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 000 Xxxx Xxxxxxx Xxxxxx, Xxxxxx, Xxxxx 00000, THE UNIVERSITY OF
NORTH TEXAS HEALTH SCIENCE CENTER AT FORT WORTH (UNTHSC), an agency of the
State of Texas, whose address is 0000 Xxxx Xxxxx Xxxxxxxxx, Xxxx Xxxxx, Xxxxx
00000 and MYOGEN, INC. (LICENSEE), a Delaware corporation having a principal
place of business located at 0000 X. 000xx. Xxxxxx, Xxxxx 000, Xxxxxxxxxxx, XX
00000-0000.
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 0000 Xxxxx Xxxxx Xxxxxxxxx, Xxxxxx, Xxxxx 00000, 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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[-#-]CONFIDENTIAL TREATMENT REQUESTED
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 Xxxx Xxxxx, Ph.D., Professor, UT
SOUTHWESTERN, Xxxxxxx Xxxxxxxxx, Ph.D., UT SOUTHWESTERN, and Xxxxxxx Xxxxx,
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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[-#-]CONFIDENTIAL TREATMENT REQUESTED
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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[-#-]CONFIDENTIAL TREATMENT REQUESTED
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 pursuant to a confidentiality agreement restricting use and disclosure
of the terms hereof. Any agreements between LICENSEE and a NON-SUBLICENSEE
CORPORATE PARTNER shall include (i) the acknowledgement by the NON-SUBLICENSEE
CORPORATE PARTNER of the payment obligations to BOARD and UNTHSC as set forth in
Article V of this AGREEMENT, (ii) product definitions and payment obligations
provided in this AGREEMENT to the extent appropriate in view of the context
within which the LICENSED SUBJECT MATTER shall be used in connection with the
development of products pursuant to such agreement with such NON-SUBLICENSEE
CORPORATE PARTNER, and (iii) a representation by the NON-SUBLICENSEE CORPORATE
PARTNER that it has received a copy of this
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AGREEMENT and understands that the payment obligations provided in Article V
hereof apply to any LICENSED PRODUCTS and IDENTIFIED PRODUCTS that may be
developed or commercialized pursuant to such agreement. LICENSEE must deliver to
BOARD and UNTHSC a true and correct copy of each NON-SUBLICENSEE CORPORATE
PARTNERSHIP agreement granted by LICENSEE, and any modification or termination
thereof, within 30 days after execution, modification, or termination thereof
(which copy may only be redacted to delete information not relevant to
determining whether LICENSEE and/or a NON-SUBLICENSEE CORPORATE PARTNER have
complied with their obligations to BOARD and UNTHSC hereunder). When this
AGREEMENT is terminated, LICENSEE'S rights to practice the LICENSED SUBJECT
MATTER in the context of a collaboration with a NON-SUBLICENSEE CORPORATE
PARTNER shall terminate. In the event of any such termination of LICENSEE'S
rights to practice the LICENSED SUBJECT MATTER, the payment obligations of this
AGREEMENT with respect to any IDENTIFIED PRODUCTS that are sold by either
LICENSEE or its NON-SUBLICENSEE CORPORATE PARTNER shall survive.
V. PAYMENTS AND REPORTS
5.1 In consideration of rights granted by BOARD and UNTHSC to LICENSEE
under this AGREEMENT, LICENSEE agrees to pay the following:
(a) An annual license fee of [-#-] due and payable within 30 days of
August 1, 2003 and on each anniversary of the EFFECTIVE DATE thereafter;
(b) Milestone payments according to the schedule shown below are due
within 30 days of the initiation of each milestone event in the
development of any LICENSED PRODUCT or IDENTIFIED PRODUCT, [-#-] Once a
milestone payment has been made for a particular milestone event shown
below, no further payments shall be due upon any subsequent occurrence of
such milestone event. The amounts of the milestone payments are as
follows:
Initiation of Phase One clinical trials [-#-]
Initiation of Phase Two clinical trials [-#-]
Initiation of Phase Three clinical trials [-#-]
Filing of an NDA for a LICENSED PRODUCT
or IDENTIFIED PRODUCT [-#-]
For the purpose of this Section 5.1(b), "Initiation" shall mean receipt by
the first patient of the first dose of a LICENSED PRODUCT or IDENTIFIED
PRODUCT.
(c) A running earned royalty equal to [-#-] of NET SALES of any and
all LICENSED PRODUCTS covered by PATENT RIGHTS, and/or IDENTIFIED
PRODUCTS;
(d) [-#-] of any and all revenues from either SUBLICENSE REVENUES or
NON-SUBLICENSEE CORPORATE PARTNERSHIP REVENUES, whichever applies;
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(e) [-#-]
5.2 Commencing upon the first to occur of (a) LICENSEE'S receipt of
SUBLICENSE REVENUES, (b) LICENSEE'S receipt of NON-SUBLICENSEE CORPORATE
PARTNERSHIP REVENUES, or (c) first SALE of a LICENSED PRODUCT or IDENTIFIED
PRODUCT and continuing for the remainder of the term of this AGREEMENT and for 1
year thereafter, LICENSEE shall keep complete and accurate records of its
NON-SUBLICENSEE CORPORATE PARTNERS', and its sublicensees' SALES and NET SALES
of LICENSED PRODUCTS and IDENTIFIED PRODUCTS under the license hereunder and of
SUBLICENSE REVENUES and NON-SUBLICENSEE CORPORATE PARTNERSHIP REVENUES in
sufficient detail to enable the royalties payable hereunder to be determined.
LICENSEE shall permit an independent certified public accountant selected by
BOARD and UNTHSC and reasonably acceptable to LICENSEE, to examine such records
solely for the purpose of and solely to the extent necessary to verify any
report required under this AGREEMENT, provided that no more than one examination
may be conducted during any calendar year, any such examination may occur only
during LICENSEE'S regular business hours, and any such examination will occur
only after at least 10 business days prior written notice. [-#-]
5.3 Within 30 days after March 31, June 30, September 30, and December 31
of each year, following the first to occur of (a) LICENSEE'S receipt of
SUBLICENSE REVENUES, (b) LICENSEE'S receipt of NON-SUBLICENSEE CORPORATE
PARTNERSHIP REVENUES, or (c) first SALE of a LICENSED PRODUCT or IDENTIFIED
PRODUCT, LICENSEE shall deliver to BOARD and UNTHSC a true and accurate report
of SUBLICENSE REVENUES and NON-SUBLICENSEE CORPORATE PARTNERSHIP REVENUES
received and of the NET SALES of LICENSED PRODUCTS or IDENTIFIED PRODUCTS, (if
any) during the preceding 3 calendar months under this AGREEMENT. Such report
will include at least (i) the quantities of LICENSED PRODUCTS, and IDENTIFIED
PRODUCTS that it, its NON-SUBLICENSEE CORPORATE SPONSORS, and its sublicenses
have produced; (ii) the total of all SALES of LICENSED PRODUCTS or IDENTIFIED
PRODUCTS; (iii) the calculation of royalties thereon; (iv) the total royalties
so computed and due BOARD and UNTHSC, and (v) the amount of SUBLICENSE REVENUES
and NON-SUBLICENSEE CORPORATE PARTNERSHIP REVENUES received and the amounts of
such revenues due BOARD and UNTHSC. Simultaneously with the delivery of each
such report, LICENSEE shall pay to BOARD and UNTHSC the amount, if any, due for
the period covered by such report. If no payments are due, it shall be so
reported.
5.4 Once per calendar year on the anniversary of the EFFECTIVE DATE of
this AGREEMENT, LICENSEE shall deliver to BOARD and UNTHSC a written report as
to LICENSEE'S efforts and accomplishments during the preceding year in
commercializing LICENSED SUBJECT MATTER and/or IDENTIFIED PRODUCTS in various
parts of the LICENSED TERRITORY and its commercialization plans for the upcoming
year.
5.5 [-#-] Checks shall be made payable to UT SOUTHWESTERN and delivered
via prepaid, first class, certified mail to:
The University of Texas Southwestern Medical Center at Dallas
Office for Technology Development
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0000 Xxxxx Xxxxx Xxxxxxxxx
Xxxxxx, Xxxxx 00000-0000
Attention: Director for Technology Development
5.6 Each party shall designate a contact person who shall endeavor to keep
his or her counterpart contact person fully informed of all information of
interest to the other or necessary to the other to carry out the obligations of
this AGREEMENT. It is the intent of the parties that the contact persons keep in
close communication to facilitate performance of this AGREEMENT.
(a) The contact persons shall utilize whatever forms of
communication are most appropriate and convenient, including without
limitation, telephone, facsimile, regular mail and overnight courier.
(b) The obligations of the contact persons hereunder are in addition
to, and not in lieu of, the requirements otherwise set forth herein for
notice, and shall not substitute for such notice.
(c) The initial contact person for LICENSEE shall be J. Xxxxxxx
Xxxxxxx, CEO and President, Myogen Inc., 0000 X. 000xx. Xxxxxx, Xxxxx 000,
Xxxxxxxxxxx, XX 00000-0000, (000) 000-0000. The contact person for BOARD
shall be Xxx Xxxxxxxx, Director, Office for Technology Development, 0000
Xxxxx Xxxxx Xxxxxxxxx, Xxxxxx, Xxxxx 00000-0000, (000) 000-0000. The
initial contact person for UNTHSC will be Xxxxxxxx Xxxxx, Vice President
for Health Affairs & Executive Xxxx, 0000 Xxxx Xxxxx Xxxxxxxxx, Xxxx
Xxxxx, Xxxxx 00000.
5.7 LICENSEE shall be responsible for payment of all patent expenses
incurred for PATENT RIGHTS exclusively licensed hereunder in accordance with the
guidelines of Article XV.
VI. STOCK; EQUITY OWNERSHIP
In consideration of the rights granted to LICENSEE by BOARD in this
AGREEMENT, LICENSEE agrees to issue to Mantex Biotech, Inc. a total of 200,901
fully paid, non-assessable shares of its Series B preferred stock as set forth
in the Stock Purchase Agreement attached hereto as Exhibit D (the "Stock
Purchase Agreement"), to be distributed by LICENSEE directly as follows: BOARD
28,929 shares; UNTHSC 19,287 shares, and ManTex Biotech 152,685 shares. BOARD,
UT SOUTHWESTERN, and UNTHSC will notify LICENSEE within 30 days after receipt of
BOARD'S and UNTHSC'S approval of this AGREEMENT and will issue written
instructions to LICENSEE detailing the procedure and guidelines for distributing
stock to BOARD and INVENTORS, as set forth in the Board of Regent's Rules and
Regulations regarding intellectual property and the intellectual property policy
of UNTHSC. These shares of preferred stock will be distributed by LICENSEE
within 30 days after receiving such instructions.
VII. SPONSORED RESEARCH
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A sponsored research agreement is not included in this agreement. LICENSEE
may choose to establish separate independent sponsored research agreements with
any or all of the INVENTORS.
VIII. TERM AND TERMINATION
8.1 This AGREEMENT shall commence upon the EFFECTIVE DATE and continue in
effect, on a country by country and product by product basis for:
(a) LICENSED PRODUCTS until the later of (i) the expiration of the
last to expire of the PATENT RIGHTS covering such product in such country,
or (ii) 15 years from the date of the first commercial SALE of such
LICENSED PRODUCT in such country, and for
(b) IDENTIFIED PRODUCTS until 15 years from the date of the first
commercial SALE of such IDENTIFIED PRODUCT in such country. The parties
expressly agree that the term of payment for LICENSED PRODUCTS or
IDENTIFIED PRODUCTS is not an extension of PATENT RIGHTS beyond their
term, but rather the parties' desire to compensate BOARD and UNTHSC from
revenues LICENSEE may have in the future derived indirectly from PATENT
RIGHTS licensed hereunder and for convenience of accounting.
8.2 This AGREEMENT will earlier terminate:
(a) automatically if any payment or report obligation of LICENSEE
under Article V of this AGREEMENT is received by UT SOUTHWESTERN more than
60 days after LICENSEE receives written notice that such payment(s) are in
arrears, unless, before the end of the 60 day period, LICENSEE has cured
the breach or default and so notifies BOARD and UNTHSC, stating the manner
of the cure; or
(b) under the provisions of sections 8.3 and 8.4, if invoked by
written notice specifically to stipulated PATENT RIGHTS and/or TECHNOLOGY
RIGHTS; or
(c) automatically if LICENSEE becomes bankrupt or insolvent and/or
if the business of LICENSEE is placed in the hands of a receiver,
assignee, or trustee, whether by voluntary act of LICENSEE or otherwise;
or
(d) upon 90 days written notice if LICENSEE materially breaches or
defaults on any other obligation under this AGREEMENT, unless, before the
end of the 90 day period, LICENSEE has cured the breach or default and so
notifies BOARD and UNTHSC, stating the manner of the cure; or
(e) at any time upon the mutual written agreement of LICENSEE, UT
SOUTHWESTERN, BOARD and UNTHSC, and subject to any terms herein which
survive termination.
8.3 Any time after the later of either 4 years from the EFFECTIVE DATE,
BOARD, UT SOUTHWESTERN, and UNTHSC have the right to terminate the exclusivity
of this license
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in the LICENSED TERRITORY if LICENSEE, within 60 days after receiving written
notice from UT SOUTHWESTERN or UNTHSC of intended termination of exclusivity,
fails to provide written evidence that LICENSEE, or at least one of its
AFFILIATES, NON-SUBLICENSEE CORPORATE PARTNERS, or sublicensees has
commercialized or is actively attempting to commercialize a LICENSED PRODUCT or
IDENTIFIED PRODUCT.
8.4 Any time after the later of either 5 years from the EFFECTIVE DATE,
BOARD, UT SOUTHWESTERN, and UNTHSC have the right to terminate this license in
the LICENSED TERRITORY if LICENSEE, within 60 days after receiving written
notice from UT SOUTHWESTERN or UNTHSC of intended termination, fails to provide
written evidence that LICENSEE or at least one of its AFFILIATES,
NON-SUBLICENSEE CORPORATE PARTNERS, or sublicensees has commercialized or is
actively attempting to commercialize a LICENSED PRODUCT or IDENTIFIED PRODUCT.
8.5 Written evidence provided by LICENSEE that [-#-] shall be deemed
satisfactory evidence for purposes of this Article VIII.
8.6 If this AGREEMENT is terminated for any cause:
(a) nothing herein will be construed to release either party of any
obligation matured prior to the effective date of the termination; and
(b) after the effective date of the termination, LICENSEE, its
AFFILIATES, NON-SUBLICENSEE CORPORATE PARTNERS, and/or any sublicensee may
SELL all LICENSED PRODUCTS and/or IDENTIFIED PRODUCTS on hand at the date
of termination, [-#-] and
(c) LICENSEE will be bound by the provisions of Articles XII, XIII,
and XIV of this AGREEMENT.
IX. INFRINGEMENT BY THIRD PARTIES
9.1 LICENSEE, BOARD and UNTHSC shall each provide the others prompt
written notification of alleged infringement by any third party of the PATENT
RIGHTS.
9.2 LICENSEE, [-#-] must enforce any patent exclusively licensed hereunder
against infringement by third parties and it is entitled to retain recovery from
such enforcement. [-#-] If LICENSEE does not file suit against a substantial
infringer of a patent within [-#-] of written notice thereof, then BOARD and
UNTHSC may enforce any patent licensed hereunder on behalf of itself and
LICENSEE, [-#-]
9.3 In any infringement suit or dispute, the parties agree to cooperate
fully with each other. At the request and expense of the party bringing suit,
the other party will permit access to all relevant personnel, records, papers,
information, samples, specimens, etc., during regular business hours.
X. ASSIGNMENT
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Except in connection with the sale of substantially all of LICENSEE'S
assets to a third party as it relates to this AGREEMENT, this AGREEMENT may not
be assigned by LICENSEE without the prior written consent of BOARD and UNTHSC,
which will not be unreasonably withheld. A written decision regarding LICENSEE'S
request for BOARD'S and UNTHSC'S consent to such assignment will be provided to
LICENSEE within 5 days of receipt by BOARD and UNTHSC of written notice from
LICENSEE of the proposed assignment.
XI. PATENT MARKING
LICENSEE agrees to xxxx permanently and legibly all products and
documentation manufactured or sold by it under this AGREEMENT with such patent
notice as may be permitted or required under Xxxxx 00, Xxxxxx Xxxxxx Code.
XII. INDEMNIFICATION
LICENSEE agrees to hold harmless and indemnify BOARD, INVENTOR, SYSTEM, UT
SOUTHWESTERN, and UNTHSC, their Regents, officers, employees and agents from and
against any claims, demands, or causes of action whatsoever, including without
limitation those arising on account of any injury or death of persons or damage
to property caused by, or arising out of, or resulting from, the exercise or
practice of the license granted hereunder by LICENSEE, its AFFILIATES or their
officers, employees, agents or representatives.
XIII. USE OF NAME
LICENSEE shall not use the name of UT SOUTHWESTERN, SYSTEM, BOARD, UNTHSC
or their Regents, employees or agents without express prior written consent
except as required by governmental law, rule or regulation.
XIV. CONFIDENTIAL INFORMATION
14.1 BOARD, UNTHSC and LICENSEE each agree, for the term of this AGREEMENT
and 3 years thereafter, that the terms and conditions contained in this
AGREEMENT and all other information contained in documents marked "confidential"
and forwarded to one by the other (i) are to be received in strict confidence,
(ii) are to be used only for the purposes of this AGREEMENT, and (iii) are not
to be disclosed by the recipient party, its agents or employees without the
prior written consent of the other party, except to the extent that the
recipient party can establish competent written proof that such information
("Confidential Information"):
(a) was in the public domain at the time of disclosure;
(b) later became part of the public domain through no act or
omission of the recipient party, its employees, agents, successors or
assigns;
(c) was lawfully disclosed to the recipient party by a third party
having the right to disclose it;
(d) was already known by the recipient party at the time of
disclosure;
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[-#-]CONFIDENTIAL TREATMENT REQUESTED
(e) was independently developed by the recipient; or
(f) is required by law or regulation to be disclosed.
14.2 Each party may disclose the other's Confidential Information to the
extent such disclosure is reasonably necessary in filing or prosecuting patent
applications, prosecuting or defending litigation, complying with applicable
governmental regulations or conducting pre-clinical or clinical trials, provided
that if a party is required by law or regulation to make any such disclosure of
the other party's Confidential Information it will, except where impracticable
for necessary disclosures, for example in the event of medical emergency, give
reasonable advance written notice to the other party of such disclosure
requirement and, except to the extent inappropriate in the case of patent
applications, will use reasonably diligent efforts to secure confidential
treatment of such Confidential Information required to be disclosed.
Additionally, LICENSEE may disclose the terms and conditions of this AGREEMENT
to its potential or current investors or NON-SUBLICENSEE CORPORATE PARTNERS, or
to any other entity that may potentially acquire rights or licenses from
LICENSEE provided such party agrees to the confidentiality provisions in this
Article XIV.
14.3 Each party's obligation of confidence hereunder shall be fulfilled by
using at least the same degree of care with the other party's confidential
information as it uses to protect its own confidential information. This
obligation shall exist while this AGREEMENT is in force and for a period of 3
years thereafter.
XV. PATENTS AND INVENTIONS
15.1 BOARD and UNTHSC retain the right to select the patent attorney,
patent agent and/or law firm responsible for the filing, prosecution and
maintenance of any patents related to this AGREEMENT invented whole or in part
by INVENTORS at UT SOUTHWESTERN or UNTHSC, such attorney and/or law firm to be
reasonably acceptable to LICENSEE.
15.2 [-#-]
15.3 After the EFFECTIVE DATE, LICENSEE shall bear all costs for patenting
expenses as follows:
(a) LICENSEE will [-#-] performing the services of filing,
prosecuting, enforcing and maintaining PATENT RIGHTS licensed exclusively
hereunder in the United States or any foreign countries. UT SOUTHWESTERN
will be provided with copies of all patent-related communications,
including, but not limited to, office actions, responses, and invoices,
[-#-]; or
(b) Upon LICENSEE'S written request, UT SOUTHWESTERN will prepare
and file foreign and domestic patent applications covering LICENSED
SUBJECT MATTER in the United States and foreign countries, and LICENSEE
shall bear the actual cost incurred in connection with searching,
preparing, filing, prosecuting and maintaining same. When patenting
expenses are incurred in this manner LICENSEE shall reimburse UT
SOUTHWESTERN for all reasonable out-of-pocket expenses for
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filing, prosecuting, enforcing and maintaining PATENT RIGHTS licensed
exclusively under this AGREEMENT, payment to be made within 30 days after
receipt of written notice from UT SOUTHWESTERN. UT SOUTHWESTERN shall
provide LICENSEE and UNTHSC with a copy of any and all patent applications
pertaining to LICENSED SUBJECT MATTER filed for which LICENSEE is bearing
the actual cost of filing, as well as, copies of any documents received or
filed during prosecution thereof.
15.4 LICENSEE must notify UT SOUTHWESTERN and UNTHSC of LICENSEE'S
decision to file foreign patent applications at least 45 days prior to the
foreign patent filing deadline. The notice concerning foreign filing shall be in
writing and must identify the countries where patent applications are to be
filed. If LICENSEE notifies UT SOUTHWESTERN and UNTHSC that it does not intend
to pay costs associated with any patent application in the United States or any
foreign country which UT SOUTHWESTERN and UNTHSC believe should be prepared and
filed, then UT SOUTHWESTERN and UNTHSC may file such application at their own
expense and LICENSEE shall have no rights under this AGREEMENT to said patent
application or any patent which may issue therefrom.
15.5 In order to obtain the most complete coverage possible for LICENSEE'S
activities under this AGREEMENT, the parties each shall have the right to review
and comment upon the wording of the specifications, claims and responses to
Office Actions prior to their submission to the U.S. Patent and Trademark Office
for any and all patent applications [-#-]
XVI. GENERAL
16.1 This AGREEMENT constitutes the entire and only agreement between the
parties with regard to LICENSED SUBJECT MATTER and all other prior negotiations,
representations, agreements, and understandings are superseded hereby. No
agreements altering or supplementing the terms hereof may be made except by
means of a written document signed by the duly authorized representatives of the
parties.
16.2 Any notice required by this AGREEMENT shall be given by facsimile
transmission confirmed by personal delivery (including delivery by reputable
messenger services such as Federal Express) or by prepaid, first class,
certified mail, return receipt requested, addressed in the case of BOARD to:
BOARD OF REGENTS
The University of Texas System
000 Xxxx Xxxxxxx Xxxxxx
Xxxxxx, Xxxxx 00000
ATTENTION: Office of General Counsel
Phone: (000) 000-0000
Fax: (000 ) 000-0000
with copies to: UT SOUTHWESTERN
Xxxxx X. Xxxxxxxxxx, Ph.D.
Executive Vice President for Business Affairs
0000 Xxxxx Xxxxx Xxxxxxxxx
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Xxxxxx, Xxxxx 00000-0000
Phone: (000) 000-0000
Fax: (000) 000-0000
and UT SOUTH WESTERN
Xxx Xxxxxxxx
Director for Office of Technology Development
0000 Xxxxx Xxxxx Xxxxxxxxx
Xxxxxx, Xxxxx 00000-0000
Phone: (000) 000-0000
Fax: (000) 000-0000
or in the case of UNTHSC to:
UNTHSC
Xxxxxxxx Xxxxx, D.O.
Vice President for Health Affairs & Executive Xxxx
0000 Xxxx Xxxxx Xxxxxxxxx
Xxxx Xxxxx, Xxxxx 00000
Phone: (000) 000-0000
Fax: (000 )000-0000
with a copy to:
UNTHSC
Xxxxxxxx Xxxxx
Associate General Counsel
Office of Legal Affairs
0000 Xxxx Xxxxx Xxxxxxxxx
Xxxx Xxxxx, Xxxxx 00000
Phone: (000) 000-0000
Fax: (000) 000-0000
or in the case of LICENSEE to:
J. Xxxxxxx Xxxxxxx
Myogen, Inc.
0000 X. 000x Xxxxxx
Xxxxx 000
Xxxxxxxxxxx, XX 00000-0000
Phone: (000) 000-0000
Fax: (000) 000-0000
or such other address as may be given from time to time under the terms of this
notice provision.
16.3 Each party shall comply with all applicable federal, state and local
laws, regulations, and ordinances in connection with its activities pursuant to
this AGREEMENT.
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16.4 This AGREEMENT shall be construed and enforced in accordance with the
laws of the United States of America and of the State of Texas.
16.5 Failure of either party to enforce a right under this AGREEMENT shall
not act as a waiver of that right or the ability to later assert that right
relative to the particular situation involved.
16.6 Headings included herein are for convenience only and shall not be
used to construe this AGREEMENT.
16.7 If any part of this AGREEMENT is for any reason found to be
unenforceable, all other parts nevertheless remain enforceable.
16.8 This AGREEMENT may be executed in counterparts, including by
facsimile transmission, each of which shall be deemed an original, but all of
which together shall constitute one and the same instrument.
(REMAINDER OF THIS PAGE INTENTIONALLY LEFT BLANK.)
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IN WITNESS WHEREOF, parties hereto have caused their duly authorized
representatives to execute this AGREEMENT.
UNIVERSITY OF TEXAS SYSTEM MYOGEN, INC.
By: /s/ Xxxxx X. Xxxxxxxxxx By: /s/ J. Xxxxxxx Xxxxxxx
---------------------------- --------------------------
Xxxxx X. Xxxxxxxxxx, Ph.D. J. Xxxxxxx Xxxxxxx
Executive Vice President for CEO and President
Business Affairs
Date: 3-13-00 Date: 1-15-00
-------------------------- ------------------------
APPROVED AS TO FORM: MANTEX BIOTECH, INC.
UT SYSTEM
By: /s/ Xxxxxxx Xxxxxx By: /s/ Xxxxxx Xxxxxxx
---------------------------- --------------------------
Xxxxxxx Xxxxxx Xxxxxx X. Xxxxxxx
Office General Counsel President
Date: 3-3-00 Date: 1-13-00
-------------------------- ------------------------
THE UNIVERSITY OF NORTH TEXAS
APPROVED AS TO CONTENT: HEALTH SCIENCE CENTER AT FORT
UT SOUTHWESTERN WORTH
By: /s/ Xxxxxx Xxxxx By: /s/ Xxxxxxxx X. Xxxxx
---------------------------- --------------------------
Xxxxxx X. Xxxxx, M.D. Xxxxxxxx Xxxxx, D.O.
Vice President for Vice President for Health Affairs
Technology Development & Executive Xxxx
Date: 3-13-00 Date: 2-21-00
-------------------------- ------------------------
By: /s/ Xxxxx X. Xxxxxxx
--------------------------
Xxxxx X. Xxxxxxx
Vice President for Fiscal Affairs
Date: 2-22-00
------------------------
APPROVED AS TO FORM:
UNTHSC
By: /s/ S. Xxxxxxxx Xxxxx
--------------------------
Xxxxxxxx Xxxxx
Associate General Counsel
Date: 2-25-00
------------------------
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--------------------------------------------------------------------------------
(TAB 5.)
--------------------------------------------------------------------------------
ATTACHMENT A, EXHIBIT A.
PATENT AND PATENT APPLICATIONS
SIGNATURES: None
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EXHIBIT A
PATENTS AND PATENT APPLICATIONS
[-#-]
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