AMENDED AND RESTATED LICENSE AGREEMENT
EXHIBIT
99.4
CONFIDENTIAL
AMENDED
AND RESTATED
by and
between
Max-Xxxxxx-Innovation
GmbH
a German
corporation having a principal place of business at
Xxxxxxxxxxxxxx
0, 00000 Xxxxxxxx, Xxxxxxx
-hereinafter
called "MI"-
and
an
Israeli corporation having a principal place of business at
00 Xxxxx
Xxxxxx, Xxxxxxx Xxxx, Xxxxxxx 00000, Xxxxxx
-hereinafter
called "COMPANY"-
-MI and
COMPANY hereinafter also individually called a "Party", or collectively called
the "Parties"-.
PREAMBLE
At the
Max-Xxxxxx-Institute for Biophysical Chemistry in Goettingen, an institute of
the Max-Xxxxxx-Gesellschaft zur Foerderung der Wissenschaften e.V.. (hereinafter
"MPG"), a German non-profit scientific research organisation, Xx. Xxxxxx Xxxxxx
and other scientists of MPG have discovered certain microRNA sequences (internal
MI file No. MI 2916 ZJE). MPG has filed certain MPG Patent Rights (as later
defined herein) relating thereto.
MI
(formerly known as Garching Innovation GmbH or "GI") has already granted a
co-exclusive license under the MPG Patent Rights to develop and commercialize
products for Therapeutic Purposes (as later defined herein) to Alnylam
Pharmaceuticals, Inc., and to Isis Pharmaceuticals, Inc. (hereinafter the
"Therapeutic Licenses", or the "Therapeutic Licensees", as applicable). In
addition, MI has already granted, and will grant in the future, non-exclusive
licenses under the MPG Patent Rights to develop and commercialize products for
Research Purposes (as later defined herein) to various companies.
COMPANY
is focused on the development, manufacture and sale of products, and the
performance and sale of services, for Diagnostic Purposes (as later defined
herein). COMPANY desires to obtain one of four co-exclusive licenses under the
MPG Patent Rights to develop and commercialize products and services for
Diagnostic Purposes.
MPG has
authorized MI, its technology transfer agency, to act as its sole agent for
patenting and licensing the MPG Patent Rights, and to sign this Agreement in
MI's own name.
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Page
1 of 24
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
CONFIDENTIAL
MI and
COMPANY entered into a license agreement on June 30, 2006, and wish to amend and
restate such license agreement in its entirety by means of this Amended and
Restated License Agreement (the “Agreement”).
Now,
therefore, COMPANY and MI agree as follows:
ARTICLE 1 -
DEFINITIONS
1.1
|
“Affiliates"
|
shall
mean any legal entity (including, without limitation, a corporation,
partnership, or limited liability company) that controls, is controlled by, or
is under common control with COMPANY. For the purpose of this definition, the
term "control" or "controlled by" means (i) direct or indirect ownership of at
least fifty percent (50%) of the voting securities of a legal entity, or (ii) a
fifty percent (50%) or greater interest in the net assets or profits of a legal
entity, or (iii) possession, directly or indirectly, of the power to elect or
direct the management of a legal entity.
1.2
|
"Agreement"
|
shall
mean the present agreement between MI and COMPANY, including all of its
Annexes.
1.3
|
"Analyte Specific
Reagents" (or "ASRs")
|
shall
mean antibodies, both polyclonal and monoclonal, specific receptor proteins,
ligands, nucleic acid sequences, and similar reagents which, through specific
binding or chemical reaction with substances in a specimen, are intended for use
in a diagnostic application for identification and quantification of an
individual chemical substance or ligand in biological specimens. ASR's that
otherwise fall within this definition shall not fall within this definition when
they are sold to (i) in vitro diagnostic manufacturers for the purpose of
manufacturing in vitro diagnostic products, or (ii) organizations that use the
reagents to make tests for purposes other than providing diagnostic information
to patients and practitioners, e.g., forensic, academic, research, and other
non-clinical laboratories.
1.4
|
"Confidential
Information"
|
shall
mean any information which is of a confidential and proprietary nature,
including without limitation information in relation to the business of a Party
to which this Agreement relates, and information in relation to patents, patent
applications or other intellectual property rights Controlled by a
Party.
Confidential
Information will not include any information that the receiving Party can prove
by written records (i) was known by the receiving Party prior to the receipt of
Confidential Information from the disclosing Party, (ii) was disclosed to the
receiving Party by a Third Party having the right to do so, (iii) was, or
subsequently became, part of the public domain through no fault of the receiving
Party, or (iv) was subsequently and independently developed by personnel of the
receiving Party without having had access to or making use of the disclosing
Party's Confidential Information.
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Page 2 of
24
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
CONFIDENTIAL
1.5
|
"Control" or
"Controlled"
|
shall
mean, with respect to any patents, patent applications, or other intellectual
property rights, possession of the right (whether by ownership, license or
otherwise), to assign, or grant a license to, such patents, patent applications,
or other intellectual property rights without violating the terms of any
agreement with any Third Party, or any applicable law or governmental
regulation.
1.6
|
"Diagnostic
Purposes"
|
shall
mean use
a)
|
where
the medical management of a human is involved, for (aa) the measurement,
observation or determination of (i) the presence of a human disease, (ii)
the stage, progression or severity of a human disease, (iii) the risk of
contracting a disease, or (iv) the effect of a particular treatment on a
human disease; and/or (bb) the selection of patients for a particular
treatment with respect to a human disease;
and/or
|
b)
|
in
clinical laboratory for tracking, testing or quality controlling of human
body fluids or tissue samples,
and/or
|
c)
|
designated
and regulated by the FDA as a diagnostic test or ASR, to the extent used
according to (a) and/or (b) above.
|
1.7
|
"Effective
Date"
|
shall
mean June 30, 2006.
1.8
|
"FDA"
|
shall
mean (i) the United States Food and Drug Administration or any successor agency
thereto, and (ii) any non-United States agency or commission performing
comparable functions (e.g. the European Medicines Agency EMEA) or any successor
agency thereto.
1.9
|
"Field"
|
shall
mean sale and use of Licensed Products, or performance and sale of Licensed
Services, for
a)
|
COMPANY'S
internal and collaborative research and development purposes,
and
|
b)
|
Diagnostic
Purposes,
|
specifically
excluding any sale and use of Licensed Products, or performance and sale of
Licensed Services, for Research Purposes or for Therapeutic
Purposes.
1.10
|
"Licensed
Products"
|
shall
mean any product (i) that, or the development, manufacture, use or sale of
which, absent the license granted hereunder, would infringe one or more Pending
Claims or Valid Claims of the MPG Patent Rights, or (ii) which is developed or
manufactured by using a Licensed Process or that, when used, practices a
Licensed Process.
For the
purpose of this Agreement, diagnostic kits shall be considered as Licensed
Products, and Net Sales of diagnostic kits shall be considered as Net Sales of
Licensed Products, if and to the extent such diagnostic kits contain Licensed
Products as a diagnostically active
product component, together with other diagnostically non-active product
components (including without limitation buffers, purification components, or
hardware such as tubes, plates, glassware).
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Page 3 of
24
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
CONFIDENTIAL
1.11
|
"Licensed
Process"
|
shall
mean any process (i) that, absent the license granted hereunder, would infringe
one or more Pending Claims or Valid Claims of the MPG Patent Rights, or (ii)
which uses a Licensed Product.
1.12
|
"Licensed
Service"
|
shall
mean any service (i) that, or the performance or sale of which, absent the
license granted hereunder, would infringe one or more Pending Claims or Valid
Claims of the MPG Patent Rights, or (ii) which, when performed, uses a Licensed
Process or a Licensed Product.
1.13
|
"MPG Patent
Rights"
|
shall
mean:
a)
|
the
patent applications filed by MPG listed in Annex 1, and the resulting
patents,
|
b)
|
any
subsequent patent applications in any jurisdiction claiming the same
priority date and directed to the same subject matter as the patent
application listed in Annex 1, and any divisionals, continuations,
continuation-in-part applications, and continued prosecution applications
(and their relevant international equivalents) of the patent applications
listed in Annex 1, and the resulting patents,
and
|
c)
|
any
patents resulting from reissues, reexaminations (and their relevant
international equivalents) of the patents described in (a) and (b)
above.
|
1.14
|
"Net
Sales"
|
|
a)
|
shall
mean the gross amount invoiced by each of COMPANY, Affiliates, and Sales
Partners to independent Third Parties for the sale, use, lease, transfer
or other disposition of Licensed Products (including the amounts invoiced
for diagnostic kits) and Licensed Services in a first commercial sale at
arm's length transaction, less the following: (i) to the extent separately
stated on the document of sale, any taxes or duties imposed on the sale or
import of Licensed Products and Licensed Services which are actually paid,
(ii) to the extent separately stated on the document of sale, any outbound
transportation costs and costs of insurance in transit, (iii) customary
trade, cash or quantity discounts or rebates, to the extent actually
allowed and taken, (iv) amounts repaid or credited by reason of rejection
or return.
|
|
b)
|
COMPANY,
Affiliates, and Sales Partners will be treated as having sold Licensed
Products and Licensed Services for an amount equal to the fair market
value of such Licensed Products if (i) Licensed Products and Licensed
Services are internally used by each of COMPANY, Affiliates, or Sales
Partners (excluding Licensed Products used by COMPANY for COMPANY'S
internal and collaborative research and development purposes) without
charge or provision of invoice, or (ii) Licensed Products and Licensed
Services are provided to a Third Party by each of COMPANY, Affiliates or
Sales Partners without charge or provision of invoice and used by such
Third Party, except in the case of reasonable amounts of Licensed Products
and Licensed Services used as promotional free samples, free goods, or
other marketing programs to induce
sales.
|
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Page 4 of
24
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
CONFIDENTIAL
|
c)
|
If
COMPANY, Affiliates or Sales Partners sell a Licensed Product to a Third
Party in a first commercial sale at arm's length transaction for further
resale, and if the relation between COMPANY and such Third Party is a pure
seller-buyer relationship (i.e. if the agreement between COMPANY,
Affiliates or Sales Partners and such Third Party does not provide for any
obligation to share costs or revenues, or a reporting obligation, or
responsibility for sales and/or marketing efforts in a country), then the
gross amount to be included in the calculation of Net Sales shall be the
amount invoiced by COMPANY, Affiliates, or Sales Partners to such Third
Party, not the amount invoiced by such Third Party upon
resale.
|
|
d)
|
No
deductions shall be made for commissions paid to individuals or entities,
or for cost of collections. Net Sales shall occur on the date of invoice
for a Licensed Product or a Licensed
Service.
|
|
e)
|
Sales
of Licensed Products between COMPANY and its Affiliates or Sales Partners,
or among such Affiliates and Sales Partners, for a subsequent resale of
such Licensed Product to a Third Party, shall not be included in the
calculation of Net Sales, but in such cases the Net Sales shall be
calculated on the amount invoiced by such Affiliates or Sales Partners to
a Third Party upon resale.
|
1.15
|
"Pending
Claim"
|
shall
mean any claim in a pending patent application in the country in question within
the MPG Patent Rights that (i) has not been pending for more than 8 years after
the Effective Date (provided, however, that if the Parties agree on a joint
patent strategy which sets forth that certain patent applications (e.g.
divisionals, continuations-in-part) within the MPG Patent Rights will be
prosecuted with a certain delay, such 8-years-period will be prolonged
accordingly), and (ii) has not been abandoned by MPG, or finally rejected by a
competent administrative agency or court of competent jurisdiction from which no
appeal can be or is taken.
1.16
|
“Platform
Technologies”
|
shall
mean any technology for qualitative and/or quantitative detection or
quantification of nucleic acids and genotyping used in the performance of a
Licensed Service or offered as part of a Licensed Product, including, without
limitation, RNA extraction and/or PCR technologies, including, without
limitation, realtime based, microarray technologies, or any current or future
technology providing substantially similar results by any
means.
1.17
|
"Research
Purposes"
|
shall
mean use as a research reagent for basic or applied research purposes only,
specifically excluding (i) any use for Diagnostic Purposes or Therapeutic
Purposes, whether said uses are in vivo or in vitro, and (ii) any use in humans
for whatever purpose. Specifically excluded from Research Purposes are ASR
products, to the extent the ASR products are used for Diagnostic
Purposes.
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Page 5 of
24
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
CONFIDENTIAL
1.18
|
"Sales
Partners"
|
shall
mean any person or legal entity that is authorized by COMPANY or its Affiliates
by any kind of agreement to market, promote, distribute or sell, or otherwise
dispose of, Licensed Products and/or Licensed Services to a Third Party and that
is contractually required to (at least) share the revenues from sales with
COMPANY or its Affiliates. Sales Partner shall not include distributors who
purchase Licensed Products from COMPANY or its Affiliates in a first commercial
sale at arm's length transaction for further resale, and who have no obligation
to (at least) share revenues with COMPANY or its Affiliates.
1.19
|
"Sublicense
Consideration"
|
shall
mean any consideration, whether in cash (including, without limitation, initial
or upfront payments, technology access fees, annual fixed payments, and running
royalties on net sales of products sold by the Sublicensee or its sublicensees)
or in kind (including, without limitation, devices, services, licenses or any
other use rights, shares, options, warrants or any other kind of securities),
received by COMPANY from Sublicensees as consideration for or otherwise in
connection with the sublicense granted. Sublicense Consideration specifically
excludes (i) payments made by the Sublicensee to COMPANY as consideration for
COMPANY's equity (shares, options, warrants or any other kind of securities) at
fair market value, (ii) equity (shares, options, warrants or any other kind of
securities) of the Sublicensee purchased by COMPANY at fair market value, (iii)
equity investments made by, or loans granted by, Sublicensee to COMPANY in the
course of the further financing of COMPANY, (iv) payments made by the
Sublicensee to COMPANY specifically committed and allocated to reimburse COMPANY
for its actually spent prosecution and maintenance costs of the MPG Patent
Rights , and (v)
payments made by the Sublicensee to COMPANY specifically committed and allocated
to reimburse COMPANY for its actually spent costs of actually performed research
and development activities under a research agreement with the Sublicensee
specifically and directly in connection with the sublicense
granted.
1.20
|
"Sublicensee"
|
shall
mean any Third Party that is granted a sublicense to the MPG Patent Rights in
accordance with Section 2.2.
1.21
|
"Term"
|
shall
have the meaning set forth in Section 9.1 of this Agreement.
1.22
|
"Therapeutic
Purposes"
|
shall
mean all prophylactic and therapeutic uses in human diseases, in particular to
treat and/or prevent the cause and/or symptoms of human
diseases.
1.23
|
"Third
Party"
|
shall
mean any person or entity other than MI and COMPANY and their respective
Affiliates.
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Page 6 of
24
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
CONFIDENTIAL
1.24
|
"Valid
Claim"
|
shall
mean any claim in an issued patent in the country in question within the MPG
Patent Rights that (i) has not lapsed, or (ii) has not been held invalid by a
final judgment of a competent administrative agency or a court of competent
jurisdiction from which no appeal can be or is taken, or (iii) has not been
abandoned by MPG.
ARTICLE 2 - GRANT OF
RIGHTS
2.1
|
License
Grant
|
a)
|
MI
grants to COMPANY during the Term a co-exclusive, worldwide,
royalty-bearing license under the MPG Patent Rights to develop, have
developed, make, have made, use, have used, import, have imported, sell
and have sold Licensed Products, and to perform, have performed, sell and
have sold Licensed Services, each in the
Field.
|
b)
|
In
order to establish co-exclusivity, MI shall not grant, during the Term,
more than three other co-exclusive licenses to the MPG Patent Rights in
the Field with the scope as set forth in Subsection (a) above (hereinafter
the "Other Diagnostic Licenses", or the "Other Diagnostic Licensees", as
applicable).
|
2.2
|
Sublicenses
|
a)
|
COMPANY
shall have the right to grant sublicenses to the rights granted to it
under Section 2.1 to Third Parties, without seeking consent from MI,
provided that the sublicense
cumulatively:
|
i) also
includes a license to substantial intellectual property rights (e.g. pending or
issued patents that are dominant or subordinate to the MPG Patent Rights) solely
or co-owned by COMPANY in the field of "microRNAs"
ii) is
for specific products or indications, and would, absent the license granted
under Subsection (i) above, neither legally nor factually allow the Sublicensee
to manufacture, use and sell such products;
iii) permits
no more than one further tier of sublicensing (which further sublicense shall
comply with this Section 2.2(a), mutatis mutandis, and shall
contain financial terms that result in no less Sublicense Revenue being payable
to MI than would be due if the initial Sublicensee sold the Licensed Products or
Licensed Services directly).
iv) contains
provisions substantially equivalent (mutatis mutandis) to Sections 2.3, 2.4,
3.2, 3.3, 4.4, 5.10, 9.5, and 10.4 and Articles 7 and 8;
v) complies
with Sections 4.2, 4.3, 4.5, 4.6, 5.5; and
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Page 7 of
24
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
CONFIDENTIAL
vi) is
otherwise consistent with this Agreement.
Any such
sublicense that complies with this Section 2.2(a) shall be deemed to have
received the approval of MI. Any intended sublicense that fails
to comply with this Section 2.2(a) shall have no effect unless and until
approved in writing by MI.
b)
|
Within
30 days after the signature of each sublicense granted under this
Agreement, COMPANY shall provide MI with a copy of the signed sublicense
agreement.
|
c)
|
Notwithstanding
Subsection (a) above, if an insolvency event according to Section 9.8
occurs, and this Agreement is not automatically terminated according to
Section 9.8, each sublicense that COMPANY, or, as the case may be, the
insolvency administrator intends to grant after the date that the
insolvency event occurs shall be subject to the prior written approval of
MI, which shall not unreasonably be
withheld.
|
2.3
|
Retained
Rights
|
MPG
(including each and all of its Max-Xxxxxx-Institutes and other scientific
research organisations affiliated with MPG) retains the right to practice under
the MPG Patent Rights for non-commercial scientific research, teaching,
education, non-commercial collaboration (including scientific collaborations
with and/or sponsored by industry) and publication purposes.
2.4
|
No Additional
Rights
|
Nothing
in this Agreement shall be construed to confer any rights upon COMPANY, by
implication, estoppel, or otherwise, as to any intellectual property rights,
including without limitation patents and patent applications, trademarks,
copyrights and know-how, of MPG other than the MPG Patent Rights.
2.5
|
Most Favored
Licensee
|
If,
before or after the Effective Date, MI grants an Other Diagnostic License under
substantially more favorable economic terms as a whole than those in this
Agreement, then MI will notify COMPANY of such Other Diagnostic License granted.
The notice will include all material terms and conditions of such Other
Diagnostic License, including degree of co-exclusivity, duration, field,
territory, audit rights, right to sublicense, right to administer, prosecute and
enforce patents, and all license fees (e.g. initial payment, maintenance fees,
royalty rates, sublicense fees). Whether the economic terms of the Other
Diagnostic License are substantially more favorable or not shall be mutually
determined by COMPANY and MI. In the event that COMPANY elects to take all fees
and royalty rates, and all material terms and conditions of such Other
Diagnostic License, all fees and royalty rates, and all material terms and
conditions of such Other Diagnostic License shall apply as a whole to COMPANY
upon the date COMPANY provides MI with its written notice of such
election.
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Page 8 of
24
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
CONFIDENTIAL
COMPANY
acknowledges and agrees that MI may provide a copy of this Agreement to any
Other Diagnostic Licensee upon request of such Other Diagnostic
Licensee.
This
Section 2.5 shall not apply to (i) the settlement of a lawsuit or other dispute
between MI and a Third Party (including Other Diagnostic Licensees) with respect
to past infringements of the MPG Patent Rights, and (ii) any license granted by
MI to any scientific or other non-profit research organisations.
ARTICLE 3 - REPRESENTATIONS
AND WARRANTIES
3.1
|
MI
and COMPANY each represent that, to the best of their knowledge as of the
Effective Date, they have the legal right and authority to enter into this
Agreement, and to perform all obligations hereunder. MI further represents
that, to the best of its knowledge as of the Effective Date, the MPG
Patent Rights listed in Annex 1 have been assigned to MPG by the inventors
named therein, and MI is the exclusive licensor of the entire right, title
and interest in and to the MPG Patent Rights, and MI has the full right to
grant to COMPANY rights under the MPG Patent Rights as set forth in this
Agreement.
|
3.2
|
COMPANY
is informed of the MPG Patent Rights, and that it might need additional
licenses from Third Parties to practice the rights granted herein. OTHER
THAN AS EXPRESSLY PROVIDED HEREIN, MI AND MPG MAKE NO REPRESENTATIONS OR
WARRANTIES OF ANY KIND CONCERNING THE MPG PATENT RIGHTS AND LICENSED
PRODUCTS, EXPRESS OR IMPLIED, AND THE ABSENCE OF ANY LEGAL OR ACTUAL
DEFECTS, WHETHER OR NOT DISCOVERABLE. Specifically, and not to limit the
foregoing, MI and MPG make no warranty or representation (i) regarding the
merchantability or fitness for a particular purpose of the MPG Patent
Rights, (ii) regarding the patentability, validity or scope of the MPG
Patent Rights, (iii) that the commercialization of the MPG Patent Rights,
or any Licensed Product or Licensed Service, will not infringe any patents
or other intellectual property rights of MPG or of a Third Party, and (iv)
that the commercialization of the MPG Patent Rights, or any Licensed
Product or Licensed Service, will not cause any damages of any kind to
COMPANY or to a Third Party.
|
3.3
|
TO
THE EXTENT LEGALLY PERMISSIBLE, IN NO EVENT SHALL MI, MPG, THEIR TRUSTEES,
DIRECTORS, OFFICERS AND EMPLOYEES BE LIABLE FOR INCIDENTAL OR
CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING ECONOMIC DAMAGES OR INJURY TO
PROPERTY AND LOST PROFITS, REGARDLESS OF WHETHER MI OR MPG SHALL BE
ADVISED, SHALL HAVE OTHER REASON TO KNOW, OR IN FACT SHALL KNOW OF THE
POSSIBILITY OF THE FOREGOING.
|
ARTICLE 4 - COMPANY
DILIGENCE OBLIGATIONS AND REPORTS
4.1
|
Development and
Commercialization Responsibilities and Due
Diligence
|
|
a)
|
COMPANY
shall have full responsibility to use commercially reasonable efforts to
develop and commercialize, solely or jointly with or through its
Sublicensees, Licensed Products and Licensed Services in the
Field.
|
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24
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
CONFIDENTIAL
|
b)
|
In
particular, COMPANY shall use commercially reasonable efforts, and shall
oblige its Sublicensees to use commercially reasonable efforts, to obtain
all regulatory registrations or approvals necessary to manufacture, market
and sell Licensed Products worldwide, and to manufacture, or have
manufactured, Licensed Products, and to sell, or have sold, Licensed
Products in the Field worldwide, following receipt, on a
country-by-country basis, of all required regulatory registrations or
approvals.
|
4.2
|
Development and
Commercialization Reports
|
COMPANY
shall furnish to MI, and shall oblige its Affiliates and Sublicensees to furnish
to COMPANY for inclusion in its reports to MI, in writing semi-annually, within
30 (thirty) days after the end of each calendar half year, with a development
and commercialization report, stating in reasonable detail the activities and
the progress of its efforts (including the efforts of its Affiliates and
Sublicensees) during the immediately preceding calendar half year to develop and
commercialize Licensed Products and Licensed Services, on a product-by-product
and country-by-country basis. The report shall also contain a discussion of
intended development and commercialization efforts for the calendar half year in
which the report is submitted. The first report shall be provided to MI for the
second calendar half of 2006.
Any
reports furnished to MI under this Section 4.2 shall constitute Confidential
Information, and shall be treated by MI according to Article 8.
4.3
|
Compliance with
Laws
|
COMPANY
shall use best efforts to comply with, and shall use best efforts to oblige its
Affiliates and Sublicensees to comply with, all local, state, federal, and
international laws and regulations relating to the development, manufacture, use
and sale of Licensed Products, and the performance and sale of Licensed
Services.
4.4
|
Non-Use of
Names
|
Neither
COMPANY nor its Affiliates and Sublicensees may use the name of "Xxx Xxxxxx
Institute", "Xxx Xxxxxx Society", "Max-Xxxxxx-Innovation" or any variation,
adaptation, or abbreviation thereof, or of any of its trustees, officers,
faculty, students, employees, or agents, or any trademark owned by any of the
aforementioned, in any promotional material or other public announcement or
disclosure without the prior written consent of MI or, in the case of an
individual, the consent of that individual. Provided, however, that this section
4.4 shall not apply in the event that the use of the name of "Xxx Xxxxxx
Institute", "Xxx Xxxxxx Society", or "Max-Xxxxxx-Innovation" is required by law
or regulation (including without limitation by rules or regulations of any
securities exchange), provided that prior to such disclosure, COMPANY promptly
notifies MI of such requirement.
4.5
|
Liability for
Affiliates and Sublicensees
|
If
Affiliates or Sublicensees of COMPANY develop, manufacture, use and/or sell
Licensed Products or Licensed Services, COMPANY warrants and is liable towards
MI that its Affiliates and Sublicensees perform their rights and obligations in
accordance with the terms and conditions of this Agreement, and COMPANY shall be
responsible and liable for any acts and omissions, e.g. payments and reports, of
its Affiliates and Sublicensees.
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Page 10 of
24
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
CONFIDENTIAL
The grant
of any such sublicense hereunder will not relieve COMPANY of its obligations
under this Agreement. In the event that COMPANY becomes aware of a material
default by any Sublicensee, COMPANY shall inform MI and take commercially
reasonable efforts to cause the Sublicensee to cure the default; in the event of
non-cure, COMPANY will terminate the agreement with its Sublicense.
4.6
|
Effect of
Failure
|
In the
event that COMPANY or any of its Affiliates and Sublicensees have failed to
fulfill any of their obligations under this Article 4, then MI may treat such
failure as a material breach of COMPANY in accordance with Section
9.6.
ARTICLE 5 - FINANCIAL
PROVISIONS
5.1
|
Initial
Payment
|
COMPANY
shall pay to MI, within 30 days after the Effective Date, an initial payment of
EUR [***] (Euro [***]).
5.2
|
Maintenance
Fees
|
COMPANY
shall pay to MI license maintenance fees as set forth in the table below. The
respective maintenance fees are due on each January 1st of the
respective calendar year.
Calendar
Year
|
Maintenance
Fee
|
2007
|
EUR
[***]
|
2008
|
EUR
[***]
|
2009
|
EUR
[***]
|
2010
|
EUR
[***]
|
2011
and each calendar year thereafter
|
EUR
[***]
|
COMPANY's
actual earned royalties payable to MI under Section 5.3 for a certain calendar
year may be credited against the respective maintenance fee for the same
calendar year.
5.3
|
Running
Royalties
|
a)
|
COMPANY
shall pay to MI for each Licensed Product and Licensed Service running
royalties on Net Sales of
|
i) [***]%
([***] percent) in the event of a sale by COMPANY (or its Affiliates or Sales
Partners) to end users, and
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Page
11 of 24
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
CONFIDENTIAL
ii) [***]%
([***] percent) in the event of a sale by COMPANY (or its Affiliates or Sales
Partners) to distributors (that are not Sales Partners)
b)
|
In
the event of any sale of Licensed Products for non-cash consideration
(including, without limitation, devices, services, licenses or any other
use rights, shares, options, warrants or any other kind of securities),
Net Sales and the resulting running royalties shall be calculated on the
fair market value of the consideration
received.
|
5.4
|
Reduction of Running
Royalties
|
a)
|
Third Party
Licenses
|
If
COMPANY is a party to one or more license agreements with one or more Third
Parties, which license is employed in connection with the MPG Patent Rights for
the manufacture, use and/or sale of a Licensed Products, or the performance
and/or sale of a Licensed Services, and, in the aggregate, COMPANY owes running
royalties of more than [***]% ([***] percent) of Net Sales to MI and such Third
Parties, the running royalties set forth in Section 5.3 (a) will be reduced, on
a country-by-country and product-by-product basis, from the date running
royalties have to be actually paid to such Third Party, by MI’s share in the
total royalties payable by COMPANY multiplied by the difference between the
total royalties due to all Third Parties and MI and [***]% ([***] percent);
provided, however, that the running royalties due to MI will not be reduced to
less than [***]% of the royalty rate set forth in Section 5.3(a), and provided
further that the initial royalty owed to all other Third Parties (excluding
licensors of Platform Technologies) will also be reduced pursuant to the
agreement between COMPANY and such Third Parties.
For the
purpose of illustration, if COMPANY owed aggregate royalties of [***]%, then the
royalties owed to MI under Section 5.3(a) would be reduced by [***], for a
reduced royalty due under Section 5.3(a) of [***]%).
|
For
the avoidance of doubt, in no event shall the royalty rate due to MI
according to Section 5.3 (a) be reduced by the application of this Section
5.4 (a) to less than [***]% ([***] percent) in the event Section 5.3 (a)
(i) applies, or [***]% ([***] percent) in the event Section 5.3 (a) (ii)
applies.
|
5.5
|
Sublicense
Revenues
|
a)
|
Sublicense
Consideration
|
|
In
the event that COMPANY grants a sublicense to a Third Party pursuant to
Section 2.2, COMPANY shall, within thirty (30) days after its respective
receipt by COMPANY, pay to MI (i) with respect to royalty components of
Sublicense Consideration, the greater of [***]% ([***] percent) of such
royalty components of Sublicense Consideration received by COMPANY, or
[***]% ([***] percent) of the Sublicensee’s net sales of Licensed Products
and Licensed Services; MI agrees that for ease of administration, net
sales by Sublicensees may be calculated using the deductions set forth in
the applicable sublicense agreement instead of the deductions set forth in
the definition of Net Sales used herein, so long as such deductions are
commercially reasonable, and (ii) with respect to non-royalty components
of Sublicense Consideration, [***]% ([***] percent) of such non-royalty
components of Sublicense Consideration received by COMPANY; provided,
however, that MI shall in any event receive a minimum participation in
such non-royalty components of Sublicense Consideration of [***]% ([***]
percent) as set forth in Subsection (c)
below.
|
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Page 12
of 24
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.
CONFIDENTIAL
b)
|
Non-cash
Consideration
|
If
COMPANY receives any non-cash Sublicense Consideration, COMPANY shall pay MI, at
MI's election, either (i) a cash payment equal to the fair market value of the
Sublicense Consideration, or (ii) the in-kind portion, if practicable, of the
Sublicense Consideration.
c)
|
Anti-stacking of
Sublicense
Consideration.
|
|
If
COMPANY is a party to one or more license agreements with one or more
Third Parties, which license is employed in connection with the MPG Patent
Rights for the manufacture, use and/or sale of a Licensed Products, or the
performance and/or sale of a Licensed Service, and, in the aggregate,
COMPANY owes more than [***]% ([***] percent) of the total Sublicense
Consideration to MI and such Third Parties, the share of MI in the
Sublicense Consideration set forth in Section 5.5(a) will be reduced, on a
country-by-country and product-by-product basis, from the date any such
share of Sublicense Consideration must be actually paid to such Third
Parties, by MI’s share in the total Sublicense Consideration payable by
COMPANY multiplied by the difference between the total percentage of
Sublicense Consideration due to all Third Parties and MI, and [***]%
([***] percent); provided, however, that in no event, MI shall receive (i)
regarding royalty components of Sublicense Consideration, less than [***]%
([***] percent) of the Sublicensee’s net sales of Licensed Products and
Licensed Services (as set forth in Section 5.5 (a) (i) above), and (ii)
regarding non-royalty components of Sublicense Consideration, less than in
total [***]% ([***] percent) of the non-royalty components of Sublicense
Consideration. For the purpose of illustration, if COMPANY owed
[***]% in aggregate for the non-royalty components of the Sublicense
Consideration to MI and to Third Parties, then the percentage owed to MI
under Section 5.5(a) (ii) for such non-royalty components would be reduced
by [***], for a reduced percentage due under Section 5.5(a) (ii) of [***]
%.
|
5.6
|
Fair Market Value
Determination
|
In the
event that, according to this Agreement, a "fair market value" has to be
determined, the Party obliged to suggest such fair market value shall provide
the other Party in due time with a good faith determination of the fair market
value, together with any information necessary or useful to support such
determination. The other Party shall have the right to provide the suggesting
Party in due time with a counter-determination of the fair market value, which
shall include any information necessary or useful to support such
counter-determination. If the Parties are unable to agree on a fair market value
determination within 30 days after receipt of such counter-determination,
Section 10.3 applies
Xxxxxxx
Xxxxxxxxxx Xxxxxxxx, XX0000XXX
Page of
13 of 24
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended
CONFIDENTIAL
5.7
|
Reports
|
Commencing
with the first commercial sale of a Licensed Product or a Licensed Service,
within 30 (thirty) days of the end of each calendar half year, COMPANY shall
deliver a detailed report to MI for the immediately preceding calendar half year
showing at least, on a product-by-product and country-by-country basis, (i) the
kind and number of Licensed Products and Licensed Services sold by COMPANY,
Affiliates, Sublicensees and Sales Partner, (ii) the gross price charged, (iii)
the calculation of Net Sales, and (iv) the resulting running royalties or
Sublicense Consideration due to MI according to those figures. If no running
royalties or Sublicense Consideration are due to MI, the report shall so
state.
5.8
|
Payments
|
a)
|
Accounting and
Payments
|
Running
royalties shall be payable for each calendar half year, and shall be due to MI
within 30 (thirty) days of the end of each calendar half year.
b)
|
Method of
Payment
|
All
payments under this Agreement shall be made to "Max-Xxxxxx-Innovation GmbH" to
the following account:
[***]
Each
payment shall reference this Agreement and the obligation under this Agreement
that the payment satisfies.
c)
|
Payments in
Euro
|
Unless
otherwise expressly stated in this Agreement, all payments due under this
Agreement shall be payable in Euro and, if legally required, shall be paid with
the additional value added tax. Conversion of foreign currency to Euro shall be
made at the official conversion rate existing in Germany (as reported in the
Wall Street Journal on
the last working day of the relevant calendar half year. Such payments shall be
without deduction of exchange, collection, or other charges, except for
deduction of withholding or similar taxes. The Parties shall use all reasonable
and legal efforts to reduce tax withholding on payments made to MI hereunder.
Notwithstanding such efforts, if COMPANY concludes that tax with holdings under
the laws of any country are required with respect to payments to MI, COMPANY
shall withhold the required amount and pay it to the appropriate governmental
authority. In such a case, COMPANY will promptly provide MI with original
receipts or other evidence reasonably desirable and sufficient to allow MI to
document such tax withholdings adequately for purposes of claiming foreign tax
credits and similar benefits.
d)
|
Late
Payments
|
Any
payments that are not paid on or before the date such payments are due under
this Agreement shall bear interest on arrears at [***]% ([***] percent) per
year.
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Xxxxxxxxxx Xxxxxxxx, XX0000XXX
Page of 14
of 24
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended
CONFIDENTIAL
5.9
|
Bookkeeping and
Auditing
|
COMPANY
is obliged to keep, and shall oblige its Affiliates and Sublicensees and Sales
Partners to keep, complete and accurate books on any reports and payments due to
MI under this Agreement, which books shall contain sufficient information to
permit MI to confirm the accuracy of any reports and payments made to MI. MI is
authorized to check the books of COMPANY by an independent certified public
accountant (the "CPA") appointed by MI, and, upon MI's request, COMPANY or the
CPA appointed by MI for COMPANY and reasonably acceptable to the Affiliate,
Sublicensee or Sales Partner, shall check the books of its Affiliates and
Sublicensees and Sales Partners for MI, once a year. The charges for such a
check shall be borne by MI. In the event that such check reveals an underpayment
in excess of [***]% ([***] percent), COMPANY shall bear the full cost of such
check, and shall remit any amounts due to MI within thirty days of receiving
notice thereof from MI, together with interest calculated in the manner provided
in Section 5.8 (d). Any information acquired by the CPA may only be used to
confirm whether or not COMPANY (or its Affiliates, Sublicensees and Sales
Partners) is in compliance with the obligations set forth in this
Agreement.
The right
of auditing by MI under this Section shall expire [***] ([***]) years after each
report or payment has been made. Sublicenses granted by COMPANY shall provide
that COMPANY shall have the right to check the books of its Sublicensees
according to this Section 5.9. The same shall apply in respect of Sales
Partners.
5.10
|
No
Refund
|
All
payments made by COMPANY (or, as the case may be, by Affiliates and Sublicensees
and Sales Partners) under this Agreement are non-refundable and, except as set
forth in Section 5.2, non-creditable against each other. This Section 5.10 shall
apply, without limitation, in the event this Agreement is terminated prematurely
in accordance with Article 9.
ARTICLE 6 - PATENT
PROSECUTION AND INFRINGEMENT
6.1
|
Responsibility for MPG
Patent Rights
|
a)
|
MI
shall be responsible, in its sole discretion, to apply for, seek issuance
of, and maintain the MPG Patent Rights during the Term. MI shall (i) keep
COMPANY reasonably and timely informed as to the filing, prosecution, and
maintenance of the MPG Patent Rights, (ii) furnish COMPANY copies of
documents relevant to any such filing, prosecution, and maintenance, (iii)
allow COMPANY reasonable opportunity to timely comment and advise on
patent attorneys to be used and on documents to be filed with any patent
office which would affect the MPG Patent Rights in the Field, and (iv)
give good faith consideration to the comments and advice of
COMPANY. COMPANY shall be permitted to supply copies of
the correspondence between the patent attorneys and the patent offices
provided under subsections (i) and (ii) to its Affiliates, Sublicensees
and Sales Partners, subject to Section 8.2(a)
hereof.
|
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Page of 15
of 24
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended
CONFIDENTIAL
b)
|
MI
is obliged, on a country-by-country basis, to file, prosecute and maintain
the MPG Patent Rights during the Term if and to the extent each and all of
COMPANY, the Other Diagnostic Licensees and the Therapeutic Licensees pay
all their respective patent cost shares. In the event that one or more,
but not all of COMPANY, the Other Diagnostic Licensees and the Therapeutic
Licensees are willing to pay all their respective patent cost shares, the
party or parties that intend to file, prosecute and maintain the
respective patent application or patent within MPG Patent Rights are
obliged to assume, on a pro-rata basis, the patent cost shares of the
party or parties that are not willing to file, prosecute and maintain the
respective patent application or patent within MPG Patent
Rights.
|
c)
|
MI,
COMPANY, and the Other Diagnostic Licensees shall cooperate in good faith
with each other, and shall use reasonable efforts to agree upon a joint
strategy relating to the further filing, prosecution and maintenance of
the MPG Patent Rights. MI shall use reasonable efforts to induce the
Therapeutic Licensees to participate in such joint
strategy.
|
6.2
|
Patent
Costs
|
COMPANY
shall pay [***]% ([***] percent) of all fees and costs, including attorneys
fees, relating to the filing, prosecution, and maintenance of the MPG Patent
Rights, which incur during the Term in accordance with Section 6.1.
MI will
decide, in its sole discretion, if the fees and costs due pursuant to this
Section 6.2 shall be paid directly by COMPANY to the creditor, or if COMPANY
shall reimburse MI for all amounts due pursuant to this Section 6.2 within 30
(thirty) days after receiving MI's respective invoice.
6.3
|
Abandonment of MPG
Patent Rights
|
In the
event that COMPANY wishes not to file or wishes to abandon (e.g. by non-payment
of fees) any of the MPG Patent Rights, COMPANY shall notify MI thereof in
writing in due time, at least 3 months prior to any deadline. MI shall have the
right, but not the obligation, to file or to continue payment for such MPG
Patent Rights in its own discretion and at its own expense. In any event, such
MPG Patent Rights shall no longer be covered by this Agreement after three
months from the date COMPANY informs MI of its non-filing or its abandonment,
and COMPANY shall be obliged to pay [***]% of all fees and costs that incur
during such 3-months-period.
6.4
|
Infringement of MPG
Patent Rights by Third Party and Third Party
Objections
|
COMPANY
shall promptly inform MI in writing if it becomes aware of any suspected or
actual infringement of the MPG Patent Rights by any Third Party, and of any
available evidence thereof. The same shall apply in the case of an opposition,
revocation action or any other Third Party objection against the MPG Patent
Rights.
MI shall
have the right, but not the obligation, to prosecute (whether judicially or
extra-judicially) in its own discretion and at its own expense, any and all
infringements of the MPG Patent Rights, and to defend the MPG Patent Rights
against any Third Party objection.
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Xxxxxxxxxx Xxxxxxxx, XX0000XXX
Page of 16
of 24
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended
CONFIDENTIAL
MI,
COMPANY, and the Other Diagnostic Licensees shall cooperate in good faith, if
necessary and appropriate, with each other, and shall use reasonable efforts to
agree upon a joint strategy relating to the prosecution of any infringement of
the MPG Patent Rights by any Third Party, and the defense of the MPG Patent
Rights against any Third Party objection. MI shall use reasonable efforts to
induce the Therapeutic Licensees to participate in such joint
strategy.
ARTICLE 7 - INDEMNIFICATION
AND INSURANCE
7.1
|
Indemnification
|
COMPANY
shall indemnify, defend, and hold harmless MI, MPG and their trustees, officers,
faculty, students, employees, and agents and their respective successors, heirs
and assigns (collectively, the "Indemnitees"), against any and all claims,
suits, actions (including without limitation actions in the form of tort,
warranty, or strict liability and regardless of whether such action has any
factual basis), demands, judgments, liabilities, losses, damages, costs, fees or
expenses (collectively, the "Claims") incurred by or imposed upon any of the
Indemnitees by a Third Party, to the extent resulting from or arising out of (i)
any use of the MPG Patent Rights by COMPANY, its Affiliates, Sublicensees and
Sales Partners, or (ii) any product, process, or service that is developed,
made, used, sold, or performed by COMPANY, its Affiliates, Sublicensees or Sales
Partners pursuant to any right or license granted under this Agreement, or (iii)
any Third Party use of any products, processes or services sold by COMPANY, its
Affiliates, Sublicensees or Sales Partners to such Third Party.
7.2
|
Procedures
|
The
Indemnitees agree to provide COMPANY with written notice of any Claims for which
indemnification is sought under this Agreement within 30 days after the
Indemnitees have knowledge of such Claims.
COMPANY
agrees, at its own expense, to provide attorneys reasonably acceptable to MI to
defend the Indemnitees against any such Claims; provided, however, that any
Indemnitee shall have the right to retain its own counsel, at its own expense,
if representation of such Indemnitee by the counsel retained by COMPANY would be
inappropriate because of actual or potential differences in the interests of
such Indemnitee and any other party represented by such counsel.
The
Indemnitees shall (i) permit COMPANY to assume full responsibility to
investigate, prepare for and defend against any such Claims (including all
decisions relative to litigation, appeal, and settlement), and (ii) assist
COMPANY at the expense of COMPANY in the investigation, preparation and defense
of any such Claims, and (iii) not compromise or settle such Claims without the
prior consent of COMPANY.
COMPANY
shall keep MI informed of the progress in the defense and disposition of such
Claims, and COMPANY shall consult with MI with regard to any proposed
settlement. COMPANY shall not compromise or settle such Claims without the prior
written consent of MI.
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Xxxxxxxxxx Xxxxxxxx, XX0000XXX
Page of 17
of 24
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended
CONFIDENTIAL
7.3
|
Insurance
|
COMPANY
shall obtain and carry in full force and effect commercial general liability
insurance, including product liability and errors and omissions insurance, which
shall protect COMPANY and the Indemnitees with respect to events covered by
Section 7.1 above. The limit of insurance shall not be less than [***] USD
([***] US Dollar) per incident. COMPANY shall provide MI with certificates of
insurance evidencing compliance with this Section 7.3.
ARTICLE 8 -
CONFIDENTIALITY
8.1
|
Confidentiality
Obligation
|
This
Agreement and any Confidential Information disclosed to a Party under this
Agreement by the other Party shall be treated confidential by the receiving
Party during the Term and for 5 (five) years thereafter. The receiving Party
shall not use the Confidential Information for any purposes other than those
necessary to directly further the purpose of this Agreement.
8.2
|
Permitted
Disclosures
|
A Party
may disclose Confidential Information received from a disclosing Party under
this Agreement:
a)
|
to
Regulatory Authorities in connection with regulatory
filings, provided that such disclosures may be made only to the extent
reasonably necessary to make such
filings;
|
b)
|
to
Sublicensees, agents, consultants, attorneys and/or other Third Parties
for the development, manufacturing and/or marketing of Licensed Products
(or for such parties to determine their interest in performing such
activities), and as permitted under Section 6.1, in each case in
accordance with this Agreement on the condition that such Sublicensees and
Third Parties agree to be bound by the confidentiality obligations
contained in this Agreement;
|
c)
|
if
such disclosure is required by law or regulation (including without
limitation by rules or regulations of any securities exchange), provided
that prior to such disclosure, the obligated Party promptly notifies the
disclosing Party of such requirement, and provided further that the
obligated Party will furnish only that portion of the disclosing Party's
Confidential Information that it is legally required to
furnish.
|
Regarding
the disclosure of this Agreement, (i) COMPANY may disclose a mutually agreed
upon redacted copy of this Agreement on a confidential basis to prospective
investors and collaborators, and (ii) MI may disclose a copy of this Agreement
on a confidential basis to MPG and to the Other Co-Exclusive Licensees as set
forth in Sec. 2.5.
ARTICLE 9 - TERM AND
TERMINATION
9.1
|
Term
|
This
Agreement shall come into effect on the Effective Date. It shall remain in
effect until the expiration or abandonment of all issued patents and filed
patent applications within the MPG Patent Rights, unless it is earlier
terminated in accordance with the provisions of this Agreement.
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Xxxxxxxxxx Xxxxxxxx, XX0000XXX
Page of 18
of 24
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended
CONFIDENTIAL
9.2
|
Voluntary Termination
by COMPANY
|
COMPANY
shall have the right to terminate this Agreement, for any reason, (i) upon at
least 3 (three) months prior written notice to MI, such notice to state the date
at least 3 (three) months in the future upon which termination is to be
effective, and (ii) upon payment of all amounts due to MI accrued until such
termination effective date.
9.3
|
Cessation of
Business
|
If
COMPANY ceases to carry on its business related to this Agreement, COMPANY has
to inform MI thereof immediately. COMPANY and MI shall each have the right to
terminate this Agreement upon three months prior written notice to each
other.
9.4
|
Change of
Ownership
|
In the
event that at least [***]% ([***] percent) of issued and outstanding securities
of COMPANY are assigned or transferred to a Third Party, COMPANY shall provide
MI, upon Gl's request, with written reports in reasonable detail on the actual
and intended future activities of COMPANY to develop and commercialize Licensed
Products. If COMPANY does not maintain a program to develop and commercialize
Licensed Products that is substantially similar or greater in scope to the
program of COMPANY prior to the change of ownership, then MI has the right to
limit the scope and exclusivity of the license granted under this Agreement to
such Licensed Products actually covered by the program of COMPANY. COMPANY shall
inform MI promptly of the implementation of any such change of
ownership.
9.5
|
Attack on MPG Patent
Rights
|
MI shall
have the right to terminate this Agreement upon 30 days prior written notice to
COMPANY, if COMPANY attacks (e.g. by opposition, revocation or nullity actions),
or have attacked or supports an attack through a Third Party, the validity of
any of the MPG Patent Rights. For the avoidance of doubt, participation of
COMPANY in an interference proceeding between the MPG Patent Rights and patents
owned by COMPANY shall not be deemed as an attack of MPG Patent Rights under
this Section 9.5; provided that such interference proceeding is initiated by the
patent office, and not by, or induced or triggered by, COMPANY.
9.6
|
Termination for
Default
|
In the
event COMPANY fails to pay any amounts due and payable to MI hereunder, and
fails to make such payments within 30 (thirty) days after receiving written
notice of such failure, MI may terminate this Agreement immediately upon written
notice to COMPANY. Notwithstanding the foregoing, in the event COMPANY commits a
material breach of its obligations under this Agreement, and fails to cure that
breach within 60 (sixty) days after receiving written notice thereof, MI may
terminate this Agreement immediately upon written notice to
COMPANY.
Xxxxxxx
Xxxxxxxxxx Xxxxxxxx, XX0000XXX
Page of 19
of 24
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended
CONFIDENTIAL
9.7
|
Effect of
Termination
|
The
following provisions shall survive the expiration or termination of this
Agreement: Articles 1, 3, 5.7, 5.8, 5.9, 5.10, 7, 8, 10 and Section 9.7. In no
event shall termination of this Agreement release COMPANY (including its
Affiliates and Sublicensees) from the obligation to pay any amounts that became
due on or before the effective date of termination.
In the
event that any license granted by MI to COMPANY under this Agreement is
terminated, any sublicense granted by COMPANY to a Sublicensee prior to
termination of this Agreement shall remain in full force and effect, provided
that (i) the Sublicensee is not then in breach of its sublicense agreement, and
(ii) the Sublicensee agrees in writing, within thirty (30) days after the
effective date of termination, to be bound to MI as licensor under the terms and
conditions of the sublicense agreement, provided that MI shall have no other
obligation than to leave the sublicense granted by COMPANY in
place.
9.8
|
Insolvency
|
This
Agreement shall terminate automatically upon (i) the filing or institution of
bankruptcy, reorganization, liquidation, insolvency or receivership proceedings
by or against COMPANY, or (ii) the assignment of all or a substantial portion of
the assets of COMPANY for the benefit of creditors.
ARTICLE 10 -
MISCELLANEOUS
10.1
|
Notice
|
Any
notices required or permitted under this Agreement shall be in English and in
writing, shall specifically refer to this Agreement, and shall be sent to the
following addresses or facsimile numbers of the Parties:
If to
MI:
Xxx-Xxxxxx-Xxxxxxxxxx
XxxX
Xxxxxxxxxxxxxxx
0
0-80539
Muenchen/Germany
Fax:
+49/89/290919-99
If to
COMPANY:
00 Xxxxx
Xxxxxx Xxxxxxx 00000,
Xxxxxx
Fax
x00000000000
A Party
may change its contact information immediately upon written notice to the other
Party in the manner provided in this Section.
10.2
|
Governing
Law
|
This
Agreement and all disputes arising out of or related to this Agreement, or the
performance, enforcement, breach or termination hereof, and any remedies
relating thereto, shall be construed, governed, interpreted and applied in
accordance with the laws of the Federal Republic of Germany, except that
questions affecting the construction and effect of any patent shall be
determined by the law of the country in which the patent shall have been
granted.
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Page of
20 of 24
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended
CONFIDENTIAL
10.3
|
Dispute
Resolution
|
a)
|
The
Parties recognize that disputes may from time to time arise between the
Parties during the Term. In the event of such a dispute, a Party, by
written notice to the other Party, may have such dispute referred to the
Parties' respective officers or directors designated below or their
successors, for attempted resolution by good faith negotiations within 30
days after such notice is received. Said designated officers or directors
are as follows:
|
For
COMPANY:
|
Chief
Executive Officer
|
For
MI:
|
Managing
Director
|
b)
|
In
the event the designated officers or directors are not able to resolve
such dispute during such 30-day period, then the affected Party may
initiate arbitration under the procedural arbitration rules of the
American Arbitration Association in accordance with its International
Arbitration Rules. The venue for the arbitration procedure shall be
London, United Kingdom, the language shall be English, German substantive
law shall be applied, and the panel shall consist of three arbitrators
appointed in accordance with such arbitration rules. The award of the
arbitrators shall be the sole and exclusive remedy between the affected
Parties regarding any such dispute. An award rendered in connection with
an arbitration pursuant to this Section 10.3 shall be final and binding
upon the affected Parties.
|
c)
|
In
the event of a dispute relating
to
|
i) whether
a Licensed Product would, absent the license granted hereunder, infringe the MPG
Patent Rights, or
ii) the
determination of a MPG Patent Rights Value in the event of sublicenses for
pooled technologies, or
iii) the
determination of a fair market value,
the
disputing Party shall, in connection with its attempt according to Subsection
(a) above to resolve such disputes, include or involve experienced Third Parties
appointed by them (e.g. certified public accountants, patent attorneys, lawyers)
in their good faith negotiations, and in rendering judgment, the arbitrators
will be instructed by the Parties that they can only select from between the
proposals for resolution of the relevant issue presented by each Party, and not
any other proposal.
d)
|
Nothing
in this Section 10.3 shall be construed as limiting in any way the right
of a Party to seek an injunction or interlocutory relief with respect to
any actual or threatened breach of this
Agreement.
|
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21 of 24
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended
CONFIDENTIAL
10.4
|
Assignment and
Transfer
|
This
Agreement is personal to COMPANY, and neither this Agreement nor any rights or
obligations may be assigned or otherwise transferred by COMPANY to a Third Party
without the prior written consent of MI. Notwithstanding the foregoing, COMPANY
may assign this Agreement to a Third Party in connection with the merger,
consolidation, or sale of all or substantially all of its assets or that portion
of their business to which this Agreement relates; provided, however, that this
Agreement shall immediately terminate if the proposed Third Party assignee fails
to agree in writing to be bound by the terms and conditions of this Agreement on
or before the effective date of assignment. After the effective date of
assignment, the Third Party assignee shall provide MI, upon MI's request, with
written reports in reasonable detail on the actual and intended future
activities of the Third Party assignee to develop and commercialize Licensed
Products. If the Third Party assignee does not maintain a program to develop and
commercialize Licensed Products that is substantially similar or greater in
scope to the program of COMPANY after the effective date of assignment, then MI
has the right to limit the scope of the exclusive license granted under this
Agreement to such Licensed Products actually covered by the program of the Third
Party assignee.
10.5
|
Amendment and
Waiver
|
This
Agreement amends and restates the original license agreement dated June 30, 2006
by and between MI and COMPANY, which amendment and restatement shall be deemed
to be effective as of the original Effective Date. This Agreement may
be amended, supplemented, or otherwise modified only by means of a written
instrument signed by all Parties. Any waiver of any rights or failure to act in
a specific instance shall relate only to such instance and shall not be
construed as an agreement to waive any rights or fail to act in any other
instance, whether or not similar.
10.6
|
Severability
|
Should
one ore more of the provisions of this Agreement be held void, invalid or
unenforceable under applicable law, the remaining provisions of this Agreement
will not cease to be effective. The Parties shall negotiate in good faith to
replace such void, invalid or unenforceable provision by a new provision which
reflects, to the extent possible, the original intent of the
Parties.
10.7
|
Headings
|
All
headings are for convenience only and shall not affect the meaning of any
provision of this Agreement.
10.8
|
Entire
Agreement
|
This
Agreement contains the entire understanding of the Parties with respect to the
subject matter hereof, and any previous agreements and understandings, whether
oral or written, made by the Parties on the same subject matter are expressly
superseded by this Agreement.
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Page of
22 of 24
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended
CONFIDENTIAL
10.9
|
Force
Majeure
|
Neither
Party will be deemed to be in default of this Agreement for failure or delay of
the performance of its obligations or attempts to cure any breach of this
Agreement, when such failure or delay is caused by or results from causes beyond
the reasonable control of or not reasonably avoidable by the affected Party,
including, without limitation, embargoes, acts of war, strikes, lockouts or
other labour disturbances. The affected Party will notify the other Party of
such force majeure circumstances as soon as reasonably practical and will make
every reasonable effort to mitigate the effects of such force majeure
circumstances. In case of such a force majeure event, the time for performance
or cure will be extended for the period equal to the duration of such force
majeure event. Should the duration of the force majeure event exceed more than
three (3) months, each party shall be entitled to terminate this Agreement upon
three (3) months prior written notice.
10.10
|
Relationship of the
Parties
|
It is
expressly agreed that MI and COMPANY will be independent contractors and that
the relationship among the Parties will not constitute a partnership, joint
venture or agency.
10.11
|
Press
release
|
Each
Party may make public announcements with respect to the execution, nature and
general subject matter of this Agreement. The Party which intends to make such
public announcement shall provide to the other Party a copy thereof as soon as
reasonably practicable under the circumstances, but not less than one week,
prior to its scheduled release, requesting the approval of the other Party,
which shall not be unreasonably withheld.
In
witness whereof, the Parties have caused this Agreement to be executed by their
duly authorized representatives.
Max-Xxxxxx-Innovation GmbH | Rosetta Genomics Ltd | |||
By:
|
/s/ Xx Xxxx Xxxxxxxx
|
By:
|
/s/ Xxxx Xxxxxx
|
|
Name:
Xx Xxxx Xxxxxxxx
|
Name:
Xxxx Xxxxxx
|
|||
Title:
Managing Director
|
Title:
Chief Executive Officer
|
|||
Date:
3/3/09
|
Date:
2/22/09
|
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Page of
23 of 24
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended
CONFIDENTIAL
Annex
1
MPG
Patent Rights
Patent
applications filed by MPG entitled "Small expressed RNA molecules (MicroRNA
molecules )":
·
[***]
,
·
[***],
·
[***]
and
·
[***].
Xxxxxxx
Xxxxxxxxxx Xxxxxxxx, XX0000XXX
Page of
24 of 24
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Registrant’s application requesting
confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended