Exhibit 10.32
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:
Confidential treatment has been requested for portions of this exhibit. The copy
filed herewith omits the information subject to the confidentiality request.
Omissions are designated as * * *. A complete version of this exhibit has been
filed separately with the Securities and Exchange Commission.
1
ARTICE 1
Definitions
Capitalized terms not otherwise defined herein will have the meaning
set forth below:
1.1 "Aclara Component" means an Aclara Precursor from a library that,
when the Aclara Precursor is incorporated into a*** which has been*** an***,
allows the*** to be separated by*** from other*** that each incorporate an
Aclara Precursor from the library. As used herein, "Aclara Precursors" shall
mean*** specifically designed and suitable for use to construct a library of
such*** by*** where each member of the library can be differentiated from the
other members by its***.
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,
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the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
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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.
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.
3
1.11 "Diagnostic Procedure" means a use for which a purpose is to***
regarding an individual or a sample from an individual for:***. For the sake of
clarity, Diagnostic Procedures exclude***
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 design and manufacture Probe Sets; (ii) in which
ACLA grants to such Third Party a sublicense under Section 3.1(b) below, but
which sublicense is limited to*** in which*** were*** under the sublicense
described in sub-paragraph (i) of this Section 1.12 above, or*** by such Third
Party from a*** and in which*** is*** by such Third Party directly from***;
(iii) which prohibits such Third Party from*** under the sublicense described in
sub-paragraph (i) of this Section 1.12 above, or*** other than use by or on
behalf of such Third Party,*** under the sublicense described in sub-paragraph
(ii) of this Section 1.12 above, to perform*** in the Gene Expression Field;
(iv) which prohibits such Third Party from*** in any manner*** obtained from***
other than use by or on behalf of such Third Party,***, to perform***; 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 *** in which the *** incorporates *** in lieu
of or attached to the one or more *** that may be included in the ***.
1.16 "Flap" shall have the meaning assigned in Section 1.25 below.
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***. For clarity, "Gene Expression
Field" excludes***. For the sake of clarity, Gene Expression Field includes***.
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the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
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1.19 "Genotyping Field" means***. For clarity, "Genotyping Field"
excludes***.
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 *** of a *** that is *** that ***.
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.
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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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the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
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1.24 "Invader Probe" means an oligonucleotide probe/1/ 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) ***;
(ii) the ***; and (iii) ***. 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 based upon or uses the *** or (ii) employs any ***.
For purposes of this Section 1.25, "SST Technology" shall mean any and all ***
together with any and all subject matter claimed in Patents based on such
patents or subject matter; and "Bridging Oligonucleotide" shall mean an ***.
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
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/1/ 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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the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
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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 to manufacture*** by such Third Party;
(ii) in which ACLA grants to such Third Party a sublicense under Section 3.1(e)
below to***; (iii) which prohibits such Third Party from*** other than to ***;
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 combining only*** and***
in a*** that contains a*** all as necessary to perform in such*** on*** in
such***, wherein*** are generated only by (i)*** with respect to a*** from
the*** as a result of the*** with respect to other*** and then (ii)*** the
Aclara Components incorporated in such*** to determine the*** of*** with***.
Notwithstanding anything to the contrary, Multiplex Invader Application
shall***. Except with respect to***, Multiplexed Invader Application shall***.
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
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the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
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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 ***. 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.
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 *** probe comprising (A) ***; and (B) ***,
and may incorporate other *** including an Aclara Component. For purposes of
this Section 1.35, "complementary" requires that the region of the *** be fully
complementary to the ***, however such *** may be non-complementary to one or
more other nucleotide
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the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
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sequences that are highly homologous to the Primary Target (such other
nucleotide sequences, "Other Targets") also present in a sample such that the
*** may be used to detect and or quantify both *** and the *** 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 ***, 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) appoints such Third Party as an authorized
reseller*** to*** obtained***, (B) grants to such Third Party a*** to***
obtained***, and/or (C) grants to such Third Party a*** to *** obtained***; (ii)
which prohibits such Third Party from*** other than to*** solely for*** where
applicable; and (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 (i) in which ACLA grants to such Third Party a*** and***; (ii) which
prohibits such Third Party from*** other than*** to perform a***; and (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.
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the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
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1.42 "Target" means (i) when used for purposes of or in connection with
the licenses under Section 3.1, any *** that is in the Gene Expression Field and
is of *** in a Multiplex Invader Application; and (ii) when used for purposes of
or in connection with the license under Section 3.5 only, any *** that is in the
Genotyping Field and is *** 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, 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 claiming any composition, method, product, or
improvement thereof that is or are necessary to practice, or primarily directed
at practicing, the Multiplex Invader Application. 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 the sake of clarity, nothing in this Section 1.48 shall***. For
purposes of this Section 1.48, "primarily directed at practicing" means any and
all***.
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.
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
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the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
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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 to ***; (ii) in which ACLA grants to such
Third Party a***; (iii) which prohibits such Third Party from*** other than
to***; 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.
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the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
11
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, *** in
the Gene Expression Field that are included in a *** as set forth in Section
3.1(b) and used solely as part of a *** 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 *** 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 ***
and *** 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
*** 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 *** 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 *** 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
***-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 Cleavage Enzymes not obtained pursuant to the Supply
Agreement)
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the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
12
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.
13
(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 (i)*** and (ii) *** provided that in
each case the Reseller has entered into a Reseller Agreement with ACLA. 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: (i)*** and (ii)*** as part of Licensed Product
created by the Enabled Customer all in accordance with this Agreement, provided
that in each case the Value Added Distributor has
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the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
14
entered into a Value Added Distributor Agreement with ACLA. 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)*** and (ii)*** for use
by*** 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 *** 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 ***-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: (i)*** and (ii) to***. All*** by an Enabled Customer, and
all***, shall be used solely by that Enabled Customer in ***, provided that in
each case the Enabled Customer has entered into a Enabled Customer Agreement
with ACLA. 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 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 *** 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 ***-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
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the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
15
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***, provided
that in each case the Technology Access Partner has entered into a TAP Agreement
with ACLA. All *** by a Technology Access Partner, and all*** by a Technology
Access Partner, shall be used solely by that Technology Access Partner in***.
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, 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
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the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
16
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 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
17
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 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
18
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. a*** under the ACLA IP***, to*** any and all***
for***. As used herein, "ACLA IP" shall mean i)***; and (ii)***; and
(b) Necessary Claims. a*** under*** for*** as necessary to
exercise the license in Section 3.9(a). The foregoing license includes ***.
Pursuant to this Section 3.9(b) and subject to the provisions of this Section
3.9, TWTI shall pay to ACLA a royalty of*** on TWTI Net Sales.
(c) Definitions. For purposes of Section 3.9(b) the following
terms shall have the definitions set forth elow:
(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).
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the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
19
(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 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
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the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
20
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. The Parties acknowledge that certain rights in
the TWTI IP may be***. TWTI covenants that it shall***.
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
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*** Certain information on this page has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
21
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 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.
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*** Certain information on this page has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
22
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
-------------------------------------------------------------------
(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
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*** Certain information on this page has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
23
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 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
__________________
*** Certain information on this page has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
24
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 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
____________
*** Certain information on this page has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
25
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*** 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.
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
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*** Certain information on this page has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
26
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 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.
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
27
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 is 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 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
28
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.
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
29
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 *** (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 *** 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.
(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
_____________
*** Certain information on this page has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
30
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 *** 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 *** 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.
(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.
______________
*** Certain information on this page has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
31
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 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
32
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 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.
33
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 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
34
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.
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.
35
(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.
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
36
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 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
37
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 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
38
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.
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
39
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: ______________________________
40
Exhibit 1.48
TWTI Patents
U.S. Patent Nos.
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*** Certain information on this page has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
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 supercede 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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