PATENT AND TECHNOLOGY LICENSE AGREEMENT (as Amended)
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
EXHIBIT
10.3
(as
Amended)
THIS
AGREEMENT ("AGREEMENT") is made on this 14th day of February, 2000 between
the
BOARD OF REGENTS ("BOARD") of THE UNIVERSITY OF TEXAS SYSTEM ("SYSTEM"),
an
agency of the State of Texas, whose address is ▇▇▇ ▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇,
▇▇▇▇▇ ▇▇▇▇▇, on behalf of THE UNIVERSITY OF TEXAS M. D. ▇▇▇▇▇▇▇▇ CANCER CENTER
("MDA"), a component Institution of SYSTEM and INEX Pharmaceuticals Corp,
a
British Columbia corporation having a principal place of business located
at 100
- 8900 Glenlyon Parkway, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇, ▇▇▇▇▇▇ ▇▇▇
▇▇▇
("LICENSEE").
RECITALS
| A. |
BOARD
owns certain PATENT RIGHTS and TECHNOLOGY RIGHTS related to LICENSED
SUBJECT MATTER, which were jointly developed by LICENSEE and
MDA.
|
| B. |
BOARD
desires to have the LICENSED SUBJECT MATTER developed in the LICENSED
FIELD and used for the benefit of LICENSEE, BOARD, SYSTEM, MDA, the
inventor(s), and the public as outlined in BOARD'S Intellectual Property
Policy.
|
| C. |
LICENSEE
wishes to obtain an exclusive license from BOARD to its rights in
the
LICENSED SUBJECT MATTER,
|
NOW,
THEREFORE, in consideration of the mutual covenants and promises herein
contained, the parties agree as follows:
I. EFFECTIVE
DATE
|
1.1
|
This
AGREEMENT is effective as of the date written herein above ("EFFECTIVE
DATE") subject to approval of
BOARD.
|
II. DEFINITIONS
As
used
in this AGREEMENT, the following terms have the meanings indicated:
|
2.1
|
AFFILIATE
means any business entity at least 50% owned by LICENSEE, any business
entity which owns at least 50% of LICENSEE, or any business entity
that is
at least 50% owned by a business entity that owns at least 50%
of
LICENSEE.
|
|
2.2
|
LICENSED
FIELD means cancer therapy.
|
|
2.3
|
LICENSED
PRODUCTS means any product or service SOLD by LICENSEE or SUBLICENSEE
comprising LICENSED SUBJECT MATTER pursuant to this
AGREEMENT.
|
|
2.4
|
LICENSED
SUBJECT MATTER means inventions and discoveries covered by PATENT
RIGHTS
or TECHNOLOGY RIGHTS within licensed
Field.
|
|
2.5
|
LICENSED
TERRITORY means worldwide.
|
|
2.6
|
NET
SALES means the gross revenues received by LICENSEE or SUBLICENSEE
from
the SALE of LICENSED PRODUCTS less sales, discounts actually granted,
sales and/or use taxes actually paid, import and/or export duties
actually
paid, outbound transportation actually prepaid or allowed, and
amounts
actually allowed or credited due to returns (not exceeding the
original
billing or invoice amount).
|
|
2.7
|
PATENT
RIGHTS means BOARD'S rights in information or discoveries covered
in
patents, whether domestic or foreign, and all divisionals, continuations,
continuations-in-part, reissues, reexaminations or extensions thereof,
any
patent document claiming priority therefrom, and any letters patent
that
issue thereon as defined in Exhibit I attached
hereto.
|
|
2.8
|
SALE,
SELL or SOLD shall mean the transfer or disposition of a LICENSED
PRODUCT
for value to a party other than LICENSEE, SUBLICENSEE, or
AFFILIATE.
|
|
2.9
|
TECHNOLOGY
RIGHTS shall mean BOARD'S rights in any technical information,
know-how,
processes, procedures, compositions, devices, methods, formulae,
protocols, techniques, software, designs, drawings or data created
by the
inventor(s) listed in Exhibit I at MDA before the Effective Date
relating
to the use of liposomal vinca alkaloids which are not covered by
PATENT
RIGHTS but which are necessary for practicing the inventions covered
PATENT RIGHTS.
|
III. LICENSE
|
3.1
|
BOARD,
through MDA, hereby grants to LICENSEE a royalty-bearing, exclusive
license under LICENSED SUBJECT MATTER to manufacture, have manufactured,
use and/or SELL LICENSED PRODUCTS within LICENSED TERRITORY for
use within
LICENSED FIELD and, subject to Paragraph 4.7 herein, will extend
to
BOARD's undivided interest in any LICENSED SUBJECT MATTER developed
during
the term of this AGREEMENT and jointly owned by BOARD and LICENSEE.
This
grant shall be subject to Paragraph 14.2 and 14.3 hereinbelow,
the payment
by LICENSEE to BOARD of all consideration as provided herein, the
timely
payment of all amounts due under any Sponsored Research Agreement
between
MDA and LICENSEE in effect during this AGREEMENT and is further
subject to
the following rights retained by BOARD and MDA
to:
|
|
(a)
|
Publish
the general scientific findings from research related to LICENSED
SUBJECT
MATTER and
|
|
(b)
|
Use
LICENSED SUBJECT MATTER for educationally-related research, teaching,
patient care, and other purposes.
|
Both
subsections (a) and (b) above are subject to the terms of Article XI -
Confidential Information and Publication.
|
3.2
|
LICENSEE
may extend the license granted herein to any AFFILIATE provided
that the
AFFILIATE consents in writing to be bound by this AGREEMENT to
the same
extent as LICENSEE.
|
|
3.3
|
Subject
to the Paragraph 3.4 herein below, LICENSEE may grant sublicenses
under
LICENSED SUBJECT MATTER consistent with the terms of this AGREEMENT
provided that LICENSEE is responsible for its sublicensees relevant
to
this AGREEMENT, and for diligently collecting all amounts
due LICENSEE from sublicensees. If a sublicensee pursuant hereto
becomes
bankrupt, insolvent or is placed in the hands of a receiver or
trustee,
LICENSEE, to the extent allowed under applicable law and in a timely
manner, agrees to use its best reasonable efforts to collect all
consideration owed to LICENSEE and to have the sublicense agreement
confirmed or rejected by a court of proper
jurisdiction.
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
|
3.4
|
LICENSEE
must deliver to NIDA 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.
|
|
3.5
|
When
this AGREEMENT is terminated, BOARD and MDA agree to accept as
successors
to LICENSEE, existing sublicensees in good standing at the date
of
termination provided that such sublicensees consent in writing
to be bound
by all of the terms and conditions of this
AGREEMENT.
|
IV. CONSIDERATION,
PAYMENTS AND REPORTS
|
4.1
|
In
consideration of rights granted by BOARD to LICENSEE under this
AGREEMENT,
LICENSEE agrees to pay MDA the
following:
|
|
(a)
|
LICENSEE
has been and continues to pay for expenses for future patent issues
in
filing, prosecuting, enforcing and maintaining PATENT RIGHTS, and
all
future expenses will be paid by LICENSEE, for so long as, and in
such
countries as, this AGREEMENT remains in effect. MDA maintains the
option
to file, prosecute, enforce and maintain patent rights in jurisdictions
where LICENSEE elects to avoid patent
prosecution.
|
|
(b)
|
non-refundable
license documentation fee in the amount of $[***]. This fee will
not
reduce the amount of any other payment provided for in this ARTICLE
IV,
and is due and payable within 30 days after the AGREEMENT has been
fully
executed by all parties and LICENSEE has received an invoice for
the
amount from MDA;
|
|
(c)
|
A
non-refundable annual minimum license fee payable on each anniversary
of
the Effective Date of US $[***] prior to patent issue, and a
non-refundable annual minimum fee of US $[***] if a patent has
issued as
of said anniversary date. This annual minimum fee will be invoiced
by MDA
and payable by LICENSEE 30 days from receipt of
invoice.
|
|
(d)
|
A
running royalty equal to the:
|
|
1)
|
"Issued
Patent" royalty designated below on the applicable portion of NET
SALES of
LICENSED PRODUCTS in national political jurisdictions in the LICENSED
TERRITORY where LICENSED SUBJECT MATTER is covered by 1 or more
issued
patent(s) or granted/registered
patent
|
|
2)
|
and
a running royalty equal to the "Non-issued Patent" royalty designated
below on the applicable portion of NET SALES of LICENSED PRODUCTS
where
LICENSED SUBJECT MATTER is covered by one or more pending patent
applications but no issued or granted/registered patent as
follows:
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
ROYALTY
SCHEDULE
|
Royalty
is applied to each portion of Net Sales as follows:
US
$
|
|||
|
$[***]
- $[***]
|
$[***]
- $[***]
|
$[***]+
|
|
|
Issued
Patent
|
[***]%
|
[***]%
|
[***]%
|
|
Royalty
is applied to each portion of Net Sales as follows:
US
$
|
|||
|
Non-Issued
Patent
|
[***]%
|
[***]%
|
[***]%
|
In
the event LICENSEE elected to forego patent prosecution in any given national
political jurisdiction, MDA may at its option elect to pay for and maintain
the
patent in said jurisdiction. In the absence of any other agreement between
the
parties about said jurisdiction, if Licensee has Sales in said jurisdiction,
then LICENSEE will reimburse MDA all patent expenses, 30 days after receipt
of
invoice and, in addition, LICENSEE will pay to MDA the royalty identified
in the
schedule above and an additional [***]% on Net Sales in each such jurisdiction
if the patent claims cover the Licensed Subject Matter.
|
(e)
|
Annual
minimum fees paid prior to Sales will not be credited against future
royalty payments. Any annual minimum fees made in any given year
of Sales
will be credited against that year's royalty
due.
|
4.2 Other
Considerations:
(a) The
calculation of said response rate will include all clinical sites, OTHER
THAN
MDA, who employ the ▇▇▇▇▇▇ dosing schedule and patient exclusion criteria.
Phase
II/III data generated by MDA may be used by INEX as identified in a Sponsored
Research Agreement, and only excluded from calculation of this milestone
payment.
(b) INEX
will
work with Drs. ▇▇▇▇▇▇▇▇▇▇ and ▇▇▇▇▇▇ to identify opportunities for additional
sponsored research programs.
|
4.3
|
All
such payments are payable within 30 days after March 31, June 30,
September 30, and December 31 of each year during the term of this
AGREEMENT, at which time LICENSEE will also deliver to BOARD and
MDA a
true and accurate report, giving such particulars of the business
conducted by LICENSEE and its sublicensees, if any exist, during
the
preceding three (3) calendar months under this AGREEMENT as necessary
for
BOARD to account for LICENSEES's payments hereunder. This report
will
include pertinent data, including, but not limited
to:
|
(a) the
total
quantities of LICENSED PRODUCTS produced;
(b) the
total
SALES
(c) the
calculation of royalties thereon
(d) the
total
royalties or minimum
royalties
so
computed and due MDA; and all other amounts due MDA herein.
|
4.4
|
During
the Term of this AGREEMENT and for 1 year thereafter, LICENSEE
agrees to
keep complete and accurate records of its and its sublicensees'
SALES and
NET SALES of LICENSED
PRODUCTS in sufficient detail to enable the royalties payable hereunder
to
be determined. LICENSEE agrees to permit MDA or its representatives,
at
MDA's expense, to periodically, but not more than once per calendar
year,
examine its books, ledgers, and records during regular business
hours for
the purpose of and to the extent necessary to verify any report
required
under this AGREEMENT. If the amounts due MDA are determined to
have been
underpaid in an amount equal to or greater than [***]% of the total
amount
due during the period of time so examined, then LICENSEE will pay
the cost
of the examination plus the accrued interest at the highest allowable
rate.
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
|
4.5
|
Upon
the request of MDA, but not more than one time per calendar year,
LICENSEE
will deliver to MDA a written progress report as to LICENSEE'S
(and
sublicensees') efforts and accomplishments during the preceding
year in
diligently commercializing LICENSED SUBJECT MATTER in the LICENSED
TERRITORY and LICENSEE'S (and sublicensees') commercialization
plans for
the upcoming year. This report is not to be construed as a performance
obligation.
|
|
4.6
|
All
amounts payable hereunder by LICENSEE shall be payable in United
States
funds without deductions for taxes, assessments, fees, or charges
of any
kind. Checks are to be made payable to The University of Texas
M. D.
▇▇▇▇▇▇▇▇ Cancer Center, Box 297402, ▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇, Attention:
Manager, Grants and Contracts Accounting and mailed by U.S.
mail.
|
|
4.7
|
No
payments due or royalty rates owed under this AGREEMENT will be
reduced as
the result of co-ownership of LICENSED SUBJECT MATTER by BOARD
and another
party, including, but not limited to
LICENSEE.
|
V. SPONSORED
RESEARCH
|
5.1
|
If
LICENSEE desires to sponsor research for or related to the LICENSED
SUBJECT MATTER, and particularly where LICENSEE receives payments
for
sponsored research pursuant to a sublicense under this AGREEMENT,
LICENSEE
will give good faith consideration to funding the proposals at
MDA.
|
VI. PATENTS
AND INVENTIONS
|
6.1
|
If
after consultation with LICENSEE, both parties agree that a patent
application should be filed for LICENSED SUBJECT MATTER, BOARD
or LICENSEE
will prepare and file the appropriate patent applications, and
LICENSEE
will pay the cost of searching, preparing, filing, prosecuting
and
maintaining same. If LICENSEE notifies MDA that it does not intend
to pay
the cost of a patent application or the prosecution or maintenance
thereof
in a national political jurisdiction, then MDA may file, prosecute
or
maintain such application, at its own expense, and LICENSEE will
have no
further rights to such patent application or patent unless LICENSEE
is a
co-inventor of such, in which case right to practice the invention
shall
be governed by US Patent Law rules. LICENSEE will provide MDA a
copy of
the application for which LICENSEE has paid the cost of filing,
as well as
copies of any documents received or filed during prosecution
thereof.
|
VII. INFRINGEMENT
BY THIRD PARTIES
|
7.1
|
LICENSEE,
at its expense, has the right to enforce any patent exclusively
licensed
hereunder against infringement by third parties and is entitled
to retain
recovery from such enforcement. LICENSEE agrees to pay MDA a royalty
on
any monetary recovery after recovery of litigation or settlement
expenses,
if the monetary recovery is for damages or a reasonable royalty
in lieu
thereof. If LICENSEE does not file suit against a substantial infringer
within 6 months of knowledge thereof, then BOARD and MDA may, at
their
sole discretion, enforce any patent licensed hereunder on behalf
of itself
and LICENSEE, with MDA retaining all recoveries from such enforcement,
and/or reducing the license granted hereunder to
non-exclusive.
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
|
7.2
|
In
any suit or dispute involving an infringer, 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, and the like,
during
regular business hours.
|
VIII. PATENT
MARKING
|
8.1
|
LICENSEE
agrees that all packaging containing individual LICENSED PRODUCT(S),
and
documentation therefore, SOLD by LICENSEE, AFFILIATES, and/or sublicensees
of LICENSEE will be permanently and legibly marked with the number
of the
applicable patent(s) licensed hereunder in accordance with each
country's
patent laws, including ▇▇▇▇▇ ▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇
Code.
|
IX. INDEMNIFICATION
|
9.1
|
LICENSEE
agrees to hold harmless and indemnify BOARD, SYSTEM, MDA, its Regents,
officers, employees, students, and agents (collectively the "INDEMNITEES")
from and against any claims, demands, or causes of action whatsoever,
costs of suit and reasonable attorney's fees, including without
limitation, those costs 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, officers, its AFFILIATES or their officers, employees,
agents or
representatives except in the event of gross negligence on the
part of any
of the INDEMNITEES. This provision does not apply to any action
or
omission of any of the INDEMNITEES which is subject to another
agreement
between the parties or their agents, such as a sponsored research
agreement or a clinical trial
agreement.
|
X. USE
OF BOARD AND COMPONENT'S NAME
|
10.1
|
LICENSEE
will not use the name of (or the name of any employee of) MDA,
SYSTEM or
BOARD without the advance express written consent of BOARD secured
through:
|
The
University of Texas
M.
D.
▇▇▇▇▇▇▇▇ Cancer Center
Office
of
Public Affairs
▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇
▇▇▇▇▇▇▇,
▇▇▇▇▇ ▇▇▇▇▇
ATTENTION:
▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
XI. CONFIDENTIAL
INFORMATION AND PUBLICATION
|
11.1
|
MDA
and LICENSEE each agree that all information contained in documents
marked
"confidential" and forwarded to one by the other (1) are to be
received in
strict confidence, (ii) used only for the purposes of this AGREEMENT,
and
(iii) not disclosed by the recipient party (except as required
by law or
court order), 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:
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
(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
(f) is
required by law or regulation to be disclosed.
|
11.2
|
Each
party's obligation of confidence hereunder will 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 will exist while this AGREEMENT is in force and for
a period of
3 years thereafter.
|
|
11.3
|
MDA
reserves the right to publish the general scientific findings from
research related to LICENSED SUBJECT MATTER, with due regard to
the
protection of LICENSEE'S confidential information. MDA will submit
the
manuscript of any proposed publication to LICENSEE at least 30
days before
publication, and LICENSEE shall have the right to review and comment
upon
the publication in order to protect LICENSEE'S confidential information.
Upon LICENSEE'S request, publication may be delayed up to 60 additional
days to enable LICENSEE to secure adequate intellectual property
protection of LICENSEE'S confidential information that would be
affected
by the publication.
|
XII. ASSIGNMENT
|
12.1
|
Except
in connection with the sale of substantially all of LICENSEE's
assets to a
third party, this AGREEMENT may not be assigned by LICENSEE without
the
prior written consent of BOARD, which will not be unreasonably
withheld.
|
XIII. TERM
AND TERMINATION
|
13.1
|
Subject
to Articles 13.2, 13.3 and 13.4 hereinbelow, the term of this AGREEMENT
is
from the EFFECTIVE DATE to the full end of the term or terms for
which
PATENT RIGHTS have not expired, or if only TECHNOLOGY RIGHTS are
licensed
and no PATENT RIGHTS are applicable, for a term of 15
years.
|
|
13.2
|
Any
time after 1 year from the EFFECTIVE DATE, BOARD and MDA have the
right to
terminate this license in any national political jurisdiction within
the
LICENSED TERRITORY if LICENSEE, within 90 days after receiving
written
notice from MDA of the intended termination, fails to provide written
evidence satisfactory to MDA 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
Section 13.2: (i) "commercialize" means having SALES of LICENSED
PRODUCTS
incorporating PATENT RIGHTS or incorporating TECHNOLOGY RIGHTS
in such
jurisdiction; or (ii) “active attempts to commercialize” means 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 incorporating PATENT
RIGHTS
or incorporating TECHNOLOGY RIGHTS in any jurisdiction, and has
provided
plans acceptable to MDA, in its sole discretion, to commercialize
licensed
inventions in the jurisdiction(s) that MDA intends to terminate.
Parties
acknowledge that to the extent LICENSEE is a joint owner of Patent
Rights,
such termination does not inhibit LICENSEE's right to practice
under its
undivided interest in the
invention.
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
|
13.3
|
Subject
to any rights herein which survive termination, this AGREEMENT
will
earlier terminate in its entirety:
|
|
(a)
|
automatically
if LICENSEE shall become bankrupt or insolvent and/or if the business
of
LICENSEE shall be placed in the hands of a receiver or trustee,
whether by
voluntary act of LICENSEE or otherwise;
or
|
|
(b)
|
upon
30 days written notice by MDA if LICENSEE breaches or defaults
on the
payment or report obligations of ARTICLE IV, or use of name obligations
of
ARTICLE X; unless, before the end of the 30 day period, LICENSEE
has cured
the default or breach and so notifies BOARD, stating the manner
of the
cure; or
|
|
(c)
|
upon
90 days written notice from MDA if LICENSEE breaches or defaults
on any
other obligation under this AGREEMENT (such written notice to specify
such
breach or default), unless, before the end of the 90 day period,
LICENSEE
has cured the default or breach and so notifies BOARD, stating
the manner
of the cure; or
|
|
(d)
|
at
any time by mutual written agreement between LICENSEE, MDA and
BOARD, upon
130 days written notice to all parties and subject to any terms
herein
which survive termination; or
|
|
(e)
|
in
relevant part under the provisions of Paragraph 13.2 if
invoked.
|
13.4 If
this
AGREEMENT is terminated for any cause:
|
(a)
|
nothing
herein shall be construed to release either party of any obligation
matured prior to the effective date of the
termination;
|
|
(b)
|
LICENSEE
covenants and agrees to be bound by the provisions of ARTICLES
IX
(indemnification), X (Use of Board and Component's Name) and XI
(Confidential Information) of this
AGREEMENT;
|
|
(c)
|
LICENSEE
may, after the effective date of such termination, SELL all LICENSED
PRODUCTS that it has on hand at the date of termination, if LICENSEE
pays
the earned royalty thereon and any other amounts due pursuant to
ARTICLE
IV of this AGREEMENT.
|
XIV. WARRANTY:
SUPERIOR-RIGHTS
|
14.1
|
Except
for the rights, if any, of the Government of the United States
as set
forth below, BOARD represents and warrants its belief that (1)
it is the
owner of an undivided joint right, title, and interest in and to
LICENSED
SUBJECT MATTER, (2) it has the right to grant an exclusive license
to its
rights, title and interest thereunder, and (3) it has not knowingly
granted licenses thereunder to any other entity that would restrict
rights
granted hereunder except as stated
herein.
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
|
14.2
|
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 Governments rights
under
any such agreement and any applicable law or regulation, including
P.L.
96-517 as amended by P.L. 98-620. To the extent that there is a
conflict
between any such agreement, applicable law or regulation and this
AGREEMENT, the terms of such Government agreement, applicable law
or
regulation shall prevail.
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14.3
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LICENSEE
understands and agrees that BOARD, by this AGREEMENT, makes no
representation as to the operability or fitness for any use, safety,
and
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 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.
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14.4
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LICENSEE,
by execution hereof, acknowledges, covenants and agrees that LICENSEE
has
not been induced in anyway by BOARD, SYSTEM, MDA or employees thereof
to
enter into this Agreement, and further warrants and represents
that (i)
LICENSEE has conducted sufficient due diligence with respect to
all items
and issues pertaining to this Agreement; and (ii) LICENSEE has
adequate
knowledge and expertise, or has used knowledgeable and expert consultants,
to adequately conduct such due diligence, and agrees to accept
all risks
inherent herein.
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XV. GENERAL
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15.1
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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.
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15.2
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Any
notice required by this AGREEMENT shall be given by prepaid, first
class,
certified mail, return receipt requested, and addressed in the
case of
BOARD to:
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BOARD
OF REGENTS
The
University of Texas System
▇▇▇
▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇,
▇▇▇▇▇ ▇▇▇▇▇
ATTENTION:
Office of General Counsel
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With
copy to
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The
University of Texas
M.D.
▇▇▇▇▇▇▇▇ Cancer Center
Office
of Technology Development
▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇,
▇▇▇▇▇ ▇▇▇▇▇
ATTENTION:
▇▇▇▇▇▇▇ ▇. ▇▇▇▇
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INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
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Or
in the case of LICENSEE to:
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President
and CEO
ATTN:
▇▇. ▇▇▇▇▇ ▇. Main
INEX
Pharmaceuticals Corporation
▇▇▇-▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇
▇▇
▇▇▇▇▇▇
▇▇▇▇▇▇
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or
such
other address as may be given from time to time under the terms of this notice
provision.
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15.3
|
LICENSEE
must comply with all applicable federal, state and local laws and
regulations in connection with its activities pursuant to this
AGREEMENT.
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15.4
|
This
AGREEMENT shall be construed and enforced in accordance with the
laws of
the United States of America and of the State of
Texas.
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15.5
|
Failure
of BOARD 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.
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15.6
|
Headings
included herein are for convenience only and shall not be used
to construe
this AGREEMENT.
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15.7
|
If
any part of this AGREEMENT is for any reason to be found unenforceable,
all other parts nevertheless will remain
enforceable.
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IN
WITNESS WHEREOF, parties hereto have caused their duly authorized
representatives to execute this AGREEMENT.
|
THE
UNIVERSITY OF TEXAS
M.D.
▇▇▇▇▇▇▇▇ CANCER CENTER
|
BOARD
OF REGENTS OF THE
UNIVERSITY
OF TEXAS SYSTEM
|
|
By
/s/
▇▇▇▇▇▇▇ ▇. Best
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By
/s/
▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇, M.D.
|
|
▇▇▇▇▇▇▇
▇. Best
Associate
Vice President
For
Business Affairs
Date:
1-24-00
|
▇▇▇▇
▇▇▇▇▇▇▇▇▇▇, M.D.
President,
M.D. ▇▇▇▇▇▇▇▇ Cancer
Center
Date:
2-9-00
|
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APPROVED
AS TO CONTENT:
|
APPROVED
AS TO FORM:
|
|
By
/s/
▇▇▇▇▇▇▇ ▇. ▇▇▇▇
|
By
/s/
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
|
|
▇▇▇▇▇▇▇
▇. ▇▇▇▇
Director,
Technology Development
Date:
01/20/2000
|
▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇, Esq.
Office
of General Counsel
Date:
14
Feb. 00
|
INFORMATION
MARKED BY [***] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. THE OMITTED PORTION HAS BEEN SEPARATELY FILED WITH THE SECURITIES
AND
EXCHANGE COMMISSION.
|
INEX
PHARMACEUTICALS CORPORATION
|
|
|
By
/s/
▇▇▇▇▇ ▇. Main
|
|
|
Name:
▇▇▇▇▇ ▇. Main
Title:
President & CEO
Date:
June
14, 2000
|
EXHIBIT
I
"The
Use
of Liposomal Vincristine in Order to Circumvent Toxicity and Allow
Administration of Higher Doses of Drug", ID99-061
▇▇▇▇▇▇▇
▇. ▇▇▇▇▇▇, M.D., Ph.D., et al
U.S.
Patent Application S.N. 601127,444 filed 01-April-99 entitled
"Compositions
and Methods for Treating Lymphoma"
U.S.
Patent Application S.N. 64/137,194 filed 02-June-99 entitled
"Compositions
and Methods for Treating Lymphoma"