LICENSE AGREEMENT
by
and
between
Garching
Innovation GmbH
a
German
corporation having a principal place of business at
Xxxxxxxxxxxxxx
0, 00000 Xxxxxxxx, Xxxxxxx
-hereinafter
called “GI"-
and
an
Israeli corporation having a principal place of business at
00
Xxxxx
Xxxxxx, Xxxxxxx Xxxx, Xxxxxxx 00000, Israel
-hereinafter
called “COMPANY“-
-GI
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 GI file No. GI 2916 ZJE). MPG has filed certain MPG Patent
Rights (as later defined herein) relating thereto.
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, GI 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 GI, its technology transfer agency, to act as its sole agent for
patenting and licensing the MPG Patent Rights, and to sign this Agreement in
GI's own name. Now,
therefore, COMPANY and GI agree as follows:
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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 GI 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.
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) |
in
clinical
research 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.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
1.7
"Effective
Date"
shall
mean the date when this Agreement comes into force and effect, which shall
be
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 the sole 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).
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.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
1.14
“Net
Sales”
(a) |
shall
mean the gross amount invoiced by each of COMPANY, Affiliates,
Sublicensees 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, Sublicensees 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,
Sublicensees 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, Sublicensees 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.
|
(c) |
If
COMPANY, Affiliates,
Sublicensees
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, Sublicensees
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,
Sublicensees
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,
Sublicensees
or Sales Partners, or among such Affiliates,
Sublicensees
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,
Sublicensees or Sales Partners to a Third Party upon resale.
|
(f) |
In
the event that a Licensed Product is sold in a combination product
form
with one or more other diagnostically active product components (i.e.
other microRNAs) which are not Licensed Products and which are required
to
improve the accuracy of the Licensed Product (the "Combination Product"),
then Net Sales, for purposes of determining royalty payments on the
Combination Product, shall be calculated by multiplying the Net Sales
of
the Combination Product by [***]. In the event that a Licensed Product
is
sold in combination with other diagnostically active product component(s),
and the Licensed Product or one or more diagnostically active product
components are not sold separately, then Net Sales, for the purpose
of
determining royalty payments on the Combination Product, shall be
calculated by multiplying the Net Sales of the Combination Product
by
[***]. In the event that a Licensed Service is sold in a combination
service form, which service uses Licensed Products and one or more
other
diagnostically active product components that are not Licensed Products,
this Subsection (f) shall apply
accordingly.
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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
"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.
1.17
"Sales
Partners"
shall
mean any person or legal entity that is authorized by COMPANY or its
Affiliates
and Sublicensees
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 in a first commercial sale at arm's length transaction without
violating this Agreement or the MPG Patent Rights.
Sales
Partner shall not include wholesale distributors who purchase Licensed Products
from COMPANY or its Affiliates and Sublicensees in
a
first commercial sale at arm's length transaction for further resale, and who
have no other obligation (including without limitation any obligation to share
costs or revenues, or a reporting obligation, or responsibility for sales and/or
marketing efforts in a country) to COMPANY
or its Affiliates and Sublicensees.
1.18
"Sublicense
Consideration"
shall
mean [***] consideration, [***], received by COMPANY from Sublicensees as
consideration for or otherwise in connection with the sublicense granted.
Sublicense Consideration specifically excludes (i) [***],
(ii)
[***], (iii) [***], (iv) [***], and (v) [***]research and development activities
under a research agreement with the Sublicensee specifically and directly in
connection with the sublicense granted.
1.19
“Sublicensee”
shall
mean any Third Party that is granted a sublicense to the MPG Patent Rights
in
accordance with Section 2.2.
1.20
“Term”
shall
have the meaning set forth in Section 9.1 of this Agreement.
1.21
"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.
1.22
“Third
Party”
shall
mean any person or entity other than GI
and
COMPANY and their respective Affiliates.
1.23
"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.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
ARTICLE
2 - GRANT
OF RIGHTS
2.1
License
Grant
(a) GI
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, GI 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, subject to the terms and conditions of the following
Subsections.
(b) COMPANY
may grant sublicenses to Third Parties only if (i) the intended sublicense
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", and (ii) the intended
sublicense is reasonably necessary for COMPANY to further develop and/or
commercialise specific Licensed Products in specific indications jointly with
the intended Sublicensee, and (iii) GI has given its prior written approval
to
the intended sublicense, which shall not unreasonably be withheld; in
particular, GI may withhold its approval if the intended sublicense would be
materially detrimental to the co-exclusivity of the Other
Diagnostic Licensees.
COMPANY
shall provide GI in writing at least [***] prior to the intended signature
of
any such sublicense agreement with the final draft to permit GI to decide
whether or not to approve. Any requested approval is deemed to be granted if
GI
does not refuse the approval in writing within [***] after receiving the final
draft.
(c) Each
sublicense granted under this Agreement shall be subject and subordinate to,
and
be consistent with, the terms and conditions of this Agreement.
(d) Within
30
days after the signature of each sublicense granted under this
Agreement, COMPANY
shall provide GI with a copy
of
the signed sublicense agreement.
(e) Notwithstanding
Subsections (a) through (d) 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, shall be subject to the prior written
approval of GI, 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.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
2.5
Most
Favored Licensee
If,
before or after the Effective Date, GI grants an Other Diagnostic License under
substantially more favorable economic terms as a whole than those in this
Agreement, then GI 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 GI. 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 GI with its written notice of such
election.
COMPANY
acknowledges and agrees that GI 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 GI and a Third Party (including Other Diagnostic Licensees) with respect
to past infringements of the MPG Patent Rights, and (ii) any license granted
by
GI to any scientific or other non-profit research organisations.
ARTICLE
3 - REPRESENTATIONS AND WARRANTIES
3.1 GI
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. GI 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 GI is the
exclusive licensor of the entire right, title and interest in and to the MPG
Patent Rights, and GI 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, GI 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, GI 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 commercialisation
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 commercialisation 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 GI, 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 GI OR MPG SHALL BE ADVISED,
SHALL HAVE OTHER REASON TO KNOW, OR IN FACT SHALL KNOW OF THE POSSIBILITY OF
THE
FOREGOING.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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 its Sublicensees, Licensed
Products and Licensed Services in the Field.
(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 Commercialisation Reports
COMPANY
shall furnish to GI, and shall oblige its Affiliates and Sublicensees to furnish
to COMPANY for inclusion in its reports to GI, in writing semi-annually, within
30 (thirty) days after the end of each calendar half year, with
a
development and commercialisation 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 commercialisation efforts for the
calendar half
year
in which
the report is submitted. The first report shall be provided to GI for the second
calendar half of 2006.
Any
reports furnished to GI under this Section 4.2 shall constitute Confidential
Information, and shall be treated by GI 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”, “Garching 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 GI 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 “Garching 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 GI of such requirement.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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
GI 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.
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 GI 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
fulfil any of their obligations under this Article 4, then GI 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 GI, within 30 days after the Effective Date, an initial payment
of
EUR
[***]
(Euro [***]).
5.2
Maintenance
Fees
COMPANY
shall pay to GI 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 GI 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 GI for each Licensed Product and Licensed Service running royalties
on Net Sales of
(i) |
[***]%
(six percent) in the event of a sale by COMPANY (or its Affiliates,
Sublicensees and Sales Partners) to end users,
and
|
(ii) |
[***]%
(twelve percent) in the event of a sale by COMPANY (or its Affiliates,
Sublicensees and 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 a license agreement with any Third Party, 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, 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 up to [***]% of
any
running royalty owed to such Third Party for the manufacture, use or sale of
a
Licensed Product; provided, however, that the running royalties due to GI 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 the Third Party
will also be reduced on a pro-rata basis.
In
no
event shall the royalty rate due to GI according to Section 5.3 (a) be reduced
by the application of this Section 5.4 (a) to less than [***]% (three percent)
in the event Section 5.3 (a) (i) applies, or [***]% (six percent) in the event
Section 5.3 (a) (ii) applies.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
(b)
Combination
Product Minimum Royalty Floor
In
the
event that Licensed Products are sold as Combination Products, the royalty
rate
stated in Section 5.3 (a) on Net Sales of such Combination Product (without
taking into account the determination and allocation of Net Sales of Licensed
Products contained in Combination Products) shall in no event be reduced (i)
by
the application of the formula contained in Section 1.14 (f), or (ii) by the
application of the formula contained in Section 1.14 (f) together with the
reduction mechanism set forth in Section 5.4 (a) above, to less than a minimum
royalty rate of of Net Sales of any such Combination Product (without taking
into account the determination and allocation of Net Sales of Licensed Products
contained in Combination Products) of [***]% (two percent) in the event Section
5.3 (a) (i) applies, or [***]% (four 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 pay to GI [***]% (twenty percent) of all Sublicense Consideration
received, due within [***] after the respective receipt.
(b) Non-cash
Consideration
If
COMPANY receives any non-cash Sublicense Consideration, COMPANY shall pay GI,
at
GI’s election, either (i) a [***] the Sublicense Consideration, or (ii) the
[***] the Sublicense Consideration.
(c)
Relative
Value of Pooled Technologies
As
COMPANY may only grant sublicenses to a Third Party that includes a license
to
substantial intellectual property rights Controlled by COMPANY in the field
of
"microRNAs", the percentage of the Sublicense Consideration due to GI according
to Subsection (a) above shall be based on [***].
At
least
30 days prior to the intended signature of any sublicense agreement, COMPANY
shall suggest to GI, together with the request for approving the intended
sublicense, the MPG Patent Rights Value based on a good faith fair market value
determination, with any information reasonably necessary or useful for GI to
evaluate such suggestion. If, within 30 days after receipt of the information,
GI objects for cause to the suggested MPG Patent Rights Value, Sec. 10.3
applies.
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.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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 GI 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 due to GI
according to those figures. If no running royalties are due to GI, 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
GI
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 “Garching 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 GI hereunder.
Notwithstanding such efforts, if COMPANY concludes that tax withholdings under
the laws of any country are required with respect to payments to GI, COMPANY
shall withhold the required amount and pay it to the appropriate governmental
authority. In such a case, COMPANY will promptly provide GI with original
receipts or other evidence reasonably desirable and sufficient to allow GI
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.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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
GI under this Agreement, which books shall contain sufficient information to
permit GI to confirm the accuracy of any reports and payments made to GI. GI
is
authorized to check the books of COMPANY by an independent certified public
accountant, and, upon GI’s request, COMPANY, or agents appointed by GI for
COMPANY, shall check the books of its Affiliates and Sublicensees and Sales
Partners for GI, once a year. The charges for such a check shall be borne by
GI.
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 GI within thirty days of receiving notice thereof from GI,
together with interest calculated in the manner provided in Section 5.8 (d).
Any
information acquired by the auditor 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 GI under this Section shall expire [***]
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) GI
shall
be responsible, in its sole discretion, to apply for, seek issuance of, and
maintain the MPG Patent Rights during the Term. GI 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.
(b) GI
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 to file,
prosecute and maintain the respective patent application or patent within MPG
Patent Rights.
(c) GI,
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. GI 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.
GI
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 GI for all amounts due pursuant to this Section 6.2 within
30
(thirty) days after receiving GI's respective invoice.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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 GI thereof in
writing in due time, at least 3 months prior to any deadline. GI 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 GI 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 GI 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.
GI
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.
GI,
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. GI 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 GI, 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 GI
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 GI informed of the progress in the defense and disposition of such
Claims, and COMPANY shall consult with GI with regard to any proposed
settlement. COMPANY shall not compromise or settle such Claims without the
prior
written consent of GI.
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 GI with certificates of insurance evidencing compliance
with this Section 7.3.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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) 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)
GI 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.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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 GI, 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 GI 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 GI thereof immediately. COMPANY and GI 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
GI, upon GI’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 GI 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 GI promptly
of the
implementation of any such change of ownership.
9.5
Attack
on MPG Patent Rights
GI
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 GI hereunder, and
fails to make such payments within 30 (thirty) days after receiving written
notice of such failure, GI 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, GI may
terminate this Agreement immediately upon written notice to
COMPANY.
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 GI 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 GI as licensor under the terms and conditions
of
the sublicense agreement, provided that GI 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.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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 GI:
|
Garching
Innovation GmbH
|
Xxxxxxxxxxxxxxx
0
|
|
X-00000
Xxxxxxxx/Xxxxxxx
|
|
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.
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
GI:
|
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.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
(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) |
whether
a Licensed Product is sold in a Combination Product form,
or
|
(iii) |
the
determination of a MPG Patent Rights Value in the event of sublicenses
for
pooled technologies, or
|
(iv) |
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.
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 GI. 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 GI, upon GI’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 GI 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 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.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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 GI 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.
Garching
Innovation GmbH
|
|||
By:
|
By:
|
||
Name:
|
Xx.
Xxxx Xxxxxxxx
|
Name:
|
Xxxx
Xxxxxx
|
Title:
|
Managing
Director
|
Title:
|
Chief
Executive Officer
|
Date:
|
Date:
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Annex
1
MPG
Patent Rights
Patent
applications filed by MPG entitled "Small expressed RNA molecules (MicroRNA
molecules)":
· |
[***],
|
· |
[***],
|
· |
[***]
and
|
· |
[***].
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.