PATENT AND TECHNOLOGY LICENSE AGREEMENT
Exhibit
10.3
This
thirty (30) page AGREEMENT ("AGREEMENT") is made on this 21st day of
February, 2007, 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
SIGNPATH PHARMACEUTICALS, INC., a Delaware corporation having a principal place
of business located at 00 Xxxxxxxx, 0xx Xxxxx,
Xxx Xxxx, Xxx Xxxx 00000 ("LICENSEE").
RECITALS
A.
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BOARD
owns certain PATENT RIGHTS and TECHNOLOGY RIGHTS related to LICENSED
SUBJECT MATTER developed at
UTMDACC.
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B.
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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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C.
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LICENSEE
wishes to obtain a license from BOARD to practice LICENSED SUBJECT
MATTER.
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NOW,
THEREFORE, in consideration of the mutual covenants and promises herein
contained, the parties agree as follows:
I. EFFECTIVE
DATE
1.1
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This
AGREEMENT is effective as of the date written above ("EFFECTIVE DATE"),
which is the date fully executed by all
parties.
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II. DEFINITIONS
As used
in this AGREEMENT, the following terms have the meanings indicated:
2.1
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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.
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2.2
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LICENSED FIELD means
human and animal use.
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2.3
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LICENSED PRODUCTS means
any product or service sold by LICENSEE, its AFFILIATES or its
sublicensees comprising LICENSED SUBJECT MATTER pursuant to this
AGREEMENT.
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2.4
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LICENSED SUBJECT MATTER
means inventions and discoveries covered by PATENT RIGHTS or TECHNOLOGY
RIGHTS within the LICENSED FIELD.
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2.5
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LICENSED TERRITORY means
worldwide.
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2
2.6
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NET SALES means the
gross revenues received by LICENSEE, its AFFILIATES, or its sublicensees
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. In the event of a SALE of a COMBINATION PRODUCT,
the parties shall work together in good faith to determine what portion of
resulting gross revenues shall be used for determining NET SALES based on
the value added to the price of such COMBINATION PRODUCT by LICENSED
SUBJECT MATTER relative to value added by other therapeutically active
ingredients or other proprietary technology or information. For
purposes of this Section 2.6, the term "COMBINATION PRODUCT" means any
LICENSED PRODUCT that contains at least one other therapeutically active
ingredient or, in the case of a service, at least one other proprietary
technology.
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2.7
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PATENT RIGHTS means
BOARD's rights in the information or discoveries described in invention
disclosures, or claimed in any patents and/or patent applications, whether
domestic or foreign, as identified in Exhibit I attached hereto, and all
divisionals, continuations, continuations-in-part (to the extent the
claims of such continuations-in-part are entitled to claim priority to the
aforesaid patents and/or patent applications identified in Exhibit I),
reissues, reexaminations or extensions of the patents and/or patent
applications identified in Exhibit I, and any letters patent, domestic or
foreign that issue thereon.
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2.8
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PHASE 1 STUDY means: (a)
that portion of the drug development and review process which provides for
the initial introduction of an investigational new drug into human
subjects, as more specifically defined by the rules and regulations of the
FDA, including 21 C.F.R. § 312.21 or
any future revisions or substitutes therefor; or (b) a similar clinical
trial in any national jurisdiction other than the United
States.
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2.9
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PHASE 2 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, including 21 C.F.R. § 312.21 or
any future revisions or substitutes therefor; or (b) a similar clinical
trial in any national jurisdiction other than the United
States.
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2.10
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PHASE 3 STUDY means (a)
that portion of the drug development and review process in which expanded
clinical studies are conducted to gather the additional information about
effectiveness and safety that is needed to evaluate the overall
benefit-risk relationship of an investigational new drug, as more
specifically defined by the rules and regulations of the FDA, including 21
C.F.R.
§ 312.21 or any future revisions or substitutes therefor; or (b) a
similar clinical trial in any national jurisdiction other than the United
States.
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2.11
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REGULATORY APPROVAL means the FDA
approval necessary for the SALE of a LICENSED PRODUCT in the United
States.
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2.12
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SALE or SOLD means the
transfer or disposition of a LICENSED PRODUCT for value to a party other
than LICENSEE, an AFFILIATE or a ROYALTY-FREE PRACTITIONER. As
used herein, "ROYALTY-FREE PRACTITIONER" means UTMDACC and Xx. Xxxxxxx
Xxxxxxxx, M.D. ("PHYSICIAN INVENTOR"), and any partner or associate who
practices medicine with the PHYSICIAN INVENTOR, but with respect to such
partner or associate, only for such time as they are engaged in a bona
fide medical practice with the PHYSICIAN
INVENTOR.
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2.13
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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.
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III. LICENSE
3.1
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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 AGREEMENT, and is further subject to the
following rights retained by BOARD and UTMDACC
to:
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(a)
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Publish
the general scientific findings from research related to LICENSED SUBJECT
MATTER, subject to the terms of ARTICLE XI–Confidential Information and
Publication; and
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(b)
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Use
LICENSED SUBJECT MATTER for non-commercial research, non-commercial
patient care, teaching and other educationally-related
purposes. Use of LICENSED SUBJECT MATTER in clinical trials and
other research involving patients shall be considered non-commercial
research or non-commercial patient care provided that BOARD and UTMDACC do
not sell such LICENSED SUBJECT MATTER to said
patients.
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3.2
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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.
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3.3
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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.
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3.4
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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
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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.
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IV. CONSIDERATION,
PAYMENTS AND REPORTS
4.1
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In
consideration of rights granted by BOARD to LICENSEE under this AGREEMENT,
LICENSEE agrees to pay UTMDACC the
following:
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(a)
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All
reasonable 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 after the
AGREEMENT has been fully executed by all parties 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
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(b)
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A
nonrefundable license documentation fee in the amount of fifteen thousand
dollars ($15,000). 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; and
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(c)
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Nonrefundable
Annual Maintenance Fees and Minimum Annual Royalties due and payable
according to the following
schedule:
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(1)
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An
Annual Maintenance Fee of ten thousand dollars ($10,000), due and payable
within thirty (30) calendar days of the first anniversary of the EFFECTIVE
DATE and every anniversary occurring thereafter until: (i) the seventh
anniversary of the EFFECTIVE DATE; (ii) the first SALE; or (iii) issuance
of a patent for any PATENT RIGHTS ("PATENT"), whichever comes first;
and
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(2)
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An
Annual Maintenance Fee of thirty thousand dollars ($30,000), due and
payable within thirty (30) calendar days of the
seventh anniversary of the EFFECTIVE DATE and every anniversary
occurring thereafter until the first SALE, subject to Sections
4.1(c)(3)-(4), below;
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(3)
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Subject
to Section 4.1(c)(4), below, if a PATENT issues prior to the first SALE or
the seventh anniversary of the EFFECTIVE DATE, the Annual Maintenance Fee
shall be increased from ten thousand dollars ($10,000) to fifteen thousand
dollars ($15,000) per year, due and payable on the anniversary of the
EFFECTIVE DATE immediately following issuance of the PATENT and every
anniversary occurring thereafter until: (i) the first SALE; or (ii) the
seventh anniversary of the EFFECTIVE DATE, whichever comes
first;
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(4)
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Notwithstanding
any provision in Sections 4.1(c)(1)-(3) to the contrary, upon the first
SALE, the Annual Maintenance Fee shall be converted to a Minimum Annual
Royalty of seventy-five thousand dollars ($75,000), due and
payable within thirty (30) calendar days of the anniversary of the
EFFECTIVE DATE immediately following the first SALE, and every anniversary
occurring thereafter;
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(5)
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Running
royalties accrued under Section 4.1(d) and paid to UTMDACC during the one
year period preceding an anniversary of the EFFECTIVE DATE may be credited
against the Minimum Annual Royalty due on that anniversary date;
and
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(d)
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A
running royalty as follows:
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(1)
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two
and one half percent (2.5%) of NET SALES less than $250 million for
LICENSED PRODUCTS covered by an issued
patent;
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(2)
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three
percent (3%) of NET SALES equal to or greater than $250 million for
LICENSED PRODUCTS covered by an issued patent;
and
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(3)
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one
and one half percent (1.5%) of NET SALES of LICENSED PRODUCTS not covered
by an issued patent.
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If
LICENSEE is obligated to pay running royalties to a third party to avoid
infringing such third party’s patent rights which dominate BOARD'S PATENT RIGHTS
(as documented by a written opinion of an independent, qualified patent
attorney, a copy of which is provided to BOARD), LICENSEE may reduce the running
royalty due UTMDACC by one half of the running royalty rate being paid to such
third party, provided, however, the running royalty rate due UTMDACC will not be
reduced to less than two percent (2%) of NET SALES of LICENSED PRODUCTS covered
by an issued patent or one percent (1%) of NET SALES of LICENSED PRODUCTS not
covered by an issued patent; and
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(e)
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The
following one-time milestone payments, regardless of whether the milestone
is achieved by LICENSEE, a sublicensee or AFFILIATE, or, in the case of
milestone 4.1(e)(5), by any of the foregoing, BOARD and/or
UTMDACC
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(1)
Ten thousand dollars ($10,000) upon dosing the first patient with a LICENSED
PRODUCT in a PHASE 1 STUDY;
(2)
Twenty-five thousand dollars ($25,000) upon dosing the first patient with a
LICENSED PRODUCT in a PHASE 2 STUDY;
(3)
Fifty thousand dollars ($50,000) upon dosing the first patient with a LICENSED
PRODUCT in a PHASE 3 STUDY, provided that, if no PATENT has issued at the time
this milestone is achieved, the amount of the milestone shall be reduced from
fifty thousand dollars ($50,000) to forty thousand dollars
($40,000);
(4)
Four hundred thousand dollars ($400,000) upon the first REGULATORY APPROVAL of a
LICENSED PRODUCT, provided that, if no PATENT has issued at the time this
milestone is achieved, the amount of the milestone shall be reduced from four
hundred thousand dollars ($400,000) to two hundred thousand dollars ($200,000);
and
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(5)
Fifteen thousand dollars ($15,000) upon issuance of a PATENT.
Each of
the foregoing milestone payments shall be made by LICENSEE to UTMDACC (without
invoice) within thirty (30) calendar days of achieving the milestone event and
shall not reduce the amount of any other payment provided for in this ARTICLE
IV; and
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(f)
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The
following percentages of all non-royalty consideration received by
LICENSEE from any sublicensee pursuant to Sections 3.3 and 3.4
hereinabove, including but not limited to, up-front payments, marketing,
distribution, franchise, option, license, or documentation fees, research
and development money, bonus and milestone payments and equity
securities:
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(1)
twenty-five percent (25%) of all non-royalty consideration if the sublicense is
executed before the third anniversary of the EFFECTIVE DATE; and
(2)
twenty percent (20%) of all non-royalty consideration if the sublicense is
executed on or after the third anniversary of the EFFECTIVE DATE;
and
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(g)
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This
AGREEMENT may be assigned in accordance with the provisions of Section
12.1 subject to the payment to UTMDACC of a one hundred thousand dollar
($100,000) assignment fee prior to the assignment. In the event the
assignment fee is not paid prior to the assignment, said assignment shall
be void.
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4.2
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Unless
otherwise provided, all such payments are payable quarterly within thirty
(30) days after finalization of the financial statements for the quarters
ended March 31, June 30, September 30, and December 31 of each year during
the term of this AGREEMENT or within sixty (60) days after March 31, June
30, September 30, and December 31 of each year during the term of this
AGREEMENT (whichever is earlier), at which time LICENSEE will also deliver
to UTMDACC a true and accurate report, giving such particulars of the
business conducted by LICENSEE, its AFFILIATES and its sublicensees, if
any exist, during the preceding three (3) 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:
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(a)
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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, its AFFILIATES and
sublicensees since the previous report;
and
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(b)
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a
list of LICENSED PRODUCTS produced by LICENSEE, its AFFILIATES and
sublicensees for the three (3) preceding calendar months;
and
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(c)
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the
total quantities of LICENSED PRODUCTS produced by LICENSEE, its AFFILIATES
and sublicensees; and
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(d)
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the
total SALES by LICENSEE, its AFFILIATES and sublicensees;
and
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(e)
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the
calculation of NET SALES; and
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(f)
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the
royalties so computed and due UTMDACC and/or minimum
royalties; and
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(g)
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all
consideration received from each sublicensee or assignee and payments due
UTMDACC; and
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(h)
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all
other amounts due UTMDACC herein.
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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
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During
the term of this AGREEMENT and for one (1) year thereafter, LICENSEE
agrees to keep complete and accurate records of its, its AFFILIATES' 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 upon reasonable notice 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 lesser of: (1) the highest allowable rate; or
(2) the prime rate plus two
percent.
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4.4
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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.
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4.5
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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: Grants and Contracts or by wire
transfer to:
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JPMorgan
Chase Bank, N.A.
000
Xxxxxx
Xxxxxxx,
Xxxxx 00000
SWIFT: XXXXXX00
(for international wires only)
ABA
ROUTING NO: 000000000
ACCOUNT
NAME: Univ. of
Texas X. X. 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
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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.
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V. IND AND
SPONSORED RESEARCH
5.1
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LICENSEE shall use best efforts to file an
Investigational New Drug Application ("IND") with
the FDA for a LICENSED PRODUCT containing liposomal curcumin within two
(2) years of the EFFECTIVE DATE.
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5.2
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In addition to the consideration set forth in
ARTICLE IV, LICENSEE shall provide funding for the completion of all
preclinical studies necessary to file an IND on a
LICENSED PRODUCT containing liposomal curcumin, and shall fund at least
$250,000.00 towards such preclinical studies. Of the
$250,000 funding obligation, at least $100,000 shall be funded within six
months of the EFFECTIVE DATE, and an aggregate total of at least $200,000
shall be funded within one year of the EFFECTIVE
DATE.
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5.3
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If
LICENSEE desires to sponsor
additional 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) will solicit research
and/or clinical proposals from UTMDACC for this purpose, and (c) will give
good faith consideration to funding the proposals at
UTMDACC.
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VI. PATENTS
AND INVENTIONS
6.1
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If
after consultation with LICENSEE both parties agree that a new patent
application should be filed for LICENSED SUBJECT MATTER, UTMDACC will
prepare and file appropriate patent applications, and LICENSEE will pay
the reasonable cost of searching, preparing, filing, prosecuting and
maintaining same. 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. UTMDACC will provide LICENSEE with
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. 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.
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VII. INFRINGEMENT
BY THIRD PARTIES
7.1
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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 related punitive damages; or (b)
fifty percent (50%) of reasonable royalties awarded and related punitive
damages in any monetary 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 does not file suit against or enter into a
sublicense with a substantial infringer within six (6) months of knowledge
thereof, then BOARD or UTMDACC may, at its sole discretion, 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.
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7.2
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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.
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VIII. PATENT
MARKING
8.1
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LICENSEE
agrees that all packaging containing individual LICENSED PRODUCT(S),
documentation therefor, and, when possible, 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.
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IX. INDEMNIFICATION
AND INSURANCE
9.1
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LICENSEE
agrees to hold harmless and indemnify BOARD, SYSTEM, UTMDACC, their
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.
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9.2
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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.
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9.3
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Beginning
at the time when any LICENSED SUBJECT MATTER is being distributed or sold
(including for the purpose of obtaining regulatory approvals) by LICENSEE,
an AFFILIATE, or by a sublicensee, LICENSEE shall, at its sole cost and
expense, procure and maintain commercial general liability insurance in
amounts not less than two million dollars ($2,000,000) per incident and
two million dollars ($2,000,000) annual aggregate, and LICENSEE shall use
reasonable efforts to have the BOARD, SYSTEM, UTMDACC, their 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.
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9.4
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LICENSEE
shall provide UTMDACC with written evidence of such insurance within
thirty (30) calendar days of its procurement. Additionally,
LICENSEE shall provide UTMDACC with written notice of at least fifteen
(15) calendar days prior to the cancellation, non-renewal or material
change in such insurance.
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9.5
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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, an AFFILIATE or by a
sublicensee or agent of LICENSEE; and (ii) the two (2) year period
immediately after such period.
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X. USE
OF BOARD AND UTMDACC’S NAME
10.1
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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:
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The
University of Texas
M. D.
Xxxxxxxx Cancer Center
Legal
Services, Xxxx 0000
X.X. Xxx
000000
Xxxxxxx,
XX 00000-0000
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.
19
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 disclosing 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
disclosing party’s confidential information;
or
|
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(f)
|
is
required by law or regulation to be
disclosed.
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11.2
|
Each
party’s obligation of confidence hereunder will be fulfilled by using at
least the same degree of care with the disclosing party's confidential
information as it uses to protect its 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.
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20
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 substantially 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 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 fifteen (15) years. If no
PATENT has issued and a LICENSED PRODUCT receives REGULATORY APPROVAL
prior to the end of the term set forth in this Section 13.1, and the
AGREEMENT has not otherwise terminated or expired, then the term shall be
automatically extended until fifteen (15) years past regulatory approval
of the LICENSED PRODUCT.
|
21
13.2
|
Any
time after the third anniversary of 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 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) "commercialized" means having SALES in such jurisdiction; and
(b) "actively and effectively attempting to commercialize" means having an
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.
|
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
|
22
|
(c)
|
upon thirty (30) calendar days written notice from
UTMDACC, if LICENSEE fails to fund completion of preclinical studies or
file an IND, as provided in ARTICLE V, 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
|
|
(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 satisfaction and so notifies
UTMDACC, stating the manner of the cure;
or
|
|
(e)
|
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
|
|
(f)
|
if
Section 13.2 is invoked.
|
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
|
23
|
(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, for a period of one year 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
|
|
(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.
|
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, 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
("Government") and, if so, that the Government may have certain rights
relative thereto. This AGREEMENT is explicitly made subject to
the Government's rights under any such agreement and any applicable law or
regulation. 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.
|
24
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 do 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 expertise, or has used knowledgeable and expert consultants,
to adequately conduct such due diligence, and agrees to accept all risks
inherent herein.
|
25
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:
Xxxxxxxxxxx X. Xxxxxxx, M.D.
or in the
case of LICENSEE to:
SIGNPATH
PHARMACEUTICALS, INC.
c/x Xxxxx
Associates
00
Xxxxxxxx
0xx
Xxxxx
Xxx Xxxx,
Xxx Xxxx 00000
ATTENTION: Xxxxx
Xxxxx
or other
addresses as may be given from time to time under the terms of this notice
provision.
26
15.3
|
LICENSEE
must comply with all applicable federal, state and local laws and
regulations in connection with its activities pursuant to this AGREEMENT.
LICENSEE acknowledges that the LICENSED SUBJECT MATTER is subject to U. S.
export control jurisdiction. LICENSEE agrees to comply with all
applicable international and national laws that apply to the LICENSED
SUBJECT MATTER, including U.S. Export Administration Regulations, as well
as end-user, end-use, and destination restrictions applied by the United
States.
|
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 in this AGREEMENT shall be deemed as a waiver by BOARD,
SYSTEM or UTMDACC of its sovereign
immunity.
|
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.
|
27
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.
|
28
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
|
SIGNPATH
PHARMACEUTICALS, INC.
|
|||||
By
|
/s/ Xxxx Xxxxxxxxxx
|
By
|
/s/ Xxxxx Xxxxxx
|
|||
Xxxx
Xxxxxxxxxx, M.D.
|
Xxxxx
Xxxxxx
|
|||||
President
|
Acting
President
|
|||||
The
University of Texas
|
||||||
M.
D. Xxxxxxxx Cancer Center
|
||||||
Date:
|
2/21/07
|
Date:
|
1/26/07
|
|||
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:
|
2/16/07
|
|||||
Approved
as to Content:
|
||||||
By
|
/s/ Xxxxxxxxxxx X. Xxxxxxx
|
|||||
|
Xxxxxxxxxxx X.
Xxxxxxx, M.D.
|
|||||
Vice
President, Technology Transfer
|
||||||
M.
D. Xxxxxxxx Cancer Center
|
||||||
Date:
|
2/5/07
|
29
EXHIBIT
I
MDA03-001,
"Liposomal Curcumin for treatment of Cancer," Inventors Xxxxxxx Xxxxxxxx, M.D.,
Xxx Xx, Xxxxx Xxxxx, Ph.D., Xxxxxx X. Xxxxxxxx, Ph.D.
30