Attached files
Exhibit 10.3
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Internal
University Use Only
OTC
Agreement No.:
OTC
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Revision Date: |
University of
Minnesota
EXCLUSIVE PATENT LICENSE AGREEMENT
THIS EXCLUSIVE PATENT LICENSE AGREEMENT
(this “Agreement”) is made by and between Regents of
the University of Minnesota, a constitutional corporation under the
laws of the state of Minnesota, having a place of business at 200
Oak Street, SE, Suite 280, Minneapolis, Minnesota 55455 (the
“University”), and the Licensee identified below. The
University and the Licensee agree that:
The
Terms and Conditions of Exclusive Patent License attached hereto as
Exhibit A (the “Terms and Conditions”) are incorporated
herein by reference in their entirety. In the event of a conflict
between provisions of this Agreement and the Terms and Conditions,
the provisions in this Agreement shall govern. Capitalized terms
used in this Agreement without definition shall have the meanings
given to them in the Terms and Conditions. The section numbers used
in the parentheses below correspond to the section numbers in the
Terms and Conditions.
1.
Licensee (§1.8): Oxis Biotech,
Inc., a corporation under the laws of Delaware, having its
principal offices at 100 South Ashley
Drive, Suite 600 Tampa, FL 33602
2.
Field(s) of Use
(§1.3):
All
3.
Territory (§1.16): Any country or
territory where unexpired Licensed Patents exist.
4.
Effective Date (§2): Date of the
last signature of the Agreement.
FORM:
OGC-401
Exclusive
Patent License Agreement
Form
Date: 12.18.01
Revision
Date: 6/19/2016
1
5.
Licensed
Patents and Technical Information:
5.1 Patents(s)
(§1.4):
NONE
5.2
Patent Applications
(§1.5):
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Application
No.
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Country
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Filing
Date
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Title
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62/237,835
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USA
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October
6, 2015
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Therapeutic
compounds and its uses
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5.3
Technical
Information:
☒
None
6.
Patent-Related Expenses (§§1.10 &
6.3): The Licensee shall reimburse the University for
Patent-Related Expenses incurred before and during the Term as
provided in section 6.3 of the attached Terms and
Conditions.
7. Sublicense Rights (§3.1.2): [Select
one of the following]
2
8. Federal Government Rights (§3.2):
[Select one of the following]
☒
Yes
☐
No
9.
Performance Milestones (§5.1): The
Licensee shall achieve the following milestones:
➢
Perform First
dosing of first patient in a Phase I clinical trial for the
Licensed Product within 24 months from the Effective
Date;
➢
Perform the first
dosing of a patient in a Phase II clinical trial for the Licensed
Product within 48 months from the Effective Date.
➢
Perform the first
dosing of a patient in a Phase III clinical trial within 84 months
from the Effective Date;
➢
Obtain regulatory
approval for commercial sale of the Licensed Product in the
Territory within 120 months from the Effective Date.
By
March 1 of each year, Licensee will submit a written annual report
to University covering the preceding calendar year. The report will
include information sufficient to enable University to satisfy
reporting requirements of the U.S. Government and for University to
ascertain progress by Licensee toward meeting this
Agreement’s diligence requirement. Each report will describe,
where relevant: Licensee’s progress toward commercialization
of Licensed Product, including work completed, key scientific
discoveries, summary of work-in-progress, current schedule of
anticipated events or milestones, market plans for introduction of
Licensed Product, and significant corporate transactions involving
Licensed Product. Licensee will specifically describe how each
Licensed Product is related to each Licensed Patent.
10.
Commercialization Reports (§5.4):
On each anniversary of the Effective Date, the Licensee shall
deliver written commercialization reports to the University as
provided in section 5.4 of the Terms and Conditions.
11.
Payments (§6.1). All amounts are
non-refundable, and payable as defined below or as specified in the
University’s invoice.
11.1
Upfront Payment: $200,000 payable as
follows: $75,000 is payable within 15 calendar days after the
Effective Date. The remaining $125,000 is payable within 6 months
of the Effective Date of the Agreement. For clarification,
Licensee’s obligation to pay the full amount of $200,000
survives any termination by Licensee pursuant to Section 8.2 of the
Terms and Conditions and would be in addition to the early
termination fee set forth in Section 8.2 of the Terms and
Conditions
3
11.2
License Maintenance Fee.
➢
$25,000, payable on
the first and second anniversary of the Effective Date
➢
$50,000, payable on
the third and fourth anniversary of the Effective
Date.
➢
$100,000, payable
on the fifth anniversary of the Effective Date an on each
anniversary of the Effective Date thereafter.
11.3
Document Fee: None.
11.4
Running Royalties on Net Sales. Licensee
shall pay the University a royalty of four percent (4%) of Net
Sales of Licensed Product, determined and payable as provided in
section 6.4 of the Terms and Conditions. For clarification,
Licensee intends to sponsor research at the University which may
result in additional inventions, for which Licensee will have an
opportunity to negotiate a license. If Licensee develops products
which are covered by a Licensed Patent or Technical Information
under this Agreement and also is covered by the claims in a patent
for any inventions developed by the University, the maximum royalty
for which Licensee will be obligated to pay under a subsequent
license agreement or amendment to this Agreement will not exceed
6%.
11.5 Annual
Minimum. The annual minimum amount of Royalties owed by the
Licensee under subsection 11.4.1, upon commencement of commercial
sales, shall be $250,000 beginning in Year 2022; $2,000,000,
beginning in year 2025; and $5,000,000 beginning in year 2027
throughout the remainder of the term.).
11.5
Non-Royalty Sublicense
Consideration:
➢
Licensee shall pay
the University 50% of all Non-Royalty Sublicensee Consideration
received by Licensee prior to the initiation of a Phase I clinical
trial.
➢
Licensee shall pay
the University 25% of all Non-Royalty Sublicensee Consideration
received by Licensee after the initiation of a Phase I clinical
trial but prior to the initiation of a Phase III clinical
trial
➢
Licensee shall pay
the University 15% of all Non-Royalty Sublicensee Consideration
received by Licensee after regulatory approval of the first
Licensed Product for commercial sale in North America, the European
Union, Japan, or Australia.
11.8 Change
of Control Fee: One hundred fifty thousand dollars
($50,000.00), payable as provided in section 12.5 of the Terms and
Conditions.
4
11.9 Performance
Milestone Payments:
11.9.1 Clinical
Development Milestones:
➢
$100,000 upon
dosing of the first human subject in a Phase I clinical trial of a
Licensed Product;
➢
$250,000 upon
dosing of a first human subject in a Phase II clinical trial of a
Licensed Product;
➢
$500,000 upon
dosing of a first human subject in a Phase III clinical trial of a
Licensed Product;
➢
$500,000 upon
filing of an BLA with FDA (or EMEA or an equivalent authority in)
in any jurisdiction, for a Licensed Product;
➢
$1,000,000
following the first commercial sale of a Licensed
Product;
➢
$500,000 for the
second commercial sale of a Licensed Product.
➢
$250,000 for the
first commercial sale of a Licensed Product for any non-human
use.
11.9.2 Patent
issuance milestone:
➢
A one-time $50,000
payment due upon issuance of a Licensed Patent in any of Australia,
European Union, Japan, the U.S. or Canada including a valid claim
to a Licensed Product.
11.9.3 Sales
Milestones (one time):
➢
$1,000,000 upon
reaching 250 Million dollars in cumulative gross sales of Licensed
Products.
➢
$5,000,000 upon
reaching 500 Million dollars in cumulative gross sales of Licensed
Products.
11.7 Equity:
None
12.
Licensee’s Address for Notice
(§12.13). Notices will be sent to the Licensee
at:
Attn:
Anthony J. Cataldo
Chairman &
Chief Executive Officer
Oxis
Biotech, Inc.
4830
West Kennedy Boulevard, Suite 600
Tampa,
Florida 33609
Facsimile No.:
Email:
cataldo14@aol.com
5
13.
Licensee’s Contact Person for Patent
Prosecution Consultation (§4.2.1). The University will, as set forth
in this Agreement, communicate with the contact person named below
with respect to patent prosecution and maintenance: (Upon ten (10)
days prior written notice to the University, the Licensee may
change the person designated below.)
Lisa A.
Haile, J.D., Ph.D.
DLA
Piper LLP (US)
4365
Executive Drive, Suite 1100
San
Diego, California 92121
858.677.1456
T
858.735.2456
C
858.638.5040 F
lisa.haile@dlapiper.com
IN WITNESS WHEREOF, the parties hereto
have caused their duly authorized representatives to execute this
Agreement.
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Regents
of the University of Minnesota
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Oxis
Biotech, Inc
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By: /s/ Jay W.
Schrankler
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By: /s/ Anthony J.
Cataldo
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Jay W.
Schrankler
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Anthony J.
Cataldo
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Executive
Director
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Chairman &
Chief Executive Officer
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Office for
Technology Commercialization
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Date: July 15,
2016
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Date: July 18,
2016
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6
University of
Minnesota
EXHIBIT A
Terms and Conditions
Exclusive Patent License Agreement
These
terms and conditions to the Exclusive Patent License Agreement
(“Terms and Conditions”) govern the grant of license by
Regents of the University of Minnesota (“University”)
to the Licensee identified in the Exclusive Patent License
Agreement (the “EPLA”). These Terms and Conditions are
incorporated by reference into the EPLA. All section references in
these Terms and Conditions refer to provisions in these Terms and
Conditions unless explicitly stated otherwise.
1.
Definitions. For purposes of
interpreting this Agreement, the following terms have the following
meanings:
1.1
“Affiliate”
means an entity that controls the Licensee or the sublicensee, as
the case may be, is controlled by the Licensee or sublicensee, or
along with the Licensee or sublicensee, is under the common control
of a Third Party. An entity shall be deemed to have control of the
controlled entity if it (i) owns, directly or indirectly, fifty
percent (50%) or more of the outstanding voting securities of the
controlled entity, or (ii) has the right, power or authority,
directly or indirectly, to direct or cause the direction of the
policy decisions of the controlled entity, whether by ownership of
securities, by representation on the controlled entity’s
governing body, by contract, or otherwise.
1.2
“Change of
Control” means (A) acquisition of ownership -- either
directly or indirectly. by any person or group -- of the capital
stock of Licensee representing more than 50% of either the
aggregate ordinary voting power or the aggregate equity value
represented by the issued and outstanding capital stock of the
Licensee; and/or (B) the sale of all or substantially all the
Licensee’s assets and/or business in one transaction or in a
series of related transactions.
1.3
"Exclusive" means
that, subject to Sections 3.2 and 3.3, University will not grant
further licenses under the Licensed Patent or Licensed Patent
Applications in the Field of Use in the Territory.
1.3
“Field of
Use” means the field(s) of use described in section 2 of the
EPLA.
1.4
“Licensed
Patent” means the (i) the patent(s) described in section 5.1
and (ii) the patent applications described in Section 5.2 of the
EPLA, along with any issued and unexpired patent(s) issued during
the Term that arose out of and claim priority to such patent
applications, such as for example, continuations, divisionals,
continuation-in-part, or foreign applications. “Licensed
Patent” also means any reissues or reexaminations of a
Licensed Patent that contain one or more valid claims directed to
Licensed Technology. Any claim of an unexpired Licensed Patent is
presumed to be valid unless it has been held to be invalid by a
final judgment of a court of competent jurisdictions from which no
appeal can be or is taken.
A-1
1.6
“Licensed
Product(s)” means any product or part of a product in the
Field of Use:
(i)
the making, using,
importing or selling of which, absent this license, infringes,
induces infringement, or contributes to infringement of a Licensed
Patent; or
(ii)
which is made with,
uses, was derived from, identified or validated by, incorporates,
or was developed in whole or in part using any Technical
Information.
1.7
“Licensee”
means the entity identified in section 1 of the EPLA.
1.9 “Net
Sales” means all
gross derived by Licensee, its Affiliates, or sublicensees, their
distributors or designees from the sale, transfer or other
disposition of Licensed Product to an end user. Net Sales excludes
the following items: (i) all trade, quantity, and cash discounts
actually allowed, (ii) all credits and allowances actually granted
due to rejections, returns, billing errors, and retroactive price
reductions, (iii) applicable duties, and (iv) applicable excise,
sale and use taxes.
1.10 “Nonroyalty
Sublicensing Consideration” means any consideration received
by Licensee from a sublicensee other than (i) royalties on product
sales (royalties on product sales by sublicensees will be treated
as if Licensee made the sale of such product).
1.10
“Patent-Related
Expenses” means costs and expenses (including out-of-pocket
attorneys’ fees, patent agent fees and governmental filing
fees) that the University incurs in prosecuting and maintaining the
Licensed Licensed Patents.
1.11
“Performance
Milestone” means an act or event specified in section 5.1 and
described in section 9 of the EPLA.
1.16
“Territory”
means the geographical area described in section 3 of the
EPLA.
1.17
“Third
Party” means any party other than the University or
Licensee.
1.18
“University
Indemnitees” means University, its respective regents,
officers, employees, students, agents, faculty, representatives,
and volunteers.
2.
Term. The term of this Agreement
commences on the Effective Date as defined in section 4 of the EPLA
and, unless terminated earlier as provided in section 8, expires on
the date on which both no Licensed Patent is active in the
Territory and no Licensed Patent Application is pending in the
Territory (the “Term”).
A-2
3.
Grant
of License.
3.1
The
Licensee’s Rights.
3.1.1
Licensed Patent.
Subject to the terms and conditions of this Agreement, the
University hereby grants to the Licensee an Exclusive license
(sub-licensable if Section 7 of the EPLA is marked
“Yes”) under the Licensed Patent in the Field of Use to
make, have made, use, import, offer to sell and sell Licensed
Product in the Territory.
3.1.2
Technical
Information (unless “None” is selected in Section 5.3
of the EPLA). Subject to the terms and conditions of this
Agreement, the University hereby grants to the Licensee a
non-exclusive license to use the Technical
Information.
3.1.3
Specific Exclusion.
University does not grant any other rights under this Agreement
except as contained in Section 3.1.1 and 3.1.2. Except as may be
provided under Section 3.1.2, the University does not agree to
furnish to Licensee any technical information. Additionally, the
University has not agreed to provide Licensee with any assistance
under this Agreement.
3.2
The
University’s Retained Rights. The University retains on
behalf of itself and all other non-profit research institutions, to
practice the Licensed Patent for any non-profit purpose, including
research, teaching, and educational purposes. Licensee agrees that,
notwithstanding any other provision of this Agreement, it has no
right to enforce the Licensed Patent against any such institution
using the Licensed Patent for non-profit purposes.
3.3
Right of U.S. Government. [Applicable if Section 5 of the EPLA is
checked “Yes.”] This Agreement is subject to Title 35
Sections 200-204 of the United States Code. Among other things,
these provisions provide the United States Government with
nonexclusive rights in the Licensed Patent. They also impose the
obligation that the Licensed Product sold or produced in the United
States be “manufactured substantially in the United
States.” Licensee will ensure all obligations of these
provisions are met.
4.
Applications
and Patents.
4.1
Pre-EPLA Patent
Filings. The Licensee acknowledges that it has reviewed each
Licensed Patent and each Licensed Patent Application and that it
will not dispute the inventorship, validity, or enforceability of
any of the claims made in a Licensed Patent or a Licensed Patent
Application. The Licensee further represents that as of the
Effective Date, it has not and does not manufacture, have
manufactured, offer to sell, sell, offer to lease, lease, or import
(a) any product or good that infringes (including under the
doctrine of equivalents) a claim in any Licensed Patent or Licensed
Patent Application, or (b) any product or good that is made using a
process or machine that infringes (including under the doctrine of
equivalents) a claim in a Licensed Patent or Licensed Patent
Application.
A-3
4.2
Patent Application
Filings during the Term of this Agreement.
4.2.1
The University, in
consultation with the Licensee, shall determine in which countries
patent application(s) will be filed and prosecuted with respect to
the Licensed Technology. The University shall retain counsel of its
choice to file and prosecute such patent applications. The
University will inform the Licensee of the status of the
prosecution of the patent application, including delivering to the
Licensee pertinent notices, written and oral communications with
governmental officials, and documents, and shall consult with the
Licensee on the prosecution of the patent application. The Licensee
shall cooperate with the University in the filing and prosecution
of all patent applications with respect to the Licensed Technology.
In furtherance of the foregoing, the Licensee shall notify the
University, in writing, of the individual whom the Licensee has
designated to consult and cooperate as provided in this subsection
and is identified in section 13 of the EPLA. The Contact Person
shall respond to the University’s request for consultation
and cooperation on a pending matter within five business days or
sooner as may be required under the circumstances. If the Contact
Person fails to respond in such time period, the University,
exercising its own judgment and discretion, may respond to the
matter as it deems appropriate. Except as provided in subsection
4.2.2, the Licensee shall reimburse the University for all
Patent-Related Expenses as provided in section 6.3 and in section 6
of the EPLA.
4.2.2
The grant of
license in section 3.1 and the definition of Territory in section
1.16 shall not extend to or include any country in which Licensee
elects, in writing to the University, not to pay or reimburse the
payment of the cost, in whole or in part, to seek or maintain
intellectual property protection.
4.2.3
No provision of
this Agreement limits, conditions, or otherwise affects the
University’s right to prosecute a patent application with
respect to the Licensed Technology in any country. The University
retains the sole and exclusive right to file or otherwise prosecute
a patent application with respect to the Licensed Technology. In no
event shall the Licensee file a patent application with respect to
the Licensed Technology. The Licensee shall cooperate with the
University in the filing and prosecution of all patent applications
with respect to the Licensed Technology.
4.3
Rights in the
Licensed Patents and Licensed Patent Applications. No provision of
this Agreement grants the Licensee any rights, titles, or interests
(except for the grant of license in subsection 3.1.1) in the
Licensed Patents or Licensed Patent Applications, notwithstanding
the Licensee’s payment of all or any portion of the patent
prosecution, maintenance, and related costs.
A-4
5.
Commercialization.
5.1
Commercialization
and Performance Milestones. The Licensee shall use its commercially
reasonable efforts, consistent with sound and reasonable business
practices and judgment, to commercialize the Licensed Technology
and to manufacture and offer to sell and sell Licensed Products as
soon as practicable and to maximize sales thereof. The Licensee
shall perform, or shall cause to happen or be performed, as the
case may be, all the performance milestones described in section 9
of the EPLA.
5.2
Covenants Regarding
the Manufacture of Licensed Products. The Licensee hereby covenants
and agrees that (i) the manufacture, use, sale, or transfer of
Licensed Products shall comply with all applicable federal and
state laws, including all federal export laws and regulations; and
(ii) the Licensed Products shall not be defective in design or
manufacture. The Licensee hereby further covenants and agrees that,
pursuant to 35 United States Code Section 204, it shall, and it
shall cause each sublicensee, to substantially manufacture in the
United States of America all products embodying or produced through
the use of an invention that is subject to the rights of the
federal government of the United States of America.
5.3
Export and
Regulatory Compliance. The Licensee understands that the Arms
Export Control Act (AECA), including its implementing International
Traffic In Arms Regulations (ITAR,) and the Export Administration
Act (EAA), including its Export Administration Regulations (EAR),
are some (but not all) of the laws and regulations that comprise
the U.S. export laws and regulations. Licensee further understands
that the U.S. export laws and regulations include (but are not
limited to): (i) ITAR and EAR product/service/data-specific
requirements; (ii) ITAR and EAR ultimate destination-specific
requirements; (iii) ITAR and EAR end user-specific requirements;
(iv) Foreign Corrupt Practices Act; and (v) antiboycott laws and
regulations. The Licensee shall comply with all then-current
applicable export laws and regulations of the U.S. Government (and
other applicable U.S. laws and regulations) pertaining to the
Licensed Products (including any associated products, items,
articles, computer software, media, services, technical data, and
other information). The Licensee certifies that it shall not,
directly or indirectly, export (including any deemed export), nor
re-export (including any deemed re-export) the Licensed Products
(including any associated products, items, articles, computer
software, media, services, technical data, and other information)
in violation of U.S. export laws and regulations or other
applicable U.S. laws and regulations. The Licensee shall include an
appropriate provision in its agreements with its authorized
sublicensees to assure that these parties comply with all
then-current applicable U.S. export laws and regulations and other
applicable U.S. laws and regulations.
A-5
5.4
Commercialization
Reports. Throughout the Term and during the Post-termination
Period, and within thirty (30) days of the date specified in the
schedule set forth in section 10 of the EPLA, the Licensee shall
deliver to the University written reports of the Licensee’s
and the sublicensees’ efforts and plans to commercialize the
Licensed Technology and to manufacture, offer to sell, or sell
Licensed Products.
5.5
Use of the
University’s Name and Trademarks or the Names of University
Faculty, Staff, or Students. No provision of this Agreement grants
the Licensee or sublicensee any right or license to use the name,
logo, or any marks owned by or associated with the University or
the names, or identities of any member of the faculty, staff, or
student body of the University. The Licensee shall not use and
shall not permit a sublicensee to use any such logos, marks, names,
or identities without the University’s prior written
approval.
5.6
Governmental
Markings.
5.6.1
The Licensee shall
mark all Licensed Products, where feasible, with patent notice
appropriate under Title 35, United States Code.
5.6.2
The Licensee is
responsible for obtaining all necessary governmental approvals for
the development, production, distribution, sale, and use of any
Licensed Product, at the Licensee’s expense, including,
without limitation, any safety studies. The Licensee is responsible
for including with the Licensed Product any warning labels,
packaging and instructions as to the use and the quality control
for any Licensed Product.
5.6.3
The Licensee agrees
to register this Agreement with any foreign governmental agency
that requires such registration, and the Licensee shall pay all
costs and legal fees in connection with such registration. The
Licensee shall comply with all foreign laws affecting this
Agreement or the sale of Licensed Products.
6.
Payments,
Reimbursements, Reports, and Records.
6.1
Payments. The
Licensee shall pay all amounts due under this Agreement by check
(payable to the “Regents of the University of
Minnesota” and sent to the address specified in section
12.13), wire transfer, or any other mutually agreed-upon method of
payment.
6.2
Interest.
All amounts due under this Agreement shall bear interest at 12% per
annum on the entire unpaid balance computed from the due date until
the amount is paid.
6.3
Reimbursement of
Patent-Related Expenses. The Licensee shall pay invoices for
Patent-Related Expenses under this Agreement within thirty (30)
days of its receipt of the University’s invoice. With respect
to each invoice, the University shall use reasonable efforts to
specify the date on which the Patent-Related Expense was incurred
and the purpose of the expense (including, as applicable, a summary
of patent attorney services giving rise to the expense); provided,
however, the University is not required to disclose to the Licensee
any information that is protected by the University’s
attorney-client privilege. Patent-Related Expenses incurred as of
the Effective Date are set forth in section 6 of the EPLA. The
University reserves the right to require that Licensee provide and
maintain a reasonable advance deposit with the University or some
other form of security to ensure payment of Patent-Related
Expenses.
A-6
6.4
Royalty
Payments/Sales Reports. Within sixty (60) days after the last day
of the second and fourth calendar quarters during the Term and the
Post-termination Period, the Licensee shall deliver to the
University a written sales report in the form acceptable to the
University, recounting the number and Net Sales Amount (expressed
in U. S. dollars) of all sales, leases, or other dispositions of
Licensed Products, whether made by the Licensee or a sublicensee,
during such semi-annual period. The Licensee shall deliver such
written report to the University even if the Licensee is not
required hereunder to pay to the University a payment for sales,
leases, or other dispositions of Licensed Products during the
semi-annual period. The Licensee shall deliver along with such
sales reports its payment for royalties owed on all Net Sales of
Licensed Products by the Licensee and the sublicensees during such
semi-annual period.
6.5
Records Retention
and Audit Rights.
6.5.1
Throughout the Term
and the Post-termination Period and for five (5) years thereafter,
the Licensee, at its expense, shall keep and maintain and shall
cause each sublicensee and each non-affiliated Third Party that
manufactures, sells, leases, or otherwise disposes of Licensed
Products on behalf of the Licensee to keep and maintain complete
and accurate records of all sales, leases, and other dispositions
of Licensed Products during the Term and the Post-termination
Period and all other records related to this
Agreement.
6.5.2
In connection with
an audit, the Licensee, upon written request, shall deliver to the
University and its representatives true, correct and complete
copies of all documents and materials (including electronic
records) reasonably relevant to the Licensee’s and
sublicensees’ performance of this Agreement, including,
without limitation, all sublicenses granted.
6.5.3
To determine the
Licensee’s compliance with the terms of this Agreement, the
University, at its expense (except as set forth in this
subsection), may inspect and audit the Licensee’s records
referred to in subsection 6.5.1 at the Licensee’s address as
set forth in this Agreement or such other location(s) as the
parties mutually agree during the Licensee’s normal business
hours. The Licensee shall cooperate in the audit, including
providing at no cost, commodious space in the Licensee’s
place of business for the auditor. The Licensee shall reimburse the
University for all its out-of-pocket expenses to inspect and audit
such records if the University, in accordance with the results of
such inspection and audit, determines that the Licensee has
underpaid amounts owed to the University by at least three percent
(3%) or twenty-five thousand dollars ($25,000), whichever is
smaller, in a reporting period. The Licensee shall cause each
sublicensee and each non-affiliated Third Party that manufactures,
sells, leases, or otherwise disposes of Licensed Products on behalf
of the Licensee to grant the University a right to inspect and
audit the sublicensee’s or Third Party’s records
substantially similar to the rights granted the University in this
subsection. In connection with, and before the commencement of, an
audit, if the Licensee requests in writing to the University, then
prior to conducting such audit, the Licensee, the University and
the auditor must enter into an agreement prohibiting the auditor
and the University from disclosing the Licensee’s nonpublic,
proprietary information to any Third Party without the
Licensee’s prior written consent; provided, however, that
consistent with generally accepted auditing standards and the
auditor’s professional judgment, the auditor may disclose
such information to the University and its agents, counsel, or
consultants. The Licensee acknowledges that such an agreement is
adequate to protect its legitimate interests, and the parties agree
that there shall be no additional nondisclosure agreement demanded
as a condition to the commencement of an audit and the
University’s exercising its rights under this
subsection.
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6.6
Currency and
Checks. All computations and payments made under this Agreement
shall be in United States dollars. To determine the dollar value of
transactions conducted in non-United States dollar currencies, the
parties shall use the exchange rate for the currency into dollars
as reported in the Wall Street
Journal as the New York foreign exchange mid-range rate on
the last business day of the month in which the transaction
occurred.
7.
Infringement.
7.1
If a party learns
of substantial, credible evidence that a Third Party is making,
using, or selling a product in the Field of Use in the Territory
that infringes a Licensed Patent, such party shall promptly notify
the other party in writing of the possible infringement and in such
notice describe in detail the information suggesting infringement
of the Licensed Patent. Prior to commencing any action to enforce a
Licensed Patent, the parties shall enter into good faith
negotiations on the desirability of bringing suit, the parties to
the action, the selection of counsel, and such other matters as the
parties may agree to discuss. No provision of this Agreement
limits, conditions, or otherwise affects a party’s statutory
and common-law rights to commence an action to enforce a Licensed
Patent. In any such action, the parties agree to cooperate fully
with each other and will use reasonable efforts to permit access to
relevant personnel, records, papers, information, samples and
specimens during regular business hours. Any amounts recovered
(less amounts actually paid for reasonable attorney’s fees
and legal expenses) by Licensee in any such action or settlement
that constitute compensation for lost profits or sales will be
considered subject to the royalty rate in subsection 11.4.1 of the
EPLA. All other amounts recovered (less amounts actually paid for
reasonable attorney’s fees and legal expenses) by Licensee in
such action or settlement shall be considered subject to the rate
for Sublicense Revenues in subsection 11.5.2 of the
EPLA.
7.2.
If any suit, action
or proceeding is brought or commenced against the Licensee alleging
the infringement of a patent or other intellectual property right
owned by a Third Party by reason of the manufacture, use or sale of
Licensed Products, the Licensee shall give the University prompt
notice thereof. If the validity of a Licensed Patent is questioned
in such suit, action or proceeding, the Licensee shall have no
right to make any settlement or compromise which affects the scope,
validity, enforceability or otherwise the Licensed Patent without
the University’s prior written approval.
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8.
Termination.
8.1 University
may terminate this Agreement if Licensee
(A) is
delinquent on any report or payment;
(B) is
not diligently developing and commercializing Licensed
Product;
(C) misses
a milestone under Section 11.9 of the EPLA;
(D) is
in breach of any provision of this Agreement;
(E) provides
any false report; or
(F) fails
to enter into any of the following agreements by the dates
indicated below; or having so entered in to the following
agreements, defaults on any of the terms contained therein, or
terminates the agreement(s).
➢
Sponsored research
agreement within 90 days of the Effective Date of this Agreement
with the University to carry out further research on (1) the TriKE
platform including the cytokine linker and the best target antigens
on cancer targets and (2) building on higher production systems
that generate higher concentrations of TriKEs for expanded use
beyond the initial bacterial production used for phase I
testing.
Termination under
this Section 8.1 will take effect 30 days after written notice by
University unless Licensee remedies the default in that 30-day
period.
8.2
Licensee may
terminate this Agreement
(A)
any time prior to the dosing of the first patient in a Phase I
clinical trial upon payment of $200,000 to the University;
or
(B) any
time after the dosing of the first patient in a Phase I clinical
trial upon payment of $75,000 to the University.
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8.2
Surviving Provisions. Surviving any termination or expiration
are:
(A) Licensee's
obligation to pay royalties accrued or accruable;
(B) any claim of
Licensee or University, accrued or to accrue, because of any breach
or default by the other party; and
(C) the provisions of
Articles 8, 9, and 10 and any other provision that by its nature is
intended to survive.
9.
Indemnification,
and Insurance.
Licensee shall
indemnify, hold harmless, and defend all University Indemnitees
against any claim of any kind arising out of or related to the
exercise of any rights granted Licensee under this Agreement or the
breach of this Agreement by Licensee.
9.4
The
Licensee’s Insurance.
9.4.1
Throughout the
Term, or during such other period as the parties agree in writing,
the Licensee shall maintain, and shall cause each sublicensee to
maintain, in full force and effect comprehensive general liability
(“CGL”) insurance, with single claim limits acceptable
to the University. Such insurance policy shall include coverage for
claims that may be asserted by the University against the Licensee
under section 9.2 and for claims by a Third Party against the
Licensee or the University arising out of the purchase or use of a
Licensed Product. Such insurance policy must (i) name the
University as an additional insured if the University so requests
in writing and (ii) require the insurer to deliver written notice
to the University at the address set forth in section 12.13, at
least thirty (30) days before the termination of the policy. Upon
receipt of the University’s written request, the Licensee
shall deliver to the University a copy of the certificate of
insurance for such policy.
9.4.2
The provisions of
subsection 9.4.1 do not apply if the University agrees in writing
to accept the Licensee’s or a sublicensee’s, as the
case may be, self-insurance plan as adequate
insurance.
9.5
Sublicensees -
Release. The Licensee shall cause each sublicensee to grant the
University a release from liabilities substantially similar to the
release granted in favor of the University in section
9.1.
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10.
Disclaimer
of Warranties.
UNIVERSITY PROVIDES
LICENSEE THE RIGHTS GRANTED IN THIS AGREEMENT AS IS AND WITH ALL
FAULTS. UNIVERSITY MAKES NO REPRESENTATIONS AND EXTENDS NO
WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED. AMONG OTHER
THINGS, THE UNIVERSITY EXPRESSLY DISCLAIMS ANY WARRANTIES
CONCERNING AND MAKES NO REPRESENTATIONS:
(i)
that the Licensed
Patent Applications will be allowed or granted or that a patent
will issue from any Licensed Patent Application;
(ii)
concerning the
validity, enforceability, interpretation of claims or scope of any
Licensed Patent; or
(iii)
that the exercise
of the rights or licenses granted to the Licensee under this
Agreement will not infringe a Third Party’s patent or violate
its intellectual property rights;
(iv)
that the
exploitation of Licensed Patent or Technology will be
successful
10.3
Sublicensees -
Warranties. The Licensee shall cause each sublicensee to give the
University warranties and disclaimers and exclusions of warranties
substantially similar to the warranty and disclaimers and
exclusions of warranties in favor of the University in section 10.1
and subsections 10.2.1 and 10.2.2.
11.
Damages.
11.1
No
Indirect Liability. University is not liable for any special,
consequential, lost profit, expectation, punitive or other indirect
damages in connection with any claim arising out of or related to
this Agreement,
12.
General
Terms
12.1
Access to
University Information.
12.1.1
Data Practices Act.
The parties acknowledge that the University is subject to the terms
and provisions of the Minnesota Government Data Practices Act,
Minnesota Statutes §13.01 et
seq. (the “Act”), and that the Act requires,
with certain exceptions, the University to permit the public to
inspect and copy any information that the University collects,
creates, receives, maintains, or disseminates.
12.1.2
Confidentiality. To the extent permitted by law, including as
provided in the Act, the University shall hold in confidence and
disclose only to University employees, agents and contractors who
need to know the reports described in sections 5.4 and 6.4 and the
records inspected in accordance with section 6.5 of the Terms and
Conditions. No provision of this Agreement is to be construed to
further prohibit, limit, or condition the University’s right
to use and disclose any information in connection with enforcing
this Agreement, in court or elsewhere.
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12.2 Amendment
and Waiver. The
Agreement may be amended from time to time only by a written
instrument signed by the parties. No term or provision of this
Agreement may be waived and no breach excused unless such waiver or
consent is in writing and signed by the party claimed to have
waived or consented. No waiver of a breach is to be deemed a waiver
of a different or subsequent breach.
12.3 Applicable
Law and Forum Selection. The internal laws of the state of
Minnesota, without giving effect to its conflict of laws
principles, govern the validity, construction, and enforceability
of this Agreement. A suit, claim, or other action to enforce the
terms of this Agreement may be brought only in the state courts of
Hennepin County, Minnesota. The Licensee hereby submits to the
jurisdiction of that court and waives any objections it may have to
that court asserting jurisdiction over the Licensee or its assets
and property.
12.4 Assignment
and Sublicense. Except as permitted under subsection 3.1.2 and
section 12.5 of the Terms and Conditions, the Licensee shall not
assign or sublicense its interest or delegate its duties under this
Agreement. Any assignment, sublicense, or delegation attempted to
be made in violation of this section is void. Absent the consent of
all the parties, an assignment or delegation will not release the
assigning or delegating party from its obligations. The Agreement
inures to the benefit of the Licensee and the University and their
respective permitted sublicensees and trustees.
12.5 Change
of Control. Licensee
may assign this Agreement as part of a Change of Control upon prior
and complete performance of the following conditions:
(A) Licensee
must give University 30 days prior written notice of the
assignment, including the new assignee’s contact
information;
(B) the
new assignee must agree in writing to University to be bound by
this Agreement; and
(C)
University must
have received the full Change of Control Fee.
12.6 Collection
Costs and Attorneys’ Fees. If a party fails to perform an
obligation or otherwise breaches one or more of the terms of this
Agreement, the other party may recover from the non-performing
breaching party all its reasonable costs (including actual
attorneys’ and investigative fees) to enforce the terms of
this Agreement.
12.7 Consent
and Approvals. Except as otherwise expressly provided, in order to
be effective, all consents or approvals required under this
Agreement must be in writing.
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12.8 Construction.
The headings preceding and labeling the sections of this Agreement
are for the purpose of identification only and are not to be
employed or used for the purpose of construction or interpretation
of any portion of the EPLA. As used herein and where necessary, the
singular includes the plural and vice versa, and masculine,
feminine, and neuter expressions are interchangeable.
12.9 Enforceability.
If a court of competent jurisdiction adjudges a provision of this
Agreement to be unenforceable, invalid, or void, such determination
is not to be construed as impairing the enforceability of any of
the remaining provisions hereof and such provisions will remain in
full force and effect.
12.10
Entire Agreement. The parties intend this Agreement (including all
attachments, exhibits, and amendments hereto) to be the final and
binding expression of their contract and agreement and the complete
and exclusive statement of the terms thereof. The Agreement
cancels, supersedes, and revokes all prior negotiations,
representations and agreements among the parties, whether oral or
written, relating to the subject matter of this
Agreement.
12.11
Language and Currency. Unless otherwise expressly provided in this
Agreement and in order to be effective, all notices, reports, and
other documents and instruments that a party elects or is required
to deliver to the other party must be in English, and all notices,
reports, and other documents and instruments detailing revenues and
earned under this Agreement or expenses chargeable to a party must
be United States dollar denominated.
12.12
No Third-Party Beneficiaries. No provision of this Agreement,
express or implied, is intended to confer upon any person other
than the parties to this Agreement any rights, remedies,
obligations, or liabilities hereunder. No sublicensee may enforce
or seek damages under this Agreement.
12.13
Notices. In order to be effective, all notices, requests, and other
communications that a party is required or elects to deliver must
be in writing and must be delivered personally, or by facsimile or
electronic mail (provided such delivery is confirmed), or by a
recognized overnight courier service or by United States mail,
first-class, certified or registered, postage prepaid, return
receipt requested, to the other party at its address set forth
below or to such other address as such party may designate by
notice given under this section:
If to
the
University:
University of Minnesota
Office
for Technology Commercialization
200 Oak
Street, SE
Suite
280
Minneapolis, MN
55455
Phone:
612.624.0550
Fax:
612.624.6554
E-mail:
otcagree@umn.edu
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For notices
sent
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University of
Minnesota
|
|
under section
8,
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Office of the
General Counsel
|
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with a copy
to:
|
Attn: Transactional
Law Services
|
|
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360 McNamara Alumni
Center
|
|
|
200 Oak Street
S.E.
|
|
|
Minneapolis, MN
55455-2006
|
|
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Facsimile No.:
612.626.9624
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|
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E-mail:
contracts@mail.ogc.umn.edu
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If to the
Licensee:
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As indicated in
section 12 of the EPLA
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12.14 Relationship
of Parties. In entering into, and performing their duties under
this Agreement, the parties are acting as independent contractors
and independent employers. No provision of this Agreement creates
or is to be construed as creating a partnership, joint venture, or
agency relationship between the parties. No party has the authority
to act for or bind the other party in any respect.
12.15 Security
Interest. In no event may the Licensee grant, or permit any person
to assert or perfect, a security interest in the Licensee’s
rights under this Agreement.
12.16 Survival.
Immediately upon the termination or expiration of this Agreement,
except for certain rights granted for the Post-termination Period,
all the Licensee’s rights under this Agreement terminate;
provided, however, the Licensee’s obligations that have
accrued before the effective date of termination or expiration
(e.g., the obligation to
report and make payments on sales, leases, or dispositions of
Licensed Products and to reimburse the University for costs) and
the obligations specified in section 6.1 survive. The obligations
and rights set forth in sections 6.4 and 8.3 and sections 9, 10,
and 11 also survive the termination or expiration of this
Agreement.
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