EXHIBIT 10.22
[*#*] 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.
EXCLUSIVE PATENT AND TECHNOLOGY
LICENSE AGREEMENT
BETWEEN
THE UNIVERSITY OF TEXAS SYSTEM
AND
MYOGEN, INC.
TABLE OF CONTENTS
RECITALS PAGE 1
1. EFFECTIVE DATE PAGE 1
2. DEFINITIONS PAGE 1
3. WARRANTY, SUPERIOR RIGHTS PAGE 3
4. LICENSE PAGE 4
5. PAYMENTS AND REPORTS PAGE 5
6. SPONSORED RESEARCH PAGE 7
7. TERM AND TERMINATION PAGE 7
8. INFRINGEMENT BY THIRD PARTIES PAGE 8
9. ASSIGNMENT PAGE 8
10. PATENT MARKING PAGE 9
11. INDEMNIFICATION PAGE 9
12. USE OF NAME PAGE 9
13. CONFIDENTIAL INFORMATION PAGE 9
14. PATENTS AND INVENTIONS PAGE 10
15. GENERAL PAGE 11
SIGNATURES PAGE 13
*#* CONFIDENTIAL TREATMENT REQUESTED
EXCLUSIVE PATENT AND TECHNOLOGY LICENSE AGREEMENT
BETWEEN THE UNIVERSITY OF
TEXAS SYSTEM
AND
MYOGEN, INC.
THIS Agreement (AGREEMENT) is 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 0xx Xxxxxx, Xxxxxx, Xxxxx 00000, on behalf of the University
of
Texas Southwestern Medical Center at Dallas (UT SOUTHWESTERN), a component
institution of SYSTEM, and Myogen, Inc. (LICENSEE), a Delaware corporation
having a principal place of business located at 0000 Xxxx 000xx Xxxxxx, Xxxxx
000, Xxxxxxxxxxx, Xxxxxxxx 00000-0000.
RECITALS
A. BOARD owns certain PATENT RIGHTS (as defined below) and TECHNOLOGY RIGHTS (as
defined below) related to LICENSED SUBJECT MATTER (as defined below), which were
developed at UT SOUTHWESTERN.
B. BOARD desires to have the LICENSED SUBJECT MATTER developed and used for the
benefit of LICENSEE, INVENTOR (as defined below), BOARD, and the public as
outlined in BOARD'S Intellectual Property Policy.
C. BOARD and LICENSEE entered into a Patent and Technology License Agreement
effective December 1, 1999 (1999 AGREEMENT) for a related technology.
D. LICENSEE wishes to obtain a license from BOARD to practice LICENSED SUBJECT
MATTER.
E. 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 the parties will execute a
() in the form attached hereto as Exhibit 2
concurrently with the execution of this AGREEMENT.
NOW, THEREFORE, in consideration of the mutual covenants and premises herein
contained, the parties agree as follows:
1. EFFECTIVE DATE
This AGREEMENT is effective January 1, 2002 (EFFECTIVE DATE).
2. DEFINITIONS
As used in this AGREEMENT, the following terms have the meanings indicated:
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*#* CONFIDENTIAL TREATMENT REQUESTED
2.1 AFFILIATE means any business entity 50% or more owned by LICENSEE, any
business entity which owns 50% or more of LICENSEE, or any business entity that
is 50% or more owned by a business entity that owns 50% or more of LICENSEE.
2.2 IDENTIFIED PRODUCT means any product, or derivative thereof, 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) 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 (as
defined below).
2.3 INVENTOR(S) means X. Xxxxxxx Xxxxxxxx and Xxxxxxx Xxxxxxxxx.
2.4 LICENSED FIELD means: (i) treatment, prevention, diagnosis and/or prognosis
of cardiac hypertrophy, heart disease and heart failure; and (ii) determination
of predisposition to cardiac hypertrophy, heart disease and heart failure.
2.5 LICENSED PRODUCT means any compound, assay, method, reagent, technology,
product or service comprising LICENSED SUBJECT MATTER pursuant to this
AGREEMENT.
2.6 LICENSED SUBJECT MATTER means inventions, discoveries, assays and processes
covered by PATENT RIGHTS and/or TECHNOLOGY RIGHTS within LICENSED FIELD.
2.7 NET SALES means the gross revenues received by LICENSEE, AFFILIATE,
NON-SUBLICENSEE CORPORATE PARTNER (as defined below) and/or any sublicensee from
the SALE of LICENSED PRODUCTS and/or IDENTIFIED PRODUCTS, 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 income tax) levied on the sale,
transportation or delivery of a LICENSED PRODUCT and/or IDENTIFIED PRODUCT; (iv)
payments or rebates paid in connection with sales of LICENSED PRODUCTS and/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 and/or IDENTIFIED PRODUCTS.
2.8 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 and/or IDENTIFIED PRODUCTS with such third
party, or to develop and/or commercialize LICENSED PRODUCTS and/or IDENTIFIED
PRODUCTS with such third party, and where such third party in not a sublicensee
as set forth in Section 4.4 under the terms of this AGREEMENT.
2.9 NON-SUBLICENSEE CORPORATE PARTNERSHIP REVENUES means any and all revenues
received by LICENSEE from a NON-SUBLICENSEE CORPORATE PARTNER as consideration
for rights granted by LICENSEE under agreements with NON-SUBLICENSEE CORPORATE
PARTNERS as set forth in Section 4.5 hereunder; provided however such revenues
exclude sums received: (i) for the purchase of an equity interest in LICENSEE;
(ii) for research and development work performed by or for LICENSEE; (iii) for
purchase of a supply of LICENSED PRODUCT and/or IDENTIFIED PRODUCT; (iv) for
repayment of any loans, credit or credit line extended by LICENSEE to a
NON-SUBLICENSEE CORPORATE PARTNER; (v) in the form of a loan, as credit or
pursuant to a credit line to LICENSEE; (vi) as royalties; and (vii) for
milestones achieved during the development of LICENSED PRODUCTS and/or
IDENTIFIED PRODUCTS.
2.10 PATENT RIGHTS means BOARD'S rights in information or discoveries covered by
a VALID CLAIM (as defined below) in patents, and/or patent applications, whether
domestic or foreign, and all divisionals, continuations, continuations-in-part,
reissues, reexaminations or extensions thereof, and any letters patent that
issue thereon, as: (i) set forth in Exhibit 1 attached hereto; or (ii)
discovered, conceived and/or reduced to practice during the term of and directly
resulting from the research performed under the .
2.11 SALE, SELL OR SOLD means the transfer or disposition of a LICENSED PRODUCT
and/or IDENTIFIED PRODUCT for value to a party other than LICENSEE, excluding
any transfer or disposition to an AFFILIATE, NON-SUBLICENSEE CORPORATE PARTNER,
or sublicensee unless such AFFILIATE, NON-SUBLICENSEE CORPORATE PARTNER, or
sublicensee is an end user. SALE shall not mean transfer of LICENSED PRODUCT
and/or IDENTIFIED PRODUCT, at or below cost, for research, development or
clinical trial purposes.
2.12 SUBLICENSEE REVENUES means any and all revenues received by LICENSEE in
consideration for the grant of a sublicense as set forth in Section 4.4
hereunder; provided, however such revenues exclude sums received: (i) for the
purchase of an equity interest in LICENSEE; (ii) for research and development
work performed by or for LICENSEE; (iii) for purchase of a supply of LICENSED
PRODUCT and/or IDENTIFIED PRODUCT; (iv) for repayment of any loans, credit or
credit line extended by LICENSEE to a sublicensee; (v) in the form of a loan, as
credit or pursuant to a credit line to LICENSEE; (vi) as royalties; and (vi) for
milestones achieved during the development of LICENSED PRODUCTS and/or
IDENTIFIED PRODUCTS.
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2.13 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(S) at UT
SOUTHWESTERN before or during the term of the
relating to the LICENSED SUBJECT MATTER that are not covered by PATENT RIGHTS
but that are necessary or useful for practicing the invention(s) covered by
PATENT RIGHTS and are not obligated to any other third party.
2.14 THIRD PARTY means any person or entity other than LICENSEE, its AFFILIATES,
NON-SUBLICENSEE CORPORATE PARTNERS or sublicensees.
2.15 VALID CLAIM means a claim or claims of. (i) an issued, unexpired patent,
whether domestic or foreign, so long as any such claim shall not have been held
invalid or unenforceable in an unappealed or an unappealable decision, in a
court of competent jurisdiction; or (ii) a pending patent application, whether
foreign or domestic, 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 of
America (GOVERNMENT), as set forth below, BOARD represents and warrants (1) that
it is the owner of the entire right, title, and interest in and to LICENSED
SUBJECT MATTER, (2) that it has the sole right to grant licenses thereunder, and
(3) that to the best of its knowledge 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 and, if so, that the
GOVERNMENT may have certain rights relative thereto. This AGREEMENT is
explicitly made subject to the GOVERNMENT's rights under any agreement and any
applicable law or regulation. If there is a conflict between any agreement,
applicable law or regulation and this AGREEMENT, the terms of the GOVERNMENT
agreement, applicable law or regulation shall prevail.
3.3 LICENSEE understands and acknowledges that BOARD, by this AGREEMENT, makes
no representation as to the operability or fitness for any use, safety,
efficacy, approvability by regulatory authorities, time and cost of development,
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 which may be dominant or
subordinate to PATENT RIGHTS, 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
(1) it has had sufficient
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*#* CONFIDENTIAL TREATMENT REQUESTED
opportunity to conduct due diligence with respect to all items and issues
pertaining to the LICENSED SUBJECT MATTER; and (2) LICENSEE 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, worldwide, 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 for use within LICENSED FIELD. This grant is subject to the payment by
LICENSEE to BOARD of all consideration as provided herein, and is further
subject to rights retained by BOARD to:
a. publish the general scientific findings from research related to
LICENSED SUBJECT MATTER and IDENTIFIED PRODUCTS subject to the terms of
Article 13, Confidential Information, provided however, INVENTOR shall
disclose pending publications to LICENSEE in accordance with Section
6.1 of the ; and
b. use LICENSED SUBJECT MATTER and IDENTIFIED PRODUCTS for research
that has not been sponsored by a commercial entity, teaching and other
educationally-related purposes, provided, however, that any such use
with respect to IDENTIFIED PRODUCTS shall be limited to IDENTIFIED
PRODUCTS which are either (1) owned by BOARD, or (2) provided to BOARD
by an authorized party. Any transfer of material embodiments of
LICENSED SUBJECT MATTER pursuant to this Section 4.1b shall be governed
by a material transfer agreement substantially in the form attached
hereto as Exhibit 3.
4.2 LICENSEE cannot use LICENSED SUBJECT MATTER for the development or
identification of IDENTIFIED PRODUCTS in any way for the benefit of any THIRD
PARTY. Additionally, LICENSEE cannot transfer to any THIRD PARTY information
resulting from the use of LICENSED SUBJECT MATTER with compounds not owned by or
licensed to LICENSEE.
4.3 LICENSEE may extend the license granted herein to any AFFILIATE if the
AFFILIATE consents in writing to be bound by this AGREEMENT to the same extent
as LICENSEE. LICENSEE must deliver to BOARD a true and accurate copy of such
written agreement, and any modification or termination thereof, within 30 days
after execution, modification or termination.
4.4 LICENSEE may grant sublicenses consistent with this AGREEMENT if LICENSEE is
responsible for the operations of its sublicensees relevant to this AGREEMENT as
if the operations were carried out by LICENSEE, including the payment
obligations set forth in Article 5 whether or not paid to LICENSEE by a
sublicensee. LICENSEE must deliver to BOARD a true and correct copy of each
sublicense granted by LICENSEE, and any modification or termination thereof,
within 30 days after execution, modification, or termination. When this
AGREEMENT is terminated, BOARD and UT SOUTHWESTERN agree to accept as successors
to LICENSEE existing sublicensees in good standing at the date of termination,
provided that the sublicensees consent in writing to be bound by all the terms
and conditions of this AGREEMENT.
4.5 LICENSEE may enter into agreements with NON-SUBLICENSEE CORPORATE PARTNERS
consistent with this AGREEMENT if LICENSEE is responsible for the operations of
its NON-SUBLICENSEE CORPORATE PARTNERS relevant to this AGREEMENT as if
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*#* CONFIDENTIAL TREATMENT REQUESTED
the operations were carried out by LICENSEE including the payment obligations
set forth in Article 5 whether or not paid to LICENSEE by a NON-SUBLICENSEE
CORPORATE PARTNER. LICENSEE must deliver to BOARD a true and correct copy of
each NON-SUBLICENSEE CORPORATE PARTNER agreement granted by LICENSEE, and any
modification or termination thereof, within 30 days after execution,
modification, or termination thereof (which copy may be redacted to delete
information not relevant to determining whether LICENSEE and/or NON-SUBLICENSEE
CORPORATE PARTNER have complied with their obligations to BOARD hereunder). When
this AGREEMENT is terminated, NON-SUBLICENSEE CORPORATE PARTNER rights relevant
to this AGREEMENT will also terminate, subject to the obligations that survive
termination pursuant to Article 7.
5. PAYMENTS AND REPORTS
5.1 In consideration of rights granted by BOARD to LICENSEE under this
AGREEMENT, LICENSEE will pay BOARD the following:
a. [*#*] license documentation fee in the amount of [*#*], due and
payable within 30 days of LICENSEE'S receipt of a fully executed
AGREEMENT from BOARD;
b. an annual license reissue fee in the amount of [*#*], due and
payable within 30 days of each anniversary of the EFFECTIVE DATE
beginning on [*#*];
c. milestone fees according to the table below, due and payable within
30 days of each milestone event for the first LICENSED PRODUCT or
IDENTIFIED PRODUCT to achieve such milestone event, [*#*], provided
however, if LICENSEE pays a milestone fee under the 1999 AGREEMENT for
a milestone event listed below, such payment is creditable toward the
milestone fee due for the same milestone event for the same LICENSED
PRODUCT or IDENTIFIED PRODUCT pursuant to this Section 5.1c:
MILESTONE EVENT MILESTONE FEE
--------------- -------------
The date the first patient is dosed in the first [*#*]
Phase III clinical trial
Filing of the first new drug application [*#*]
d. a running royalty equal to [*#*] of NET SALES [*#*], subject to
adjustment under Sections 5.1e and 5.1f below;
e. if LICENSEE is required to pay royalties to a third party under
patents owned by such third party to use, manufacture, have
manufactured, offer for SALE, SELL or import LICENSED PRODUCTS or
IDENTIFIED PRODUCTS, then LICENSEE may reduce the royalty payment owed
to BOARD on the same LICENSED PRODUCT or IDENTIFIED PRODUCT under
Section 5.1d by an amount equal to [*#*], but in no event shall such
reduction result in a royalty of less than [*#*] of the royalties due
pursuant to Section 5.1d;
f. if LICENSEE is required to pay royalties on a LICENSED PRODUCT or
IDENTIFIED PRODUCT under the 1999 AGREEMENT then LICENSEE may reduce
the royalty payment owed to BOARD on the same LICENSED PRODUCT or
IDENTIFIED PRODUCT under Section 5.1d by an amount equal to [*#*];
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g. [*#*] for all out-of-pocket expenses paid by UT SOUTHWESTERN prior
to [*#*] in filing, prosecuting, enforcing and maintaining PATENT
RIGHTS, and all such expenses paid by UT SOUTHWESTERN on or after
[*#*]. UT SOUTHWESTERN will invoice LICENSEE within 60 days of the
EFFECTIVE DATE and on a quarterly basis thereafter. The invoiced
amounts will be due and payable by LICENSEE within 30 days;
h. a sublicense fee of [*#*] of SUBLICENSEE REVENUES and/or
NON-SUBLICENSEE CORPORATE PARTNERSHIP REVENUES, subject to adjustment
under Section 5.1i below, payable within 30 days of LICENSEE'S receipt
of any such consideration; and
i. if LICENSEE is required to pay a fee pursuant to Section 5.1(f) of
the 1999 AGREEMENT, then LICENSEE may reduce the sublicensee fee owed
to BOARD on the same SUBLICENSEE REVENUES or the same NON-SUBLICENSEE
CORPORATE PARTNERSHIP REVENUES under Section 5.1h above by an amount
[*#*].
5.2 During the term of this AGREEMENT and for 1 year thereafter, LICENSEE agrees
to keep sufficiently complete and accurate records of its and its sublicensees'
SALES and NET SALES under the license granted in this AGREEMENT to enable the
royalties payable hereunder to be determined. LICENSEE agrees to permit BOARD or
its representatives, at BOARD'S expense and with 14 days written notice, to
periodically examine such records during regular business hours for the purpose
of and to the extent necessary to verify any report required under this
AGREEMENT, provided that such examination occurs not more frequently than 2
times per year. [*#*]
5.3 Within 30 days after March 31, June 30, September 30, and December 31 of
each year of the valid term of this AGREEMENT, beginning after the first to
occur of: (i) LICENSEE'S receipt of SUBLICENSEE REVENUES; (ii) LICENSEE'S
receipt of NON-SUBLICENSEE CORPORATE PARTNERSHIP REVENUES; or (iii) first SALE
of a LICENSED PRODUCT or IDENTIFIED PRODUCT, LICENSEE must deliver to BOARD a
true and accurate written report, even if no payments are due BOARD, giving the
particulars of the business conducted by LICENSEE and its sublicensee(s) and
NON-SUBLICENSEE CORPORATE PARTNERS, if any exist, during the preceding 3
calendar months under this AGREEMENT as are pertinent to calculating payments
hereunder. This report will include at least:
a. the total quantities of LICENSED PRODUCTS and/or IDENTIFIED
PRODUCTS produced; and
b. the total SALES by country, product, quantity and extended
dollars SOLD, and the conversion factor used to convert to
United States dollars; and
c. the calculation of royalties thereon; and
d. the total royalties computed and due BOARD; and
e. all other amount due BOARD herein.
Simultaneously with the delivery of each report, LICENSEE must pay to BOARD the
amount, if any, due for the period of each report. Such reports and records are
to be treated as LICENSEE'S Confidential Information and therefore subject to
the obligations set forth in Article 13.
5.4 On or before each anniversary of the EFFECTIVE DATE, irrespective of having
a first SALE or offer for SALE, LICENSEE must deliver to BOARD a written
progress report as to LICENSEE'S (and any sublicensee's) efforts and
accomplishments during the preceding year in commercializing LICENSED SUBJECT
MATTER and LICENSEE'S (and sublicensee's and
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NON-SUBLICENSEE CORPORATE PARTNER'S) commercialization plans for the upcoming
year.
5.5 [*#*] Check must be payable to UT SOUTHWESTERN and sent to:
UT Southwestern Medical Center at Dallas
Office for Technology Development
0000 Xxxxx Xxxxx Xxxxxxxxx
Xxxxxx, Xxxxx 00000-0000
ATTN: Director for Technology Development
6. SPONSORED RESEARCH
LICENSEE and UT SOUTHWESTERN have entered into, concurrently with this
AGREEMENT, a in the form attached hereto as Exhibit
2.
7. TERM AND TERMINATION
7.1 The term of this AGREEMENT is from the EFFECTIVE DATE and continues on a
country-by-country and product-by-product basis for:
a. LICENSED PRODUCTS to the full end of the term or terms for which
PATENT RIGHTS have not expired; and
b. IDENTIFIED PRODUCTS until 15 years after the date of the first
commercial SALE of such IDENTIFIED PRODUCT in such country.
7.2 Any time after 4 years from the, EFFECTIVE DATE, BOARD and UT SOUTHWESTERN
have the right to terminate this license in any national political jurisdiction
if LICENSEE, within 90 days after receiving written notice from UT SOUTHWESTERN
of the intended termination, fails to provide written evidence satisfactory to
UT SOUTHWESTERN that LICENSEE or its sublicensee(s) has commercialized or is
actively attempting to commercialize a licensed invention in such
jurisdiction(s). The following definitions apply to Article 7: (1)
"commercialize" means having SALES or LICENSED PRODUCTS or IDENTIFIED PRODUCTS
in such jurisdiction; (2) "attempting to commercialize" means having SALES of
LICENSED PRODUCTS or IDENTIFIED PRODUCTS, or an ongoing and active research,
development, manufacturing, marketing or sales program as appropriate, directed
toward obtaining regulatory approval, and/or production and/or SALES of LICENSED
PRODUCTS or IDENTIFIED PRODUCTS in any jurisdiction, and has provided UT
SOUTHWESTERN with a copy of its plans to commercialize licensed inventions in
the jurisdiction(s) that UT SOUTHWESTERN intends to terminate. Such
commercialization plans are to be treated as LICENSEE'S Confidential Information
and therefore subject to the obligations set forth in Article 13.
7.3 This AGREEMENT will earlier terminate:
a. 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
b. upon 60 days written notice from BOARD if LICENSEE breaches or
defaults on its obligation to make payments (if any are due) or
reports, in accordance with the terms
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of Article 5 hereunder, 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
c. upon 90 days written notice if LICENSEE 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
d. at any time by mutual written agreement between LICENSEE, UT
SOUTHWESTERN and BOARD, upon 30 days written notice to all parties and
subject to any terms herein which survive termination; or
e. under the provisions of Section 7.2 if invoked.
7.4 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;
b. after the effective date of the termination, LICENSEE will provide
BOARD with a written inventory of all LICENSED PRODUCTS and/or
IDENTIFIED PRODUCTS in process of manufacture, in use or in stock.
LICENSEE may SELL any such LICENSED PRODUCTS and/or IDENTIFIED PRODUCTS
[*#*]
c. LICENSEE will be bound by the provisions of Articles 11
(Indemnification), 12 (Use of Name), and 13 (Confidential Information)
of this AGREEMENT.
8. INFRINGEMENT BY THIRD PARTIES
8.1 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 knowledge thereof, then BOARD may enforce
any patent licensed hereunder on behalf of itself and LICENSEE, [*#*]. LICENSEE
and BOARD shall each provide the other prompt written notice of alleged
infringement by any third party of the PATENT RIGHTS.
8.2 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.
9. ASSIGNMENT
Except in connection with the sale of substantially all of LICENSEE'S assets or
outstanding capital stock (including by merger, reorganization or
recapitalization) to a third party, this
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AGREEMENT may not be assigned by LICENSEE without the prior written consent of
BOARD, which will not be unreasonably withheld.
10. PATENT MARKING
LICENSEE must permanently and legibly xxxx all products, packaging and
documentation manufactured or SOLD by it under this AGREEMENT with a patent
notice as may be permitted or required under Xxxxx 00, Xxxxxx Xxxxxx Code.
11. 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.
12. USE OF NAME
LICENSEE may not use the name of UT SOUTHWESTERN, SYSTEM, INVENTOR(S) or BOARD
without express written consent from UT SOUTHWESTERN and/or SYSTEM, except as
required by law, rule or regulation.
13. CONFIDENTIAL INFORMATION
13.1 BOARD and LICENSEE each agree that the terms and conditions contained in
this AGREEMENT and all information contained in documents marked "confidential"
and forwarded to one by the other for the purposes of this AGREEMENT
("Confidential Information") are: (1) to be received in strict confidence, (2)
to be used only for the purposes of this AGREEMENT, and (3) 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:
a. was in the public domain at the time of disclosure;
b. later became part of the public domain through no act or omission of
the recipient party, its employees, agents, successors or assigns;
c. was lawfully disclosed to the recipient party by a third party
having the right to disclose it;
d. was already known by the recipient party at the time of disclosure;
e. was independently developed by the recipient; or
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f. is required by law or regulation to be disclosed, provided however,
that the disclosing party shall first give the other party written
notice and adequate opportunity to object to such order for disclosure
or to request confidential treatment.
13.2 Information shall not be deemed to be available to the public or to be in
the recipient's possession merely because it:
a. includes information that falls within an area of general knowledge
available to the public or to the recipient (i.e., it does not include
the specific information provided by the other party); or
b. can be reconstructed in hindsight from a combination of information
from multiple sources that are available to the public or to the
recipient, unless one of those sources actually teaches or suggests the
entire combination, together with its meaning and importance.
13.3 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 disclosure of the
other party's Confidential Information it will, except where impracticable for
necessary disclosures, give reasonable advance notice to the other party of such
disclosure, requirement and, except to the extent inappropriate in the case of
patent applications, will use reasonable diligent efforts to secure confidential
treatment of such Confidential Information required to be disclosed. In
addition, LICENSEE may disclose the terms and conditions of this AGREEMENT to
its potential and current investors or to any entity that may potentially
acquire rights or licenses from LICENSEE provided such party agrees to the
confidentiality provisions in this Article 13.
13.4 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.
14. PATENTS AND INVENTIONS
14.1 BOARD and UT SOUTHWESTERN will select the patent attorney, patent agent
and/or law firm responsible for searching, filing, prosecuting and maintaining
patent applications and patents for LICENSED SUBJECT MATTER, such attorney,
agent and/or law firm to be reasonably acceptable to LICENSEE.
14.2 If after consultation, both parties agree that a patent application should
be filed for LICENSED SUBJECT MATTER, BOARD will authorize the preparation and
filing of the appropriate patent applications and such applications will be
included under PATENT RIGHTS (the parties agree to timely amend Exhibit 1 in
writing when new matter is added under
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*#* CONFIDENTIAL TREATMENT REQUESTED
PATENT RIGHTS). If LICENSEE does not respond or make an effort to agree with
BOARD on the disposition of rights in the subject invention, then BOARD may file
an application [*#*].
14.3 LICENSEE will directly pay all costs for searching, filing, prosecuting and
maintaining PATENT RIGHTS that accrue after the EFFECTIVE DATE, provided that UT
SOUTHWESTERN cooperates in the preparation of patent applications and in the
filing, prosecution and maintenance of PATENT RIGHTS. LICENSEE will provide UT
SOUTHWESTERN with evidence of payment of such costs within 30 days of LICENSEE'S
receipt of invoices. LICENSEE will notify UT SOUTHWESTERN if it does not intend
to pay any such costs at least 90 days prior to the deadline for such payment.
If LICENSEE (1) notifies BOARD that it does not intend to pay costs associated
with any patent application and/or patent under PATENT RIGHTS; or (2) fails to
pay costs in a timely manner, then LICENSEE will have no further rights under
this AGREEMENT to such patent application and/or patent.
14.4 LICENSEE will arrange to provide UT SOUTHWESTERN a copy of all patent
applications filed for LICENSED SUBJECT MATTER [*#*] as well as copies of any
patent related communications, including, but not limited to, office actions,
responses and invoices. The parties each have the right to review and comment
upon the wording of specifications, claims and responses to office actions prior
to their submission to the appropriate patent office.
15. GENERAL
15.1 This AGREEMENT constitutes the entire and only agreement between the
parties for LICENSED SUBJECT MATTER and all other prior negotiations,
representations, agreements, and understandings are superseded hereby. No
agreements altering or supplementing the terms hereof may be made except by a
written document signed by both parties.
15.2 Any notice required by this AGREEMENT must 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 and UT
SOUTHWESTERN to:
UT Southwestern
Xxx Xxxxxxxx
Director, Technology Development
0000 Xxxxx Xxxxx Xxxxxxxxx
Xxxxxx, Xxxxx 00000-0000
Phone: (000) 000-0000
Fax: (000) 000-0000
With copies to:
Board of Regents
The University of
Texas System
000 Xxxx 0xx Xxxxxx
Xxxxxx, Xxxxx 00000
ATTENTION: Office of General Counsel
Phone: (000) 000-0000
Fax: (000) 000-0000
or in the case of LICENSEE to:
J. Xxxxxxx Xxxxxxx
CEO and President
Myogen, Inc.
0000 X. 000xx Xxxxxx
Xxxxxxxxxxx, XX 00000-0000
Phone: (000) 000-0000
Fax: (000) 000-0000
or other addresses as may be given from time to time under the terms of this
notice provision.
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15.3 Each party must comply with all applicable national, state and local laws
and regulations in connection with its activities pursuant to this AGREEMENT.
15.4 This AGREEMENT will be construed and enforced in accordance with the laws
of the United States of America and of the State of
Texas.
15.5 Failure of either party to enforce a right under this AGREEMENT will not
act as a waiver of that right or the ability to later assert that right relative
to the particular situation involved.
15.6 Headings are included herein for convenience only and shall not be used to
construe this AGREEMENT.
15.7 If any part of this AGREEMENT is for any reason found to be unenforceable,
all other parts nevertheless remain enforceable.
15.8 Neither party shall be held liable or responsible to the other party nor be
deemed to have defaulted under or breached this AGREEMENT for failure or delay
in fulfilling or performing any term of this AGREEMENT when such failure or
delay is caused by or results from causes beyond the reasonable control of the
affected party, including, without limitation, fire, floods, earthquakes,
natural disasters, embargoes, war, acts of war (whether war be declared or not),
insurrections, riots, civil commotions, strikes, lockouts or other labor
disturbances, acts of God or acts, omissions or delays in acting by any
governmental authority or the other party.
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IN WITNESS WHEREOF, parties hereto have caused their duly authorized
representatives to. execute this AGREEMENT.
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 CEO and President
UT Southwestern Medical Center at Dallas
Date 12/27/01 Date 12/31/01
---------- ----------
Approved as to Content:
By /s/ Xxxxxx Xxxxx
---------------------------------------------
Xxxxxx X. Xxxxx, M.D.
Vice President for Technology Development
UT Southwestern Medical Center at Dallas
Date 27 December 2001
-----------------
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EXHIBIT 1
PATENT RIGHTS
[*#*]
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EXHIBIT 2
This (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") and MYOGEN,
Inc., a Delaware corporation with its principal place of business at 0000 Xxxx
000xx Xxxxxx, Xxxxx 000, Xxxxxxxxxxx, XX 00000 ("Sponsor").
RECITALS
A. Concurrently with this Agreement, Sponsor and Board have entered
into a license agreement effective January 1, 2002 (the "License Agreement"),
pursuant to which the Board grants Sponsor certain licenses under inventions,
discoveries and related intellectual property rights;
B. Sponsor desires that University perform certain research hereinafter
described and is willing to advance funds to sponsor such research;
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.
1. EFFECTIVE DATE
This Agreement shall be effective as of January 1, 2002 (the "Effective
Date").
2. RESEARCH PROGRAM
2.1 University will conduct the research program described in
Attachment A ("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. In the event
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 December 31, 2002 ("Term"). Sponsor shall
have the option to
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negotiate an extension of the Term under mutually agreeable support terms. Such
option shall be exercised within forty-five (45) days prior to the end of the
Term.
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 an amount
equal to [*#*]. An initial payment of [*#*] shall be made at the time of
execution of this Agreement, and subsequent payments shall be made [*#*].
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 the 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 on a reasonable
basis.
4.3 The Principal Investigator will make oral reports at reasonable
intervals each year as requested by Sponsor's Designated Representative. At the
conclusion of each calendar quarter, 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:
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a. A summary of expenses of the Research Program.
b. A report of the activities undertaken and accomplishments achieved
by the University under the Research Program.
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. Each party, however, shall have the right to acknowledge Sponsor's
support of the investigations under this Agreement in scientific or academic
publications and other scientific or academic communications, without the other
party'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 patentable information, University will submit any prepublication
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, 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.
[*#*] Neither University nor Principal Investigator shall disclose any such
materials for a period extending sixty (60) days from the date Sponsor provides
notice to University that it desires University to file such related patent
application. 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 discuss the
research being performed under this Agreement with other investigators but shall
not reveal information which is Sponsor's Confidential Information under Article
7. Neither University nor Principal Investigator shall involve any person in the
performance of the research being performed pursuant to this Agreement, other
than such persons as Sponsor agrees in writing may be so involved. In the event
any joint inventions result from such discussions, University shall grant to
Sponsor the rights outlined in Article 8 of this Agreement, to the extent these
are not in conflict with obligations to another party as a result of the
involvement of the other investigator(s). In this latter case, University shall,
in good faith, exercise reasonable efforts to apportion the rights to any such
joint invention between Sponsor and the investigator's third party sponsors in a
reasonable and equitable manner.
7. CONFIDENTIAL INFORMATION
7.1 Subject to the terms of this Article 7, the parties may wish, from
time to time, in connection with work contemplated under this Agreement, to
disclose confidential information
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to each other. All information in the Research Program and all information
contained in documents marked "confidential" and forwarded to one party by the
other ("Confidential Information") are: (i) to be held in strict confidence;
(ii) to be used only for the performance of the Research Program; and (iii) not
to be disclosed by the recipient party, its agents or employees without the
prior written consent of the disclosing party. Each party will use reasonable
efforts to prevent the disclosure of any of the other party's Confidential
Information to third parties for a period of three (3) years from receipt
thereof, provided that the recipient party's obligation shall not apply to
information that:
(a) is not disclosed in writing or reduced to writing and so
marked with an appropriate confidentiality legend within
thirty (30) days of disclosure;
(b) is already in the recipient party's possession at the time of
disclosure thereof;
(c) is or later becomes part of the public domain through no fault
of the recipient party;
(d) is received from a third party having no obligations of
confidentiality to the disclosing party;
(e) is independently developed by the recipient party; 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 disclosure
of the other party's Confidential Information it will, except where
impracticable for necessary disclosures, give reasonable advance notice to the
other party to allow that party to assert whatever exclusions or exemptions may
be available to it under such law or regulation.
7.3 Each party's obligation with respect to Confidential Information
under this Article 7 shall be fulfilled using at least the same degree of care
with the other party's Confidential Information as it uses to protect its own
Confidential Information, and in no case less than reasonable care.
8. PATENTS, COPYRIGHTS, AND TECHNOLOGY RIGHTS
8.1 Title to all Intellectual Property Rights made by University
resulting from the research performed hereunder shall reside in University. Such
inventions and discoveries are and shall be licensed to Sponsor pursuant to the
terms set forth in the License Agreement.
8.2 As used in this Section 8, the term:
"Intellectual Property Rights" means, collectively, all trademark,
trade name, 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 Technology Rights; provided, however,
that subject to Section 6.2, it shall not
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include any intellectual or proprietary rights that are owned by or
contractually obligated to a third party;
"Technology Rights" has the meaning ascribed thereto in the License
Agreement; and
"Patent Rights" has the meaning ascribed thereto in the License
Agreement.
8.3 Prosecution, maintenance and enforcement of any and all
intellectual property rights related to inventions and discoveries made by
University resulting form the research performed under this Agreement 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 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 the obligations 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, that the following is excluded from Sponsor's obligation to
indemnify and hold harmless:
a. the failure of System, University or Principal Investigator to
comply with any applicable FDA or other governmental law,
regulation, or requirements;
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
proprietary 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
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 and the University and System shall grant Sponsor authority to
conduct such defense.
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.
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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 Article 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 funding of the Research Program and this Agreement: (a) upon thirty
(30) days notice if University is unable to find a suitable successor to Xx.
Xxxxx reasonably acceptable to Sponsor pursuant to Section 2.1; or (b) after the
end of the third calendar quarter of the first year of the Term, upon ninety
(90) days written notice (a "Termination Notice") to University asserting for
reasons stated, Sponsor deems that unsatisfactory progress by the Principal
Investigator is being made on the Research Program, provided that University has
the opportunity to cure such unsatisfactory progress within the Termination
Notice period.
11.3 In the event that either party shall be in default of its material
obligations under this Agreement and shall fail to remedy such default within
sixty (60) days after receipt of written notice thereof, this Agreement shall
terminate upon expiration of the sixty (60) day period.
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 for any termination by Sponsor
pursuant to Section 11.2(b) above, as its sole liability upon termination,
Sponsor shall pay University [*#*]
11.5 The obligations of the parties that are contained in Sections 5,
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 than those provided under 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 either party without the
prior written consent of the other party; provided, however, that subject to the
approval of University, which may not be unreasonably withheld, Sponsor may
assign this Agreement to any purchaser or transferee of all or substantially all
of Sponsor's assets or stock upon prior written notice to University, and
University may assign its right to receive payments hereunder.
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13.2 This Agreement constitutes the entire and only agreement 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 Any notice required by this Agreement by Articles 9, or 11 shall
be given by prepaid, first class, certified mail, return receipt requested,
addressed in the case of University to:
The University of Texas System, O.G.C.
000 Xxxx 0xx Xxxxxx
Xxxxxx, XX 00000
Attention: Intellectual Property Section
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: Xxxxx Xxxxxxxx
Director, Contracts Management
FAX: (000) 000-0000
PHONE: (000) 000-0000
or in the case of Sponsor to:
MYOGEN, INC.
0000 Xxxx 000xx Xxxxxx #000
Xxxxxxxxxxx, 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.
13.4 This Agreement shall be governed by, construed, and enforced in
accordance with the internal laws of the State of Texas.
13.5 Each party shall comply with all federal, state and local laws,
regulations and ordinances in connection with the activities it conducts under
this Agreement.
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IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed by their duly authorized representatives.
THE UNIVERSITY OF TEXAS SPONSOR
SOUTHWESTERN MEDICAL CENTER
AT DALLAS
/s/ Xxxxxx X. Xxxxxx /s/ J. Xxxxxxx Xxxxxxx
---------------------------------- ----------------------------------
Xxxxxx X. Xxxxxx, M.D. J. Xxxxxxx Xxxxxxx
Xxxx, Southwestern Medical School President and CEO
Date 1/10/02 Date 12-31-01
------------------------------ ------------------------------
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ATTACHMENT A
RESEARCH PROGRAM
[*#*]
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AMENDMENT NO. 1 TO
THIS AMENDMENT NO. 1 (the "Amendment") TO THE effective as of January 1, 2002, 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 amount
due to the University pursuant to Section 3.1 for the fourth calendar quarter of
2002; provided that payment of an amount equal to the total of such delayed
payment (twenty five thousand 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
1
EXHIBIT 3
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
"RECIPIENT", and The University of Texas Southwestern Medical Center at Dallas,
hereinafter "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 SCIENTIST in research to study
_______________________________________________ hereinafter "RESEARCH."
4. Neither SCIENTIST nor RECIPIENT shall distribute, release, or in any
way disclose the MATERIAL to any person or entity other than laboratory
personnel under SCIENTIST'S direct supervision, and SCIENTIST and RECIPIENT
shall ensure that no one will be allowed to take or send MATERIAL to any other
location, unless written permission is obtained from UT SOUTHWESTERN. [*#*]
5. RECIPIENT understands that the MATERIAL may be subject to certain
exclusive licensing arrangements between UT SOUTHWESTERN and Myogen, Inc.
(hereinafter "MYOGEN"). RECIPIENT agrees to use the MATERIAL solely for
research, teaching and other educationally-related, non-commercial purposes
only. [CHOOSE ONE OF THE FOLLOWING] [*#*]
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 commercially sponsored
research or 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.
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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
SOUTHWESTERN that might be disclosed by such publication. If the publication
comes about, 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,
including [*#*], 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.
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13. This AGREEMENT constitutes the entire and only agreement between
the parties for MATERIAL and all other prior representations, agreements, and
understandings are superseded hereby.
THE UNIVERSITY OF TEXAS RECIPIENT
SOUTHWESTERN MEDICAL CENTER
AT DALLAS
0000 Xxxxx Xxxxx Xxxxxxxxx Xxxxxxx
Xxxxxx, Xxxxx 00000 ---------------------------
----------------------------------
--------------------------------- ---------------------------------
Xxxxxx X. Xxxxxx Name:
Xxxx, Southwestern Medical School Title:
Date: Date:
---------------------------- ----------------------------
READ AND UNDERSTOOD
----------------------------------
SCIENTIST
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