EX-10.46 3 v016376_ex10-46.txt Exhibit 10.46 LICENSE AND SUPPLY AGREEMENT THIS LICENSE & SUPPLY AGREEMENT ("Agreement") is made and effective this 13th day of September 2004, by and between AMARILLO BIOSCIENCES, INC., a Texas corporation with its principal place of business at 4134 Business Park Drive, Amarillo, Texas 79110 (hereinafter "ABI") and NOBEL ILAC SANAYII VE TICARET A.S. and its affiliates, a company organized under the laws of Turkey with its principal place of business at Barbaros Bulvari 76/78 Besiktas 34353 ISTANBUL / Turkey (hereinafter "NOBEL") (ABI and NOBEL are hereinafter collectively referred to as the "Parties"). WHEREAS, ABI and its contract suppliers have substantial expertise in the production and use of oral interferon alpha (hereinafter, "IFN-(alpha)") and have proprietary rights and know-how in the field of production, purification and formulation of IFN-(alpha); WHEREAS, ABI is willing to disclose to NOBEL Technical Information consisting of human data for hepatitis B, hepatitis C, Behcet's Disease (BD), AIDS and all other data, including safety, bioavailability, and clinical trial data necessary for NOBEL to obtain regulatory approval for a hepatitis B or hepatitis C or BD or AIDS product in the Territory; and WHEREAS, ABI has an exclusive worldwide license (except Japan) to market and distribute the oral formulation of HBL IFN-(alpha) (as defined in ARTICLE I, below), and desires to provide HBL IFN-(alpha) to NOBEL on the terms and conditions herein set forth, and NOBEL desires to obtain the right to perform clinical trials, distribute and market HBL IFN-(alpha) contained in Licensed Product on the terms and conditions herein set forth; NOW, THEREFORE, for and in consideration of the mutual covenants contained herein, and for other good and adequate consideration the receipt and sufficiency of which are evidenced by the execution hereof, ABI and NOBEL agree as follows: **** Indicates that a portion of the text has been omitted and filed separately with the Commission CONFIDENTIAL 1 ARTICLE I DEFINITIONS 1.1 "ABI" and "NOBEL" shall mean and include not only the indicated company, but also such company's Assignees. 1.2 "Affiliate" means a corporation, company, partnership, or other business entity which controls or is controlled by, or is under common control with, the designated party. In the case of a corporation or company, "control" means ownership either directly or indirectly of at least Fifty Percent (50%) of the shares of stock entitled to vote for the election of Directors. 1.3 "Agreement" means this License and Supply Agreement. 1.4 "Assignee" means any permitted assignee or sub-licensee of rights under this Agreement 1.5 "Dose" means 500 International Units (IU) of IFN-(alpha). 1.6 "HBL IFN-(alpha)" means the cell culture derived human lymphoblastoid IFN-(alpha) used for the Licensed Product by ABI and produced by HAYASHIBARA BIOCHEMICAL LABORATORIES, INC. ("HBL"). 1.7 "Licensed Indications" means all human indications treated or treatable by the oral administration of IFN-(alpha). 1.8 "Licensed Product" means a formulation or composition containing HBL IFN-(alpha) and designated, detailed, or labeled for oral use in the treatment of the Licensed Indications. 1.9 "MOH" means Ministry of Health in each individual country in the Territory. **** Indicates that a portion of the text has been omitted and filed separately with the Commission CONFIDENTIAL 2 1.10 "Technical Information" means all information, reports, results, inventions, know how, materials, and any other technical and scientific data, specifications and formulae directly related to the development, regulatory approval, manufacture, testing, use, marketing and/or sale of Licensed Product, and any non-public information relevant to the business of the Parties which is necessarily disclosed by one to the other during the Parties' conduct under this Agreement. "ABI Technical Information" refers to Technical Information originating with ABI or which ABI has obtained through its contractual relationships with third parties. "NOBEL Technical Information" refers to Technical Information originating with NOBEL or which NOBEL has obtained through its contractual relationships with third parties. "Technical Information" when not otherwise specified herein means both ABI Technical Information and NOBEL Technical Information. 1.11 "Territory" means Azerbaijan, Bosnia & Herzegovina, Bulgaria, Croatia, Georgia, Kazakhstan, Kyrgyzstan, Macedonia, Romania, Russia, Saudi Arabia, Slovenia, Tajikistan, Turkey, Turkmenistan, Uzbekistan, and Federal Republic of Yugoslavia. ARTICLE II GRANT OF LICENSE 2.1 ABI grants to NOBEL and NOBEL accepts, subject to the terms of this Agreement, the exclusive right to use HBL IFN-(alpha) for clinical testing and trials, and upon proper regulatory approval, the exclusive right to market and distribute Licensed Product to treat the Licensed Indications in the Territory. ABI will provide NOBEL Technical Information for the above-mentioned purposes at no cost to NOBEL. ABI retains all other rights to HBL IFN-(alpha), including without limitation, the right to test, develop, license, sub-license, market, distribute or otherwise use HBL IFN-(alpha) for treatment of all indications other than the Licensed Indications, and for treatment of the Licensed Indications in all countries not included in the Territory. **** Indicates that a portion of the text has been omitted and filed separately with the Commission CONFIDENTIAL 3 2.2 The license granteded to NOBEL under this Agreement shall commence on the effective date of this Agreement and shall terminate immediately upon the termination or expiration of this Agreement as defined in Article VI,. 2.3 NOBEL shall have the right to use and sell Licensed Product only in the Territory. NOBEL shall not seek customers, establish any branch or maintain any distribution depot for Licensed Product in any country outside the Territory. NOBEL shall not sell Licensed Product to any customer in any country outside the Territory or to any customer in the Territory if, to the knowledge of NOBEL, such customer intends to resell the Licensed Product in any country outside the Territory. NOBEL shall cause ABI's name to appear on each outer package of the Licensed Product distributed in the Territory, providing that it complies with local laws and Ministry of Health regulations. 2.4 Licensed Product sold by NOBEL shall bear the trademark "Veldona" or another trademark proposed by NOBEL to which ABI agrees, acknowledging ABI as developer and manufacturer, providing that it complies with local laws and MOH regulations. NOBEL shall own all rights to such trademarks in the Territory, even if NOBEL ceases marketing the Licensed Product. ARTICLE III SUPPLY OF PRODUCT 3.1 Subject to the terms and conditions of this Agreement, ABI shall supply clinical trial samples, including 500 IU HBL IFN-(alpha) lozenges and placebos to NOBEL at $**** and $**** per dose, respectively, and (upon government approval) will provide Licensed Product for sale in the Territory for the consideration set forth in Paragraph 4.1, below. The quantity of clinical trial samples provided for clinical testing will be agreed to by the Parties as part of the clinical development plan. Licensed Product shall be supplied in response to issuance by NOBEL of written purchase orders delivered to ABI specifying the quantity to be supplied, along with any special instructions/requests regarding supply and/or delivery. Nobel shall have the right to purchase the Licensed Product through a company located in Europe. ABI shall have no responsibility for obtaining any required regulatory approvals, nor for distribution, promotion, pricing, or marketing of lozenges in the Territory, all of which shall be completed by NOBEL with the assistance of ABI. **** Indicates that a portion of the text has been omitted and filed separately with the Commission CONFIDENTIAL 4 3.2 ABI agrees to allow NOBEL right of reference to ABI's US FDA Drug Master File for HBL IFN-(alpha) and to do such other acts as are reasonably necessary, and within ABI's control, to facilitate approval of HBL IFN-(alpha)-containing lozenges in the Territory for use in the Licensed Indications, and ABI also hereby agrees to consult with NOBEL at NOBEL's request concerning regulatory affairs, to review documents to be submitted to governmental agencies for approval, and to take such other actions as may be necessary from time to time to facilitate approval of Licensed Product for sale and use in the Territory. ABI also agrees to provide clinical data from its past, current or future studies, relating to safety or bioavailability, or clinical data relating to the use of HBL IFN-(alpha) in hepatitis B, hepatitis C, BD or AIDS. NOBEL will be responsible for packaging and labeling of the clinical trial material. Further, NOBEL will be responsible for the preparation of all necessary materials including protocols, case report forms, and Investigator Brochures as required for conducting the clinical trials in the Territory. ABI shall reasonably provide to NOBEL other support or assistance requested by NOBEL and within ABI's capabilities with respect to regulatory and clinical activities free of charge. ARTICLE IV CONSIDERATION 4.1 For all Licensed Product supplied by ABI to NOBEL (other than quantities provided pursuant to Paragraph 3.2 above), ABI shall receive from NOBEL the payment per Dose specified at Exhibit "A" for Turkey. The price per dose for the countries of Azerbaijan, Bosnia & Herzegovina, Bulgaria, Croatia, Georgia, Kazakhstan, Kyrgyzstan, Macedonia, Romania, Russia, Saudi Arabia, Slovenia, Tajikistan, Turkmenistan, Uzbekistan, and Federal Republic of Yugoslavia shall be determined by both parties according to market and regulatory conditions of each individual country. Payment for each shipment of Licensed Product shall be made by NOBEL by irrevocable letter of credit on a U.S. bank. The price per Dose shall be further adjusted from time to time as may be necessary to reflect any Change in the Producers Price Index, Drugs and Pharmaceuticals, Subdivision Code 063, after the date of this Agreement. In addition, both the price per Dose and the amount to be invoiced and paid for Licensed Product shall be further adjusted to reflect any changes for (i) the variable cost of any raw material or combination of raw materials that changes by more than twenty percent (20%) from ABI's cost at the date of this Agreement, and (ii) the variable cost arising from changes in product specifications, manufacturing, testing, or release of the product; provided, however, that if such variable cost increases occur within five (5) years after the date of approval of a Licensed Product for sale in the Territory, under circumstances where MOH does not permit an increase in the sales price of the Licensed Product, then the price adjustment otherwise provided for under this sentence shall be reduced by fifty percent (50%). NOBEL shall receive Licensed Product at HBL's manufacturing location in Okayama, Japan and the shipping arrangements shall be made by NOBEL's shipping agent. NOBEL shall pay the price set forth at Exhibit A, which price does not include freight and insurance. Title to Licensed Product purchased by NOBEL shall transfer to NOBEL, and NOBEL shall pay all freight charges and bear the risk of loss and damage, from the time Licensed Product is placed at the disposal of NOBEL at the manufacturing location in Okayama, Japan. **** Indicates that a portion of the text has been omitted and filed separately with the Commission CONFIDENTIAL 5 4.2 The Parties agree to a strategy of conducting BD studies in Turkey (at NOBEL's expense) under an IND granted to ABI by the US FDA. The Parties further agree that US FDA approval will be sought and this FDA approval and resultant Free Sale Certificate will be owned by ABI but will be used by NOBEL to seek regulatory approval in each country of the Territory. The Parties agree that ABI, as the sponsor of the IND, must file the NDA (New Drug Application) with the US FDA at ABI's expense. The expense of monitoring the Turkish clinical trials will be shared 50:50 between the Parties. NOBEL shall three (3) months after receiving the approvals from local IRB and Ethical Commities of MOH commence a clinical trial for the BD indication using protocols developed jointly and approved by ABI. NOBEL will conduct all clinical trials at its own expense. NOBEL shall, within six (6) months of the conclusion of the appropriate clinical study, apply for, at its own cost and expense and without any financial contribution from ABI, all necessary licenses, registrations or approvals required to be issued in the Territory, or any agency or instrumentality thereof, as a precondition to the import and sale of Licensed Product. NOBEL will apply for any pricing or reimbursement approvals, will exercise diligence to maintain all such approvals, and will diligently market the approved Licensed Product through the term of this Agreement. NOBEL will launch Licensed Product in the Territory within three (3) months of receipt of all necessary governmental approvals, and shall thereafter use its best efforts to advertise, promote and sell such Licensed Product after such approval as far as the MOH regulations allow. If at any time during the term of this Agreement NOBEL should fail to comply in a timely way with any of the requirements set forth in this Section 4.2, or if at any time during the term of this Agreement NOBEL should no longer be actively pursuing the application for any such approval or license in the Territory, or if, having obtained such approval or license, NOBEL should no longer be actively developing or marketing any Licensed Product under this Agreement in the Territory, under the preconditions permitted by applicable laws and regulations, both parties shall enter into consultation to decide the assignment of such applications, approvals and/or licenses from NOBEL. **** Indicates that a portion of the text has been omitted and filed separately with the Commission CONFIDENTIAL 6 4.3 NOBEL shall provide ABI by December 31st of each year during the term of this Agreement, a report of ongoing efforts for the development of Licensed Products, including a report of efforts by NOBEL with respect to clinical testing, regulatory approval efforts, marketing/sales strategy, and any other areas into which NOBEL's reasonable business efforts in accordance with this paragraph may reasonably be categorized. Such report shall be provided in English and shall be accompanied by labeling, instructions, promotional and other support materials developed for NOBEL's sales force, patients, physicians, or other outside parties. Such a report shall be prepared more often if ABI so requests in writing, provided that ABI pays to NOBEL the expenses incurred by NOBEL in generating such additional reports. It is understood that ABI will receive a copy in English of all NOBEL Technical Information. **** Indicates that a portion of the text has been omitted and filed separately with the Commission CONFIDENTIAL 7 4.4 During the term of this Agreement, NOBEL shall provide to ABI all data relating to the clinical testing and development of the Licensed Product for the Licensed Indications. ABI shall be allowed to use all clinical results obtained in the Territory and subject to notification to NOBEL, to use these results in non-NOBEL territories, as long as ABI shares 50:50 with NOBEL any option or license fee ABI receives in any country outside the USA or outside the Territory. 4.5 Unless specifically authorized in writing by ABI, NOBEL shall not sell, or offer for sale or act as sales agent for the solicitation of orders for any oral products (other than Licensed Products) that contain any IFN-(alpha) derived from any species and designated, detailed, or labeled for oral use for the Licensed Indications. ABI shall not authorize any third parties, directly or indirectly, to market or sell any IFN-(alpha) in the Territory for oral use in the treatment of the Licensed Indications. 4.6 NOBEL shall provide medical, pharmaco-vigilance and other appropriate customer support services in connection with sale of Licensed Products, and will report to ABI on a timely basis all material adverse reactions, product complaints and other relevant customer feedback. NOBEL agrees to advise ABI fully with respect to health, safety, environmental, and other standards, specifications, and other requirements imposed by law, regulation, or order in the Territory and applicable to Licensed Product which may be brought to NOBEL's attention from time to time, and which would have a material effect on the use or sale of Licensed Product for Licensed Indications in the Territory. NOBEL shall also advise ABI of all instructions, warnings, and labels applicable to Licensed Product for the Licensed Indications that are necessary or desirable under laws, regulations, or practices in the Territory. ABI shall meet such safety standards or specifications. ABI shall not increase the price charged to NOBEL for the Licensed Product unless changes to the specification are required. **** Indicates that a portion of the text has been omitted and filed separately with the Commission CONFIDENTIAL 8 ARTICLE V ORDERS AND SHIPMENTS 5.1 Within ninety (90) days of the date hereof, and at least ninety (90) days prior to the commencement of each calendar year during the term of this Agreement, NOBEL will furnish ABI with its projected requirements for Licensed Product during the next succeeding calendar year. NOBEL may amend its projected requirements from time-to-time, provided, however, that ABI shall be obligated only to make its best effort to comply with any requests in excess of annual projections received by it at least ninety (90) days prior to the commencement of the calendar year in question. Under no circumstances shall ABI be required to deliver to NOBEL, hereunder, an amount of Licensed Product which exceeds the amount ABI is able, in good faith, to acquire from HBL, or from HBL's contract manufacturers. The exact composition of Licensed Product shall be disclosed in writing by ABI to NOBEL. Subject to the foregoing, ABI shall use its best efforts to deliver Licensed Product in accordance with NOBEL's projected requirements and product specifications. 5.2 ABI shall ship the Licenced Product within thirty (30) days of request by NOBEL, against anirrevocable letter of credit on a U.S. bank (or other financial surety acceptable to ABI or to the agent nominated by ABI) in an amount sufficient to cover the purchase price payable to ABI or the agent nominated by ABI under Paragraph 4.1 above. The letter of credit shall be issued by a financial institution acceptable to ABI or to the agent nominated by ABI, shall be in U.S. dollars and shall not expire until the final payment for the respective shipment has been made to ABI or to the agent nominated by ABI. 5.3 Orders of Licensed Product for commercial sales shall be made for "full lot" quantities of 500,000 Doses. NOBEL shall meet or exceed the following annual minimum purchases from ABI. If NOBEL does not achieve these levels, it will enter into consultations with ABI to evaluate and remedy the situation, after which NOBEL will have the opportunity to make up the difference by either purchasing product or by cash payment within 90 days of the end of the period. If NOBEL does not elect to so make up the difference, then ABI will have the right to make the Agreement non-exclusive, and appoint another licensee or market the Product under the ABI name. **** Indicates that a portion of the text has been omitted and filed separately with the Commission CONFIDENTIAL 9 1st twelve months after launch 500,000 doses 2nd twelve months after launch 1.5 million doses 3rd twelve months after launch and beyond 3 million doses ARTICLE VI TERM AND TERMINATION 6.1 This Agreement and all rights granted hereunder by each Party shall terminate ten (10) years after the first market approval in Turkey, and if not cancelled by NOBEL, will be extended on a yearly basis by a request of NOBEL at least one hundred and eighty (180) days prior to the expiration date; If (a) NOBEL does not commence application for government approval, as may be required or advisable, within six (6) months after NOBEL receives all supporting documentation required for application for approval of commencement of the pivotal clinical trial; and (b) after approval of the Licensed Product, place orders for minimum annual shipments as provided in Paragraph 5.3, above; then ABI shall have the right to terminate this Agreement upon ninety (90) days prior written notice to NOBEL. NOBEL will proceed diligently to obtain market approval for the Territory according to the timetable set forth in paragraph 4.2 of this Agreement. If NOBEL fails to commence clinical trials under the IND granted to ABI by the US FDA as agreed in Paragraph 4.2, then ABI shall have the right to terminate this Agreement upon ninety (90) days prior written notice to NOBEL. 6.2 Termination of this Agreement for any reason shall not relieve the Parties of any obligation accruing prior to such termination. In addition, ARTICLE VIII ("Confidentiality") shall survive termination of this Agreement. **** Indicates that a portion of the text has been omitted and filed separately with the Commission CONFIDENTIAL 10 6.3 On termination of this Agreement for any reason set forth herein, NOBEL shall cease to sell Licensed Product after it sells all Licensed Product in its inventory that has already been paid for, and shall surrender to ABI all ABI Technical Information that it may have received during the term of this Agreement, and at the request of ABI, NOBEL may conditionally assign any approval, permit, or license it holds relating to Licensed Product to ABI. Any accrued payment obligations shall be paid within thirty (30) days of the termination of this Agreement. ARTICLE VII WARRANTY AND INDEMNIFICATION 7.1 ABI represents and warrants that as of the date of this Agreement, it is the exclusive owner of the right to sell and distribute Licensed Product for use in treating the Licensed Indications in the Territory. ABI further warrants that at the time of shipment, all Licensed Product supplied by it (i) shall meet all product specifications previously agreed in writing between ABI and NOBEL; (ii) shall not be adulterated or misbranded; and (iii) shall be manufactured in accordance with good manufacturing practices in the country of manufacture. ABI shall indemnify and hold NOBEL harmless from any and all costs, expenses, damages, judgments, and liabilities incurred by or rendered against NOBEL arising from any claim made or suit brought as a result of a breach by ABI of its warranties under this Paragraph 7.1. 7.2 NOBEL warrants that its operations and activities in the Territory shall be in compliance with applicable laws, statutes and regulations; and NOBEL shall indemnify and hold ABI harmless from any and all costs, expenses, damages, judgments, and liabilities incurred by or rendered against ABI or its Affiliates arising from the use, testing, recall, labelling, promotion, sale, or distribution of Licensed Product as a result of any breach of such warranty by NOBEL. ABI warrants that the manufacture of Licensed Product, including without limitation both bulk interferon alpha and finished product, shall be in compliance with applicable laws, statutes and regulations, and ABI shall indemnify and hold NOBEL harmless from any and all costs, expenses, damages, judgments, and liabilities incurred by or rendered against NOBEL or its Affiliates arising from the use, testing, recall, labeling, promotion, sale or distribution of Licensed Product as a result of any breach of such warranty by ABI. **** Indicates that a portion of the text has been omitted and filed separately with the Commission CONFIDENTIAL 11 ARTICLE VIII CONFIDENTIALITY 8.1 ABI owns or is licensed under confidential or secret information relating to the Licensed Products, and NOBEL intends to conduct trials in the Territory, which will generate confidential or secret information relating to the Licensed Products, and it is the intention of both ABI and NOBEL to maintain this confidentiality. 8.2 Each Party agrees to maintain confidential and secret all Technical Information which may be disclosed or provided to it by the other Party or that the Parties may together subsequently acquire. 8.3 Each Party's obligation to the other to maintain confidentiality hereunder shall terminate with respect to any particular item and only said item of the disclosing Party's Technical Information, when the recipient Party can demonstrate that such item of information: 8.3.1 Is publicly known and available through some means other than by the recipient Party's act or omission; or 8.3.2 Was in the recipient Party's possession prior to its disclosure by the other Party, as established by written evidence; or 8.3.3 Has come into the recipient Party's possession through a third party free of any obligation of confidentiality to the disclosing Party, where said third party has acquired said information lawfully and not under circumstances forbidding its disclosure. **** Indicates that a portion of the text has been omitted and filed separately with the Commission CONFIDENTIAL 12 8.4 Neither Party will permit the other Party's Technical Information or any part thereof to be disclosed to third parties or to employees except on a "need-to-know" basis and each will maintain such information and/or documents with the same precautions it uses to safeguard its own confidential or secret information. 8.5 Each Party will notify the other promptly if it has knowledge that an unauthorized third party possesses Technical Information of the other Party. 8.6 NOBEL shall have the right to use ABI's Technical Information, and to access ABI's US FDA Drug Master File for HBL IFN-(alpha), to the extent reasonably necessary to accomplish the objectives of this Agreement. 8.7 Upon written notification to NOBEL, ABI may use NOBEL's Technical Information for the purposes of designing protocols and studies, and for submission to regulatory authorities in any country outside the Territory in connection with an application for drug approval of the Product, subject, however, to the provisions of Section 4.4 regarding use of clinical data. ARTICLE IX MISCELLANEOUS 9.1 Force Majeure. The failure of NOBEL, ABI, or any of their Affiliates to take any action required by this Agreement if such failure is occasioned by an act of God or the public enemy, fire, explosion, perils of the sea, floods, drought, war, riot, sabotage, accident, embargo or any circumstance of like or different character beyond the reasonable control of the Party so failing or by the interruption or delay in transportation, inadequacy, or shortage or failure of the supply of materials and/or equipment, equipment breakdown, labor trouble or compliance with any order, direction, action or request of any governmental officer, department or agency and whether in any case such circumstances now exist or hereafter arise, shall not subject said Party to any liability to the other. **** Indicates that a portion of the text has been omitted and filed separately with the Commission CONFIDENTIAL 13 9.2 Communication. Any payment, notice or other communication required or permitted to be made or given to either Party pursuant to this Agreement shall be sufficiently made or given on the date of sending if sent to such Party by certified or registered mail, or by courier service, postage or delivery charge prepaid, addressed to it at its address set forth below, or to such other address as it may have designated by written notice given to the other Party. Fax numbers are given for convenience only, as an additional method of delivery, and no notice or other communication transmitted by fax shall be considered to be sufficiently made or given until such notice or communication is also sent by one of the other means described above. In case of NOBEL: Hasan Ulusoy, Chairman Barbaros Bulvari 76/78 Besiktas 34353 Istanbul / Turkey Phone: 0-212-259-7490 Fax: 0-212-258-8789 Email: hasan.ulusoy@nobel.com.tr In case of ABI: Dr. Joseph M. Cummins, Chairman & CEO Amarillo Biosciences, Inc. 4134 Business Park Drive Amarillo, TX 79110 Phone: (806) 376-1741 x 13 Fax: (806) 376-9301 Email: jcummins@amarbio.com **** Indicates that a portion of the text has been omitted and filed separately with the Commission CONFIDENTIAL 14 And: Edward L. Morris, Legal Counsel SandersBaker, P.C. One Maxor Plaza 320 S. Polk, Suite 700 Amarillo, TX 79101 Phone: (806) 372-3725 Fax: (806) 372-3725 9.3 Amendments to Agreement. This Agreement constitutes the entire Agreement between the Parties hereto on this subject matter and supersedes all previous arrangements whether written or oral. Any amendment or modification of this Agreement shall be effective only if made in writing, and executed by both Parties. 9.4 Enforceability. To the extent permitted by law, each Party waives any provision of law which renders any provision herein invalid, illegal or unenforceable in any respect, provided it does not contradict local laws and MOH regulations. 9.5 Relationship of Parties. All purchases and resales of Licensed Product by NOBEL shall be for NOBEL's own account as a principal and not as an agent of ABI. NOBEL shall act in all respects as an independent contractor and not as a representative or agent of ABI. This Agreement shall not be construed to create a relationship of partners, joint venturers, brokers, employees, agents, master or servant between the Parties. Neither Party shall have any right or authority to assume or create any responsibility, express or implied, in the name of the other Party or to bind the other Party in any manner whatsoever. 9.6 Assignment. Neither Party hereto shall assign any of its rights under this Agreement to any person or entity not an Affiliate of the assigning Party without the prior written consent of the other Party, which consent shall not be unreasonably withheld. **** Indicates that a portion of the text has been omitted and filed separately with the Commission CONFIDENTIAL 15 9.7 Venue and Governing Law. Any controversy or claim arising out of or relating to this contract, or the breach thereof, shall be settled by arbitration administered by the American Arbitration Association under its Commercial Arbitration Rules and judgment. The number of arbitrator shall be one and the seat or legal place of arbitration shall be New York USA. The Language to be used in arbitral proceedings shall be English and the governing law of the contract shall be the substantive law of USA. 9.8 Governing Language. The English language of this Agreement shall govern and control any translations of the Agreement into any other language. Documents furnished by NOBEL to ABI under the terms of this Agreement shall be furnished in English, or alternatively, shall be accompanied by an English translation. IN WITNESS WHEREOF, the Parties hereunto have caused this instrument to be executed in duplicate by their duly authorized representatives as of the date first above written. ABI: NOBEL: AMARILLO BIOSCIENCES, INC. NOBEL ILAC SANAYII VE TICARET A.S. By: By: /s/ Joseph M. Cummins /s/ Hasan Ulusoy -------------------------------- --------------------------------------- Joseph M. Cummins, Hasan Ulusoy Chairman & CEO Chairman **** Indicates that a portion of the text has been omitted and filed separately with the Commission CONFIDENTIAL 16 EXHIBIT "A" This Exhibit "A" is attached to that certain License and Supply Agreement by and between AMARILLO BIOSCIENCES, INC. and NOBEL ILAC SANAYII VE TICARET A.S. and its affiliates dated September 13, 2004, and constitutes a part of said Agreement, as if fully set forth therein. ABI will supply to NOBEL either bulk finished lozenges from its subcontractor's plant for an agreed period of time up to a maximum quantity per year to be decided, at the price noted below. Finished bulk lozenges: $**** (US) per lozenge However, nothing in this Agreement shall obligate NOBEL to operate without a profit. If the MOH of Turkey sets the reimbursement price for interferon lozenges so low that NOBEL can not make a profit at $**** per lozenge, then ABI and NOBEL shall negotiate in good faith to adjust the price of finished bulk lozenges to NOBEL. 17