Exhibit 10.3
PATENT AND TECHNOLOGY LICENSE
AGREEMENT
This thirty (30) page AGREEMENT ("AGREEMENT") is
made on this 21 st 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 201 West 7th
Street, Austin, Texas 78701, on behalf of THE UNIVERSITY OF TEXAS
M. D. ANDERSON CANCER CENTER ("UTMDACC"), a component institution
of SYSTEM, and SIGNPATH PHARMACEUTICALS, INC., a Delaware
corporation having a principal place of business located at 45
Broadway, 2 nd Floor, New York, New York 10006
("LICENSEE").
RECITALS
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BOARD owns
certain PATENT RIGHTS and TECHNOLOGY RIGHTS related to LICENSED
SUBJECT MATTER developed at UTMDACC.
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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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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
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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:
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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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LICENSED
FIELD means human and
animal use.
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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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LICENSED
SUBJECT MATTER means
inventions and discoveries covered by PATENT RIGHTS or TECHNOLOGY
RIGHTS within the LICENSED FIELD.
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LICENSED
TERRITORY means
worldwide.
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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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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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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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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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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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REGULATORY
APPROVAL means the FDA
approval necessary for the SALE of a LICENSED PRODUCT in the United
States.
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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 Dr. Razelle Kurzrock, 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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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
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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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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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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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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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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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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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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
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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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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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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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Nonrefundable
Annual Maintenance Fees and Minimum Annual Royalties due and
payable according to the following schedule:
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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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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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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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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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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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A running
royalty as follows:
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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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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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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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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
(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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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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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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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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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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a list of
LICENSED PRODUCTS produced by LICENS
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