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EXHIBIT 10.36
LICENSE AGREEMENT
THIS LICENSE AGREEMENT ("Agreement") is made and effective
this 1st day of February, 2000, by and between MOLECULAR MEDICINE RESEARCH
INSTITUTE (hereinafter "MMRI") , 000 Xxxx Xxxxxxxxxxx Xxxx, Xxxxxxxx Xxxx,
Xxxxxxxxxx 00000 (hereinafter "MMRI") and AMARILLO BIOSCIENCES, INCORPORATED, a
Texas corporation, with its principal place of business at 000 X. 0xx, Xxxxxxxx,
Xxxxx 00000 (hereinafter "ABI") (MMRI and ABI are hereinafter collectively
referred to as the "Parties").
WHEREAS, XXXXXX X. XXXXXX and XXXXXX X. XXXXXXX are
co-inventors of that certain provisional United States Patent Application No.
60-156,480, dated September 28, 1999, relating to a method for using
interferon-g ("IFN-g") orally, and which, along with all modifications,
revisions, continuations, continuations-in-part, divisions, re-issues,
extensions, or foreign counterparts thereof, is hereinafter referred to as the
"Patent" or "Patents";
WHEREAS, ABI has already conducted or contracted for the
conduct of preliminary tests demonstrating the efficacy of orally administered
IFN-g in several species;
WHEREAS, ABI and its contract suppliers have substantial
expertise in the production and use of IFN-g and have proprietary rights and
know-how in the field of production, purification and formulation of IFN-g;
WHEREAS, XXXXXX X. XXXXXX has heretofore assigned all of his
assignable rights in the Patent to MMRI, and XXXXXX X. XXXXXXX has heretofore
assigned all of his assignable rights in the Patent to ABI;
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WHEREAS, MMRI and ABI have ongoing research programs and
product development efforts directed to the use of IFN-g in both human and
animal medicine and desire to expand use of IFN-g to new human and animal
applications;
WHEREAS, ABI desires to acquire a license under the Patent and
a license of MMRI Technical Information for the use and sale of IFN-g-containing
formulations for oral use to treat or prevent diseases in humans and animals;
WHEREAS, MMRI is willing to disclose to ABI MMRI Technical
Information including preliminary animal and human data;
WHEREAS, MMRI is desirous of conducting research on
applications of IFN-g to human and animal health;
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
MMRI agree as follows:
ARTICLE I
DEFINITIONS
1.1. "ABI" and "MMRI" shall mean and include not only the
indicated company, but also such company's Affiliates and 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.
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1.3. "Agreement" or "License Agreement" means this
Agreement and all Exhibits hereto.
1.4. "Assignee" means any permitted assignee of rights
under this Agreement.
1.5. "Invention" means all inventions described in the
Patent.
1.6. "Licensed Product" means dose formulations or
compositions containing any animal or human IFN-g designated, detailed or
labeled for oral use including, but not limited to, administration for mucosal
contact of the mouth and throat to treat or prevent the development of
infections in humans or animals exposed to infectious agents, or suffering from
autoimmune diseases, cancer, or connective tissue diseases.
1.7. "Net Sales Value" shall mean the gross selling price
paid to ABI or its Affiliates by any purchaser of Licensed Product from ABI or
its Affiliates, for Licensed Product, less all packaging, instructional, or
other similar charges, and less customary trade discounts and refunds or credits
allowed for return of defective Product. If Licensed Production is sold in
transactions which are not bona fide arms-length transactions, Net Sales Value
for such sales shall be valued as equal to commercial sales of similar products
to unrelated third parties in similar quantities.
1.8. "Sublicensee" means an entity to which ABI hereafter
licenses the Patent or rights under the Patent, and which entity assumes the
primary responsibility for development of a Licensed Product.
1.9. "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 or other interferon-containing compositions, and any
non-public information
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relevant to the business of the Parties which is necessarily disclosed by one to
the other during the Parties' conduct under this Agreement. "MMRI Technical
Information" refers to Technical Informa tion originating with MMRI or which
MMRI has obtained through its contractual relationships with third parties. "ABI
Technical Information" refers to Technical Information originating with ABI or
which ABI has obtained through its contractual relationships with third parties.
"Technical Information" when not otherwise specified herein means both MMRI
Technical Information and ABI Technical Information.
ARTICLE II
THE LICENSE GRANT
MMRI grants to ABI, subject to the terms of this Agreement, a
royalty-bearing, exclusive license under the Patent and under MMRI Technical
Information to make, have made, or use Licensed Product labeled for testing or
trials, and upon proper regulatory approval, for use and sale to treat humans or
animals in the United States.
ARTICLE III
CONSIDERATION
3.1. ABI shall pay to MMRI a royalty of ten percent (10%)
of all amounts received by ABI or an ABI Affiliate from a Sublicensee or
Sublicensee Affiliate, which amounts are based on sales of Licensed Product.
3.2. The parties acknowledge that a Sublicensee may
require from ABI the license of one or more patents other than the Patent;
accordingly, if one or more patents other than the Patent are licensed to a
Sublicensee with respect to the development of Licensed Product, the royalty set
forth above as payable by ABI to MMRI shall be reduced as follows: for the first
such additional
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Patent, the royalty provided in Section 3.1 shall become eight percent (8%); for
the second, six percent (6%); and for the third or any additional such Patent,
four percent (4%). Under no circumstances shall this Section 3.2 cause the
royalty provided under Section 3.1 to be reduced below four percent (4%).
3.3. If ABI does not license the Patent or rights under
the Patent to a Sublicensee, but conducts commercial sales of Product either
directly, or through an Affiliate or one or more distributors, then in lieu of
the consideration set forth in Section 3.1 above, ABI shall pay to MMRI a
royalty of five percent (5%) of the Net Sales Value of Licensed Product sold by
ABI or its Affiliates, as the case may be.
ARTICLE IV
REMITTANCES, RECORDS AND REPORTS
4.1. ABI shall keep accurate records in sufficient detail
to enable the royalties and any other amounts payable hereunder to be
determined. MMRI shall have the right to nominate an independent public
accountant or firm of MMRI choice ("auditors") to audit such records. Once in
each calendar year, the auditors shall have access to the records of ABI
relating to payments under this Agreement during reasonable business hours for
the purpose of verifying the accuracy of the reports and payments made during
the current year and/or any preceding calendar year. The matters to be audited
shall include sales volumes, deliveries, prices, receipts, and all other matters
constituting verification of the royalty payable to MMRI hereunder.
4.2. Payment of royalties shall be made to MMRI within
forty (40) days following the end of each calendar quarter for all amounts
received by ABI or an ABI Affiliate either from direct sales or from a
Sublicensee or Sublicensee Affiliate or from a distributor during said quarter,
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and royalties to MMRI shall accrue when such amounts are received by ABI or an
ABI Affiliate. All payments to MMRI shall be accompanied by statements certified
by an officer of ABI which give sufficient information from which to calculate
the amount of payment due hereunder, including the total quantity and price of
Licensed Products sold by ABI, ABI Affiliates, Sublicensees, or distributors for
which royalty has accrued during the preceding quarter, and the aggregate
amounts payable to MMRI. A statement shall also be submitted in the event that
no amounts are payable to MMRI.
4.3. Payments hereunder shall be made in U.S. Dollars in
the United States and royalties shall accrue in U.S. Dollars.
ARTICLE V
TERM AND TERMINATION
5.1. This Agreement and all rights licensed hereunder by
MMRI to ABI shall terminate upon the expiration of the Patent, or if there
should be one or more foreign counterparts, upon the expiration of the last
expiring Patent.
5.2. In the event ABI shall at any time fail to make
payments, render reports, or otherwise fail to abide by the terms of this
Agreement, MMRI may notify ABI in writing of such default and MMRI's intent to
terminate this Agreement unless such default is cured by ABI within sixty (60)
days from receipt by ABI of such notice. If such default is not cured within the
sixty (60) day period, MMRI may provide ABI with written notice of termination,
and this Agreement and the license and rights granted by it shall thereupon
terminate.
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5.3. Termination of this Agreement for any reason shall
not relieve the Parties of any obligation accruing prior to such termination. In
addition, ARTICLE IX ("Confidentiality") shall survive termination of this
Agreement.
5.4. Any accrued royalties or other payments shall be paid
to MMRI within thirty (30) days of the termination of this Agreement.
ARTICLE VI
OBLIGATION TO DEVELOP
ABI shall endeavor to enter into an agreement with a
development partner (Sublicensee) providing for the development of Licensed
Product, and will make reasonable commercial efforts to cause such agreement to
provide for $300,000 in research funding to be committed to MMRI ($100,000 per
year, over a three-year period) for research related to the development of a
Licensed Product. The other provisions of this Agreement notwithstanding,
including without limitation the term and termination provisions contained in
Article V above, if ABI has not executed an agreement with a development partner
(Sublicensee) within three (3) years of the date of this Agreement, providing
for the reasonable and timely development of a Licensed Product, under which the
development partner has undertaken to conduct appropriate and required
preclinical studies and initiation of clinical trials to obtain regulatory
approval, and to take other steps toward the commercialization of a Licensed
Product, then this Agreement shall thereupon terminate, and neither party shall
have any continuing obligation to the other; or alternatively, at the sole
election of MMRI, MMRI may, by written notice delivered to ABI, undertake the
task of finding a development partner (Sublicensee), and shall have three (3)
years from the inception of such undertaking to secure agreement with a
development partner. In the event such an agreement is
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secured, the terms of this Agreement shall apply to such arrangement, but with
ABI considered to be the licensor, with MMRI considered to be the licensee, and
with all terms and conditions of this Agreement applying to such new
arrangement. At all times during the term of this License Agreement, both
parties shall act cooperatively in seeking a development partner or a
Sublicensee, and both parties shall have full access to all data and other
intellectual property in the possession of the other relating to Licensed
Product, subject to the confidentiality provisions of Article IX, below. Nothing
herein shall be construed to require ABI to license any patent other than the
Patent to MMRI, or to require ABI to license any other intellectual property
rights to MMRI, or to prevent ABI from developing and marketing, simultaneous
with MMRI, one or more Licensed Products, as long as such do not infringe the
Patent.
If MMRI should find a development partner or Sublicensee
pursuant to the procedures hereinbefore set forth, ABI shall be granted the
first right to attempt to negotiate an IFN-g supply agreement with such
development partner or Sublicensee.
ARTICLE VII
PATENT APPLICATIONS, OWNERSHIP, AND ENFORCEMENT
The enforcement of any and all patents licensed hereunder,
including without limitation the prosecution of any lawsuits to enforce the
Patent shall be at the sole discretion of ABI; provided, however, that if MMRI
should request such enforcement, and advance all funds necessary to enforce such
patents (including without limitation legal fees and expenses) and indemnify ABI
against any loss, cost or expense arising from such enforcement action, then ABI
shall use its best efforts to enforce such patents.
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ARTICLE VIII
DISCLAIMERS AND INDEMNIFICATION
8.1. ABI makes no representation or warranty that the sale
of Licensed Product 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 ABI's activities under this Agreement.
8.2. ABI makes no covenant to defend any infringement
charge by a third party, nor, except as otherwise herein expressly provided, to
initiate action against infringers of the MMRI Patent.
8.3. Neither ABI nor MMRI makes any representation or
warranty concerning the potential profitability of sales of Licensed Product.
8.4. ABI agrees that it shall indemnify and save MMRI
harmless from any and all claims, demands, actions and causes of action against
MMRI, 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, manufacture, distribution and/or sale of Licensed
Product by or through ABI or its Affiliates or Sublicensees, whether or not the
claims, demands, actions or causes of action are alleged to have resulted in
whole or in part from the negligent acts or omissions of MMRI, or from acts or
omissions of persons for which MMRI is or would otherwise be strictly liable.
This indemnification obligation shall include, without limiting the generality
of the foregoing, reasonable attorneys' fees and other costs or expenses
incurred in connection with the defense of any and all such claims, demands,
actions or causes of action.
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ARTICLE IX
CONFIDENTIALITY
9.1. ABI and MMRI own or are licensed under confidential
or secret information relating to the Invention, and it is the intention of ABI
and MMRI to maintain this confidentiality.
9.2. 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.
9.3. 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:
9.3.1. Is publicly known and available through some
means other than by the recipient Party's act or omission; or
9.3.2. 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
9.3.3. 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.
9.4. 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.
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9.5. Each Party will notify the other promptly if it has
knowledge that an unauthorized third party possesses Technical Information of
the other Party related to the Invention.
9.6. ABI shall have the right to use MMRI's Technical
Information to the extent reasonably necessary to accomplish the objectives of
this Agreement, including specifically the right to disclose such information to
its contract consultants and scientific investigators (from whom ABI shall
secure Confidential Disclosure Agreements) and to United States regulatory
agencies in support of applications for regulatory agency approval to make, test
and/or sell Licensed Product.
ARTICLE X
MISCELLANEOUS
10.1. Force Majeure. The failure of ABI, MMRI, 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.
10.2. 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 fax or by certified or registered mail or by
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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:
In case of ABI:
Xx. Xxxxxx X. Xxxxxxx
000 X. 0xx
Xxxxxxxx, Xxxxx 00000
Fax: 806/000-0000
In case of MMRI:
Xx. Xxxxxx X. Xxxxxx
Molecular Medicine Research Institute
000 Xxxx Xxxxxxxxxxx Xxxx
Xxxxxxxx Xxxx, XX 00000
Fax: 000-000-0000
10.3. 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.
10.4. Assignment. In the event of a merger, consolidation
or other reorganization under which, by operation of law, another surviving
company succeeds to the rights and obligations of ABI, then such surviving
company shall be and become fully substituted herein, as if originally a party
hereto. In addition, ABI may assign its rights under this Agreement to a
corporate Affiliate of ABI. Otherwise, this Agreement shall not be assignable by
either ABI or MMRI without the prior written consent of the other. This
Agreement shall inure to the benefit only of the parties hereto, their permitted
Assignees, and their legal successors.
10.5. 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
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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.
10.6. Venue and Applicable Law. This Agreement shall be
interpreted and enforced in accordance with the laws of the State of Texas,
U.S.A., and any action brought by either party to enforce or construe this
Agreement, or for damages hereunder, shall be brought in a court of appropriate
jurisdiction (state or federal, as the case may be) in Potter County, Texas,
U.S.A.
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: MMRI:
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AMARILLO BIOSCIENCES MOLECULAR MEDICINE RESEARCH
INCORPORATED INSTITUTE
By: //signature on file// By: //signature on file//
----------------------------------------------------- ----------------------------------------------------
Xx. Xxxxxx X. Xxxxxxx, President and Xx. Xxxxxx X. Xxxxxx, Director and
Chairman of the Board Chairman of the Board
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