COLLABORATION AND LICENSE AGREEMENT by and between ROSETTA GENOMICS, LTD. and AMBION DIAGNOSTICS, INC. January 5, 2006
Execution
Copy
by
and
between
ROSETTA
GENOMICS, LTD.
and
AMBION
DIAGNOSTICS, INC.
January
5, 2006
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.
TABLE
OF CONTENTS
1.
|
DEFINITIONS
|
1
|
2.
|
DEVELOPMENT
AND COMMERCIALIZATION OF PRODUCTS AND SERVICES
|
11
|
2.1
|
Development
Programs.
|
11
|
2.2
|
Development
and Commercialization.
|
13
|
2.3
|
Information
Updates.
|
14
|
2.4
|
Joint
Steering Committee.
|
15
|
3.
|
CONSIDERATION
|
16
|
3.1
|
Payment
of Royalties; Royalty Rates; Accounting and Records.
|
16
|
3.2
|
Sublicense
Income
|
19
|
4.
|
TREATMENT
OF CONFIDENTIAL INFORMATION; PUBLICITY NON-SOLICITATION.
|
19
|
4.1
|
Confidentiality.
|
19
|
4.2
|
Publicity
|
20
|
4.3
|
Publications
and Presentations
|
20
|
4.4
|
Prohibition
on Solicitation
|
21
|
5.
|
LICENSE
GRANTS; RESTRICTIONS ON USE
|
21
|
5.1
|
Grant
of Rights to AMBION.
|
21
|
5.2
|
Grant
of Rights to ROSETTA.
|
22
|
6.
|
INTELLECTUAL
PROPERTY R.IGHTS
|
23
|
6.1
|
Disclosure
of Inventions
|
23
|
6.2
|
Patent
Coordinators
|
24
|
6.3
|
Inventorship
|
24
|
7.
|
FILING,
PROSECUTION AND MAINTENANCE OF PATENT RIGHTS
|
24
|
7.1
|
Patent
Filing, Prosecution and Maintenance
|
24
|
7.2
|
Legal
Actions.
|
25
|
8.
|
TERM
AND TERMINATION
|
27
|
8.1
|
Term
|
27
|
8.2
|
Termination
|
27
|
8.3
|
Consequences
of Termination of Agreement
|
28
|
8.4
|
Surviving
Provisions
|
30
|
9.
|
REPRESENTATIONS
AND WARRANTIES
|
30
|
9.1
|
Mutual
Representations and Warranties
|
30
|
9.2
|
Additional
Representations of ROSETTA
|
30
|
10.
|
IDEMNIFICATION
|
31
|
10.1
|
Idemnification
of AMBION by ROSETTA
|
31
|
10.2
|
Indemnification
of ROSETTA by AMBION
|
31
|
10.3
|
Conditions
to Indemnification
|
31
|
10.4
|
Warrant
Disclaimer
|
32
|
10.5
|
No
Warranty of Success
|
32
|
10.6
|
Limited
Liability
|
32
|
10.7
|
Insurance
|
32
|
11.
|
DISPUTE
RESOLUTION
|
32
|
11.1
|
Dispute
Resolution
|
32
|
12.
|
MISCELLANEOUS
|
34
|
12.1
|
Notices
|
34
|
12.2
|
Governing
Law
|
34
|
12.3
|
Binding
Effect
|
35
|
12.4
|
Headings
|
35
|
12.5
|
Counterparts
|
35
|
12.6
|
Amendment;
Waiver
|
35
|
12.7
|
No
Third Party Beneficiaries
|
35
|
12.8
|
Purposes
and Scope
|
35
|
12.9
|
Assignment
and Successors
|
35
|
12.10
|
Force
Majeure
|
35
|
12.11
|
Interpretation
|
36
|
12.12
|
Integration;
Severability
|
36
|
12.13
|
Further
Assurances
|
36
|
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.
This
COLLABORATION AND LICENSE AGREEMENT (this “Agreement”) is entered into as of
January 5, 2006, by and between Rosetta Genomics, Ltd., a corporation organized
under the country of Israel having an address of 00 Xxxxx Xxxxxx, Xxxxxxx Xxxx,
Xxxxxxx, Xxxxxx (“ROSETTA”) and Ambion Diagnostics, Inc., a Delaware corporation
having an address of 0000 Xxxxxxxx Xx., Xxxxxx, Xxxxx 00000 (“AMBION”). Each of
AMBION and ROSETTA is sometimes referred to individually herein as a “Party” and
collectively as the “Parties.”
WHEREAS,
ROSETTA has developed confidential and proprietary technology relating to
microRNA sequences including an algorithm for the prediction of microRNAs,
techniques for validation of predicted microRNAs on a given material, microRNA
expression profiling technology, analysis algorithms for the detection of
biomarkers based on microRNA expression profiling and techniques for
establishing the relationships between microRNAs and diseases and has identified
a large number of micro RNA sequences using certain of its proprietary
technology and/or proprietary materials; and
WHEREAS,
AMBION is in the business of designing, developing, manufacturing and selling
diagnostic kits and services, including diagnostic kits and services that use
microRNA sequences and profiles; and
WHEREAS,
ROSETTA and AMBION desire to enter into a collaboration for the purpose of
developing one or more diagnostic tests using ROSETTA’s microRNA sequences or
microRNA sequences analyzed or identified by ROSETTA and/or certain other
ROSETTA proprietary technology for use in the diagnosis of prostate cancer;
and
WHEREAS,
ROSETTA and AMBION desire to collaborate to develop and commercialize diagnostic
tests for prostate cancer which incorporate ROSETTA’s microRNA sequences or
microRNA sequences analyzed or identified by ROSETTA and/or certain other
proprietary technology of ROSETTA.
NOW,
THEREFORE, in consideration of the mutual covenants contained herein, and for
other good and valuable consideration, the Parties hereto, intending to be
legally bound, hereby agree as follows:
1. DEFINITIONS
Whenever
used in this Agreement with an initial capital letter, the terms defined in
this
Section 1 shall have the meanings specified.
1.1 “Affiliate”
means,
with respect to any Party, any Person that, directly or through one or more
Affiliates, controls, or is controlled by, or is under common control with,
such
Party. For purposes of this definition only, “control” means (a) ownership of
more than fifty percent (50%) of the shares of stock entitled to vote for the
election of directors, in the case of a corporation, or more than fifty percent
(50%) of the equity interests in the case of any other type of legal entity,
(b)
status as a general partner in any partnership, or (c) any other arrangement
whereby a Person controls or has the right to control the Board of Directors
or
equivalent governing body of a corporation or other entity.
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
1.2 “AMBION
Background Technology”
means
any Technology used by AMBION, or provided by AMBION for use, in the Development
Program that is useful in the Field and that is (a) Controlled by AMBION as
of
the Effective Date or (b) developed or conceived by employees of, or consultants
to, AMBION after the Effective Date in the conduct of activities outside the
Development Program and without the use in any material respect of any ROSETTA
Technology, ROSETTA Materials or any Program Invention.
1.3 “AMBION
Materials”
means
any Proprietary Materials Controlled by AMBION and used by AMBION, or provided
by AMBION for use, in the Development Program.
1.4 “XXXXXX
xxXXX Profile”
means
any Confidential Information Controlled by AMBION and used by AMBION, or
provided by AMBION for use, in the Development Program during the Term of this
Agreement with respect to the abundance of a given xxXXX Sequence within a
Tissue Sample of a Prostate Cancer tumor. Any XXXXXX xxXXX Profile is AMBION
Program Technology or AMBION Background Technology, as the case may
be.
1.5 “AMBION
Patent Rights”
means
any Patent Rights containing one or more claims that cover AMBION
Technology.
1.6 “AMBION
Program Technology”
means
any Program Invention conceived or first reduced to practice by employees of,
or
consultants to, AMBION, alone or jointly with Third Parties, without the use
in
any material respect of any ROSETTA Technology, ROSETTA Materials or Joint
Program Technology.
1.7 “AMBION
Results”
means
all data and information generated by AMBION in the Development Program or
otherwise in the Development of Collaboration Products or Collaboration
Services.
1.8 “AMBION
Technology”
means,
collectively, AMBION Background Technology and AMBION Program
Technology.
1.9 “AMBION
Tissue Samples”
means
the tissue or body fluid samples identified by AMBION and used by AMBION, or
provided by AMBION for use, in the Development Program.
1.10 “Annual
Net Sales”
means
the aggregate Net Sales during a particular Calendar Year.
1.11 “Applicable
Laws”
means
all Federal, state, local, national and supra-national laws, statutes, rules
and
regulations, including any rules, regulations, guidelines or requirements of
Regulatory Authorities, national securities exchanges or securities listing
organizations that may be in effect from time to time during the Term and
applicable to a particular activity hereunder.
1.12 “ASR”
means
any analyte specific reagent, as defined in 21 CFR 864.4020, that is exempt
from
the 510(k) Premarket Notification Requirements.
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
1.13 “Calendar
Quarter”
means
the period beginning on the Effective Date and ending on the last day of the
calendar quarter in which the Effective Date falls, and thereafter each
successive period of three (3) consecutive calendar months ending on March
31,
June 30, September 30 or December 31.
1.14 “Calendar
Year”
means
each successive period of twelve (12) months commencing on January 1 and ending
on December 31.
1.15 “Cancer”
means
any type of malignant neoplasm which may or may not result in
metastasis.
1.16 “Collaboration”
means
the association of ROSETTA and AMBIQN established pursuant to this Agreement
for
the purpose of conducting the Development Program in order to Develop and
Commercialize Collaboration Products and Collaboration Services in the Field
in
the Territory.
1.17 “Collaboration
Product”
means
any product for Diagnosis of Prostate Cancer that incorporates, or is otherwise
Derived from, or is designed to detect (a) at least one (1) ROSETTA xxXXX
Sequence or (b) at least one (1) Public xxXXX Sequence that is used in the
Development Program. For purposes of clarity, all Collaboration Products shall
be listed in Schedule
3
attached
hereto, as updated from time to time by AMBION during the Term.
1.18 “Collaboration
Service”
means
any service within the Field that is provided through the use of a Collaboration
Product or a ROSETTA xxXXX profile.
1.19 “Commercialization”
or
“Commercialize”
means
any and all activities directed to the commercialization of a Collaboration
Product or Collaboration Service, including pre-launch and post-launch
marketing, manufacturing for commercial sale, promoting, detailing,
distributing, offering to sell or provide and selling or providing a
Collaboration Product or Collaboration Service, importing or exporting a
Collaboration Product for sale, providing a Collaboration Service, and
interacting with Regulatory Authorities regarding the foregoing. When used
as a
verb, “Commercializing”
means
to engage in Commercialization.
1.20 “Confidential
Information”
means
(a) with respect to ROSETTA, all tangible embodiments of ROSETTA Technology,
(b)
with respect to AMBION, all tangible embodiments of AMBION Technology and (c)
with respect to each Party, (i) all tangible embodiments of Joint Program
Technology and (ii) all information, Technology and Proprietary Materials
disclosed or provided by of on behalf of such Party (the “disclosing Party”)
pursuant to this Agreement to the other Party (the “receiving Party”) or to any
of the receiving Party’s employees, consultants, Affiliates or sublicensees;
provided that none of the foregoing shall be Confidential Information if: (A)
as
of the date of disclosure, it is known to the receiving Party or its Affiliates,
as demonstrated by credible written documentation, other than by virtue of
a
prior confidential disclosure to such receiving Party or its Affiliates; (B)
as
of the date of disclosure it is in the public domain, or it subsequently enters
the public domain through no fault of the receiving Party or its Affiliates;
(C)
it is obtained by the receiving Party from a Third Party having a lawful right
to make such disclosure free from any obligation of confidentiality to the
disclosing Party; or (D) it is independently developed by or for the receiving
Party without reference to or use of any Confidential Information of the
disclosing Party as demonstrated by credible written documentation. For purposes
of clarity, the terms of this Agreement shall constitute Confidential
Information of each Party.
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.
3
1.21 “Control”
or
“Controlled”
means
(a) with respect to Technology (other than Proprietary Materials), Patent Rights
or Confidential Information (including data and results), the possession by
a
Party of the right to grant a license or sublicense to such Technology or Patent
Rights, or provide such Confidential Information as provided herein without
the
payment of additional consideration to, and without violating the terms of
any
agreement or arrangement with, any Third Party and (b) with respect to
Proprietary Materials, the possession by a Party of the right to supply such
Proprietary Materials to the other Party as provided herein without the payment
of additional consideration to, and without violating the terms of any agreement
or arrangement with, any Third Party.
1.22 “Derived”
means
obtained, developed, created, synthesized, designed, derived or otherwise
generated from or based upon (whether directly or indirectly, or in whole or
in
part).
1.23 “Designated
Senior Officer”
means,
with respect, to a Party, the senior officer designated by such Party to have
final decision-making authority over Disputed Matters which, absent unusual
circumstances, shall be the President or Chief Executive Officer of such
Party.
1.24 “Development”
or
“Develop”
means,
with respect to each Collaboration Product or Collaboration Service, all
research and development activities required to obtain Regulatory Approval
of
such Collaboration Product or Collaboration Service in the Field and in the
Territory in accordance with this Agreement to the extent required or, to the
extent Regulatory Approval is not required, to commence commercial sale thereof
(including without limitation in
vitro
studies,
animal studies, formulation, process development, clinical studies,
manufacturing, manufacturing scale-up, development-stage manufacturing, and
quality assurance quality control development. When used as a verb,
“Developing”
means
to engage in Development.
1.25 “Development
Plan”
means
the written plan describing the Development activities to be carried out by
each
Party under the Development Program during the Term commencing with the
Effective Date. The initial Development Plan is attached hereto as Exhibit A.
The
Development Plan consists of two (2) stages, the “Discovery Stage” and the
“Clinical Development Stage.”‘
1.26 “Development
Program”
means
the development program to be conducted by the Parties pursuant to Article
2 of
this Agreement.
1.27 “Diagnosis”
means
(a) the determination of (i) the presence of a disease, (ii) the stage,
progression or severity of a disease, or (iii) the effect on a disease of a
particular treatment; and/or (b) the selection of patients for a particular
treatment with respect to a disease.
1.28 “Discovery
Stage Technology”
means
any Program Invention arising in the Discovery Stage of the Development
Program.
1.29 “Discovery
Stage Patent Rights”
means
Patent Rights that contain one or more claims covering Discovery Stage
Technology.
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
1.30 “Effective
Date”
means
the date first set forth above.
1.31 “FDA”
means
the United States Food and Drug Administration or any successor agency or
authority thereto.
1.32 “FDCA”
means
the United, States Federal Food, Drug, and Cosmetic Act, as
amended.
1.33 “Field”
means
the Diagnosis of Prostate Cancer (including without limitation the use of a
Collaboration Product or the providing of a Collaboration Service for the
Diagnosis of Prostate Cancer). For purposes of clarity, the Field shall include
the use, in the Diagnosis of Prostate Cancer, of a Collaboration Product or
Collaboration Service by a clinical laboratory in a laboratory assay which
contains an ASR.
1.34 “First
Commercial Sale”
means,
with respect to a Collaboration Product or Collaboration Service in any country
in the Territory, the first sale, transfer or disposition for value or for
end
use or consumption or use of such Collaboration Product or services constituting
such Collaboration Service in such country; provided, that, any sale to an
Affiliate or Sublicensee will not constitute a First Commercial Sale unless
the
Affiliate or Sublicensee is the last entity in the distribution chain of the
Collaboration Product or Collaboration Service.
1.35 “Force
Majeure”
means
any occurrence beyond the reasonable control of a Party that (a) prevents or
substantially interferes with the performance by such Party of any of its
obligations hereunder and (b) occurs by reason of any act of God, flood, fire,
explosion, earthquake, strike, lockout; labor dispute, casualty or accident,
or
war, revolution, civil commotion, act of terrorism, blockage or embargo, or
any
injunction, law, order, proclamation, regulation, ordinance, demand or
requirement of any government or of any subdivision, authority or representative
of any such government.
1.36 “IDE”
means
an Investigational Device Exemption (as defined in Title 21 of the United States
Code of Federal Regulations, as amended from time to time) filed or to be filed
with the FDA with regard to any Collaboration Product or Collaboration
Services.
1.37 “Joint
Program Patent Rights”
means
Patent Rights that contain one or more claims that cover Joint Program
Technology.
1.38 “Joint
Program Technology”
means
any Program Invention conceived or first reduced to practice jointly by
employees of, or consultants to, AMBION and employees of, or consultants to,
ROSETTA.
1.39 “Joint
Steering Committee”
or
“JSC”
means
the Joint Steering Committee of ROSETTA and AMBION representatives established
pursuant to Section 2.4.
1.40 “Licensed
Patent Rights”
means
any ROSETTA Patent Rights or Joint Program Patent Rights that (a) contain one
or
more claims that cover any Collaboration Product or Collaboration Service or
(b)
are necessary or useful for AMBION to exercise the license granted to it
pursuant to Section 5.1.1. For purposes of clarity (a) all Licensed Patent
Rights existing as of the Effective Date are described on Schedule
2
attached
hereto and (b) Schedule
2
shall be
amended by ROSETTA during the Term to include any updates to any filings listed
therein and to include any new Patent Rights that become Licensed Patent Rights
for purposes of this Agreement. Whether or not a patent is listed on Schedule
2
is not determinative of the ownership or licensed or unlicensed status of such
patent.
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
1.41 “Licensed
Technology”
means
any ROSETTA Technology or Joint Program Technology that (a) relates to any
Collaboration Product or Collaboration Service or (b) is necessary or useful
for
AMBION to exercise the license granted to it pursuant to Section
5.1.1.
1.42 “MicroRNA
Profiles”
or
“xxXXX
Profiles”
means
XXXXXX xxXXX Profiles and XXXXXX xxXXX Profiles.
1.43 “MicroRNA
Sequence”
or
“xxXXX
Sequence”
means
a
short RNA sequence that is encoded in the human genome in a hairpin structure,
wherein such sequence is predicted to be expressed and/or is expressed in cells.
1.44 “Net
Sales”
means
the gross amount billed or invoiced by AMBION or any of its Affiliates or
Sublicensees to Third Parties (including, without limitation Distributors)
throughout the Territory for sales or other dispositions or transfers for value
of Collaboration Products or the providing of Collaboration Services, less
(a)
allowances for normal and customary trade, quantity and cash discounts actually
allowed and taken, (b) transportation, insurance and postage charges, if prepaid
by AMBION or any Affiliate or Sublicensee of AMBION and included on any such
party’s xxxx or invoice as a separate item, (c) credits, rebates, returns
(including, without limitation, wholesaler and retailer returns), to the extent
actually allowed, (d) sales, use and other consumption taxes similarly incurred
to the extent stated on the invoice as a separate item, and (e) royalties paid
to Third Parties under a license to an issued or pending patent in the absence
of which the xxXXX Sequence in the Collaboration Product or Collaboration
Service could not legally be sold or used. In addition, Net Sales are subject
to
the following:
If
AMBION
or any of its Affiliates or Sublicensees effects a sale, disposition or other
transfer of a Collaboration Product or provides Collaboration Services to a
customer in a particular country other than in an arms length transaction solely
for monetary consideration, the Net Sales of such Collaboration Product or
Collaboration Service to such customer shall be deemed to be “the fair market
value” of such Collaboration Product or Collaboration Service. For purposes of
this subsection (i), “fair market value” shall mean the value that would have
been derived had such Collaboration Product been sold or Collaboration Service
been provided as a separate product or service to another customer in the
country concerned in an arms length transaction solely for monetary
consideration. For avoidance of doubt, the provision of any Collaboration
Product to a customer for product evaluation purposes without any consideration
in the ordinary course of business shall not require the fair market value
thereof to be included in Net Sales.
1.45 “Non-Validated
xxXXX Sequence”
means
any xxXXX Sequence that is not a Validated xxXXX Sequence.
1.46 “Patent
Rights”
means
the rights and interests in and to issued patents and pending patent
applications (which, for purposes of this Agreement, include certificates of
invention, applications for certificates of invention and priority rights)
in
any country or region, including all provisional applications, substitutions,
continuations, continuations-in-part, divisions, renewals, all letters patent
granted thereon, and all reissues, reexaminations and extensions thereof, and
all foreign counterparts of any 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.
6
1.47 “Person”
means
an individual, sole proprietorship, partnership, limited partnership, limited
liability partnership, corporation, limited liability company, business trust,
joint stock company, trust, incorporated association, joint venture or similar
entity or organization, including a government or political subdivision,
department or agency of a government.
1.48 “Program
Invention”
means
any Technology (including, without limitation, any new and useful process,
method of manufacture or composition of matter) that is conceived or first
reduced to practice (actually or constructively) in the conduct of the
Development Program. Technology that is conceived or reduced to practice by
either Party and that relates to the development of the platform on which to
run
the tests associated with the Development Program shall be Program Technology
of
the Party conceiving or reducing such Technology to practice and shall only
be
Joint Program Technology if covered by Section 1.38.
1.49 “Proprietary
Materials”
means
tangible chemical, biological or physical materials that are furnished by or
on
behalf of one Party to the other Party in connection with this Agreement,
whether or not specifically designated as proprietary by the transferring
Party.
1.50 “Prostate
Cancer”
means,
with respect to a patient. a primary tumor of the prostate of such patient,
a
metastatic tumor located outside the prostate of such patient having the same
genetic makeup as a primary tumor of the prostate in such patient, or a
condition of such patient’s prostate or other tissue that indicates the
likelihood of developing a primary tumor of the prostate or such a metastatic
tumor.
1.51 “Prostate
Cancer Therapeutic Field”
means
any Therapy of Prostate Cancer.
1.52 “Public
xxXXX Sequence”
means
any xxXXX Sequence that is used by ROSETTA, or provided by ROSETTA for use,
in
the Development Program and that is (a) included in the sequence database of
the
Sanger Institute prior to the Effective Date or (b) published as a Validated
xxXXX Sequence by a Third Party in a publicly available scientific journal
prior
to the Effective Date; provided that any xxXXX Sequence that was published
or
entered in the xxxxxxxx xxxx base of the Sanger Institute by ROSETTA or that
is
claimed in a patent application filed by ROSETTA before the publication or
insertion in the xxxxxxxx xxxx base of the Sanger Institute by a Third Party
shall be a ROSETTA xxXXX Sequence and not a Public xxXXX Sequence.
1.53 “Regulatory
Approval”
means,
with respect to any country or region in the Territory, any approval (including,
without limitation, any pricing approval), product and establishment license,
registration or authorization of any Regulatory Authority required for the
manufacture, use, storage, importation, export, transport or sale of a
Collaboration Product or Collaboration Service for use in the Field in such
country or region. Regulatory Approval shall include, without limitation, any
510(k) Pre-Market clearance, FDA Pre-Market Approval and/or IDE.
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.
7
1.54 “Regulatory
Authority”
means
the FDA or any counterpart of the FDA outside the United States, or other
national, supra-national, regional, state or local regulatory agency,
department, bureau, commission, council or other governmental entity with
authority over the distribution, importation, exportation, manufacture,
production, use, storage, transport, clinical testing or sale of a Collaboration
Product or Collaboration Service.
1.55 “Regulatory
Filings”
means,
collectively, (a) any 510(k) Pre-Market Notification, PMA, IDE or all other
similar filings (including, without limitation, any counterparts of any of
the
foregoing in any country region in the Territory) as may be required by any
Regulatory Authority for the Development or Commercialization of a Collaboration
Product or Collaboration Service within the Field and in the Territory; (b)
all
supplements and amendments to any of the foregoing; and (c) all data contained
in, and correspondence relating to, any of the foregoing.
1.56 “ROSETTA
Background Technology”
means
any Technology used by ROSETTA, or provided by ROSETTA for use, in the
Development Program that is useful in the Field and that is (a) Controlled
by
ROSETTA as of the Effective Date or (b) conceived or first reduced to practice
by employees of, or consultants to, ROSETTA after the Effective Date in the
conduct of activities outside the Development Program and without the use in
any
material respect of any AMBION Technology or any Program Inventions. For
purposes of clarity, ROSETTA Background Technology includes all ROSETTA xxXXX
Sequences.
1.57 “ROSETTA
Materials”
means
any Proprietary Materials Controlled by ROSETTA and used by ROSETTA, or provided
by ROSETTA for use, in the Development Program.
1.58 “ROSETTA
xxXXX Profile”
means
any Confidential Information Controlled by ROSETTA and used by ROSETTA, or
provided by ROSETTA for use, in the Development Program during the Term of
this
Agreement with respect to the abundance of a given xxXXX Sequence within a
Tissue Sample of a Prostate Cancer tumor. Any ROSETTA xxXXX Profile is ROSETTA
Program Technology or ROSETTA Background Technology, as the case may
be.
1.59 “ROSETTA
xxXXX Sequence”
means
any xxXXX Sequence (including without limitation any Validated xxXXX Sequence
and Non-Validated xxXXX Sequence) that (a) (i) was bioinformatically predicted
or validated by ROSETTA prior to the Effective Date or is bioinformatically
predicted or validated by ROSETTA during the Term of this, Agreement; and (ii)
is covered by a Valid Claim within a pending patent application; or (b) is
covered by an issued and unexpired patent within a Valid Claim; or (C) is
licensed by ROSETTA from a Third Party.
1.60 “ROSETTA
Patent Rights”
means
any Patent Rights that contain one or more claims that cover ROSETTA
Technology.
1.61 “ROSETTA
Program Technology”
means
any Program Invention conceived or first reduced to practice by employees of,
or
consultants to, ROSETTA, alone or jointly with any Third Party, without the
use
in any material respect of any AMBION Technology, AMBION Materials or Joint
Program Technology.
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.
8
1.62 “ROSETTA
Results”
means
all data and information generated by ROSETTA in the
Development Program or otherwise in the Development of Collaboration
Products
or Collaboration Services.
1.63 “ROSETTA
Technology”
means,
collectively, ROSETTA Background Technology and ROSETTA Program
Technology.
1.64 ROSETTA
Tissue Samples”
means
the tissue or body fluid samples identified by ROSETTA and used by ROSETTA,
or
provided by ROSETTA for use, in the Development Program.
1.65 “Royalty
Term”
means,
with respect to each Collaboration Product or Collaboration Service in each
country in the Territory, the period beginning on the date of First Commercial
Sale of such Collaboration Product or Collaboration Service in such country
and
ending on the expiration of the last to expire Valid Claim in such country
that
covers such Collaboration Product or Collaboration Service or its manufacture
or
a method of its delivery or of its use.
1.66 “Sublicensee”
means
any Third Party (other than an Affiliate) to which AMBION grants a sublicense
in
accordance with Section 5.1.2. For purposes of clarity, a Sublicensee shall
not
include a Distributor (as defined in Section 5.1.3).
1.67 “Technology”
means,
collectively, all inventions, discoveries, improvements, trade secrets and
proprietary methods, whether or not patentable, including without limitation:
(a) methods of production or use of, and structural and functional information
pertaining to, chemical compounds and (b) data, formulations, processes,
techniques, know-how and results (including any negative results).
1.68 “Territory”
means
all countries of the world.
1.69 “Therapy”
means
the treatment or cure of a disease.
1.70 “Third
Party”
means
any party other than AMBION and ROSETTA and their respective
Affiliates.
1.71 “Tissue
Samples”
means
AMBION Tissue Samples and ROSETTA Tissue Samples.
1.72 “Validation
Method”
means
(a) sequencing analysis, (b) Northern blot analysis, (c) RT-PCR or (d) any
other
method mutually agreed to by the Parties.
1.73 “Valid
Claim”
means
any claim of an issued and unexpired patent or a pending patent application
within the ROSETTA Patent Rights, AMBION Patent Rights or Joint Program Patent
Rights that (a) has not been finally cancelled, withdrawn, abandoned or rejected
by any administrative agency or other body of competent jurisdiction, (b) has
not been permanently revoked, held invalid, or declared unpatentable or
unenforceable in a decision of a court or other body of competent jurisdiction
that is unappealable or unappealed within the time allowed for appeal, (c)
has
not been rendered unenforceable through disclaimer or otherwise, and (d) is
not
lost through an interference proceeding.
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
1.74 “Validated
xxXXX Sequence”
means
any xxXXX Sequence that has been shown through practice of a Validation Method
to be expressed in at least one tissue or cell type.
Additional
Definitions.
In
addition, each of the following definitions shall have the respective
meanings set forth in the section of this Agreement indicated
below:
Definition
|
Section
|
AMBION
Indemnitees
|
10.1
|
AMBION
Infringement
|
7.2.2(a)
|
Claims
|
10.1
|
Clinical
Development Stage
|
1.23
|
Discovery
Results Meeting
|
2.1.2(a)(ii)
|
Discovery
Stage
|
1.23
|
Disputed
Matter
|
11.1
|
Distributor
|
5.1.6
|
Filing
Party
|
7.1.4
|
Indemnified
Party
|
10.3
|
Indemnifying
Party
|
10.3
|
Infringement
Notice
|
7.2.1(a)
|
IPO
Share Purchase Right
|
5.1.5
|
Losses
|
10.1
|
Patent
Coordinator
|
6.2
|
Recipient
Party
|
2.1.2(f)
|
Restrictions
on Use
|
5.1.7
|
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.
00
XXXXXXX
Xxxxxxxxxxx
|
10.2
|
Sequence
Notice
|
2.1.2(b)
|
Sequence
Notification Period
|
2.1.2(b)
|
Term
|
8.1
|
Third
Party Infringement
|
7.2.1.
(a)
|
Third
Party Payments
|
3.1.1(c)
|
Transferring
Party
|
2.1.2(f)
|
Validating
Party
|
1.38
|
2. DEVELOPMENT
AND COMMERCIALIZATION OF PRODUCTS AND SERVICES
2.1 Development
Program
2.1.1 Objectives
of Development Program.
The
objectives of the Development Program shall be the identification and
Development of Collaboration Products and Collaboration Services for
Commercialization in the Field.
2.1.2 Conduct
of Development Program.
(a) Development
Plan.
(i) Mutual
Responsibilities of the Parties.
The
initial Development Plan covering the activities to be carried out by the
Parties under the Development Program commencing on the Effective Date is
attached hereto as Exhibit
A.
Unless
otherwise agreed, each Party shall conduct its activities in the Discovery
Stage
independently of the other Party and shall not be required to share any results
with the other Party until the Discovery Results Meeting. The Parties may,
by
mutual agreement, make adjustments and amendments to the Development Plan as
reasonably required during the Term of this Agreement, which adjustments and
amendments shall be attached as an addendum to Exhibit
A.
Each
adjustment and amendment to the Development Plan shall be in writing and shall:
(a) set forth (i) the activities to be performed with reasonable specificity;
(ii) the Party that shall be responsible for performing such activities; and
(iii) a timeline for such activities; and (b} be consistent with the terms
of
this Agreement. Each Party agrees to use commercially reasonable efforts to
perform its respective activities under the Development Plan, with the goal
of
identifying at least one (1) diagnostic use within the Field (such as early
detection, staging of tumor or response to a specific therapy) for Development
of a Collaboration Product or Collaboration Service. Without limiting the
foregoing, each party shall (A) commit such scientific resources, including,
but
not limited to, consultants, facilities, equipment, and Proprietary Materials,
as are reasonably necessary to achieve the objectives of the Development Program
and (B) perform its obligations under the Development Plan in good scientific
manner and in compliance in all material respects with all Applicable
Laws.
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.
11
(ii) Discovery
Results Meeting.
At the
conclusion of the Discovery Stage, but in no event later than 12 months after
the Effective Date, the Parties shall exchange data resulting from their
activities in the Discovery Stage and shall meet to determine the indications
to
be pursued in the Clinical Development Stage, the validation activities to
be
conducted in the Clinical Development Stage, and the responsibilities of the
Parties for such activities (the “Discovery Results Meeting”). The Development
Plan will be modified to reflect such matters.
(iii) Tissue
Sharing.
ROSETTA
and AMBION shall disclose to each other, at the Discovery Results Meeting and
thereafter, the Tissue Samples under each Party’s Control and any data
Controlled by such party with respect to such Tissue Samples in the event that
such data would be useful in accomplishing the objectives of the Development
Program. During the Clinical Development Stage, ROSETTA and AMBION shall provide
reasonable quantities of Tissue Samples, or portions thereof, to each other
upon
reasonable request, which Tissue Samples shall be solely for use in the
Development Program..
(iv) Specific
Responsibilities of ROSETTA.
Without
limiting the generality of Section 2.1.2(a)(i), in addition to any
responsibilities of ROSETTA set forth in the Development Plan, ROSETTA shall
(A)
disclose to AMBION any data Controlled by ROSETTA on the date of the Discovery
Results Meeting and thereafter with respect to the ROSETTA xxXXX Sequences
and
xxXXX Profiles that are related to the Tissue Samples used in the Development
Program; and (B) use commercially reasonable efforts to perform the expression
profiling activities, analysis of expression profiling results, identification
of differentially expressed xxXXX Sequences and identification of biomarkers
and
relevant patient populations described in the Development Plan with the goal
of
developing ROSETTA xxXXX Profiles that may be clinically evaluated by AMBION
during the Clinical Development Stage, using as many Tissue Samples as is
reasonably necessary to support the utility of such ROSETTA xxXXX Profiles
and/or the related ROSETTA xxXXX Sequences; provided, that, notwithstanding
the
foregoing, neither Party shall be obligated to analyze more than [***]
Tissue
Samples pursuant to the Discovery Phase of the Development Program. At the
Discovery Results Meeting ROSETTA shall disclose to AMBION the relevant ROSETTA
xxXXX Sequences and/or ROSETTA xxXXX Profiles. In addition, during the Clinical
Development Stage, ROSETTA shall use commercially reasonable efforts to perform
clinical evaluation of ROSETTA xxXXX Sequences and Public xxXXX Sequences and
ROSETTA xxXXX Profiles developed by ROSETTA pursuant to the Development Program
as described in the Development Plan.
(v) Specific
Responsibilities of AMBION.
Without
limiting the generality of Section 2.1.2(a)(i), in addition to any
responsibilities of AMBION set forth in the Development Plan, during the
Clinical Development Stage, AMBION shall (A) supply ROSETTA at AMBION’s expense
with the type and quantity of AMBION Tissue Samples as are set forth in the
Development Plan; (B) disclose to ROSETTA any data Controlled by AMBION with
respect to the xxXXX Profiles and ROSETTA xxXXX Sequences that are related
to
the Tissue Samples used in the Development Program; and (C) use commercially
reasonable efforts to perform clinical evaluation of ROSETTA xxXXX Sequences
and
Public xxXXX Sequences and ROSETTA xxXXX Profiles developed by ROSETTA pursuant
to the Development Program as described in the Development Plan.
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.
12
(b) Cooperation.
The
Parties acknowledge that the implementation of the Development Program will
require cooperation of the Parties and, in connection therewith agree to
cooperate in the performance of the Development, Program and, subject to Section
2.2(a) and the other terms of this Agreement and any confidentiality obligations
to Third Parties, shall exchange such data, information and materials as are
reasonably necessary for the other Party to perform its obligations under the
Development Plan.
(c) Records.
Each
Party shall maintain records of its activities under the Development Program
in
sufficient detail, in good scientific manner and otherwise in a manner that
reflects all work done and results achieved in the performance of the
Development Program. Without limiting the generality of this Section 2.1.2(c),
each Party agrees to maintain a policy that rewires its employees and
consultants to record and maintain all data and information developed during
the
Development Program in a manner designed to enable the Parties to use such
records to establish the earliest date of invention or reduction to
practice.
(d) Reports
and Data.
Subject
to Section 2.1.2(a), the Parties shall keep the JSC regularly informed of the
progress of the Development Program. Without limiting the generality of the
foregoing, (i) prior to the Discovery Results Meeting, no Confidential
Information or Technology that is not the subject of a patent or patent
application will be required to be provided, and (ii) after the Discovery
Results Meeting, the Parties shall, not less than once each Calendar Quarter
during the Term (and more frequently if required to keep the JSC sufficiently
informed), provide to the JSC (i) reports in reasonable detail regarding the
status of each Party’s activities under the Development Program and (ii) such
supporting data and information as may be reasonably requested from time to
time
by the JSC regarding the Development Program.
(e) Supply
of Proprietary Materials.
For the
purpose of facilitating the conduct of the Development Program, from time to
time during the Term after the Discovery Results Meeting, each Party (the
“Transferring Party”) shall supply the other Party (the “Recipient Party”), at
its sole expense, with Proprietary Materials of the Transferring Party for
use
in the Development Program as specified in the Development Plan. In connection
therewith, each Recipient Party hereby agrees that (a) it shall not use such
Proprietary Materials for any purpose other than exercising its rights or
performing its obligations hereunder; (b) it shall use such proprietary
Materials only in alliance with all Applicable Laws; (c) it shall not transfer
any such Proprietary Materials to any Third Party without the prior written
consent of the Transferring Party; except as expressly permitted hereby; (d)
the
Recipient Party shall not acquire any right, title or interest in or to such
Proprietary Materials as a result of such supply by the Transferring Party;
and
(e) upon the expiration or termination of the Term, the Recipient Party shall,
if and as instructed by the Party, either destroy or return any such Proprietary
Materials that are not the subject of the grant of a continuing license
hereunder.
2.2 Development
and Commercialization.
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.
13
2.2.1 Responsibility
for Development and Commercialization.
(a) Responsibilities
of AMBION.
Subject
to Section 2.4 and to ROSETTA’S obligations set forth in Section 2.2.1(b),
AMBION shall be responsible for Commercializing, Collaboration Products and
Collaboration Services in the Field in the Territory, including without
limitation (i) to the extent required, the preparation and filing of Regulatory
Filings and the seeking of Regulatory Approvals for Collaboration Products
and
Collaboration Services, as well as all associated official correspondence and
communications with Regulatory Authorities regarding such matters, (ii)
reporting to Regulatory Authorities any adverse experience and safety issues
for
Collaboration Products and Collaboration Services in compliance with the
requirements of Applicable Laws, and (iii) the conduct of (A) all activities
relating to the manufacture and supply of Collaboration Products and the
providing of Collaboration Services, and (ii) all marketing, promotion, sales,
distribution, import and export activities (including securing reimbursement,
sales and marketing and conducting any post-marketing trials or databases and
post-marketing safety surveillance). All activities related to the Development
and Commercialization of Collaboration Products and the providing of
Collaboration Services under this Agreement shall be undertaken at AMBION’S sole
cost and expense, except as expressly provided in this Agreement.
(b) Responsibilities
of ROSETTA.
Notwithstanding anything to the contrary in Section 2.2.1(a), ROSETTA hereby
agrees to perform the market development activities in support of Collaboration
Products and Collaboration Services described on Schedule 4
attached
hereto and incorporated herein by reference.
2.2.2 Diligence.
AMBION
will exercise commercially reasonable efforts in Developing and Commercializing
Collaboration Products and Collaboration Service, and in undertaking actions
required to obtain appropriate Regulatory Approvals necessary to market
Collaboration Products and Collaboration Services in the Field throughout the
Territory, such commercially reasonable efforts to be in accordance with the
efforts and resources an established diagnostic company would use for a product
owned by it or to which it has rights, which is of similar market potential
at a
similar stage in development as the applicable Collaboration Product or
Collaboration Service, taking into account the proprietary position of the
Collaboration Product or Collaboration Service, the relative potential efficacy
of the Collaboration product or Collaboration Service, the regulatory
requirements involved in its Development and Commercialization, the cost of
goods and availability of capacity to manufacture and supply the, Collaboration
Product and provide the Collaboration Service at commercial scale, and other
relevant factors.
2.3 Information
Updates.
2.3.1 Updates
and Reports.
In
addition to reports to the JSC regarding the Development Program pursuant to
Section 2.1(d), AMBION shall keep ROSETTA reasonably informed regarding the
progress of AMBION’s efforts to Develop and Commercialize Collaboration Products
and/or Collaboration Services in the Field and in the Territory by providing
ROSETTA with quarterly reports which shall (a) summarize AMBION’s efforts to
Develop and Commercialize Collaboration Products and/or Collaboration Services,
and (b) identify the Regulatory Filings with respect to such Collaboration
Products and/or Collaboration Services that AMBION or any of its Affiliates
or
Sublicensees have filed, sought or obtained in the prior Calendar Quarter or
reasonably expect to make, seek or attempt to obtain in the following Calendar
Quarter.
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.
14
2.3.2 Adverse
Event Information.
In
addition to the updates described in Section 2.3.1, AMBION shall provide ROSETTA
with copies of all adverse and product complaint information relating to
Collaboration Products and/or Collaboration Services as such information is
compiled or prepared by AMBION in the normal course of business in connection
with the Development or Commercialization of any Collaboration Product and/or
Collaboration, Service and, in any event, within time frames consistent with
reporting obligations under Applicable Laws.
2.3.3 Preparation
of Regulatory Filings.
AMBION
shall consult with ROSETTA in good faith in connection with the preparation
of
all Regulatory Filings for Collaboration Products and Collaboration Services.
AMBION shall consider all comments of ROSETTA in good faith, taking into account
the best interests of the Collaboration and of the Development and
Commercialization of the applicable Collaboration Product and/or Collaboration
Service on a global basis. In addition, subject to any Third Party
confidentiality obligations, AMBION shall promptly provide ROSETTA with copies
of any document or other correspondence received from the FDA pertaining to
any
Collaboration product and/or Collaboration Service.
2.4 Joint
Steering Committee.
2.4.1 Establishment.
ROSETTA
and AMBION hereby establish the Joint Steering Committee to serve as a forum
for
coordination and communication between the Parties with respect to the
Development Program and in connection with the Development and Commercialization
by AMBION of Collaboration Products and Collaboration Services. The JSC shall
serve solely as a forum for such, coordination and communication and shall
not
have any authority to make decisions.
2.4.2 Membership.
Each of
ROSETTA and AMBION shall designate an equal (not less than two (2)) number
of
representatives to the JSC (which may be employees of, or consultants to, such
Party). Unless otherwise agreed by the Parties, one of AMBION’s representatives
shall be designated as the Chairman of the JSC. Each Party shall have the right
at any time to substitute individuals on a permanent or temporary basis, for
any
of its previously designated representatives to the JSC by giving written notice
to the other Party.
2.4.3 Meetings.
(a) Schedule
of Meetings; Agenda.
The JSC
shall establish a schedule of times or regular meetings, taking into account,
without limitation, the planning needs of the Collaboration. In addition,
special meetings may be convened by any member of the JSC upon thirty (30)
days
(or, if such meeting is proposed to be conducted by teleconference, upon ten
(10) days) written notice to the other members. In no event shall the JSC meet
less frequently than four (4) times in each Calendar Year. Regular and special
meetings of the JSC may be held in person or by teleconference or
videoconference; provided that meetings held in person shall alternate between
the respective offices of the Parties in Austin, Texas and Rehovot, Israel
or
such other locations mutually agreeable to the JSC members. The Chairman shall
have the responsibility for preparing and circulating to each JSC member an
agenda for each JSC meeting not later than one (1) week prior to such
meeting,
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.
15
(b) Minutes.
The JSC
shall keep minutes of its meetings that record its discussions and decisions
in
reasonable detail. Drafts of the minutes shall be prepared and circulated to
the
members of the JSC within a reasonable time after the meeting, not to exceed
ten
(10) business days, and the Parties shall alternate responsibility for the
preparation and circulation of draft minutes. Each member of the JSC shall
have
the opportunity to provide comments on the draft minutes. Draft minutes shall
be
approved, disapproved and revised as necessary at the next JSC meeting. Upon
approval, final minutes of each meeting shall be circulated to the members
of
the JSC by the Chairman.
(c) Expenses.
ROSETTA
and AMBION shall each bear all expenses of their respective JSC representatives
related to their participation on the JSC and attendance at JSC
meetings.
3. CONSIDERATION
3.1 Payment
of Royalties; Royalty Rates; Accounting and Records.
3.1.1 Payment
of Royalties.
(a) Royalty
Rates.
AMBION
shall pay ROSETTA a royalty based on Annual Net Sales of each Collaboration
Product and Collaboration Service commencing with the Calendar Year (or partial
Calendar Year) in which the First Commercial Sale of such Collaboration Product
or Collaboration Service occurs and ending upon expiration of the Royalty Term
for such Collaboration Product and Collaboration Service, at the following
rates:
Annual
Net Sales
|
Royalty
Rate
|
Up
to and including $[***] million
|
[***]%
|
Above
$[***] million and up to and including $[***] million
|
[***]%
|
Above
$[***] million and up to and including $[***] million
|
[***]%
|
Above
$[***] million and up to and including $[***] million
|
[***]%
|
Above
$[***] million
|
[***]%
|
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.
16
For
purposes of clarity, for example, if Annual Net Sales are equal to $[***]
million, the royalty payment under this Agreement shall be $[***] million
([***]% of $[***]million, plus [***]% of $[***] million, plus [***]% of $[***]
million). The applicable royalty rates will apply per product and the quantity
of Annual Net Sales for each such product will be calculated separately for
each
Calendar Year.
(b) Payment
Dates and Reports.
Royalty
payments shall be made by AMBION within thirty (30) days after the end of each
Calendar Quarter commencing with the Calendar Quarter in which the First
Commercial Sale of each Collaboration Product and/or Collaboration Service
occurs. All payments shall be made by wires transfer to the credit of such
bank
account as shall be designated in writing from time to time by ROSETTA. ROSETTA
shall designate a suitable account within thirty (30) days of the Effective
Date. AMBION shall also provide, at the same time each such payment is made,
a
report showing: (i) the Net Sales of each Collaboration Product and
Collaboration Service by country in the Territory; (ii) the basis for any
deductions from gross amounts billed or invoiced to determine Net Sales; (iii)
the applicable royalty rates for such Collaboration Product and Collaboration
Service; (iv) the exchange rates used in calculating any of the foregoing;
and
(v) a calculation of the amount of royalty due to ROSETTA.
3.1.2 Records:
Audit Rights.
AMBION
and its Affiliates and Sublicensees shall keep and maintain for three (3) years
from the date of each payment of royalties hereunder complete and accurate
records of their respective gross sales and Net Sales by AMBION and its
Affiliates and Sublicensees in sufficient detail to allow royalties to be
determined accurately. ROSETTA shall have the right for a period of three (3)
years after receiving any such payment to appoint at its expense an independent
certified public accountant reasonably acceptable to AMBION to inspect or audit
he relevant records of AMBION and its Affiliates and Sublicensees solely to
verify that the amount of such payment was correctly determined. AMBION, its
Affiliates and Sublicensees shall each make its records available for inspection
or audit by such independent certified public accountant during regular business
hours at such place or places where such records are customarily kept, upon
reasonable notice from ROSETTA, solely to verify that royalty payments hereunder
were correctly announced for or determined. Such inspection or audit right
shall
not be exercised by ROSETTA more than once in any Calendar Year or more than
once with respect to sales of a particular Collaboration product or
Collaboration Service in a particular period, whichever is less frequent. All
records made available for inspection or audit shall be deemed to be
Confidential Information of AMBION and, at AMBION’s request, the accountant
shall enter into a confidentiality agreement with both Parties substantially
similar to Section 4.1 limiting the disclosure and use of such information.
The
result of each inspection or audit, if any, shall be binding on both Parties.
In
the event there was an underpayment by AMBION hereunder, AMBION shall promptly
(but in any event no later than thirty (30) days after AMBION’s receipt of the
independent accountant’s report so concluding) make payment to ROSETTA of any
shortfall. In the event that there was an overpayment by AMBION’s hereunder,
ROSETTA shall promptly (but in any event no later than thirty (30) days after
ROSETTA’s receipt of the independent accountant’s report so concluding) refund
to AMBION the excess amount. ROSETTA shall bear the full cost of such audit
unless such audit discloses an underreporting by AMBION of more than [***]
percent ([***]%) of the aggregate amount of royalties payable in any Calendar
Year, in which case AMBION shall reimburse ROSETTA for all costs incurred by
ROSETTA in connection with such inspection or audit.
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.
17
3.1.3 Overdue
Royalties.
All
royalty payments not made within the time period set forth in Section 3.1.1
shall bear interest at a rate of [***] percent ([***]%) per month from the
due
date until paid in full or, if less, the maximum interest rate permitted by
Applicable Laws. Any such overdue royalty shall, when made, be accompanied
by,
and credited first to, all interest so accrued.
Withholding
Taxes.
Withholding tax, if any, levied by a government of any country of the on
payments made by AMBION to ROSETTA hereunder or any part thereof according
to
the relevant law shall be borne by ROSETTA. AMBION will pay such withholding
tax, to the respective taxing authorities and will deduct such amount front
the
royalty due to ROSETTA. AMBION shall use its best efforts to enable ROSETTA
to
claim exception there from under any double taxation or similar agreement in
force and shall produce to ROSETTA proper evidence of payments of all
withholding taxes. Notwithstanding the foregoing, ROSETTA represents and
warrants that ROSETTA’s tax documentation, including, but not limited to its
W-9, on file with AMBION as of the Effective Date is accurate.
3.1.4 All
payments made by AMBION hereunder shall be free and clear of any taxes, duties,
levies, fees or charges except for applicable withholding taxes, if any. AMBION
shall make any applicable withholding payments due from ROSETTA on its behalf
and shall promptly thereafter provide ROSETTA with written documentation of
any
such payment sufficient to enable ROSETTA to satisfy the requirements of any
taxing authority with regard to an application for a foreign tax credit for
such
payment.
3.1.5 Foreign
Currency Exchange.
All
royalty payments shall be payable in full in United States Dollars, regardless
of the countries in which sales are made. For the purpose of computing Net
Sales
for Collaboration Products or Collaboration Services in any currency other
than
United States Dollars, the quarterly royalty payment will be calculated as
follows:
(A/B)
x C
= United States Dollars royalty payment on Net Sales sold in any currency other
than United States Dollars during a Calendar Quarter, where
A=
foreign “Net Sales” (as defined above) in such Calendar Quarter expressed in
such foreign currency;
B=
foreign exchange conversion rate, expressed in local currency of the foreign
country per United States Dollar (using, as the applicable foreign exchange
rate, the daily rate of exchange set forth on the web site xxx.xxxxx.xxx
or, to
the extent the web site is not available, as published in the Wall Street
Journal); and
C=
the
royalty rate(s) applicable to such Net Sales under this Agreement.
3.1.6 Acknowledgement.
AMBION
recognizes and acknowledges that each of the following, separately and together,
has substantial economic benefit to AMBION: (i) ROSETTA’s expertise concerning
the discovery and understanding of miRNAs; (ii) the performance by ROSETTA
of
the Development Program; (iii) the disclosure to AMBION of results obtained
in
the Development Program by ROSETTA; (iv) the licenses granted to AMBION
hereunder with respect to ROSETTA Technology and Joint Technology are not within
the claims of any Patent Rights Controlled by ROSETTA; (v) the licenses granted
to AMBION under Patent Rights Controlled by ROSETTA; and (vi) the exclusivity
afforded to AMBION by each of the foregoing the Parties agree that the royalty
rates set forth in Section 3.1.1 reflect a fair and reasonable blended
allocation of the values provided by ROSETTA to AMBION, regardless of whether,
any particular Collaboration Product or Collaboration Service contains or uses
one or more ROSETTA miRNAs.
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.
18
3.2 Sublicense
Income.
In the
event that AMBION grants a sublicense to a Third Party that is not an Affiliate
in accordance with Section 5.1.2, the Parties shall negotiate in good faith
the
consideration to be paid to ROSETTA as a result of each such
sublicense.
4. TREATMENT
OF CONFIDENTIAL INFORMATION;
PUBLICITY
NON-SOLICITATION.
4.1 Confidentiality.
4.1.1 Confidentiality
Obligations.
ROSETTA
and AMBION each recognizes that the other Party’s Confidential Information and
Proprietary Materials constitute highly valuable assets of such other Party.
ROSETTA and AMBION each agrees that, subject to Section 4.1.2, during the Term
and for an additional five (5) years thereafter, it will not disclose, and
will
cause its Affiliates and sublicensees not to disclose, any Confidential
Information or Proprietary Materials of the other Party. In addition, each
Party
agrees that it will not use, and will cause its Affiliates not to use, any
Confidential Information or Proprietary Materials of the other Party except
as
expressly permitted hereunder. Without limiting the generality of the foregoing,
each Party shall take such action, and shall cause its Affiliates and
sublicensees to take such action, to preserve the confidentiality of the other
Party’s Confidential Information and Proprietary Materials as such Party would
customarily take to preserve the confidentiality of its own Confidential
Information and Proprietary Materials.
4.1.2 Limited
Disclosure.
ROSETTA
and AMBION each agrees that disclosure of its Confidential Information or any
transfer of its Proprietary Materials maybe made by the other Party to any
employee, consultant or Affiliate of such other Party to enable such other
Party
to exercise its rights or to carry out its responsibilities under this
Agreement; provided that any such disclosure or transfer shall only be made
to
Persons who are bound by the written obligations as described in Section 4.13.
In addition, ROSETTA and AMBION each agrees that the other Party may disclose
its Confidential Information (a) on a need-to-know basis to such other Party’s
legal and financial advisors, (b) as reasonably necessary in connection with
an
actual or potential (i) permitted sublicense of such ether Party’s rights
hereunder, (ii) debt or equity financing of such other Xxxxx or (iii) permitted
assignment of this Agreement pursuant to Section 12.9 involving such other
Party
and (c) if the Person receiving such Confidential Information or Proprietary
Materials of the other Party agrees in writing to maintain the confidentiality
of such Confidential Information or Proprietary Materials of the other Party
with terms at least as restrictive as those contained in Section 4.1.1. In
addition, each Party agrees that the other Party may disclose such Party’s
Confidential Information or Proprietary Materials (A) as reasonably necessary
to
file, prosecute or maintain Patent Rights, or to file, prosecute or defend
litigation related to Patent Rights, in accordance with this Agreement; or
(B)
as required by Applicable Laws; provided that; in the case of any disclosure
under this clause (B) the disclosing Party shall (1) if practicable, provide
the
other Party with reasonable advance notice of and an opportunity to comment
on
any such required disclosure, (2) if requested by such other Party, seek, or
cooperate in all reasonable respects with such other Party’s efforts to obtain,
confidential treatment or a protective order with respect to any such disclosure
to the extent available at such other Party’s expense, and (3) use good faith
efforts to incorporate the comments of such other Party in any such disclosure
or request for confidential treatment or protective order.
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.
19
4.1.3 Employees
and Consultants.
ROSETTA
and AMBION each hereby represents that all of its employees and consultants,
and
all of the employees and consultants of its Affiliates, who participate in
the
activities of the Collaboration or (except for routine maintenance or cleaning
staff) have access to Confidential Information or Proprietary Materials of
the
other Party are or will, prior to their participation or access, be bound by
written obligations to maintain such Confidential Information or Proprietary
Materials in confidence and not to use such information except as expressly
permitted hereunder. Each Party agrees to use, and to cause its Affiliates
to
use, reasonable efforts to enforce such obligations.
4.2 Publicity.
The
Parties acknowledge that the terms of this Agreement constitute Confidential
Information of each Party and may not be disclosed except as permitted by
Section 4.1.2. Notwithstanding anything to the contrary in Section 4.1, (i)
either Party may disclose the existence of this Agreement and the nature and
scope of the Collaboration, and (ii) the Parties, upon the execution of this
Agreement, shall mutually agree to a press release with respect to this
Agreement and, once such press release is approved for disclosure by both
parties, either Party may make subsequent public’ disclosure of the contents of
such press release without further approval of the other Party. Thereafter,
neither Party shall publish, present or otherwise disclose publicly any material
related to the Development Program or to the Development or the
Commercialization of a Collaboration Product or Collaboration Service without
the prior written consent of the other Party.
4.3 Publications
and Presentations.
The
Parties acknowledge that scientific publications must be strictly monitored
to
prevent any adverse effect from premature publication or dissemination of
results of the activities hereunder. Except as required by Applicable Laws,
each
Party agrees that it shall not publish or present, or permit to be published
or
presented, the results of the Development Program or the Development or
Commercialization of a Collaboration Product or Collaboration Service, including
but not limited to, studies or clinical trials carried out by such Party as
part
of the Collaboration under this Agreement, without the prior review by and
the
approval of the other Party. Each Party shall provide to the other Party the
opportunity to review any of the submitting Party’s proposed abstracts,
manuscripts or presentations (including information to be presented verbally)
which relate to the Development Program or the Development or the
Commercialization of a Collaboration Product or Collaboration Service at least
thirty (30) days prior to its intended presentation or submission for
publication, and such submitting Party agrees, upon written request from the
other Party within such thirty (30) day period, not to submit such abstract
or
manuscript for publication or to make such presentation until the other Party
is
given up to sixty (60) days from the date of such written request to seek
appropriate patent protection for any material in such publication or
presentation which the other Party reasonably believes is patentable. Once
such
abstracts, manuscripts or presentations have been reviewed by the other Party,
the same abstracts, manuscripts or presentations do not have to be provided
again, to the either Party for review for a later submission for publication.
Each Party also shall have the right to require that its Confidential
Information that is disclosed in any such proposed publication or presentation
be deleted prior to such publication or presentation. In any permitted
publication or presentation by a Party, the other Party’s contribution shall be
duly recognized and co-authorship shall be determined in accordance with
customary industry standards.
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.
20
4.4 Prohibition
on Solicitation.
Without
the written consent of the other Party, neither Party nor its Affiliates shall,
for a period of five (5) years from the Effective Date, solicit (directly or
indirectly) any employee of the other Party or its Affiliates who participated
in the Development Program at anytime. This provision shall not restrict either
Party or its Affiliates from advertising employment opportunities in any manner
that does not directly target the other Party or its Affiliates.
5. LICENSE
GRANTS; RESTRICTIONS ON USE
5.1 Grant
of Rights to AMBION.
5.1.1 License
Grant. Subject to the other terms, of this Agreement (including without
limitation Section 5.1.4), ROSETTA hereby grants to AMBION during the Royalty
Term an exclusive (as to all Third Parties and as to ROSETTA), royalty-bearing
license, including the right to grant sublicenses as described in Section 5.1.2,
under the Licensed Technology and the Licensed Patent Rights (a) to Develop
Collaboration Products and Collaboration Services under the Development Program
in accordance with the Development Plan for use in the Field; and (b) to
Commercialize and have Commercialized Collaboration Products and Collaboration
Services for use in the Field and in the Territory. For purposes of clarity,
it
is acknowledged that the use by ROSETTA of the Licensed Technology and Licensed
Patent Rights, including without limitation, ROSETTA xxXXX Sequences, and all
Collaboration Products in (a) its own research and product development
activities, (b) academic collaborations, and (c) collaborations with Third
Party
commercial entities to discover, develop and commercialize therapeutic or
diagnostic products and/or services outside the Field shall not be deemed to
be
Development or Commercialization of Collaboration Products or Collaboration
Services.
5.1.2 Right
to Sublicense.
AMBION
shall have the right to grant to sublicenses under the license granted to it
under Section 5.1.1 to any Affiliate or Third Party; provided, that (a) AMBION
shall have obtained the prior written approval of ROSETTA to each such
sublicense to a Third Party, (b) it shall be a condition of any such sublicense
that such Sublicensee agrees in writing with ROSETTA to be bound by (i) all
terms of this Agreement applicable to the Commercialization of Collaboration
Products and Collaboration Services in the Field in the Territory (including,
without limitation, Article 4) and (ii) the Restrictions on Use set forth on
Schedule 5 attached hereto as described in Section 5.1.4; and (c) AMBION shall
not be relieved of any of its obligations pursuant to this Agreement as a result
of such sublicense.
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.
21
5.1.3 Appointment
of Distributors.
AMBION
shall have the right to appoint one or more Third Parties within AMBION’s normal
chain of distribution to act as distributors of Collaboration Products (each,
a
“Distributor”), provided, that, any sale or transfer for value of a
Collaboration Product to such Distributor shall be included in the definition
of
Net Sales at the transfer price to the Distributor in the event of a transfer
for value.
5.1.4 Restrictions;
Labeling
(a) Restrictions
on Use.
AMBION
shall include with all Collaboration Products sold by it or any; Affiliate
to
any Third Party, and shall require any Sublicensee or Distributor to include
with respect to all Collaboration Products sold by such Sublicensee or
Distributor the restrictions on use substantially in the form set forth in
Schedule 5, attached hereto (the “Restrictions on Use”). AMBION agrees to
include such Restrictions on Use with Collaboration Products according to the
same, standards that AMBION provides similar license restrictions on products
sold by AMBION. In the event that AMBION becomes aware of additional
requirements that are needed to enforce the Restrictions on Use, AMBION agrees
to notify ROSETTA of such requirements, and the Parties shall mutually agree
on
revised language to be included in Schedule
5.
(b) Notice
of Breach.
If at
any time during the Term, AMBION has knowledge that a Third Party purchaser
of a
Collaboration Product is breaching the Restrictions on Use, AMBION shall
promptly notify ROSETTA, and the Parties shall mutually agree on how to address
such Third Xxxxx breach.
(c) Labelling.
In
addition to the Restrictions on Use, AMBION shall include on the packaging
of
Collaboration Products any additional language and/or graphics reasonably
requested by ROSETTA in the form provided by ROSETTA (including without
limitation language that discloses that the applicable Collaboration Product
incorporates ROSETTA Technology), the exact wording and/or design of which
to be
determined by mutual agreement of the Parties at the time of Commercialization
of each such Collaboration Product.
5.1.5 Use
of
Results.
AMBION
shall have the right to use or incorporate the ROSETTA Results in patent
applications (or the prosecution thereof) pertaining to XXXXXX xxXXX Sequences
but only to the extent necessary or useful to support claims solely owned by
AMBION and in which ROSETTA has no ownership interest.
5.2 Grant
of Rights to ROSETTA.
5.2.1 License
Grant.
Subject
to the ether terms of this Agreement. AMBION hereby grants to ROSETTA and its
Affiliates during the Term, a personal, non transferable royalty-free license,
without the right to grant sublicenses, under AMBION Technology and AMBION
Patent Rights and AMBION’s interest in Joint Program Technology and Joint
Program Patent Rights for the sole purpose of fulfilling its obligations under
the Development Program in accordance with the Development Plan.
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.
22
5.2.2 Use
of
Results.
ROSETTA
shall have the right to use or incorporate the AMBION Results in patent
applications (or the prosecution thereof) pertaining to ROSETTA xxXXX Sequences
but only to the extent necessary or useful to support claims solely owned by
ROSETTA and in which AMBION has no ownership interest
5.2.3 No
Other Rights.
Except
as expressly set forth herein, AMBION shall have no rights to use or otherwise
exploit ROSETTA Technology, ROSETTA Patent Rights or ROSETTA Materials
(including without limitation ROSETTA xxXXX Sequences or ROSETTA xxXXX
Profiles).
6. INTELLECTUAL
PROPERTY R.IGHTS
6.1 Disclosure
of Inventions.
Each of
ROSETTA and AMBION shall promptly provide the other Party through the Patent
Coordinators with written notice concerting all Program Inventions that are
conceived or reduced to practice in the conduct of the Development Program
by
employees or consultants of either of them or their Affiliates, alone or jointly
with employees or consultants of the other Party or its Affiliates. The Parties
shall, through the Patent Coordinators, amend Schedule 2
from
time to time during the Term to list any Program, Inventions that are Licensed
Patent Rights.
6.1.1 ROSETTA
Intellectual Property Rights.
ROSETTA
shall have sole and exclusive ownership of all right, title and interest on
a
worldwide basis in and to any and all ROSETTA Technology and ROSETTA Patent
Rights, subject to the rights of, and the licenses granted to, AMBION as set
forth herein.
6.1.2 AMBION
Intellectual Property Rights.
AMBION
shall have sole and exclusive ownership of all right, title and interest on
a
worldwide basis in and to any and all AMBION Technology and AMBION Patent
Rights, subject to the rights of, and the licenses granted to, ROSETTA as set
forth herein.
6.1.3 Joint
Program Technology Rights.
AMBION
and ROSETTA shall jointly own all Joint Program Technology and Joint Program
Patent Rights, subject to the rights of, and the licenses granted to, each
Party
hereunder. Notwithstanding anything to the contrary contained herein or under
Applicable Law, the Parties hereby agree that either Party may use or license
or
sublicense to Affiliates or Third Parties all or any portion of its interest
in
Joint Program Technology or Joint Program Patent Rights for any purposes outside
the Field and the Prostate Cancer Therapeutic Field without the prior written
consent of the other Party, without restriction and without the obligation
to
provide compensation to the other Party. Within the Field, only AMBION shall
have the right to use, license or sublicense any interest in the Joint Program
Technology, subject to Section 5.1.2. Within the Prostate Cancer Therapeutic
Field, either Party may use or license or sublicense to Affiliates or Third
Parties all or any portion of its interest in Joint Program Technology or Joint
Program Patent Rights; provided that (i) [***] percent ([***]%) of license
fees
and royalties from any license or sublicense of such Joint Technology by itself
(and without any license to any other Technology or Patent Rights of the
licensing Party) shall be paid to the licensing Party and [***] percent ([***]%)
shall be paid to the other Party; and (ii) [***] percent ([***]%) of license
fees and royalties from any licenses or sublicenses of Joint Program Technology
or Joint Program Patent Rights in combination with other Technology or Patent
Rights of the licensing Party, shall be allocated to the licensing Party and
[***] percent ([***]%) shall be allocated to the other Party.
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.
23
6.2 Patent
Coordinators.
ROSETTA
and AMBION shall each appoint a patent coordinator (each, a “Patent
Coordinator”), who shall serve as such Party’s primary liaison with the other
Party on matters relating to patent filing, prosecution, maintenance and
enforcement. Each Party may replace its Patent Coordinator at any time by notice
in writing to the other Party.
6.3 Inventorship.
In case
of a dispute between ROSETTA and AMBION over inventorship, such dispute shall
be
resolved by application of United States patent law by patent counsel selected
by the JSC who (and whose firm) is not at the time of the dispute, and was
not
at an time during the five (5) years prior to such dispute, performing services
for either of the Parties. Expenses of such patent counsel shall be shared
equally by the Parties.
7. FILING,
PROSECUTION AND MAINTENANCE OF PATENT RIGHTS
7.1 Patent
Filing, Prosecution and Maintenance.
The
responsibility for filing, prosecution and maintaining Patent Rights shall
be as
follows:
7.1.1 ROSETTA
Patent Rights.
ROSETTA, acting through patent counsel of its choice, shall be responsible,
at
its sole expense, for the preparation, filing, prosecution and maintenance
of
all ROSETTA Patent Rights. At ROSETTA’s request, AMBION shall cooperate with
ROSETTA in all reasonable respects in connection with such preparation, filing,
prosecution and maintenance of ROSETTA Patent Rights and Development Stage
Patent Rights.
7.1.2 AMBION
Patent Rights.
AMBION,
acting through patent counsel of its choice, shall be responsible, at its own
expense, for the preparation, filing, prosecution and maintenance of all AMBION
Patent Rights. At AMBION’s request, ROSETTA shall cooperate, with and assist
AMBION in all reasonable respects, at AMBION’s expense, in connection with such
preparation, filing, prosecution and maintenance of AMBION Patent
Rights.
7.1.3 Joint
Program Patent Rights.
The
Parties will cooperate through their respective Patent Coordinators to jointly
select outside patent counsel to handle the filing, prosecution and maintenance
of patents and patent applications claiming Joint Program Technology. ROSETTA
shall control the prosecution of patent applications claiming inventions that
are Joint Program Technology provided that, in addition to the provisions of
Section 7.1.4, ROSETTA shall not take any action to amend or abandon any claim
in a manner which would reduce the scope of coverage in the Field without the
consent of AMBION, not to be unreasonably withheld, without affording AMBION
the
opportunity to retain such claim. The fees of counsel and the other costs and
expenses related to patents and patent applications shall be shared equally
by
the Parties. Should one Party desire not to share in the cost of any such patent
or patent applications, the other Party shall gain sole control of the filing,
prosecution or maintenance of such patents or patent applications, which shall
be deemed to be the Program Technology of such Party and such Party shall have
sole responsibility for filing, prosecution or maintenance expenses with respect
thereto.
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.
24
7.1.4 Information
and Cooperation.
Except
as otherwise provided herein, each Party responsible for the filing of the
filing, prosecution and maintenance of Patent Rights under this Section 7.1
(the
“filing Party”) shall (a) regularly provide the other Party with copies of all
patent applications filed hereunder and other material submissions and
correspondence with the patent offices, in sufficient time to allow for review
and comment by the other Party and (b) provide the other Party and its patent
counsel with an opportunity to consult with the filing Party and its patent
counsel regarding the filing and contents of any such application, amendment,
submission or response. The filing Party hereby agrees that the advice and
suggestions of the other Party and its patent counsel shall be taken into
reasonable consideration by the filing Party and its patent counsel in
connection with each filing. Each Party shall, upon request from the filing
Party and at the filing Party’s sole cost, reasonably cooperate with the filing
Party in connection with such patent filing activities.
7.1.5 Assignment
of Patents.
The
assignment of any Patent Right under this Agreement shall include the right
to
enforce and collect damages for infringement of such Patent Right.
7.2 Legal
Actions.
7.2.1 Third
Party Infringement.
(a) Infringement.
In the
event either Party becomes aware of any possible infringement in the field
of
any ROSETTA Patent Rights, AMBION Patent Rights or Joint Program Patent Rights
(a “Third Party Infringement”), that Party shall promptly notify the other Party
and provide it with all details of such Third Party Infringement of which it
is
aware (each an “Infringement Notice”). ROSETTA shall have the first right and
option, but not the obligation, to eliminate any such Third Party Infringement
of ROSETTA Patent Rights within the Field, and AMBION shall have the first
right
and option, but not the obligation, to eliminate any Third Party Infringement
of
AMBION Patent Rights and/or of Joint Program Patent Rights within the Field,
in
any case, by taking reasonable steps, which may include the institution of
legal
proceedings; or the taking of other actions. All costs, including, without
limitation, attorneys’ fees, relating to such legal proceedings or other actions
shall be borne by the Party that assumes such obligation as described above.
If
ROSETTA does not take commercially reasonable steps to eliminate any Third
Party
Infringement of ROSETTA Patent Rights within three (3) months and such Third
Party Infringement relates to the Field, then AMBION shall have the right and
option to do so at its expense. AMBION does not take commercially reasonable
steps to eliminate any Third Party Infringement of Joint Program Patent Rights
within three (3) months and such Third Party Infringement relates to the Field,
then ROSETTA shall have the right and option to do so at its expense. Neither
Party shall settle any Third Party Infringement claim or proceeding under this
Section 7.2.1(a) without the prior written consent of the other Party, which
consent shall not be unreasonably withheld, conditioned or delayed.
(b) ParticipationEach
Party shall have the right to participate, and be represented by counsel that
it
selects, in any legal proceedings or other action instituted under this Section
7.2.1 by the other Party. If a Party with the right to initiate legal
proceedings under Section 7.2.1 to eliminate a Third Party Infringement lacks
standing to do so and the other Party has standing to initiate such legal
proceedings, then the Party with standing shall initiate such legal proceedings
at the request and expense of the other Party.
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.
25
(c) Joint
Program Patent Rights.
In the
event of a Third Party Infringement of a Joint Program Patent Right outside
the
Field, the Parties shall enter into discussions as to whether and how to
eliminate such Third Party Infringement. Each Party shall bear an equal share
of
the cost of any action, suit or proceeding instituted under this Section
7.2.1(c). An equal share of all amounts recovered shall be received by each
party. If the Parties are unable to determine whether and how to institute
an
action, suit or proceeding for Third Party Infringement of any such Joint
Program Patent Right in the Diagnosis of any disease other than Prostate Cancer,
either Party shall have the right to prosecute such Third Party Infringement,
in
which event that Party shall hear all of the expense and be entitled to retain
all amounts that it recovers. If the Parties are unable to determine whether
and
how to institute an action, suit or proceeding for Third Party Infringement
of
any such Joint Program Patent Right in the Therapy of any disease or any other
use of Joint Program Patent Rights, ROSETTA shall have the right to Prosecute
such Third Party Infringement, in which event ROSETTA shall bear all of the
expense and be entitled to retain all amounts that it recovers. Each Party
shall
have the right to be represented by counsel of its own selection in any action,
suit or proceeding instituted under this Section 7.2.1(c) by the other Party.
If
a Party lacks standing and the other Party has standing to bring any such
action, suit or proceeding, then the Party with standing shall bring such suit
at the at the request and expense of the other Party.
(d) Cooperation.
In any
action, suit or proceeding instituted under this Section 7.2.1, the Parties
shall cooperate with and assist each other in all reasonable respects. Upon
the
reasonable request of the Party instituting such action, suit or proceeding,
the
other Party shall join therein and shall be represented using counsel of its
own
choice, at the requesting Party’s expense.
(e) Recovery.
Any
amounts recovered-by ROSETTA pursuant to actions under Section 7.2.1(a) shall
be
allocated in the following order: (i) first, to reimburse ROSETTA and AMBION
for
their reasonable out-of-pocket expenses in making such recovery (which amounts
shall be allocated pro rata if insufficient to covert the totality of such
expenses); and (ii) then, 100% to ROSETTA. Any amounts recovered by AMBION
pursuant to Section 7.2.1(a), whether by settlement or judgment, shall be
allocated in the following order: (i) first, to reimburse AMBION and ROSETTA
for
their reasonable out-of-pocket expenses in making such recovery (which amounts
shall be allocated pro rata if insufficient to cover the totality of such
expenses); and (ii) then, to AMBION and ROSETTA in the same proportion as
AMBION’s historic profits on Net Sales of the Collaboration Product or
Collaboration Service affected by the Third Party Infringement bears to
ROSETTA’s historic royalties hereunder in respect of such Net Sales, in each
case as determined in good faith.
7.2.2 Defense
of Claims.
(a) Potential
Infringement by AMBION.
In the
event that either Party becomes aware that the use in the Field by AMBION of
any
ROSETTA xxXXX Sequence or Public xxXXX Sequence infringes or may infringe the
Patent Rights of a Third Party by reason of the conduct of the Development
Program, or the Development or the Commercialization of any Collaboration
Product or Collaboration Service (an “ANIBION Infringement”), AMBION may, in its
discretion, at its cost and expense, (i) negotiate and enter into a license
agreement or other arrangement with such Third Party to secure the necessary
rights to patent(s) and/or patent application(s) owned by such Third Party
which
in AMBION’s reasonable opinion would present an issue of infringement by reason
of AMBION ‘s manufacture, having manufactured, use, having used, offer for sale,
sale, exportation or importation of a Collaboration Product or Collaboration
Service, (ii) remove the infringing ROSETTA xxXXX Sequence or Public xxXXX
Sequence from the Collaboration Product or Collaboration Service, or (iii)
terminate sale of the Collaboration Product or Collaboration Service, which
termination shall not be a breach of this Agreement, in which case AMBION shall
provide ROSETTA with prompt written notice of same. Should AMBION fail to obtain
such rights within twelve (12) months after having received notice from ROSETTA
of such patent(s) and/or patent application(s), ROSETTA shall have the right
but
not the obligation, at its cost and expense, to negotiate and enter into a
license agreement or other arrangement to obtain such rights under such Third
Party patent(s) and/or patent application(s).
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.
26
(b) Third
Party Action.
If any
Third Party action, suit or proceeding is commenced against either Party
alleging any such AMBION Infringement, (i) AMBION shall have the obligation
to
defend such action, suit or proceeding at its sole expense; (ii) ROSETTA shall
have the right to separate counsel at its own expense in any such action, suit
or proceeding; and (iii) the Parties shall cooperate with each other in all
reasonable respects in any such action, suit or proceeding. Each Parry shall
provide the other Party with prompt written notice of the commencement of any
such suit, action or proceeding of which such Party becomes aware, and shall
promptly furnish the other Party with a copy of each communication relating
to
the alleged AMBION Infringement that is received by such Party. For purposes
of
clarity, nothing in this Section 7.2.2 shall affect the right of ROSETTA to
defend itself in any such action, suit or proceeding. However, AMBION shall
have
the sole authority to compromise, litigate, settle or otherwise dispose of
any
such suit, action or proceeding without ROSETTA’s prior written consent, if and
only if the disposition of such suit, action or proceeding (i) does not subject
ROSETTA to any financial obligation or duty whatsoever and (ii) does not require
or imply any acknowledgement of fault on the part of ROSETTA. Any other
disposition of such suit shall require ROSETTA’S prior written consent, which
shall not be unreasonably withheld, conditioned or delayed.
8. TERM
AND TERMINATION
8.1 Term.
This
Agreement shall commence on the Effective Date and shall continue in full force
and effect until (a) such time as AMBION is no longer Developing any
Collaboration Products or Collaboration Services for use in the Field or (b)
if,
as of the time AMBION is no longer Developing any Collaboration Products or
Collaboration Services for use in the field it is Commercializing one or more
Collaboration Products or Collaboration Services, such time as the Royalty
Term
for all such Collaboration Products or Collaboration Services has ended, unless
earlier terminated in accordance with the provisions of this Article 8 (the
“Term”).
8.2 Termination.
This
Agreement may be terminated at any time by either Party, or by the Party
specified, as follows:
8.2.1 Termination
for Breach. Either Party may terminate this Agreement, effective immediately
upon written notice to the other Party by giving sixty (60) days’ written notice
to the Party committing any material breach of this Agreement (or, to the extent
the material breach involves the failure to pay any amounts due under this
Agreement upon thirty (3o) days’ written notice). Notwithstanding anything to
the contrary set forth herein, (a) if the asserted breach is cured or shown
to
be non-existent within the sixty (60) or thirty (30) day cure period, the notice
of breach hereunder shall be deemed automatically withdrawn and (b) a material
default by a Party shall not give rise to the termination right under this
Section 8.2,1 to the extent such material default arises from a Force Majeure
event described in Section 12.10; provided, that the Party allegedly breaching
the Agreement shall have the burden of demonstrating the occurrence of the
Force
Majeure event.
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.
27
8.2.2 Termination
for Insolvency.
In the
event that either Party files for protection under the bankruptcy laws, makes
an
assignment for the benefit of creditors, appoints or suffers appointment of
a
receiver or trustee over its property, file a petition under any bankruptcy
or
insolvency act or has any such petition filed against it which is not discharged
within sixty (60) days of the filing thereof, then the other Party may terminate
this Agreement effective immediately upon written notice to such Party. In
connection therewith, all rights and licenses granted under this Agreement
are,
and shall be deemed to be, for purposes of Section 365(n) of the United states
Bankruptcy Code, licenses of rights to “intellectual property” as defined under
Section 101(56) of the United States Bankruptcy Code.
8.3 Consequences
of Termination of Agreement.
In the
event of the termination of this Agreement pursuant to Section 8.2 the following
provisions shall apply, as applicable.
8.3.1 Termination
by ROSETTA Pursuant to Section 8.2.1.
If this
Agreement is terminated by ROSETTA pursuant to Section 8.2.1, the following,
provisions shall apply:
(a) the
licenses and rights granted to AMBION pursuant to Section 5.1 shall immediately
terminate, and AMBION shall be deemed to have granted to ROSETTA, as of the
date
of termination, an exclusive (even as to AMBION), worldwide, royalty bearing
license, with the rights to sublicense, under AMBION Technology and AMBION
Patent Rights and AMBI.ON’S interest in Joint Program Technology and Joint
Program Patent Rights, to Develop, have Developed, Commercialize and have
Commercialized Collaboration Products and Collaboration Services then being
Developed or Commercialized for use in the Field; provided, that if XXXXXXX
xxxxx any such Collaboration Product or Collaboration Service itself, ROSETTA
shall pay royalties to AMBION as set forth in Section 3.1, mutatis
mutandis,
and if
ROSETTA licenses a Third Party to sell any such Collaboration Product or
Collaboration Service, ROSETTA shall pay to AMBION [***] percent ([***]%) of
all
royalties received from such Third Party with respect to sales of such
Collaboration Product or Collaboration Service.
(b) each
Party shall promptly return all Confidential Information and Proprietary
Materials of the Other Party that are not subject to a continuing license
hereunder; provided that each Party may retain one copy of the Confidential
Information of the other Party in its archives solely for the purpose of
establishing the contents thereof and ensuring compliance with its obligations
hereunder;
(c) upon-request
of ROSETTA, AMBION shall promptly, and in any event within sixty (60) days
after
ROSETTA’s request: (i) transfer to ROSETTA all of its right, title and interest
in all Regulatory Filings and Regulatory Approvals then in its name applicable
to any Collaboration Product or Collaboration Service, and all material aspects
of Confidential Information Controlled by it as of the date of termination
relating to such Regulatory Filings and Regulatory Approvals; (ii) notify the
applicable Regulatory Authorities and take any other action reasonably necessary
to effect such transfer, and (iii) provide ROSETTA with copies all
correspondence between. AMBION and such Regulatory Authorities relating to
such
Regulatory Filings and Regulatory Approvals; (iv) AMBION hereby grants to
ROSETTA an irrevocable power of attorney, coupled with an interest, to take
the
actions set forth in this Section 8.3.1 (c) if AMBION does not no so within
sixty (60) days of ROSETTA’s request.; 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.
28
(d) if
AMBION
has manufactured, is manufacturing or having manufactured any Collaboration
Product as of the effective date of termination: (i) AMBION shall, if requested
by ROSETTA, supply ROSETTA with its requirements for all such-Collaboration
Product for up to thirty-six (36) months following such termination at a
transfer price equal to AMBION’s fully burdened cast for the supply of such
Collaboration Product, and (ii) within sixty days after ROSETTA’s request,
AMBION shall provide to ROSETTA or its designee all information in its
possession with respect to the manufacture of each such Collaboration
Product.
8.3.2 Termination
by AMBION Pursuant to Section 8.2.1 or Section 8.2.2.
If this
Agreement is terminated by AMBION pursuant to Section 8.2.1 or Section
8.2.2:
(a) AMBION
shall continue to have the license and rights set forth in Section 5.1 to
Develop Collaboration Products and Collaboration Services being Developed by
AMBION as of the effective date of termination, if any, and to Commercialize
and
have Commercialized Collaboration Products and Collaboration Services being
Commercialized by AMBION as of the effective date of termination, if any,
subject to its continued payment of all royalty payments with reaped thereto;
and
(b) each
Party shall promptly return all Confidential Information and Proprietary
Materials of the other Party that are not subject to a continuing license
hereunder; provided that each Party may retain one copy of the Confidential
Information of the ether Party in its archives solely for the purpose of
establishing the contents thereof and ensuring compliance with its obligations
hereunder.
8.3.3 Termination
by ROSETTA Pursuant to Section 8.2.2.
If this
Agreement is terminated by ROSETTA pursuant to Section 8.2.2; to the extent
not
prohibited by Applicable Laws:
(a) the
license and rights set forth Section 5.1 shall survive solely as applied to
Collaboration Products and Collaboration Services being Commercialized by AMBION
as of the effective date of termination, if any, subject to AMBION’s continued
payment of all royalty payments under and in accordance with this Agreement
with
respect thereto; and
(b) each
Party shall promptly return all Confidential Information and Proprietary
Materials of the other Party that are not subject to a continuing license
hereunder; provided that each Party may retain one copy of the Confidential
Information of the other Party in its archives solely for the purpose of
establishing the contents thereof and ensuring compliance with its obligations
hereunder.
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.
29
8.4 Surviving
Provisions.
Termination or expiration of this Agreement for any reason shall be without
prejudice to:
(a) the
rights and obligations of the Parties provided in Sections 8.3 and 8.4 and
Articles 4, 6, 7, 10, 11, and 12 (including all other Sections or Articles
referenced in any such Section or Article and including Article 1) all of which
shall survive such termination;
(b) ROSETTA’s
rights to receive royalties for the duration of any applicable Royalty Term;
and
(c) any
either rights or remedies provided at law or equity which either party may
otherwise have.
9. REPRESENTATIONS
AND WARRANTIES
9.1 Mutual
Representations and Warranties.
ROSETTA
and AMBION each represents and warrants to the other, as of the Effective Date,
as follows:
9.1.1 Organization.
It is a
corporation duly organized, validly existing and in good standing under the
laws
of the jurisdiction of its organization, and has all requisite power and
authority, corporate or otherwise, to execute, deliver and perform this
Agreement.
9.1.2 Authorization.
The
execution and delivery of this Agreement and the performance by it of the
transactions contemplated hereby have been duly authorized by all necessary
corporate action and will not violate (a) such Party’s certificate of
incorporation or bylaws, (b) any agreement, instrument or contractual obligation
to which such Party is bound in any material respect, (c) any requirement of
any
Applicable Law, or (d) any order, writ, judgment, injunction, decree,
determination or award of any court or governmental agency presently in effect
applicable to such Party.
9.1.3 Binding
Agreement.
This
Agreement is a legal, valid and binding obligation of such Party enforceable
against it in accordance with its terms and conditions.
9.1.4 No
Inconsistent Obligation.
It is
not under any obligation, contractual or otherwise, to any Person that conflicts
with or is inconsistent in any respect with the terms of this Agreement or
that
would impede the diligent and complete fulfillment of its obligations
hereunder.
9.2 Additional
Representations of ROSETTA.
ROSETTA
further represents and warrants to AMBION, as of the Effective Date, as
follows:
9.2.1 Right
to Technology.
ROSETTA
has the right to (a) use the Licensed Technology and Licensed Patent Rights
existing as of the Effective Date as is necessary to fulfill its obligations
under this Agreement; and (b) grant the licenses under the Licensed Patent
Rights existing as of the Effective Date granted pursuant to 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.
30
9.2.2 No
Conflict.
The
grant to AMBION of the license to the Licensed Patent Rights existing as of
the
Effective Date contemplated by this Agreement will not conflict with any
agreement to which ROSETTA is a party as of the Effective Date.
10. IDEMNIFICATION
10.1 Idemnification
of AMBION by ROSETTA.
ROSETTA
shall indemnify, defend and hold harmless AMBION, its Affiliates, their
respective directors, officers, employees and agents, and their respective
successors, heirs and assigns (the “AMBION Indemnitees”), against all
liabilities, damages, losses and expenses (including reasonable attorneys’ fees
and expenses of litigation), (collectively, “Losses”) incurred by or imposed
upon the AMBION Indemnitees, or any one of them as a direct result of any
claims, suits, actions, demands or judgments of Third Parties; including without
limitation; personal injury and product liability matters and claims of
suppliers and employees (collectively, “Claims”) arising out of any action by
ROSETTA in the conduct of the Development Program; provided that, with respect
to any Claim for which ROSETTA has an obligation to any AMBION Indemnitee
pursuant to this Section 10.1 and AMBION has an obligation to any ROSETTA
Indemnitee pursuant to Section 10.2, each Party shall indemnify each of the
other Party’s indemnitees for its Losses to the extent of its responsibility for
the facts underlying the Claim relative to the other Party.
10.2 Indemnification
of ROSETTA by AMBION.
AMBION
shall indemnify, defend and hold harmless ROSETTA, its Affiliates, their
respective directors, officers, employees and agents and their respective
successors, heirs and assigns (the “ROSETTA Indemnitees”), against any Losses
incurred by or imposed upon the ROSETTA Indemnitees or any one of them, as
a
direct result of any Claims arising out of (a) any action AMBION in the conduct
of the Development Program, (b) the Development by AMBION of any Collaboration
Product or Collaboration Service, (c) the Commercialization (including, without
limitation, the production, manufacture, promotion, import, sale or use by
any
Person) of any Collaboration Product or Collaboration Service that is
manufactured or sold by AMBION or by an Affiliate, Sublicensee, Distributor
or
agent of AMBION; provided that with respect to any Claim for which ROSETTA
has
an obligation to any AMBION Indemnitee pursuant to Section 10,1 and AMBION
has
an obligation to any ROSETTA Indemnitee pursuant to this Section 10.2, each
Party shall indemnify each of the other Party’s Indemnifities for its Losses to
the extent of its responsibility for the facts underlying the Claim relative
to
the other Party.
10.3 Conditions
to Indemnification.
Person
seeking recovery under this Article 10 (the “Indemnified Party”) in respect of a
Claim shall give prompt notice of such Claim to the Party from which-recovery
is
sought (the “Indemnifying Party”) and, provided that the Indemnifying Party is
not contesting its obligation under this Article 1.0, shall permit the
Indemnifying Party to control any litigation relating to such Claim and the
disposition of such claim; provided that the Indemnifying Party shall act
reasonably and in good faith with respect to all matters relating to the
settlement or disposition of such Claim as the settlement or disposition relates
to Parties being indemnified under, this Article 10. The Indemnifying Party
may
settle or otherwise resolve such claim without the prior written consent of
the
Indemnified Party if and only if the resolution of such claim (i) does not
subject the Indemnified Party to any obligation or duty whatsoever and (ii)
does
not require or imply any acknowledgement of fault on the part of the Indemnified
Party. The Indemnified Party shall cooperate with the Indemnifying Party in
its
defense of any such Claim in all reasonable respects and shall have the right
to
be present in person or through counsel at all legal proceedings with respect
to
such Claim. Any other disposition of such suit shall require ROSETTA’S prior
written consent, which shall not be unreasonably withheld, conditioned or
delayed,
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.
31
10.4 Warrant
Disclaimer.
EXCEPT
AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY
WARRANTY WITH RESPECT TO ANY TECHNOLOGY, GOODS, SERVICES, RIGHTS OR OTHER
SUBJECT MATTER OF THIS AGREEMENT AND EACH PARTY HEREBY DISCLAIMS ALL WARRANTIES,
EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT:
10.5 No
Warranty of Success.
Nothing
contained in this Agreement shall be construed as a warranty on the part of
either Party that (a) the Development Program will yield any Collaboration
Product or Collaboration Service or otherwise be successful or (b) the outcome
of the Development Program will be commercially exploitable in any
respect.
10.6 Limited
Liability.
NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, NEITHER PARTY SHALL
BE LIABLE TO THE OTHER PARTY OR ANY OF ITS AFFILIATES FOR (I) ANY SPECIAL,
PUNITIVE, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, MCLUDING WITHOUT
LIMITATION LOST PROFITS OR LOST REVENUES, OR (II) COST OF PROCUREMENT OF
SUBSTITUTE GOODS, TECHNOLOGY OR SERVICES, WHETHER UNDER ANY CONTRACT, WARRANTY,
NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY.
10.7 Insurance.
Not
later than nine (9) months after the Effective Date, but in any event prior
to
use or testing of any product on humans, and at all times thereafter until
the
expiration of all applicable statutes of limitation pertaining to any
manufacture, marketing, possession, use, sale of other disposition of any
Collaboration Products or Collaboration Services, AMBION will, at its expense,
obtain and maintain in full force and effect, comprehensive general liability
insurance, including product liability insurance; against all claims,
obligations, liabilities, and damages, based upon or arising out of actual
or
alleged bodily injury, personal injury, death, or any other damage to or loss
of
persons or property, caused by any such manufacture, marketing, possession,
use,
sale, or other disposition. Each such policy shall name ROSETTA as an additional
insured party:
11. DISPUTE
RESOLUTION
11.1 Dispute
Resolution.
In the
event of any dispute arising between the Parties in connection with this
Agreement, the construction thereof, or the rights, duties or liabilities of
either Party (each a “Disputed Matter”), the Disputed Matter shall be submitted
to the Designated Senior Officers of the Parties for good faith resolution.
In
the event the Disputed Matter cannot be resolved by the good faith efforts
of
the Designated Senior Officers on or before thirty (30) days from the date
such
Disputed Matter is first presented for resolution, then such Disputed Matter
shall be resolved by binding arbitration in accordance with the following
procedures.
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.
32
(a) The
arbitration shall be conducted by a panel of three (3) persons experienced
in
the pharmaceutical business who are independent of both Parties. Within thirty
(30) days after initiation of arbitration, each Party shall select one person
to
act as arbitrator and the two Party-selected arbitrators shall select a third
arbitrator within thirty (30) days of their appointment. If the arbitrators
selected by the Parties are unable or fail to agree upon the third arbitrator,
the-third arbitrator shall he appointed by the American Arbitration Association
(“AAA” ). The place of arbitration shall be New York, New York, and all
proceedings and communications shall be in English. Except as provided for
differently herein, the arbitration shall be conducted under the rules of the
AAA applicable to complex business disputes.
(b) Either
Party may apply to the arbitrators for interim injunctive relief until the
arbitration decision is rendered or the Disputed Matter is otherwise resolved.
Either Party also may, without waiving any right or remedy under this Agreement,
seek from any court having jurisdiction any injunctive or provisional relief
necessary to protect the rights or property of that Party pending resolution
of
the Disputed matter pursuant to this Section 11.1. The arbitrators hall have
no
authority to award punitive or any other type of damages not measured by a
Party’s compensatory damages. Each Party shall bear its own costs and expenses
and attorneys’ fees, and the Party that does not prevail in the arbitration
proceeding shall pay the arbitrators’ fees and, any administrative fees of
arbitration.
(c) Except
to
the extent necessary to confirm an award or decision as may be required by
Applicable Laws, neither a Party nor an arbitrator may disclose the existence,
content, or results of an arbitration without the prior written consent of
both
Parties. In no event shall an arbitration be initiated after the date when
commencement of a legal or equitable proceeding based on the Disputed Matter
would be barred by the applicable New York statute of limitations.
(d) The
Parties agree that, in the event an Arbitration Matter involving the alleged
breach of this Agreement (including, without limitation, whether a Party has
satisfied its diligence obligations hereunder), neither Party may terminate
this
Agreement until resolution of the Disputed Matter pursuant to this Section
11.1.
(e) The
Parties hereby agree that any disputed performance or suspended performance
pending the resolution of an Disputed Matter that the arbitrators determine
to
be required to be performed by a Party must be completed within a reasonable
time period following the final decision of the arbitrators.
(f) The
Parties hereby agree that any monetary payment to be made by a Party pursuant
to
a decision of the arbitrators shall be made in United States dollars, free
of
any tax or other deduction. The Parties further agree that the decision of
the
arbitrators shall be the sole, exclusive and binding remedy between thorn
regarding determination of Disputed Matters presented.
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.
33
12. MISCELLANEOUS
12.1 Notices.
All
notices and communications shall be in writing and delivered personally or
by
courier providing evidence of delivery or mailed via certified mail, return
receipt requested, addressed as follows, or to such other address as may be
designated from time to time:
If
to
AMBION:
0000
Xxxxxxxx Xx.
Xxxxxx,
Xxxxx 00000
Telephone
Number:(000) 000 0000
Facsimile
Number: (000) 000 0000
Attention:
Vice-President of Business Development
cc:
General Counsel
if
to
ROSETTA;
Rosetta
Genomics, Ltd.
00
Xxxxx
Xxxxxx
Xxxxxxx
Xxxx
Xxxxxxx,
Xxxxxx
Tel:
000-0-000-0000
Fax:
000-0-000-0000
Attention:
Managing Director
With
a
copy to:
Mintz,
Levin, Cohn, Ferris, Glovsky
and
Popeo, PC
Xxx
Xxxxxxxxx Xxxxxx
Xxxxxx,
Xxxxxxxxxxxxx 00000
Attention:
Xxxxxxx Xxxxxx
Tel:
(000) 000-0000
Fax:
(000) 000-0000
Except
as
otherwise expressly provided in this Agreement or mutually agreed in writing,
any notice, communication or document (excluding payment) required to be given
or made shall be deemed given or made and effective upon actual receipt or,
if
earlier, (a) three (3) business days after deposit with an
internationally-recognized overnight express courier with changes prepaid,
or
(b) five (5) business days after mailed by certified, registered or regular
mail, postage prepaid, in each case addressed to a Parties at its address stated
above or, to such other address as such Party may designate by written notice
in
accordance with this Section 12.1.
12.2 Governing
Law.
This
Agreement shall be governed by and construed in accordance with the laws of
the
State of Now York (USA), without regard to the application of principles of
conflicts of law.
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.
34
12.3 Binding
Effect.
This
Agreement shall be binding upon and inure to the benefit of the Parties and
their respective legal representatives, successors and permitted
assigns.
12.4 Headings.
Section
and subsection headings are inserted for convenience of reference only and
do
not form a part of this Agreement.
12.5 Counterparts.
This
Agreement may be executed simultaneously in two or more counterparts, each
of
which shall be deemed an original and both of which, together, shall constitute
a single agreement.
12.6 Amendment;
Waiver.
This
Agreement may be amended, modified, superseded or canceled, and any of the
terms
of this Agreement maybe waived, only by a written instrument executed by each
Party or, in the case of waiver, by the Party or Parties waiving compliance.
The
delay or failure of any Party at any time or times to require performance of
any
provisions shall in no manner affect the rights at a later time to enforce
the
same. No waiver by any Party of any condition or of the breach of any term
contained in this Agreement, whether by conduct, or otherwise, in any one or
more instances, shall be deemed to be, or considered as, a further or continuing
waiver of any such condition or of the breach of such term or any other term
of
this Agreement.
12.7 No
Third Party Beneficiaries.
Except
as set forth in Sections 10.1 and 10.2, no Third Party (including, without
limitation, employees of either Party) shall have or acquire any rights by
reason of this Agreement.
12.8 Purposes
and Scope.
The
Parties hereto understand and agree that this Collaboration is limited to the
activities, rights and obligations as set forth in this Agreement. Nothing
in
this Agreement shall be construed (a) to create or imply a general partnership
between the Parties, (b) to make either Party the agent of the other for any
purpose, (c) to alter, amend; supersede or vitiate any other arrangements
between the Parties with respect to any subject matters not covered hereunder,
(d) to give either Party the right to bind the other except as expressly set
forth herein, (e) to create any duties or obligations between the Parties except
as expressly set forth herein, or (f) to grant any director implied licenses
or
an other right other than as expressly set forth herein.
12.9 Assignment
and Successors.
Neither
this Agreement nor any obligation of a Party hereunder maybe assigned by either
Party without the consent of the other Party, except that each Party may assign
this Agreement and the rights, obligations and interests of such Party, in
whole
or in part, to any of its Affiliates, to any purchaser of all of its capital
stock or assets and/or all of its assets to which this Agreement relates or
to
any successor corporation resulting from any merger or consolidation of such
Party with or into such corporation.
12.10 Force
Majeure.
Neither
AMBION nor ROSETTA shall be liable for failure of or delay in performing
obligations set forth in this Agreement, and neither shall be deemed in breach
of its obligations, if such failure or delay is due to a Force Majeure. In
event
of such Force Majeure event, the Party affected thereby shall use reasonable
efforts to cure or overcome the same and resume performance of its obligations
hereunder.
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.
35
12.11 Interpretation.
The
Parties hereto acknowledge and agree that: (a) each Party and its counsel
reviewed and negotiated the terms and provisions of this Agreement and have
contributed to its revision; (b) the rule of construction to the effect that
any
ambiguities are resolved against the drafting Party shall not be employed in
the
interpretation of this Agreement; and (c) the terms and provisions of this
Agreement shall be construed fairly as to all Parties hereto and not in favor
of
or against any Party, regardless of which Party was generally responsible for
the preparation of this Agreement.
12.12 Integration;
Severability.
This
Agreement and the Existing Agreements are the entire agreement with respect
to
the subject matter hereof and supersedes all other agreements and understandings
between the Parties with respect to such subject matter. If any provision of
this Agreement is or becomes invalid or is ruled invalid by any court of
competent jurisdiction or is deemed unenforceable, it is the intention of the
Parties that the remainder of the Agreement shall not be affected.
12.13 Further
Assurances.
Each of
ROSETTA and AMBION agrees to duly execute and deliver, or cause to be duly
executed and delivered, such further instruments and do and cause to be done
such further acts and things, including, without limitation, the filing of
such
additional assignments, agreements, documents and instruments, as the other
Party may at any time and from time to time reasonably request in connection
with this Agreement or to carry out more effectively the provisions and purposes
of or to better assure and confer unto such other Party its rights and remedies
under this Agreement.
THE
REST
OF THIS PAGE WAS INTENTIONALLY LEFT BLANK.
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.
36
IN
WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their
duly authorized representatives.
ROSETTA
GENOMICS, LTD.
By:_______________________________
Name:
Xxxx Xxxxxx
Title:
President and COO
AMBION
DIAGNOSTICS, INC.
By:_______________________________
Name:
Xxxx Xxxxxxx
Title:
CEO
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.
37
EXHIBIT
A
DEVELOPMENT
PLAN
Discovery
Stage: [***]
Rosetta
and Ambion will [***] in the [***] of [***] and [***] to [***]Rosetta and Ambion
will [***] the [***] of [***] that can be [***] that can be [***] to this and
[***]
[***]
Rosetta
and Ambion will [***]this could be [***] if the [***] after the [***] associated
with the [***]. At this [***] from the two companies will [***] to the [***]
below to [***] of the [***]each party shall[***] during the [***] after this
[***] during the [***] after this [***]given limitations of the
[***]
Clinical
Development Stage:
[***]
Phase
1: [***]
(1)
|
[***]will
be [***] upon during the [***] that represent the best opportunity
for
[***]
|
(2) |
[***]
from [***]
|
(5)
|
[***]
upon at the [***]
|
(4)
|
[***]within
the [***]
|
(5) |
[***] [***]
then proceed with [***]
|
Goals. |
[***]
that can be [***]
|
Phase
2: [***]
(l)
|
[***]
to measure; [***] associated with each of
the[***]
|
(2) |
[***]
with known [***]
|
(3)
|
[***]
The number of [***] will be decided
[***]
|
(4) |
[***]
from [***]
|
(5)
|
[***]
from the [***] If the [***] appropriate [***] then proceed with the
[***]
with [***] to establish [***]
|
Goals:
[***]
of
the [***]Use these [***] of the [***]
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.
A-1
Phase
3: [***]
(1) |
[***]
|
(2) |
[***]
with [***]
|
(3) |
[***]
some or all [***] [***]
|
(4)
|
[***]
appropriate [***] then [***] with [***] with
[***]
|
Goal:
[***] that can be [***] for the [***]
Phase
4: [***]
(1)
|
[***]
with the [***] for the[***]
|
(2)
|
[***]
that can [***] of the [***]
|
(3) |
[***]
into their [***]
|
(4)
|
[***]
of the [***]
|
(5) |
[***]
as an [***]
|
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.
A-2
SCHEDULE
1
THIS
SCHEDULE WAS INTENTIONALLY LEFT BLANK
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.
Sched.
SCHEDULE
2
LICENSED
PATENT RIGHTS
App
No
|
Filed
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[***]
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[***]
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[***]
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||
[***]
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[***]
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[***]
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[***]
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||
[***]
|
[***]
|
[***]
|
[***]
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||
[***]
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[***]
|
[***]
|
[***]
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||
[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
|
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.
Sched.
2
SCHEDULE
3
COLLABORATION
PRODUCTS
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.
Sched.
3
SCHEDULE
4
ROSETTA
MARKETING DEVELOPMENT ACTIVITIES
1. |
ROSETTA
will use [***] during the [***] from the
[***]
|
a.
[***]
of
at [***]
b. [***]
of
at [***] in at [***]
c. [***],
and
d. [***]
2.
|
Provision
by ROSETTA of [***] established by ROSETTA [***] until such time
as [***]
or other [***] for [***] by AMBION.
|
3. |
[***]
with AMBION [***]
|
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.
Sched.
4
SCHEDULE
5
RESTRICTIONS
ON USE
NOTICE
TO
PURCHASE: LIMITED LICENSE:
This
product is sold under licensing arrangement between Ambion Diagnostics, Inc.
and
Rosetta Genomics, Ltd. The purchase price of this product includes limited,
nontransferable rights under patents and/or pending patent applications owned
by
Rosetta Genomics to use the product for commercial purposes solely for (a)
the
determination of (i) the presence of Prostate cancer, (ii) the state,
progression or severity of Prostate Cancer, or (iii) the effect on Prostate
Cancer of a particular treatment; and/or (b) the selection of patients for
a
particular treatment with respect to applications may be obtained by contacting
Rosetta Genomics, Director of Business Development XX@Xxxxxxxxxxxxxxx.xxx
(Phone
number to be added.)
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.
Sched.
5