Exhibit 10.1
DEFINITIVE MASTER AGREEMENT
BETWEEN
MDI ONCOLOGY, INC.
AND
EUCODIS FORSCHUNGS-und ENTWICKLUNGS GmbH
Dated as of
July 29, 2006
DEFINITIVE MASTER AGREEMENT
This Definitive Master Agreement ("Agreement") is made and entered into
as of July 29, 2006 by and between MDI Oncology, Inc. ("MDI"), a Delaware
corporation, whose principal place of business is 0000 X. Xxxxxxxx Xxxxx, #000,
Xxxx Xxxx Xxxx, Xxxx 00000 and Eucodis Forschungs -- und Entwicklungs GmbH
("Eucodis"), an Austrian company whose principal place of business is Xxxxxxx
Xxx. 00, 0000, Xxxxxx, Xxxxxxx (collectively MDI and Eucodis shall be referred
to as the "Parties").
RECITALS
WHEREAS, MDI, through an asset purchase, has an ownership interest in a
pharmaceutical product known as the "Product";
WHEREAS, MDI wishes to have preclinical, clinical, manufacturing and
all other development begun for the Product for purposes of either outlicensing
and/or commercializing the Product;
WHEREAS, Eucodis has represented that it has the requisite expertise,
understanding and scientific knowledge to undertake such development under the
terms and conditions hereinafter set forth;
WHEREAS, MDI has disclosed the means by which it acquired the ownership
rights to the intellectual property related to the Product and any risk or
liabilities associated therewith and Eucodis has disclosed the extent of its
experience in product development for the oncology field; and
WHEREAS, both Parties accept the representations made by the other,
have executed a Letter of Intent and wish to enter into this Agreement whereby a
license in the Field for the Eucodis Territory market is given by MDI to Eucodis
and Eucodis shall pay certain agreed upon sums of money, engage in all
development activities necessary to complete clinical trials as set forth herein
and to then either outlicense the Product or proceed into Phase III through to
commercialization.
NOW, THEREFORE, in consideration of the mutual covenants, agreements,
representations and warranties herein, the Parties hereby agree as follows:
1. DEFINITIONS.
1.1 "AFFILIATE" shall mean, with respect to any Person, any other
Person controlling, controlled by or under direct or indirect common control
with such Person. A Person shall be deemed to control a corporation (or other
entity) if such Person possesses, directly or indirectly, the power to direct or
cause the direction of the management and policies of such corporation (or other
entity), whether through the ownership of voting securities, by contract or
otherwise.
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1.2 "AGREEMENT" shall mean this Definitive Master Agreement and all
Exhibits and Schedules attached hereto including the Letter of Intent ("LOI")
dated April 24, 2006, as the same may be amended or otherwise modified from time
to time pursuant to the terms set forth herein. To the extent that the LOI
contradicts this Agreement, this Agreement controls.
1.3 "BANKRUPT COMPANY" shall mean SaveTherapeutics AG, a German
corporation from whom certain intellectual property was purchased by MDI,
including, but not limited to, the Product.
1.4 "CLINICAL DEVELOPMENT PLAN" shall mean the outline and any and all
amendments thereto made during the term of this Agreement, the initial copy of
which has been tendered to MDI as part of the Conditions Precedent is attached
hereto as Exhibit A and incorporated herein and made part of this Agreement
along with all subsequent amendments.
1.5 "CONFIDENTIAL INFORMATION" shall mean information owned by either
Party in any medium, including oral, written or electronic, disclosed in
connection with this Agreement, along with any trade secrets, business
information, technical information, or marketing information that the Disclosing
Party deems proprietary and has appropriately marked as such prior to disclosing
such Confidential Information to the Receiving Party.
1.6 "DISCLOSING PARTY" shall mean a Party disclosing Confidential
Information to another Party and may include MDI, Eucodis or both.
1.7 "EUCODIS TERRITORY" shall mean the EU and all those countries
listed in Exhibit D attached hereto and made a part of this Agreement.
1.8 "EUROPEAN UNION" or "EU" shall mean those countries which are
members of the European Union at the time of the execution of this Agreement and
including Croatia, Norway, Switzerland and Turkey.
1.9 "EUROPEAN UNION DIRECTIVES AND REGULATIONS" or "EU REGULATIONS" OR
"EU DIRECTIVES" shall mean all directives and regulations of the European Union
and all directives and regulations of those European member countries related,
or relevant to, drug development and commercialization.
1.10 "FDA" shall mean the United States Food and Drug Administration or
any successor agency.
1.11 "FACILITY" OR "FACILITIES" shall mean the site where Eucodis
selects to have all manufacturing of the Product done.
1.12 "FEDERAL FOOD, DRUG AND COSMETIC ACT" or "ACT" shall mean the
federal statute so entitled and all regulations and guidance documents
promulgated thereunder.
1.13 "FIELD" shall mean the development and commercialization of the
Product for use in breast cancer and related breast cancer and mastalgy
indications.
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1.14 "GOOD MANUFACTURING PRACTICES" or "GMP" shall have the meaning set
forth in the Act and the corresponding EU Directives.
1.15 "GOVERNMENTAL AUTHORITY" means any court, tribunal, arbitrator,
agency, commission, official or other instrumentality of the United States,
European Union or any other jurisdiction applicable to the subject matter
contemplated in this Agreement.
1.16 "INADVERTENT DISCOVERY" shall mean any invention, patentable or
not patentable, which directly and specifically relates to the Intellectual
Property having application outside the Field, which is conceived, developed or
reduced to practice by either Party during the term of this Agreement.
1.17 "INTELLECTUAL PROPERTY" shall mean the Product, any improvements
thereto and all related inventions, rights in confidential information
(including know-how and trade secrets) and any other intellectual property
rights, now or hereafter owned, acquired or developed by or on behalf of MDI or
MDI's Affiliates or third party contractors to MDI, as the case may be, during
the term of this Agreement, in each case whether registered or unregistered, and
including all applications for and renewals or extensions of such rights, and
all similar or equivalent rights or forms of protection.
1.18 "NET REVENUES" shall mean the gross cash receipts the Party or it
Affiliate obtains from any unrelated third party in respect of the Product, [* *
*].
1.19 "MDI TERRITORY" shall mean the entire world and all its markets
except for the Eucodis Territory.
1.20 "PERSON" shall mean any individual or corporation, partnership,
trust, incorporated or unincorporated association, joint venture or other entity
of any kind.
1.21 "PHASE II" and/or "PHASE III" shall have the same meaning as set
forth in the Act and/or the corresponding EU Directives for clinical trials. For
purposes of this Agreement, all references to Phase II shall mean the completion
of Phase II requirements for [* * *].
1.22 "PRODUCT" shall mean the Formestane Cream, ointment, or topical
application as set forth in [* * *].
1.23 "RECALL", with respect to any Product, shall mean a "recall",
"correction" or "market withdrawal", as those terms are defined in 21 CFR 7.3,
as the same may be amended from time to time, and shall include any post-sale
warning or mailing of information regarding such Product, including those
warnings or mailings described in 21 CFR 200.5.
1.24 "RECEIVING PARTY" shall mean a Party receiving Confidential
Information and may include MDI, Eucodis or both.
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1.25 "SPECIFICATIONS" shall mean the specifications for the raw
materials and packaging materials used in the manufacture and/or packaging of
the Product and the specifications for the manufacture, processing and packaging
of the Product, including all formula, know-how, materials requirements,
standards of quality control, quality assurance and sanitation, as as soley
determined by EUCODIS in Phase II and mutually agreed upon in writing by MDI and
Eucodis after Phase III.
1.26 "STEERING COMMITTEE" shall mean the committee formed pursuant to
Section 13 of this Agreement.
2. REPRESENTATIONS AND WARRANTIES OF MDI. MDI hereby represents and
warrants to Eucodis as follows:
2.1 ORGANIZATION. MDI is a corporation duly organized validly existing
and in good standing under the laws of the State of Delaware, United States of
America, and has all requisite power and authority to own its assets and to
carry on its business as presently conducted. MDI purchased from the bankruptcy
estate of the Bankrupt Company, as disclosed to Eucodis, the assets thereof,
including, but not limited to, the Product.
2.2 AUTHORITY. MDI has all requisite power and authority to execute and
deliver and perform its obligations under this Agreement and to consummate the
transactions contemplated by this Agreement.
2.3 OWNERSHIP. MDI has engaged in disclosure and offered the documents
it knows of, and which are in its possession concerning or related to the
purchase of the Intellectual Property of the Bankrupt Company and the status of
the transfer of those same assets to MDI from the Bankrupt Company. MDI further
warrants that it has, to the best of its knowledge, responded to the inquiries
by Eucodis concerning the subsequent assignment of such Intellectual Property
and the pending litigation in Germany to effectuate the EU ownerships rights
subsequent to MDI's purchase of such Intellectual Property. MDI has provided to
Eucodis updated information concerning the Status of the Intellectual Property
as related to the Product in the Eucodis Territory, including but not limited to
[***].
2.4 THIRD PARTIES. MDI represents and warrants that it has not granted
a license for the Product, exclusive or otherwise to any other entity or company
for the Field in the Eucodis Territory.
2.5 COVENANT. MDI hereby covenants that it will continue to provide
information, as it learns of such information, related to the Intellectual
Property to Eucodis. MDI further covenants that it will pursue assignment of the
such Intellectual Property where such assignment has not yet been effectuated in
the Eucodis Territory. MDI will undertake those acts as may be commercially
reasonable to maintain the patents in the Eucodis Territory which are in force
or which may become enforceable by MDI, including but not limited to [***]. MDI
shall pay all costs for patent filings necessary to protect or related to the
Intellectual Property.
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2.6 DISCLAIMER. All representations and warranties not expressly made
herein, are deemed by the Parties not to have been made or are expressly
disclaimed.
2.7 VALID AND BINDING AGREEMENT. All acts and approvals required to be
taken by or on the part of MDI (corporate or otherwise) necessary to enter into
this Agreement, consummate the transactions contemplated by this Agreement and
perform its obligations under this Agreement have been duly and properly taken
by MDI. This Agreement has been duly and validly executed and delivered by MDI,
and with it the legal, valid and binding obligation of MDI, enforceable against
MDI in accordance with its terms, subject to applicable bankruptcy, insolvency
and similar laws affecting creditors' rights generally and to general principles
of equity.
2.8 NO VIOLATION , ETC. The execution and delivery of this Agreement by
MDI, the consummation by it of the transactions contemplated by this Agreement,
and the performance by it of its obligations under this Agreement does not, and
will not at all relevant times, (i) violate or conflict with any provision of
the charter documents of MDI; (ii) violate, or conflict with, or result in a
breach of any provision of, or constitute a default (or give rise to any right
of termination, cancellation or acceleration) under, any of the terms,
conditions or provisions of any agreement lease, instrument, obligation,
understanding or arrangement to which MDI is a party or by which any of MDI's
properties or assets is subject, or (iii) result in a violation by MDI of any
law to which MDI or any of its properties or assets are subject. There is no
litigation, proceeding, investigation, arbitration or claim pending, or, to
MDI's knowledge, threatened against MDI, and there is, to MDI's knowledge, no
reasonable basis for any such action, which affects in whole or in part MDI's
ability to consummate the transactions contemplated by this Agreement or the
performance of MDI's obligations hereunder.
2.9 CONSENTS AND APPROVALS; TRANSFER. No permit, consent, approval or
authorization of, or declaration, filing or registration with, any Governmental
Authority or other third party is or will be necessary to be made or obtained by
MDI in connection with (i) the execution and delivery by MDI of this Agreement,
(ii) the consummation by it of the transactions contemplated under this
Agreement, or (iii) the performance by MDI of its obligations under this
Agreement except as set forth herein.
3. REPRESENTATIONS AND WARRANTIES OF EUCODIS. Eucodis hereby represents
and warrants to MDI as follows:
3.1 ORGANIZATION. Eucodis is a company duly organized, validly existing
and in good standing under the laws of Austria and has all requisite power and
authority to own its assets and to carry on its business as presently conducted.
3.2 AUTHORITY. Eucodis has all requisite power and authority to execute
and deliver and perform its obligations under this Agreement and to consummate
the transactions contemplated hereby, including the exclusive right to develop
and commercialize the Product.
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3.3 FINANCING. Eucodis hereby warrants and represents that it has the
money available to pay MDI under Section 12.1 of this Agreement and that such
payment will have priority over all other claims made as permitted by law.
3.4 DUE DILIGENCE. Eucodis represents and warrants that it has had
ample opportunity to and in fact has engaged in extensive due diligence
concerning the science of the Product, the business practices of the Bankrupt
Company and any irregularities related thereto, and has reviewed all documents
memorializing the science and transfer of the Intellectual Property. Eucodis
further represents and warrants that prior to entering into this Agreement it
has been fully informed of the pending litigation and/or dispute in Germany to
effectuate all EU ownership rights in the Eucodis Territory in those countries
which have not yet recognized MDI's ownership in the Product. Eucodis
represents, warrants and covenants that it fully aware of any risks attendant to
MDI's purchase from the Bankrupt Company and accepts such risks. Eucodis
acknowledges that no valid Product patent will be obtained in either [***], but
that the license hereunder is extended to those countries.
3.5 CONDITIONS PRECEDENT. The Parties acknowledge that the following
Conditions Precedent must have been performed and completed by Eucodis prior to
the execution of this Agreement:
a) Eucodis has provided MDI evidence that it has the funds to
make the payments to MDI as set forth in Section 12.1 herein;
b) Eucodis has provided MDI a copy of the data concerning the
potential market for the Intellectual Property which Eucodis has provided to its
investors which is attached as Exhibit B hereto;
c) Eucodis has provided to MDI any and all information that it
has obtained on work commissioned by the Bankrupt Company concerning the
development of the Product which is attached as Exhibit C hereto; and
d) Eucodis has provided to MDI its outline plan to finance the
Clinical Development Plan and to make the milestone payments set forth in
Section 12.1 herein.
3.6 COVENANT. Eucodis hereby covenants that it will continue to provide
information as it learns of such information to MDI, related to the Intellectual
Property. Eucodis further covenants that a complete Clinical Development Plan
will be delivered to MDI within [***] of execution of this Agreement and Eucodis
further covenants that updates of that Plan will be provided to MDI as the
Clinical Development Plan is amended throughout the term of this Agreement.
3.7. DISCLAIMER. All representations and warranties not expressly made
herein, are deemed by the Parties not to have been made and expressly
disclaimed.
3.8. VALID AND BINDING AGREEMENT. All acts and approvals required to be
taken by or on the part of Eucodis (corporate or otherwise) necessary to enter
into this Agreement,
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consummate the transactions contemplated by this Agreement and perform its
obligations under this agreement have been duly and properly taken by Eucodis.
This Agreement has been duly and validly executed and delivered by Eucodis, and
it is the legal, valid and binding obligation of Eucodis, enforceable against
Eucodis in accordance with its terms, subject to applicable bankruptcy,
insolvency and similar laws affecting creditors' rights generally and to general
principles of equity.
3.9. NO VIOLATION , ETC. The execution and delivery of this Agreement
by Eucodis, the consummation by it of the transactions contemplated by this
Agreement, and the performance by it of its obligations under this Agreement
does not, and will not at all relevant times, (i) violate or conflict with any
provision of the charter documents of Eucodis, (ii) violate, or conflict with,
or result in a breach of any provision of, or constitute a default (or give rise
to any right of termination, cancellation or acceleration) under, any of the
terms, conditions or provisions of any agreement lease, instrument, obligation,
understanding or arrangement to which Eucodis is a party or by which any of
Eucodis' properties or assets is subject, or (iii) result in a violation by
Eucodis of any law to which Eucodis or any of its properties or assets are
subject. There is no litigation, proceeding, investigation, arbitration or claim
pending, or, to Eucodis' knowledge, threatened against Eucodis, and there is, to
Eucodis' knowledge, no reasonable basis for any such action, which affects in
whole or in part Eucodis' ability to consummate the transactions contemplated by
this Agreement or the performance of Eucodis' obligations hereunder.
3.10. CONSENTS AND APPROVALS; TRANSFER. No permit, consent, approval or
authorization of, or declaration, filing or registration with, any Governmental
Authority or other third party is or will be necessary to be made or obtained by
Eucodis in connection with (i) the execution and delivery by Eucodis of this
Agreement, (ii) the consummation by it of the transactions contemplated under
this Agreement, or (iii) the performance by Eucodis of its obligations under
this Agreement.
4. GRANT OF LICENSING/COMMERCIALIZATION RIGHTS.
4.1. GRANT. Subject to the terms and conditions set forth in this
Agreement, MDI hereby grants Eucodis the exclusive license to develop,
manufacture and commercialize the Intellectual Property of the Product in the
Eucodis Territory for use in the Field with the right to outlicense after
completion of Phase II. The Parties agree that both the Eucodis Territory and
the Field may be expanded upon the written agreement of the Parties. MDI agrees
that prior to engaging in discussions with any other third party for a license
which would otherwise have the effect of expanding the Field in the Eucodis
Territory, MDI will notify Eucodis that such discussions will take place and
Eucodis may request within [***] of MDI's notice, that MDI engage in similar
discussions with Eucodis. This grant is limited by the description and the uses
contained within the Product's patent as filed in the Eucodis Territory. Eucodis
further acknowledges and accepts that as part of this grant of exclusive license
in for the Field in the Eucodis Territory, Eucodis is obligated to develop,
manufacture and complete all preclinical and clinical testing up to the
completion of Phase II as set forth in the Clinical Development Plan which is
attached hereto as Exhibit A, by [***]. The Parties hereto expressly acknowledge
that nothing in this grant of license, nor within the terms of this Agreement
shall have the effect of transferring ownership of the Intellectual Property
from MDI to Eucodis or any other third party.
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4.2. TERM. The grant of the license as set forth herein, shall continue
throughout the life of the Product's patent and any extensions thereto or as
long as Eucodis is under obligation to pay royalties.
4.3 IMPROVEMENTS, NEW INVENTIONS AND FIRST REFUSAL. The Parties
recognize that as a result of preclinical and clinical development, improvements
or new inventions may be discovered by one Party or the other or by a third
party contracted to perform work related to the Product. All such know how,
improvements and intellectual property which shall be the direct or indirect
result and related to the development or manufacture or commercialization of the
Product shall belong solely to MDI. Eucodis shall use commercially reasonable to
obtain all necessary executed documents from any contracted third party
acknowledging this Intellectual Property ownership right to the extent allowed
by applicable law. Eucodis shall have the exclusive license with no incremental
royalties owed and due MDI beyond that which is set forth herein, to use any
such technology, know-how or improvements for the Product, however, both Parties
shall have a paid up right to use such technology, know-how, or improvements
after the termination of this Agreement for whatever reason without any
territiorial restrictions. However during the development of the Product, the
Parties recognize that Eucodis and/or any of its subcontractors may make an
Inadvertent Discovery outside the Field of an unrelated non-oncology improvement
or new use for the Product which shall have value and meaning to both Parties.
The Parties agree that in the event of such Inadvertent Discovery, the new
invention shall be submitted to the Steering Committee for evaluation of market
value, to oversee the process of protecting the new invention through patent
filings (where applicable) and to establish a value for such Inadvertent
Discovery. MDI shall have the first opportunity to purchase Eucodis's half of
the Inadvertent Discovery at half the value established by the Steering
Committee. Eucodis will have the right to purchase MDI's half interest at the
value established by the Steering Committee if MDI does not exercise its right
to buy the Inadvertent Discovery within [***] of value being established by the
Steering Committee. The Inadvertent Discovery shall be jointly owned by the
Parties, unless either Party wishes to sell its half interest to the other at
the fair market value of the Inadvertent Discovery as determined by the Steering
Committee. However, for as long as the Inadvertent Discovery is owned jointly by
the Parties, the Parties shall share equally all costs for any patent filings
necessary to protect the Inadvertent Discovery as well as costs of preclinical
and clinical work to commercialize the Inadvertent Discovery. Eucodis shall have
an ongoing obligation to notify MDI in writing of any and all improvements, new
inventions and Inadvertent Discoveries.
4.4 DATA COLLECTION.
4.4.1 The Parties acknowledge that during the term of this
Agreement that data will be generated and collected related to the science,
method of use, and method of action of the Product. The Parties further
acknowledge that that data is proprietary to the Product and for purposes of
this Agreement shall be deemed integral to the protection of the Intellectual
Property. All data created or collected by Eucodis during the development of the
Product, shall be placed in a format and form by Eucodis which shall be
acceptable to the FDA and shall be the property of MDI subject to a license to
Eucodis for the right to use such data for purposes of this Agreement. Eucodis'
ownership of such data shall be limited to the grant of this license under this
agreement. Should the data collected by Eucodis and used by MDI for filing with
the FDA
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in the United States be deemed unacceptable to the FDA, by the FDA and require
additional work or data, such additional work or data generation and collection
(as well as testing if required by the FDA) shall be done at Eucodis' cost
provided that MDI only files for the same indications in the U.S. as Eucodis
files for in the Territory. At no time shall Eucodis be held responsible for
additional FDA costs where such costs are the result of unanticipated regulatory
changes by the FDA and which have not been published to the public prior to that
change, Should MDI learn of FDA regulatory changes it will notify Eucodis of
such changes in a timely manner however, this in no way abrogates Eucodis'
obligations hereunder. Upon the termination of this Agreement and no renewal
hereof, all such data shall be promptly returned to MDI unless otherwise agreed
to in writing by the Parties.
4.5 LICENSE REVERSION. The Parties acknowledge that time is of the
essence to the value of this License as well as the leadership of Xxxxxxxx
Xxxxxxxxxx at Eucodis. Therefore, if any of the following events occur, MDI
shall have the unilateral right to terminate this Agreement upon[***] written
notice to Eucodis which shall only be given after the expiration of the cure
period where one is provided for herein, at no cost to MDI except for paragraph
(d) in this Section 4.6 which shall subject to an immediate termination:
a) should at any point, Xxxxxxxx Xxxxxxxxxx, resign or be involuntary
removed for other reasons other than permanent disability or death from his
current role as Chief Executive Office of Eucodis before [***] whichever is
earlier; or
b) should Eucodis fail to have permission of the appropriate regulatory
bodies in the Eucodis Territory to begin clinical trials of the Product as set
forth in the Clinical Development Plan and Eucodis fails to cure this breach to
the reasonable satisfaction of MDI, within [***] after either delivery to MDI of
written notice of the breach or upon MDI's discovery of such breach and written
notice is given to Eucodis; or
c) should Eucodis fail to complete Phase II clinical trials as defined
by the Act with all data collected and evaluated in a form acceptable to EU
regulatory authorities in the Eucodis Territory and the FDA as set forth in the
Clinical Development Plan and Eucodis fails to cure this breach to the
reasonable satisfaction of MDI, within [***] after either delivery to MDI of
written notice of the breach or upon MDI's discovery of such breach and written
notice is given to Eucodis; or
d) should Eucodis suspend or discontinue its business operations or
make any assignment for the benefit of its creditors or commence voluntary
proceedings for liquidation in bankruptcy, or admit in writing its inability to
pay its debts generally as they become due, or consent to the appointment of a
receiver, trustee or liquidator of all or any part of its property, or if there
is an execution sale of a material portion of its assets or if involuntary
bankruptcy or reorganization proceedings are commenced against Eucodis or any of
its properties or if a receiver or trustee is appointed for Eucodis or any of
its properties and such proceedings are not discharged within thirty (30) days.
However, if Eucodis is unable to cure the breaches in 4.6(b) and/or(c) because
there has been a unanticipated change to the EU Directives, which had not been
published to the public prior to that change, then MDI shall still give
receive/notice as provided in those paragraphs 4.6 (b) and
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(c) but the cure period shall be extend for a reasonable period of time not to
exceed a total cure period of [***].
Should any of these events occur and MDI exercise its right to terminate this
Agreement, all rights concerning the Intellectual Property including but not
limited to, all rights to data and Inadvertent Discoveries revert back to or
become the sole property of MDI and MDI shall bear the costs of transferring the
data and the Intellectual Property hereunder and, should it to do so, assumption
of the assignment of any subcontracts hereunder.
Should the Agreement terminate under 4.6(b) and/or (c) above due to a failure of
Eucodis which was caused by the reasons out of its reasonable control, MDI and
Eucodis will in good faith negotiate what reasonable costs are reimbursable to
Eucodis.
Should MDI suspend or discontinue its business operations or make any assignment
for the benefit of its creditors or commence voluntary proceedings for
liquidation in bankruptcy, or admit in writing its inability to pay its debts
generally as they become due, or consent to the appointment of a receiver,
trustee or liquidator of its property obtained from the Bankrupt Company, or if
there is an execution sale of a material portion of its assets purchased from
the Bankrupt Company or if involuntary bankruptcy or reorganization proceedings
are commenced against MDI or if a receiver or trustee is appointed for MDI or
any of its properties purchased from the Bankrupt Company and such proceedings
are not discharged within thirty days, Eucodis will have the right to terminate
this Agreement and if termination occurs, Eucodis shall, in addition to the
rights set forth in 15.2 ( c ) below, have the right, as directed by the
liquidator, trustee or receiver, to purchase the Intellectual Property known as
the Product for fair market value.
5. OUT LICENSING.
5.1 ROYALTIES. In the event that Phase II clinical trials are completed
and the Product is out licensed to a third party for any indication in the Field
for the Eucodis Territory, Eucodis shall pay royalties to MDI the percentage of
Net Revenues received by Eucodis from a third party outlicense as set in 5.1.1
herein. MDI will be paid by Eucodis its percentage of Net Revenue in United
States dollars. When Net Revenue is paid to Eucodis in Currency other than
United States dollars, the rate of exchange to be used for converting such other
currency into United States dollars shall be at the exchange rates stated in the
Wall Street Journal on the date that payment is received by Eucodis. All costs
to convert the currency into United States dollars will belong to Eucodis. The
amount payable to MDI is due to MDI [***] after the month ending in which the
payment was received by Eucodis. Any tax paid or required to be withheld by
Eucodis for the benefit of MDI on any payments payable to MDI under this
Agreement shall be deducted from the amount of payments otherwise due MDI. No
outlicense shall be for longer than the term of this Agreement and at the end of
that out license all rights remaining in the Intellectual Property, data of any
kind related to the Intellectual Property and any other information about the
market for the Intellectual Property must revert back to MDI unless otherwise
agreed to, in writing, by MDI. For purposes of this section 5 of this Agreement,
the Product shall be deemed to remain in Phase II until the following three
events have all occurred: i) the Steering Committee has agreed on a Phase III
clinical trial plan and cost estimate attendant
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thereto; ii) both Eucodis and MDI have secured funding for [***] each of the
costs of Phase III; and iii) the appropriate regulatory bodies have approved the
Phase III Clinical Trial protocol and have consented to entry into the clinic to
commence Phase III Clinical Trials.
5.1.1 Should Eucodis negotiate an out license for the Eucodis
Territory at the end of Phase II, the Parties agree that the royalty payments
and any upfront payments received from the outlicensor shall be paid as set
forth in this paragraph 5.1.1.
Net Revenue Received by Cumulative Net Revenue
Eucodis from Third Party Received by Eucodis % of Net
Out-License in EU Market from Third Party Revenue % of Net Revenue Eucodis Net Cash MDI Royalty Payment
Out-License in EU Retained by Paid to MDI as after Payment of MDI
Market Eucodis Royalty Royalty
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[***] [***] [***] [***] [***] [***]
5.1.2 Should the Steering Committee decide to move forward
with a Phase III Clinical Trial the cost of the Phase III Clinical Trial shall
be borne by the Parties on a [***] . Should Eucodis negotiate an out license for
the Eucodis Territory at the end of Phase III, the Parties agree that the
royalty payments and any upfront payments received from the outlicensor shall be
paid as set forth in this paragraph 5.1.2. In the event of no third party
license, any and all drafting and filing costs incurred in preparing the
documents to be filed with the E.U. Governmental Authorities seeking approval to
market shall be borne [***].
Cumulative Net % of Net
Net Revenue Net Revenue Revenue Received Revenue
Received by Eucodis Received by by Eucodis from % of Net Paid to
from Third Party Eucodis from Third Party Revenue MDI as Eucodis Net Cash
Out-License in EU Third Party Out-License in EU Retained Royalty after Payment of
Market Out-License in Market by Eucodis MDI Royalty MDI Royalty Payment
EU Market
--------------------------------------------------------------------------------------------------------------------------
[***] [***] [***] [***] [***] [***] [***]
5.1.3 Should the Parties agree to allow Eucodis to commercialize the
Product before such commercialization occurs, the Steering Committee must meet
and agree that
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commercialization is feasible within the EU Territory as expanded in Exhibit D
attached hereto and made part of this Agreement, and that Eucodis has the
resources and ability to commercialize the Product. The Parties agree to
negotiate in good faith the terms of the commercialization but in no event shall
the monetary terms of the commercialization fail to adequately reimburse the
Parties for each of the Parties Phase III clinical trial costs. If the
management teams of each of the Parties cannot reach agreement on the
commercialization terms within a commercially reasonable time then the
commercialization issues and any and all terms agreed upon and at issue shall be
turned over to the Chief Executive Officers of each of the Parties who shall
then have [***] from the date of receipt to reach agreement. If the Chief
Executive Officers cannot reach agreement within the [***], the Parties shall
name a mutually agreed upon mediator within [***] and if the Parties cannot
agree on a mediator then each side shall name a mediator which shall jointly
mediate to resolution. If only one mediator is used, the Parties shall share the
cost of such mediator and if two mediators must be named then each Party shall
bear the cost of its named mediator. Mediation shall take place in the United
States. Any terms and conditions of commercialization regardless of how
agreement on such terms and conditions are reached, must be acceptable to MDI
and their consent to those terms cannot be unreasonably withheld
5.2 APPROVAL. MDI shall have the final right of approval on any out
licensing deal, such approval shall not be unreasonably withheld. Under no
circumstance shall Eucodis consider or enter into discussion concerning an out
licensing deal prior to the completion of Phase II clinical trials without the
prior written consent of MDI. Eucodis agrees to inform MDI immediately of any
outlicense deal it is contemplating and the terms thereof prior to engaging in
negotiations. No letters of intent or any other binding or nonbinding documents
shall be executed by Eucodis related to an outlicense for the Product in the
Eucodis Territory without first providing a copy of such document to MDI and MDI
having an opportunity to comment thereon.
5.3 GLOBAL LICENSE. The grant of the license as set forth in this
Agreement, to Eucodis is subordinate to MDI's ability to execute a global
license deal which would include the Eucodis Territory. MDI shall control and
lead all global licensing negotiations and Eucodis shall have the right to be
reasonably involved in the process. Eucodis expressly agrees that should it be
approached by a third party interested in a global license that such third party
must be referred to MDI immediately. MDI expressly agrees that should it be
approached by a third party interested in a global license, MDI will immediately
inform Eucodis. If MDI executes a global license Eucodis shall be entitled to
[***].
5.4 AUDIT RIGHTS. MDI has the right to ask for an audit of all costs
incurred by Eucodis in Phase II, and/or royalties and any other payments made to
Eucodis by the licensor of any out license contemplated hereunder. Eucodis will
grant an independent certified public accountant, selected by MDI and reasonably
acceptable to Eucodis which acceptance shall not be unreasonably withheld,
access to all Eucodis books and records relevant to this Agreement necessary to
verify the accuracy of reports provided, royalties paid and costs incurred under
this Agreement. MDI must provide at least [***] written notice to Eucodis prior
to the commencement of the audit and may not audit Eucodis more than [***]
without good cause. The audit shall initially be at MDI's expense, however,
should the audit reveal that monies are
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owed MDI, as a result of this audit, then Eucodis must pay those monies within
[***] plus [***] interest from the time the monies were originally due. If an
inaccuracy in the payments to MDI is greater than [***], Eucodis shall pay the
cost of the audit.
5.5 TERMINATION. The duration of the Agreement and therefore the
payment obligations of Eucodis shall last until the expiration of the last
relevant Product patent in the Eucodis Territiory and for [***] thereafter if
MDI's Intellectual Property is [***], or unless otherwise terminated under the
termination provisions contained in Section 16 of the Agreement. Nothing here
shall be deemed to limit the Parties rights to negotiate a subsequent license
and marketing agreement for the Territory once this Agreement terminates.
6. OWNERSHIP; TRADEMARKS; PROPRIETARY INFORMATION.
6.1 OWNERSHIP. Any trademarks, trade names, brand names, patents,
slogans, logos, copyrights, trade dress, know-how and goodwill associated with
the Product shall be the sole and exclusive property of MDI, including but not
limited to any improvements or modifications to this property for the Product in
the Field and shall be held in confidence by Eucodis for MDI's sole benefit in
the development and/or the operation of manufacturing processes with respect to
the Product. Eucodis shall disclose to MDI and receive the approval of MDI with
respect to all such improvements or modifications relating to the manufacturing,
and/or packaging process of the Product or use of the Products developed by
Eucodis. Eucodis shall have no right or license to use any such rights at any
time before, during or after the Term of this Agreement, except as necessary for
the manufacture, processing, packaging and supply of Product to MDI hereunder.
(a) It is agreed that MDI is the sole owner of any and all
Specifications supplied or paid for by MDI, and Eucodis shall not use any such
Specifications except in connection with its performance under this Agreement.
(b) The provisions of this Section 6.1 shall survive the termination or
expiration of this Agreement.
(c) The parties agree that they shall jointly own all preclinical and
clinical trial documents, any and all documents filed with the E.U. regulatory
approval boards, and all marketing materials developed by Eucodis for the
Product in the Field for use in the Eucodis Territory. However, Eucodis agrees
that all such documents listed herein shall only be used for those purposes set
forth herein.
6.2 ASSIGNMENT OF RIGHTS. MDI shall use commercially reasonable efforts
to continue to pursue the assignment of the patent rights in the Product to the
extent such assignment has not yet been effectuated in the Eucodis Territory.
6.3 INFORMATION SHARING. Each Party shall promptly share with the other
Party any additional information it gains relating to the Intellectual Property.
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7. CONFIDENTIALITY The terms and conditions of this Agreement (but not its
existence) are Confidential Information that shall not be disclosed to third
parties without the written consent of MDI and Eucodis with the exception of any
regulatory filings, press releases as set forth in Section 18.11, or disclosures
to investors that the Parties may be required to make under either US, EU or any
other relevant countries' laws and regulations.
7.1 Access to Confidential Information shall be limited to the
respective employees and consultants of the Parties and their counsel unless a
confidentiality and nondisclosure agreement is executed by any third party prior
to such disclosure.
7.2 This Confidential Information is to be used for the sole purpose of
carrying out the purposes of this Agreement.
7.3 The Party disclosing the Confidential Information shall use it best
efforts to ensure that the recipient of the Confidential Information shall not
disclose it to any other individual entity, or cause or allow such Confidential
Information to be disclosed, except that he or she may discuss the Confidential
Information with other employees, consultants, or attorneys who have been
identified the Parties as necessary to receive it.
7.4 To the extent that a nonparty is provided documents which contain
or are Confidential Information by a Party for purposes of developing,
manufacturing or the running of clinical trials, such documents are not to be
photocopied, scanned or reproduced in any other way, and are to be returned to
the Disclosing Party upon its request, with the exception of permissible
reproduction for a single archival copy to be maintained as Confidential
Information by the Receiving Party if such Receiving Party is either a Party
hereto or is required by the Act or other relevant laws and regulations to
retain a copy.
7.5 Neither Party will assert that anything disclosed or discussed
constitutes a waiver of attorney-client privilege or attorney work-product.
7.6 This Agreement shall not apply to: (i) information produced or
disclosed in discovery in subsequent litigation between the parties, should that
materialize, (ii) information which now or hereafter becomes generally known or
available to the public without Receiving Party's breach of any obligation owed
to the Disclosing Party, or (iii) information which was in the possession of the
Receiving Party prior to execution of this Agreement and which was not
previously obtained by the Receiving Party from the Disclosing Party, and is so
documented by the Receiving Party prior to the date of this Agreement, or (iv)
information that comes into possession of the Receiving Party after execution of
this Agreement from a third party having legal right to disclose such
information, or (v) information that is independently developed by or for the
Receiving Party without aid or reference to the disclosed Confidential
Information of the Disclosing Party; or (vi) information that is disclosed in a
press release agreed to by both Parties, or information that Parties otherwise
agreed in writing to publish. Provided however, that disclosure of information
otherwise the subject of this Agreement that is provided to customers and
potential customers, in furtherance of the purpose of this Agreement or other
agreements between the parties, shall not be considered to remove such
Confidential Information from the subject matter of this Agreement.
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7.7 If a party breaches any of its obligations with respect to
confidential and unauthorized use of Confidential Information hereunder, the
non-breaching party shall be entitled to equitable relief to protect its
interest therein, including but not limited to injunctive relief, as well as
money damages notwithstanding anything to the contrary contained herein.
8. DEVELOPMENT AND CLINICAL WORK.
8.1 CO-DEVELOPMENT LICENSE. Integral to this license is an obligation
of Eucodis to develop the Product for the EU while capturing data in a form
which will be acceptable to the FDA. Such license shall include, but is not
limited to, specific and articulated rights as to the development of the
Product, the completion of all necessary preclinical and clinical work through
Phase II clinical trials as defined by the Act, payment for and the acquisition
of all CMC data performed prior to MDI's purchase of the Product as per Section
8.2 below, and entry into the clinic for purposes of performing clinical trials.
8.2 DATA COLLECTION. The Parties hereto acknowledge that there are
certain companies which currently possess necessary Product data including, but
not limited to, data constituting the Drug Master File as defined within the
Act, reports of studies with supporting data already completed and stability
data which Eucodis should obtain. The Parties further acknowledge that this
prior work resulting in this information was included in MDI's asset purchase
from the Bankrupt Company and that outstanding unpaid bills have caused such
data and information to be held by those companies owed money by the estate of
the Bankrupt Company. Eucodis shall pay up to [***], from its own finances with
no back charge to MDI in order to obtain the data referred to in herein. Should
either Eucodis or MDI discover that there is additional necessary scientific
data which was commissioned by the Bankrupt Company for which funds in excess of
[***] are needed, then the Chief Executive Officers of each of the parties shall
meet to determine whether to incur the expense and how to apportion the cost. If
the Chief Executive Officers cannot agree on the need for the expenditure, then
they may submit it to the Steering Committee for resolution.
8.3 PROTOCOLS. Any and all preclinical and clinical trial protocols
used by Eucodis for purposes of obtaining EU drug approval, must meet the FDA
guidelines for acceptance of clinical data from trials performed outside of the
United States. Eucodis shall provide copies of all such protocols to MDI upon
completion of the drafting of the protocols prior to commencement of the
clinical trials pursuant to those protocols.
8.4 RIGHT TO AUDIT THE DATA. In accordance with the applicable privacy
regulations, each Party shall have the right, throughout the term of this
Agreement, to audit any and all preclinical and clinical trial work being
performed, either directly or indirectly related to the Intellectual Property.
The audit shall be at the expense of the auditing Party. Should the auditing
Party learn, as a result of the audit, discrepancies or errors in data
collection or compliance with regulations under the Act, then the auditing Party
shall notify the other Party in writing of these discrepancies and or errors and
the nonAuditing Party shall correct these discrepancies and errors at its own
costs. Nothing herein shall be deemed a waiver of Eucodis obligation hereunder
to supply data which is acceptable to the FDA and meets the requirements as set
forth in the Act
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and the ensuing regulations. If MDI does not inform Eucodis on any discrepancies
and/or errors, it is understood that data are acceptable and meet the
requirements of FDA and Eucodis shall not be liable for any cost of eventual
later action or studies required by FDA.
9. MANUFACTURING .
9.1 EXCLUSIVE RIGHT. Integral to the exclusive license hereunder,
Eucodis shall be solely responsible for the manufacture the Product for the
Eucodis Territory while ensuring that there is sufficient supply for all stages
of preclinical and clinical development in accordance with the clinical
Development Plan for the concurrent development in the United States. Eucodis
shall enter in to an agreement with a contract manufacturer which meets all FDA
cGMP requirements and the corollary EU requirements. Eucodis shall not select a
contract manufacturer which has failed and FDA site inspection, which is
incapable of passing such FDA site inspection and which cannot manufacture per
Product specifications, meet storage requirements, perform quality tests and
checks. Eucodis shall notify MDI when it enters into such an agreement and shall
ensure the integrity of all MDI's Intellectual Property, proprietary business
information and the non disclosure thereof. Eucodis shall have the
responsibility for managing the contract manufacturer including the protection
of the Product as an MDI asset. Eucodis shall be responsible for working with
the manufacturer in collecting and ensuring that all API and Batch as those
terms are defined in the Act and other manufacturing records for the European
Union comply with all FDA and EU requirements.
9.2 PURCHASE AND INSTALLATION OF EQUIPMENT. The installation,
qualification and maintenance of all equipment at the manufacturing Facility
shall be conducted in accordance with all applicable laws, rules and regulations
and any relevant specifications.
9.3 PURCHASE OF LABELS AND PACKAGING. Eucodis shall develop all label
and packaging specifications ensuring that such labels and packaging comport
with the applicable EU requirements which are necessary for transporting the
Product to the preclinical or clinical sites.
9.4 AGREEMENT TO SUPPLY. During preclinical and clinical development of
the Product MDI will purchase its Product from Eucodis. MDI shall be entitled to
a discount off purchase price as set forth herein. Subject to the terms and
conditions of this Agreement, MDI shall be able to obtain the Product produced
under Agreement at Eucodis'cost plus [***]. Cost plus [***] shall not include
any shipping, administrative costs or handling costs incurred by either Eucodis
or the contract manufacturer. The sum of cost plus [***] shall be determined by
the Eucodis invoice from the contract manufacturer to Eucodis plus [***] and a
copy of such invoice must be attached to the Eucodis invoice to MDI for the
Product requested by MDI.
9.5 REQUIRED TOLERANCE. Eucodis shall ensure that the Product is
manufactured and packaged pursuant to the Product Specifications and as required
by the applicable Governmental Authorities.
9.6 QUANTITATIVE AND QUALITATIVE DEFECTS. MDI shall be informed by
Eucodis in writing of any claims relating to quantitative and qualitative
defects in the manufacture of the Product within [***] following actual receipt
of such claims. If the claims call into question the
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safety of the Product then Eucodis must immediately notify MDI and an
investigation must be undertaken within [***] and completed in [***]. A written
report shall be prepared by Eucodis and given to MDI. Within this[***], Eucodis
must conduct an investigation of any such claims and notify MDI in writing of
the outcome of this investigation. In the event that the defect is a
quantitative defect related to Product requested by MDI, Eucodis shall provide
MDI with any missing quantities of such Product as soon as reasonably possible
after receipt of notice from MDI. MDI shall only be obligated to pay for actual
quantities of Product received by MDI.
9.7 INVENTORY . Eucodis will keep adequate inventories of Product
materials on hand or with suppliers according to the Clinical Development Plan
and any quantities in inventory which comply with the requirements of the Act.
9.8 PRODUCT FOR CLINICAL TRIALS. Eucodis shall ensure that there is a
sufficient supply of the Product according to the Development Plan for use in
both the EU and the United States clinical trials and for sampling should MDI
require such samples.
9.9 INSPECTIONS AND AUDITS. MDI shall have reasonable access to the
manufacturing Facility for the purpose of conducting inspections, performing
quality control audits or witnessing the processing, storage or transportation
of Product or materials related to or used in the manufacture or packaging of
Product, and MDI shall have access to the results of any Product tests performed
by the contract manufacturer. MDI shall also be permitted to audit the
manufacturing batch records to the extent reasonably necessary to verify
compliance with applicable Act requirements and this Agreement.
9.10 GOVERNMENT INSPECTIONS, SEIZURES AND RECALLS. If the FDA or any
other federal, state or local governmental authority or EU authority makes an
inspection at the contract manufacturer's Facility which involves any Product,
or seizes Product or requests a recall of Product, Eucodis shall promptly send
retained samples of Products seized by such authority and duplicate reports
relating to such inspections and send a copy to MDI. Eucodis shall be
responsible for interacting with the EU regulators to cure any issues created by
the inspection, seizure or recall and shall assist MDI in curing any issues with
the FDA which are the result of the inspection, seizure and recall.
9.11 LEGAL AND REGULATORY FILINGS AND REQUESTS. Eucodis and MDI shall
cooperate and be diligent in responding to all requests for information from,
and in making all required filings with, regulatory authorities having
jurisdiction to make such requests or require such filings. Eucodis shall obtain
and comply with all licenses, consents, permits and regulations which may from
time to time be required by appropriate legal and regulatory authorities with
respect to the performance of its obligations hereunder.
9.12 GENERAL REPRESENTATIONS AND WARRANTIES. Eucodis hereby represents,
warrants and covenants to MDI that the Product furnished by Eucodis through the
contract manufacturer: (i) shall be of the quality specified in, and shall
conform with, the Specifications, and (ii) shall be manufactured, processed,
packaged, stored and delivered in conformity with the Specifications and all
applicable laws, rules and regulations including current good manufacturing
practices. In addition, Eucodis warrants to MDI that Eucodis has not and will
not use any materials that would
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cause the Product to be adulterated within the meaning of Section 501 of the
Act, as amended from time to time, and further, the Product shall not be
misbranded within the meaning of the Act. Any other representations or
warranties relate to Manufacturing and not expressly made in this Agreement,
including, but not limited to paragraphs 9 and 10, of this Agreement, are deemed
by the Parties as not having been made or to the extent permissible by the Act
are expressly disclaimed.
9.13 NOTICE OF MATERIAL EVENTS. Eucodis hereby agrees to notify MDI
promptly of any actual or anticipated events which are reasonably likely to have
a material adverse effect on the Product or on Eucodis ability to produce
Product in accordance with the provisions set forth herein.
10. PAYMENT AND SHIPPING OF PRODUCT TO MDI
10.1 SHIPPING INSTRUCTIONS; RISK OF LOSS. MDI shall, should it choose
to order Product, specify the mode of shipment, the carrier and shall bear the
cost of the shipment. Eucodis will schedule all such shipping and be responsible
for ensuring that the attendant and necessary documentation is complete for ease
of entry into the US stream of commerce or any countries' stream of commerce as
designated by MDI. The Product shall be delivered [***].
10.2 INVOICES; QUANTITIES. Eucodis shall submit invoices to MDI for all
shipments of Product hereunder upon shipment of such Product to MDI. (which
invoices shall be directed by Eucodis to MDI, Accounts Payable, 0000 X. Xxxxxxxx
Xxxxx, #000, Xxxx Xxxx Xxxx, Xxxx 00000, or to such other persons, departments
or locations as MDI may instruct from time to time), and such invoices shall be
payable within [***] from issuance.
11. CONSIDERATION.
11.1 FEE. Eucodis shall pay to MDI an upfront fee of [***] payable as
follows: [***]
These payments are exclusive of any payments set forth in Section 6 herein.
11.2 MILESTONE PAYMENTS. Milestone payments shall be made at set
performance and date targets. [***]
11.3 RECOVERY OF COSTS. In the event MDI is unable to secure an order
form the German court where the litigation concerning the ownership of the
Product's patent is pending, by the end of the Phase II clinical trials and the
Parties have not identified a licensor in the EU and the Parties both agree not
to move forward with a Phase III clinical trial in the Eucodis Territory, or six
months after the completion of Phase III should the Parties have agreed to move
forward with these Phase III clinical trials, then MDI shall grant to Eucodis
[***] of MDI Net Revenues on the Product in the US market capped at $8.3 million
US dollars. Once Eucodis has received this amount in payment, then Eucodis shall
continue to receive [***] of the US market Net Revenues up to an including an
additional[***]. However the entire amount of [***] provided for under this
paragraph 12.3 must be paid within [***] of the date of the first dollar of
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Net Revenue is received by MDI from the US market. Should MDI fail to pursue the
United States market itself or otherwise obtain a license from a third party for
the US market, then MDI shall provide written notice of its nonpursuit to
Eucodis and Eucodis shall then be given the right, subject to the global license
provisions herein, to pursue and develop the US market. Any Net Revenues
received by Eucodis as a result of this US market development shall belong
solely to Eucodis until such time that Eucodis has received [***] from the US
market. Thereafter Eucodis' license to the US market shall revert to MDI
however, Eucodis shall be entitled to [***] of the Net Revenues of the US market
for period of [***] after the license reversion to MDI.
11.3.1 In addition, should the events set forth in 11.3 herein
occur, the Agreement shall terminate with all Intellectual Property, related
data and other rights reverting back to MDI.
11.3.2 Eucodis agrees that at any time MDI may ask for an
accounting of Eucodis' costs which shall be done by Eucodis in accordance with
US GAAP. Should Parties enter into Phase III clinical trials, this right to
audit becomes reciprocal.
12. STEERING COMMITTEE. MDI and Eucodis shall form a Steering Committee of five
(5) members. Each Party shall name two individuals to the Steering Committee of
their own choosing and the fifth member shall be mutually agreeable to both
Parties. Each Party shall bear the cost of the two members it each names and the
cost of the fifth member will be shared equally between the Parties. The fifth
member shall serve a term of one year which the Parties can unanimously agree to
extend to additional one year terms. The Steering Committee shall meet once a
quarter and shall address any and all development and manufacturing issues which
arise during the term of the Agreement.. The Steering Committee shall have the
authority to generally guide, plan , monitor and, if needed, direct the Clinical
Development Plan, settle disagreements between the Parties, monitoring the
patent filing strategy in the Territory.
13. INDEMNIFICATION
13.1 EUCODIS INDEMNIFICATION OF MDI. Eucodis shall indemnify, defend
and hold MDI, each Affiliate of MDI and the officers, employees, and agents
thereof (each an "MDI indemnified party") harmless from and against any and all
losses, liabilities, damages, claims, expenses, suits, recoveries, judgments and
fines (including reasonable attorneys' fees and expenses) (collectively,
"Losses") that may be incurred by any MDI indemnified party arising out of any
(i) damage to property or injury or death occurring to any person arising out of
possession, use or consumption by any person of the Product to the extent that
such damage, injury or death was caused by the failure of such Product to meet
Specifications, including the contamination or adulteration of the Product while
in the control of Eucodis; (ii) injury to person or property or death occurring
to any Eucodis employees, subcontractors, agents or any individuals on Eucodis's
premises; (iii) claim, action or proceeding brought by any governmental or
regulatory authority arising out of or resulting from any manufacture, packaging
or supply of Product by Eucodis which is not in accordance with this Agreement;
(iv) breach by Eucodis of any of its obligations, representations or warranties
under this Agreement, including a breach which results in a Recall of Product to
the extent that Eucodis is responsible for such Recall
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under Section 11.7, or (v) any other willfully negligent or wanton act of
omission or commission on the part of Eucodis.
13.2 MDI'S INDEMNIFICATION OF EUCODIS. MDI shall indemnify, defend and
hold Eucodis, each Affiliate of Eucodis and the officers, directors and
employees thereof (each a "Eucodis indemnified party") harmless from and against
any and all Losses that may be incurred by any Eucodis indemnified party arising
out of any (i) damage to property or injury or death occurring to any person
arising out of possession, use or consumption by any person of the Product to
the extent that such damage, injury or death was caused by the contamination or
adulteration of the Product while in the control of MDI or by any defective
Specification furnished by MDI or (ii) injury to person or property or death
occurring to any MDI employees, subcontractors, agents or any individuals on
MDIs's premises or caused by the presence of MDI's employees or agents at the
Facility; (iii) claim that the manufacture of the Product by Eucodis under this
Agreement infringes the intellectual property rights of any other Person by
reason of the use of any intellectual property rights owned by MDI; (iv) breach
by MDI of any of its obligations, representations or warranties under this
Agreement, including a breach which results in a Recall of Product or (v) any
other willfully negligent or wanton act of omission or commission on the part of
MDI.
13.3 PROCEDURES. Any Person that may be entitled to indemnification
under this Agreement (an "Indemnified Party") shall give written notice to the
Person obligated to indemnify it (an "Indemnifying Party") with reasonable
promptness upon becoming aware of any claim or other facts upon which a claim
for indemnification will or is reasonably likely to be based; the notice shall
set forth such information with respect thereto as is then reasonably available
to the Indemnified Party. The Indemnifying Party shall have the right to
undertake the defense of any such claim asserted by a third party with counsel
reasonably satisfactory to the Indemnified Party and the Indemnified Party shall
cooperate in such defense and make available all records, materials and
witnesses reasonably requested by the Indemnifying Party in connection therewith
at the Indemnifying Party's expense. If the Indemnifying Party shall have
assumed the defense of the claim with counsel reasonably satisfactory to the
Indemnified Party, the Indemnifying Party shall not be liable to the Indemnified
Party for any legal or other expenses (other than for reasonable costs of
investigation) subsequently incurred by the Indemnified Party in connection with
the defense thereof. The Indemnifying Party shall not be liable for any claim
settled without its consent, which consent shall not be unreasonably withheld or
delayed. The Indemnifying Party shall obtain the written consent of the
Indemnified Party prior to ceasing to defend, settling or otherwise disposing of
any claim. In no event shall the indemnifying Party without notice to the other
Party, institute, settle or otherwise resolve any claim or potential claim,
action or proceeding.
13.4 SURVIVAL. The indemnification obligations set forth in this
Section 16 shall survive the expiration or termination of this Agreement.
14. RELATIONSHIP OF THE PARTIES.
The relationship between MDI and Eucodis is that of independent
contractors and nothing herein shall be deemed to constitute the relationship of
partners, joint venturers, nor of
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principal and agent between MDI and Eucodis. 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. Except as otherwise
contemplated or permitted by the Agreement, all persons employed by Eucodis in
connection with the manufacturing, packaging and supply of the Product to MDI
shall be employees or agents of Eucodis and under no circumstances shall Eucodis
or any of its employees or agents be deemed to be employees or agents of MDI.
15. TERM; TERMINATION.
15.1 INITIAL TERM; TERM. Agreement is effective upon execution and its
initial term shall commence on the 28th day of July, 2006 and shall continue as
set forth in Paragraph 4.2 of this Agreement. After the Initial Term, the
Parties may renew this Agreement for continuous additional Renewal Term(s) of
one (1) year unless either Party shall have given written notice of termination
to the other Party not less than six (6) months prior to the expiration of the
Initial Term, or any Renewal Term.
15.2 TERMINATION. (a) Either Party may terminate this Agreement at any
time during the Term by written notice to the other Party if:
(i) the other Party shall suspend or discontinue its business
operations or make any assignment for the benefit of its creditors or commence
voluntary proceedings for liquidation in bankruptcy, or admit in writing its
inability to pay its debts generally as they become due, or consent to the
appointment of a receiver, trustee or liquidator of the other Party or of all or
any part of its property, or if there is an execution sale of a material portion
of its assets;
(ii) involuntary bankruptcy or reorganization proceedings are
commenced against the other party or any of its properties or if a receiver or
trustee is appointed for the other Party or any of its properties and such
proceedings are not discharged within [***];
(iii) the other Party files or consents to the filing of a
petition for reorganization or arrangement under any applicable bankruptcy law;
or
(iv) the other Party fails to comply with any material term of
this Agreement or breaches any representation or warranty herein and fails to
cure such noncompliance or breaches expressly provided for herein or within
[***] (or within [***] in the case of a payment default). Should either Party's
failure to cure continue for a period of more than [***] (or within [***] in the
case of a payment default), the nonbreaching Party may suspend or terminate its
services or obligations under this Agreement without being in breach or default
of its obligations hereunder.
(b) Termination of this Agreement, however, shall not affect any
obligation to pay money, indemnify, reimburse, maintain confidentiality or
otherwise which either Party hereto may have incurred during the Term hereof.
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(c) Should this Agreement be terminated due to the reasons set forth in
Section 15.2 (i), (ii) or(iii) on MDI's side, Eucodis shall have the exclusive,
fully paid-up license to continue to develop, manufacture and commercialize the
Intellectual Property of the Product in the Eucodis Territory for use in the
Field with the right to outlicense after completion of Phase II, without
financial obligation to MDI.
16. FORCE MAJEURE.
Performance under this Agreement (other than payments required to be
made by either Party) shall be excused to the extent prevented or delayed by
fire, flood, explosion, unavoidable widespread product tampering by third
parties, war, shortages or unavailability of materials, any act of God, or by
any other similar circumstances of any character reasonably beyond the control
of the party so excused. The Party affected shall promptly notify in writing the
non-affected Party of the event of force majeure and the probable duration of
the delay. Any delay caused by an event of force majeure shall toll the term of
this Agreement which shall be extended by the length thereof. In the event a
force majeure prevents performance by one party for more than [***], the other
Party shall have the right to terminate this Agreement.
17. MISCELLANEOUS.
17.1 NOTICE. All notices, requests, demands or other communications to
or upon the respective Parties hereto shall be deemed to have been given or made
when deposited in the mails, registered mail or certified, return receipt
requested, postage prepaid, or overnight courier or by facsimile transmission,
the receipt of which is confirmed by telephone, addressed to the respective
party at the following address (or to such other person or address as is
specified elsewhere in this Agreement for specific purposes):
If to EUCODIS:
Eucodis Forschungs -- und Entwicklungs GmbH
Xxxxxxx Xxx. 00, 0000
0000, Xxxxxx, Xxxxxxx
Attention: Xxxxxxxx Xxxxxxxxxx, M.D.
If to MDI: MDI Oncology, Inc.
0000 X. Xxxxxxxx Xxxxx # 000
Xxxx Xxxx Xxxx, Xxxx 00000
Attention: Xxxx X. Xxxxxxxx
With a copy to: Xxxxxxx Xxxxxx & Green, P.C.
000 X. Xxxxxxxx Xxxxxx, 00xx Xxxxx
Xxxxxxx, XX 00000
Attention: Xxxxx Xxxxx-Xxxx, Esq.
Facsimile Number: 000-000-0000
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The above addresses for receipt of notice may be changed by either
Party by notice, given as provided herein.
18.2. ENTIRE AGREEMENT. This Agreement contains the entire
understanding of the Parties, superseding in all respects any and all prior oral
or written agreements or understandings pertaining to the subject matter hereof.
This Agreement can be amended, modified or supplemented only by an agreement in
writing which is signed by all the Parties hereto.
18.3. INCORPORATION OF EXHIBITS AND SCHEDULES. The Exhibits and
Schedules attached to this Agreement are incorporated herein and are hereby made
a part of this Agreement.
18.4. SEVERABILITY. If and to the extent that any court of competent
jurisdiction holds any provision or part of this Agreement to be invalid or
unenforceable, such holding shall in no way affect the validity of the remainder
of this Agreement.
18.5 SUCCESSORS AND ASSIGNS. This Agreement shall inure to the benefit
of and be binding upon the successors and permitted assigns of the Parties;
provided, however, that if at any time during the Term of this Agreement Eucodis
is acquired by or becomes an affiliated company of a competitor of MDI having a
competitive product in the Field, then MDI may terminate this Agreement at any
time upon not less than [***] written notice, provided, further, that promptly
upon such termination, MDI shall compensate Eucodis for any uncancellable
obligations and all in-process material costs and finished Product.
18.6 ASSIGNMENT. Neither Party shall, without the prior written consent
of the other Party, delegate, transfer, convey, assign or pledge any of its
rights or obligations under this Agreement to any other person, firm or
corporation, except that (i) MDI may assign this Agreement, in whole or in part,
with respect to any Product which business is sold, transferred or assigned to a
third party without the prior written consent of Eucodis and (ii) either Party
may assign this Agreement, including all of its rights and obligations
hereunder, to any Person or any Affiliate of such Person in connection with a
transaction whereby such Person or any Affiliate of such Person acquires control
of such party. Any assignee, whether consent to such assignee has been granted
or whether no such consent is required under the terms of this Agreement, must
agree to be bound by the obligations and duties of the assigning Party as set
forth in this Agreement. Should any right, title, or interest in the ownership
or sale of the Product change, this Agreement is intended to bind all
successor(s) in interest to the assigning company as same relates to the
Product. Prior to the change, modification, or transfer of any such right, title
or interest in the Product, the assigning company shall notify all such
successor(s) in interest in writing that such successor(s) will be bound by this
Agreement.
18.7. WAIVER. A waiver by either party of any of the terms and
conditions of this Agreement in any instance shall not be deemed or construed to
be a waiver of such term or condition for the future.
18.8. HEADINGS. Headings in this Agreement are included for ease of
reference only and have no legal effect.
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18.9. COUNTERPARTS. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original and all of which
together shall constitute one and the same instrument.
18.10. APPLICABLE LAW. This Agreement is governed by and shall be
construed in accordance with the laws of the State of Utah , United States of
America, regardless of any conflicts of laws provisions. Any disputes under this
Agreement shall be subject to arbitration under the Rules of Arbitration of the
International Chamber of Commerce. The arbitration shall take place in Frankfurt
Germany with three arbitrators two of which must have significant experience in
the biotech/pharmaceutical licensing area. The language of the arbitration
proceedings shall be conducted in English.
18.11. PRESS RELEASE. The Parties shall have the right to issue press
releases relating to its entry into this Agreement and the reporting of any and
all progress made in the development of the Product in the Field for the Eucodis
Territory, provided that prior to release, the releasing Party provides the
other Party with a draft of the press release in sufficient time for the
nonreleasing Party to comment on the release. At no time shall Eucodis issue a
release which places MDI at risk with any Governmental Authority as such relates
to its public company position.
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In Witness Whereof, the parties have caused this Agreement to be duly
executed in their respective names and on their behalf, as of the date first
above written.
EUCODIS FORSCHUNGS-UND
ENTWICKLUNGS GmbH
By: /s/ Xxxxxxxx Xxxxxxxxx
--------------------------------
Title: CEO
MDI ONCOLOGY, INC.
By: /s/ Xxxx X. Xxxxxxxx
--------------------------------
Title: CEO
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EXHIBIT A
CLINICAL DEVELOPMENT PLAN
[***]
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EXHIBIT B
EU MARKET DATA SUPPLIED BY EUCODIS
[***]
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EXHIBIT C
WORK COMMISSIONED BY THE BANKRUPT COMPANY AND OBTAINED BY EUCODIS
[***]
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EXHIBIT D
THE COUNTRIES INCLUDED IN EUCODIS TERRITORY, IN ADDITION TO THE
TERRITORY COVERED IN 1.8
[***]
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