CONFIDENTIAL
EXHIBIT 10.1
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 thirty-seven (37) page AGREEMENT ("AGREEMENT") is made on this
12th day of August, 2004, 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 3
II. DEFINITIONS Page 3
III. LICENSE Page 5
IV. CONSIDERATION, PAYMENTS AND REPORTS Page 7
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 17
XII. ASSIGNMENT Page 19
XIII. TERM AND TERMINATION Page 19
XIV. WARRANTY: SUPERIOR-RIGHTS Page 22
XV. GENERAL Page 24
SIGNATURES Page 26
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RECITALS
A. In 1988, BOARD, The University of Texas System Cancer Center (now
UTMDACC) and Argus Pharmaceuticals, Inc. ("ARGUS") entered into an
Exclusive License Agreement (ORIGINAL LICENSE) for certain technologies
relating to LICENSED SUBJECT MATTER developed at UTMDACC.
B. In 2004, the BOARD, UTMDACC and ARONEX (as successor in interest to
ARGUS), reached an agreement to return rights to certain of the
licensed technologies to BOARD ("RETURNED TECHNOLOGY") by amending the
ORIGINAL LICENSE to exclude the RETURNED TECHNOLOGY from Schedule I and
by granting the BOARD a limited license to U.S. Application No.
09/122,427. The parties also agreed that ARONEX would provide certain
information relating to the RETURNED TECHNOLOGY to UTMDACC/BOARD, which
information could be disclosed to third party licensees of the RETURNED
TECHNOLOGY subject to certain restrictions. BOARD, UTMDACC and ARONEX'
agreement is embodied in Amendment No. 6 to the ORIGINAL LICENSE
("AMENDMENT NO. 6"), excerpts of which are attached hereto as Exhibit
II ("EXCERPTS").
C. 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.
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D. 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 ARONEX PATENT shall mean U. S. Patent Application No. 09/122,427 (MDA
94-031 CON), its foreign equivalents, and any divisionals,
continuations, resissues, reexaminations or extensions thereof.
2.3 LICENSED FIELD with respect to LICENSED SUBJECT MATTER other than the
subject matter of the ARONEX PATENT shall mean all fields of use.
LICENSED FIELD with respect to the subject matter of the ARONEX PATENT
shall mean: (1) compositions containing, as an active ingredient,
Anthracyclines or related DNA-binding agents, such as those exemplified
by Annamycin, its derivatives or analogs; (2) methods of delivering
said compositions to a patient, tissue or other target; and (3) methods
for manufacturing such compositions.
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2.4 LICENSED PRODUCTS means any product or service sold by LICENSEE
comprising LICENSED SUBJECT MATTER pursuant to this AGREEMENT and that
is covered by: (i) a claim in a pending patent application, which claim
was filed in good faith, is being diligently prosecuted, and has not
been abandoned and finally disallowed without the possibility of appeal
or refiling; or (ii) a claim in an issued, unexpired patent that has
not been withdrawn, canceled or disclaimed, or held invalid by a
non-appealed or unappealable decision by a court or other appropriate
body of competent jurisdiction.
2.5 LICENSED SUBJECT MATTER means inventions and discoveries covered by
PATENT RIGHTS or TECHNOLOGY RIGHTS within LICENSED FIELD.
2.6 LICENSED TERRITORY means the whole world.
2.7 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.
2.8 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. Notwithstanding the foregoing,
with respect to the ARONEX PATENT, PATENT RIGHTS shall not exceed the
scope of rights returned to the BOARD under Section 11 of AMENDMENT NO.
6.
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2.9 SALE OR SOLD means the transfer or disposition of a LICENSED PRODUCT
for value to a party other than LICENSEE or AFFILIATE.
2.10 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. Notwithstanding the foregoing,
with respect to the ARONEX PATENT, TECHNOLOGY RIGHTS shall not exceed
the scope of rights returned to the BOARD under Section 11 of AMENDMENT
NO. 6.
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, 14.3 and 14.4 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 AGREEMENT,
and is further subject to the following rights retained by BOARD and
UTMDACC to:
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(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 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, acting under applicable law and in
a timely manner, agrees to use its best reasonable efforts to collect
all consideration owed to LICENSEE, including having the sublicensee
agreement confirmed or rejected by a court of proper jurisdiction, if
commercially reasonable.
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.
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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.
IV. CONSIDERATION, PAYMENTS AND REPORTS
4.1 In consideration of rights granted by BOARD to LICENSEE under this
AGREEMENT, LICENSEE agrees to pay to UTMDACC (except for those payments
made directly to third parties as provided in subsection 4.1(a)) the
following:
(a) All out-of-pocket expenses incurred after the EFFECTIVE DATE of
this agreement in filing, prosecuting, enforcing and maintaining
PATENT RIGHTS. Said expenses will be paid directly by LICENSEE to
the appropriate patent office, patent attorney or agent, or other
relevant party or entity. In addition, LICENSEE shall pay to
UTMDACC out-of-pocket expenses incurred by UTMDACC prior to the
EFFECTIVE DATE in filing, prosecuting, enforcing and maintaining
PATENT RIGHTS in the amount of $31,497.00. Said out-of-pocket
expenses shall be paid to UTMDACC within thirty (30) calendar days
of the date this AGREEMENT is executed by all parties and LICENSEE
has received an invoice for the amount from UTMDACC;
(b) A license fee in the amount of one hundred thousand dollars
($100,000.00). This fee will not reduce the amount of any other
payment provided for in this Article IV, and is due and payable
within thirty (30) calendar days after the AGREEMENT has been
fully executed by all parties and LICENSEE has received an invoice
for the amount from UTMDACC;
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(c) A running royalty equal to * percent (*%) of LICENSEE's NET SALES
up to and including * dollars ($*) and a running royalty equal to
* percent (*%) of LICENSEE's NET SALES for LICENSEE'S NET SALES in
excess of * dollars ($*);
(d) Milestone payments upon occurrence of the following events:
(i) upon acceptance of a first New Drug Application (NDA) by the
Food and Drug Administration for a LICENSED PRODUCT, *
dollars ($*); and
(ii) upon approval of the first NDA for any LICENSED PRODUCT, *
dollars ($*);
(e) For any sublicense pursuant to Sections 3.3 and 3.4 hereinabove,
which sublicense is executed prior to completion by LICENSEE of a
Phase IIb clinical trial of a LICENSED PRODUCT, * percent (*%) of
all royalties, up front payments, and milestone payments received
by LICENSEE therefrom; and
(f) For any sublicense pursuant to Sections 3.3 and 3.4 hereinabove,
which sublicense is executed on or after completion by LICENSEE of
a Phase IIb clinical trial of a LICENSED PRODUCT
(i) * percent (*%) of royalties received by LICENSEE therefrom,
and
(ii) * percent (*%) of any milestone payments and up front
payments received by LICENSEE therefrom.
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4.2 LICENSEE, in furtherance of the objectives of this AGREEMENT, agrees to
make good faith expenditures towards the clinical development of at
least one LICENSED PRODUCT, in a minimum amount of * dollars ($*), such
expenditures to be committed within five (5) years following the
EFFECTIVE DATE, or two (2) years following the receipt of GMP grade
Annamycin from a third party, whichever time period is shorter. Upon
written request, LICENSEE shall provide UTMDACC written documentation
of such expenditures at the conclusion of the applicable time period.
4.3 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;
(b) a list of LICENSED PRODUCTS produced for the three (3) preceding
calendar months categorized by the technology it relates to under
PATENT RIGHTS;
(c) the total quantities of LICENSED PRODUCTS produced by the category
listed in Section 4.3(b);
(d) the total SALES by the category listed in Section 4.3(b);
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(e) the calculation of NET SALES by the category listed in Section
4.3(b);
(f) the royalties so computed and due UTMDACC by the category listed
in Section 4.3(b);
(g) all consideration received from each sublicensee or assignee and
payments due UTMDACC; and
(h) all other amounts due UTMDACC herein.
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.
4.4 During the term of this AGREEMENT and for one year thereafter, LICENSEE
agrees to keep complete and accurate records of its and its
sublicensees' SALES and NET SALES and Section 4.2 expenditures in
sufficient detail to enable the royalties and other payments due
hereunder and LICENSEE's compliance with this AGREEMENT 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 ten percent (10%) of
the total amount due during the period so examined, then LICENSEE will
pay the cost of the examination plus accrued interest at eight percent
(8%) per annum or the maximum rate allowed by law, whichever is lower.
In the event that LICENSEE has overpaid any payment due UTMDACC,
UTMDACC will return any such overpayment to LICENSEE less demonstrable
costs of the audit.
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4.5 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.
4.6 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 United States mail to Box
297402, 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.).
4.7 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.
4.8 LICENSEE shall not be obligated to pay multiple royalties to UTMDACC
for a single LICENSED PRODUCT in the event said LICENSED PRODUCT is
covered by more than one patent application and/or patent that is (1)
included in the PATENT RIGHTS; and/or (2) directed to a XXXXXX
INVENTION. As used herein "XXXXXX INVENTION" shall mean an invention
that: (1) cannot be practiced without infringing a claim of an issued
patent or pending patent application under the PATENT RIGHTS, (2) is
made by Xx. Xxxxxxxx Xxxxxx or those working in his laboratory at
UTMDACC and under his direction while both are employed by UTMDACC; (3)
is conceived and reduced to practice within three (3) years of the
EFFECTIVE DATE; (4) directly relates to Anthracycline or related
DNA-binding agents, such as those exemplified by Annamycin, its
derivatives or analogs; (5) is limited to the LICENSED FIELD; and (6)
is not previously obligated to a third party, including, but not
limited to, any obligations to a third party under the ORIGINAL LICENSE
as amended by AMENDMENT NO. 6.
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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 After the EFFECTIVE DATE, with the exception of PATENT RIGHTS relating
to the ARONEX PATENT, Licensee will assume control and responsibility
for the filing, prosecution and maintenance of the PATENT RIGHTS,
including new applications and patent applications and patents existing
as of the EFFECTIVE DATE. Should a new patent application be necessary
to develop the LICENSED SUBJECT MATTER (other than LICENSED SUBJECT
MATTER covered by the ARONEX PATENT), LICENSEE will prepare and file
the appropriate patent applications, using an attorney or agent of
LICENSEE's choosing, subject to consent by UTMDACC, which consent shall
not be unreasonably withheld, and LICENSEE will pay the cost of
searching, preparing, filing, prosecuting and maintaining same.
LICENSEE shall promptly notify UTMDACC if it does not intend to pursue
any application or patent, including maintaining any existing patents.
If LICENSEE notifies UTMDACC that it does not intend to pursue any
application or patent, or if LICENSEE does not respond or make
reasonable efforts to agree with UTMDACC on the disposition of rights
of a subject invention, then UTMDACC may file such application or
pursue said patent at its own expense and LICENSEE's rights to such
invention under this AGREEMENT shall terminate in their entirety.
LICENSEE will provide UTMDACC with a copy of any application filed by
or on behalf of LICENSEE, as well as copies of any documents received
or filed by or on behalf of LICENSEE during prosecution of any patents
or patent applications covered by PATENT RIGHTS. The parties agree that
they share a common legal interest to get valid enforceable patents and
that UTMDACC and LICENSEE will keep all privileged information received
pursuant to this Section confidential. UTMDACC agrees to provide all
information in its possession (including but not limited to data,
reports or memoranda) reasonably necessary to LICENSEE for the
prosecution of any current or future patent application related to the
LICENSED SUBJECT MATTER. As between LICENSEE, BOARD and UTMDACC, BOARD
and UTMDACC shall have full and complete control over filing,
prosecution, maintenance and all other patenting matters relating to
the ARONEX PATENT.
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VII. INFRINGEMENT BY THIRD PARTIES
7.1 Except for the ARONEX PATENT, LICENSEE, at its discretion and expense,
may enforce any patent exclusively licensed hereunder against any
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 ten percent (10%) of any recovery (including punitive damages)
awarded for patent infringement. LICENSEE must notify UTMDACC in
writing of any potential infringement within sixty (60) calendar days
of knowledge thereof. If LICENSEE does not file suit against a
substantial infringer within six (6) months of knowledge thereof, then
BOARD or UTMDACC may, at its sole discretion and expense, enforce any
patent licensed hereunder on behalf of itself and LICENSEE, with
UTMDACC retaining all recoveries from such enforcement and/or reduce
the license granted hereunder to non-exclusive with respect to the
patent(s) at issue. The provisions of this Section 7.1 shall not apply
to the ARONEX PATENT, and as between LICENSEE, BOARD and UTMDACC, BOARD
and UTMDACC shall have complete control over all infringement matters
and actions relating to the ARONEX PATENT and the right to retain any
recoveries therefrom
7.2 In any suit or dispute involving an allegation of infringement, 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.
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VIII. PATENT MARKING
8.1 LICENSEE agrees to use reasonable efforts to xxxx 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, LICENSED PRODUCTS 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.
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 by LICENSEE, its officers, its AFFILIATES or their
officers, employees, agents or representatives, of the rights granted
hereunder; provided, however, that the following is excluded from
LICENSEE's obligation to indemnify and hold harmless:
(a) the negligent failure of UTMDACC to substantially comply with any
applicable governmental requirements; and
(b) the negligence or willful malfeasance by a Regent, officer, agent
or employee of UTMDACC or System.
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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. The total aggregate liability of BOARD,
SYSTEM and UTMDACC for all damages of any kind relating to this
AGREEMENT or its subject matter shall not exceed the amounts paid by
LICENSEE to BOARD or UTMDACC under this AGREEMENT during the one (1)
year period preceding the date of the event that gave rise to the
liability. The foregoing exclusions and limitations shall apply to all
claims and actions of any kind, whether based on contract, tort
(including, but not limited to, negligence), or any other grounds.
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 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.
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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:
M. D. Xxxxxxxx Services Corporation
0000 X. Xxxx, Xxxxx 000, Xxxx 0000
Xxxxxxx, XX 00000
ATTENTION: Xxxxxxx Xxxxxx
Email: xxxxxxx@xxxxxxxxxx.xxx
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.
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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) 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 by 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 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 own confidential
information, but always at least a reasonable degree of care. The
obligation of confidence shall remain in force throughout the term of
this AGREEMENT and for a period of five (5) years thereafter.
11.3 Either party may disclose to the relevant Patent Office personnel
confidential information of the other party, necessary for the purpose
of advancing the prosecution of PATENT RIGHTS relating to the LICENSED
SUBJECT MATTER, provided however, that the disclosing party will inform
the non-disclosing party of the intention to disclose and the nature of
the confidential information to be disclosed prior to making such
disclosure and the non-disclosing party will, to the extent possible,
be given an opportunity to suggest an alternative to the disclosure.
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11.4 Notwithstanding any other provision herein to the contrary, 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 ninety
(90) calendar days in advance of submission for 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 one hundred
twenty (120) 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.
11.5 As indicated in AMENDMENT NO. 6, EXCERPTS of which are attached hereto
as Exhibit II, BOARD and UTMDACC are obtaining certain Returned
Technology Information (as defined in Paragraph II. J. 1. of AMENDMENT
NO. 6) from ARONEX PHARMACEUTICALS, INC. Upon request, said Returned
Technology Information will be made available to LICENSEE at LICENSEE's
expense. In the event Returned Technology Information is subsequently
disclosed to LICENSEE in connection with this AGREEMENT, LICENSEE
covenants and agrees, in addition to its other obligations hereunder:
(a) to maintain the Returned Technology Information in confidence and
not use or disclose it except for the purposes, and subject to the
limitations, set forth in subparagraphs II.J.2 (a)-(b) of
AMENDMENT NO. 6;
(b) to indemnify and hold ARONEX PHARMACEUTICALS, INC. and its
directors, officers, employees, agents and Subsidiaries harmless
against any Losses arising out of any use or disclosure of the
Returned Technology Information by the LICENSEE or by any person
or entity to which the LICENSEE has disclosed or transferred the
Returned Technology Information;
(c) to comply with the requirements set forth in subsection II.J.4 and
5 of AMENDMENT NO. 6 for any Documents in its possession;
(d) that ARONEX PHARMACEUTICALS, INC. is a third party beneficiary of
provisions II.J.6.(A), (B), and (C) of AMENDMENT NO. 6, with the
authority to enforce the provisions against the LICENSEE; and
(e) that LICENSEE shall treat Exhibit II both as Returned Technology
Information under AMENDMENT NO. 6 and as confidential information
under this AGREEMENT.
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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 13.2, 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 five (5) years from the EFFECTIVE DATE, BOARD or UTMDACC
have the right to terminate this license in any national political
jurisdiction within the LICENSED TERRITORY if LICENSEE, within ninety
(90) calendar days after receiving written notice from UTMDACC of the
intended termination, fails to provide written evidence which shows,
given the totality of the circumstances, that LICENSEE or its
sublicensee(s) has commercialized or is actively and effectively
attempting to commercialize a licensed invention in such
jurisdiction(s), provided, however, that UTMDACC shall not send more
than one (1) such written notice in any six (6) month period. The
following definitions apply to Section 13.2: (a) "commercialized" means
having SALES in such jurisdiction, and (b) "actively and effectively
attempting to commercialize" means having, either directly or
indirectly, 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 describing such attempts to
UTMDACC to commercialize licensed inventions in the jurisdiction(s)
that UTMDACC intends to terminate.
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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;
(b) upon ninety (90) 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 ninety (90) calendar day notice period,
LICENSEE has cured the default or breach to UTMDACC's reasonable
satisfaction, and so notifies UTMDACC, stating the manner of the
cure;
(c) upon thirty (30) calendar days written notice from UTMDACC, if
LICENSEE fails to make the good faith expenditures detailed in
Section 4.2 within the prescribed time period;
(d) 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 reasonable satisfaction and so notifies
UTMDACC, stating the manner of the cure;
(e) at any time by mutual written agreement between LICENSEE and
UTMDACC subject to any terms herein which survive termination;
(f) if Section 13.2 is invoked;
(g) if LICENSEE has defaulted or been in excess of one (1) month late
on its payment obligations pursuant to the terms of this AGREEMENT
on any two (2) occasions in a twelve (12) month period, provided
however, that LICENSEE shall have fourteen (14) days from
receiving written notice from UTMDACC of the second default or
late payment to cure the default or late payment to the reasonable
satisfaction of UTMDACC, and so notifies UTMDACC, stating the
manner of cure;
(h) upon one hundred twenty (120) calendar days written notice from
LICENSEE, LICENSEE may terminate its obligations to make payments
under this AGREEMENT solely with respect to a particular patent or
patents included in PATENT RIGHTS, if such particular patent or
patents is or are irrevocably adjudicated to be invalid or
otherwise unenforceable;
(i) upon one hundred twenty (120) calendar days written notice from
LICENSEE if any particular patent or patents included in the
PATENT RIGHTS and which account for at least thirty (30%) percent
of the total royalty to UTMDACC pursuant to Article 4.1(c), is or
are irrevocably adjudicated to be invalid or otherwise
unenforceable; or
(j) upon ninety (90) calendar days written notice from LICENSEE if
BOARD is in breach of Article 14.1 (Confidential Information and
Publication) unless, before the end of the such ninety (90)
calendar-day notice period, UTMDACC has cured the default or
breach to LICENSEE's reasonable satisfaction and so notifies
LICENSEE, stating the manner of the cure.
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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;
(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;
(c) UTMDACC and BOARD agree to be bound by Article XI;
(d) 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;
(e) Subject to Section 13.4(d), 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
(f) 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 LICENSED PRODUCTS.
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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 provided in Section 14.3,
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 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.
14.3 LICENSEE understands and agrees that BOARD and/or UTMDACC previously
licensed the PATENT RIGHTS and LICENSED SUBJECT MATTER to ARGUS, and
that certain rights thereto were returned to the BOARD pursuant to
AMENDMENT NO. 6, EXCERPTS of which are attached hereto as Exhibit II.
LICENSEE understands and agrees that LICENSEE's rights under this
AGREEMENT are subject to the terms and conditions of AMENDMENT NO. 6,
and that in the event of any conflict between this AGREEMENT and
AMENDMENT XX. 0, XXXXXXXXX XX. 0 shall control. Nothwithstanding any
other provision herein to the contrary, LICENSEE understands and agrees
that with respect to the ARONEX PATENT and/or U.S. Application No.
09/122,427, described in Section 11 of AMENDMENT NO. 6, BOARD's rights
to the subject matter thereof and thus the rights granted to LICENSEE
under this AGREEMENT are limited in scope as set forth in Section 11.
The license granted to LICENSEE in Article III of this AGREEMENT is
expressly limited to the BOARD's licensing rights under Section 11,
including, but not limited to, the restrictions on use solely in the
Anthracycline Field, as set forth in Section 11 of AMENDMENT NO. 6.
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14.4 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 do BOARD and UTMDACC make any representation that the
inventions contained in PATENT RIGHTS and/or LICENSED SUBJECT MATTER do
not infringe any other patents now held or that will be held by others
or by BOARD.
14.5 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 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
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:
The University of Texas 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: Dr. Xxxx Xxxxxx, CEO
FAX: (000) 000-0000
or other addresses as may be given from time to time under the terms of
this notice provision.
15.3 The Parties agree to 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 Nothing in this AGREEMENT shall be deemed as a waiver by BOARD, SYSTEM
or UTMDACC of its sovereign immunity.
15.5 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.
15.6 Headings included herein are for convenience only and will not be used
to construe this AGREEMENT.
15.7 BOARD and/or UTMDACC may disclose an executed copy of this AGREEMENT,
in confidence, to ARONEX PHARMACEUTICALS, INC.
15.8 If any part of this AGREEMENT is for any reason found to be
unenforceable, all other parts nevertheless will remain enforceable.
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IN WITNESS WHEREOF, the parties hereto have caused their duly
authorized representatives to execute this AGREEMENT.
BOARD OF REGENTS OF THE CALLISTO PHARMACEUTICALS, INC.
UNIVERSITY OF TEXAS SYSTEM
By /s/ Xxxx Xxxxxxxxxx, M.D. By /s/ Xxxx Xxxxx
------------------------- --------------
Xxxx Xxxxxxxxxx, M.D. Dr. Xxxx Xxxxxx
President Chief Executive Officer
The University of Texas Callisto Pharmaceuticals, Inc.
M. D. Xxxxxxxx Cancer Center
Date: 8/12/04 Date: 7/20/04
------- -------
THE UNIVERSITY OF TEXAS
M. D. XXXXXXXX CANCER CENTER
By /s/ Xxxx Xxxxx
--------------
Xxxx Xxxxx
Executive Vice President
The University of Texas
M. D. Xxxxxxxx Cancer Center
Date: 8/11/04
Approved as to Content:
By /s/ Xxxxxxx X. Xxxx
-------------------
Xxxxxxx X. Xxxx
Managing Director, Technology
Commercialization
M. D. Xxxxxxxx Cancer Center
Date: 7/22/04
Approved as to form /s/ Xxxx Xxxxxxxx
-----------------
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