Document:

Blueprint

 

 

[***] = Confidential Information has been
omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

AMENDED AND RESTATED LICENSE AGREEMENT

 

THIS
AMENDED AND RESTATED LICENSE AGREEMENT (this “Agreement”), effective as
of September 24, 2014 (the “Effective Date”), is
entered into between Tactic Pharma, LLC, a limited liability
company (“TACTIC”), having offices
at 1062 Princeton Avenue, Highland Park, IL 60035 and XOMA (US)
LLC, a Delaware limited liability company (“XOMA”), having offices at
2910 Seventh Street, Berkeley, California 94710. Each of XOMA and
TACTIC are sometimes referred to herein separately as a
“Party”
and together as “Parties.”

 

WHEREAS
TACTIC was formed upon the dissolution of Attenuon, LLC, San Diego,
California, 92121 (“ATTENUON”), such that TACTIC can be
considered a successor of ATTENUON;

 

WHEREAS
TACTIC is the successor and rightful owner of certain IP rights
developed by ATTENUON, including, but not limited to,
ATN-658;

 

WHEREAS
ATTENUON and XOMA had entered into a certain HUMAN
ENGINEERINGTM LICENSE AGREEMENT, effective September 29, 2006,
(the “Prior Agreement”) in which, among other things,
Attenuon, LLC obtained a license to certain HUMAN ENGINEERING
PATENT RIGHTS as described in the Prior Agreement for the purposes
of developing and commercializing human engineered
ATN-658;

 

WHEREAS
for the good and valuable consideration set forth in this
agreement, the Parties agree that all rights, claims, and
obligations under the Prior Agreement between Attenuon, LLC, its
successors, and XOMA are now null and void unless expressly
restated herein. Accordingly, the Parties agree that there are no
outstanding payments, liabilities, or other obligations owed by
TACTIC to XOMA under the Prior Agreement.

 

For
good and valuable consideration, the receipt and sufficiency of
which are hereby acknowledged, the Parties agree as
follows:

 

ARTICLE
1

 

 

 

DEFINITIONS

 

For
purposes of this Agreement, the terms defined in this Article 1
shall have the respective meanings set forth below:

 

1.1 “Affiliate” shall mean,
with respect to any Person, any other Person which, presently or in
the future, directly or indirectly controls, is controlled by, or
is under common control with, such Person.

 

1.2 “Antibody” shall mean any
immunoglobulin molecule (such as IgG), whether in monospecific or
any other form, and shall include, without limitation, any
immunoglobulin fragment (such as Fv, Fab, F(ab') or
F(ab')2),
any fusion protein of an immunoglobulin or immunoglobulin fragment
and any single chain antibody (such as scFv), as well as any
derivative of any of the foregoing.

 

 

 

 

[***] = Confidential Information has been
omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

1.3 “TACTIC Antibody” shall
mean the non-human Antibody directed to the TACTIC Target, referred
to by TACTIC as “ATN-658”

 

1.4  “TACTIC
Patent Rights” shall have the meaning set forth in
Section 1.6.

 

1.5 “TACTIC Program
Inventions” shall have the meaning set forth in
Section 1.6.

 

1.6  “TACTIC
Program Inventions and Patent Rights” shall mean any
and all (a) Program Inventions, whether or not patentable, that (i)
comprise or embody (A) [***], (B) [***], (C) [***], (D) [***], (E)
[***] and (F) any uses of any and all of the foregoing, or (ii) do
not meet the definition of [***] by virtue of the preceding clause
(i) or the definition of [***] by virtue of clause (i) thereof and
were [***] (collectively, the “TACTIC Program
Inventions”); and (b) Patent Rights arising out of the
conduct of activities under the Prior Agreement that claim or cover
such TACTIC Program Inventions (the “TACTIC Patent Rights”).
Notwithstanding the foregoing, TACTIC Program Inventions and Patent
Rights do not include any [***] and Patent Rights; provided that the foregoing shall not
apply to [***] (I) [***] (II) [***] (III) [***] (IV) [***] (V)
[***] and (VI) any uses of any and all of the foregoing, each of
which shall be included in the [***] and [***].

 

1.7 “TACTIC Target” shall mean
the target antigen known as urokinase-type plasminogen activator
receptor (uPAR).

 

1.8 “Combination Product”
shall have the meaning set forth in Section 1.22.

 

1.9 “Composition of Matter”
shall mean any composition of matter or article of
manufacture.

 

1.10 “Confidential
Information” shall mean any proprietary or
confidential information or material disclosed by a Party to the
other Party pursuant to the Prior Agreement or this Agreement which
is (a) disclosed in tangible form and is designated thereon as
“Confidential” at the time it is delivered to the
receiving Party, or (b) disclosed orally and identified as
confidential or proprietary when disclosed and such disclosure of
confidential information is confirmed in writing within thirty (30)
days by the disclosing Party. Notwithstanding the foregoing,
Confidential Information shall not include information which the
receiving Party can establish by written documentation (i) to have
been publicly known prior to disclosure of such information by the
disclosing Party to the receiving Party, (ii) to have become
publicly known, without fault on the part of the receiving Party,
subsequent to disclosure of such information by the disclosing
Party to the receiving Party, (iii) to have been received by the
receiving Party at any time from a source, other than the
disclosing Party, rightfully having possession of and the right to
disclose such information, other than under an obligation
of

 

 

 

 

[***] = Confidential Information has been
omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

confidentiality,
(iv) to have been otherwise rightfully known by the receiving Party
prior to disclosure of such information by the disclosing Party to
the receiving Party, other than under an obligation of
confidentiality, or (v) to have been independently developed by
employees or agents of the receiving Party without access to or use
of such information disclosed by the disclosing Party to the
receiving Party without violating any obligation of confidentiality
or non-use.

 

1.11 “Control,”
“Controls” and
“Controlled” shall mean,
with respect to a particular item of information or Intellectual
Property Right, that the applicable Party or any of its Affiliates
owns (whether solely or jointly with the other Party or any Third
Party), or has a license to, such item or right and has the ability
to grant to the other Party access to, and a license or sublicense
(as applicable) under, such item or right as provided for herein
without violating the terms of any agreement with any Third
Party.

 

1.12  “CPR”
shall have the meaning set forth in Section 9.2.

 

1.13 “Dispute”
shall have the meaning set forth in Section 9.1.

 

1.14 “Human
EngineerTM,” “Human EngineeredTM”
and “Human
EngineeringTM” shall mean, for purposes of this
Agreement, with respect to a particular Antibody, resulting from,
or otherwise practicing, the methods of the Human
EngineeringTM Patent Rights or any other proprietary protein
engineering methods used by XOMA for modifying non-human Antibodies
with the intended purpose of making them suitable for medical
purposes in humans.

 

1.15 “Human
EngineeredTM TACTIC Antibodies” shall mean the
Human EngineeredTM versions of the TACTIC Antibodies provided
by XOMA under the Prior Agreement.

 

1.16 “Human
EngineeringTM Patent Rights” shall mean the
Patent Rights listed on Schedule 1.16 hereto and all
patents issuing on any of the applications so listed, including
extensions, reissues and re-examinations.

 

1.17 “Indemnitee”
shall have the meaning set forth in Section 8.2.

 

1.18 “Indemnitor”
shall have the meaning set forth in Section 8.2.

 

1.19 “Intellectual
Property Rights” shall mean Patent Rights, copyrights,
trademarks, service marks, know-how, trade secrets, and
applications and registrations for the foregoing, in any country,
supranational organization or territory of the world.

 

1.20  "Joint
Program Inventions" shall mean
any and all Program Inventions, whether or not patentable, that are
invented jointly by employees, agents, consultants or contractors
of both [***], but [***].

 

1.21 "Major
Market Country" shall mean any of the United States of
America, Japan or any of the top five (5) countries (measured by
pharmaceutical sales for the most recently com­ pleted
calendar year for which such information is available at the time
of determination) of the European Union.

 

 

 

 

[***] = Confidential Information has been
omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

1.22  “Milestone
Payment” shall have the meaning set forth in Section
3.1.

 

1.23 “Net
Sales” shall mean the gross amount invoiced by TACTIC,
its Affiliates, assignees or sublicensees for sales of Products to
Third Parties, less
the following items, as allocable to such Products:

 

(a) trade discounts,
rebates or allowances actually allowed and taken directly with
respect to such sales;

 

(b) credits or
allowances additionally granted upon returns, rejections, recalls
or retroactive price reductions;

 

(c) freight, shipping
and insurance charges;

 

(d)
[***];

 

(e) taxes, duties or
other governmental tariffs (other than income taxes);
and

 

(f) government mandated
rebates.

 

In the
event that a Product is sold as part of a Combination Product (as
defined below) in any country, the Net Sales of the Product as part
of a Combination Product in that country for the purposes of
determining royalty payments shall be determined by multiplying the
Net Sales of the Combination Product in that country by the
fraction (A/A+B) where A is the average sale price in the relevant
quarterly period of the Product in that country when sold
separately in finished form and B is the average sale price in the
relevant quarterly period of the Other Element (as defined below)
in that country sold separately in finished form. In the event that
the average sale price of the Product in that country can be
determined but the average sale price of the Other Element in that
country cannot be determined, Net Sales of the Product in that
country for the purposes of determining royalty payments shall be
calculated by multiplying the Net Sales of the Combination Product
in that country by the fraction (C/D) where C is the selling
Party's average sales price in the relevant quarterly period of the
Product and D is the average selling price in the relevant
quarterly period of the Combination Product in that country. If the
average sale price of the Other Element in that quarterly period
can be determined but the average price of the Product in that
country cannot be determined, Net Sales of the Combination Product
in that country for the purposes of determining royalty payments
shall be calculated by multiplying the Net Sales of the Combination
Product in that country by the following formula: one (1) minus E/D where E is the average
selling price in the relevant quarterly period of the Other Element
in that country and D is the average selling price of the
Combination Product in that country in the relevant quarterly
period. If the average sale price of both the Product and the Other
Element cannot be deter­ mined, the Net Sales of the Product
shall be reasonably agreed upon by the Parties. As used herein, the
term "Combination
Product" shall mean a product which contains or comprises a
Product as an active component and at least one other active
compound (an "Other
Element").

 

 

Provision
of Products free of charge for clinical trials, for promotional or
sampling purposes or as donations (for example to non-profit
institutions or government agencies for a non-commercial purpose)
at levels not in excess of industry norms, shall not be considered
in determining Net Sales.

 

 

 

[***] = Confidential Information has been
omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

1.24 “Patent
Prosecution” shall mean, with respect to particular
Patent Rights, (a) preparing, filing and prosecuting patent
applications (including, but not limited to, provisional,
non-provisional, reissue, reexamination, continuing, continuation,
continuation-in-part, divisional, and substitute applications and
any foreign counterparts thereof) of such Patent Rights; (b)
maintaining such Patent Rights; and (c) managing or conducting any
interference or opposition or similar proceedings relating to the
foregoing.

 

1.25 “Patent
Rights” shall mean any of the following, whether
existing now or in the future anywhere in the world:
(a) patents and patent applications; (b) continuations,
continuations-in-part, divisionals and substitute applications with
respect to any such patent application; (c) any patents issued
based on or claiming priority to any such patent applications;
(d) any reissue, reexamination, renewal or extension
(including any supplemental patent certificate) of any such
patents; and (e) any confirmation patent or registration patent or
patent of addition based on any such patents.

 

1.26 “Person”
shall mean an individual, corporation, partnership, limited
liability company, trust, business trust, association, joint stock
company, joint venture, pool, syndicate, sole proprietorship,
unincorporated organization, governmental authority or any other
form of entity or organization not specifically listed
herein.

 

1.27 “Product”
shall mean any Composition of Matter
that comprises or contains the Human EngineeredTM
Tactic Antibodies or any derivatives,
conjugates and/or fragments thereof.

 

1.28 "Program
Invention" shall mean any invention (whether or not
patentable), discovery, Composition of Matter, improvement,
enhancement, technology, data or information made or conceived in
connection with the conduct of activities pursuant to the Prior
Agreement.

 

1.29 “PTO”
shall have the meaning set forth in Section 5.4(c).

 

1.30 “Term”
shall have the meaning set forth in Section 7.1.

 

1.31 “Third
Party” shall mean any Person other than XOMA or TACTIC
or their Affiliates.

 

1.32 “Title
XI” shall have the meaning set forth in Section
11.2.

 

1.33  “Valid
Claim” shall mean (a) a claim of an issued and
unexpired patent which has not been held permanently revoked,
unenforceable or invalid by a decision of a court or other
governmental agency of competent jurisdiction, unappealable or
unappealed within the time allowed for appeal and that is not
admitted to be invalid or unenforceable through reissue, disclaimer
or otherwise, or (b) a claim (including amendments) of a pending
patent application that has neither (i) been abandoned or finally
rejected without the possibility of appeal or refiling nor (ii)
been pending for more than [***], provided that any claim excluded from
this definition in reliance on this clause (b)(ii) that
subsequently issues shall constitute a Valid Claim so long as it
meets the requirements of clause (a) above.

 

 

 

[***] = Confidential Information has been
omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

1.34 "XOMA
Deliverables" shall mean the XOMA materials and information
delivered to ATTENUON under the Prior Agreement.

 

1.35 “XOMA
Patent Rights” shall have the meaning set forth in
Section 1.37.

 

1.36 “XOMA
Program Inventions” shall have the meaning set forth
in Section 1.37.

 

1.37 “XOMA
Program Inventions and Patent Rights” shall mean any
and all (a) Program Inventions, whether or not patentable, that (i)
comprise or embody (A) [***] (B) methods that are generally
applicable to the [***] or (ii) do not [***] and were invented
solely by employees, agents, consultants or contractors of [***]
(collectively, the “XOMA Program
Inventions”); and (b) all Patent Rights arising out of
the conduct of activities under the Prior Agreement that claim or
cover such XOMA Program Inventions (the “XOMA Patent
Rights”).

 

ARTICLE
2

 

 

 

INTELLECTUAL PROPERTY RIGHTS

 

2.1 License Grants to TACTIC. XOMA
hereby grants to TACTIC:

 

(a) a worldwide,
non-exclusive license, with the right to sublicense in its sole
discretion, under any and all Intellectual Property Rights
Controlled by XOMA at any time during the Term covering, claiming
or relating to Program Inventions, and/or XOMA’s Human
EngineeringTM technology utilized in XOMA's performance of work under the
Prior Agreement including, without limitation, the Human
EngineeringTM Patent
Rights), to make, have made, use, offer for sale, sell and import
Human EngineeredTM TACTIC Antibodies and any
Product.

 

2.2 Ownership of Intellectual
Property.

 

2.2.1 Inventorship
for Program Inventions shall be determined in accordance with U.S.
patent laws.

 

2.2.2 TACTIC
reserves and shall retain all right, title and interest in and to
the TACTIC Antibody and all Intellectual Property Rights
therein.

 

2.2.3 Subject
to the rights and licenses granted under this Agreement, ownership
of all Program Inventions, irrespective of inventorship, shall be
as follows: (a) TACTIC shall own TACTIC Program Inventions and
Patent Rights; (b) XOMA shall own all XOMA Program Inventions and
Patent Rights; and (c) TACTIC and
XOMA shall jointly own, in equal undivided shares, any Joint
Program Inventions.

 

 

 

[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

2.2.4 XOMA
hereby assigns, and agrees to assign, to TACTIC all of XOMA’s
right, title and interest in and to any and all TACTIC Program
Inventions and Patent Rights, including, without limitation, the
right to sue for past, present and future infringement. XOMA
agrees, without further consideration, to execute all documents,
certificates and other instruments, and to do all acts reasonably
necessary to vest and confirm in TACTIC, its successors and
assigns, the legal title to all such Program Inventions and Patent
Rights; provided that, if
such requests require more than de
minimis out-of-pocket expenditures by XOMA, TACTIC will
reimburse XOMA for such expenditures, to the extent previously
approved by TACTIC in writing (which approval shall not be
unreasonably withheld or delayed).

 

2.2.5 TACTIC
hereby assigns, and agrees to assign, to XOMA all of TACTIC’s
right, title and interest in and to any and all XOMA Program
Inventions and Patent Rights, including, without limitation, the
right to sue for past, present and future infringement. TACTIC
agrees, without further consideration, to execute all documents,
certificates and other instruments, and to do all acts reasonably
necessary to vest and confirm in XOMA, its successors and assigns,
the legal title to all such Program Inventions and Patent Rights;
provided that, if such
requests require more than de
minimis out-of-pocket expenditures by TACTIC, XOMA will
reimburse TACTIC for such expenditures, to the extent previously
approved by XOMA in writing (which approval shall not be
unreasonably withheld or delayed).

 

2.3 No Implied Rights. Only the
rights and licenses granted pursuant to the express terms of this
Agreement shall be of any legal force. Without limiting the
foregoing and subject to the license granted by XOMA in Section
2.1, neither the grants provided in Section 2.1 nor the assignment
from XOMA to TACTIC provided in Section 2.2.4 provide TACTIC with
any right to practice the methods of the Human EngineeringTM
technology (including, without limitation, the Human
EngineeringTM Patent Rights)
or, subject to the grants made in Section 2.1, to receive from XOMA
or use information received from XOMA related to its Human
EngineeringTM technology, and in no event shall XOMA be
required to disclose such methods or information.

 

2.4 Sublicenses. Any sublicense
permitted hereunder shall be set forth in a written agreement
containing provisions relating to ownership of intellectual
property that are substantially consistent with, and with respect
to audits and confidentiality that are substantially consistent
with, and at least as stringent as, those contained herein and
shall be subject and subordinate to the terms and conditions of
this Agreement.

 

ARTICLE
3

 

 

 

FINANCIAL TERMS

 

3.1 Milestone Payments. In full
consideration of the rights and licenses granted to TACTIC herein,
TACTIC shall pay to XOMA the applicable payments below (each, a
“Milestone
Payment”)

 

	

Event

 

	

Payment

 

	

1.
[***]

 

	

[***]

 

 

 

 

[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

	

2.
[***]

 

	

[***]

 

	

3.
[***]

 

	

[***]

 

	

4.
[***]

 

	

[***]

 

	

5.
[***]

 

	

[***]

 

	

6.
[***]

 

	

[***]

 

Each
Milestone Payment shall be due [***] days from the achievement of
the corresponding milestone event. Each Milestone Payment [***],
and [***] (a) [***] or (b) [***].

 

3.2 Third Party Payments. TACTIC
will be responsible for all financial obligations due Third
Parties.

 

3.3 Payments; Currency. All
payments due under this Article 3 shall be paid in United States
dollars in immediately available funds to an account designated by
XOMA.

 

3.4 Payment Reports and
Timing.

 

3.4.1 TACTIC
shall make a written report to XOMA within thirty (30) days of the
achievement of each of the milestones set forth in Section 3.1
with respect to Product

 

3.5 Payment Records and
Audits.

 

3.5.1 TACTIC
shall, and shall contractually require all Third Parties selling
Products on its behalf to, keep complete and accurate books of
account for, and records of Net Sales of, Product in sufficient
detail to enable the milestone payments payable under this
Agreement to be determined

 

3.5.2 Upon
the written request of XOMA, TACTIC shall permit an independent
auditor appointed by XOMA and reasonably acceptable to TACTIC to
have access during normal business hours to such of the records of
TACTIC and its Affiliates as may be reasonably necessary to verify
the accuracy of the Net Sales under this Agreement. The auditor
shall only disclose to XOMA whether the Net Sales reported are
correct or incorrect and the amount of any discrepancy. No other
information shall be provided to XOMA without the prior consent of
TACTIC unless disclosure is required by law, regulation or judicial
order. If XOMA determines that disclosure is required by law,
regulation or judicial order, it shall give TACTIC reasonable prior
notice thereof in order for TACTIC to seek a protective order
against or limiting such disclosure. TACTIC is entitled to require
the auditor to execute a reasonable confidentiality agreement prior
to commencing any such audit. Any agreement between TACTIC and/or
any of its Affiliates, on the one hand, and one or more Third
Parties, on the other hand, pursuant to which such Third Party may
market and/or sell Product shall contain provisions for access and
inspection of records substantially similar to the
foregoing.

 

 

 

[***] = Confidential Information has been
omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

3.5.3 Audits
conducted under this Section 3.5 shall be at the expense of XOMA
unless an unpaid amount for the full
period covered by the audit is identified, in which case all
reasonable out-of-pocket costs incurred by the auditor to perform
the audit will be paid promptly by TACTIC. Any unpaid amounts
discovered by such inspections or otherwise will be paid promptly
by TACTIC, with interest on such amounts from the date(s) such
amount(s) were due, at a rate equal to the lesser of the prime rate
reported by the Bank of America plus [***] per annum, or the
highest interest rate permitted under applicable New York
law.

 

ARTICLE
4

 

 

 

CONFIDENTIALITY

 

4.1 Confidential Information.
Except as expressly provided herein, the Parties agree that, for
the Term and for [***] thereafter, each of them shall keep
completely confidential and shall not publish or otherwise disclose
and shall not use for any purpose except for the purposes
contemplated by this Agreement any Confidential Information
furnished to it by the other Party. Each Party also agrees to cause
its Affiliates with access to any Confidential Information to
comply with all terms of this Agreement relating to such
Confidential Information and the treatment thereof, and each Party
shall remain primarily liable for any breach of any such provision
by any of its Affiliates.

 

4.2 Permitted Use and Disclosures.
The receiving Party may use or disclose Confidential Information to
the extent such use or disclosure is reasonably necessary in
complying with any applicable law, regulation or court order or in
conducting clinical trials or in connection with seeking, enforcing
or defending Patent Rights covering Program Inventions;
provided that if the
receiving Party is required to make any such disclosure of
Confidential Information, other than pursuant to a confidentiality
agreement, it will give reasonable advance notice to the disclosing
Party of such disclosure and will use its reasonable efforts to
secure confidential treatment of such Confidential Information
prior to its disclosure (whether through protective orders or
otherwise). Notwithstanding the foregoing, TACTIC may use and
disclose the Confidential Information of XOMA as reasonably
necessary in connection with the exercise of TACTIC’s rights
under Section 2.1(a) and otherwise with respect to the development
or exploitation of TACTIC Program Inventions and Patent Rights,
including, without limitation, to actual or prospective business
partners, investors, contractors, and sublicensees of TACTIC, in
each case, pursuant to a confidentiality agreement with terms
substantially consistent with, and at least as stringent as, those
set forth in this Agreement.

 

4.3 Confidential
Terms. Except as expressly
provided herein, each Party agrees not to disclose any terms of
this Agreement to any Third Party without the consent of the other
Party; provided
that disclosures may be made as
required by securities or other applicable laws, or as reasonably
necessary to actual or prospective business partners, investors and
Tactic's sublicensees under this Agreement pursuant to a
confidentiality agreement with terms at least as stringent as those
in this Agreement, or to a Party's accountants, attorneys and other
professional advisors owing a contractual or other duty of
confidentiality to such Party. Upon the reasonable written request
of the disclosing Party, the receiving Party shall promptly return
or destroy, and certify the same in writing, all Confidential
Information of the other Party; provided that the receiving Party may retain one (1) copy
of any such Confidential Information in its files for purposes of
maintaining appropriate records of its activities in connection
with this Agreement.

 

 

 

4.4 Use of Name. Neither Party
shall use the name or trademarks of the other Party, except to the
extent that a Party is permitted to use the Confidential
Information of the other Party or required to do so pursuant to
this Article 4, without the prior written consent of such other
Party, such consent not to be unreasonably withheld or
delayed.

 

4.5 Previous Agreements. The
parties acknowledge and understand that the Prior Agreement is now
void and superseded by this Agreement.

 

ARTICLE
5

 

 

 

PATENT RIGHTS

 

5.1 Prosecution and Maintenance of TACTIC
and XOMA Patent Rights. TACTIC shall have sole and exclusive
responsibility for Patent Prosecution of all TACTIC Patent Rights.
XOMA shall have sole and exclusive responsibility for Patent
Prosecution of XOMA Patent Rights. In each such case, the
non-prosecuting Party will provide the prosecuting Party with such
assistance and execute such documents as are reasonably necessary
to permit or continue such Patent Prosecution by the prosecuting
Party. The prosecuting Party shall bear all Patent Prosecution
expenses, including attorneys’ fees, incurred by such Party,
or by the other Party at the request of the prosecuting Party, in
the performance of Patent Prosecution.

 

5.2 Enforcement of TACTIC and XOMA Patent
Rights.

 

5.2.1                      Notifications.
Each Party shall provide to the other Party copies of (a) any
written notices it receives from any Third Party regarding any
patent nullity action, declaratory judgment action, alleged
invalidity, unenforceability, infringement or non-infringement with
respect to or alleged misappropriation of intellectual property
with respect to Program Inventions, or the TACTIC Patent Rights,
and (b) any written allegations it receives from a Third Party that
the manufacture, use, sale, offer for sale or import of Product
infringes the Intellectual Property Rights of such Third Party, in
each case promptly following receipt thereof.

 

5.2.2                      Infringement
Proceedings Against Third Parties. TACTIC shall have the
sole and exclusive right, but not the obligation, to institute and
direct legal proceedings against any Third Party believed to be
infringing the TACTIC Patent Rights. XOMA shall have the sole and
exclusive right, but not the obligation, to institute and direct
legal proceedings against any Third Party believed to be infringing
any XOMA Patent Rights. Each Party will bear all of its own costs,
including attorneys’ fees, relating to such legal
proceedings; provided that
the Party directing such legal proceedings shall bear the other
Party’s out-of-pocket expenses, including attorneys’
fees, incurred in complying with requests for cooperation made by
the directing Party. Without limiting the foregoing, any recovery
in connection with such suit or proceeding will be retained solely
by the Party directing such suit or proceeding.

 

 

 

5.3 Infringement Proceedings by Third
Parties. In the event that a Party receives written notice
that it or any of its Affiliates have been individually named as a
defendant in a legal proceeding by a Third Party alleging
infringement or misappropriation of a Third Party Intellectual
Property Right as a result of the manufacture, use, sale, offer for
sale or import of a Product or the XOMA Materials, such Party shall
promptly notify the other Party in writing. Such written notice
shall include a copy of any summons or complaint (or the equivalent
thereof) received regarding the foregoing.

 

5.4 Cooperation. Each Party hereby
agrees:

 

(a) 

to cooperate in the
Patent Prosecution of any inventions within the Program Inventions
;

 

(b) 

to take all
reasonable additional actions and execute such agreements,
instruments and documents as may be reasonably required to perfect
the other Party’s ownership interest in the XOMA Materials
and the Program Inventions in accordance with the intent of this
Agreement;

 

(c) 

to provide comments
and suggestions, as reasonably requested by the other Party, with
respect to copies of drafts of material filings with or other
submissions to the U.S. Patent and Trademark Office or any foreign
counterpart (the “PTO”) relating to Patent
Prosecution, or the court or other tribunal relating to any
infringement claims against Third Parties under the TACTIC Patent
Rights or the defense of infringement or misappropriation claims by
Third Parties relating to Product;

 

(d) 

to cooperate, as
reasonably necessary, with the other Party in gaining patent term
extensions, supplemental protection certificates or their
equivalents wherever applicable to TACTIC Patent
Rights;

 

5.5 No Other Technology Rights.
Except as otherwise provided in this Agreement, under no
circumstances shall a Party, as a result of this Agreement, obtain
any ownership interest or other right in any invention, discovery,
Composition of Matter or other technology, or in any other
Intellectual Property Right, of the other Party (including without
limitation those owned, controlled or developed by the other Party
at any time pursuant to this Agreement).

 

ARTICLE
6

 

 

 

REPRESENTATIONS AND WARRANTIES

 

6.1 Each Party hereby
represents and warrants to the other Party as follows:

 

6.1.1 Existence.
Such Party is duly organized, validly existing and in good standing
under the laws of the jurisdiction in which it is
organized.

 

6.1.2 Authorization
and Enforcement of Obligations. Such Party (a) has the
requisite power and authority and the legal right to enter into
this Agreement and to perform its obligations hereunder, and (b)
has taken all necessary action on its part to authorize the
execution and delivery of this Agreement and the performance of its
obligations hereunder. This Agreement has been duly executed and
delivered on behalf of such Party, and constitutes a legal, valid,
binding obligation, enforceable against such Party in accordance
with its terms.

 

 

 

6.1.3 Consents.
All necessary consents, approvals and authorizations of all
governmental authorities and other Persons required to be obtained
by such Party in connection with this Agreement have been
obtained.

 

6.1.4 No
Conflict. The execution and delivery of this Agreement and
the performance of such Party’s obligations hereunder (a) do
not conflict with or violate any requirement of applicable laws or
regulations and (b) do not conflict with, or constitute a default
under, any contractual obligation of such Party.

 

6.1.5 Additional Representations of
TACTIC. TACTIC further represents and warrants that (a)
TACTIC was formed upon the
dissolution of ATTENUON, such that TACTIC can be considered a
lawful successor of ATTENUON; (b) TACTIC is the successor and rightful owner of
certain IP rights developed by ATTENUON, including, but not limited
to, ATN-658; (c) TACTIC will have in place by the start of a
Phase I clinical trial general liability and product liability
insurance with respect to the research, development and
commercialization of the TACTIC Target, the TACTIC Antibody and
Human EngineeredTM TACTIC Antibodies in such amounts as are
reasonable and customary in the biopharmaceutical industry and
covenants that it shall maintain appropriate general liability and
product liability insurance with respect thereto in such amounts
for so long as such research, development and commercialization
continues and thereafter for so long as is reasonable and customary
in the biopharmaceutical industry, and (d) TACTIC and its
Affiliates will have in place by the start of a Phase I clinical
trial appropriate policies and procedures intended to assure that
Confidential Information of XOMA, or other material non-public
information of XOMA, delivered or otherwise made available to
TACTIC will not be used by TACTIC or its officers, directors,
employees or agents in connection with any activity that would
constitute a criminal or civil violation of United States
securities laws and/or the regulations of the U.S. Securities and
Exchange Commission and, for so long as any provision of this
Agreement remains in effect, TACTIC covenants that it shall
maintain and enforce such policies and procedures and shall not
disclose any such Confidential Information of XOMA, or other
material non-public information of XOMA, to TACTIC's Affiliates who
do not then maintain and enforce such policies.

 

 

6.2 DISCLAIMER
OF WARRANTIES. EXCEPT AS OTHERWISE SET FORTH IN SECTION 6.1
OF THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR
WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE ANTIBODIES AND
OTHER INFORMATION DELIVERED OR TO BE DELIVERED PURSUANT TO THE
PRIOR AGREEMENT OR THE PROGRAM INVENTIONS, INCLUDING WITHOUT
LIMITATION ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE OR NON-INFRINGEMENT OF THE PATENT RIGHTS OR
OTHER INTELLECTUAL PROPERTY RIGHTS OF ANY OTHER
PERSON.

 

 

 

[***] = Confidential Information has been
omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

ARTICLE
7

 

 

 

TERM
AND TERMINATION

 

7.1 Term. Subject to
Sections 7.5 and 7.6 hereof, the term of this Agreement will
commence on the Effective Date and shall remain in full force and
effect until the expiration of all obligations of TACTIC under
Article 3, unless earlier terminated pursuant to 7.2 or 7.3 (the
period from the Effective Date through such expiration or earlier
termination being referred to herein as the “Term”). Upon such
expiration, TACTIC shall be deemed to have a fully paid-up license
to the rights set forth in Section 2.1.

 

7.2 Termination for Material
Breach. This Agreement may be terminated by the
non-breaching Party if the other Party is in breach of its material
obligations under this Agreement and after receiving notice
describing such breach in reasonable detail and requesting its cure
has not cured such breach within [***] days (in the case of a
payment breach with respect to any amount not being disputed in
good faith) or [***] days (in the case of a non-payment breach).
Notwithstanding the foregoing sentence of this Section 7.2: (a) if
such breach is cured or shown to be non-existent within the
aforesaid [***] days or [***] day period, the notice shall be
deemed automatically withdrawn and of no effect and the notifying
Party shall provide written notice to the breaching Party of the
withdrawal; and (b) without limiting the effects of the following
sentence of this Section 7.2, in the event of a good faith dispute
with respect to the existence of a material breach, the [***] day
or [***] day cure period shall be tolled until such time as the
dispute is resolved pursuant to Article 10. The Parties acknowledge
that any failure by XOMA to provide a Human EngineeredTM
TACTIC Antibody that meets the Success Criteria or that meets any
other technical objectives shall not in and of itself be deemed a
material breach of this Agreement.

 

7.3 Termination For Convenience.
This Agreement may be terminated without cause at any time upon
sixty (60) days prior written notice by TACTIC to XOMA, at
TACTIC’s discretion.

 

7.4 Contested Validity.
If TACTIC, a TACTIC successor, a TACTIC sublicensee of the rights
granted hereunder, or a person or entity Controlled by any of the
preceding entities, intends to challenge the validity or
enforceability of any of the XOMA Patent Rights, whether through a
declaratory judgment action, opposition, post-grant proceeding or
otherwise, then such entity shall: (a) [***] and (b)
[***].

 

 

7.5 Effect of
Termination.

 

7.5.1 Termination
of this Agreement shall not release either Party hereto from any
liability (including, without limitation, any payment obligation)
which, at the time of such termination, has already accrued to the
other Party or which is attributable to a period prior to such
termination nor preclude either Party from pursuing any rights and
remedies it may have hereunder or at law or in equity with respect
to any breach of this Agreement.

 

 

 

[***] = Confidential Information has been
omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

7.5.2 Upon
any termination of this Agreement, TACTIC and XOMA shall (a)
promptly return to the other Party all Confidential Information
received from the other Party (except that each Party may retain
one copy for its files solely for the purpose of determining its
rights and obligations hereunder) or (b) destroy all such
Confidential Information with the other Party’s
consent.

 

Notwithstanding the survival of Article 2 as set
forth in Section 7.6 below, (a) the rights and licenses of TACTIC
under Section 2.1 shall terminate and be of no further force or
effect, and (b) TACTIC (on behalf of itself, its Affiliates, and
its successors and assigns) shall not (i) practice or exercise any
invention claimed in, or license, authorize or otherwise allow any
Third Party to practice or exercise such invention claimed in, any
XOMA Patent Rights or (ii) except as reasonably necessary to comply
with applicable law, regulation or court order as provided in
Section 4.2, use or disclose, or authorize or otherwise
allow the use or disclosure of, the XOMA Deliverables, upon (A)
termination of this Agreement by TACTIC pursuant to Section 7.3;
(B) termination of this Agreement by XOMA pursuant to Section 7.2
based on TACTIC 's failure to pay any amount due under Article 3
hereof and not being disputed in good faith; or (C) TACTIC 's
failure to pay a sum that had been disputed in good faith by the
Parties (together with all accrued interest due thereon under this
Agreement) within [***] days after a final determination by an
arbitrator pursuant to Section 9.3 that such amount is due under
this Agreement..

 

7.5.3 Nothing
herein shall in any way limit or restrict XOMA’s ability to
seek and obtain money damages, injunctive relief or any other
remedy, whether at law or in equity, that may be available from or
awarded by a court of competent jurisdiction based on, arising out
of or relating to any breach of this Agreement by
TACTIC.

 

7.5.4  Notwithstanding
anything to the contrary herein, XOMA shall not, at any time during
the Term or thereafter, use, or authorize or otherwise allow the
use of any Human EngineeredTM TACTIC Antibody.

 

7.6 Survival. Sections 3.5, 7.5 and
7.6, and Articles 1, 2 (including, subject to Section 7.5.2, all
rights and licenses therein), 4, 5, 6, 8, 9, 10 and 11 of this
Agreement shall survive any termination hereof.

 

ARTICLE
8

 

 

 

INDEMNITY

 

8.1 Indemnity.

 

8.1.1 By
XOMA. XOMA shall indemnify and hold TACTIC harmless, and
hereby forever releases and discharges TACTIC, from and against all
losses, liabilities, damages and expenses (including reasonable
attorneys’ fees and costs) resulting from all claims,
demands, actions and other
proceedings by any Third Party to the extent arising from (a) the
breach of any representation, warranty or covenant
of XOMA under this or the Prior Agreement, (b)  a claim that the processes or
technologies used by XOMA in the performance of its activities
under the Prior Agreement (other than any such claim with respect
to the CMV promoter), including, without limitation, Human
EngineeringTM activities, infringe the Intellectual Property
Rights of such Third Party (other than Intellectual Property Rights
to the TACTIC Target, any Antibody to the TACTIC Target (including
any Product), or (c) the gross negligence or willful
misconduct of XOMA, its Affiliates or sublicensees in the performance of its obligations, and its
permitted activities, under this or the Prior Agreement; in each case except to the
extent arising from the gross negligence or willful misconduct of
ATTENUON or TACTIC

 

 

 

8.1.2 By
TACTIC. TACTIC shall indemnify and hold XOMA harmless, and
hereby forever releases and discharges XOMA, from and against all
losses, liabilities, damages and expenses (including reasonable
attorneys’ fees and costs) resulting from all claims,
demands, actions and other proceedings by any Third Party to the
extent arising from (a) the breach of any representation, warranty
or covenant of ATTENUON or TACTIC under this or the Prior
Agreement, (b) excluding losses,
liabilities, damages and expenses covered by XOMA pursuant to
Section 8.1.1(b), the making, having made, using, offering
for sale, selling or importing of any Antibody to the TACTIC Target
(including without limitation any Human EngineeredTM TACTIC
Antibody or Product) by ATTENUON, TACTIC, its Affiliates or
licensees or by XOMA pursuant to the terms of this Agreement, (c)
the use of the TACTIC Target or the
ATTENUON Deliverables by XOMA pursuant to the terms of the Prior
Agreement or (d) the gross negligence or willful misconduct
of ATTENUON, TACTIC, their Affiliates or licensees in the
performance of its obligations, and its permitted activities, under
this or the Prior Agreement; in each case except to the extent
arising from (i) a claim that the
processes used by XOMA in the performance of Human
EngineeringTM infringe the Intellectual Property Rights of
such Third Party (other than Intellectual Property Rights to the
TACTIC Target, any Antibody to the TACTIC Target, or (ii)
the gross negligence or willful misconduct of XOMA.

 

8.2 Procedure. A Party (the
“Indemnitee”) that intends
to claim indemnification under this Article 8 shall promptly notify
the other Party (the “Indemnitor”) of any
claim, demand, action or other proceeding for which the Indemnitee
intends to claim such indemnification. The Indemnitor shall have
the right to participate in, and to the extent the Indemnitor so
desires, to assume the defense thereof with counsel selected by the
Indemnitor; provided,
however, that the Indemnitee shall have the right to retain
its own counsel, with the fees and expenses to be paid by the
Indemnitor, if representation of the Indemnitee by the counsel
retained by the Indemnitor would be inappropriate due to actual or
potential differing interests between the Indemnitee and any other
Party represented by such counsel in such proceeding. The indemnity
obligations under this Article 8 shall not apply to amounts paid in
settlement of any claim, demand, action or other proceeding if such
settlement is effected without the prior express written consent of
the Indemnitor, which consent shall not be unreasonably withheld or
delayed. The failure to deliver notice to the Indemnitor within a
reasonable time after notice of any such claim or demand, or the
commencement of any such action or other proceeding, if prejudicial
to its ability to defend such claim, demand, action or other
proceeding, shall relieve such Indemnitor of any liability to the
Indemnitee under this Article 8 with respect thereto, but the
omission so to deliver notice to the Indemnitor shall not relieve
it of any liability that it may have to the Indemnitee otherwise
than under this Article 8. The Indemnitor may not settle or
otherwise consent to an adverse judgment in any such claim, demand,
action or other proceeding that diminishes the rights or interests
of the Indemnitee without the prior express written consent of the
Indemnitee, which consent shall not be unreasonably withheld or
delayed. The Indemnitee, its employees and agents shall reasonably
cooperate with the Indemnitor and its legal representatives in the
investigation and defense of any claim, demand, action or other
proceeding covered by this Article 8.

 

 

 

[***] = Confidential Information has been
omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

ARTICLE
9

 

 

 

DISPUTE RESOLUTION

 

9.1 Attempts to Amicably Resolve
Disputes. If any dispute, controversy or claim is initiated
by either Party arising out of, resulting from or relating in any
way to this Agreement, the performance by either Party of its
obligations under this Agreement or the subject matter of this
Agreement (a “Dispute”), then the
Parties shall attempt to resolve such Dispute as follows. The Party
initiating the Dispute shall give written notice to the other
Party specifying in
reasonably specific detail the basis for such Dispute. Following
receipt of such notice, the Parties shall refer the Dispute to
their respective chief executive officers (or their designees) for
resolution. The Parties’ respective chief executive officers
(or their designees) shall meet (in person, by videoconference or
by telephone as mutually agreed upon by the Parties) to attempt to
reach a mutually acceptable resolution of the Dispute.

 

9.2 Mediation. Subject to Section
9.4, if a Dispute is not resolved in the manner set forth in
Section 9.1 within [***]
days after receipt of notice under Section 9.1, the Parties agree
to try in good faith to resolve such dispute in an expeditious
manner by mediation administered by the CPR Institute for Dispute
Resolution or its successor organization (“CPR”) in accordance with
its mediation procedure. The mediation proceeding shall be
conducted at the location of the Party not originally requesting
the resolution of the Dispute. The Parties agree that they shall
share equally the cost of the mediation filing and hearing fees and
the cost of the mediator. Each Party must bear its own
attorney’s fees and associated costs and expenses. For the
avoidance of doubt, nothing in connection with such mediation shall
be binding on either Party, except for the provisions regarding
sharing of costs set forth in this Section 9.2.

 

9.3 Arbitration.

 

9.3.1 Subject
to Section 9.4, any Dispute that is not resolved in the manner set
forth in Section 9.2 within [***] days after referral to
mediation under Section 9.2 shall be finally resolved by binding
arbitration, as set forth in this Section 9.3.

 

9.3.2 Whenever
a Party shall decide to institute arbitration proceedings, it shall
give written notice to that effect to the other Party. Any such
arbitration shall be conducted under the Commercial Arbitration
Rules of the American Arbitration Association by a panel of one (1)
arbitrator appointed in accordance with such rules to be appointed
within [***] days of such notice. Such arbitrator shall have no
less than [***] of experience directly in the field of
biotechnology licensing, and shall be available to serve under the
geographic and time constraints set forth herein and in Section
9.3.3. Any such arbitration shall be held in New York, New
York.

 

 

 

[***] = Confidential Information has been
omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

9.3.3 The
arbitrator shall be jointly instructed by the Parties in writing to
set a schedule that will enable them to complete all proceedings
and render their award within [***] days from the date of
appointment of the arbitrator in accordance with Section 9.3.2. For
good cause shown, the arbitrator may extend this schedule for up
to, but in no event more than, [***] additional days. The failure
of the arbitrator to render a final award within the foregoing time
frame shall not give rise to a jurisdictional defect, but this fact
shall not be disclosed to the arbitrators until after the
expiration of such [***] day period. The arbitrator shall have the
authority to grant specific performance in such equitable manner as
they determine. The prevailing Party in any such arbitration (as
determined by the arbitrator) shall be entitled to recover its
reasonable attorneys’ fees and expenses incurred in
connection with such arbitration. Judgment upon the award so
rendered may be entered in any court having jurisdiction as
provided in Section 9.5 or application may be made to such court
for judicial acceptance of any award and an order of enforcement,
as the case may be.

 

9.3.4 In
no event shall a demand for arbitration be made after the date when
institution of a legal or equitable proceeding based upon such
claim, dispute or other matter in question would be barred by the
applicable statute of limitations.

 

9.3.5 Notwithstanding
the foregoing, either Party shall have the right, without waiving
any right or remedy available to such Party under this Agreement or
otherwise, to seek and obtain from any court of competent
jurisdiction any interim or provisional relief that is necessary or
desirable to protect the rights or property of such Party, pending,
the selection of the arbitrators hereunder or pending the
arbitrators’ determination of any dispute, controversy or
claim hereunder.

 

9.4 Disputes Regarding Patents.
Notwithstanding any provision hereof to the contrary, any Dispute
relating to the determination of ownership, validity,
enforceability or infringement by the other Party of a
Party’s patents shall, if not resolved in the manner set
forth in Section 9.1 within [***] days after receipt of
notice under Section 9.1, be submitted exclusively to the federal
courts located in New York, New York , and the Parties hereby
consent to the jurisdiction and venue of such court.

 

9.5 Venue;
Jurisdiction.

 

9.5.1 Any
action or proceeding brought by either Party seeking to enforce any
provision of, or based on any right arising out of, this Agreement
must be brought against either Party in the courts of the State of
New York. Each Party (i) hereby irrevocably submits to the
jurisdiction of the state courts of the State of New York and to
the jurisdiction of any United States District Court in the State
of New York , for the purpose of any suit, action, or other
proceeding arising out of or based upon this Agreement or the
subject matter hereof brought by any Party or its successors or
assigns, (ii) hereby waives, and agrees not to assert, by way of
motion, as a defense, or otherwise, in any such suit, action, or
proceeding, any claim that it is not subject personally to the
jurisdiction of the above-named courts, that its property is exempt
or immune from attachment or execution, that the suit, action or
proceeding is brought in an inconvenient forum, that the venue of
the suit, action, or proceeding is improper or that this Agreement
or the subject matter hereof may not be enforced in or by such
court, and (iii) hereby waives and agrees not to seek any review by
any court of any other jurisdiction that may be called upon to
grant an enforcement of the judgment of any such Illinois state or
federal court.

 

 

 

9.5.2 Process
in any action or proceeding seeking to enforce any provision of, or
based on any right arising out of, this Agreement may be served on
any Party anywhere in the world. Each Party consents to service of
process by registered mail at the address to which notices are to
be given pursuant to Section 11.4. Nothing herein shall affect the
right of a Party to serve process in any other manner permitted by
applicable law. Each Party further agrees that final judgment
against it in any such action or proceeding arising out of or
relating to this Agreement shall be conclusive and may be enforced
in any other jurisdiction within or outside the United States of
America by suit on the judgment, a certified or exemplified copy of
which shall be conclusive evidence of the fact and of the amount of
its liability.

 

9.5.3 Each
Party agrees that it shall not, and that it shall instruct those in
its control not to, take any action to frustrate or prevent the
enforcement of any writ, decree, final judgment, award (arbitral or
otherwise) or order entered against it with respect to this
Agreement, and shall agree to be bound thereby as if issued or
executed by a competent judicial tribunal having personal
jurisdiction situated in its country of residence or
domicile.

 

ARTICLE
10

 

 

 

SUCCESSORS AND ASSIGNS

 

10.1 Limited
Right to Assign. Neither TACTIC nor XOMA may transfer or
assign this Agreement or any of its rights hereunder without the
written consent of the other;
provided,
however, that (a) XOMA may,
without such consent, assign this Agreement and its rights and
obligations hereunder to a Third Party only in connection with the
transfer or sale of all or substantially all of its business
relating to Human EngineeringTM, or in the event of a merger,
consolidation or other transaction resulting in a change in control
of XOMA, and (b) TACTIC may, without such consent, assign this
Agreement and its rights and obligations hereunder to a Third Party
only in connection with the transfer or sale of a Human
EngineeredTM version of a TACTIC Antibody or all or
substantially all of its assets relating to its anti-uPAR
monoclonal antibodies or in the event of a merger, consolidation or
other transaction resulting in a change in control of TACTIC. Any
attempted transfer or assignment in violation of this Section 10.1
shall be void. Nothing herein shall prohibit any transfer or
assignment by either TACTIC or XOMA to or among any of their
respective Affiliates.

 

10.2 Permitted
Successors and Assigns. This Agreement shall be binding upon
and inure to the benefit of the Parties and their successors and
assigns as permitted in Section 10.1.

 

ARTICLE
11

 

 

 

MISCELLANEOUS

 

11.1 Governing
Law. This Agreement and any dispute arising from the
performance or breach hereof shall be governed by and construed and
enforced in accordance with the laws of the State of New York,
without reference to conflicts of laws principles.

 

 

 

[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

11.2 Bankruptcy.
All rights and licenses granted under or pursuant to this Agreement
by one Party to the other are, for all purposes of Section 365(n)
of Title XI of the United States Code (“Title XI”), licenses of
rights to “intellectual property” as defined in Title
XI. During the Term each Party shall create and maintain current
copies to the extent practicable of all such intellectual property.
If a bankruptcy proceeding is commenced by or against one Party
under Title XI, the other Party shall be entitled to a copy of any
and all such intellectual property and all embodiments of such
intellectual property, and the same, if not in the possession of
such other Party, shall be promptly delivered to it (a) upon such
Party’s written request following the commencement of such
bankruptcy proceeding, unless the Party subject to such bankruptcy
proceeding, or its trustee or receiver, elects within [***] days to
continue to perform all of its obligations under this Agreement, or
(b) if not delivered as provided under clause (a) above, upon such
other Party’s request following the rejection of this
Agreement by or on behalf of the Party subject to such bankruptcy
proceeding. If a Party has taken possession of all applicable
embodiments of the intellectual property of the other Party
pursuant to this Section 11.2 and the trustee in bankruptcy of the
other Party does not reject this Agreement, the Party in possession
of such intellectual property shall return such embodiments upon
request. If a Party seeks or involuntarily is placed under Title XI
and the trustee rejects this Agreement as contemplated under 11
U.S.C. 365(n)(1), the other Party hereby elects, pursuant to
Section 365(n) of Title XI, to retain all rights granted to it
under this Agreement to the extent permitted by law.

 

11.3 Waiver.
No waiver of any rights shall be effective unless consented to in
writing by the Party to be charged and the waiver of any breach or
default shall not constitute a waiver of any other right hereunder
or any subsequent breach or default.

 

11.4 Notices.
All invoices, notices, requests and other communications hereunder
shall be in writing and shall be delivered or sent in each case to
the respective address specified below, or such other address as
may be specified in writing to the other Party hereto, and shall be
effective on receipt.

 

If to
TACTIC: 

Tactic Pharma,
LLC

 

   
           
           
           
           
           
         
[***]

 

   
           
           
           
           
           
        Attention: Andrew Mazar,
CSO.

 

With a copy
to: 

Baker &
Hostetler, LLP 2929 Arch Street

 

Cira
Centre – 12th Floor

 

Philadelphia, PA
19004

 

Attention: Tactic
Pharma Legal Counsel, Dr. Jeffrey H. Rosedale

 

If to
XOMA: 

XOMA (US)
LLC

 

   
           
           
           
           
           
         2910 Seventh
Street

 

   
           
           
           
           
           
        Berkeley, California
94710

 

   
           
           
           
           
           
        Attention: Legal
Department

 

 

 

with a copy
to: 

XOMA (US)
LLC

 

   
           
           
           
           
           
          2910 Seventh
Street

 

   
           
           
           
           
           
          Berkeley, California
94710

 

   
           
           
           
           
           
          Attention: Legal
Department

 

11.5 Independent
Contractors. The Parties are independent contractors under
this Agreement. Nothing contained in this Agreement is intended nor
is to be construed so as to constitute TACTIC or XOMA as partners
or joint venturers with respect to this Agreement. Except as
expressly provided for by this Agreement, no Party shall have any
express or implied right or authority to assume or create any
obligations on behalf of or in the name of any other Party or to
bind any other Party to any other contract, agreement or
undertaking with any Third Party.

 

11.6 Force
Majeure. A Party shall neither be held liable or responsible
to the other Party, nor be deemed to have defaulted under or
breached this Agreement, for failure or delay in fulfilling or
performing any obligation under this Agreement (other than an
obligation for the payment of money) to the extent, and for so long
as, such failure or delay is caused by or results from causes
beyond the reasonable control of such Party, including but not
limited to fire, floods, embargoes, war, acts of war (whether war
be declared or not), insurrections, riots, civil commotions,
strikes, lockouts or other labor disturbances, acts of God or acts,
omissions or delays in acting by any governmental authority or
other Party.

 

11.7 Other
Activities. Except as otherwise expressly provided in this
Agreement, nothing in this Agreement shall preclude either Party
from conducting other programs (either for its own benefit or with
or for the benefit of any other Person) to conduct research, or to
develop or commercialize products or services, for use in any
field.

 

11.8 Headings.
The captions to the several sections hereof are not a part of this
Agreement, but are included merely for convenience of reference
only and shall not affect its meaning or
interpretation.

 

11.9 Entire
Agreement; Amendment.

 

11.9.1 This
Agreement constitutes the entire and exclusive agreement between
the Parties with respect to the subject matter hereof and
supersedes and cancels all previous discussions, agreements,
representations, commitments and writing in respect
thereof.

 

11.9.2 No
amendment or addition to this Agreement shall be effective unless
reduced to writing and executed by the authorized representatives
of the Parties.

 

11.10 Illegality;
Unenforceability. In the event that any provision of this
Agreement shall be determined to be illegal or unenforceable, that
provision will be limited or eliminated to the minimum extent
necessary so that this Agreement shall otherwise remain in full
force and effect and enforceable.

 

11.11 Counterparts.
This Agreement may be executed in counterparts, each of which shall
be deemed to be an original and together shall be deemed to be one
and the same agreement.

 

[SIGNATURE PAGE
FOLLOWS ]

 

 

 

 

 

 

IN
WITNESS WHEREOF, the Parties have executed this Agreement as of the
date first set forth above.

 

 

 

	

         TACTIC PHARMA,
LLC

 

 

 

By: /s/ Andrew
Mazar

Andrew
Mazar

           
Chief Scientific Officer

 

	

XOMA
(US) LLC

 

 

 

By: /s/ James
Neal

James R. Neal

VP, Business Development & Program
Leadership

 

 

 

[***] = Confidential Information has been
omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

Schedule
1.16

 

Human EngineeringTM Patent Rights

 

Title: 

[***]

Inventors:                                Studnicka,
Little, Fishwild, Kohn

 

 

Based
on [***].

 

	

COUNTRY

	

SERIAL NO.

	

PATENT NO.

	

EXPIRES

	

[***]

	

[***]

	

[***]

	
[***]

 

[***]

 

 

 

 

 

 

-1-Blueprint

 

 

 

 

[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

 

 

VALIDIVE®
OPTION AND LICENSE AGREEMENT

 

BY AND
BETWEEN

 

MONOPAR
THERAPEUTICS INC.

 

AND

 

ONXEO S.A.
 

            

 

 

 

 

 

 

 

 

 

 

TABLE OF CONTENTS

 

	

1.

	

DEFINITIONS AND
INTERPRETATION

	

2

	

2,

	

MONOPAR VALIDIVE OPTION; MONOPAR DEVELOPMENT AND
COMMERCIALIZATION

	

11

	

3

	

LICENSES; TECHNOLOGY TRANSFER; EXCLUSIVITY

	

16

	

4

	

FINANCIAL TERMS

	

18

	

5

	

INTELLECTUAL PROPERTY

	

22

	

6

	

WARRANTIES AND LIMITATION OF LIABILITY

	

25

	

7

	

INDEMNITY AND INSURANCE

	

27

	

8

	

CONFIDENTIALITY

	

29

	

9

	

TERM AND TERMINATION

	

31

	

10

	

DISPUTE RESOLUTION

	

37

	

11

	

MISCELLANEOUS

	

38

 

	

SCHEDULE
1

	

Licensed
Patents

	

SCHEDULE
2

	

Licensed
Know-How

	

SCHEDULE
3

	

Licensed
Trademarks

	

SCHEDULE
4

	

Validive
Materials

	

SCHEDULE
5

	

Confirmatory
Patent License

 

 

 

 

OPTION AND LICENSE AGREEMENT

 

THIS OPTION AND LICENSE AGREEMENT (together with any
Schedules attached hereto, this “Agreement”) is made and
entered into as of June 17, 2016 (the “Effective Date”), by and
between Monopar Therapeutics Inc., a Delaware corporation located
at 598 Rockefeller Rd, Lake Forest, Illinois 60201, United States
of America (“Monopar”), and Onxeo S.A., a
French société anonyme
à Conseil d’administration located at 49,
boulevard du Général Martial Valin, 75015 Paris, France
(“Onxeo”).
Monopar and Onxeo are sometimes referred to herein individually as
a “Party” and collectively as the
“Parties.”

 

 

RECITALS

 

WHEREAS:

 

(A) 

Onxeo owns Patents, Trademark registrations and
other proprietary rights relating to Validive® (as
defined below). At this time, Onxeo does not intend to undertake
any further development of Validive®.

 

(B) 

Monopar
has expertise in research, development, and commercialization of
pharmaceutical products.

 

(C) 

Onxeo desires to grant, and Monopar desires to
obtain, an exclusive option to take a license to research, develop,
and commercialize Validive® on an
exclusive basis for any and all uses in the Field in the Territory
(each, as defined below), all on the terms and conditions set forth
herein.

 

(D) 

Upon exercise by Monopar of the option for the
license for Validive®, Onxeo
desires to grant Monopar, and Monopar desires to obtain, an
exclusive license in the Field in the Territory to use, sell, offer
for sale, import, and make or have made Licensed Products (as
defined below) in the Field in the Territory on the terms and
conditions set forth herein.

 

 

 

 

AGREEMENT

 

NOW IT IS HEREBY AGREED as follows:

 

 

1.

DEFINITIONS AND
INTERPRETATION

 

1.1

In this Agreement
the words and phrases set out below shall, unless the context
requires otherwise, have the corresponding meaning attributed to
them below.

 

“Active Party” has the
meaning set forth in
Section 5.3.5.

 

“Affiliate” means with
respect to a given entity, any person, corporation, partnership or
other entity, that Controls, is Controlled by, or is under common
Control with such entity.

 

“Agreement” means this
agreement and each of the Schedules as amended from time to time in
accordance with Section 11.3.

 

“Arising Intellectual
Property” means all Intellectual Property, including
Know-How, conceived, created or invented after the Effective Date
by or on behalf of either Party; and any Patents which claim any
inventions described or comprised in such Know-How, but excluding
Intellectual Property, including Know-How, comprised in the
Licensed Intellectual Property.

 

“Audit for Cause” has the
meaning set forth in Section 2.2.3.

 

“Bankruptcy Code” has the
meaning set forth in Section 9.4.

 

“Breaching Party” has he
meaning set forth in Section 9.2.1.

 

“Business Day” means a day
other than a Saturday, Sunday or any public holiday in Paris,
France or New York, New York, United States.

 

“Clinical Data” means any
Know-How that is included in, or supports, a regulatory submission
for approval of the testing of drugs in man or for approval for the
placing of medicinal products on the market (including submissions
to the FDA, the EMA or other competent Regulatory
Authorities).

 

“Combination Product” means
any product that comprises a Licensed Product sold in conjunction
with another active component so as to be a combination product
(whether packaged together or in the same therapeutic
formulation).

 

 

 

“Commencement” means, in
relation to a clinical trial, the date upon which a Licensed
Product is first administered to a human subject, whether such
subject is a healthy volunteer or a patient.

 

“Commercialization” or
“Commercialize”
means activities directed to obtaining pricing and reimbursement
approvals, marketing, promoting, distributing, offering for sale,
or selling a Licensed Product. For clarity,
“Commercialization” shall not include manufacturing
activities, but shall include importation, exportation and use
related to offering for sale or selling a Licensed
Product.

 

“Commercially Reasonable
Efforts” means efforts of a Party to carry out its
obligations in a diligent and sustained manner using such effort
and employing such resources normally used by an established
biopharmaceutical company in the exercise of its reasonable
business discretion relating to the research, development or
commercialization of a similar product owned by such Party or to
which such Party has exclusive rights, with similar product
characteristics, that is of similar market potential at a similar
stage in its development or product life, taking into account
issues of market exclusivity (including Patent coverage and
Regulatory Exclusivity), safety and efficacy, product profile, the
competitiveness of the marketplace, the proprietary position of the
compound or product, the regulatory structure involved, the
profitability of the applicable products (including pricing and
reimbursement status achieved), and other relevant factors,
including technical, legal, scientific, and/or medical
factors.

 

“Confidential Information”
means any information, in tangible or non-tangible form (including
oral disclosure) including Know-How, research and development
plans, information relating to the customers, suppliers, business
partners, clients, finances, business plans and products (in each
case actual or prospective) of a Party, the terms of this
Agreement, and any other technical or business information, which
is obtained by either Party from the other (or its representatives)
pursuant to this Agreement and is marked as confidential, or
indicated by notice as being confidential no more than five (5)
Business Days after its disclosure. Licensed Know-How shall be
deemed the Confidential Information of Onxeo.

 

“Control”
means:

 

(a) 

the possession
(directly or indirectly) of fifty per cent (50%) or more of the
voting stock or other equity interest of a subject entity with the
power to vote, or the power in fact to control the management
decisions of such entity through the ownership of securities or by
contract or otherwise;

 

(b) 

in respect of any
Patent Rights, Know-How or other Intellectual Property whether
owned by or licensed to an entity, the possession of the legal
right and ability to grant the respective licenses or sublicenses
as provided in this Agreement without violating the terms of any
agreement or other arrangement with any Third Party;

 

 

 

 

and
“Controlling”
and “Controlled
by” shall be construed accordingly.

 

“Cure Period” has the
meaning set forth in Section 9.2.1.

 

 “Development” means
pre-clinical and clinical drug development activities reasonably
relating to the discovery and development of pharmaceutical
compounds and submission of information to a Regulatory Authority,
including toxicology, pharmacology, and other discovery and
pre-clinical studies, test method development and stability
testing, manufacturing process development (including validation
test methods and procedures), formulation development, delivery
system development, quality assurance and quality control
development, statistical analysis, clinical trials and activities
relating to obtaining Regulatory Approval, but excluding
Commercialization activities. When used as a verb,
“Develop” means to engage in Development.

 

“Disclosing Party” has the
meaning set forth in Section 8.1.

 

“Effective Date” means the
date this Agreement is made.

 

“EMA” means the European
Medicines Agency or any successor to
it.

 

“Executive Officers” means a
representative of Onxeo authorized by notice to Monopar, and the
Chief Executive Officer of Monopar or such other authorized senior
manager of a Party as may be substituted from time to time upon the
giving of written notice to the other Party.

 

“Extended Exclusivity
Period” means any period during which one of the
following subsists in respect of a Licensed Product: orphan drug
designation or exclusivity, pediatric designation or exclusivity,
new chemical entity exclusivity, or other exclusivity (excluding a
Patent) granted by a Regulatory Authority beyond the expiry of the
relevant Patent.

 

“FDA” means the United
States Food and Drug Administration or any successor to
it.

 

“Field” means any and all
uses.

 

“First Commercial Sale”
means the first transfer of a Licensed Product by Monopar to the first Third
Party (other than a Sublicensee or a distributor) in any country in
the Territory, in exchange for cash or some equivalent to which
value can be assigned for the purpose of determining Net Sales,
after Regulatory Approval of such Licensed Product has been
granted, or such marketing and sale is otherwise permitted, by the
Regulatory Authority of such country, excluding registration
samples, compassionate use, and use in Phase IV
Trials.

 

 

 

 

“Force Majeure” means in
relation to either Party any event or circumstance which is beyond
the reasonable control of that Party, which event or circumstance
that Party could not reasonably be expected to have taken into
account at the Effective Date and which results in or causes the
failure of that Party to perform any or all of its obligations
under this Agreement including an act of God, lightning, fire,
storm, flood, earthquake, strike, lockout or other industrial
disturbance, war, a terrorist act, blockade, revolution, riot,
insurrection, civil commotion, public demonstration, sabotage, act
of vandalism, explosion, provided that lack of funds shall not be
interpreted as a cause beyond the reasonable control of that
Party.

 

“GAAP” shall mean generally
accepted accounting principles as applicable in the United States,
consistently applied; provided that, to the extent that a Party
adopts International Financial Reporting Standards (IFRS), then
“GAAP” means International Financial Reporting
Standards (IFRS), consistently applied.

 

“Inactive Party” has the
meaning set forth in Section 5.3.5.

 

“IND” means an
investigational new drug application filed with the FDA, or an
application filed with any Regulatory Authority outside the United
States of America (including any supranational agency such as the
EMA) necessary to commence human clinical trials in such
jurisdiction.

 

“Indemnified Party” has the
meaning set forth in Section 7.1.3.

 

“Indemnifying Party” has the
meaning set forth in Section 7.1.3.

 

“Indication”
means a disease
classification block as defined within the International
Statistical Classification of Diseases and Related Health Problems
as published from time to time by the World Health Organization
(e.g. “C50 Malignant neoplasm of Breast”, “C92
Myeloid leukemia”, “B20 Human immunodeficiency virus
[HIV] disease resulting in infectious and parasitic
diseases”, “M34 Systemic sclerosis”). For the
avoidance of doubt, therapeutic indications having the same
histology (such as first-line to second-line therapies) do not
constitute a different Indication.

 

“Intellectual Property”
means Patents, Know-How and Trademarks.

 

“Intellectual Property
Rights” means all Patent Rights, rights to Know-How,
copyrights, database rights, design rights, rights in Trademarks
and domain names, and all rights or forms of protection of a
similar nature or having equivalent or similar effect to any of
them which may subsist anywhere in the world, whether or not any of
them are registered including any application for registration of
any of them.

 

 

 

 

“Know-How” means any
unpatented, technical and other information which is not in the
public domain including, ideas, concepts, inventions (whether or
not patentable), discoveries, data, designs, formulae, algorithms,
methods, models, specifications, clinical data, information
relating to biological and chemical structures, properties and
functions as well as methods for synthesizing chemical compounds,
procedures for experiments and tests (including diagnostic tests),
results of experimentation and testing, results of research and
development including laboratory records and data analyses.
Information in a compilation or a compilation of information may be
Know-How notwithstanding that some or all of its individual
elements are in the public domain.

 

“Laws” means all applicable
laws, statutes, rules, regulations, ordinances and other
pronouncements having the effect of law in any federation, nation,
multinational governmental entity, state, province, county, city or
other political subdivision, domestic or foreign.

 

“License Fee” has the
meaning set forth in Section 4.2.

 

“Licensed Intellectual
Property” means the Licensed Know-How, Licensed
Patents and Licensed Trademarks.

 

“Licensed Know-How” means
the Know-How directly and solely relating to the Licensed Product
that is Controlled by Onxeo or its Affiliates at the Effective Date
as further described in SCHEDULE
2.

 

“Licensed Patents” means
Patents further described in SCHEDULE
1.

 

“Licensed Product” means all
products containing clonidine or its analogues, salts, prodrugs,
and any derivatives thereof, formulated using Onxeo’s
Lauriad® technology, including the product referred to as
Validive® or Clonidine Lauriad®.

 

“Licensed Trademarks” means
Trademarks further described in SCHEDULE 3.

 

“Losses” means any cost,
expense or loss actually suffered resulting from any or all claims,
causes of action or demands made by a Third Party, including
reasonable attorneys' fees.

 

“Material” means any
chemical or biological material and any property rights relating to
any of the foregoing other than Intellectual Property
Rights.

 

“Milestone
Event” has the meaning
given in Section 4.3.1.

 

“Milestone
Payment” has the meaning
given in Section 4.3.1

 

“Monopar Indemnified
Parties” means Monopar and its Affiliates and their
respective directors, officers, employees and agents.

 

 

 

[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

“Monopar Validive Option”
has the meaning specified in Section 2.1.

 

“Monopar Validive Option
Period” has the meaning specified in Section 2.1.1.

 

“NDA” means an application
for approval to market a product commercially such as a New Drug
Application filed pursuant to the requirements of the FDA, as more
fully defined in 21 CFR § 314.3 et seq, or a Biologics License
Application filed pursuant to the requirements of the FDA, as more
fully defined in 21 CFR § 601, or a marketing authorization
application filed pursuant to the requirements of European
Directive 2001/83/EC, or any equivalent or similar application
filed with any other Regulatory Authority in any country or region
in the Territory, together, in each case, with all additions,
deletions or supplements thereto.

 

“Net Sales” means the aggregate
gross invoice prices of all Licensed Products sold by Monopar, its
Affiliates or its Sublicensees to Third Parties (that are not
Sublicensees) anywhere within the Territory, including wholesale
distributors, less deductions from such amounts calculated in
accordance with GAAP so as to arrive at net sales under GAAP, and
further reduced by [***] or increased for [***].

 

Any and
all set-offs against gross invoice prices shall be calculated in
accordance with GAAP. Sales or other commercial dispositions of
Licensed Products between Monopar and its Affiliates and its
Sublicensees, and Licensed Products provided to Third Parties
without charge, in connection with research and development,
clinical trials, compassionate use, humanitarian and charitable
donations, or indigent programs or for use as samples shall be
excluded from the computation of Net Sales, and no payments will be
payable on such sales or such other commercial dispositions, except
where such an Affiliate or Sublicensee is an end user of the
Licensed Product.

 

If a
Licensed Product is sold or otherwise commercially disposed of for
consideration other than cash or in a transaction that is not at
arm’s length between the buyer and the seller, then the gross
amount to be included in the calculation of Net Sales shall be the
amount that would have been invoiced had the transaction been
conducted at arm’s length and for cash. Such amount that
would have been invoiced shall be determined, wherever possible, by
reference to the average selling price of the relevant Licensed
Product in arm’s length transactions in the relevant
country.

 

Notwithstanding the
foregoing, in the event a Licensed Product is sold as a Combination
Product, Net Sales shall be calculated by multiplying the Net Sales
of the Combination Product by the fraction A/(A+B), where A is the
gross invoice price of the Licensed Product if sold separately in a
country and B is the gross invoice price of the other product(s)
included in the Combination Product if sold separately in such
country. If no such separate sales are made by Monopar, its
Affiliates or Sublicensees in a country, Net Sales of the
Combination Product shall be calculated in a manner to be
negotiated and agreed upon by the Parties, reasonably and in good
faith, prior to any sale of such Combination Product, which shall
be based upon the respective cost of goods sold of the active
components of such Combination Product. In the event that the
Parties are not able to so agree on the calculation of Net Sales of
the Combination Product within three (3) months after commencement
of such negotiations, the dispute shall be submitted to final and
binding arbitration, as provided in Section 10.3

 

 

 

 

“Non-Breaching Party” has
the meaning set forth in Section 9.2.1.

 

“Onxeo Indemnified Parties”
means Onxeo and its Affiliates and their respective directors,
officers, employees and agents.

 

“Parties” means Monopar and
Onxeo and “Party” shall mean any of
them.

 

“Patents” and “Patent
Rights” means any patent applications, patents, author
certificates, inventor certificates, utility models, and all
foreign counterparts of them and includes all divisionals,
renewals, continuations, continuations-in-part, extensions,
reissues, reexaminations, substitutions, confirmations,
registrations, revalidations and additions of or to them, as well
as any Supplementary Protection Certificate, or any like form of
protection.

 

“Person” means any
individual, firm, corporation, partnership, limited liability
company, trust, business trust, joint venture, Regulatory
Authority, association, or other entity.

 

“Phase III Trial” means a
human clinical trial of a Licensed Product, which trial is
designed: (a) to establish that the Licensed Product is safe and
efficacious for its intended use; (b) to define warnings,
precautions and adverse reactions that are associated with the
Licensed Product in the dosage range to be prescribed; and (c)
consistent with 21 CFR § 312.21(c).

 

“Phase III Clinical Trial
Report” means a full clinical study report in relation
to a Phase III Trial which is written by or on behalf of
Monopar.

 

“Phase IV Trial” means (i)
any clinical trial in humans conducted to satisfy a requirement of
a Regulatory Authority in order to maintain a Regulatory Approval
and (ii) any clinical trial in humans conducted after the first
Regulatory Approval in the same disease state for which the
Licensed Product received Regulatory Approval in the
Territory.

 

 

 

 

“Price Approval” means, in
those countries in the Territory where a Regulatory Authority may
approve or determine pricing and/or pricing reimbursement for
pharmaceutical products, such approval or
determination.

 

“Progress Report”
means a written report
produced by Monopar setting out brief details of: (i) the progress
of development of the Licensed Product; (ii) the progress of any
applications for Regulatory Authorization and (where relevant)
Price Approvals; and (iii) the progress of and plans for marketing
and sale of the Licensed Product.

 

“Prosecution” means the
preparation, filing, procuring, and maintenance of Patents, such as
before national, international, and regional patent offices,
including any interferences, derivation proceedings, reissue
proceedings, reexaminations, and post-grant proceedings (such as
inter partes reviews, post-grant reviews, and oppositions). When
used as a verb, “Prosecute” means to engage in
Prosecution.

 

“Quarter” means any of the
three (3) monthly periods commencing on the first day of any of the
months of January, April, July, and October in any year and
“Quarterly” has
a corresponding meaning.

 

“Receiving Party” has the
meaning set forth in Section 8.1.

 

“Regulatory Approval” means,
with respect to any Licensed Product in any jurisdiction, all
approvals (including Pricing Approvals) from any Regulatory
Authority necessary for the development, commercial manufacture,
marketing and sale of the Licensed Product in such jurisdiction in
accordance with Laws.

 

“Regulatory Authority” means
any national or supranational governmental authority, including the
FDA, EMEA, or Koseisho (i.e., the Japanese Ministry of Health and
Welfare, or any successor agency thereto), that has responsibility
in countries in the Territory over the Development and/or
Commercialization of a Licensed Product.

 

“Regulatory Filings” means
any and all regulatory applications and filings and associated
correspondence made in order to obtain Regulatory
Approvals.

 

“Sublicensee” means a person
to whom a sublicense is granted in accordance with Section 3.2 in respect of the whole or any part of the
rights granted under this Agreement or any person to whom such
Sublicensee grants a sublicense in accordance with Section 3.2.

 

“Supplementary Protection
Certificate” means a right based on a patent pursuant
to which the holder of the right is entitled to exclude Third
Parties from using, making, having made, selling or otherwise
disposing or offering to dispose of, importing or keeping the
product to which the right relates, such as supplementary
protection certificates in Europe, and any similar right anywhere
in the world.

 

 

 

 

“Term” means the term of
this Agreement determined in accordance with Section 9.1.4.

 

“Territory” means any and
all countries in the world.

 

“Third Party” means any
Person other than Monopar, Onxeo and their respective Affiliates
and Sublicensees.

 

“Trademark” means any word,
name, symbol, color, designation, or device or any combination
thereof, whether registered or unregistered, including any
trademark, trade dress, service mark, service name, brand mark,
trade name, brand name, logo, or business symbol.

 

“United States” or
“U.S.” means the
United States of America and all its territories and
possessions.

 

“Valid Claim” means a claim
within an issued United States Patent or any foreign Patent that
has not expired, lapsed, or been cancelled or abandoned, and that
has not been dedicated to the public, disclaimed, or held
unenforceable, invalid, or been cancelled by a court or
administrative agency of competent jurisdiction in an order or
decision from which no appeal has been or can be taken, including,
without limitation, through opposition, reexamination, reissue or
disclaimer; provided that, on a country- by-country basis, a patent
application or subject matter of a claim thereof pending for more
than five (5) years from the earliest filing date to which such
patent application or claim is entitled shall not be considered to
have any Valid Claim for purposes of this Agreement unless and
until a patent with respect to such application issues with such
claim.

 

“Validive” or
“Validive®” means the Licensed Product
when used in association with the Trademark
“Validive®” or “Clonidine
Lauriad®.”

 

“Validive Materials” means
the Materials further described in SCHEDULE 4.

 

“Year” means a calendar
year.

 

1.2

In
this Agreement:

 

1.2.1

unless the context
requires otherwise, all references to a particular Article, Section
or Schedule shall be references to that article, section or
schedule, of or to this Agreement;

 

1.2.2

the table of
contents and headings are inserted for convenience only and shall
be ignored in construing this Agreement;

 

 

 

 

[***] = Confidential Information has been
omitted and filed separately with the Securities and Exchange
Commission.

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

1.2.3

unless the contrary
intention appears, words importing the masculine gender shall
include the feminine and vice versa and words in the singular
include the plural and vice versa;

 

1.2.4

unless the contrary
intention appears, words denoting persons shall include any
individual, partnership, company, corporation, joint venture,
trust, association, organization or other entity, in each case
whether or not having separate legal personality;

 

1.2.5

reference to any
statute or regulation includes any modification or re-enactment of
that statute or regulation, provided that the modification or
re-enactment does not diminish the rights or extend the obligations
of any Party;

 

1.2.6

references to the
words “include” or “including” shall be
construed without limitation to the generality of the preceding
words;

 

1.2.7

where either
Party’s approval or consent is required hereunder, except as
otherwise specified herein, such Party’s approval or consent
shall be a prior written consent which may be granted or withheld
in such Party’s discretion, but shall not be unreasonably
conditioned, delayed or denied; and

 

1.2.8

all references to
“dollars” shall be to the lawful currency of the United
States of America.

 

 

2.

MONOPAR VALIDIVE OPTION;
MONOPAR DEVELOPMENT AND COMMERCIALIZATION

 

2.1

Monopar Validive Option. Subject to the
terms and conditions of this Agreement, including the payment of
amounts to Onxeo as and when such amounts become due under this
Agreement, Onxeo hereby grants to Monopar the exclusive right,
exercisable at Monopar’s sole discretion, in accordance with
Sections 2.1.1 through 2.1.7, to elect to obtain an exclusive
worldwide license under Section 3.1 to
Develop, Commercialize, and manufacture Licensed Products under the
terms and conditions set forth in this Agreement (the “Monopar Validive
Option”).

 

2.1.1

Monopar Validive Option Period. As from
the Effective Date, Monopar shall:

 

(a)

have [***] to
submit a new application for orphan drug designation in the United
States;

 

 

 

 

[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

(b)

from the time
of receiving feedback from the orphan drug office of the FDA, have
[***] to prepare the materials for and request a meeting with the
FDA;

 

(c)

from the date
of the FDA meeting, have [***] to exercise the Monopar Validive
Option.

 

The
periods described in Sections 2.1.1(a), 2.1.1(b), and 2.1.1(c) shall together be known as the
“Monopar Validive Option
Period”.

 

2.1.2

Monopar Validive Option Termination;
Expiration. The Monopar Validive Option shall terminate or
expire if:

 

(a)

Monopar fails
timely to achieve 2.1.1(a), 2.1.1(b), or 2.1.1(c) without first
having exercised the Monopar Validive Option, and with Onxeo having
promptly responded to information requests during the Monopar
Validive Option Period (any such period of delay by Onxeo shall
cause an automatic equivalent time period extension to the Monopar
Validive Option Period); or

 

(b)

Monopar voluntarily
terminates the Monopar Validive Option at any time and for any
reason;

 

If one
of 2.1.1(a), 2.1.1(b), or 2.1.1(c) is not satisfied, or if Monopar
voluntarily terminates the Monopar Validive Option at any time and
for any reason:

 

(c)

the Monopar
Validive Option shall terminate, and all rights to the Licensed
Product shall remain with Onxeo unencumbered by Monopar’s
option; and

 

(d)

Onxeo shall have
the right to request from Monopar a copy of all documents and
correspondence exchanged with the FDA, at no cost. Such documents
shall be delivered within thirty (30) days of such
request.

 

2.1.3

Monopar Validive Option Exercise. The
Monopar Validive Option shall only be exercisable during the
Monopar Validive Option Period. Monopar shall exercise its Monopar
Validive Option, if at all, by written notice to Onxeo, which
notice shall make reference to this Agreement and
Validive.

 

2.1.4

Monopar Rights on Exercise of the Monopar
Validive Option. Following exercise of the Monopar Validive
Option, Monopar shall have responsibility for Development and
Commercialization of Licensed Products, subject to its obligations
under this Agreement. Upon Monopar’s exercise of the Monopar
Validive Option, Onxeo shall provide Monopar with all information
and data for Licensed Products and the Validive Materials, and
Onxeo shall cooperate with Monopar to provide a smooth transfer of
such information and data and the Validive Materials as soon as
reasonably practical after exercise of the Monopar Validive
Option.

 

 

 

 

2.1.5

Early Exercise of Monopar Validive
Option. Monopar may exercise the Monopar Validive Option at
any time during the Monopar Validive Option Period upon written
notice to Onxeo.

 

2.1.6

Onxeo’s obligations during the Monopar
Validive Option Period. Onxeo shall authorize Monopar to
reference Onxeo’s Validive IND as filed with the FDA, to
submit a new orphan designation dossier for Validive, and to
organize a meeting with the FDA regarding Validive, all in
Monopar’s Name. Onxeo shall provide Monopar with all
authorizations, consents and rights of reference that Monopar may
reasonably request in order to (a) facilitate the submission of the
new orphan designation dossier for Validive, and (b) request for
and conduct a meeting with the FDA regarding Validive in
Monopar’s name. Onxeo shall provide reasonable support to
Monopar in connection with the meeting with the FDA, without
(except as the Parties may otherwise agree) any obligation for
Onxeo to incur any expenses. Onxeo shall not initiate any further
Development efforts during this Monopar Validive Option
Period.

 

2.1.7

Monopar’s obligations during the Monopar
Validive Option Period. Monopar shall, at its own cost and
expense, re-file for orphan drug designation for Validive, and
prepare all required materials, request and lead a meeting with the
FDA regarding development of Validive in the Field and Territory as
specifically related to the treatment of oral mucositis. Without
Onxeo’s permission, or unless required by applicable law,
rules or regulations or request from a stock exchange on which
shares are listed, Monopar shall make no public statement
mentioning Onxeo and/or Validive until the results of the FDA
meeting are known.

 

2.1.8

Monopar’s Failure to Exercise the Monopar
Validive Option. If Monopar does not exercise the Monopar
Validive Option during the Monopar Validive Option Period, then the
Monopar Validive Option shall expire. All rights granted to Monopar
hereunder shall terminate, and Onxeo will thereafter have all such
rights previously granted to Monopar, for Onxeo to Develop and
Commercialize Validive at Onxeo’s sole expense.
Monopar’s rights and licenses granted hereunder to Validive
shall terminate.

 

 

 

 

2.2

Monopar
Development and Regulatory Responsibilities.

 

2.2.1

Development Responsibilities and Costs.
Monopar, at its sole cost and expense, shall have responsibility
for conducting, and shall use Commercially Reasonable Efforts to
conduct, all Development activities with respect to Licensed
Products following exercise of the Monopar Validive
Option.

 

2.2.2

Regulatory Responsibilities and Costs.
Promptly after Monopar’s exercise of the Monopar Validive
Option, Onxeo shall (a) assign to Monopar all Regulatory Filings
for Licensed Products and, (b) upon Monopar’s request, assign
to Monopar all clinical trial or other subcontractor agreements
relating solely to Licensed Products. Following exercise of the
Monopar Validive Option, Monopar shall prepare, file, maintain, and
own all Regulatory Filings and related submissions relating to
Licensed Products. Monopar shall have responsibility for, and shall
prepare, all Regulatory Filings and related submissions with
respect to Licensed Products. At Monopar’s election,
following exercise of the Monopar Validive Option, Monopar shall be
responsible for all safety reporting obligations globally with
respect to such Licensed Products, and to take over and maintain
the global safety database for Licensed Products.

 

2.2.3

Record Keeping; Audit for Cause. Each
Party shall maintain, or cause to be maintained, records of its
respective Development and regulatory activities with respect to
the Licensed Product in the Field in the Territory in sufficient
detail and in good scientific manner appropriate for patent and
regulatory purposes, which shall be complete and accurate and shall
fully and properly reflect all work done and results achieved in
the performance of its respective development activities, and which
shall be retained by such Party for at least ten (10) years after
the termination of this Agreement, or for such longer period as may
be required by applicable law. Each Party shall have the right,
during normal business hours, upon at least ten (10) Business Days
prior notice and without charge, to inspect and copy any such
records, except in the event of an audit for safety reason;
provided, however, that, except in the event of an “audit for
cause,” neither Party shall have the right to conduct more
than one such inspection in any twelve (12) month period.
“Audit for
cause” shall mean any audit conducted by Onxeo in
reason of any material deficiencies of Monopar or its Affiliates or
Sublicensees relating to the activities contemplated
hereunder. 

 

 

 

 

2.3

Monopar Commercialization Responsibilities and
Costs. Monopar, at its sole cost and expense, shall have
responsibility for conducting, and shall use Commercially
Reasonable Efforts to conduct, all Commercialization activities
with respect to Licensed Products following exercise of the Monopar
Validive Option.

 

2.4

Manufacture and Supply. Monopar, at its
sole option and expense, may choose to continue with Onxeo’s
current contract manufacturing partners for part or all presently
sourced manufacturing or manufacturing related activities,
including API and Licensed Product manufacture, for part or all of
the Term. In such event, Monopar shall be solely responsible for
negotiating agreements with such manufacturing partners, it being
understood and agreed that Onxeo’s sole obligation in this
respect shall be to introduce Monopar to such manufacturing
partners. Under all circumstances, Monopar reserves the exclusive
right to manufacture and supply any and all Licensed
Products.

 

2.5

Reporting
and Right of Inspection.

 

2.5.1

Monopar shall
provide Onxeo upon Monopar’s exercise of the Monopar Validive
Option with a copy of an initial Development and Commercialization
plan for the Licensed Products. Thereafter, Monopar shall provide
Onxeo with an updated Development and Commercialization plan for
each Year no later than December 1 of the Year for each Year.
Additionally, every Year within thirty (30) days after
Monopar’s annual financial reports have been completed,
but in no event later than April 1, the Parties shall
meet by teleconference to discuss the progress in and results of
the Development and Commercialization of the Licensed Products
during the previous year.

 

2.5.2

During the Term,
Monopar shall also keep (and shall cause its Affiliates and
Sublicensees to keep), and shall make available to Onxeo for
inspection on Onxeo’s reasonable demand once per year
complete and accurate records pertaining to the progress in and
results of the Development and Commercialization activities in the
Territory, in sufficient detail to permit Onxeo to ensure the
satisfaction of Monopar’s contractual obligations
hereunder.

 

 

 

 

2.6

Subcontracting

 

Monopar
may have performed by subcontractors any activities required of
Monopar hereunder. Monopar shall be solely responsible for the
performance by any of its subcontractors of Monopar’s
obligations hereunder.

 

2.7

No
Onxeo Financial Obligation

 

Except
as expressly provided herein, all costs relating to the Development
and Commercialization of the Licensed Product after Monopar’s
exercise of the Monopar Validive Option shall be borne solely by
Monopar, and Onxeo shall not be obligated to take any action which
may subject Onxeo to any cost, expense or liability with respect to
other matters.

 

 

3.

LICENSES; TECHNOLOGY TRANSFER;
EXCLUSIVITY

 

3.1

License to Monopar for Validive
and Licensed Products.

 

3.1.1

Licensed Intellectual Property. Subject
to the terms and conditions of this Agreement, Onxeo hereby grants
to Monopar and its Affiliates the exclusive (even as to Onxeo and
its Affiliates), worldwide license, with the right to grant
sublicenses under the Licensed Intellectual Property as described
in Section 3.2 below, to use,
sell, offer to sell, import, make and have made, and otherwise
Develop, Commercialize or manufacture Licensed Products during the
Term, in the Territory and in the Field, and to apply for
Regulatory Approval in its own name for Licensed Products in any
jurisdiction, such license to be effective upon Monopar’s
exercise of the Monopar Validive Option and payment of the License
Fee.

 

3.1.2

License to Trademark. Subject to the
terms and conditions of this Agreement, and at no additional cost
to Monopar or its Affiliates, Onxeo hereby grants to Monopar and
its Affiliates an exclusive right and license during the Term, with
the right to grant sublicenses as described in Section 3.2 below, to the Licensed Trademarks, such
Licensed Trademarks to be used by Monopar solely in connection with
the Development and Commercialization of Licensed Products and in
Monopar’s corporate communications with respect thereto. A
complete list of such Licensed Trademarks, and existing
registrations thereof, is attached as SCHEDULE 3. Monopar shall be in charge of
securing and maintaining the registration(s) of the Licensed
Trademarks in the Territory in the name of Monopar and at its sole
cost and expense. Onxeo shall provide upon request, and at no cost
to Onxeo, any assistance reasonably required by
Monopar.

 

 

 

 

3.2

Sublicenses. Monopar shall have the
right to grant sublicenses to Third Parties without the prior
written consent of Onxeo. Monopar shall ensure that there are
included in the terms of any sublicense substantially equivalent
obligations and undertakings on the part of the Sublicensee to
those applying to Monopar in this Agreement. Any such sublicenses
shall be without limitation on Monopar’s obligations
hereunder and Monopar shall be solely responsible for the
performance by any of its Sub-Licenses of Monopar’s
obligations hereunder.

 

3.3

Use of Names; Logo. Monopar, at its sole
cost and expense, shall be responsible for the selection,
registration, and maintenance of all Trademarks which it employs in
connection with its activities conducted pursuant to this
Agreement, including those licensed hereunder.

 

3.4

No other licenses. No license to use any
Intellectual Property is granted to Monopar, or any Sublicensee,
except the rights expressly granted in this Agreement.

 

3.5

Technology Transfer by Onxeo after Exercise by
Monopar of the Monopar Validive Option. As soon as
reasonably practical after Monopar exercises its Monopar Validive
Option, Onxeo shall transfer to Monopar, at no cost to Monopar, all
Onxeo Licensed Know-How and other information in Onxeo’s
possession and Control or reasonably available to Onxeo that are
necessary or useful for the exercise by Monopar and its Affiliates
of the rights granted under Section 3.1 with respect to Licensed
Products and the Validive Materials. Onxeo shall provide all
reasonable assistance, including making its personnel reasonably
available for meetings or teleconferences, to support and assist
Monopar, at no cost to Onxeo, in the Development and
Commercialization of Licensed Products, for a period of one (1)
year after Monopar exercises its Monopar Validive Option. Within
thirty (30) days of receiving the License Fee, Onxeo
shall:

 

3.5.1

transfer title to
all IND’s for Licensed Products to Monopar;

 

3.5.2

assign Licensed
Patents to Monopar;

 

3.5.3

assign Licensed
Trademarks to Monopar;

 

3.5.4

submit to the
appropriate authorities the necessary paperwork to transfer title
to all orphan drug designations for Licensed Products to
Monopar;

 

3.5.5

transfer title in
the Validive Materials to Monopar. Such materials are purchased
‘as is’ and “where is” and it shall be
Monopar’s responsibility to check the quality of such
materials and that they are suitable for Monopar’s use
thereof; and

 

 

 

 

[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

3.5.6

provide Monopar
with such information and Know-How relating to the manufacture of
Validive as is relevant to the efficient production of a sufficient
quantity of Validive for clinical trials.

 

3.6

Exclusivity. During the Term, Onxeo will
not engage in the research, discovery, optimization, development or
commercialization of any products that would be considered a
Licensed Product. Notwithstanding the foregoing, following
termination of this Agreement, Onxeo shall be free to research,
optimize, develop or commercialize, either on its own or with or
through a Third Party, any Licensed Product.

 

3.7

Acquisition of Rights.
Should Monopar wish, at
any time during the Term, to acquire all right, title, and interest
in and to the Licensed Intellectual Property, then held by Onxeo or
any successor or permitted assignee, it may by giving notice to
Onxeo request that Onxeo enter into negotiations in this regard.
Any such acquisition on terms and conditions (including financial
terms and conditions) acceptable to each Party in its sole
discretion.

 

4.

FINANCIAL TERMS

 

4.1

Option Fee. [***] for entering into this
Agreement.

 

4.2

License Fee.

 

4.2.1

Monopar shall pay
to Onxeo within ten (10) Business Days of exercising the Monopar
Validive Option the sum of one million dollars ($1,000,000.00), the
“License Fee”.
The License Fee is a one-time, non-refundable, non-creditable
payment.

 

4.3

Development and Sales
Milestones.

 

4.3.1

Monopar shall
pay the following payments (each, a “Milestone Payment”) to Onxeo upon
the first occurrence only of the following events (each, a
“Milestone
Event”) in relation to Licensed Product:

 

(a)

[***] upon [***]
for a Licensed Product;

 

 

 

 

[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

(b)

t[***] upon [***]
for a Licensed Product;

 

(c)

[***] upon [***]
for a Licensed Product;

 

(d)

[***] upon [***]
for a Licensed Product;

 

(e)

[***] upon
[***];

 

(f)

[***] upon
[***];

 

(g)

[***] upon
[***];

 

(h)

[***] upon
[***];

 

(i)

[***] upon [***];
and

 

(j)

[***] upon
[***].

 

4.4

Royalty. Monopar shall pay royalties to
Onxeo on a Licensed Product-by-Licensed Product and
country-by-country basis until the later of (1) the date when the
Licensed Product is no longer within the scope of a Valid Claim of
a Licensed Patent in the country of sale or manufacture, (2) the
expiry of any Extended Exclusivity Period in the relevant country,
or [***] after the First Commercial Sale of the Licensed Product in
such country. The rate shall be [***] of Net Sales ex-US. For the
United States, the rate shall be [***] of Net Sales for the [***]
starting from the First Commercial Sale of Licensed Product [***]
of Net Sales for [***] after the First Commercial Sale of Licensed
Product, and [***] of Net Sales from [***] onward after the First
Commercial Sale of Licensed Product. The otherwise applicable rate
shall be reduced by [***] on a Licensed Product-by-Licensed Product
and country-by-country basis if a royalty payment is due solely by
reason of subparagraph (3) above.

 

 

 

 

4.5

Payments. All payments due to Onxeo
under this Agreement shall be made in dollars by bank wire transfer
of immediately available funds, with fees of the transmitting bank
paid by Monopar, to such bank account as Onxeo may notify to
Monopar in writing from time to time.

 

4.6

Timings of Payments.

 

4.6.1

The payments due
under Section 4.3 shall be payable
within sixty (60) Business Days after when they are
due.

 

4.6.2

Any royalties due
pursuant to Section 4.4 shall be paid
Quarterly within sixty (60) days of the end of each Quarter with
respect to Net Sales in such Quarter; and

 

4.6.3

After Monopar
exercises the Monopar Validive Option, any costs or expenses
related to the Prosecution, registration or maintenance of Licensed
Patents or Licensed Trademarks shall be paid by
Monopar.

 

4.7

Taxes. All payments to Onxeo under this
Agreement are expressed to be inclusive of value added tax (or any
other sale goods tax) howsoever arising.

 

4.8

Withholding. In the event that Monopar
is required by law to withhold or pay to any government authority
any taxes on behalf of Onxeo, with respect to any payments to it
hereunder, the amount payable to Onxeo shall not be increased such
that the amount that Onxeo actually receives is equal to the amount
that Onxeo would have received had no withholding been made.
Monopar shall furnish Onxeo with proper evidence of the taxes so
paid and Onxeo shall be responsible for reclaiming such tax. Each
Party shall furnish the other Party with appropriate documents to
secure application of the most favorable rate of withholding tax
under applicable Law. Notwithstanding the above, in the event that
Monopar, by reason of an assignment of its rights hereunder or
other actions, causes Onxeo to be subject to withholding to which
Onxeo is not subject as of the Effective Date, if Onxeo is unable
to reclaim such withholding tax payments, Monopar shall increase
such payments made hereunder such that the amount that Onxeo
actually receives is equal to the amount that Onxeo would have
received had no withholding been made.

 

 

 

 

4.9

Quarterly Report. Within forty-five (45)
days after the end of each Quarter, Monopar shall send to Onxeo a
written statement detailing in respect of that Quarter (including a
nil report if appropriate):

 

4.9.1

any Milestone Event
achieved by it or any Sublicensee and any Milestone Payment which
became due to Onxeo;

 

4.9.2

the quantity of
Licensed Products sold or otherwise disposed of by Monopar at the
wholesale and retail levels, its Affiliates or any Sublicensees in
the Territory;

 

4.9.3

the Net Sales in
respect of Licensed Products in each country of the Territory in
sufficient detail to allow Onxeo to calculate all payments due
under Section 4.3 and Section 4.4, including, without limitation, the
numbers of units of Licensed Products sold, the aggregate gross
sales price for such units (in its native currency), and a
description of the amount and justification for an any deductions
made to such aggregate gross sales in determining the reported Net
Sales;

 

4.9.4

the aggregate Net
Sales in respect of that Quarter for Licensed Product;

 

4.9.5

any currency
conversions, showing the rates used; and

 

4.9.6

the amount of the
royalties due to Onxeo in respect of that Quarter.

 

4.10

Interest. Where the payee does not
receive payment within the relevant period of any sums that are
finally determined to be due and payable to it under this
Agreement, interest shall accrue on the sum due and payable from
the date payment was first due to the date payment is made at the
rate equivalent to an annual rate of two percent (2%) over the then
current base rate of one (1) month LIBOR, calculated on a daily
basis, without prejudice to payee’s right to receive payment
within the relevant period, provided always the provisions of this
Section 4.10 shall not apply to the
extent and for the period that a Force Majeure event prevents
payment.

 

4.11

Accounts.

 

4.11.1

Monopar
shall:

 

(a)

keep and,
notwithstanding the expiry or termination of this Agreement,
maintain for at least six (6) years, true and accurate accounts and
records (including any underlying documents supporting such
accounts and records) in sufficient detail to enable the amount of
all sums payable under this Agreement to be determined;
and

 

 

 

 

[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

(b)

during the Term
and thereafter until the said period of six (6) years relevant to
the accounts and records has expired, at the reasonable request of
Onxeo and (subject to Section 4.11.2)
at the expense of Onxeo from time to time, permit or procure
permission for a qualified accountant nominated by Onxeo and
reasonably acceptable to Monopar to inspect and audit those
accounts and records.

 

4.11.2

If, following
any inspection pursuant to Section 4.11.1(b), Onxeo's nominated accountant
confirms to Onxeo that the payments in respect of any Year fall
short of the sums which were properly payable in respect of that
Year under this Agreement, Onxeo shall send a copy of the
certificate to Monopar and Monopar shall (subject to Section
4.11.3) within [***] of the date of
receipt of the certificate pay the shortfall to Onxeo and, if the
shortfall exceeds the greater of [***] of the sum properly payable
or [***], Monopar shall also reimburse to Onxeo the reasonable
costs and expenses of Onxeo in making the inspection, provided that
costs and expenses so reimbursed shall not exceed [***] of the
shortfall so determined.

 

4.11.3

If within
thirty (30) days of the date of receipt by Monopar of any
certificate produced pursuant to Section 4.11.2 Monopar notifies Onxeo in writing that
it disputes the certificate, the dispute shall be referred for
resolution by an independent expert jointly appointed by the
Parties. If the Parties fail to jointly appoint an independent
expert, shall be finally resolved as provided in Article 10 (Dispute Resolution).

 

 

5.

INTELLECTUAL
PROPERTY

 

5.1

Ownership of Arising Intellectual
Property. All right, title and interest in and to any data,
Patents, and extensions thereof, Know-How and other information
created, developed, or arising on or after the Effective Date and
pertaining to Licensed Products shall be solely owned by Monopar.
For the avoidance of doubt, Arising Intellectual Property generated
through CMC, Quality, data, or clinical observations will be owned
by Monopar. As of the Effective Date, at its own cost, Monopar
shall have the full and exclusive benefit of, and right to apply
for and obtain, patents or other similar forms of protection in
respect of any part or parts of the subject-matter of the Licensed
Patents throughout the world, and the right to claim priority from
the Licensed Patents.

 

5.2

Ownership of Clinical Data. Any Clinical
Data generated by or on behalf of Monopar will be owned by
Monopar.

 

 

 

 

[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

5.3

Intellectual Property
Management.

 

5.3.1

Upon Monopar
exercising its Monopar Validive Option, Monopar shall be
responsible for, and shall bear or pay all costs and expenses
related to, the Prosecution and maintenance, of the Licensed
Patents and Patents claiming any Arising Intellectual Property, and
the registration, renewal and maintenance of the Licensed
Trademarks, until the termination of this agreement. The Parties
shall hold all information they know or acquire under this Section
5.3.1 that is related to all such
Patents as confidential, subject to the provisions of this
Agreement.

 

5.3.2

Monopar shall keep
Onxeo reasonably informed in writing as to the Prosecution,
registration and/or maintenance status of the Licensed Patents and
Licensed Trademarks, and shall at Onxeo's request promptly provide
Onxeo with a copy of all submissions made to or responses received
from the relevant patent and trademark offices and all
correspondence to and responses received from the relevant patent
and trademark agents in relation to the Licensed Patents and
Licensed Trademarks in each country of the Territory.

 

5.3.3

If Monopar elects
not to file an application or otherwise not prosecute, register
and/or maintain a Licensed Patent or Licensed Trademark in any
country of the Territory, Monopar shall notify Onxeo in writing
promptly of its decision and shall use its reasonable efforts to
provide Onxeo with at least [***] notice prior to the expiration of
any applicable time bars. During the aforementioned [***] notice
period, Monopar shall retain the responsibility for the
Prosecution, registration and maintenance of the relevant Licensed
Patent or Licensed Trademark. On the expiry of such notice
period:

 

(a)

the license granted
pursuant to Section 3.1.1 shall
terminate in respect of that country and that relevant Licensed
Product for any relevant Licensed Patent or Licensed Trademark
which is the subject of such a notice;

 

(b)

Monopar shall, at
Onxeo's request, promptly transfer to Onxeo (or any person
nominated by Onxeo) any and all documents and information in
Monopar's control relating to such relevant Licensed Patent or
Licensed Trademark; and

 

(c)

Onxeo shall be free
to Prosecute, register or abandon such relevant Licensed Patent or
Licensed Trademark at its sole discretion and to grant rights
thereunder to any Person without further reference to Monopar, and
Onxeo shall thereafter be responsible for the expense of filing,
prosecuting, registering and maintaining the relevant Patents and
Trademarks.

 

 

 

[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

5.3.4

Infringement. Each Party will promptly
notify the other Party in writing within [***] of it becoming aware
of any infringement or suspected infringement by a Third Party of
any of the Licensed Patents or Licensed Trademarks, or any
unauthorized use of the Licensed Know-How. In respect of the
Licensed Patents, Patents claiming Arising Intellectual Property or
Licensed Trademarks, Monopar may (a) at its own cost and expense
and subject to Section 5.3.5, bring
proceedings in its own name or, if required by law, jointly with
Onxeo, for infringement of the Licensed Patents, Patents claiming
Arising Intellectual Property or Licensed Trademarks; and (b) in
any such proceedings settle any claim for infringement of the
Licensed Patents, Patents claiming Arising Intellectual Property or
Licensed Trademarks, provided that Monopar shall not, without the
consent of Onxeo (which consent shall not be unreasonably withheld,
conditioned or delayed), enter into any settlement that (a) imposes
any liability or obligation on Onxeo, or (b) unreasonably reduces
(i) the scope of the subject matter claimed in any Licensed Patent
or (ii) the right to use any Licensed Trademark. Should Monopar
fail to initiate such infringement proceedings within ten (10)
Business Days of a demand therefor from Onxeo, Onxeo may do so at
its own cost and subject to Section 5.3.5.

 

Monopar
shall be solely responsible for the defense of any claims that its
activities with respect to Licensed Products infringe the
Intellectual Property Rights of any Third Parties and shall bear
and pay the costs and expenses thereof.

 

5.3.5

Entitlement to Proceeds. Any damages,
profits and awards of whatever nature recovered by a Party in any
proceedings referred to in this Section 5.3 shall be retained solely by the Party
directing or defending such suit or proceeding. In any such
proceedings, the Party bringing or defending the proceedings (the
“Active Party”)
and the other Party (the “Inactive Party”) will bear all of
its own costs, including attorneys’ fees, relating to such
legal proceedings; provided that the Active Party shall bear the
Inactive Party’s out-of-pocket expenses, including
attorneys’ fees, incurred in complying with requests for
cooperation made by the Active Party. The Inactive Party shall
promptly provide the Active Party with all documents and assistance
as the Active Party may reasonably require. The Active Party shall
promptly provide the Inactive Party with notice of such proceedings
and keep the Inactive Party regularly informed of progress and
promptly provide the Inactive Party with such information as the
Inactive Party may reasonably require including copies of all
documents filed at court in the proceedings.

 

 

 

 

5.3.6

Confirmatory Patent Licenses. The
Parties shall, at the request of either of them and at the expense
of the requesting Party but for no further consideration, enter
into such confirmatory patent licenses relating to the Licensed
Patents, substantially in the form set out in SCHEDULE 5, as may be necessary or desirable
in accordance with the relevant Law and practice in each country in
the Territory for registration at the relevant patent offices so
that this Agreement need not be registered or recorded unless the
Parties are required to do so by law. If there are any
inconsistencies between the terms of any such confirmatory patent
license and the provisions of this Agreement, this Agreement shall
prevail.

 

5.3.7

Patent Term Extension. With respect to
Licensed Products, Onxeo grants Monopar the exclusive right to
apply for, in its own name where possible, a Supplementary
Protection Certificate, patent term extension and/or any other
exclusivity in respect of any Licensed Product. At Monopar's
reasonable request, Onxeo shall provide, at no cost to itself,
reasonable assistance to Monopar in connection with any such
applications.

 

6.

WARRANTIES AND LIMITATION OF
LIABILITY

 

6.1

Warranty.

 

6.1.1

No reliance on warranties not in the
Agreement. Each Party acknowledges that, in entering into
this Agreement, it does not do so in reliance on any warranty or
other provision except as expressly provided in this Agreement, and
all conditions, warranties, terms and undertakings implied by
statute or otherwise are excluded from this Agreement to the
fullest extent permissible by law.

 

6.1.2

Warranties. Each Party hereby warrants
to the other Party that, as of the Effective Date:

 

(a)

it is duly
organized and validly existing under the laws of its place of
incorporation;

 

 

 

 

(b)

it has legal power,
authority and right to enter into this Agreement;

 

(c)

the execution and
performance by it of its obligations hereunder will not constitute
a breach of, or conflict with, its organizational documents nor any
other material agreement or arrangement, whether written or oral,
by which it is bound;

 

(d)

it has full
corporate power and authority and has taken all corporate action
necessary to enter into and perform this Agreement, and that this
Agreement has been duly authorized, executed, and delivered by that
Party; and

 

(e)

that this Agreement
is a valid, binding, and legally enforceable obligation of that
Party (subject to applicable Laws of insolvency and bankruptcy and
customary conditions and limitations as concerns equitable
remedies).

 

6.1.3

Additional Warranties of Onxeo. Onxeo
warrants to Monopar at the Effective Date that:

 

(a)

it does not Control
any Intellectual Property which is required for the use, import,
development or sale of the Licensed Product in the Territory which
is not included in the licenses granted under this
Agreement;

 

(b)

as far as it is
aware there is no pending or existing, nor has Onxeo received
notice of any threatened, litigation, actions, suits or claims
against it before any court or governmental agency or other
tribunal with regard to the Licensed Intellectual
Property;

 

(c)

as far as it is
aware there are no oppositions, inter partes reviews, post grant
reviews, derivation proceedings, or interferences concerning the
Licensed Patents pending before any governmental agency or other
tribunal;

 

(d)

as far as it is
aware there are no inventors of the Licensed Patents other than the
inventors named therein;

 

(e)

it is the legal and
beneficial owner of the Licensed Intellectual Property free of any
third party rights or encumbrances,

 

(f)

as far as it is
aware all maintenance fees and annual payments due in respect of
the Licensed Patents have been paid;

 

 

 

 

(g)

as far as it is
aware the use and possession of Validive or Validive Materials by
Monopar shall not infringe the rights (including without limitation
any Intellectual Property Rights) of any third party;

 

(h)

it has not done
anything whereby the whole or any part of the rights assigned or
licensed under the Agreement might be invalidated or registration
of them refused;

 

(i)

it has not and will
not enter into any agreement which prevents it fulfilling its
obligations under this Agreement; and

 

(j)

as far as it is
aware there is no material Know-How that is necessary or useful to
the Development, Commercialization or manufacturing of the Product
that is not included in the Licensed Know-How.

 

6.1.4

No Further Representations or
Warranties. No director, officer, employee or agent of any
Party or its Affiliates is authorized to make any further
representation or warranty to the other Party which is not
contained in this Agreement, and each Party acknowledges that it
has not relied on any such oral or written representations or
warranties.

 

6.2

Limitation of Liability. Neither Party,
nor any Onxeo Indemnified Party, nor any Monopar Indemnified Party,
nor their respective directors, officers, employees and agents
shall have any liability under or in connection with this Agreement
whether under statute or in tort (including but not limited to
negligence), contract or otherwise in respect of: (i) any
consequential or indirect loss; and/or (ii) any loss of goodwill,
profit, opportunity or contract, in either case even if advised in
advance of the possibility of such losses. However, nothing in this
Agreement shall be construed as excluding or limiting the liability
of any person for any liability which cannot be limited or excluded
by law, such as for personal injury or death. This Section 6.2 in
no way shall be construed to limit the liability of one Party to
the other Party for milestones and royalties payable under the
terms of this Agreement.

 

7.

INDEMNITY AND
INSURANCE

 

7.1

Indemnity.

 

7.1.1

Indemnification by Monopar. Monopar
shall indemnify, defend and hold harmless the Onxeo Indemnified
Parties against any and all Losses incurred or suffered by the
Onxeo Indemnified Parties to the extent any Loss arises out of or
was caused by an act or omission of Monopar arising from or in
connection with: (a) the exercise of the rights granted in Section
3.1 or the actions of Monopar in
relation to its Development, Commercialization or manufacture of a
Licensed Product; or (b) in the performance of its obligations
under this Agreement; except, in all cases, to the extent that such
Loss arises out of or was caused by the violation by Onxeo of a
legal or contractual duty owed to Monopar.

 

 

 

 

[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

7.1.2

Indemnification by Onxeo. Onxeo shall
indemnify, defend and hold harmless the Monopar Indemnified Parties
against any and all Losses incurred or suffered by the Monopar
Indemnified Parties to the extent such Loss arises out of or was
caused by an act or omission of Onxeo in the performance of its
obligations under this Agreement except, in all cases, to the
extent that such Loss arises out of or was caused by the violation
by Monopar of a legal or contractual duty owed to
Onxeo.

 

7.1.3

Notification of Liabilities/Losses. A
person or entity entitled to indemnification under this Section
7.1 (an “Indemnified Party”) shall give
prompt written notification [***] to the Party from whom
indemnification is sought (the “Indemnifying Party”) of the
commencement or notice of any claim or proceeding relating to a
Loss for which indemnification may be sought or, if earlier, upon
the assertion of any such Loss, (it being understood and agreed
that the failure by an Indemnified Party to give notice of a Loss
of which it has knowledge as provided in this Section 7.1.3 within [***] shall relieve the
Indemnifying Party of its indemnification obligation under this
Agreement). The Indemnifying Party shall be liable for any
reasonable legal fees and expenses subsequently incurred in
connection with the defense of such Loss after receiving such
notice. The Parties shall thereafter keep the other Party informed
of any Losses.

 

(a)

In the case of
a Loss for which Onxeo seeks indemnification under Section 7.1.1, Onxeo shall permit Monopar to direct
and control the defense of the Loss and shall provide such
reasonable assistance as is reasonably requested by Monopar (at
Monopar’s cost) in the defense of the Loss; provided that
nothing in this Section 7.1.3(a) shall
permit Monopar to make any admission on behalf of Onxeo, or to
settle any claim or litigation which would impose any financial
obligations on Onxeo without the prior written consent of Onxeo,
such consent not to be unreasonably conditioned, withheld, or
delayed.

 

 

 

 

(b)

In the case of
a Loss for which Monopar seeks indemnification under Section
7.1.2, Monopar shall permit Onxeo to
direct and control the defense of the Loss and shall provide such
reasonable assistance as is reasonably requested by Onxeo (at
Onxeo’s cost) in the defense of the Loss, provided always
that nothing in this Section 7.1.3(b)
shall permit Onxeo to make any admission on behalf of Monopar, to
settle any claim or litigation which would impose any financial
obligations on Monopar without the prior written consent of
Monopar, such consent not to be unreasonably conditioned, withheld
or delayed.

 

7.2

Insurance. Each Party, at its own
expense, and reasonably prior to Commencement of any human being
dosed with the Licensed Product, shall put in place and thereafter
maintain, at its own cost, insurance through a reputable insurance
company. For clarification, such insurance shall be maintained for
an amount within the range that is customary for similar products
in the Territory, on a country-by-country basis, where they are
sold.

 

 

8.

CONFIDENTIALITY

 

8.1

Nondisclosure. Each Party agrees that,
during the Term and for a period of seven (7) years thereafter, a
Party (the “Receiving
Party”) receiving Confidential Information of the
other Party (the “Disclosing
Party”) (or that has received any such Confidential
Information from the other Party prior to the Effective Date) shall
(a) maintain in confidence such Confidential Information using not
less than the efforts such Receiving Party uses to maintain in
confidence its own proprietary industrial information of similar
kind and value, (b) not disclose such Confidential Information to
any Third Party without the prior written consent of the Disclosing
Party, except for disclosures expressly permitted below, and (c)
not use such Confidential Information for any purpose except those
permitted by this Agreement (it being understood that this clause
(c) shall not create or imply any rights or licenses not expressly
granted under this Agreement).

 

8.2

Exceptions. The obligations in Section
8.1 shall not apply with respect to
any portion of the Confidential Information that the Receiving
Party can show by competent written proof:

 

8.2.1

is publicly
disclosed by the Disclosing Party, either before or after it is
disclosed to the Receiving Party hereunder;

 

 

 

 

8.2.2

was known to the
Receiving Party or any of its Affiliates, without any obligation to
keep it confidential or any restriction on its use, prior to
disclosure by the Disclosing Party;

 

8.2.3

is subsequently
disclosed to the Receiving Party or any of its Affiliates by a
Third Party lawfully in possession thereof and without any
obligation to keep it confidential or any restriction on its
use;

 

8.2.4

is published by a
Third Party or otherwise becomes publicly available or enters the
public domain, either before or after it is disclosed to the
Receiving Party; or

 

8.2.5

is independently
developed by or for the Receiving Party or its Affiliates without
reference to or reliance upon the Disclosing Party’s
Confidential Information.

 

8.3

Authorized Disclosure. The Receiving
Party may disclose Confidential Information belonging to the
Disclosing Party, and Confidential Information deemed to belong to
both Parties under the terms of this Agreement, to the extent (and
only to the extent) such disclosure is reasonably necessary in the
following instances:

 

(a)

Prosecuting
Patents;

 

(b)

Regulatory Filings
and obtaining Regulatory Approvals;

 

(c)

Prosecuting or
defending litigation, including responding to a subpoena in a third
party litigation;

 

(d)

Subject to Section
8.4, complying with Laws (including
the rules and regulations of the Securities and Exchange Commission
or any securities exchange) and with judicial process, if in the
reasonable opinion of the Receiving Party’s counsel, such
disclosure is necessary for such compliance; and

 

(e)

Disclosure, solely
on a “need to know basis,” to Affiliates.

 

8.4

Securities Filings. In the event either
Party proposes to file with the Securities and Exchange Commission
or the securities regulators of any state or other jurisdiction a
registration statement or any other disclosure document which
describes or refers to the terms and conditions of this Agreement
under the Securities Act of 1933, as amended, the Securities
Exchange Act of 1934, as amended, or any other applicable
securities Law, the Party shall notify the other Party of such
intention and shall provide such other Party with a copy of
relevant portions of the proposed filing prior to such filing (and
any revisions to such portions of the proposed filing a reasonable
time prior to the filing thereof), including any exhibits thereto
relating to the terms and conditions of this Agreement, and shall
use reasonable and diligent efforts to obtain confidential
treatment of the terms and conditions of this Agreement that such
other Party requests be kept confidential, and shall only disclose
Confidential Information that it is advised by counsel that it
legally is required to disclose. No such notice shall be required
under this Section 8.4 if the
description of or reference to this Agreement contained in the
proposed filing has been included in any previous filing made by
either Party hereunder or otherwise approved by the other
Party.

 

 

 

 

8.5

Publications. After exercise of the
Monopar Validive Option, Monopar shall have the exclusive right to
publish or present data and/or results relating to Licensed
Products.

 

8.6

Effect of Disclosure. The Receiving
Party agrees that the disclosure of the Disclosing Party's
Confidential Information without the express written consent of the
Disclosing Party may cause irreparable harm to the Disclosing
Party, and that any breach or threatened breach of this Agreement
by the Receiving Party may entitle the Disclosing Party to
injunctive relief, in addition to any other legal remedies
available to it, in any court of competent
jurisdiction.

 

8.7

Relationship to Confidentiality
Agreement. This Agreement supersedes the Mutual Confidential
Disclosure Agreement between the Parties executed as of January 19,
2016; provided that all “Confidential Information”
disclosed or received by the Parties thereunder shall be deemed
“Confidential Information” hereunder and shall be
subject to the terms and conditions of this Agreement.

 

9.

TERM AND
TERMINATION

 

9.1

Term; Expiration. This Agreement shall
become effective as of the Effective Date and shall continue in
force and effect until expiration as described in this
Section 9.1, unless earlier
terminated pursuant to Section 9.2,
9.3, or 9.4, and shall expire as follows:

 

9.1.1

on a Licensed
Product-by-Licensed Product and country-by-country basis, on the
date of expiration of all payment obligations of Monopar under this
Agreement with respect to each Licensed Product in each country, as
applicable;

 

9.1.2

in its entirety
upon the expiration of all payment obligations under this Agreement
with respect to the last Licensed Product Commercialized in the
last country in the Territory; or

 

 

 

 

[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

9.1.3

if Monopar does
not exercise the Monopar Validive Option in accordance with Section
2.1, then this Agreement will
terminate in its entirety upon the expiration of the Monopar
Validive Option.

 

9.1.4

The period
beginning on the Effective Date and ending on expiration or
termination of this Agreement, or as the case may be, until the
date of expiration or termination of a Licensed Product, shall be
the “Term” of
this Agreement in its entirety or with respect to a given Licensed
Product, as applicable.

 

9.2

Termination for
cause.

 

9.2.1

Material Breach. Either Party (the
“Non-Breaching
Party”) may, without prejudice to any other remedies
available to it at law or in equity, terminate this Agreement in
its entirety, or terminate any Licensed Product in any portion of
the Territory that is affected by a material breach, in its sole
discretion, in the event the other Party (the “Breaching Party”) has materially
breached this Agreement, and such breach, if curable, has continued
for [***] (the “Cure
Period”) after written notice thereof is provided to
the Breaching Party by the Non-Breaching Party, such notice
describing the alleged material breach in sufficient detail to put
the Breaching Party on notice; provided that, if such breach is not
susceptible to cure within the Cure Period, then, the Non-Breaching
Party’s right to termination shall be suspended only if and
for so long as the Breaching Party has provided to the
Non-Breaching Party a written plan that is reasonably calculated to
effect a cure and such plan is reasonably acceptable to the
Non-Breaching Party, and the Breaching Party commits to and does
carry out such plan. In all circumstances, if within the Cure
Period the Breaching Party pays the Non-Breaching Party an amount
equal to the costs, damages, expenses and losses incurred as a
result of the material breach, the material breach shall be
considered cured.

 

9.2.2

Disagreement as to Material Breach; Cure
Period. If the Parties reasonably and in good faith disagree
as to whether there has been a material breach, the Party that
disputes that there has been a material breach may contest the
allegation in accordance with Article 10 (Dispute Resolution). Notwithstanding the
preceding sentence, the Cure Period for any allegation made in good
faith as to a material breach under this Agreement will run from
the date that written notice thereof was first provided to the
Breaching Party by the Non-Breaching Party. The right of either
Party to terminate this Agreement, in whole or in part, as provided
in this Section 9.2, shall not be
affected in any way by such Party’s waiver or failure to take
action with respect to any previous default. It is understood and
acknowledged that, during the pendency of such a dispute, all of
the terms and conditions of this Agreement shall remain in effect,
and the Parties shall continue to perform all of their respective
obligations under this Agreement.

 

 

 

 

[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

9.3

Monopar Unilateral Termination
Rights.

 

9.3.1

Termination of Agreement in Its
Entirety. Monopar may, in its sole discretion, exercisable
at any time during the Term, terminate this Agreement in its
entirety for any reason or no reason at all, upon [***] written
notice to Onxeo.

 

9.3.2

Termination on a Licensed Product-by-Licensed
Product basis. Monopar may, in its sole discretion,
exercisable at any time during the Term, terminate this Agreement
on a Licensed Product-by-Licensed Product basis for any reason or
no reason at all, upon [***] written notice to Onxeo.

 

9.4

Termination for Insolvency. To the
extent permitted under Law, either Party may terminate this
Agreement, (a) if, at any time, the other Party files in any court
or agency pursuant to any statute or regulation of any state or
country, a petition in bankruptcy or insolvency or for
reorganization or for an arrangement or for the appointment of a
receiver or trustee of the Party or of substantially all of its
assets, or (b) if the other Party is served with an involuntary
petition against it, filed in any insolvency proceeding, and such
petition shall not be dismissed within [***] after the filing
thereof, or (c) if the other Party shall propose or be a party to
any dissolution or liquidation, or (d) if the other Party shall
make an assignment of substantially all of its assets for the
benefit of creditors. Each Party agrees to give the other Party
prompt notice of the foregoing events giving rise to termination
under this Section 9.4. All rights and
licenses granted under or pursuant to any section of this Agreement
are and shall otherwise be deemed to be for purposes of Section
365(n) of Title 11, United States Code (the “Bankruptcy Code”) licenses of
rights to “intellectual property” as defined in Section
101(35A) of the Bankruptcy Code. The Parties shall retain and may
fully exercise all of their respective rights and elections under
the Bankruptcy Code. All materials required to be delivered by the
non-bankrupt Party under this Agreement (including all
manufacturing information), and all materials relating to the
Licensed Intellectual Property that, in the course of dealing
between the Parties under this Agreement, are or would be
customarily delivered, shall be considered to be
“embodiments” of such intellectual property for
purposes of Section 365(n) of the Bankruptcy Code. Upon the
bankruptcy of any Party, the non-bankrupt Party shall further be
entitled to a complete duplicate of, or complete access to, any
Intellectual Property licensed to the non-bankrupt Party, and such,
if not already in its possession, shall be promptly delivered to
the non-bankrupt Party, unless the bankrupt Party elects to
continue, and continues, to perform all of its obligations under
this Agreement. All written agreements entered into in connection
with the Parties’ performance under this Agreement from time
to time shall be considered agreements “supplementary”
to this Agreement for purposes of Section 365(n) of the Bankruptcy
Code.

 

 

 

 

9.5

Consequences of Expiration or
Termination. All of the following effects of expiration or
termination, as applicable, are in addition to the other rights and
remedies that may be available to the Parties at law or in
equity.

 

9.5.1

Consequences of Expiration of the Term.
Upon expiration of the Term, as determined on a Licensed
Product-by-Licensed Product and country-by-country basis, Monopar
shall have an exclusive, fully-paid, royalty-free, perpetual right
and license, with the right to grant sublicenses, under all
Licensed Patents and Licensed Know-How to use, sell, offer to sell,
import, make and have made any Licensed Product in the Field and in
the Territory.

 

9.5.2

Consequences of Termination of this Agreement
by Monopar Pursuant to Section 9.3.1
or by Onxeo Pursuant to
Section 9.1.3, 9.2.1, or 9.4. In the event of a termination of this
Agreement in its entirety by Monopar pursuant to Section 9.3.1 or a termination of this Agreement in
its entirety by Onxeo pursuant to Section 9.1.3 (failure to exercise the Monopar
Validive Option) or 9.2.1 (for cause)
or 9.4 (insolvency):

 

(a)

notwithstanding
anything contained in this Agreement to the contrary, all rights
and licenses granted herein to Monopar with respect to any Licensed
Products shall terminate;

 

(b)

all payment
obligations hereunder shall terminate, other than those that are
accrued and unpaid as of the effective date of such
termination;

 

(c)

should Onxeo so
demand, Monopar shall assign to Onxeo any Patents or Know-How
(other than the Licensed Patents and Licensed Know-How) Controlled
by Monopar that Monopar both actually uses and are necessary to
Develop or Commercialize Licensed Products and shall negotiate in
good faith with Onxeo the amount of contingent milestone and/or
royalty payments which shall be the sole consideration for such
assignment. The transfer of such rights to Onxeo shall be
automatically effective upon Onxeo’s demand even if the
amount of each milestone and/or royalty payments are not
determined. In the event that the Parties are not able to agree
amount of milestone and/or royalty payments within three (3) months
after commencement of such negotiations, the dispute shall be
submitted to final and binding arbitration, as provided in Section
10.3

 

 

 

 

(d)

Monopar shall
promptly either, at Onxeo’s election, return to Onxeo or
destroy, at no cost to Onxeo, all Onxeo Licensed Know-How,
Materials, and other data and information transferred by Onxeo to
Monopar, including all Onxeo Licensed Know-How, Validive Materials,
and other information transferred to Monopar pursuant to Section
3.5; and Onxeo, except as provided in
Section 9.5.2(e) or 9.5.2(f) shall promptly either, at
Monopar’s election, return to Monopar or destroy, at no cost
to Monopar, all Monopar Confidential Information;

 

(e)

Monopar will
provide, as soon as reasonably practical after Monopar’s
notice of such termination, to Onxeo, to the extent permitted under
any applicable Third Party contract, (i) any information, Validive
Materials, and data for, including copies of all clinical study
data and results, and all other information, and the like developed
by or for the benefit of Monopar directly and solely relating to
Licensed Products, and (ii) other documents to the extent directly
and solely related to the Licensed Products that are necessary in
the continued Development and Commercialization of Licensed
Products throughout the Territory. Notwithstanding the foregoing,
this Section 9.5.2(e) shall not apply
in the case of a termination of this Agreement in its entirety by
Onxeo pursuant to Section 9.1.3
(failure to exercise the Monopar Validive Option); and

 

(f)

should Onxeo so
demand, Monopar shall assign to Onxeo any and all title to
Regulatory Approvals directly and solely related to Licensed
Products (including orphan drug designations), all title to
Licensed Intellectual Property or registrations thereof, and
Regulatory Filings directly and solely related to Licensed
Products; provided that this Section 9.5.2(f) shall also apply in the case of a
termination of this Agreement in its entirety by Onxeo pursuant to
Section 9.1.3 (failure to exercise the
Monopar Validive Option).

 

 

 

 

9.5.3

Consequences of Termination by Monopar Pursuant
to Section 9.2.1 or 9.4. In the event of termination by Monopar
of this Agreement in its entirety or with respect to a Licensed
Product pursuant to Section 9.2 (for
cause) or pursuant to Section 9.4
(insolvency):

 

(a)

all licenses
granted to Monopar with respect to Licensed Products shall continue
in full force in perpetuity;

 

(b)

all future
milestones and royalties payable by Monopar under this Agreement
shall be reduced by a percentage agreed to by Monopar and Onxeo. In
the event the Parties are not able to agree on the percentage
amount within three (3) months after commencement of such
negotiations, the dispute shall be submitted to final and binding
arbitration as provided in Section 10.3; and

 

(c)

Onxeo shall
promptly either, at Monopar’s election, return to Monopar or
destroy, at no cost to Monopar, all Monopar Confidential
Information, materials, and other data and information transferred
by Monopar to Onxeo.

 

9.5.4

Sell-Down. If Monopar, its Affiliates or
Sublicensees at termination of this Agreement possess Licensed
Product, have started the manufacture thereof or have accepted
orders therefor, Monopar, its Affiliates or Sublicensees shall have
the right, for up to one (1) year following the date of
termination, to sell their inventories thereof, complete the
manufacture thereof and Commercialize such fully-manufactured
Licensed Product, in order to fulfill such accepted orders or
distribute such fully-manufactured Licensed Product, but only in
the ordinary course of business and on the same terms and
conditions of sale as previously applied and subject to the
obligation of Monopar to pay Onxeo any and all payments as provided
in this Agreement.

 

9.6

Provisions to continue on termination.
The termination of this Agreement howsoever arising will be without
prejudice to the rights and duties of either Party accrued prior to
termination. The following Articles will continue to be enforceable
notwithstanding termination: Articles 6, 8, 10 and 11 and
Sections 4.5, 4.6, 4.7,
4.8, 4.9,
4.10, 4.11, 5.1,
5.2, 7.1
and 9.5 inclusive.

 

 

 

 

10.

DISPUTE RESOLUTION

 

10.1

The Parties
recognize that disputes as to certain matters arising under this
Agreement may arise from time-to-time. It is the objective of the
Parties to seek to resolve any disputes arising under this
Agreement in an expedient manner and, if at all possible, without
resort to litigation, and to that end the Parties agree to abide by
the procedures set forth in this Section 10 to resolve any such disputes. The Parties
initially shall attempt to resolve any issues through good faith
negotiations in the spirit of mutual cooperation between senior
managers of the Parties with authority to resolve the dispute, for
a period of thirty (30) days after receipt of the first notice by
either Party requesting negotiations. Should any issue not be
timely resolved by good faith negotiations, any dispute with
respect thereto shall be submitted to final and binding
arbitration, as provided below.

 

10.2

Any controversy
or claim arising out of or relating to this Agreement, or the
interpretation or breach thereof, shall be resolved by final and
binding arbitration administered by the International Centre for
Dispute Resolution in accordance with its International Arbitration
Rules as then in force. The number of arbitrators shall be three
(3), or one (1) if the amount in controversy is less than one
million dollars ($1,000,000), and the place of arbitration shall be
New York County, New York. When three (3) arbitrators are required
based on the amount in controversy, each Party shall appoint an
arbitrator and the Parties shall mutually agree on the appointment
of the third arbitrator. When one (1) arbitrator is required based
on the amount in the controversy, the Parties shall mutually agree
on the appointment of an arbitrator within one (1) month of
submission of the request for arbitration, failing which the sole
arbitrator shall be selected by the International Centre for
Dispute Resolution. The language of the arbitration shall be
English. The arbitrator(s) shall be entitled to award interim and
conservatory relief to the fullest extent permitted by New York
law, shall apply the International Bar Association Rules on the
Taking of Evidence in International Commercial Arbitration as now
in effect, and shall otherwise apply New York procedural
law.

 

10.3

In the event
that the Parties are unable to complete negotiations as described
in the definition of “Net Sales”, in Section 9.5.2(c) or in Section 9.5.3(b) within the
time period there indicated, each Party shall, no later than the
last day of such period, submit its final and best offer to the
other Party, and a single arbitrator appointed pursuant to Section
10.2 (and without further negotiations
as provided in Section 10.1), whose
sole authority shall be to select one of the final offers so
submitted.

 

 

 

 

[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

11.

MISCELLANEOUS

 

11.1

Severability. If any one or more of the
provisions of this Agreement is held to be invalid or
unenforceable, the provision shall be considered severed from this
Agreement and shall not serve to invalidate any remaining
provisions hereof. The Parties shall make a good faith effort to
replace any invalid or unenforceable provision with a valid and
enforceable one such that the objectives contemplated by the
Parties when entering this Agreement may be realized.

 

11.2

Notices. All notices shall be in writing
and sent by hand, email, or recorded delivery and shall be deemed
to be properly served: (i) if sent by hand, when delivered at the
relevant address; (ii) if sent by recorded delivery, three (3)
Business Days after posting; (iii) if sent by email, when
transmitted, provided a confirmatory copy is sent by post within
twenty four (24) hours of transmission, and shall be sent to the
following addresses or email address as may be amended by the
relevant Party in writing:

 

If to
Onxeo:

 

Onxeo
S.A.

49,
boulevard du Général Martial Valin, 1st Floor

75015
Paris, France

Attention: Judith
Greciet

email:
[***]

 

If to
Monopar:

 

Monopar
Therapeutics Inc.

598
Rockefeller Rd

Lake
Forest, IL 60045

Attention: Chandler
Robinson

email:
[***]

 

11.3

Variation. No variation, modification,
amendment, extension or release from any provision of this
Agreement shall be effective unless it is in writing, signed by
both Parties.

 

11.4

Force Majeure. Except for the payment of
money, neither Party shall be liable for delay or failure in the
performance of any of its obligations hereunder if such delay or
failure is due to causes beyond its reasonable control, including
acts of God, fires, earthquakes, acts of war, terrorism, or civil
unrest (“Force
Majeure”); provided, however, that the affected Party
promptly notifies the other Party and further provided that the
affected Party shall use its Commercially Reasonable Efforts to
avoid or remove such causes of non-performance and to mitigate the
effect of such occurrence, and shall continue performance with the
utmost dispatch whenever such causes are removed. When such
circumstances arise, the Parties shall negotiate in good faith any
modifications of the terms of this Agreement that may be necessary
or appropriate in order to arrive at an equitable
solution.

 

 

 

 

11.5

Entire Agreement. This Agreement and the
attached Schedules constitutes the entire agreement between the
Parties as to the subject matter of this Agreement, and supersedes
and merges all prior and contemporaneous negotiations,
representations, agreements and understandings regarding the
same.

 

11.6

Further Assurance. Each Party hereby
undertakes to do all such other acts and things, and execute and
provide all such documents at the other Party's request and cost as
may be necessary or desirable to give effect to the purposes of
this Agreement.

 

11.7

Waiver. No relaxation, forbearance,
waiver or indulgence by either Party in enforcing any of the terms
or conditions of this Agreement or the granting of time by either
Party to the other shall prejudice, affect or restrict the rights
and powers of such Party, unless contained in a writing signed by
the Party charged with such waiver. The waiver of any breach of any
term or any condition of this Agreement shall not be construed as a
waiver of any subsequent breach of a term or condition of the same
or of a different nature.

 

11.8

Relationship of the Parties. Each Party
is an independent contractor under this Agreement. Nothing
contained herein is intended or is to be construed so as to
constitute Onxeo and Monopar as partners, agents or joint
venturers. Neither Party shall have any express or implied right or
authority to assume or create any obligations on behalf of or in
the name of the other Party or to bind the other Party to any
contract, agreement or undertaking with any Third Party. There are
no express or implied third party beneficiaries
hereunder.

 

11.9

Execution. This Agreement may be
executed in any one or more number of counterpart agreements, and
as scanned email attachments, and all signatures and counterparts
so exchanged shall be considered as original and shall be deemed to
form part of and together constitute this Agreement.

 

11.10

Assignment. Neither Party may, without
the consent of the other Party, assign or transfer any of its
rights and obligations hereunder; provided that no such consent is
required for an assignment or transfer to an Affiliate of or to a
successor in interest by reason of merger or consolidation or sale
of all or substantially all of the assets of such Party relating to
the subject matter of this Agreement; provided further that (a)
with respect to an assignment to a successor in interest, such
assignment includes all rights and obligations under this
Agreement, (b) such successor in interest or Affiliate shall have
agreed as of such assignment or transfer to be bound by the terms
of this Agreement in a writing provided to the non-assigning Party,
and (c) where this Agreement is assigned or transferred to an
Affiliate, the assigning Party remains responsible for the
performance of this Agreement. Subject to the foregoing, this
Agreement shall inure to the benefit of and be binding on the
Parties’ successors and assigns. Any assignment or transfer
in violation of the foregoing shall be null and void and wholly
invalid, the assignee or transferee in any such assignment or
transfer shall acquire no rights whatsoever, and the non-assigning,
non-transferring Party shall not recognize, nor shall it be
required to recognize, such assignment or transfer.

 

 

 

 

11.11

Public Announcements. The text of any
press release, shareholders’ report or other communication to
be published or disclosed in any way naming the other Party or this
Agreement, other than as required by law or by any regulatory or
government authority, shall be submitted to the other Party at
least seven (7) days in advance of publication or disclosure for
approval, such approval not to be unreasonably withheld; provided
that insofar as a disclosure repeats or restates a prior public
disclosure permitted by this Agreement, such disclosure need not be
submitted to the other Party for approval.

 

11.12

Governing Law. This Agreement shall be
governed by and construed in accordance with the laws of the State
of New York without giving effect to the principles of conflicts of
laws (other than Section 5-1401 of the New York General Obligations
Law).

 

 

[Signature Page Follows]

 

 

 

 

 

 

IN WITNESS whereof this Agreement has been executed by duly
authorized officers of the Parties on the day first above
written.

 

For and
on behalf of ONXEO
S.A.

 

 

Signed
by:    

/s/ Judith Greciet

 

Name:                                 

Judith Greciet

 

Title:                                 

CEO

 

 

 

For and
on behalf of MONOPAR THERAPEUTICS
INC.

 

 

Signed
by:

/s/ Chandler D. Robinson

 

Name:     

Chandler D. Robinson

 

Title:    

CEO

 

 

 

 

 

 

[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

SCHEDULE
1

 

LICENSED
PATENTS

 

 

 

    
           
           
           
           
           
        Validive patent status
26/04/20

 

	
 Onxeo's
Reference

	
 Country/Region 

	
 Application
Number

	
 Grant
Date

	
 Patent
Number

	
 Status

	
 [***]

	
[***] 

	
[***] 

	
[***] 

	
[***] 

	
[***] 

 

	
  Onxeo's
Reference

	
  Country/Region 

	
 Application
Number

	
 Grant
Date

	
  Patent
Number

	
Status

	
 [***]

	
 [***]

	
 [***]

	
 [***]

	
 [***]

	
 [***]

 

 

 

 

SCHEDULE
2

 

 

LICENSED
KNOW-HOW

 

The
Licensed Know-How shall include all regulatory and technical
documents that the personnel of Onxeo responsible for Development
and Commercialization of Onxeo’s products maintain in the
ordinary course of business with respect to the Licensed Products,
including:

 

(1)

a copy of the
submissions to and correspondence to and from the regulatory
authorities;

 

(2)

the list of the
composition thereof;

 

(3)

reports and filings
concerning complaints and adverse incidents not otherwise provided;
and

 

(4)

marketing and
promotional materials, if any.

 

 

 

 

 

[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

 

SCHEDULE 3

 

 

LICENSED
TRADEMARKS

 

 

 

	

ONXEO-Ref

 

	

Title

 

	

Jurisdiction

 

	

Filing Number

 

	

Filing Date

 

	

Registration Number

 

	

Registration Date

 

	

[***]

 

	

[***]

 

	

[***]

 

	

[***]

 

	

[***]

 

	

[***]

 

	

[***]

 

 

 

 

 

 

 

[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

SCHEDULE 4

 

 

VALIDIVE
MATERIALS

 

	

[***]

	

[***]

	

[***]

	

[***]

 

 

	

Raw
materials

	
 

	
 

	
 

	

Description

	

Expiry

	
[***]	

[***]

	

[***]
(development)

	

[***]

	
 

	
 

 

	

Stability
Study

	
 

	
 

	
 

	
 

	
 

	

Description

	

Study
point ongoing

	

Location

	

Clinical Batches

	

[***]

	

[***]

	

[***]

	

Technical Batches

	
 
[***]   
           
           
           
           
           
           
          
[***]           
           
           
           
           
           
[***]

	
 

	
 

	
 

 

 

 

 

SCHEDULE
5

 

CONFIRMATORY
PATENT LICENSE

 

THIS DEED is made the ___________day
of______________________201[●]

 

1) 

MONOPAR THERAPEUTICS INC, whose
principal office is 598 Rockefeller Road, Lake Forest, Illinois,
USA, 60045 (“Monopar”); and

 

2) 

ONXEO S.A., with its principal place of
business located at 49, boulevard du Général Martial
Valin, 75015 Paris, France (hereinafter “Onxeo”).

 

RECITALS:

 

By an
agreement (the “Main
Agreement”) dated __________________ and made between
Monopar and Onxeo. Onxeo agreed for the consideration therein
contained, among other things, to grant to Monopar a license under
[Country/region Patent
No.__________] (the “Patent”) of which this
Agreement is a confirmatory license.

 

OPERATIVE
PROVISIONS:

 

1. 

In pursuance of the
Main Agreement and for the consideration referred to in the Main
Agreement Onxeo hereby grants to Monopar the exclusive license from
the ________ day of_____________ 20___ to research, develop, use,
keep, make, have made, import, sell and otherwise dispose of
Licensed Products (as defined in the Main Agreement) in the Field
(as defined in the Main Agreement) in the Territory (as defined in
the Main Agreement) for the life of the Patent and subject to the
provisions of the Main Agreement.

 

2. 

Subject to the
provisions of the Main Agreement this Agreement shall terminate
without notice in the event of the termination of the Main
Agreement in accordance with its terms.

 

IN
WITNESS of which this Agreement has been executed as a deed and
delivered the day and year first above written.

 

	

EXECUTED
as a deed

 

	

)

 

	

Name
(PRINT):                                                            

 

	

For and
on behalf of

 

	

)

 

	

Title
(PRINT):                                                            

 

	

ONXEO S.A.

 

	

)

 

	

Signature:                                                            

 

	
 

	

)

 

	

Date:                                                            

 

	
 

	
 

	
 

	
 

	

)

 

	

Name
(PRINT)                                                            

 

	
 

	

)

 

	

Title
(PRINT)                                                            

 

	
 

	

)

 

	

Signature:                                                            

 

	
 

	

)

 

	

Date:                                                            

 

 

 

acting
by a Director and its Secretary / two Directors

 

	

EXECUTED
as a deed

 

	

)

 

	

Name
(PRINT):                                                            

 

	

For and
on behalf of

 

	

)

 

	

Title
(PRINT):                                                            

 

	

MONOPAR THERAPEUTICS INC

 

	

)

 

	

Signature:                                                            

 

	
 

	

)

 

	

Date:                                                            

 

	
 

	
 

	
 

	
 

	

)

 

	

Name
(PRINT)                                                            

 

	
 

	

)

 

	

Title
(PRINT)                                                            

 

	
 

	

)

 

	

Signature:                                                            

 

	
 

	

)

 

	

Date:                                                            

 

acting
by a Director and its Secretary / two Directors

 

 

 

 

 

AMENDMENT No. 1 to VALIDIVE OPTION AND LICENSE
AGREEMENT

 

This
amendment number one (“Amendment”) to the Validive Option
and License Agreement dated June 17, 2016 (the “Agreement”) is by and between
Monopar Therapeutics Inc., a Delaware corporation having a place of
business at 5 Revere Drive, Suite 200, Northbrook, Illinois 60062
(“Monopar”), and
Onxeo S.A., a French société anonyme à Conseil
d’administration located at 49, boulevard du
Général Martial Valin, 75015 Paris, France
(“Onxeo”).
Monopar and Onxeo shall also hereinafter be referred to as a Party
or collectively as the Parties.

 

RECITALS

WHEREAS, the
Parties entered into the Agreement effective June 17, 2016
(“Effective
Date”);

 

WHEREAS, Monopar
has exercised the licensing option and paid the License Fee as
provided in the Agreement; and

 

WHEREAS, the
Parties now wish to amend the Agreement as more particularly set
forth below.

 

NOW,
THEREFORE, in consideration of the covenants contained herein the
Parties hereto, intending to be legally bound hereby, agree to and
hereby do amend the Agreement as follows:

 

1. 

All capitalized
terms used herein and not otherwise defined shall have the same
meaning as defined in the Agreement.

 

2. 

Schedule 3 of the
Agreement is replaced in its entirety with the attached Schedule
3.

 

3. 

For the avoidance
of doubt, the Trademarks added to Schedule 3 by this Amendment
(“Additional
Trademarks”) shall be deemed Licensed Trademarks under
the Agreement as of the Effective Date and within the rights
granted by Onxeo to Monopar including assignment upon
Monopar’s exercise of the Monopar Validive
Option.

 

4.
Onexo agrees to execute and deliver documents as may be necessary
or desirable to give effect to the assignment of the Additional
Trademarks.

 

5. 

Except as otherwise
amended hereby, the Agreement shall remain in full force and effect
as presently written, and the rights, duties, liabilities and
obligations of the Parties thereto will continue in full
effect.

 

 

IN
WITNESS WHEREOF, the Parties have caused this Amendment to be
executed by their duly authorized representatives, effective of the
Effective Date.

 

	

MONOPAR
THERAPEUTICS INC.

Signature:
/s/ Chandler D.
Robinson

Print
Name: Chandler Robinson   

Title:
CEO

	

ONXEO
S.A.

Signature:
/s/ Judith
Greciet

Print
Name: Judith Greciet   

Title:
CEO

 

 

 

 

[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission. 

Confidential
treatment has been approved with respect to the omitted
information, pursuant to an Order dated January 8,
2018.

 

Schedule 3 Licensed Trademarks

 

	

Title

	

Jurisdiction

	

Filing
Number

	

Filing
Date

	

Registration
Number

	

Registration
Date

	

[***]

	

[***]

	

[***]

	

[***]

	

[***]

	

[***]

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