RESEARCH AGREEMENT
This RESEARCH AGREEMENT (the "Agreement") is made effective 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
("UNIVERSITY"), and IgX Corp., a Delaware corporation having a principal
address at 00000 Xxxxx Xxxxxx Xxxx Xxxxx, Xxxxx 000, Xxxxxxx, Xxxxxxxx 00000
("IgX").
WHEREAS, IgX desires UNIVERSITY to perform certain research work (and
is willing to advance funds to sponsor such research) as summarized in the
abstract appended hereto as Exhibit "A" and made part hereof, Expansion of
Defined Anti-Cryptosporidium IgA Monoclonal Antibodies and Assessment of
Efficacy During Intestinal Infection (the "Research Plan"), based in part on
the following University of Arizona invention disclosures by F. Xxxxxx
Xxxxxxxx, M.D., Ph.D. (the "Disclosures"): (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, 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 Disclosures was supported by
National Institutes of Health Grant AI 30223;
WHEREAS, UNIVERSITY, if applicable, has requested title to the
Disclosures 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 Disclosures made by Xx. Xxxxxxxx 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 in 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 (i) the examination and selection
of IgA monoclonal antibodies (expanded in ascites) against intestinal,
hepatobiliary and liver infections, (ii) the expansion of IgA antibodies in
serum-free bioreactors and (iii) the evaluation of bioreactor-derived IgA
monoclonal antibodies in Cryptosporidium infections, first during acute
infection in neonatal mice and then in chronic infection in immunodeficient
adult mice.
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 F. Xxxxxx Xxxxxxxx, M.D.,
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 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.
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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).
1.10 "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.
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 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 and 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, #000
P.O. Box 210158
Tucson, Arizona 85721-0158
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
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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.
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
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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 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
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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 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:
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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.
ARTICLE 8. Term and Termination of Agreement
8.1 The Research Plan shall be commenced by UNIVERSITY on or about
November 1, 1996 and shall continue for an initial period of eighteen (18)
months. Extensions of this initial eighteen (18) 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
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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
To UNIVERSITY: 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
The University of Arizona
000 Xxxxx Xxxxxx Xxxxxx, #000
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P.O. Box 210158
Tucson, Arizona 85721-0158
and F. Xxxxxx Xxxxxxxx, M.D., Ph.D.
Associate Professor
Department of Veterinary Science and Microbiology
The University of Arizona
Building 90, Room 202
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 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.
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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.
[Remainder of 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, acting for and on behalf of The
University of Arizona
By:
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Name:
-------------------------------------
Title:
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IgX: IgX Corp., a Delaware corporation
By:
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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.
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F. Xxxxxx Xxxxxxxx, M.D., Ph.D.
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EXHIBIT "A"
RESEARCH PLAN
EXHIBIT "B"
LICENSE AGREEMENT
