-----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, FL/b+DMtiweAjgSBc1ydI14vJPO+eBxClXUEPYKcxqc1N7CC3kUqqdLoKqVcd3Ct caxXfe3SSiWg/d/gj64icA== 0000950133-07-004269.txt : 20071026 0000950133-07-004269.hdr.sgml : 20071026 20071026134333 ACCESSION NUMBER: 0000950133-07-004269 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20071022 ITEM INFORMATION: Termination of a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071026 DATE AS OF CHANGE: 20071026 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NOVAVAX INC CENTRAL INDEX KEY: 0001000694 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 222816046 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-26770 FILM NUMBER: 071192946 BUSINESS ADDRESS: STREET 1: 9920 BELWARD CAMPUS DRIVE CITY: ROCKVILLE STATE: MD ZIP: 20850 BUSINESS PHONE: 240-268-2000 MAIL ADDRESS: STREET 1: 9920 BELWARD CAMPUS DRIVE CITY: ROCKVILLE STATE: MD ZIP: 20850 8-K 1 w41388e8vk.htm FORM 8-K e8vk
 

 
 
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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): October 22, 2007
NOVAVAX, INC.
(Exact name of Registrant as specified in its charter)
         
Delaware
(State or other jurisdiction of incorporation or organization)
  0-26770
(Commission File Number)
  22-2816046
(I.R.S. Employer Identification No.)
     
9920 Belward Campus Drive
Rockville, Maryland
(Address of principal executive offices)
  20850
(Zip Code)
     
Registrant’s telephone number, including area code:     
(240) 268-2000
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:
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 1.02   Termination of a Material Definitive Agreement
On October 22, 2007, Novavax, Inc. (“Novavax”) and Allergen, Inc. (“Allergen”), successor in interest to Esprit Pharma, Inc. entered into an agreement (the “ESTRASORB Termination Agreement”) to terminate the Supply Agreement dated as of October 18, 2005, as amended, related to the supply of ESTRASORB by Novavax to Allergen (the “ESTRASORB Agreement”) effective October 22, 2007. Pursuant to the ESTRASORB Agreement, Novavax manufactured and supplied ESTRASORB to Esprit. In a license agreement that is not being terminated, Esprit was granted an exclusive license to sell ESTRASORB in North America.
Also on October 22, 2007, Novavax and Allergen entered into an agreement (the “Testosterone Termination Agreement” and together with the ESTRASORB Termination Agreement, the “Termination Agreements”) to terminate the License and Development Agreement dated May 9, 2006 and the Supply Agreement dated May 9, 2006, each related to the development and potential supply of a testosterone product for use in women’s health (collectively, the “Testosterone Agreements”) effective October 22, 2007. The Testosterone Agreements called for Novavax to co-develop, supply and commercialize its micellar nanoparticle testosterone medicine for the treatment of female hypoactive sexual desire disorder. Esprit was granted exclusive rights to market the product in North America.
Based on discussions between Novavax and Allergen, the parties decided to mutually terminate the ESTRASORB Agreement and the Testosterone Agreements. The termination of these agreements is in line with Novavax’s corporate policy to focus on its vaccine business.
Pursuant to the ESTRASORB Termination Agreements, all rights and obligations of the parties terminate on the effective date, except for obligations related to confidentiality and indemnification. In addition, Novavax has agreed to ship all product on hand to Allergen and provide Allergen, at Allergen’s request, with the access and information necessary for a third party to manufacture ESTRASORB for three months following the effective date. Allergen has agreed to pay approximately $1.29 million to Novavax, primarily related to inventory on hand and certain other wind down costs. Allergen will also pay any additional direct out-of-pocket costs incurred by Novavax resulting from the termination of the ESTRASORB Agreement that is the direct result of Food and Drug Administration (the “FDA”) regulatory requirements in an amount not to exceed $100,000. Novavax has agreed to use its best efforts to return raw packaging material and will split any amounts received equally with Allergen.
Pursuant to the Testosterone Termination Agreement, all rights and obligations of the parties terminate on the effective date, except for obligations related to confidentiality and indemnification. All licenses granted to Esprit ceased and all licensed rights revert back to Novavax. Finally, both parties agreed to release any claims that has arisen or may arise under the Testosterone Agreements.
On October 25, 2007, Novavax issued a press release announcing the Termination Agreements. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01.   Financial Statements and Exhibits.
(d)   Exhibits
  99.1   Press Release issued by Novavax, Inc. dated October 25, 2007

2


 

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, thereunto duly authorized.
         
  Novavax, Inc.
(Registrant)
 
 
October 26, 2007  By:   /s/ Len Stigliano    
    Name:   Len Stigliano    
    Title:   Vice President, Chief Financial Officer, and Treasurer   
 

3

EX-99.1 2 w41388exv99w1.htm EXHIBIT 99.1 exv99w1
 

Exhibit 99.1
(NOVAVAX LOGO)
     
Contact:
  Tricia Richardson
 
  Novavax, Inc.
 
  240-268-2031
NOVAVAX AND ALLERGAN TERMINATE
MANUFACTURING SUPPLY AGREEMENT FOR ESTRASORB

Action allows Novavax to focus on its vaccine business and reduce cash burn
Rockville, MD - (October 25, 2007) —Novavax, Inc. (Nasdaq: NVAX) announced today that it has agreed with Allergan, Inc. to terminate its manufacturing supply agreement for Estrasorb. Estrasorb was previously licensed by Novavax to Esprit Pharma, Inc. (recently acquired by Allergan, Inc.) in 2006 and is an approved estrogen product for relief of moderate to severe vasomotor symptoms (hot flashes) associated with menopause. Under the termination agreement, Novavax will complete the manufacture of remaining orders for the product and plans to close its Philadelphia manufacturing facility over the next few months. Allergan will continue to sell Estrasorb for the foreseeable future from available inventory.
The goal to exit manufacturing of Estrasorb had been a high priority of the Company’s Board and management team since this activity was not strategic to the Company’s core vaccine business and was a cash drain to Novavax. The Company had continued manufacturing Estrasorb since it was tied to the product’s license agreement. Additionally, Allergan will return to Novavax the rights to develop ESP 210, an investigational drug in Phase II development for the treatment of hypoactive sexual desire disorder.
“We are focused on executing our vaccine business strategy and have previously stated that one of our highest corporate priorities is to divest the Company’s various non-vaccine product candidates and technologies. Today’s announcement terminating the Estrasorb supply agreement is in line with this corporate priority and will reallocate our cash to our core business, the development of new vaccines,” said Dr. Rahul Singhvi, Novavax’s President and CEO.
About Novavax
Novavax Inc. is committed to leading the global fight against infectious disease by creating novel, highly potent vaccines that are safer and more effective than current preventive options. Using the company’s proprietary virus-like particle (VLP) and Novasome® adjuvant technologies, Novavax is developing vaccines to protect against H5N1 pandemic influenza, seasonal flu and other viral diseases. Novavax’s particulate vaccines closely match disease-causing viruses while lacking the genetic material to cause disease, which provides potential for greater immune protection at lower doses than current vaccines. With an exclusive portable manufacturing system that allows for rapid mass-production of vaccines, Novavax is uniquely positioned to meet global public health needs. Additional information about Novavax is available at www.novavax.com and in the company’s various filings with the Securities and Exchange Commission.
Forward-Looking Statements
Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding product sales, operating expenses, and clinical developments are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by Novavax to secure and maintain relationships with collaborators; risks relating to the early stage of Novavax’s product candidates under development; uncertainties relating to clinical trials; risks relating to the commercialization, if any, of Novavax’s proposed product candidates; dependence on the efforts of third parties; dependence on intellectual property; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility, and risks that we may lack the financial resources and access to capital to fund our operations. Further information on the factors and risks that could affect Novavax’s business, financial conditions and results of operations, is contained in Novavax’s filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov. These forward-looking statements speak only as of the date of this press release, and Novavax assumes no duty to update forward-looking statements.
# # # # #

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