RESEARCH AGREEMENT
This RESEARCH AGREEMENT (the "Agreement") is made effective as of the
1st day of July, 1996 by and between the Arizona Board of Regents acting for
and on behalf of The University of Arizona, Xxxxxx, Xxxxxxx 00000 (hereinafter
"UNIVERSITY") and IgX Corp., a Delaware corporation (hereinafter "IgX"),
having a principal address at 00000 Xxxxx Xxxxxx Xxxx Xxxxx, Xxxxx 000,
Xxxxxxx, Xxxxxxxx 00000.
WHEREAS, IgX desires UNIVERSITY to perform certain research work as
summarized in the abstract appended hereto as Exhibit "A" and made part
hereof, Preclinical Evaluation of Anti-Cryptosporidium parvum Monoclonal
Antibodies for Passive Immunotherapy of Cryptosporidiosis in Humans (the
"Research Plan" hereafter), based in part on University of Arizona Invention
Disclosure UA1411, Monoclonal Antibodies Reactive with Multiple
Neutralization-Sensitive Surface Epitopes as a Source of Treatment of Enteric
Cryptosporidiosis in Humans disclosed by Xxxxxxx X. Xxxxx, DVM, Ph.D. (the
"Disclosure" hereafter) and is willing to advance funds to sponsor such
research;
WHEREAS, IgX desires to obtain certain rights to intellectual
property that may be developed during the course of the Research Plan;
WHEREAS, UNIVERSITY is willing to undertake such Research Plan and to
grant IgX an option to obtain rights to such intellectual property;
WHEREAS, the research leading to the Disclosure was supported by the
following grants: National Institutes of Health AI30223 and U.S. Department of
Agriculture NRI 00-00000-0000;
WHEREAS, UNIVERSITY, if applicable, has requested title to the
Disclosure pursuant to Public Law 96-517, applicable regulations relating
thereto as from time to time amended and institutional agreements between
itself and agencies of the U.S. Government;
WHEREAS, UNIVERSITY will acquire title, if any there be, to all
improvements to the Disclosure made using UNIVERSITY facilities by virtue of
Arizona Board of Regents (ABOR) Patent Policy and said Public law, regulations
and agreements; and
WHEREAS, UNIVERSITY is granting to IgX the option to acquire certain
rights to intellectual property related to the FIELD OF RESEARCH (as defined
herein) under the terms and conditions of the License Agreement attached as
Exhibit "B;"
NOW, THEREFORE, in consideration of the mutual covenants and promises
herein contained, IgX and UNIVERSITY agree as follows:
ARTICLE 1. Definitions
1.1 Terms in this Agreement (other than names of the parties and
Article headings) which are set forth in upper case letters have the meaning
established for such terms in the succeeding paragraphs of this Article 1.
1.2 "FIELD OF RESEARCH" shall mean the study of the production of
monoclonal antibodies reactive with multiple neutralization-sensitive surface
epitopes on infective sporozoite and
merozoite stages for the treatment of enteric cryptosporidiosis in immune
compromised human patients and in certain immune competent human patients.
1.3 "SPONSORED RESEARCH" shall mean those research activities to be
performed by UNIVERSITY within the FIELD OF RESEARCH, and in accordance with
the Research Plan as summarized in the attached Exhibit "A."
1.4 "PRINCIPAL INVESTIGATOR" shall mean Xxxxxxx X. Xxxxx, DVM, Ph.D.,
who is employed by UNIVERSITY, and who will have the primary responsibility
for performing and/or supervising the SPONSORED RESEARCH.
1.5 "UNIVERSITY" as used herein shall include, without restriction or
limitation, UNIVERSITY and the PRINCIPAL INVESTIGATOR, and any other employee,
representative or agent of The University of Arizona participating in the
SPONSORED RESEARCH pursuant to this Agreement.
1.6 "INVENTION(S)" as used herein shall include, without restriction
or limitation, any and all devices, processes (including without limitation
processes of using devices or of manufacturing such devices), compositions or
products whether patentable or unpatentable, which are conceived or reduced to
practice during the term of the Agreement and for ninety (90) days after it
expires, which is/are developed as a result of conducting the SPONSORED
RESEARCH for IgX, and which are within the FIELD OF RESEARCH. 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 in connection in
the field of veterinary science.
1.7 "IgX's INVENTION(S)" shall mean those INVENTION(S) independently
conceived or reduced to practice by IgX, with "independently" meaning for the
purpose of this Agreement, the lack of involvement by UNIVERSITY in assisting
or contributing to the conception or reduction to practice of such
INVENTION(S).
1.8 "UNIVERSITY's INVENTION(S)" shall mean all INVENTION(S) made by
UNIVERSITY, PRINCIPAL INVESTIGATOR and other UNIVERSITY employees in direct
performance of the SPONSORED RESEARCH.
1.9 "JOINT INVENTION(S)" shall mean those INVENTION(S) not coming
within the definitions for IgX's INVENTION(S) or UNIVERSITY's INVENTION(S).
ARTICLE 2. Research Activity
2.1 Research Program. The research program which is contemplated by
the Agreement is set forth in the Research Plan attached as Exhibit "A." This
Research Plan sets forth the research tasks and objectives to be performed by
UNIVERSITY and the amount of funding to be provided by IgX. UNIVERSITY agrees
to conduct the SPONSORED RESEARCH in accordance with the Research Plan of
Exhibit "A." The PRINCIPAL INVESTIGATOR may select other employees,
representatives and/or agents of UNIVERSITY to assist with the Research Plan,
provided that such individuals are
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made aware of this Agreement, and in particular, have agreed to be bound by
the terms of this Agreement.
2.2 Independent Contractor. UNIVERSITY, for the purposes of this
Agreement, and for all services to be provided hereunder, shall be deemed to
be an independent contractor and neither the agent nor the employee of IgX.
UNIVERSITY shall not have authority to make any statements, representations or
commitments of any kind, or to take any action, which shall be binding upon
IgX except as provided for herein or authorized in writing by IgX.
2.3 Funding. A budget covering expected costs of the SPONSORED
RESEARCH is included in the attached Exhibit "A." UNIVERSITY agrees that this
budget represents the expected funding for conducting the SPONSORED RESEARCH
pursuant to this Agreement. The SPONSORED RESEARCH is to be funded as the work
is completed based on invoices (in triplicate) submitted by UNIVERSITY. Timely
payment by IgX shall be made upon receipt of such invoices sent to the
following address. Checks should be made payable to The University of Arizona
and should identify the UA account no. 434200.
Sponsored Projects Services
The University of Arizona
000 Xxxxx Xxxxxx Xxxxxx, 510
P.O. Box 210158
Xxxxxx, Xxxxxxx 00000
2.4 Exclusivity of Research. IgX understands that UNIVERSITY may be
involved in similar research through other researchers on behalf of itself and
others. UNIVERSITY shall be free to continue such research provided that it is
conducted separately under funding separate from the Research Plan of Exhibit
"A" and IgX shall not gain any rights via this Agreement to such other
research.
2.5 Personnel Agreements. UNIVERSITY represents that the covenants
set forth in this Agreement shall apply and are binding on any individual
employed to perform the SPONSORED RESEARCH under this Agreement, and
additionally represents that it has agreements with any such individuals
sufficient to satisfy the terms and conditions of this Agreement.
2.6 Compliance with Laws. The PRINCIPAL INVESTIGATOR agrees to comply
with all national and local laws of the jurisdiction wherein he conducts
business, including compliance at all times with Good Laboratory Practice
guidelines as established by the Food and Drug Administration. UNIVERSITY
further agrees that any compensation it receives under this Agreement shall
not be disbursed for any purpose which is unlawful or unethical under those
laws.
2.7 Equipment and Supplies. Any equipment and supplies purchased
under this Agreement to conduct the Research Plan remaining at the end of the
Research Plan shall belong to UNIVERSITY.
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ARTICLE 3. Property Rights
3.1 Property Rights. The parties agree that the following provisions
apply to IgX's INVENTION(S), UNIVERSITY's INVENTION(S) and JOINT INVENTION(S).
a. IgX's INVENTION(S): IgX's INVENTION(S) shall remain the
sole and exclusive property of IgX and UNIVERSITY shall have no title or claim
to such INVENTION(S). IgX shall bear sole responsibility and expense for the
filing and prosecuting of any patent applications concerning such
INVENTION(S).
b. UNIVERSITY's INVENTION(S): UNIVERSITY's INVENTION(S)
shall remain the sole and exclusive property of UNIVERSITY.
i. UNIVERSITY shall bear the sole responsibility and expense
for the filing and prosecuting of any patent application concerning
such INVENTIONS(S). If IgX elects to exercise the option pursuant
to Article 3.1(b)(iii), IgX will reimburse UNIVERSITY for
out-of-pocket costs of filing and prosecuting patent applications
covering UNIVERSITY's INVENTION(S).
ii. If UNIVERSITY declines to file a patent application on
such INVENTION(S), including filing a patent application in a
particular country, then IgX may elect, at its own discretion and
expense, to file and prosecute such patent application, provided,
that such application and any resulting patent shall remain the
sole and exclusive property of UNIVERSITY. In the event that IgX
prepares and files such an application UNIVERSITY hereby agrees to
execute any necessary papers to accomplish preparing, filing and
prosecuting the application.
iii. UNIVERSITY further agrees to grant and hereby grants to
IgX a right of first refusal with respect to UNIVERSITY's
INVENTION(S). To that end, UNIVERSITY agrees to grant and hereby
grants to IgX an exclusive option to acquire a royalty-bearing
exclusive license in any and all UNIVERSITY INVENTION(S) pursuant
to the terms and conditions of the License Agreement substantially
in the form attached hereto as Exhibit "B" to this Agreement. Said
exclusive option shall be exercised in writing by IgX within six
(6) months after notification of such UNIVERSITY INVENTION(S) has
been communicated to IgX pursuant to Section 3.2 below.
c. JOINT INVENTION(S): JOINT INVENTION(S) shall be owned
jointly by IgX and UNIVERSITY, with each party having the full right to
practice the INVENTION(S) subject only to similar rights of the other party.
i. UNIVERSITY and IgX shall mutually agree upon the filing,
including the selection of appropriate countries in which to file,
of patent applications for such JOINT INVENTION(S). The expense for
filing and prosecution of such mutually agreed upon patent
applications shall be shared equally by UNIVERSITY and IgX. If the
parties do not agree upon the filing of a patent application, or do
not agree upon filing an application in a specific country, for a
particular JOINT INVENTION(S), then the party desiring to file such
patent
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application, including the filing in a specific country, may
file at its own expense, provided that any resulting patent shall
become the exclusive property of the filing party free of any
royalty or other payment obligation to the non-filing party.
UNIVERSITY and IgX also agree to equally share in the expense of
maintaining any patent for JOINT INVENTION(S). In the event one
party elects not to pay its share of maintenance costs, then the
other party may at its own expense continue such maintenance,
provided that such patent will become the exclusive property of
that party free of any royalty or other payment obligations to the
other.
ii. In the event that a patent application is prepared, or a
patent is maintained concerning a JOINT INVENTION(S) by one of the
parties pursuant to Article 3.1(c)(i), then the other party hereby
agrees to execute any necessary papers to transfer its interest in
such application or patent to the other party.
iii. Neither IgX nor UNIVERSITY shall have the right to
transfer any interest in such JOINT INVENTION(S) without the prior
written approval of the other party, with such approval not being
unreasonably withheld by either party, except for the interest of
the filing party in a patent application filed by that party
pursuant to Article 3.1(c)(i).
iv. UNIVERSITY further agrees to grant, and hereby grants to
IgX an exclusive option to acquire a royalty-bearing exclusive
license to UNIVERSITY'S interest in any and all JOINT INVENTION(S)
pursuant to the terms and conditions of the License Agreement
substantially in the form attached hereto as Exhibit "B" to this
Agreement. Said exclusive option shall be exercised in writing by
IgX within six (6) months after notification of such JOINT
INVENTION(S) has been communicated to IgX pursuant to Section 3.2
below.
3.2 Disclosure of INVENTION(S). UNIVERSITY agrees to disclose through
its Office of Technology Transfer to IgX each such UNIVERSITY's INVENTION(S)
and JOINT INVENTION(S) within thirty (30) days of determining the existence of
such INVENTIONS(S). UNIVERSITY further agrees to notify IgX within ninety (90)
days of disclosure of each UNIVERSITY's INVENTION(S) of its decision on filing
of an appropriate patent application, whereupon IgX may, if UNIVERSITY
declines to file an application or fails to properly notify IgX, elect to file
such an application pursuant to Article 3.1(b)(ii).
ARTICLE 4. Publication
4.1 UNIVERSITY and the PRINCIPAL INVESTIGATOR have the right to
publish or otherwise publicly disclose information gained in pursuing the
Research Plan supported by this Agreement. In order to avoid loss of patent
protection as a result of public disclosure on information developed during
the Research Plan, UNIVERSITY will submit any materials to IgX for review at
least thirty (30) days before submission of materials for publication or
before making presentations. IgX shall notify UNIVERSITY within sixty (60)
days of receipt of such materials:
a. Whether IgX desires to file patent applications on any
intellectual property contained in the materials that may be subject to patent
protection; or
b. Whether such materials contain information the public
disclosure of which
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would be commercially prejudicial to IgX.
4.2 IgX shall have the right to request that any commercially
prejudicial information be deleted from the materials submitted or the
portions thereof be rewritten to be less prejudicial; provided, however, that
the PRINCIPAL INVESTIGATOR shall have final authority to determine the scope
and content of any publication.
ARTICLE 5. Confidential Information
5.1 IgX and UNIVERSITY may wish, from time to time, in connection
with work contemplated under this Agreement, to disclose confidential
information to each other. IgX and UNIVERSITY shall use reasonable efforts to
prevent the disclosure of any confidential information belonging to the other
to third parties, and use such information only for the purposes expressed in
this Agreement and for a period of three (3) years thereafter, provided that
the receiving party's obligation hereunder shall not apply to information
that:
a. Is already in the receiving party's possession at the time
of disclosure thereof;
b. Is or later becomes part of the public domain through no
fault of the receiving party;
c. Is received from a third party having no obligation of
confidentiality to the disclosing party;
d. Was prior to disclosure independently developed by the
receiving party; or
e. Is required to be disclosed by law or under regulation.
ARTICLE 6. Publicity
6.1 Except as required by law, no press release or other written
statements in connection with work performed under this Agreement intended for
use in the public media, having or containing any reference to IgX or
UNIVERSITY shall be made by either party without approval of the other party,
which approval shall not be unreasonably withheld. UNIVERSITY, however, shall
acknowledge IgX's support of the Research Plan under this Agreement in
scientific publications and other scientific communications. In any other
statements, the parties shall describe the scope and nature of their
participation accurately and appropriately.
ARTICLE 7. Arbitration
7.1 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.
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ARTICLE 8. Term and Termination of Agreement
8.1 The Research Plan shall be commenced by UNIVERSITY on or about
July 1, 1996 and shall continue for an initial period of eighteen (18) months.
Extensions of this initial eighteen-month period shall be as mutually agreed
to in writing signed by the parties.
8.2 Notwithstanding the foregoing, performance under this Agreement
may be terminated by IgX upon sixty (60) days written notice; performance may
be terminated by UNIVERSITY if circumstances beyond its control preclude
continuation of the Research Plan. Upon receipt of notice of termination from
IgX, UNIVERSITY will proceed in an orderly fashion to terminate any
outstanding commitments and to close down the Research Plan. In the event that
this Agreement is terminated by IgX, all costs associated with termination
will be reimbursable to UNIVERSITY including costs incurred prior to the
receipt of notice of termination but which have not yet been reimbursed, and
commitments existing at the time notice of termination is received which
cannot be canceled. IgX shall not reimburse UNIVERSITY for costs associated
with termination of this Agreement by UNIVERSITY. In the event of termination,
UNIVERSITY will provide IgX with a final report within ninety (90) days after
the effective date of termination of all costs incurred and all funds
received; in the event that this Agreement is terminated by UNIVERSITY,
expenses associated with termination shall not be included in UNIVERSITY's
calculation of costs incurred. The report will be accompanied by a check in
the amount of any excess of funds advanced over costs incurred, or by final
invoice for amounts due. UNIVERSITY will also provide IgX with a report
summarizing the Research Plan results through the date of termination.
8.3 Termination of this Agreement shall not relieve UNIVERSITY and
the PRINCIPAL INVESTIGATOR of any obligations of confidentiality provided for
in Article 5 of this Agreement.
ARTICLE 9. General Provisions
9.1 Any notices permitted or required hereunder shall be deemed
effective if made in writing and sent, postage prepaid as follows:
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
[Addresses Continued on Next Page]
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To UNIVERSITY: Xxxxx X. Xxxxxxx, Director
Sponsored Projects Services
The University of Arizona
000 Xxxxx Xxxxxx Xxxxxx, 510
P.O. Box 210158
Xxxxxx, Xxxxxxx 00000
With a copy to: Xxxx X. Xxxxx, Ph.D., Director
Office of Technology Transfer
The University of Arizona
000 Xxxxx Xxxxxx Xxxxxx, 515
P.O. Box 210158
Xxxxxx, Xxxxxxx 00000
and Xxxxxxx X. Xxxxx, DVM, Ph.D.,
Associate Professor
Department of Veterinary Science
The University of Arizona
Administration Xxxxxx 000, Xxxxxxxx 00
Xxxxxx, Xxxxxxx 00000
9.2 This Agreement embodies the entire understanding of the parties
and supersedes any other agreement of understanding between or among the
parties relating to the subject matter hereof. No waiver, amendment or
modification of this Agreement shall be valid or binding upon the parties
unless made in writing and signed on behalf of each party by their respective
property officers who are duly authorized to do so.
9.3 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 UNIVERSITY. UNIVERSITY agrees not to assign any of its rights or
obligations under this Agreement to any other party without first obtaining
IgX's written approval.
9.4 IgX agrees that this Agreement shall be binding upon and inure to
the benefit of its respective successors and assigns.
9.5 Waiver by either party of any breach or default of any clause of
this Agreement by the other party shall not operate as a waiver of any
previous or future default or breach of the same or different clause of this
Agreement.
9.6 This Agreement shall in all respects be interpreted and construed
in accordance with laws of the State of Arizona.
9.7 The headings of the several sections are inserted for convenience
of reference only and are not intended to be a part of or to affect the
meaning or interpretation of the Agreement.
9.8 If any of the provisions of this Agreement are held void or
unenforceable, the
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remaining provisions shall nevertheless be effective, the intent being to
effectuate this Agreement to the fullest extent possible.
9.9 The parties agree to be bound by applicable state and federal
rules governing equal employment opportunity and non-discrimination.
9.10 The parties recognize that the performance by the Arizona Board
of Regents for and on behalf of UNIVERSITY 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 UNIVERSITY's
appropriation is reduced during the fiscal year, the Board of Regents may
reduce the scope of this Agreement if appropriate or 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.
9.11 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.
9.12 UNIVERSITY reserves unto itself a nonexclusive free-of-charge
right to use UNIVERSITY's INVENTIONS and JOINT INVENTIONS(S) solely in
connection with its teaching and research functions.
9.13 IgX shall not incur any liability for any act or failure to act
by employees of UNIVERSITY as a result of the performance of the SPONSORED
RESEARCH and UNIVERSITY shall not accept any liability for any act or failure
to act by employees of IgX as a result of the performance of the SPONSORED
RESEARCH.
9.14 Exhibit "A" is made part hereof for all purposes.
9.15 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.
[The Remainder of This Page Intentionally Left Blank]
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IN WITNESS THEREOF, the parties have caused this Agreement to be
executed by their duly authorized representatives as of the day and year first
above written.
UNIVERSITY: Arizona Board of Regents,
on behalf of The University of Arizona
By:
-------------------------------------
Print Name:
--------------------------------
Title:
-------------------------------------
IgX: IgX Corp.,
a Delaware corporation
By:
----------------------------------------
Xxxxxx X. Xxxxx, Chairman
I have read this Agreement. I understand, accept and will abide by the terms
and conditions of this Agreement.
-----------------------------------------
Xxxxxxx X. Xxxxx, DVM, Ph.D
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EXHIBIT "A"
RESEARCH PLAN
A-1
EXHIBIT "B"
LICENSE AGREEMENT
This LICENSE AGREEMENT (the "Agreement") is made as of the 1st day of
July, 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 ("IgX"), having a principal address at 00000
Xxxxx Xxxxxx Xxxx Xxxxx, Xxxxx 000, Xxxxxxx, Xxxxxxxx 00000.
WHEREAS, LICENSOR represents that Xxxxxxx X. Xxxxx, DVM, Ph.D.,
employee of LICENSOR, is the Inventor who has submitted a disclosure,
Monoclonal Antibodies Reactive with Multiple Neutralization-Sensitive Surface
Epitopes as a Source of Treatment of Enteric Cryptosporidiosis in Humans (a
portion of which constitutes the "INVENTION" as defined in Exhibit "A" of the
accompanying Research Agreement), to LICENSOR, which disclosure (attached
hereto as Exhibit "A") was assigned log number UA1411;
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 that certain Patent
Application referenced on Exhibit "A" attached hereto and incorporated herein
by this reference (the subject matter of which is described on the Abstract
attached thereto) filed (or to be filed) by IgX in the name of Xxxxxxx X.
Xxxxx, 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.
B-1
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 INVENTION for
REGULATOR-approved human therapeutics in the treatment of cryptosporidiosis in
patients with Acquired Immune Deficiency Syndrome (AIDS) and in certain immune
competent human patients. 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.
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
B-2
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. 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) ("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 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.
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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).
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.
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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.
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)
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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 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. 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.
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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 Board of Regents may
reduce the scope of this Agreement if appropriate or 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 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
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The University of Arizona
000 Xxxxx Xxxxxx Xxxxxx, 510
P.O. Box 210158
Xxxxxx, Xxxxxxx 00000
With a copy to: Xxxx X. Xxxxx, Ph.D., Director
Office of Technology Transfer
The University of Arizona
000 Xxxxx Xxxxxx Xxxxxx, 515
P.O. Box 210158
Xxxxxx, Xxxxxxx 00000
and Xxxxxxx X. Xxxxx, DVM, Ph.D., Associate Professor
The University of Arizona
Department of Veterinary Science
Xxxxxxxxxxxxxx Xxxxxx 000, Xxxxxxxx 00
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.
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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.
[The Remainder of This Page Intentionally Left Blank]
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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 written
above.
LICENSOR: Arizona Board of Regents,
on behalf of The University of Arizona
By:
-------------------------------------
Print Name:
--------------------------------
Title:
-------------------------------------
IgX: IgX Corp.,
a Delaware corporation
By:
----------------------------------------
Xxxxxx X. Xxxxx, Chairman
The Inventor has read and understands the terms and conditions of this
Agreement and by his signature below accepts said terms and conditions.
----------------------------------------
Xxxxxxx X. Xxxxx, DVM, Ph.D
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EXHIBIT "A"
INVENTION
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EXHIBIT "B"
RESEARCH PLAN
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