-----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, P0L8WSqzVVevhRVd6cF0xeD/HpAzowg3xyYJumpkN7fqyp5h54qg3pZaqyHipQyG kxjGlan5I9qcLYbHHMEL7g== 0001193125-08-253485.txt : 20081215 0001193125-08-253485.hdr.sgml : 20081215 20081215154555 ACCESSION NUMBER: 0001193125-08-253485 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20081212 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20081215 DATE AS OF CHANGE: 20081215 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CERUS CORP CENTRAL INDEX KEY: 0001020214 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 680262011 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21937 FILM NUMBER: 081249767 BUSINESS ADDRESS: STREET 1: 2411 STANWELL DR CITY: CONCORD STATE: CA ZIP: 94520 BUSINESS PHONE: 9252886000 MAIL ADDRESS: STREET 1: 2525 STANWELL DRIVE STREET 2: STE 300 CITY: CONCORD STATE: CA ZIP: 94520 FORMER COMPANY: FORMER CONFORMED NAME: CERUS TECHNOLOGIES INC DATE OF NAME CHANGE: 19960731 8-K 1 d8k.htm FORM 8-K Form 8-K

 

 

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): December 12, 2008

CERUS CORPORATION

(Exact name of registrant as specified in its charter)

 

Delaware   0-21937   68-0262011
(State of jurisdiction)   (Commission File No.)   (IRS Employer Identification No.)

2411 Stanwell Drive

Concord, California 94520

(Address of principal executive offices and zip code)

Registrant’s telephone number, including area code: (925) 288-6000

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):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ 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 December 12, 2008, Cerus Corporation (the “Company”) entered into an Amended and Restated Manufacturing and Supply Agreement (the “Agreement”) with Fenwal, Inc. (“Fenwal”) which amends and restates a Manufacturing and Supply Agreement, dated February 2, 2005, between the Company and certain affiliates of Baxter Inc. (“Baxter”). The obligations of the Baxter affiliates under the original agreement were assumed by Fenwal in 2007. Under the Agreement, Fenwal is obligated to sell and the Company is obligated to purchase finished disposable kits for the Company’s INTERCEPT Blood System for platelets (“Platelet Sets”) and the INTERCEPT Blood System for plasma (“Plasma Sets”) for both clinical and commercial use. The Agreement permits the Company to purchase Platelet Sets and Plasma Sets from third-party manufacturers provided that it meets certain annual minimum purchase obligations to Fenwal. Upon twenty-four months prior notice of termination by the Company, the Agreement obligates the Company to purchase and Fenwal to supply certain amounts of Platelet Sets and Plasma Sets over the subsequent twenty-four months following such notice. In the event the Company requires certain raw materials or components for manufacture of Platelet Sets or Plasma Sets by the Company or its contract manufacturers, Fenwal is obligated to supply such raw materials or components. Under the Agreement, the Company is responsible for the full management and control of the supply chain for the INTERCEPT Illuminator devices (the “Illuminators”) and certain other components of the Platelet Sets and Plasma Sets, including the resolution of technical issues with third party manufacturers supplying such Illuminators and other components. The Agreement revises the pricing of purchased products for both clinical and commercial use. Under the Agreement, the Company will purchase from Fenwal approximately 45 Illuminators in Fenwal’s existing inventory. Except for such sale, Fenwal will not supply further Illuminators to the Company, and the Company is free to purchase Illuminators directly from third party manufacturers.

The term of the Agreement extends through December 31, 2013 and is automatically renewed thereafter for one year terms, with such renewal periods subject to termination by either party upon thirty months prior written notice, in the case of Fenwal, or twenty-four months prior written notice, in the case of the Company. The Company and Fenwal each have normal and customary termination rights, including termination for material breach.

The Agreement also contains certain provisions regarding the rights and responsibilities of the parties with respect to manufacturing specifications, forecasting and ordering, delivery arrangements, payment terms, packaging requirements, change orders, confidentiality and indemnification, as well as certain other customary matters.

Item 9.01.   Financial Statements and Exhibits.

 

  (d) Exhibits

 

  99.1   Press Release, dated December 15, 2008, entitled “Cerus Corporation Extends Manufacturing Agreement with Fenwal.”

 

2


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.

 

    CERUS CORPORATION
Dated: December 15, 2008     By:   /s/ Howard G. Ervin
       

Howard G. Ervin

Vice President, Legal Affairs

 

3


EXHIBIT INDEX

 

Exhibit
Number

 

Description

99.1   Press Release, dated December 15, 2008, entitled “Cerus Corporation Extends Manufacturing Agreement with Fenwal.”

 

4

EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

Contact:

William J. Dawson

Vice President, Finance & CFO

Cerus Corporation

(925) 288-6053

Cerus Corporation Extends Manufacturing Agreement with Fenwal

New Five Year Agreement Assures Supply, Lowers Unit Costs

CONCORD, Calif.—(BUSINESS WIRE)—December 15, 2008— Cerus Corporation (NASDAQ:CERS) today announced an agreement to extend its manufacturing agreement with Fenwal, Inc. for INTERCEPT Blood System products. Under the new agreement, Fenwal will supply Cerus with finished disposable kits for the INTERCEPT platelet and plasma systems through the end of 2013.

“We are pleased to have extended our supply relationship with Fenwal,” said Claes Glassell, president and CEO of Cerus. “The new agreement is expected to assure our long-term supply of finished INTERCEPT platelet and plasma kits while reducing our unit costs. Together with other initiatives, we believe we are making good progress toward meeting our objective of extending our cash resources through the end of 2009.”

ABOUT FENWAL

Fenwal, Inc. of Lake Zurich, Illinois, is a global leader in blood technologies focused on improving blood collection, safety and availability for patient care. Fenwal develops leading products, services and technologies used to collect, process and store blood and its vital components. For more information, visit www.fenwalinc.com.

ABOUT CERUS

Cerus Corporation is a biomedical products company focused on commercializing the INTERCEPT Blood System to enhance blood safety. The INTERCEPT Blood System is designed to inactivate blood-borne pathogens in donated blood components intended for transfusion. Cerus currently markets the INTERCEPT Blood System for both platelets and plasma in Europe, Russia, the Middle East and selected countries in other regions around the world. The Company is also pursuing regulatory approvals in the United States and other countries. The INTERCEPT red blood cell system is currently in clinical development.


INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.

Forward Looking Statements

This press release contains forward-looking statements, including, without limitation, statements related to the adequacy of our long-term supply of disposable kits under the new agreement with Fenwal and our ability to extend our cash resources through the end of 2009. Words such as “expect” and “believe” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the company’s current expectations. Forward-looking statements involve risks and uncertainties. The company’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, Fenwal’s ability to meet their supply obligations under the agreement, our ability to market, sell and distribute our products, our ability to manage cash requirements associated with operating our business and our estimates regarding the sufficiency of our cash resources. These and other risk factors are discussed under “Risk Factors” in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2008. The company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

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