EXHIBIT 10.21
[*#*] 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 406
OF THE SECURITIES ACT OF 1933, AS AMENDED.
PATENT AND TECHNOLOGY LICENSE AGREEMENT
BETWEEN UNIVERSITY OF TEXAS SYSTEM
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, 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 owns 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;
B. BOARD desires to have the LICENSED SUBJECT MATTER developed and used
on the terms and conditions provided for herein for the benefit of LICENSEE, the
INVENTOR, BOARD, UT SOUTHWESTERN and the public as outlined in BOARD'S
Intellectual Property Policy;
C. LICENSEE wishes to obtain a license from BOARD to practice LICENSED
SUBJECT MATTER;
D. LICENSEE intends to sponsor research relating to LICENSED SUBJECT
MATTER at UT SOUTHWESTERN to further develop LICENSED SUBJECT MATTER and to
identify related technologies and will execute a SPONSORED RESEARCH AGREEMENT in
the form attached hereto as Exhibit B concurrently with the execution of this
AGREEMENT;
NOW, THEREFORE, in consideration of the mutual covenants and premises
herein contained, the parties hereto agree as follows:
1. EFFECTIVE DATE
This AGREEMENT is effective December 1, 1999 (EFFECTIVE DATE).
2. 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
Page 1 of 18
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 INVENTOR means Xxxx Xxxxx, Ph.D., Professor, UT SOUTHWESTERN.
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; (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; 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.
2.5 LICENSED PRODUCT means any compound, assay, method, reagent,
technology, or product comprising LICENSED SUBJECT MATTER pursuant to this
AGREEMENT.
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 sublicensee 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
sublicensee 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
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[*#*] CONFIDENTIAL TREATMENT REQUESTED
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 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 and/or
other sums 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 BOARD'S rights in information or discoveries
covered by a VALID CLAIM as defined in Section 2.16 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: (i) set forth in Exhibit A; or (ii)
discovered, conceived and/or reduced to practice during or as a result of the
SPONSORED RESEARCH AGREEMENT.
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 SPONSORED RESEARCH means research conducted by or under the direct
supervision of INVENTOR pursuant to the SPONSORED RESEARCH AGREEMENT between
BOARD and LICENSEE dated December 1, 1999, and attached hereto as Exhibit B.
2.14 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 and/or other sums paid by a sublicensee; and (vi) any
sums paid by a sublicensee to LICENSEE in the form of a milestone payment during
the development of LICENSED PRODUCTS.
2.15 TECHNOLOGY RIGHTS means BOARD'S rights in technical information,
know-how, processes, procedures, compositions, devices, methods, formulas,
protocols, techniques, software, designs, drawings or data created by INVENTOR
at UT SOUTHWESTERN before or during the term of the SPONSORED RESEARCH AGREEMENT
relating to LICENSED SUBJECT MATTER which are not covered by PATENT RIGHTS but
which are necessary or useful for practicing the invention covered by PATENT
RIGHTS and are not obligated to any other third party.
2.16 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.
3. WARRANTY; SUPERIOR-RIGHTS
3.1 Except for the rights, if any, of the Government of the United
States, as set forth below, BOARD represents and warrants to the best of its
knowledge that it is the owner of the entire right, title, and interest in and
to LICENSED SUBJECT MATTER, and that it has the sole right to grant licenses
thereunder, and it has not knowingly granted licenses thereunder to any other
entity that would restrict rights granted to LICENSEE except as stated herein.
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.
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[*#*] CONFIDENTIAL TREATMENT REQUESTED
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, 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, 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 in the LICENSED FIELD, nor does BOARD 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.
3.4 LICENSEE, by execution hereof, acknowledges, covenants and agrees
that it has not been induced in anyway by BOARD, 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.
4. LICENSE
4.1 BOARD hereby grants 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 of all consideration as
provided in this AGREEMENT, and shall be further subject to rights retained by
BOARD 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, provided, however, INVENTOR
subject to the SPONSORED RESEARCH AGREEMENT, shall disclose pending
publications to LICENSEE in accordance with Section 6.1 of the
SPONSORED RESEARCH AGREEMENT; 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 hereunder whether or not such amounts are paid
to LICENSEE by a sublicensee. LICENSEE must deliver to BOARD a true
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[*#*] CONFIDENTIAL TREATMENT REQUESTED
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.
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
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 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 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 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 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.
4.5 For [*#*] commencing with the EFFECTIVE DATE, BOARD grants LICENSEE
an exclusive option to negotiate [*#*] license for inventions, discoveries and
intellectual properties related to LICENSED SUBJECT MATTER that were developed
by INVENTOR (i) which result from research conducted under funding sources other
than the SPONSORED RESEARCH AGREEMENT and (ii) which are not otherwise obligated
to any other third party. Such exclusive right to negotiate such licenses will
extend for a 60 day period commencing with receipt by LICENSEE of a written
description of the invention, such description to be provided by UT
SOUTHWESTERN. If LICENSEE and UT SOUTHWESTERN fail to execute [*#*] license
agreement for such invention during this 60 day period, LICENSEE will for an
additional [*#*] option period retain the right to obtain [*#*] license for such
invention [*#*]. Upon UT SOUTHWESTERN'S written notification to LICENSEE of any
such new proposal, LICENSEE shall have 10 days to notify UT SOUTHWESTERN of its
election.
5. PAYMENTS AND REPORTS
5.1 In consideration of rights granted by BOARD to LICENSEE under this
AGREEMENT, LICENSEE agrees to pay the following:
(a) An initial license fee of [*#*] due and payable within 30
days of the EFFECTIVE DATE.
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[*#*] CONFIDENTIAL TREATMENT REQUESTED
(b) An annual license fee of [*#*] due and payable within 30
days of each anniversary of the EFFECTIVE DATE beginning on the later
of (i) [*#*];
(c) 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.
(d) A running earned royalty equal to [*#*] of NET SALES of
any and all LICENSED PRODUCTS covered by PATENT RIGHTS, and/or
IDENTIFIED PRODUCTS;
(e) In the event that any LICENSED PRODUCT or IDENTIFIED
PRODUCT is covered by PATENT RIGHTS which are determined to have been
co-invented by Dr. Xxxxxxx Xxxxx of the University of North Texas
Health Science Center (UNTHSC) and INVENTOR, and such co-invention
occurred as a direct result of sponsored research funding provided by
LICENSEE to both UNTHSC and UTSW, then (i) the milestone payments due
UNTHSC for that certain LICENSED PRODUCT or IDENTIFIED PRODUCT, will be
creditable against milestone payments due BOARD as set forth in (c)
above, [*#*] and (ii) the royalty payments due UNTHSC for that certain
LICENSED PRODUCT or IDENTIFIED PRODUCT, will be creditable against
royalty payments due BOARD as set forth in (d) above, [*#*]
(f) [*#*] of any and all revenues from either SUBLICENSE
REVENUES or NON-SUBLICENSEE CORPORATE PARTNERSHIP REVENUES, whichever
applies;
(g) [*#*]
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
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[*#*] CONFIDENTIAL TREATMENT REQUESTED
permit an independent certified public accountant selected by BOARD 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 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 (v) the amount of SUBLICENSE REVENUES and
NON-SUBLICENSEE CORPORATE PARTNERSHIP REVENUES received and the amounts of such
revenues due BOARD.
Simultaneously with the delivery of each such report, LICENSEE shall pay to
BOARD 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 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
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.
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[*#*] CONFIDENTIAL TREATMENT REQUESTED
(c) The initial contact person for LICENSEE shall be J.
Xxxxxxx Xxxxxxx, CEO and President, Myogen Inc., 0000 X. 000x Xxxxxx,
Xxxxx 000, Xxxxxxxxxxx, Xxxxxxxx 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.
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.
6. STOCK; EQUITY OWNERSHIP
6.1 In consideration of the rights granted to LICENSEE by BOARD in this
AGREEMENT, LICENSEE agrees to issue to BOARD 482,163 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"). BOARD
and UT SOUTHWESTERN will notify LICENSEE within 30 days after receipt of BOARD'S
approval of this AGREEMENT and will issue written instructions to LICENSEE
detailing the procedure and guidelines for distributing stock to BOARD and
INVENTOR, as set forth in the Board of Regent's Rules and Regulations regarding
intellectual property. These shares of preferred stock will be distributed by
LICENSEE within 30 days after receiving such instructions.
6.2 In addition, LICENSEE hereby grants BOARD a warrant for the
purchase of 175,000 shares of its common stock as set forth in the Warrant
attached to the Stock Purchase Agreement as Exhibit E.
6.3 The BOARD may have one representative attend meetings of the
LICENSEE'S Board of Directors in a non-voting capacity and at his or her own
expense; provided that such representative signs an agreement in the form
provided by LICENSEE not to disclose the matters discussed at such meetings, and
that LICENSEE shall have the right to exclude such representative as LICENSEE
and its counsel reasonably deems necessary to protect LICENSEE'S attorney-client
privilege or LICENSEE'S interests.
7. SPONSORED RESEARCH
LICENSEE and BOARD have entered into, concurrently with this AGREEMENT,
a SPONSORED RESEARCH AGREEMENT attached hereto as Exhibit B.
8. 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 from
revenues LICENSEE may have in the future derived
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[*#*] CONFIDENTIAL TREATMENT REQUESTED
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, 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, stating the manner of the
cure; or
(e) at any time upon the mutual written agreement of LICENSEE,
UT SOUTHWESTERN and BOARD, and subject to any terms herein which
survive termination.
8.3 Any time after the later of either 4 years from the EFFECTIVE DATE,
or 1 year following the termination of the SPONSORED RESEARCH AGREEMENT, BOARD
and UT SOUTHWESTERN have the right to terminate the exclusivity of this license
in the LICENSED TERRITORY if LICENSEE, within 60 days after receiving written
notice from UT SOUTHWESTERN 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,
or 2 years following the termination of the SPONSORED RESEARCH AGREEMENT, BOARD
and UT SOUTHWESTERN have the right to terminate this license in the LICENSED
TERRITORY if LICENSEE, within 60 days after receiving written notice from UT
SOUTHWESTERN 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 If the SPONSORED RESEARCH AGREEMENT is terminated prior to its
expiration date by LICENSEE for any reason other than material breach by BOARD
and/or INVENTOR, BOARD may terminate this AGREEMENT unless LICENSEE pays all
funds remaining due under the terms of the SPONSORED RESEARCH AGREEMENT within
30 days of written notice by BOARD of its intent to terminate the AGREEMENT.
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8.6 Written evidence provided by LICENSEE that [*#*] shall be deemed
satisfactory evidence for purposes of this Article VIII.
8.7 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.
9. INFRINGEMENT BY THIRD PARTIES
9.1 LICENSEE and BOARD 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 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.
10. ASSIGNMENT
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, which will
not be unreasonably withheld. A written decision regarding LICENSEE'S request
for BOARD'S consent to such assignment will be provided to LICENSEE within 5
days of receipt by BOARD of written notice from LICENSEE of the proposed
assignment.
11. 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.
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12. INDEMNIFICATION
LICENSEE agrees to hold harmless and indemnify BOARD, INVENTOR, SYSTEM,
UT SOUTHWESTERN, its 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.
13. USE OF NAME
LICENSEE shall not use the name of UT SOUTHWESTERN, SYSTEM, BOARD or
their Regents, employees or agents without express prior written consent except
as required by governmental law, rule or regulation.
14. CONFIDENTIAL INFORMATION
14.1 BOARD 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, it's 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;
(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,
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[*#*] CONFIDENTIAL TREATMENT REQUESTED
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.
15. PATENTS AND INVENTIONS
15.1 BOARD retains 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 INVENTOR at
UT SOUTHWESTERN, 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 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 with a copy of any and all patent applications
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 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 that it does not intend to pay costs
associated with any patent application in the United States or any foreign
country which UT SOUTHWESTERN believes should be prepared and filed, then UT
SOUTHWESTERN may file such application at its 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 [*#*].
16. GENERAL
16.1 This AGREEMENT and the SPONSORED RESEARCH AGREEMENT (Exhibit B)
constitute the entire and only agreements between the parties with regard to
LICENSED SUBJECT MATTER and all other prior negotiations, representations,
agreements, and
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[*#*] CONFIDENTIAL TREATMENT REQUESTED
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
Xxxxxx, Xxxxx 00000-0000
Phone: (000)000-0000
Fax: (000)000-0000
and UT SOUTHWESTERN
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 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.
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[*#*] CONFIDENTIAL TREATMENT REQUESTED
IN WITNESS WHEREOF, parties hereto have caused their duly authorized
representatives to execute this AGREEMENT.
UNIVERSITY OF TEXAS SYSTEM MYOGEN INC.
By /s/ P H Xxxxxxxxxx By /s/ J. Xxxxxxx Xxxxxxx
--------------------------------------- ---------------------------------
Xxxxx X. Xxxxxxxxxx, Ph.D. J. Xxxxxxx Xxxxxxx
Executive Vice President for CEO and President
Business Affairs
Date: DEC 22 1999 Date: 12-1-99
----------------------------- ------------------------------
APPROVED AS TO FORM:
UT SYSTEM
By /s/ Xxxxxxx Xxxxxx
---------------------------------------
Xxxxxxx Xxxxxx
Office of General Counsel
Reviewed and approved
/s/ B. Maxway
-----------------------------------
Date: 12/13/99 Date: 13 Dec 99
------------------------------------ --------------------------
APPROVED AS TO CONTENT:
By /s/ Xxxxxx X. Xxxxx MD
---------------------------------------
Xxxxxx X. Xxxxx, M.D.
Vice President for
Technology Development
Date: 8 December 1999
------------------------------------
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[*#*] CONFIDENTIAL TREATMENT REQUESTED
EXHIBIT A
PATENTS AND PATENT APPLICATIONS
[*#*]
[*#*] CONFIDENTIAL TREATMENT REQUESTED
EXHIBIT B
SPONSORED RESEARCH AGREEMENT
[*#*] CONFIDENTIAL TREATMENT REQUESTED
SPONSORED RESEARCH AGREEMENT
This Sponsored Research Agreement (the "Agreement") is made between The
University of Texas Southwestern Medical Center at Dallas ("University"), a
component institution of The University of Texas System ("System") which is
governed by the University of Texas System Board of Regents ("Board") and
Myogen, Inc., a Delaware corporation with its principal place of business at
0000 X. 000xx Xxx., Xxxxx 000, Xxxxxxxxxxxx, XX 00000-0000 ("Sponsor").
RECITALS
A. Sponsor and Board will enter into a license agreement concurrently
dated Dec. 1, 1999 (the "License Agreement"), pursuant to which the Board grants
Sponsor certain license's under inventions, discoveries and related intellectual
property rights; and
B. Sponsor desires that University perform certain research hereinafter
described and is willing to advance funds to sponsor such research; and
C. Sponsor desires to obtain certain rights to inventions, discoveries
and intellectual property developed during the course of such research with a
view to profitable commercialization of such intellectual property for the
Sponsor's benefit; and
D. University is willing to perform such research and to grant certain
rights to such intellectual property pursuant to this Agreement and the License
Agreement.
1. EFFECTIVE DATE
This Agreement shall be effective as of December 1, 1999 (the
"Effective Date").
2. RESEARCH PROGRAM
2.1 University will conduct the research program summarized in general
terms in Attachment A (the "Research Program"), to be amended and expanded from
time to time by the mutual written agreement of the Principal Investigator and a
representative or representatives of Sponsor designated for such purpose, and
will furnish the facilities necessary to carry out the Research Program. The
Research Program will be under the direction of Dr. Xxxx Xxxxx or his successor
as mutually agreed to by the parties (the "Principal Investigator") and will be
conducted by the Principal Investigator at the University. If University cannot
propose a successor to Dr. Xxxx Xxxxx who is reasonably acceptable to Sponsor,
Sponsor shall have the right to terminate the Agreement pursuant to Section
11.2.
2.2 The Research Program shall be performed during the period from the
Effective Date through and including the date which is three (3) years after the
Effective Date hereof ("Term").
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[*#*] CONFIDENTIAL TREATMENT REQUESTED
2.3 Sponsor understands that University's mission is advancement of
knowledge, education, and patient care and, consequently, the Research Program
will be designed to carry out that mission. The manner of performance of the
Research Program shall be determined solely by the Principal Investigator using
good faith, diligent efforts, in consultation with Sponsor. University does not
guarantee specific results.
2.4 Sponsor understands that University may be involved in similar
research through other researchers on behalf of itself and others. University
shall be free to continue such research provided that it is conducted separately
and by different investigators from the Research Program, and Sponsor shall not
gain any rights via this Agreement to such other research.
2.5 University does not guarantee that any intellectual property rights
will result from the Research Program, that the scope of any intellectual
property rights obtained will cover Sponsor's commercial interest, or that any
such intellectual property rights will be free of dominance by others
independent of the Research Program.
3. COMPENSATION
3.1 As consideration for the performance by University of its
obligations under this Agreement, Sponsor will pay the University the amount of
[*#*]. Sponsor shall make equal quarterly advance payments [*#*] each beginning
[*#*] and continuing through the Term of the Agreement. [*#*].
3.2 University shall maintain all Research Program funds in a separate
account and shall expend such funds for wages, supplies, equipment, travel, and
other operation expenses in connection with the Research Program. It is
understood that any funds in this separate account at the conclusion of the
Research Program shall be retained by University.
3.3 University shall retain title to all equipment purchased and/or
fabricated by it with funds provided by Sponsor under this Agreement.
4. CONSULTATION AND REPORTS
4.1 Sponsor's designated representative for consultation and
communications with the Principal Investigator shall be Sponsor's Vice President
of Research and Development or such other person as Sponsor may from time to
time designate in writing to University and the Principal Investigator
("Designated Representative").
4.2 During the Term of the Agreement, Sponsor's representatives may
consult informally with University's representatives regarding the project, both
personally and by telephone. Access to work carried on in University
laboratories in the course of these investigations shall be entirely under the
control of University personnel but shall be made available to Sponsor's
representatives on a reasonable basis.
4.3 The Principal Investigator will make up to two (2) oral reports
each year as requested by Sponsor's Designated Representative. In addition, at
the conclusion of each calendar quarter and each year, the Principal
Investigator shall submit to Sponsor a written report summarizing the work. The
Principal Investigator shall also submit a comprehensive final report within one
hundred twenty (120) days of termination of the Agreement which shall contain,
but which need not be limited to, the following information:
a. A summary of expenses of the Research Program; and,
b. A report of the activities undertaken and accomplishments
achieved by the University under the Research Program.
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5. PUBLICITY
Subject to Article 6 below, neither party shall make reference to the
other in a press release or any other written statement in connection with work
performed under this Agreement, if it is intended for use in the public media,
except as required by The Texas Public Information Act or other law or
regulation. University, however, shall acknowledge Sponsor's support of the
investigations under this Agreement in scientific or academic publications and
other scientific or academic communications, subject to Sponsor's prior
approval. In any such statements, the parties shall describe the scope and
nature of their participation accurately and appropriately.
6. PUBLICATION AND ACADEMIC RIGHTS
6.1 University and Principal Investigator have the right to publish or
otherwise publicly disclose information gained in the course of this Agreement.
In order to avoid loss of patent rights as a result of premature public
disclosure of information concerning a patentable invention, University will
submit any and all materials to Sponsor for review and comment at least sixty
(60) days prior to planned submission for publication. Sponsor shall notify
University within thirty (30) days of receipt of such materials whether it
desires University to file patent applications on any inventions contained in
the materials; and, if requested by Sponsor to do so, University will proceed to
file a patent application in due course, and in any event within sixty (60) days
of the date of such request. Expenses related to the prosecution of such
patent(s) are to be paid by Sponsor as set forth in Article XV of the License
Agreement (as defined below in Article 8.2). For a period ending on the day
which is sixty (60) days after the date that Sponsor provides notice to
University that it desires University to file such patent application, neither
University nor Principal Investigator shall disclose any such information.
Subject to the foregoing, University shall have the final authority to determine
the scope and content of any publications.
6.2 It is understood that the Principal Investigator may desire to
discuss the research being performed under this Agreement with other University
investigators. Principal Investigator may discuss the research only with those
University investigators who have signed an agreement substantially in the form
attached hereto as Attachment B, pursuant to which such University investigator
agrees to protect Sponsor's confidential information, and discloses the names of
any sponsors who could be entitled to or claim an interest in the results of the
University investigator's research in the event such University investigator may
be considered an inventor on any inventions or discoveries resulting from the
Research Program. University shall ensure that Principal Investigator shall not,
and Principal Investigator shall not, reveal to any party information which is
Sponsor's Confidential Information under Article 7, nor shall the University or
Principal Investigator involve any person in the performance of the research
being performed pursuant to this Agreement, other than such persons as the
Sponsor agrees, in writing, may be so involved. In the event any joint
inventions result from discussions with University investigators permitted under
this Section 6.2, University shall grant to Sponsor the rights outlined in
Article 8 of this Agreement, to the extent such grant is not in conflict with
the other University investigator's obligations to another party as a result of
the involvement of the other investigator(s). If there is a conflict between the
rights outlined in Article 8 and the University investigator's obligations to
another party, University shall use commercially reasonable good faith efforts
to apportion the rights to any such joint invention between the Sponsor and the
University investigator's third party sponsors in a reasonable and equitable
manner.
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[*#*] CONFIDENTIAL TREATMENT REQUESTED
7. CONFIDENTIAL INFORMATION
7.1 Subject to the terms of this Article 7, University and Sponsor each
agree, for the Term and 3 years thereafter, that all information in the Research
Plan and all information contained in documents marked "confidential" and
forwarded to one by the other ("Confidential Information"): (i) are to be
received in strict confidence, (ii) are to be used only for the purposes of this
performance of the Research Program, 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 by
competent written proof that the 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, it's 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;
e. was independently developed by the recipient; or
f. is required by law or regulation to be disclosed.
7.2 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 to allow such party to assert whatever exclusions or exemptions may
be available to it under such law or regulation. Sponsor 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 Sponsor.
7.3 Each party's obligation of confidence under this Article 7 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.
8. PATENTS, COPYRIGHTS, AND TECHNOLOGY RIGHTS
8.1 University represents and warrants that all inventions and
discoveries, and all related Intellectual Property Rights (as defined below)
shall be assigned to and owned by the Board. Such inventions, discoveries and
Intellectual Property Rights are and shall be licensed to Sponsor pursuant to
the terms set forth in the License Agreement.
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[*#*] CONFIDENTIAL TREATMENT REQUESTED
8.2 As used in this Section 8, the term:
"Intellectual Property Rights" means, collectively, all trade-xxxx,
tradename, industrial design, copyright or other industrial, intellectual or
proprietary rights resulting from activities conducted by University personnel
(including without limitation the Principal Investigator) pursuant to the
Research Program, including without limitation all Patent Rights and Know-How;
provided, however, that subject to Section 6.2, it shall not include any
intellectual or proprietary rights which are owned by or contractually obligated
to a third party;
"Know-How" means, collectively, all trade secrets, research,
development and manufacturing data, inventions technical, engineering and
scientific information, methods, processes, procedures, techniques, discoveries,
protocols, formulas, designs, drawings, specifications and know-how or other
information resulting from activities conducted by University personnel
(including without limitation the Principal Investigator) pursuant to the
Research Program, whether or not patentable, copyrightable or otherwise
protected by law or commercially useful or reducible to writing or practice; and
"Patent Rights" has the meaning ascribed thereto in the License
Agreement.
8.3 Prosecution, maintenance and enforcement of any and all Patent
Rights and any other Intellectual Property Rights shall be governed by the terms
of the License Agreement.
9. LIABILITY
9.1 Sponsor agrees to indemnify and hold harmless System, University,
their Regents, officers, agents and employees (collectively, the "Indemnitees")
from any liability, loss or damage (collectively, "Losses") they may suffer as a
result of claims, demands, costs or judgments against them arising out of the
activities to be carried out pursuant to the terms of this Agreement, including
but not limited to the use by Sponsor of the results obtained from the
activities performed by University under this Agreement; provided, however,
Sponsor shall not be obligated to indemnify or hold harmless the Indemnitees for
any Losses they or any of them may suffer, where such Losses were the result of:
a. the failure of System, University or Principal Investigator to
comply with any applicable FDA or other governmental law,
regulation or requirement;
b. the negligence or willful malfeasance of Principal
Investigator, University, System or any Regent, officer, agent
or employee of University or System; or
c. the infringement of the intellectual property or other
property rights of any third party by Principal Investigator,
University, or any officer, agent or employee of University or
System.
9.2 Both parties agree that upon receipt of a notice of claim or action
arising out of the activities to be carried out pursuant to the project
described in Attachment A, the party receiving such notice will notify the other
party promptly. Sponsor agrees, at its own expense, to provide attorneys to
defend against any actions brought or filed against University, System, their
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[*#*] CONFIDENTIAL TREATMENT REQUESTED
Regents, officers, agents and/or employees with respect to the subject of the
indemnity contained herein, whether such claims or actions are rightfully
brought or filed; and subject to the statutory duty of The Texas Attorney
General, University agrees to cooperate with Sponsor in the defense of such
claim or action.
10. INDEPENDENT CONTRACTOR
For the purposes of this Agreement and all services to be provided
hereunder, the parties shall be, and shall be deemed to be, independent
contractors and not agents or employees of the other party. Neither party shall
have authority to make any statements, representations or commitments of any
kind, or to take any action which shall be binding on the other party, except as
may be expressly provided for herein or authorized in writing.
11. TERM AND TERMINATION
11.1 This Agreement shall commence on the Effective Date and extend
until the end of the Term as defined in Section 2.2, unless sooner terminated in
accordance with the provisions of this Section 11.
11.2 This Agreement may be terminated by the written agreement of both
parties. In addition, Sponsor shall have the right, at its sole discretion, to
terminate its funding of the Research Program and this Agreement: (a) upon 30
days notice if University cannot find a successor to Xx. Xxxxx reasonably
acceptable to Sponsor pursuant to Section 2.1, provided that Sponsor will be
liable for any non-cancelable financial obligations reasonably incurred by
University for the performance of the Research Program, or (b) upon 90 days
written notice (a "Termination Notice") to University asserting that for reasons
stated, Sponsor deems that unsatisfactory progress by the Principal Investigator
is being made on the Research Program, provided that any Termination Notice
under Section 11.2(b) may only be given after the end of the third calendar
quarter of the first year of the Term. Upon receipt of a Termination Notice
pursuant to Section 11.2(b), University shall have the right during such 90 day
notice period to correct the conditions stated in the Termination Notice which
Sponsor deems to constitute such unsatisfactory progress. In the event
University corrects such conditions during such 90 day period, the Agreement
shall not terminate. In the event University is unable to correct such
conditions during the 90 day period, the Agreement shall terminate at the
conclusion of the 90 day notice period.
11.3 This Agreement will earlier terminate:
(1) automatically if any payment or report obligation of
Sponsor under this Agreement is received by University more than 60
days after Sponsor receives written notice that such payment(s) are in
arrears, unless, before the end of the 60 day period, Sponsor has cured
the breach or default and so notifies University, stating the manner of
the cure; or
(2) upon 90 days written notice if Sponsor materially breaches
or defaults on any other obligation under this Agreement, unless,
before- the end of the 90 day period, Sponsor has cured the breach or
default and so notifies University, stating the manner of the cure.
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11.4 Termination or cancellation of this Agreement shall not affect the
rights and obligations of the parties accrued prior to termination, or Sponsor's
rights under the License Agreement (except as provided in Article 8 of the
License Agreement). In accordance with Section 8.5 of the License Agreement,
upon termination (other than a termination of this Agreement as a result of the
expiration of the Term or any renewal term thereof), Sponsor may, at its sole
discretion, elect to [*#*] which case the License Agreement shall continue as
provided in Section 8.5 of the License Agreement.
11.5 The obligations of the parties which are contained in Sections 4,
6, 7, 8 and 9 shall survive termination of this Agreement. If for any reason
this Agreement survives the termination of the License Agreement, the parties
shall meet and discuss in good faith the terms under which Sponsor may obtain
rights in the inventions, discoveries and related Intellectual Property Rights
developed under the Research Program during the Term, which terms shall be no
less favorable to Sponsor than those provided in the License Agreement.
12. ATTACHMENTS
Attachment A is incorporated and made a part of this Agreement for all
purposes.
13. GENERAL
13.1 This Agreement may not be assigned by Sponsor without the prior
written consent of University, such approval not to be unreasonably withheld.
However, this agreement shall survive merger or acquisition of Sponsor and shall
be subject to written approval by University, such approval not to be
unreasonably withheld. A written decision regarding Sponsor's request for
University's consent to such assignment will be provided to Sponsor within 5
days of receipt by University of written notice from Sponsor of the proposed
assignment.
13.2 This Agreement, along with the License Agreement, constitute the
entire and only agreements between the parties relating to the Research Program,
and all 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.
13.3 In the event of a conflict between the License Agreement and this
Agreement, the terms of the License Agreement shall control.
13.4 Any notice required or permitted by this Agreement shall be given
by prepaid, first class, certified mail, return receipt requested, or by
facsimile, addressed in the case of University to:
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[*#*] CONFIDENTIAL TREATMENT REQUESTED
The University of Texas System
000 Xxxx 0xx Xxxxxx
Xxxxxx, XX 00000
Attention: Office of General Counsel
FAX: (000) 000-0000
PHONE: (000) 000-0000
The University of Texas Southwestern
Medical Center at Dallas
0000 Xxxxx Xxxxx Xxxx.
Xxxxxx, XX 00000-0000
ATTN: Xxxxxx Xxxxxx
Director, Contracts Management
FAX: (000) 000-0000
PHONE: (000) 000-0000
or in the case of Sponsor to:
Myogen, Inc.
0000 X. 000xx Xxx., Xxxxx 000
Xxxxxxxxxxxx, XX 00000-0000
ATTN: J. Xxxxxxx Xxxxxxx
FAX: (000) 000-0000
PHONE: (000) 000-0000
or at such other addresses as may be given from time to time in accordance with
the terms of this notice provision.
13.5 This Agreement shall be governed by, construed, and enforced in
accordance with the internal laws of the State of Texas.
13.6 Each party shall comply with all applicable federal, state and
local laws, regulations, and ordinances in connection with its activities
pursuant to this Agreement.
13.7 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.
13.8 If any part of this Agreement is for any reason found to be
unenforceable, all other parts nevertheless remain enforceable.
13.9 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.
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[*#*] CONFIDENTIAL TREATMENT REQUESTED
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed by their duly authorized representatives.
THE UNIVERSITY OF TEXAS MYOGEN, INC.
SOUTHWESTERN MEDICAL CENTER
AT DALLAS
/s/ P H Xxxxxxxxxx /s/ J. Xxxxxxx Xxxxxxx
------------------------------------- ----------------------------------
Name: Xxxxx X. Xxxxxxxxxx Name: X. Xxxxxxx Fretyag
Title: Executive Vice President Title: CEO and President
for Business Affairs
Date DEC 22 1999 Date 12-1-99
--------------------------------- ------------------------------
As Principal Investigator in this Agreement, I attest that I have read this
Agreement in its entirety, that I consent to the terms herein, and that I shall
use my best efforts to uphold my individual obligations and responsibilities
hereunder.
/s/ Xxxx Xxxxx
-------------------------------------
Dr. Xxxx Xxxxx
Date 12/21/99
---------------------------------
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[*#*] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
AMENDMENT TO SPONSORED RESEARCH AGREEMENT
THIS AMENDMENT (the "Amendment') TO THE SPONSORED RESEARCH AGREEMENT
entered into on or about December 1, 1999 between the University of Texas
Southwestern Medical Center at Dallas (the "University"), a component
institution of The University of Texas System (the "System") which is governed
by the University of Texas System Board of Regents (the "Board") and Myogen,
Inc. ("Sponsor")(the "Agreement") is made and entered into as of December 20,
2001 by and between the University and Sponsor. University and Sponsor wish to
amend the Agreement as set forth herein, to extend the term of the Agreement and
to provide for additional research activities to be funded and conducted under
the Agreement. The parties hereby agree as follows:
1. Recital A of the Agreement shall be amended to read in its entirety as
follows:
"A. Sponsor and Board entered into a Patent and Technology License
Agreement dated on or about December 1, 1999, as amended on or about July 7,
2000 and as further amended on or about December 20, 2001, (the, "License
Agreement"), pursuant to which the Board granted Sponsor certain licenses under
inventions, discoveries and related intellectual property rights; and"
2. Section 2.1 of the Agreement shall be amended to read in its entirety as
follows:
"2.1 University will conduct the research programs summarized in
general terms in Attachment A and Attachment A.1 (collectively the "Research
Program"), to be amended and expanded from time to time by the mutual written
agreement of the Principal Investigator and Sponsor's Vice President of Research
and Development or his designee, and will furnish the facilities necessary to
carry out the Research Program. The Research Program will be under the direction
of Dr. Xxxx Xxxxx or his successor as mutually agreed to by the parties (the
"Principal Investigator") and will be conducted by the Principal Investigator at
the University. If University cannot propose a successor to Dr. Xxxx Xxxxx who
is reasonably acceptable to Sponsor, Sponsor shall have the right to terminate
the Agreement pursuant to Section 11.2."
3. The Agreement shall be amended by the addition of an Attachment A.1, the form
of which is attached hereto as Exhibit A.
4. Section 2.2 of the Agreement shall be amended to read in its entirety as
follows:
"2.2 The Research Program shall be performed during the period from the
Effective Date through and including March 31, 2007 (the "Term")."
5. Section 3.1 of the Agreement shall be amended to read in its entirety as
follows:
"3.1 As consideration for the performance by University of its
obligations under this Agreement, Sponsor will pay the University (a) [/\#/\]
each calendar quarter, beginning the first full calendar quarter following the
Effective Date and continuing through the fourth calendar quarter of 2001 and
(b) [/\#/\]each calendar quarter, beginning the first calendar quarter of 2002
and continuing through the end of the Term, [/\#/\]
Page 1 of 4 [/\#/\] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
6. University acknowledges and agrees that (a) all amounts due and payable under
the Agreement for performance through December 31, 2001 have been paid in full
by Sponsor and (b) Sponsor has made a payment of [/\#/\] to be applied toward
the amount payable to the University for the first calendar quarter of 2002 as
set forth in Section 3.1 of the Agreement.
7. The first sentence of Section 7.1 of the Agreement shall be amended by
replacing the term "Research Plan" with the term "Research Program."
8. The definition of "Intellectual Property Rights" set forth in Section 8.2 of
the Agreement shall be amended to read in its entirety as follows:
"Intellectual Property Rights" means, collectively, all trademark,
tradename, industrial design, copyright or other industrial, intellectual or
proprietary rights resulting from activities conducted by University personnel
(including without limitation the Principal Investigator) pursuant to the
Research Program, including without limitation all Patent Rights and Know-How;
provided, however, that it shall not include any intellectual or proprietary
rights to the extent owned by or contractually obligated to an identified
sponsor of a University investigator approved by Sponsor in writing pursuant to
Section 6.2 above."
9. The first sentence of Section 9.2 of the Agreement shall be amended to read
in its entirety as follows:
"9.2 Both parties agree that upon receipt of a notice of claim or
action arising out of the activities to be carried out pursuant to the Research
Program, the party receiving such notice will notify the other party promptly."
10. Section 11.4 of the Agreement shall be amended to read in its entirety as
follows:
"11.4 Expiration, termination or cancellation of this Agreement shall
not affect the rights and, obligations of the parties accrued prior to such
expiration or termination, or Sponsor's rights under the License Agreement
(except as set forth in Article 8 of the License Agreement)."
11. The first sentence of Section 11.5 of the Agreement shall be amended to read
in its entirety as follows:
"11.5 The rights and obligations of the parties which are contained in
Sections 4, 6, 7, 8, 9, 11.4, 11.5 and 13 shall survive the expiration or
termination of this Agreement."
12. Section 12 of the Agreement shall be amended to read in its entirety as
follows:
"Attachment A, Attachment A.1 and Attachment B are incorporated herein
and made a part of this Agreement for all purposes."
13. Except as expressly amended as set forth in this Amendment, the terms,
conditions and provisions of the Agreement shall continue in full force and
effect as provided therein.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
2 [/\#/\] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
IN WITNESS WHEREOF, University and Sponsor have entered into this
Amendment effective as of the date first set forth above.
THE UNIVERSITY OF TEXAS SOUTHWESTERN MYOGEN, INC.
MEDICAL CENTER AT DALLAS
By /s/ Xxxxxx Xxxxxx By /s/ J. Xxxxxxx Xxxxxxx
--------------------------------------- -----------------------
Xxxxxx X. Xxxxxx, M.D. J. Xxxxxxx Xxxxxxx
Xxxx, Southwestern Medical School President and CEO
Date 3/1/02 Date 2-7-02
Principal Investigator:
/S/ X. XXXXX
---------------------------------------
Dr. Xxxx Xxxxx
2/27/02
---------------------------------------
Date
3 [/\#/\] CONFIDENTIAL TREATMENT REQUESTED
CONFIDENTIAL
Exhibit A
ATTACHMENT A.1
[/\#/\]
4 [/\#/\] CONFIDENTIAL TREATMENT REQUESTED
AMENDMENT NO. 2 TO SPONSORED RESEARCH AGREEMENT
THIS AMENDMENT NO. 2 (the "Amendment") TO THE SPONSORED RESEARCH
AGREEMENT entered into on or about December 1, 1999, as amended December 20,
2001, between the University of Texas Southwestern Medical Center at Dallas (the
"University"), a component institution of The University of Texas System (the
"System") which is governed by the University of Texas System Board of Regents
(the "Board") and Myogen, Inc. ("Sponsor") (the "Agreement") is made and entered
into as of May 20, 2003 by and between the University and Sponsor. University
and Sponsor wish to amend the Agreement as set forth herein, to modify the
payment terms of the research funding to be provided under the Agreement. The
parties hereby agree as follows:
1. Without breach of the Agreement, Sponsor may delay the payment of the amounts
due to the University pursuant to Section 3.1 for the fourth calendar quarter of
2002 and each calendar quarter of 2003; provided that payment of an amount equal
to the total of such delayed payments (three hundred twelve thousand five
hundred dollars) is received by University from Sponsor no later than January
10, 2004.
2. University acknowledges and agrees that all amounts due and payable under the
Agreement for performance through September 30, 2002 have been paid in full by
Sponsor.
3. Except as expressly amended as set forth in this Amendment, the terms,
conditions and provisions of the Agreement shall continue in full force and
effect as provided therein.
IN WITNESS WHEREOF, University and Sponsor have entered into this
Amendment effective as of the date first set forth above.
THE UNIVERSITY OF TEXAS SOUTHWESTERN MYOGEN, INC.
MEDICAL CENTER AT DALLAS
By /s/ Xxxxxx X. Xxxxx By /s/ Xxxxxx X. Xxxxxx
--------------------------------------- -----------------------------------
[Name] Xxxxxx X. Xxxxx, MD Xxxxxx X. Xxxxxx
[Title] Vice President for Technology Vice President, Finance
Date 29 May 03 Date May 20, 2003
---------------------------------------
Principal Investigator:
/s/ X. Xxxxx
------------------------------------------------
Dr. Xxxx Xxxxx
5/27/03
------------------------------------------------
Date
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED
EXHIBIT C
MATERIALS TRANSFER AGREEMENT
[*#*] CONFIDENTIAL TREATMENT REQUESTED
MATERIALS TRANSFER AGREEMENT
The University of Texas Southwestern Medical Center at Dallas agrees to provide
_________________________ with certain materials and know-how for the purposes
stated herein under the following conditions:
1. The parties to this Agreement are: _________________________,
hereinafter referred to as "RECIPIENT", and The University of Texas Southwestern
Medical Center at Dallas, hereinafter referred to as "UT SOUTHWESTERN." The
research (as hereinafter defined) will be conducted by RECIPIENT under the
supervision of _________________________, hereinafter "SCIENTIST".
2. The Material that is covered by this Agreement includes: (a)
______________________________, which was developed by _________________________
of UT SOUTHWESTERN, and (b) any related biological material or associated
know-how and data that will be provided by UT SOUTHWESTERN or received by
SCIENTIST from UT SOUTHWESTERN, hereinafter "Material." The Material is
considered proprietary to UT SOUTHWESTERN. UT SOUTHWESTERN shall be free, in its
sole discretion, to distribute the Material to others and to use it for its own
purposes.
3. The Material shall be used by RECIPIENT in research to study
______________________________, hereinafter "Research."
4. [*#*]
5. [*#*]
6. RECIPIENT agrees that nothing herein shall be deemed to grant to
RECIPIENT or SCIENTIST any rights under any UT SOUTHWESTERN patents or any
rights to use the Material for any products or processes for profit-making or
commercial purposes. The Material will not be used in research that is subject
to consulting or licensing obligations of RECIPIENT or SCIENTIST to another
individual, institution or business entity unless prior written permission is
obtained from UT SOUTHWESTERN.
7. RECIPIENT shall have no rights in the Material other than as
provided in this Agreement. At the request of UT SOUTHWESTERN, RECIPIENT will
return all unused Material.
8. RECIPIENT will inform UT SOUTHWESTERN, in confidence, of results of
Research related to the Material by personal written communication or by
providing UT SOUTHWESTERN with a draft manuscript describing such results. If
RECIPIENT's SCIENTIST desires to publish such Research results in a
noncommercial scientific publication, RECIPIENT will provide UT SOUTHWESTERN
with a copy of any manuscript or abstract disclosing such Research results prior
to submission thereof to a publisher or to any third party, and in any case, not
less than forty-five (45) days prior to any public disclosure, for the purpose
of protecting the Material and any proprietary and intellectual property of UT
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[*#*] CONFIDENTIAL TREATMENT REQUESTED
SOUTHWESTERN that might be disclosed by such publication. In any such
publication, RECIPIENT agrees to acknowledge UT SOUTHWESTERN scientists, as
academically and scientifically appropriate, based on provision of the Material
or other direct contribution to the Research. UT SOUTHWESTERN agrees that it
will acknowledge SCIENTIST'S publications, as academically and scientifically
appropriate, in its publications, which may refer to the results of SCIENTIST'S
Research.
9. The Material is experimental in nature and it is provided WITHOUT
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER
WARRANTY, EXPRESS OR IMPLIED. UT SOUTHWESTERN MAKES NO REPRESENTATION OR
WARRANTY THAT THE USE OF THE MATERIAL WILL NOT INFRINGE ANY PATENT OR OTHER
PROPRIETARY RIGHT.
10. In no event shall UT SOUTHWESTERN be liable for any use by
SCIENTIST or RECIPIENT of the Material or any loss, claim, damage or liability,
of whatsoever kind of nature, which may arise from or in connection with this
Agreement or the use, handling or storage of the Material. Except where limited
by Federal law, or by the constitution and laws of the state governing the
recipient, RECIPIENT agrees to hold harmless The University of Texas System
(hereinafter referred to as System), UT SOUTHWESTERN, their Regents, officers,
agents and employees, from any liability, loss or damage they may suffer as a
result of claims, demands, costs or judgments against them arising out of the
activities to be carried out pursuant to this Agreement and the use by RECIPIENT
of the results obtained from Research.
11. SCIENTIST and RECIPIENT will use the Material in compliance with
all laws, governmental regulations and guidelines applicable to the Material,
[*#*] and when the Material is used in the United States, SCIENTIST will comply
with current NIH guidelines.
12. This Agreement is not assignable, whether by operation of law or
otherwise, without the prior written consent of UT SOUTHWESTERN. This Agreement
represents the entire agreement of the parties with respect to the Materials,
and supersedes all prior understandings and agreements between the parties with
respect thereto.
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[*#*] CONFIDENTIAL TREATMENT REQUESTED
13. This agreement shall be governed by and interpreted in accordance
with the laws of the State of Texas, notwithstanding conflicts of laws
provisions.
THE UNIVERSITY OF TEXAS
SOUTHWESTERN MEDICAL CENTER
AT DALLAS
0000 Xxxxx Xxxxx Xxxxxxxxx
Xxxxxx, Xxxxx 00000
Name:
Title:
Date: Date:
----------------------------------- --------------------------------
READ AND UNDERSTOOD:
---------------------------------
SCIENTIST
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[*#*] CONFIDENTIAL TREATMENT REQUESTED
AMENDMENT NO. 1 TO
PATENT AND TECHNOLOGY LICENSE AGREEMENT
This Amendment No. 1 to
Patent and Technology License Agreement (AMENDMENT) is
made and entered into as of July 7 , 2000 by and between Myogen, Inc. (LICENSEE)
and the Board of Regents (BOARD) of the University of Texas System (SYSTEM).
RECITALS
A. LICENSEE and BOARD entered into a
Patent and Technology License Agreement
effective as of December 1, 1999 (LICENSE AGREEMENT).
B. LICENSEE and BOARD wish to amend the terms of the LICENSE AGREEMENT to revise
and add definitions and to change the option terms for related technologies, as
set forth below.
NOW, THEREFORE, it is hereby agreed as follows:
1. Article II of the LICENSE AGREEMENT shall be deleted in its entirety and
replaced with:
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 ANTISENSE THERAPY means therapeutic use of oligonucleotides or
modified oligonucleotides that bind in a sequence specific manner to DNA or mRNA
2.3 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.
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[*#*] CONFIDENTIAL TREATMENT REQUESTED
2.4 GENE THERAPY means therapeutic use of a designated gene (including
therapeutic use of a homolog or gene product thereof), which may be incorporated
into vectors or other carriers, in a pharmaceutical composition that is
administered by in vivo delivery (i.e. introduced inside the body) or by ex vivo
delivery (i.e. introduced into cells or other complexes outside of the body
which are subsequently introduced into the body). GENE THERAPY specifically
excludes ANTISENSE THERAPY.
2.5 INVENTOR means Xxxx Xxxxx, Ph.D. Professor, UT SOUTHWESTERN.
2.6 LICENSED FIELD means (i) treatment, prevention, diagnosis and/or
prognosis of cardiac hypertrophy and heart failure; and (ii) determination of
predisposition to cardiac hypertrophy and heart failure.
2.7 LICENSED PRODUCT means any compound, assay, method, reagent,
technology, or product comprising LICENSED SUBJECT MATTER pursuant to this
AGREEMENT.
2.8 LICENSED SUBJECT MATTER means inventions and discoveries claimed in
PATENT RIGHTS or covered by TECHNOLOGY RIGHTS within LICENSED FIELD.
2.9 LICENSED TERRITORY means the world.
2.10 NET SALES means the gross revenues received by LICENSEE,
AFFILIATE, NON-SUBLICENSEE CORPORATE PARTNER, and/or any sublicensee from the
SALE of LICENSED PRODUCT'S 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.
2.11 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
sublicensee under the
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[*#*] CONFIDENTIAL TREATMENT REQUESTED
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.
2.12 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 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.
2.13 PATENT RIGHTS means BOARD'S rights in information or discoveries
covered by a VALID CLAIM, as defined in Section 2.17, 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 as (i) set forth in Exhibit A; or (ii)
discovered, conceived and/or reduced to practice during the term of and directly
resulting from the research performed under the SPONSORED RESEARCH AGREEMENT,
and not for use within GENE THERAPY.
2.14 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.
2.15 SPONSORED RESEARCH means research conducted by or under the direct
supervision of INVENTOR pursuant to the SPONSORED RESEARCH AGREEMENT between
BOARD and LICENSEE dated December 1, 1999, and attached hereto as Exhibit B.
2.16 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
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[*#*] CONFIDENTIAL TREATMENT REQUESTED
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 of LICENSED PRODUCTS.
2.17 TECHNOLOGY RIGHTS means BOARD'S rights in technical information,
know-how, processes, procedures, compositions, devices, methods, formulas,
protocols, techniques, software, designs, drawings or data created by INVENTOR
at UT SOUTHWESTERN before or during the term of the SPONSORED RESEARCH AGREEMENT
relating to LICENSED SUBJECT MATTER which are not covered by PATENT RIGHTS but
which are necessary or useful for practicing the invention covered by PATENT
RIGHTS and are not obligated to any other third party.
2.18 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.
2. Section 4.5 shall be deleted in its entirety and replaced with:
4.5 For a [*#*] commencing with the EFFECTIVE DATE, BOARD grants
LICENSEE an exclusive option (OPTION) to negotiate an exclusive,
royalty-bearing, worldwide license for inventions, discoveries and intellectual
properties related to LICENSED SUBJECT MATTER that were developed by INVENTOR at
UT SOUTHWESTERN and: (i) which result from research conducted under funding
sources other than the SPONSORED RESEARCH AGREEMENT; and (ii) which are not
otherwise obligated to any other third party; and (iii) which are not for use
within GENE THERAPY. This exclusive right to negotiate a license will extend for
12 months (OPTION PERIOD) commencing with receipt by LICENSEE of a written
description of the invention from UT SOUTHWESTERN. During the OPTION PERIOD,
LICENSEE will pay all patent expenses incurred by UT SOUTHWESTERN for
inventions, discoveries and intellectual properties included under the OPTION
not to exceed [*#*]. LICENSEE may exercise its option at any time during the
OPTION PERIOD by notifying BOARD and UT SOUTHWESTERN in writing of its intent to
exercise this option. If LICENSEE exercises its OPTION, BOARD and UT
SOUTHWESTERN agree to diligently negotiate with LICENSEE for an exclusive,
royalty-bearing, worldwide license. Such license will provide for a license fee
of [*#*], an annual license reissue fee of [*#*], royalty rate of [*#*] of net
sales, and other reasonable and customary terms as the parties may agree upon.
In the event that the parties are unable to successfully negotiate an exclusive
license agreement within 90 days after LICENSEE exercises its OPTION, either
party may supply the other with written notice of its intent to terminate
license negotiations. If license negotiations are terminated, LICENSEE will, for
an additional 3 month period retain the right to obtain an exclusive, worldwide,
royalty-bearing license for such invention for the same consideration set forth
in any new proposed license agreement that UT SOUTHWESTERN might negotiate with
any other party, provided that the consideration to be provided as part of the
new proposed license
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agreement between UT SOUTHWESTERN and such third party is less than the
consideration offered by LICENSEE in its last proposal before termination of
license negotiations. Upon UT SOUTHWESTERN'S written notification to LICENSEE of
any such new proposal, LICENSEE shall have 10 days to notify UT SOUTHWESTERN of
its election.
3. Section 5.1 shall be deleted in its entirety and replaced with:
5.1 In consideration of rights granted by BOARD to LICENSEE under this
AGREEMENT, LICENSEE agrees to pay the following:
(a) An initial license fee of [*#*] due and payable within 30
days of the EFFECTIVE DATE;
(b) An annual license fee of [*#*] due and payable within 30
days of each anniversary of the EFFECTIVE DATE beginning on the later
of (i) the third anniversary of the EFFECTIVE DATE, or (ii) the first
anniversary of the EFFECTIVE DATE occurring after the termination of
the SPONSORED RESEARCH AGREEMENT;
(c) 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, regardless
of whether the milestone event is performed by LICENSEE, AFFILIATE,
NON-SUBLICENSEE CORPORATE PARTNER, or sublicensee. 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;
(d) A running earned royalty equal to [*#*] of NET SALES of
any and all LICENSED PRODUCTS and/or IDENTIFIED PRODUCTS;
(e) In the event that any LICENSED PRODUCT or IDENTIFIED
PRODUCT is covered by PATENT RIGHT'S which are determined to have been
co-invented by Dr. Xxxxxxx Xxxxx of the University of North Texas
Health Science Center (UNTHSC) and INVENTOR, and such co-invention
occurred as a direct result of sponsored research funding provided by
LICENSEE to both UNTHSC and UT SOUTHWESTERN, then (i) the milestone
payments due UNTHSC for that certain LICENSED PRODUCT or IDENTIFIED
PRODUCT, will be creditable against milestone payments due BOARD as set
forth in (c) above, up to a credit of [*#*] and (ii) the royalty
payments due UNTHSC for that certain LICENSED PRODUCT or IDENTIFIED
PRODUCT, will be creditable
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against royalty payments due BOARD as set forth in (d) above, up to a
credit of [*#*]. In no case will the amount creditable reduce any
milestone or royalty payment due BOARD to less than [*#*] of the amount
due as set forth in (c) and (d) above;
(f) [*#*] of any and all revenues from either SUBLICENSE
REVENUES or NON-SUBLICENSEE CORPORATE PARTNERSHIP REVENUES, whichever
applies; and
(g) If a third party pays to LICENSEE $1 million or more in
consideration for the purchase of an equity interest in LICENSEE in
connection with the execution of an agreement pursuant to which such
third party obtains a sublicense under the PATENT RIGHTS, then LICENSEE
agrees to pay to BOARD a one-time lump sum equal to [*#*]. LICENSEE
shall pay any amount due to BOARD pursuant to this Section 5.1(e)
within 30 days after the execution of documents effecting any such
purchase of an equity interest in LICENSEE by such sublicensee.
4. Exhibit A shall be deleted in its entirety and replaced with:
EXHIBIT A
[*#*]
[*#*]
5. Except as expressly provided in this AMENDMENT, all other terms, conditions
and provisions of the LICENSE AGREEMENT shall continue in full force and effect
as provided therein.
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IN WITNESS WHEREOF, LICENSEE and BOARD have entered into this AMENDMENT
effective as of the date first set forth above.
BOARD OF REGENTS OF THE MYOGEN, INC.
UNIVERSITY OF TEXAS SYSTEM
By /s/ P H Xxxxxxxxxx By /s/ J. Xxxxxxx Xxxxxxx
---------------------------------------------- ---------------------------
Xxxxx X. Xxxxxxxxxx, Ph.D. J. Xxxxxxx Xxxxxxx
Executive Vice President for Business Affairs President and CEO
UT Southwestern Medical Center at Dallas
Date: 7-19-00 Date 7-6-2000
------------------------------------------- -----------------------
Approved as to Form:
By /s/ XxxxXxxx Xxxxxxx
----------------------------------------------
XxxxXxxx Xxxxxxx, Ph.D., X.X.
Office of General Counsel
UT System
Date 13 July 00
--------------------------------------------
Approved as to Content:
By /s/ Xxxxxx X. Xxxxx
----------------------------------------------
Xxxxxx X. Xxxxx, M.D.
Vice President for Technology Development
UT Southwestern Medical Center at Dallas
Date 17 July 2000
--------------------------------------------
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AMENDMENT NO. 2 TO
PATENT AND TECHNOLOGY LICENSE AGREEMENT
This Amendment No. 2 to
Patent and Technology License Agreement (SECOND
AMENDMENT) is made and entered into as of December 20, 2001 by and between
Myogen, Inc. (LICENSEE) and the Board of Regents (BOARD) of the University of
Texas System (SYSTEM).
RECITALS
A. LICENSEE and BOARD entered into a
Patent and Technology License Agreement
effective as of December 1, 1999, and amended as of July 7, 2000 (LICENSE
AGREEMENT).
B. LICENSEE and BOARD wish to further amend the terms of the LICENSE AGREEMENT
to revise and add definitions and extend LICENSEE's option, as set forth below.
NOW, THEREFORE, it is hereby agreed as follows:
1. Section 2.15 of the LICENSE AGREEMENT shall be revised to read in its
entirety as follows:
"2.15 SPONSORED RESEARCH means research conducted by or under the
direct supervision of INVENTOR pursuant to the SPONSORED RESEARCH AGREEMENT.
2. Section 2.17 of the LICENSE AGREEMENT shall be revised to read in its
entirety as follows:
2.17 TECHNOLOGY RIGHTS means BOARD'S rights in technical information,
know-how, processes, procedures, compositions, devices, methods, formulas,
protocols, techniques, software, designs, drawings or data created by INVENTOR
at UT SOUTHWESTERN relating to LICENSED SUBJECT MATTER which are not covered by
PATENT RIGHTS but which are necessary for practicing the PATENT RIGHTS and (i)
were created before the EFFECTIVE DATE; or (ii) are discovered, conceived and/or
reduced to practice during the term of and directly resulting from the research
performed under the SPONSORED RESEARCH AGREEMENT, and not for use within GENE
THERAPY.
3. Article 2 of the LICENSE AGREEMENT shall be amended by the addition of the
following Section 2.19:
"2.19 SPONSORED RESEARCH AGREEMENT means that certain Sponsored
Research Agreement entered into between LICENSEE and UT SOUTHWESTERN concurrent
with this AGREEMENT and effective as of December 1, 1999 in the form attached
hereto as Exhibit B, and as may be amended in writing by the parties from time
to time."
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4. The first sentence of Section 4.5 of the LICENSE AGREEMENT shall be revised
to read in its entirety as follows:
"4.5 For the period commencing with the EFFECTIVE DATE and continuing
through the expiration or termination, whichever is earlier, of the SPONSORED
RESEARCH AGREEMENT, BOARD grants LICENSEE an exclusive option (OPTION) to
negotiate an exclusive, royalty-bearing, worldwide license for inventions,
discoveries and intellectual properties related to LICENSED SUBJECT MATTER that
were developed by INVENTOR at UT SOUTHWESTERN and: (i) which result from
research conducted under funding sources other than the SPONSORED RESEARCH
AGREEMENT; and (ii) which are not otherwise obligated to any other third party;
and (iii) which are not for use within GENE THERAPY.
5. Except as expressly provided in this SECOND AMENDMENT, all other terms,
conditions and provisions of the LICENSE AGREEMENT shall continue in full force
and effect as provided therein.
IN WITNESS WHEREOF, LICENSEE and BOARD have entered into this SECOND AMENDMENT
effective as of the date first set forth above.
BOARD OF REGENTS OF THE MYOGEN, INC.
UNIVERSITY OF TEXAS SYSTEM
By /s/ Xxxx X. Xxxx By /s/ J. Xxxxxxx Xxxxxxx
------------------------------------------------ --------------------------
Xxxx X. Xxxx J. Xxxxxxx Xxxxxxx
Executive Vice President for Business Affairs President and CEO
UT Southwestern Medical Center at Dallas
Date 2/15/02 Date 2-7-02
---------------------------------------------- ------------------------
Approved as to Content:
By /s/ Xxxxxx X. Xxxxx
-----------------------------------------------
Xxxxxx X. Xxxxx, M.D.
Vice President for Technology Development
UT Southwestern Medical Center at Xxxxxx
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