EXCLUSIVE LICENSE AGREEMENT
Exhibit
10.4
This
Exclusive License Agreement (the Agreement) is made and entered
into this 15 of May 2006 (the
"Effective Date") by and between the Regents of the University of Colorado, a
body corporate, having its principal office at 000 Xxxxxx Xxxx, Xxxxxx Xxxxx,
Xxxxxxx, XX 00000 (hereinafter "University") and APRO Bio Pharmaceutical
Corporation, a Utah corporation having its principal office at 0000 Xxxxxxx
Xxxxx Xxxx, Xxxx Xxxx Xxxx, Xxxx 00000 (hereinafter
"Licensee").
WHEREAS,
University is the owner of certain Patent Rights (as later defined
herein) invented by University employee Xxxxxx Xxxxxxx, and has the right to
grant licenses under said Patent Rights, and;
WHEREAS,
Licensee is interested in licensing and further developing the Patent
Rights for commercial applications, and;
WHEREAS,
University desires to have the Patent Rights developed and commercialized
to benefit the public and is willing to grant a license
hereunder;
NOW,
THEREFORE, in consideration of the promises and the mutual covenants
contained herein, the parties hereto agree as
follows:
SECTION
1. DEFINITIONS
For the purposes of
this Agreement, the following words and phrases shall have the following
meanings:
1.1
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"Affiliate(s)"
shall mean every corporation or entity, which, directly or indirectly, or
throughone or more
intermediaries, controls, is controlled by, or is under common control
with Licensee, as well as every officer and director of any such
corporation or entity. For the purposes of this definition, the term
"control" means (a) beneficial ownership of at least fifty percent (50%)
of the voting securities of a business organization with voting
securities, or (b) a fifty percent (50%) or greater interest in the net
assets or profits of a partnership or business organization without voting
securities.
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1.2
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"Fields of Use" shall mean the
fields of use identified in Exhibit
A.
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1.3
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"Improvement"
shall mean any invention, the practice of which would also require the
practice of an invention claimed in or covered by the Patent Rights and
which is a modification of the inventions claimed in or covered by the
Patent Rights, made by Xx. Xxxxxx Xxxxxxx, or University researchers
working in the laboratory of Xxxxxx
Xxxxxxx.
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1.4
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"Know-How"
shall mean University's proprietary information which has been created,
developed, or fixed in any tangible medium of expression including, but
not limited to, technical information, devices, models, methods,
documents, and materials, and which is directly related to the
use of, or esirable for the practice of, the licensed Patent
Rights.
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1.5
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"Licensed
Process(es)" shall mean any process, art, or method which is covered in
whole or in part by an issued, unexpired claim or a pending claim
contained in the Patent Rights or that
incorporates or makes use of
Know-How.
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1.6
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"Licensed
Product(s)" shall mean any:
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(a)
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product or
part thereof that is covered in whole or in part by an issued, unexpired
claim or a pending claim contained in the Patent Rights or that
incorporates or makes use of Know-How;
or
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(b)
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product,
chemical composition, apparatus, or part thereof that is manufactured or
discovered by using a Licensed Process(es) or is employed to practice a
Licensed Process(es); or
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(c)
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product
produced, discovered, manufactured or created through the use of any
Licensed Product defined in §1.06(a) or
§1.06(b).
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1.7
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"Net Sales"
shall mean the total gross receipts for sales of Licensed Products or
practice ofLicensed
Processes by or on behalf of Licensee, its Affiliates and sublicensees,
and from leasing, renting, or otherwise making Licensed Products available
to others without sale or other dispositions, whether invoiced or not,
less returns and allowances, packing costs, insurance costs, freight out,
taxes or excise duties imposed on the transaction (if separately invoiced
and paid), and wholesaler and cash discounts in amounts customary in the
trade to the extent actually granted. No deductions shall be made for
commissions, or for the costs of collections. Net Sales shall also include
the fair market value of any non-cash consideration received by Licensee,
its Affiliates and sublicensees, for the sale, lease, or transfer of
Licensed Products or Licensed
Processes.
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1.8
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"Patent
Rights" shall mean all of the following University intellectual property
and any utilityapplications,
PCT applications, continuations, improvements and divisional applications
thereof, patents issuing on any of the foregoing and all reissues,
reexaminations or extensions of any of the foregoing, and any and all
foreign patents and patent applications relating to any of the
foregoing:
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a.
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the United
States and foreign patents and/or patent applications and/or provisional
patent
applications listed in Exhibit
B;
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b.
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United States
and foreign patents issued from the applications listed in Exhibit
B and from divisionals and continuations of these
applications;
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c.
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claims of
U.S. and foreign continuation-in-part applications, and of the resulting
patents,
which are directed to subject matter specifically described in the U.S.
and foreign
applications fisted in Exhibit
B;
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d.
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claims of all
foreign patent applications, and of the resulting patents, which are
directed to subject matter specifically described in the United States
patents and/or patent applications described in this Subsection;
and
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e.
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any reissues
of United States patents described in this
Subsection.
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1.9
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"Territory"
shall mean the geographical area identified in Exhibit
A.
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SECTION
2. GRANT OF LICENSE
2.1
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University
hereby grants and Licensee and Affiliates accept, during the term and
subject tothe terms and
conditions of this Agreement
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a.
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an exclusive, royalty-bearing license to use the Know-How in the Territory and within the Fields of Use; and |
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b.
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an exclusive, royalty-bearing license to University's Patent Rights in the Territory to make, use, sell, lease, offer to sell, and import any Licensed Products in the Fields of Use and to practice any Licensed Processes in the Fields of Use. |
2..2
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All Know-How
due under this Agreement shall be delivered to Licensee prior to or on
theEffective
Date in written, oral or other form of communication. No additional
Know-How shall be due after the Effective
Date.
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2.3
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This Agreement confers no
license or rights by implication, estoppel, or otherwise under any patent
applications or patents of University other than licensed Patent Rights
regardless of whether such patents are dominant or subordinate to licensed
Patent Rights.
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SECTION
3. IMPROVEMENTS & INDEPENDENT INVENTIONS
3.1
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Improvements:
In the event that University develops any improvements to the
inventions claimed in the Patent Rights or to any other preexisting patent
application or patent that is dominated by the Patent Rights, then each
such improvement or addition will be considered part of this Agreement for
no additional
consideration.
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3.2
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Independent Inventions: |
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a.
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Provided that
Xxxxxx Xxxxxxx is at the time obligated to assign intellectual property to
University and is involved as an employee, board member, consultant to or
10% or greater shareholder of Licensee, in the event that Xxxxxx Xxxxxxx
or anybody working in a laboratory under the supervision or direction of
Xxxxxx Xxxxxxx, makes any invention in the Field of Use, the practice of
which would not require the practice of an invention claimed in or covered
by the Licensed Patent Rights ("Independent Invention"), then provided
such Independent Invention is not subject to any prior contractual or
legal obligations, the University hereby grants to Licensee an exclusive
option ("Option") to obtain the exclusive, worldwide, commercial rights to
each Independent Invention on terms and conditions to be negotiated in
good faith by the parties following the exercise by Licensee of the
Option. In addition, Licensee shall have such further rights to future
Independent Inventions as may be set forth in the sponsored research
agreement described in Exhibit E
to be entered into between the
Parties.
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b.
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University shall disclose each
Independent Invention to Licensee in reasonable written
detail after the University's Technology Transfer Office receives
notification from the inventor(s) that such Independent Invention has been
made, and Licensee shall have ninety (90) days (the "Option Period")
following receipt of such invention disclosure to exercise the Option with
respect to such Independent Invention by delivering to University written
notice indicating that Licensee desires to exercise the Option. Upon such
notice, the parties shall negotiate in good faith for a period of up to
sixty (60) days commercially reasonable terms and conditions for a
license under the intellectual property rights relating to such
Independent
Invention
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SECTION
4. SUBLICENSING
4.1
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Upon prior
written approval by University, such approval not to be unreasonable
withheld,Licensee may
sublicense to one or more third parties, the rights granted in Section 2
subject to the following
limitations:
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a.
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Licensee
agrees that any sublicenses granted by it shall impose restrictions and
conditions upon sublicensees equivalent in scope to those imposed upon
Licensee;
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b.
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Licensee
agrees that, in the event University terminates this Agreement pursuant to
Subsection 13,2(b), any sublicenses granted, in University's sole
discretion, shall be directly enforceable by
University;
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c.
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Licensee
agrees that any sublicenses granted shall adequately protect University's
security and
property interest in University's Know-How and Patent Rights;
and
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d.
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Any
sublicenses granted by Licensee shall provide only for cash consideration
from sublicensees
unless University has expressly consented otherwise in writing in advance.
Any sublicenses made in other than arm's-length transactions, the value of
the transaction attributed under this Section to such a transaction shall
be that which would have been received in an arm's-length transaction,
based on a like transaction at that time.
For purposes
of this Agreement, the term "sublicense" shall mean the license by
Licensee to a third party of all or a portion of the intellectual property
rights licensed to it by University hereunder in consideration of payments
from such sublicensee to Licensee, and shall not include Licensee's
engagement of or joint venture with subcontractors to perform various
services for
Licensee in connection with its development of the Licensed
Products and Licensed Processes, including, but not limited to, laboratory
work, pre-clinical and clinical testing, assistance with the regulatory
approval process, manufacturing, marketing and other similar product
development services provided that such services are for the sole benefit
of Licensee and such third party does not have any independent use of the
Patent Rights or Know-How. Licensee agrees to assume all obligations for
protecting the University's security and property interest in University's
Know-How and Patent Rights in any such joint venture work consistent with
the terms of this Agreement.
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4.2
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Licensee
agrees to forward to University a copy of each fully executed
sublicenseagreement
postmarked within thirty (30) days of the execution of such
agreement.
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SECTION
5. RETAINED RIGHTS 5.1Government
Rights:
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a.
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Notwithstanding
any use of descriptive terms within this Agreement such as "exclusive",
this Agreement is subject to all of the terms and conditions of Title 35
U.S.C. §§ 000-000, xx xxx., ("Xxxx-Xxxx Xxx") and 37 C.F.R.
401, as such may be amended.
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b.
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Further,
Licensee agrees to take all reasonable action necessary to enable
University to satisfy its obligations
hereunder.
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5.2
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University
Rights:
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a.
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University
shall have the right to practice the Patent Rights and Know-How for its
own research and education, including sponsored research, which right
shall be transferable to other nonprofit or educational institutions;
provided that University takes reasonable steps to prevent the commercial
use of any products or processes resulting from such research and
education and to avoid the loss of any patent rights as a result of such
activities.
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b.
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University
shall have the right to publish any information included in the Patent
Rights and the Know-How provided that University takes reasonable steps to
avoid the loss of any patent rights as a result of University exercising
its rights under this Paragraph. University shall provide Licensee with
ten (10) days' advance notice of any such publication, including a
copy of the information proposed to be
published.
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SECTION
6. FEES & ROYALTIES
6.1
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As
consideration for the disclosure of University's Know-How as well as the
licenses andrights under
University's Patent Rights,
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a.
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Licensee
agrees to pay to University an annual, nonrefundable minimum royalty as
set forth in Exhibit
C. The minimum annual royalty is due and payable on first business
day of each calendar year and may be credited against any earned royalties
due for Net Sales made that year;
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b.
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Licensee
agrees to pay University royalties as set forth in Exhibit
C;
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6.2
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No multiple
royalties shall be payable because any Licensed Products or
Licensed
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Processes are
covered by more than one of the Patent Rights.
6.3
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On sales of
Licensed Products by Licensee to sublicensees or on sales made in other
than arm's-length transactions, the value of the Net Sales attributed
under this Section to such a transaction shall be that which would have
been received in an arm's-length transaction, based on a like transaction
at that time.
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6.4
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Payment
Due Date:
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a.
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Unless
otherwise provided herein, all payments required under this Agreement
shall be due within thirty (30) days of written notice from
University.
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b.
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Payments past
due shall bear interest at the rate of one and one-half percent (1 1/2%)
per month compounded, or the maximum interest rate allowed by applicable
law, whichever is less.
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SECTION
7. REPORTS, RECORDS, AND AUDITS 7.1 Reports:
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a.
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Licensee
shall, without request by University, within sixty (60) days following
the
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end of each
fiscal quarter of Licensee and sixty (60) days following the end of
Licensee's fiscal year, render to University written reports of the Net
Sales of Licensed Products and/or Licensed Processes subject to royalty
hereunder made during the prior three (3) month period and shall
simultaneously pay to University the royalties due on such Net Sales, if
any, in United States Dollars. Licensee shall not be required to provide
any such reports during the period prior to its initial sale of Licensed
Products and/or Licensed Processes.
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b.
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Minimum
annual royalties, if any, which are due University for any fiscal year,
shall be paid by
Licensee along with the written report due under this Agreement with
respect to such fiscal year.
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c.
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Unless
otherwise agreed to by the Parties, the written report shall be in the
substantially the same form as
Exhibit
D.
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7.2
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Records:
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a.
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Licensee
shall
keep accurate
records and shall compel its Affiliates and sublicensees
to keep accurate records, in sufficient detail to reflect its operations
under this Agreement and to enable the royalties accrued and payable under
this Agreement to be
determined.
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b.
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Such records
shall be retained for at least three (3) years after the close of the
period
to which they pertain, or for such longer time as may be required to
finally resolve any question or discrepancy raised by
University.
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7.3
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Audits:
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a.
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Upon the
request of University, with reasonable notice, but not more frequently
than once a year,
Licensee shall permit an independent public accountant selected and paid
by University to have access during regular business hours to such records
as may be necessary to verify the accuracy of royalty payments made or
payable hereunder.
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b.
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Said
accountant shall disclose information acquired to University only to the
extent that it
should properly have been contained in the royalty reports required under
this Agreement.
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c.
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If an
inspection shows an underreporting or underpayment in excess of five
percent (5%) for any
twelve (12) month period, then Licensee shall reimburse University for the
cost of the inspection and pay the amount of the underpayment including
any interest as required by this
Agreement.
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SECTION
8. CONFIDENTIAL INFORMATION
8.1
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Both
University and Licensee (hereinafter, "Party" or "Parties") shall
vigilantly protect theconfidential
information related to the Patent Rights and Know-How from disclosure to
third parties; and no such disclosure shall be made without the disclosing
Party's written permission.
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8..2
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All written
documents containing confidential information and other material in
tangible formreceived by
either Party under this Agreement shall remain the property of the
disclosing Party, and such documents and materials, together with copies
of excerpts thereof, shall promptly be returned to disclosing Party upon
request, except one copy may be retained for archival
purposes.
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8.3
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Licensee
acknowledges that University is subject to the Colorado Open Records
Act(C.R.S. §
00-00-000, et seq.). All plans and reports marked "Confidential" shall be
treated by University as confidential to the extent permitted under §
00-00-000.
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SECTION
9. LICENSEE DUE DILIGENCE OBLIGATIONS
9.1
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Licensee
shall use commercially reasonable efforts to bring Licensed Products
andLicensed
Processes to market through a thorough, vigorous and diligent program
for exploitation of the Patent Rights,
to develop internal or external manufacturing capabilities, to continue
active, diligent marketing efforts, and to satisfy the needs of such
market with the Licensed Products and Licensed Processes throughout the
life of this Agreement.
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9.2
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Licensee
acknowledges and agrees to the performance and diligence milestones
defined inExhibit
E provided
however that specific dates for such milestones may be adjusted if
required due to developments beyond the reasonable control of Licensee. No
changes to the dates of such milestones will be made without the consent,
which will not be unreasonably denied, of
University.
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9.3
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Licensee
agrees to use commercially reasonable efforts to develop a sublicensing
programto
commercialize Licensed Products and Licensed Processes in any Field of Use
or Territory that Licensee decides not to exploit for its own
benefit.
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SECTION
10.
PATENT ADMINISTRATION
10.1
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Licensee
shall reimburse University within thirty (30) days from the Effective Date
twentythousand
dollars ($20,000) representing all patent expenses incurred by University
prior to the Effective
Date.
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10.2
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Licensee
Rights:
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a.
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Licensee
shall control the preparation, filing, prosecution, and maintenance of any
and all patent applications or patents included in the Patent Rights on or
after the Effective Date and shall furnish copies of relevant
patent-related documents to University. Licensee shall provide University
with advance written notice of its plans to file or prosecute any such
patent applications or patents. University shall cooperate with Licensee
in providing any additional scientific and other information reasonably
necessary for Licensee to prepare, file, prosecute and maintain such
patent applications and patents.
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(i)
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University
shall have thirty (30) business days to review and comment on
patent-related documents prior to the filing of said
documents.
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b.
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Licensee may
request that University assume primary responsibility for all patent
activities, including all costs, associated with the perfection and
maintenance of Patent Rights. Licensee shall provide University with sixty
(60) days' advance written notice of such request. In the event University
agrees to such
request:
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(i)
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University's
patent counsel shall keep Licensee advised as to the status of the Patent
Rights by providing Licensee, in a timely manner prior to their due date,
with copies of all official documents and correspondence relating to the
prosecution, maintenance, and validity of the Patent
Rights.
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(ii)
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University shall consult with Licensee in such prosecution and maintenance, shall diligently seek Licensee's advice on all matters pertaining to the Patent Rights, shall diligently seek strong and broad claims under the Patent Rights, and shall not abandon prosecution of any patent application without first notifying Licensee sixty (60) days prior to any bar date, of University's intention and reason therefore, and providing Licensee with reasonable opportunity to assume responsibility for prosecution, maintenance and associated costs of such patents and patent applications. |
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c.
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No claims of the Patent Rights shall be modified, deleted, or abandoned by Licensee or its patent counsel without the express, prior written approval of University, such approval shall not be unreasonably withheld or delayed. |
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(i)
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Licensee's
obligations under this Subsection shall include, without limitation, an
obligation to inform University in a timely manner that Licensee will not
pursue patents in any foreign countries where patent protection may be
available such that University may prosecute patents in such countries if
University so desires.
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(ii)
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If University pursues such foreign patent protection, then from that time forward all such subject patent applications and any patents arising there from shall no longer be considered Patent Rights under this Agreement and Licensee shall forfeit all rights under this Agreement to such patent applications and any patents arising there from. University shall be responsible for all costs associated with those patent applications and patents it decides to pursue and maintain. |
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d.
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At any time, University may
provide Licensee with thirty (30) days' advance written
notice that
University wishes to resume control, at Licensee's expense, of the
preparation, filing, prosecution, and maintenance of any and all patent
applications or patents included in the Patent Rights. If University
elects to resume such responsibilities, Licensee agrees to cooperate fully
with University, its attorneys, and agents in the preparation, filing,
prosecution, and maintenance of any and all patent applications or patents
and to provide University with complete copies of any and all documents or
other materials that University deems necessary to undertake such
responsibilities.
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SECTION
11. PATENT ENFORCEMENT
11.1
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University
and Licensee agree to inform the other Party promptly in writing of
anysuspected
infringement of the Patent Rights by a third party. Licensee shall have,
for a period of 120 days from the date of any notice of infringement of
the Patent Rights, the first right to institute suit against such third
party and any recovery or settlement shall be applied first to defray the
unreimbursed costs and expenses (including reasonable attorneys' fees)
incurred by Licensee in the action, second to pay University an amount
equal to the Sublicensing Royalty that University would otherwise be
entitled to at that time pursuant to Exhibit C to this Agreement if the
amount remaining after the reimbursement of costs and expenses was treated
as Sublicensing revenue, and third any remaining balance shall be paid to
Licensee.
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11.2
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Thereafter,
University and Licensee shall each have the right to institute an action
forinfringement
of the Patent Rights against such third party in accordance with the
following:
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a.
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If both
University and Licensee agree to institute suit jointly, the suit shall be
brought
in both their names, the out-of-pocket costs thereof shall be borne
equally, and any recovery or settlement, after the reimbursement of costs
and expenses (including reasonable attorneys' fees incurred in the action,
shall be shared equally.
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b.
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University
and Licensee shall agree to the manner in which they shall exercise control over
such suit. Each Party, at its option, may be represented by separate
counsel of its own selection, the fees for which shall be paid by
University.
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c.
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In the
absence of an agreement to institute a suit jointly, University may, but
is not obligated to,
institute suit, and at its option, join Licensee as a plaintiff. If
University decides to institute suit, it shall notify Licensee in
writing.
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d.
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Licensee's
failure to notify University in writing within thirty (30) days after the
date of
University's notice pursuant to 11.2(c) above, that it will join in
enforcing the Patent Rights pursuant to the terms hereof, shall be deemed
conclusively to be Licensee's assignment to University of all rights,
causes of action, and damages resulting from any such alleged
infringement. University shall bear the entire cost of such litigation and
shall be entitled to retain the entire amount of any recovery or
settlement.
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e.
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In the absence of an agreement to institute a suit jointly, and if University does not notify Licensee of its intent to pursue legal action within ninety (90) days, as provided in Subsections 11.1 — 11.2, Licensee may again have the right to institute suit. In such event, Licensee shall bear the entire cost of such litigation and any recovery or settlement shall be applied first to defray the unreimbursed costs and expenses (including reasonable attorneys' fees) incurred by Licensee in the action, second to pay University an amount equal to the Earned Royalty that University would otherwise be entitled to pursuant to Exhibit C to this Agreement if the amount remaining after the reimbursement of costs and expenses was treated as Net Sales, and third any remaining balance shall be paid to Licensee. |
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f.
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If Licensee undertakes to defend the Patent Rights by litigation, Licensee may deduct from its royalty payments to University with respect to the Patent Rights subject to suit an amount not exceeding fifty (50%) of Licensee's expenses and costs of such action, including reasonable attorney's fees, provided however, that such reduction shall not exceed fifty percent (50%) of the total royalty due to University for each calendar year. |
11.3
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In the event
that a declaratory judgment action alleging invalidity or non-infringement
of any of the Patent Rights shall be brought against Licensee or raised by
way of counterclaim or affirmative defense in an infringement suit brought
by Licensee under this Section, pursuant to this Agreement and the
provisions of Title 35 U.S.C. § 29 or other statutes, Licensee
may:
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a.
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defend the suit in its own name, at its own expense, and on its own behalf for presumably valid claims in the Patent Rights; |
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b.
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in any such suit, ultimately to enjoin infringement and to collect for its use, damages, profits, and awards of whatever nature recoverable for such infringement consistent with this Section; and |
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c
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settle any
claim. or suit for declaratory judgment involving the Patent Rights, except that
Licensee shall have no right to deny the validity of any patent, patent
claim, or patent application included in the Patent Rights in any
compromise or settlement of any claim or suit for declaratory judgment
without the express prior written consent of University; provided however,
that University shall have the first right to take such actions described
in this Subsection and shall have a continuing right to intervene in such
suit. Licensee shall take no action to compel University either to
initiate or to join in any such declaratory judgment
action.
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d.
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If Licensee
elects not to defend against such declaratory judgment action, University,
at its option, may do so at its own expense and shall be entitled to
retain the entire amount of any recovery or
settlement.
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11.4
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In all cases,
Licensee agrees to keep University reasonably apprised of the status
andprogress of
any litigation.
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SECTION
12. WARRANTIES, INDEMNIFICATIONS, AND INSURANCE
12.1
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Representations.
University is the owner of the Patent Rights and has full right and
authority to
enter into this Agreement.
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12.2
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Negation
of Warranties:
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a.
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UNIVERSITY
MAKES NO REPRESENTATIONS, EXTENDS NO WARRANTIES OF ANY KIND,
EITHER EXPRESS OR IMPLIED, AND ASSUMES NO RESPONSIBILITIES WHATSOEVER WITH
RESPECT TO USE, SALE, OR OTHER DISPOSITION BY LICENSEE, SUBLICENSEE(S), OR
THEIR VENDEES OR OTHER TRANSFEREES OF LICENSED PRODUCTS OR LICENSED
PROCESSES INCORPORATING OR MADE BY USE OF THE PATENT RIGHTS. THERE ARE NO
EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE, OR THAT THE USE OR SALE OF SUCH PRODUCTS OR PROCESSES
WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, SERVICE XXXX, OR OTHER
RIGHTS.
|
|
b.
|
Notwithstanding
anything in this Agreement to the contrary, nothing in this Agreement
shall be construed as:
|
|
(i).
|
A warranty or
representation by University as to rights in Know-How or the validity or
scope of any of the Patent
Rights;
|
|
(ii).
|
A warranty or
representation that the Patent Rights or anything made, used, sold or
otherwise disposed of under the License will or will not infringe patents,
copyrights or other rights of third parties;
or
|
|
(iii).
|
An obligation
to furnish any know-how or technology not agreed to in this Agreement, to
bring or prosecute actions or suits against third parties for infringement
(except to the extent described in Subsections 11.1 — 11.2), or to provide
any services other than those specified in this
Agreement.
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12.2
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Indemnification:
Licensee shall indemnify, defend, and hold University, its regents,
employees,
students, officers, agents, Affiliates, and representatives harmless from
and against all liability, demands, damages, losses, and expenses
(including reasonable attorney fees) (collectively, "Claims"), for death,
personal injury, illness, property damage, noncompliance with applicable
laws and any other claim, proceeding, demand, expense and liability of
any kind whatsoever in connection with or arising out
of:
|
|
a.
|
the use by or
on behalf of Licensee, its sublicensees, Affiliates, directors, officers,
employees, or
third parties of any Patent
Rights;
|
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b.
|
the design,
manufacture, production, distribution, advertisement, consumption, sale, lease,
sublicense or use of any Licensed Product(s), Licensed Process(es) or
materials by Licensee, or other products or processes developed in
connection with or arising out of the Patent Rights;
or
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c.
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any right or
obligation of Licensee under this
Agreement.
|
With respect to
Licensee's indemnification provided for in this Section 12.3, the following
provision shall apply, Licensee shall (i) receive prompt notification from
University in writing of any such Claims, (ii) have full authority, information
and assistance from University to defend such Claims, and (iii) have sole
control over the defense of such Claims and all negotiations for the compromise
or settlement thereof.
12.3
|
Insurance:
Licensee shall obtain general
liability insurance, including product liability insurance, on
such terms and in
such amounts as are reasonable and customary within its
industry.
|
SECTION
13. DURATION, TERMINATION, AND CONVERSION
13.1
|
This
Agreement shall become effective as of the Effective Date and shall expire
on theexpiration
date of the last to expire patents within Patent
Rights.
|
13.2
|
Termination
of Agreement:
|
a. Licensee
may terminate this Agreement at any time on sixty (60) days written notice to
University, if Licensee:
|
(i).
|
pays all amounts due as well as all non-cancelable costs to University through the termination date; |
|
(ii).
|
submits a final report of the type described in Section 7; |
|
(iii).
|
returns any
confidential materials provided to Licensee by University in connection
with this Agreement;
|
|
(iv).
|
suspends its
use and sales of the Licensed Product(s) and Licensed Process(es);
provided however, that subject to making the payments required by Section
6 and the reports required by Section 7, Licensee may, for a period of
ninety (90) days after the effective date of such termination, sell all
Licensed Products which may be in inventory;
and
|
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(v).
|
provides University the right to access any regulatory information filed with any U.S. or foreign government agency with respect to Licensed Products and Licensed Processes. |
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b.
|
University
may terminate this Agreement in the event that:
Licensee
fails to pay University any amounts when due to University hereunder and
Licensee fails to make such payment within thirty (30) days written
notice;
|
|
(ii).
|
Licensee becomes insolvent, files a petition in bankruptcy, or has such a petition filed against it and such petition is not dismissed within sixty (60) days of the filing date, or |
|
(iii).
|
Licensee is in breach or default of this Agreement .other than those occurrences listed in this Subsection and Licensee fails to cure the breach or default within thirty (30) days of written notice of the breach or default unless such breach or default is of a character that cannot be cured within thirty (30) days, in which event, Licensee shall not be deemed to be in default hereunder unless it fails to diligently commence and pursue action to cure such default during such thirty day period. Events constituting a breach or default shall include, but are not limited to, the following: |
|
(a)
|
failure by
Licensee to meet any material due diligence requirement of Exhibit
E; in this event, University retains the right to convert this
Agreement to a non-exclusive
Agreement,
|
|
(b)
|
operation,
manufacture, use of or sale of the Licensed Products or Licensed Processes
outside the Fields of Use or
Territory;
|
|
(c)
|
failure to
keep adequate records or permit inspection or
audit.
|
|
c.
|
The exclusive license granted by this Agreement shall immediately revert to University upon Licensee's dissolution, liquidation, insolvency, or bankruptcy. The exclusive license shall NOT pass to a trustee in bankruptcy or be held as an asset of said bankrupt. |
.
SECTION
14. GENERAL
14,1
|
Assignment:
This Agreement shall be binding upon and inure to the benefit of
the respective
successors and assigns of the Parties hereto, However, Licensee may not
assign its rights in this Agreement without prior written approval by
University, such approval not to be unreasonably withheld or
delayed.
|
14.2
|
Notice:
Notice hereunder shall be deemed sufficient if given by registered
mail, postage prepaid, and
addressed to the Party to receive such notice at the address given below,
or such other address as may
hereafter be designated by notice in
writing.
|
University:
License
Administrator
Office of
Technology Transfer
University of
Colorado, 000 XXX Xxxxx
000, 0000 Xxxxxxxxx Xxxxx Xxxxxxx, XX
00000-0000
|
Licensee:
APRO Bio
Pharmaceutical Corporation Atten: Xxxxx Floor, Secretary
0000 Xxxxxxx
Xxxxx Xxxx
Xxxx Xxxx Xxxx,
Xxxx
00000
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14.3
|
Use
of Names and Marks: Licensee agrees not to identify University in
any promotional advertising, press releases, sales literature or other
promotional materials to be disseminated to the public or any portion
thereof without University prior written consent in each case, except that
Licensee may state that it has a license for the Patent Rights from
University. Licensee further agrees not to use the name of University or
any University faculty member, inventor, employee or student or any
trademark, service xxxx, trade name, copyright or symbol of University,
without the prior written consent of the University, entity or person
whose name is sought to be used, which consent shall not be unreasonably
withheld or delayed.
|
14.4
|
Marking:
Licensee agrees to:
|
|
a.
|
Cause
Licensed Products or the product of Licensed Processes sold under this
license to be marked with the notice of the patent numbers or patent
pending, as may be appropriate.
|
|
b.
|
Comply with
all laws and regulations of the United States and any other country as
appropriate concerning or controlling the import or export of the Licensed
Products, data, software, laboratory prototypes or other commodities.
University makes no representation that a license or consent for export
will not be required by applicable governmental agencies, or if required,
that it will be issued.
|
|
c.
|
Comply with
all applicable statutes, regulations, and guidelines, including applicable
governmental regulations, policies and guidelines in its use of any
University- supplied materials. Licensee agrees not to use the materials
for research involving human subjects or clinical trials in the United
States without complying with 21 C.F.R. Part 50 and 45 C.F.R. Part 46 (as
those regulations may be amended from time to time). Licensee agrees not
to use the materials for research involving human subjects or clinical
trials outside of the United States without notifying University in
writing, of such research or trials and complying with the applicable
regulations of the appropriate national control authorities. Written
notification to University of research involving human subjects or
clinical trials outside of the United States shall be given no later than
sixty (60) days prior to commencement of such research or
trials.
|
14.5
|
Compliance
with the Law: Licensee shall comply with all commercially material
local, state,
federal, and international laws and regulations relating to its
obligations under this Agreement regarding the development, manufacture,
use, and sale of Licensed Products and Licensed
Processes.
|
14.6
|
Choice
of Law: This Agreement shall be governed by and construed in
accordance with the laws of the State of
Colorado.
|
14.7
|
Dispute
Resolution: In the event of any dispute arising out of or relating
to this Agreement, the affected Party shall promptly notify the other
Party ("Notice Date"), and the Parties shall attempt in good faith to
resolve the matter.
|
|
a.
|
Any disputes
not so resolved shall be referred to senior executives, who shall meet at
a mutually acceptable time and location within thirty (30) days of the
Notice Date and shall attempt to negotiate a
settlement.
|
|
b.
|
If the senior
executives fail to meet within thirty (30) days of the Notice Date, or if
the matter remains unresolved for a period of sixty (60) days after the
Notice Date,
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the Parties hereby
irrevocably submit to the jurisdiction of a court of competent jurisdiction in
the State of Colorado, and, by execution and delivery of this Agreement, each
(i) accepts, generally and unconditionally, the jurisdiction of such court and
any related appellate court, and (ii) irrevocably waives any objection it may
now or hereafter have as to the venue of any such suit, action or proceeding
brought in such court or that such court is an inconvenient forum.
14.8
|
Merger
and Modification of Agreement: The terms and provisions contained
in this Agreement constitute the entire Agreement between the Parties and
shall supersede all previous communications, representations, agreements
or understandings, either oral or written, between the Parties hereto with
respect to the subject matter hereof, and no agreement or understanding
varying or extending this Agreement will be binding upon either Party
hereto, unless in writing which specifically refers to this Agreement,
signed by duly authorized officers or representatives of the respective
Parties, and the provisions of this Agreement not specifically amended
thereby shall remain in full force and effect according to their
terms.
|
14.9
|
Severability;
The provisions and clauses of this Agreement are severable, and in the
event that any provision or clause is determined to be invalid or
unenforceable under any controlling body of the law, such invalidity or
unenforceability will not in any way affect the validity or enforceability
of the remaining provisions and clauses
hereof.
|
14.10
|
Scope:
This Agreement does not establish a joint venture, agency or partnership
between the Parties, nor create an employer - employee
relationship.
|
14.11
|
Preservation
of Immunity: The Parties agree that nothing in this Agreement is
intended or shall be construed as a waiver, either express or
implied, of any of the immunities, rights, benefits, defenses or
protections provided to University under governmental or sovereign
immunity laws from time to time applicable to University, including,
without limitation, the Colorado Governmental Immunity Act (C.R.S. §
00-00-000, et seq.) and the Eleventh Amendment to the United States
Constitution.
|
14.12
|
Headings:
Headings are included herein for convenience only and shall not be used to
construe this Agreement.
|
14.13
|
The
provisions of Sections 6 and 10, and Subsections 7.1, 7.2, 12.1, 12.2,
13.1, 14.3, 14.6 — 14.9, and 14.11, and any other provision of this
Agreement that by its nature is intended to survive, shall survive any
termination or expiration of this
Agreement.
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IN WITNESS WHEREOF the parties
hereto have caused this Agreement, to be executed in duplicate by their
respective duly authorized officers.
University: /s/ Xxxxx X.
Xxxxx
|
Licensee:
/s/ Xxxxx Floor
|
By: Xxxxx
X. Xxxxx
|
By:
Xxxxx Floor
|
Title:
Associate VP for Technology Transfer
|
Title:
Executive VP
|
Date: 19
April ’06
|
Date:
5/15/06
|
Office
of Technology Transfer
|
APRO
Bio Pharmaceutical Corporation
|
University
of Colorado
|
0000
Xxxxxxx Xxxxx Xxxx
|
Xxxxx
000, 0000 Xxxxxxxxx Xxxxx
|
|
588
SYS
|
Xxxx
Xxxx Xxxx, Xxxx 00000
|
Xxxxxxx,
XX 00000-0000
|
|
Approved
as to Legal Sufficiency:
|
|
By:
/s/ Xxxxxxx
Xxxxxxx
|
|
Title: Asst.
Univ. Counsel
|
|
Date:
19 April ‘06
|
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EXHIBIT
A
FIELDS
OF USE and TERRITORY
-
Fields
of use: treatment of bacterial infections; and all research,
studies, testing, preclinical and clinical testing and developments relating to
internal, topical or other treatment of bacterial infections, including the
treatment of (i) Anthrax, (ii) Mycobacterium Tuberculosis (TB) and other
Mycobacteria and (iii) Bacterial Pneumonia, and further including the cutaneous
anthrax cream .
Territory:
worldwide.
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EXHIBIT
B
PATENT
RIGHTS
|
1.
|
"Inhibitors
Of Serine Protease Activity And Their Use In Methods And Compositions For
Treatment Of Bacterial Infections" PCT/USO4/27711, filed August 26,
2004
|
|
2.
|
"Inhibitors
Of Serine Protease Activity And Their Use In Methods And Compositions For
Treatment Of Bacterial Infections" United States Patent Application US
10/925,051, filed August 26, 2004
|
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EXHIBIT
C
ROYALTIES
In
accordance with Section 6, Licensee shall pay the following royalties to
University:
Minimum annual
royalty:
|
Twenty five
thousand dollars ($25,000) payable on each anniversary of the Effective
Date commencing with the fifth anniversary of the Effective Date. The
minimum annual royalty shall be deductible from any earned royalties due
the University.
|
Earned
royalty:
|
Four percent
(4%) of Net Sales.
|
Milestone
royalties per indication, other than Anthrax which is specifically
excluded, are as follows:
|
|
Upon the
completion of any preclinical testing, including animal testing, for any
Licensed Product, Licensee shall pay thirty thousand dollars ($30,000),
within thirty (30) days of completion of such preclinical trial. There
shall be no subsequent fee for any additional or supplemental preclinical
testing.
|
|
Upon the
completion of any phase I clinical trial for any Licensed Product,
Licensee shall pay a one-time fee of fifty thousand dollars ($50,000)
within sixty (60) days of completion of such clinical trial.
Upon the
completion of any phase II clinical trial for any Licensed Product,
Licensee shall pay a one-time fee of one hundred thousand dollars
($100,000) within sixty (60) days of completion of such clinical
trial.
|
|
Upon the
completion of any phase Ill clinical trial for any Licensed Product,
Licensee shall pay a one-time fee of two hundred thousand dollars
($200,000) within sixty (60) days of completion of such clinical
trial.
|
|
Upon approval
from the United States Food and Drug Administration (FDA), or foreign
equivalent, of any Licensed Product, Licensee shall pay three hundred
thousand dollars ($ 300,000) within sixty (60) days of such
approval.
|
|
Sublicensing
royalties as follows:
|
|
Thirty
percent (30%) of all Sublicensing revenue received during the first year
after the Effective Date.
|
|
Twenty-Five
percent (25%) of all Sublicensing revenue received during the second year
after the Effective Date.
|
|
|
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Expiration of
Royalties:
|
Twenty
percent (20%) of all Sublicensing revenue received during the third year
after the Effective Date and each year thereafter until this Agreement is
terminated or expires.
All royalties
payable hereunder (minimum royalties, earned royalties and sublicensing
royalties) with respect to each Licensed Product or Licensed Process shall
expire and terminate on the respective expiration date of the Patent
Rights applicable to each such Licensed Product or Licensed
Process.
|
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EXHIBIT
D
FORM OF
ROYALTY REPORT
Licensee:
____________________________________________
|
Case
No.: _______________________________________
|
Inventor:
____________________________________________
|
Patent
No. _______________________________________
|
Period
Covered: From: __________________________________
|
Through:
_________________________________________
|
Prepared
By: _________________________________________
|
Date:
____________________________________________
|
Approved
By: ________________________________________
|
Date:
____________________________________________
|
If
license covers several major product lines, please prepare a separate report
for each
line. Then combine all product lines into a summary report.
A
discussion of the progress and results, as well as ongoing plans, with respect
to the Licensed Products
and/or Licensed Processes, see § 6.01, is attached.
Report Type: | ____ | Single Product Line Report: ______________________ | |||
____ | Multiproduct Summary Report Page 1 of ___ Pages | ||||
____ | Product Line Detail | Line: _______ | Trademark: _______ | Pages _______ | |
Country
|
Gross
Sales
|
*
Less:
Allowances
|
Net
Sales
|
Royalty
Rate
|
Period
Royalty Amount
|
|
This
Year
|
Last
Year
|
|||||
U.S.A.
|
||||||
Canada
|
||||||
Europe
|
||||||
Japan
|
||||||
Other:
|
||||||
TOTAL:
|
Sublicense
Fees this quarter: $ ____ (attach page showing names, addresses, and
telephone numbers;
and amount of fees received; territory; field of use)
Total
Royalty: $ ____
The
following royalty forecast is non-binding and for University internal planning
purposes only:
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EXHIBIT
E
PERFORMANCE
MILESTONES
Milestones are defined for the first
indication
Pre Clinical
testing
|
4Q/07
|
Phase Ill
initiation
|
40/09
|
FDA
submission
|
4Q/11
|
Market
launch
|
4Q/13
|
DILIGENCE
MILESTONES
1. Company
shall deliver to University:
|
(a)
|
within
forty-five (45) days of the
Effective Date, a comprehensive business plan that describes the Company's
technology commercialization strategy, including product development plans
and timelines, marketing strategies, and plans for obtaining necessary
financing. The business plan shall include forecasts showing the funds,
personnel, and time budgeted and planned for development of the
Intellectual Property Rights and Know- How;
and
|
|
(b)
|
within thirty
(30) days of the Effective Date, evidence that Company has secured funding
commitments of three hundred thousand dollars ($
300,000)
|
2. Company
shall negotiate with the University and enter into a sponsored research
agreement for the benefit of Xx. Xxxxxx Xxxxxxx which shall include a
requirement to initiate a program to perform animal toxin testing for an amount
not less than sixty-five thousand dollars ($65,000) within thirty (30) days of
the Effective Date.
3. From
its inception through that date which is twelve (12) months of Effective Date,
the Company shall have raised a minimum of nine hundred thousand dollars
($900,000) in debt or equity capital.
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