LICENSE AGREEMENT
This
License Agreement (the "Agreement")
is
dated
as of the 23rd day of November, 2004 (the "Effective
Date"), by
and
between Response Genetics, Inc., located
at 0000 Xxxxxxx Xx., Xxx Xxxxxxx, Xxxxxxxxxx 00000 ("RGI") and Roche
Molecular
Systems, Inc., located at 0000 Xxxxxxxx Xxxxx, Xxxxxxxxxx, Xxxxxxxxxx 00000
("RMS").
WHEREAS
RGI owns certain RGI Patent Rights (identified in Exhibit "1") and has
the
right
to grant licenses thereunder; and
WHEREAS
RMS owns certain patent rights, has developed certain technology, and
possesses expertise relating to the preparation of assays;
WHEREAS
RGI has entered into and will continue to enter into collaborations with
pharmaceutical companies in connection with the development by RGI of research
assays
(each an "RGI Assay");
WHEREAS
RMS and RGI wish to collaborate so that RMS will obtain access to the
RGI
Patent Rights and the RGI Assays so that RMS may develop, optimize, manufacture
and sell assays for research, investigational and in vitro diagnostic use (
"Optimized
Assays"); and
WHEREAS
RMS wishes and intends to manufacture and sell the Optimized Assays
developed hereunder in the Licensed Territories (as defined
hereinafter),
IT
IS
THEREFORE AGREED:
1.
GENERAL
DEFINITIONS
1.1 Affiliate.
The
term
"Affiliate" shall mean, with respect to any Person,
any other Person that, directly or indirectly, controls, is controlled by or
is
under common control with, that Person, provided however, that in each case
any
such other Person
shall be considered to be an Affiliate only during the time during which such
control exists. For purposes of this definition, "control" (including, with
correlative meaning,
the terms "controlled by" and "under common control with"), as used with respect
to any Person, shall mean the possession, directly or indirectly, of the power
to direct
and/or cause the direction of the management and policies of such Person,
whether through the ownership of voting securities, by contract or otherwise.
With regard
to
RMS, the term Affiliate shall not include Genentech, Inc., 0 XXX Xxx, Xxxxx
Xxx
Xxxxxxxxx, Xxxxxxxxxx 00000-0000, U.S.A. ("Genentech") or Chugai Pharmaceutical
Co.,
Ltd,
0-0, Xxxxxxxx 0-xxxxx, Xxxx-xx, Xxxxx, 000-0000, Xxxxx ("Chugai").
1.2 Claim.The
term
"Claim" shall mean a claim of an issued patent which
has
not expired and which has not been disclaimed, canceled or held invalid or
unenforceable
by a court of competent jurisdiction.
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.
1.3 End
Product.
The
term
"End Product" shall mean any Optimized Assay
sold for in vitro diagnostic use that is covered in whole or in part by a Claim
included
within the RGI Patent Rights.
1.4 Field.
The
term
"Field" shall mean the research, development, manufacture
and sale of assays by RMS, including but not limited to the Optimized
Assays.
1.5 Licensed
Territories.
The
phrase "Licensed Territories" shall mean
the
United States and all foreign countries or regions worldwide.
1.6 Net
Sales.
The
phrase Net Sales shall mean the amounts invoiced for End Products by members
of
the RMS Group to purchasers and other transferees after deduction of volume
discounts, sales rebates, reimbursements for returns, and sales taxes (e.g.,
value added taxes) and other taxes directly linked to the sales (provided that
such taxes are invoiced to and paid by such purchasers or other transferees),
but excluding discounts, rebates, price reductions and/or credits to customers
on account of settlement of complaints, less the following deductions for.
a)
"Sales
Expenses" in the amount of [***] percent ([***]%), provided that this
percentage shall be reduced in accordance with each general reduction by RMS
of
such
Sales Expenses in connection with the calculation of royalties payable with
respect to
the
sale of diagnostic kits; b) "Reagent Rental Deduction" in the amount of
[***]
percent ([***]%), provided that this percentage shall be reduced in accordance
with
each
general reduction by RMS of such Reagent Rental Deductions in connection with
the calculation of royalties payable with respect to the sale of diagnostic
kits; and c) deductions for "Third Party Royalty Expenses".
Net
Sales
shall be determined from the books and records of RMS and its Affiliates.
In the event that an End Product is sold together with one or more other
product(s)
at a single price (a "Combination Product"), such single price shall be
allocated
among the End Product(s) and the other product(s) in the Combination
Product
based upon the relevant market prices for such products when sold separately.
If
any such product is not sold separately, RGI and RMS shall in good faith discuss
and agree upon a fair market price for that product and that price shall be
used
to calculate the
Net
Sales.
When
End
Products are not sold, or are not sold and itemized separately, but are
otherwise transferred or sold together with one or more other products as part
of a
sales
transaction, the Net Sales of such End Products shall be calculated according
to
their
sale prices when sold separately, or, if there are no such prices, then
according to the average of prices at which products of the most similar kind
and quality, sold in similar
quantities, are then being offered for sale by RMS and/or its Affiliates. If
a
selling price
cannot thus be determined, then it shall be the fair market value of the End
Product in question.
"Sales
Expenses" shall mean a lump sum deduction in lieu of deductions for actual
internal expenses of RMS or its Affiliates such as for (a) tariffs, duties
and
taxes imposed
upon the production, sale, delivery or use of End Products (excluding taxes
that
are separately invoiced to end users, distributors or agents); (b) distribution
and other customary expenses,
such as freight, transportation and insurance expenses, and (c) cash discounts,
retroactive price reductions or credits to customers on account of settlement
of
complaints.
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
"Reagent
rental expenses" shall mean a lump sum deduction of fees for all services which
are included in reagent prices such as instrument service costs, instrument
depreciation,
finance costs, disposables and rental fees.
"Third
Party Royalty Expenses" shall mean royalties paid to Third Persons by
RMS
and/or its Affiliates to obtain rights and licenses under Blocking Third Party
Intellectual
Property, excluding any royalties paid to Third Persons that can be allocated
to
rights
and licenses not directly necessary for RMS and its Affiliates to make, have
made, use, import, offer to sell or sell End Products.
"Blocking
Third Party Intellectual Property" shall mean, with respect to any country
in
the Licensed Territories, patent rights in such country, owned or controlled
by
a Third Person, that cover specific reagents, assays, processes and/or platforms
or any other technology required for the use, importation, manufacture, offer
for sale or sale of an
End
Product, if the manufacture, use, importation, offer for sale or sale of such
End Product would in the absence of a license granted by such Third Person,
infringe such patent
rights.
1.7 RGI
Patent Rights.
The
phrase "RGI Patents Rights" shall mean and
include (i) all United States and foreign applications for patents listed in
Exhibit
"1".
as
well
as all United States and foreign patents that have or may hereafter issue in
respect of such applications for patents, and (ii) all applications for patents
whose subject matter in whole or in part is entitled to the benefit of the
filing date(s) of any of the
applications for patents listed on Exhibit "1" and all United States and foreign
patents that have or may hereafter issue in respect of such applications for
patents, including
in each case of the foregoing clauses (i) and (ii) of this Section 1.7, without
limitation,
all continuations, continuations-in-part, divisionals, substitutions, Patent
Cooperation
Treaty applications, United States provisional patent applications, continued
prosecution applications, utility models, supplementary protection certificates,
reexaminations,
renewals, extensions and reissues thereof.
1.8 Person.
The
term
"Person" shall mean an individual or any legally recognized entity, including
any corporation, partnership, limited partnership, limited liability company,
association or trust.
1.9 RGI
Technical Information.
The
phrase "RGI Technical Information"
shall mean RGI unpatented intellectual property, including
know-how.
1.10 RMS
Group.
The
phrase "RMS Group" shall mean RMS and its Affiliates.
1.11 RMS
Technical Information.
The
phrase "RMS Technical Information"
shall mean RMS unpatented intellectual property, including
know-how.
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
1.12
Third
Person.
The
phrase "Third Person" shall mean a Person other than RGI and members of the
RMS
Group.
2.
COLLABORATION
2.1 Description
of Cotlaboration.
Subject
to the other terms and conditions herein, RGI will collaborate exclusively
with
RMS in the area of commercial assay development related to the validation of
genetic markers for pharmaceutical companies
as follows. At such time as RGI validates a genetic marker for a pharmaceutical
company, with respect to such marker's ability to aid in the prediction of
a
patient's therapeutic response to a pharmaceutical compound, RGI will provide
RMS with the related RGI Assay, as well as relevant detailed information
regarding RGI's collaboration
with the said pharmaceutical company to the extent that that is authorized
by
the
said pharmaceutical company, for the purposes described in Section 2.2
below.
2.2 With
regard to the commercialization of the RGI Assays:
(1) For
those
RGI Assays that meet RMS's customary criteria for commercialization, RMS shall
make commercially reasonable efforts to enter into agreements with
pharmaceutical companies to optimize the RGI Assays so that they may
be
used as commercial diagnostic assays. Through its purchase of the reagents
as
described in Section 2.7, RGI is hereby granted the right to use the Optimized
Assays for research only. RMS will own all improvements or modifications made
solely by RMS to the RGI Assays or RGI Patent Rights, including any such
improvements to the Optimized Assays, and RMS retains the sole discretion as
to
any use of the said improvements or modifications;
(2) RMS
may
sublicense or enter into contract manufacturing agreements with
third parties to optimize and commercialize the RGI Assays, provided that RMS
provides RGI with sixty (60) days written notice of such sublicense or contract
manufacturing agreement, and further provided that the sublicensee or contract
counter-party, as the case may be, agrees to all of the terms and conditions
hereof pertaining
to the protection of RGI Patent Rights and RGI Technical Information, including
the confidentiality, indemnity, etc. provisions. Furthermore, all other terms
and conditions
of this Agreement shall apply to and in the event of any such sublicense or
contract
arrangement; or
(3) In
the
event that RMS determines in good faith that an RGI Assay does not meet Roche's
customary criteria for commercialization and that it is therefore commercially
reasonable to make no effort to enter into an agreement with a pharmaceutical
company in accordance with Section 2.2(1), and RMS chooses not to sublicense
or
contract in accordance with Section 2.2(2), then RGI shall be free, either
alone
or
in collaboration with any counterparty of its choosing, to enter into agreements
with
pharmaceutical companies to improve, refine, and optimize the RGI Assay in
question so that it may be used by RGI as a commercial diagnostic assay as
part
of RGI's
diagnostic services, subject to any royalties, if any, payable under the terms
of RGI's
Diagnostic Service License Agreement effective November 16, 2004. RMS shall
have
no
further rights in the particular RGI Assay or in any improvements made by RGI
or
any
third 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.
4
2.3 Packaging
and Labeling.
RMS
will
design and develop all packaging,
labels, and instructional material for any Optimized Assay that RMS or its
Affiliates
commercialize.
2.4 Regulatory
Approvals.
RMS
shall
obtain any and all regulatory approvals
required in order to commercialize End Products.
2.5 Instrumentation.
RMS
shall
provide RGI with up to [***] thermal cycler
instruments ("RMS Instruments"), to be determined by RMS and RGI in good faith
consultation during the term of this collaboration, in order to assist RGI
in
utilizing Optimized
Assays. RGI may obtain support and training from RMS or its Affiliates on
such
instruments at fees, terms and conditions discounted [***]% off of list prices.
Title to the RMS Instruments shall at all times remain with RMS and at the
expiration or termination of this Agreement RGI shall return the RMS Instruments
as directed by RMS, provided, however, that RGI shall have the option to
purchase any and all of the RMS Instruments at the lesser of (a) their
respective depreciated values and (b) their respective
market prices.
2.6 Research
Support.
RMS
shall
provide research support to RGI in connection
with the transfer of the Optimized Assay to RGI in the form of training and
consulting
services by RMS full-time employees. Such full-time employee support shall
be
based upon requirements, which shall be determined by RMS and RGI in good faith
consultation,
with reasonable final determinations to be made by RMS.
2.7 Supply
of Reagents.
Research
use only reagents for the Optimized
Assay shall be provided by RMS to RGI at a cost to RGI of not more than $[***]
per assay. For these purposes, an "assay" shall mean measurement of relative
gene
expression (by qRT PCR) of three genes and one constitutively expressed control
gene
with
respect to a tissue specimen. The aforesaid price shall also cover all
reagents
for all required run controls with regard to the specimens
analyzed.
3.
GRANTS,
ETC
3.1 License
Grant to RMS.
Subject
to the terms and conditions of this Agreement, including Section 2.2, RGI hereby
grants to RMS Group under the RGI Patent
Rights an exclusive license in the Field in the Licensed Territories to make,
have made,
use, practice, import, offer to sell and sell End Products.
3.2 License
Grant to RGI. Subject
to the terms and conditions of this Agreement, RMS hereby grants to RGI a
license to the Optimized Assays. This grant to RGI
shall
be for its internal use in RGI's diagnostic service business and during the
term
of
the
collaboration shall be without royalty, but without any rights to sublicense
or
transfer
to any third party. After the termination of the collaboration, the Optimized
Assays
will be licensed to RGI for its internal diagnostic services for a royalty
of
[***] percent ([***]%) of [***] percent ([***]%) of Net Service Revenue as
that
term is defined in the
Expanded PCR Diagnostic Services Agreement by and between RMS and RGI,
effective
November 16, 2004, without right of sublicense or transfer to third parties.
For
the
avoidance of doubt, RGI shall not be granted the right to resell, transfer
or
otherwise provide
the Optimized Assays to any third party. Further, RGI is not granted any right
to make, have made, import, offer to sell or sell any Optimized
Assays.
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
3.3 Covenant
Not to Grant Further Licenses.
RGI
covenants and agrees
not to grant any additional licenses in the Field under the RGI Patent Rights
to
any Third Person without the prior written consent of RMS, which consent shall
not be unreasonably
withheld.
3.4 Patent
Prosecution and Maintenance, Etc. Each
party shall have
the
exclusive right to prosecute and maintain the United States and foreign
applications for patents and patents comprising its respective patent rights
using counsel of its choice at its expense. The costs and expenses of all
interferences will be considered
prosecution expenses. RGI shall make reasonable efforts to provide RMS
with
copies of relevant documentation so that RMS may be apprised of the continuing
prosecution of the RGI Patent Rights and any challenges by Third Persons to
the
validity
or enforceability of the RGI Patent Rights. With respect to documentation
relating
to prosecution of the RGI Patent Rights, RMS may comment upon such documentation
provided such comments are made sufficiently in advance of any deadline
for filing a response. All such documentation shall be treated as the
Proprietary
Information of RGI and shall be held in confidence in accordance with the
provisions of Article 5 herein. Should RGI decide not to make commercially
reasonable efforts to preserve the RGI Patent Rights, or not to seek patent
protection or to discontinue patent protection for the RGI Patent Rights, RGI
shall promptly notify RMS of
its
decision and grant RMS the right to prepare, file and prosecute or have
prepared, filed
or
prosecuted patents and patent applications directed to the RGI Patent
Rights.
3.5 Enforcement
Rights.
RGI
retains the right to assert and enforce against
any and all third parties suits for infringement of the RGI Patent Rights.
RMS
retains the right to assert and enforce against any and all third parties suits
for infringement of the RMS patent rights. If RGI declines to enforce its rights
in the RGI Patent Rights, then RMS may proceed to enforce those rights against
infringement. The party prosecuting any such infringement shall pay for the
costs of such proceedings, control the conduct of such proceedings, enforce
the
rights in question vigorously,
and recover any awards made in such proceedings. The non-enforcing party
agrees
to
cooperate reasonably in such proceedings, and the enforcing party will pay,
and
will hold the non-enforcing party harmless from, any costs and expenses incurred
by
the
non-enforcing party as a result of any such action.
3.6 Deliveries
of Files, Etc.
Within
thirty (30) days after the Effective Date,
RGI
shall make available to RMS copies of all required files, documents and records
of RGI regarding the RGI Patent Rights as of the Effective Date. RGI shall
also
provide
RMS with appropriate technical consulting services, as reasonably requested
by
RMS, to help RMS in its understanding, utilization and implementation of the
RGI
Patent Rights,
from time to time at no additional charge to RMS. RMS shall provide RGI with
appropriate
technical consulting services, as reasonably requested by RGI, to help RGI
in
its understanding, utilization and implementation of the Optimized Assays,
from
time to
time
at no additional charge to RGI.
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
4.
REPRESENTATIONS,
WARRANTIES AND INDEMNITIES
4.1 Representations
and Warranties of RMS.
RMS
hereby represents, warrants and covenants to RGI that:
(a) RMS
is a
corporation duly organized, validly existing and in good standing
under the laws of Delaware, with full power to carry on its business and
activities as now being conducted;
(b) This
Agreement has been duly authorized, executed and delivered by RMS and represents
its binding obligation, enforceable against it in accordance with its
terms
and conditions. RMS has the corporate power and authority to enter into this
Agreement
and to perform its obligations hereunder. No other act, approval or proceeding
on the part of RMS is or will be required to authorize the execution and
delivery of this Agreement, or the consummation of the transactions contemplated
hereby;
and
(c) The
execution and delivery by RMS of this Agreement will not, and the fulfillment
of
and compliance by RMS with the terms, conditions and provisions hereof
will not: (i) conflict with any of the terms, conditions or provisions of the
articles of incorporation
or by-laws of RMS or of any of its Affiliates, (ii) violate any term, condition
or provision of, or require any consent, authorization or approval under, any
judicial or arbitration
judgment, order, award, writ, injunction or decree applicable to RMS or any
of
its Affiliates, or (iii) conflict with, result in a breach of, constitute a
default under (whether with
or
without the giving of notice or the lapse of time or both), or accelerate or
permit the
acceleration of the performance required by, or require any consent,
authorization or approval under any document, instrument, agreement or license
to which RMS or any of its
Affiliates is a party, or by which RMS or any of its Affiliates is bound, or
to
which any of
the
assets or properties of RMS or of any of its Affiliates are
subject.
4.2 Representations
and
Warranties
of RGI.
Each
Person comprising
RGI hereby represents, warrants and covenants to RMS that:
(a) RGI
is an
entity duly organized, validly existing and in good standing
under the laws of the state of its organization, with full power to carry on
its
business
and activities as now being conducted;
(b) This
Agreement has been duly authorized, executed and delivered by RGI and represents
its binding obligation, enforceable against it in accordance with its
terms
and conditions. RGI has the corporate power and authority to enter into this
Agreement
and to perform its obligations hereunder. No other act, approval or proceeding
on its part is or will be required to authorize the execution and delivery
of
this Agreement, or the consummation of the transactions contemplated
hereby;
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
(c) The
execution and delivery by RGI of this Agreement will not, and the
fulfillment of and compliance by it with the terms, conditions and provisions
hereof will
not:
(i) conflict with any of the terms, conditions or provisions of the articles
or
certificate of organization or by-laws of it or any of its Affiliates, (ii)
violate any term, condition
or provision of, or require any consent, authorization or approval under, any
judicial
or arbitration judgment, order, award, writ, injunction or decree applicable
to
it or any of its Affiliates, or (iii) conflict with, result in a breach of,
constitute a default under (whether with or without the giving of notice or
the
lapse of time or both), or accelerate or permit the acceleration of the
performance required by, or require any consent, authorization or approval
under
any document, instrument, agreement or license to which
it
or any of its Affiliates is a party, or by which it or any of its Affiliates
is
bound, or to
which
any of its assets or properties or the assets or properties of any of its
Affiliates are subject;
(d) RGI
is
the sole and exclusive owner of, or has licensed rights in and
to,
the RGI Patent Rights and has the lawful right (with the express written
permission from the University of Southern California) to grant to RMS Group
the
license and rights granted in Section 3.1 herein;
(e) To
the
best of its knowledge, the RGI Patent Rights are valid and enforceable and
RGI
has not taken or failed to take any action which might result in their
invalidity and/or unenforceability against Third Persons, and RGI has received
no information
or claim to the effect that the RGI Patent Rights are going to be challenged,
are
invalid or are unenforceable;
(f) RGI
has
not received a notice or claim to the effect that the inventions subject to,
claimed by, or included within the RGI Patent Rights infringe, violate or
misappropriate the patent or trade secret rights of any Third Person;
and
(g) Exhibit
"2" to this Agreement is a schedule disclosing, to the extent that
RGI
is permitted to, all licenses or contracts of RGI with Third Persons, in effect
prior
to
the Effective Date, in which RGI has granted licenses of the RGI Patent Rights.
There
are
no licenses or contracts with Third Persons that are not listed in Exhibit
"2"
that have a material adverse effect on the rights granted to RMS in this
Agreement.
4.3
Indemnification.
(a) RMS
shall
indemnify, hold harmless and defend RGI, its directors, officers,
shareholders, employees, representatives, attorneys, Affiliates and agents
(each
such Person a "RGI Indemnitee") from and against any and all claims, suits,
losses,
damages, obligations, costs, fees and expenses (including reasonable attorneys'
and experts' fees and court costs) suffered or incurred by any RGI Indemnitee
arising out of, resulting from or otherwise concerning a breach by RMS of
any
of
RMS's representations and warranties contained in this Article 4.
(b) RGI
shall
indemnify, hold harmless and defend RMS Group, their respective
directors, officers, shareholders, employees, representatives, attorneys,
Affiliates
and agents (each such Person a "RMS Indemnitee") from and against any and
all
claims, suits, losses, damages, obligations, costs, fees and expenses (including
reasonable
attorneys' and experts' fees and court costs) suffered or incurred by any
RMS
Indemnitee arising out of, resulting from or otherwise concerning a breach
by
RGI of
any of
RGI's representations and warranties contained in this Article 4.
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
(c)
Any
RGI Indemnitee or RMS Indemnitee, as the case may be, seeking to be held
harmless, defended and indemnified in accordance with the provisions of Section
(a) or (b) of this Section 4.3 shall promptly notify RMS or RGI, as appropriate
(the "Indemnitor"), of any claim or suit brought against such RGI Indemnitee
or
RMS
Indemnitee in respect of which such RGI Indemnitee or RMS Indemnitee intends
to
invoke the provisions of this Section 4.3, although the failure to so notify
the
Indemnitor
shall not release such Indemnitor from its obligations under this Section 4.3
unless such Indemnitor shall have been materially prejudiced by such failure.
Such Indemnitor
shall indemnify, hold harmless and defend such RGI Indemnitee or RMS Indemnitee,
as the case may be, as above provided, and shall keep such RGI Indemnitee or
RMS
Indemnitee fully informed of the Indemnitor's defense and/or settlement
of such claim or suit. The RGI Indemnitee or RMS Indemnitee, as the case
may
be,
shall cooperate reasonably in the defense of such claim or suit, and shall
have
the
right, but no obligation, to participate in the defense thereof with counsel
of
such Person's choice at such Person's expense.
4.4 RMS
shall
indemnify, hold harmless and defend the RGI Indemnitees
from and against any and all claims, suits, losses, damages, obligations, costs,
fees and expenses (including reasonable attorneys and experts fees and court
costs) suffered or incurred by any RGI Indemnitee, arising out of, resulting
from, or otherwise concerning the development, manufacture, use or sale of
End
Products by RMS or any RMS Affiliate or any sub-licensee of any RMS Group
member, for any injury
of
any kind unless such claim or damage (a) is the direct result of a negligent
act
or
omission by RGI or (b) asserts that the RGI Patent Rights or RGI Technical
Information
infringes or misappropriates the rights of any Third Persons.
4.5 Survival.
The
provisions of this Article 4 shall survive the expiration
or termination of this Agreement in accordance with their respective terms
and
conditions.
5.
PROPRIETARY
INFORMATION
5.1
Proprietary
Information.
Subject
to the terms and conditions of this Article 5, RGI and the members of the RMS
Group, respectively, will treat and maintain the confidential and proprietary
business, patent prosecution and other data and information, including RGI
Technical Information, RMS Technical Information, and the non-public information
and documentation supplied by RMS to RGI and by RGI to RMS
pursuant to this Agreement (collectively, the "Proprietary Information"), of
the
other party
in
confidence, and will only use such Proprietary Information in furtherance of
this Agreement and the transactions and matters contemplated
herein.
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
5.2 Labeling.
The
receiving party shall include all proprietary and legal notices of the
disclosing party on all copies of the Proprietary Information of the disclosing
party, and shall not remove, delete or omit any proprietary or legal notices
from the Proprietary Information of the disclosing party.
5.3 Confidential
Disclosure.
Notwithstanding anything herein to the contrary,
RGI and RMS each may disclose Proprietary Information of the other party to
its
respective employees, agents, consultants, contractors and Affiliates, as the
case may be, provided that each such Person first undertakes to be likewise
bound by the duty and obligation of confidentiality and the restrictions on
use
agreed to herein.
5.4 Limitations.
Nothing
contained herein shall in any way restrict or impair
the right of RGI or RMS to use, disclose or otherwise deal with, as appropriate,
any
Proprietary Information of the other party:
(1) that
the
recipient can demonstrate was previously known to it;
(2) that
the
recipient can demonstrate by written records was independently developed
by it without access to or use of the Proprietary Information of the disclosing
party;
(3) that
is
publicly known when thus used, disclosed or otherwise dealt with, other
than through acts or omissions of the recipient;
(4) that
is
lawfully obtained by the recipient without confidentiality or use restrictions
from sources independent of the disclosing party;
(5) that
is
required to be disclosed to a governmental entity or agency in connection with
seeking any governmental or regulatory approval, or pursuant to the lawful
requirement or request of a governmental entity or agency; and/or
(6) that
the
recipient is required to disclose pursuant to lawful legal process or other
applicable law.
5.5 Return
of Proprietary Information.
Upon
the
expiration or termination
of this Agreement, at the written request of the disclosing party, the recipient
party
shall, within thirty (30) days following receipt of the request, (a) destroy
or
return to the
disclosing party all Proprietary Information received from the disclosing party,
and (b)
provide the disclosing party with a written notice that the Proprietary
Information has been
returned or destroyed. The recipient party may, however, retain one copy of
such
Proprietary Information for archival purposes in nonworking confidential
files.
5.6 Equitable
Relief.
The
parties agree that a remedy at law for breach
of
Sections 5.1 or 5.5 may be inadequate, and that the party seeking to enforce
Sections
5.1 or 5.5 shall be entitled, in addition to such other remedies as it may
have
at law
or
otherwise, to seek temporary or permanent injunctive relief and/or specific
enforcement for any breach or threatened breach thereof by the other party
without proof of any actual damages that have been or may be caused by such
a
breach.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
10
5.7
Survival.
The
provisions of this Article 5 shall survive the expiration
or termination of this Agreement in accordance with their respective terms
and
conditions.
6.
ROYALTIES,
ETC.
6.1 Running
Royalties.
In
consideration of the grant set forth in Section
3, subject to the terms and conditions of this Agreement including Sections
6.2
and
6.3
below, RMS shall pay to RGI a royalty of [***] percent ([***]%) of [***] percent
([***]%) of Net Sales of the RMS Group for End Products. Notwithstanding
the
foregoing, in no event shall RMS pay any royalty to RGI for any sale or transfer
of reagents
to RGI in accordance with Section 2.7.
6.2 Third
Party Licenses.
If
the
RMS Group determines that any End Product
or the use thereof infringes claims of an issued patent or patents other than
those in the RGI Patent Rights, RMS may negotiate with the owner of such
patent(s) for a license on such terms as RMS reasonably deems
appropriate.
6.3 Affiliates.
The Running Royalties provided in Article 6 shall be payable
by RMS with respect to the activities of RMS's Affiliates as well.
6.4 Statements
and Payments.
RMS
shall
deliver a quarterly statement
to RGI, indicating the Running Royalty payments due to RGI in respect of each
calendar quarter after the Effective Date, accompanied by payment of the
applicable
Running Royalty due. Each quarterly statement shall state the number of
End
Products sold or otherwise conveyed by RMS and its Affiliates to third parties
for such fiscal quarter and the Net Sales in that regard. The first quarterly
statement and payment shall be due within sixty (60) days after the close of
the
first calendar quarter following the Effective Date. Subsequent quarterly
statements shall be due within sixty (60) days following the close of each
subsequent calendar quarter.
6.5 Audits.
RMS
and
its Affiliates shall maintain regular and complete records
for a period of two (2) years after the later of (x) the receipt by RGI of
the
quarterly statement to which they pertain and (y) the expiration of the calendar
quarter to which they pertain, sufficient to enable verification of the accuracy
of all statements and reports made by RMS. Such records shall be maintained
at
RMS's regular place of business and shall be available for inspection and
auditing by RGI's outside accountants
on thirty (30) days notice during normal business hours; provided, however,
that
RGI shall not cause such an inspection and/or audit to occur more than once
in
any twelve (12) month period, and provided further that all such inspections
and
audits
shall be conducted so as not to unreasonably interfere with RMS's regular
business activities. Should any such audit reveal a payment short fall by RMS,
the amount
of
the short fall shall be paid promptly by RMS after the discovery thereof,
together with interest thereon calculated at the rate of one percent
(1%)
per
month from the
date
such payment should have been paid, or the maximum rate permitted by law if
such
rate
shall be lower than one percent (1%) per month.
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
6.6
Nondisclosure.
RGI
shall
hold the statements and reports contemplated
in Section 6.4 and any information acquired during any inspection and audit
conducted in accordance with Section 6.5 in confidence, and shall use such
statements,
reports and information solely for the purposes of (i) collecting any Running
Royalties
due it, and/or (ii) complying with the terms and conditions of this Agreement.
Nothing in this Section 6.6 shall be construed to preclude RGI from making
any
disclosures required by any governmental laws or regulations or by judicial
process.
7.
TERMINATION
7.1 Agreement
Expiration.
Except
as
otherwise provided in this Article
7, this Agreement, including the license grants contained in Article 3 herein,
shall continue until the date on which each and every application for patent
and
Claim of the RGI
Patent Rights has (i) expired, (ii) been disclaimed, (iii) been canceled,
abandoned or terminated, or (iv) been held invalid by a court of competent
jurisdiction, from which no further appeal is possible or has been taken within
the time period provided.
7.2 Termination
for Material Breach.
Either
party may terminate this Agreement, including the license grants contained
in
Article 3 herein, in the event that the other party (the "Breaching Party")
materially breaches a material provision of this Agreement, which breach is
not
substantially cured by the Breaching Party within one hundred
eighty (180) days after written notice of such breach by the terminating party
to the Breaching Party, provided that in the event of a material breach by
RMS
of any then undisputed payment obligation to RGI under Article 6 hereof, the
applicable period within which there shall be an opportunity to cure such a
breach shall be thirty (30) days after
the
date of such breach. Termination of this Agreement based upon a material
breach
hereof shall be without prejudice to any other rights and remedies that the
terminating party may have as a result of the default.
7.3 Termination
for Cause.
Either
party may terminate this Agreement
upon sixty (60) days written notice to the other party in the event of any
of
the following events: (a) Xxxxx Xxxxxxxxx ceases to be an executive officer
of
RGI, provided
that in such case, thirty (30) days written notice shall be deemed adequate;
(b)
RGI
is
dissolved or enters into a liquidating bankruptcy proceeding; or (c) RMS and
its
Affiliates discontinue its and their programs (which RMS represents is currently
known within RMS as SynergysDx) to commercialize diagnostics via collaboration
with third party pharmaceutical companies with respect to the development of
companion diagnostics for personalized medicine.
7.4 Termination
on Notice.
Neither
party may terminate this Agreement,
except pursuant to the provisions of Sections 7.2 or 7.3 hereof, during a period
of two (2) years from its Effective Date (the "Initial Term"). Thereafter,
the
Term of this Agreement shall automatically renew for one year periods, subject
to the following termination provisions:
(a)
either party may terminate this Agreement after the Initial Term upon
sixty (60) days written notice to the other party, provided, however, that
any
such termination
under this Section 7.4(a) shall be as to collaboration obligations, set out
in
Sections 2.1 and 2.2, arising thereafter and shall not affect any pre-existing
rights, licenses or obligations of the parties in relation to transactions
with
Third Persons or otherwise concerning any RGI Assays or Optimized Assays
developed up to the date of termination.
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) RMS
may
terminate this Agreement, including the provisions of Section
3.1, after the Initial Term upon sixty (60) days written notice to
RGI.
(c) if
a
collaboration agreement with a third party pharmaceutical company
cannot be concurrently terminated and therefore requires the participation
of
RGI
and
RMS, the Term of this Agreement shall be extended so as to meet the requirements
of such third party pharmaceutical company collaboration
transaction.
7.5
Effects
of Termination.
Termination
of this Agreement for any reason
shall not release either party from any liabilities or obligations set forth
in
this Agreement
which (i) the parties have expressly agreed shall survive any such termination,
(ii) remain to be performed, or (iii) by their nature are intended to be
applicable
following any such termination (e.g., Sections 2.7, 5, 10.3).
Moreover,
after Termination, RMS shall continue to supply to RGI, in accordance with
Section 2.7 hereof,
reagents that have been developed by RMS, for research purposes with respect
to
specific RGI collaborations with pharmaceutical companies, for the lesser of
(a)
the duration
of then ongoing pharmaceutical research by RGI in that regard, and (b) five
(5)
years.
8.
NOTICES
Any
notice given pursuant to this Agreement shall be in writing, and shall be deemed
to have been duly given if delivered in person or sent by confirmed facsimile
transmission
or by certified, registered or overnight express mail or courier service,
postage,
mailing and delivery expenses prepaid, to the address or facsimile number which
the party to be notified has specified in writing to the other parties hereto,
from time
to
time, as the address or facsimile number to which notices and requests are
to be
delivered
to it under this Agreement. A notice shall be considered to be effective upon
actual receipt by the party to be notified. Any party may amend its address
or
facsimile number for notices by so notifying the other parties in writing of
such change. The addresses
and facsimile numbers for notices to each party are as follows:
If
to RGI:
|
If
to RMS:
|
Response
Genetics, Inc.
|
Roche
Molecular Systems, Inc.
|
0000
Xxxxxxx Xxxxxx
|
0000
Xxxxxxxx Xxxxx
|
Xxx
Xxxxxxx, XX 00000
|
Xxxxxxxxxx,
Xxxxxxxxxx 00000
|
Attn:
Xxxxxxxx Xxxxxxxxx, CEO
|
Attention:
General Counsel
|
Fax:
(000) 000-0000
|
Fax:
(000) 000-0000
|
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
9. WAIVER
OF CONSEQUENTIAL DAMAGES. ETC.
Except
as
otherwise contemplated in Articles 4, 5 and 9 of this Agreement, neither party
shall be liable for indirect, consequential or punitive damages (including
loss
of
income, profits or goodwill) arising under, relating to or otherwise concerning
this Agreement
whether based on an action or claim in contract, equity, negligence, tort
(except for intentional misconduct) or otherwise, and each party hereby waives
any claims
with respect to such types of damages. RGI and RMS expressly acknowledge
that
the
exclusions contained in this Section have been the subject of active and
complete negotiation between the parties and represent the parties' agreement
based upon
the
level of risk to RMS and RGI associated with their respective obligations under
this
Agreement and the payments provided to RGI hereunder.
10. GENERAL
PROVISIONS
10.1 Assignment;
Binding Effect. Etc. This
Agreement shall be binding
upon and inure to the benefit of RGI and RMS and their respective permitted
successors and assigns. RMS may assign its rights and licenses under this
Agreement to any Affiliate or to any successor to all or substantially all
of
the business or assets of RMS without the prior written consent of RGI, provided
such Affiliate or successor assumes in writing the obligations of RMS under
this
Agreement. Affiliates of RMS and of
RGI,
RMS Indemnitees, and RGI Indemnitees are intended third party beneficiaries
of
this
Agreement to the extent expressly provided herein. Any permitted assignment
or
transfer
of this Agreement by either party shall not relieve or release such party from
any
of
its duties or obligations under this Agreement. RGI may assign or transfer
the
RGI
Patent Rights to any successor to all or substantially all of the business
assets of RGI. If RGI wishes to assign this Agreement to any other party, RGI
shall first notify RMS, and the parties shall discuss the proposed assignment
in
good faith for a period of
not
more than 14 days in order to avoid assignment of this Agreement to a competitor
of RMS or to any party that could not reasonably fulfill the obligations of
RGI
hereunder. Each
and
every permitted successor and assign to or of the interests of either party
to
this Agreement shall hold such interests subject to the terms, conditions and
provisions of this Agreement.
10.2 Entire
Agreement.
This
Agreement constitutes the full and entire understanding
and agreement between the parties with regard to the subject matter hereof,
and supersedes all prior or contemporaneous proposals, oral or written,
understandings, representations, conditions and other communications between
the
parties
relating to such subject matter. Amendments hereof shall not be binding upon
either
party unless expressly agreed to in writing by both parties.
10.3 Governing
Law.
This
Agreement and the rights and obligations of the
parties hereunder shall be governed by and interpreted in accordance with the
laws of
the
State of California, except that its conflict of laws rules shall not apply.
The
parties
hereby consent to the personal jurisdiction of, and agree that any legal
proceeding
with respect to or arising under this Agreement shall be brought exclusively
in
a state court of the State of California or a United States District Court
sitting in California
if such court has subject matter jurisdiction.
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
10.4 Interpretation.
In
any
interpretation of this Agreement, it shall be deemed
that this Agreement was prepared jointly by the parties, and no ambiguity shall
be
construed or resolved against either party on the premise or presumption that
such party was responsible for drafting this Agreement.
10.5 Severability.
If
any
provision of this Agreement is declared or found to be illegal, unenforceable
or
void, then both parties shall be relieved of all obligations arising under
such
provision, but only to the extent that such provision is illegal,
unenforceable or void. Further, this Agreement shall be deemed amended by
modifying
such provision to the extent necessary to make it legal and enforceable while
preserving
its intent or, if that is not possible, by substituting therefor another
provision that is legal and enforceable and achieves the same intended
objective. Each provision not so affected shall be enforced to the extent
permitted by law.
10.6 Independent
Contractors.
The
parties to this Agreement are independent contractors and this Agreement shall
not be construed to create any partnership,
franchise, fiduciary or employment relationship. In addition, nothing in this
Agreement
shall be deemed to appoint or authorize one party to act as an agent or
other
representative of the other party or to assume or incur any liability or
obligation in the
name
of or on behalf of the other party.
10.7 Singular/Plural.
Whenever
in the context it appears appropriate, each term stated either in the singular
or the plural shall include both the singular and the
plural.
10.8 Incorporation
of Recitals and Exhibits.
The
recitals contained in this
Agreement and the exhibits attached hereto are hereby incorporated into this
Agreement and made a part hereof.
10.9 Headings.
Article,
section and subsection headings in this Agreement
are included for convenience of reference only and shall not constitute a
part
of
this Agreement for any other purpose or be given any substantive
effect.
10.10 Counterparts.
This
Agreement and any amendments, waivers, or consents
hereto may be executed in any number of counterparts, and by different
parties
in separate counterparts, each of which when so executed and delivered shall
be
deemed an original, but all such counterparts together shall constitute but
one
and the
same
agreement.
10.11 Media
Releases.
All
media
releases, public announcements and public disclosures by RGI or members of
the
RMS Group shall be coordinated with and approved
in writing by the other party prior to the release thereof.
10.12 Force
Majeure.
If
the
performance of this Agreement or any obligation
hereunder is prevented or interfered with by reason of fire or other casualty
or
accident, strikes or labor disputes, war or other violence, any law, order,
proclamation, regulation, ordinance, demand or requirement of any governmental
agency, or any other
act
or condition whatsoever beyond the reasonable control of the parties, the party
whose performance is so affected, upon giving prompt notice to the other party,
shall be excused
from such performance or obligation to the extent and for the duration that
it
is so affected. However, the party so affected shall take all reasonable steps
to avoid or remove
such conditions and causes of nonperformance, and shall resume performance
hereunder
with dispatch when such causes are removed.
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
10.13 Further
Acts.
Each
party shall do, or cause to be done, all such further
acts, and shall execute,.acknowledge and deliver, or cause to be executed,
acknowledged and delivered, any and all such further documentation as the other
party reasonably requires to carry out the purposes of this
Agreement.
10.14 Waiver.
A
waiver
by either of the parties of any of the covenants, conditions or agreements
affecting the other party or any breach thereof shall not be construed to be
a
waiver of any succeeding breach thereof or of any other covenant, condition
or agreement contained herein.
10.15 Performance
by Affiliates.
To
the
extent that any term or provision
of this Agreement contemplates, permits or requires performance by any Affiliate
of a party, such party shall cause such Affiliate to perform each and every
obligation of such party under this Agreement in accordance with the terms
and
conditions
hereof, provided that any such performance shall not relieve the party hereto
of
its
own obligations and duties hereunder.
IN
WITNESS WHEREOF, the
parties have executed this Agreement effective
as of the Effective Date.
RESPONSE GENETICS, INC. | ROCHE MOLECULAR SYSTEMS, INC. | |||
By: | By: | |||
Title |
PRESIDENT & CEO |
Title |
SVP Commercial Operations |
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
EXHIBIT
"1"
RGI
PATENT RIGHTS
U.S.
Application or Patent
Number
|
Title
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
|
||
[***]
|
[***]
|
|
[***]
|
[***]
|
|
|
||
[***]
|
[***]
|
|
|
||
Foreign
Applications
|
Title
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
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.
Foreign
Applications
|
Title
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
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.
EXHIBIT
"2"
LIST OF LICENSES AND CONTRACTS
1. |
[***]
|
2. |
[***]
|
3. |
[***]
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.