[***] = 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.
 

            

 

[onxeo_logo.jpg]
 
 

[exhibit_10-1001.jpg]
 
 
 
 

 
 

 

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
[***]
[***]

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