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Exhibit 10.32
[-#-] CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2
OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
PATENT LICENSE AGREEMENT
BETWEEN THE UNIVERSITY OF TEXAS SYSTEM,
THE UNIVERSITY OF NORTH TEXAS HEALTH SCIENCE CENTER AT FORT
WORTH
AND
MYOGEN, INC.
THIS
AGREEMENT is made by and between the BOARD OF REGENTS (BOARD) OF
THE
UNIVERSITY OF TEXAS SYSTEM (SYSTEM), an
agency of the State of Texas, whose
address is 201 West Seventh Street, Austin,
Texas 78701, THE UNIVERSITY OF
NORTH TEXAS HEALTH SCIENCE CENTER AT FORT
WORTH (UNTHSC), an agency of the
State of Texas, whose address is 3500 Camp
Bowie Boulevard, Fort Worth, Texas
76115 and MYOGEN, INC. (LICENSEE), a
Delaware corporation having a principal
place of business located at 7577 W. 103rd.
Avenue, Suite 212, Westminster, CO
80021-5426.
RECITALS
A. BOARD
and UNTHSC own certain PATENT RIGHTS and TECHNOLOGY RIGHTS
related to LICENSED SUBJECT MATTER, hereto
attached as Exhibit A, which were
developed at The University of Texas
Southwestern Medical Center at Dallas (UT
SOUTHWESTERN), located at 5323 Harry Hines
Boulevard, Dallas, Texas 75235, a
component institution of SYSTEM and at
UNTHSC at the address set forth above;
B. BOARD
and UNTHSC have entered into a JOINT OWNERSHIP AND LICENSING
COOPERATION AGREEMENT effective October 7,
1998 which has been amended (FIRST
AMENDMENT TO JOINT OWNERSHIP AND LICENSING
COOPERATION AGREEMENT) January ___,
2000, a copy of which is attached hereto as
Exhibit B;
C. BOARD
and UNTHSC desire to have the LICENSED SUBJECT MATTER developed
and used on the terms and conditions
provided for herein for the benefit of
LICENSEE, the INVENTORS, BOARD, UT
SOUTHWESTERN, UNTHSC and the public as
outlined in the Intellectual Property
Policy promulgated by the BOARD, and the
Intellectual Property Policy promulgated by
UNTHSC;
D.
LICENSEE wishes to obtain a license from BOARD and UNTHSC to
practice
LICENSED SUBJECT MATTER;
E. This
AGREEMENT between BOARD, UNTHSC and LICENSEE replaces in its
entirety that certain PATENT LICENSE
AGREEMENT BETWEEN UNIVERSITY OF TEXAS
SYSTEM, THE UNIVERSITY OF NORTH TEXAS
HEALTH SCIENCE CENTER AT FORT WORTH AND
MANTEX BIOTECH INC. dated October
7,1998.
NOW,
THEREFORE, in consideration of the mutual covenants and
premises
herein contained, the parties hereto agree
as follows:
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I. EFFECTIVE DATE
This AGREEMENT is effective Jan. 13, 2000 (EFFECTIVE DATE).
II. DEFINITIONS
As used in
this AGREEMENT, the following terms shall have the meanings
indicated:
2.1
AFFILIATE means (i) any corporation or other entity owning
directly,
or indirectly controlling, at least 50% of
the stock normally entitled to vote
for election of directors of LICENSEE, (ii)
any corporation owned or directly
controlled by LICENSEE through ownership of
at least 50% of the stock normally
entitled to vote for election of directors,
or any other entity actually
controlled by LICENSEE, or (iii) any
corporate or other entity under common
control with LICENSEE; provided, however,
that in the circumstance where the
country of incorporation of such owned or
controlled corporation requires the
maximum ownership by a foreign entity be
less than 50%, the percentage of
ownership required to make such an entity
an affiliate, will be equal to the
maximum percentage of ownership permitted
by such country.
2.2
IDENTIFIED PRODUCT means any product, or derivative thereof,
SOLD,
used, manufactured or distributed by
LICENSEE, which product or derivative is
not covered by PATENT RIGHTS but either (a)
elicits a positive response in
technologies covered by PATENT RIGHTS, or
(b) which product or derivative was
identified, selected, or found to be
useful, in whole or in part, through the
use of one or more technologies (including,
but not limited to assays, methods,
and/or reagents) covered by PATENT RIGHTS.
For greater certainty, the parties
acknowledge and agree that IDENTIFIED
PRODUCTS are not LICENSED PRODUCTS.
2.3
INVENTORS (or singly INVENTOR) means Eric Olson, Ph.D., Professor,
UT
SOUTHWESTERN, Jeffery Molkentin, Ph.D., UT
SOUTHWESTERN, and Stephen Grant,
Ph.D., Assistant Professor, UNTHSC.
2.4
LICENSED FIELD means (i) the discovery, development, manufacture,
use,
SALE, offer for SALE, and import of
pharmaceutical, biologic, gene therapy
and/or health care products for the
treatment, prevention and/or diagnosis of
cardiac hypertrophy and heart failure by
inhibition of calcineurin activity and
calmodulin-dependent protein activity, and
NFAT activity; (ii) the development,
manufacture and use of assays for the
identification of pharmaceutical and/or
biologic agents for the treatment,
prevention, and/or diagnosis of cardiac
hypertrophy and heart failure by inhibition
of calcineurin activity and
calmodulin-dependent protein activity, and
NFAT activity; and (iii) the
development, manufacture and use of assays
useful in the diagnosis of, prognosis
of, or determination of predisposition to,
cardiac hypertrophy and heart failure
by inhibition of calcineurin activity and
calmodulin-dependent protein activity,
and NFAT activity.
2.5
LICENSED PRODUCT means any compound, assay, method, reagent,
technology, or product comprising LICENSED
SUBJECT MATTER pursuant to this
AGREEMENT.
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2.6
LICENSED SUBJECT MATTER means inventions and discoveries claimed
in
PATENT RIGHTS or covered by TECHNOLOGY
RIGHTS within LICENSED FIELD.
2.7
LICENSED TERRITORY means the world.
2.8 NET
SALES means the gross revenues received by LICENSEE, AFFILIATE,
NON-SUBLICENSEE CORPORATE PARTNER, and/or
any sublicense from the SALE of
LICENSED PRODUCTS or IDENTIFIED PRODUCTS to
end users, less the following items
to the extent such items are incurred and
included in the gross price charged:
(i) trade, cash and quantity discounts or
rebates actually allowed and taken,
and other adjustments granted on account of
price adjustments, billing errors,
rejected goods, damaged goods and recall
returns; (ii) credits, rebates, fees,
reimbursements or similar payments granted
or given to wholesalers and other
distributors, groups, organizations or
institutions; (iii) tax or government
charge, duty or tariff (including any tax
such as a value added or similar tax
or government charge, other than an income
tax) levied on the sale,
transportation or delivery of a LICENSED
PRODUCT or IDENTIFIED PRODUCT; (iv)
payments or rebates paid in connection with
sales of LICENSED PRODUCTS or
IDENTIFIED PRODUCTS, to any governmental or
regulatory authority in respect of
any state or federal Medicare, Medicaid or
similar programs; (v) any charges
allowed or prepaid for freight insurance or
other transportation costs billed to
the final customer; and (vi) write-offs for
bad debt specifically on the SALE of
LICENSED PRODUCTS or IDENTIFIED PRODUCTS.
If LICENSEE SELLS a LICENSED PRODUCT
or IDENTIFIED PRODUCT to one of its
sublicensees as an end user (other than in
connection with the conduct of clinical
trials or other developmental activities
for LICENSED PRODUCTS or IDENTIFIED
PRODUCTS), such SALE shall be included
within NET SALES.
2.9
NON-SUBLICENSEE CORPORATE PARTNER means any third party with
which
LICENSEE has entered into an agreement
either to determine the feasibility of
developing and commercializing LICENSED
PRODUCTS or IDENTIFIED PRODUCTS with
such third party, or to develop and/or
commercialize LICENSED PRODUCTS or
IDENTIFIED PRODUCTS with such third party,
and where such third party is not a
sublicense under the terms of this
agreement. A NON-SUBLICENSEE CORPORATE
PARTNER shall not include any third party
for which LICENSEE is performing
assays or other screening services on a
fee-for-service basis where such
services are provided outside the context
of a possible or existing
collaborative relationship between LICENSEE
and such third party to develop and
commercialize LICENSED PRODUCTS or
IDENTIFIED PRODUCTS.
2.10
NON-SUBLICENSEE CORPORATE PARTNERSHIP REVENUES means any and
all
revenues received by LICENSEE from a
NON-SUBLICENSEE CORPORATE PARTNER in
consideration for the licenses granted to
LICENSEE hereunder; provided, however
that NON-SUBLICENSEE CORPORATE PARTNERSHIP
REVENUES shall not include: (i) any
sums received by LICENSEE from a
NON-SUBLICENSEE CORPORATE PARTNER in
consideration for the purchase of an equity
interest in LICENSEE; (ii) any sums
paid by a NON-SUBLICENSEE CORPORATE PARTNER
to support research and development
work performed by or for LICENSEE; (iii)
any sums paid by a NON-SUBLICENSEE
CORPORATE PARTNER in respect of the supply
of LICENSED PRODUCT or IDENTIFIED
PRODUCT by LICENSEE to a NON-SUBLICENSEE
CORPORATE PARTNER; (iv) any sums paid
by a NON-SUBLICENSEE CORPORATE
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PARTNER as a repayment for any loans,
credit or credit line extended by LICENSEE
to a NON-SUBLICENSEE CORPORATE PARTNER, or
any sums paid by a NON-SUBLICENSEE
CORPORATE PARTNER to LICENSEE in the form
of a loan, as credit or pursuant to a
credit line to LICENSEE; (v) royalties paid
to LICENSEE by a NON-SUBLICENSEE
CORPORATE PARTNER; and (vi) any sums paid
by a NON-SUBLICENSEE CORPORATE PARTNER
to LICENSEE in the form of a milestone
payment during the development of
LICENSED PRODUCTS.
2.11
PATENT RIGHTS means any and all rights owned, held or otherwise
controlled by BOARD and UNTHSC in
information or discoveries covered by a VALID
CLAIM as defined in Section 2.15 in patents
and/or patent applications, whether
domestic or foreign, and all divisions,
continuations, continuations-in-part,
reissues, reexaminations or extensions
thereof, and any letters patent that
issue thereon set forth in Exhibit A.
2.12 SELL,
SALE or SOLD means the transfer or disposition for value of a
LICENSED PRODUCT or IDENTIFIED PRODUCT to a
party other than LICENSEE or
AFFILIATE.
2.13
SUBLICENSE REVENUES means any and all revenues received by
LICENSEE
in consideration for the grant of a
sublicense under the licenses granted to
LICENSEE hereunder; provided, however that
SUBLICENSE REVENUES shall not
include; (i) any sums received by LICENSEE
from sublicensee in consideration for
the purchase of an equity interest in
LICENSEE; (ii) any sums paid by a
sublicensee to support research and
development work performed by or for
LICENSEE; (iii) any sums paid by a
sublicensee in respect of the supply of
LICENSED PRODUCT or IDENTIFIED PRODUCT by
LICENSEE to a sublicensee; (iv) any
sums paid by a sublicensee as a repayment
for any loans, credit or credit line
extended by LICENSEE to a sublicensee, or
any sums paid by a sublicensee to
LICENSEE in the form of a loan, as credit
or pursuant to a credit line to
LICENSEE; (v) royalties paid by a
sublicensee; and (vi) any sums paid by a
sublicensee to LICENSEE in the form of a
milestone payment during the
development LICENSED PRODUCTS.
2.14
TECHNOLOGY RIGHTS means BOARDS and UNTHSC'S rights in technical
information, know-how, processes,
procedures, compositions, devices, methods,
formulas, protocols, techniques, software,
designs, drawings or data created by
INVENTORS relating to LICENSED SUBJECT
MATTER which are not covered by PATENT
RIGHTS but which are necessary or useful
for practicing any invention covered by
PATENT RIGHTS and are not obligated to any
other third party.
2.15 VALID
CLAIM means a claim or claims of (i) an issued, unexpired
patent, whether domestic or foreign, so
long as any such claim shall not have
been held invalid or unenforceable in an
unappealed or an unappealable decision,
in a court of competent jurisdiction, or
(ii) a pending patent application,
whether domestic or foreign, so long as any
such claim shall not have been
pending for more than 5 years.
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III. WARRANTY; SUPERIOR-RIGHTS
3.1 Except
for the rights, if any, of the Government of the United States,
as set forth below, BOARD and UNTHSC
represent and warrant to the best of their
knowledge that it is the owner of the
entire right, title, and interest in and
to LICENSED SUBJECT MATTER, and that they
have the sole right to grant licenses
thereunder, and have not knowingly granted
licenses thereunder to any other
entity that would restrict rights granted
to LICENSEE except as related to known
rights owned by Tularik Corporation for
NFAT-based technology, or as otherwise
stated herein. BOARD and UNTHSC further
represent and warrant that no claim,
action, suit, proceeding, inquiry, hearing,
arbitration, administrative
proceeding or investigation (collectively,
LITIGATION) is pending or (with the
exception of claims made by Children's
Hospital Research Foundation in
Cincinnati, Ohio) threatened against BOARD
or UNTHSC affecting, involving or
relating to the LICENSED SUBJECT
MATTER.
3.2
LICENSEE understands that the LICENSED SUBJECT MATTER may have
been
developed under a funding agreement with
the Government of the United States of
America and, if so, that the Government may
have certain rights relative
thereto. This AGREEMENT is explicitly made
subject to the Government's rights
under any agreement and any applicable law
or regulation. If there is a conflict
between any agreement, applicable law or
regulation and this AGREEMENT, the
terms of the Government agreement,
applicable law or regulation shall prevail.
3.3
LICENSEE understands and acknowledges that BOARD and UNTHSC, by
this
AGREEMENT, makes no representation as to
the operability or fitness for any use,
safety, efficacy, ability to obtain
regulatory approval, patentability, and/or
breadth of the LICENSED SUBJECT MATTER.
BOARD and UNTHSC, by this AGREEMENT,
also makes no representation as to whether
there are any patents now held, or
which will be held, by others or by BOARD
and UNTHSC in the LICENSED FIELD, nor
does BOARD and UNTHSC make any
representation that the inventions contained in
PATENT RIGHTS do not infringe any other
patents now held or that will be held by
others or by BOARD and UNTHSC.
3.4
LICENSEE, by execution hereof, acknowledges, covenants and agrees
that
it has not been induced in any way by BOARD
and UNTHSC, SYSTEM, UT SOUTHWESTERN
or its employees to enter into this
AGREEMENT, and further warrants and
represents that (i) it has had sufficient
opportunity to perform due diligence
with respect to all items and issues
pertaining to this Article III and all
other matters pertaining to this AGREEMENT;
and (ii) LICENSEE believes it has
adequate knowledge and expertise, or has
utilized knowledgeable and expert
consultants, to adequately conduct the due
diligence.
IV. LICENSE
4.1 BOARD
and UNTHSC hereby grant to LICENSEE a royalty-bearing,
exclusive
license under LICENSED SUBJECT MATTER to
discover, research, develop, make, have
made, use, offer for SALE, SELL and import
LICENSED PRODUCTS and IDENTIFIED
PRODUCTS within LICENSED TERRITORY for use
within LICENSED FIELD. This grant
shall be subject to the payment by LICENSEE
to BOARD and UNTHSC of all
consideration as
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provided in this AGREEMENT, and shall be
further subject to rights retained by
BOARD and UNTHSC to:
(a) Publish the general scientific findings from research related
to
LICENSED
SUBJECT MATTER and LICENSED PRODUCTS subject to the
confidentiality terms of Article XIV, and
(b) Use LICENSED SUBJECT MATTER or IDENTIFIED PRODUCTS solely
for
research,
teaching and other educationally-related, non-commercial
purposes only. Any transfer
of LICENSED SUBJECT MATTER pursuant to this
Section
4.1(b) shall be governed by a material transfer agreement
substantially in the form attached hereto as Exhibit C.
4.2
LICENSEE cannot perform any assays using LICENSED SUBJECT MATTER
for
the development or identification of
IDENTIFIED PRODUCTS in any way for the
benefit of third parties other than
sublicensees and NON-SUBLICENSEE CORPORATE
PARTNERS. Additionally, LICENSEE can not
transfer any information regarding the
results of assays on compounds not owned by
LICENSEE to third parties other than
sublicensees or NON-SUBLICENSEE CORPORATE
PARTNERS.
4.3
LICENSEE may grant sublicenses consistent with this AGREEMENT to
its
AFFILIATES and to third parties if LICENSEE
is responsible for the activities of
its sublicensees relevant to LICENSED
PRODUCTS or IDENTIFIED PRODUCTS as if the
activities were carried out by LICENSEE,
including the payment of royalties due
to BOARD and UNTHSC hereunder whether or
not such amounts are paid to LICENSEE
by a sublicensee. LICENSEE must deliver to
BOARD and UNTHSC a true and correct
copy of each sublicense granted by
LICENSEE, and any modification or termination
thereof, within 30 days after execution,
modification, or termination. When this
AGREEMENT is terminated, all existing
sublicenses granted by LICENSEE must
either terminate or be assigned to BOARD
and UNTHSC.
4.4
LICENSEE may enter into written agreements with NON-SUBLICENSEE
CORPORATE PARTNERS consistent with this
AGREEMENT if LICENSEE is responsible for
the activities of such NON-SUBLICENSEE
CORPORATE PARTNERS relevant to LICENSED
PRODUCTS or IDENTIFIED PRODUCTS as if the
activities were carried out by
LICENSEE, including the payment of
milestone payments and royalties due to BOARD
and UNTHSC hereunder whether or not such
amounts are paid to LICENSEE. LICENSEE
agrees to provide to such NON-SUBLICENSEE
CORPORATE PARTNERS a copy of this
AGREEMENT
