-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, BjJzL4R3pl1rujm6ZxwTtjmI9W61Jns1qfMuIzYAlPBoMehBR95d/3+FcEltBTMK JwlmOMVxWgy1xgaSjLQmBg== 0001104659-08-061943.txt : 20081003 0001104659-08-061943.hdr.sgml : 20081003 20081003171656 ACCESSION NUMBER: 0001104659-08-061943 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 11 CONFORMED PERIOD OF REPORT: 20080929 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing ITEM INFORMATION: Unregistered Sales of Equity Securities ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20081003 DATE AS OF CHANGE: 20081003 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Advanced Life Sciences Holdings, Inc. CENTRAL INDEX KEY: 0001322734 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 300296543 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-51436 FILM NUMBER: 081107457 BUSINESS ADDRESS: BUSINESS PHONE: (630) 739-6744 MAIL ADDRESS: STREET 1: 1440 DAVEY ROAD CITY: WOODRIDGE STATE: IL ZIP: 60517 8-K 1 a08-24714_18k.htm 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported):  September 29, 2008

 

ADVANCED LIFE SCIENCES HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

 

000-51436

 

30-0296543

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

 

 

 

 

1440 Davey Road
Woodridge, Illinois

 

60517

(Address of principal executive offices)

 

(Zip Code)

 

(630) 739-6744

(Registrant’s telephone number, including area code)

 

N/A

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

o    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 



 

Item 1.01. 

Entry into a Material Definitive Agreement.

 

Entrance into Development and Commercialization Agreement with Wyeth

 

On September 29, 2008, Advanced Life Sciences Holdings, Inc. (the “Company”) and Wyeth Pharmaceuticals, a division of Wyeth (“Wyeth”), entered into a development and commercialization agreement for cethromycin in the Asia Pacific region excluding Japan. Cethromycin is a novel once-a-day oral antibiotic for the treatment of community respiratory tract infections. The Company will retain exclusive rights to cethromycin in the rest of the world, including North America and Europe and excluding Japan.

 

Under the terms of the agreement, Wyeth made an up-front equity investment in the Company through the purchase of common stock representing approximately 4.9% of the Company’s total outstanding shares. In addition to future royalty payments, the Company would receive milestone and regulatory payments based on successful achievement of clinical, regulatory and commercial objectives in specific markets. The Company and Wyeth will collaborate to develop additional clinical data in the Asia Pacific region to support regulatory filings in that region.  It is not anticipated that Wyeth would file for regulatory approval in the Asia Pacific region prior to the Company obtaining U.S. approval for cethromycin from the FDA.

 

Wyeth’s equity investment in the Company was made pursuant to a Stock Purchase Agreement between the parties, which is discussed further in Item 3.02 below.

 

2



 

A copy of the press release dated October 1, 2008 announcing entry into this transaction is attached hereto as Exhibit 99.1.

 

Commitment Letter with Leaders Bank

 

On September 29, 2008, the Company received a commitment letter offering to increase availability under its existing loan facility with The Leaders Bank from $4 million to $10 million. The commitment provides that the loan would mature on January 1, 2011 and contain substantially similar terms and conditions as the existing loan agreement between the Company and The Leaders Bank.  In addition, (i) all borrowings under the increased line would bear interest at a fixed rate of 8.5%, (ii) the loan would be secured by substantially all the business assets of the Company, and (iii) all principal of the loan would be due upon maturity, with interest only payments due monthly.  Finally, the proposed terms include a covenant limiting the use of the SEDA (as defined and described immediately below in this Item) to $9,000,000 without the bank’s consent.  Consummation of the increased loan facility is subject to entering into definitive agreements and other customary closing conditions.  The commitment expires October 31, 2008.

 

The Company has also agreed to issue to Leaders as a closing fee warrants for the purchase of 65,000 shares of its common stock at an exercise price of $1 per share.

 

A copy of the Commitment Letter is attached hereto as Exhibit 10.1 and incorporated by reference herein.

 

Entrance into Standby Equity Distribution Agreement with YA Global Investments, L.P.

 

On September 29, 2008, the Company entered into a Standby Equity Distribution Agreement (the “SEDA”), a copy of which is attached hereto as Exhibit 4.1, with YA Global Investments, L.P. (“YA”), an affiliate of Yorkville Advisors, for the sale of up to $15,000,000 of shares of the Company’s common stock over a two year commitment period.   In connection with entering into the SEDA, the Company also entered into a Registration Rights Agreement with YA, a copy of which is attached hereto as Exhibit 4.2.

 

Under the terms of the SEDA, the Company may from time to time, in its discretion, sell newly-issued shares of its common stock to YA at a discount to market of 5%. The amount of each advance is generally limited to $400,000 in any weekly period.  The Company is not obligated to utilize any of the $15 million available under the SEDA and there are no minimum commitments or minimum use penalties.

 

Based upon the Company’s currently outstanding shares of common stock, and options and warrants to purchase common stock, the aggregate number of shares that the Company may sell under the SEDA without stockholder approval is currently limited to approximately 5.3 million shares. Unless stockholder approval is sought and obtained, the total amount of funds that ultimately can be raised under the SEDA over the two-year term will depend on the then-current price for the Company’s stock and the number of shares actually sold.  The Company’s proposed amendment to their credit facility with The Leaders Bank discussed above will also contain a covenant limiting the Company’s utilization of the SEDA to $9 million without the bank’s  prior consent.

 

The SEDA does not impose any restrictions on the Company’s operating activities. During the term of the SEDA, YA is prohibited from engaging in any short selling or derivative transactions related to the Company’s common stock. Pursuant to the Registration Rights Agreement, the Company also agreed to file with the Securities and Exchange Commission a registration statement, the effectiveness of which is a condition precedent to the purchase and sale of any shares of common stock under the SEDA.

 

Pursuant to the terms of the SEDA, the Company paid to YA a commitment fee of $300,000 by issuing 393,339 shares of the Company’s common stock.

 

A copy of the Standby Equity Distribution Agreement and the Registration Rights Agreement are attached hereto as Exhibit 4.1 and 4.2, respectively, and each is incorporated by reference herein.

 

Item 3.01. 

Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.

 

Receipt of Notice of Delisting from NASDAQ.

 

On October 1, 2008, the Company received notice from the Nasdaq Listing Qualifications Department stating that the market value of its listed securities was below $35 million for 10 consecutive days, and that it was in violation of the requirement for continued listing on the Nasdaq Capital Market under Marketplace Rule 4310(c)(3)(B).  Nasdaq also informed the Company that it is not in compliance with either of Marketplace Rules 4310(c)(3)(A) or 4310(c)(3)(C), which together require either minimum stockholders’ equity of $2,500,000 or net income from continuing operations of $500,000 in the most recently completed fiscal year or in two of the last three most recently completed fiscal years for listing eligibility.

 

The Company has been provided 30 calendar days, or until October 31, 2008, to establish compliance with these continued listing requirements of the Nasdaq Capital Market.  This would require at a minimum that the market value of listed securities of the Company’s common stock remained above $35 million for a minimum of 10 consecutive business days at anytime prior to October 31, 2008.

 

In the event that the Company does not regain compliance by October 31, 2008, the Company will have the right to appeal a

 

 

3



 

determination to delist its securities from the Nasdaq Capital Market.  The Company’s securities would remain listed on the Nasdaq Capital Market throughout the appeal process.

 

A copy of the press release dated October 3, 2008 announcing receipt of the Nasdaq staff letter is attached hereto as Exhibit 99.2.

 

Item 3.02. 

Unregistered Sales of Equity Securities.

 

Issuance of Commitment Fee Shares Under the Standby Equity Distribution Agreement with YA

 

As noted in Item 1.01 above, in connection with the Company’s entry into the SEDA it paid to YA a commitment fee of $300,000 by issuing 393,339 shares of the Company’s common stock, which have not been registered under the Securities Act of 1933 (the “Securities Act”).  It is contemplated that future sales of the Company’s common stock under the SEDA will be made pursuant to an effective registration statement.

 

The shares of common stock issued in this private placement have not been registered under the Securities Act or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission or an applicable exemption from the registration requirements. The Company relied on the exemption from the registration requirements of the Securities Act provided by Section 4(2) thereof and the rules and regulations promulgated thereunder. The private placement was made without general solicitation or advertising. The shares of common stock were offered and sold only to a purchaser that is an “accredited investor” as such term is defined in Rule 501 under the Securities Act.

 

Entrance into Stock Purchase Agreement with Wyeth

 

As noted in Item 1.01 above, in connection with the Company’s entry into the Development and Commercialization Agreement, the Company entered into a Stock Purchase Agreement dated as of September 29, 2008 with Wyeth, in the form attached hereto as Exhibit 4.3.  Pursuant to the Stock Purchase Agreement, Wyeth purchased 1,888,606 shares of the Company’s Common Stock, par value $0.01 per share, for $1,714,854.25.

 

The shares of common stock issued in the private placement have not been registered under the Securities Act or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission or an applicable exemption from the registration requirements. The Company relied on the exemption from the registration requirements of the Securities Act provided by Section 4(2) thereof and the rules and regulations promulgated thereunder. The private placement was made without general solicitation or advertising. The shares of common stock were offered and sold only to a purchaser that is an “accredited investor” as such term is defined in Rule 501 under the Securities Act.

 

A copy of the Stock Purchase Agreement is attached hereto as Exhibit 4.3 and is incorporated by reference herein.

 

Item 8.01. 

Other Events

 

Submission by the Company of a New Drug Application

 

On September 30, 2008, the Company submitted a new drug application (“NDA”) for its lead product, cethromycin.  The NDA submission is based on a full clinical development and manufacturing program for cethromycin. The program included two global Phase III pivotal studies for the treatment of mild-to-moderate CAP in which cethromycin was dosed at 300 milligrams once daily for seven days compared to the standard of care therapy, Biaxin, which was dosed at 250 milligrams twice daily for seven days. The data from these trials showed that cethromycin was non-inferior to Biaxin with a similar safety profile. The most common adverse reactions for cethromycin were taste disturbance, diarrhea, nausea and headache.  More than 5,000 patients have been treated with cethromycin in 53 clinical trials to date.

 

The Company holds its rights to cethromycin under an exclusive worldwide license (except in Japan) from Abbott Laboratories.  Pursuant to the terms of the Company’s license agreement with Abbott, the submission by the Company of the cethromycin NDA triggers an obligation on the part of the Company to make a milestone payment to Abbott in the amount of $10 million.

 

A copy of the press release dated October 1, 2008 announcing submission of the NDA is attached hereto as Exhibit 99.3.

 

 

4



 

 

Item 9.01.

Financial Statements and Exhibits.

 

(d)           Exhibits:

 

Exhibit No.

 

Description

 

 

 

4.1

 

Standby Equity Distribution Agreement dated as of September 29, 2008 by and between YA Global Investments, L.P. and Advanced Life Sciences Holdings, Inc.

 

 

 

4.2

 

Registration Rights Agreement dated as of September 29, 2008 by and between YA Global Investments, L.P. and Advanced Life Sciences Holdings, Inc.

 

 

 

4.3

 

Stock Purchase Agreement dated as of September 29, 2008 by and between Wyeth and Advanced Life Sciences Holdings, Inc.

 

 

 

10.1

 

Commitment Letter dated as of September 29, 2008 from The Leaders Bank to Advanced Life Sciences Holdings, Inc.

 

 

 

99.1

 

Press Release dated October 1, 2008 relating to the Development and Commercialization Agreement.

 

 

 

99.2

 

Press Release dated October 3, 2008 relating to the Delisting Notice.

 

 

 

99.3

 

Press Release dated October 1, 2008 relating to the submission of the new drug application.

 

 

5



 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

ADVANCED LIFE SCIENCES HOLDINGS, INC.

 

 

 

 

 

 

Dated: October 3, 2008

By:

/s/ Michael T. Flavin

 

Name:

Michael T. Flavin, Ph.D.

 

Title:

Chairman and Chief Executive Officer

 

 

6



 

EXHIBIT INDEX

 

Exhibit No.

 

Description

4.1

 

Standby Equity Distribution Agreement dated as of September 29, 2008 by and between YA Global Investments, L.P. and Advanced Life Sciences Holdings, Inc.

 

 

 

4.2

 

Registration Rights Agreement dated as of September 29, 2008 by and between YA Global Investments, L.P. and Advanced Life Sciences Holdings, Inc.

 

 

 

4.3

 

Stock Purchase Agreement dated as of September 29, 2008 by and between Wyeth and Advanced Life Sciences Holdings, Inc.

 

 

 

10.1

 

Commitment Letter dated as of September 29, 2008 from The Leaders Bank to Advanced Life Sciences Holdings, Inc.

 

 

 

99.1

 

Press Release dated October 1, 2008 relating to the Development and Commercialization Agreement.

 

 

 

99.2

 

Press Release dated October 3, 2008 relating to the Delisting Notice.

 

 

 

99.3

 

Press Release dated October 1, 2008 relating to the submission of the new drug application.

 

 

7


 

EX-4.1 2 a08-24714_1ex4d1.htm EX-4.1

Exhibit 4.1

 

Execution Copy

 

STANDBY EQUITY DISTRIBUTION AGREEMENT

 

THIS AGREEMENT dated as of the 29th day of September 2008 (this “Agreement”) between YA GLOBAL INVESTMENTS, L.P., a Cayman Islands exempt limited partnership (the “Investor”), and ADVANCED LIFE SCIENCES HOLDINGS, INC., a corporation organized and existing under the laws of the State of Delaware (the “Company”).

 

WHEREAS, the parties desire that, upon the terms and subject to the conditions contained herein, the Company shall issue and sell to the Investor, from time to time as provided herein, and the Investor shall purchase from the Company up to $15,000,000 of the Company’s common stock, par value $0.01 per share (the “Common Stock”); and

 

WHEREAS, such investments will be made in reliance upon the provisions of Regulation D (“Regulation D”) of the Securities Act of 1933, as amended, and the regulations promulgated thereunder (the “Securities Act”), and or upon such other exemption from the registration requirements of the Securities Act as may be available with respect to any or all of the investments to be made hereunder.

 

NOW, THEREFORE, the parties hereto agree as follows:

 

Article I. Certain Definitions

 

Section 1.01           “Advance” shall mean the portion of the Commitment Amount requested by the Company in the Advance Notice.

 

Section 1.02           “Advance Date” shall mean the 1st Trading Day after expiration of the applicable Pricing Period for each Advance.

 

Section 1.03           “Advance Notice” shall mean a written notice in the form of Exhibit A attached hereto to the Investor executed by an officer of the Company and setting forth the Advance amount that the Company requests from the Investor.

 

Section 1.04           “Advance Notice Date” shall mean each date the Company delivers (in accordance with  of this Agreement) to the Investor an Advance Notice requiring the Investor to advance funds to the Company, subject to the terms of this Agreement.  No Advance Notice Date shall be less than 5 Trading Days after the prior Advance Notice Date.

 

Section 1.05           “Bid Price” shall mean, on any date, the closing bid price (as reported by Bloomberg L.P.) of the Common Stock on the Principal Market or if the Common Stock is not traded on a Principal Market, the highest reported bid price for the Common Stock, as furnished by the National Association of Securities Dealers, Inc.

 

Section 1.06           “Closing” shall mean one of the closings of a purchase and sale of Common Stock pursuant to .

 



 

Section 1.07           “Commitment Amount” shall mean the aggregate amount of up to $15,000,000 which the Investor has agreed to provide to the Company in order to purchase the Company’s Common Stock pursuant to the terms and conditions of this Agreement provided that, the Company shall not effect any sales under this Agreement and the Investor shall not have the obligation to purchase shares of Common Stock under this Agreement to the extent that after giving effect to such purchase and sale the aggregate number of shares of Common Stock issued under this Agreement would exceed 7,700,000 shares of Common Stock (which is less than 20% of the 38,521,987 outstanding shares of Common Stock as of the date of this  Agreement) except that such limitation shall not apply in the event that the Company (i) obtains the approval of its stockholders as required by the applicable rules of the Principal Market for the Common Stock for issuances of Common Stock in excess of such amount or (ii) obtains a written opinion from outside counsel to the Company that such approval is not required, which opinion shall be reasonably satisfactory to the Investor.

 

Section 1.08           “Commitment Period” shall mean the period commencing on the Effective Date, and expiring upon the termination of this Agreement in accordance with .

 

Section 1.09           “Common Stock” shall mean the Company’s common stock, par value $0.01 per share.

 

Section 1.10           “Condition Satisfaction Date” shall have the meaning set forth in .

 

Section 1.11           “Damages” shall mean any loss, claim, damage, liability, costs and expenses (including, without limitation, reasonable attorney’s fees and disbursements and costs and expenses of expert witnesses and investigation).

 

Section 1.12           “Effective Date” shall mean the date on which the SEC first declares effective a Registration Statement registering the resale of the Registrable Securities as set forth in .

 

Section 1.13           “Exchange Act” shall mean the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.

 

Section 1.14           “Material Adverse Effect” shall mean any condition, circumstance, or situation that has resulted in, or would reasonably be expected to result in (i) a material adverse effect on the legality, validity or enforceability of this Agreement, (ii) a material adverse effect on the results of operations, assets, business or condition (financial or otherwise) of the Company, taken as a whole, or (iii) a material adverse effect on the Company’s ability to perform in any material respect on a timely basis its obligations under this Agreement.

 

Section 1.15           “Market Price” shall mean the lowest daily VWAP of the Common Stock during the Pricing Period.

 

Section 1.16           “Maximum Advance Amount” shall, per Advance Notice, be the greater of (i) $400,000 or (ii) the average daily trading volume for the 5 Trading Days prior to the Advance Notice Date.

 



 

Section 1.17           “Person” shall mean an individual, a corporation, a partnership, an association, a trust or other entity or organization, including a government or political subdivision or an agency or instrumentality thereof.

 

Section 1.18           “Pricing Period” shall mean the 5 consecutive Trading Days after the Advance Notice Date.

 

Section 1.19           “Principal Market” shall mean the Nasdaq Global Select Market, the Nasdaq Global Market, the Nasdaq Capital Market, the American Stock Exchange, the OTC Bulletin Board or the New York Stock Exchange, whichever is at the time the principal trading exchange or market for the Common Stock.

 

Section 1.20           “Purchase Price” shall be set at 95% of the Market Price during the Pricing Period.

 

Section 1.21           “Registrable Securities” shall mean the shares of Common Stock to be issued hereunder (i) in respect of which the Registration Statement has not been declared effective by the SEC, (ii) which have not been sold under circumstances meeting all of the applicable conditions of Rule 144 (or any similar provision then in force) under the Securities Act (“Rule 144”) or (iii) which have not been otherwise transferred to a holder who may trade such shares without restriction under the Securities Act, and the Company has delivered a new certificate or other evidence of ownership for such securities not bearing a restrictive legend.

 

Section 1.22           “Registration Rights Agreement” shall mean the Registration Rights Agreement dated the date hereof, regarding the filing of the Registration Statement for the resale of the Registrable Securities, entered into between the Company and the Investor.

 

Section 1.23           “Registration Statement” shall mean a registration statement on Form S-3 (if use of such form is then available to the Company pursuant to the rules of the SEC and, if not, Form S-1 or on such other form promulgated by the SEC for which the Company then qualifies and which counsel for the Company shall deem appropriate, and which form shall be available for the resale of the Registrable Securities to be registered thereunder in accordance with the provisions of this Agreement and the Registration Rights Agreement, and in accordance with the intended method of distribution of such securities), for the registration of the resale by the Investor of the Registrable Securities under the Securities Act.

 

Section 1.24           “Regulation D” shall have the meaning set forth in the recitals of this Agreement.

 

Section 1.25           “SEC” shall mean the United States Securities and Exchange Commission.

 

Section 1.26           “Securities Act” shall have the meaning set forth in the recitals of this Agreement.

 

Section 1.27           “Trading Day” shall mean any day during which the New York Stock Exchange shall be open for business.

 

Section 1.28           “VWAP” means, as of any date, the daily dollar volume-weighted average price for such security as reported by Bloomberg, LP through its “Historical Price Table Screen (HP)”

 



 

with Market: Weighted Ave function selected, or, if no dollar volume-weighted average price is reported for such security, then the average of the highest closing bid price and the lowest closing ask price of any of the market makers for such security.

 

Article II. Advances

 

Section 2.01           Advances. Subject to the terms and conditions of this Agreement (including, without limitation, the provisions of Article VII hereof), the Company, at its sole and exclusive option, may issue and sell to the Investor, and the Investor shall purchase from the Company, shares of the Company’s Common Stock by the delivery, in the Company’s sole discretion, of Advance Notices.  The number of shares of Common Stock that the Investor shall purchase pursuant to each Advance shall be determined by dividing the amount of the Advance by the Purchase Price.  No fractional shares shall be issued. Fractional shares shall be rounded to the next higher whole number of shares.  The aggregate maximum amount of all Advances that the Investor shall be obligated to make under this Agreement shall not exceed the Commitment Amount.

 

Section 2.02           Mechanics.

 

(a)               Advance Notice.  At any time during the Commitment Period, the Company may require the Investor to purchase shares of Common Stock by delivering an Advance Notice to the Investor, subject to the conditions set forth in ; provided, however, the amount for each Advance as designated by the Company in the applicable Advance Notice shall not be more than the Maximum Advance Amount and the aggregate amount of the Advances pursuant to this Agreement shall not exceed the Commitment Amount.  The Company acknowledges that the Investor may sell shares of the Company’s Common Stock corresponding with a particular Advance Notice after the Advance Notice is received by the Investor.  There shall be a minimum of 5 Trading Days between each Advance Notice Date.

 

(b)              Date of Delivery of Advance Notice.  Advance Notices shall be delivered in accordance with the instructions set forth on the bottom of Exhibit A.  An Advance Notice shall be deemed delivered on (i) the Trading Day it is received by facsimile or otherwise by the Investor if such notice is received prior to 5:00 pm Eastern Time, or (ii) the immediately succeeding Trading Day if it is received by facsimile or otherwise after 5:00 pm Eastern Time on a Trading Day or at any time on a day which is not a Trading Day.  No Advance Notice may be deemed delivered on a day that is not a Trading Day.

 

Section 2.03           Closings.  On each Advance Date (i) the Company shall deliver to the Investor such number of shares of the Common Stock registered in the name of the Investor as shall equal (x) the amount of the Advance specified in such Advance Notice pursuant to  herein, divided by (y) the Purchase Price and (ii) upon receipt of such shares, the Investor shall deliver to the Company the amount of the Advance specified in the Advance Notice by wire transfer of immediately available funds.  In addition, on or prior to the Advance Date, each of the Company and the Investor shall deliver to the other all documents, instruments and writings required to be delivered by either of them pursuant to this Agreement in order to implement and effect the

 



 

transactions contemplated herein.  To the extent the Company has not paid the fees, expenses, and disbursements of the Investor in accordance with , the amount of such fees, expenses, and disbursements may be deducted by the Investor (and shall be paid to the relevant party) directly out of the proceeds of the Advance with no reduction in the amount of shares of the Company’s Common Stock to be delivered on such Advance Date.

 

(a)               Company’s Obligations Upon Closing.

 

(i)      The Company shall deliver to the Investor the shares of Common Stock applicable to the Advance in accordance with .  The certificates evidencing such shares shall be free of restrictive legends.

 

(ii)     The Registration Statement shall be effective and available for the resale of all applicable shares of Common Stock to be issued in connection with the Advance and certificates evidencing such shares shall be free of restrictive legends.

 

(iii)    The Company shall have obtained all material permits and qualifications required by any applicable state for the offer and sale of the Registrable Securities, or shall have the availability of exemptions therefrom.  The sale and issuance of the Registrable Securities shall be legally permitted by all laws and regulations to which the Company is subject.

 

(iv)    The Company shall have filed with the SEC in a timely manner all reports, notices and other documents required of a “reporting company” under the Exchange Act and applicable Commission regulations.

 

(v)     The Company shall pay any unpaid fees as set forth in  or withhold such amounts as provided in .

 

(vi)    The Company’s transfer agent shall be DWAC eligible.

 

(b)     Investor’s Obligations Upon Closing.  Upon receipt of the shares referenced in Section 2.03(a)(i) above and provided the Company is in compliance with its obligations in , the Investor shall deliver to the Company the amount of the Advance specified in the Advance Notice by wire transfer of immediately available funds.

 

Section 2.04           Hardship.  In the event the Investor sells shares of the Company’s Common Stock after receipt of an Advance Notice and the Company fails to perform its obligations as mandated in , and specifically the Company fails to deliver to the Investor on the Advance Date the shares of Common Stock corresponding to the applicable Advance pursuant to Section 2.03(a)(i), the Company acknowledges that the Investor shall suffer financial hardship and therefore shall be liable for any and all losses, commissions, fees, or financial hardship caused to the Investor.

 

Article III. Representations and Warranties of Investor

 

Investor hereby represents and warrants to, and agrees with, the Company that the following are true and correct as of the date hereof and as of each Advance Date:

 



 

Section 3.01           Organization and Authorization.  The Investor is duly incorporated or organized and validly existing in the jurisdiction of its incorporation or organization and has all requisite power and authority to purchase and hold the securities issuable hereunder.  The decision to invest and the execution and delivery of this Agreement by such Investor, the performance by such Investor of its obligations hereunder and the consummation by such Investor of the transactions contemplated hereby have been duly authorized and requires no other proceedings on the part of the Investor.  The undersigned has the right, power and authority to execute and deliver this Agreement and all other instruments (including, without limitations, the Registration Rights Agreement), on behalf of the Investor.  This Agreement has been duly executed and delivered by the Investor and, assuming the execution and delivery hereof and acceptance thereof by the Company, will constitute the legal, valid and binding obligations of the Investor, enforceable against the Investor in accordance with its terms.

 

Section 3.02           Evaluation of Risks.  The Investor has such knowledge and experience in financial, tax and business matters as to be capable of evaluating the merits and risks of, and bearing the economic risks entailed by, an investment in the Company and of protecting its interests in connection with this transaction.  It recognizes that its investment in the Company involves a high degree of risk.

 

Section 3.03           No Legal Advice From the Company.  The Investor acknowledges that it had the opportunity to review this Agreement and the transactions contemplated by this Agreement with his or its own legal counsel and investment and tax advisors.  The Investor is relying solely on such counsel and advisors and not on any statements or representations of the Company or any of its representatives or agents for legal, tax or investment advice with respect to this investment, the transactions contemplated by this Agreement or the securities laws of any jurisdiction.

 

Section 3.04           Investment Purpose. The securities are being purchased by the Investor for its own account, and for investment purposes.  The Investor agrees not to assign or in any way transfer the Investor’s rights to the securities or any interest therein and acknowledges that the Company will not recognize any purported assignment or transfer except in accordance with applicable Federal and state securities laws.  No other person has or will have a direct or indirect beneficial interest in the securities.  The Investor agrees not to sell, hypothecate or otherwise transfer the Investor’s securities unless the securities are registered under Federal and applicable state securities laws or unless, in the opinion of counsel satisfactory to the Company, an exemption from such laws is available.

 

Section 3.05           Accredited Investor.  The Investor is an “Accredited Investor” as that term is defined in Rule 501(a)(3) of Regulation D of the Securities Act.

 

Section 3.06           Information.  The Investor and its advisors (and its counsel), if any, have been furnished with all materials relating to the business, finances and operations of the Company and information it deemed material to making an informed investment decision.  The Investor and its advisors, if any, have been afforded the opportunity to ask questions of the Company and its management.  Neither such inquiries nor any other due diligence investigations conducted by such Investor or its advisors, if any, or its representatives shall modify, amend or affect the Investor’s right to rely on the Company’s representations and warranties contained in this Agreement.  The Investor understands that its investment involves a high degree of risk.  The

 



 

Investor is in a position regarding the Company, which, based upon employment, family relationship or economic bargaining power, enabled and enables such Investor to obtain information from the Company in order to evaluate the merits and risks of this investment.  The Investor has sought such accounting, legal and tax advice, as it has considered necessary to make an informed investment decision with respect to this transaction.

 

Section 3.07           Receipt of Documents. The Investor and its counsel have received and read in their entirety:  (i) this Agreement and the Exhibits annexed hereto; (ii) all due diligence and other information necessary to verify the accuracy and completeness of such representations, warranties and covenants; (iii) the Company’s Form 10-K for the year ended December 31, 2007, Forms 10-Q for the periods ended March 31, 2008 and June 30, 2008 and Forms 8K filed on February 5, 2008, February 19, 2008, March 7, 2008, April 18, 2008, May 7, 2008 and August 14, 2008; and (iv) answers to all questions the Investor submitted to the Company regarding an investment in the Company; and the Investor has relied on the information contained therein and has not been furnished any other documents, literature, memorandum or prospectus.

 

Section 3.08           No General Solicitation.  Neither the Company, nor any of its affiliates, nor any person acting on its or their behalf, has engaged in any form of general solicitation or general advertising (within the meaning of Regulation D under the Securities Act) in connection with the offer or sale of the shares of Common Stock offered hereby.

 

Section 3.09           Not an Affiliate.  The Investor is not an officer, director or a person that directly, or indirectly through one or more intermediaries, controls or is controlled by, or is under common control with the Company or any “Affiliate” of the Company (as that term is defined in Rule 405 of the Securities Act).

 

Section 3.10           Trading Activities.  The Investor’s trading activities with respect to the Company’s Common Stock shall be in compliance with all applicable federal and state securities laws, rules and regulations and the rules and regulations of the Principal Market on which the Company’s Common Stock is listed or traded. Neither the Investor nor its affiliates has an open short position in the Common Stock of the Company, the Investor agrees that it shall not, and that it will cause its affiliates not to, engage in any short sales of or hedging transactions with respect to the Common Stock, provided that the Company acknowledges and agrees that upon receipt of an Advance Notice the Investor has the right to sell the shares to be issued to the Investor pursuant to the Advance Notice during the applicable Pricing Period.

 

Article IV. Representations and Warranties of the Company

 

Except as stated below, on the disclosure schedules attached hereto or in the SEC Documents (as defined herein), the Company hereby represents and warrants to, and covenants with, the Investor that the following are true and correct as of the date hereof:

 

Section 4.01           Organization and Qualification.  The Company is duly incorporated or organized and validly existing in the jurisdiction of its incorporation or organization and has all requisite corporate power to own its properties and to carry on its business as now being conducted.  Each of the Company and its subsidiaries is duly qualified as a foreign corporation to do business and

 



 

is in good standing in every jurisdiction in which the nature of the business conducted by it makes such qualification necessary, except to the extent that the failure to be so qualified or be in good standing would not have a Material Adverse Effect.

 

Section 4.02           Authorization, Enforcement, Compliance with Other Instruments.  (i) The Company has the requisite corporate power and authority to enter into and perform this Agreement, the Registration Rights Agreement and any related agreements, in accordance with the terms hereof and thereof, (ii) the execution and delivery of this Agreement, the Registration Rights Agreement and any related agreements by the Company and the consummation by it of the transactions contemplated hereby and thereby, have been duly authorized by the Company’s Board of Directors and no further consent or authorization is required by the Company, its Board of Directors or its stockholders, (iii) this Agreement, the Registration Rights Agreement and any related agreements have been duly executed and delivered by the Company, (iv) this Agreement, the Registration Rights Agreement and assuming the execution and delivery thereof and acceptance by the Investor and any related agreements constitute the valid and binding obligations of the Company enforceable against the Company in accordance with their terms, except as such enforceability may be limited by general principles of equity or applicable bankruptcy, insolvency, reorganization, moratorium, liquidation or similar laws relating to, or affecting generally, the enforcement of creditors’ rights and remedies.

 

Section 4.03           Capitalization.  The authorized capital stock of the Company consists of 60,000,000 shares of Common Stock and 5,000,000 shares of preferred stock, no par value per share (“Preferred Stock”), of which 38,521,987 shares (as may be increased as set forth in the last sentence of this Section 4.03) of Common Stock and 0 shares of Preferred Stock are issued and outstanding.  All of such outstanding shares have been validly issued and are fully paid and nonassessable.  Except as disclosed in the SEC Documents and the last sentence of this Section 4.03, no shares of Common Stock are subject to preemptive rights or any other similar rights or any liens or encumbrances suffered or permitted by the Company.  Except as disclosed in the SEC Documents, as of the date hereof, (i) there are no outstanding options, warrants, scrip, rights to subscribe to, calls or commitments of any character whatsoever relating to, or securities or rights convertible into, any shares of capital stock of the Company or any of its subsidiaries, or contracts, commitments, understandings or arrangements by which the Company or any of its subsidiaries is or may become bound to issue additional shares of capital stock of the Company or any of its subsidiaries or options, warrants, scrip, rights to subscribe to, calls or commitments of any character whatsoever relating to, or securities or rights convertible into, any shares of capital stock of the Company or any of its subsidiaries, (ii) there are no outstanding debt securities (iii) there are no outstanding registration statements other than on Form S-8 and Registration Statements No. 333-148483 filed on Form S-3 and No. 333-132900 filed on Form S-3 and (iv) other than the Stock Purchase Agreements dated as of February 24, 2006 and December 13, 2007 between the Company and various investors, there are no agreements or arrangements under which the Company or any of its subsidiaries is obligated to register the sale of any of their securities under the Securities Act (except pursuant to the Registration Rights Agreement).  There are no securities or instruments containing anti-dilution or similar provisions that will be triggered by this Agreement or any related agreement or the consummation of the transactions described herein or therein.  The Company has furnished to the Investor true and correct copies of the Company’s Certificate of Incorporation, as amended and as in effect on the date hereof (the “Certificate of Incorporation”), and the Company’s By-laws, as in effect on the

 



 

date hereof (the “By-laws”), and the terms of all securities convertible into or exercisable for Common Stock and the material rights of the holders thereof in respect thereto.  On or about the date hereof, the Company expects to (i) enter into that certain Stock Purchase Agreement with a private investor, pursuant to which such investor shall purchase a number of shares equal to less than 5.0% of the Company’s outstanding Common Stock and such investor shall receive certain “piggyback” registration rights in connection therewith and (ii) enter into a commitment letter with the Company’s bank lender obligating the Company to issue warrants for a number of shares of Common Stock not exceeding 100,000.

 

Section 4.04           No Conflict.  The execution, delivery and performance of this Agreement by the Company and the consummation by the Company of the transactions contemplated hereby will not (i) result in a violation of the Certificate of Incorporation, any certificate of designations of any outstanding series of preferred stock of the Company or By-laws or (ii) conflict with or constitute a default (or an event which with notice or lapse of time or both would become a default) under, or give to others any rights of termination, amendment, acceleration or cancellation of, any agreement, indenture or instrument to which the Company or any of its subsidiaries is a party, or result in a violation of any law, rule, regulation, order, judgment or decree (including federal and state securities laws and regulations and the rules and regulations of the Principal Market on which the Common Stock is quoted) applicable to the Company or any of its subsidiaries or by which any material property or asset of the Company or any of its subsidiaries is bound or affected and which would cause a Material Adverse Effect.  Except as disclosed in the SEC Documents, neither the Company nor its subsidiaries is in violation of any term of or in default under its Articles of Incorporation or By-laws or their organizational charter or by-laws, respectively, or any material contract, agreement, mortgage, indebtedness, indenture, instrument, judgment, decree or order or any statute, rule or regulation applicable to the Company or its subsidiaries.  The business of the Company and its subsidiaries is not being conducted in violation of any material law, ordinance or regulation of any governmental entity.  Except as specifically contemplated by this Agreement and as required under the Securities Act and any applicable state securities laws, the Company is not required to obtain any consent, authorization or order of, or make any filing or registration with, any court or governmental agency in order for it to execute, deliver or perform any of its obligations under or contemplated by this Agreement or the Registration Rights Agreement in accordance with the terms hereof or thereof.  All consents, authorizations, orders, filings and registrations which the Company is required to obtain pursuant to the preceding sentence have been obtained or effected on or prior to the date hereof.  The Company and its subsidiaries are unaware of any fact or circumstance which might give rise to any of the foregoing.

 

Section 4.05           SEC Documents; Financial Statements.  The Company has filed all reports, schedules, forms, statements and other documents required to be filed by it with the SEC under the Securities Exchange Act for the two years preceding the date hereof (or such shorter period as the Company was required by law or regulation to file such material) (all of the foregoing filed prior to the date hereof or amended after the date hereof and all exhibits included therein and financial statements and schedules thereto and documents incorporated by reference therein, being hereinafter referred to as the “SEC Documents”) on timely basis or has received a valid extension of such time of filing and has filed any such SEC Document prior to the expiration of any such extension.  The Company has delivered to the Investors or their representatives, or made available through the SEC’s website at http://www.sec.gov, true and complete copies of

 



 

the SEC Documents.  As of their respective dates, the SEC Documents complied in all material respects with the requirements of the Exchange Act and the rules and regulations of the SEC promulgated thereunder applicable to the SEC Documents, and none of the SEC Documents, at the time they were filed with the SEC, contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading.  As of their respective dates, the financial statements of the Company included in the SEC Documents complied as to form in all material respects with applicable accounting requirements and the published rules and regulations of the SEC with respect thereto.  Such financial statements have been prepared in accordance with generally accepted accounting principles, consistently applied, during the periods involved (except (i) as may be otherwise indicated in such financial statements or the notes thereto, or (ii) in the case of unaudited interim statements, to the extent they may exclude footnotes or may be condensed or summary statements) and fairly present in all material respects the financial position of the Company as of the dates thereof and the results of its operations and cash flows for the periods then ended (subject, in the case of unaudited statements, to normal year-end audit adjustments).  No other information provided by or on behalf of the Company to the Investors which is not included in the SEC Documents contains any untrue statement of a material fact or omits to state any material fact necessary in order to make the statements therein, in the light of the circumstance under which they are or were made and not misleading.

 

Section 4.06           10b-5.  The SEC Documents do not include any untrue statements of material fact, nor do they omit to state any material fact required to be stated therein necessary to make the statements made, in light of the circumstances under which they were made, not misleading.

 

Section 4.07           No Default.  Except as disclosed in the SEC Documents, the Company is not in default in the performance or observance of any material obligation, agreement, covenant or condition contained in any indenture, mortgage, deed of trust or other material instrument or agreement to which it is a party or by which it is or its property is bound and neither the execution, nor the delivery by the Company, nor the performance by the Company of its obligations under this Agreement or any of the exhibits or attachments hereto will conflict with or result in the breach or violation of any of the terms or provisions of, or constitute a default or result in the creation or imposition of any lien or charge on any assets or properties of the Company under its Certificate of Incorporation, By-Laws, any material indenture, mortgage, deed of trust or other material agreement applicable to the Company or instrument to which the Company is a party or by which it is bound, or any statute, or any decree, judgment, order, rules or regulation of any court or governmental agency or body having jurisdiction over the Company or its properties, in each case which default, lien or charge is likely to cause a Material Adverse Effect.

 

Section 4.08           Absence of Events of Default.  Except for matters described in the SEC Documents and/or this Agreement, no Event of Default, as defined in the respective agreement to which the Company is a party, and no event which, with the giving of notice or the passage of time or both, would become an Event of Default (as so defined), has occurred and is continuing, which would have a Material Adverse Effect.

 



 

Section 4.09           Intellectual Property Rights.  The Company and its subsidiaries own or possess adequate rights or licenses to use all material trademarks, trade names, service marks, service mark registrations, service names, patents, patent rights, copyrights, inventions, licenses, approvals, governmental authorizations, trade secrets and rights necessary to conduct their respective businesses as now conducted.   The Company and its subsidiaries do not have any knowledge of any infringement by the Company or its subsidiaries of trademark, trade name rights, patents, patent rights, copyrights, inventions, licenses, service names, service marks, service mark registrations, trade secret or other similar rights of others, and, to the knowledge of the Company, there is no claim, action or proceeding being made or brought against, or to the Company’s knowledge, being threatened against, the Company or its subsidiaries regarding trademark, trade name, patents, patent rights, invention, copyright, license, service names, service marks, service mark registrations, trade secret or other infringement.

 

Section 4.10           Employee Relations.  Neither the Company nor any of its subsidiaries is involved in any labor dispute nor, to the knowledge of the Company or any of its subsidiaries, is any such dispute threatened.  None of the Company’s or its subsidiaries’ employees is a member of a union and the Company and its subsidiaries believe that their relations with their employees are good.

 

Section 4.11           Environmental Laws.  Except as would not have a Material Adverse Effect, the Company and its subsidiaries are (i) in compliance with any and all applicable material foreign, federal, state and local laws and regulations relating to the protection of human health and safety, the environment or hazardous or toxic substances or wastes, pollutants or contaminants (“Environmental Laws”), (ii) have received all permits, licenses or other approvals required of them under applicable Environmental Laws to conduct their respective businesses and (iii) are in compliance with all terms and conditions of any such permit, license or approval.

 

Section 4.12           Title.  Except as set forth in the SEC Documents, the Company has good and marketable title to its properties and material assets owned by it, free and clear of any pledge, lien, security interest, encumbrance, claim or equitable interest other than such as are not material to the business of the Company.  Any real property and facilities held under lease by the Company and its subsidiaries are held by them under valid, subsisting and enforceable leases with such exceptions as are not material and do not interfere with the use made and proposed to be made of such property and buildings by the Company and its subsidiaries.

 

Section 4.13           Insurance.  The Company and each of its subsidiaries are insured by insurers of recognized financial responsibility against such losses and risks and in such amounts as management of the Company believes to be prudent and customary for similarly situated companies in the businesses in which the Company and its subsidiaries are engaged.  Neither the Company nor any such subsidiary has any reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage expires or to obtain similar coverage from similar insurers as may be necessary to continue its business at a cost that would not have a Material Adverse Effect.

 

Section 4.14           Regulatory Permits.  The Company and its subsidiaries possess all material certificates, authorizations and permits issued by the appropriate federal, state or foreign regulatory authorities necessary to conduct their respective businesses, and neither the Company

 



 

nor any such subsidiary has received any notice of proceedings relating to the revocation or modification of any such certificate, authorization or permit.

 

Section 4.15                                Internal Accounting Controls.  The Company and each of its subsidiaries maintain a system of internal accounting controls sufficient to provide reasonable assurance that (i) transactions are executed in accordance with management’s general or specific authorizations, (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with generally accepted accounting principles and to maintain asset accountability, (iii) access to assets is permitted only in accordance with management’s general or specific authorization and (iv) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences.

 

Section 4.16                                Absence of Litigation.  Except as set forth in the SEC Documents, there is no action, suit, proceeding, inquiry or investigation before or by any court, public board, government agency, self-regulatory organization or body pending against or affecting the Company, the Common Stock or any of the Company’s subsidiaries, wherein an unfavorable decision, ruling or finding would (i) have a material adverse effect on the transactions contemplated hereby (ii) adversely affect the validity or enforceability of, or the authority or ability of the Company to perform its obligations under, this Agreement or any of the documents contemplated herein, or (iii) except as expressly disclosed in the SEC Documents, have a Material Adverse Effect.

 

Section 4.17                                Subsidiaries.  Except as disclosed in the SEC Documents, the Company does not presently own or control, directly or indirectly, any interest in any other corporation, partnership, association or other business entity.

 

Section 4.18                                Tax Status.  Except as disclosed in the SEC Documents, the Company and each of its subsidiaries has made or filed all federal and state income and all other tax returns, reports and declarations required by any jurisdiction to which it is subject and (unless and only to the extent that the Company and each of its subsidiaries has set aside on its books provisions reasonably adequate for the payment of all unpaid and unreported taxes) has paid all taxes and other governmental assessments and charges that are material in amount, shown or determined to be due on such returns, reports and declarations, except those being contested in good faith and has set aside on its books provision reasonably adequate for the payment of all taxes for periods subsequent to the periods to which such returns, reports or declarations apply.  There are no unpaid taxes in any material amount claimed to be due by the taxing authority of any jurisdiction, and the officers of the Company know of no basis for any such claim.

 

Section 4.19                                Certain Transactions.  Except as set forth in the SEC Documents none of the officers, directors, or employees of the Company is presently a party to any transaction with the Company (other than for services as employees, officers and directors), including any contract, agreement or other arrangement providing for the furnishing of services to or by, providing for rental of real or personal property to or from, or otherwise requiring payments to or from any officer, director or such employee or, to the knowledge of the Company, any corporation, partnership, trust or other entity in which any officer, director, or any such employee has a substantial interest or is an officer, director, trustee or partner.

 



 

Section 4.20                                Fees and Rights of First Refusal.  The Company is not obligated to offer the securities offered hereunder on a right of first refusal basis or otherwise to any third parties including, but not limited to, current or former shareholders of the Company, underwriters, brokers, agents or other third parties.

 

Section 4.21                                Use of Proceeds.  The Company shall use the net proceeds from this offering for working capital and other general corporate purposes.

 

Section 4.22                                Opinion of Counsel.  Investor shall receive an opinion letter from counsel to the Company on the date hereof.

 

Section 4.23                                Dilution.  The Company is aware and acknowledges that issuance of shares of the Company’s Common Stock could cause dilution to existing shareholders and could significantly increase the outstanding number of shares of Common Stock.

 

Section 4.24                                Acknowledgment Regarding Investor’s Purchase of Shares. The Company acknowledges and agrees that the Investor is acting solely in the capacity of an arm’s length investor with respect to this Agreement and the transactions contemplated hereunder. The Company further acknowledges that the Investor is not acting as a financial advisor or fiduciary of the Company (or in any similar capacity) with respect to this Agreement and the transactions contemplated hereunder and any advice given by the Investor or any of its representatives or agents in connection with this Agreement and the transactions contemplated hereunder is merely incidental to the Investor’s purchase of the Common Stock hereunder.  The Company is aware and acknowledges that it may not be able to request Advances under this Agreement if it cannot obtain an effective Registration Statement or if any issuances of Common Stock pursuant to any Advances would violate any rules of the Principal Market.  The Company further is aware and acknowledges that any fees paid pursuant to  hereunder or shares issued pursuant to  hereunder shall be earned on the date hereof and not refundable or returnable under any circumstances.

 

Article V.   Indemnification

 

The Investor and the Company represent to the other the following with respect to itself:

 

Section 5.01                                Indemnification.

 

(a)              In consideration of the Investor’s execution and delivery of this Agreement, and in addition to all of the Company’s other obligations under this Agreement, the Company shall defend, protect, indemnify and hold harmless the Investor, and all of its officers, directors, partners, employees and agents (including, without limitation, those retained in connection with the transactions contemplated by this Agreement) (collectively, the “Investor Indemnitees”) from and against any and all actions, causes of action, suits, claims, losses, costs, penalties, fees, liabilities and damages, and expenses in connection therewith (irrespective of whether any such Investor Indemnitee is a party to the action for which indemnification hereunder is sought), and including reasonable attorneys’ fees and disbursements (the “Indemnified Liabilities”), incurred by the Investor Indemnitees or any of them as a result of, or arising out of, or relating to (a) any misrepresentation or breach of any representation or warranty made by the Company in this Agreement or the

 



 

Registration Rights Agreement or any other certificate, instrument or document contemplated hereby or thereby, (b) any breach of any covenant, agreement or obligation of the Company contained in this Agreement or the Registration Rights Agreement or any other certificate, instrument or document contemplated hereby or thereby, or (c) any cause of action, suit or claim brought or made against such Investor Indemnitee not arising out of any action or inaction of an Investor Indemnitee, and arising out of or resulting from the execution, delivery, performance or enforcement of this Agreement or any other instrument, document or agreement executed pursuant hereto by any of the Investor Indemnitees.  To the extent that the foregoing undertaking by the Company may be unenforceable for any reason, the Company shall make the maximum contribution to the payment and satisfaction of each of the Indemnified Liabilities, which is permissible under applicable law.

 

(b)             In consideration of the Company’s execution and delivery of this Agreement, and in addition to all of the Investor’s other obligations under this Agreement, the Investor shall defend, protect, indemnify and hold harmless the Company and all of its officers, directors, shareholders, employees and agents (including, without limitation, those retained in connection with the transactions contemplated by this Agreement) (collectively, the “Company Indemnitees”) from and against any and all Indemnified Liabilities incurred by the Company Indemnitees or any of them as a result of, or arising out of, or relating to (a) any misrepresentation or breach of any representation or warranty made by the Investor in this Agreement, the Registration Rights Agreement, or any instrument or document contemplated hereby or thereby executed by the Investor, (b) any breach of any covenant, agreement or obligation of the Investor(s) contained in this Agreement,  the Registration Rights Agreement or any other certificate, instrument or document contemplated hereby or thereby executed by the Investor, or (c) any cause of action, suit or claim brought or made against such Company Indemnitee based on  misrepresentations or due to a  breach by the Investor and arising out of or resulting from the execution, delivery, performance or enforcement of this Agreement or any other instrument, document or agreement executed pursuant hereto by any of the Company Indemnitees.  To the extent that the foregoing undertaking by the Investor may be unenforceable for any reason, the Investor shall make the maximum contribution to the payment and satisfaction of each of the Indemnified Liabilities, which is permissible under applicable law.

 

(c)              The obligations of the parties to indemnify or make contribution under this  shall survive termination.

 

Article VI.
Covenants of the Company

 

Section 6.01                                Registration Rights.  The Company shall cause the Registration Rights Agreement to remain in full force and effect and the Company shall comply in all material respects with the terms thereof.

 



 

Section 6.02                                Listing of Common Stock.  The Company shall use its commercially reasonable efforts to maintain the Common Stock’s authorization for quotation on the Principal Market.

 

Section 6.03                                Exchange Act Registration.  The Company will cause its Common Stock to continue to be registered under Section 12(g) of the Exchange Act, will file in a timely manner all reports and other documents required of it as a reporting company under the Exchange Act and will not take any action or file any document (whether or not permitted by Exchange Act or the rules thereunder) to terminate or suspend such registration or to terminate or suspend its reporting and filing obligations under said Exchange Act.

 

Section 6.04                                Transfer Agent Instructions.  Upon effectiveness of the Registration Statement the Company shall deliver instructions to its transfer agent to issue shares of Common Stock to the Investor free of restrictive legends on or before each Advance Date.

 

Section 6.05                                Corporate Existence.  The Company will take all steps necessary to preserve and continue the corporate existence of the Company.

 

Section 6.06                                Notice of Certain Events Affecting Registration; Suspension of Right to Make an Advance.  The Company will immediately notify the Investor upon its becoming aware of the occurrence of any of the following events in respect of a registration statement or related prospectus relating to an offering of Registrable Securities: (i) receipt of any request for additional information by the SEC or any other Federal or state governmental authority during the period of effectiveness of the Registration Statement for amendments or supplements to the registration statement or related prospectus; (ii) the issuance by the SEC or any other Federal or state governmental authority of  any stop order suspending the effectiveness of the Registration Statement or the initiation of any proceedings for that purpose; (iii) receipt of any notification with respect to the suspension of the qualification or exemption from qualification of any of the Registrable Securities for sale in any jurisdiction or the initiation or threatening of any proceeding for such purpose; (iv) the happening of any event that makes any statement made in the Registration Statement or related prospectus of any document incorporated or deemed to be incorporated therein by reference untrue in any material respect or that requires the making of any changes in the Registration Statement, related prospectus or documents so that, in the case of the Registration Statement, it will not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein not misleading, and that in the case of the related prospectus, it will not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading; and (v) the Company’s reasonable determination that a post-effective amendment to the Registration Statement would be appropriate; and the Company will promptly make available to the Investor any such supplement or amendment to the related prospectus.  The Company shall not deliver to the Investor any Advance Notice during the continuation of any of the foregoing events.

 

Section 6.07                                Consolidation; Merger.  The Company shall not, at any time after the date hereof, effect any merger or consolidation of the Company with or into, or a transfer of all or substantially all the assets of the Company to another entity (a “Consolidation Event”) unless the resulting successor or acquiring entity (if not the Company) assumes by written instrument the

 



 

obligation to deliver to the Investor such shares of stock and/or securities as the Investor is entitled to receive pursuant to this Agreement.

 

Section 6.08                                Issuance of the Company’s Common Stock.  The sale of the shares of Common Stock shall be made in accordance with the provisions and requirements of Regulation D and any applicable state securities law.

 

Section 6.09                                Review of Public Disclosures.  None of the public disclosures made by the Company, including, without limitation, press releases, investor relations materials, and scripts of analysts meetings and calls will contain any untrue statements of material fact, nor will they omit to state any material fact required to be stated therein necessary to make the statements made, in light of the circumstances under which they were made, not misleading.

 

Section 6.10                                Market Activities.  The Company will not, directly or indirectly, (i) take any action designed to cause or result in, or that constitutes or might reasonably be expected to constitute, the stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of the Common Stock or (ii) sell, bid for or purchase the Common Stock, or pay anyone any compensation for soliciting purchases of the Common Stock.

 

Section 6.11                                Opinion of Counsel.  Provided that the Investor’s resale of Common Stock received pursuant to this Agreement may be freely sold by the Investor either pursuant to an effective Registration Statement, in accordance with Rule 144, or otherwise, the Company shall obtain for the Investor, at the Company’s expense, any and all opinions of counsel which may be required by the Company’s transfer agent to issue such shares free of restrictive legends, or to remove legends from such shares.

 

Article VII.
Conditions for Advance and Conditions to Closing

 

Section 7.01                                Conditions Precedent to the Obligations of the Company.  The obligation hereunder of the Company to issue and sell the shares of Common Stock to the Investor incident to each Closing is subject to the satisfaction, or waiver by the Company, at or before each such Closing, of each of the conditions set forth below.

 

(a)               Accuracy of the Investor’s Representations and Warranties.  The representations and warranties of the Investor shall be true and correct in all material respects.

 

(b)              Performance by the Investor.  The Investor shall have performed, satisfied and complied in all respects with all covenants, agreements and conditions required by this Agreement and the Registration Rights Agreement to be performed, satisfied or complied with by the Investor at or prior to such Closing.

 

Section 7.02                                Conditions Precedent to the Right of the Company to Deliver an Advance Notice.  The right of the Company to deliver an Advance Notice is subject to the fulfillment by the Company, on such Advance Notice Date (a “Condition Satisfaction Date”), of each of the following conditions:

 



 

(a)               Registration of the Common Stock with the SEC.  There is an effective Registration Statement pursuant to which the Investor is permitted to utilize the prospectus thereunder to resell all of the shares of Common Stock issuable pursuant to such Advance Notice, and the Company believes, in good faith, that such effectiveness will continue uninterrupted for the foreseeable future.  Neither the Company nor the Investor shall have received notice that the SEC has issued or intends to issue a stop order with respect to the Registration Statement or that the SEC otherwise has suspended or withdrawn the effectiveness of the Registration Statement, either temporarily or permanently, or intends or has threatened to do so (unless the SEC’s concerns have been addressed and the Investor is reasonably satisfied that the SEC no longer is considering or intends to take such action), and (ii) no other suspension of the use or withdrawal of the effectiveness of the Registration Statement or related prospectus shall exist.

 

(b)              Authority.  The Company shall have obtained all permits and qualifications required by any applicable state in accordance with the Registration Rights Agreement for the offer and sale of the shares of Common Stock, or shall have the availability of exemptions therefrom.  The sale and issuance of the shares of Common Stock shall be legally permitted by all laws and regulations to which the Company is subject.

 

(c)               Fundamental Changes. There shall not exist any fundamental changes to the information set forth in the Registration Statement which would require the Company to file a post-effective amendment to the Registration Statement.

 

(d)              Performance by the Company.  The Company shall have performed, satisfied and complied in all material respects with all covenants, agreements and conditions required by this Agreement and the Registration Rights Agreement to be performed, satisfied or complied with by the Company at or prior to each Condition Satisfaction Date.

 

(e)               No Injunction.  No statute, rule, regulation, executive order, decree, ruling or injunction shall have been enacted, entered, promulgated or endorsed by any court or governmental authority of competent jurisdiction that prohibits or directly and adversely affects any of the transactions contemplated by this Agreement, and no proceeding shall have been commenced that may have the effect of prohibiting or adversely affecting any of the transactions contemplated by this Agreement.

 

(f)                 No Suspension of Trading in or Delisting of Common Stock.  The Common Stock is trading on a Principal Market and all of the shares issuable pursuant to such Advance Notice will be listed or quoted for trading on such Principal Market (and the Company believes, in good faith, that trading of the Common Stock on a Principal Market will continue uninterrupted for the foreseeable future.  The issuance of shares of Common Stock with respect to the applicable Advance Notice will not violate the shareholder approval requirements of the Principal Market.  The Company shall not have received any notice threatening the continued listing of the Common Stock on the Principal Market.

 

(g)              Maximum Advance Amount.  The amount of an Advance requested by the Company shall not exceed the Maximum Advance Amount.  In addition, in no event shall the

 



 

number of shares issuable to the Investor pursuant to an Advance cause the aggregate number of shares of Common Stock beneficially owned by the Investor and its affiliates to exceed 9.99% of the then outstanding Common Stock of the Company (“Ownership Limitation”).  Any portion of an Advance that would cause the Investor to exceed the Ownership Limitation shall automatically be withdrawn.  For the purposes of this section beneficial ownership shall be calculated in accordance with Section 13(d) of the Exchange Act.

 

(h)              Authorized.  There shall be a sufficient number of authorized but unissued and otherwise unreserved shares of Common Stock for the issuance of all of the shares issuable pursuant to such Advance Notice.

 

(i)                  Executed Advance Notice.  The Investor shall have received the Advance Notice executed by an officer of the Company and the representations contained in such Advance Notice shall be true and correct as of each Condition Satisfaction Date.

 

Article VIII.
Due Diligence Review; Non-Disclosure of Non-Public Information

 

Section 8.01                                Non-Disclosure of Non-Public Information.

 

(a)              The Company covenants and agrees that it shall refrain from disclosing, and shall cause its officers, directors, employees and agents to refrain from disclosing, any material non-public information to the Investor without also disseminating such information to the public, unless prior to disclosure of such information the Company identifies such information as being material non-public information and provides the Investor with the opportunity to accept or refuse to accept such material non-public information for review.

 

(b)             Nothing herein shall require the Company to disclose non-public information to the Investor or its advisors or representatives, and the Company represents that it does not disseminate non-public information to any investors who purchase stock in the Company in a public offering, to money managers or to securities analysts, provided, however, that notwithstanding anything herein to the contrary, the Company will, as hereinabove provided, immediately notify the advisors and representatives of the Investor and, if any, underwriters, of any event or the existence of any circumstance (without any obligation to disclose the specific event or circumstance) of which it becomes aware, constituting non-public information (whether or not requested of the Company specifically or generally during the course of due diligence by such persons or entities), which, if not disclosed in the prospectus included in the Registration Statement would cause such prospectus to include a material misstatement or to omit a material fact required to be stated therein in order to make the statements, therein, in light of the circumstances in which they were made, not misleading.  Nothing contained in this  shall be construed to mean that such persons or entities other than the Investor (without the written consent of the Investor prior to disclosure of such information) may not obtain non-public information in the course of conducting due diligence in accordance with the terms of this Agreement and nothing herein shall prevent any such persons or entities from notifying the Company of

 



 

their opinion that based on such due diligence by such persons or entities, that the Registration Statement contains an untrue statement of material fact or omits a material fact required to be stated in the Registration Statement or necessary to make the statements contained therein, in light of the circumstances in which they were made, not misleading.

 

Article IX.
Choice of Law/Jurisdiction

 

This Agreement shall be governed by and interpreted in accordance with the laws of the State of New Jersey without regard to the principles of conflict of laws.  The parties further agree that any action between them shall be heard in Hudson County, New Jersey, and expressly consent to the jurisdiction and venue of the Superior Court of New Jersey, sitting in Hudson County, New Jersey and the United States District Court of New Jersey, sitting in Newark, New Jersey, for the adjudication of any civil action asserted pursuant to this paragraph.

 

Article X. Assignment; Termination

 

Section 10.01                          Assignment.  Neither this Agreement nor any rights or obligations of either party hereunder may be assigned to any other Person.

 

Section 10.02                          Termination.

 

(a)               Unless earlier terminated as provided hereunder, this Agreement shall terminate automatically on the earliest of (i) the first day of the month next following the 24-month anniversary of the Effective Date, or (ii) the date on which the Investor shall have made payment of Advances pursuant to this Agreement in the aggregate amount of the Commitment Amount.

 

(b)              The Company may terminate this Agreement effective upon fifteen Trading Days’ prior written notice to the Investor; provided that (i) there are no Advances outstanding, and (ii) The Company has paid all amounts owed to the Investor pursuant to this Agreement.  This Agreement may be terminated at any time by the mutual written consent of the parties, effective as of the date of such mutual written consent unless otherwise provided in such written consent.  In the event of any termination of this Agreement by the Company hereunder, so long as the Investor owns any shares of Common Stock issued hereunder, unless all of such shares of Common Stock may be resold by the Investor without registration and without any time, volume or manner limitations pursuant to Rule 144, the Company shall not suspend (except as provided for in the Registration Rights Agreement) or withdraw the Registration Statement or otherwise cause the Registration Statement to become ineffective, or voluntarily delist the Common Stock from, the Principal Market without listing the Common Stock on another Principal Market.

 

(c)               The obligation of the Investor to make an Advance to the Company pursuant to this Agreement shall terminate permanently (including with respect to an Advance Date that

 



 

has not yet occurred) in the event that (i) there shall occur any stop order or suspension of the effectiveness of the Registration Statement for an aggregate of 50 Trading Days, other than due to the acts of the Investor, during the Commitment Period, or (ii) the Company shall at any time fail materially to comply with the requirements of Article VI and such failure is not cured within 30 days after receipt of written notice from the Investor, provided, however, that this termination provision shall not apply to any period commencing upon the filing of a post-effective amendment to such Registration Statement and ending upon the date on which such post effective amendment is declared effective by the SEC

 

(d)              Nothing in this  shall be deemed to release the Company or the Investor from any liability for any breach under this Agreement, or to impair the rights of the Company and the Investor to compel specific performance by the other party of its obligations under this Agreement.  The indemnification provisions contained in Sections 5.01 and 5.02 shall survive termination hereunder.

 

Article XI. Notices

 

Any notices, consents, waivers, or other communications required or permitted to be given under the terms of this Agreement must be in writing and will be deemed to have been delivered (i) upon receipt, when delivered personally; (ii) upon receipt, when sent by facsimile, provided a copy is mailed by U.S. certified mail, return receipt requested; (iii) 3 days after being sent by U.S. certified mail, return receipt requested, or (iv) 1 day after deposit with a nationally recognized overnight delivery service, in each case properly addressed to the party to receive the same.  The addresses and facsimile numbers for such communications, except for Advance Notices which shall be delivered in accordance with Section 2.02 hereof, shall be:

 

If to the Company, to:

 

Advanced Life Sciences Holdings, Inc.

 

 

1440 Davey Road

 

 

Woodridge, IL 60517

 

 

Attention:

General Counsel

 

 

Telephone:

(630) 739-6744

 

 

Facsimile:

(630) 739-6754

 

 

 

With a copy to:

 

Winston & Strawn LLP

 

 

35 W. Wacker Drive

 

 

Chicago, IL 60601

 

 

Attention:

R. Cabell Morris

 

 

Telephone:

(312) 558-5609

 

 

Facsimile:

(312) 558-5700

 



 

If to the Investor(s):

 

YA Global Investments, LP

 

 

101 Hudson Street –Suite 3700

 

 

Jersey City, NJ 07302

 

 

Attention:

Mark Angelo

 

 

 

Portfolio Manager

 

 

Telephone:

(201) 985-8300

 

 

Facsimile:

(201) 985-8266

 

 

 

With a Copy to:

 

David Gonzalez, Esq.

 

 

101 Hudson Street – Suite 3700

 

 

Jersey City, NJ 07302

 

 

Telephone:

(201) 985-8300

 

 

Facsimile:

(201) 985-8266

 

Each party shall provide 5 days’ prior written notice to the other party of any change in address or facsimile number.

 

Article XII. Miscellaneous

 

Section 12.01                          Counterparts.  This Agreement may be executed in two or more identical counterparts, all of which shall be considered one and the same agreement and shall become effective when counterparts have been signed by each party and delivered to the other party.  In the event any signature page is delivered by facsimile transmission, the party using such means of delivery shall cause 4 additional original executed signature pages to be physically delivered to the other party within 5 days of the execution and delivery hereof, though failure to deliver such copies shall not affect the validity of this Agreement.

 

Section 12.02                          Entire Agreement; Amendments.  This Agreement supersedes all other prior oral or written agreements between the Investor, the Company, their affiliates and persons acting on their behalf with respect to the matters discussed herein, and this Agreement and the instruments referenced herein contain the entire understanding of the parties with respect to the matters covered herein and therein and, except as specifically set forth herein or therein, neither the Company nor the Investor makes any representation, warranty, covenant or undertaking with respect to such matters.  No provision of this Agreement may be waived or amended other than by an instrument in writing signed by the party to be charged with enforcement.

 

Section 12.03                          Reporting Entity for the Common Stock.  The reporting entity relied upon for the determination of the trading price or trading volume of the Common Stock on any given Trading Day for the purposes of this Agreement shall be Bloomberg, L.P. or any successor thereto.  The written mutual consent of the Investor and the Company shall be required to employ any other reporting entity.

 

Section 12.04                          Fees and Expenses.  The Company hereby agrees to pay the following fees:

 



 

(a)               Structuring and Due Diligence Fee.  Each of the parties shall pay its own fees and expenses (including the fees of any attorneys, accountants, appraisers or others engaged by such party) in connection with this Agreement and the transactions contemplated hereby, except that (i) the Company shall pay a structuring and due diligence fee of $25,000 to Yorkville Advisors, LLC, of which $10,000 has been paid and the remaining $15,000 shall be paid on the date hereof, and (ii) On each Advance Date, the Company shall pay Yorkville Advisors, LLC a structuring fee of $500 directly out the gross proceeds of each Advance.

 

(b)              Commitment Fees.  Upon the execution of this Agreement the Company shall issue to the Investor shares of Common Stock in an amount equal to $300,000 divided by the VWAP of the Common Stock on the last full Trading Day prior to the date hereof (the “Investor’s Shares”). The Investor’s Shares shall be deemed fully earned as of the date hereof regardless of the amount of Advances, if any, that the Company is able to, or choices to, request hereunder.  The Investor’s Shares shall be deemed fully earned as of the date hereof.

 

Section 12.05                          Brokerage.  Each of the parties hereto represents that it has had no dealings in connection with this transaction with any finder or broker who will demand payment of any fee or commission from the other party.  The Company on the one hand, and the Investor, on the other hand, agree to indemnify the other against and hold the other harmless from any and all liabilities to any person claiming brokerage commissions or finder’s fees on account of services purported to have been rendered on behalf of the indemnifying party in connection with this Agreement or the transactions contemplated hereby.

 

Section 12.06                          Confidentiality.  If for any reason the transactions contemplated by this Agreement are not consummated, each of the parties hereto shall keep confidential any information obtained from any other party (except information publicly available or in such party’s domain prior to the date hereof, and except as required by court order) and shall promptly return to the other parties all schedules, documents, instruments, work papers or other written information without retaining copies thereof, previously furnished by it as a result of this Agreement or in connection herein.

 

[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]

 



 

IN WITNESS WHEREOF, the parties hereto have caused this Standby Equity Distribution Agreement to be executed by the undersigned, thereunto duly authorized, as of the date first set forth above.

 

 

COMPANY:

 

ADVANCED LIFE SCIENCES HOLDINGS, INC.

 

 

 

By:

 /s/ Michael T. Flavin

 

Name: Michael T. Flavin, Ph.D

 

Title: Chief Executive Officer

 

 

 

 

 

INVESTOR:

 

YA GLOBAL INVESTMENTS, L.P.

 

 

 

By:

Yorkville Advisors, LLC

 

Its:

Investment Manager

 

 

 

By:

 /s/ Gerald Eicke

 

Name: Gerald Eicke

 

Title: Managing Member

 



 

EXHIBIT A

 

ADVANCE NOTICE

 

ADVANCED LIFE SCIENCES HOLDINGS, INC.

 

The undersigned,                                                hereby certifies, with respect to the sale of shares of Common Stock of ADVANCED LIFE SCIENCES HOLDINGS, INC. (the “Company”) issuable in connection with this Advance Notice, delivered pursuant to the Standby Equity Distribution Agreement (the “Agreement”), as follows:

 

1.                                       The undersigned is the duly elected                                                 of the Company.

 

2.                                       There are no fundamental changes to the information set forth in the Registration Statement which would require the Company to file a post effective amendment to the Registration Statement.

 

3.                                     The Company has performed in all material respects all covenants and agreements to be performed by the Company and has complied in all material respects with all obligations and conditions contained in this Agreement on or prior to the Advance Notice Date, and shall continue to perform in all material respects all covenants and agreements to be performed by the Company through the applicable Advance Date.  All conditions to the delivery of this Advance Notice are satisfied as of the date hereof.

 

4.                                       The undersigned hereby represents, warrants and covenants that it has made all filings (“SEC Filings”) required to be made by it pursuant to applicable securities laws (including, without limitation, all filings required under the Securities Exchange Act of 1934, which include Forms 10-Q or 10-QSB, 10-K or 10-KSB, 8-K, etc.).  No SEC Filings or other public disclosures made by the Company, including, without limitation, all press releases, analysts meetings and calls, etc. (collectively, the “Public Disclosures”) contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading.

 

5.                                       The Advance requested is                                                    .

 

The undersigned has executed this Certificate this             day of                                         .

 

 

ADVANCED LIFE SCIENCES HOLDINGS, INC.

 

 

 

 

 

By:

 

 

Name:

 

Title:

 

Please deliver this Advance Notice by mail or facsimile to:

YA Global Investments, LP

101 Hudson Street, Suite 3700, Jersey City, NJ 07302

Facsimile:    (201) 946-0851

 


EX-4.2 3 a08-24714_1ex4d2.htm EX-4.2

Exhibit 4.2

 

Execution Copy

 

REGISTRATION RIGHTS AGREEMENT

 

REGISTRATION RIGHTS AGREEMENT (this “Agreement”), dated as of the 29th day of September 2008 (this “Agreement”) between YA GLOBAL INVESTMENTS, L.P., a Cayman Islands exempt limited partnership (the “Investor”), and ADVANCED LIFE SCIENCES HOLDINGS, INC., a corporation organized and existing under the laws of the State of Delaware (the “Company”)

 

WHEREAS:

 

A.                                   In connection with the Standby Equity Distribution Agreement by and between the parties hereto of even date herewith (the “Standby Equity Distribution Agreement”), the Company has agreed, upon the terms and subject to the conditions of the Standby Equity Distribution Agreement, to issue and sell to the Investor that number of shares of the Company’s common stock, par value $0.01 per share (the “Common Stock”), which can be purchased pursuant to the terms of the Standby Equity Distribution Agreement for an aggregate purchase price of up to $15,000,000.  Capitalized terms not defined herein shall have the meaning ascribed to them in the Standby Equity Distribution Agreement.

 

B.                                     To induce the Investor to execute and deliver the Standby Equity Distribution Agreement, the Company has agreed to provide certain registration rights under the Securities Act of 1933, as amended, and the rules and regulations thereunder, or any similar successor statute (collectively, the “Securities Act”), and applicable state securities laws.

 

NOW, THEREFORE, in consideration of the premises and the mutual covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Company and the Investor hereby agree as follows:

 

1.                                       DEFINITIONS.

 

As used in this Agreement, the following terms shall have the following meanings:

 

a.                                       Commitment Period” has the meaning given thereto in the Standby Equity Distribution Agreement.

 

b.                                      Person” means a corporation, a limited liability company, an association, a partnership, an organization, a business, an individual, a governmental or political subdivision thereof or a governmental agency.

 

c.                                       Prospectus” means the prospectus included in a Registration Statement (including, without limitation, a prospectus that includes any information previously omitted from a prospectus filed as part of an effective registration statement in reliance upon Rule 430A promulgated under the Securities Act), as amended or supplemented by any prospectus supplement, with respect to the terms of the offering of any portion of the Registrable Securities covered by a Registration Statement, and all other amendments and supplements to the

 



 

Prospectus, including post-effective amendments, and all material incorporated by reference or deemed to be incorporated by reference in such Prospectus.

 

d.                                      Registrable Securities” means (i) the shares of Common Stock that are or may be purchased by the Investor pursuant to the Standby Equity Distribution Agreement, (ii) the Commitment Shares, and (iii) any securities issued or issuable with respect to any of the foregoing by way of exchange, stock dividend or stock split or in connection with a combination of shares, recapitalization, merger, consolidation or other reorganization or otherwise.  As to any particular Registrable Securities, once issued such securities shall cease to be Registrable Securities when (a) the Registration Statement has been declared effective by the Commission and such Registrable Securities have been disposed of pursuant to the Registration Statement, (b) such Registrable Securities have been sold under circumstances under which all of the applicable conditions of Rule 144 (or any similar provision then in force) under the Securities Act (“Rule 144”) are met, or (c) in the opinion of counsel to the Company such Registrable Securities may permanently be sold without registration and without any time, volume or manner limitations pursuant to Rule 144.

 

e.                                       Registration Statement” means the registration statements required to be filed hereunder and any additional registration statements contemplated by Section 2 hereof, including (in each case) the Prospectus, amendments and supplements to such registration statement or Prospectus, including pre- and post-effective amendments, all exhibits thereto, and all material incorporated by reference or deemed to be incorporated by reference in such registration statement.

 

f.                                         Rule 415” means Rule 415 promulgated by the SEC pursuant to the Securities Act, as such Rule may be amended from time to time, or any similar rule or regulation hereafter adopted by the SEC  having substantially the same purpose and effect as such Rule.

 

g.                                      SEC” means the United States Securities and Exchange Commission.

 

2.                                       REGISTRATION.

 

a.                                       Filing of a Registration Statement.  The Company shall prepare and file with the SEC a Registration Statement, or multiple Registration Statements, on Form S-1 (or if the Company is then eligible, on Form S-3) for the resale by the Investor of the Registrable Securities.  The Company in its sole discretion may chose when to file such Registration Statements, provided however, pursuant to the Standby Equity Distribution Agreement the Company shall not have the ability to make any Advances until the effectiveness of a Registration Statement.  Each Registration Statement shall contain the “Plan of Distribution” section in substantially the form attached hereto as Exhibit A and contain all the required disclosures set forth on Exhibit B.

 

b.                                      Maintaining a Registration Statement.  The Company shall use all commercially reasonable efforts to cause any Registration Statement that has been declared effective to remain effective at all times until all Registrable Securities contained in such

 



 

Registration Statement cease to be Registrable Securities (the “Registration Period”).  Each Registration Statement (including any amendments or supplements thereto and prospectuses contained therein) shall not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein, or necessary to make the statements therein, in light of the circumstances in which they were made, not misleading.

 

3.                                       RELATED OBLIGATIONS.

 

a.                                       The Company shall, not less than 3 business days prior to the filing of a Registration Statement and not less than 1 business day prior to the filing of any related amendments and supplements to all Registration Statements (except for the filing of its reports under the Exchange Act), furnish to the Investor copies of all such documents proposed to be filed, which documents (other than those incorporated or deemed to be incorporated by reference) will be subject to the reasonable and prompt review of the Investor. The Company shall not file a Registration Statement or any such Prospectus or any amendments or supplements thereto to which the Investors shall reasonably object in good faith; provided that, the Company is notified of such objection in writing no later than two business days after the Investors have been so furnished copies of a Registration Statement.

 

b.                                      The Company shall (i) prepare and file with the SEC such amendments (including post-effective amendments) and supplements to a Registration Statement and the Prospectus used in connection with such Registration Statement, which prospectus is to be filed pursuant to Rule 424 promulgated under the Securities Act, as may be necessary to keep such Registration Statement effective at all times during the Registration Period, and prepare and file with the SEC such additional Registration Statements in order to register for resale under the Securities Act all of the Registrable Securities; (ii) cause the related Prospectus to be amended or supplemented by any required Prospectus supplement (subject to the terms of this Agreement), and as so supplemented or amended to be filed pursuant to Rule 424; (iii) respond as promptly as reasonably possible to any comments received from the SEC with respect to a Registration Statement or any amendment thereto and as promptly as reasonably possible provide the Investors true and complete copies of all correspondence from and to the SEC relating to a Registration Statement other than correspondence relating to any reports filed by the Company under the Exchange Act, provided that the Company may excise any information contained therein which would constitute material non-public information as to any Investor which has not executed a confidentiality agreement with the Company; and (iv) comply with the provisions of the Securities Act with respect to the disposition of all Registrable Securities of the Company covered by such Registration Statement until such time as all of such Registrable Securities shall have been disposed of in accordance with the intended methods of disposition by the seller or sellers thereof as set forth in such Registration Statement.  In the case of amendments and supplements to a Registration Statement which are required to be filed pursuant to this Agreement (including pursuant to this Section 3(b)) by reason of the Company’s filing a report on Form 10-K, Form 10-Q, or Form 8-K or any analogous report under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), the Company shall incorporate such report by reference into the Registration Statement, if applicable, or shall file such amendments or supplements with the SEC on the same day on which the Exchange Act report is filed which created the requirement for the Company to amend or supplement the Registration Statement.

 



 

c.                                       The Company shall furnish to the Investor without charge, (i) at least one copy of such Registration Statement as declared effective by the SEC and any amendment(s) thereto, including financial statements and schedules, all documents incorporated therein by reference, all exhibits and each preliminary prospectus, (ii) 10 copies of the final prospectus included in such Registration Statement and all amendments and supplements thereto (or such other number of copies as the Investor may reasonably request) and (iii) such other documents as the Investor may reasonably request from time to time as necessary for the disposition of the Registrable Securities owned by the Investor.

 

d.                                      The Company shall use its reasonable best efforts to (i) register and qualify the Registrable Securities covered by a Registration Statement under such other securities or “blue sky” laws of such jurisdictions in the United States as the Investor reasonably requests, (ii) prepare and file in those jurisdictions, such amendments (including post-effective amendments) and supplements to such registrations and qualifications as may be necessary to maintain the effectiveness thereof during the Registration Period, (iii) take such other actions as may be necessary to maintain such registrations and qualifications in effect at all times during the Registration Period, and (iv) take all other actions reasonably necessary or advisable to qualify the Registrable Securities for sale in such jurisdictions; provided, however, that the Company shall not be required in connection therewith or as a condition thereto to (w) make any change to its certificate of incorporation or by-laws, (x) qualify to do business in any jurisdiction where it would not otherwise be required to qualify but for this Section 3(d), (y) subject itself to general taxation in any such jurisdiction, or (z) file a general consent to service of process in any such jurisdiction.  The Company shall promptly notify the Investor of the receipt by the Company of any notification with respect to the suspension of the registration or qualification of any of the Registrable Securities for sale under the securities or “blue sky” laws of any jurisdiction in the United States or its receipt of actual notice of the initiation or threat of any proceeding for such purpose.

 

e.                                       As promptly as practicable after becoming aware of such event or development, the Company shall notify the Investor in writing of the happening of any event as a result of which the prospectus included in a Registration Statement, as then in effect, includes an untrue statement of a material fact or omission to state a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading (provided that in no event shall such notice contain any material, nonpublic information), and promptly prepare a supplement or amendment to such Registration Statement to correct such untrue statement or omission, and deliver 10 copies of such supplement or amendment to the Investor unless such supplement or amendment is achieved through incorporation by reference of a report filed under the Exchange Act.  Except for the filing of reports under the Exchange Act, the Company shall also promptly notify the Investor in writing (i) when a prospectus or any prospectus supplement or post-effective amendment has been filed, and when a Registration Statement or any post-effective amendment has become effective (notification of such effectiveness shall be delivered to the Investor by facsimile on the same day of such effectiveness), (ii) of any request by the SEC for amendments or supplements to a Registration Statement or related prospectus or related information, and (iii) of the Company’s reasonable determination that a post-effective amendment to a Registration Statement would be appropriate.

 



 

f.                                         The Company shall use its reasonable best efforts to prevent the issuance of any stop order or other suspension of effectiveness of a Registration Statement, or the suspension of the qualification of any of the Registrable Securities for sale in any jurisdiction within the United States of America and, if such an order or suspension is issued, to obtain the withdrawal of such order or suspension at the earliest possible moment and to notify the Investor of the issuance of such order and the resolution thereof or its receipt of actual notice of the initiation or threat of any proceeding for such purpose.

 

g.                                      If, after the execution of this Agreement, the Investor believes, after consultation with its legal counsel, that it could reasonably be deemed to be an underwriter (other than a statutory underwriter) of Registrable Securities, at the request of the Investor, the Company shall furnish to the Investor, on the date of the effectiveness of the Registration Statement and thereafter from time to time on such dates as the Investor may reasonably request (i) a letter, dated such date, from the Company’s independent certified public accountants in form and substance as is customarily given by independent certified public accountants to underwriters in an underwritten public offering, and (ii) an opinion, dated as of such date, of counsel representing the Company for purposes of such Registration Statement, in form, scope and substance as is customarily given in an underwritten public offering, addressed to the Investor.

 

h.                                      If, after the execution of this Agreement, the Investor believes, after consultation with its legal counsel, that it could reasonably be deemed to be an underwriter (other than a statutory underwriter) of Registrable Securities, at the request of the Investor, the Company shall make available for inspection by (i) the Investor and (ii)  one firm of accountants or other agents retained by the Investor (collectively, the “Inspectors”) all pertinent financial and other records, and pertinent corporate documents and properties of the Company (collectively, the “Records”), as shall be reasonably deemed necessary by each Inspector, and cause the Company’s officers, directors and employees to supply all information which any Inspector may reasonably request; provided, however, that each Inspector shall agree, and the Investor hereby agrees, to hold in strict confidence and shall not make any disclosure (except to an Investor) or use  any Record or other information which the Company determines in good faith to be confidential, and of which determination the Inspectors are so notified, unless (a) the disclosure of such Records is necessary to avoid or correct a misstatement or omission in any Registration Statement or is otherwise required under the Securities Act, (b) the release of such Records is ordered pursuant to a final, non-appealable subpoena or order from a court or government body of competent jurisdiction, or (c) the information in such Records has been made generally available to the public other than by disclosure in violation of this or any other agreement of which the Inspector and the Investor has knowledge.  The Investor agrees that it shall, upon learning that disclosure of such Records is sought in or by a court or governmental body of competent jurisdiction or through other means, give prompt notice to the Company and allow the Company, at its expense, to undertake appropriate action to prevent disclosure of, or to obtain a protective order for, the Records deemed confidential.

 

i.                                          The Company shall hold in confidence and not make any disclosure of information concerning the Investor provided to the Company unless (i) disclosure of such information is necessary to comply with federal or state securities laws, (ii) the disclosure of such information is necessary to avoid or correct a misstatement or omission in any

 



 

Registration Statement, (iii) the release of such information is ordered pursuant to a subpoena or other order from a court or governmental body of competent jurisdiction, or (iv) such information has been made generally available to the public other than by disclosure in violation of this Agreement or any other agreement.  The Company agrees that it shall, upon learning that disclosure of such information concerning the Investor is sought in or by a court or governmental body of competent jurisdiction or through other means, give prompt written notice to the Investor and allow the Investor, at the Investor’s expense, to undertake appropriate action to prevent disclosure of, or to obtain a protective order for, such information.

 

j.                                          The Company shall use its reasonable best efforts either to cause all the Registrable Securities covered by a Registration Statement (i) to be listed on each securities exchange on which securities of the same class or series issued by the Company are then listed, if any, if the listing of such Registrable Securities is then permitted under the rules of such exchange or to secure the inclusion for quotation on the National Association of Securities Dealers, Inc. OTC Bulletin Board for such Registrable Securities.  The Company shall pay all fees and expenses in connection with satisfying its obligation under this Section 3(j).

 

k.                                       The Company shall cooperate with the Investor, to the extent applicable, to facilitate the timely preparation and delivery of certificates (not bearing any restrictive legend) representing the Registrable Securities to be offered pursuant to a Registration Statement and enable such certificates to be in such denominations or amounts, as the case may be, as the Investor may reasonably request and registered in such names as the Investor may request.

 

l.                                          The Company shall use its reasonable best efforts to cause the Registrable Securities covered by the applicable Registration Statement to be registered with or approved by such other governmental agencies or authorities as may be necessary to consummate the disposition of such Registrable Securities.

 

m.                                    The Company shall otherwise use its reasonable best efforts to comply with all applicable rules and regulations of the SEC in connection with any registration hereunder.

 

n.                                      Within 2 business days after a Registration Statement which covers Registrable Securities is ordered effective by the SEC, the Company shall deliver, and shall cause legal counsel for the Company to deliver, to the transfer agent for such Registrable Securities (with copies to the Investor) confirmation that such Registration Statement has been declared effective by the SEC in the form attached hereto as Exhibit C.

 

o.                                      The Company shall take all other reasonable actions necessary to expedite and facilitate disposition by the Investor of Registrable Securities pursuant to a Registration Statement.

 

4.                                       OBLIGATIONS OF THE INVESTOR.

 

a.                                       The Investor agrees that, upon receipt of any notice from the Company of the (i) the happening of any event, following which the prospectus included in a Registration Statement, as then in effect, includes an untrue statement of a material fact or omits to state a

 



 

material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading, or (ii) the issuance of any stop order or other suspension of effectiveness of a Registration Statement, or the suspension of the qualification of any of the Registrable Securities for sale in any jurisdiction within the United States of America, the Investor will immediately discontinue disposition of Registrable Securities pursuant to any Registration Statement(s) covering such Registrable Securities until the Investor’s receipt of written notice from the Company indicating that such event has been cured and confirming that re-sales may be made pursuant to such Registration Statement.  Notwithstanding anything to the contrary, the Company shall cause its transfer agent to deliver unlegended certificates for shares of Common Stock to a transferee of the Investor in accordance with the terms of the Standby Equity Distribution Agreement in connection with any sale of Registrable Securities with respect to which the Investor has entered into a contract for sale prior to the Investor’s receipt of a notice from the Company described in this section and for which the Investor has not yet settled.

 

b.                                      The Investor covenants and agrees that it will comply with the prospectus delivery requirements of the Securities Act as applicable to it or an exemption therefrom in connection with sales of Registrable Securities pursuant to the Registration Statement.

 

5.                                       EXPENSES OF REGISTRATION.

 

All expenses of the Company incurred in connection with registrations, filings or qualifications pursuant to Sections 2 and 3, including, without limitation, all registration, listing and qualifications fees, printers, legal and accounting fees shall be paid by the Company.

 

6.                                       INDEMNIFICATION.

 

With respect to Registrable Securities which are included in a Registration Statement under this Agreement:

 

a.                                       To the fullest extent permitted by law, the Company will, and hereby does, indemnify, hold harmless and defend the Investor, the directors, officers, partners, employees, agents, representatives of, and each Person, if any, who controls the Investor within the meaning of the Securities Act or the Exchange Act (each, an “Indemnified Person”), against any losses, claims, damages, liabilities, judgments, fines, penalties, charges, costs, reasonable attorneys’ fees, amounts paid in settlement or expenses, joint or several (collectively, “Claims”) incurred in investigating, preparing or defending any action, claim, suit, inquiry, proceeding, investigation or appeal taken from the foregoing by or before any court or governmental, administrative or other regulatory agency, body or the SEC, whether pending or threatened, whether or not an indemnified party is or may be a party thereto (“Indemnified Damages”), to which any of them may become subject insofar as such Claims (or actions or proceedings, whether commenced or threatened, in respect thereof) arise out of or are based upon: (i) any untrue statement or alleged untrue statement of a material fact in a Registration Statement or any post-effective amendment thereto or in any filing made in connection with the qualification of the offering under the securities or other “blue sky” laws of any jurisdiction in which Registrable Securities are offered (“Blue Sky Filing”), or the omission or alleged omission to state a material fact required to be stated therein or necessary to make the statements therein not misleading;

 



 

(ii) any untrue statement or alleged untrue statement of a material fact contained in any final prospectus (as amended or supplemented, if the Company files any amendment thereof or supplement thereto with the SEC) or the omission or alleged omission to state therein any material fact necessary to make the statements made therein, in light of the circumstances under which the statements therein were made, not misleading; or (iii) any violation or alleged violation by the Company of the Securities Act, the Exchange Act, any other law, including, without limitation, any state securities law, or any rule or regulation there under relating to the offer or sale of the Registrable Securities pursuant to a Registration Statement (the matters in the foregoing clauses (i) through (iii) being, collectively, “Violations”).  The Company shall reimburse the Investor and each such controlling person promptly as such expenses are incurred and are due and payable, for any legal fees or disbursements or other reasonable expenses incurred by them in connection with investigating or defending any such Claim.  Notwithstanding anything to the contrary contained herein, the indemnification agreement contained in this Section 6(a): (x) shall not apply to a Claim by an Indemnified Person arising out of or based upon a Violation which occurs in reliance upon and in conformity with information furnished in writing to the Company by such Indemnified Person expressly for use in connection with the preparation of the Registration Statement or any such amendment thereof or supplement thereto; (y) shall not be available to the extent such Claim is based on a failure of the Investor to deliver or to cause to be delivered the prospectus made available by the Company, if such prospectus was timely made available by the Company pursuant to Section 3(e); and (z) shall not apply to amounts paid in settlement of any Claim if such settlement is effected without the prior written consent of the Company, which consent shall not be unreasonably withheld.  Such indemnity shall remain in full force and effect regardless of any investigation made by or on behalf of the Indemnified Person and shall survive the transfer of the Registrable Securities by the Investor.

 

b.                                      In connection with a Registration Statement, the Investor agrees to indemnify, hold harmless and defend, to the same extent and in the same manner as is set forth in Section 6(a), the Company, each of its directors, each of its officers who signs the Registration Statement and each Person, if any, who controls the Company within the meaning of the Securities Act or the Exchange Act (each an “Indemnified Party”), against any Claim or Indemnified Damages to which any of them may become subject, under the Securities Act, the Exchange Act or otherwise, insofar as such Claim or Indemnified Damages arise out of or is based upon any Violation, in each case to the extent, and only to the extent, that such Violation occurs in reliance upon and in conformity with written information furnished to the Company by the Investor expressly for use in connection with such Registration Statement; and, subject to Section 6(d), the Investor will reimburse any legal or other expenses reasonably incurred by them in connection with investigating or defending any such Claim; provided, however, that the indemnity agreement contained in this Section 6(b) and the agreement with respect to contribution contained in Section 7 shall not apply to amounts paid in settlement of any Claim if such settlement is effected without the prior written consent of the Investor, which consent shall not be unreasonably withheld; provided, further, however, that the Investor shall be liable under this Section 6(b) for only that amount of a Claim or Indemnified Damages as does not exceed the net proceeds to the Investor as a result of the sale of Registrable Securities pursuant to such Registration Statement.  Such indemnity shall remain in full force and effect regardless of any investigation made by or on behalf of such Indemnified Party and shall survive the transfer of the Registrable Securities by the Investor.  Notwithstanding anything to the contrary contained

 



 

herein, the indemnification agreement contained in this Section 6(b) with respect to any prospectus shall not inure to the benefit of any Indemnified Party if the untrue statement or omission of material fact contained in the prospectus was corrected and such new prospectus was delivered to the Investor prior to the Investor’s use of the prospectus to which the Claim relates.

 

c.                                       Promptly after receipt by an Indemnified Person or Indemnified Party under this Section 6 of notice of the commencement of any action or proceeding (including any governmental action or proceeding) involving a Claim, such Indemnified Person or Indemnified Party shall, if a Claim in respect thereof is to be made against any indemnifying party under this Section 6, deliver to the indemnifying party a written notice of the commencement thereof, and the indemnifying party shall have the right to participate in, and, to the extent the indemnifying party so desires, jointly with any other indemnifying party similarly noticed, to assume control of the defense thereof with counsel mutually satisfactory to the indemnifying party and the Indemnified Person or the Indemnified Party, as the case may be; provided, however, that an Indemnified Person or Indemnified Party shall have the right to retain its own counsel with the fees and expenses of not more than one counsel for such Indemnified Person or Indemnified Party to be paid by the indemnifying party, if, in the reasonable opinion of counsel retained by the indemnifying party, the representation by such counsel of the Indemnified Person or Indemnified Party and the indemnifying party would be inappropriate due to actual or potential differing  interests between such Indemnified Person or Indemnified Party and any other party represented by such counsel in such proceeding. The Indemnified Party or Indemnified Person shall cooperate fully with the indemnifying party in connection with any negotiation or defense of any such action or claim by the indemnifying party and shall furnish to the indemnifying party all information reasonably available to the Indemnified Party or Indemnified Person which relates to such action or claim.  The indemnifying party shall keep the Indemnified Party or Indemnified Person fully apprised at all times as to the status of the defense or any settlement negotiations with respect thereto.  No indemnifying party shall be liable for any settlement of any action, claim or proceeding effected without its prior written consent, provided, however, that the indemnifying party shall not unreasonably withhold, delay or condition its consent.  No indemnifying party shall, without the prior written consent of the Indemnified Party or Indemnified Person, consent to entry of any judgment or enter into any settlement or other compromise which does not include as an unconditional term thereof the giving by the claimant or plaintiff to such Indemnified Party or Indemnified Person of a release from all liability in respect to such claim or litigation.  Following indemnification as provided for hereunder, the indemnifying party shall be subrogated to all rights of the Indemnified Party or Indemnified Person with respect to all third parties, firms or corporations relating to the matter for which indemnification has been made.  The failure to deliver written notice to the indemnifying party within a reasonable time of the commencement of any such action shall not relieve such indemnifying party of any liability to the Indemnified Person or Indemnified Party under this Section 6, except to the extent that the indemnifying party is prejudiced in its ability to defend such action.

 

d.                                      The indemnification required by this Section 6 shall be made by periodic payments of the amount thereof during the course of the investigation or defense, as and when bills are received or Indemnified Damages are incurred.

 



 

e.                                       The indemnity agreements contained herein shall be in addition to (i) any cause of action or similar right of the Indemnified Party or Indemnified Person against the indemnifying party or others, and (ii) any liabilities the indemnifying party may be subject to pursuant to the law.

 

7.                                       CONTRIBUTION.

 

To the extent any indemnification by an indemnifying party is prohibited or limited by law, the indemnifying party agrees to make the maximum contribution with respect to any amounts for which it would otherwise be liable under Section 6 to the fullest extent permitted by law; provided, however, that: (i) no seller of Registrable Securities guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution from any seller of Registrable Securities who was not guilty of fraudulent misrepresentation; and (ii) contribution by any seller of Registrable Securities shall be limited in amount to the net amount of proceeds received by such seller from the sale of such Registrable Securities.

 

8.                                       REPORTS UNDER THE EXCHANGE ACT.

 

With a view to making available to the Investor the benefits of Rule 144 promulgated under the Securities Act or any similar rule or regulation of the SEC that may at any time permit the Investor to sell securities of the Company to the public without registration (“Rule 144”) the Company agrees to:

 

a.                                       make and keep public information available, as those terms are understood and defined in Rule 144;

 

b.                                      file with the SEC in a timely manner all reports and other documents required of the Company under the Securities Act and the Exchange Act so long as the Company remains subject to such requirements (it being understood that nothing herein shall limit the Company’s obligations under Section 6.3 of the Standby Equity Distribution Agreement) and the filing of such reports and other documents is required for the applicable provisions of Rule 144; and

 

c.                                       furnish to the Investor so long as the Investor owns Registrable Securities, promptly upon request, (i) a written statement by the Company that it has complied with the reporting requirements of Rule 144, the Securities Act and the Exchange Act, (ii) a copy of the most recent annual or quarterly report of the Company and such other reports and documents so filed by the Company, and (iii) such other information as may be reasonably requested to permit the Investor to sell such securities pursuant to Rule 144 without registration.

 

9.                                       AMENDMENT OF REGISTRATION RIGHTS.

 

Provisions of this Agreement may be amended and the observance thereof may be waived (either generally or in a particular instance and either retroactively or prospectively), only by a written agreement between the Company and the Investor.  Any amendment or waiver effected in accordance with this Section 9 shall be binding upon the Investor and the Company. 

 



 

No consideration shall be offered or paid to any Person to amend or consent to a waiver or modification of any provision of any of this Agreement unless the same consideration also is offered to all of the parties to this Agreement.

 

10.                                 MISCELLANEOUS.

 

a.                                       A Person is deemed to be a holder of Registrable Securities whenever such Person owns or is deemed to own of record such Registrable Securities.  If the Company receives conflicting instructions, notices or elections from two or more Persons with respect to the same Registrable Securities, the Company shall act upon the basis of instructions, notice or election received from the registered owner of such Registrable Securities.

 

b.                                      Any notices, consents, waivers or other communications required or permitted to be given under the terms of this Agreement must be in writing and will be deemed to have been delivered:  (i) upon receipt, when delivered personally; (ii) upon receipt, when sent by facsimile (provided confirmation of transmission is mechanically or electronically generated and kept on file by the sending party); or (iii) one business day after deposit with a nationally recognized overnight delivery service, in each case properly addressed to the party to receive the same.  The addresses and facsimile numbers for such communications shall be:

 

If to the Company, to:

Advanced Life Sciences Holdings, Inc.

 

1440 Davey Road

 

Woodridge, IL 60517

 

Attention:

General Counsel

 

Telephone:

(630) 739-6744

 

Facsimile:

(630) 739-6754

 

 

With a copy to:

Winston & Strawn LLP

 

35 W. Wacker Drive

 

Chicago, IL 60601

 

Attention:

R. Cabell Morris

 

Telephone:

(312) 558-5609

 

Facsimile:

(312) 558-5700

 

 

If to the Investor, to:

YA Global Investments, LP

 

101 Hudson Street – Suite 3700

 

Jersey City, New Jersey 07302

 

Attention:

Mark Angelo

 

 

Portfolio Manager

 

Telephone:

(201) 985-8300

 

Facsimile:

(201) 985-8266

 



 

With a copy to:

YA Global Investments, LP

 

101 Hudson Street – Suite 3700

 

Jersey City, NJ 07302

 

Attention:

David Gonzalez, Esq.

 

Telephone:

(201) 985-8300

 

Facsimile:

(201) 985-8266

 

Any party may change its address by providing written notice to the other parties hereto at least five days prior to the effectiveness of such change.  Written confirmation of receipt (A) given by the recipient of such notice, consent, waiver or other communication, (B) mechanically or electronically generated by the sender’s facsimile machine containing the time, date, recipient facsimile number and an image of the first page of such transmission or (C) provided by a courier or overnight courier service shall be rebuttable evidence of personal service, receipt by facsimile or receipt from a nationally recognized overnight delivery service in accordance with clause (i), (ii) or (iii) above, respectively.

 

c.                                       Failure of any party to exercise any right or remedy under this Agreement or otherwise, or delay by a party in exercising such right or remedy, shall not operate as a waiver thereof.

 

d.                                      The corporate laws of the State of New Jersey shall govern all issues concerning the relative rights of the Company and the Investor.  All other questions concerning the construction, validity, enforcement and interpretation of this Agreement shall be governed by the internal laws of the State of New Jersey, without giving effect to any choice of law or conflict of law provision or rule (whether of the State of New Jersey or any other jurisdiction) that would cause the application of the laws of any jurisdiction other than the State of New Jersey.  Each party hereby irrevocably submits to the non-exclusive jurisdiction of the Superior Courts of the State of New Jersey, sitting in Hudson County, New Jersey and the Federal District Court for the District of New Jersey sitting in Newark, New Jersey, for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein, and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, that such suit, action or proceeding is brought in an inconvenient forum or that the venue of such suit, action or proceeding is improper.  Each party hereby irrevocably waives personal service of process and consents to process being served in any such suit, action or proceeding by mailing a copy thereof to such party at the address for such notices to it under this Agreement and agrees that such service shall constitute good and sufficient service of process and notice thereof.  Nothing contained herein shall be deemed to limit in any way any right to serve process in any manner permitted by law.  If any provision of this Agreement shall be invalid or unenforceable in any jurisdiction, such invalidity or unenforceability shall not affect the validity or enforceability of the remainder of this Agreement in that jurisdiction or the validity or enforceability of any provision of this Agreement in any other jurisdiction.  EACH PARTY HEREBY IRREVOCABLY WAIVES ANY RIGHT IT MAY HAVE, AND AGREES NOT TO REQUEST, A JURY TRIAL FOR THE ADJUDICATION OF ANY DISPUTE HEREUNDER OR IN CONNECTION HEREWITH OR ARISING OUT OF THIS AGREEMENT OR ANY TRANSACTION CONTEMPLATED HEREBY.

 



 

e.                                       This Agreement, the Standby Equity Distribution Agreement and any related agreements constitute the entire agreement among the parties hereto with respect to the subject matter hereof and thereof.  There are no restrictions, promises, warranties or undertakings, other than those set forth or referred to herein and therein.  This Agreement, the Standby Equity Distribution Agreement and any related agreements supersede all prior agreements and understandings among the parties hereto with respect to the subject matter hereof and thereof.

 

f.                                         The headings in this Agreement are for convenience of reference only and shall not limit or otherwise affect the meaning hereof.

 

g.                                      This Agreement may be executed in identical counterparts, each of which shall be deemed an original but all of which shall constitute one and the same agreement.  This Agreement, once executed by a party, may be delivered to the other party hereto by facsimile transmission of a copy of this Agreement bearing the signature of the party so delivering this Agreement.

 

h.                                      Each party shall do and perform, or cause to be done and performed, all such further acts and things, and shall execute and deliver all such other agreements, certificates, instruments and documents, as the other party may reasonably request in order to carry out the intent and accomplish the purposes of this Agreement and the consummation of the transactions contemplated hereby.

 

i.                                          The language used in this Agreement will be deemed to be the language chosen by the parties to express their mutual intent and no rules of strict construction will be applied against any party.

 

j.                                          This Agreement is intended for the benefit of the parties hereto and their respective permitted successors and assigns, and is not for the benefit of, nor may any provision hereof be enforced by, any other Person.

 

[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]

 



 

IN WITNESS WHEREOF, the parties have caused this Registration Rights Agreement to be duly executed as of day and year first above written.

 

 

ADVANCED LIFE SCIENCES HOLDINGS, INC.

 

 

 

By:

/s/ Michael T. Flavin

 

Name: Michael T. Flavin, Ph.D

 

Title: Chief Executive Officer

 

 

 

 

 

YA GLOBAL INVESTMENTS, L.P.

 

 

 

By:

Yorkville Advisors, LLC

 

Its:

Investment Manager

 

 

 

By:

/s/ Gerald Eicke

 

Name: Gerald Eicke

 

Title: Managing Member

 



 

EXHIBIT A

 

PLAN OF DISTRIBUTION

 

Each Selling Stockholder (the “Selling Stockholders”) of the common stock and any of their pledgees, assignees and successors-in-interest may, from time to time, sell any or all of their shares of common stock on the                         or any other stock exchange, market or trading facility on which the shares are traded or in private transactions.  These sales may be at fixed or negotiated prices.  A Selling Stockholder may use any one or more of the following methods when selling shares:

 

·                  ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;

 

·                  block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction;

 

·                  purchases by a broker-dealer as principal and resale by the broker-dealer for its account;

 

·                  an exchange distribution in accordance with the rules of the applicable exchange;

 

·                  privately negotiated transactions;

 

·                  broker-dealers may agree with the Selling Stockholders to sell a specified number of such shares at a stipulated price per share;

 

·                  through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;

 

·                  a combination of any such methods of sale; or

 

·                  any other method permitted pursuant to applicable law.

 

The Selling Stockholders may also sell shares under Rule 144 under the Securities Act of 1933, as amended (the “Securities Act”), if available, rather than under this prospectus.

 

Broker-dealers engaged by the Selling Stockholders may arrange for other brokers-dealers to participate in sales.  Broker-dealers may receive commissions or discounts from the Selling Stockholders (or, if any broker-dealer acts as agent for the purchaser of shares, from the purchaser) in amounts to be negotiated, but, except as set forth in a supplement to this Prospectus, in the case of an agency transaction not in excess of a customary brokerage commission in compliance with NASDR Rule 2440; and in the case of a principal transaction a markup or markdown in compliance with NASDR IM-2440.

 



 

In connection with the sale of the common stock or interests therein, the Selling Stockholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the Common Stock in the course of hedging the positions they assume.  The Selling Stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or the creation of one or more derivative securities which require the delivery to such broker-dealer or other financial institution of shares offered by this prospectus, which shares such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).

 

The Selling Stockholders and any broker-dealers or agents that are involved in selling the shares may be deemed to be “underwriters” within the meaning of the Securities Act in connection with such sales.  In such event, any commissions received by such broker-dealers or agents and any profit on the resale of the shares purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act.  Each Selling Stockholder has informed the Company that it does not have any written or oral agreement or understanding, directly or indirectly, with any person to distribute the Common Stock. In no event shall any broker-dealer receive fees, commissions and markups which, in the aggregate, would exceed eight percent (8%).

 

The Company is required to pay certain fees and expenses incurred by the Company incident to the registration of the shares.  The Company has agreed to indemnify the Selling Stockholders against certain losses, claims, damages and liabilities, including liabilities under the Securities Act.

 

Because Selling Stockholders may be deemed to be “underwriters” within the meaning of the Securities Act, they will be subject to the prospectus delivery requirements of the Securities Act including Rule 172 thereunder.  In addition, any securities covered by this prospectus which qualify for sale pursuant to Rule 144 under the Securities Act may be sold under Rule 144 rather than under this prospectus.  There is no underwriter or coordinating broker acting in connection with the proposed sale of the resale shares by the Selling Stockholders.

 

We agreed to keep this prospectus effective until the earlier of (i) the date on which the shares may be resold by the Selling Stockholders without registration and without regard to any volume limitations by reason of Rule 144 under the Securities Act or any other rule of similar effect or (ii) all of the shares have been sold pursuant to this prospectus or Rule 144 under the Securities Act or any other rule of similar effect.  The resale shares will be sold only through registered or licensed brokers or dealers if required under applicable state securities laws. In addition, in certain states, the resale shares may not be sold unless they have been registered or qualified for sale in the applicable state or an exemption from the registration or qualification requirement is available and is complied with.

 

Under applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale shares may not simultaneously engage in market making activities with respect to the common stock for the applicable restricted period, as defined in Regulation M, prior to the commencement of the distribution.  In addition, the Selling Stockholders will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder,

 



 

including Regulation M, which may limit the timing of purchases and sales of shares of the common stock by the Selling Stockholders or any other person.  We will make copies of this prospectus available to the Selling Stockholders and have informed them of the need to deliver a copy of this prospectus to each purchaser at or prior to the time of the sale (including by compliance with Rule 172 under the Securities Act).

 



 

EXHIBIT B

 

OTHER DISCLOSURES

 

See attachment provided separately.

 



 

EXHIBIT C

FORM OF NOTICE OF EFFECTIVENESS
OF REGISTRATION STATEMENT

 

Attention:

 

Re:                               ADVANCED LIFE SCIENCE HOLDINGS, INC.

 

Ladies and Gentlemen:

 

We are counsel to Advanced Life Science Holdings, Inc. (the “Company”), and have represented the Company in connection with that certain Standby Equity Distribution Agreement (the “Standby Equity Distribution Agreement”) entered into by and between the Company and YA Global Investments, LP (the “Investor”) pursuant to which the Company issued to the Investor shares of its Common Stock, par value $0.01 per share (the “Common Stock”).  Pursuant to the Standby Equity Distribution Agreement, the Company also has entered into a Registration Rights Agreement with the Investor (the “Registration Rights Agreement”) pursuant to which the Company agreed, among other things, to register the Registrable Securities (as defined in the Registration Rights Agreement) under the Securities Act of 1933, as amended (the “Securities Act”).  In connection with the Company’s obligations under the Registration Rights Agreement, on                                  , the Company filed a Registration Statement on Form                  (File No. 333-                          ) (the “Registration Statement”) with the Securities and Exchange Commission (the “SEC”) relating to the Registrable Securities which names the Investor as a selling stockholder thereunder.

 

In connection with the foregoing, we advise you that a member of the SEC’s staff has advised us by telephone that the SEC has entered an order declaring the Registration Statement effective under the Securities Act at [ENTER TIME OF EFFECTIVENESS] on [ENTER DATE OF EFFECTIVENESS] and we have no knowledge, after telephonic inquiry of a member of the SEC’s staff, that any stop order suspending its effectiveness has been issued or that any proceedings for that purpose are pending before, or threatened by, the SEC and the Registrable Securities are available for resale under the Securities Act pursuant to the Registration Statement.

 

 

Very truly yours,

 

 

 

 

 

By:

 

 

 

cc:

YA Global Investments, L.P.

 

 


EX-4.3 4 a08-24714_1ex4d3.htm EX-4.3

Exhibit 4.3

 

EXECUTION COPY

 

STOCK PURCHASE AGREEMENT

 

THIS STOCK PURCHASE AGREEMENT (this “Agreement”) is entered into as of this 29th day of September, 2008 by and between ADVANCED LIFE SCIENCES HOLDINGS, INC., a Delaware corporation (the “Company”), and WYETH, a Delaware corporation  (the “Investor”).

 

RECITALS

 

WHEREAS, the Company and the Investor have entered into that certain Development and Commercialization Agreement, dated as of the date hereof, pursuant to which the Company granted the Investor the exclusive right and license to develop and commercialize cethromycin and all pharmaceutically acceptable forms thereof in the geographical territory specified therein, subject to the terms and conditions thereof (the “License Agreement”); and

 

WHEREAS, in connection with the execution and delivery of the License Agreement, the Company desires to sell, and the Investor agrees to purchase, shares of the Company’s common stock, $0.01 par value per share (the “Common Stock”), all subject to the terms and conditions set forth below;

 

NOW, THEREFORE, in consideration of the foregoing Recitals and the mutual agreements and covenants contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Company and the Investor hereby agree as follows:

 

ARTICLE I

PURCHASE AND SALE OF THE SHARES

 

1.1           Purchase and Sale.  The Company and the Investor agree that, at the Closing (as defined below), the Investor will purchase from the Company, and the Company will issue and sell to the Investor, 1,888,606 shares of the Common Stock (the “Shares”).  The purchase price payable by the Investor to the Company at the Closing shall be equal to $0.908 per Share, which represents the average of the closing prices of the Common Stock on the Nasdaq Capital Market (“Nasdaq”) over the eighteen (18) trading day period ending on the last trading day prior to the date hereof, or an aggregate of $1,714,854.25 for all the Shares (the “Purchase Price”).

 

1.2           Delivery of the Shares at Closing.  It is expected that the completion of the purchase and sale of the Shares (the “Closing”) shall occur on or about September 29, 2008 (the “Closing Date”), at the Chicago offices of the Company’s outside legal counsel, Winston & Strawn LLP.  At the Closing, the Company shall deliver to the Investor one or more stock certificates representing the Shares, each such certificate to be registered in the name of the Investor.

 

1.3           Conditions to the Company’s Obligations.  The Company’s obligation to issue the Shares to the Investor shall be subject to the following conditions, any one or more of which may be waived by the Company: (a) the License Agreement shall have become effective according to its terms; (b) receipt by the Company of a certified or official bank check or wire transfer of funds in the full amount of the Purchase Price; and (c) the accuracy in all material respects of the representations and warranties made by the Investor when made and the fulfillment in all material respects of those undertakings of the Investor to be fulfilled prior to the Closing.

 

1.4           Conditions to the Investor’s Obligations.  The Investor’s obligation to purchase the Shares shall be subject to the following conditions, any one or more of which may be waived by the

 



 

Investor: (a) the License Agreement shall have become effective according to its terms; (b) the representations and warranties of the Company set forth herein shall be true and correct as of the Closing Date (except for representations and warranties that speak as of a specific date, which representations and warranties shall be true and correct as of such date) in all material respects (except for representations that are qualified by materiality, which shall be true and correct in all respects) and the fulfillment of those undertakings of the Company in this Agreement to be fulfilled on or prior to the Closing Date; and (c) the Investor shall have received a legal opinion from the Company’s outside legal counsel, Winston & Strawn LLP, as to the matters set forth on Exhibit A attached hereto.

 

ARTICLE II

REPRESENTATIONS, WARRANTIES AND COVENANTS OF THE COMPANY

 

The Company hereby represents and warrants to, and covenants with, the Investor, as follows:

 

2.1             Organization.  The Company is duly organized and validly existing in good standing under the laws of the State of Delaware.  The Company has full power and authority to own or lease its properties and to conduct its business as presently conducted and as described in the documents filed by the Company under the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder (the “Securities Act”) and the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder (the “Exchange Act”) since the end of its most recently completed fiscal year through the date hereof (collectively, the “SEC Documents”) and is registered or qualified to do business and in good standing in each jurisdiction in which the nature of the business conducted by it or the location of the properties owned or leased by it requires such qualification and where the failure to be so qualified would have a material adverse effect upon the condition (financial or otherwise), operations (including results thereof), business or properties of the Company or on the transactions contemplated by this Agreement (a “Material Adverse Effect”), and no proceeding has been instituted in any such jurisdiction, revoking, limiting or curtailing, or seeking to revoke, limit or curtail, such power and authority or qualification.  Other than Advanced Life Sciences, Inc., the Company has no subsidiaries (as defined in Rule 405 of the Securities Act).

 

2.2             Due Authorization and Valid Issuance.  The Company has all requisite corporate power and authority to execute, deliver and perform its obligations under this Agreement, and this Agreement has been duly authorized and validly executed and delivered by the Company and constitutes the legal, valid and binding agreement of the Company enforceable against the Company in accordance with its terms, except as rights to indemnity and contribution may be limited by state or federal securities laws or the public policy underlying such laws, except as enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ and contracting parties’ rights generally and except as enforceability may be subject to general principles of equity (regardless of whether such enforceability is considered in a proceeding in equity or at law).  The Shares, when issued pursuant to this Agreement, upon receipt of the agreed consideration therefor, will be duly authorized, validly issued, fully-paid and nonassessable.

 

2.3             Non-Contravention.  The execution and delivery of this Agreement, the issuance and sale of the Shares under this Agreement, the fulfillment of the terms of this Agreement and the consummation of the transactions contemplated hereby will not (A) conflict with or constitute a violation of, or default (with the passage of time or otherwise) under, (i) any bond, debenture, note or other evidence of indebtedness, lease, contract, indenture, mortgage, deed of trust, loan agreement, joint venture or other agreement or instrument to which the Company is a party or by which it or its properties are bound, (ii) the charter, by-laws or other organizational documents of the Company, or (iii) any law, administrative regulation, ordinance or order of any court or governmental agency, arbitration panel or authority applicable

 

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to the Company or its properties, except in the case of clauses (i) and (iii) for any such conflicts, violations or defaults that are not reasonably likely to have a Material Adverse Effect or (B) result in the creation or imposition of any lien, encumbrance, claim, security interest or restriction whatsoever upon any of the properties or assets of the Company or an acceleration of indebtedness pursuant to any obligation, agreement or condition contained in any bond, debenture, note or any other evidence of indebtedness or any indenture, mortgage, deed of trust or any other agreement or instrument to which the Company is a party or by which it is bound or to which any of the material property or assets of the Company is subject, except for such liens, encumbrances, claims, security interests or restrictions upon any of the properties or assets of the Company or accelerations of indebtedness that are not reasonably likely to have a Material Adverse Effect.  No consent, approval, authorization or other order of, or registration, qualification or filing with, any regulatory body, administrative agency, or other governmental body or any other person is required for the execution and delivery of this Agreement or the valid issuance and sale of the Shares, other than such as have been made or obtained, and except for any post-closing securities filings or notifications required to be made under federal or state securities laws.

 

2.4             Capitalization.  The capitalization of the Company as of June 30, 2008 is as set forth in the most recent applicable SEC Documents, increased as set forth in the next sentence.  The Company has not issued any capital stock since that date other than pursuant to (i) employee benefit plans disclosed in the SEC Documents, (ii) outstanding warrants, options or other securities disclosed in the SEC Documents and (iii) that certain Standby Equity Distribution Agreement (the “SEDA”) between the Company and YA Global Investments, L.P. dated on or about the date hereof, pursuant to which the Company has issued or will issue a number of shares equal to less than 1.0% of its outstanding Common Stock.  The outstanding shares of capital stock of the Company have been duly and validly issued and are fully paid and nonassessable, have been issued in compliance with all federal and state securities laws, and were not issued in violation of any preemptive rights or similar rights to subscribe for or purchase securities.  Except (i) as set forth in the SEC Documents, (ii) for options issued to officers, directors and employees of the Company under its employee benefit plans and (iii) for warrants issued to Leaders Bank entitling Leaders Bank to purchase a number of shares of Common Stock not to exceed 100,000 shares and (iv) as provided in the SEDA, there are no outstanding rights (including, without limitation, preemptive rights), warrants or options to acquire, or instruments convertible into or exchangeable for, any unissued shares of capital stock or other equity interest in the Company, or any contract, commitment, agreement, understanding or arrangement of any kind to which the Company is a party or of which the Company has knowledge and relating to the issuance or sale of any capital stock of the Company, any such convertible or exchangeable securities or any such rights, warrants or options.  Without limiting the foregoing, no preemptive right, co-sale right, right of first refusal or other similar right exists with respect to the Shares or the issuance and sale thereof.  No further approval or authorization of any stockholder or the Board of Directors of the Company or others is required for the issuance and sale of the Shares.  Except as disclosed in the SEC Documents, there are no stockholders agreements, voting agreements or other similar agreements with respect to the capital stock of the Company to which the Company is a party or, to the knowledge of the Company, between or among any of the Company’s stockholders. The issuance and sale of the Shares will not result in a right of any current holder of Company securities to adjust the exercise, conversion, exchange or reset price under any securities of the Company.

 

2.5             Legal Proceedings; Disagreements with Advisors.  There is no material legal or governmental investigation, action, suit or proceeding pending or, to the knowledge of the Company, threatened to which the Company is or may be a party or of which the business or property of the Company is or could reasonably be expected to be subject that is not disclosed in the SEC Documents.  There are no material disagreements presently existing, or reasonably anticipated by the Company to arise, between the accountants formerly or presently employed by the Company.

 

2.6             No Violations.  The Company is not (i) in violation of its charter, bylaws or any other organizational documents; (ii) in violation of any federal, state or local law, administrative regulation,

 

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ordinance or order of any court or governmental agency, arbitration panel or authority applicable to the Company, which violation, individually or in the aggregate, would be reasonably likely to have a Material Adverse Effect; or (iii) in default (and there exists no condition which, with the passage of time or otherwise, would constitute a default) in the performance of any bond, debenture, note or any other evidence of indebtedness, any indenture, mortgage or deed of trust or any other agreement or instrument to which the Company is a party or by which the Company is bound or by which the properties of the Company are bound, which would be reasonably likely to have a Material Adverse Effect.

 

2.7             Governmental Permits, Etc.  With the exception of the matters which are dealt with separately in Sections 2.1 and 2.11, the Company has all necessary permits, franchises, licenses, certificates and other authorizations from any foreign, federal, state or local government or governmental agency, department, or body that are currently necessary for the operation of the business of the Company as currently conducted and as described in the SEC Documents, except where the failure to currently possess any such permit, franchise, license, certificate or other authorization would not be reasonably expected to have a Material Adverse Effect.

 

2.8             Intellectual Property.  Except as specifically disclosed in the SEC Documents (i)  the Company owns or possesses sufficient rights to use all patents, patent rights, trademarks, copyrights, licenses, inventions, trade secrets, trade names and know-how (including trade secrets and other unpatented and/or unpatentable property or confidential information, systems, processes, methods or procedures) (collectively, “Intellectual Property”) that are necessary for the conduct of its business as now conducted or as described in the SEC Documents except where the failure to currently own or possess would not reasonably be expected to have a Material Adverse Effect, (ii) the Company is not infringing, and has not received any notice of, and has no knowledge of, any asserted infringement by the Company of, any rights of a third party with respect to any Intellectual Property that, individually or in the aggregate, would reasonably be expected to have a Material Adverse Effect and (iii) the Company has not received any notice of, and has no knowledge of, infringement by a third party with respect to any Intellectual Property rights of the Company that, individually or in the aggregate, would reasonably be expected to have a Material Adverse Effect.  Further, except as described in the SEC Documents or exhibits thereto, or as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, no third party, including any academic or governmental organization, possesses rights to any Intellectual Property which, if exercised, could enable such third party to develop products competitive with the business of the Company as currently being conducted.

 

2.9             Financial Statements; Obligations to Related Parties.  (a) The financial statements of the Company and the related notes contained in the SEC Documents present fairly, in accordance with generally accepted accounting principles (“GAAP”), the financial position of the Company as of the dates indicated therein, and the results of its operations and cash flows for the periods specified therein consistent with the books and records of the Company except that the unaudited interim financial statements were or are subject to normal and recurring year-end adjustments which are not expected to be material in amount.  Such financial statements (including the related notes) have been prepared in accordance with GAAP applied on a consistent basis throughout the periods therein specified, except as may be disclosed in the notes to such financial statements, or in the case of unaudited statements, as may be permitted by the Securities and Exchange Commission (the “SEC”) on Form 10-Q under the Exchange Act and except as disclosed in the SEC Documents.  The other financial information contained in the SEC Documents has been prepared on a basis consistent with the financial statements of the Company.  As of their respective dates, the financial statements of the Company included in the SEC Documents complied as to form in all material respects with applicable accounting requirements and published rules and regulations of the SEC with respect thereto.

 

(b)           Except as set forth in any SEC Documents, there are no obligations of the Company to officers, directors, stockholders or employees of the Company other than (i) for payment of salary for

 

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services rendered and for bonus payments made in the ordinary course of business consistent with past practice; (ii) reimbursements for reasonable expenses incurred on behalf of the Company; (iii) for other standard employee benefits made generally available to all employees (including stock option agreements outstanding under any stock option plan approved by the Board of Directors and stockholders of the Company); and (iv) obligations listed in the Company’s financial statements contained in the SEC Documents.

 

2.10           No Material Adverse Change.  Since June 30, 2008, there has not been (i) any material adverse change in the financial condition or earnings of the Company, (ii) any material adverse event affecting the Company, (iii) any obligation, direct or contingent, that is material to the Company, incurred by the Company, except for (A) an increase to the Company’s loan facility with Leaders Bank in the amount of $5 million, effective on or about the date hereof, (B) the Company’s obligations pursuant to that certain Fifth Amendment to License Agreement with Abbott Laboratories, effective on or about the date hereof and (C) obligations incurred in the ordinary course of business consistent with past practice, (iv) any dividend or distribution of any kind declared, paid or made on the capital stock of the Company or (v) any loss or damage (whether or not insured) to the physical property of the Company which has been sustained, which, individually or in the aggregate, would reasonably be expected to have a Material Adverse Effect.

 

2.11           Nasdaq Compliance.  The Company’s Common Stock is registered pursuant to Section 12(g) of the Exchange Act and is listed on Nasdaq, and the Company has taken no action designed to, or that would reasonably be expected to, have the effect of, terminating the registration of the Common Stock under the Exchange Act or de-listing the Common Stock from Nasdaq, nor has the Company received any notification that the SEC or Nasdaq is contemplating terminating such registration or listing.

 

2.12           Reporting Status.  The Company has filed in a timely manner all documents that the Company was required to file under the Exchange Act and the Securities Act during the preceding twelve months.  All such documents complied in all material respects with the SEC’s requirements as of their respective filing dates, and the information contained therein as of the date thereof did not contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein in light of the circumstances under which they were made not misleading.

 

2.13           Company not an “Investment Company”.  The Company has been advised of the rules and requirements under the Investment Company Act of 1940, as amended (the “Investment Company Act”).  The Company is not, and immediately after the purchase and sale of the Shares will not be, an “investment company” or, to the knowledge of the Company, an entity “controlled” by an “investment company” within the meaning of the Investment Company Act and shall conduct its business in a manner so that it will not become subject to the Investment Company Act.

 

2.14           Foreign Corrupt Practices.  Neither the Company, nor to the knowledge of the Company, any agent or other person acting on behalf of the Company, has (i) directly or indirectly, used any corporate funds for unlawful contributions, gifts, entertainment or other unlawful expenses related to foreign or domestic political activity, (ii) made any unlawful payment to foreign or domestic government officials or employees or to any foreign or domestic political parties or campaigns from corporate funds, (iii) failed to disclose fully any contribution made by the Company (or made by any person acting on its behalf of which the Company is aware) which is in violation of law; (iv) violated in any material respect any provision of the Foreign Corrupt Practices Act of 1977, as amended; or (v) made any unlawful bribe, rebate, payoff, influence payment, kickback or other unlawful payment to any foreign or domestic government official or employee.

 

2.15         Accountants.  Deloitte & Touche LLP, who have audited certain financial statements included in the SEC Documents, is an independent registered public accounting firm as required

 

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by the Securities Act, the rules and regulations promulgated thereunder and the Public Company Accounting Oversight Board.  Except as pre-approved in accordance with the requirements set forth in Section 10A of the Exchange Act, Deloitte & Touche LLP has not been engaged by the Company to perform any “prohibited activities” (as defined in Section 10A of the Exchange Act).

 

2.16           Contracts.  The contracts described in and/or filed as exhibits to the SEC Documents that are material to the Company are in full force and effect, and neither the Company nor, to the Company’s knowledge, any other party to such contracts is in breach of or default, or received a notice of termination, under any of such contracts which would reasonably be expected to have a Material Adverse Effect.  The Company has filed with the SEC all contracts and agreements required to be filed by the Exchange Act and the Securities Act.

 

2.17           Taxes.  The Company has filed (or has obtained from the applicable tax authority an extension of time within which to file) all necessary federal, state and foreign income and franchise tax returns and has paid all taxes shown as due on such tax returns, except where the failure to so file or the failure to so pay would not reasonably be expected to have a Material Adverse Effect.  The Company is not aware of any tax deficiency that has been or might be asserted or threatened against it that would reasonably be expected to have a Material Adverse Effect.

 

2.18           Private Offering.  The offer and sale of the Shares are exempt from registration under the Securities Act.  The Company has not in the past nor will it hereafter take any action to sell, offer for sale or solicit offers to buy any securities of the Company which would bring the offer, issuance or sale of the Shares as contemplated by this Agreement within the provisions of Section 5 of the Securities Act, unless such offer, issuance or sale was or shall be within the exemptions of Section 4 of the Securities Act.

 

2.19           Disclosure Controls and Procedures.  The Company is in material compliance with all provisions of the Sarbanes-Oxley Act of 2002 which are applicable to it as of the Closing Date.  The Company maintains a system of internal control over financial reporting (as such term is defined in the Exchange Act) sufficient to provide reasonable assurance that (i) transactions are executed in accordance with management’s general or specific authorizations, (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with GAAP and to maintain asset accountability, (iii) access to assets is permitted only in accordance with management’s general or specific authorization and (iv) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences.  The Company’s certifying officers are responsible for establishing and maintaining disclosure controls and procedures (as defined in the Exchange Act) for the Company and they have (a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under their supervision, to ensure that material information relating to the Company is made known to the certifying officers by others within the Company, particularly during the periods in which the Company’s filings under the Exchange Act have been prepared; and (b) evaluated the effectiveness of the Company’s disclosure controls and procedures and presented in the Company’s filings under the Exchange Act their conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the periods covered by such filings under the Exchange Act based on such evaluation.  In addition, since the last evaluation date referred to in (b) above, there has been no change in the Company’s internal control over financial reporting that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting (as such term is defined in the Exchange Act) or, to the Company’s knowledge, in other factors that could significantly affect the Company’s internal control over financial reporting.

 

2.20           Transactions With Affiliates.  There are no business relationships or related-party transactions involving the Company or any other person required to be described in the SEC Documents that have not been described as required.

 

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2.21           Company Acknowledgement of Investor Representation.  The Company acknowledges and agrees that the Investor does not make or has not made any representations or warranties with respect to the purchase and sale of the Shares other than those specifically set forth in Article III.

 

2.22           Regulatory Matters.  The Company does not have knowledge of any actual or threatened enforcement action by the United States Food and Drug Administration (“FDA”) or any other governmental authority which has jurisdiction over the operations of the Company, and has not received notice of any pending or threatened claim by the FDA or any other governmental authority which has jurisdiction over the operations of the Company, against the Company or any of its subsidiaries, and the Company has no knowledge or reason to believe that any governmental authority is considering such action.  All permits, licenses and other material reports, documents, claims and notices required to be filed, maintained or furnished to the FDA or any governmental authority by the Company have been so filed, maintained or furnished and were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing) such that no liability exists with respect to the completeness or accuracy of any such filing.  All studies, tests and preclinical and clinical trials conducted by, or on behalf of, the Company have been conducted in material compliance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and applicable local, state and federal laws, rules, regulations and guidances, including, but not limited to the applicable requirements of Good Laboratory Practices or Good Clinical Practices, as applicable.  To the knowledge of the Company, there are no studies, tests or trials the results of which call into question the clinical results described or referred to in the SEC Documents.  The Company has not received any notices, correspondence or other communication from the FDA or any other governmental authority requiring the termination, suspension or material modification of any ongoing or planned clinical trials conducted by, or on behalf of, the Company, or in which the Company has participated, and the Company has no knowledge or reason to believe that the FDA or any other governmental authority is considering such action.  Neither the Company nor, to the knowledge of the Company, any officer, employee or agent of the Company has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in debarment under 21 U.S.C. Section 335a or any similar law or regulation.

 

2.23           Insurance.  The Company is insured by insurers of recognized financial responsibility against such losses and risks and in such amounts as prudent and customary for similarly situated companies in the businesses in which the Company and its subsidiaries are engaged.  The Company has no reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage expires or to obtain similar coverage from similar insurers as may be necessary to continue its business at a cost that would not have a Material Adverse Effect.

 

2.24           Off-Balance Sheet Arrangements.  There is no transaction, arrangement or other relationship between the Company, on the one hand, and an unconsolidated or other off-balance sheet entity, on the other hand, that may create contingencies or liabilities for the Company.

 

2.25           No Manipulation of Stock.  The Company has not taken and will not, in violation of applicable law, take any action designed to or that might reasonably be expected to cause or result in stabilization or manipulation of the price of the Common Stock to facilitate the sale or resale of any of the Shares.

 

2.26           Disclosure.  The representations and warranties of the Company contained in this Article II, as of the date hereof and as of the Closing Date, do not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading.

 

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ARTICLE III

REPRESENTATIONS, WARRANTIES AND COVENANTS OF THE INVESTOR

 

3.1             The Investor represents and warrants to, and covenants with, the Company that: (i) the Investor is an “accredited investor” as defined in Regulation D under the Securities Act and the Investor is also knowledgeable, sophisticated and experienced in making decisions with respect to investments in securities presenting an investment decision like that involved in the purchase of the Shares, and has requested, received, reviewed and considered all information it deemed relevant in making an informed decision to purchase the Shares; (ii) the Investor is acquiring the Shares in the ordinary course of its business and for its own account for investment only and with no present intention of distributing any of the Shares or any arrangement or understanding with any other persons regarding the distribution of the Shares; and (iii) the Investor will not, directly or indirectly, offer, sell, pledge, transfer or otherwise dispose of (or solicit any offers to buy, purchase or otherwise acquire or take a pledge of) any of the Shares except in compliance with the Securities Act, applicable state securities laws and the respective rules and regulations promulgated thereunder.

 

3.2             The Investor understands that the Shares that it is acquiring are characterized as “restricted securities” under the federal securities laws inasmuch as they are being acquired in a transaction not involving a public offering, and that under such laws and applicable regulations such Shares may be resold without registration under the Securities Act only in certain limited circumstances. In this connection, the Investor represents that it is familiar with SEC Rule 144, as presently in effect, and understands the resale limitations imposed thereby and by the Securities Act.  The Investor hereby covenants with the Company not to make any sale of the Shares without complying with the provisions of this Agreement.

 

3.3             The Investor further represents and warrants to, and covenants with, the Company that (i) the Investor has the requisite corporate power and authority to execute, deliver and perform its obligations under this Agreement and has taken all necessary corporate action to authorize the execution, delivery and performance of this Agreement, and (ii) this Agreement constitutes a valid and binding obligation of the Investor enforceable against the Investor in accordance with its terms, except as enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ and contracting parties’ rights generally, except as enforceability may be subject to general principles of equity (regardless of whether such enforceability is considered in a proceeding in equity or at law) and except as the indemnification agreements of the Investor herein may be legally unenforceable.

 

3.4             The Investor understands that nothing in the SEC Documents, this Agreement or any other materials presented to the Investor in connection with the purchase and sale of the Shares constitutes legal, tax or investment advice.  The Investor has consulted such legal, tax and investment advisors as it, in its sole discretion, has deemed necessary or appropriate in connection with its purchase of the Shares.

 

ARTICLE IV

SURVIVAL OF REPRESENTATIONS, WARRANTIES AND AGREEMENTS

 

4.1             Notwithstanding any investigation made by any party to this Agreement, all covenants, agreements, representations and warranties made by the Company and the Investor herein shall survive the execution of this Agreement and the delivery to the Investor of the Shares being purchased; provided that the representations and warranties contained herein shall expire on the one-year anniversary of the Closing Date.

 

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ARTICLE V

LEGEND; RESTRICTIONS ON TRANSFER

 

5.1           The certificates for the Shares (and any securities issued in respect of or exchange for the Shares) shall be subject to a legend or legends restricting transfer under the Securities Act and referring to restrictions on transfer herein, such legend to be substantially as follows:

 

THE SECURITIES REPRESENTED BY THIS CERTIFICATE (THE “SECURITIES”) HAVE BEEN ISSUED AND SOLD IN RELIANCE UPON EXEMPTIONS FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “1933 ACT”), AND APPROPRIATE EXEMPTIONS FROM REGISTRATION UNDER THE SECURITIES LAWS OF OTHER APPLICABLE JURISDICTIONS. THE SECURITIES MAY NOT BE OFFERED FOR SALE, SOLD OR TRANSFERRED OTHER THAN PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT OR AN EXEMPTION FROM THE REGISTRATION REQUIREMENTS UNDER THE 1933 ACT AND THE APPLICABLE SECURITIES LAWS OF ANY OTHER JURISDICTION.  THE ISSUER SHALL BE ENTITLED TO REQUIRE AN OPINION OF COUNSEL REASONABLY SATISFACTORY TO IT WITH RESPECT TO COMPLIANCE OF THE PROPOSED SALE OR TRANSFER WITH THE REGISTRATION REQUIREMENTS OF THE 1933 ACT OR EXEMPTION THEREFROM.

 

ARTICLE VI

REGISTRATION OF THE SHARES; COMPLIANCE WITH THE SECURITIES ACT

 

6.1           Piggyback Registration Rights.  The Company shall notify the Investor in writing at least twenty (20) days prior to the filing of any registration statement under the Securities Act for purposes of a public offering of securities of the Company (including, but not limited to, registration statements relating to secondary offerings of securities of the Company, but excluding registration statements relating to employee benefit plans or with respect to corporate reorganizations or other transactions under Rule 145 of the Securities Act) (each, a “Registration Statement”) and will afford the Investor or its permitted assignees an opportunity to include in such Registration Statement all or part of the Shares (“Registrable Securities”) held by such holder (each, a “Holder”).  Each Holder desiring to include in any such Registration Statement all or any part of the Registrable Securities held by it shall, within twenty (20) days after the above-described notice from the Company, so notify the Company in writing.  Such notice shall state the intended method of disposition of the Registrable Securities by such Holder.  The Company shall use its best efforts to cause all Registrable Securities which the Company has been requested by Holders to register to be registered under the Securities Act to the extent necessary to permit their sale in accordance with the intended method of distribution.  If a Holder decides not to include all of its Registrable Securities in any Registration Statement thereafter filed by the Company, such Holder shall nevertheless continue to have the right to include any Registrable Securities in any subsequent Registration Statement or Registration Statements as may be filed by the Company with respect to offerings of its securities, all upon the terms and conditions set forth herein.

 

If a Registration Statement under which the Company gives notice under this Section 6.1 is for an underwritten offering, the Company shall so advise the Holders.  In such event, the right of any such Holder to be included in a registration pursuant to this Section 6.1 shall be conditioned upon such Holder’s participation in such underwriting and the inclusion of such Holder’s Registrable Securities in the underwriting to the extent provided herein.  All Holders proposing to distribute their Registrable Securities through such underwriting shall enter into an underwriting agreement in customary form with the underwriter or underwriters selected for such underwriting by the Company.

 

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Notwithstanding any other provision of the Agreement, in connection with a registration statement that involves the primary offer and sale of securities by the Company for cash, if the underwriter determines in good faith that marketing factors require a limitation of the number of shares to be underwritten, the number of shares that may be included in the underwriting shall be allocated, first, to the Company and second, to all selling securityholders proposing to participate in the offering through the exercise of registration rights (the “Participating Sellers”) on a pro rata basis based on the total number of shares subject to registration rights held by such Participating Sellers.  No such reduction shall reduce the securities being offered by the Company for its own account to be included in the registration and underwriting.  In no event will shares of any other selling stockholder be included in such registration that would reduce the number of shares that may be included by the Participating Sellers without the written consent of Participating Sellers holding not less than a majority of the shares subject to registration rights proposed to be sold in the offering.

 

6.2           Registration Procedures and Other Matters.  In connection with any Registration Statement under which Registrable Securities are included pursuant to Section 6.1, the Company shall:

 

                (a)           use its best efforts to prepare and file with the SEC such amendments and supplements to the Registration Statement in compliance with applicable laws, and the prospectus used in connection therewith (the “Prospectus”), as may be necessary to keep the Registration Statement current, effective and free from any material misstatement or omission to state a material fact for a period not exceeding (i) the second anniversary of the date of filing of the Registration Statement, or (ii) such time as all of the Registrable Securities have been sold;

 

                (b)           furnish to each Holder participating in such registration (each, a “Participating Holder”) such number of copies of the Registration Statement, Prospectus and preliminary Prospectus in conformity with the requirements of the Securities Act and such other documents as the Holder may reasonably request, in order to facilitate the public sale or other disposition of all or any of the Registrable Securities by the Holder;

 

                (c)           file documents required of the Company for blue sky clearance in states specified in writing by the Participating Holders and use its commercially reasonable efforts to maintain such blue sky qualifications during the period the Company is required to maintain the effectiveness of the Registration Statement pursuant to Section 6.2(a); provided, however, that the Company shall not be required to qualify to do business or consent to service of process in any jurisdiction in which it is not now so qualified or has not so consented;

 

                (d)           bear all expenses in connection with this Section 6.2 and the registration of the Registrable Securities pursuant to the Registration Statement (other than underwriting discounts or commissions, brokers’ fees and similar selling expenses and any other fees or expenses incurred by a Holder, including attorneys’ fees);

 

                (e)           advise the Participating Holders, promptly after the Company shall receive notice or obtain knowledge of the issuance of any stop order by the SEC delaying or suspending the effectiveness of the Registration Statement or of the initiation or threat of any proceeding for that purpose; and the Company shall promptly use its commercially reasonable efforts to prevent the issuance of any stop order or to obtain its withdrawal as promptly as possible if such stop order should be issued; and

 

                (f)            within one (1) business day following the effectiveness date of the Registration Statement, give notice to the Participating Holders of such effectiveness and, within two (2) business days following such effectiveness, use its commercially reasonable efforts to cause its counsel to issue an appropriate opinion or opinions to the transfer agent substantially to the effect that the Registrable

 

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Securities included under the Registration Statement are subject to an effective registration statement and can be reissued free of restrictive legend in accordance with provisions of Section 6.7.

 

6.3           Transfer of the Shares after Registration; Suspension.

 

                (a)           Except in the event that paragraph (b) below applies, the Company shall (i) if deemed necessary by the Company, prepare and file from time to time with the SEC a post-effective amendment to the applicable Registration Statement or a supplement to the related Prospectus or a supplement or amendment to any document incorporated therein by reference or file any other required document so that such Registration Statement will not contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading, and so that, as thereafter delivered to purchasers of the Registrable Securities being sold thereunder, such Prospectus will not contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading; (ii) provide each Participating Holder with copies of any documents filed pursuant to Section 6.3(a)(i) as it reasonably requests; and (iii) inform each Participating Holder that the Company has complied with its obligations in Section 6.3(a)(i) (or that, if the Company has filed a post-effective amendment to the Registration Statement which has not yet been declared effective, the Company shall notify each Participating Holder to that effect, use its best efforts to secure the effectiveness of such post-effective amendment as promptly as reasonably possible and promptly notify each Participating Holder when the amendment has become effective).

 

                (b)           Subject to paragraph (c) below, in the event (i) of any request by the SEC or any other federal or state governmental authority during the period of effectiveness of the applicable Registration Statement for amendments or supplements to such Registration Statement or related Prospectus or for additional information, (ii) of the issuance by the SEC or any other federal or state governmental authority of any stop order suspending the effectiveness of a Registration Statement or the initiation of any proceedings for that purpose, (iii) of the receipt by the Company of any notification with respect to the suspension of the qualification or exemption from qualification of any of the Registrable Securities for sale in any jurisdiction or the initiation or threatening of any proceeding for such purpose or (iv) of any event or circumstance which, upon the good faith judgment of the Company’s Board of Directors based on the advice of its counsel, necessitates the making of any changes in a Registration Statement or Prospectus, or any document incorporated or deemed to be incorporated therein by reference, so that, in the case of such Registration Statement, it will not contain any untrue statement of a material fact or any omission to state a material fact required to be stated therein or necessary to make the statements therein not misleading, and that in the case of the Prospectus, it will not contain any untrue statement of a material fact or any omission to state a material fact required to be stated therein or necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading, the Company shall deliver a certificate in writing to each Participating Holder (the “Suspension Notice”) to the effect of the foregoing and, upon receipt of such Suspension Notice, each Participating Holder shall refrain from selling any of the Registrable Securities pursuant to the Registration Statement (a “Suspension”) until a supplemented or amended Prospectus is prepared and filed by the Company, or until it is advised in writing by the Company that the current Prospectus may be used.  In the event of any Suspension, the Company shall use its best efforts to cause the use of the Prospectus so suspended to be resumed as soon as reasonably practicable after the delivery of a Suspension Notice to each Participating Holder.

 

                (c)           Notwithstanding the foregoing paragraphs of this Section 6.3, a Participating Holder shall not be prohibited from selling any of the Registrable Securities under the applicable Registration Statement as a result of Suspensions on more than two (2) occasions of not more than thirty (30) days each in any twelve (12) month period, unless, in the good faith judgment of the Company’s Board of Directors based on the advice of its counsel, the sale of the Registrable Securities

 

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under such Registration Statement in reliance on this Section 6.3(c) would be reasonably likely to cause a violation of the Securities Act or the Exchange Act and result in liability to the Company.

 

                (d)           Provided that a Suspension is not then in effect, a Participating Holder may sell any of the Registrable Securities under the applicable Registration Statement.  Upon receipt of a request therefor, the Company has agreed to provide an adequate number of current Prospectuses to the Participating Holders and to supply copies to any other parties requiring such Prospectuses pursuant to the Securities Act.

 

6.4           Indemnification.

 

                (a)           For the purpose of this Section 6.4:

 

                                (i)            the term “Selling Stockholder” means the Investor and any affiliate of the Investor;

 

                                (ii)           the term “Registration Statement” shall include the Prospectus in the form first filed with the SEC pursuant to Rule 424(b) of the Securities Act or filed as part of the applicable Registration Statement at the time of effectiveness if no Rule 424(b) filing is required, and any exhibit, supplement or amendment included in or relating to such Registration Statement referred to in Section 6.1; and

 

                                (iii)          the term “untrue statement” for purposes of Section 6.4(e) hereof shall include any untrue statement or alleged untrue statement, or any omission or alleged omission to state in the Registration Statement a material fact required to be stated therein or necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading.

 

                (b)           The Company agrees to indemnify and hold harmless each Selling Stockholder from and against any losses, claims, damages or liabilities to which such Selling Stockholder may become subject (under the Securities Act or otherwise) insofar as such losses, claims, damages or liabilities (or actions or proceedings in respect thereof) arise out of or are based upon (i) any breach of any of the representations or warranties of the Company contained herein or failure to comply with any of the covenants and agreements of the Company contained herein, (ii) any untrue statement of a material fact contained in the applicable Registration Statement as amended at the time of effectiveness or any omission of a material fact required to be stated therein or necessary to make the statements therein not misleading, or (iii) any failure by the Company to fulfill any undertaking included in such Registration Statement as amended at the time of effectiveness, and the Company will reimburse such Selling Stockholder for any reasonable legal or other expenses reasonably incurred in investigating, defending or preparing to defend any such action, proceeding or claim, or preparing to defend any such action, proceeding or claim; provided, however, that the Company shall not be liable to a Selling Stockholder to the extent that such loss, claim, damage or liability arises out of, or is based upon, an untrue statement made in such Registration Statement or any omission of a material fact required to be stated therein or necessary to make the statements therein not misleading in reliance upon and in conformity with written information furnished to the Company by or on behalf of such Selling Stockholder specifically for use in preparation of such Registration Statement, or the failure of such Selling Stockholder to comply with its covenants and agreements contained in Section 6.3 hereof respecting sale of the Registrable Securities or any statement or omission in any Prospectus that is corrected in any subsequent Prospectus that was delivered to the Selling Stockholder prior to the pertinent sale or sales by the Selling Stockholder.  The Company shall reimburse each Selling Stockholder for the amounts provided for herein on demand as such expenses are incurred as reasonably documented by the Selling Stockholder.

 

                (c)           The Investor agrees to indemnify and hold harmless the Company (and each person, if any, who controls the Company within the meaning of Section 15 of the Securities Act, each

 

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officer of the Company who signs the applicable Registration Statement and each director of the Company) from and against any losses, claims, damages or liabilities to which the Company (or any such officer, director or controlling person) may become subject (under the Securities Act or otherwise), insofar as such losses, claims, damages or liabilities (or actions or proceedings in respect thereof) arise out of, or are based upon, (i) any failure by the Investor to comply with the covenants and agreements contained in Section 6.3 hereof respecting sale of the Registrable Securities or (ii) any untrue statement of a material fact contained in such Registration Statement or any omission of a material fact required to be stated therein or necessary to make the statements therein not misleading if such untrue statement or omission was made in reliance upon and in conformity with written information furnished by or on behalf of the Investor specifically for use in preparation of such Registration Statement, and the Investor will reimburse the Company (or such officer, director or controlling person, as the case may be) for any legal or other expenses reasonably incurred in investigating, defending or preparing to defend any such action, proceeding or claim; provided, however, that the Investor’s obligation to indemnify the Company shall be limited to the net amount received by the Investor from the sale of Registrable Securities by the Investor pursuant to such Registration Statement.

 

                (d)           Promptly after receipt by any indemnified person of a notice of a claim or the beginning of any action in respect of which indemnity is to be sought against an indemnifying person pursuant to this Section 6.4, such indemnified person shall notify the indemnifying person in writing of such claim or of the commencement of such action, but the omission to so notify the indemnifying person will not relieve it from any liability which it may have to any indemnified person under this Section 6.4 (except to the extent that such omission materially and adversely affects the indemnifying person’s ability to defend such action) or from any liability otherwise than under this Section 6.4.  Subject to the provisions hereinafter stated, in case any such action shall be brought against an indemnified person, the indemnifying person shall be entitled to participate therein, and, to the extent that it shall elect by written notice delivered to the indemnified person promptly after receiving the aforesaid notice from such indemnified person, shall be entitled to assume the defense thereof, with counsel reasonably satisfactory to such indemnified person.  After notice from the indemnifying person to such indemnified person of its election to assume the defense thereof, such indemnifying person shall not be liable to such indemnified person for any legal expenses subsequently incurred by such indemnified person in connection with the defense thereof; provided, however, that if there exists or shall exist a conflict of interest that would make it inappropriate, in the opinion of counsel to the indemnified person, for the same counsel to represent both the indemnified person and such indemnifying person or any affiliate or associate thereof, the indemnified person shall be entitled to retain its own counsel at the expense of such indemnifying person; provided, however, that no indemnifying person shall be responsible for the fees and expenses of more than one separate counsel (together with appropriate local counsel) for all indemnified parties hereunder.  In no event shall any indemnifying person be liable in respect of any amounts paid in settlement of any action unless the indemnifying person shall have approved the terms of such settlement; provided that such consent shall not be unreasonably withheld.  No indemnifying person shall, without the prior written consent of the indemnified person, effect any settlement of any pending or threatened proceeding in respect of which any indemnified person is or could have been a party and indemnification could have been sought hereunder by such indemnified person, unless such settlement includes an unconditional release of such indemnified person from all liability on claims that are the subject matter of such proceeding.

 

                (e)           If the indemnification provided for in this Section 6.4 is unavailable to or insufficient to hold harmless an indemnified person under subsection (b) or (c) above in respect of any losses, claims, damages or liabilities (or actions or proceedings in respect thereof) referred to therein, then each indemnifying person shall contribute to the amount paid or payable by such indemnified person as a result of such losses, claims, damages or liabilities (or actions in respect thereof) in such proportion as is appropriate to reflect the relative fault of the Company on the one hand and the Investor, as well as any other Selling Stockholders under the applicable Registration Statement, on the other in connection with the statements or omissions or other matters which resulted in such losses, claims, damages or liabilities (or

 

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actions in respect thereof), as well as any other relevant equitable considerations.  The relative fault shall be determined by reference to, among other things, in the case of an untrue statement, whether the untrue statement relates to information supplied by the Company on the one hand or the Investor or other Selling Stockholder on the other and the parties’ relative intent, knowledge, access to information and opportunity to correct or prevent such untrue statement.  The Company and the Investor agree that it would not be just and equitable if contribution pursuant to this subsection (e) were determined by pro rata allocation (even if the Investor and other Selling Stockholders were treated as one entity for such purpose) or by any other method of allocation which does not take into account the equitable considerations referred to above in this subsection (e).  The amount paid or payable by an indemnified person as a result of the losses, claims, damages or liabilities (or actions in respect thereof) referred to above in this subsection (e) shall be deemed to include any legal or other expenses reasonably incurred by such indemnified person in connection with investigating or defending any such action or claim.  Notwithstanding the provisions of this subsection (e), the Investor shall not be required to contribute any amount in excess of the amount by which the net amount received by the Investor from the sale of Registrable Securities to which such loss relates exceeds the amount of any damages which the Investor has otherwise been required to pay by reason of such untrue statement.  No person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) shall be entitled to contribution from any person who was not guilty of such fraudulent misrepresentation.  The Investor’s obligations in this subsection (e) to contribute shall be in proportion to its sale of the Registrable Securities to which such loss relates and shall not be joint with any other Selling Stockholders.

 

                (f)            The parties to the Agreement hereby acknowledge that they are sophisticated business persons who were represented by counsel during the negotiations regarding the provisions hereof including, without limitation, the provisions of this Section 6.4, and are fully informed regarding said provisions.  They further acknowledge that the provisions of this Section 6.4 fairly allocate the risks in light of the ability of the parties to investigate the Company and its business in order to assure that adequate disclosure is made in the applicable Registration Statement as required by the Securities Act and the Exchange Act.  The parties are advised that federal or state public policy as interpreted by the courts in certain jurisdictions may be contrary to certain of the provisions of this Section 6.4, and the parties hereto hereby expressly waive and relinquish any right or ability to assert such public policy as a defense to a claim under this Section 6.4 and further agree not to attempt to assert any such defense.

 

6.5           Termination of Conditions and Obligations.  The conditions precedent imposed by Section 3 or this Section 6 upon the transferability of the Shares shall cease and terminate as to any particular number of the Shares when such Shares shall have been effectively registered under the Securities Act and sold or otherwise disposed of in accordance with a Registration Statement covering such Shares or at such time as an opinion of counsel reasonably satisfactory to the Company shall have been rendered to the effect that such conditions are not necessary in order to comply with the Securities Act.

 

6.6           Information Available.  So long as the applicable Registration Statement is effective covering the resale of any of the Shares owned by the Investor, the Company shall furnish to the Investor:

 

                (a)           as soon as practicable after it is available, one copy of (i) its Annual Report to Stockholders (which Annual Report shall contain financial statements audited in accordance with GAAP by a national firm of certified public accountants), (ii) its Annual Report on Form 10-K and (iii) its Quarterly Reports on Form 10-Q (the foregoing, in each case, excluding exhibits);

 

                (b)           upon the reasonable request of the Investor, all exhibits excluded by the parenthetical to subsection (a) of this Section 6.6 as filed with the SEC and all other information that is made available to stockholders; and

 

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                (c)           upon the reasonable request of the Investor, an adequate number of copies of the Prospectuses to supply to any other party requiring such Prospectuses.

 

6.7           Restrictions on Transfer.  The Investor expressly agrees that any sale by such Investor of any Shares pursuant to the applicable Registration Statement shall be sold in a manner described under the caption “Plan of Distribution” in such Registration Statement.  The Investor further agrees that such Shares shall only be sold while such Registration Statement is effective, unless exemption from registration is available.  On the basis of compliance by the Investor with the foregoing covenants, upon effectiveness of such Registration Statement, the Company shall as soon as practicable (but not later than three (3) business days after surrender of the legended certificates to the Company) cause certificates evidencing such Shares previously issued to be replaced with certificates which do not bear the restrictive legends specified above in Section 5.1.  The Investor acknowledges that the removal of the restrictive legends from certificates representing such Shares as provided in this Section 6.7 is predicated upon the Company’s reliance on the Investor’s compliance with its covenants in this Section 6.7.  In addition, upon request by the Investor at least six (6) months after the Closing Date, the Company shall as soon as practicable (but not later than three (3) business days after surrender of the legended certificates to the Company) cause certificates evidencing any Shares previously issued to be replaced with certificates which do not bear the restrictive legends specified above in Section 5.1, subject to compliance with Rule 144 under the Securities Act.

 

ARTICLE VII

MISCELLANEOUS

 

7.1           Notices.  All notices, requests, consents and other communications hereunder shall be in writing and shall be delivered and addressed as set forth in the License Agreement.

 

7.2           Changes.  This Agreement may be modified, amended or waived only pursuant to a written instrument signed by the Company and the Investor.

 

7.3           Headings.  The headings of the various sections of this Agreement have been inserted for convenience of reference only and shall not be deemed to be part of this Agreement.

 

7.4           Severability.  In case any provision contained in this Agreement should be held by a court of competent jurisdiction to be invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby.

 

7.5           Governing Law.  This Agreement shall be governed by, and construed in accordance with, the laws of the State of New York, without giving effect to the principles of conflicts of law.

 

7.6           Counterparts.  This Agreement may be executed in two or more counterparts, each of which shall constitute an original, but all of which, when taken together, shall constitute but one instrument, and shall become effective when one or more counterparts have been signed by each party hereto and delivered to the other party.

 

7.7           Entire Agreement.  This Agreement constitutes the entire agreement between the parties hereto with respect to the purchase and sale of the Shares, and supersedes any prior understandings or agreements concerning the purchase and sale of the Shares.

 

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7.8           Rule 144.  For three years from the Closing Date, the Company covenants that it will timely file the reports required to be filed by it under the Securities Act and the Exchange Act and the rules and regulations adopted by the SEC thereunder (or, if the Company is not required to file such reports, it will, upon the request of the Investor for so long as the Investor holds any of the Shares purchased hereunder, make publicly available such information as necessary to permit sales pursuant to Rule 144 under the Securities Act), and it will take such further action as the Investor may reasonably request, all to the extent required from time to time to enable the Investor to sell such Shares without registration under the Securities Act within the limitation of the exemptions provided by (a) Rule 144 under the Securities Act, as such Rule may be amended from time to time, or (b) any similar rule or regulation hereafter adopted by the SEC.  Upon the request of the Investor, the Company will deliver a written statement as to whether it has complied with such information and requirements.

 

7.9           No Third-Party Beneficiaries.  Except as may otherwise be expressly set forth herein, this Agreement is intended for the benefit of the parties hereto and their respective successors and permitted assigns and is not for the benefit of, nor may any provision hereof be enforced by, any other person.

 

7.10         Expenses.  The parties shall pay their own legal and other expenses in connection with the preparation, negotiation and execution of this Agreement and the consummation of the transactions contemplated herein.

 

7.11         Assignment.  Except as otherwise expressly provided herein, the provisions hereof shall inure to the benefit of, and be binding upon, the successors and permitted assigns of the parties hereto and shall inure to the benefit of and be enforceable by each person who shall be a holder of Registrable Securities from time to time; provided, however, that prior to the receipt by the Company of adequate written notice of the transfer of any Registrable Securities specifying the full name and address of the transferee and providing the transferee’s agreement to be bound by the terms and conditions of this Agreement, the Company may deem and treat the person listed as the holder of such shares in its records as the absolute owner and holder of such shares for all purposes.  Neither party may assign its rights or delegate its duties under this Agreement without the prior written consent of the other party, which consent shall not be unreasonably withheld, conditioned or delayed; provided, however, that following the Closing Date, (i) the Investor may assign all of its rights and delegate all of its duties under this Agreement without the Company’s consent to an Affiliate (as defined in the License Agreement) or to a successor to all or substantially all of the business to which the License Agreement relates, whether by merger, sale of stock, sale of assets or other transaction, (ii) the Company may assign all of its rights and delegate all of its duties under this Agreement without the Investor’s consent to its successor, whether by merger, sale of stock, sale of assets or other transaction and (iii) subject to the foregoing notice provisions, each person who shall be a holder of Registrable Securities from time to time shall be assigned the rights, and delegated the duties, applicable to such Registrable Securities.  The name of a party appearing herein shall be deemed to include the names of such party’s successors and permitted assigns to the extent necessary to carry out the intent of this Agreement.  Notwithstanding any other provision of this Agreement, the rights to cause the Company to register Registrable Securities granted to a Holder by the Company under Article VI may be transferred or assigned by a Holder only to a transferee or assignee acquiring at least 200,000 shares of Registrable Securities (as presently constituted and subject to subsequent adjustments for stock splits, stock dividends, reverse stock splits and the like).

 

[signature page follows]

 

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IN WITNESS WHEREOF, the parties hereto have executed this Stock Purchase Agreement as of the date first written above.

 

 

ADVANCED LIFE SCIENCES HOLDINGS, INC.

 

 

 

 

 

By:

 /s/ Michael T. Flavin

 

     Name: Michael T. Flavin, Ph.D

 

     Title: Chief Executive Officer

 

 

 

 

 

WYETH

 

 

 

 

 

By:

 /s/ Thomas Hofstaetter

 

     Name: Thomas Hofstaetter

 

     Title: Senior VP, Corporate Business Development

 

 

Signature Page Stock Stock Purchase Agreement

 



 

EXHIBIT A

 

Matters to be Covered by Legal Opinion

 

1.             The Company is a corporation validly existing under Delaware law and in good standing with the Secretary of the State of Delaware and has the corporate power to execute and deliver the Agreement and to perform its obligations thereunder.

 

2.             The Company has duly authorized, executed and delivered the Agreement, and the Agreement constitutes the Company’s valid and binding agreement enforceable against the Company in accordance with its terms, except as enforceability may be limited by bankruptcy, insolvency, reorganization, moratorium or similar laws relating to or affecting creditors’ rights generally or by general equitable principles.

 

3.             No consent, approval, authorization or order of, or any filing or declaration with, any court or governmental agency or body is required in connection with the execution, delivery and performance of the Agreement by the Company or in connection with the taking by the Company of any action contemplated thereby, other than as indicated in the Agreement or such as have been obtained and made and such as may be required under federal and state securities laws.

 

4.             The execution, delivery and performance of the Agreement by the Company, and the consummation by the Company of the transactions contemplated therein, do not and will not (a) violate the certificate of incorporation or byaws of the Company, (b) materially violate any judgment, ruling, decree or order known to such counsel, (c) materially violate any statute or regulation applicable to the business or properties of the Company or (d) result in a material breach or violation of any of the terms or provisions of, or constitute a default or result in the acceleration of any obligation under, any material contract to which the Company is a party or bound.

 

5.             The Shares delivered on the date hereof have been duly authorized and, upon receipt of the agreed upon consideration therefor, will be validly issued, fully paid and non-assessable shares of the Company, free of any preemptive rights.

 


EX-10.1 5 a08-24714_1ex10d1.htm EX-10.1

Exhibit 10.1

 

[LEADERS BANK LETTERHEAD]

 

Michael T. Flavin, PhD

Chief Executive Officer

Advanced Life Sciences, Inc.

1440 Davey Rd.

Woodridge, IL.  60517

 

September 29, 2008

 

Dear Dr. Flavin:

 

The Leaders Bank has reviewed your loan application and hereby offers to amend and increase the existing line of credit extended to Advanced Life Sciences, Inc under the following terms and conditions:

 

Amount:

 

$10,000,000 (an increase of $6,000,000)

 

 

 

Term:

 

27 Months. Principal shall be due and payable in one lump sum on Maturity Date (see below). The line of credit will include a revolving feature to it. In addition, the Leaders Bank hereby agrees to waive all rights to call this debt upon Demand except if an event of default exists as described in the loan documents.

 

 

 

Maturity Date:

 

January 1, 2011 (formerly January 1, 2010)

 

 

 

Interest Rate:

 

8.5% Fixed

 

 

 

Collateral:

 

All Business Assets of Advanced Life Sciences, Inc., as defined in the current commercial security agreement of April 18, 2006, the pledge by ALS Ventures of 2,540,000 shares of Advanced Life Sciences Holdings, Inc Common Stock

 

 

 

Repayment:

 

Interest Only Monthly, Principal due at maturity

 

 

 

Closing Fee:

 

Warrants for 65,000 shares of Advanced Life Sciences, Inc Common Stock with a strike price of $1/ share.

 

 

 

Covenants:

 

Any cumulative sales exceeding $9 million under the $15 million Standby Equity Distribution Agreement (SEDA) currently in place between the Company and YA Global Investments, L.P. will not be utilized without the prior written consent of The Leaders Bank.

 



 

Other:

 

All other terms and conditions shall remain substantially the same as the terms agreed to in the current loan agreement scheduled to mature on 1-1-2010.

 

 

 

Commitment

 

 

Expiration Date:

 

 

 

 

This Commitment expires on 10-31-08. Subject to the terms and conditions of this Commitment, the loan will be documented and closed in a timely manner after all conditions of the Commitment have been satisfied. Funding shall also be conditioned upon the continuing accuracy of the facts and representations of the loan application of submission upon which this Commitment is based and the fulfillment of all of the terms and conditions herein. Lender reserves the right to terminate this commitment at any time prior to the closing of the loan in the event of an adverse change in the financial status of the Borrower and/or Guarantor, or if the collateral is damaged or destroyed.

 

 

 

Commitment

 

 

& Acceptance:

 

Subject to the terms and conditions stated herein, the Commitment is an offer that may be accepted by you until 10-7-08. Acceptance shall be signified by executing and returning to Lender a copy of this Commitment. No other form of acceptance will be effective.

 

 

Sincerely,

 

 

 

/s/ John J. Prosia

 

 

 

John J. Prosia

 

Executive Vice President

 

 

 

 

 

Accepted this 29 day of September, 2008

 

 

 

 

 

By:

    /s/ Michael T. Flavin

 

 

 

 

 

 

    Chief Executive Officer

 

 


EX-99.1 6 a08-24714_1ex99d1.htm EX-99.1

Exhibit 99.1

 

1440 Davey Road
Woodridge, IL 60517
(Phone) 630.739.6744
(Fax) 630.739.6754
www.advancedlifesciences.com

 

 

Company Contact: Joe Camp 630-754-4352

Email: jcamp@advancedlifesciences.com

October 1, 2008

Media Contact: Melanie Nimrodi, Financial Relations Board, 312-546-3508

Email: mnimrodi@frbir.com

Investors Contact: Kathy Price, Financial Relations Board, 213-486-6547

Email: kprice@frbir.com

 

CHICAGO, IL, Oct. 1, 2008/PRNewswire- FirstCall/: — Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), have signed a development and commercialization agreement for cethromycin in the Asia Pacific region excluding Japan.  Cethromycin is a novel once-a-day oral antibiotic for the treatment of community respiratory tract infections.  Advanced Life Sciences will retain exclusive rights to cethromycin in the rest of the world, including North America and Europe and excluding Japan(1).  Advanced Life Sciences separately announced the submission of a new drug application (NDA) to the U.S. FDA for cethromycin for the indication of mild-to-moderate community acquired pneumonia (CAP).

 

Under the terms of the agreement, Wyeth made an up-front equity investment in Advanced Life Sciences through the purchase of common stock representing approximately 4.9% of the Company’s total outstanding shares.  In addition to future royalty payments, Advanced Life Sciences would receive milestone and regulatory payments based on successful achievement of clinical, regulatory and commercial objectives in specific markets.  Advanced Life Sciences and Wyeth will collaborate to develop additional clinical data in the Asia Pacific region to support regulatory filings in that region.  The overall value of the transaction could potentially exceed $100 million.

 

“We are very pleased to be working with Wyeth to support development and commercialization efforts in the Asia Pacific region.  We believe this partnership validates our scientific achievements and the commercial potential for cethromycin,” said Michael T. Flavin, Ph.D., the Company’s chairman and chief executive officer.  “The need for new antibiotics and subsequent market growth in this region is outpacing that of the rest of the world due to high bacterial resistance rates.  Wyeth is a worldwide leader in the development and commercialization of novel respiratory therapeutics with a strong position in the Asia Pacific region and we are excited to be working with their team to be successful in bringing cethromycin to this key geography.”

 

“Antibiotic resistance in the community is a serious public health problem worldwide.  Data suggest that cethromycin has a favorable efficacy and safety profile in community acquired pneumonia and we view this product as a potential o ption to aid in the battle against potentially deadly pathogens,” said Mark Larsen, President, Asia-Pacific and Nutritionals, for Wyeth.  “If approved, we view cethromycin as an excellent addition to our strong portfolio of existing anti-infective agents, Tygacil(R) (tigecyline) and Zosyn(R) (piperacillin/tazobactam), and it is in line with our corporate objectives in a key growth region for Wyeth.”

 

About Cethromycin

 

Cethromycin has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract infections. In in vitro tests, cethromycin appears

 



 

to be effective against penicillin- and macrolide-resistant bacteria. Cethromycin has a mechanism of action that may slow the ability of bacteria to develop resistance to the drug.

 

In addition to its utility in CAP, cethromycin is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure and other pathogens of bioterror including tularemia, plague and melioidosis. The FDA has designated cethromycin as an orphan drug for the prophylactic treatment of inhalation anthrax post-exposure, but the drug is not yet approved for this or any other indication.

 

About Community Acquired Pneumonia (CAP)

 

CAP is the sixth most common cause of death in the United States. CAP and other respiratory tract infections are caused by pathogens such as Streptococcus pneumoniae and Haemophilus influenzae.  If not treated properly, CAP is potentially fatal and the bacteria that cause CAP are developing resistance to current standard of care treatments.

 

Macrolides and penicillins are currently the first-line treatments for respiratory tract infections such as CAP.  Streptococcus pneumoniae is the most prevalent pathogen that causes CAP and resistance rates to this organism range between 40% for macrolides and 60% for penicillins in the U.S.  Streptococcus pneumoniae resistance is more common in the Asia Pacific region, where rates exceed 50% for penicillin and 80% for macrolides. As macrolide and penicillin resistance grows and has the potential to cause more clinical failures, there is a need for new antibiotics with unique mechanisms of action that can overcome emerging bacterial resistance.

 

About Advanced Life Sciences

 

Advanced Life Sciences is a pre-commercial stage biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and respiratory diseases.  The Company’s lead candidate, cethromycin, is a novel once-a-day oral antibiotic in late-stage clinical development for the treatment of respiratory tract infections including CAP.  For more information, please visit http://www.advancedlifesciences.com.

 

(1) Abbott Laboratories retains rights to cethromycin in Japan.

 

Forward-Looking Statements

 

Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements represent our management’s judgment regarding future events.  The Company does not undertake any obligations to update any forward-looking statements whether as a result of new information, future events or otherwise.  Our actual results could differ materially from those discussed herein due to several factors including the our ability to obtain and maintain regulatory approval and labeling of our product candidates; our plans to develop and commercialize our product candidates; the loss of key scientific or management personnel; the size and growth of potential markets for our product candidates and our ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of our estimates regarding expenses, future revenues and capital requirements; our ability to obtain financing on terms acceptable to us; our ability to obtain and maintain intellectual property protection for our product candidates; the successful development of our sales and marketing capabilities; the success of competing drugs that become available; and the performance of third party collaborators and manufacturers.  These and additional risks and uncertainties are detailed in the Company’s filings with the Securities and Exchange Commission.

 

###

 


EX-99.2 7 a08-24714_1ex99d2.htm EX-99.2

Exhibit 99.2

 

1440 Davey Road
Woodridge, IL 60517
(Phone) 630.739.6744
(Fax) 630.739.6754
www.advancedlifesciences.com

 

 

 

Company Contact: Joe Camp 630-754-4352

October 3, 2008

 

Media Contact: Melanie Nimrodi, Financial Relations Board, 312-546-3508
Investors Contact: Kathy Price, Financial Relations Board, 213-486-6547

 

Advanced Life Sciences Announces Receipt of Nasdaq Staff Letter

 

CHICAGO, IL, October 3, 2008/PRNewswire/: — Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), today announced that on October 1, 2008 the Nasdaq Listings Qualifications Department informed the Company that the market value of its listed securities was below $35 million for 10 consecutive days, which is the requirement for continued listing on the Nasdaq Capital Market according to Marketplace Rule 4310(c)(3)(B).  Nasdaq also informed the Company that it is not in compliance with Marketplace Rule 4310(c)(3)(A) or 4310(c)(3)(C), which require minimum stockholders’ equity of $2,500,000 or net income from continuing operations of $500,000 in the most recently completed fiscal year or in two of the last three most recently completed fiscal years.

 

Advanced Life Sciences has been provided 30 calendar days, or until October 31, 2008, to regain compliance with the continued listing requirements of the Nasdaq Capital Market.  If at anytime prior to October 31, 2008, the market value of listed securities of the Company’s common stock is $35 million or more for a minimum of 10 consecutive business days, this could constitute meeting the criteria for continued listing on the Nasdaq Capital Market.

 

In the event that the Company does not regain compliance by October 31, 2008, Advanced Life Sciences will have the right to appeal a determination to delist its securities from the Nasdaq Capital Market.  The Company’s securities would remain listed on the Nasdaq Capital Market throughout the appeal process.

 

About Advanced Life Sciences

 

Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and inflammation.  The Company’s lead candidate, cethromycin, is a novel once-a-day antibiotic in pre-commercial development for the treatment of respiratory tract infections including mild-to-moderate community acquired pneumonia (CAP).  For more information, please visit us on the web at www.advancedlifesciences.com.

 

-MORE-

 



 

Forward-Looking Statements

 

Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  Except for historical information, the statements made in this press release are forward-looking statements about Advanced Life Sciences Holdings, Inc. Forward-looking statements represent our management’s judgment regarding future events and are accurate at the time they are made.  The Company does not undertake any obligations to update any forward-looking statements whether as a result of new information, future events or otherwise.  Our actual results could differ materially from those discussed herein due to several factors including the success and timing of our clinical trials and our ability to obtain and maintain regulatory approval and labeling of our product candidates; our plans to develop and commercialize our product candidates; the loss of key scientific or management personnel; the size and growth of potential markets for our product candidates and our ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of our estimates regarding expenses, capital requirements, and our ability to access capital through partnerships, stock offerings and future revenues; our ability to obtain and maintain intellectual property protection for our product candidates; the successful development of our sales and marketing capabilities; the success of competing drugs that become available; and the performance of third party collaborators and manufacturers.  These and additional risks and uncertainties are detailed in the Company’s filings with the Securities and Exchange Commission.

 

###

 


EX-99.3 8 a08-24714_1ex99d3.htm EX-99.3

Exhibit 99.3

 

1440 Davey Road
Woodridge, IL 60517
(Phone) 630.739.6744
(Fax) 630.739.6754
www.advancedlifesciences.com

 

 

 

Company Contact: Joe Camp 630-754-4352
Email: jcamp@advancedlifesciences.com

October 1, 2008

 

Media Contact: Melanie Nimrodi, Financial Relations Board, 312-546-3508
Email: mnimrodi@frbir.com
Investors Contact: Kathy Price, Financial Relations Board, 213-486-6547
Email: kprice@frbir.com

 

Advanced Life Sciences Announces NDA Submission for Cethromycin In

Community Acquired Pneumonia

 

CHICAGO, IL, October 1, 2008/PRNewswire-FirstCall/: Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), today announced the submission of a new drug application (NDA) today for cethromycin in mild-to-moderate community acquired pneumonia (CAP).  Advanced Life Sciences also entered into debt and equity financing agreements to strengthen its balance sheet and help fund commitments associated with the NDA submission and pre-commercialization activities.

 

CAP is the sixth most common cause of death in the United States. CAP and other respiratory tract infections are caused by pathogens such as Streptococcus pneumoniae and Haemophilus influenzae. CAP affects 5.6 million patients in the United States each year, with 10 million physician visits and 2 million hospitalizations occurring annually.

 

Macrolides and penicillins are currently the front-line treatments for respiratory tract infections such as CAP.   As macrolide and penicillin resistance grows and has the potential to cause more clinical failures, there is a need for new antibiotics with unique mechanisms of action that can overcome this emerging resistance.

 

“We are excited to make our NDA submission for cethromycin in mild-to-moderate CAP,” said Michael T. Flavin, Ph.D., the Company’s chief executive officer.  “Our team has worked tirelessly to complete this important objective for the cethromycin program.  We look forward to advancing the cethromycin NDA through the FDA review process.”

 

The NDA submission is based on a full clinical development and manufacturing program for cethromycin.  The program included two global Phase III pivotal studies for the treatment of mild-to-moderate CAP in which cethromycin was dosed at 300 milligrams once daily for seven days compared to the standard of care therapy, Biaxin, which was dosed at 250 milligrams twice daily for seven days.  The data from these trials showed that cethromycin was non-inferior to Biaxin with a similar safety profile.  The most common adverse reactions for cethromycin were taste disturbance, diarrhea, nausea and headache.

 

More than 5,000 patients have been treated with cethromycin in 53 clinical trials to date.

 

In conjunction with the NDA submission, the Company has received a commitment to increase availability under its loan facility with Leaders Bank from $4 million to $10 million.  The commitment provides that the loan would mature on January 1, 2011 and contain substantially similar terms and conditions as the existing loan agreement between Advanced Life Sciences and Leaders Bank.  Advanced Life Sciences has also agreed to issue to Leaders as a closing fee warrants for the purchase of 65,000

 



 

shares of its common stock at an exercise price of $1 per share. Consummation of the increased loan facility is subject to entering into definitive agreements and other customary closing conditions.

 

Advanced Life Sciences has also entered into a standby equity distribution agreement (SEDA) with YA Global Investments, L.P. (Yorkville) for the sale of up to $15 million of shares of the Company’s common stock over a two-year period.

 

“The SEDA is an instrument that allows us financial flexibility while we advance our ongoing regulatory, partnering and pre-commercial activities for cethromycin,” said John L. Flavin President and CFO of Advanced Life Sciences. “Our ability to choose if, and when, to access funds under the SEDA facility provides us with flexibility and the potential to minimize dilution for our stockholders.”

 

Under the terms of the SEDA, Advanced Life Sciences may from time to time, in its discretion, sell newly-issued shares of its common stock to Yorkville at a discount to market of 5%.   The amount of each advance is generally limited to $400,000 in any weekly period.   Advanced Life Sciences is not obligated to utilize any of the $15 million available under the SEDA and there are no minimum commitments or minimum use penalties.

 

Based upon the Company’s currently outstanding shares of common stock, and options and warrants to purchase common stock, the aggregate number of shares that Advanced Life Sciences may sell under the SEDA without stockholder approval is currently limited to approximately 5.3 million shares.  Unless stockholder approval is sought and obtained, the total amount of funds that ultimately can be raised under the SEDA over the two-year term will depend on the then-current price for Advanced Life Sciences’ stock and the number of shares actually sold. Advanced Life Sciences’ new credit agreement with Leaders will also contain a covenant limiting the Company’s utilization of the SEDA to $9 million without Leaders’ prior consent.

 

The SEDA does not impose any restrictions on the Company’s operating activities. During the term of the SEDA, Yorkville is prohibited from engaging in any short selling or derivative transactions related to the Company’s common stock.   Advanced Life Sciences issued 393,339 shares of common stock to Yorkville as a commitment fee in connection with entering into the SEDA.  Advanced Life Sciences also agreed to file with the SEC a registration statement, the effectiveness of which is a condition to the purchase and sale of any shares, with respect to common stock issuable under the SEDA.

 

The Company will discuss today’s news in a conference call with investors at 9:00 a.m. ET today.

 

Conference Call Details

 

The conference call will be webcast live over the Internet. To access the webcast, visit the Investor Relations section of the Advanced Life Sciences corporate website at http://www.advancedlifesciences.com. Alternatively, investors may participate in the conference call by dialing 888-679-8018 (domestic) or 617-213-4845 (international). The passcode for the conference call is 99287584. A replay of the conference call will be available until October 8, 2008. Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 29205976. Investors are advised to dial into the call at least ten minutes prior to the call to register. Participants may pre-register for the call at https://www.theconferencingservice.com/prereg/key.process?key=P88ATW9XX. Pre-registrants will be issued a pin number to use when dialing into the live call which will provide quick access to the conference by bypassing the operator upon connection.

 



 

About Cethromycin

 

Cethromycin has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract infections, and, again in in vitro tests, it appears to be effective against penicillin- and macrolide-resistant bacteria. Cethromycin has a mechanism of action that may slow the onset of future bacterial resistance. In addition to its utility in CAP, cethromycin is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure.

 

About Advanced Life Sciences

 

Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and respiratory diseases.  The Company’s lead candidate, cethromycin, is a novel once-a-day oral antibiotic in pre-commercial development for the treatment of respiratory tract infections including CAP.  For more information, please visit us on the web at http://www.advancedlifesciences.com.

 

Forward-Looking Statements

 

Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements represent our management’s judgment regarding future events.  The Company does not undertake any obligations to update any forward-looking statements whether as a result of new information, future events or otherwise.  Our actual results could differ materially from those discussed herein due to several factors including the our ability to obtain and maintain regulatory approval and labeling of our product candidates; our plans to develop and commercialize our product candidates; the loss of key scientific or management personnel; the size and growth of potential markets for our product candidates and our ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of our estimates regarding expenses, future revenues and capital requirements; our ability to obtain financing on terms acceptable to us; our ability to obtain and maintain intellectual property protection for our product candidates; the successful development of our sales and marketing capabilities; the success of competing drugs that become available; and the performance of third party collaborators and manufacturers.  These and additional risks and uncertainties are detailed in the Company’s filings with the Securities and Exchange Commission.

 


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