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EXHIBIT 10.39
LICENSE AND SUPPLY AGREEMENT
THIS LICENSE & SUPPLY AGREEMENT ("Agreement") is made and
effective this 25th day of April, 2000, by and between AMARILLO BIOSCIENCES,
INC., a Texas corporation with its principal place of business at 000 X. 0xx,
Xxxxxxxx, Xxxxx 00000 (hereinafter "ABI") and BIOPHARM FOR SCIENTIFIC RESEARCH
AND DRUG INDUSTRY DEVELOPMENT and its affiliates, a company organized under the
laws of Egypt with its principal place of business at 00 Xxxxxxxx Xx Xxxx, 00xx
Xxxxx, Xxxxx, Xxxxx, Xxxxx (hereinafter "BIOPHARM") (ABI and BIOPHARM are
hereinafter collectively referred to as the "Parties"). MITSUBISHI CORPORATION
is ABI's shipping agent with respect to product shipped to BIOPHARM under this
Agreement.
WHEREAS, ABI and its contract suppliers have substantial
expertise in the production and use of oral interferon alpha (hereinafter,
"IFN-a") and have proprietary rights and know-how in the field of production,
purification and formulation of IFN-a;
WHEREAS, ABI is willing to disclose to BIOPHARM Technical
Information consisting of human data for hepatitis B and hepatitis C and all
other data, including safety, bioavailability, and clinical trial data necessary
for BIOPHARM to obtain regulatory approval for a hepatitis B or hepatitis C
product in the Territory; and
WHEREAS, ABI has an exclusive worldwide license (except Japan)
to market and distribute the oral formulation of HBL IFN-a (as defined in
ARTICLE I, below), and desires to provide HBL IFN-a to BIOPHARM on the terms and
conditions herein set forth, and BIOPHARM desires to obtain the right to perform
clinical trials on, distribute and market HBL IFN-a contained in Licensed
Product on the terms and conditions herein set forth;
**** Indicates that a portion of the text has been omitted and filed separately
with the Commission
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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 BIOPHARM
agree as follows:
ARTICLE I
DEFINITIONS
1.1. "ABI" and "BIOPHARM" 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 150 International Units of IFN-a.
1.6. "HBL IFN-a" means the cell culture derived human
lymphoblastoid IFN-a 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-a.
1.8. "Licensed Product" means a formulation or composition
containing HBL IFN-a and designated, detailed, or labeled for oral use in the
treatment of the Licensed Indications.
1.9. "Technical Information" means all information, reports,
results, inventions, know-how, materials, and any other technical and scientific
data, specifications and formulae directly
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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. "BIOPHARM
Technical Information" refers to Technical Information originating with BIOPHARM
or which BIOPHARM has obtained through its contractual relationships with third
parties. "Technical Information" when not otherwise specified herein means both
ABI Technical Information and BIOPHARM Technical Information.
1.10. "Territory" means Arab Republic of Egypt, and such other
countries as may be added pursuant to the provisions of Section 9.2.
1.11. "MOH" means Ministry of Health in the Territory.
ARTICLE II
GRANT OF LICENSE
2.1. ABI grants to BIOPHARM and BIOPHARM accepts, subject to
the terms of this Agreement, the exclusive right to use HBL IFN-a 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 BIOPHARM technical information for the
above-mentioned purposes at no cost to BIOPHARM. ABI retains all other rights to
HBL IFN-a, including without limitation, the right to test, develop, license,
sub-license, market, distribute or otherwise use HBL IFN-a 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.
2.2. The license grant to BIOPHARM under this Agreement shall
commence on the effective date of this Agreement and shall terminate immediately
upon the termination or
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expiration of this Agreement unless extended by the parties at least one hundred
and eighty (180) days prior to the expiration date.
2.3. BIOPHARM shall have the right to use and sell Licensed
Product only in the Territory. BIOPHARM shall not seek customers, establish any
branch or maintain any distribution depot for Licensed Product in any country
outside the Territory. BIOPHARM 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 BIOPHARM, such customer intends to resell the Licensed Product
in any country outside the Territory. BIOPHARM 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 BIOPHARM shall bear the
trademark "BIOFERON-A" or another trademark proposed by BIOPHARM to which ABI
agrees, acknowledging ABI as developer and manufacturer, providing that it
complies with local laws and Ministry of Health regulations. ABI shall own all
rights to such trademarks. BIOPHARM will inform ABI if registration of such
trademark, in the opinion of BIOPHARM, is advisable. ABI hereby grants to
BIOPHARM during the term of this Agreement the exclusive license to use the
BIOFERON-A trademark or another trademark agreed to by the parties in the
Territory in connection with the use or sale of 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 150 I.U. HBL IFN-a lozenges
and placebos to BIOPHARM at no cost, 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
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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
BIOPHARM of written purchase orders delivered to ABI specifying the quantity to
be supplied, along with any special instructions/requests regarding supply
and/or delivery. 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 BIOPHARM with the
assistance of ABI.
3.2. ABI agrees to allow BIOPHARM right of reference to ABI's
US FDA Drug Master File for HBL IFN-a and to do such other acts as are
reasonably necessary, and within ABI's control, to facilitate approval of HBL
IFN-a-containing lozenges in the Territory for use in the Licensed Indications,
and ABI also hereby agrees to consult with BIOPHARM at BIOPHARM'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-a in hepatitis B or C. BIOPHARM
will be responsible for packaging and labeling of the clinical trial material.
Further, BIOPHARM will be responsible for the preparation of all necessary
materials including case report forms, and Investigator Brochures as required by
ABI for conducting the clinical trials in Egypt. ABI shall reasonably provide to
BIOPHARM other support or assistance requested by BIOPHARM and within ABI's
capabilities with respect to regulatory and clinical activities, on a fully
reimbursed basis for actual out-of-pocket expenses including time of key
personnel to be charged at $750.00 (US) per day.
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ARTICLE IV
CONSIDERATION
4.1. For all Licensed Product supplied by ABI to BIOPHARM
(other than quantities provided pursuant to Paragraph 3.2 above), ABI shall
receive from BIOPHARM the payment per Dose specified at Exhibit "A". Payment for
each shipment of Licensed Product shall be made by BIOPHARM 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%).
BIOPHARM shall receive Licensed Product at a named port of destination in the
Territory and the shipping arrangements shall be made by ABI's nominated
shipping agent (Mitsubishi Corporation). BIOPHARM shall pay the price set forth
at Exhibit A at the named port of destination in the Territory, which price
includes freight and insurance. Title to Licensed Product purchased by BIOPHARM
shall transfer to BIOPHARM, and BIOPHARM shall pay all freight charges and bear
the risk of loss and damage, from the time Licensed Product is placed at the
disposal of BIOPHARM at the port of destination.
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4.2. BIOPHARM shall within five (5) months of the Effective
date of this agreement commence clinical trials in the Licensed Indications
using protocols developed jointly and approved by ABI. BIOPHARM will conduct all
clinical trials at its own expense. BIOPHARM shall, within three (3) months of
the conclusion of the appropriate clinical study, apply for, at its own cost and
expense and without any 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. BIOPHARM 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. BIOPHARM 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. If at
any time during the term of this Agreement BIOPHARM 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 BIOPHARM 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, BIOPHARM 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 BIOPHARM.
4.3. BIOPHARM 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 BIOPHARM with
respect to clinical testing, regulatory approval efforts, marketing/sales
strategy, and any other areas into which BIOPHARM's reasonable business efforts
in accordance with this paragraph may reasonably be categorized. Such report
shall be provided in
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English and shall be accompanied by labeling, instructions, promotional and
other support materials developed for BIOPHARM'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 BIOPHARM the expenses
incurred by BIOPHARM in generating such additional reports. It is understood
that ABI will receive a copy in English of all BIOPHARM Technical Information.
4.4. During the term of this Agreement, BIOPHARM shall
provide to ABI all data relating to the clinical testing and development of the
Licensed Product for the Licensed Indications. ABI shall be free to use all
clinical results obtained in the Territory and subject to notification to
BIOPHARM, to use these results in non-BIOPHARM territories. The foregoing
notwithstanding, if ABI or its licensee or distributor should utilize hepatitis
C clinical trial data generated by or at the expense of BIOPHARM for the purpose
of filing or cross referencing with respect to an application for regulatory
approval in any jurisdiction outside the Territory under any arrangement or
agreement to which BIOPHARM is not a party, ABI shall pay to BIOPHARM the amount
of $50,000 per regulatory jurisdiction in which such use is made, until such
time as BIOPHARM shall have recouped the total amount of its expenditures with
respect to its hepatitis C clinical trials, and its regulatory approval
activities related thereto.
4.5 Unless specifically authorized in writing by ABI,
BIOPHARM 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-a 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-a in the Territory
for oral use in the treatment of the Licensed Indications.
4.6 BIOPHARM shall provide medical, pharmaco-vigilance and
other appropriate customer support services in connection with sale of Licensed
Products, and will report to ABI on
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a timely basis all material adverse reactions, product complaints and other
relevant customer feedback. BIOPHARM 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 BIOPHARM'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. BIOPHARM 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 BIOPHARM for the
Licensed Product unless changes to the specification are required.
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, BIOPHARM will furnish ABI with its projected requirements for
Licensed Product during the next succeeding calendar year. BIOPHARM 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 BIOPHARM 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 BIOPHARM. Subject to the foregoing, ABI
shall use its best efforts to deliver Licensed Product in accordance with
BIOPHARM's projected requirements and product specifications.
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5.2. ABI shall ship product within thirty (30) days of
request by BIOPHARM, against an irrevocable 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 CIF 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. BIOPHARM shall meet or exceed
the following annual minimum purchases from ABI. If BIOPHARM does not achieve
these levels, it will enter into consultations with ABI to evaluate and remedy
the situation, after which BIOPHARM 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 BIOPHARM 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.
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 years from the effective date of this agreement,
unless extended on a yearly basis by request of BIOPHARM at least one hundred
and eighty (180) days prior to the expiration date; provided, however, that if
(a) BIOPHARM does not commence application for government approval, as may be
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required or advisable, within five (5) months after BIOPHARM 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 BIOPHARM. BIOPHARM will proceed diligently to obtain
market approval for the Territory according to the timetable set forth in
paragraph 4.2 of this Agreement.
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.
6.3. On termination of this Agreement for any reason set
forth herein, BIOPHARM 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, BIOPHARM may
conditionally assign any approval, permit, or license it holds relating to
Licensed Products 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 product supplied by it
(i) shall meet all product specifications previously agreed in writing between
ABI and BIOPHARM; (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 BIOPHARM harmless from any and all
costs, expenses, damages, judgments, and liabilities
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incurred by or rendered against BIOPHARM 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. BIOPHARM warrants that its operations and activities in
the Territory shall be in compliance with applicable laws, statutes and
regulations; and BIOPHARM 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 BIOPHARM. 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 BIOPHARM harmless from any and all costs,
expenses, damages, judgments, and liabilities incurred by or rendered against
BIOPHARM 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.
ARTICLE VIII
CONFIDENTIALITY
8.1. ABI owns or is licensed under confidential or secret
information relating to the Licensed Products, and BIOPHARM 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
BIOPHARM 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.
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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.
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. BIOPHARM shall have the right to use ABI's Technical
Information, and to access ABI's US FDA Drug Master File for HBL IFN-a, to the
extent reasonably necessary to accomplish the objectives of this Agreement.
8.7. Upon written notification to BIOPHARM, ABI may use
BIOPHARM'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 hepatitis C
data.
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ARTICLE IX
MISCELLANEOUS
9.1. Force Majeure. The failure of BIOPHARM, 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.
9.2. Additional Countries. At any time during the term of
this Agreement, but in no event before December 1, 2000, if BIOPHARM should not
be in violation of any material provision of this Agreement, including without
limitation the milestones set forth in Section 4.2, above, BIOPHARM may request
from ABI the addition of one or more of the following countries to the
Territory: Saudi Arabia, United Arab Emirates, Yemen and Libya. ABI shall honor
such request by adding the requested country or countries to the Territory
within one (1) year of the receipt of such request in writing, unless ABI shall
at any time have received a proposal from another distributor or licensee with
terms more favorable to ABI than those set forth in this Agreement; and in such
case, ABI shall notify BIOPHARM of all of the material proposed terms and
conditions and BIOPHARM shall thereupon have an opportunity to accept such terms
and conditions, in which event this Agreement shall be appropriately amended by
the parties, in writing. Under no circumstances shall ABI enter into a
distribution agreement for the countries of Saudi Arabia, United Arab Emirates,
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Yemen, Libya, or any of them, without first having extended to BIOPHARM the
option to enter into such an arrangement upon the same or substantially similar
terms and conditions.
9.3. 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 BIOPHARM: Xx. Xxxxx Xxxxxx
------------------- Chairman & CEO
Biopharm International Group
0000 Xxxxxxxx Xxxx Xxxxx
Xxxxxxx, XX 00000 Fax (000) 000-0000
And: Xx. Xxxxx Xxxxxx
--- Chairman & CEO
Biopharm Healthcare Products Co.
00 Xxxxxxxx Xx Xxxx, 00xx Xxxxx
Xxxxx, Xxxxx, Xxxxx Fax 000-000-000-0000
In case of ABI: Xx. Xxxxxx X. Xxxxxxx
-------------- Chairman & CEO
Amarillo Biosciences, Inc.
000 X. 0xx
Xxxxxxxx, XX 00000 Fax: (000) 000-0000
And: Xxxxxx X. Xxxxxx, Legal Counsel
--- Xxxxxxx, Xxxxx & Xxxxxx, PC
X.X. Xxx 00000
Xxxxxxxx, XX 00000 Fax (000) 000-0000
9.4. Amendments to Agreement. This Agreement constitutes the
entire Agreement between the Parties hereto on this subject matter and
supersedes all previous arrangements whether
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written or oral. Any amendment or modification of this Agreement shall be
effective only if made in writing, and executed by both Parties.
9.5. 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.
9.6. Relationship of Parties. All purchases and resales of
Licensed Product by BIOPHARM shall be for BIOPHARM's own account as a principal
and not as an agent of ABI. BIOPHARM 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.
9.7. 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.
9.8. Venue and Jurisdiction. Venue of any action brought
under this Agreement shall be as follows: Actions initiated or filed by or
behalf of ABI shall be brought in the federal district court of the Eastern
District of Virginia; and actions initiated or filed by or on behalf of BIOPHARM
shall be brought in the federal district court for the Northern District of
Texas, Amarillo Division.
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9.9. Governing Language. The English language of this
Agreement shall govern and control any translations of the Agreement into any
other language. Documents furnished by BIOPHARM 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: BIOPHARM:
--- --------
AMARILLO BIOSCIENCES, INC. BIOPHARM FOR SCIENTIFIC RESEARCH AND
DRUG INDUSTRY DEVELOPMENT
By: //signature on file// By: //signature on file//
----------------------- -----------------------
Xxxxxx X. Xxxxxxx, Xxxxx Xxxxxx,
Chairman & CEO Chairman & CEO
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EXHIBIT "A"
This Exhibit "A" is attached to that certain License Agreement by and between
AMARILLO BIOSCIENCES, INC. and BIOPHARM FOR SCIENTIFIC RESEARCH AND DRUG
INDUSTRY DEVELOPMENT and its affiliates dated April 25, 2000, and constitutes a
part of said Agreement, as if fully set forth therein.
ABI will supply to BIOPHARM either bulk finished lozenges or bulk interferon-a
and anhydrous maltose 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:
$**** per lozenge
Bulk interferon-a/anhydrous maltose:
$**** per Dose
**** Indicates that a portion of the text has been omitted and filed separately
with the Commission
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