LICENSE AGREEMENT
This LICENSE AGREEMENT (the "Agreement") is made as of this 1st day of
November, 1996, by and between the Arizona Board of Regents, acting for and on
behalf of The University of Arizona, Xxxxxx, Xxxxxxx 00000 ("LICENSOR"), and
IgX Corp., a Delaware corporation having a principal address at 00000 Xxxxx
Xxxxxx Xxxx Xxxxx, Xxxxx 000, Xxxxxxx, Xxxxxxxx 00000 ("IgX").
WHEREAS, LICENSOR represents that F. Xxxxxx Xxxxxxxx, M.D., Ph.D., an
employee of LICENSOR, is the inventor (the "Inventor") who has submitted to
LICENSOR the following disclosures (each of which are attached as Exhibit "A"
hereto and a portion of which constitute the "INVENTION" as defined in Exhibit
"A"): (i) UA1524, Therapeutic Monoclonal IgA Antibodies to Cryptosporidium
Antigens of 500KDa and Less Than 1,000KDa; (ii) UA1525, Anti-GP23 Antigen
Monoclonal IgA Antibodies for Treatment of Cryptosporidiosis, G9H4 and H8H2
and (iii) UA1526, Monoclonal IgA Antibody 1B8 Directed to Cryptosporidium
200KDa Antigen;
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 mutual covenants and promises
contained herein, IgX and LICENSOR agree as follows:
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."
INVENTION shall be defined to also include any patent applications filed by
IgX in the name of F. Xxxxxx Xxxxxxxx, M.D., Ph.D., as well as any and all
rights, modifications, derivatives and/or enhancements arising therefrom or
relating thereto (collectively, the "Patent Rights"). INVENTION(S) hereunder
shall be limited to devices, processes, compositions or products for treatment
of human patients, and shall specifically exclude any devices, processes,
compositions or products for treatment of animals within the field of
veterinary science.
1.2. "LICENSED PRODUCT(S)" shall mean monoclonal antibodies or treatments
derived from the INVENTION as described in Exhibit "A" that are within the
FIELD OF USE, as defined in Paragraph 1.5.
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 therapeutic use within each country in the
world.
1.5. "FIELD OF USE" shall mean the use of the INVENTION for
REGULATOR-approved human therapeutics in the treatment of cryptosporidiosis in
humans. FIELD OF USE shall be defined to also include any and all proposed
uses derived from and/or relating to the Patent Rights. Notwithstanding the
foregoing, the FIELD OF USE hereunder shall be limited to devices, processes,
compositions or products for treatment of human patients, and shall
specifically exclude any devices, processes, compositions or products for
treatment of animals within the field of veterinary science.
1.6. "FIRST COMMERCIAL SALE" means the initial transfer by IgX or its
SUBLICENSEE(S) 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 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 percent (50%) of the voting
stock, or at least fifty percent (50%) interest in the income of such
corporation or other business.
-3-
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 during the term of any extension thereof, unless
sooner terminated as herein provided (the "License"). LICENSOR also grants to
IgX under the terms of the 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) ("SUBLICENSEE(S)"). IgX shall promptly
notify LICENSOR in writing at the time of each sublicense ("SUBLICENSE") 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) as provided for in Section 3.1
below.
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 effective as of the
execution of this Agreement, and shall be for an initial term of twenty (20)
years from the date of the FIRST COMMERCIAL SALE, and said License shall be
renewable for two additional ten (10) year periods at the discretion of IgX,
subject to the provisions of Articles 4 and 5 of this Agreement.
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
-4-
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 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
sale 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 that
three percent (3%) of the net sales of such LICENSED PRODUCT(S).
-5-
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.
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 PRODUCTS(S) in the FIELD OF USE and
shall report such efforts in accordance with the provisions of Paragraph 3.4.
IgX agrees to support the Research Plan attached hereto as Exhibit "B," which
describes the work yet to be done by LICENSOR 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, IgX 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 PRODUCTS(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.
-6-
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 trustee, 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.
5.2. Notwithstanding the provisions of Paragraph 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 SUBLICENSE(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 not be assigned by either party without the prior
written consent of the other party; provided, however, that IgX may assign
this Agreement to any AFFILIATE of IgX, or to any purchaser or transferee of
all or substantially all of IgX's business upon prior written notice to
LICENSOR. LICENSOR agrees not to assign any of its rights or obligations under
this Agreement to any other party without first obtaining IgX's written
approval.
6.2. 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
representatives of the parties, except as provided for in Paragraph 5.1.
-7-
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 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.
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. The parties agree that any dispute arising under this Agreement
involving the sum of Thirty Thousand Dollars ($30,000) or less in money
damages only shall be resolved by arbitration pursuant to the Arizona Uniform
Rules of Procedure for Arbitration. The decision of the arbitrator(s) shall be
final.
10. INDEMNIFICATION
10.1. IgX agrees to indemnify and hold harmless 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 IgX'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 for and on behalf of LICENSOR may be dependent upon the
appropriation of funds by the State Legislature of Arizona. Should the
Legislature fail to appropriate the necessary funds or if LICENSOR's
appropriation is reduced during the fiscal year, the Arizona
-8-
Board of Regents may reduce the scope of this Agreement if appropriate or
cancel this Agreement without further duty or obligation. The Arizona Board of
Regents agrees to notify other party(ies) as soon as reasonably possible after
the unavailability of said funds comes to its attention.
13. CONFLICT OF INTEREST
13.1. This Agreement is subject to Arizona Revised Statutes ' 38-511 and
the State of Arizona may cancel this Agreement if any person significantly
involved in negotiating, drafting, securing or obtaining this Agreement for or
on behalf of the Arizona Board of Regents becomes an employee in any capacity
of any other party or a consultant to any other party with reference to the
subject matter of this Agreement while the Agreement or any extension hereof
is in effect.
14. GENERAL
14.1. IgX shall not use the name of the Inventor, or any institution with
which he has been or is connected, or the adaption of any of them, in any
advertising, promotional or sale 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 Corp.
00000 Xxxxx Xxxxxx Xxxx Xxxxx, Xxxxx 000
Xxxxxxx, Xxxxxxxx 00000
With a copy to: June Knaudt
IgX Corp.
c/o: Xxxxx & Co.
0000 Xx Xxxxx Xxxxxxx Xxxxx, Xxxxx 000
Xxx Xxxxx, Xxxxxxxxxx 00000
To LICENSOR: Xxxxx X. Xxxxxxx, Director
Sponsored Projects Services
The University of Arizona
000 Xxxxx Xxxxxx Xxxxxx, #000
P.O. Box 210158
Tucson, Arizona 85721-0158
With a copy to: Xxxx X. Xxxxx, Ph.D., Director
Office of Technology Transfer
-9-
The University of Arizona
000 Xxxxx Xxxxxx Xxxxxx, #000
P.O. Box 210158
Tucson, Arizona 85721-0158
and F. Xxxxxx Xxxxxxxx, M.D., Ph.D.
Associate Professor
Department of Veterinary Science
The University of Arizona
Building 90, Room 202
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 as 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 Inventor may freely publish and disseminate the TECHNICAL
INFORMATION in any manner he may choose and may furnish LICENSED PRODUCT(S) to
interested other parties for non-commercial, research oriented purposes. The
Inventor will inform any such other party that LICENSOR has an exclusive
Agreement with IgX.
14.8. This Agreement may be executed in more than one counterparts, each
of which shall be deemed an original, but all of which together shall
constitute one and the same instrument. This Agreement may be executed by
facsimile and such facsimile copy shall be conclusive evidence of the consent
and ratification of the matters contained herein by the undersigned.
-10-
150 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 supersedes
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.
[Remainder of Page Intentionally Left Blank]
-11-
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed
by their duly authorized representatives as of the day and the year first
written above.
LICENSOR: Arizona Board of Regents, acting for and
on behalf of The University of Arizona
By:/s/ Xxxxx X. Xxxxxxx
------------------------------
Name:
----------------------------
Title: Director
--------------------------
IgX: IgX Corp.,
a Delaware corporation
By:/s/ Xxxxxx X. Xxxxx
------------------------------
Xxxxxx X. Xxxxx, Chairman
The undersigned has read and understands the terms and conditions of this
Agreement, and by his signature below accepts and will abide by said terms and
conditions.
/s/ F. Xxxxxx Xxxxxxxx, M.D., Ph.D.
------------------------------------
F. Xxxxxx Xxxxxxxx, M.D., Ph.D.
-12-
EXHIBIT "A"
INVENTION
EXHIBIT "B"
RESEARCH PLAN
