8-K 1 y80529e8vk.htm FORM 8-K e8vk
 
 
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): November 12, 2009
BIODEL INC.
(Exact name of registrant as specified in its charter)
Commission File Number 001-33451
     
Delaware   90-0136863
(State or other jurisdiction of incorporation or organization)   (IRS Employer Identification Number)
     
100 Saw Mill Road    
Danbury, Connecticut   06810
(Address of principal executive offices)   (Zip code)
(203) 796-5000
(Registrant’s telephone number, including area code)
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 1.01 Entry into a Material Definitive Agreement.
     On November 12, 2009, Biodel Inc. (the “Company”) and N.V. Organon (“Organon”) amended the supply agreement entered into between the parties on July 7, 2008 (the “Amendment”). Pursuant to the supply agreement (the “Supply Agreement”), Organon has agreed to sell and deliver to the Company, and the Company has agreed to purchase from Organon, specified quantifies of recombinant human insulin for use in the Company’s VIAdel™ insulin formulations.
     The Amendment extends the term of the Supply Agreement from December 2010 to December 2011. It also amends and reallocates over the term of the Supply Agreement the quantities of recombinant human insulin that the Company has agreed to purchase and Organon has agreed to sell and deliver.
     The Company expects to file the Amendment as an exhibit to its Annual Report on Form 10-K for the period ended September 30, 2009, and intends to seek confidential treatment for certain terms and provisions of the Amendment. The foregoing description is qualified in its entirety by reference to the complete text of the Amendment when filed.
SAFE HARBOR FOR FORWARD-LOOKING STATEMENTS
     This Current Report on Form 8-K contains 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. All statements, other than statements of historical facts, including statements regarding our strategy, future operations, future clinical trial results, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The company’s forward-looking statements are subject to a number of known and unknown risks and uncertainties that could cause actual results, performance or achievements to differ materially from those described or implied in the forward-looking statements, including, but not limited to, our ability to have our VIAject® NDA accepted for filing by the FDA; our ability to secure FDA approval for VIAject® and our other product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; our ability to market, commercialize and achieve market acceptance for product candidates developed using our VIAdel™ technology, particularly VIAject®; the progress or success of our research, development and clinical programs and the initiation and completion of our clinical trials; the FDA’s findings regarding data anomalies observed in India in our Phase 3 clinical trial of VIAject® for patients with Type 1 diabetes; our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; our estimates of future performance; our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of those collaborations after consummation, if consummated; the rate and degree of market acceptance and clinical utility of our products; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding anticipated operating losses,

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future revenues, capital requirements and our needs for additional financing; and other factors identified in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2009. The company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this report.

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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.
         
Date: November 18, 2009  BIODEL INC.
 
 
  By:   /s/ Gerard J. Michel    
    Gerard J. Michel, Chief Financial Officer   
       
 

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