University of Colraod Stamp]]
Exhibit
10.8
[[University of Colraod Stamp]]
This
Exclusive License Agreement (the "Agreement") is made and entered
into this 00xx Xxxxx,
0000, (xxx "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 MaxCure Pharmaceuticals, Inc., a Colorado corporation having its principal office at 0000 X.
Xxxxxx Xxxxxx, Xxxxx 000, Xxxxxxxxx Xxxxxxx, XX 00000 (hereinafter "Licensee") (together
referred to as "Parties").
WHEREAS,
University is the owner of
certain Patent Rights (as later defined herein) relating to University Case No.
CU9014H, developed by University employee Xxxxxx Xxxxxxx; University Case No.
CU1428H developed by Xxxxxx Xxxxxxx and Xxxxxxx X. Xxxx; and University Case No. CU1697H, developed by 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:
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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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"Associate(s)"
means any individual working under the direction, supervision, and/or
controlof the
Investigator(s).
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1.3
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"Investigator(s)"
means Xx. Xxxxxx Xxxxxxx and/or Xx. Xxxxxxx X. Xxxx, as long as
eachInvestigator
remains employed by University.
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1.4
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"Fields of
Use" shall mean the fields of use identified inExhibit
A.
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1.5
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"Improvement"
shall mean any invention, the practice of which would also require
thepractice 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) or
Associate(s).
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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, including, but not limited
to, technical information, specifications, standards, devices, models,
techniques, processes, methods, formulae, documents, drawings and
materials ("Technical Information"), as well as all information,
knowledge, assistance, trade practices and secrets, and improvements
thereto, divulged, disclosed, or in any way communicated to Licensee under
this Agreement, unless such information was, at the time of disclosure, or
thereafter becomes a part of the general knowledge or literature which is
generally available for public use from other lawful sources and which is
directly related to the use of, or desirable for the practice of, or
assists in the use or practice of, the licensed Patent Rights. Know-How
specifically includes, without limitation, any Technical Information that
relates to the discovery of the underlying technology covered by the
Patent Rights and any Technical Information including without limitation,
any publications, patents and/or patent applications that may preclude or
interfere with Licensee's rights to develop, execute or commercialize 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
wholeor 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)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)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)product
produced, discovered, manufactured or created through the use of any
Licensed Product defined in §1.9(a) or
§1.9(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 ofLicensed
Processes by or on behalf of Licensee, and its Affiliates, 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, and its Affiliates, for the sale,
lease, or transfer of Licensed Products or Licensed
Processes.
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1.10
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"Patent
Rights" shallmean
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
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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.the United
States and foreign patents and/or patent applications and/or provisional
patent applications listed in Exhibit
B;
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b.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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x.xxxxxx 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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x.xxxxxx 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.any
reissues of United States patents described in this
Subsection.
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1.11 "Territory"
shall mean the geographical area identified in Exhibit
A.
1.12
"Commercial Sale" shall mean sale of Licensed Product to a purchaser other
than non-profit research institutions purchasing for research purposes and
Governmental agencies.
SECTION 2. GRANT OF
LICENSE
2.1 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.a
non-exclusive, royalty-bearing license to use the Know-How in the
Territory and within the Fields of Use;
and
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b.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
in the possession of University as of the Effective Date shall be
delivered toLicensee
prior to or on the Effective Date in written, oral or other form of
communication. University shall its best 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
thisAgreement,
University discovers Know-How that should have been provided pursuant to
Section 2.2, University shall promptly notify 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
thisAgreement,
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 underany 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 instatus 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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2.7
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In the event
that one or both Investigators are withdrawn from further development
orexecution of
the Patent Rights, Licensee reserves the right to select an appropriate
replacement, the replacement to be selected at Licensee's
discretion.
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SECTION 3. IMPROVEMENTS
& INDEPENDENT INVENTIONS
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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.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 Associates make any invention
in the Fields 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.
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x.Xxxxxxxxxx
shall disclose each Independent Invention to Licensee in reasonable
written detail after the University's Technology Transfer Office receives
notification from the Investigator(s) that such Independent Invention has
been made, and Licensee shall have ninety (90) days following written
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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4.1
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Upon prior
written approval by University, such approval not to be unreasonably
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 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
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5.1
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Government
Rights:
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a.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.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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x.Xxxxxxxxxx
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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x.Xxxxxxxxxx
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
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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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x.Xxxxxxxxxx
shall have the right to respond to any requests received in response to
any Proposed
Submissions submitted to a third party for publication under Section
5.2(b), provided that University, prior to response to any request,
provides written notice of any response ("Proposed Response") to Licensee,
such written notice to include specifics regarding the information to be
disclosed in the Proposed Response, and a copy of the Proposed Response,
the Proposed Response not to exceed 4 pages in length. Licensee shall have
ten (10) days to review the Proposed Response and provide to the
University written approval or disapproval for the Proposed Response. If
Licensee disapproves the Proposed Response, 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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SECTION 6. FEES &
ROYALTIES
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6.1
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As
consideration for the grant of rights under this
Agreement,
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a.Licensee
agrees to pay to University a nonrefundable and non-creditable license fee
as set forth in Exhibit
C.
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b.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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c.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
LicensedProcesses 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
thanarm'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.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.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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Office of
Technology Transfer
University of
Colorado,
000 XXX Xxxxx 000,
0000 Xxxxxx Xxxxxx
Xxxxxxx, XX
00000
ATTN: Accounts
Receivable
SECTION 7. REPORTS, RECORDS,
AND AUDITS
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7.1
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Reports:
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a.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.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.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.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.Such
records shall be retained for at least three (3) years after the close of
theperiod 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.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.
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.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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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
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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. It may be necessary to repeat or redesign
an experiment (defined for the purpose of this Section 9.2 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. No additional changes to the dates
of such Milestones
will be made without the written consent, which will not be unreasonably
denied, of
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
programto
commercialize Licensed Products and Licensed Processes in any Fields of
Use or Territory that Licensee decides not to exploit for its own
benefit.
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SECTION
10. PATENT
ADMINISTRATION
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10.1
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Licensee
shall reimburse University within thirty (30) days from the Effective Date
anamount
representing all patent expenses incurred by University prior to the
Effective Date as set forth in Exhibit
C.
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10.2
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Licensee
Rights:
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a. 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
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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.
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.Licensee may request that
University assume primary responsibility for all patentactivities,
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)
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) University shall
consult with Licensee in such prosecution and maintenance, hall
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. No claims of the Patent
Rights shall be modified, deleted, or abandoned by icensee 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).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).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. 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
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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
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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
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 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
for infringement of the Patent Rights against such third party in
accordance with the
following:
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a.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.
|
|
|
x.Xxxxxxxxxx
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.
|
|
|
x.Xx 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.
|
|
|
d.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.
|
|
|
x.Xx 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 (as that term
is
|
Page 10
of 26
|
|
defined 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 Sublicensing Royalties, as defined in
Exhibit C herein, 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 Licensee's expenses
and reasonable 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 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;
|
|
|
x.xx 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 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
|
Page 11
of 26
|
|
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. |
|
|
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.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:
|
|
|
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, (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.
|
|
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, (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.
|
|
12.4
|
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.
|
Page 12
of 26
SECTION
13. DURATION, TERMINATION, AND CONVERSION
|
13.1
|
ThisAgreement
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 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
undisputed 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.
|
|
|
x.Xxxxxxxxxx
may terminate this Agreement in the event
that:
|
|
|
(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
|
|
|
(iii).Licensee
is in breach or default of this Agreement other than those occurrences
listed in this Subsections (i) and (ii), 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.
|
Page 13
of 26
|
|
(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. Licensee may not assign its
rights in this Agreement without prior written approval by University,
such approval not to be unreasonably withheld or delayed. Notwithstanding
the foregoing, with respect to the proposed agreement between Apro Bio
Pharmaceutical Corporation and MaxCure Pharmaceuticals, Inc., University
accepts in advance and hereby acknowledges that the License Agreement may
be assigned to and will inure to the benefit of the surviving Colorado
Company.
|
|
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. Xxxxx X.
Xxxxx
|
|
Office of
Technology Transfer
|
President
|
|
University of
Colorado, 588 SYS
|
MaxCure
Pharmaceutical, Inc.
|
|
Xxxxx 000,
0000 Xxxxxx Xxxxxx
|
0000 X.
Xxxxxx Xxxxxx, Xxxxx 000
|
|
Xxxxxxx, XX
00000-0000
|
Xxxxxxxxx
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.
|
Page 14
of 26
|
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.Use best
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.
|
|
|
c.Use best
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
|
Page 15
of 26
|
|
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.
|
Page 16
of 26
IN WITNESS WHEREOF the parties
hereto have caused this Agreement, to be executed in duplicate by their
respective duly authorized officers.
|
University:
|
Licensee:
|
|
/s/ Xxxxx
X. Xxxxx
|
/s/ Xxxxx
X. Xxxxx
|
|
By:
Xxxxx X. Xxxxx
|
By: Xxxxx
X. Xxxxx
|
|
Title:
Associate VP for Technology Transfer
|
Title:
President and CEO
|
|
Date: March
31, 2009
|
Date: March
31, 2009
|
|
Office of
Technology Transfer
|
MaxCure
Pharmaceutical, Inc.
|
|
University of
Colorado, 588 SYS
|
0000 X.
Xxxxxx Xxxxxx, Xxxxx 000
|
|
Xxxxx 000,
0000 Xxxxxx Xxxxxx
|
Xxxxxxxxx
Xxxxxxx, XX 00000
|
|
Xxxxxxx, XX
00000-0000
|
|
Page 17
of 26
EXHIBIT
A
FIELDS
OF USE and TERRITORY
Fields
of Use: use of alpha-1 antitrypsin, and any analogs thereof, including
but not limited to synthetic analogs, alpha-1 antitrypsin derivatives, alpha-1
antitrypsin fragments, combinations with alpha-1 antitrypsin and modifications
of alpha-1 antitrypsin, for the prevention
and/or treatment
including prophylaxis of, reduction of and/or reduction of symptoms related to
any and all viral infections.
Treatment of all
viral infections including, without limitation, any and all mutations, strains,
and subtypes, including future mutations, strains, and subtypes of: Human
Immunodeficiency Virus (HIV) (including any viral infections reasonably and/or
previously withheld by the University, when they become available); Human
Papilloma Virus (HPV); Herpes Simplex Virus (HSV); Hepacivirus; Pestivirus;
Avian influenza virus; Human influenza virus; Xxxxxx Valley encephalitis; St.
Louis encephalitis.
In
addition, viruses that may or may not be used as bio-terrorist agents, for
example, without limitation:
I.Category
A
1. Variola
major (smallpox), CalPox, and other related pox viruses
2. Viral
hemorrhagic fevers
a.
Arenaviruses
i.LCM, Junin virus,
Machupovirus, Guanarito virus
ii.Lassa
Fever
b.
Bunyaviruses
i.
Hantaviruses
ii. Rift Valley
Fever
c.
Flaviviruses
i.
Dengue
d.
Filoviruses, including all viruses of the family Filoviridae
i.
Ebola
ii.
Marburg
e.
Togavirus
f.
Rhabdovirus
g.
Paramyxovirus
h.
Orthomyxovirus
i.
Arenavirus
j.Retrovirus
k.
Hepadnavirus I.Picornavirus
m. Reovirus
n.Papovavirus
o.Parvovirus
Page 18
of 26
p.
AdenovirusI
I
Category B
|
|
1.
|
Food and
Waterborne Viruses
|
a. Viruses (Caliciviruses, Hepatitis
A, Hepatitis C)
|
|
2.
|
Additional
viral encephalitides
|
a.West Nile
Virus
b.LaCrosse
c.California
encephalitis
d.VEE
e.EEE
f.WEE
g.
Japanese Encephalitis Virus
h.
Kyasanur Forest Virus
i.
Alkhurma hemorrhagic fever
j.
Tick-borne encephalitis
Ill.Category
C
1. Emerging
infectious disease threats such as Nipah virus and additional hantaviruses.
a.Tickborne
hemorrhagic fever viruses
b.Crimean-Congo
Hemorrhagic fever virus
c.Tickborne
encephalitis viruses
d.Yellow
fever
e.Rabies
virus
f.Chikungunya
virus
g.Severe acute
respiratory syndrome associated coronavirus (SARS-CoV)
-
Territory:
worldwide.
Page 19
of 26
EXHIBIT
C
PATENT
RIGHTS
|
·
|
U.S.
Patent No. 6,846,605 "Inhibitors of serine protease activity, methods and
compositions for the treatment of viral infections" (related to Xxxx #
XX0000X).
|
|
·
|
U.S.
Patent Application No. 11/044,224 "Inhibitors of serine protease activity,
methods and compositions for the treatment of viral infections"
(Continuation application of Patent No.
6,846,605).
|
|
·
|
Provisional
Patent Application No. 60/742,191 "Alpha-1-antitrypsin inhibition of
disease and conditions mediated by binding to cell-associate actin"
(related to Xxxx # XX0000X)
|
|
·
|
Provisional
Application No. 60/913,174 Title: Compositions and Methods of Use for
AlphaAntiTrypsin Having No Significant Serine Protease Inhibitor
Activity (CU1697H US)
|
|
·
|
PCT
Application No, PCT/US2006/061577 Title: Compositions and Methods For
Treating Actin-Mediated Conditions
(CU1428H)
|
|
·
|
U.S.
Patent Application No.11/719,200 "Compositions and Methods For Treating
Actin- Mediated Conditions" (CU1428H
US1)
|
Page 20
of 26
EXHIBIT
C
ROYALTIES
In
accordance with Section 6, Licensee shall pay the following royalties to
University: Patent
expenses: (still need to get this number)
Sublicensing
royalties as follows:
|
License
fee:
|
Shares of
Company's common stock representing four percent (4%) of the fully diluted
issued and outstanding shares of Company, which percentage shall be
non-dilutable through sale and issuance by Company of equity securities
having an aggregate investment purchase price of five million dollars
($5,000,000), to be conveyed to University License Equity Holdings, Inc.
(ULEHI), pursuant to a stock transfer agreement in a form mutually agreed
upon between the Parties. In the event that Company is merged into a
successor company prior to the execution of the License Agreement, ULEHI
shall be issued the number of shares in the successor company that
ULEHI would have received had it held 4% of Company's common stock
immediately prior to the merger.
|
|
Earned
Royalty:
|
Four percent (4%) of Net Sales (as defined herein). In the event that Licensee or its Affiliates must enter into a license with a third party and agrees to pay a royalty thereunder in order to make, use, or sell a Licensed Product(s) or Licensed Process(es), the Earned Royalty applicable to Net Sales for a given reporting period shall be reduced by fifty percent (50%) of the royalty paid to such third party(ies) during the same reporting period, but in no event shall the Earned Royalty be less than two percent (2%). |
|
Minimum
annual royalty:
|
Fifty
thousand dollars ($50,000) payable on the first business day of each
calendar year following the date proceeds of the first Commercial Sale of
Licensed Product are actually received by Licensee. The minimum annual
royalty shall be creditable against any Earned Royalties due for the same
calendar year.
|
|
Milestone
royalties per indication
are as
follows:
|
With respect
to the completion of any phase III clinical trial for any Licensed
Product, one hundred thousand dollars ($100,000), payable within thirty
(30) days of completion of such clinical trial.
With respect
to the first Commercial Sale of any Licensed Product, one hundred and
fifty thousand dollars ($150,000) payable within thirty (30) days of the
first Commercial Sale.
No payments
shall be due for the first indication. 100% shall be due for the second
indication. 50% shall be due for each subsequent indication.
Thirty
percent (30%) of all Sublicense income received during the first year
after the Effective Date.
Twenty-Five
percent (25%) of all Sublicense income received during the second year
after the Effective Date.
Twenty
percent (20%) of all Sublicense income received during the third year
after the Effective Date and each year thereafter until this Agreement is
terminated or expires.
Sublicense
income shall include any and all consideration received by Licensee from a
Sublicensee as consideration for the grant of a sublicense to the Patent
Rights or Know-l-low, including without limitation upfront fees,
maintenance fees, milestone payments, and minimum annual royalties.
Sublicense income shall also include the fair market value of any non-cash
consideration paid to Licensee for sublicense
rights.
|
Page 21
of 26
|
Expiration of
Royalties: |
Earned
Royalties payable hereunder with respect to each Licensed Product or
Licensed Process shall expire and terminate on the respective expiration
date of the last to expire of the Patent Rights applicable to each such
Licensed Product or Licensed Process.
|
|
|
|
Page 22
of 26
EXHIBIT
D
FORM
OF ROYALTY REPORT
| Licensee: __________________________________ | Case No.: _______________________________ |
| Investigator: ________________________________ | Patent No. _______________________________ |
| Period Covered: From: Through:____ / _____/______ | Date: ___________________________________ |
| Prepared By: _______________________________ | Date: ___________________________________ |
| Approved By: _____________________________ | |
If
license covers several major product lines, please prepare a separate report for
each line. Then combine all product lines into a summary report.
Report
Type: _________________ Single Product Line Report:
_________________ Multiproduct
Summary Report.
Page
1 of _____ PagesProduct
Line Detail._________ Line: _______ Trademark:
_______ Pages: _____
|
Period
Royalty Amount
|
||||||
|
Country
|
Gross
Sales
|
*
Less Allowances
|
Net
Sales
|
Royalty
Rate
|
This
Year
|
Last
Year
|
|
U.S.A.
|
||||||
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Canada
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||||||
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Europe
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Japan
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Other
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Other
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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.
Page 23
of 26
EXHIBIT
E
PERFORMANCE
MILESTONES
Milestones are
defined for the first indication
| IND submission |
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 ninety
(90) 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 Patent Rights and Know-How;
and
|
|
|
(b)
|
Within twelve
(12) months of execution of the Agreement the Licensee will have raised at
least five hundred thousand dollars ($500,000) through third party
investments directed to the development of the Patent
Rights.
|
|
2.
|
Within 60
days of the Effective Date (First Option Period), Licensee will negotiate
with University in an effort to enter into a Sponsored Research Agreement
in the Fields of Use for the benefit of Investigator(s) of as much as five
hundred thousand dollars ($500,000), the work plan of such sponsored
research to be mutually agreed upon by Licensee and University. University
hereby acknowledges that for Licensee to agree, any such plan of sponsored
research must be reasonably advantageous to Licensee and its efforts to
obtain commercialization of Licensed Product. In the event that the
Parties reach an agreement during the First Option Period, Licensee
reserves the right to raise the funds for the sponsored research for a
period of 4-6 months after entering into the Sponsored Research Agreement.
In the event that the Parties cannot reach an agreement during the First
Option Period, Licensee shall, within ten days of the end of the First
Option Period, provide notice of such failure to University. For a period
of 6 months of the date of the notice of failure to reach an agreement
(Second Option Period), the Parties agree to negotiate in good faith to
reach mutually agreed upon terms in an effort to enter into a Sponsored
Research Agreement. In the event Parties reach an agreement during the
Second Option Period, Licensee reserves the right to raise the funds for a
period of 4-6 months after entering into the Sponsored Research Agreement.
If the Parties fail to reach an agreement within the Second Option Period,
Licensee is no longer under an obligation to negotiate a Sponsored
Research Agreement in the Fields of
Use.
|
Page 24
of 26
FIRST
AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT
This
First Amendment (the "First Amendment") is between the Regents of the
University of Colorado (the "University"), a body corporate, having its
principal place of business at 0000 Xxxxx Xxxxxx, 0xx xxxxx, Xxxxxx, XX 00000,
and Apro Bio Pharmaceuticals Colrporation, formerly MaxCure Pharmaceuticals,
Inc., a Colorado corporation having its principal office at 0000 X.
Xxxxxx Xxxxxx, Xxxxx 000, Xxxxxxxxx Xxxxxxx, XX 00000 (hereinafter “Licensee”)
(together referred to as "Parties").
WHEREAS the University and Licensee entered into an License Agreement on
March 31, 2008, (the "Agreement");
WHEREAS,
University is the owner of certain Patent Rights (as later defined herein)
relating to University Case No. CU9014H, developed by University employee Xxxxxx
Xxxxxxx; University Case No. CU1428H developed by Xxxxxx Xxxxxxx and Xxxxxxx X.
Xxxx; and University Case No. CU1697H, developed by Xxxxxx Xxxxxxx and has the
right to grant licenses under said Patent Rights,
and;
WHEREAS,
Licensee is interested in 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;
WHEREAS
the Agreement have Diligence Milestones in Exhibit E and the parties desire to
amend one milestone;
WHEREAS
the Company is still making good-faith efforts toward development of commercial
applications that incorporates the Intellectual Property Rights and/or Know
How;
NOW,
THEREFORE, the parties agree to the following
change:
1. EXHIBIT
E
Diligence
Milestones – Section 2, should read as follows
“Licensee will
negotiate with University in an effort to enter into a Sponsored Research
Agreement in the Fields of Use for the benefit of Investigator(s) of as much as
five hundred thousand dollars ($500,000), the work plan of such sponsored
research to be mutually agreed upon by Licensee and University on or before July
1, 2009. University hereby acknowledges that for Licensee to agree,
any such plan of sponsored research must be reasonably advantageous to Licensee
and its efforts to obtain commercialization of Licensed Product. If
the Parties fail to reach an agreement within three months, Licensee is no
longer under an obligation to negotiate a Sponsored Research Agreement in the
Fields of Use.“
2. All
other terms, definitions, and conditions of the Agreement shall remain in full
force and effect.
3. In
the event of a conflict between the Agreement and the First Amendment, this
First Amendment shall prevail. This First Amendment and the Agreement represent
the entire agreement between the parties concerning the subject matter hereof
and may only be modified by an amendment executed by the parties’ authorized
representatives.
Page 25
of 26
IN WITNESS WHEREOF, the
parties have signed or caused this Amendment to be signed as of the dates
indicated below.
|
University
|
Apro
Bio Pharmaceutical Corporation
|
|
By: /s/
Xxxxx
Xxxxx
|
By: /s/
Xxxxx
X.X
Xxxxxx
|
|
Xxxxx Xxxxx
|
Xxxxx X.X Xxxxxx
|
|
Assoc. VP Technology Transfer
|
Chairperson
|
|
Date: March
17, 2009
|
Date: March
17, 2009
|
Page 26
of 26
