-----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, Djx7dSco1iCJayavsRZ80MaFOLFNGhCa9T8+tAwHQlHLWNx423y3/Rc8fZTegRXx eFfshZ8jWcmDQE6IXWxDog== 0000950137-08-004068.txt : 20080321 0000950137-08-004068.hdr.sgml : 20080321 20080321155028 ACCESSION NUMBER: 0000950137-08-004068 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080318 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080321 DATE AS OF CHANGE: 20080321 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CytoCore Inc CENTRAL INDEX KEY: 0000075439 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 364296006 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-00935 FILM NUMBER: 08705228 BUSINESS ADDRESS: STREET 1: 414 NORTH ORLEANS STREET STREET 2: SUITE 502 CITY: CHICAGO STATE: IL ZIP: 60610 BUSINESS PHONE: 4078490290 MAIL ADDRESS: STREET 1: 414 NORTH ORLEANS STREET STREET 2: SUITE 502 CITY: CHICAGO STATE: IL ZIP: 60610 FORMER COMPANY: FORMER CONFORMED NAME: MOLECULAR DIAGNOSTICS INC DATE OF NAME CHANGE: 20011009 FORMER COMPANY: FORMER CONFORMED NAME: AMPERSAND MEDICAL CORP DATE OF NAME CHANGE: 19990527 FORMER COMPANY: FORMER CONFORMED NAME: BELL NATIONAL CORP DATE OF NAME CHANGE: 19920703 8-K 1 c25126e8vk.htm CURRENT REPORT 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) March 18, 2008
CytoCore, Inc.
 
(Exact name of registrant as specified in charter)
         
Delaware   0-935   36-4296006
 
(State or other jurisdiction   (Commission   (IRS Employer
of incorporation)   File Number)   Identification No.)
     
414 North Orleans Street, Suite 502, Chicago, Illinois   60610
 
(Address of principal executive offices)   (Zip Code)
Registrant’s telephone number, including area code (312) 222-9550
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
     On March 18, 2008, CytoCore, Inc. executed a Distribution Agreement with CoMedical, Inc., a sales and distribution company for healthcare products headquartered in Seattle, Washington (“CoMedical”). Pursuant to the agreement, CoMedical will act as the exclusive distributor in the states of Alaska, Washington, Idaho, Montana and Oregon of CytoCore’s SoftPap™ cervical cell collection device designed to screen for cervical cancer.
     The agreement provides for certain annual minimum purchase requirements for the products, ranging from 196,000 units in the first 12-month period to 2.3 million units in the third 12-month period. Prices are established for the products for 2008 and may be adjusted after December 31, 2008 to reflect changes in material and labor costs and to respond to changing market conditions. Such price changes may not occur more than twice per year. Procedures for the return of products and product recalls are as set forth in the agreement. Requirements as to insurance coverage to be maintained by CoMedical at its own expense are also specified.
     CoMedical must use its best efforts to create and maintain a market for, and increase the sales of, the products in its designated territory and provide at its own expense an organization for the continuous sale, promotion and distribution thereof, including its own sales force. CytoCore will provide initial product training and marketing materials, and may from time to time provide additional advertising, promotional and instructional materials. Any advertisements and the media in which they are to be used, as well as promotional and instructional materials, must be approved in advance by CytoCore.
     The agreement’s initial term is three years, and automatically renews for further one-year periods unless notice of termination is received by a party at least 90 days prior to the expiration of the initial term. CytoCore also has the right to terminate the agreement at any time prior to the expiration of its term in the event CoMedical fails to attain the annual minimum purchase requirements or in the event the continued performance of the agreement becomes impractical due to the enactment or threatened enactment of any ordinance, statute, regulation, law or similar provision. The agreement also provides for termination by CytoCore in the event of “cause”, as such term is defined in the agreement, including but not limited to the consistent failure by CoMedical to achieve minimum annual sales volumes or maintain and properly train a sales and service staff of adequate size for meeting such requirements, the transfer by CoMedical of more than 10% of its assets other than in the ordinary course of business or 10% of its capital stock, an attempted sale, transfer or assignment of the agreement without CytoCore’s prior consent, or the bankruptcy or insolvency of the distributor.
     Under the agreement, neither CoMedical nor its affiliates or subsidiaries may sell, promote or otherwise distribute any products that compete directly with the Company’s products, and the distributor may not establish any branch, or maintain any distribution depot, outside of its territory for the sale of the products. The distributor is also bound by confidentiality obligations and acknowledges the rights and ownership, intellectual property and otherwise, of CytoCore in and to the products. CytoCore and CoMedical further agreed to a non-solicitation covenant with respect to any employees or agents, which covenant shall be in force during the term of the agreement and for a two-year period thereafter.

 


 

     A copy of the press release announcing the agreement with CoMedical is attached hereto as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits.
99.1 Press release dated March 17, 2008

 


 

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.
         
  CytoCore, Inc.
 
 
Dated: March 21, 2008  By:   /s/ Robert F. McCullough Jr.    
    Robert F. McCullough Jr.   
    Chief Executive Officer, Chief Financial
Officer and Director 
 
 

 

EX-99.1 2 c25126exv99w1.htm PRESS RELEASE exv99w1
 

Exhibit 99.1
CytoCore Signs First U.S. Distributor for SoftPAP(TM) Cell Collectors
Monday March 17, 6:32 am ET
Company Ships First U.S. Order
CHICAGO—(BUSINESS WIRE)—CytoCore Inc. (OTCBB:CYOE — News), a leading developer of cost-effective cancer screening systems to assist in the early detection of cervical, endometrial, and other cancers, announced today its first U.S. distribution agreement and first U.S. order for its SoftPAP™ cell collector, the revolutionary sample collection device, with CoMedical, Inc., headquartered in Seattle, Washington (www.comedical.com).
 
Privately held CoMedical, Inc. was founded in 1980 and serves healthcare professionals in Washington, Oregon, Idaho, Montana, Wyoming and Alaska. The Company focuses on representing small innovative healthcare product manufacturers to introduce their products to targeted healthcare professionals.
The SoftPAP Cervical Cell Collector offers a quicker, more accurate specimen collection for the Pap test with minimal possibility of user error.  SoftPAP is designed to collect a full 360 degree specimen from both the cervical canal and the outer surface of the cervix, simultaneously resulting in a more complete and comprehensive specimen for testing.  It is designed to consistently sample the entire cervix in a single-step using an inflatable balloon collector. The patented single-use silicon balloon is a mirror image of the surface of the ecto- and endo-cervix. During collection, the balloon is slightly inflated by pressing a button on the collector handle. The volume of air is fixed and controlled so no over or under inflation can occur. The balloon is designed so that regardless of the shape of the cervix, when the balloon inflates, the balloon’s surface comes into contact with all walls of the cervix that need sampling in a single step. Cells are collected from 360 degrees around the ecto-cervix, and from within the endo-cervix by touch. No rotation of the Collector is necessary.  Results include greater patient comfort and ease of use for the physician, and greater cellularity thereby reducing the inadequate specimens for analysis. When compared to traditional cell collection techniques, clinical studies have shown that while collecting a better quality specimen, SoftPAP reduces patient adverse events, primarily bleeding and spotting, by 95%.  By virtually eliminating “adverse events,” the SoftPAP should help overcome any patient reluctance to having the Pap test, which, in turn, should provide a method to increase early detection of HPV and potentially related cervical dysplasia.
“The SoftPAP cervical cell collector is a major advancement for the Pap test,” said Robert McCullough, Jr., President & CEO of CytoCore. “The Collector offers much greater patient comfort as well as improved physician confidence in the test sample by acquiring a more complete and comprehensive cervical specimen for more consistently reliable Pap test results. As with the launch of any new medical device, it is critical to work with the right partners who have proven abilities to develop market opportunities.  CoMedical is such a partner. Their focus on the Pacific Northwest and their emphasis on working with innovative manufacturers such as CytoCore are both characteristics that enhance our team’s potential for success with the Collector’s introduction in this country.  We expect this agreement to be the first of a number of regional distribution agreements we will sign in the near future as CytoCore expands its production and marketing plans in the U.S.,” Mr. McCullough added.
About CytoCore Inc.
CytoCore develops cost-effective cancer screening systems, which can be utilized in a laboratory or at the point-of-care, to assist in the early detection of cervical, endometrial, and other cancers. The CytoCore Solutions(tm) System is being developed to provide medical practitioners with highly accurate, low-cost, cervical and uterine cancer screening systems that can be seamlessly integrated into existing medical models. More information is available at: www.CytoCoreInc.com.
Certain statements in this release are forward-looking. These statements are based on CytoCore’s current expectations and involve many risks and uncertainties, such as the company’s inability to obtain sufficient financing, the possibility that clinical trials will not substantiate CytoCore’s expectations with respect to the CytoCore Solutions™ System, and other factors set forth in reports and documents filed by CytoCore with the Securities and Exchange Commission. Actual results may differ materially from CytoCore’s current expectation depending upon a number of factors affecting the Company’s business. These factors include, among others, risks and uncertainties detailed in the Company’s periodic public filings with the Securities and Exchange Commission, including but not limited to the Company’s Annual Report on Form 10-K for the year ended December 31, 2006. Except as expressly required by law, CytoCore undertakes no obligation to publicly update or revise any forward-looking statements contained herein.
Contact:
CytoCore, Inc.
Robert McCullough, Jr., 312-222-9550
or
EVC Group
Douglas Sherk/Matthew Selinger, 415-896-6820
mselinger@evcgroup.com

 

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