement; (B) [*]; (C) Targanta’s exercise of control over the Project to the extent that Targanta’s instructions or directions violate Applicable Law; (D) any actual or alleged infringement or violation of any patent, trade secret, copyright, trademark or other proprietary rights provided [*]; or (F) any negligence or willful misconduct by [*], except to the extent that any of the foregoing [*] negligence, willful misconduct or breach of this Agreement.

13.3 Indemnification Procedures . All indemnification obligations in this Agreement are conditioned upon the party seeking indemnification: (A) promptly notifying the indemnifying party of any claim or liability of which the party seeking indemnification becomes aware (including a copy of any related complaint, summons, notice or other instrument); provided, however, that failure to provide such notice within a reasonable period of time shall not relieve the indemnifying party of any of its obligations hereunder except to the extent the indemnifying party is prejudiced by such failure; (B) cooperating with the indemnifying party in the defense of any such claim or liability (at the indemnifying party’s expense); and (C) not compromising or settling any claim or liability without prior written consent of the indemnifying party.

ARTICLE 14

INSURANCE

14.1 Cardinal Health. Cardinal Health shall, at its own cost and expense, obtain and maintain in full force and effect the following insurance during the term of this Agreement: (i) Commercial General Liability insurance with per-occurrence and general aggregate limits of not less than [*]; (ii) Products and Completed Operations Liability Insurance with per-occurrence and general aggregate limits of not less than [*]; (iii) Workers’ Compensation and Employer’s Liability Insurance with statutory limits for Workers’ Compensation and Employer’s Liability insurance limits of not less than [*]; (iv) Professional Services Errors & Omissions Liability Insurance with per claim and aggregate limits of not less than [*] covering sums that Cardinal Health becomes legally obligated to pay as damages resulting from claims made by Targanta for errors or omissions committed in the conduct of the services outlined in the Agreements. In lieu of insurance, Cardinal Health may self-insure any or a portion of the above required insurance. In the event that any of the required policies of insurance are written on a claims made basis, then such policies shall be maintained during the entire term of this Agreement and for a period of not less than [*] following the termination or expiration of this Agreement. Cardinal Health shall obtain a waiver from any insurance carrier with whom Cardinal Health carries Workers’ Compensation insurance releasing its subrogation rights against Targanta. Targanta shall be an additional insured under the Commercial General Liability insurance policy as respects Targanta’s liability for damages caused in whole or in part by the acts or omissions of Cardinal Health in the performance of manufacturing services this Agreement. Such additional insured status shall end upon the termination or expiration of this Agreement unless the policy is written on a claims made basis when such additional insured status will continue for a period of time Cardinal Health is required to maintain such insurance under the terms of this Agreement. Upon request, Cardinal Health shall furnish to Targanta a certificate of insurance or other evidence of

 


*Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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the required insurance and additional insured status as soon as practicable after the Effective Date and within thirty (30) days after renewal of such policies. Each insurance policy which is required under this Agreement shall be obtained from an insurance carrier with an A.M. Best rating of at least A- VII.

14.2 Targanta Insurance. Targanta shall, at its own cost and expense, obtain and maintain in full force and effect the following insurance during the term of this Agreement: (i) Products and Completed Operations Liability Insurance (including coverage for products used in clinical trials) with per-occurrence and general aggregate limits of not less than [*]; (ii) Workers’ Compensation and Employer’s Liability Insurance with statutory limits for Workers’ Compensation and Employer’s Liability insurance limits of not less than [*]. In the event that any of the required policies of insurance are written on a claims made basis, then such policies shall be maintained during the entire term of this Agreement and for a period of not less than [*] following the termination or expiration of this Agreement. Targanta shall furnish certificates of insurance for all of the above noted policies and required additional insured status to Cardinal Health as soon as practicable after the Effective Date of the Agreement and upon renewal of any such policies. Each insurance policy that is required under this Section shall be obtained from an insurance carrier with an A.M. Best rating of at least A- VII.

ARTICLE 15

TERM AND TERMINATION

15.1 Term . This Agreement shall commence on the Effective Date and shall continue for a period of three (3) Calendar Years, unless earlier terminated under Section 15.2 below (the “Term”).

15.2 Termination by Either Party .

(a) Material Breach . Either party may terminate this Agreement effective upon sixty (60) days prior written notice to the other party, if the other party commits a material breach of this Agreement and fails to cure such breach by the end of such sixty (60) day period; provided, however, that failure to pay amounts due under this Agreement within [*] after such payments are due (as set forth in Section 7.5) shall relieve Cardinal Health from performing any further obligation under this Agreement until all outstanding payments are brought current.

(b) Bankruptcy . Either party may terminate this Agreement effective upon written notice to the other party, if the other party becomes insolvent or admits in writing its inability to pay its debts as they become due, files a petition for bankruptcy, makes an assignment for the benefit of its creditors or has a receiver, trustee or other court officer appointed for its properties or assets.

ARTICLE 16

LIMITATIONS OF LIABILITY

16.1 CARDINAL HEALTH SHALL [*] FOR [*] LOST, DAMAGED OR DESTROYED API OR OTHER TARGANTA-SUPPLIED MATERIALS, [*].

 


*Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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16.2 CARDINAL HEALTH’S TOTAL LIABILITY UNDER THIS AGREEMENT SHALL [*].

16.3 NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL, SPECIAL OR CONSEQUENTIAL (EXCEPT FOR THOSE INDEMNITY OBLIGATIONS UNDER ARTICLE 13 THAT ARE DEFINED AS CONSEQUENTIAL DAMAGES) DAMAGES ARISING OUT OF PERFORMANCE UNDER THIS AGREEMENT, INCLUDING WITHOUT LIMITATION, LOSS OF REVENUES, PROFITS OR DATA, WHETHER IN CONTRACT OR TORT, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

ARTICLE 17

NOTICE

All notices and other communications hereunder shall be in writing and shall be deemed given: (A) when delivered personally to the representatives named if mentioned below; (B) when delivered by facsimile transmission (receipt verified); (C) when received or refused, if mailed by registered or certified mail (return receipt requested), postage prepaid; or (D) when delivered if sent by express courier service, to the parties at the following addresses (or at such other address for a party as shall be specified by like notice; provided, that notices of a change of address shall be effective only upon receipt thereof):

 

To Targanta:    Targanta Therapeutics Corp.
   225 S. East Street
   Indianapolis, IN 46202-4002
   Attention: Vice President, Manufacturing
With a copy to:    Targanta Therapeutics Corp.
   225 S. East Street
   Indianapolis, IN 46202-4002
   Attn: Director, Quality Assurance
To Cardinal Health:    Cardinal Health PTS, L.L.C.
   4401 Alexander Blvd NE
   Albuquerque, NM 87114
   Attn: General Manager

 


*Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

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With a copy to:    Cardinal Health, Inc.
   7000 Cardinal Place
   Dublin, Ohio 43017
   Attn: Associate General Counsel,
   Pharmaceutical Technologies and Services
   Facsimile: (614) 757-5051

ARTICLE 18

MISCELLANEOUS

18.1 Entire Agreement; Amendments . This Agreement, Exhibits, the attachments, Project Plans and any amendments thereto constitute the entire understanding between the parties and supersede any contracts, agreements or understanding (oral or written) of the parties with respect to the subject matter hereof. No term of this Agreement may be amended except upon written agreement of both parties, unless otherwise provided in this Agreement.

18.2 Captions . The captions in this Agreement are for convenience only and are not to be interpreted or construed as a substantive part of this Agreement

18.3 Further Assurances . The parties agree to execute, acknowledge and deliver such further instruments and to take all such other incidental acts as may be reasonably necessary or appropriate to carry out the purpose and intent of this Agreement.

18.4 No Waiver . Failure by either party to insist upon strict compliance with any term of this Agreement in any one or more instances will not be deemed to be a waiver of its rights to insist upon such strict compliance with respect to any subsequent failure.

18.5 Severability . If any term of this Agreement is declared invalid or unenforceable by a court or other body of competent jurisdiction, the remaining terms of this Agreement will continue in full force and effect.

18.6 Independent Contractors . The relationship of the parties is that of independent contractors, and neither party will incur any debts or make any commitments for the other party except to the extent expressly provided in this Agreement. Nothing in this Agreement is intended to create or will be construed as creating between the parties the relationship of joint ventures, co-partners, employer/employee or principal and agent.

18.7 Successors and Assigns . This Agreement will be binding upon and inure to the benefit of the parties, their successors and permitted assigns. Neither party may assign this Agreement, in whole or in part, without the prior written consent of the other party, except that either party may, without the other party’s consent, assign this Agreement to an Affiliate or to a successor to substantially all of the business or assets of the assigning company.

 

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18.8 Governing Law . This Agreement shall be governed by and construed under the laws of the State of Ohio, excluding its conflicts of law provisions. The United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Agreement.

18.9 Alternative Dispute Resolution . If any dispute arises between the parties (“Dispute”), such Dispute shall be presented to the respective presidents or senior executives of Cardinal Health and Targanta for their consideration and resolution. If such parties cannot reach a resolution of the Dispute, then such Dispute shall be resolved by binding alternative dispute resolution in accordance with the then existing commercial arbitration rules of CPR Institute for Dispute Resolution, 366 Madison Avenue, New York, NY 10017. Arbitration shall be conducted in the jurisdiction of the defendant party.

18.10 Prevailing Party . In any dispute resolution proceeding between the parties in connection with this Agreement, the prevailing party will be entitled to its reasonable attorney’s fees and costs in such proceeding.

18.11 Counterparts . This Agreement may be executed in one or more counterparts, each of which will be deemed an original but all of which together will constitute one and the same instrument. Any photocopy, facsimile or electronic reproduction of the executed Agreement shall constitute an original.

18.12 Publicity . Neither party will make any press release or other public disclosure regarding this Agreement or the transactions contemplated hereby without the other party’s express prior written consent, not to be unreasonably withheld, except as required under applicable law or by any governmental agency, in which case the party required to make the press release or public disclosure shall use commercially reasonable efforts to obtain the approval of the other party as to the form, nature and extent of the press release or public disclosure prior to issuing the press release or making the public disclosure. Each party shall furnish advance and final copy to the other party per Article 17.

18.13 Setoff . Without limiting Cardinal Health’s rights under law or in equity, Cardinal Health, its Affiliates, or parent, collectively or individually, may exercise a right of set-off against any and all amounts due to Cardinal Health from Targanta. For purposes of this Article, Cardinal Health, its Affiliates, or parent shall be deemed to be a single creditor.

18.14 Survival . The rights and obligations of the parties shall continue under Articles 6 (Confidentiality), 7 (Intellectual Property), 9 (Indemnification), 10 (Limitations of Liability), 11 (Insurance), to the extent expressly stated therein, 13 (Notice), 14 (Miscellaneous) and Section 12.3 (Effect of Termination), notwithstanding expiration or termination of this Agreement.

18.15 Force Majeure . Except as to payments required under this Agreement, neither party shall be liable in damages for, nor shall this Agreement be terminable or cancelable by reason of, any delay or default in such party’s performance hereunder if such default or delay is caused by events beyond such party’s commercially reasonable control including, but not limited to, acts of God, regulation or law or other action or failure to act of any government or agency thereof, war or insurrection, civil commotion, destruction of production facilities or materials by earthquake,

 

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fire, flood or storm, labor disturbances, epidemic, or failure of suppliers, public utilities or common carriers; provided however, that the party seeking relief hereunder shall immediately notify the other party of such cause(s) beyond such party’s reasonable control. The party that may invoke this section shall use all reasonable endeavors to reinstate its ongoing obligations to the other. If the cause(s) shall continue unabated for one hundred eighty (180) days, then both parties shall meet to discuss and negotiate in good faith what modifications to this Agreement should result from this force majeure.

IN WITNESS WHEREOF, the parties have caused their duly authorized representative to execute this Agreement effective as of the date first written above.

 

CARDINAL HEALTH PTS, LLC     TARGANTA THERAPEUTICS Corp.
By:   /s/ Barry Littlejohns     By:   /s/ Mark Leuchtenberger
Name:   Barry Littlejohns     Name:   Mark Leuchtenberger
Its:   Vice President & General Manager     Its:   President and Chief Executive Officer
Date:   March 27, 2007     Date:   March 26, 2007

 

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EXHIBIT A

SPECIFICATIONS

Specifications* for Oritavancin for Injection 100 mg

[*]

 


*Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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EXHIBIT B

UNIT PRICING AND OTHER FEES

[*]

 


*Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

21

Exhibit 10.11

[***] CERTAIN MATERIAL ( INDICATED BY AN ASTERISK ) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT . THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION .

LICENSE AGREEMENT

This LICENSE AGREEMENT (the “Agreement”) is made effective and entered into as of December 23, 2005 (the “Effective Date”), by and between InterMune, Inc. (“Licensee”), a corporation organized and existing under the laws of the State of Delaware, and Eli Lilly and Company (“Lilly”), a corporation organized and existing under the laws of the State of Indiana. Licensee and Lilly are sometimes referred to herein individually as a “Party” and collectively as “Parties.” For certain purposes under this Agreement, InterMune, Inc. is sometimes referred to as “InterMune.”

RECITALS

WHEREAS, Lilly and Licensee entered into an asset purchase and license agreement on September 21, 2001 (the “Prior Agreement”) pursuant to which (i) Lilly sold or licensed to Licensee, and Licensee purchased or licensed from Lilly, certain product inventory, technology and certain rights thereto and regulatory documents owned by Lilly, and (ii) Licensee assumed certain liabilities associated with the rights and assets transferred herein, each in accordance with the terms and conditions set forth in the Prior Agreement; and

WHEREAS, as of the Effective Date, Targanta Therapeutics, Inc. (“Targanta”) and Licensee intend to enter into an Asset Purchase Agreement (“APA”) under which Targanta (i) will purchase all of Licensee’s right, title and interest in and to the Purchased Assets (as defined in the APA), including, without limitation, Licensee’s rights and obligations under this Agreement; and

WHEREAS, as of and after the Effective Date, this Agreement will govern the exclusive license of the Licensed Technology and Licensed Patents from Lilly to Licensee and the related rights and obligations under such license.

NOW, THEREFORE, in consideration of the foregoing, the covenants and premises contained in this Agreement, and other good and valuable consideration, the sufficiency and receipt of which are hereby acknowledged, the Parties hereby agree as follows:

ARTICLE 1

DEFINITIONS

For purposes of this Agreement, the following terms will have the meanings set forth below:

 

1.1 “Affiliate” means, with respect to a Party, any Person (or Persons) directly or indirectly

Controlling, Controlled by, or under common Control with, such Party.


1.2 “Applicable Laws” means all applicable laws, ordinances, rules and regulations of any kind whatsoever of any governmental or regulatory authority, including, without limitation, all laws, ordinances, rules and regulations promulgated by the FDA.

 

1.3 “Application for Marketing Authorization” means, with respect to Product, (i) in the United States, a New Drug Application filed with the FDA pursuant to 21 U.S.C. Section 357 and 21 C.F.R. Section 314 (“NDA”), and (ii) in any country other than the United States, an application or set of applications for marketing approval comparable to an NDA necessary to make and sell Product commercially in such country.

 

1.4 “Calendar Quarter” means the three month period ending on March 31, June 30, September 30 or December 31.

 

1.5

“Calendar Year” means the twelve (12) month period ending on December 31 st .

 

1.6 “Closing Date” shall have the meaning set forth in the Prior Agreement.

 

1.7 “Compound” means any compound claimed in a Licensed Patent.

 

1.8 “Confidential Information” means information received (whether disclosed in writing, machine readable form, orally or by observation) by one Party (the “Receiving Party”) from the other Party (the “Disclosing Party”) that the Receiving Party: (i) has a reasonable basis to believe is confidential to the Disclosing Party, (ii) is indicated in writing by the Disclosing Party to be confidential, or (iii) is information that the Receiving Party received relating to manufacture of Compound or Product, including but not limited to, manufacturing know-how, unless in each case such information:

(a) was known to the Receiving Party or to the public prior to the Disclosing Party’s disclosure, as demonstrated by contemporaneous written records;

(b) became known to the public, after the Disclosing Party’s disclosure hereunder, other than through a breach of the confidentiality provisions of this Agreement by the Receiving Party or any Person to whom such Receiving Party disclosed such information;

(c) was disclosed to the Receiving Party by a Person having a legal right to disclose, without any restrictions, such information or data; or

(d) was developed by the Receiving Party independent of the Disclosing Party’s Confidential Information, as demonstrated by contemporaneous written records.

 

1.9 “Control,” “Controlling,” “Controlled By ” or “Under Common Control With” means the direct or indirect ability or power to direct or cause the direction of management policies of a Person or otherwise direct the affairs of such Person, whether through ownership of equity, voting securities, beneficial interest, by contract or otherwise.

 

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1.10 “Damages” means any and all costs, losses, claims, demands for payment, threatened government enforcement actions, liabilities, fines, penalties, expenses, court costs and reasonable fees and disbursements of counsel, consultants and expert witnesses incurred by a Party hereto or its Affiliates (including interest which may be imposed in connection therewith).

 

1.11 “Data Exclusivity Period” means, with respect to a country, the period of time (if any) beginning on the date of the first Regulatory Approval by the FDA (or, in countries other than the United States, an equivalent regulatory agency) during which the FDA (or, if applicable, such equivalent regulatory agency) prohibits reference, without the consent of the owner of an Application for Marketing Authorization or Regulatory Approval package, to the clinical and other data that relates to the Product and that is contained in such Application for Marketing Approval or Regulatory Approval package and that is not published or publicly available outside of such Application or Regulatory Approval package.

 

1.12 “European Union” or “EU” means Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxembourg, The Netherlands, Norway, Portugal, Spain, Sweden, the United Kingdom, Switzerland and those additional countries that hereafter become members (whether voting or nonvoting) or are allowed to participate in the European Union.

 

1.13 “FDA” means the United States Food and Drug Administration, any comparable agency in any Foreign Jurisdiction, and any successor agency or entity to any of the foregoing that may be established hereafter.

 

1.14 “Field” means [***].

 

1.15 “Foreign Jurisdiction” means any jurisdiction other than the United States.

 

1.16 “Indication” means Regulatory Approval of, approval by the FDA of a submission made by Licensee under 21 CFR §99.201, or Licensee’s sales and promotion of Product which leads to the treatment of additional diseases [***]. Such additional Indications may include, but not be limited to, [***].

 

1.17 “Initial Product” means a form of Product that had been used by Lilly through the Closing Date, i.e. , oritavancin, which Lilly and Licensee contemplated as of the Closing Date would be the form of Product to be first commercialized by InterMune.

 

1.18 “Licensee Technology” means any inventions, ideas, conceptions or reductions-to-practice, patentable or not, information, works and/or data that are generated, identified, discovered, created and/or made by Licensee, its employees or a Third Person contracted by or otherwise controlled by Licensee [***] and [***].

*** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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1.19 “Licensed Patents” means those United States and foreign patent applications (including provisional applications) and patents listed in Exhibit A attached hereto and all patents and patent applications relating to the [***]; and:

(a) all divisions and continuations of these applications, all patents issuing from such applications, divisions and continuations, and any reissues, reexaminations and extensions of all such patents; and

(b) any continuations-in-part, any divisions and continuations of these continuations-in-part, any patents issuing from such continuations-in-part, divisions and continuations, and any reissues, reexaminations and extensions of all such patents, in each case to the extent that they contain one or more claims directed to the invention or inventions disclosed in the patent applications and patents listed in Exhibit A .

The Licensed Patents will not include any subject matter described or disclosed in subsection (b), above, to the extent such subject matter [***], above, which was filed on or before the Effective Date.

 

1.20 “Licensed Technology” means all tangible or intangible know-how, trade secrets, inventions (whether or not patentable), data, analytical reference materials and methods and all confidential or proprietary chemical substances, assays and technical information which has been developed, created, made, used or acquired by Lilly on or before the Effective Date, to the extent such technology is reasonably necessary, useful for or used in connection with the use or manufacture of the Compound or Product; provided, however, that Licensed Technology will exclude any and all subject matter described or claimed in Licensed Patents.

 

1.21 “Major Market” means [***].

 

1.22 “Net Sales” means, with respect to the Product, the gross amount invoiced by a Permitted Seller of the Product, less:

(a) [***],

(b) [***], and

(c) [***].

Such amounts will be determined from books and records maintained in accordance with GAAP, consistently applied. In determining Net Sales of Product made by Licensee in a Foreign Jurisdiction, Licensee’s then current standard procedures and methodology, including Licensee’s then current exchange rate methodology of foreign currency sales


*** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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into United States Dollars, a copy of which is attached hereto as Schedule 1.22 , will be consistently applied. No deductions will be made for [***], whether they are [***] or [***] by the Permitted Seller.

 

1.23 “Permitted Seller” means Licensee and its Affiliates and any assignee, licensee or sublicensee having the right to sell Product hereunder.

 

1.24 “Person” means a natural person, a corporation, a partnership, a trust, a joint venture, a limited liability company, any governmental authority or any other organization.

 

1.25 “Product” means any final form pharmaceutical composition or preparation, in any dosage strength or size, containing Compound as an active pharmaceutical ingredient that may, pursuant to Applicable Laws, be manufactured, marketed and sold upon Regulatory Approval or otherwise, together with all expansions, improvements and modifications thereon, and which, but for the license granted herein, the manufacture, use, sale, offer for sale or importation of which in the Territory would infringe or contribute to the infringement of a Valid Claim under the Licensed Patents. Notwithstanding the foregoing, any references in this Agreement to “Product manufacturing” or the “manufacture” or “manufacturing” of Product means Product that was manufactured for use in clinical trials and not for commercial use.

 

1.26 “Regulatory Approval” means (i) in the United States, approval by the FDA of an Application for Marketing Authorization and satisfaction of any related applicable FDA registration and notification requirements (if any) and (ii) in a Foreign Jurisdiction, approval by regulatory authorities having jurisdiction over such country of a single Application or set of Applications for Marketing Authorization; provided, however, that with respect to Japan only, Regulatory Approval means the above-described regulatory approval and approval by Japan’s pricing authorities.

 

1.27 “Representatives” of a Party means: (i) that Party’s agents, contractors, employees, officers, directors, consultants and advisors, (ii) its Affiliates, and (iii) the agents, contractors, employees, officers, directors, consultants and advisors of its Affiliates.

 

1.28 “Royalty Term” means, with respect to each country in which the Product is sold:

(a) if no Valid Claim exists in such country, [***] from the date of first commercial sale of Product in such country, or if a Valid Claim exists in such country, the period of time from the Effective Date until the expiration in such country of the last-to-expire Licensed Patent with a Valid Claim; and

(b) if there is a [***] in such country for Product after the expiration of the applicable time period in (a), above, the period of time until [***] in such country.

 

1.29 “Territory” means the entire world.

 

1.30 “Third Person” means a Person that is not a Party to this Agreement or an Affiliate of a Party to this Agreement.

*** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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1.31 “Valid Claim” means a claim of an issued and unexpired Licensed Patent in a country which: (i) but for this Agreement, would preclude the sale or other disposition of Product by Licensee or another Permitted Seller, (ii) has not been revoked or held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and (iii) has not been abandoned, disclaimed or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise.

ARTICLE 2

PRIOR AGREEMENT

 

2.1 Prior Agreement Novated. The terms and conditions of the Prior Agreement related to the sale by Lilly to InterMune of certain documents, rights, technology and Product Inventory as defined in the Prior Agreement, and InterMune’s payment at the Closing Date of the Prior Agreement have been fully performed and satisfied. This Agreement is a novation of the Prior Agreement and, except as expressly set forth herein, supersedes the Prior Agreement in its entirety. Lilly and Licensee hereby expressly release and forever discharge and covenant not to sue the other party and its successor, assigns and predecessors, as well as all its directors, officers, employees, equity holders, representatives, agents and attorneys, from and for any and all debts, actions, accounts, suits, covenants, agreements, demands, claims, damages, causes of action and liabilities, whether liquidated or non-liquidated, fixed or contingent, matured or unmatured, known or unknown, related to the Prior Agreement, that such party asserted, or could have asserted, against the other party by reason of any acts or omissions of the first party related to the Prior Agreement prior to the date hereof, including, without limitation, payment by InterMune to Lilly of the Ten Million Dollar ($10,000,000) milestone due under Section 2.2 of the Prior Agreement “upon completion of Phase III Clinical Trials necessary to support first submission of NDA with FDA for Regulatory Approval,” except for Damages (as defined in the Prior Agreement) to the extent caused by or arising out of or in connection with (i) any claim for any breach of this Agreement; (ii) any breach by the Receiving Party of the requirements of the Prior Agreement with respect to Confidential Information (as defined in the Prior Agreement); (iii) any claim to the extent caused by or arising out of or in connection with the Assumed Liabilities (as defined in the Prior Agreement) prior to the Effective Date and (iv) obligations of indemnification under Article 11 of the Prior Agreement to the extent caused by or arising out of or in connection with such obligations prior to the Effective Date (items (ii) through (iv) the “Prior Claims”).

 

2.2 Consent to Assignment. Pursuant to Section 12.1 of the Prior Agreement and this Agreement, by executing this Agreement Lilly hereby ratifies this Agreement and indicates its approval of the assignment to Targanta of all of Licensee’s rights and obligations under this Agreement (other than the Prior Claims). Contingent upon the consummation of the proposed transaction with Targanta, InterMune will retain only the obligations associated with the Prior Claims and will have no other rights or obligations under this Agreement, and all such other rights and obligations under this Agreement

 

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shall be assumed by Targanta. For clarity, Targanta will not assume any of InterMune’s obligations under the Prior Agreement which are not expressly set forth herein or in the APA. For the avoidance of doubt, Lilly shall have no responsibility for Assumed Liabilities or for any Damages that are covered by indemnification obligations from and after the Closing Date of the Prior Agreement and such Assumed Liabilities and Damages are the responsibility and liability of InterMune if they are based on facts or circumstances first accruing from the Closing Date until the Effective Date and are the responsibility and liability of Targanta if they are based on facts or circumstances first accruing after the Effective Date. Similarly, InterMune shall have no responsibility for Excluded Liabilities (as defined in the Prior Agreement) or for any Damages that are covered by indemnification obligations prior to the Effective Date, and Targanta shall have no responsibility for Excluded Liabilities or for any Damages that that are covered by indemnification obligations subsequent to the Effective Date, and such Excluded Liabilities and Damages shall remain the responsibility and liability of Lilly under this Agreement and the Prior Agreement.

 

2.3 Conflict with Prior Agreement. To the extent that any term or provision of this Agreement conflicts with the Prior Agreement, the terms of this Agreement shall control.

ARTICLE 3

CONSIDERATION

In consideration of the licenses granted by Lilly to Licensee under the Licensed Patents and the Licensed Technology as set forth in this Agreement, Licensee will pay the following amounts to Lilly:

 

3.1 Milestone Payments for Product . Within thirty (30) days of Licensee and/or its Permitted Sellers achieving a milestone event listed below following the Effective Date with respect to the Product, Licensee will pay the below-specified non-creditable and non-refundable fee to Lilly by Federal Reserve electronic wire transfer in immediately available funds to an account designated by Lilly.

 

Milestone Event

  

Payment

Regulatory Approval for first Indication

  

Ten Million Dollars ($10,000,000)

 

This milestone payment is intended for the first Indication that receives Regulatory Approval.

Regulatory Approval for second Indication

  

Ten Million Dollars ($10,000,000)

 

This milestone payment is intended for the second Indication that receives Regulatory Approval

First Calendar Year in which Net Sales exceed Two Hundred and Ten Million Dollars ($210,000,000)    Fifteen Million Dollars ($15,000,000)

 

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3.2 Royalty Payment Calculation . Licensee will pay Lilly a royalty (the “Royalty Payment”) during the Royalty Term based upon Net Sales of Product during each Calendar Year. Except as set forth in Section 3.3 below, the following royalty percentages will apply:

 

Net Sales of Product During a

Calendar Year

  

Royalty Percentage on Net Sales of

Product in Jurisdictions in Which a

Valid Claim Exists

$0 to $200,000,000    10%
$200,000,000 - $400,000,000    12%
More than $400,000,000    18%

 

3.3 Royalty Payment.

(a) Payments . Licensee will pay to Lilly the Royalty Payment within [***] of the end of each Calendar Quarter, without regard to whether any Permitted Seller’s customer has actually paid Licensee. For purposes of this Section 3.4, a Net Sale of Product will be deemed to have been made as of the date of shipment of the Product to the Permitted Seller’s customer, without regard to whether its customer has actually paid Licensee. All payments to Lilly pursuant to this Section 3.4 will be made by Licensee by an electronic funds transfer system designated or approved by Lilly unless otherwise instructed by Lilly.

(b) Payment of Tiered Royalties . In calculating Royalty Payments payable in accordance with Section 3.2 above, Net Sales occurring during a specific Calendar Year will be aggregated at the end of each Calendar Quarter during such year, and the applicable royalty percentage(s) will be applied to that portion of the Net Sales that occurred during the most recently completed Calendar Quarter.

Example : In Calendar Year One, Net Sales by Calendar Quarter in such year were as follows: (i) Calendar Quarter One—$175 million, (ii) Calendar Quarter Two—$200 million, (iii) Calendar Quarter Three—$350 million, and (iv) Calendar Quarter Four—$500 million. Licensee would owe Lilly the following Royalty Payment: (1) Calendar Quarter One—$175 million x 10%, (2) Calendar Quarter Two—$175 million x 12% plus $25 million x 10%, (3) Calendar Quarter Three—$325 million x 18% plus $25 million x 12%, and (4) Calendar Quarter Four—$500 million x 18%.


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3.4 Quarterly Report. Within [***] after the end of each Calendar Quarter, Licensee will furnish Lilly a written report detailing: (i) the Net Sales of Product for the previous Calendar Quarter, broken down by country and between Licensee and any Permitted Sellers, (ii) the Royalty Payment that is due and payable, and (iii) the basis for calculating such Royalty Payment. Licensee will mail such reports to the attention of: [***].

 

3.5 Taxes. If laws or regulations require the withholding of taxes on any Royalty Payment due Lilly, Licensee will deduct such taxes from the Royalty Payment and remit the tax to the proper tax authority. Licensee will provide Lilly with proof of payment within thirty (30) days after payment. Licensee will cooperate fully and promptly in pursuing a refund of such tax, if such refund is appropriate in Lilly’s determination.

 

3.6 Late Payments. Any amounts not paid by Licensee when due under this Agreement and which are not subject to a good faith dispute will be subject to interest from and including the date payment is due through and including the date upon which Lilly has collected the funds in accordance herewith at a rate equal to the lesser of (i) the sum of [***] plus the prime rate of interest quoted in the Money Rates section of the Wall Street Journal , calculated daily on the basis of a three hundred sixty (360) day year, or (ii) the maximum interest rate allowed by law.

 

3.7 No Excuse. Licensee will not be excused from or relieved of its obligations to pay the amounts described in this Article 3 by any claimed or actual event of force majeure, commercial or other impracticability or impossibility, or frustration of essential purpose.

 

3.8 Currency of Payment. All payments to be made under this Agreement will be made in U.S. Dollars.

 

3.9 Financial Audits. Licensee will keep full and accurate books and records relating to the performance required of it under this Agreement. Lilly will have the right, during regular business hours and upon reasonable advance notice, to have such books and records of Licensee audited no more than one (1) time per Calendar Year so as to verify the accuracy of the information previously reported to Lilly. Lilly will, for purposes of such audit, utilize only the services of an independent certified public accounting firm selected by Lilly and approved by Licensee, such approval not to be unreasonably withheld. Such audit may cover the two (2) Calendar Years preceding the date of the request for such audit. Notwithstanding the foregoing, no audit of Licensee pursuant to this Section 2.10 will cover any period of time preceding the Effective Date. Such accountants will keep confidential any information obtained during such audit and will, report to Lilly only their conclusions. The cost of such audit will be borne by Lilly; however, if such audit reveals an underpayment to Lilly of [***] or more, the cost of the audit will be borne by Licensee. Within thirty (30) days after both Parties have received a copy of an audit report, Licensee or Lilly, as appropriate, will compensate the other Party for payment errors or omissions revealed by the audit. Licensee will include in all sublicenses granted in accordance herewith, and any other agreements enabling a Third Person to be a Permitted Seller, an audit provision substantially similar to the foregoing requiring such Permitted Seller to keep full and accurate books and records relating to the

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Product and granting Lilly the right to have an independent public accounting firm audit the accuracy of the information reported by the sublicensee in connection therewith.

 

3.10 Compulsory License. If a Third Person obtains a Compulsory License (as defined below) in a specific country, then Lilly will promptly notify Licensee thereof. If the royalty percentage(s) payable by the grantee of the Compulsory License is less than the royalty percentage(s) applicable in such country as set forth in Sections 3.2, above, then such royalty percentage(s) will be reduced to the royalty percentage(s) under such Compulsory License for so long as sales of Product are made pursuant to the Compulsory License. “Compulsory License” means a compulsory license under the Licensed Patents obtained by a Third Person through the order, decree or grant of a competent governmental authority authorizing such Third Person to manufacture, use, sell, offer for sale or import the Product in a specific country.

ARTICLE 4

LICENSE OF RIGHTS

 

4.1 Grant of License to Licensee under Licensed Patents. Subject to the terms and conditions set forth herein, during the term of this Agreement, Lilly hereby grants to Licensee, and Licensee accepts, under the Licensed Patents, a royalty-bearing, exclusive (even as to Lilly, except as expressly provided in the following sentence) license in the Field, with a right to sublicense, to make, have made, use, offer to sell, sell and import Product in the Territory. Such license is exclusive even as to Lilly except that Lilly hereby retains a right under the Licensed Patents to [***].

 

4.2 Grant of License to Licensee under Licensed Technology. Subject to the terms and conditions set forth herein, during the term of this Agreement, Lilly hereby grants to Licensee, and Licensee accepts, under the Licensed Technology, an exclusive (even as to Lilly) license in the Field, with a right to sublicense, to make, have made, use, offer to sell, sell and import Product in the Territory.

 

4.3 Sublicenses and Business Opportunities. Licensee will notify Lilly of any sublicenses granted and will, subject to applicable confidentiality restrictions, provide Lilly with the material terms of the sublicense agreement. Licensee will remain liable for Royalty Payments as a result of Net Sales made by a sublicensee pursuant to a sublicense or license. If, during the term of this Agreement, (i) Licensee begins negotiations to enter into a commercialization relationship with a Third Person with respect to selling Product in a specific country, or (ii) a Third Person initiates such discussions with Licensee and Licensee is interested in entertaining such discussions (both (i) and (ii) are collectively referred to as a “Business Opportunity”), then Licensee will notify Lilly in writing thereof, with such notice containing reasonable available non-confidential information relevant to the Business Opportunity.

 

4.4 Excluded Assets. Anything herein to the contrary notwithstanding, Licensee will have no right, title or interest in or to the trademarks “ELI LILLY AND COMPANY” and “LILLY” and any variation thereof, and any other rights in or to such names.

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ARTICLE 5

REPRESENTATIONS AND WARRANTIES OF LILLY

 

5.1 Ownership of Intellectual Property. Lilly represents and warrants that (i) either Lilly or an Affiliate of Lilly is the owner of the Licensed Patents and the Licensed Technology which were warranted under the Prior Agreement (collectively, the “Warranted Intellectual Property”), and (ii) Lilly or its Affiliates can and have the right to license the Warranted Intellectual Property to Licensee hereunder without the consent of any Third Person.

 

5.2 Claims Related to Use of Intellectual Property. Lilly represents and warrants that there are no pending or, to Lilly’s knowledge, threatened claims against Lilly asserting that any of the activities of Lilly relating to the Warranted Intellectual Property or the conduct of the activities contemplated herein by the Parties relating to the Warranted Intellectual Property infringes or violates the rights of Third Persons.

 

5.3 Notice to Third Persons. Lilly represents and warrants that Lilly has not given any notice to any Third Persons asserting infringement by such Third Persons upon any of the Warranted Intellectual Property.

 

5.4 Rights Granted to Third Persons. Lilly represents and warrants that Lilly has not executed or granted to any Third Person, directly or indirectly, or entered into any agreement for, any license or other right to make, use, offer to sell, sell or import the Product in the Territory.

 

5.5 Organization and Standing. Lilly represents and warrants that Lilly is a corporation duly organized, validly existing and in good standing under the laws of the State of Indiana.

 

5.6 Power and Authority. Lilly represents and warrants that (i) Lilly has all requisite corporate power and authority to execute, deliver and perform this Agreement and the other agreements and instruments to be executed and delivered by it pursuant hereto and thereto and to consummate the transactions contemplated herein and therein, and (ii) the execution, delivery and performance of this Agreement by Lilly does not, and the consummation of the transactions contemplated hereby will not, violate any provisions of Lilly’s organizational documents, bylaws, any law or regulation applicable to Lilly, or any agreement, mortgage, lease, instrument, order, judgment or decree to which Lilly is a party or by which Lilly is bound.

 

5.7 Corporate Action; Binding Effect. Lilly represents and warrants that (i) Lilly has duly and properly taken all action required by law, its organizational documents or otherwise, to authorize the execution, delivery and performance of this Agreement and the other instruments to be executed and delivered by it pursuant hereto and thereto and the consummation of the transactions contemplated hereby and thereby, and (ii) this Agreement has been duly executed and delivered by Lilly and constitutes, and the other instruments contemplated hereby when duly executed and delivered by Lilly will constitute, legal, valid and binding obligations of Lilly enforceable against it in accordance with its respective terms, except as enforcement may be affected by bankruptcy, insolvency or other similar laws and by general principles of equity.

 

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5.8 Governmental Approval. Lilly represents and warrants that no consent, approval, waiver, order or authorization of, or registration, declaration or filing with, any governmental authority or any other Third Person is required in connection with the execution, delivery and performance of this Agreement, or any agreement or instrument contemplated by this Agreement, by Lilly or the performance by Lilly of its obligations contemplated hereby and thereby.

 

5.9 Brokerage. Lilly represents and warrants that no broker, finder or similar agent has been employed by or on behalf of Lilly, and no Person with which Lilly has had any dealings or communications of any kind is entitled to any brokerage commission, finder’s fee or any similar compensation in connection with this Agreement or the transactions contemplated hereby.

 

5.10 Not Debarred. Lilly represents and warrants that Lilly is not debarred and has not and will not use in any capacity the services of any Person debarred under subsections 306(a) or (b) of the Generic Drug Enforcement Act of 1992 (the “GDE Act”).

 

5.11 Litigation. Lilly represents and warrants that there are no pending or, to Lilly’s knowledge, threatened judicial, administrative or arbitral actions, claims, suits or proceedings pending as of the date hereof against Lilly or its Affiliates which, either individually or together with any other, will have a material adverse effect on the ability of Lilly to perform its obligations under this Agreement or any agreement or instrument contemplated hereby or on the ability of Licensee to develop or commercialize the Compound or Product as contemplated by the Parties.

 

5.12 Survival Period. The representations and warranties contained in this Article 5 [***] associated with such representations and warranties will [***].

 

5.13 Implied Warranties. EXCEPT AS EXPRESSLY PROVIDED IN THIS ARTICLE 5, LILLY MAKES NO REPRESENTATION OR WARRANTY AS TO THE LICENSED PATENTS OR THE LICENSED TECHNOLOGY, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND LILLY SPECIFICALLY DISCLAIMS ANY AND ALL IMPLIED OR STATUTORY WARRANTIES, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF MERCHANTABILITY, WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE AND WARRANTY OF NON-INFRINGEMENT. Without limiting the foregoing, Licensee acknowledges that it has not and is not relying upon any implied warranty of merchantability, fitness for a particular purpose, non-infringement, or upon any representation or warranty whatsoever as to the future prospects (financial, regulatory or otherwise), or the likelihood of commercial success of the Product after the date of this Agreement.

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5.14 No Third-Person Patent Infringement. Lilly represents and warrants that, to Lilly’s knowledge, there is no patent issued to a Third Person as of the Effective Date that would be infringed by any of the activities contemplated herein by the Parties.

 

5.15 Lilly Research and Development Program. Lilly represents and warrants that as of the Effective Date it does not have a research or development program in place or planned involving [***].

ARTICLE 6

REPRESENTATIONS AND WARRANTIES OF LICENSEE

 

6.1 Organization and Standing. Licensee represents and warrants that Licensee is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware.

 

6.2 Power and Authority. Licensee represents and warrants that (i) Licensee has all requisite corporate power and authority to execute, deliver and perform this Agreement and the other agreements and instruments to be executed and delivered by it pursuant hereto and thereto and to consummate the transactions contemplated herein and therein, and (ii) the execution, delivery and performance of this Agreement by Licensee does not, and the consummation of the transactions contemplated hereby will not, violate any provisions of Licensee’s organizational documents, bylaws, any law or regulation applicable to Licensee, or any agreement, mortgage, lease, instrument, order, judgment or decree to which Licensee is a party or by which Licensee is bound.

 

6.3 Corporate Action; Binding Effect. Licensee represents and warrants that (i) Licensee has duly and properly taken all action required by law, its organizational documents or otherwise, to authorize the execution, delivery and performance of this Agreement and the other instruments to be executed and delivered by it pursuant hereto and thereto and the consummation of the transactions contemplated hereby and thereby, and (ii) this Agreement has been duly executed and delivered by Licensee and constitutes, and the other instruments contemplated hereby when duly executed and delivered by Licensee will constitute legal, valid and binding obligations of Licensee enforceable against it in accordance with its respective terms, except as enforcement may be affected by bankruptcy, insolvency or other similar laws and by general principles of equity.

 

6.4 Governmental Approval. Licensee represents and warrants that no consent, approval, waiver, order or authorization of, or registration, declaration or filing with, any governmental authority or any other Third Person is required in connection with the execution, delivery and performance of this Agreement, or any agreement or instrument contemplated by this Agreement, by Licensee or the performance by Licensee of its obligations contemplated hereby and thereby

 

6.5 Brokerage. Licensee represents and warrants that no broker, finder or similar agent has been employed by or on behalf of Licensee, and no Third Person with which Licensee has had any dealings or communications of any kind is entitled to any brokerage commission, finder’s fee or any similar compensation in connection with this Agreement or the transactions contemplated hereby.

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6.6 Not Debarred. Licensee represents and warrants that Licensee is not debarred and has not and will not knowingly use in any capacity the services of any Person debarred under subsections 306(a) or (b) of the GDE Act.

 

6.7 Litigation. Licensee represents and warrants that there are no pending or, to Licensee’s knowledge, threatened judicial, administrative or arbitral actions, claims, suits or proceedings pending as of the date hereof against Licensee which, either individually or together with any other, will have a material adverse effect on the ability of Licensee to perform its obligations under this Agreement or any agreement or instrument contemplated hereby.

ARTICLE 7

ADDITIONAL COVENANTS AND AGREEMENTS.

OF THE PARTIES

 

7.1 Compliance with Law. Licensee will comply with all Applicable Laws relating to its development, manufacture, distributing, marketing, promotion, selling, importing and exporting of the Product.

 

7.2 Expenses. Lilly and Licensee will each bear their own direct and indirect expenses incurred in connection with the negotiation and preparation of this Agreement and, except as set forth in this Agreement, the performance of the obligations contemplated hereby.

 

7.3 Diligence. After the Effective Date, Licensee has sole responsibility for all aspects of developing, obtaining Regulatory Approval for, manufacturing and commercializing the Initial Product throughout the Territory. Licensee will devote Commercially Reasonable Efforts (as defined in the following sentence) to obtain and maintain Regulatory Approval for the Initial Product in the United States or to commercialize Initial Product in the United States. For purposes of this section only, “Commercially Reasonable Efforts” means the level of effort, expertise and resources that a similarly situated biopharmaceutical company would typically devote to commercialization of a product of similar marketing potential, profit potential or strategic value, based on conditions then prevailing. If Lilly believes that Licensee is not devoting Commercially Reasonable Efforts for the Initial Product in any country, Lilly will notify Licensee in writing detailing its specific concerns and recommendations, and the Parties will meet within [***] of such written notice to discuss such concerns and recommendations. After the last of such meeting(s), Licensee will have [***] to devote its Commercially Reasonable Efforts as set forth above. If Licensee subsequently defaults and does not devote Commercially Reasonable Efforts for the Initial Product in any country, Lilly will have the right to terminate the licenses granted in this Agreement to Licensee for such specific country pursuant to Section 10.1(c), below, [***], and Licensee will grant to Lilly an exclusive license to all rights, Licensee Technology and data that are useful and necessary for Lilly to obtain (or maintain) Regulatory Approval to commercialize the Initial Product in the United States.

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7.4 Publicity. The Parties agree that no publicity release or announcement concerning this Agreement will be issued without the advance written consent of the other, except as such release or announcement may be required by law, in which case the Party making the release or announcement will, before making any such release or announcement, afford the other Party a reasonable opportunity to review and comment upon such release or announcement. Notwithstanding anything in this Section 7.4 and Article 9 to the contrary, each Party may make filings that are required by Applicable Laws to the Securities and Exchange Commission (and any applicable securities exchanges) that discuss the subject matter of this Agreement or otherwise make reference to the other Party in any way whatsoever; provided, however, that such Party provides the other Party with no less than [***]; provided further, however, that, such Party will use reasonable efforts to obtain confidential treatment by such security exchanges with respect thereto.

 

7.5 Cooperation. If either Party becomes engaged in or participates in any investigation, claim, litigation or other proceeding with any Third Person, including the FDA, relating in any way to the Product, the other Party will cooperate in all reasonable respects with such Party in connection therewith, including, without limitation, using its reasonable efforts to make available to the other such employees who may be helpful with respect to such investigation, claim, litigation or other proceeding, provided that, for purposes of this provision, reasonable efforts to make available any employee will be deemed to mean providing a Party with reasonable access to any such employee at no cost for a period of time not to exceed twenty-four (24) hours ( e.g. , three (3) eight (8) -hour business days). Thereafter, any such employee will be made available for such time and upon such terms and conditions (including, but not limited to, compensation) as the Parties may mutually agree.

 

7.6 Conflicting Rights. Neither Party will grant any right to any Third Person which would violate the terms of or conflict with the rights granted by such Party to the other Party pursuant to this Agreement.

 

7.7 Deemed Breach of Covenant. Neither Lilly nor Licensee will be deemed to be in breach of this Agreement to the extent such Party’s breach is the result of any action or inaction on the part of the other Party.

 

7.8 Intellectual Property Maintenance. Licensed Patents shall be filed, prosecuted and maintained worldwide by a third-party patent counsel acceptable to Licensee and Lilly. Licensee shall have the ultimate responsibility for and control over such matters and shall bear all expenses incurred in filing, prosecuting and maintaining Licensed Patents. Licensee or its designee shall keep Lilly fully informed of the filing, prosecution and maintenance of Licensed Patents, and shall furnish to Lilly copies of documents relevant to any such efforts in advance with sufficient time for Lilly to review and provide comments on such documents, and shall use its reasonable efforts to incorporate the comments and suggestions of Lilly. Licensee shall not, without providing Lilly with

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prior written notice and sufficient time for Lilly to review and provide comment, [***]. To the extent that Lilly does not agree with any such action that is desired by Licensee, in the case of a patent application affected by such action, Lilly may file and assume control of any patent application or foreign counterpart of a patent application filed by Lilly prior to the Closing Date that Lilly wishes to pursue at Lilly’s sole expense, provided that Licensee may retain control of the parent patent application so affected. Lilly shall provide Licensee with any assistance reasonably necessary to support the filing, prosecution or maintenance of Licensed Patents. If Licensee decides to allow any Licensed Patent that is an International Patent Application (filed under the Patent Cooperation Treaty) or regional patent application (filed under the applicable regional patent convention treaty) pending as of the Closing Date to lapse without entry of the national phase in one or more countries designated in such application, or if Licensee wishes to abandon or allow to lapse any Licensed Patent that is a national patent application or patent pending or in force as of the Closing Date, Licensee shall notify Lilly in writing not less than sixty (60) days prior to taking such action, and Licensee shall thereby surrender to Lilly its rights under the patent or patent application in the country or countries so affected and Lilly may assume control of the same at Lilly’s sole expense.

 

7.9 No Fiduciary Relationship. The Parties hereby expressly agree and acknowledge that they do not intend to create any type of fiduciary relationship as a result of the provisions set forth in Section 7.8, above. Without limitation or condition of the foregoing, Lilly agrees to provide Licensee’s agent with any and all powers of attorney and other instruments necessary for Licensee to conduct the filing, prosecution or maintenance of the Licensed Patents as provided in Section 7.8, above, and Lilly acknowledges that any such power of attorney will make Licensee’s agent an attorney-in-fact for Lilly with respect to the matter specified in the power of attorney or other instrument but will not create an attorney/client relationship or any other fiduciary relationship between Lilly and Licensee’s agent. Lilly shall promptly inform Licensee as to all matters that come to Lilly’s attention that may affect the preparation, filing, prosecution, or maintenance of the Licensed Patents, including without limitation any prior art of which Lilly or any representative of Lilly knows or has reason to know is material to the preparation, filing, prosecution, or maintenance of the Licensed Patents, provided that Lilly will have no obligation beyond that required of Lilly under 37 CFR § 1.56 with respect to U.S. patent applications and that Lilly will have obligations of corresponding scope with respect to foreign patent applications as required under foreign patent regulations.

 

7.10 Enforcement of Intellectual Property Rights.

(a) Right to Seek Relief . Each Party will promptly notify the other of any infringement or suspected infringement which may come to its notice of any intellectual property rights relating to the Product, including, without limitation, the Licensed Technology, and will provide such other Party with any information with respect thereto. If a Third Person infringes any [***] the Licensed Patents or the Licensed Technology, Licensee will have the first right (but not the obligation) to pursue any and all injunctive relief, and any or all compensatory and other remedies and relief (collectively, “Remedies”), against such Third Person. Should


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Licensee determine not to pursue Remedies with respect to any such intellectual property within [***] after receipt of written notice from Lilly requesting Licensee to do so, then Lilly will have the right (but not the obligation) to pursue Remedies against such Third Person; provided, however, that such written notice from Lilly to Licensee must prominently state that Licensee must take action on the subject matter contained within the notice within [***] of Licensee’s receipt thereof.

(b) Assistance and Cooperation . If a Party pursues Remedies hereunder, the other Party will use all reasonable efforts to assist and cooperate with the Party pursuing such Remedies. Each Party will bear its own costs and expenses relating to such pursuit. Any damages or other amounts collected will be distributed, [***], to the Party that pursued Remedies to cover its costs and expenses and, [***] the other Party to cover its costs and expenses, if any, relating to the pursuit of such Remedies; any remaining amount will [***].

 

7.11 Infringement of Third Person Rights. If a Third Person institutes a patent, trade secret or other infringement suit against Licensee, a permitted sublicensee or a Permitted Seller during the term of this Agreement, alleging that the manufacture, marketing, sale or use of the Product infringes one or more patent or other intellectual property rights held by such Third Person, then Licensee will have the first right (but not the obligation), at its sole expense, to assume direction and control of the defense of such claims. Should Licensee determine not to pursue the defense of a particular claim within [***] after notice from Lilly, then Lilly will have the right (but not the obligation), at its sole expense, to assume direction and control of such claims. Licensee will not have the right to settle or otherwise dispose of any such claim without the consent of Lilly, which consent will not be unreasonably withheld.

 

7.12 No Liens. Licensee will keep the Licensed Patents and the Licensed Technology free from all liens and encumbrances.

 

7.13 Debarment. If at any time a Party uses in any capacity the services of any Person debarred under subsections 306(a) or (b) of the GDE Act, such Party will immediately notify the other Party thereof.

 

7.14 Licensee Technology. Licensee will be the sole owner of the Licensee Technology, subject to Section 7.3, above, and Section 10.2(a)(iii), below.

 

7.15 Covenant Not to Sue. [***] will not sue Licensee or any licensee of Licensee for any in infringement of any patent or other rights of [***] that may arise from the use, manufacture, sale, offer for sale or importation in the Territory by Licensee or any licensee of Licensee of any product [***].

 

7.16 Product Inventory. Licensee will use the Product Inventory (as defined in the Prior Agreement and supplied thereunder) for conducting clinical trials only and not for any commercialization purposes whatsoever. For clarity, the foregoing will not limit Licensee’s use of any product inventory manufactured after the Closing Date.

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ARTICLE 8

ASSUMPTION OF LIABILITIES BY LICENSEE

 

8.1 Assumption of Liabilities by Licensee. Except as otherwise provided in this Agreement, Licensee hereby assumes and agrees to bear and be responsible for and to perform and satisfy all responsibilities, duties (including, without limitation, compliance with all Applicable Laws), obligations, claims, Damages, liabilities, burdens and problems of any nature whatsoever that arise out of or relate to events occurring after the Effective Date (collectively, the “Obligations”) associated directly or indirectly with Licensee’s ownership, licensing, operation and/or use of the Licensed Patents and the Licensed Technology, as well as those associated directly or indirectly with the development, manufacturing, distributing, marketing, promoting or selling of the Product that arise out of or relate to events occurring after the Effective Date, including, without limitation, all recalls, all warranty claims and all product liability claims (without regard to the nature of the causes of action alleged or theories of recovery asserted) arising out of or relating to events occurring in connection with Product sold after the Effective Date, except for those Obligations with respect to which Lilly is providing indemnification pursuant to the Prior Agreement and the provisions of Section 11.1 of this Agreement, which Obligations will remain the responsibility of Lilly, and those Obligations with respect to which InterMune is providing indemnification pursuant to the Prior Agreement and the provisions of Section 2.2 of this Agreement, which Obligations will remain the responsibility of InterMune.

ARTICLE 9

CONFIDENTIALITY

 

9.1 Confidential Information. The Parties agree that, at all times during the term of this Agreement and for a [***] following its expiration or earlier termination, the Receiving Party will keep completely confidential, will not publish or otherwise disclose and will not use directly or indirectly for any purpose other than as contemplated by this Agreement any such Confidential Information of the Disclosing Party, whether such Confidential Information was received by the Receiving Party prior to, on or after the Effective Date. For clarity, Confidential Information provided under the Prior Agreement and meeting the requirements of confidentiality thereunder and hereunder will be treated as Confidential Information under this Agreement.

 

9.2 Disclosure. Subject to Section 9.1, above, each Party may disclose and, with respect only to Section 9.2(g), below, use, Confidential Information to the extent that such disclosure and, with respect only to Section 9.2(g), below, use, is:

(a) made in response to a valid order or subpoena of a court of competent jurisdiction or other governmental body of a country or any political subdivision thereof of competent jurisdiction; provided, however, that the Receiving Party will first have


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given notice to the Disclosing Party and given the Disclosing Party a reasonable opportunity to quash such order or subpoena and to obtain a protective order requiring that the Confidential Information and documents that are the subject of such order or subpoena be held in confidence by such court or governmental body or, if disclosed, be used only for purposes for which the order or subpoena was issued; provided further, however, that if a disclosure order or subpoena is not quashed or a protective order is not obtained, the Confidential Information disclosed in response to such court or governmental order or subpoena will be limited to that information that is legally required to be disclosed in such response to such court or governmental order or subpoena;

(b) otherwise required by law, in the opinion of legal counsel to the Receiving Party as expressed in an opinion letter in form and substance reasonably satisfactory to the Disclosing Party, which will be provided to the Disclosing Party at least twenty-four (24) hours prior to the Receiving Party’s disclosure of the Confidential Information pursuant to this Section 9.2;

(c) made by the Receiving Party to the governmental or regulatory authority as required to obtain or maintain marketing approval for the Product, provided that reasonable effort will be taken to ensure confidential treatment of such information;

(d) made by the Receiving Party to a Third Person as may be necessary or useful in connection with the manufacture, development and commercialization of the Product, provided that the Receiving Party will in each case obtain from the proposed Third Person recipient a written confidentiality agreement containing confidentiality obligations no less onerous than those set forth in this Section;

(e) made by the Receiving Party to a United States or foreign tax authority;

(f) made by the Receiving Party to its Representatives; provided, however, that: (i) each such Representative has a need to know such Confidential Information for purposes of this Agreement, (ii) the Receiving Party informs each Representative receiving Confidential Information of its confidential nature, and (iii) the Receiving Party will be responsible for any breach of this Section 9 by any of its Representatives to the same extent as if the breach were by the Receiving Party; and

(g) made by Licensee or any Representative of Licensee in the filing or publication of patents or patent applications relating to Licensed Patents, Licensed Technology, Licensee Technology or any invention relating to a Compound, including, without limitation, any method of use or manufacture of such Compound, conceived or reduced to practice by Licensee and/or any Representative of Licensee and or any permitted sublicensee of Licensee, to the extent such use or disclosure in the filing or publication of the patent or patent application is reasonably necessary for support of the patent or patent application.

 

9.3 Notification. The Receiving Party will notify the Disclosing Party immediately, and cooperate with the Disclosing Party as the Disclosing Party may reasonably request, upon the Receiving Party’s discovery of any loss or compromise of the Disclosing Party’s Confidential Information.

 

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9.4 Remedies. Each Party agrees that the unauthorized use or disclosure of any Confidential Information by the Receiving Party in violation of this Agreement or any other agreement forming a part of this transaction will cause severe and irreparable damage to the Disclosing Party. In the event of any violation of this Article 9, the Receiving Party agrees that the Disclosing Party will be authorized and entitled to seek from any court of competent jurisdiction injunctive relief, whether preliminary or permanent. The rights provided in the immediately preceding sentences will be cumulative and in addition to any other rights or remedies that may be available to Disclosing Party. Nothing in this Section is intended, or should be construed, to limit a Party’s right to preliminary and permanent injunctive relief or any other remedy for a breach of any other provision of this Agreement.

ARTICLE 10

TERMINATION

 

10.1 Termination. Anything herein to the contrary notwithstanding, this Agreement may be terminated as follows:

(a) Expiration . The term of this Agreement will begin upon the Effective Date and, unless sooner terminated under this Article 10, will continue in full force and effect on a country-by-country basis in the Territory until Licensee and its Permitted Sellers have no remaining Royalty Payment obligations in a specific country under Section 3.2 above. Upon expiration of the Agreement in any country pursuant to this Section, Licensee will have: (i) a fully paid-up, perpetual, irrevocable, exclusive (except as reserved by Lilly under Section 4.1, above) license in the Field with the unrestricted right to grant sublicenses under the Licensed Patents to make, use, offer to sell, sell and import Product in such country, and (ii) a fully paid-up, perpetual, irrevocable, exclusive license in the Field with the right to sublicense subject to Section 4.3, above, under the Licensed Technology to make, have made, use, offer to sell, sell and import Product in such country.

(b) Termination for Insolvency . Either Lilly or Targanta may immediately terminate this Agreement by providing written notice to the other Party if, subsequent to the Effective Date, the other Party is declared insolvent or bankrupt by a court of competent jurisdiction, or a voluntary petition of bankruptcy is filed in any court of competent jurisdiction by the other Party, or the other Party makes or executes any assignment for the benefit of creditors.

(c) Termination for Default . Either Lilly or Targanta may terminate this Agreement because of a material breach or material default of this Agreement subsequent to the Effective Date by the other Party by giving the other Party prior written notice thereof, specifying in reasonable detail the alleged material breach or material default,

 

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and if such alleged material breach or material default continues unremedied for a period of [***] with respect to monetary breaches or defaults after the date of receipt of the notification, or [***] with respect to non-monetary material breaches or material defaults after the date of receipt of the notification or, if the non-monetary material breach or material default reasonably cannot be corrected or remedied within [***], then if the defaulting Party has not in good faith commenced remedying said material breach or material default within said [***] and be diligently pursuing completion of same, then such Party may immediately terminate this Agreement by again providing written notification to the defaulting Party. This Section 10.1(c) will not be exclusive and will not be in lieu of any other remedies available to a Party hereto for any breach or default hereunder on the part of the other Party. Notwithstanding the foregoing, to the extent a material breach or material default of this Agreement by Targanta affects Targanta’s performance and Lilly’s rights under this Agreement as it relates to one or more jurisdictions, but not all jurisdictions, Lilly may terminate this Agreement in accordance with this Section 10.1(c) as to the affected jurisdiction or jurisdictions only, and in such case this Agreement will remain in full force and effect with respect to the jurisdictions not so affected.

 

10.2 Rights Upon Termination under Section 10.1.

(a) Lilly’s Rights Upon Termination for Insolvency or Default of Licensee . If Lilly terminates this Agreement under Section 10.1 (b) or (c), above, then the following will take effect:

(i) Reversion of Licensed Patents and Licensed Technology . All rights under the Licensed Patents and the Licensed Technology granted by Lilly to Licensee pursuant to Article 4, above, will terminate and all rights granted therein will immediately revert to Lilly with no further notice or action required on Lilly’s behalf; provided, however, that if the termination relates only to a specific country, then only the licenses pertaining to such country will revert to Lilly hereunder.

(ii) Reversion of Patent Maintenance Responsibilities . Upon the effective date of the termination of this Agreement, the sole responsibility for preparing, filing, prosecuting and maintaining the Licensed Patents and the Licensed Technology will revert back to Lilly with no further notice or action required on Lilly’s behalf; provided, however, that if the termination relates only to a specific country, then only the patent maintenance obligations pertaining to such country will revert to Lilly hereunder. In such case, Licensee will maintain its patent responsibilities for all other Licensed Patents and Licensed Technology.

(iii) Non-Exclusive License and Access to Licensee Technology .

(A) Initial Product(s) . Licensee will grant to Lilly a non-exclusive, world-wide, [***] license, with a right to sublicense, under Licensee Technology to the extent that it relates to Lilly’s ability to make, have made, use, offer to sell, sell and import the Initial Product solely in, and for use in, the country or countries in which Licensee’s rights to the Initial Product were so terminated. In addition to the


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license granted under this Section, Licensee also agrees to provide Lilly, at Lilly’s expense, reasonable access and reference to, copies of, and use of Licensee Technology, [***], and if Lilly so requests, the [***], to the extent [***] to make, use, offer to sell, sell and import the Initial Product in, and for use in, such country or countries.

(B) Other Products . Licensee will also grant to Lilly a non-exclusive, world-wide license, with a right to sublicense, under Licensee Technology to the extent that it relates to Lilly’s ability to make, have made, use, offer to sell, sell and import any other Products (namely, any Products other than Initial Product) solely in, and for use in, the country or countries in which Licensee’s rights to the Initial Product were so terminated. Such license shall be [***]. In addition to the license granted under this Section, Licensee also agrees to provide Lilly, at Lilly’s expense, reasonable access and reference to, copies of, and use of Licensee Technology, [***], to the extent [***] to make, use, offer to sell, sell and import such other Products in, and for use in, such country or countries.

(ii) Disposition of Product Inventory Upon Termination . If Lilly terminates this Agreement after Licensee has obtained a Regulatory Approval for the Initial Product, Licensee will offer to sell to Lilly or its designee, [***] as determined by Licensee’s records (maintained in accordance with GAAP, consistently applied) for the [***] prior to the termination, Licensee’s inventory of the Initial Product existing on the date of termination (“Licensee Product Inventory”). Licensee will be entitled to finish manufacturing any work-in-process into the Initial Product, and such newly made Initial Product will be considered Licensee Product Inventory hereunder. If termination of this Agreement relates only to a specific country, the provisions of this Subsection are applicable only to Licensee’s Initial Product inventories for the country where such termination occurred.

(b) Licensee Rights Upon Termination for Insolvency or Default of Lilly . If Licensee terminates this Agreement under Section 10.1 (b) or (c), above, then (i) the licenses under the Licensed Patents and the Licensed Technology granted by Lilly to Licensee pursuant to Article 4, above, will, unless otherwise terminated pursuant to the terms of this Agreement, remain in full force and effect, and (ii) Licensee’s diligence obligations under Section 7.3, above, will terminate. If the termination contemplated in this Section 10.2(b) is due to the default of Lilly, then in addition to the provisions of (i) and (ii), above, [***] set forth in [***] above, will be [***] and [***].

 

10.3 Termination of Sublicenses. If Lilly terminates this Agreement under Sections 10.1(b) or (c), above, and Licensee has granted sublicenses in accordance herewith, Lilly agrees

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to continue such terminated sublicensee’s license with respect to the Licensed Patents and/or Licensed Technology on [***] unless such sublicensee was in breach of this Agreement or its sublicense with Licensee on the date of such termination, in which event Lilly may terminate such sublicense in accordance with its terms.

 

10.4 Continuing Obligations. Termination of this Agreement for any reason will not relieve the Parties of any obligation accruing prior thereto and will be without prejudice to the rights and remedies of either Party with respect to any antecedent breach of the provisions of this Agreement. Without limiting the generality of the foregoing and in addition to the foregoing and the rights upon termination set forth in Section 10.2, no termination of this Agreement, whether by lapse of time or otherwise, will serve to terminate the rights and obligations of the Parties hereto with respect to this Agreement as it relates to the jurisdiction(s) for which this Agreement has not been terminated, and, with respect to those jurisdictions terminated, the rights and obligations of the Parties hereto under Sections 7.4, 7.5, 10.2, 10.3 and 10.4 and Articles 2, 3, 9, 11 and 12, and such obligations will survive any such termination.

 

10.5 Non-Exclusive Remedies. The remedies set forth in this Article 10 or elsewhere in this Agreement will be in addition to, and will not be to the exclusion of, any other remedies available to the Parties at law, in equity or under this Agreement.

ARTICLE 11

INDEMNIFICATION: INSURANCE

 

11.1 Indemnification by Lilly. Lilly will indemnify, defend and hold Licensee (and its Affiliates, and its and its Affiliates’ directors, officers and employees) harmless from and against any and all Damages incurred or suffered by Licensee (and its directors, officers and employees) to the extent caused by or arising out of or in connection with:

(a) any breach of any representation or warranty made by Lilly in this Agreement; or

(b) any failure to perform duly and punctually any covenant, agreement or undertaking on the part of Lilly contained in this Agreement;

except to the extent that such Damages are due to the negligence, gross negligence or willful misconduct of Licensee, its Affiliates, or its or its Affiliates’ employees, agents or contractors.

 

11.2 Indemnification by Licensee. Licensee will indemnify, defend and hold Lilly (and its Affiliates and its and its Affiliates’ directors, officers and employees) harmless from and against any and all Damages incurred or suffered by Lilly (and its directors, officers and employees) to the extent caused by or arising out of or in connection with:

(a) any breach of any representation or warranty made by such Licensee in this Agreement;


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(b) any failure to perform duly and punctually any covenant, agreement or undertaking on the part of such Licensee contained in this Agreement;

(c) any Assumed Liabilities except those Assumed Liabilities for which InterMune retained responsibility and liability pursuant to the Prior Agreement and Sections 2.2 and 8.1 of this Agreement;

(d) the practice of the Licensed Patents and Licensed Technology by such Licensee, its Affiliates, and any sublicensees;

(e) the handling, possession, development, marketing, distribution, promotion, sale or use of the Product by such Licensee or a Permitted Seller after the Effective Date including, but not limited to, any Third Person claim alleging breach of any express or implied warranties of merchantability or fitness for a particular purpose or asserting strict liability, except to the extent such Damage is caused by a breach of this Agreement by Lilly; or

(f) Such Licensee’s failure to comply in all material respects with Applicable Laws in connection with the performance of its obligations hereunder;

except to the extent that such Damages are due to the negligence, gross negligence or willful misconduct of Lilly, its Affiliates or its or its Affiliates’ employees, agents or contractors.

 

11.3

Notice and Opportunity To Defend. Promptly after receipt by a Party hereto of notice of any claim which could give rise to a right to indemnification pursuant to Section 11.1 or 11.2, above, such Party (the “Indemnified Party”) will give the other Party (the “Indemnifying Party”) written notice describing the claim in reasonable detail. The failure of an Indemnified Party to give notice in the manner provided herein will not relieve the Indemnifying Party of its obligations under this Article 11, except to the extent that such failure to give notice materially prejudices the Indemnifying Party’s ability to defend such claim. The Indemnifying Party will have the right, at its option, to compromise or defend, at its own expense and by its own counsel, any such matter involving the asserted liability of the Party seeking such indemnification; provided, however, that the Indemnifying Party may do so under a reservation of rights with respect to the obligation to indemnify. If the Indemnifying Party will undertake to compromise or defend any such asserted liability, it will promptly (and in any event not less than ten (10) days after receipt of the Indemnified Party’s original notice) notify the Indemnified Party in writing of its intention to do so, and the Indemnified Party agrees to cooperate fully with the Indemnifying Party and its counsel in the compromise or defend against any such asserted liability. All reasonable costs and expenses incurred in connection with such cooperation will be borne by the Indemnifying Party subject to the Indemnifying Party’s reservation of rights. If the Indemnifying Party elects not to compromise or defend the asserted liability, or fails to notify the Indemnified Party of its election to compromise or defend as herein provided, the Indemnified Party will have the right, at its option, to pay, compromise or defend such asserted liability by its own counsel and its reasonable costs, expenses, and any payment made therewith will be included as part of

 

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the indemnification obligation of the Indemnifying Party hereunder, subject to the Indemnifying Party’s reservation of rights. Notwithstanding the foregoing, neither the Indemnifying Party nor the Indemnified Party may settle or compromise any claim without consent of the other; provided, however, that consent to settlement or compromise will not be unreasonably withheld. In any event, the Indemnified Party and the Indemnifying Party may participate, at their own expense, in the defense of such asserted liability. If the Indemnifying Party chooses to defend any claim, the Indemnified Party will make available to the Indemnifying Party any books, records or other documents within its control that are necessary or appropriate for such defense; provided, however, any such books, records or other documents within the control of the Indemnified Party which are made available to the Indemnifying Party hereunder will be held in strict confidence by the Indemnifying Party and will be disclosed by the Indemnified Party to the Indemnifying Party only to the extent that such books, records or other documents relate to the claim.

Notwithstanding anything to the contrary in this Section 11.3, (a) the Party conducting the defense of a claim will (1) keep the other Party informed on a reasonable and timely basis as to the status of the defense of such claim (but only to the extent such other Party is not participating jointly in the defense of such claim), and (2) conduct the defense of such claim in a prudent manner, and (b) the Indemnifying Party will not cease to defend, settle or otherwise dispose of any claim without the prior written consent of the Indemnified Party (which consent will not be unreasonably withheld).

 

11.4 Indemnification Payment Obligation. Neither Party will incur any indemnification obligations under this Article 11 until [***], at which time [***] such Damages will be covered. The provisions of this Section will not limit or otherwise affect the obligations of any Indemnifying Party under any other Section.

 

11.5 Indemnification Payment Adjustments. The amount of any Damages for which indemnification is provided under this Article 11 will be reduced by the insurance proceeds received and any other amount recovered, if any, by the Indemnified Party with respect to any Damages; provided, however, that the foregoing will not under any circumstances reduce the Damages for which either Party is obligated to indemnify the other to the extent the insurance proceeds received result from a self-insurance program; provided further, however, that an Indemnified Party will not be subject to an obligation to pursue an insurance claim relating to any Damages for which indemnification is sought hereunder. To the extent the preceding sentence is applicable, if any Indemnified Party will have received any payment pursuant to this Article 11 with respect to any Damages and will subsequently have received insurance proceeds or other amounts with respect to such Damages, then such Indemnified Party will pay to the Indemnifying Party an amount equal to the difference (if any) between (a) the sum of the amount of those insurance proceeds or other amounts received and the amount of the payment by such Indemnifying Party pursuant to this Article 11 with respect to such Damages and (b) the amount necessary to fully and completely indemnify and hold harmless such Indemnified

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Party from and against such Damages; provided, however, that in no event will such Indemnified Party have any obligation pursuant to this sentence to pay to such Indemnifying Party an amount greater than the amount of the payment by such Indemnifying Party pursuant to this Article 11 with respect to such Damages.

 

11.6 Indemnification Payment. Upon the final determination of liability and the amount of the indemnification payment under this Article 11, the Indemnifying Party will pay to the Indemnified Party, within ten (10) business days after such determination, the amount of any claim for indemnification made hereunder.

 

11.7 Limitation of Liability. IN NO EVENT WILL EITHER PARTY BE LIABLE FOR INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL (INCLUDING LOST PROFITS) OR PUNITIVE DAMAGES, HOWEVER CAUSED OR UPON ANY THEORY OF LIABILITY (INCLUDING A PARTY’S OR ITS AFFILIATES’ OWN NEGLIGENCE, GROSS NEGLIGENCE OR WILLFUL MISCONDUCT OR THE NEGLIGENCE, GROSS NEGLIGENCE OR WILLFUL MISCONDUCT OF A PARTY’S OR A PARTY’S AFFILIATES’ EMPLOYEES, AGENTS OR CONTRACTORS), ARISING OUT OF THIS AGREEMENT OR THE PERFORMANCE OF, OR THE FAILURE TO PERFORM, ANY OBLIGATION(S) SET FORTH HEREIN.

 

11.8 Insurance. Licensee will maintain at its own expense, [***] to Lilly, full insurance coverage for Licensee, written on a per occurrence basis, which will [***], including, without limitation, errors and omissions insurance encompassing claims relating to Licensee’s performance of its obligations under this Agreement and comprehensive general liability insurance for claims for damages arising from bodily injury (including death) and property damages arising out of acts or omissions of Licensee, [***]. Minimum limits of such insurance (not [***]) will be [***] coverage. Maintenance of such insurance coverage will not relieve Licensee of any responsibility under this Agreement for damage in excess of insurance limits or otherwise. Licensee will provide Lilly with a certificate from the insurer(s), evidencing such insurance coverage and the insurer’s agreement to notify Lilly [***] such insurance coverage.

 

11.9 Survival. Each Indemnified Party’s rights under Article 11 will not be deemed to have been waived or otherwise affected by such Indemnified Party’s waiver of the breach of any representation, warranty, agreement or covenant contained in or made pursuant this Agreement, unless such waiver expressly and in writing also waives any or all of the Indemnified Party’s right under Article 11.

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ARTICLE 12

MISCELLANEOUS

 

12.1 Successors and Assigns. This Agreement will be binding upon and will inure to the benefit of the Parties hereto and their respective successors and assigns, and either Lilly or Licensee may assign this Agreement without the prior written consent of the other. No assignment of this Agreement or of any rights hereunder will relieve the assigning Party of any of its obligations or liability hereunder.

 

12.2 Notices. Unless otherwise stated in this Agreement as to the method of delivery, all notices or other communications required or permitted to be given hereunder will be in writing and will be deemed to have been duly given if delivered by hand, courier, facsimile or if mailed first class, postage prepaid, by registered or certified mail, return receipt requested (such notices will be deemed to have been given on the date delivered in the case of hand delivery or delivery by courier, on the date set forth in the confirmation sheet in the case of facsimile delivery, and on the date of post mark in the case of delivery by mail) as follows:

If to Lilly, as follows:

Eli Lilly and Company

Lilly Corporate Center

Indianapolis, Indiana 46285

Facsimile: (317) 277-7979

Attn: Vice President, Corporate Business Development

With a copy to:

Eli Lilly and Company

Lilly Corporate Center

Indianapolis, Indiana 46285

Facsimile: (317) 433-3000

Attn: General Counsel

If to Licensee, as follows:

InterMune, Inc.

3280 Bayshore Boulevard

Brisbane, California 94005

Facsimile: (415) 466-2300

Attn: Senior Vice President of Corporate Development

 

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With a copy to:

InterMune, Inc.

3280 Bayshore Boulevard

Brisbane, California 94005

Facsimile: (415) 508-0006

Attn: General Counsel

or in any case to such other address or addresses as hereafter will be furnished in a written notice as provided in this Section 12.2 by any Party hereto to the other Party.

 

12.3 Waiver. Any term or provision of this Agreement may be waived at any time by the Party entitled to the benefit thereof only by a written instrument executed by such Party. No delay on the part of Lilly or Licensee in exercising any right, power or privilege hereunder will operate as a waiver thereof, nor will any waiver on the part of either Lilly or Licensee of any right, power or privilege hereunder operate as a waiver of any other right, power or privilege hereunder nor will any single or partial exercise of any right, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, power or privilege hereunder.

 

12.4 Entire Agreement. This Agreement, including the exhibits and schedules attached hereto and the certificates delivered in connection herewith and therewith constitute the entire agreement between the Parties with respect to the subject matter hereof and supersede all prior agreements or understandings of the Parties relating thereto, including that certain Confidential Disclosure Agreement, dated as of August 1, 2001.

 

12.5 Amendment. This Agreement may be modified or amended only by written agreement of the Parties hereto signed by authorized representatives of the Parties.

 

12.6 Counterparts. This Agreement may be executed in any number of counterparts, each of which will be deemed an original but all of which together will constitute a single instrument.

 

12.7 Governing Law. This Agreement will be governed and construed in accordance with the laws of the State of New York excluding any choice of law rules that may direct the application of the law of another state.

 

12.8 Captions. All section titles or captions contained in this Agreement and in any exhibit, schedule or certificate referred to herein or annexed to this Agreement are for convenience only, will not be deemed a part of this Agreement and will not affect the meaning or interpretation of this Agreement.

 

12.9 No Third-Person Rights. No provision of this Agreement will be deemed or construed in any way to result in the creation of any rights or obligation in any Person not a Party to this Agreement.

 

12.10 Construction. This Agreement will be deemed to have been drafted by both Lilly and

 

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Licensee and will not be construed against either Party as the draftsperson hereof.

 

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12.11  Appendices, Exhibits, Schedules and Certificates. Each appendix, exhibit, schedule and certificate attached hereto is incorporated herein by reference and made a part of this Agreement.

 

12.12  No Joint Venture. Nothing contained herein will be deemed to create any joint venture or partnership between the Parties hereto, and, except as is expressly set forth herein, neither Party will have any right by virtue of this Agreement to bind the other Party in any manner whatsoever.

 

12.13  Severability. If any provision of this Agreement is held to be illegal, invalid, or unenforceable under present or future laws effective while this Agreement remains in effect, the legality, validity and enforceability of the remaining provisions will not be affected thereby.

 

12.14  Force Majeure. If either Party is prevented from complying, either totally or in part, with any of the terms or provisions set forth herein by reason of force majeure, including, by way of example and not of limitation, fire, flood, explosion, storm, strike, lockout or other labor dispute, riot, war, rebellion, accidents, acts of God, acts of governmental agencies or instrumentalities, failure of suppliers or any other similar or dissimilar cause, in each case to the extent beyond its reasonable control, said Party will provide written notice of same to the other Party. Said notice will be provided within [***] of the occurrence of such event and will identify the requirements of this Agreement or such of its obligations as may be affected, and, subject to Section 3.8, to the extent so affected, said obligations will be suspended during the period of such disability. The Party prevented from performing hereunder will use reasonable efforts to remove such disability and will continue performance whenever such causes are removed. The Party so affected will give to the other Party a good faith estimate of the continuing effect of the force majeure condition and the duration of the affected Party’s nonperformance. If the period of any previous actual nonperformance of Lilly because of Lilly force majeure conditions plus the anticipated future period of Lilly nonperformance because of such conditions will exceed an aggregate of [***], Licensee may terminate this Agreement immediately by written notice to Lilly. If the period of any previous actual nonperformance of Licensee because of Licensee force majeure conditions plus the anticipated future period of Licensee nonperformance because of such conditions will exceed an aggregate of [***], Lilly may terminate this Agreement immediately by written notice to Licensee. When such circumstances as those contemplated herein arise, the Parties will discuss in good faith, what, if any, modification of the terms set forth herein may be required in order to arrive at an equitable solution.

 

12.15  Independent Contractors. It is understood and agreed that the Parties are independent contractors and are engaged in the operation of their own respective businesses, and neither Party is to be considered the agent of the other Party for any purpose whatsoever. Neither Party will have any authority to enter into any contracts, assume any obligations, create any liability, nor make any warranties or representations for or on behalf of the other Party.

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12.16  Change of Control. If any Third Person makes a good faith written offer to Licensee to acquire the right to control the majority of the voting stock of Licensee, and if such Third Person potential acquirer has a [***] in place, then Licensee will promptly notify Lilly of its receipt of such an offer.

 

12.17  Dispute Resolution. If any dispute arises relating to this Agreement, prior to instituting any lawsuit, arbitration or other dispute resolution process on account of such dispute, the Parties will attempt in good faith to settle such dispute first by negotiation and consultation between themselves, including referral of such dispute to the Chief Executive Officer of Licensee and the Vice President, Corporate Business Development, of Lilly. If said executives are unable to resolve such dispute or agree upon a mechanism to resolve such dispute within sixty (60) days of the first written request for dispute resolution under this Section 12.16, the Parties may then either consider other forms of alternative dispute resolution as a means of resolving any such dispute or institute litigation and seek such remedies as may be available.

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IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the date first above written.

 

ELI LILLY AND COMPANY
By:   /s/ John C. Lechleiter
Printed Name: John C. Lechleiter

Title: President & Chief Operating

Officer

 

INTERMUNE, INC.
By:   /s/ Thomas Kassberg
Printed Name: Thomas Kassberg

Title: Senior Vice President, Business

Development and Corporate Strategy

 

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Exhibit A

Licensed Patents

[***]


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Schedule 1.22

InterMune’s Exchange Rate Methodology

All payments to be made under this Agreement shall be made in U.S. Dollars. For those sales involving Product which occur outside the United States, the Royalty Payments due on such sales will be calculated on the basis of the local currency sales figures translated into United States Dollars according to InterMune’s then current standard currency translation methodology. The methodology employed by InterMune shall be that methodology used by InterMune in the translation of its foreign currency operating results for external reporting and shall be consistent with United States GAAP.

 

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EXHIBIT 10.16

[*] = CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

DEVELOPMENT AND SUPPLY AGREEMENT

This Agreement is entered into this 28th day of December, 2001, by and between Abbott Laboratories, an Illinois corporation having a principal place of business at 100 Abbott Park Road, Abbott Park, Illinois 60064-3500 (“Abbott”), and InterMune, Inc. a Delaware corporation , having a principal place of business at 3280 Bayshore Boulevard, Brisbane, CA 94005 (“InterMune”).

WHEREAS , InterMune is the owner of certain technology and patent rights regarding the compound Oritavancin, which is used as a drug for a broad range of resistant gram-positive bacterial infections;

WHEREAS , InterMune will file for approval with the United States Food and Drug Administration (and its foreign equivalents), a New Drug Application (and its foreign equivalents), for certain formulations containing Bulk Drug Substance, as defined below;

WHEREAS , InterMune has certain process information relating to the synthesis of Bulk Drug Substance and desires to have Abbott evaluate such information and to scale-up and adapt the current manufacturing process for the preparation of Bulk Drug Substance to Abbott facilities;

WHEREAS , Abbott possesses process engineering capabilities and operates process development facilities, which include small scale Bulk Drug Substance and a pilot plant, as well as large scale facilities for the Bulk Drug Substance of commercial quantities of certain Bulk Drug Substances;

WHEREAS , Abbott desires to evaluate InterMune process information and scale-up and adapt the current manufacturing process for the preparation of Bulk Drug Substance to Abbott facilities; and

WHEREAS , Abbott desires to manufacture for InterMune developmental, clinical and commercial quantities of Bulk Drug Substance and InterMune desires to purchase from Abbott such quantities.

NOW, THEREFORE , in consideration of the premises set forth above and the mutual covenants and agreements contained herein, the parties hereto agree as follows:

 

1. Definitions

As used in this Agreement, the following words and phrases shall have the following meanings:

1.1 “ Abbott Know-How ” means all non-patented technical data, drawings, documentation, analytical and regulatory information and other information, including all improvements thereto, not included in Abbott Patent Rights, as defined below, covering [*] that is owned by Abbott, or licensed to Abbott, with the right to sublicense, as of the Effective Date, as defined below, or generated or acquired by Abbott during the term of this Agreement.

1.2 “ Abbott Patent Rights ” means United States and foreign patents and patent applications, including divisions, continuations, continuations-in-part, additions, renewals, extensions, re-examinations and reissues of all such patents and patent applications, all as are owned by Abbott, or licensed by Abbott, with the right to sublicense, claiming [*] .

1.3 “ Affiliate ” of a party hereto means any entity that controls, is controlled by, or is under common control with such party. For purposes of this definition, a party shall be deemed to control another entity if it owns or controls, directly or indirectly, at least fifty percent (50%) of the voting equity of the other entity (or other comparable ownership interest for an entity other than a corporation).


* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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1.4 “ Bulk Drug Substance ” means the bulk form of Oritavancin [*] , as more fully described in Exhibit A .

1.5 “ Bulk Drug Substance Specifications ” means the written specifications for Bulk Drug Substance set forth in Exhibit B and as they will be further defined in the scope of this Project and as modified from time to time pursuant to Section 7.3.

1.6 “ cGMP ” means the FDA’s current good manufacturing practices, as specified in the Code of Federal Regulations and FDA’s guidance documents, and all successor regulations and guidance documents thereto.

1.7 “ CMC ” means the Chemistry and Manufacturing Controls (or its foreign equivalents) filed with the FDA in support of the Bulk Drug Substance NDA.

1.8 “ Confidential Information ” means all information, including, but not limited to, InterMune Know-How and Abbott Know-How disclosed pursuant to this Agreement in writing (or all information disclosed orally, visually and/or in another tangible form which is summarized in writing as to its general content within thirty (30) days after original disclosure and identified as being confidential), except any portion thereof that:

(a) is known to the recipient, as evidenced by its written records before receipt thereof under this Agreement;

(b) is disclosed to the recipient without restriction after acceptance of this Agreement by a third person who has the right to make such disclosure;

(c) is or becomes part of the public domain through no fault of the recipient; or

(d) is independently developed by or for the recipient by individuals or entities who have not had access to Confidential Information, as evidenced by its written records.

1.9 “ Contract Year ” shall mean a period of twelve (12) consecutive months which, for the first Contract Year of this Agreement, shall commence on Launch Date and each Contract Year thereafter shall consist of twelve (12) consecutive months following the end of the preceding Contract Year.

1.10 “ DMF ” means the Drug Master File filed with the FDA in support of the Bulk Drug Substance NDA.

1.11 “ Effective Date ” means the date of the effectiveness of this Agreement, and that date shall be August 30, 2001.

1.12 “ EMEA ” shall mean the European Medicine Evaluation Agency, or any successor entity thereto.

1.13 “ FDA ” means the United States Food and Drug Administration (or its foreign equivalents), or any successor entity thereto.

1.14 “ Launch Date ” means the date on which the first commercial sale made in the Territory by InterMune or any InterMune co-marketer, distributor or sublicensee of drug Product derived from Bulk Drug Substance.

1.15 “ NDA ” means the New Drug Application (or its foreign equivalent) filed with the FDA, seeking authorization to market Bulk Drug Substance in the Territory.

1.16 “ Product ” means any pharmaceutical product containing Bulk Drug Substance as its active ingredient.


* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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1.17 “ Project ” means a multi-stage project to adapt the process for the manufacture of Bulk Drug Substance to support global Regulatory Filings, as mutually agreed upon by the parties and necessary to support the commercial filing for the Bulk Drug Substance.

1.18 “ Proposal ” means the description of the Project, as set forth in Exhibit C .

1.19 “ Regulatory Filings ” means the governmental filings required to obtain approval to market Bulk Drug Substance in a given country, including, but not limited to, Bulk Drug Substance registration(s) and marketing approval(s), as applicable, in each country.

1.20 “ Regulatory Authorities ” means the FDA, the EMEA, or any comparable national or territorial regulatory entity.

1.21 “ InterMune Know-How ” means all non-patented technical data, drawings, documentation, analytical and regulatory information and other information, including all improvements thereto, not included in InterMune Patent Rights, as defined below, [*] that is owned by InterMune, or licensed to InterMune, with the right to sublicense, as of the Effective Date or generated or acquired by InterMune during the term of this Agreement.

1.22 “ InterMune Patent Rights ” means United States and foreign patents and patent applications, including divisions, continuations, continuations-in-part, additions, renewals, extensions, re-examinations and reissues of all such patents and patent applications, all as are owned by InterMune, or licensed to InterMune, with the right to sublicense, claiming [*] and under which Abbott would need a license or sublicense to lawfully manufacture Bulk Drug Substance for InterMune under this Agreement.

1.23 “ Territory ” means the world.

 

2. Bulk Drug Substance Development Project

Promptly after the Effective Date, Abbott shall undertake the Project. The Project shall consist of research, development, manufacturing, and regulatory activities described in the Proposal in accordance with Exhibit C. Abbott shall use its [*] in performing its research and development activities hereunder, but InterMune understands that, because the Project involves research from which the results are inherently uncertain, Abbott cannot and does not make any representation, warranty or guarantee of any kind that the Project will result in [*] Abbott shall use [*] to complete project milestones as set forth in Exhibit C in a timely manner. Failure to complete a milestone shall [*] of [*] a [*] .

 

3. Abbott’s Research and Development Activities

3.1   Abbott’s Activities . The objective of the Project shall be for Abbott to develop and manufacture Bulk Drug Substance and to support InterMune’s Regulatory Filings as appropriate. Therefore, Abbott shall conduct and perform what will be reasonably anticipated to achieve such objectives, including, but not limited to, the following:

(a) Sourcing raw materials for use in manufacturing Bulk Drug Substance;

(b) Performing pilot scale evaluation of InterMune’s manufacturing process;

(c) Adapting InterMune’s manufacturing process to Abbott’s equipment and systems;

(d) Developing commercial process parameters to manufacture Bulk Drug Substance in Abbott’s manufacturing facility;

(e) Preparing suitable manufacturing instructions, manufacturing controls and quality documents for inclusion in the CMC section of Regulatory Filings;


* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(f) Providing appropriate Regulatory Authorities with letters of authorization referencing Abbott’s DMF and containing process validation data, batch documents and other data required to support and enable Regulatory Filings and to assist InterMune in responding to questions from Regulatory Authorities concerning the Bulk Drug Substance;

(g) Conducting material contact and cleaning validation studies, engineering and validation runs, process validation studies, and preparing process justification and validation summary reports, in a timely manner, to pass FDA pre-approval and other appropriate Regulatory Authority inspections to support manufacture of the Bulk Drug Substance in the Abbott manufacturing facility;

(h) Permitting InterMune to conduct [*] cGMP and quality assurance reviews of Abbott documentation, including review and receipt of copies of Abbott manufacturing work orders;

(i) Permitting InterMune to [*] and compounds as they relate to Bulk Drug Substance manufacture only;

(j) Providing InterMune with acceptable environmental impact statements for inclusion with Regulatory Filings, if required;

(k) Providing InterMune with appropriate pilot and commercial scale batch record manufacturing documentation for Regulatory Filings;

(l) Conducting stability testing on Bulk Drug Substance and compiling data for Regulatory Filing;

(m) Preparation for and administration of the FDA pre-approval inspection;

(n) Manufacturing development supplies, clinical supplies, stability supplies and process validation batches of Bulk Drug Substance in accordance with current cGMP’s and pursuant to protocols [*] ;

(o) [*] the clinical and marketed Bulk Drug Substance as agreed upon in the Proposal; and

(p) [*] Project progress reports will be provided, in addition to timely meetings, mutually agreed upon by the parties, with InterMune to communicate key activities, updates, changes, etc. to the Project.

 

4. InterMune’s Research and Development Activities

4.1   InterMune’s Activities . InterMune shall conduct and perform research and development activities, including, but not limited to the following:

(a) Providing Abbott with all [*] for raw materials, in-process tests and manufacture of Bulk Drug Substance and all available reference materials;

(b) Providing Abbott with technical data on Bulk Drug Substance that includes, but is not limited to, the following: (i) material safety data sheets with environmental and safety information, and (ii) additional detailed data, if necessary, to define potential hazards and establish employee exposure levels;

(c) Providing Abbott with copies of Regulatory Filings as necessary for Abbott to obtain regulatory pre-inspection approval; and

(d) Review and approve records necessary for NDA filing as outlined in the Quality Agreement covered in section 8.3.


* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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5. Payment for Abbott’s Development Efforts

5.1   Research and Development Fee . To reimburse Abbott for its participation in the Project, InterMune shall pay Abbott a [*] research and development fee [*] . The research and development fee (“Fee”) shall be paid to Abbott as follows:

(a) [*] immediately upon agreement of technology transfer and receipt of Abbott’s invoice for the amount due. This fee represents [*] .

(b) The remainder of the Fee will be invoiced and paid according to the annual payment schedule in Exhibit C . Installments shall be paid within [*] of the receipt of each [*] Abbott invoice for the amount due. Invoices shall accompany [*] from the previous [*] .

5.2   Changes in Project Scope . If changes occur in the Project scope [*] Abbott shall provide InterMune with a new or revised test protocol with estimates for such work. If InterMune approves such fees and protocol, Abbott shall perform such work and InterMune shall pay Abbott for such work within [*] of completion of such work. Reimbursement for such additional work shall be at the rate of [*] .

5.3   Additional Costs . InterMune shall pay Abbott for its [*] pre-approved by InterMune associated with any FDA filing [*] by Abbott requested by InterMune. InterMune also shall pay Abbott’s [*] pre-approved by InterMune for any work requested by InterMune to produce and assemble documentation for Bulk Drug Substance registrations outside the United States.

 

6. Pilot Scale and Clinical Supplies

6.1   Pilot Scale/Clinical Supplies . Abbott shall provide to InterMune pilot/clinical scale supplies consisting of approximately [*] of Bulk Drug Substance totaling no less than [*] that meet the mutually defined Bulk Drug Substance specifications. InterMune shall notify Abbott of any alteration of the Pilot Scale/Clinical Supplies and Bulk Drug Substance amount.

6.2   Validation Supplies . Abbott shall provide to InterMune validation supplies consisting of [*] of Bulk Drug Substance totaling no less than [*] that meet the mutually defined Bulk Drug Substance specifications. InterMune shall notify Abbott of any alteration of the validation schedule and Bulk Drug Substance amount.

6.3   Revisions to Schedule . InterMune and Abbott currently anticipate that pilot scale/clinical development and validation supplies shall be delivered in accordance with the schedule included in the Proposal. In the event that InterMune communicates to Abbott a need to change such schedule, InterMune and Abbott shall then develop jointly and agree mutually to a revised pilot scale and clinical development schedule. In the event that there is a change in the pilot scale and clinical development schedule that has not been communicated by InterMune to Abbott [*] the parties shall mutually agree to [*] such schedule.

 

7. Manufacture and Commercial Supply of Bulk Drug Substance

7.1   Purchase and Sale of Bulk Drug Substance . Pursuant to the terms and conditions of Section 7.1 and for the duration of this Agreement, Abbott shall manufacture, sell and deliver Bulk Drug Substance exclusively to InterMune, and InterMune shall purchase [*] in the Territory [*] from Abbott. In the event that Abbott cannot deliver sufficient Bulk Drug Substance to meet InterMune’s needs, InterMune shall have the right to [*] manufacture, sell and deliver such undelivered amounts of Bulk Drug Substance to InterMune [*] and Abbott shall provide such reasonable support [*] as requested by InterMune to assist in such technology transfer solely for purposes of this Section. Abbott shall manufacture Bulk Drug Substance in accordance with the Bulk Drug Substance Specifications that


* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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the parties shall mutually develop. As provided in Section 7.3, the parties may alter from time to time the Bulk Drug Substance Specifications by written agreement without amending this Agreement.

7.2   [*]  During the term of this Agreement and including the term of all extensions [*] InterMune covenants to [*] of Bulk Drug Substance [*] If InterMune does not [*] during the [*] shall [*] by any [*] within [*] after the termination of the Agreement pursuant to Section 12.1. Such [*] shall be calculated by taking the [*] The [*] assigned to any such [*] shall be the [*] of Bulk Drug Substance [*] by InterMune as evidenced by InterMune’s [*] by Abbott. Abbott may agree, [*] to [*] such [*] Notwithstanding the first four sentences of this Section 7.2, if at any time [*] InterMune notifies Abbott of [*] the [*] shall be [*] Bulk Drug Substance. Notwithstanding the first four sentences of this Section 7.2, if at any time after the [*] InterMune notifies Abbott of [*] the [*] shall be [*] Bulk Drug Substance. Should it become at any time [*] the manufacturing capacity at Abbott [*] Bulk Drug Substance for any [*] forecast [*] Abbott will notify InterMune in writing [*] in advance.

7.3   Modification of Bulk Drug Substance Specifications.  If the Bulk Drug Substance Specifications are modified by InterMune hereunder or the Bulk Drug Substance Specifications must be modified by requirement of the FDA or other regulatory agency, or a process change would be required under the CMC, or other applicable governmental application, and such modification or process change [*] Bulk Drug Substance, Abbott shall [*] for either the current or future stage of development or Bulk Drug Substance that [*] Abbott and InterMune shall [*] of such change. In the event the parties are unable to agree on such [*] Abbott may (i)  [*] or (ii)  [*] If such modification results in the requirement to reprocess and/or retest previously manufactured and otherwise acceptable Bulk Drug Substance, any additional costs incurred by Abbott in such reprocessing and/or retesting shall be paid by InterMune upon submission by Abbott of documentation and justification of such costs.

7.4   Modification of Bulk Drug Substance Process . Process changes by Abbott that affect InterMune’s Bulk Drug Substance DMF or CMC shall not occur without prior written permission of InterMune.

 

8. Manufacture of Bulk Drug Substance

8.1   Bulk Drug Substance Title and Shipment . Any Bulk Drug Substance manufactured by Abbott pursuant to this Agreement shall be shipped [*] . Title and risk of loss shall pass to InterMune [*] of Bulk Drug Substance to [*] . Shipment shall be via a carrier designated by InterMune.

8.2   Bulk Drug Substance Storage . InterMune shall pay Abbott at a rate of [*] for any Bulk Drug Substance storage costs incurred by Abbott [*] after manufacture and release, provided that such Bulk Drug Substance was forecasted by InterMune. In the event that InterMune enters into a separate agreement with Abbott for the fill and finish of Product, Bulk Drug Substance will be stored [*] .

8.3   Quality Control . Abbott shall apply its quality control procedures and in-plant quality control checks on the manufacture of Bulk Drug Substance for InterMune in the same manner as Abbott applies such procedures and checks to bulk drug substance of similar nature manufactured for sale by Abbott. Abbott will test and release Bulk Drug Substance to InterMune in accordance with the Bulk Drug Substance Specifications described in Exhibit B . In addition, Abbott will issue a certificate of GMP compliance for Bulk Drug Substance manufactured under GMP for InterMune.

(a) Stability Studies . Abbott shall conduct adequate and necessary stability studies for FDA requirements and [*] stability studies required by EMEA regulations for InterMune on pilot plant stability and commercial scale validation Bulk Drug Substance that is manufactured pursuant to this Agreement. Such stability studies shall be conducted per the stability protocol approved by InterMune and Abbott and included in Abbott’s Bulk Drug Substance DMF. The cost of conducting such stability studies is included in the Proposal, as set forth in Exhibit C .


* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(b) Quality Assurance . Within [*] after the date of the signing of this Agreement, representatives of the parties’ Quality Assurance departments shall meet to develop and approve a quality agreement (“Quality Agreement”) outlining the responsibilities and key contacts for quality and compliance related issues. Items to be included in the Quality Agreement include, but are not limited to recalls, annual product reviews, returned goods, regulatory audits, compliance with cGMP, compliance with such other quality related concerns deemed appropriate.

8.4   Audits . Upon Abbott’s written approval, which approval shall not be unreasonably withheld, InterMune, shall have the right, [*] prior written notice to Abbott, to conduct during normal business hours a quality assurance audit and inspection of Abbott’s records and Bulk Drug Substance facilities relating to the manufacture of Bulk Drug Substance, and to perform follow-up audits as reasonably necessary. Such audits and inspections may be conducted [*] prior to Bulk Drug Substance production of the first commercial Bulk Drug Substance order placed by InterMune and thereafter [*] each calendar year. The duration of such audits shall not exceed [*] and such audits shall be performed by no more than [*] , unless InterMune reasonably believes that a longer audit or additional personnel are necessary and provides its reasons for such belief to Abbott in writing. If InterMune wishes to perform audits more often than [*] per year or over a period in excess of [*] , InterMune shall [*] . Notwithstanding the foregoing, in the event that InterMune requires an audit due to quality issues that arise during any Contract Year, InterMune shall be entitled to [*] . If more than [*] perform the audit, InterMune shall [*] .

Visits by InterMune to Abbott’s Bulk Drug Substance facilities may involve the transfer of Confidential Information, and any such Confidential Information shall be subject to the terms of Article 11 hereof. The results of such audits and inspections shall be considered Confidential Information under Article 11 and shall not be disclosed to third persons, including but not limited to the FDA and any other Regulatory Authority, unless required by law and upon prior written notice to Abbott.

If InterMune utilizes auditors that [*] each of such auditors shall execute a non-disclosure agreement with confidentiality terms at least as stringent as those set forth herein.

Abbott shall be responsible for inspections of its North Chicago manufacturing facility by FDA or an equivalent Regulatory Authority and shall notify InterMune if such inspections are [*] to the manufacture of InterMune’s Bulk Drug Substance. InterMune may be present for any such audit.

8.5 Price and Payment Terms for Commercial Quantities of Bulk Drug Substance .

(a) Price . For the first [*] Contract Years following the Launch Date Abbott shall sell to InterMune Bulk Drug Substance at a rate of [*] . Thereafter commencing with the [*] Contract Year following the Launch Date, [*] of Bulk Drug Substance sold to InterMune by [*] per Contract Year based on expected yield improvements and cost savings from production experience and optimization of conditions identified during process development and validation. Additionally, Abbott shall provide [*] an [*] of Bulk Drug Substance sold to InterMune for each [*] that InterMune purchases per Contract Year [*] . A numerical example of the manner in which the calculation will be made is attached hereto as Exhibit D . Notwithstanding the foregoing, at no time during the term of this Agreement shall the price of Bulk Drug Substance sold to InterMune be [*] Abbott’s [*] . Any [*] shall be based on [*] . Upon reasonable notice to Abbott, InterMune shall have the right to have an independent certified public accountant selected by InterMune and acceptable to Abbott, examine Abbott’s records during normal business hours to confirm payments made hereunder. Such audit shall not take place more frequently than [*] per year and shall not cover records for more than [*] preceding years. InterMune will bear the full cost of such audit unless such audit discloses a variance of more than [*] from the amount of the applicable payment owed. In such case,


* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Abbott will bear the full cost of such audit. All information obtained during and resulting from such audits conducted shall be kept confidential according to Section 11.

(b) Payment . InterMune shall make payment [*] from the date of receipt of Abbott’s invoice. All payments due under this Agreement shall be paid in U.S. Dollars by wire transfer or by such other means agreed upon by the parties, in each case at the expense of the payor, for value no later than the due date thereof (with twenty-four 24 hours advance notice of each wire transfer) to the following bank account or such other bank accounts as the payee shall designate in writing within a reasonable period of time prior to such due date:

 

Account Name:

   [*]

Account Number:

   [*]

Bank:

   [*]
   [*]

ABA Number:

   [*]

(c) Taxes . Any federal, state, county or municipal sales or use tax, excise, customs charges, duties or similar charge, or any other tax assessment (other than that assessed against income), license, fee or other charge lawfully assessed or charged on the manufacture, sale or transportation of Bulk Drug Substance sold pursuant to this Agreement shall be paid by InterMune.

8.6   Non-Standard Equipment or Additional Capacity . If additional non-standard or specialized equipment is required to manufacture Bulk Drug Substance for InterMune, InterMune shall pay the cost of such equipment, subject to InterMune’s prior approval of such costs [*] Abbott shall advise InterMune of specialized equipment required and the estimated cost(s) associated with the purchase, installation and validation of such specialized equipment. As of the Effective Date, Abbott represents and warrants that there is no such specialized equipment required for [*] of Development. Such specialized equipment shall be used exclusively for manufacturing of Bulk Drug Substance hereunder or, if utilized for other products, such cost(s) shall be prorated accordingly. Abbott shall bill InterMune for the associated costs [*] . This Section 8.6 shall not apply to any replacement equipment purchased by Abbott because of obsolescense (technical or otherwise). Abbott and InterMune recognize that manufacturing process improvements and projected commercial requirements of Bulk Drug Substance are uncertain. If additional equipment or capacity is required, the parties agree to meet in good faith to discuss the [*] .

 

9. Orders and Forecasts

9.1   First Year Estimate . InterMune shall, within [*] after filing its NDA or its foreign equivalent for Bulk Drug Substance, provide Abbott with a [*] of InterMune’s [*] of Bulk Drug Substance to be supplied by Abbott for the first Contract Year. Abbott acknowledges that such quantities are estimates only and are nonbinding.

9.2   First Order . Abbott and InterMune shall cooperate fully in estimating and scheduling production for the first commercial order of Bulk Drug Substance to be placed by InterMune with Abbott in anticipation of regulatory approval of Bulk Drug Substance.

9.3   First Firm Order . InterMune shall place its first firm order and the required delivery date approximately [*] in advance of the anticipated Bulk Drug Substance regulatory approval date or desired Bulk Drug Substance availability date. The First Order shall be for no less than [*] and no more than [*] of the first estimate as provided in Section 9.1. At the same time, InterMune shall provide to Abbott InterMune’s estimate of its [*] requirements of Bulk Drug Substance to be supplied by Abbott for the next succeeding [*] period.


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9.4   Rolling Forecast . Thereafter, InterMune shall provide quarterly to Abbott a rolling [*] projection of requirements of Bulk Drug Substance to be supplied by Abbott, with the first [*] of such projection consisting of firm purchase orders and the required delivery date and the remaining [*] of such projection consisting of InterMune’s best estimate forecast of its Bulk Drug Substance requirements. Each updated forecast shall be for at least [*] of the most recent forecast for the same quarter and shall not exceed [*] of the most recent forecast for the same quarter. Abbott shall not be obligated to accept a forecast in excess of [*] of the most recent forecast for the same quarter; provided, however, that Abbott shall use its reasonable efforts to accommodate increased needs for Bulk Drug Substance. A failure by Abbott to accommodate such increased needs shall not constitute a breach of this Agreement.

9.5   Purchase Order Acceptance . Within [*] after receipt of InterMune’s firm purchase orders for Bulk Drug Substance, Abbott shall confirm to InterMune its acceptance of the purchase order, delivery date and quantity of Bulk Drug Substance ordered by InterMune.

9.6   Firm Order Changes . If, due to significant unforeseen circumstances, InterMune requests changes to firm orders within the [*] timeframe, Abbott shall attempt to accommodate the changes within reasonable manufacturing capabilities and efficiencies. Abbott shall advise InterMune of the costs that may be associated with making any such change and InterMune shall be deemed to have accepted the obligation to pay Abbott for such costs if InterMune indicates to Abbott that Abbott should proceed to make the change.

9.7   Purchase Order Terms . Each purchase order or any acknowledgment thereof, whether printed, stamped, typed, or written shall be governed by the terms of this Agreement and none of the provisions of such purchase order or acknowledgment shall be applicable except those specifying Bulk Drug Substance and quantity ordered, delivery dates, special shipping instructions and invoice information.

 

10. Proprietary Ownership of Development Work, Preexisting Technology and License Grants

10.1   Existing Proprietary Information . Except as otherwise provided herein, neither party hereto shall be deemed by this Agreement to have been granted any license or other rights to patent rights existing as of the date hereof, or know-how relating to compounds, formulations, or processes which are owned or controlled by the other party.

10.2   Abbott Inventions . With respect to any ideas, innovations or inventions (whether or not patentable) developed solely by Abbott during the term of this Agreement and relating to the manufacturing process of Bulk Drug Substance, Abbott shall own all proprietary rights to such ideas, innovations and inventions, and may obtain patent, copyright, and/or other proprietary protection relating to such ideas, innovations and inventions; provided however, that Abbott hereby grants to InterMune a [*] license with the right to grant sublicenses, to the Abbott Know-How, Abbott Confidential Information and Abbott Patent Rights and to any ideas, innovations or inventions developed hereunder [*] for [*] to [*] to manufacturer Bulk Drug Substance [*] hereunder or [*] Such license [*] in [*] to be [*] upon [*] . Such [*] for Section 7.1 only shall be [*] as a [*] of Bulk Drug Substance [*] utilizing such licensed technology solely for the [*] . In the event that Abbott files a patent application on any such ideas, innovations or inventions, then Abbott shall so notify InterMune within thirty (30) days of the filing of such patent application.

Abbott may not use any InterMune Patent Rights, InterMune Know-How or innovations thereto to develop or manufacture bulk drug substance for any other third-party manufacturer other than InterMune during the term of this agreement and its extensions or [*] .

10.3   InterMune Grant of License . During the term of this Agreement, InterMune hereby grants to Abbott a [*] license, with the right to grant sublicenses to satisfy Abbott’s manufacturing obligations


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hereunder, to InterMune’s Confidential Information, InterMune Know-How, InterMune Patent Rights, and other proprietary rights reasonably necessary, solely to perform hereunder, in connection with the research and development work described in Articles 3 and 4 hereof. In the event that Abbott [*] a third party in the manufacture of Bulk Drug Substance, Abbott shall [*] Such third party shall be an Abbott Quality Assurance approved third party and shall have executed a confidentiality agreement that [*] with respect to Confidential Information as set forth in Article 11 below. Any third party contract entered into by [*] shall contain a provision that allows InterMune to audit and approve such third party’s facilities. Abbott warrants that upon the Effective Date, there are no third parties established and that prior to utilization of a third party Abbott shall [*] .

10.4   Joint Inventions . Each party shall own a [*] in all such inventions, discoveries and know-how made, conceived, reduced to practice and/or otherwise generated jointly by at least one employee, agent, or other person acting for each party in the course of this Agreement. The parties shall collaborate on any actions with respect to the protection of their joint rights in such inventions, discoveries and know-how, at shared expense, and thereafter each party may make, use, sell, keep, license, assign, or mortgage such jointly-owned inventions, discoveries and know-how, and otherwise [*] with respect to such inventions, discoveries and know-how, [*] .

 

11. Confidential Information

Neither party shall use or disclose any Confidential Information received by it except as is reasonably necessary to perform the acts contemplated by this Agreement. Notwithstanding the foregoing, if either party is required or believes it necessary to disclose any Confidential Information received by it pursuant to this Agreement (whether by audit or otherwise) to any third party or governmental agency in compliance with any federal, state and/or local laws and/or regulations, such as the United States Securities and Exchange Commission (“SEC”) or pursuant to an order of a court of competent jurisdiction, the disclosing party shall notify the party owning such Confidential Information immediately, prior to any such disclosure, in order to [*] . In any event, the disclosing party shall make any disclosures of Confidential Information received by it pursuant to this Agreement only to the extent required, and only to such persons who have a need to know. The obligations of the parties relating to Confidential Information shall expire [*] after termination of this Agreement.

 

12. Term and Termination

12.1   Term . This Agreement shall become effective as of the Effective Date, and unless sooner terminated hereunder, shall continue in effect until the completion of the [*] Contract Year following the Launch Date (the initial term); provided, however, that [*] prior written notice of a party’s intent to terminate this Agreement is given to the other party. THEREAFTER, THIS AGREEMENT SHALL STAY IN EFFECT FOR RECURRENT ADDITIONAL TWO (2) YEAR PERIODS UNLESS EIGHTEEN (18) MONTHS PRIOR WRITTEN NOTICE OF A PARTY’S INTENT TO TERMINATE IS GIVEN TO THE OTHER PARTY.

12.2   Termination Rights [*] may terminate the Project upon [*] prior written notice to the other party if [*] in good faith that the [*] before or after the [*] is [*] or if it [*] If the Project is so terminated, Abbott shall advise InterMune of Abbott’s research and development fees on the Project incurred prior to such termination. The parties shall [*] Such fees shall not exceed [*] had the project not been terminated. Abbott, if requested by InterMune, shall provide to InterMune a summary of fees payable pursuant to this Section 12.2. Upon payment of any adjustment required by this Section 12.2, this Agreement shall terminate.

12.3   InterMune Termination Rights . In the event InterMune elects not to launch Bulk Drug Substance by [*] InterMune shall have the right to terminate this Agreement.


* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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12.4   General Termination Rights . Upon the occurrence of the following events, either party may terminate this Agreement by giving the other party sixty (60) days prior written notice:

(a) Upon the bankruptcy or insolvency of the other party; or

(b) Upon the material breach of any provision of this Agreement by the other party if the breach is not remedied prior to the expiration of such sixty (60) - day notice period, or if the breach is of a type that cannot be remedied within Sixty (60) days then a remedy promptly commenced and diligently pursued until complete remediation.

12.5   Survival Provisions . Termination, expiration, cancellation or abandonment of this Agreement through any means and for any reason shall not relieve the parties of any obligation accruing prior thereto, including, but not limited to, the obligation to pay money, and shall be without prejudice to the rights and remedies of either party with respect to the antecedent breach of any of the provisions of this Agreement. Further, Articles 10,11, 12, 13, 14, 15, 16, 19, 20 and 24 shall survive the termination of this Agreement.

 

13. Warranties

13.1   InterMune Warranties . InterMune warrants to Abbott that, to the best of InterMune’s knowledge, InterMune Patent Rights, InterMune Know-How, and Confidential Information provided by InterMune to Abbott for use in the research and development work described in this Agreement and for Abbott to manufacture and supply Bulk Drug Substance under this Agreement do not [*] InterMune warrants that it owns or controls all of the rights, title and interest in and to the InterMune Patent Rights, InterMune Know-How, and Confidential Information provided by InterMune to Abbott hereunder, and that it has the full right and authority to grant to Abbott the license described in Section 10.3. InterMune further warrants that [*] to manufacture and supply Bulk Drug Substance for InterMune, its Affiliates, subsidiaries, licensees and sublicensees. INTERMUNE MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO BULK DRUG SUBSTANCE. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, THE IMPLIED WARRANTIES OR MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE HEREBY DISCLAIMED BY INTERMUNE.

13.2   Abbott Warranties . Abbott warrants to InterMune that, to the best of Abbott’s knowledge, Abbott Patent Rights, Abbott Know-How, and Confidential Information provided by Abbott to InterMune for use in the research and development work described in this Agreement and for InterMune to manufacture and supply Bulk Drug Substance under this Agreement do not [*] Abbott warrants that it owns or controls all of the rights, title and interest in and to the Abbott Patent Rights, Abbott Know-How, and Confidential Information provided by Abbott to InterMune hereunder, and that it has the full right and authority to grant to InterMune the license described in Section 10.2. Abbott further warrants that [*] to manufacture and supply Bulk Drug Substance. Abbott also warrants to InterMune that any Bulk Drug Substance delivered to InterMune pursuant to this Agreement shall conform with the Bulk Drug Substance Specifications and shall be in compliance with applicable laws and regulations. Abbott further warrants that as of the effective date this agreement Abbott has no outstanding contracts, assignments or obligations that are inconsistent with the obligations hereunder. ABBOTT MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO BULK DRUG SUBSTANCE. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE HEREBY DISCLAIMED BY ABBOTT.


* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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14. Indemnification

14.1   InterMune Indemnification . InterMune shall defend, indemnify and hold Abbott and its Affiliates and their respective employees, directors and agents harmless against any liability, judgment, demand, action, suit, loss, damage, cost and other expense (including reasonable attorneys’ fees) (“Liability”) [*] negligence or willful act or omission in the development, testing, use, manufacture, promotion, marketing, sale, distribution, packaging, labeling, handling, storage, and/or disposal of Bulk Drug Substance and/or formulations containing Bulk Drug Substance; or (ii) any action brought by a third party alleging infringement of any patent or other proprietary rights of such third party [*] InterMune’s and/or any InterMune’s Affiliate’s, licensee’s and/or sublicensee’s material breach of this Agreement, except to the extent Abbott is liable under Section 14.2.

14.2   Abbott Indemnification . Abbott shall defend, indemnify and hold InterMune, its Affiliates, licensees and sublicensees and their respective employees, directors and agents harmless against any Liability [*] Abbott’s negligence or willful act or omission in the research, development, testing, use, storage, handling, packaging, labeling, manufacture, storage or delivery of Bulk Drug Substance or its raw materials; or (ii) any action brought by a third party alleging infringement of any patent or other proprietary rights of such third party [*] Abbott’s or any Abbott Affiliate licensee’s and or sublicensee’s material breach of this Agreement, except to the extent InterMune is liable under Section 14.1.

14.3   Claims and Proceedings . Each party shall notify the other promptly of any threatened or pending claim or proceeding covered by any of the above Sections in this Article 14 and shall include sufficient information to enable the other party to assess the facts. Each party shall cooperate fully with the other party in the defense of all such claims. No settlement or compromise shall be binding on a party hereto without its prior written consent.

14.4   Limitation of Liability IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES INCLUDING WITHOUT LIMITATION LOST PROFITS OR LOST REVENUE.

 

15. Assignment

Neither party shall assign this Agreement or any part thereof without the prior written consent of the other party, which consent shall not be unreasonably withheld; provided however, this Agreement shall be automatically assigned to an acquiring person or entity upon the acquisition, merger, consolidation of a party, or of the assets or substantially all the assets by such person or entity, relating to such party’s performance hereunder. Any permitted assignee shall assume all obligations of its assignor under this Agreement. No assignment shall relieve any party of responsibility for the performance of any accrued obligation, which such party then has hereunder.


* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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16. Notices

All notices hereunder shall be in writing and shall be delivered personally, registered or certified mail, postage prepaid, mailed by express mail service or given by facsimile, to the following addresses of the respective parties:

 

If to Abbott:

  

Abbott Laboratories

President

Specialty Products Division

Department 390, Building A1

1401 Sheridan Road

North Chicago, IL 60064-4000

Fax Number: 847-938-2315

with copy to:

  

Abbott Laboratories

Senior Vice President and General Counsel

Department 364, Building AP6D

100 Abbott Park Road

Abbott Park, IL 60064-6049

Fax Number: 847-938-6277

If to InterMune:

  

InterMune, Inc.

General Counsel

3280 Bayshore Blvd

Brisbane, CA 94005

Fax Number: 415-508-0006

Notices shall be effective upon receipt if personally delivered, on the third business day following the date of mailing if sent by certified or registered mail, and on the second business day following the date of delivery to the express mail service if sent by express mail, or the date of transmission if sent by facsimile. A party may change its address listed above by notice to the other party.

 

17. Recalls

In the event that (i) any government authority issues a request, directive or order that the Bulk Drug Substance or a formulation containing Bulk Drug Substance be recalled or (ii) a court of competent jurisdiction orders such a recall, or (iii) InterMune determines after consultation with Abbott that the Bulk Drug Substance or formulation containing Bulk Drug Substance should be recalled, the parties shall take all appropriate corrective actions. In the event that such recall results from the failure of Bulk Drug Substance to meet the Bulk Drug Substance Specifications [*] Abbott shall be responsible for all expenses of recall. In all other cases, InterMune shall be responsible for the expense of recall, including the expense or service fee associated with the representative’s time in administering the recall. For purposes of this Agreement, the expenses of recall shall include without limitation the expense of notification and destruction or return of the recalled Bulk Drug Substance or formulation containing Bulk Drug Substance but not the expense or service fee associated with the representative’s time which shall [*] . The remedy set forth above shall constitute the sole remedy under this Article 17.

 

18. Entire Agreement

This Agreement constitutes the entire agreement between the parties concerning the subject matter hereof and supersedes all written or oral prior agreements or understandings with respect thereto.

 

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19. Alternative Dispute Resolution and Applicable Law

19.1   Choice of Law . This Agreement shall be construed, interpreted and governed by the laws of the State of New York excluding such state’s choice of law provisions.

19.2   Alternative Dispute Resolution . The parties recognize that bona fide disputes may arise which relate to the parties’ rights and obligations under this Agreement. The parties agree that any such dispute shall be resolved by Alternative Dispute Resolution (“ADR”) in accordance with the procedure set forth in Exhibit E .

 

20. Force Majeure

Any delay in the performance of any of the duties or obligations of any party (except the payment of money due hereunder) caused by an event outside the affected party’s reasonable control shall not be considered a breach of this Agreement, and unless provided to the contrary herein, the time required for performance shall be extended for a period equal to the period of such delay. Such events shall include without limitation, acts of God; acts of the public enemy; insurrections; riots; injunctions; embargoes; labor disputes, including strikes, lockouts, job actions, or boycotts; fires; explosions; floods; earthquakes; shortages of material or energy; delays in the delivery of raw materials, or other unforeseeable causes beyond the reasonable control and without the fault or negligence of the party so affected. The party so affected shall give prompt notice to the other party of such cause, and shall take whatever reasonable steps are necessary to relieve the effect of such cause as rapidly as reasonably possible.

 

21. Severability

If any term or provision of this Agreement shall for any reason be held invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other term or provision hereof, and this Agreement shall be interpreted and construed as if such term or provision, to the extent the same shall have been held to be invalid, illegal or unenforceable, had never been contained herein.

 

22. Waiver

No waiver or modification of any of the terms of this Agreement shall be valid unless in writing and signed by an authorized representative of each party hereto. Failure by either party to enforce any rights under this Agreement shall not be construed as a waiver of such rights, nor shall a waiver by either party in one or more instances be construed as constituting a continuing waiver or as a waiver in other instances.

 

23. Exhibits

All Exhibits referenced herein are hereby made a part of this Agreement.

 

24. Counterparts

This Agreement may be executed in any number of separate counterparts, each of which shall be deemed to be an original, but which together shall constitute one and the same instrument.

 

25. No Publicity

Neither party shall disclose the material provisions (as defined in the next sentence) of this Agreement without the prior written approval of the other party. For purposes of this Section, the term “material provisions” shall include price, term, termination options and ownership of intellectual

 

14


property. Neither party shall use the name of the other party in any publicity release or advertising without the other party’s prior written consent. Neither party shall make any public announcement or public statement concerning the material provisions of this Agreement, except as may be required by law or judicial order, without the written consent of the other party. Any such disclosure required by law or judicial order proposed by a party that names the other party, shall first be provided in draft to the other party. Each party shall use [*] efforts to provide the other party with [*] to review any such proposed draft.

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their duly authorized representatives on the later day and year written below.

 

ABBOTT LABORATORIES     INTERMUNE, INC.

By:

  /s/ Charles T. Mitchell     By:   /s/ Peter Van Vlasselaer

Print Name: Charles T. Mitchell

   

Print Name: Peter Van Vlasselaer

Title: GM, Pharma

    Title: Sr. Vice President Technical Ops.

Date: 12/28/01

    Date: 12/14/01

* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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EXHIBIT A

BULK DRUG SUBSTANCE

IM-328-000-000 A Compound Oritavancin

[Graphic: A structural representation of the semi-synthetic glycopeptide antibiotic]


EXHIBIT B

BULK DRUG SUBSTANCE SPECIFICATIONS

 

Analytical Property

  

Limit

[*]

   [*]

[*]

   [*]

[*]

   [*]

[*]

   [*]

[*]

   [*]

[*]

   [*]
[*]   

* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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EXHIBIT C

INTERMUNE, INC.

ABBOTT LABORATORIES

DEVELOPMENT PROPOSAL

CONFIDENTIAL

No use or disclosure outside Abbott is permitted without prior written authorization from Abbott.

 

Stage I

   — Technology Evaluation, Technology Transfer, and Laboratory Demonstration

Stage II

   — Establish CMCs and Execute Pilot Scale Runs

Stage III

   — Scale up Manufacturing and CMC Activities

 

  Jon C. Best
  Abbott Custom Pharma
  Abbott Laboratories
  November 30, 2001

 

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INTERMUNE ORITAVANCIN API PROPOSAL

STAGE 1 Technology Transfer and Laboratory Demonstration

 

1. [*]

* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

ii


INTERMUNE ORITAVANCIN API PROPOSAL

STAGE 2 Establish CMCs and Execute Pilot Scale Runs and Stability protocol

 

1. [*]

* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

iii


INTERMUNE ORITAVANCIN API PROPOSAL

STAGE 3 Scale-up Manufacturing and CMC (Validation, PJ, etc.) and execute stability protocol

 

1. [*]

* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

iv


INTERMUNE ORITAVANCIN API PROPOSAL

Assumptions:

[*]


* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

v


INTERMUNE ORITAVANCIN API PROPOSAL

 

Dates*

  

Delivered

  

Material

[*]    [*]    [*]

[*]


* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

vi


INTERMUNE ORITAVANCIN API PROPOSAL

Cost Summary:

STAGE 1 Technology Transfer and Laboratory Demonstration

[*]

STAGE 2 Establish CMCs and Execute Pilot Scale Runs

[*]

STAGE 3 Scale-up Manufacturing and CMC (Validation, PJ, etc.)

[*]


* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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InterMune Oritavancin 2002 Annual Payment Schedule

[*]

 

   [*]    [*]    [*]    [*]    [*]    [*]    [*]    [*]    [*]    [ *]   [ *]   [ *]   [ *]
   [*]    [*]    [*]    [*]    [*]    [*]    [*]    [*]    [*]    [ *]   [ *]   [ *]   [ *]

Entire Stage 1 & 2 Analytical

Support for Chem & Ferm

                                   
   [*]    [*]    [*]    [*]    [*]    [*]    [*]    [*]    [*]    [ *]   [ *]   [ *]   [ *]

Chemical Development

Stages 1 & 2

                                   
   [*]    [*]    [*]    [*]    [*]    [*]    [*]    [*]    [*]    [ *]   [ *]   [ *]   [ *]

API Clinical Deliveries

                                   
   [*]    [*]    [*]    [*]    [*]    [*]    [*]    [*]    [*]    [ *]   [ *]   [ *]   [ *]

Fermentation Development

Stage 1 & 2

                                   
   [*]    [*]    [*]    [*]    [*]    [*]    [*]    [*]    [*]    [ *]   [ *]   [ *]   [ *]

Abbott Fermentation Nucleus

 1 / 6 Scale Deliveries

                                   
   [*]    [*]    [*]    [*]    [*]    [*]    [*]    [*]    [*]    [ *]   [ *]   [ *]   [ *]

* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

viii


InterMune Oritavancin 2003 Annual Payment Schedule

[*]

 

   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]
   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]

Stage 3 Analytical

Support for Chem & Ferm

                          
   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]

Chemical Development

Stage 3

                          
   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]

API Full Scale Validation Delivery

                          
   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]

Fermentation Development

Stage 3

                          
   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]

Abbott Fermentation Nucleus

Full Scale Validation Deliveries

                          
   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]   [ *]

* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

ix


[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

Exhibit D

Numerical Price Example

[*]


* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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EXHIBIT E

Alternative Dispute Resolution

The parties recognize that bona fide disputes as to certain matters may arise from time to time during the term of this Agreement which relate to either party’s rights and/or obligations. To have such a dispute resolved by this Alternative Dispute Resolution (“ADR”) provision, a party first must send written notice of the dispute to the other party for attempted resolution by good faith negotiations between their respective presidents (or their designees) of the affected subsidiaries, divisions, or business units within [*] after such notice is received (all references to “days” in this ADR provision are to calendar days).

If the matter has not been resolved within [*] of the notice of dispute, or if the parties fail to meet within such [*] , either party may initiate an ADR proceeding as provided herein. The parties shall have the right to be represented by counsel in such a proceeding.

 

1. To begin an ADR proceeding, a party shall provide written notice to the other party of the issues to be resolved by ADR. Within [*] after its receipt of such notice, the other party may, by written notice to the party initiating the ADR, add additional issues to be resolved within the same ADR.

 

2. Within [*] following receipt of the original ADR notice, the parties shall select a mutually acceptable neutral to preside in the resolution of any disputes in this ADR proceeding. If the parties are unable to agree on a mutually acceptable neutral within such period, either party may request the President of the CPR Institute for Dispute Resolution (“CPR”), 366 Madison Avenue, 14th Floor, New York, New York 10017, to select a neutral pursuant to the following procedures:

(a) The CPR shall submit to the parties a list of not less than [*] candidates within [*] after receipt of the request, along with a Curriculum Vitae for each candidate. No candidate shall be an employee, director, or shareholder of either party or any of their subsidiaries or affiliates.

(b) Such list shall include a statement of disclosure by each candidate of any circumstances likely to affect his or her impartiality.

(c) Each party shall number the candidates in order of preference (with the number one (1) signifying the greatest preference) and shall deliver the list to the CPR within [*] following receipt of the list of candidates. If a party believes a conflict of interest exists regarding any of the candidates, that party shall provide a written explanation of the conflict to the CPR along with its list showing its order of preference for the candidates. Any party failing to return a list of preferences on time shall be deemed to have no order of preference.

(d) If the parties collectively have identified fewer than three (3) candidates deemed to have conflicts, the CPR immediately shall designate as the neutral the candidate for whom the parties collectively have indicated the greatest preference. If a tie should result between two candidates, the CPR may designate either candidate. If the parties collectively have identified three (3) or more candidates deemed to have conflicts, the CPR shall review the explanations regarding conflicts and, in its sole discretion, may either (i) immediately designate as the neutral the candidate for whom the parties collectively have indicated the greatest preference, or (ii) issue a new list of not less than five (5) candidates, in which case the procedures set forth in subparagraphs 2(a)-2(d) shall be repeated.

 

3. No earlier than [*] or later than [*] after selection, the neutral shall hold a hearing to resolve each of the issues identified by the parties. The ADR proceeding shall take place at a location

* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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agreed upon by the parties. If the parties cannot agree, the neutral shall designate a location other than the principal place of business of either party or any of their subsidiaries or affiliates.

 

4. At least [*] prior to the hearing, each party shall submit the following to the other party and the neutral:

(a) a copy of all exhibits on which such party intends to rely in any oral or written presentation to the neutral;

(b) a list of any witnesses such party intends to call at the hearing, and a short summary of the anticipated testimony of each witness;

(c) a proposed ruling on each issue to be resolved, together with a request for a specific damage award or other remedy for each issue. The proposed rulings and remedies shall not contain any recitation of the facts or any legal arguments and shall not exceed [*].

(d) a brief in support of such party’s proposed rulings and remedies, provided that the brief shall not exceed [*] . This page limitation shall apply regardless of the number of issues raised in the ADR proceeding.

Except as expressly set forth in subparagraphs 4(a)-4(d), no discovery shall be required or permitted by any means, including depositions, interrogatories, requests for admissions, or production of documents.

 

5. The hearing shall be conducted on [*] consecutive days and shall be governed by the following rules:

(a) Each party shall be entitled to [*] hours of hearing time to present its case. The neutral shall determine whether each party has had the [*] hours to which it is entitled.

(b) Each party shall be entitled, but not required, to make an opening statement, to present regular and rebuttal testimony, documents or other evidence, to cross-examine witnesses, and to make a closing argument. Cross-examination of witnesses shall occur immediately after their direct testimony, and cross-examination time shall be charged against the party conducting the cross-examination.

(c) The party initiating the ADR shall begin the hearing and, if it chooses to make an opening statement, shall address not only issues it raised but also any issues raised by the responding party. The responding party, if it chooses to make an opening statement, also shall address all issues raised in the ADR. Thereafter, the presentation of regular and rebuttal testimony and documents, other evidence, and closing arguments shall proceed in the same sequence.

(d) Except when testifying, witnesses shall be excluded from the hearing until closing arguments.

(e) Settlement negotiations, including any statements made therein, shall not be admissible under any circumstances. Affidavits prepared for purposes of the ADR hearing also shall not be admissible. As to all other matters, the neutral shall have sole discretion regarding the admissibility of any evidence.

 

6. Within [*] following completion of the hearing, each party may submit to the other party and the neutral a post-hearing brief in support of its proposed rulings and remedies, provided that such brief shall not contain or discuss any new evidence and shall not exceed [*] This page limitation shall apply regardless of the number of issues raised in the ADR proceeding.

 

7. The neutral shall rule on each disputed issue within [*] following completion of the hearing. [*] .

 

8. The neutral shall be paid a reasonable fee plus expenses. These fees and expenses, along with the reasonable legal fees and expenses of the prevailing party (including all expert witness fees and

* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

ii


 

expenses), the fees and expenses of a court reporter, and any expenses for a hearing room, shall be paid as follows:

(a) If the neutral rules in favor of one party on all disputed issues in the ADR, the losing party shall pay 100% of such fees and expenses.

(b) If the neutral rules in favor of one party on some issues and the other party on other issues, the neutral shall issue with the rulings a written determination as to how such fees and expenses shall be allocated between the parties. The neutral shall allocate fees and expenses in a way that bears a reasonable relationship to the outcome of the ADR, with the party prevailing on more issues, or on issues of greater value or gravity, recovering a relatively larger share of its legal fees and expenses.

 

9. The rulings of the neutral and the allocation of fees and expenses shall be binding, non-reviewable, and non-appealable, and may be entered as a final judgment in any court having jurisdiction.

 

10. Except as provided in paragraph 9 or as required by law, the existence of the dispute, any settlement negotiations, the ADR hearing, any submissions (including exhibits, testimony, proposed rulings, and briefs), and the rulings shall be deemed Confidential Information. The neutral shall have the authority to impose sanctions for unauthorized disclosure of Confidential Information.

 

11. All disputes referred to ADR, the statute of limitations, and the remedies for any wrong that may be found, shall be governed by the laws of the State of Illinois.

 

12. The neutral may not award punitive damages. The parties hereby waive the right to punitive damages.

 

13. The hearings shall be conducted in the English language.

 

iii

EXHIBIT 10.16.1

[*] = CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

AMENDMENT NUMBER 1

To the Development and Supply Agreement dated December 28, 2001 (the Agreement) between Abbott Laboratories (“Abbott”) and InterMune, Inc. (“InterMune”).

Abbott and InterMune agree to amend the Agreement as follows:

1. The parties agree to amend the scope of the project as set forth in Exhibit C of the Agreement. Exhibit C of the Agreement shall be amended to include the work set forth on Attachment A hereto.

2. Section 5.1(b) is deleted in its entirety and replaced with the following:

The remainder of the Fee will be invoiced and paid according to the annual payment schedule in Exhibit C . [*] installments of the Research and Development Fee shall be paid within [*] of the receipt of each [*] Abbott invoice for the amount due. Invoices shall precede, [*] from the previous [*] .

3. Section 8.3(b) is deleted in its entirety and replaced with the following:

Quality Assurance.  Within [*] after the date of the signing of this Agreement, representatives of the parties’ Quality Assurance departments shall meet to develop and approve a quality agreement (“Quality Agreement”) outlining the responsibilities and key contacts for quality and compliance related issues. Items to be included in the Quality Agreement include, but are not limited to recalls, annual product reviews, returned goods, regulatory audits, compliance with cGMP, compliance with such other quality related concerns deemed appropriate.

Capitalized terms used herein and not otherwise defined shall have the same meaning as under the Agreement.


* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.


Except as specifically set forth above, all other terms and conditions of the Agreement shall remain in full force and effect.

 

INTERMUNE, INC.     ABBOTT LABORATORIES
By:   /s/ PETER VAN VLASSELAER     By:   /s/ CHARLES T. MITCHELL
  Peter Van Vlasselaer       Charles T. Mitchell
Title:   Sr. VP. Tech Ops     Title:   GM, Pharma
Date:   4/26/02     Date:   April 25, 2002


Attachment A

ADDITIONAL ACTIVITIES AND FEES

Scope Change 2A:

Characterization of Lilly Strain A82846-UV37-B

[*]


* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

Exhibit 10.16.2

[*] = CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

AMENDMENT NUMBER 2

To the Development and Supply Agreement dated December 28, 2001 (the Agreement) between Abbott Laboratories (“Abbott”) and InterMune, Inc. (“InterMune”), collectively the (“Parties”).

Abbott and InterMune agree to amend the Agreement as follows:

1. Section 5 shall be amended as follows: (Terms and conditions detailed in 5.1 (a) and (b) remain unchanged. The payment schedule in Exhibit C shall be replaced with Attachment A.)

5.1 Research and Development Fee . To reimburse Abbott for its participation in the Project, InterMune shall pay Abbott a [*] research and development fee of [*]. The research and development fee (“Fee”) shall be paid to Abbott as follows:

2. Section 6.1 of the Agreement is amended as follows:

6.1 Pilot Scale/Clinical Supplies . Abbott shall provide to InterMune pilot/clinical scale supplies consisting of approximately [*] of Bulk Drug Substance, [*] Abbott. Such pilot scale lots shall yield Abbott’s best efforts, [*] per lot and shall meet the Bulk Drug Substance specifications as mutually agreed to by the Parties.

3. Section 6.2 of the Agreement shall be amended as follows:

6.2 Validation Supplies . Abbott shall provide to InterMune validation supplies consisting of [*] of Bulk Drug Substance totaling [*], or as mutually agreed to by the parties to satisfy the InterMune regulatory strategy. Such batch lots shall meet the mutually defined Bulk Drug Substance specifications. InterMune shall notify Abbott of any alteration of the validation schedule and Bulk Drug Substance amount.

4. In accordance with Section 6.3 and Exhibit C, a revised delivery and payment schedule has been agreed to by the Parties and is attached hereto as Attachment A.

5. The Parties agree to amend the scope of the Project as set forth in Exhibit C of the Agreement. Exhibit C of the Agreement shall be amended to include the work set forth on Attachment B hereto.

Capitalized terms used herein and not otherwise defined shall have the same meaning as under the Agreement.

Except as specifically set forth above, all other terms and conditions of the Agreement shall remain in full force and effect.

 

INTERMUNE, INC.     ABBOTT LABORATORIES
By:   /s/ Peter Van Vlasselaer     By:   /s/ James Burnett
Title:   Sr. VP Tech. Ops     Title:   Sr. VP - SPD
Date:   9/30/02     Date:   10/15/02

* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

1


Attachment A.

InterMune Oritavancin 2002 Annual Payment Schedule

[*]

[*]


* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

2


Attachment A. (cont.)

InterMune Oritavancin 2003 Annual Payment Schedule

[*]

[*]


* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

3


Attachment B

 

Scope Change #4 Summary   September 19, 2002
[*]  

* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

4

Exhibit 10.16.3

AMENDMENT NUMBER 3

TO

DEVELOPMENT AND SUPPLY AGREEMENT DATED DECEMBER 28, 2001

BETWEEN

ABBOTT LABORATORIES AND INTERMUNE, INC.

This Amendment No. 3, to the Development and Supply Agreement dated as of December 28, 2001, as amended by Amendment No. 1 dated April 26, 2002, Amendment No. 2 dated October 15, 2002, and the letter agreement regarding “Authorization for Disclosure of Confidential Information” dated July 18, 2003 (collectively, the “Agreement”), is effective as of December 22, 2005 (“Amendment No. 3 Effective Date”) between Abbott Laboratories, an Illinois corporation (“Abbott”), and InterMune, Inc., a Delaware corporation (“InterMune”). Any capitalized term used and not otherwise defined herein shall have the meaning set forth in the Agreement.

WHEREAS, the parties desire to amend the Agreement as set forth below.

NOW, THEREFORE, in consideration of the premises and the mutual covenants and agreements contained herein, the parties hereto, intending to be legally bound, hereby agree as follows:

 

  1. Amendment . Abbott and InterMune hereby amend the Agreement as follows:

 

  A. Section 8.6 of the Agreement is amended and restated as follows:

8.6 Non-Standard Equipment or Additional Capacity . If equipment is required to manufacture Bulk Drug Substance for InterMune, InterMune shall pay the cost of such equipment, subject to InterMune’s prior approval of such costs, which approval shall not be unreasonably withheld. Abbott shall advise InterMune of equipment required and the estimated cost(s) associated with the purchase, installation and validation of such equipment. Such equipment shall be used exclusively for manufacturing Bulk Drug Substance hereunder or, if utilized for other products, such cost(s) shall be prorated accordingly. Abbott shall bill InterMune for the associated costs after Abbott installs the equipment.

 

  B. Section 12.1 of the Agreement is amended and restated as follows:

12.1 Term . This Agreement shall become effective as of the Effective Date, and unless sooner terminated hereunder, shall continue in effect until December 31, 2014; provided, however, that twenty-four (24) months prior written notice of a party’s intent to terminate this Agreement is given to the other party. THEREAFTER, THIS AGREEMENT SHALL STAY IN EFFECT FOR RECURRENT ADDITIONAL TWO (2) YEAR PERIODS, UNLESS TWELVE (12) MONTHS PRIOR WRITTEN NOTICE OF A PARTY’S INTENT TO TERMINATE IS GIVEN TO THE OTHER PARTY .


  C. A new Section 12.6 of the Agreement is hereby added to the Agreement and shall read as follows:

12.6 Abbott Termination of Rights . In the event InterMune fails to obtain NDA approval by January 1, 2010, Abbott shall have the right to terminate this Agreement.

 

  D. A new Section 12.7 of the Agreement is hereby added to the Agreement and shall read as follows:

12.6 Actions on Termination .

 

  (a) Upon expiration or termination of this Agreement for any reason by InterMune, upon InterMune’s request, Abbott will reasonably assist InterMune with the technology transfer of the manufacturing process associated with Bulk Drug Substance to InterMune or its designee, and InterMune shall pay Abbott’s reasonable costs and expenses for such assistance.

 

  (b) Upon termination of this Agreement for any reason by Abbott, upon InterMune’s request, Abbott will reasonably assist InterMune with the technology transfer of the manufacturing process associated with Bulk Drug Substance to InterMune or its designee, and Abbott shall pay Abbott’s reasonable costs and expenses for such assistance.

 

  2. Miscellaneous .

 

  A. All terms and conditions set forth in the Agreement that are not amended hereby shall remain in full force and effect.

 

  B. This Amendment shall be governed by and construed in accordance with the substantive law of the State of New York, without regard to the conflicts of law provisions thereof’, and any dispute arising out of or in connection with this Amendment shall be governed by the alternative dispute resolution provisions of Exhibit E of the Agreement.

 

  C. This Amendment may be executed in counterparts, each of which shall be deemed an original, but all of which will constitute one and the same instrument.

 

  D. Any term of this Amendment may be amended with the written consent of both parties.

 

  E. This Amendment is the product of both of the parties hereto, and together with the Agreement constitutes the entire agreement between such parties pertaining to the subject matter hereof, and merges all prior negotiations and drafts of the parties with regard to the matters set forth herein.

 

  F. From the date hereof, any reference to the Agreement shall be deemed to refer to the Agreement as amended by this Amendment.

 

2


IN WITNESS WHEREOF, the parties, through their authorized officers, have executed this Amendment as of the Amendment No. 3 Effective Date.

 

INTERMUNE, INC.     ABBOTT LABORATORIES
/s/ Tom Kassberg     /s/ Mike L. McGibbon
Name: Tom Kassberg     Name: Mike L. McGibbon
Title: Sr. VP Business Development     Title: General Manager, Pharma
Dated: December 16, 2005     Dated: December 20, 2005

 

3

Exhibit 10.16.4

[*] = CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

AMENDMENT NUMBER 4 TO THE

DEVELOPMENT AND SUPPLY AGREEMENT DATED DECEMBER 28, 2001

BETWEEN

ABBOTT LABORATORIES AND INTERMUNE, INC. (TARGANTA

THERAPEUTICS)

This Fourth Amendment, to the Development and Supply Agreement dated as of December 28, 2001, as amended by Amendment Number 1 dated April 26, 2002, Amendment Number 2 dated October 15, 2002, and Amendment Number 3 dated December 22, 2005 (the “Agreement”), is effective as of December 15, 2006 (“Amendment Effective Date”), between Abbott Laboratories, an Illinois corporation (“Abbott”), and Targanta Therapeutics Corporation, an Indianapolis, Indiana corporation (“Targanta”) as purchaser of all rights title and interest related to Oritavancin from InterMune, Inc., a Delaware corporation (“InterMune”). Any capitalized term used and not otherwise defined herein shall have the meaning set forth in the Agreement.

WHEREAS, the parties desire to amend the Agreement to revise certain provisions relating to the forecasts for the Product and/or Bulk Drug Substance;

WHEREAS, InterMune sold to Targanta and Targanta purchased from InterMune all rights, title and interest in Oritavancin, including, without limitation, the contractual rights and obligations contained in the Agreement and this Agreement was automatically assigned to Targanta in accordance with Section 15 of the Agreement.

NOW, THEREFORE, in consideration of the premises and the mutual covenants and agreements contained herein, the parties hereto, intending to be legally bound, hereby agree as follows:

 

  1. Amendment . Abbott and Targanta hereby amend the Agreement as follows:

 

  A. All reference to InterMune or InterMune, Inc. shall be deleted and replaced with Targanta Therapeutics (“Targanta”), as applicable (excluding the reference to InterMune contained in Section 5.1 and 6.2 hereof) and Targanta agrees to be bound by and assume all rights, obligations and liabilities as set forth in the Agreement and all references to “party” or “parties” shall refer to Abbott, Targanta and/or both, as may be applicable.

 

  B. Exhibit C of the Agreement shall be modified to include a Stage 4 development program for [*] and manufacture of three cGMP batches of Bulk Drug Substance (“Stage 4 Project”).

 

  1. The Stage 4 Project attached hereto as Attachment 1 shall be added to Exhibit C of the Agreement.

* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.


  C. Section 5.1 of the Agreement shall be deleted in its entirety and replaced with the following:

Research and Development Fee . The parties acknowledge and agree that Abbott has been paid in full for its participation in the Project for Stages 1 – 3 of the Project. The parties further agree that to reimburse Abbott for its participation in the Stage 4 Project, Targanta shall pay Abbott a [ * ] research and development fee [ * ] (the “Fee”). The Fee shall be paid on a [ * ] basis as broken down in the Payment Schedule Forecast set forth in Exhibit C and is mutually exclusive and in addition to the research and development fee already paid by InterMune for the completion of Stages 1, 2, and 3. Invoices shall be sent to Targanta on a [ * ] basis and payment for the applicable Fee for that period shall be made within [ * ] of receipt of each applicable invoice. If milestones in the Stage 4 Project are reached earlier than forecasted, the Stage 4 Project will move to the next area of focus with a commensurate reduction in the forecasted fees, if applicable, and any such adjusted fee shall be set forth in writing.

 

  D. Section 6.2 of the Agreement shall be deleted and replaced with the following:

Validation Supplies . Abbott has provided to InterMune validation supplies consisting of [ * ] of Bulk Drug Substance. As a component of the development activities described in the Stage 4 Project set forth in Exhibit C, Abbott shall supply to Targanta [ * ] of Bulk Drug Substance for clinical, regulatory, and/or commercial use. The [ * ] shall target [ * ] of Bulk Drug Substance and incorporate [*] defined in the Stage 4 Project.

 

  E. Section 8.3(b) of the Agreement shall be deleted and replaced with the following:

Quality Assurance . Within [ * ] following the signing of this amendment, representatives of the parties’ Quality Assurance departments shall meet to develop and approve a quality agreement (“Quality Agreement”) outlining the responsibilities and key contacts for quality and compliance related issues. Items to be included in the Quality Agreement include, but are not limited to, recalls, annual product reviews, returned goods, regulatory audits, compliance with cGMP, and compliance with such other quality related concerns deemed appropriate.

 

  F. Section 8.5(b) (Abbott Bank Information only) of the Agreement shall be deleted and replaced with the following: Account Name:

 

Account Name:

   [*]

Account Number:

   [ * ]

Bank:

   [ * ]

ABA Number: [ * ]

   [ * ]

* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

2


  G. Section 8.6 of the Agreement is modified to add the following information to the end of the paragraph:

The parties acknowledge and agree that equipment modifications are necessary for the Stage 4 Project and for continued commercial production of Bulk Drug Substance thereafter. The parties acknowledge that equipment modifications are estimated to be approximately [ * ], but are subject to change, and shall be billed by Abbott to Targanta at Abbott’s cost, as the aforementioned equipment modifications occur. Notwithstanding the foregoing, in the event the equipment modifications are anticipated to [ * ] (the “Maximum Equipment Fee”), Abbott shall obtain Targanta’s prior written approval of the costs in excess of the Maximum Equipment Fee before commencing such equipment modifications.

 

  H. Section 12.3 of the Agreement is deleted in its entirety.

 

  I. Section 12.7(a) is modified to read as follows:

Upon expiration or termination of this Agreement for any reason by Targanta, upon Targanta’s request, Abbott will reasonably assist Targanta with the technology transfer of the manufacturing process associated with Bulk Drug Substance to Targanta or its designee, and Targanta [*].

 

  J. Section 12.7(b) is modified to read as follows:

Upon termination of this Agreement for any reason by Abbott (excluding for Targanta’s uncured breach), upon Targanta’s request, Abbott will reasonably assist Targanta with the technology transfer of the manufacturing process associated with Bulk Drug Substance to Targanta or its designee, and Abbott [*].

 

  K. Add Section 12.7(c) to the agreement to read as follows:

Upon expiration or termination of this Agreement by Abbott for Targanta’s uncured breach of this Agreement, upon Targanta’s request and upon Targanta’s payment of (i) any payments due to Abbott for services rendered or Bulk Drug Substance provided under the Agreement prior to termination and (ii) Abbott’s reasonable costs and expenses for Abbott’s assistance of Targanta with the technology transfer of the manufacturing process associated with Bulk Drug Substance to Targanta or its designee, Abbott will reasonably assist Targanta with such technology transfer.


* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

3


  L. Section 16 is modified to update the contact information as follows:

 

If to Abbott:

  

Abbott Laboratories

President

Globe Pharmaceutical Manufacturing

Department 390, Building A1

1401 Sheridan Road

North Chicago, IL 60064-4000

Facsimile: 847-938-2315

with copy to:

  

Abbott Laboratories

100 Abbott Park Road

Building AP6A-2, Dept. 323

Abbott Park, Illinois 60064-6011

Attn: Associate General Counsel, Pharmaceutical

Product Group Legal Operations

Facsimile: 847-938-1342

If to Targanta:

  

Targanta Therapeutics

Vice President, Operations and Manufacturing

225 South East Street, Suite 390

Indianapolis, IN 46202

Facsimile: 317-536-7737

 

  2. Miscellaneous .

 

  A. All terms and conditions set forth in the Agreement that are not amended hereby shall remain in full force and effect.

 

  B. This Amendment shall be governed by and construed in accordance with the substantive law of the State of New York, without regard to the conflicts of law provisions thereof, and any dispute arising out of or in connection with this Amendment shall be governed by the alternative dispute resolution provisions set forth in Exhibit E of the Agreement.

 

  C. This Amendment may be executed in counterparts, each of which shall be deemed an original, but all of which will constitute one and the same instrument.

 

  D. Any term of this Amendment may be amended with the written consent of both parties.

 

  E. This Amendment is the product of both of the parties hereto, and together with the Agreement constitutes the entire agreement between such parties pertaining to the subject matter hereof, and merges all prior negotiations and drafts of the parties with regard to the transactions contemplated herein.

 

  F. From the date hereof, any reference to the Agreement shall be deemed to refer to the Agreement as amended by this Amendment.

 

4


IN WITNESS WHEREOF, the parties, through their authorized officers, have executed this Amendment as of the Amendment Effective Date.

 

TARGANTA CORPORATION     ABBOTT LABORATORIES
Signature:   /s/ PIERRE ETIENNE     Signature:   /s/ MIKE L. MCGIBBON
Name:   Pierre Etienne, M.D.     Name:   Mike L. McGibbon
Title:   Chief Development Officer     Title:   G.M., Commercial Ops.

 

5


Attachment 1

Exhibit C - Stage 4

STAGE 4 ORITAVANCIN [*]

ASM FREE, PROCESS DEMONSTRATION &

COMMERCIAL MANUFACTURING

CONFIDENTIAL

No use or disclosure outside Abbott is permitted without prior written authorization from Abbott.

Stage 4 Project

 

Step 1

  

[*]

Step 2

   Nucleus Demonstration at Commercial Scale

Step 3

   Commercial Scale Validation Manufacturing

* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

6


Exhibit C - Stage 4

TARGANTA DEVELOPMENT PROPOSAL

[ * ]


* Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

7

Exhibit 23.2

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

We consent to the reference to our firm under the captions “Selected Consolidated Financial Data” and “Experts” and to the use of our report dated April 20, 2007, except as to Note 19.A as to which the date is May 8, 2007 and Note 2.A as to which the date is June 22, 2007, in Amendment No.1 to the Registration Statement (Form S-1 No. 333-142842) and related Prospectus of Targanta Therapeutics Corporation dated June 27, 2007.

/s/    Ernst & Young LLP

Chartered Accountants

Montréal, Canada

June 22, 2007