Document:

Exhibit 10.9 U of T Agreement

EXCLUSIVE PATENT AND TECHNOLOGY LICENSE AGREEMENT BETWEEN THE UNIVERSITY OF TEXAS SYSTEM 

AND 

DOR VACCINES, INC. 

This Patent and Technology License Agreement (the AGREEMENT) is made between the Board of Regents (BOARD) of the University of Texas System (SYSTEM), an agency of the State of Texas, whose address is 201 West 7th Street, Austin, Texas 78701, on behalf of The University of Texas Southwestern Medical Center at Dallas (UT SOUTHWESTERN), a component institution of SYSTEM, and DOR Vaccines, Inc. (LICENSEE) , an Delaware corporation, with its principal place of business at 28101 Ballard Drive, Lake Forest, Illinois 60045. 

RECITALS 

A. BOARD owns certain PATENT RIGHTS (as defined below) and TECHNOLOGY RIGHTS (as defined below) related to LICENSED SUBJECT MATTER (as defined below), which were developed at UT SOUTHWESTERN. 

B. BOARD desires to have the LICENSED SUBJECT MATTER developed and used for the benefit of LICENSEE, INVENTORS (as defined below), BOARD, and the public as outlined in BOARD'S Intellectual Property Policy. 

C. LICENSEE wishes to obtain a license from BOARD to practice LICENSED SUBJECT MATTER. 

D. LICENSEE is a wholly owned subsidiary of DOR BioPharma, Inc. 

NOW, THEREFORE, in consideration of the mutual covenants and premises herein contained, the parties agree as follows: 

1. EFFECTIVE DATE 

This AGREEMENT is effective as of June 30, 2003 (EFFECTIVE DATE). 

2. DEFINITIONS 

As used in this AGREEMENT, the following terms have the meanings indicated: 

2.1    AFFILIATE means any business entity more than 50% owned by LICENSEE, any business entity which owns more than 50% of LICENSEE, or any business entity that is more than 50% owned by a business entity that owns more than 50% of LICENSEE. 

 

2.2 BLA means a Biological License Application filed with the PDA (as defined below) or the equivalent application with regulatory authorities in other countries. 

2.3 FDA means United States Food and Drug Administration. 

2.4 FIELD means all formulations of ricin vaccines, specifically excluding oral, nasal, and inhalation formulations. 

2.5 INVENTORS mean Roxana G. Baluna, Victor F. Ghetie, Joan E. Smallshaw, and Ellen S. Vitetta. 

2.6 LICENSED PRODUCT means any product or service which is covered by or is produced using LICENSED SUBJECT MATTER pursuant to this AGREEMENT, 

2.7 LICENSED SUBJECT MATTER means inventions, discoveries and processes covered by PATENT RIGHTS or TECHNOLOGY RIGHTS within FIELD. 

2.8 NDA means New Drug Application filed with the FDA or the equivalent application filed with regulatory authorities in other countries. 

2.9 NET SALES means the gross revenues received by LICENSEE, AFFILIATE and/or any sublicensee pursuant to Paragraph 4.3 from the SALE of LICENSED PRODUCTS less sales and/or use taxes actually paid, import and/or export duties actually paid, outbound transportation prepaid or allowed, and amounts allowed or credited due to returns (not to exceed the original billing or invoice amount). 

2.10 PATENT RIGHTS mean BOARD'S rights in information or discoveries covered by U.S. Patent No. 6,566,500 (UT SOUTHWESTERN file reference number UTSD:0603 US) and the letters patents that issue from U.S. Patent Application No. 09/668,419 (UT SOUTHWESTERN file reference number UTSD:0723 US), U.S. Patent Application No. 09/698,551 (UT SOUTHWESTERN file reference number UTSD:0723 US CIP1), and U.S. Patent Application No. 10/282,935 (UT SOUTHWESTERN file reference number UTSD:0884 US) and all subsequent divisionals, continuations, reissues, reexeaminations or extensions that claim priority therefrom, and any corresponding foreign patents and patent applications. 

2.1 1 REGULATORY APPROVAL means FDA approval of an NDA or BLA to market a new drug in the United States or an equivalent approval milestone in any national jurisdiction. 

2.12 SALE, SELL or SOLD means the transfer or disposition of a LICENSED PRODUCT for value to a party other than LICENSEE. 

2.13 TECHNOLOGY RIGHTS mean BOARD'S rights in any technical information, know- how, processes, procedures, compositions, methods, formulae, protocols, techniques or data developed by INVENTORS at UT SOUTHWESTERN prior to the EFFECTIVE DATE relating to ricin vaccine formulation(s) which are not covered by PATENT RIGHTS, but which are necessary for practicing the invention covered by PATENT RIGHTS. 

 

3. WARRANTY: SUPERIOR-RIGHTS 

3. 1 Except for the rights, if any, of the government of the United States of America (GOVERNMENT), as set forth below, BOARD represents and warrants (1) that it is the owner of the entire right, title, and interest in and to LICENSED SUBJECT MATTER, (2) that it has the sole right to grant licenses thereunder, and (3) its belief that it has not knowingly granted licenses thereunder to any other entity that would restrict rights granted to LICENSEE except as stated herein. 

3.2 LICENSEE understands that the LICENSED SUBJECT MATTER may have been developed under a funding agreement with the GOVERNMENT and, if so, that the GOVERNMENT may have certain rights relative thereto. This AGREEMENT is explicitly made subject to the GOVERNMENT'S rights under any agreement and any applicable law or regulation. If there is a conflict between any agreement, applicable law or regulation and this AGREEMENT, the terms of the GOVERNMENT agreement, applicable law or regulation shall prevail. LICENSEE agrees that LICENSED PRODUCTS used or SOLD in the United States will be manufactured substantially in the United States, unless a written waiver is obtained in advance from the GOVERNMENT. 

3.3 LICENSEE understands and acknowledges that BOARD, by this AGREEMENT, makes no representation as to the operability or fitness for any use, safety, efficacy, approvability by regulatory authorities, time and cost of development, patentability, and/or breadth of the LICENSED SUBJECT MATTER. BOARD, by this AGREEMENT, also makes no representation as to whether there are any patents now held, or which will be held, by others or by BOARD which may be dominant or subordinate to PATENT RIGHTS, nor does BOARD make any representation that the inventions contained in PATENT RIGHTS do not infringe any other patents now held or that will be held by others or by BOARD. 

3.4 LICENSEE, by execution hereof, acknowledges, covenants and agrees that it has not been induced in any way by BOARD, SYSTEM, UT SOUTHWESTERN or its employees to enter into this AGREEMENT, and further warrants and represents that (1) it has conducted sufficient due diligence with respect to all items and issues pertaining to this AGREEMENT and all other matters pertaining to this AGREEMENT; and (2) LICENSEE has adequate knowledge and expertise, or has utilized knowledgeable and expert consultants, to adequately conduct the due diligence, and agrees to accept all risks inherent herein. 

4. LICENSE 

4.1 BOARD hereby grants to LICENSEE a worldwide, royalty-bearing, exclusive license under LICENSED SUBJECT MATTER to manufacture, have manufactured, use and/or SELL LICENSED PRODUCTS for use within FIELD. This grant is subject to the payment by LICENSEE to BOARD of all consideration as provided herein, and is further subject to rights retained by BOARD to: 

a.
    publish the general scientific findings from research related to 
LICENSED
SUBJECT MATTER subject to the terms of Article 13, Confidential Information;

b. use LICENSED SUBJECT MATTER for research, teaching and other educationally-related purposes; and 

c. transfer LICENSED SUBJECT MATTER to academic or research institutions for non- commercial research use. 

4.2 LICENSEE may extend the license granted herein to any AFFILIATE if the AFFILIATE consents in writing to be bound by this AGREEMENT to the same extent as LICENSEE. LICENSEE must deliver to BOARD a true and accurate copy of such written agreement, and any modification or termination thereof, within 30 days after execution, modification or termination. 

4.3 LICENSEE may grant sublicenses consistent with this AGREEMENT if LICENSEE is responsible for the operations of its sublicensees relevant to this AGREEMENT as if the operations were carried out by LICENSEE, including the payment of royalties whether or not paid to LICENSEE by a sublicensee. LICENSEE must deliver to BOARD a true and correct copy of each sublicense granted by LICENSEE, and any modification or termination thereof, within 30 days after execution, modification, or termination. When this AGREEMENT is terminated, BOARD and UT SOUTHWESTERN agree to accept as successors to LICENSEE existing sublicensees in good standing at the date of termination, provided that the sublicensees consent in writing to be bound by all the terms and conditions of this AGREEMENT. 

5. PAYMENTS AND REPORTS 

5.1 In consideration of rights granted by BOARD to LICENSEE under this AGREEMENT, LICENSEE will pay BOARD the following: 

a. equity as described in Article 6; and 

b. a non-refundable up-front license fee in the amount of $200,000, due and payable according to the schedule below: 

	
Due Date 

 
	
Amount 

 

	

	

	
12 months from the EFFECTIVE DATE 

 
	
$100,000 

 

	

	

	
18 months from the EFFECTIVE DATE 

 
	
$100,000 

 

	

	

c.
    a minimum yearly royalty of $50,000 due and payable on January 1 of each year
beginning January 1, 2005 and creditable against royalties due under 5.Id for that year;
and

d.
    a running royalty equal to 7.0% of NET SALES, provided however, for any
periods where LICENSEE is required to pay a royalty to a third party for the right to
carry out such a SALE, said running royalty shall be reduced in an amount equal to 1⁄2 of
any such royalty actually paid, to a rate of no less than 5.5% of NET SALES of any such LICENSED PRODUCT; and

e. milestone fees according to the table below, due and payable within 30 days of each milestone event: 

	
Milestone Event 

 
	
Milestone Fee 

 

	

	

	
Initiation of manufacture of first LICENSED PRODUCTS to be for SALE 

 
	
$100,000 

 

	

	

	
Filing NDA or BLA 

 
	
$250,000 

 

	

	

	
REGULATORY APPROVAL 

 
	
$500,000 

 

	

	

f.
    a sublicense fee of 20% of all consideration, other than royalties on NET SALES
and research and development money, received by LICENSEE from either (1) any
sublicensee pursuant to Paragraph 4.3 above, or (2) any assignee pursuant to Article 9
below, including but not limited to, up-front payments, marketing, distribution, franchise,
option, license, or documentation fees, bonus and milestone payments and equity
securities within 30 days of LICENSEE'S receipt of any such consideration. The value
of any equity securities will be calculated as the average market value of the class of
stock involved for 5 consecutive days preceding the transfer to LICENSEE; and

g. expenses paid by UT SOUTHWESTERN after the EFFECTIVE DATE for filing, prosecuting, enforcing, and maintaining PATENT RIGHTS for so long as, and in such countries, as this AGREEMENT remains in effect. UT SOUTHWESTERN will invoice LICENSEE on a periodic basis for expenses paid by UT SOUTHWESTERN after the EFFECTIVE DATE. The invoiced amounts will be due and payable by LICENSEE within 30 days. 

5.2 In the event of late payments to BOARD due under Article 5, a penalty of 10% of the amount due will be assessed and due additionally from LICENSEE for each such late payment. 

5.3 During the term of this AGREEMENT and for 1 year thereafter, LICENSEE agrees to keep complete and accurate records of its and its sublicensees' SALES and NET SALES under the license granted in this AGREEMENT in sufficient detail to enable the royalties payable hereunder to be determined. LICENSEE agrees to permit BOARD or its representatives, at BOARD'S expense and with 14 days written notice, to periodically examine its books, ledgers, and records during regular business hours for the purpose of and to the extent necessary to verify any report required under this AGREEMENT. If the amounts due to BOARD are determined to have been underpaid, LICENSEE will pay the cost of the examination and all overdue amounts with accrued interest at the highest allowable rate. 

5.4 Within 30 days after March 31, June 30, September 30, and December 31 of each year of the valid term of this* AGREEMENT, beginning immediately after the EFFECTIVE DATE, LICENSEE must deliver to BOARD a true and accurate written report, even if no payments are due BOARD, giving the particulars of the business conducted by LICENSEE and its sublicensee(s), if any exist, during the preceding 3 calendar months under this AGREEMENT as are pertinent to calculating payments hereunder. Such reports will be on a per-country and per-product basis and presented substantially in the form as shown in Exhibit 1. Simultaneously with the delivery of each report, LICENSEE must pay to BOARD the amount due, if any, for the period of each report. 

5.5 On or before each anniversary of the EFFECTIVE DATE, irrespective of having a first SALE or offer for SALE, LICENSEE must deliver to BOARD a written progress report as to LICENSEE'S (and any sublicensee's) efforts and accomplishments during the preceding year in diligently commercializing LICENSED SUBJECT MATTER and LICENSEE'S (and sublicensee's) commercialization plans for the upcoming year. 

5.6 All amounts payable here by LICENSEE must be paid in United States dollars without deductions for taxes, assessments, fees, or charges of any kind. Royalties accruing on SALES in countries other than the United States must be paid in United States dollars in amounts based on the rate of exchange as quoted in the Wall Street Journal (WSJ) as of the last business day of the reporting period. If the WSJ does not publish any such rate, a comparable rate publication will be agreed upon from time to time by the parties, and with respect to each country for which such rate is not published by the WSJ or in a comparable publication, the parties will use the prevailing rate for bank cable transfers for such date, as quoted by leading United States banks in New York City dealing in the foreign exchange market. 

5.7 All payments must be payable to UT SOUTHWESTERN and sent to the address listed in Paragraph 15.2. 

6. EQUITY OWNERSHIP 

6.1 LICENSEE will issue to BOARD a number of shares of unregistered common stock of DOR BioPharma, Inc., par value $.001 per share, which will have a market value equal to $200,000 based on its average closing price of the previous 15 trading days immediately preceding the EFFECTIVE DATE (SHARES). 

6.2 LICENSEE will register all of the SHARES issued to BOARD in a registration statement on Forms S-l, S-2 or S-3 (or any successors thereto) with the United States Securities and Exchange Commission (SEC) within 180 days of the EFFECTIVE DATE. If the average closing price for DOR BioPharma, Inc.'s common stock from the 15 trading days previous to the day on which the registration statement is filed is less than the price at which SHARES were issued, LICENSEE will issue additional shares of DOR BioPharma, Inc.'s common stock to BOARD (ADDITIONAL SHARES). The collective market value of the SHARES and ADDITIONAL SHARES will be equal to $200,000 based on such closing price. 

6.3 LICENSEE will issue SHARES within 30 days of the EFFECTIVE DATE and ADDITIONAL SHARES, if any, within five days following the applicable trading day. SHARES and ADDITIONAL SHARES, if any, will be issued in the names and proportions as described in Exhibit 2. 

6.4 LICENSEE represents and warrants that the SHARES and ADDITIONAL SHARES (if any) have been duly and validly authorized and reserved for issuance and, when issued to BOARD in accordance with this AGREEMENT, will be validly issued, fully paid and non­ assessable, free and clear of all encumbrances affecting title, and will conform to the description of the common stock of DOR BioPharma, Inc. contained in the required reports, schedules, forms, statements and other documents filed with the SEC. None of the transactions contemplated by this AGREEMENT will violate or result in a violation of the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, or blue sky laws. 

6.5 LICENSEE further represents and warrants that LICENSEE has the authorized capitalization set forth in the required reports, schedules, forms, statements and other documents filed with the SEC, and all issued shares of capital stock of LICENSEE have been duly and validly authorized and issued, and are fully paid and non-assessable. No vote or consent, including, without limitation, the vote or consent of LICENSEE'S stockholders and lenders, is required to approve this AGREEMENT or for LICENSEE to consummate the transactions and perform its obligations contemplated hereby. 

7. TERM AND TERMINATION 

7.1 The term of this AGREEMENT is from the EFFECTIVE DATE to the later of (a) the full end of the term or terms for which PATENT RIGHTS have not expired or (b) 20 years if LICENSED PRODUCTS are covered solely by TECHNOLOGY RIGHTS. 

7.2 Any time after 1 year from the EFFECTIVE DATE, BOARD and UT SOUTHWESTERN have the right to terminate this license in any national political jurisdiction if LICENSEE, within 90 days after receiving written notice from UT SOUTHWESTERN of the intended termination, fails to provide written evidence satisfactory to UT SOUTHWESTERN that LICENSEE or its sublicensee(s) has: 

a. SALES in such jurisdiction; or 

b. an effective, ongoing and active research, development, manufacturing, marketing or sales program as appropriate, directed toward obtaining regulatory approval, and/or production and/or SALES in any jurisdiction in accordance with LICENSEE'S business, legal, medical and scientific judgment and LICENSEE'S normal practices and procedures for products having similar technical and commercial potential. 

7.3 This AGREEMENT will earlier terminate: 

a.  automatically if LICENSEE becomes bankrupt and/or if the business of LICENSEE is placed in the hands of a receiver, assignee, or trustee, whether by voluntary act of LICENSEE or otherwise; or 

b.  upon 7 days written notice from BOARD if LICENSEE becomes insolvent unless, before the end of the 7 day period, LICENSEE provides BOARD with evidence of its solvency; or

c.  upon 30 days written notice from BOARD if LICENSEE breaches or defaults on its obligation to make payments (if any are due) or reports, in accordance with the terms of Article 5 hereunder, unless, before the end of the 30 day period, LICENSEE has cured the breach or default and so notifies BOARD, stating the manner of the cure; or

d. upon 90 days written notice if LICENSEE breaches or defaults on any other obligation under this AGREEMENT, unless, before the end of the 90 day period, LICENSEE has cured the breach or default and so notifies BOARD, stating the manner of the cure; or 

e.  at any time by mutual written agreement between LICENSEE, UT SOUTHWESTERN and BOARD, upon 30 days written notice to all parties and subject to any terms herein which survive termination; or

f  under the provisions of Paragraph 7.2 if invoked.

 

7.4 If this AGREEMENT is terminated for any cause:

a.  nothing herein will be construed to release either party of any obligation matured prior to the effective date of the termination;

b.  after the effective date of the termination, LICENSEE will provide BOARD with a written inventory of all LICENSED PRODUCTS in process of manufacture, in use or in stock. LICENSEE may SELL any such LICENSED PRODUCTS within the 90 day period following such termination if it pays earned royalties thereon, and any other amount due pursuant to the terms of Article 5; and

c. LICENSEE will be bound by the provisions of Articles 11 (Indemnification), 12 (Use Of Name), and 13 (Confidential Information) of this AGREEMENT.

8. INFRINGEMENT BY THIRD PARTIES 

8.1 LICENSEE, at its expense, must enforce PATENT RIGHTS against infringement in the FIELD by third parties and is entitled to retain recovery from such enforcement. Any recovery for damages and/or a reasonable royalty in lieu thereof will be considered NET SALES and subject to royalty payment pursuant to Paragraph 5. Id. If LICENSEE does not file suit against a substantial infringer of PATENT RIGHTS within 6 months of knowledge thereof, then BOARD may enforce PATENT RIGHTS on behalf of itself and LICENSEE, BOARD retaining all recoveries from such enforcement and/or reducing the license granted hereunder to non­ exclusive. 

8.2 In any infringement suit or dispute, the parties agree to cooperate fully with each other. At the request and expense of the party bringing suit, the other party will permit access to all relevant personnel, records, papers, information, samples, specimens, etc., during regular business hours. 

9. ASSIGNMENT 

Except in connection with the sale of substantially all of LICENSEE'S assets to a third party, this AGREEMENT may not be assigned by LICENSEE without the prior written consent of BOARD, which will not be unreasonably withheld. The LICENSEE may assign this AGREEMENT and the rights hereunder to an AFFILIATE of the LICENSEE. 

 

10. PATENT MARKING 

LICENSEE must permanently and legibly mark all products, packaging and documentation manufactured or SOLD by it under this AGREEMENT with a patent notice as may be permitted or required under Title 35, United States Code. 

11. INDEMNIFICATION 

LICENSEE agrees to hold harmless and indemnify BOARD, INVENTORS, SYSTEM, UT SOUTHWESTERN, its Regents, officers, employees and agents from and against any claims, demands, or causes of action whatsoever, including without limitation those arising on account of any injury or death of persons or damage to property caused by, or arising out of, or resulting from, the exercise or practice of the license granted hereunder by LICENSEE, its AFFILIATES or their officers, employees, agents or representatives. 

12. USE OF NAME 

LICENSEE may not use the name of UT SOUTHWESTERN, SYSTEM, INVENTORS or BOARD without express written consent from UT SOUTHWESTERN and/or SYSTEM except as required by governmental law, rule or regulation. Consent should be requested in writing at least 5 business days in advance and sent to: 

Roy Bode 

Vice President for Public Affairs 

UT Southwestern Medical Center at Dallas 

5323 Harry Hines Blvd. 

Dallas, Texas 75390-8588 

Email: Roy.Bode@UTSouthwestem.edu 

Phone: 214-648-7500 

Fax: 214-648-7503 

13. CONFIDENTIAL INFORMATION 

13.1 BOARD and LICENSEE each agree that all information forwarded to one by the other for the purposes of this AGREEMENT (1) are to be received in strict confidence, (2) are to be used only for the purposes of this AGREEMENT, and (3) are not to be disclosed by the recipient party, its agents or employees without the prior written consent of the other party, except to the extent that the recipient party can establish competent written proof that such information: 

a. was in the public domain at the time of disclosure; 

b. later became part of the public domain through no act or omission of the recipient party, its employees, agents, successors or assigns; 

c. was lawfully disclosed to the recipient party by a third party having the right to disclose it; 

d. was already known by the recipient party at the time of disclosure; 

e. was independently developed by the recipient; or 

f. is required by law or regulation to be disclosed, provided however,  that the disclosing party shall first give the other party written notice and adequate opportunity to object to such order for disclosure or to request confidential treatment.

13.2 Information shall not be deemed to be available to the public or to be in the recipient's possession merely because it: 

a,  includes information that falls within an area of general knowledge available to the public or to the recipient (i.e., it does not include the specific information provided by the other party); or

b. can be reconstructed in hindsight from a combination of information from multiple sources that are available to the public or to the recipient, if not one of those sources actually taught or suggested the entire combination, together with its meaning and importance.

13.3 Each party's obligation of confidence hereunder shall be fulfilled by using at least the same degree of care with the other party's confidential information as it uses to protect its own confidential information. This obligation shall exist while this AGREEMENT is in force and for a period of 3 years thereafter. 

14. PATENTS AND INVENTIONS 

If, after consultation with LICENSEE, both parties agree that a patent application should be filed for LICENSED SUBJECT MATTER, BOARD will prepare and file the appropriate patent application, and LICENSEE will pay the cost of searching, preparing, filing, prosecuting and maintaining same and this application will be considered PATENT RIGHTS. If LICENSEE notifies BOARD that it does not intend to pay such costs, or if LICENSEE does not respond or make an effort to agree with BOARD on the disposition of rights in the subject invention, then BOARD may file an application at its own expense and LICENSEE will have no rights to such invention. BOARD shall retain the sole right to select the attorney responsible for filing, prosecution and maintenance of any patents based on technology invented at UT SOUTHWESTERN. BOARD will provide LICENSEE a copy of any patent application for which LICENSEE has paid the cost of filing, as well as copies of any documents received or filed with the respective patent office during the prosecution thereof. 

15. GENERAL 

15.1 This AGREEMENT constitutes the entire and only agreement between the parties for LICENSED SUBJECT MATTER and all other prior negotiations, representations, agreements, and understandings are superseded hereby. No agreements altering or supplementing the terms hereof may be made except by a written document signed by both parties. 

15.2 Any payments required by this AGREEMENT must be payable to UT SOUTHWESTERN and sent to: 

 

UT Southwestern Medical Center at Dallas 

Office for Technology Development 

5323 Harry Hines Boulevard 

Dallas, Texas 75390-9094 

ATTENTION: Director for Technology Transfer 

15.3 Any notice required by this AGREEMENT must be given by email or facsimile transmission confirmed by personal delivery (including delivery by reputable messenger services such as Federal Express) or by prepaid, first class, certified mail, return receipt requested, addressed in the case of BOARD and UT SOUTHWESTERN to: 

UT Southwestern Medical Center at Dallas 

Office for Technology Development 

5323 Harry Hines Boulevard 

Dallas, Texas 75390-9094 

ATTENTION: Director for Technology Transfer 

Email: TechnologyDeveloprnent@UTSouthwestern.edu 

Phone: (214)648-1888 

Fax: (214)648-1889 

with copies to: 

Board of Regents 

The University of Texas System 

201 West 7 th Street 

Austin, Texas 78701 

ATTENTION: Office of General Counsel 

Email: gharper@utsystem.edu or bmaxwell@utsystem.edu 

Phone: (512)499-4462 

Fax: (512)499-4523 

or in the case of LICENSEE to: 

DOR Vaccines, Inc. 

Attn: William Milling, Controller 

28101 Ballard Drive 

Lake Forest, IL 60045 

Email: wmilling@dorbiopharma.com 

Phone: 847-573-8990 

Fax: 847-573-9285 

or other addresses as may be given from time to time under the terms of this notice provision. 

15.4 LICENSEE must comply with all applicable national, state and local laws and regulations in connection with its activities pursuant to this AGREEMENT. 

15.5 This AGREEMENT will be construed and enforced in accordance with the laws of the United States of America and of the State of Texas. The Texas state courts of Dallas County, Texas (or, if there is exclusive federal jurisdiction, the United States District Court for the Northern District of Texas) shall have exclusive jurisdiction and venue over any dispute arising out of this AGREEMENT, and LICENSEE hereby consents to the jurisdiction of such courts. 

15.6 Failure of BOARD to enforce a right under this AGREEMENT will not act as a waiver of that right or the ability to later assert that right relative to the particular situation involved. 

15.7 Headings are included herein for convenience only and shall not be used to construe this AGREEMENT. 

15.8 If any part of this AGREEMENT is for any reason found to be unenforceable, all other parts nevertheless remain enforceable. 

15.9 Neither party shall be held liable or responsible to the other party nor be deemed to have defaulted under or breached this AGREEMENT for failure or delay in fulfilling or performing any term of this AGREEMENT when such failure or delay is caused by or results from causes beyond the reasonable control of the affected party, including, without limitation, fire, floods, earthquakes, natural disasters, embargoes, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, acts of God or acts, omissions or delays in acting by any governmental authority or the other party. 

The remainder of this page remains intentionally blank. 

 

IN WITNESS

WHEREOF, 
parties hereto have caused their duly authorized representatives to
execute this AGREEMENT.

BOARD OF REGENTS OF THE UNIVERSITY OF TEXAS SYSTEM 

By _/s/John A. Roan ______________________ 

John A. Roan 

Exe cutive Vice President for Business Affairs 

UT Southwestern Medical Center at Dallas 

Date_______________ 

DOR VACCINES, INC. 

By _/s/Ralph Ellison ____________________ 

Ralph Ellison 

CEO and President 

Date_ 3 July 2003 ______________ 

Approved as to Content: 

By _/s/Dennis K. Stone, M.D._______________ 

Dennis K. Stone, M.D. 

Vice President for Technology Development 

UT Southwestern Medical Center at Dallas 

Date __4 June 2003______Exhibit 4.20
                                                                    ------------

                               EIGHTH AMENDMENT TO
                AMENDED AND RESTATED LOAN AND SECURITY AGREEMENT

         THIS EIGHTH AMENDMENT TO AMENDED AND RESTATED LOAN AND SECURITY
AGREEMENT is dated as of December 1, 2003 (this "Eighth Amendment"), by and
among WELLS FARGO FOOTHILL, INC. ("Lender"), assignee of Bank of America, N.A.,
ELXSI, a California corporation ("ELXSI"), BICKFORD'S HOLDINGS COMPANY, INC., a
Delaware corporation ("Holdings"), and BICKFORD'S FAMILY RESTAURANTS, INC., a
Delaware corporation ("Bickford's" and collectively with ELXSI and Holdings, the
"Borrowers").

                                   WITNESSETH:

         WHEREAS, Borrowers and Lender (or Lender's predecessor in interest)
entered into that certain Amended and Restated Loan and Security Agreement,
dated as of April 22, 2002, as amended by that certain First Amendment to
Amended and Restated Loan and Security Agreement dated as of August 5, 2002,
that certain Second Amendment to Amended and Restated Loan and Security
Agreement dated as of December 30, 2002, that certain Third Amendment to Amended
and Restated Loan and Security Agreement dated as of January 31, 2003, that
certain Fourth Amendment to Amended and Restated Loan and Security Agreement
dated as of March 31, 2003, that certain Fifth Amendment to Amended and Restated
Loan and Security Agreement dated as of June 30, 2003 (the "Fifth Amendment"),
that certain Sixth Amendment to Amended and Restated Loan and Security Agreement
dated as of August 29, 2003, and that certain Amended and Restated Seventh
Amendment to Amended and Restated Loan and Security Agreement dated as of
September 30, 2003 (as amended, restated, supplemented or otherwise modified
through the date hereof, the "Loan Agreement");

         WHEREAS, on June 18, 2003, Bank of America, N.A., assigned all of its
right, title and interest in and to the Loan Agreement and Related Agreements
(as defined in the Loan Agreement) and Supplemental Documentation (as defined in
the Loan Agreement) to Lender; and

         WHEREAS, Borrowers have requested that the Lender consent to certain
amendments of the Loan Agreement as more fully set forth herein;

         NOW THEREFORE, in consideration of the premises and of the mutual
covenants contained herein, and other good and valuable consideration, the
receipt and adequacy of which are hereby acknowledged, the parties hereto agree
as follows:

         SECTION 1. Defined Terms. Unless otherwise defined herein, all
capitalized terms used herein have the meanings assigned to such terms in the
Loan Agreement, as amended hereby.

         SECTION 2. Amendments. Upon the Eighth Amendment Effective Date (as
hereinafter defined), the Loan Agreement shall be amended as follows:

                                       1
<PAGE>

         (a) The last sentence of the definition of "Note" in Section 1.1 shall
be deleted in its entirety and replaced with the following: "Notwithstanding the
terms and provisions of the Notes, each of the Notes shall be deemed amended
hereby to provide for a maturity date of January 15, 2004."

         (b) The following definitions in Section 1.1 of the Loan Agreement are
hereby deleted in their entirety and replaced with the following:

         "'Revolving Loan Availability' means on any date of determination, (a)
the lesser of (i) the Revolving Credit Amount minus the Letter of Credit
Obligations on such date, and (ii) 3.3 times EBITDA (as defined on Supplement A)
for the twelve-month period ending on the last day of the month immediately
preceding the date that is thirty days prior to such date of determination,
minus (b) the Reserved Amount on such date.

         "'Termination Date' means January 15, 2004."

         (c) The following definition is hereby added to Section 1.1 of the Loan
Agreement to be placed in a manner that maintains alphabetical order:

         "'Reserved Amount' means the aggregate reserves established from time
to time, in such amounts, and with respect to such matters, as Lender in its
reasonable discretion shall deem necessary and appropriate, including reserves
with respect to (i) sums that any Borrower is required to pay under any section
of this Agreement or any other Loan Document (such as taxes, assessments,
insurance premiums, or, in the case of leased assets, rents or other amounts
payable under such leases) and has failed to pay timely, (ii) amounts owing by
any Borrower to any Person to the extent secured by a Lien on any of the
Collateral (other than any existing permitted Lien which Lien, in the reasonable
discretion of Lender, would likely have a priority superior to Lender's liens
(such as Liens in favor of landlords, warehousemen, carriers, mechanics,
materialmen, laborers, or suppliers or Liens for ad valorem, excise, sales or
other taxes where given priority under applicable law) in and to such item of
the Collateral), and (iii) reserves established on or after December 31, 2003,
in the event any of the following actions has not been completed by December 31,
2003: (A) each Depository Account with Bank of America, N.A., shall be subject
to a control agreement in form and substance satisfactory to Lender, and all
Depository Accounts currently maintained with Bank of America, N.A., shall be
replaced with accounts maintained with another depository institution and
subject to a control agreement in form and substance satisfactory to Lender, and
(B) each of the Letters of Credit issued by Bank of America, N.A., shall have
been replaced by a Letter of Credit issued by Lender or an affiliate of Lender
with the consent of the beneficiary named in such Letter of Credit."

         (d) The first sentence of the definition of "EBITDA" set forth on
Supplement A to the Loan Agreement shall be deleted in its entirety and replaced
with the following: "'EBITDA' means, as of the last day of any specified
calendar month, Borrower's consolidated net earnings before interest expense,
depreciation, amortization and provision for Taxes of the Borrower for the
twelve-month period ending on such day."

                                       2
<PAGE>

         SECTION 3. Representations, Warranties and Covenants of the Borrowers.
Each of the Borrowers represents and warrants to the Lender, and agrees that:

               (a) the representations and warranties contained in the Loan
         Agreement (as amended hereby) and the other outstanding Related
         Agreements and Supplemental Documentation are true and correct in all
         material respects at and as of the date hereof as though made on and as
         of the date hereof, except (i) to the extent specifically made with
         regard to a particular date, (ii) with respect to the Shine Writs of
         Attachment (as defined in the Fifth Amendment) and the Shine Lawsuit
         (as defined in the Fifth Amendment) and (iii) for such changes as are a
         result of any act or omission specifically permitted under the Loan
         Agreement (or under any Related Agreement), or as otherwise
         specifically permitted by the Lender;

               (b) on the Eighth Amendment Effective Date, after giving effect
         to this Eighth Amendment, no Unmatured Event of Default or Event of
         Default will have occurred and be continuing;

               (c) the execution, delivery and performance of this Eighth
         Amendment has been duly authorized by all necessary action on the part
         of, and duly executed and delivered by the Borrowers, and this Eighth
         Amendment is a legal, valid and binding obligation of the Borrowers
         enforceable against each Borrower in accordance with its terms, except
         as the enforcement thereof may be subject to the effect of any
         applicable bankruptcy, insolvency, reorganization, moratorium, or
         similar laws affecting creditors' rights generally and general
         principles of equity (regardless of whether such enforcement is sought
         in a proceeding in equity or at law); and

               (d) the execution, delivery and performance of this Eighth
         Amendment does not conflict with or result in a breach by any Borrower
         of any term of any material contract, loan agreement, indenture or
         other agreement or instrument to which such Borrower is a party or is
         subject.

         SECTION 4. Conditions Precedent to Effectiveness of Eighth Amendment.
This Eighth Amendment shall become effective (the "Eighth Amendment Effective
Date") upon completion of each of the following in form and substance
satisfactory to Lender: (a) execution and delivery of this Eighth Amendment by
Lender, Borrowers and Parent; (b) the delivery to Lender of an Allonge to each
outstanding Note, executed by each of the Borrowers, and (c) delivery by
Borrowers of such other documents as the Lender may reasonably request.

         SECTION 5. Breach of this Eighth Amendment. Default in the performance
by any Borrower of any of Borrower's agreements set forth herein and continuance
of such default for three (3) Business Days after notice thereof to Borrower
from Lender shall constitute an Event of Default under the Loan Agreement.

         SECTION 6. Execution in Counterparts. This Eighth Amendment may be
executed in counterparts, each of which when so executed and delivered shall be
deemed to be an original and all of which taken together shall constitute but
one and the same instrument.

                                       3
<PAGE>

         SECTION 7. Costs and Expenses. The Borrower hereby affirms its
obligation under Section 11.3 of the Loan Agreement to reimburse Lender for all
reasonable costs, internal charges and out-of-pocket expenses paid or incurred
by Lender in connection with the preparation, negotiation, execution and
delivery of this Eighth Amendment, including but not limited to the attorneys'
fees and time charges of attorneys for Lender with respect thereto.

         SECTION 8. GOVERNING LAW. THIS EIGHTH AMENDMENT SHALL BE GOVERNED BY,
AND CONSTRUCTED AND INTERPRETED IN ACCORDANCE WITH, THE LAWS OF THE STATE OF
ILLINOIS, WITHOUT REGARD TO THE INTERNAL CONFLICTS OF LAWS PROVISIONS THEREOF.

         SECTION 9. Effect of Amendment; Reaffirmation of Loan Documents. The
parties hereto agree and acknowledge that (a) nothing contained in this Eighth
Amendment in any manner or respect limits or terminates any of the provisions of
the Loan Agreement or the other outstanding Related Agreements or Supplemental
Documentation other than as expressly set forth herein and (b) the Loan
Agreement (as amended hereby) and each of the other outstanding Related
Agreements and Supplemental Documentation remain and continue in full force and
effect and are hereby ratified and reaffirmed in all respects. Upon the
effectiveness of this Eighth Amendment, each reference in the Loan Agreement to
"this Agreement", "hereunder", "hereof", "herein" or words of similar import
shall mean and be a reference to the Loan Agreement as amended hereby.

         SECTION 10. Headings. Section headings in this Eighth Amendment are
included herein for convenience of any reference only and shall not constitute a
part of this Eighth Amendment for any other purposes.

         SECTION 11. Release. EACH BORROWER HEREBY ACKNOWLEDGES THAT AS OF THE
DATE HEREOF IT HAS NO DEFENSE, COUNTERCLAIM, OFFSET, CROSS-COMPLAINT, CLAIM OR
DEMAND OF ANY KIND OR NATURE WHATSOEVER THAT CAN BE ASSERTED TO REDUCE OR
ELIMINATE ALL OR ANY PART OF ITS LIABILITY TO REPAY THE LIABILITIES OR TO SEEK
AFFIRMATIVE RELIEF OR DAMAGES OF ANY KIND OR NATURE FROM LENDER OR ITS
AFFILIATES, PARTICIPANTS OR ANY OF THEIR RESPECTIVE DIRECTORS, OFFICERS, AGENTS,
EMPLOYEES OR ATTORNEYS. EACH BORROWER HEREBY VOLUNTARILY AND KNOWINGLY RELEASES
AND FOREVER DISCHARGES LENDER, AND ITS AFFILIATES AND PARTICIPANTS, AND ITS
PREDECESSORS, AGENTS, OFFICERS, DIRECTORS, EMPLOYEES, SUCCESSORS AND ASSIGNS,
FROM ALL POSSIBLE CLAIMS, DEMANDS, ACTIONS, CAUSES OF ACTION, DAMAGES, COSTS,
EXPENSES, AND LIABILITIES WHATSOEVER, KNOWN OR UNKNOWN, ANTICIPATED OR
UNANTICIPATED, SUSPECTED OR UNSUSPECTED, FIXED, CONTINGENT, OR CONDITIONAL, AT
LAW OR IN EQUITY, ORIGINATING IN WHOLE OR IN PART ON OR BEFORE THE DATE THIS
EIGHTH AMENDMENT IS EXECUTED, WHICH ANY BORROWER MAY NOW OR HEREAFTER HAVE
AGAINST LENDER, ITS PREDECESSORS, AGENTS, OFFICERS, DIRECTORS, EMPLOYEES,
SUCCESSORS AND ASSIGNS, IF ANY, AND IRRESPECTIVE OF WHETHER ANY SUCH CLAIMS
ARISE OUT OF CONTRACT, TORT, VIOLATION OF LAW OR REGULATIONS, OR OTHERWISE, AND

                                       4
<PAGE>

ARISING FROM THE LIABILITIES, THE EXERCISE OF ANY RIGHTS AND REMEDIES UNDER THE
LOAN AGREEMENT OR RELATED AGREEMENTS, SUPPLEMENTAL DOCUMENTATION OR OTHER LOAN
DOCUMENTS, AND NEGOTIATION FOR AND EXECUTION OF THIS EIGHTH AMENDMENT. EACH
BORROWER HEREBY COVENANTS AND AGREES NEVER TO INSTITUTE ANY ACTION OR SUIT AT
LAW OR IN EQUITY, NOR INSTITUTE, PROSECUTE, OR IN ANY WAY AID IN THE INSTITUTION
OR PROSECUTION OF ANY CLAIM, ACTION OR CAUSE OF ACTION, RIGHTS TO RECOVER DEBTS
OR DEMANDS OF ANY NATURE AGAINST LENDER, ITS AFFILIATES, AND PARTICIPANTS, AND
THEIR RESPECTIVE SUCCESSORS, AGENTS, ATTORNEYS, OFFICERS, DIRECTORS, EMPLOYEES,
AND PERSONAL AND LEGAL REPRESENTATIVES ARISING ON OR BEFORE THE DATE HEREOF OUT
OF OR RELATED TO LENDERS' ACTIONS, OMISSIONS, STATEMENTS, REQUESTS OR DEMANDS IN
ADMINISTERING, ENFORCING, MONITORING, COLLECTION OR ATTEMPTING TO COLLECT THE
INDEBTEDNESS OF BORROWER TO LENDER, WHICH INDEBTEDNESS WAS EVIDENCED BY THE LOAN
AGREEMENT, RELATED AGREEMENTS, SUPPLEMENTAL DOCUMENTATION AND OTHER LOAN
DOCUMENTS.

                            [Signature Pages Follow]

                                       5
<PAGE>

         IN WITNESS WHEREOF, the parties hereto have caused this Eighth
Amendment to be executed by their respective officers thereunto duly authorized
as of the date first written above.

                             ELXSI

                             By: /s/ David Doolittle
                                 -----------------------------------------------
                             Name: David Doolittle
                                   ---------------------------------------------
                             Title: Vice President
                                    --------------------------------------------

                             Address: 3600 Rio Vista Avenue, Suite A
                                      Orlando, Florida  32805

                             Attention:  President
                             Facsimile number:  407-849-0625

                             BICKFORD'S HOLDINGS COMPANY, INC.

                             By: /s/ David Doolittle
                                 -----------------------------------------------
                             Name: David Doolittle
                                   ---------------------------------------------
                             Title: Vice President
                                    --------------------------------------------

                             Address: 3600 Rio Vista Avenue, Suite A
                                      Orlando, Florida  32805

                             Attention:  President
                             Facsimile number:  407-849-0625

                             BICKFORD'S FAMILY RESTAURANTS, INC.

                             By: /s/ David Doolittle
                                 -----------------------------------------------
                             Name: David Doolittle
                                   ---------------------------------------------
                             Title: Vice President
                                    --------------------------------------------

                             Address: 3600 Rio Vista Avenue, Suite A
                                      Orlando, Florida  32805

                             Attention:  President
                             Facsimile number:  407-849-0625

                                       6
<PAGE>

                             WELLS FARGO FOOTHILL, INC.

                             By: /s/ Daniel Morihiro
                                 -----------------------------------------------
                             Name: Daniel Morihiro
                                   ---------------------------------------------
                             Title: Vice President
                                    --------------------------------------------

                             Address: 2450 Colorado Avenue, Suite 3000 West
                                      Santa Monica, CA  90404

                             Attention:  Group Credit Manager--Specialty Finance
                             Facsimile number:  310-453-7442

                                       7
<PAGE>

                         ACKNOWLEDGMENT AND RATIFICATION

         The undersigned hereby (i) acknowledges receipt of a copy of the
foregoing Eighth Amendment to Amended and Restated Loan and Security Agreement,
(ii) consents to all of the terms and provisions thereof, (iii) ratifies and
confirms all of the terms and provisions of the outstanding Related Agreements
to which it is a party; and (iv) acknowledges and agrees that all references in
the outstanding Related Agreements to any loan or credit agreement executed by
and between any of the Borrowers and Lender shall refer without further
amendment to the Loan Agreement as amended by the foregoing Eighth Amendment.

                             ELXSI CORPORATION

                             By: /s/ David Doolittle
                                 -----------------------------------------------
                             Name: David Doolittle
                                   ---------------------------------------------
                             Title: Vice President
                                    --------------------------------------------

                             Address: 3600 Rio Vista Avenue, Suite A
                                      Orlando, Florida  32805

                             Attention:  President
                             Facsimile number:  407-849-0625

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