-----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, F8t4vg2lW6+3xWVVB+RGqJXFVEAuNsCGgX1K6OqvsBW6SbGkB0uoWd/M3Zuz1DRZ gwkufHxhGwK/MHfz60fr3A== 0001104659-06-047834.txt : 20060720 0001104659-06-047834.hdr.sgml : 20060720 20060720070116 ACCESSION NUMBER: 0001104659-06-047834 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20060720 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060720 DATE AS OF CHANGE: 20060720 FILER: COMPANY DATA: COMPANY CONFORMED NAME: IMCLONE SYSTEMS INC CENTRAL INDEX KEY: 0000765258 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 042834797 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-19612 FILM NUMBER: 06970422 BUSINESS ADDRESS: STREET 1: 180 VARICK STREET - 6TH FLOOR CITY: NEW YORK STATE: NY ZIP: 10014 BUSINESS PHONE: 646-638-5078 MAIL ADDRESS: STREET 1: 180 VARICK STREET - 6TH FLOOR CITY: NEW YORK STATE: NY ZIP: 10014 FORMER COMPANY: FORMER CONFORMED NAME: IMCLONE SYSTEMS INC/DE DATE OF NAME CHANGE: 19940211 8-K 1 a06-16422_28k.htm CURRENT REPORT OF MATERIAL EVENTS OR CORPORATE CHANGES

 

 

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): July 20, 2006

 

IMCLONE SYSTEMS INCORPORATED

(Exact name of registrant as specified in its charter)

 

Delaware

 

0-19612

 

04-2834797

(State or other jurisdiction of

 

(Commission File Number)

 

(IRS Employer Identification No.)

Incorporation)

 

 

 

 

 

180 Varick Street

New York, New York 10014

(Address of principal executive offices) (Zip Code)

 

(212) 645-1405

(Registrant’s telephone number, including area code)

 

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 (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 1.01  Other Events

ImClone Systems Incorporated (the “Company”) issued a press release today announcing that it and Merck KGaA have entered into agreements amending and supplementing the Development and License Agreement, dated December 14, 1998, as amended, between the parties.  A copy of the press release is attached as Exhibit 99.1 to this report.

ITEM 9.01.  Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

 

Description

 

 

 

 

 

99.1

 

Press Release of ImClone Systems Incorporated dated July 20, 2006.

 

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 hereunto duly authorized.

IMCLONE SYSTEMS INCORPORATED
(Registrant)

 

 

 

 

Dated: July 20, 2006

By:

/s/ Erik D. Ramanathan

 

 

Erik D. Ramanathan

 

 

Senior Vice President, Secretary and General Counsel

 

 

3




EXHIBIT INDEX

Exhibit No.

 

Description

99.1

 

Press Release of ImClone Systems Incorporated dated July 20, 2006.

 

4



EX-99.1 2 a06-16422_2ex99d1.htm EX-99

Exhibit 99.1

ImClone Systems Incorporated

 

 

Investors:

 

Media:

Andrea F. Rabney

 

David M. F. Pitts

(646) 638-5058

 

(646) 638-5058

Stefania Bethlen

 

 

(646) 638-5058

 

 

 

IMCLONE SYSTEMS AND MERCK KGaA AMEND AND SUPPLEMENT
ERBITUX AGREEMENT

New York, NY — July 20, 2006 — ImClone Systems Incorporated (NASDAQ: IMCL) and Merck KGaA, Darmstadt, Germany, announced today that they have entered into agreements amending and supplementing the 1998 development and license agreement covering ERBITUX® and certain other work in the field of EGFR-targeted antibodies.

As part of the agreements, ImClone Systems consented to Merck’s sublicense of certain intellectual property rights relating to the development and commercialization of an anti-EGFR antibody to Takeda Pharmaceutical Company. Merck and Takeda signed an alliance in September 2005 for the development and commercialization of matuzumab (EMD72000), a humanized EGFR-targeting monoclonal antibody.

In consideration for ImClone Systems’ consent, Merck agreed to pay ImClone Systems EUR 2.5 million upon execution of the agreements and a further EUR 5 million upon ImClone Systems’ written consent to the sublicense. In addition, Merck agreed to increase its fixed royalty to 9.5% for all sales of ERBITUX outside the U.S. and Canada, effective July 1, 2006.

The agreements also promote freedom to operate in the development and commercialization of matuzumab outside the United States and Canada and of IMC-11F8 (a fully human EGFR-targeted IgG1 monoclonal antibody being developed by ImClone Systems) within the United States and Canada through the granting of certain reciprocal rights, including the sharing of confidential technical information.

The agreements do not extend to key intellectual property rights in the U.S. and Canada, where ImClone Systems and its partner Bristol-Myers Squibb continue to hold exclusive licenses to key patents covering certain uses of EGFR-targeted monoclonal antibodies.

“We are pleased to have signed these agreements with Merck and believe that they will further strengthen our partnership,” said Joseph L. Fischer, Interim Chief Executive Officer of ImClone Systems. “The terms of these agreements benefit both partners as we continue to pursue advances in the development of novel oncology therapies.”




About ImClone Systems Incorporated

ImClone Systems Incorporated is committed to advancing oncology care by developing and commercializing a portfolio of targeted biologic treatments designed to address the medical needs of patients with a variety of cancers.  The Company’s research and development programs include growth factor blockers and angiogenesis inhibitors.  ImClone Systems’ strategy is to become a fully integrated biopharmaceutical company, taking its development programs from the research stage to the market.  ImClone Systems’ headquarters and research operations are located in New York City, with additional administration and manufacturing facilities in Branchburg, New Jersey.

Certain matters discussed in this news release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, it can give no assurance that its expectations will be achieved. Forward-looking information is subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Many of these factors are beyond the company’s ability to control or predict. Important factors that may cause actual results to differ materially and could impact the company and the statements contained in this news release can be found in the company’s filings with the Securities and Exchange Commission, including quarterly reports on Form 10-Q, current reports on Form 8-K and annual reports on Form 10-K. For forward-looking statements in this news release, the company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The company assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events or otherwise.

# # #



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-----END PRIVACY-ENHANCED MESSAGE-----