PATENT AND TECHNOLOGY LICENSE AGREEMENT
Exhibit
10.22
CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED
HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST.
OMISSIONS
ARE DESIGNATED AS *. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED
SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
PATENT
AND TECHNOLOGY LICENSE AGREEMENT
This
twenty-seven (27) page AGREEMENT ("AGREEMENT") is made on this 10th day of
January 2006, by and between THE BOARD OF REGENTS ("BOARD") of THE UNIVERSITY
OF
TEXAS SYSTEM ("SYSTEM"), an agency of the State of Texas, whose address is
000
Xxxx 0xx Xxxxxx, Xxxxxx, Xxxxx 00000, on behalf of THE UNIVERSITY OF TEXAS
M. D.
XXXXXXXX CANCER CENTER ("UTMDACC"), a component institution of SYSTEM, and
CALLISTO PHARMACEUTICALS, INC., a Delaware corporation having a principal
place
of business located at 000 Xxxxxxxxx Xxxxxx, Xxxxx 0000, Xxx Xxxx, Xxx Xxxx
00000 (“LICENSEE”).
TABLE
OF CONTENTS
RECITALS
|
Page
2
|
I.
EFFECTIVE DATE
|
Page
2
|
II.
DEFINITIONS
|
Page
2
|
III.
LICENSE
|
Page
4
|
IV.
CONSIDERATION, PAYMENTS AND REPORTS
|
Page
6
|
V.
SPONSORED RESEARCH
|
Page
12
|
VI.
PATENTS AND INVENTIONS
|
Page
12
|
VII.
INFRINGEMENT BY THIRD PARTIES
|
Page
13
|
VIII.
PATENT MARKING
|
Page
14
|
IX.
INDEMNIFICATION AND INSURANCE
|
Page
14
|
X.
USE OF BOARD AND UTMDACC'S NAME
|
Page
16
|
XI.
CONFIDENTIAL INFORMATION AND PUBLICATION
|
Page
16
|
XII.
ASSIGNMENT
|
Page
18
|
XIII.
TERM AND TERMINATION
|
Page
18
|
1
XIV.
WARRANTY: SUPERIOR-RIGHTS
|
Page
21
|
XV.
GENERAL
|
Page
23
|
SIGNATURES
|
Page
26
|
RECITALS
A.
|
BOARD
owns certain PATENT RIGHTS and TECHNOLOGY RIGHTS related to LICENSED
SUBJECT MATTER developed at
UTMDACC.
|
B.
|
BOARD,
through UTMDACC, desires to have the LICENSED SUBJECT MATTER developed
in
the LICENSED FIELD and used for the benefit of LICENSEE, BOARD,
SYSTEM,
UTMDACC, the inventor(s), and the public as outlined in BOARD’s
Intellectual Property Policy.
|
C.
|
LICENSEE
wishes to obtain a license from BOARD to practice LICENSED SUBJECT
MATTER.
|
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 above ("EFFECTIVE
DATE").
|
II. DEFINITIONS
As
used
in this AGREEMENT, the following terms have the meanings indicated:
2.1
|
AFFILIATE
means any business entity more than fifty percent (50%) owned by
LICENSEE,
any business entity which owns more than fifty percent (50%) of
LICENSEE,
or any business entity that is more than fifty percent (50%) owned
by a
business entity that owns more than fifty percent (50%) of
LICENSEE.
|
2.2
|
LICENSED
FIELD
means the fields of human therapeutics and animal
therapeutics.
|
2
2.3
|
LICENSED
PRODUCTS
means any product or service sold by LICENSEE 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 from a SALE 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),
all as
recorded by LICENSEE in LICENSEE’s official books and records in
accordance with generally accepted accounting practices and consistent
with LICENSEE’s published financial statements and/or regulatory filings
with the United States Securities and Exchange
Commission.
|
2.7
|
PATENT
RIGHTS
means BOARD's rights in information or discoveries described
in invention
disclosures, or claimed in any 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 defined in Exhibit I
attached
hereto.
|
2.8 | PHASE II CLINICAL STUDY means: (a) that portion of the drug development and review process which provides for early controlled clinical studies conducted to obtain preliminary data on the effectiveness of an investigational new drug for a particular indication, as more specifically defined by the rules and regulations of the FDA, |
3
including 21 C.F.R.§ 312.21 or any future revisions or substitutes therefor; or (b) a similar clinical study in any national jurisdiction other than the United States. |
2.9
|
PHASE
IIb CLINICAL STUDY
means that portion of a PHASE II CLINICAL STUDY involving controlled
dose
ranging to evaluate the efficacy and safety of an investigational
new drug
in the target patient population and to define the optimal dosing
regimen.
|
2.10
|
SALE
or SOLD
means the transfer or disposition of a LICENSED PRODUCT for value
to a
party other than LICENSEE or
AFFILIATE.
|
2.11
|
TECHNOLOGY
RIGHTS
means 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 UTMDACC before the EFFECTIVE DATE, which
are not
claimed in PATENT RIGHTS but that are necessary for practicing
PATENT
RIGHTS.
|
III. LICENSE
3.1 | BOARD, through UTMDACC, hereby grants to LICENSEE a royalty-bearing, exclusive license under LICENSED SUBJECT MATTER to manufacture, have manufactured, use, import, offer to sell and/or sell LICENSED PRODUCTS within LICENSED TERRITORY for use within LICENSED FIELD. This grant is subject to Sections 14.2 and 14.3 hereinbelow, the payment by LICENSEE to UTMDACC of all consideration as provided herein, the timely payment of all amounts due under any related sponsored research agreement between UTMDACC and LICENSEE in effect during this |
4
AGREEMENT, and is further subject to the following rights retained by BOARD and UTMDACC to: |
(a)
|
Publish
the general scientific findings from research related to LICENSED
SUBJECT
MATTER, subject to the terms of Article XI-Confidential Information
and
Publication; and
|
(b)
|
Use
LICENSED SUBJECT MATTER for research, teaching, patient care, and
other
educationally-related, non-commercial
purposes.
|
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. LICENSEE agrees to deliver such contract to
UTMDACC
within thirty (30) calendar days following execution
thereof.
|
3.3
|
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.
|
3.4
|
LICENSEE
must deliver to UTMDACC a true and correct copy of each sublicense
granted
by LICENSEE, and any modification or termination thereof, within
thirty
(30) calendar days after execution, modification, or
termination.
|
5
3.5
|
If
this AGREEMENT is terminated pursuant to Article XIII-Term and
Termination, BOARD and UTMDACC agree to accept as successors
to LICENSEE,
existing sublicensees in good standing at the date of termination
provided
that each such sublicensee consents in writing to be bound by
all of the
terms and conditions of this
AGREEMENT.
|
3.6
|
UTMDACC
grants LICENSEE an exclusive option to negotiate a worldwide,
royalty-bearing exclusive license to any Improvements created
by Xx.
Xxxxxxxx Xxxxxx at UTMDACC for two years from the EFFECTIVE DATE.
For the
purpose of this Section, “Improvements” means any analogs or derivative
compounds based on the activity or structure of Tyrphostins.
Such option
shall be exercisable in the following manner: UTMDACC will promptly
notify
LICENSEE of any Improvements that are disclosed to its Office
of
Technology Commercialization. LICENSEE shall have three (3) months
from
such disclosure to notify UTMDACC of its desire to enter into
such a
license agreement, and a license agreement shall be negotiated
in good
faith within a period not to exceed six (6) months from LICENSEE's
notification to UTMDACC of its desire to enter into a license
agreement,
or such period of time as to which the parties shall mutually
agree.
UTMDACC agrees that any license negotiated for Improvements will
contain
appropriate royalty stacking language which will prevent UTMDACC
from
receiving a royalty pursuant to both this AGREEMENT and any negotiated
license for the Improvements.
|
6
IV. CONSIDERATION,
PAYMENTS AND REPORTS
4.1
|
In
consideration of rights granted by BOARD to LICENSEE under this
AGREEMENT,
LICENSEE agrees to pay UTMDACC the
following:
|
(a)
|
All
out-of-pocket expenses incurred by UTMDACC in filing, prosecuting,
enforcing and maintaining PATENT RIGHTS, and all such future expenses
incurred by UTMDACC, for so long as, and in such countries as this
AGREEMENT remains in effect. UTMDACC will invoice LICENSEE within
thirty
(30) calendar days of the EFFECTIVE DATE for expenses incurred
as of that
time and on a quarterly basis thereafter. The invoiced amounts
will be due
and payable by LICENSEE within thirty (30) calendar days of invoice;
and
|
(b)
|
A
nonrefundable 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 thirty (30) calendar days after
the
AGREEMENT has been fully executed by all parties;
and
|
(c)
|
Nonrefundable
annual license maintenance fees as
follows:
|
(i)
|
year
one - $*, due within thirty (30) days of the first anniversary
of the
EFFECTIVE DATE;
|
(ii)
|
year
two - $*, due within thirty (30) days of the second anniversary
of the
EFFECTIVE DATE;
|
(iii)
|
year
three - $*, due within thirty (30) days of the third anniversary
of the
EFFECTIVE DATE;
|
7
|
|
(iv)
|
year
four - $*, due within thirty (30) days of the fourth anniversary
of the
EFFECTIVE DATE;
|
(v)
|
year
five - $*, due within thirty (30) days of the fifth anniversary
of the
EFFECTIVE DATE; and
|
(vi)
|
year
six and each subsequent year - $*, due within thirty (30) days
of the
seventh anniversary of the EFFECTIVE DATE and every anniversary
of the
EFFECTIVE DATE thereafter, provided that, upon the first SALE,
the annual
maintenance fee for that year and subsequent years will become
a
guaranteed minimum annual royalty of $* per year.
|
These
annual maintenance fees will be offset against any payments paid that are
otherwise due pursuant to Section 4.1(d); and
(d)
|
A
running royalty as follows:
|
(i)
|
*
percent (*%) of NET SALES up to and including $* in NET SALES;
and
|
(ii) *
percent
(*%) of NET SALES in excess of $*; and
(e)
|
Milestone
payments as follows due for each LICENSED PRODUCT used as a therapeutic:
|
(i)
|
$*
due within thirty (30) days of an NDA filing for each LICENSED
PRODUCT.
As
used herein, “NDA filing” shall mean the filing of a New Drug Application
(as described in 21 C.F.R.§ 314.50 et. seq. or any future revisions or
substitutes therefor) or a similar application seeking
|
8
Marketing Approval, as defined below, in the United States or a country other than the United States; |
(ii)
|
$*
due within thirty (30) days of Marketing Approval of each LICENSED
PRODUCT. “Marketing
Approval” means the approval or authorization required
for the marketing, promotion and sale of LICENSED PRODUCT in a
country,
such as the issuance of an approval action on an NDA in the United
States,
or the issuance of its equivalent in a country other than the United
States;
and
|
(iii)
|
$*
due within thirty (30) days of the first SALE of each LICENSED
PRODUCT;
and
|
(f)
|
The
following percentage of all consideration (other than (i) research
and
development money; (ii) payments received by LICENSEE from a sublicense
as
a result of the purchase or sale of debt or equity securities of
LICENSEE
by such sublicense; or (iii) monies received for the same milestone
events
outlined in Section 4.1(e)) received by LICENSEE from either (i)
any
sublicensee pursuant to Sections 3.3 and 3.4 hereinabove, or (ii)
any
assignee pursuant to Section 12.1 hereinbelow (in consideration
for
UTMDACC allowing the assignment), including but not limited to,
royalties,
up-front payments, marketing, distribution, franchise, option,
license, or
documentation fees, bonus, and certain milestone payments and equity
securities not excluded above:
|
(i)
|
prior
to completion of a Phase IIb Clinical Study - * percent (*%);
and
|
(ii)
|
on
or after completion of Phase IIb Clinical Study -
*
percent (*%).
|
9
4.2
|
Unless
otherwise provided, all such payments are payable within thirty
(30)
calendar 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 UTMDACC a true and accurate report, giving such
particulars of the business conducted by LICENSEE and its sublicensees,
if
any exist, during the preceding three calendar months under this
AGREEMENT
as necessary for UTMDACC to account for LICENSEE's payments hereunder.
This report will include pertinent data, including, but not limited
to:
|
(a)
|
the
accounting methodologies used to account for and calculate the
items
included in the report and any differences in such accounting
methodologies used by LICENSEE since the previous report;
and
|
(b)
|
a
list of LICENSED PRODUCTS produced for the three (3) preceding
calendar
months categorized by the technology it relates to under PATENT
RIGHTS;
and
|
(c)
|
the
total quantities of LICENSED PRODUCTS produced by the category
listed in
Section 4.2(b); and
|
(d)
|
the
total SALES by the category listed in Section 4.2(b); and
|
(e)
|
the
calculation of NET SALES by the category listed in Section 4.2(b);
and
|
(f)
|
the
royalties so computed and due UTMDACC by the category listed in
Section
4.2(b) and/or minimum royalties; and
|
(g)
|
all
consideration received from each sublicensee or assignee and payments
due
UTMDACC; and
|
(h) | all other amounts due UTMDACC herein. |
10
Simultaneously
with the delivery of each such report, LICENSEE agrees to pay UTMDACC the
amount
due, if any, for the period of such report. These reports are required even
if
no payments are due.
4.3
|
During
the term of this AGREEMENT and for one (1) year thereafter, LICENSEE
agrees to keep complete and accurate records of its and its sublicensees'
SALES and NET SALES in sufficient detail to enable the royalties
and other
payments due hereunder to be determined. LICENSEE agrees to permit
UTMDACC
or its representatives, at UTMDACC's expense, to periodically examine
LICENSEE’s 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 any amounts due UTMDACC are determined
to have
been underpaid in an amount equal to or greater than five percent
(5%) of
the total amount due during the period so examined, then LICENSEE
will pay
the cost of the examination plus accrued interest at the highest
allowable
rate.
|
4.4
|
Within
thirty (30) calendar days following each anniversary of the EFFECTIVE
DATE, LICENSEE will deliver to UTMDACC a written progress report
as to
LICENSEE's (and any sublicensee’s) 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.
|
4.5
|
All
amounts payable hereunder by LICENSEE will be paid 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.
Xxxxxxxx
Cancer Center, and sent by
|
00
Xxxxxx
Xxxxxx mail to Xxx 000000, Xxxxxxx, Xxxxx 00000, Attention: Manager, Sponsored
Programs or by wire transfer to:
BANK
ONE
TEXAS
000
XXXXXX
XXXXXXX,
XXXXX 00000
SWIFT:
BONEUS44HOU
ABA
ROUTING NO: 000000000
ACCOUNT
NAME: UNIV.
OF
TEXAS M. D. XXXXXXXX CANCER CENTER
ACCOUNT
NO: 1586838979
REFERENCE: include
title and EFFECTIVE DATE of AGREEMENT and type of payment (e.g., license
documentation fee, milestone payment, royalty [including applicable
patent/application identified by MDA reference number and patent number or
application serial number], or maintenance fee, etc.).
4.6
|
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
(a) will notify UTMDACC in writing of all opportunities to conduct
this
sponsored research (including clinical trials, if applicable),
(b) solicit
research and/or clinical proposals from UTMDACC for this purpose,
and (c)
will give good faith consideration to funding the proposals at
UTMDACC.
|
VI. PATENTS
AND INVENTIONS
6.1
|
If
after consultation with LICENSEE both parties agree that a new
patent
application should be filed for LICENSED SUBJECT MATTER, LICENSEE
will pay
the cost of
|
12
|
searching,
preparing, filing, prosecuting and maintaining same. UTMDACC
will keep
LICENSEE fully informed on a timely basis of all activity on
the filings
related to the LICENSED SUBJECT MATTER and will provide LICENSEE
with a
copy of all applications and any documents received or filed
during
prosecution thereof for which LICENSEE has paid the cost of filing.
For all applications and responses to office actions filed during
the term
of this AGREEMENT, LICENSEE will timely provide UTMDACC an initial
draft
and UTMDACC will review, finalize and file such documents. If
LICENSEE
notifies UTMDACC that it does not intend to pay the cost of an
application, or if LICENSEE does not respond or make an effort
to agree
with UTMDACC on the disposition of rights of the subject invention,
then
UTMDACC may file such application at its own expense and LICENSEE’s rights
to such invention under this AGREEMENT shall terminate in their
entirety.
The
parties agree that they share a common legal interest to get
valid
enforceable patents and that LICENSEE will keep all privileged
information
received pursuant to this Section
confidential.
|
VII. INFRINGEMENT
BY THIRD PARTIES
7.1
|
LICENSEE,
at its expense, must enforce any patent exclusively licensed hereunder
against infringement by third parties and is entitled to retain
recovery
from such enforcement. After reimbursement of LICENSEE’s reasonable legal
costs and expenses related to such recovery, LICENSEE agrees to
pay
UTMDACC either: (a) the royalty detailed in Section 4.1(d) for
any
monetary recovery that is for sales of LICENSED PRODUCTS lost due
to the
infringement and fifty percent (50%) of punitive damages for willful
infringement; or (b) fifty percent (50%) of reasonable royalties
awarded
and
|
13
punitive damages for willful infringement in any recovery in which the award is for reasonable royalties. LICENSEE must notify UTMDACC in writing of any potential infringement within thirty (30) calendar days of knowledge thereof. If LICENSEE decides not to pursue an infringement enforcement action within six month of knowledge of such infringement, LICENSEE will notify UTMDACC and then BOARD or UTMDACC may, at its discretion, after considering the commercially reasonable bases for LICENSEE’s decision not to pursue such infringement enforcement action, pursue the enforcement of any patent licensed hereunder on behalf of itself and LICENSEE. In such case, the parties will discuss in good faith the appropriate settlement of such case and/or the appropriate distribution of any recovery from such action, which shall depend on LICENSEE’s involvement and effect of the LICENSEE’s ability to commercialize the LICENSED SUBJECT MATTER. |
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 during regular business
hours, to
all relevant personnel, records, papers, information, samples,
specimens,
and the like in its possession.
|
VIII. PATENT
MARKING
8.1
|
LICENSEE
agrees that all packaging containing individual LICENSED PRODUCT(S),
documentation therefor, and when possible for actual LICENSED PRODUCT(S)
sold by LICENSEE, AFFILIATES, and/or sublicensees of LICENSEE will
be
permanently and legibly marked with the number of any applicable
patent(s)
licensed hereunder in accordance with each country's patent laws,
including Xxxxx 00, Xxxxxx Xxxxxx
Code.
|
14
IX. INDEMNIFICATION
AND INSURANCE
9.1
|
LICENSEE
agrees to hold harmless and indemnify BOARD, SYSTEM, UTMDACC,
its Regents,
officers, employees, students and agents 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
rights granted hereunder by LICENSEE, its officers, its AFFILIATES
or
their officers, employees, agents or
representatives.
|
9.2
|
In
no event shall BOARD, SYSTEM or UTMDACC be liable for any indirect,
special, consequential or punitive damages (including, without
limitation,
damages for loss of profits or expected savings or other economic
losses,
or for injury to persons or property) arising out of, or in connection
with, this AGREEMENT or its subject matter, regardless of whether
BOARD,
SYSTEM or UTMDACC knows or should know of the possibility of such
damages.
|
9.3 |
Beginning
at the time when any LICENSED SUBJECT MATTER is being distributed
or sold
(including for the purpose of obtaining regulatory approvals) by
LICENSEE
or by a sublicensee, LICENSEE shall, at its sole cost and expense,
procure
and maintain commercial general liability insurance in amounts
not less
than $2,000,000 per incident and $2,000,000 annual aggregate, and
LICENSEE
shall use reasonable efforts to have the BOARD, SYSTEM, UTMDACC,
its
Regents, officers, employees, students and agents named as additional
insureds. Such commercial general liability insurance shall provide:
(i)
product liability coverage; (ii) broad form contractual liability
coverage
for
|
15
LICENSEE's indemnification under this AGREEMENT; and (iii) coverage for litigation costs. The minimum amounts of insurance coverage required herein shall not be construed to create a limit of LICENSEE's liability with respect to its indemnification under this AGREEMENT. |
9.4
|
LICENSEE
shall provide UTMDACC with written evidence of such insurance within
thirty (30) days of its procurement. Additionally, LICENSEE shall
provide
UTMDACC with written notice of at least fifteen (15) days prior
to the
cancellation, non-renewal or material change in such insurance.
|
9.5
|
LICENSEE
shall maintain such commercial general liability insurance beyond
the
expiration or termination of this AGREEMENT during: (i) the period
that
any LICENSED SUBJECT MATTER developed pursuant to this AGREEMENT
is being
commercially distributed or sold by LICENSEE or by a sublicensee
or agent
of LICENSEE; and (ii) the five (5) year period immediately after
such
period.
|
X.
USE OF BOARD AND UTMDACC'S NAME
10.1
|
LICENSEE
will not use the name of (or the name of any employee of) UTMDACC,
SYSTEM
or BOARD in any advertising, promotional or sales literature, on
its Web
site, or for the purpose of raising capital without the advance
express
written consent of BOARD secured
through:
|
The
University of Texas
X. X.
Xxxxxxxx Cancer Center, Legal Services
X.X.
Xxx
000000, Xxxx 0000
Xxxxxxx,
XX 00000-0000
ATTENTION:
Xxxxxxx Xxxxxx
Email:
xxxxxxx@xxxxxxxxxx.xxx
16
Notwithstanding
the above, LICENSEE may use the name of (or name of employee of) UTMDACC,
SYSTEM
or BOARD in routine business correspondence, or as needed in appropriate
regulatory submissions without express written consent.
XI. CONFIDENTIAL
INFORMATION AND PUBLICATION
11.1
|
UTMDACC
and LICENSEE each agree that all information contained in documents
marked
"confidential" and forwarded to one by the other (i) are to be
received in
strict confidence, (ii) are to be used only for the purposes of
this
AGREEMENT, and (iii) will not be 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 by competent written proof that such
information:
|
(a)
|
was
in the public domain at the time of disclosure;
or
|
(b)
|
later
became part of the public domain through no act or omission of
the
recipient party, its employees, agents, successors or assigns;
or
|
(c)
|
was
lawfully disclosed to the recipient party by a third party having
the
right to disclose it; or
|
(d)
|
was
already known by the recipient party at the time of disclosure;
or
|
(e)
|
was
independently developed by the recipient party without use of the
other
party’s confidential information; 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
|
17
own confidential information, but always at least a reasonable degree of care. This obligation will exist while this AGREEMENT is in force and for a period of three (3) years thereafter. |
11.3
|
UTMDACC
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. UTMDACC will submit the
manuscript of any proposed publication to LICENSEE at least thirty
(30)
calendar 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 sixty (60) additional calendar days to enable LICENSEE
to
secure adequate intellectual property protection of LICENSEE’s
confidential information that would otherwise be affected by the
publication.
|
XII. ASSIGNMENT
12.1
|
Except
in connection with the sale of all of LICENSEE's assets to a third
party,
this AGREEMENT may not be assigned by LICENSEE without the prior
written
consent of UTMDACC, which will not be unreasonably
withheld.
|
XIII. TERM
AND TERMINATION
13.1
|
Subject
to Sections 13.3, 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.
|
13.2
|
Any
time after two (2) years from the EFFECTIVE DATE, BOARD or UTMDACC
have
the right to terminate this license in any national political jurisdiction
within the
|
18
LICENSED TERRITORY if LICENSEE, within ninety (90) calendar days after receiving written notice from UTMDACC of the intended termination, fails to provide written evidence satisfactory to UTMDACC that LICENSEE or its sublicensee(s) has commercialized or is actively and effectively attempting to commercialize a licensed invention in such jurisdiction(s). The following definitions apply to Section 13.2: (a) "commercialize" means having SALES in such jurisdiction; (b) "active attempts to commercialize" means having an effective, ongoing and active research, development, manufacturing, marketing or sales program as appropriate, directed toward obtaining regulatory approval, and/or production and/or SALES in any jurisdiction, and has provided plans acceptable to UTMDACC, in its sole discretion, to commercialize licensed inventions in the jurisdiction(s) that UTMDACC intends to terminate. |
13.3
|
Subject
to any rights herein which survive termination, this AGREEMENT
will
earlier terminate in its entirety:
|
(a)
|
automatically,
if LICENSEE becomes bankrupt or insolvent and/or if the business
of
LICENSEE shall be placed in the hands of a receiver, assignee,
or trustee,
whether by voluntary act of LICENSEE or otherwise;
or
|
(b)
|
upon
thirty (30) calendar days written notice from UTMDACC, 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
such thirty (30)-calendar day notice period, LICENSEE has cured
the
default or breach to UTMDACC’s satisfaction, and so notifies UTMDACC,
stating the manner of the cure; or
|
19
(c)
|
upon
ninety (90) calendar days written notice from UTMDACC if LICENSEE
breaches
or defaults on any other obligation under this AGREEMENT, unless,
before
the end of the such ninety (90) calendar-day notice period, LICENSEE
has
cured the default or breach to UTMDACC’s satisfaction and so notifies
UTMDACC, stating the manner of the cure; or
|
(d)
|
at
any time by mutual written agreement between LICENSEE and UTMDACC
upon one
hundred eighty (180) calendar days written notice to all parties
and
subject to any terms herein which survive termination;
or
|
(e)
|
if
Section 13.2 is invoked; or
|
(f)
|
if
LICENSEE has defaulted or been late on its payment obligations
pursuant to
the terms of this AGREEMENT on any two (2) occasions in a twelve
(12)
month period.
|
13.4 | Upon termination of this AGREEMENT: |
|
(a)
|
nothing
herein will be construed to release either party of any obligation
maturing prior to the effective date of the termination;
and
|
(b)
|
LICENSEE
covenants and agrees to be bound by the provisions of Articles
IX
(Indemnification and Insurance), X (Use of Board and UTMDACC’s Name) and
XI (Confidential Information and Publication) of this AGREEMENT;
and
|
(c)
|
LICENSEE
may, after the effective date of the termination, sell all LICENSED
PRODUCTS and parts therefor 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; and
|
20
(d)
|
Subject
to Section 13.4(c), LICENSEE
agrees to cease and desist any use and all SALE of the LICENSED
SUBJECT
MATTER and LICENSED PRODUCTS upon termination of this AGREEMENT;
and
|
(e)
|
LICENSEE
grants to BOARD and UTMDACC a nonexclusive royalty bearing license
with
the right to sublicense others with respect to improvements made
by
LICENSEE (including improvements licensed by LICENSEE from third
parties)
in the LICENSED SUBJECT MATTER. LICENSEE and UTMDACC agree to negotiate
in
good faith the royalty rate for the nonexclusive license. BOARD's
and
UTMDACC’s right to sublicense others hereunder is solely for the purpose
of permitting others to develop and commercialize the entire technology
package.
|
XIV. WARRANTY:
SUPERIOR-RIGHTS
14.1
|
Except
for the rights, if any, of the Government of the United States
of America
as set forth below and except as set forth in Section 14.5, BOARD
represents and warrants its belief that (a) it is the owner of
the entire
right, title, and interest in and to LICENSED SUBJECT MATTER, (b)
it has
the sole right to grant licenses thereunder, and (c) it has not
knowingly
granted licenses thereunder to any other entity that would restrict
rights
granted hereunder except as stated
herein.
|
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 Government's rights
under
any such agreement and any applicable law or regulation, including
P.L.
96-517 as amended by
|
21
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. LICENSEE agrees that LICENSED PRODUCTS used or SOLD in the United States will be manufactured substantially in the United States, unless a written waiver is obtained in advance from the GOVERNMENT. |
14.3
|
LICENSEE
understands and agrees that BOARD and UTMDACC, by this AGREEMENT,
make 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 and UTMDACC, by this AGREEMENT, also make no representation
as to
whether any patent covered by PATENT RIGHTS is valid or as to
whether
there are any patents now held, or which will be held, by others
or by
BOARD or UTMDACC in the LICENSED FIELD, nor does BOARD and UTMDACC
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.
|
14.4 | LICENSEE, by execution hereof, acknowledges, covenants and agrees that LICENSEE has not been induced in any way by BOARD, SYSTEM, UTMDACC or employees thereof to enter into this AGREEMENT, and further warrants and represents that (a) LICENSEE has conducted sufficient due diligence with respect to all items and issues pertaining to this AGREEMENT; and (b) LICENSEE has adequate knowledge and |
22
expertise, or has used knowledgeable and expert consultants, to adequately conduct such due diligence, and agrees to accept all risks inherent herein. |
14.5
|
LICENSEE
understands and acknowledges that Xx. Xxxxxx Lesyng, of Warsaw,
Poland,
has asserted that he is a co-inventor on the patent applications
under
PATENT RIGHTS. If appropriate, UTMDACC will add Dr. Lesyng as an
inventor
to such applications. UTMDACC will consult with LICENSEE prior
to any
decision to add Dr. Lesyng as an inventor. If the decision is made
to add
Dr. Lesyng as an inventor, LICENSEE shall have a sixty (60) day
option
period to notify UTMDACC that it desires to take a non-exclusive
lincese,
in which case the parties will work together in good faith to promptly
terminate this agreement and contemporaneously enter into a non-exclusive
license to the LICENSED SUBJECT MATTER based on UTMDACC’s standard form
and all appropriate consideration (e.g., annual license maintenance
fees,
running royalties, and milestone payments) due after the effective
date of
the non-exclusive license will be reduced from this AGREEMENT by
thirty
percent (30%).
|
XV. 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 will be made
except
by a written document signed by both
parties.
|
15.2
|
Any
notice required by this AGREEMENT must be given by prepaid, first
class,
certified mail, return receipt requested, and addressed in the
case of
UTMDACC to:
|
00
Xxx
Xxxxxxxxxx xx Xxxxx M. D. Xxxxxxxx Cancer Center
Office
of
Technology Commercialization
0000
X.
Xxxx, Xxxxx 000, Xxxx 0000
Xxxxxxx,
Xxxxx 00000
ATTENTION:
Xxxxxxx X. Xxxx
with
copy
to BOARD:
BOARD
OF
REGENTS
The
University of Texas System
000
Xxxx
Xxxxxxx Xxxxxx
Xxxxxx,
Xxxxx 00000
ATTENTION:
Office of General Counsel
or
in the
case of LICENSEE to:
Callisto
Pharmaceuticals, Inc.
000
Xxxxxxxxx Xxxxxx, Xxxxx 0000
Xxx
Xxxx,
Xxx Xxxx 00000
ATTENTION:
Xxxx X. Xxxxx, Ph.D., CEO
or
other
addresses as may be given from time to time under the terms of this notice
provision.
15.3
|
LICENSEE
must comply with all applicable federal, 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, without
regard to
its conflict of law provisions. Xxx Xxxxx Xxxxx Xxxxxx xx Xxxxxx
Xxxxxx,
Xxxxx (or, if there is exclusive federal jurisdiction, the United
States
District Court for the Southern District of Texas) shall have exclusive
jurisdiction and venue over any dispute arising out of this AGREEMENT,
and
LICENSEE consents to the jurisdiction of such courts; however,
nothing
herein shall be deemed as a waiver by BOARD, SYSTEM or UTMDACC
of its
sovereign immunity.
|
24
15.5
|
Any
dispute or controversy arising out of or relating to this AGREEMENT,
its
construction or its actual or alleged breach will be decided by
mediation.
If the mediation does not result in a resolution of such dispute
or
controversy, it will be finally decided by an appropriate method
of
alternate dispute resolution, including without limitation, arbitration,
conducted in the city of Houston, Xxxxxx County, Texas, in accordance
with
the applicable, then-current procedures of the American Arbitration
Association. The arbitration panel will include members knowledgeable
in
the evaluation of the LICENSED SUBJECT MATTER. Judgment upon the
award
rendered may be entered in the highest court or forum having jurisdiction,
state or federal. The provisions of this Section 15.5 will not
apply to
decisions on the validity of patent claims or to any dispute or
controversy as to which any treaty or law prohibits such arbitration.
The
decision of the arbitration must be sanctioned by a court of law
having
jurisdiction to be binding upon and enforceable by the
parties.
|
15.6 | Failure of BOARD or UTMDACC to enforce a right under this AGREEMENT will not act as a waiver of right or the ability to later assert that right relative to the particular situation involved. |
15.7 | Headings included herein are for convenience only and will not be used to construe this AGREEMENT. |
15.8 | If any part of this AGREEMENT is for any reason found to be unenforceable, all other parts nevertheless will remain enforceable. |
25
IN
WITNESS WHEREOF,
the
parties hereto have caused their duly authorized representatives to execute
this
AGREEMENT.
BOARD
OF REGENTS OF THE
UNIVERSITY
OF TEXAS SYSTEM
|
CALLISTO
PHARMACEUTICALS, INC.
|
||
/s/ Xxxx Xxxxxxxxxx | /s/ Xxxx X. Xxxxx | ||
|
|
||
Xxxx
Xxxxxxxxxx, M.D.
President
The
University of Texas
M.
D. Xxxxxxxx Cancer Center
Date:
1/10/06
|
Xxxx
X. Xxxxx, Ph.D.
Chief
Executive Officer
Date:12/7/05
|
THE
UNIVERSITY OF TEXAS
M.
D. XXXXXXXX CANCER CENTER
|
||
/s/ Xxxx Xxxxx | ||
|
||
Xxxx
Xxxxx
Executive
Vice President
The
University of Texas
M.
D. Xxxxxxxx Cancer Center
Date:
1/6/06
|
Approved as to Content: | ||
/s/ Xxxxxxxxxxx X. Xxxxxxx | ||
|
||
Xxxxxxxxxxx
X. Xxxxxxx, M.D.
Vice
President, Technology Transfer
M.
D. Xxxxxxxx Cancer Center
Date:
12/15/05
|
26
EXHIBIT
I
MDA03-123
“Novel Mechanistically Altered Tyrphostins with Potent Antitumor Activity,”
UTSC832US; Inventors: Xxxxxxxx Xxxxxx, Ph.D., Xxxxxxxx X. Xxxxxx, Ph.D.,
Xxxxx
Xxxxxx, Ph.D., Xxxxxxxxx Xxxxxxxx, Ph.D., Isabela Fokt, Ph.D., Xxxxxxxx X.
Xxxxxxxxx, Ph.D;
U.S.
Provisional Application No. 60/528,877, filed December 11, 2003 entitled
“Compounds for Treatment of Cell Proliferative Diseases”;
U.S.
Patent Application No. 11/010,834, filed December 13, 2004, entitled “Compounds
for Treatment of Cell Proliferative Diseases”;
PCT/US2004/04712,
filed December 13, 2004, entitled “Compounds for Treatment of Cell Proliferative
Diseases.”
27