-----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, R2D2o3cqUi8MvPUoTsaQxPCvdB3afv5M5UV0UCPanu+sLLCFCOIoldVqYPgnWXux K5Oxzy2x3LNVfZXh0GyvJA== 0001104659-10-014639.txt : 20100316 0001104659-10-014639.hdr.sgml : 20100316 20100316172021 ACCESSION NUMBER: 0001104659-10-014639 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20100310 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Other Events FILED AS OF DATE: 20100316 DATE AS OF CHANGE: 20100316 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CEPHALON INC CENTRAL INDEX KEY: 0000873364 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 232484489 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-19119 FILM NUMBER: 10686508 BUSINESS ADDRESS: STREET 1: 41 MOORES ROAD CITY: FRAZER STATE: PA ZIP: 19355 BUSINESS PHONE: 6103440200 MAIL ADDRESS: STREET 1: 41 MOORES ROAD CITY: FRAZER STATE: PA ZIP: 19355 8-K 1 a10-6429_18k.htm 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)  March 10, 2010

 

Cephalon, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware

 

0-19119

 

23-2484489

(State or Other Jurisdiction

 

(Commission

 

(IRS Employer

of Incorporation)

 

File Number)

 

Identification No.)

 

41 Moores Road

 

 

Frazer, Pennsylvania

 

19355

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code  (610) 344-0200

 

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:

 

¨            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.

 

As previously disclosed, on February 23, 2010, Cephalon, Inc. (the “Company”) announced that, pursuant to the terms of an Option Agreement dated as of January 13, 2009 between the Company and Ception Therapeutics, Inc. (“Ception”) (as amended, the “Option Agreement”), it had exercised its option to acquire Ception following receipt of positive data from a Phase II clinical study on Ception’s lead compound, CINQUIL™ (reslizumab), in adults with eosinophilic asthma.

 

As contemplated by the Option Agreement, on March 10, 2010, the Company, Capture Acquisition Corp., a wholly owned subsidiary of the Company (“Merger Sub”), Ception and certain representatives of Ception’s stockholders entered into a Merger Agreement (the “Merger Agreement”) pursuant to which Merger Sub will be merged with and into Ception (the “Merger”), with Ception continuing as the surviving corporation and a wholly owned subsidiary of the Company.  Pursuant to the Merger Agreement, the Company has agreed to pay a total of $250 million to the holders of all the outstanding capital stock of Ception on a fully-diluted basis (the “Ception Stockholders”), subject to adjustment for any third party debt of Ception.

 

In addition, the Merger Agreement provides that Ception Stockholders could receive additional payments relating to achievement of certain clinical and regulatory milestones and royalties related to sales of certain products developed using Ception’s technology.

 

The Merger Agreement and the Merger have been approved by the requisite vote of stockholders of Ception. Consummation of the Merger is subject to customary conditions, including the absence of any governmental action, suit, investigation or proceeding prohibiting the closing, and the expiration of any applicable antitrust waiting periods.

 

Item 8.01               Other Events.

 

                On March 16, 2010, Cephalon, Inc. (“Cephalon”) filed a lawsuit in U.S. District Court in Delaware against Lupin Limited and Lupin Pharmaceuticals, Inc. (collectively, “Lupin”) for infringement of U.S. Patent Nos. 7,132,570 and RE37,516 for the Cephalon product NUVIGIL® (armodafinil) Tablets [C-IV].  The lawsuit is based upon an Abbreviated New Drug Application (“ANDA”) filed by Lupin seeking approval from the U.S. Food and Drug Administration (“FDA”) for a generic equivalent of armodafinil to be sold in the United States.  Lupin alleges that the above NUVIGIL patents are invalid, unenforceable and/or will not be infringed by Lupin’s manufacture, use or sale of the product described in its ANDA.

 

The filing of this lawsuit is provided for by the Hatch-Waxman Act, a federal statute governing certain aspects of generic drug approvals.  Under that statute, the filing of the lawsuit stays any FDA approval of the Lupin ANDA until the earlier of entry of a district court judgment in favor of Lupin or 30 months from Cephalon’s February 2010 receipt of a Paragraph IV certification letter from Lupin.

 

 

 

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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.

 

 

 

 

CEPHALON, INC.

 

 

 

 

 

 

Date: March 16, 2010

By:

/s/ Gerald J. Pappert

 

 

Gerald J. Pappert

 

 

Executive Vice President, General Counsel and Secretary

 

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