SETTLEMENT AND CROSS-LICENSE
AGREEMENT
This Settlement
and Cross-License Agreement (this “Agreement”) is made
and entered into between and among Idaho Technology, Inc.
(“Idaho Technology”); the University of Utah Research
Foundation (“Utah Research Foundation”); and Cepheid, a
California corporation (“Cepheid”) as of the date first
set forth above.
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A.
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Idaho Technology and the Utah
Research Foundation (collectively hereafter, “Idaho
Technology Plaintiffs”) claim to own and/or exclusively
license certain patent rights including rights to grant
sub-licenses in the fields of Real-Time PCR, Rapid PCR
Amplification Methods, and Melting Curve Analysis.
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B.
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Idaho Technology Plaintiffs allege
that Cepheid infringes certain patents, and has filed a lawsuit
styled, “Idaho Technology, Inc. and the University of Utah
Research Foundation v. Cepheid,” Case No. 2:05CV01063TS,
pending in the United States District Court for the District of
Utah (the “Utah Litigation”). In the Utah Litigation,
Idaho Technology Plaintiffs specifically allege Cepheid’s
infringement of U.S. Patent Nos. 6,787,338 and 6,569,627; and
claims 76 and 77 of U.S. Patent No. 6,174,670, relative to
products including Cepheid’s GeneXpert® and
SmartCycler® devices and kits identified as the
“IDI-Strep B Test.”
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C.
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The
parties now wish to settle the Utah Litigation, on terms and
conditions agreeable to all parties, including the payment by
Cepheid of monetary consideration to Idaho Technology and the grant
of rights in certain patents and patent applications by Idaho
Technology to Cepheid and by Cepheid to Idaho Technology, as
specified below.
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Accordingly, in
exchange for good and valuable consideration, the receipt and legal
adequacy of which is expressly acknowledged, the parties hereby
covenant and agree as follows:
Idaho
Technology Licensed Patents
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1.
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“Idaho Technology Licensed
Patents” shall mean U.S. Patent Nos. 6,787,338; 6,503,720 and
6,303,305, pending U.S. Patent Applications Nos. 10/843,075 and
10/891,161, and all continuations, divisions, CIPs, and respective
foreign counterparts thereof. Idaho Technology Licensed Patents
shall also include claims 9, 10, 11, 56, 76, 80 and 107 of U.S.
Patent No. 6,174,670, claims of
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substantially
the same scope in foreign counterparts, and claims of
continuations, divisions, CIPs, and other patents claiming priority
from U.S. Patent No. 6,174,670, but only to the extent
necessary to practice claims 9, 10, 11, 56, 76, 80 or 107 of U.S.
Patent No. 6,174,670, U.S. Patent Nos. 6,787,338; 6,503,720
and 6,303,305, or pending U.S. Patent Applications Nos. 10/843,075
and 10/891,161.
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2.
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“Cepheid Instrument”
means a thermal cycling device or instrument marketed, distributed,
sold, leased or otherwise transferred by Cepheid that:
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a.
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is
primarily intended for use in the automated performance of the
polymerase chain reaction (PCR) process;
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b.
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has
one or more positions, each for receiving a single reaction vessel
having a reaction volume no larger than 100 microliters, wherein
the temperature profile for thermal cycling each reaction can be
controlled independently of any other reaction, regardless of
whether the reactions are thermal cycled simultaneously,
sequentially or otherwise;
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c.
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for
such device or instrument that has more than one reaction vessel,
is capable of simultaneously thermal cycling all reaction vessels
wherein each vessel is controlled independently of the others
during such simultaneous cycling;
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d.
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may
optionally include use of a micro-array of nucleic acid reaction
locations within a reaction vessel, wherein the reaction vessel and
micro-array are arranged such that each location in the micro-array
is exposed to the same, common, reagent environment in the reaction
vessel, and wherein the micro-array is located or specifically
configured to be located within a reaction vessel that is
proprietary to Cepheid;
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e.
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that but for the license granted in
paragraph 4 below, would infringe upon (including contributory
infringement) or induce infringement of, one or more of the Idaho
Technology Licensed Patents; and
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f.
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is
marketed, distributed, sold, leased or otherwise transferred using
trademarks owned by Cepheid.
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For purposes of
this Agreement, and by way of example, Cepheid’s current
SmartCycler® and GeneXpert® instruments are
“Cepheid Instruments,” whereas air thermal cyclers
having a carousel (e.g. Idaho Technology’s R.A.P.I.D.®,
Roche’s LightCycler®, and Corbett’s Rotor-Gene),
microtiter plate-based thermal cyclers (e.g. ABI’s 2720,
9700, and 9800), and flexible pouch-based thermal cyclers wherein
the sample is moved within the pouch between multiple temperature
zones (e.g. Idaho Technology’s RAZOR® and Iquum’s
Liat®) are not “Cepheid Instruments.”
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3.
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“Cepheid Licensed Kits”
means kits:
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a.
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that include one or more PCR
reagents (including but not limited to polymerases, dNTPs, primers,
probes, dyes, buffers, and instructions for use);
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b.
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that but for the license granted in
paragraph 4 below, would infringe upon (including contributory
infringement) or induce infringement of, one or more of the Idaho
Technology Licensed Patents;
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c.
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wherein such PCR reagents are
packaged in or marketed to be used with a reaction vessel
proprietary to Cepheid that is configured to be received
exclusively in a thermal cycling position of a Cepheid Instrument;
and
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d.
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are
marketed, distributed, sold or otherwise transferred (i)
exclusively using trademarks owned by Cepheid or (ii) using
trademarks owned by Cepheid and trademarks owned by an exclusive
Cepheid distributor, provided that (A) Cepheid’s
trademarks shall be the primary and dominant marks in terms of size
and placement, and (B) the exclusive Cepheid
distributor’s trademarks shall be secondary and subordinate
in terms of size and placement.
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4.
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Grant by Idaho Technology –
Subject to paragraph 10 below, Idaho Technology hereby grants to
Cepheid and its Affiliates the world-wide, non-exclusive,
fully-paid up, perpetual, royalty-free, non-terminable and
irrevocable right and license to make, have made, use, sell, offer
to sell, have sold, import, and export Cepheid Instruments and
Cepheid Licensed Kits pursuant to the Idaho Technology Licensed
Patents (the “Cepheid License”). Additionally, Idaho
Technology Plaintiffs release Cepheid for any claims of past
infringement of the Idaho Technology Licensed Patents and all of
the claims of U.S. Patent Nos. 6,569,627 and 6,174,670, but Idaho
Technology grants no future rights in the Cepheid License under
U.S. Patent No. 6,569,627, and future rights under the Cepheid
License are only granted in claims 9, 10, 11, 56, 76, 80 and 107 of
U.S. Patent No. 6,174,670. Solely with respect to Cepheid
Instruments and Cepheid Licensed Kits manufactured, distributed or
sold by Cepheid (including by and through its distributors), Idaho
Technology Plaintiffs also release Cepheid’s distributors and
customers for any claims of past infringement of the Idaho
Technology Licensed Patents and all of the claims of U.S. Patent
Nos. 6,569,627 and 6,174,670.
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In
addition, Idaho Technology covenants not to sue Cepheid for
infringement of any claims in continuations, divisions, CIPs and
foreign counterparts of U.S. Patent Nos. 6,569,627 and 6,174,670
(the ‘627 and ‘670 patents) issued on or after the
Effective Date, and other patents issued on or after the Effective
Date claiming priority from the ‘627 or ‘670 patent or
the applications upon which such patents are based; provided
, however , that (a) such covenant not to sue extends solely
to the extent that such Cepheid Instruments and Cepheid Licensed
Kits as listed and described in the “Product
Specifications” (as such quoted term is defined below),
would, but for the Cepheid License, infringe upon (including
contributory infringement) or induce infringement of, one or more
of the Idaho Technology Licensed Patents; and (b) such
covenant not to sue shall not extend to, and expressly
excludes, any of the following items, services or processes:
(i) FRET hybridization probe pairs, (ii) SYBR® Green
I, (iii) LCGreen® I, LCGreen® Plus, (iv)
SimpleProbes®, (v) high resolution melting using a
saturation dye and/or an unlabeled probe (as defined in U.S. Patent
Application Publication Nos. 2005/0233335 and 2006/0019253),
(vi) all claims of U.S. Patent No. 6,174,670 not
specifically included in the Idaho Technology Licensed
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Patents, or
(vii) any additional nucleic acid detection method wherein the
detection means or use thereof is proprietary to Idaho Technology
and that is first filed, first sold, first offered for sale, or for
which rights are first acquired by Idaho Technology after the
Effective Date.
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For
the avoidance of doubt, in the practice of the Idaho Technology
Licensed Patents, Cepheid’s use of TaqMan® probes,
Scorpion® probes, and other detection moieties for which use
is not otherwise proprietary to Idaho Technology is specifically
included within the Cepheid License.
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For
purposes of this Agreement, “Affiliate” shall mean any
person, firm, business, corporation, limited liability company or
other form of legal entity controlled by, under common control
with, or controlling, the party. For these purposes,
“control” shall refer to the ownership, directly or
indirectly, of at least 50% of the voting securities or other
ownership interests of a person or entity.
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For
purposes of this Agreement, “Product Specifications”
shall mean the product and software specifications, information and
other data disclosed by Cepheid to Idaho Technology, pursuant to
the Mutual Non-Disclosure Agreement referenced in paragraph 39
below, through a password-protected electronic data room. The
Product Specifications shall be, and hereby are, incorporated by
reference as if set forth verbatim herein, and shall be maintained
for reference purposes as described in paragraph 39 below. Cepheid
represents and warrants that the Product Specifications accurately
represent the Cepheid Instruments and Cepheid Licensed Kits as of
the date first set forth above.
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5.
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Cepheid Licensed Patents means and
includes: U.S. Patent Nos. 6,713,297; 6,783,934; 6,911,327; and
6,942,971, plus any and all continuations, divisions, CIPs, foreign
counterparts and other patents claiming priority from said patents
or the applications upon which such patents are based, including
pending U.S. Patent Application No. 11/225,247.
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6.
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“Idaho Technology
Products” means a device, instrument or software used,
marketed, distributed, sold, leased or otherwise transferred by
Idaho Technology that but for the Idaho Technology License below,
would infringe (including contributory infringement) or induce
infringement of one or more claims of any of the Cepheid Licensed
Patents.
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7.
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Grant by Cepheid – Cepheid
hereby grants to Idaho Technology and its Affiliates the
world-wide, non-exclusive, fully-paid up, perpetual, royalty-free,
non-terminable and irrevocable right and license to make, have
made, use, sell, offer to sell, have sold, import, and export Idaho
Technology Products pursuant to the Cepheid Licensed Patents (the
“Idaho Technology License”). Additionally,
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Cepheid
releases Idaho Technology for any claims of past infringement of
the Cepheid Licensed Patents.
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8.
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It
is the intent of the parties to allow Cepheid to exercise its
rights and enjoy the practical benefits of the Cepheid License and
covenant not to sue, and for Cepheid’s distributors to
distribute and sell as contemplated by the “have sold”
rights under the Cepheid License, unhindered by other intellectual
property rights that Idaho Technology has the right to license or
sublicense. To that end, but only to that end, and without
expanding the scope of the Cepheid License or covenant not to sue,
Idaho Technology represents and warrants that it does not, as of
the date first set forth above, have the power to license or
sublicense any other patents or currently pending patent
applications that would materially block Cepheid from the exercise
of any claim of the Cepheid License (“Idaho Technology
Blocking Patents”).
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9.
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Without expanding the scope of the
Cepheid License, Idaho Technology hereby grants to Cepheid, on a
world-wide, non-exclusive, fully paid-up, royalty-free basis, a
further license and covenant-not-to-sue Cepheid for any such Idaho
Technology Blocking Patents, but only insofar as not to materially
block Cepheid from the exercise of the Cepheid License (the
“Cepheid Additional Licenses”). Further, solely with
respect to the sale or other distribution of Cepheid Instruments or
Cepheid Licensed Kits by Cepheid’s distributors under the
“have sold” rights of the Cepheid License, Idaho
Technology hereby covenants not to sue Cepheid’s distributors
for infringement of any such Idaho Technology Blocking
Patents.
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10.
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Notwithstanding anything to the
contrary in this Agreement, Idaho Technology’s covenants not
to sue and any licenses or other rights granted by Idaho Technology
under this Agreement (specifically including the covenants not to
sue and licenses or rights under paragraphs 4, 9, 12 and 23), shall
not extend to, and expressly exclude any right of Cepheid or any
third party to make, have made, use, sell, offer to sell, have
sold, import, or export, or to recommend to users or prospective
users of any Cepheid Instrument or Cepheid Licensed Kits, any of
the following items, services or processes: (a) FRET
hybridization probe pairs, (b) SYBR® Green I,
(c) LCGreen® I, LCGreen® Plus, (d)
SimpleProbes®, (e) high resolution melting using a
saturation dye and/or an unlabeled probe (as defined in U.S. Patent
Application Publication Nos. 2005/0233335 and 2006/0019253),
(f) all claims of U.S. Patent No. 6,174,670 not
specifically included in the Idaho Technology Licensed Patents, or
(g) any additional nucleic acid detection method wherein the
detection means or use thereof is proprietary to Idaho Technology
and that is first filed, first sold, first offered for sale, or for
which rights are first acquired by Idaho Technology after the
Effective Date (the “Excluded Matters”).
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11.
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It
is the intent of the parties to allow Idaho Technology to exercise
the Idaho Technology License, unhindered by other intellectual
property rights that Cepheid has the right to license or
sublicense. To that end, but only to that end, and without
expanding the scope of the Idaho Technology License, Cepheid
represents and warrants that it does not have the power to license
or sublicense any other patents or currently pending patent
applications that would materially block Idaho Technology from the
exercise of the Idaho Technology License (“Cepheid Blocking
Patents”).
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12.
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Without expanding the scope of the
Idaho Technology License, Cepheid hereby grants to Idaho Technology
on a world-wide, non-exclusive, fully paid-up, royalty-free basis,
a further license and covenant-not-to-sue Idaho Technology for any
such Cepheid Blocking Patents, but only insofar as not to
materially block Idaho Technology from the exercise of any claim of
the Idaho Technology License (the “Idaho Technology
Additional Licenses”). Further, solely with respect to sales
or other distribution by Idaho Technology’s distributors
under the “have sold” rights of the Idaho Technology
License, Cepheid hereby covenants not to sue Idaho
Technology’s distributors for infringement of any such
Cepheid Blocking Patents.
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13.
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Cepheid covenants and agrees that
any Cepheid Instruments and any Cepheid Licensed Kits manufactured,
marketed, distributed, sold, imported or exported by or for Cepheid
under the Cepheid License or any Cepheid Additional Licenses shall
be conspicuously marked, labeled and packaged with the following
label licenses (and advertised in a consistent manner) to the
extent reasonably practical:
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“The
purchase of this product includes a limited, non-transferable
license under U.S. Patents Nos. 6,787,338; 6,503,720 and 6,303,305,
and claims 9, 10, 11, 56, 76, 80 and 107 of U.S. Patent
No. 6,174,670, and corresponding claims in patents and patent
applications outside the United States, owned by the University of
Utah Research Foundation and licensed to Idaho Technology, Inc., to
use only this amount of product and only in an instrument marketed,
distributed, sold, leased or otherwise transferred using a Cepheid
trademark. No right is conveyed, expressly, by implication or
estoppel, under any other patent or patent claims owned by the
University of Utah Research Foundation or Idaho Technology, Inc.
Without limiting the foregoing, no right, title or license is
herein granted with respect to the uses that are proprietary to
Idaho Technology or the University of Utah Research Foundation of
fluorescent double stranded nucleic acid binding dyes ,
specifically including but not limited to SYBR® Green I,
LCGreen® I, or LCGreen® Plus.”
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“The
purchase of this instrument includes a limited, non-transferable
license under U.S. Patents Nos. 6,787,338; 6,503,720 and 6,303,305,
and claims 9, 10, 11, 56, 76, 80 and 107 of U.S. Patent
No. 6,174,670, and corresponding claims in patents and patent
applications outside the United States, owned by the University of
Utah Research Foundation and licensed to Idaho Technology, Inc. No
right is conveyed, expressly, by implication
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