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EXHIBIT 10.5
MEDICAL COLLEGE OF HAMPTON ROADS
D/B/A
EASTERN VIRGINIA MEDICAL SCHOOL
RESEARCH FUNDING AGREEMENT
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RESEARCH FUNDING AGREEMENT
This Research Funding Agreement (the "Agreement") is entered into and
made as of the 31st day of January, 2000, by and between MEDICAL COLLEGE OF
HAMPTON ROADS d/b/a EASTERN VIRGINIA MEDICAL SCHOOL ("EVMS"), whose mailing
address is P.O. Box 1980, Norfolk, Virginia 23501, and GMP EndoTherapeutics,
Inc. ("GMP"), whose mailing address is One East Broward Blvd., Suite 1701, Fort
Lauderdale, Florida 33301 with respect to the facts set forth below.
RECITALS
A. EVMS is engaged in scientific biomedical and biochemical
research, including research relating to animal and human
pancreatic beta cell growth factors, islet neogenesis
associated proteins ("INGAP"), INGAP genes, reagents for
regulating INGAP expression or activity and uses thereof, as
more particularly described herein.
B. EVMS and McGill University ("McGill") are the owners of
certain patents and patent applications, including any
divisions, continuations, reissues, reexaminations,
continuations-in-part and international and foreign
applications and patents corresponding thereto and issued
thereon (hereinafter collectively referred to as the
"Patents") which are being licensed to GMP under a license
agreement of even date between EVMS, McGill and GMP (the
"License Agreement").
C. GMP desires to provide certain funding as part of the EVMS
research activities described above and which will assist the
parties in the successful approval and commercialization of
products that are covered in whole or in part by the Patents.
D. EVMS has or shall have the exclusive right to convey the
ownership rights in and to any technology developed pursuant
to the research program described herein.
E. EVMS is willing to grant to GMP the right to acquire exclusive
ownership of technology arising from the Research Program
within the Field (as those terms are defined hereinbelow),
including the right to develop, market and sell products in
the Field, all as more particularly described herein.
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AGREEMENT
NOW, THEREFORE, in consideration of the mutual covenants and conditions
outlined herein, EVMS and GMP hereby agree as follows:
1. DEFINITIONS
1.1 Agents. The term "Agents" shall mean employees,
students, consultants, and independent contractors or
other persons under the control or supervision of
EVMS or GMP, as applicable and their respective
subcontractors.
1.2 Confidential Information. The term "Confidential
Information" shall mean any and all proprietary
information owned or possessed by EVMS or GMP which
may be exchanged between the parties at any time and
from time to time during the term hereof. The fact
that a party may have marked or identified as
"Confidential" or "Proprietary" any specific
information shall be indicative that such party
believes such information to be confidential or
proprietary, but the failure to so mark information
shall not conclusively determine that such
information was or was not considered confidential
information by such party. Information shall not be
considered confidential to the extent that it:
a. Is publicly disclosed through no
fault of any party hereto, either
before or after it becomes known to
the receiving party; or
b. Was known to the receiving party
prior to the date of this
Agreement, which knowledge was
acquired independently and not from
the other party hereto (including
such party's employees); or
c. Is subsequently disclosed to the
receiving party in good faith by a
third party who has a right to make
such disclosure; or
d. Has been published by a third party
as a matter of right; or
e. Is independently developed by the
receiving party.
1.3 Field. The term "Field" shall mean animal and human
pancreatic beta cell growth factors, islet neogenesis
associated proteins ("INGAP"), including peptides,
peptidomimetics, derivatives or analogs thereof;
INGAP genes, including nucleic acid fragments and
derivatives or analogs thereof; reagents for
regulating INGAP expression or activity and
therapeutic and diagnostic uses thereof.
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1.4 Principal Investigator. The term "Principal
Investigator" shall mean the person identified in
Section 2.3 below, together with such replacement
persons selected in accordance with the provisions
thereof.
1.5 Proprietary Property. The term "Proprietary Property"
shall mean, any and all technology, discovered,
developed or otherwise arising during the term of
this Agreement, including without limitation, any
idea, data, compound, molecule, cell line, material,
know-how, technique, method, process, use,
composition, skill, Confidential Information, trade
secret or configuration of any kind, whether or not
any such information would be enforceable as a trade
secret, the copying of which would be enjoined or
restrained by a court as constituting copyright
infringement or unfair competition or would be
eligible for protection under the patent laws of the
United States or elsewhere.
1.6 Research Program. The term "Research Program" shall
mean the research program to be undertaken by EVMS
under the direction and control of the Principal
Investigator set forth in Section 2.3 hereof.
1.7 EVMS Technology. The term "EVMS Technology" shall
mean any Proprietary Property outside the Field
conceived or first reduced to practice, in whole or
in part by EVMS or EVMS Agents in the performance of
the Research Program during the term of this
Agreement, including any intellectual property within
the scope of the Research Program but outside the
Field developed by EVMS or EVMS Agents during the
term of this Agreement while rendering services to
GMP as a consultant or otherwise.
1.8 GMP Technology. The term "GMP Technology" shall mean
any Proprietary Property within the Field conceived
or first reduced to practice by EVMS or EVMS Agents
during the period such persons were working on
projects or activities funded by this Agreement, or
and Proprietary Property provided to EVMS or EVMS
Agents by GMP or its Agents.
Other capitalized terms used herein are as defined in the
License Agreement.
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*** CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS.
2. CONDUCT AND FUNDING OF RESEARCH PROGRAM
2.1 Conduct of Research Program. EVMS hereby agrees to
conduct the Research Program in the Field subject to
the provisions of this Agreement. The research and
development activities to be conducted under this
Agreement shall include the work required to obtain
Registration Approval and commercial acceptance of
Licensed Products. The initial activities should
include animal experiments required to obtain
governmental approval for commercial use of the
Licensed Products and to obtain approval by the FDA
to initiate Phase I Clinical Trials. EVMS agrees to
conduct all research and experiments and reporting of
the same in accordance with the appropriate
governmental standards. It is contemplated that the
research conducted under this Agreement shall include
Phase I Clinical Trials and other phases of Clinical
Trials, subject to the requirements of Section 2.4
below, and governmental recognition of EVMS as an FDA
approved clinical site.
2.2 Funding of Research Program. GMP shall pay to EVMS a
total of [***] to conduct the research program
contemplated by this Agreement. Such payments shall
be made in the amount of [***] per month for a
period of [***] years. The GMP funding shall not be
used to pay for indirect costs or other EVMS overhead
costs. Payments shall be made monthly, on or before
the 10th day of each month.
2.3 Supervision of Research Program. EVMS agrees that the
Research Program at EVMS shall be conducted by or
under the direct supervision of the following
Principal Investigator: Dr. Aaron Vinik. In the event
that the Principal Investigator leaves EVMS, or
terminates his/her involvement in the Research
Program, EVMS shall use its best efforts to find a
replacement Principal Investigator acceptable to GMP,
which acceptance shall not be unreasonably withheld.
In the event that EVMS shall fail to appoint a
replacement Principal Investigator reasonably
acceptable to GMP, GMP shall have a right to
terminate this Agreement upon delivery to EVMS of
written notice of intent to terminate pursuant to
this Section 2.3, which notice must be delivered to
EVMS not less than 30 days nor more than 90 days
after delivery by EVMS to GMP of the name of the
replacement Principal Investigator. Such termination
shall be considered a termination under Section 7.4.2
below.
2.4 Clinical Trials. For any research by EVMS that
includes clinical research, the parties shall enter
into additional agreements regarding coverage for
medical care costs not covered by third party payors,
indemnification for EVMS, and reimbursement for
additional clinical trial costs on a per subject
basis. These additional agreements shall be
separately negotiated prior to the commencement of
any such trials.
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2.5 Reports.
a. EVMS agrees that its efforts hereunder
include working with GMP to provide the
necessary studies, reports, protocols,
procedures, applications and other
governmental requirements in the United
States in order to achieve the approvals
necessary to allow the commercial use of
Licensed Products in animals and to initiate
Phase I Clinical trials in humans.
b. EVMS agrees to meet periodically with GMP
representatives to review the research
efforts being conducted and to be conducted
by EVMS under the Research Program and to
coordinate the efforts of both parties in
obtaining the necessary governmental
approvals for commercialization of Licensed
Products for use in animals and humans. Such
meeting shall be held at least quarterly
during the course of this Agreement.
c. EVMS agrees that within sixty (60) days
following the last day of each calendar year
during the term of this Agreement, EVMS
shall furnish GMP with a written report
summarizing the results of the research
included within the scope of the Research
Program during the immediately preceding
calendar year conducted by EVMS.
d. All information submitted by either party to
the other as a result of the Research
Program under this Agreement, whether
written, oral, electronic, or in other form,
and whether specifically marked confidential
or not, is deemed Proprietary Property. If
the Proprietary Property pertains to GMP
Technology, it shall be deemed to be
Proprietary Property belonging to GMP. If
the Proprietary Property pertains to EVMS
Technology, it shall be deemed to be
Proprietary Property belonging to EVMS. GMP
Proprietary Property will be used by EVMS
only for the purpose of conducting its
activities under this Agreement.
e. EVMS Proprietary Property shall be used by
GMP for the purposes of carrying out its
obligations or performance under this
Agreement and the License Agreement,
including evaluating whether or not to
exercise an option to obtain a license
pursuant to Section 3 hereof, as and when
such option is exercisable in accordance
with the terms hereof.
f. Neither party shall, during the term or
after the termination hereof, use or
disclose any of the Proprietary Property of
the other party to any third party, unless
and until (i) permitted to do so pursuant to
the terms of any license agreement entered
into by the parties, or (ii) such
information no longer comes within the
definition of
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"Confidential Information" hereunder and
otherwise becomes available as public
information.
3. OPTION FOR EXCLUSIVE LICENSE.
3.1 Grant of Option. Subject to the terms of this
Agreement, EVMS hereby grants to GMP an exclusive
option to acquire exclusive worldwide ownership
rights or licenses to make, have made, sell or use
EVMS Technology. Each such right or license shall be
to a specific application of EVMS Technology. Such
option shall be for the period and exercised as more
particularly described below.
3.2 Disclosure of Technology. As soon as reasonably
possible, either upon conception or reduction to
practice, as the case may be, of each and every
application of GMP Technology or EVMS Technology,
EVMS shall disclose the same in writing to GMP. Such
disclosure shall contain sufficient detail to enable
GMP to evaluate the significance of the Technology
and, if EVMS Technology, the advisability of
exercising the option granted hereunder with respect
to such EVMS Technology.
3.3 Option Period. GMP shall have a period of ninety (90)
days from receipt of the disclosure from EVMS
described in Section 3.2 within which to exercise its
option to obtain a license to a particular
application of EVMS Technology pursuant to Section
3.1.
3.4 Exercise of Option. GMP shall exercise its option to
obtain a license hereunder by delivering to EVMS a
written notice within the option period which
specifies the particular application of EVMS
Technology for which the option is being exercised.
GMP and EVMS shall have a period of sixty (60) days
from the date of exercise of option by GMP within
which to agree upon the initial royalty, royalty rate
and commercial development obligations and other
terms and conditions of the license satisfactory to
both parties.
3.5 Reservation of Rights. EVMS reserves the right to use
any EVMS Technology that may be subject to an option
pursuant to this Agreement or covered by a license
granted hereunder solely for EVMS' and/or the
contributing subcontractor's own educational and
research purposes, without EVMS being obligated to
pay GMP any royalties or other compensation related
thereto.
3.6 Right of First Refusal. In the event GMP does not
acquire rights to the EVMS Technology as provided
above, and EVMS desires to subsequently license that
EVMS Technology to a third party, EVMS shall first
offer such a license to GMP on the same terms and
conditions as that offered to the third party. If GMP
fails to exercise such offer within thirty (30) days
following receipt of such an offer, EVMS shall have
the right to license such technology to a third party
on the same terms and conditions.
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4. WARRANTIES.
4.1 Warranties. EVMS hereby warrants and represents to
GMP that: (i) no third parties have or will have any
rights to any EVMS or GMP Technologies; (ii) EVMS has
or will have the right to convey or cause to be
conveyed to GMP ownership of GMP Technology and
indicia of the same as described in Section 5.1
hereof; and (iii) it has the full right and power to
enter into this Agreement and the entering into and
performance under the Agreement shall not constitute
a breach of or default under any agreement with any
third party.
4.2 No Other Warranties. Except as provided in Section
4.1 above, EVMS MAKES NO WARRANTIES CONCERNING THE
RESEARCH PROGRAM OR ANY EVMS TECHNOLOGY OR EVMS
PATENT RIGHTS THAT MAY BE SUBJECT TO THIS AGREEMENT.
WITHOUT LIMITING THE FOREGOING, EVMS DOES NOT
REPRESENT OR WARRANT THAT IT WILL SUCCESSFULLY
COMPLETE THE RESEARCH PROGRAM OR THAT, IF COMPLETED,
THE RESEARCH PROGRAM WILL RESULT IN EVMS TECHNOLOGY
WHICH WILL BE SUBJECT TO AN OPTION HEREUNDER OR WHICH
GMP WILL DESIRE TO LICENSE. EVMS MAKES NO EXPRESS OR
IMPLIED WARRANTY, INCLUDING BUT NOT LIMITED TO ANY
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE, AS TO ANY LICENSED PRODUCT. EVMS
MAKES NO WARRANTY OR REPRESENTATION AS TO THE
VALIDITY OR SCOPE OF ANY EVMS PATENT RIGHTS OR THAT
ANY LICENSED PRODUCT WILL BE FREE FROM ANY
INFRINGEMENT OF PATENTS OF THIRD PARTIES, OR THAT NO
THIRD PARTIES ARE IN ANY WAY INFRINGING EVMS PATENT
RIGHTS.
5. INTERESTS IN INTELLECTUAL PROPERTY.
5.1 Title. EVMS shall retain such ownership and title to
EVMS Technology subject to the option of GMP set
forth herein. EVMS shall, in the good faith exercise
of its discretion, undertake reasonable efforts to
preserve and maintain its ownership and title in EVMS
Technology. GMP shall own all rights, title and
interest in GMP Technology, free and clear of all
royalties, liens, claims or other encumbrances or
obligations. EVMS agrees, and agrees to cause each
EVMS Agent to agree, in writing, to assign or
transfer all interest in GMP Technology to GMP and to
sign all patent applications and documents evidencing
ownership of such technology by GMP without
additional costs or payments.
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6. CONFIDENTIALITY AND PUBLICATION.
6.1 Confidential Information. The parties agree that
during the term of and any subsequent extension of
this Agreement and for a period of five (5) years
after it terminates or for as long as any
Confidential Information not otherwise includable
within patent rights is being utilized within a
Licensed Product, whichever is longer, a party having
Confidential Information of another party will not
use or intentionally disclose such Confidential
Information to any third party without the prior
written consent of the party which owns the
Confidential Information.
6.2 Publications. GMP acknowledges that it is the general
policy of EVMS to encourage publication of research
results in technical or scientific journals; and
subject to EVMS meeting its disclosure obligations
under Sections 3.2 and 6.1 hereof, GMP agrees that
EVMS shall have a right to publish in accordance with
its general policy. Prior to such publication, EVMS
shall submit to GMP copies of proposed publications
which contain subject matter relating to EVMS or GMP
Technology and afford GMP a period of thirty (30)
days to review the publication. Upon written request
by GMP prior to the expiration of such thirty (30)
days period and provided that GMP shall have
exercised its option to one or more applications
included within the subject matter of such
publication, EVMS shall delay any such publication
for up to sixty (60) days from the date of such
request to allow for the preparation and filing of a
patent application.
6.3 Publicity. Except as otherwise provided herein or
required by law, no party shall originate any
publication, news release or other public
announcement, written or oral, whether in the public
press, or stockholders, reports, or otherwise,
relating to this Agreement or to any license granted
hereunder, or to the performance thereunder, without
the prior written approval of the other party, which
approval shall be acted upon within five business
days and shall not be unreasonably withheld.
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7. TERM AND TERMINATION.
7.1 Term. Unless terminated sooner, the initial term of
this Agreement shall commence on the date set forth
above and shall continue for a period of five (5)
years.
7.2 Termination Upon Default. Any one or more of the
following events shall constitute an event of default
hereunder: (i) the failure of a party to pay any
amounts when due hereunder and the failure to cure
within fifteen (15) days after receipt of notice from
the other party specifying in reasonable detail the
nature of such default; (ii) the failure of a party
to perform any obligation required of it to be
performed hereunder, and the failure to cure within
sixty (60) days after receipt of notice from the
other party specifying in reasonable detail the
nature of such default; and (iii) the termination of
the License Agreement as a result of a breach or
default by the Licensor under the License Agreement.
Upon the occurrence of an event of default, the
non-defaulting party may deliver to the defaulting
party written notice of intent to terminate, such
termination to be effective upon the date set forth
in such notice. Such termination rights shall be in
addition to and not in substitution for any other
remedies that may be available to the non-defaulting
party serving such notice against the defaulting
party. Termination pursuant to this Section 7.2 shall
not relieve the defaulting party of liability and
damages to non-defaulting party for breach of this
Agreement. Waiver by any party of a single default or
a succession of defaults shall not deprive such party
of any right to terminate this Agreement arising by
reason of any subsequent default
7.3 Termination on Insolvency. This Agreement may be
terminated as to any party ("Insolvent Party") by
another party giving written notice of termination to
the Insolvent Party upon the filing of bankruptcy or
bankruptcy of the Insolvent Party or the appointment
of a receiver of any of the Insolvent Party's assets,
or the making by the Insolvent Party of any
assignment for the benefit of creditors, or the
institution of any proceedings against the Insolvent
Party under any bankruptcy law. Termination shall be
effective upon the date specified in this notice.
7.4 Effect of Expiration or Termination.
7.4.1 Termination Upon Default of GMP. Upon the
termination of this Agreement by reason of a
default by GMP, neither party shall have any
further rights or obligations with respect
to this Agreement, other than the obligation
of GMP to make any and all final payments
accrued prior to the date of termination and
the obligation of the parties to make all
reports required hereunder. Upon such
termination of this Agreement, the parties
shall continue to abide by their obligations
as described in Articles 5 and 6, and each
party hereto shall fulfill any other
obligations incurred prior to such
termination. Any such termination of this
Agreement
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shall not constitute the termination of any
license or any other agreements between the
parties which are then in effect except as
expressly provided herein.
7.4.2 Expiration or Termination Upon Default of
EVMS. Upon the expiration of this Agreement
at its regularly scheduled expiration date,
or upon a termination of this Agreement on
account of a default by EVMS, then EVMS
shall make the disclosures required by
Section 3.2 for EVMS and GMP Technology
conceived or reduced to practice up to the
date of said expiration or termination; and
GMP shall have the right to exercise its
option with respect to said EVMS Technology
in accordance with the schedule and
procedures specified in Sections 3.4 and 3.5
above. Additionally, each party shall
perform all other obligations up to the date
of said expiration or termination; and the
parties shall continue to abide by their
obligations described in Articles 5 and 6;
and any previously existing license
agreements or other agreements between the
parties shall continue in effect.
8. ASSIGNMENT: SUCCESSORS
8.1 Assignment. This Agreement may not be assigned by GMP
without the prior written consent of EVMS except to a
successor in interest to all or substantially all of
the business assets of GMP, whether by way of a
merger, consolidation, sale of all or substantially
all of GMP's assets, change of control or similar
transaction.
8.2 Binding Upon Successors and Assigns. Subject to the
limitations on assignment set forth herein, this
Agreement shall be binding upon and inure to the
benefit of any successors in interest and assigns of
EVMS and GMP. Any such successor to or assignee of a
party's interest shall expressly assume in writing
the performance of all the terms and conditions of
this Agreement to be performed by such party.
9. GENERAL PROVISIONS.
9.1 Independent Contractors. The relationship between
EVMS and GMP is that of independent contractors. EVMS
and GMP are not joint venturers, partners, principal
and agent, master and servant, employer or employee,
and have no other relationship other than independent
contracting parties. EVMS and GMP shall have no power
to bind or obligate each other in any manner, other
than as is expressly set forth in this Agreement.
9.2 Arbitration. Any controversy or claim arising out of
or relating to this Agreement, or the breach thereof,
shall be settled by alternative dispute resolution,
such as, for example, arbitration or mediation. If
the parties cannot agree on a form of alternative
dispute resolution then any dispute shall be resolved
by binding arbitration in accordance with the
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Commercial Arbitration Rules of the American
Arbitration Association ("AAA").
9.3 Entire Agreement; Modification. This Agreement and
other agreements executed by the parties or
affiliated entities dated this even date constitute
the entire agreement and understanding between the
parties as to the subject matter hereof. There shall
be no amendments or modifications to this Agreement
except by a written document, which is signed by both
parties.
9.4 Virginia Law. This Agreement shall be construed and
enforced in accordance with the laws of the State of
Virginia.
9.5 Headings. The headings for each article and section
in this Agreement have been inserted for the
convenience of references only and are not intended
to limit or expand on the meaning of the language
contained in the particular article or section.
9.6 Severability. Should any one or more of the
provisions of this Agreement be held invalid or
unenforceable by a court of competent jurisdiction,
it shall be considered severed from this Agreement
and shall not serve to invalidate the remaining
provision hereof. The parties shall make a good faith
effort to replace any invalid or unenforceable
provisions with a valid and enforceable one such that
the objectives contemplated by them when entering
this Agreement may be realized.
9.7 No Waiver. Any delay in enforcing a party's rights
under this Agreement or any waiver as to a particular
default or other matter shall not constitute a waiver
of such party's rights to the future enforcement of
its rights under this Agreement, excepting only as to
an express written and signed waiver as to a
particular matter for a particular period of time.
9.8 Attorneys' Fees. In the event of a dispute among the
parties hereto or in the event of any default
hereunder, the party prevailing in the resolution of
any such dispute or default shall be entitled to
recover its reasonable attorneys' fees and other
costs incurred in connection with resolving such
dispute or default.
9.9 Notices. Any notices required by this Agreement shall
be in writing, shall specifically refer to this
Agreement and shall be sent by registered or
certified airmail, postage prepaid, or by facsimile,
telex or cable, charges prepaid, or by overnight
courier, postage prepaid, and shall be forwarded to
the respective addresses set forth below unless
subsequently changed by written notice to the other
party:
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FOR EVMS: Medical College of Hampton Roads
d/b/a Eastern VirginiaMedical School
P.O. Box 1980
Norfolk, Virginia 23501
Attn: Vice President for Finance and Administration
Fax No.: (757) 446-6095
FOR GMP: GMP EndoTherapeutics, Inc.
One East Broward Blvd., Suite 1701
Fort Lauderdale, Florida 33301
Attn: Dr. Bart Chernow
Fax No.: (954) 745-3511
Notice shall be deemed delivered upon the earlier of (i) when
received, (ii) three (3) days after deposit into the mail,
(iii) the date notice is sent via telefax, telex or cable, or
(iv) the day immediately following delivery to overnight
courier (except Sunday and holidays).
9.10 Compliance with U.S. Laws. Nothing contained in this
Agreement shall require or permit EVMS or GMP to do
any act inconsistent with the requirements of any
United States law, regulation or executive order as
the same may be in effect from time to time.
9.11 Third Party Compliance. In the event and to the
extent EVMS engages other persons or entities not a
party to this Agreement to conduct all or any part of
the work to be performed under this Agreement, it
shall require such persons or entities to enter into
written agreements which contractually obligate such
persons or entities to the same requirements imposed
upon EVMS hereunder, including, without limitation,
the obligations under Articles 3, 4, 5 and 6 hereof.
EVMS shall provide GMP with copies of such written
agreements.
9.12 Estoppel Certificates. EVMS shall, from time to time,
upon written request of GMP, any of its Affiliates or
transferees or potential transferees, issue an
estoppel certificate to the requesting entity setting
forth the status of this Agreement, and, if in
default, stipulating the actions necessary to cure
such default.
9.13 Counterparts. This Unanimous Written Consent may be
signed in one or more counterparts, each of which
shall be deemed an original, but of which together
shall constitute one instrument.
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IN WITNESS WHEREOF, the parties have executed this Agreement by their
duly authorized representatives as of the date set forth above.
MEDICAL COLLEGE OF HAMPTON ROADS d/b/a EASTERN VIRGINIA MEDICAL SCHOOL GMP
ENDOTHERAPEUTICS, INC.
By: By:
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David Thiel, Vice President for Bart Chernow, M.D., President
Administration and Finance
By:
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Dr. Aaron Vinick
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