EXHIBIT 10.14
LICENSE AGREEMENT
THIS LICENSE AGREEMENT, together with exhibits attached hereto
("Agreement"), effective as of October 15, 2002 (the "Effective Date"), is
entered into by and between THIRD WAVE TECHNOLOGIES, INC., organized under the
laws of Delaware and having its principal place of business at 000 X. Xxxx Xxxx,
Xxxxxxx, Xxxxxxxxx 00000 ("TWTI"), and ACLARA BIOSCIENCES, INC., organized under
the laws of Delaware and having its principal place of business at 0000 Xxxx
Xxxxxx, Xxxxxxxx Xxxx, Xxxxxxxxxx 00000 ("ACLA"). TWTI and ACLA may each be
referred to herein individually as a "Party" or, collectively, as "Parties."
RECITALS
WHEREAS, TWTI and ACLA entered into a Development and Commercialization
Agreement, dated October 24, 2001, which the Parties wish to terminate and
supersede, in its entirety (except as otherwise set forth below), by this
Agreement; and
WHEREAS, TWTI has technology and intellectual property for, among other
things, genetic analysis and life science research and testing, including test
kits, components, and other products and services based upon its proprietary
Invader(R) platform and/or Cleavase(R) enzymes; and
WHEREAS, ACLA has technology and intellectual property for, among other
things, genetic analysis and life science research and testing, including
products, services, and components based upon ACLA's eTag(TM) technology; and
WHEREAS, TWTI wishes to license to ACLA, and ACLA wishes to obtain from
TWTI, certain rights under TWTI intellectual property related to the Invader(R)
platform, InvaderCreator(TM) software and/or Cleavase(R) enzymes, to
commercialize certain assay products that perform multiplexed gene expression
using ACLA's eTag(TM) technology; and
WHEREAS, TWTI and ACLA are entering into a Supply Agreement of even
date herewith for the supply by TWTI to ACLA of Cleavase Enzyme (as defined
below) on the terms and conditions set forth therein and are entering into an
InvaderCreator(TM) Access Agreement of even date herewith for purposes of
providing ACLA with access to TWTI's InvaderCreator(TM) Software (as defined
below).
NOW, THEREFORE, in consideration of the promises and undertakings set
forth herein, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
Capitalized terms not otherwise defined herein will have the meaning
set forth below:
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1.1 "ACLARA COMPONENT" means an Aclara Precursor from a library that
***.
1.2 "ACLA ENTITIES" means ACLA, its Resellers, Value Added
Distributors, Manufacturing Distributors, and Affiliates of ACLA or any such
party.
1.3 "AFFILIATE" with respect to a party, means any business entity
controlling, controlled by, or under common control with such party, but only so
long as such control exists. For the purposes of this Section 1.3 and Sections
1.46 and 4.2(b) only, "control" means the possession, directly or indirectly, of
the power to direct the management or policies of an entity through ownership of
fifty percent (50%) or more of the voting securities of such entity (or, in the
case of an entity that is not a corporation, ownership of fifty percent (50%) or
more of the corresponding interest for the election of the entity's managing
authority); provided that, if local law in a country outside the United States
requires a minimum percentage of local ownership such that the maximum
percentage that may be owned by foreign interests is less than fifty percent
(50%), control will be established by direct or indirect beneficial ownership of
one hundred percent (100%) of the maximum ownership percentage that may, under
such local law, be owned by foreign interests.
1.4 "BRIDGING OLIGONUCLEOTIDE" shall have the meaning assigned in
Section 1.25 below.
1.5 "BUNDLED" shall mean that the specified items are not distributed
separately, but are promoted, priced, and distributed collectively as a Licensed
Product.
1.6 "CLEAVAGE ENZYME" means any enzyme that (A) recognizes the
structure formed by the hybridization of an Invader Probe and a Primary Probe to
their cognate Target sequence such that the Invader Probe overlaps, at its 3'
terminus by at least one nucleotide, the duplex formed by the hybridization of
the Primary Probe to the complementary region of the Target; (B) cleaves the
Non-Hybridizing Region from the Primary Probe when such structure exists; and
(C) has limited or no nucleic acid synthesis ability. It is acknowledged and
agreed that Cleavage Enzymes shall include enzymes having the three properties
described in (A), (B), and (C) of this Section 1.6 above, regardless of whether
or not the enzyme has other properties or uses, including causing cleavage under
different circumstances, or cleaves additional nucleic acid bases along with the
Non-Hybridizing Region. Cleavage Enzyme shall include those enzymes identified
on Exhibit 2.2 in the Supply Agreement.
1.7 "CLEAVASE ENZYME" shall mean any Cleavage Enzyme to the extent
actually (i) supplied by TWTI or its designee to ACLA under the Supply
Agreement; or (ii) manufactured by ACLA in accordance with Section 2.10 of the
Supply Agreement.
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1.8 "CONFIDENTIAL INFORMATION" means any and all information, including
without limitation Technology, that is disclosed by either Party to the other in
written or other similar form, by inspection of tangible objects, orally, or
otherwise in connection with this Agreement that if disclosed in tangible form
is marked "Confidential" or with other similar designation to indicate its
confidential or proprietary nature and that, if orally disclosed, is indicated
orally by the disclosing party at the time of such disclosure to be confidential
or proprietary and is confirmed as being confidential or proprietary by the
disclosing Party in a writing, designated as "Confidential" or with similar
designation, and delivered to the receiving Party within thirty (30) days of
such oral disclosure.
1.9 "CONTROL" means, with respect to an item of Technology or an
Intellectual Property Right, possession by the Party granting the applicable
license of the power and authority, whether arising by ownership, license, or
other authorization, to disclose and deliver the particular Technology or
Intellectual Property Right to the other Party, and to grant and authorize the
licenses, and sublicenses, as applicable, of the scope granted to such other
Party in this Agreement without giving rise to any of the following: (i) a
violation of the terms of any written agreement with any Third Party; (ii) a
violation or infringement of any Patent, copyright, trade secret, or other
Intellectual Property Right of any Third Party; (iii) the granting Party being
required to pay any royalty or other consideration to any Third Party that would
not have been required had a license not been provided under this Agreement;
(iv) a violation of any law, regulation, rule, code, order or other requirement
of any federal, state, foreign, local, or other government body or the need for
any additional permits, payments, authorizations, or approvals under any such
law, regulation, rule, code, order or requirement. Notwithstanding, the
provisions of clause (iii) of this Section 1.9, an item of Technology or an
Intellectual Property Right shall be deemed to be Controlled by a Party (for
purposes of this Section 1.9, the "Granting Party") for purposes of clause (iii)
above, if the other Party hereto (for purposes of this Section 1.9, the
"Licensed Party") agrees in writing to (A) to reimburse the Granting Party for
all amounts payable to a Third Party that would not have been required had a
license not been provided under this Agreement or pay such amounts directly to
such Third Party, at the election of the Granting Party, and (B) to reimburse
the Granting Party for fifty percent (50%) of any upfront, licensing, milestone,
milestone or other consideration payable to such Third Party, (but not including
(1) consideration payable as a result solely of the exercise of rights under
such item of Technology or Intellectual Property Rights by other than entities
acting by or under authority of the Licensed Party (i.e. running royalties) or
(2) amounts included in clause (A) above).
1.10 "DEVELOPMENT AND COMMERCIALIZATION AGREEMENT" means the certain
Development and Commercialization Agreement by and between TWTI and ACLA,
effective as of October 24, 2001 together with the separate letter agreement
related thereto between TWTI and ACLA, effective as of October 24, 2001.
1.11 "DIAGNOSTIC PROCEDURE" means ***.
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1.12 "ENABLED CUSTOMER AGREEMENT" means a written agreement between
ACLA and a Third Party (i) in which ACLA grants to such Third Party a sublicense
under Section 3.1(a) below to *** Probe Sets; (ii) in which ACLA grants to such
Third Party a sublicense under Section 3.1(b) below, but which sublicense is
limited ***; and (v) which otherwise contains terms and conditions at least as
protective of TWTI and the TWTI IP, and at least as restrictive of the Probe
Sets, Cleavase Enzyme, and Licensed Products, as the terms and conditions of
Articles and Sections 3.1, 3.2, 3.3, 3.12, 6.3, 7, 8.3, 10, and 11.10.
1.13 "ENABLED CUSTOMER" means a Third Party that (i) has entered into
an Enabled Customer Agreement with ACLA, (ii) ACLA has identified to TWTI in
writing as being an "Enabled Customer;" and (iii) has been appointed as such by
ACLA in accordance with this Agreement, in each case with respect to ***.
1.14 "END USER" shall mean any entity, including Technology Access
Partners and Affiliates, that purchases a Licensed Product, a Probe Set, or
Cleavase Enzyme in accordance with this Agreement for such entity's own use in
performing a Multiplexed Invader Application in the Gene Expression Field and
not for further distribution. An Enabled Customer shall be deemed to be an End
User except with respect to the design, manufacture and use of any Probe Set or
Cleavase Enzyme described in clauses (A) and (B) of Section 1.13 above.
1.15 "ETAG PROBE" means a Primary Probe in which the Non-Hybridizing
Region incorporates an Aclara Component in lieu of or attached to the one or
more nucleotides that may be included in the Non-Hybridizing Region.
1.16 "FLAP" shall have the meaning assigned in Section 1.25 below.
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1.17 "GAAP" means the then-current applicable Generally Accepted
Accounting Principles in the United States consistently applied as recognized or
accepted by the United States Securities and Exchange Commission and the
Financial Accounting Standards Board. As used herein, "GAAP" shall also include
cost accounting principles and procedures that are generally accepted in the
United States.
1.18 "GENE EXPRESSION FIELD" means ***.
1.19 "GENOTYPING FIELD" means ***.
1.20 "IMPROVEMENT PATENT CLAIMS" means any and all issued claims in
patents within Patents ("Issued Claims") to inventions made during the Term
claiming an invention which is an improvement, modification, enhancement,
adaptation, or new use, of any Cleavage Enzyme (covered by Issued Claims owned
or controlled by TWTI) or Invader Assay and is owned or Controlled by ACLA or
its affiliates during the Term, including without limitation Issued Claims to
inventions that are enhancements, adaptations, derivatives, and other
modifications of any Cleavase Enzyme or any Invader Reaction. Notwithstanding
the foregoing, Improvement Patent Claims shall exclude Issued Claims (a) that
claim a specific nucleotide sequence(1) or the use of a specific nucleotide
sequence, such as a particular Target or oligonucleotide probe, or the use of a
particular Target or an oligonucleotide probe; (b) in or to any specific
nucleotide sequences, whether a Target, oligonucleotide probe, or otherwise; or
(c) in or to the composition of matter or method of manufacture of any Aclara
Component or eTag Probe, or that requires the use of an Aclara Component, eTag
Probe, or such composition or method of manufacture; or (d) that claim any
method of use that does not describe (or depend from a claim that describes) a
Cleavage Enzyme (covered by Issued Claims owned or controlled by TWTI), Invader
Assay or use of a Cleavage Enzyme (covered by Issued Claims owned or controlled
by TWTI) or Invader Assay. For purposes of this definition, "Invader Assay"
means a biochemical test comprising the detection or quantification of a nucleic
acid that is dependent upon the coordinate action of at least an Invader Probe,
a Primary Probe, and a Cleavage Enzyme that cleaves an Overlap Region formed
when an Invader Probe and a Primary Probe hybridize to the nucleic acid.
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(1) As used in this Agreement, "nucleotide sequence" shall refer to a sequence
(of any length) of nucleotides in a nucleic acid whether synthesized or
naturally occurring, including nucleotide probes.
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1.21 "INTELLECTUAL PROPERTY RIGHTS" means any and all rights in, to, or
arising out of any (i) Patents; (ii) trade secrets or know how; (iii)
copyrights, copyright registrations, or any application therefor, in the U.S. or
any foreign country, or any other right corresponding thereto throughout the
world, including moral rights; or (iv) any other intellectual property or
proprietary right anywhere in the world.
1.22 "INVADERCREATOR ACCESS AGREEMENT" means that certain written
agreement titled "InvaderCreator Access Agreement" entered into between ACLA and
TWTI having an effective date of even date herewith.
1.23 "INVADERCREATOR SOFTWARE" shall have the meaning set forth in the
InvaderCreator Access Agreement.
1.24 "INVADER PROBE" means an oligonucleotide probe(2) comprising (A) a
region complementary to, and designed to hybridize to, the 3' portion of the
Target; and (B) an additional region (the "Overlap Region") located on the 3'
end of such oligonucleotide probe, which Overlap Region adjoins the foregoing
complementary region and comprises one or more nucleotides or other structural
moieties that overlaps the duplex formed by the hybridization of the Primary
Probe and its cognate Target by at least a single nucleotide base at the
boundary between the Non-Hybridizing Region and such duplex. The Overlap Region
may be complementary or non-complementary to the Target.
1.25 "INVADER REACTION" means the following reaction: (i) the
complementary portion of a Primary Probe hybridizes specifically to the 5'
portion of a Target sequence (i.e., hybridizes to a materially greater degree to
the Target sequence than to other nucleic acid sequences under the conditions of
such reaction) to form a duplex with such 5' portion ("Primary Duplex"), and the
Non-Hybridizing Region adjoined with the Primary Duplex does not hybridize to
the Target, wherein the Primary Probe cycles on and off of the Target under the
conditions of such reaction; (ii) the complementary portion of an Invader Probe
hybridizes specifically to the 3' portion of such Target sequence to form a
stable duplex (i.e., the melting temperature for the duplex is at least seven
(7) degrees centigrade above the reaction temperature) with such 3' portion
("Invader Duplex") such that the Invader Duplex is contiguous with the Primary
Duplex at the boundary between the Primary Duplex and the Non-Hybridizing
Region, and the Overlap Region adjoined with the Invader Duplex extends into the
Primary Duplex such that the Overlap Region is contiguous with at least one
nucleotide base pair of the Primary Duplex that is adjacent to such boundary;
and (iii) Cleavase Enzyme cleaves from the structure so formed the
Non-Hybridizing Region of the Primary Probe, including the Aclara Component
incorporated therein, together with one additional 3' nucleotide base from the
Primary Probe's complementary region (the "Flap"). Notwithstanding anything to
the contrary, Invader Reaction shall exclude any and all uses or applications in
which the Flap or other cleaved nucleic acid sequence is used as a Target,
Primary Probe, Invader Probe or otherwise in a cleavage reaction or the Flap is
further amplified or used to amplify any specific nucleotide sequence. Except
with respect to any Primary Probe as described in Section 1.35 below, Invader
Reaction shall exclude any reaction which (i) is
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(2) As used in this Agreement, "oligonucleotide probe" shall refer to any
synthesized or otherwise manufactured sequence (of any length) of nucleotides in
a nucleic acid, including DNA, RNA, PNA, modified or synthesized nucleotides,
universal bases, adducts, or the like, or combinations thereof.
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based upon or uses the SST Technology (including without limitation any reaction
components, methods, compositions) or (ii) employs any Bridging Oligonucleotide.
For purposes of this Section 1.25, "SST Technology" shall mean any and all
subject matter claimed in U.S. Patent Nos. 6,214,545, 6,210,880, and 6,194,149
together with any and all subject matter claimed in Patents based on such
patents or subject matter; and "Bridging Oligonucleotide" shall mean an
oligonucleotide that comprises two or more regions that are complementary to a
nucleotide sequence separated by at least one nucleotide or non-nucleotide
chemical linker that is not complementary to such nucleotide sequence.
1.26 "LICENSED PRODUCT" means a product to the extent designed and used
to perform a Multiplexed Invader Application, which product consists only of the
following: (A) eTag Probes and Invader Probes which are suitable for use with
each other for performing each Invader Reaction in such Multiplexed Invader
Application; (B) that quantity of Cleavase Enzyme as is reasonably necessary to
use the particular quantity of eTag Probes and Invader Probes used in the
product to perform such Multiplexed Invader Application; and (C) buffers, salts,
or other reagents (e.g. cofactors and controls, but excluding Cleavage Enzymes
not obtained pursuant to the Supply Agreement) reasonably necessary or useful to
perform the Multiplexed Invader Application. For clarity, Licensed Product shall
exclude components and sub-configurations of the product described in this
Section 1.26, and none of the foregoing components shall be considered to be a
component of a Licensed Product if used other than in the Invader Reactions that
occur during the performance of the Multiplexed Invader Application by a
Licensed Product. Also for clarity, Licensed Product shall exclude all uses and
applications in which any Target is detected or quantified other than by a
Multiplex Invader Application. No product that uses or incorporates any
component other than as described above, such as Cleavage Enzyme that is not
Cleavase Enzyme, shall be considered a Licensed Product.
1.27 "MANUFACTURING DISTRIBUTOR" means a Third Party that has entered
into a Manufacturing Distributor Agreement with Aclara, with respect to Probe
Sets manufactured by such Third Party and sold to a Technology Access Partner.
1.28 "MANUFACTURING DISTRIBUTOR AGREEMENT" means a written agreement
between ACLA and a Third Party (i) in which ACLA grants to such Third Party a
sublicense under Section 3.1(a) below ***; and (iv) which otherwise contains
terms and conditions at least as protective of TWTI and the TWTI IP, and at
least as restrictive of the Probe Sets, as the terms and conditions of Articles
and Sections 3.1, 3.2, 3.3, 3.6, 3.7, 3.12, 4.2(b), 4.2(c), 4.2(d), 4.2(e), 4.3,
5, 6.3, 7, 8.3, 10, and 11.10.
1.29 "MULTIPLEXED INVADER APPLICATION" means ***.
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1.30 "NET SALES" means the total amount invoiced on the distribution of
Licensed Products, Probe Sets, and Cleavase Enzyme by ACLA, a Reseller, or a
Manufacturing Distributor, as the case may be in accordance with this Agreement,
(each, a "Seller") directly to the applicable End User less the following all as
calculated in accordance with GAAP: (i) all trade, cash and quantity credits,
discounts, refunds or rebates; (ii) amounts for claims, allowances or credits
for returns; charge backs; and (iii) packaging, handling fees and prepaid
freight, sales taxes, duties and other governmental charges (including value
added tax), but excluding what is commonly known as income taxes; provided that
in the case of (i) and (ii), such amounts are allowed by the Seller to, and
actually taken by, such End User, and in the case of (iii), such amounts are
charged separately on the invoice and paid by such End User. For purposes of
sales through Resellers, End User under this Section 1.30 shall be deemed to
mean the first Third Party not Affiliated with ACLA or the Reseller that
purchases the Licensed Product, Probe Set, or Cleavase Enzyme from the Reseller
in a fully arms length transaction. Net Sales shall be deemed to accrue in the
calendar year in which the later of invoice or shipment to the End User occurs.
Net Sales shall also include (A) the fair market value of Licensed Products,
Probe Sets and Cleavase Enzymes used by ACLA or its Affiliates in generating
data on behalf of a Third Party, where the data provided to such Third Party
describes the results of a Multiplex Invader Application, and (B) amounts
invoiced to a Third Party on the sale or other transfer of data generated from
use of a Licensed Product, Probe Set or Cleavase Enzyme, where such data is
intended or actually sold or transferred to multiple Third Parties. For clarity
and subject to Section 4.2(c) below, Net Sales shall exclude reasonable amounts
invoiced to an End User for the design of Probe Sets for use by such End User as
part of a Licensed Product, but shall include amounts invoiced on the
distribution of such Probe Sets.
1.31 "NON-HYBRIDIZING REGION" shall have the meaning assigned in
Section 1.35 below.
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1.32 "OTHER CONSIDERATION" means upfront access or license fees,
milestone payments, royalty payments, and any other consideration, as
applicable, received by ACLA, its Affiliate, or Reseller, from a Technology
Access Partner, a Value Added Distributor, a Manufacturing Distributor, or an
Enabled Customer, in connection with the grant to or exercise by such parties of
sublicensed rights under Section 3.2 of this Agreement, as applicable ("Granted
Rights"); excluding only Net Sales. Other Consideration shall be deemed to
accrue when first received by ACLA, its Affiliate or Reseller, as applicable.
1.33 "OVERLAP REGION" shall have the meaning assigned in Section 1.24
above.
1.34 "PATENT" means any and all rights under any of the following,
whether existing now or in the future: (i) a United States, international or
foreign patent, utility model, design registration, certificate of invention,
patent of addition or substitution, or other governmental grant for the
protection of inventions or industrial designs anywhere in the world, including
any reissue, renewal, re-examination or extension thereof; and (ii) any
application for any of the foregoing, including any international, provisional,
divisional, continuation, continuation-in-part, or continued prosecution
application.
1.35 "PRIMARY PROBE" means an oligonucleotide probe comprising (A) a
region complementary to, and designed to hybridize to, the 5' portion of a
Target; and (B) a non-hybridizing region located on the 5' end of such
oligonucleotide probe (the "Non-Hybridizing Region"); which Non-Hybridizing
Region adjoins with the foregoing complementary region and incorporates one or
more nucleotides, and may incorporate other structural moieties including an
Aclara Component. For purposes of this Section 1.35, "complementary" requires
that the region of the oligonucleotide probe that is complementary to the Target
(such Target, the "Primary Target") be fully complementary to the nucleotide
sequence of the Primary Target, however such oligonucleotide probe may be
non-complementary to one or more other nucleotide sequences that are highly
homologous to the Primary Target (such other nucleotide sequences, "Other
Targets") also present in a sample such that the oligonucleotide probe may be
used to detect and or quantify both the Primary Target and the Other Target(s)
in the sample by means of an Invader Reaction. For the sake of clarity, it is
understood that the Primary Target for which a particular Primary Probe is
designed, may or may not be present in a particular sample.
1.36 "PROBE SET" means a pair of oligonucleotide probes, which pair
consists only of an eTag Probe and an Invader Probe necessary for the Invader
Reaction to detect or quantify a particular Target in the Gene Expression Field
and the Genotyping Field.
1.37 "RESELLER" means a Third Party that has entered into a Reseller
Agreement with ACLA with respect to (i) Probe Sets obtained directly from ACLA
or a Manufacturing Distributor and sold to a Technology Access Partner (ii) or
Cleavase Enzyme obtained directly from ACLA and sold to a Technology Access
Partner or (iii) Licensed Products obtained directly from ACLA and sold to End
Users.
1.38 "RESELLER AGREEMENT" means a written agreement between ACLA and a
Third Party (i) in which ACLA (A) ***.
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(iii) which otherwise contains terms and conditions at least as protective of
TWTI and the TWTI IP, and at least as restrictive of the Licensed Products,
Probe Sets and Cleavase Enzyme, as the terms and conditions of Articles and
Sections 3.1, 3.2, 3.3, 3.6, 3.7, 3.12, 4.2(b), 4.2(c), 4.2(d), 4.2(e), 4.3, 5,
6.3, 7, 8.3, 10, and 11.10. Notwithstanding anything to the contrary, for
purposes of sales through Resellers, End User under this Section 1.38 shall be
deemed to mean the first Third Party not Affiliated with ACLA or the Reseller
that purchases the Licensed Product, Probe Set, or Cleavase Enzyme from the
Reseller in a fully arms length transaction.
1.39 "SST TECHNOLOGY" shall have the meaning assigned in Section 1.25
above.
1.40 "SUPPLY AGREEMENT" means that certain written "Supply Agreement"
entered into by and between ACLA and TWTI, effective on even date herewith.
1.41 "TAP AGREEMENT" means a written agreement between ACLA and a Third
Party *** (iii) which otherwise contains terms and conditions at least as
protective of TWTI and the TWTI IP, and at least as restrictive of the Probe
Sets, Cleavase Enzyme, and Licensed Products, as the terms and conditions of
Sections 3.1, 3.2, 3.3, 3.12, 6.3, 7, 8.3, 10, and 11.10.
1.42 "TARGET" means (i) when used for purposes of or in connection with
the licenses under Section 3.1, any natural or synthetic nucleic acid that is in
the Gene Expression Field and is of a sufficient length to allow discrimination
of other non-homologous nucleic acids in a Multiplex Invader Application; and
(ii) when used for purposes of or in connection with the license under Section
3.5 only, any natural or synthetic nucleic acid that is in the Genotyping Field
and is of a sufficient length to allow discrimination of other non-homologous
deoxyribonucleic acids in a Multiplex Invader Application.
1.43 "TECHNOLOGY" means any and all technology and technical
information, including without limitation data, results, samples, inventions
(whether or not patented or patentable), knowledge, ideas, developments,
prototypes, invention disclosures, designs, processes, sequences, methods,
techniques, materials, instructions, recipes, formulas, compositions of matter,
chemistries, algorithms, trade secrets, know-how, research, modifications,
software,
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formulas, drawings, equipment, machines, protocols, configuration and process
information, specifications, models, works of authorship, improvements, and any
other technical subject matter.
1.44 "TECHNOLOGY ACCESS PARTNER" means a Third Party that has entered
into a TAP Agreement with ACLA.
1.45 "TERM" shall have the meaning assigned to it in Section 10.1
below.
1.46 "THIRD PARTY" means any party other than TWTI and ACLA. For
clarity, Third Party shall include Affiliates of each Party, unless the
Affiliate is 100% controlled (as defined in Section 1.3) by the applicable
Party.
1.47 "TRANSFER PRICE" shall have the meaning, with respect to Cleavase
Enzyme, as set forth in the Supply Agreement.
1.48 "TWTI IP" means any and all Patent claims to the extent Controlled
by TWTI during the Term and ***. A list of such Patents Controlled by TWTI as of
the Effective Date is attached hereto as Exhibit 1.48; it being understood that
the list is not intended to be exhaustive of all such Patents Controlled by TWTI
or licensed hereunder. For clarity, TWTI IP excludes ***. For purposes of this
Section 1.48, "primarily directed at practicing" ***.
1.49 "TWTI MARKS" means the trademarks, trade names and logos of TWTI
to be set forth in Exhibit 1.49 referencing this Section 1.49 and provided to
ACLA within ten (10) days of the Effective Date, as amended from time to time in
accordance with this Agreement. Invader(R) and Cleavase(R) are registered
trademarks of TWTI, but are printed in this Agreement without the registration
xxxx for convenience. Similarly, InvaderCreator is a trademark of TWTI, but is
printed in this Agreement without the TM xxxx for convenience.
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1.50 "VALID CLAIM" means (a) a claim of an issued and unexpired Patent,
which claim has not lapsed or been abandoned, has not been canceled or declared
invalid or unenforceable by an unreversed and unappealable decision or judgment
of a court or other appropriate body of competent jurisdiction, and has not been
admitted to be invalid or unenforceable through reissue or disclaimer; or (b) a
claim of a pending patent application, provided that such application has been
pending for a period not to exceed ten (10) years from the earliest date such
application takes priority.
1.51 "VALUE ADDED DISTRIBUTOR" means a Third Party that has entered
into a Value Added Distributor Agreement with ACLA, with respect to Probe Sets
manufactured by such Third Party and sold to a Enabled Customer.
1.52 "VALUE ADDED DISTRIBUTOR AGREEMENT" means a written agreement
between ACLA and a Third Party (i) in which ACLA grants to such Third Party a
sublicense under Section 3.1(a) below ***. and (iv) which otherwise contains
terms and conditions at least as protective of TWTI and the TWTI IP, and at
least as restrictive of the Probe Sets, as the terms and conditions of Articles
and Sections 3.1, 3.2, 3.3, 3.6, 3.7, 3.12, 4.2(b), 4.2(c), 4.2(d), 4.2(e), 4.3,
5, 6.3, 7, 8.3, 10, and 11.10.
ARTICLE 2
TERMINATION OF DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
2.1 TERMINATION. TWTI and ACLA hereby agree to terminate the
Development and Commercialization Agreement in its entirety, including, without
limitation, Section 19.5 thereof. Such termination shall be effective as of the
Effective Date of this Agreement; provided, however, that notwithstanding the
foregoing and anything to the contrary in this Section 2.1, the following
provisions of the Development and Commercialization Agreement shall remain in
effect: Articles 14, 15, and 17 and Sections 4.12 and 16.4.3. All other terms
and conditions of the Development and Commercialization Agreement are hereby
terminated and shall have no further force or effect. Such termination of the
Development and Commercialization Agreement shall be deemed to be termination
mutually agreed upon by and between TWTI and ACLA, and neither Party shall have
any responsibility or liability as a result of such termination. The Parties
hereby waive all rights to notice of termination as may be otherwise provided
under the Development and Commercialization Agreement or applicable laws. As of
the Effective Date of this Agreement, and except as otherwise expressly
surviving pursuant to this Section 2.1, all rights and licenses granted by TWTI
to ACLA under the Development and Commercialization Agreement shall terminate
and revert to TWTI, and all rights and licenses granted by ACLA to TWTI under
the Development and Commercialization Agreement shall terminate and revert to
ACLA.
12
ARTICLE 3
GRANTS OF RIGHTS
3.1 LICENSE GRANTS TO ACLA WITHIN THE GENE EXPRESSION FIELD.
(A) Manufacture of Probes. Subject to the terms and conditions
of this Agreement, TWTI hereby grants to ACLA a worldwide, non-exclusive,
royalty bearing license under the TWTI IP to manufacture, and have manufactured,
Probe Sets in the Gene Expression Field that are included in a Licensed Product
as set forth in Section 3.1(b) and used solely as part of a Licensed Product in
the Gene Expression Field for Multiplex Invader Applications in accordance with
this Agreement.
(I) Sublicenses. ACLA shall have no right to grant or
authorize sublicenses under this Section 3.1(a), except to the extent expressly
set forth in Sections 3.2(b), 3.2(c) and 3.2(d) below.
(II) Have Made Rights. ACLA shall have the right to
use contract manufacturers to manufacture Probe Sets under this Section 3.1(a),
provided that the contract manufacturer is subject to a written agreement with
ACLA that is at least as protective of TWTI and the TWTI IP, and at least as
restrictive of the Probe Sets, as the terms and conditions of Articles and
Sections 3.1, 3.6, 3.7, 3.12, 5.3, 5.4, 6.3, 7, 8.3, 10, and 11.10. All eTag
Probes and Invader Probes manufactured under the have made rights under this
Section 3.1(a) shall be provided only to ACLA for disposition and use in
accordance with this Agreement. No rights for contract manufacturers to use
Probe Sets are granted or implied.
(III) Other Restrictions. All sublicenses under this
Section 3.1 shall be only under that TWTI IP that is necessary to manufacture,
and have manufactured, the particular Probe Sets that the applicable sublicensee
manufactures. For clarity, Confidential Information of TWTI shall be disclosed
to sublicensees and contract manufacturers under this Section 3.1 only as
necessary to enable the sublicensee or contract manufacture, as applicable, to
manufacture the applicable Probe Sets. Any failure of a contract manufacturer or
sublicensee to comply with terms or conditions required by this Agreement shall
be deemed to be a breach of this Agreement by ACLA; provided that TWTI agrees
that it will not terminate this Agreement for such a breach if ACLA (i) within
sixty (60) days of becoming aware of such breach uses commercially reasonable
efforts to cure such breach within such period and (ii) if such breach has not
been cured within such sixty (60)-day period immediately terminates all rights
of the contract manufacturer or sublicensee, as applicable, pursuant to this
Agreement including requiring the sublicensee or contract manufacturer to return
to ACLA at that time, and discontinue all further use of, the TWTI Confidential
Information.
(B) Making Licensed Product. Subject to the terms and
conditions of this Agreement, TWTI hereby grants to ACLA a worldwide,
non-exclusive, royalty bearing license under the TWTI IP to make Licensed
Products in the Gene Expression Field solely by bundling together to form the
Licensed Product (i) Probe Sets manufactured by ACLA, or its contract
manufacturer, under Section 3.1(a); (ii) Cleavase Enzyme obtained or
manufactured by ACLA pursuant to the Supply Agreement; and (iii) buffers, salts
or other reagents (e.g. cofactors and controls, but excluding Cleavase Enzymes
not obtained pursuant to the Supply Agreement)
13
reasonably necessary or useful to perform the applicable Multiplexed Invader
Application for which the Licensed Product is designed. ACLA shall have no right
to grant or authorize sublicenses under this Section 3.1(b) except to the extent
expressly set forth in Sections 3.2(d) and 3.2(e) below. For clarity, no have
made rights are granted under this Section 3.1(b).
(C) Use of Licensed Product, Probe Sets, and Cleavase Enzyme.
Each Licensed Product under this Section 3.1 is and shall be licensed for use,
whether created or used by ACLA or otherwise, solely to perform the Multiplexed
Invader Application in the Gene Expression Field for which such Licensed Product
is designed. Similarly, each eTag Probe and Invader Probe under this Section
3.1, and all Cleavase Enzyme, is and shall be licensed for use, whether used by
ACLA or otherwise, solely as part of a Licensed Product to perform the
Multiplexed Invader Application in the Gene Expression Field for which the
Licensed Product is designed. All other uses are and shall be expressly
prohibited. ACLA shall have no right to grant or authorize sublicenses under
this Section 3.1(c) except to the extent expressly set forth in Sections 3.2(d)
and 3.2(e) below.
(D) Distribution of Licensed Product. Subject to the terms and
conditions of this Agreement, TWTI hereby grants to ACLA a worldwide,
non-exclusive, royalty bearing license under the TWTI IP, without the right to
grant or authorize sublicenses except as expressly set forth in Section 3.2(a)
below, to sell, and offer to sell, (directly or through a Reseller) to End Users
Licensed Product that are created by ACLA solely in accordance with Sections
3.1(a) and 3.1(b) and used by the End User solely in accordance with Section
3.1(c); provided that only complete Licensed Products, each Bundled with all of
its components at the time of purchase from ACLA, shall be distributed under
this Section 3.1(d). Without limiting the foregoing, each Licensed Product
distributed under this Section 3.1(d) shall conspicuously display a label
indicating that it is "FOR RESEARCH USE ONLY; NOT FOR USE IN DIAGNOSTIC
PROCEDURES. NOT FOR RESALE."
(E) Distribution of Probe Sets. Notwithstanding Section 3.1(d)
and subject to the terms and conditions of this Agreement, TWTI hereby grants to
ACLA a worldwide, non-exclusive, royalty bearing license under the TWTI IP to
(i) sell, and offer to sell, Probe Sets (directly or through a Reseller) to
Technology Access Partners; (ii) to sublicense Manufacturing Distributors to
sell, and offer to sell, Probe Sets directly to Technology Access Partners; and
(iii) to authorize Value Added Distributors to sell, and offer to sell, Probe
Sets directly to Enabled Customers. Without limiting the other terms of this
Agreement, all Probe Sets distributed pursuant to (A) Section 3.1(e)(i), (ii)
and (iii) shall conspicuously display a label indicating that it is "FOR
RESEARCH USE ONLY; NOT FOR USE IN DIAGNOSTIC PROCEDURES. NOT FOR RESALE."; (B)
Section 3.1(e)(i) and (ii) shall conspicuously display the additional label
indicating that it is "LICENSED FOR USE SOLELY IN ACCORDANCE WITH THE TERMS OF A
TAP AGREEMENT BETWEEN THE USER AND ACLARA BIOSCIENCES, INC.;" and (C) Section
3.1(e)(iii) shall conspicuously display the additional label indicating that it
is "LICENSED FOR USE SOLELY IN ACCORDANCE WITH THE TERMS OF AN ENABLED CUSTOMER
AGREEMENT BETWEEN THE USER AND ACLARA BIOSCIENCES, INC." ACLA shall have no
right to grant or authorize sublicenses under this Section 3.1(e) except as
expressly set forth in this Section 3.1(e) above.
14
(F) Distribution of Cleavase Enzyme. Notwithstanding Section
3.1(d) and subject to the terms and conditions of this Agreement, TWTI hereby
grants to ACLA a worldwide, non-exclusive, royalty bearing license under the
TWTI IP to sell, and offer to sell, Cleavase Enzyme solely (i) to Technology
Access Partners directly or through Resellers; and (ii) directly to those
Enabled Customers authorized in accordance with Section 3.2(d) below. Without
limiting the other terms of this Agreement, all Cleavase Enzyme distributed
pursuant to (A) Section 3.1(f)(i) and (ii) shall conspicuously display a label
indicating that it is "FOR RESEARCH USE ONLY; NOT FOR USE IN DIAGNOSTIC
PROCEDURES.", (B) Section 3.1(f)(i) shall conspicuously display the additional
label indicating that it is "LICENSED FOR USE SOLELY IN ACCORDANCE WITH THE
TERMS OF A TAP AGREEMENT BETWEEN THE USER AND ACLARA BIOSCIENCES, INC.;" and (C)
Section 3.1(f)(ii) shall conspicuously display the additional label indicating
that it is "LICENSED FOR USE SOLELY IN ACCORDANCE WITH THE TERMS OF AN ENABLED
CUSTOMER AGREEMENT BETWEEN THE USER AND ACLARA BIOSCIENCES, INC." This Section
3.1(f) shall not be construed to grant or imply any rights with respect to
Cleavase Enzyme other than the right to distribute expressly set forth in this
Section 3.1(f) above. ACLA shall have no right to grant or authorize sublicenses
under this Section 3.1(f) except as expressly set forth in this Section 3.1(f)
above.
3.2 LIMITED SUBLICENSE AND AUTHORIZATION RIGHTS OF ACLA IN THE GENE
EXPRESSION FIELD.
(A) Resellers. Subject to the terms and conditions of this
Agreement, ACLA may authorize Resellers to ***. ACLA shall disclose Confidential
Information of TWTI to Resellers only as necessary to enable the Reseller to
perform its rights under 3.2(a)(i) and (ii) above, and Resellers shall not
further disclose such Confidential Information. Distribution by Resellers shall
be solely in accordance with the restrictions on distribution set forth in
Sections 3.1(d), (e) and (f). Any failure of a Reseller to comply with terms or
conditions required by this Agreement shall be deemed to be a breach of this
Agreement by ACLA; provided that TWTI agrees that it will not terminate this
Agreement for such a breach if ACLA (A) within sixty (60) days of becoming aware
of such breach uses commercially reasonable efforts to cure such breach within
such period and (B) if such breach has not been cured within such sixty (60)-day
period immediately terminates all rights of the Reseller including requiring the
Reseller to return to ACLA at that time, and discontinue all further use of, the
TWTI Confidential Information, Licensed Products, Probe Sets, and Cleavase
Enzyme. For clarity, ACLA shall not make any sales of Licensed Product, Probe
Sets, or Cleavase Enzyme to or through the Reseller who is in breach of the
terms of this Agreement.
(B) Value Added Distributors. Subject to the terms and
conditions of this Agreement, ACLA shall have the right to grant limited
sublicense to Value Added Distributors to: ***.
15
Any failure of a Value Added Distributor to comply with terms or conditions
required by this Agreement shall be deemed to be a breach of this Agreement by
ACLA; provided that TWTI agrees that it will not terminate this Agreement for
such a breach if ACLA (A) within sixty (60) days of becoming aware of such
breach uses commercially reasonable efforts to cure such breach within such
period and (B) if such breach has not been cured within such sixty (60)-day
period immediately terminates all rights of the Value Added Distributor
including requiring the Value Added Distributor to return to ACLA at that time,
and discontinue all further use of, the TWTI Confidential Information. No Value
Added Distributor shall sell Probe Sets through any other party.
(C) Manufacturing Distributors. Subject to the terms and
conditions of this Agreement, ACLA shall have the right to grant limited
sublicenses to Manufacturing Distributors each to: (i) *** all in accordance
with this Agreement, provided that in each case the Manufacturing Distributor
has entered into a Manufacturing Distributor Agreement with ACLA. Any failure of
a Manufacturing Distributor to comply with terms or conditions required by this
Agreement shall be deemed to be a breach of this Agreement by ACLA; provided
that TWTI agrees that it will not terminate this Agreement for such a breach if
ACLA (A) within sixty (60) days of becoming aware of such breach uses
commercially reasonable efforts to cure such breach within such period and (B)
if such breach has not been cured within such sixty (60)-day period immediately
terminates all rights of the Manufacturing Distributor including requiring the
Manufacturing Distributor to return to ACLA at that time, and discontinue all
further use of, the TWTI Confidential Information. No Manufacturing Distributor
shall sell Probe Sets through any other party other than ACLA or Resellers.
(D) Enabled Customers. Subject to the terms and conditions of
this Agreement, ACLA shall have the right to grant limited sublicenses to
Enabled Customers each to: ***. For purposes of clarity, no rights with respect
to any Cleavase Enzyme or Probe Sets, or the use thereof, shall be deemed
granted or implied as a result of this Section 3.2(d) or the sale of Cleavase
Enzyme or Probe Sets to the Enabled Customer, except for the rights expressly
set forth in this Section 3.2(d) above. No party other than the Enabled Customer
itself shall exercise the Enabled Customer's rights. Any failure of a
16
Enabled Customer to comply with terms or conditions required by this Agreement
shall be deemed to be a breach of this Agreement by ACLA; provided that TWTI
agrees that it will not terminate this Agreement for such a breach if ACLA (A)
within sixty (60) days of becoming aware of such breach uses commercially
reasonable efforts to cure such breach within such period and (B) if such breach
has not been cured within such sixty (60)-day period immediately terminates all
rights of the Enabled Customer including requiring the Enabled Customer to
return to ACLA at that time, and discontinue all further use of, the TWTI
Confidential Information. Notwithstanding anything to the contrary, the total
number of Enabled Customers to which such sublicenses may be granted under this
Section 3.2(d) shall not exceed *** Enabled Customers; and commencing on ***, if
ACLA has appointed less than *** Enabled Customers as of such time, ACLA shall
have the right to grant additional sublicenses under this Section 3.2(d) to
Enabled Customers only after obtaining the written permission of TWTI with
respect to the particular Enabled Customer, which permission shall not be
unreasonably withheld if the total number of Enabled Customers that ACLA has
appointed at any time is less than ***. TWTI shall inform ACLA in writing
whether or not it will grant such permission (the "Permission Notice") no later
than twenty (20) days after TWTI receives written notice from ACLA requesting
such permission. Upon ACLA's request, TWTI shall provide a reasonable
explanation of a reason for withholding its consent. For the purposes of
determining the reasonableness of withholding such permission if ACLA has
appointed less than a total of *** Enabled Customers under this Section 3.2(d)
only, TWTI shall consider the following factors: (i) if the number of Enabled
Customers is more than *** of the total number of Third Party, non-Affiliate,
users of Licensed Products in the Gene Expression Field and (ii) if Other
Consideration from Enabled Customers and Value Added Distributors is more than
*** of ACLA's Net Sales from sales of Licensed Product, Probe Sets, and Cleavase
Enzyme hereunder. For clarity and without limitation, TWTI shall have the right
to withhold consent if the number of Enabled Customers, or Other Consideration,
exceed the foregoing limits. If TWTI withholds its consent with respect to an
Enabled Customer when the total number of Enabled Customers is less than ***,
the Parties shall discuss in good faith for a period not to exceed forty-five
(45) days after ACLA receives the Permission Notice TWTI's reasons for
withholding consent to the extent necessary to assess whether or not there may
be mutually acceptable terms and conditions under which ACLA may make such sales
to the particular Enabled Customer.
(E) Technology Access Partners. Subject to the terms and
conditions of this Agreement, ACLA shall have the right to grant limited
sublicenses to Technology Access Partners under Section 3.1(b) to ***. For
purposes of clarity, no rights with respect to any Cleavase Enzyme or Probe
Sets, or the use thereof, shall be deemed granted or implied as a result of this
Section 3.2(e), or the sale of Cleavase Enzyme or Probe Sets to the Technology
Access Partner,
17
except for the rights expressly set forth in this Section 3.2(e) above. No party
other than the Technology Access Partner itself shall exercise the Technology
Access Partner's rights.
3.3 UNAUTHORIZED SALES. ACLA, Manufacturing Distributors, Value Added
Distributors, and Resellers shall not, directly or indirectly, market, sell or
distribute Licensed Product, eTag Probes, Invader Probes, or Cleavase Enzyme
anywhere in the world except in accordance with this Agreement and the same
shall be used only as a Licensed Product to perform the Multiplexed Invader
Application in the Gene Expression Field. No Licensed Product, Cleavase Enzyme,
eTag Probe, or Invader Probe shall be provided to any Third Party, whether by
ACLA, a Value Added Distributor, a Manufacturing Distributor, a Reseller, or
otherwise, if ACLA knows, or has reason to know, that a Licensed Product,
Cleavase Enzyme, eTag Probe, or Invader Probe provided to such Third Party has
been promoted or sold for use, or used, other than to perform a Multiplex
Invader Application in the Gene Expression Field as set forth in this Article 3.
3.4 INVADERCREATOR SOFTWARE. Access to the InvaderCreator Software by
ACLA will be subject to, and in accordance with, the terms and conditions of the
InvaderCreator Access Agreement between TWTI and ACLA of even date herewith.
Access to the InvaderCreator Software by ACLA's contract manufacturers,
Manufacturing Distributors, Value Added Distributors and Enabled Customers will
be subject to, and in accordance with, the terms and conditions of the
InvaderCreator Access Agreement.
3.5 GENOTYPING RESEARCH RIGHTS.
(A) Manufacture of Probes. Subject to the terms and conditions
of this Agreement, TWTI hereby grants to ACLA a worldwide, non-exclusive,
license, with no right to grant or authorize sublicenses, under the TWTI IP to
manufacture Probe Sets in the Genotyping Field that are included in a Licensed
Product as set forth in Section 3.5(b) and used solely under Section 3.5(c) as
part of a Licensed Product in the Genotyping Field to perform Multiplex Invader
Applications in accordance with this Agreement. For clarity, no have made rights
are granted under this Section 3.5(a).
(B) Making Licensed Product. Subject to the terms and
conditions of this Agreement, TWTI hereby grants to ACLA a worldwide,
non-exclusive, license, with no right to grant or authorize sublicenses, under
the TWTI IP to create Licensed Products in the Genotyping Field ("Genotyping
Products") solely by bundling together to form the Genotyping Products (i) Probe
Sets manufactured by ACLA under Section 3.5(a); (ii) Cleavase Enzyme obtained or
manufactured by ACLA pursuant to the Supply Agreement; and (iii) buffers, salts,
or other reagents (e.g. cofactors and controls, but excluding Cleavage Enzymes
not obtained under the Supply Agreement) reasonably necessary or useful to
perform the applicable Multiplexed Invader Application for which the Genotyping
Product is designed. For clarity, no have made rights are granted under this
Section 3.5(b).
(C) Use of Genotyping Product, Probe Sets, and Cleavase
Enzyme. Each Genotyping Product under this Section 3.5 is and shall be licensed
for use solely by ACLA to perform the Multiplexed Invader Application in the
Genotyping Field for ACLA's own internal research and development purposes, but
not for any Diagnostic Procedure or any commercial
18
purposes (including, for example, to provide services on behalf of any Third
Party). Similarly, each eTag Probe and Invader Probe under this Section 3.5, and
all Cleavase Enzyme in the Genotyping Field, is and shall be licensed for use
solely by ACLA as part of a Genotyping Product to perform the Multiplexed
Invader Application in the Genotyping Field for ACLA's own internal research and
development purposes, but not for any Diagnostic Procedure or any commercial
purposes (including, for example, to provide services on behalf of any Third
Party). All other uses are and shall be expressly prohibited.
3.6 USE OF TWTI MARKS.
(A) Trademark License. TWTI hereby grants to ACLA a
non-exclusive, non-transferable, royalty free license to use the TWTI Marks
during the Term in connection with the marketing, promotion, and sale of
Licensed Products, Cleavase Enzyme, and Probe Sets that are distributed and used
solely in accordance with Sections 3.1 and 3.2 above. Additionally, ACLA will
have the right to sublicense Resellers, Manufacturing Distributors and Value
Added Distributors (each an "Authorized User") to use the TWTI Marks during the
Term in connection with their marketing, promotion, and sale of Licensed
Products, Cleavase Enzyme, and Probe Sets (as applicable) that are distributed
and used solely in accordance with Sections 3.1 and 3.2 above. All ownership and
goodwill arising out of the use of the TWTI Marks shall vest in and inure solely
to the benefit of TWTI. TWTI reserves all rights regarding its trademarks, trade
names, and logos not expressly granted to ACLA. ACLA agrees to, and cause the
Authorized Users to, conduct business related to the Licensed Products, Cleavase
Enzyme, and Probe Sets in a manner that reflects favorably at all times on the
products, goodwill, and reputation of TWTI.
(B) Guidelines for use of Marks. All representations of TWTI
Marks that ACLA or an Authorized User intends to use shall first be submitted to
TWTI for approval (which shall not be unreasonably withheld) of design, color,
and other details or shall be exact copies of those used by TWTI and shall in
any event comply with usage guidelines as established by TWTI from time to time.
Within thirty (30) days of the Effective Date, TWTI will deliver to ACLA the
initial version of such guidelines. ACLA and each Authorized User shall submit
representative promotional materials, packaging and product using any TWTI Xxxx
to TWTI for TWTI's review and comment prior to their first use and prior to any
subsequent change or addition to such promotional, packaging and product
materials. Notwithstanding the foregoing, until TWTI delivers the initial
guidelines to ACLA as required above, TWTI will cooperate with ACLA to expedite
the review of any materials provided pursuant to this Section 3.6(b) and provide
comment within five (5) days of receipt thereof. TWTI may change its trademarks,
trade names, and logos, and usage guidelines, to be used hereunder only upon
ninety (90) days prior written notice to ACLA, setting forth in such notice the
changes. Changes shall be limited to changes that are generally applicable to
other uses of the trademarks, trade names, and logos by TWTI and its licensees
thereof. From and after the end of such ninety (90) day period, as so designated
in the notice, any trademarks, trade names, and logos that are to be deleted
shall cease to be a TWTI Xxxx, any trademarks, trade names, and logos that are
to be added shall thereafter be deemed to be a TWTI Xxxx and changes to the
usage guidelines shall take effect. ACLA shall solely bear all costs and
expenses that result from a change requested by TWTI.
(C) Quality Control and Other Restrictions. To enable TWTI to
monitor the quality of the Licensed Products and Probe Sets in connection with
which its trademarks, trade
19
names, and logos are used, ACLA shall, and cause each Authorized User to,
provide to TWTI, as reasonably requested by TWTI from time to time, reasonable
quantities of the applicable Licensed Products and Probes Sets, without charge,
for such purposes. Without limiting the foregoing, all Licensed Products, Probe
Sets, and Cleavase Enzyme manufactured by or on behalf of ACLA under this
Agreement or under the Supply Agreement shall be of at least the quality of
products that TWTI sells under the TWTI Marks. In addition, ACLA shall maintain,
and cause the Authorized Users to, require and monitor, reasonable quality
control procedures consistent with industry standards for all such Licensed
Products, Cleavase Enzyme and Probe Sets.
(D) Recordation. In those countries where a license to use
trademarks, trade names, or logos must be recorded, TWTI shall have the right to
provide and record a separate license for such licenses to ACLA hereunder. ACLA
shall cooperate in the preparation and execution of such documents. Upon
termination of a license, ACLA shall cooperate in the cancellation of any such
licenses recorded or entered into in applicable countries.
(E) Xxxx Infringement. ACLA shall, and cause the Authorized
Users to, notify TWTI promptly upon learning of any actual, alleged, or
threatened infringement of, or of any unfair trade practices, trade dress
imitation, passing off of counterfeit goods, or similar offenses relating to,
the trademarks, trade names, or logos of TWTI.
3.7 CO-BRANDING. All Licensed Product, Probe Sets, and Cleavase Enzyme
distributed under this Agreement, whether by ACLA or otherwise, and all
packaging materials, labels and promotional materials used in connection
therewith, shall display the TWTI Marks as more fully described in this Article
3. The TWTI Marks shall be applied to such Licensed Product, Probe Sets, and
Cleavase Enzyme in addition to any of ACLA's own trademarks, trade names, and
logos that it applies. The trademarks, trade names, and logos of both Parties
shall be displayed equally legibly and equally prominently on all Licensed
Products, Probe Sets, and Cleavase Enzyme but nevertheless separated from the
other so that each appears to be a xxxx in its own right, distinct from the
other xxxx. Unless otherwise agreed, no Licensed Product, Probe Set, Cleavase
Enzyme, or such materials or labels, shall display the trademarks, trade names,
or logos of any other party.
3.8 UPDATE DISCUSSIONS. The Parties agree to hold bi-annual meetings
(in person, by phone or by video conference) of mutually agreed personnel for
the purpose of discussing opportunities of mutual interest.
3.9 GRANT BACK TO TWTI. Subject to the terms and conditions of this
Agreement, ACLA hereby grants to TWTI:
(A) ACLA IP. ***; and
20
(B) Necessary Claims ***.
(C) Definitions. For purposes of Section 3.9(b) the following
terms shall have the definitions set forth below:
(I) "TWTI Products" shall mean products, components,
and services, the making, using, selling, distributing, or importing, of which,
absent the license granted by ACLA to TWTI under Section 3.9(b) that would
infringe but for the license granted by ACLA under the patent claims under
Section 3.9(b).
(II) "TWTI Net Sales" shall mean the total amount
invoiced on the distribution of TWTI Products to the applicable end user less
the following all as calculated in accordance with GAAP: (i) all trade, cash and
quantity credits, discounts, refunds or rebates; (ii) amounts for claims,
allowances or credits for returns; charge backs; and (iii) packaging, handling
fees and prepaid freight, sales taxes, duties and other governmental charges
(including value added tax), but excluding what is commonly known as income
taxes; provided that in the case of (i) and (ii), such amounts are allowed and
actually taken and in the case of (iii), such amounts are charged separately on
the invoice and paid. For purposes of sales of TWTI Products through resellers,
end user shall be deemed to mean the first Third Party not Affiliated with TWTI
or the reseller that purchases the TWTI Products from the reseller in a fully
arms length transaction. TWTI Net Sales shall be deemed to accrue in the
calendar year in which the later of invoice or shipment to the end user occurs.
(III) "Multiplex Applications Field" shall mean ***.
(D) Stacking. The royalty rate set forth in Section 3.9(b)
shall be reduced for particular units of TWTI Product by an amount equal to ***
of any amount of royalties and other payments required to be paid by TWTI to
Non-Affiliate Third Parties for a license under the Patents of the Third Party
to make, have made, use, sell, have sold or import such units of TWTI Products;
provided, however, that any reduction in the royalty
21
rates set forth in Section 3.9(b) pursuant to this Section 3.9(d) shall be
limited to *** (i.e., the royalty payable to ACLA on TWTI Net Sales shall not be
less than ***). As used in this Section 3.9(d), royalties and other payments
shall not include cost sharing or reimbursement, service or consulting fees,
payments for purchases, non-cash consideration, amounts paid for equity or
securities, dividends, profit distributions, amounts paid for facilities or
equipment, or any other payment or consideration which is not expressly
identified in the written agreement between TWTI and the applicable Third Party
as a payment for a license under the Third Party's Patents to make, have made,
use, sell, offer to sell, or import the applicable TWTI Product.
(E) Favorable Terms. If, during the period when TWTI is
obligated to pay royalties to ACLA under Section 3.9(b) with respect to TWTI Net
Sales (the "TWTI Royalty Period"), ACLA enters into a written agreement with any
Third Party, other than an Affiliate of ACLA, in which ACLA grants a license to
such Third Party, under those patent claims under which ACLA granted to TWTI a
license under Section 3.9(b), to make, use, and sell products, components or
services under financial terms, considered as a whole and taking into account
the non-cash consideration received by ACLA, that are substantially more
favorable than those provided to TWTI in Section 3.9(b) and provided that the
rights granted by ACLA are materially the same as set forth in Section 3.9(b),
then TWTI shall have the right to obtain such more favorable financial terms and
conditions under Section 3.9(b) during the TWTI Royalty Period to the extent and
for so long as those more favorable terms and conditions are made available to
such Third Party. Notwithstanding the foregoing, this Section 3.9(e) shall not
apply in connection with any litigation settlement, transfer or sale of all or
substantially all of ACLA's business or assets related to this Agreement,
whether by way of merger, acquisition of stock or assets, operation of the law,
or otherwise and shall not apply in connection with any agreement in which ACLA
grants exclusivity. No rebates, credits, or refunds shall be payable or provided
by ACLA as a result of this Section 3.9(e).
(F) No Disclosure Requirement. It is acknowledged and agreed
that nothing in this Agreement is intended to require either Party to disclose
Technology that is Confidential Information to the other Party, provided that if
such Technology is disclosed it will be included in the scope of the applicable
license as expressly set forth herein.
(G) Termination. During the TWTI Royalty Period, ACLA shall
have the right to terminate the licenses granted to TWTI in this Section 3.9
upon final determination, in accordance with Section 11.8(c) below, of a
material breach by TWTI of a material term of such license. It is understood
that upon expiration of the TWTI Royalty Period, the licenses granted in this
Section 3.9 shall become irrevocable.
3.10 CHANGES IN TWTI IP. ***.
22
3.11 ADDITIONAL DISCUSSIONS. From time to time ACLA and TWTI agree to
discuss the possibility of cooperating with each other with respect to the
combination of ACLA's proprietary eTag technology and TWTI's proprietary Invader
technology for certain commercial applications including for applications in the
Genotyping Field and for Diagnostic Procedures. Notwithstanding the foregoing,
neither Party shall have any liability arising out of or with respect to this
Section 3.11.
3.12 NO OTHER RIGHTS. Except for the rights expressly granted under
this Agreement, no right, title, or interest of any nature whatsoever is granted
whether by implication, estoppel, reliance, or otherwise, by any Party to any
other Party or any Affiliate of either. For clarity, nothing herein shall be
construed as TWTI granting, or TWTI authorizing the grant of, a right to use
Licensed Product, Cleavase Enzyme, or Probe Sets, beyond the rights to use set
forth in Sections 3.1(c) and 3.5(c). All rights and licenses granted to ACLA in
Sections 3.1 and 3.2 are non-transferable, except in accordance with Section
11.2. All sublicenses pursuant to Section 3.1 and 3.2 shall be non-transferable,
without the right to grant or authorize sublicenses; provided that ACLA may
authorize a sublicensee to transfer in its entirety a sublicense authorized by
this Agreement to an entity that during the Term becomes a successor in interest
to the sublicensee by way of merger, consolidation or other business
reorganization, the sale of stock, or the transfer of all or substantially all
of the business and assets of such sublicensee. ACLA agrees that it will not
exercise the rights granted under this Article 3, or engage in or authorize any
activities, to effectively grant sublicenses beyond those expressly authorized
in Section 3.2. Additionally, any sale or other distribution of Cleavase Enzyme,
Probe Set, or other component that is used to provide or perform any assay or
use that is subject to TWTI's Intellectual Property Rights, and any such use of
Cleavase Enzyme, Probe Set, or component, under the licenses granted to ACLA,
other than in accordance with this Article 3, shall be deemed to be unlicensed
and is prohibited by this Section 3.12. ALL RIGHTS WITH RESPECT TO TECHNOLOGY OR
INTELLECTUAL PROPERTY RIGHTS THAT ARE NOT SPECIFICALLY GRANTED HEREIN ARE
RESERVED TO THE OWNER OF SUCH TECHNOLOGY OR INTELLECTUAL PROPERTY RIGHTS.
ARTICLE 4
CONSIDERATION
4.1 INITIAL CONSIDERATION.
(A) Upfront Fee. ACLA shall pay to TWTI *** within five (5)
business days after the Effective Date. Payment of such amount shall be
non-refundable and non-creditable.
(B) Aclara Release. ACLA, for itself and for its successors,
assigns, subsidiaries, parents, and other Affiliates hereby unconditionally,
absolutely and completely releases TWTI, including TWTI's parents, subsidiaries
and other Affiliates, and the respective officers, directors, agents, and
employees of each, (each a "TWTI Released Party") from and against any and all
liability, damages, claims, actions, demands, responsibility, and causes of
actions (for purposes of this Section 4.1(b), "Claims") with respect to or
arising out of the
23
Development and Commercialization Agreement or the Parties' relationship with
each other thereunder, which ACLA ever had or may now have against TWTI. ACLA
waives any and all such Claims and its rights under California Civil Code
Section 1542 with respect to any such Claims, known or unknown. Notwithstanding
the foregoing, ACLA does not release or waive any Claims that ACLA ever had, may
now have, or which arise in the future under any surviving Section of the
Development and Commercialization Agreement as set forth in Article 2 above. For
clarity, however, no breach of this Agreement by TWTI shall give rise to Claims
determined based upon the Development and Commercialization Agreement.
(C) TWTI Release. TWTI, for itself and for its successors,
assigns, subsidiaries, parents, and other Affiliates hereby unconditionally,
absolutely and completely releases ACLA, including ACLA's parents, subsidiaries
and other Affiliates, and the respective officers, directors, agents, and
employees of each, (each an "ACLA Released Party") from and against any and all
liability, damages, claims, actions, demands, responsibility, and causes of
actions (for purposes of this Section 4.1(c) "Claims") with respect to or
arising out of the Development and Commercialization Agreement or the Parties'
relationship with each other thereunder, which TWTI ever had or may now have
against TWTI. TWTI waives any and all such Claims and its rights under
California Civil Code Section 1542 with respect to any such Claims, known or
unknown. Notwithstanding the foregoing, TWTI does not release or waive any
Claims that TWTI ever had, may now have, or which arise in the future under any
surviving Section of the Development and Commercialization Agreement as set
forth in Article 2 above. For clarity, however, no breach of this Agreement by
ACLA shall give rise to Claims determined based upon the Development and
Commercialization Agreement.
4.2 ROYALTIES.
(A) Annual Fixed Royalties. ACLA shall pay to TWTI an annual
fixed royalty in each calendar year of the three (3) calendar years beginning in
calendar year 2003 and continuing through calendar year 2005, as set forth in
this Section 4.2(a) below. ACLA shall make each payment to TWTI no later than by
January 15 of the applicable calendar year.
------------------------------------------- --------------------------------------
Calendar Year Annual Fixed Royalty
------------------------------------------- --------------------------------------
2002 No Royalty Due
------------------------------------------- --------------------------------------
2003 *** fixed royalty
------------------------------------------- --------------------------------------
2004 *** fixed royalty
------------------------------------------- --------------------------------------
2005 *** fixed royalty
------------------------------------------- --------------------------------------
24
(B) Royalties on Net Sales to End Users. Subject to Sections
4.4 and 6.4 below, ACLA shall pay to TWTI as royalties the following percentages
of Net Sales during the applicable calendar year beginning with calendar year
2006 and continuing during the remainder of the Term, as set forth in this
Section 4.2(b) below:
------------------------------------------- --------------------------------------
Calendar Year Royalty Rate
------------------------------------------- --------------------------------------
2006 and 2007 ***
------------------------------------------- --------------------------------------
2008 and 2009 ***
------------------------------------------- --------------------------------------
2010 and thereafter ***
------------------------------------------- --------------------------------------
For clarity, the Parties acknowledge that the royalties in this Agreement have
been established for the convenience of the Parties based upon the assumption
that the identified royalties will be paid on Licensed Product sold in all
countries of the world, whether or not a license under the TWTI IP is required
in the particular country in which the Licensed Product is manufactured, sold,
or otherwise commercialized. Accordingly, a royalty shall be paid by ACLA on all
Licensed Products in all countries whether or not a license is required in the
particular country. Notwithstanding anything to the contrary, in the event that
ACLA undergoes a change of control in any calendar year prior to January, 1
2010, the royalty rate on Net Sales under this Section 4.2(b) will be adjusted
to be *** effective as of the date of such change of control, and will remain
*** during the remainder of the Term; provided, however, that the effective date
of the royalty rate adjustment shall not be earlier than January 1, 2006. For
purposes of illustration, ***. For purposes of this Section 4.2(b), the term
"change of control" means any transaction or series of related transactions that
would occasion: (i) any share exchange, re-capitalization, business combination,
consolidation, merger or other transaction or series of transactions resulting
in the exchange of the outstanding shares of ACLA unless the stockholders of
ACLA that exist immediately prior to the closing date of such transaction (or
series of related transactions) hold, after the closing date, more than fifty
percent (50%) of the voting equity of the surviving entity in such transaction
computed on a fully diluted basis, (ii) a sale, lease, or other transfer of all
or substantially all of the assets or stock of ACLA; (iii) any tender offer or
exchange offer for fifty percent (50%) or more of the outstanding voting
securities of ACLA or the filing of a registration statement under the United
States Securities Act of 1933 in connection therewith; or (iv) any person or
group acting in concert to control ACLA (as control is defined in Section 1.3 of
this Agreement) having acquired beneficial ownership or the right to acquire
beneficial ownership of fifty percent (50%) or more of the outstanding voting
securities of ACLA. As used in this Section 4.2(b), "person" and "group" shall
have the meanings given to such terms when used in Sections 13(d) and 14(d) of
the United States Securities Exchange Act of 1934.
(C) Bundling. No Licensed Product shall be bundled and priced
with any other product, component or service; likewise, no Probe Set or Cleavase
Enzyme shall be bundled and priced with any other product, component or service
other than as part of a Licensed Product, except in both situations, Probe Sets,
Cleavase Enzyme or Licensed Products may be bundled (but not priced) with other
products, components and/or services, provided that such
25
Probe Sets, Cleavase Enzyme and Licensed Products are priced separately in
accordance with the principles set forth in Section 4.2(e) below.
(D) Royalty on all Components. For avoidance of doubt, Net
Sales shall include the Net Sales from the distribution of all items distributed
as part of a Licensed Product or Probe Set, including Cleavase Enzyme. ACLA
acknowledges and agrees that TWTI's compensation for such Cleavase Enzyme under
the Supply Agreement shall include both the Transfer Price for Cleavase Enzyme
under the Supply Agreement and a royalty under Section 4.2 on Net Sales from the
sale of Cleavase Enzyme, whether alone or as part of a Licensed Product. It is
agreed that the Transfer Price alone, whether set now or in the future, shall
not be considered complete compensation to TWTI for Cleavase Enzyme.
(E) Conflicts of Interest. In a transaction, or series of
separate transactions, involving the provision of License Products, Cleavase
Enzyme, Probes Sets, or data describing the results of a Multiplexed Invader
Application, and any other products, services, or non-cash consideration, to an
entity (or affiliated entities) by any combination of ACLA Entities, payments
received by any of the ACLA Entities as a result of such transaction(s) shall
not be shifted, allocated, or weighted among such products (including License
Products, Probe Sets, and Cleavase Enzyme), data, services, and non-cash
consideration in any manner so as to reduce or disadvantage the Net Sales from
the sale of License Products, Cleavase Enzymes, Probe Sets, Multiplexed Invader
Application data. In the event of any failure to comply with this Section
4.2(e), or in the event that the Net Sales from the sale of a particular License
Product, Cleavase Enzyme, Probe Set, or data is below the fair market value for
such License Product, Cleavase Enzyme, Probe Set, or data, as applicable, then
the Net Sales in the suspect transactions shall be deemed to be such fair market
value for purposes of calculating payments owed to TWTI.
4.3 SHARE OF OTHER CONSIDERATION. Subject to Section 6.4 ACLA shall pay
TWTI *** of any and all Other Consideration received during each such calendar
year of the Term; provided, however, that with respect to Other Consideration
received prior to January 1, 2006, ACLA shall pay to TWTI *** of such Other
Consideration allocated to the period after January 1, 2006 as set forth in this
Section 4.3. In the event that the Other Consideration is not in the form of
U.S. dollars, ACLA shall pay the fair market value of the Other Consideration to
TWTI. With respect to Other Consideration received prior to January 1, 2006, the
amount of such Other Consideration that shall be allocated to the period after
January 1, 2006 shall be equal to: the total amount of Other Consideration
received prior to January 1, 2006 multiplied by (1-X/Y), where (i) X is equal to
the duration of time for which the applicable Manufacturing Distributor, Value
Added Distributor, Enabled Customer, or Technology Access Partner is authorized
to exercise rights pursuant to this Agreement prior to January 1, 2006 in
connection with such Other Consideration; and (ii) Y is equal to the total
duration of time for which such party is authorized to exercise rights pursuant
to this Agreement. For purposes of the foregoing, Other Consideration received
in any transaction or a series of transactions with the same Third Party shall
be aggregated and allocated in accordance with the foregoing, notwithstanding
any contrary allocation in agreements between ACLA and the applicable party.
4.4 ROYALTY STACKING. The royalty rates set forth in Section 4.2(b)
shall be reduced for particular units of Licensed Product by an amount equal to
*** of any amount of royalties
26
and other payments required to be paid by ACLA to Non-Affiliate Third Parties
for a license under the Patents of the Third Party to make, have made, use,
sell, have sold or import such units of Licensed Products in the Gene Expression
Field; provided, however, that any reduction in the royalty rates set forth in
Section 4.2(b) pursuant to this Section 4.4 shall be limited such that (i) the
royalty rate in calendar year 2006 and/or calendar year 2007 will not be reduced
by more than *** (i.e., the royalty payable to TWTI on Net Sales shall not be
less than ***), (ii) the royalty rate in calendar year 2008 and/or calendar year
2009 will not be reduced by more than *** (i.e., the royalty payable to TWTI on
Net Sales shall not be less than ***), and (iii) the royalty rate in calendar
year 2010 and any calendar year thereafter will not be reduced by more than ***
(i.e., the royalty payable to TWTI on Net Sales shall not be less than ***). As
used in this Section 4.4, royalties and other payments shall not include cost
sharing or reimbursement, service or consulting fees, payments for purchases,
non-cash consideration, amounts paid for equity or securities, dividends, profit
distributions, amounts paid for facilities or equipment, or any other payment or
consideration which is not expressly identified in the written agreement between
ACLA and the applicable Third Party as a payment for a license under the Third
Party's Patents to make, have made, use, sell, offer to sell, or import the
applicable Licensed Product.
4.5 MOST-FAVORED FEE TERMS. If, during the Term, TWTI enters into a
written agreement with any Third Party, other than an Affiliate of TWTI, in
which TWTI grants a license to such Third Party, under the TWTI IP, to make,
use, and sell products in the Gene Expression Field for multiplex applications
(i.e., to analyze simultaneously within the same reaction container four (4) or
more RNAs in the same sample) under financial terms, considered as a whole and
taking into account the non-cash consideration received by TWTI, that are
substantially more favorable than those provided to ACLA in this Agreement and
provided that the rights granted by TWTI are materially the same as set forth in
this Agreement, then ACLA shall have the right to obtain such more favorable
financial terms and conditions under this Agreement during the Term to the
extent and for so long as those more favorable terms and conditions are made
available to such Third Party. Notwithstanding the foregoing, this Section 4.5
shall not apply in connection with any litigation settlement, transfer or sale
of all or substantially all of TWTI's business or assets related to this
Agreement, whether by way of merger, acquisition of stock or assets, operation
of the law, or otherwise and shall not apply in connection with any agreement in
which TWTI grants exclusivity. No rebates, credits, or refunds shall be payable
or provided by TWTI as a result of this Section 4.5.
4.6 TRANSFER PRICE RECONCILIATION. ACLA shall pay to TWTI a
Reconciliation Amount with respect to quantities of Cleavase Enzyme (i) provided
to Enabled Customers and (ii) used by ACLA, except for quantities of Cleavase
Enzyme used by ACLA for activities described in Section 1.30 clause (A) and any
activities for the development of Licensed Products, Probe Sets or Cleavase
Enzymes hereunder. For purposes of this Section 4.6, "Reconciliation Amount"
shall be equal to *** the Transfer Price for such Cleavase Enzyme. ACLA shall
not distribute Cleavase Enzyme to an Enabled Customer, or use Cleavase Enzyme
for the activities described in clause (ii) above except to the extent that ACLA
pays the Reconciliation Amount to TWTI in accordance with this Agreement. The
Reconciliation Amount payable under this Section 4.6 shall be deemed to accrue
in the calendar quarter in which the Cleavase Enzyme is distributed to the
Enabled Customer or so used by ACLA, as applicable. Notwithstanding the
foregoing, no Reconciliation Amount shall be due with respect to quantities of
Cleavase Enzyme manufactured by or under authority of ACLA pursuant to Section
2.10 of the Supply Agreement.
27
ARTICLE 5
PAYMENT PROVISIONS
5.1 REPORTS AND PAYMENTS. ACLA shall make written reports and
payments to TWTI within sixty (60) days after the close of each calendar
quarter. Such reports shall show for such calendar quarter, as applicable and
broken down on a region by region (i.e., United States, Europe, Asia, and Rest
of the World) basis: (i) Net Sales and Other Consideration; (ii) royalties due
on such Net Sales; (iii) fee sharing of Other Consideration as required pursuant
to Article 4; (iv) the quantities and type of Cleavase Enzyme provided to
Enabled Customers; (v) the quantities and type of Cleavase Enzyme used by ACLA
for the activities for which the Reconciliation Amount is due under Section
4.6(ii) above; and (vi) the amounts that have been excluded from Net Sales as a
result of Section 6.4. With respect to Enabled Customers that are also End
Users, ACLA shall provide documentation demonstrating to TWTI amounts to be
included in Net Sales, otherwise amounts received from Enabled Customers shall
be deemed Other Consideration. Concurrently with providing each such report,
ACLA shall pay TWTI all amounts accruing during the period covered by such
report. The Parties hereby acknowledge and agree that all reports, and all
information in such reports, provided by ACLA pursuant to this Section 5.1 are
Confidential Information of ACLA.
5.2 MODE OF PAYMENT. All payments made pursuant to this
Agreement shall be made by check or direct wire transfer of United States
Dollars in immediately available funds in the requisite amount to such bank
account as TWTI may from time to time designate by written notice to ACLA;
provided that all payments above One Million United States Dollars (U.S.
$1,000,000) shall be made by direct wire transfer. Payments will be without
reduction for any taxes (such as, without limitation, any withholding and other
taxes imposed on the payee), fees or charges, to the extent applicable. In the
event that sales are made or fees received in currency other than United States
Dollars, payments by ACLA shall be calculated based on currency exchange rates
for the last calendar quarter for which remittance is made. For each calendar
quarter, such exchange rate will equal the arithmetic average of the daily
exchange rates (obtained as described below) during the calendar quarter for
purchase of United States Dollars by sale of such non-United States Dollar
currency; each daily exchange rate will be obtained from the Reuters Daily Rate
Report or The Wall Street Journal, Eastern U.S. Edition, or, if not so
available, as otherwise agreed by the Parties.
5.3 RECORDS. ACLA shall keep, and shall cause its Resellers,
Value Added Distributors, and Manufacturing Distributors to keep, complete, true
and accurate books of account and records sufficient to determine and establish
the amounts payable under this Agreement, including without limitation to
determine and establish the quantities and types of Cleavase Enzyme distributed
to Enabled Customers or used by ACLA, and compliance with the other terms and
conditions of this Agreement, including Sections 4.2 and 4.3 above. Such books
and records shall be kept reasonably accessible for three (3) years following
the end of the calendar quarter to which they pertain and shall be made
available for inspection throughout such three (3) year period by an independent
third party auditor selected by TWTI for such purposes in accordance with
Section 5.4 below.
28
5.4 AUDITS.
(A) AUDIT RIGHTS; PROCEDURE. Upon the written request of
either Party (for purposes of this Section 5.4, the "Requesting Party"), and not
more than once in each calendar year, the other Party (or in the case of ACLA,
each of the ACLA Entities) (for purposes of this Section 5.4, the "Other Party")
shall permit an independent certified public accounting firm (or other auditor
in the case of audits for compliance with license restrictions) of an
internationally recognized standing selected by the Requesting Party, and
reasonably acceptable to the Other Party, at the Requesting Party's expense, to
have access during normal business hours, and upon reasonable prior written
notice, only to such of the records of the Other Party as may be reasonably
necessary to, as applicable, verify the accuracy of any financial reports to the
Requesting Party with respect to the preceding three (3) years, to confirm
compliance with license restrictions, or verify that the Requesting Party is
receiving the most favorable terms as provided under Section 3.9(e) or 4.5
above, as applicable. For clarity, the auditor appointed by TWTI shall have the
right to inspect Enabled Customer Agreements, Technology Access Partner
Agreements, Reseller Agreements, Manufacturing Distributor Agreements, and Value
Added Distributor Agreements to confirm compliance with license restrictions and
to evaluate Other Consideration. Additionally, for clarity, the auditor
appointed by either Requesting Party shall have the right to inspect all
agreements relevant to confirm compliance with Section 3.9(e) or 4.5, as
applicable, between the Other Party and non-Affiliate Third Parties. The
accounting firm or other auditor, as applicable, will disclose to the Requesting
Party whether the reports are correct or incorrect and, if incorrect, the amount
by which the reports reveal any underpayment to the Requesting Party and the
reason for such underpayment or whether the license restrictions have been
complied with and, if the auditor believes there may be a non-compliance, all
information relevant to the non-compliance. If the accounting firm or other
auditor, believes the Other Party has not complied with Section 3.9(e) or
4.5, as applicable, the auditor will so notify the Other Party in writing and
the auditor will discuss the matter with the Other Party in good faith for sixty
(60) days after receipt of such notice. If the auditor remains convinced that
the Other Party has not complied with Section 3.9(e) or 4.5, as applicable,
after such discussion, and the Other Party has not agreed to take action which
the auditor agrees would remedy such noncompliance, then the auditor shall
disclose to the Requesting Party the financial terms of the agreements between
the Other Party and the non-Affiliate Third Parties which are material to such
noncompliance. The Parties shall resolve any dispute in accordance with Section
5.4(d) below. Any and all information disclosed to the Requesting Party under
this Section 5.4(a) shall be deemed Confidential Information of the Party that
was being audited and no other information will be disclosed to the Requesting
Party.
(B) ADDITIONAL PAYMENTS; COST REIMBURSEMENT. If such
accounting firm concludes that additional payments were owed to the Requesting
Party by the Other Party during such period, then the Other Party shall pay the
additional payments, with interest from the date originally due at an amount
equal to the lesser of the prime rate plus two percent (2%), as published in The
Wall Street Journal, Eastern U.S. Edition, on the last business day preceding
such date, or the maximum amount permitted by applicable law, within thirty (30)
days after the date the Requesting Party delivers to the Other Party such
accounting firm's written report unless the additional payment is disputed by
the Other Party pursuant to Section 5.4(d) below. If the amount of the
underpayment for such period of at least one (1) year is greater than ten
percent (10%) of the total amount owed for that year and greater than Ten
Thousand United States
29
Dollars ($10,000), then the Other Party shall, in addition, reimburse the
Requesting Party for its reasonable costs related to such audit.
(C) CONFIDENTIALITY. The Requesting Party shall treat all
information subject to review under this Section 5.4 as Confidential Information
of the Other Party and in accordance with the confidentiality provisions of
Article 7, and will cause its accounting firm to enter into a confidentiality
agreement consistent with Article 7, obligating such firm to retain all such
financial information in confidence pursuant to such confidentiality agreement.
(D) AUDIT DISPUTES. If the Other Party in good faith disputes
the conclusion of the accounting firm under Section 5.4(a) above that the Other
Party owes additional royalties or other payments, or any specific aspect of the
conclusion, then the Other Party will inform the Requesting Party by written
notice within thirty (30) days of receiving a copy of the audit containing such
conclusion, specifying in detail the reasons for disputing such conclusion.
Likewise, if the Other Party in good faith disputes the conclusion under Section
5.4(a) above that any particular agreement provides a non-Affiliate Third Party
more favorable financial terms, or any specific aspect of the conclusion, then
the Other Party will inform the Requesting Party by written notice within thirty
(30) days of receiving a copy, from the Requesting Party, of the audit
containing such conclusion, specifying in detail the reasons for disputing such
conclusion. In either such case, the Parties shall promptly thereafter meet and
negotiate in good faith a resolution to such dispute. In the event that such
Parties are unable to resolve such dispute within sixty (60) days after such
notice, the matter will be resolved in accordance with Section 11.8 regarding
dispute resolution.
5.5 LATE PAYMENT. Any payments or portions thereof due hereunder which
are not paid when due shall bear interest equal to the lesser of the prime rate
as reported by the Chase Manhattan Bank, New York, New York, on the date such
payment is due, plus an additional two percent (2%), or the maximum rate
permitted by law, calculated on the number of days such payment is delinquent.
This Section 5.5 shall in no way limit any other remedies available to either
Party.
ARTICLE 6
INTELLECTUAL PROPERTY
6.1 OWNERSHIP OF TWTI IP AND TWTI MARKS. Subject to the rights granted
to ACLA in this Agreement, TWTI shall own the TWTI IP and the TWTI Marks.
30
6.2 PATENT PROSECUTION.
(A) First Right To Prosecute. Subject to Section 6.2(b), TWTI
(itself or through a designee) shall have the sole right to control the filing,
prosecution and maintenance of Patents within the TWTI IP, and shall bear all
costs associated therewith. TWTI shall consider comments from ACLA regarding
steps that might be taken to strengthen patent protection with respect to any
Patent within such TWTI IP or to expand protection in a mutually desired manner.
Nothing herein shall imply or create any obligation for TWTI to file, prosecute,
obtain or maintain any Patents or to follow ACLA's recommendations or comments.
(B) Election Not to Prosecute or Maintain. Without limiting
Section 6.2(a) above, TWTI may elect, on a country-by-country basis, not to
continue to prosecute and thereby abandon an application for a Patent within the
TWTI IP, or not to maintain and thereby abandon such a Patent. With respect to
issued Patents only, TWTI shall notify ACLA of such election and discuss with
ACLA the possibility of allowing ACLA the right to maintain, in such country or
jurisdiction, such issued Patent. Nothing herein shall imply or create any
obligation for TWTI to file, prosecute, obtain or maintain any Patents nor grant
to ACLA any right to do so.
6.3 PATENT MARKING. ACLA shall xxxx, and cause the ACLA Entities and
Technology Access Partners and Enabled Customers to xxxx, Licensed Products,
Probe Sets and Cleavase Enzyme with the numbers of the Patents covering the same
as may be necessary or appropriate to preserve TWTI's rights under applicable
law and regulations in applicable countries. In this regard, ACLA will consult
with TWTI from time to time regarding such markings.
6.4 ENFORCEMENT OF INTELLECTUAL PROPERTY.
(A) Notice. If ACLA believes in good faith that a Third Party
that is a significant competitor is engaged in sales or uses of a Competing
Product (as defined below) in a given country, and that Competing Product
infringes the TWTI IP in such country, then ACLA shall promptly notify TWTI in
writing of such infringement, describing in such notice in reasonable detail
ACLA's Corresponding Licensed Product (as defined below), the Competing Product
and the Enforceable Patents (as defined below) included in the TWTI IP that ACLA
believes are infringed. For purpose of this Section 6.4, (i) "Competing Product"
means a product that infringes an Enforceable Patent in the TWTI IP and is
functionally equivalent to a Licensed Product being marketed and sold by ACLA
for use in the country identified in ACLA's notice (the "Corresponding Licensed
Product"); (ii) "Enforceable Patent" means a Patent in such country which is
included in the TWTI IP and which TWTI has the power and authority to enforce as
contemplated in this Section 6.4; and (iii) the term "significant competitor"
means a Third Party who is not, and is not Affiliated with, any ACLA Entity,
Technology Access Partner, or Enabled Customer and whose total revenues from its
sales of such Competing Product in a given country that are used in such country
are greater than or equal to *** of the total aggregate amount of the ACLA
Entities' Net Sales and Other Consideration from sales of the Corresponding
Licensed Product in such country in the most recent twelve (12) consecutive
calendar month period, provided that the ACLA Entities' Net Sales and Other
Consideration from the sales of the Corresponding Licensed Product that are used
in such country exceeds *** during such period.
31
(B) Right to Enforce TWTI IP. TWTI (itself or through a designee) shall
have the sole right, but not the obligation, to enforce and control the
enforcement of the TWTI IP. With respect to enforcement by TWTI of an
Enforceable Patent in the TWTI IP against a significant competitor with respect
to a Competing Product for which TWTI has received notice from ACLA in
accordance with Section 6.4(a), TWTI shall keep ACLA reasonably informed on a
reasonably timely basis, and reasonably consult with ACLA and consider in good
faith the reasonable comments of ACLA, regarding such enforcement, both prior to
and during any such enforcement. ACLA shall assist TWTI and provide information,
upon request, and to the extent commercially reasonable for ACLA, in taking any
action to enforce the TWTI IP. Amounts invoiced by ACLA on sales, after the
occurrence of a Toll Event (as defined below), of Corresponding Licensed Product
shall be excluded from Net Sales for units used in the country in which the Toll
Event occurred, but only until such time as the Toll Event has been remedied in
the applicable country and TWTI has so notified ACLA thereof in writing.
Notwithstanding anything to the contrary, no amounts shall be excluded from Net
Sales, and no Toll Event shall be considered to have occurred, if ACLA has
failed to provide information or assistance reasonably requested by TWTI or if
there is a difference between the Corresponding Licensed Product and the
Competing Product that provides a reasonable basis for concluding that the
Competing Product does not infringe the Enforceable Patent even if the
Corresponding Licensed Product does infringe. ACLA shall provide TWTI with
technical details concerning the Competing Product and Corresponding Licensed
Product sufficient to enable TWTI to understand fully the two products, and
their functionality and composition, and to establish infringement by the
Competing Product. As used herein, a "Toll Event" shall be deemed to have
occurred if ACLA has provided TWTI with notice of a Competing Product and
infringement in accordance with Section 6.4(a), Competing Product used in the
country identified in ACLA's notice continues to be sold by an entity that is a
significant competitor in such country with respect to such Competing Product,
and either of the following is true: (X) TWTI (itself or through a designee) has
not, within one hundred eighty (180) days after receiving such notice from ACLA
under Section 6.4(a), initiated actions to commence one of a lawsuit against,
negotiations for a license with, or other reasonable enforcement of an
Enforceable Patent against such entity with respect to the applicable Competing
Product in the applicable country or (Y) TWTI (itself or through a designee) has
not, within one (1) year after such notice, executed with such significant
competitor a license or other authorization under the infringed Enforceable
Patent, and has not within such period commenced a lawsuit against such
significant competitor, each with respect to the Competing Product in the
applicable country. A Toll Event shall be considered remedied if any of the
following occurs: TWTI has executed a license or other authorization for the
Competing Product in the applicable country; TWTI has commenced a lawsuit; the
entity that was a significant competitor is no longer a significant competitor
in the applicable country with respect to the applicable Competing Product; TWTI
no longer has the power or authority to enforce the Enforceable Patent in the
applicable country against the significant competitor with respect to the
Competing Product through no action of TWTI (such as without limitation as a
result of expiration of the Enforceable Patent, expiration of TWTI's exclusive
in-license, or otherwise); a reasonable non-infringement and/or invalidity
opinion has been provided by TWTI; or ACLA has failed to provide information or
assistance reasonably requested by TWTI. Nothing shall be construed to require
TWTI to bring an action based upon all of the Enforceable Patents that may be
infringed.
32
(C) Defense of TWTI IP. TWTI (itself or through a designee)
shall have the sole right, but not the obligation, to defend and control the
defense of the TWTI IP; provided, however, that if ACLA is a party to any such
action or proceeding regarding TWTI IP, ACLA shall have the right to conduct and
control its defense of itself and its Licensed Products at ACLA's cost and
expense, subject to Article 9. For clarity, the foregoing shall not be construed
to provide ACLA with any rights to enforce or defend any TWTI IP in any manner.
In such case where ACLA is a party, each Party shall keep the other informed on
a reasonably timely basis, and reasonably consult with the other and consider in
good faith the reasonable comments of the other, regarding such defense both
prior to and during any such defense. ACLA shall assist TWTI and provide
information, upon request, and to the extent commercially reasonable for ACLA,
in taking any action to defend the TWTI IP.
ARTICLE 7
CONFIDENTIALITY
7.1 CONFIDENTIAL INFORMATION.
(A) Confidentiality Obligations. Each Party agrees that, for
the Term and thereafter for a period of five (5) years, such Party will keep,
and will ensure that its officers, directors, employees and agents keep,
completely confidential and will not publish or otherwise disclose and will not
use for any purpose except as permitted hereunder any Confidential Information
of the other Party. The foregoing obligations will not apply to any information
to the extent that it can be established by such receiving Party that such
information:
(I) was already known to the receiving Party as
evidenced by its written records, other than under an obligation of
confidentiality, at the time of disclosure;
(II) was generally available to the public or was
otherwise part of the public domain at the time of its disclosure to the
receiving Party;
(III) became generally available to the public or
otherwise becomes part of the public domain after its disclosure and other than
through any act or omission of the receiving Party in breach of this Agreement;
(IV) was subsequently lawfully disclosed to the
receiving Party by a Third Party other than under an obligation of
confidentiality and other than in contravention of a confidentiality obligation
of such Third Party; or
(V) was developed or discovered by employees of the
receiving Party or its Affiliates who had no access to the Confidential
Information of the disclosing Party as evidenced by the written records of the
receiving Party.
Each Party shall obtain written agreements from each of its employees,
consultants having access to the other Party's Confidential Information in
accordance with this Section 7.1.
(B) Permitted Use and Disclosures. Notwithstanding the
provisions of Section 7.1(a), each Party may disclose the other Party's
Confidential Information to the extent
33
such disclosure is reasonably necessary to comply with applicable governmental
laws, regulations, or orders; provided that if a Party is required to make any
such disclosure of the other Party's Confidential Information, it will, to the
extent it may legally do so, give reasonable advance notice to the latter Party
of such disclosure and will use its reasonable efforts to secure confidential
treatment of such information prior to its disclosure (whether through
protective orders or otherwise). Each Party shall also have the right to use the
Confidential Information of the other Party in accordance with licenses granted
in this Agreement. Each Party shall disclose the Confidential Information of the
other Party only to its employees, subcontractors, and sublicensees as
reasonably necessary for such Party to exercise its rights.
7.2 TERMS OF AGREEMENT; PRESS RELEASE. Except to the extent required by
applicable law or as otherwise permitted in accordance with this Section 7.2,
neither Party shall make any public announcements concerning this Agreement or
the terms hereof, including, without limitation, the existence and terms of the
rights grant under Sections 3.1, 3.2 and 3.5 above, without the prior written
consent of the other Party. Notwithstanding the foregoing, each Party shall have
the right to issue a press release in the form attached as Exhibit 7.2 and to
disclose this Agreement or the terms hereof (i) to advisors and investors on a
need-to-know basis under conditions which reasonably ensure the confidentiality
thereof; (ii) as required by any court or other governmental body; (iii) as
otherwise required by law; (iv) in confidence to legal counsel of such parties;
(v) in confidence, in connection with the enforcement of this Agreement or
rights under this Agreement; (vi) in confidence, in connection with a merger,
acquisition of stock or assets, proposed merger or acquisition, or the like; or
(vii) as required in connection with any government or regulatory filings,
including without limitation filings with the SEC, provided that such disclosing
Party shall: (A) give reasonable advance written notice to the non-disclosing
Party of the proposed disclosure and the reason for such disclosure; (B)
consider in good faith comments and requests of the non-disclosing Party
regarding such proposed disclosure that are received by the disclosing Party
within two (2) business days after the non-disclosing Party's receipt of the
proposed disclosure; and (C) use reasonable efforts to secure confidential
treatment of such disclosed information.
7.3 PUBLICATION. ACLA shall have the right to publish and present
information related to work performed pursuant to the rights granted ACLA under
Sections 3.1 and 3.5 above, provided that such information does not contain or
disclose Confidential Information of TWTI and provided further that, if such
information arises from activities pursuant to Section 3.5, TWTI approves such
publication or presentation, such permission not to be unreasonably withheld.
7.4 PROPRIETARY MARKINGS. Neither Party shall remove or obscure any
trademark, trade name, copyright notice, patent marking or other proprietary
notice from any materials provided to it by the other Party in connection with
this Agreement.
ARTICLE 8
REPRESENTATIONS AND WARRANTIES
8.1 REPRESENTATIONS BY TWTI. TWTI represents and warrants that it has
not previously granted and will not grant any rights in conflict with the rights
and licenses granted herein, and as of the Effective Date that: (i) it is duly
organized and validly existing under the
34
laws of the jurisdiction of its incorporation and has full corporate power and
authority to enter into this Agreement; (ii) it is in good standing with all
relevant governmental authorities; (iii) it has taken all corporate actions
necessary to authorize the execution and delivery of this Agreement and the
performance of its obligations under this Agreement; (iv) it has the rights to
grant the rights and licenses under Article 3; (v) it has no knowledge that the
Invader Reaction in and of itself infringes the Intellectual Property Rights of
any Third Party; (vi) it Controls no Intellectual Property Rights, other than
the TWTI IP, that are necessary to perform the Multiplexed Invader Application;
(vii) no Intellectual Property Rights have been in-licensed by TWTI that are
necessary to perform the Invader Reaction which are not Controlled by TWTI; and
(viii) the performance of its obligations under this Agreement do not conflict
with, or constitute a default under its charter documents, any contractual
obligation of TWTI or any court order.
8.2 REPRESENTATIONS BY ACLA. ACLA represents and warrants that, as of
the Effective Date: (i) it is duly organized and validly existing under the laws
of the jurisdiction of its incorporation and has full corporate power and
authority to enter into this Agreement; (ii) it is in good standing with all
relevant governmental authorities; (iii) it has taken all corporate actions
necessary to authorize the execution and delivery of this Agreement and the
performance of its obligations under this Agreement; and (iv) the performance of
its obligations under this Agreement do not conflict with, or constitute a
default under its charter documents, any contractual obligation of ACLA or any
court order.
8.3 DISCLAIMER OF WARRANTIES. EXCEPT AS SPECIFICALLY SET FORTH IN THIS
ARTICLE 8, NO PARTY MAKES ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED,
INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE OR USE, NON-INFRINGEMENT, AND ANY OTHER STATUTORY WARRANTY.
ARTICLE 9
INDEMNIFICATION
9.1 INDEMNIFICATION BY TWTI. TWTI shall indemnify, defend and hold ACLA
and its Affiliates, agents, employees, officers and directors (the "ACLA
Indemnitees") harmless from and against any and all liability, damage, loss,
cost or expense (including reasonable attorneys' fees) arising out of Third
Party claims or suits to the extent resulting from: (i) TWTI's performance of,
or failure to perform, its obligations under this Agreement; and (ii) breach by
TWTI of any of its representations and warranties under Section 8.1 above,
provided, however, that TWTI's obligations pursuant to this Section 9.1 will not
apply to the extent such claims or suits result from the negligence or willful
misconduct of any of the ACLA Indemnitees.
9.2 INDEMNIFICATION BY ACLA. Except for liability for which TWTI is
required to indemnify ACLA under Section 9.1 above, ACLA shall indemnify, defend
and hold TWTI and its Affiliates, agents, employees, officers and directors (the
"TWTI Indemnitees") harmless from and against any and all liability, damage,
loss, cost or expense (including reasonable attorneys' fees) arising out of
Third Party claims or suits to the extent resulting from: (i) ACLA's performance
of, or failure to perform, its obligations under this Agreement; (ii) breach by
ACLA of any of its representations and warranties under Section 8.2 above; or
(iii) product liability or
35
other claims arising from or in connection with the exercise or practice by any
of the ACLA Entities, any End User, Technology Access Partner, Enabled Customer,
or otherwise, of the rights and licenses granted by TWTI under this Agreement;
provided, however, that ACLA's obligations pursuant to this Section 9.2 will not
apply to the extent such claims or suits result from the negligence or willful
misconduct of any of the TWTI Indemnitees.
9.3 NOTIFICATION OF CLAIM; CONDITIONS TO INDEMNIFICATION
OBLIGATIONS. As a condition to a Party's right to receive indemnification under
this Article 9, it shall: (i) promptly notify ("Claim Notice") the other Party
as soon as it becomes aware of a claim or suit for which indemnification may be
sought pursuant hereto (provided that the failure to give a Claim Notice
promptly shall not prejudice the rights of an indemnified Party except to the
extent that the failure to give such prompt notice materially prejudices the
indemnifying Party); (ii) cooperate with the indemnifying Party in the defense
of such claim or suit, at the expense of the indemnifying Party, including
providing reasonable information; and (iii) if the indemnifying Party confirms
in writing to the indemnified Party its intention to defend such claim or suit
within ten (10) days of receipt of the Claim Notice, permit the indemnifying
Party to control the defense of such claim or suit, including without limitation
the right to select defense counsel; provided that if the indemnifying Party
fails to (x) provide such confirmation in writing within the ten (10) day period
or (y) diligently and reasonably defend such suit or claim at any time, its
right to defend the claim or suit shall terminate immediately in the case of (x)
and otherwise upon twenty (20) days' written notice to the indemnifying Party
without cure and the indemnified Party may assume the defense of such claim or
suit at the sole expense of the indemnifying Party and may settle or compromise
such claim or suit without the consent of the indemnifying Party. In no event,
however, may the indemnifying Party compromise or settle any claim or suit in a
manner which admits fault or negligence on the part of any indemnified Party or
that otherwise materially affects such indemnified Party's rights or requires
any payment by an indemnified Party without the prior written consent of such
indemnified Party. Subject as expressly provided above, the indemnifying Party
will have no liability under this Article 9 with respect to claims or suits
settled or compromised (including by admission) without its prior written
consent.
ARTICLE 10
TERM AND TERMINATION
10.1 TERM. This Agreement will commence upon the Effective
Date and shall continue in effect until the last-to-expire of any Valid Claim
within the TWTI IP unless earlier terminated as provided herein (the "Term").
10.2 TERMINATION FOR CONVENIENCE BY ACLA. ACLA shall have the
right to terminate this Agreement with immediate effect, unless otherwise
expressly specified hereunder, at any time with ninety (90) days prior written
notice.
10.3 TERMINATION FOR CAUSE BY TWTI. TWTI shall have the right
to terminate this Agreement upon final determination, in accordance with Section
11.8(c) below, of material failure to comply with any material term of this
Agreement by ACLA.
36
10.4 CONSEQUENCES OF TERMINATION OR EXPIRATION.
(A) RETURN OF MATERIALS. Upon termination or expiration of
this Agreement each Party will promptly return all records and materials in its
possession or control containing or comprising the other Party's know-how or
other Confidential Information to which the former Party does not expressly
retain rights hereunder.
(B) ACCRUED LIABILITY. Termination or expiration of this
Agreement for any reason shall not release either Party hereto from any
liability which at the time of such termination or expiration has already
accrued to the other Party prior to such time. Such termination or expiration
will not relieve a Party from accrued payment obligations or from obligations
which are expressly indicated in this Agreement to survive termination or
expiration of this Agreement.
(C) SURVIVAL. The following Articles and Sections of this
Agreement shall survive its termination or expiration: Articles 1, 5 (for a
period of three (3) years after termination or expiration), 7, 9 and 11 and
Sections 3.6(a) (third sentence), 3.6(d) (last sentence), 3.9, 4.1(b), 4.1(c),
8.3, and 10.4. Except as otherwise expressly indicated in this Agreement, all
rights and licenses shall terminate upon any expiration or termination of this
Agreement. For clarity, all rights of ACLA under Articles 3 and 7, all rights of
Resellers, Value Added Distributors, Manufacturing Distributors, Technology
Access Partners, and Enabled Customers, shall terminate upon any termination or
expiration of this Agreement. No ACLA Entity shall distribute Licensed Product,
Cleavase Enzyme, or Probe Set, as applicable, after any termination or
expiration of this Agreement.
ARTICLE 11
GENERAL PROVISIONS
11.1 RELATIONSHIP OF THE PARTIES. The Parties are independent
contractors. Nothing in this Agreement is intended or will be deemed to
constitute a partnership, agency or employer-employee relationship between the
Parties. Neither Party will incur any debts or make any commitments for the
other Party.
11.2 ASSIGNMENTS. Except as expressly provided herein, neither this
Agreement nor any interest hereunder will be assignable, nor any other
obligation delegable, by a Party without the prior written consent of the other
Party; provided, however, that a Party shall have the right to assign and
otherwise transfer this Agreement as a whole without consent to any successor
that acquires all or substantially all of the business or assets of such Party
by way of merger, consolidation, other business reorganization, or the sale of
stock or assets, provided that the assigning Party notifies the other Party in
writing of such assignment, both the Supply Agreement and InvaderCreator Access
Agreement are concurrently transferred in their entirety to such successor in
accordance with their terms, and such successor agrees in writing to be bound by
the terms and conditions of this Agreement, the Supply Agreement and the
InvaderCreator Access Agreement. This Agreement shall be binding upon successors
and permitted assigns of the Parties. Any assignment not in accordance with this
Section 11.2 will be null and void.
37
11.3 INTENTIONALLY OMITTED.
11.4 FORCE MAJEURE. Except with respect to payment of money, no Party
shall be liable to the other for failure or delay in the performance of any of
its obligations under this Agreement for the time and to the extent such failure
or delay is caused by earthquake, riot, civil commotion, war, terrorist acts,
strike, flood, or governmental acts or restriction, or other cause that is
beyond the reasonable control of the respective Party. The Party affected by
such force majeure will provide the other Party with full particulars thereof as
soon as it becomes aware of the same (including its best estimate of the likely
extent and duration of the interference with its activities), and will use
commercially reasonable efforts to overcome the difficulties created thereby and
to resume performance of its obligations as soon as practicable. If the
performance of any such obligation under this Agreement is delayed owing to such
a force majeure for any continuous period of more than one hundred eighty (180)
days, the Parties hereto will consult with respect to an equitable solution,
including the possibility of the mutual termination of this Agreement.
11.5 ENTIRE AGREEMENT OF THE PARTIES; AMENDMENTS. This Agreement, the
Supply Agreement, the InvaderCreator Access Agreement, the Letter related to the
Transition Manufacturing Plan and the Letter related to InvaderCreator Access
Prior to Implementation of Updates, all entered into concurrently, constitute
and contain the entire understanding and agreement of the Parties respecting the
subject matter hereof and except as expressly provided in Section 2.1 of this
Agreement cancels and supersedes any and all prior and contemporaneous
negotiations, correspondence, understandings and agreements between the Parties,
whether oral or written, regarding such subject matter, including, without
limitation, the Development and Commercialization Agreement. No waiver,
modification or amendment of any provision of this Agreement will be valid or
effective unless made in writing and signed by the Parties.
11.6 CAPTIONS. The captions to this Agreement are for convenience only,
and are to be of no force or effect in construing or interpreting any of the
provisions of this Agreement.
11.7 GOVERNING LAW. This Agreement will be governed by and interpreted
in accordance with the laws of the State of California, applicable to contracts
entered into and to be performed wholly within the State of California,
excluding conflict of laws principles.
11.8 DISPUTE RESOLUTION.
(A) General. Except as otherwise provided in this Section 11.8
below, in the event of any controversy or claim arising out of, relating to or
in connection with any provision of this Agreement or the rights or obligations
of the Parties hereunder, either Party shall have the right to initiate dispute
resolution by sending written notice of the dispute, and an intent to arbitrate
such dispute, to the other Party; provided, however, that any dispute concerning
the scope, construction, validity, enforceability or infringement of any Patent
within the TWTI IP shall be heard and decided in a court of competent
jurisdiction under the local patent laws of the jurisdictions having issued the
Patent or Patents in question. Within twenty (20) days after such notice
(either, a "Dispute Notice"), each Party shall cause its Chief Executive Officer
or the Chief Executive Officer's high-level executive (at the senior vice
president level or higher) to meet in person to negotiate in good faith a
resolution to the dispute within twenty (20) days of
38
the first such meeting. If the dispute is unresolved during such period, then
any Party may initiate arbitration in accordance with the commercial arbitration
rules of the American Arbitration Association ("AAA") then in force. The Parties
shall use their commercially reasonable efforts to conclude the arbitration
within six (6) months after the arbitrator has been appointed. The venue of such
arbitration shall be in Madison, Wisconsin for disputes brought by ACLA and
Santa Xxxxx County, California for disputes brought by TWTI.
(B) Fast Track. In the event of any dispute related to ACLA's
rights to suspend payments under Section 6.4(b), then either Party shall have
the right to issue a Dispute Notice as provided under Section 11.8(a) above
identifying the nature of such dispute and that such Party believes in good
faith that such dispute should be decided pursuant to this Section 11.8(b);
provided, however, that any dispute related to the infringement, validity or
claim construction of any Patents shall be heard by a court of competent
jurisdiction in the country where such right exists. The Parties shall agree
upon and appoint one (1) arbitrator within twenty (20) days after the notice of
arbitration is received by all Parties and, failing such agreement, any Party
may apply under the applicable rules of the AAA for the appointment of an
arbitrator and the selection of an arbitrator under such rules of the AAA shall
be final and binding on the Parties. Such arbitrator shall have appropriate
experience in the biopharmaceutical industry and be independent of all the
Parties. Within thirty (30) days after such arbitrator is identified and
retained in writing, each Party shall submit to such arbitrator and the other
Party a written proposal for resolving such dispute. The arbitrator shall select
the proposal of one Party without alteration or modification, which proposal
shall be deemed the judgment and award with respect to such dispute. The
arbitrator shall limit discovery as reasonably practicable to complete the
arbitration as soon as practicable.
(C) Judgments. An award rendered pursuant to this Section 11.8
shall be final and binding upon all parties participating in such arbitration.
The arbitrator may, upon competent proof, grant any remedy or relief that the
arbitrator deems just and equitable under the terms and conditions of this
Agreement. Nothing in this Agreement shall be deemed as preventing any Party
from seeking injunctive relief (or any other provisional remedy) from any court
having jurisdiction over the Parties and the subject matter of the dispute.
Judgment upon the award may be entered in any court having jurisdiction, or
application may be made to such court for judicial acceptance of the award
and/or an order of enforcement as the case may be and shall be deemed to be a
final determination.
(D) Preliminary Injunctions. Notwithstanding anything to the
contrary in this Section 11.8, a Party shall have the right to seek a temporary
restraining order or preliminary injunction from any court of competent
jurisdiction in order to prevent immediate and irreparable injury, loss or
damage on a provisional basis, pending the decision of the arbitrator(s) on the
merits under this Section 11.8.
11.9 NOTICES AND DELIVERIES. Any notice, request, delivery, approval or
consent required or permitted to be given under this Agreement will be in
writing and will be deemed to have been sufficiently given if delivered in
person, transmitted by telecopier (receipt verified) or by express courier
service (signature required) or five (5) days after it was sent by registered
letter, return receipt requested (or its equivalent), provided that no postal
strike or other disruption is then in effect or comes into effect within two (2)
days after such mailing, to the
39
Party to which it is directed at its address or facsimile number shown below or
such other address or facsimile number as such Party will have last given by
notice to the other Party.
If to TWTI, addressed to:
Third Wave Technologies, Inc.
000 Xxxxx Xxxx Xxxx
Xxxxxxx, Xxxxxxxxx 00000
Attn.: President
Fax: 000-000-0000
With a copy to:
Xxxxxx Xxxxxxx Xxxxxxxx & Xxxxxx
000 Xxxx Xxxx Xxxx
Xxxx Xxxx, Xxxxxxxxxx 00000-0000
Attn.: Xxx X. Xxxxxxxx, Esq.
Fax: 000-000-0000
If to ACLA, addressed to:
ACLARA BioSciences, Inc.
0000 Xxxx Xxxxxx
Xxxxxxxx Xxxx, Xxxxxxxxxx 00000
Attn.: President and CEO
Fax: 000-000-0000
With a copy to:
Xxxxxx & Xxxxxxx
000 Xxxxxxxxxxxx Xxxxx
Xxxxx Xxxx, Xxxxxxxxxx 00000
Attn.: Xxxxxxx X. Xxxx, Esq.
Fax: 000-000-0000
11.10 NO CONSEQUENTIAL DAMAGES. EXCEPT WITH RESPECT TO UNAUTHORIZED
EXPLOITATION OF THE OTHER PARTY'S INTELLECTUAL PROPERTY RIGHTS, BREACH OF
ARTICLE 7, BUT INCLUDING UNDER ARTICLE 9, IN NO EVENT WILL ANY PARTY OR ANY OF
ITS RESPECTIVE AFFILIATES BE LIABLE TO THE ANY OTHER PARTY OR ANY OF ITS
AFFILIATES FOR SPECIAL, INDIRECT, CONSEQUENTIAL, INCIDENTAL, EXEMPLARY, OR
PUNITIVE DAMAGES, WHETHER IN CONTRACT, WARRANTY, TORT, NEGLIGENCE, STRICT
LIABILITY OR OTHERWISE, INCLUDING BUT NOT LIMITED TO, LOSS OF PROFITS OR REVENUE
OR CLAIMS OF CUSTOMERS OF ANY OF THEM OR OTHER THIRD PARTIES FOR SUCH DAMAGES.
40
11.11 WAIVER. A waiver by any Party of any of the terms and conditions
of this Agreement in any instance will not be deemed or construed to be a waiver
of such term or condition for the future, or of any subsequent breach hereof.
All rights, remedies, undertakings, obligations and agreements contained in this
Agreement will be cumulative and none of them will be in limitation of any other
remedy, right, undertaking, obligation or agreement of either Party.
11.12 SEVERABILITY. When possible, each provision of this Agreement
will be interpreted in such manner as to be effective and valid under applicable
law, but if any provision of this Agreement is held to be prohibited by or
invalid under applicable law, such provision will be ineffective only to the
extent of such prohibition or invalidity, without invalidating the remainder of
this Agreement. The Parties will make a good faith effort to replace the invalid
or unenforceable provision with a valid one which in its economic effect is most
consistent with the invalid or unenforceable provision. In the event a Party
seeks to avoid a provision of this Agreement by asserting that such provision is
invalid, illegal or otherwise unenforceable, the other Party shall have the
right to terminate this Agreement upon sixty (60) days' prior written notice to
the asserting Party, unless such assertion is eliminated and cured within such
sixty (60)-day period, such termination shall be deemed to be a termination
pursuant to Section 10.2 if by ACLA or if by TWTI pursuant to Section 10.3.
11.13 COMPLIANCE WITH LAWS. Notwithstanding anything to the contrary
contained herein, all rights and obligations of ACLA and TWTI are subject to
prior compliance with, and each Party shall comply with, all United States and
foreign export and import laws, regulations, and orders, and such other United
States and foreign laws, regulations, and orders as may be applicable, including
obtaining all necessary approvals required by the applicable agencies of the
governments of the United States and foreign jurisdictions.
11.14 COUNTERPARTS. This Agreement may be executed simultaneously in
any number of counterparts, any one of which need not contain the signature of
more than one Party but all such counterparts taken together will constitute one
and the same agreement.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be
executed by their respective duly authorized officers as of the Effective Date,
each copy of which will for all purposes be deemed to be an original.
THIRD WAVE TECHNOLOGIES, INC. ACLARA BIOSCIENCES, INC.
By: __________________________ By: _______________________________
Name: _______________________ Name: _____________________________
Title: ____________________ Title: _______________________
Date: _____________________ Date: _______________________
41
EXHIBIT 1.48
TWTI PATENTS
U.S. Patent Nos.
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EXHIBIT 1.49
TWTI MARKS
[To be attached]
EXHIBIT 7.2
PRESS RELEASE
FOR IMMEDIATE RELEASE
ACLARA Contact: Xxxxxx Xxxxxxxxxxxx
VP, Finance and CFO
650.210.1200
xxxxxxxxxxxxx@xxxxxx.xxx
Third Wave Contact:: Xxx Xxxx
Manager, Corporate Communications
608.663.4010
xxxxx@xxx.xxx
ACLARA AND THIRD WAVE SIGN NEW LICENSE, SUPPLY AGREEMENTS
ACLARA licenses Third Wave's Invader(TM) technology to independently
develop and commercialize multiplexed gene expression research applications
MOUNTAIN VIEW, Calif. and MADISON, Wis.--October 16, 2002--ACLARA BioSciences
Inc. (Nasdaq: ACLA) and Third Wave Technologies Inc. (Nasdaq: TWTI) today
announced that they have entered into license and supply agreements under which
ACLARA will have rights to incorporate Third Wave's Invader(TM)technology and
Cleavase(R) enzyme with ACLARA's eTag(TM) technology to offer the eTag Assay
System for multiplexed gene expression applications for the research market.
The new business relationship allows ACLARA to directly develop and
commercialize its multiplexed eTag-Invader(TM) gene expression assays, greatly
streamlining the operational structure of the previous collaboration and
permitting ACLARA to fully exploit a large market with an unmet need. ACLARA's
products enable pharmaceutical and biotechnology companies to more efficiently
identify important drug targets and new medicines, and to characterize disease
status and treatment.
In addition to licensing the Invader technology platform to ACLARA for
gene expression applications for research use, Third Wave will supply Cleavase
enzyme to ACLARA for incorporation into eTag-Invader gene expression assays.
"This new commercial relationship provides ACLARA with an enhanced
ability to address the sizable gene expression research market," said Xxxxxx X.
Xxxxxx, ACLARA's president and chief executive officer. "We plan to aggressively
develop this significant market opportunity. Researchers want an accurate,
efficient alternative for analyzing tens to hundreds of genes and eTag-Invader
gene expression assays are ideally suited for these types of experiments. With
our new agreement with Third Wave, ACLARA has greater flexibility to efficiently
commercialize these applications."
"We believe ACLARA's eTag chemistry with our Invader(R) assay is a
breakthrough detection technology for highly-multiplexed gene expression
analysis,"
said Xxxxx Xxxx, Ph.D., Third Wave chairman and chief executive officer. "The
Invader(TM) platform is increasingly becoming the platform of choice and this
license is one example of merging two great technologies to offer a
uniquely-differentiated, value-added product."
The powerful combination of eTag reporter molecules and the proven
Invader technology provides superior performance for profiling the expression of
many genes compared to other DNA and RNA detection methods. eTag-Invader
multiplexed, quantitative gene expression analyses are highly precise, accurate
and efficient, enabling researchers to obtain decision-critical results more
quickly and have greater success at detecting targets and drug response.
Researchers can easily perform these analyses at high throughput using far less
bio-sample and can compare results across different samples, experiments and
labs. They can profile many genes simultaneously in a single reaction directly
from crude cell lysates, without the need for sample preparation or polymerase
chain reaction (PCR) and with built-in internal controls.
The agreement provides ACLARA with a license for Third Wave's Invader
technology platform for multiplexed gene expression analysis in the research
market. In exchange, ACLARA will make undisclosed upfront payments and will make
royalty payments to Third Wave on sales of eTag-Invader gene expression assays.
The agreements supersede the previously announced collaboration agreement
between the two companies.
ABOUT ACLARA
ACLARA BioSciences, Inc. is developing advanced tools for drug discovery,
genomics and proteomics using its proprietary eTag(TM) assay chemistries and
microfluidics expertise. The Company's products allow researchers to have
decision-critical information for drug development, which previously was
difficult or impossible to obtain. The solution-phase eTag Assay System is
cost-effective, easy-to-use and flexible, and enables highly accurate and
precise analysis of genes and/or proteins from limited biological samples.
Importantly, researchers can use their existing instrument platforms to perform
eTag analyses. More information on ACLARA can be obtained on the Company's web
site at xxx.xxxxxx.xxx.
ABOUT THIRD WAVE TECHNOLOGIES
Third Wave Technologies develops, manufactures and markets genetic analysis
products that are accelerating the delivery of personalized medicine. Our
patented Invader product platform offers unmatched accuracy, sensitivity, ease
of use and cost-effectiveness, making it the ideal solution for genetic analysis
across the health care continuum.
For more information about Third Wave and its products, please visit the
company's website at xxxx://xxx.xxx.xxx.
Forward-Looking Statements
ALL STATEMENTS IN THIS NEWS RELEASE THAT ARE NOT HISTORICAL ARE FORWARD-LOOKING
STATEMENTS WITHIN THE MEANING OF THE SECURITIES EXCHANGE ACT OF 1934 AS AMENDED.
SUCH FORWARD-LOOKING STATEMENTS ARE SUBJECT TO FACTORS THAT COULD CAUSE ACTUAL
RESULTS FOR ACLARA AND/OR THIRD WAVE TO DIFFER MATERIALLY FROM THOSE PROJECTED.
THOSE FACTORS INCLUDE RISKS AND UNCERTAINTIES RELATING TO TECHNOLOGICAL
APPROACHES OF ACLARA AND THIRD WAVE, RESPECTIVELY, AND THEIR RESPECTIVE
COMPETITORS, PRODUCT DEVELOPMENT PLANS AND EFFORTS, MANUFACTURING CAPABILITIES,
MARKET ACCEPTANCE OF THEIR RESPECTIVE PRODUCTS, SUCCESSFUL ESTABLISHMENT OF AND
PERFORMANCE UNDER COLLABORATIVE AND COMMERCIAL AGREEMENTS, ADOPTION OF THEIR
RESPECTIVE TECHNOLOGIES BY PHARMACEUTICAL AND BIOTECHNOLOGY COMPANIES, ACLARA'S
ABILITY TO SUCCESSFULLY BUILD A DIRECT SALES AND MARKETING ORGANIZATION, AND
OTHER RISK FACTORS IDENTIFIED IN THE FORMS 10-K FOR THE YEAR ENDED DECEMBER 31,
2001, AND FORMS 10-Q FOR THE QUARTER ENDED JUNE 30, 2002, AS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION BY ACLARA AND THIRD WAVE, RESPECTIVELY.
TRADEMARKS
ACLARA BioSciences, eTag, and the ACLARA logo are trademarks of ACLARA
BioSciences, Inc. Invader and Cleavase are registered trademarks of Third Wave
Technologies Inc.
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