Contract
Exhibit 10.9
[[University
of Colorado Stamp]]
This Exclusive License
Agreement (the “Agreement”) is made and entered into this 12th of
November, 2008, (the “Effective Date”) by and between the Regents of the
University of Colorado, a body corporate, having its principal office at 0000
Xxxxx Xxxxxx, 0xx Xxxxx,
Xxxxxx, XX 00000 (hereinafter “University”) and APRO Bio Pharmaceutical
Corporation, a Colorado corporation having a principal place of business at 0000
X. Xxxxxx Xx. #000, Xxxxxxxxx Xxxxxxx, XX 00000 (hereinafter
“Licensee”).
WHEREAS, University is the
owner of certain Patent Rights (as later defined herein) invented by University
employees Xxxxxxx Xxxxxxxxx, Xxx Xxxxx and 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
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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1.2
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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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1.3
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"Investigator(s)"
means Xx. Xxxxxxx Xxxxxxxxx and/or Xx. Xxxxxx Xxxxxxx, as long as each
Investigator remains employed by
University.
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1.4
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“Fields of Use” shall mean the fields of use identified in Exhibit A. |
1.5
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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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1.6
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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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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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1.7
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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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1.8
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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 §1.8(a) or
§1.8(b).
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1.9
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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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1.10
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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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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 listed 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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1.11
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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 to the terms and conditions of this
Agreement
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a.
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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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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.
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2.2
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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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2.3
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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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2.4
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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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2.5
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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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2.6
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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
3.1
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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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3.2
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Independent
Inventions:
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a.
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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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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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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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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 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.
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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. |
4.2
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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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SECTION
5. RETAINED RIGHTS
5.1
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Government
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. §§ 200-204, et seq., (“Xxxx-Xxxx Act”) 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 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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b.
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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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c.
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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
6.1
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As
consideration for the grant of rights under this
Agreement,
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a.
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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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b.
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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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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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c.
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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 Processes are covered by more than one of the Patent
Rights.
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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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c.
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Office of Technology Transfer
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University of Colorado, 000 XXX
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Xxxxx 000, 0000 Xxxxxx Xxxxxx
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Xxxxxxx, XX 00000
ATTN:
Accounts Receivable
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SECTION
7. REPORTS, RECORDS, AND AUDITS
7.1
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Reports:
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a.
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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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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
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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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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 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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8.2
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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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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 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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9.2
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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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as
"Experimental Delays"). University hereby recognizes that any
such Experimental Delays are beyond the reasonable control of
Licensee. In the event that Licensee's performance is adversely
affected by any such Experimental Delays, University shall take reasonable
steps to adjust the Milestones accordingly. Milestone dates can only be
adjusted by mutual agreement in a written amendment to this Agreement. No
additional changes to the dates of such Milestones will be made without
the written consent, which will not be unreasonably denied by
University. In the event that the Parties fail to agree upon
adjustment of the Milestones, then the dispute will be resolved in
accordance with Section 14.7
herein.
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9.3
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Licensee
agrees to use commercially reasonable efforts to develop a sublicensing
program to 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
an amount representing all patent expenses incurred by University prior to
the Effective Date as set forth in Exhibit
C.
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10.2 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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In
the event that Licensee fails to diligently control preparation, filing,
prosecution, and maintenance of any and all patent applications or patents
included in the Patent Rights after thirty (30) days' written notice by
University of any such failure, University may provide Licensee
with sixty (60) 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. Any such failure on behalf of
Licensee shall be determined by University, acting reasonably, with such
determination to be based on what would be commercially reasonable and
customary with respect to patent obligations and expectations for a
company of Licensee's size, financial status and position in the
marketplace. 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 any
suspected 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 through appeal) 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 Sublicense Revenue, as defined in Exhibit C, 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
for infringement 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 Section 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.
|
|
e.
|
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 Sublicensing
Royalty (as set forth in Exhibit C) 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 Sublicense Revenues, as defined in Exhibit C, and third any
remaining balance shall be paid to
Licensee.
|
|
f.
|
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
reasonable attorney's fees, provided however, that such reduction shall
not exceed fifty percent (50%) of the total royalty due to University in
any single calendar year.
|
11.3
|
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:
|
|
a.
|
defend
the suit in its own name, at its own expense, and on its own behalf for
presumably valid claims in the Patent
Rights;
|
|
b.
|
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
|
|
x.
|
xxxxxx
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
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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.
|
|
c.
|
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.
|
11.4
|
In
all cases, Licensee agrees to keep University reasonably apprised of the
status and progress of any
litigation.
|
SECTION
12. WARRANTIES, INDEMNIFICATIONS, AND INSURANCE
12.1
|
Representations. University
is the owner of the Patent Rights and has full right and authority to
enter into this Agreement.
|
12.2
|
Negation of
Warranties:
|
|
a.
|
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.
|
12.3
|
Licensee
Indemnification: Except
as set forth in Section 12.4, 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:
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a.
|
the
use by or on behalf of Licensee, its sublicensees, Affiliates, directors,
officers, employees, or third parties of any Patent Rights contrary to the
terms of this Agreement;
|
|
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
|
|
c.
|
any right or obligation of Licensee under this Agreement. |
With respect to Licensee’s indemnification provided for in this Section 12.3, the following provisions shall apply, Licensee shall (i) receive prompt notification from University in writing of any such Claims, and (ii) have full authority, information and assistance from University to defend such Claims. |
12.4
|
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 the expiration date of the last to expire patents within Patent
Rights.
|
13.2
|
Termination of Agreement: |
|
a.
|
Licensee
may terminate this Agreement at any time if University is in breach and
University 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, University shall not be deemed to be in default unless it fails to
diligently commence and pursue action to cure such default during such
thirty day period; or, if at any time the general premise of the research
related to the Patent Rights is proved invalid or, 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
|
|
(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.
|
|
b.
|
University
may terminate this Agreement in the event
that:
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(i)
|
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
|
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:
|
Licensee:
|
License
Administrator
|
Xx
Xxxxxx, CFO
|
Office
of Technology Transfer
|
APRO Bio Pharmaceutical
Corporation
|
University of
Colorado
|
0000 X. Xxxxxx Xx. #000
|
0000
Xxxxxx Xxxxxx, Xxxxx 000
|
Xxxxxxxxx Xxxxxxx,
XX 00000
|
Xxxxxxx, XX
00000
|
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 (a) Licensee may state that it has a license for
the Patent Rights from University; (b) Licensee may disclose as may be
required by law, regulation, judicial or administrative process or in
accordance with applicable professional standards, rules, or in connection
with any public or private offerings or disclosures required by law; or
(c) to the extent such information shall have otherwise become publicly
available (including, without limitation, any information filed with any
governmental agency and available to the public). Licensee further agrees
not to use the name of University or any University faculty member,
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.
|
Commercially
reasonable efforts to 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.
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|
c.
|
Commercially
reasonable efforts to 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). 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 use commercially reasonable efforts
to 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, 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, and its Exhibits and Addenda, 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.
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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,
12.3, 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.
|
Authorized
signatures are on the following page
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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:
|
Licensee:
|
||
By: |
/s/ Xxxxx X. Xxxxx
|
By: |
/s/
Xxxxx X. X. Xxxxxx
|
Name: |
Xxxxx
X. Xxxxx
|
Name: |
Xxxxx
X. X. Xxxxxx
|
Title: |
Associate
VP for Technology Transfer
|
Title: |
Chairman of the Board
|
Date:
|
|
Date:
|
|
Office
of Technology Transfer
|
APRO Bio Pharmaceutical
Corporation
|
||
University
of Colorado, 588 SYS
|
0000 X. Xxxxxx Xx. #000
|
||
0000
Xxxxxx Xxxxxx, Xxxxx 000
|
Xxxxxxxxx
Xxxxxxx, XX 00000
|
||
Xxxxxxx,
XX 00000-0000
|
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EXHIBIT
A
FIELDS
OF USE and TERRITORY
- Fields of use:
prevention and treatment of graft rejection and promotion of graft
survival.
- 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 Graft Rejection And Promotion Of Graft Survival” PCT Patent
Application filed on June 7, 2006, CU TTO File No.
CU1268H
|
2.
|
“Methods
and Compositions for Treatment of Graft Rejection and Promotion of Graft
Survival,” Continuation in part filed on July 22, 2008, CU TTO File No.
CU1778H.
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EXHIBIT
C
ROYALTIES
In accordance with Section
6, Licensee shall pay the following to University:
Patent
expenses:
|
Thirty
four thousand seven hundred seventeen dollars ($34,717), plus additional
costs attributable to any other patent expense related to University case
#CU1268H and CU1778H in an amount not to exceed fifteen thousand dollars
($15,000).
|
License
fee:
|
To
be issued within thirty (30) days of the Effective Date: shares of
Licensee's common stock representing two percent (2%) of all outstanding
shares of capital stock of Licensee on a fully diluted basis at the
closing of Licensee’s planned reverse merger, which calculation shall
include all Placement Agent Warrants, Units, and Shares issued in
connection with the closing of the merger, as described in the merger term
sheet. The shares shall be issued to University License
Equity Holdings, Inc., a Colorado nonprofit corporation ("ULEHI"),
pursuant to ULEHI's standard form stock subscription
agreement.
|
Minimum
annual royalty:
|
Fifty
thousand dollars ($50,000) payable for each calendar year beginning the
calendar year after the first Commercial Sale. The minimum
annual royalty shall be creditable against earned royalties due on Net
Sales for the same calendar year. “Commercial Sale” shall mean sale of
Licensed Product to a purchaser other than non-profit research
institutions purchasing for research purposes.
|
Earned
royalty:
|
Three
percent (3%) of Net Sales by Licensee, Affiliates, or
sublicensees.
|
Milestone
royalties per indication are as follows:
|
|
Upon
the initiation of any phase II clinical trial for any therapeutic
indication, Licensee shall pay a one-time fee of twenty-five thousand
dollars ($25,000) within sixty (60) days of initiation of such clinical
trial. This milestone does not include clinical (off-label)
testing.
|
|
Upon
the initiation of any phase III clinical trial for any therapeutic
indication, Licensee shall pay a one-time fee of one hundred thousand
dollars ($100,000) within sixty (60) days of initiation of such clinical
trial. This milestone does not include clinical (off-label)
testing.
|
|
Upon
approval from the United States Food and Drug Administration (FDA), or
foreign equivalent, of any Licensed Product, Licensee shall pay two
hundred thousand dollars ($200,000) within sixty (60) days of such
approval. This milestone does not include FDA approval for
clinical (off-label) testing.
|
|
Sublicensing
royalties:
|
The
following percentages of consideration in any form received by Licensee or
Affiliates in connection with a grant to any third party of a sublicense
but excluding consideration included within Net Sales (“Sublicense
Revenue”). Sublicense Revenue shall include without limitation
upfront fees, maintenance fees, milestone payments, the unearned portion
of any minimum royalties, equity, and research and development funding in
excess of the costs of performing such research and
development.
|
Thirty
percent (30%) of all Sublicense Revenue received under sublicenses
executed during the first year after the Effective
Date.
|
|
Twenty-Five
percent (25%) of all Sublicense Revenue received under sublicenses
executed during the second year after the Effective
Date.
|
|
Twenty
percent (20%) of all Sublicense Revenue received under sublicenses
executed during the third year after the Effective Date and each year
thereafter until this Agreement is terminated or
expires.
|
|
|
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Expiration
of Royalties: |
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
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
|
Completion
by 12/31/2009
|
Phase
III initiation
|
Completion
by 12/31/2012
|
FDA
submission
|
Completion
by 12/31/2014
|
Market
launch
|
Completion
by 12/31/2016
|
DILIGENCE
MILESTONES
1.
|
Licensee
shall deliver to University:
|
|
(a)
|
within
four (4) months days of the Effective Date, a comprehensive business plan
that describes the Licensee’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
six (6) months of the Effective Date, evidence that Licensee has
received investment funding of at least one million dollars
($1,000,000)
|
2.
|
Licensee
shall, within six (6) months after the Effective Date, enter into a
sponsored research agreement for the benefit of Xx. Xxxxxxx Xxxxxxxxx as
Principal Investigator to support work related to development of Licensed
Products. The amount of such sponsored research shall be at
least $300,000 for the first year and at least $250,000 for each of the
following two years (i.e., a total minimum amount of $800,000 for three
years).
|
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