PATENT AND TECHNOLOGY LICENSE AGREEMENT
Exhibit
10.9
This
thirty-four (34) page AGREEMENT ("AGREEMENT") is made on this 18th day
of August, 2008, by and between THE UNIVERSITY OF NORTH TEXAS HEALTH SCIENCE
CENTER at FORT WORTH (UNTHSC), a State of Texas institution of higher
education, whose address is 0000 Xxxx Xxxxx Xxxx. Xxxx Xxxxx, Xxxxx 00000-0000,
and SIGNPATH PHARMACEUTICALS, INC., a Delaware corporation having a principal
place of business located at 00 Xxxxxxxx, 0xx Xxxxx
Xxx Xxxx, XX 00000 ("LICENSEE").
RECITALS
A.
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UNTHSC
owns certain PATENT RIGHTS and TECHNOLOGY RIGHTS related to LICENSED
SUBJECT MATTER developed at UNTHSC.
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B.
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UNTHSC
desires to have the LICENSED SUBJECT MATTER developed in the LICENSED
FIELD and used for the benefit of LICENSEE, UNTHSC, the
inventor(s), and the public as outlined in UNTHSC's Intellectual Property
Policy.
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C.
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LICENSEE
wishes to obtain a license from UNTHSC 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:
1
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
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As
used in this AGREEMENT, the following terms have the meanings
indicated:
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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 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
UNTHSC's rights in the information or discoveries described in invention
disclosures, or claimed in patents and/or patent applications, whether
domestic or foreign, as identified in Exhibit 1 attached hereto, and all
divisional, continuations, continuations-in-part (to the extent
claims of such continuations-in-part are entitled to claim priority to the
aforesaid patents and/or patent applications identified in Exhibit 1),
reissues, reexaminations, or extensions of the patents and/or
patent applications identified in Exhibit 1, and any letters patent,
domestic or foreign that issue
thereon.
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2.8
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PHASE I
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 investigational new drug for 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 or an AFFILIATE.
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2.13
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TECHNOLOGY RIGHTS means UNTHSC'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
1 before the EFFECTIVE DATE, whether or not they are claimed in
PATENT RIGHTS but that are necessary for practicing PATENT
RIGHTS.
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2.14
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IMPROVEMENT PATENTS
means patents and patent applications covering inventions in the
LICENSED FIELD that are (i) conceived at UNTHSC by any of the inventors of
the Patent Rights within two and a half years of the EFFECTIVE DATE,
the making, use, sale, importation or other practice of which would
infringe one or more pending or issued claims of the then-existing
LICENSED SUBJECT MATTER, and (ii) owned or controlled by UNTHSC and not
subject to any pre-existing third party
obligations.
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III.
LICENSE
3.1
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UNTHSC 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 PRODDUCTS 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 UNTHSC of all consideration
as provided herein, the timely payment of all amounts due under any
related sponsored research agreement between UNTHSC and LICENSEE
in effect during this AGREEMENT, and is further subject to
the following rights retained by UNTHSC
to:
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5
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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
LICENSED SUBJECT MATTER in clinical trials and other research involving
patients shall be considered non-commercial research or non-commercial
patient care provided that UNTHSC does 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 or assign this AGREEMENT 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 UNTHSC 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 UNTHSC 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, UNTHSC agrees 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 rights granted by UNTHSC to LICENSEE under this AGREEMENT,
LICENSEE agrees to pay UNTHSC the
following:
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(a)
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All
reasonable out-of-pocket expenses incurred by UNTHSC in filing,
prosecuting, enforcing and maintaining PATENT RIGHTS (which, as of the
EFFECTIVE DATE are estimated to be $12,034), and all such reasonable
future expenses incurred by UNTHSC, for so long as, and in such countries
as this AGREEMENT remains in effect. On the six-month anniversary of the
EFFECTIVE DATE, UNTHSC will invoice LICENSEE 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 UNTHSC; 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”) as set forth in (3) below,
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 Sections 4.1(c)(4), below, if a United States PATENT issues, or a
European Patent issues (and is not challenged within the statutory
challenge period) 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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8
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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 within thirty
(30) calendar days of the anniversary of the EFFECTIVE DATE immediately
following the first SALE, and every anniversary reoccurring
thereafter;
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(5)
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Running
royalties accrued under Section 4.1(d) and paid to UNTHSC 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 and 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 UNTHSC'S PATENT
RIGHTS (as documented by a written opinion of an independent, qualified patent
attorney, a copy of which is provided to UNTHSC), LICENSEE may reduce the
running royalty due UNTHSC by one half of the running royalty rate being paid to
such third party, provided, however, the running royalty rate due UNTHSC 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 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, and/or
UNTHSC.
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(1)
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Ten
thousand dollars ($10,000) upon dosing the first patient with a LICENSED
PRODUCT in each PHASE 1 STUDY;
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(2)
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Twenty-five
thousand dollars ($25,000) upon dosing the first patient with a LICENSED
PRODUCT in each PHASE 2 STUDY;
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(3)
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Fifty
thousand ($50,000) upon dosing the first patient with a LICENSED PRODUCT
in each 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);
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(4)
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Four
hundred thousand dollars ($400,000) upon the first REGULATORY APPROVAL of
each LICENSED PRODUCT, provided that, if no PATENT has issued in the
United States or Europe which has claims that cover such LICENSED PRODUCT,
then such milestone payment shall be delayed until such time as such
PATENT issues.
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(5)
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Fifteen
thousand dollars ($15,000) upon issuance of a PATENT in the United States,
or issuance of a European PATENT with no subsequent challenge to such
PATENT during the challenge period ;
and
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(6)
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Two
hundred thousand dollars ($200,000) upon the REGULATORY APPROVAL for each
subsequent indication other than cancer, of a LICENSED PRODUCT that was
previously granted REGULATORY APPROVAL for an initial indication, provided
that, if no PATENT that covers such indication has issued at the time this
milestone is achieved, the amount of the milestone shall be reduced from
two hundred thousand dollars ($200,000) to one hundred thousand dollars
($100,000).
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Each of
the foregoing milestone payments shall be made by LICENSEE to UNTHSC (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 Sections 3.3 and 3.4 hereinabove,
including but not limited to up-front payments, marketing, distribution,
franchise, option, license, or documentation fees, research money not
dedicated to LICENSED PRODUCTS, and development money not dedicated to the
preclinical or clinical development of specific LICENSED PRODUCTS, bonus
and milestone payments and equity securities; (payments required to be
used for preclinical or clinical development of specific LICENSED PRODUCTS
shall not be included in the non royalty
consideration. Likewise, payments made to LICENSEE in
consideration of an investment in all or part of the equity securities of
LICENSEE, shall not be included in the non royalty consideration so long
as such equity investment is made in an arms length transaction for fair
market value.
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(1)
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twenty-five
percent (25%) of all non-royalty consideration if the sublicense is
executed before the initiation of a PHASE 2 STUDY;
and
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(2)
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twenty
percent (20%) of all non-royalty consideration if the sublicense is
executed on or after the initiation of a PHASE 2 STUDY;
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 UNTHSC 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 31of each year during the term of this
AGREEMENT (whichever is earlier), at which time LICENSEE wil1 also deliver
to UNTHSC 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 UNTHSC 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 under preclinical development or 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 UNTHSC and/or minimum and royalties;
and
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(g)
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all
consideration received from each sublicensee or assignee and payments due
UNTHSC; and
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(h)
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all
other amounts due UNTHSC
herein.
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Simultaneously
with the delivery of each such report, LICENSEE agrees to pay UNTHSC 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 UNTHSC or its representatives, at UNTHSC’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
to necessary to verify any report required under this AGREEMENT. If any
amounts due UNTHSC 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) 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 UNTHSC 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 or any kind
unless required by the laws of the jurisdiction where sales are
made. In the event that the laws of the jurisdiction in which
sales are made limit the repatriation of funds or the conversion into US
currency, LICENSEE shall use commercially diligent efforts to repatriate
all funds owing to UNTHSC, and shall, in all cases, repatriate funds owed
to UNTHSC in equal proportion to any amounts belonging to LICENSEE which
are repatriated from such jurisdiction. Checks are to be made
payable to The University of North Texas Health Science Center, and sent
by United States mail to 0000 Xxxx Xxxxx Xxxx. Xxxx Xxxxx, Xxxxx
00000-000, Attention: Technology Transfer & Commercialization , and
referencing the title and EFFECTIVE DATE of AGREEMENT and type of payment
(e.g., license documentation fee, milestone payment, royalty [including
applicable patent/application identified UNTHSC reference number and
patent number or application serial number], or maintenance fee,
etc.).
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V.
IND
AND SPONSORED RESEARCH
5.
1
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LICENSEE
shall use commercially diligent efforts to file an Investigational New
Drug Application (“IND") with the FDA for a LICENSED
PRODUCT.
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5.2
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In
addition to the consideration set forth in ARTICLE IV, and the
commercially diligent efforts set forth in 5.1 above, LICENSEE shall spend
at least $250,000.00 towards such preclinical studies, provided that such
expenditures not include compensation of employees of, or consultants to
LICENSEE or standard operational overhead costs of LICENSEE such as
facilities and administrative expenses. Of the $250,000
obligation, at least $100,000 shall be funded within 18 months of the
EFFECTIVE DATE, and an aggregate total of at least $200,000 shall be
funded within two and a half years of the EFFECTIVE
DATE.
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5.3
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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 UNTHSC in writing of all opportunities to conduct this
sponsored research (including clinical trials, if applicable), (b) will
solicit research and/or clinical proposals from UNTHSC for this purpose.
and (c) will give good faith consideration to funding the proposals at
UNTHSC. Any such sponsored research will be governed by a
separate, written agreement between the
parties.
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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 or IMPROVEMENT
PATENTS, UNTHSC will prepare and file appropriate patent applications,
through patent counsel selected by UNTHSC and agreeable to LICENSEE, and
LICENSEE will pay the reasonable cost of searching, preparing, filing,
prosecuting and maintaining same in the following
countries: The United States, Canada, Mexico, The countries of
the European Union, Japan, Australia, China, South Korea, India, Russia,
Israel, Brazil, and such other countries as LICENSEE may designate in
writing to UNTHSC from time to time for a particular patent. If
LICENSEE notifies UNTHSC that it does not intend to pay the cost of an
application in any of the countries set forth above, or if LICENSEE does
not respond or make a good faith effort to agree with UNTHSC on the
disposition of rights of the subject invention within 90 days after actual
written notice, delivered pursuant to the notice provisions of this
Agreement, then UNTHSC may file such application at its own expense and
LICENSEE’s rights to such invention under this AGREEMENT shall terminate
in their entirety. UNTHSC 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
pursuant to this Section confidential. It is intended that
LICENSEE will interact directly with the selected patent counsel in all
phases of patent prosecution, such as preparation, office action
responses, filing strategies for continuation or divisional applications,
and other related activities. UNTHSC will request that copies of all
documents prepared by the selected patent counsel be provided to LICENSEE
for review and comment prior to filing, to the extent practicable under
the circumstances. At its discretion, UNTHSC may allow LICENSEE to
instruct patent counsel directly, provided, that (a) UNTHSC will maintain
final authority in all decisions regarding the prosecution and maintenance
of the PATENT RIGHTS, (b) UNTHSC may revoke this authorization to instruct
patent counsel directly at any time, and (c) the patent counsel remains
counsel to UNTHSC with appropriate contracts, engagement letters and/or
conflict waivers in effect, as necessary. UNTHSC reserves in its
discretion the ability to change patent counsel and to approve or
disapprove any requested changes by
LICENSEE.
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6.2
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Upon
filing of any IMPROVEMENT PATENTS pursuant to section 6.1 in this
Agreement, the parties agree to amend Exhibit 1 in this Agreement such
that PATENT RIGHTS include any such IMPROVEMENT
PATENTS.
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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 as set forth herein. After reimbursement of
LICENSEE’s reasonable legal costs and expenses related to such recovery,
LICENSEE agrees to pay UNTHSC 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)
twenty five percent (25%) of reasonable royalties awarded and related
punitive damages in any monetary recovery in which the award is for
reasonable royalties. LICENSEE must notify UNTHSC 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 UNTHSC may, at its sole discretion, enforce any patent
licensed hereunder on behalf of itself and LICENSEE, with UNTHSC retaining
either: (a) two times 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. UNTHSC
shall not settle any such action upon terms which render the license
granted pursuant to this AGREEMENT non-exclusive or would otherwise be
incompatible with the terms of this AGREEMENT without the written consent
of LICENSEE.
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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.
|
IX.
INDEMNIFICATION
AND INSURANCE
9.1
|
LICENSEE
agrees to hold harmless and indemnify UNTHSC, its Regents, officers,
employees, students and agents from and against any claims, demands, or
causes of action whatsoever, costs 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. In any action brought by a third
party against UNTHSC for an indemnified claim, subject to the statutory
duties of the Texas Attorney General LICENSEE shall control the defense of
such action, and subject to the statutory duties of the Texas Attorney
General shall be responsible for selection of counsel and all aspects of
the action. With UNTHSC’s consent, which will not unreasonably
be withheld or delayed, LICENSEE shall have the right to settle any such
claim with the third party claimant in any manner which would not impose
monetary liability on UNTHSC not reimbursed by LICENSEE’s indemnity
obligations, or which would require an explicit admission of culpability
by UNTHSC. The parties understand and agree that the limitation
of damages in section 9.2 shall not apply to any claim under this
section.
|
18
9.2
|
Except
for indemnified claims under section 9.1 above, in no event shall either
party 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 that party knows or should know of
the possibility or such damages.
|
9.3
|
Beginning
at the time when any LICENSED SUBJECT MATTER is being distributed or sold
for human use (including for 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 UNTHSC, 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
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 limit of LICENSEE's liability with
respect to its indemnification under this AGREEMENT. Prior to
the time when any LICENSED SUBJECT MATTER is being distributed or sold for
human use, LICENSEE shall purchase such insurance as it deems necessary
for LICENSEE’s purposes, provided, however, that in connection with any
commercial general liability insurance policy acquired by LICENSEE,
LICENSEE shall use reasonable efforts to have UNTHSC, its Regents,
officers, employees, students and agents named as additional insureds on
such policy.
|
19
9.4
|
LICENSEE
shall provide UNTHSC with written evidence of such insurance within thirty
(30) calendar days of its procurement. Additionally, LICENSEE
shall provide UNTHSC with written notice at least fifteen (15) calendar
days prior to the cancellation, non-renewal or material change in such
insurance.
|
9.5
|
LICENSEE
shall maintain such commercial general liability insurance beyond the
expiration or termination of this AGREEMENT during: (i) the period that
any LICENSED SUBJECT MATTER developed pursuant to this AGREEMENT is being
commercially distributed sold by LICENSEE, an AFFILIATE or by a
sublicensee or agent of LICENSEE; and (ii) the two (2) year period
immediately alter such period.
|
20
X.
USE
OF UNTHSC'S NAME
10.1 LICENSEE
will not use the name of (or the name of any employee of) UNTHSC in any
advertising, promotional or sales literature, on its Web site, without the
advance express written consent of UNTHSC; notwithstanding the LICENSEE may
disclose the existence of this AGREEMENT and the fact that UNTHSC is the
Licensor under this AGREEMENT for the purposes of raising capital, and LICENSEE
may use the name of (or name employee of) UNTHSC in routine business
correspondence or as needed in appropriate regulatory submissions without
express written consent.
XI.
CONFIDENTIAL
INFORMATION AND PUBLICATION
11.1
|
Subject
to LICENSEE’s rights in 11.2 below, UNTHSC and LICENSEE each agree that
all information contained in documents marked "confidential" and forwarded
to by the other (i) are to be received in strict confidence, (ii) will 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 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
|
21
|
(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
|
|
(f)
|
is
required by law or regulation to be disclosed, provided that the
disclosing party gives adequate advance notice to the other of such
disclosure to allow that party to assert whatever exclusion or exception
may be available to it under such law or
regulation.
|
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, except for confidential information which may be protected by
law or regulation, in which case, such information shall be protected as
long as mandated by such law or regulation requires. LICENSEE shall have
the right to disclose confidential information which is licensed as part
of this AGREEMENT as is reasonably required in the development and
commercialization of LICENSED PRODUCTS so long as such disclosures do not
have an adverse effect on the PATENT
RIGHTS.
|
22
11.3
|
UNTHSC
reserves the right to publish the general scientific findings from
research related to LICENSED SUBJECT MATTER, with due regard the
protection of LICENSEE’s confidential information, the protection of
current and future patent filing opportunities, regulatory and development
concerns and other reasonable considerations relating to the development
of LICENSED PRODUCTS pursuant to this AGREEMENT. UNTHSC will
submit the manuscript of any proposed publication to LICENSEE at least
forty five (45) calendar days before such manuscript is submitted for
consideration by any 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 the
publication. In the event that the parties reasonably determine
that additional research or development work is required or ongoing
research and development needs to be completed in order to secure
appropriate intellectual property protection, and that publication will be
detrimental to obtaining adequate intellectual protection, then, at
LICENSEE’s request and immediate funding of said additional research and
development work, UNTHSC shall delay such publication until completion of
the research or development work and filing of appropriate patents based
upon such work.
|
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
payment to UNTHSC of the fee set forth in 4.1(g) above and the prior
written consent by UNTHSC, which will not be unreasonably
withheld.
|
23
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 for a term of (15) years, whichever is
longer. 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.
|
13.2
|
Any
time after the third anniversary of the EFFECTIVE DATE, UNTHSC has the
right to terminate this license in each of the following political
jurisdictions within the LICENSED TERRITORY if LICENSEE, within ninety
(90) calendar days after receiving written notice from UNTHSC of the
intended termination, fails to provide written evidence satisfactory to
UNTHSC that LICENSEE or its sublicensee(s) has commercialized or is
actively and effectively attempting to commercialize a licensed invention
in such jurisdiction(s); such jurisdictions are as
follows: United States, European Union, Japan, China, India,
Israel, Australia, Brazil. The following definitions apply to 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. Such program may allow for sequential
commercialization in these jurisdictions, (for example, an appropriate
program may envision an initial US approval, and then subsequent EU and
Japanese approval based upon the data and regulatory status of the US
approval.) LICENSEE is not required to simultaneously pursue
all such commercialization activities with equal
resources.
|
24
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 LICENSEE or otherwise;
or
|
|
(b)
|
upon
sixty (60) calendar days written notice from UNTHSC, 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 sixty
(60) calendar day notice period, LICENSEE has cured the default or breach
to UNTHSC’s reasonable satisfaction, and so notifies UNTHSC, stating the
manner of the cure: or
|
|
(c)
|
upon
thirty (30) calendar days written notice from UNTHSC, 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 UNTHSC’s
reasonable satisfaction, and so notifies UNTHSC, stating the manner of the
cure: or
|
25
|
(d)
|
upon
ninety (90) calendars days written notice from UNTHSC 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 UNTHSC’s reasonable satisfaction and so
notifies UNTHSC, stating the manner of the cure;
or
|
|
(e)
|
at
any time upon written notice from LICENSEE to UNTHSC for any reason or for
no reason, provided that such notice shall be subject to rescission and
shall not be effective for 30 days, and during such time, the parties
shall meet together and discuss in good faith the reasons for such
notice. In the event that the AGREEMENT is terminated pursuant
to this notice, termination shall be subject to any terms herein which
survive termination; or
|
|
(f)
|
if
Section 13.2 is invoked, in which case such termination shall be
applicable solely to the jurisdiction in question. No termination for
default of breach under any part of Article XIII shall be effective in the
event that a party disputes in good faith the grounds for such default or
breach. In such event, the dispute shall be resolved as set
forth in 15.4 and 15.5 below, and termination shall be effective only
after final resolution of such dispute as set forth in 15.5 below,
provided that the party found to be in breach or default shall have the
opportunity to cure such breach or default following such resolution as
set forth in 13.3(b-d) above.
|
13.4
|
Upon
termination of AGREEMENT:
|
|
(a)
|
nothing
herein will be construed to release either party of any obligation
maturing prior to the effective date of the termination;
and
|
26
|
(b)
|
LICENSEE
covenants and agrees to be bound by the provisions ARTICLES IX
(Indemnification and Insurance), X (Use of UNTHSC’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 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, UNTHSC represents and warrants its belief that (a) it
has made inquiry into the inventorship and ownership and 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, (c) it has
not granted licenses thereunder to any other entity that would restrict
rights granted hereunder, (d) it does not know of any intellectual
property belonging to UNTHSC which may require a separate license in order
to commercialize LICENSED PRODUCTS pursuant to this AGREEMENT, (e) it has
disclosed to LICENSEE all relevant UNTHSC information relating to the
practice of the TECHNOLOGY RIGHTS and the LICENSED SUBJECT MATTER and has
not fabricated or withheld information from LICENSEE, (f) it will, upon
request, provide LICENSEE with any copies of any and all agreements with
the Government which relate to the LICENSED SUBJECT MATTER, and (g) it has
made any elections to retain ownership which may be required pursuant to
any Government interest in the LICENSED SUBJECT
MATTER..
|
27
14.2
|
LICENSEE
understands that the LICENSED SUBJECT MATTER may have been developed under
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. If
required by law, LICENSEE agrees that LICENSED PRODUCTS used or SOLD in
the United States will be manufactured substantially in the United States,
unless a written waiver is obtained in advance from the
GOVERNMENT.
|
14.3
|
LICENSEE
understands and agrees that other than as expressly set forth in 14.1
above, UNTHSC by this AGREEMENT, makes 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. UNTHSC, by this
AGREEMENT, also makes 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 UNTHSC in the LICENSED FIELD, nor
UNTHSC makes any representation that the inventions contained in PATENT
RIGHTS do not infringe any other patents now held or that will be held by
others..
|
28
14.4
|
LICENSEE,
by execution hereof, acknowledges, covenants and agrees that LICENSEE has
not been induced in any way by UNTHSC 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 to accept all risks inherent
herein.
|
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
UNTHSC to:
|
The
University of North Texas Health Science Center
Office
Technology Transfer & Commercialization
0000 Xxxx
Xxxxx Xxxx.
Xxxx
Xxxxx, Xxxxx 00000
ATTENTION:
Xxxxxx XxXxxxx, Ph.D.
29
or in the
case of LICENSEE to:
SignPath
Pharmaceuticals, Inc.
0000
Xxxxxxxxxx Xxxx
Xxxxxxxxxx,
XX 00000
ATTENTION:
Xxxxxxxx Xxxxxx, MD
AND
SignPath
Pharmaceuticals, Inc.
0000
Xxxxxxxxx Xxxxx
Xxxxxxxx,
XX 00000
ATTENTION:
Xxx X. Xxxxxx
or other
addresses as may be given from time to time under the terms this notice
provision.
15.3
|
LICENSEE
must comply with all applicable federal, state and local laws and
regulations in connection with its activities pursuant to this AGREEMENT.
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
|
The
parties of this AGREEMENT will encourage the prompt and equitable
settlement of all controversies or claims between the parties. The parties
agree to negotiate their differences directly and in good faith for a
period of no less than thirty (30) days after receiving written
notification of the existence of a dispute. If the dispute is not resolved
within thirty (30) days after written notification of the existence of a
dispute, the parties agree to submit their dispute to a licensed attorney
that is an experienced mediator and is located in Tarrant County, Texas to
work with them to resolve their differences utilizing non-binding
mediation. This mediation is a compromise negotiation for purposes of Rule
408 of the Federal Rules of Evidence and Texas Rules of Evidence and is an
alternative dispute resolution procedure subject to Section 154.073 of the
Texas Civil Practice & Remedies Code. If after non-binding mediation
occurs, the dispute is not resolved, the parties are free to exercise all
other legal and equitable
right.
|
30
15.5
|
This
AGREEMENT will be construed and enforced in accordance with the laws of
the United States of America and the State of Texas, without regard to its
conflict of law provisions. Subject to 15.5 below, the Texas State Courts
of Tarrant County, Texas (or, if there is exclusive federal jurisdiction.
the United States District Court for the Northern District of Texas) shall
have exclusive jurisdiction and venue over any dispute arising out of this
AGREEMENT, and LICENSEE consents to the jurisdiction or such courts;
however, nothing in this AGREEMENT shall be deemed as a waiver by UNTHSC
of its sovereign immunity.
|
15.6
|
Failure
of either party to enforce a right under this AGREEMENT will not act as a
waiver of rights 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.
|
31
IN WITNESS WHEREOF, the
parties hereto have caused their duly authorized representative to execute this
AGREEMENT.
HEALTH
SCIENCE CENTER
|
SIGNPATH
PHARMACEUTICALS, INC.
|
|||
By:
|
/s/ Xxxxx Xxxxxx
|
By:
|
/s/ Xxxxxxxx Xxxxxx
|
|
Name:
|
Xxxxx
Xxxxxxx
|
Name:
|
Xxxxxxxx
Xxxxxx
|
|
Title:
|
Executive
Vice President
|
Title:
|
CEO
& President
|
|
Finance
& Administration
|
||||
Date:
|
9/11/08
|
Date:
|
8/28/08
|
|
By:
|
/s/ Xxxxxx Xxxxx
|
|||
Name:
|
Xxxxxx
Xxxxx
|
|||
Title:
|
Executive
Vice President
|
|||
Academic
Affairs & Research
|
||||
Date:
|
9/11/08
|
32
EXHIBIT
1
UNTHSC
Case 2007-10 “FORMULATION OF ACTIVE AGENT LOADED ACTIVATED PLGA NANOPARTICLES
FOR TARGETED CANCER NANO-THERAPEUTICS” Inventors Xx. Xxxxxxx Xxxxxxxxxxx, Xx.
Xxxxxx Xxxxxx, and Xxxxx Xxxxx.
33