-----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, D+Y02CJuN+ilTTgAYMB+LBcrQsZ0J6Wq/HY/oKiV07uZ9hjHjQVIMltiZ4lBgqyK Xjg2gdKBwp8OsJ+F/HOpGQ== 0000856984-02-000002.txt : 20020413 0000856984-02-000002.hdr.sgml : 20020413 ACCESSION NUMBER: 0000856984-02-000002 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20011126 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20020109 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AMERICAN BIOGENETIC SCIENCES INC CENTRAL INDEX KEY: 0000856984 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 112655906 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-19041 FILM NUMBER: 2504893 BUSINESS ADDRESS: STREET 1: 1375 AKRON STREET STREET 2: X CITY: COPIAGUE STATE: NY ZIP: 11726 BUSINESS PHONE: 6317892600 MAIL ADDRESS: STREET 1: 1375 AKRON STREET CITY: COPIAGUE STATE: NY ZIP: 11726 8-K 1 a8kmain.txt 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) November 26, 2001 AMERICAN BIOGENETIC SCIENCES, INC. - ------------------------------------------------------------------- (Exact Name Of Registrant As Specified In Its Charter) Delaware - ------------------------------------------------------------------- (State or Other Jurisdiction of Incorporation) 0-19041 11-2655906 - ----------------------------------- ------------------------ (Commission File Number) (I.R.S. Employer Identification No.) 1375 Akron Street, Copiague, New York 11726 - ------------------------------------------ ---------------------- (Address of Principal Executive Offices) (Zip Code) (631) 789-2600 - ------------------------------------------------------------------- (Registrant's Telephone Number, Including Area Code) Page 1 ITEM 5. OTHER EVENTS - ------- On November 26, 2001, American Biogenetic Sciences, Inc. ("ABS") issued a press release in connection with its negotiations related to distribution agreements on vaccines for human and livestock diseases ("human vaccines" and "livestock vaccines") with manufacturers of such vaccines in the Russian Federation ("Russia" or "Russian"). ABS has entered into an Exclusive Distributor Agreement, effective November 30, 2001, with the All-Russian Research Institute of Veterinary Virology and Microbiology ("Veterinary Institute"). The agreement grants ABS rights for at least 10 years to act as the Veterinary Institute's exclusive distributor outside of Russia for certain biological products related to animals, including livestock vaccines ("livestock biological products"). The Veterinary Institute owns and manufactures livestock biological products and is owned and operated by the Russian Academy of Agricultural Sciences, an organization established by the Russian government. Under its agreement with the Veterinary Institute, ABS plans to market the livestock biological products by making them available to pharmaceutical companies, government agencies and regulatory authorities outside of Russia for testing and evaluation. The terms of the sale of and specifications related to livestock biological products will be negotiated from time to time with the Veterinary Institute. The ability of ABS to sell livestock biological products, including vaccines, is subject to the results of testing and evaluation and the approval of government agencies and regulatory authorities in the relevant country or jurisdiction. ABS further plans that any sales of livestock biological products will be made through one or more sub-distributors that may arrange any necessary testing and evaluation. ABS has not signed any agreements with a sub-distributor. ABS cannot predict if and when it will receive any revenues from sales of livestock biological products. ABS is responsible for its own expenses and costs in connection with the Veterinary Institute agreement. Subsequent to November 26, 2001, ABS learned that the manufacturing facilities for human vaccines formerly owned and operated by the Russian Ministry of Health ("Ministry") had been privatized. Therefore, ABS entered into agreements called Protocols of Understanding and Mutual Support with a department of the Ministry on December 13, 2001 and with the Ministry at the Federation level on December 27, 2001, which Protocols obligate the Ministry to provide the following assistance to ABS: (1) facilitate the establishment of contracts with one or more manufacturers in Russia of certain human vaccines that would give ABS the right to market such vaccines outside of Russia; (2) facilitate the ability of ABS to obtain the licenses and permits that are necessary in Russia to acquire and export such human vaccines; and (3) monitor the manufacturing and testing of vaccine production to ensure compliance with the good manufacturing practices that are adopted in compliance with applicable Russian regulations. In conjunction with the Ministry, ABS is undertaking efforts to obtain agreements with manufacturers of human vaccines in Russia, but ABS has not yet signed any such agreements. If any such agreements are signed, ABS plans to market human vaccines by making them available to pharmaceutical companies, government agencies and regulatory authorities outside of Russia for testing and evaluation. The ability of ABS to sell human vaccines will be subject to the results of testing and evaluation and the approval by government agencies and regulatory authorities in the relevant country or jurisdiction. The terms of the sale of and specifications related to human vaccines would be negotiated from time to time with the manufacturers. ABS further plans that any sales of human vaccines will be made through one or more sub-distributors that may arrange any necessary testing and evaluation. ABS has not signed any agreements with a sub-distributor. ABS cannot predict if and when it will receive any revenues Page 2 from the sale of human vaccines. ABS will be responsible for its own expenses and costs in connection with any such manufacturer's agreement. In response to its November 26, 2001 announcement, ABS was contacted by The Nasdaq Stock Market ("Nasdaq") and requested to provide certain additional factual information with respect to the matters announced. Pending receipt of that information, Nasdaq halted trading in ABS' common stock at 10:21 a.m. on November 26. ABS provided Nasdaq with information in response to its request. ABS decided to voluntarily delist its common stock from quotation on the Nasdaq SmallCap Market effective at the close of business on January 8, 2002. Accordingly, the trading halt imposed by Nasdaq on ABS' common stock since November 26, 2001 is no longer applicable. ABS intends to have an application for quotation of its common stock filed with the NASD's OTC Bulletin Board ("OTCBB") by an NASD member firm, as soon as possible. There can be no assurance that a NASD member firm will file such application or that ABS' common stock will be accepted for quotation and trading on the OTCBB or the Pink Sheets or that broker/dealers will be willing to trade or make a market in the Company's common stock. The Russian agreements described herein involve certain risks and uncertainties, including: the results of testing and evaluation of vaccines; the ability of ABS to obtain necessary government agency and regulatory approvals of any of the vaccines; the presence of potential negative side-effects and concerns regarding the efficacy of and lack of experience of regulators with certain of these human vaccines which may inhibit approval for sale in the United States or certain other countries; the lack of experience of ABS with certain of these vaccines; the ability of ABS to consummate necessary agreements with manufacturers and sub-distributors, and to make sales of the vaccines and other biological products; the activities of competitors; changes in regulations applicable to livestock biological products and human vaccines and the administration of such regulations and other matters. Copies of the Exclusive Distributor Agreement and the Protocols of Understanding and Mutual Support are attached as exhibits to this Form 8-K. Page 3 ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS - ------ (a) FINANCIAL STATEMENTS ------------------------------- Not applicable. (b) PRO FORMA FINANCIAL INFORMATION ------------------------------- Not applicable. (c) EXHIBITS ------------------------------- 10.1 Exclusive Distributor Agreement effective as of November 30, 2001 between American Biogenetic Sciences, Inc. and the All - Russian Research Institute of Veterinary Virology and Microbiology 10.2 Protocol of Mutual Understanding and Support dated December 13, 2001 between the Ministry of Health of the Russian Federation (the Department) and American Biogenetic Sciences, Inc. 10.3 Protocol of Mutual Understanding and Support dated December 27, 2001 between the Ministry of Health of the Russian Federation and American Biogenetic Sciences, Inc. Page 4 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, thereunto duly authorized. AMERICAN BIOGENETIC SCIENCES, INC. Dated: January 9, 2002 By:_________________________________ Josef C. Schoell President, Chief Operating Officer and Chief Financial Officer Page 5 EX-10 3 a8kexh101.txt EXHIBIT 10.1 EXCLUSIVE DISTRIBUTOR AGREEMENT BETWEEN ALL - RUSSIAN RESEARCH INSTITUTE OF VETERINARY VIROLOGY AND MICROBIOLOGY AND AMERICAN BIOGENETIC SCIENCES, INC. ANIMAL VACCINES AGREEMENT EXECUTED IN BOTH ENGLISH AND RUSSIAN WITH BOTH LANGUAGE VERSIONS BEING OF EQUAL VALIDITY Page 1 EXCLUSIVE DISTRIBUTOR AGREEMENT This Agreement, effective this 30th day November, 2001, by and between American Biogenetic Sciences, Inc. ("Distributor"), a Delaware Corporation, and the All - Russian Research Institute of Veterinary Virology and Microbiology (the "VNIIVViM"). IT IS MUTUALLY AGREED THAT: 1. Definitions. (A) Products. The terms "Product" and "Products", as used in this Agreement, mean biological products (vaccines, diagnostics kids, biological active products). (B) Territory. The term "Territory" as used in this Agreement shall be defined as the world, except for the Russian Federation (former USSR). 2. Appointment. Subject to the terms and conditions of this Agreement, VNIIVViM hereby appoints the Distributor on an exclusive basis to promote and sell the Products in the Territory, and Distributor accepts such appointment upon the terms and conditions herein stated. Distributor will be the exclusive Distributor of the Products, and Distributor shall retain the right to assign sub-Distributors or sales agents for the sales of the Products in the Territory. 3. Sales Promotion. Distributor agrees to use reasonable commercial effort to promote the sale of the Products in the Territory. 4. Product Purchase. (A) Product Prices. The price of the Products that VNIIVViM manufactures or has manufactured, for the Distributor shall be negotiated by the parties from time to time. Products may be delivered in bulk or in dispensing units as needed by Distributor. B) Point of Shipment. All of the prices for the Products sold to the Distributor are F.O.B. the VNIIVViM, Pokrov, Vladimirskaya oblast, Russia. Title to the Products passes to the Distributor at the time delivery of the Products on any appropriate carrier to Distributor is completed. The Distributor shall be responsible for the payment of all import arrangements including taxes, duties, import licenses and appropriate import documents. (C) Specifications. Parties shall agree to specifications as to quality, packaging and labeling. (D) Payment. Invoices are due and payable on or before the ninety (90) days following the date VNIIVViM invoices and delivers Products to the Distributor. 1 Note: the word "kids" in the section on "Products" is a typographical error and should be "kits". Page 2 (E) Purchase Order Acceptance. Purchase contracts between the Distributor and VNIIVViM are binding when VNIIVViM its notice of acceptance of Distributor's purchase order within ten (10) days. (F) Order Fulfillment. VNIIVViM agrees that it will use its reasonable commercial efforts to fill the accepted orders as promptly as practicable. 5. Distributor's, Relationships and Conduct of Business. (A) It is agreed and understood that the Distributor is an independent contractor. (B) Any expenses or costs which the Distributor incurs under this Agreement, and any other expenses incurred by the Distributor to operate pursuant to this Agreement shall be paid and borne by Distributor. 6. Term and Termination. (A) This Agreement shall be for a term of ten (10) years from the date hereof, and shall automatically extend for one (1) year periods, unless VNIIVViM or Distributor give one (1) year prior written notice of termination. (B) If either party breaches a material term of this Agreement the other party shall be allowed to terminate this Agreement if an adequate remedy to cure the breach has not been implemented within ninety (90) days after written notice. 7. Quality Assurance Rights and Obligations. (A) VNIIVViM shall manufacture, or have manufactured, and test the Products in accordance with written procedures, and shall document conformance of the manufacture and testing of each lot with such written procedures. VNIIVViM shall implement Quality Assurance procedures to assure that such written manufacturing and testing procedures are followed and that the manufacturing and testing of each lot of Product are properly documented. VNIVViM warrants that all Products supplied to Distributor will (i) conform to mutually acceptable Good Manufacturing Practices for the Russian and U. S. Government rules and regulations, (ii) be free of defects in material, design and workmanship, and (iii) conform to specifications agreed to between VNIIVViM and Distributor. To confirm compliance with these requirements, VNIIVViM will provide to Distributor a certificate of compliance with each shipment of the Products delivered to Distributor hereunder. 8. Notices. All notices, requests, consents and other communications hereunder shall be in writing, shall be addressed to the receiving party's address set forth below or to such other address as a party may designate by notice hereunder, and shall be either (i) delivered by hand, (ii) made by telecopy or facsimile transmission and e-mail, (iii) sent by recognized national overnight courier service, or (iv) sent by registered mail, return receipt requested, postage prepaid. Page 3 If to Distributor: If to VNIIVViM: Alfred J. Roach, Chairman and CEO Vitaly M. KOTLYAROV American Biogenetic Sciences, Inc. Director 1375 Akron Street Copiague, New York Tel./Fax: (09243) 6-21-25 Tel: 631-789-2600 Fax: 631-789-1661 E-mail: VNIIVViM@niiv.petush.elcom.ru E-mail: info@mabxa.com 9. Distributor Manufacturing. Distributor reserves the right to manufacture, or have manufactured, or have filled, the Products on terms to be agreed upon. 10. Assignment. Distributor shall have the right to assign or transfer this Agreement, to one or more third parties. 11. Entire Agreement. This Agreement contains the entire understanding of the parties hereto with respect to the transactions contemplated and may only be amended or modified if reduced to writing and signed by both parties. 12. Governing Law. This Agreement and any modifications and additions thereto shall be governed in accordance with the laws of Russia. The parties agrees to submit to the jurisdiction of the courts of the Russia. 13. Captions, Headings, or Titles. All captions, headings or titles in the sections of the Agreement are inserted for convenience of reference only and shall not constitute a part of this Agreement or a limitation of scope of the particular sections to which they apply. 14. Counterparts. This Agreement may be signed in counterparts and shall become effective as if executed in a single, complete document as of the date hereof upon its execution by both parties. Facsimile signatures of the undersigned parties will have the same force and effect as original signatures. 15. Disputes and Arbitration. Any controversy or claim arising out of or relating to this Agreement shall be settled by binding arbitration by the International Court of Arbitration of the International Chamber of Commerce (the "ICC") in accordance with the ICC Rules of Arbitration in effect at the time of the arbitration. The arbitration proceedings shall be conducted in Geneva, Switzerland and in the English language. There shall be three (3) arbitrators, one of whom shall be selected by the party seeking to initiate the arbitration, one by the other party and the third by the two arbitrators so selected. The arbitration award shall be given in writing and shall be final and binding on the parties with respect to the subject matter in controversy. The parties shall keep confidential the arbitration proceedings and terms of any arbitration award, except as may otherwise be required by law. Each party shall bear its own legal fees and other costs related to the arbitration, except that the arbitrators shall determine who shall bear the costs of the arbitrators. The arbitrators may determine arbitrability but may not award punitive damages or limit, expand or otherwise modify the terms of this Agreement. Page 4 In Witness Whereof, VNIVViM and the Distributor have duly signed and executed this Agreement effective as of the date first written above. By /s/ Vitaly M. KOTLYAROV By /s/ Alfred J. Roach ---------------------------- --------------------------------- VNIVViM Distributor: Vitaly M. KOTLYAROV Alfred J. Roach Director Chairman and CEO American Biogenetic Sciences, Inc. Page 5 EX-10 4 a8kexh102.txt EXHIBIT 10.2 PROTOCOL OF MUTUAL UNDERSTANDING AND SUPPORT This Protocol of Mutual Understanding and Support between the Ministry of Health of the Russian Federation (the "Department"), acting on the basis of the Regulations on the Ministry of Health of the Russian Federation, and American Biogenetic Sciences, Inc. ("ABS"), represented by Alfred J. Roach, Chairman of the Board of Directors and Head of ABS, acting on the basis of its Charter, was executed on December 13, 2001. WHEREAS: A. The Ministry and ABS are equally concerned with the increased danger of dissemination of infectious diseases in the United States of America and the rest of the world in connection with the threat of bio-terrorism; B. The Ministry of Health has declared its desire to support the United States of America and other countries in preventing and fighting anthrax, smallpox and other infectious diseases; C. ABS is a U.S. company involved in preventing and fighting infectious and other diseases and has close and long-term contacts with research institutes in the Russian Federation; and D. The Department and ABS have held meetings and have reached understanding with regard to certain matters related to the cooperation in the sphere of distribution of vaccines. The Department and ABS hereby express their understanding in this respect as follows: 1. Cooperation. The Department will support ABS by identifying qualified manufacturers of the anthrax vaccine, smallpox vaccine and other human vaccines (the "Vaccines"), and will facilitate the establishment of contractual relationships with such manufacturers and the promotion and sales of the Vaccines in the United States of America and other countries of the world. The Department will also assist ABS in obtaining such licenses and permits as may be required in connection with the acquisition of the Vaccines by ABS and the export thereof from the territory of the Russian Federation. 2. Contracts with the Manufacturers. ABS undertakes that all contracts with the Vaccine Manufacturers will be concluded on the terms fully complying with the laws of the Russian Federation and other applicable regulations. ABS agrees and understands that it shall be its obligation to negotiate with the Vaccine Manufacturers, in particular, to negotiate prices, points of shipment, specifications, warranties, payment and other terms and conditions of contracts between ABS and Vaccine Manufacturers. 3. Quality Assurance. Department and ABS understand and agree that the Vaccines will be Page 1 manufactured and tested in accordance with special agreements in writing reached between ABS and the Vaccine Manufacturers subject to applicable standards and requirements of the laws of the Russian Federation. The Department, within its competence, will monitor the manufacturing and testing of the Vaccines in order to ensure compliance with mutually acceptable Good Manufacturing Practices adopted in compliance with the rules and regulations approved in the Russian Federation. 4. Notices. All notices, requests, consents and other communications between the Parties hereunder shall be in writing, shall be addressed to the receiving Party's address set forth below or to such other address as a Party may designate by notice hereunder, and shall be either (i) delivered by hand, (ii) made by telecopy or facsimile transmission and e-mail, (iii) sent by recognized national overnight courier service, or (iv) sent by registered mail, return receipt requested, postage prepaid. If to Department: Ministry of Health - The Russian Federation NWFO Department on coordination Questions of Public Health Services Piskrevsky pr., 47 St. Petersburg, 195067, Russia Tel: (812) 544-3460 Fax: (812) 543-14-73 If to ABS: Alfred J. Roach Chairman and CEO American Biogenetic Sciences, Inc. 1375 Akron Street Copiague, New York Tel: +1-631-789-2600 Fax: + 1-631-789-1661 In witness of their understanding on these matters the Department and ABS have duly signed and executed this Protocol of Understanding and Support in the City of Moscow. Ministry of Health of American Biogenetic Sciences, Inc. the Russian Federation By: /s/ Alexandr S. Tverdohlebov By: /s/ Alfred J. Roach -------------------------------------- --------------------------- Name: Alexandr S. Tverdohlebov Alfred J. Roach Title: Chief of Department Chairman and CEO AGREEMENT EXECUTED IN BOTH ENGLISH AND RUSSIAN WITH BOTH LANGUAGE VERSIONS BEING OF EQUAL VALIDITY Page 2 EX-10 5 a8kexh103.txt EXHIBIT 10.3 PROTOCOL OF MUTUAL UNDERSTANDING AND SUPPORT This Protocol of Mutual Understanding and Support between the Ministry of Health of the Russian Federation (the "Ministry"), acting on the basis of the Regulations on the Ministry of Health of the Russian Federation, and American Biogenetic Sciences, Inc. ("ABS"), represented by Alfred J. Roach, Chairman of the Board of Directors and Head of ABS, acting on the basis of its Charter, was executed on December 27, 2001. WHEREAS: A. The Ministry and ABS are equally concerned with the increased danger of dissemination of infectious diseases in the United States of America and the rest of the world in connection with the threat of bio-terrorism; B. The Ministry has declared its desire to support the United States of America and other countries in preventing and fighting anthrax, smallpox and other infectious diseases; C. ABS is a U.S. company involved in preventing and fighting infectious and other diseases and has close and long-term contacts with research institutes in the Russian Federation; and D. The Ministry and ABS have held meetings and have reached understanding with regard to certain matters related to the cooperation in the sphere of distribution of vaccines. The Ministry and ABS hereby express their understanding in this respect as follows: 1. Cooperation. The Ministry will support ABS by identifying qualified manufacturers of the anthrax vaccine, smallpox vaccine and other human vaccines (the "Vaccines"), and will facilitate the establishment of contractual relationships with such manufacturers and the promotion and sales of the Vaccines in the United States of America and other countries of the world. The Ministry will also assist ABS in obtaining such licenses and permits as may be required in connection with the acquisition of the Vaccines by ABS and the export thereof from the territory of the Russian Federation. 2. Contracts with the Manufacturers. ABS undertakes that all contracts with the Vaccine Manufacturers will be concluded on the terms fully complying with the laws of the Russian Federation and other applicable regulations. ABS agrees and understands that it shall be its obligation to negotiate with the Vaccine Manufacturers, in particular, to negotiate prices, points of shipment, specifications, warranties, payment and other terms and conditions of contracts between ABS and Vaccine Manufacturers. 3. Quality Assurance. Ministry and ABS understand and agree that the Vaccines will be manufactured and tested in accordance with special agreements in writing reached between Page 1 ABS and the Vaccine Manufacturers subject to applicable standards and requirements of the laws of the Russian Federation. The Ministry, within its competence, will monitor the manufacturing and testing of the Vaccines in order to ensure compliance with mutually acceptable Good Manufacturing Practices adopted in compliance with the rules and regulations approved in the Russian Federation. 4. Notices. All notices, requests, consents and other communications between the Parties hereunder shall be in writing, shall be addressed to the receiving Party's address set forth below or to such other address as a Party may designate by notice hereunder, and shall be either (i) delivered by hand, (ii) made by telecopy or facsimile transmission and e-mail, (iii) sent by recognized national overnight courier service, or (iv) sent by registered mail, return receipt requested, postage prepaid. If to Ministry: Katlinksy Anton Vikentievich Deputy Minister Ministry of Health 18/20 Vadkovsky pereulok Moscow, Russia Tel: 292 3457 Fax: 927 2570 If to ABS: Alfred J. Roach Chairman and CEO American Biogenetic Sciences, Inc. 1375 Akron Street Copiague, New York Tel: +1-631-789-2600 Fax: + 1-631-789-1661 In witness of their understanding on these matters the Ministry and ABS have duly signed and executed this Protocol of Understanding and Support in the City of Moscow. Ministry of Health of the American Biogenetic Sciences, Inc. Russian Federation By: /s/ Katlinksy A.V. By: /s/ Alfred J. Roach -------------------------------------- --------------------------- Name: Katlinsky A.V. Alfred J. Roach Title: Deputy Minister Chairman and CEO AGREEMENT EXECUTED IN BOTH ENGLISH AND RUSSIAN WITH BOTH LANGUAGE VERSIONS BEING OF EQUAL VALIDITY Page 2 -----END PRIVACY-ENHANCED MESSAGE-----