-----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, I+f4JBqND8nwu2TYnDObFiPpE3DMS3+ktiNc6TQIxATWKdnpBCg/v1gZFOet1i0t 5CY/XY8lS9b/6WVi1afSKA== 0001169232-09-003318.txt : 20090710 0001169232-09-003318.hdr.sgml : 20090710 20090710151811 ACCESSION NUMBER: 0001169232-09-003318 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20090710 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090710 DATE AS OF CHANGE: 20090710 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CARACO PHARMACEUTICAL LABORATORIES LTD CENTRAL INDEX KEY: 0000887708 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 382505723 STATE OF INCORPORATION: MI FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-31773 FILM NUMBER: 09940027 BUSINESS ADDRESS: STREET 1: 1150 ELIJAH MCCOY DR CITY: DETROIT STATE: MI ZIP: 48202 BUSINESS PHONE: 3138718400 MAIL ADDRESS: STREET 1: 1150 ELIJAH MCCOY DRIVE CITY: DETROIT STATE: MI ZIP: 48202 8-K 1 d77353_8-k.htm CURRENT REPORT

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

 

July 10, 2009

(Date of report)

 

CARACO PHARMACEUTICAL LABORATORIES, LTD.

(Exact name of registrant as specified in its charter)

 

 

Michigan

 

1-31773

 

38-2505723

(State or other jurisdiction of incorporation)

 

(Commission file number)

 

(I.R.S. employer identification no.)

 

 

1150 Elijah McCoy Drive, Detroit, Michigan 48202

(Address of principal executive offices)

 

(313) 871-8400

(Registrant’s telephone number, including area code)

 

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:

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 140.14a-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 7.01. Regulation FD Disclosure

 

On July 10, 2009, registrant issued a press release announcing that, as part of the settlement of the legal proceedings related to Lexapro® (escitalopram oxalate) tablets, it entered into an Asset Purchase Agreement with Forest Laboratories, Inc. (“Forest”) to acquire several products from Forest’s Inwood line of business. A copy of the press release, dated July 10, 2009, is furnished as Exhibit 99.1 to this report.

 

Item 9.01. Financial Statements and Exhibits

 

d)

Exhibits.

 

Exhibit No.

Description

 

99.1

Press Release of Caraco Pharmaceutical Laboratories, Ltd., dated July 10, 2009, and furnished with this report.

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, registrant has duly

caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

CARACO PHARMACEUTICAL LABORATORIES, LTD.

(Registrant)

 

Date:

July 10, 2009

By:

/s/ Daniel H. Movens   

Daniel H. Movens

Chief Executive Officer

 

33

2

 

 


Exhibit Index

 

Exhibit No.

Description

 

 

 

 

 

3

 

 

 

EX-99.1 2 d77353_ex99-1.htm PRESS RELEASE

Contacts:

 

Caraco Pharmaceutical - Daniel Movens- P: (313) 871-8400

Caraco Pharmaceutical – Thomas Versosky - P: (313) 556-4150

 

Caraco Pharmaceutical Laboratories, Ltd. Enters into Asset Purchase Agreement with Forest Laboratories, Inc. to Settle Lexapro® (escitalopram oxalate) ANDA Patent Litigation

DETROIT, July 10, 2009 -- Caraco Pharmaceutical Laboratories, Ltd. (NYSE Amex: CPD) announced that, as part of the settlement of the legal proceedings related to Lexapro® (escitalopram oxalate) tablets, it entered into an Asset Purchase Agreement with Forest Laboratories, Inc. (“Forest”) to acquire several products from Forest’s Inwood line of business. The ANDA patent litigation settlement resolves litigation involving Caraco, Forest, Forest Holdings, Ltd., and H. Lundbeck A/S and Sun Pharmaceutical Industries Limited (“Sun”). Caraco is a subsidiary of Sun.

Among other things, with respect to Caraco, the litigation settlement involves the following provisions:

1.     Forest has agreed to provide licenses to Caraco for any patents related to Lexapro® with respect to the marketing of Caraco’s generic version of the product as of the date that any third party generic enters the market with final approval from the FDA other than an authorized generic or the first filer with Hatch-Waxman related exclusivity.

2.         Forest will reimburse Caraco for a portion of its attorney’s fees related to this litigation.

3.         Pursuant to the Asset Purchase Agreement (the “APA”), Caraco will take over the commercialization and sale of several products from Forest’s Inwood business. Caraco will pay Forest an advance against royalties and royalties on net sales of these products.

The terms of the settlement will be submitted to the Federal Trade Commission and the Department of Justice pursuant to the Medicare Modernization Act. The APA is scheduled to close no sooner than 40 days after the signing, which the parties hope will provide the FTC and DOJ with sufficient time to review the transaction. As the transaction must be submitted to the FTC and DOJ, there is a possibility that the transaction may need to either be revised, or it may not be consummated, and the litigation would be re-instituted.

Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers.

Safe Harbor: This news release contains forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such

 

4

 


statements are based on management's current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties are contained in the Corporation's filings with the Securities and Exchange Commission and include, but are not limited to: information of a preliminary nature that may be subject to adjustment, potentially not obtaining or delay in obtaining FDA approval for new products, governmental restrictions on the sale of certain products, development by competitors of new or superior products or less expensive products or new technology for the production of products, the entry into the market of new competitors, market and customer acceptance and demand for new pharmaceutical products, availability of raw materials, timing and success of product development and launches, dependence on a few products generating a majority of sales, product liability claims for which the Company may be inadequately insured, and other risks identified in this report and from time to time in our periodic reports and registration statements. These forward-looking statements represent our judgment as of the date of this report. We disclaim, however, any intent or obligation to update our forward-looking statements.

 

5

 

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