LICENSE AGREEMENT
This Agreement is made this 27th day of May 1992 by and between the Arizona
Board of Regents on behalf of The University of Arizona (LICENSOR) having a
principal office at Administration 601, The University of Arizona, Xxxxxx,
Xxxxxxx 00000, and IgX ("IgX"), a Delaware corporation having a principal
address at 00000 X. Xxxxxx Xxxx Xxxxx, Xxxxxxx, XX 00000 (hereinafter "IgX").
WITNESS THAT:
WHEREAS, LICENSOR represents that Xxxxxxxxx X. Cama, Graduate Student, and
Xxxxxxx X. Xxxxxxxx, Ph.D., employees of LICENSOR, are The Inventors who have
disclosed an invention, Hyperimmune Egg Yolks as a Source of
Anti-Cryptosporidium Neutralizing Antibodies Suitable for Passive Immune
Transfer (the INVENTION), to LICENSOR, which disclosure (attached hereto as
Exhibit A) was assigned log number UA1121; and
WHEREAS, LICENSOR has the right to make, use, sell, and grant licenses under
the INVENTION as defined herein; and LICENSOR wishes to have the INVENTION
utilized for the public interest; and
WHEREAS IgX wishes to obtain a license to make, use, sell, and distribute the
INVENTION under the FIELD OF USE (as defined herein) and upon the terms and
conditions hereinafter set forth;
NOW, THEREFORE, in consideration of the premises and faithful performance of
the covenants contained herein, IT IS AGREED:
1. "DEFINITIONS"
For the purposes of this Agreement, and solely for that purpose, the terms
hereinafter set forth shall be defined as follows:
1.1. "INVENTION" shall mean the invention as described in EXHIBIT A.
1.2. "LICENSED PRODUCT(S)" shall mean hyperimmune hen egg yolks containing
anti-Cryptosporidium antibodies derived from the INVENTION as described in
EXHIBIT A.
1.3. "TECHNICAL INFORMATION" shall mean technical information and know-how
relating to the preparation of LICENSED PRODUCT(S).
1.4. "REGULATOR" shall mean the government approved regulatory body,
committee, agency, or other organization which by law has the power to approve
the sale of the INVENTION for human or veterinary therapeutic use within each
country in the world.
1.5. "FIELD OF USE" shall mean the use of INVENTION for REGULATOR approved
human therapeutics in the treatment of cryptosporidiosis in patients with
Acquired Immune Deficiency Syndrome (AIDS) and in certain immune competent
patients.
1.6. "FIRST COMMERCIAL SALE" means the initial transfer by IgX or its
Sublicensees of LICENSED PRODUCT(S) in exchange for cash or some equivalent to
which value can be assigned for the purpose of determining NET SALES.
1.7. "NET SALES" means the total gross receipts for sales of LICENSED
PRODUCT(S) by IgX, its Sublicensee(s) or its AFFILIATES, and from leasing,
renting, or otherwise making LICENSED PRODUCT(S) available to others without
sale or other dispositions, whether invoiced or not, less returns and
allowances actually granted, freight out, taxes or excise duties imposed on
the transaction (if separately invoiced), and wholesaler and cash discounts in
amounts customary in the trade. No deductions shall be made for commissions
paid to individuals, whether they be with independent sales agencies or
regularly employed by IgX or its AFFILIATES, and on their payroll, or for the
cost of collections.
1.8. "NET SALES PRICE" means the NET SALES divided by the quantity of
LICENSED PRODUCT(S) sold. In the event that the LICENSED PRODUCT(S) is sold as
part of a kit, or in combination with other products not covered by this
Agreement (such as detection systems), the NET SALES PRICE for such products
which contain the LICENSED PRODUCT(S) will be calculated as B * (A/B); where A
is the gross sales price of an equivalent unit of LICENSED PRODUCT(S) sold
separately, less allowances, and B is the gross sales price of the kit or
combination of products in which the LICENSED PRODUCT(S) is included less
allowances.
1.9. "AFFILIATE" means any corporation or other business entity controlled
by, controlling, or under common control with IgX. For this purpose, "control"
means direct or indirect beneficial ownership of at least fifty (50) percent of
the voting stock, or at least fifty (50) percent interest in the income of such
corporation or other business.
2. LICENSE
2.1. LICENSOR hereby grants to IgX and IgX hereby accepts from LICENSOR,
upon the terms and conditions herein specified, an exclusive, worldwide, and
non-assignable (except as herein specified) License under the INVENTION to test,
evaluate, and develop the LICENSED PRODUCT(S) in the FIELD OF USE covered hereby
and to make, have made, use and sell the LICENSED PRODUCT(S) during the term of
this Agreement, and
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during the term of any extension thereof, unless sooner terminated as herein
provided. LICENSOR also grants to IgX under the terms of this License the right
to use the TECHNICAL INFORMATION to test, evaluate, and develop the LICENSED
PRODUCT(S).
2.2. LICENSOR hereby grants to IgX and IgX hereby accepts from LICENSOR,
upon terms and conditions herein specified, the right to extend the License
granted hereunder to its SUBLICENSEE(S). IgX shall promptly notify LICENSOR in
writing at the time of each SUBLICENSEE and shall provide LICENSOR with a copy
of each SUBLICENSE. IgX may negotiate such terms as it chooses for each
SUBLICENSE, provided that LICENSOR shall receive a royalty for all sales made by
SUBLICENSEE(S) at a rate not less than that provided for in this Agreement and
fifty percent (50%) of any additional amounts received by IgX from SUBLICENSEE.
2.3. If IgX shall so notify LICENSOR in advance thereof in writing, any
SUBLICENSEE(S) to whom the License shall have been extended pursuant to
paragraph 2.2 hereof, may make the reports and royalty payments specified in
Paragraph 3.1 hereof, directly to LICENSOR on behalf of IgX; otherwise, such
reports and payments on account of sales by such SUBLICENSEE(S) shall be made by
IgX.
2.4. LICENSOR retains a non-exclusive, royalty-free, irrevocable License
to make, have made and use the INVENTION and LICENSED PRODUCT(S) for its own
use.
2.5. The exclusive License of paragraph 2.1 shall be for a term of twenty
(20) years from FIRST COMMERCIAL SALE, said license shall be renewable for two
ten (10) year periods at the discretion of IgX.
2.6. Outside the scope of the License between LICENSOR and IgX no other,
further, or different license of right, and no further power to sublicense is
hereby granted or implied.
3. ROYALTIES, RECORDS AND REPORTS
3.1. During the term of this Agreement, unless sooner terminated, IgX
shall pay to LICENSOR, in the manner hereinafter provided, earned royalties at
the rate of five percent (5%) of the NET SALES PRICE of all LICENSED PRODUCT(S)
sold by IgX and its SUBLICENSEE(S), anywhere in the world.
3.2. LICENSED PRODUCT(S) shall be considered sold when sold or invoiced,
and if not sold or invoiced, when delivered to a third party.
3.3. IgX shall be responsible for the performance hereunder of all
obligations including payment of royalties, keeping of records, and reporting
by IgX and any
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SUBLICENSEE(S) to whom the License shall have been extended pursuant to this
Agreement.
3.4. So long as this Agreement remains in force, IgX shall deliver to
LICENSOR, within sixty (60) days after the first day of January, April, July
and October of each year, a true and accurate report, giving such particulars
of the business conduct by IgX and its SUBLICENSEE(S) during preceding three (3)
months under this Agreement as are necessary to accurately account for sales
subject to royalties under this Agreement. Each report shall include, but not be
limited to, information about production, inventory on hand, marketing efforts
and sales.
3.5. Simultaneously with the delivery of each report required by the
preceding paragraph 3.4, IgX shall pay to LICENSOR the net royalties and any
other such payment due under this Agreement for the period covered by such
report. If no royalties are due, it shall be so reported.
3.6. All payments from IgX to LICENSOR shall be in U.S. dollars. The rates
of exchange for such payments shall be midpoint between the buying and selling
rates for U.S. dollars as quoted by the Chase Manhattan Bank in New York, New
York at the close of business on the last business day preceding the date
payment is due.
3.7. In case of any delay in payment by IgX to LICENSOR not occasioned by
force majeure, interest at the rate of one percent (1%) per month, assessed from
the thirty-first (31st) day after the due date of said payment, shall be due by
IgX without special notice.
3.8. Royalties shall accrue in accordance with this Agreement, upon the
FIRST COMMERCIAL SALE.
3.9. Royalties payable in connection with the sale of a LICENSED PRODUCT(S)
under Paragraph 2.2 and Paragraph 3.1 shall be reduced by an amount of royalties
actually paid by IgX or such SUBLICENSEE(S) to any non-affiliated third party in
connection with the licensing of additional patent rights or know-how necessary
to make, use, or sell LICENSED PRODUCT(S); provided, however, that in no event
shall the Royalties payable to LICENSOR be less than three percent (3%) of the
net sales of such LICENSED PRODUCT(S).
3.10. IgX shall keep full, true and accurate books of account containing
all particulars which may be necessary for the purpose of showing the amount
payable to LICENSOR by way of royalty as aforesaid or by way of any other
provision hereunder. Said books of account shall be kept at IgX's principal
place of business. Said books and supporting data shall be open at all
reasonable times, for three (3) years following the end of the calendar year to
which they pertain, to inspection by LICENSOR for the purpose of verifying IgX's
royalty statements, or IgX's compliance in other respects with this Agreement.
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3.11. IgX also agrees to make a written report to LICENSOR within ninety
(90) days after the date of termination of this agreement, stating in such
report the number, description, and NET SALES of all products made, sold, or
otherwise disposed of and upon which royalties are payable hereunder but which
were not previously reported to LICENSOR. IgX shall also continue to make
quarterly reports pursuant to the provisions of paragraph 3.4 of all gross
income received from leasing, renting, or otherwise making products available to
others without sale or other disposition transferring title in the case of
transactions entered into prior to such termination.
4. PERFORMANCE
4.1. IgX shall use its best efforts to commence and maintain regular
commercial production and sale of LICENSED PRODUCT(S) in the FIELD OF USE and
shall report such efforts in accordance with the provisions of Paragraph 3.4.
The licensee agrees to support the attached research plan and budget, Exhibit
"B", which describes the work yet to be done by the LICENSOR between May 25,
1992 and June 1, 1993 to further develop the invention for IgX, so that IgX
might identify further actions which may be necessary to achieve regulatory
submission and approval to make the first commercial sale. At the end of this
period, but no later than eighteen (18) months from the date of this agreement,
LICENSEE will provide a milestone schedule of development and licensed products
and regulatory submission. This time period may be extended by mutual agreement
of both parties.
4.2. IgX and LICENSOR agree to cooperate to ensure the quality of LICENSED
PRODUCT(S) before LICENSED PRODUCT(S) are first offered for sale in a commercial
transaction and periodically thereafter. IgX shall provide samples of LICENSED
PRODUCT(S) so that LICENSOR can determine through mutually agreed upon
laboratory protocols the activity of LICENSED PRODUCT(S). In the event LICENSED
PRODUCT(S) supplied by IgX are not active or are otherwise defective, IgX and
LICENSOR will cooperate to produce active LICENSED PRODUCT(S) and/or to correct
any defects in the LICENSED PRODUCT(S). If for any reason IgX does not maintain
activity and/or correct defects in LICENSED PRODUCT(S), LICENSOR has the right
to take action under the provisions of Paragraph 5.2 of this Agreement.
5. TERMINATION
5.1. If IgX shall become bankrupt or insolvent and/or if the business of
IgX shall be placed in the hands of a Receiver, Assignee, or Trusteee, whether
by voluntary act of IgX or otherwise, this License will be deemed to have
automatically terminated as of a date seven (7) days prior to that event,
provided, however, that such termination shall not terminate any obligations
which may have accrued prior thereto.
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5.2. Notwithstanding the provisions of Article 5.1, upon any breach or
default under this Agreement by IgX, LICENSOR may terminate this License by
ninety (90) days written notice by registered mail to IgX. Said notice shall
become effective at the end of said period, unless during said period IgX shall
cure any breach or default and notify LICENSOR thereof.
5.3. IgX may terminate this license at any time upon ninety (90) days
written notice by registered mail to LICENSOR.
5.4. Upon termination of this License for any reason, all rights granted
hereunder shall revert to LICENSOR for the sole benefit of LICENSOR.
5.5. Termination of this License shall terminate all SUBLICENSEE(S) made
by IgX hereunder, at the option of LICENSOR.
5.6. IgX's responsibilities and obligations to report to LICENSOR and pay
royalties to LICENSOR as to any LICENSED PRODUCT(S) produced or sold by IgX or
its SUBLICENSEE(S) under this Agreement prior to termination or expiration
hereof shall survive such termination or expiration.
6. ASSIGNMENT
6.1. This Agreement may be assigned by LICENSOR. This Agreement may be
assigned by IgX to the successor of its entire business, or to any wholly-owned
subsidiary, but shall not be otherwise assignable by IgX without the written
consent of LICENSOR.
6.2. Successors and Assigns: All of the terms, covenants and conditions of
this Agreement shall be binding upon and inure to the benefit of and shall apply
to the respective heirs, executors, administrators, successors, assigns and
legal representation of the parties, except as provided for in Paragraph 5.1.
7. SEVERABILITY
7.1. Should any part or provision of this Agreement be unenforceable or
otherwise in conflict with or in violation of the law of any jurisdiction, the
remainder of this Agreement shall remain binding upon the parties.
8. NEGATION OF WARRANTIES
8.1. Nothing in this Agreement shall be construed as a warranty or
representation
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that anything made, used, sold or otherwise disposed of under any license
granted in this Agreement is or will be free from infringement of patents of
third parties; or
8.2. LICENSOR makes no representation other than those specified in
this
Agreement. LICENSOR makes no express or implied warranties of merchantability
or fitness for any particular purpose of LICENSED PRODUCT(S).
9. ARBITRATION
9.1. Any controversy arising under or related to this Agreement, and any
disputed claim by either party against the other under this Agreement, shall be
settled by arbitration in accordance with the Licensing Agreement Arbitration
Rules of the American Arbitration Association. Upon request of either party,
arbitration will be by:
(a) A third party arbitrator mutually agreed upon in writing by
IgX and LICENSOR within thirty (30) days of arbitration request; or
(b) A member of the American Arbitration Association.
9.2. Any arbitration under Section 9.1 shall be held in such a place as
may be mutually agreed upon in writing between the parties and judgment upon the
award rendered by the arbitrator may be entered by any court having jurisdiction
thereof.
10. INDEMNIFICATION
10.1. IgX agrees to indemnify and hold harmless the LICENSOR, LICENSOR's
employees or agents from and against any and all claims, damages and liabilities
asserted by third parties, both government and private, arising from COMPANY's
sale of LICENSED PRODUCT(S) to ultimate consumers and their use thereof, except
that IgX shall not indemnify LICENSOR, LICENSOR's employees or agents for any
claims, damages or liability resulting from the negligence of any of them.
11. NONDISCRIMINATION
11.1. The parties agree to be bound by applicable state and federal rules
governing equal employment opportunity and nondiscrimination.
12. STATE OBLIGATION
12.1. The parties recognize that the performance by the Arizona Board of
Regents
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for and on behalf of the University of Arizona may be dependent upon the
appropriation of funds by the State Legislature of Arizona. Should the
Legislature fail to appropriate the necessary funds, the Board of Regents may
cancel this Agreement without further duty or obligation. The Board agrees to
notify other party(ies) as soon as reasonably possible after the unavailability
of said funds comes to the Board's attention.
13. CONFLICT OF INTEREST
13.1. This Agreement is subject to the provisions of A.R.S. (Section)
15-1635.01 and A.R.S. (Section) 38-511. The Governor or the State of Arizona may
cancel this Agreement by written notice to the parties if any person
substantially involved in obtaining, drafting or procuring this Agreement for or
on behalf of the Arizona Board of Regents becomes an employee or consultant in
any capacity of IgX, unless all requirements stipulated in A.R.S. Section
15-1635.01 have been met.
14. GENERAL
14.1. IgX shall not use the name of The Inventors, or any institution with
which they have been or are connected, or the adaptation of any of them, in any
advertising, promotional or sales literature, without prior written consent
obtained from LICENSOR in each case.
14.2. Any notice required or permitted to be given by this Agreement shall be
given postpaid first class certified mail; unless otherwise stated:
TO IgX: Xxxxxx X. Xxxxx, Chairman
IgX Corporation
c/o Henry & Co.
0000 Xxxxx Xxxxxx Xxxxx
Xxx Xxxxx, XX 00000
TO LICENSOR: Vice President for Research
Administration 601
The University of Arizona
Xxxxxx, Xxxxxxx 00000
with a copy to:
Xxxx X. Xxxxx, Ph.D.
Director
Office of Technology Transfer
University of Arizona
0000 Xxxx Xxxx Xxxxxx, Xxxxx 000
0
Xxxxxx, Xxxxxxx 00000
Such addresses may be altered by written notice. If no time limit is specified
for a notice required or permitted to be given under this Agreement, the time
limit shall be twenty (20) full business days, not including the day of
mailing.
14.3. This Agreement, and its effect, is subject to and shall be construed in
accordance with the laws of the State of Arizona.
14.4. The parties to this Agreement recognize and agree that each is
operating an independent contractor and not as an agent of the other.
14.5. The captions herein are for convenience only and shall not be deemed
to limit or otherwise affect the construction thereof.
14.6. Any waiver by either party of the breach of any term or condition of
this Agreement will not be considered as a waiver of any subsequent breach of
the same or any other term or condition hereof.
14.7. The Inventors may freely publish and disseminate the TECHNICAL
INFORMATION in any manner they may choose and may furnish LICENSED PRODUCT(S)
to interested other parties for non-commercial, research oriented purposes.
The Inventors will inform any such other party that LICENSOR has a
co-exclusive Agreement with IgX and with one other party under which The
Inventors furnish hybridomas for commercial purposes.
15. ENTIRE AGREEMENT
15.1. This Agreement sets forth the entire Agreement and understanding
between the parties as to the subject matter of this Agreement, and merges all
prior discussions between them. Neither of the parties shall be bound by any
conditions, definitions, warranties, or representations with respect to the
subject matter of this Agreement or as duly set forth on or subsequent to the
date hereof in writing unless signed by the proper and duly authorized
representative of the party to be bound thereby.
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IN WITNESS WHEREOF, the parties hereto have hereunto set their hands and duly
executed this Agreement as of the day and the year first above written.
Arizona Board of Regents
on behalf of
University of Arizona
By [illegible]
--------------------------------
Title
------------------------------
Date
-------------------------------
IgX
By /s/ Xxxxxx X. Xxxxx
--------------------------------
Title Chairman
------------------------------
Date May 27, 1992
-------------------------------
Inventors have read and understood the terms and conditions of this Agreement
and by their signatures below accept said terms and conditions.
/s/ Xxxxxxxxx X. Cama /s/ Xxxxxxx X. Xxxxxxxx
----------------------------------------- ---------------------------------
Xxxxxxxxx X. Cama Xxxxxxx X. Xxxxxxxx
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