VALIDIVE® OPTION AND LICENSE AGREEMENT BY AND BETWEEN MONOPAR THERAPEUTICS INC. AND ONXEO S.A.
[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission.
Confidential
treatment has been requested with respect to the omitted
information.
VALIDIVE®
OPTION AND LICENSE AGREEMENT
BY AND
BETWEEN
MONOPAR
THERAPEUTICS INC.
AND
ONXEO S.A.
TABLE OF CONTENTS
|
1.
|
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
|
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 000 Xxxxxxxxxxx Xx, Xxxx Xxxxxx, Xxxxxxxx 00000, Xxxxxx Xxxxxx
of America (“Monopar”), and Onxeo S.A., a
French société anonyme
à Conseil d’administration located at 00,
xxxxxxxxx xx Xxxxxxx Xxxxxxx Xxxxx, 00000 Xxxxx, Xxxxxx
(“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:
1.1
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 requested with respect to the omitted
information.
“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 xxxx, service name, brand xxxx,
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 requested with respect to the omitted
information.
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.
2.1
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”).
[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission.
Confidential
treatment has been requested with respect to the omitted
information.
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.
3.1.1
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 requested with respect to the omitted
information.
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.
4.1
Option Fee. [***] for entering into this
Agreement.
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.
(a)
[***] upon [***]
for a Licensed Product;
[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission.
Confidential
treatment has been requested with respect to the omitted
information.
(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.
4.6.1
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.
4.8
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.
4.9.1
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.
4.11.1
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 requested with respect to the omitted
information.
(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).
5.1
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.
[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission.
Confidential
treatment has been requested with respect to the omitted
information.
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 requested with respect to the omitted
information.
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.
6.1
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.
7.1.1
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 requested with respect to the omitted
information.
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.
8.1
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.
9.1.1
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 requested with respect to the omitted
information.
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.
9.2.1
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 requested with respect to the omitted
information.
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 Xxxxx 00, Xxxxxx Xxxxxx 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.
9.5.1
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).
(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.
10.1
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 requested with respect to the omitted
information.
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.
00,
xxxxxxxxx xx Xxxxxxx Martial Xxxxx, 0xx Xxxxx
00000
Xxxxx, Xxxxxx
Attention: Xxxxxx
Xxxxxxx
email:
[***]
If to
Monopar:
Monopar
Therapeutics Inc.
000
Xxxxxxxxxxx Xx
Xxxx
Xxxxxx, XX 00000
Attention: Xxxxxxxx
Xxxxxxxx
email:
[***]
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.
[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/ Xxxxxx Xxxxxxx
Name:
Xxxxxx Xxxxxxx
Title:
CEO
For and
on behalf of MONOPAR THERAPEUTICS
INC.
Signed
by:
/s/ Xxxxxxxx X. Xxxxxxxx
Name:
Xxxxxxxx X. Xxxxxxxx
Title:
CEO
[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission.
Confidential
treatment has been requested with respect to the omitted
information.
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
|
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
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 requested with respect to the omitted
information.
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 requested with respect to the omitted
information.
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 000 Xxxxxxxxxxx Xxxx, Xxxx Xxxxxx, Xxxxxxxx,
XXX, 00000 (“Monopar”); and
2)
ONXEO S.A., with its principal place of
business located at 00, xxxxxxxxx xx Xxxxxxx Xxxxxxx
Xxxxx, 00000 Xxxxx, Xxxxxx (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):
|
|
|
)
|
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 0 Xxxxxx Xxxxx, Xxxxx 000, Xxxxxxxxxx, Xxxxxxxx 00000
(“Monopar”), and
Onxeo S.A., a French société anonyme à Conseil
d’administration located at 00, xxxxxxxxx xx
Xxxxxxx Xxxxxxx Xxxxx, 00000 Xxxxx, Xxxxxx
(“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/ Xxxxxxxx X.
Xxxxxxxx
Print
Name: Xxxxxxxx Xxxxxxxx
Title:
CEO
|
ONXEO
S.A.
Signature:
/s/ Xxxxxx
Xxxxxxx
Print
Name: Xxxxxx Xxxxxxx
Title:
CEO
|
[***] = Confidential Information has
been omitted and filed separately with the Securities and Exchange
Commission.
Confidential
treatment has been requested with respect to the omitted
information.
Schedule 3 Licensed Trademarks
|
Title
|
Jurisdiction
|
Filing
Number
|
Filing
Date
|
Registration
Number
|
Registration
Date
|
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
