-----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, FAmC6GS1N751kt1yalh99eUnlowXWKK3r3VgPmoMFWDc8cgQ8WkuS/DfiHOaNszp NejDt6zrmM2rT3eYA3jHCw== 0000719598-95-000009.txt : 19951002 0000719598-95-000009.hdr.sgml : 19951002 ACCESSION NUMBER: 0000719598-95-000009 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19950907 ITEM INFORMATION: Changes in control of registrant FILED AS OF DATE: 19950928 SROS: NYSE FILER: COMPANY DATA: COMPANY CONFORMED NAME: MOLECULAR BIOSYSTEMS INC CENTRAL INDEX KEY: 0000719598 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 363078632 STATE OF INCORPORATION: DE FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-12648 FILM NUMBER: 95576634 BUSINESS ADDRESS: STREET 1: 10030 BARNES CANYON RD CITY: SAN DIEGO STATE: CA ZIP: 92121-2789 BUSINESS PHONE: 6194520681 MAIL ADDRESS: STREET 1: 10030 BARNES CANYON ROAD CITY: SAN DIEGO STATE: CA ZIP: 92121 8-K 1 Page 1 of 9 pages Exhibit Index at page 5 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): September 7, 1995 MOLECULAR BIOSYSTEMS, INC. (Exact name of registrant as specified in its charter) Delaware 1-10546 36-30878632 (State or other juris- Commission file (IRS employer diction of incorporation) number) identification number) 10030 Barnes Canyon Road, San Diego, California 92121 (Address of principal executive offices) Registrant's telephone number, including area code: (619) 452-0681 Item 5. Other Events. On September 7, 1995, Molecular Biosystems, Inc. (the "Company") entered into an amended and restated distribution agreement and a related investment agreement with Mallinckrodt Medical, Inc. ("Mallinckrodt") Amended and Restated Distribution Agreement The amended and restated distribution agreement (the "amended distribution agreement") modifies the December 1988 distribution agreement between the Company and Mallinckrodt in a number of respects. Under the amended distribution agreement, the geographical scope of Mallinckrodt's exclusive right to market the Company's proprietary contrast agent for transpulmonary cardiac ultrasound imaging, ALBUNEX (R), the Company's second generation ultrasound contrast agent, FS069 (which is currently under development), and related products was expanded to include all of the countries of the world other than those covered by the Company's license agreements with Shionogi & Co., Ltd. and Nycomed AS. The duration of Mallinckrodt's exclusive right was also extended from October 1999 until the later of July 1, 2003 or three years after the date that Company obtains approval from the U.S. Food and Drug Administration ("FDA") to market FS069 for an intravenous myocardial perfusion indication (use). Under the amended distribution agreement, Mallinckrodt will pay MBI $20 million over four years to support clinical trials of FS069, related regulatory submissions and associated product development. These payments will be made in 16 quarterly installments ranging from $1 million to $1.5 million beginning after the amended distribution agreement becomes effective (see the section, "Effective Dates"). The amended distribution agreement requires the Company to spend at least $10 million of this $20 million on clinical trials to support regulatory filings with the FDA for cardiac indications of FS069. The Company's expenditure of this $10 million will be made in accordance with the directions of a joint steering committee which the Company and Mallinckrodt will establish in order to expedite the development and regulatory approval of FS069 by enabling the parties to share their expertise relating to clinical trials and the regulatory approval process. The Company and Mallinckrodt will each appoint two of the four members of the joint steering committee. After the Company has spent this $10 million, the amended distribution agreement requires the Company and Mallinckrodt to share equally in the cost of any additional clinical trials of FS069 in the United States which the joint steering committee may direct to be performed, up to a maximum of $5 million on a combined basis. The amended distribution agreement also provides for potential payments to the Company of up to $12 million upon the satisfaction of certain milestones. (There can be no assurance, however, that all or any of these milestones will be satisfied.) In addition, the amended distribution agreement grants the Company the option to repurchase all of the shares of the Company's common stock that Mallinckrodt will purchase under the investment agreement (see the following section, "Investment Agreement") for $45 million, subject to various price adjustments. This option is exercisable after the later of July 1, 2000 or three years after the date that Company obtains approval from the FDA to market FS069 for an intravenous myocardial perfusion indication. If the Company exercises this option, the Company may co-market ALBUNEX (R), FS069 and related products in all of the countries covered by the amended distribution agreement. Investment Agreement Under the investment agreement, the Company will sell 1,118,671 unregistered shares of its common stock to Mallinckrodt for $13,000,000, or a price of $11.62 per share. These shares will be subject to certain anti-dilution and registration rights of Mallinckrodt and certain first refusal and "standstill" rights of MBI. With the 181,818 shares of the Company's common stock that Mallinckrodt acquired in December 1988 (under an investment agreement which the Company and Mallinckrodt entered into at the same time as they entered into the original distribution agreement), Mallinckrodt will own approximately 9.8% of the Company's outstanding stock. Effective Dates Both the amended distribution agreement and the investment agreement will become effective if and when all applicable waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 have expired or have otherwise terminated. Press Release A copy of the press release that the Company and Mallinckrodt jointly issued on September 7, 1995 to announce the two agreements is attached to this Report as Exhibit 10.1. 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. Date: September 25, 1995. MOLECULAR BIOSYSTEMS, INC. By /s/Steven Lawson Steven Lawson Vice President, Legal Affairs and General Counsel Exhibit Index Sequentially Numbered Exhibit Description Page 10.1 Press release (September 7, 1995) 6 EX-10 2 Exhibit 10.1 NEWS RELEASE FOR IMMEDIATE RELEASE For more information: Molecular Biosystems Gerard A. Wills, Chief Financial Officer Stephen A. Keane, Director, Investor Relations (619) 452-0681, ext. 2212 Mallinckrodt Group Barbara Abbett, Vice President, Communications, (314) 854-5230 Cole Lannum, Director, Investor Relations, (314) 854-5370 Bea Miller, Director, Communications, Mallinckrodt Medical, (314) 895- 7337 MOLECULAR BIOSYSTEMS, MALLINCKRODT GROUP ANNOUNCE NEW ALLIANCE SAN DIEGO, California and ST. LOUIS, Missouri, September 7,1995 -- Molecular Biosystems, Inc. (NYSE:MB) and Mallinckrodt Group Inc. (NYSE:MKG) today announced that they have entered into a new distribution and investment agreement for ALBUNEX (R), the first commercially available contrast agent for ultrasound imaging, and FS069, a major new ultrasound contrast product in development. The new agreement provides for Mallinckrodt to make an additional equity investment in MBI, fund FS069 clinical development and make various milestone payments. Under the terms of the agreement, Mallinckrodt will purchase $13 million of MBI common stock at $11.62 a share, giving Mallinckrodt a 10 percent ownership stake in MBI. Mallinckrodt also will pay MBI an additional $20 million over four years to support FS069 clinical trials and associated product development. MBI also may receive up to an additional $14.5 million for further clinical funding and milestone achievements. The total potential payment under the agreement will be $47.5 million. The new agreement extends and expands a 1988 alliance which provides for cooperative development and marketing of contrast agents designed to materially improve the clinical utility of ultrasound imaging, a non-invasive, non-radioactive, cost-effective diagnostic imaging modality. The distribution agreement extends Mallinckrodt Medical, Inc.'s sales and marketing exclusivity on these products from October 1999 until the latter of July 2003 or three years after FDA approves FS069 to visualize blood perfusing the heart muscle. It also expands Mallinckrodt Medical's exclusive rights to all countries of the world not already covered by MBI's existing agreements with Shionogi & Co., Ltd. and Nycomed AS. A key feature of the new arrangement is a collaborative effort to expedite clinical development of FS069. The agreement also permits MBI to reacquire coexclusive rights to products covered in the agreement after the year 2000. According to Kenneth J. Widder, M.D., MBI's chairman and chief executive officer, the financing associated with the agreements, cash resources currently on hand and the anticipated revenue from ALBUNEX (R) sales will substantially enhance MBI's financial position and move the company well toward FS069 commercialization. Widder added, "The new agreements demonstrate our companies' confidence in the significant market potential of ultrasound contrast. With FS069, we hope to take the field of ultrasound contrast imaging to a much higher degree of clinical utility than we envisioned when we entered the field in 1987." Robert G. Moussa, Mallinckrodt Medical president and chief executive officer, said, "Our additional investment in MBI is a clear indication of our belief that future generation ultrasound imaging agents will allow us to maintain our leadership and pioneering position in the ultrasound contrast market that we are gaining with ALBUNEX (R). We expect to establish FS069 as the leader for contrast-enhanced ultrasound imaging in cardiology and radiology applications." In May, MBI announced that it successfully completed FS069 Phase I trials in the United States. No significant adverse effects were noted in the Phase I results, even at relatively high dosage levels. More importantly, intravenously administered doses starting at 0.5 cc resulted in visually apparent and significant myocardial brightening (myocardial perfusion). Phase II trials for FS069 are expected to begin within the next several months. The agreement will become effective upon approval following review of the transaction by the Federal Trade Commission (FTC) under the Hart-Scott-Rodino Act. The parties are confident that the transaction does not raise any antitrust issues and that it will be approved by the FTC. Mallinckrodt Group, headquartered in St. Louis, provides specialty chemical and human and animal health products through its three international, technology-based operating companies: Mallinckrodt Chemical and Mallinckrodt medical, also headquartered in the St. Louis area, and Mallinckrodt Veterinary, headquartered in the Chicago, Illinois area. The company had fiscal 1995 sales of $2.2 billion. Molecular Biosystems, Inc., based in San Diego, California, is a leader in the development of ultrasound contrast agents for medical imagining. In August 1994, MBI received final approval form the U.S. Food and Drug Administration to begin domestic marketing of ALBUNEX (R), MBI's flagship ultrasound contrast agent. ALBUNEX (R) currently is marketed in Japan by Shionogi & Co., Ltd., and in the United States by Mallinckrodt Medical, Inc., an operating company of Mallinckrodt Group Inc. Hafslund Nycomed AS (NYSE:HN) will market ALBUNEX (R) in Europe. MBI shares are listed on the New York Stock Exchange under the symbol "MB." -----END PRIVACY-ENHANCED MESSAGE-----