RESEARCH COLLABORATION AGREEMENT ON RX-0201 CLINICAL DEVELOPMENT
Exhibit
10.5
ON
RX-0201 CLINICAL DEVELOPMENT
This
RESEARCH
COLLABORATION AGREEMENT ON RX-0201 CLINICAL DEVELOPMENT (the
"Agreement") is entered into between Rexahn Corporation, a company based
in the
United States, carrying on business at 0000 Xxxxx Xxxxxx Xxxxxxx, Xxxxxxxxx
XX
00000 XXX ("REXAHN ") and REXGENE Biotech Co., Ltd., located at 0000-00
Xxxxxx-Xxxx, Xxxxxx-Xx, Xxxxx, Xxxxx ("REXGENE"). REXAHN and REXGENE are
collectively referred to as "Parties" and individually referred to as "Party"
in
this Agreement.
WHEREAS,
REXAHN
has developed a certain proprietary therapeutic compound for the treatment
of
cancer denominated as RX-0201;
WHEREAS,
REXGENE
is engaged in the development of pharmaceutical products; and,
WHEREAS,
the
Parties are interested in pursuing collaborative research and development
efforts regarding RX-0201;
NOW
THEREFORE,
in
consideration of the mutual promises contained herein, and for other good
and
valuable consideration, the receipt of which is hereby acknowledged, REXGENE
and
REXAHN agree as follows:
1
1.
|
|
DEFINITIONS
|
1.1
|
Licensed
Technology
shall mean technology relating to REXAHN Product RX-0201, including
all
Improvements resulting from research and development efforts pursuant
to
this Agreement.
|
1.2
|
Licensed
Patents shall
mean all United States and foreign patents presently or in the
future
issued that cover Licensed Technology, including continuation,
divisional,
reexamined and reissued patents, issuing or claiming priority,
either
directly or indirectly, from pending United States Provisional
Application
No. 60/404010 filed August 16,
2002.
|
1.3
|
Licensed
Products shall
mean any and all drug products, including those incorporated in
combination products, which consist of, include or in anyway incorporate
the Licensed Technology.
|
1.4
|
Improvements
shall
mean all improvements, developments, discoveries and inventions
that
relate to the Licensed Products.
|
1.5
|
Net
Sales
shall mean all gross revenues, derived from sales, minus commissions,
sales taxes, shipping, and insurance
costs.
|
1.6
|
Territory
shall
mean all countries in Asia.
|
2.
|
COLLABORATIVE
RESEARCH & REGISTRATION
EFFORTS
|
2.1.
|
The
Parties shall cooperate fully to develop a research and development
plan
for the purpose of registering RX-0201 for sale and use in the
Republic of
Korea ("Korea") and in other countries within the Territory. The
research
and development plan shall include, at a minimum, clinical and
animal
trials to be conducted in the United States, clinical trials to
be
conducted in Korea and other Asian countries, and the exchange
of data
derived from such trials.
|
2
2.2.
|
REXAHN
shall provide, as its initial contribution to the joint development
and
research, a License to the Licensed Technology for the purpose
of
permitting research and development by
REXGENE.
|
2.3.
|
REXGENE
shall provide, as its initial contribution to the joint development
and
research, One Million Five Hundred Thousand Dollars (US $1,500,000)
to be
used by REXAHN in the further development of RX-0201.
|
2.4.
|
The
Parties will each contribute those efforts necessary to perform
the agreed
upon research and development tasks. Specifically, REXGENE will
conduct
the clinical trials necessary for registration of Licensed Products
in
Korea and other countries in the Territory. REXGENE will bear its
own
expenses and costs in connection with these activities. REXAHN
will
conduct those animal and clinical trials in the United States or
otherwise
outside the Territory on RX-0201.
|
2.5.
|
The
Parties will share data derived from any research and trials without
further fees.
|
2.6.
|
REXGENE
will be responsible for, and bear the expense for, all registration
and
other approvals in connection with the use or sale of Licensed
Products in
Korea and other countries in the
Territory.
|
3
2.7.
|
REXAHN
will prosecute all patent applications and bear all costs outside
of the
Territory. REXGENE will prosecute all patent applications and bear
all
costs within the Territory, but, REXAHN will undertake to prosecute
patent
applications for the Licensed Technology in Korea, Japan, China
and
India.
|
2.8.
|
Both
Parties agree to share any Improvements and to provide all assistance
necessary to pursue additional patent rights arising from such
Improvements.
|
2.9.
|
REXGENE
and REXAHN will have the License Rights described in Section 2
of this
Agreement.
|
3
|
GRANT
OF LICENSE
|
3.1
|
REXAHN
agrees to grant and does hereby grant to REXGENE an exclusive license
within the Territory, with right to sublicense, to employ the Licensed
Technology to make, have made, use, sell, and import Licensed Products.
|
3.2
|
REXGENE
agrees to grant and does hereby grant to REXAHN an exclusive license
everywhere outside the Territory, with right to sublicense, to
employ the
Licensed Technology to make, have made, use, sell, and import Licensed
Products.
|
4.
|
ROYALTIES
|
4.1
|
REXGENE
agrees to pay REXAHN a royalty of three percent (3%) of Net Sales
of
Licensed Products in each country in the Territory by REXGENE or
any
Sublicensee of REXGENE.
|
4
4.2
|
Royalties
shall be payable by REXGENE quarterly, due thirty (30) days following
the
last day of each calendar quarter, and shall be accompanied by
a statement
explaining the basis for the amount of each
payment.
|
5.
|
THIRD
PARTY INFRINGEMENT
|
5.1
|
Should
either Party become aware that any Licensed Patent is being or
has been
infringed by a third party within the Territory, such Party shall
promptly
notify the other Party in writing. REXGENE shall have the right
to take
appropriate action, including the right to bring a suit for infringement
of the Licensed Patent, against such third party infringer. The
cost of
any such action taken by REXGENE, including attorney's fees, shall
be
borne by REXGENE and any settlement, damages or other recovery
shall be
the sole property of REXGENE.
|
5.2
|
Should
REXGENE elect not to proceed against any third party infringer
within the
Territory within thirty (30) days after being requested in writing
to do
so by REXAHN, REXAHN may take appropriate action, including bringing
suit
for infringement. The cost of any such action taken by REXAHN,
including
attorney's fees, shall be borne by REXAHN and any settlement, damages
or
other recovery shall be the sole property of REXAHN. Should REXAHN
bring
any suit against a third party for infringement of a Licensed patent
in
the Territory, REXGENE agrees to voluntarily join in such suit
and be
represented by REXAHN's
counsel.
|
5
5.3
|
Should
REXGENE and REXAHN agree to jointly proceed against any third party
infringer, they shall equally divide the cost of any action taken
by them
and shall equally divide any settlement, damages or other recovery
realized by such action.
|
6.
|
INDEMNIFICATION
|
6.1
|
REXGENE
shall hold REXAHN free and harmless from any liability, loss, damage
or
expenses including attorney's fees, arising from a claim of personal
injury or property or commercial damages resulting from the manufacture,
use or sale of the Licensed Products by REXGENE or its Sublicensees.
|
6.2
|
REXAHN
shall hold REXGENE free and harmless from any liability, loss,
damage or
expenses including attorney's fees, arising from a claim of infringement
of any third party's patent, trademark or other industrial property
rights, which may result from the manufacture, use, distribution
or sale
of the. Licensed Products by REXGENE or its
Sublicensees.
|
7.
|
TERMINATION
|
7.1
|
Unless
earlier terminated, this Agreement shall terminate upon the last
to expire
of the Licensed Patents, or if no Licensed Patent is granted, then
within
20 years from the date of this Agreement.
|
7.2
|
In
the event either Party breaches any of its obligations to be performed
under this Agreement, the other Party shall have the right to terminate
this Agreement upon ninety (90) days written notice of termination
specifying the obligations breached; provided, that, if within
said ninety
(90) days, the breaching party remedies the breaches specified
in the
notice, this Agreement shall not be
terminated.
|
6
8.
|
NOTICE
|
8.1
|
Written
Notice.
Any notice or other communication required under this Agreement
shall be
in writing and deemed to have been duly given if: the notice is
personally
delivered to the other Party; or the notice is mailed by certified
mail or
registered mail, return receipt requested, and delivery thereof
to the
address of the other Party is evidenced by a return
receipt.
|
8.2
|
Notice
Address.
Any notice or other communication required under this Agreement
shall be
addressed and delivered by one Party to the other Party at the
following
addresses:
|
REXGENE:
|
Rexgene
Biotech Co., Ltd.
|
0000-00
Xxxxxx-Xxxx
|
Xxxxxx-Xx,
Xxxxx, Xxxxx
|
Att'n:
Suk Xxxxx Xxxx, CEO
|
REXAHN
:
|
Rexahn
Corporation
|
0000
Xxxxx Xxxxxx Xxxxxxx,
|
Xxxxxxxxx,
Xxxxxxxx 00000
|
Att'n:
Xxxxx Xxx, CEO
|
7
9.
|
MERGER
AND INTEGRATION
|
This
Agreement, together with the attachments hereto, contains the entire
understanding of the Parties relating to the subject matter hereof and shall
only be amended by a written document, duly executed on behalf of the respective
Parties. This Agreement supersedes all prior understandings, representations,
negotiations and correspondence between the Parties, including all courses
of
performance, course of dealing, and usage of trade.
10.
|
GOVERNING
LAW
|
This
Agreement and the performance of the Parties hereunder shall be governed
by,
construed, and enforced under the laws of the state of Maryland and the Federal
laws of the United States, with the exception of its conflict of law
rules.
11.
|
RELATIONSHIPS
|
Nothing
contained in this Agreement shall constitute any Party a partner, joint
venturer, agent or representative of any other Party or to create any
relationship of trust or partnership. No Party shall have the authority to
act
for, or incur obligations on behalf of, any other Party except as provided
specifically in this Agreement
12.
|
ASSIGNMENT
|
This
Agreement shall not be assignable in whole or in part by either party without
the prior written consent of the other party, provided, however, that either
party may assign this Agreement without consent to any purchaser of the business
to which this Agreement pertains.
8
13.
|
BREACH
AND DISPUTE RESOLUTION
|
13.1
|
Good
Faith Negotiation.
In
the event of a dispute, the Parties agree to use their best efforts
to
negotiate in good faith between themselves for a period of thirty
(30)
days, or such longer period as may be mutually agreed, to resolve
all such
disputes in an amicable manner.
|
13.2
|
Breach.
Each breach of this Agreement shall be measured independently.
Any failure
by either Party to act in relation to any breach shall not constitute
acquiescence or a waiver of any right of that
Party.
|
13.3
|
Legal
Claims.
Any and all claims arising in connection with this Agreement shall
be
subject to the jurisdiction of the appropriate courts of the State
of
Maryland and the U.S. District Court for the District of Maryland.
The
Parties hereby waive any and all claims to lack of jurisdiction
(including
personal jurisdiction and venue) of such courts. A Party may enforce
a
judgment thus obtained in the courts of any jurisdiction. Nothing
in this
Agreement shall prevent either Party from obtaining preliminary
injunctive
relief.
|
14.
|
SEVERABILITY
|
Any
term
or terms of this Agreement held to be void by a court of competent jurisdiction
under the terms of this Agreement, shall be severed from this Agreement and
replaced by a term or terms that results in equivalent economic and legal
outcomes as the severed provision. The remainder of the Agreement, as amended,
shall continue in full force and effect.
9
15.
|
COUNTERPARTS
|
This
Agreement shall be executed in two counterparts, each of which shall be deemed
to be an original, and each of which shall constitute one and the same
Agreement.
The
signatures below acknowledge the acceptance of the terms and conditions of
this
Agreement.
Rexgene
Biotech Co., Ltd
|
Rexahn
Corporation
|
||||||
By:
|
/s/
X.X. Xxxx
|
By:
|
/s/
X.X. Xxx
|
||||
Title:
|
Chief
Executive Officer
|
Title:
|
Chief
Executive Officer
|
||||
Date:
|
February
6, 2003
|
Date:
|
February
6, 2003
|
10