-----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, GJ4mvH+S54EHXlqbM9OuQW0TMpwurGdSNbSHuTNR0MK2dvlsB4mzlg3awAFTmKdl mVPc6DmhFZA0MZyptvh8YA== 0000912057-02-026513.txt : 20020703 0000912057-02-026513.hdr.sgml : 20020703 20020703171122 ACCESSION NUMBER: 0000912057-02-026513 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20020626 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20020703 FILER: COMPANY DATA: COMPANY CONFORMED NAME: IMMUNE RESPONSE CORP CENTRAL INDEX KEY: 0000817785 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 330255679 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-18006 FILM NUMBER: 02696732 BUSINESS ADDRESS: STREET 1: 5935 DARWIN COURT CITY: CARLSBAD STATE: CA ZIP: 92008 BUSINESS PHONE: 6194317080 MAIL ADDRESS: STREET 1: 5935 DARWIN COURT CITY: CARLSBAD STATE: CA ZIP: 92008 8-K 1 a2083790z8-k.htm FORM 8-K
QuickLinks -- Click here to rapidly navigate through this document

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: June 26, 2002
(Date of earliest event reported)

THE IMMUNE RESPONSE CORPORATION
(Exact name of registrant as specified in its charter)

Delaware
(State or other jurisdiction of incorporation)
  0-18006
(Commission File Number)
  33-0255679
(IRS Employer Identification No.)

5935 Darwin Court, Carlsbad, California 92008
(Address of principal executive offices)        (Zip Code)

Registrant's telephone number, including area code: (760) 431-7080





Item 5.    Other Events

        The Immune Response Corporation announced a significant restructuring of its REMUNE® license and collaboration contract with Trinity Medical Group USA, Inc.

        The amended contract provides for manufacturing costs and mark-up plus $50.00 per unit to be paid to Immune Response, which obligation would expire upon the earlier of the first one million doses of REMUNE® purchased by the Trinity Medical Group or December 31, 2007. As consideration for the increased purchase price to be paid to Immune Response, Trinity Medical Group will receive shares of Immune Response common stock and a waiver of the final $5 million common stock purchase obligation, which would have applied in the event of the optional technology transfer of REMUNE® manufacturing rights in Trinity Medical Group's licensed territory.

        Trinity Medical Group will receive four million shares of restricted Immune Response common stock immediately and up to another three million shares upon the occurrence of certain sales milestones. All of the restricted shares are subject to registration rights. If REMUNE® is approved for use by the Thai government, Trinity Medical Group will be obligated to purchase two million shares of common stock in exchange for a $5 million payment. Under the terms of the original agreement, Trinity Medical Group would have been obligated to purchase 333,333 shares of Immune Response stock in exchange for a $5 million payment upon Thai government approval.

        The previous supply contract with Trinity Medical Group, dating back to 1995, called for Immune Response to receive the unit cost of production plus an agreed upon mark up percentage, which would have resulted in significantly less revenues than the just-completed agreement.

        Co-founded by medical pioneer, Dr. Jonas Salk and based in Carlsbad, California, The Immune Response Corporation is a biopharmaceutical company developing immune-based therapies designed to treat HIV, autoimmune diseases and cancer. The Company also develops and holds patents on several technologies that can be applied to genes in order to increase gene expression or effectiveness, making it useful in a wide range of therapeutic applications for a variety of disorders.

        This Form 8-K contains forward-looking statements. Actual results could vary materially from those expected due to a variety of risk factors, including, but not limited to, whether REMUNE® will be approved in Thailand, whether Trinity Medical Group will purchase any shares from the Company, whether the Company will receive any revenues from Trinity for the sale of REMUNE®, whether the Company will successfully raise proceeds from financing activities, that Transamerica will not in the future declare that the Company is in default of its debt arrangements, accelerate the Company's debt and seize its assets, whether data generated from previous trials can be replicated in future clinical trials, whether clinical trials will be successfully concluded, whether REMUNE® will be approved for marketing or be successfully commercialized and whether the Company will be able to obtain additional financing. Those factors are discussed more thoroughly in The Immune Response Corporation's SEC filings, including but not limited to its report on Form 10-K for the year ended December 31, 2001 and report on Form 10-Q for the quarter ended March 31, 2002. The Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements, which may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

        REMUNE® is a registered trademark of The Immune Response Corporation.

2




ITEM 7.    FINANCIAL STATEMENTS AND EXHIBITS

EXHIBITS

  DESCRIPTION
10.1   Amendment No. 3 to the License and Collaboration Agreement dated September 29, 2000

10.2

 

Amendment No. 2 to the License and Collaboration Agreement dated September 29, 2000

10.3(1)

 

Amendment No. 1 to the License and Collaboration Agreement dated September 29, 2000

10.4(2)

 

Assignment Agreement between Trinity Medical Group, Ltd. and Trinity USA dated August 3, 2000

10.5(3)

 

License and Collaboration Agreement between Trinity Medical Group, Ltd. and The Immune Response Corporation dated September 15, 1995

10.6

 

Amendment No. 1 to Stock Purchase Agreement between Trinity Medical Group, Ltd. and The Immune Response Corporation dated September 15, 1995

10.7(4)

 

Stock Purchase Agreement between Trinity Medical Group, Ltd. and The Immune Response Corporation dated September 15, 1995

(1)
Incorporated by reference to Exhibit 10.3 to Amendment No. 1 to Form SB-2 filed by Trinity Medical Group USA, Inc. on December 22, 200 with the SEC.

(2)
Incorporated by reference to Exhibit 10.4 to Amendment No. 1 to Form SB-2 filed by Trinity Medical Group USA, Inc. on December 22, 200 with the SEC.

(3)
Incorporated by reference to Exhibit 10.7 to Amendment No. 1 to Form SB-2 filed by Trinity Medical Group USA, Inc. on December 22, 200 with the SEC.

(4)
Incorporated by reference to Exhibit 10.8 to Amendment No. 1 to Form SB-2 filed by Trinity Medical Group USA, Inc. on December 22, 200 with the SEC.

3



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.

        Dated: July 3, 2002

    THE IMMUNE RESPONSE CORPORATION

 

 

By

 

/s/  
MICHAEL L. JEUB      
Michael L. Jeub
Vice President, Finance and Chief Financial Officer

4



EXHIBIT INDEX

Exhibit

  Description
10.1   Amendment No. 3 to the License and Collaboration Agreement dated September 29, 2000

10.2

 

Amendment No. 2 to the License and Collaboration Agreement dated September 29, 2000

10.3(1)

 

Amendment No. 1 to the License and Collaboration Agreement dated September 29, 2000

10.4(2)

 

Assignment Agreement between Trinity Medical Group, Ltd. and Trinity USA dated August 3, 2000

10.5(3)

 

License and Collaboration Agreement between Trinity Medical Group, Ltd. and The Immune Response Corporation dated September 15, 1995

10.6

 

Amendment No. 1 to Stock Purchase Agreement between Trinity Medical Group, Ltd. and The Immune Response Corporation dated September 15, 1995

10.7(4)

 

Stock Purchase Agreement between Trinity Medical Group, Ltd. and The Immune Response Corporation dated September 15, 1995

(1)
Incorporated by reference to Exhibit 10.3 to Amendment No. 1 to Form SB-2 filed by Trinity Medical Group USA, Inc. on December 22, 200 with the SEC.

(2)
Incorporated by reference to Exhibit 10.4 to Amendment No. 1 to Form SB-2 filed by Trinity Medical Group USA, Inc. on December 22, 200 with the SEC.

(3)
Incorporated by reference to Exhibit 10.7 to Amendment No. 1 to Form SB-2 filed by Trinity Medical Group USA, Inc. on December 22, 200 with the SEC.

(4)
Incorporated by reference to Exhibit 10.8 to Amendment No. 1 to Form SB-2 filed by Trinity Medical Group USA, Inc. on December 22, 200 with the SEC.

5




QuickLinks

SIGNATURE
EXHIBIT INDEX
EX-10.1 3 a2083790zex-10_1.htm EXHIBIT 10.1
QuickLinks -- Click here to rapidly navigate through this document


Exhibit 10.1


AMENDMENT NO. 3 TO LICENSE AND COLLABORATION AGREEMENT

        THIS AMENDMENT NO. 3 TO LICENSE AND COLLABORATION AGREEMENT (this "Amendment"), effective as of June 26, 2002 (the "Effective Date") is entered into by and between THE IMMUNE RESPONSE CORPORATION, a Delaware corporation ("IRC"), and TRINITY MEDICAL GROUP USA, INC., a Florida corporation ("Trinity"), with respect to the following facts.

RECITALS

        A.    IRC and Trinity Medical Group, Co., Ltd., a Thai limited company ("Trinity Thailand"), entered into the License and Collaboration Agreement dated as of September 15, 1995, which was amended on September 29, 2000, by the Amendment No. 1 to License and Collaboration Agreement, and on May 8, 2001, by the Amendment No. 2 to License and Collaboration Agreement (collectively the "Agreement").

        B.    Pursuant to the Assignment Agreement dated as of August 3, 2000, between Trinity Thailand and Trinity, Trinity Thailand assigned to Trinity and Trinity assumed, all of Trinity Thailand's rights and obligations under the Agreement.

        C.    The parties now desire to amend the Agreement on the terms and conditions set forth below.

        D.    In consideration for amending the Agreement, IRC shall issue up to 7,000,000 shares of its common stock to Trinity upon the terms and conditions set forth below.

        NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants set forth below, the parties amend the Agreement and otherwise agree as follows:

ARTICLE 1
AMENDMENT OF AGREEMENT

        1.1  Section 6.3.1(c) of the Agreement shall be restated in its entirety to read as follows:

            (c)  With respect to commercial supply under Section 6.1.2 above, Trinity shall purchase Product from IRC at the following purchase price per dose (the "Purchase Price"):

                (i)  For each dose of Product purchased by Trinity under Section 6.1.2 through the first to occur of the purchase by Trinity under Section 6.1.2 of one million (1,000,000) doses of Product in the aggregate, and December 31, 2007, the Purchase Price shall equal the sum of (A) one hundred ten percent (110%) of IRC's Manufacturing Cost for such dose of Product, plus (B) US$50.00; provided, however that the Purchase Price under this Section 6.3.1(c)(i) shall not exceed US$132.00.

              (ii)  For each dose of Product purchased by Trinity under Section 6.1.2 following the first to occur of the purchase by Trinity under Section 6.1.2 of one million (1,000,000) doses of Product in the aggregate, and December 31, 2007, the Purchase Price shall equal one hundred ten percent (110%) of IRC's Manufacturing Cost for such dose of Product.

        1.2  Section 6.6.1 of the Agreement shall be restated in its entirety to read as follows:

            Delivery. IRC's obligation to deliver Products under this Agreement shall be subject to obtaining all necessary consents, approvals, authorizations and licenses of the applicable governmental and regulatory authorities for the manufacture, export and delivery of Products under this Agreement. IRC shall use commercially reasonable efforts to obtain such necessary consents, approvals, authorizations and licenses, and Trinity shall cooperate with IRC in obtaining such consents, approvals, authorizations and licenses. IRC's obligation to deliver Products under this Agreement additionally shall be subject to IRC having sufficient validated and operational manufacturing capacity to satisfy Trinity's reasonably foreseeable forecasted requirements for


    Products in the Territory for use in the Field. IRC shall use commercially reasonable efforts to cause its manufacturing facility for Products to have sufficient validated and operational capacity to meet the reasonably foreseeable forecasted demand requirements of Trinity for Products as soon as reasonably feasible following marketing approval of Products in the Territory for use in the Field. All Products supplied under the Agreement shall be shipped f.o.b. place of manufacture. Title and risk of loss and damages to the Products shall pass to Trinity upon release to Trinity's designated carrier.

ARTICLE 2
ISSUE OF IRC SHARES

        2.1  On the terms and conditions of this Amendment, IRC shall issue to Trinity the following number, up to an aggregate of seven million (7,000,000), of shares of IRC's common stock (the "Shares") upon achievement of the following milestones (each a "Closing"):

            2.1.1    IRC shall issue to Trinity four million (4,000,000) of the Shares on the Effective Date.

            2.1.2    IRC shall issue to Trinity one million (1,000,000) of the Shares within thirty days following the date on which Trinity purchases under Section 6.1.2 of the Agreement, and irrevocably pays to IRC the applicable Purchase Price for, an aggregate of three hundred thousand (300,000) doses of Product.

            2.1.3    IRC shall issue to Trinity one million (1,000,000) of the Shares within thirty days following the date on which Trinity purchases under Section 6.1.2 of the Agreement, and irrevocably pays to IRC the applicable Purchase Price for, an aggregate of six hundred thousand (600,000) doses of Product.

            2.1.4    IRC shall issue to Trinity one million (1,000,000) of the Shares within thirty days following the date on which Trinity purchases under Section 6.1.2 of the Agreement, and irrevocably pays to IRC the applicable Purchase Price for, an aggregate of one million (1,000,000) doses of Product.

        2.2  IRC's obligation to issue the Shares pursuant to this Article 2 shall terminate, with respect to all Shares not previously issued pursuant to this Article 2, on December 31, 2007.

        2.3  For purposes of this Amendment, "Share" or "Shares" refers to the class of common stock of IRC in existence as of May 30, 2002. Any subsequent split of the Shares as authorized by the stockholders of IRC shall increase or decrease the number of Shares that remain to be issued pursuant to this Article 2 by the same factor as the split is computed.

        2.4  As a condition precedent to the effectiveness of this Amendment, the parties shall have duly executed and delivered Amendment No. 1 to Stock Purchase Agreement, dated as of the Effective Date, which shall:

            2.4.1    Eliminate Trinity's $5,000,000 stock purchase commitment which would have arisen upon IRC's transfer of certain manufacturing technology to Trinity; and

            2.4.2    Reduce the per share cost from $15 to $2.50 for Trinity's $5,000,000 stock purchase commitment which arises on the date that is thirty (30) days after the date on which Trinity receives the required marketing approval from the governing health authority of Thailand for the Product.

2



ARTICLE 3
REGISTRATION RIGHTS

        At the request of Trinity, IRC agrees to file up to four registration statements under the Securities Act of 1933, as amended (the "Act"), with the Securities and Exchange Commission ("SEC") to register the Shares issued pursuant to Article 2 of this Amendment, as soon as practicable after receipt of the request from Trinity following the respective Closings. IRC shall use reasonable commercial efforts to respond to comments of the SEC within ten (10) business days of receipt of said comments and will use commercially reasonable efforts to cause the registration statement to be declared effective by the SEC within ninety (90) days of the receipt of the request from Trinity. IRC shall keep the registration statement continuously effective until the date occurring one year following the date on which the obligation to issue the Shares terminates pursuant to Article 2. IRC shall cause the related prospectus to be amended or supplemented by a required prospectus supplement pursuant to Rule 424 under the Act. Notwithstanding the foregoing, IRC may delay the filing of the registration statement for 180 days after receipt of the request from Trinity, if it furnishes to Trinity a certificate signed by the Chairman of the Board of Directors of IRC stating, it would be seriously detrimental to IRC and its stockholders for such registration statement to be filed and that it is therefore, essential to delay the filing of the registration statement.

ARTICLE 4
REPRESENTATIONS AND WARRANTIES OF IRC

        IRC hereby represents and warrants to Trinity that:

        4.1  IRC is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware and has all requisite corporate power and authority to carry on its business as now conducted. IRC is duly qualified to transact business and is in good standing in each jurisdiction in which the failure so to qualify would have a material adverse effect on IRC.

        4.2  All corporate action on the part of IRC, its officers, directors and stockholders necessary for (a) the authorization, execution and delivery of the Amendment, (b) the performance of all obligations of IRC hereunder, and (c) the authorization, issuance (or reservation for issuance) and delivery of the Shares being sold hereunder has been taken and the Amendment constitutes the valid and legally binding obligation of IRC, enforceable against IRC in accordance with its terms.

        4.3  The Shares which are being purchased by Trinity hereunder, when issued, sold and delivered in accordance with the terms hereof, for the consideration expressed herein, will be duly and validly issued, fully paid and nonassessable and, based in part upon the representations of Trinity in Article 5 of this Amendment, will be issued in compliance with applicable securities laws.

ARTICLE 5
REPRESENTATIONS AND WARRANTIES OF TRINITY

        Trinity hereby represents, warrants, acknowledges and covenants to IRC as follows:

        5.1  Trinity has the full right, power and authority to enter into this Amendment. This Amendment constitutes Trinity's valid and legally binding obligation, enforceable against Trinity in accordance with its terms.

        5.2  Trinity is an Accredited Investor as defined under Regulation D promulgated under the Act.

        5.3  Trinity understands and acknowledges that Shares will be issued to Trinity in reliance upon Trinity's representations to IRC, evidenced by Trinity's execution of this Amendment. Trinity is acquiring the Shares for investment for its own account, not as nominee or agent, and not with a view

3



to, or for resale in connection with, any distribution or public offering thereof within the meaning of the Act and state securities laws.

        5.4  Trinity understands and acknowledges that the Shares will not be registered under the Act or qualified under any blue-sky laws on the grounds that the offering and sale of the Shares contemplated by this Amendment are exempt from registration under the Act pursuant to Section 4(2) thereof and exempt from registration or qualification pursuant to state blue-sky laws, and other applicable laws, and that IRC's reliance upon such exemptions is predicated upon Trinity's representations set forth in this Amendment. Trinity acknowledges and understands that the Shares must be held indefinitely unless the Shares are subsequently registered under the Act and qualified under applicable blue-sky laws or an exemption from such registration and such qualification is available.

        5.5  Trinity is aware of the provisions of Rule 144 promulgated under the Act which permit limited resale of stock purchased in a private placement subject to the satisfaction of certain conditions, including, among other things, the existence of a public market for the stock, the availability of certain current public information about IRC, the resale occurring not less than one year after a party has purchased and paid for the stock to be sold, the sale being through a "broker's transaction" or a transaction directly with a "market maker" and the number of shares of the stock being sold during any three-month period not exceeding specified limitations. Trinity further acknowledges and understands that IRC may not be satisfying the current public information requirement of Rule 144 at the time Trinity wishes to sell the Shares and, if so, Trinity would be precluded from selling the Shares under Rule 144 even if the one year minimum holding period has been satisfied.

        5.6  Trinity is an investor in securities of companies in the development stage and acknowledges that it is able to fend for itself, can bear the economic risk of its investment and has such knowledge and experience in financial or business matters that it is capable of evaluating the merits and risks of the investment in the Shares. Trinity has been furnished with and has had access to such information as Trinity considered necessary to make a determination as to the purchase of the Shares.

        5.7  Trinity understands that no public market currently exists for the Shares, and that there can be no guaranty that a public market will ever exist for the Shares.

        5.8  Each certificate representing the Shares may be endorsed with the following legends:

            5.8.1    "THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE "ACT") AND ARE "RESTRICTED SECURITIES" AS DEFINED IN RULE 144 PROMULGATED UNDER THE ACT. THE SECURITIES MAY NOT BE SOLD OR OFFERED FOR SALE OR OTHERWISE DISTRIBUTED EXCEPT (i) IN CONJUNCTION WITH AN EFFECTIVE REGISTRATION STATEMENT FOR THE SHARES UNDER THE ACT OR (ii) IN COMPLIANCE WITH RULE 144, OR (iii) PURSUANT TO AN OPINION OF COUNSEL, SATISFACTORY TO IRC, THAT SUCH REGISTRATION OR COMPLIANCE IS NOT REQUIRED AS TO SAID SALE, OFFER OR DISTRIBUTION."

            5.8.2    Any other legends required by applicable law or regulation.

        5.9  Any legend endorsed on a certificate and the restrictions on transfer instructions with respect to such legended Shares shall be removed, and IRC shall issue a certificate without such legend to the holder of such Shares if such Shares are registered and sold under the Act and a prospectus meeting the requirements of Section 10 of the Act is available or if such holder satisfies the requirements of Rule 144(k) and, where reasonably deemed necessary by IRC, provides IRC with an opinion of counsel for such holder of the Shares, reasonably satisfactory to IRC, to the effect that (i) such holder, meets the requirements of Rule 144(k) or (ii) a public sale, transfer or assignment of such Shares may be made without registration.

4


ARTICLE 6
MISCELLANEOUS

        6.1  All terms used, but not defined, in this Amendment shall have the respective meanings set forth in the Agreement.

        6.2  This Amendment shall be effective for all purposes as of the Effective Date. Except as otherwise expressly modified by this Amendment, the Agreement shall remain in full force and effect in accordance with its terms.

        6.3  This Amendment shall be governed by, interpreted and construed in accordance with the laws of the State of California, without regard to conflict of law principles.

        6.4  This Amendment may be executed in counterparts, each of which shall be deemed to be an original and together shall be deemed to be one and the same document.

        IN WITNESS WHEREOF, the undersigned have duly executed and delivered this Amendment effective as of the Effective Date.

    THE IMMUNE RESPONSE CORPORATION

 

 

By

 

 
       
Dr. Dennis J. Carlo
President and CEO

 

 

TRINITY MEDICAL GROUP USA, INC.

 

 

By

 

 
       
President

 

 

By

 

 
       
Chief Executive Officer

5




QuickLinks

AMENDMENT NO. 3 TO LICENSE AND COLLABORATION AGREEMENT
EX-10.2 4 a2083790zex-10_2.htm EXHIBIT 10.2
QuickLinks -- Click here to rapidly navigate through this document


Exhibit 10.2


AMENDMENT NO. 2 TO LICENSE AND COLLABORATION AGREEMENT

THIS AMENDMENT NO. 2 TO LICENSE AND COLLABORATION AGREEMENT (this "Amendment"), effective as of May 8, 2001 (the "Effective Date") is entered into by and between THE IMMUNE RESPONSE CORPORATION, a Delaware corporation ("IRC"), and TRINITY MEDICAL GROUP USA, INC., a Florida corporation ("Trinity"), with respect to the following facts.


RECITALS

        A. IRC and Trinity Medical Group, Co., Ltd., a Thai limited company ("Trinity Thailand"), entered into the License and Collaboration Agreement dated as of September 15, 1995, which was amended on September 29, 2000, by the Amendment No. 1 to License and Collaboration Agreement (the "Amendment No. 1") (collectively the "Agreement").

        B. Pursuant to the Assignment Agreement dated as of August 3, 2000, between Trinity Thailand and Trinity, Trinity Thailand assigned to Trinity and Trinity assumed, all of Trinity Thailand's rights and obligations under the Agreement.

        C. The parties now desire to amend the Agreement on the terms and conditions set forth below.

        NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants set forth below, the parties amend the Agreement and otherwise agree as follows:


ARTICLE 1 AMENDMENT

        1.1 Section 1.8 of the Agreement shall be deleted in its entirety and restated to read as follows:

            "Manufacturing Cost" shall mean the fully-burdened cost, expressed on a per unit manufacturing basis, of manufacturing the Product, together with the packaging thereof, including the cost of materials, direct labor and benefits, overhead, all as determined in accordance with generally accepted accounting principles ("GAAP"), and excess capacity related cost, consistent with the manufacturer's accounting practices for other products manufactured. Materials, direct labor and benefits, overhead, and excess capacity related cost shall be further defined as follows:

              1.8.1"Materials" shall include those items which form an integral and direct part of the bulk form of the Product and are necessary for its production, as well as cartons, labels, package inserts and shippers.

              1.8.2"Direct Labor and Benefits" shall include that portion of basic wages, labor and related payroll taxes and employee benefits spent in actual production of the particular Product which can be identified with or charged to the Product.

              1.8.3"Overhead" shall include without limitation all operating expenses incurred by and in support of the particular manufacturing cost centers, purchasing department and quality assurance operations, with respect to the Product, including without limitation the following:

        Indirect labor, related payroll taxes and employee benefits

        Depreciation

        Taxes

        Insurance

        Rent

        Repairs and maintenance

        Supplies

        Utilities

        Factory administrative expenses

              1.8.4"Excess Capacity Related Cost" shall include any and all costs, as defined in Sections 1.8.1 - 1.8.3 above, that are associated with underutilization of REMUNE™ plant capacity that may otherwise be charged to expense in the period incurred.

        1.2  Section 1.18 shall be added to the Agreement as follows:

            1.18 "Production" shall mean the actual production, as determined at the end of each month, of IRC's current and future manufacturing facility(s) which produces the Product.

        1.3  Section 6.1.2 of the Agreement shall be deleted in its entirety and restated to read as follows:

            For Commercial Sale and Distribution. IRC shall manufacture, sell and deliver to Trinity such amounts of the Product, as Trinity reasonably requests pursuant to the provisions of Section 6.4 below, equal to Trinity's requirement of the Product for commercial sale and distribution in the Territory for use in the Field, up to twenty-five percent (25%) of IRC's Production for the Product. In the event Trinity's requirement of the Product for commercial sale and distribution in the Territory for use in the Field exceeds twenty-five percent (25%) of IRC's Production for the Product, Trinity may request such additional amounts of the Product pursuant to the provisions of Section 6.4 below, and IRC, in its sole discretion, may decide to manufacture, sell and deliver to Trinity such additional amounts of the Product.

        1.4  Sections 6.3.1(a), (c) and (d) of the Agreement shall be deleted in their entirety and restated to read as follows:

            (a)  With respect to clinical development supply under Section 6.1.1 above, after receipt of approval from the governing health authority of Thailand to conduct the applicable human clinical trials in Thailand and approval from the FDA to supply the Product for use therein, IRC shall supply Trinity with such 100 microgram and DTH skin testing doses of the Product and placebo (as set forth in mutually acceptable protocols), for use in human clinical trials in Thailand under the Development Program for a period not to exceed three (3) years after the commencement of human clinical trials in Thailand. IRC shall supply such doses of Product and placebo for use in such human clinical trials in Thailand for not more than 10,000 enrolled patients during such period at no cost to Trinity. If additional Product and placebo is required for use in human clinical trials in Thailand prior to the First Commercial Sale, IRC shall supply such additional Product and placebo as the parties mutually agree in writing, at a purchase price equal to one hundred and ten percent (110%) of IRC's Manufacturing Cost for the Product and at such purchase price as the parties mutually agree in writing for placebo.

            (c)  With respect to commercial supply under Section 6.1.2 above, Trinity shall purchase Product from IRC at a price equal to one hundred and ten percent (110%) of IRC's Manufacturing Cost for such Product.

            (d)  IRC shall calculate its Manufacturing Cost for the Product in good faith in a manner which reasonably and equitably allocates the cost of Materials, Direct Labor and Benefits, Overhead, and Excess Capacity Related Cost (each as defined in Section 1.8 above) to the Product.

        1.5  Article 7 of the Agreement shall be deleted in its entirety.

2


        1.6  Article 8 of the Agreement shall be deleted in its entirety and restated to read as follows:


ARTICLE 8
REPORTS AND ACCOUNTING

            8.1  Reports, Exchange Rates. During the term of the Agreement following the First Commercial Sale of the Product, Trinity shall furnish to IRC a quarterly written report showing in reasonably specific detail, on a country by country basis, (a) the quantity of all Product sold or distributed by Trinity, its Affiliates and its sublicensees in the Territory during the reporting period; (b) the withholding taxes, if any, required by law with respect to such sale or distribution; and (c) the date of the First Commercial Sale of the Product in each country in the Territory during the reporting period. Reports shall be due on the thirtieth (30th) day following the close of each quarter. Trinity shall keep complete and accurate records in sufficient detail to properly reflect all sales and distributions of the Product.

            8.2  Audits for IRC

              8.2.1 Upon the written request of IRC and not more than twice in each calendar year, Trinity shall permit an independent certified public accounting firm of internationally recognized standing, selected by IRC and reasonably acceptable to Trinity, at IRC's expense, to have access during normal business hours to such records of Trinity as may be reasonably necessary to verify the accuracy of the reports hereunder for any year ending not more than thirty-six (36) months prior to the date of such request. The accounting firm shall disclose to IRC only whether the records are correct or not and the specific details concerning any discrepancies. No other information shall be shared.

              8.2.2 Trinity shall include in each permitted sublicense granted by it pursuant to the Agreement a provision requiring the sublicensee to make reports to Trinity, to keep and maintain records of sales and distributions made pursuant to such sublicense and to grant access to such records by IRC's independent accountant to the same extent required of Trinity under the Agreement.

            8.3  Audits for Trinity

              8.3.1 Upon the written request of Trinity and not more than twice in each calendar year, IRC shall permit an independent certified public accounting firm of internationally recognized standing, selected by Trinity and reasonably acceptable to IRC, at Trinity's expense, to have access during normal business hours to such records of IRC as may be reasonably necessary to verify the accuracy and the propriety of the amounts charged, consistent with Manufacturing Cost, of any invoices hereunder for any year ending not more than thirty-six (36) months prior to the date of such request. Trinity shall also have access to such records of IRC, under the same terms and conditions as provided for the audit of IRC's invoices to Trinity, as may be reasonably necessary to verify IRC's Production. The accounting firm shall disclose to Trinity only whether the records are correct or not and the specific details concerning any discrepancies. No other information shall be shared.

            8.4  Confidential Financial Information. Each party shall treat all of the other party's financial information subject to review under this Article 8 or under any sublicense agreement as confidential, and shall cause its accounting firm to retain all such financial information in confidence.

        1.6  Sections 9.1, 9.3, and 9.5 shall be deleted in its entirety.

3


        1.7  Section 11.2 of the Agreement shall be deleted in its entirety and restated to read as follows:

              Termination by IRC. This Agreement shall terminate, at the option of IRC effective upon written notice thereof to Trinity, if Trinity has not received the required marketing approval from the governing health authority of Thailand for the Product on or before August 31, 2004.


ARTICLE 2
MISCELLANEOUS

        2.1  Defined Terms. All terms used, but not defined, in this Amendment shall have the respective meanings set forth in the Agreement.

        2.2  Continuing Effect. This Amendment shall be effective for all purposes as of the Effective Date. Except as otherwise expressly modified by this Amendment, the Agreement shall remain in full force and effect in accordance with its terms.

        2.3  Governing Law. This Amendment shall be governed by and construed in accordance with the laws of the State of California, without regard to the conflicts of law, principles thereof, and shall not be governed by the United Nations Convention on Contracts for the International Sale of Goods.

        2.4  Counterparts. This Amendment may be executed in counterparts, each of which shall be deemed to be an original and together shall be deemed to be one and the same document.

        IN WITNESS WHEREOF, the undersigned have duly executed and delivered this Amendment effective as of the Effective Date.

    THE IMMUNE RESPONSE CORPORATION

 

 

By

 


Dennis J. Carlo, Ph. D.
President and Chief Executive Officer

 

 

TRINITY MEDICAL GROUP USA, INC.

 

 

By

 



 

 

Title

 



 

 

By

 



 

 

Title

 


4




QuickLinks

AMENDMENT NO. 2 TO LICENSE AND COLLABORATION AGREEMENT
RECITALS
ARTICLE 1 AMENDMENT
ARTICLE 8 REPORTS AND ACCOUNTING
ARTICLE 2 MISCELLANEOUS
EX-10.6 5 a2083790zex-10_6.htm EXHIBIT 10.6
QuickLinks -- Click here to rapidly navigate through this document


Exhibit 10.6


AMENDMENT NO. 1 TO STOCK PURCHASE AGREEMENT

        THIS AMENDMENT NO. 1 TO STOCK PURCHASE AGREEMENT (this "Amendment"), effective as of June 26, 2002 (the "Effective Date") is entered into by and between THE IMMUNE RESPONSE CORPORATION, a Delaware corporation (the "Company"), and TRINITY MEDICAL GROUP USA, INC., a Florida corporation (the "Investor"), with respect to the following facts.

RECITALS

        A.    IRC and Trinity Medical Group, Co., Ltd., a Thai limited company ("Trinity Thailand"), entered into the Stock Purchase Agreement dated as of September 15, 1995 (the "Agreement").

        B.    Pursuant to the Assignment Agreement dated as of August 3, 2000, between Trinity Thailand and the Investor, Trinity Thailand assigned to the Investor and the Investor assumed, all of Trinity Thailand's rights and obligations under the Agreement.

        C.    The parties now desire to amend the Agreement on the terms and conditions set forth below.

        NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants set forth below, the parties amend the Agreement and otherwise agree as follows:

ARTICLE 1
AMENDMENT

        1.1  Section 1.1 of the Agreement is restated in its entirety to read as follows:

            1.1    Sale and Issuance of Shares.    On the terms and subject to the conditions of the Agreement, the Investor shall purchase, and the Company shall sell and issue to the Investor, the following number of shares (the "Shares") of the Company's common stock on the following dates (each a "Closing Date") at the following purchase price (the "Purchase Price"):

              1.1.1    The Investor shall purchase, and the Company shall sell and issue to the Investor, 333,334 Shares at the Purchase Price of US$15.00 per share, on April 30, 1996 (the "First Closing Date"); and

              1.1.2    The Investor shall purchase, and the Company shall sell and issue to the Investor, 2,000,000 Shares at the Purchase Price of US$2.50 per share, on the date that is thirty (30) days after the date on which the Investor receives the required marketing approval from the governing health authority of Thailand for the Product (the "Second Closing Date").

            1.2    Section 2.10 of the Agreement is restated in its entirety to read as follows:

              2.10    The Company (a) is a "domestic issuer" and a "reporting issuer" (as such terms are defined in Rule 902 of Regulation S), and (b) has filed all material required to be filed by it pursuant to the requirements of Section 13(a) or 15(d) of the 1934 Act for at least the twelve (12) months immediately preceding the date hereof. The Common Stock trades on the Nasdaq Stock Market.

ARTICLE 2
REGISTRATION RIGHTS

        2.1  At the request of the Investor, the Company agrees to file a registration statement under the Securities Act of 1933, as amended (the "Act"), with the Securities and Exchange Commission ("SEC") to register the Shares issued pursuant to Section 1.1.2 of the Agreement (as amended hereby), as soon

1


as practicable after the Second Closing Date and upon receipt of the request of the Investor. The Company shall use reasonable commercial efforts to respond to comments of the SEC within ten (10) business days of receipt of said comments and will use commercially reasonable efforts to cause the registration statement to be declared effective by the SEC within ninety (90) days of the receipt of the request from the Investor. The Company shall keep the registration statement continuously effective until the date occurring one year following the date on which the Shares were issued to the Investor pursuant to Section 1.1.2 of the Agreement (as amended hereby). The Company shall cause the related prospectus to be amended or supplemented by a required prospectus supplement pursuant to Rule 424 under the Act. Notwithstanding the foregoing, the Company may delay the filing of the registration statement for 180 days after receipt of the request from the Investor, if it furnishes to the Investor a certificate signed by the Chairman of the Board of Directors of the Company stating, that in the good faith judgment of the Board of Directors of the Company, it would be seriously detrimental to the Company and its stockholders for such registration statement to be filed and that it is therefore, essential to delay the filing of the registration statement.

        2.2  In addition, the Company hereby grants to the Investor piggyback registration rights with respect to the Shares issued to the Investor pursuant to Section 1.1.2 of the Agreement (as amended hereby) as set forth below. In the event the Company is filing a registration statement for itself or on behalf of any of its stockholders, the Company shall notify the Investor in writing reasonably in advance of such filing (but at least five business days) and give the Investor the opportunity to include all or any part of such Shares in the registration statement. If a registration statement under which the Company gives notice under this Article 2.2 is for an underwritten offering, then the Company shall so advise the Investor in the notice. In such event, the right of the Investor to include any of such Shares in a registration pursuant to this Article 2.2 shall be conditioned upon the Investor's participation in such underwriting. The Investor shall enter into an underwriting agreement in customary form with the managing underwriter or underwriter(s) selected for such underwriting. Notwithstanding any other provision of this Article 2.2, if the underwriter(s) determine(s) in good faith that market factors require a limitation of the number of shares to be underwritten, then the underwriter(s) may exclude shares from the registration and the underwriting, and the number of shares that may be included in the registration and the underwriting shall be allocated, first, to the Company, and second, on a pro rata basis, amongst the Shares issued to the Investor pursuant to Section 1.1.2 of the Agreement (as amended hereby) and any shares held by other stockholders of the Company who have piggyback registration rights.

ARTICLE 3
MISCELLANEOUS

        3.1  All terms used, but not defined, in this Amendment shall have the respective meanings set forth in the Agreement.

        3.2  This Amendment shall be effective for all purposes as of the Effective Date. Except as otherwise expressly modified by this Amendment, the Agreement shall remain in full force and effect in accordance with its terms.

        3.3  This Amendment shall be governed by, interpreted and construed in accordance with the laws of the State of California, without regard to conflict of law principles.

        3.4  This Amendment may be executed in counterparts, each of which shall be deemed to be an original and together shall be deemed to be one and the same document.

2



        IN WITNESS WHEREOF, the parties have caused this Amendment to be executed by their respective duly authorized officers as of the Effective Date.

    THE IMMUNE RESPONSE CORPORATION

 

 

By

 

 
       
Dr. Dennis J. Carlo
President and CEO

 

 

TRINITY MEDICAL GROUP USA, INC.

 

 

By

 

 
       
President

 

 

By

 

 
       
Chief Executive Officer

3




QuickLinks

AMENDMENT NO. 1 TO STOCK PURCHASE AGREEMENT
-----END PRIVACY-ENHANCED MESSAGE-----