Unassociated Document
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: August 1, 2007 
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HEALTHCARE ACQUISITION CORP.
---------------------------
(Exact Name of Registrant as Specified in Charter)

Delaware 
 
 001-32587 
 
 20-2726770
(State or Other Jurisdiction
 
(Commission
 
(IRS Employer
of Incorporation)
 
File Number)
 
Identification No.)
         
2116 Financial Center 666 Walnut Street
   
Des Moines, Iowa  
 
50309
(Address of Principal Executive Offices)
 
(Zip Code)

Registrant's telephone number, including area code: (515) 244-5746
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Not Applicable
--------------
(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 (see General Instruction A.2. below):

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 8.01 Other Events. 

On August 1, 2007, Healthcare Acquisition Corp. (“Healthcare”) announced that on August 1, 2007, it filed with the SEC and mailed to its stockholders of record as of the record date of June 15, 2007, supplemental information to its definitive proxy statement (the “Supplement”) with respect to a Special Meeting of stockholders to be held on August 2, 2007. A copy of the Supplement is attached hereto as Exhibit 99.1. A copy of the press release for such announcement is attached to this Report as Exhibit 99.2
 

Item 9.01
Financial Statements and Exhibits.

(d)

Name
Description
   
Exhibit 99.1
Proxy Supplement filed with the SEC on August 1, 2007
Exhibit 99.2
Press Release dated August 1, 2007

 
SIGNATURE


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.


Dated: August 1, 2007
 HEALTHCARE ACQUISITION CORP.
 
       
       
       
 
By:
 /s/ Matthew P. Kinley
 
 
 
Matthew P. Kinley
 
 
 
President
 
 
Unassociated Document Exhibit 99.1
 

HEALTHCARE ACQUISITION CORP.
2116 Financial Center
666 Walnut Street
Des Moines, Iowa 50309


Supplement To Proxy Statement
of
HealthCare Acquisition Corp.
For
Special meeting of Stockholders
To be held on August 2, 2007

The date of this Supplement is August 1, 2007

To Our Stockholders:
 
On July 13, 2007 Healthcare Acquisition Corp. (“HAQ” or the “Company”) filed with the Securities and Exchange Commission and mailed to its stockholders its definitive proxy statement ( the “Proxy Statement”) with respect to a Special Meeting of Stockholders to be held on August 2, 2007 (the “Special Meeting”). As previously disclosed, stockholders of record as of June 15, 2007 (the “Record Date”) are entitled to attend and vote at the Special Meeting. The Special Meeting will be held at 10:00 a.m., Eastern Time, at the offices of McCarter & English, LLP, 245 Park Avenue, 27th Floor, New York, NY, 10167-0001.

This supplemental information to the Proxy Statement is being mailed on August 1, 2007 to its shareholders of record as of the Record Date. At the Special Meeting, stockholders are being asked to vote in favor of the following proposals, as more fully described in the Proxy Statement:
 
• the Merger Proposal — the proposed merger (“Merger”) with PharmAthene, Inc., a Delaware corporation (“PHA”), pursuant to the Agreement and Plan of Merger, dated as of January 19, 2007 (the “Merger Agreement”), by and among HAQ, PAI Acquisition Corp (“Merger Sub”) and PharmAthene, and the transactions contemplated thereby, whereby PharmAthene will become a wholly-owned subsidiary of HAQ (the “Merger Proposal”) and the stockholders, optionholders, warrantholders and noteholders of PharmAthene shall receive the following consideration (having an aggregate value of $112,500,000 if the maximum milestone payments are achieved and paid and assuming a price of $7.20 per share of HAQ common stock):
 
(i) an aggregate of 12,500,000 shares of HAQ common stock;
 
(ii) $12,500,000 in 8% convertible notes issued by HAQ; and
 
(iii) up to $10,000,000 in milestone payments (if certain conditions are met).
 
• the Amendment Proposal — the amendment to HAQ's amended and restated certificate of incorporation (the “Certificate of Incorporation Amendment”), to: (i) change HAQ's name from “Healthcare Acquisition Corp.” to “PharmAthene, Inc.”; (ii) remove certain provisions containing procedural and approval requirements applicable to HAQ prior to the consummation of the business combination that will no longer be operative after the consummation of the Merger; and (iii) grant to holders of convertible promissory notes issued in the Merger the right to designate three members to the Board of Directors of HAQ for so long as at least 30% of the original face value of such notes remain outstanding (the “Amendment Proposal”);
 



 
• the Incentive Plan Proposal — the adoption of the 2007 Long-Term Incentive Plan (the “Incentive Plan”) pursuant to which HAQ will reserve 3,500,000 shares of common stock for issuance pursuant to the Plan (the “Incentive Plan Proposal”);
 
• the Adjournment Proposal — the adjournment of the Special Meeting (the “Adjournment”), if necessary and appropriate, for the purpose of soliciting additional proxies if there are not sufficient votes for the foregoing proposals ( the “Adjournment Proposal”).

The Merger Proposal, the Amendment Proposal, the Incentive Plan Proposal and the Adjournment Proposal are explained in more detail in the Definitive Proxy Statement and are sometimes referred to collectively as the “Proposals”.

A copy of this supplement to the Proxy Statement has been filed as Exhibit 99.1 to the Report on Form 8-k filed by HAQ on August 1, 2007.

The Company, its principal stockholders and its advisors have been contacted by third party investors who have indicated to the Company that they may be interested in making an investment in the Company through the purchase of a significant number of shares of the Company’s common stock. Certain investors, one of which is Millenium Partners, L.P. (and/or one or more of its affiliated entities) (collectively referred to as “New Investors”) have indicated that they would be interested in making purchases of the Company’s common stock in privately negotiated transactions with existing stockholders of the Company, but would require that, in connection with the purchases, the New Investors receive additional shares of HAQ’s common stock from the founding stockholders of HAQ and from certain stockholders of PHA who will be receiving shares of HAQ common stock as a result of the Merger.

HAQ’s principal stockholders and management team expressed an interest in providing the New Investors with these additional shares provided that the Merger is approved, and have advised the New Investors that they must obtain the right to vote the shares to be purchased and vote any shares so purchased in favor of the Proposals or obtain from the sellers of such shares a vote in favor of the Proposals. As described in the Proxy Statement, the Merger Proposal requires that less than 1,880,000 shares vote against the Merger and demand conversion of their shares. As of August 1, 2007, HAQ believes that there are in excess of the 1,880,000 shares currently being cast against the Merger Proposal and the holders thereof electing to convert such shares and, therefore, the New Investors may be required to purchase a significant number of shares.  As previously disclosed in the Proxy Statement, it is also possible that members of management of HAQ and/or their affiliates may engage in private purchases of HAQ common stock prior to the Special Meeting.

HAQ’s management has  discussed the terms of the potential transaction with certain of PHA’s stockholders and management, as well as their respective advisors in the transaction, including Maxim Group LLC. These discussions were held over the several days from July 26, 2007 to August 1, 2007. HAQ’s management, its principal stockholders and several of the principal stockholders of PHA negotiated the terms of the proposed investment with the New Investors during such period and are continuing discussions with additional potential investors.




HAQ’s principal stockholders and certain stockholders of PHA, acting as individual stockholders, have agreed in principle to the terms as set forth below, which are a summary of all of the material terms of the proposed agreements that have been negotiated among the parties and which agreements are expected to be executed prior to the Special Meeting.:

1. The New Investors would agree to purchase, in the aggregate, up to 2,800,000 shares of the Company’s common stock in privately negotiated transactions with HAQ stockholders who were stockholders of HAQ as of the Record Date and who have either delivered proxy cards indicating a vote against the Merger Proposal or have advised HAQ and its advisors that they intend to vote against the Merger Proposal (sometimes referred to collectively as the “Opposing Shares”), with Millennium Partners, L.P. (either directly or through affiliated entities) purchasing a minimum of 1.2 million shares;

2. The Opposing Shares would be purchased at a price to be negotiated between the sellers and the New Investors, although it is expected that the per share price would be equal to or at a premium over the amount held in trust for the shares of common stock, which amount in trust is currently estimated at $7.60 per share;

3. The New Investors would obtain from the sellers of the Opposing Shares either a new proxy card changing any “no” votes against the Proposals to votes in favor of the Proposals or an agreement to vote any such Opposing Shares in favor of the Proposals;
 
4. Pursuant to contemplated purchase option agreements, John Pappajohn, Derace L. Schaffer M.D. Edward B. Berger, Wayne A. Schellhammer and Matthew Kinley, the founders of HAQ and its executive officers and directors prior to the Merger (collectively, the “HAQ Insiders”) would enter into agreements with the New Investors granting them options to acquire up to 1,266,752 shares of HAQ common stock in the aggregate (which amount may be reduced pro rata to the extent that less than 2,800,000 shares are purchased by the New Investors). The option would be purchased for an aggregate purchase price of $100 and the exercise price per share would be $.0001 per share. The options would not be exercisable until the underlying shares are released from the escrow arrangement with Continental Stock Transfer & Trust Company to which the HAQ Insiders are subject which will expire on July 28, 2008, assuming the Merger is approved. The HAQ Insiders entered into the escrow arrangement for all of their pre IPO shares in connection with the initial public offering by HAQ which was completed on July 28, 2005. The HAQ Insiders own an aggregate of 2,250,000 shares being held in escrow and had recently purchased an additional 250,000 shares pursuant to Rule 10b5-1 plans which are not included in the escrow and are not being sold to the New Investors. No option will be exercisable unless the Merger is approved. In the event that the New Investors purchase all of the 2,800,000 shares, the share ownership of the HAQ Insiders would be reduced as follows (assuming that such HAQ Insiders do not affect additional private purchases of HAQ common stock prior to the Special Meeting):

HAQ Insider
Number of Shares
Number of Shares
 
of HAQ common stock
of HAQ common stock
 
without giving effect
after giving effect to the
 
to the Proposed Transaction
Proposed Transaction
     
     
John Pappajohn
982,000
484,419
     
Derace L. Schaffer M.D.
982,000
484,419
     
Matthew Kinley
491,000
242,210
 
   
Edward B. Berger
22,500
11,100
     
Wayne A. Schellhammer
22,500
11,100




The option agreement would also provide that  neither the HAQ Insiders nor the New Investors would sell, transfer, pledge, assign or otherwise dispose of the options or the HAQ shares of common stock underlying the options while such options are subject to the escrow agreement and while the options remain exercisable. The options would be exercisable commencing upon the date that the pre IPO shares are released from the escrow agreement and have a term of one year from such date. It is also expected that the purchase option agreement would include a prohibition on each New Investor (together with any affiliated entities which might be deemed to be part of a group) exercising the option to the extent that any exercise would result in any New Investor (together with any affiliated entities which might be deemed to be part of a group) becoming the beneficial owner of more than 9.9% of the outstanding common stock of HAQ.
 
The HAQ Insiders are entitled to certain registration rights for their IPO Shares, as described in HAQ’s prospectus from its IPO and in the Proxy Statement. These rights provide that the holders of the majority of these pre IPO shares will be entitled to require HAQ, on up to two occasions, to register these shares. The holders of the majority of these shares may elect to exercise these registration rights at any time after the date on which the shares of common stock are released from the escrow. In addition, the HAQ insiders have certain “piggy-back” registration rights on registration statements filed subsequent to the date on which these shares of common stock are released from escrow. HAQ will bear the expenses incurred in connection with the filing of any such registration statements. The New Investors, as assignees of the HAQ Insiders of the pre IPO Shares, would be entitled to these registration rights.

5. Pursuant to an assignment agreement which is currently being negotiated, Healthcare Ventures III, L.P, funds affiliated with MPM Capital L.P. and funds affiliated with Bear Stearns Health Innoventures Management, LLC, all of which are stockholders of PHA, would agree to assign to the New Investors an aggregate of up to 479,252 shares that would otherwise be received by them as part of the Merger, assuming the Merger is consummated. Under the terms of the Merger Agreement , the number of shares issuable to the PHA stockholders could be adjusted upward by up to 337,500 shares of HAQ common stock (the “Adjustment Shares”) in the event that stockholders of HAQ holding in excess of 5% of the IPO shares of HAQ vote against the Merger and seek to convert their shares. These stockholders of PHA would assign their right to receive their pro rata portion of these Adjustment Shares (an aggregate of up to 211,797 shares) to the extent issuable under the terms of the Merger Agreement to the New Investors, as well as an additional 267,455 shares issuable to them, in the aggregate, under the Merger Agreement. The New Investors would be entitled, as assignees of the PHA stockholders, to the registration rights being granted to the stockholders of PHA under the terms of the Merger Agreement as described in the Proxy Statement. The effectiveness of the assignment would be contingent upon the Merger Proposal being approved. The New Investors would agree to enter into the lock up agreement being signed by all other PHA stockholders in connection with the Merger.
 
As a result of the transaction with the New Investors as described above, these PHA stockholders would own the shares of common stock of HAQ following the Merger described below, which compares the shares held without giving effect to the proposed transaction with the New Investors and after giving effect to the proposed transaction (but without giving effect to any Adjustment Shares):

Name of PHA Investor
Number of Shares
Number of Shares
 
of HAQ common stock
Of HAQ common stock
 
without giving effect
after giving effect to the
 
to the Proposed Transaction
Proposed Transaction 
     
 
   
Funds affiliated with
   
The Bear Stearns Health
   
Innoventures Management
   
LLC
1,357,744
1,311,451
     
Funds affiliated with
   
MPM Capital L.P.
3,331,851
3,218,251
     
Healthcare Ventures VII, L.P.
3,154,736
3,047,174 




 
HAQ has advised the New Investors that it would agree that if that if the shares held by the New Investors may not be sold without registration under the Securities Act of 1933, the Company would provide registration rights to the New Investors upon substantially the same terms as provided to the PHA stockholders under the terms of the Merger Agreement.
 
 
THE BOARD OF DIRECTORS RECOMMENDS THAT YOU VOTE IN FAVOR OF THE MERGER PROPOSAL AND ALL OTHER PROPOSALS AS SET FORTH IN THE PROXY STATEMENT DATED JULY 13, 2007.
 

Dated: August 1, 2007
 HEALTHCARE ACQUISITION CORP.
     
     
 
By:
/s/ John Pappajohn
 
 
John Pappajohn
 
 
Chairman

Unassociated Document


 
Contact:

Matthew P. Kinley
President
Healthcare Acquisition Corp.
515-244-5746

Stacey Jurchison
PharmAthene, Inc.
Phone: 410-571-8925
Cell: 410-474-8200
JurchisonS@pharmathene.com


HEALTHCARE ACQUISITION CORP.
ANNOUNCES FILING OF PROXY STATEMENT SUPPLEMENT

DES MOINES, IA and ANNAPOLIS, MD - August 1, 2007 - Healthcare Acquisition Corp. (AMEX: HAQ; HAQ.W), announced that a Proxy Statement Supplement was filed with the Securities and Exchange Commission on August 1, 2007 to provide supplemental information to the Proxy Statement with respect to a Special Meeting of the stockholders of Healthcare Acquisition Corp. (“HAQ” or the “Company”) scheduled to be held on August 2, 2007.

At the Special Meeting the Company’s stockholders will be asked to vote in favor of the acquisition of PharmAthene, Inc. (“PHA”) through the merger of the Company’s subsidiary into PHA (the “Merger”), as well as certain other proposals as described in the Proxy Statement dated July 13, 2007.

The Company has been informed by its principal stockholders that the principal stockholders, and certain stockholders of PHA, have reached a tentative agreement with certain third party investors who have agreed to purchase up to 2,800,000 shares of the Company’s common stock. Certain investors, one of which is Millenium Partners, L.P. Group (and/or one or more of its affiliated entities) (collectively referred to as “New Investors”) have indicated that they would be interested in making purchases of the Company’s common stock in privately negotiated transactions with existing stockholders of the Company, but would require that, in connection with the purchases, the New Investors receive additional shares of HAQ’s common stock from the founding stockholders of HAQ and from certain stockholders of PHA who will be receiving shares of the Company’s common stock as a result of the Merger.

HAQ’s principal stockholders and certain stockholders of PHA, acting as individual stockholders, have agreed in principle to the terms as set forth below, which are a summary of all of the material terms of the proposed agreements that have been negotiated among the parties and which agreements are expected to be executed prior to the Special Meeting:



1. The New Investors would agree to purchase, in the aggregate, up to 2,800,000 shares of the Company’s common stock in privately negotiated transactions with HAQ stockholders who were stockholders of HAQ as of the Record Date and who have either delivered proxy cards indicating a vote against the Merger Proposal or have advised HAQ and its advisors that they intend to vote against the Merger Proposal (sometimes referred to collectively as the “Opposing Shares”) with Millenium Partners, LP. (either directly or through affiliated entities) purchasing a minimum of 1.2 million shares;

2. The Opposing Shares would be purchased at a price to be negotiated between the sellers and the New Investors, although it is expected that the per share price would be equal to or at a premium over the amount held in trust for the shares of common stock, which amount in trust is currently estimated at $7.60 per share;

3. The New Investors would obtain from the sellers of the Opposing Shares either a new proxy card changing any “no” votes against the Proposals to votes in favor of the Proposals or an agreement to vote any such Opposing Shares in favor of the Proposals.

Pursuant to contemplated purchase option agreements John Pappajohn, Derace L. Schaffer M.D. Edward B. Berger, Wayne A. Schellhammer and Matthew Kinley, the founders of HAQ and its executive officers and directors prior to the merger (collectively, the “HAQ Insiders”) would enter into agreements with the New Investors granting them options to acquire up to 1,266,752 shares of HAQ common stock in the aggregate (which amount may be reduced pro rata to the extent that less than 2,800,000 shares are purchased by the New Investors). The option would be purchased for an aggregate purchase price of $100 and the exercise price per share would be $.0001. The options would not be exercisable until the underlying shares are released from the escrow arrangement with Continental Stock Transfer & Trust Company to which the HAQ Insiders are subject which will expire on July 28, 2008, assuming the Merger is approved. The HAQ Insiders entered into the escrow arrangement for all of their pre IPO shares in connection with the initial public offering by HAQ which was completed on July 28, 2005. The HAQ Insiders own a total aggregate of 2,250,000 shares being held in escrow and had recently purchased 250,000 shares pursuant to Rule 10b5-1 plans which are not included in the escrow and are not being sold to the New Investors. No option will be exercisable unless the Merger is approved.

Pursuant to an assignment agreement which is currently being negotiated, certain stockholders of PHA would agree to assign to the New Investors an aggregate of up to 479,272 shares that would otherwise be received by them as part of the Merger, assuming the Merger is consummated. Under the terms of the Merger Agreement, the number of shares issuable to the PHA stockholders could be adjusted upward by up to 337,500 shares of HAQ common stock (the “Adjustment Shares”) in the event that stockholders of HAQ holding in excess of 5% of the IPO shares of HAQ vote against the Merger and seek to convert their shares. These stockholders of PHA would assign their pro rata portion of these additional shares (an aggregate of up to 211,797 shares to the extent issuable under the terms of the Merger Agreement) to the New Investors, as well as an additional 267,455 shares issuable to them in the aggregate under the Merger Agreement. The New Investors would be entitled, as assignees of the PHA stockholders, to the registration rights being granted to the stockholders of PHA under the terms of the Merger Agreement as described in the Proxy Statement. The effectiveness of the assignment would be contingent upon the Merger Proposal being approved. The New Investors would agree to enter into the lock up agreement being signed by all other PHA stockholders in connection with the Merger.
 
Healthcare Acquisition has filed a Proxy Statement Supplement with the SEC detailing the transactions described in this release and containing the above-referenced agreements. You are urged to review it carefully.





About PharmAthene, Inc.

PharmAthene, a privately-held biotechnology company, was formed to meet the critical needs of the United States by developing biodefense products. PharmAthene is dedicated to the rapid development of important and novel biotherapeutics to address biological pathogens and chemicals that may be used as weapons of bioterror. PharmAthene’s lead programs include Valortim™ (being co-developed with Medarex [NASDAQ:MEDX]) and Protexia®. PharmAthene is located in the Chesapeake Innovation Center in Annapolis, MD, the first technology incubator focused solely on Homeland Security. For more information on PharmAthene, please visit its website at www.PharmAthene.com.

About Healthcare Acquisition Corp.

Des Moines-based Healthcare Acquisition Corp. a company was formed by healthcare investing pioneer merchant banker John Pappajohn as a business combination company focused on the healthcare industry. The Company raised $ 75.2 million in gross proceeds through an initial public offering completed in July, 2005, of which $67,928,000 was placed in trust. As of March 31, 2007, the Company held approximately $71.4 million in trust. The Company’s shares trade on the American Stock Exchange under the symbol HAQ and its warrants trade on the American Stock Exchange under the symbol HAQ.W.  
 
Additional Information
 
HAQ AND ITS DIRECTORS AND EXECUTIVE OFFICERS AS WELL AS PHARMATHENE AND ITS DIRECTORS AND EXECUTIVE OFFICERS MAY BE DEEMED TO BE PARTICIPANTS IN THE SOLICIATION OF PROXIES FOR THE SPECIAL MEETING OF HAQ'S STOCKHOLDERS TO BE HELD TO APPROVE THE PROPOSED MERGER. SECURITYHOLDERS AND OTHER INTERESTED PERSONS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT REGARDING THE PROPOSED MERGER FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON JULY 13, 2007, AS THEY CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED MERGER. STOCKHOLDERS WILL ALSO BE ABLE TO OBTAIN A COPY OF THE DEFINITIVE PROXY STATEMENT, WITHOUT CHARGE, BY DIRECTING A REQUEST TO HAQ AT: 2116 FINANCIAL CENTER, 666 WALNUT STREET, DES MOINES, IOWA 50309. THE DEFINITIVE PROXY STATEMENT AND THE FINAL PROSPECTUS AND OTHER SEC FILINGS OF HAQ CAN ALSO BE OBTAINED, WITHOUT CHARGE, AT THE SECURITIES AND EXCHANGE COMMISSION'S INTERNET SITE (http://www.sec.gov).
 



 
HAQ AND PHARMATHENE CLAIM THE PROTECTION OF THE SAFE HARBOR FOR "FORWARD-LOOKING STATEMENTS" WITHIN THE MEANING OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. FORWARD-LOOKING STATEMENTS ARE STATEMENTS THAT ARE NOT HISTORICAL FACTS. SUCH FORWARD-LOOKING STATEMENTS, BASED UPON THE CURRENT BELIEFS AND EXPECTATIONS OF MANAGEMENT OF HAQ AND PHARMATHENE REGARDING, AMONG OTHER THINGS, THE BUSINESS OF PHARMATHENE AND THE MERGER, ARE SUBJECT TO RISKS AND UNCERTAINTIES, WHICH COULD CAUSE ACTUAL RESULTS TO DIFFER FROM THE FORWARD-LOOKING STATEMENTS. RISKS AND UNCERTAINTIES INCLUDE RISKS ASSOCIATED WITH THE RELIABILITY OF THE RESULTS OF THE INITIAL WORK CONDUCTED ON VALORTIM(TM) RELATING TO ANIMAL EFFICACY, HUMAN SAFETY AND LIKELIHOOD OF SUCCESSFUL DEVELOPMENT OF AN EFFICIENT AND SCALABLE MANUFACTURING PROCESS, UNEXPECTED FUNDING DELAYS BY NIAID, UNFORESEEN SAFETY ISSUES RESULTING FROM THE HANDLING OF BACILLUS ANTHRACIS, UNFORESEEN SAFETY ISSUES RESULTING FROM THE ADMINISTRATION OF VALORTIM(TM) (MDX-1303) IN HUMAN SUBJECTS, UNCERTAINTIES RELATED TO PRODUCT MANUFACTURING. THERE CAN BE NO ASSURANCE THAT SUCH DEVELOPMENT EFFORTS WILL SUCCEED OR THAT OTHER DEVELOPED PRODUCTS WILL RECEIVE REQUIRED REGULATORY CLEARANCE OR THAT, EVEN IF SUCH REGULATORY CLEARANCE WERE RECEIVED, SUCH PRODUCTS WOULD ULTIMATELY ACHIEVE COMMERCIAL SUCCESS.