CERTAIN
INFORMATION WITHIN THIS EXHIBIT HAS BEEN OMITTED AND THE NON-PUBLIC
INFORMATION HAS BEEN FILED WITH THE SECURITIES EXCHANGE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
OMITTED PORTIONS.
THIS LICENSE
AGREEMENT (this “Agreement”) dated as of
September 30, 2005 (the “Effective Date”), is
entered into between Abaxis, Inc. a California corporation
(“Abaxis”), having a place of business at 3240 Whipple
Road, Union City, CA, 94587, and Cepheid, a California corporation
(“Cepheid”), having a place of business at 904
Caribbean Drive, Sunnyvale, CA 94089.
WHEREAS, Abaxis
owns or has rights in certain technology regarding lyophilized
beads or reagent spheres.
WHEREAS, Cepheid
desires to obtain a non-exclusive worldwide license under
Abaxis’ rights in such technology to develop and
commercialize products for use in nucleic acid based amplification
assays for diagnostic applications.
NOW, THEREFORE, in
consideration of the foregoing premises and the mutual covenants
herein contained, the parties agree as follows:
1.1 “
Affiliate ” shall mean, with respect to any Person,
any other Person which directly or indirectly controls, is
controlled by, or is under common control with, such Person. A
Person shall be regarded as in control of another Person if it
owns, or directly or indirectly controls, at least fifty percent
(50%) of the voting stock or other ownership interest of the other
Person, or if it directly or indirectly possesses the power to
direct or cause the direction of the management and policies of the
other Person by any means whatsoever.
1.2 “
Confidential Information ” shall mean, with respect to
a party, all information of any kind whatsoever, and all tangible
and intangible embodiments thereof of any kind whatsoever, which is
disclosed by such party to the other party and is marked,
identified as or otherwise acknowledged to be confidential at the
time of disclosure to the other party. Notwithstanding the
foregoing, Confidential Information of a party shall not include
information which the other party can establish by written
documentation (a) to have been publicly known prior to
disclosure of such information by the disclosing party to the other
party, (b) to have become publicly known, without fault on the
part of the other party, subsequent to disclosure of such
information by the disclosing party to the other party, (c) to
have been received by the other party at any time from a source,
other than the disclosing party, rightfully having possession of
and the right to disclose such information, (d) to have been
otherwise known by the other party prior to disclosure of such
information by the disclosing party to the other party, or
(e) to have been
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The symbol
[***] is used to indicate that a portion of the exhibit has been
omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect
to the omitted portion.
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independently
developed by employees or agents of the other party without access
to or use of such information disclosed by the disclosing party to
the other party.
1.3 “
Cepheid Foreign Distributor ” shall mean a distributor
authorized by Cepheid to sell outside of the United States,
Cepheid’s Licensed Products provided by Cepheid to the
distributor in their final package form and without any
re-packaging or modification to the Licensed Product by the
distributor.
1.4 “
District Court Action ” shall mean the lawsuit
asserting claims of infringement against Cepheid under multiple
United States patents owned by Abaxis in the action of Abaxis,
Inc., v. Cepheid, Inc. , Case No. C 05-3618 PVT, pending
as of the Effective Date in the United States District Court for
the Northern District of California.
1.5 “
Field of Use ” shall mean nucleic acid based
amplification assays excluding for use in molecular biology
research and isothermal rolling circle amplification.
1.6 “
Licensed Patent ” U.S. patents and patent applications
claiming priority from the U.S. patent application
No. 07/747,179 including any reissues, reexaminations,
extensions and continuations-in-part, and specifically including
U.S. Patent Nos. 6,251,684, 5,998,031, 5,776,563, 5,624,597 and
5,413,732, and their corresponding foreign patents and patent
applications.
1.7 “ Net
Sales ” shall mean, with respect to any Licensed Product,
the gross invoiced sales price of such Licensed Product by Cepheid,
its Affiliates, or distributors billed to third party customers,
less (a) credits, allowances, discounts and rebates to, and
chargebacks from the account of, such independent customers for
spoiled, damaged, out-dated, rejected or returned Licensed Product;
(b) actual freight and insurance costs incurred in
transporting such Licensed Product to such customers;
(c) cash, quantity and trade discounts and other price
reductions; (d) sales, use, value-added and other direct taxes
incurred; and (e) customs duties, surcharges and other
governmental charges incurred in connection with the exportation or
importation of such Licensed Product. For avoidance of doubt, Net
Sales shall not include sales among Cepheid, its Affiliates and
distributors for resale, provided that Net Sales shall include the
amounts invoiced by Cepheid, Affiliates or distributors, as the
case may be, on the resale of such Licensed Product in arms length
transactions to third party customers. Notwithstanding the
foregoing, Net Sales with respect to sales through Cepheid Foreign
Distributors taking place outside of the United States shall be the
amount invoiced between Cepheid and Cepheid Foreign Distributors.
Furthermore, Net Sales with respect to sales through Northrop
Grumman Security Systems, LLC (NGSS) to the United States
Postal Service shall be the amount invoiced between Cepheid and
NGSS.
1.8 “
Person ” shall mean an individual, corporation,
partnership, limited liability company, trust, business trust,
association, joint stock company, joint venture, pool, syndicate,
sole proprietorship, unincorporated organization, governmental
authority or any other form of entity not specifically listed
herein.
1.9 “
Licensed Products ” shall mean any product, the
manufacture, use, sale, offer for sale, or importation of which,
but for the licenses granted herein under this Agreement,
would
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The symbol
[***] is used to indicate that a portion of the exhibit has been
omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect
to the omitted portion.
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infringe a
Valid Claim of the Licensed Patents. Appendix 1 attached
hereto provides a list of the Licensed Products as of the Effective
Date of this Agreement.
1.10 “
Licensed GeneXpert Product ” shall mean any Licensed
Product that contains Cepheid’s self contained cartridge
(also called GeneXpert cartridge) as described and offered by
Cepheid at www.cepheid.com as of the Effective Date of this
Agreement and any follow on versions made thereon. Appendix 2
attached hereto provides a list of the Licensed GeneXpert Products
as of the Effective Date of this Agreement.
1.11 “
Licensed GeneXpert Product Unit ” shall mean a single
GeneXpert cartridge of Licensed GeneXpert Product that is designed
for a single use to detect the presence or absence of one or more
analytes in a single sample of biological material to be
tested.
1.12 “
Territory ” shall mean worldwide.
1.13 “
Valid Claim ” shall mean a claim of an issued and
unexpired patent of the Licensed Patents that (i) has not been
revoked or held unenforceable or invalid by a decision of a court
or governmental agency of competent jurisdiction from which no
appeal can be taken or has been taken within the time allowed for
appeal; (ii) has not been abandoned, or admitted to be invalid
or unenforceable through reissue or disclaimer or
otherwise.
REPRESENTATIONS AND
WARRANTIES
Each party hereby
represents and warrants to the other party as follows:
2.1 Corporate
Existence . Such party is a corporation duly organized, validly
existing and in good standing under the laws of the state in which
it is incorporated.
2.2
Authorization and Enforcement of Obligations . Such party
(a) has the corporate power and authority and the legal right
to enter into this Agreement and to perform its obligations
hereunder, and (b) has taken all necessary corporate action on
its part to authorize the execution and delivery of this Agreement
and the performance of its obligations hereunder. This Agreement
has been duly executed and delivered on behalf of such party, and
constitutes a legal, valid, binding obligation, enforceable against
such party in accordance with its terms.
2.3 No
Consents . All necessary consents, approvals and authorizations
of all governmental authorities and other Persons required to be
obtained by such party in connection with this Agreement have been
obtained.
2.4 No
Conflict . The execution and delivery of this Agreement and the
performance of such party’s obligations hereunder (a) do
not conflict with or violate any requirement of applicable laws or
regulations, and (b) do not conflict with, or constitute a
default under, any contractual obligation of it.
2.5
Representation by Abaxis. Abaxis hereby represents and
warrants to Cepheid that as of the Effective Date of this
Agreement, (a) Abaxis owns all right, title, and interest in
and to the
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The symbol
[***] is used to indicate that a portion of the exhibit has been
omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect
to the omitted portion.
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Licensed
Patents and has all necessary rights to grant the license under the
Licensed Patents as set forth in Section ARTICLE 3,
(b) Abaxis has received no written notices or claims that the
practice of the Licensed Patents violates, infringes or
misappropriates any third party’s intellectual property
rights, and (c) Abaxis does not own or have rights to any
patents or patent applications that are not included in the
Licensed Patents and the rights of which are required to practice
the license granted under this Agreement as set forth in
Section ARTICLE 3.
2.6 Disclaimer
of Warranties . EXCEPT FOR THE WARRANTIES EXPRESSLY PROVIDED IN
THIS AGREEMENT, NEITHER PARTY MAKES, AND EACH PARTY EXPRESSLY
DISCLAIMS, ANY OTHER REPRESENTATIONS OR WARRANTIES TO THE OTHER
PARTY WITH RESPECT TO THE LICENSED PATENTS OR OTHERWISE UNDER THIS
AGREEMENT, EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION,
THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE, OR NONINFRINGEMENT.
3.1 Licensed IP
Rights . Subject to the terms and conditions of this Agreement
and during the term of this Agreement, Abaxis hereby grants to
Cepheid a non-exclusive, non-transferable, royalty-bearing license,
with the limited right to sublicense solely in accordance with
Section 3.2 herein, under the Licensed Patents to make, have
made, import, use, distribute and sell Licensed Products solely
within the Field of Use and within the Territory, provided that any
OEM arrangements other than CSR customers shall only be permitted
with prior written consent by Abaxis and shall be subject to the
proposed OEM being licensed under the Licensed Patents under the
terms and conditions negotiated in good faith between the proposed
OEM distributor and Abaxis. For avoidance of doubt, sales of
Licensed GeneXpert Products by Cepheid in the relationship of
Cepheid with Applied Biosystems (ABI) shall be considered
licensed under this Agreement. The relationship referred to with
ABI is specifically an arrangement whereby ABI provides wet
reagents to Cepheid, which are manufactured into GeneXpert
cartridges by Cepheid, which cartridges are owned by ABI, and which
completed cartridges are distributed by Cepheid and its
distributors. Sales by Cepheid under this relationship with ABI
shall not be considered an OEM arrangement under this
Agreement.
3.2
Sublicenses . Unless specifically permitted by Abaxis in
writing, Cepheid shall not grant any sublicenses under the license
granted in Section 3.1 to any third party, with the sole
exception of the limited right to grant sublicenses to Cepheid
Affiliates in the Field of Use. Cepheid shall deliver a copy of
each permitted sublicense under this Agreement to Abaxis promptly
after execution of the same. Each permitted sublicense shall be
subject to the terms and conditions of this Agreement, except that
sublicenses of Affiliates shall not require an up front license fee
or maintenance fees.
3.3 License to
Additional Products. Any product by Cepheid that becomes a
Licensed Product after the Effective Date of this Agreement maybe
added to the list of Licensed Products under Appendix 1
attached hereto via amendment to the Appendix 1, provided that
Cepheid notifies Abaxis of such added Licensed Product in writing
and Cepheid hereby agrees that such
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The symbol
[***] is used to indicate that a portion of the exhibit has been
omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect
to the omitted portion.
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added Licensed
Product is subject to the same royalty term as set forth under
Section 4.2 in this Agreement.
4.1 Initial
License Fee. In consideration for the licenses granted to
Cepheid herein, Cepheid shall pay Abaxis [***] on the Effective
Date of this Agreement.
4.2 Royalty
Rate . In consideration for the licenses granted to Cepheid
herein, during the term of this Agreement, Cepheid shall pay
royalties to Abaxis
4.3 License
Maintenance Fee . In consideration for the licenses granted to
Cepheid herein, during the term of this Agreement, Cepheid shall
pay Abaxis a license maintenance fee of [***] per year payable by
December 31 of each year; provided that such license
maintenance fee is creditable against any royalties due during such
calendar year. Such minimum royalty shall be prorated for the
calendar year of 2005.
ROYALTY REPORTS AND
ACCOUNTING
5.1 Royalty
Reports . During the term of this Agreement, Cepheid shall
furnish to Abaxis a quarterly written report showing in reasonably
specific detail , (a) the gross sales of each Licensed Product
sold by Cepheid, its Affiliates and its distributors, (except sales
by Cepheid Foreign Distributors and NGSS to the US Postal Service)
in the Territory during the reporting period and the calculation of
Net Sales from such gross sales; (b) the royalties payable in
United States dollars, if any, which shall have accrued hereunder
based upon Net Sales of each Licensed Product; (c) the
withholding taxes, if any, required by law to be deducted in
respect of such sales; and (d) the exchange rates used in
determining the amount of United States dollars. With respect to
sales of Licensed Products invoiced in United States dollars, all
amounts shall be expressed in United States dollars. With respect
to sales of Licensed Products invoiced in a currency other than
United States dollars, all amounts shall be expressed in
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