Exhibit 10.9
[[University of
Colorado Stamp]]
EXCLUSIVE LICENSE
AGREEMENT
This Exclusive License Agreement
(the “Agreement”) is
made and entered into this 12 th of November, 2008, (the
“Effective Date”) by and between the Regents of the
University of Colorado, a body corporate, having its principal
office at 1800 Grant Street, 8 th Floor, Denver, CO 80203 (hereinafter
“University”) and APRO Bio Pharmaceutical Corporation,
a Colorado corporation having a principal place of business at 5350
S. Roslyn St. #400, Greenwood Village, CO 80111 (hereinafter
“Licensee”).
WHEREAS , University is the owner of certain Patent
Rights (as later defined herein) invented by University employees
Charles Dinarello, Eli Lewis and Leland Shapiro 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:
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“Affiliate(s)” shall mean every
corporation or entity, which, directly or indirectly, or through
one 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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"Associate(s)"
means any University employee working under the direction,
supervision, and/or control of the Investigator(s).
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"Investigator(s)" means Dr. Charles Dinarello
and/or Dr. Leland Shapiro, as long as each Investigator remains
employed by University.
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“Fields of Use” shall mean the
fields of use identified in Exhibit A .
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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 Investigator(s) for the life of the agreement or
Associate(s) for a period of three (3) years from the Effective
Date.,
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“Know-How” shall mean University's
proprietary information which has been created, developed, and
fixed in any tangible medium of expression by the Investigators
or
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Exclusive
License – APRO Bio
Pharma
CU 1268H and
CU1778H
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Associates and
which is directly related to the practice of the licensed Patent
Rights, including, but not limited to, technical information,
specifications, standards, devices, models, techniques, processes,
methods, formulae, documents, drawings and materials ("Technical
Information"). Know-How specifically includes, without
limitation, any Technical Information that relates to the discovery
of the underlying technology covered by the Patent
Rights.
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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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“Licensed
Product(s)” shall mean any:
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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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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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product
produced, discovered, manufactured or created through the use of
any Licensed Product defined in §1.8(a) or
§1.8(b).
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“Net
Sales” shall mean the total gross receipts for sales of
Licensed Products or practice of Licensed 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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“Patent
Rights” shall mean all of the following University
intellectual property and any utility applications, 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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the United
States and foreign patents and/or patent applications and/or
provisional patent applications listed in Exhibit 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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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 listed in
Exhibit B ;
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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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any reissues of
United States patents described in this Subsection.
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Exclusive
License – APRO Bio
Pharma
CU 1268H and
CU1778H
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“Territory” shall mean the
geographical area identified in Exhibit A
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SECTION
2. GRANT OF LICENSE
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University
hereby grants and Licensee and Affiliates accept, during the term
and subject to the terms and conditions of this
Agreement
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a nonexclusive,
royalty-bearing license to use the Know-How in the Territory and
within the Fields of Use; and
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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.
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All Know-How
due under this Agreement shall be delivered to Licensee prior to or
on the Effective Date in written, oral or other form of
communication. University shall use commercially reasonable efforts
to ensure that Licensee is provided with all Know-How due under
this Agreement.
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Notwithstanding
the terms as set forth in Section 2.2, if, at any time during the
Term of this Agreement University discovers Know-How that should
have been provided pursuant to Section 2.2, University shall
promptly provide written notification to Licensee of the omission
and provide any such Know-How due under Section 2.2 to Licensee
within thirty days of such written notice.
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Notwithstanding
the terms as set forth in Section 2.2, if, at any time during the
Term of this Agreement, Licensee discovers Know-How that should
have been provided pursuant to Section 2.2, Licensee shall request
the Know-How in writing from University and University shall
provide any such Know-how due under Section 2.2 to Licensee within
thirty days of the written request.
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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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The license
grant pursuant to Section 2.1 shall remain in effect regardless of
any change in status of the Investigators, including without
limitation, absence or withdrawal of one or both Investigators from
further development or execution of the Patent Rights.
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SECTION
3. IMPROVEMENTS & INDEPENDENT
INVENTIONS
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Improvements : In the event that University
develops any Improvements to the inventions claimed in the Patent
Rights, then each such Improvement will be considered part of this
Agreement for no additional consideration.
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Provided that
the Investigator(s) is/are at the time obligated to assign
intellectual property to University and is/are involved as
employee(s), board member(s), consultant to or 10% or greater
shareholder of Licensee, in the event that the Investigator(s) or
any Associate(s), make 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
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Exclusive
License – APRO Bio
Pharma
CU 1268H and
CU1778H
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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. .
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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
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Licensee may
sublicense to one or more third parties, the rights granted in
Section 2 subject to the following limitations:
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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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Licensee agrees
that, in the event University terminates this Agreement pursuant to
Subsection 13.2(b), any sublicenses granted shall be directly
enforceable by University;
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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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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.
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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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Licensee agrees
to forward to University a copy of each fully executed sublicense
agreement postmarked within thirty (30) days of the execution of
such agreement.
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Exclusive
License – APRO Bio
Pharma
CU 1268H and
CU1778H
SECTION
5. RETAINED RIGHTS
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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. §§ 200-204, et
seq., (“Bayh-Dole Act”) and 37 C.F.R. 401, as such may
be amended.
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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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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
avoid the loss of any Patent Rights or any other intellectual
property that Licensee does not want disclosed, as a result of such
activities and takes reasonable steps to avoid disclosure of
Know-How.
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University
recognizes the need for Licensee to protect any information and
Know-How included in the Patent Rights. University shall
have the right to publish any information included in the Patent
Rights and the Know-How provided that University, prior to
submission to a third party for publication of any information or
Know-How included in the Patent Rights ("Proposed Submission"),
provides written notice of any Proposed Submission to Licensee,
such written notice to include specifics regarding the information
to be disclosed in the Proposed Submission and a copy of the
Proposed Submission. Licensee shall have twenty (20)
days to review the Proposed Submission and provide to the
University written approval or disapproval for the Proposed
Submission. If Licensee disapproves the Proposed
Submission, the Parties have thirty (30) days from the date of the
written notice to negotiate terms for submission. In the
event that the Parties, at the expiration of this thirty (30) day
period, fail to agree upon terms for submission, then the dispute
will be resolved in accordance with Section 14.7 herein.
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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 make a reasonable effort to
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
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As
consideration for the grant of rights under this
Agreement,
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Licensee agrees
to pay to University a nonrefundable and non-creditable license fee
as set forth in Exhibit C .
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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
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Exclusive
License – APRO Bio
Pharma
CU 1268H and
CU1778H
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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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Licensee agrees
to pay University royalties as set forth in Exhibit C
;
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No multiple
royalties shall be payable because any Licensed Products or
Licensed Processes are covered by more than one of the Patent
Rights.
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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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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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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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All payments to
Colorado are in United States Dollars, made payable to “The
Regents of the University of Colorado” and mailed
to:
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Office of Technology Transfer
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University of Colorado, 588 SYS
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Suite 100, 4740 Walnut Street
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ATTN:
Accounts Receivable
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SECTION
7. REPORTS, RECORDS, AND AUDITS
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Licensee shall,
without request by University, within sixty (60) days following the
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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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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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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Licensee shall
keep accurate records and shall compel its Affiliates and
sublicensees to keep accurate records, in sufficient detail to
reflect its operations
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Exclusive
License – APRO Bio
Pharma
CU 1268H and
CU1778H
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under this
Agreement and to enable the royalties accrued and payable under
this Agreement to be determined.
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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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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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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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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
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Both University
and Licensee (hereinafter, “Party” or
“Parties”) shall vigilantly protect the confidential
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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All written
documents containing confidential information and other material in
tangible form received 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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Licensee
acknowledges that University is subject to the Colorado Open
Records Act (C.R.S. § 24-72-201, et seq.). All
plans and reports marked “Confidential” shall be
treated by University as confidential to the extent permitted under
§ 24-72-204.
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SECTION
9. LICENSEE DUE DILIGENCE OBLIGATIONS
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Licensee shall
use commercially reasonable efforts to bring Licensed Products and
Licensed 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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Licensee
acknowledges and agrees to the performance and diligence Milestones
defined in Exhibit E,
provided however
, that specific dates for such
milestones may be adjusted if required due to developments beyond
the reasonable control of Licensee. It may be necessary to repeat
or redesign an experiment (defined for the purpose of this Section
9.2
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Exclusive
License – APRO Bio
Pharma
CU 1268H and
CU1778H
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as
"Experimental Delays"). Unive
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