Exhibit 10.8
[[University of
Colraod Stamp]]
This
Exclusive License Agreement (the
"Agreement") is made and entered into this 31of March, 2008, (the
"Effective Date") by and between the Regents of the University of
Colorado, a body corporate, having its principal office at 1800
Grant Street, 8 th
Floor,
Denver, CO, 80203 (hereinafter "University") and MaxCure
Pharmaceuticals, Inc., a Colorado corporation having its principal
office at 5350 S. Roslyn Street, Suite 300, Greenwood Village, CO
80111 (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 Leland Shapiro; University Case No. CU1428H developed by
Leland Shapiro and Gregory B.
Pott; and
University Case No. CU1697H, developed by Leland Shapiro and has
the right to grant licenses under said Patent Rights,
and;
WHEREAS,
Licensee is
interested in licensing and further developing the Patent Rights
for commercial applications, and;
WHEREAS,
University
desires to have the Patent Rights developed and commercialized to
benefit the public and is willing to grant a license
hereunder;
NOW,
THEREFORE, in
consideration of the promises and the mutual covenants contained
herein, the parties hereto agree as follows:
SECTION 1.
DEFINITIONS
For the
purposes of this Agreement, the following words and phrases shall
have the following meanings:
|
1.1
|
"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.
|
|
1.2
|
"Associate(s)"
means any individual working under the direction, supervision,
and/or controlof the Investigator(s).
|
|
1.3
|
"Investigator(s)"
means Dr. Leland Shapiro and/or Dr. Gregory B. Pott, as long as
eachInvestigator remains employed by University.
|
|
1.4
|
"Fields of Use"
shall mean the fields of use identified in
Exhibit A.
|
|
1.5
|
"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).
|
|
1.6
|
"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.
|
|
1.7
|
"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.
|
|
1.8
|
"Licensed
Product(s)" shall mean any:
|
|
|
(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
|
|
|
(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
|
|
|
(c)product
produced, discovered, manufactured or created through the use of
any Licensed Product defined in §1.9(a) or
§1.9(b).
|
|
1.9
|
"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.
|
|
1.10
|
"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:
|
|
a.the United
States and foreign patents and/or patent applications and/or
provisional patent applications listed in Exhibit
B;
|
|
|
b.United States
and foreign patents issued from the applications listed in
Exhibit
B and from
divisionals and continuations of these applications;
|
|
|
c.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;
|
|
|
d.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
|
|
|
e.any reissues
of United States patents described in this Subsection.
|
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
|
|
a.a
non-exclusive, royalty-bearing license to use the Know-How in the
Territory and within the Fields of Use; and
|
|
|
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.
|
|
2.2
|
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.
|
|
2.3
|
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.
|
|
2.4
|
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.
|
|
2.5
|
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.
|
|
2.6
|
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.
|
|
2.7
|
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.
|
SECTION 3.
IMPROVEMENTS & INDEPENDENT INVENTIONS
|
3.1
|
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.
|
|
3.2
|
Independent
Inventions:
|
|
|
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.
|
|
|
b.University
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.
|
SECTION 4.
SUBLICENSING
|
4.1
|
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:
|
|
|
|
Licensee agrees
that any sublicenses granted by it shall impose restrictions and
conditions upon sublicensees equivalent in scope to those imposed
upon Licensee;
|
|
|
|
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;
|
|
|
|
Licensee agrees
that any sublicenses granted shall adequately protect University's
security and property interest in University's Know-How and Patent
Rights; and
|
|
|
|
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.
|
|
4.2
|
Licensee agrees
to forward to University a copy of each fully executed
sublicenseagreement postmarked within thirty (30) days of the
execution of such agreement.
|
SECTION 5.
RETAINED RIGHTS
|
|
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. §§ 200-204, et seq.,
("Bayh-Dole Act") and 37 C.F.R. 401, as such may be
amended.
|
|
|
b.Further,
Licensee agrees to take all reasonable action necessary to enable
University to satisfy its obligations hereunder.
|
|
|
a.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.
|
|
|
b.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.
|
|
c.University
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.
|
SECTION 6.
FEES & ROYALTIES
|
6.1
|
As
consideration for the grant of rights under this
Agreement,
|
|
|
a.Licensee
agrees to pay to University a nonrefundable and non-creditable
license fee as set forth in Exhibit
C.
|
|
|
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;
|
|
|
c.Licensee
agrees to pay University royalties as set forth in
Exhibit
C;
|
|
6.2
|
No multiple
royalties shall be payable because any Licensed Products or
LicensedProcesses are covered by more than one of the Patent
Rights.
|
|
6.3
|
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.
|
|
|
a.Unless
otherwise provided herein, all payments required under this
Agreement shall be due within thirty (30) days of written notice
from University.
|
|
|
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.
|
|
|
c.All payments
to Colorado are in United States Dollars, made payable to "The
Regents of the University of Colorado" and mailed to:
|
Office of
Technology Transfer
588 SYS Suite
100, 4740 Walnut Street
ATTN: Accounts
Receivable
SECTION 7.
REPORTS, RECORDS, AND AUDITS
|
|
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.
|
|
|
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.
|
|
|
c.Unless
otherwise agreed to by the Parties, the written report shall be in
the substantially the same form as Exhibit
D.
|
|
|
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.
|
|
|
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.
|
|
|
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.
|
|
|
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.
|
SECTION 8.
CONFIDENTIAL INFORMATION
|
8.1
|
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.
|
|
8.2
|
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.
|
|
8.3
|
Licensee
acknowledges that University is subject to the Colorado Open
Records Act(C.R.S. § 24-72-201, et seq.). All plans and
reports marked "Confidential" shall be treated by University as
confidential to the extent permitted under §
24-72-204.
|
SECTION
9 .
LICENSEE DUE
DILIGENCE OBLIGATIONS
|
9.1
|
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.
|
|
9.2
|
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 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.
|
|
9.3
|
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.
|
SECTION
10.
PATENT
ADMINISTRATION
|
10.1
|
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 .
|
|
|
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
|
|
|
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.
|
|
|
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:
|
|
|
|
(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.
|
|
|
(ii) University
shall consult with Licensee in such prosecution and maintenance,
hall diligently seek Licensee's advice on all matters pertaining to
the Patent Righ
|
|
