-----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, WMzZksmOuXeeVo7zVFit6wnhAxjWnbOlSzX4VEd99mU4CqmLSEwYyG4id7eHXOp7 XFZK6gOz7LdDJOawN+pwdw== 0000950116-05-003445.txt : 20051108 0000950116-05-003445.hdr.sgml : 20051108 20051108085734 ACCESSION NUMBER: 0000950116-05-003445 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20051107 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20051108 DATE AS OF CHANGE: 20051108 FILER: COMPANY DATA: COMPANY CONFORMED NAME: IMPAX LABORATORIES INC CENTRAL INDEX KEY: 0001003642 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 650403311 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-27354 FILM NUMBER: 051184831 BUSINESS ADDRESS: STREET 1: 30831 HAYWARD AVE CITY: HAYWARD STATE: CA ZIP: 94544 BUSINESS PHONE: 2152892220 MAIL ADDRESS: STREET 1: CASTOR & KENSINGTON AVENUES CITY: PHILADELPHIA STATE: PA ZIP: 19124-5694 FORMER COMPANY: FORMER CONFORMED NAME: GLOBAL PHARMACEUTICAL CORP \DE\ DATE OF NAME CHANGE: 19951117 8-K 1 eight-k.txt FORM 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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): November 7, 2005 IMPAX LABORATORIES, INC. ------------------------------------------------------ (Exact Name of Registrant as Specified in Its Charter) Delaware ---------------------------------------------- (State or Other Jurisdiction of Incorporation) 0-27354 65-0403311 ------------------------ ------------------------------------ (Commission File Number) (I.R.S. Employer Identification No.) 30831 Huntwood Ave., Hayward, CA 94544 (Address of Principal Executive Offices) (510) 476-2000 ---------------------------------------------------- (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 (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 7.01 REGULATION FD DISCLOSURE Impax Laboratories, Inc. (the "Company") announced on November 7, 2005 that it has entered into a ten-year Exclusive Supply and Distribution Agreement with DAVA Pharmaceuticals, Inc. ("DAVA") for the Company's 10mg, 20mg, 40mg and 80mg dosage strengths of Oxycodone Hydrochloride Extended Release Tablets. In exchange for payments of up to $60 million over the next 5 years and sharing of gross profits, DAVA will have exclusive sales and distribution rights in the United States and Puerto Rico. DAVA is providing financial guarantees to assure payment of a portion of the $60 million. The Company will be responsible for all manufacturing and regulatory aspects. The Company's press release announcing that it has entered into this agreement is attached as Exhibit 99.1 to this current report on Form 8-K. ITEM 8.01 OTHER EVENTS Also on November 7, 2005, the Company submitted to the Office of the Chief Accountant of the Securities and Exchange Commission (OCA) additional information sought by the OCA in connection with the Company's request for guidance concerning the appropriate periods in which to recognize revenues from 2004 sales of products under the Company's strategic alliance agreement with a subsidiary of Teva Pharmaceutical Industries, Ltd. The Company believes this information will enable the OCA to provide the requested guidance, which should facilitate the Company's filing of its delayed 2004 annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. While the timing of this submission will cause the Company to miss the deadline for obtaining Nasdaq relisting on an expedited basis, the Company expects that quotations for its common stock will continue to appear in the Pink Sheets and that the relisting process will be initiated as soon as its filings have become current. ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS (d) Exhibits Exhibit No. Description - ----------- ----------- 99.1 Press Release 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. IMPAX LABORATORIES, INC. Date: November 8, 2005 By: /s/ Arthur A. Koch ------------------------------- Arthur A. Koch Chief Financial Officer 3 EX-99.1 2 ex99-1.txt EXHIBIT 99.1 PRESS RELEASE (LOGO) IMPAX Laboratories, Inc. COMPANY CONTACTS: INVESTOR RELATIONS CONTACTS: IMPAX Laboratories, Inc. Lippert/Heilshorn & Associates, Inc. - ------------------------ ------------------------------------ Barry R. Edwards, CEO Kim Sutton Golodetz (kgolodetz@lhai.com) (215) 933-0360 (212) 838-3777 Larry Hsu, Ph.D. President Bruce Voss (bvoss@lhai.com) (510) 476-2000, Ext. 1111 (310) 691-7100 Arthur Koch, CFO www.lhai.com (215) 933 0351 www.impaxlabs.com IMPAX SIGNS EXCLUSIVE SUPPLY AND DISTRIBUTION AGREEMENT WITH DAVA PHARMACEUTICALS FOR OXYCODONE HYDROCHLORIDE EXTENDED RELEASE TABLETS HAYWARD, CALIFORNIA (NOVEMBER 7, 2005) - IMPAX LABORATORIES, INC. (OTC: IPXL) announced today it has entered into a ten year Exclusive Supply and Distribution agreement with DAVA Pharmaceuticals, Inc (DAVA). for IMPAX's 10mg, 20mg, 40mg and 80mg dosage strengths of Oxycodone Hydrochloride Extended Release Tablets. In exchange for payments of up to $60 million over the next 5 years and sharing of gross profits, DAVA will have exclusive sales and distribution rights in the United States and Puerto Rico. IMPAX will be responsible for all manufacturing and regulatory aspects. The combined branded and generic U.S. sales for the 10mg, 20mg, 40mg and 80mg strengths of Oxycodone Hydrochloride Extended Release Tablets were over $1.8 billion for the twelve-month period ended August 31, 2005 according to NDCHealth. "We are looking forward to working with DAVA on this important product," said Barry R. Edwards, Chief Executive Officer of IMPAX. "We believe the combination of economic terms and DAVA's strong sales and marketing organization, make this a very attractive business opportunity for IMPAX." IMPAX had been marketing the 80mg dosage strength through its Global Pharmaceutical Division; and will be transitioning sales and marketing responsibilities to DAVA. IMPAX currently has a tentative Abbreviated New Drug Application (ANDA) approval for the 10mg, 20mg and 40mg dosage strengths with final approval subject to the expiration of market exclusivity on December 5th, 2005. ABOUT DAVA PHARMACEUTICALS DAVA Pharmaceuticals, a specialty pharmaceutical company, is focused on product development and marketing a broad portfolio of pharmaceutical products. DAVA Pharmaceuticals is aggressively building its product portfolio through a combination of acquisitions, strategic alliances, in-licensing transactions, partnerships and development. For further information, please visit www.davapharma.com. ABOUT IMPAX LABORATORIES IMPAX Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. IMPAX markets its generic products through its Global Pharmaceuticals division and intends to market its branded products through the IMPAX Pharmaceuticals division. Additionally, where strategically appropriate, IMPAX has developed marketing partnerships to fully leverage its technology platform. IMPAX Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward and Philadelphia facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com. "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995: To the extent any statements made in this news release contain information that is not historical, these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause IMPAX's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, possible adverse effects resulting from the delisting of IMPAX's stock, IMPAX's delay in filing its 2004 Form 10-K and its Form 10-Q's for the first two quarters of 2005, IMPAX's ability to obtain sufficient capital to fund its operations, the difficulty of predicting FDA filings and approvals, consumer acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, IMPAX's ability to successfully develop and commercialize pharmaceutical products, IMPAX's reliance on key strategic alliances, the uncertainty of patent litigation, the availability of raw materials, the regulatory environment, dependence on patent and other protection for innovative products, exposure to product liability claims, fluctuations in operating results and other risks detailed from time to time in IMPAX's filings with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and IMPAX undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise. # # # -----END PRIVACY-ENHANCED MESSAGE-----