-----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, OkZh+S251iA8umtr+K/V/2PEjHPU4f1PGwKH2HQSzhZPwNpZmXqWpfSrr8XV0yqc y8T2Iy/9LYbiLNtUltp/MQ== 0001035704-08-000293.txt : 20080623 0001035704-08-000293.hdr.sgml : 20080623 20080623170751 ACCESSION NUMBER: 0001035704-08-000293 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20080620 ITEM INFORMATION: Termination of a Material Definitive Agreement ITEM INFORMATION: Triggering Events That Accelerate or Increase a Direct Financial Obligation under an Off-Balance Sheet Arrangement ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080623 DATE AS OF CHANGE: 20080623 FILER: COMPANY DATA: COMPANY CONFORMED NAME: REPLIDYNE INC CENTRAL INDEX KEY: 0001180145 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 841568247 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-52082 FILM NUMBER: 08912682 BUSINESS ADDRESS: STREET 1: 1450 INFINITE DRIVE CITY: LOUISVILLE STATE: CO ZIP: 80027 BUSINESS PHONE: 303-665-3450 MAIL ADDRESS: STREET 1: 1450 INFINITE DRIVE CITY: LOUISVILLE STATE: CO ZIP: 80027 8-K 1 d57920e8vk.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): June 23, 2008 (June 20, 2008)
REPLIDYNE, INC.
(Exact name of registrant as specified in its charter)
         
Delaware
(State or other jurisdiction of
incorporation or organization)
  000-52082
(Commission File Number)
  84-1568247
(I.R.S. Employer
Identification No.)
     
1450 Infinite Drive,    
Louisville, Colorado   80027
(Address of principal executive offices)   (Zip Code)
303-996-5500
(Registrant’s telephone number, including area code)
Not Applicable
(Former name, former address and former fiscal year, 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 Material Definitive Agreement.
     On June 20, 2008, Replidyne, Inc. (the “Company”) decided to terminate its license agreement with Asubio Pharma Co., Ltd. (the “License Agreement”). Pursuant to the License Agreement, the Company had an exclusive license to, with the right to sublicense, Asubio Pharma’s patent rights and know-how to develop and commercialize all forms of faropenem medoxomil (“faropenem”) for adult and pediatric use in the U.S. and Canada. The License Agreement also granted the Company with a sole negotiation right to develop and commercialize faropenem in the rest of the world, excluding Japan, until two years following the commercial introduction of faropenem in the U.S. or Canada. In conjunction with this decision, the Company also terminated its supply agreement with Asubio Pharma and Nippon Soda Co., Ltd. for production of faropenem (the “Supply Agreement”).
     The Company has decided to terminate these agreements as a result of the Company being unable to secure a partner for the faropenem program. As previously announced, Replidyne had discontinued clinical development of faropenem pending the outcome of discussions with potential partners for such program.
     As a result of these terminations, the Company expects to incur charges of up to ¥440 million (approximately $4.1 million), consisting of a fee of up to ¥375 million (approximately $3.5 million) to Asubio Pharma resulting from the termination of the License Agreement and the reimbursement of engineering costs under the Supply Agreement of up to ¥65 (approximately $0.6 million) to Nippon Soda. The Company will also pay Nippon Soda ¥99 million (approximately $0.9 million) for delay compensation related to the period from January 1, 2008 through the termination of the Supply Agreement.
Item 2.04   Triggering Events That Accelerate or Increase a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement.
     As described above, the Company expects to incur certain charges and expenses resulting from its termination of the License Agreement and the Supply Agreement. The information contained in Item 1.02 of this Current Report on Form 8-K is hereby incorporated by reference herein.
Item 7.01   Regulation FD Disclosure.
     On June 23, 2008, the Company issued a press release announcing the termination of the License Agreement and the Supply Agreement. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.
     The information presented under this Item 7.01 and attached as Exhibit 99.1 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.
Item 9.01   Financial Statements and Exhibits.
(d)   Exhibits.
         
Exhibit No.   Description
       
 
  99.1    
Press release of Replidyne, Inc. dated June 23, 2008 entitled “Replidyne Terminates Faropenem Agreements”.

 


 

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.
         
  REPLIDYNE, INC.
 
 
Dated: June 23, 2008  By:   /s/ Mark L. Smith    
    Mark L. Smith   
    Chief Financial Officer
Principal Accounting Officer 
 

 


 

         
EXHIBIT INDEX
         
Exhibit No.   Description
       
 
  99.1    
Press release of Replidyne, Inc. dated June 23, 2008 entitled “Replidyne Terminates Faropenem Agreements”.

 

EX-99.1 2 d57920exv99w1.htm PRESS RELEASE exv99w1
EXHIBIT 99.1
(REPLIDYNE LOGO)
Replidyne contact:
Mark Smith
Chief Financial Officer
T: (303) 996-5535
Replidyne Terminates Faropenem Agreements
Louisville, CO, June 23, 2008 — Replidyne, Inc. (Nasdaq: RDYN) today announced that it has decided to terminate its license agreement with Asubio Pharma Co., Ltd. for faropenem medoxomil (faropenem). In conjunction with this decision, the Company also announced that it has terminated its supply agreement with Asubio Pharma Co., Ltd. and Nippon Soda Co., Ltd. for production of faropenem. These decisions were made as a result of the Company being unable to secure a partner for the faropenem program. As previously announced, Replidyne had discontinued clinical development of faropenem pending the outcome of discussions with potential partners for the program.
As a result of today’s decision, the Company expects to incur charges of up to ¥440 million (approximately $4.1 million), consisting of a license termination fee of up to ¥375 million (approximately $3.5 million) to Asubio Pharma Co,. Ltd. and the reimbursement of engineering costs under its supply agreement of up to ¥65 (approximately $0.6 million) to Nippon Soda Co,. Ltd. Replidyne will also pay Nippon Soda Co,. Ltd. ¥99 million (approximately $0.9 million) for delay compensation related to the period from January 1, 2008 through the termination of its supply agreement.
“We are clearly disappointed that we have been unable to identify a partner for the faropenem program,” stated Kenneth J. Collins, President and Chief Executive Officer of Replidyne. “We have decided to terminate this program in order to preserve cash and focus our attention on our previously discussed strategic initiatives and our C. difficile Infection (CDI) program and novel anti-infective programs based on DNA replication inhibition technology.”
At May 31, 2008 Replidyne had cash and short term investments totaling $71.5 million.

 


 

About Replidyne, Inc.
Replidyne is a biopharmaceutical company focused on discovering, developing, in-licensing and commercializing innovative anti-infective products. Replidyne’s lead program is an investigational antibacterial agent REP3123 that targets Gram-positive Clostridium difficile (C. difficile) bacteria and C. difficile Infection (CDI). Replidyne is pursuing the development of other novel anti-infective programs based on its DNA replication inhibition technology and its in-house discovery research.
Safe Harbor
This press release contains plans, intentions, objectives, estimates and expectations that constitute forward-looking statements about Replidyne, Inc. that involve significant risks and uncertainties. Actual results could differ materially from those discussed due to a number of factors including, the success and timing of pre-clinical studies and clinical trials; the Company’s ability to obtain and maintain regulatory approval of product candidates and the labeling under any approval that may be obtained; plans to develop and commercialize product candidates; the loss of key scientific or management personnel; the size and growth of the potential markets for the Company’s product candidates and the Company’s 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 Company estimates regarding expenses, future revenues and capital requirements; the Company’s ability to obtain and maintain intellectual property protection for our product candidates; the successful development of the Company’s sales and marketing capabilities; the success of competing drugs that are or become available; and the performance of third party manufacturers. These and additional risks and uncertainties are described more fully in the Company’s most recent Form 10-K filed with the SEC under the Securities Exchange Act of 1934. Copies of filings made with the SEC are available through the SEC’s electronic data gathering analysis and retrieval system (EDGAR) at www.sec.gov. All forward-looking statements made in the press release are made as of the date hereof and the Company assumes no obligation to update the forward-looking statements in the document.
- ENDS

 

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