SUPPLY AGREEMENT FOR ANIMAL HEALTH
EXHIBIT
10.54
SUPPLY
AGREEMENT FOR ANIMAL HEALTH
THIS
AGREEMENT is made and effective this 20th day of March, 2008, by and
between AMARILLO BIOSCIENCES, INCORPORATED, a Texas corporation with its
principal place of business at 0000 Xxxxxxxx Xxxx Xxxxx, Xxxxxxxx, Xxxxx 00000
XXX (hereinafter “ABI”) and CytoPharm, Inc., (“CYTO”), a corporation, having a
principal place of business at 0 X Xx. 0, Xxxxxxxxx Xxxx, Sec. 1, Wugu Shiang,
Taipei County 248, Taiwan, (ABI and CYTO collectively referred to hereinafter as
the “Parties”).
WHEREAS,
ABI has substantial expertise in the production and use of HBL interferon
(hereinafter defined) and has proprietary rights and know-how in the field of
production, purification, formulation and use of HBL
interferon.
WHEREAS,
ABI and CYTO now desire to promote applications of technology relating to the
oral administration of HBL interferon in the swine, cattle and poultry species
and CYTO desires to use, formulate, test, and market oral dosage forms
of HBL interferon for treatment of diseases and other healthcare
applications of swine, cattle and poultry in the Territory (hereinafter
defined);
WHEREAS,
CYTO has expressed willingness to pay all costs related to gaining regulatory
approval in Taiwan and China but desires ABI's assistance with study design,
protocol preparation, regulatory affairs and management of clinical
trials.
NOW,
THEREFORE, for and in consideration of the mutual covenants contained herein,
CYTO and ABI agree as follows:
1
ARTICLE
I
DEFINITIONS
1.01. “Agreement” means this Supply
Agreement.
1.02. “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, “control” means ownership
either directly or indirectly of at least forty percent (40%) of the shares of
stock entitled to vote for the election of directors. By way of
explanation but not limitation, Cyto Biotech, is an Affiliate of
CYTO.
1.03. “Anhydrous Crystalline Maltose or
“ACM” means a maltose crystalline powder that is obtained from highly
purified maltose by additional dehydration by heating.
1.04. “Animal
Dose(s)” means the approved dosage of HBL IFNα in International Units
(IU) per unit dose to be used in the animal species which dosage
shall be determined by the testing to be funded by CYTO.
1.05. “bulk
HBL interferon” means HBL IFNα provided in a concentrated form for use in
the manufacture of formulations for use in the Licensed
Species.
1.06. “Commercially Reasonable
Efforts” means, unless the Parties agree otherwise, those efforts
consistent with the exercise of prudent scientific and business judgment, as
applied to other products of similar scientific and commercial potential within
the relevant product lines of the Parties.
1.07 “HBL Agreement” means the Joint
Development and Manufacturing/Supply Agreement by and between HBL and ABI dated
as of March 13, 1992, [as amended by the First Amendment to Joint Development
and Manufacturing/Supply Agreement
2
dated as
of January 17, 1996 and the Addendum to Manufacturing/Supply Agreements dated as
of May 10, 1996 and September 7, 2001].
1.08. “HBL interferon” means the natural human
interferon-alpha (“IFNα”) used by HBL for the formulation of natural
IFNα-containing formulation(s) for use in the treatment of human
renal cell carcinoma and hepatitis B in Japan, presently under the
manufacturing and commercializing approval of the Ministry of Health
and Welfare in Japan, and which is produced by HBL. HBL interferon is
provided for use in the manufacture of formulations for use in the Licensed
Species.
1.09. “Licensed Species” means swine,
cattle and poultry.
1.010. “Net Sales” means the invoice
amounts actually received for sales of the Product by CYTO, its Affiliates or
sub-licensees in a bona fide arm's length transaction, less the following items,
provided that they are bona fide transactions designed to optimize the sales of
Product (a) cash discounts and trade allowances actually granted, (b) rebates
and charge backs required by Applicable Laws or made pursuant to agreements with
customers, (c) credits or allowances actually granted upon claims, damaged
goods, outdated goods, rejections or returns of such Product, including recalls,
(d) taxes, tariffs and similar obligations, duties or other governmental charges
(other than income taxes and inventory taxes) levied on, absorbed or otherwise
imposed on sales of such Product in the Territory and shown separately on the
invoice, (e) shipping charges, and (f) insurance costs related to
shipping.
1.11. “Other Interferon” means any
interferon not provided by HBL that is formulated with ACM to treat Licensed
Species.
3
1.12. “Product” means a
formulation or composition containing both ACM and HBL IFN, Other Interferon
formulated with ACM, or other products formulated by CYTO based on the above
product and designated for oral use in the Licensed Species.
1.13. “Technical Information” means
all information, reports, results, inventions, licenses, know-how,
improvements, materials, and any other technical and scientific data,
specifications and formulae directly related to development,
regulatory approval, manufacture, testing, use, marketing and/or sale of HBL
interferon, and any non-public information relevant to the business of the
Parties which is necessarily disclosed by one to the other during the Parties'
performance under this Agreement. “ABI Technical Information”
refers to Technical Information originating with ABI or which ABI has
developed or has obtained through its contractual relationships with third
parties including HBL. “CYTO Technical Information” refers to
Technical Information originating with CYTO or which CYTO will develop or has
developed or has obtained through its contractual relationships with third
parties. “Technical Information” when not otherwise
specified herein means both ABI Technical Information and CYTO
Technical Information.
1.14. “Territory” means the countries
of Republic of China (“Taiwan”) and People’s Republic of China
(“China”).
ARTICLE
II
RESEARCH
AND DEVELOPMENT
2.01. ABI
Obligations. Subject to the terms and conditions of this
Agreement, ABI shall supply ACM, bulk HBL interferon and ABI Technical
Information for the manufacture, use, formulation, testing and/or marketing
of oral dosage forms involving the stabilization and
4
delivery
of HBL IFN in ACM, for use in the Licensed Species in the Territory, exclusively
to CYTO for such use, and to no other persons or entities. Such oral
dosage forms shall be subject to resale or other distribution by CYTO to other
persons or entities for use, formulation, testing, and/or marketing;
provided, however, that CYTO shall not resell or otherwise distribute such oral
dosage forms or HBL interferon and ACM to other persons or entities for
formulation, testing and/or marketing by such other persons or entities without
first obtaining ABI's written approval, which approval shall not be unreasonably
withheld. ABI shall supply ACM and bulk HBL interferon for
delivery to CYTO f.o.b. HBL's manufacturing facilities, or for
delivery at other locations by agreement of the Parties, packaged in bulk, and
such product shall be supplied in response to issuance by CYTO of written
purchase orders delivered to ABI specifying the quantity to be supplied,
along with any special instructions/requests regarding the supply and/or
delivery of the product.
2.02. CYTO Obligations. CYTO will
use Commercially Reasonable Efforts to timely complete at the sole cost and
expense of CYTO (i) clinical trials and
development of Product for the treatment of the Licensed Species, (ii) animal toxicology and other pre-clinical
studies required for commercial launch of the Product, and
(iii) other tasks supporting
commercialization of the final formulation of the Product.
(a) CYTO
shall use Commercially Reasonable Efforts to timely secure any and all
Governmental Approvals in the Territory and shall own and maintain all
Governmental Approvals and related information as provided herein. The Parties
agree and acknowledge that Governmental Approval for the Product will be sought
in The Territory.
5
(b) The
foregoing notwithstanding, it shall be conclusively presumed that CYTO has not
used “Commercially Reasonable Efforts” as to a particular Licensed Species, if
(i) CYTO fails to commence clinical trials for that species within one (1) year
of the Effective Date; or (ii) CYTO fails to achieve commercial sales for that
species within two (2) years of the Effective Date. If CYTO fails to
enroll a species in a clinical trial within twelve (12) months or fails to
achieve commercial sales for that species within two (2) years, CYTO shall lose
the rights under this Agreement for that particular species, but not for other
species for which CYTO has used Commercial Reasonable Efforts.
(c) CYTO
shall maintain records in sufficient detail and in good scientific manner
appropriate for patent and regulatory purposes and shall properly reflect all
work done and results achieved in the performance of its duties hereunder
(including all data in the form required to be maintained under any Applicable
Laws), and any subsequent pre-clinical or clinical studies (the “Clinical
Records”). The Clinical Records generated in the Territory shall be owned by
CYTO and shall be considered Confidential Information of CYTO and
ABI. ABI may request the Clinical Records, and CYTO shall provide the
Clinical Records to ABI, subject to applicable laws and
regulations. These records include books, records, reports, research
notes, charts, graphs, comments, computations, analyses, compilations,
recordings, photographs, computer programs and documentation thereof, computer
information storage means, samples of materials and other graphic or written
data generated in connection with CYTO's research and development activities
with respect to the Product.
6
(d) In the
event ABI requests that more than 1,000 pages be copied in connection with the
foregoing, ABI shall reimburse CYTO for CYTO’s actual out of pocket costs for
making copies in excess of 1,000 pages. ABI shall pay CYTO such
amounts within 30 days following ABI’s receipt of an invoice therefor
accompanied by documentation reasonably supporting such invoice.
(e) ABI has the right, upon fifteen business days’
prior written notice to CYTO, to review the Clinical Records associated with
CYTO’s activities under this Agreement during normal business hours, and CYTO
shall, subject to Applicable Laws, provide ABI upon request with a copy of all
requested Clinical Records, at ABI’s cost, to the extent reasonably required for
the exercise of ABI's rights under this Agreement. ABI may use the Clinical Records and the summaries thereof for
commercial and regulatory approval purposes. If ABI wants to provide a
non-governmental entity Third Party with the Clinical Records or a summary
thereof or use information contained in such records for a commercial purpose,
ABI may do so as long as the non-governmental entity Third Party agrees to the
Confidentiality provisions of Article VIII.
2.03. Availability of Resources;
Cooperation. Each Party shall maintain laboratories, offices and/or other
facilities reasonably necessary to carry out the activities to be performed by
such Party hereunder. Upon reasonable advance notice, each Party agrees to make
its employees and non-employee consultants reasonably available at their
respective work locations to consult with the other Party on issues arising
during the collaboration and in connection with any request from any
Governmental Authority, including regulatory, scientific, technical and clinical
testing issues. Such meeting may be arranged through the internet or
site visit. The meetings should be arranged within 15 working days after the
requests, where feasible.
2.04. Reporting Obligations of CYTO.
On or prior to December 31st of each year during the TERM of this Agreement CYTO
shall provide ABI with a report of ongoing development efforts, including a
report of efforts by CYTO with respect to clinical testing, regulatory approval
efforts, marketing/sales strategy, and any other areas into which CYTO'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 samples of labeling, instructions, promotional and other support materials,
if any, developed for CYTO's sales force, patients, physicians, or other outside
parties.
ARTICLE
III
3.01. License and Supply
Grant. Subject to the terms of this Agreement and the Existing
Licenses, ABI hereby grants to CYTO:
(a) an
exclusive sublicense, under the ABI Technology to use the ABI Technology to
market, advertise, promote, manufacture, offer for sale, sell, and distribute
the Product in the Territory; and
(b) an
exclusive sublicense, under all rights granted to ABI pursuant to the HBL
Agreement to market, advertise, promote, manufacture, offer for sale, sell, and
distribute the Product in the Territory.
3.02. Restrictions. CYTO shall have
the right to use and sell Product only in the Territory and only for use in the
Licensed Species. . CYTO shall not seek customers, establish any branch or
maintain any distribution depot for Product in any country outside the
Territory. CYTO
shall not
sell Product to any customer in any country outside the Territory or to any
customer in the Territory if, to the knowledge of CYTO, such customer intends to
resell such Product in any country outside the Territory.
|
ARTICLE
IV
|
|
PAYMENTS
AND ROYALTIES
|
4.01. Initial
Fee. On the Effective Date, as an initial license fee, CYTO
shall pay to ABI a sum equal to Thirty Thousand US Dollars
($30,000). This fee will be wired into ABI’s designated bank account
within 30 days of the Effective Date. Failure to make this initial paymentshall
cause the Agreement to be terminated and to be of no further force or effect
(except for Article XV). Upon receipt of the initial license fee, ABI
shall provide CYTO with All the existing regulatory documents in ABI’s
possession that are needed to obtain government approval for trials in China and
Taiwan. ABI shall request HBL transfer the technologies and
manufacturing processes for mixing concentrated IFNα
and ACM to CYTO; and CYTO will utilize such technologies and processes solely
for the purpose of mixing interferon with ACM. After ABI notifies CYTO in
writing or by e-mail of supplying documents above and completes the transfer of
technologies and manufacturing processes, CYTO will wire into ABI’s designated
bank account an additional thirty thousand dollars ($30,000) within 30
days.
7
4.04. Minimum Sales. CYTO shall meet
or exceed the following annual minimum sales. If CYTO does not
achieve these levels, ABI will have the right to terminate the
Agreement. Year 1 means the first 12 months after regulatory approval
is obtained.
Year
1 $0.5
million
Year
2 $1.5
million
Year 3
and beyond $4.0 million
8
4.05. Reports. CYTO
shall furnish to ABI a quarterly written report, which report shall contain at a
minimum (a) the number of interferon and ACM sold; (b) the calculation of Net
Sales; (c) royalties payable in U.S. dollars, if any, which shall have accrued
hereunder based upon Net Sales; (d) withholding taxes, if any, required by law
to be deducted with respect to such sales; (e) the dates of the First Commercial
Sale of any Product; and (f) the exchange rates, if any, used to determine the
amount of United States dollars (collectively, the “Royalty Statement”). Reports
shall be due on the 45th day
following the close of each quarter.
9
fails to
remit the payment within thirty (30) days, interest at a rate equal to the Prime
Rate of Interest shall be imposed starting from the 31st
day. If such accounting firm concludes that such payments were
overpaid during such period, ABI shall pay to CYTO the amount of any such
overpayments, without interest, within thirty (30) days of the date ABI delivers
to CYTO such accounting firm's report so concluding that such payments were
overpaid. If ABI fails to remit payment within 30 days, interest at a rate equal
to the Prime Rate shall be imposed starting from the 31st
day. Provisions in this Section 4.06 requiring either Party to pay
interest shall not prevent the other Party from immediately taking all actions
necessary to collect all amounts due, or to enforce any other remedy under this
Agreement. ABI shall bear the full cost of such audit unless such
audit discloses an underpayment by more than 5% of the amount due during such
period. In such case, CYTO shall bear the full cost of such audit. CYTO shall
provide ABI a copy of the CYTO audited financial statements with sufficient
detail to show the portion of revenue from HBL interferon sales and Other
Interferon formulation with ACM sales each year to be delivered to ABI within 3
months of the end of CYTO’s fiscal year.
10
4.10. CYTO
shall pay ABI for Bulk HBL Interferon $10/million IU plus $30/kilogram for ACM
plus the amount of any future HBL price increases to ABI.
4.11. CYTO
shall remit to ABI payment in U.S. funds via wire transfer to a bank account of
ABI’s choice. Fifty percent (50%) of the payment will accompany the
purchase order with the balance to be paid within 15 days of the date CYTO
accepts delivery at HBL’s factory or warehouse in Japan.
11
ARTICLE
V
WARRANTIES
ABI makes
no warranty, express or implied, and all implied warranties or warranties
of merchantability and fitness for a particular purpose are hereby
disclaimed and excluded. HBL warrants to ABI in the HBL Agreement
that Manufactured Products delivered to ABI, its Affiliates, or Sub licensees
shall conform to all specifications listed on the Product Specification Sheet(s)
for said Manufacture Product(s) at the time of its delivery, provided that HBL
shall be compensated separately for any packaging or labeling performed at the
request of ABI. It is understood that HBL makes no other warranties
of merchantability and fitness for a particular purpose which are beyond the
aforesaid stated warranty obligations are hereby disclaimed and
excluded.
ARTICLE
VI
DISCLAIMERS AND
INDEMNIFICATION
6.01. ABI
makes no representation or warranty that the manufacture or sale of
Manufactured Products will not infringe any third party patent, nor does ABI
assume any obligations with respect to infringements of patents of others
arising as a result of CYTO's activities under this Agreement except as
otherwise expressly provided in this Agreement.
6.02. ABI
makes no covenant either to defend any infringement charge by a third party
or to initiate action against infringers of any of its patents except as
otherwise expressly provided in this Agreement.
6.03. ABI
makes no representation or warranty concerning the potential profitability
of sales of Product and shall not be liable for failure of licensee to obtain a
profit or income from such sales.
12
6.04.
ABI SHALL NOT BE DEEMED TO HAVE MADE ANY REPRESENTATION OR WARRANTY AS TO
THE CONDITION, MERCHANTABILITY, DESIGN, FUNCTION OR FITNESS FOR
USE OF PRODUCTS.
6.05. CYTO
agrees that it shall indemnify and save ABI harmless from any and all claims,
demands, actions and causes of action against ABI, whether groundless or not, in
connection with any and all injuries, losses, damages or liability of
any kind whatsoever, arising, directly or indirectly, out of the use,
distribution, and/or sale of Product by or through CYTO. ABI shall
notify CYTO in writing within ten (10) days of its receipt of any claim, demand
or lawsuit. Upon assumption by CYTO of its duty to defend, CYTO will
have control of the claim, demand or lawsuit, and except as may be
necessary to prevent lapse of its legal rights, ABI shall be required to
incur no expense with regard to said claim, demand or lawsuit. ABI
shall, at CYTO's request, provide reasonable assistance in defense of
any such claim, demand or lawsuit.
ARTICLE
VII
TERM OR TERMINATION;
DEFAULT
7.01. Unless
sooner terminated as hereinafter provided, this Agreement shall remain
in effect for a period of ten (10) years from the date of this
Agreement. After said initial term, the Agreement shall be
automatically renewed for successive one (1) year terms subject to the
prior written agreement of the Parties (hereinafter called “Renewal
Terms”).
7.02. If
CYTO shall at any time during the initial term or any subsequent Renewal Term of
this Agreement default in any obligation hereunder or fail to pay any payment
due, and such default shall not be cured within sixty (60) days after written
notice from ABI to CYTO specifying the nature of the default, ABI may terminate
this Agreement, or may demand specific performance. Failure
to conduct clinical trials in swine in the USA and China within twelve (12)
months of the execution of this Agreement shall be cause for termination without
notice.
13
7.03. If
ABI shall, at any time during the initial term or any subsequent Renewal Terms
of this Agreement, default in any obligation hereunder other than a default
caused by HBL and such default shall not be cured within sixty (60) days after
written notice from CYTO to ABI specifying the nature of the default, CYTO may
terminate this Agreement, or may demand specific
performance. If a default is caused by HBL, ABI will make its
best efforts to influence HBL to cure the default.
7.04. Any
termination pursuant to this Article shall not relieve ABI of any obligation to
fill purchase orders placed with ABI prior to termination.
7.05. The
exercise by either Party of any right of termination shall not constitute a
waiver of any other rights or remedies available to such party for violation of
the terms of this Agreement or under applicable law.
ARTICLE VIII
CONFIDENTIALITY
8.01. ABI
owns or is licensed under confidential or secret information relating
to HBL interferon-containing products and the use of same in the Licensed
Species, and it is the intention of ABI to maintain this
confidentiality.
8.02. CYTO
possesses trade secrets and technical and marketing information that are
proprietary to CYTO, and it is its intention to maintain the confidentiality of
its proprietary information.
14
8.03. Each
Party agrees to maintain confidential and secret all information which may
be disclosed or provided to it by the other Party and that the Parties may
together subsequently acquire in relation to interferon-containing products
and which is designated in writing by clearly identifiable legend as being
confidential or secret in character.
8.04. 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 confidential information, when the recipient Party can
demonstrate that such item of information:
8.04.1.
Is publicly known and available through some means other than by the recipient
Party's act or omission; or
8.04.2.
Was in the recipient Party's possession prior to its disclosure by the
other Party, provided that written evidence of such possession is
established; or
8.04.3. 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.
8.05. Neither
Party will permit confidential or secret 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 confidential or secret information and/or documents with
the same precautions it uses to safeguard its own confidential or secret
information.
8.06. Each
Party will notify the other promptly if it has knowledge that a third party
possesses confidential or secret information of the other Party related to
interferon-containing products.
15
8.07. CYTO
shall have the right to use ABI's confidential or secret information
to the extent reasonably necessary to accomplish the objectives of this
Agreement, including specifically the right to disclose such information to
its Affiliates, actual and potential purchasers or transferees, third-party
contract consultants and scientific investigators (from whom CYTO shall secure
Confidential Disclosure Agreements) and to regulatory agencies in support of
applications for regulatory agency approval to make, test and/or sell HBL
interferon-containing products.
ARTICLE
IX
BOOKS
AND RECORDS
9.01. CYTO
shall keep proper books of accounts which clearly indicate the volume of sales
and all other financial data and documentation associated with sales of
oral interferon. CYTO shall provide ABI a copy of the CYTO audited
financial statements with sufficient detail to show the portion of revenue from
sales of Product in Licensed Species each year to be delivered to ABI at the
earliest possible date within 3 months after the end of CYTO’s fiscal
year.
9.02. ABI
may nominate an independent public accountant, acceptable to and approved by
CYTO (which approval shall not be unreasonably withheld), once in each calendar
year, to inspect the books of account of CYTO and other records and reports
deemed reasonably necessary for inspection by said accountant during reasonable
business hours for the purpose of verifying the accuracy of the reports and
payments made by CYTO during the preceding calendar year. Such
accountant shall not disclose any information related to CYTO's financial
matters but shall certify to ABI the accuracy of the reports and payments made
by CYTO in accordance with
16
this
Agreement. All fees charged by such accountant shall be paid by ABI
except if there are discrepancies in CYTO's reports, which result in under
reporting or under payment by a factor greater than 10% of the amount
due. In such instance CYTO shall reimburse ABI for the accountant's
costs other than as required by law. ABI shall not make any public
disclosure of the CYTO reports or payments referred to in this
agreement. To the extent disclosure of such information to a third
party is required in the ordinary course of ABI's business, such disclosure
shall be made subject to the recipient's agreement to hold such information in
confidence.
ARTICLE
X
MISCELLANEOUS
10.01. Survival. ARTICLES
VII, VIII, and IX shall survive any termination of this Agreement.
10.02. Force Majeure. The
failure of CYTO, ABI, or any of their Affiliates to take any act required
by this Agreement if occasioned by an act of God or the public enemy, fire,
explosion, earthquake, 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 circumstance now exists or hereafter arises, shall not subject either
Party to any liability to the other.
10.03. Arbitration. The
Parties hereto desire to avoid and settle without litigation future disputes
which may arise between them relative to this Agreement. Accordingly,
the Parties
17
agree to
engage in good faith negotiations to resolve any such dispute. In the
event they are unable to resolve any such dispute by negotiation, such
dispute shall be submitted to arbitration as follows: If arbitration is
initiated by CYTO, it shall be held in the State of Texas, U.S.A. in compliance
with the Commercial Arbitration Rules of the American Arbitration
Association. If arbitration is initiated by ABI, it shall be
held in Taiwan in compliance with the Commercial Arbitration Rules of the
Arbitration Association of Taiwan. The arbitration award shall be
final and binding upon the Parties hereto and may be filed with and enforced by
any competent court of competent jurisdiction to enforce said
award. If arbitration is initiated by ABI for failure to pay for HBL
interferon, Bulk HBL interferon or ACM, it shall be held in Japan in compliance
with the Rule of the Japan Commercial Arbitration Association.
10.04. Communication. Any
payment, notice or other communication required or permitted to be made or
given to either Party hereto 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 an overnight courier service, postage or delivery charge
prepaid, or by telex or telefax addressed to it at its address set forth, or to
such other address(es) as it may designate by written notice given to the other
Party as follows:
In case of
ABI: Xx.
Xxxxxx X. Xxxxxxx, Chairman & CEO
Amarillo
Biosciences, Inc.
0000
Xxxxxxxx Xxxx Xxxxx
Xxxxxxxx,
XX 00000
Facsimile:
(000) 000-0000
With a copy
to: Xxxxxx
X. Xxxxxx, Legal Counsel
SandersBaker,
PC
000 X.
Xxxx, Xxx. 000
Xxxxxxxx,
XX 00000
Facsimile:
(000) 000-0000
18
In case of
CYTO: Xx.
Xxxxxx Chen, Chairman of Board of Directors
CytoPharm,
Inc.,
6 F Xx.
0, Xxxxxxxxx Xxxx, Xxx. 0
Xxxx
Xxxxxx, Xxxxxx Xxxxxx 248
Taiwan
Telephone:
x000-0-00000000
10.05. Amendments to
Agreement. This Agreement constitutes the entire
agreement between the Parties hereto with respect to all of the matters herein
addressed, and supersedes all previous arrangements whether written or oral,
covering the same subject matter. Any amendment or modification
of this Agreement shall be effective only if made in writing, and executed by
both Parties.
10.06. Assignment. This
Agreement shall not be assignable by CYTO to any person or entity other than a
CYTO Affiliate without the prior written consent of ABI. This
Agreement shall not be assignable by ABI to any person or entity other than an
ABI Affiliate without the prior written consent of CYTO.
10.07. Enforceability. If
one or more of the provisions of this Agreement shall be held to be
invalid, illegal or unenforceable, the validity, legality or
enforceability of the remaining provisions hereof shall not in any way
be affected or impaired thereby. 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.
10.08. Nature of
Relationship. Nothing herein shall be construed to place the
Parties in a relationship of partners or joint venturers, nor does this
Agreement make either party the agent or legal representative of the other for
any purposes whatsoever. The Parties further
19
agree
that no representation shall be made by either party that would create an
apparent agency, employment, partnership or joint
venture. Neither party shall have the power express or implied, to
obligate or bind the other in any manner whatsoever.
10.09.
Headings. The
headings of the several sections of this Agreement are inserted for convenience
of reference only and are not intended to be a part of or to affect the meaning
or interpretation of this Agreement.
10.10. Waiver. No
provision of this Agreement shall be deemed waived, unless such waiver is
in writing and signed by the Party against which the waiver is sought to be
enforced. The waiver by either of the Parties hereto of any
breach of any provision hereof by the other Party shall not be construed to be
either a waiver of any succeeding breach of any such provision or a waiver of
the provision itself.
10.11. Governmental Approval. In the
event ABI has to obtain the approval from the appropriate governmental
authorities of Japan to deliver HBL interferon to the country in which CYTO
will use and/or market HBL interferon or products containing HBL
interferon, ABI's obligation pertaining to the supply of the said product
to the said country shall be subject to such approval granted in writing to HBL
or ABI.
10.12.
No Third-Party
Beneficiaries. This Agreement contemplates no third-party
beneficiaries, and no person or entity, other than the Parties or their
permitted assignees, shall have any rights whatsoever under this
Agreement.
20
IN
WITNESS WHEREOF, the Parties hereunto have caused this Manufacturing/Supply
Agreement to be executed in duplicate by their duly authorized
representatives as of the date first above written.
ABI: CYTO:
AMARILLO
BIOSCIENCES,
INC. CYTOPHARM,
INC.
By: /s/
Xxxxxx X.
Xxxxxxx By: /s/
Xxxxxx X. Xxxx
Xx.
Xxxxxx X.
Xxxxxxx Xx.
Xxxxxx X. Xxxx
President
and
CEO
Chairman of the Board of Director
21
