EXHIBIT 10.1
COLLABORATION AGREEMENT
This Agreement is made by and between Istituto Superiore di Sanita, Roma, Viale
Regina Elena 299, Roma 00161, ITALY ("ISS") and GenoMed, Inc., 909 S. Taylor
Ave., St. Louis, MO 63110, U.S.A. ("GenoMed"), effective as of May 1, 2004, as
follows:
1. COLLABORATION.
GenoMed and ISS wish to collaborate on developing angiotensin II type 1 receptor
blockers (ARB) as an effective treatment for Avian Influenza type A, (the
"Collaboration"), as more fully described in the collaboration plan attached to
this Agreement as Appendix A and incorporated herein (the "Collaboration Plan").
2. CONFIDENTIALITY AND NON-USE OBLIGATIONS.
CONFIDENTIAL INFORMATION. During the course of the Collaboration, GenoMed and
ISS may each disclose confidential and/or proprietary information, including but
not limited to each party's Materials, other proprietary materials and
technologies, economic information, business or research strategies, trade
secrets and material embodiments thereof (each party's "Confidential
Information"), to the other solely for the purpose of carrying out the
Collaboration.
CONFIDENTIALITY AND NON-USE. For a period of five (5) years from the expiration
or termination of this Agreement, whichever occurs first, the recipient shall
maintain the disclosing party's Confidential Information in confidence. The
recipient shall use the disclosing party's Confidential Information solely for
its performance of the Collaboration, unless otherwise mutually agreed in
writing.
EXCLUSIONS. The recipient's obligations of confidentiality and non-use shall not
apply to any information that, (i) is shown by contemporaneous documentation of
the recipient to have been in its rightful possession prior to receipt from the
disclosing party; (ii) is or becomes, through no fault of the recipient,
publicly known; (iii) is furnished to the recipient by a third party without
breach of a duty to the disclosing party; (iv) is independently developed by the
recipient without access to the disclosing party's Confidential information; or
(v) such disclosure is required by applicable law, provided that the disclosing
party has received advance notice of the proposed disclosure by the recipient.
3. DISCLOSURE AND OWNERSHIP OF INVENTIONS.
INVENTION DISCLOSURES. GenoMed and ISS acknowledge that the conduct of the
Collaboration may result in patentable inventions ("Inventions"). Promptly
following any development in the course of the Collaboration that could
reasonably be expected to give rise to an Invention, the party making such
development shall provide the other party with notice and a full written
description of such development (an "Invention Disclosure"). The party providing
an Invention Disclosure shall also provide the other party any additional
information reasonably requested by the other party with respect thereto.
4. OWNERSHIP AND ASSIGNMENT OF INVENTIONS.
GENOMED INVENTIONS. For purposes of this Agreement, the term "GenoMed Invention"
shall mean any invention or discovery arising out of the Collaboration which
relates solely to the GenoMed Confidential Information, the GenoMed Materials or
their use. GenoMed shall own all right, title and interest in and to any and all
GenoMed Inventions, without regard to inventorship, and ISS shall take all
actions requested by GenoMed, including executing documents of assignment, to
vest title to all GenoMed Inventions (including all intellectual property rights
therein) with GenoMed.
ISS INVENTIONS. For purposes of this Agreement, the term "ISS Invention" shall
mean any invention or discovery arising out of the Collaboration which relates
solely to the ISS Confidential Information, the ISS Materials or their use. ISS
shall own all right, title and interest in and to any and all ISS Inventions,
without regard to inventorship, and GenoMed shall take all actions requested by
ISS, including executing documents of assignment, to vest title to all ISS
Inventions (including all intellectual property rights therein) with ISS.
JOINT INVENTIONS. For purposes of this Agreement, the term "Joint Invention"
shall mean any invention or discovery arising out of the Collaboration which
relate to Confidential Information, and Materials of both parties or their use.
The parties shall jointly own all right, title and interest in and to any and
all Joint Inventions, without regard to inventorship, and each party shall take
all necessary actions, including executing documents of assignment, to vest
title to all Joint Inventions (including all intellectual property rights
therein) with both parties.
5. PATENT RIGHTS.
SOLELY OWNED INVENTIONS. Each party shall have the sole right to file,
prosecute, maintain, enforce and defend patent applications and patents with
respect to any Inventions owned solely by it, at its sole expense, and shall be
entitled to retain all amounts recovered from third parties in connection with
enforcing or defending any such patents.
JOINTLY OWNED INVENTIONS AND COMBINED MATERIALS. Unless otherwise agreed, the
parties shall jointly file, prosecute, maintain, enforce and defend patent
applications and patents with respect to Joint Inventions and the Combined
Materials, and shall share equally all expenses and third party recoveries in
connection therewith; provided, however, that ISS may, at its election and sole
expense and in its name and GenoMed's name jointly, file, prosecute and maintain
patent applications and patents covering any Joint Invention during the Option
Term (as defined in Article 6) for such Invention.
NO IMPLIED RIGHTS IN INTELLECTUAL PROPERTY. Except as expressly set forth in
Article 6 below, nothing herein shall be deemed to grant to either GenoMed or
ISS any rights under the other party's patents, patent applications, know-how
(whether patentable or unpatentable) or other intellectual property rights of
the other party.
6. OPTION TO OBTAIN LICENSE.
GenoMed hereby grants ISS an exclusive option to an exclusive worldwide license,
"ISS Option", to Provisional US Patent Application dated February 12, 2004.
Inventor David W.
Moskowitz MD, entitled "A cure for avian influenza in birds, pigs, and other
vertebrate hosts" and to any further patent applications claiming priority from
same. Such license shall include the right to sublicense. ISS may exercise its
option at any time during the Option Term by delivering to GenoMed written
notice of exercise. The "Option Term" shall be a period of one year from the
effective date of the Agreement. The terms of the license agreement shall
include the following provisions:
a) GENOMED grants exclusive worldwide rights to the patent to ISS in
exchange for:
i) patent prosecution expenses
ii) R&D development plan targeted to validate the efficacy in a
statistically significant field trial program
iii) technology transfer efforts to identify a commercial partner
iv) 30% of all technology transfer proceeds, after deduction of
patent expenses.
b) patent rights will revert back to GENOMED if after 5 years ISS is
unable to commercialize the technology, provided however that
i) ISS will still have exclusive rights for the Europe, ME Africa
Region (EMEA)
ii) ISS will still pay GENOMED 30% of all technology transfer
proceeds from the EMEA region.
7. DISPUTE RESOLUTION.
If the parties are unable to agree on the financial terms of any such license
after having negotiated in good faith for a period of at least six (6) months,
then either party may provide its written demand for binding arbitration in
accordance with the then prevailing Rules of Conciliation and Arbitration of the
International Chamber of Commerce ("ICC"). The arbitration shall be conducted in
Rome, Italy, in the Italian language. The arbitration panel shall consist of
three arbitrators selected in accordance with the ICC rules.
8. PUBLICATIONS.
Neither GenoMed nor ISS shall make any public presentation or publication
regarding the Collaboration or the results thereof (collectively, a
"Publication") without providing the text of the proposed Publication to the
other party at least thirty-days (30) days prior to submission thereof to a
publisher or any third party and obtaining the written consent of the other to
such Publication in the form provided to it. In the case of an oral
presentation, the term "text" will refer to an abstract setting forth all
material information to be covered by the oral presentation. Within this period,
at GenoMed's request, the Publication shall be delayed for a maximum of sixty
(60) days from initial disclosure in order to protect the potential
patentability of any Invention described therein. In no event shall either party
disclose any Confidential Information of the other party in any Publication. The
parties shall, in any Publication, consider joint authorship and acknowledge the
contributions and publications of the other as scientifically appropriate.
9. REPRESENTATIONS AND WARRANTIES.
Each party represents and warrants to the other party as follows:
a) Such party has full power and authority to execute and deliver this
Agreement and to perform its obligations hereunder. The execution,
delivery and performance by such party of this Agreement has been duly
and validly authorized, and no additional authorization or consent is
required in connection with the execution, delivery and performance by
such party of this Agreement.
b) This Agreement has been duly executed and delivered by such party and
constitutes a valid and legally binding obligation of such party,
enforceable in accordance with its terms.
c) All employees or consultants of such party who will be involved in the
Collaboration are and shall be bound by an obligation to assign all
Inventions made in the course of the Collaboration to such party, and
to cooperate with such party in connection with patenting any such
Inventions. Such party will not permit persons not bound by such
obligations to work on the Collaboration.
d) Such party shall use all Materials received from the other party in
compliance with all applicable laws and regulations, including, where
applicable, those relating to the treatment of laboratory animals and
NIH or EMEA guidelines pertaining to biological materials, and shall
not use any such Materials in humans.
10. NOTICES.
Routine notices of conditions or situations affecting the Collaboration will be
given in writing between the Principal Investigators of each party. All other
notices will be given in writing and delivered by mail or facsimile to the
parties as follows:
a) TO ISS:
DR. MARIA TOLLIS
Istituto Superiore di Sanita
Viale Regina Elena 299
00161, Roma, Italy
Fax: + 39-06-4938-7077
b) TO GENOMED:
DR. DAVID MOSKOWITZ
GenoMed, Inc.,
909 S. Taylor Ave.,
63110, St. Louis, MO, USA
Fax: +1 314-754-9772
11. NO WARRANTY.
EACH PARTY'S MATERIALS ARE PROVIDED WITHOUT WARRANTY OF ANY SORT, EXPRESS OR
IMPLIED, INCLUDING THE IMPLIED WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY.
Without limiting the generality of the foregoing, neither party makes any
representation or warranty that the use of the Materials will not infringe any
patent or other intellectual property right.
12. TERM; TERMINATION.
The term of this Agreement (the "Term") shall begin on the date hereof and end
forty-two (42) months thereafter, unless extended by mutual written consent.
Either party may terminate this Agreement in the event of a material breach of
this Agreement by the other party if said breach has not been not cured within
thirty (30) days following the breaching party's receipt of a notice describing
such breach. ISS may terminate this Agreement in the event of adverse, negative
of statistically insignificant results in the Field Studies Program. Upon
termination or expiration of this Agreement, unless otherwise mutually agreed,
both parties shall destroy all Data, except that each party may retain one (1)
copy of the Data in its legal archives for the sole purpose of monitoring its
obligations hereunder.
13. SURVIVAL.
The provisions of Articles 2, 3, 4, 5, 7 and 11 shall survive termination or
expiration of this Agreement.
14. INDEPENDENT CONTRACTORS; USE OF NAMES.
The parties shall perform this Agreement in the capacity of independent
contractors. Neither party, nor their respective employees, consultants or
representatives, shall be considered employees, partners, or agents of the other
party. No use of the name, trade name, trademark or logo of either party (the
"Named Party"), its Affiliates or any of their respective Employees, or any of
the constituent parts thereof, may be made by the other party in any form of
publicity, promotion, news release or disclosure, or is connection with the sale
of products, processes, devices, or designs, without the prior written approval
of the Named Party. At least twenty (20) business days' notice is required for
written approval. Neither party may make any representations or commitments on
the other party's behalf without the named party's prior written consent.
15. ASSIGNMENT.
This, Agreement may not be assigned or transferred without the prior written
consent of both parties, which consent shall not be unreasonably withheld;
provided, however, upon written notice to ISS, GenoMed may freely assign this
Agreement to any person or entity who acquires all or substantially all of its
business or assets (or of the business division or product line of such party to
which the Collaboration primarily relates).
16. ENTIRE AGREEMENT; AMENDMENT.
This Agreement is the entire agreement of the parties relating to the subject
matter hereof. It may not be amended or modified except in writing signed by
both GenoMed and ISS.
17. GOVERNING LAW.
This Agreement shall be governed by, and construed in accordance with the laws
of Italy, without regard to the conflicts of laws provisions thereof.
GENOMED, INC. ISTITUTO SUPERIORE DI SANITA
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Dr. David Moskowitz Da: Prof Enrico Garaci
Chief Executive Officer Presidente
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E per conoscenza
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Dr. ssa Maria Tollis
Dirigente di Ricerca
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