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 0000 Xxxxxxxx Xxxx
Xxxxx, Xxxxxxxx, Xxxxx 00000 (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 Xxxxxxx 00/00 Xxxxxxxx 00000
XXXXXXXX / Xxxxxx (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:
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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.
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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 Xxxxxxxxxx, Xxxxxx & Xxxxxxxxxxx, Xxxxxxxx, Xxxxxxx,
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.
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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.
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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 Xxxxxxxxxx, Xxxxxx & Xxxxxxxxxxx, Xxxxxxxx, Xxxxxxx, 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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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 Xxxxxxx
00/00 Xxxxxxxx
00000 Xxxxxxxx / Xxxxxx
Phone: 0-000-000-0000
Fax: 0-000-000-0000
Email: xxxxx.xxxxxx@xxxxx.xxx.xx
In case of ABI: Xx. Xxxxxx X. Xxxxxxx, Chairman & CEO
Amarillo Biosciences, Inc.
0000 Xxxxxxxx Xxxx Xxxxx
Xxxxxxxx, XX 00000
Phone: (000) 000-0000 x 00
Fax: (000) 000-0000
Email: xxxxxxxx@xxxxxxx.xxx
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And: Xxxxxx X. Xxxxxx, Legal Counsel
SandersBaker, P.C.
One Maxor Plaza
000 X. Xxxx, Xxxxx 000
Xxxxxxxx, XX 00000
Phone: (000) 000-0000
Fax: (000) 000-0000
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.
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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/ Xxxxxx X. Xxxxxxx /s/ Hasan Ulusoy
-------------------------------- ---------------------------------------
Xxxxxx X. Xxxxxxx, Hasan Ulusoy
Chairman & CEO Chairman
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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.
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